DISCLAIMER

The following is a staff memorandum or other working document 
prepared for the members of the Advisory Committee on Human
Radiation Experiments.  It should not be construed as representing
the final conclusions of fact or interpretation of the issues. 
All staff memoranda are subject to revision based on further 
information and analysis.  For conclusions and recommendations of
the Advisory Committee, readers are advised to consult the Final
Report to be published in 1995.


			STAFF MEMORANDUM



TO:	Members of the Advisory Committee on Human 
	Radiation Experiments

FROM:	Advisory Committee Staff

DATE:	June 30, 1994

RE:	Total-Body Irradiation -- An Overview



	The Committee's interest in the "Cincinnati experiments" 
highlights the larger topic of total-body irradiation (TBI) 
experiments as an important area of inquiry.  As a general 
category, we intend for TBI to mean those instances in which an 
external radiation source has been used to irradiate the entire 
body of the experimental subject.  A closer examination of 
experimentally administered TBI is useful for a number of reasons.

	There is a rich history of information because intentional 
TBI has been employed on humans for over 70 years, by scores of 
medical institutions, resulting in thousands of cases.  The 
institutions involved in TBI represent a cross-section of private, 
academic, and government interests whose motives were not always the 
same.  (See Attachment 1 for list of institutions.) The government 
had a clear military and space interest in learning about the effects 
of TBI on the human body.  The sources of data for studying the 
effects of TBI on humans include the populations exposed to atomic 
weapons and tests (principally persons in Hiroshima and Nagasaki, the 
Marshall Islanders, atomic veterans, uranium miners, and persons 
downwind from atomic weapons tests), victims of radiation accidents 
and other exposures, and patients receiving radiation treatment.

	The staff has begun to review material that it has received 
from several sources, such as: files from the University of 
Cincinnati (including parts of Dr. Saenger's files) provided by the 
Department of Defense; files provided by the DOD on radiation exper
iments;  files from the Medical Division at Oak Ridge provided by the 
Department of Energy; records provided by NASA; and the 1981 Hearings 
on the Human Total Body Irradiation Program at Oak Ridge before the 
Subcommittee on Investigations and Oversight of the House Science and 
Technology Committee, 97th Cong., 1st Sess. (Sept. 23, 1981) 
(commonly referred to as the "Gore Hearing").

	The full TBI experiment story remains to be told.  Among the 
key issues to explore to help determine the extent to which 
government funds and military/space interests influenced the research 
are:  the initial development of TBI research at the various ins
titutions; the balance between therapeutic treatment and 
military/space oriented research on radiation effects; and the 
evolving standards of practice that guided the practitioners at each 
of the institutions.


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	Attached are materials that provide a background on some of 
the major activities involving TBI experiments.

1.	Attachment 1 is a list of the 45 "Cooperating Institutions in 
[the Oak Ridge] Retrospective Studies" sponsored by the AEC and NASA, 
from the Oak Ridge TBI Final Report (Attachment 4, below), and an 
earlier list of 38 institutions that includes audit information.

2.	Attachment 2 is a 1957 article by Drs. Lowell Miller, Gilbert 
Fletcher, and Herbert Gerstner on "Systemic and Clinical Effects 
Induced in 263 Cancer Patients by Whole-Body X-Irradiation with 
Nominal Air Doses of 15 to 200 R" (School of Aviation Medicine, USAF, 
No. 57-92, May 1957).  It describes the initial results of an Air 
Force TBI Study from 1951-56 to learn about the effects of radiation 
on pilots.  The program was sponsored by the School of Aviation 
Medicine, Randolph Air Force Base, Texas and run by the University of 
Texas and the M.D. Anderson Hospital and Tumor Institute in Houston 
from 1951 through 1956.

3.	Attachment 3 contains abstracts prepared by the Armed Forces 
Radiobiology Research Institute (AFRRI), describing Army sponsored 
TBI research, through the Research and Development Division of the 
Office of the Surgeon General (the contracts were funded through the 
Armed Forces Special Weapons Project [AFSWP] and subsequently the 
Defense Atomic Support Agency [DASA]).  In one project, the Baylor 
University College of Medicine and the Texas Medical Center conducted 
research from 1953-1964 on the "Effect of Total-Body Irradiation on 
Immunologic Tolerance of Bone Marrow and Homografts of Other Living 
Tissue."  Drs. Vincent P. Collins and Kenneth Loefler were the 
principal investigators.  A total of 112 cancer patients were treated.

A second project was conducted by the Sloan Kettering Institute for 
Cancer Research to study Post-Irradiation Syndrome in Man under the 
direction of Dr. James J. Nickson (again under an AFSWP contract).  
This program involved a total of 34 cancer patients: 22 received 
total-body irradiation, and 12 received radiation to the head.

4.	Attachment 4 contains excerpts from the 1975 final report of 
the joint AEC/NASA "Retrospective Study of Radiation Effects," 
conducted at Oak Ridge Medical Division by R.C. Ricks and C.C. Lushbaugh, 
entitled "Studies Relative to the Radiosensitivity of Man: Based on th
e Retrospective Evaluations of Therapeutic and Accidental Total-Body 
Irradiation--Final Report" (Oak Ridge Associated Universities, Sep. 
1, 1975) ("Oak Ridge TBI Final Report").  This study was the 
outgrowth of a collaboration between the AEC and NASA to, among other 
things, conduct a comprehensive review and analysis of all known data 
from clinical TBI cases ("Retrospective Study") and to engage in new 
research that could undertake measurement specified by NASA 
("Prospective Study"). The Retrospective Study ultimately collected 
data from 45 institutions totalling over 2500 cases.  (The list of 
institutions is included in Attachment 1.)  Some of the data was used 
in the National Academy of Science's 1967 report on "Radiobiological 
Factors in Manned Space Flight."


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5.	Attachment 5 contains excerpts from the proceedings of a 1967 
Oak Ridge conference on "Dosimetry of Total-Body Irradiation by 
External Photon Beams" (Feb. 23-24, 1967), one of many conferences 
at which  data from the Oak Ridge Retrospective Study was presented.  
It includes  a descriptive lists of the 38 institutions and 1814  
patients from which data had been accumulated to date.

6.	Attachment 6 is an excerpt from the 1966 annual report of the 
Oak Ridge Medical Division, describing the Retrospective Study and 
noting that the data from Oak Ridge studies were valuable in 
understanding space radiation risks and were to be included in the 
1967 National Academy of Science's report on radiation effects in 
space (see no. 3, above).

7.	Attachment 7 is the 1974 AEC "Program Review of the Medical 
Division of Oak Ridge Associated Universities," which recommended 
cessation of Oak Ridge clinical programs. The TBI programs "were 
viewed as evolving without adequate planning, criticism or 
objectives, and have achieved less in substantial productivity than 
merits continued support."  (The testimony of Andrew J. Stofan, then 
NASA Acting Associate Administrator for the Office of Space Science, 
before 1981 Gore Hearing, in which he notes that NASA destroyed its 
records on the Oak Ridge Project in 1980, is attached to the NASA 
report at Tab K.)

8.	Attachment 8 is a list of additional articles that the staff 
has obtained and conferences that were referenced in these articles.  
Please contact staff if you would like copies of any of these 
materials.	

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