Archive for January, 2011

Australian Veterans’ Affairs Annual Report – Nuke Vet amendments

January 28, 2011

COVERAGE FOR BRITISH NUCLEAR TEST PARTICIPANTS
(AUSTRALIA, MILITARY PERSONNEL)
As part of the government’s response to the revisitation of the unimplemented
Recommendations of the Clarke Review, the VEA has been amended to add a new
category of service titled ‘British Nuclear Test Defence’ Service in a 2010-11 Budget
Initiative. Effective l July2 010, defence personnel who participated in the British nuclear
test program in Australia will be able to access compensation and health care treatment
under the VEA for conditions accepted as related to this service. Widows and dependent
Children of deceased defence participants will also have access to pensions and health
care treatment as a result of this measure. Prior to l July 2010, defence participants in
British nuclear testing could only access compensation under the Safety, Rehabilitation
and Compensation Act 1988 and non-liability health care treatment for malignant
cancers under the Australian participants in the British Nuclear Tests (Treatment)
Act 2006.

PAGE 106 DEPARTMENT OF VETERANS’ AFFAIRS ANNUAL REPORT 2009-2010

Forwarded by Ric Johnstone
National President
Australian Nuclear Veterans Association
(ANVA)
nucvet@bigpond.net.au

Took Ric and all the others quite a few years to achieve this small but welcome
Advance in the care, rights, and acceptance of Australian nuclear veterans.

Since 1957 and earlier in fact.

The above small gains were announced by then Prime Minister Kevin Rudd.

Downwinder Day – 2011 USA – from Andrew Kishner

January 27, 2011

Dear Friend of Idealist.ws,

Sixty years ago today, the U.S. Atomic Energy Commission conducted its
first ‘experimental nuclear detonation’ at the Las Vegas Bombing and
Gunnery Range. The date was January 27, 1951. The time was 5:45 am.
The bomb test was dubbed ‘Able.’

No one but those with military clearance knew about the test. No one
but those with military clearance knew about the radioactive clouds
that floated above the continental United States. No one was warned
about the dangers of nuclear radiation that would permeate the air and
fall on crops, homes and cisterns.

Able was the first air-dropped nuclear bomb on U.S. soil and, as with
airbursts like those that occurred over Hiroshima and Nagasaki, the
greatest ‘fallout’ occurred where there was the greatest
precipitation. Nearly 36 hours after detonation, ‘nuclear clouds’
encountered a snowstorm in Rochester, New York, and began increasing
radiation levels. Kodak’s Geiger Counters recorded readings 25 times
background radiation levels. Determined to get to the bottom of what
was causing the radiation spike, which would have very real threats to
the company’s film supplies, Kodak officials filed a complaint with a
Washington lobby group that cabled the AEC with the following message:

“Tests snowfall Rochester Monday by Eastman Kodak Company give 10,000
counts per minute, whereas equal volume snow falling previous Friday
gave only 400 STOP. Situation serious STOP. Will report any further
results obtained STOP. What are you doing? STOP”

The following day, the AEC released a statement to the Associated
Press saying that it was “investigating reports that snow that fell in
Rochester was measurably radioactive…” Nothing was said about
conducting an atom bomb test.

Sometime later, Kodak was the first to learn the truth – an AEC
Commissioner told a general manager at Kodak that a nuclear test had
taken place in Nevada two days before their elevated readings took
place. Kodak, naturally, feared that the atom bomb test program of
the AEC would, like in a 1945 incident after ‘Trinity,’ cause damage
to their film stock.

Kodak threatened to sue the AEC. The AEC capitulated to the legal
threats. Kodak was given ‘Q Clearance’ for maps and forecasts of all
bomb tests.

When it was learned years later that no American was given these maps
and forecasts – only Kodak and its industry peers – the reaction of
those who came to realize their bodies too became ‘exposed’ by the
fallout was one of anger and rage. Iowa Senator Tom Harkin, a friend
to the ‘downwinder’ cause, bitterly remarked in a 1997 Congressional
subcommittee hearing: “Where, I ask, were the maps for dairy farmers?
Where were the warnings to parents of children in these areas? …Why
do you suppose it was that the Government of the United States saw fit
to inform Kodak about fallout and to give them advance warnings on
where the hot spots would be, but would not do so for the general
public, especially in Utah and Idaho and places like that? I am
speculating here. Why would the Government not say: Look, we are going
to have an atomic bomb blast; for the next couple of months, people in
this area, you ought not to drink milk. Why was that not done? I mean,
they told Kodak to protect their films.”

Over the 60 years since the detonation of ‘Able,’ American downwinders
have pushed with fortitude and confidence to fix a broken, corrupt
system that will not recognize their worth as human beings.

By the late 1970s, when downwinders managed to organize a legal and
grassroots campaign to bolster their cause, the U.S. nuclear
locomotive had left the station. That train, loaded with lies and
money and power and hegemony all provided by the granted wishes of the
nuclear genie, couldn’t be stopped for any legal or moral reason.
The Supreme Court, a half-dozen Presidents and a myriad of bemused
Congresspersons have failed to bring justice to the radiation injuries
posed by fallout. That fallout would come from decades of U.S.
nuclear testing in Nevada, hydrogen bomb exploding cataclysms in the
Pacific Proving Grounds and later ‘Plowshare experiments,’ which sent
plumes of radioactive steam and ‘flared’ radioactive gases across
towns and hamlets in Colorado, Alaska and New Mexico.

The downwinders couldn’t keep up with the train and their movement has
since been dying. Eleanore Fanire-Lindquist, who was a co-founder of
Mohave Downwinders, tirelessly crusaded in the last years of her life
for the rights of downwinders and on November 11, 2009, succumbed to
her second bout of cancer in her life.

Eleanore, along with her colleagues in Utah and Idaho, fought for
years to have a box on the calendar for downwinders.

It would be called “Downwinder Day,” and fall on January 27.

We need a Downwinder Day just as veterans and our countrymen need
Memorial Day.

Downwinder Day is needed to honor the memories of those whose lives
were cut short by fallout.

Downwinder Day is needed to bring compassion to human beings who were
the victims of negligent actions by their own government.

Downwinder Day is needed to acknowledge that a chapter of American
history has been swept under the rug of shame and denial and that
chapter needs to be fully and honestly examined.

Downwinder Day is needed because Americans should have been deemed
above corporations, not below them. Their lives should have been
given importance above that of a cartridge of film. They should have
known, just as Kodak’s officials knew, that the “situation is
serious.”

The question posed by Kodak to the AEC ‘What are you doing?,’ is a
rhetorical question to each and every American regarding their role as
a citizen in a republic that has failed to honor its pledge to grant
each person the rights to life, liberty and pursuit of happiness.
Clearly, any analysis of the downwinders will reveal that their rights
were stripped away and given instead to a photographic film
corporation. On this Downwinder Day, I ask ‘What are you doing’ to
rectify this injustice?

-Andrew Kishner, founder, Idealist.ws
http://www.idealist.ws

A Flaw in the ACHRE Report

January 22, 2011

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
forcefully stated:
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
relationship:
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
experimentation arises.36
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
science.
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
Biomedical Experiments
Finding 1
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.
Finding 2
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
777
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
effects.
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
time.
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
experiments.
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
778
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
Finding 3
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
occluded arteries.
779
Part IV
Finding 4
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,
until 1974.
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
780
Chauter I7
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.
Finding 5
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
78 1
Part IV
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
actually implemented.
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
Finding 6
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
782
Chauter I7
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.
Finding 7
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
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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
Finding 8
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
security exceptions.
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Chatlter I7
Finding 9
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.
Finding 10
The Advisory Committee finds that even as early as 1944 it was
conventional for physicians and other biomedical scientists to obtain consent
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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
interventions.
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
Finding 11
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
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ChaDter I7
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
considered wrong.
1 IC. The Advisory Committee finds that government officials and
investigators are blameworthy for not having had policies and practices in
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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
consent.
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Chauter I7
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.
Population Exposures
Finding 12
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
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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
1953 policy.
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
Finding 13
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
790
Chavter I7
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
Alaska.
Finding 14
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.
Finding 15
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
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Part IV
Environmental Policy Act of 1969 that public review of federal actions likely to
have a significant impact on the environment was institutionalized.
Finding 16
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.
Finding 17
The Committee finds that since the end of the Manhattan Project in
1946 human radiation experiments (even where expressly conducted for
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ChaDter I7
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.
However:
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
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Part IV
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,
secret.
Finding 18
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.

Finding 19
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
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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
795

A PROBLEM REGARDING ACHRE FINDING THREE:
“Finding 3
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:
“Finding 3
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. [1]Publication of the results in English by Firusian et. al. occurred in 1974. [2]
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. [3]
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.” [4] 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. [5]
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 [6] of the Sr89 treatment within the parameters of use anticipated by Charles Pecher and Ernest Lawrence in 1941. [7] 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. [1]
“It seems unlikely that radio strontium will be a valuable therapeutic agent”: -Lawrence, J. H., Wasserman. [2]
“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. [3]
“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. [4]
“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 [5]
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.” [6] 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
potential carcinogen.

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.

Nursing Mothers
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.

Pediatric Use
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.

Acknowledgements
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
[12] “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
[13] “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
[1] 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.
[2] 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.).
[3] 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, suresh@bnl.gov; 11973-5000, NewYork – USA.
[4] New York Times; May 1, 1950; ProQuest Historical Newspapers, The New York Times pp. 3).
[5] 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.”
[6] GE Healthcare, Metastron ™ Strontium 89 chloride description sheet.
[7] Science, Supplement, Vol. 94, No. 2442, 17 Oct. 1941, pp 8.

The Breach in the History of Medicine -A Brief Comparison of Papers
[1] 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.
[2] 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.
[3] 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.
[4] “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.
[5] 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.
[6] 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.

Human Radiation Experiments – Reflections on the Ethics of Biomedical Research by R. Faden

January 16, 2011

Human Radiation
Experiments
Reflection on the Ethics of Biomedical research
By Ruth R, Faden

http://www.cesil.com/0798/enfade07.htm

It’s a great honour to be able to give this lecture in this important context, so I would like very much to thank my hosts. This lecture is perhaps somehow different from what is typically presented in this context. I’m neither a physicist nor a physician, and I’m not an expert in radiological science; what I would be speaking about is the story, and more importantly, the ethics of the enterprise of human research on which advances in the radiological science, and indeed in many sciences, have so often depended.
As it has already been mentioned, I will be giving an account of an American Presidential Commission that I chaired; this Commission is called The Advisory Committee on Human Radiation Experiments.
I will describe the background, who we were, why we were created, what we were charged to do, and how we did it. I will tell you our critical findings and our principal recommendations, and if time permits, I will talk with you about the American President’s response to our applications.
First let me tell you about the story. In the autumn of 1993, in a very obscure local newspaper in New Mexico, a reporter whose name is Eileen Welsome published a series of investigations in which she claimed that there had been secret experiments conducted by the American Government in the 1940s in which unsuspecting hospital patients had been injected with plutonium.
She identified who these victims, as she called them, were, she interviewed their families and included photographs in the report; she essentially put the human faces in this accusation. For this report she subsequently won the highest prize for journalism in the USA, the Pulitzer Prize.
When the report came out, it captured the imagination of the national press. The stories appeared in the major newspapers of all the USA, and also in the TV news.
The accusations extended not only to these plutonium experiments, but also to claims that there had been experiments involving retarded children, pregnant women, and prisoners.
The response from President Clinton to decrease public outrage was to establish an independent National Commission, and this is the Commission I had the opportunity to chair.
President Clinton appointed fourteen members, four of whom had expertise in radiological science.
My other colleagues had expertise in Biostatistics, Epidemiology, Law, Ethics and History. The President gave us four charges.
The first was to investigate what had happened and, as Clinton described us, to tell the truth to the American public. Secondly it was assumed almost from the beginning that there would be some truth in these accusations, therefore we would uncover an unpleasant story. So we were asked to identify the appropriate moral standards for judging these events.
The essential question here was whether to judge the past by the standard of the past or the standard of the present, or indeed whether ethical standards can be permitted to change over time.
Our third task was essentially a public health task; we were asked to determine if there was any justification on medical grounds for notifying former subjects of radiation experiments so as to protect their health.
And finally President Clinton was concerned, and I believe rightly, that if we uncovered disturbing news, the American public would have feared that the same events worked on today, and that especially patients of hospitals would have feared that they were being the subjects of secret experiments and especially of secret radiation experiments.
Therefore he asked us to investigate not only the past but the present, and make a statement to the public about the likelihood that unethical experiments could still be going on.
But let me tell you a little bit about how we did it. We were essentially two Commissions in one; we were a Bioethics Commission and an Ethics Commission, but we were also what is called sometimes an ‘open commission’.
There had been very grave accusations against the Government and against the American scientific establishment,
appeared in the major newspapers of all the USA, and also in the TV news.
The accusations extended not only to these plutonium experiments, but also to claims that there had been experiments involving retarded children, pregnant women, and prisoners.
The response from President Clinton to decrease public outrage was to establish an independent National Commission, and this is the Commission I had the opportunity to chair.
President Clinton appointed fourteen members, four of whom had expertise in radiological science.
My other colleagues had expertise in Biostatistics, Epidemiology, Law, Ethics and History. The President gave us four charges.
The first was to investigate what had happened and, as Clinton described us, to tell the truth to the American public. Secondly it was assumed almost from the beginning that there would be some truth in these accusations, therefore we would uncover an unpleasant story. So we were asked to identify the appropriate moral standards for judging these events.
The essential question here was whether to judge the past by the standard of the past or the standard of the present, or indeed whether ethical standards can be permitted to change over time.
Our third task was essentially a public health task; we were asked to determine if there was any justification on medical grounds for notifying former subjects of radiation experiments so as to protect their health.
And finally President Clinton was concerned, and I believe rightly, that if we uncovered disturbing news, the American public would have feared that the same events worked on today, and that especially patients of hospitals would have feared that they were being the subjects of secret experiments and especially of secret radiation experiments.
Therefore he asked us to investigate not only the past but the present, and make a statement to the public about the likelihood that unethical experiments could still be going on.
But let me tell you a little bit about how we did it. We were essentially two Commissions in one; we were a Bioethics Commission and an Ethics Commission, but we were also what is called sometimes an ‘open commission’.
There had been very grave accusations against the Government and against the American scientific establishment, accusations of violations of human rights, and the concern was that no one would have trusted the results of a statement from the Government.
So we were established as an independent Commission with authority from the President to require from Federal agencies that they made available any document that might bear on our research.
We were to open the secret reports of Federal agencies to the American public. We had responsibility over six ministries: Ministry of Defence, Ministry of Energy, Ministry of Health and Human Services, Veterans Affairs, Space Agency NASA, and also the CIA. In addition to our authority to demand from these agencies that we reviewed the reports, the agencies were also required to respond immediately to any request that we might have made for the declassification of secret documents.

It’s a great honour to be able to give this lecture in this important context, so I would like very much to thank my hosts. This lecture is perhaps somehow different from what is typically presented in this context. I’m neither a physicist nor a physician, and I’m not an expert in radiological science; what I would be speaking about is the story, and more importantly, the ethics of the enterprise of human research on which advances in the radiological science, and indeed in many sciences, have so often depended.
As it has already been mentioned, I will be giving an account of an American Presidential Commission that I chaired; this Commission is called The Advisory Committee on Human Radiation Experiments.
I will describe the background, who we were, why we were created, what we were charged to do, and how we did it. I will tell you our critical findings and our principal recommendations, and if time permits, I will talk with you about the American President’s response to our applications.
First let me tell you about the story. In the autumn of 1993, in a very obscure local newspaper in New Mexico, a reporter whose name is Eileen Welsome published a series of investigations in which she claimed that there had been secret experiments conducted by the American Government in the 1940s in which unsuspecting hospital patients had been injected with plutonium.
She identified who these victims, as she called them, were, she interviewed their families and included photographs in the report; she essentially put the human faces in this accusation. For this report she subsequently won the highest prize for journalism in the USA, the Pulitzer Prize.
When the report came out, it captured the imagination of the national press. The stories appeared in the major newspapers of all the USA, and also in the TV news.
The accusations extended not only to these plutonium experiments, but also to claims that there had been experiments involving retarded children, pregnant women, and prisoners.
The response from President Clinton to decrease public outrage was to establish an independent National Commission, and this is the Commission I had the opportunity to chair.
President Clinton appointed fourteen members, four of whom had expertise in radiological science.
My other colleagues had expertise in Biostatistics, Epidemiology, Law, Ethics and History. The President gave us four charges.
The first was to investigate what had happened and, as Clinton described us, to tell the truth to the American public. Secondly it was assumed almost from the beginning that there would be some truth in these accusations, therefore we would uncover an unpleasant story. So we were asked to identify the appropriate moral standards for judging these events.
The essential question here was whether to judge the past by the standard of the past or the standard of the present, or indeed whether ethical standards can be permitted to change over time.
Our third task was essentially a public health task; we were asked to determine if there was any justification on medical grounds for notifying former subjects of radiation experiments so as to protect their health.
And finally President Clinton was concerned, and I believe rightly, that if we uncovered disturbing news, the American public would have feared that the same events worked on today, and that especially patients of hospitals would have feared that they were being the subjects of secret experiments and especially of secret radiation experiments.
Therefore he asked us to investigate not only the past but the present, and make a statement to the public about the likelihood that unethical experiments could still be going on.
But let me tell you a little bit about how we did it. We were essentially two Commissions in one; we were a Bioethics Commission and an Ethics Commission, but we were also what is called sometimes an ‘open commission’.
There had been very grave accusations against the Government and against the American scientific establishment, accusations of violations of human rights, and the concern was that no one would have trusted the results of a statement from the Government.
So we were established as an independent Commission with authority from the President to require from Federal agencies that they made available any document that might bear on our research.
We were to open the secret reports of Federal agencies to the American public. We had responsibility over six ministries: Ministry of Defence, Ministry of Energy, Ministry of Health and Human Services, Veterans Affairs, Space Agency NASA, and also the CIA. In addition to our authority to demand from these agencies that we reviewed the reports, the agencies were also required to respond immediately to any request that we might have made for the declassification of secret documents.
All together we collected over 4000 documents, and one thing that made me particularly proud was that we were responsible for the declassification of literally thousands of documents of the Cold War.
In addition to this massive search for documents, we also conducted 20 open public meetings in which we collected testimonies from over 200 witnesses in all the USA who claimed to have knowledge about radiation experiments, including former subjects and their families.
The time we were asked to investigate went from President Roosevelt to President Ford.
We were also, as I’ve already mentioned, asked to investigate the current state of USA research involving human subjects.
To conduct this investigation, we interviewed 900 cancer and heart patients – half of whom were involved in radiation therapy – about their involvement in this research.
These were patients from five different regions of the USA, from 16 different hospitals, and we checked their understanding against the medical research reports.
We also took a random example on 125 experiments currently being funded by the American Government; about half of these experiments involved the exposure of human beings to ionizing radiation.
Here we reviewed all the documents that were available about these experiments.
All together we had 18 months. Then we published the final report that I would have brought with me but it was too heavy (900 pages long).
As you might imagine, we’ve had an enormous task; in order to make our project manageable, we adopted the strategy of identifying case studies: Several of these case studies pursued the accusations that had been made in the press; so one case study investigated plutonium experiments, one case study investigated radiation experiments in which the subjects were children, another radiation experiments in which the subjects were prisoners, and the other four involved radiation experiments in which the subjects were cancer patients exposed to total-body radiation.
Some of our studies, however, didn’t focus on classic human experiments. We were also requested by the President to investigate whether there had been accusations of secret intentional releases of radiation into the environment, or espionage experiments. We also investigated the experiences of what we call in the USA the Atomic Veterans; these were soldiers who in some respect participated in the atomic bomb testing, primarily in the 1950s. We also investigated the experience of the USA’s involvement in testing in the Marshall Islands in the Pacific, and also the experience of miners in Uranian mines in the South West of the USA in the 1950s and 1960s. Now let me tell you something about our findings.
First with respect to human radiation experiments in the past.
We concluded that generally radiation research was not different in its effects from other areas of medical research involving human subjects, with a few important exceptions.
The number of the experiments involving human subjects and exposure to ionic radiation numbered in ten thousands; most of these experiments were not connected with national security or natural concerns, and involved radioactive tracers administered in amounts that are similar to those that would be acceptable today, with one exception; the doses that were permitted with children were higher than we would allow now, and are associated with the increases in the potential lifetime risk of developing thyroid cancer.
We can’t conclude that no one was harmed by the experiments.
Finally, on the importance that ethics should have had on these experiments, it was very traumatic for us to know that even in the 1950s the Atomic Energy Commission, our Departure of Defence and our principal research institute, called The National Institute of Health, recognized that research should proceed only with the consent of the human subjects, nevertheless there was a very small evidence that consent had been obtained from patients when they were used as subjects.
We were especially disturbed about research that was not therapeutic in any respect; by this I mean research that even at that time offered no prospect of medical benefit to the subject. In such research, even at that time it would have been unethical in terms of the rules of the American Medical Community to conduct such research without express consent.
And yet, this kind of non-therapeutic research was not only conducted on patients without their acknowledge nor their consent, but in a few cases there was a deception to patients and their families about the purpose of the research.
Now I should emphasize that we had substantial historical evidence that this kind of deception occurred not only in radiation research, but more generally in medical research at that time.
We were also very concerned about the selections of subjects for this research, as far as we could discover that research in which the subjects were children was not connected with military objectives.
Much of this research in fact was directed to objectives in nutrition. What disturbed us was not the purpose but the fact that the children that were the subjects were institutionalized, mentally retarded children and children abandoned by their parents.
The rational for selecting these children was that they needed a group of children whose dignity could be controlled, so that the serial could have tracers. However, one of my colleagues said: “Why didn’t they select children institutionalized in selected private schools?” As the research was so beneficial, the children in this research were offered incentives for the multiple blood sample that they experienced.
And these incentives were very impressive; they were offered a chance for a trip to the beach which was something that they had never got a chance to do. They were told they would join in a science club, where they would get special presents.
So although doses were very low, relatively speaking, the concern about ethics come from the selection of the powerless, and the misrepresentation to the children and their parents of what was going on.
Let me quickly tell you about the intentional release of radiation in the environment. When we were commissioned, it was suspected that perhaps there had been six or seven of these releases from the State of Washington, in which there is a very important factory which produces material that supports weapon. In fact there were several hundreds of such releases, but they were not for the purpose of studying the effects of radiation on human beings.
Rather, as I mentioned earlier, their purpose was to establish whether we could detect what the Soviets were producing; if we knew how much we were releasing we could, by spying plans, correctly detect the amount and correctly infer production of the plants in the Soviet Union.
We are currently engaged in carrying out a dose reconstruction research. It’s extremely unlikely however that members of the public were harmed as a consequence of these releases; it must be remembered that these plants continued in their release to contaminate the environment.
What was deeply disturbing, however, was the fact that these releases were not only being conducted secretly, which might have been justifiable at that time, but that they were being kept secret for forty or fifty years, despite repeated attempts by the local community to establish what had happened. 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 scepticism and distrust, and this distrust is a great concern to all of us who believe in the importance of the advance in science.
Let me say a few words about what we learned on the current state of research involving human subjects.
First of all we found little difference about radiation research, compared with other research involving human subjects, and we found evidence that much research is today conducted in accordance with the highest ethical standards but, as it is always the case, we also found evidence of a significant moral concern. The term we used was ‘serious deficiencies’, and it took our commission about twenty hours of deliberation to select the right term.
Primarily, these concerns were of two types.
First we found evidence of research involving incompetent adults in medical research, in which they wouldn’t benefit medically, with no clear understanding as to whom, if anyone, should have been allowed to authorize such research.
A typical example would be the research into Alzheimer’s disease, in which the subjects were involved in imagine studies, but were not able themselves to understand what was happening, and being closed in an imagine machine was for some of these patients very terrifying, even though they run essentially no medical risks, and we didn’t have the answer.
We were concerned that we needed special rules and protections.
The other area of concern involved patients that were very seriously ill, essentially patients who were at the end of their life, for whom there was not any known medical treatment, involved in very early studies of medical intervention, which very extremely unlikely to help them.
But these patients were so desperate that we were concerned that they wouldn’t understand that the research would have benefited patients that would have followed them, but not themselves personally.
Let me very quickly summarize our recommendations.
First, and this was really unprecedented, we recommended that Clinton officially apologized to the family members of some of these experiments, the ones who had supported the worst injustices from a moral standpoint; and indeed the President did make a public and personal apology.
And we also recommended that the American Government provided a financial compensation to a few of these families.
We also recommended that our laws be emended so as to restrict even further the authority of our Government to conduct secret human experiments.
This is still permitted under the American Law; however the President has responded by adopting most of our recommendations about the secrecy.
We also made several recommendations with respect to the policy of human subjects research, with a particular focus on research conducted in the military and private industries field.
Research conducted in the universities is also in need of reform; however at least in universities and in National Research Institutes we have federal laws that are somehow to protect human subjects.
These laws aren’t applied to private industries in most cases.
However, and I conclude with this, we were after all a historical commission; a commission looking at history is especially obliged to learn from history.
As I’ve mentioned to you, there were already regulations and directives in the 1940s and 1950s and 1960s at the Defence Department and the Atomic Energy Commission requiring consent, but these requirements were never followed.
We have learned from this story that the Government can write the most elaborate regulations, but there are human limits that must be set by ethics; and a good ethics in a professional context most come from within the profession, and so our major recommendation had to do with changing education and the incentives for scientists and medical investigators, so as to make ethics central to their profession.
We had some success from these recommendations, but we still have a long way to go.
Thank you very much.

Ruth R. Faden
Philip Franklin Wagley Professor
of Biomedical Ethics and Director
The Bioethics Institute
Johns Hopkins University
Baltimore, Maryland
Senior Research Scholar
Kennedy Institute of Ethics
Georgetown University
Washington, D.C.

ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS – A STUDY OF NUCLEAR FERALS

January 16, 2011

(NOTE: this 937 page report is too large to post here. Search DOE Opennet for a downloadable pdf of the report. Only the Preface is presented below.) See also George Washington University National Security Archives for links at
http://www.gwu.edu/~nsarchiv/radiation/

ADVISORY COMMITTEE
ON HUMAN RADIATION EXPERIMENTS
Final Report
October 1995

To the Members of the Human Radiation Interagency Working Group:
Secwtaiy Hazel O’Leay, Department of Energv
Secretary William Perry, Departnrent of Defense
Attorney General Janet Reno, Department of Jirstice
Secretary Donria Shalala, Department of’Health and Human Services
Secretay Jesse Brown, Departnzent of’ Veterans Aflbirs
Director Alice Rivlin, Office of Management and Budget
Director John Deutch, Central Intelligence Agemy
Adrn inistra tor Daniel Goldin ~ National Aeronautics and Space Adrii in is t rat ion
On behalf of the Advisory Committee on Human Radiation Experiments, it is my
privilege to transmit to you our Final Report.
Since the Committee’s first meeting in April 1994 we have been able to conduct
an intensive inquiry into the history of government-sponsored human radiation
experiments and intentional environmental releases of radiation that occurred between
1944 and 1974. We have studied the ethical standards of that time and of today and have
developed a moral framework for evaluating these experiments. Finally, we have
examined the extent to which current policies and practices appear to protect the rights
and interests of today’s human subjects. This report documents our findings and makes
recommendations for your consideration.
The committee listened to the testimony of more than 200 public witnesses who
appeared before us. We are deeply grateful to all these witnesses, who overcame the
obstacles of geography and emotions to assist us.
Our work and this report would not have been possible without the extraordinary
effort the President and you put forward to open the government’s records to our inquiry
and thus to the nation. We are especially pleased that, through our joint efforts, the
American people now have access to the tens of thousands of documents that bear on this
important history.
None of our conclusions came easily. We endeavored, both as individuals and as
a committee, to live up to the responsibility with which we were entrusted. This report
represents the consensus of fair-minded people who gave the best they had to offer to
their fellow citizens.
We thank President Clinton for this opportunity and for his courage and
leadership in appointing the Advisory Committee.
Ruth R. Faden
Chair, Advisory Committee
on Human Radiation Experiments
PREFACE
O n January 15, 1994, President Clinton created the Advisory Committee
on Human Radiation Experiments in response to his concern about the growing
number of reports describing possibly unethical conduct of the U.S. government,
and institutions funded by the government, in the use of, or exposure to, ionizing
radiation in human beings at the height of the Cold War. He directed us to
uncover the history of human radiation experiments and intentional environmental
releases of radiation; to identify the ethical and scientific standards for evaluating
these events; and to make recommendations to ensure that whatever wrongdoing
may have occurred in the past cannot be repeated.
representative and thirteen experts in bioethics, radiation oncology and biology,
epidemiology and statistics, public health, history of science and medicine,
nuclear medicine, and law. We report to a Cabinet-level group convened by the
President (the Human Radiation Interagency Working Group), whose members
are the secretaries of defense, energy, health and human services, and veterans
affairs; the attorney general; the administrator of the National Aeronautics and
Space Administration; the director of the Central Intelligence Agency; and the
director of the Office of Management and Budget.
President Clinton invited us to the White House to personally communicate his
commitment to the process we were about to undertake. He urged us to be fair,
thorough, and unafraid to shine the light of truth on this hidden and poorly
understood aspect of our nation’s past. Our most important task, he said, was to
tell the full story to the American public. At the same time, we were also to
examine the present, to determine how the conduct of human radiation research
today compares with that of the past and to assess whether, in the light of this
inquiry, changes need to be made in the policies of the federal government to
better protect the American people. This report and the accompanying
The Advisory Committee is composed of fourteen members: a citizen
On April 2 1, 1994, at the end of the first day of our opening meeting,
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Preface
supplemental volumes constitute the Committee’s attempt to tell the story of the
past and to report on our inquiry into the present.
WHY THE COMMITTEE WAS CREATED
Past research with human subjects, including human radiation research,
has been a source of life-saving knowledge. 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.
surrounding human radiation experiments that were conducted half a century
ago. In November 1993, the Albuquerque Tribune published a series of articles
that, for the first time, publicly revealed the names of Americans who had been
injected with plutonium, the man-made material that was a key ingredient of the
atom bomb. Reporter Eileen Welsome put a human face to what had previously
been anonymous data published in official reports and technical journals. As
World War I1 was ending, she wrote, doctors in the United States injected a
number of hospitalized patients with plutonium, very likely without their
knowledge or consent. The injections were part of a group of experiments to
determine how plutonium courses through the human body. The experiments,
and the very existence of plutonium, were shrouded in secrecy. They were
conducted at the direction of the U.S. government, with the assistance of
university researchers in Berkeley, Chicago, and Rochester (New York), with the
expectation that the information gained could be used to limit the hazards to the
thousands of workers laboring to build the bomb.
shock, first to her staff, and then in response to a question posed at a press
conference. She was particularly concerned because the Department of Energy
had its earliest origins in the agencies responsible for building the atomic bomb
and sponsoring the plutonium experiments. During the Cold War, these agencies
had continued to do much of their work in the twilight zone between openness
and secrecy. Now, the Cold War was over. The time had come, Secretary
The Committee had its origins when public controversy developed
On reading the articles, Secretary of Energy Hazel O’Leary expressed
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Preface
O’Leary determined, to make public anything that remained to be told about the
plutonium experiments.
not the only human radiation experiments that had been conducted during the war
and the decades that followed. In Massachusetts, the press reported that members
of the “science club” at the Fernald School for the Retarded had been fed oatmeal
containing minute amounts of radioactive material. In Ohio, news articles revived
an old controversy about University of Cincinnati researchers who had been
hnded by the Defense Department to gather data on the effects of “total-body
irradiation” on cancer patients. In the Northwest, the papers retold the story of
Atomic Energy Commission funding of researchers to irradiate the testicles of
inmates in Oregon and Washington prisons in order to gain knowledge for use in
government programs. The virtually forgotten 1986 report prepared by a
subcommittee headed by U.S. Representative Edward Markey, “American
Nuclear Guinea Pigs: Three Decades of Radiation Experiments on U.S.
Citizens,” was also recalled to public attention.’
secret laboratory became a subject of controversy. A November 1993
congressional report uncovered thirteen cases in which government agencies had
intentionally released radiation into the environment without notifying the
affected populations.2 At various times, tests were conducted in Tennessee, Utah,
New Mexico, and Washington state. This report had been prepared at the request
of Senator John Glenn in his capacity as chair of a committee that had undertaken
a comprehensive oversight investigation of the nuclear weapons complex. As a
young marine in 1945, the senator was in a squadron being trained for possible
deployment to Japan when the atomic bomb ended the war; as an astronaut, he
had been the subject of constant testing and medical monitoring by space
administration flight surgeons; as a senator he was at the center of the country’s
efforts to understand and control nuclear weapons. Senator Glenn understood the
importance of national security, but he found it “inconceivable . . . that, even at
the height of the communist threat, some of our scientists and doctors and military
and perhaps political leaders approved some of these experiments to be conducted
on an unknowing and unwitting public.”3
the further press reports, thousands of callers flooded the Department of Energy’s
phone lines to recount their own experiences and those of friends and family
members.
and members of the public were many unanswered questions. How many human
radiation experiments were conducted? No one knew if the number was closer to
100 or 1,000. Were all the human radiation experiments done in secret, and were
any of them still secret? Are any secret or controversial studies still ongoing?
Subsequent press reports soon noted that the plutonium injections were
Coincidentally, the fact that the environment had also been used as a
In the immediate aftermath of Secretary O’Leary’s press conference and
Underlying the outrage and concern expressed by government officials
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Preface
Scientists and science journalists pointed out that some of the highly publicized
experiments had long ago been the subject of technical journal articles, even press
accounts, and were old news; other commentators countered that, for most of the
public, articles in technical journals might as well be secret.
experiments? Some suspected that subjects were disproportionately chosen from
the most vulnerable populations–children, hospitalized patients, the retarded, the
poor–those too powerless to resist the government and its researchers.
Did the experiments benefit the American people through the
advancement of science and the enhancement of the ability to treat disease?
How many intentional releases took place, and how many people were
unknowingly put at risk? The answer here was sketchy; the releases identified in
the November 1993 Glenn report had all been performed in secret, and much
information about them was still secret.
How great were the risks to which people were exposed? Many pointed
out that radiation is not only present in our natural environment, but that, as a
result of biomedical research, most people routinely rely on radiation as a means
of diagnosing and treating disease. Others noted that while this is so, radiation
can be abused, and the potential dangers of low-level exposure are still not well
understood.
What did our government and the medical researchers it sponsored do to
ensure that the subjects were informed of what would be done to them and that
they were given meaningful opportunities to consent? Today, federal government
rules require the prior review of proposed experiments, to ensure that the risks
and potential benefits have been considered and that subjects will be adequately
informed and given the opportunity to consent. But the standards of today, many
historians and scholars of medical ethics noted, are not those of yesterday.
Others, however, declared that it was self-evident that no one should be
experimented upon without his or her voluntary consent. Indeed, it was pointed
out that this very principle was proclaimed aloud to the world in 1947, as the
plutonium experiments were coming to a close. It was the American judges at the
international war crimes trials in Nuremberg, Germany, who invoked the
principle in finding doctors guilty of war crimes for their vile experiments on
inmates of Nazi concentration camps. How could yesterday’s standard have been
less strict than that of today? How, moreover, could the standard not have been
known by the government that sponsored the experiments and the researchers
who conducted them?
Finally, there were questions about how human experiments are
conducted today. Insofar as wrong things happened in the past, how confident
should we be that they could not happen again? Have practices changed? Do we
have the right rules, and are they implemented and enforced?
How, why, and from what population groups were subjects selected for
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Preface
THE PRESIDENT’S CHARGE

The Advisory Committee was created under the Federal Advisory
Committee Act of 1972, which provides that committee meetings and basic
decision making be conducted in the open. The Committee’s charter4 defined
human radiation experiments to include
( 1) experiments on individuals involving intentional exposure to
ionizing radiation. This category does not include common and
routine clinical practices. . . .
(2) experiments involving intentional environmental releases of
radiation that (A) were designed to test human health effects of
ionizing radiation; or (B) were designed to test the extent of human
exposure to ionizing radiation.
The Committee was mandated to review experiments conducted between
1944 and 1974, the latter being the year that the U.S. Department of Health,
Education, and Welfare issued rules for the protection of human subjects of
federally sponsored research. The Committee was asked to determine the ethical
and scientific standards by which to evaluate the pre- 1974 experiments and the
extent to which these experiments were consistent with such standards. We were
also to ”consider whether (A) there was a clear medical or scientific purpose for
the experiments; (B) appropriate medical follow-up was conducted; and (C) the
experiments’ design and administration adequately met the ethical and scientific
criteria, including standards of informed consent, that prevailed at the time of the
experiments and that exists today.” The charter also directed that, upon
completing our review, the Committee may recommend that subjects (or families)
be notified of potential health risks and the need for medical follow-up and also
that we “may recommend further policies, as needed, to ensure compliance with
recommended ethical and scientific standards for human radiation experiments.”
human subjects taking place today, we were authorized to sample and consider
examples of research with human subjects currently under way.
In essence, we were to answer several fundamental questions: (1) What
was the federal government’s role in human radiation experiments conducted from
1944 to 1974? (2) By what standards should the ethics of these experiments be
evaluated? and (3) What lessons learned from studying past and present research
standards and practices sbuld be applied to the future?
In addition, while the Committee was not expressly charged with
considering issues relating to remedies, including financial compensation, we
have felt obliged to address the type of remedies that we believe the government,
In order to inform the public about the conduct of research involving
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Preface
as an ethical matter, should provide to subjects of experiments where the
circumstances warranted such a response.
THE COMMITTEE’S APPROACH
When those of us selected by President Clinton to serve on the Committee
read about human radiation experiments in our hometown newspapers during the
1993 holiday season, none of us imagined that within months we would be
embarking on such an intense and challenging investigation of an important
aspect of our nation’s past and present, requiring new insights and difficult
judgments about enduring ethical questions.
On April 2 1 and 22, 1994, the Committee held its first meeting, and most
of us met each other for the first time. As we listened to opening statements by
Cabinet members and members of Congress, as well as the first witness from the
general public, it became clear how daunting a task we were undertaking. We
realized that our ability to reconstruct the story of past radiation experiments
required both the capacity to join with the agencies in the search through
thousands of boxes for documents and the intuition to recognize which documents
were important. We knew that the ability to tell that story depended on our ability
to understand the full range of technically complex, often emotionally charged
issues related to human radiation experiments. We could not understand, much
less tell, the story until we sought out all who could enhance our understanding, a
difficult job because the voices to which we had to listen spoke in the varied
languages of medicine, a multiplicity of scientific disciplines, the military,
policymakers, philosophers, patients, healthy subjects, family members of former
subjects, and individuals in a variety of other roles.
Finally, we were also convinced that an important determinant of our
success in keeping faith with the American people would be to understand not
only how human subject research was conducted in the past but also how it is
being conducted in the present.
Reaching In and Reaching Out
As we began our work, Committee members first sought to educate one
another. Early meetings included basic presentations on such topics as research
ethics, radiation, the history of human experimentation, the law of remedies, and
the debate over the effects of low levels of radiation.
Then we determined to search broadly for those who could contribute to
our understanding. We hired a staff with the expertise and experience need for
the Committee’s myriad tasks. Finally, we sought to make ourselves available to
those who wanted to speak to us directly, especially people who felt they or their
loved ones were harmed, or might have been harmed, by human radiation-related
6
research or exposure. Each of the Committee’s meetings reserved a period for
public comment. Since April 1994, the full Committee held sixteen public
meetings, each of two to three days’ durdtion. Fifteen of those meetings were held
in Washington, D.C., and one was in San Francisco. In addition, subsets of
Committee members presided over public forums in Cincinnati, Knoxville, Santa
Fe, and Spokane. We traveled to these different cities in order to hear from
people who could not come to Washington, D.C., and lived in communities
where, or near where, experiments or intentional releases of interest to the
Committee had taken place. We further sought to reach out to those who could
not attend our meetings. By phone, mail, and personal visit, we and our staff
communicated with members of the public, researchers, attorneys, investigative
reporters, authors, and representatives of dozens of groups of interested people
who shared some aspect of the Committee’s concern.
The Records of Our Past: The Search for Documents
One of the most difficult tasks before the Committee was determining how
many federally sponsored human radiation experiments occurred between 1944
and 1974 and who conducted them. When President Clinton established the
Committee, he also directed the Human Radiation Interagency Working Group to
provide us with all relevant documentary information in each of the agencies’
files. Teams were formed to identify the hundreds of government sites where
relevant documents might be located. We discovered there was no easy way to
identify how many experiments had been conducted, where they took place, and
which government agencies had sponsored them. The location and retrieval of
documents thus required an extraordinary effort, and we appreciate the assistance
of all our collaborators.
We began with documents that were assembled during the 1980s and that
provided the basis for the :Markey report. But review of those materials
confirmed that, even for this relatively well-known group of experiments, basic
information was lacking. We found that the Department of Health and Human
Services (DHHS), which is the primary government sponsor of research involving
human subjects, reported that, as permitted by federal records laws, it had long
since discarded files on experiments performed decades ago. Furthermore, the
capsule descriptions of research that remained sometimes did not make clear
whether the subjects of research had been humans or animals. To complicate
matters further, the DHHS also pointed out that much research documentation had
originated and been retaiped only in the files of nonfederal grantee institutions
and investigators. Other agencies did provide some lists of experiments; in many
cases, however, there was no information on basic questions of concern (for
example, who the subjects were and what, if anything, they were told).
What rules or policies, if any, existed to govern federally sponsored
7
Preface
experiments in the pre- 1974 period? The prevailing assumption was that, with a
few notable exceptions, it was not until the mid-1960s that federal agencies began
to develop such policies in any significant way. Most scholarship focused on
divisions of the (then) Department of Health, Education, and Welfare. Little was
known about approaches to human experimentation at the Atomic Energy
Commission and the Department of Defense. Yet it was clear from the outset of
our inquiry that these agencies, as well as the DHEW, were central to the story of
human radiation experiments and that many of the experiments of interest
predated by decades the mid- 1960s’ interest in human subject protections.
As we began our search into the past, we found that it was necessary to
reconstruct a vanished world. The Committee and the agencies had to collect
information scattered in warehouses throughout the country. At the same time,
we had to create and test the framework needed to ensure that there would be a
“big picture” into which all the pieces of the puzzle would fit.
began to reemerge. Working with the Defense Department, we discovered that
long-forgotten government entities had played central roles in the planning of
midcentury atomic warfare-related medical research and experimentation. These
groups, the piecing together of long-lost or forgotten records would show,
debated the ethics of human experimentation and discussed possible human
radiation experimentation: Similarly, working with the Department of Energy, we
pieced together the minutes, and even many transcripts, of the key medical
advisory committee to the Atomic Energy Commission. We sought to mine
agency histories, when they existed: for example, at the Committee’s request, the
Defense Nuclear Agency (the heir to the part of the Manhattan Project that was
transferred to the Defense Department) made public portions of the more than 500
internal histories that chronicle its story, most of which had previously been
available only to those with security clearances.
nation’s recent history had been irretrievably lost or simply could not be located.
The Department of Energy told the Committee that all the records of the
Intelligence Division of its predecessor, the Atomic Energy Commission, had
been destroyed–mainly during the 1970s, but in some cases as late as 1989. The
CIA explained, as had been previously reported, that records of the program
known as MKULTRA, in which unwitting subjects were experimented upon with
a variety of substances, had been destroyed during the 1970s, when the program
became a widely publicized scandal. Though documents related to the program
referred to radiation, the CIA concluded that human experiments using ionizing
radiation never took place under that program, based on currently available
evidence.
Cryptic notes and fragments of correspondence located in private and university
After a few months, the outlines of a world that had been almost lost
Despite these successes, it became evident that the records of much of our
We also turned to nongovernmental archives throughout the country.
8
Preface
archives were fitted into our growing outline. For example, a copy of an
important 1954 Army surgeon general research policy statement, referenced in
Defense Department documents, was found at Yale University among the papers
of a Nobel laureate.
reviewed hundreds of thousands of pages of documents from public and private
archives. This collection will be available to individuals and scholars who wish
to pursue the great many stories that remain to be told, and we view this as one of
our most significant contribution^.^
By the end of our term, the Committee had received, organized, and
The Records of Our Past: The Memories of the People
The Committee listened to the testimony of more than 200 public
witnesses who appeared before us. We heard from people or their family
members who had been sybjects in controversial radiation experiments, including
the plutonium injections, total-body irradiation experiments, and experiments
involving the use of radioactive tracers with institutionalized children. We heard
from “atomic veterans”: soldiers who had been marched to ground zero at atomic
bomb tests, sailors who had walked the decks of ships contaminated by
radioactive mist, and pilots who had flown through radioactive mushroom clouds.
We also heard from their widows. We heard from people who lived “downwind”
from nuclear weapons tests in Nevada and intentional releases of radioactive
material in Washington state. We heard from Navajo miners who had served the
country in uranium mines filled with radioactive dust, from native Alaskans who
had been experimented upon by a military cold weather research lab, and from
Marshall Islanders, whose Pacific homeland had been contaminated by fallout
after a 1954 hydrogen bomb test.
today and from those who were present at or near the dawn of the Cold War. We
heard from individuals who, on their own time, had long been seeking to piece
together the story of human radiation experiments and offered to share their
findings. We heard from scholars, from members of Congress, and from people
who wanted to bear witness for those who could no longer speak. We heard from
a woman who, as a high-school student intern decades ago, attended at the
bedside while a terminally ill patient was injected with uranium and from a
powerfully spoken veteran of the nuclear weapons work force who told of the
“body snatching” of dead friends in the name of science.
involving the government and radiation happened to them or their loved ones
decades ago; most had been unable to find out exactly what had happened, or
why, and now they wanted to know the truth. These witnesses spoke eloquently
of their pain, their frustration, and the reasons they do not trust the government.
We heard from officials and researchers responsible for human research
Most important, we heard from many people who believed that something
9
Their very appearance before the Committee testified to a commitment to the
country and to the value of the nation’s effort to understand its past. We are
deeply grateful to all of these witnesses, who overcame the obstacles of
geography and emotions to participate in this work.
record for the nation’s archives, those who could shed light on Cold War human
radiation experiments and on the ethics of biomedical experimentation. Dozens
of interviews were conducted with former government officials responsible for
programs that included radiation research, as well as with radiation researchers.
In Mississippi we talked with a retired general who served as a military
assistant to secretaries of defense in the 1940s and 1950s; in Berkeley, we talked
with the chemist who was one of the discoverers of plutonium; in Rhode Island
we talked with the physicist who served as the link between the civilian health
and safety agencies and the Cold War military research efforts; in Florida we
talked with a pioneer in health physics, a discipline created to provide for the
safety of nuclear weapons workers; in San Francisco and Washington, D.C., we
talked to the lawyers who advised the Atomic Energy Commission at its postwar
creation; in New York we talked with the Navy radiation researcher who was
rousted from his Maryland laboratory to respond to the emergency created by the
exposure of the Marshall Islanders; in San Diego we talked with a researcher
whose own career and massive history of radiation research had covered much of
the Committee’s territory.
We also launched a special effort, called the Ethics Oral History Project,
to learn from eminent physicians who were beginning their careers in academic
medicine in the 1940s and 1950s about how research with human subjects was
then conducted. The Ethics Oral History Project also included interviews with
two people who had been administrators of the National Institutes of Health
during the 1950s, since they were intimately involved with ethical and legal
aspects of research involving human subjects at the time.
report is informed.
We combined our public meetings with additional efforts to interview, and
We listened to all these people and more, and through their testimony, this
Bounds of Our Inquiry
In the course of listening to public testimony, it became clear to us that
confusion exists about what an experiment is and whether it can be distinguished
from other activities in which people are put at risk and information is gathered
about them. The biomedical community, for example, struggles with the
distinction between scientific research and related activities. In a medical setting,
it is sometimes hard to distinguish a formal experiment designed to test the
effectiveness of a treatment from ordinary medical care in which the same
treatment is being administered outside of a research project. The patient
10
Preface
receiving the treatment may discern no difference between the two, but the
distinction is relevant to questions of ethics. The physician-investigator may face
conflicts between the obligation to do what is best for each individual patient and
the requirements of scientific research, whereas the physician involved only in
clinical care has a responsibility solely to the patient.
is often difficult to distinguish formal scientific efforts to study effects on the
health of employees from’routine monitoring of employees’ exposure to hazards
in the work place for purposes of ensuring worker safety. In the first case, the
rules of research ethics apply; in the second they do not. And yet, here too, the
worker may discern no difference between the two activities. A further
complication for the Committee to consider was the fact that research in
occupational settings rarely takes the form of a classic experiment, in which the
investigator controls the variable under study and then randomly assigns subjects
to be in the “treatment” or “control” group. Instead, most occupational research
employs observational and statistical methods, drawing most heavily from the
field of epidemiology. These distinctions were unimportant, however, to the
representatives of atomic veterans, uranium miners, and residents of the Marshall
Islands, who told us of their belief that they, or those they spoke for, were
subjects of research.
experiments for purposes of our inquiry. There is no single, clear definition of an
experiment that is widely subscribed to by every member of the biomedical
community. Even our description above of a classic experiment is open to
contest. Today, as well as in the past, the scientific community has rarely
employed the term experiment in discussions of biomedical research; other terms,
not necessarily synonymous–such as clinical study, clinical investigation, quasi
experiment, and case control study–are all used. We concluded that it was not
possible to interpret our charge by stipulating an artificial definition of human
radiation experiment. Instead, in keeping with the realities of biomedical
research, we decided to interpret our charge broadly, as including both research
involving human subjects in which the research design called for exposing
subjects to ionizing radiation and research designed to study the effects of
radiation exposure resulting from nonexperimental activities.
Marshall Islanders. In these cases we quickly determined that it was in some
respects impossible to isolate the ethical questions raised by the research from the
ethics of the context in which the research was conducted. A central issue was
the exposure of people to risk, regardless of whether they were clearly understood
to be subjects of research. This characterization is true, as well, of the experience
of atomic veterans. As a consequence, we considered events that might be said to
be on the boundary between research and some other activity. Our inquiry
Similarly, in an occupational setting in which employees are put at risk, it
The Committee struggled with how strictly to define human radiation
This latter category includes the research involving uranium miners and
11
Preface
underscored the importance for social policy of the need to keep focused on
questions of risk and well-being regardless of what side of that boundary the
activity producing the risk falls.
Human Experimentation Today
In tandem with the reconstruction of the past, we undertook three projects
to examine the current state of human radiation experiments.
First, we studied how each agency of the federal government that
currently conducts or funds research involving human subjects regulates this
activity and oversees it. We surveyed what the operative rules are, how they are
implemented, and how they are enforced.
human subjects currently supported by the federal government, we randomly
selected 125 research projects for scrutiny by the Committee. For each of these
projects, we reviewed all available relevant documentation to assess how well it
appeared the rights and interests of the subjects participating in these projects
were being protected. The success of this review required the cooperation of
private research institutions all over the country, on whom we were dependent for
access to important documents. We had expected that perhaps no more than half
of those asked to cooperate would agree to do so, but with little hesitation, all of
the research centers that we approached agreed to cooperate.
Third, to learn from the subjects themselves, the Committee interviewed
almost 1,900 patients receiving medical care in outpatient facilities of private and
federal hospitals throughout the country. We asked patients about their attitudes
toward medical research with human subjects and about the meaning they attach
to the different terms used to explain medical research to potential subjects. We
ascertained, and attempted to verify, how many of these patients were currently or
ever had been subjects of research. Patient-subjects were asked about their
reasons for agreeing to join research projects; patients who reported having
refused offers to enter research projects were asked why they had decided against
participating.
experiments but on human research generally. In critical (but not all) respects,
the government regulations that apply to human radiation research do not differ
from those that govern other kinds of research involving human subjects.
Moreover, the underlying ethical principles that should guide the conduct of
research are identical, whether one is considering human radiation research or all
research with human subjects. Finally, the Committee hoped to learn whether, in
practice, there are any differences between the conduct of radiation and
nonradiation experiments.
Second, from among the very large number of research projects involving
In all three of these projects, we focused not only on human radiation
12
Preface
LESSONS FROM HISTORY: LOOKING TO THE FUTURE
What we have found is a story about the government’s attempt to serve
two critical purposes: safeguarding national security and advancing medical
knowledge. 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
forcefully stated:
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?
In this report we try to convey our understanding of how, when only good
13
Preface
was sought, when its pursuit was entrusted to the experts on whom we most
relied, and when missions were substantially accomplished, distrust, as well as
accomplishment, remains.
the interest of individual dignity and sought to strike a balance with the national
interests being pursued. We focus equally on the extent to which the public was
privy to this balancing. In particular, we try to show how individuals’
understanding and participation were limited by the conjunction of government
secrecy and expert knowledge.
have been made toward accomplishing both our national security and our medical
research goals. However, as attested to by the many thousands of letters and calls
that led to the Committee’s creation, and the eloquent statements of the witnesses
who appeared before us, this pride is diluted by a bitter aftertaste–distrust by
many Americans of the federal government and those who served it.
The government has the power to create and keep secrets of immense
importance to us all. Secret keeping is a part of life. Secret keeping by the
government may be in the national interest. However, if government is to be
trusted, it is important to know, at the very least, the basic rules of secrecy and to
know that they are reasonable and that they are being followed.
Similarly, experts, by training and experience, have knowledge that
individual people must, as a practical matter, rely on. However, legitimate
questions arise when experts wear multiple hats or when they are relied on in
areas beyond their expertise.
focused on a public that is not privy to secrets and does not speak the languages
of experts, the potential for distrust is substantial.
for ways in which lost trust can be restored. It might be presumed that the past
we report on here is so different from the present that it will be of little use in
understanding research involving human subjects today. In fact, as we shall see,
basic questions posed by the story of human radiation experiments conducted
during the 1944-1974 period are no less relevant today. Then, as now, there were
standards; the question is how they worked to protect individuals and the public.
Then, as now, the ethical impulse was complexly alloyed with concerns for legal
liability and public image. Then, as now, the most difficult questions often
concerned the scope and practical meaning of ethical rules, rather than their
necessity. The country has come to recognize, from its experience of the past half
century, that tinkering with the regulations that govern publicly supported
institutions, imposing ethical codes on experts, and altering the balance between
secrecy and openness are important but not always sufficient means of reform.
The most important element is a citizenry that understands the limits of these
We focus on the ways in which the government and its experts recognized
All Americans should experience immense satisfaction in the strides that
Where official secrecy is coupled with expert authority, and both are
In telling the story, and asking the questions, we have kept our eyes open
14
activities. That is why the purpose of this story is not simply to learn which
changes to make in rules or policies that apply to government or professionals,
but to begin to learn something more about how the Cold War world worked, as
the most important means to making the world of tomorrow work better.
HOW THIS REPORT IS ORGANIZED
Though this report is addressed largely to those who can affect future
policy in light of the information the Advisory Committee has gathered,
specifically the Human Radiation Interagency Working Group, it has been written
in such a way that it should be accessible to a wide range of interested readers.
We begin with an introduction, titled “The Atomic Century,” which
describes the intersection of several developments: the birth and remarkable
growth of radiation science; the parallel changes in medicine and medical
research; and the intersection of these changes with government programs that
called on medical researchers to play important new roles beyond that involved in
the traditional doctor-patient relationship. The introduction concludes with a
section titled “The Basics of Radiation Science” for the lay reader.
The remainder of the text is divided into four parts. Each part is preceded
by an overview.
Part I, “Ethics of Human Subjects Research: A Historical Perspective,”
which contains four chapters, explores how both federal government agencies and
the medical profession approached human experimentation in the period 1944
through 1974. We begin with the story of the principles stated at midcentury at
the highest levels of the Cold War medical research bureaucracies and what we
have ascertained about whether these principles were translated into federal rules
or requirements. We then turn to the norms and practices engaged in at the time
by medical researchers themselves. It is in this chapter that we report the results
of our Ethics Oral History Project. In chapter 3, we review the development of
formal and public regulations concerning research involving human subjects in
the 1960s and 1970s. In the last chapter in part I we present our framework for
evaluating the ethics of human radiation experiments, grounded in both history
and philosophical analysis.
Part 11, “Case Studies,” approaches particular experiments from several
angles, each of which raises overlapping ethical questions. The chapters on the
plutonium injections and total-body irradiation consider the use of sick patients to
provide data needed to protect the health of workers engaged in the production of
nuclear weapons; the chapter on prisoners considers the use of healthy subjects
for this purpose; the chapter on children considers experimentation with
particularly vulnerable people; and the chapter on the AEC program of
radioisotope distribution considers the institutional safeguards that underlay the
conduct of thousands of human radiation experiments. The chapters on
15
Preface
intentional releases, atomic veterans, and observational studies consider, in
common, situations in which entire groups of people were exposed to risk as a
consequence of government-sponsored Cold War programs. The section
concludes with a review of the degree to which secrecy impaired, and may still
impair, our ability to understand human radiation experiments and intentional
releases conducted in the 1944- 1974 period.
inquiries into the present. We begin by describing what we have learned about
how the different federal agencies that sponsor human research regulate and
oversee this activity. Next, we report the results of our Research Proposal
Review Project, followed by the results of our Subject Interview Study. Part 111
concludes with the Committee’s synthesis of the implications of the results of all
three of these projects for the current state of human subject research.
Part IV, “Coming to Terms with the Past, Looking Ahead to the Future,”
reports the Committee’s findings and recommendations.
Part 111, “Contemporary Projects,” reports the findings of our three
A FINAL NOTE
The Committee’s findings and recommendations represent our best efforts
to distill almost eighteen months of inquiry into, debate about, and analysis of
human radiation experiments. But what they cannot fully express is the
appreciation we developed for how much damage was done to individuals and to
the American people during the period we investigated and how this damage
endures today. The damage we speak of here is not physical injury, although this
too did occur in some cases. Rather, the damage is measured in the pain felt by
people who believe that they or their loved ones were treated with disrespect for
their dignity and disregard for their interests by a government and a profession in
which they had placed their trust. It is measured in a too-often cynical citizenry,
some of whom have lost faith in their government to be honest brokers of
information about risks to the public and the purposes of government actions.
And it is measured in the confusion among patients that remains today about the
differences between medical research and medical care–differences that can
impede the ability of patients to determine what is in their own best interest.
were achieved and a foundation was laid for fifty years without a world war. At
the same time, however, it was a time of arrogance and paternalism on the part of
government officials and the biomedical community that we would not under any
circumstances wish to see repeated.
we came to feel great sorrow about the suffering they described. Our most
difficult task was determining what to recommend as the appropriate national
response to these emotions and the events that stimulated them. What can best
In the period that we examined, extraordinary advances in biomedicine
As we listened to the heart-rending testimony of many public witnesses,
16
Preface
precipitate the healing of wounds and the restoration of trust? Appropriate
remedies for those who were wronged or harmed were of critical importance, but
remedies alone speak only to the past, not the future. It is equally important that,
the historical record having been spelled out and appropriate remedies identified,
we as a nation move forward and take action to prevent similar occurrences from
happening in the future. In the end, if trust in government is to be restored, those
in power must always act in good faith in their dealings with the citizenry. At the
same time, however, we must recognize that unless we have expectations of
honesty and fairness from our government and unless we are vigilant in holding
the government to those expectations, trust will never be restored.
Finally, we hope that this report conveys the sense of gratitude and honor
that we experienced as citizens serving on the Advisory Committee. We were
provided by the President with extraordinary access to the records of our past and
given complete liberty to deliberate on what we found. Although some of what
we report is a matter for national regret, our freedom of inquiry, and the
cooperation we received from officials and fellow citizens of all perspectives,
confirms that our nation’s highest traditions are not things of the past but live very
much in the present.
17
End Preface.

see also
http://naffoundation.org/US%20TRC.htm

Which contains:
Testimonies presented by survivors and concerned professionals before the US Advisory Committee on Human Radiation Experiments (US ACHRE) in Washington, DC on March 15, 1995

Official transcript of all testimonies presented by survivors and concerned professionals before the US Advisory Committee on Human Radiation Experiments (US ACHRE) on March 15, 1995
http://www.gwu.edu/~nsarchiv/radiation/dir/mstreet/commeet/meet12/trnsc12a.txt
1) Transcript of a Spring, 1997 conference presentation by survivor Claudia Mullen concerning her testimony in DC. 2) Transcripts of the US ACHRE testimonies that were presented by therapist Valerie Wolf, survivor Claudia Mullen, and survivor Christine deNicola.
http://www.whale.to/b/wolf3.html
Online videos of the US ACHRE testimonies presented by by:
Valerie Wolf, therapist – http://www.youtube.com/watch?v=gH9XHlfH0PM&feature=related
Claudia Mullen, survivor – http://www.youtube.com/watch?v=F-ES8Bv0_8w&feature=related
Christine deNicola, survivor – http://www.youtube.com/watch?v=eXDASDDrDkM&feature=related
Transcript of personal interviews by Will Snodgrass of the Chemical Injury Communication Network with Valerie Wolf, Claudia Mullen, and Christine deNicola Ebner after they presented their testimonies.
http://www.tulanelink.com/mind/interview_04a.htm
Excerpt from the video of a speech presented by President Clinton on October 3, 1995, concerning his new Executive Order 12975 – Protection of Human Research Subjects and Creation of National Bioethics Advisory Commission. (The O.J. Simpson jury trial verdict was announced on the same day and was highly publicized; whereas President Clinton’s historic speech was largely ignored in the American media.)

Woomera Prohibited Area – Government Response to Questions

January 11, 2011

martn fergusson

See earlier post on this issue.

Sellafield (Windscale) Tumor Registry

January 1, 2011

http://lifegenix.co.cc/2010/12/31/sellafield-tumor-registry/

also contains links to:
* The Children of atomic bomb survivors: a genetic study
… occurrence should be based on tumor registry data involving histological … increased risk of leukemia observed in the Sellafield study is primarily …
* HTV discovers new cluster of childhood leukaemia
The cancers include 3 cases of the very rare eye cancer retinoblastoma on Anglesey. … Wales Cancer Registry (WCR) to the Low Level Radiation Campaign in 1995. … After journalists and campaigners discovered the Seascale (Sellafield) …

* Microsoft PowerPoint – chris busby cancer
Sellafield, formerly Windscale, and the site of a serious nuclear accident in … Wales Cancer Registry, an organisation of the UK government Welsh Office. …. located the children with leukemia and brain tumours near the contaminated …
* A Review of Forty-Five Years Study of Hiroshima and Nagasaki …
all cancers occurring in people who have left the tumor registry reporting areas . Table 3. … of fathers employed at Sellafield at their conception. …
* Retinoblastoma and low level radiation
the county district that contains both Seascale and Sellafield, but whose mothers had never lived in Seascale; … cases of this tumour. In the American study, for sporadic … the National Registry of Radiation Workers is in progress, …
* Approaches to disease cluster investigations in a state health …
cluster by scanning data from the California Tumor Registry until years later, … mental source.2 The cancer excess around the Sellafield nuclear plant in …
* Brain Cancer and
Sellafield, England: A possible increase in brain cancer deaths was seen in plutonium workers when …. tumor Registry, 1993; March 1993.
* Analysis of the RB1 gene in children with retinoblastoma having …
association with West Cumbria, England, in which the Sellafield nuclear … The paediatric eye tumour retinoblastoma (Rb) occurs with an average frequency in … 29 months for unilateral cases derived from a large British registry study …
* Improvements in local infant health after nuclear power reactor …
… the only state with an established tumor registry, rose 61 % from the early …. young people near Sellafield nuclear processing plant in West Cumbria. …
* List of cancer clusters – Wikipedia, the free encyclopedia
Brain Cancer — Texas 33 (33), 477–479. … A Review and Analysis of Cancer Registry Data, 1979-1995 for Dover Township (Ocean County), New Jersey; ^ NJDHSS , ATSDR. … Seth, A. (1997) Leukemia Clusters Near La Hague and Sellafield. …