From the Final Report of the Advisory Committee on Human Radiation Experiments:
“Research involving human subjects continues to be essential to the progress of medical science, since most advances in medicine must at some point in their development be tested in human subjects.
Every one of us who has been either a patient or a loved one of a patient has
benefited from knowledge gained through research with human subjects. But
medical science, like all science, does not proceed or progress without the taking
of risks. In medical research, these risks often fall on the human subject, who
sometimes does not stand to benefit personally from the knowledge gained. This
is the source of the moral tension at the core of the enterprise of research
involving human subjects. In order to secure important collective goods–
scientific knowledge and advances in medicine–individuals are put in harm’s
way. The moral challenge is how to protect the rights and interests of these
individuals while enabling and encouraging the advancement of science.” (page 2)
“One-half century ago, the U.S. government and its experts in the
fields of radiation and medicine were seeking to learn more about radiation in
order to protect workers, service personnel, and the general public against
potential atomic war and individuals against the menace of disease.
soldiers, and others as experimental subjects. It acted through the experts to
whom we regularly entrust the well-being of our country and our selves: elected
officials, civil servants, generals, physicians, and medical researchers.
Moreover, the government acted with full knowledge that the use of
individuals to serve the ends of government raises basic ethical questions. If, as
we look back, there could be doubt about the importance of the matter to the
leaders of the time, we need only look to the appearance before the U.S. Senate of
David Lilienthal, who had been nominated to serve as the first chairman of the
Atomic Energy Commission, the civilian successor to the Manhattan Project and
the predecessor to today’s Department of Energy. In his testimony, Lilienthal
Toward these laudable ends, the government used patients, workers,
. . . all Government and private institutions must be
designed to promote and protect and defend the
integrity and the dignity of the individual. . . . Any
forms of government . . . which make men means
rather than ends in themselves . . . are contrary to
this conception; and therefore I am deeply opposed
to them. . . . The fundamental tenet of communism
is that the state is an end in itself, and that therefore
the powers which the state exercises over the
individual are without any ethical standards to limit
them. This I deeply disbelieve.’
What did happen when individuals were sometimes used as means to
achieve national goals? How well were the national goals of preserving the peace
and advancing medical science reconciled with the equally important end of
respect for individual dignity and health? What rules were followed to protect
people, and how well did they work? Was the public let in on the balancing of
collective and individual interest? In what sense did the public, in general, and
individuals, in particular, know what was happening and have the opportunity to
provide their meaningful consent?” (page 13)
“Medical researchers, especially those expert in radiation, were not
oblivious to the importance of the special roles they were being asked to play.
“Never before in history,” began the 1949 medical text Atomic Medicine, “have
the interests of the weaponeers and those who practice the healing arts been so
closely related.”‘ This volume, edited by Captain C. F. Behrens, the head of the
Navy’s new atomic medicine division, was evidently the first treatise on the topic.
It concluded with a chapter by Dr. Shields Warren, the first chief of the AEC’s
Division of Biology and Medicine, who would become a major figure in setting
policy for postwar biomedical radiation research. While the atomic bomb was not
“of medicine’s contriving,” the book began, it was to physicians ”more than to any
other profession” that atomic energy had brought a “bewildering array of new
problems, brilliant prospects, and inescapable responsibilities.” The text, a
prefatory chapter explained, treats “not of high policy, of ethics, of strategy or of
international control [of nuclear materials], as physicians these matters are not for
us.”‘ Yet what many readers of Atomic Medicine could not know in 1949 was
that Behrens, along with Warren and other biomedical experts, was already
engaged in vigorous but secret discussions of the ethics underlying human
radiation experiments. At the heart of these discussions lay difficult choices at
the intersection of geopolitics, science, and medicine that would have a
fundamental impact on the federal government’s relationship with the American
people.” (page 21)
“As difficult and inconvenient as it might have been for researchers in the
boom years of American medical science following World War I1 to confront the
fundamental differences between therapeutic and nontherapeutic relationships
with other human beings, it was not impossible. Otto E. Guttentag, a physician at
the University of California School of Medicine in San Francisco, directly
addressed these issues in a 1953 Science magazine article. Guttentag’s article, and
three others that appeared with it, originated as presentations in a symposium held
in 1951 on “The Problem of Experimentation on Human Beings” at Guttentag’s
home institution. Guttentag constructed his paper around a comparison between
the traditional role of the physician as healer and the relatively new role of
physician as medical researcher. Guttentag referred to the former as “physicianfriend”
and the latter as “physician-experimenter.” He explicitly laid out the
manner in which medical research could conflict with the traditional doctorpatient
Historically, . . . one human being is in distress, in
need, crying for help; and another fellow human
being is concerned and wants to help and the desire
for it precipitates the relationship. Here both the
healthy and the sick persons are . . . fellowcompanions,
partners to conquer a common enemy
who has overwhelmed one of them. . . . Objective
experimentation to confirm or disprove some
doubtful or suggested biological generalization is
foreign to this relationship . . . for it would involve
taking advantage of the patient’s cry for help, and of
his insecurity .”
Guttentag worried that a “physician-experimenter” could not resist the
temptation to “tak[e] advantage of the patient’s cry for help.”” To prevent the
experimental exploitation of the sick that he envisioned (or knew about),
Guttentag suggested the following arrangement:
Research and care would not be pursued by the
same doctor for the same person, but would be kept
distinct. The physician-friend and the physicianexperimenter
would be two different persons as far
as a single patient is concerned. . . . The
responsibility for the patient as patient would rest,
during the experimental period, with the physicianfriend,
unless the patient decided differently.
Retaining his original physician as personal adviser,
the patient would at least be under less conflict than
he is at present when the question of
Among physicians, Guttentag was nearly unique in medicine in those days
in raising such problems in print. Another example of concern about the moral
issues raised by research at the bedside comes from what might be an unexpected
source: a Catholic theologian writing in 1945. In the course of a general review
of issues in moral theology, John C. Ford, a prominent Jesuit scholar, devoted
several pages to the matter of experimentation with human subjects. Ford was not
a physician, but his thoughts on this topic–published a year before the beginning
of the Nuremberg Medical Trial–suggest that a thoughtful observer could
recognize, even decades ago, serious problems with conducting medical research
on unconsenting hospital patients:
The point of getting the patient’s consent [before
conducting an experiment] is increasingly
important, I believe, because of reports which
occasionally reach me of grave abuses in this
matter. In some cases, especially charity cases,
patients are not provided with a sure, well-tried, and
effective remedy that is at hand, but instead are
subjected to other treatment. The purpose of
delaying the well-tried remedy is, not to cure this
patient, but to discover experimentally what the
effects of the new treatment will be, in the hope, of
course, that a new discovery will benefit later
generations, and that the delay in administering the
well-tried remedy will not harm the patient too
much. . . . This sort of thing is not only immoral,
but unethical from the physician’s own standpoint,
and is illegal as well.” (pages 141-142).
Economically disadvantaged patients seem to have been perceived by
some physicians as particularly appropriate subjects for medical experimentation.
Dr. Beeson offered a frank description of a quid pro quo rationale that was
probably quite common in justifying the use of poor patients in medical research:
“We were taking care of them, and felt we had a right to get some return from
them, since it wouldn’t be in professional fees and since our taxes were paying
their hospital bills.”49 (page 146)
The future of the metabolism work at Rochester apparently was decided
when Shields Warren was named the first chief of the AEC’s Division of Biology
and Medicine in fall 1947. In his private diary for December 30, 1947, Warren
tersely noted: “Ordered abandonment of human isotope program at Rochester.”‘ “)
The program at the University of California at Berkeley, however, continued. On
December 4, 1947, Shields Warren had met with Hamilton and Stone;'” the
decision to allow the program to continue clearly was not a hasty one. A 1974
recollection of Shields Warren indicates that his decision to allow the program to
continue may have been due to Hamilton’s assertion in December 1947 that it had
been the University of California’s practice to obtain some form of
(undocumented) consent. ”I
According to Warren, Hamilton had said that subjects were told “they
would receive an injection of a new substance that was too new to say what it
might do but that it had some properties like other substances that had been used
to control growth processes in patients, or something of that general ~ort.”‘~’
Warren went on to observe that “you could not call it informed consent because
they did not know what it was, but they knew that it was a new and to them
unknown substance.””3 (pages 255 -256)
“First, the nation must provide for appropriate remedies as it comes to grips
Second, the nation must provide improved means to better ensure that
with the past.
Those who conduct research involving human subjects act in a manner consistent
with the interests and rights of those who may be put at risk and consistent with
the highest ethical standards of the practice of medicine and the conduct of
In the conduct of human subject research and environmental releases in a context
where these activities must occur in secret.
accounting can be made to those who are asked to bear risks, particularly when
any or all of the risk taking involves secrecy. Moreover, these records should be
made available to the public at large on a timely basis consistent with legitimate
Third, the nation must ensure that special care is taken to prevent abuses
Fourth, the nation must ensure that records are kept so that a proper
national security requirements…..the Committee has focused on past experiments in which there was no possibility that subjects could derive medical benefit from being in the research or in which the potential for this benefit is in dispute. These were the
experiments that raised the greatest public concern. They were also the
experiments that raised the greatest concern for most members of the Committee
when we considered the 1944-1974 period. This was a time, as noted throughout
this report, when it was common for physicians to use patients as research
subjects without the patients’ knowledge or consent.
(pages 770, 771)
FINDINGS (ACHRE FINAL REPORT)
Findings for the Period 1944-1974
The Advisory Committee finds that from 1944 through 1974 the
government sponsored (by providing funding, equipment, or radioisotopes)
several thousand human radiation experiments. In the great majority of
cases, the experiments were conducted to advance biomedical science; some
experiments were conducted to advance national interests in defense or space
exploration; and some experiments served both biomedical and defense or
space exploration purposes.
These experiments were conducted by researchers affiliated with
government agencies, universities, hospitals, and other research institutions. Only
fragmentary information survives about most experiments.
The Advisory Committee finds that the majority of human radiation
experiments in our database involved radioactive tracers administered in
amounts that are likely to be similar to those used in research today. Most of
these tracer studies involved adult subjects and are unlikely to have caused
physical harm. However, in some nontherapeutic tracer studies involving
children, radioisotope exposures were associated with increases in the
potential lifetime risk for developing cancer that would be considered
unacceptable today. The Advisory Committee also identified several studies
in which patients died soon after receiving external radiation or radioisotope
doses in the therapeutic range that were associated with acute radiation
Review of available information indicates that the majority of the
approximately 4,000 human radiation experiments in the Advisory Committee
database involved the use of radioisotopes as tracers in research designed to
measure physiological processes in either normal or diseased states. These
experiments were not typically aimed at measuring the biological effects of
radiation itself. However, information on the majority of experiments in our
database was fragmentary and thus did not allow for detailed estimates of
dosimetry or examination of issues of experimental design and subject selection.
To supplement the information in our database and provide context to our
analysis, we independently reviewed archival documents from AEC-mandated
institutional local isotope committees. These local use committees were part of a
larger AEC program that facilitated the distribution of radioisotopes for use in
government-sponsored human subjects research in the 1947- 1974 period and
involved the review of experimental risk on an individual basis to ensure that
human uses of isotopes were within accepted risk standards of the day. We thus
used these materials as an indicator of isotope use and regulatory practices at that
While we recognize the limitations of the data available to us, our
evaluation suggests that most tracer studies conducted during the period 1944-
1974 likely involved low doses that did not cause any acute or long-term effects.
The Advisory Committee cannot rule out, however, the possibility that some
people were or will be harmed as a consequence of their involvement in these
The Committee did identify some nontherapeutic tracer experiments
involving the administration of iodine 13 1 to children, which may have raised the
subsequent risk of developing thyroid cancer to levels that would be considered
unacceptable today. Based on the average risk estimate for each experiment,
approximatedly 500 individuals were exposed to greater than minimal risk. (The
Committee used a threshold of greater than or equal to one excess case of cancer
per 1,000 subjects for categorizing experiments as greater than minimal risk.)
Combining the average risk estimates for each experiment, this translates into an
expected excess of 1.3 incident cases of thyroid cancer for the entire group.
Fortunately, unlike many other cancers, thyroid cancer is curable in more than 90
percent of cases; therefore, it is unlikely that, even if cancers developed, these
exposures caused any premature deaths. Furthermore, although there is strong
scientific evidence that radiation doses delivered over a short period of time from
external sources can result in increases in cancer incidence at specific sites,
comparable data suggest that the carcinogenic effects of isotope exposures are
less than those of external irradiation. The difference in carcinogenic effect is
thought to be due to the relatively low dose rate of the isotope exposure, which
allows for effective repair of radiation damage.
One additional isotope study involving the administration of radioiron to
pregnant women has been linked to a possible increase in cancers in children who
were exposed in utero. However, the small number of observed cancers as well
as considerable uncertainties in the amount of radioisotope administered have
made the determination of causality difficult. Finally, the Committee found some
experiments where radioisotope exposures were associated with either acute or
chronic physiologic changes of uncertain clinical significance, pathologic
evidence of kidney damage secondary to chemical and radiation toxicity in some
patients injected with uranium, and radiographic evidence of minimal bone
changes in some long-term survivors of plutonium injections.
most part performed on patient-subjects where there was, at least arguably, a
prospect that the subjects might benefit medically from the exposure. However,
the TBI and experimental gallium treatments, in which patients suffered
symptoms of acute radiation sickness and died soon after treatment, raise the
question of whether their deaths were hastened by the radiation treatments.
Resolution of this issue requires review of individual medical histories, which the
Advisory Committee could not undertake.
Studies that involved radiation doses in the therapeutic range were for the
The Advisory Committee finds that human radiation experimentation
during the period 1944 through 1974 contributed significantly to advances in
medicine and thus to the health of the public.
Human radiation research was essential to the development of new
therapies such as the use of radioactive iodine to treat thyroid cancer; the use of
phosphorus to treat blood diseases such as polycythemia vera; and the use of
radioactive strontium as a palliative in prostate and other cancers metastasized to
the bone. Diagnostic uses of radionuclides developed during this period include
scanning techniques to identify tumors and radiolabeling techniques that help
evaluate a variety of cardiac diseases. The quality of images produced by
external sources of radiation also improved dramatically between 1944 and 1974,
making possible, for example, techniques such as balloon angioplasty to open
The Advisory Committee finds that some government agencies
required the consent of some research subjects well before 1944. These
requirements generally did not stipulate what was meant by consent,
however, nor did they generally indicate whether investigators were
obligated to disclose specific information to potential subjects. The
government did not have comprehensive policies requiring the consent of all
subjects of research, including both healthy subjects and patient-subjects,
4a. Research Involving Healthy Subjects: In the 1920s, the Army
promulgated a regulation concerning the use of “volunteers” for medical research.
In 1932, the secretary of the Navy required that subjects of a proposed experiment
be “informed volunteers.” In 1942 the requirement that healthy subjects be
informed volunteers was also articulated by the Committee on Medical Research,
which oversaw war-related research for the Executive Office of the President. In
1953, the principle of consent articulated in the Nuremberg Code was adopted by
the Department of Defense in a Top Secret memorandum from Secretary of
Defense Charles Wilson regarding human research related to atomic, biological,
and chemical warfare (this document is known as the Wilson memorandum); in
1954, this application of the Nuremberg Code was expanded by the Army Office
of the Surgeon General as an unclassified policy for all research with “human
volunteers.” A policy of requiring researchers to obtain consent was adopted by
the Clinical Center, the research hospital of the National Institutes of Health, in
1953; by the Atomic Energy Commission in 1956; and by the Air Force in 1958.
In the 1960s, all branches of the Department of Defense promulgated regulations
requiring the consent of healthy subjects, and the Isotopes Distribution Division
of the AEC included in its guide for researchers a requirement of consent from all
subjects. In 1966, the surgeon general of the Public Health Service issued a
policy requiring the consent of all subjects of research conducted or funded by
PHS; also in the late 1960s, the Veterans Administration codified in its operating
manual a requirement of consent from all research subjects. In 1972, the National
Aeronautics and Space Administration adopted similar consent requirements,
although exceptions were made for certain subject populations, such as
astronauts. In 1974, the Public Health Service policy was promulgated as a
regulation for all contracts and grants of the Department of Health, Education,
and Welfare. The CIA did not formally adopt consent requirements until 1976,
when an executive order mandated that it follow the 1974 regulations of DHEW
concerning research involving human subjects.
general manager stated the AEC’s understanding that AEC contract researchers
4b. Research Involving Patient-Subjects: In an April 1947 letter, the AEC
would inform patient-subjects of the risks associated with a research intervention
and that patient-subjects express a willingness to receive the intervention. In a
second letter, written in November 1947, the general manager specifically
stipulated that the AEC require researchers to obtain “informed consent in
writing” from patient-subjects where “substances known to be or suspected of
being poisonous or harmhl” were given to human beings. In 1948, the AEC
permitted the administration of “larger doses [of radioisotopes] for investigative
purposes,” but only with the patient-subject’s consent. In 1953, the NIH Clinical
Center required consent from all patient-subjects and specified that written
consent was to be obtained from patient-subjects involved in high- or uncertainrisk
experiments. In the early 1960s, several government agencies adopted
consent provisions for investigational drugs; these requirements applied to some
radioisotope experiments with patients. In 1965, the AEC required that consent
be obtained fiom all subjects, including patient-subjects, who were administered
radioisotopes for experimental purposes, except when it appeared “not feasible”
or not in the patient’s “best interest.” By 1967, the VA required the consent of all
patient-subjects. As noted in Finding 4a above, in 1965 the AEC required that
consent be obtained from all subjects administered radioisotopes for experimental
or nonroutine uses. In 1966 the surgeon general of the Public Health Service
issued a policy requiring the consent of all subjects of research conducted or
funded by PHS, including patient-subjects. Exceptions to this requirement were
permitted for only certain kinds of social science research posing minimal risk. A
1972 NASA policy applied to all subjects of research, presumably including
patient-subjects. By 1973, all the branches of the military had promulgated
regulations requiring the consent of patient-subjects. In 1974, the PHS policy was
promulgated as a regulation for all contracts and grants of DHEW.
The Advisory Committee finds that government agencies did not
generally take effective measures to implement their requirements and
policies on consent to human radiation research.
Evidence of the implementation of the AEC’s consent requirements stated
in April and November 1947 letters from the general manager is slim. A
document suggests that the April 1947 requirement for a signed statement from
two physicians testifying to consent was satisfied in at least one case. However,
the Advisory Committee did not find evidence that this or other requirements
stated in the 1947 letters were embodied as a provision of AEC contracts
involving human subject research or otherwise routinely communicated to
contract researchers. Further, there was no reference to the requirements stated in
these letters or to the letters themselves in the written material disseminated to
researchers by the AEC’s program for distributing radioisotopes for “human uses.”
Moreover, requests for guidance concerning human use policies from
investigators at AEC-operated research facilities suggest that the 1947
requirements were not routinely disseminated. Subsequent requirements that
healthy subjects be informed volunteers and that consent be obtained from
seriously ill patients receiving higher doses of radioisotopes were more widely
communicated; we have not been able to determine the extent to which they were
detailing requirements for research with human subjects was rewritten as an
unclassified June 1953 directive from the secretary of the Army. It is difficult to
determine why these requirements were applied to some activities and not to
others. For example, elements of some of these requirements appear to have been
implemented in some experiments conducted in conjunction with atomic bomb
tests and not in others. In 1954, these requirements were adopted by the Army
surgeon general as applicable to all research involving “human volunteers.” This
1954 statement was transmitted to contractors as a “nonmandatory guide.”
However, there is some evidence that the Army sought to include this statement
as a condition in at least some contracts.
requiring that information be provided to and consent obtained from all subjects is
difficult to find; in most cases involving patient-subjects, documentation would
not have been required in writing. By contrast, the use of healthy subjects in the
Clinical Center required written consent and the “normal volunteer program”
appears to have involved greater supervision to ensure that consent was obtained
fiom these subjects.
Secretary of Defense Wilson’s February 1953 Top Secret memorandum
Evidence of implementation of the NIH Clinical Center’s 1953 policy
The Advisory Committee finds that from at least 1946 some
government agencies had in place procedural mechanisms for reviewing the
acceptability of risks to human subjects from exposure to radioisotopes. By
1974, the government had policies requiring review of the acceptability of
risks to human subjects in other forms of research, including research
involving exposure to external radiation.
Beginning in 1946 the Manhattan Project, and from 1947 onward the
AEC, required some investigators seeking to conduct experiments using
radioisotopes supplied by the government to have the risks to subjects reviewed
by a committee at the irlstitution where the work was to be conducted and in some
cases by the AEC’s Subbommittee on Human Applications as well. The AEC
required that local committees be composed of at least three physicians or
researchers with relevant expertise regarding radiation safety and medical
applications. By 1949, it was clear that this policy applied to all investigators
using radioisotopes supplied by the AEC.
In 1953 prior group review for risk was also begun at the NIH Clinical
Center for proposed human research that involved unusual hazard. No such
requirement applied to research funded by NIH but conducted at universities and
other nongovernmental research facilities until 1966, when the PHS required that
all institutions establish a local peer review committee to evaluate the adequacy of
the protection provided to human subjects in each proposal. This requirement
was promulgated as an institutional policy by the DHEW in 197 1.
In 1953, by adopting the Nuremberg Code, the secretary of defense and
the Department of the Army endorsed several principles intended to minimize risk
in research with human subjects, at least in regard to the atomic, biological, and
chemical warfare experiments that were subject to this policy. In the DOD, both
the purpose of proposed research and the level of risk were subjected to prior
review through the military chain of command. This was previously required by
the Navy at least from 1943, and the Air Force from 1952. However, the extent to
which these requirements covered particular research activities (such as healthy
subjects vs. patients; radioisotopes vs. external radiation) and particular
institutions (such as contractors vs. in-house research) differs and is difficult to
reconstruct. Also difficult to reconstruct is the extent to which the risk protection
principles of the Nuremberg Code were implemented. In the mid- 1960s,
concurrent with the adoption of regulations related to investigational drug testing,
the DOD and each military service adopted provisions requiring the establishment
of a “review board” or committee to oversee proposed research projects involving
new drugs. In some cases, such as with the Air Force beginning in 1965, this
committee also served to evaluate all other proposals involving human subjects.
During this period, the VA also established a review board mechanism for
research involving new drugs and investigational procedures.
The Advisory Committee finds that the government program of
distributing radioisotopes for use in human subject research included
procedures for the review of risk. These were widely implemented by
researchers and institutions that used isotopes obtained from the AEC for
human experimentation. However, there is no evidence that a parallel
mechanism for reviewing the risks of research involving external radiation
was in place.
From its 1947 birth, the AEC, as part of its policy to promote the peaceful
use of radioisotopes, required private institutions that wished to obtain
radioisotopes for “human uses” (including human experimentation as well as
patient treatment) to establish local review committees. These committees
reviewed proposed human uses under guidelines provided by the AEC’s own
Subcommittee on Human Applications of the Advisory Committee on Isotope
Distribution Policy. This AEC subcommittee reviewed these applications,
providing a second level of oversight of risk. By 1949, the AEC’s own labs were
required to establish local committees and to have human use applications,
reviewed by the same AEC Subcommittee on Human Applications. The control
of risk, and the assurance of safety to all those involved (including doctors and
other health care workers), was a primary purpose of the reviews. The Advisory
Committee lacked sufficient evidence to determine whether the system was
implemented in all of the many institutions that used government-supplied
radioisotopes for human subjects research or whether the system was always
adhered to in any particular institution.
In addition to providing for the review of research proposals, the AEC
dramatically increased the number of qualified personnel by offering training
courses in the safe handling and use of radioisotopes. As individual procedures
became routine, the degree of review was lessened; as specific institutions
became more experienced, more reviewing authority was delegated to them.
using radioisotopes, not to enforce any policies regarding consent of subjects.
(See chapter 6.)
The primary function of the system was to reduce the physical hazards of
The Committee finds that for the period 1944 to 1974 there is no
evidence that any government statement or policy on research involving
human subjects contained a provision permitting a waiver of consent
requirements for national security reasons.
Neither the AEC nor the DOD included national security exceptions in
their written rules on human subjects research. For example, the 1953 Wilson
memorandum adopting the Nuremberg Code was expressly applicable to human
experimentation related to atomic, biological, and chemical warfare and did not
provide for any “national security” exception.
The Committee notes that much documentation related to the CIA’S
program of secret experimentation, including MKULTRA, has long since been
destroyed, and, therefore, we cannot state with certainty what policy(ies) underlay
human experiments in these programs or whether such policies included national
9a. The Advisory Committee finds that government agencies had no
requirements or policies to ensure equity in the selection of subjects for
research conducted or funded by the federal government during the period
1944 through 1974.
The only reference during this period to issues of equity in the selection of
subjects in agency documents reviewed by the Advisory Committee is in an
influential DHEW guide to recipients of federal research finds published in I97 1,
popularly known as the Yellow Book. The Yellow Book notes a “particular
concern” about research involving “groups with limited civil freedom.”
9b. Because of the limited data available on the universe of
experiments identified by the Committee, the Committee was unable to
determine whether during the period 1944 through 1974 people who were
socially disadvantaged were more likely than more socially advantaged
people to be used as subjects in human radiation experiments generally or in
those experiments that offered no prospect of medical benefit or posed
greater risks. The Advisory Committee finds, however, that some of the
biomedical experiments reviewed by the Committee that were ethically
troubling were conducted on institutionalized children, seriously ill and
sometimes comatose patients, African-Americans, and prisoners.
The Committee has troubled by the selection of subjects in many of the
experiments we reviewed. These subjects often were drawn from relatively
powerless, easily exploited groups, and many of them were hospitalized patients.
As noted in Finding 9a, there were during this period no federal rules or policies
directed at fairness in the selection of research subjects, and no norms or practices
within the biomedical research community specifically addressing considerations
of fairness. This silence on questions of justice in the conduct of human research
was characteristic not only of radiation research but also of the entire research
enterprise. While we note here cases that provoked concern, we were unable to
determine the extent to which there were systemic injustices in the selection of
research subjects in human radiation research because in most cases we were
unable to determine any of the characteristics of the subjects involved in the
experiments we catalogued.
The Advisory Committee finds that even as early as 1944 it was
conventional for physicians and other biomedical scientists to obtain consent
from healthy subjects of research. By contrast, during the 1944-1974 period
but especially through the early 1960s, physicians engaged in clinical
research generally did not obtain consent from patient-subjects for whom the
research was intended to offer a prospect of medical benefit. Even where
there was no such prospect, it was common for physicians to conduct
research on patients without their consent. It also was common, however, for
physicians to be concerned about risk in conducting research on patientsubjects
and, in the absence of a prospect of offsetting medical benefit, to
restrict research uses of patients to what were considered low- or minimalrisk
Perhaps the best-known example of the use of informed volunteers in
research conducted at the turn of the century is the yellow fever research by
military scientist Walter Reed. In the Advisory Committee’s Ethics Oral History
Project, several of Reed’s military successors who were active in the 1940s and
1950s gave similar examples of voluntary consent from healthy subjects in the
context of work on typhus and malaria. In 1946, the American Medical
Association (AMA) articulated the principle that human subjects must give
“voluntary consent.” In 1947, the prosecution’s expert witness at the Nuremberg
Medical Trial, Dr. Andrew Ivy, who had helped shape the AMA principle in
conjunction with his role at Nuremberg, asserted that this was a standard by
which physicians were guided in the use of human beings in medical experiments
and that this standard was in “common practice” prior to its articulation by the
AMA in 1946. Precisely what Ivy meant by this claim is unclear. Although there
are doubtless instances in which this standard of voluntary consent was not
followed, it does seem to have been widely recognized and adhered to among
investigators whose research involved healthy subjects.
consent from patient-subjects. These sources include documents from the period
in which the conduct of clinical research was discussed as well as the
Committee’s Ethics Oral History Project, in which physicians active in research in
the 1940s and 1950s agreed that consent played little or no role in research with
patient-subjects, even where there was no expectation that the patient would
benefit medically from the research. At the same time, however, there was also
agreement that, where patients were used as subjects in nontherapeutic research,
the research usually posed little or no risk to the patients.
By contrast, various sources confirm that it was not conventional to obtain
1 la. The Advisory Committee finds that the government and
government officials are morally responsible in cases in which they did not
take effective measures to implement the government’s policies and
requirements, and the medical profession and biomedical scientists are
morally responsible for instances in which they failed to adhere to the
professional norms and practices of the time.
The Advisory Committee was concerned that our conclusions about
actions taken in the past be rendered fairly. Clearly, if government agencies had
rules or requirements for the use of human subjects at the time, and if these
requirements were sound from our point of view and consistent with basic moral
principles, then agencies and agency officials had just as much moral
responsibility to implement those requirements as those in analogous positions
would have today, or in any day, with respect to current sound government
requirements.’ We have found that some government agencies did in fact have
such requirements (see Findings 4 and 6).
had recognized norms and practices for the conduct of research with human
subjects, and if these norms and practices were sound, then physicianinvestigators
and other scientists operating in the past had just as much
responsibility to adhere to those norms and practices as those in analogous
positions would have today with respect to current noms and practices that are
morally sound. The Committee found evidence that the medical profession had
such norms with respect to obtaining consent from healthy subjects, although
physicians engaged in clinical research did not generally seek consent from
patient-subjects. The Committee also found evidence of professional norms
concerning acceptability of risk to subjects (see Finding 10).
Similarly, if the medical profession and the research community generally
llb. The Advisory Committee finds that by today’s standards we
consider it wrong that our government did not take effective measures to
adequately protect the rights and interests of all human subjects of research.
We also find that by today’s standards we consider it wrong that medical and
other professions engaged in human research did not have norms and
practices of consent for all subjects of research.
There is today a well-established consensus about the basic principles that
should!govern the use of human subjects of research. There is also wide
agreement that the government has an obligation to protect the rights and interests
of all human research subjects and that the medical and other professions engaged
in research are obligated to have norms and practices of consent for all human
subjects of research. The failure to have such conditions in place would today be
1 IC. The Advisory Committee finds that government officials and
investigators are blameworthy for not having had policies and practices in
place to protect the rights and interests of human subjects who were used in
research from which the subjects could not possibly derive medical benefits
(nontherapeutic research in the strict sense). By contrast, to the extent that
there was reason to believe that research might provide a direct medical
benefit to subjects, government officials and biomedical professionals are
less blameworthy for not having had such protections and practices.
significant risk, government oficials and investigators are more
blameworthy for not having had such protections and practices in place. By
contrast, to the extent that research was thought to pose little or no risk,
government officials and biomedical professionals are less blameworthy for
not having had such protections and practices.
We also find that, to the extent that research was thought to pose
Today we consider policies and practices to protect the rights and interests
of human subjects to be as important in research that offers participants a
prospect of medical benefit as in research that does not. Government regulations
and the rules of professional and research ethics apply equally to both kinds of
research. In the 1940s, 1950s, and 1960s, however, patients and society generally
accorded doctors more authority to make decisions for their patients than they do
today. It was both commonplace and considered appropriate for a physician to
determine what treatments a patient should receive without necessarily consulting
the patient, provided that the decision was based on the physician’s judgment
about what would be in the patient’s best interest. This authority generally
extended to decisions about whether a patient’s interest would be served by being
a subject in medical research. Judgments about the blameworthiness of officials
and physician-investigators for not having had policies and practices to protect
the rights of human subjects in research that offered a prospect of medical benefit,
such as requirements of consent, are mitigated by this historical context.
However, even at the time, government officials and biomedical
professionals should have recognized that when research offers no prospect of
medical benefit, whether subjects are healthy or sick, research should not proceed
without the person’s consent. It should have been recognized that despite the
significant decision-making authority ceded to the physician within the doctorpatient
relationship, this authority did not extend to procedures conducted solely
to advance science without a prospect of offsetting benefit to the person. This
finding is supported by the moral principle, deeply embedded in the American
experience, that individuals may not be used as mere means toward the ends of
others. We also note that at its 1947 beginning, officials of and biomedical
advisers to the AEC were clearly aware of the issues raised when patients, as well
as healthy people, were used as subjects in nontherapeutic research without their
The Advisory Committee has also determined that government officials
and scientific investigators at the time recognized that research could put subjects
at risk of harm, that they had an obligation to determine that the risks imposed
were reasonable, and that research that posed greater or more uncertain risks was
more problematic than research whose risks were lower. Sometimes government
officials and investigators took steps to protect subjects from unnecessary or
unacceptable risks. These steps included in some cases a requirement of group
review of research proposals and the obtaining of consent of the subjects,
particularly where risks were considered worrisome. But these steps were not
consistently or uniformly taken.
The Advisory Committee finds that some service personnel were used
in human experiments in connection with tests of atomic bombs. The
Committee finds that such personnel were typically exposed to no greater
risks than the far greater number of service personnel engaged in similar
activities for training or other purposes. The Committee further finds that
there is little evidence that the 1953 secretary of defense Nuremberg Code
memorandum was transmitted to those involved with human experiments
conducted in conjunction with atomic testing. However, some of the
requirements contained in the memorandum were implemented in the case
of a few experiments, apparently independently of the memorandum. The
Committee also finds that the government did not create or maintain
adequate records for both experimental and nonexperimental participants.
More than 200,000 service personnel participated in nuclear weapons tests
from 1946 to the early 1960s. The vast majority of those who participated were
engaged in management of the tests, training maneuvers, or data-gathering
activities. In the range of 2,000 to 3,000 of these participants were research
subjects. In many cases these research subjects engaged in activities, and were
subjected to risks, essentially identical to those engaged in by many more people
who were not research subjects. The purpose of this human subject research was
not to measure the biological effects of radiation. Rather, for example,
researchers sought to measure the psychological and physiological effects of
participation in bomb tests, the levels of radiation to which individuals who flew
in and around atomic clouds were exposed, and the effects of intense light from
the bomb blast on the eyes.
memorandum on human experimentation in connection with atomic, biological,
The Advisory Committee found little evidence that the 1953 Wilson
and chemical warfare (or an Army implementing document) was transmitted to
those involved in bomb-test-related experimentation. In interviews with
Committee staff, some of those involved in the experimentation stated that they
were unaware of the memorandum. However, there is evidence that in some of
the experiments consent was provided for, but this was likely independent of the
levels that were likely to produce acute effects. However, bomb-test participants
were exposed to lower levels of radiation, which might conceivably have effects
on some participants over the longer term. The evidence shows that those who
managed the tests were aware of the potential, however small, that injury might
result years later from such exposures. In recent years, as the government and
veterans have sought to reconstruct the extent of exposure and resulting injury, it
has become apparent that the government did not uniformly create records that
would permit all individuals to efficiently and confidently know the extent of
their exposure, did not create records that would permit reconstruction of the
identity and location of all those who participated at the tests, did not adequately
undertake to link medical and exposure records, and did not adequately maintain
those records that were initially created.
The military took successfbl precautions against exposure to radiation
The Advisory Committee finds that during the 1944-1974 period the
government intentionally released radiation into the environment for
research purposes on several hundred occasions. In only a very few of these
cases was radiation released for the purpose of studying its effect on humans.
The Advisory Committee’s charter identified thirteen releases: one related
to the testing of intelligence equipment (the “Green Run”), eight radiological
warfare tests, and four releases of radioactive lanthanum (“RaLa”) to test the
mechanism of the atomic bomb. The Advisory Committee received information
on more than sixty radiological warfare releases that took place in the period
1949- 1952 and on the nearly 250 RaLa releases that took place in the period
1944- 196 1. We identified further intentional releases of a kind that were not
described in the charter. These included the release of radiation to study its
environmental pathways and the release of radiation in connection with outdoor
safety tests and tests related to the development of nuclear reactors, as well as to
the development of nuclear-powered rockets and airplanes.
Most releases took place in and around the sites that constitute the nation’s
nuclear weapons complex, notably Oak Ridge, Tennessee; Hanford, Washington;
Los Alamos, New Mexico; the Nevada nuclear weapons test site; and the Idaho
National Engineering Laboratory. Releases related to radiological warfare tests
took place primarily at the Dugway Proving Ground in Utah. Radioactive material
was also released into the environment for research purposes at other locations;
for example, fallout from the Nevada Test Site was inserted into the tundra of
The Advisory Committee finds that for both the Green Run (at
Hanford) and the RaLa tests (at Los Alamos), where dose reconstructions
have been undertaken, it is unlikely that members of the public were
directly harmed solely as a consequence of these tests.
It is impossible to distinguish any harm due to these releases from other
sources of exposure, particularly at Hanford, where the amount of radioactivity
intentionally released by the Green Run was 1 percent of the amounts released by
routine operations of the Hanford facility in the 1945- 1947 period. The risks of
thyroid disease from all past operations of the Hanford plant are currently under
study; however, the Advisory Committee estimates that the contribution of the
Green Run to any such risks amounts to substantially less than one case. No dose
reconstruction has been undertaken for the radiological warfare field tests at the
Dugway Proving Grounds. Most of the intentional releases the Advisory
Committee has studied, including all those identified in our charter, involved
radioactive materials with short-enough half-lives that they quickly decayed and
therefore pose no risk to health from continuing exposure.
The Advisory Committee finds that during the period from 1944 to
about 1970 there was no system of environmental laws and regulations
governing the conduct of intentional releases analogous to that currently in
place. However, those responsible for intentional releases during this period
recognized the possible health risks from environmental releases and that
risks had to be considered in making policy decisions about such releases.
In the case of the Green Run, guidelines existed for routine (or normal
operating) environmental releases of radioactive iodine but were exceeded; in the
case of radiological warfare tests, a safety panel was created. These and other
releases specified in the Advisory Committee’s charter were conducted in secret
because of a combination of concerns about national security and public reaction.
The Atomic Energy Act of 1954 began the formal public system of safety
regulation of environmental releases of radiation. It was not until the National
Environmental Policy Act of 1969 that public review of federal actions likely to
have a significant impact on the environment was institutionalized.
The Committee finds that, as a consequence of exposure to radon and
its daughter products in underground uranium mines, at least several
hundred miners died of lung cancer and surviving miners remain at elevated
risk. As a consequence of a U.S. hydrogen bomb test conducted in 1954,
several hundred residents of the Marshall Islands and the crew of a Japanese
fishing boat developed acute radiation effects. Some of the Marshall
Islanders subsequently developed benign thyroid disorders and thyroid
cancer as a result of the radiation exposure. Surviving Marshallese also may
remain at elevated risk of thyroid abnormalities.
The miners, who were the subject of government study as they mined
uranium for use in weapons manufacturing, were subject to radon exposures well
in excess of levels known to be hazardous. The government failed to act to
require the reduction of the hazard by ventilating the mines, and it failed to
adequately warn the miners of the hazard to which they were being exposed, even
though such actions would likely have posed no threat to the national security.
Some Marshallese exposed during the 1954 bomb test received radiation
doses substantially in excess of those considered safe, both at the time and today.
One Marshallese exposed as a baby died of leukemia in 1972, which may have
been as a consequence of exposure during the test. In 1954, twenty-eight U.S.
servicemen manning a weather station on Rongerik Atoll also received doses of
radiation substantially in excess of those considered safe at the time and today.
The Advisory Committee does not know whether any of the servicemen suffered
long-term harm as a result of their exposure. Twenty-three Japanese fishermen
were irradiated as a result of the fallout from the 1954 bomb test. The exposed
Marshallese population received additional doses of radiation from later bomb
tests and residual radiation in the food chain, which continues to this day. The
U.S. government–initially the Navy and then the AEC and its successor agencies–
has provided care to the Marshallese ever since for radiation-related illnesses
while conducting research on this population to determine radiation effects. For
many years the distinction between research and clinical care was not adequately
explained to the Marshallese.
The Committee finds that since the end of the Manhattan Project in
1946 human radiation experiments (even where expressly conducted for
military purposes) have typically not been classified as secret by the
government. Nonetheless, important discussions of human experimentation
took place in secret, and information was kept secret out of concern for
embarrassment to the government, potential legal liability, and concern that
public misunderstanding would jeopardize government programs. In some
cases, deception was employed. In the case of the plutonium injection
experiments, government officials and government-sponsored researchers
continued to keep information secret from the subjects of several human
radiation experiments and their families, including the fact that they had
been used as subjects of such research. Some information about the
plutonium injections, including documentation showing that data on these
and related human experiments were kept secret out of concern for
embarrassment and legal liability, was declassified and made public only
during the life of the Advisory Committee.
Human experimentation conducted during the Manhattan Project was
carried out in secret. Since 1947 (when the Atomic Energy Commission began
operations and the military services were unified under a secretary of defense)
human radiation experiments have rarely been protected as classified secrets.
be kept secret only where required by national security. At the same time, AEC
officials and advisers secretly determined that reports on human radiation
experiments should not be declassified where they contained information that was
potentially embarrassing or a cause of legal liability. Upon requests for
declassification, research reports involving human radiation experiments and
other human radiation exposures were reviewed for their effects on public
relations, labor relations, and potential legal claims.
subject research policy; some of these discussions were conducted in secret
meetings, and the statements of requirements that were articulated, while not
secret, evidently were little disseminated. Similarly, 1949- 1950 AEC/DOD
discussions of the terms on which human radiation experiments could be
conducted were either secret or the substance of the discussions was given limited
public distribution. In 1952, Department of Defense biomedical advisory groups
also engaged in secret or restricted discussions of policy, which led to the 1953
issuance of the Wilson memorandum, which was itself issued in Top Secret.
Government officials and experts did not squarely and publicly address
the existence and scope of government-supported human radiation
experimentation. For example, in the late 1940s and early 1950s the AEC denied
to the press and citizens that it engaged in human experimentation, even though
In 1947 AEC biomedical advisers publicly urged that biomedical research
, In 1947 AEC officials and advisers conducted discussions about human
the AEC’s highly visible radioisotope distribution program had been created to
provide the means for, among other things, human experimentation.
Project Sunshine, a worldwide program of data gathering, including
human data gathering to measure the effects of fallout, was kept secret from its
1953 inception until 1956, and AEC officials and researchers employed deception
in the solicitation of bones of deceased babies from intermediaries with access to
human remains. It appears that concern for public relations played a key role in
keeping the human data gathering, and the very existence of Project Sunshine,
All the intentional releases identified in the Advisory Committee’s
charter, as well as the several hundred other releases that were essentially of
the same types, were conducted in secret and remained secret for many years
thereafter. All involved some stated national security purpose, which may
have justified some degree of secrecy. Despite continued requests from the
public that stretch back well over a decade, however, some information
about intentional releases was declassified and made publicly available only
during the life of the Advisory Committee.
The Committee’s review indicates that internal proposals that the public be
informed about the existence of the radiological warfare program were rebuffed
on grounds that public misunderstanding might jeopardize the program.
Citizens learned of the 1949 Green Run in 1986, and then only following
close review of documents requested from the government by members of the
public. Portions of a key surviving report on the Green Run were not declassified
until 1994. Similarly, although 250 intentional releases near the land of the
Pueblo Indians in New Mexico took place between 1944 and 196 1, the Pueblo do
not appear to have been informed of the full scope of the program until 1994.
Documentation on these midcentury tests is only now being declassified.
The Advisory Committee finds that the government did not routinely
undertake to create records needed to ensure that secret programs could be
understood and accounted for in later years and that it did not adequately
maintain such records where they were created. The Committee further
finds that many important record collections (including records that were
not initially classified) have been maintained in a manner that renders them
practically inaccessible to those who need them, thereby limiting the utility of
the records to the government itself, as well as the public’s rights under the
Freedom of Information Act.
Where citizens are exposed to potential hazards for collective benefit, the
government bears a burden of collecting data needed to measure risk, of
maintaining records, and of providing the information to affected citizens and the
public on a timely basis. The need to provide for ultimate public accounting, as
was recognized by early AEC leadership, is particularly great where risk taking
occurs in agencies that do much of their work in secret. The government did not
routinely or adequately create and maintain such records for relevant human
radiation experiments, intentional releases, and service personnel exposed in
conjunction with atomic bomb tests.
or destroyed over the years. These include the classified records of the Atomic
Energy Commission’s Intelligence Division; secret records that were kept in
anticipation of potential liability claims from service personnel exposed to
radiation;2 records relating to the secret program of experimentation conducted by
the CIA (MKULTRA); nonclassified records of VA hospitals regarding the
thousands of experiments that, the VA told the Advisory Committee, were
conducted there; and nonclassified files of the AEC’s Isotope Distribution
Program relating to the many licenses for “human use” it granted in the period
1947 to 1955. The Committee notes that laws governing government records
provide for routine destruction of older records; however, we also found that
some records documenting the destruction of records had been lost or destroyed.
Committee about the credibility of the government’s efforts to respond to requests
for documents. The Advisory Committee’s experience indicates that
shortcomings in government response to Freedom of Information Act requests,
which may be interpreted by citizens as deliberate nondisclosure, may often occur
because the agencies themselves lack adequate road maps to the records that still
exist and lack records needed to determine whether collections of importance to
the public have been lost or destroyed. In the absence of the efforts put forth by
the Human Radiation Interagency Working Group, thousands of documents that
have now been made public would not have been located.
Where records were initially created, important collections have been lost
Public witnesses and others repeatedly expressed doubt to the Advisory
A PROBLEM REGARDING ACHRE FINDING THREE:
The Advisory Committee finds that human radiation experimentation
during the period 1944 through 1974 contributed significantly to advances in
medicine and thus to the health of the public.”
The era of medical experimentation using radioisotopes and external radiation did not commence in 1944. It commenced very early in the 20th (one of the earliest
Experimental treatments being the use of removable radium needles, as suggested by Alexander Graham Bell in around 1901).
By the early 1930s, Drs John Lawrence, Erf, and Hamilton in particular had begun using radioactive isotopes (initially Iodine 131, later Phosphorous 32) injected into patients as experimental treatments.
By the late thirties and early 1940s, Drs Pecher had begun treating terminally ill patients suffering bone cancer with injected Radio Strontium 89. In the same period Dr Stone had, for a short time, treated patients with neutron rays. (This halted due to late emergence of horrifying effects not initially anticipated (Scott). The problems halted the use of neutron ray treatment until the late 1960s (first later use being in England.)
Several things come out of this. Despite President Clinton setting a time span limit of 1944 to 1974 on the ACHRE committee study, it is clear that Iodine 131, Phosphorous 32, Strontium 89 and neutron rays all were found by the Manhattan Project, from 1942 onward to all be sources of ionizing radiation generated by the detonation of atomic bombs. P32 being a neutron radiation activation product which causes late effects which are extremely distressing and often fatal. (Scott, UC Berkeley Oral History Project, also US Special Weapons Unit publications).
At what point President Roosevelt’s Uranium Committee (later S1) became aware of the link between the human medical knowledge base of effects of these 4 early experimental treatments on humans is not known for certain. However, it is reasonable to state that Ernest Lawrence was fully conversant with them. The Lawrence archives show Ernest Lawrence received update reports on all of them throughout the 30s and 40s. The trials with these substances and neutron radiation took place at Lawrence’s “Crocker Radiation Lab”, located at the time at UC Berkeley. Ernest Lawrence was a member of the Uranium Committee by May 1941.
Though the question of consent in relation to exposures to substances and radiations known to be dual by 1944 for certain does not apply to the early work. Patients were carefully screened and the concept of dual use (military/medical) did not compromise the gaining of patient consent. Notable successes were gained by using Sr89, I131 and P32 to treat painful conditions. Pain relief in the era was crude and there is no doubt dying people received beneficial pain relief by the use of Strontium 89 injections. Neutron therapy was a painful failure and was quickly curtailed. A problem arises however.
Given the success from 1939 of Pecher’s Sr89 injection in controlling the pain suffered by people suffering terminal bone cancer, why was his treatment not used more widely in the immediate period following World War 2?
It is obvious why Drs Stone, Hamilton and Lawrence played such prominent roles in the bio medical activities of the Manhattan Project. Dr Pecher may well have taken the place of Hamilton have Pecher passed August 1941. (I imply nothing sinister in the death of Dr Pecher, I merely record the fact).
Why was it that the pre war world of Hamilton with I131 did not prevent its wide spread use as a treatment after the war? Why was Pecher’s work labeled secret by the Manhattan Project and the Atomic Energy Commission?
What distinquishes Radio Strontium from Radio Iodine?
Project Sunshine. It was pursuit to the global bone radio strontium uptake survey known as Project Sunshine that Pecher’s work, despite its limited pre war publication, was classified secret.
The record shows John Lawrence continued Pecher’s trials during the 1950s. And despite doctors, notably Dr Low-Beer, confirming the superiority of the treatment compared to the P32 treatment, the AEC distributed only P32 for use in nuclear medicine. History shows that the Pecher treatment received FDA approval for medical use in 1993. That is, for the entire period of Project Sunshine, the data sheet on a major fission fallout product was not available because the Sr89 treatment was not available. From 1954 the AEC disclosed much about Sr90, strontium 90, in fallout. Sr89, a more potent fallout product, was rarely, if ever mentioned in public.
It appears then, that from 1945 to 1993 the American people were denied Pecher’s Sr89 treatment simply because it was dual use, and a technical understanding of it, as disclosed by its radio-pharmacological data sheet, would enter the loaded environment of the era of atmospheric nuclear weapons testing and the fallout debate.
For whatever reason however, history shows first use of the Sr89 in 1939, and approval for open use in 1993 in the USA.
This amounts to a delay in implementation of 54 years. There is strong reason to suggest that 1. The Manhattan Project and then the AEC were in the periods the sole distributors of radioisotopes for medical use. 2. They were bomb use and bomb safety authorities. It was first learnt that Sr89 was a fission product in 1941.
What then is the basis for the ACHRE finding that:
The Advisory Committee finds that human radiation experimentation
during the period 1944 through 1974 contributed significantly to advances in
medicine and thus to the health of the public.” (Achre report, Findings).
This finding does not hold true for a significant dual use radioisotope. Those victims of the British nuclear tests should note the precedent which the US set in relation to the violation of human subjects and human tissue. I am thinking to earlier contributions related to BNFL and the secret dismemberment of Sellafield (Windscale) workers.
Early in the Final Report, the ACHRE personnel commented that: “Research involving human subjects continues to be essential to the progress of medical science, since most advances in medicine must at some point in their development be tested in human subjects.” (see above). In the case of Strontium 89 as a treatment, from 1939 to 1941 (published 1942, Pecher, posthumous.) and throughout the later 40s and 1950s, the Pecher trials were overseen by John Lawrence. Dozens of people were treated within the confines of first, the Manhattan Project (at Berkeley) and later, under the AEC at Berkeley and Chicago. The trials then halted. The treatment appears with held, and not until foreign “rediscovery”(1973, Dr. Firusian, Germany) and success with the Sr89 treatment resulted finally in widespread availability of the treatment throughout the US and consequently the rest of the developed world. (Canada, following Firusian’s lead, approved the treatment in the 1980s (Source: General Electric nuclear medicine website.)
A delay in introducing a new treatment of over 50 years applies to Sr89 Chloride as a treatment for the severe and chronic pain suffered by people battling terminal secondary bone cancer. This delay makes a mockery of the statement above, for thousands of Americans, primarily victims of breast and prostate cancers (spread to bone), suffered with the lack of the treatment and who therefore suffered less choice, and, according to many modern medical surveys, what might be the inferior treatment of P32. I show below that modern medical research is at variance with Lawrence’s 1950s assurance that P32 produces less bone marrow damage than does, he claimed, Sr89. Modern research finds the opposite. As such every medical study of Sr89 compared to P32 as a treatment agrees with the report of Pecher in this respect (published 1942). Why then did Lawrence find to the contrary in the 50s and why did the AEC fail to provide Sr89 (and the required datasheet) to the American public as a treatment option? Was it because any technical knowledge held in the open on Radio Strontium conflicted with the aims of the AEC in the era of controversy over radio strontium as a fallout product and a primary plank of the anti bomb movement? Both Sr89 and Sr90 are bomb fallout components, Sr89 being the most potent and radioactive in the short term. At the end of this post I submit a summary of the military knowledge of the effects of Sr89, held from 1942 on, and the medical knowledge of the substance. From it, I find the ACHRE report inadequate as a response. The with holding of this treatment is not justified by its findings, and as a result of the disclosures history provides, renders the ACHRE Final overly optimistic and the pathway for a program of rehabilitation of the nuclear authorities, a process which those authorities seem to have commenced as soon as Clinton left office. One of Clinton’s last acts in this respect was to authorize an open tender for the conduct of experiments aimed at demonstrating what harms may have been suffered by Americans down wind of nuclear test sites in the USA. Flinders University, South Australia won the contract and the rehabilitation of low radiation exposure by Bobby Scott, Lovelace Institute, New Mexico, citing Sykes, South Australia, has now been underway for a number of years.
The method of rehabilitation has been via the theory of radiation hormesis as promoted in the 1950s by Marshall Brucer then of Oak Ridge. The supposed proof has been the response of unique and genetically identical mice, specially bred by which a mechanism of repair, stimulated by low dose radiation, is claimed to apply to humans and which in humans never fails for any reason. This myth provides the basis for the rehab of authorities and the isolation of victims. Many things follow from this. Scott proposes the deliberate exposure of the mass of the public to low level radiation. Not without informed consent, Bobby.
I further present the following with sources (please note the datasheet on the carcinogenic nature of the treatment, which is also a fission fallout product and a product vented in the normal operation of nuclear reactors. The test rats mentioned in the datasheet obviously lacked the abilities of Flinders Universities mice, deployed in the service of the US DOE):
A Medical Rediscovery but a Military Constant
In 1973 Dr Firusian et. al. in Germany rekindled interest in Pecher’s 1939 Strontium 89 cancer treatment by reporting his success with it as a treatment. Firusian reported outcomes in pain relief in a German language journal. Publication of the results in English by Firusian et. al. occurred in 1974. 
The doctors cite the 1939 -1941 work of Pecher as the basis for their 1970’s Sr 89 treatment trial. The intervening years are described as a period of “relative obscurity” for Charles Pecher’s Sr89 treatment. 
However, within the US nuclear weapons establishment at the same time, those same “obscure” papers had constantly formed the basis a military knowledge of the radiological and biochemical nature of the fission product Strontium 89 since the days of the Uranium Committee in 1941. The Pechers had not been forgotten by the
weaponeers. For example, the report by J. G. Hamilton, “Metabolism of Fission Products, Progress Report for Period Ending April 15, 1944”, Argonne National Laboratory, under the authority of the Manhattan Project, carries on and extends dietary experiments involving radio strontium, calcium and rats. The originally classified “Lawrence Berkeley National Laboratory, (University of Calif.) Monthly Progress Report No.59 for March 1948” states on page 9: “Comparative studies using radio calcium and radio strontium have been set up…” The activities closely resemble work carried out by Charles Pecher. The military record is a perversion of the Pechers’ nutritional and nuclear medicine. The military record is replete with secret references to the Pecher’s published medical and nutritional work.
In an AEC internal memorandum date February 1, 1954, John C. Bugher requests “all the information that can possibly be developed on the people who were given Strontium 89 in the early 40’s in California….Some of this was published by Dr. Pecher…” “This study should be given very high priority, and whatever effort is necessary should be devoted to it.” In July 1954 the “Report on Project Gabriel” had been completed. This secret report included detailed references to the work of Charles Pecher in regard to radio strontium in milk, the transport of radio strontium from mother to offspring, and the administration of Sr89 to human patients as a treatment for secondary, terminal, bone cancer as reported in 1942.
In the 1950s the Atomic Energy Commission ordered the editors of Scientific American to burn an entire monthly issue of that journal: “Referring to the burning of most of the editions of a recent issue of the magazine “Scientific American”, at the request of the Atomic Energy Commission, the Council maintained that no one among scores of reputable readers had found any appreciable volume of information which should have been kept secret. “It was not secrets which were thus protected,” the Council’s statement said, “it was the raw material for public understanding which went up in smoke.”  There are more subtle methods of controlling knowledge than burning scientific journals. While the burning of the Scientific American was related to technology and not the health physics of fallout, it is a clear example of generic information control applied at the time.
The military lineage is clear, constant and was secret. Pecher’s knowledge remained familiar to relevant compartments of the Manhattan Project, Project Gabriel and Project Sunshine, which wound down in the mid 1970s. The medical line however is relatively obscure; the pain relief treatment originated by Pecher fell into disuse from 1950.And even then the 50s use was confined to spheres of research confined to the AEC and largely overseen by Pecher’s 1930s mentor, Lawrence.
I can find no post 1976 medical paper that agrees with John Lawrence’s 1950 statement “it seems unlikely that radio strontium will be a valuable therapeutic treatment”. The AEC funded the Lawrence paper which wrote off the Sr89 treatment.
Lawrence also writes that Sr89 is more damaging to the marrow than Phosphorous 32, his treatment of choice. The post 1976 medical reports we have found state clearly that Sr89 is less damaging to the marrow than P32. Pecher found Sr89 superior to P32 as a treatment partly for this reason in 1941. 
Today the search continues for superior treatments. The use of Sr89 and P32 in medicine is now probably free of the horrible constraints it seems were imposed prior to Dr Firusian’s rediscovery of Sr89 as a treatment and his testing of the pre war record. This resulted in a new era of Sr89 treatment trials which culminated in the 1993 US FDA approval  of the Sr89 treatment within the parameters of use anticipated by Charles Pecher and Ernest Lawrence in 1941.  That is, for the palliative reduction of pain from secondary cancer of bone. Once he was in the pay of the AEC, John Lawrence appears to have changed his mind about the use of the Pecher treatment, a treatment which, from 1939 to 1942 he advocated and praised on technical and medical grounds.
It is my view that from 1950 on the AEC felt secure in the knowledge that Sr89 was not used as a treatment beyond the (by then extended) John Lawrence cohort. In 1954 it would not do to have Sr89 dosimetry described in public medical safety data sheets and prescription guides for these would have described the immediate effects of Radio Strontium both as a medicine and as a fallout product. Exposure to it was only ever advocated by Pecher in the pursuit of treating an extremely painful and fatal form of cancer. it was to be kept away from the healthy and from pregnant women. This was Precher’s view until his death in 1941.
A section of the current General Electric description of its Sr89 radio pharmaceutical, “Metastron” Strontium 89 Chloride (the injectable form), is included at the end of this article. Had this document been released in public in 1950 the AEC, I submit, would have engaged in a fair amount of journal burning. In such a loaded setting, the Lawrence 1950 assessment of the Strontium 89 treatment is unlikely to have had a purely technical and medical basis. Such organisational cultural and political pressure affect perceptions.
The Breach in the History of Medicine -A Brief Comparison of Papers
“A 65 year old patient with osteoblastic metastases was given8MCi (Sr89) lactate in 3 doses: Sep. 1940 and Dec.1940, and in Jan. 1941. His pain disappeared almost immediately and general condition improved remarkably.” –Charles Pecher, 1941. 
“It seems unlikely that radio strontium will be a valuable therapeutic agent”: -Lawrence, J. H., Wasserman. 
“A significant clinical improvement could be observed in 8 of the 11 patients with generalized osseous metastases of prostatic carcinoma after the application of 30 muCi. 89 strontium per kg. The effect was long lasting.” : Firusian N et. al. and Firusian N, Mellin P, Schmidt CG. 
“In 1950, Lawrence and Wasserman treated 11 multiple myeloma patients with 32P and nine patients with a combination of 32P and 89Sr. Although 5 of the 20 patientshad a response to treatment as measured by improved pain control, they concluded that there was no evidence that the combination of 89Sr and32P proved more effective than32P alone, they further concluded that it was unlikely that radio strontium will be a valuable therapeutic agent.” “This (current) report describes a patient with severe rib pain due to multiple myeloma whose chest radiograph showed multiple lucent lesions throughout the bones of the chest wall but whose bone scan showed marked osteoblastic activity. The patient was treated with 89 Sr and received substantial pain relief. ” “Strontium-89 is an effective agent for the palliation of bone pain from osseous metastasis from breast and prostate cancer with an overall response rate reported in the range of 60% -80%.” Edwards, K., et. al. 
“He (Pecher) would have been gratified to see the current clinical results fromMetastron (89SrCl2) for pain relief from skeletal metastases from carcinoma of the prostate.” V. Ralph McCready 
President Clinton’s Advisory Committee on Human Radiation Experiments Final Report claims that the conduct of nuclear medicine, under the control of both the military and then the Atomic Energy Commission from 1944 to the 1970s, “advanced biomedical science.”  This statement is clearly untrue in relation to the Strontium89 palliative pain control treatment originated by the Pechers in the period 1939 –1941.
Extract from the General Electric Data Sheet for Metastron, Strontium 89 Chloride:
“Carcinogenesis, Mutagenesis, Impairment of Fertility
Data from a repetitive dose animal study suggests that Strontium-89 Chloride is a
Thirty-three of 40 rats injected with Strontium-89 Chloride in ten consecutivemonthly doses of either 250 or 350 µCi/kg developed malignant bone tumors after a latency period of approximately 9 months. No neoplasia was observed in the control animals.
Treatment with Strontium-89 Chloride should be restricted to patients with welldocumented metastatic bone disease.
Adequate studies with Strontium-89 Chloride have not been performed to evaluate mutagenic potential or effects on fertility.
Pregnancy: Teratogenic effects.Pregnancy Category D. See Warnings section.
Because Strontium acts as a calcium analog, secretion of Strontium-89 Chloride into human milk is likely. It is recommended that nursing be discontinued by mothers about to receive intravenous Strontium-89 Chloride. It is not known whether this drug is excreted in human milk.
Safety and effectiveness in pediatric patients below the age of 18 years have not been established.” End quote.
Summary and Conclusion
The published work of Charles and Jacqueline Pecher establishes that a crucial knowledge base relating to nutrition and medicine in regard to the fission isotopes of strontium pre existed the use of nuclear weapons.
In 1925 disease and death caused by the incorporation of Radium into bone was described by medicine. The delivery of radioactive substances of biochemical activity to target populations by military means may have been conceptualized at that time.
I conclude that Charles Pecher was assigned to obscurity by secrecy imposed with the advent of nuclear weapons. His work, to which his wife, Jacqueline, contributed, became obscure also outside of the military and industrial nuclear complex.
Charles Pecher found strontium uptake is related to calcium in the diet. This forewarned authorities. I conclude this knowledge was seen as a strategic advantage by the Western Alliance in relation to “enemy” cultures such as Germany, Japan the Soviet Union at the relevant times in history.
The concept of the biological assimilation of the fission product Radio Strontium via its transport through the calcium pathways is predicted by the Pechers’ findings. The military application is a perversion of the purpose which originally motivated the research. Had Charles Pecher not possessed his strontium knowledge in August 1941, the scientific, political, international and moral binds which caused his death may not have existed.
The Canadian Coronial findings describe the means of his death, but not the motivation. There are no declared witnesses to the death of Charles Pecher. His death occurred some time after he went missing while under Belgian military control. His body was found some days later by chance, by fishermen, not a military search party. Immediately prior to this he had been hospitalized under Belgian military authority. The drugs which caused his death may have been prescribed to him during his hospitalization. The cause of death is given by Canadian authorities as suicide.
Given the lack of witnesses and the fact that Charles was “missing” immediately prior to his death, this finding is circumstantial. The Belgian government instigated a cover up and individuals in the United States cooperated in this cover up. No-one has documented who, if anyone, met him, influenced him or acted against him during the three days unaccounted for. His wife was 7 months pregnant with their first child at the time.
Charles Pecher’s determination of the role of vitamin D in the uptake and mineralization of calcium – and strontium -appears to be have inspired the later naming of the US strontium fallout, deposition and uptake targeting survey – Project Sunshine. The name is a perverse wink and nod.
Knowledge existed which forewarned of differential uptake of radio strontium according to dietary variables and therefore differing cultures. The health effects of atomic weapons testing would not be uniform across nations comprised of multiple cultures and therefore multiple diets. The differences between the Anglo Saxon and Soviet diets may have enabled a crude targeting by way of enhanced harms inflicted upon the enemy of the day. The vulnerable diet is the calcium dilute diet. This expressed as the Ca/Sr ratio.
The diet used as the baseline for strontium uptake studies and the diet most subject to calcium boosting during the era of atmospheric atomic testing was that diet described in 1954 as the “American” diet. It excluded Native Americans. The same core diet is described as the “English” diet by Comar (1962). In the test era Australia boosted the calcium content of the culturally dominant diet. Specific acts against the Indigenous diet can be identified in the historical record. One such act was the reduction of land access permitted to Aboriginal people concurrent with the atomic tests. Another was the refusal by the Federal Government to provide money for the purposes of reducing Aboriginal malnutrition evident in the Western Australian Central Aboriginal Reserve. (Letter, W. L, Grayden to Minister of Supply, Beale, and reply, 1957).
Trials of Charles Pecher’s Strontium 89 palliative cancer treatment continued after his death. The trials took place in a loaded political and research environment. Public debate and public disclosure of information relating to radio strontium was controlled. The widespread use of Sr89 as a radiopharmaceutical would have resulted in widespread publication of the radio-biological nature of the fission fallout radionuclide. This would have made the knowledge available to ordinary voters.
Medical data specifically relating to the Sr89 medical treatment was classified secret in 1954 and possibly earlier. Lawrence and Wasserman, both AEC employees, in 1950 reported that Sr89 was unlikely to be of value as a treatment. Reports since 1974 disagree with the 1950 AEC assessment. The post 1974 papers report that Sr89 is less damaging to marrow than Phosphorous 32. Lawrence and Wasserman had reported the opposite in 1950. The modern papers agree with the 1941 findings of Charles Pecher and Ernest O. Lawrence in these matters. The delay in the use of Sr89 either resulted from multiple errors and inadequacies on the part of AEC medical researchers, including John Lawrence, or from political pressures present within the AEC in 1950, or both. At the time the AEC was the sole supplier of radioisotopes for medicine in the United States. It controlled production by using highly secure nuclear reactors for the production of radiopharmaceuticals over the pre war method of cyclotron production.
People died in greater pain from secondary bone cancer in the period 1950 – 1993 as a result of the actions of the AEC than would otherwise have been the case. The AEC retarded the progress of nuclear medicine.
The AEC spent millions of dollars undertaking Strontium 90 injection studies of Beagles and Chimps throughout the period of Project Sunshine and announced that the results showed the public was safe at the doses the typical American recieved. It did not publish the Sr89 results. This was left to the current General Electric data sheet quoted above. 33 out 40 healthy rats were apparently very unlucky when injected with Sr89. The medical and patient datasheets for Strontium 89 did not exist until 1993. They should have existed from 1949 at the latest, allowing for a ten year research period.
A confluence of events occurred in the period Charles Pecher conducted their strontium research at the Lawrence Crocker Laboratory at Berkeley. Under the pressure of war in Europe, the United States examined the possibilities of radiological warfare. In 1941 the National Academy of Science recommended that radiological weapons utilizing radioactive strontium be given a higher a priority than the atomic bomb. Charles Pecher killed himself in August of that year. The knowledge base he created gave foresight to authorities into the effects of a major fission product dispersed over populations by possible radiological dispersal weapons, by the detonation of nuclear weapons and by any fission process that vents fission products into the biosphere. The decline of the cyclotron and the rise of the nuclear reactor will be the focus of a future paper.
Research conducted by Paul Langley, Adelaide South Australia. Research and personal information regarding the life of Charles Pecher provided by Mrs Janine Pecher – Webbles and Carla Webbles, Houston, Texas, USA, and through them, knowledge held by the Pecher family of Belgium.
The personal knowledge of Janine and the skilled research of Carla has added immeasurably to the detail and value of this chronological history. Information sourced from the Pecher family in Belgium by Carla is particularly valuable and appreciated. As well as re establishing the importance of the work of Charles and Jacqueline, the information is crucial in obtaining a fuller understanding of the factors at work in free societies during war and peace.
I deeply thank the Pecher families of the US and Belgium for helping me unravel a mystery I first glimpsed in 1971 as a soldier posted to a Radiac Unit in the Australian Army. Something about the conventional views on fallout did not add up. (At that time the French government was delivering fallout to Australia via its South Pacific thermo nuclear tests.) Ihad verylittle ideaofthe answerto the riddle untilIstumbled upona reference to Charles Pecher in 1999. From there I found the strontium articles published by Charles and Jacqueline in journals stored at the South Australian Universities Joint Research Repository. They had originally arrived at the Adelaide University at the time they were published in the early 1940s despite the World War raging at the time.
I thank most sincerely Mr. Geoff Wild of England for sending me, gratis, a copy of Marshall Brucer’s classic, “A Chronology of Nuclear Medicine”.
On finding that the United States Department of Energy “OpenNet” downloadable database of radiation experiment documents contained an error in a link, I reported it. I thank Ms Rita Hohenbrink, OpenNet Product Manager, DOE/Office of Scientific and Technical Information, Oak Ridge, TN, USA, for correcting the error and ensuring that I received the correct document, the 1950 Lawrence – Wasserman paper, “MULTIPLE MYELOMA: A STUDY OF 24 PATIENTS TREATED WITH RADIOACTIVE ISOTOPES (PHOSPHORUS AND STRONTIUM)”. The contrast between the openness of US authorities compared to Australian custodians of radiation documentation is extremely striking.
There is an unanswered question in my mind. Given the importance of calcium to the healthy functioning of the nervous system, what effects might arise when calcium is replaced by radio strontium within that system?
Paul Langley Feburary 2009
 “Human Radiation Experiments Reflections on the Ethics of Biomedical Research”, lecture, delivered Milano, Italy, 12/5/98. Faden, Ruth R., former Chair, ACHRE, who stated: “Indeed, we concluded that the secrecy with which some of these human radiation experiments and also these intentional releases were conducted was responsible for most of the serious negative consequences in this period of the American history. And these consequences were primarily the distrust and suspicion that they engendered among the American public. When we uncovered that in most cases this secrecy was not required for national security, but rather was maintained to prevent legal consequences and also to prevent bad press, it only added to a sense of skepticism and distrust, and this distrust is a great concern to all of us who believe in the importance of the advance in science.” Ms Faden is: Philip Franklin Wagley Professor of Biomedical Ethics and Director, The Bioethics lnstitute Johns Hopkins University Baltimore, Maryland; Senior Research Scholar, Kennedy lnstitute of Ethics, Georgetown University Washington, D.C. Lecture text available at: http://www.cesil.com/0798/enfade07.htm
 “Strontium 90 in the Australian Environment, 1957 to 1960” by Bryant, Dwyer, Moroney, Stevens and Titterton, of the Atomic Weapons Test Safety Committee, published “The Australian Journal of Science”, Vol. 24, No. 10, P. 397
A Medical Rediscovery but a Military Constant
 Firusian, N., Schmidt, C.G., Dusch Med Wochenschr. 1973 Dec 7;98 (49):2347-51 4763877 (P,S,E,B) Radioactive strontium for treating incurable pain in skeletal neoplasms, in German.
 Schmidt, C.G., Firusian, N.: 89-Sr for the treatment incurable pain in patients with neoplastic osseous infiltrations. J Clin Pharmacol Ther Toxicol, 1974; 9: 199-205) and 1976 (Firusian N, Mellin P, Schmidt CG, “Results of 89strontium therapy in patients with carcinoma of the prostate and incurable pain from bone metastases: a preliminary report”, J Urol. 1976 Dec;116(6):764-8.).
 Suresh C. Srivastava, S. C., “The role of electron-emitting radiopharmaceuticals in the palliative treatment of metastatic bone pain and for radiosynovectomy: applications of conversion electron emitter Tin-117m” * , Brazilian Archives of Biology and Technology ISSN 1516-8913 versã
o impressa Braz. arch. biol. technol. v.50 n.spe Curitiba set. 2007. *Brookhaven National Laboratory, Medical Department, Building 801,P.O. Box 5000, Upton, firstname.lastname@example.org; 11973-5000, NewYork – USA.
 New York Times; May 1, 1950; ProQuest Historical Newspapers, The New York Times pp. 3).
 Lawrence, J.H., Wasserman L.R. “Multiplemyeloma: A study of 24 patients treated with radioactive isotopes 32P and 89Sr. Ann Intern Med 1950; 33:41-45.”
 GE Healthcare, Metastron ™ Strontium 89 chloride description sheet.
 Science, Supplement, Vol. 94, No. 2442, 17 Oct. 1941, pp 8.
The Breach in the History of Medicine -A Brief Comparison of Papers
 Pecher, C., et. al. “Biological Investigations with Radioactive Calcium and Strontium, Preliminary Report on the Use of Radioactive Strontium in the Treatment of Metastatic Bone Cancer”, University of California Publications in Pharmacology, Volume 2 No 11, pp. 117-150.
 L.R., Lawrence, J. H., Wasserman, L.R., “Multiplemyeloma: a study of 24 patients treated with radioactive isotopes (32P and 89Sr.)” Ann Intern Med 1950; 33:41-45.
 Firusian N, Mellin P, Schmidt CG. (Germany) “Results of 89 strontium therapy in patients with carcinoma of the prostate and incurable pain from bone metastases: a preliminary report.” J Urol. 1976 Dec;116(6):764-8.
 “Use of Bone Scintigraphy to Select Patients with Multiple Myeloma for Treatment with Strontium-89”, Keith Edwards, James Santoro and Andrew Taylor ,Jr. Ernoty, University School of Medicine, Department of Radiology, Division of Nuclear Medicine, Atlanta; and Intercommunity Cancer Center at Rome, Rome, Georgia, J Nucl Med 1994; 35:1992-1993.
 V. Ralph McCready (Joint Department of Medical Physics, Institute of Cancer Research and Royal Marsden Hospital, Sutton, Surrey SM2 5PT, UK, Milestones in nuclear medicine Eur J Nucl Med (2000) 27 (Suppl): S49–S79.
 ACHRE, Executive Summary, page v. President Clinton established the Advisory Committee on Human Radiation Experiments (ACHRE) in response to public concern over unethical human radiation experiments and releases of radiation during the Cold War era. The actual period covered by the investigations covered the period 1944 to 1975. During this time several thousand human experiments had been conducted. President Clinton formally apologized to all subjects of these experiments on behalf of the government.
Finally I urge Flinders University and Bobby Scott to note well the words of
Guttentag, 1951, above.
The whole concept of leaving Hansford and other sites unremediated has no benefit, as proposed by Scott (using Sykes). In fact such deliberate exposures of entire populations without consent is a breach of the Nuremberg Protocols as explained by ACHRE. And well should he and Flinders University know it.