Professional Documents
Culture Documents
Government-Sponsored Radiation
Research on Humans 1945-1975
I
Michael McCally, MD, PhD, Christine Cassel, MD, Daryl G. Kimball
n early December 1993, a dark chapter of uncovered in media reports about radiation
the United States' cold war experience was experimentation and the Energy Secretary's
reopened when Energy Secretary Hazel (Fig 1) call for "full disclosure" and her can-
O'Leary responded to news media did statement that "For people who were
reports about government-sponsored radia- wronged ...it would seem that some compen-
tion research involving hundreds of human sation is appropriate," led to a crescendo of
subjects, often without their informed con- public interest and an escalation of the feder-
sent. At a December 7 press conference on al government's response [3]. The Energy
her initiative to declassify some of the U.S. Department opened a toll-free telephone
Department of Energy's (DOE) nuclear number to collect information from people
research records, O'Leary commented on a who believe they were subjects in improper-
series of articles about plutonium injection ly conducted radiation experiments.
experiments involving 18 subjects published Thousands of people have been unable to get
a month earlier in the Albuquerque Tribune through to the hot line, which has been
[1]. O'Leary acknowledged that these and receiving as many as 700 calls an hour [4]. At
other experiments beginning in the 1940s the time this article was written, five
involved 600 to 800 subjects and that her Congressional committees had also begun
department would soon begin to declassify inquiries into the disclosures [5,6].
and release documents concerning these and The focus of the interagency investiga-
other experiments, which were sponsored by tions, Congressional interest, and news
the DOE's predecessors, the Manhattan media coverage currently centers on a set of
Project, Atomic Energy Commission (AEC), government-sponsored radiation experi-
and the Energy Research and Development ments involving at least 695 human subjects
Administration (ERDA) [2]. from the mid-1940s into the 1970s, most of
In the following weeks, new details which were originally documented in a 1986
Congressional staff report issued by
Representative Edward Markey (D-MA) [7].
These experiments include: 1) approximately
At the time of publication, MM was Health
4 Medicine & Global Survival 1994; Vol. 1, No. 1 Government-Sponsored Radiation Research
Government-Sponsored Radiation Research McCally/Cassel/Kimball 5
San Francisco [7]; 4) 57 inmates at the Oregon follow-up studies and compensation, stating:
State Prison whose testicles were irradiated
between 1963 and 1971 [7]; 5) 64 inmates at There is no scientific reason to
the Washington State Prison involved in a expect that any of the subjects who are
similar study to determine the radiation dose not already being monitored will incur
necessary to produce temporary sterility [7]; any harmful effects. Therefore, there is
6) 11 terminally ill cancer patients injected neither any reason for attempting any
with radioactive calcium and strontium at further follow-up studies on these sub-
Columbia University and Montefiore jects, nor to propose new legislation to
Hospital, New York City, in the late 1950s to compensate them [16].
determine the rate at which radioactive sub-
stances are taken up by human tissues [71; Many DOE critics, including
and 7) 19 mentally retarded teenage boys at a Representative Markey, contend that the
state school in Massachusetts who, without report fell upon "deaf ears" partly because it
consent, were exposed to radioactive iron might have threatened the Reagan administra-
and calcium in nutritional studies [8]. tion's nuclear arms buildup of that period [16].
Investigators are also interested in inten- Barton Hacker, a historian working for
tional releases into the environment of radia- the Department of Energy, began his official
tion from government nuclear weapons agency history with his volume, Dragon's Tail:
plants, which threatened the health of plant Radiation Safety in the Manhattan Project
employees and nearby populations. 1942-1946, published in 1987, that hinted at
Information about one such experiment, but did not describe human experimentation.
known as the Green Run, began to emerge in The book does make clear that early radiation
the mid-1980s. Details about the Green Run scientists had a much clearer idea of radiation
and 12 other releases of radioactivity at three health effects, including cancer, than present
sites in three other states (Utah, New Mexico, apologists allow [17]. Barton Hacker's second
and Tennessee) were documented in a volume, Elements of Controversy: A History
Government Accounting Office (GAO) report of Radiation Safety in the Nuclear Test
released on December 16, 1993, by Senator Program, was to have been published by the
John Glenn (D-OH) [10]. With the exception of University of California Press in 1989 [18].
the Green Run, these tests were unknown to This book, which will be very useful in under-
the public before the release of this report. For standing the human experimentation pro-
a more comprehensive summary of human grams, has been denied approval by the
and environmental experiments, see Table. Department of Energy and is still unpub-
The willingness of the Department of lished, according to author Catherine Caufield
Energy and the Clinton White House to dis- and Argonne laboratory scientists [19].
close the records of human radiation research Because there is no single repository for
is new, but families, journalists, and investi- human radiation research, the files are held
gators have known of some of the experi- by government agencies, universities, hospi-
ments for many years. Many of these experi- tals, and private contractors. Many tens, if
ments have been reported in the open med- not hundreds, of additional government
ical research literature. Public interest sponsored experiments involving radiation
groups, journalists, and science writers have exposure may have been conducted. The full
described many of these experiments on the extent of radiation research on humans will
basis of interviews with subjects and families not be known for months, possibly years. The
[11-15]. In proceedings well covered in the DOE and other agencies argue that release of
press, the work of Eugene Saenger, a many relevant documents will require their
Cincinnati radiologist, was brought before declassification. There is an active debate
the American College of Radiology in the late within government about whether and how
1960s. Eugene Saenger was cleared of uneth- long research materials ought to remain clas-
ical conduct in irradiating cancer patients sified. Given the harm that was evidently
without informed consent for military and done, the likelihood of litigation, and public
space science, not medical, objectives [9]. concern about environmental radiation cont-
However, the government agencies, uni- amination, it is likely that this story will
versities, hospitals, and the scientists unfold in Congress and the courts over a
involved have long resisted release of any period of years.
information concerning these studies. In
February 1987, in response to Representative
Markey's committee report, "American
Concerns Raised By the
Nuclear Guinea Pigs," the Energy Several issues ought be kept in mind as
Disclosures
Department rejected the report's conclusions we seek to understand what happened and
and strongly rejected recommendations for why it happened. Full disclosure is the first
6 Medicine & Global Survival 1994; Vol. 1, No. 1 Government-Sponsored Radiation Research
and most important task. What was done, including the Department of Defense (DOD),
when, and to whom? It seems clear that in the National Aeronautics and Space
many of these studies the subjects were not Administration (NASA), the Veterans
fully informed, if at all, about the nature of Administration, the Department of Health
the research and risks that it might entail. All and Human Services (DHHS) (formerly the
the research subjects who are still alive clear- Department of Health, Education and
ly deserve to be informed. Subsequent med- Welfare), and the Central Intelligence
ical care for these subjects may be altered on Agency (CIA).
the basis of knowledge of their prior radia- In January, President Clinton established
tion exposure. The provision of adequate a Human Radiation Interagency Working
medical follow-up will be an important crite- Group to coordinate a government-wide
rion in the evaluation of these experiments. If effort to discover the "nature and extent" of
evidence can be developed that subjects were government-sponsored experiments involv-
harmed or wrongly experimented upon, ing exposure to ionizing radiation. The Group
compensation will be appropriate. National includes the Secretaries of Energy, Defense,
security can no longer be used as an official Health and Human Services, and Veterans
reason for not releasing complete informa- Affairs, the Attorney General, the
tion concerning these investigations. Administrator of NASA, and the Directors of
Second, were the experiments ethical by the CIA and the Office of Management and
today's or prior standards? What judgments Budget (OMB). The group will be supported
and rationales did the research scientists use? by the Advisory Committee on Human
Most importantly, do we have adequate pro- Radiation Experiments. The advisory com-
tections and procedures in place for subjects mittee will be led by Ruth Faden of Johns
in human experimentation in the future? Hopkins University School of Hygiene and
Third, can scientists in military or other Public Health. The review is intended to be
"mission" agencies conduct human experi- limited to intentional exposures of individu-
mentation at all, or are conflicts of interest als or environmental releases of ionizing radi-
inevitable and unresolvable? What are the ation [20].
right policies for conduct of human research Other government research programs
by the military? involving human experimentation might log-
A final task will be to reassure the public ically be included in a comprehensive
that radiation and nuclear medicine, with review, such as studies done in the develop-
appropriate safeguards, currently have a ment of chemical and biological weapons and
unique role in medical diagnosis and treat- countermeasures to their use. Little is known
ment. Public fear of radiation and mistrust of publicly about these highly classified pro-
the government and even of physicians will grams. According to a National Academy of
be heightened by these disclosures. Sciences report in 1993 [21], more than 4,000
Physicians must reaffirm the benefits and rel- military recruits were used to test mustard
ative safety of current medical uses of radia- gas and other agents in tests during and after
tion and nuclear medicine while acknowledg- World War II. Some propose that the subject
ing the inappropriateness and harm of some to be reviewed is all government-sponsored
of the experimentation now being disclosed. testing programs involving human subjects,
including the testing programs of the Food
and Drug Administration. However, the pre-
sent investigation is likely to be limited by
Scope of the Problem: Who Was
the Clinton administration to the human
Affected?
At the outset of an investigation into radiation experimentation issue.
radiation research experimentation it will be
necessary to establish what specific types of
research are to be included. These definitions
Relationship To Environmental
8 Medicine & Global Survival 1994; Vol. 1, No. 1 Government-Sponsored Radiation Research
individual assessment. It will be important to tration of whole-body gamma radiation to
identify and consider the purposes of the human beings. Cancer patients were given
experiment, the quality of the research design sublethal (100 to 300 rad) whole-body doses
(if any), the intended use of the information in various exposures and their responses
gained, the character and competence of the studied. Although the patients did in fact
subjects, the use and quality of informed con- have terminal cancer, the research protocols
sent, and whether there was appropriate were not designed as tests of advanced can-
medical follow-up. cer therapy. The results of these investiga-
The aims of the research varied. A num- tions were published in military medical
ber of the studies were clearly performed for journals and conferences and are not in the
military purposes. In the aftermath of cancer therapy literature [33,34,36].
Hiroshima, during the period of atmospheric It should be noted that several of the
testing, the military and the nuclear weapons studies reviewed in the Markey subcommit-
production industry sought information tee report were done in leading medical
about the biological activity of plutonium research facilities by highly regarded medical
and the radioisotopes of atmospheric fallout. experts. Informed consent consistent with
The toxicity of plutonium was of particular pre-1976 standards was obtained and only
concern because the metal was extracted trace amounts of radioactive material were
from reactor rods and milled and machined used. The information sought was clearly for
for bomb components. Some former AEC sci- improvement of medical therapy, as, for
entists claim that plutonium administration example, in the diagnosis and treatment of
to human subjects was used to gather infor- thyroid disease where radioiodine is today a
mation for setting safety standards for standard agent.
weapons production workers and scientists.
Plutonium has no medical uses [31].
Information on radioiodine, strontium, Scientific motivation and behavior must
The Scientists' Motives
cesium, and other fallout isotopes was sought also be criteria in review of these cases. The
to justify the unfounded claims of the safety claim has been reported in the press that the
of atmospheric nuclear testing. ethical standards for the conduct of medical
In the 1950s, military scientists sought research were different 40 years ago and, fur-
information about sublethal and lethal radia- ther, that cold war military threats justified
tion doses of direct gamma (X-ray) radiation human experimentation [37]. But the ethical
for the design of radiation weapons, the neu- principles of scientific research were not
tron bomb, and battlefield nuclear weapons, invented recently. The Nuremberg Principles
as well as to support technology for fighting arising from the trial of Nazi war criminals
in areas of high radioactive fallout [32-34]. for crimes including cruel and lethal human
Studies in which soldiers marched into areas experimentation were well known to all
under atmospheric nuclear weapons detona- American scientists as soon as they were
tions clearly served only military purposes. published in 1949 [38,39]. American scientists
As biological science, the research objectives doing hazardous human experimentation in
clearly could have been accomplished by ani- Air Force and NASA laboratories referred to
mal studies or simulations. No clear scientif- these principles and published standards for
ic or military justification for these human the conduct of research in which humans
exposures has been offered [12-14]. Finally, were subject to dangerous aerospace envi-
the manned space program and President ronments [40]. In a 1950 memorandum to Dr.
Kennedy's challenge to place a man on the Shields Warren, the chief medical officer of
moon created the requirement to investigate the AEC, Dr. Joseph Hamilton, a San
the effects of large bursts of gamma radiation Francisco neurologist and scientist in the plu-
that unprotected astronauts might receive tonium injection studies, suggested that the
from solar flares. Testicular function was of experiments might have "a little of the
particular concern because the astronauts Buchenwald touch," reflecting clear under-
were all young men in the prime of their standing of medical experiments by Nazi
reproductive years [35]. prison camp doctors [41].
Human studies for military or space However, in 1945, there were no clear
flight requirements can easily be distin- standards of informed consent or mecha-
guished from studies for the purposes of nisms for monitoring the process of obtaining
improving medical diagnosis and treatment. and documenting such consent. Scientists
Occasionally, medical treatment was used by were considered to be responsible and, when
government scientists or sponsors as a justifi- full disclosure was not made, rationalizations
cation for research whose purpose was mili- about patient's peace of mind or minimal risk
tary. For example, at Oak Ridge, a facility were common. In some cases, national securi-
was constructed in the 1960s for the adminis- ty was blanket permission for secrecy and
10 Medicine & Global Survival 1994; Vol. 1, No. 1 Government-Sponsored Radiation Research
was the culture of secrecy and deception Becoming the subject of someone else's exper-
within DOE and military research units. iment, however, is such a dramatic infringe-
Third, the most important goal in the open ment of personal civil rights that it may be
examination of these events should be the done ethically only in the context of fully
creation of guidelines that would prevent informed consent and voluntary altruism.
abuses from occurring in the future. The centrality of informed consent to the
ethical use of human subjects in research was
established as an internationally accepted
The primary ethical principle of research principle by the Nuremberg Military
Informed Consent
with humans is informed consent. This has Tribunal in 1949, reiterated by the Helsinki
been a fundamental standard in medical care Code of the World Medical Association in
for almost a century, articulated by the courts 1963, and updated in 1975 [38,46]. In addition
as well as by professional societies. Thus, to requiring the informed consent of the sub-
even when a medical treatment is indicated ject, these codes require that the experiment
to treat a disease from which the patient is be of worthy enough scientific value to justi-
suffering, and no research is involved, it is fy any -- even minimal -- risk to the subjects,
still required that the patient be fully that the investigators guard the subjects
informed about risks, benefits, and alterna- against all possible foreseeable pain, suffer-
tives and that he be permitted to refuse ing, or disability, and that the subjects be able
potentially beneficial treatment. Before to withdraw from the study at any time. It is
World War I, the American jurist Benjamin likely that most medical investigators in the
Cardozo articulated the doctrine as follows: 1950s knew the Nuremberg Code; but until
"Every human being of adult years and the 1960s, there was no law in the United
sound mind has a right to determine what States that specifically protected the rights of
shall be done with his own body" [44]. the subjects of medical research [47].
The doctrine of informed consent grew
within case law after World War II as part of
the growth of malpractice litigation. It was Federal oversight of research with
Government Oversight
established that physicians were required to human subjects began in the United States
inform patients of potential risks of medical with the 1962 amendments to the Federal
treatments. Since it is virtually never possible Food, Drug, and Cosmetic Act, which
for a layperson to be as well informed as the required that the investigator obtain the con-
physician about complex medical issues, the sent of the subject to receive an experimental
standard of informed consent that developed drug "...except where they deem it not feasi-
was the "community standard," i.e., the ble or, in their profession al judgment, con-
physician was required to disclose only as trary to the best interests of such human
much as was the standard of practice by beings..." (FFDCA, Section 5 5 [i]) The regula-
other physicians in his community. In med- tions promulgated in 1966 allowed for no
ical treatment the best interests of the patients exceptions to the informed consent rule in
themselves are the motivation for whatever "nontherapeutic" research, i.e., that which
risks are involved; in most research the bene- offered no possibility of treating a disorder
fit is to other, future, and unknown persons that the subject suffered from.
and, therefore, the subject's participation In 1966, the National Institutes of Health
requires even more rigorous ethical stan- (NIH) adopted requirements that each insti-
dards, especially that of informed consent, to tution receiving federal funds provide assur-
ensure respect for the person. ance of the existence of a system of peer
Hans Jonas has eloquently argued that review that ensured that studies protect the
medical research is an optional human goal of rights and welfare of the subjects, obtain
relative rather than absolute value, because it informed consent, and have a reasonable
risks objectifying and using another human assessment of risk and potential benefits of
being for purposes that are not his or her own the research. These three stipulations are at
[45]. Every major ethicist writing about the core of both the Nuremberg Code and the
human research argues that it is dangerous to Helsinki Declaration.
the moral fabric of society to consider poten- In the late 1960s and early 1970s, numer-
tial social goals as higher values than respect ous unethical human research practices by
for the individual, especially in the frame- respected, and often federally funded,
work of research potentially affecting the researchers were disclosed. A classic article
physical or psychological integrity of the per- by Henry K. Beecher in 1966 in the New
son. Individuals are called on to relinquish England Journal of Medicine catalogued
autonomy in society for goods that they rec- numerous such research projects [39]. The
ognize as social, such as civic government, Tuskegee study came to light, in which effec-
education, and public health standards. tive treatment of syphilis had been withheld
12 Medicine & Global Survival 1994; Vol. 1, No. 1 Government-Sponsored Radiation Research
lems. Here the studies were not intended to of unethically obtained data.
study effects on human beings, but potential- The government's policy with regard to
ly thousands of people were unknowingly these disclosures should respond to the per-
exposed to radiation for the sake of experi- vasive public fear of radiation. Policy should
ments related to understanding spread of focus on improving radiation protection pro-
fallout or interpretations of aerial intelligence grams and on efforts to restore public confi-
over the Soviet Union. The humans exposed dence in the agencies responsible for radia-
were not studied for any potential medical tion health and safety. Only then can trust in
effects, violating another tenet of the the government's assertions of safety be
Nuremberg code and requiring the expensive restored. This restoration will require
and difficult dose reconstruction studies cur- acknowledgment of the previous policy of
rently conducted by the CDC. secrecy and, in some cases, frank deception,
as well as clear statements from the govern-
ment about how such abuses will be prevent-
Justice requires that persons who are ed in the future.
Vulnerable Persons
intrinsically vulnerable to exploitation, Up till now, it has been U.S. government
unable to speak for themselves, or represen- policy, with regard to health and radiation
tative of disadvantaged groups not be used from nuclear weapons production and radia-
as subjects of research unless the research tion exposures in general to give blanket
addresses a problem specific to that group reassurance that the health of workers and of
that cannot be as easily done in a more gen- the general public has been fully protected
eral population. The Oak Ridge whole-body and that there has been no risk of disease or
radiation experiments, which used enormous injury from radiation in the United States. It
doses, are probably examples of studies so has been the policy of the DOE in recent
potentially dangerous that information to be administrations to avoid examination of
gained would not have warranted approval available health effects data and not to allow
of these studies, even if informed consent had independent research scientists to explore
been obtained, which it had not [52,53]. That claims of harm. Secrecy in the name of
the subjects were said to be terminally ill is national security, data ownership, and sub-
not a justification. In fact, by criteria drawn ject confidentiality has limited independent
from the Nuremberg and Helsinki Codes and scientific review of government information
further articulated by the National on radiation health effects [28].
Commission, these subjects would be consid-
ered especially vulnerable to exploitation
and, therefore, the ethical standards for Perhaps the most important recommen-
National Review Panel
research are even stricter. dation to be made at this time is to establish a
By these standards, nursing home resi- national, impartial, and credible scientific
dents or retarded people in institutions and ethical review process for the evaluation
should not be subjects of research unless the of each of the individual cases. Such a panel,
studies apply directly to their own well-being like the previous National Institute of Health
and could not be done using other subjects. Ethics Advisory Board, should be national in
In particular, institutionalized populations scope and have authority to review all
are not to be used only because it is more con- research in which governmental agencies are
venient for the investigator. The study of involved in any way. There should not be a
nutritional physiology done in retarded chil- special body just to review radiation-related
dren in Massachusetts apparently violates research because there are many other issues
this principle, but reflects widespread prac- of potential ethical concern that are hard to
tice among legitimate investigators of the predict or categorize at this point. The mem-
time who commonly used institutionalized bers should include appropriate scientists,
populations for their research simply because ethicists, public officials, and legal scholars. It
it was more convenient [7]. should be charged to review prospectively
selected proposed studies as well as develop
broad policy regarding generally difficult or
controversial areas of research.
Recommendations
The panel ought to review all present
The U.S. government must review and and past government experimentation with
Government Policy
correct its policies regarding: secrecy and human subjects to inform our future policies
declassification of research reports, ethics of regarding medical follow up and compensa-
the conduct of human experimentation, com- tion. The panel would also analyze published
pensation for unethical research, guidelines and unpublished research reports to establish
for human experimentation in mission labo- the purpose, experimental design, consent,
ratories, mistrust of government, and the use and other scientific ethical and appropriate-
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16 Medicine & Global Survival 1994; Vol. 1, No. 1 Government-Sponsored Radiation Research
Government-Sponsored Radiation Research McCally/Cassel/Kimball 17