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Full text of "Radiation experiments conducted by the University of Cincinnati Medical School with Department of Defense funding : hearing before the Subcommittee on Administrative Law and Governmental Relations of the Committee on the Judiciary, House of Representatives, One Hundred Third Congress, second session, April 11, 1994"

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lDiation experiments conducted by the 
university of cincinnati medical school 

WITH DEPARTMENT OF DEFENSE FUNDING 



HEARING 

BEFORE THE 

SUBCOMMITTEE ON ADMINISTRATIVE LAW 
AND GOVERNMENTAL RELATIONS 

OF THE 

COMMITTEE ON THE JUDICIAKY 
HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRD CONGRESS 
SECOND SESSION 




84-514 



hS. GOVERNMENT PRINTING OFFICE 
WASHINGTON : 1994 



For sale by the U.S. Government Printing Office 
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402 
ISBN 0-16-046348-3 



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« ^ / / 



RADIATION EXPERIMENTS CONDUCTED BY THE 
UNIVERSITY OF CINCINNATI MEDICAL SCHOOL 
WITH DEPARTMENT OF DEFENSE FUNDING 



HEARING 

BEFORE THE 

SUBCOMMITTEE ON ADMINISTRATIVE LAW 
AND GOVERNMENTAL RELATIONS 

OF THE 

COMMITTEE ON THE JUDICIARY 
HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRD CONGRESS 

SECOND SESSION 



APRIL 11, 1994 



Serial No. 67 




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84-514 



i.S. GOVERNMENT PRINTING OFFICE 
WASHINGTON : 1994 



For sale by the U.S. Government Printing Office 
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402 
ISBN 0-16-046348-3 



COMMITTEE ON THE JUDICIARY 



JACK BROOKS, 
DON EDWARDS, California 
JOHN CONYERS, Jr., Michigan 
ROMANO L. MAZZOLI, Kentucky 
WILLIAM J. HUGHES, New Jersey 
MIKE SYNAR, Oklahoma 
PATRICIA SCHROEDER, Colorado 
DAN GLICKMAN, Kansas 
BARNEY FRANK, Massachusetts 
CHARLES E. SCHUMER, New York 
HOWARD L. BERMAN, California 
RICK BOUCHER, Virginia 
JOHN BRYANT, Texas 
GEORGE E. SANGMEISTER, lUinois 
CRAIG A WASHINGTON, Texas 
JACK REED, Rhode Island 
JERROLD NADLER, New York 
ROBERT C. SCOTT, Virginia 
DAVID MANN, Ohio 
MELVIN L. WATT, North CaroUna 
XAVIER BECERRA, California 



Texas, Chairman 

HAMILTON FISH, Jr., New York 
CARLOS J. MOORHEAD, California 
HENRY J. HYDE, Illinois 
F. JAMES SENSENBRENNER, Jr., 

Wisconsin 
BILL McCOLLUM, Florida 
GEORGE W. GEKAS, Pennsylvania 
HOWARD COBLE, North CaroUna 
LAMAR S. SMITH, Texas 
STEVEN SCHIFF, New Mexico 
JIM RAMSTAD, Minnesota 
ELTON GALLEGLY, CaUfomia 
CHARLES T. CANADY, Florida 
BOB INGLIS, South CaroUna 
BOB GOODLATTE, Virginia 



Jonathan R Yarowsky, General Counsel 

Robert A. Lembo, Counsel /Administrator 

Alan F. Coffey, Jr., Minority Chief Counsel 



Subcommittee on Administrative Law and Governmental Relations 



JOHN BRYANT, Texas, Chairman 

GEORGE W. GEKAS, Pennsylvania 
JIM RAMSTAD, Minnesota 
BOB INGLIS, South CaroUna 
BOB GOODLATTE, Virginia 



DAN GLICKMAN, Kansas 
BARNEY FRANK, Massachusetts 
HOWARD L. BERMAN, CaUfomia 
DAVID MANN, Ohio 
MELVIN L. WATT, North CaroUna 

Paul J. Drolet, Counsel 

David Naimon, Assistant Counsel 

NiCHOLE Jenkins, Assistant Counsel 

Raymond V. Smietanka, Minority Counsel 



(U) 



CONTENTS 



HEARING DATE 



Page 

April 11, 1994 1 

OPENE^G STATEME^^^ 

Bryant, Hon. John, a Representative in Congress from the State of Texas, 
and chairman, Subcommittee on Administrative Law, and Grovemmental 
Relations 5 

WITNESSES 

Cox, James D., M.D., professor of radiotherapy, M.D. Anderson Cancer Cen- 
ter, and chairman. Radiotherapy Oncology Group 68 

Egilman, David, M.D., clinical assistant professor, Department of Conmiunity 

Medicine, Brown University 107 

Hager, Catherine, survivor daughter 19 

Larkins, Joseph, survivor son 17 

Nelson, Gloria, survivor granddaughter 19 

Saenger, Eugene, M.D., professor emeritus of radiology. University of Cin- 
cinnati 171 

Soper, Dr. Gordon K., Principal Deputy to the Assistant for the Secretary 

lor Atomic Energy, Department of Defense 27 

Steger, Joseph, president. University of Cincinnati, accompanied by Stanley 

M. Cheslev 81 

Stephens, Martha, Ph.D., professor of English, University of Cincinnati 147 

LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING 

Bryant, Hon. John, a Representative in Congress from the State of Texas, 
and chairman. Subcommittee on Administrative Law, and Governmental 

Relations: Opening statement 5 

Cox, James D., M.D., professor of radiotherapy, M.D. Anderson Cancer Cen- 
ter, and chairman, Radiotherapy Oncology Group: Prepared statement ........ 70 

E^lman, David, M.D., clinical assistant professor. Department of Community 

Medicine, Brown University: Prepared statement Ill 

Hager, Catherine, survivor daughter: Prepared statement 297 

Larkins, Joseph, survivor son: Prepared statement 294 

Mann, Hon. David, a Representative in Congress from the State of Ohio: 

Opening statement 10 

Nelson, Gloria, survivor granddaughter: Prepared statement 293 

Portman, Hon. Rob, a Representative in Congress from the State of Ohio: 

Prepared statement 14 

Saenger, Eugene, M.D., professor emeritus of radiology. University of Cin- 
cinnati: Prepared statement 177 

Soper, Dr. Gordon K., Principal Deputy to the Assistant for the Secretary 

for Atomic Energy, Department of Defense: Prepared statement 30 

Steger, Joseph, president. University of Cincinnati: Prepared statement 83 

Stephens, Martha, Ph.D., professor of English, University of Cincinnati: Pre- 
pared statement 150 

APPENDIX 
Material submitted for the hearing 293 



(III) 



RADIATION EXPERIMENTS CONDUCTED BY 
THE UNIVERSITY OF CINCINNATI MEDICAL 
SCHOOL WITH DEPARTMENT OF DEFENSE 
FUNDING 



MONDAY, APRIL 11, 1994 

House of Representatives, 
Subcommittee on Administrative Law 

AND Governmental Relations, 

Committee on the Judiciary, 

Cincinnati, OH. 

The subcommittee met, pursuant to notice, at 10 a.m., in court- 
room 2, room 822, U.S. Post Office and Courthouse, Fifth and Wal- 
nut Streets, Cincinnati, OH, Hon. John Bryant (chairman of the 
subcommittee) presiding. 

Present: Representatives John Bryant and David Mann. 

Also present: Representative Rob Portman. 

Staff present: David Naimon, assistant counsel; Nichole Jenkins, 
assistant counsel; and Ray Smietanka, minority counsel. 

OPENING STATEMENT OF CHAIRMAN BRYANT 

Mr. Bryant. Good morning, ladies and gentlemen and distin- 
guished guests. The subcommittee will come to order. 

The House Judiciary's Subcommittee on Administrative Law and 
GovemmentEd Relations meets today in Cincinnati to take testi- 
mony concerning the whole and partial body of radiation experi- 
ments conducted in Cincinnati General Hospital and the University 
of Cincinnati Medical Center between 1960 and 1991, and partially 
funded by the Department of Defense. 

This subcommittee has jurisdiction over compensation for claims 
against the Federal Government based on the Federal Govern- 
ment's wrongdoing and considered previous compensation legisla- 
tion such as the Civil Liberties Act of 1988, which compensates 
Japanese-Americans who were in internment camps during World 
War II, and the Radiation Exposure Compensation Act of 1990, 
which compensates the residents who lived downwind from a Ne- 
vada nuclear test site and participated in those tests by the Grov- 
emment. 

On February 2, 1994, the subcommittee held a hearing examin- 
ing the issue of Government-sponsored experiments performed on 
humans who did not give informed consent to the experiments, in- 
cluding separate tests involving radiation, mustard gas, LSD, and 
other chemical agents. 

(1) 



The allegations regarding the Cincinnati radiation experiments 
are very serious. If they are true, these human experiments could 
be the most egregious that have been brought to light yet. 

Our task is to examine these tests, determine whether the sub- 
jects gave informed consent to participating in such tests, and what 
harm resulted from the tests, and whether compensation is appro- 
priate. 

I would like to thank Congressman David Mann, a member of 
this subcommittee, for bringing the Cincinnati radiation experi- 
ments to the subcommittee's attention. I commend Congressmsin 
Mann's commitment and persistence for bringing these experi- 
ments to the forefront of the Congress and to the attention of the 
Clinton administration. 

I know he also has worked closely with the working group estab- 
lished by President Clinton to ensure these experiments get serious 
examination as part of that group's consideration. 

The subcommittee would also like to welcome Rob Portman to 
this subcommittee. While he is not a member of this specific sub- 
committee and the Judiciary Committee does not allow 
nonmembers to question witnesses at committee hearings, as chair- 
man I think it is appropriate in this instance for Congressman 
Portman to sit with the subcommittee based on his extensive in- 
volvement with this issue. I think Congressman Portman's involve- 
ment in this hearing is an unusual case and it does not set a prece- 
dent for future subcommittee or committee policies elsewhere. 

The subcommittee expects to be involved in the humetn testing 
issue for some time to come. Today's hearing is just a step in that 
process. It does not focus on any particular legislation, which has 
not yet been written by this subcommittee. We expect to have more 
hearings before we consider whether to legislate in this area, and 
we will be working closely with the Clinton administration in fash- 
ioning an appropriate response. 

We appreciate the presence today of all of our witnesses and 
commend them for their preparation. We realize that with so many 
witnesses there will be limited time for making statements and an- 
swering questions today. However, additional materials and an- 
swers may be submitted at a later date. 

I am informed that I said 1960 through 1991 while referring to 
those experiments. As everyone knows, it was 1960 through 1971. 

I would like, before concluding my statement, to say a very pro- 
found thank you to Judge Webber for the use of his courtroom. I 
would also like to give thanks to Betsy Brockmeyer for all of her 
logistical development in making this possible. 

At this time, I recognize Congressman Mann. 

Mr. Mann. Thank you, Mr. Chairman. Welcome to Cincinnati. 
We are proud that you are here and I am proud to serve on your 
subcommittee. I enjoy very much working with you and I admire 
your leadership. 

I think this is an important hearing. As you know, I have been 
working on this subject for some months now, as this entire com- 
munity has been focused increasingly on the experiments that oc- 
curred between 1961 to 1971. I hope this hearing will cast new 
light and help focus the issue as this subcommittee takes up the 
question of compensation. 



I too would like to thank the witnesses who have agreed to tes- 
tify today. My heart goes out to all of the family members of the 
patients we will be discussing during this hearing. I know that re- 
living the illnesses of your loved ones some 20 years ago has 
brought you real pain. Three of you will sit at the witness table 
today. But I know many more of you would have liked to share 
your stories. 

I would like to ask unanimous consent, Mr. Chairman, that all 
the written statements submitted to the subcommittee, whether by 
witnesses or otherwise, be included in the record for today's pro- 
ceedings. 

Mr. Bryant. Without objection, so ordered. 

Mr. Mann. I would like to voice my appreciation for all witnesses 
other than family members who will be participating today, includ- 
ing Dr. Saenger. 

What we know to date, Mr. Chairman, is that some 87 patients 
received whole or partial body radiation. We know the patients in- 
volved were diagnosed with various forms of cancer believed to be 
terminal. 

We also know while they may have consented to the treatment, 
many or perhaps all of them were unaware of the Department of 
Defense interest in their conditions and many or perhaps all were 
unaware of the potential side effects of the radiation. 

We also know that written consent forms were not used until the 
mid-1960's. 

But let's get to the heart of the matter. We eJso know that the 
original University of Cincinnati proposal to the Pentagon, the con- 
tract between the University of Cincinnati and the Pentagon, and 
the first five reports about the project from the University of Cin- 
cinnati to the Pentagon all describe the purpose of the project in 
terms only of the Pentagon's needs, particularly its need for biologi- 
cal tests of radiation exposure, and not in terms of therapy for pa- 
tients. 

Each of the first five reports covering the period from February 
1960 to April 1967 label the project as "metabolic changes in hu- 
mans following total body irradiation." 

The term "therapeutic efforts" does not even become a part of the 
title of the reports to the Pentagon until 1968 when the title be- 
comes "Radiation Effects in Man: Manifestations and Therapeutic 
Efforts." 

It is also important to understand and keep focused on the fact 
that this project was conducted while the contract with the Penta- 
gon and while the Pentagon's money continued. Whole body radi- 
ation under this project neither preceded nor outlived the Penta- 
gon's contract. 

The two primary issues that I believe we need to resolve, Mr. 
Chairman, are, first, did the patients knowledgeably consent to the 
experiments? And by "knowledgeably," I mean were they fully in- 
formed of all the facts and circumstances and possible con- 
sequences to them and funding. 

And second, was this type of treatment appropriate for the types 
of illnesses suffered by the patients? By this I mean, absent the 
$8,000 or $10,000 per patient provided by the Department of De- 



fense, would whole body radiation have been an appropriate medi- 
cal therapy for these patients? 

If we find the answer to any of these questions is "no," then I 
believe we have no choice but to conclude that the radiation experi- 
ments were simply wrong and that the Government owes a huge 
apology to the victims, their families, and the Nation. 

Again, Mr. Chairman, I appreciate the hard work you and the 
staff have put into preparing for this hearing and I look forward 
to the testimony here today. Thank you very much. 

[The opening statements of Messrs. Bryant and Mann follow:] 



OPENING REMARKS 

REP. JOHN BRYANT, CHAIRMAN 

SUBCOMMITTEE ON ADMINISTRATIVE LAW 
AND GOVERNMENTAL RELATIONS 

HEARING ON RADIATION EXPERIMENTS CONDUCTED BY THE 

UNIVERSITY OF CINCINNATI MEDICAL SCHOOL WITH 

DEPARTMENT OF DEFENSE FUNDING 

GOOD MORNING LADIES AND GENTLEMEN AND 
DISTINGUISHED GUESTS. THE SUBCOMMITTEE WILL COME TO 
ORDER. THE HOUSE JUDICIARY COMMITTEE'S SUBCOMMITTEE 
ON ADMINISTRATIVE LAW AND GOVERNMENTAL RELATIONS 
MEETS TODAY IN CINCINNATI TO TAKE TESTIMONY 
CONCERNING THE WHOLE AND PARTIAL BODY RADIATION 
EXPERIMENTS CONDUCTED AT CINCINNATI GENERAL HOSPITAL 
AND THE UNIVERSITY OF CINCINNATI MEDICAL CENTER 
BETWEEN 1960 AND 1971 AND PARTIALLY FUNDED BY THE 
DEPARTMENT OF DEFENSE. 

THIS SUBCOMMITTEE HAS JURISDICTION OVER 
COMPENSATION FOR CUIMS AGAINST THE FEDERAL 
GOVERNMENT BASED ON THE FEDERAL GOVERNMENT'S 



2 
WRONGDOING, AND CONSIDERED PREVIOUS COMPENSATION 

LEGISLATION, SUCH AS THE CIVIL LIBERTIES ACT OF 

1988, WHICH COMPENSATES JAPANESE-AMlERICANS WHO WERE 

IN INTERNMENT CAMPS DURING WORLD WAR II, AND THE 

RADIATION EXPOSURE COMPENSATION ACT OF 1990, WHICH 

COMPENSATES THE RESIDENTS WHO LIVED DOWNWIND FROM 

THE NEVADA NUCLEAR TEST SITE AND THE WORKERS WHO 

PARTICIPATED IN THOSE TESTS OR MINED URANIUM FOR THE 

GOVERNMENT. 

ON FEBRUARY 2, 1994, THE SUBCOMMITTEE HELD A 
HEARING EXAMINING THE ISSUE OF GOVERNMENT-SPONSORED 
EXPERIMENTS PERFORMED ON HUMANS WHO DID NOT GIVE 
INFORMED CONSENT TO THE EXPERIMENTS -- INCLUDING 
SEPARATE TESTS INVOLVING RADIATION, MUSTARD GAS, LSD 
AND OTHER CHEMICAL AGENTS. 

THE ALLEGATIONS REGARDING THE CINCINNATI 
RADIATION EXPERIMENTS ARE VERY SERIOUS. IF THEY ARE 



3 

TRUE, THESE HUMAN EXPERIMENTS COULD BE AMONG THE 

MOST EGREGIOUS THAT HAVE BEEN BROUGHT TO LIGHT YET. 

OUR TASK IS TO EXAMINE THESE TESTS, WHETHER THE 
SUBJECTS GAVE INFORMED CONSENT TO PARTICIPATING IN 
SUCH TESTS, WHAT HARM RESULTED FROM THE TESTS, AND 
WHETHER COMPENSATION IS APPROPRIATE. 

I WOULD LIKE TO THANK CONGRESSMAN DAVID MANN, A 
MEMBER OF THIS SUBCOMMITTEE, FOR BRINGING THE 
CINCINNATI RADIATION EXPERIMENTS TO THE 
SUBCOMMITTEE'S AHENTION. I COMMEND CONGRESSMAN 
MANN'S COMMITMENT AND PERSISTENCE IN BRINGING THE 
ISSUE OF THESE EXPERIMENTS TO THE FOREFRONT IN THE 
CONGRESS AND THE ADMINISTRATION. I KNOW HE ALSO IS 
WORKING CLOSELY WITH THE HUMAN RADIATION INTERAGENCY 
WORKING GROUP ESTABLISHED BY PRESIDENT CLINTON TO 
ASSURE THAT THESE EXPERIMENTS GET SERIOUS 
EXAMINATION AS PART OF THAT GROUP'S CONSIDERATION. 



8 

4 

THE SUBCOMMITTEE ALSO WOULD LIKE TO WELCOME 

CONGRESSMAN ROB PORTMAN TO THIS SUBCOMMITTEE 
HEARING. WHILE CONGRESSMAN PORTMAN IS NOT A MEMBER 
OF THE JUDICIARY COMMITTEE OR THIS SUBCOMMITTEE, AND 
THE JUDICIARY COMMITTEE'S POLICY DOES NOT ALLOW NON- 
MEMBERS TO QUESTION WITNESSES AT COMMITTEE HEARINGS, 
I THINK IT IS APPROPRIATE IN THIS INSTANCE FOR 
CONGRESSMAN PORTMAN TO SIT WITH THE SUBCOMMITTEE, 
BASED ON HIS EXTENSIVE INVOLVEMENT WITH THIS ISSUE. 
I THINK CONGRESSMAN PORTMAN'S INVOLVEMENT IN THIS 
HEARING IS AN UNUSUAL CASE, AND I DO NOT INTEND FOR 
HIS INVOLVEMENT TO BE A PRECEDENT FOR FUTURE 
SUBCOMMITTEE OR COMMITTEE HEARINGS. 

THE SUBCOMMIHEE EXPECTS TO BE INVOLVED IN THE 
HUMAN TESTING ISSUE FOR SOME TIME TO COME. TODAY'S 
HEARING IS JUST A STEP IN THE PROCESS, AND DOES NOT 
FOCUS ON ANY PARTICULAR LEGISLATION. WE EXPECT TO 
HAVE MORE HEARINGS BEFORE WE CONSIDER WHETHER TO 



5 
LEGISLATE IN THIS AREA. AND WILL BE WORKING CLOSELY 

WITH THE CLINTON ADMINISTRATION IN FASHIONING AN 

APPROPRIATE RESPONSE. 

WE APPRECIATE THE PRESENCE TODAY OF ALL OUR 
WITNESSES AND COMMEND THEM FOR THEIR PREPARATION. 
WE REALIZE THAT WITH SO MANY WITNESSES THERE WILL BE 
LIMITED TIME FOR MAKING YOUR STATEMENTS AND 
ANSWERING QUESTIONS TODAY. HOWEVER. ADDITIONAL 
MATERIALS AND ANSWERS MAY BE SUBMITTED AT A LATER 
DATE. 

I NOW RECOGNIZE CONGRESSMAN DAVID MANN TO MAKE 
AN OPENING STATEMENT. 



CONGRESSMAN PORTMAN, WOULD YOU LIKE TO MAKE AN 
OPENING STATEMENT? 



10 




NEWS from 

Congressman David Mann 



First District — Ohio 



The Statement of 

The Honorable David Hann 

April 11, 1994 

Mr. Chairman, I would like to thank you for agreeing to convene this 
hearing today. As you know, I have been working very hard to uncover 
the facts with regard to the radiation tests performed at Cincinnati 
General Hospital in the 1960s and 1970s and I believe that this hearing 
will help to uncover evidence previously unknown and put some logical 
order to the information already available to us. 

I would like to thank the witnesses who have agreed to testify 
before us today. My heart goes out to all of the family members of the 
patients we will discuss during this hearing. I know that reliving 
the illnesses of your loved-ones some twenty years ago has brought you 
real pain. Three of you will sit at the witness tcible today, but I 
know many more of you would have liked to share your stories. I would 
like to ask for unanimous consent that all of the written statements 
submitted to the Subcommittee and our offices be included in the record 
for today's proceedings. 

I would also like to recognize and voice my appreciation for 
witnesses who will present their candid views of the radiation studies. 
Dr. Egilman, Dr. Stephens, and Dr. Cox. I would like to thank Dr. 
Soper from the Department of Defense for presenting testimony on the 
DOD record retrieval process and President Steger for his testimony on 
the University's efforts to help investigate this matter. And I would 
like to thank Dr. Saenger for his willingness to present his views on 
the radiation experiments and to answer the many questions this 
Subcommittee will pose. 

What we know to date, Mr. Chairman, is that some 87 patients 
received whole and partial body radiation in experiments funded in, part 
by the Department of Defense. We know that the patients involved 'were 
diagnosed with various forms of cancer believed to be terminal. "We 
also know that while they may have consented to the treatment, many or 
perhaps all of them were unaware of the Department of Defense interest 
in their conditions and many or perhaps all were unaware of the 
potential side effects of the radiation. We also know that written 
consent forms were not used until the mid 1960s. 

(over) 



WASHINGTON OFFICE DISTRICT OFFICE 

503 Cannon HOB. 2210 Kroger Building 

Washington, DC. 20515 •Ol'* Vine Street 

(202) 225-2216 Cincinnati, OH 45202 

_ (513) 684-2723 



11 



But lets get to the heart of the matter. We also know that the 
orginial University of Cincinnati proposal to the Pentagon, the 
contract between U.C. and the Pentagon and the first five reports about 
the project from U.C. to the Pentagon all describe the purpose of the 
project in terms of the Pentagon's needs -- particularly its need for a 
biological test of radiation exposure -- and not in terms of therapy 
for patients. Each of the first five reports (covering the period from 
February 1960 to April 19G7) labeled the project as "Metabolic Changes 
in Humans Following Total Body Irradiation". "Theraputic Efforts" do 
not even become a part of the title of the reports to the Pentagon 
until 1968 when the title becomes "Radiation Effects in Man: 
Manifestations and Theraputic Efforts." 

Note also that this project was conducted while the contract with 
the Pentagon and the Pentagon's money continued. Whole body radiation 
under this project neither preceeded nor outlived the Pentagon 
contract . 

The two primary issues that I believe we need to resolve, Mr. 
Chairman, are (1) Did the patients knowledgeably consent to the 
experiments? And, (2) Was this type of treatment appropriate for the 
types of illnesses suffered by the patients. By this I mean, absent 
the $8,000 - $10,000 per patient in Department of Defense funding, 
would whole body radiation have been an appropriate medical therapy? 

If we find that the answer to either of these questions is "no" then 
I believe we have no choice but to conclude that the radiation 
experiments were SIMPLY WRONG and that the government owes a huge 
apology to the victims, their families and the nation as a whole! 

Again, Mr. Chairman, I appreciate the hard work you and your staff 
have put into preparing for this hearing. I believe that the testimony 
we hear today will enable us to craft a fair and just compensation bill 
in the weeks and months ahead. Thank you. 



12 

Mr. Bryant. Mr. Portman. 

Mr. Portman. Mr. Chairman, thank you for coming to Cincinnati 
to hold this important hearing and also for including me as a pan- 
elist. As you noted, I am not a member of the subcommittee; how- 
ever, I do have a long commitment to this issue. I have been heav- 
ily involved in the issue for the past several months, and also the 
issues impact the people who live in my district. In particular, 
some of the patients involved lived in what is now the Second Dis- 
trict of Ohio. Many of the family members, including at least one 
who will be testifying here today, currently live in the district I 
represent. 

This matter has a long but unfortunately incomplete history of 
public scrutiny. There remain unanswered questions that relate not 
only to the critical aspect of how people and their families were 
treated, but also the role of the Federal Government in conducting 
such experiments on human beings. 

Although there are many issues that will be addressed by the 
various parties involved, in my mind, there are two cardinal issues 
that we, as Federal officials, can and must address. The first is the 
appropriateness of the Federal Government compensating the vic- 
tims and their families. If it is determined that the patients in- 
volved were not clearly informed in accordance with the standards 
for informed consent in force at the respective times of the experi- 
ments, or that these experiments became vehicles primarily for 
testing, not treatment, then compensation, in my view, would be 
appropriate. 

This is so especially in light of the many potential legal barriers 
to recovery, including the statute of limitations under the Federal 
Tort Claims Act, sovereign immunity, and possible immunity of 
Government contractors. 

Chairman Bryant's subcommittee has jurisdiction over the com- 
pensation issue, and I understand that there is some precedent for 
compensation when the facts so merit it. Because I am not on the 
subcommittee or committee, I will not have the opportunity to vote 
upon this issue at the committee level. 

I believe that the second issue from the Federal Government's 
standpoint is one of disclosure — disclosure by the Department of 
Defense and the Cincinnati General Hospital and all others in- 
volved — of all relevant information concerning these cases. 

In addition to reviewing the merit of compensating potential vic- 
tims, I believe the Grovemment and the Government contractors 
have an obligation to be fully forthcoming, to admit mistakes if 
mistakes have been made, sind to ensure that safeguards are put 
in place with respect to any experiments that may be conducted 
today or in the future. 

The issues of fiill disclosure and safeguards may not be directly 
related to this forum. However, I have particular interest in these 
issues, and the Grovemment Operations Committee upon which I 
serve has been exploring the possibility of having additional hear- 
ings on those two issues. 

Finally, I am here to listen and to continue to learn as much as 
I can about what happened two £ind three decades ago. This is not 
a court of law; we are not here to press charges. We are also not 
here to politicize what is a sensitive and emotional topic. 



13 

I view our role as factfinders who want to ensure that the Fed- 
eral Government acts responsibly and fairly with respect to the pa- 
tients and their families, to the investigators and to the DOI) offi- 
cials involved in the study. 

I commend all of the witnesses for being here today. I commend 
you for agreeing to testify and very much look forward to your tes- 
timony. 

Thank you, Mr. Chairman. 

[The prepared statement of Mr. Portman follows:] 



14 



STATEMENT OF HONORABLE ROB PORTMAN 
SUBCOMMITTEE ON ADMINISTRATIVE LAW AND GOVERNMENTAL RELATIONS 

APRIL 11, 1994 



Mr. Chairman, first, let me thank you for coming to 
Cincinnati to hold this important hearing and for including me as 
a panelist. Although I am not a member of the Subcommittee, the 
issues addressed here impact many people who live in the District 
I represent. In particular, some of the patients involved lived 
in what is now the Second District and many of the family members 
- including some we will be hearing from today - are my 
constituents. 

This matter has a long, but unfortunately incomplete, 
history of public scrutiny. There remain unanswered questions 
that relate to not only the critical aspect of how people and 
their families were treated, but also the role of the federal 
government in supporting such experiments on human beings. 

Although there are many issues that will be addressed by the 
various parties involved, in my mind, there are two cardinal 
issues that we as federal officials can and must address. 



15 



The first is the appropriateness of the federal government 
compensating the victims and their families. If it is determined 
that the patients involved were not clearly informed in 
accordance with the standards for informed consent in force at 
the respective times of the experiments, or that these 
experiments became vehicles primarily for testing not treatment, 
then compensation, in my view, would be appropriate. This is so 
especially in light of the many potential legal barriers to 
recovery, including the statute of limitations under the Federal 
Tort Claims Act, sovereign immunity, and possible immunity of 
government contractors. Chairman Bryant's subcommittee has 
jurisdiction over the compensation issue, and I understand that 
there is some precedent for compensation when the facts so merit 
it. Because I am not on the subcommittee or committee, I will 
not have the opportunity to vote upon this issue at the Committee 
level. However, I would have the chance to consider any proposal 
for compensation on the Floor of the House of Representatives. 

I believe the second issue from the federal government's 
standpoint is one of disclosure — disclosure by the Department 
of Defense and the Cincinnati General Hospital and all others 
involved — of all relevant information concerning these cases. 
In addition to reviewing the merit of compensating potential 
victims, I believe the government and the government contractors 



16 



3 

have an obligation to be fully forthcoming, to admit mistakes if 
mistakes have been made, and to ensure that safeguards are put in 
place with respect to any experiments that may be conducted today 
or in the future. The issues of full disclosure and safeguards 
may not be directly related to this forum. However, I have 
particular interest in these issues, and the Government 
Operations Committee upon which I serve has been exploring the 
facts of the UC cases and the possibility of holding hearings on 
disclosure of government information and safeguards. 

Finally, I am here to listen - and to continue to learn as 
much as I can about v/hat happened 2 and 3 decades ago. This is 
not a court of law; we are not here to press charges. We also 
are not here to politicize a sensitive and emotional topic. I 
view our role as fact finders who want to ensure that the federal 
government acts responsibly and fairly with respect to the 
patients and their families, to the investigators and to the DOD 
officials involved in the study. 

I commend all of the witnesses who have agreed to testify 
before us today and very much look forward to their testimony. 
Thank you Mr. Chairman. 



17 

Mr. Bryant. At this time we would invite to come to the witness 
table the first three witnesses on our panel. 

First, Joseph Larkins, survivor son; Gloria Nelson, survivor 
granddaughter; and Katherine Hager, survivor daughter. 

We would ask that each of you, as well as £dl of the witnesses 
who come behind you, limit your statement to 5 minutes in order 
that we might ask you questions and have time for all the wit- 
nesses to speak. 

I will begin on my left; with Mr. Larkins. Mr. Larkins, thank you 
very much for coming here today. Please proceed. 

STATEMENT OF JOSEPH LARKINS, SURVIVOR SON 

Mr. Larkins. All right. Well, my name is Joe Larkins. I am 52 
years old now. My father, Willard Larkins, passed away in 1971. 
At that time, I was 30. My family consisted of myself, an older sis- 
ter, and my parents. When my father passed away he and my 
mother were in the process of raising a grandchild, my sister's son. 
Neither of my parents were well educated, but my father was hard 
working and honest. If Cincinnati Cleneral Hospital and the doctors 
therein had been honest, there is, of course, the possibility that my 
father could have lived for several more years. Instead, he went 
from a fairly able-bodied, middle-aged father, and husband to a 
premature death caused by an experiment. My father did not know 
that he was being used as a guinea pig; my mother did not know; 
as his children, we were not informed of the procedures to be used 
or of the risks involved. 

I feel as though Dr. Saenger and the other doctors involved, if 
you will, knew that the high levels of radiation which they admin- 
istered to these patients had the very real probability of being 
fatal. Oh, how right that is! My father was very much a family 
man, yet these people killed him as surely as if they had put a gun 
to his head and pulled the trigger themselves. These doctors left 
my mother, with no job skills, to raise a grandchild as best as she 
could. My mother lived until 1983, but she was a broken woman 
after my father's premature and unexpected death. 

I know that my father knew that something was very wrong with 
the treatments being given to him at Cincinnati General. He even 
asked me, "Son, what are they doing to me? They're trying to kill 
me." That is how bad the pain he endured after the treatment was. 
He suffered so needlessly. 

What really gets me about this situation is the fact that the Pen- 
tagon contracted with these doctors and this hospital to test the ef- 
fects of radiation on the human body. Everyone realizes that Cin- 
cinnati General Hospital, now the University of Cincinnati Hos- 
pital, treated many low-education, low-income patients. I guess 
they felt that in some way the fact that these patients were not 
rich, upper class citizens gave them the right to experiment with 
their bodies without informed consent. Not so. I feel sure these 
physician-researchers were well paid for their part, and it would be 
very interesting to know the types and dollar amounts of the 
grants given to Cincinnati Greneral by the Federal Government. I 
feel sure that all parties, with the exception of the poor, 
unsuspecting patients and their families, were well compensated. 



18 

But since when, in our society, does one man or even a group of 
them, have the right to play God? 

A very good example of this is our 20th century "assisted-suicide 
doctor." This man is contacted by terminally ill patients who wish 
to end their own lives with dignity and choose, by their own voli- 
tion, not to suffer needlessly for years. These people make the deci- 
sion to die in peace, yet our great judicial system, along with the 
medical community, brought this compassionate physician up on 
charges. 

The differences in these deaths and the death of my father are 
that my father did not choose to die — someone else made that deci- 
sion for him without consulting or informing him, and they were 
amply compensated for it. 

I feel that the price they should be required to pay to the fami- 
lies of the people they killed should be exceedingly high. I also feel 
that the Federal Government should be named as a coconspirator 
in this case, because that is exactly what it was, a conspiracy. 

No person — and I emphasize "no" person — would willingly con- 
sent to a treatment with any degree of fatality involved. People, 
both you and I, simply value life too much. I think that is the big 
thing here, the patients were not informed. I know that behavior 
of this sort would not be tolerated by the medical community today. 

But then again, this entire mess was surrounded by a thick veil 
of secrecy on both the doctors' part and on the part of Cincinnati 
General Hospital. It is still being closely guarded and kept under 
yet another veil of secrecy to this very day by the University of 
Cincinnati, in that they have yet to provide the medical records of 
the patients involved in this experiment — ^but they have, as of now. 
At the time of this statement they were not — in the entirety, to the 
next of kin immediately. 

They are hedging to save their own skin. I was promised my fa- 
ther's complete medical file over a month ago; as of this writing, 
I have nothing. But like I said, we do have them now. 

I only hope that you, the congressional committee, see fit, as 
members of the human race, to break this matter wide open here 
and now and award just compensation to the families of the vic- 
tims. I feel that the physicians involved and also the Federal Gov- 
ernment, the Pentagon, should pay; and also I beg you to strip any 
and all of the doctors involved of all their medical credentials that 
they hold. If justice prevails in this matter — and I have faith that 
it will — a strong message will be sent to our government officials 
and the private physicians, to whom people entrust their lives and 
the lives of their loved ones, that behavior of this sort will simply 
not be tolerated, that justice will, in fact, be both swift and severe. 
I pray that a situation such as this will never again be faced by 
a group of people. If this statement to you, the congressional com- 
mittee, does anything to help in the name of justice, then my fa- 
ther's death and the sorrow and hardships that his family faced, 
will not have been completely in vain. 
Thank you. 

Mr. Bryant. Thank you, Mr. Larkins. 
Ms. Nelson. 



19 

STATEMENT OF GLORIA NELSON, SURVIVOR 
GRANDDAUGHTER 

Ms. Nelson. Amelia Jackson, patient number 67. 

On October 21, 1966, after being discharged from General Hos- 
pital, Ms. Jackson was a very wesik, ill woman. She was unable to 
take care of herself properly £ind depended on the family for all of 
her basic needs. She experienced bleeding from her rectum, loss of 
appetite, nausea, vomiting, weight loss, and was in constant pain. 
Her condition never improved. 

Within a few weeks, she was readmitted to Greneral Hospital. 
The family was informed she should be transferred to Drake Hos- 
pital. Ms. Jackson indicated she was afrgiid and want to return 
home. She was transported home, where she was loved and cared 
for by us until she died on March 25, 1967. 

The family of Amelia Jackson would like for this committee to 
know that for the entire 163 days after receiving the irradiation, 
her condition continued to deteriorate. We feel that the 100 rads 
of partial-body irradiation administered to her was cruel, and 
didn't help her condition in any way. It is our belief that she may 
have lived longer if this experiment had not taken place. 

A doctor is someone you trust. His job is to do ever3rthing in his 
power to alleviate your pain and suffering. However, this was not 
the case. She was always crsdng, moaning, groaning, and in excru- 
ciating pain. Ms. Jackson was used to further Dr. Saenger's profes- 
sional goals. It was purely an ambitious and callous act. Neither 
Ms. Jackson nor the family was informed or consented to her being 
used in an experiment conducted by Dr. Saenger, and funded by 
the Department of Defense. There has clearly been a coverup by 
means of the Government, General Hospital, Dr. Saenger, and the 
city of Cincinnati. We cannot believe that they consented to such 
atrocities to be financed by the Government utilizing the Jacksons' 
and the family's taxpaying dollars. 

Mr. Bryant. Thank you, Ms. Nelson. 

Ms. Hager. 

STATEMENT OF CATHERINE HAGER, SURVIVOR DAUGHTER 

Ms. Hager. To the total body radiation subcommittee and whom 
it may concern: 

In January 1994, I began noticing articles in The Cincinnati 
Enquirer regarding total body radiation experimentation done on 
cancer patients in the 1960's at Cincinnati General Hospital. Since 
I knew my father, Joseph Mitchell, was treated at that hospital for 
cancer during that period of time, I contacted Linda Reeves at the 
Cincinnati Enquirer. After a brief discussion with Linda, it was de- 
termined that my father had indeed been involved in the total radi- 
ation experimentation as patient No. 51, the first patient to be 
identified. From this point, my husband and I, along with the as- 
sistance of the news media, attempted to piece together any records 
available regarding my father's treatment at the hospital. 

In October 1963, my father was diagnosed with lung cancer in 
the right lung, and was admitted to Cincinnati General Hospital. 
Surgery was scheduled for November 1963. Although there is no 
notation of this scheduled surgery in his medical records, we have 
a letter which was written by my father to my sister detailing the 



20 

planned operation. For some unknown reason, the surgery was can- 
celed on the day it was scheduled to take place, with no expla- 
nation. The surgery was never rescheduled. Instead, my father was 
given a schedule of dates to return to the hospital for cobalt treat- 
ments. At this point, I asked the doctor why the surgery was can- 
celed. He told me he was too weak for surgery and decided to opt 
for the cobalt treatments instead. 

In reality, my father was not in a weakened state at that time, 
but was in relatively good health, still working, and living a normsd 
life. It wasn't until the cobalt treatments started that my father 
began to go downhill. After 35 days of treatments, my father was 
so weak that he had to retire from work and move closer to my 
family so we could help care for him. 

In early 1965, my father was again admitted to Cincinnati Gen- 
eral Hospital with severe chest pains. It was at this time he was 
subjected to the total body radiation, 150 rads. He immediately 
started on a drastic downhill spiral. After much suffering, my fa- 
ther died on July 14, 1965, 74 days after the total body radiation. 

Since total body radiation had not been performed on cancer pa- 
tients at Cincinnati General Hospital prior to the Grovemment 
funding of 1960, I feel that my father, along with other cancer pa- 
tients, were handpicked and used in total body radiation, not as a 
treatment for cancer, as they had been told, but as a coverup for 
a study performed for the Department of Defense to determine pos- 
sible effects on soldiers in nuclear warfare. 

It might be noted that at the time my father died, two of my 
brothers were in the U.S. Air Force, one in Vietnam in the war 
zone. The Red Cross had to locate him and bring him home for the 
funeral. Both brothers have since retired from the Air Force. Isn't 
it ironic that two of my brothers were serving this country in the 
military, while at the same time the Government was sponsoring 
experiments which shortened or ended their father's life? 

I would like to read the little note that my father sent to my sis- 
ter, which was written November 2, 1963. 

Dear Isabell: I am very sorry, honey; I need your help. First, I am going to have 
an operation, first part of the week. The doctor is not giving out the right news to 
the family. It is going to be a long, serious operation. I will be about two months 
here, and it is very serious. Only a 50/50 chance to come through, as all I have left 
is half a lung. So therefore I ask you to do all you can to help mom as much as 
possible, while I am in here. 

I can tell you more when I see you again, but please do not take it to heart. I 
am trusting everything will turn out okay, which is doubtful. See you soon. 
Love, 

Dad. 

Thank you very much. 

Mr. Bryant. Thank you, Ms. Hager. 

Mr. Larkins, let me start with you by asking, when did you or 
your representative request your relative's records from the Uni- 
versity of Cincinnati? 

Mr. Larkins. A little over a month ago. 

Mr. Bryant. Have you received them yet? 

Mr. Larkins. Yes, I finally got them today. 

Mr. Bryant. Did you make the same request, Ms. Nelson? 

Ms. Nelson. Yes. 

Mr. Bryant. And have you received them also? 



21 

Ms. Nelson. Yes, I received them Friday. 

Mr. Bryant. How long ago did you make the request? 

Ms. Nelson. Over a month ago. 

Mr. Bryant. A month ago. 

Ms. Hager, did you request the records? 

Ms. Hager. Yes, I did. But I don't think we have all of them. We 
got some, but I still think there are more there. 

Ms. Nelson. Same here. 

Ms. KLager. You feel so, too? 

Ms. Nelson. Yes. They are not all there. 

Mr. Bryant. When did you get yours, Ms. Hager? 

Ms. Hager. When did we receive ours, Bob? 

Mr. Bob Hager. Approximately 3 weeks ago. 

Mr. Bryant. Sir, would you identify yourself? 

Mr. Bob Hager. I am Mr. Hager, Catherine's husband. 

Mr, Larkins. Can I say something else? 

Mr. Bryant. Yes, Mr. Larkins. 

Mr. Larkins. When we were going through my dad's files, we 
found charts from 1971, December. He died in June of 1971. I 
would like to know how that can be. 

Mr. Bryant. Did you find anything else unusual? 

Mr. Larkins. The signatures on half of the papers are not his. 
A couple of them are, but not all of them. 

Ms. Nelson. The signatures on my grandmother's papers, they 
are not hers either. 

Mr. Bryant. You say they are not? 

Ms. Nelson. No. 

Mr. Bryant. Does it purport to be her signature, but it is not her 
writing? 

Ms. Nelson. Right. And also I found documents in my grand- 
mother's records that were originally made out for someone else. 
That person's name is scratched out. Her name put in and a dif- 
ferent number put in. 

Mr. Bryant. Can you tell us, Mr. Hager, what type of harm your 
relatives suffered from the radiation treatment that was not a nor- 
mal result of cancer treatment? 

Mr. Larkins — I am sorry; I spoke the wrong name — what type of 
harm did your father suffer from radiation treatment that was not 
a normal result of cancer treatment? 

Mr. Larkins. Well, I guess the fact— just the way he went down- 
hill. He was hoping to get well, but he was telling me, deep down, 
I guess that he knew, like I said, that something was wrong. He 
didn't know what. He wasn't getting no better. He was getting 
worse. 

Mr. Bryant. I should say obviously we don't expect you to know 
what is the normal result of cancer, since you are not a doctor. But 
in terms of a la)nnan's observation. Mrs. Nelson. 

Ms. Nelson. My grandmother lost over 30 pounds after she had 
her radiation treatments, within a 3-month period. 

Mr. Bryant. Ms. Hager. 

Ms. Hager. My father was burnt pretty bad after he had his 
total body radiation. He had it on May 1. I think he came home — 
he had it on May 1. He came home on May 8, 1965, he came home, 
and we had to take care of him. He was bedridden. We had to give 



22 

him baths. The Red Cross had to come and take him back and 
forth to the hospital every day. A nurse came every day and took 
a blood test from his finger. 

I meEin, he was just — he couldn't eat. He couldn't sit up. He had 
to — whatever came out of him, whatever kind of spittle came out 
of him, we used to have to save that and take it back to the hos- 
pital. 

Mr. Bryant. OK. Let me ask you a question. 

You spoke in your testimony about the fact that your father's 
surgery was called off, and instead he was given cobalt treatments. 
After 35 days 

Ms. Hager. He had 35 days of cobalt treatment plus the whole 
body radiation also. 

Mr. Bryant. But the whole body radiation took place about 2 
years later; is that correct? 

Ms. Hager. That is correct. 

Mr. Bryant. And the letter from your father was dated 1963, im- 
plying that you 

Ms. Hager. That was the first surgery he was supposed to have, 
that they did not give him. They had him prepared for surgery that 
day, and the nurse come in the same day and said — ^they started 
taking the things off of him. 

I said, what are you doing? And she said, they canceled the sur- 
gery. He is not going to have surgery today. 

And I said, well, who do we talk to to find out what is going on? 
And she said, you will have to get a hold of his doctor. 

We sat there all day and no doctor came into the room to talk 
to us to explain £inything. 

Mr. Bryant. Mr. Mann. 

Mr. Mann. I want to thgink each of you for taking the time to 
be with us. I know that it is not easy going over a sad chapter in 
your life. And it is of immense value to us. 

Mr. Larkins, were you or any member of your family ever 
present when the radiation treatment, the radiation experiments 
were discussed with your father by any of the doctors at the hos- 
pital? 

Mr. Larkins. No, sir; I wasn't. 

Mr. Mann. Did he ever talk with you about the radiation that 
he was going to have administered to him? 

Mr. Larkins. He didn't talk to me about it, but he talked to me 
after. I was out there a couple of times after his treatments. That 
is the one time he asked me what they were trjdng to do with him. 
He received 300 rads of the radiation. I understand he got the most 
of anybody. 

Mr. Mann. Do you know why he asked the question that way, 
what are they trying to do to me? 

Mr. Larkins. I think he was scared that he was dying from it. 

Mr. Mann. Was he suffering in a particular way at that point 
that led him to make that comment? 

Mr. Larkins. To me, he was suffering all over. I mean, he was 
just hurting all over. He didn't know what to think about what was 
going on. He wanted to get well, but I guess that is what he had 
in the back of his mind, was that eventually he would get well, but 
he didn't. He was only 55 years old, 3 years older than I am now. 



23 

Mr. Mann. Ms. Nelson, your grandmother, how old were you 
when she died? 

Ms. Nelson. I was 20. 

Mr. Mann. Were you or any other family members present when 
the proposed treatment was discussed with her? 

Ms. Nelson. No. We didn't even know that she had the treat- 
ment until I had read that in the Enquirer, and we pieced to- 
gether — and the date of her death, and the condition of her cancer 
and all that. That is when we found out that this was my grand- 
mother. All they had was H.A. 

Mr. Mann. So there was no discussion that they had with any 
member of the family, that you are aware? 

Ms. Nelson. No. 

Mr. Mann. Did she ever say an3^hing about the radiation? 

Ms. Nelson. She never said anjrthing about the radiation nor did 
she say anything about the three cobalt treatments she received, 
that I found in her records. 

Mr. Mann. Basically, she was doing what the doctors rec- 
ommended to her? 

Ms. Nelson. Right. She didn't know any better. 

Mr. Mann. Ms. Hager, your father, in his treatment, did you or 
any member of the family — ^were you present when the doctors 
were explaining what they were proposing? 

Ms. Hager. No. The d.octors never told us anything. The only 
thing the doctor told me was when I went out there, when they 
canceled the surgery, I made an appointment to go out there and 
talk to the doctor, and all he told me was that they wanted to build 
him up and make him a Uttle stronger. He was only 5-foot-2 and 
weighed 116 pounds. He was doing this normal work every day, 
and I mean, you know, you listen to what the doctor says and you 
don't question it. 

So I figured, well, maybe they want to fatten him up a little bit 
more than 116 pounds to do the surgery they wanted to do; £ind 
he said, we are going to go with the cobalt treatment, and we are 
going to let it go at that for now. 

And that is the only — ^that is the only time I met with the doctor 
on any of this. And I used to go with him when he would go get 
his treatments; I was there every time with him. They would t^e 
him away from me; I would sit in the hall, and then they would 
come out and say, well, your dad is a little sick for a while; we are 
going to hold him for a little bit, then we can release him and come 
home. 

Him and I rode the bus together. But they never let you go back 
and see what they did; they made you sit in the hall and wait. 

Mr. Mann. Did he ever express concern to you about what was 
happening to him or wondered whether 

Ms. Hager. No. He trusted the doctor. He trusted the doctor. 
Whatever the doctor said, that is what he did, because he thought 
the doctor was going to make him better. 

Mr. Mann. Which doctors do you have contact with? Do you re- 
member the names? 

Ms. Hager. Sir, I wish I could remember. I asked for the doctors 
in charge. Whoever they gave me, I have no idea. 

Mr. Mann. Did you ever meet Dr. Saenger? 



24 

Ms. Hager. Sir, I couldn't tell you. I don't know if I did or not. 

Mr. Mann. Dr. Silberstein. 

Ms. Hager. Like I said, I couldn't tell you. 

Mr. Mann. Dr. Aron. 

Ms. Hager. I have no idea. 

Mr. Mann. Dr. Horowitz. 

Ms. Hager. I have no idea. I met one doctor at one time. I don't 
know who it was. 

Mr. Mann. Mr. Larkins, do you remember meeting any of those 
doctors, the names I just gave? 

Mr. Larkins. No. I think I remember seeing Dr. Saenger, but I 
never met him. The only people I talked to was like nurses and or- 
derlies, sometimes. 

Mr. Mann. Where did you see Dr. Saenger? 

Mr. Larkins. In the tunnels and General Hospital. 

Mr. Mann. Did you talk to him? 

Mr. Larkins. No. He was pointed out to me by someone else. 

Mr. Mann. Pointed out to you as what? 

Mr. Larkins. As the doctor in charge. 

Mr. Mann. Ms. Nelson, do you recil meeting any of the doctors? 

Ms. Nelson. Never saw any of the doctors, never talked to them. 
Whenever I went with my grandmother to the hospital, there were 
just the nurses around. 

Mr. Mann. Thank you, Mr. Chairman. 

Mr. Bryant. Mr. Portman. 

Mr. Portman. Thank you, Mr. Chairman. 

Thank you all for being here today. It takes a lot of courage to 
do what you are doing. It is difficult, I know, to talk about it. I just 
have a few questions. 

Mr. Larkins, first, my question to you is really whether you know 
whether your father knew anything about the military study that 
was going on. Did he ever talk about that? 

Mr. lSikins. He never knew anything about that. Me and my 
dad were pretty close, and I think he would have talked to me 
about it. He probably would have said, hey, man, they have got the 
Government on us, and they are really going to do some good ac- 
tion. They really did. 

Mr. Portman. How did you and your mother first learn about 
the military aspect of the study? 

Mr. Larkins. In the paper, when it first started to come out this 
year. 

Mr. Portman. This year? 

Mr. Larkins. Yes. 

Mr. Portman. On the consent side, did your father ever talk 
about the various options he had before him? Do you know if he 
was apprised of the risks and benefits 

Mr. Larkins. The only thing he ever told me was, "they have got 
their treatment schedule for me; they have got another treatment 
schedule for me." That is all he would say. 

Mr. Portman. So in terms of whether he consented to the treat- 
ment in an informed way, do you know whether he was told what 
the risks and benefits of the treatment were? 

Mr. Larkins. I don't think he was. He was kind of like me, or 
I guess I am like him. I want to know what is facing me. He would 



25 

have told me, Joe, I have got chances of dying. We would have 
talked about it. He didn't say nothing like that. 

He said, they have got another treatment scheduled for me. They 
are going to use me again. That is one time he said that, "They are 
going to use me again." What he meant at that time, I didn't know. 

Mr. PORTMAN. At the end of your testimony you talked about the 
compensation issue. I just wondered if you could give us a sense 
of what you might think just compensation would be in this case. 

Mr. Larkins. Bring him back, but I know that is not possible. 

I have no idea, but I think it should be something just. I have 
no idea what to say. 

Mr. PoRTMAN. Thank you again for being here and for your 
statement. 

Ms. Nelson, your grandmother, Mrs. Jackson, went through a 
tough time. You gave us a lot of good information. 

Just in terms of getting the dates straight, you mentioned she 
was discharged in 1966. When did she first become involved in the 
radiation experiments; do you know? 

Ms. Nelson. In October 1966. 

Mr. PORTMAN. October 1966? OK. Again, do you believe that she 
understood the risks involved and the benefits involved in the 
treatment that she received? 

Ms. Nelson. No. If she was told anjrthing about it, she didn't un- 
derstand it. 

Mr. PoRTMAN. Did she? 

Ms. Nelson. She was illiterate. She couldn't read or write. 

Mr. Portman. Did she ever talk to you or other family members 
about it? 

Ms. Nelson. She never mentioned it. We never knew an3rthing 
about it until we read it in The Enquirer. That is when we were 
first informed of it. 

Mr. Portman. And in terms of the Grovemment's role, the De- 
partment of Defense's role, did she ever bring that up, or did you 
have any inkling of that? 

Ms. Nelson. She never talked about any of that. We never heard 
anything about any of that until we read about it in The Enquirer. 

Mr. Portman. So it was not until this year that you had any in- 
kling of that? 

Ms. Nelson. That is right. 

Mr. Portman. Thank you. 

Ms. Hager, do you know whether your dad was ever told about 
the existence of a military study? 

Ms. Hager. No. He had two sons in the military, and I am sure 
if he had been told, he would have told us. He told me just about 
everything he signed. He told me just about everything that they 
did to him. Him and I were very close right at the end, and he told 
me pretty much of what was going on. He knew nothing of this at 
all. 

Mr. Portman. He knew nothing of the DOD involvement? 

Ms. Hager. Of the Government being involved. He knew nothing 
of that. I am sure if they would have come and talked to him and 
told him that, you know, Mr. Mitchell, you are not going to live, 
maybe a couple of more months or so, and they would have ex- 



26 

plained this to him, he might have said, well, you know, go ahead 
and do it. But with him not knowing, no. 

He was a man that loved his wife and he loved his family, and 
he would have wanted to spend as much time as he had left with 
his — ^with my mother. Because he hated — did he not want to leave 
her behind. That was his one main thing of getting better; is he 
did not want to leave her behind. 

Mr. PORTMAN. Just one specific question. It relates to the letter 
he wrote to your sister, Isabell. He says in the letter that the doc- 
tor is not giving out the right news to the family. Chairman Bryant 
talked about the timing of this. I understand this is in relation to 
the initial operation that never took place. But how did you read 
that? Does that mean that he thought the doctors were trying to 
mislead the family, or that the doctors just didn't have good news 
for the family concerning his condition? 

Ms. Hager. What he didn't know was the doctors were not tell- 
ing the family anything. The doctors did not tell us about the oper- 
ation that he was going to have. The doctors never told us any- 
thing. This letter that my sister showed me, she showed me the 
week we had the meeting with David Msinn. I knew no idea of this 
letter. I could have told him, dad, the doctors are not telling the 
family nothing. We know nothing. They are not keeping us in- 
formed at all. 

I asked the nurse every night I left his room, I would make it 
a point to go to the nurse's station and say, if my father gets worse, 
please call me, no matter what time, CEill me, because I want my 
mother there, and I want to be there. We lived 10 minutes from 
Cincinnati General Hospital. I never received one phone call, noth- 
ing. 

When my dad passed away, my brother made a trip to the hos- 
pital. He found him in a private room. When we left him the night 
before, he was in a ward. We left him; they let me stay there that 
night until 9:30, quarter to 10, to be with him. When my brother 
went back the next day, he was in a private room. He said, my fa- 
ther was in a private room — my dad was in a private room. I said, 
your dad has never been in a private room. 

But they moved him when they know that he was d3dng. But 
they never picked up the phone and they never called me to let me 
know that my dad was dying. And I begged them to let me know. 

Two days before he died, he begged me to bring him out of that 
hospital. He said, they are not doing what is right with me. Take 
me home. And the nurse pulled me aside and said, just agree with 
your dad, go along with what your dad said, because he can't go 
home. And I had to leave him. 

They didn't do what was right by my dad and by any other pa- 
tient that was in there connected with this treatment. They were 
wrong. They know they were wrong. And it is about time they 
stand up and they say they were wrong. 

Mr. PORTMAN. Thank you, Ms. Hager. 

Mr. Bryant. On behalf of the subcommittee, I would like to 
thank each of you for coming forward and giving us a personal 
angle on this whole matter and taking the time to take off in the 
middle of the week and come up here and let the subcommittee see 
exactly how this has impacted your individual families. 



27 

I thank each of you for being here. 

Mr. Bryant. At this time we would like to ask the second panel 
to come forward, which consists of Dr. Gordon K. Soper, Principal 
Deputy to the Assistant to the Secretary for Atomic Energy in the 
Department of Defense; Dr. James Cox, professor of radiotherapy, 
M.D. Anderson Cancer Center, and chairman. Radiation Therapy 
Oncology Group; and Dr. Joseph Steger, president of the University 
of Cincinnati. 

Dr. Steger, you are also accompanied by Mr. Stan Chesley, cor- 
rect? 

Mr. Steger. Yes. 

Mr. Chesley. I am here as counsel, Mr. Congressman, Congress- 
man Bryant, just here as an assistant, to assist Dr. Steger in any 
way I can. 

Dr. Soper, please proceed. 

Mr. Bryant. Dr. Soper, can we begin with you? 

STAT EMEN T OF DR. GORDON K. SOPER, PRINCIPAL DEPUTY 
TO THE ASSISTANT TO THE SECRETARY FOR ATOMIC EN- 
ERGY, DEPARTMENT OF DEFENSE 

Mr. Soper. Thank you very much, Mr. Chairman, members of 
the subcommittee. I am Grordon Soper and I represent the Depart- 
ment of Defense at this hearing. 

With me are two of my colleagues from the Department of De- 
fense. Capt. Robert Bumgamer, Medical Corps, U.S. Navy, is the 
Director of the Armed Services Radiobiology Research Institute and 
is an expert in military medicine. It may also be useful to hear 
from Col. John Fraser Glenn, who is an expert on the Federal, De- 
partment of Defense, and Army's rules on human use experimen- 
tation. 

You have already commented on the extensive effort the adminis- 
tration is conducting to uncover the facts surrounding past radi- 
ation experiments. I can only tell you, the Department of Defense 
pledges to you our unqualified commitment to a thorough and com- 
plete search of all of the records. 

My purpose today is to provide you with a summary of the role 
that the Department of Defense played in the human radiation 
studies conducted at the University of Cincinnati from 1960 to 
1972. My report to you is based upon reports, files and documents 
that we have been able to locate from wide and varied sources. 

Most of the official Department of Defense records were retired 
and then destroyed long ago as part of the normal regulatory in- 
structions for disposal of contract files. And as such, what I am 
going to tell you or summarize for you is not newly uncovered in- 
formation. 

The entirely unclassified University of Cincinnati studies have 
been extensively reported in the open literature. They have been a 
subject of peer review, review by the American College of Radiol- 
ogy, congressional hearings, and as all of you know, a series of 
news articles starting as far back as 1971; all of these reviews have 
in one way or another addressed the Department of Defense's in- 
volvement. 

Now these studies will be further reviewed by a blue ribbon advi- 
sory committee on human radiation experiments, which was just 



28 

recently established by President Clinton. This committee is com- 
posed of eminent scientists, physicians, legal experts, and medical 
ethicists; and their purpose is to advise and guide the Grovemment 
on the larger questions of ethical and scientific standards of any 
Government-sponsored experiments which involved the intentional 
exposure of humans to ionizing radiation. 

A major goal of what we have been doing in DOD is to retrieve 
as many of the records as we possibly can of all DOD involvement 
in human experimentation, particularly that of the University of 
Cincinnati, and to provide a complete record of this to the advisory 
committee for their review. 

I would like to give you a brief summary of the Department of 
Defense support to this research, and for those of you who are in- 
terested, a more detailed chronology is attached to my submitted 
testimony. 

As you all know, in September 1958, Dr. Eugene Saenger of the 
Department of Radiology, University of Cincinnati College of Medi- 
cine, as the principal investigator, submitted what was called an 
unsolicited proposal to the Research and Development Division of 
the Army Surgeon General's Office; and as you have already stat- 
ed, the application proposed to research metabolic changes in hu- 
mans following total body irradiation, so that we could develop a 
simple urine or blood test to detect how much radiation an individ- 
ual had received. 

This unsolicited proposal was reviewed over the next year within 
the Department of Defense, and the available remaining docu- 
mentation reveals that at least five Army Medical Corps officers re- 
viewed the proposal and recommended approval of the contract ap- 
plication. 

In October 1959, staff" elements of what we call the Defense 
Atomic Support Agency recommended that they negotiate a con- 
tract with the University of Cincinnati for the study. So in early 
1960, I think it was the first of January 1960, a contract was en- 
tered into between the Defense Atomic Support Agency, now called 
the Defense Nuclear Agency, and the University of Cincinnati 
board of directors. 

The contract provided $25,058 for the initial study, and over the 
contract period — there were three separate contracts — ^between 
1960 and 1971, a little more than $650,000 was spent on this ef- 
fort. 

Let me say just a few words about the reason for the Department 
of Defense involvement. The search for a biological marker of radi- 
ation exposure was one steadfast aim of the University's research 
for the Department of Defense over the life of these contracts. And 
I will also say that the results of the research contributed in a gen- 
eral way to a better understanding of the influence of radiation ex- 
posure on the combat effectiveness of military personnel, and it 
provided a more suitable method for diagnosis, prophylaxis and 
treatment of radiation effects on the nuclear battlefield, a very 
fearful possibility at that time. 

Department of Defense funds were used for laboratory studies 
and psychological and psychiatric tests of cancer patients that re- 
ceived this whole or partial body radiation for treatment of their 
disease. No Department of Defense funds were used for direct pa- 



29 

tient care, nor did the Department of Defense play any part in pa- 
tient selection or their choice of treatment. 

The University of Cincinnati submitted 10 reports to the Depart- 
ment from 1961 to 1972; they are a part of the record. I have pro- 
vided a copy of these reports to your offices along with other rel- 
evant documents in our possession. 

Certainly, in reviewing these materials, Mr, Chairman, we at 
DOD can understand the controversy that arose in the early 1970's 
and continues to this day. Some of the records, as Congressman 
Mann said, especially from the viewpoint of 30 years later, are 
troubling and raise understandable concerns. Examples include 
statements in the University's early progress reports to the DOD 
that only nonradiosensitive tumors were selected for the research 
which some see as an indication of nontherapeutic purpose. 

Some see the inadequacy of the informed consent procedures. On 
the other hand, for example, in 1972 the American College of Radi- 
ology concluded that the research was validly conceived and carried 
out, the patient selection conformed with good mediced practice, 
and that consent procedures complied with applicable standards. 

We in the Department do not at this point seek to resolve these 
apparent contradictions. Our main focus, Mr. Chairman, is to com- 
pile as complete a record as we can, make it available to the Presi- 
dent's Advisory Committee and to the public for their study. 

Today, DOD-supported research is governed by the so-called com- 
mon rule — the Federal Policy for Protection of Human Subjects — 
and a copy of this regulation is attached to my statement. DOD is 
a full partner in the Grovemment's commitment to this standard. 

Under these regulations, today, a proposal like that from the 
University of Cincinnati in 1958 would require much more support- 
ing documentation and justification to be considered for funding 
support by the Department of Defense. 

During the course of these hearings, perhaps I could have the op- 
portunity to expand upon this point more thoroughly. 

So, Mr. Chairman, I have given you a very top-level summary of 
what we know so far. We are continuing to track down further in- 
formation. 

We sincerely appreciate the openness of the University of Cin- 
cinnati in sharing with us their records. We appreciate the local 
press sharing their records with us also. This hearing will also be 
a contribution to the knowledge-gathering process. 

We agree, in the Department of Defense, with the need to air 
once again the issues surrounding this early chapter of our Govern- 
ment's human use research. Our sincere goal is to pull together as 
complete a record as we can of our involvement and provide it to 
the President's Advisory Committee for their detailed study and ul- 
timate release to the public. 

Thank you for your attention, sir. 

Mr. Bryant. Thank you. 

[The prepared statement of Dr. Soper follows:] 



30 



STATEMENT 

OF 

GORDON K. SOPER, PRINCIPAL DEPUTY 

ASSISTANT TO THE SECRETARY OF DEFENSE 

FOR ATOMIC ENERGY 

BEFORE THE 

SUBCOMMITTEE ON ADMINISTRATIVE LAW 

AND GOVERNMENT RELATIONS 

CINCINNATI, OHIO 

APRIL 11, 1994 

Mr. Chairman and Members of the Subcommittee, I am Gordon 
Soper the Principal Deputy in the Office of the Assistant to the 
Secretary of Defense for Atomic Energy. I am here to support 
your request of March 24th to conduct hearings on radiation 
experiments performed by the University of Cincinnati Medical 
School which were funded in part by the Department of 
Defense (DoD) . 

If I may, Mr. Chairman, I'd like to provide a prelude to my 
testimony in order to put our efforts into context. Since early 
January, when the White House called for the formation of a 
senior level Interagency Working Group to coordinate the 
government-wide effort to uncover the nature and extent of any 
government sponsored experiments on individuals involving 
intentional exposure to ionizing radiation, the Department of 
Defense has been engaged in an extensive effort to discover the 
facts surrounding DoD sponsored human radiation experiments. 

It goes without saying that the Department takes this action 
seriously, that it has the complete support of Secretary Perry 
and that we pledge to you our unqualified commitment to a 
thorough and complete search of all available records and the 
full public release of the pertinent information in those 
records. As Dr. Harold Smith, the Assistant to the Secretary of 
Defense for Atomic Energy, and the DoD focal point for this 
action, testified to you at your February 2 hearing on this 
subject, the retrieval of records is a discovery process 
requiring time intensive "detective work" — we are well into that 
process now and beginning to make excellent headway. I would be 
glad to take any questions that you might have regarding the 
Interagency Working Group process and the results we have 
obtained so far. 

With that as background, I'd like to provide you with as 
complete a report as I can on the role that the Department of 
Defense played in the human radiation experiments conducted at 
the University of Cincinnati College of Medicine from 1960-1972 
which were led by the principal investigator. Dr. Eugene L. 
Saenger, MD. My report to you is based on documents, reports and 
files that we have thus far been able to locate from wide and 



31 



varied sources — some of the official Department of Defense 
records were destroyed long ago as part of the normal regulatory 
instructions for disposal of contract files. 

What I am going to report to you is really not newly 
uncovered information. The entirely unclassified University of 
Cincinnati studies have been previously reported in ten technical 
reports, 17 publications, and 26 presentations at scientific 
meetings; they were the subject of peer reviews at the University 
of Cincinnati; discussion of this work appears in the 
Congressional Record in 1971 and 1972; they were the subject of a 
report by the Comptroller General of the United States in 1972 
for Senator Edward Kennedy, Chairman of the Senate Health 
Subcommittee; they were the subject of a separate investigation 
in a report by the American College of Radiology in 1972, at the 
request of U.S. Senator Mike Gravel; and they were — and continue 
to be — the subject of news articles in the press and other media 
reports . 

In addition, Mr. Chairman, these studies will be further 
reviewed by the Advisory Committee on Human Radiation Experiments 
which just recently established by President Clinton. This 
Committee is composed of eminent scientists, physicians, legal 
experts and medical ethicists. Its purpose is to advise and 
guide the government on the larger questions of ethical and 
scientific standards of any government sponsored experiments 
which involved the intentional exposure to ionizing radiation. 
Specifically, as stated in the Executive Order issued by 
President Clinton in January: "The Advisory Committee shall 
consider whether (A) there was a clear medical or scientific 
purpose for the experiments; (B) appropriate medical follow-up 
was conducted; and (C) the experiments' design and administration 
adequately met the ethical and scientific standards, including 
standards of informed consent, that prevailed at the time of the 
experiments and that exist today." A major goal of DoD's 
"detective work" regarding the University of Cincinnati research 
is to provide a complete record for review by the Advisory 
Committee. 

Next I want to run through a brief chronology of this 
research, based on the record compiled to date, focusing on the 
Department of Defense sponsorship. 

In September, 1958 Dr. Eugene L. Saenger of the Department 
of Radiology, University of Cincinnati College of Medicine, as 
the principal investigator, submitted an unsolicited research 
proposal to the Research and Development Division of the Army 
Surgeon General's Office. The research proposal was initiated by 
the University of Cincinnati and not solicited by the Department 
of Defense. The application proposed to research metabolic 
changes in humans following total body irradiation for the 
purpose of determining whether the presence of amino-aciduria in 



32 



humans after radiation would provide a reliable biological marker 
of radiation exposure. Restated less technically, the original 
goal was to try to develop a simple urine test to detect the 
amount of radiation exposure. The University of Cincinnati 
requested approximately $25,000 for the first year and $21,000 
for two subsequent years. The proposal stated that Dr. Saenger 
was at that time also conducting pediatric cancer research funded 
by the National Institutes of Health, and preparing a Handbook on 
Medical Aspects of Radiation Accidents, under contract from the 
U.S. Atomic Energy Commission. 

This unsolicited proposal was reviewed over the next year 
within the Department of Defense. Available documentation 
reveals that at least five Army Medical Corps officers reviewed 
the proposal. They recommended approval of the contract 
application. In October 1959 staff elements of the Defense 
Atomic Support Agency (DASA) recommended that DASA negotiate a 
contract with the University of Cincinnati for the study of the 
metabolic changes in humans following total body irradiation. 

At that time a need existed within the Department of Defense 
to be able to determine the biological, statistical and clinical 
features of radiation injury. This was based on the requirements 
of our military commanders in the field to predict the outcome of 
human exposure to ionizing radiation, to predict the number of 
persons requiring hospitalization and to estimate the decrement 
in work capacity after radiation exposure on a nuclear 
battlefield. Remembering the context of the late 1950' s, where 
fallout shelters were common in homes and schools and superpower 
tensions dominated public affairs, this was a real possibility of 
that time. Furthermore, such information would aid civil defense 
authorities in their efforts to combat the effects of nuclear 
explosions on the civilian population. I believe the fairly 
recent Chernobyl nuclear power reactor explosion underscores the 
importance of being able to ascertain radiation exposure effects 
and also understand its impact on a subject population. 

So, in early 1960, a contract (DA-49-146-XZ-029, dated 
1 January 1960) was signed between DASA and the University of 
Cincinnati Board of Directors. The contract provided $25,085 for 
the study. This contract, with supplements and modifications, 
funded the study through February, 1964. Another contract 
(DA-49-146-XZ-315) carried the research until April, 1969. The 
final contract (DASA-01-69-C-0131) , effective May, 1969, funded 
the research until March, 1972 when the University of Cincinnati 
refused DASA' s offer for additional contract funding. Through 
1971, the DoD spent $651,482.79 on this research. 

While the search for a biological marker of radiation 
exposure was one steadfast aim of the University's research 
effort over the life of the contract, the goals of the Department 
of Defense were to also understand better the influence of 



33 



radiation on the combat effectiveness of troops and to develop 
more suitable methods of diagnosis, prognosis, prophylaxis and 
treatment of radiation injuries. In order to obtain this 
information, the Department of Defense provided funds for 
laboratory, psychological and psychiatric tests to assess the 
effects of varying doses of whole and partial body irradiation 
for the treatment of cancer patients. No funds were paid to the 
University of Cincinnati for direct patient care nor did the 
Department of Defense play any part in patient selection or 
choice of treatment. 

The University of Cincinnati College of Medicine submitted 
ten reports to the Department of Defense from 1961 through 1972 
in accordance with the terms of the contract. I have provided 
the committee a copy of these ten reports as well as a number of 
other relevant documents that we have in our possession. 
Attachment 1 to my statement is a chronology summarizing major 
parts of the record compiled to date. 

In reviewing these materials, we at DoD can understand the 
controversy that arose in the early 1970' s, involving the 
University community, the press, and the Congress, and that which 
has reemerged this year, regarding this research. Some of the 
records, especially from the viewpoint of 30 years later, are 
troubling and raise very understandable concerns. Examples of 
these include statements in the University's early progress 
reports to the effect that only patients with non-radiosensitive 
tumors were selected for the research, which some see as evidence 
of a non-therapeutic purpose, and that symptoms and side effects 
were not described to the patients, which some see as evidence of 
the inadequacy of the informed consent procedures . On the other 
hand, for example, the 1972 peer review of the American College 
of Radiology, carried out at the request of Senator Mike Gravel, 
concluded that the research was validly conceived and executed, 
that the patient selection conformed with good medical practice, 
and that consent procedures complied with applicable standards. 
We at DoD do not at this point seek to resolve these apparent 
contradictions. Rather, our sole focus regarding this task is to 
compile a complete record and to make it available to the 
President's Advisory Committee and to the public. 

Before concluding my statement, I want to address the 
constraints which the Department of Defense imposes on human 
subject experiments today and how we would respond to an 
unsolicited proposal, like the 1958 proposal from the University 
of Cincinnati College of Medicine, for experiments in which 
humans would participate. 

Formal DoD policy for the protection of human subjects in 
research date back to at least 1953, when a then TOP SECRET 
Memorandum was sent to the Secretaries of the Services from 
Secretary of Defense C.E. Wilson, titled "Use of Human Volunteers 



34 



in Experimental Research" . This memorandum authorized the 
voluntary participation of military personnel and civilian 
employees in DoD conducted research for atomic, biological and 
chemical warfare defense and established specific standards for 
informed consent, minimization of risk of harm to subjects, and 
other matters. 

Over the years, more detailed procedures were established, 
including incorporation in 1991 of the 1974 Department of Health 
and Human Services regulations for the Protection of Human 
Subjects, 45 C.F.R. Part 46. 

Today, DoD-supported research is governed by the so-called 
"Common Rule" — the Federal Policy for the Protection of Human 
Subjects — which is part of DoD regulations at Title 32, Code of 
Federal Regulation, Part 219. A copy of this regulation is 
attached to my statement. DoD is a full partner in the 
government's commitment to this standard and has further defined 
its human use regulation in DoD Directive 3216.2, "Protection of 
Human Subjects in DoD Supported Research," January 7, 1983 and 
Department of Defense Guidance for Assurance of Compliance with 
the Federal Policy for the Protection of Human Subjects, June 10, 
1993, 

Under these regulations, a proposal like that from the 
University of Cincinnati would require much more supporting 
documentation and justification to be considered for funding. 
This includes the following: 

1. The therapy itself, separate from the research, would 
require more information on the possible benefits and the known 
side effects. 

2. Several local committees (specifically, scientific, 
radiation and Institutional Review Boards, or IRBs), would have 
to review the proposed research protocol package, with proposed 
consent forms, before DoD would review the proposal for 
acceptance. 

3. It would be required that the sponsor's Institutional 
Review Board be made up of people from diverse backgrounds, 
including non-scientific perspectives, who could objectively and 
fully assess the proposal. 

4 . The IRB record would have to document that the research 
design is sound, that risks to subjects are minimized, that the 
selection of subjects is equitable, and that, if applicable, 
special protections have been adopted for any vulnerable groups 
mentioned. 

5. A written consent form signed by the pat lent /subject 
would be required for participation in the research. This 



35 



consent form would require an explanation of the proposed 
therapy, all procedures and studies to be performed, and all 
expected outcomes and side effects in laymen's terms. The 
consent form must also state that the patient has been counseled 
cibout all of the above, and space provided for the patient to 
sign stating this has occurred and that the patient understands 
it. 

6. The protocol would be required to justify withholding 
radiation in the control group of patients if such radiation 
therapy were the standard of care for the cancer each patient 
had. 

7. The investigator would be required to give a more in 
depth description of the known and suspected risks and the 
intended benefits of the research for the subject. 

In other words, Mr. Chairman, we believe we have in place a 
set of guidelines for human use experimentation that will 
preclude 30 years from now, hearings like we are conducting 
today. 

So in summary, Mr. Chairman, the DoD received from the 
University of Cincinnati College of Medicine in 1958 an 
unsolicited proposal, which resulted in a contract from 1960 to 
1971 supporting a human radiation experiment. DoD played no role 
in the selection of subjects, decisions regarding treatments, or 
the day-to-day conduct of the research. DoD received a series of 
reports describing the research results, none of which were ever 
classified. Data that we obtained from the University of 
Cincinnati studies were used to enhance our knowledge about the 
biological response to nuclear warfare — knowledge that we all 
hope will never have to be put to use. We well understand the 
controversy regarding this research, but make no effort at this 
time to resolve apparent contradictions in the voluminous record 
compiled to date. Our goal is to compile a complete record for 
the use of the President's Advisory Committee and ultimate 
release to the public. 

That concludes my prepared remarks. I would be happy to 
take your questions. 



36 



CHRONOLOGICAL SUMMARY -- DASA/DHA REPORTS 

1. General Observations: 

a. Dr. Saenger submitted ten reports to DASA/DNA from 1961 
through 1972 in accordance with the terms of his contract. 

b. The reports provide a means to trace the expansion of the 
research's scope, increased sophistication of techniques, and 
ambitiousness of future plans. The reports were similar in that 
they stated the purpose of and criteria for the research, 
research structure and techniques, how the work was conducted, 
the results of the experiments, observations and analysis of the 
data, plans for future study, and individual case histories of 
patients observed during the reporting period. 

2. General information about DoD sponsorship of radiation 
experiments at the University of Cincinnati 1960-1971. 

1958 In September, 1958 Dr. Saenger submitted an 

unsolicited research application to the Research 
and Development Division of the Army Surgeon 
General's Office. The application proposed to 
research metabolic changes in humans following 
total body radiation for the purpose of 
determining whether the presence of amino-acidura 
in humans after radiation would provide a reliable 
biological marker of radiation exposure. Dr. 
Saenger requested approximately $25,000 for the 
first year and $21,000 for two subsequent years. 

1958-1959 Over the next year the proposal was reviewed 
within the Defense Department and a contract 
negotiated. Available documentation reveals that 
at least four Army Medical Corps and one Medical 
Service Corps officer reviewed the proposal. They 
recommended the contract application be approved. 
In October, 1959 the Defense Atomic Support 
Agency's (DASA) Deputy Chief of Staff, Weapons 
Effects and Test requested, thru the Chief, DASA, 
the Contract Management Branch, Directorate of 
Logistics negotiate a contract with the University 
of Cincinnati for the study of the metabolic 
changes in humans following total body radiation. 

I960 In early 1960 a contract (DA-49-146-XZ-029, dated 

1 January 1960) was signed between DASA and the 
University of Cincinnati Board of Directors. The 
contract provided $25,085 for the study. This 
contract, with supplements and modifications. 



37 



funded the study through February, 1964. 

The first contract stated the technical scope of 
the research was "to study the phenomen of amino - 
acidura following irradiation, a condition which 
has been reported in humans and animals, to 
clarify some of the mechanisms responsible for 
amino-acidura and to determine whether it is a 
practical biological test of radiation exposure." 
The search for a biological marker of radiation 
exposure was one constant of Dr. Saenger's 
research effort over the next decade. 

1961 On 28 February 1961 the Cincinnati project's 

contract was modified for the first time. The 
contract was modified to establish a new date for 
work completion to provide additional time for 
research on amino-aciduria following irradiation; 
amended the technical scope of the work to meet 
additional objectives of the government; provided 
additional funds to meet research requirements 
under the amended scope of work; altered portions 
of the contract to bring the contract in 
accordance with Armed Services Procurement 
Regulations that became effective subsequent to 
the signing of the original contract . The 
contract amount increased almost $30,000 from 
$25,000 to $54,000 and the length of the project 
was extended from February, 1961 to April, 1962. 
The scope of the work was expanded by three 
requirements: a breakdown of desoxyribonucleic 
acid and is derivatives in patients receiving 
total body radiation; DNA studies on patients who 
received partial irradiation and radiomimetic 
chemotherapeutic agents; and preliminary 
determination of appropriate psychometric tests. 

1961 In June, 1961 the contract was modified for the 
second time. An additional $650 was allocated to 
use the technical services of a French authority 
on radiobiology at a Whole Body Radiation 
Conference to be held by DASA at the University of 
Cincinnati in October, 1961. 

1962 In April, 1962 the project's contract was modified 
for the third time. The contract total was 
increased approximately $39,000 to $94,400. The 
project completion date was extended to April 30, 
1963. The scope of work was also further 
expanded. Three additional objectives were added. 
Additional studies were to be made of - -increasing 
the upper range of radiation dose to 150-200 rad. 



38 



and single doses of nitrogen mustard or other 
radiomimetic drug using .4mg/kilo. The following 
tests were to be conducted for 9 days post- 
treatment- -urinary taurine for correlation with 
leukocyte count, BAIBA in urine, Kynurenic and 
xanthurenic acids, deoxycytidine, DNA fragments in 
urine, et al , xanthine and hypoxanthine in urine, 
urinary phosphate, and glutathione. The test were 
to be done over a 30 day period- -routine 
electrophresis , immunoelectrophoresis , 
quantitative precipitin studies, serum urea 
nitrogen and/or serum creatine once weekly, 
urinalysis once weekly and as needed, routine 
hematology, and completion of the manuscript of 
the DASA Conference on Total Body Irradiation of 
October, 1961. 

1963 On April 1, 1963 the contract was modified for the 
fourth time. The contract was extended through 
April 30, 1964. Funding was increased $40,000 to 
$134,56. The scope of the work was further 
amended. Test to be conducted over a 30 day 
period between March 1, 1962 and February 28, 1963 
were to be: (1) routine electrophesis, (2) 
immunoelectrophesis, (3) quantitative precipitin 
studies, (4) serum urea nitrogen and/or serum 
creatine once weekly, (5) urinalysis once weekly 
or as needed, and (6) routine hematology. During 
the same year the following tests were to be 
conducted over a 42 day period included 3, 4,, 5, 6 
and chromosome cultures of peripheral blood. 

1964 Contract DA-49-146-XZ-315 came into effect and 
funded the research from February, 1964 to April, 
1969. 

1965 Ralph C. Rursiek and Dr. Eugene L. Saenger wrote a 
letter, dated May 17, 1965, to Director, Defense 
Atomic Support Agency, ATTN: STMD requesting 
that NWER No. 03.009 be funded at an estimated 
cost of $45,000 for FY65. The overall objective 
was to study various phenomena of 
desoxyribonucleic acid breakdown and other 
abnormalities following whole or partial body 
irradiation of human beings. Fifteen patients 
were to be studied. The project intended to study 
patients for 5-14 days prior to irradiation and 
for as long as possible after to evaluate clinical 
hematological and psychological changes. 
Investigation of the metabolism and urinary 
excretion of deoxycytidine was to be continued. 
Bone marrow was also to be stored prior to 



39 



irradiation. All serum was to be sent to Dr. 
Luzzio at Fort Knox. 

1967 In 1967 a member of the University of Cincinnati 

research team, Dr. James G. Kereiakes, attended an 
Atomic Energy Commission sponsored conference at 
Oak Ridge, Tennessee. A purpose of the conference 
was to refine the dosimetric aspects of whole and 
partial body irradiations being used by the 
medical community to treat leukemia and widely 
disseminated cancers. The aim of the conference 
was to standardize the dosimetry being used to 
report patient dose. Information developed at the 
conference revealed 1,835 patients at about 35 
institutions had received whole or partial body 
irradiations for the palliation or treatment of 
cancers. The use of radiation was widely spread 
and acknowledged as an effective modality. 

1969 The final contract (DASA-01-69-C-0131) , effective 

May, 1969 funded the research until March, 1972 
when the University of Cincinnati refused DASA' s 
offer for additional contract funding. 

1971 Dr. Eugene L. Saenger wrote a letter, March 22, 

1971, to Dr. Robert Loind, DASA, Attn: STMD . The 
cover letter with attachments forwarded the 
projects proposal for FY 73. The proposal 
requested $70,000 for a study entitled "An 
Appraisal of Human Studies In Radiobiological 
Aspects of Weapons Effects". A six page 
description of the study's philosophy, the role of 
future human research in relation to the remainder 
of the radiobiology program, specific areas of 
endeavor (eight- -clinical evaluation, metabolic 
effects, behavioral effects, dose response 
studies, partial body studies, prognosis, 
therapeutic methods, use of healthy volunteers) , 
and future plans regarding funding. 

1960-1971 Through 1971 DoD ultimately spent over $650,000 on 
Dr. Saenger' s endeavors which treated 85 adults 
whole- or partial-body radiation. Three children 
with localized Swing's tumor were also treated 
with whole-body radiation. DoD funds were 
provided for laboratory, psychological and 
psychiatric tests to assess the effects of varying 
doses of whole and partial body irradiation. No 
funds were paid to the University of Cincinnati 
for direct patient care. 

3 . Report Summaries 



40 



1960-1961 The report for the first research period (February 
19, 1960 to October 31, 1961) was DASA 1422 
Supplement, which was entitled Metabolic Changes 
in Humans Following Total Body Irradiation . This 
title was used for the reports through 1967. The 
report provides a detailed itemization of the 
investigations and study projects. The aim of the 
studies was "to obtain new information about the 
metabolic effects of total body and partial body 
irradiation so as to have a better understanding 
of the acute and subacute effects of irradiation 
in the human." During this period ten patients 
received total body irradiation in doses that 
ranged from 16 to 150 rads . Patients were selected 
for the study were those with "proven metastatic 
or far advanced cancer... in relatively good 
nutritional status, i.e., able to maintain their 
body weight .... [and] have normal hematological 
values." An explanation of one of the study's 
technique stated "the patient is told that he is 
to receive treatment to help his sickness. There 
is no discussion of subjective reactions resulting 
from the treatment. Other physicians, nurses and 
ward personnel are instructed not to discuss these 
aspects with the patient." The remainder of 
report discussed on-going studies, clinical 
observations, dosimetry, and other study 
techniques supplemented with tables and patient 
case histories. 

1961-1963 The second report, DASA 1422 reported on the 

research from November, 1961 to April, 1963. Ten 
patients were treated with total body radiation in 
doses that ranged from 150-200 rad during the 
report period. The study's statement of aims was 
identical to that of the previous report except 
that it was expanded. The added aim stated "This 
information is necessary to provide knowledge of 
combat effectiveness of troops and to develop 
additional methods of diagnosis, prognosis, 
prophylaxis and treatment of these injuries." 
Patient selection criteria was more refined. In 
addition to those already stated new criteria was 
that "patients with lymphoma [were] 
excluded. . .Patients with solid neoplasms not 
radiosensitive are sought." The technique 
reported previously remained in use. Verbal 
consent of the patients was obtained prior to 
treatment. 

One of the issues the researchers encountered 
involved complications in trying to determine the 



41 



effects of radiation. the report stated 
"Physicians assess patient to be certain that the 
underlying disease can be evaluated. Thus, there 
was difficulty in selection of patients for 
assessment of radiation effects because of 
underlying disease. Patients previously treated 
by radiation or chemotherapy were excluded because 
previous treatment confounded the response to 
radiation in several early patients." 

Throughout the narrative and near the 
conclusion with the researchers thoughts on "Human 
Effectiveness Following Whole-Body Irradiation". 
Several of their observations included: 

"Marked hematological changes occur 
generally between the 25th and 35th day following 
exposure. Maximum recovery to be obtained 
generally requires about 100 days." 

"Human beings recover slowly and are 
quite sensitive to radiation with multi-system 
involvement . " 

"Prodromal acute effects such a nausea, 
vomiting, anorexia, and lassitude are of the 
duration hours. Intermediate effects such as 
hematologic complications are to be conceived of 
in weeks . " 

"A previous dose of radiation does 
influence the incidence of acute effects. 
Therefore the incidence of 'combat effectiveness' 
will be significantly increased on re-exposure of 
an individual . " 

"...individuals with previous exposure 
to radiation will be less tolerant of subsequent 
exposures. hence troops previously exposed to 
150-300r of whole body radiation will tend to show 
more combat ineffectiveness in the prodromal 
period than will those who are unexposed." 

"This field of investigation has obvious 
important implications. Breakdown of DNA has long 
been implicated as the fundamental biochemical 
change of radiation and there is an impressive 
literature bearing on this point... The observation 
cited above of decrease of DOC after the 
administration of protective agents indicates the 
possibility of the use of specific prophylactic 
agents for the protection of 'humans in nuclear 
warfare . " 



42 



A final observation was offered on future study: 

"It is our opinion that human radiation 
studies need to be expanded. 

We propose to establish facilities for 
withdrawal, storage, and reinfusion of autologous 
bone marrow. As indicated elsewhere in this 
report we have encountered significant 
hematological difficulties with a dose range of 
200-325r. Therefore, to proceed with higher 
doses, we feel the need to protect our patients 
even if we might sacrifice their v£,lue for 
hematological evaluation after 2-3 weeks since the 
hematological effects are well documented. Once 
this technique has been developed as a support 
procedure we then anticipate increasing doses to 
higher levels. " 

Tables, figures and case histories rounded 
out the report. 



1963-1964 DASA 1633 was the report submitted for the period 
May 1, 1963 to February 29, 1964 during which six 
patients were treated with total body radiation 
doses between 100 to 150 rad. The aims of the 
study remained as previously reported. "Normal 
renal function' was added to patient selection 
criteria. The technique to limit subjective 
reactions treatment was unchanged. Proposals for 
human study expanded on the previous report's 
discussion of autologous bone marrow reinfusion. 
The report stated: 

"Storage and reinfusion of autologous bone 
marrow will be accomplished in the facility which 
has been established. . .The purpose of marrow 
storage and reinfusion is to protect subjects who 
receive doses in excess of 150 rad in the event of 
bone marrow failure. We hope to utilize doses 
between 200-300 rad." 

Tables and case histories once again 
accompanied the report . 



1964-1966 DASA 1844 covered not only the study years 1964 to 
1966 but also provided a summary of the first six 
years of the experiment . Midway through the 
decade the aims of the project were stated as: 

"This program is designed to obtain new 

7 



43 



information regarding the metabolic, physiologic, 
immunologic, hematologic, and biochemical effects 
of TBR and PBR in human beings. It will then be 
possible to understand better the influence of 
radiation on combat effectiveness of troops and to 
develop more suitable methods of diagnosis, 
prognosis, prophylaxis and treatment of radiation 
injuries. It is our belief that information 
concerning radiation effects in the human being 
can be determined as well or better in these 
subjects as in the laboratory animal even though 
the characteristic of cancer must be kept in mind 
in the evaluation of the data." 

On page 2 the aims were once again addressed 
in terms of the original scope of the study: 

"A major objective of these studies has been 
a search for a suitable biological indicator of 
radiation dose in human beings.... At this time the 
urinary excretion of deoxycytidine seems to be 
promising as a biological indicator." 

Another aim was stated on pages 2 and 3 . 

"Psychological and psychiatric testing has 
been started in 14 patients ... .This approach will 
provide information on another important parameter 
of combat effectiveness of troops." 

Later in the report an aspect of the 
psychiatric evaluation is further discussed. 

"One of the most difficult aspects of 
radiation injury requiring evaluation is that of 
performance decrement . This term is loosely used 
but in our laboratory it is defined as any 
decrease in ability to carry out assigned tasks." 

Patient selection criteria was more specific: 

"Patients with metastatic or incurable 
neoplasms are given whole partial body radiation 
for palliative treatment of their disease. 
Patients for the studies described in this report 
are selected from patients treated as described 
above providing that they satisfy the following 
criteria: 

1. The patients have solid tumors. 
Patients with lymphoma are excluded. 

2. Relatively good nutritional status 

8 



44 



(ability to maintain weight) . 

3. Normal renal function 

4 . Stable hemogram in the control 
period. " 

Twenty three additional patients were treated 
during the research period between 1964 and 1966. 
Of these patients 13 received total body radiation 
treatments with dosages between 25 and 150 rads. 
Partial body radiation doses between 100 and 300 
rads were used in the treatment of 10 patients. 

The technique to "isolate" patients from 
discussions of subjective reactions remained the 
same . 

Discussion of hematology stated: 

"Since severe hematological depression was 
found in most patients who expired, autologous 
bone marrow storage has been performed for 13 
patients. In only two patients has infusion been 
carried out. The method is being refined so as to 
include filtration prior to infusion. Although we 
have not encountered morbidity ... filtration 
appears to decrease the probability of incidence 
of pulmonary emboli." 

Accompanying the 35 page report were 122 
pages of tables, and case histories of the all 
patients treated to date. 

1966-1967 DASA 2179 described the treatment of four patients 
between May 1, 1966 and April 30 1967. Of the 
four patients treated one received total body 
radiation (150 rad) while the other three received 
partial body radiation doses in the range of 100- 
200 rad. Aims, patient selection criteria, and 
technique remained as previously reported. Three 
accomplishments were reported. The first 
involved "the completion of an infusion filtration 
system for reinfusion of autologous stored human 
bone marrow." As a result of the development the 
researchers stated "Since this instrumentation 
will make infusion of marrow a safer and more 
easily controlled procedure we feel that earlier 
infusion to prevent the hematological depression 
from radiation should be investigated." The text 
noted that the methods were described in a paper 
presented in Paris, France which cited DASA 
support . 

The second accomplishment was the "perfection 



45 



by Dr. I -Wen Chen of a new, much improved method 
for the determination of deoxycytidine (CdR) in 
urine from humans and from rats." 

The third involved "the growth of two strains 
of phage on synthetic culture medium." This 
development made it "possible to titrate antibody 
production in experimental animals and man before 
and after irradiation." 

Future plans included the evaluation of 
"alterations in antibody production and /or 
destruction in human beings due to radiation." 
Observations of this nature on "the effects of 
radiation exposure will yield a better 
understanding for military planning and triage." 

Tables, figures, and case histories 
supplemented the text . 

1967-1968 The report for the period May 1, 1967 to April 30, 
1968 was DASA 2168. The report's title changed to 
Radiation Effects in Man: Manifestations and 
Therapeutic Efforts . Reports carried this title 
for the remainder of research. This report 
recounted the treatment of seven patients. Four 
patients were treated with total body radiation 
doses between 100 and 200 rad. Three patients 
were treated with lower body partial body 
radiation doses of 200 to 300 rad. The report's 
forward noted "these studies were performed in 
conformation with the 'recommendations guiding 
doctors in clinical research' as stated in the 
Declaration of Helsinki of the World Medical 
Association (1964). Reported aims, criteria and 
techniques were as previously reported. Updated 
information from the psychiatric-psychological 
team noted "the number of patients who have been 
evaluated by the psychiatric-psychological team 
now totals 20." Hematology research continued. 
The researchers reported "seven patients received 
autologous bone marrow transfusions at completion 
of DADA 2168. Guidelines for quantity of marrow 
cells to be infused for successful transfusion and 
bone marrow protection were developed." 

Case histories and tables provided additional 
information. 



1968-1969 The research over the period between May 1, 1968 
and April 30, 1969 was the subject of DADA 2428. 
Eight patients were treated during this period. 
Total body radiation doses of 100-200 rad were 
given to six patients. Two patients were treated 
with 200-300 rad doses of partial body radiation. 

10 



46 



Once again the forward noted that the studies 
conformed to the recommendations of the 
Declaration of Helsinki. Aims and goals remained 
unchanged. In the field of hematology the report 
stated "success has finally been obtained in 
autologous marrow infusion which will permit us to 
employ higher doses of radiation in the coming 
year. Several new biological dosimeters are under 
evaluation." Tables and case histories 
accompanied the report . 

1969-1970 DASA 2599 reported on the research based on 

observations of twelve patients between May 1, 
196 9 and April 30, 1970. The recommendations of 
the Declaration of Helsinki were once again noted. 
A presentation by Dr. Edward B. Silberstein on the 
team's earlier work and the data contained in this 
report at the lAEA-WHO Conference in Paris on 24 
June 1970 was reported. 

During this period six patients were treated 
with doses of 100-230 rad of total body radiation. 
The other six patients received partial body 
radiation doses between 150 to 300 rad. Regarding 
these patients the report stated "Most of the 
patients had inoperable metastatic carcinoma which 
was not amenable to conventional chemotherapy. 
Nevertheless, these patients were all clinically 
stable, many of them working daily. Several of 
the subjects, apparently tumor free and clinically 
normal after regression of regionally irradiated 
tumors (Swing's tumor), received prophylactic 
whole body radiation." 

Hematological work, specifically related to 
biological dosimetry, was discussed. Several 
biological dosimetry issues were discussed. 

"We are pursuing this goal at whole -body 
radiation doses up to 250 rad with even higher 
doses planned with the support of marrow 
autotransfusions and laminar-flow 'sterile' rooms. 
Large-volume partial-body irradiation is also 
being performed to learn more about the efficacy 
of chromosome aberrations as a radiation dosimeter 
in the more frequent situation of inhomogeneous 
exposure. With a linear accelerator, we hope to 
study the effects of various dose rate in vivo as 
well." 

As for the continued research into the 
utility of deoxycytidine the report noted 
"deoxycytidinuria appears to be related to general 

11 



47 



tissue catabolism from several causes, including 
radiation. Other problems in using urinary CdR 
include variations in excretion due to race (57) 
and age (63)." [Note: Numbers in () are 
bibliographic reference numbers.] 

Tables and case histories were included with 
the report. Table XII provided "a summary of 
demographic and other pertinent data... for the 
entire group of 36 patients" observed since the 
start of testing. 

1970-1971 DNA 2751T was the report for the period May 1, 

1970 to April 30, 1971. Eight patients underwent 
treatment. Three received total body radiations 
dosages of 100-200 rad. Five underwent partial 
body radiation with doses of 300 rad. The 
research aims were restated. 

"The University of Cincinnati studies in 
radiation effect in man continues as a carefully 
integrated effort to maximize clinical, 
psychiatric, therapeutic, biochemical, and 
theoretical approaches to whole and partial 
therapeutic irradiation as given for palliation of 
certain selected cancers." 

To achieve these aims "the methods of 
applying radiation have remained essentially the 
same since the inception of these studies." 

Acknowledgement was made of guidance 
provided. 

"The nature of the specific projects 
undertaken in our laboratories reflects the 
consideration of many of our faculty and the 
thoughts and problems of the other DNA conferences 
organized over the past several years by Col E.J. 
Huycke. Valuable interchange of ideas have been 
stimulated by visitors from Department of Defense 
laboratories who give our staff a more practical 
insight into military problems than we might 
otherTtfise have . " 

Future plans were described. 

"Many of the new directions in our 
investigation stem from concurrent advances in 
cytogenics, organ transplantation, bio-chemical 
aspects of molecular biology, and clinical aspects 

12 



48 



of cancer therapy." 

"A renewed interest is manifested in 
chromosome aberrations as being eventually an 
index of 'effective radiation dose,' particularly 
since almost all exposures encountered in 
nontherapeutic circumstances will have varying 
degrees of nonuniformity of dose rate and dose 
distribution. " 

"As an outgrowth of our needs to afford 
maximum protection to patients receiving doses in 
the LD50 range, some new technical advances have 
been developed in bone marrow transfusion in 
patients . " 

Regarding biological dosimetry the report stated: 

"Yet in severely burned individuals 
deoxycytidine ( (deoxycytidine excreted in urine) ) 
occurs late (in 2 to 4 weeks) and in the several 
patients studied the levels seemed directly 
related to the extent and depth of the burn. 
Radiation induced deoxycytidinuria when found 
occurs within 2-3 days and then disappears. 
Additional studies may suggest this test as a way 
of differentiating relative contribution of these 
two modalities of injury." 

The usual tables and case histories 
supplemented the narrative. 

1971-1972 The final report in the series was DNA 3024F which 
was to be for the period April 1, 1971 to March 
31, 1972. However, its was really a summary of 
the entire research effort and was a "scientific 
communication presented at the meeting of the 
American Roentgen Ray Society in Washington on 3 
October 1972." It was further noted that "this 
report has been accepted for publication in the 
American Journal of Roentgenology, Radium Therapy, 
and Nuclear Medicine . " 

As stated in this report the research were 
"to improve the treatment and general clinical 
management and if possible the length of survival 
of patients with advanced cancer. Systemic 
effects of radiation therapy have been given 
particular attention in our work." 

The issue of informed consent was addressed. 

"All patients gave informed consent in 
13 



49 



accordance with directives of the Faculty Research 
committee of the University of Cincinnati College 
of Medicine and those of the National Institutes 
of Health. The use of formal informed consent 
forms in this study antedated the above 
requirements by two years. The project is 
reviewed and approved regularly by the above 
committee . " 

The report noted that "patients become 
eligible for this form of treatment if they have 
advanced cancer for whom cure could not be 
anticipated. .. .Chief among the reasons for 
elimination was an indication in the pretreatment 
phase that some risk from wide-filed radiation 
might ensue or that another method of treatment 
was considered preferable." 

From an analysis of radiation mortality "one 
can identify eight cases in which there is a 
possibility of the therapy contributing to the 
mortality. " 

A comparison is later made between times of 
death of those that entered the study and received 
radiation treatments, and those that entered the 
study and did not receive radiation treatments. 
From this comparison the report noted: 

"Fisher's exact probability test yields a p 
value of 0.16, indicating that there is no 
difference between the two groups. Therefore, one 
may conclude that in other patients described, the 
effect of whole- and partial-body radiation 
therapy was less important in contributing to 
death than was the extent of disease in these 
patients. Another interpretation would be that a 
physician selecting far advanced cancer patients 
for a given treatment would have about the same 
degree of difficulty in selecting any form of 
treatment for these very ill patients." 

Tables and figures accompanied the report as 
did a section entitled "Thermography as a 
Radiobiological Dosimeter" . 

1971-1972 Issues arise that lead to the termination of the 
contractual relationship between DNA and the 
University of Cincinnati. 



14 



50 



Project Chronology 
October 1971 - January 1973 

October 8, 1971 -- An article appeared in The Washington Post, 
"Pentagon Has Contract to Test Radiation Effect on Humans", by 
Stuart Auerbach and Thomas O' Toole that prompted the subsequent 
governmental investigations of the Cincinnati project. 

October 11, 1971 -- Dr. Eugene L. Saenger, Dr. Clifford G. Grulee, 
Dean of the University of Cincinnati College of .Medicine, and Dr. 
Edward A. Gall, Vice President of the University of Cincinnati and 
Director of the University of Cincinnati Medical Center, were 
present at a press conference the subject of which was the 
impending Senate and Government Accounting Office (GAO) 
investigations of the conduct of the Cincinnati project. 

October 11, 1971 -- A follow up article appeared in The Washington 
Post, "Pentagon's Radiation Experiments Defended". The article 
featured Dr. Saenger explaining the process of patients selection 
and Department of Defense (DOD) funding of the project. 

Mid-October 1971 -- DOD developed a Fact Sheet on the Cincinnati 
project that discussed its contractual arrangements with the 
University of Cincinnati. A copy of the Fact Sheet was later 
entered into the Congressional Record on December 15, 1971 as an 
attachment to a letter from the Assistant Secretary of Defense 
(Legislative Affairs) to Senator Robert Taft, Jr. 

November 10, 1971 -- Senator Mike Gravel wrote a letter to Dr. 
Robert W. McConnell, President of the American College of Radiology 
(ACR) requesting the ACR to conduct an evaluation of the Cincinnati 
Project . 

November 12, 1971 -- Dean Clifford G. Grulee appointed an Ad Hoc 
committee to review the "whole-body radiation study" which Dr. 
Eugene L. Saenger had been conducting at the University of 
Cincinnati Medical Center. The Ad Hoc committee, chaired by Dr. 
Raymond Suskind, Director, Environmental Health, University of 
Cincinnati, was made up of eleven members and was charged with 
reviewing the scientific content, methodology, and data treatment 
of this study, as well as other aspects which the committee deemed 
appropriate. All eleven committee members were professors at the 
University of Cincinnati. Ten committee members were medical 
doctors and one was a Ph.D. in Physiology. 

December 6, 1971 -- Mr. Ellis R. Mottur, Science Adviser to the 
Senate subcommittee on Health, Senate Committee on Labor and 
Public Welfare and Dr. Caper, both of Senator Kennedy's staff 
interviewed Dr. Edward B. Silberstein, University of Cincinnati 
Medical Center, Dr. Eugene L. Saenger, and others at Cincinnati 
General Hospital . 

December 6, 1971 -- Dr. Robert S. Daniels, Ptofessor and Director, 
Department of Psychiatry, University of Cincinnati, wrote a letter 



51 



to Dr. Raymond Suskind. The letter forwarded a list of question to 
Dr. Suskind for inclusion in a "our [Ad Hoc Review Committee] 
report on 'Total Body Radiation' project". 

December 7, 1971 -- Mr. Ellis R. Mottur of Senator Kennedy's staff 
requested the opportunity to conduct interviews with surviving 
project subjects. 

December 7, 1971 -- Dr. Eugene L. Saenger wrote a letter to Dr. 
Raymond Suskind, which discussed the impending arrival of the ACR 
Committee to review the project. 

December 13, 1971 -- The subject of interviewing patients was 
broached in a letter from Senator Edward Kennedy, acting in his 
role as Chairman of the subcommittee on Health, Senate Committee on 
Labor and Public Welfare, to Dr. Warren Bennis, President 
University of Cincinnati. 

December 17, 1971 -- Dr. Eugene L. Saenger wrote a letter to Dr. 
Charles Barrett, Department of Surgery, University of Cincinnati 
Medical Center. The letter details Dr. Saenger' s objections and 
concerns about providing patients to be interviewed. 

December 20, 1971 -- Dr. Eugene L. Saenger authored "Comments on 
Differences Between Therapeutic and Non- Therapeutic Investigation" . 
Dr. Saenger generally defended his research and methods by citing 
legal and medical opinions. He then went on to refute specific 
allegations that relate to DoD funding, informed consent techniques 
(Dr. Saenger made the point that since 1968 patients were told the 
information gained might be of use on the battlefield) , follow-up, 
alleged contributory effects of radiation to patient deaths, racial 
composition of study group, and the below average intelligence 
level of the project subjects. 

December 21, 1971 -- Dr. Eugene L. Saenger wrote a letter to Dr. 
Edward A. Gall. The letter was a response to Dr. Gall's request 
that Dr. Saenger identify patients that might be suitable for 
interviews by Mr. Mottur. 

January 1972 -- The Ad Hoc Review Committee chaired by Dr. Raymond 
Suskind of the University of Cincinnati communicated its report to 
the Dean of the College of Medicine concerning Dr. Saenger' s 
project. The Report contains seven sections, two of which are 
pertinent to DOD involvement; Section IV Financial Support of 
Program and Section V Informed Consent and Human Rights . 

In Section IV it is reported that the request for financial 
support for the project was initiated by the University of 
Cincinnati. The systematic investigation of whole body radiation 
did not begin until the project was funded by the Defense Atomic 
Support Agency (DASA) . Through March 1972 DASA had granted 
$651,483, 13% to 15% of the budget of the Radioisotope Division. 
Section IV also details the breakdown of expenditures. There is no 
evidence that the DASA funding was made contingent on work, ideas. 



52 



or suggestions proposed by DASA and that all the information 
reported to DASA was kept unclassified and publicly available. The 
work was also carried out by the University researchers with 
complete scientific freedom. 

In Section V it was stated that the procedures for informed 
consent followed by Dr. Saenger's partial and whole body radiation 
project reflected the process characteristic of the University of 
Cincinnati and the nation. As the idea of informed consent 
developed nationally in the 1960 's from informal, oral, and non- 
specific to formal, written, and more detailed. Dr. Saenger's 
project appropriately updated their procedure for informed consent 
to meet the more stringent levels required for good medical 
research. 

January 3, 1972 -- The ACR responded to Senator Mike Gravel's 
request to conduct an inquiry into the whole-body radiation therapy 
project supervised by Dr. Eugene L. Saenger . The ACR Report 
concluded that the Cincinnati project was validly conceived, 
stated, executed, controlled and followed up. The process of 
patient selection was based upon clinical considerations and 
conformed with good medical practice. The procedures for obtaining 
patient consent was valid and consistent with the recommendations 
of the National Institutes of Health and with the practice of most 
cancer centers. The ACR Report indicated procedures for obtaining 
informed consent were likely performed better than the average 
institution because of the volume of projects generated by the 
medical facility and the quality of the people involved. ACR urged 
Senator Gravel to support the projects continuation. The ACR 
Report also noted that DOD funds were used to support the 
laboratory and psychological studies, but not the treatment or the 
care of the patients. The ACR Report discusses at length the 
subject selection procedures and notes that in both race and IQ the 
group is representative of the patients served at Cincinnati 
General Hospital. The ACR Report also agreed with Dr. Saenger that 
". . . it seems reasonable to continue [whole-body radiation] 
therapy for the gravely ill individual since this method of 
treatment is less elaborate and with no greater risk than many 
present forms of chemotherapy." 

January 11, 1972 -- Senator Edward Kennedy wrote a letter to Dr. 
Warren Bennis in reference to the University's refusal to identify 
patients to be interviewed by the committee. The Senator pointed 
out that some patients appeared in a documentary produced by 
National Education Television in September, 1971, and it was 
difficult to understand why the University allowed them to appear 
on TV and not before a Senate Subcommittee. Senator Kennedy stated 
that the University's decision was unfortunate because "the most 
crucial element in the inquiry is the patient's perception and 
understanding of the experiments in which they were 
participating. . . " 

January 19, 1972 -- Dr. Edward A. Gall wrote a letter to Senator 
Kennedy responding to the Senator's January 11, 1972 letter. Dr. 



53 



Gall stated that names were provided to NET with the consent of the 
patients but points out that the situation had subsequently 
changed. In response to the Senator's request the University was 
sending letters to surviving patients to ask them if they would 
give their consent to being questioned by representatives of the 
subcommittee. He said that experts were consulted and they were of 
the opinion that any such questioning may have led to some 
unfavorable medical implications. Dr. Gall also asked the Senator 
if he would consent to a meeting with senior university officials. 

January 21, 1972 -- Mr. Ellis R. Mottur wrote a letter to Dr. 
Edward A. Gall requesting copies of the letter (with names omitted) 
sent to patients or parents of surviving patients asking if they 
would consent to interviews. 

January 25, 1972 -- Dr. Edward A. Gall wrote a letter to Mr. Ellis 
R. Mottur, Science Adviser, Senate Committee Labor Public Welfare, 
that forwarded the requested copies of letters sent to patients or 
parents to request interviews. 

February 4, 1972 -- In a letter to Dr. Robert W. McConnell Senator 
Mike Gravel indicated his displeasure with the results of the ACR 
Report released on January 3, 1972. Senator Gravel felt the report 
was deficient in relevant information and poorly organized. The 
Senator pointed out the ACR report "confirms that the patients were 
not thoroughly informed about the extra discomfort, the military 
aspects, or the possible lethal effects." 

February 4, 1972 --Mr. Myrton Tom Stewart and Mr. Robert Murphy of 
the General Accounting Officer (GAO) met with Dr. Eugene L. 
Saenger. Dr. Saenger was asked nine questions: when did the 
project start; did he approach DoD or vice versa [he approached]; 
how were parts of research funded; where were Federal funds used, 
etc. In response to question 4 which asked about the use of 
federal funds for patient care, Dr. Saenger replied that " [n] o DOD 
funds under these contracts were at any time used for payment of 
patient days in any hospital. DOD funds were used for technical 
help, support of a biochemist, physicians, physicists and for 
psychological and psychiatric studies." In response to question 6 
which asked if treatments were given for the benefit of the 
patients or DOD, Saenger responded, "that in all cases the 
treatment was given for the palliation of cancer of the patients 
and information for the Dod was a byproduct." 

February 16, 1972 -- Dr. Warren Bennis wrote a letter to Senator 
Kennedy referring to meeting with the Senator and Ohio Governor 
Gilligan on February 24, 1972. Dr. Bennis included a copy of the 
Ad Hoc Review Committee's report, and advised the Senator that Dr. 
Gall would be responding within a few days to the Senator's 
request for an evaluation of the report by the Junior Faculty 
Association. The letter concluded with the promise that he was 
willing to cooperate with the Subcommittee in any way consistent 
with the health and legal rights of the patients. 



54 



February 17, 1972 -- Dr. Edward A. Gall wrote a letter to Senator 
Edward Kennedy which provided a copy of the Ad Hoc Committee Report 
and other documentation. Regarding the Junior Faculty Report, Dr. 
Gall wrote that since the Ad Hoc Committee report addressed the 
points raised by the Junior Faculty Association he considered the 
Ad Hoc report "a complete and authoritative response." He also 
informed the Senator that they had received responses from all the 
surviving patients and the parents of the children treated 
regarding interviews. All responses had declined to be 
interviewed. Dr. Gall further expounded on the point made in his 
January 19, 1972 letter that two cancer experts (not local and not 
associated with the University) had given as their opinion that 
there would be unfavorable medical implications if patients were 
interviewed. 

February 17, 1972 -- Dr. Edward A. Gall wrote a letter to Dr. 
Warren Bennis forwarding the consultant opinions from the two 
cancer experts. Dr. Gall noted they were in concurrence with their 
own physicians about the undesirability of subjecting the patients 
to interviews. 

February 22, 1972 -- Mr. Cyril W. Kupferberg, Chair of Radiation 
Response Team, wrote a letter in response to an individual who 
requested to know if a family member was part of the experiment 
that was reported to DoD. The individual was not a subject of Dr. 
Saenger. The letter included attachments - University of 
Cincinnati Guideline for releasing medical information on deceased 
patients, an authorization for release of information form, and an 
example of a "Consent for Special Study and Treatment" form. 

March 31, 1972 -- The Cincinnati project contract number DASA-01- 
69C-0131 expired. The University of Cincinnati had earlier 
indicated that it did not want to continue conducting research 
under this contract with the Defense Nuclear Agency. 

July 5, 1972 -- Dr. Eugene L. Saenger wrote a letter to Dr. Edward 
A. Gall. The three page letter appears to be Dr. Saenger' s 
response to an article published in the Cincinnati Post on April 
25, 1972. Dr. Saenger' s response focuses on several points: 
University procedures for seeking Federal grants/contracts, issues 
associated with seeking DoD funds for research in FY 74 and the 
terminating of research utilizing FY 73 funds. 

August 1, 1972 -- Several pieces of correspondence relating to the 
Cincinnati project were entered into the Congressional Record, 
including a letter from the Comptroller General of the United 
States to Senator Edward Kennedy summarizing the results of the GAO 
investigation of DOD policy regarding the protection of humans used 
in medical research projects and DOD responses to questions from 
Senate staffers concerning DOD policy relative to human 
experimentation policies and procedures. The letter from the 
Comptroller General indicated that DOD policy was set forth by DOD 
Instruction 5030.29, dated May 12, 1964. Instruction 5030.29 
states that "The Department of Defense assumes full responsibility 



55 



for the protection of humans involved in research under its 
sponsorship whether this involves investigational drugs or other 
hazards." The letter also states, "[c]oncering the contract with 
the University of Cincinnati . . . [DNA] stated that the cost of 
radiation treatment and patient case had not been borne by their 
agency. They also stated that funds of the Defense Nuclear Agency 
had been used only to pay for supplementary laboratory analyses of 
patients who had received whole-body irradiation in order for the 
Defense Nuclear Agency to gain information in areas that were 
relative to national defense." 

The questions from Senate staffers focused on (1) the level of 
human experimentation funded by DOD, (2) what authorization was 
needed to conduct human experiments, (3) the adequacy of 
information given to prospective subjects and (4) were there 
differing standards applied to military personnel than to 
civilians. DOD responded to question one that only a very small 
portion of its medical R&D budget was given to human 
experimentation. In response to question two DOD stated that 
although there was no standardized authorization process, all human 
experimentation was guided by DOD instructions and service 
regulations and instructions. In response to question three DOD 
stated that informed consents was a primary ethical and legal 
requirements for all DOD use of human volunteers. In response to 
question four DOD responded that in terms of supervision, 
volunteering, informed consent and freedom to terminate there was 
no difference. 

January 11, 1973 -- Mr. Lawrence Elish released a 26 page paper 
titled, "Legal Rights of Human Subjects in the University of 
Cincinnati Whole-Body Radiation Study", that examined the legal and 
ethical implications of the Saenger experiments. 



56 



DEPARTMENT OF DEFENSE 
IMPLEMENTATION OF THE 
"COMMON RULE" - 
FEDERAL POLICY FOR THE 
PROTECTION OF HUMAN 
SUBJECTS 
32C.fr. PART 219 



§ 219.101 

PART 219— PROTECTION OF HUMAN 
SUBJEaS 

Sec. 

219.101 To what does this policy apply? 

219.102 Definitions. 

219.103 Assuring compliance with this 
policy— research conducted or supported 
by any Federal Department or Agency. 

219.104—219.106 [Reserved] 

219.107 IRB Membership. 

219.108 IRB functions and operations. 

219.109 IRB review of research. 

219.110 Expedited review procedures for 
certain kinds of research involving no 
more than minimal risk, and for minor 
changes in approved research. 

219.111 Criteria for IRB approval of re- 
search 

219.112 Review by institution. 

219.113 Suspension or termination of IRB 
approval of research. 

219.114 Cooperative research. 

219.115 IRB records. 

219.116 General requirements for informed 
consent. 

219.117 Documentation of informed con- 
sent. 

219.118 Applications and proposals laclung 
definite plans for involvement of human 
subjects. 

219.119 Research undertaken without the 
intention of involving human subjects. 

219.120 Evaluation and disposition of ap- 
plications and proposals for research to 
be conducted or supported by a Federal 
Department or Agency. 

219.121 [Reserved] 

219.122 Use of Federal funds. 

219.123 Early termmation of research sup- 
port: Evaluation of applications and pro- 
posals. 

219.124 Conditions. 

Authority: 5 U.S.C. 301: 42 U.S.C. 300v- 
1(b). 

SoimcE: 56 FR 28012. 28021. June 18. 1991. 
unless otherwise noted. 

§219.101 To what does this policy apply? 

(a) Except as provided in paragraph 
(b) of this section, this policy applies 
to all research involving human sub- 
jects conducted, supported or other- 
wise subject to regulation by any fed- 
eral department or agency which takes 
appropriate administrative action to 
make the policy applicable to such re- 
search. This Includes research con- 
ducted by federal civilian employees or 
military personnel, except that each 
department or agency head may adopt 
such procedural modifications as may 



289 



57 



§219.101 

be appropriate from an administrative 
standpoint. It also includes research 
conducted, supported, or otherwise 
subject to regulation by the federsil 
government outside the United States. 

(1) Research that is conducted or 
supported by a federal department or 
agency, whether or not it is regulated 
as defined in S 219.102(e), must comply 
with all sections of this policy. 

(2) Research that is neither conduct- 
ed nor supported by a federal depart- 
ment or agency but is subject to regu- 
lation as defined in § 219.102(e) must 
be reviewed and approved, in compli- 
ance with § 219.101, § 219.102, and 
§219.107 through §219.117 of this 
policy, by an institutional review 
board (IRB) that operates in accord- 
ance with the pertinent requirements 
of this policy. 

(b) Unless otherwise required by de- 
partment or agency heads, research 
activities in which the only involve- 
ment of human subjects will be in one 
or more of the following categories are 
exempt from this policy: 

(1) Research conducted in estab- 
lished or commonly accepted educa- 
tional settings, involving normal edu- 
cational practices, such as (i) research 
on regular and special education in- 
structional strategies, or (ii) research 
on the effectiveness of or the compari- 
son among instructional techniques, 
curricula, or classroom management 
methods. 

(2) Research involving the use of 
educational tests (cognitive, diagnos- 
tic, aptitude, achievement), survey 
procedures, interview procedures or 
observation of public behavior, unless: 

(i) Information obtained is recorded 
in such a manner that human subjects 
can be identified, directly or through 
identifiers linked to the subjects: and 
(ii) any disclosure of the human sub- 
jects' responses outside the research 
could reasonably place the subjects at 
risk of criminal or civil liability or be 
damaging to the subjects' financial 
standing, employability. or reputation. 

(3) Research involving the use of 
educational tests (cognitive, diagnos- 
tic, aptitude, achievement), survey 
procedures, interview procedures, or 
observation of public behavior that is 
not exempt under paragraph (b)(2) of 
this section, if: 



32 CFR Ch. I (7-1-93 Edition) 

(i) The human subjects are elected 
or appointed public officials or candi- 
dates for public office; or (11) federal 
statute(s) require(s) without exception 
that the confidentiality of the person- 
ally identifiable information will be 
maintained throughout the research 
and thereafter. 

(4) Research, involving the collec- 
tion or study of existing data, docu- 
ments, records, pathological speci- 
mens, or diagnostic specimens, if these 
sources are publicly available or if the 
information is recorded by the investi- 
gator in such a manner that subjects 
cannot be identified, directly or 
through identifiers linked to the sub- 
jects. 

(5) Research and demonstration 
projects which are conducted by or 
subject to the approval of department 
or agency heads, and which are de- 
signed to study, evaluate, or otherwise 
examine: 

(1) Public benefit or service pro- 
grams: (ii) procedures for obtaining 
benefits or services under those pro- 
grams; (iii) possible changes in or al- 
ternatives to those programs or proce- 
dures; or (iv) possible changes in meth- 
ods or levels of payment for benefits 
or services under those programs. 

(6) Taste and food quality evaluation 
and consiuner acceptance studies, (1) if 
wholesome foods without additives are 
consumed or (ii) if a food is consumed 
that contains a food ingredient at or 
below the level and for a use found to 
be safe, or agricultural chemical or en- 
vironmental contaminant at or below 
the level found to be safe, by the Pood 
and Drug Administration or approved 
by the Environmental Protection 
Agency or the Pood Safety and Inspec- 
tion Service of the U.S. Department of 
Agriculture. 

(c) Department or agency heads 
retain final judgment as to whether a 
particular activity is covered by this 
policy. 

(d) Department or agency heads 
may require that specific research ac- 
tivities or classes of research activities 
conducted, supported, or otherwise 
subject to regulation by the depart- 
ment or agency but not otherwise cov- 
ered by this policy, comply with some 
or all of the requirements of this 
policy. 



290 



58 



Offic* of the Secretary of Defense 

(e) Compliance with this policy re- 
quires compliance with pertinent fed- 
eral laws or regvilations which provide 
additional protections for human sub- 
jects. 

(f) This policy does not affect any 
state or local laws or regulations 
which may otherwise be applicable 
and which provide additional protec- 
tions for human subjects. 

(g) This policy does not affect any 
foreign laws or regulations which may 
otherwise be applicable and which 
provide additional protections to 
human subjects of research. 

(h) When research covered by this 
policy takes place in foreign countries, 
procedures normally followed in the 
foreign countries to protect human 
subjects may differ from those set 
forth in this policy. [An example is a 
foreign institution which complies 
with guidelines consistent with the 
World Medical Assembly Declaration 
(Declaration of Helsinki amended 
1989) issued either by sovereign states 
or by an organization whose function 
for the protection of human research 
subjects is internationally recognized.] 
In these circumstances, if a depart- 
ment or agency head determines that 
the procedures prescribed by the insti- 
tution afford protections that are at 
least equivalent to those provided in 
this policy, the department or agency 
head may approve the substitution of 
the foreign procedures in lieu of the 
procedural requirements provided in 
this policy. Except when otherwise re- 
quired by statute. Executive Order, or 
the department or agency head, no- 
tices of these actions as they occur will 
be published in the Federal Register 
or will be otherwise published as pro- 
vided in department or agency proce- 
dures. 

(i) Unless otherwise required by law, 
department or agency heads may 
waive the applicability of some or all 
of the provisions of this policy to spe- 
cific research activities or classes of re- 
search activities otherwise covered by 
this policy. Except when otherwise re- 
quired by statute or Executive Order, 
the department or agency head shall 
forward advance notices of these ac- 
tions to the Office for Protection from 
Research Risks, Department of Health 
and Human Services (HHS), and shall 



§219.102 

also publish them in the Federal Reg- 
ister or in such other manner as pro- 
vided in department or agency proce- 
dures.' 

[56 FR 28012, 28021. June 18. 1991. as 
amended at 56 FR 29756, June 28, 19911 

§ 219.102 Definitions. 

(a) Department or agency head 
means the head of any federal depart- 
ment or agency and any other officer 
or employee of any department or 
agency to whom authority has been 
delegated. 

(b) Institution means any public or 
private entity or agency (including 
federal, state, and other agencies). 

(c) Legally authorized representative 
means an individual or judicial or 
other body authorized under applica- 
ble law to consent on behalf of a pro- 
spective subject to the subject's par- 
ticipation in the procedure(s) involved 
in the research. 

(d) Research means a systematic in- 
vestigation, including research devel- 
opment, testing and evaluation, de- 
signed to develop or contribute to gen- 
eralizable knowledge. Activities which 
meet this definition constitute re- 
search for purposes of this policy, 
whether or not they are conducted or 
supported under a program which is 
considered research for other pur- 
poses. For example, some demonstra- 
tion and service programs may include 
research activities. 

(e) Research subject to regulation, 
and similar terms are intended to en- 
compass those research activities for 
which a federal department or agency 



' Institutions with HHS-approved assur- 
ances on file will abide by provisions of title 
45 CFR part 46 subparts A-D. Some of the 
other Departments and Agencies have in- 
corporated all provisions of title 45 CFR 
part 46 into their policies and procedures as 
well. However, the exemptions at 45 CFR 
46.101(b) do not apply to research involving 
prisoners, fetuses, pregnant women, or 
human in vitro fertilization, subparts B and 
C. The exemption at 45 CFR 46.101(b)(2), 
for research involving survey or interview 
procedures or observation of public behav- 
ior, does not apply to research with chil- 
dren, subpart D. except for research involv- 
ing observations of public behavior when 
the investigators) do not participate in the 
activities being observed. 



291 



59 



§219.103 

has specific responsibility for regulat- 
ing as a research activity, (for exam- 
ple. Investigational New Drug require- 
ments administered by the Pood and 
Drug Administration). It does not in- 
clude research activities which are in- 
cidentally regulated by a federal de- 
partment or agency solely as part of 
the department's or agency's broader 
responsibility to regulate certain types 
of activities wnether research or non- 
research in nature (for example, Wage 
and Hour requirements administered 
by the Department of Labor). 

(f) Human subject means a living in- 
dividual about whom an investigator 
(whether professional or student) con- 
ducting research obtains 

(1) Data through intervention or 
interaction with the individual, or 

(2) Identifiable private information. 
Intervention includes both physical 
procedures by which data are gathered 
(for example, venipuncture) and ma- 
nipulations of the subject or the sub- 
ject's environment that are performed 
for research purposes. Interaction in- 
cludes communication or interpersonal 
contact between investigator and sub- 
ject. "Private information" includes 
information about behavior that 
occurs in a context in which an indi- 
vidual can reasonably expect that no 
observation or recording is taking 
place, and information which has been 
provided for specific purposes by an 
individual and which the individual 
can reasonably expect will not be 
made public (for example, a medical 
record). Private information must be 
individually identifiable (i.e., the iden- 
tity of the subject is or may readily be 
ascertained by the investigator or as- 
sociated with the information) in 
order for obtaining the information to 
constitute research involving human 
subjects. 

(g) IRB means an institutional 
review board established in accord 
with and for the purposes expressed in 
this policy. 

(h) IRB approval means the deter- 
mination of the IRB that the research 
has been reviewed and may be con- 
ducted at an institution within the 
constraints set forth by the IRB and 
by other institutional and federal re- 
quirements. 



32 CFR Ch. I (7-1.93 Edition) 

(i) Minimal risk means that the 
probability and magnitude of harm or 
discomfort anticipated in the research 
are not greater in and of themselves 
than those ordinarily encountered in 
daily life or during the performance of 
routine physical or psychological ex- 
aminations or tests. 

(j) Certification means the official 
notification by the institution to the 
supporting department or agency, in 
accordance with the requirements of 
this policy, that a research project or 
activity involving hiunan subjects has 
been -eviewed and approved by an 
IRB in accordance with an approved 
assurance. 

§219.103 Assuring compliance with this 
policy— research conducted or support- 
ed by any Federal Department or 
Agency. 

(a) Each institution engaged in re- 
search which is covered by this policy 
and which is conducted or supported 
by a federal department or agency 
shall provide written assurance satis- 
factory to the department or agency 
head that it will comply with the re- 
quirements set forth in this policy. In 
lieu of requiring submission of an as- 
surance, individual department or 
agency heads shall accept the exist- 
ence of a current assurance, appropri- 
ate for the research in question, on 
file with the Office for Protection 
from Research Risks, HHS, and ap- 
proved for federalwide use by that 
office. When the existence of an HHS- 
approved assurance is accepted in lieu 
of requiring submission of an assur- 
ance, reports (except certification) re- 
quired by this policy to be made to de- 
partment and agency heads shall also 
be made to the Office for Protection 
from Research Risks, HHS. 

(b) Departments and agencies will 
conduct or support research covered 
by this policy only if the institution 
has an assurance approved as provided 
in this section, and only if the institu- 
tion has certified to the department or 
agency head that the research has 
been reviewed and approved by an 
IRB provided for in the assurance, and 
will be subject to continuing review by 
the IRB. Assurances applicable to fed- 



292 



60 



Office of the Secretary of Defense 

erally supported or conducted re- 
search shall at a minimum include: 

(DA statement of principles govern- 
ing the institution in the discharge of 
its responsibilities for protecting the 
rights and welfare of human subjects 
of research conducted at or sponsored 
by the institution, regardless of 
whether the research is subject to fed- 
eral regulation. This may include an 
appropriate existing code, declaration, 
or statement of ethical principles, or a 
statement formulated by the institu- 
tion itself. This requirement does not 
preempt provisions of this policy ap- 
plicable to department- or agency-sup- 
ported or regulated research and need 
not be applicable to any research ex- 
empted or waived under § 219.101 (b) 
or (i). 

(2) Designation of one or more IRBs 
established in accordance with the re- 
quirements of this policy, and for 
which provisions are made for meeting 
space and sufficient staff to support 
the IRB's review and recordkeeping 
duties. 

(3) A list of IRB members identified 
by name: earned degrees: representa- 
tive capacity; indications of experience 
such as board certifications, licenses, 
etc., sufficient to describe each mem- 
ber's chief anticipated contributions to 
IRB deliberations; and any employ- 
ment or other relationship between 
each member and the institution; for 
example: full-time employee, part-time 
employee, member of governing panel 
or board, stockholder, paid or unpaid 
consultant. Changes in IRB member- 
ship shall be reported to the depart- 
ment or agency head, unless in accord 
with § 219.103(a) of this policy, the ex- 
istence of an HHS-approved assurance 
is accepted. In this case, change in 
IRB membership shall be reported to 
the Office for Protection from Re- 
search Risks, HHS. 

(4) Written procedures which the 
IRB will follow (i) for conducting its 
initial and continuing review of re- 
search and for reporting its findings 
and actions to the investigator and the 
institution; (ii) for determining which 
projects require review more often 
than annually and which projects 
need verification from sources other 
than the investigators that no materi- 
al changes have occurred since previ- 



§219.103 

ous IRB review; and (iii) for ensuring 
prompt reporting to the IRB of pro- 
posed changes in a research activity, 
and for ensuring that such changes in 
approved research, during the period 
for which IRB approval has already 
been given, may not be initiated with- 
out IRB review and approval except 
when necessary to eliminate apparent 
immediate hazards to the subject. 

(5) Written procedures for ensuring 
prompt reporting to the IRB, appro- 
priate institutional officials, and the 
department or agency head of (i) any 
unanticipated problems involving risks 
to subjects or others or any serious or 
continuing noncompliance with this 
policy or the requirements or determi- 
nations of the IRB and (ii) any sus- 
pension or termination of IRB approv- 
al. 

(c) The assurance shall be executed 
by an individual authorized to act for 
the institution and to assume on 
behalf of the institution the obliga- 
tions imposed by this policy and shall 
be filed in such form and manner as 
the department or agency head pre- 
scribes. 

(d) The department or agency head 
will evaluate all assurances submitted 
in accordance with this policy through 
such officers and employees of the de- 
partment or agency and such experts 
or consultants engaged for this pur- 
pose as the department or agency 
head determines to be appropriate. 
The department or agency head's eval- 
uation will take into consideration the 
adequacy of the proposed IRB in light 
of the anticipated scope of the institu- 
tion's research activities and the types 
of subject populations likely to be in- 
volved, the appropriateness of the pro- 
posed initial and continuing review 
procedures in light of the probable 
risks, and the size and complexity of 
the institution. 

(e) On the basis of this evaluation, 
the department or agency head may 
approve or disapprove the assurance, 
or enter into negotiations to develop 
an approvable one. The department or 
agency head may limit the period 
during which any particular approved 
assurance or class of approved assur- 
ances shall remain effective or other- 
wise condition or restrict approval. 



293 



61 



§219.107 

(f ) Certification is required when the 
research is supported by a federal de- 
partment or agency and not otherwise 
exempted or waived under § 219.101 
(b) or (i). An institution with an ap- 
proved assurance shall certify that 
each application or proposal for re- 
search covered by the assurance and 
by § 219.103 of this Policy has been re- 
viewed and approved by the IRB. Such 
certification must be submitted with 
the application or proposal or by such 
later date as may be prescribed by the 
department or agency to which the ap- 
plication or proposal is submitted. 
Under no condition shaU research cov- 
ered by § 219.103 of the Policy be sup- 
ported prior to receipt of the certifica- 
tion that the research has been re- 
viewed and approved by the IRB. In- 
stitutions without an approved assur- 
ance covering the research shall certi- 
fy within 30 days after receipt of a re- 
quest for such a certification from the 
department or agency, that the appli- 
cation or proposal has been approved 
by the IRB. If the certification is not 
submitted within these time limits, 
the application or proposal may be re- 
turned to the institution. 

(Approved by the Office of Management 
and Budget under control number 9999- 
0020) 

[56 FR 28012. 28021, June 18. 1991. as 
amended at 56 FR 29756, June 28, 1991] 

§§219.104—219.106 [Reserved] 

§ 219.107 IRB membership. 

(a) Each IRB shall have at least five 
members, with varying backgrounds to 
promote complete and adequate 
review of research activities commonly 
conducted by the institution. The IRB 
shall be sufficiently qualified through 
the experience and expertise of its 
members, and the diversity of the 
members, including consideration of 
race, gender, and cultural backgrounds 
and sensitivity to such issues as com- 
munity attitudes, to promote respect 
for its advice and counsel in safeguard- 
ing the rights and welfare of human 
subjects. In addition to possessing the 
professional competence necessary to 
review specific research activities, the 
IRB shall be able to ascertain the ac- 
ceptability of proposed research in 
terms of institutional commitments 



32 CFR Ch. I (7.1-93 Edition) 

and regulations, applicable law. and 
standards of professional conduct and 
practice. The IRB shall therefore in- 
clude persons knowledgeable in these 
areas. If an IRB regularly reviews re- 
search that involves a vulnerable cate- 
gory of subjects, such as children, pris- 
oners, pregnant women, or handi- 
capped or mentally disabled persons, 
consideration shall be given to the in- 
clusion of one or more individuals who 
are knowledgeable about and experi- 
enced in working with these subjects. 

(b) Every nondiscriminatory effort 
will be made to ensure that no IRB 
consists entirely of men or entirely of 
women, including the institution's con- 
sideration of qualified persons of both 
sexes, so long as no selec-ion is made 
to the IRB on the basis l. gender. No 
IRB may consist entirely of members 
of one profession. 

(c) Each IRB shall include at least 
one member whose primary concerns 
are in scientific areas and at least one 
member whose primary concerns are 
in nonscientif ic areas. 

(d) Each IRB shall include at least 
one member who is not otherwise af- 
filiated with the institution and who is 
not part of the immediate family of a 
person who is affiliated with the insti- 
tution. 

(e) No IRB may have a member par- 
ticipate in the IRB's initial or continu- 
ing review of any project in which the 
member has a conflicting interest, 
except to provide information request- 
ed by the IRB. 

(f) An IRB may, in its discretion, 
invite individuals with competence in 
special areas to assist in the review of 
issues which require expertise beyond 
or in addition to that available on the 
IRB. These individuals may not vote 
with the IRB. 

§ 219.108 IRB functions and operations. 

In order to fulfUl the requirements 
of this policy each IRB shall: 

(a) Follow written procedures in the 
same detail as described in 
§ 219.103(bX4) and. to the extent re- 
quired by. § 219.103(b)(5). 

(b) Except when an expedited review 
procedure is used (see §219.110), 
review proposed research at convened 
meetings at which a majority of the 



294 



62 



Office of the Secretary of Defense 

members of the IRB are present, in- 
cluding at least one member whose 
prirciary concerns are in nonscientific 
areas. In order for the research to be 
approved, it shall receive the approval 
of a majority of those members 
present at the meeting. 

§ 219.109 IRB Review of Research. 

(a) An IRB shall review and have au- 
thority to approve, require modifica- 
tions in (to secure approval), or disap- 
prove all research activities covered by 
this policy. 

(b) An IRB shall require that infor- 
mation given to subjects as part of in- 
formed consent is in accordance with 
§ 219.116. The IRB may require that 
information, in addition to that specif- 
ically mentioned in § 219.116, be given 
to the subjects when in the IRB's 
judgment the information would 
meaningfully add to the protection of 
the rights and welfare of subjects. 

(c) An IRB shall require documenta- 
tion of informed consent or may waive 
documentation in accordance with 
§219.117. 

(d) An IRB shsill notify investigators 
and the institution in writing of its de- 
cision to approve or disapprove the 
proposed research activity, or of modi- 
fications required to secure IRB ap- 
proval of the research activity. If the 
IRB decides to disapprove a research 
activity, it shall Include in its written 
notification a statement of the reasons 
for its decision and give the Investiga- 
tor an opportunity to respond In 
person or in writing. 

(e) An IRB shall conduct continuing 
review of research covered by this 
policy at Intervals appropriate to the 
degree of risk, but not less than once 
per year, and shall have authority to 
observe or have a third party observe 
the consent process and the research. 

(Approved by the Office of Management 
and Budget under control number 9999- 
0020) 

§219.110 Expedited review procedures for 
certain kinds of research involving no 
more than minimal risk, and for minor 
changes in approved research. 

(a) The Secretary, HHS, has estab- 
lished, and published as a Notice in 
the Federal Register, a list of catego- 
ries of research that may be reviewed 



§219.111 

by the IRB through an expedited 
review procedure. The list will be 
amended, as appropriate after consul- 
tation with other departments and 
agencies, through periodic republica- 
tion by the Secretary, HHS, in the 
Federal Register. A copy of the list is 
available from the Office for Protec- 
tion from Research Risks, National In- 
stitutes of Health, HHS, Bethesda, 
Maryland 20892. 

(b) An IRB may use the expedited 
review procedure to review either or 
both of the following: 

(1) Some or all of the research ap- 
pearing on the list and found by the 
reviewer(s) to involve no more than 
minimal risk, 

(2) Minor changes in previously ap- 
proved research during the period (of 
one year or less) for which approval is 
authorized. 

Under an expedited review procedure, 
the review may be carried out by the 
IRB chairperson or by one or more ex- 
perienced reviewers designated by the 
chairperson from among members of 
the IRB. In reviewing the research, 
the reviewers may exercise aU of the 
authorities of the IRB except that the 
reviewers may not disapprove the re- 
search. A research activity may be dis- 
approved only after review in accord- 
ance with the non-expedited proce- 
dure set forth in § 219.108(b). 

(c) Each IRB which uses an expedit- 
ed review procedure shall adopt a 
method for keeping all members ad- 
vised of research proposals which have 
been approved under the procedure. 

(d) The department or agency head 
Tiay restrict, suspend, terminate, or 
choose not to authorize an institu- 
tion's or IRB's use of the expedited 
review procedure. 

§219.111 Criteria for IRB approval of re- 
search. 

(a) In order to approve research cov- 
ered by this policy the IRB shall de- 
termine that all of the following re- 
quirements are satisfied: 

(1) Risks to subjects are minimized: 
(i) By using procedures which are con- 
sistent with sound research design and 
which do not unnecessarily exi>ose 
subjects to risk, and (11) whenever ap- 
propriate, by using procedures tdready 



295 



63 



§219.112 

being performed on the subjects for 
diagnostic or treatment purposes. 

(2) Risks to subjects are reasonable 
in relation to anticipated benefits, if 
any. to subjects, and the importance 
of the knowledge that may reasonably 
be expected to result. In evaluating 
risks and benefits, the IRB should 
consider only those risks and benefits 
that may result from the research (as 
distinguished from risks and benefits 
of therapies subjects would receive 
even if not participating in the re- 
search). The IRB should not consider 
possible long-range effects of applying 
knowledge gained in the research (for 
example, the possible effects of the re- 
search on public policy) as among 
those research risks that fall within 
the purview of its responsibility. 

(3) Selection of subjects is equitable. 
In making this assessment the IRB 
should take into account the purposes 
of the research and the setting in 
which the research will be conducted 
and should be particularly cognizant 
of the special problems of research in- 
volving vulnerable populations, such 
as children, prisoners, pregnant 
women, mentally disabled persons, or 
economically or educationally disad- 
vantaged persons. 

(4) Informed consent will be sought 
from each prospective subject or the 
subject's legally authorized represent- 
ative, in accordance with, and to the 
extent required by § 219.116. 

(5) Informed consent will be appro- 
priately documented, in accordance 
with, and to the extent required by 
§219.117. 

(6) When appropriate, the research 
plan makes adequate provision for 
monitoring the data collected to 
ensure the safety of subjects. 

(7) When appropriate, there are ade- 
quate provisions to protect the privacy 
of subjects and to maintain the confi- 
dentiality of data. 

(b) When some or all of the subjects 
are likely to be vulnerable to coercion 
or undue influence, such as children, 
prisoners, pregnant women, mentally 
disabled persons, or economically or 
educationally disadvantaged persons, 
additional safeguards have been in- 
cluded in the study to protect the 
rights and welfare of these subjects. 



32 CFR Ch. I (7-1-93 Edition) 

§ 219.112 Review by institution. 

Research covered by this policy that 
has been approved by an IRB may be 
subject to further appropriate review 
and approval or disapproval by offi- 
cials of the institution. However, those 
officials may not approve the research 
if it has not been approved by an IRB. 

§219.113 Suspension or termination of 
IRB approval of research. 

An IRB shall have authority to sus- 
pend or terminate approval of re- 
search that is not being conducted in 
accordance with the IRB's require- 
ments or that has been associated with 
unexpected serious harm to subjects. 
Any suspension or termination of ap- 
proval shall include a statement of the 
reasons for the IRB's action and shall 
be reported promptly to the investiga- 
tor, appropriate institutional officials, 
and the department or agency head. 

(Approved by the Office of Management 
and Budget under control number 9999- 
0020) 

§219.114 Cooperative research. 

Cooperative research projects are 
those projects covered by this policy 
which involve more than one institu- 
tion. In the conduct of cooperative re- 
search projects, each institution is re- 
sponsible for safeguarding the rights 
and welfare of human subjects and for 
complying with this policy. With the 
approval of the department or agency 
head, an institution participating in a 
cooperative project may enter into a 
joint review arrangement, rely upon 
the review of another qualified IRB, 
or make similar arrangements for 
avoiding duplication of effort. 

§219.115 IRB records. 

(a) An institution, or when appropri- 
ate an IRB, shall prepare and main- 
tain adequate documentation of IRB 
activities, including the following: 

(1) Copies of all research proposals 
reviewed, scientific evaluations, if any. 
that accompany the proposals, ap- 
proved sample consent documents, 
progress reports submitted by investi- 
gators, and reports of injuries to sub- 
jects. 

(2) Minutes of IRB meetings which 
shall be in sufficient detail to show at- 



296 



64 



Office of th« Secretary of Defense 

tendance at the meetings; actions 
taken by the IRB; the vote on these 
actions including the number of mem- 
bers voting for. against, and abstain- 
ing: the basis for requiring changes in 
or disapproving research; and a writ- 
ten summary of the discussion of con- 
troverted issues and their resolution. 

(3) Records of continuing review ac- 
tivities. 

(4) Copies of all correspondence be- 
tween the IRB and the investigators. 

(5) A list of IRB members in the 
same detail as described is 
§ 219.103(b)(3). 

(6) Written procedures for the IRB 
in the same detail as described in 
§ 219.103(b)(4) and § 219.103(b)(5). 

(7) Statements of significant new 
findings provided to subjects, as re- 
quired by § 219.116(b)(5). 

(b) The records required by this 
policy shall be retained for at least 3 
years, and records relating to research 
which is conducted shall be retained 
for at least 3 years after completion of 
the research. All records shall be ac- 
cessible for inspection and copjong by 
authorized representatives of the de- 
partment or agency at reasonable 
times and in a reasonable manner. 

(Approved by the Office of Management 
and Budget under control number 9999- 
0020) 

§219.116 General requirements for in- 
formed consent. 

Except as provided elsewhere in this 
policy, no investigator may involve a 
human being as a subject in research 
covered by this policy unless the inves- 
tigator has obtained the legally effec- 
tive informed consent of the subject or 
the subject's legally authorized repre- 
sentative. An investigator shall seek 
such consent only under circum- 
stances that provide the prospective 
subject or the representative sufficient 
opportunity to consider whether or 
not to participate and that minimi2% 
the possibility of coercion or undue in- 
fluence. The information that is given 
to the subject or the representative 
shall be in language understandable to 
the subject or the representative. No 
informed consent, whether oral or 
written, may include any exculpatory 
language through which the subject 
or the representative is made to waive 



§219.116 

or appear to waive any of the subject's 
legal rights, or releases or appears to 
release the investigator, the sponsor, 
the institution or its agents from li- 
ability for negligence. 

(a) Basic elements of informed con- 
sent. Except as provided in paragraph 
(c) or (d) of this section, in seeking in- 
formed consent the following informa- 
tion shall be provided to each subject: 

(DA statement that the study in- 
volves research, an explanation of the 
purposes of the research and the ex- 
pected duration of the subject's par- 
ticipation, a description of the proce- 
dures to be followed, and identifica- 
tion of any procedures which are ex- 
perimental; 

(2) A description of any reasonably 
foreseeable risks or discomforts to the 
subject: 

(3) A description of any benefits to 
the subject or to others which may 
reasonably be expected from the re- 
search; 

(4) A disclosure of appropriate alter- 
native procedures or courses of treat- 
ment, if any, that might be advanta- 
geous to the subject; 

(5) A statement describing the 
extent, if any. to which confidentiality 
of records identifying the subject will 
be maintained; 

(6) For research involving more than 
minimal risk, an explanation as to 
whether any compensation and an ex- 
planation as to whether any medical 
treatments are available if injury 
occurs and, if so, what they consist of, 
or where fvu^her information may be 
obtained; 

(7) An explanation of whom to con- 
tact for answers to pertinent questions 
about the research and research sub- 
jects' rights, and whom to contact in 
the event of a research-related injury 
to the subject; and 

(8) A statement that participation is 
voluntary, refusal to participate will 
involve no penalty or loss of benefits 
to which the subject is otherwise enti- 
tled, and the subject may discontinue 
participation at any time without pen- 
alty or loss of benefits to which the 
subject is otherwise entitled. 

(b) Additional elements of informed 
consent. When appropriate, one or 
more of the following elements of in- 



297 



65 



§219.117 

formation shall also be provided to 
each subject: 

(DA statement that the particular 
treatment or procedure may involve 
risks to the subject (or to the embryo 
or fetus, if the subject is or may 
become pregnant) which are currently 
unforeseeable; 

(2) Anticipated circumstances under 
which the subject's participation may 
be terminated by the investigator 
without regard to the subject's con- 
sent: 

(3) Any additional costs to the sub- 
ject that may result from participa- 
tion in the research; 

(4) The consequences of a subject's 
decision to withdraw from the re- 
search and procedures for orderly ter- 
mination of participation by the sub- 
ject; 

(5) A statement that significant new 
findings developed during the course 
of the research which may relate to 
the subject's willingness to continue 
participation will be provided to the 
subject; and 

(6) The approximate number of sub- 
jects involved in the study. 

(c) An IRB may approve a consent 
procedure which does not include, or 
which alters, some or all of the ele- 
ments of informed consent set forth 
above, or waive the requirement to 
obtain informed consent provided the 
IRB finds and documents that: 

(1) The research or demonstration 
project is to be conducted by or sub- 
ject to the approval of state or local 
government officials and is designed to 
study, evaluate, or otherwise examine: 
(i) Public benefit of service programs; 
(ii) procedures for obtaining benefits 
or services under those programs; (iii) 
possible changes in or alternatives to 
those programs or procedures; or (iv) 
possible changes in methods or levels 
of payment for benefits or services 
imder those programs; and 

(2) The research could not practica- 
bly be carried out without the waiver 
or alteration. 

(d) An IRB may approve a consent 
procedure which does not include, or 
which alters, some or all of the ele- 
ments of informed consent set forth in 
this section, or waive the requirements 
to obtain informed consent provided 
the IRB finds and documents that: 



32 CFR Ch. I (7-1-93 Edition) 

(1) The research involves no more 
than minimal risk to the subjects; 

(2) The waiver or alteration will not 
adversely affect the rights and welfare 
of the subjects; 

(3) The research could not practica- 
bly be carried out without the waiver 
or alteration; and 

(4) Whenever appropriate, the sub- 
jects will be provided with additional 
pertinent information after participa- 
tion. 

(e) The informed consent require- 
ments in this policy are not intended 
to preempt any applicable federal, 
state, or local laws which require addi- 
tional information to be disclosed in 
order for informed consent to be legal- 
ly effective. 

(f) Nothing in this policy is intended 
to limit the authority of a physician to 
provide emergency medical care, to 
the extent the physician is permitted 
to do so under applicable federal, 
state, or local law. 

(Approved by the Office of Management 
and Budget under control number 9999- 
0020) 

§ 219.117 Documentation of informed con- 
sent. 

(a) Except as provided in paragraph 
(c) of this section, informed consent 
shall be documented by the use of a 
written consent form approved by the 
IRB and signed by the subject or the 
subject's legally authorized represent- 
ative. A copy shall be given to the 
person signing the form. 

(b) Except as provided in paragraph 
(c) of this section, the consent form 
may be either of the following: 

(DA written consent document that 
embodies the elements of informed 
consent required by §219.116. This 
form may be read to the subject or the 
subject's legally authorized represent- 
ative, but in any event, the investiga- 
tor shall give either the subject or the 
representative adequate opportunity 
to read it before it is signed; or 

(2) A short form written consent 
document stating that the elements of 
informed consent required by § 219.116 
have been presented orally to the sub- 
ject or the subject's legally authorized 
representative. When this method is 
used, there shall be a witness to the 



298 



66 



Offic* of the Socretary of Dofonso 

oral presentation. Also, the IRB shall 
approve a written summary of what is 
to be said to the subject or the repre- 
sentative. Only the short form itself is 
to be signed by the subject or the rep- 
resentative. However, the witness shall 
sign both the short form and a copy of 
the summary, and the person actually 
obtaining consent shall sign a copy of 
the summary. A copy of the summary 
shall be given to the subject or the 
representative, in addition to a copy of 
the short form. 

(c) An IRB may waive the require- 
ment for the investigator to obtain a 
signed consent form for some or all 
subjects if it finds either: 

(1) That the only record linldng the 
subject and the research would be the 
consent docimient and the principal 
risk would be potential harm resulting 
from a breach of confidentiality. Each 
subject will be asked whether the sub- 
ject wants documentation linking the 
subject with the research, and the sub- 
ject's wishes will govern; or 

(2) That the research presents no 
more than minimal risk of harm to 
subjects and involves no procedures 
for which written consent is normally 
required outside of the research con- 
text. 

In cases in which the documentation 
requirement is waived, the IRB may 
require the investigator to provide 
subjects with a written statement re- 
garding the research. 

(Approved by the Office of Management 
and Budget under control number 9999- 
0020) 

§219.118 Applications and proposals lack- 
ing deHnite plans for involvement of 
human subjecu. 

Certain types of applications for 
grants, cooperative agreements, or 
contracts are submitted to depart- 
ments or agencies with the knowledge 
that subjects may be involved within 
the period of support, but definite 
plans would not normally be set forth 
in the application or proposal. These 
include activities such as institutional 
type grants when selection of specific 
projects is the institution's responsibil- 
ity: research training grants in which 
the activities involving subjects remain 
to be selected; and projects in which 
himian subjects' involvement will 



§219.120 

depend upon completion of instru- 
ments, prior animal studies, or purifi- 
cation of compoimds. These applica- 
tions need not be reviewed by an IRB 
before an award may be made. Howev- 
er, except for research exempted or 
waived under S 219.101 (b) or (i), no 
human subjects may be involved in 
any project supported by these awards 
until the project has been reviewed 
and approved by the IRB, as provided 
in this policy, and certification submit- 
ted, by the institution, to the depart- 
ment or agency. 

§219.119 Research undertaken without 
the intention of involving human sub- 
jects. 

In the event research is imdertaken 
without the intention of involving 
human subjects, but it is later pro- 
posed to involve himian subjects in the 
research, the research shall first be re- 
viewed and approved by an IRB, as 
provided in this policy, a certification 
submitted, by the institution, to the 
department or agency, and final ap- 
proval given to the proposed change 
by the department or agency. 

§219.120 Evaluation and disposition of 
applications and proposals for research 
to be conducted or supported by a Fed- 
eral Department or Agency. 

(a) The department or agency head 
will evaluate all apolications and pro- 
posals involving human subjects sub- 
mitted to the department or agency 
through such officers and employees 
of the department or agency and such 
experts and consultants as the depart- 
ment or agency head determines to be 
appropriate. This evaluation will take 
into consideration the rislts to the sub- 
jects, the adequacy of protection 
against these risks, the potential bene- 
fits of the research to the subjects and 
others, and the Importance of the 
knowledge gained or to be gained. 

(b) On the basis of this evaluation, 
the department or agency head may 
approve or disapprove the application 
or proposal, or enter into negotiations 
to develop an approvable one. 



299 



67 



§219.122 

§219.121 [Reserved] 

§ 219.122 Use of Federal funds. 

Federal funds administered by a de- 
partment or agency may not be ex- 
pended for research involving human 
subjects imless the requirements of 
this policy have been satisfied. 

§ 219.123 Early termination of research 
support: Evaluation of applications 
and proposals. 

(a) The department or agency head 
may require that department or 
agency support for any project be ter- 
minated or suspended in the manner 
prescribed in applicable program re- 
quirements, when the department or 
agency head finds an institution has 
materially failed to comply with the 
terms of this policy. 

(b) In making decisions about sup- 
porting or approving applications or 
proposals covered by this policy the 
department or agency head may take 
into account, in addition to all other 
eligibility requirements and program 
criteria, factors such as whether the 
applicant has been subject to a termi- 
nation or suspension under paragarph 
(a) of this section and whether the ap- 
plicant or the person or persons who 
would direct or has have directed the 
scientific and technical aspects of an 
activity has have, in the judgment of 
the department or agency head, mate- 
rially failed to discharge responsibility 
for the protection of the rights and 
welfare of human subjects (whether or 
not the research was subject to federal 
regulation). 

§ 219.124 Conditions. 

With respect to any research project 
or any class of research projects the 
department or agency head may 
impose additional conditions prior to 
or at the time of approval when in the 
judgment of the department or agency 
head additional conditions are neces- 
sary for the protection of human sub- 
jects. 



300 



68 

Mr. Bryant. Dr. Cox. 

STATEMENT OF JAMES D. COX, MJ)., PROFESSOR OF RADIO- 
THERAPY, M.D. ANDERSON CANCER CENTER, AND CHAIR- 
MAN, RADIOTHERAPY ONCOLOGY GROUP 

Dr. Cox. Mr. Chairman, I am James Cox, a physician involved 
in the treatment of patients with cancer and clinical research deal- 
ing with radiation oncology and other cancer treatments. 

My remarks will center on cancer treatments in the 1960s, the 
use of total body irradiation in cancer treatment, including the Cin- 
cinnati project, the status of clinical trials for the treatment of can- 
cer during the period in question, and the evolution of informed 
consent. 

The treatment of patients who were found to have cancer in the 
1960s was centered on the use of surgical removal or radiation 
therapy, which were the only known means to cure cancer. The 
drugs available to treat widespread cancer in patients at that time 
were minimally affected by current standards. Virtually all cancer 
treatments considered standard in the early 1960s had evolved 
without formal clinical trials. 

Patients whose spread of cancer was beyond local regional tu- 
mors were considered incurable. The aim of treatment of such pa- 
tients was to alleviate symptoms without any expectation of pro- 
longing the patient's life. 

Faced with the choices of doing nothing and administering local 
palliative treatments, or attempting experimental treatments, pa- 
tients frequently wished to do something unproven rather than 
doing nothing. 

Radiation therapy was known to produce predictable responses 
in most forms of cancer, and it was often curative — is often cura- 
tive for Hodgkin's disease, cervical cancer, advanced cancer of the 
mouth, throat, et cetera. Its limitation was that it could be applied 
only to local or regionally advanced tumors. Total body irradiation 
had been used with some success in the treatment of patients with 
chronic leukemias and lymphomas. 

It was reasonable to hypothesize that total body irradiation 
might have some benefit in widely disseminated cancer of other 
types. Enthusiasm for total body irradiation increased as the tech- 
nology evolved to reinfuse bone marrow to overcome potentially le- 
thal bone marrow depletion. 

Published data from the University of Cincinnati indicate that 
the total body irradiation trials were undertaken to determine the 
tolerance and effectiveness of this treatment in several types of 
cancer. The total body irradiation doses differed range from 100 to 
200 rads and were not considered in the range that would cause 
death. All but three patients had advanced cancer not considered 
curable by local regional treatments. 

Total body irradiation was given as an adjunct to three children 
considered at extremely high risk to the threat of metastasis. 

The study at the University of Cincinnati went under several lev- 
els of review by the National Institutes of Health, the editors of sci- 
entific journals. In addition, a special review, already alluded to, by 
Dr. Henry Kaplan of Stanford University, Frank Hendrickson in 



69 

Chicago, was requested by the American College of Radiology in re- 
sponse to an inquiry by Senator Mike Gravel in 1972. 

Clinical trials which compared experimental treatments to stand- 
ard treatments for patients with cancer were begun in the United 
States only in the mid-to-late 1950s. As these studies evolved, the 
concept of informed consent evolved. Formalization of informed con- 
sent by the National Institutes of Health was begun in the 1960s, 
and has continued to evolve to this day. 

In a 1973 publication of the Cincinnati studies by Dr. Saenger 
and colleagues, a statement is included which says. 

All patients gave informed consent in accordance with the directives of the Fac- 
ulty Research Committee of the University of Cincinnati College of Medicine and 
those of the National Institutes of Health. The use of formal, informed consent 
forms in this study antedated the above requirements by two years. 

In conclusion, radiation therapy is an important part of the ar- 
mamentarium of physicians in the care of patients with cancer. Be- 
cause of its effectiveness in the treatment of local regional tumors, 
whole body irradiation has been the subject of research for decades. 
At present, total body irradiation followed by bone marrow trans- 
plantation is considered a standard part of the treatment of many 
patients with leukemia, lymphoma and Hodgkin's disease, and it is 
under investigation still for other diseases. 

In the era prior to the establishment of bone marrow transplan- 
tation to support such treatment, lower, sublethal doses of total 
body irradiation were explored for patients with advanced cancers 
as a possible alternative to no treatment or to treatment with 
cytotoxic chemicals or hormones. 

The University of Cincinnati's studies of total body irradiation 
conducted between 1960 and 1971 were based on a reasonable hy- 
pothesis were conducted and reported in the scientific literature in 
a manner consistent with other clinical investigations, and seem to 
have used the accepted standards of informed consent for that pe- 
riod. 

One might judge them harshly from a perspective 20 years later, 
but they were reviewed and repeatedly approved by peers of the in- 
vestigators at the time the studies were conducted. 

Thank you. 

Mr. Bryant. Thank you. 

[The prepared statement of Dr. Cox follows:] 



70 



SUBCOMMITTEE ON ADMINISTRATIVE LAW AND GOVERNMENTAL RELATIONS 

COMMITTEE ON THE JUDICIARY 
HOUSE OF REPRESENTATIVES 

SUMMARY STATEMENT OF JAMES D. COX, M.D. 



Radiation therapy is an important part of the armamentarium of physicians in the care of 
patients with cancer. Because of its effectiveness in the treatment of local-regional tumors, whole 
body irradiation has been a subject of .research for decades. At present, total body irradiation 
followed by bone marrow transplantation is considered a standard part of treatment of many 
patients with leukemia, lymphoma, and Hodgkin's disease, and is under investigation for 
myeloma and cancer of the breast. In the era prior to the establishment of bone marrow 
transplantation to support such treatment, lower (sublethal) doses of total body irradiation were 
explored for patients with advanced cancer as a possible alternative to no treatment or treatment 
with cytotoxic chemicals or hormones. The University of Cincinnati studies of total body 
irradiation, conducted between 1960 and 1971 were based on a reasonable hypothesis, were 
conducted and reported in the scientific literature in keeping with clinical investigations of that 
period, and seem to have used the accepted standards of informed consent for that period. One 
might judge them harshly from a perspective 20 years later, but they were reviewed and 
repeatedly approved by peers of the investigators at the time the studies were conducted. 



71 



SUBCOMMITTEE ON ADMINISTRATIVE LAW AND GOVERNMENTAL RELATIONS 

COMMITTEE ON THE JUDICIARY 
HOUSE OF REPRESENTATIVES 

BIOGRAPHY OF JAMES D. COX, M.D. 



PRESENT TITLE & 
AFFILL\TION: 



Professor of Radiotherapy 

Hubert L. and Olive Stringer Chair in Oncology in Honor 

of Sue Gribble Stringer 

Coordinator, Interdisciplinary Program Development 

The University of Texas M.D. Anderson 

Cancer Center 
Houston, Texas 77030 



BIRTH DATE & PLACE: 
OFFICE ADDRESS: 



July 16, 1938; Steubenville, OH 

The University of Texas M.D. Anderson 

Cancer Center 
Interdisciplinary Program Development (Box 312) 
1515 Holcombe Boulevard 
Houston, Texas 77030 
(713) 792-2260 



EDUCATION: 

Undergraduate: 

Graduate: 

POSTGRADUATE 
TRAINING; 

1963 - 1964: 



1965 - 1966: 



1960, Kenyon College, Gambler, OH 

1965, University of Rochester School of 
Medicine and Dentistry, Rochester, NY 



Fellow: Clinical Oncology and 
Therapeutic Radiology, Penrose Cancer 
Hospital, Colorado Springs, CO 

Intern: (mixed with major in Medicine), 
University of Chicago, Chicago, IL 



1966 - 1969: Resident: Therapeutic Radiology, 

Penrose Cancer Hospital, Colorado 
Springs, CO 

1969 - 1970: Fellow: Therapeutic Radiology, 

Institute Gustave-Roussy, Villejuif, 
France 



Biographical Sketch of James D Cox, M U 



Page 1. 



72 



SPECIALTY BOARDS; 

1966: 

1971: 

MILITARY SERVICE: 

1970 - 1972: 



ACADEMIC & 
PROFESSIONAL 
APPOINTMENTS: 



Diplomate, National Board of Medical 

Examiners 
American Board of Radiology (Therapeutic 

Radiology) 

Major, US Army, Walter Reed General 
Hospital, Washington, DC 
Honorable Discharge 



FACULTY: 

1972 - 1974: 



1974 - 1977: 
1977 - 1982: 
1982 - 1985: 

1985 - 1988: 

1988 - 1992: 

1992 - : 

LOCAL: 



1992 -Present: 
NATIONAL: 

1972 - 1974: 
1983 - 1987: 



Assistant Professor of Radiology 

Georgetown University Hospital 

Washington, DC 
Associate Professor of Radiology 

Medical College of Wisconsin 
Professor of Radiology 

Medical College of Wisconsin 
Professor and Chairman 

Department of Radiation Oncology 

Medical College of Wisconsin 
Professor and Chairman 

Department of Radiation Oncology 

Columbia University College of 

Physicians and Surgeons 
Professor of Radiotherapy; Vice President for Patient 

Care and Physician-in-Chief, The University of Texas 

M.D. Anderson Cancer Center 
Professor of Radiotherapy; Coordinator, Interdisciplinary 

Program Development, The University of Texas 

M.D. Anderson Cancer Center 

Texas Radiation Advisory Board 

Member 

National Cancer Institute (NCI) 
Visiting Physician, Medicine Branch 
Cancer Research Manpower Review 
Committee, Division of Extramural Activities 



Biographical Sketch of James D Cox. M D 



Page 2 



73 



1987 - 1991: Board of Scientific Counselors 

Division of Cancer Treatment 
1987 - Present: Committee of Clinical Trials 

Cooperative Group Chairs 
1990 - 1993: Chairman, Committee of Clinical Trials Cooperative 

Group Chairs 



1985 - 1986: 

1986 - 1987: 



American Society for Therapeutic 
Radiology and Oncology (ASTRO) 

President 

Chairman, Board of Directors 



1981 - 1987: 

1981 - 1987 
1987 - 1993 
1987 - 1993 



1981 - 1987: 
1987 -Present: 



American College of Radiology (ACR) 

Chairman, Committee of Radiotherapeutic 

Research and Development 
Steering Committee of the Council 
Chancellor 
Chairman, Commission on Radiation 

Oncology 

Radiation Therapy Oncology Group (RTOG) 

Vice Chairman for Research Strategies 
Chairman, RTOG 



American Board of Radiology (ABR) 

1979 - 1989: Subcommittee for Written Examination 

in Radiation Oncology 
1981 -Present: Examiner, Oral Examination in Radiation Oncology 



1974 - 1979: 



Veterans Administration Lung Group (VALG) 

Chairman, Radiotherapy Committee Executive Committee 



1978 - 1980: 



Council of Radiation Oncology Committee 
Chairpersons (CROCC) 

Member 



EDITORIAL BOARDS: 

1981 -Present: 



Editorial Consultant: 
AMERICAN JOURNAL OF CLINICAL ONCOLOGY 
CANCER 
CHEST 
INTERNATIONAL JOURNAL OF RADIATION 

ONCOLOGY, BIOLOGY, PHYSICS 
JOURNAL OF CLINICAL ONCOLOGY 
NEW ENGLAND JOURNAL OF MEDICINE 



Page 3 



Biographical Sketch of James D Cox. M.D. 



74 



1985 -Present: 
1990 -Present: 

1990 - Present: 
HONORS i& AWARDS: 



Editor, INTERNATIONAL JOURNAL OF 
RADIATION ONCOLOGY, BIOLOGY, PHYSICS 

Site Editor for Rapid Communica- 
tions Section, INTERNATIONAL JOURNAL 
OF RADIATION ONCOLOGY, BIOLOGY, 
PHYSICS 

Editorial Board, LUNG CANCER 



1960: AB: Magna Cum Laude, Phi Beta Kappa 

1965: MD: With Honor 

1983: Fellow of the American College of 

Radiology (FACR) 
1984: Robert Fowler Fellow of the Anti-Cancer 

Council of Victoria, Australia 
1985: President: American Society for 

Therapeutic Radiology and Oncology 

(ASTRO) 
1986: Sixth Isadore Lampe Lecture 

University of Michigan 
1987: International Guest Lecturer, 

30th Armiversary, Department of 

Radiology, Hiroshima University 

Medical School 
1988: Honorary Member, Belgian Association for 

Radiation-Oncology 
1989: W. G. Cosbie Lecture, Royal College of 

Physicians and Surgeons of Canada 
1992: Gillies Memorial Lecture, The University of Iowa 

1992: William Caldwell Memorial Lecture, The University of 

Wisconsin 
1992: Hubert L. and Olive Stringer Chair in Oncology in Honor 

of Sue Gribble Stringer 
1993: Annual Oration in Radiation Oncology, Radiological 

Society of North America 
1994: Invited Lecturer, 7th International Symposium of the 

Foundation for Cancer Research. 

In addition. Dr. Cox is the author of 212 peer-reviewed journal articles, book chapters, and 
books. Copies of the bibliography are available upon request. 



Biographical Sketch ot James L) Cox, ML) 



Page 4. 



75 



SUBCOMMITTEE ON ADMINISTRATIVE LAW AND GOVERNMENTAL RELATIONS 

COMMITTEE ON THE JUDICIARY 
HOUSE OF REPRESENTATIVES 

PREPARED STATEMENT OF JAMES D. COX, M.D. 

The following comments are submitted at the request of Congressman Jack Brooks, Chair, 
House of Representatives Committee on the Judiciary. They pertain to hearings on radiation 
experiments performed by the University of Cincinnati Medical School. My formal remarks will 
center on: 

1) Cancer treatment in the 1960's; 

2) The use of total body irradiation in cancer treatment, including the Cinciimati 
project; 

3) The status of clinical trials for the treatment of cancer during the period in 
question and the evolution of informed consent. 

Status of Cancer Treatment During the 1960's 

The treatment of patients who were found to have cancer in the 1960's was largely 
centered on the use of surgical removal or radiation therapy. Such treatments were the only 
known means to cure cancer. Hormonal therapy and systemic cytotoxic chemotherapy were 
undergoing investigation: with rare exception, such systemic treatments were used with palliative 

Prepared Sutcmcm of Janies U Cox, M.U P»ge 1 



76 



intent or to retard progression of uniformly fatal diseases. The drugs available to treat 
widespread cancer in patients in the 1960's were minimally effective by current standards. 
Cancer of the bronchus or the colon infrequently responded to the available drugs, and breast 
cancer was only slightly more responsive. 

Virtually all standard cancer treatment in the 1960's evolved by clinical t^plications of 
best known therapies without formal clinical trials. Standard surgical procedures for cancer such 
as radical mastectomy, laryngectomy, resections of the large bowel, stomach and esophagus had 
not been tested in formal clinical trials. Similarly, radiation therapy considered standard, such 
as that for cervical cancer, had not been studied in clinical trials, but had proven to be curative 
over several decades. 

Patients whose tumors had spread beyond local-regional means of treatment (surgery and 
radiation therapy) were considered incurable. The aim of treatment of such patients was to 
alleviate symptoms such as pain, bleeding and obstruction of natural passages. Such palliative 
treatments were not undertaken with an expectation of prolonging the patient's life. Faced with 
the choices of doing nothing, administering local palliative treatment, or attempting highly 
experimental unproven treatments, the patient would frequently express a desire to do something 
unproven rather than doing nothing. 



Prepared Sutemenl ol James U. Cox. M.U. " Page 2 



77 



Total Body Irradiation in Cancer Treatment 

The responsiveness of tumors to ionizing radiations demonstrated soon after the discovery 
of x-rays by Roentgen ir 1 895 resulted in a steady increase in the use of such treatments. By 
the early 19S0's, high-energy photons became available for cancer treatment with Cobalt 60 
teletherapy units, betatrons, and linear accelerators, and the use of radiation therapy expanded 
rapidly. 

Radiation therapy was known to produce predictable responses in most forms of cancer 
and was often curative for Hodgkin's disease, cervical cancer, advanced cancer of the mouth, 
pharynx (throat) and larynx (voice box), etc. Its limitation was that it could be applied only to 
local or regionally advanced tumors. Total body irradiation had been used with some success in 
the treatment of patients with strikingly radioresponsive diseases such as chronic and acute 
leukemias and lymphomas. It was reasonable to hypothesize that total body irradiation might 
have some benefit in widely disseminated cancer. 

Even greater enthusiasm for total body irradiation as a component of cancer treatment 
developed as the technology to remove, store and reinfuse bone marrow to overcome the 
potentially lethal effects of high-dose systemic treatment was explored. E. Donnall Thomas, 
M.D., of the University of Washington, was awarded the Nobel Prize in Physiology and Medicine 
in 1990 for pioneering treatments which included total body irradiation with doses so high as to 

Prepared SUIcmcnt of James D Cox. MP Page 3. 



78 



be lethal were it not for bone marrow transplantation. 

Published data from the University of Cincinnati indicate that the total body irradiation 
trials were undertaken as phase I (to determine maximum tolerated dose) and phase II (to 
determine anti-tumor effect with specific diseases). The total body irradiation doses delivered 
ranged from 100 to 200 rads and were carefully calculated and measured. The trials involved 
three major forms of cancer—carcinoma of the colon, bronchus and breast. All but three patients 
had advanced cancer not curable by local-regional treatments. Total body irradiation was given 
as an adjuvant to local irradiation for three children with Ewing's sarcoma of the bone 
(considered at extremely high risk for the presence of distant metastasis). The treatment team 
consisted of radiation oncologists, two specialists in internal medicine and a medical physicist. 

The University of Cinciimati project underwent several levels of peer review. In addition 
to concurrence with the protocol by the participating members of the team, the studies were 
reviewed by the Faculty Research Committee of the University of Cincinnati College of 
Medicine. They also underwent review by the National Institutes of Health, editors of scientific 
journals, and a special review by Drs. Henry Kaplan of Stanford University, Frank Hendrickson 
of Chicago's Presbyterian St. Luke's Hospital, and Samuel Taylor, III, of the Presbyterian St. 
Luke's Hospital at the request of Robert W. McConnell, President, American College of 
Radiology, in response to a request by Senator Mike Gravel in 1972. 



Prepared Sutement ol James U. Cox, ML). " PigeX 



79 



Cancer Clinical Trials and Informed Consent 

The history of medicine is filled with clinical experiments undertaken with the intent to 
benefit individual patients or all mankind. Clinical trials which compared experimental treatments 
to standard treatments for patients with cancer were begun in England in the 1940's and in the 
mid to late 1950's in the United States. Seventeen clinical cooperative groups were established 
in 1956 with fimding from the National Cancer Institute. The conceptual framework leading 
from phase I (toxicity) to phase II (efficacy) to phase III (comparisons with standard treatment) 
was first formalized in the early 1960's at the National Cancer Institute. 

As studies in these cancer clinical cooperative groups evolved, the concept of informed consent 
evolved. Prior to 1965, patients enrolled in clinical trials were obviously asked to consent and 
such consent was usually documented in the medical record; formalization of this process began 
in the 1960's and has continued to evolve to the present time. Current standards include a 
description to the patient of the experimental treatment offered, specifics risks that such treatment 
might entail, statements to the effect that all risks are not fully understood and unexpected effects 
might occur, the possible benefits to the patients and society as a whole, and the express 
willingness of the physicians to treat the patient outside the protocol with the best standard 
treatments if the patient declines participation. It is now customary to provide the patient written 
information (usually two or three pages long); to let the patient keep a copy of this information 

Prepared Slaument of James D Cox, M.U. Page i. 



80 



so he or she may discuss it with family or friends; and, after opportunities for questions, to ask 
the patient to sign a consent form. The patient always has the right to withdraw from 
investigational treatment at any time, and to receive the best standard care. 

In a 1973 publication of the Cincinnati studies by Eugene L. Sanger, et al ("Whole Body 
and Partial Body Radiotherapy of Advanced Cancer", American Journal of Roentgenology. 
Radium Therapy, and Nuclear Medicine . Vol 1 1 7; 670-685), the following statement is included: 
All patients gave informed consent in accordance with the directives of the Faculty Research 
Committee of the University of Cincinnati College of Medicine and those of the National 
Institutes of Health. The use of formal, informed consent forms in this study antedated the 
above requirements by two years. 

Summary 

Radiation therapy is an important part of the annamentarium of physicians in the care of 
patients with cancer. Because of its effectiveness in the treatment of local-regional tumors, whole 
body irradiation has been a subject of research for decades. At present, total body irradiation 
followed by bone marrow transplantation is considered a standard part of treatment of many 
patients with leukemia, lymphoma, and Hodgkin's disease, and is under investigation for 
myeloma and cancer of the breast. In the era prior to the establishment of bone marrow 
transplantation to support such treatment, lower (sublethal) doses of total body irradiation were 

Prepared Staltmcnt ot James D Cox, M D. Page 6. 



81 

Mr. Bryant. Mr. Steger. 

STATEMENT OF JOSEPH STEGER, PRESIDENT, UNIVERSITY OF 
CINCINNATI, ACCOMPANIED BY STANLEY M. CHESLEY 

Mr. Steger. Thank you, Mr. Chairman and members of the com- 
mittee. I am Joseph A. Steger, president, University of Cincinnati. 
Stan Chesley has joined the University as an adviser, not really as- 
sistant, and he is former chairman of our board, and more than 
willing to help in this instance. 

I appreciate the opportunity to have a chance to present the ac- 
tions taken by the University of Cincinnati relative to the whole 
body radiation studies conducted at the then General Hospital 
some 20 to 30 years ago. 

lliere have been some seven independent investigations of these 
studies mostly 20 to 30 years ago, when the current University was 
asked by the press and the families to supply documents or 
records, we began voluntarily to compile immediately all of the 
records we had relative to the study. It was a very complicated 
task. The records were not in one place. The records were in writ- 
ten forms, some were written, some were microfiche. And much of 
it, m order to copy it, we had to send to the State of Washington 
to a special company that then took the microfiche and turned it 
into printed documents. 

Although we did this, we still had in our archives or we found 
some 11,233 pages of documents— all of which we have made pub- 
lic. We have made them public in terms of the press, in terms of 
inquiries, in terms of Government officials; and we will continue to 
make anything we find public. 

The patient records, however, we have not made public. They are 
being, however, given to the families. I apologize if it has taken a 
long time. Most of them are on microfiche, and it took us several 
months to get the microfiche into print. 

With the help of Senator Glenn and Congressman Mann we se- 
cured the original DOD contract, which we did not have. 

At the same time that we were undertaking to locate and repro- 
duce documents, we began— again, voluntarily— to search for the 
patients' families, some 88 families. As of this date, we have lo- 
cated 38 surviving relatives, and we are still trying to locate 50 
other patients' close relatives. We will continue to do so until we 
have exhausted different search techniques to find these families. 
We have also established a hot line so that people could check 
to see if they or a relative had participated in the studies. We have 
handled over 2,857 calls and cross-checks with the records to ascer- 
tain if any of the inquirers or their relatives had been in the study. 
Obviously, few had. 

We also feel a societal obligation to the surviving relatives Al- 
though we are no longer the same entity under which the studies 
were conducted, we have offered social work support and/or pas- 
toral counseling, should the families wish. 

As a public entity, we shall continue to cooperate in any way we 
can to provide information, should we uncover any additional docu- 
ments. At this time, we are fairly certain, in the sense of 90 to 100 
percent, that we do not have any other documents that have not 
been reported, because we have contacted the departments in the 



82 

studies, we have gone through all our archives, we have contacted 
every individual associated with the studies, and as far as we are 
concerned, we cannot find any other documents. 

Thank you for allowing my testimony. I shall be glad to answer 
any of your questions. We will continue to cooperate in any way we 
can. 

Mr. Bryant. Thank you. 

[The prepared statement of Mr. Steger follows:] 



83 



TESTIMONY 

COMMITTEE ON JUDICIARY 

SUBCOMMITTEE ON ADMINISTRATIVE 

LAW AND GOVERNMENTAL RELATIONS 

APRIL 11, 1994 

MR. CHAIR, MEMBERS OF THE COMMITTEE, I AM JOSEPH 
A. STEGER, PRESIDENT, UNIVERSITY OF CINCINNATI. 

I APPRECIATE THE OPPORTUNITY TO HAVE A CHANCE TO 
PRESENT THE ACTIONS TAKEN BY THE UNIVERSITY OF 
CINCINNATI RELATIVE TO THE WHOLE BODY RADIOTHERAPY 
STUDIES CONDUCTED, AT THE THEN GENERAL HOSPITAL, 
SOME TWENTY TO THIRTY YEARS AGO. 

THERE HAVING BEEN SOME SEVEN INDEPENDENT 
INVESTIGATIONS OF THESE STUDIES MOSTLY 20 TO 30 



84 

YEARS AGO, WHEN THE CURRENT UNIVERSITY WAS ASKED BY 
THE PRESS AND THE FAMILIES TO SUPPLY DOCUMENTS OR 
RECORDS, WE BEGAN TO COMPILE IMMEDIATELY ALL THE 
RECORDS WE HAD RELATIVE TO THE STUDY. MUCH TO OUR 
SURPRISE, ALTHOUGH IT WAS A COMPLICATED TASK, WE 
STILL HAD IN OUR ARCHIVES OR WE FOUND SOME 8,200 
PAGE OF DOCUMENTS-ALL OF WHICH WE HAVE MADE PUBLIC. 
AND WITH THE HELP OF SENATOR GLENN AND CONGRESSMAN 
MANN, WE SECURED THE ORIGINAL D.O.D. CONTRACT. 

AT THE SAME TIME THAT WE WERE UNDERTAKING TO 
LOCATE AND REPRODUCE DOCUMENTS, WE BEGAN A SEARCH 
FOR THE PATIENTS' FAMILIES (SOME 88 FAMILIES). AS 
OF THIS DATE, WE HAVE LOCATED 38 SURVIVING RELATIVES 
AND WE ARE STILL TRYING TO LOCATE 50 OTHER PATIENTS' 
CLOSE RELATIVES. 

WE ALSO ESTABLISHED A HOT LINE SO THAT PEOPLE 
COULD CHECK TO SEE IF THEY OR A RELATIVE HAD 
PARTICIPATED IN THE STUDIES. WE HAVE HANDLED OVER 



85 

1.000 CALLS AND CROSS CHECKS TO ASCERTAIN BY PATIENT 
RECORDS (OF THESE 1.000 SOME CALLS) IF ANY OF THE 
INQUIRERS OR THEIR RELATIVES HAD BEEN IN THE STUDY- 
OBVIOUSLY FEW HAD. 

WE ALSO FEEL A SOCIETAL OBLIGATION TO THE 
SURVIVING RELATIVES. ALTHOUGH WE ARE NO LONGER THE 
SAME ENTITY UNDER WHICH THE STUDIES WERE CONDUCTED. 
WE HAVE OFFERED SOCIAL WORK SUPPORT AND/OR PASTORAL 
COUNSELING SHOULD THEY WISH. 

WE AS A PUBLIC ENTITY SHALL CONTINUE TO COOPERATE 
IN ANY WAY WE CAN TO PROVIDE INFORMATION SHOULD WE 
UNCOVER ANY ADDITIONAL DOCUMENTS. AT THIS TIME, WE 
ARE 90% CERTAIN THAT WE DO NOT HAVE ANY OTHER 
DOCUMENTS THAT HAVE NOT BEEN REPORTED. 

THANK YOU FOR ALLOWING MY TESTIMONY. I SHALL BE 
GLAD TO ANSWER ANY OF YOUR QUESTIONS. 



86 

Mr. Bryant. Dr. Soper, in your written statement, you said one 
of the reasons the Department was interested in the experiments 
was to understand the influence of radiation on combat effective- 
ness. Why couldn't the Department fund an experiment using its 
own healthy servicemen as opposed to innocent civilian cancer pa- 
tients that were used in these studies? 

Dr. Soper. I can't, Mr. Bryant, give you a direct answer to that. 
I know that in developing the types of criteria for battle, whether 
it is on a conventional, a chemical, or a nuclear battlefield, infor- 
mation is gathered from many sources — ^from animal studies, for 
example, and I think, also from studies with people in uniform and 
civilian members of the Department of Defense. 

This information that we obtained from the University of Cin- 
cinnati, sir, was one part from many different sources. We put to- 
gether those manuals that perhaps are offensive to some, but those 
manuals are required by the commander on a nuclear battlefield to 
fight in a hostile environment. Like it or not, that is the business 
I am in; and I am doing that the best that I can. All the members 
of the Department of Defense are. 

Mr. Bryant. Did the Department of Defense carry out any such 
experiment on healthy servicemen? 

Dr. Soper. I will have to answer that, for the record, I don't 
know of any. 

[The information follows:] 

Our record search is still ongoing, but to date we have not discovered any such 
experiments. 

Dr. Soper. Let me say, I do know of other experiments besides 
the Cincinnati experiments that were done, reported in the lit- 
erature, having to do with total body irradiation, as Dr. Cox point- 
ed out — ^that contributed to our overall data base. But, I do not 
know the answer to your specific question. 

Mr. Bryant. If the Department received a proposal for such an 
experiment on healthy servicemen, would it have been funded? 

Dr. Soper. There are a series of protocols through which funding 
for human-use experiments must pass. The rules for that in the 
Department of Defense started as early as 1953, with a then top 
secret memorandum from Secretary of Defense Charles Wilson to 
the Secretaries of the military services, which outlined in some spe- 
cific detail the rules for human-use experimentation of healthy sol- 
diers and civilian members. 

Mr. Bryant. The Department did not pay $651,000 up front for 
the experiments. Rather, it paid $25,000 for the initial contract, 
and then increased the amount for close to 10 years as the contract 
was renewed and modified? 

Dr. Soper. Yes, sir. 

Mr. Bryant. Before approving the contract or its modifications, 
did the Department of Defense officials inquire as to the potential 
harm being caused to patients being administered such high doses 
of radiation? 

Dr. Soper. I don't know the answer to that. The available surviv- 
ing records do not show any such inquiry. I have a few of the docu- 
ments, I think you have them as well, that have survived, these 
many years; and the approval process in the Department of De- 



87 

fense is, as far as that documentation is concerned, rather super- 
ficial. 

Let me be more specific. I have been able to find nothing in the 
records of specific questions sent back to the University of Cin- 
cinnati with regard to informed consent or patient selection cri- 
teria. It was our purpose to use the information from the psycho- 
logical and psychiatric tests and blood and urine tests. 

Mr. Bryant. Did the project officer monitor the effect on patients 
as part of his responsibilities? 

Dr. SOPER. There is no indication that the project officer, what 
we call the contracting officer's representative, (COR) did so. As a 
matter of fact, some of the records suggest that the University com- 
mented on the fact that they had total scientific freedom with re- 
spect to their work. 

Now, I was a contracting officer's representative at the Defense 
Nuclear Agency for much of my career, sir, and I was responsible 
for and expected to do exactly that, be a contracting officer's rep- 
resentative, ask the technical questions and ensure that the Amer- 
ican taxpayer was getting what he paid for. 

That is not to say that it wasn't done, there is just nothing in 
the record. If you are interested, we have made repeated attempts 
at locating a nondestroyed file. As I said, as part of the normal con- 
tract destruction process that occurs by law eVz years afl;er the con- 
tract is terminated, the file is destroyed. We have called people 
that we have known, we have tried to locate somewhere in some- 
one's desk drawer a contracting officer's representative (COR) file 
that would give us some indication of that. 

Now, there is no indication either that there was or there wasn't 
influence by the contracting officer's representative. 

Mr. Bryant. Are any of the project officers alive? Isn't anybody 
around that was involved? 

Dr. Soper. The gentleman at the Defense Nuclear Agency, the 
senior official, is dead. At least two of the people whose names ap- 
pear on the forms about which I just spoke have died. I spoke with 
another gentleman on the telephone the other day in preparation 
for this hearing, and his recollection of involvement was of no help. 
The contracting officer at the Defense Nuclear Agency, while still 
living, IS medically impaired and is not able to contribute. So we 
have tried. 

Mr. Bryant. My time has expired. 
Mr. Mann. 

Mr. Mann. Thank you, Mr. Chairman. I want to pursue first the 
hne that is similar to what Mr. Bryant has been pursuing. I read 
with some care the original proposal by Dr. Saenger, the original 
contract, the periodic reports that were sent to the Department of 
Defense; and nowhere can I find any evidence that anybody at the 
Pentagon or with the Government had the least bit of concern 
about where the patients were coming from, what the consequences 
to them niight be of the administration of whole body irradiation 
that was being reported from the Pentagon perspective at great 
length and great detail insofar as the various parameters that were 
being used in the study. 



88 

I mean, didn't somebody at some point ask at least in their own 
mind, I wonder who these people are and what else is happening 
to them? 

Dr. SoPER. Congressman Mann, I agree with what you are say- 
ing. There is nothing in the file that has remained that suggests 
that that was done. That is not to say it wasn't. But I can find 
nothing, either. 

Mr. Mann. You make the point in the attachment to your state- 
ment that the title of the report was changed in 1968, whereas pre- 
viously the report had talked totally about metabolic changes, now 
we are talking also about therapeutic efforts. 

Do you have any knowledge of the reason for that title change? 

Dr. SoPER. No, I do not. I do note it, however. 

Mr. Mann. To your knowledge, were whole body radiation experi- 
ments of the kind that the Pentagon paid for conducted at the Uni- 
versity of Cincinnati either before or after the period of the con- 
tract with the Pentagon? 

Dr. SoPER. There is reference in the file to experiments at the 
Sloan-Kettering Cancer Research Institute at the University of 
Baylor School of Medicine, and at the M.D. Anderson Clinic, I be- 
lieve. There are those references in the file of related whole body 
irradiation experiments as contributory to Department of Defense 
needs. 

And after that, I do not know of any. Perhaps we can call Cap- 
tain Bumgarner in a moment. 

Mr. Mann. Did any of that work involve Dr. Saenger or any of 
his personnel? 

Dr. SoPER. No, I don't think the work at Sloan-Kettering or at 
M.D. Anderson did. Dr. Saenger's work is referenced, along with 
others, in military documents that relate to military radiobiology. 

Mr. Mann. Can you tell us how often in the 1950s an unsolicited 
proposal such as Dr. Saenger's would have come to the Pentagon? 

Dr. SoPER. I don't know, but I will give you my experience begin- 
ning at the Defense Nuclear Agency in 1972, primarily a research 
and development organization funded by 6.2 money, if that mesms 
anything — it was primarily research and development funds. A sig- 
nificant portion — ^that is, better than 10 percent of the work that 
was done in the early 1970s when I was there — was done as a re- 
sult of unsolicited proposals. 

The Department came under criticism by Members of Congress 
and others that there was an indication that these weren't unsolic- 
ited, perhaps they were solicited unsolicited proposals. So it nor- 
mally happened that the contracting requirements were tightened 
up. 

There is no indication, sir, that this was a solicited unsolicited 
proposal. 

Mr. Mann. Are you aware of any other studies similar in the 
overall purpose or scope to the one that we are looking at today, 
that was funded by the Department of Defense at any time? 

Dr. SoPER. Yes, I believe mention is made of the work at Sloan- 
Kettering and M.D. Anderson. I have information on that. I will 
provide that for the record. 

[The information follows:] 



89 



We have identified several studies supported by the 
Department of Defense in which radiation effects on humans 
were studied. 

In our records there are three reports that cover 
research conducted at Sloan-Kettering Institute for Cancer 
Research in New York during the 1950 's and early 1960 's. 
The work at Sloan-Kettering exposed patients with widespread 
cancer to low-level doses of total body irradiation to study 
post-irradiation syndrome in humans and to evaluate the 
effects on the modification of tumor response. 

In the early to mid-1950 's research at M.D. Anderson 
Hospital in Houston, Texas evaluated the systemic and 
clinical effects induced in 263 cancer patients by whole 
body x-irradiation with nominal air doses of 15r to 200r. 
Another study was conducted at the Baylor University College 
of Medicine, also in Houston, from 1954 to 1964. This 
research studied the effect of total body irradiation on the 
immunologic tolerance of bone marrow and homografts of other 
living tissue. A third study in Texas during the same 
general time period (1956 to 1962) was conducted by the 
University of Texas to study the effects of total body 
irradiation and local irradiation on the metabolism of the 
hematopoietic system in humans. 

Another study we have identified was conducted from 
1960 until 1963 at the University of Southern California. 
The research was conducted to observe the effect in humans 
of 250-300r of total body irradiation. Also, from 1972 to 
1976 at the Armed Forces Radiobiology Research Institute, 
leukemia patients were treated with total-body irradiation 
to ablate their bone marrow so that a bone marrow transplant 
could be done to cure their leukemia. 

I want to reiterate that this is current information 
and that our record search continues. 



90 

Mr. Mann. Those were DOD-funded? 

Dr. SOPER. Yes, they were. In fact, supported by the Defense 

Atomic Support Agency. i.. i • , • j. 

Mr. Mann. For the same question, developmg a biological indica- 
tor to indicate 

Dr. SoPER. Yes. 

Mr Mann. Let me get the timing. That was before or after or 
during the UC— 1960 to 1971? 

Dr. SoPER. I have a report here on the work at Baylor University 
College of Medicine. It is the final report for February 1, 1963, to 
January 31, 1964, entitled "The Effect of Total Body Irradiation on 
Immunologic Tolerance of Bone Marrow and Homographs of Other 
Living Tissue, Tables and Charts Therein." 

I also have a paper by M.D. Anderson Hospital Tumor Institute, 
entitled "Systemic and Clinical Effects Induced in 263 Cancer Pa- 
tients by Whole Body Irradiation with Nominal Air Doses of 15 to 
200 Rads." 

Mr. Mann. What hospital did you say it was? What institution 

did you say it was? t., t-. a 

Dr. SOPER. Radiology Department, University of Texas, M.D. An- 
derson Hospital Tumor Institute, TX. This was done for the De- 
partment of Radiology, School of Aviation Medicine, U.S. Air Force. 

As part of the record, I have, and I think I gave it to you or at 
least I hope I did, a memorandum of November 12, 1958, from Lt. 
Col. Arthur Sullivan, Assistant Chief of Biophysics and Astronau- 
tics. The Saenger proposal has received favorable comment from 
Colonel Maupin, Colonel Isherwood, Colonel Hutgerhang, I think 
he died, and Colonel Cox. In the opinion of the undersigned, the 
work being done by Dr. Collins at Baylor and the Sloan-Kettering 
Institute, who are working with humans 

Mr. Mann. I know Sullivan's name. I don't think I have that par- 
ticular document. I would like to have it. I guess, expanding on Mr. 
Bryant's question, would any of those five people be alive and be 
able to offer information to us? 

Dr. SoPER. We are trying to track those people down. I think Dr. 
Sullivan, we found, died a month or so ago. But we are still trying 
to track those people down, sir. 

Mr. Mann. Finally, Dr. Soper, you mentioned there was a 1953 
top secret document that set forth specific standards for informed 
consent. Is that something you can now — I assume that is not still 
classified. 

Dr. SoPER. It is not. It was unclassified in 1975 or 1979. 

Mr. Mann. Have you had the occasion to ponder whether the in- 
formed consent procedures that were used in this particular project 
meet the standards in that memorandum? 

Dr. SoPER. Good question. I have it here, and I will search for 
it if you don't have it, the memorandum from the Secretary of De- 
fense, Mr. Charles Wilson, in 1953, was specifically for human use 
of military people, in uniform, and Department of Defense civilian 
workers, and it did not speak to the issue of contracted studies like 
the work here at the University of Cincinnati. 

Mr. Mann. Could you give us a flavor of what information would 
be given to a member in uniform, the serviceman, before an experi- 
ment? 



91 

Dr. SOPER. Yes, if I can find it. 

Mr. Mann. OK. 

Dr SoPER The copy I have here is dated February 26, 1953: it 
was declassified, I can't read when it was, 1975; and it speaks to 
a number of criteria. The voluntary consent of the human subject 
is absolutely essential, and it gives three very specific subpara- 
graphs with respect to the criteria for voluntary consent. 

The experiment, that was number A, B, the experiment should 
be such as to yield fruitful results for the good of society 
unprocurable by other methods or means of study, and not random 
and unnecessary in nature. C, the number of volunteers used shall 
be kept to a minimum. 

I will go through the others if you wish. 

Mr. Mann. If you could, give us a copy of that for the record 

Dr. SoPER. Of course. 

[The information follows:] 



92 



C O 1' Y 



SECRETARY 0\ DlTrNSC 
Woshi ngl on 



26 Feb 1953 



HLMOR(VMDUH FOR TilE SliCRETAKY OF THK ARIIY 

SECRETARY 01' TUn MAVY 
SECRETARY OF THE AIR FORCE 

SUBJECT: Use of Human Vo.lunto«!rs in Experimental RcsRarch 

1. Based upon a rocommGrdntion oil the Armed Forces Medical 

^ Policy Council, that human subjcctr, be employed,- under re''ogni::!nd 
safcguarJr. , as the only Cea.siblo me.ins for realistic evali'.Cfi-.ion 
and/or devcjlopment of effective pi.e\;entive measures of defence 
atjainsi: atomic, biological or chemical ayents, the policy sat 
fortli be.Tov; v/ill- govern tlio uce of human volunteers by the 
Department of Defense in e::pe)-imental research in the fielur. 
of atomic, biological and/or chemical warfare. 

2. By reason of the basic medical responsibility in connection 
v;ith the development of deftmse of all types against atomic, 
biological and/or chemical warfare agents, Amec' Services perso.Tuel 
and/or civilians on duty at installations engaged in such rcsr-arch 
slii'.ll be permitted to actively participate in a] 1 phases of the 
program, sucli participation sha] 1 be subject to the ioI]o;;ing 
conditions : 

a. The voluntary consent of the human ubject is 
absolutely essential. 

(1) This means that the person invol cd shouli^ 
liave legal capacity to give consent; shoul'". be so 
^ situated as to be able to exercise f ee pove..; of 

clioice, without thp intervention of ny element of 
force, fraud, deceit, duress, over-r aching, or otlier 
ulterior form of constraint or coercion; and should 
have sufficient i^iio's'ledqo and compre^icnsicr oj; t'.ic 
elements of the subject matter involved ov to 
enable him to i.ialcc an understanding and enlightened 
decision. This lal-.cci: cli%mcnt requires that bo.^ore 
the acceptance of an affirmative decision by the 
experimental subject there should bo made knov/n 
to him the nature, duration, and purpose of 
the experiment; tlie method and' means by 




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UHCLASSiriED 21: Aug 
per S. Clements 
DDRfiE USD (Pa). 



75 



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^5 which it is to bf coiulucM-.i^d; nil iiiconvc)ii(.'nci;.o 
and liozards rcaf^onnbly Lo be cxpr:ctcd; and tlie 
effects; upon hir; health or pcvsoii v;hicli may )50Gsibly 
come from his participation in tlie experiment. 

(2) The concept of tlie human subject shall be in 
writing, his sirjnature shall be affixed to a written 
instument setting forth substantially the afore- 
mentioned requiromont.s and shall be signed in the 
presence of at least one witness who shall attest to 
such signature in v;ritinq. 

(a) In experiments where personnel from more 
than one Service are involved the Secretary of the 
Service which is exercising primary responsibility 
for conducting the experiment is desi.gnated to pre- 
pare such an instrimeiit and coordinate it for use 
by all the Services having human volunteers involved 
in the experiment. 

(3) The duty and responsibility for ascertaining 

the quality of the consent rests upon eacli individual 
who initiates, directs or engages in the experiment. 
It is a personal duty and responsibility which may 
not be delegated to another with impunity. 

b. The experiment should be sucli as to yield fruitful 
results for the good of society, unprocurable by other methods 
or means of study, and not random and unnecessary in nature. 

c. The number of volunteers used shfll be kept at a 
minimum consistent with item b. , above. ;' 

d. The experiment should be so desit ned and based on the 
results of animal experimentation and a knov;ledge of the natural 
history of the disease or other problem under study that the 
anticipated results will justify the performance of the experiment. 

c. The experiment should be so conducted as to avoid all 
unnecessary physical and mental suffering a;id injury. 

f. No experiment sliould be conducted where there is an 
a priori reason to believe that deatli or disabling injury will 
occur. 

g. The degree of risk to be taken should never exceed 
that determined by the humanitarian. importance of the problem 
to bo solved by tho experiment. 



Dov/ngradcd to 
UNCLASSIFIiCO 22 7\\i(j 7 5 



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; h. Proper proparcition cliovi.ld be ninclo and adcquito 
facilities provided to protect the experimental subject against 
even remote possibilities of injury, disability, or death. 

i. The experiment should be conducted only by scientifi- 
cally qualified persons. The highest degree of skill and care 
should be required through all stages of the experiment of those 
who conduct or engage in tlio experiment. 

j. During the course of the experiment the human subject 
should be at liberty to bring the experiment to an end if he has 
reached the physical or mental state where continuation of the 
experiment seems to him to be impossible. # 

k. During the course of the experiment the scientist in 
charge must be prepared to terminate the experiment at any stage, 
if he has probable cause to believe, in the exercise of the good 
faith, superior skill and careful judgment required of him that a 
con-tinuation of the experiment is likely to result in injury, dis- 
ability, or death to the experimental subject. 

1. The established policy, which prohibits the use of 
prisoners of war in human experimentation, is continued and they 
will not be used under any circumstances. h 

3. The Secretaries of the Army, Navy and Air Force are 
authorized to conduct experiments in connection v/ith tlie develonmsr.t 
of defences of all types against atomic, biological and/or chcmic.Tl 
warfare agents involving the use of human subjects within the 
limits prescribed above. 

4. In each instance in v/hich an experiment is proposed pur- 
suant to this memorandum, the nature and purpose of the propos;cd 

vexperiment and the name of the perc;on v/ho •.nil be in charge of 
such experiment shall be submitted for approval to the Secretary 
of the military department in v;hich the proposed experiment is to 
be conducted. No such experiment sliall be undertaken until such 
Secretary has approved in writing the experiment proposed, the 
person who will be in charge of conducting it-, as well as informing 
the Secretary of Defense. 

5. The addresses will be responsible for insuring compliance 
with the provisions of this memorandum within their respective 
Services. 



/signed/ 
C.E. WILSON 



Copies furnished: 
Joint Chiefs of Staff 
Research and Development Board 



TOP- SECRET 



Downgraded to UNCLASSIfJiJD 
22 Aug 75 



95 

Mr. Mann. Finally, in this round, Dr. Soper, there came a point 
in time when, as I understand it — maybe we will have more detail 
later — the project at UC had multiple funding sources in terms of 
the dollars that were necessary to treat the patients. At some point 
in the 1960s, before the project ended, NIH, at least for a period, 
declined to offer funding based on some moral issues, that is some- 
body else's characterization. 

Was the Pentagon aware of that refusal by NIH at the time? 

Dr. Soper. At the time, the records don't show that they were 
or they weren't. I am in contact with HHS. Part of the interagency 
working group has allowed senior members of each one of the De- 
partments to meet together on a very regular basis and talk seri- 
ously about these issues, and the senior official at HHS is research- 
ing that for us. I hope to have an answer to that question. 

Mr. Mann. Mr. Chairman, I have other questions, but I will wait 
to the second round. 

Mr. Bryant. Mr. Portman. 

Mr. Portman. Thanks, Mr. Chairman. 

Dr. Soper, thank you for the help you have provided me and my 
staff over the last couple of months. I know our dialogue will con- 
tinue. 

Dr. SoPER. I hope so. 

Mr. Portman. I really want to echo some of the concerns the 
chairman raised in terms of the efforts you are making to contact 
people who were directly involved at the time. It sounds as though 
you have made some efforts, and we have talked about that. I 
would just hope that we would redouble those efforts now, to try 
to find out as much as we can about what the DOD role was, how 
much oversight there might have been or not have been. The 
records, as you indicate, are very sparse in that regard. 

That is an issue that I know this subcommittee, as well as the 
Congress as a whole, is intensely interested in. 

With regard to documentation between the Cincinnati General 
Hospital and DOD, let me ask you, was there any evidence, par- 
ticularly in the documents from the earlier years, that the radi- 
ation proposed to be administered to patients was expressly de- 
signed to treat cancer? 

Dr. SoPER. Quite to the contrary. I think the information that 
you see in the early documentation — the first reports, I have their 
numbers — clearly does not state treatment of cancer as a part of 
the reports. As I said early, those earlier reports, for those of us 
who are looking at them for the first time, are certainly troubling. 

And, as I have talked about this issue with medical ethicists in 
the Department of Defense and other places — my younger brother 
is a radiologist and I have talked with him about this — is open for 
interpretation. 

It is one element that I hope the advisory committee, that is 
made up of ethicists and radiologists like those that are here at the 
table today, will look at and come to a view on. Perhaps it was just 
a badly written report. I can't judge; I am not qualified to judge 
that. 

Mr. Portman. Getting back to the documents for a moment, how 
about the 1958 proposal from the University to the DOD with re- 
gard to this issue? 



96 

Dr. SOPER. There is certainly an early indication that we have 
an appraisal of human studies and the radiobiological aspects of 
weapon effects. The word weapon appears. The report was written 
by Dr. Saenger and Dr. Friedman. It was prepared for the Defense 
Atomic Support Agency. 

The date I have here is November 14, 1962, and this is an ap- 
praisal, I presume at that time, of the work that is being performed 
by the Department of Defense. They talk about the adequacy or the 
inadequacy of animal data. And it says. 

Nevertheless it is essential to consider further well-planned studies in patients as 
long as the following criteria are fulfilled: There is a reasonable chance of thera- 
peutic benefit to the patient; the likelihood of damage to the patient is no greater 
than that encountered from comparable therapy of another type; and the facilities 
for support of the patient and complications of treatment offer all possible medical 
services for successfiil maintenance of the patient's well-being. 

So this, Mr. Portman, is in 1962, written word from a Depart- 
ment of Defense-supported document written with Department of 
Defense funds, that speaks to the therapeutic issue associated with 
these experiments. It is the earliest one that I can find on the 
record. 

Mr. Portman. This is not directly related to the then Greneral 
Hospital situation? This was a general document with regard to 
DOD-funded projects? 

Dr. SoPER. Oh, no. This was supported by DOD. This was work, 
an appraisal of the work, that they were performing, prepared for 
the Defense Atomic Support Agency under contract; and the num- 
ber of the contract was one of the three contracts that the Depart- 
ment of Defense had with the University of Cincinnati. 

Mr. Portman. You mentioned earlier that you were a contracting 
officer's representative yourself in a previous life? 

Dr. SoPER. Yes, sir. I would like to go back. 

Mr. Portman. It is too late. 

Dr. SoPER. Yes, you are right. 

Mr. Portman. I would like to ask you a general question, and 
that is, should there have been more oversight, from what you have 
been led to believe, from the discussions with people and from the 
documents? 

Dr. SoPER. Absolutely. It is the responsibility of the contracting 
officer's representative. You don't raise your hand and swear to 
that, but one of the tenets of doing a good job at the Defense Nu- 
clear Agency, or the Defense Information Systems Agency, or the 
CIA, or any agency in representing taxpayers' money is to be an 
informed buyer. I took courses early on in my career that told me 
how to be a good COR, what to ask for, and what to expect in re- 
sponse. 

Mr. Portman. Let me ask you then a follow-up question. This is 
something that I found very unusual in looking through the docu- 
ments. 

Should there not have been a DOD report at the conclusion of 
this study? Should there not have been a DOD report at the conclu- 
sion of the study in 1971? 

Dr. SoPER. Let me ask for clarification. Do you mean when the 
contract was terminated, a report by the Department of Defense 



97 

saying, we, the Department of Defense, spent $650,000 of your 
money, this is what we got for it A, B, C? 

Mr. PORTMAN. Exactly. I am not aware of the existence of any 
such report. 

Dr. SOPER. I am not either. The information we paid for appears 
throughout radiobiology and miHtary medical radiobiology lit- 
erature. So it was used extensively in preparing documents like I 
have before me regarding military radiobiology, et cetera. 

Mr. PORTMAN. Do you find it unusual that there was not a report 
at the end of the study? 

Dr. SoPER. It is a good question. I am now trying to think in my 
career, whether or not each contract that ended, ended with a re- 
port, and the DOD provided a report on this as to what we got or 
didn't get. I am not sure that wouldn't have been the norm. I think 
that would not have been the norm. 

Mr. PoRTMAN. Not have been the norm? 

Dr. SoPER. No, sir. 

Mr. PORTMAN. One final question, Mr. Chairman, and that is 
simply, are there any documents out there of which you are aware, 
classified or unclassified, that DOD has not yet disclosed? 

Dr. SoPER. Oh, let 

Mr. PoRTMAN. Of which you are aware. 

Dr. SoPER. There are no documents of which I am aware, classi- 
fied or unclassified, that aren't going to be a part, that are not, or 
will be a part of the record retrieval process and the documents 
that we submit to the advisory committee for their review. The ad- 
visory committee, by the way, is meeting for the first time on April 
21 and 22. I am expected to brief them on the results of the DOD 
record retrieval process, I believe this will be a major element. 

Mr. PoRTMAN. One follow-up, then, to that. Are you saying then 
that the working group or the advisory committee to the working 
group may receive documents that this subcommittee does not re- 
ceive, or the public does not receive? 

Dr. SoPER. No. No. 

Mr. PORTMAN. When you say 

Dr. SoPER. What I am sa3dng is that the process through which 
we are going, this interagency working group, is open. It has been 
advertised as intensive and providing a view into the cold war ex- 
perimentation, good or bad, sir, we will provide to you, as well as 
to the advisory committee, the records that we find. 

Mr. PoRTMAN. Thank you. 

Mr. Bryant. Dr. Soper, I think it is important to pursue this 
question about the NIH. Apparently, the National Institutes of 
Health was asked to fund experiments, and they refused to do so 
because of the moral concerns; at least that is what the indications 
are. 

Was it your testimony that the Department of Defense did not 
know about that refusal? 

Dr. SOPER. I do not know the answer, specifically. I think we did 
not, but if I can leave it at that, I think we did not — and I am re- 
searching that — I will supply that answer for the record. 

[The information follows:] 

The University of Cincinnati Ad Hoc Committee Report of January 1972 noted 
that a proposal entitled Protection of Humans with Stored Autologous Marrow was 



98 

submitted to NIH in 1966 or 1967 by Dr. Ben Friedman, one of Dr. Saenger's re- 
search colleagues. The report further noted that the application was not approved 
and that reason for this decision was not disclosed. Our efforts, and consvdtations 
with HHS and NIH, have not revealed additional information on this matter. How- 
ever, docxmients provided by the University of Cincinnati do reveal that during this 
same time period Dr. Saenger had three research contracts with HEW (two) and 
NIH (one). 

Mr. Bryant. Dr. Cox, you talked about the peer reviews that 
took place regarding all this activity, including one sought by the 
American College of Radiology. Were they aware that the National 
Institutes of Health had refused to participate in experiments 
based upon moral concerns? 

Dr. Cox. Not to the best of my knowledge. 

Mr. Bryant. Were you aware of it before this morning? 

Dr. Cox. I was not. 

Dr. SOPER. May I ask a question? 

Mr. Bryant. Yes. 

Dr. SoPER. Is this NIH refusal, does that appear in the written 
record for the first time in the University of Cincinnati ad hoc com- 
mittee report? I mean, I have a copy of that. 

Mr. Bryant. Yes, that is correct. That is exactly where it ap- 
pears. 

Dr. SoPER. Thank you. 

Mr. Bryant. We are seeking more information from the National 
Institutes of Health about it. They have not yet constructed their 
response. 

Dr. Cox, your statement quotes a 1973 article by Dr. Saenger 
saying that all patients gave informed consent to the radiation ex- 
periments. Do you have any evidence as to whether the statement 
in the article is accurate? 

Dr. Cox. I have no corroborating evidence. 

Mr. Bryant. Did the individuals in these experiments have can- 
cers that would benefit from radiation treatment? 

Dr. Cox. Many of them, as expressed by one of the earlier family 
members, suggested that local irradiation was used for some of the 
patients, and even suggested from, I believe, maybe a 2-year pe- 
riod, 2-year interval to the time when the total body irradiation 
was given that it may have been of benefit. So the local radiation 
that was given to these patients would very likely have been of 
benefit. 

The total body irradiation was experimental, and was presum- 
ably undertaken on the hypothesis that it might have been a bene- 
fit to patients for whom no other systemic treatment was available. 

Mr, Bryant. We understood that portion of your testimony. Some 
of this was — as you testified, was experimental, and ill patients 
with very little hope of survival were willing to undergo the tests. 

Let me ask you, what types of cancer were radio sensitive or 
were known to be radio sensitive at the time? 

Dr. Cox. A wide variety. The exception were those that were not 
considered radio sensitive. However, they required high doses to 
produce control of the disease, and such high doses could only be 
given locally. They could not be given to the entire body. So the 
question was, could lower doses be of some benefit if given to the 
whole body, and that was the h3rpothesis. 

Mr. Bryant. What tjrpes of cancers are radio resistant? 



99 

Dr. Cox. The ones that are relatively radio resistant are certain 
tumors of bone, cartilage, and soft tissues. Most of the rest are con- 
sidered sensitive or moderately radio sensitive. Some are exquis- 
itely radio sensitive — ^the leukemias, lymphomas, Hodgkin's dis- 
ease; there is a long list. The others are of intermediate radio sen- 
sitivity and require higher doses. 

Mr. Bryant. I guess my question is whether the individuals that 
were the subject of these experiments had cancer which might logi- 
cally be assumed to have been sensitive to radiation treatment, 
based upon what you knew at the time. 

Dr. Cox. The published information indicates that the studies 
were being done, the whole body irradiation and half-body irradia- 
tion studies were being done — were being done for diseases where 
the tumors were considered intermediate radio sensitivity, not ex- 
tremely radio sensitive. See, there is a gradation from extremely 
radio sensitive to pretty radio resistant, and these were intermedi- 
ate. They are curable, when local treatments — where radiations 
can be given and the tumor is only localized, so in that sense they 
are sensitive. 

You are asking a very difficult question from a radiation biology 
perspective. 

Mr. Bryant. Are colon, lung and breast cancer radio resistant or 
radio sensitive? 

Dr. Cox. When they are localized and treated with radiation 
therapy alone, they are curable. They can be eradicated perma- 
nently. When they have spread widely, the doses are usually con- 
sidered such that you couldn't give them for the whole body. 

But they were investigating that. That was exactly the subject of 
the study in the 1960s. 

Mr. Bryant. I think the logical extension of that is, would it not, 
therefore, be unreasonable to assume that perhaps whole body ra- 
diation at an acceptable level might have an impact on them if they 
had spread? 

Dr. Cox. Exactly. 

Mr. Bryant. The radiology report states that patients were not 
specifically informed that the partial financial support, this is for 
the experimentation, came from the Department of Defense. The 
patients were told that support came in part from a national agen- 
cy. 

The question of the source for support of a project is not con- 
strued by the American College of Radiology committee or most 
medical investigators as being relevant to the issue of informed 
consent. That is all in the quote. 

With the standard of informed consent, is the patient told what 
agency is funding the experiments he or she may be taking part 
in? 

Dr. Cox. They may or may not be told which agency is funding 
the experiments. I don't really believe that it is a standard part of 
most informed consent, because for clinical investigations — ^because 
the approval process is one that is independent of the funding 
source. The approval process within any institution, and in adher- 
ence with the NIH guidelines, is independent. It is in each institu- 
tion and is independent of the funding source. That is what drives 
the informed consent. 



100 

Mr. Bryant. Mr. Mann. 

Mr. Mann. Thank you, Mr. Chairman. 

Dr. Cox, my understanding of the way that the project was orga- 
nized is that the Pentagon dollars were used for laboratory work 
that had to do with the things the Pentagon was interested in. And 
patient care and cost of administering radiation and so forth were 
paid from separate sources. 

So I guess the question is, if this was an appropriate experi- 
mental therapy from a medical perspective, could it have been done 
without the Pentagon funding? In other words, if the lab work is 
purely to support what the Pentagon is interested in, why were 
they merged together; and would it have been appropriate to pro- 
ceed without any Pentagon involvement, and on the same budget? 

You wouldn't need the Pentagon dollars if my hypothesis is cor- 
rect. 

Dr. Cox. I can't really speculate on the thinking at the time. I 
can say that the support for clinical research is very meager. Even 
from the National Cancer Institute at the present time, there is an 
average of $50 per new patient diagnosed each year to support clin- 
ical research. So investigators usually either do it on their own 
with institutional support, or they may seek any number of oppor- 
tunities to get funding if such funding might be available. 

And it usually, if there is any outside support, it comes from 
multiple sources, but it only covers a very tiny amount of the cost. 
So my guess is, based both on what was going on then and what 
I know now, the experiments probably would have been done much 
as they were; maybe not all those measurements of interest to the 
Department of Defense might have been made, but I think the 
total body irradiation experiments would have been done anyhow. 

Mr. Mann. That is not the way it was done. It was done coinci- 
dentally, timewise, with the contract with the Pentagon. Obviously, 
the question that we are all struggling with is, would it have hap- 
pened without the Pentagon dollars and what was driving the re- 
search? 

Your statement closes with this sentence, "One might judge them 
harshly from a perspective of 20 years later, but they were re- 
viewed and approved by peers and directors at the time the studies 
were conducted." Are you one of those that would judge them 
harshly from a 1994 perspective? 

Dr. Cox. With the evolution of informed consent between that 
time and now, I think we would bend over backwards to be much 
more clear in what is made available to the patients and their fam- 
ilies. I think we would provide written information to them before 
they were ever asked to give informed consent to describe the ex- 
periment, and let them take such information home and discuss it 
with anyone that they wish. 

I think we would provide them with repeated opportunities to 
discuss this with anyone they wish, including the referring physi- 
cian, including any other physicians. That is pretty much the 
standard of today. 

That was not the standard at that time. And so in that sense I 
think, sure, we would not do informed consent today anything like 
what they did then, like what we did then. The half-body irradia- 



101 

tion experiments are going on right now in exactly the same way, 
with NCI funding. 

So I think there is Httle question that those would not be consid- 
ered out of the ordinary by current standards. 

The total body irradiation experiments would only be done now- 
adays with the help of bone marrow support, either bone marrow 
transplants from other individuals or from other family members 
or from the patient's own blood, or more modem techniques to use 
peripheral blood stem cells. 

So we would not undertake those studies of whole body irradia- 
tion now without having the supportive structure to assure us that 
the bone marrow would be reconstituted. But high-dose, otherwise 
lethgd, therapy is given now, now with doses far above anything 
that was given to these patients, with bone marrow rescue; and it 
is not always successful. 

And those are the nature of the clinical experiments that are 
going on. 

Mr. Mann. Some of that work now is in the experimental cat- 
egory? 

Dr. Cox. Yes, sir. 

Mr. Mann. In the later years of this project it did, as I under- 
stand, involve bone marrow transplants, typically by taking mar- 
row before the irradiation from the patient and reinserting it, 
whatever the proper term is. 

You have reviewed the ACR, American College of Radiology, re- 
port from 1972. Do you agree with what that report says? 

Dr. Cox. I have no reason to disagree. Nothing else has come to 
my attention that would cause me to change the opinion which was 
rendered by Drs. Kaplan, Hendrickson, and Taylor at that time. 

Mr. Mann. Do you have any professional relationship with Dr. 
Saenger, just for the record? 

Dr. Cox. No. 

Mr. Mann. Dr. Steger, we appreciate your presence, £ind I guess 
I want to make sure I understand exactly what the stance is of the 
University of Cincinnati today. 

Obviously, you made very clear that you are making every effort 
to be as completely forthcoming with the documents as possible. I 
think that is important. There are those in the community who are 
saying that it is appropriate for someone to say we are sorry. And 
the question is, what responsibility is the university assuming for 
a judgment today on the appropriateness of using 1960s values and 
standards of what was done at the University of Cincinnati? 

Mr. Steger. Well, there are certainly two sides of the story, 
when you read the evidence and listen to witnesses. Unfortunately, 
we are under litigation, so I really can't respond to that other than 
to say I think that the university would like to see investigations 
done — that you are doing, that outsiders are doing — ^because we are 
suspect, frankly. And so we invite you to answer that question; we 
invite other groups to study and answer the question. 

And that is the stance we are taking. I think it is the only one 
we can take. 

Mr. Mann. Thank you. 

Mr. Bryant. Mr. Portman. 

Mr. PORTMAN. Thank you, Mr. Chairman. 



102 

Dr. Cox, thank you for coming to Cincinnati. We appreciate your 
perspective as an expert on oncology and also radiation therapy 
from a very distinguished medical institution. 

I would really like to build on the earlier questions with regard 
to informed consent. I think you answered very well what today's 
standards are. I think you answered less well what the standards 
were in place at the time of the experiments. 

You said in your testimony that they seemed to have used the 
appropriate standards of informed consent, in response to questions 
from my colleague. You mentioned that you thought that standards 
had evolved significantly, as they surely have. I just wonder if you 
could fill us in a little further as to what the standards actually 
were in 1960 or in 1966, or indeed in 1971. 

Dr. Cox. Well, the standards underwent an evolution during that 
time, not only in terms of clinical experiments, such as this one, 
but in terms of what one told the patient that was being treated 
with standard therapy. 

There was literature in the early 1960s from prestigious univer- 
sities that defended the idea of not telling the patient they had 
cancer at all because it would harm them. In sophisticated institu- 
tions in other countries, that is still the standard today. 

So there was an evolution in what you told cancer patients about 
their disease and of course about their treatment. In the middle 
1960s, the National Institutes of Health quite appropriately, even 
at that time we thought appropriately, demanded, because most of 
us advocated complete honesty with patients all along, advocate 
that if they were to be involved in clinical research, that we tell 
them everything that we could about the experimental treatment 
about what they had, about what benefits they might receive, and 
about what benefits mankind might gather from such treatments. 

More and more and more, those demands have become increas- 
ingly arduous, but the basics of them were there, and it was really 
more a matter of how you documented them. And so what we told 
patients then, in my experience, was not profoundly different. 

The degree to which it was documented for the medical record 
and for such hearings as this has become far more rigorous. 

Mr. PORTMAN. With regard to whole body radiation, you spoke 
earlier about the fact that it continues to be used today at doses 
higher even than doses which were administered in this experi- 
ment. Going back to the 1960s again, which is the relevant time 
period for our inquiry, was whole body radiation at that time 
thought to actually be helpful either in curing cancer or to reduce 
the symptoms related to the cancer? 

Dr. Cox. Yes. 

Mr. PORTMAN. And that obviously would include the Ewing sar- 
coma, as you talked about earlier, and would include the cancers 
in your discussion with Chairman Bryant that are more subject to 
metastasism, spreading throughout the body, but would that also 
be true with all the cancers in this study, to your knowledge? 

Dr. Cox. No. I don't think I could answer yes to the fact that 
they would — that that would be considered the standard at the 
time. That was what was being experimented. What was done, 
standard treatment, was mostly with leukemias, lymphomas, espe- 
cially chronic leukemias, acute leukemias of childhood. 



103 

The other types of cancers, such as total body irradiation would 
be considered investigational. 

Mr. PORTMAN. With regard to the doses that were given in the 
1960's, do you believe that those were at the appropriate level? You 
had mentioned earlier some levels that you deemed to be nonlethal 
versus lethal. 

In your study of this matter, do you believe the doses given were 
appropriate? 

Dr. Cox. The doses given, I believe, were probably selected be- 
cause they were the highest doses that could be given without bone 
marrow support, as I described, that would not be lethal. So the 
doses that were administered that I have read would be considered 
sublethal. 

But they were as high as one could hope to achieve for tumors 
that were not exquisitely radio sensitive. So it seems to me that 
they were reasonable doses for the experiments that were done. 

Mr. PORTMAN. Thank you, Dr. Cox. 

Mr. Steger, again, thank you for being here today. Earlier, we 
heard from Gloria Nelson that her grandmother's name may not 
have been correctly signed. In other words, it might not have been 
her grandmother's signature on some of the forms. 

I have not had an opportunity to look at all the patient records. 
I understand those records have now been released to family mem- 
bers that have been identified. 

But do you have any procedure in place to be sure there is not 
any tampering with the existing records, such as they are? 

Mr. Steger. Yes. We have formed a particular group that are 
now the custodians of all the records surrounding the whole body 
radiation studies, and they are now kept in one place under lock 
and key and only one individual, myself, essentially can release 
those. So that I would hope that they are currently very well pro- 
tected. 

Mr. PORTMAN. University Hospital is a teaching hospital, a re- 
search hospital, well-known throughout the country. It seems to me 
one of your jobs is to provide information, research, data, and so 
on, to agencies like the Department of Defense from time to time. 

You have another job, which is to treat patients. And I guess my 
general question for you is whether in looking at the facts in the 
record from 1960 to 1971, the then General Hospital, do you think 
that General Hospital became too concerned with the providing of 
information and not concerned enough with the treatment of the 
patients at the time? 

Mr. Steger. Well, again, since we are under litigation, I can't 
answer that question. 

Mr. Chesley. Let me just volunteer as a former chairman of the 
board of the university. There has been, just as Dr. Cox has talked 
about, an evolution. The evolutionary aspect of the university, since 
the days when it was Cincinnati General Hospital, under the city 
of Cincinnati as a municipal university, has been a miracle as far 
as evolution. 

I am not taking anything away, but from my role as chairman 
of the board for 5 years and on the board of trustees for 9 years, 
just what I saw as far as the movement forward toward the 21st 



104 

century relative to that institution and the medical complex has 
been phenomenal. 

It is very, very difficult to compare back, Congressman Portman, 
and I think it is an excellent question, it is almost impossible to 
compare back to what it was like in the 1960s as far as a teaching 
university, which it was, as compared to today, where it is one of 
the real crown jewels in this community and a crown jewel region- 
ally as one of the finest medical complexes in the country, irrespec- 
tive of the fact that we are in litigation, the university is in litiga- 
tion. 

I think it is very significant that here is a defendant, I am usu- 
ally on the other side, a defendant in litigation coming forward, 
which we have, the university in the last month or so, and put all 
of the documents forward on a volunteer basis when it was not in 
any way required, because I believe. Dr. Steger believes that that 
is the role of this teaching university, which is that information 
which we have, at least from an archives standpoint, must go for- 
ward to the public and be put. 

In response to the question on the signature, we will look into 
that because all of the patient records are on microfiche, so if there 
is a different signature on that medical record of those unfortunate 
individuals that would have been contemporaneous when that doc- 
ument was put on microfiche. And we want to take a look at it. 

I am glad — I forgot which one of the women it was — brought it 
forward to our attention so we can take a look at it and find out 
what the facts are. 

Mr. Portman. Thank you for that commitment and thank you for 
that explanation. 

I really have no further questions. 

Thank you, Mr. Chairman. 

Mr. Bryant. Dr. Steger or Mr. Chesley, either of you who wish 
to respond, one of our purposes, of course, our essential purpose in 
this hearing, is to determine if we have inherited responsibility for 
actions that might have been illegal or wrong from the previous 
generation of leadership, that require us, in order to show good 
faith, to compensate people for damage that might have been done 
to them. 

It would be helpful if you could tell us the nature of the litigation 
you are involved with right now. 

Mr. Chesley. Let me respond. I have purposely stayed out of any 
aspect of the litigation. I happen to be, by job description, an attor- 
ney, but in this role I am an adviser, I like to call myself his assist- 
ant. 

We, the University of Cincinnati, has been sued in a number of 
cases, I believe there are presently pending three class actions, 
none of those classes have been certified, and a class action, as you 
know, Mr. Chairman, means that there are lawyers who are sug- 
gesting that they represent all of the victims and all of the claims, 
and that may very well end up being. 

So the way we are looked at it in the university is that the Uni- 
versity of Cincinnati at present is a defendant on behalf of every 
person, whether they have individual counsel or are a participant 
as part of a class. So theoretically, that is 88 claims against the 
University of Cincinnati. The same claimants have also brought 



105 

lawsuits against Dr. Saenger, he and his counsel can speak about 
that, and the other 8 or 10 physicians and professionals who were 
part of that original team. 

That litigation is presently pending here in the United States 
District Court. I believe it is three separate lawsuits, if that is of 
help to you. 

Mr. Bryant. And what have they alleged? 

Mr. Chesley. They have alleged violation of — and I think one of 
the — two of the plaintiffs' lawyers are here. They can probably 
speak clearer about it. As I say, I am not counsel for the university. 
It is my understanding that they have alleged violation of civil 
rights. They have alleged violation of medical malpractice claims 
and sundry other claims of conspiracy, fraud, and so forth that are 
all encompassed. 

One of the significant claims bringing it into the Federal Court 
was the violation of the individual's civil rights. 

Do I not know — and maybe counsel can speak as to whether or 
not the Department of Defense is presently a defendant in those 
lawsuits. I would ask if you would speak to one of the attorneys 
that are here and they could — I know there is someone here, I 
know Mr. Newman is here. He represents some of the plaintiffs, 
and he is seated right behind some of the people that testified, and 
maybe they could give you more specificity or in the alternative, I 
think the best thing to do is to see to it that we get this panel a 
copy of the present lawsuits that are pending, we can get that for 
you today. 

Mr. Bryant. Obviously my wheels are turning about whether or 
not these individuals are going to receive the most thorough pos- 
sible hearing in a Federal courtroom, and therefore, having this en- 
tire matter adjudicated without this committee having to look at it. 

Mr. Steger. I believe what you and Congressman Mann and 
Congressman Portman are doing is very, very important. It may 
have other issues over and above when a lawsuit will or will not 
be heard what the facts are, and an opportunity to have all sides 
aired. 

Unfortunately, litigation, while it is very, very complete, in the 
final potential resolution, it is slow in going forward, and these are 
issues that I think you are bringing together with President Clin- 
ton's admission that are issues that I think are important for the 
university to be brought forward. 

I think it is very important for us to be able to say, we are here 
to cooperate irrespective of the litigation, irrespective of the law- 
suit, and we will continue that cooperation with Congress, the 
interagency commissions. President Clinton's commission. 

Mr. Bryant. Very well. 

Finally, Dr. Cox, the severest critics of this entire matter re- 
main — the ones on the next panel are those who have been critics 
for a very long time. I am looking at the peer reviews that took 
place here and wondering, how should we view these peer reviews 
of the actions of 20, 30 years ago? 

Are they dispositive of the issues of responsibility here? Should 
they be read as a clear approvgd of what went on in terms of hav- 
ing given the patients adequate information, and any other ele- 
ments of responsibility or not? 



106 

Dr. Cox. I can say that I believe the only way of being fair is 
to judge them by the standards of the time, not the standards of 
today. To do otherwise would be to treat them unfairly. 

To judge cancer treatments of the time by the stsmdards of today 
would be to judge them unfairly. We have evolved. Medicine has 
evolved and the process of informed consent has evolved. 

Mr, Bryant. You mentioned the studies reviewed by the Faculty 
Research Committee of the Cincinnati University College of Medi- 
cine. 

I think it is fair to say we might set that aside, inasmuch as they 
are, I would think, an interested party. 

Dr. Cox. I would take exception to that, sir. I believe that that 
is the title for what we would now call the Institutional Review 
Board, and that that is a standard part of the review process. 

As a matter of fact, key to the review process to this day. So I 
was interpreting that as being a specific term for the general term 
of what we would call the IRB or Institutional Review Board, and 
that is absolutely critical to this, but the standards have changed 
relative to the IRB today relative to what they were then. 

Mr. Bryant. I agree we should stick to the standards at the time 
in judging everybody's intent at the time. You say they were also 
reviewed by the National Institutes of Health. We have now found 
that apparently they refused to participate in this. Is that relevant? 

Dr. Cox. I took that from the footnote to Dr. Saenger's paper of 
1973, where it said that this was supported in part by the Depart- 
ment of Health and Human Services. I don't know any other agen- 
cy that would have supported it in whole or in part except NIH at 
that time. 

Mr. Bryant. What do you mean by support? 

Dr. Cox. I 

Mr. Bryant. You mean help pay for the research? 

Dr. Cox. I assumed that is what it meant. Is it possible that the 
NIH approved and supported this for a period of time and then 
withdrew its support? 

I don't know the answer to that, but I was just going by what 
was included in the publication. You will have to ask others. 

Mr. Bryant, We are asking others, but this reference that you 
made on page 4 of your testimony, and is in the list of things which 
you characterize as peer review. 

My question is, if this matter underwent peer review by the Na- 
tional Institutes of Health, it is a fair question for us to ask how 
it could be that they did not participate. There is indication they 
didn't participate, and at the same time came back and gave this 
a clean bill of health in the peer review process. 

Dr. Cox. I made that statement based on this quote from Dr. 
Saenger's paper of 1973: "Supported in part by USPH RR-5408, 
NIH General Research Support Grant of the College of Medicine in 
Cincinnati," Maybe the grant was through the University in a 
broad sense and not specifically to this project. But it would have 
undergone review by NIH as a part of the review of the University 
of Cincinnati's grant from NIH, 

Mr. Bryant. Have you seen a review of this that went back to 
judge whether or not it was handled in a proper way? 

Dr. Cox. No. 



107 

Mr. Bryant. So I wonder if it is appropriate that you list it 
under peer review in your testimony here. Perhaps you are just as- 
suming they would have reviewed it if they had a role in it, and 
now we doubt that they even had a role in it. 

Dr. Cox. I am just taking it from the publication that is — that 
is where that came from. I took it from the quote in the publication 
by Dr. Saenger's report, Dr. Saenger and colleague's report from 
1973. 

Mr. Bryant. Let's go to the one conducted by the American Col- 
lege of Radiology at the request of Senator Gravel in 1972. 

Would that have taken place over the telephone? Would that 
have been everybody exchanged written data and read it over in 
their office, or would that mean a visit to Cincinnati? What would 
that mean? 

Dr. Cox. From the report that I have, which I really only have 
two documents that serve as background for this, one is Dr. 
Saenger's paper, the one is the report from Drs. Kaplan, 
Hendrickson and Taylor, through the American College of Radiol- 
ogy, to Senator Lavelle. 

In that report, they indicate that they first had a preliminary 
meeting in Chicago, and after that paid a site visit to the Univer- 
sity of Cincinnati and reviewed records, discussed with a wide vari- 
ety of people here, and did that which we would consider standard 
for a site visit today and they did it in the context, as they wrote, 
of what they would consider a study section or a peer review at 
NIH at that time. 

So they were approaching it as if they were peer reviewers, as 
they would review any grant that had been submitted to them for 
review at NIH. They were all experienced reviewers. So they both 
reviewed the documents and they paid a site visit. 

Mr. Bryant. Any further questions? 

I would like to thank all the panelists, particularly Dr. Soper and 
Dr. Cox who traveled a long way, and Dr. Steger and Mr. Chesley 
for taking your time in coming forward and helping us in this in- 
quiry. 

Thank you very much. 

At this time, the committee would invite the third panel to come 
forward, which consists of Dr. David Egilman, clinical assistant 
professor. Department of Community Medicine, Brown University; 
and Dr. Martha Stevens, professor of English at the University of 
Cincinnati. 

We thank both of you for being here today. As with the other wit- 
nesses, we ask you to hold your opening statement to five minutes 
so that we might go right to the questions. 

We will start on the left of the committee. Dr. David Egilman. 

STATEMENT OF DAVID EGILMAN, M.D., CLINICAL ASSISTANT 
PROFESSOR, DEPARTMENT OF COMMUNITY MEDICINE, 
BROWN UNIVERSITY 

Dr. Egilman. Chairman Bryant, committee members, thank you 
very much for inviting me here. I am a private physician, practic- 
ing in Braintree, MA. I am on the faculty at Brown University. 



108 

I teach a course on the development of medical and scientific 
knowledge and history of the 20th century that includes the issue 
of the development of ethical standards during that time. 

For 10 years or so, I have been trying to get the research funded 
by our Grovemment on its own citizens that was performed here 
and at other institutions for purposes of military research inves- 
tigated. I appreciate this opportunity today. 

I want to begin first by responding to a question that was asked 
of the previous panel. Dr. Cox was asked whether or not he could 
find confirmatory evidence of informed consent in the 1973 paper. 
Well, there is some evidence on page 678. 

It says. 

The acute radiation S5aidrome develops in stages. In the prodromal stage, nausea 
and vomiting of a transient nature ocoir. These complaints are not discussed with 
the patient before treatment. 

The comments I make are not a retrospective look at the 1960's 
by 1970's standards or 1980's standards or 1990's standards. They 
are rather a look at the 1960's and 1970's by the standards of the 
1890's, the 1940's, and the 1950's. As I begin with comments of 
physicians who reviewed this research for the University of Cin- 
cinnati, on the faculty of the University of Cincinnati, at the time 
the work was going on, that will be clear. 

Dr. Gall, first in 1966, in a letter, stated that the informed con- 
sent form was inadequate. Dr. Shields, also writing about the in- 
formed consent form, in 1967, wrote "I believe a 25 percent mortal- 
ity is too high." He also made a small comment about the adequacy 
of the therapy for cancer. "All patients should be informed not only 
that a risk exists, but of a one in four chance of death within a few 
weeks of treatment." 

Evel3ni Hess, writing in 1969, stated "The acceptability of our 
general consent form for human volunteers participating in re- 
search was questioned." 

Dr. Thomas Gafihey, in 1967, wrote: 

The applicants have apparently already administered 150 to 200 rads to some 18 
patients with a variety of malignancies and to the researcher's themselves' satisfac- 
tion, have not found a beneficial effect. In fact, as I understand it, they found con- 
siderable morbidity associated with this high dose of radiation. Why is it now logical 
to expand this study? Its current design will not yield meaningfiil data. The study 
should not be done. 

Dr. Gaffney was on the faculty of the University of Cincinnati re- 
viewing these experiments. But the ethical standards were known 
and established long before, with reference to this type of an exper- 
iment. 

In 1950, Dr. Hamilton wrote describing similar work to Dr. 
Shields Warren, and said that this type of experiment had a little 
bit of the Buchenwald touch. 

My father was at Buchenwald. I can assure you by 1950 it was 
well known what it meant to say that an experiment had a little 
of the Buchenwald touch. 

The subjects were uneducated, had poor education, low IQs, and 
many had brain dysfunction because of their disease. They were 
unable to give informed consent. Rose Strom was diagnosed as re- 
sectable sarcoma in April 1970. She received a course of chemo- 
therapy. 



109 

Chemotherapy was given for colon cancer in this time period. It 
was and still is to date palliative therapy for colon cancer. She was 
readmitted to the CGH on December 14, 1970. 

According to Mrs. Strom's records, at 2 p.m. on that date, she re- 
ceived 10 milligrams of morphine IM, intramuscularly. Also at 2 
p.m. she signed a consent form for radiation. She was then irradi- 
ated. 

This was immediately followed by nausea and vomiting that 
lasted for 3 hours. She vomited repeatedly for 3 days. Antinausea 
medicine was withheld until the staff noted she was depressed to 
the point of crjdng and that she said, "I am so sick." 

Withholding therapy for nausea and vomiting is not then nor is 
it now part of normal cancer treatment. 

The researchers knew that informed consent was the standard of 
the day. As you have heard in the paper we read, they claimed 
they received informed consent. Despite that fact, only six of the 
first three patients received any information on the nature of the 
experiment, and none were informed of possible risks. If their pub- 
lished papers correctly report their failure to advise their patients 
about the possible experimental risks, their stated conclusion that 
they received informed consent is surely wrong. 

Tlie researchers were aware of informed consent requirements. 
They said they met the informed consent requirements of the Hel- 
sinki Code published in 1962. Similar experiments were rejected by 
one of the researcher's colleagues and when advised of the research 
in 1966 when it was suggested that the same thing be done at Oak 
Ridge University. 

Oak Ridge researchers said, we are hesitant to treat these can- 
cers because we believe there is so little chance of benefit to make 
it questionable ethically to treat them. Lesions that require mod- 
erate or a high dose of local therapy for benefit or are actually 
radio-resistant such as gastrointestinal cancer, just to help Dr. Cox, 
are not helped enough by total body irradiation to justify the bone 
marrow depression that is induced. 

The argument that these experiments were appropriate from the 
ethical standards of the 1960s lack both scientific and historic accu- 
racy. 

In addition, cancer therapy was not the purpose of this research. 
Previous research had already been done. In 1942, it was pub- 
lished, "Little or no benefit follows its use," that is radiation, whole 
body radiation, "in the treatment of generalized carcinoma or sar- 
coma." 

That is the kind of cancer in this study. "In no patient was there 
evidence that total body irradiation afiected disease, 1965." In the 
kinds of cancers in this study. 

Cancer therapy was not the purpose of the research. The re- 
searchers themselves described the purpose of the research: "To 
provide knowledge of combat effectiveness of troops." In real medi- 
cal research, in real therapy, treatment for nausea and vomiting is 
provided. In military research in the U.S. experiments, it was de- 
nied until the patients had severe nausea and vomiting. 

In real research, in real cancer therapy, psychologic and peer 
counseling is provided. In this work, in this military research, in 



110 

these U.C. experiments, patients were intentionally psychologically 

isolated. ,. . . . 

In real medicine, in real radiation therapy, the radiation is given 
slowly and from many directions to improve effect and reduce side 
effects. In military research, in these experiments, the radiation 
was given fast and unidirectional, in the words of the researchers, 
because that was the radiation of military interest. 

On February 9, 1971, Mr. Willard Larkins was noted to either 
have a lymphoma or adnocarcinoma of the colon. According to the 
hospital notes written by Dr. Aron and Dr. Rau, if he had a 
lymphoma, radiation would be indicated, while if an adnocarcinoma 
chemotherapy would "probably be in order." 

On February 19, Mr. Larkins was found to have adnocarcinoma 
and Dr. Rau said, "Radiotherapy was definitely out of the picture 
and the patient may be a candidate for 5FU." 5FU is chemo- 
therapy. 

Five days later, he got the radiation. He never got the chemo- 
therapy. There were four or five informed consents signed in Mr. 
Larkin's chart for surgical procedures. There was no informed con- 
sent signed for radiotherapy like this. 

This was 1971, well into the period where people claim all the 
patients signed informed consents, well into the period when people 
claim the standard was a signed informed consent should be given. 

Who was responsible? I think we find here we still have a prob- 
lem. The fact that the representatives of the ACR, admittedly ap- 
parently from an institution that did similar work, could still come 
here and claim that this work was appropriate means that we have 
a problem in the medical community in this country. It is a prob- 
lem that is a current problem. It is not an old problem. 

The fact that there is an attempt to let you think that this was 
in some way not previously found to be inappropriate therapy 
means we have a problem in this country. 

It is in the medical community. The fact that the University of 
Cincinnati's report reported almost everything I said and then said 
they had no problem means that there is a problem at the Univer- 
sity of Cincinnati and at other universities. The fact that NIH de- 
nied the funding and then didn't tell anybody it was because of eth- 
ical reasons means we have a problem. 

Thank you. 

Mr. Bryant. Thank you. 

[The prepared statement of Dr. Egilman follows:! 



Ill 






BROWN UNIVERSITY Division of Biology and Medicine 
Department of Community Health 



Statement to Congress, Subcommittee on Adminlstative law and Governmental Relations, April 
11, 1994 by David S. Egilman MD, MPH, 759 Granite Street, Braintree, Massachusetts. 

Chaimian Bryant, Subcommittee Members, Good Afternoon 

My name Is David Egilman. I am a physician. I am primarily a practicing doctor in Braintree, 
Massachusetts. I am also a member of the faculty at Brown University. In that role I teach and 
conduct research on the history of the development of medical knowledge in the 20th century. 

I want to thank the SutKX)mmittee for inviting me here to speak. For almost ten years I have 
tried to raise my voice at>out some of the experiments conducted by our Government on its own 
citizens, and I am grateful for this opportunity today. 

I would like to t>egin by reviewing some contemporaneous comments of the colleagues of the 
University of Cincinnati (UC) researchers. There is little that I can add to these, however some 
still defend these experiments so I will endeavor to explain the bases of the criticisms later in my 
comments. 

•tt is not certain from the [consent form} narrative whether the patient is advised that no specific 
benefit will derive to him and that there are, indeed risks involved in the procedure proposed." - 
Edward Gall MD, May. 1966 

*l believe a twenty-five percent mortality is too high.' All patients should be informed not only 
that a "risk exists" but of, "a 1 in 4 chance of death within a few weeks' of treatment - George 
Shields MD, 1967 

The applicants have apparently already administered 150-200 rads to some 18 patients with a 
variety of malignancies and to their satisfaction have not found a beneficial effect. In fact, as I 
understand it, they found considerable morbidity associated with this high dose of radiation. 
Why is it now logical to expand this study? 

Even if this study Is expanded, its current design will not yield meaningful data. ... It will be 
difficult if not impossible to observe a beneficial effect in such a small sample containing a 
variety of diseases all of which share only CANCER in common. 

This gross deficiency in design will almost certainly prevent making meaningful observations. 
When this deficiency in experimental method is placed next to their previously observed poor 
result and high morbidity with this type of treatment in a 'variety of neoplasms' I think it is clear 
that the study as proposed should not be done. 

I have the uneasy suspicion, shoed up by the revised statement of objectives, that this revised 
protocol is a sutrterfuge to allow the investigators ... to test the ability of autologous marrow to 
lake' in patients who have received high doses of total body radiation. This latter question may 
be an important one to answer but I cani justify 200 rad total body radiation simply for this 
purpose, 'even in terminal case material'. - Thomas Gaffney MD - 1967 

...the acceptability of our general consent fonm for human volunteers participating In research 
was questioned' - Evelyn Hess MD - 1969 commenting on the reason for rejection of two grant 
applications by the National Institutes of Health. 



Box G, Brown University, Providenc^ Rhode Island 02912 •Tel. (401) 863-3172 



112 



In my statement I will cover four areas. 

1 . What were the experiments? 

The whole body radiation (WBR) experiments conducted at the University of Cincinnati (UC) 
wereTilgaS to provide information to the military. They were not in any way cancer treatment 
or palliation. Some of those studies resuKed in the deaths of their subjects. 

2. Were the experiments conducted according to the ethical standards of their time? 

The answer to this question is a firm no. 

3 Why did these experiments occur and continue over a considerable period of time? 

Why did it take until 1994 for these activities to reach the national consciousness? 

There was a lack of oversight and we are all responsible. 

4. We must do our best to right past wrongs and prevent this from happening again. 

I would aigue that this necessitates taking several long and short-temi steps, including the 
following: 

A. We must document and assess what happened. 

B. Those hamied should receive compensation. u ^ ^ ^mnoHw 

C Appropriate actions should be taken against researchers who acted improperly. 

D. we rSS establish pemianent mechanisms to assure that this type of expenments will not 
occur again. 

in mv oDinion they could occur again, they may occur again, and we need to establish a system 
S ZZZ b JanSs to assure that hearings such as these are not held again. Never again. 



113 

The University of Cincinnati Experiments 1961-1972 

A. Ethics and Infomoed Consent 

On November 28, 1950, Dr. Joseph Hamilton wrote a letter to Shields Warren MD, Director 
Division of Biology and Medicine, The Atomic Energy Commission (AEC) conceming the ability 
of irradiated soldiers to function. (AEC) researchers wanted to determine the dose that might 
limit a soldier's "capacity to execute intricate tasks for which physical well being is essential." He 
discussed the difficulties of perfonming such a research study, and suggested that "For both 
politic and scientific reasons, ... it would be advantageous to secure what data can be obtained 
by using large monkeys such as chimpanzees which are somewhat more responsive than lower 
mammals." If the research was to be done on humans, Dr. Hamilton predicted that "those 
concerned in the (AEC) would be subject to considerable criticism, as admittedly this would 
have a little of the Buchenwald touch... The volunteers should be on a freer basis than inmates 
of a prison. At this point, I haveni any very constructive ideas as to where one would tum for 
such volunteers should this plan be put into execution." 

Despite Hamilton's "political" sensitivity to a possible adverse public reaction to this research, the 
DOD funded studies similar to those described in his letter. Eugene Saenger MD and his fellow 
researchers at the University of Cincinnati conducted these experiments between 1960 and 
1971. In all researcher irradiated 88 cancer patients during those years. Dr. Saenger and 
coworkers published some of their findings in 1969 in the Archives of General Psychiatry. The 
article was titled, "Total and Half Body Irradiation, Effect on Cognitive and Emotional Processes." 

Cancer therapy was not the purpose of this research. Recently some defenders of this work 
have stated that the experiments met the ethical standard of their day. This is not true. 

As they say, the devil is in the details. In their 1969 paper the researchers stated, that 
preirradiation analysis of the experimental subjects revealed that the researchers would have 
had difficulty in obtaining true informed consent from the study participants. "Relevant 
intellectual characteristics of the patient sample were as follows: a low-educational level (ranging 
from 63 to 1 12 on the full-scale of the Wechsler-Bellevue which has a mean of 84.5), and a 
strong evidence of cerebral organic deficit in the baseline (preradlation) measure of most 
patients." Thirteen of sixteen subjects were "Negro," three were White. 

These researchers like others involved in similar experiments funded by the DOE and NASA, 
selected the most vulnerable of our citizens as subjects, the poor, the mentally and emotionally 
Impaired, and African-Americans. UC researchers knew or should have known that their patient 
population was incapable of giving informed consent even if had they were infonmed of the 
experimental risks (which they were not). The UC researchers did not give the subjects all the 
facts on the side effects of the radiation. Therefore, if the patients consented to the experiments, 
the consent was not informed. According to the UC investigation of this research (Suskind report) 
a review of 27 of 33 patient charts between 1 960-1 964 did not contain any notation that the 
patients were informed about anything. Six of the patient charts contained infomnation 
indicating that the patient "was infomed about the nature of the treatment and its possible 
benefrts." The patient charts did not contain any notation on the risks of the experiments. It 
must be assumed from comments of relatives of survivors and the lack of notation that 27 of 33 
patients received little or no information of the risks. The researchers own contradictory 
statements about infonmed consent provide the best evidence that they violated the ethical and 
moral standards of both the sixties and the nineties. 

UC researchers in their 1969 research paper revealed these contradictory elements themselves. 
The report included both of the following statements: "In each case the patient was advised that 
the therapy might be beneficial to him but that it was experimental in nature. Infomied consent 
was obtained in all cases." And, There was no discussion with the patient of possible 
subjective reactions resulting from the treatment. Other physicians, nurses, technicians and 



114 



ward personnel were instructed not to discuss post irradiation symptoms or reactions with the 
patient This precaution was carefully followed so as to standardize and minimize iatrogenic 
factors' in influencing whatever subjective reactions the patients might have to radiation^ 
Iatrogenic means doctor induced. The researchers claim they did not tell the patients about the 
Double side effects because this information could have induced nausea and vomiting in the 
patients This is further evidence that the study was a study of the side effects of radiation not of 
the treatment of cancer. It is obviously impossible to obtain informed consent without giving 
information on the side effects of the treatment. 

In response to a junior faculty report critical of the research, the UC researchers claimed that 
thev had informed the patients of the risks involved and the possibilities of complications. They 
even produced a consent form allegedly used and signed by every adult patient in the study from 
1 965 onward However, in addition to the detailed infomiation on the lack of infomfied consent 
presented in the 1 969 paper a 1 973 publication that outlined the study methods stated 
specifically that the researchers did not tell the patients of the severe nausea or vomiting that 
could result from therapy. The researchers clearty understood that informed consent 
represented the standard of the day. They felt obligated to include a statement on infonned 
consent in the paper they published. Did they lie about receiving informed consent from the 
patients when the story broke or did they lie about not giving them infomnation required to 
receive informed consent in their published papers? If their published papers correctly report 
their failure to advise patients about the possible experimental risks, their stated conclusion that 
they received informed consent is surely wrong. Having failed to provide informed consent 
(how could their patient population possibly give infomfied consent?) they had to lie about it 
when the experiments became public. There is no better evidence that they violated their own 
and our own ethical and moral standards. 

The researchers were so aware of the importance of infomned consent that they stated they 
received it from the participants in the experiment even though it is clear they did not. 

in 1966 Saenger and Lushbaugh (in charge of studies of WBR at Oak Ridge funded in part by 
NASA) combined the results of their WBR research and published a joint paper. The paper 
reported the amount of radiation it took to kill half of the recipients. That same year, a review 
panel of the AEC suggested that Oak Ridge conduct experiments similar to those conducted by 
UC researchers. In reviewing a suggestion that patients with carcinoma of the breast 
gastrointestinal tract, and urogenital tract should be treated by total body irradiation the panel 
made the following statement: "These groups of patients have been carefully considered for such 
therapy and we are very hesitant to treat them because we believe there is so little chance 
of benefit to make it fluesfjonaWeemicaH^ to treat them. Lesions that require moderate 
or high doses of local therapy for benefit, or that are actually resistant (gastrointestinal 
tract) are not helped enough by total body irradiation to justify the bone marrow 
depression that is induced. Of course, in one way these patients would make good subjects 
for research because their hematologic responses are more neariy like those of normals than are 
the responses of patients with hematologic disorders." (Emphasis added) The argument that 
these experiments were appropriate from the ethical standards of the 1 960-s lacks both saentific 
and historic accuracy. 

In their 1967 report to the DOD, UC researchers said that they followed ethical standards as set 
forth in Declaration of Helsinki. Again, this is not true. The Declaration cleariy states: 

I (4) Every clinical research project should be preceded by careful assessment of 
inherent risks in comparison to foreseeable benefits to the subjects or to others. 

III. (2) The nature, the purpose and the risk of clinical research must be explained to the 
subject by the doctor. 



115 



III. (3) ...the responsibility for clinical research always remains with the research worker 
it never falls on the subject, even after consent is obtained. 

There is no question that the research failed to meet the ethical standards of the late 1940's as 
expressed in the first part of the Nuremberg code. "The voluntary consent of a human subject is 
absolutely essential." The code states that the subjects must have sufficient understanding of 
their situation, and must be capable of making an informed decision as to their participation in 
the research. The research conducted by UC researchers did not meet this standard 
established for prisoners of War. 

Informed consent was the ethical standard of Dr. Saenger's day, and was the medical standard 
since the 1890s. On April 8, 1899, an editorial In the Journal of American Medical Association 
asserted that the rule of conduct In this matter is for the physician to put himself in the patient's 
place with all his natural feelings and desires. Even consent on the part of the subject can not 
justify an experiment that needlessly puts his health or life in peril, or diminish the 
responsibility of the one who performs or permits it." (Emphasis added) 

The legal importance of informed consent was established in 1914, when Justice Cardozo wrote 
that, "Every human being. ..has a right to determine what shall be done with his own body and a 
surgeon who performs an operation without his patient's consent commits an assault for which he 
is liable in damages." Schioendorf v. Society of New Yoric Hospital . 21 1 NY 125 (1914). 

The courts again cleariy stated the standard of informed consent in 1960. This decision stated 
that, "A man is master of his own body .... A doctor may well believe that ... treatment is 
desirable or necessary, but the law does not permit him to substitute his own judgment for that of 
the patient by any form of artifice or deception." Natanson v. Kline . 350 P 2d 1093 (Kansas 
1960). Deception is precisely what occurred. The patient is told that he is to receive treatment 
to help his disease," wrote the authors in another DOD report, despite the fact that they selected 
patients with non-treatable cancers for the experiments. The researchers denied some of the 
patients potentially effective treatments. 

The human experiments which Dr. Hamilton discussed in his 1950 letter, and which Dr. Saenger 
designed in Cincinnati, were an atrocious example of medicine gone wrong. 

B. Cancer therapy was not the purpose of this research. 

Researchers tested the efficacy of whole body irradiation in the 1930's-50's at several centers, 
including Memorial-Sloan Kettering in New Yortc City. WBR was not useful in the treatment of 
solid tumors. Researchers found that the so-called "non-radiosensitive cancers" such as those 
that UC researcher irradiated, were unresponsive to whole-body radiotherapy. The medical 
utility of this study was suspect and disguised, and as a result the research resulted in the deaths 
of at least eight, and probably more than twenty of the participants. 

In a separate article titled "Whole Body Radiotherapy of Advanced Cancer," Dr. Saenger et al., 
wrote, "If one assumes that all severe drops in blood cell count and all instances of hypocellular 
or acellular marrow at death were due only to radiation and not influenced by previous therapy, 
then one can identify 8 cases in which there is a possibility of the therapy contributing to 
mortality.' Suskind states that up to 19 may have died as a result of the radiation. 

In 1905, Dessauer first used irradiation of the entire body for purposes of the experimental 
therapy of disease. Physicians used whole-body irradiation for treatment of a wide variety of 
benign conditions including asthma, migraine, and arthritis (Scott 1940) reports of adverse 
effects from radiation (Brues 1955, Furth and Lorenz 1954) quickly narrowed the use of the 
treatment to metastatic tumors. 



116 



Physicians conducted a set of clinical trials of whole-t>ody irradiation for cancer out at Memorial 
Sloan-Kettering in New York from 1931 through the 1940"s. These trials involved high total dose 
irradiation given over a period of days. Physician designed the low-dose rate irradiation to 
minimize side-effects such as radiation sickness and bone marrow suppression. Low-dose rate 
irradiation exposed the cancer ceils to radiation during the entire cycle of cell division in order to 
irradiate each cell at the most vulnerable stage in its division. Physicians published progress 
reports of the experiments performed at Memorial in 1932, 1934, and 1942. The reports were in 
agreement with other literature from that time. The technique of whole-body irradiation showed 
some promise with leukemias and lymphomas, but 'little or no benefit follows its use in the 
treatment of generalized carcinoma or sarcoma .' (Emphasis added) (Medinger and Craver 
1942). In the same study, Medinger and Craver explained why the therapy did not woric on 
carcinomas (the type of cancer selected for the UC experiments): "The results in these 
generalized carcinoma cases were discouraging. The reason for this is quicldy apparent. 
Carcinomas are much more radioresistant than lymphomatoid tumors, and by total body 
irradiation the dose cannot be neariy large enough to alter these tumors appreciably.' The reason 
the dose cannot be large enough is that a dose that will kilt the tumor will also kill the patient. 

Later studies found similar results. Jacobs and Marasso reported in 1965 on 52 patients treated 
with whole-body irradiation when 'other modalities had failed or could not be employed.* They 
found that in patients with radioresistant tumors, ' In no patient was there evidence that total-body 
irradiation affected the disease .' (Emphasis added) In contrast to the Memorial Hospital studies, 
these studies administered the radiation at higher doses, and much more rapidly. 

Interestingly Dr. Aron, one of the UC researchers and a member of the UC committee that 
investigated the appropriateness of this work in the eariy 1970's, recently stated, "In Cincinnati, 
the patients' disease had spread throughout their bodies, and most were given a life expectancy 
of six months. The effect of the study was a short prolongation of their lives. All who had the 
treatment have died of their cancers. They lived an average of fifteen months after the radiation 
exposure.' If this was therapy and it worked, why did the researchers stop it when it became 
public? Did the researchers stop the experiments because they became public? If the radiation 
did not help, the subjects, who lived an average of 15 months after being irradiated, were not 
really suffering from terminal cancer. They were not. The researchers reported that until they 
were irradiated most of the patients were in, "relatively good health." Suskind's report indicated 
that the researchers excluded tenminal patients from the study, 'Some of the reasons for patient 
rejection included advanced stage of malignancies leading to disorientation, stupor, and/or 
coma, and temriinal advanced malignant disease in which the life expectancy was only a few 
weeks.* (pg. 27) At least nine and probably more than twenty subjects died as a result of the 
experiment. 

The studies at the University of Cincinnati began and continued after the medical literature 
cleariy reflected that whole-body irradiation was inappropriate. UC researchers knew about the 
acute and chronic toxicity of whole-body irradiation; they knew that only leukemias and 
lymphomas responded to the treatment; they knew that radioresistant tumors would require a 
dose that would be lethal to the patient in order to affect the tumor. In the literature review of the 
paper by UC researchers in 1973, the authors cite the study by Medinger and Craver, and note 
that thirty-five patients with advanced carcinoma and sarcoma were included in this series*. UC 
researchers preferentially selected patients with tumors that were not treatable by whole-body 
irradiation (cancer of the colon, breast, and lung) and then told the patients that they would 
receive therapy for their disease. 

It is important to note that the ill-effects of successful irradiation consist of symptoms from the 
radiation and from the widespread destruction of the tumor cells (which release cellular 
chemicals and cause symptoms from the body's effort to remove the dead tumor cells). 
Irradiating patients with radioresistant tumors allowed the investigators to state that the 
symptoms the patients experienced were caused by the radiation and not by the effects of tumor 
destruction. This is the reason the patients with radioresistant tumors received high dose rate 



117 



irradiation. The experiment mimicked the effects of nuclear war on soldiers. The purpose of the 
experiments was as described in the researchers reports to the Department of Defense, These 
studies are designed to obtain new information about the metabolic effects of total body and 
partial body irradiation so as to have a better understanding of the acute and subacute effects of 
irradiation in the human.. ..The long-term program envisions carrying out the various 
observations at dose levels of 100 to 150, and 300 rad. Eventually doses up to 600 rad are 
anticipated.' These doses were potentially and were in fact lethal. Other physicians 
established decades before the UC researchers conducted these experiments. A dose of 
250 rads would kill up to 50% of those who received It. A 600 rad dose would kill almost 
everyone who received it. 

The treatment methods 

An examination of the treatment methods reveals much about the true purpose of the 
experiments. Patients received treatment in a sitting position with legs raised, and head tilted 
slightly forward. This position mimics that of a soldier in a protective fetal position. The powerful 
single doses resembled the dose rate of a nuclear blast. "Whenever possible unidirectional 
radiation will t>e attempted since this type of exposure is of military interest," the researchers 
wrote in 1969. This was not the way radiation physicians used in therapeutic applications. 
Physicians give real therapy slowly and from as many different directions as possible to 
minimize side effects and maximize efficacy. 

In addition, the UC researchers denied the patients treatment for nausea and vomiting. This was 
apparently so anathema to the hospital staff used to caring for patients that the researchers had 
to create a special form to ensure that the doctors, nurses and other personnel would not perform 
their usual function of caring for sick patients. This form instructed hospital staff not to ask about 
the symptoms and signs of radiation poisoning. ' DO NOT ASK THE PATIENT WHETHER HE 
HAS THESE SYMPTOMS ." the fonm said. The form went on to instruct the staff to record the 
time, duration and severity of these symptoms. The researchers offered no treatment. 

From another DOD report we find that the researchers sought to psychologically isolate the 
patients, "There is no discussion of possible subjective reaction resulting from the treatment with 
the patient. Other physicians, nurses, technicians and ward personnel are instructed not to 
discuss post-irradiation symptoms or reaction with the patient. This 'isolation' is carried out 
carefully so as not to influence any objective reactions of the patient which might be attributable 
to radiation." Patients resided in the psychiatry unit instead of the tumor ward, "The 
environment is far more attractive and there are no other patients receiving radiation therapy 
with whom the patient can exchange experiences." What manner of cancer treatment seeks to 
psychologically isolate patients and deny them treatment for nausea and vomiting? 



118 



II. Assessing Responsibility 

In my opinion the responsibility for tliese experiments rests on many shoulders. These 
Include: the government agencies that funded them and failed to provide adequate ethical 
safeguards; the Congress which failed to provide adequate oversight; the researchers 
who violated their Hippocratic oaths and their sacred trust with their patients; the 
universities which failed to provide adequate oversight of their researchers; the Journals 
that published the work without comment, or review of the ethical issues that the 
research raised. 

The research conducted by UC researchers was clearly unethical and resulted in the deaths of 
many of the irradiated patients. Dr. Stephens revealed this information to the public in 1971. Dr. 
Thomas Gall brought this Infomnation to the attention of University personnel in 1966. 

We must address several if we are to assure ourselves that similar experiments will not occur in 
the future. 

1 . If the research was wrong and people knew it was wrong when it was done, why wasnt it 
stopped sooner? In fact, the Suskind committee suggested that the research should continue in 
a modified form. 

2. Why was there no outcry, apology or thorough investigation after the research became 
public? 

There are several answers to these questions. 

1. There was a lack of appropriate oversight by the University. 

There are several reasons for this. 

A. No one likes to admit they made mistakes or apologize. 

B. Dr. Saenger and his colleagues were well known and respected. It is hanj to criticize the 
powerful and famous. Dr. Mossman, head of the Health Physics Society, told me at the last 
Congressional hearing that he would not criticize Dr. Saenger because he was a "big man." 

C. Physicians do not like to criticize their peers especially if they work at the same institution. 

D. The University ignored the timely criticisms of is own faculty, (letters by Drs. Gaffney and 
Gall -1967) 

E. The University allowed the research to continue from 1966-1971 without the approval of its 
own human subjects review board established in March 1966. The UC research review 
board granted a protocol limited to WBR and bone man-ow transplantation provisional 
approval in May 1967. The approval granted in 1967 was provisional and requested that 
three modifications be made to the original protocol. A final revised protocol was not 
approved until August 1971. The experiments continued during this entire period. 

F. At least two of the researchers were mernbers of the University committee (Suskind report) 
that investigated the research. The UC burdened the researchers with the evaluation of their 
own work. This is a clear conflict of interest and a situation that is not likely to result in an 
objective evaluation of the research. (See below) 

G. The University chose to attack the messenger by using McCarthyite tactics against the 
critiques of the research. This has continued to date. 



119 



7. There was lack of appropriate oversight by the Medical Community 

a. The United States Senate requested that an "outside review" be carried out by the 
American College of Radiology (ACR). Dr. Robert McConnell a "long time fishing partner" of 
Dr. Saenger conducted this "review". In his report to the Senate Dr. McConnell noted that 
Dr. Saenger was a member of the American College of Radiology. IHe neglected to mention 
his personal friendship with the principle investigator or the fact that Dr. Saenger was at the 
time of the Investigation a memt)er of five different committees of the American College of 
Radiation, Including the Commission on Radiological Units, Standards, and Protection, the 
Committee on Research and Development In Nuclear Medicine, the Commission on Public 
Health, the Subcommittee on Nuclear Medicine Technology, and the Committee on Efficacy. 
Prior to the investigation Saenger also served as a member of the Subcommittee on 
Radiological Aspects of Disaster Planning. These relationships constituted a conflict of 
interest and a situation that is not likely to result in an objective evaluation of the research. 

b. Two UC researchers were members of the UC committee that reviewed the research for 
the University. This is an obvious conflict of interest. 

c. The Ohio board of medical licensure has to date not investigated any of the physicians 
involved in this series of experiments. 

d. The Cincinnati Medical Society has not investigated this series of experiments. 

3. There was lack of appropriate oversight by the Congress. 
Senator Taft vigorously obstructed a potential Senate investigation. 

4. There was lack of appropriate oversight by the Department of Defense. 

Who reviewed this wori< v^ile it was conducted? Is there a current investigation of this 
research? 

5. Were there violations of Medicare or Medicaid rules? 

If it is true that the DOD only funded researcher salaries, overtiead and travel money then public 
funds paid for these experiments. 

6. The press failed in its oversight role. 

The press, the last link in the chain that must protect our citizens from its govemment failed to 
cover the story. The press permitted the uncontroverted comments of the researchers and 
universities to stand alone as reports on these experiments. 

7. The previous investigations were inadequate and filled with conflict of interest 
problems. 

It is important to consider the University's evaluation of these experiments (Suskind report). 
When these experiments again reached the public consciousness this year, the University 
claimed the review agencies had found the experiments to be ethical and appropriate. It is my 
opinion that the reviews were Inadequate and wrong. Nonetheless the University, the 
researchers, and the DOD have used the reviews to protect themselves from scrutiny. The 
reviews were part of an organized effort to mislead the public about the research. A careful 



120 



examination of the Suslcind report reveals the inadequacies of the University's analysis of the 
radiation experiments and the unethical nature of the experiments themselves. 

a. What were the objectives of the study? 

The only protocol that preceded the experiments indicates that the purpose was to provide, 
"information [that] is necessary to provide knowledge of combat effectiveness of troops and to 
develop additional methods of diagnosis, prognosis, prophylaxis and treatment of these injuries.* 
(pg. 1 DOD report 1963) 

After the research was publicly criticized, the researchers claimed the DOD protocol was an add- 
on to a cancer treatment program. A cancer treatment protocol was produced in 1966 and 
approved on August 9, 1971. Pertiaps because UC researchers never implemented any protocol 
while the study was conducted, friendly reviewers have had differing conclusions about the 
purpose of the experiments. 

The ACR stated that the experiment was a Phase I study of the toxicity of whole body radiation 
in humans. American College of Radiology: The committee viewed the project as it was 
designed - as a clinical investigation of a modality for the care of cancer patients with extensive 
and incurable disease. Phase one investigations follow basic animal woric and always precede 
randomized clinical trials which may or may not be justified on the basis of the first human 
applications.' (pg. 3) 

Suskind found the experiment to be a Phase II cancer study of the efficacy of treatment. 
Suskind's report states that the hazards of whole body radiation were well established before the 
UC studies were started, the hazard [bone marrow suppression] is well documented in the 
available literature and the dose relationship to side effects well understood.' (pg. 9) Suskind 
then states that the study was some type of Phase II study of the efficacy of bone marrow 
transplant and radiation. However, of the 87 patient's treated only 13 received a bone marrow 
transplant. In addition, Suskind notes, "The committee, however, was unable to find any written 
protocol in which the purpose of the study was to determine palliative effects of whole body 
radiation until. ..1967.'(pg. 14) He latter notes, 'No plan for a systematic study of palliative 
effects was made.' (pg. 64) 

Only the researchers' own words fully explain the experiments. They explained that the purpose 
was military. Only this purpose explains the experimental design, that included psychological 
isolation, organized denial of treatment for nausea and vomiting, and no plan for analysis of 
cancer palliation or treatment efficacy. Since treatment was not the intent of the study there was 
no need to organize the study so that treatment outcomes could be evaluated. 

b. Was there a need to test whole body radiation for cancer treatment? 

Suskind reviewed the prior studies of WBR to try to see if physicians had conducted adequate 
Phase II trials prior to the UC experiments. They report universal failure. 'Medinger and Craver 
(1 942) - Results were described as discouraging in this group of patients 'except for transient 
relief of pain in a few cases'." Jacobs and Marasco (1965) - 1 1 of 16 "died within one month of 
treatment; the remaining 5 having survivals of 1-1/2, 2, 3, 4. and 9 months. The statement 
suggesting the need for further evaluation of this form of treatment refers most probably to the 
radiosensitive, widespread neoplasms rather than the results in the 16 patients with 
radioresistant cancers." (pg. 10-11) In addition, Suskind could not find anyone else performing 
similar experiments, "Although whole body radiation is widely used for many forms of 
radiosensitive tumors, no infonnation is available to the committee which indicates that this form 
of treatment is used elsewhere in radioresistant, disseminated or localized cancers as used at 
the University of Cincinnati." (pg. 12) 



10 



121 



Suskind notes that in 1966, This proposal received a critical internal review and was submitted 
to the NIH in an application for a research grant. The application was not approved and the 
reasons for this decision were not disclosed.' (pg. 42) This was not true. In 1969, Evelyn Hess 
MD, the chairwoman of the facurty committee on research wrote that NIH had rejected two 
research grants because, the acceptability of our general consent fonm for human volunteers 
participating in research was questioned.' 

Suskind concluded that. The Phase II criteria for whole body radiation were not adequately 
satisfied at the time the original protocol was designed in 1960 and evidence for its effectiveness 
was incomplete. The results which were available for interpretation were not encouraging. 
Hence, the need for mounting a Phase II study at that time was indicated." (pg. 11) 

If, after reviewing the dismal results of previous studies examining WBR use for radioresistant 
tumors and faculty criticisms of the WBR experiments at UC, Suskind really thought another 
study was necessary, there is something fundamentally wrong with the way UC researchers 
evaluate medical treatment and research needs. This is pertiaps a more important area of 
investigation than the original studies themselves. 

It may indicate that there is still a problem in this area at UC today. If the University authorities 
cannot recognize that the WBR experiments were wrong and apologize to the community, how 
can the community trust them to evaluate current experimental programs? 

c. Quality of care 

Suskind: The thoroughness of the psychological support is apparent from the report of the 
psychological staff." (pg. 28) 

DOD report: There is no discussion of possible subjective reaction resulting from the treatment 
with the patient. Other physicians, nurses, technicians and ward personnel are instructed not to 
discuss post-irradiation symptoms or reaction with the patient. This 'isolation' is carried out 
carefully so as not to influence any objective reactions of the patient which might be attributable 
to radiation.' (pg. 4) 

If denial of treatment for nausea and vomiting and psychological isolation is good quality of care 
perhaps there is a cunrent problem at UC in this area as well. 

d. Ethics 

Suskind: "Patients and families were not infomied about the possibility of transient nausea and 
vomiting since such symptoms may be induced by suggestion. Typically, such side effects can 
occur a few days after treatment.' (pg. 50) 

Suskind: "Were there patients, whose IQ was subsequently determined to be 75 or below, who 
signed the consent form themselves? 

Yes there were ten patients. There was no reason to believe that they did not understand the 
conditions of the project. The Committee also questions the significance of the scores of 
intelligence tests in this group of patients who were dying of far advanced cancer.' (pg. 51) It 
was precisely these IQ scores that formed part of the basis for the DOD cognitive effects 
research. 

Suskind: "Informed consent should be obtained as it is now. Revisions of the consent forms 
should be considered in relation to the use of the phrase 'sound mind and body". The procedure 
for withdrawal from the project should be improved." (pg. 56) 



11 



122 



If it is Susliind's (and the University's) opinion that side patients with IQ's less than 75 who are 
not told about side effects like nausea, vomiting and a 25% death rate within weeks of treatment 
can provide informed consent there is a serious problem at the University. 

e. Research quality 

Suskind noted. "It is uncertain whether this study and similar studies reported in the medical 
literature are truly comparable in all major factors that influence survival, such as selection of 
patients and ancillary medical management. Therefore, the significance of comparisons of 
survival rates is doubtful, unless marited differences are found."(pg. 59) 

"Since the manner in which the data on palliative effects was developed was inadequate, no 
conclusions can be drawn from them.' (pg. 66) 

Despite these comments Suskind concluded, "Since the Committee cannot at this time rule out a 
positive effect of whole body radiation, a well-designed study to compare whole body radiation 
with other forms of therapy is necessary if the investigator wished to continue." (pg. 66) 

Is this the current type of analysis UC uses to evaluate research and researchers? 

III. Why did this happen? 

That's a list of who but the answer to why this occurred is a more subtle and important issue. Our 
population views the United States as a unique country, and it is. It is uniquely democratic; these 
hearings are an example of that. It is my belief that we in the United States have a certain belief 
in the infallibility of our own history and our own behavior. We tend to believe that our actions 
could only have good intentions. I am afraid this is not so. We have at times done the wrong 
thing for the wrong reasons just as many other countries have done. The history of medical 
science, replete with the use of certain marginalized groups in our society for harmful 
experimentation, offers some examples of repugnant actions performed in this country. Perhaps 
these experiments will serve as a turning point and provide us with a fresh look at ourselves. A 
look that recognizes that the United States is the greatest country on earth but also recognizes 
that it is not an infallible country. That not everything we have done has been with good 
intentions or with good results, and therefore we. like other countries, must remain vigilant of our 
govemment, and our citizens and our companies. We must continue to maintain and buttress 
our system of checks and balances to assure us that these types of experiments will never go on 
again. 



12 



123 



IV. What should be done? 

A. Short term 

1 . The University should apologize. 

2. The victims or their families should be compensated. 

3. State Medical boards should investigate. 

4. Criminal investigations should occur. 

5. A single Congressional investigation should occur. 

6. The DOD should investigate their role and oversight procedures 

7. Medicare and Medicaid agencies should investigate the possible use of patient care funds for 
research. 

8. The Association of Occupational and Environmental Clinics should provide an independent 
non-governmental evaluation of all of the DOD, NASA and DOE research. 

B. Long term 

1 . Medical review boards must be composed of >50% independent and unrelated researchers 
and lay people. 

2. Medical joumals should have ethical reviewers. 

3. NIH must inform appropriate authorities when they find that a research project violates 
ethical standards. Their silence must stop. 



13 



124 



Some people have asked why I am here. To paraphrase Thoreau. the question should not be 
why am I here, but why aren't other responsible parties here? It is every physician's duty to 
speak out when medicine goes wrong. 

To quote from Pastor Niemdier about the Holocaust: 

•In Germany the Nazis came for the communists, and I did not speak up since I was not 

communist. 

Then they came for the Jews, and I did not speak up since I was not a Jew. 

Then they came for the trade unionists, and I did not speak up since I was not a trade unionist. 

Then they came for the Catholics, and 1 was a Protestant so I did not speak up. 

Then they came for me. and by that time no one was left to speak up. 

Thanks 

My wife Helene, my students, my staff, my friends at NIOSH. Mitch Singal. and Bill Halperin, 
and my friends, particularly Mike Donahue. 



14 



125 
Contemporaneous comments of colleagues 



"It is not certain from the (consent form) nan^tive winether the patient 
is advised that no specific benefit will derive to him and that there are, 
indeed rislcs involved in the procedure proposed." - Edward Gall MD, 
1966 

"I Ijelieve a twenty-five percent mortality is too high." All patients 
should be informed not only that a "risk exists" but of, "a 1 in 4 chance 
of death within a few weeks' of treatment - George Shields MD, 1 967 



statement to Congress April 11. 1994 l)y DavW S. Egilman MD. MPH. 

•i-^ k. ... 



126 

Contemporaneous comments of 

colleagues 

"The applicants have apparently already administered 150-200 rads 
to some 18 patients with a variety of malignancies and to their 
satisfaction have not found a beneficial effect. In fact, as I understand 
it they found considerable morbidity associated with this high dose of 
radiation. Why is it now iogical to expand this study? 

Even if this study is expanded, its current design wiii not yield 
meaningful data. ... It will be difficult if not impossible to observe a 
beneficial effect in such a small sample containing a variety of 
diseases all of which share only CANCER in common. 

This gross deficiency in design will almost certainly prevent making 
meaningful observations. When this deficiency in experimental 
method is placed next to their previously observed poor result and 
high morbidity with this type of treatment in a 'variety of neoplasms' I 
think it clear that the study should not be done. - Thomas Gaffney 
IVID-1967 

statement to Congress April 1 1 , 1 994 t)y David S. Egllman MO. MPH. i 



127 

Contemporaneous comments of 

colleagues 

...."the acceptability of our general consent forni for human volunteers 
participating in research was questioned" - Evelyn Hess MD - 1969 
commenting on the reason for rejection of two grant applications by 
the National Institutes of Health. 



statement to Congress April 11, 1994 t>y David S. Egilman MD, MPH. 



128 
Overview 



1 . First I will the descritw ttie wtiole body radiation (WBR) experiments that were conducted at 
the UC. These were designed to provide information to the military. They were not in any 
way cancer treatment or palliation. Some of those studies resulted in the deaths of their 
sutijects. 

2. Secondly, I will address the question of whether the experiments were conducted according 
to the ethical standards of their time. The answer to this question is a firm no. 

3. Third, I think we should consider why these experiments were allowed to occur and continue 
over a considerat)le period of time. Why did it take until 1994 for these activities to reach 
the national consciousness? 

4. Fourth, we must do our best to right past wrongs. We must accurately assess responsibility 
for these studies if we are to address my final concern: how can we prevent this from 
happening again? I wouM argue that this necessitates taking several long and short-term 
steps, including the following: 

A. We must document and assess what happened. 

B. Compensation shouM be provMed to those who were harmed. 

C. Appropriate actions shoukl be taken against researchers who acted improperly. 

D. We must establish permanent mechanisms to assure that this type of experiments will not 
occur again. 



Statement to Congress April 1 1 , 1994 by DavM S. Egilman MD, MPH. 



b. <> \ k < • 



129 
The University of Cincinnati Experiments 1960-1972 

a. Ethics and Informed Consent 

On November 28 1 950 Dr. Joseph Hamilton wrote a letter to Shields Warren 
MD., Director Division of Biology and Medicine, The Atomic Energy Commission 
(AEC). 

(AEC) researchers wanted to determine the dose that might limit a soldier's 
"capacity to execute intricate tasks for which physical well being is essential." 
Hamilton discussed the difficulties of performing such a research study, and 
suggested that "For both politic and scientific reasons, ... it would be 
advantageous to secure vt^at data can be obtained by using large monkeys 
such as chimpanzees which are somewhat more responsive than lower 
mammals." 

If the research was to be done on humans. Dr. Hamilton predicted that "those 
concerned in the (AEC) would be subject to considerable criticism, as 
admittedly this would have a little of the Buchenwald touch ... The volunteers 
should be on a freer basis than inmates of a prison. At this point, I haven't any 
very constructive ideas as to vt^ere one would turn for such volunteers should 
this plan be put into execution." 

statement to Congress April 11,1 994 by David S. Egilman MD. MPH. S 



130 

The University of Cincinnati Experiments 1960-1972 

a. Ethics and Informed Consent 
2. Selection of subjects 

a. Uneducated - average 4th grade 

b. Low Intelligence - average IQ 84 (many mentally 
retarded 

c. Brain dysfunction (did not 
know how to follow instructions) 

d Patients with tumors that were resistant to 

radiation therapy. 

e. "They must be in relatively good nutritional 

status and with a stable hemogram. ' 
f 54 of 88 patients African-American 

These researchers, like others involved in similar experiments 
funded by the DOE and NASA, selected the most vulnerable of 
our citizens as subjects, the poor, the mentally and emotionally 
impaired, and African-Americans. 



statement to Congress April 11. 1994 by David S. Egilman MD, MPH. 



131 
The University of Cincinnati Experiments 1960-1972 

a. Ethics and Informed Consent 

1) Patient population was incapable of giving 
informed consent. 



2) Patient population not informed of the 
experimental risks. 



statement to Congress April 11, 1994 by David S. Egilman MD, MPH. 



132 

The University of Cincinnati Experiments 1960-1972 

a. Ethics and Informed Consent 

3. Researchers were aware of Informed consent requirements- 

a. Researchers claimed - paUents informed of the 

risks and complications. 

b. Researchers reported - omy e of first 33 

patients received any information on the nature of the experiment 

c. Researchers claimed - they receh^ed informed 

consent in the paper they published. 

d. Researchers reported - they did not ten the 

patients of the risics. 

If their published papers correctly report their failure to advise patients 
about the possible experimental risks, their stated conclusion that they 
received informed consent is surely wrong. 

There is no better evidence that they violated their own 
and our own ethical and moral standards. 



statement to Congress April 1 1 . 1994 by David S. Egilman MD. MPH. 



133 

The University of Cincinnati Experiments 1960-1972 

a. Ethics and Informed Consent 

3. Researchers were aware of Informed consent requirements 

a. Researchers were aware of the Helsinki code 
The Declaration states: 

(4) Every clinical research project should be preceded by 
careful assessment of inherent risks in comparison to foreseeable 
benefits to the subjects or to others. 

II (2) The nature, the purpose and the risk of clinical research 
must be explained to the subject by the doctor. 

II (3) ...the responsibility for clinical research always remains 
with the research worker; it never falls on the subject, even after 
consent is obtained. 



statement to Congress April 11, 1994 by David S. Egilman MD, MPH. 



134 
The University of Cincinnati Experiments 1960-1972 

a. Ethics and Informed Consent 

4. Researchers were aware research was "questionable ethically" 
a. Similar experiments were rejected in 1966. 

*The suggestion is made that we should treat carcinoma of the breast, 
gastrointestinal tract, and urogenital tract by total body irradiation. These 
groups of patients have been carefully considered for such therapy, and we are 
very hesitant to treat them because we beiieve there is so little chance of 
benefit to make it questionable ethically to treat them. Lesions that require 
moderate or high doses of local therapy for benefit, or that are actually 
resistant (gastrointestinal tract) are not helped enough by total body 
irradiation to justify the bone marrow depression that is induced." 
(emphasis added) 

The argument that these experiments were appropriate from the ethical 
standards of the 1960's lack both scientific and historic accuracy. 



statement to Congress April 1 1 , 1 994 by David S. Egilman MD, MPH. 10 



135 

The University of Cincinnati Experiments 1960-1972 

b. Cancer therapy was not the purpose of this research. 

1) Result of previous research - Dismal 

a) "little or no benefit follows its use in the treatment of 
ge neralized carcinoma or sarcoma " (emphasis added) (Medinger and Graver 
1942). 

'The results in these generalized carcinoma cases were discouraging. The 
reason for this is quickly apparent. Carcinomas are much more radioresistant 
than lymphomatoid tumors, and by total body irradiation the dose cannot be 
nearly large enough to alter these tumors appreciably." 

b) In no patient was there evidence that total-body irradiation 
affected the disease ." [with radioresistant tumors] (emphasis added) 
(Jacobs and Marasso 1965). 

A dose which will kill the tumor will also kill the patient 



statement to Congress April 1 1 , 1994 toy David S. Egilman MD, MPH. 11 



136 

The University of Cincinnati Experiments 1960-1972 

b. Cancer therapy was not the puroose of this research. 

2. The Researchers themselves described the purposes of the . 
experiments in their reports to the Department of defense. 

The purpose was, " to provide Icnowledge of combat 
effectiveness of troops and to develop additional methods of 
diagnosis, prognosis, prophylaxis and treatment of these 
inluries." 



St^ement to Congress April 11. 1994 by David S.EgilmanMD.MPH. 12 



137 

The University of Cincinnati Experiments 1960-1972 
b. Cancer therapy was not the purpose of this research. 



Issue 


Real Medicine 


Military Rcscjirch 

Di:Mt:D 

PAIIEMS 

PSYCHOLOGICALLY 

ISOLATED 

FAST 

UNIDIRECTIONAL 


TREATMENT FOR NAUSEA 
AND VOMITING 


PROVIDED 


PSYCHOLOGICAL AND 
PEER COUNSELING 


PROVIDED 


DOSE RATE 


SLOW 


DOSE DIRECI ION 


MULTI- 
DIRECIIONAL 



What manner of cancer treatment psychologically 
isolates patients and deny them treatment for nausea 
and vomiting? 



statement to Congress April 1 1 . 1 994 by David S. Egilman MD. MPH. 



13 



138 

The University of Cincinnati Experiments 1960-1972 

C. Assessing Responsibility 

1. Government agencies that funded tliem and failed to provide 
adequate ethical safeguards - DOD, 7Medicare and Medicaid. 

2. Congress failed to provide adequate oversight 

3. Researchers violated their trust with their patients. 

4. Universities failed to provide adequate oversight 

5. Journals that published the woric without comment failed to 
provide adequate oversight . 

6. NIH refused to fund the work on ethical grounds l(ept silent 



statement to Congress April 1 1 , 1 994 t>y David S. Egilman MD. MPH. 14 



139 

The University of Cincinnati Experiments 1960-1972 

D. Explaining the continuance of the experiments in the face 
of ethical questions 

1. There was a laclc of appropriate oversight by the University. 

2. There was lacl( of appropriate oversight by the fVledical 
Community 

a) ACR The fishing buddy reviewer 

b) The Ohio board of medical licensure 

c) The Cincinnati Medical Society 



statement to Congress April 1 1 , 1994 by David S. Egllman MD, MPH. 15 



140 

The University of Cincinnati Experiments 1960-1972 

D. Explaining the continuance of the experiments in the face 
of ethical questions 

S. TiMrawn lack or appropriate ovMsight by thtCongrMS 

Senator Taft vigorousiy obstructed a potential senate investigation. 

4. Then was lack of appropriate oversight by the DepartnMnt of Defense. 

WlK> reviewed tttis work wliile it was being conducted? Is ttteiB a current investigatkm of 
this research? 

5. Were there violations of medicare or medicaid rules? 

If it is tnie that the DOO only funded researcher salaries, overhead and travel nMney 
then public funds paM for these experiments. 
i. The press felled in ite oversight role. 

Permitted the uncontroverted conunents of the researchers and universities to stand 
alone as reports on these experiments. 



Statement to Congress April 11. 1094 by DavU S. Egilman MO. IMPH. 



141 

The University of Cincinnati Experiments 1960-1972 

D. Explaining the continuance of the experiments in the face 
of ethical Questions 

7. Previous investigations inadequate, filled with conflict of interest, incomplete 

researcli and IHzarre analysis. 
The Reviewers' views: 

a) What were the objectives of the study? 

i) The ACR - phase I study of the toxicity of whole body radiation in humans. 

iO Suskind -phase II cancer study of the efficacy of bone mam>w transplant and 

radiation. 

ill) The UC researcltere stated purpose was ignored. 

b) Was tttere a need to test whole body radiation for cancer treatment? 

I) Suskind reviewed the prior dismal studies of WBR 

iO Suskind found that no one else anywhere In the wortd is doing this. 

110 Suskind found that in 1966 NIH rejected the proposed research 

Suskind concluded, "the need for mounting a Phase II study at ttiat time was indicated.* 

If the Unhrereity authorities cannot recognize that ttte WBR experiments were wrong and 
apologize to ttie community, how can tlM community trust ttiem to evaluate current 
experimental programs? 



Statement to Congress April 11 . 1994 by DavM S. Egilman MO. MPH. 17 



142 

The University of Cincinnati Experiments 1960-1972 

D. Explaining the continuance of the experiments in the face 
of ethical questions 

7. The previous investigations were inadequate and filled with conflict of interest 

problems, incomplete researeh and bizarre analysis. 

c) Quality of care 

Suskind: The thoroughness of the psychological support is apparent from the report of the 
psychological staff.' (pg. 28) 

DOD report: The patients were psychologically isolated and denied treatment for nausea and 
vomiting. 

If denial of treatment for nausea and vomiting and psychological isolation is good quality 
of care perhaps there is a current problem at UC. 



Statement to Congress April 11. 1094 by David S.EgilmanMD.MPH. It 



143 

The University of Cincinnati Experiments 1960-1972 

D. Explaining the continuance of the experiments in the face 
of ethical Questions 

7. The previous investigations were inadequate and filled with conflict of interest 

problenis, incomplete research and bizarre analysis. 
d)Ethics 

Susidnd: "Patients and families were not infonned about nausea and vomiting.... 
Typically, such side effects can occur a few days after treatment.' (pg. 50) 

Susldnd: Patients, with IQ's 75 or below (mentally retarded] can 'understand the conditions of 
ttie project' and provide informed consent. 

if it is Susidnd's (and the Univereity's) opinion that sicic patients with IQ's less than 76 
who are not told about side effects like nausea, vomiting and a 25% death rate within 
weeics of treatment can provide informed consent tttere is a serious problem at the 
Unhrersity. 



Statement to Congress April 1 1 , 1994 by David S. Egilman MD, MPH. 



144 

The University of Cincinnati Experiments 1960-1972 

D. Explaining the continuance of the experiments in the face 
of ethical Questions 

7. The previous investigations were inadequate and filled witii conflict of interest 
problems, incomplete research and bizarre analysis. 

e) Research quality 

Suskind noted, ..." the significance of comparisons of survival 
rates is doubtful, unless mariced differences are found."(pg. 59) 

"Since the manner in which the data on palliative effects was 
developed was inadequate, no conclusions can be drawn from 
them." (pg. 66) 

Despite these comments Suslcind concluded a modified 
study could continue, (pg. 66) 



Is this the current type of analysis UC uses to evaluate 
research and researchers? 



statement to Congress April 1 1 , 1 994 by David S. Egilman MD, MPH. 20 



145 

V. What should be done? 

A. Short tenii 

1 . The University should apologize. 

2. The victims or their families should be compensated. 

3. State Medical boards should investigate. 

4. Criminal investigations should occur. 

5. A single Congressional investigation should occur. 

6. The DOD should investigate their role and oversight procedures. 

7. Medicare and Medicaid and the city should investigate the diversion of patient care monies 
to research. 

8. There should be an investigation by the Association of Occupational and Environmental 
dinics. 

B. Long term 

1. Medical review boards must be composed of >50% independent and unrelated researchers 
and lay people. 

2. Medical journals should have ethical reviewers. 

3. NIH should atMndon its a code of silence. 
Thanks 

My wife Helene, my students, my staff, my supervisors at NIOSH, Mitch Singal, and Bill 
Halperin, and my friends particulariy Mike Donahue. 



Statement to Congress April 11. 1004 by OavMS.EgilnuMi MO, MPH. 21 



146 
ERRATA 

The University of Cincinnati Experiments 1960-1972 

On page 4, paragraph 3, line 6 the sentence should read: "In 
reviewing a suggestion that patients with carcinoma of the breast, 
gastrointestinal tract, and urogenital tract should be treated by 
total body irradiation, the Oak Ridge researchers made the 
following statement..." 



statement to Congress April 11, 1994 tiy David S. Egilman MD, MPH. 



147 

Mr. Bryant. Dr. Stephens. 

STATEMENT OF MARTHA STEPHENS, Ph.D., PROFESSOR OF 
ENGLISH, UNIVERSITY OF CINCINNATI 

Dr. Stephens. I have been somewhat disappointed that we 
couldn't hear from more family members. I would like to look at 
some of the medical charts. 

The family of the people who spoke to us today suffered. I think 
everybody that was in these experiments suffered. They were made 
sick for several days — intensely, usually. Many had to go into the 
hospital for this treatment. They were taken out of their homes, 
called up, told to come to the hospital for this treatment. 

No matter how long they lived after the radiation, they suffered. 
The doctors tell us in fact that it can take up to 100 days to recover 
from whole body or partial body radiation. For those who didn't die 
directly of the radiation, nevertheless they all suffered, were made 
ill, possibly were sicker than they would have been for up to 100 
days, the ones that lived that long. 

Now, we did not hear this morning from any of the so-called 
short survivors, and we must remember that there were at least 
eight people who died directly of radiation. We can document this 
from the doctors' reports. They give us the blood scores for those 
patients. These patients died within 40 days. We know that they 
suffered from bone marrow failure. And when that happens, you 
are wide open to infection. Infection swoops down and takes you 
away because you have no white and red blood cells to fight it with. 

Thus, I wish we could have heard from a lot more families. Let's 
remember this: 26 people died within 60 days. Their lives were al- 
most certainly hastened by radiation. 

As the years went on, the doctors stopped telling us what the 
blood scores were, because they were no longer studying what was 
happening to the blood scores. They had already found out that 
with 200 rads of radiation, you have a good chance of dying of it. 
They knew what would happen, and they kept on doing it. 

So we don't know, for all of those 26 people — that is, until we 
study the medical records which we have only recently gotten and 
which Dr. Egilman now is studying and others will be studying — 
we don't know exactly how all of them died. I am sure we will find 
that many more than eight also suffered severe bone marrow de- 
pression. 

The question has been raised, were these patients terminal? My 
view is, many were not what we would in common parlance today 
call terminal. Early on in the experiments, a woman was irradiated 
who had had cancer of the tongue. She was given a high dose of 
radiation that she might have died from. She was submitted to 
that lethal risk, but she recovered. 

You usually either die or begin to get better within about 40 days 
of having total body radiation. 

She survived. She got very sick, but she survived. She lived after 
that over 5 years. In fact, we don't know the date of her death. I 
don't think she could be considered terminal at the time she re- 
ceived this high, possibly lethal dose of radiation. 

I have been particularly interested in one patient. No. 090, be- 
cause of those 26 patients who died between 6 and 59 days after 



148 

they were irradiated, she is the shortest survivor of all. She lived 
only 6 days after her radiation. She was an 80-year-old African- 
American woman who lived in Hillsboro, OH. 

I did not know until last Friday when I went to a meeting of the 
families in attorney Bob Newman's office that her family have been 
identified. I had wondered all of these years who they were. I didn't 
know her name. Her name is Margaret Bacon. Here is what hap- 
pened to her. First I should say that we have heard a good bit 
about bone marrow transplantation and whether this could have 
helped protect the people who were receiving the higher doses in 
the later years of the project. It wasn't even tried until mid-way 
through the project, and at that time, even, it was experimental. 
The doctors were not sure they could make it work. 

So Margaret Bacon had an operation to have her bone marrow 
removed so that it could then be replaced after her irradiation, to 
give her a chance of her bone marrow recovering. On the operating 
table — and this was a severe, serious operation, to have your bone 
marrow removed, it was another ordeal that people had to go 
through, it took up to 2 hours with general anesthesia — on the op- 
erating table or shortly thereafter she suffered a stroke. 

She still was irradiated that very day, at 2. They probably did 
not know that she had suffered a cerebral accident. We read in her 
patient history, she was shammed, that is, given fake radiation to 
"see whether that would have any psychological effects, on June 2, 
1969. On June 4, bone marrow was aspirated from the posterior 
and anterior sternum with ease. 

At approximately 2 in the afternoon, the patient received 150 rads midline tissue 
dose total body irradiation. 

She experienced only mild nausea and vomiting. Following irradiation, the bone 
marrow was infused. The patient tolerated the procedure well. No fever, chills, were 
noted. 

On June 9, 1969, the patient was noted to have left sided facial weakness. This 
is just a few days later. Suggestive of a cerebral vascular accident. 

On June 10, the next day, six days post TBR, she expired. 

In that same report that the doctors submitted, which contains 

this history, we read as follows. 

The second death (patient 090) was anesthesia related. Four days, they say here, 
after the procedure, that is, the bone marrow aspiration. 

I could read — maybe I will have a chance later on, to look at 
these statements from her family, her nephew, her great niece and 
her great nephew, who appeared at our meeting on Friday, and 
they have submitted to you three statements. 

They, like the others, do not know anything of an experiment 
being carried out on their aunt. 

If I may return to the question of informed consent, there is no 
evidence of any kind of consent for the first 5 years, written, oral, 
otherwise. There is no evidence that has ever been put forward. 
When consent forms were introduced — and after all we do have 
these, I saw them years ago, we do have the consent forms — none 
of them ever stated the real risk to the patients, that is, none said 
to the patient, "You may die of this treatment, do you really wish 
to have it?" None ever said that. 

I have two recommendations I would like to make, if there is 
time. 



149 

Mr. Bryant. You might summarize them so we can begin to ask 
questions. 
Dr. Stephens. Maybe I will save those. Can I save those'' 
Mr. Bryant. Very well. 
Thank you very much. 
[The statement of Dr. Stephens follows:] 



150 
Slntement for House Judiciary Committee — Martha Stephens 

Q. How did you first find out about the radiation project at U. C? 

A. In the fall of 1971 I was starting my fifth gear in the University of 
Cincinnati English Department. I was thirty-four, an Assistant 
Professor. 

When I first began to look into these experiments, I had no idea 
anyone had died of the radiation. In the corridor of McHicken Hall one 
day. a friend in the department, Dave Logan (now the director of 
Prospect House, an alcohol treatment center in Cincinnati), showed me a 
brief report from the VilJage ^/7/r^ about experiments being done at U. C. 
for the Defense Department, using poor cancer patients. The reporter 
was questioning whether or not the patients knew they were in an 
experiment; he said some were being irradiated over their whole bodies 
and were suffering nausea and vomiting for several days afterward. 

This was all we knew when a group of us in the Junior Faculty 
Association decided we should look into the matter. We were living in 
the tail-end of the sixties, after all, not long after the bombing of 
Cambodia and so on, and we should remember that many Americans had 
developed a profound distrust of everything that issued from the Defense 
Department. 

I had a research leave coming up in the winter, with time to study 
this issue, and I went over to see Edward Gall, who was then director of 
the nodical Center. I remember visiting him several times and trying 
out various arguments on him to try to get information; he was 
courteous, but for quite a while nothing was forthcoming from him. I 
remember his saying that the files on the project were long and 
complicated and would not mean much to people who were not doctors. 
He said, 'I'm sure you wouldn't want them all.' I said, 'We do though. We 
would like to see them all. if everything is all right, as you say. Dr. 
Gall, and we have no reason to doubt your word, then perhaps it would be 
useful to have a campus organization clear up the matter." One day I 
went back over to his office and there was a large pile of documents on 
his desk. These papers were copies of the typescript reports the doctors 
were sending to the DOD, and I would later find that they told a tragic 
and terrible tale. Even now, I do not know why Gall surrendered these 
papers to me, and I later realized I was quite possibly the first person 
outside the nodical School and the Defense Department to see them. 



151 



2 
This set of documents that hos now been copied and re-copied in 
Cincinnati ond elsewhere. 

I drove bock over to McHicken Hall that day, and I sat out on the 
campus drive, up on our hill with its beautiful lawn stretching down to 
Clifton Avenue, and pulled these papers out on my lap to see what I had. 
I saw that individual patient histories were attached to the backs of 
each of the nine reports, and I began reading these histories. I read for 
about an hour, and when I got out of the car, it was as if I could hardly 
recognize what was around me. Everything I saw looked different to me. 
I was used to reading in plays and novels about tragic deaths, full 
of pity and sorrow, but I was not used to /A/>pity, /A/^ sorrow. I felt 
that these experiments had to be stopped, and of course in due time they 
were stopped. 

Over that Christmas holiday, I spread these papers out iate at night 
over my dining room table, after our children were put to bed. and f 
wrote a summary of what had happened to the eighty-seven individuals 
that had been irradiated. I wrote about how they died. 

I presented my findings to a meeting of the Junior Faculty 
Association on January 14, and the group decided to have a press 
conference, and this we did on Januarij 26 of 1972. I feel now, as I look 
into the whole matter again, that our report was actually a conservative 
one. My friends in the JFA had yone over with me every sentence of it. 
We knew it had to be clear and it had to be riyht. I introduced a number 
of qualifying phrases, everywhere we had the least idea that an 
assertion could be challenged. Today I would not be as hesitant; but at 
that time it was as if I could hardly believe myself what I was putting 
down on paper. Still, this report told all the basic truths of the case; it 
told the truth, and it examined every possible argument the doctors 
could use to justify what they had done. 

In some ways it is even more astonishing to me today to reflect on 
what transpired and to image up the whole scene from the point of view 
of the patients that were used. Even now, after se much discussion of 
these fellow citizens of ours, we don't know all their names or where 
they lived, what they did for a living, what they personally went 
through, the ways in which their loved ones suffered — as they 
themselves waited helplessly for word of this or that from doctors and 
nurses that usually could not be found, or stood at bedsides in crowded 
words, often ^///^ wards, as various hospital users of those years have 
testified. 

These families I'm speaking of have been i* _J::-£_..:: - -• - 
' the invisible people inhabiting all our debates and 
discussions about this project. I'm thinking, for instance, of a man with 



152 



^cancer who, after his irradiation, never came bacic to the hospital, 
bore his painful disease without help, as far as we know, not willing to 
be treated again after such an experience. I think of an eighty-year-old 
African American woman, 'M. B.,* who had lung cancer and suffered a 
stroke on the operating table in 1969, having her bone marrow aspirated 
in preparation for her irradiation. She died six days afterwards — 'an 
anesthesia-related death,' as the doctors themselves describe it. Did 
she volunteer to be in an experiment that might end her life? 

Q. How many patients died? 

We know that at least B patients died of bone marrow failure as a 
direct result of radiation; for these patients the doctors provide the 
blood scores that allow us to document these cases of classic radiation 
injury. Then there were cases like that of M. B. mentioned above. Some 
of the histories, however, tell more than the others; in the later period, 
blood scores are no longer being studied and we are not generally told 
how much bone marrow depression existed at time of death. But there 
are altogether 26 individuals who died within 60 days of being 
irradiated and whose deaths were almost certainly hastened by 
radiation. For some of these shori survivors we need to see their full 
hospital charis and follow-up in the clinics and hospitals to know 
exactly how they died. 

Q. Were these cancer patients terminal? Were they people expected to 
live only a few months, as the medical school has said? 

The patients who survived the radiation often lived several years. 
One woman with cancer of the tongue was irradiated in 1961 and lived at 
least five years after the radiation. We in fact do not know when she 
died. 

A later group of subjects were chosen specifically because they 
were in relatively good shape, were not elderly, and could be 
interviewed in their homes or workplaces about coming in for this 
'treatment.* They were working, eating normally, with good blood 
counts. Definitely not bed-ridden, extremely feeble, or about to die. 

Q. Who were the doctors? 

It was not a question of one or two or three individuals periorming 
a deadly rite that very few other doctors knew about. A project tiiSi 

goes on for eleven yeors ond involves the screening and CodSi deration of 

at least 1 1 1 patients had to be known to a great many people. There 
were thirteen doctors Wi this team over the years, co-authoring the 
reports and publications, and many more who assisted in various ways 



153 



4 
and were sometimes closely involved, in the complex testing of 
irrodioted subjects for mental functioning, for instance. Then we have 
the doctors who were staffing the Tumor Clinic at the hospital and 
willing to hand over patients to the chief investigator and his 
associates, as well as staff at several other hospitals; at least three 
subjects were 'recruited' from Draice, to use the doctors' term, and 
three youngsters with Ewing's sarcoma were brought over as 
'volunteers' from Children's. 

Though Dr. Bernard Aran has been put forward by the Medical School 
as if he were an uninvolved or neutral spokesman, he was himself a 
member of the team for the final two years of the project. This doctor 
also served on the Medical School's internal review which cleared the 
project of any wrong-doing. 

In general, I believe we do not expect to have the individual who is 
in the defendant's box also sitting on the jury. 

Where in fact does the complicity begin and end? The Americtm 
Coffege of RodMogg did not find ongthing offensive in tiiese t riots end 
in foci termed tttem 'tteroic. ' 

What should we think about the long list of important medical 
journals which published the findings of these doctors over the years? 
How did their editors and readers regard the deaths they learned about in 
these reports? What were the attitudes of the local hospital 
authorities, the state licensing board? 

Wtig did ttte review committees ot tl C. foil? 

In Cincinnati, it can also be said, not one m. d. in the Medical 
School came forward to offer help to the faculty group studying the 
project in 1971, or simply to examine their results with an independent 
eye, though one research biologist did consult with our group — 
anonymously. 

No doctor in the greater medical community of the town openly 
expressed any doubts about what had been done. 

This is that wider complicity that should a^iann 'liS wmxk ihom 
anything else, end here in 1994 — when things are supposed to be 
'better' — the same situa'^on exists. Ho doctors coming frnntrord. 1 
believe it i^ correct to say that no reporter here in town has been able 
to find a single local doctor to examine what our faculty group found. 

in 1 965 an m. d. worlcing here for NiOSH got in touch with me about 
this project and examined some of the medical histories in my home one 
night. Since then this individual, David Egilman. has attempted to draw 
attention to these trials; he bears out the findings of the JFA and has 
publicly explained the state of medical knowledge about whole body 
radiation for cancer as it existed ot the time of the U. C. tests. He finds 



154 



5 
no reason for the doctors to hove believed thot rodio-resistont tumors 
such OS most of their patients suffered from could have been helped by 
the 'treatments" administered; the doses given, as deadly as they proved 
to be for many subjects, wm not high enough to reduce tumors or stop 
the spread of cancer. (MS^f^ 

Q. Why did the Medical School succeed in drawing a curtain over this 
whole affair in 1972? if the case against the doctors was as clear as it 
sounds, why was there not a lawsuit from subjects or a criminal 
investigation? 

One needs to understand the role of the media in Cincinnati (and in 
many other American towns). When the JFA press conference toolc place, 
the Woshingiott Post sent a reporter and the New York Times. A crew 
came from CBS. Our report was entered into the Congressi ono J Record \i,y^ 
Senator Kennedy. But there was no real coverage in Cincinnati ~ no way 
for any of the subjects or their families to know what had taken place. 
No one here broached the words 'radiation death.' 

The Medical School was never compelled to acknowledge any 
wrong-doing, and yet there was a tacit acknowledgement that such work 
could no longer be tolerated, for after all the project was stopped. No 
patient was irradiated after the fall of 1971. even though in the report 
thot would prove to be their last to the DOD. the doctors had announced 
their plans for more experiments in the year to come. 

Q. Was there a cancer study beiny carried out using these patients? 

There was no publication or report on cancer study during the 
eleven years of the project. 

No design for a cancer study was ever produced during the actual 
course of the experiments, although a study on cancer was issued after 
the fact and as a result of public revelations. There is no reference to 
on onyoiny concer project in the DOD reports. There is no evidence of 
close follow-up by the teom of the patients who survived more thon 60 
days. When the team had completed its radiation-injury tests, it seemed 
to have no more interest in the patients or their cancers. 

If there was a cancer project, who were the doctors, where is the 
design, by whom was it funded, what were Its results and how were they 
being reported? 

Q. Didn't some people at the university object to what you and your 
group were doing, feeling that the activities of your medical colleagues 
were none of your business? 



155 



6 
A. Of course. But surely events like these ore everyone's business. 

The people who used General Hospital were mostly Cincinnati 
working people; the great majority of them we now know were poying 
toxes; they were helping to poy the solaries of those of us in the JFA, 
ond the solories of the doctors. They were helping to fund this public 
hospital, not to mention the U. S. war machine of those days (as they do 
today). One can say thot their taxes helped to pay the salary of Ohio 
Bovemor John Gilligan, who came, not to their defense, but to the 
defense of the Medical School and assisted in the cover-up. Billigon 
convinced Senator Kennedy to drop U. C. from the hearinys on human 
experimentation which followed the U. C. revelations and those about 
Tuskegee (where beginning in the thirties men in Alabama with syphilis 
were denied treotment for their whole lifetimes, and many died of 
syphilis-related disease or became insane). 

I grew up among ordinary working people. My father worked for the 
railroads; my mother had only on eighth grade education. Many of us in 
the JFA were individuals who tended to side with common people against 
leaders and experts who wanted to control everything. I think people 
like ourselves ore still hoping that we in the U. S. con grow into a true 
democracy, that common citizens will take the lead and assume control 
over their own society. 

We are a class-ridden country, and actually it should not surprise 
us when our class conflict results in grievous actions like those of the 
U. C. doctors, actions, thot is, of one potent ond protected closs ogoinst 
another that is powerless. It wos o question here of a conflict between 
wealthy doctors and administrators ~ in a public institution insulated 
agoinst public accountobility — ond common working people who could 
not afford doctors of their own choosing. 

Q. What changes should come out of these revelations? 

A. First of all, surely it ought to occur to us that if we hod hod 
national health insurance of a single-payer kind, that is, of the Medicare 
type that allows people to choose their own doctors, these fellow 
citizens of ours would not have been trapped in o public hospital with 
nowhere else to turn. 

We need to see who is going to medical school, is it only the 
children of the wealthy? often the children of doctors, whose Incomes, 
after all, are within the top one or two percent of U. S. Incomes? There 
should be a public examination of all our admission practises around the 
country and the way that medical schools are funded and how doctors are 
trained. 



156 



7 

We ought to know, finolly now, that we >?w5^/hove ordinary citizens 
of oil walks of life well represented on medical boards, hospital boards, 
university boards and so on. 

In the same year (1972) that the U. C. radiation project was first 
exposed, a group colled the People's Health Movement was attempting to 
change the way the 6enera1 Hospital Board was formed. It was asking 
for a city amendment that would allow for common people to be elected 
to the board; many hospital workers were involved in this struggle, and a 
massive petition drive was launched to place an amendment to this 
effect on the ballot, but the city fathers saw to it that citiz^s were 
never able to vote on this measure. 

We need common citizens on the hospital board today and on the 
Board of Trustees of the university. At present the U. C. board is made 
up largely of wealthy business-people and attorneys. 

We need to struggle in every way we can to alter the general 
class-ism and elitism of our medical system (and indeed of our whole 
society). I believe we could have good doctors, ^/fffrdociors in fact, 
without the need to have doctors who are rich and powerful. Possibly in 
time we will even come to recognize that medicine for profit is not such 
a good idea anyway and that it doesn't have to be this way. Perhaps our 
current health care crisis and the recognized need for universal access 
to humane medicine will lead to some of the chonges we need. 

Q. Didn't we need, during the Cold War, to protect ourselves from our 
enemies abroad, and wasn't that why the U. C. doctors decided to do what 
they did? 

A. As^de f rom the fact that the Cold War was ~ as I see it anyway, and 
as%)o^i^d more Americans are cominy to realize ~ largely an 
indention of those who wonted to benefit from the arms race, we might 
ask this; // sacrifices were necessary^ why could not the invsstigaiors 
hmre experimented on other doctors ...oron thentsefresF 



MARTHA STEPHENS is a Professor of English at the University of 
Cincinnati, teaching modem literature, creative writing, and courses in 
literature and society. She Is the author of o study of the Eeorgio 
writer Flannery O'Connor, two novels set amongst working people in 
south Beorgia, and many shorter writings in fiction and on literature and 
the aris, as well as reporis on social Issues for newspapers and 
magazines. She has been involved in peace and justice movements in 
this country and in Central America. 



157 

Mr. Bryant. The Chair recognizes itself for 5 minutes. 

Dr. Egilman, in your experience did any of these patients have 
cancers that would benefit from cancer radiation treatment? 

Dr. Egilman. In some cases, if treated locally, some of them had 
cancers that were radioresistant to whole body radiation but would 
have responded to some local radiation, so that not all of the radi- 
ation they got was inappropriate. Only the whole body radiation 
they received was inappropriate. 

The three Ewing's cases got what was thought to be correct care 
at the time, and there were other studies on that. 

The total body radiation applied to the rest of the patients was 
inappropriate and had been tested before in the 1940s and 1950s 
and was known to be inappropriate and not to work. 

The possibility of using bone marrow replacement was an inter- 
esting possibility, but, of the 88 patients, it was only tried on 13. 
So it is hard to argue that the approach to cancer therapy using 
bone marrow replacements was the reason this study was done. 
And in those 13 it was universally a failure. 

I don't think you wait until 13, until you have stopped doing the 
work. I think one or two or three should be more than enough if 
it is a cancer treatment examination. 

Mr. Bryant. I guess you are saying the sum total of your lengthy 
study of this matter and your concern for 20 years about this mat- 
ter, the essence of it is that there was no informed consent, first; 
is that correct? 

Dr. Egilman. That is correct. 

Mr. Bryant. Because of illiteracy? 

Dr. Egilman. No. In part because of their mental status. Not 
only were they illiterate, but they also were ill. They could not fol- 
low simple instructions. 

For the military part of the experiment that related to the psy- 
chological testing, normally the questionnaire was self-adminis- 
tered. These patients could not fill out the self-administered ques- 
tionnaire as part of the psychological testing. It had to be adminis- 
tered by the investigator. So they were not able to follow simple in- 
structions because of their — for a variety of reasons. 

Mr. Bryant. Second, they weren't fully informed, I think you 
said, that they might die — there was some chance they might die 
within a few weeks. 

Dr. Egilman. It was recommended at the time that that is what 
the informed consent form said. 

Mr. Bryant. But it didn't say that? 

Dr. Egilman. It didn't say an3rthing about any risk. 

Mr. Bryant. You said it was recommended at the time. Who rec- 
ommended that? 

Dr. Egilman. That recommendation was by Dr. Shields in 1967. 

Mr. Bryant. And who is he? 

Dr. Egilman. He was a University of Cincinnati physician, a re- 
viewer of the research. 

Mr. Bryant. Is there a record 

Dr. Egilman. He wrote a letter. That is in his letter. 

Mr. Bryant. Is there any indication of why they chose not to in- 
clude his advice and follow his advice and include that information 
in the consent form? 



158 

Dr. Egilman. The research protocol was not finally approved at 
the University of Cincinnati until 1971, in August. There was a 
progressional approval given in 1967 but no final protocol was ap- 
proved until 1971. The research was allowed to continue without 
approval, as far as I could tell, reading Dr. Suskind's evaluation. 

Mr. Bryant. This is a little harsh, but it seems to be your con- 
clusion that they also carried out radiation tests on these individ- 
uals in order to obtain information for the Defense Department 
that were not therapeutic, that did not hold a promise of curing 
these people. Is that accurate? 

Dr. Egilman. Curing, for sure. They never even thought that a 
cure was a possibility. At best, it was thought — the best they can 
argue now was to reduce the size of the tumor and reduce pain. 
That is a hard argument because, as Dr. Suskind noted, there was 
never a protocol written to evaluate the effect of the therapy on 
palliation. There was never a study protocol to look at the effect 
of this therapy on what they now claim was the purpose. 

Mr. Bryant. When you say palliation, you mean reduction of 
pain? 

Dr. Egilman. It means reduction of pain. Or reduction of size of 
the tumor, et cetera. Or life expectancy. All that was done in retro- 
spect. This 1973 paper was a retrospective after the study was 
criticized by Dr. Stevens. 

Mr. Bryant. In the medical community, does the lack of such 
protocol lead to the absolute conclusion that was not the intent of 
their work at the time? 

Dr. Egilman. I don't know. Only a mind reader could know what 
was absolutely in their mind. I think that it wouldn't have been 
viewed as reasonable research. If there is no way to evaluate the 
question because there is no protocol for evaluating palliative ef- 
fects, how can you say it was research to look at the effects of 
palliation? 

That was Dr. Suskind's comment. The University's own analysis 
of the project said that there was no protocol that would allow one 
to evaluate the effects on palliation. What they tried to do was, 
when it was criticized, is they went back and quickly tried to put 
the data together. 

Mr. Bryant. You are asserting — I am not going to put words in 
your mouth; I am just trying to boil it down here — ^that basically 
they did military research on people who didn't know what was 
happening to them. That was not done for the benefit of the patient 
but for the benefit of the Defense Department, is that what you are 
saying? 

Dr. Egilman. That is what they say. And I am agreeing with 
them. That is what they said in their reports to the Defense De- 
partment, and I agree with them. 

Mr. Bryant. Maybe you better elaborate on that. You say that 
is what they say. 

Dr. Egilman. In the reports to the Defense Department they say 
the purpose of the research was to determine the effects of radi- 
ation on soldiers who might be in a nuclear war. That is what the 
researchers said. There is no cancer treatment mentioned in the 
first five or six years of this study at all, anywhere. Nowhere. It 
is their words, not mine. 



159 

Mr. Bryant. Mr. Mann. 

Mr. Mann. Thank you, Mr. Chairman. 

Dr. Egilman, just to clarify, could you lay out exactly where it 
is that you and Dr. Cox disagree? 

Dr. Egilman. Sure. I took a few notes. Thank you for that ques- 
tion. 

He said the doses were not meant to be lethal. Well — or not 
known to be lethal. That is not true. Neither was true. The doses 
were given up to 300 rads. It was known after Hiroshima — from 
Hiroshima that the lethal dose that would kill 50 percent of the 
population was 300 rads. 

Not only that, the researchers themselves used this information, 
combined with the research information at Oak Ridge where they 
were irradiating radiosensitive tumors, to publish a little abstract 
to help people understand how much it took to kill people. So they 
used their information to revise the estimate of how much it took 
to kill someone. So for sure they knew that the dose was sufficient 
to kill some of the people. 

They themselves found that eight of the people died as a result 
of the radiation. It is written as a cause of death at least in one 
of the medical charts that I have reviewed. I haven't reviewed them 
all. 

So certainly the researchers at the time knew that the doses 
could be lethal to some of the individuals. 

Mr. Mann. I am trying to focus — excuse me — on exactly where it 
is that you and Dr. Cox, who had no part in the project, disagree. 

Dr. Egilman. He said that the doses were not known to be le- 
thal. 

Mr. Mann. So, No. 1, he said the doses are not, and you say they 
are. 

Dr. Egilman. I say they are, and they were known to the re- 
searchers to be so. And I explained why he said it was reasonable 
to test the hypothesis that with whole body radiation what would 
not work. 

I disagree. It had previously been shown in the 1940s and 1950s 
not to work. Shields Warren wrote an article in Scientific Amer- 
ican, in case you weren't reading the general medical literature in 
1959, that specifically said whole body radiation should not be used 
for gastrointestinal tumors and other radioresistant tumors. He 
didn't even have to read the medical literature. You could get Sci- 
entific American at good magazine stores. Clearly, it was known to 
be ineffective by the time this research started and not to be indi- 
cated. 

And there are reasons for that. This radioresistant tumor takes 
a high dose to kill it. And if it is spread throughout the body, the 
high dose that will kill the tumor will kill the patient for sure. The 
dose that is are given here, 300 rads is a low number. If you have 
a cervical cancer or a breast cancer, you are going to get 5,000 
rads. That is what it takes to kill a radioresistant tumor. 

You couldn't give 5,000 rads to a person. You couldn't even give 
600 rads. Six hundred rads would kill everybody. 

So the thing is the radiosensitive tissue, the bone marrow, is af- 
fected by a much lower dose. You kill the radiosensitive tumor; you 
kill the patient. You can't get to a dose high enough to kill the 



160 

radioresistant tumor that is spread throughout the body. That was 
known and commented on and said in 1942. 

Mr. Mann. That is the second difference. What else? 

Dr. Egilman. Well, the informed consent, I think I explained 
that one. 

And then the issue about the fact that it is used now. Now, that 
is a use of 1990s standards looking at the 1960. It is used now be- 
cause we have perfected bone marrow transplants. It is a misrepre- 
sentation to say because whole body radiation is used now it was 
OK to use it then. We use it now because we know how to deal 
with the bone marrow suppression. We didn't then. 

Mr. Mann. How did we learn? 

Dr. Egilman. We didn't learn from this study. We learned from 
other studies. 

Mr. Mann. How do you go about moving from where you are to 
where you are today? You said something had been perfected. What 
is that? Not the result of experiments? 

Dr. Egilman. It was, but it was well-controlled studies that were 
looking at that for a particular reason. And when you do those 
studies you inform people, OK? 

I am not criticsd of doing research. I am critical of doing research 
that doesn't inform people of potential risks of the facts at the time 
that were known. 

It is true. What you said is true. Science must do research. Some 
of the research may be lethal to some of the people. And that was 
true then and that is true now. But when you do it you let them 
know. 

Mr. Mann. Anything else, in terms of differences between you 
and Dr. Cox? 

Dr. Egilman. Well, I guess the only one would have been some- 
thing he didn't say but something that came out. I think it would 
have been importsint to announce that the institution from whence 
he came did similar work funded by the same agency. That I think 
to me is a relevant piece of information in evaluating the com- 
ments. 

Mr. Mann. University of Texas? 

Dr. Egilman. M.D. Anderson is one of the institutions that got 
funding from the same agency to do the same work. I think that 
is important. 

Mr. Mann. Anything else? 

Dr. Egilman. That is all I can think of right now. 

Mr. Mann. Let me ask you to help me. I am, obviously, not a 
physician. I practiced law for 25 years. We have got a 
radiotherapist who, obviously, is trained in the field. As I under- 
stood your earlier testimony, you are an internist. You are a part- 
time faculty member at Brown, teaching medical ethics. Why 
should I believe you and not him or vice versa? 

Dr. Egilman. I think you need to read the documents. I think 
they speak for themselves. I read you from some of the patient 
records. The physicians at the time thought that in the case of Mr. 
Larkins that he should receive chemotherapy. They wrote that 
down. Those are their words, not mine. According to them radio- 
therapy was definitely out of the picture. 



161 

I don't think you need to be a physician to evaluate that. I don't 
think you need to be a physician to evaluate someone vomiting 3 
days and not getting treatment. I think you can read the records 
in most of these cases. 

Read the Suskind report. Ignore his conclusions. Read him for 
the facts. Suskind's analysis of the facts are quite similar to mine, 

Mr. Mann. His conclusion is quite different. 

Dr. Egilman. His conclusions are quite different, but the facts 
are the same. 

So if you believe that there is no disagreement about the facts, 
I trust the public to make up their own mind about the conclusions. 

Mr. Mann. I have and will, I am sure, continue to spend a lot 
of time trying to understand the facts. Your testimony is helpful. 
But it certainly is — I am unable at this point to reach a conclusion 
with quite the certainty that you can. This is part of the purpose 
of today and whatever happens after today. 

You talked about palliation, if that is the right pronunciation. 
The Suskind ad hoc committee report criticizes the protocol but 
doesn't disagree with the conclusions. 

Do you disagree with the conclusions of the final report that in 
some percentage of the patients the result of whole body radiation 
Nvas the tumor size was reduced? That in some percentage of pa- 
tients pain was lessened in some percentage the patients? The 
length of life after their whole body radiation was longer than what 
would have been projected for the alternative chemotherapy that 
might have been used? Or even what could have been projected 
had no whole body radiation or chemotherapy been applied? 

Dr. Egilman. Well, here I am an expert, being an epidemiologist 
in addition to an internist. 

In terms of the evaluation of the outcomes. Dr. Suskind says the 
data was insufficient to compare the outcomes of these patients to 
any other similar patients. 

But, of course, the historian part would refer you to the com- 
ments of, I think. Dr. Gaffney, who said that you couldn't evaluate 
the data and you couldn't hope to evaluate the data because there 
were no controls given and the cancers were all different types of 
cancers. And there weren't enough cancers to come up with any 
conclusions about what went on in terms of impacting on treat- 
ment. 

In order to answer the beginning part about whether you could 
retrospectively analyze this data for palliation, I don't know until 
I go through all the records. As you know, I only got the records 
on Friday, and I haven't had time to — I have gotten time to get a 
few things out of them, but I haven't had time to do a statistical 
analysis of those questions. 

But I don't think there is going to be any ability to really answer 
the question because you need to compare. How can you know if 
these people benefitted when there was no comparison group and 
there was no systematic way of recording the data? You just have 
to go throughout charts and see what you can get. 

I would need maybe — if the university wants to provide me with 
redacted records on 300 similar patients and we can see what was 
reported on those patients, we could compare how much pain those 
patients who had normal treatment versus the ones who had mili- 



162 

tary research performed on them did in terms of palliation. I think 
that is the only way to look at that question. 

Mr. Mann. As you know, the Suskind report says no plan for sys- 
tematic study of pgdliative effects was made in a retrospective re- 
view of the charts, following the data where elicited. So it looks like 
the Suskind group at least did that. Thirty percent had a decrease 
in tumor size of 50 percent or greater. That is objective, I guess. 

Dr. Egilman. I haven't seen — in the records I have seen, I don't 
see that information. So I don't know where it comes from. 

Mr. Mann. You have been working on this. Dr. Egilman. How 
long have you had an interest in this project and how did you first 
learn about the issues that we are discussing today? 

Dr. Egilman. I first learned about it when I was here in 1984 
from Dr. Stevens. 

Mr. Mann. I have other questions, but I will yield until the sec- 
ond round. 

Mr. Bryant. Mr. Portman. 

Mr. Portman. Thank you, Mr. Chairman. 

Thank you for being here. Dr. Egilman. 

You state very clearly in your testimony that cancer therapy was 
not the purpose of the research project. In fact, you went so far in 
your response to Mr. Bryant as to say there is no cancer research 
mentioned anjrwhere. 

I am looking at the 1958 response back from the Department of 
Defense regarding the proposal, which was really the approval of 
the project, and I quote, "Ajiy correlation of tumor response to total 
dose of irradiation by such means as proposed in this project would 
be of great value in the field of cancer." 

And it goes on to say, "In addition, if by such means the dose 
could be determined it would be of inestimable value in the case 
of atomic or nuclear warfare." 

Have you seen this? 

Dr. Egilman. I haven't, but that doesn't contradict what I have 
said. That is a reviewer's comment, isn't it? 

Mr. Portman. It is a comment from the DOD reviewing the re- 
search contract. 

Dr. Egilman. Right. It is not from the contract. It is not part of 
the proposal. 

I could read the proposal and say, gee, if I didn't know anjrthing 
about the previous research that had been done that showed this 
wasn't true, that it didn't work, and I looked at this, just relying 
on what the researchers said, I might think that, too. There is no 
evidence that that reviewer knew about the other articles that I 
talked about from 20 years before. 

Just because — I mean, could you look at the research now and 
say, gee, maybe it was helpful, maybe it could have been helpful, 
as Dr. Cox did? Of course. I have reviewed the previous research, 
and I know that if you had done that at the time you would have 
seen that this was not an effort in cancer treatment because it had 
already been tried and failed. 

Mr. Portman. This was in 1958. This wasn't looking retrospec- 
tively. I think it is inaccurate to say there is no mention anywhere 
in the record. This is something I just found looking in the record 
here. 



163 

The issue of informed consent is, of course, one of the ones that 
we are very interested in, and it is something that you addressed 
very articulately in your testimony, your written testimony. You 
have not had the opportunity to address what you view as the ac- 
tual standards in place at great length, but you mentioned various 
indicia of what that might have been, including a letter, as I under- 
stand, from 1967 from a physician at the General Hospital. 

What in your view were the standards that were in place, taking 
into account the Hippocratic Oath, taking into account all the var- 
ious standards that were out there, for that critical time period, 
particularly in the early 1960s? 

Dr. Egilman. The standards would have been to verbally inform 
them of the risks, at least, and to record for medical/legal reasons, 
if no other, that the person had been informed of those risks. And 
certainly by 1965 there was a university committee established 
that required formal signed informed consent forms. So that by 
then we know that the patient would have signed a consent form, 
and I think that I would agree with the people at the time who 
said that the risks should be explicit. 

All I can — I mean, I am not trying to put a 1990's face on this. 
I am telling you that Dr. Gaffney and others at the time said that 
the informed consent was inadequate and made specific rec- 
ommendations about how it would be changed. I think the rec- 
ommendations that they made at the time were the standard of the 
time and were adequate for the time and, in fact, would be ade- 
quate for now. 

Mr. PORTMAN. Written consent, as you note, I think, in your tes- 
timony, was used then. In fact, some have said that it antedated 
or predated that requirement or that recommendation to the uni- 
versity by 2 years. But in your response, again, to Chairman Bry- 
ant you had said that none were informed of possible risks. 

And we just talked about informed consent. We talked about how 
verbal consent in that period, particularly in the early 1960s, might 
have been appropriate. Dr. Cox, in fact, testified that there was, in 
his view, a requirement I think for verbal consent, not written, in 
1960, at least. 

I just wonder, do you know whether there was verbal consent or 
not during that period? You have said that people were not in- 
formed of the risks. Have you interviewed the doctors? Have you 
interviewed people to know whether there was, in fact, verbal con- 
sent during that period? 

Dr. Egilman. Well, the researchers in the Suskind report — Sus- 
kind comments on that. And let me just see what he says about 
that. "Patients and families were not informed about the possibility 
of transient nausea and vomiting since such symptoms may be in- 
duced by suggestion. Typically, such side effects can occur a few 
days after treatment." 

That is a quote from the paper that I just said. So the research- 
ers themselves said the patients weren't told of that. That was part 
of their study. It would have messed up the military aspects of the 
study. 

Mr. PoRTMAN. Part of your concern is about the demographics of 
the patient group, which is a concern of mine as well. We have 
heard from others that the study reflected the general patient pop- 



164 

ulation at the General Hospital. Would that change your view as 
to the study group? 

Dr. Egilman. No. This was a national problem. The DOD sought 
people here and at Charity and Tulane. NASA sought people at 
Oak Ridge. 

As far as I can tell, Afro-Americans were their first choice. When 
they couldn't find them, they accepted poor whites. I believe that 
that was a national policy, not a local policy, and that the site se- 
lections were not random by any means. 

I think they picked people who they thought were powerless, and 
that is why they picked people who had low educational level and 
who had low IQs. And I think that was also the reason for selecting 
African-Americans. They didn't want to be questioned by the pa- 
tients. 

If it was csmcer therapy, if people really thought that this was 
a way to cure cancer, there are lots of hospitals in this town that 
take care of affluent white people. Those hospitals could have been 
selected. 

Mr. PORTMAN. Just to be specific here, you said in a couple of in- 
stances that DOD selected the patients. That is not my under- 
standing and that certainly isn't what we are hearing from DOD 
in 1994. 

Dr. Egilman. They selected institutions. Institutions. I mean, 
look, you can say, oh, that is what happened to be at the institu- 
tion, which is apparently what you are saying. What I am telling 
you is it was no secret who was at the institution. It wasn't some 
random selection of institutions around the country that happened 
to serve predominantly poor people and African-Ajnericans. Those 
are the places they picked to do the work, for the most part. 

Mr. PoRTMAN. Having been associated with U.C. Hospital in 
1984, as you said, are there other research institutions, to your 
knowledge, at that time, in 1960, that would have been appropriate 
for this kind of research? 

Dr. Egilman. I don't think the research was appropriate. You 
mean in 1984? What is the time 

Mr. PoRTMAN. I am saying you have some knowledge of the Uni- 
versity Hospital and General Hospital. You indicate that DOD se- 
lected the hospital. 

It is my understanding that it was an unsolicited proposal, one; 
and, two, that at that time, in 1960 — and I would certainly think 
that continues today — ^that the then General Hospital, University 
Hospital, was the preeminent research facility in Cincinnati. Is 
that your understanding or not? 

Dr. Egilman. That is my understanding. 

But in the paper yesterday I saw some advertisements for people. 
If you had sinus infections, there is a research protocol. And you 
can go to two or three different places and get in a research proto- 
col for sinus infections. 

So if you have a real research project and you want to do a lot 
of patients — after all, this was 88 patients over 12 years, not real 
fast. You need a lot more patients than that to do a research 
project. You could always advertise. And if you can't advertise, if 
the DOD won't fund your small ad in the Inquirer, you could al- 
ways call your colleagues up at the other institutions. 



165 

Certainly Children's was able to appropriately send patients from 
Children's to the University of Cincinnati. 

These patients, as I saw from the records, took a bus. Presum- 
ably, the bus went from affluent areas of town to the university. 
It didn't just go from the university to the poor areas of town. So 
if it was good cancer research, unfortunately, the white, affluent 
people in town were deprived of the ability to participate in it. 

Mr. PORTMAN. Thank you. I have no further questions. 

Mr. Bryant. Dr. Egilman, I am curious to know your view of the 
Federal Government's role in this. As I understand it, the Univer- 
sity of Cincinnati solicited the support of the Defense Department 
in funding this study. 

Dr. Egilman. Right. 

Mr. Bryant. Is that correct? 

Dr. Egilman. That is what I understand. 

Mr. Bryant. And the Defense Department contributed to it, as- 
suming I am sure — and correct me if this assumption is wrong — 
that they would not be the only source of funding. 

Dr. Egilman. That part I don't know. I think they were not the 
only source. I think that the University used this other general re- 
search fund — 

By the way, that is another area of disagreement. I don't think 
NIH ever approved this consent form. There was general research, 
as I understand, at the University, and some of those funded the 
treatment. 

Now, some of those funds — and also it is here from some of the 
charts — medicare funding was used. Now, it is my understanding — 
I don't know if this was true at the time. Medicare doesn't fund 
clinical research, only treatment. 

So that one of the Federal questions I think that is involved here 
is were medicare and medicare funds diverted to clinical research. 
That is a Federal question. 

Mr. Bryant. In view of all of that, doesn't that auger a little bit 
against the assertion that this is explicitly military research being 
done on people? I mean, it was — after all, the University of Cin- 
cinnati solicited help in funding this from the Department of De- 
fense but, as you just stated, had other sources involved in funding 
the research as well. 

Dr. Egilman. The research would not have gone on like this had 
the military not wanted it to go on. The fact that civilian money 
were used doesn't mitigate the fact that it appears completely to 
have been done for military purposes and not medical purposes. 
The fact that they diverted money from general research monies or 
from medicare or medicaid funding doesn't seem to mitigate the 
purpose of the research or change the purpose of the research. 

It might have been funded by some private foundation and still 
had a military purpose. The purpose doesn't depend on the funding. 
I don't criticize it because the Defense Department funded it. 

Mr. Bryant. Do you think that this totally lacked therapeutic 
purpose? 

Dr. Egilman. Oh, yes. 

Mr. Bryant. You don't think there was ever any intent to de- 
velop a way to solve cancer problems through whole body irradia- 
tion? 



166 

Dr. Egilman. Not at this time, not with this therapeutic modal- 
ity, not when there were only 13 of the 75 who received bone mar- 
row transplants. 

What about the other 75? It was known not to work on them. 

Mr. Bryant. That is a pretty strong position you take. You are 
basically saying Dr. Saenger and those others that attempted in 
subsequent years to characterize this as a way to try to find a way 
to cure or make more comfortable cancer patients were not telling 
the truth and what they were really tr3dng to do was get informa- 
tion for the armed services. 

Dr. Egilman. Well, look, no cancer therapy study was published 
until it was criticized. No cancer therapy protocol was written until 
1966, and that was limited to the bone marrow radiation combina- 
tion. 

So, I mean, as they say, the facts speak for themselves. No re- 
search started until the Defense Department agreed to fund it, and 
it was stopped when the Defense Department withdrew funding. 

I don't think those are all coincidences. Perhaps I am a cynic, but 
I think there is a relationship there. 

Mr. Bryant. Very well. 

Mr. Mann. 

Mr. Mann. Dr. Stevens, you indicated you had a couple of rec- 
ommendations that you were interested in making. I would be 
pleased to hear that. 

Dr. Stephens. All right. If I might just make a few other com- 
ments first. 

Mr. Mann. Sure. 

Dr. Stephens. I would just like to clear this up. 

The doctors did not give 300 rads of total body radiation, as I am 
sure they will remind us. Three hundred referred to partial body 
radiation. And there was only one person who received 250 rads of 
total body radiation. The high dosages were 150 and 200 rads. 

With regard to the cancer study, if I might just read part of the 
statement I gave you: 

Was a cancer study being carried out? 

There was no publication or report on cancer study during the 11 years of the 
study. No design for cancer study was ever produced diuing the actual course of the 
experiments, although a study on cancer was issued after the fact and as a result 
of pubhc revelations. There is no reference to an ongoing cancer project in the DOD 
reports. There is no evidence of close follow-up by the team of the patients who sur- 
vived more than 60 days — and often less than that. 

When the team had completed its radiation injury test it seemed to have no more 
interest in the patients or their cancers. If there was a cancer project, who were 
the doctors? Where is the design? By whom was it funded? What were its results 
and how were they being reported? 

I know it has been said that we were in the cold war and maybe 
we needed to do this kind of research to protect ourselves against 
enemies abroad. But I say even if that was true — and sometimes 
I think the cold war was an invention of people who wanted to ben- 
efit from the arms race anyway — but if that was true, then maybe 
these doctors should have experimented on other doctors or on 
themselves, which is not unprecedented, actually, in the history of 
human experimentation. 

But — I am sorry. You asked me 



167 

Mr. Mann. You indicated, Dr. Stevens, you had a couple of rec- 
ommendations for us. 

Dr. Stephens. Yes, I did. I think if we regard these experiments 
just as an anomaly of the cold war we may be missing the point. 
I think there was abuse of patients in those days, and there is 
abuse today. 

Let's consider it this way. If people had had in those days na- 
tional health insurance, and especially of the medicare or single- 
payer kind where you can choose your doctors, they would not have 
been trapped in a charity hospital, or even, let's say, in a cheap 
HMO, which may also today not be giving good care. 

That is — I want to look at what we are doing today and see what 
this project of the sixties helps us to understand about today. 

I would appeal to you, the three of you, to consider, this matter 
closely, to search your hearts and minds to see if you can support 
a people's national health insurance as many of your colleagues are 
doing. I am not quite sure whether any of you are already support- 
ing a single-payer system. It would have solved the problem back 
then. This would not have happened. 

Mr. Bryant. Will the gentleman yield? 

I guess I don't understand — and I definitely do not want to get 
into a discussion about national health insurance here. I have had 
two weeks of that at home, and I would like to talk today about 
this matter. 

But I don't understand what the point you are making is. We are 
talking here about experimentation which was defended by the 
University as having been for therapeutic purposes. Many of the 
facts seem to indicate otherwise, as has been laid out by Dr. 
Egilman. 

Dr. Stephens. With health insurance, people would not have had 
to go to that public hospital. These people had no choice. They had 
no national health insurance such as nearly all developed countries 
did have at that time and do have today. 

Mr. Bryant. You are saying that — ^I guess you are ignoring or 
finding less than — I guess you are assuming that the statements 
that these people had a hopeless circumstance and were willing to 
undergo very risky treatment was not credible. 

Dr. Stephens. No, I don't see any contradiction there. I am just 
saying that they would have been able to go to their own private 
doctors. They wouldn't have been the victims of this kind of medi- 
cal violence by researchers. That is a recommendation I have. 

Mr. Mann. Did you have a second one. Dr. Stephens? 

Dr. Stephens. Yes, I do. I think neither one of these may be ter- 
ribly popular, but I hope some people at least will think about 
them. I think that we need to have common citizens, users of insti- 
tutions, on all our bodies on hospital boards, on review boards, on 
university boards, where now we have almost entirely wealthy 
businessmen and attorneys. 

After all, the university board could have played a part in stop- 
ping these tests much sooner than they did, and in recent months 
they could have responded to the desperate pleas of families to 
know what happened to them several months before they did re- 
spond. They only responded because of enormous public pressure 
on them and when they had no choice. They allowed over 600 peo- 



168 

pie to wonder for many weeks whether their families had been irra- 
diated or not. 

So I think if we had had users, common citizens, nonspecialists, 
on these boards, on the board of the hospital, for instance, things 
might have been different. And I just appeal to you that whatever 
legislation regarding medical matters comes before you, surely this 
is something to consider. I think we must learn these kinds of 
things, from what happened in that public hospital. 

Mr. Mann. Thank you. 

I have one more question of Dr. Egilman. You refer to this 1950 
letter from Dr. Hamilton. Could you share a copy of that with us? 
And who was he? 

Dr. Egilman. He was a physician in California. He wrote the let- 
ter to Shields Warren, who was the head of the Atomic Energy 
Commission. And he was discussing the research needs similar to 
the ones that were conducted here. 

Mr. Mann. Was he a researcher? 

Dr. Egilman. He was a physician researcher. He is the gen- 
tleman who started injecting healthy patients with plutonium. 

Mr. Mann. Hamilton did? 

Dr. Egilman. Hamilton, before he wrote that letter. He wasn't 
concerned about the ethics. He was concerned that it might become 
public and that the public would be concerned about the ethics. 

Mr. Mann. Thank you, Mr. Chairman. 

Mr. Bryant. Mr. Portman. 

Mr. Portman. Thank you, Mr. Chairman. 

Dr. Stephens, thank you for being here today. Just a couple of 
quick questions. 

No. 1, you had said in response to Mr. Bryant, my view is that 
many of the patients were not terminally ill. 

Dr. Stephens. Right. 

Mr. Portman. If you could just tell us a little further what you 
base that on, number one, and then tell us whether you have any 
medical training, whether you have had any experience in that 
field. I am not sure what your field is. I believe you are a professor 
at the University in English. 

Dr. Stephens. Right. 

Mr. Portman. If you could just expand on that in terms of the 
question as to whether the patients were terminally ill or not. 

Dr. Stephens. Well, I didn't bring the file of patient histories 
that I have with me. I can't skim through them and see just how 
many might be considered to be in that category. But I do remem- 
ber very clearly that two people stand out that would not have 
seemed, I think, to most people to be terminal. 

The woman I mentioned, was irradiated in the first group of pa- 
tients and lived 5 years after receiving the high dose of radiation, 
at least 5 years. We don't have her date of death. It is hard to con- 
sider that she was terminal. 

And then I remember another woman shortly after that irradia- 
tion who lived over 3 years. And there were a good many who lived 
a couple of years. Again, these are people who might have died. 
Some of those people received the high doses that were killing peo- 
ple. You either begin to get better or die, generally, within about 
40 days. 



169 

I am sorry I don't have figures on how many people this might 
be. Of course, in some cases it is hard to tell. 

We have discovered already, by the way, that there are problems 
and errors in the patient histories that I originally examined 22 
years ago when I wrote the JFA report. When I examine the origi- 
nal summaries and we compare them to what we now have in the 
medical records, there are discrepancies. 

Mr. PORTMAN. Getting back to my favorite issue of informed con- 
sent, just to further flesh out, again, your comments to Mr. Bryant 
in that regard, you had said that there is absolutely no evidence 
of informed consent. Some patients 

Dr. Stephens. Of the first 5 years. 

Mr. PoRTMAN. Of the first 5 years. Some patients, of course, in 
those 5 years said no. Why did they say no? 

Dr. Stephens. I am sorry. I am not aware of that. 

Mr. PoRTMAN. The records that we have indicate that some pa- 
tients were asked to participate, and they said that they didn't 
want to. 

Dr. Stephens. Well, I am sorry. I didn't remember that. 

Mr. Portman. I just wonder if there was no information given 
as to the risks and benefits, how that decision would have been 

Dr. Stephens. Where do you find that? Is that in one of the so- 
called DOD reports? 

Mr. Portman. It is in several documents that I have seen, Dr. 
Saenger's report. 

Dr. Stephens. Oh, Dr. Saenger's. OK. Well 

Mr. Portman. We will find that out and let you know. I think 
I saw it in the ad hoc report, but I am not sure. 

Dr. Stephens. I would like to see it. 

Mr. Portman. It is an interesting issue in terms of the consent. 
There was no written consent, as you say, during that time period. 

Dr. Stephens. Yes, no evidence of any kind of consent. Let's 
don't forget that in their own reports the doctors say the patients 
were told "they were being treated for their disease." That is a di- 
rect quote. I have included this in my original analysis. There are 
several such direct quotes, more than several, in those first five 
years of reports to the DOD. A number of times we read the pa- 
tient is being told he is being treated for his disease. 

Mr. Portman. Thank you. Professor Stephens. 

No further questions, Mr. Chairman. 

Mr. Bryant. I have no further questions. 

Would you like to add anything? We would be happy to hear it. 

Dr. Egilman. Just with respect to the last question. 

Dr. Suskind noted that the researchers excluded terminal pa- 
tients from the study. "Some of the reasons for patient rejection in- 
cluded advanced stage of malignancies leading to disorientation, 
stupor and/or coma and terminal advanced malignant disease in 
which the life expectancy was only a few weeks." 

Mr. Bryant. Leading to a conclusion that 

Dr. Egilman. Well, we know the therapy didn't help them, so 
there is only two conclusions. Some of the people lived a consider- 
able amount of time. We know the therapy didn't help them. There 
is only one conclusion left then, that they weren't terminal when 
they were irradiated. That is the only conclusion. 



170 

Otherwise, there are two possibilities. One is they were terminal, 
and the therapy helped them. If that is true, then we have spent 
20 years — ^we were wrong. They were right. But we have denied 
people this great therapy for 22 years. I don't think that is what 
we have been doing. 

Clearly, the patients were not terminal. The therapy didn't help 
them. And that is from the life expectancy on the charts. 

Mr. Mann. Dr. Egilman, you started that comment quoting some- 
thing from Dr. Suskind's report. Where is that? 

Dr. Egilman. Page 27. 

Mr. Mann. Yes, sir. 

Dr. Egilman. Wait a minute. 

Mr. Mann. You were making the point that patients who were 
so advanced that their life expectancy was only a few weeks were 
excluded from the study. 

Dr. Egilman. That is what Suskind said. 

Mr. Mann. But you are not disagreeing — at least the information 
that we have — or are you disagreeing — all the information we have 
indicates you weren't even qualified to be a part of the study unless 
your cancer was advanced and you were terminal and gdtemative 
therapies were not thought to be beneficial. 

Dr. Egilman. Well, you have to be a little careful here. We are 
all terminal. Congressman Mann. We will all die. 

Terminal from a medical sense means, as they defined it, within 
several weeks or certainly within six months. And many of the pa- 
tients, perhaps most of the patients, would not have been consid- 
ered to be terminal within weeks or months, and so, therefore, 
would not be defined as medically terminal. They were terminal 
the way we are all terminal. We all die. It is a question of how 
soon. 

Mr. Mann. Are you suggesting that having cancer was not a pre- 
requisite for being in the study? 

Dr. Egilman. No. They all had cancer. And they all had cancer 
that was likely to result in their death. It is a question of how long. 
People can live with cancer for months, years. 

Mr. Mann. It was more subtle than that. It was cancer that had 
spread in the body, as I understand it. And it was cancer that, at 
least if you accept the premise of the research, was not going to 
be — chemotherapy was not going to do an3rthing except perhaps ar- 
rest the speed of the cancer, the speed of death. 

And they argue — and this is part of what we are trying to find 
out. They argue that the whole body irradiation in some instances 
was more effective £ind resulted in a longer length of life than the 
alternatives that were available. 

Dr. Egilman. Okay. Let me deal with those one at a time. 

First, there was therapy, as — 25 or 26 of these patients had colon 
cancers. As you heard from my reading, the researchers themselves 
were aware of the fact that there was palliative treatment for the 
colon cancers. And they themselves wrote that that is the preferred 
treatment in 1971. That is their opinion. That has got to be the 
current standard at the time. 

The second question is how reasonable is it to think that whole 
body radiation might have helped the others. For that I refer you 



171 

to what I already read about the previous studies that had looked 
at this and those patients that had shown it wasn't effective. 

In addition, you have heard that radiosensitive tissues, bone 
marrow, get destroyed with 100 to 300 rads, certainly 400 or 500 
rads. You have also heard that radioresistant tumors like GI can- 
cer and breast, the ones that were treated here, take thousands of 
rads to kill the tissue, to kill the cancer. 

So it was not medically reasonable, it was not scientifically rea- 
sonable to think that giving someone 300 rads half body or 150 
rads whole body would in any way touch the radioresistant malig- 
nant spread of cancer without wiping out their bone marrow first. 

The dose differences between radioresistant and radiosensitive 
are quite high, thousands versus hundreds. So there wasn't a medi- 
cal rationale and scientific rationale, and that fact was noted in 
1942. 

I am not telling you something that I figured out last week. I am 
telling you something that was published. This scientific rationale, 
this medical thinking, was published by Graver in 1943. 

Dr. Stephens. May I reply again to your question about my own 
specialty not being medicine? 

Mr. PORTMAN. Sure. 

Dr. Stephens. May I do so? 

Mr. PoRTMAN. Yes, ma'am. 

Dr. Stephens. It relates to my recommendation that we have 
common citizens on all boards that decide how hospitals and uni- 
versities and medical services shall be organized. If we can't do 
that, we are not a democracy, in my opinion. 

I am an English professor, all right. Medicine is not a magic 
science. It is not a body of knowledge different from all other bodies 
of knowledge that only certified people can understand. 

Mr. PORTMAN. I appreciate that response. I asked that question, 
in the context of your statement as to the patients being terminally 
ill or not, which is in my mind a medical issue and a diagnostic 
issue. 

We asked about — where it said the patients had not agreed, on 
page 26 of the ad hoc report, you see something about two patients 
did not agree to be treated. That is what I was referring to. 

Dr. Stephens. May I say that I am extremely happy that I have 
been able to work lately with Dr. Egilman, because, of course, I am 
not a physician. There is a great deal I don't know about cancer. 

Mr. Portman. Thank you very much. 

Mr. Bryant. Thank you very much for your testimony. 

Thank you. Dr. Egilman, for traveling here today. 

At this time we will ask our fourth panelist to come forward, 
which consists of Dr. Eugene Saenger, Professor Emeritus of Radi- 
ology, University of Gincinnati. 

Dr. Saenger, thank you very much for being here today. At this 
time, we would ask you to proceed. 

STATEMENT OF EUGE^fE SAENGER, M.D., PROFESSOR 
EMERITUS OF RADIOLOGY, UNIVERSITY OF CINCINNATI 

Dr. Saenger. Thank you, Mr. Chairman. 



172 

There is a great deal to respond to in this hearing, and I will 
begin by stressing the important points that we wish to bring out 
concerning our work. 

One purpose of the study was the treatment of patients with far 
advanced cancer to whom the goal was the relief of pain, shrinkage 
of cancer and improvement in well-being. 

A second purpose was to study the systematic effects of radiation 
on the patient, the systemic effects. 

The third and most important, treatment was given only if bene- 
fit to the patient was anticipated. 

Patients were chiefly from the General Hospital. Selection was 
based only on the presence of adv£inced cancer and where no other 
therapy was considered to be as or more effective than the avsdl- 
able chemotherapy. 

Race, IQ or socioeconomic standing were not selection factors. 
Treatment was paid for by the Cincinnati General Hospital and the 
National Institutes of Health. No Department of Defense funds 
were used for treatment or patient care or decisions regarding ther- 
apy or patient reimbursement. Patients were told that the treat- 
ment might help them and were cautioned that it might not. Some 
patients chose not to be treated. 

There was nothing secret about our work. There was nothing se- 
cret as to its being conducted. There was nothing secret about the 
findings obtained. 

The primary goal of the study was to improve the treatment and 
general clinical management by increasing, if possible, survival of 
patients with advanced cancer and palliation of s3anptoms. 

In addition, observations in laboratory tests were carried out to 
seek effects of radiation on cancer patients and on the changes that 
could be ascribed to radiation. 

The background for this project originated in my observations 
over the previous 20 years that cancer patients treated with radi- 
ation might be benefited by more careful evaluation of the effects 
of this kind of treatment. The scientific indications that these goals 
might be achievable were based on two levels of evidence, one from 
animal studies and one from human studies. 

Animal studies indicated better tumor regression by localized ra- 
diation followed by total body irradiation for lymphoma and car- 
cinoma in mice. Human studies for treatment of advanced cancer, 
for far advanced solid tumors prior to 1960 suggested the value of 
total body radiation. 

It was employed in several American medical centers and inter- 
nationally. Treatment was given with success in relieving pain, 
shrinking tumors and, in some cases, prolonging survival. 

A major reason that we could begin this work resulted from sev- 
eral developments. First, the cobalt 60 teletherapy unit was in- 
stalled in General Hospital in 1958, the first in the State of Ohio. 

Harold Perry, M.D., our first full-time radiation therapist, came 
from Memorial Sloan-Kettering Cancer Institute in New York and 
was familiar with total and partial body radiation techniques. 
James G. Kereiakes, Ph.D., a physicist, joined the department in 
1959. He performed the calculations regarding the administration 
of the doses prescribed by the treating physici^. 



173 

I believe that there could be implications of this treatment for in- 
dividuals exposed to radiation under other circumstances. 

In 1958, I submitted an unsolicited application to DOD because 
there had been no studies on the metabolic effects of radiation, and 
funds were available. The Army recognized the importance of can- 
cer therapy in this regard. 

This proposal was reviewed by J. A. Isherwood, M.D., for the 
Army Medical Research and Development Command. And, to 
quote. 

Any correlation of tumor response to total dose of irradiation by such means as 
proposed in this project would be of great value in the field of cancer. 

In addition, if by some means such as those proposed accurate knowledge of the 
total dose of radiation received could be determined, it would be of inestimable value 
in case of atomic disaster or nuclear warfare. 

Patients were not recruited. Patients were referred for this form 
of therapy mostly from the tumor clinic, outpatient or inpatient. I 
was not involved in patient selection or in determination of the ex- 
tent of dose or the regions involved. These decisions were made 
solely by the attending physicians, internists and surgeons £ind by 
radiotherapists. 

There were 24 patients entered into the study who were not 
given total or partial body irradiation. Some were rejected because 
it was thought the patient would not benefit. Several patients and 
their families declined treatment. Some were treated by other 
means. 

In 1962, we developed for the DOD a document concerning the 
eligibility of patients for therapy — in 1962. And it stated. 

There is a reasonable chance of therapeutic benefit to the patient. The likeUhood 
of damage to the patient is not greater than that encountered from comparable ther- 
apy of another type. The facihties for support of the patient and complication of 
treatment offer all possible medical services for successful maintenance of the pa- 
tient's well-being. 

Race was not a factor in selection, only the type of cancer and 
extent. A statistical analysis done only after the program was ter- 
minated confirmed that the patients in this study did not differ 
from the patient population of the Cincinnati General Hospital. 

Again, IQ was not a factor in patient selection. 

The subject of informed consent — I believe we sort of fell in a pe- 
riod when there was a change in the general understanding of in- 
formed consent. In our study, informed consent for therapy was ob- 
tained by the attending physicians. In the 1940s and 1950s, in- 
formed consent was verbal, except for the general brief signed in- 
formed consent required by the hospital from all patients who were 
hospitalized for whatever services they required. 

In this project, the purpose and actual treatment and the pos- 
sible outcomes were discussed with the patient and often included 
family members. 

In April, 1965, this project began the use of written informed 
consent 2 years before it was required in our medical center. It 
clearly indicated that the risks of treatment were discussed. 

One criticism of our work stems from the instructions of the at- 
tend personnel not to inquire concerning nausea, vomiting and di- 
arrhea in the first few days after treatment. Since both nausea and 
vomiting could be induced by suggestive questions, we requested 



174 

that no questions be asked as to how the patient felt within these 
first few days. 

This restriction did not in any way restrict the administration of 
drugs such as Compazine to relieve symptoms. Of interest is that, 
after treatment, 44 percent of the patients who were treated had 
no nausea and vomiting, 27 percent noted it for three hours or less, 
and 14 percent had symptoms for 6 hours or less. These responses 
are comparable to chemotherapy at the time. 

Funding. As noted earlier, most costs of treatment were paid by 
the Cincinnati General Hospital. This amounts to about $483,000. 
There were no professional costs or physicians fees for patient care. 
Some funding was obtained from the NIH through the General 
Clinical Research Center of our hospital, which was a unit funded 
by the NIH. 

The records of each patient in the hospital on that service were 
submitted to the NIH and approved. In addition, several of the 
postgraduate fellows in another NIH training grant of our depart- 
ment participated in this study. 

DOD funding was utilized solely for observation of patient symp- 
toms and for the extensive laboratory tests carried out. DOD funds 
had no relation to choice of dose, choice of patient or patient care 
in any way. No patient was compensated or reimbursed or paid for 
treatment. 

The total DOD contract was about $671,000. 

Mortalities. In the group of patients who received radiation there 
were three categories in which there were enough patients to com- 
pare with other patients in our hospital treated differently or with 
comparable groups described in the refereed medical literature. 
The cancers were those of the breast, lung, and colon. The death 
rates were comparable to those treated by other means. This can 
be seen clearly in our 1973 paper and the graphs that are there. 

An important question is whether radiation was the factor lead- 
ing to the early death of a patient. These patients had far advanced 
cancers which were growing exponentially. In the course of disease, 
the patients received chemotherapy and/or local radiation therapy 
both before and immediately after total or partial body irradiation. 
For these reasons, it is not possible to identify a single form of 
treatment or the rapid growth of cancer as being the single contrib- 
uting cause of death. It most likely would be the rate of growth of 
cancer itself. 

There were 20 cases in which patients survived longer than 1 
year. Except for the one patient with Ewing's sarcoma who remains 
alive after 25 years, the longest survivor lived 9 years. Two other 
relatively long survivors lived 5 years each. 

Palliation was successful with relief of pain in 31 percent of pa- 
tients. There was decrease in tumor size in 31 percent and an in- 
crease in well-being found in 30 percent. No change was observed 
in 31 percent. 

Because of the radiation induced hematological depression, bone 
marrow storage and reinfusion began in 1964. With the improve- 
ment in techniques to include harvest of the marrow under general 
anesthesia and replacement immediately after total body irradia- 
tion, it became possible to avoid the characteristic depression of the 
white cells in five patients. 



175 

This promising development was stopped at the time of the ter- 
mination of the contract. This pioneering use of bone marrow has 
been and is being used today. 

Review by others. The UC Faculty Research Committee. Our pro- 
tocol was submitted to this newly formed committee in March 
1966. Provisional approval was given in 1967, with recommenda- 
tions for review of therapeutic efficacy, bone marrow infusion as a 
supportive measure and some revisions in the study design. At no 
time was the project disapproved by the faculty research committee 
as it received exhaustive and critical reviews, and it was approved 
again in 1971. 

The ad hoc committee of the University of Cincinnati began a 
complete review of this project in 1971. Among the findings were 
that phase III studies should be initiated with better criteria for 
the determination of palliative effects and that bone marrow trans- 
plantation should be pursued. The study was judged to be adequate 
for support of the critically ill patients because of the development 
of skilled team management, especially with the help of a psychia- 
trist and psychologist, coupled with home visits. 

The American College of Radiology. You have already heard of 
the three gentlemen who visited us. This distinguished group made 
two visits to our hospital. Their major findings were as follows: 

One, the project is validly conceived, stated, executed, controlled and followed up. 

Two, the patient's selection based on clinical consideration conforms with good 
medical practice. 

Three, the records, publications, the patient-follow-up are voluminous and com- 
mendable. 

Four, the procedure used for obtaining patient consent is valid, thorough and con- 
sistent with the recommendations of the National Institutes of Health and with the 
practice of most cancer centers. 

And, five, should this project come before the Senate or one of its committees in 
some fashion, we would urge your support for its continuation. 

At the request of Senator Edward Kennedy, the Government Ac- 
counting Office reviewed the accounts of the Cincinnati General 
Hospital to determine whether there had been any intermingling of 
DOD funds used for patient care since we have pointed out from 
the start of our work that no DOD funds would be used for this 
purpose. 

An excerpt from the letter dated May 26, 1972, from the Comp- 
troller General to Senator Kennedy, follows: 

Concerning the contract with the University of Cincinnati, officials of the Defense 
Nuclear Agency stated that the cost of radiation treatment and patient care have 
not been borne by their agency. They stated also that funds of the Defense Nuclear 
Agency have been used only to pay for supplementary laboratory analyses of pa- 
tients who had received whole body irradiation in order for the Defense Nuclear 
Agency to gain information in areas that were relevant to nationjil defense. 

From the National Institutes of Health, D.T. Chalkley, Ph.D., 
Chief, Office of Protection from Risks, was very supportive of our 
work. In a letter copied to Senators Nunn and Talmadge, he com- 
ments that. 

It is to be regretted that this incident has halted what promised to be a very sig- 
nificant addition to our armamentarium against metastatic cancer. 

He also wrote directly to Senator Nunn, pointing out that, "The 
patients were treated individually for the diseases that they had." 



176 

Secrecy. This study received widespread publicity in the 1970's. 
We responded to all questions about it at the time, including an 
open press conference. The study resulted in 13 published papers, 
nine DASA reports and 24 scientific presentations. 

What about the status of total body irradiation and partial body 
irradiation since 1971? It is apparently a common misunderstand- 
ing that the use of these methods of treatment for therapy has 
been discontinued. This statement is incorrect. 

Doses. Our doses were at a low level of 100 to 200 rads total vol- 
ume. I might state there — that in the documents that you have 
there is a typo. It says, 300. It should be 200. And up to 300 rads 
partial body radiation between 1960 and 1970. 

In other centers, doses now range from 600 to 1,200 rads in sin- 
gle or divided doses of total body and with sequential hemibody ra- 
diation in these same dose ranges. 

Fractionation, that is the splitting of these doses over a period 
of several days, has replaced single large doses of, say, 1,200 rads, 
because of the complication of radiation pneumonitis. 

Among the solid tumors treated during these two decades have 
been cancers of the breast, prostate, lung, colon, and some sarco- 
mas. 

At the University of Cincinnati Department of Radiation Oncol- 
ogy, from 1979 on, total and partial body radiation were adminis- 
tered to adults and children for leukemias, lymphomas, cancers of 
the breast, prostate, and neuroblastoma. 

Nationally, uses of total body and partial body irradiation have 
grown steadily since 1970 and are used more widely today than 
ever before. 

To conclude this presentation of several decades, I speak to you 
as a survivor of cancer, having been treated with radiation and sur- 
gery. 

Our work has contributed significantly to the better treatment of 
patients with far advanced cancer and to our better understanding 
of the effect of radiation on humans in a time when nuclear war- 
fare once again seems possible. 

Thank you. 

Mr. Bryant. Thank you, Dr. Saenger. 

[The prepared statement of Dr. Saenger follows:] 



177 



Statement of Eugene L. Saenger, M. D. 
Before the House Judiciary Committee 
Subcommittee on Administrative Law and Governmental 

Relations 

April 11, 1994 

Cincinnati, Ohio 



E.L Saenger, M.D. 

April 11. 1994 
Pagel 



178 



SUMMARY 



Several important points are presented summarizing our worli: 

a One purpose of the study was the treatment of patients with far advanced cancer 
for whom tKfe goal was the relief of pain, shrinkage of cancer and improvement in well being. 

b. A second purpose was to study the systemic effects of radiation on the patient. 

c. Treatment was given only if benefit to the patient was anticipated. 

d. Patients were chiefly from the Cincinnati General Hospital. Selection was made 
only based on the presence of advanced cancer and where no other therapy was considered to be 
as or more efficacious than that currently available chemotherapy. Race, IQ, or socioeconomic 
standing were not selection factors. 

e. Treatment was paid for by Cincinnati General Hospital and the National Institutes 
of Health. No Department of Defense funds were used for treatment or patient care or decisions 
regarding therapy or patient reimbursement. 

f. Patients were told that the treatment might help them and were cautioned that it 
might not. Some patients chose not to be treated. 

g. There was nothing secret about our work. There was nothing secret as to its 
being conducted. There was nothing secret at>out the findings obtained. 



E.L Saenger, M.D. 

April 11. 1994 
Page 2 



179 



I am Eugene L Saenger, M. D. of Cincinnati. It is a privilege for me to speak before tills 
distinguistied sub-committee of the Judiciary Committee of the U.S. House of Representatives to 
present a summary of our work on the treatment of far advanced cancer and the effects of wide 
field radiation therapy, work which I was privileged to direct and the results of which I am 
proud. The participation and support of the highly qualified physicians, allied scientists and 
associated health professionals is gratefully acknowledged. My Curriculum Vitae is attached. 
(See Appendix 1) 

I am a graduate of Walnut Hills High School, Harvard College, 1938, cum laude and University 
of Cincinnati, College of Medicine 1942. My training in Radiology was at Cincinnati General 
Hospital completed in 1 945. I am a Diplomate of the American Board of Radiology and the 
American Board of Nuclear Medicine. 

My major appointments at University of Cincinnati College of Medicine include rising from 
Assistant Professor of Radiology to Professor of Radiology from 1949-1987 and Professor 
Emeritus since then. I was the founder and director of (what continues today) the Eugene L 
Saenger Radioisotope Laboratory from 1950 to 1987. I was Radiology Therapist at Children's 
Hospital from 1947 to 1987. 

I have given over 40 guest and invited lectures In the U.S. and elsewhere. I have received the 
De Hevesy Nuclear Pioneer Award of the Society of Nuclear Medicine and the Gold Medal of the 
Radiological Society of North America and the Daniel Drake Award of the University of 
Cincinnati College of Medicine, these being the highest honors of these organizations. 

My consultant appointments to my government encompass both domestic and international 
sen/ice, and include among others requests from the Department of Justice; Department of 
Energy; Environmental Protection Agency; Department of Health and Human Services; National 
Institutes of Health; Department of Defense; Food and Drug Administration: International Atomic 
Energy Agency; Oak Ridge Affiliated Universities; Surgeon General of the Air Force; the U. S. 
Public Health Service and numerous government administered hospitals. Additionally, I was 
proud to serve my country as an officer in the United States Army, attaining the rank of Major 
prior to my honorable discharge. 

My principal appointments at the University of Cincinnati College of Medicine range from 
Assistant Professor of Radiology in 1949 rising to Professor, and from 1987, the rank of 
Professor Emeritus. I am a member of 29 medical and scientific societies and the Founding 
President of the Society for Medical Decision Making. In addition to t>eing an honorary member 
of the National Council on Radiation Protection and Measurement (NCRP), I delivered the Sixth 
Lauriston Taylor Lecture-the highest honor of this organization. The NCRP is an organization 
chartered by Congress that develops recommendations for radiation safety used by Federal 
Agencies for protection of the public. 

E.L Saenger, M.D. 

April 11, 1994 
Page 3 



180 



With my colleagues, I am the author of 187 publications in the scientific literature, the 
majority being in refereed journals. 



I. introduction 

Several important points are presented summarizing our work: 

A. One purpose of the study was the treatment of patients with far advanced cancer 
for whom the goal was the relief of pain, shrinltage of cancer and improvement in well being. 

B. A second purpose was to study the systemic effects of radiation on the patient. 

Q Treatment was given only if benefit to the patient was anticipated. 

D. Patients were chiefly from the Cincinnati General Hospital. Selection was based 
only on the presence of advanced cancer and where no other therapy was considered to be as or 
more efficacious than then available chemotherapy. Race, IQ, or socioeconomic standing were 
not selection factors. 

E Treatment was paid for by Cincinnati General Hospital and the National Institutes 
of Health. No Department of Defense funds were used for treatment or patient care or decisions 
regarding therapy or patient reimbursement. 

F. Patients were told that the treatment might help them and were cautioned that it 
might not Some patients chose not to be treated. 

G There was nothing secret about our wotk. There was nothing secret as to its 
being conducted. There was nothing secret about the findings obtained. 



II. What Was The Purpose of The Total Body Irradiation (TBI)/Partial Body 
Irradiation (PBI) Study: 

The primary goal of the study was to Improve the treatment and general clinical management by 
increasing, if possible, survival of patients with advanced cancer and palliation of symptoms. 
(Palliation is treatment directed at relief but not cure.) In addition, observations and 
laboratory tests were carried out to seek effects of radiation on cancer patients and on the 
changes that could be ascribed to radiation. 

The palliative effects of TBI were considered to be at least equal to and very likely to be superior 
to the chemotherapy available in the period from 1960 - 1970. Also the treatment methods 



E.L Saenger, M.D. 

April 11. 1994 
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181 



were thought to be less stressful to the patients than chemotherapy then In use, especially in 
terms of initial symptomatology following administration of the dose, as for example, the 
painful mouth ulcers from methotrexate and 5-fluorouracil, drugs used at that time. 

The background for this project originated in my observations over the prior 20 years that 
cancer patients treated with radiation might be benefitted by a more careful evaluation of the 
effects of this kind of treatment on the total patient. 

It seemed to me at that time that the approach to the total management of the cancer patients 
receiving radiation therapy was not as well studied as was that of the same patient who would be 
treated surgically. In addition, the effect on the cancer patient of doses of radiation given 
through large fields in relation to systemic effects was not being adequately considered, even 
though much work was being done on the radiation effects on the tumor and its immediate 
substrate. 

The scientific indications that these goals might be achievable were based on two levels of 
evidence one from animal studies and one from human studies. 

a) Animal studies indicated better tumor regression when total body 
irradiation was preceded by localized radiation than when localized radiation therapy was given 
alone both for lymphoma and carcinoma in mice. 

b ) Studies in human beings: Human studies for treatment of far advanced 
solid tumors prior to 1960 suggested the value of TBI. It was employed in several American 
centers and internationally. Treatment was given with success in relieving pain, shrinking 
tumors and, in some cases, prolonging survival. (See Appendix 2) 

A major reason that we could begin TBI and PBI resulted from several important developments. 
The cobalt 60 teletherapy unit was installed at General Hospital in 1958, the first in Ohio. 
Harold Perry, M. D. was the first full time radiation therapist at our hospital. He had come 
from Memorial Sloan Kettering Cancer Center in New York Hospital and was familiar with TBI 
and PBI techniques and indicators. James G. Kereiakes, Ph.D., a physicist, joined the 
Department of Radiology in 1 959. He calculated the doses, dose rate and distribution of 
radiation. 

I believed that there could be implications from this treatment for well individuals exposed to 
radiation under other circumstances. In 1958, I submitted an unsolicited application to DOD 
because there had t>een no studies on the metabolic effects of radiation and funds were available. 
This proposal was reviewed by J. A. Isherwood, M. D. for the Army Medical Research and 
Development Command. He made the following comments: 'Any correlation of tumor response 
to total dose of irradiation by such means as proposed in this project would be of great value in 
the fiekJ of cancer. In addition if by some means such as those proposed accurate knowledge of 
the total dose of radiation received could t>e determined it would be of inestimable value in case 
of atomic disaster or nuclear warfare.' (See Appendix 3) 



E.L Saenger, M.D. 

April 11. 1994 
Pages 



182 



III. The Study 

A. Typical of medical investigations, this study progressed through phases. These 
phases are defined as follows: 

Phase I studies are to determine whether the treatment is toxic. 

Phase II is to determine in patients without controls but with measurable 
disease, whether the treatment is effective. Our studies included Phase II. 

Only then are Phase III studies with controls and ideally with randomization 
conducted to determine therapeutic values. Although a Phase III study was proposed, we did not 
reach this level. 

B. Patient selection: Patients were not recruited. Patients were referred for 
consideration for this form of therapy mostly from the Tumor Clinic (outpatient) and the 
Tumor Service (in-patient). I was not involved in patient selection or in determination of 
extent of therapy or dosage. These decisions were made solely by the attending physicians, 
internists and surgeons, and by radiation therapists. There were 24 patients entered into the 
study who were not given TBI or PBI. Some were rejected because it was thought that the 
patient would not benefit. Several patients and their families declined treatment. 

1. Eligibility for therapy was spelled out in our 1962 document to DOD: 

a There is a reasonable chance of therapeutic benefit to the patient. 

b. The likelihood of damage to the patient is not greater than that 
encountered from comparable therapy of another type. 

c. The facilities for support of the patient and complications of 
treatment offer all possible medical services for successful maintenance of the patient's well 
being. 

2. Race was not a factor in selection-only the type of cancer and its extent. 
A statistical analysis, done only after the program was terminated, confirmed that the patients 
in this study did not differ from the patient population of Cincinnati General Hospital. 

3. IQ was not a factor in patient selection. 

IV. Informed Consent 

As in selection of patients, informed consent for therapy was obtained by the attending 
physicians. 



E.L Saenger, M.D. 

April 11. 1994 
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183 



In the 1 940's and 1 950's informed consent was veibal except for the general tirief informed 
consent required by the hospital from all patients to be hospitalized irrespective of the 
treatment to be administered. 

In this project, the purpose and actual treatmet^t and the possible outcomes were discussed with 
the patient and often included family members. 

In April 1965, the use of written informed consent, tx>th for radiation and bone marrow 
harvesting and reinfusion, were developed by this project. These forms clearly indicated that 
risks of treatment were discussed. At that time, DHEW and DOD did not require written 
informed consent. As a result of a number of helpful suggestions from the University of 
Cincinnati Faculty Research Committee, several revisions to the form were made between 1 967 
and 1971 (See Appendix 4). Furthermore, this written informed consent that we developed 
preceded any written requirements of the University of Cincinnati Medical Center by two (2) 
years. 

One criticism of our work stemmed from the instructions to the attending personnel not to 
inquire concerning nausea, vomiting and diarrhea in the first few days after treatment. We 
were particulariy interested in the frequency of these manifestations. Since both nausea and 
vomiting coukj be induced by suggestive questions, we requested that no questions be asked as to 
how the patient felt. This restriction did not in any way restrict the administration of drugs 
such as Compazine to relieve symptoms. This care Is amply documented in patients' charts. Of 
interest is that after treatment 39 patients (44%) had no nausea and vomiting, that 23 (27%) 
had symptoms for three (3) hours or less and that 12 patients (14%) had symptoms for six 
(6) hours or less. These responses are comparable to chemotherapy at the time, e.g., 
methotrexate, 5-fluorouacil and Chlorambucil. 

V. Funding 

As noted earlier, most costs of treatment were paid by Cincinnati General Hospital. An estimate 
of the expenditures for direct patient care for about 3,804 days at about $114 per day with 
some additional cost estimates gave a total calculated amount of $483,222. There were no 
professional costs or physician fees for patient care. 

Some funding was obtained from the NIH. Some patients were maintained on the General Clinical 
Research Center of Cincinnati General Hospital; this unit was supported by NIH. The protocols 
and records of each patient so hospitalized were submitted to the NIH and approved. In addition, 
several of the Post Graduate Fellows supported by the Radiation Training Grant of the National 
institute of General Medical Sciences (NIH) participated in some phases of the DASA program. 

DOD funding was utilized solely for observation of patient symptoms and signs and for the 
extensive laboratory tests (See Appendix 5). DOD funds had no relation to choice of dose, choice 
of patient or patient care, in any way. No patient was compensated or reimbursed or paid for 



E.L Saenger, M.D. 

April 11. 1994 
Pager 



184 



treatment. A Congressional General Accounting Office audit documented all of this in 1972. The 
total DOD contract for FY 1960 through FY 1971 was $671,482.79. 

VI. Success of the TBI study 

Mortality. In the group of patients who received radiation, there were three categories in which 
there were enough patients to compare with other patients of the Cincinnati General Hospital 
treated differently or with comparable groups reported in the refereed medical literature. The 
cancers were those of the breast, lung and colon. The death rates were comparable to those 
treated by other means. 

An important question is whether radiation was the factor leading to the early death of a patient. 
These patients had far advanced cancers which were growing exponentially. In the course of the 
disease, patients received chemotherapy and/or localized radiation therapy both before and 
immediately after TBI or FBI. For these reasons, it is not possible to identify a single form of 
treatment or the rapid growth of cancer as being the single contributing cause of death. It most 
likely would be the rate of growth of the cancer itself. 

There were 20 cases in which patients survived longer than one year. Except for the one patient 
with Ewing's tumor who remains alive after 25 years, the longest survivor lived 9 years. Two 
other relatively long survivors lived five years. 

Palliation was successful with relief of pain in 31% of patients. Some decrease in tumor size 
occurred in 31% and an increase in well being was found in 30%. No change was observed in 
31%. (In some patients there was more than one indication of improvement; thus the 
percentages exceed 100%). (See Appendix 6). 

Because of radiation induced hematological depression, autologous bone marrow storage and 
reinfusion began in 1964. With improvement in technique to include harvest of the marrow 
under general anesthesia and replacement immediately after TBI it became possible to avoid the 
characteristic depression of the white blood cells in five patients. This promising development 
was stopped at the time of termination of the contract. 

VII. Review by Others 

A Faculty Research Committee. Our protocol was submitted to this newly 
formed committee in March of 1966. Provisional approval was given in 1967 with 
recommendations for review of therapeutic efficacy, bone marrow infusion as a supportive 
measure and some revision in the study design. At no time was the project disapproved by the 
Faculty Research Committee as if received exhaustive and critical reviews. 

B. The ad hoc Committee of the University of Cincinnati (the Suskind 
Report) undertook a complete review of the TBI project. Among the findings were that Phase III 
studies should be initiated with better criteria for the determination of palliative effects and 



E.L Saenger, M.D. 

April 11. 1994 
Pages 



185 



that bone marrow transplantation be pursued. The study was judged to be adequate for support of 
the critically ill patients because of the development of skilled team management especially wKh 
the help of the psychiatrist and psychologist coupled with home visits. 

C. American College of Radiology. At the request of Senator Mike Gravel, the 
American College of Radiotogy formed an expert committee of Dr. Henry Kaplan. Chairman of 
Radiology at Stanford University, Dr. Frank Hendrickson, Chairman of Radiation Therapy at 
Rush-Presbyterian Hospital, Chicago and Dr. Samuel Taylor, III, a medical oncologist at Rush- 
Presbyterian Hospital, Chicago. This distinguished group made two visits to our hospital. Their 
major findings were as follows: 

1 . The project is validly conceived, stated, executed, controlled and 

followed up. 

2 . The process of patient selectk}n based on clink:al considerations 
conforms with good medical practice. 

3. The records, publications and patient follow-up are voluminous 
and commendable. 

4. The procedure used for obtaining patient consent is valid, thorough 
and consistent with the recommendations of the National Institutes of Health and with the 
practice of most cancer centers. 

5. Should this project come before the Senate or one of its 
committees in some fashion, we would urge your support for its continuation. (See Appendix 7) 

D. At the request of Senator Edward Kennedy, the Government Accounting 
OfTice reviewed the accounts of the Cincinnati General Hospital to determine whether there had 
been any intermingling of DOD funds used for patient care, since we had pointed out from the 
start of our work that no DOD funds would be used for this purpose. 

An excerpt from the letter dated May 26, 1972 from the Comptroller General to Senator 
Kennedy follows: "Concerning the contract with the University of Cincinnati, officials of the 
Defense Nuclear Agency stated that the cost of radiation treatment and patient care had not been 
borne by their agency. They stated also that funds of the Defense Nuclear Agency had bteen used 
only to pay for supplementary laboratory analyses of patients who had received whole t»dy 
irradiation in order for the Defense Nuclear Agency to gain information in areas that were 
relative to national defense.' (See Appendix 8) 

E National Institutes of Health (DHEW). D.T. Chalkley, Ph.D., Chief, Office 
for Protection from Risks, Office of the Director NIH, was very supportive of our work. In a 
letter copied to Senators Nunn and Talmadge, he comments that "It is to be regretted that this 
inckJent has halted what promised to t)e a very significant addition to our armamentarium 
against metastatic cancer." He also wrote directly to Senator Nunn pointing out that "...the 
patients were treated individually for the diseases they had." (See Appendix 9) 

F. Secrecy. This study received widespread publicity in the early 70"s. We 
responded to all questions about it at the time including at an open press conference. The study 

E.L Saenger, M.D. 

April 11, 1994 
Page 9 



186 

resulted in numerous unclassified presentations at open medical meetings and in published 
papers and reports (See Appendix 10). 



VIII. Total Body Irradiation & Partial Body Irradiation Since 1971 

It is apparently a common misunderstanding that the use of TBI/PBI as a therapeutic agent has 
been discontinued. In the period from 1970 to the present there have been major changes in the 
use of TBI and RBI (See Appendix 2). Doses have risen from the low levels of 100-300 rad TBI 
and up to 300 rad FBI used by us from 1960 to 1970. Doses now range from 600 to 1200 rad 
in single or divided doses of TBI and with sequential HBI in these same dose ranges. 
Fractionation has replaced single large doses (1200 rad) because of the complication of 
radiation pneumonitis. Among the solid tumors treated during these two decades have been 
cancer of breast, prostate, lung, colon and some sarcomas. 

At the University of Cincinnati Department of Radiation Oncology beginning in 1979, TBI and 
FBI were administered to adults and children for leukemias, lymphomas, cancers of breast and 
prostate and neuroblastoma. Non-malignant diseases treated included aplastic anemia and 
congenital anomalies. 



E.L Saenger, M.D. 

April 11, 1994 
Page 10 



187 



CURRICULUM VITAE 

EUGENE L. SAENGER, M.D, 
PROFESSOR EMERITUS OF RADIOLOGY 
UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE 



Personal 

Date of Birth: March 5, 1917 

Place of Birth: Cincinnati, Ohio (Hamilton County) 

Home Address: 9160 Given Road 

Cincinnati, Ohio 45243 
(513) 793-1373 

Office Address: University of Cincinnati Hospital 
234 Goodman Street - M.L. #569 
Cincinnati, Ohio 45267-0569 
Telephone: (513) 558-9042 
Facsimile: (513) 558-4715 

Married: Sue R. Saenger 

Education; 

A.B. - Cum Laude, Biochemical Sciences, Harvard University, 1938 

M.D. - University of Cincinnati College of Medicine, 1942 

Internship, Cincinnati General Hospital, 1942-43 

Assistant Resident and Resident in Radiology, Cincinnati General 
Hospital, 1943-46 

Diplomate, American Board of Radiology, 1946 

Diplomate, American Board of Nuclear Medicine, 1972 

Appointments 

Professor Emeritus of Radiology, University of Cincinnati College 
of Medicine, September 1987 

Professor of Radiology, University of Cincinnati College of 
Medicine, 1962-1987 

Director, Eugene L. Saenger Radioisotope Laboratory, University 
of Cincinnati College of Medicine, 1950-1987 

Vice-chairman, Department of Radiology, University of Cincinnati 
College of Medicine, 1975-1987 



188 



Assistant and Associate Professor of Radiology, University of 
Cincinnati College of Medicine, 1949-1962 

Radiation Therapist, Children's Hospital Medical Center, 
Cincinnati, Ohio, 1947-Present 

Major, U.S. Army Medical Corps; Chief, Radioisotope Laboratory, 
Brooke Army Hospital, Ft. Sam Houston, Texas, 1953-1955 

Consultant in Radiology, Brooke Army Hospital, Ft. Sam Houston, 
Texas, 1956-1977 

Consultant, Oak Ridge Operations Office, Division of Biology, 
U.S. Atomic Energy Commission, Oak Ridge, Tennessee, 
1958-Present 

Consultant, Division of Compliance, U.S. Atomic Energy Commission 
(now U.S. Nuclear Regulatory Commission), Washington, D.C., 
1962-1987 

Consultant in Radiology, Lackland AFB Hospital, Lackland AFB, 
Texas, 1959-1975 

Consultant, Radiological Health Research Activities, USPHS, Taft 
Engineering Center, 1964-1969 

Consultant, Medical Advisory Committee, Defense Atomic Support 
Agency, Washington, D.C., 1965-1971 

Representative for State of Ohio to the Medical Liaison Officer 
Network, Environmental Protection Agency, 1968-1984 

Consultant on Radiology Training, DHEW/PHS, National Institute of 
General Medical Sciences, NIH, Bethesda, Maryland, 1967-1970 

Consultant to the Office of the Director, DHHS/PHS/FDA, Center 
for Devices and Radiological Health, Rockville, Maryland, 
1969-Present 

Consultant, Radiation Bio-Effects and Epidemiology Advisory 
Committee, DHEVJ/PHS, Washington, D.C., 1970-1971 

Consultant, Radiation Science & Protection Fellowship Board, Oak 
Ridge Associated Universities, Oak Ridge, Tennessee, 
1970-Present 

Consultant to Surgeon General, U.S. Air Force, in Nuclear 
Medicine, 1970-1975 

Consultant, Wright-Patterson Air Force Base, Ohio, 1977-Present 

Board of Directors, Center of Science and Industry, Cincinnati, 
Ohio, 1964-1969 



189 



Chairman, Radiation Safety Committee, University of Cincinnati, 
1964-1985; Member, 1985-1989 

Board of Trustees, Community Chest & Council, Cincinnati, Ohio, 
19G4-1970; Executive Committee, 1970 

President, Public Health Federation, Cincinnati, Ohio, 1965-1969 

Executive Committee, Health Planning Association of the Central 
Ohio River Valley (CORVA) , 1970-1972 

Environmental Health Planning Committee of the Central Ohio River 
Valley (CORVA) 1970-1972 

Advisory Committee to the Federal Radiation Council, National 
Academy of Sciences, Washington, D.C., 1964-1972 

Associate Editor, Journal of Nuclear Medicine , 1960-1970 

Program Director in Radiological Sciences (National Cancer 
Institute and National Institute of General Medical 
Sciences, NIH) Training Program, University of Cincinnati, 
1959-1970 

Program Director for studies in metabolism of radiation following 
whole-body irradiation (Department of Defense) 1960-1971 

Co-investigator, Biomedical Computing Center, University of 
Cincinnati College of Medicine, 1962-1966 

Chairman, Cancer Control Council, Public Health Federation, 
Cincinnati, Ohio, 1961-1968 

Board of Directors, Cancer Control Council, Cincinnati, Ohio, 
1964-1970 

Board of Governors, Ohio Valley Chapter of the Arthritis and 
Rheumatism Foundation, 1961-1968 

Board, Hamilton County Chapter of the ;'jnerican Cancer Society, 
1963-1967 

Governor's Advisory Board on Atomic Energy, State of Ohio, 
1963-1972 

Member, Medical Advisory Committee to Department of Health, State 
of Ohio, 1962-1969 

Member, Honorary Editorial Advisory Board of the Journal of 
Applied Radiology , 1972 

Radiation Research Society, Member - Finance Committee, 1977-1981 



190 



Health Physics Societv, Chairman - Legislation Committee, 
1968-1969 

Health Physics Society, Member - Hoard of Directors, 1966-1969 

National Committee on Radiation Protection, National Bureau of 
Standards, Member Subcommittee on Radium, Cobalt-60 and 
Cesium-137, 1952-1965 

National Council on Radiation Protection and Measurements (NCRP) , 
Board of Directors, 1967-1983; Honorary Member status 1983 

NCRP, Member - Subcommittee for Revision of Handbook 73, 1966 

NCRP, Chairman - Budget and Finance Committee, 1968-1973 

NCRP, Chairman - Scientific Committee #29 on Brachytherapy 
Devices, 1968-1972 

NCPJ>, Chairman - Ad Hoc Thyroid Blocking Committee, 1972-1978 

NCRP, Member - Scientific Committee #44 on Radiation Associated 
with Medical Exaoninations , 1973-Present 

NCRP, Chairman - Resources Development Program, 1986-1990 

American Roentgen Ray Society, Representative to the National 
Council on Radiation Protection and Measurements, 
1960-Present 

Society of Nuclear Medicine, Member - Board of Directors, 
1966-1969 

Society of Nuclear Medicine, Member - Radiation Protection 
Committee, 1966-1969 

Society of Nuclear Medicine, Chairman - Subcommittee on Post 
Graduate Training in Nuclear Medicine, 1969-1971 

Society of Nuclear Medicine, Member - By-Laws Committee, 
1969-1972 

Society of Nuclear Medicine, Member - Committee on Education and 
Training, 1969-1971 

Society of Nuclear Medicine, Chairman - Committee on Public 
Health and Efficacy, 1972-1984; Member, 1984-1987 

Society of Nuclear Medicine, Member - Subcommittee on Risks of 
Low Level Ionizing Radiation, 1980-Present 

Society of Nuclear Medicine, Principal Investigator - U.S. 

Department of Energy Contract, "The Efficacy of Clinical 
Diagnostic Procedures Utilized in Nuclear Medicine", 
1977-1983 



191 



American College of Radiology, Menber - Subcommittee on 

Radiological Aspects of Disaster Planning, 1964-1969 

American College of Radiology, Member - Commission on Radiologic 
Units, Standards, and Protection, 1969-1988; Chairman, 
1909-Present 

American College of Radiology, Chairman - Committee on Research 
and Development in Nuclear Medicine, 1969-1972 

American College of Radioloay, Member - Commission on Public 
Health, 1969-1971 

American College of Radiology, Member - Subcommittee on Nuclear 
Medicine Technology, 1969-1975 

American College of Radiology, Member - Committee on Quality 
Assurance and Efficacy, 1972-Present 

American College of Radiology, Member - Committee on Radiation 
Physics, 1977-1982 

American College of Radiology, Member - Commission on Nuclear 
Medicine, 1977-1986 

American College of Radiology, Member - Medical Legal Coirjnittee, 
1986-Present 

National Consultant, Office of the Radiation Safety Officer of 
the Veterans Administration, 1974 

Member, Ad Hoc Committee to Evaluate the Health and Safety 

Aspects of Pu in the Environment Adjacent to the Mound 
Laboratory, 1975 

Argonne National Laboratory, Member - Review Committee for the 

Radiological and Environmental Research Division, 1976-1977 

International Commission on Radiological Protection, Member - 
Committee #3 on Protection in Medicine, 1977-1984 

Federated Council of Nuclear Medicine Organizations, 

Representative - American College of Nuclear Physicians, 
1977-1980 

Federated Council of Nuclear Medicine Organizations, 
Secretary-Treasurer, 1978-1980 

BEIR Report (The Effects on Populations of Exposure to Low Levels 
of Ionizing Radiation), National Academy of Sciences, 
National Research Council, Member of Committee, 1972 



192 



Reactor Safety Study (WASE-l'SOO) , An Assessment of Accident Risks 
in U.S. Commercial Nuclear Pov/er Plants, Appendix IV, United 
States Nuclear Regulatory Commission, October 1975, Member- 
Advisory Group on Health Effects 

Consultant, Pan American Health Organization, World Health 
Organization, Mexico City, Mexico, December 1980 

Co-founder and President, Society for Medical Decision Making, 
September 1979; Historian 1979-1985 

Member, Oversight Committee on the Radioepidemiologic Tables 
(OCRET) , National Research Council, Commission on Life 
Sciences, August 1983-January 1985 

Member, U.S. Department of Energy Ad Hoc Committee on Neutron 
Quality Factor, January-December 1985 

Chairman, Advisory Committee of the Charles M. Barrett Cancer 
Center, University of Cincinnati, 1984-1986 

Health Effects Model for Nuclear Pov/er Plant A^ccident Consequence 
Analysis, (NUREG/CR-4214) Prepared by Sandia National 
Laboratories, Albuquerque, NM for the Division of Risk 
Analysis and Operations, U.S. Nuclear Regulatory Ccmnission, 
July 1985, Member, Advisory Committee 

Consultant, 7th Medical Command, U.S. Army, Heidelberg, V;est 
Germany, I lay 1986 

Member, AMA Committee on Non-Military Radiation Emergencit^s, 
August 1986; conference November 19-21, 198C 

Director, Region I, Cancer Control Consortium of Ohio (CCCO) , 
1985-1989 

Honorary member, Medical Academy of SR Croatia, February 1988 

Ad Hoc Consultant to: 

U.S. Department of Justice 
U.S. Department of Energy 
U.S. Environmental Protection Agency 
U.S. Department of Defense 

U.S. Department of Health and Human Services, Food and Drug 
Administration 

International Atomic Energy Agency 

Member, Expert Committee of IAEA to the USSR to evaluate 
the late et fects of Chernobyl, July 1990 

Marquis ' Who ' s Who 

American Men and Women of Science 



193 



Lectureships: 

Annual Oration, "Radiologists, Medical Radiation and the Public 
Health", presented at the Radiological Society of North America, 
Chicago, Illinois, December 4, 1968 

Aubrey O. Hampton Lecture, "Radiation 1971 - Just How Safe?", 
Harvard Medical School, Massachusetts General Hospital, Boston, 
April 4, 1971 

Wright H. Langham Memorial Lecture, "Radiation Accidents - 3 
Decades of Facts and Fancies" , University of Kentucky Medical 
Center, Lexington, Kentucky, November 15, 1977 

Annual Failla Lecture, "Benefits vs Risks of Medical Radiation: 
New Concepts and Problems" , presented to the Greater New York 
Chapter of the Health Physics Society, Columbia University, Nev; 
York, December 7, 1977 

Brookhaven National Laboratory, "'Safe' Tracer Dose in Human 
Experimentation", Islip, New York, April 7, 1978 

Tenth Annual Conference on Radiation Control, "Efficacy of 
Nuclear Medicine Procedures", Harrisburg, Pennsylvania, April 
30-May 4, 1978 

Harvard University School of Public Health, Planning for Nuclear 
Emergencies , (seminar) , "Medical-Legal Aspects of Radiation 
Exposure", Boston, Massachusetts, May 8-12, 1978 (through 1986) 

Society of Nuclear Medicine Refresher Course, "Radiation Effects 
and Radiation Protection", Anaheim, California, June 1978 

Radiological Society of North American Refresher Course, "Recent 
Advances in Radiation Epidemiology.", Chicago, Illinois, November 
1978 (repeated 1979, 1980) 

Food and Drug Administration, Bureau of Radiological Health, 
"Efficacy Studies in Lung Scanning: Design and Implementation", 
Rockville, Maryland, March 20, 1979 

Armed Forces Radiobiological Research Institute (AFRRI) , "The 
Experienced Effects of Ionizing Radiation on the Body", Bethesda, 
Maryland, May 23, 1979 

Guest Lecturer, "Efficacy and Efficiency of the Diagnostic 
Application of Radiation and Radionuclides", organized by the 
Government of the Federal Republic of Germany and the World 
Health Organization, Neuherberg, West Germany, December 5-7, 1979 

Literary Club, "Perceptions of Risk", Cincinnati, Ohio, February 
18, 1980 



194 



Society of Nuclear Medicine Continuing Education Course, "Nuclear 
Power, Nuclear Medicine and the Public", Detroit, Michigan, June 
25, 1980 

Guest Lecturer, "Low Level Radiation Risks", University of Texas 
Health Science Center, Houston, Texas, July 25, 1980 

Guest Lecturer, Nuclear Radiation Risks - A Utility-Medical 
Dialogue , "Case Histories of Lawsuits for Overexposure", 
sponsored by the International Institute of Safety and Health, 
Washington, D.C., September 22-23, 1980 

"Hospital Preparation for the Management of Radiation Accidents" , 
course presented by the E.L. Saenger Radioisotope Laboratory, 
September 29-30, 1980 (repeated September, 1981) 

Guest Lecturer and Banquet Address, Los Alamos Scientific 
Laboratory, Life Sciences Symposium, "Medical Aspects of 
Radiation: Radiation Burns", Los Alamos, New Mexico, October 
8-10, 1980 

"Aspects of Nuclear Medicine", Medical Society of the District of 
Columbia Annual Scientific Assembly, White Sulphur Springs, West 
Virginia, October 24-26, 1980 

Society of Nuclear Medicine Refresher Course, "What Nuclear 
Medicine Professionals Should Know About Nuclear VJarf are" , Las 
Vegas, Nevada, June 17, 1981 

Guest Lecturer and Member of Faculty, "Regional Seminar on 
General Procedures to Manage Persons Receiving Whole or Partial 
Body Irradiation" , co-sponsored by the Pan American Health 
Organization and the Government of Brazil, Itaipava, Brazil, 
December 11-22, 1982 

Guest Lecturer, "The Pole of the Physician in Medico-legal Claims 
Associated with Radiation Injury", sponsored by the 
Pacific-Sierra Corporation, in Albuquerque, New Mexico, March 
4-6, 1982 

Sixth Annual Lauriston S. Taylor Lecture, "Ethics, Trade-Offs and 
Medical Radiation", presented to the National Council on 
Radiation Protection and Measurements, Washinaton, D.C. , April 6, 
1982 

"High Level Radiation", invited Grand Rounds presentation, Hamot 
Medical Center, Erie, Pennsylvania, April 29, 1982 

Guest Lecturer, "Medical Management of Radiation Injuries", 
sponsored by the Radiation Management Corporation of 
Philadelphia, in Atlantic City, New Jersey, May 6, 1982 



195 



Guest Lecturer, "Medical Management of Radiation Casualties", 
sponsored by the REMS Corporation of Albuquerque, in South Haven, 
Michigan, May 24-26, 1982 

Society of Nuclear Medicine Continuing Education Course, "ALARA - 
What is Reasonable", Miami Beach, Florida, June 17, 1982 

"Diagnostic Efficacy - Lung Imaging as a Model. The Society of 
Nuclear Medicine Efficacy Study" , 29th Annual Meeting of the 
Society of Nuclear Medicine, Miami Beach, Florida, June 15-18, 
1982 

Guest Lecturer, A Symposium; Health Aspects of Nuclear Power 
Plant Incidents , "Regional Organization of Medical Care", 
sponsored by the New York Academy of Medicine and the New York 
State Department of Health, New York, New York, April 7-8, 1983 

Guest Lecturer, 23rd Annual Symposium on Trauma , "Irradiation 
Trauma", sponsored by the Michigan Committee on Trauma, The 
American College of Surgeons, Lakeshore Continuing Medical 
Education, Inc. and Muskegon County Medical Foundation, Muskegon, 
Michigan, September 21, 1983 

Guest Lecturer, International Conference on Nucler.r Medicine , 
"Efficacy Analysis in Nuclear Medicine - Lung Scanning as a 
Model" and "Potentials for TC-99m Myocardial Imaging Agents", 
Rhodes, Greece, April 24-29, 1984 

Guest Lecturer, Medical/Legal Aspects of Radiation Induced 
Cancer , "Impact of Compensation Legislation on Medical Sciences", 
sponsored by the Radiation Management Corporation, Philadelphia, 
Pennsylvania, September 5-7, 1984 

Guest Lecturer, "Probability of Causation", sponsored by Electric 
Boat Company, Groton, Connecticut,- May 14, 1985 

Guest Lecturer, "Determination of Clinical Efficacy: Nuclear 
Medicine as Applied to Lung Scanning" , sponsored by University of 
Connecticut, Farraington, Connecticut, May 15, 1985 

Guest. Lecturer, Medical Aspects of Radiation Emergencies , "New 
Trends in Triage and Treatment of the Accident Victim" , sponsored 
by Yale University School of Medicine, Lawrence & Memorial 
Hospitals, New London, Connecticut, May 16, 1985 

Guest Lecturer, Emergency Planning and Response , "Case Studies ot 
Radiation Accidents" and "Legal Implications: Long Term Risk and 
Compensation", Health Physics Summer School, Evanston, Illinois, 
June 3-7, 1985 



196 



10 



Guest Lecturer, 1985 International Congress of Radiology, 
"Efficacy and Cost Effectiveness of Diagnostic Tests: Lung Scans 
for Pulmonary Embolism" , "Medical-Legal Problems for the 
Radiologist as a Consultant" ; also served as co-moderator of 
session entitled "Decision Making and Image Selection", Honolulu, 
Hawaii, July 8-12, 1985 

Guest Lecturer, Advanced Management of Radiation Accidents , 
"Early Medical Decisions", and "Legal Aspects-A Physician's View" 
sponsored by the University of New Mexico School of Medicine, 
Albuquerque, New Mexico, October 3-5, 1985 

Guest Lecturer, Toxicology; Basic Science and Clinical Research , 
"New Thoughts About Radiation Accidents", sponsored by the 
University Association for Emergency Medicine and the 
International Research Institute for Emergency Medicine, San 
Francisco, California, February 13-14, 1986 

Guest Lecturer, "Should There Be a Limit of Patient Exposure 
Based on Risk?", sponsored by Brookhaven National Laboratory, 
Upton, L.I., New York, April'?, 1986 

Guest Lecturer, "Nuclear Accident Management", Society of Nuclear 
Medicine Annual Meeting refresher course, presented in June of 
1986, 1987 and 1988 

Guest Lecturer, "Acute Effects of Radiation", International 
Conference on Non-Military Radiation Emergencies, sponsored by 
the American Medical Association, Washington, D.C., November 
19-21, 1986 

Recipient of the 28th George Charles de Hevesy Nuclear Pioneer 
Award, presented at the 34th Annual Meeting of the Society of 
Nuclear Medicine, Toronto, Ontario, Canada, June 2, 1987 

Co-chair, Special Session; Chernobyl , "Diagnosis and Treatment of 
Acute Radiation Injury", presented at the Health Physics Society 
Annual Meeting, Salt Lake City, UT, July 5-10, 1987 

Keynote address. Physician's Role in Nuclear Mass Casualties; 
Applications of the Chernobyl Experience , "The Physician's Role 
in Nuclear Energy", sponsored by the Department of Radiation 
Therapy, Hospital of the University of Pennsylvania and Radiation 
Management Consultants, Cincinnati, OH, September 11-13, 1987 

Guest Lecturer, "Benefit, Risk and Cost-Effectiveness in Medical 
Radiation", sponsored by the U.S. Food and Drug Administration, 
Center for Drug Evaluation and Research, Rockville, MD, October 
28, 1987 

Recipient of the Daniel Drake Award, the most prestigious award 
given by the University of Cincinnati College of Medicine for 
outstanding contributions to medicine and science, June 1988 



197 



11 



Amy Bowles Lawrence Distinguished Scientist in Research Medicine, 
at the Donner Laboratory and the Lawrence Berkeley Laboratory of 
the University of California, Berkeley, CA, June 13-15, 1988 (Dr. 
Saenger was the inaugural Lawrence Lecturer) 

Clarence C. Lushbaugh Lecture on Controversial Radiation 
Concepts, "The NIMBY Syndrome", at the Oak Ridge Associated 
Universities, Oak Ridge, TN, October 21, 1988 (Dr. Saenger was 
the inaugural Lushbaugh Lecturer) 

Guest Lecturer, Topics in Radiological Health for Physicians , 
"Medical Management of Irradiated Patients", sponsored by the 
Medical College of Ohio, Toledo, OH, January 19-20, 1990 

Guest Lecturer, "Is the Environment Around DOE Plants as 
Hazardous as Represented?", sponsored by the Eastern Chapter, 
Health Physics Society, Oak Ridge, TN, March 20, 1990 

Guest Lecturer, Occupational Health dn Nuclear Facilities , 
"Counseling the Radiation Worker and Family" , sponsored by 
REAC/TS, Oak Ridge Associated Universities, Oak Ridge, TN, August 
17, 1990 

Guest Lecturer, Clinical Approaches to Medicine in the Nuclear 
Industry , "Medical Management of the Irradiated Patient", 
sponsored by Radiation Management Consultants, held in Orlando, 
FL, October 11, 1990 

Guest Lecturer, 26th Radiology Congress of the German Democratic 
Republic, "Acute Local Radiation Injury", "Diagnosis and 
Treatment of the Acute Radiation Syndrome" and "Late Effects from 
Radiation", Heringsdorf, East Germany, October 23-24, 1990 

Guest Lecturer, Soviet Refugee Health and Mental Health: Twenty 
Years of Soviet Resettlement , "Chernobyl: Fallout Revisited", 
sponsored by the Office of Refugee Health, Office of the 
Assistant Secretary of Health, DHHS , Chicago, IL, December 10-12, 
1991 

Guest Lecturer, Radiation Protection in Medicine , "Implications 
of the New Risk Estimates". Annual meeting of the National 
Council on Radiation Protection and Measurements, Arlington, 
VA, April 1-2, 1992 

"Medico Legal Issues Associated with Ionizing Radiation", 
presented at the annual meeting of the American Roentgen Ray 
Society, San Francisco, California, April 25-30, 1993 

Recipient of the 1993 Gold Medal of the Radiological Society of 
North American (RSNA), the highest honor of the Society, presented 
at the RSNA Annual Meeting, Chicago, Illinois, November 30, 1993 



198 



12 



Professional Societies; -^ 

Academy of Medicine of Hamilton County 

Alpha Omega Alpha 

American Association for the Advancement of Science 

American College of Nuclear Physicians 

American College of Radiology 

American Medical Association 

American Radium Society 

American Roentgen Ray Society 

Cincinnati Radiation Society 

Greater Cincinnati Radiological Society 

Health Physics Society 

Ohio State Medical Association 

Ohio State Radiological Society 

Radiation Research Society 

Radiological Society of North America 

Sigma Xi 

Society for Medical Decision Making 

Society of Nuclear Medicine 

Society of Pediatric Radiology 



199 



13 



Publications 



1947 



Unilateral Paraspinal Abscess, Radiology 48: 256-259, March 
1949 

Pyarthrosis in Infancy, Ohio State Medical Journal 45: 453-458, 
May with J.V. Greenebaum and J. A. Frieberg 

1950 

Spondylarthritis in Children, American Journal of Roentgen., Rad, 
Therapy and Nuclear Medicine , LXIV: 20-31, July 

1952 

Results of Therapy with Radioactive Iodine-131 in 
Hyperthyroidism, Ohio State Medical Journal 50: 26-27, January, 
with R.E. Goldsmith 

Letterer-Siwe' s Disease: Problems in Diagnosis and Treatments, 
American Journal Roentgen., Rad. Therapy and Nuclear Medicine , 
LXII, No. 3, March, with R.J. Johansraann 

Protection Against Radiations from Radium, Cobalt-60 and 
Cesium-137, National Bureau of Standards Handbook 54 , Section 9: 
Accidents entailing radiation hazards, September 

Emergency Measures and Precautions in Radium Accidents, Journal 
of the American Medical Association 149: 813-815, with R.G. 
Gallaghar, D.S. Anthony and P.J. Valaer 

1955 

Roentgen Ray Epilation under Anesthesia, A.M. A. Archives of 
Dermatology 71: 116, January 

1956 

Carcinoma of the Prostate: Therapy with Radioactive Colloidal 
Gold, U.S. Armed Forces Medical Journal , VII: 469, April, with 
P.D. Beach and D.V. Becker 

A Method for Monitoring Background by Means of Statistical 
Control Chart, American Journal of Roentgen., Rad. Therapy and 
Nuclear Medicine , LXXV: June, with CM. Herbert 

A Method for Labeling the Lone Star Tick with Radioactive 
Indicator (P-32) , Journal of Economic Entomology 49: 393, June, 
with S.E. Knapp, C.J. Farinacci and CM. Herbert 



200 



14 



Radiation Hazards in the Practice of Surgery, The American 
Surgeon 22: 676, with CM. Barrett 

1957 

Radium Capsules and their Associated Hazards, American Journal of 
Roentgen., Rad. Therapy and Nuclear Medicine 77: 511-523, March, 
with R.G. Gallaghar 

1959 

Planning for a Radiation Accident, American Industrial Hygiene 
Association Journal 20: No. 6, December 

1960 

Incidence of Neoplasia Following Therapeutic Irradiation for 
Benign Conditions in Children, Radiology 74: 885-902, June, No. 6 

Radiation Accidents, American Journal Roentgenology, Radiation 
Therapy and Nuclear Medicine 84: 715-728, October 

1962 

Radiation Epidemiology, Cancer 15: 4C9-503, May-June, No. 3 

1963 

Medical Aspects of Radiation Accidents; A Handbook for 
Physicians, Health Physicists and Industrial Hygionists , 
published by the U.S. Government Printing Office, February 

Hospital Planning to Combat Radioactive Contamination, Journal of 
the American Medical Association 185: 570-581, August 17 

Deoxycytidine in Urine of Humans After Whole-Body Irradiation, 
Science 142: 396-398, October 18, No. 3590, withH.K. Berry, H. 
Perry, B.I. Friedman, J.G. Kereiakes and C. Scheel 

Robot Data Screening: Proceedings of the Conference on Data 
Acquisition and Processing in Biology and Medicine, Pergamon 
Press, with T.D. Sterling and M. Gleser 

Robot Treatment Planning: Proceedings of the Conference on Data 
Acquisition and Processing in Biology and Medicine, Pergamon 
Press, v/ith T.D. Sterling, H. Perry and J. VZeinkam 

Some Plain Facts About Computer-Oriented Programs in Medical 
Centers, Proceedings of the Conference on Data Acquisition and 
Processing in Biology and Medicine, Pergcunon Press 

Liver Scanning in the Diagnosis of Hematobilia, Radiology 81: 
980-983 



201 



15 



Carcinogenic Effects of Iodine-131 compared with X-Irradiation - 
A Review, Health Physics 9: 1371, with R. Seltzer, T.D. Sterling 
and J.G. Kereiakes 

Liquid Scintillation Counting of 1-131 in a Clinical Laboratory, 
Journal of Nuclear Medicine 4: 426-438, with H. Horwitz, J.G. 
Kereiakes and T. Selkirk, Jr. 

1964 

Radiation Casualties: Newer Aspects of Mass Casualty Care, New 
York State Journal of Medicine 64; No. 2, with M.L. Boone 

Radiation Therapy: Chapter 79, pp 684-796, Pediatric Therapy , 
editor: Harry C. Shirkey, published by C.V. Mosby, with J. P. 
Dorst 

Radiation Exposure from Radioiodine Compounds in Pediatrics, 
Radiology 82: 486-494, with R.A. Seltzer, J.G. Kereiakes, and 
D.H. Myers 

Radiation Exposure from Radioisotopes in Pediatrics, New England 
Journal of Medicine 271: 84-90, with R.A. Seltzer and J.G. 
Kereiakes 

Endoreduplication in Leucocyte Chromosomes - Preliminary Report 
of Its Relation to Cancer and VJhole Body Irradiation, The Lancet , 
September 5, pp 494-495, with B.I. Friedman and M.S. Kreindler 

Epidemiology and the Practicing Physician, Cincinnati Journal of 
Medicine 45: 397-398 

Experiences with 1-131 in the Management of Carcinoma of the 
Thyroid, Radiology 83: 892, with CM. Barrett, J.W. Passino, R.A. 
Seltzer and W.D. Dooley 

Implications to Man of Irradiation by Internally Deposited 
Strontium-89, Strontium-90 and Cesium-137. A Report of the 
Advisory Committee to the Federal Radiation Council, December 31, 
1964. Division of Medical Sciences, National Academy of Sciences 
- National Research Council, Washington, D.C. 

1965 

Continuing Use of the Whole Body Counter - The Nature of the 
Problems, reprinted from Radioactivity in Man , editor: G.R. 
Meneely, pp 450-461, published by Charles C. Thomas, with J.G. 
Kereiakes 

Do Malignancies Result from Diagnostic and Therapeutic Radiation, 
from Genetics and the Epidemiology of Chronic Diseases, Part IV, 
pp 355-371, Public Health Service' Publication No. 1163 , U.S. 
Government Printing Office, Superintendent of Documents, 
Washington, D.C, with T. Sterling and R.A. Seltzer 



202 



16 



Radionuclide Doses to Infants and Children: A Plea For a Standard 
Child, Health Physics 11: 999-1004, with R.A. Seltzer, J.G. 
Kereiakes and B. Blackburn 

Treating the Radiation Casualty, Sununary of Proceedings 16th 
National Conference on Disaster Medical Care , October 30-31, 1965 

1966 

Specific Proteins in Serum of Total-Body Irradiated Humans, The 
Journal of Immunology 96: 64-67, with B.I. Friedman, A.J. Luzzio 
and J.G. Kereiakes 

Hematological and Dosimetric Findings in Human Beings Receiving 
VJhole and Half Body Radiation, abstracted in Radiation Research 
27: 530, with J.G. Kereiakes, B.I. Friedman and H. Perry 

1967 

A Sensitive Technique for Measuring Thyroidal Uptake of 1-131 
Iodine, Journal of Nuclear Medicine 8: 86-96, with H.N. Wellman, 
J.G. Kereiakes, T.B. Yeager and C.J. Karches 

Treatment of Acute Radiation Injury under Medically Austere 
Conditions, prepared by TRIMAC Committee (E.L. Saenger member of 
Coitimittee) at the request of the Office of Civil Defense, 
Department of Defense and the National Radiological Defense 
Laboratory, San Francisco, California, OCD Subtask 2431F, April 

Effects of Total and Partial Body Therapeutic Irradiation in Man: 
Proceedings of the 1st International S^Taposium on the Biological 
Interpretation of Dose from Accelerator-Produced Radiation: U.S. 
Atomic Energy Commission, Division of Technical Information, 
CONF-670305 

The Role of the Citizen in Health Planning, Cincinnati Journal of 
Medicine page 62, (first in a three-part presentation given by 
E.L. Saenger, M.D., President of the Public Health Federation, as 
the keynote address at the Golden Centennial Celebration of the 
Public Health Federation and Cincinnati Health Department, 
November 16, 1967) 

New Needs and Trends in Nuclear Medicine (keynote address) , 
presented at the symposium, Reduction of Radiation Exposure in 
Nuclear Medicine, held at Michigan State University, East 
Lansing, Michigan, August 7-9, published in Environmental Health 
Series , Radiological Health, U.S. Department of Health, Education 
and Welfare, PHS, Publication #999-RH-30 

1968 

Colorimetric Analysis of Deoxycytidine in Urine after Separation 
by Ion-Exchange Column Chromatography, Journal of Analytical 
Biochemistry 23: 230, with I.W. Chen, J.G. Kereiakes and B.I. 
Friedman 



203 



17 



Radiopharmaceutical Dosimetry in Pediatrics, Radiology 90: 
925-930, with J.G. Kereiakes, H.N. Wellman and J. Tieman 

Clinical Experience with Oblique Viev/s in Pulmonary Perfusion 
Scintiphotography in Normal and Pathological Anatomy, Journal of 
Nuclear Medicine 9: 374, with H.N. Wellman, J.F. Mack and B.I. 
Friedman 

Studies of Preliminary Experience with the Use. of Iodine-123 for 
Thyroid Function and Scanning Compared to Iodine-131, Journal of 
Nuclear Medicine 9: 359 

A New Concept in Dynamic-Function Studies - Quantitative 
Cinescintivideography , Journal of Nuclear Medicine 9: 420, with 
H.N. Wellman, J.G. Kereiakes and D. Hunkar 

The Use of Computers in Nuclear Medicine: Proceedings of 
Conference on the Use of Computers in Radiology, held October 
20-23, published April 1968, University of Missouri 

Incidence of Leukemia Following Treatment of Hyperthyroidism, 
JAMA 205: 147-154, with G.E. Thoma and E.A. Tompkins (A 
cooperative study) 

Radiation Exposure of Uranium Miners. A Report of the Advisory 
Committee to the Federal Radiation Council, National Academy of 
Sciences, Washington, D.C., August 27, 1968 

Radiation-Induced Urinary Excretion of Deoxycytidine by Rats and 
Humans, Radiology 91: 345-348, with I.W. Chen, J.G. Kereiakes and 
B.I. Friedman 

Status of Research in Diagnostic Radiology. A Report by the 
Radiology Training Committee of the National Institute of General 
Medical Sciences, National Institutes of Health, (E.L. Saenger, 
Member of Committee) , Bethesda, Maryland, 1968 

Management of the Early Phase of Radioactive Contamination in 
Human Beings: reprinted from Diagnosis and Treatment of Deposited 
Radionuclides , Proceedings of a Sionposium held at Richland, 
Washington, May 15-17, Excerpta Medica Foundation pp 600-607 

1969 

Radiologists, Medical Radiation and the Public Health, Annual 
Oration presented at the Radiological Society of North America, 
Chicago, Illinois, December 4, published in Radiology (special 
edition) 92: 681-699, March 

Medulloblastoma - A Review of Prognosis and Survival, British 
Journal of Radiology 42: 198-214, with D.R. McFarland, H. Horwitz 
and G.K Bahr 



204 



18 



Clinical Experience with Oblique Views in Pulmonary Perfusion 
Camera-Imaging in Normal and Pathological Anatomy, Radiology 92: 
897-902, with J.F. Mack, H.N. Wellman and B.I. Friedman 

Total and Half-Body Irradiation: Effect on Cognitive and 
Emotional Processes, Archives of General Psychiatry 21: 574-580, 
with L.A. Gottschalk, R. Kunkel, T.H. Wohl and C.N. Winget 

Patient and Personnel Dose during Radioisotope Procedures. 
Proceedings of a Conference held at Baylor University College of 
Medicine, Houston, Texas, November 21-22 published in Medical 
Radiation Information for Litigation , DMRE 69-3, p 153, July 
1969, with J.G. Kereiakes, H. Horwitz, H.N. Wellman and V.J. Sodd 

1970 

The Future of Radioisotopes in Medicine: Benefits vs Risks, 
published in Medical Radionuclides: Radiation Dose and Effects , 
editors: R.J. Cloutier, C.L. Edwards, W.S. Snyder. U.S. Atomic 
Energy Commission, Division of Technical Information, pp 491-507, 
June 1970, proceedings of a SiTtiposium held at the Oak Ridge 
Associated Universities, December 8-11, 1969 

National Uses and Needs for Standard Radioactive Materials. A 
Report by an Ad Hoc Panel of the Committee on Nuclear Science, 
National Research Council, National Academy of Sciences, 
Washington, D.C., 1970, E.L. Saenger, Member of Panel 

1971 

Radiation and Leukemia Rates, letter to Science 171: 1096-1C98, 
No. 3976, March 19, \;ith E, Tompkins and G.E. Thoma 

Cytologic-Biochemical Radiation Dosimeters in Man, Biochemical 
Indicators of Radiation Injury in -Man , International Atomic 
Energy Agency, Vienna, (PL-409/13) , pp 181-214, with E.B. 
Silberstein, I.W. Chen and J.G, Kereiakes 

Estimate of Manpower Needs of Medical Physicists in the United 
States, American Association of Physicists in Medicine 5 (2): 
129-131, with L.H. Lanzl and J.G. Kereiakes 

A Head-Holding Device for Improved Brain Scintigraphy, Journal of 
Nuclear Medicine 12: 305-306, June, with R.A. Berke 

Caie of Patients Involved in Radiation Accidents: Recent 
Advances. Der Strahlenunfall und seine Behandlung, vom. 19-20, 
Juni 1970 in Zurich, published by George Thieme Verlag, 
Stuttgart, pp 54-78 



205 



19 



The Safe Tracer Dose in Medical Investigation, reprinted from 
Progress in Atomic Medicine; Recent Advances in Nuclear Medicine , 
Chapter 5, Vol. 3, pp 139-165, editor, John H. Lawrence, by Grune 
and Stratton, Inc., with J.G. Kereiakes 

1972 

Protection Against Radiation from Brachytherapy Sources, NCRP 
Report No. 40 (National Council on Radiation Protection and 
Measurements), March 1972. E.L. Saenger, M.D., Chairman of 
Committee preparing report 

Active Bone-Marrow Dose Related to Hematological Changes in 
Whole-Body and Partial-Body Co Gamma Radiation Exposures, 
Radiology 103: 651-656, with J.G. Kereiakes, W. Van de Tiet, C. 
Born, E.B. Silberstein, and C. Ewing 

Human Skeletal Scanning with a Stable 'Vechnetium-Tin-Phosphate 
Agent, Southern Medical Journal 65: 1407, with E.B. Silberstein, 
H. Park and G.W. Alexander 

A Study of the Parameters Influencing the Clinical Use of 
Iodine-123, Angiography/ Scintigraphy - Symposium of the European 
Association of Radiology, Editor L. Diethelm, Springer-Verlag, 
Berlin, pp 129-137, with H.N. Wellman, J.F. Mack, R.E. Goldsmith 
and V.J. Sodd 

Radiopharmaceutical Dosimetry in Pediatrics, Seminars in Nuclear 
Medicine 2: (no. 4 - October), 316-327, with J.G. Kereiakes, H.N. 
Wellman and G. Simmons 

The Effects on Populations of Exposure to Low Levels of Ionizing 
Radiation (BEIR Report) , National Academy of Sciences, National 
Research Council, Washington, D.C., November, E.L. Saenger, 
Member of Committee 

A Fixed Format Lexicon for Nuclear Medicine Reports, DHEW Pub. 
No. (FDA) 74-8009, with R.G. Hoops, V.J. Sodd, G.W. Alexander 

1973 

A Multiple-Dose ^"^^Xe Solution "Generator": The Disposable Glass 
Ampule Equilibration Chamber, Journal of Nuclear Medicine 14, 
with R.G. Carroll, R.A. Berke, R.T. Anger, G. Levine, and H.N. 
Wellman 

Radiation Dose to Breast-Feeding Child after Mother has ^c-MAA 
Lung Scan, Journal of Nuclear Medicine 14: 51-52, with R.A. 
Berke, R.C. Hoops and J.G. Kereiakes 



206 



20 



Pediatric Radiopharmaceutical Dosimetry, Proceedings of the XIII 
(13th) International Congress of Radiology, p. 238, Madrid, 
October 15-20, with J.G. Kereiakes and V.J. Sodd 

Whole and Partial Body Radiotherapy of Advanced Cancer, American 
Journal Roentgenology, Radiation Therapy and Nuclear Medicine 
117: (3) 670-685, Presented at the 73rd Annual Meeting of the 
American Roentgen Ray Society, Washington, D.C., October 3-6, 
1972, with E.B. Silberstein, B. Aron, H. Horwitz, J.G. Kereiakes, 
G-K. Bahr, H. Perry and B.I. Friedman 

Radiation-Induced Change in Serum and Urinary Amylase Levels in 
Man, Radiation Research 54: 141-151, April, with I.W. Chen, J.G. 
Kereiakes, B.S. Aron and E.B. Silberstein 

Clinical Evaluation of Radioimmunoassay of Digoxin, Journal of 
Nuclear Medicine 14: (7) 531-533, July", with H.M. Park, I.VJ. 
Chen, A. Lowery and G.T. Manitasas 

Radiation Dose to Various Organ Sites in a Tissue-Equivalent 
Humag^Phantom Resulting from Implantation of a Promethium 147 
(Pm ) Intracardiac Nuclear Pacemaker, American Journal of 
Roentgenology, Radiation Therapy and Nuclear Medicine 118: (4) 
768-776, August, v/ith W. Arnold, J.G. Kereiakes, G.K. Bahr and 
J.W. Spickler 

Prospects for Dose Reduction and Assessment in Nuclear Medicine, 
presented at Second International Symposium on Nuclear Medicine, 
Carlsbad, NM, with H.N. Wellman, V.J. Sodd, J. Robbins, B.M. 
Branson and J.G. Kereiakes 

1974 

Scintiscanning with Gallium Citrate 67, Diagnosis of Head and 
Neck Malignant Neoplasms, Archives of Otolaryngology 100: 
201-206, September, with A.D. Kornblut, E.B. Silberstein and D.A. 
Shumrick 

A Comparison of I and I for Thyroid Imaging Using Various 
Collimators, International Journal of Nuclear Medicine and 
Biology 1: 201-204, with H. Nishiyama, A.B. Ashare, A. Shafie and 
V.J. Sodd 

14 

C-Tripalmitin Breath Test as a Diagnostic Aid for Fat 

Malabsorption due to Pancreatic Insufficiency, Journal of Nuclear 
Medicine 15 (12): 1125-1129, with I.W. Chen, A. Kambiz and A.M. 
Connell 

Efficacy Studies in Nuclear Medicine, reprinted from Proceedings 
of the XIII International Congress of Radiology , Excerpta Medica 
1: 45-48, Amsterdam 

123 131 
Evaluation of Clinical Value of I and I in Thyroid Disease, 

Journal of Nuclear Medicine 15: 261, with H. Nishiyama, V.J. 

Sodd, and R.A. Berke 



207 



21 



Quantification of Myocardial Infarction by Scintigraphy: An 
Autopsy Correlated Study, Journal of Nuclear Medicine 15: 475, 
(abstract) with A.B. Ashare, D.W. Romhilt, V.J. Sodd, N.I. 
Levinson, R.J. Adolph, and L.S. August 

1 TO 

Detection and Evaluation of Pulmonary Malignancies Using " Cs, 
Recent Advances in Nuclear Medicine, Proceedings of the First 
World Congress of Nuclear Medicine, Ohkawa Printing Company, 
Yokohama, p. 255, Tokyo, September, with H. Nishiyama and V.J. 
Sodd 

An Investigation of the Disposal of Radiopharmaceuticals in the 
Cincinnati Sewage System, Recent Advances in Nuclear Medicine, 
Proceedings of the First World Congress of Nuclear Medicine, 
Ohkawa Printing Company, Yokohcima, p. 298, Tokyo, September, with 
V.J. Sodd and R.J. Velten 

1975 

Some Possible Consequences of Recertification, Radiology 114: 
745-746, March 

The Use of Nuclear Medicine in Evaluating Liver Disease, Seminars 
in Roentgenology 10: (3) 215-222, July, v/ith L.E. Holder 

Q9in_ 125 
Concentrations of Medically Useful Radionuclides (' Tc, I and 

I) at a Large Metropolitan Waste Water Treatment Plant, Health 

Physics 28: 355-359, with V.J. Sodd and R. Velten 

Evaluation of Radiochemical Protectors Using Urinary 
Deoxycytidine Levels, International Journal of Radiation Biology 
28: (2) 117-124, with D.E. Wrede, I,W. Chen and J.G. Kereiakes 

The Gamut Approach to Scintigram Interpretation - Diagnostic and 
Teaching Method, Journal of Nuclear Medicine 16: (12), December, 
with L.E. Holder, A.B. Ashare, T. Tomsick, D.P. Colley, M. 
Fernandez-Ulloa, and Z. Catz 

Reactor Safety Study (WASH-1400) , An Assessment of Accident Risks 
in U.S. Commercial Nuclear Power Plants, Appendix VI, United 
States Nuclear Regulatory Commission, October, E.L. Saenger, 
Member of Advisory Group on Health Effects 

Interpretation of Radionuclide Liver Images: Do Training and 
Experience Make a Difference?, Journal of Nuclear Medicine 16, 
with H. Nishiyama, J.T- Lewis, and A.B. Ashare 

Intercomparison of Myocardial Imaging Agents, Journal of Nuclear 
Medicine 16: 553, with H. Nishiyama, V.J. Sodd, J.T. Lewis and 
R.J. Adolph 

Inadequacies of Gamma Camera Performance and Quality Control, 
Journal of Nuclear Medicine 16: 564 (abstract), with V.J. Sodd, 
J.G. Kereiakes and R.J. Van Tuinen 



208 



22 



127 
Clinical Experience with Xe, Continuing Education Lectures, 

Proceedings of the 16th Annual Meeting of the Southeastern 

Chapter of the Society of Nuclear Medicine, page 6, (abstract), 

with H. Nishiyama, V.J. Sodd, J.T. Lewis and U.A. Neff 

1''9 -1 

Imaging of Pulmonary Tumors with " Cs. Radiopharmaceuticals , 

Subramanian, et al. , editors. Society of Nuclear Medicine, New 

York, p. 125, with H. Nishiyama, V.J. Sodd, T.J. Schreiber and 

R.G. Loudon 

1976 

Cystourethrography Procedures in Children: Evaluation of 
Benefits versus Dose, Radiology 118: 123-128, with J.G. 
Kereiakes, D.J. Cavanaugh, J.L. Hall and W. Eiseman 

Breast Cancer Screening - Benefit and Risk for the First Annual 
Screening, Radiology 120: 431-432, with M. Moskowitz, J.G. 
Kereiakes, S. Pemmaraju, A. Kumar and G. Tafel 

The Use of Radioactive Cesium Chloride for Imaging of Malignant 
and Benign Pulmonary Lesions, Surgery, Gynecology and Obstetrics 
143: 575-580, with H. Nishiyama, J.T. Lewis and R.C. Hoops 

Imaging of Pulmonary Tumors with ""■ Cs, Radiopharmaceuticals , pp 

482-490, with H. Nishiyama, V.J. Sodd, T.J. Schreiber and R.G. 

Loudon 

201 129 43 
Interccmparison of Myocardial Imaging Agents: Tl, Cs, K 

and Rb, Journal of Nuclear Medicine 17: 880-889, with H. 

Nishiyama, V.J. Sodd, R.J, Adolph, J.T. Lewis and H. Gabel 

Lack of Specificity for Detection of Breast Lesions with 
Radioactive Cesium' Chloride , Surgery, Gynecology and Obstetrics 
143, with H. Nishiyama, M. Moskowitz, J.T. Lewis, and R.G. Hoops 

Radiation Contamination and Acute Radiation Injury, in Initial 
Management of the Trauma Patient , editor Charles Frey, published 
by Lee and Febiger, Philadelphia, pp 203-228 

Radiobiology and Dosimetry of Pediatric Nuclear Medicine, in The 
Pediatric Nuclear Medicine Club: A Bibliography of Pediatric 
Nuclear Medicine Literature , Searle Radiographics, Inc., pp 
1601-1659, with M.J. Gelfand 

Cesium-137 Body Burdens and Half-Life in a Group of Adult Males 
in Cincinnati,' Ohio, Health Physics 30, with J.T. Lewis, L.W. 
Grossman, and J.G. Kereiakes 

NUMEDACON: Nuclear Medicine Report and Data Storage System, 

Proceedings 6th Symposium on Sharing of Computer Programs and 

Technology in Nuclear Medicine, p. 118, with R.G. Hoops, M.L. 
Yudofsky, A.B. Ashare and V.J. Sodd 



209 



23 



Radiopharmaceutical Dosimetry in Pediatrics, Proceedings of the 
62nd Scientific Assembly and Annual Meeting of the Radiological 
Society of North America (RSNA) , with J.G. Kereiakes, S.R. 
Thomas, F.A. Ascoli, M,J. Gelfand, P. A. 
Paras, J.W. Poston, G.G. Warner and R.L. 



Feller, V.J. 
Shoup 



Sodd, P. 



1977 



Quantitative External Counting Techniques Enabling Improved 
Diagnostic and Therapeutic Decisions in Patients with 
Well-Differentiated Thyroid Cancer, Radiology 122: 731-737, with 
S.R. Thomas, H.R. Maxon and J.G. Kereiakes 

"The Developing Role of Short-Lived Radionuclides in Nuclear 
Medicine", A Report of the Task Force on Short-Lived 
Radionuclides for Medical Applications to the Bureau of 
Radiological Health, Food and Drug Administration, U.S. 
Department of Health, Education and Welfare, August. E.L. 
Saenger, Chairman of Committee 

NCRP Report No. 55, "Protection of the Thyroid Gland in the Event 
of Releases of Radioiodine" , Recommendations of the National 
Council on Radiation Protection and Measurements, E.L. Saenger, 
Chairman of Committee 

A Comparison of Technetium Etidronate and Pyrophosphate for Acute 
Myocardial Infarct Imaging, Journal of Nuclear Medicine 18: 
905-909, with C. Williams, H. Nishiyama, R. Adolph, M. Gabel, D. 
Romhilt and V.J. Sodd 

Radiation-Associated Thyroid Carcinoma , editor Leslie J. DeGroot, 
M.D., E.L. Saenger contributing editor, Grune and Stratton, New 
York, 1977 

Ionizing Irradiation and the Induction of Clinically Significant 
Disease in the Human Thyroid Gland, The American Journal of 
Medicine 63: 967-978, with H.R. Maxon, S.R. Thomas, C.R. Buncher 
and J.G. Kereiakes 

^^se to the Metaphyseal Growth Complexes in Children Undergoing 
^c-EHDP Bone Scans, Radiology 126: 193-196, with S.R. Thomas, 
M.J. Gelfand, J.G. Kereiakes, F.A. Ascoli, H.R. Maxon, P. A. 
Feller, V.J. Sodd and P. Paras 

1978 



Radiation Induced Thyroid Cancer, Cincinnati Journal of Medicine 
3: 59, March 

Benefit/Risk Analysis of Aggressive Mammographic Screening, 
Radiology 128: 359-365, with S.H. Fox, M. Moskowitz, J.G. 
Kereiakes, J. Milbrath and M.W. Goodman 



210 



24 



Evaluation of Diseases of the Thyroid Gland v/ith the In-Vivo Use 
of Radionuclides, Journal of Nuclear Medicine 19: 107-112, v;ith 
Task Force on Short-Lived Radionuclides, Bureau of Radiological 
Health, Food and Drug Administration, U.S. Department of Health, 
Education and Welfare 

Sarcoma Dotyroides of the Vagina in Childhood, Treated by 
Irradiation and Vaginal Reconstruction, American Journal of 
Obstetrics and Gynecology 132: 339-340, October, with R.D. 
Patchell 

Diagnostic Radiation for a Young Woman, JAMA 240: 1641, October, 
with J.G. Kereiakes 

1979 

Radiotherapeutic Agents: Properties, Dosimetry, and P.adiobiologic 
Considerations, Seminars in Nuclear Medicine 9: (2) 72-84, with 
J.G. Kereiakes, V.J. Sodd and R. David 

Medical Radiation Exposure During Pregnancy, JAMA 242: 1669, 
October, with J.G. Kereiakes 

1980 

Radiation Effects and Radiation Protection, in Nuclear Medicine 
Reviev/ Syllabus , editor Peter T. Kirchner, M.D., Society of 
Nuclear l-ledicine Inc., 475 Park Avenue South, New York, NY 10016, 
with R.T. Anger, A.R. Benedetto and R.L. Witcofski 

Clinical Experiences in C-tripalmitin Breath ToEt fcr Fat 
Malabsorption, American Journal of Gastroenterology , pp 227-231, 
March, with H.E. Meeker, I.W. Chen and A.M. Connell 

Clinically Important Radiation-Associated Thyroid Disease - A 
Controlled Study, JAMA 244: 1802-1805, October 17, with H.R. 
Maxon, S.R. Thomas, C.R. Buncher, J.G. Kereiakes, M.L. Shafer and 
C-A. McLaughlin 

Reflections on Cancer Treatment and the Federal Agency 
Regulations, Radiology 137: 865-866, December, with J.G. 
Kereiakes 

Efficacy and Efficiency of the Diagnostic Applications of 
Radiation and Radionuclides, Report of a meeting organized by the 
World Health Organization and the Government of the Federal 
Republic of Germany, Neuherberg, FRG, Dec. 5-7, 1979; proceedings 
published April 1980 

Clinical Course and Dosimetry of Acute Hand Injuries to 
Industrial Radiographers from Multicurie Sealed Gamma Sources, in 
The Medical Basis for Radiation Accident Preparedness , K.F. 
Hubner and S.A. Fry, eds . , Elsevier North Holland, Inc., 1980, 
with J.G. Kereiakes, N. Wald and G.E. Thoma 



211 



25 



Biological Risks of Medical Irradiations , edited by G.D. 
Fullerton, D.T. Knopp, R.G. Waggener, E.W. Webster. E.L. Saenger 
contributing author: "Methods of Risk Reduction in Nuclear 
Medicine" v/ith J.G. Kereiakes and S.R. Thomas; "Dose Evaluation 
in Nuclear Medicine" with J.G. Kereiakes, S.R. Thomas, M.J. 
Gelfand and H.R. Maxon. American Association of Physicists in 
Medicine, Medical Physics Monograph #5 

Survey of Technetium-99m Contamination of Laboratory Personnel: 
Its Degree and Routes, Radiology 135: 467-471, with H. Nishiyama 

1981 

Radiation-Associated Carcinoma of the Salivary Glands: A 
Controlled Study, Annals of Otolaryngology 90: 107-108, with H.R. 
Maxon, S.R. Thomas, M.L. Shafer, C.R. Buncher, J.G. Kereiakes and 
C.A. McLaughlin 

Once to Every Man. . .An Introduction, Medical Decision Making 1: 
(1) page 1 

Evaluation of LAD Blockage: Hazard of Repeated Radiation 
Exposure, JAMA 246: 2754, December 

1982 

"Ethics, Trade-offs and Medical Radiation", Lauriston S. Taylor 
Lecture Series in Radiation Protection and Measurements, Lecture 
No. 6. NCRP Publications, 7910 Woodmont Avenue, Suite 1016, 
Bethesda, MD 20814 

Protection of the Patient in Diagnostic Radiology , ICRP 
Publication 34. E.L. Saenger, Chairman of Task Group preparing 
report. Annals of the ICRP, Volume 9, No. 2/3. Pergamon Press, 
New York 

Development and Use of a New Tc-99m Myocardial Perfusion Agent - 
DMPE. Proceedings of the Third World Congress of Nuclear Medicine 
and Biology, C. Raynaud, ed. , Pergamon Press Vol. No. 2, Paris, 
France, pp 2255-2260, with V.J. Sodd, E.A. Deutsch, H. Nishiycima, 
R.J. Adolph, L.W. Grossman, K.L. Scholz , K. Libson, D.L. Fortman 
and J.L. Vanderheyden 

Nuclear Orthopedics , "Dosimetry", edited by E.B. Silberstein, 
with J.G. Kereiakes, S.R. Thomas, M.J. Gelfand and C.C. Williams, 
New York, Futura Publishers 

Basal Kinetic Studies of Tc-99m DMPE as a Myocardial Agent in the 
Dog, Journal of Nuclear Medicine 23: 1093-1102, with H. 
Nishiysmia, E.A. Deutsch, R.J. Adolph, V.J. Sodd, K. Libson, M.C. 
Gerson, M. Gabel, S.J. Lukes, J.L. Vanderheyden, D.L. Fortman, 
K.L. Scholz, L.W. Grossman and C.C. Williams 



212 



26 



Tc-99m DMPE as a Resting Myocardial Imaging Agent. Journal of 
Nuclear Medicine 23 (5) : '12" (abstract) , with H. Nishiyama, E.A. 
Deutsch, R.J. Adolph, V.J. Sodd, K. Libson, S.J. Lukes, M. Gabel, 
M.C. Gerson and J.L. Vanderheyden 

1983 

Myocardial Perfusion Imaging with "^c-DHPE in Man. European 
Journal of Nuclear Medicine 8: 371-374, with M.C. Gerson, E.A. 
Deutsch, H. Nishiyama, K.F. Libson, R.J. Adolph, L.W. Grossman, 
V.J. Sodd, D.L. Fortman, J.L. Vanderheyden, and C.C. Williams 

Relation Betv;een Effective Radiation Dose and Outcome of 
Radioiodine Therapy for Thyroid Cancer. New England Journal of 
Medicine 309: 937-941, with H.R. Maxon, S.R. Thomas, V.S. 
Hertzberg, J.G. Kereiakes, I.W. Chen, and M.I. Sperling 

Regional Organization of Medical Care. Bulletin of the New York 
Academy of Medicine 59: 1095-1107 

"Dosimetry of Bone-Seeking Radiopharmaceuticals", in Bone 
Scintigraphy , with J.G. Kereiakes, S.R. Thomas, M.J. Gelfand, 
C.C. VJilliams. E.B. Silberstein, editor, Futura Publishing 
Company, Mt. Kisco, NY 

NCRP Report No. 73, "Protection in Nuclear Medicine and 
Ultrasound Diagnostic Procedures in Children", E.L. Saenger, 
committee member. NCRP Publications, 7910 VJoodmont Avenue, Suite 
1016, Bethesda, MD 20814 

1984 

Low-level Internal Radionuclide Contamination: Use of Gamma 
Camera for Detection. Radiology 150: 235-240, with H. Nishiyama 
and S.J. Lukes 

A Guide to the Hospital Management of Injuries Arising from 
Exposure to or Involving Ionizing Radiation, E.L. Saenger, M.D., 
member CSA Advisory Panel, American Medical Association, Chicago, 
Illinois, January 

Family History of Cancer in a Radiation Technologist. JAMA 251: 
1901-1902, April 13 

"The Nuclear Physician's Role in Planning for and Handling 

Radiation Accidents" in, Nuclear Medicine Annual 1984 , L.M. 

Freeman and H.S. Weissman, eds.. Raven Press, New York, 1984, pp 
1-22 

Myocardial Scintigraphy with ^^"^c-tris-DMPE in Man. European 
Journal of Nuclear Medicine 9:403-407, with H-C. Gerson, E.A. 
Deutsch, K.F. Libson, R.J. Adolph, A.R. Ketring, J.L. 
Vanderheyden, and C.C. v;illiams 



213 



27 



Assigned Share for Radiation as a Cause of Cancer , Review of 
Radioepidemiological Tables Assigning Probabilities of Causation. 
Final Report: Oversight Committee on Radioepidemiologic Tables 
(OCRET) , Board on Radiation Effects Research, Commission on Life 
Sciences, National Research Council. National Academy Press, 
Washington, D.C. E.L. Saenger, M.D., member of OCRET Committee 

1985 

Accidental Cs-137 Contaunination, Radiology 154: 513-517, with 
H.Nishiyama, L.W. Grossman and S.J. Lukes 

NCRP Report No. 80, "Induction of Thyroid Cancer by Ionizing 
Radiation" , Recommendations of the National Council on Radiation 
Protection and Measurements. E.L. Saenger, M.D., Advisor to Task 
Group 

Determination of Clinical Efficacy: Nuclear Medicine as Applied 
to Lung Scanning, Journal of Nuclear Medicine 26: 793-806, with 
C.R. Buncher, B.L. Specker and R.A. McDevitt 

Application of an Information-Theoretic Method for Efficacy 
Assessment, Journal of Nuclear Medicine 26: 807-811, with D.A. 
Gift, W.R. Schonbein and E,J. Potchen 

"Health Effects Model for Nuclear Power Plant Accident 
Consequence Analysis" (NUREG/CR-4214) , J.S. Evans, D.W. Moeller, 
D.W. Cooper, eds., U.S. Government Printing Office, P.O. Box 
37082, Washington, D.C. 20013, July. E.L. Saenger, M.D., Member 
of Advisory Group 

1986 

Cost-Effectiveness of Screening Mammography in Low-Risk Patients, 
JAMA 256: 406-407, July 18, with M. Moskowitz 

The Reactor Accident at Chernobyl: A Nuclear Medicine 
Practitioner's Perspective, Seminars in Nuclear Medicine 14(3): 
224-230, July, with J.G. Kereiakes and S.R. Thomas 

Radiation Accidents, Annals of Emergency Medicine 15: 1061-1066, 
September (Proceedings of the 1986 UAEM/IRIEM Research Symposium 
on Toxicology) 

Comparison of I and ""tc Pertechnetate in Nodular Goiter 
Imaging, Radiologia lugoslavica 20 (suppl.III): 47-49, with S. 
Spaventi, Z. Kusic and D.V. Becker 

1987 

Radiation Exposure, in Current Therapy in Emergency Medicine , M. 
Callciham, ed., B.C. Decker Inc., pp 922-927, with H. Nishiyama 



214 



28 



Efficacy and Cost-Ef fectiveness of I.uiig Scans, in Pulmonary 
Nuclear Medicine , M. Loken, ed. , Appleton and I.ange, pp 133-111, 
v;ith B. Specker 

NCRP Report No. 91, "Recomraer.dations on Limits for Exposure to 
Ionizing Radiation", E.L. Saenger, committee member. HCRP 
Publications, 7910 Woodmont Avenue, Suite 1016, Bethesda, MD 
20814 

Pulmonary Embolism and Lung Scanning: Cost-Effectiveness and 
BenefitrRisk, Journal of ?:uclear Medicine 2C: 1521-1530, with 
B.L. Specker, C.R. Buncher and R.A. McDevitt 

Protection of the Patient in Nuclear Medicine , ICRP Publication 
52. E.L. Saenger, Chairman of Task Group preparing report. 
Annals of the ICRP, Volume 17, No. 4. Pergamon Press, Nev/ York 

Don't Dismiss Liability Potential of Medical Radiation Exposure, 
Diagnostic Imaging 9 (12): 120-125 

NCRP Report No. 93, "Ionising Radiation Exposure of the 
Population of the United States", E.I. . Saenger, committee member. 
NCRP Publications, 7910 V.'oodmont Avenue, Suite 1016, Bethesda, MD 
20814 



1989 



NCRP Report No. 100, "E::posure of the U.S. Population from 
Diagnostic Medical Radiation", E.L. Saenger, con-mi'^tfe Tiember. 
NCRP Publications, 7910 Woodmont Avenue, Suite 1016, Rethnsda, MD 
20814 

"Radiation Accidents", prepared by the American College of 
Radiology Ad Hoc Committee on Radiation Accidents, E.L. Saenger, 
committee member. American College of Radiologv, 1091 Preston 
White Drive, Reston, VA 22091 



1990 

Evaluation of Extent of Injury, in Medical Management of 
Radiation Accidents , F.A. Mettler, Jr., C.A. Kelsey and R.C. 
Ricks, eds., CRC Press, pp 67-78 

"Health Effects Models for Nuclear Pov/er Plant Accident 
Consequence Analysis, Low LET Radiation. Part I: Introduction, 
Integration, and Summary" (NUREG/CR-4214 ; SAND85-7185, Rev.l, 
Part I). J.S. Evans, ed. , U.S. Government Printing Office, P.O. 
Box 37082, Washington, D.C. 20013, January. E.L. Saenger, 
Advisory Committee member 



215 



29 



Comparison of Technetiuin-99m and Iodine-123 Imaging of Thyroid 
Nodules: Correlation with Pathologic Findings, Journal of Nuclear 
Medicine 31: 393-399, with Z. Kusic, D.V. Becker, P. Paras, T. 
Hesseler and S. Spaventi 

Radiation and the NIMBY Syndrome, in The Medical Basis for 
Radiation Accident Preparedness II: Clinical Experience and 
Follow-up Since 1979 , R.C. Ricks and S.A. Fry, eds., Elsevier 
Science Publishing Company, New York 

1991 

Radiation Exposure, in Current Practice of Emergency Medicine , M. 
Callaham, ed. , 2nd edition, B.C. Decker, Philadelphia, with E.B. 
Silberstein 

Perception of Radiation Injury vs. Radiogenic Effect, in The 
Medical Basis for Radiation-Accident Preparedness III; The 
Psychological Perspective , R.C. Ricks, M.E. Berger and F.M. 
O'Hara, eds., Elsevier, New York, with J. Hinnefeld 

1992 

Discitis, in The Spine , R.H. Rothman and F.A. Simeone, Founding 
Editors, 3rd edition, W.B. Saunders Company, with J.L. Stambough 

Thyroid Nodules in the Population Living Around Chernobyl, JAMA 
268 (5): 616-619, with F.A. Mettler Jr, M.R. Williamson, H.D. 
Royal, J.R. Hurley, F. Khafagi, M.C. Sheppard, V. Beral, G. 
Reeves, N. Yokoyama, V. Parshin, E.A. Griaznova, M. Taranenko, V. 
Chesin and A. Cheban 

Administration of Stable Iodide to the Population Around the 
Chernobyl Nuclear Power Plant, Journal of Radiological Protection 
12 (3): 159-165, with F.A. Mettler Jr, H.D. Royal, J.R. Hurley, 
F. Khafagi, M.C. Sheppard, V. Beral, G. Reeves, N. Yokoyama, V. 
Parshin, E.A. Griaznova, M. Taranenko, V. Chesin and A. Cheban 

1993 

Reflections on NCRP Statement No. 7, "The Probability that a 
Particular Malignancy May Have Been Caused by a Specified 
Irradiation", Health Physics 64 (5): 549, invited editorial 

Comments on the NCRP Statement No. 7, "The Probability that a 
Particular Malignancy May Have Been Caused by a Specified 
Irradiation", Radiation Research 134: 396-397, invited editorial 



216 



30 



"Implications of the New Risk Estimates" in Proceedings of the 
28th Annual Meeting of the National Council on Radiation 
Protection and Measurements entitled Radiation Protection in 
Medicine , NCRP Publications, 7910 VJoodmont Avenue, Bethesda MD 
20814 



217 

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I. Before 1970: 



HeuWeln. Arthur C, M. D., 'A Preliminary Report on Continuous Irradiation of the 
Entire Body". Radiology Vol. XVII. No. 6. Pages 1051-1062. June. 1932. 

Jacobs. Melville L.. M. D. & Marasso, Fred J. M. D.. "A Four- Year Experience with 
Total-Body Irradiation". Radiology. Vol. 84. No. 3. Pages 452-456. 463. March 1965. 

Jenkin. R.D.T.. M. B.. Rider. W.D.. M.B., F.F.R.. et al. "Ewing's Sarcoma A Trial of 
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King. Captain E. Richard, M.C.. U. S. Navy. 'Use of Total-Body Radiation in the 
Treatment of Far-Advanced Malignancies", Journal of th e Amarican Medical Assoriatlnn Vol. 
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lAeffler, R. Kenneth. M. D. & Puterbaugh. Myron R., M. D. The Therapeutic Use of 
Fractionated Subtotal Body Irradiation", American Journal of Roan taenolo^iy Radium Tharafyy 
and Nuclear Medicine. Vol. 123, No. 1. Pages 170-178. January, 1975. 

Medinger. Fred G.. M. D. & Craver, Uoyd F. M. D., Total Body Irradiation", American 
Journal of Roentoenoloav. Radium Tharapv and NiiH aar Mfldldnft Vol. 48. No. 5. Pages 651- 
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Millbum. Lowell F.. M. D.. O'Grady. Lois, M. D. et al. "Radical Radiation Therapy and 
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Miner. Lowell S. Fletcher, Gilbert H., et ai "Radiobiologic Observations on Cancer 
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Newcomer, Eari H., "A New Cytoiogical and Histological Fixing Fluid". Science. Vol. 
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Rider. W. D.. & Hasseibaclt. R.. The Symptomatic and Haematological Disturtjance 
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II. 1970 to Present: 

A. Total Body Irradiation 

Armitage, James O., M. D., "Bone Marrow Transplantation', The New En gland Journal of 
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Armitage, James O., M. D. & Gale, Robert Peter, M. D., "Bone Marrow 
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August, Charles S., Serota, Frederic T., et al, "Treatment of Advanced Neuroblastoma 
with Supraiethal Chemotherapy, Radiation, and Allogeneic or Autologus Marrow 
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Byhardt, Roger W., M. D., Cox, James D., M. D., et al. Total Body Irradiation vs. 
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Douer. Dan, M. D., Champlin, Richard E., M. D. et al, "High-Dose Combined-Modality 
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Franzone, P., Scarpati, D., et al, "Chemo-radiotherapy and Autologous Bone Marrow 
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Huys. John V., M. D., Simons. Maria J., M. D. et al. "Total Body Irradiation with 8 MeV 
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Kramer, Simon. M. D., "Fraactionated Total-Body Irradiation", Caocfit. Vol. 37, Pages 
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Livingston, Robert B., M. D.. Schulman, Susan, et al, "Combination Chemotherapy and 
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U>effler. Kenneth R., M. D. Therapeutic Use of Fractionated Total Body and Sutjtotal 
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Marcus. Robert B., Jr., M.D., Graham-Pole, John R.. M. D.. et al, 'High-Risk Ewing's 
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Sflemsward. J., M. D., "Adjuvant Radiotherapy Trials in Breast Cancer, Cancer Vol 
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Vrlesendorp. H. M.. "Prediction of Effects of Therapeutic Total Body Irradiation in 
Man". Radiotheraov and Oncology. Supplement 1, Pages 37-50, 1990. 

Vriesendorp. H. M., Herman, M. G., et al, "Future Analyses of Total Body Irradiation" 
International .loumal of Rafliation Onry^lonv. Biology /t Phycj^^^ , Vol. 20, Pages 635-637 
March. 1991, 

ZaWow, Andrew, M. D., Stal>ile, R. J., et al, "Single High Dose-Large Field Irradiation" 
New JerSf^Y Mmlioinfl Vol. 85, No. 1. Pages 39-42, January 1988. 

B. Partial Body Irradiation 

Aziz. H.. M. D.. Choi. K.. M. D., et al, "Comparison of 32P Therapy and Sequential 
Hemax>dfy Irradiation (HBI) for Bony Metastases as Methods of Whole Body Irradiation" 
Amencan Joiimal of Clinical Onmin,7y ^n^j vol. 9, No. 3. Pages 264-268, 1986. 

Elchhorn. H.-J., Prof. Dr. Med., Huttner, J., Dr. Med., et al. "Preliminary Report on 
•Orje-Time" and High Dose Irradiation of the Upper and Lower Half-Body in Patients with Small 
TTco .*]?. ^^"f®'"' International Journal of Rariiatinn Onftnlnny Rini ogy A Phv>;i^ Vol 9, Pages 
1459-1465. October 1983^ 



Page #3 



220 



Epstein, Lonnie M.. Stewart, Bruce H., et al. "Half and Total Body Radiation for 
Carcinoma of the Prostate", .innrnal of Uroloov. Vol. 122, Pages 330-332. 1974. 

Fitzpatrick, Peter J., M. B.. F.R.C.R.. FRCP. & Rider. Waiter D., M. B., F.R.C.R.. FRCP.. 
'Half Body Barilnthftrapy". internation al .Journal of Radiation Oncology. BiolOQV & Phvsics. Vol, 
1. No. 3-4. Pages 197-207. 1976. 

Green. Alexander A.. M. D.. Hustu. H. Omar. M. D.. et al. "Total-Body Sequential 
Segmental Irradiation and Combination Chemotiierapy for Children with Disseminated 
Neuroblastoma". Cancer . Vol. 38. Pages 2250-2257. 1976. 

Jenkin. R.D.T., M. B., & Berry, M. P., M. B., "Sequential Half-Body Irradiation in 
r.hnrihnnri- IniPrnatinnal Journal of Radia tion Onfioioav RIolonv & PhvsicS. Vol. 9, Pages 
1969-1971. 1963. 

Montebeilo, Joseph F., M. D. & Hartson-Eaton, Mary, Ph. D., "The Palliation of Osseous 
Metastasis with 32p or 89Sr Compared wtih External Beam and Hemibody Irradiation: A 
Historical Perspective", CanoRr Investigation . Vol. 7 No. 2 Pages 139-160, 1989. 

Payne, David G., M. D., F.R.C.P., Yeoh, Um, M. D., F.R.C.P., et al. "Upper Half Body 
Irradiation (UHBI) For Extensive Small Cell Carcinoma of the Lung", International Journal Of 
Radiation Oncology. Biology & Phvsics . Vol. 9, Pages 1571-1574, 1983. 

Poulter, C. A.. M. D., Cosmatos, D., Dr. et al, "A Report of RTOG 8206: A Phase III Study 
of Vftiether the Addition of Single Dose Hemibody Irradiation to Standard Fractionated Local Field 
Irradiation is More Effective than Local Field Irradiation Alone in the Treatment of Symptomatic 
Osseous Metastases", International Journal of R adiation Oncology. Biology & Physics. Vol. 23. 
Pages 207-214, 1992. 

Powell, Bayard, M. D., Jackson. Don V.. Jr., M. D., et al, "Sequential Hemibody and Local 
Irradiation with Combination Chemotherapy for Small Cell Lung Carcinoma: A Preliminary 
Analygjc- IntPrnationa! Journal of Radi ation Oncology Rioloqy & Phvsics. Vol. 11, Pages 457- 
462. 1985. 

Qasim, M. M., "Half Body Irradiation (HBl) in Metastatic Carcinomas",_Clini£al 
Radiology. VoL 32. Pages 215-219, 1S81. 

Rowland, C. G., Bullimore, Jill A., et al, "Half-body Irradiation in the Treatment of 
Metastatic Prostatic Carcinoma", British Journ al of Uroloov. Vol. 53, Pages 628-629, 1981. 

Rubin. Philip, M. D., Salazar, Omar, M. D., et al, "Systemic Hemibody Irradiation for 



Page #4 



221 



Overt and Occult Metastases". Cancer. Vol. 55. Pages 2210-2221, 1985. 

Rubin. Philip. M. D.. & Heilmann. Hans-Peter. M. D.. "Large Field Trials", 
International Journal of Radiation Oncology Biolo gy & Physics. Vol. 124, Pages 565-576, 
1988. 

Salazar, Omar M., M. D., Rubin, Philip, M. D., et al, "Single-Dose Half-Body 
Irradiation for Palliation of Multiple Bone Metastases from Solid Tumors", Cancer . Vol. 58, 
Pages 29-36, 1986. 

Thatcher, Nick. Ph. D.. FRCP. Anderson. Heather. M. D.. MRCP, et al. "Treatment of 
Metastatic Melanoma by 24-Hour DTIC Infusions and Hemibody Irradiation". Cancer . Vol. 57, 
Pages 2103-2107, 1986. 

Urtasun, R. C, M. D., Belch, A., M. D., et al. "Hemilxxly Radiation, an Active Therapeutic 
Modality for The Management of Patients with Small Cell Lung Cancer". International Journal of 
Radiation Qncoloav. Bioloov & Phvsics. Vol. 9. Pages 1575-1578. 1983. 



Page #5 



222 



oOfficc^^Aemordndu7n • united states government 

W> I Chief, Radiological Service dates 20 October 1958 

Walter Heed Aray Itedical Center 

ZKOM I Assi Chief, Biophysics and Astronautics Research Branch, U. S. AtsQT 
Kodical Research and Oevelopaoot Cocsnand 

SOBjrcT! Application for Research Contract 



• 1. The inclosed" copy of research proposal entitled, "Metabolic Chances la 
Ifecans ?olloin.nc Total Body Radiation," has been subnitted for our consideration ly 
Dr. Eu^eno L. Sacnger of the University of Cincinnati, College of Medicine, 
Cincinnati, Oiio. t 

2. Request review of the attached proposal and please give your reeo^sendaticn 
as to whether or not this study should be supported by the Army Medical Service. 




1 Ind 

OTSG Fom 108 

IOj Asst Ch, Biophysics £ Astronautics FROM: ChieT, Radiological DATE: 22 Oct 195: 
Research Branch, US Arcy Medical Svc, VRAH • Coll3horwood/r]c/6: 

Research & Developnent CoisBand 

1.. Recoanend approval. 

2. Ifuch work has been done on the effects of total body irradiation la anlrals. 
Ibere has been no real effort to date for sisilar studies on huisans. The validity 
of the assusption that ahiaal reaction is Identical \ri.t)x that in^uaans is purely 
assuaption. There is definite need for basic work in this field. Any corrslatlea 
of tu:or response to total dose of irradiation by such ceana as pr«p«sed in this 
pro J e c t would be of great value in the field of cancer. In addition' If by 9<»e 
ceans snch as those proposed accurate knowledge of the total dose of radiation 
received could be determined it would be of Inestinable value in case of atcalc 
disaster or nuclear warfare. The applicant. Dr. Saenger, Is well qualified to 
conduct such research. He is not only an enthusiastic and tireless worker t«t has 
the ability to stlaulate his co-workers and assistants. He has an unusual taalf-lzt 
rind and is an excellent organizer and administrator. 1 believe the facilities 
vhich he has available are well adapted to the project. It is believed that asy 
l^inds spent on such a project are well worthwhile. 






1 Ind /mn A. ISHEKVroOD 

«/c /eolonel, MC 

Chief, Radiological Service 



223 



COSSEOT FOR SPECIAL STUDY AND -REATJIDJT 



^t— . • do hereby give my consenC 

to the nembers or the professional staff of the Cincinnati General Hospital, 
Dnlvcrslty of Cincinnati College of Medicine, to administer to m e vhole at partial 
tody Irradiation on or about , 196 . 

The nature and purpose of this therapy, possible alternative methods of 
treatment, the risks involved, the possibility of complications, and prognosis have 
been fully explained to me. The special study and research nature of this treat- 
ment has been discussed with me and is understood by me. 

Consent is given for photographs and publication for the advancement of 
ziedical education. 



Signature 



Witnesses to signature: 



Relationship_ 



Date 



Place 



(patient or guardian) 

AM 

PM 



(Mo. Day Yr.) 



(Ward - Clinic - Unit) 



Original: to patient's chart 
Copies: to Co-60 file 
to TBR file 



Chart No. 



5/1/65 



224 



CONSENT FOR SPECIAL STUDY AJID TREATMENT 



1. 



do hereby give my consent 



to the meiiers of the professional staff of the Cincinnati General Hospital, 
University of Cincinnati College of Medicine, to perform a bone narrow aspiration 
«nd to store my bone marrow on or about 196 

ae nature and purpose of this therapy, the risks involved, the possibility 
of ennpllcations , and prognosis have been fully explained to ne. The special 
study and research nature of this treatment has been discussed with db and is 
tmderstood by me. 

Consent Is also given for relnfuslon (giving the narrow back to me) when the 
members of the professional staff reconunend it. 

Consent is given for photographs and publication for ihe advancement of 
aedlcal education. 



Witnesses to signature: 



Signature 
Relationship_ 



Date 



(patient or guardian) 
AM ~ 

PM 



(Mo. Day Yr.) 



Place 



(Ward - Clinic - Unit) 



Original: to patient's chart 
Copies: to Co-60 file 
to TBR file 



Chart Ko. 



5/1/65 



225 



UKIVERSITY OF CINCIN'N'ATI MEDICAL CENTER 

FACULTY CO>MITTEE ON RESEARCH 
VOLL'^JTARY CON'SEST STATEIENT 



of 



(Facient) (normal subject) (place - city) 

being of the age of majority and of sound mind and body, voluntarily and without 
force or duress, consent to participate in a scientific investigation which is not 
directed specically to my own benefit, but in consideration for the expected 
advancement of medical knowledge, which may result for the benefit of mankind. 

1 have been informed of and understand the nature, duration, and purpose of the study, 
the method and means by which it is to be conducted, the inconvenience and hazards 
to be expected, and the effects upon ny health and person which may possibly come 
from partlcipaticn in the experiment, as follows: 

Purpose: To kill tumor cells and at the same time study the effects of radiation 
on blood and urine: 

Procedure: Radiation of the whole body. 

msks: The chance of infection or mild bleeding to be treated with marrow trans- 
plant, drugs, or transfusion as needed. 

I understand that I may, at any time during the course of the experiment, revoke ny 
consent, in writing, and withdraw from the experiment. 

I acknowledge that no guarantee or assurance has been made to me as to the results 
that may be obtained, and I hereby waive any and all claims for liability, except 
for negligence, on. the part of the medical personnel involved, the University of 
Cincinnati, its Hospital and its Medical School, which othen^ise might have inured 
to me or my heirs, is a result of this medical procedure. 

1 certify that I have read and am competent to fully understand this consent and 
that the explanations listed above were, in fact, made. 

Voluntee r ^Date^ 

Investigator Date 

Witness (1)^ Date 



*ln case of subject under age, the parent or guardian should be the responsible party 
and should sign on his behalf. 

KDTE: Copy to Patient/normal subject. Research File and Patient's Chart. 



226 



I certify ctiat I have read and am coopeccnc to underatand this 
conaent and that the explanation listed above was. In fact, oiade. 

Volunteer Date 



Investigator pate 



(fitness (1) ^Date 



* Incase of subject under age, the parent or guardian should be the 
responsible party and should sign on his behalf. 

ROTE: Copy to Patlent/Noraal subject. Research File and Patient's Chart. 



227 



FACULTY CO>CIITTEE OH RESEiVRQl 
VOLUllTARY CONSENT STATEMENT 



*1 of. 

(Patlenc) (Normal subject) 



being of the age of najorlty and of sound mind and body, voluntarily and 
without force or duress, consent to participate in a scientific investi- 
gation which is not only directed specifically to ny oun benefit, but 
also In consideration for the c:qpectcd advanccxcnt of medical knowledge, 
«diich may result for the benefit of mankind. 

I have been Informed of and understand the nature, duration, and purpose 
of the study, the method and means by which it is to be conducted, the 
Inconvenience and hazards to be expected, and the effects upon my health 
and person which may possibly come from participation in the experiment, 
as follows: 

Purpose ; To kill tumor cells and at the some time study 
the effects of radiation on blood and urine. ' . 

Procedure; Radiation of the whole body. 

Risks ; Radiation treatment employed is used to kill tumor cells 
but at the sane time other, normal, cells of your body will be 
affected. The only cells affected which would cause any risk to 
you are those cells in your bone marrow. The bone marrow is a 
"blood factory" where white cells that fight infection, the 
platelets which help blood clot, and the red cells which carry 
oxygen to your tissues arc made. The bone marrow's ability to 
make these cells will be decreased for four or five weeks after 
^♦ou receive your radiation. If you receive a dose of radiation 
of 200 rads or more, which your doctor will tell you, your blood 
counts will fall to levels where Infection or bleeding could be 
a problem. The bleeding can be treated by transfusion of red cells 
and platelets and the infection by antibiotics. In addition, we • 
prevent such low blood counts with the use of a bone narrow trans- 
plant which will be discussed with you In a separate voluntary 
consent statement. If your radiation dose is only given to 
part of the body there is no risk of danger or unusually low 
blood counts. 

I understand that I may, at any time during the course of the experiment, 
revoke my consent, in writing, and withdraw from the experiment. 

1 acknowledge that no guarantee or assurance has been made to mc as to the 

results that may be obtained, and I hereby waive any and all claims for 
- " JLlability, except for negligence, on the part of the medical personnel 
, Involved, the University of Cincinnati its Hospital and its Medical 

School, which otherwise might have inured to me or my heirs, as a result 

of this medical procedure. 



228 



X certify that I have read and- am competent to understand this 
coHritMit iinJ that the explanation llatcJ above uas. In tact, made. 

Voluntrcr Date 



laves tljtut or patc_ 



Vltnr.is (1) nate_ 



* Incase of subject under age, the parent or (>uanllan should be the 
rcapuuslblc party and should sign on hlu behalf. 

NOTE: Cppy to Patient/Normal subject. Research File and Patient's Chart. 



229 



BIOCHEMICAL AND BIOLOGICAL TESTS FOR PATIENTS UNDEROaNG 
TOTAL BODY IRRADIATION AND PARTIAL BODY IRRADIATION 

Pre and Post Radiation Observations* 



1 . Complete history and physical examination 

2. Hematocrit, hemoglobin, leukocyte count and differential 

3. Electrocardiogram, chest X-ray, urinalysis 

4. Sequential multiple analyses (SMA-12) for blood chemistry determination, 
prothrombin time, creatinine phosphokinase levels, partial thromboplastin 
time 

5. Blood and urine amylase 

6. Ultraviolet absorbing compounds in urine 

7. Bone marrow aspiration 

8. Blood typing and cross matching if bone marrow transfusion is to be done 

9. Tritiated thymidine uptake for lymphocyte viability 

1 0. Histochemistry and electron microscopy of bone marrow pre and post 
etiocholanolone 

1 1 . Chromosome analysis 

12. Nitroblue tetrazolium study of granulocyte function 

13. Serum glycoprotein assay 

1 4 . Serum amino acid assay 

15. Bacteriophage titers 



230 



16. Urinalysis for hydroxyproline levels 

17. Psyclnoiogical testing 

18. Urinary taurine for correlation with leukocyte count 

19. BAIBA in urine 

20. Kynurenic and xanthurenic acids 

21. Deoxycytidine 

22. Xanthine and hypoxanthine in urine. 

23. Urinary phosphate 

24. Glutathione 

25. Routine electrophoresis and immunoelectrophoresis 

26. Quantitative precipitin studies 



These observations and tests have varied as some tests do not seem useful and new ones 
suggest that they may be valuable. 



file: Position/Appendix 4 



231 



Reprinted from 

The Amtriean Journal of Roentgmology, Radium Therapy and Nuettar Medicine 

VoL CXVII, No. 3. March. 1973 






WHOLE BODY AND PARTIAL BODY RADIOTHERAPY 
OF ADVANCED CANCER* 

By EUGENE L. SAENGER, M.D., EDWARD B. SILBERSTEIN, M.D., 

BERNARD ARON, M.D., HARRY HORWITZ, M.D., 

JAMES G. KEREIAKES, Ph.D., GUSTAVE K. 

BAHR, Ph.D.. HAROLD PERRY, M.D.,t and 

BEN I. FRIEDMAN, M.D.J 

CINCINNATI, OHIO; DETKOIT, MICHIGAN; AND MEMi'HIS, TENNESSEE 



'T^HE purpose of these investigations has 
-■• been to improve the treatment and 
general clinical management and if possible 
the length of survival of patients with ad- 
vanced cancer. Systemic effects of radiation 
therapy have been given particular atten- 
tion in our work. 

In the period- February 19, i960, through 
August 31, 1971, 85 adults were given 
whole or partial body radiation as therapy 
for far advanced cancer. 

This paper will report on the survival of 
patients in 3 categories: colon; lung; and 
breast. 

Prophylactic whole body radiation ther- 
apy was given to 3 children with localized 
Ewing's sarcoma and this experience will be 
discussed briefly. 

Investigations of biochemical, cytologic 
and psychologic tests have been reported 
elsewhere.'"" 

Our experience with the adjuvant use of 
autologous bone marrow will also be 
described. 

ANIM4L STUDIES 

The animal investigations basic to our 
work stem from the studies of Hoilcroft 
et al}*-^^ These authors demonstrated bet- 
ter tumor regression when whole body ir- 
radiation was preceded by localized radia- 
tion therapy than when localized radiation 
therapy was given alone both for lym- 
phoma and carcinoma in mice. The studies 
of Jacobson el al}*-^* showed the impor- 

• Presented »t the Seventy-third Annual Meeiine of the Americ in Rornigen Riy Society, Wiihington, D. C, October j-6, 1971. 

From the Departments of Radiology, Internal .Medicine and Radioisoti'pe Laboratory, Unirersity of Cincinnati College of Medicine, 
Gncinnati, Ohio. 

t Radiation Therapy Department, Sinai Hospital of Detroit, Detroit, ^f ichigan. 

} Division of Nuclear Medicine, Department of RadioloiM , l'niver<i: of Tennessee, Memphis, Tennessee. 

Supporrel in p«rt by USPHS RR 5408, NIH General Researc' Support Grant of the College of Meiicine, University of 
Cincinnati. 

670 



tance of shielding of the spleen and other 
organs and parts of the body in preventing 
high dose radiation lethality in the mouse. 

BRIEF REVIEW OF TOTAL BODY 
IRRADIATION IN MAN 

Total body irradiation was first em- 
ployed in 1923 by Chaoul and Lange.' Its 
use in 270 cases over the next 20 years was 
reviewed by Medinger and Craver." These 
authors found the greatest palliation in the 
lymphomas and myeloproliferative diseases, 
but also noted improvement in multiple 
myeloma. Thirty-five patients with ad- 
vanced carcinoma or sarcoma were in- 
cluded in this series, most of them receiving 
their total body radiation between 1931 
and 1933. 

Loeffler el al.*' compared total body 
irradiation in single doses up to 150 r with 
nitrogen mustard and triethylene melamine 
and found that neither chemotherapy nor 
radiotherapy differed in hematologic ef- 
fects, but that the patients receiving radia- 
tion did not experience the malaise of var>'- 
ing severity noted by all patients receiving 
the chemotherapeutic agents. Subjective 
improvement was noted only in the radio- 
therapy group. 

Collins and Loeffler* gave total body 
irradiation in single exposure up to 200 
roentgens and found this form of systemic 
therapy "a useful addition to the manage- 
ment of advanced cancer." The malignan- 
cies treated included lymphoma, chronic 



232 



Vol. 117. No. j 



Whole Body Radiotherapy of Advanced Cancer 



671 



myelogenous leukemia and multiple mye- 
loma. 

Interest in total body irradiation in the 
treatment of Ewing's sarcoma, a tumor of 
children which carries a high mortality, has 
been aroused by rei>orts from Milbum 
et al.J* Jenkins tt al.^ and Rider and 
Hasselback." In a small series so treated, 
survival appeared to be moderately im- 
proved compared to larger series treated by 
conventional local radiotherapy and/or 
ablative surgery. These groups felt further 
evaluation of this form of therapy to be 
most important. 

Additional data have been published by 
the Medical Division of Oak Ridge Asso- 
ciated Universities,' concerning total body 
radiation therapy of lymphoproliferative 
and myeloproliferative disease. 

Summaries of the frequent use of total 
body irradiation for the therapy of leu- 
kemia appear in an article by Buckner 
et al.* and in a comprehensive review of 
bone marrow transplantation by Bortin.* 

Whole body radiation in routine clinical 
therapy has been and is currently used for 
leukemia,"" lymphoma,**-"-" Hodgkin's 
disease,* polycythemia vera,* cancer of 
breast," cancer of thyroid,* cancer of pros- 
tate,"** and multiple myeloma.*** Such 
therapy may be given by external radiation 
therapy (as in this particular study) or in 
the form of various radionuclides. 

STUDY DESIGN 

The studies reported here were initially 
considered as being in Phase I (to deter- 
mine whether the treatment was toxic or 
not) and subsequently as Phase II (whether 
treatment appears effective or not but 
without controls). In reviewing these data 
it has been possible to find some compara- 
ble material in the literature. In one cate- 
gory, cancer of bronchus, comparable dau 
were available in our institution. 

INrOMfCO CONSENT AND INtTmrnONAL KEVIEW 

All patients gave informed consent in 
accordance with directives of the Faculty 
Research Committee of the University of 



Cincinnati College of Medicine and those 
of the National Institutes of Health. The 
use of formal informed consent forms in 
this study antedated the above require- 
ments by 2 years. The project is reviewed 
and approved regularly by the above 
Committee. 

EUciBiLrrv or patients 

Patients become eligible for this form of 
treatment if they have advanced cancer for 
which cure could not be anticipated. Three 
children with localized Ewing's tumor at 
Children's Hospital were given whole body 
radiation as part of the curative attempt 
after the primary tumor had been ablated 
with local radiotherapy. 

Biopsy proof of the malignancy has been 
established in all instances. Clinical data in 
each case have been reviewed by several 
physicians to be certain that the tumor had 
indeed extended from its primary- site and 
that curative therapy was not applicable. 
This preliminary evaluation is followed by 
an observation period of 7-1 4 days to ob- 
serve the general condition of the patient 
and to carrj' out baseline laboratory tests 
to be as certain as possible that the condi- 
tion of the patient is relatively stable. Fre- 
quently this determination is difficult since 
the patients have serious illnesses of long 
standing and often have had considerable 
previous therapy. 

Patients remain in the hospital as long as 
is necessary. Prior to the use of autologous 
bone marrow transfusion, hospitalization 
was occasionally as long as 8-10 weeks. 
Length of stay was also dependent upon the 
severity of the clinical manifestations stem- 
ming from the cancer. With the use of par- 
tial body irradiation and bone marrow infu- 
sion, hospitalization has been greatly short- 
ened. The follow-up procedure is continu- 
ous during the lifetime of the patient. 

A total of 112 subjects were initially 
entered in the study through August 31, 
1 97 1. During the screening period of 7-14 
days, 24 of them (ii per cent) were not 
continued in the study and did not recdve 
whole or partial body irradiation. Chief 



233 



672 



Saengcr et al. 



Makcb, I97J 



among the reasons for elimination was an 
indication in the pretreatment phase that 
some risk from wide-field radiation might 
ensue or that another method of treatment 
was considered preferable. In some, a very 
rapid progress of the disease made inclusion 
undesirable. The treatment was completed 
in 85 adults and 3 children between April 
i960 and August 31, 1971. Three patients 
have received 1 separate courses of treat- 
ment in this program. Follow-up time for 
survivors is reported through August 31, 
1972. 

PATIENT DOSIMETRY 

The radiation is delivered by a cobalt 60 
teletherapy unit under the following expo- 
sure conditions: The beam is directed hori- 
zontally at a wall 342 cm. away with the 
midline of the patient at 286 cm. from the 
source. For whole body exposures, the radi- 
ation beam size for the 60 per cent isodose 
curve at the patient midline distance is a 
square approximately 1 20 cm. X 1 20 cm. 
The patient is placed in the sitting position 
with legs raised and head tilted slightly 
forward. Radiation is given by delivering 
half the specified exposure laterally through 
one side of the patient, the patient is then 
turned and the other half exposure deliv- 
ered laterally through the other side. The 
combined dose of the 2 radiation fields 
provides a good homogeneous dose distri- 
bution through the patient. The maximum 
variation in lateral dose distribution was 
+ 13 per cent for i patient who had a lateral 
trunk dimension of 36 cm. 

The exposure to the patient is deter- 
mined using a percentage depth dose table 
corrected for the source-to-skin distance 
used for the patient. Using the corrected 
depth dose at patient midline (1/2 lateral 
dimension at the trunk in the plane of the 
xiphoid) and a conversion factor of 0.957 
rads/roentgen for cobalt 60 gamma radia- 
tion, the midline air exposure required to 
g;ive a desired midline absorbed dose in 
rads is calculated. The validity of this pro- 
cedure was established with measurements 
in an' Alderson Rando Phantom using 



thermoluminescence dosimeters. Over the 
course of the study, the air exposure rates 
at the distance indicated above varied from 
3 to 6 per minute. 

For individuals receiving partial body 
radiation, the teletherapy collimator is used 
to restrict the beam. The xiphoid is used as 
the boundary of the field for upper and 
lower body exposures. The lateral dimen- 
sions of the patient in the plane of the 
xiphoid is again used for calculating the 
desired midline dose. As for the whole body 
exposure, the dose is delivered bilaterally. 
Additional information on the dosimetry 
aspects of this study has been published by 
Kereiakes et alJ' 

AKALYSIS or SURVIVAL DATA 

In considering the survival data there 
was a lack of consistent selection bias both 
in recommendation that a patient be eligi- 
ble for treatment and in regard to the dose. 
The principal investigator had no part in 
determination of therapy in any given case 
except for outlining the general principles 
of the therapeutic regime. The choice in the 
case of each patient was made by several 
radiation therapists, 3 having been asso- 
ciated with the project during the 10 year 
period. In addition, 2 internists have had 
active roles in the selection and medical 
care of each patient. The dose of radiation 
to be given was decided upon by the radia- 
tion therapist in consultation with the 
internist. 

There are 3 categories of patients (those 
with carcinoma of the colon, lung and 
breast) which are large enough to permit 
some analyses of survival. Each group will 
be discussed separately. 

Survival data are given in days from the 
diagnosis of far advanced disease, since this 
convention has been used frequently in the 
literature and permits comparison of our 
survival data with published reports. 

CANCER or THE COtOK AKD RECTOM 

Twenty-nine patients with this tumor 
comprised the largest single category (Ta- 
ble 1). In all cases the patients were classed 



234 



Vol. 117, No. J Whole Body Radiotherapy of Advanced Cancer 

Table I 

CANCKK or OOLOM — ALL CASES ET LEMOTH OF SURVITAL OF AOyANCEO DISEASE 

(39 Padena) 



67J 



Study No .• 



Age 



Scx/Rmc 



Survival After Survivml After 
D. (dsys) R. (days) 



Doset(rads) 



106 


58 


F/W 


40 


>5 


300 LB 


109 


56 


M/W 


116 


80 


300 LB 


05s 


60 


M/W 


ISO 


91 


200 LB 


033 


64 


M/N 


136 


86 


100 


081 


49 


F/N 


136 


33 


300 LB 


OIJ 


61 


M/N 


143 


33 


100 


007 


63 


M/N 


181 


ISI 


too 


o«7 


S» 


F/N 


193 


163 


100 LB 


049 


75 


M/N 


313 


169 


200 LB 


050 


80 


M/N 


330 


«97 


200 UB 


036 


64 


M/N 


36t 


338 


too 


064 


54 


F/N 


363 


188 


300 LB 


091 


62 


F/W 


395 


5a 


200 


o6j 


38 


M/W 


399 


344 


300 LB 


066 


63 


M/N 


3*7 


303 


200 LB 


107 


58 


F/W 


347 


S9 


200 


047 


57 


M/W 


4" 


U7 


150 LB 


III 


5» 


F/N 


434 


307 


200 


06s 


60 


M/N 


451 


870 


150 


096 


4» 


M/N 


5«3 


439 


100 


"3 


7» 


F/N 


633 


381 


100 


098/ioj 


45 


F/N 


913 


474 


200^3^0 LB 


020 


69 


F/N 


946 


88; 


200 


006 


67 


M/W 


983 


740 


54 


tot 


76 


M/N 


9«3 


86« 


257 LB 


100 


76 


M/N 


1,358 


900 


300 LB 


013 


44 


M/N 


1,361 


651 


300 


095/104 


66 


F/N 


1.437 


704 


200+300 LB 


108 


66 


F/W 


1,691 


584 


300 UB 



* Study N& refcn (D the foctcr of p«cicau dcMTibcd wriiUr in Technical R«porti: No. 6-t s<*. lS-«9«>, ]i-]6«,6-64« 66-70". 77-4 1«, 
•3-9i*,j»-toj*, lo*-!!!", lii-it3pcrK>n>lcommunic«aaB.''' 

t DoK in nit at the midline Where 00 letter feUowa the doec. whok body radiaiiea «aa givea. LB •■ lover bodr oradiatiea; 
UB — upper body ifTadiatiao. The di*idia( point ia the ophoid. 

Median a uni i a l — jrj dajrt 



as far advanced and in a few instances as 
terminal. Four patients were not included 
in the study for medical reasons, or because 
the patients themselves declined participa. 
tion in the study. 

In order to make an appropriate corn* 
parison, several published series were re- 
viewed. Series of cases of colon cancer 
metasudc to liver were utilized, since they 
were the best found by us with appropriate 
time periods of metastasis available for 
comparison. Steams and Binkley,** in J2 
patients with colon cancer with liver metas- 



tases, found a median survival time of 1 1 
months after palliative resection of the 
primary tumor; in 28 of their patients in 
whom only biopsy or diversion was per- 
formed, the median survival was 8 months. 
In 353 patients with untreated colon cancer 
metastatic to liver, Pesuna et a/." reported 
a median survival of 9 months. Figure i 
presents an analysis of 177 patients with 
liver metastases and no subsequent therapy 
reported by Jaffe et al.** There is also a 
group of 61 padents reported by Rapoport 
and Burleson** treated with 5-fluorouraciL 



235 



674 



Sicnger et aL M*tcN,i97] 

SURVIVAL COMPARISONS 
CANCER OF COUON METASTATIC TO UVER 



STOiEWWt O IT Tft « PT$.(U£J 

er GREENWOODS « 9FU Rx rrs. 

MCTHOO A <l«0»«»art Mol SGA OO TTi-rn 979 

177 UntTMMd m 
Q (Joff* Ml S.fta tZ7:MI,l»S« 




"» a 30 38 

SURVIVAL TME M MONTHS 

Fic. I. 



The 22 patients in our series with proven 
metastatic carcinoma of the colon to the 
liver treated by irradiation are also shown 
in Figure i . 

The median survival time for untreated 
patients was I46 days; for patients treated 
only with 5-fluorouracil, 255 days; and, 
among our patients with liver metastases, 
391 days (Table 11). A life table analysis 
was performed and indicates that the treat- 
ment given to our patients was approxi- 
mately equivalent to the group given 5- 
fluorouracil. There was no evidence that 
the median survival time was shortened by 
total or partial body irradiation (Fig. i). 
It should be appreciated that 5 of our pa- 
tients had received or are receiving 5-fluoro- 
uracil in addition to the radiation therapy 
(3 of these with liver metastases). 

The median survival for the entire group 
of 29 patients (22 with liver metastases) 
was 327 days. 



CAKCER or THE BROKCHUS 

This group of 15 patients (Table in) had 
far advanced disease with distant metas- 
tases at the time of treatment. The best 
comparison group was from our own insti- 
tution reported by Horwitz e/ al}* The 
median survival of the 1 5 patients receiving 
whole body irradiation was 193 days from 
the time of diagnosis. The median survival 
of 61 patients seen at Cincinnati General 
Hospital from December, 1961, to June, 
1964, was 135 days. In 15 of the 17 cases 
with distant metastases excluded by Hor- 
witz el al. from their study (see caption to 
Fig. 2), the median survival was 32 days. 

This last group of patients with distant 
metastases constitutes the most appropri- 
ate comparison group. When the median 
survival* of 15 patients mentioned by 
Horwitz et al}* is compared with the 15 

• Two of the 17 patient* excluded in the Honriti ri •!■" ttudy 
were trcited bjr whok body ridittion. 



236 



Tei.. 117, No. 3' 



Whole Body Radiotherapy of Advanced Cancer 



675 



patients treated by whole body irradiation, 
the survival times are significantly different 
(Chi square 11.63, p<o.oo5) (Fig. 3). 

EWINC'S TUMOR 

This subgroup of 3 patients constituted 
the only one in which an attempt at cura- 
tive therapy was made; all 3 patients are 
surviving. The times of survival are 854, 
1,143 *"d 1,553 days from the time of diag- 
nosis to August 31, 1972. The patient with 
the longest survival has recently developed 
a solitary pulmonary metastasis. The use 
of whole body irradiation to eliminate 
small clumps of cells in the disease has been 
reported by others."*** 

A fourth patient with Ewing's tumor had 
pulmonary metastases when first seen. 
Therapy in that case was only palliative. 

Table II 

CAKCER or COLOK— CASES WITH 
METASTASES TO LIVER 

(21 Patients) 



Study 
No.* 



Survival After 
D. (days) 



Survival After 
R. (days) 



106 


40 


aj 


109 


116 


80 


052 


120 


9» 


033 


126 


86 


082 


136 


33 


OIJ 


143 


121 


067 


193 


163 


036 


261 


238 


091 


295 


ja 


066 


327 


203 


107 


347 


89 


III 


434 


307 


062 


451 


270 


096 


J83 


439 


113 


632 


J8l 


098 


912 


474 


006 


982 


740 


lOI 


983 


864 


100 


I,2J8 


900 


023 


1,261 


651 


09J 


",437 


704 


108 


1,691 


584 


* See footnou to Ttble i. 




Mcdita nrrtTi)— 391 


(Un. 





Table III 

LUNC CANCER — SURVIVAL IN DAYS AFTER Dx 

(15 Patients) 



Study 
No.* 



Survival 

After Di 

(days) 



Survival 

After R, 

(days) 



Dose 

(rads) 



053 


J7 


28 


200 


056 


lOJ 


38 


100 UB 


086 


116 


20 


100 


078 


126 


61 


200 


088 


>3J 


7 


150 


081 


144 


14 


100 


051 


'6j 


74 


ISO 


070 


193 


68 


150 


102 


266 


22 


200 Trunk 


018 


333 


298 


200 


044 


349 


196 


100 


on 


4>9 


3^3 


100 


112 


683 


403 


100 


OIJ 


797 


33 


ISO 


084/097 


85J 


643 


300 UB+ioo 


* Sec footnote to Tible 1. 






Mediu turnval — 19] dart. 







CANCER or THE BREAST 



In 15 cases treated by us the median 
survival from diagnosis to death was 479 
days and after treatment to death was 446 
days (Table iv). Two comparable reports 
in the literature include the one by the 
Committee on Estrogens and Androgens" 
and the other by Samp and Ansfield using 
5-fluorouracil.*' Again a life table analysis 
was done for our 1 5 patients and indicates 
that the survival of our patients appears 
somewhat better than that of the patients 
treated solely by estrogens and androgens, 
but not quite as good as the group treated 
with 5-fluorouracil (Fig. 4). The patients 
survive longer than those receiving the 
"standard therapy" as described by Samp 
and Ansfield;" this includes appropriate 
administration of estrogen and androgen, 
oophorectomy, local irradiation, adrenalec- 
tomy and hypophysectomy. 

OTHER CANCERS 

A remaining group of 25 cases reflected 
several different kinds of cancer. It is not 



237 



676 



Saenger et al. 



M«aea, ij7j 



SURVIVAL BY ACTUARIAL METHOD FOR 61 PATIENTS WITHOUT EVIDENCE OF DISTANT METASTASES 

AT FIRST PRESENTATION 
lOO-t »7 * 




UietrteiRty Bon 

Shm 1 1 Standord Error 



lot 



I 



2 



-r 
3 



I I 

6 7 

Mentha 



6 



-r 
9 



10 II 



-T" 
12 



Fio. 2. The survival by actuarial analysis is shown for a total of 61 patients with carcinoma of the bronchu* 
and distant meustases, who presented between December, 1961 and June, 1964 at Cincinnati General 
Hospital. The only patients excluded from this group are those in whom distant metastases were present 
at the time of diagnosis (17 patients). If they were to be included, the I year survival figure would drop 
to about 7 per cent. It is emphasized that these figures uke account of all cases seen (including those 
apparently "early" and amenable to complete surgical resection). Although other reported figures may be 
somewhat higher, differences are more realistically attributable to biologic factors rather than to 
therapy.'^ 



possible to make an analysis of these at this 
point sinre the individual case groups are 
too small to warrant this 

DISCUSSION 

KELATIOV or RADIATION THERAPY TO 
PATIENT DEATH 

Some analyses can be made which give 
information on this pxjint. 

The doses of whole body radiation given 
could initiate only the hematologic form of 
the acute radiation syndrome. In the 
healthy individual, after prodromal symp- 



toms of malaise and vomiting lasting about 
6-48 hours, there is a latent period lasting 
until 18-21 days after exposure. At this 
time there is a marked rapid fall in white 
blood cells and platelets and a less rapid 
fall of red blood cells reaching a nadir at 
30-40 days and then recovering. These 
changes are associated frequently with 
episodes of infection and bleeding. Epila- 
tion will occur at doses over 300 rads. 

Many of these patients had received 
much radiation and chemotherapy prior to 
total or partial body treatment and in 



238 



Vol. 117, No. ] 



Whole Body Radiotherapy of Advanced Cancer 



677 



SURVIVAL COMPARISONS 
CANCER OF BRONCHUS WITH METASTASES 



TSTBDWOR OMPWi^tT TBR or PBR(U.CJ 

BY OftCENWOOtfS ^IS P«i«ni« T didoni mmemnm 

asZMwM In cMoramfaudl ttudyCUfJ 




n 


H 


























^ 

















■*- 



-ir 



^0 



Fio. 3. 



many cases this treatment was followed 
immediately by planned local therapy to 
various portions of the body. 

If one assximes that all severe drops in 
blood cell count and aU instances of hypo- 
cellular or acellular marrow at death were 
due only to radiation and not influenced by 
the type or extent of cancer and effects of 
previous therapy, then one can identify 8 
cases in which there is a possibility of the 
therapy contributing to mortality. Of this 
subgroup, 2 patients received localized 
radiation between total body irradiation 
and death at 31 and 32 days, respectively. 
Two had extensive previous chemotherapy 
and I also had local radiotherapy. In 2 
other cases, autologous marrow transfusion 
was unsuccessful because the preradiation 
marrow was hypocellular. Both of these 
latter patients had had intensive localized 
irradiation and i had received intensive 
chemotherapy. 



Taile IV 

CAKCER or BREAST — SCRTTVAL POST D. 

(ij Patients) 



Study 
No.* 



Survival 

After D, 

(days) 



Survival 

After R, 

(days) 



Dose 
(rads) 



089 


lOI 


16 


300 Trunk 


05 J 


175 


156 


200 UB^ 


039 


I8j 


15a 


150 


060 


316 


30 


'JO ,., 


045 


138 


a5 


'50 1 l^ 


oii 


473 


10 


150 >*• 


094 


473 


354 


i5oTniak 


031 


479 


446 


too 


079 


5J4 


309 


100 


010 


783 


4* 


100 


C08 


i,oj6 


91 


100 


03s 


1,068 


859 


150 


040 


«.09J 


1,063 


100 


083 


1,098 


164 


100 


09a 


1,308 


1,143 


150 Trunk 



* Sec (oocsott to T«Uc L 
Mcdiia tarfini—4ft i»ja. 



239 



678 



Saenger et at. 

SURVIVAL COMPARISONS 
CANCER OF BREAST WITH METASTASES 



M*«CB, I9TJ 



STD. ERROR 
' 0r SREENWOQOS 
METHOO 



O IS T.a-1*RX. PTS.(U.CJ 

O C27 STANOARO RX. P'nL) 
(MMA-I96:724- IMfil^ 




SURVIVAL TME IN MONTHS 
Fio. 4. 



Of the 19 patients who died within 20-60 
days, 1 1 showed clear evidence of well func- 
tioning marrow with steady or rising white 
blood cell counts and absence of bleeding 
and infection at the time of death. 

The time from diagnosis to death of the 
24 patients entered in the study who were 
not treated has been analyzed. There were 
4 who died in a 20-60 day interval : 



Ne.<if 

Jtathi in 

ao-6odays 



Patients 

turtioini or 

dyini at other 

timet 



Total 



Patiena not 

given ndiadon 4 oo 14 

Patients given 

ndiation 19 6j 83 

Fisher's exact probability test yields a p 
value of 0.16, indicating that there is no 
difference between the 2 groups. Therefore 
one may conclude that in other patients 
described, the effect of whole and partial 
body radiation therapy was less important 
in contributing to death than was the ex- 



tent of disease in these patients. Another 
interpretation would be that a physician 
selecting far advanced cancer patients for 
a given treatment would have about the 
same degree of difficulty in selecting any 
form of treatment for these ver>' ill pa- 
tients. The same probabilities, pBO.i9» 
0.2 and 0.21 are found for patients dying 
between o and 20 days post treatment, 
from 0-60 days, and from 20-40 days, when 
compared to the untreated group. Current 
status of survival for these 88 treated pa- 
tients is as follows: 

Prophylactic therapy (Ewing'a tumor) 3 

Othen aurviving at of August ji, 1971 7 

Deaths possibly attributable to irradiation 8 

Deaths attributable to tumor 70 



88 



EEACnONS niOM TREATMENT AMD ErrECTS 
or PALUATIOM 

The acute radiation syndrome develops 
in stages. In the prodromal stage, nausea 
and vomiting of a transient nature occur. 



240 



Vol. 117, No. 3 



Whole Body Radiotherapy of Advanced Cancer 



679 



These complaints are often highly subjec- 
tive; therefore, they are not discussed with 
the patient before treatment. 

The analysis of our 88 treated patients 
shows that 44 per cent experienced no 
symptoms at all, that 27 per cent had tran- 
sient nausea and vomiting within 3 hours, 
14 per cent within 6 hours and 3 per cent 
•within 12 hours. In only 4 patients (4 per 
cent) were the nausea and vomiting of a 
severe nature (Table v). 

These symptoms are no greater than 
found after surgery or after treatment with 
cancer chemotherapy drugs, the reactions 
of which are often far more severe than 
those from these kinds of radiation therapy. 
Lahiri et alP observed that when 5-fluoro- 
iira^l is given orally at a dose of 15 mg./kg. 
daily for 6 days, and then weekly at the 
same dose, nausea, vomiting, diarrhea or 
stomatitis are found in 55 per cent of the 
patients treated, and marrow depression is 
observed in 50 per cent. A recent study by 
the Western Cooperative Cancer Chemo- 
therapy Group, employing 5-fluorouracil 
without a loading dose at 15 mg. /kg./wk. 
for a month, reported mild to major gastro- 
intestinal or hematologic toxicity in 85.5 
per cent of 430 patients." Higgins tt al}"^ in 
treating cancer of the colon using 12 mg./ 
kg. of 5-fluorouracil intravenously for 5 
successive days, observed that 27.9 per cent 
of 359 patients experienced a toxic reaction. 
The same group reported one or more sur- 
gical complications following resection of 
colon carcinoma in 29.6 per cent of 433 
patients. Parsons^/a/.**note that 61-72 per 
cent of patients suffering from so-called 
radiation sickness responded favorably to 
placebo medication, indicating that sug- 
gestibility may have a big part to play in 
the appearance and control of these symp- 
toms. Mukherji et a!}* in evaluating the 
effectiveness of a combination of 4 drugs in 
the treatment of 23 patients with lympho- 
sarcoma and reticulum cell sarcoma found 
severe myelosuppression in 4 patients (17 
per cent) and possibly attributed this de- 
pression to their deaths from infection. 

Durng the latent period of 18-21 days 



Table V 



INCIDENCE or NAUSEA AND VOMfTINC IN 88 CANCEK 

PATIENTS RECErVINC WHOLE AND/OR PAKTIAL 

BODY RADIATION THERAPV 





Patients 


Per Cent 


No nausea or vomiting 


39 


44 


Nausea and/or vomiting up to 

3 hours after R, 
Nausea and/or vomiting up to 

6 hours after R, 


12 


27 
14 


Nausea and/or vomiting up to 
12 hours after R. 


3 


3 


Nausea and/or vomiting up to 
24 hours after R, 


7 


8 


Nausea and/or vomiting up to 
48 hours after R, 





_ 


Nausea and/or vomiting 48 
hours -f- 


4 


4 




88 


100 



the patient is asymptomatic. The period of 
manifest illness then begins with evidence 
of malaise, infection and bleeding. These 
findings occur only with whole body irradi- 
ation and not with partial body treatment. 
Also when marrow is successfully replaced 
these findings do not occur. 

In regard to palliation, a review of pa- 
tient records shows that some palliation was 
achieved in 56 per cent and that 31 per cent 
were made neither better nor worse (Table 
vi). In another 3 cases we were unable to 
obtain follow-up history' concerning pallia- 
tive effects. The 3 cases of Ewing's tumor 
are not included in this table as therapy 
was prophylactic. 

POSSIBLE UNIQUE MECHANISMS Or WHOLE AND 
PARTIAL BODY IRRADIATION 

Whole body irradiation in the doses 
reported herein could be effective against 
cancer in several ways: (1) alteration of the 
immune mechanism of the body altering 
the balance in favor of the host; (2) by a 
direct effect on the metabolism of the can- 
cer cells. In this case wide-field radio- 
therapy would have one advantage over 
drug therapy, since it would reach all can- 
cer cells without depending upon blood 



241 



68o 



Saenger et oL 



Hakm, I97J 



Table VI 

PALUATIVE CrrECTS* or TftEATMEKT 

(85 Patientst) 



Per Cent 


Relief of pain 


3« 


Decrease in tumor size 


3> 


Increase in activity 


»3 


Increase in well being (weight gain, ap- 




petite improvement, subjective state- 




ment by patient) 


30 


One or more of the above 


S6 


No change 


3» 


Lost to follow-up for evaluation of palli- 




ation 


4 


Death between 10 and 60 days possibly 




attiibuuble to radiation 


9 



* In aoinc of the paticna tticre vai mart than one indicidon of 
iaproTemeat; thus, the perccauget exceed too per cent. 

1 3 children with Eving'i taraor iccctTcd prophylactic trcat- 
aent and are not included in ihia analjrii*. 



supply, or chemical and pharmacologic 
distribution. 

Partial body irradiation could be com- 
pared to regional isolation perfusion with 
antineoplastic drugs, again being certain to 
reach all txmior cells within the irradiated 
volume and lacking the more hazardous 
systemic effects of total body irradiation. 

The effectiveness of both methods may 
be explained by the fact that small tumor 
foci are more sensitive to treatment than 
large foci and that single cancer cells are 
more susceptible than dumps of cells. 

PSYCHOLOGIC AND PSYCHIATRIC 
EVALUATION OF PATIENTS 

A unique and important aspect of the 
research work in this project has been the 
attempt to evaluate and distinguish be- 
tween the manifestations of cancer and the 
effects of radiation therapy in regard to 
psychologic and psychiatric changes. For 
example, others have reported on personal- 
ity Xy-ptA in certain cancers,* but no studies 
were presented investigating the effects of 
treatment. 

In 1969, we reported on the effect of 



total and partial body irradiation on the 
cognitive and emotional processes of 16 
patients." This number has been increased 
to 43. These studies consisted of adminis- 
tration of a battery of tests to each patient 
in the pretrcatment phase, during sham 
and actual treatment and during a 6 week 
post-treatment period. Tests which have 
been utilized included the Halstead Bat- 
tery, Wechsler-Bellevue Adult Intelligence 
Scale, some tests of intellectual impairment 
modified from Reitan, and the 5 minute 
verbal content test of Gottschalk and 
Gleser. There has been some change in the 
several tests which we have been using 
during this phase of the total project; /.f., 
not all tests have been used continually. 

In the baseline data of 39 patients tested, 
the median intelligence quotient was 87 and 
the mean also 87. There were 4I per cent of 
subjects with I.Q. values of 95-1 16, 47 per 
cent between 71-95, and 12 per cent be- 
tween 63-70. The distribution of intelli- 
gence factors as measured by several tests is 
representative of the population served by 
the General HospitaL 

It is clear that the intensive study and 
the above testing have had a helpful effect 
in increasing the level of motivation to 
cooperate, as exhibited by all parients so 
studied. 

The need for careful handling of the 
cancer parient by all members of the medi- 
cal team is emphasized by the consistent 
evidence of depression over the 7 week 
study period. The depression is lessened 
with clinical improvement and attention to 
patient needs. It is also less in patients 
with long survival (over loo days) as would 
be expected. Similarly, hope is directly re- 
lated to survival. Anxiety dips sharply 
during sham treatment; it increases just 
prior to actual treatment, then decreases 
and levels off. Outward hostility tends to 
increase at the time of post sham treat- 
ment, then dips and remains quite stable. 
Hope as measured by the content analysis 
of verbal behavior is related to satisfactory 
human relations in the patient's life situa- 
tion. 



242 



Vol. 117, No. 3 



Whole Body Radiotherapy of Advanced Cancer 



681 



USE or AUTOLOGOUS BONE MARROW 
TRANSPLANTATION 

Because of radiation-induced hemato- 
logic depression, autologous bone marrow 
storage and reinfusion were instituted in 
1964. Employing the method of Kurnick,** 
marrow was removed from the posterior 
iliac crest under local anesthesia, to an 
average value approximating 300 cc. It was 
mixed with Osgood-glycerol medium and 
stored at —83° C. following a programmed 
temperature reduction of i" C. per minute. 
Prior to rtinfusion dextrose was added, and 
then the marrow was given intravenously, 
initially without filtration, at a rate of 50 
to 6c> cc. per minute. The first 2 patients 
•who received a marrow transfusion in our 
study, Patients 051 and 053, were infused 
with frozen marrow 24 and 19 days post 
irradiation, respectively, at a time when 
the marrow sinusoids were relatively empty 
of precursor cells, with the expectation that 
there would be more room for the trans- 
plant to take. Marrow viability in these 2 
procedures was 55 and 57 per cent." 

Patient 051 experienced moderate hemo- 
globinuria not seen in Patient 053 after 
infusion. Marrow was given in both cases 2 
to 3 weeks post irradiation; hence, it was 
impossible to distinguish spontaneous mar- 
row recovery from successful marrow auto- 
transfusion. 

Because hemoglobinuria had been noted, 
a triple filter system was developed and 
marrow autotransplantations on Patients 
070, 077, 078, 087, 090, 091, 095, 098, 099, 
107 and III have all been performed em- 
ploying this filter system." 

In marrow transplants of Patients 070, 
077, and 078, the delay between the re- 
moval of marrow and transfusion was 11, 
2 and o days, respectively. The platelet 
count of Patient 078 never fell below 
125,000 per mm.', but the white blood cell 
count dropped as low as 900, suggesting 
possible effectiveness of the technique for 
the first time. 

Fo*- the next 8 patients the technique 
was therefore modified, so that a larger 
volume of marrow (500 cc.) was removed 



from the patient under general anesthesia. 
The patient was then irradiated and the 
marrow replaced intravenously on the same 
day as it was removed. The results in Table 
VII indicate the success attendant on the 
modification of this procedure. Five pa- 
tients receiving 200 rads of whole body 
radiation showed mean white blood counts 
to be 2,820 ± 804 cells per mm.' at the nadir. 
In 7 patients given the same dose but no 
autograft, the level at the nadir was 850 
±380 cells per mm.', the 2 means being 
significantly different (Table viii). The 
first patient transplanted with our new 
technique (Patient 087) was followed in the 
Clinical Research Center, Cincinnati Chil- 
dren's Hospital, for over 6 weeks without 
any evidence of illness. Subsequently pa- 
tients receiving these whole body doses 
have only been hospitalized for a total of 5 
days or less. The degree of marrow depres- 
sion in the successfully transplanted pa- 
tient is such that hemorrhage and infection 
are not observed. 

The 3 failures in the revised transplanta- 
tion technique have been Patient 090, 099 
and 107. Patient 090 suffered a cerebro- 
vascular accident unrelated to her tumor 
or her radiotherapy. The latter 2 patients 
(099, 107) had had widespread radio- 
therapy which had affected the reticulo- 
endothelial framework necessary for stem 
cell development, and preliminary cell 
aspirates in allegedly unirradiated areas 
did appear hypocellular. Patient 107 ap- 
peared to possess normal granulocyte re- 
serves, one of our marrow screening param- 
eters, only because we were given an in- 
correctly high body weight on which to 
base our etiocholanolone dosage, thus 
falsely elevating the marrow granulocyte 
reserves. From this unfortunate experience 
we now insist that a candidate for marrow 
autotransplantation have a normal iliac 
marrow aspirate histologically, a normal 
bone marrow scan employing technetium 
99m sulfur colloid, and normal granulocyte 
reserves measured with etiocholanolone 
(after we weigh the patient) as indicators of 
normal marrow function. ,^t autopsy, Pa- 



682 



243 



Saenger el al. 
Table VII 

WHOLE EODT IRRADIATION WITH MARROW TRANSPLANTATION 



Maic*. I«7J 



Stndi 


/J 
Tru*- 
pluit 


Whok 
Bodr 

(nd*) 


Dttrof 
Mimv 
Ranored 


Ditcof 
R> 


Dttcof 

Munw 

RcioAiMd 


Naof 

Ctlb 

RdnfuMd 


VUUI- 
itT 1 


Mu- 

row 
Fmca 


CompDcstiaat 
of tnfuuoa 


Outcome of 
Autograft 


Oil 


Auto 


IJO 


«/»6/«J 


5/1/6J 


i/a/if 


l.6Xlc^ 


5J% 


Yet 


tHemogtobinttnA far I 
d»r 


Did Bot take 


OS3 


Auto 


too 


J/ 4/6$ 


j/l/6i 


Sl*l/6i 


1.4 Xio* 


57% 


Yc* 


tNooc 


Didsocuke 


070 


Auto 


150 


i/4/6$ 


3/»/67 


J/n/67 


o.j3Xio» 


6*% 


Ya 


NOBC 


Didaot CAkc 


077 


Aoio 


300 


10/31/67 


11/ 7/67 


»!/ 9/67 


O.TyXlo* 


4<% 


Yc* 


Hcmoglobiaurit far la 
boun 


OidaoctAlw 


07» 


Auto 


too 


11/ 4/67 


«»/ $/67 


!»/ J/67 


4.16X10* 


S6% 


No 


None 


PoMiblc partial take 
witk plateleta oercr be- 
lov il5,oao/min.' but 
kukoCTtct 90o/mm.» 



o«7 Iio MO 3/3/69 1/17/69 3/3/69 4 3«Xto» 99% No Nooe 



Take 



090 Auto IJO »/ 1/69 1/1/69 1/1/69 «J-6Xio» 96% No Nooe 



Ccrefaroraacular acd* 
dcat killed patient 6th 
dar after R( 



091 Auto 100 7/1/69 7/ »/69 7/1/69 4.6XI0« 9»% No Nooe 



Take 



09J Auto 100 11/ j/69 11/ j/69 11/ j/69 3.O7Xl0» 97% No No 



Take 



C9* 


Auto 


MO 


1/17/70 


1/17/70 


1/17/70 


7.4»XI0» 


93% 


No 


XraAaicot bj^poceoiioo 


Take 


e99 


Auto 


130 


3/3/70 


3/3/70 


3/3/70 


J.3IXI0* 


91% 


No 


Noiw 




No take 


107 


Auto 


MO 


ll/lj/70 


ll/lj/70 


il/ij/70 


3.iXl0» 


9J% 


No 


Nooe 




Take da«btfu|.Jeuko- 
penia but ao leptia 


III 


Auto 


MO 


j/19/71 


J/19/71 


|/l»/7l 


7-4 Xl0» 


»6% 


No 


NoM 




Take 



* See faotsoa to Tabk L 
tUofilttfcd mafio* iafuead. 



Table VIII 

RESULTS or SUCCEStrUL ISO. AND AUTOTRANSrLAirTS Or MARROW AFTER 
100 RADS MIDLINE WHOLE BODY IRRADIATION 



Study Na 



087 
091 

095 

098 

III 
Meui 
Maw of GMtrab* 



DRyofLeukoo-te 

Nadir 


Leukocyte Count Rt 
Nadir (cells/inin.*) 


16 
as 
33 
18 

3> 
18.6 

«4 


1,100 
4,100 
1,700 

1,300 

3,000 

i,8io±8o4t 
8jo±38ot 



Nucleated Cell Count 

InAued Per Kilogram 

Body Weight} 



I.6XIO" 
i.3Xio» 
0.6XI0* 
1.7X10* 
I.4XIO* 
i.jXio* 



* TpaticBti raceiTiag mo rada *kek body radialioa vitboat traaaplaatatioa of OMno*. 

tTWneuu differ ngniCcaatly by the ttcK •ip<aooiaadbrtbeWikaMntwoMOipkleMUp<aM. 

} It baa bcca estimated that I . I X lo' ccOi/kg. are rcqutred far a aacceaafcl ouiTOV iee- or aateeraiHplaac.* 



244 



Vol. 117, No. 3 



Whole Body Radiotherapy of Advanced Cancer 



683 



tient 099, who died on Day 31 post irradia- 
tion, had widespread carcinoma of the 
pancreas. Patient 107 survived her pancy- 
topenia without any evidence of sepsis. 
Patient iii had no significant cytopenia 
and her hospitalization (including auto- 
transplant) lasted only 4 days. 

This technique has been of advantage in 
simplifying the patient's course and elimi- 
nating the long period of hospitalization 
needed prior to transfusion. The possibility 
of reinfusing tumor cells in the untreated 
marrow exists, but the elimination of this 
problem awaits the development of suc- 
cessful methods of marrow allotransplanta- 
tion. 

SUMMARY 

1. Whole and/or partial body radiation 
therapy given in single doses has shown 
beneficial effects in the control of certain 
advanced cancers. The palliative effects 
compare favorably with results using anti- 
cancer drugs as commonly reported in the 
medical literature. 

Irradiation certainly seems to improve 
survival in the untreated patient with 
cancers of colon, lung and breast. 

2. The use of autologous marrow reinfu- 
sion immediately after radiation therapy 
minimizes the characteristic marrow de- 
pression otherwise observed. The degree of 
illness following infusion is greatly lessened 
and hospitalization greatly shortened. 

£ugene L. Saenger, M.D. 
Radioisotope Laboratory 
Cincinnati General Hospital 
Cindnnati, Ohio 45229 

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Collins, V. P., and Loeffler, R. K. Therapeu- 
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GorrscHALR. L. A., Kunkel, R., Wohl, T. H., 
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HicciNs, G. A., DwnoHT, R. W., Smhh, J. V., 
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HoLLCROFT, J., LoREKz, E., and Huksticer, H. 
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HoLLCRorr, J., Lorekz, E., and Mathews, M. 
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HoiLCROFT, J., and Mathews, M. Effect of 
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535- 
HoRwiTZ, H., Wright, T. L., Perry, H., and 
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615-638. 



245 



684 



Saenger et at. 



M«>rii.l«T) 



17. Jacobs, E. M., Reeves, W. J., Wood, D. A., 

PucH, R., Braukwalo, J., and Batemam, 
J. R. Treatment of cancer with weeUy intra- 
venous 5-fluorouracii. Cancer, 1971, 27, ijoi- 
1305. 

18. Jacosson-, L. O., Makks, £. K., Robson, M. J., 

Gaston-, £., and Zirue, R. E. Effect of 
spleen protection on mortality following x> 
irradiation. J. Lai. ii Clin. Med., 1949, J4, 

«S38-»543. 

19. J ACOBSON, L. O., SiMMOKS, E. L., Marks, £. K., 

and Eldredce, J. H. Recovery- fiom radiation 
injur}-. Science, 1951, 11 J, 510-511. 
aa Jaffe, B. M., Donegax, W. L., Watsok, F., 
and SpaATT, J. S. Factors influencing survival 
in patients with untreated hepatic metastases. 
SurZ; Gynec. (i Oisl., 1968, /^-, I-ll. 

31. Jen-kins, R. D. T., Rider, W. D., and Sokley, 

M. R. Ew-ing's sarcoma — trial of adjuvant 
total-body irradiation. RaJioloty, 1970, 96, 
151-155. 

32. Johnson, R. E. Ray of hope in lymphosarcoma. 

Medical World News, 1970, //, 13. 

33. Johnson, R. E. Total body irradiation of 

chronic lymphocytic leukemia: incidence and 
duration of remission. Cancer, 1970, 2§, 523- 
S30. 

34. Johnson, R. E. Total-body irradiation with 

fractionated dosage schedules. Frontiers Rod. 
Therap. U Oncol., 1 968, J, 152-162. S. Karger, 
A.G., Basel. 

35. Johnson, R. E., Foley, H. T., Swain, R. W., 

and O'Connor, G. T. Treatment of lympho- 
sarcoma with fractionated total-body irradia- 
oon. Cancer, 1967, X, 482-485. 

36. Johnson, R. E., O'Connor, G. T., and 

Levin, D. Pnmar>- management of advanced 
lymphosarcc.na with radiotherapy. Cancer, 

«970,J'5, 787-79'- 

37. Kereiares, J. G., Van de Riet, \V., Born, C, 

Ew-iNC, C, SiLBERSTEiN, E. B., and Saencer, 
E. L. Active bone-marrow dose related to 
hematological changes in whole-body and 
partial body "Co gamma radiation exposures. 
Radiology, 1972, lOJ, 651-656. 

38. KuRKicK, K. B. Autologous and isologous bone 

marrow storage and infusion in treatment of 
mydosuppression. Transfusion, 1962, i, 178- 
187. 

39. Lahiri, S. R., BoiLEAU, G., and Hall, T. C. 

Treatment of metastatic colorectal carcinoma 
with 5-fluorouracil by mouth. Cancer, 1971, 
jj, 902-906. 

30. LoEm-ER, R. K., Collins, V. P., and Hr- 

MAN, G. Comparative eflTects of total body ir- 
radiation, nitrogen mustard and triethylene- 
melamine on hematopoietic system of terminal 
cancer patients. Science, 1953, //S, 161-163. 

31. Maxheld, J. R., Jr. Use of radioactive phos- 

phonis and testosterone in treatment of 



metastatic lesions in bone from breast and 
prosute. Int. J. Appl. Rod. (£ Isotopes, 1956, 
A «33->34- 

32. Medincer, F. G., and Craver, L. F. TouI body 

irradiation with review of cases. Am J. 
Roentgenol. & Rad. Therapy, 1942 48, 
651-671. 

33. MiLBURN, L. F., O'Grady, L., and Hendkick- 

SON, F. R. Radical radiation therapy and toul 
body irradiation in treatment of Ewing's sar- 
coma. Cancer, 1968, 2i, 919-925. 

34. MvKNERji, B., Vacoda, A., Oettcen, H. F., 

and Krakoff, I. H. Cyclic chemotherapy in 
lymphoma. Cancer, 1971, 28, 886-893. 

35. Parsons, J. A., Webster, J. H., and Dowd, 

J. E. Evaluation of placebo efliect in treatment 
of radiation sickness, yfcla radiol., 1961, jd, 
129-140. 

36. Pecc, D. E. Bone Marrow Transplantati.m. 

Year Book Publishers, Inc., Chicago, I9'i6. 
pp. 102-11 2. 

37. Pestana, C, Reitemeier, R., Moertel, C. 

JvDD, E., and Dockertey, M. Natural his- 
tory of carcinoma of colon and rectum. /1m. 
J. Surg., 1964, /oS, 826-829. 

38. Rapoport, a., and Bl-rleson, R. Survival of 

patients treated with systemic fluorouraul 
for hepatic metastases. Surg., Cjnec. i£ Ohsi., 
1970,7^,773-777. 

39. Rider, \V. D.. and Hasselbacr, R. The symp- 

tomatic and hematological disturbance follow- 
ing total body radiation of 300 rad gamma-ray 
irradiation. In: International Conference on 
Guidelines to Radiological Health, published 
>s #999-RH-33, U. S. Bureau of Radiological 
Health, USPHS, Rockville, Mao'land, 1968. 
pp. 139-144- 

40. Saencer, E. L. Metabolic changes in humans 

following total body irradiation: report for 
period February, i960, through October, 1961. 
Defense Atomic Support Agency Report. 

41. Saencer, E. L. Metabolic changes in humans 

following total body irradiation: report for 
period November, 1961, through April, 1963. 
Defense Atomic Support Agency Report, 
DAS A 1 423. 

42. Saencer, £. L., Friedman, B. I., Kereiares, 

J. G., and Perry, H. Metabolic changes in 
humans following total body irradiation: re- 
port for period May, 1963, through February, 
1964. Defense Atomic Support Agency Report, 
DASA 1633. 

43. Saencer, E. L., Friedman, B. I., Kereiakes, 

J. G., and Perry, H. Metabolic changes in 
humans following total body irradiation: re- 
port for period February, i960, through May, 
1966. Defense Atomic Support Agency Re- 
port, DASA 1844. 

44. Saencer, E. L., Friedman, B. I., HoRwrra, H., 

Kereikes, J. G., and Perry, H. Meubolic 



246 



Vol. 117, No. 3 



Whole Body Radiotherapy of Advanced Cancer 



685 



changes in humans following total body ir. 
radiation: report for period May, 1966, 
through April, 1967. Defense Atomic Support 
Agency Report, DASA 2179. 

45. SaENCER, £. L., FUEOMAK, B. I., HORWITZ, H., 

and Kereiakes, J. G. Radiation effects in 
man: manifestations and therapeutic efforts: 
report for period May, 1967, through April, 
1968. Defense Atomic Support Agency Re- 
port, DASA 1168. 

46. Saencer, E. L., Silberstein, £. B., Hor- 

wrrx, H., Kereiakes, J. G., Chen, I-Wen, 
WiNCET, C, Gleser, G. C, and Kunkel, 
R. L. Radiation effects in man: manifestations 
and therapeutic efforts: report for period May, 

1968, through April, 1969. Defense Atomic 
Support Agency Report, DASA Z438. 

47. Saencer, E. L., Silberstein, E. B., Arok, 

B. S., HoRwn-z, H., Kereiakes, J. G., Chen, 
I-Wek, Wincet, C, and Gleser, G. C. Ra- 
diadon effects in man: manifestations and 
therapeutic efforts: report for period May, 

1969, through April, 1970. Defense Atomic 
Support Agency Report, DASA 2599. 

48. Saekcer, E. L., Silberstein, E. B., Arok, 

B. S., HoRwiTz, H., Kereiakes, J. G., 
Chen, I-Wen, Wincet, C, and Gleser, G. C. 
Radiation effects in man: manifestations and 
therapeutic efforts: report for period May, 



1970, through April, 1971. Defense Nuclear 
Agency (formeriy Defense Atomic Support 
Agency) Report DNA 2751 T. 

49. Samp, R. J., and Ansheld, F. J. Breast cancer 

treated with fluorouracil. JulM^., 1966, 
198, TiA-iy>. 

50. Silberstein, E. B., Chen, I-Wen, Saencer, 

E. L., and Kereiakes, J. G. Cytologic-bio- 
chemical radiation dosimeters in man. In: Bio. 
chemical Indicators of Radiation Injury in 
Man. Intern. Atomic Energy Agency, Vienna, 
I97i,pp. 181-214. 

51. Stearns, M., and Binkley, G. Palliative sur- 

gery for cancer of rectum and colon. Cancer, 
1954,7, 1016-1019. 

52. Subcommittee on Breast and Genital Cancer. 

Androgens and estrogens in treatment of dis- 
seminated mammary carcinoma — retrospec- 
tive study of 949 patients. Council on Drugs. 
J^.M.A., i960, 172, 1271-1283. 

53. Thomas, E. D., Buck.n-er, C. D., Rudolph, 

R. H., Fefer, a., Storb, R., Neiman, P., 
Bryant, J., Chard, R.,CLirr,R., Epstein, R., 
FiALKow, P., Funk, D., Giblett, E., Ler- 
NER, K., Reynolds, F., and Slighter, S. Al- 
logeneic marrow grafting for hematologic ma- 
lignancy using HL^ matched donor-recipient 
sibling pairs. Blood, 1971, jS, 267-287. 



247 




AMERICAN COLLEGE OF RADIOLOGV: M MOItTN WACKCN OMVC CMICAOO. lUmoiS MtM (11i)U«-<tn 
WASMINQTON OFnCC: MOO WISCONSm AVCNUI CHEW CHASE, MAATLANO 20011 (jai)U44M0 



JanuAzy 3, 1972 



Tha Honorable Mike Graval 

1251 New Senate Office Building 

Washington, 3. C. 

Dear Senator Gravel: 

This letter represents our response to your recuest of us to inquire into the 
whole-body radiation therapy project bein? conducted by Dr. Euqene L. Saenaer 
and his colleagues at the University of Cincinnati. We have made our inquiry 
and our broad conclusions are as follows: 

1. In the ncmal context of a clinical investication. the project is validly 
conceived, stated, executed, controlled and followed up. Ihe appropriate 
scientific and professional connittees of t.^e University of Cincinnati 
have perfomed their functions during the course of the project. 

2. The process of patient selection based upon clinical considerations conforms 
with good cedical practice. 

3. The records, publications emd patient follovup are voluminous and cccsr.endable . 

4. The procedure used for obtaining patient consent is valid, thorough and 
consistent v;ith the reccaaencations of the "ational Institutes of Health and 
with the practice of nost cancer centers. 

5. Should this project come before the Senate or one of its coamittees in soma 
fashion, we would urge your support for its continuation. 

Though physicians do not invariablv share with t-he public the ways in *S»ich 
they reach professional conclusions, we thinS it appropriate to your inquiry 
to detail belcv the way in v.hich we reached these conclusions. Our acceptance 
of your recuest v:as based upon the realization that senators have need of expert, 
ianartial nedical and scientific advice in evaluating corplex biomedical problems. 
Should you desire further inforration, we will again endeavor to be responsive. 

The i-ui -ilttee 



As I noted in my earlier letter to you, the College is seldom called upon to 
investigate the scientific efforts of any of its members and thus has no standing 
co=aittee with such a charge. Instead, I asked two leading radiation therapists 
and a third distinguished physician to undertake the inquiry. They are: 



248 



Page 2 



Dr. Henry Kaplan, chairr.an and professor of radiology at Stanford 'Jniversity 
Medical School in Palo Alto, California. Dr. Kaplan is internaticnallv kr.cvn fcr 
his pioneering work in several areas of cancer therapy. Ke has been a nerior of 
various cancer study and advisory groups including the Corriittee of Consultants 
to Conquer Cancer wr.ich recently advised the Senate. His extensive bibliocra-r.v 
includes descriptions of his work on Kodgki.n's disease i.ivolving extensive radiatic 
of patients. Dr. Kaplan is currently chaiman of our Corciission on Cancer. 

Dr. Frank R. Hendrickson, chaiman of the department of radiation therapy at 
Chicago's Presbyterian-St. Luke's Hospital. Dr. Hendrickson is also a facultv 
meciber of the University of Illinois College of Medicine and the ?ush Medical 
College as well as a consultant to the Veterans Adninistration and a r.encer of 
various national cancer bodies. His bibliography includes reports of his trsatr.sr.t 
of children afflicted with Iv;ing's sarcona with radiation. He is the present 
chairman of our Cor'jr.ission on Radiation Therapy. 

Dr. Saaiuel Taylor, III, a distinguished internist a.nd oncologist at Presbyterian- 
St. Luke's Hospital in Chicago. He is the founder of the American College of 
Physicians cancer progra.ii. He is a professor of medicine at Rush. Dr. Taylor's 
wide experience as a senior investigator in tiie field of cancer provided us with 
a view from another discipline. Ke is a long tine expert in chemotherapy of- 
disseminated cancer. 

Mr. Otha Linton, director of our '..'ashington Office, provided staff support to the 
group and coordinated their inquiry with Dr. Saenger and his colleagues. 

Mature of the incuiry 

Drs. Kaplan emd Hendrickson and Mr. Linton net with Dr. Saenqer and Dr. Charle- 
M. Barrett, director of radiation therapy at the University of Cincin.iati, ::ovor.ce.: 
29 in Chicago. The discussion covered the background of the project and the 
purposes, objectives and achievements of the effort to date. Dr. Saencer then 
provided the coraiittee with published papers and surmary m.aterials about the 
project. 

On December 16, Drs. Kaplan, Hendrickson and Taylor met in Cincinnati ••■■ith Dr. 
Saenger, other members of his team, two members of the University of Cmcir.r.ftti 
human investigation committee, and the chairman of the special university coirrr.ittes 
which was created by the president to review the project. 

Those interviewed were, from the UC Human Research Committee, Dr. Evelyn V. Hess, 
professor of medicine and Dr. Harvey C. Knowles, Jr., professor of medicine, from 
the special university coirjnittee to review the Saenger project. Dr. Raymond ?.. 
Suskind, professor or environr.>ental health and medicine, from the department of 
radiology and the study team, Drs. Charles M. Barrett, Harry Horwitz, Bernard S. 
Aron and Ed-..ard B. Silberstein, physicists, Drs. I-Wen Chen and Jeuaes G. Keriakes, 
and the psychologist, Mrs. Carolyn N. Winjet. 



249 



/» Page 3 



Dr. Saenger and everyone at the university were willing to recognize our 
competence and to cooperate fully with our inquiry. The corsaittee centers 
were extended full cooperation and cem conclude that they apprised themselves 
of the situation to the sane extent that they would have needed to do as 
menbers of an NIH study section or site review tean. Each aenber of the corL-:;itt2e 
has served in such a capacity. 

The cocciittee viewed the project as it was designed as a clinical investi'iaticr. 

of a modality for the care or cancer patients with extensive and incurable disiJES. 
Phase one investigations follow basic animal work and always precede ransc.r.iired 
clinical trials which nay or nay not be justified on the basis of the first huran 
applications. 

In the opinion of the cor-.ittee, the team at Cincinnati had abundant bases in the 
literature for undertaking its study. The participants are fully c-jalified to 
undertake the investicatioa, both from the viewpoint of good patient care ani 
importantly the possibility that new and valuable clinical inforr.ation could be 
obtained. 

Our committee did not concern itself with the implications which have been raissd 
concerning partial funding of the effort by the Department of Defense, '■■'e did 
note that DOS funds were used only to support the laboratory and psychological 
studies but not the treatment or the care of the patient. The basic costs were 
borne by the university aind its teaching hospitals. 

Because of the prevalence of cancer which has been noted so recently by the 
Senate, the House of ?.epr2sentatives and the President, those charged with Che 
care of cancer patients have need for every possible bit of information cor.cor-ir.g 
the methods and modalities which we use to treat these patients. In our oninicr., 
this project has the possibility of contributing useful clinical inforr.ation. 

It is worth noting tliat if others have had access only to the reports made to 2C0 
on its part of the project or if they sonehow failed to understand that the fart 
of exte.nsive followup in no way departed or detracted from fundamental precepts 
of good patient care, then it follows that they might reach conclusions difftrsnt 
from those of our oonaittee. 

The nature ef cancer investigations and treatnent 

In clinical investigations of cancer, we are concerned both with the basic car.cer 
process and with its manifestations in humans and specifically in the patie.--i 
who present themselves for care. The treatment of an individual represents » 
series of choices for his physicians which are based upon diagnostic findinco and 
their best judgement. Since humans respond to the assault of cancer and ;o i-ter.pt 
to treat it as uniquely as they do to most other things, generalizations heie have 
statistical value but limited application to individuals. 



250 



F&ge 4 



There are many forms of cancer. Each type has in comnon the loss of ir.trarellular 
ccntrol upon which normal cells dacend to regulate tJieir growth.. The cancers 
differ in cellular t'.ipes and in the site of origin of a prir.ary lesion within 
the body as well as the bodily pathways through which they nay spread. Thus, f'-.r 
exanple, the problea of defini.^g and treating a solid tunor nay differ radically 
from the approach to a fonf. of leukenia. 

Physicians have three funda.T.ental nodalities which nay be used singly cr conbir.=d 
to attempt to cure or control cancers. These are e.xtirpative surger-/, high energy 
radiation and chemicals. Horrones also are used to atter-.pt to alter the course 
of certain cancers involving the endocrine system. 

The choice of treatment must be decided for each patient. The decision is based 
upon the type of cancer, its location, its size, its degree of spread and upon 
the age and general health of the patient. Ideally, the therap-sutic decision is 
r^de in a cancer conference involving physicians fron the different disciplines 
appropriate to the problen at hand. Sy t-he nature of tiia disease, any cancer 
therapy trust be regarded as heroic. The cancer patient nust accept lesser 
probabilities of success and r.ore stringent side effects of treatr.ent t-han usually 
befall sufferers fron other diseases. 

Timing is all important in the treatment of most cancers. A small, eeirly cancer 
may be removed surgically or destroyed with radiation. But if the cancer has 
begun to spread beyond its original site and beyond the surgical or radiation 
field, the destruction of the primary lesion will not suffice to save the patient. 

Unfortunately, many patients still are diagnosed as having far advanced cancer 
which xust be judged unlikely to respond to any standard curative effort. These 
patients nay have undergone various treatr.ents without success. Cr they may have 
had a "silent" priaary cancer which was diagnosed only after it began to spreai 
through the body. 

The physician having the care of a patient with advanced cancer has three practidl 
choices. One is to do nothing, allowing the disease to take its course. Another 
is to attempt palliation, an effort to retard t.he tusior growth and/or to ease r>,e 
pain of the patient. The t-hird is to attempt drastic or radical treatr-.ants r.ot 
commonly accepted as reliable or efficacious for patients having a greater char. :i 
of success. The third approach carries t.he long-shot possibility of direct pat;-;.-.: 
gain. The doctor and patient r.ust agree that something of benefit to others riy 
be learned froa the effort. 

Thus, the effort to improve cancer treatrients has been based upon the first 
application of new or questionable techniques to those patients having nothir.c 
to lose by their failure because there is no known treatment available. Ofte.-'., 
the effectiveness of the technique must be measured in tine of survival, relic: i.i 
pain, or from certain body measurements, rather than in terms of overt tumor 
destruction. Efforts must be made to isolate and measure the specific tiirinc, 
dosages, procedures and restraints which can be observed to alter the course '.:' 
the disease. '.Jhen a form of treatment has been shown to have some measurable 
beneficial effect on far adv2mced oatients it can be considered for general use. 



251 



Page S 



The nature of cancer investigation requires that nore than one therapist r.u;;t 
undertake a new nodality at each stage cf its development before it can be accapte 
for general usage. If an incrovemcn^ in sciie tool or resource becones a/ailable, 
such as the advent of supervoltage radiation sources then previous studies r.ay 
be repeated with profit. 

Both the high energy radiation and the several chemicals now used in cancer therep-.. 
have hamful effacts upon patients. So does radical surgery. The choice rust be 
made to refrain frcn curative efforts when the destruction of the tunor -A-ould 
involve unacceptable side effects of a localized or systemic nature. Thus, effortr 
to control or relieve side effects are equally significant with those to destroy 
the tunor . 

VvTien radiation is used as the tur.oricidal agent, the effort is nade to linit its 
effects by tailoring the dose to the suspect aria and by using a series of tolerabi. 
exposures to destroy the cancer cells without da.-aging vital organs and adjacent 
nomal tissues. If a cancer is widespread, then .^ tunoricidal dose of radiation 
presents probler.s which, for the r-.ost part, remain unsolved. Lesser aiounts of 
radiation have been used in various ways as part of efforts to retard tumor growth, 
to relieve pain or to alter the pattern of cancer development. 

The literature of radiation therapy offers substantial nimbers of citations of 
efforts to use whole or partial body radiation for the palliation of advanced 
cancers. The conclusion, broadly, must be that the concept has not been sufficient 
productive to reccnnend generally nor so lacking in effect to be abandoned as an 
approach. 

The Cincinnati project 

The actual treatr.ent of patients was begun in 1960 by Dr. Saenger and his colleanuf-; 
as a clinical assessnent of the use of sublethal whole body radiation for the 
palliation of patients with a variety of disseminated cancers. T.ie prer.ise -as 
that the level of radiation selected would have a retardant effect upon the crc/th 
cf the tunor cells throughout the body and that the patient, for the nost part, 
could tolerate the side effects of systenic radiation. 

The second part of the preciise was that patients who were closely followed after 
their cancer treatments could indicate both the physical and psychological roactio.-..- 
to the therapeutic effort over a period of several weeks. This clinical assessrant 
provided a new dimension to previous studies of the use of whole body radiation. 

Beginning in 1964, the group began to use the technique of autologous bone -am-* 
transplants as a means of overcoming the marrow depression otherwise inescapible 
after' whole body radiation. The technique after some modification involves t;;e 
extraction of 300 to 600 cubic centimeters (about a pint or so) of marrow fror.i 
the posterior iliac crest just before the radiation exposure. The same day, the 
marrow is filtered and reinjected into the patient. As a clinical procedure, this 
has succeeded in averting most of the extended radiation syndrome effects pre vicus 
observed in patients in this series and in other -^hola body studies. 



252 



JSa.<3^ 6 



Efforts to mininise late effects, such as the drop in w'.-.ite cells and platelets 
and the decrease in ted blood cells which ara classic to radiation syndrc--?.s, began 
in 1965. This method using autologous bone marrow irCTediately after radiation 
therapy, became practical early in 1969. 

The concept of whole body radiation as a method of treatin? cancer is not n^v 
with the Cincinnati project.' There is voluninous literature reporting ccn;rcll;d 
euiinal experir.ents which are hishly useful but not indicative of hur^ar. responses 
to human tur.ors . The literature reporting on hunan exposures dates bar:< to 
efforts in 1923. A review of reports to 1942 showed more than 270 patients thuj 
treated with fairly little encourager:'.ent. Since these patients in all cases had 
disseminated tu.-?ors and the radiation sources available were in the ortiiovoltaie 
range, the results were not surprising. 

The advent of supervoltage generators and particularly cobalt 60 sources pro-ptcd 
additional studies to assess the effect of higher energy radiation and led tj a 
new round of studies. In 1953, V. P. Collins and R. K. Loeffler crlled the I'.se 
of 200 roentgens whole body "a useful addition to the nanagement of advanced cancer. 

A current bibliography contains some 86 scientific articles on the subject, 
excluding Dr. Saenger's contributions, t-.'hole body projects have been undertaken 
in more than 42 U. S. medical centers. At present, efforts are under%'ay using' 
whole or partial body radiation for the control of leukenia, Hodgkin's disease, 
polycythemia vera, multiple myeloma, and disseminated cancers of the breast, 
thyroid and prostate. In verj' small croups, whole body radiation has been used 
successfully in curative efforts against Ewing's sarcoma, a bone tunor primarily 
of children. 

The Cincinnati' study through the end of 1970 involved a total of 106 patients 
referred from the Tumor Clinic of the Cincinnati C-enerai Hospital. These were 
patients found by biopsy and clinical exa-mination to have disseminated tumors. 
They "were chosen because they suffered from advanced and widespread neoplastic 
disease such that cure could not be anticipated," in Dr. Saenger's words. 

All of the patients underwent a 7 to 14 day assessment period to reaffirm the 
diagnosis and to determine \v-hether their disease and their general health woula 
usake the radiation attempt feasible. Some 24 patients were rejected and received 
no radiation on the basis of their clinical assessment. Some of the 82 patients 
later treated received sham radiation sessions during the assessment period but 
none actually were exposed until after a decision by the team which determined 
the txeatmente. could be beneficial. 

The patients had a variety of tamors. The largest group was 25 with cancers 
originating in the colon and rectum. A second group of 14 had tur.crs of the 
broncijus. Fifteen women had disseminated breast cancer. There were 23 patients 
with miscellaneous tu.-aors. Three children had Ewing's sarcoma and were treated 
for curative effect. One of the 25 patients with miscellaneous tumors had Swing's 
sarcoma with metastases too widespread for a curative effort. 



253 



Page 7 



Discussions with the patients and nembers of their families are standard in a:iy 
cancer therapy situation and «ere a part of this project from its beginning. 
Specific patient consent forms have been'used since 1965, when this step was 
recommended by the National Institutes of Health. 

Since 1953, patients selected for the study were iriter\'iewed on succeeding days 
by the internist in the project before being asked to sign a consent fom for the 
therapy. "Tien possible and in all cases of children, the interview included one 
or more nerbers of the farnily v;ho also consented to the treatment. Except for 
the three children with Swing's sarcona, all -.'ere told that their cancers had 
been defined as incurable and that the treatnent would be attempted in an effort 
to prolong their lives and possibly to retard or shrink the tu-T.ors. They were 
told that the infomation gained from the study was hoped to be helpful to other 
patients. In the last few years they were told that the information might have 
military as well as clinical significance. 

The patients were told that there could be son" side effects from the radiation 
exposure and that the team would wish to keep in close touch with then for a 
period of v.-eeks to study their reactions both to the advances in their disease 
and to the ir.pact of the radiation. The possible side effects were not described 
in detail nor emphasized to avoid subjective inducement of the symptoms. 

So far as the side effects were concerned, the team reported that 45 percent had 
no vomiting or nausea after the radiation. Bene 24 percent experience "^ transient 
vomiting and nausea within three hours and another 17 percent had the sesr-o syr.ptor.s 
within 12 hours of exposure. Anot-her 9 percent continued voaiting up to 24 hours. 
Only five percent had prolonged and severe vomiting and nausea. 

It is worth noting that these symptoms eire certainly no greater than those 
experienced by patients treated either by surgery or by any of the systemic drugs 
now being used clinically on disseminated cancers. 

The patients v;ere selected by clinicians at the Cincinnati General Hospital from 
the population served by that institution solely on the basis of their tunor 
diagnosis. Since CGH is a institution, none of the patient- were private patients. 
The three children with Swing's sarcoma were referred by physicians at the affiliat 
Cinainnati Children's Hospital. 

Extensive psychological studies were done on 39 patients. It was possible to 
establish their IQs. The median on the studied grcup was 87. The range vas from 
116 to a low of 63. Some 31 of the treated patients were caucasiein and 51 were 
negro. In both race and IQ the group was representative of the patients served 
by CGH. 

The three children who were treated dufinitively for Ewing's sarcoma remained alive 
from one to four years after treat.-:ient. From the other 79, for whom only palliatic 
was expected, five others survived as of October of 1971, the longest by more 
than six years. 



254 



Page 8 



The clinical assessnent of tha effort indicated that (vith overlapping percjntzo?-;) 
29 percent felt relief of nain, 30 percent shoved a measurable decrease in criTsrv 
tumor size, 11 percent reported an increase in activity on tneir ovn part 
following treatr.ent and 29 percent reported an increase in "well-being." ;icut 
29 percent shoved no evidence of inprovenent or change. Four percent were lose 
to follov.-jp. A group of 10 percent or eight patients cied fron 20 to 60 days 
after the vhole body exposure. 

It is not possible to determine positively that those patients who died within 
60 days of the treatment v.'ould not have succumbed to their disease within thit 
period, even tho-gh the clinical assessnent had been triat their disease was 
stable enough co justify their inclusion in the study. However, it was noted fro:-, 
the follow-.;? studies that their bone marrow function was subnormal and thus 
relatable to radiaticn syndro.me. 

In terms of survival, the Cincinnati group reported re.'sults showing an extension 
of days over untreated patients in each of t.he tu.r.or categories. Kowever, results 
were not markedly superior to the survival results reported by ot!>er investigators 
using various chemicals or other combinations. 

The survival figures are clouded by the fact that many of the patients included 
in the sa.-iple had already undergone one or more types of treatment unsuccessfully, 
often only a short time before their i.-.clusion in the study. Some of the patier.ts ; 
the study also received extensive followup treatment, sometimes involving further 
radiation of <Lhe primary tur-or area. 

Thus, the patients received a therapeutic regimen which was clinically judjec mcst 
efficacious for their survival and palliation, hcwever much the added efforts 
blurred the observation of the effects of the single whole body exposure. 

In specific terms of survival. Dr. Saenger was able to draw rough cor.parisonc 
which indicated the benefit of some treatment over none. He found that liis 
results compared to those gained by other investigators using surgical resect-^ns, 
drugs such as 5-fluorouracil and, for the breast cancer patients, estrogens ar.d 
androgens . 

In Dr. Saenger's words, "The relatively small nu.~i)ers of patients in these grcucs 
(his emd the ones compared from the literature) preclude any claim to therapeutic 
superiority. On the other hand, it seems reasonable to continue therapy for -r.?se 
gravely ill individuals since this method of treatment is less elaborate and with 
no greater risk than many present forms of chemotherapy." 

In this conclusion, the ACR committee would concur. The committee would also 
observe that the protocols, reviews by appropriate institutional authorities. 
attention to patient interests and resconsibilities and reporting are all ccnsistsr.t 
ifith accepted good clinical and scientific practice. 



255 



Page 9 



Responses to Senator Gravel's questions 

Some of the points raised in the questior.s in your letter of Moverier 10 ar2 
covered at least in general aisove. Sor.3 are not. Hence, the questions £nd 
specific responses are detailed below. 

1. ANIMAL DATA: Don't experimental animal trials as a rule crsceda hu-ar. 
trlals in the testing of nev; r'edical therapies and drugs? '..liat ar.irsl 
trials using partial or v.hcle-bodv irradiation to treat cancer •••ere 
completed before Cr. Saenger began his hunan experir.entation? Did ;r. 
Saenger begin his special "therapy" before or after Defense Depart.-=r.- 
support? 

ANSV-XR: The literature on radiation biology is substantial v/ith regard to ar.i-al 
trials of whole body radiation for a variety of purposes. One bibliography is 
appended. Almost alwavs, clinical researchers have had the benefit of aniral -..ork 
to test the toxicity of their materials and to develop general patterns of 
biological response. Hovever, since inter-species differences never allow the 
total transfer of animal data to human usage, it is necessary to u-ndertaJce 
clinical trials under proper conditions ".lo test any new therapy or agent. It 
is not necessary for a clinical researcher himself to undertake euiinal work if 
he has access to and a good understanding of the literature on the subject. This 
was the case of Dr. Saenger and his colleagues. 

As an example of the application of animal studies to human uses, the use of 
autolocou-5 bone marrow transplants ar.d the basic understanding of the inflJir.c; 
of marrov stem cells on mar.-malian survival after '.'hole body radiation ex-cs-rc 
were wor/.ed out m animal experiments. The marrow transplants are a rost 
important part of the Cincinnati investigation. The detailed biochemistry r.:; 
only permits a more complete analysis of the response of these patients but il=; 
could point the v.-ay to other researchers who are attempting systemic therapy 
with radiation and with investigative chemicals. 

It was a necessary part of the clinical investigation for Dr. Saenger to detemr.e 
the optimal ainount of narrow to extract, t-he most effective way to handle it ?r. ; 
the best timing for its reinjecticn into the patient. At the beginning of :'-.:.: 
work. Dr. Saenger and his vrsuo extracted thi marrow and froze it to retain .•. ::r 
the 18 to 21 days during which blood vhite and red cell levels are expected •. : 
decline. Hlth- subsequent patients, they determined that the prompt rein^ect-.rn 
of the marrow the same day the radiation was administered averted much of the 
blood depleting effect of the radiation. 

Since Dr. Saenger in this instance applied to the Department of Defense, r?'.- r 
tham another funding agency. Cor the su-port for the extensive biochemical ■ :r .-.z 
which would provide the "nev;" element cf informaticn from the survey, his 
preparations preceded the 1950 data at v.hich the actual project was funded 
oy COD and patiant treatment began. As noted, the support for the patient 
treatment and management was provided by the University of Cincinnati and it? 
hospitals. The DOD funds v.-ere applied only to the biochemistry and subsccue -.-.:•.• 
the psychological testing v+iich a"llo-.;cd a more complete assessm.ent of the et:i:-.. 



256 



Page 10 



3. POLLOWUP STJDIES: Kow dees Dr. Saenger foUcv up his own patients to 
find out if his "treatnent" has been helpful or haraful to" then? Does 
ha measure the tumors he hoped to reduce, for instance? 

ANS'.^R: As noted, the followup on these patients is consider sbly more coapletj 
than is possible for most tunor clinics. The followup consisted of clinical 
observations emd di.igrostic studies emd frequent doctor-patient contacts between 
both the internists and the radiation therapists on the tean with the patients 
who had been treated. In addition, the tean psychologist riaintainsd contact, not 
only for her tists but also as a further supportive measure. 

The data on biochemical responses and upon psychological reactions is valualile 
but siraply too sxrensive in terns of manpower and Isiboratory facilities to be 
possible for overy cancer patient, even in the best of cancer centers. 

The assessment of results was made by clinical observations of the patient which 
indicate the elenents of well-being and systemic function plus laboratory analyses 
of blood condition and voiding functions plus x-ray diagnosis to check the 
size and penetration of solid tumors. In many of the patients, the priJMiry tumor 
had been excised surgically or treated previously with a prophylactic dose of 
radiation, leaving nar.ager-.ent of the metastases as the r.ajor clinical concern. It 
is worth noting t.'iat only 4 percent of the 82 patients in the 10-year series were 
lost to conpletc followup. A detailed report on these results is cited in the 
preceding section. 

3. CONTFOL G?CUPSt tfhat control groups, does Dr. Saenger have, or has he 
iurrangcd for at our great cancer research Institutes, so that he can 
detennine how his special "treatment" is working? 

AMS^'^R: The question of specific control groups and randomized saaiples does not 
usually arise until after the completion and evaluation of the type of study 
currently undcr-vay by Dr. Saenger. He advises that planning for a more elacorate 
phase three study began last June on the basis of assessment of the 10-year result? 
of the present effort. 

The literature contains sufficient studies of similar patients and comparable 
sized samples treated by other methods to allow basic comparisons of tumor 
regression, post- treatment symptoms and survival, times after palliation. 

Again, it Is worth noting that the extent of preparations and followup on each 
patient and the njmbcr of cancer patients at CGH who are suitable for an aggressive 
palliation study have conbined to limit the size of the group under investi=£.tion. 
A phase three study appears, feasible at Cincinnati but will require a substantial 
comaitjsent of staffing and financing from some source ether than patient care funds . 

4. PRIVATE PATIENTS: Does Dr. Saenger treat an? private cancer patients, cr 
offer consultation on private cases? Does he rscozmend or use his partial 
or whole-body radiation "therapy" on paying patients? Does he know any 
doctor who does? 



257 



Page 11 



nNSfilER: Dr. Saenger and his colleagues are full-tir.e faculty merJbers of the 
University of Cincinnati College of V.edicine and have ro private practice in the 
ordinary sense. Thair patient care responsibilities are restricted to patients 
at the city-operated Cincinnati General Hospital and i-s affiliated institutions. 
A very few patients vere referred to the group frcni doctors at the Holr-.es Hospital, 
a privata practice institution affiliated with the university. Hov;ever, those 
patients vera rot charged for the treatment and n-.edicai care involved in t-heir 
participation in the study. 

At this point. Or. Saenger does not use his treatrent en "paying patients" 
because he has none. He dees not recomend his technique to other physicians 
because the investigation is not yet conplete and t.he results are not iniicative 
of ir-eiiite application to clinical situations apart fron a research effort. 
Dr. Safin'jer would encourage other qualified researchers to duplicate his project 
or to rodify his techniques on the basis that results to date are sufficiently 
promising to warrant further investigation both by his group and by others. 

As noted above, sone type of partial or whole body radiation is used in nore 
than 42 different U. S. nedical canters. A total list of these is not available, 
but they do include both public institutions like the University of Cincinnati 
and private cnes vhere nest patients are charged for their care and treatment. 
Thus, it is likely that instances could be found in which patients did pay for 
this treac-ent approach. However, the scientific literature does not ordinarily 
cite the question cf patient payr.ant in reporting on clinical research. The ACP. 
ccnanittee was not in a position to nake any extended inquiry on this point. 

5. TRICKERY: Is there any trickery of the patients involved? 

a.) Do the patients really understand the exceriirant is largely to 
help the Defense Departnent prepare for nuclear warfare? 

b.) Do you consider the release the patients sign to be sufficient 
evidence that they understand? 

c.) Do the patients understand that the experiment may cause them 
severe discoafort, such as hours of vomiting? 

.d.) Do the patients understand that partial or whole-body irradiation 
may shorten their lives, and if so, by how much? 

e.) Do the patients understand whether or not there exists any basis 
for suggesting that the "treatnent" may reduce the size of their 
ttznors or reduce their pain (as Dr. Saenger suggests in the 
Washington Post , Oct. 8, 1971)? 

The question of informed consent was investigated extensively by the ACR coirrittea. 
The University of Cincinnati Ccrjaittee tor Hunam Investigation was forr,ed in 
1965, as it was in most other institutions, and has had a parallel development 
under the guidelines of the National Institutes of Health. Their consent foms 
have been gradually modified over t-he years and the sophistication of their review 
has increased in a parallel fashion. 



258 



?aga U 



It is the opinion of the ACX ccanittee that at the present tine and through the 
years the OC comittee has runctior.ed effectively and ccr.parably to sinilar 
connittees at any of tlie other leading instituticrs which conduct cancer research. 
It is likely that the UC c<)nnittee has perfors2d its function better than the 
average group because of the volume of projects generated by the medical faculty 
«nd the professional ccacetence of the people involved. 

The current consent seeking procedure was reviewed by the ACR comsittee. The 
tean internist (Dr. Silbsrstain) interviews patients t-.<o tines at least 24 hours 
apart and discusses in sxtonsive citail the procedures that will be undertaken. 
This is dor.2 not only for the patient but also for neriers of his far-.ily, when 
available. Tie specific ar.i detailed consent fcms are not presented tc tha patier.- 
until the cc."letion of the second inter-ziew. The fora in use is modified for 
specificity frorx the basic ones prepared by the ::ational Institutes of Health. 

Except in the case of the three children with Swing's sarcona who were treated 
curativelyr the patients knew before being referred to the study team that 
they had malignant disease for which no curative treatnent is possible. They 
knew that the efforts of the study teaa were not offered as curative/ 

"any patients expressed a desire to participate in the study and possibly to 
help the plight of other cancer patients in the future. The docxrnented psychologici 
studies which were incorporated in the project beginning in 1965 give the study 
group core than the usual assurance that their explanations and the required £orc.s 
were understood by the patients and by their fazdlies. , 

The ACS coanittae felt that the patients were adequately informed about the nature 
of the proposed therapy and a'oout the consequences. As noted above, the patients 
were not inforr.ed in detail about the side effects of radiation because of the 
psychologicid. influence of expectation involved in both nausea and voniting. .'Vs 
tcentioned in the project narrative, about half of the patients did not sxperieiict 
unpleasant side effects and aost of the others had only transient syr^ptons. It 
should also be noted that since r.ost of the patients had undergone previ'.ius cancer 
treatments, often involving radiation or syster-.ic chesiicals, they were aware fron 
previous experience of the types of sequellae which might be encountered. 

The patients ware advised that the project was designed in the hope that the 
radiation would relieve the pain of their cancer, that it night shrink the 
size of the prlnary turner or retard the develcpr^nt of netastases. N'o guarantees 
of any of those results were offered. 

In tha ACR committee's view, the assertion in question 5 a. that the experiner.t 
"Is largely to help the Defense Decartaent prepars for nucleaur warfare* is net 
correct. This is not tho eriiaary purpose of the effort and to have advised the 
patients to that effect would have been oisleadlng. 



259 



Page 13 



The patients were not scecifically informed that the partial support came from 
DOO any more than other patients in other studies at Cincinnati or elsevhere 
are advised of the specific agency support of projects in -vhich they are involvad. 
The Cincinnati patients were told that support case in part fron a national agar.c\'. 

At the tine the patients were counseled prior to the request- for execution cf the 
inferred consent fom, they were advised that the possible findings r^y have r.ore 
than clinical inplicitions and could be helpful to persons receiving whole body 
radiation in industrial accidents, military activitiss or as fallout froa a 
nuclear detonation. 

The question of the source of support for a project is not construed by the AC?, 
coannittee or by nost r.edical investigators as being relevant to the issue of 
inforrr-ed consent. In this case, the DOO exercised no control over patient selecticr 
or clinical treatment ar.d indeed did not require descriptions of that part of the 
project been directed prinarily to-vard the assessnent of whole body effects of 
radiation rather than the nanagenent of disseninated cancer by radiation, the study 
group could not have incorporated the autologous marrow transplants which so 
drastically altered the classic radiation response. 

Though this letter has extended to substantial length, it obviously represents 
a sursriary of the facts of the Cincinnati study and a precis of the opinions 6f the 
College's comittee ner-bers on that study and on the basic issues of cancer 
investigation in hur.ans. As we indicated at the beginning of the letter, we would 
be happy to attanot further discussion of euiy point on which you may still have 
concern. 

Sincerely, 



Robert K. rtcConnell, M. D. 

President 

Americem College cf Radiology 




260 



' OOMPTROUJER OCKSnAL Of TKS UMTTCD GTATtX 
W««MINOTO>*,OuK MS4* 

'WY 2 G 5372 
B-164031(2) 

Dear Mr. Chairman: 

Pursuant to your request of December 23, 1971, and dis- 
cussions with your office, we obtained docunents relating to 
(1) the whole-body irradiation program at the University of 
Cincinnati Medical Center and (2) the policy of the Depart- 
ncnt of Defense on the subject of the protection of huinans 
used in medical research projects under contract. The en- 
closure to this letter identifies the docunents obtained by 
us and made available to your office during our work. 

Concerning the policy on the subject of the protection 
of hinans used in medical research projects, an official or 
tlie Dep&rtRent advised us that' the policy of the Departnent 
was set forth in Departnent of Defense Instruction S030.29, 
dated Hoy 12, 19C4. The instruction, which is applicable to 
all coiaponents of the Departnent and to its contractors or 
"grantees, states that: 

• "The Department of Defense assuncs full responsi- 
bility for the protection of hurasns involved in 
research under its sponsorship whether tliis involves, 
investigational drugs or other hazards. 

"Hach Military Departnent will establish within the 
office of its Surgeon General a forr.al Ueview Board 
of professional ocrscnnel to consider cecli research 
proposal fron within that Military Departnent or 
fron its contractors or grantees vhicii cay involve 
the use of hunan subjects in the clinical investiga- 
tion of new drugs. Before a clinical test with an 
investigational drug nay be performed imder the 
sponsorship of a Military Dcpartnent-- 

••1, the plan of the test and other pertinent 
details Must be submitted to the appropri- 
ate Review Doard, 

"2. the Board nust indicate its approval, and 

"3. the approval r,ust be confirncd by the re- 
spective Surgeon General." 



261 

B-164031(2) 



With the exception of certain reports that vere required 
to be filed vith the Food and Drug Ad4'ninistration of the Uo- 
partment of Health, Education, and V.'elfare in the case of in- 
vestigational new drugs, no procedures were specified in the 
instruction with regard to the use of human subjects for other 
research purposes. The reports to be filed with the Food and 
Drug Administration vere set forth in a Menorandun of Under- 
standing bctKeen the Department of Health, Education, and 
Welfare and the Depart!?.ent of Defense, dated February 1964, 
which contained the procedures to be followed to ensure that 
the requirenents of the Federal Food, Drug, and Coscetic Act, 
as amended (21 U.S.C. 355), and the regulations issued under 
the act are fully net. 

Although the instruction appeared to be directed pri- 
marily toward the investigational use of drugs, an official 
of the DcpartEcnt of Defense advised us that tlie instruction 
applied to all nodical research projects. He stated also that 
each service directed its ov;n research projects without con- 
trol from the Departnent. 

We contacted officials of the Departnents of the Aray, 
JJavy, and Air Force and of the Defense Nuclear Agency, for- 
nerly 3;nown as the- Defense Atonic Support Agency (the organi- 
zational entity within the Department of DefcT^se that had 
contracts with the University of Cincinnati relating to the 
whole-body irradiation prograr.) , to detcminc whether tliey hod 
any instructions or regulations that v/cre applicable to the 
use of humans in ncdical research \.'ork under contract. The 
officials were not aware of any instructions or regulations, 
other than the instructions znd regulations i-plementing In- 
struction 5050.25, involving the use of huc.aji subjects that 
would apply to contractors conducting nedical research for 
their organizations. - ■ 

An official of the Departnent of the Air Force advised 
us that the Air Force did not conduct nedical research u:ider 
contract. Officials of the Departne-its of t)ie Amy and Kavy 
stated that, alt)iough nost nedical research had been conducted 
in-liouse, sone had ijcen perforr-cd under contr;iCt. They stated 
also that, when work is to be performed under contract, they 
. nust be satisfied that patient consent forr.s will be used ?Jid 
that human subjects v.'ill be adequately protected before a con- 
tract is executed. 



262 

B-164031(2) 



*!. * An official of the Defense Nuclear Agency advised us 
that, although the Defense Nuclear Agency did not have any 
contracts for the use of luinan subjects for medical research, 

!!^L5 ?*^"^.^''"^'°?^'.^^^ ^°*" included in all medical con- 
tracts after August 1971. 

1. ,,"I^®.^9^ [Contracting Officer's Ucpresentativel 
shall be informed in writing of any project plans on 
the part of the Contractor to cnploy new, experir.en- 
tal, and investigational drugs or other hazards in 
research involving hunan subjects, and such exiJeri- 
nientation shall be specifically authorized by the 
Contracting Officer in writing prior to the prosecu- 
tion of such research. Without the concurrence and 
authorization by the Contracting Officer for th- 
specified drug or other hazard involved, such re- 
search shall not be performed. (The Durpose of this 
Clause is to insure conpliance with the Denartnent 
of Defense Instruction, 5030.29, 1964 Hay 12, en- 
ttH? 'Investigational Use of Drugs or Other Hazards 
by the Departnent of Defense', a copy of '.;hich is 
furnished to the Contractor with this Contract)." 

„.^. Concerning the contract with the University of Cincinnati » 

?55to.'-^^ f ^^^° "''^°^^° ""^^^^^ '''^'^'^^y 5^^^"=^ that the cosrof 
radiation t.rsat::cnt and patient care had not been borne by 
their agency. Tlicy stated also that funds of the Defc-".- 

l^Si^^L^^''"*'^'.^''*^ ^''^" ''"'^ ^"^y ^° P^y for supDler.£:ntar7 
,-S~^?J^^ analyses of patients Kho had received" vhole-body 
irradiation in order for the Defense Kuclear Aijeccy to -ain 
information m areas that were relative to national defense. . 

unio.^^Fi^'' *° "°''^ no further distribution of this rcuort 

m"Je di^JJ^Knt?'"''' SP^^^^I"!!)' requested, and then'we shall ■ 

Sr nublfc innnf,^!? ""H' k''^-^ y^""" lErccment has been obtained 
or public announcencnt has oeen nade by you concerning the 



263 



B-164031(2) 



contents of the report. Ke trust thc?c corunents will serve 
the purpose of your inquiry. 

Sincerely yours. 



^ 






/A^ii^ 



-\ 

Conptroller General 
of the United States 






Enclosure 



The Honorable Edward M. Kennedy 
Chnirnsn, SubccTTjnittee on Health 
Coraraivtee on Labor and Public VJelfare 
United States Senate 



264 

Dccci^>cr 9, 1974 



Bocorxble Saa Ihinn 
UniCRd States Senate 
I7«£hlnst(m, D.C. 20S10 

Pesr Senator Ihtnn: 

Th£rk YOU £or yoar notes o£ ITovt>itber 20, 1974, cddre&sed to t^te Dcpartaent 
of ITcalla, Educatlca, lad Welfare *rd to the Dcpartsjcnt of i>ofcnse, Rnclcsinp, 
Hra. Llcyd B. Vilfords Icttcre of J."oveaJicr 7 «cd, pftrcicularly, for 
Dr. B. Fetcr tJcti^cr't; tii^-ily Intccurete column froti t'le /tlrnta Journal . 

The r^i^ul&tory issu-ince described by Doctor IJetzper cs soaistMnr. * . . . the 
U.S. Ccf-Erl-ncnt of ii-Jiltn, Edacictoa, au<t .^'cltarc (H!:..*) , t-ts filially cowj 
tip with . . . .' ere r-roposcd iy74 c.xer.iiujcnte to csJctl'.?, 19/3 re^^uletior.s 
vhlch 111 turn codified k 1S71 Jtoartaxiatal roHcy woich 3ro^ out of o 
futile Health £e.i\/ice policy ditin*; beck to 1966 end rrrlier yrr<rs. Thccs 
pre-exietln:; policies reflected cbc 05=c co.ceros rclt^d In U.>ctor ffet-.-.cr 's 
ertielc. K.'e arc enclosing; f^e rolev.'«nt Isc-ucnces iiod t'ao lactlcuilonbl 
Guide . . .'to t'.tis policy w'llcn touch on cxny of these ie&ucs, Yoyr 
attention is spcclficallv called to tU& rec.uircaent that ell of our ;:r3ritces 
sdo;>t their o~m ooral and ciiilcil codes to puldo their research, and to t;ic 
loss Hot of aiicU cades oa ttie Ipct rc;;r3 of the Guide. Oitr p.rAntft end 
contrects support research in a uide spectrua of religious cod secularly 
coQtrollcd sclecclfic ioetitutions. 

The colvtcQ by Doctor Hetrp.er dvrells at sou:e length ov. &n alleged ebusc 
of rc»c«reh procedures at the University of Cincinniiti "^ctveen 1&50 nnd 
1971. Cdctor 13et£;;er does not taintion th.-c an Invcstivaclor ^y tee Csncrel 
/«countir.s Office foiled to dicciose cny sutistentive ^sscciftion betveen 
Cepcrtcxnt of U;clt.'), EducAtion. cod Welfare &nd Dcpnrtsa&t of Defease 
research Activities at this institution «i d tUe ccso-byccse trcatr«ne of 
the Cincirnnct patients. Vie I'aiversity never accepted i5efen?e fuudo to 
*zAp" pstlOQCS. Txo patients verc crested individually for the diseases 
th«7 had* 

Vhole-body radiation ac levels of a few hundred rads is lethal only when 
it destroys the blood building cells of the bone ra£rro</. In cbc treotiaeoC 
e£ these patients who had widespread tsetastatic cancer, a ler{;e part of 
the narrow was first rcsoved, the patient vas then trestcd *nd the osrrotf 
ceturoed. Bou* of the patients Ir^volved died Croia radiatioa sicknesa. 



265 



P«£0 2 - Uonorftble Jua Kunn 

th9v«h rvo of thcQ did die with unusually Ici^ white blood cell counts. 

In all Instances, donth was clearly ettrlbutablo to cho adveoce of cancer, 

or to Intcreurrcoc dleesse Associated vlth cdvsnced cenccr. 

The lact p2ra<;raph of Doctor >fet«scr'« article contain* the basic error— 
thct tbe patlente were Sclnj: gtvc.i tf!:olc-body radlAkloo for ic«>?J.l.^d 
CAscer. llothlrg could be farther froa the creth. All of tbe p«cicnta bed 
hiid prlor-'Ond ur.succcssrul--sursery for Iccaliced cnccer, nost of thca had 
had cddltloufsl surgery or localised radiation, all by no^^ had vldespreed 
secastases sxking further surgery or loccll^ed rcdladon ineffcetlvo. 

Doctor Mstif.er falle to note the flndlrp. by the A-^rlcsn College of Rcdloloay 
tbat this treataieat vas flt least cr. effective es druc thcrany for certain 
types of c«r;c<*r "^nJ, In the cjse of Bvlng's c=rcocia, c clill.i!iood bono cancer, 
appeared to be far superior co any other treatsumt chec avcilsble. 

Sincerely yours. 



D. T. C;alkley. Ph.D. 
Chief, Office for IVotcctlon 
fro:-) J'.er.carch ili^ts 
Office of the Director 



3 Enclcsarea 

H-y 30, 197-5, Fi^dcral P.c? let or 
AusuPt 23, 197'i, i'.'T-er."l ■:c-r la ter 
'Isatitutlonal Guide ..." 



266 




DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE 

PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES OF HEALTH ^ ' ". 

BETHCSOA. MARVLANO 20014 '! ." - '^ 



Deceober 13, 1974 r .C :r. ? ■ 

ttrs. Lloyd B. Ui If ord .:"- o t . - : 

165 Voodlawn Avenue 

Decatur, Georgia 30030 -. r ---.:: ' - ■' .'< 

Dear Mra. tfllford: •'•.■ -•>- •• r --::' '- -' -.oi '•I - ': "o - • ,• c-r. 

" . o ' --'■•••- 
In typical bureaucratic fashion It la highly probable that noat of the 
copies of your Novenber 7, 1974, letter to the Department of Health, 
Edttcation, and Welfare will end up on sy desk. Tou will, as a consequence, 
probably receive several easentially Identical responses. 

tfe are enclosing a copy of our reply to Senator Nunn and copies of the 
enclosures. As an old protozoologist, I can aasure you that the Department 
does not propose, periait, or countenance research that confuses patients 
vith parameciuiB. I trust that the letter indicates our long concern with 
these issues. I will be glad to send you copies of our policy Issusnces 
dating back aa far »b 1953, if you are interested. They do not reflect 
the Interests of ligmoral and depraved persons. 

Doctor Ketzger appears to have relied on newspaper "morgue" material that 
was years old and grossly inaccurate. If medical reaearch was carried out 
In such a sloppy fashion we would still be giving mothers thalidomide. 
The accusations are a libel on both the Department of Defense and the 
University of Cincinnati. 

Senator Kennedy's concerns were widely circulated in the Cincinnati papers, 
yet none of the patients of their survivors made any issue of the matter. 
The Dnlverslty refused to release the patients ' names not only because of 
legal restrictions, but because of severe survivors' reactions to a previous 
attempt by a T.V. network to document the study with the University a 
cooperation. 

Several of the Ewlng'a ssrcoma cases treated at the hospital are atill altve 
and well several years after treatment, though the average survival of such 
patients is less than 6 months. It is to be regretted that this incident 
has halted what promised to be a very significant addition to our armamen- 
tarium against metastatic cancer. Similar work is going ahead in Canada, 
and in future years this country may well move even further ahead of us 
in the field of radiotherapy. 

Sincerely yours. 



D. T. Chalkley, Ph.D. 
Chief, Office for Protection 
from Research Risks 
Office of the Director 

Enclosure 



267 



Mrs. Lloyo B. Wilford 

16s wooolawn avenue 

decatur. georgia 30030 



November 7» 197^ 



Department of Health, Education and Welfare 
Washington, D.C. 20214 

Gentlemen: 

I find the attached almost beyond belief. STOP THIS! 

Where is the health, education, or welfare in a program 
that treats a human as it would a protozoan? V/hy should 
federal money be used in such programs at all? We should 
not allow such programs, much less finance them. 

Thousands of cancer victimswho read this will suffer the 
uncertainty of the nature of the treatments they receive, 
many apparently with reason. Research on human fetuses, 
aborted or otherwise, should never be allowed. You can- 
not possibly dare to continue or allow to continue such 
immoral and depraved crimes against citizens whether 
aborted, mentally ill victims of our society, or other 
innocents; certainly not in the name of the people of 
the United States. 

Stop it. In the name of God. 

Sincerely, 

cc: Senators Nunn and Talmadge -^ 

Representative Blackburn 
Secretary of the Army Callaway 



268 



iO-D '^^^ Jtldiilii Jaiiriiiil 

Aiiii si 

i 

Hyiiionleslii^g 



By TI. rETTIt MCTZCnn. Phd. 

taHTVtl^r Sflraca N'««« licrflr« 

It tisually- takes some great 
improvcmciU in a <-itua1ion to 
rralize just Inir bad things 
ha\-e been all aV.r.z. Consider • 
Tccul^tiiuis BOvcrr.i:iR medical i 
cxperiir.cnU pcn'onucd on 
Inmian bctngs. 

In t!ic fare of «ome fla- 
RraiiUy ijjir.ioral ibuses in Ihc 
past. li;c U.S. Dcpartjiient of 
ifcalUi. Fbucalion and Wel- 
fare tllEtV). lu<! finally come I 
tip with s.iine propo.'cl rul's I 
en kow federal noiwy can be i 
siwnlwlieii V'«plc arciiicd as j 
the subjects of laofiralorj- ox- ' 
pcriinciils. Tlic ;'r«iKisa l will 
t? open fnrj>u!;l;rwn-.incnt 
(niilc llEVt) uclil i^ovTli. " 

Included In ;c-n:e of tlie 
ac=:!y svigifestcd rules arc: 

— Tnstjtulionaliwd meiitM 
'Tvsti<3i:s ccn no liviRn" bo ^^cd 
as a cheap and convenient 
swirccof Mibjrcts for inodicnl 
iwcanh •which is imreln'.cd to 
Ihctf particular di»biUly. 

— Druc^ can vn lor.ur l>e ■ 
«dminiMcr«d to wonicn about 
1o unrtrrp* .-iborliim. just to 
sec »1ii! ofTrct lll^ li-u^s will 
liave on Uie fetus. 

— Jtcs-srch er. a'.,orted 
1:unian letw^Co s!/.uld Jie doiie 
only after the iii>pi(jjiri;ilc ani- 
Tnal 5<u<iics have been ex- 
liausted. 

— Mo t imporlnnlly. crtnscnl 
emnmi'*ccs must l;c c.'itah- 
IL^licd to n.akc sure tiut tlie 
p:.lionr.-. ««»:iseti« !o Ir.ke part 
jn an Ci.|irrimciit i-: ci^vn orly 
aftfrliis liavlng licen fully in- 
formal of Hie nrilure of llie 
cxpcrinvr.ls ami liirliculttrly, 
of an)- rikks im-oivcb. 

>Tnsl readers tinuld quUe 
naturally a.^fliir.c Uial such 
rules have been i;i fffrcl in 
rivHi/. .; nnlinns fi-r <I'v>l<'<. 
if not cinlurics. but Ikit u not 
Uwca&e. 



Wiafs worse. IfEW had to 
be forced iulo action by Con- 
Cress (Sen. P:<l-A7:rd M. 
Keimwiy in i«3rtitular). and 
by the occ.'i.s;(>nal horror 
stories given expovire bv ll\c 
press before it wow'd finally 
act. And at tliat, IfF.Ws 
proposals were pub'Js'ncd 
nwrc tlian a inonlli ofior lJ;e 
date promi.W originally, and 
do not ai>i>ly to researdi on 
children at all 

If you tliinlc th.it oilier 
pnifessionals. parlicjiarly in 
medical scienee. have been 
cffedJvc in the i)ast in polic- 
ing U;rir ovv-i .uf.ks. con.^iiler 
tho Univerjsily of Cincir4-..ili 
study d;Hie for ll.p IVnlagon 
between IKO and 1971. 

I 

The Cinrimali palienis i 
were not lold Hist the Inie 
purpose of the CNTuriments | 
was to determine the comU-.t • 
ctfectivenc.«s of troops after ; 
radiation su.";ta;rcd on the l>;it- i 
llcficid during an atomic war. 
Instead, lliey were told that 
tlie radiation tliey were to re- 
ceive might diminish Ilieir 
own cnnocr.?. All but tlirce 
wero diarily p.i!ienls and of 
lov.'or than averajje U). 

They were al«o not told thai 
flic 200 rad duses to IJieIr 
wliole bodies, not just t!:e can- 
cer itself, were dcatii-dcalijig 
in themselves. 

A1lhniii;h ;.U of tlio subjects 
had incui-ahlc cancer.';, thev 
were not inii'e final sLicrscf 
the disca.v; iinr even clu-c to 
death. In a Dofnue Pcp.ir'- 
ment d->cnm''ut. accordirp In 

a I'n.-.evsMy o; C..v;i ■,;; 

family rrpoi-*. on the subject, 
Uic doctors ilovribed the p.v 
lienU as "in relatively qo.i<l 
healili" and 'VLjiically stable, 
many of tlieni working daily." 

But "seven of Uie 18 receiv- 
ing the hiKher do^s iljn to 
200 rads) died within ZH day.;." 
close to 40 pisr cctit. said'llie 
faculty report. In all. at Ic.i.si 
87 patients were used as sub- 
jects. 

Tlie study w.^s drnp|icd' in 
1972 wlien the j»resident of Ilie 
UnivorMly n-fnvd to accept 
additional IVrlicon money !o 
pay for aniiiii; cancer pa- • 
licnla 



Sen. Mike Travel a.'»e<I 
some oiiLside (<>iysiriaa'> to 
ini'cstic.ite. Allimush the 
study was discredited, the 
American College of Itidiol- 
ojy f ACft 1 oan-o to the rescue 
of the radioli..':ist.<: who ran 
the project. A thrcc-<loetor 
committee appointed by the 
head nf the ACIl actually com- 
mended ijie p."oJLXt. 

llic ACa rcr-rl does not 
identify olhi r centers in ttie 
coiintrj- w ii e r tf wh.iloUidy 
radiation is us<sl f.>r localized 
cancrrs. ncr will hn^pit.il nn- 
Ihnrities in <"ir.cinn;iti al>w 
Sen. Koiir,K;y\ j.|.iff ti ir^T- 
view Ihc .siinivn:? paticn'.«. 
All of whi-li illiLsl.-atis how 
naive It is to c.\|«ci nril.cid 
esperimciilcrs u> police U;sji- 
sclvcs. 





I 



269 



Published in Scientific Literature 



PUBLISHED PAPERS - Under DASA Contract - Radiation Effects in 
Cancer Patients 

Comparison of Serum Phenylalanine Levels with Growth in 
Guthries's Inhibition Assay in Newborn Infants. Carolyn Scheel 
and Helen K. Berry. The Jour, of Pediatrics, Vol. 61, No. 4, pp. 
610-616, October 1962. 

Deoxycytidine in Urine of Humans after Whole-Body Irradiation. 
Helen K. Berry, Eugene L. Saenger, Harold Perry, Ben I. Friedman, 
James G. Kereiakes and Carolyn Scheel. Science, October 18, 
1963, Vol. 142, No. 3590, pp. 396-398. 

Deoxycytidine Levels in the Urine of X-irradiated Rats. James G. 
Kereiakes, Eugene L. Saenger, and Helen Berry. Abstracted in 
Radiation Research, Vol. 22, No. 1, May 1964. 

Urinary Excretion of Amino Acids and Nucleosides by Cancer 
Patients Following Whole-Body Irradiation. E.L. Saenger, J.G. 
Kereiakes and Helen Berry. Abstracted in Radiation Research, 
Vol. 22, No. 1, May 1964. 

Endoreduplication in Leucocyte Chromosomes: Preliminary Report 
of its Relation to Cancer and Whole-Body Irradiation. Ben I. 
Friedman, Eugene L. Saenger and Michael S. Kreindler. The 
Lancet, September 5, 1964, pp. 494-495. 

Specific Proteins in Serum of Total -Body Irradiated Humans. A.J. 
Luzzio, B.I. Friedman, J.G. Kereiakes and E.L. Saenger. The 
Jour, of Immunology, Vol. 96, No. 1, pp. 64-67, 1966. 

Hematologic Effects of Total -Body Radiation in the Human Being. 
Gould A. Andrew, C.C. Lushbaugh, Ralph J. Kniseley, David A. 
White and Ben I. Friedman. This paper was presented at the 
Incernational Atomic Energy Agency Panel on the Effects of 
Various Types of Ionizing Radiation from Different Sources on the 
Haematopoietic Tissues, meeting in Vienna, Austria, May 17-20, 
1966. Published in Proceedings by IAEA, Vienna, 1967, 
STI/PUB/134, pages 75-83. 



270 



Effects of Whole and Half Body Irradiation in Human Beings with 
Cancer. E.L. Saenger, B.I. Friedman, J.G. Kereiakes and H. 
Perry. Published in the Proceeding of the Third International 
Congress of Radiation, Cortina d'Ampezzo, Italy, June 26-July 2, 
1966, p. 191, abstract #759. 

Effects of Total Partial Body Therapeutic Irradiation in Man. 
Eugene L. Saenger. Published in Proceedings of the 1st 
International Symposium on the Biological Interpretation of Dose 
from Accelerator-Produced Radiation - Held at the Lawrence 
Radiation Laboratory, Berkeley, California, March 13-16, 1967. 
Published U.S. Atomic Energy Commission/Division of Technical 
Information, CONF-670305, p. 114-227. 

Colorimetric Analysis of Deoxycytidine in Urine After Separation 
by Ion-Exchange Column Chromatography. I -Wen Chen, James G. 
Kereiakes, Ben I. Friedman and Eugene L. Saenger. Analytical 
Biochemistry, Vol. 23, No. 2, May 1968, pp. 230-240. 

Radiation- Induced Urinary Excretion of Deoxycytidine by Rats and 
Humans. I-Wen Chen, James G. Kereiakes, Ben I. Friedman and 
Eugene L. Saenger. Radiology, Vol. 9 No. 2, pp. 343-348, August 
1968. 



Total and Half Body Irradiation: Effect on Cognitive and 
Emotional Processes. Louis A. Gottschalk, Robert Kunkel, 
Theodore H. Wohl, Eugene L. Saenger and Carolyn N. Winget . Arch. 
Gen. Psychiat. Vol. 21, pp. 574-580, Nov. 1969. 

Cytologic-Biochemical Radiation Dosimeters in Man. E.G. 
Silberstein, I-Wen Chen, E.L. Saenger and J.G. Kereiakes. 
Published in Proceedings "Biochemical Indicators of Radiation 
Injury in Man "International Atomic Energy Agency, PL-409/13, pp. 
181-214, Vienna, 1971. 



I 



271 



PRESENTATIONS 

Bone Marrow Dosimetry in a Cobalt 60 Irradiated Tissue Equivalent 
Human Phantom, presented by James G. Kereiakes at the Second 
International Conference on Medical Physics, Boston, 
Massachusetts August 11-15, 1969. 

Effect of Total and Partial Body Radiation on Cognitive- 
Intellectual Functioning and Emotional Reactions, C.C. Gleser, 
C.N. Winget, R.L. Kunkel and E.L. Saenger. Presented at the DASA 
Medical Coordination Conference "Radiation- Induced 
Incapacitation/Performance Decrement", Armed Forces Radiobiology 
Research Institute, Bethesda, Md. 18-19 November 1969. 

Cytologic-Biochemical Indicators of Radiation Injury in Man. 
Presented by E.B. Silberstein at the WHO/IAEA Conference, Paris, 
June 22-26, 1970. 

The Changing Picture of Bone Marrow Granulocyte Reserves in 
Irradiated Patients. Presented at the Experimental Hematology 
Society by E.B. Silberstein, November 12-13, 1970, Pittsburgh. 

Presentations listed below were made by staff of the Radioisotope 
Lab. at the Joint Oak Ridge Associated Universities-Defense 
Atomic Support Agency Information Exchange Program "Radiation 
Effects on Biological Systems," Oak Ridge, Tenn. March 29-30, 
1971. 



I 



A Closed System for Marrow Transplantation - E.B. 
Silberstein 

Chromosome Aberrations as a Dosimeter of Whole Body 
Irradiation - E.B. Silberstein 

Active Bone Marrow Doses in Whole-Body and Partial Body 
Exposures - J.G. Kereiakes 

Serum and Urinary Amylase Activities in Irradiated 
Cancer Patients - E.L. Saenger 

The Relationship of Nausea and Vomiting to Radiation 
Dose - E.L. Saenger 

In vitro studies of Chromosome aberrations caused by 
Irradiation - E.B. Silberstein 



272 



Ultraviolet -Absorbing Compounds in Urine of Two 
Irradiated Cancer Patients as Determined by High- 
Resolution Column Chromatography - E.L. Saenger 

Active Bone Marrow Dose Related to Hematological Changes in Whole 
Body and Partial Body Exposures - J.G. Kereiakes, E.B. 
Silberstein, E.L. Saenger, W.G. Van De Riet and C. Born - 
submitted for presentation at the Annual Meeting of the 
Radiological Society of North American in December 1971. 

Bone Marrow Dose in Whole and Partial Body Cobalt 60 tissue- 
equivalent human phantom. C. Born, J.G. Kereiakes, G.K. Gahr and 
G.H. Simmons, presented at the annual meeting of the AAPM, 
Houston, Texas, July 1971. 

PRESENTATION - Made under DASA contract - Radiation effects on 
cancer patients 

Radiation Casualties-Newer Aspects of Mass Casualty Care. 
Presented by Eugene L. Saenger and Max L.M. Boone, at the 
Thirteenth County Medical Societies Conference on Disaster 
Medical Care, American Medical Association, Chicago, Illinois, 
November 4, 1962. 

Deoxycytidine Levels in the Urine of X- irradiated Rats. 
Presented by James G. Kereiakes at the Annual Meeting of the 
Radiation Research Society, May 1964, Miami Beach, Florida. 

Urinary Excretion of Amino Acids and Nucleosides by Cancer 
Patients Following Whole-Body Irradiation, presented by E.L. 
Saenger at the Annual Meeting of the Radiation Research Society, 
May 1964 at Miami Beach, Florida. 

Autologous Bone Marrow Storage and Infusion in Patients Receiving 
Whole Body Radiation. Presented by Ben I. Friedman at the 
American College of Physicians Regional Meeting in Pittsburgh on 
November 20, 1965. 

Effect of Whole and Half-Body Irradiation in Human Beings with 
Cancer. Presented by Eugene L. Saenger at the Third 
International Congress of Radiation Research, Cortina d"Ampezzo, 
Italy, June 26, July 2, 1966. 

Hope and Denial in Metastatic Carcinoma - A Preliminary Report. 
Presented by Dr. Robert L. Kunkel at a Psychosomatic Meeting in 
New Orleans, 1966. 

Effects of Total and Partial Body Therapeutic Irradiation in Man. 
Presented by Eugene L. Saenger at the Proceedings of the 1st 
International Symposium on the Biological Interpretation of Dose 
from Accelerator- Produced Radiation. Held at the Lawrence 
Radiation Laboratory, Berkeley, California, March 13-16, 1967. 



273 



Quantitive Analysis of Deoxycytidine in the Urine of Irradiated 
Cancer Patients and Rats. Presented by James G. Kereiakes at the 
DASA Symposium, U.S. Naval Radiological Defense Laboratory, San 
Francisco, California, April 9-11, 1968. 

The Management of the Acute Radiation Syndrome in Man. Presented 
by Eugene L. Saenger at the DASA Symposium, U.S. Naval 
Radiological Defense Laboratory, San Francisco, California, April 
9-11, 1968. 

Bone Marrow Dosimetry in a Cobalt 60 Irradiated Tissue-Equivalent 
Human Phantom. Presented by James G. Kereiakes at the DASA 
Medical Coordination Conference, Air Force Weapons Laboratory, 
Kirkland Air Force Base, New Mexico, May 27-29, 1969. 

Radiation- Induced Urinary Excretion of Deoxycytidine by Rats and 
Humans. Presented by I -Wen Chen at the Annual Meeting of the 
Radiological Society of North America, Chicago, Illinois, 
December, 1967. 



274 



TECHNICAL REPORTS 

Submitted by University of Cincinnati to 
Defense Nuclear Agency (DNA) formerly DASA 



Report Period 
Feb. 1960 thru Oct. 1961 

Nov. 1961 thru Apr. 1963 

May 1 963 thru Feb. 1 964 

Feb. 1960 thru Apr. 1966 

May 1966 thru Apr. 1967 

May 1967 thru Apr. 1968 

May 1 968 thru Apr. 1 969 

May 1969 thru Apr. 1970 

May 1 970 thru Apr. 1 971 



Title 

Metabolic Changes in Humans 
Following Total Body Radiation 

Metabolic Changes in Humans 
Following Total Body Radiation 

Metabolic Changes in Humans 
Following Total Body Radiation 

Metabolic Changes in Humans 
Following Total Body Radiation 

Metabolic Changes in Humans 
Following Total Body Radiation 

Radiation Effects in Man; 
Manifestations and Therapeutic Efforts 

Radiation Effects in Man; 
Manifestations and Therapeutic Efforts 

Radiation Effects in Man; 
Manifestations and Therapeutic Efforts 

Radiation Effects in Man; 
Manifestations and Therapeutic Efforts 



Contract No. 


DASA 
Report No. 


DA-49-146-XZ-029 


None Assigned 


DA-49-146-XZ-029 


DASA 1422 


DA-49-146-XZ-029 


DASA 1633 


DA-49-146-X2-315 


DASA 1844 


DA-49-146-X2-315 


DASA 2179 


DA-49-146-XZ-315 


DASA 2163 


DA-49-146-XZ-315 


DASA 2428 


DASA01-69-C-0131 


DASA 2599 


DASA01-69-C-0131 


DNA 2751 T 



275 

Mr. Bryant. You testified that funding was obtained from the 
National Institutes of Health and that most costs were paid by Cin- 
cinnati Greneral Hospital. 

We have found one indication, as I mentioned earlier today, that 
the National Institutes of Health refused to participate on the 
grounds of its concern about the moral implications of going for- 
ward. 

Dr. Saenger. Yes. I mentioned in my presentation the National 
Institutes of Health maintained a General Clinical Research Center 
for the purpose of metabolic study which was available to any pro- 
gram within the medical center which would satisfy their require- 
ments. One had to submit a protocol and so on. And we were allot- 
ted one bed there for a period of time. And we had several patients 
on this service. 

And in order for us to maintain that service — maintain that 
availability, it was required that we submit the protocol and the 
course of these patients. And we used this in great part for our de- 
velopment of autologous marrow harvesting and reinfusion. 

And this — this was — these were the reports that Dr. Chalkley of 
the Office of Risk Protection at the NIH responded to in his com- 
ments to a letter that he had received. Did I make that clear? 

Mr. Bryant. Not exactly. You might elaborate a little bit. 

Dr. Saenger. The NIH maintained a service, a ward, in our hos- 
pital, which they paid for totally. When a patient was put in that 
ward the funds were supplied totally by the NIH. This ward was 
there for conducting nutritional balance studies, looking at meta- 
bolic studies for a variety of purposes. 

And we put several of our patients in this particular service so 
that we could study particularly the autologous bone marrow trans- 
plantation technique that we were working out. It took us some 
time to do that before we were successful in the five patients to 
whom I referred. 

In order that the NIH could maintain this funding we had to give 
them reports of the protocol and the progress of the patients, and 
we did that. And these were approved. 

Now the other research projects that we submitted to the NIH 
were turned down for purposes which I don't recall exactly at this 
moment. They accepted this work that we did with the General 
Clinical Research Center. 

Mr. Bryant. Are you saying that this — I am looking for some 
clarification. We have had implication from some of the documents 
we saw that the NIH refused to go along with the whole body radi- 
ation treatment experiments because of moral questions. Does your 
answer indicate they did go along with it? 

Dr. Saenger. They did go along in the studies of these several 
patients that we reported. And we then made a subsequent request 
for additional funding after our contract with the DOD was termi- 
nated. And it was those — ^that was that proposal I think that they 
declined. 

Mr. Bryant. On the grounds that they had some moral 

Dr. Saenger. I do not know the grounds. 

Mr. Bryant. Well, our indications are that they were concerned 
about the moral implications of it. Is that a surprise to you? 

Dr. Saenger. As to what? 



276 

Mr. Bryant. About the moral indications. 

Dr. Saenger. I think there was some difference of opinion about 
informed consent. I might say, in that regard, from the time we de- 
veloped the first informed consent in 1965 we submitted several 
additional informed consents which I believe you have in your doc- 
uments. These were done at the request of the Human Research 
Committee and were approved. 

Our final informed consent technique that we used was a 2-day 
informed consent where the patient would be — where the study 
would be explained to the patient and/or his family or other — min- 
ister, lawyer, whoever — on one day. And on a second day we would 
again repeat this process. And if the patient agreed to it then it 
would be a signed, informed concept. 

So we went through a rather elaborate series of improvements on 
informed consent. 

Mr. Bryant. The first question would be, did these people have 
the capacity to understand what was being told to them and to give 
consent? That was one of the criticisms raised, that they were not 
capable of understanding what you were asking them about and, 
therefore, not able to give informed consent. Could you respond to 
that? 

Dr. Saenger. My response to that — our physicians who carried 
out the informed consent procedure were very careful to explain 
this work to the patients in most if not in all cases prior to the 
written informed consent period. We had one of our nurses or other 
research associates accompany the physician with the patient so 
that this explanation would be carried out so that they would un- 
derstand it. 

And we do have several recordings where we had taped the in- 
formed consent procedure with the patients. 

Mr. Bryant. Dr. Egilman further pointed out there was a 25 per- 
cent chance of very rapid death from the whole body radiation 
treatment. I ask the question, why weren't these people told they 
might die rather than in several months or years but instead in a 
few weeks? 

Dr. Saenger. I have looked at a great many written informed 
consent procedures that have been developed over the years. I have 
yet to see one in which the risk of death is explicitly stated in the 
written informed consents that I have reviewed. 

Mr. Bryant. Well, I don't wish to impose a standard, a 1994 
standard on actions back in the 1960's and early 1970's, but it does 
seem to me to be a fairly simple concept that if a person is ill and 
is probably going to live many more months or probably even a cou- 
ple of years, if they run a significant risk of dying immediately or 
within a few weeks, that that is something that you would just nor- 
mally tell them. 

Dr. Saenger. I think we explained to the patients that they 
might benefit and they very well may not benefit from the treat- 
ment. I don't think that we could be guarantors of results because, 
as you can see from our studies, we had some 20 patients who lived 
longer than a year. 

And I think that it is really impossible to determine in any single 
case how long a patient will survive. We had some patients who we 



277 

thought would not survive, and they seemed to improve tremen- 
dously and live for several months. 

Mr. Bryant. I think you are confirming Dr. Egilman's statement 
that these patients were not told that they would, as a result of the 
whole body radiation, die much more rapidly due to the treatment. 

Dr. Saenger. I don't think that in anyone's experience it is pos- 
sible to foretell the exact time of death after any treatment which 
is given. We gave this treatment with the understanding that it 
would improve the patient's welfare either by prolonging survival — 
we did the best we could in that regard — and we gave them the 
very best we were capable of in terms of shrinking tumors, improv- 
ing well-being. 

We got many statements from these patients which support what 
I am saying to you. 

Mr. Bryant. Mr. Mann. 

Mr. Mann. Mr. Chairman, thank you. 

Just to follow up on that point. Dr. Saenger, do you agree with 
Dr. Shields' statement that Dr. Egilman quoted that there was 25 
percent mortality? 

Dr. Saenger. I do not agree with that at all. 

Mr. Mann. So how — what was the risk then of death within a 
few weeks of treatment? Dr. Shields said one in four. How would 
you- 



Dr. Saenger. I think there was a risk of death within a short 
period of time after treatment. But the question is what was the 
risk due to. In our opinion, in reviewing these charts over and over 
again, it seemed to us that the primary reason for death within a 
few weeks after the treatment or in a few cases within a few days 
was the growth and the — the rapid growth of a tumor rather than 
the treatment. 

If you look at the amount of radiation which we gave to these 
people in light of the further development of whole and partial 
body radiation, we find the patients today are living with doses of 
600 to 1,200 rads, and our doses of up to 200 rads were really at 
a very low dose compared to what we see in survival today. 

And it is not reasonable to assign radiation as the sole or major 
contributing cause of death in this series of patients. 

Mr. Mann. Your paper that you published in 1973 does suggest 
that eight of the patients may have had their death accelerated as 
a result of the whole body radiation. Isn't that true? 

Dr. Saenger. What we said in that paper was if one assumes 
that all severe drops in blood cell count and all instances of 
hypocellular or acellular death were due only to radiation and not 
influenced by the type or extent of cancer and the effects of pre- 
vious therapy, then one can identify eight cases in which there is 
a possibility of therapy contributing to mortality. 

The fact that — that was the statement in the paper. 

The fact is that these patients did have far advanced cancer and 
had other forms of therapy before and after. And, therefore, the as- 
sumption is just that. It is not what actually occurred. We have 
looked at these charts recently and find the course of these pa- 
tients — the downhill course of these patients to have been due to 
cancer. 



278 

Mr. Mann. It is no longer possible that those eight died because 
of treatment? 

Dr. Saenger. I am sorry? 

Mr. Mann. Are you saying that the statement in the paper of 20 
years ago that it was possible that those eight had mortality ad- 
vanced because of treatment is no longer, in your opinion, the case'' 

Dr. Saenger. That is my opinion. May I continue? 

Mr. Mann. Yes, I am sorry. 

Dr. Saenger. Also, statistically, we would have found the mortal- 
ity of these patients would have differed from the mortality of pa- 
tients treated by other means. 

In our patients, it does not differ. That we can see in the survival 
curves in our 1973 paper. 

Mr. Mann. Now, I want to go to your own documents, which I 
think are the most difficult part of all this, at least for me. 

I have looked at your 1958 proposal to DOD, the contract with 
DOD, as I indicated in my opening comments, the reports that 
were made periodically from the beginning of the study in Feb- 
ruary 1960 until April 1967. And in none of those documents can 
I find any indication that there is any purpose to the study what- 
ever other than to identify a biological marker or biological link 
that would allow the Department of Defense to administer simple 
tests and determine how much radiation a soldier in battle had re- 
ceived. 

And the question I think we all have is, if this was about treat- 
ment and this was about therapy, why would there be no mention 
in all these documents for all those years? 

Dr. Saenger. I would like to refer you to our 1962 document pre- 
pared for the Defense Atomic Agency. 

Mr. Mann. I have it. Yes, sir. 

Dr. Saenger. The eligibility for patients entering this treatment 
was spelled out. "There is a reasonable chance of therapeutic bene- 
fit to the patient. The likelihood of damage to the patient is no 
greater than that encountered in comparable therapy of another 
type." 

Furthermore, I would refer you to the statement of J.A. Isher- 
wood 

Mr. Mann. That we discussed earlier? 

Dr. Saenger. Yes, that was discussed earlier. That clearly identi- 
fies the attempt to improve the condition of cancer patients with 
that therapy. 

Mr. Mann. Focusing on that, your 1958 proposal says nothing 
about patient therapy. And Dr. Isherwood sort of gratuitously 
starts talking about the project will be of great value in the field 
of cancer. How would he know that? What did he have beyond the 
proposal that would allow him to reach such a conclusion? 

Dr. Saenger. Well, I really can't answer that except to say to 
you that we had discussed this proposal with the Department of 
Defense people involved, so that I think we had indicated that this 
was the primary intent of our work. The reason that we phrased 
our reports to the Department of Defense in the way we did is that 
that was what they were interested in and that is what we tried 
to teU them about. 






279 

But that did not have an5rthing to do — ^that did not interfere in 
any way with the therapeutic intent of the program. 

Mr. Mann. Doctor, you referred to a 1962 document that you 
submitted to DOD. For what reason — ^what were the circumstances 
that led to the drafting and submittal of that document? 

Dr. Saenger. My recollection was that the DOD had requested 
us to give them an overview of where we thought this whole pro- 
gram was going, and at the time we made that report. 

Mr. Mann. Just tracking through what we have here so that — 
the reports, we are saying, other than the 1962 document, were ti- 
tling the project, metabolic changes in humans following total body 
irradiation and the aims and scope of the project had continued 

Let me just read from one of the reports. This is November 1961, 
to April 1963. This information is necessary to provide knowledge 
of combat effectiveness of troops and to develop additional methods 
of diagnosis, prognosis, prophylaxis, and treatment of injuries that 
would be suffered, as I understand, from radiation. 

That continues to be pretty much the way it is all characterized 
until suddenly the report that was released after April 1968, the 
title is changed. The title now is, "Radiation Effects in Man: Mani- 
festations and Therapeutic Efforts." That was the title that was 
used for the reports that were submitted for the period of the 
project. May 1967 until March 1972. 

What was the reason for the change in title? 

Dr. Saenger. I think part of that developed from our work with 
autologous bone marrow transplantation and our effort to be able 
to control the depression of bone marrow. 

We also found at that time, in that work, that with the use of 
autologous bone marrow infusion, reinfusion, that the patients did 
not seem, at least clinically to me, to get as sick as they did before 
in the period immediately after radiation. And certainly their 
course was ameliorated by the fact that their blood count came 
back to normal much more quickly than they did before we used 
that technique. 

Mr. Mann. So the therapeutic efforts would be describing the use 
of bone marrow transplant? 

Dr. Saenger. If you look at our initial proposal in 1958 to the 
development of this entire project, I like to think we became more 
and more sophisticated in what we were doing and became more 
knowledgeable about the effects of radiation, and we understood a 
great deal more about the therapeutic benefits that we were 
achieving. 

Mr. Mann. There is one last report that covers the time period 
April 1971 to March 1972. This continues to have this new title. 
But it also — and I think it is the first time that the purpose of the 
study is described in this way. 

March 1972, the purpose is as follows: 

The purpose of these investigations has been to improve the treatment and gen- 
eral clinical management and, if possible, the length of survival of patients with ad- 
vanced cancer since systemic effects of radiation therapy have been given particular 
attention in our work. 

In fact, there is virtually no mention of Pentagon interest or Pen- 
tagon purpose. Now why was the purpose of the work characterized 
so dramatically differently in March 1972? 



280 

Dr. Saenger. May I get a copy of that? 

Mr. Mann. Yes, sir. 

Dr. Saenger. That was the April 1971 to 1972 

Mr. Mann. April 1971, to March 1972, yes, sir. 

Dr. Saenger. I think, Congressman, you will find that to be al- 
most the exact duplicate of the published paper in 1971. 

Mr. Mann. I think that is true. But, as I understand, this is the 
final report of which I am aware to the Department of Defense 
And the question is why the purposes of the work are so dramati- 
cally transformed or at least stated in such a dramatically different 
fashion. 

Dr. Saenger. I thought it was a pretty good report. I summa- 
rized what we had learned over the 10-year period. 

Mr. Mann. I am not questioning that. 

The question is— I read to you what the purpose was stated to 
be of the work in your earlier reports. And it was all focused on 
the battlefield and so forth. And, suddenly, the battlefield and the 
Pentagon is not mentioned. I was curious. 

The question is, what is the reason for the different characteriza- 
tion? 

Dr. Saenger. I think part of the reason for the characterization 
is that we — this whole research came under a great deal of criti- 
cism, and we were pointing out what the value and the benefits of 
our therapeutic part of the study was, in addition to the informa- 
tion which we gave to the Department of Defense 
Mr, Mann. Thank you. 

Now, I want to ask a few questions out of Dr. Suskind's study 
Dr Suskind is present, I notice. We appreciate his presence. 

But on page 12 of the report— I am quoting— although whole 
body radiation is widely used for many forms of radiosensitive tu- 
mors, no information is available to the committee which indicates 
that this form of treatment is used elsewhere in radioresistant or 
localized cancers as used at the University of Cincinnati. The first 
one is, do you agree with that statement? 

Dr. Saenger. Well, there are three references that are cited 
there. We have cited in the documents that we have prepared for 
this a great many papers on this subject. And this was written by 
the committee. It was not written by me. 
Mr. Mann. Do you disagree with his statement, sir? 
Dr. Saenger. All I can say is it is the committee's opinion. I did 
not write this report. 

Mr. Mann. Yes, sir. Do you agree or disagree 

Dr. Saenger. I don't have to agree or disagree with it. Their sur- 
vey of the literature is their survey. 

Mr. Mann. I am asking you, sir, whether, in your professional 
judgment or professional opinion, do you— you — I am asking you to 
develop an opinion. Do you agree or not agree? 

Dr. Saenger. This says that the committee didn't find— it says, 
the committee — no information is available to the committee. I was 
?r°V^ "ie."iber of the committee, and I did not review this report. 
If they didn't find information in this regard, which we have sup- 
plied in our bibliography, submitted to this— to your committee, I 
don t know what to say about it. 



281 

Mr. Mann. So you believe, in your opinion, the treatment was 
being used elsewhere in radioresistant or localized cancers? 
Dr. Saenger. In the diseases that we treated, I would say yes. 
Mr. Mann. Quoting again from the study, this is page 14: 

The committee, however, was unable to find any written protocol in which the 
purpose of the study, which is determined palliative effects of whole body irradia- 
tion, until the protocol entitled. The Therapeutic Effect of Total Body Irradiation 
Followed by Inftision of Stored Analogous Marrow in Humans was resubmitted to 
the Chairman of the research committee by Dr. Ben Friedman, then principal inves- 
tigator, on April 13, 1967. 

Dr. Saenger. Again, I would have to refer you to our statement 
made to DASA in 1962. I cannot say whether Dr. Suskind's com- 
mittee was familiar with that statement or not. 

Mr. Mann. So your 1962 document to DOD is a written protocol? 

Dr. Saenger. I think it is fairly explicit. 

Mr. Mann. All right, sir. I am going to yield for the moment. I 
will pick up on the second round. 

Mr. Bryant. Mr. Portman. 

Mr. Portman. Thank you, Mr. Chairman. 

Dr. Saenger, thank you for agreeing to be before us today. 

Just to back up, again. My view is that the role of this sub- 
committee is to help determine the appropriateness of compensa- 
tion for the families, and it is in that context that I ask these ques- 
tions. 

And first, of course, informed consent. You have mentioned in 
your response to Mr. Bryant and I believe in your testimony that 
the attending physicians were responsible for providing information 
as to risks, benefits and so on. I just wondered — perhaps this is in 
the record. I haven't seen it. And there are many documents I have 
reviewed. But who were these people that were informing the pa- 
tients — who were these the internists or radiologists? Who were the 
attending physicians? 

Dr. Saenger. The principal ones I have identified: Dr. Harold 
Perry, who was responsible for the radiotherapy in our institution 
from about 1957 until about 1965; Dr. Horowitz, a radiation thera- 
pist, who was from about 1965 to 1968; Dr. Ben Friedman, an in- 
ternist and hematologist who was with us from about 1963 to 1965 
or 1966 — I can't give you these exact dates; I don't have them — Dr. 
Silberstein, who began in 1967, I believe; and Dr. Bernard Aron, 
who began in about 1966. 

Now these are all board certified specialists in their fields either 
of radiation oncology or internal medicine, nuclear medicine. And 
I think they are very responsible physicians and have been very 
highly regarded in this community and nationally. 

Mr. Portman. Further, on the issue of informed consent, having 
heard a lot about that today and having looked at it quite a bit 
over the last few months, there is a lot of conflict, I believe, out 
there between, as an example, the Hippocratic Oath on the one 
hand, and codes that were adopted later, the various practices of 
hospitals and so on. We have heard today that standards of disclo- 
sure were evolving during this time period, the 1950s and 1960s. 

My question to you is, do you believe that the experiments devi- 
ated in any way from the standards that govern informed consent 
at that time? 



282 

Dr. Saenger. Absolutely not. I think we complied fully with in- 
formed consent. I think we were in the advance of techniques of in- 
formed consent throughout this study. 

Mr. PORTMAN. There has been discussion today about radiation 
doses being lethal or close to lethal. You stated earlier in response 
to Mr. Bryant's question that today there continue to be whole body 
radiation treatments. You indicated that the rads were higher, al- 
though I am a little confused as to the intervals. If you could per- 
haps flesh that out a little further and then just give us your opin- 
ion as a radiologist as to the question of lethal or nonlethal dose 
in the period of 1971. 

Dr. Saenger. When we began our works we were feeling our way 
very gingerly, and we believed that somewhere around 150 to 200 
rads of whole body radiation was about as high as we could go 
without getting into trouble. 

After our project was terminated, at the point when we were able 
to maintain better control of the patients with our autologous bone 
marrow infusion, we then find from looking at the literature that 
other centers continuing in this work, many treating the same and 
different cancers, were using doses of two, three and four times the 
size, the amount that we were using, with success. 

If you go back and look at what we were doing, it would seem 
to indicate very strongly that the doses that we were considering 
as getting pretty close to a danger point were really not. And this 
is one of the reasons that we were able to conclude that the deaths 
in many of these patients, as they died, were due to the progress 
of their cancer, which was growing exponentially, rather than as a 
result of the comparatively small doses of radiation that we were 
giving both whole body and partial body, 

Mr. PoRTMAN. Again, could you just flesh out a little further as 
to today's practices in terms of levels of— I believe you talked about 
levels in the 600 to 1,200 range but indicated that treatment would 
perhaps be given at intervals. This is today's practice. 

Dr. Saenger. Today's practice in some institutions, they still will 
give 1,000 to 1,200 rads as a single dose. Now what is found in 
those patients is that they don't die of the acute radiation syn- 
drome. They die of a subsequent radiation pneumonitis. 

And in order to get around the problem of dying of radiation 
pneumonitis and still accomplish the intended therapy, which is to 
either treat the cancers or ablate the bone marrow, it has been 
found that one can fractionate the dose. And by that you would 
perhaps give four doses of 300 rads, say, a day or every other day, 
for a period of time. You would give 200 rads a day times five to 
get — for five days to get to 1,000 rads. 

Furthermore, in today's treatment of cancer, these patients now 
are getting several series over a period of weeks of intensive chem- 
otherapy, then getting this total body therapy and then going back 
to intensive chemotherapy. So that the amount of chemicals and 
radiation which are damaging to the bone marrow are really in 
terms of what we were doing back in the 1960's. It is sort of, I 
guess, fantastic. And patients are surviving this. 

Mr. PoRTMAN. The final question in the area of informed consent. 
This has to do with the selection of the patients. Many patients 
had a lower level of education. Many are indigent. 



283 

I know in response to an earlier question you indicated you 
weren't involved in the selection. If you have anything further on 
that, I would be happy to hear about it. 

But my concern is, really, do you think that that is relevant? 
Does that bear on the informed consent question specifically? 
Would that same patient group be selected today, even with the 
evolving higher standards of informed consent? 

Dr. Saenger. I would like to respond to that because I think it 
is a very important question. It has been of great interest to me 
to first listen to several of the taped consent interviews which we 
have with several of our patients. And irrespective of their IQs or 
level of illness and so on, I can tell you that from my experience 
of some 50 years in handling cancer patients, that these patients 
were thoroughly aware of their situation. They understood that we 
were going to try and do something for them which might be help- 
ful and might not. 

In addition to that, we did something that is unique in the field 
of stud3dng radiation effects in cancer patients. We had a very 
elaborate program of investigating the psychological and psy- 
chiatric reactions of these patients to their treatment. And part of 
this consisted of 5-minute interviews where the psychologist would 
simply take a tape-recorder and put this in front of the patient and 
say, talk for 5 minutes about anj^thing you want to. 

Now, what happens in these situations was that these patients 
are first interviewed in that fashion immediately when they began 
on our study program. That took us usually 2 or 3 weeks to get 
them all prepared, worked up, as we say, tested with our various 
laboratory tests and undergoing sham radiation, which we did 
carry out. And each time we had this interview. 

Then the patients were interviewed just before they were treat- 
ed, just after they were treated, and for a 3-day interval, I believe, 
a 7-day interval, as long sometimes as 6 weeks. 

I have only listened to a few of these tapes, and I can tell you 
that these patients are understanding, sensitive and alert to their 
conditions, to their treatment, to their progress, to the fact that 
their tumors are growing, that sometimes they feel better, some- 
times they feel worse, and they are as sensitive as any individual 
in this room today. 

And I do not believe that all of this talk about the poor and 
uneducated and low IQs and so on had anything to do with their 
ability to perceive their situation in life and how it is progressing. 

Mr. PORTMAN. The next major issue is the DOD role, the Govern- 
ment role in all of this. 

I, too, have questions about your reports back to DOD. Congress- 
man Mann quoted from a couple of those reports. 

I wish DOD were still at the panel because I would like to hear — 
and perhaps we can now. Dr. Soper, hear from you later about 
other examples where DOD responded with an institution in terms 
of the effects versus the treatment, because it seems to me that Dr. 
Saenger's statement that this is what DOD was interested in and 
concerned about and, therefore, that was what was in the report 
might be something that we should look into in terms of other re- 
porting that was done in other experiments around the country. 



284 

But my general question, I suppose, is, would you have gone 
ahead without DOD? 

Dr. Saenger. Yes. We had Dr. Perry. We had Dr. Kereiakes. We 
had the physical equipment and so on. And we would have pro- 
ceeded whether or not we had DOD's support. DOD's support was 
not used for the treatment of the patients. 

As we have emphasized, the GAO investigated this question, and 
I think the conclusion is inescapable that the DOD function was 
entirely separate from the therapy of the patients. 

Mr. PoRTMAN. My final question really is how DOD used the in- 
formation. There is very little in the file that I find, at least as to 
DOD reporting back on how it used the information that the ex- 
periments in Cincinnati provided to them. Are you aware of any 
DOD reports generated during the study period or after the study 
period as to how they used the information that was provided? 

Dr. Saenger. I cannot give you the exact times that I met with 
DOD people, the DNA personnel and other Army and other com- 
mands. But there were several meetings which I attended. There 
was data that I worked on with them to develop the manuals 
which they use in the field for the commanders and for the person- 
nel in the field in the event of nuclear warfare. 

I don't have the information that Dr. Soper had about the exact 
manuals today. But I have participated in these, and I know — at 
least I am led to believe that our information was useful to the 
DOD in this regard. 

I know that some of the studies, the psychological studies were 
of some help in interpreting what they find is a very important 
consideration of performance. 

Mr. PORTMAN. And you are led to believe that some of the infor- 
mation provided was useful in compiling manuals 

Dr. Saenger. I attended some conferences from time to time 
with DOD personnel. The only thing I can't tell you today is the 
exact date, location of those meetings. I think I could find some of 
this information. 

Mr. PORTMAN. I think some of that is relevant— at least in my 
mind it is relevant to the issue of the DOD role. 

Thank you very much. Dr. Saenger. 

Mr. Bryant. Dr. Saenger, you mentioned a moment ago — I am 
sorry. Dr. Egilman referred earlier and you made some reference 
to this business of treatment for nausea. And his comment was to 
the effect that ill patients who were nauseated were not given nau- 
sea treatment for up to three days, which was not the normal prac- 
tice, as he stated it. Would you repeat what you said earlier about 
that? 

Dr. Saenger. What I said earlier about that was that we asked 
the ward personnel and the attending people not to ask specifically 
are you nauseated, do you feel like vomiting, because we found, as 
I think many of us observe in raising children and so on, if you ask 
leading questions you very often elicit responses, particularly for 
things which are somewhat suggestible such as nausea and vomit- 
ing. 

On the other hand, we have taken a great deal of pride in the 
quality of our nursing care on the tumor wards of the General Hos- 
pital over a period of some 50 years that I have been associated 



285 

with that institution. And I can tell you at that these patients were 
not left all alone and completely neglected and so on. That is sim- 
ply not so. 

I think, on the other hand, you have to realize the situation of 
people who are desperately ill. They have very unpleasant things 
happen to them. They get sick. They throw up. They lose control 
of their bodily functions. They don't immediately always have 
someone to come and clean them up. And when family members 
come in and see them in these rather sad states, everybody gets 
pretty upset. And I have had this personal experience with mem- 
bers of my family, and I am sure all of you have. 

But these patients under no consideration were abandoned or left 
out in a field and so on. It is just not so. That is not the quality 
of medical care that has been given in our institution during my 
entire career, earlier or later. 

Mr. Bryant. If a patient was nauseated, were they given anti- 
nausea medication? 

Dr. Saenger. If they complained. All they had to do was say, I 
don't feel good, and the patients were given whatever therapy — I 
mean, whether it was Compazine or some other antiemetic or 
cracked ice. 

Mr. Bryant. So your only policy in this regard was don't go and 
ask them? 

Dr. Saenger. Just don't ask the leading question. That was the 
only thing that we requested. And we only requested that for a pe- 
riod of 3 or 4 days. This was not something that would go on for 
a period of weeks. 

Mr. Bryant. So for a period of 3 or 4 days, during their course 
of these whole body 

Dr. Saenger. Immediately after the irradiation. Immediately 
after the total body irradiation. 

Mr. Bryant. You made reference also to psychological isolation 
of the patient. Do you recall any instructions that the patients be 
put in rooms all by themselves and left alone? 

Dr. Saenger. I do not recall that specific incident. The wards in 
which the patient were hospitalized were at that time generally 
open wards. There would be maybe anjrwhere from 2 to 5 to 10 
beds on these wards, more or less. 

It was the custom from the time I was an intern when a patient 
became critically and terminally ill, having a lot of things going on, 
if there was a single room in the wards of the hospital the patient 
sometimes was moved in it for two reasons: one, that the family 
could be there, that they could get some care from the family and 
from the nurses; and also so they would not disturb the other pa- 
tients who were less sick on the ward. 

That was the general, I guess, nursing practice at the hospital. 

Mr. Bryant. But that would be, I assume, the policy for all pa- 
tients at all times, would it not? 

Dr. Saenger. That is my impression. I don't think there was 
anything particular — I think the patients that we treated were 
treated as well, hopefully better, than any other patient in the hos- 
pital but certainly not less well. They were certainly not isolated 
or disregarded. 



286 

Mr. Bryant. Finally, the reference to what the Defense Depart- 
ment paid for. I don't understand how you segregate the different 
parts of this treatment. A patient is ill, has what you diagnose as 
termmal cancer, and they are given whole body radiation treat- 
nient, which they are informed in advance is experimental. What 
did the Defense Department pay for? 

Dr. Saenger. What was the DOD getting? 

Mr. Bryant. Not what were they getting. What were they paying 

Dr. Saenger. What they were paying for was a detailed observa- 
tion of the progression of the manifestations of radiation, the mani- 
festations that could be related to radiation such as nausea, vomit- 
ing, diarrhea, weakness and so on, and for a long string of labora- 
tory tests which are included in the material which you have in one 
of the appendices. 

Mr. Bryant. The cost of hospitalization and cost of treat- 
ment 

Dr. Saenger [continuing]. Was not paid for by DOD. In other 
words, in those days, as I recall, at General Hospital, you would 
come in and you would be charged, say, $100 a day that would 
cover everything that happened to you. You did not have these 
rather elaborate accounting systems that we have in hospitals 
today. 

That money was paid by the General Hospital. That was part 
of— the General Hospital was supported at that time by the general 
revenues of the city of Cincinnati. And they allotted so much 
money and then you could apportion that by what was 

Mr. Bryant. What portion of the treatment was funded by the 
Department of Defense? 

Dr. Saenger. No portion of the treatment was funded by the De- 
partment of Defense. If a patient got penicillin because of an infec- 
tion, if they got intravenous fluids, if the patient had to have an 
infected area operated upon, et cetera, if the patient was irradi- 
ated, that was not paid for by DOD. 

Mr. Bryant. You had a grant from DOD 

Dr. Saenger. The grant paid for statisticians— I am sorry— for 
clerical people, technologists, doing laboratory tests, some super- 
visory care by various Ph.D.s. I think occasionally M.D.s would get 
some small funds in that regard, but the treating physicians were 
not paid by DOD. 

Mr. Bryant. Therefore, the U.S. Government, through the De- 
partment of Defense, played a role in this only insofar as they 
funded research on the results of the treatment which otherwise 
were paid for by the hospital; is that correct? 

Dr. Saenger. I think you stated probably better than I did. 

Mr. Bryant. Was my statement correct? 

Dr. Saenger. I think it is correct. Yes, sir. 

Mr. Bryant. Mr. Mann. 

Mr. Mann. Dr. Saenger, just continuing in that same line, you 
stated a few moments ago that the Pentagon funding in no way in- 
fluenced the study. The study would have taken place either way. 
My understanding 

Dr. Saenger. The therapy. 



287 

Mr. Mann. Yes, sir. My understanding is that the course of ther- 
apy, the application of radiation, whole body radiation of these tu- 
mors, did not, in fact, start before the Pentagon funding and, in 
fact, stopped when the Pentagon funding stopped; isn't that true? 

Dr. Saenger. The therapy did not start before the DOD funding. 

By the time we got all of our activities in place, the tests and 
so on, we wanted to train our technologists, train our physicians 
and so on, in what we wanted to do, it took about a year to get 
ourselves together. 

Now, since 1970, or 1971 when the project was terminated, we 
somehow in our records cannot find what was done in total body 
radiation and partial body radiation in our hospital until 1979. 
From 1979 on, this form of therapy was used in a variety of condi- 
tions, which I described in my presentation. So that — ^we do have 
a gap in that period which is mostly one of recovery of records, so 
I can't answer your question from 1970 to 1979. 

From 1979 on, these patients weren't treated. 

Mr. Mann. So the use of whole body radiation in treating pa- 
tients at U.C. did not begin until the Pentagon funding began. And 
we have no evidence that between 1971, when the Pentagon began 
funding the program, and when your participation in that program 
ended in 1979, that whole body radiation was continued. 

Dr. Saenger. I can't answer that. From 1979 on, this method of 
therapy was continued. 

Mr. Mann. We have no evidence, so we don't know. 

Dr. Saenger. That is right. 

Mr. Mann. Now, earlier with Dr. Soper we were talking about 
the difference between solicited and unsolicited proposals. Had 
there been discussions with DOD before you submitted a formal 
proposal? 

Dr. Saenger. I believe we had had discussions, but I don't have 
any documents for that. Our proposal was considered in the cat- 
egory which was in common parlance then as an unsolicited pro- 
posal. In other words, they did not come to me and say. Dr. 
Saenger, will you consider to do the things that we did? I said to 
them, I think we can find information which will be of help to you 
in this particular thing, as we described in the proposals. 

Mr. Mann. I want to refer to the report that was done by the 
American College of Radiologists which talked about the fact that 
the number of cancer patients at Cincinnati General Hospital who 
are suitable for an aggressive palliation study have limited the size 
of the group under investigation. Do you agree with that state- 
ment? 

Dr. Saenger. Yes, I do. 

Mr. Mann. Now, given that the purpose of this research, as you 
have indicated to us, in your opinion was to advance medical 
knowledge and so forth and it also held out some benefit, you told 
us, for patients that had the opportunity to participate, did you 
ever make an attempt to find suitable patients who met the criteria 
of the work with other hospitals in Cincinnati? 

Dr. Saenger. We did not — no, we did not go to other hospitals. 

Mr. Mann. Is there a reason for that? 

Dr. Saenger. In getting our patients, you may recall that we 
said — ^the patients were referred to us. Now, by the time the pa- 



288 

tient got to us, the patient was considered for chemotherapy, per- 
haps for surgery, perhaps for no therapy whatsoever. And so we got 
a limited group of patients finally into the study. 

And even after that about, roughly, a quarter of the patients who 
were admitted into the study, we never did treat for various rea- 
sons, as I mentioned. Either we didn't think after we analyzed 
them and worked them up that they would benefit from the treat- 
ment or we should treat them otherwise or they declined. There 
was always the option that the patient could withdraw from the 
study. 

Mr. Mann. I guess my point is if this was a therapy that held 
out hope or advance for a patient who participated and then, from 
the standpoint of your research goals, it would have been helpful 
to have more patients. I am not sure I understand why you weren't 
making the program in which you were known to the other hos- 
pitals in Cincinnati so that patients who meet the criteria could be 
asked to participate. This would deal with the concerns expressed 
about the demographics of this population. 

Dr. Saenger. In looking over our records it appears there were 
five private patients who were referred and then became part of 
the General Hospital study. They did come from private physicians. 

Mr. Mann. Holmes Hospital or 

Dr. Saenger. I think one or two were from Holmes. Another two 
or three were from outside and were admitted to the service of the 
General Hospital. 

Mr. Mann. Five out of the 88 

Dr. Saenger. Then the three children, too. 

Mr. Mann. They are included in the five or in addition to the 
five? 

Dr. Saenger. In addition to the five. 

Mr. Mann. So five adults and three children. 

Dr. Saenger. We did not have a vigorous solicitation campaign. 
You know, if you take the 88 patients whom we treated over a pe- 
riod of 10 years, at eight patients a year we are not — I mean, this 
isn't a tremendous — I mean, this is not what we would consider a 
very high volume of people being studied. 

Mr. Mann. Let me go back to some of the things that others have 
said and just ask you to comment. 

In the ad hoc committee report chaired by Dr. Suskind, the state- 
ment is made on page 59 that, prior to 1966, the design of the 
study to measure the palliative effects of whole body radiation or 
partial body radiation was unstructured and not uniformly applied, 
particularly as regards uniform definition and methods of report- 
ing. 

Do you disagree with that statement? 

Dr. Saenger. I would say there is nothing that we did in the 
study that couldn't have been improved. We were trying to improve 
it as we went along. Statements like that — I think our Human Re- 
search Committee had made some comments along that line. We 
tried to improve the recording of palliative effects. 

Mr. Mann. Similar statements are made on page 61 and page 64. 

Of course, this speaks to the point that Dr. Egilman was making, 
that these design problems make it difficult now to — or at the time 
it made it difficult to measure what you were accomplishing from 



289 

a palliative perspective. He would argue — I guess that supports his 
conclusion that that was never much of a purpose at all. 

Do you care to comment on that point? 

Dr. Saenger. Well, I have participated over my career in design- 
ing quite a few studies, some of them interinstitutional, some of 
them involving tens of thousands of patients, and the problem of 
designing studies is always a very difficult one. 

There have been a number of critics of our studies who point out 
the deficiencies in the design, and I myself always have had prob- 
lems in saying that the design is adequate or inadequate to some 
degree, and it is something to which all of us have to suffer. We 
have to improve our design and so on. And I can't disagree with 
what Dr. Suskind's committee said. 

All I can say is that our design was the best we could do at the 
time, and, you know, in retrospective it may or may not have been 
inadequate. I thought the information we got out of it in the final 
analysis was pretty good. Whether it was as good as other people 
might have done, that is an individual matter. 

Mr. Mann. Dr. Gaffne^s letter was read at length by Dr. 
Egilman. Do you know who T. Gaffney is? 

Dr. Saenger. Yes, I do. 

Mr. Mann. I take it he was involved in the review that UC con- 
ducted of the bone marrow transplant aspect of the project. Is that 
your understanding? 

Dr. Saenger. I am sorry? 

Mr. Mann. My understanding is — I was asking if it is true that 
Dr. Gaffney was involved in the UC review of the bone marrow 
transplant part of the project. Is that true? 

Dr. Saenger. I don't know what you are quoting from. If you say 
it is true, I don't know — I wouldn't dispute he was involved. 

I would only say this. If you look at all the comments that were 
made by — the fact that the research committee at that time, they 
at no time disapproved our project. In 1971, at the time that the 
president of the university terminated the DOD contract, we re- 
ceived a letter of approval from the faculty research committee and 
from the dean of the medical school, so that we must have done 
something that was right. 

None of these things — this problem of determining this 
autologous bone marrow reinfusion. We worked on that from 1964 
until 1968 until we got some good results. This was at the very 
early stages of these techniques, at least at our institution. 

Mr. Mann. Thank you. Dr. Saenger. 

Mr. Bryant. Mr. Portman. 

Mr. Portman. I just have a few additional questions really relat- 
ed primarily to DOD's role. 

We have heard different analyses of the DOD funding. It seems 
to me that Chairman Bryant has gone into that in enough detail. 
But my question is, what percent, if you could tell us — and perhaps 
you don't know this off the top of your head — but what percent of 
the total funding for the project, the $651,400, came from the De- 
partment of Defense? 

Dr. Saenger. Are you talking about the combination of therapy 
and the DOD? 

Mr. Portman. Yes. 



290 

Dr. Saenger. We estimated — this is a very crude estimate — I 
think it would be some $416,000. I gave a figure— I don't want to 
contradict myself, but 

Mr. PORTMAN. $43,422 

Dr. Saenger. $483,000. I don't want to tell you this is the best 
estimate I could possibly make. 

In terms of the General Hospital at that period of time, our ac- 
counting system was, to say the least, rudimentary, and we made 
an estimate based on the average cost of a hospital day and then 
we added on some figures because of the additional cost for the ra- 
diation therapy and extra — some additional medication and so on, 
multiplied it by the number of patients, and that is how you got 
the number. 

But I must tell you it was a very crude figure. If you take that, 
the $483,000 and the $650,000, it comes to about a million one and 
whatever fraction 

Mr. PoRTMAN. Almost 40 percent. 

Dr. Saenger. Forty percent one, 60 percent the other. 

Mr. PORTMAN. But the figure of $483,000 does not include physi- 
cians costs or professional fees 

Dr. Saenger. I want to clarify that all of us who worked at the 
General Hospital were on salary. Whether I treated one of the pa- 
tients you heard about this morning or I treated you, I was neither 
richer nor poorer for this service. We were on straight salary. 
Whatever we did was part of the job. 

Mr. PORTMAN. The second question on the DOD side is, to the 
extent patients were told about the military uses of the data that 
was being compiled, how much were people told and when were 
they told of the military use of the data? 

Dr. Saenger. This was really sort of a mixed bag. We had asked, 
along with not asking about nausea and vomiting, the patients 
were not told, to my knowledge, were not told that they were 
being — that this information was being used by the Department of 
Defense. 

Unbeknownst to me, several of the physicians who were attend- 
ing the patients and obtaining the informed consent had mentioned 
to these that there may be some use of the information for prob- 
lems in a radiation accident. So that there was some knowledge. 

Now, this is by word of mouth, as the informed consents were, 
and we cannot document this in writing. They were told of the 
risks. It was only, I think, in about 1967 or so that mention was 
made that this information would be used for people in the battle- 
field. So that this is somewhat » 

Now, you must understand that in terms of what other patients 
were told in other studies, there were no people, no patients to my 
knowledge, certainly in that era and even today who are told the 
funding source or necessarily what the purpose of the study was. 
That varies with different investigators. Perhaps today that is 
more explicit than it was. 

But, certainly, talking to many investigators in internal medi- 
cine, surgery and other fields, they never disclosed the funding 
source for some purpose of the study other than whatever it was 
they told the patient about the benefits and risks. 

Mr. Portman. Thank you. Dr. Saenger. 



291 

That is all I have, Mr. Chairman. 

Mr. Bryant. I just have a couple of final questions. 

You indicated that the proposal to have the Department of De- 
fense participate with you was unsolicited. How did you all know 
that the Department of Defense funds were available? 

Dr. Saenger. I am sure — again, I can't give you a firm answer, 
but I am sure that this developed from some conversations which 
I had with members of the Department of Defense saying this — 
these were my interests. And they said, well, you know, we are sort 
of interested in the same things you are interested in. And then I 
made my unsolicited proposal. 

Mr. Bryant. Were you searching for funding, calling a whole lot 
of agencies at once? How did you 

Dr. Saenger. In those days I think we were all searching for 
funding. This was a general problem, and I think it is true today. 
People are looking for funding. 

Mr. Bryant. Also, if the Department of Defense was really only 
buying results from you — and correct me if I am wrong but that is 
kind of what I read what you are saying as being — they weren't 
paying for any of this activity. They were paying for the lab work 
and for the studies and for the results of it. Is that correct? 

Dr. Saenger. Well, that is what — I don't understand your ques- 
tion. Congressman. 

Mr. Bryant. The actual administering of the treatment to these 
patients that has been the subject of controversy here today was 
paid for by the hospital. 

Dr. Saenger. By the hospital, right. 

Mr. Bryant. And as I understood what you said — I understood 
what you said to be that the Department of Defense was paying for 
results, in effect. 

Dr. Saenger. Well, we weren't guaranteeing them results. We 
were trying to elicit changes, either biochemical or chromosomes, 
blood counts, et cetera, et cetera, that we thought we could predict 
knowing what the effects of radiation might be. And, as you can 
see, we tried a number of different things. 

We did not guarantee them — or, for instance, let's say we had a 
contract to build an airplane. We would guarantee at some period 
the plane would be available. But this was a research in which the 
outcome was not a guaranteed 

Mr. Bryant. I didn't mean to imply results — pay you to accom- 
plish a stated goal. I mean to pay for the results of the information, 
the findings from this work. That is what they were paying for, is 
that correct? 

Dr. Saenger. Yes, that is what we put in our reports. 

Mr. Bryant. I am curious why they made their payments over 
a 10-year period — on an annual basis over a 10-year period. I just 
wondered if that is consistent with that explanation. 

Dr. Saenger. There were contracts. We submitted new proposals 
as our work developed. We submitted new proposals. We got — we 
stopped doing certain tests. We instituted new tests. We instituted 
this whole program of psychological and psychiatric testing and so 
on. 

And the project gradually changed. We finally got into some as- 
pects of the bone marrow preservation and so on. 



292 

I mean, this was a changing project. It wasn't a static proposal. 
1 don t know if I am answering your question. 

Mr. Bryant. Dr. Saenger, thank you very much for appearing 
today and testifying on this matter. 

We would like to express our thanks once again to Judge Weber 
and his staff for making the courtroom available to us and all of 
those who have been helpful in making this hearing a success. 

With that, the subcommittee hearing is adjourned. 

[Whereupon, at 2:55 p.m., the subcommittee adjourned.] 



APPENDIX 



Material Submitted for the Hearing 

The Testimony of Gloria Nelson 



AMBLXA JllCXSOH 
PATIBST NO - C7 



on October 21, 1966, after being discharged for General Hospital, 
Ms Jackson %ras a very weak ill woman. She was unable to take 
care of herself properly, and depended on the family for all her 
basic needs. She expezienced bleeding from her rectum, loss of 
appetite, nausea, vomiting, weight loss, and was in coi#tant 
pain. Her condition nc.ver improved. 

Within a few weeks she was readmitted to General Hospital. The 
family was informed 8h<» should be transferred to Drake Hospital. 
Ms Jackson indicated she wets afraid and wanted to return home. 
She was transported hone, where she was loved and cared for by us 
until she died on Mardi 25, 1967. 

The family of Amelia Xickson would like for this committee to 
know, that for the entire 163 days after receiving the 
irradiation, her condition continued to deteriorate. We feel 
that the 100 rads of partial-body irradiation administered to her 
was cruel and didn't help her condition in any way. It's our 
belief that she may have lived longer if this experiment had not 
taken place. 

A doctor is someone you trust. His job is to do everything in his 
power to alleviate your pain and suffering. However, this was not 
the case. She was alvays crying, moeming, groaning, and in 
excruciating pain. Ma_Jaj;3cson y^s used to further JDr*. Saeger Is.- 
^igo f es s i onal.^gal8 . - - It was purely an eunbitious and. callous act, 
^NeT^ er'Ms Jackson noi- the family were informed or consented to 
^jher ^ing_used in an experiment iconducted by Dr. -Saeger^And 
'^jfunded by^the IJepartmemt of .Defense.. ..There has clearly been a 
cover up by means of i-Jh& Government, General Hospital, Dr. Saeger 
amd City of Cincinnat:.. We cannot believe that they consented to 
such atrocities to be financed by the government; utilizing Ms 
Jackson's and the faa:Lly's tax paying dollars. 

(293) 



# 



294 

The Testimony of Joe Larkins 
April 11, 1994 



My name is Joe P. Larkins. I am now 52 years old. My Father, 
Willard L. Larkins, passed away in 1971. I was 30 years old 
at the time. My family consisted of myself, an older sister 
and my parents. When my Father passed away, he and my Mother 
were in the process of raising a grandchild (my sister's 
son). Neither of my patents were well-educated, but my 
WPCher was hard-working and honest. We always had clean and 
decent clothes to go to school in and we always had ample 
food on the table. It doesn't take a well-educated person to 
be hard-working or honest. If Cincinnati General Hospital 
and the Doctor's therein had been honest, there is of 
course, the possibility that_my Father could have lived for 
e;f.vR|-j^] _mor"fe "yearST Instead, TTe went 'from a " fairly 
able-bodied middle-aged Father and Husband to a premature 
death caused by an "experiment" . My Father did not kno w that 

Jie was b eing u sed as a guinea pig ^__my_fJotber. did not kn ow; 
as his children, we were not inforBied of . juhe- ^roo edur es — to 

"Be usea noT 6f "the risks involved. 



I feel as though Dr . Saenger and the other 
"Doctors "involved, if you will, knew that the high levels of 
radiation which they administered to these patients had the 
very real probability of being fatal. Oh, how right that is! 
My Father was very much a family man, yet these people 
killeid him as surely as if they had put a gun to his head 
and pulled the proverbial trigger. These "Doctors" left my 
Mother, with no job skills, to raise a grandchild as best as 
she could. My Mother lived until 1983, but she was a broken 
woman after my Father ' s premature and unexpected death . 



I know that my Father knew that something was very wrong 
with the treatments being given to him at Cincinnati 
General. He even asked me "Son, what are they doing to me? 
They're trying to kill me!" That's how bad the pain' he 
endured after the treatment was. He suffered so needlessly. 
What really gets me about this situation is the fact that 
the Pentagon contracted with these Doctors and this hospital 
to test the effects of radiation on the human body. Everyone 
realizes that Cincinnati General , Hospital, now the 
University of Cincinnati Hospital, treated many 
low-education, low- income patients. I guess they felt that 
in some way, the fact that these patients were not rich, 
upper-class citizens, gave them the right to experiment with 



295 



their bodies without informed consent. NOT SO! I feel sure 
these physician/researchers were well-paid for their part 
and it would be very interesting to know the types and 
dollar amounts of the grants given to Cincinnati General by 
the Federal government. I feel sure that all parties, with 
the exception of the poor, unsuspecting patients and their 
families, were well-compensated. But since when, in our 
society, does one man or even a group of them, have the 
right to play God? A very good example of this is our 20th 
century "assisted suicide Doctor". This man is contacted by 
terminally-ill patients who wish to end their own lives with 
dignity and choose, by their own voilition, not to suffer 
needlessly for years. These people make the decision to die 
in peace, yet our great judicial system, along with the 
medical community, brought this compassionate physician up 
on charges. The differences in these deaths and the death of 
my Father are that my Father did not choose to die - someone 
else made that decision for him, without consulting or 
informing him and they were amply compensated for it. I ff^el 
that the price they should be required to pay to the 
families of the people they killed, should be exceedingly 
high. I also feel that the Federal government should be 
named as a co-conspirator in this case, because that's 
exactly what it was - a conspiracy. No person, and I 
emphsize 'NO', person would willingly consent to a treatment 
with any degree of fatality involved. People, both you and 
I, simply value life too much. I think that is the big thing 
here - the patients were not informed. I know that behavior 
of this sort would not be tolerated by the medical community 
today. But then again, this entire mess was surrounded by a 
thick veil of secrecy on both the doctors' part and on the 
part of Cincinnati General Hospital. It is still being 
closely guarded and kept under yet another veil of secrecy 
to this very day by the University of Cincinnati, in that 
they have yet to provide the medical records of the patients 
involved in this experiment/ I beseige you to order the 
University of Cincinnati to release the patient records, in 
their entirety, to the next of kin immediately. They are 
hedging to save their own skin. I was promised my Father's 
complete medical file over a month ago; as of this writing, 
I have nothing. 



I only hope that you, the Congressional Committee, see fit, 
as members of the human race, to break this matter wide open 
here and now and award just compensation to the families of, 
the victims. I feel that the Physicians involved and also 
the federal government (the Pentagon) should pay and also I 
beg you to strip any and all of the Doctors involved of all 
their medical credentials that they hold. If justice 
prevails in this matter, and I have faith that it will, a 
strong message will be sent to our government officials and 
the private physicians (to whom people entrust their lives 
and the lives of their loved ones) that behavior of this 



296 



sort will simple/ not be tolerated, that justice will in 
fact be both swift and severe. I pray that a situation auch 
js thic wil] ntver ad-ai-U be foLC^u by a group of people. If 
this statement to you, the Congressional Committee, does 
anything to help in the name of justice, then my Father's 
death and the sorrow and hardships that his familty faced, 
will not have been completely in vain. 



Thank you. 



297 



Ms. Catherine O. Hager 
590 Delta Avenue 
Cincinnati, OH 45226 
513-871-8773 



April 7, 1994 



*V' 



To: Total Body Radiation Subcommittee and Whom it may concern;' 

In January, 1 994 I began noticing articles in The Cincinnati Enquirer regarding Total 
Body Radiation experimentation done on cancer patients in the 1 960's at Cincinnati 
General Hospital. Since I knew my father, Joseph Mitchell, was treated at that 
hospital for cancer during that period of time, I contacted Linda Reeves at The 
Cincinnati Enquirer. After a brief discussion with Linda, it was determined that my 
father had indeed been involved in the Total Body Radiation experimentation as patient 
#051 , the first patient to be identified. From this point, my husband and I, along with 
the assistance of the news media attempted to piece together any records available 
regarding my father's treatments at the hospital. 

In October, 1 963, my father was diagnosed with lung cancer in the right lung, and 
was admitted to Cincinnati General Hospital. Surgery was scheduled for November, 
1963. Although there is no notation of this scheduled surgery in his medical records, 
we have a letter which was written by my father to my sister detailing the planned 
operation. For some unk nown_regson the surgery was cance]ed.o.njhe_ day it was 

_jcli£dLiled to take placft,jiivith no expian^tig^^^jg^" surger y was never rescheduled. 

_!nsiefldL_mvJathfiLwas^ given j_sc_hedule oMates Jto return to the hos£JtalJor Cctbalt 

Treatments. At this point, I asked the doctor why^thesurgfiyjwasxanceletL.He^ol^ 

~~fne h e wainEo6" "v^"aR^'foT"sufgeryTnd decided to. opt-for the_CQhall„ Treatments 
_______ 



In reality, my father was not in a weakened state at that time but was in relatively 
good health, still working and living a normal life. It wasn't until the Cobalt 
Treatments started that my father began to go down hill. After 35 days of treatments 
my father was so weak that he had to retire from work and move closer to my family 
so we could help care for him. 

In early 1965, my father was again admitted to Cincinnati General Hospital with 
severe chest pains. It was at this time he was subjected to the Total Body Radiation. 
He immediately started on a drastic downhill spiral. After much suffering, my father 
died on July 14, 1965 - 74 days after the Total Body Radiation./ ^-t^p p 



298 



Total Body Radiation Subcommittee 
April 7. 1994 
Page 2 



Since Total Body Radiation had not been performed on cancer patients at Cincinnati 
General Hospital prior to the Government funding of 1 960, 1 feel that my father, along 
with other cancer patients, were hand picked and used in Total Body Radiation; not 
as a treatment for cancer, as they had been told, but as a cover-up for a study 
performed for the Department of Defense to determine possible effects on soldiers in 
nuclear warfare. 

It might be noted that at the time my father died, two of my brothers were in the U.S. 
Air Force. One in Vietnam in the war zone. The Red Cross had to locate him and 
bring him home for the funeral. Both brothers have since retired from the Air Force. 

Isn't it ironic that two of my brothers were serving this country in the military, while 
at the same time The United States Government was sponsoring experiments which 
shortened or ended their father's life. 



Respectfully, 

Catherine O. Hager (Mitchell) 

COH;cmh 

Enclosure 



299 






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300 












301 



A REPORT TO THE CAMPUS COMMUNITY , H ^^^L/JfJfA 

Since last October a committee of the Junior Faculfy Assoc- ^tl^iV^W 
iation of the University of Cincinnati has been investigatin^^iMM^^^ 
the radiation experiments at the University Medical Center. ^|^^L^^ 
We have interviewed doctors involved, and we have studied m/Ml^M^^' 
with care the reports of the research team to the Defense ^^^ 
Department, as well as the team's publications on radiation^^ ^ 
in medical journals, and many other pertinent documents. I |^«*li 
Our committee has had extensive help from members of the ^4^ 
medical community. I^") 2 J 

For reasons that we will present below, we have come to the 
conclusion that many patients in this project paid severely 
for their participation and often without even knowing that 
they were part of an experiment. We feel that the evidence 
clearly calls into question the manner in which these human 
experiments were designed and carried out. We therefore 
urge the president of the University to terminate this 
project and to instruct the Medical Center to cooperate 
fully with the congressional hearings to be held next month. 

We are addressing ourselves in this report to what we believe ^ffJ^f 
to be the three most crucial questions to be asked about Q^^t^^y 
this project: // JX# 

(1) Was cancer study the main object of the experiments? ^|M^^ 

(2) What were the real risks to the patients? €i|iy>^ 

(3) Did the patients give their informed consent to 
being used as experimental subjects? 

To begin with, we have been unable to find any evidence of 
a planned, systematic cancer study. It seems unlikely that 
the team would not have mentioned, somewhere in the 900 
pages of the Department of Defense (DOD) reports, the fact 
that they were conducting the DOD project in conjunction 
Kith a specific cancer research study, had this indeed been 
the case. Nor has tWe team made public, even during the 
recent months, a design for cancer study in any way comparable 
to the detailed proposals for DOD radiation studies, proposals 
which have been repeatedly and painstakingly modified and 
amplified over the eleven years of the project. 

We also point out that there is no evidence in the DOD 
reports that any patients were irradiated before the beginning 
of the DOD project in February 1960; the two projects, 
research on cancer and research on radiation injury (if 
indeed there were "two"), seem to have been coterminous. 




^ 



302 



Consistently throughout the reports to the DOD the doctors 
make statements that indicate that the selection of patients 
and the radiation dose given them was at least partly 
tailored to the needs of the DOD project. For instance, we 
find that in the first description of their project the 
team states that they will generally not irradiate women 
with active menstrual cycles. The menstrual cycle, they 
say, affects the appearance of amino acids in the urine and 
at this time the team is studying amino acids in the urine 
of irradiated subjects in hopes of finding an indicator for 
radiation injury. Such a statement as the following, which 
appears in the 1970 report, points clearly to the fact that 
the main reason for increasing the dose over the years was 
to improve the data--not on cancer treatraent--but on radia- 
tion injury: 

Clearly much more in vivo data are required [for 
indicator studies] with good dosimetry [where the 
radiation exposure can be controlled J. We are 
pursuing this goal at whole-body radiation doses up 
to 250 rads with even higher doses planned with the 
support of marrow auto-transfusion and laminar-flow 
"sterile" rooms. Large-volume partial-body irradi- 
ation is also being performed to learn more about 
the efficacy of chromosome aberrations as a radi- 
ation dosimeter. . . . [1970, page 22] 

Also, consider the wording in this initial sentence of a 
1964 publication on dosimeters by the Saenger team in 
Radiation Research : "In an effort to evaluate the metabolic 
effects of single doses of whole body radiation in the 
human being, patients able to maintain their nutrition with 
disseminated neoplasms were given therapeutic doses of 
whole body radiation with Cobalt-60 teletherapy." And in 
the 1971 DOD report we find these particularly chilling 
lines : 

This [report] brings to 43 the total number of 
patients who have undergone assessment for the effects 
of total or partial body irradiation on their cogni- 
tive-intellectual functioning and emotional reactions. 
In terms of the characteristics of the overall sample", 
the addition of the new patients will serve to improve 
the ratio of whites to Negroes, to increase slightly 
the average educational attainment, and to decrease 
the average age. The trend noted in the 1969-70 
report toward recruiting patients in comparatively 
better physical condition has continued. 

[1971, page 72] 

Finally, we repeat the now rather well-known fact that there 
has been no publication by this team specifically on total 



303 



or partial body radiation as cancer treatment. One of the 
doctors, Dr. Edward Silberstein, wrote to the chairman of 
the JFA committee last November 14 as follows: 

I hope I made clear to you on Monday that we have 
not yet published the results of therapy because of 
the variable duration of patients' clinical course 
with cancer following treatment and the need to have 
an adequate sample of patients before one makes any 
statements about the efficacy of one's therapy. 
Since I am limited to treating 7 or 8 patients a 
year, I cannot, as a responsible scientist, issue 
claims about what we can do therapeutically for 
patients over a short period of time. 

Is it conceivable that in an authentic cancer research study, 
no results would be reported after eleven years and the 
radiation of 87 patients? If no pattern had emerged after 
the irradiation of 87 patients--indeed after 10 or 20-- 
would this in itself not have been worth communicating to 
other cancer specialists? We also question why, if this 
were a serious study of the effects of radiation on cancer, 
so few autopsies were performed. 

We can only conclude that the purpose of irradiating cancer 
patients at General Hospital was primarily to study radiation 
injury for the DOD and that incurable cancer patients were 
used because (a) they were going to die anyway and (b) they 
"might" benefit from the radiation in terms of reducing pain 
or slowing the spread of cancer. 

We move now to the question of the real risks to the patients 
and the effects on them of the radiation. We begin with 
this crucial statistic: o_f the 37 irradiated subjects whose 
histories are given in the DOD reports . 21 died within 38 
days --or 24% . 

What is even more serious is that of the first 40 patients 
given total-body radiation before the advent of bone marrow 
transplants, 7 of the 18 receiving the higher doses (150 
or 200 rads) died within 38 days--or 39%. That the higher 
doses were much more lethal than the lower doses is clearly 
borne out by the fact that of the 22 patients receiving 
100 rads or under, only lOX succumbed within the 38-day 
period. The full statistics on this early period of the 
project, as we have abstracted them from the reports, are 
as follows: 



304 



First 40 total - body subjects ( 1960 - 66 ) : 

Of those receiving 200 rads , 2 of 6 died within 38 days 

150 rads, 5 of 12 

100 rads, 1 of 14 

"under 100 rads, 1 of 8 

150 rads or over: 7 of 18 
under 150 rads: 2 of 22 



Of the total 87 patients, it may be added that 4 died within 
10 days, 7 within 20 days. 

These statistics are all the more alarming when one juxta- 
poses them with the doctors' descriptions of the patients 
at the time of radiation. Throughout the DOD documents the 
doctors report that though all their subjects are patients 
with incurable cancer they are not in the final stages of 
disease or close to death. Patients as a group are described 
over and over again as having "relatively good nutritional 
status," "normal renal function," and "stable hemograms." 
We offer this sentence from the DOD report of 1969: "The 
patients who are irradiated, all of whom have inoperable, 
metastatic carcinoma but are ^ji relatively good health , 
provide us with an opportunity to study multiple facets of 
the effects of radiation in man rather than in experimental 
animals," (page 1). In the 1970 report the doctors write: 

Several of the subjects were tumour-free and 
essentially normal (following radiation-induced 
tumour regression) receiving prophylactic whole- 
body radiation. The rest had metastatic carcinomas 
which were inoperable and not amenable to conven- 
tional chemotherapy. Nevertheless, these patients 
were all clinically stable, many of them working 
daily . "Tl970, page 2 J 

Even of the group described above, 2 died within a month-- 
one on day 31 and one on day 22. 

In regard to possible benefits, we assume that any benefits 
that would balance out these enormous rislcs would have to 
be very plain and dramatic. Yet this is not at all the 
case. The American College of Radiology (ACR) team stated 
that about a third of the patients reported a decrease of 
pain (the medical histories show, by the way, that some 
patients had an increase of pain following radiation) and a 
greater "sense of well-being" and that a third had decrease 
in primary tumor size. Dr. Saenger has said that he feels 
the statistics for long-term survivors--a small number of 
patients lived several years after radiation--will show 



305 



that total and partial body radiation is "promising" as 
cancer treatment. But even that much is clouded by (a) the 
fact that many subjects received other kinds of therapy 
before or after radiation and (b) the fact that the Saenger 
team used no control group. The doctors state in the later 
DOD reports that they are carrying out their experiments in 
conformity with the Helsinki Code (which dates from 1964) ; 
yet the code clearly states that the health of the patient 
must always be the first consideration in trying out new 
kinds of therapy: 

1.4. Every clinical research project should be 
preceded by careful assessment of inherent risks 
in comparison to foreseeable benefits to the subject 
or to others. 

But let us assume for the moment that those we address are 
not convinced, even by the number of short survivors plus 
the patients' conditions at time of radiation, that many 
died of radiation injury rather than simply from their 
disease. There is yet another kind of evidence that radia- 
tion injury was a major cause of death. It has been known 
for some time that a major injurious effect of radiation is 
bone marrow failure. The bone marrow's ability to make white 
and red blood cells can begin to fail as early as 6 days 
post radiation; the critical period for marrow failure then 
comes from 25 to 40 days post radiation. In summarizing 
in 1966 the marrow problems for their first fifty patients, 
the doctors themselves make the following statement: "The 
total white count falls to a low point 25 to 40 days after 
irradiation. There was a persistent lymphopenia which 
persisted for 40 to 60 days" (page 31). Can it be merely a 
coincidence that the short survivors are bunched in exactly 
that critical 25-40-day period? — that, for instance, no 
less than 9 subjects died from 31-38 days? In this same 
1966 report, in fact, the doctors state outright that 
"severe hematologic depression was found in most patients 
who expired," and they note that because of this, they are 
beginning work on bone marrow transplants--f ar too late, in 
our opinion. In the 1963 rep>ort, they write that "Delin- 
eation of disease score [a rating for blood problems), 
radiation score [the rating adjusted after radiation] and 
total continued to be of value in ascribing the importance 
of radiation in precipitating demise " (page 9) . 

A distressing aspect of the doctors' public disclosures 
about this project has been their misleading statements 
concerning the protection given the patients by bone marrow 
transplants. It has not been made clear that of the first 
50 patients only 2 received transplants and that neither of 
these transplants was a clear success (the first subject 
died, in spite of the infusion, 28 days post radiation). 



306 



The team from the American College of Radiology reported 
that it felt the research team could not be censured for 
not giving bone marrow transplants during the early years 
for the simple reason that the technique had not then been 
perfected. But since the doctors could not protect the 
patients from bone marrow failure, were they justified in 
giving the higher doses of radiation? Among those first 
50 patients, we point out again, 7 of the 18 high-dose 
subjects did not live beyond 38 days. 

Why did the doctors not discontinue high dose radiation as 
soon as tliey began to lose patients from bone marrow failure? 
It is perfectly clear that in the first six years of the 
project, the less radiation given the better the patient was 
likely to do. It has, in fact, only been within the last 
year or so that the doctors have had much success with the 
transplants; it is still not completely clear that bone 
marrow transplants offer a certain way of protecting all 
patients. 

We move now to the third question: Did the patients give 
their informed consent to being used as experimental 
subjects? We note to begin with that during the first five 
years of the project no consent form seems to have been 
used at all; none is mentioned in the DOD reports for these 
years, and the absence of written consent is corroborated 
by the ACR. In fact, it is clear from the DOD reports 
that during these years the doctors were not attempting to 
justify the radiation as experimental cancer treatment but 
simply as "therapy" or "palliation treatment," as it is in 
these words that the radiation is constantly described. 
Patients seem to have been told nothing except that the 
radiation was part of their treatment. Over and over again 
in the reports we find such lines as these: 

The patient is told that he is to receive treatment 
to help his sickness. [1961, page 3] 

The patient is told that he is to receive treatment 
to help his disease. [1963, page 4j 

In 1965 a short consent form was initiated, but it made no 
mention of specific risks from radiation injury, merely 
asking the patient to state that "the risks involved" and 
"the possibility of complications" had been explained and 
that "the special study and research nature of this treat- 
ment has been discussed with me and is understood by me." 
For what the patients were told we have only the doctors' 
word. Another form, used as late as December 1970, states 
the risks as follows: "The chance of infection or mild 
bleeding to be treated with marrow transplant, drugs, or 
transfusion as needed," and the first line of that form 



\ 



307 



reads as follows: 

I (the subject) being of the age of majority and of 
sound mind and body, voluntarily and without force 
or duress, consent to participate in a scientific 
investigation which is not directed specifically to 
my own benefit . but in consideration for the expected 
advancement of medical knowledge, which may result 
for the benefit of mankind. 

The latest consent form, a revision of the above made last 
spring and signed by only a handful of patients, includes 
under "Risks" a long paragraph regarding bone marrow problems 
and alters the lead sentence to read " not only directed 
specifically to my own benefit, but also in consideration 
for the expected advancement of medical knowledge. ..." 
It IS a very unhappy fact that it was this last form, only 
in use for a few months, that Dr. Edward Gall, director of 
the Medical Center, chose to release to the newspapers. 
This form was printed entire in the Cincinnati Post . with a 
statement saying it was signed by "every adult patient" of 
the project. 

In our view none of the consent forms properly states the 
real risk to the patients--that is, the risk of death from 
bone marrow failure within 40 days. We feel, in fact, that 
no conceivable consent form, particularly in view of the 
subjects' low level of education, would have justified the 
doctors in subjecting the patients to the higher doses of 
radiation. 

In conclusion, we want to comment on the recent report by 
the American College of Radiology, which finds nothing 
whatever to criticize in these experiments and urges that 
they be continued. We are confident that this report will 
not be taken seriously by anyone properly informed about 
this project. The ACR omits from their report the more 
damaging statistics on patient survival. The only statistic 
they give is as follows: "A group of 10 per cent or eight 
patients died from 20 to 60 days after the whole body expo- 
sure." We find 14 total-body subjects who died within this 
period (not to mention 5 partial-body ) --or 22%, and of course 
this figure takes no account of the 7 subjects who died 
within the first 20 days. The ACR doctors contribute, in 
other words, to the deceptive impression that the main side 
effects from radiation were nausea and vomiting within the 
first few days. 

As for the special committee appointed by the president, we 
regret very much that the existence of such a committee' was 
kept secret for so long and that even today the names of the 
committee members have not been revealed. It has been 



308 



8 

impossible for us, or any other party interested in the 
project or having special information about it, to communi- 
cate with the committee. We hope that even in this unprom- 
ising context, however, the committee will seriously address 
itself to the real questions surrounding this project and 
will make a recommendation that we all can support. 

The Junior Faculty Association committee has not been secret, 
and we have asked in the campus newspaper for the assistance 
of all interested parties. We also succeeded finally in 
having a full set of the DOD reports made available in the 
reference room of the UC library for all to inspect, and 
all are invited to check our facts and figures in these 
public documents. 

We are confident that those who examine the evidence for 
themselves will join with us in urging the president to 
terminate this project and to assure the public that the 
Medical Center will make a full disclosure of all the facts 
at the congressional hearings. 



Printed at JFA expense. 



309 



Date: April 4, 1994 

To: Robert B. Newman, Attorney at Law 

From: Members of the Maude Jacobs Family 

Subject: Radiation Testing at UC (Cincinnati General Hospital) 

This correspondence is regarding Maude Jacobs, a female Caucasian, 
who was an unsuspecting victim cf the radiation tests conducted by 
the University of Cincinnati. Maude was born in Whitesburg, 
Kentucky on June 7, 1916. The third grade was her final year of 
formal education. By the time she was thirteen years old, she was 
married and had given birth to her first child. She bore seven 
children in all, six girls and one son. She was a beautiful woman 
with a lovely radiant smile. She was impeccable about her 
children's appearance, as well as her own. Her devotion to her 
family was obvious to anyone who knew her. Maude lived her life 
below the poverty level, but was a proud and dignified woman. She 
was genuinely happy with the simple things in life. Her delight 
was cooking and caring for her children. When she died she was a 
widow and left three minor children at home. 

According to information from CGH (Cincinnati General Hospital), 
Maude was diagnosed with breast cancer on July 17, 1964. A 
treatment of hexamethylmelamine began on July 27,1964 and was 
completed on August 18, 1964. With this medication her primary 
tumor receded markedly. On November 7, 1964 total body irradiation 
was administered. The midline absorbed tissue dose was 150 rad (250 
r midline air dose). At the termination of the treatment she had 
severe vomiting for twenty-four hours, in spite of intramuscular 
compazine. Before treatment she had a normal hemogram. Seven days 
after treatment the white blood count began to fall. The platelet 
count fell around fourteen days after treatment. The WBC was 1,000 
and platelet count was 80,000 twenty-three days after treatment. On 
the twenty-fourth day, the WBC was 850 and platelet count was 
38,000. Maude died December 2, 1964. Twenty-five days after total 
body irradiation. She was study number 045. (Documentation from CGH 
attached. ) 

Two letters written by Maude to her sister Arlie less than two 
months before her death describes how she felt, and also indicates 
she thought the doctors did not know what was wrong with her. She 
talks of living near her oldest daughter, Lillian, who is very 
helpful to Maude. She also is pleased to be home with her children, 
but feels sorry because she is too tired in the evenings after 
preparing dinner to watch television with them. She refers to the 
expense of her medication and said prayer helps her more than the 
doctors. These letters demonstrate her education level, but also 
reveal her devotion to her children. Maude had no knowledge of the 
seriousness of her cancer much less knowledge of the radiation 



310 



treatment. She did not expect to die. If she had, she would have 
discussed the future care of her minor daughters with the rest of 
the family. Her death was so sudden and unexpected the family was 
totally unprepared. The three young daughters eventually were put 
in St. Aloysius Orphanage. (The two letters from Maude to her 
sister are attached. ) 

The family was NEVER informed of the radiation test or it's 
purpose. Nor was anyone ever asked to sign a consent form or give 
verbal permission for testing. Some of the memories which were 
dismissed without attaching importance now make sense or at least 
raise suspicion. Her daughter Irene was seven months pregnant at 
the time and was having a difficult pregnancy. She remembers 
Maude's bright smile and cheerfulness, then remembers a private 
room and no more smiles or happy faces. Irene remembers being 
afraid of going into that room. Maude asked her to feel her head 
and when she did it felt full of soft tumors. Her body felt like 
sand. Even in the hallway she could hear Maude's delirious talk. 

Maude's daughter Sherry was twelve years old and remembers the 
private room, but at the time didn't know it was uncommon for a 
person without insurance. Sherry remembers the orphanage and being 
split up from her two younger sisters. The youngest girl, Kim, 
eventually went to a foster family. 

Robert Murphy, one of Maude's grandson's, remembers thinking how 
nice it was to have a private room without insurance. Bill Murphy, 
another grandson recalls visiting her in the private room, but not 
wondering why she was there. He remembers her conversation as "out 
of her head". 

Her oldest daughter, Lillian Murphy Pagano, lived downstairs from 
Maude and was her primary care provider. Lillian was never 
contacted or consulted about her mother's treatment. She remembers 
a drastic mood change associated with rapid physical deterioration. 
She too recalls the private room at the end. She remembers thinking 
her body felt like sand. She was concerned too for Irene, because 
of her pregnancy and the worsening of their mother's health so 
rapidly. Lillian's concern grew as Maude quickly became disoriented 
and no longer recognized anyone. She was violently ill and talking 
utter nonsense. Maude died before her time everyone felt. Her 
family lived for the next twenty-nine plus years with the sadness 
of her death, but also had warm memories to console them. 

Since the details of the experiments became public, the entire 
family has been drastically affected. Now guilt has replaced the 
sadness and comments like "I should have known" or "I should have 
asked" are commonplace. Reliving Maude's last days over and over, 
remembering differently now why she was so violently ill, how she 
suffered, and now a reason for the private room. Her death is now 
a nightmare. She died without comfort and dignity. She was 
discriminated against and selected because of her background. No 
benefit was ever planned for Maude. She was a number, a statistic. 



311 



Her children want an apology. They want to know nothing they could 
have done would have altered the results. They want Maude to know 
they are sorry if they disappointed her because she suffered 
needlessly without intervention from them. They also need a quick 
resolution so this too can be a memory. Already too much damage has 
been realized. 

Lillian Murphy Pagano (Maude's oldest daughter) feels personally 
responsible for her death. She became obsessed with Maude's death, 
often calling other family members several times a day to go over 
some part of her last days again and again. She was found several 
times at three or four o'clock in the morning with a fixed stare 
and silent sobs. Eventually she was rushed to the hospital with a 
suspected heart attack. After a short stay of a few days, some 
testing, several prescriptions, and instructions to avoid stressful 
situations, she was permitted to go home. Anxiety struck again 
within a few weeks. This time she was gone. Lillian's daughter 
found her, called 911, and received over the phone guidance for 
delivering CPR. When paramedics arrived, she was given multiple 
shock treatments to revive her. It is estimated she was dead for 
four minutes. She was on a respirator and in a coma; she also had 
several seizures. The doctor's gave her a 50% chance of pulling 
through, but warned all about the possibility of permanent brain 
damage. She has regained consciousness, but is still in critical 
condition at this writing. She recognizes family members, but is 
mentally unstable. The extent of damage is still unknown. Her 
family has been told she will need twenty- four care and cannot be 
exposed to ANY stressful situations. She doesn't talk about Maude 
now. She doesn't even remember who visited her an hour ago. 

The ordeal with the UC experiments must come to a swift conclusion. 
This is the saga of only one family, there is supposed to be 
eighty-seven more victims with families. It's amazing how something 
that was a remote, barely thought of memory, now is resurrected and 
grown into an unwelcome demanding problem. A problem that can 
consume your days and affect people from twenty-nine years of 
family growth people Maude never could have known. 

This letter was compiled from the hearts and thoughts of Maude 

Jacob's children: 

Lillian Murphy Pagano (nee Phillips) 

Irene Froman (nee Phillips) 

Bob Phillips 

Betty Wolfe (nee Phillips) 

Sherry Brabant (nee Jacobs) 

Janet Baker (nee Jacobs) 

Kim Swedo ( nee Jacobs) 



Attachments 



312 



My Aunt Louise Richmond passed away from Colon Cancer in March, 1968. She 
was only 49 years of age. My Mother Viola Macklin (one of Louise's older sister) 
brought her from Cleveland, Ohio to Cincinnati, Ohio for medical care of her cancer at 
the General Hospital. 

Instead of medical treatment, my Aunt Louise, unknowingly was used as an 
experimental subject at General Hospital in their radiation experiment. Within weeks of 
her admission, her health rapidly and painfully deteriorated and ultimately leading to her 
death. 

Regrettably, the news of the General Hospital Radiation experiment has recalled 
many agonizing memories for myself and my family. The death of a loved one, under 
normal circumstances is difficult, but now with the added knowledge of my Aunt 
sacrificial involvement in the radiation experiment, my family members must relive the 
misery, now with twice the anguish. 

Various family members can vividly recall the evening visits to the hospital as we 
accompanied our mother to visit Aunt Louise. The torturing cries of pain that greeted us 
as we entered into the hospital ward had become all to familiar to us. She would be 
lying in her hospital bed trembling and shaking from her agonizing pain so forcefully 
that the bed itself would be visibly vibrating. 

Throughout the visit, my Aunt Louise would cling on to my mother's arm crying 
and begging her to take her home. She would repeatedly say, "please Viola take me 
home with you, l['m in so much pain, they are hurting me, they are trying to kill me". 

The visits would always end with my mother tearing herself away from my Aunt 
Louise only to hear her cry in pleading desperation as we walked away. For seemly, 
hours after we left the hospital and even after reaching home my mother would cry from 
the guilt she felt for my Aunt's severe pain and suffering. My mother would routinely 
rock herself to sleep while crying and humming spiritual songs to relieve the 
burdensome feeling of her most recent experience/visit to my Aunt Louise. 

After my Aunt Louise' death in March, 1968, my mother would often ask us if 
they (the Doctors at General Hospital) were really giving her the correct treatments for 
cancer. 

We had no idea Aunt Louise was a part of a Defense Department experiment. 
We're sure if she had known she was a guinea pig, she would not have participated. 

My mother would often recall the visit and continued to blame herself for the 
pain and anguish my Aunt Louise had experienced. My mother carried this unwarranted 
guilt to her death, and now we have been forced to carry this guilt as well in memory of 
my mother and aunt. 






818 



TJp : Congressional Committee 
F^OM: Httben F. Varin 
DATE: April 4» 1994 



Study #075 N.C. 
Chart #CGH 409-278 

My mothers name was Nina L. Cline, a loving and caring mother, 
whose only hope was to see her grandchild before she died. She did 
10 months before her death. She was also very close to her sister, 
and her sisters children, who were all very helpful with my mother 
during her cancer. 

My mother was diagnosed with cancer in 1962, she put a lot 
of hope and faith in her doctors and General Hospital who were treating 
her. She often talked to me and other family members about her 

treatment, but at no time did she mention being apart of any experiments 
for the government. She would have talked to me and other family members 
before ever consenting to any experiments. 

I am appalled to think that Dr. Eugene Saenger, his associates and 
our Federal Government would join is such an inhumane act. I also 
believe Dr. Eugene Saenger violated his moral and ethical obligation 
toward his patients. 

We were taught as children and young adult, to believe in our 
Federal Government, that they would make all the right decisions 
concerning our welfare as people. For the government to sponsor a 
radiation experiment of this nature, on my mother and other patients 
was totally immoial. 



Herbert F. Varin (Son) 



314 



iOi Chalrp«r«on of tha Congr«s*lon«l Comaltts* 

SlSt Ths Partial and Wbola Body Radiation 
Bxparlaant Conducted from 1960-1971 

tUGUt Mr. Woody Flair and Family o£ Mra . Beatrice Plair 

This letter was very difficult to write for us, the family 
i 
(if our departed wife, mother and grandmother. We conversed of 

many traumatic thoughts and feelings regarding our loss. 

Herein is the summation of our collective thoughts and 

feelings. Dr. Saenger states that the patients and families gave 

their consent to receive partial or whole body radiation. For 

the record, our mother loved life and she would have never given 

her consent to any treatment that would have shortened her life 

I 

or cause her the pain, we observed. She never knew she was part 
of the Cold War Radiation Experiment. As a family, we were never 
tiold of her participation in partial or whole radiation. We 
would have not given our consent for her participation in an 
experiment. At no point in the supposed treatments of our mother 
(iid anyone tell our father nor her children that she was part of 

a dangerous and life threatening experiment. 

i 

What we can say to the Sub-committee is that we remember our 

mother complaining of increased pain, especially following the 

jj'adiation exposures. We can told you how our mother told us she 

felt as though she was on "fire" or "burning all over". We can 

tiell this committee, we resent our mother being used as a human 

(Suinea Pig and the implication by Dr. Saenger that our mother 

agreed to have her body exposed to radiation injury that would 

lead to serious pain and shortening of her life. 



315 



The Plair family asked this Sub-committee to help us to 
bring the people who we feel shortened our mother's life to 
justice. 

' In a society where life, especially human life appears to be 
worth less and less, we and other families are depending on this 
$ub-committee to send a clear message to Dr. Saenger and 
associates, the University of Cincinnati Medical Center and the 
Oefense Department that human life is still important. 

We must let the world know that here in America, what makes 
us different and greater than other countries is that we truly 
value each and every human being regardless of their I.Q., 
education, race, creed, color or position in our society. If we 
Allow this travesty of justice to go unchallenged others may be 
unknowingly experimented upon in the future. 

Respectfully submitted, 

Mr. Woody Plair and Family 



316 



^e 8ea«on« Who Will Listen t 

i 

; X was 30 yeare old when my mother was stricken with cancer. 

She had six other children, three very young at home, the oldest 

Was 12. She was born (my mother) in Whitesburg, KY, 1916, only 

vient to the Second Grade of Grade School , was married at 13 years 

of age. When cancer struck she had no money. Her husband had 

only been dead a short time and she was struggling to care for 

her three girls at home. She wanted to spend as much time as she 

had left enjoying her three daughters. She was being treated as 

ap. out-patient at General Hospital. One day near the end nurse 

cjalled told her to come to hospital clinic. She took a taxi 

Because no one was available to drive her. She came home weak 

clnd vomiting. She was admitted to hospital and only lasted less 

than a month. When we (the family) found out recently about the 

I 

liSO Rad she had received my older sister felt she was to blame 
hlecause she did not go with her in taxi to clinic. She had to be 
noapitalized herself and may need constant care. A younger 
sister has M.S. and has not been told for fear she won't be able 
tio cope with it. I'm sure all the other families that are still 
ajlive are having similar problems. My prayers are with them too. 
AS you can tell from my letter, I don't have a good education. 
Should I be afraid to be treated in a hospital? Afraid of being 
u'sed for testing some other chemical to benefit our government. 
Or carry a Donor's Card bo if they wanted an organ they could 
take it at will? Something needs to be done it is up to you. 
Ij'm helpless. 

I Thank you. 

i 

I Bob Phillips 

' Son of Maud Jacobs #45 



317 

dfOSS Lillio Wright 
Chart No, 44174 



My mother Lillle Wright was admitted to Cincinnati 
General Hospital Aug 23, 1965. She was sent there for a 
biospy. She was yonfined to the hospital for one 1 week. 

The summary I recieved of her illness revealed that 
her biospy was performed. Aug 30, 1965 diagnosis was 
(tarcinoma of the breast. On September she was given partial 
body irrodation 200 rad midline. On October 8, 1965 local 
x-ray therapy began. In 53 days she( Lillie Wright) had 
recieved 2000 rads to her left and right chest. 

I On December 1, 1965 x-ray was begun on the 

I 

imtermammary chain and to the anterior and posterior above 

the collarbone region (supraclavicular). She received 4000 

in 40 days. Her white blood cell count fell to a low of 

i 

2200 on December 3, 1965. These doses of radiation in 

my opinion was enough to destroy bone marrow and white 

i 

blood cells and even the patient. 

I 
I 

I We the family of Lillie Wright was not notified about 
these radiation treatments or any other procedures which 
piay have taken place. We did not sign any papers to permit 
this experiment to be done on her( Lillie Wright). 



^T3 --75-/- SXC] 
T^i7 l^0M.^,,j^ PL 



318 



The doctor at the hospital gave her sample tubes o£ 

I 
pnlment to use on her breasts, her back and abdomen. 

lier skin was burned on both breast. Her back and abdomen, 

"There was raw flesh exposed where once there were skin. 

I had to apply this oniment to those exposed areas -When 

1 applied this oniment to those raw areas she was in such 

©xcruciatincf pain 1 cried. She was given enough oniment 

i 

for 1 week. She was given Morphine which last 1or 2 weeks. 

1 do not recall the name on the oniment tubes (3) but both 

of these product was given to her around December of 1965. 

I 

Neither of these medication helped her. When a person 

is real ill I was under the impression someone have to 

Sign for medication such as morphine for a patient which 

is terminally ill. She was kept in the dark about the 

treatments she was receiving. She never talked about it. 

It's not fair to treat another human being as a guinea 

pig because they are poor and uneducated. Some of our 

parents didn't have the privileges we are blessed with 

I 

today. 



319 



I took my mother back to the hospital Feb 12, 1965 
around 10x30 or 11:00, My nephew and I stayed at the 
hospital until 3:00 am I asked the receptionist if they 
were re-admitting her and she said yes we should go home 
and get some rest. when I return home my husband called 
me from his job and told me my mother had died. The people 
at the hospital never did call me to irtform me .of her death. 

I'm her daughter, I should have been informed about 
her death before I left the hospital, I was at the hospital 
at 3:00 am the death certificate states she died at this 
time. Feb 13, 1966. I thought the nearest relative was 

to be informed first. 

I 



320 

How I feel about ray mother participating in the experiment , 

I 

I'm very angry about this doctor taking it upon himself 
to use poor live, uneducated human beings for his personal 

fame and gain. These human beings had the right to 

I 

live the rest of their lives until God was ready for them 

to die. Not to die because man want to find out what effect 

it would have on soldiers in the war zone. 

My family have been deprived of what days my mother 
i 
could have lived. I know she wasn't educated but she knew 

Something was wrong but she didn't know what it was. 

I don't like it because she Lillie Wright was kept 

in the dark about this experiment. It's a disgrace to 

use high doses of radiation on anyone why didn't you 

experiment on your love one? No because they are special 

^o you. Remember someday you will reap your just reward. 



321 



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322 



Date'! April 4, 1994 

To: Robert B. Newman, Attorney at Law 

Proms Members of the Maude Jacobs Family 

Subject: Radiation Testing at DC (Cincinnati General Hospital) 

i 

This' correspondence is regarding Maude Jacobs, a £emale Caucasian, 
who was an unsuspecting victim of the radiation tests conducted by 
the University of Cincinnati. Maude was born in Whitesburg, 
Kentucky on June 7, 1916. The third grade was her final year of 
formal education. By the time she was thirteen years old, she was 
married and had given birth to her first child. She bore seven 
children in all, six girls and one son. She was a beautiful woman 
with a lovely radiant smile. She was impeccable about her 
children's appearance, as well as her own. Her devotion to her 
family was obvious to anyone who knew her. Maude lived her life 
below the poverty level, but was a proud and dignified woman. She 
was genuinely happy with the simple things in life. Her delight 
was Cooking and caring for her children, when she died she was a 
widoir and left three minor children at home. 

According to information from CGH (Cincinnati General Hospital}, 
Maude was diagnosed with breast cancer on July 17, 1964, A 
treatment of hexamethy 1 me 1 amine began on July 27,1964 and was 
completed on August 18, 1964. With this medication her primary 
tumor receded markedly. On November 7, 1964 total body irradiation 
was administered. The midline absorbed tissue dose was 150 rad (250 
r midline air dose). At the termination of the treatment she had 
sevekre vomiting for twenty-four hours, in spite of intramuscular 
compazine. Before treatment she had a normal hemogram. Seven days 
aftet treatment the white blood count began to fall. The platelet 
count fell around fourteen days after treatment. The WBC was 1,000 
and platelet count was 80,000 twenty-three days after treatment. On 
the twenty-fourth day, the WBC was 850 and platelet count was 
38,000. Maude died December 2, 1964. Twent_yzJLLy.e_daxa__after_total 
bodjL- ir radiation. She was study number 045 . (Documentatioh from CGH 
attached. ) 

Two letters written by Maude to her sister Arlie less than two 
months before her death describes how she felt, and also indicates 
she thought the doctors did not know what was wrong with her. She 
talks of living near her oldest daughter, Lillian, who is very 
helpful to Maude. She also is pleased to be home with her children, 
but feels sorry because she is too tired in the evenings after 
preparing dinner to watch television with them. She refers to the 

expehse of her medication and said prayer helps her more than the 
Hnrjt.firR . Thp^ift 1«1-1-prs Hpmnnst rat «» h^r AiinraVirtn 1 »v*1 Knf alcjo 



323 



doctors. These letters demonstrate her education level, but also 
reve«l her devotion to her children. Maude had no knowledge of the 
seriousness of her cancer much less knowledge of the radiation 



324 



tr«a;tmant. She did not expect to di«. If she had, ahe would have 
disduseed the future care of her minor daughters with the rest of 
the family. Her death was 30 sudden and unexpected the family was 
totally unprepared. The three young daughters eventually were put 
in 6t. Aloyiius Orphanage. (The two letters from Maude to her 
sist;er are attached.) 

Thejfamily was NEVER informed of the radiation test or it's 
purpose. Nor was anyone ever asked to sign a consent form or give 
verhjal permission for testing. Some of the memories which were 
disn^issed without attaching importance now make sense or at least 
rais« suspicion. Her daughter Irene was seven months pregnant at 
the time and was having a difficult pregnancy. She remembers 
Maudie's bright smile and cheerfulness, then remembers a private 
room' and no more smiles or happy faces. Irene remembers being 
afraid of going into that room. Maude asked her to feel her head 
and when she did it felt full of soft tumors. Her body felt like 
sand. Even in the hallway she could hear Maude's delirious talk. 

I 
Maudie's daughter Sherry was twelve years old and remembers the 
private room, but at the time didn't know it was uncommon for a 
person without insurance. Sherry remembers the orphanage and being 
spli[t up from her two younger sisters. The youngest girl, Kim, 
eventually went to a foster family. 



Robert Murphy, one of Maude's grandson's, remembers thinking how 
nice it was to have a private room without insurance. Bill Murphy, 
another grandson recalls visiting her in the private room, but not 
wondjering why she was there. He remembers her conversation as "out 
of her head". 

Her oldest daughter, Lillian Murphy Pagano, lived downstairs from 
Maude and was her pirimary care provider. Lillian was never 
cont'acted or consulted about her mother's treatment. She remembers 
a dr4stic mood change associated with rapid physical deterioration. 
She too recalls the private room at the end. She remembers thinking 
her body felt like sand. She was concerned too for Irene, because 
of her pregnancy and the worsening of their mother's health so 
rapidly. Lillian's concern grew as Maude quickly became disoriented 
and ko longer recognized anyone. She was violently ill and talking 
utter nonsense, Maude died before her time everyone felt. Her 
family lived for the next twenty-nine plus years with the sadness 
of hier death, but also had warm memories to console them. 

Since the details of the experiments became public, the entire 
family has been drastically affected. Now guilt has replaced the 
sadnisBS and comments like "I should have known" or "I should have 
askejd" are commonplace. Reliving Maude's last days over and over, 
remetnbering differently now why she was so violently ill, how she 
suffjered, and now a reason for the private room. Her death is now 
a nightmare. She died without comfort and dignity. She was 



325 



R*r children want an apology. Th«y want to know nothing th«y could 
hav* don* would have altered the results. They want Maude to know 
they are sorry if they disappointed her because she suffered 
needleBsly without intervention from them. They also need a quick 
resolution so this too can be a memory. Already too much damage has 
beeni realized. 

Lillian Murphy Pagano (Maude's oldest daughter) feels personally 
responsible for her death. She became obsessed with Maude's death, 
often calling other family members several times a day to go over 
some part of her last days again and again. She was found several 
times at three or four o'clock in the morning with a fixed stare 
and silent sobs. Eventually she was rushed to the hospital with a 
suspected heart attack. After a short stay of a few days, some 
testing, several prescriptions, and instructions to avoid stressful 
situations, she was permitted to go home. Anxiety struck again 
within a few weeks. This time she was gone. Lillian's daughter 
found her, called 911, and received over the phone guidance for 
delivering CPR. When paramedics arrived, she was given multiple 
shoc'k treatments to revive her. It is estimated she was dead for 
four minutes. She was on a respirator and in a coma; she also had 
several seizures. The doctor's gave her a 50% chance of pulling 
through, but warned all about the possibility of permanent brain 
dama'ge. She has regained consciousness, but is still in critical 
condition at this writing. She recognizes family members, but is 
mentally unstable. The extent of damage is still unknown. Her 
family has been told she will need twenty- four care and cannot be 
e^cposed to ANT stressful situations. She doesn't talk about Maude 
now. She doesn't even remember who visited her an hour ago. 

The Ordeal with the UC experiments must come to a swift conclusion. 
This is the saga of only one family, there is supposed to be 
eighty-seven more victims with families. It's amazing how something 
that was a remote, barely thought of memory, now is resurrected and 
grown into an unwelcome demanding problem. A problem that can 
consume your days and affect people from twenty-nine years of 
family growth people Maude never could have known. 

This letter was compiled from the hearts and thoughts of Maude 

Jacob's children: 

Lillian Murphy Pagano (nee Phillips) 

Irene Froman (nee Phillips) 

Bob Phillips 

Betty Wolfe (nee Phillips) 

Sheriry Brabant (nee Jacobs) 

Janet Baker (nee Jacobs) 

Kim jSwedo ( nee Jacobs) 



Atta'chments 



326 



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DEPARTMENT OF THE »flkv 

OFFICE OF THE SUaiEON -;£Ncn*L 

RESEARCH AND OEVE.O^MENT CIVISION 

AASHINCTON 2!. 0. C 

APPLICATION FOR RESEARCH CONTRACT • PART 1 



form Aoproied 

Budget flurcon An ■;•-■/<;;« 



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DtPARTMCNT OT THt »IIMT 

OFFICE OF THC SURGEON GENERAL 

RIStARCH AND DEVELOPMENT DIVISION 

WASHINGTON 2S. 0. C 

APPLICATION FOR RESEARCH CONTRACT - PART II 



Form Approved 

Budtrl Burrav Vo. 49.R3U 



TITU OF FMJICT 



Metabolic chaa^ei in Hu.-nass tdUowing Total Body Bariiatlon 



FUNDS REQUESTED (On* <rrar only) 



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332 



OEP»RTMENT OF THE »SMT 

OFFICE OF THE SUROEON GENERAL 

RESEARCH AND DEVELOPMENT DIVISION 

WASHINGTON 25 0. C. 

APPLICATION FOR RESEARCH CONTRACT - PART III 



Form Appr«T»d 

Badqmt Burtau No. 49 RJ44 



T.Tic o> MOJECT ^^^^j^ue Chan^cs in Hnanann FoUavHiK; Total Body Ratliatioa 



RESEARCH PLAN 

3. Sdcntiils baek-TTOoad. ^ 



Several reports have described changes in nitrogen tnetaboUszi following 
irradiation (1,2,3). /Jl have chovTa incrcaso ia ziitro;;cn c:£erctioa foUov.-in'; total 
body irraLiatioa to various laboratory aai.r.ata. Mciiord and Martens (•!) bave 
studied a.-ni30-aciduria by paper ciiro:nato:^aphy ia rats. ;:ats a=.u ilastcrlil: (5), 
and IIo.T>pcI..innn, licco and Xio^=r.aa (6) have studied a.7uao>aciuirla foUo\/is^ 
radiatiea in b.a.:iani> by nicano oi paper chro.-nato^ra^y. ilciivipcl^iana, ct al, 
found a.nino-aciduria in 3 oi their 9 cases. 

ICats and llastcrlil; reported increases oi as hirh as ten ti.'ACS nor.-nal values 
of tctal ucoly a.-.iino acid csicrcUon in <1- patients. Coantitiea oi iuuiviuaal a-dno 
acids ccicrot^d varied iror.i Z ' iH ti.Aeo norsval values. Abnor-nal values v.vre 
found as early as 12 hours following cripocure, and Increased levels persisted fur 
as lon3 ac 5 uaonths. lio direct quantitative relation to radiation coco could be 
establiclieu. 

These finuin-rs su^^'^cst that a.-'uno-aciduria may serve as an i:idi:atcr ot tlie 
bioiojieal ros-vonso of au..ians tj irra-iiation. The reports cX a.-.\ii>o-aciU-^7ia in 
hu..';an3 .1S.VJ <.'-iSc;ibud the finiLin^s in individuals ccrvssedin reactor aecitlents 
(3, C) ZL2.'l ;^e control r.ieaoure -.icnts \.'crc possible., fuc ijronoscij. investi -clian 
-«.iil inci.._j studies oi a—iino-acid ciicrctian before and after irrauiatian boui to 
the v.'hele i.-oCy and to portions of the body. The urinary crxrctiou of a..'.ino aci:.s 
v.iii be ^i::e.sured both by paper chro»';nto';;raphy and total a. iiii.> acid nitrogen i:. 
order to li^u a relatively CiirAplc teciL.uc'je for biolo-;icai of.jcts of i7rac-ie.uc;n. 
3i'3nificant increases in total ar.uno acids and indi\-iciual a:.-.ino acids will he ssu-i.c. 
The a.uiua acid levels v^ill bo co.Apared to levels oi creatine (10) a^u urea (11). 

These studies will bo valuable in tho undcrstandin;; oi the z^cclianisi^c of 
aminn-aciJnria. Prsli::iinary ctudiss by our ^oup have dcsionsti-ated that trziicizr. 
anino-aci;lurin v.ill also occur with e:3encivc surgical procedures and -.vith in.ecti.-: 
^ Studies of D pati-nto cnpoccd at tlie Y-12 acUdent at Oah .dd:;o in June I'JSJ sliov/ed 
elevated cncvction oi beta nrr.inniso butyric acid v/ith levels related to the tctal dj&e 
received by the individual. 

4. Scientific Seopo of the Propoaed P.eocarch. 

/k^iino- aciduria ioUowin-; irradiation has boon reported in hu.nans and 
ani.-nals. The purposes oi this investigation is to study this phcno..ieuon to 

(3) 



^''"/^^l"" 108s '««viou» coition* or tmi» form mav ■■ umco 



333 



nON IS COMVLCTIO nCMOVC i.AftT CO^r worn VOUM riucs. 
cahson »a#i» and «cm.«cc ^itoTccTon smcct 

iNAL AND MA«TCR CO^V TO OFriCC OF THt SURGION OCNCWAL- 



OtMRTMENT OF THE AilHr 

OFFICE OF THE SURGEON GENERAL 

RESEARCH AND DEVELOPMENT DIVISION 

WASHINGTON 2S. D. C. 

APPLICATION FOR RESEARCH CONTRACT - PART 



lad««< fofvon No. 41H)44 



TITLE or FtOJCCT 



Ictabaiic Cliaarjes ia Muaaano roUowinj Total IJody Radiation 



RESEARCH PLAN 
« la Jilill. M«»mc»»» at lAU m i M iA. D« «»ldl«««al *««u. tf MMaorrJ 

ciucicato come o£ tUc --uichanio.-.\a reoponaihlc for a:niBO»aciuari3 a»d to (lctsr..u.ic 
v.'hcthcr it i3 a practical biaic^sal tcct o£ raciatioii czpocuro. 

7bc Dccitn of thj ■'roToajc; r.oc-;arch is r.a ioUov/3; 

1. Co.r.paricca oi tecj:uquss la? dstir.ruaatioa oi.' urinary « i<n.t acids by 
t!ii "."aa wiy:-.3 aad cliro^afJ^raixiic tcchsiqucs. 

2. C:tjr.:un3.iis3 c£ c:ccrcLl:;ii c£ oriaary amino zcido tt various doo&~es of 
tovol ucuy IrrsciAtion. 

3. A c&iUy oi tUo electa of partial versus total body iiratliatioa oa uriaary 
a. .iuu acid ciccrcUsa. 

4. £tuii;3 of tlia i.-ir-mne mcstaais.-.is of hoaaao recci.inj total body irraciiLlo.- 

S-ljc'-ic:-. .-; ~-a.ti::it3 



. ji- 



Pati;r.t5 ill- tatil b;iy irraO-atioa v.-ill bo li..iitjd to r.dilt .r^ilss vrho have 
pravcix ...cii::iitis ..i:i7.i=;vjy bat r^j ia --od a-tritioinl L":itc. ."li-: cmacs \,ili 
bj U-u'._-U to ..-.::-:oj js;cavicc oi U;c \r«.riiti:^33 ia a .-.iao-csiil-iria isirivl v.iLa t.is 
r.-.castr^J. cyci: i.i •..-a.v.ca. t:i;.co ^i:;tii=:s v.iil ao us:'i ijv ^-r rt= i ar.d ;:. L^ r.r:r 
3 ..>alj -.= i^.ts \.;ii arc rec'jiviij-: v-.i-ti-,-i thcranyicr c-s -.Ir-j.-is v.iil also b2 
i^clu-cil. _:.:oj;-i ir. s.^jcial cicoj v.3 -jtcci bc*ow, -ati-.riia -..i.Ii iy .i-.'ja.-.as v,?... 
ist o- ^iS-u Li f.ijc; s:_Jlcc. ..11 7:.d=ut3 v.iil iio liccnitalisod .-.t tlii Ciaci-.r.-.ti 
Gcacral :;» j::i;-i. rUsy v.iU Liivj ::i=toric=, r.Uycicii c:n i.iaatio::.3, routiuc h 
tolojicai a:isl urias ctsicioe aaci c:ii:r la';:c:.-ato7y ctauicc ac tcoCsd. 

Factors for irraciatisn arc as foUovra: 

V,cstiii.:;hottoo Ccatirocoadcx coastaat notsatial thcroTy unit 250 IX, 15 Ma, fi:u-;:^.:-. 
2. Oi.i.-T Ca V i x-i_^ /U. , il.y.i.. 2.0 .n -A Ou. l".^ 2l\i cva. Alco U>tal body 
irrauiatiia v.iU La carried oat vitli C-ibait CO telefaorany. :.:2a3u?e.;i.iiit3 -^-ill Lc 
cUccUcd by tlia Vlctcrcsn cc;.cic.iccr r-witcr aad caliai-atcc ZicauL-: doai.nat^rn 
usiiij ii^coaits aad v.-atcr ?!'jato_»8. TUa tocfaaiquo of irraciroion v/iU to ci-.iiior 
to l.iat of ;..iaclair t: Cclc (12). 

Uriao rt:t:'iso 

r--ti. "■ " ricon of r.mcr Cliro .ata rra-,hy an d Totil *. ..ij;r> n.-iC :;i:^ro-rrr. 

T..O r—u-.c of i a.:alt .t-^Isc -..iU rotcivc jD r c: fjta: b- y rr :.:.- ji j;i i:i a /..: l ; 
dois. v.:icu-> A \.iii cij:.ist ci •:i;i:;:.c -..iia rc:.ativ^iy ra.-:i-.-,;,i.-.,^.. .^..ii.-. . -. :. 



OTSG FORM inRK M«»vio«iiSiTiON 



334 



COMPLCTKD MEMOVC I^ST CO^V POM TOUN riLCS. 
•t PA^CM AND l»Km.*rc PMOTECTOM ShccT 

o MASTtii corr to orrici of tmi suhoion oinchal. 



Cmm 



DEPARTMENT OF THE ARMT 

OFFICE OF THE SURGEON GENERAL 

RESEARCH AND DEVELOPMENT DIVISION 

WASHINCTON 25. D. C 

APPLICATION FOR RESEARCH CONTRACT • PART III 

TITLI or PPOJf CT 



...ctauolic Clutacos ia I-Ia;jaans iToUavoog Total Zo^ SAtiiution 



RESEARCH PLAN 



(i«ii»«i mi II I 111 I 



•tosiaeh, bovol. brain) and Croup a o£ patients xAth highly nuUo-aonsitivo turr^ro 
(lympiiouiaa). 



Prior to irradiation uriaas v;lil oz coUccted tor several days to aorve as 
coatrulo. .'.li oriaas v,lll bo coiicctcd tar 24 hoar periods, /ji aiioaot iror.i the 
ccrly - :onii33 iactia-j sa^inic v.ill bs Twiri '-crate;: and tlia 
the Z'.- hsur uiiie bjlow. The vci.ia 
and irosea for tuc 2-i-bour T::;riowj. 
b=th teclijiqusa ior iactiai cad pooled voi; 



pro-.-idoa caou^i data, the test can ua «' ' M Ti-'d. 



c;.iaiaC::r pooled v.ith 
3 v.-iii then b2 ceiljctcd, rc-:I-'oratcd, pooled 
■Jl Ci.r.ple» T.-ill be aaalyscu ia trl jUcate Uy 
I£ the >niti?l i^ciia-; cpeci.'.i.ea 



7ct-a urinary a::iiao acids irili l>a dctcr-.Tined by the moUiod of Vaa Cl/iie, 
-•.Iac:rr.:.-s.ea aisi. Il^i.-.altaa <7). r..a <:i:^.i;a3ioa3l ra-ar pciadoa ckro-jita-ratjiiy 
uiU bi Cirricd cut accoraiaj to tlij ..i>Uii;:l3 of i-ioc:;, -ur ?:.-.-. aau -v.ti jVj)'. 

The ;;: liour iiriaca 'iill be asii^-sjufor oric r.cid, tire-i crcatlae, crcitiaiiie 
cau tatsi iiUi-ojoa. /ui ajte;.ipt v-i^i ba i.iace to K«uataia tiJ riti ■-♦n ia af-pros:- 
i~..at<:;i/ tij ca..-io citi'o^cn cquiiibi'iai.i, 

i:ij \-al.;=a o:^talaed by tia two -acthida v.iU bo coi-zjarovl by aaalyaio of 
\-ariaaco nad uy «-oter.;-iiaati3a Oa" re— cssica coeiiiciaris u- t^u %-=,iiiw;3 o*' ilio Vna 
wiyl-.e .-.".c'.oad v^r=ao these oi cUro /•^t^-rraijlij-. la ^..^^^.i co..-.r»ricoa of a..-.i_io 
wCid o.icrcaon ia ratieato v.iUi Iwio.va t.w-:.i"icti=a of iar; ; i.icso-o cf tu. lor 
(Croij-? .C) caa be co;.ip3rcd to tasse ia v.ljj^ cucii a pa5a3:^.caoa is uilL-.jly ( Jru.-.i. 

r>ert 2. Deter iqiation o: ::::cr>.ticn cf Urinary Ainiaa /.ei-jo r.t Varicas I^os^-:.:: 



fatiiats to be sfociad viil iaclada tboac iaui\-idaals wita raetactatic acopLic. -.a 
aad alco r^aticats vao oro rec;ivia:T va;:Liiioa tiicrapy ia ca a:tc:;'.pt to cure or 
pclllate \-arious aear^sj-io. r-aaeala ia taia study vrill aot l-Jive Lad pre-Aaus 
irraiiatiea so as tj avoid carry-o/cr ail-cta. In tae iaiiaal ceiectija of naticats 
iLo jrou.i ai paarats wiUi i.^ctabiiroUc aeooiaoms cannot to cei-;ctcdat raaden 
f.-o.a a iiirE..ai vcpaiutiua ior iuei-icica ia tae study since aornial iauividuaia m.-.-. f 
bo J7lvca twtal -oay rauiatiaa. 

Cclcctioa criteria arc za lellov.-c: 

A. r-r..I_nt te luive pre.-ca ii-.-.ijjio cf ner>pi£j..\. 

Z, : ;.U,-:.t ij a;;v.- i-z-^v;:^ L:.i..^.icc ci riCaoir-'JU, 
3. ".■'.tijrt to ;>: s:i c-iJ,:ir'.=;i-.-j- aj;tri;i.\-:al atnu. 



335 



r tLn. 



DEPARTMENT OF THE ARMY 

OFFICE OF THE SURGEON GENERAL 

RESEARCH AN3 DEVELOPMENT CIVISION 

WASHIN3T0N 25. 0. C 



Form Appnr94 

Badm lunau No. 49 R}44 



APPLICATION FOR RESEARCH CONTRACT - PART III 



Tint OF PHOilCT 



-taUsUc Chan^^co ia Ka:r.ans r'oiLsvnnj Votal I>o(ly Ivakdation 



RESEARCH PLAN 



The paticios v.ill ud 8clcct.2(l £or thrao aubrproupa of total ludy irr&dlatloa by 
rands .-7d:u.uuii. wab;;;ro'ap A v.-iil serve an controls rjsjl will Iiavc ail -_:rocodJX2s 
cajrricci out c:icc*jt uiat tuuy will receive o^ia.;! iri-auiation only. wL^ I-outi ^ '..iU 
receive Z3 r szid Tu j^roup C v.-ill receive OQ r. }^ach ^^=^7 v.-iU coii£:iBt oi 4 
patients. XIic .r.eau vsluoa oi tTtal a.'.Tino acids in the uririi oi ths tLrce rr-iups 
\.ill be t2c;ttd ior ci pii^cant uL.'»jr;;:ict;c by anrlyeio ai vai-i-ncc. ^ubjroap A v.iii 
be t.'jtju ::--aaet .^uu-jraupa Z z^:C Z. ..Iza J-abjrcup .0 Aiil i>:i tcotud a3aijst :.uj- 
^roup O. .'urtlur ^roupc will be cuidicd at ICO r and 200 r. 

I£ t!i.:^rc ie no ci;;;iiilcaiit clltsrcnca 'ix;f.-.-can 3 aau C. then aduiticnal nitb;jro7.-7: 
will be ctjoioil ai oirjojircs o." j.i.l- a:id i J r c^ touil b«iV/ irra-iiitioa. Cnn ol 
the pacci-ic rcr.cons tliat a r-iir.tL^a L--;t\.-j-'a raciauon c:i:joijtirs and a..\iu3 aci- 
eiMJrctioa ..^y r_a=ii a i-iatt-.-va \-iU= b.is./ JiS r oi total bu;;y ii-ra;^ati'j:i. It is :-r 
tills r=:i3ja tliat ta::so a-JiUonal ^jroa: z ..\ay poc-jira 6tucy. . z^Jtiiots \.iU, bo 
placed i;i UiiCj cjvcrai ^ro^ipa by t.:_ sa ..o tccuJ-r^ua Oi r;i-Ai>..ii:;atian as t—eci-i.i_ 
abov:.. .nsCior ^:.oup oi s.ia..i irra-iat«jd coutrcic v.ill ba pvo.'id;.din orc~:r Kit to 
lose Lid..;o.:.iw-;iac oi co .icari:;cns* 

-Vt tbs catici-jsion of tticsc ctu'.loa £iirU.jr analysis o: the da'^ v.ill bo carriic 
out wita cals-.i:;\;ij.i» based on tk- iiCv- ;ral dose rccti/ca by cica j^ti^ut. I'hs 
do£a;;;c r_c:5oa5e r jlationohixi "'**i si'.oa bw; d.jtcr..d^cu. 

T.-.rt 3. "f.-.i.'/ =: til J :'r:.:;cts o£ r -.•.•tial vory-is Tcf.l :-.ody rr;-;.ci-\aon »:-. ";-i:v-. ly 



<\itcr cuitablo base line valu-c arc cstabliched as d^ssri-id t'art Z, mti/j.,!- 
studies will lo carried out in Oi-d-r to c<»..»pare total bevy Lrrr.di-jtijn v.itli tij-;; 
u£ localized iriaiiatioa to .-jive cn-.iai iatc jrd doir.3e. - or c.-ia ■•.:-'iJ, il a p:iUc;ne 
receives tatai bjdy irrataatioa v.i'di an L;tc3ral doce of f j,00 J :n'a .\ rount ;:;;s, 
his a.iu:ic>«aciuii;.-ia \.iil be co.-.:pared \ ita tl:at oi an iadi'/idud \..ho has r;ctiv..d 
an e^-ial ir.tejral dose v/iiu all irra-iatioi; >ii/on to a lociiiaed re ;ioa ai tlii c.-*c'/. 
Oac r^reun ci piitisata v.ill rcc-i/e t.;e dooj ta tie ur-_>jr r.bda. -.cr., aaotUer fjrauy 
to the cl-js;, a.uji;;ier ^roup to t;i j h.a.d c^-.d r.ecl:. These T'cti juts \ ill hive de- 
ter..aiiatijao tu ii-inary a..-.iiio acids L-Jero rccciviu3 radiation aiad v.iil ua xolle .. 
^ter\.-arda isr a ;jeriod u£ one to wvr^j years. 

TjjC .^.-=t ,-jroui te bo st idi_d ..ii. be t.-.jcj pati.;.-ito \.l:c» r JCti/c ijcniii-d 
irradiatie:-. fj la. lidjijys aad iiv.-r. wii.c • liT.-.;i:iUii:i to f.li'. v m.' di .•: '-• o.- ;.-.-.:; 

{ :; 



336 



icv« last copv for vo>;r lilej. 
■place protecio; meet beio;« reiununa 



DEPARTMENT OF THE ARMY 

OrnCE OF THE SURGEON GENERAL 

RESEARCH AND CEVELOPMENT CIVISION 

WASHJNGTON 25. 0. C. 

APPLICATION FOR RESEARCH CONTRACT • PART III 



Form Appnwwd 

Bud9*t Bunmi No. 49Jt3'>4 



TiTL. Of '•»«".•. :i,t;ii5oUc Ciian^cs in Kumaaa rollo\Tin3 Total Soay Radiation 

RESEARCH PLAN 
-flocJarf* fc «j ifci | i««» d . gr m r i lt c aim». aslteda oi »i«c«du* ia dmtaiL ■igni hc ga c * o4 IhiM ntmatKb. Uw addllieaaj pavM. U atfcttnorr J 

may provida a mcchaalorn. for a:rJno»acicliiri3 (eco Part 1) it will be valuable ta 
dctcri.iia: tiu icvola oi a-..':iaa-aci-_Mria ioliovia^ tliis tyrio of irrac-iation. It :i;-^s* 
b2 recojrjssii tiiat in arirjiv-ii'.j raciatiaa to tlic hti..iaa it is not paaoi'-ilo to irra_i^to 
tiic liver -..iLJicut irraciatia;; tj-; ISiji^/a aiid coavcrsdy onj cannot irrauiats t'.iii 
ladacya v.i':.iovit ii-vii_iatia3 tii2 livor. 11 tha a.-iiao-ncid.iria is oi tlio car.ic oi-cor 
o; .:-,a;jaivU.i.j as t>.at fauna v.itli tctal boiiy irra>~ia£ia:i, it v.iil ou '.'iSt t.iat irrid- 
iatioa oi citli-T or ixiUi ox t^u or.;:i-is is I'cc^sasiblc for tli^s:; f i i..i:f;c. '.'Iio 
sccoaci jrouo to be ctuuicd arc tlus: iriCiviuoais rsc»i\-i.i-; ijcaii^::^ raciatisa ta 
th3 ci-.=s.. If tlis a:.iiiio-aci(lu.i'ia c^iproac.ica levels equal to tlij^e found ..ith totrj 
bod/ irrr.caa'aoa iu co..iparaolc iat.^rai cjsjb, iacruaccd tissue l;i-ca:;dov.-u chouiu 
be cusjj^ct.^d« 

fro.. I a practical vicwrxjint th.:oe tv.o -roups \.ill bj Mi'.iaid ci.r.ui'.anoauEl/ 
d jpc;i:li:'i 3 vv_voa ciiaicai r.^tcriai a'.Tjla>lc ba tis f u.aor iicr'.-icu oi t'^s ^Jiaci:L.^;ii 
C-ea:rai l.^sr.ital. 



Li csrr/'.i-atiaa •..•itb Dr. /..J. i.ui=io of tha r.adio'-iol'jj/ i, -Trart.r. or.t, 'J.~. 

*.r..v/ ical ..jst^avch j-aix:rat:;ry, _ t. il^-.o::, .1/, v.c c^-.jJ. cu;^:_>:/ bloo'-t cr.-.-.-. 

ca .ijics i.-j:.' ail ■-.aiijats irraUa;; — a: dwuc»ij2u nrov-ii.-riy. ..a... -.ics •.■.iii 1>J 
o'_;ai.;>.u -.^^i prior lo irrauiaciwii ;-:Ji i_--,r irrat-i^don a-u t.;a cays af^er iiiai- 
iaUau. ..l.ey \.ili li^i c^at to i-'r. J..uauio for liis stuoios. 



1. Bru^c, .V. t I.'uclca; ocicacc . .bstrciciS, 7:7. l';53. 

2. Cussafsoa.vj. 1— , and .'oljtc::/, _. , — i. J. '. aysiol. 171: ifj" (I'SZ). 

3. ..hitc;, J. , w'.ivr, Ji.-".. , and f ca,:i.-:r. f..r2oaay iCilio-iai l-ai>cratory Cuavu-ii/ 

r.:;2'^**» -'ob, .ar..''riril I'.IiZ, -iV/i, 

4. ^'.cIford, .... fj. , Itartwu:>, 1I.I.Z. > .'vCi-incc, 122:327, (I'^SS). 

5. ICata, _..J. aal I-asterlil:, f-w. . J. ;;atioaal Janccv L:-Jt. ,1J::005 (1055). 

6. Ifan^il la-xi, i..i:, iisco,:-.. ar^d fljff-.iaii, J.C, ;.rji.Zat.. ltd. i6:277 (l.-l.). 

7. Vua -1",-'.:j,*j.1j. , . ac.'aydca,-'..'.. and llacailioa. P.-.. J. fl-ial. Ciis.n. 

li>u: 2.1. (f j'lli). 

V. i.locl-.,...J. ,_Mi-ia..*,...i.. liid .--.iij, J. , 4i ...aaual wf . art'.'r CA'.v^..:a.tOj,TC..'../ 
ar.-?. a-icr -.,ii:si-a-?.i5roi.is, .iCi -.ic r'rtss, lac.', fl^v. 7ori; i;ia. 



337 



remov« toji C3?y lor v-"^ filej, 
id r«plae« prouctor it)Mm o«ior« rttunuao 



OEMRTMENT OF THE ARMY 

OFFICE OF THE Sl/RGEON GENERAL 

RESEARCH ANO DEVELOPMENT DIVISION 

WASHINGTON 25. 0. C 



Fotm App n 9m4 

lud«M luraon Ho. 4>.lt}44 



APPLICATION FOR RESEARCH CONTRACT - PART III 



TiTLf or mojccr , . , ,, _, . 

-.ctaboiie Chonsea in i:a:.nans roUovuinj Total ^ody Touiiatioii 



10. .iVniiaraoa, 13. R. EXfocta oi iiadiatioa on Creatine ..iotaiaolis^. r^cUatton 

r.o3carch 7:JoO (1557) 

11. Kay, .^.-. , ::ariy, J. C. and r^n t e nm m, C. Hadiation Hus'jarch 6:9i3-109 

(1.57) 

12. CiaclAir, '..'.11, oud Cole, A. , Tschaiquo and CasL-.i-^try iav v'.iolc body x- 

IrraOatioa oi patlsats. cw.V.- iisport lio. 57- VU -^.ar. i;a7. 



SG fon» ,-„_ 



I. ». M>t«*.l*t •«<M'*. wf.tc . ••■i-.t«t3; 



338 



DEPARTMENT OF THE ARMY 

OFnCE OF THE SURGEON GENERAL 

RESEARCH AND DEVELOPMENT DIVISION 

WASHINGTON 2S. D. C. 

APPLICATION FOR RESEARCH CONTRACT - PART IV 



Form Approwmd 

(udval furaoB No. H-KUi 



fB J o giup hicoi tktttJt** rcqnijvd oo rffr*rflh/t lavvstlgotoT osd principal proimtaienal OMistoufs cnly* tl tbla is o r«qc«n lor r*B«fvci 
ooliiiag mutBUatlY t^* sen* pcraeaaai oa prmnouMlr. biovrapbieal Mkmtebma iriiJ oot b* aacacjorrJ 



I. NAMI 

Cugcno 1.. Sacn3cr, ;.I.C 



2. AOORCSS 



r;a;iioisotopc i^aooratory, Cincianntl 
General Ilocpitol, Cincinnati 29, Ohio 



4. lOUCATIONAL »AC«e«OUHD (CoU»»» oid/or l/nlnruirJ 

Harvard CoU.:;-;o A.S. , cun\ laudc SiocUcnical Sciences 1933 
University CLgrinnati, College o£ ..ItiuicinSa ^.1. 2. 1942 



f. RESEARCH TRAINING ti*^ o' iojlituljona. nnatth diractor. «ab/»cf oad doM«; 

t-.tcrr-e C^iarrU :ioc-;ital, CLiciuiiiiti i:v2-19'13 

.-.ccidcnt i:i -cuijljr^. Central IIoExatsl i;43-46 

CMjf :.;-.i_iiicot3v>c U;ut, ^roolic .\iT.-.y Iloo^ital, JTITIIT r;5'l-SiJ 

Cs:ioaita;-.t -iar_:ical .'.cGOirch i;.:it l.M-55 

I.i.-.cto::,.^i_ioisjt>:::c i-r-jorscsi"/, C.iiv. ox Cinti, Coll. oi . .^diciae 1750- 

Ac^ista;*! .'rcicscor o» .jioioio^jy i;'l'-57 

A:;dic. wii:ucii ''i-oicscar oi .Ir.diolo ;y ii57- 

wonsulcijit _rooI:c Amv/ ilsspiuU. l^^u- 



I. OTHER iNfORMATiON REARING ON ouALif iCATiONS (Hosp.iaJ oppomtmanu. praiaaiionoi lociaUaa. jpacioiir board, afcj 

.' Ucncir.j . zCijij -ist, winci:inr.:i: r.jrni Zl^c-.ltrJ; 

■ .r^CiL.ti-szi A"hjra:3i=t CiUiCrcu's i .3r-i:^l, Cine i; I'l.iti, CUo ; 

_i;.lo..iatc,.". -.oricr^i _t:r.ru o. ..-..Iijio ;y , ..Ic.uljur 

/;...cric.--i ..j_:it ;.:i ..ay . jcicty, ..ciiijij'jical Cocicty of ::-i-th ^i. ;i;rica, IlcalUi 

I'hysics ■ jci-tv; .' 1 ?ha O.'.i- 'i .1 Iia 



7. tiRLioCRARHT <Oo Bof iijf mora iboa taa puAUcaHonal 

1. i;ic;-x-j;r, .^. i,. ,>.t ai, l-.r.:r vacy . luacurca and prcca-otiona ia T^adiu;-;! acciL._;i;s. 

Jbur. ...jd. /..jsn. lly:;i;-v^ij Jun.j 2J, 1V52, 

2. Tvcsuits Oi" Thora-iy v4t;i .'.—dicictivo Ijdins-l^l i:i MypcrtijToidis.-n. Clua ttat^ . 

J-ur. i>C::2o-27, Jaii lit-i. — .i.. w..ja7cr, ct al. 

3. Sacii;'.or, _:.!.., ot al, i.ott';rci---i\.c'o l.i:^asc. i'rolda.no iii i^ia^nocis ar;d ■!■:•. ?v 

.-.-tcnt, .\i-iwr.Jour.i Jont, — r.d. ilijrany Cc I^acl .cd. i....^I, .,o, 3, ..^rc.i i .•; 
•1. Prot-.ctioa a- linct raci?.ticn3 irj . raijar.^, cotait-6-, and cc=iu.n-I37; I.iii.i..al 
wUi-w?.a o^ wtoiidardc .l:i:iii_oo;: 51, section », accii-ui-.ts cntr.iiias radJi.'do i 
lia-r.ids, ^2pt. i,5'l. ^.-.i^: ;or, —..;—, ct al. 

5. ra.-;:-;.r, .-.J... vt al, Jai-ci:i:j. xa uJ tlxi Proct.vtj; Tiici— ^ny v.ita T.adioactivc wolioi 

j^-id, w-.i. -.i-.-.i-.i- iorcjs -wvw J.cr. Vri:-!.*.'' (-'-:■•- ii A,:; l). 

6. j\ '....Lijd lor . .cini;uri.T; jr.c:: -i-3u;;«i iy ..-.cano o: :;i.-\ti-:ic:ii c.:..ii'ol ch..M-t. .!:; 

.. i". j»ar. -.ociit. ,..ai^ ilur:.-)/ •.': ..ac. u;.. _.....■ .1 ■: . i...'.C, Jr.." ..r, <. ,. .-.i, 

7. .'^.->.<. :■ r,.,.i., .:!: Jii, /> ■.iivt>jc. ..r i.:..-...ii: ; Llij 1d.:j i-j.-'r '.i. .. ..I-.i ;•.:.. .l....-.;i-,-.: 

i- -:''-'.J- ' -0-). -■5J1'. c. ..Ci..;j ..i^ ._ii.j...oij /•.,;_. ^,w.:. i,^C. 

u« --.■.-. ■.-^.« .-'..tii.rw;; ill t;ij j.rr.c.:^;^ ui i"",'.!"";. ry. _ i, . ._. _ .-i, ..I..1I.V',, 1.1 . 

- - t ni 






jo-.i-. 



e:^.i. 



SG FORM 

I ARR S4 108C 



^ • • kOvtAsal 



339 



DEPARTMENT OF THE ARMY «T '"'/""^ „ . ., 

OFRCE OF THE SUR5E0N GENERAL | 8ud».f auf.ou Wo. <» R:« 

RESEARCH AND DEVELOPMENT OUISION 
WASHINGTON 25. D. C 

APPLICATION FOR RESEARCH CONTRACT - PART IV 



BIOGRAPHY 



(BiOflTopiicol s^olehes n<tutn<l on r>ipoajil>.'* larinivotor and prmcipal pro)«iiiooa/ ouinantf ooJr. (/ Ihii u a r.auatt /or rte«v>o< 
auiUlaV tuanuailT tht taa» p«r<oao«/ ai pnrtouiJr. buvraphJcaJ l^orcJiaj iri/J no! Ix iu<:tuarrJ 



Guo6t, Coor-c ...artia, ....D. 



2. AOOflESS J ,jj 



4. COUCATIONAL lACKCAOUND (Coii«9« Ood/Or Uairttutr) 

Clda ..\.sl;/an University, Ivjiav.arj, Cliio K/IC-IS 
Univorsir/ oi Ciaci-iiia'-i, _..c. i:ij 

-^oiicj-: oi . .ccicias ..:.I3. Iv23 
..:.S. 1V23 



-'o-oaLatiaa. Ci.icii-.jiati Z?. Old.-a 



c 



5, RCSCARCH TRAiNms tUst at InsuzuUous, nMareb di/tctor. tu^lvct and doles/ " ' 

-i^uiau O ..;.:-al.:o=:i;ni. :-c^i...;.t i;> • -cxtli^iojy a:id t.str;xctor Tathol- -y i-.:-! ,. 
L-taUt ... .^y, ..ru= = .l;. ^a i^.... - -li5v/ o. the ^o.a.:u/:=i:,a xcr ..ciic. ii/;^ .i ia ' 

-Jost^u C;i:.:r^ra'a .Iji^iutal, I.;V-n i.i .-a^trics. ....ci^eat :ictorioio~i=t and ;..,.• - 

-aivcrriiy oi ^iacir::iau,^xicj^ o. .ua^iau, ..cnt. ox -^uiairico: Asa't Tiai. i;. :.." 
•1 „ ..i=ac 

i roi, oi .wvS.arca .'wtaat.-i 

• OTHI« iMrotMATiOA lIAtlNS 0\ OUAliriClTio-.i iHotp.ial appatnas*o». pra((uioaal wcl«Ua«. naelajly boaid. •leJ 

-=c. io»- --I'.iiic ...ij^ai-c;.( T-ii-.:;! i..:;:) .■:'""i^ "a"^~ * '" 

■••• -J'-* >>- -i-i*j jicai v-hs .-acts ■" 

-.iti-i.t. ^i;.,id:i-,. v^i t;:j .u.x. ..oarj oi Pscoatvics 1536 

7. •■•uofiMA^HY iOo aot Uat mon tham laa puAueauooMt 



*,■..#' 



*•• ^-"'^ '^ ^^' .:c...at-lj.^ic ..i.Uiiic ia Ct.cU.:-; :.at:iaonal scvcvaa. i:. . -i- 

Ucu; i.-.j u.v^r caajnoutic ..i.tlijas. l/th .-uui. coiu. , . i^.u-il; ..Iciorial • ^ ' ' 

■** ^'■■.V.■.^• f'" "-'.^t, '""■■;•*=. =-5-'--'^'^i"--i« pl-a8.>aoru8 CO .ipoauda oi tho Uoi^ 
. .1 ■'.■•'—>^» i>cv. — ;-.lu— .-.7, •■-A/ly-.i, 

-. 'wiacct,'.. . ., , ,.i al, ;.iau-ac cij .it: ."wUiJoli'' cl r.-i^i --> i >i<-«- «— • »_4..-j_i.- 

«aao,..-ia. .t-, .toc. . js. ....•7or...i.^;. :, ,-i^ a::^^-j^i, l,;,. 

^. ;-:i-i:. .. i.v..:l. =... a. ..J. . .. 7:.,.... i. :.. 

. ^---^. =. -.. -^rJ, .;aac.;. .: ^.,. c, ..rvlictorc o:^^,t..s, ..:..-^t.a J:J3.:, ;:-■ . 

'^ .:>.;.:- .i..... ;-._-.^.-^... ...c..-.^.:.. a^w.. Ji..-. ...i .1 ...: 

SG FORM 



340 



DEPARTMENT OF THE ARMY 

OrnCE OF THE SURGEON GENERAL 

RESEARCH AND DEVELOPMENT DIVISION 

WASHINGTON 2S. 0. C. 

APPLICATION FOR RESEARCH CONTRACT - PART IV 



Form Approvtd 

0ad««t Buraou Ho. 49-^744 



BIOGRAPHY 
ISIoqrcfhical iktichfi rr<nir»d on raspoaubl* ln»««tl»alor osd principoj pro/tulooaj ouiaami onJr. // lil» ii o raqatn lor tonowal 
titUilinq ttsonttaltr tha tamm vortoaamt at prvYieiuJr- bloqtoptueoi skolehoa wiiJ oof bo nocottaryJ 



1. NAME 

Kclcn K, ZaxTY 



4. EDUCATIONAL ftACKGROUNO iCoUog* ood/or l/oJrorsitT/ 

Uaivcreity of Tciaa, .l.A. 1949 



2 AOORESS 

Childrsa'a Ilosnital Fvoaearch 



1. ASC 

33 



5. RESEARCH TRAINING (iiJ< o< iiuliluuona. rcito/cji dirvctor. lubiocl oad dotos/ 

K.cscarcb Sdutlsto :::iochc4Xtical Insdtuts, Univeroity o£ "Ssssia 1947-53 



i. OTHIII INFORHATION tlAHiNa ON auAuriCATiONj iHoMpaat oppeialanu. praMsaional locMlMs. ipodaJir board. *iej 

r.cs^arch Ai:coci:it3 > Childrsn's Ilasidtai Tvcocarch rount^atioa 

A.-^cricsa .Vscocizition ior tlic Adva^iccncnt ox Scisscc 
CI ---.a -wi 



7. •■■LiOGRA^HT iD« aot Ust moim than loa pubiiettUaaMt 

Lidiviuoai Metabolic Pzttcms aadlCoT.-.aa ClBcaso with 27. iv. J. xilliacaSt aisa 
other aiticlso oa t jcoaiquc oi paper cbror.iato^anhy. 



OTSG FORM 

I MAW «V 



t08c 



PaCVIOUS KDITION* or THIS rOIIM MAT BC U««0. 



341 



7435 Fair Oaks Drive 
Cincinnati, OH 45237 
;^ril 6, 1994 



Dear Congressman Mann, 

I am writing this letter as requested by your office, to be 
considered by your committee as an addition to the oral testimony that 
you will be hearing in committee. 

I am a retired oncology nurse. I worked for twenty- five years at 
University Hospital. Ten years were as a staff nurse and fifteen years 
in Radiation Oncology. 

My employment covered the time frame of some of the Radiation 
experiments that were under the supervision of Dr. Eugene Sanger. 

I did have personal contact with one of the study patients, and it 
was obvious to me that she knew that she was on an experimental 
treatment. She spoke openly and appropriately about her illness and 
her treatment. This indicated to me that she was a willing and 
knowledgeable participant. Her family was also present. The day that 
I took care of her she was also being interviewed by a psychologist 
associated with the project. This would also indicate that this was a 
treatment and an experiment that she had consented to. 

While it is not always possible to draw general conclusions from a 
particular event, it seems unlikely that they would only get informed 
consent from this particular patient. It is more likely that this was 
the procedure for all patients on the study. 

In addition there were three children treated, one of whom is still 
living. At the time that these children were treated, a diagnosis of 
Ewing sarcoma was usually a death sentence. Frequently these children 
suffered mutilating surgery to no avail. When Childrens Hospital sends 
a child for radiation it is only after much deliberation by the 
physician and appropriate discussions with parents. They would never 
send a child without the parents consent. 

I feel that the physicians involved conducted their work in a very 
high ethical, professional and caring manner. They do not deserve the 
criticism that has been thrust upon them. 

Yours truly, 

Sonya G. Margalia, R.N., O.C.N. 



342 





-S 



rs 






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o 
m 

I 
If) 






o o S 

s S I 

§ « f 



m 


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o 


UJ 


<M 


2 




U) 


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343 



OEMHTMENT Of THt ARV.V 

OFFICE OF THE SUS'JEOS -JENCHAL 

l)E5£AflCH AND DEVEICMENT DIVISION 

AASMINSTON 2:. D C 

APPLICATION FOR RESEARCH CONTRACT - PART 1 



Tirtt or raojccT 



form Aoprot 
Budatt B 



urcifri .\n. 4''.H'*.-ii I 



00 SOT WRITL IS THI3 iKlLi 

3 mw ^ XNtarAt, 

ceitriiAer iiuiiita 



, -1 •»- 



Mcta'aaiic civn;;oa ia ilomaoa ioUo^ioc Total Lo<if 

x-i^2a 



I i' ,°"» ""'AACH C0»I>»CTT5 
! llfllH 

1 iTcbra^iry 1V5; 



I. KAai Ana offieiAt rotirioii of »un><«iiii.( m»nnoATo« _ «. bati or AprucArioN 

Hugcne i^ £&c&::=r, : :..J. . Acoociats Cliaical Profcssar o£ 



25 Septcnbor Iv JJ 



(. ramciFAi piortuioAAi. AuitiARr itj 

CcorQC .^. Cua<.-t* :.i.ii. , Prcicssor of ?>cocarcb Pediatrics 

Hcloa Xm ZcTT-ft ••••A. • Ilcscarch A\88aciato, Children's I^Zospital r.cscarch 



■ y \ ' 



liurolU Parry, :.1»D. , Assiataat ProXcssor o£ Radiology 



«. OTNII FAOJCCU III VHICH TOU All FAlTlciFATilia ANO touKI OF •UPPOUT (Olhtr ganmmml amiracu or/uiuii/rsni eivtUan /oundatton,. t,r 

a) Lici'icucj q£ iCcoplaoia ia IrraOatod CUildxca; cupportcd by ICational Iac:itutc.s 

ci ..jalth, ?.iI.S. , C-2;73 

b) Trcpiritioa oi Ilaadbook on ..Icilical Acpccts of r.adia.;ion .".cci-cata, aarnoitiC 

Uy J.Z. .-ta-uc i-acr^y Co^^^^ccioa, contract no. -il'Cjj-iJ-SiCo 



7. HAM AaB tocATioii or miTiTuiioii wmai «oii> wiu ic ruroaaio 



ilojai-C.c 



zis oi ."Uciolojy, Uaivorcity c£ Ciaciaaatl. CCUC30 oi ..'.stAcins, 
;i3^, Cuio 



1. AFFIICATIOII APPOOVIB iT OFFICIAL AUTIIOIIIItD TO liail 
roo INtTITUriON 



KAai ramriD OA npiB 

C'A, 



Stanley L,. Aiorot, Li.D, 



OFrrclAL TIT-_1 

Dcaii, CoUc^o o£ Mcdidao 



mSTITUTIOM 



Ualvcroir/ o£ Ciocinaatl 



». APFUCATIOR AFPAOVID IT HCAO Or DIFAAririllT WNIAC WOK 
IS TO tC FtRrOAHtO 



KAm FUNTCD OH TTPIO 

ScajaTnin iTclcon, M.S. 



-/ 



y L. 



OFFICIAL TITLC J 

rrsisfsor oi :>.iijla-jy and IIccc c£ 



IKoC'lf'*' 108 '"•V'OUO tOITIONO OF TMl. roilM MAY Bf u»tO. 



344 



DEPARTMENT Or THE AOMT 

OfffCE OF THE SURGEON 3ENERAL 

RESEARCH AND DEVELOPMENT DIVISION 

WASHINGTON 2S. 0. C 

APPLICATION FOR RESEARCH CONTRACT - 




Form Approve 

Budett Bttrtav So. 49.R3U 




PART II 






TiTuoFpauicT •^fj^tyj^ie changes ia Hu.-sans £oUo«iag Total Body Raoiatioa 


FUNDS REQUESTED (On. rear only) 


REOUIREMENTS 


BUDGET 


■lauuTio 

(From 

Offict of Thm 

Sttrgeon Oonmrai) 


OTMIIMURCU* 


1. PIMOMNlw (Liu pOMiioiu, taiarns, and uammt oj projtuionat fMrwoniui, if knowap 

Tcchnlciaa (fulltimc) 
Technician (iullti -ic) 
Phyeiciot (rjart tia»e) 
Qiniriaa (r»rt time) 
Statioticiaa (nart tiaie) 
Socrctazy (part ti^e) 

total 


$ 4400.09 
4000.00 
1000.80 
2000.00 
1000.00 
iSOO.OO 

5 13,vjC. uO 


i 
Univ. Cinti. 

It •» 
If II 

If tl j 


M. ..u.»..T o,.nuz., -^^^odcliac oi laboratory roo..i i900. 00 ' 
Dcnalto.nctcr £» filters v*.oj. i,u ullia'/iolet la.nTv^O: 
Ccatri£u-al chrarnato-;raph 253. CO Van-'J^lylio apparatus 
Freeze urylas apparatuo £t cUro^-atasraphie 

Vaciv.i -,» p'ii^p 200. 00 calu.'.-uia 
Ilcfri^crator 250. DO Colox-i^ictor 
Spray criio-icat 150. CO total : 


.SO 

.isO.OO 

ZC3.00 
<SC;.CO 






1. COIUUMASLt lU.PLIU (Ittmuff) 

:.ascslla&coua jjlasav/are U fdcropipcttos 
Chs=Mcai3, curo.-.^taararjJiy paper U ouppUos 
Phaato.-.io, etc. 


570.00 

i7';o.co 

200.03 

:^2;^w. 00 




4. mAvCL f^iafc Purpo$€t 

Conferences and scientific ueetiii:;a 


500.00 




1 


J. SVB.TOTAL 


vZO. 220.00 


W^'^'"'' 


•. evMNtAO (EuabiuJtmJ by efficiai auduorn iruA concurrent* of imuuifion or rtttarrh 
!—««». or ptrtmagt of total cost of the proMd. indieau btlotc.) 

Provisiouai ii.,i oi salanes 


4695.00 




7. TOTAL BUDCn tSO'^^' 


224,905. 00 


^^;-Vv„ 


»■ UTiK.ri or FUTuai •louiaiiiiaTi 

(To ho fiUod out only if typo of projoct indteatet that u uill coiutnttm 


for more lAan a year) 






Finr AooineiiAL TtAi 


•21,775.00 


■■,.■.. ■;■ 




nceae asmtioiiai tim 


• a, 775.00 


[■^:i-^'-v^;?y 


• (khor Sourtot • from the tehoot. other romrorfs. other Bnvemmem neeiirte*. tntinanitomn. 


«r 







OTSG FORM iQfl* ^Rcvious kditions or tmi« voum mav be tisco 

I NOV S7 .WOJ 



345 



DEPARTMENT OF THE »aMY 

OFFICE or THE SURGEON GENERAL 

RESEARCH ANO DEVELOPMENT DIVISION 

WASHINGTON 2i. 0. C. 

APPLICATION FOR RESEARCH CONTRACT - PART III 



Form Ap pn 994 

Iii4«« fiuMn No. «l IIM4 



^^ctaboUc Chan^ea ia Hmaana FoUavrln<; Total Body Radiatioa ^ 



RESEARCH PLAN 
ttmtlm4m fca tXuM i. M i nti i mmM. ■■ ! >■ < ■ mi mm n 4mtm ia iiiall inami— n i 



3. Sclcnti2s bacfeTTOond. \. 

Several rsnorta have described chaa<;sa In nitro^ea ia«»tabolia=» followinj 
irr ad i a tion (1,2,3). /Ol have chovTa iocrcaso in nitrogen oocrctioa £oUav,in7 total 
body irraOatioa to various laboratory aai.nais. Mciiord and : lartcaa (-1) bavc 
studied a=uao-acidaria by paper chrosaato^raphy ia rats. IZaiz and Ilastcrlii (5), 
and :io.yinoi..iaaii, licco and Xiolfsiaa (6) bavo studied a^ziino^aciuirla following 
radiation ia ba..iana by mcana oJi paper cbro.-nato^rapby. ilcx;.ipcl^iana, ct ai, ^ 
£ouad a.^aiuo-aciduria ia 3 oi their 9 cases. 

ICats aad llastcrlil; reported incrcnsos oX as hirh as ten ti.Aos nor.-nal values 
oi total tL-jiy a.-.iiao acid cscrciion ia -i patlsnto. Coaatittea oi iocividaal a-ono 
acida cixrctcd varied itovi Z - k,ii ti..ioo aoraal values. A^aor-nal values v.\iro 
found as early as 12 Uoura foUovyia^ csnoourc, and incroaoad lovolo persisted lot 
as loaj ao 5 siontUa. i;o dirsct quaatitativo relation to radiatioa daoo could bs 
cstablicacd. 

TJicsa iiauin-TB 8a_:3e6t that a^-Aiao-aeidoria may sorv3 ao aa iiidirater ox tlij 
bioioji=ai rjo-wasa oi hu-.iana to irra-Oatioa. Tho reports ci a-Uao-aciiiria ia 
bu..-ian3 aavj tjocrioad tito tiniia^a in ia^viduals cirviaodiu rcactar acciCaato 
(5,tJ aud uo coiitrol .-.icaoure:-AcnM \.oro poosible.. ihc yropoocu iiivesti atioa 
viil iaci.._j studijo oi arrdao-acia cz^crctiaa bcioro aad aitor irradiatiaa faoU to 
tae v.dslo ;.ocy aad to portions oi tho osdy. Tho urlaary c:a:rcUou of ai.iiao acii,s 
v.ill b> -ijcsurad both by paper caro^-iato'irapay aad total a.iiuo acid aitra^^a i:. 
ordar to ilud a r jiativcly tirApia teeiuucuo ior biolo-;icai o^jcto of irrac_i:iiiaa. 
2i';aiiic£:it iacrcaaos ia total aiiUao addo and iadivioual a:i-.iao acids v.iU Li scm-i.c. 
The a.-.iiuo acid levels will bo co.:>parcd is Icvols oi croatiaa (10) aad area (il). 

These Btadiea vdll bo valuable ia tho uadorataadinn o£ tho ncehaaiai-no oi 
amiao-aciUoria. r>roli:aiaary atutioa by our jjrouo havo do:nonsti-atcd that trariti :» 
amiaa-aci^laria v.iU also occur v.ith ejasnsivo eor'^ical proccdares and v/ith in-ccti- 
Etudics of 5 pati:;ato cnpooeu at tho Y-12 actidoat at Oak .dd^o ia Juac i'J5.i slwv.si 
elevated cscvctioa oi beta afoinoioo butyric acid with levels rolatod to tho total dj& j 
received by tho individual. 

4. SeicntL'ie geooc of tha Proposed P.eoearch. 

/kiviino-aciduria ioUov^inT irradiation has boca roported ia hu.naaa aad 
aai.-nals. Tha purposes oi this iavcoti^atioa ia to atudy this iihcao^oaoa to 

(3) 

°^tl^°?" '083 '•■V'OO. tOITIO«« or THI. ro«i M»r M U.«) 



346 



nON l« COM^LCTID RCMOVC LAST CO'V rOM VOUM FILES- 
CANBON PAPCK AND NtFLACC FROTCCTOR SHCCT 
INAL AND MASTKR COFV TO OFFICE OF THE SURGEON GENERAL. 



DEPARTMENT Or THE ARM* 

OrflCE OF THE SURGEON GENERAL 

RESEARCH AND DEVELOPMENT DIVISION 

WASHINGTON 2S. 0. C. 

APPLICATION FOR RESEARCH CONTRACT - PART 



fn 

lad«« fai*n Mo. 4>-ll)4« 



TITLI or FHOJICT 



Icta'voiic Chan.2C8 ia ZIn.-n.ino jToUowin^ Total ijoCy I^diatloa 



RESEARCH PLAN 
rl—lR^« W l.* s i > iiRil . ■ R i nl l* Ola*. ■■Ifciili ml Rl— >dR»« is dttcU. sivaiilCRacR ml Ikim IR — i m fc. OM TtfdWwnl rrrrr. If ■■irimiij J 

ducicato corr.a of the ;i-icchaaio.-.iB reapoaaibla for amiao-acitiazia a»d to dcter..u.ic 
v.'hcthcr ii 13 a practical biolc^ical tcct oi raciation cizpocarc. 

The DccJTn of t!ij ~TD'nc2:i\ r.jciai-ch is e.s loUovvs; 

1. Co.:-paricca oi tocloirucs lar d3t3r.:iiaatioa oi. urinary a^iiao acids b-/ 
tlis Vaa wiyhs aac cliroriat^-rajiuc tcchsiqucs. 

2. Eotsr.-.unaCisa cf cucrcUwr. c£ urinary am<nf> acido at various dooa^es of 
to'.al bctiy ir;aui?.:ian. 

3. A Cit<2.C/ of tho clTucts oi partial versus total ixicly iiraCiatioa oa uriaary 
a..-auu acid s::crcti3a. 

4. Etudica of tlis i..\r.iune :noc!iaai3.-.i3 of hustaas recci.inj total body irratic:l^n.', 

Eiljctlo:-. ■-,; ~ati:nt3 

Pati^-ts io-.- total b-dy irratiatioa will bo li:.-utcd ta r.dilt .riaZcs %7ho have 
prav";i ...ctac'^tic :..aii--.ia:i-jy bat arj ia --od a-.:triti3ri:il o';atc. ^.i-i ctuCicc \.ili 
bj li-u'.^J. to ..-.::-Li3 jccauoc oi U;; \'-'.ri2tiLias ia a .-.iao-a:ii'.'iria isiiatl v.iUi t.ta 
r.-.caotr^-^ cyci: i-.i •..'o.v.ca. 'i'li-cj ;_;c:tiia;G v.iil as uc:d ijv 7-r :-C3 i aad ;;. L^ r.ari 
3 ...al-j -.2i.^.ts \.aj aic recjivi_i- li.ictiia therapy lOr ace -.Ifj-ia viii ai=3 ba 
i^cl'j-.;^. ....;wc; : ia c -jjcial caca- "3 ajtcu bcxow, -ati-rit:; •-.i..:i i-/ .ip'aa.-.o.s w^... 
ast L^_' iiz^C ia tli.:c; ci__icc. ..U yr.ticuts v.iil be liscr,italiso>i .--.t tliD Ciaci-.r.-.li 

Gcajral II. J^iiiri. Tlisy v.iil ;:av3 ::ictorics, r.Uycical c:r\ i.iaatioc^s, ro-tiiic h: d.- 

tolojical a:^C urias ct;:Cice aad c^:r la.^i-aury ct;iciics as accdsd. 

Factors for irrac'.inrisn arc ao foUovrs: 

V.'cstiii.;;houoc Cuatirocoadcx ccastsat notoatlal thcreny unit 250 ITV', 15 I\Ia, liltr::^.-.'. 
2. i.i.n Ca *• 1 x-i_^ /U. , il.Y.i-. 2.0 .ri-.\ Cu. TwI^ 2wU ciu. AlEo total body 
irradiatiia ^.ill La carried oat v.iili C-jbalt CO telof.iirair/, ;.Ioa3ure.:;'iijt3 v.-iii Lo 
cacclcid by tUa Victcrain cc.-.dcacar v-ui^tor aad caiibvatcu I^:aui:i dosi.T.atsrn 
U£i;i3 u'jicoaits aiid v.atcr pl'jato-^o. Tbs tuchalquo of irratiroian \;ill La cL.iila; 
to t.ot of winclair t: Cclc (12). 



Uriao itifioo 



- gricon of r.tncr Chro ..atJ Tr£-<hy aad Tot-l '. ■■ii:;> : k .■ id I.'ilro'-rir. 



•- .'J. 



i ..o '.rr.u-.c of i a.liit ■.••ai=c -..ill n-zcivc 22 r cI t-.ita: en "v -r-.:.-aja i;i rx .'.r. J ; 
doo=. v;iC-o A v.iil cia:.ist ci • r.:i;:;.c -..iiu rc-ativ^iv ra — J».-,;-ir..~— , .c..i;;n i -. . 



347 



COMFLCTCD RCMOVt CAST COFY ro« VOUH riLtS 
•* PM,mtm ANO HCM-A't P«OTtCTO« SmCCT 
O MASTEII COPT TO Orrrci OF TMt luasION OCNC** 



DEPARTMENT OF THE ARMT 

OFFICE OF THE SURGEON GENERAL 

RESEARCH ANO DEVELOPMENT DIVISION 

WASHINGTON 25. D. C. 

APPLICATION FOR RESEARCH CONTRACT - PART III 



Form Approvo^ 

ladv>l liu*n No. iillU4 



TTTit or "OjecT 



— ctabolic ChoQQCS ia I-IaiAooB xToUavaag Xotal Isody Rauiatioa 



RESEARCH PLAN 
dan ts li il n i r s«mt«c^K« «# lAia li MunA . ITw 4 



BtoirtsicU, bowel, brsis) snd Group a o£ patients vith highly radio- Bonaitivc tu=vo 
(lymptiouiaa). 

Prior to irradiatioa uriacs v.111 bi coUcctsd £or sc^-eral days to oorve as 
coatrolj. .-.U aria=3 v.lil bo collected for 24 hour pcriodo. /ji aiiouot iro-» tho 
early -xoruia- lasuia-; sa^mic v.iil b: r-iri-cratoU and tlia rc:.iaiacir noolsd v.ita 
tho 2.- hjor uiiia colaw. Tim ^-r-s .••■•^n ..j.> •• i._ -.-.i - . . ' . 



riio \xi.i:i-3 v.iil tUca be ccUjctcd. rc;-::-";ratod, nooicd 



-— •-->-", J ..iii lata wj c-iijctcji, rc;.:\;-";ratoii, r^ooict 

aad iro==a tor tua 2-i-hour pL-rio-a. UI ca.r.pics v.ill be aaalysca la tri oUcate by 
both tcc:ijiqu=3 ior ta=tia-r JUid pooiod ^.-it-isa. i£ the iaitial iac:iu-: c?cci..i'ja 
pro-.-idso caou:,:i data, tho tost caa ua Bi-vOiaod. 

Tct-d uri-iary ar^oiao acido v.ilL be dct=r..iiiicd by tlic metiiod of Vaa Elvijc, 
-•.lacJT.r-ca a::c Ila.-.ultoa (7). ?-..o a-ca=iaaal «:^=r paiUdoa chro-.^ta-raniiy 
v-oil be cirrica cut accorai^ij to thj ..^.L;ii;:.3 o£ I,loc:;, wtrr i.-.-. aau -v.ci j (J)'. 

The u: Iioar tiriaca -iill bo aaai^^od for orlc acid, urei crcatiao, crcatiatic 
cau tatai ii'.ti-ajoa. /ui a-te^-ipt x.-iU bo i.uim to r.«uatam tao r-ati-ata ia a-.tjrosj- 
i..^tijiy tlii &a..iO citro^ca ctiuiiibi-ixii. 

i:i^ %-ali;s o:ytaiaod by tio two r:-.ot:;£U8 v.iU be co... :arcd by aaaly-in o£ 
x-artaacc r.:id by «-;ter.:-aaatioa oi rc.jrcosica cosiiiciar^is uJ t.io \-=.iu^a o: Oo \ -" 
wi:/i:c ::io-.aou vorcao tasoc oi cUrt, ui-.-:ra:j:i>-. la ^w^^ ;a ca..-.no.ricca or ^ -i'y 
zci^ o:s:r.;aon ia rati^aco -.TiUi Isio./a i.,.,-.i-icti=a ot iar- .- i.iasoio ci t«.ior 
(v^rou? ..) caa uo co;.iparcd to laoco t3 v.:ij_» cucii a paoao^.croa is ujLL-^ly ( Jra. -..,.. ^ 

Part 2. 



I)it=r i-ltat ioa o: ::;:cr>.ti::i ef Urinary Amino /.eijo r.t Varicus r.as-.' 



Patiiata to bo otudiod viU iaclada thoso inUiv-idaala v4ta ractactatic aeooiac • a 
ana alco r^aticats v;ao &ro rccoivia- vaulaiiou thurapy ia ca a:tc--.T3t to euro o- 
paUiato v^ious ncar^siao. .--aacr.to ia ijia atady wiU not Iva/a llad previiua 
irraiiatioa so ai tj avoid carry-over aij^cto. Ia tlu iaiidal csiocttja oi TxxUoits 
i-o -i-ou.> a: paaoats vavh «..otaD;aUc aaopxaoms caaaot to cO^ctcd at raaco 7» 
..o.A a nir::.ai vcpoUitiua ior iuciusica ia tas study siaco nor.i»al iadividuala cai^oc 
kjo j;ivca tutal l^ti^y raLOatioa. 



Cdcctioa criteria arc aa ioliovc: 

1. "r.-I-nt to iu;v3 nroi'ca ij 
••• 1 :..^.:.t U li;ivj •■•rove:; o 
3. -.•',U;rt to ix: i:i'cia;^-.=; 



*.";23u1b ci acfjj»i£j..\. 
. i — ..icc c; r:cV32'i.:"..';xj, 
i:.-y acti-ivi.Mal s::*".^. 



348 



teiozm rttuming 



DEPARTMENT OF THE ARMY 

OFFICE OF THE SURGEON GENERAL 

RESEARCH ANO DEVELOPMENT CIVISION 

WASHINGTON 25. D. C 

APPLICATION POR RESEARCH CONTRACT - PART 111 



Form Ap^Tor^d 

Sodgtf Bunov No. 49-B3<4 



TiTu or fnojKT . ;^taijolic Coan^co ia iluirjjic r ollowinj lOtal l»ody Tvauiation 



RESEARCH PLAN 
flactad« kavkvressd. fvaciiic aims. aaiAvd* et pncmdvn la d«lail. ^gaiiteaa£» «i thia raaaoich. Om ar l d l t i n na l pagmt. If aMassaTTJ 

The paticr^a v.ill be eclectJcl for thrao oubjxoupa ol total Ujdy irradiatioa by 

raa<2a.-riisa'.iuii. wub^roap A v.lil serve ao caatrola a:iu v.iil iia'.-e ail ---roccdArcis 
carricu out Ciicc-jt Uiat tacy v.iil receive Oiia..! irratjation only. ii_b ;roap :-■ -..ill 
receive 25 r anu .""uj-roup C v.ill lecei va 50 r. ];ach jrcu:? v.iU ccoi-ist oi -i 
jiationts. TUc ^.eaa valuta oi t~tal a.-.iiao acids in tho uririi ox tii3 three '•rs-ips 
\,ill be t=:tta ior ci ■piiiicant ui.\,;r;;:i=ec by aaaiycio oi vai-i-r.ce. :?ab3rojp A v.ill 
be tjJtJu r.-rJ-iEt wib'jraups Z a:iu ^. . -Iia Jubji-oup .J -.".iU bj tcot-d ajaijst :uo- 
^roup C .'urtlur ^roii?" v.ill bo c-adi=d at ICO r aatl 200 r. 

I£ tiiirc i8 ao ci ^iiivicaiit ci-fsrcncs bcr.vcca 3 aaci C, then aCuiiiozial mTb.;;rov.->i 
v.ill bo 5taai.:u at c;rjo3ircc o- J.i.l- s:-.i 2.J v c. taUil b-vV/ izr:i_i:itiaa. Cnn ol 
tiic po5ii_ie rcr.so:is t;iat a rcir.ti;>a b-js\.o-.;a radiation e::'rtiix<rs and a_-a:i3 aci- 
cucrcUoa -ay r_r.=h a i:l3tcaa vTias b.ia./ 23 r o; total b.;::y iiTaiiati'j.a. It is i.T , 
tlda r-j:i=on tl^at tUis:: al.'iUoaal jroj:: = ..-.ay rcr'iirs etacy. •:itiintc \.iU be 
plac-il Li U-C3 ccvcrai ji-oaps by t.:. sa — ■ toc.u-r.ua Ci r:.:MJJ.-a::atiur. as t.»scii.;_. 
abovL. .".aotlicr :;i-oa:j oi s:-^... irra-iatiia coiitrcic v.iil ba pvo.-iii^uin ort^r nit to 
lose Liu~^i.iit.\.v^z(i oi CO .ipariwons. 

.':t tb= caiiciosion oi tlicsc ctu'-ios furU.cr aaalysia o: tho Ciia. v.ill bo carri-jt 
out v.iij calca^adj.is baocu on tli- iiiiojval usso rcccivoa by caca pctuut. Vha 
«loea-;c r-cooasc rjlationsUip v.iil iboa b_- kb;tcr..dacu. 

Tr.rt 3. "t-.'.Oy =-• tli; :T:.::cts o£ i'r.vt^al verbis Tc:-.l :--ot'y Iv:-:.a-\ao& is.\ "i-i-v.iy 
... . i iJ iciu _.:;r_.iJi; 



.."Utcr cuitabla base liae vala.;s arc ostablichcti as d^ssri-id '"art Z, mii'.i-r 
statics v.ill lo carried oat in o-C-r to co..inai-c total bcny irratiution v.itli c;j-:; 
ol localiaeC irvaiiaaoa to ;ivo en.iai iatc -ral Cot^T-zs, - or ca .•---•**# il - priLi-^at 
rcccivee total boCy irratiatioa v.iUi aa Litc^ral uoce of f j,00 J fT^a -i roiint; :;:s, 
his a.iiino-aciuaiia v.iil be co. :parod \ iia tUat ot an iaci-/idual v.ho hao ir^zidv -C 
an eqaai ir.t2::;ral doso vvioi ail ii-ra-iatioi; jji/ea to a iociii-cu r; ;ioa ci Uz coi'/. 
Oac rjrcup ci patisa'.s v.ili rcc.ivo Uis CjSi ta tu ur.>-" £>.bd3. ".en, aaotiier liyaa:. 
to the c'l. Js:, s_:ai;i=i- -roap tj til.: h.a.C a.-.d r.eclt. Tbisc -:.ti j;:^5 •; ill b-iva r.e- 
ter...iiiati-.>.io ui Mi-inary a..-.iJiO aci;:= b— "ore rccciyi:i3 racialias a^id v.ill ba ioU:: . 
aitcrv.-ardd isi* a ijiriod o£ o;ie to il-.rcj yoa.'o. 

t;»c ^.-Et .-jroui to be (t iui;.d -..ii. bs t'.ijcj pati.;:^to \.!i':« v jcci/c i5=:iiii-c 
Irraiiatiw-:-. fj U. :-icLijy= aad ilv.-r. wi;.c : lrr.-.a:-.u:..-.i to '.I'S. v -j.' Ui.-; '-• c--.:.-.\;; 

so FORM . 



349 



jcve last copv fcr your Iiiej. 
:plQC« protector uieet bcio:e returniag. 



DEPAI^TMENT OF THE ARMY 

OFFICE OF THE SURGEON GENERAL 

RESEARCH ANO DEVELOPMENT DIVISiON 

WASHINGTON 2S. D. C 



Form Appnr*d 

ludQti Buraon No. <SR3,< 



APPLICATION FOR RESEARCH CONTRACT - PART III 



TITLl Of PROJf CT . 



lutabolic Cuanjea in Kuraaaa rojiowing Total Zauy ilndlation 



RESEARCH PLAN 



(tM€l.d. tactnmad. omcXIc cdw. mmlhodM .1 «recMh». i. d...U. UnUicox W IU> itmoKk. Urn .ddilisu/ ■»«». U BKumr J 

may ppo\-id3 a .-.-.cchaalo.-.-i for auriino-acitUiria (see Part 1) it will bo valuable to 
dotcri-iiao uu iovoly oi a..-.ino-aciviria iolioviaj tills r/^.c oi irraciation. It w^u:t 
b2 pcco — j.;:oa tuit in arnl'^-iiiT raciatiou to tlic bu..-iaa it is not yaoti^^o to irra-i^ti 
tiic liver -..iUicut irrasiatia ;; t^u; Id^asys and coavercoly onj canrut irrauiats t'.\~ 
luda!.-ya v.i:.i3ut ii-i-itiatin^ tui livor. U thu a..iiao-?.cic^ria is oi t;:o car.ic oi-ccr 
Oi :;-.ajui:u;:o as tliit iound v.itli t;;tal body irr^Oatio;!, it v.iil oa -.^st t.iat irrcd- 
iatioii Oi titlur or Loiii oi t-ic os.;z-i.a is vosp-onciole ior tii^Si iLi^jii-'.o, '.lie 
scccati -roup to bo etuuicd ar= tluo: ir.Civiuiais rsc-ivrx;; ij=.-Ui^=ii racic^ioji to 
tho Ci-.=o.. Li tlis a:.iino-acid:iria a-jproac.iia Icvcia equal to tlijie ioanti ..it.'i totr^ 
body irr-dia.ioa ia co..iparaJia iat.^jrai cosoa, iacroaccd tissue Lii-ca:tciov.-a shouiu 

bo SUSJi^Ct-d. 

rro..i a practical vicv/Toint tlucj tv.'o r^rouna \.ill bj tir.uiid ti.r.uinaniouSi-' 
d;p;;;di. J i-zvaa ciiaicai .-Jitcriai a-.Tjla-Ic oa tas lu-aor Lor-.-ico Oi tao v,iati:;.J;ii 
Gcawroi l.^spital. 

T-art -S. 



la cs::".va:i-jn v-itb Dp. /..J. i.w::=io o* tho rvaao'_iolo::y L.-^vart.r.oat, 'J.l'. 

\:-..\y acal ..jot-avch j-iDcrat:;ry, _ i. y^io::, ;;,', v.c car.u cuir^:/ blood cc.-.-.. 

==. .ijlcz i.j:.- all ••,r.uc:its irraOai — a= c.--;;ci-ib2u ^^ivsvii:.:^-/. ..^...-.-.ics -.iu L,i 
°-'^^-'-"- .■-•^' r-i'^- to ii-rr.uia:ioa, J.-.j: :_,-.r irratijLuoa a_c. t^a cayo aiLcr iiiaw- 
ir;tiaa. ...cy \.ili bi Sir.t to j-'r. i.uoiao ior :u3 stutaos. 



1. 2>ruoc, .■..., iiucicar ocioacc .-.bstriiois, 7:7, l';53, 

2. GusiaiSoa.G.:.., and .-oliitclr/, _. , ....i. J. Vaysiol. 171: Zi: (1:22). 

3. ..hit.:, J,, w'.irr, J...., cadw;a.idjr. Ar2oaau ICitioaai 1-aboratory Cuai-icii/ 

r.^I^ovt, ."v.-b. .ar..'.r>ril l^iiS, -'vr-i. 

4. : •.ci:ord,.w. :j. , ::artciiw, :i.::., .^ci^acc, 122;32/, (l',o3). 

5. .'Cats, _.J. ar.d :iaBtcrlili, ...1.,, J. .^aiioaal Jaacci* LiJt. ,lj:1035 (1925). 

C. Ilon-.ii laa-i, i,.i:, iisco,:-.. a:*d ::j::..iajj, J.C. , ...-.ii. Lit., led. i6:277 (l.Ll). 
7. V-a .I'.-ho,*).:^. , . ^ac.aydoii,:^..'.. aad Ilarailtoa, P.Z, Z, l,ioi. C;iis.i\. 

low: »;i, (IMj). 
C. oovc.d. , ;iad_.i;ia, ...::., :. :.ivjl. Jbo.r*. 211: ::.7(r. il). 
,-. i.ioc.;,. ., J. ,. .iViu..4,... i.. lii'i .-•. -iij, J, , .•. ...aaaal wJ . ^;j<.t CI;r^..;atO£irr. ."../ 

ar.;'. aiici- ..:.c-.i-o:'!.i5rojio, .»cj.-....;ic ."'rooa, lac, ::... '/or:-. Doo. 



-LJ 



350 



■ retnov* last copy i" VC'^ files. 
id rcptaca proier.or sruei oeiore returning 



DEPARTMENT OF THE ARMY 

OFnCE OF THE SURGEON GENERAL 

RESEARCH ANO DEVELOPMENT DIVISION 

WASHINGTON 2S. 0. C 

APPLICATION FOR RESEARCH CONTRACT • PART III 



Form Appnvmd 

«ud«>l ttinm Ha. 4>KU4 



—ctabolic Chaases m IIa.nana c oUowins lotal <^ody i.afiiatinn 



RESEARCH PLAN 
«a«la<« > nt i nu it j«Mi<U alMM. Mikoda •( praradan la daloU, a««ilii'inrn « Ula H»H[|> Om itillHaMi r«f ai, U a 



10. ^\ndcraoa. D, R. C££ccts oi lunaatloa an Creating ..^ctabolis^. r^biation 

r.caoarch 7:JuO (1/57) 
U. I{ay. .^. w. , Harxy, J.C. and rjntftn-iiaa. C. F.adiatiou lUtosarch 6:9u-109 

(1.37) 
12. CiaclAir, '•■'.11. oud Cole, .*.. , Tscliaiquc and CosL-.x'^txy lov witolc body x- 

irrs,diatiou oi patisots. c1m\.' ^v=port Ko, 57-7J ..i^r. 11,57. 



Ii rU M 108B *......«— l.t«.»tMM..M. ...;_».lj;( 



351 



DEPARTMENT OF THE ARMY 

OFFICE OF THE SURGEON GENERAL 

RESEARCH AND DEVELOPMENT DIVISION 

WASHINGTON 25. 0. C 

APPLICATION FOR RESEARCH CONTRACT • PART IV 



Form Approved 

Sudqtl tunav No. 49/1)44 



BIOGRAPHY 



(Bio^nptical sktrciitj n^vind on r«*poajlAi« tnr^tllqatoT end prinzipal proj*uieoaj attittamt onir. /' thiM u a rm^vn tot raiMtvcl 
BtmtiB9 ttmmjaUr !*• Kiffl* pcriooiul u prtnoiulT. iuTraphJcoJ >k«cA«< »iJJ not bm dsouottJ 



I. NAM! 

Eugcao JL. Saca^er, ;.I,C 

4. KOUCATIONAL ■ACKCROUNO tCoJJ«9« aad/or UaJrmitrJ 



2. AOOaCSJ 

r;atIioiBotopc laboratory, Cinciannti 
General liocpitai. CLicinaatl 29, Ohio 



Ilarvart: Cv)U,::-;o A.D. , cu.n laudc BiocliciiUcal Ecieaccs 1933 
University CLiciaaati, CoUeje oi ..liiuiciao, ..l.D. 1942 



i >CSCA«CN TDAiNiHC lUo o< injUtuMnM. nttanh dJraacr, jab/Kl sad dsMu 

t-.tcrr.c CvJiiarai ::oc-;it2i, ninr i-.-.- tj l?/r.-l?43 

--.cciacat i-i ..r.uijlj-7/, Ccaircd ZlasrdCol l;43-46 

CMui ..r.aoicotooc u:ut, .:-roo:;o .\iT.:y ::oopital, 7C11T l';5'l-Cy 

Cc:isaii;=_-.t ovir :icai .'.ccjsrch L'^it l.^:-35 " 

I.i.--cto::,._;aoi5-jtj-:c J.r.L>or5t3i/, U.iiv. oi Ciati, Coll. oi . .wasiao 1950- 

A:=ista;i: .TOicscor o» .^aiolo:j/ i^':;-y7 

/.usoc. wiiiucoi '^i-oijscar ox .Lr.iiolo.;/ 1>57- 

woncultcjit -roal-.j /ir;;v/ Hospital l^iy- 



«.^ OTHER inroRMATiON lEARiftC ON QUALIFICATIONS (Hosp.lai appeimasnjj. proltfijoaaj sociPUcf. tpccioitr b«ard. ttcj 

- Ucncir.j . -ajij tist, wLnci:i.-^.:i: ;: jr.-U IL^z-ltrJ.; 

.>.-Li:;ti3n .-h-TSoict C:ii:ij:cn's ^ . ja-i:=.l, Cincxiaati.CIiio; 

-r-lo-iatc,/, -..:i-ic.iii :_cr,i'u c> ..- .i^i.j-.y , .'.c.-.ib.r 

/;...cric:.--i -.j.::c ;.:i ..ay . ocicty, -.r.aoij'jical Cocicty oi IC.ith ... icriea, ilcalUi 

.'.v/cics ■ jci-tv; .- 1 ^-.m O-^- '1 .- 1 im 

7. •ilLtocAAPHT fDo aof Jul aor* thea Ma puAiicatipBjj 



1. wic.i-jir, .w. i<. ,«.t ai, :,.n:r :jacy ..luaourca aj^d prccs-otlona ia r^awu.-.i acciL. i;5. 

Jour. ...siu. .^sca. lly:;i;-^iJ Jup.j 2J, I'.CS. 

2. "csoitsoi raora^y Y.dt:i-l-a;=.ctivoI.diat.l..iiaIly:>crtJ>'roias.-n. Ciuo itat^ 

J-ar. ii'j:2o-^/, Jaii 1 >!':-. ....L. w.-.ja-^cr, ct al. 

3. Sacn:.cr, -.I,., ct al. i.ctf.rci-.ivc'o l.i:>..i5c. .•ruUcio i:i L-ia-Tiocis ar.L; " ■ -• 

.-.-.cat. .V^iur. Jour.: jont, ...-.J. viijrany U :;acl ..cd. J.....1, :,o. 3. ..-.re - .' ' '-■ 
•1. Prot-cUoa a- liast raii-ticna ir.i . r.■^aa-.^, cobalt-C-, aiid cc=i-a.-.'..137; I.-J., uil" ' 

-u.-^?.a o. -tancu-vrua .jjic-oo:: 51-, scctija V, acci«_ji.t8 cntailia-r- raui^-do ; 
^ ^ lia-aiuB, .opt. i.i'i. ^.vji: V?, -.;_., ct al. 
J. .a.-;;-;.r, .-.J„. vl .-U, Javcii^o. la uJ thi ?rosMlc; Tlicr-.ny v.itu r.a«3ioactivc woiioi 

0. j: ....Li^^.or . .Ci.-u:uria- bac:-. -rouiiii ly ..-.ca.-io o; :taa:.;icai c;..ii-oi clu-.i-t. :• • 

..■-.-i-.J-ur.-.ucm. ,..ai..;;,^:.-,y /: ..ac. o;.. _....;•:•:. :..:i, :n.-:.r, .L:i. 
». •-■.;. :• r,....^. -.-t ai, -■ •.-.nt.'jc ..r i.:..;..:i: :;jj Id.;.- ;•..-.- -.;.,. ..:_.^ ;..._; . .^.. . 

" • ■..:;:irw- i;i t:io T.^r.-.c^c. v.. iv.v- -i-. > - ■, - -■; ' -• 






<:.-:i. 



Sa FORM 



352 



DEPARTMENT OF THE ARMY 

OFFICE OF THE SURSEON GENERAL 

RESEARCH ANO OEVELOPMENT DIVISION 

WASHINSTON 25. 0. C 

APPLICATION FOR RESEARCH CONTRACT - PART IV 



Farm Apprar«d 

Badgvt Bunau Ho. 4S*ff?44 



BIOGRAPHY 



IBIovraphtcat i<<Kh«t rxnind oo latpoasifc.'* IsntUgmot and prtacipaJ protosiional anlnaui ooir. " lliii U a raquan /or r*»woi 
atiilaio9 AsMauaJJr t^a Mra« p«r«0aA«i a> pr«vlou«i)^. biOTTOpUcoi <Jc«le^«s wUJ oof bm m»e»uarrJ 



t. NAMI 

Ouc6t, Ccor^c ...artia, ..:..S. 



2. AOOKCSS 

I'o'inf.itioa. Oinciiuati 2?. Cldo 



3 «iC 

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4. lOUCAIlOKAt I»CIIG«0«NB (CailtT* aa4/»r UainiMUrl 

Clao "..'..sli/aa University, l^Jlav.arj, Cliio I'ilG-lO 
Univcrsir/ ui OiacLioati, -<.>i. 1>2J 

" " " Coilcjj oi . .cciciao ..:.0. Iv22 

•• " " " " '• ..:.s. r;23 



s. RCSIAACH TAAiNiNS (Litt Of tasufutlou. rvMarch duacfor. sabiaet aad dat*«/ 

-Lici^uiva v.- ;;i.ral -los^i'-^al, :.il :,ii..;.t i;i " citliuiajy aiiu I-istnictur Tathol^ -y i'. r;:-l. ..^ 
Listit-t ."- .;; .u-.-,.jrus=wli,i-wl iu..i,_^Uov/ Oii the wO-i-.-ausioa icr ..sliw^^ in ■.,_i_^ia.. 

_Cuc::.i.jr.:.i -'o'or.aauj.i 1\,Zj'x,Zj 
-jostcii v;:il,.'.r.n'a .'.^oiitsl, Lilnvn i.i ."•-i."iitrics, .,>..c£vlv;iit lictorioiorpist aad •.j.i". '.. 

Li .r-ci.iii^j y, ..^rvnrti . -liccJ .ci^^v/l i;-6-lJ-? 
'Jaivciriiy oi ^.iacimr.u, .^lijjj o* .^-CXuLm , ^.-cr-.t, oi "^oiatrico: Aba't Piai. 1.. --^ 

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OTHCA iftFoauATiOM BUYING OX 0UALifiCAriO'.& (.Soip.'ioi appolajmaais. ptotttMtoaal soclatJaa. Bpodattr boaid. aleJ 

... . ..— — ;.^ . .^. V ._ .I.J.. o. . — '..wiii >.'..;:u.°..ir'_i 1/ .;.j i rl^ ■.(..■•.■;. 

:s. iai- — i.-i;iic ...;j;.ai-cU(V'r..ii_ .;-.t l,-i;i) ..■;•. .na -J 

..1, Tjc. oJ _i-iijical whs .'aciu 

;rti-'i-i.. ^i;..-.a:i-.. ^i t.ij ii-.x. ..onii oi Pstiiatvics 1'536 

^^.C.i.'.i .. ■:•.••,' . i-.'. _t.-3 



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•ituOGRAf HT (^0 not Uxt mon ihaa tao pubueaucaMJ 

Ciwiu, ... . wt ;'.i, C .tri. : _.• .;.\.!ijc .-or tlij u.ijr -iiiT.tian o_ the V3i..i..'.tf o. i... 

iu l>i^.\.u, J. j_iu, C: i\<ii.i. oJl. Xy :V J7-Til'7,^'.;jril 1< wi. 
Ciajci,C« . . • (C t r.la ilcv.utjij^ic ..i.i,li:)iis iu d. :.'CtL:'; r.atiiaw.iul aac.'.'daa i:^ . '.'; 
tii.-:i: il\i U'j\.-C7 ua3noi;tic ..i^t'a.>ds, lVt!i aiui. con... , . iil.uiil; ..^c.'.iorial . 'inc. 

Uu.:;.t, C'...l. ..t ai, C7- ;-aic aciu-t-jliiLlc nl-.os iliarus co .i^ioauda oi ths Lilov;!. 

r '••yji.^i* .fcCVa m1;**1%/***'. 7, .'..Ay l/*.4« 
Cucct,'.. . ., , i_i al, ;.iau-'ac co .ie.: .-...l.&'joli': (l.rs^~s..ic^ii anC priucialce A.or 

cov:-..cti.-j f.i rr»^y, .•..:..;. ~C .':Vi j_-w.f ,i,-:/. 
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353 



OEFARTMENT OF THE ABMY 

omCE OF THE SURGEON GENERAL 

RESEARCH AND DEVELOPMENT DIVISION 

MASHINCTON 29. D. C. 

APPLICATION FOR RESEARCH CONTRACT - PART IV 



Form Apprervd 



9I0GRAPHT 



IBioqnphieat tkmuhot n^vitmd on roxvomuhlo tnrowliqatot aad priacipal prolontoaat OMaiMatM omlr. tt tUt is • t*^90i 
^auaiaq •inauaJlT Ik* asa* vmnoaaol oa prariaaair. tia^ivpttcal <k*icJwj wiij sol b» mmttarfj 



M tor MavwoJ 



I. HAMI 

Hclca K. ZosTf 



t loucATionAk tACiuauno iCeli*** oadyei VoinraifrJ 

Univcreityof T>::aa. .-l.A. 1049 



2 ADDRltS 

Children's Hospital Hoaearcb 



33 



S. ■CSCMCH TMAiNiiic 'Li^ •< IntTlmftftai. navofcA dlnclor. ja^ivct ead dattu 

Kcaearcli Sdsatist* SlochCi7>ical lastituta, Unlveroity o£ Tsaas 1947-53 



•. oTMca mroaiuTioa UAiiii* en euAuriCAiisNt iHat^mot i 

r.cti^rch Aucociata • Ohlldsan's Ilss^dtal risecarcb <oaa<'.atioa 

A.'Acrican Association ior the Advasco.'Acnt ox Sciarxo 
Sl-r-.a .g 



;. IIIUOCAAVHT (O* Mi iM I 



IiCiviilaal .Motabolie Pcttoras aad Mar.>.an £lBoase vrith 2r. iUJ. wUliaias, also 
other articles on tJchniquo oi papsr cUro-uto;3rapby. 



OTSG FORM 



tOSc >«t w iou» tDiTiow» er tmm re«M mat ac u*<a 



354 



TAFT, STETTINIUS & HOLLISTER 

1800 STAR BANK CENTER 
42S WALNUT STREET 



WA8HINOTON. O C OFFICE 

SUITE 600 — tflS INDIANA AVENUG. N W. 

WASMINOTON. O C 200O4-29O1 

202B2«-t«S« 

FAX: 20S-347-341* 



CINCINNATI. OHIO 45202-3957 

513-301-2836 

CASLS: TAFTHOL TWX: aiO-4at-20S3 
FAX: ai3-a«1-020S 



COLUMBUS. OHIO OFFICE 

2t EAST STATE STREET 

COLUMBUS. OHIO 4321S-4221 

•14-221-2030 

FAX 0)4-221-3007 



NORTHEAN KENTUCKY OFFICE 

THOMAS MORE CENTRE 

2070 CHANCELLOR DRIVE 

CRE8TVIEW HILLS. KENTUCKY 41017.3401 

OOS-331'2030 

813-301-2030 

FAX: Bi3-Sai-0013 



April 22, 1994 



Nlchole Jenkins, Esq. 
Staff Counsel to the House 

Judiciary Committee 
Subcommittee on Administrative Law and 

Governmental Relations 
2138 Rayburn House Office Bldg., Room B351A 
Washington, DC 20515 

Re: House Judiciary Committee Subcommittee on 

Administrative Law and Governmental Relations 
Hearing on Radiation Experiments Conducted By the 
University of Cincinnati Medical School 

Dear Ms. Jenkins: 



It appeared to me from some comments I read in the press 
that not all of the subcommittee members were aware that the 
Department of Defense had been told very clearly in 1962 that 
patient selection was made only if there was a "reasonable chance 
of therapeutic benefit to the patient." 

The fact that patients chosen for the post-treatment 
observation of radiation effects were being chosen from a group 
receiving therapy is reinforced by the reference on p. 5 that the 
use of patients receiving therapeutic radiation may be 
introducing unrecognized biases into the investigation. Those 
statements were made at a time when there was no controversy 
surrounding this investigation or the source of funds for the 
post-treatment observations. This report was authored long 
before the existence of a faculty research committee. The 
statements, therefore, are entitled to a great deal of weight, 
and there is no legitimate reason to challenge their credibility. 



355 



Nichole Jenkins 
April 22, 1994 
Page 2 



I would like this letter and the 1962 Report included as 
part of the record. 

Thank you for your help. 

Sincere!^ yours, 7 

''^■^ 

yc. JosepB Parker 

RJP:vra 

End.: "An Appraisal of Human Studies In Radiobiological Aspects 
of Weapons Effects" November 14, 1962 

cc: Eugene L. Saenger, M.D. 

Congressman John Bryant (w/encl . ) 
Congressman David Mann (w/encl.) 
Congressman Rob Portman (w/encl.) 



iiM- 



356 



AN APPRAISAL OF HOMAH STUDIES IN 
RAD10310L0C1CAL ASPECTS OF "WEAPONS EFFECTS 









: : * ." ?>■ ■■ 



PAdlolsctope Laboratory University of ClaebixAtl 
Collcgv of MadiciiM 



■» , i.r •.-•■. • . ■,■■ ■ 



Prepared for DASA nadar CoUract pA-49-144-XZ.0S9 



Novenbar 14. 19o2 



357 



AW APPRAISAL OF HUMAN STUDIES IN 
R^DIOBIOLCXSICAl. ASPECTS OF WEAPONS EFFECTS 

A. Introduction 

Thia memorandum consldara the •ignUlcanca of utilising human d*t& to 
determine radiation effect* and to develop appropriate coontermeaaoret in 
relation to weapons effects. There are two broad categorle* of atudy which 
require elucidation. One concema Itaelf with effecta on hamana, the second with 
effecta on the environment in which human belnga exlat. 

In the Initial conaideratlon of theae two categories one caa reaaonably 
aaalgn cifecta on the eko-ayatama to groupa other than the Defense Atosalc Support 
Agency. Theae atudiea of effecta on all typea of flora and fauna are of great 
importance and little conaideratlon has been given to the long term effects of 
high doses of radiation. 

The primary problem of human effects of high doses - both acute and 
chronic - rc<iuirea considerable further analyais in regard to proper allotment 
of research time and effort. The obvioua concern la the diviaion of support 
between animal and huirtan iaveatigation. 

B. Philoaophy of Approach 

In any problem in radlobiology one la Intereated In two aspects. The first 
Is the discovery of general lawa or prlnclplea which are eaaentlally the aazne for 
all animala. all mammalc, all large anlmala. etc. The second aspect is the 
docximer.tation of specific information concerning man. If a general principle can 
be demonstrated in several types of animals, one may then assume that it is probably 
true for humans. For example, repeated studies have shown that if an anixsal 
is placed under severe stress, e.g., exercise to exhaustion or thermal burns, its 
tolerance to a given dose of radiation is less than an arimal lacking the same 
stress. It la reaaonable to aasume that human belnga under stress tolerate 
radiation leaa well than a healthy individual. Cualitatively aucb a concept is of 
great value) quantitatively it la of less help since one is not able to extrapolate 
the specific stress effects to different species of animals or to people. Nor is 
one able to predict the effect of a given stress la a human being after obaervisg it 
in an animal. Anderson (1) states that the use of laboratory animala la radiation 
research progranunes is necessary in order to obtain a belter understanding of 
a number of the basic changes resulting from radiation Injury. Extrapolation 
from animal to man is different If not impossible. 

It is, however, quite apparent that many high dose effects simply cannot 
be studied in humans because of obvious humanitarian considerations. Cn<9 cacsot 
subject people to whole body doses of 600 rad although sucU a study would be 



358 



-2- 



«Btlrely feacibl« ia na %nimkl. Thus many experiments of radiobiological iaterect 
will contlmie to be deae la animal*. 

Neverthelesa, it is eeeeutlal to conelder further well planned atudiei In 
patient* «o long as tke following criteria are ftilfilled; 

1. TiMre 1* a rea*onable change of therapeutic benefit to the 
Pktlent. 

2. Th« likelihood of damage to the patient !• no greater than 
\ ' "•• that enco'jctered from comparable therapy of another type. 

3. The facUitlea for support of the patient and complications of 
' :^l-L':\ treatment eifer all possible medical services for successful 

nMislenaace of the patient's well being. 

The type of patient usually selected for whole body radiation exposure Is 
an Individual with cancer which is far enough advanced either by direct extension 
of tunaor or by metastatic cprrad so as to eliminate consideration of attempts 
at curative therapy. Usua.Uf these patient* receive nonspecific supportive 
treatment or pnlliatirr* treatment by surgery, radiation or chemicals. The 
consequence of these form* of therapy are usually helpful but sometimes the 
sequelae or complications of tha various treatments are in themselves life 
threatening and constitute a haeard to the patient. Hence, whole body radiation 
therapy is no more Ukely to produce untoward sequelae than xaany other cxirrenUy 
accepted treatments «i other typos. 

Animal studies (2) have su<;c«sted that small doses of whole body 
rsdiation actually potentiate the olfect of subsequent radiation given locally to 
tumor areas. In acute ra>^iation Injury of humans interestln,; contributions 
hi.ve bsen made by a number of workers. Hempelmann et al (3) have dsscribtd 
the salient feature* »f acuta vadiAtion injury and these observations have been 
amp'iUied ty Andrew* et al (4) Sbipman (5), Howland et al (i) and others. 
An excellent review adding certain nsw diagnostic criteria was presented by 
Thoma and Wald. (7) 

Observations following therapeutic whole body radiation have been mad* 
by CoUins (8). King (9) and Muller et al (10). 

Althou!>:h too few patients have been treated by whole body radiation at 
the University of Cinciesati College to be valid statistically, we have made 
several interesting observations. In general, these studies have demonstrated 
the relative innocuous natarc of doees at or below 100 rad and have continued 
to corJirm the wnll ksova hsmct^lo-'ical changes. At 150 £:.-i at ZOO rad wo 
have had responses to radiation of the type seen in group U of the acute radLntion 
syndrome. W* have had two cases, one at 150 and one at 2'JO rad, erpire v/hlle 



359 



mAnlfectiag ths hematologic •bnormjUitle* of group m of the acute radiation 
•yndrome. Thas* reapoaaai are in c&ncar patieota •uggeating that the more 
■erioua reeponae may not be due aolelf to radiation. These finding! alao suggeat 
that patient* with varioua lUnaaaea may be unusoaUy aueceptible to radiation 
doaei whereas "healthy' patients may be less affected. One wonders whether 
the effect of proloa$;ed stress as found in fatigue would produce similar effects. 
Searches for biological indicators other than blood changes have to data been 
unrewarding primarily because very few biochemical systems have been carefully 
studied in hamans. Certain indicators such a* urinary beta amino isobutyric 
acid which have appeared to be useful in accident victims, seem in cancer patients 
to be much less predictive than one would have anticipated. 

C. Role of Future Hximan Research In Relation to Remainder of Radlobtology Froffram 

When one considers the nature of the total problem of weapons effects it 
Is surprising to see the paucity of human studies. This problem is probably the 
•ingle most important area of biological weapons investigation to be pursued in the 
next decAde. Much valuable diagnostic, prognostic, behavioral and therapeutic 
information can be gleaned from well planned and executed studies in this area. 

Centisoing and future studies of acute external whole body radiation fall 
logically into the following categories: < 

1. Clinical evaluation - effect of varioua doses en signs, symptoms 
routine laboratory tests or new tests (newer biological indicators). 

2. Metat>olic effects - Effects of various doses en nutrition, fluids 
and electrolytes and biochemical systenas of Interest (including 
changes in the immune system). Use of Labeled precursors. 

3. Behavioral effects - Effects of radiation at various dose levels 
on hunoaa performance. 

4. Dose rate rf^t>ouee - Changes in effects with very high, very, 
low and mlxea aose rates, together with evaluation of single aaa 
multiple doses should be made. The concept of oqulvalent 
residual dose (ERD) (Rept. #29) should be iavestigaUd. 

5. Partial body irradiation » Comparison of effects of shielding 
of various parts of tae body. 

6. PropBOsis • Development of criteria for patient care based 
on the observations from these studies. 

7. Therapeutic methods - Adequate supportive care of patient 
receiving radiation. Development of new naethods of preventioa 
and treatment of radiation injury. 

8. Use of healthy volunteers • Limited us* of normal volunteers 
based on preceding careful InvestlgatiOtt of therapy and accident 
patients. 



\ 



•<• 



D. Spicule Are»« of Endwavor ; 

1. Clinical Evaluation - All patient* who receive whole body radiation for 
ajuf purpoies ihould be evaloated carcfxilly utUislng all clinical and laboratory 
ebaervatiooa which can be rcaeonably obtained. Clinical patterns related to done, 
coezieting diseaee, nutrition and other parameter* may thus be identified. 

It would teem important to carry these obaervationi farther at various dose 
levels as most planning for capabilities of humans after exposure depend on a 
knowledge of their expected performance. 

2. Metabolic Effect* • Coctiauinf metabolic studies are needed. Little 
Is k&own of nutritional requirements and fluid and electrolyte changes in humans. 
Some inveatigatort state that these aspects are not important in radiation injury 
on the basis of animal studies. There has not been enough human research in 
this area to provide convincing data at any dose levcL Such information is 
e**ential in planning patient care. 

Change* in DNA>RNA aystems in so contplex a mammal as man may b* 
difficult to find. Some preliminary obacrvatioas in our laboratory indicate that 
further studies is this general area may be fruitful. M&r.y other oysteras might 
be suggested as shown by the observation* of Cerber et al (11) regarding creatin- 
aria, beta amlnoisobutyric acid and hydroxy proline. The use of labeled prscursors 
is suggested since at some time it will be necessary to determine whether certain 
change* following irradiation arc due to specific biochemical alterations or are 
due to nonspecific stress. > 

Changes in the immune syctem have to date eluded most observers who 
have sought them. With the renewed interest in immunology centering botn about 
tho lymphocyte and thymus, new techniques of study shoold be sought. 

3. F.tliavioral Effects - One of the questions mopt frequently asked by 
Individaals responsilile lor placsisg for nuclear warfare concern* the effect 

of a given dose of radiation on subsequent capability and performance of an 
individual or group. It is apparently not easy to find a suitable test or battery of 
teste which measar* the important human functioiis of performance or decision 
mahin; such that one or more tests could be used before and after exposure to 
radiation. 

Appropriate performance tests should be developed or adapted. These 
test* should be q;iven to subjects before and after exposure to ascertain changes In 
the capability of the individual. 

4. Dose Restionso S^l'■!ie^ • I/io*t studies have been carried out wiU» rati* 
such th-^t tae cose ie delivered vithin 30-300 minutes. If a dose of ZOO tti^ is 
delivered in approximately 90 minutes and produce* a given effect it become* 



361 



•5- 



faaporUEt to datarmla* th« change 1& cffacta U tMs doae U gWen in 0. S - 5 nlnnUt. 
Thcr* Is much tpaculAtlon aboist tM* problem «t a human Uvel based on animal 
■tudlca but no predee data ha* been obtained in humane. Similarly the eUcet ol 
lew doee rate* should be studied particularly in relation to performance t«stlnj|T 
The eiiecU of high doae* (ICO - ^00 rad) followed by daily dose* to test the 
concepts of ecjuivalent residual dose (12) would be of importance, fractionation 
studies should be continued. 

5. Partial Body Studies - Patients in whom -vmiiou* parts of the body 
have been shielded would be compared to patient* who have rccciTed whole body 
radiation using a variety of indies*. 

6. Prognosis - The vast amount of data which could b« generated by the 
■tudie* de*cribcd herein should b« collected, tabulated and prepared for computer 
analysis so as to make theee data easily available for physicians, commanders et al. 
This function might well be assigned to the office of the Surzeon of CASA or other 
representatives of the respective Surgeon* Cenaral to insure preaentation of the 
diatn in it* moat uaeiul form. 

7. Therapeutic Uethoda • In view of the hasarda involved in thia form of 
therapy, betore increasing tna dose beyond 200 rad all measure* to protect the 
patient must b« available and ready for inunediate use. The patient should be ir. 

a clean area «-ith an aseptic treatment room available. Autologous marrow should 
b« stored and ready for reinfusion before therapy. Optimum time for reini'usion 
will have to be determined. 

In general on* might consider studying antiradlatlon druf{s in faazxians. 
In spit* of the great volume of ar.lmal work in this area, most dru;:s have varloss 
drawback* for human u«e. One *uch drawcack i* that it is not possible to do dru^ 
teetin; at an Ll'tio ^*v<^l ^ htunan*. V/ith the development of aUtiitional biological 
indicator*, however, such drag* might be *tudied at lower doae levels. 

8. D."e of Healthy Volunteor* - Once patient* from the therapy group ar* 
being manai^ed so tbat their hftTnatoloRic conaequcncea of radiation have been 
controlled then it will be adviaable to utilise a leae ill, more normal group of 
iadlvlduale for *tady. 

Con*lderation should b* given to the u** of volunteer* because of the 
peeaible bia*e* introduced, and perhap* unreco^rUsed, in patients receivic;; 
therapeutic ra^iaUoiu Six&ilarly ia accident victim* complete pre ezpoaure data 
i* u*ually not available. 

E. rUTPRE PLAK3 PEOARDPJG FUNDING ; The •tudie* described above will 
require t:»9 p^rtici^aUon of a :.ur.-io«r oi research centers a:.d t:ie aevolopmect of 
at leaet a limited number of special facilities such a* radiation units eapaole of 
vtty high and very low doe* rate* and appropriate clean and aseptic room* aa 



362 



w«U &« othAr Uberatory facUiUts. 

It DIM *it»vax9» that the ratio o( foada for all huxnaa radlatioa rassarch 
!■ about 5% ei ta« total fUxUag of biomedical rctaarch ona might also asaome 
that precant 'tijh doao" or acuta ctuciiea repraaaat bo mora thaa 0. 5 • 1% of 
thla total budget. 

Tbarafora, a thraa to focrfold iacraaas la raaeareh fuada in th« above areas 
ts rccommeiuled for the asxt three to live years. AXter that time the total fnads 
should agaia be doubled. -jj'^-:, 

M such a tima as there is no threat oi thermomclaar war, these programs 
could be greatly reduced or evea eUmiaated. 



363 



-7- 

RgrERENCES 

1. Aadarsoa. D. R. Exp«riia«Btal Tr*&tm«st of RartUtloa Injury ia Meakayt. . . 
1b DUgaetis aad Tr*«tm«nt el Ac«t« Radi&tlon Injury p. 363 World Health 
OrgABlEatloa, 1961. 

I. HeUcreft, 3. W. and Matthaw*. M. EiXact of loalaing Irradtotion TrMlmcata en 
T«nor &«gr«aslon. J. Nat. Canear Inat. 14: 527-$3$, 19S3. 

3. Htnylmann. L. H. , Llace. H. and Hoffman, 3. G. Tha Acnta Radiation 
Syndroma. Ann. Int. Kad. 36: 279-310, 1952. 

4. Andrews, C A. , Slttaraon. B. W., Kratcfamar, A. 1>. , and Brocar, M. 
CritlcaUty Accident at tha T-12 Plant In IHagnesU and Traatmant of Acnta 
BadUtlon Injury. 27-48. WHO Naw York 1961. 

5. Shlpnaan, T. L. A Radiation Fatality Resulting rron Idaashra Ovarazposure to 
Naatrons and Ganuna Rays. Ibid p. 113-133. 

4. Rowland, J. W. , Ingram, M. , Marmagan, H. and Hansen, C. L. Tha Lockport 
Incident: Accidental Partial Body Exposure of Hunoans to Large Doses of X- 
Irradiation, ibid p. 11-26. 

7. Thoma. C. E. . Jr. , and Wald, N. The Diagnosis and Management of Accidental 
Radiation Injury. J. Occup. Med. 1:421-447. 19S9. 

8. Collins, V. P. Therapeutic Use of Single Dosee of Total Body Radiation. 
Am. J. Foeatg.. Rad. Therap. V Nuc. Med. 75: 542, 1956. 

9. King, E. R. Use of Total Body Radiation in tiia Treatment of Far-adranced 
MaUgnaneies. J. A.M. A. 177:610-613, 1961. 

10. Mullcr, L. S. , Fletcher, O. B. , and Cerstner, H. B. Systemic and Clinical 
Effects Induced in 263 Cancer Patients hy Vv hole-Body X-irradlatlon with Nominal 
Doses of 15-200r. Report 57-92 School of Aviation Msdicina, Randolph AFB, 
Tens 1957. 

II. Cerber, G. H. Ccrtler, P., Altman, K. L, and Hempelmaaa, L. H. Deso 
Dependency of Radiation Indncad Creatine. 

12. Exposure to Radiation. Report No. 29. National Committee on RadiatioD 
Protection and Measurements. Univ. Chicago 1962. 



364 



April 2, 19.94 
To Whom It May Concern: 

My name is Josef Jerome Kahr. I am one of five great nephews of 
the late Margaret Bacon. She was partially responsible for my 
upbringing. She was also an intricle' part of my life for 13 
wonderful years. She shared a residence with myself and her sister, 
Lillian Joan Kahr, who was my grandmother and my legal guardian. 

The death of my great aunt was a very hard matter for me to accept. 
The heartfelt joys that we shared turned into faded memories. All 
the happy times we spent together turned into heartaches and sorrow. 
Her death felt like a lethal weapon that wounded my soul and left 
an emptiness that will never go away. 

The thought of my great aunt suffering through needless and un- 
authorized radiation treatments is totally repugnant. Nothing 
will ever bring my great aunt back, but I feel something should 
be done, to those parties that are responsible for doing radiation 
experiments on her without her consent. 

It is unthinkable that a hospital misused and prematurely ended 
the life of my great aunt, Margaret Bacon. 

The hospital had no right to play God; 

Sincerely, 



JoseTB Jerome-J<ahr 




365 

April 8,1994 
TO Whom IT May Concern: 

My Name is Margaret J. Willis. I am the great niece of the 
late Margaret Bacon. She was a very inportant part of my life 
and upbringing. She also had a hand in the upbringing of my 
late mother Ella Margaret Willis. In her latter years she 
she shared a residence with her sister, Lillian Joan Kahr, 
my grandmother. 

When my Aunt Margaret became ill my mother, grandmother, and 
other members of the family had to talk her into going into 
the hospital. That is when I found out she had cancer. MY 
mother, grandmother and myself went to the hospital to visit 
Aunt Bacon ,and I wondered why she was laying with blood over 
her sheet. 

I think this may of had something to do with why my mother 
refused treatment of cancer. due to the death of her aunt. 
Just the thought of my great aunt suffering through needless 
and unauthorized radiation treatments is totally repugnant. 
Nothing will ever bring back my Aunt Margaret, I do feel some- 
thing should be done to those parties responsible for the 
radiation experiments with out consent. 

This in it self makes you very leary of going to a hospital 
that would let this gg on. 



Sincer^lXf « 

Ms. Margaret J. Willis 



366 



April 4, 1994 



AMELIA JACXSOM 
PATZ8MT KO - C7 



On October 21, 1966, after being discharged for General Hospital, 
Ms Jackson iiras a very weak ill vonan. she was unable to take 
care of herself properly, and depended on the family for all her 
basic needs. She expexlenced bleeding from her rectum, loss of 
appetite, naiisea, vomiting, weight loss, and was in constant 
pain. Her condition ntiver improved. 

Within a few weeks she was readmitted to General Hospital. The 
family was informed sh<» should be transferred to Drake Hospital. 
Ms Jackson indicated she was afraid and wanted to return home. 
She was transported houe, where she was loved and cared for by us 
until she died on Kardi 25, 1967. 

The family of Amelia J.ickson would like for this committee to 
know, that for the entire 163 days after receiving the 
irradiation, her condition continued to deteriorate. We feel 
that the 100 rads of partial-body irradiation administered to her 
was cruel and didn't help her condition in any way. it's our 
belief that she may have lived longer if this experiment had not 
taken place. 

A doctor is someone you trust. His job is to do everything in his 
power to alleviate your pain and suffering. However, this was not 
the case. She was always crying, moaning, groaning, and in 
excruciating pain. Ms Jackson was used to further Dr. Saeger's 
professional goals. It was purely an ambitious and callous act. 
Neither Ms Jackson noj- the family were informed or consented to 
her being used in an <ixperiment conducted by Dr. Saeger, and 
funded by the Departmont of Defense. There has clearly been a 
cover up by means of liie Government, General Hospital, Dr. Saeger 
and City of Cincinnati. We cannot believe that they consented to 
such atrocities to be financed by the government; utilizing Ms 
Jackson's and the family's tax paying dollars. 






367 



My Aunt Louise Richmond passed away from Colon Cancer in March, 1 968. She 
was only 49 years of age. My Mother Viola Macklin (one of Louise's older sister) 
brought her from Cleveland, Ohio to Cincinnati, Ohio for medical care of her cancer at 
the General Hospital. 

Instead of medical treatment, my Aunt Louise, unknowingly was used as an 
experimental subject at General Hospital in their radiation experiment. Within weeks of 
her admission, her health rapidly and painfully deteriorated and ultimately leading to her 
death. 

Regrettably, the news of the General Hospital Radiation experiment has recalled 
many agonizing memories for myself and my family. The death of a loved one, under 
normal circumstances is difficult, but now with the added knowledge of my Aunt 
sacrificial involvement in the radiation experiment, my family members must relive the 
misery, now with twice the anguish. 

Various family members can vividly recall the evening visits to the hospital as we 
accompanied our mother to visit Aunt Louise. The torturing cries of pain that greeted us 
as we entered into the hospital ward had become all to familiar to us. She would be 
lying in her hospital bed trembling and shaking from her agonizing pain so forcefully 
that the bed itself would be visibly vibrating. 

Throughout the visit, my Aunt Louise would cling on to my mother's arm crying 
and begging her to take her home. She would repeatedly say, "please Viola take me 
home with you, l['m in so much pain, they are hurting me, they are trying to kill me". 

The visits would always end with my mother tearing herself away from my Aunt 
Louise only to hear her cry in pleading desperation as we walked away. For seemly, 
hours after we left the hospital and even after reaching home my mother would cry from 
the guilt she felt for my Aunt's severe pain and suffering. My mother would routinely 
rock herself to sleep while crying and humming spiritual songs to relieve the 
burdensome feeling of her most recent experience/visit to my Aunt Louise. 

After my Aunt Louise' death in March, 1968, my mother would often ask us if 
they (the Doctors at General Hospital) were really giving her the correct treatments for 
cancer. 

We had no idea Aunt Louise was a part of a Defense Department experiment. 
We're sure if she had known she was a guinea pig, she would not have participated. 

My mother would often recall the visit and continued to blame herself for the 
pain and anguish my Aunt Louise had experienced. My mother carried this unwarranted 
guilt to her death, and now we have been forced to carry this guilt as well in memory of 
my mother and aunt. 






368 



Date: April 4. 1994 

To: Robert B. Newman, Attorney at Law 

From: Members of the Maude Jacobs Family 

Subject: Radiation Testing at UC (Cincinnati General Hospital) 

This correspondence is regarding Maude Jacobs, a female Caucasian, 
who was an unsuspecting victim of the radiation tests conducted by 
the University of Cincinnati. Maude was born in Whitesburg, 
Kentucky on June 7, 1916. The third grade was her final year of 
formal education. By the tim.e she was thirteen years old, she was 
married and had given birth to her first child. She bore seven 
children in all, six girls and one son. She was a beautiful woman 
with a lovely radiant smile. She was impeccable about her 
children's appearance, as well as her own. Her devotion to her 
family was obvious to anyone who knew her. Maude lived her life 
below the poverty level, but was a proud and dignified woman. She 
was genuinely happy with the simple things in life. Her delight 
was cooking and caring for her children. When she died she was a 
widow and left three minor children at home. 

According to information from CGH (Cincinnati General Hospital), 
Maude was diagnosed with breast cancer on July 17, 1964. A 
treatment of hexamethylmelamine began on July 27,1964 and was 
completed on August 18, 1964. With this medication her primary 
tumor receded markedly. On November 7, 1964 total body irradiation 
was administered. The midline absorbed tissue dose was 150 rad (250 
r midline air dose). At the termination of the treatment she had 
severe vomiting for twenty-four hours, in spite of intramuscular 
compazine. Before treatment she had a normal hemogram. Seven days 
after treatment the white blood count began to fall. The platelet 
count fell around fourteen days after treatment. The WBC was 1,000 
and platelet count was 80,000 twenty-three days after treatment. On 
the twenty-fourth day, the WBC was 850 and platelet count was 
38,000. Maude died December 2, 1964. Twenty-five days after total 
body irradiation. She was study number 045. (Documentation from CGH 
attached. ) 

Two letters written by Maude to her sister Arlie less than two 
months before her death describes how she felt, and also indicates 
she thought the doctors did not know what was wrong with her. She 
talks of living near her oldest daughter, Lillian, who is very 
helpful to Maude. She also is pleased to be home with her children, 
but feels sorry because she is too tired in the evenings after 
preparing dinner to watch television with them. She refers to the 
expense of her medication and said prayer helps her more than the 
doctors. These letters demonstrate her education level, but also 
reveal her devotion to her children. Maude had no knowledge of the 
seriousness of her cancer much less knowledge of the radiation 



369 



treatment. She did not expect to die. If she had, she would have 
discussed the future care of her minor daughters with the rest of 
the family. Her death was so sudden and unexpected the family was 
totally unprepared. The three young daughters eventually were put 
in St. Aloysius Orphanage. (The two letters from Maude to her 
sister are attached.) 

The family was NEVER informed of the radiation test or it's 
purpose. Nor was anyone ever asked to sign a consent form or give 
verbal permission for testing. Some of the memories which were 
dismissed without attaching importance now make sense or at least 
raise suspicion. Her daughter Irene was seven months pregnant at 
the time and was having a difficult pregnancy. She remembers 
Maude's bright smile and cheerfulness, then remembers a private 
room and no more smiles or happy faces. Irene remembers being 
afraid of going into that room. Maude asked her to feel her head 
and when she did it felt full of soft tumors. Her body felt like 
sand. Even in the hallway she could hear Maude's delirious talk. 

Maude's daughter Sherry was twelve years old and remembers the 
private room, but at the time didn't know it was uncommon for a 
person without insurance. Sherry remembers the orphanage and being 
split up from her two younger sisters. The youngest girl, Kim, 
eventually went to a foster family. 

Robert Murphy, one of Maude's grandson's, remembers thinking how 
nice it was to have a private room without insurance. Bill Murphy, 
another grandson recalls visiting her in the private room, but not 
wondering why she was there. He remembers her conversation as "out 
of her head". 

Her oldest daughter, Lillian Murphy Pagano, lived downstairs from 
Maude and was her primary care provider. Lillian was never 
contacted or consulted about her mother's treatment. She remembers 
a drastic mood change associated with rapid physical deterioration. 
She too recalls the private room at the end. She remembers thinking 
her body felt like sand. She was concerned too for Irene, because 
of her pregnancy and the worsening of their mother's health so 
rapidly. Lillian's concern grew as Maude quickly became disoriented 
and no longer recognized anyone. She was violently ill and talking 
utter nonsense. Maude died before her time everyone felt. Her 
family lived for the next twenty-nine plus years with the sadness 
of her death, but also had warm memories to console them. 

Since the details of the experiments became public, the entire 
family has been drastically affected. Now guilt has replaced the 
sadness and comments like "I should have known" or "I should have 
asked" are commonplace. Reliving Maude's last days over and over, 
remembering differently now why she was so violently ill, how she 
suffered, and now a reason for the private room. Her death is now 
a nightmare. She died without comfort and dignity. She was 
discriminated against and selected because of her background. No 
benefit was ever planned for Maude. She was a number," a statistic. 



370 



Her children want an apology. They want to know nothing they could 
have done would have altered the results. They want Maude to know 
they are sorry if they disappointed her because she suffered 
needlessly without intervention from them. They also need a quick 
resolution so this too can be a memory. Already too much damage has 
been realized. 

Lillian Murphy Pagano (Maude's oldest daughter) feels personally 
responsible for her death. She became obsessed with Maude's death, 
often calling other family members several times a day to go over 
some part of her last days again and again. She was found several 
times at three or four o'clock in the morning with a fixed stare 
and silent sobs. Eventually she was rushed to the hospital with a 
suspected heart attack. After a short stay of a few days, some 
testing, several prescriptions, and instructions to avoid stressful 
situations, she was permitted tp go home. Anxiety struck again 
within a few weeks. This time she was gone. Lillian's daughter 
found her, called 911, and received over the phone guidance for 
delivering CPR . When paramedics arrived, she was given multiple 
shock treatments to revive her. It is estimated she was dead for 
four minutes. She was on a respirator and in a coma; she also had 
several seizures. The doctor's gave her a 50% chance of pulling 
through, but warned all about the possibility of permanent brain 
damage. She has regained consciousness, but is still in critical 
condition at this writing. She recognizes family members, but is 
mentally unstable. The extent of damage is still unknown. Her 
family has been told she will need twenty- four care and cannot be 
exposed to ANY stressful situations. She doesn't talk about Maude 
now. She doesn't even remember who visited her an hour ago. 

The ordeal with the UC experiments must come to a swift conclusion. 
This is the saga of only one family, there is supposed to be 
eighty-seven more victims with families. It's amazing how something 
that was a remote, barely thought of memory, now is resurrected and 
grown into an unwelcome demanding problem. A problem that can 
consume your days and affect people from twenty-nine years of 
family growth people Maude never could have known. 

This letter was compiled from the hearts and thoughts of Maude 

Jacob's children: 

Lillian Murphy Pagano (nee Phillips) 

Irene Froman (nee Phillips) 

Bob Phillips 

Betty Wolfe (nee Phillips) 

Sherry Brabant (nee Jacobs) 

Janet Baker (nee Jacobs) 

Kim Swedo ( nee Jacobs) 



Attachments 



371 



March 31. 1994 



To Whom It May Concern: 






My name is Joe P. Larkins. I am now 52 years old. My Father, 
Willard L. Larkins, passed away in 1971. I was 30 years old 
at the time. My family consisted of myself, an older sister 
and my parents. When my Father passed away, he and my Mother 
were in the process of raising a grandchild (my sister's 
son). Neither of my patents were well-educated, but my 
Father was hard-working and honest. We always had clean and 
decent clothes to go to school in and we always had ample 
food on the table. It doesn't take a well-educated person to 
be hard-working or honest. If Cincinnati General Hospital 
and the Doctor's therein had been honest, there is of 
course, the possibility that my Father could have lived for 
several more years. Instead, he went from a fairly 
able-bodied middle-aged Father and Husband to a premature 
death caused by an "experiment" . My Father did not know that 
he was being used as a guinea pig; my Mother did not know; 
as his children, we were not informed of the procedures to 
be used nor of the risks involved. 



I feel as though Dr . Saenger and the other 
"Doctors" involved, if you will, knew that the high levels of 
radiation which they administered to these patients had the 
very real probability of being fatal. Oh, how right that is! 
My Father was very much a family man, yet these people 
killed him as surely as if they had put a gun to his head 
and pulled the proverbial trigger. These "Doctors" left my 
Mother, with no job skills, to raise a grandchild as best as 
she could. My Mother lived until 1983, but she was a broken 
woman after my Father's premature and unexpected death. 



I know that my Father knew that something was very wrong 
with the treatments being given to him at Cincinnati 
General. He even asked me "Son, what are they doing to me? 
They're trying to kill me!" That's how bad the pain he 
endured after the treatment was. He suffered so needlessly. 
What really gets me about this situation is the fact that 
the Pentagon contracted with these Doctors and this hospital 
to test the effects of radiation on the human body. Everyone 
realizes that Cincinnati General Hospital, now the 
University of Cincinnati Hospital, treated many 
low-education, low- income patients. I guess they felt that 
in some way, the fact that these patients were not rich, 
upper-class citizens, gave them the right to experiment with 



372 



their bodies without informed consent. NOT SO! I feel sure 
these physician/researchers were well-paid for their part 
and it would be very interesting to know the types and 
dollar amounts of the grants given to Cincinnati General by 
the Federal government. I feel sure that all parties, with 
the exception of the poor, unsuspecting patients and their 
families, were well-compensated. But since when, in our 
society, does one man or even a group of them, have the 
right to play God? A very good example of this is our 20th 
century "assisted suicide Doctor". This man is contacted by 
terminally-ill patients who wish to end their own lives with 
dignity and choose, by their own voilition, not to suffer 
needlessly for years. These people make the decision to die 
in peace, yet our great judicial system, along with the 
medical community, brought this compassionate physician up 
on charges. The differences in these deaths and the death of 
my Father are that my Father did not choose to die - someone 
else made that decision for him, without consulting or 
informing him and they were amply compensated for it. I feel 
that the price they should be required to pay to the 
families of the people they killed, should be exceedingly 
high. I also feel that the Federal government should be 
named as a. co-conspirator in this case, because that's 
exactly what it was - a conspiracy. No person, and I 
emphsize 'NO', person would willingly consent to a treatment 
with any degree of fatality involved. People, both you and 
I, simply value life too much. I think that is the big thing 
here - the patients were not informed. I know that behavior 
of this sort would not be tolerated by the medical community 
today. But then again, this entire mess was surrounded by a 
thick veil of secrecy on both the doctors' part and on the 
part of Cincinnati General Hospital. It is still being 
closely guarded and kept under yet another veil of secrecy 
to this very day by the University of Cincinnati, in that 
they have yet to provide the medical records of the patients 
involved in this experiment/ I beseige you to order the 
University of Cincinnati to release the patient records, in 
their entirety, to the next of kin immediately. They are 
hedging to save their own skin. I was promised my Father's 
complete medical file over a month ago; as of this writing, 
I have nothing. 



I only hope that you, the Congressional Committee, see fit, 
as members of the human race, to break this matter wide open 
here and now and award just compensation to the families of 
the victims. I feel that the Physicians involved and also 
the federal government (the Pentagon) should pay and also I 
beg you to strip any and all of the Doctors involved of all 
their medical credentials that they hold. If justice 
prevails in this matter, and I have faith that it will, a 
strong message will be sent to our government officials and 
the private physicians (to whom people entrust their lives 
and the lives of their loved ones) that behavior of this 



373 



sort will simple/ not be tolerated, that justice will in 
fact be both swift and severe. I pray that a situation such 
as this will never again be faced by a group of people. If 
this statement to you, the Congressional Committee, does 
anything to help in the name of Justice, then my Father's 
death and the sorrow and hardships that his familty faced, 
will not have been completely in vain. 

Thank you. 



374 



TO: Chairperson of the Congressional Committee 

RE: The Partial and Whole Body Radiation 
Experiment Conducted from 1960-1971 

FROM: Mr. Woody Plair and Family of Mrs. Beatrice Plair 

This letter was very difficult to write for us, the family 
of our departed wife, mother and grandmother. We conversed of 
many traumatic thoughts and feelings regarding our loss. 

Herein is the summation of our collective thoughts and 
feelings. Dr. Saenger states that the patients and families gave 
their consent to receive partial or whole body radiation. For 
the record, our mother loved life and she would have never given 
her consent to any treatment that would have shortened her life 
or cause her the pain, we observed. She never knew she was part 
of the Cold War Radiation Experiment. As a family, we were never 
told of her participation in partial or whole radiation. We 
would have not given our consent for her participation in an 
experiment . At no point in the supposed treatments of our mother 
did anyone tell our father nor her children that she was part of 
a dangerous and life threatening experiment. 

What we can say to the Sub- committee is that we remember our 
mother complaining of increased pain, especially following the 
radiation exposures. We can told you how our mother told us she 
felt as though she was on "fire" or "burning all over". We can 
tell this committee, we resent our mother being used as a human 
Guinea Pig and the implication by Dr. Saenger that our mother 
agreed to have her body exposed to radiation injury that would 
lead to serious pain and shortening of her life. 



375 



The Plair family asked this Sub- committee to help us to 
bring the people who we feel shortened our mother's life to 
justice. 

In a society where life, especially human life appears to be 
worth less and less, we and other families are depending on this 
Sub-committee to send a clear message to Dr. Saenger and 
associates, the University of Cincinnati Medical Center and the 
Defense Department that human life is still important. 

We must let the world know that here in America, what makes 
us different and greater than other countries is that we truly 
value each and every human being regardless of their I.Q., 
education, race, creed, color or position in our society. If we 
allow this travesty of justice to go unchallenged others may be 
unknowingly experimented upon in the future . 

Respectfully submitted, 

Mr. Woody Plair and Family 



376 



To Someone Who Will Listen: 

I was 30 years old when my mother was stricken with cancer. 
She had six other children, three very young at home, the oldest 
was 12. She was bom (my mother) in Whitesburg, KY, 1916, only 
went to the Second Grade of Grade School, was married at 13 years 
of age. When cancer struck she had no money. Her husband had 
only been dead a short time and she was struggling to care for 
her three girls at home. She wanted to spend as much time as she 
had left enjoying her three daughters. She was being treated as 
an out-patient at General Hospital. One day near the end nurse 
called told her to come to hospital clinic. She took a taxi 
because no one was available to drive her. She came home weak 
and vomiting. She was admitted to hospital and only lasted less 
than a month. When we (the family) found out recently about the 
150 Rad she had received my older sister felt she was to blame 
because she did not go with her in taxi to clinic. She had to be 
hospitalized herself and may need constant care. A younger 
sister has M.S. and has not been told for fear she won't be able 
to cope with it. I'm sure all the other families that are still 
alive are having similar problems. My prayers are with them too. 
As you can tell from my letter, I don't have a good education. 
Should I be afraid to be treated in a hospital? Afraid of being 
used for testing some other chemical to benefit our government. 
Or carry a Donor's Card so if they wanted an organ they could 
take it at will? Something needs to be done it is up to you. 
I'm helpless. 

Thank you. 

Bob Phillips 

Son of Maud Jacobs #4 5 



377 



TO : Congressional Committee 
FROM: Herbert F. Varin 
DATE: April 4,1994 



Study #075 N.C. 
Chart #CGH 409-278 

My mothers name was Nina L. Cline, a loving and caring mother, 
whose only hope was to see her grandchild before she died. She did 
10 months before her death. She was also very close to her sister, 
and her sisters children, who were all v^ hdpfiil with my mother 
during her cancer. 

My mother was diagnosed with cancer in 1962, she put a lot 
of hope and faith in her doctors and General Hospital who were treating 
her. She often talked to me and other family members about her 

treatment, but at no time did she mention being apart of any experiments 
for the government. She would have talked to me and other family members 
before ever consenting to any experiments. 

I am appalled to think that Dr. Eugene Saenger, his associates and 
our Federal Government would join is such an inhumane act. I also 
believe Dr. Eugene Saenger violated his moral and ethical obligation 
toward his patients. 

We were taught as children and young adult, to believe in our 
Federal Government, that they would make all the right decisions 
concerning our welfare as people. For the government to sponsor a 
radiation experiment of this nature, on my mother and other patients 
was totally immoral. 



Herbert F. Varin (Son) 



;;^4/^y--//^ 



378 



RADIATION EXPERIMENTS 

TO WHOM IT MAY CONCERN! 

MY NAME IS JOE KAHR SR. ,MRS MARGARET 
BACON WAS MY MOTHERS SISTER, WHICH IS MY AUNT. 
I ALSO, LIKE MANY OF OUR RELATIVES WAS PARTLY RAISED BY MY 
AUNT MARGARET BACON OF WHOM I HAVE VERY FOND MEMORIES OF. 

IWAS ENCOURAGED BY HER HOSPITAL DOCTOR TO CONVINCE HER 
(SINCE SHE DID NOT WANT TO ENTER A HOSPITAL ANYWAY )THAT 
GENERAL HOSPITAL (THE HOSPITAL SHE WAS IN AT THAT TIME), HAD 
THE BEST RADIATION FACILITIES IN THE CITY WHICH COULD HELP 
HER SITUATION IMMENSELY. 
AFTER A WHILE, SHE AS WELL AS I BOTH BELIEVED THE DOCTOR . 

IF YOU KNEW THIS FAMILY, THEN YOU WOULD KNOW THAT WE ARE 

THE LAST OF ANY INDIVIDUALS TO COMPLAIN. 

HOWEVER WHEN IT REACHES THIS POINT, THEN WE CAN NO LONGER 

REMAIN THE SILENT INDIVIDUALS THAT WE ARE. 

SHE NEVER ASKED FOR MUCH, NOR DID IT TAKE MUCH TO SATISFY 

HER. 

HOWEVER, BEING A HUMAN RADIATION GUINEA PIG IN THIS TYPE OF 

DEATHLY SITUATION IS DESPICABLE , WHEN ONE SUCH AS HER LOVED 

LIFE AS SHE DID. 

THE FIRST THING MY AUNT AND I NOTICED AS WE ENTERED THE 
CINCINNATI GENERAL HOSPITAL, WAS THE AMAZING UNIVERSALISM 
WHICH WAS EXPRESSED IN SUCH PROFOUND ELOQUENT AND EQUIVALENT 
LANGUAGE, THE DIGNITY AND WORTH OF ALL PATIENTS, WHICH THEN 
WAS MENTIONED THAT ALL PATIENTS WERE TREATED EQUALLY. 
ON ONE HAND, IT WAS PROFESSED TO US, THE NOBLE PRINCIPALS AND 
EXPECTATIONS OF THE HOSPITAL. BUT IT SEEMS THAT ON THE OTHER 
HAND THAT SOMEONE WAS SADLY PRACTICING THE VERY OPPOSITE OF 
THOES EXPECTATIONS THAT WE WERE ORIENTATED WITH. 

lAM SURE THAT SHE AS WELL AS OTHERS WANTED TO BE CONTENT BUT 

IT SEEMS THAT SHE WAS USED AS AN EXPERIMENTAL OBJECT AND 

BECAME THE VETERAN OF CREATED SUFFERING. 

I NEVER DREAMED THAT THIS FAMILY WOULD EVER BE EXPOSED OR 

WRONGED BY SUCH AN IMMORAL AND UNJUST SITUATION. 

I FEEL THAT I MUST SPEAK NOW BEFORE IT IS TAKEN FOR GRANTED 

THAT WE ARE STILL ONE BIG HAPPY FAMILY, NOW OPPOSED TO WHAT 

WE USE TO BE. 

IT SEEMS THAT THIS NOW IS THE KIND OF ENVIROMENT IN WHICH WE 

LIVE. HOW CAN WE AVOID BEING DEPRESSED WHEN WE DISCOVER 

THAT ALL PRIOR GENUINE CODE OF ETHICS ARE SLOWLY CHANGING 

FOR THE WORST. 

WE ALL AS LOVED ONES ARE INVOLVED IN A NETWORK OF 

MUTUALITY, TIED IN A SINGLE PROMINENCE OF OESTINEY. WHAT EVER 

EFFECTS ONE FAMILY DIRECTLY, EFFECTS ALL FAMILIES 

INDIRECTLY. 

WE CAN ONLY AND WILL ONLY SURVIVE THIS EMOTIONAL 



379 



CATASTROPHE, BECAUSE IF SEEMS THAT WE HAVE NO ALTERNATIVE IF 
WE WISH TO KEEP OUR SANITY. >.■.?-.# 

■ ', ■ .' ' ' '■■ •'■<■ 

IT IS A TORTUROUS LOGIC TO USE THE TRAGIC RESULTS OF THE' ^ ' 
HOSPITAL OR GOVERNMENTS REASONING AS AN ARGUMENT FOR THE 
CONTINUATION OF RADIATION EXPERIMENTS DURING THAT TIME. /. 

WE SHOULD HOPE THAT NEVER AGAIN SHOULD WE OR ANYONE ELSE •- 
HAVE TO RESIGN OURSELVES TO SUCH AN OUTRAGE. ' • " 



THE TORMENTED AND UNHAPPY FAMILY OF MRS MARGARET BACON, 



380 



April 8, 1994 



To Whom It May Concern: 

It Is our feeling that our mother was not informed of the true 
nature of the radiation she received at Cincinnati General 
Hospital. It was her belief and ours that the radiation "therapy" 
was being performed to ( 1 ) reduce the pain due to her cancer and 
(2) to kill tumor cells in order to possibly extend her life 
expectancy. This is what we were led to believe by the physicians 
and other health professionals in charge of our mother's care. We 
all were led to believe that the radiation therapy would also 
benefit mankind in determining the efficacy of these treatments, to 
help cancer patients in the future. 

As a family, one small consolation in watching our mother die a 
slow and painful death from cancer was the fact that her 
participation in the treatments would represent a positive outcome 
from her death in the form of her helping others who shared her 
fate. 

Having found out the truth about what really happened to our mother 
has not only brought back painful memories of seeing her suffering, 
we must now live with the knowledge that this suffering 
(excruciating physical pain, intense fear, despair, and many other 
terrible effects of the treatments) was intensified and not 
alleviated by these radiation experiments. This has caused even 
greater pain and suffering knowing that our mother was treated no 
better than a laboratory animal thereby robbing her of her human 
dignity and the right to live out her final days as comfortably as 
possible. We believe her life was shortened immeasurably by these 
physicians making god-like choices which they had no right to make. 

Sincerely, 





Elyse A. Feltrup 

Daughter of Rose E. Strohm 






Stephen G. Strohm 

Son of Rose E. Strohm Date 



381 



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382 

March 29, 1994 

TO THE CONGRESSIONAL COMMITTEE OF MR. DAVID MANN: 

I, Doris Baker, only have a few things to say. One is why were we kept in the 
dark about my great grandmother and the other is why didn't they tell her about it? Her 
life, was her's and God's, not their's. 

I had to take care of her as a young pregnant 1 7 year old mother day and night. 
They said she didn't return, she couldn't even walk by herself. I had to lift her to the 
bathroom. I watched her slowly die. She tried to fight it; even when they told her she 
was dying. At times, she was in so much pain, i would ask her what was wrong and 
she would say nothing, but I saw the tears in her eyes and the pain. 

You know, I almost lost my baby, because I was tired and run down from taking 
care of my grandmother. My child was born on 10/20/64 and only weighed 2 pounds. 
Please someone tell me why? 

That lady was my life, for personal reasons. After 30 years is still hurts, because 
she was my protector. So you see she never would have agreed to be a guinea pig for 
no one, because she loved life. When you shortened her life, you caused my brother 
and I alot of pain until this day. So please someone be honest with my family and I. 
Because no one was honest with Mrs. Gertrude Newell. She was just a case number 
and a piece of meat to them to experiment on for their use. 

Sincerely, 



Doris J. Baker 



383 



#055 


Lillie 


Wright 


Chart 


No. 


44174 



My mother Lillie Wright was admitted to Cincinnati 
General Hospital Aug 23, 1965. She was sent there for a 
biospy. She was confined to the hospital for one 1 week. 

The summary I recieved of her illness revealed that 
her biospy was performed. Aug 30, 1965 diagnosis was 
Carcinoma of the breast. On September she was given partial 
body irrodation 200 rad midline. On October 8, 1965 local 
x-ray therapy began. In 53 days she( Lillie Wright) had 
recieved 2000 rads to her left and right chest. 

On December 1, 1965 x-ray was begun on the 
imtermammary chain and to the anterior and posterior above 
the collarbone region (supraclavicular). She received 4000 
in 40 days. Her white blood cell count fell to a low of 
2200 on December 3, 1965. These doses of radiation in 
my opinion was enough to destroy bone marrow and white 
blood cells and even the patient. 

We the family of Lillie Wright was not notified about 
these radiation treatments or any other procedures which 
may have taken place. We did not sign any papers to permit 
this experiment to be done on her( Lillie Wright). 




1^^'^ /y^..e,..C PL 



384 



The doctor at the hospital gave her sample tubes of 
oniment to use on her breasts, her back and abdomen. 
Her skin was burned on both breast. Her back and abdomen. 
There was raw flesh exposed where once there were skin. 

I had to apply this oniment to those exposed areas. When 
I applied this oniment to those raw areas she was in such 
excruciating pain I cried. She was given enough oniment 
for 1 week. She was given Morphine which last lor 2 weeks. 
I do not recall the name on the oniment tubes (3) but both 
of these product was given to her around December of 1965. 

Neither of these medication helped her. When a person 
is real ill I was under the impression someone have to 
sign for medication such as morphine for a patient which 
is terminally ill. She was kept in the dark about the 
treatments she was receiving. She never talked about it. 

It's not fair to treat another human being as a guinea 
pig because they are poor and uneducated. Some of our 
parents didn't have the privileges we are blessed with 
today. 



385 



I took my mother back to the hospital Feb 12, 1965 
around 10:30 or 11:00. My nephew and I stayed at the 
hospital until 3:00 am I asked the receptionist if they 
were re-admitting her and she said yes we should go home 
and get some rest. When I return home my husband called 
me from his job and told me my mother had died. The people 
at the hospital never did call me to inform me of her death. 

I'm her daughter, I should have been informed about 
her death before I left the hospital. I was at the hospital 
at 3:00 am the death certificate states she died at this 
time. Feb 13, 1966. I thought the nearest relative was 
to be informed first. 



386 

How I feel about my mother participating in the experiment . 

I'm very angry about this doctor taking it upon himself 
to use poor live, uneducated human beings for his personal 
fame and gain. These human beings had the right to 
live the rest of their lives until God was ready for them 
to die. Not to die because man want to find out what effect 
it would have on soldiers in the war zone. 

My family have been deprived of what days my mother 
could have lived. I know she wasn't educated but she knew 
something was wrong but she didn't know what it was. 

I don't like it because she Lillie Wright was kept 
in the dark about this experiment. It's a disgrace to 
use high doses of radiation on anyone why didn't you 
experiment on your love one? No because they are special 
to you. Remember someday you will reap your just reward. 



387 






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April 1. 1994 



STATEMENT FOR CONGRE!iS I ONAL HEARINfi REGARDING EXCES'.; RADIATION USAGE AT 

CINCINNATI GENERAL HOSPITAL 



By: Peggy Carboina (Brooksbank) Granddaughter of John Edgar Uebster 
1049 Belvoir Lane 
Cincinnati, Ohio 45238 
(513) 451-8427 

Regarding Mr. John Edgar Uebster 



John Edqar Webster, father of Lucille H. Webster Brooksbank was admitted 
to General llosptial around January or February of 196?. He was told he 
had cancer at that time;. Also during this time my grandfather was living 
with us. meaning my moit'cr. father and brothers and sisters. I recall my 
mother telling us that the hospital had a new treatment for cancer patients 
like my grandfather. That this treatment will cure hir. cancer. My mother was 
extremely excited after hearing the news of this newly discovered treatment. 
She. as well as all of us was led to believe that thiu treatment was the 
miracle of the century. Never was any family member advised that this 
treatment was an experimental venture with the United States Government. I 
recall my grandfather i.Lating to me that after riis cancer was cured with 
this new procedure he was going to take a trip to Calilornia to visit his 
eldest son whom he had not seen in four years. Before Lhat treatments began, 
my grandfather was completely mobile, and functioned nurmally. Then the 
treatment began. 

After my grandfather's cancer treatment, he was <jary weak, confined to 
his hospital bed and could not keep any food down including water. He was 
in constant severe pain. We visted my grandfather on a daily basis. Prior^ 
to his treatment we would give him back rubs. hugs, whatever. After the 
treatment we were advised by hosptial officials not to touch his body. 
He began to lose weight rapidly. We watched him phy;ucally deteriorate 
totally. However, his mind stayed alert. He would cry due to such pain. We 
heard him pray that (iod would take him so the pain would stop. 

On the day my grandfather died, we were getting ready to go the the hosptial 
when the hospital called and advised my mother that tjrandpa was dying and 
that we should hurry. As we arrived to the floor we were met by nurses in 
front of his room telling us that my grandfather war. dead. My mother wanted 
to see my grandfather's body. The nurse refused. My mother advised the nurse 
that she wasn't afraid of him while he was alive, why would she be afraid of 
him dead. The nurse ntlll refused. My mother pushed the nurse aside and 
we entered his room. As we looked at him we noticed he had a yellowish-green 
color. Not a grey dead look. My mother asked the nurse why he was so dis- 
colored. She stated some people look that way at the time of their death. My 
mother advised that there was to be no autopsy. It wasn't until this invest- 
igation began did I discover that an autopsy was performed against the 
wishes of my mother. Never were wc advised that thit; radiation treatment was 
an experiment In any fashion. Nor were any papers granting such an experi- 
ment signed. I strongly believe that the victims of these treatments were 
used as laboratory animals to see Just how much radiation the human body 
could take. 

Respect Ively Submitted, 
Pedar^f^. Carboina 



O 



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