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4
Conclusions and Recorrunendations
After examining the records, analyzing the health risks, and talking with research
participants as well as researchers, the Committee concludes that in all probability the AAL
thyroid function study caused no physical harm to the subjects. As calculated in Chapter 2, the
weighted average risk among the populations that participated in the AAL thyroid function study
is about ~ In 3,000, a risk six times lower than the background thyroid cancer risk in the United
States. The greatest risks (albeit small) of thyroid cancer appear in the people who received
multiple }~3{ doses. In particular, the Anak~vuk Pass females and the Arctic Village females
who received multiple doses have calculated risks of ~ in 800 and ~ In 700, respectively.
Because thyroid cancer is rare (about 5 cases per 100,000 population annually), the additional
radiological risk is extremely low, and radiation-induced thyroid cancers caused by the AAL
study would not be expected in either the Alaska Native or white military personnel who
participated as research subjects. Some health benefits may have been coincidentally provided
because the researchers identified endemic goiter problems in Arctic Village and Anakcuvuk
Pass.
From an ethical perspective, the Committee concludes that the Alaska Natives who
participated and, to a lesser extent, the military research subjects were wronged. Although the
AAL thyroid function study was conducted according to generally accepted scientific and
medical procedures of the tunes, there was a specific violation of existing ethical standards
because information on the li3} tracer was not disclosed. Thus the Alaska Native and military
subjects were not fully informed about the nature and risks of the research. This omission was
wrong, even though the risk of harm was believed at the time to be nonexistent and has since
been determined to be extremely low.
The blurring of medical care and research activities, as well as cultural differences,
compromised the ability of Alaska Native subjects to recognize not only that Hey were
participating in research, but that refusal to participate would not harm their health. The
language barrier between researchers and study subjects in the Native villages and the use of
Native interpreters who were not scientifically trained prevented participants from gaining a
complete understanding of the research and its risks. In addition, some study subjects should
have been excluded on the basis on the basis of age or other physical conditions.
62
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Conclusions and Recommendations
63
The study's flaws are not attributable solely to the AAL researchers in the field, but are
shared by their superiors in the U.S. Air Force and the Department of Defense chain of
command who approved the research or were aware of it. Indeed, what we today identify as
inappropriate was common for the times. It should be noted that during the 1950s and later
many researchers viewed obtaining consent as essential only for obviously risk-bearing research,
because of the circumstances that produced the Nuremberg Code. However, neither the Code
by its teens nor the American Medical Association (AMA) or DOD requirements hasec! on it
.
contain such a caveat.
.. . . .
. , _ _ _ ~ ~ ..
It IS Important to emphasize that while the Committee believes it is inappropriate to place
individual blame for the flaws of the AAL study, it is essential for the government to
acknowledge that wrongs were done. The researchers were conscientious scientists who held
genuine belief, justified at the time, that their research was both harmless and Important. The
lack of emphasis on autonomy and infonned consent, and the lack of cultural sensitivity, were
standard errors of the time. It is the Committee's hope that acknowledgment of these wrongs
will reduce the likelihood of sunilar wrongs in the future.
The Committee heard repeated concerns about the history of abuse of the Native people
by the incoming white culture. In the Alaska Natives' view, the AAL study was a small but
characteristic event in the ongoing tradition of using the Native peoples for the benefit of others
with little regard for their interests. Although the Committee was limited by charge and
resources from considering this wider context in any depth, its recommendations are not
unrelated to this underlying concern. As explained in a review of the social and psychological
stress faced by veterans of above-ground nuclear testing and similar nuclear weapons-connected
events conducted by the government, there is a relationship between trust and acknowledgment
elf error ((~.~rri~ 1q`~/I n Visa>. ''r~llrh ~rPt~r~n~1
V1 `_llV1 ~V"l~l"' $~' if. and. Lowell Vat . . . must deal with the possibility that their
lives were undermined without apology, acknowledgment of error, or recognition of their service
to their country."
The Department of Energy, in a parallel activity investigating the use of human subjects
in radiation research, acknowledges the importance of dealing with past wrongs directly and
openly. As stated in a 1995 report (Deparunent of Energy, 1995~:
Over the past several decades, the American people's trust in our institutions o
government has greatly eroded. Many complex factors have contributed to this erosion, not least
among them the secrecy associated with our Cold War nuclear competition with the Soviet Union.
Without judging the historical necessity of secrecy, and in recognition that even today some
activities require national security classification, it is a fact that the ability of the Government to
perform its post-Cold War missions is greatly impeded by pervasive public distrust of its motives
and competence. The commitment to openness, of which this project is a very visible element,
is a deliberate effort to rebuild that basic level of trust between the American nec)nle and their
government that is necessary for a democracy to function.
---I- r-~r~~ ~~ - ~~~~~~
The Alaska Natives who spoke to the Committee were clearly frustrated by the lack of
communication and lack of acknowledgment. Until this Committee held its public meeting,
beliefs about how the goverrunent conducted itself had not been given a forum for expression.
As a result, Alaska Natives are dealing with unresolved burdens in regard to trust and justice.
However belatedly, the Air Force, U.S. health organizations, or the Congress could redress the
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64
The MAIN Thyroid Function Study
wrong of failure to obtain informed consent during the AAI~ thyroid function study with
information now. The ongoing provision of meaningful information could provide surviving
subjects, their families, and their villages with better understanding of the true magnitude of the
risks and possible consequences of the research. This demonstration of respect for their
autonomy and concern for their well-being could help restore a sense of control to the Native
populations over their own health decisions and hopefully increase the level of trust. The
present inquiry affords the federal government a singular opportunity to give audience to urgent
and long-held Native concerns. In this spirit, the Committee recommends the following:
(A The government and the Air Force should acknowledge responsibility for wrongs
done in the course of the ALL thyroidfunction study in the hopes of ensuring that similar
problems do not occur in the future, and they should address these wrongs by
undertaking the following actions:
(aJ The Air Force should endeavor to contact all living sublects or their
immediate families and provide records to them
v ~
of their ALL research
participation in the /~3] experiments. The Air Force should also continue to
search for records of the ALL that would identify the six U. S. Army subjects and
six Point Hope subjects who were not named in the Air Force report of the study,
and to locate the Air Force and Army subjects named in the study.
(bJ In the process of contacting subjects and subjects' families, the Air Force
should disseminate the Committee's report and other available information on
human medical experimentation conducted by the ALL in the period 1948-Z967
to appropriate health care providers, tribal governments, anal other key figures
in the relevant Alaska Native villages.
This dissemination of information could be accomplished in the six affected Native
villages by having a group of medical and ethical experts provide a briefing on the Committee's
report at a town meeting and answer questions related to the AAL research. A concise, readable
summary of such information (preferably bilingual) also should be prepared. Even though
material related to the AAL studies is available in larger Alaska public libraries, the lack of
knowledge about studies, tests, and research conducted by that goverrunent facility has haunted
participants and their families, some of whom took part in even the most benign of studies.
(2) U.S. government and Alaska state health organizations, under U.S. government
auspices, could complement the efforts of the Air Force by conducting related public
health education programs facilitated by Native experts focused on conveying information
about patients' rights in any therapeutic or research situation and medical information
about exposure to radiation. Such a process will enable Native experts, clinics, and
physicians to provide accurate information to their communities and ease fears.
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Representative terms from entire chapter:
function study
Conclusions and Recommenciatior~s
65
(3) If Congress considers legislations to redress any wrongs or harms done to human
subjects -of government radiation research where informed consent was not obtained, the
Committee believes Congress should consider including the subjects of the CAL thyroid
function study.
The last question posed to the Committee was whether or not follow-up surveys should
have been performed to ensure that the participants suffered no long-term ill effects from the
experiments and whether medical care was needed. Extending that to the present, the
Committee also considered whether medical follow-up is warranted today based on our current
understanding of the risks involved. Such medical follow-up would focus on the major negative
health effects associated with }~3} exposure disorders of the thyroid gland, including thyroid
cancer and the development of thyroid nodules. (There is no evidence of a link between }~31
exposure and skin disorders, a concern raised by some study participants at the public hearing.)
Because the dosages of radioactive iodine used in the AAL study were thought to be
hanniess at the time and there were no guidelines requiring follow-up for diagnostic doses, no
follow-up would have been indicated. In reexamining the doses of radioisotope ingested by the
research subjects, the Committee concludes that there is no justification based on risk for
medical follow-up. The risk, even among research subjects who received multiple doses, is
substantially lower than the background incidence of thyroid cancer in the United States.
(4) Although medicalfollow-up based on the calculated risk values is not warranted, the
U.S. Air Force should provide medical follow-up to those participants who were under
age 20 at the time of the ALL study since those participants will be at risk for the longest
period of time. Such follow-up would provide assurance that these participants suffered
no [ong-terrn physical ill elects.
Various laws have some bearing on issues in this study. For instance, common law provides
that governments cannot be sued by their subjects (Feres v. United States, 340 U.S.C. 135, 139 (19501~.
The Federal Tort Claims Act (28 U.S.C. v§2674 et seq. (1988~) authorizes federal liability for
compensatory damages in limited circumstances, but not when the injury results from the exercise of
discretionary judgment bv government officials an exception that has barred recovery for uranium
~ J C7 -~ ~ C7
· ~ .~ · ~ ~ Or ·, ~ m~ ~ _ ~^ ~ ~ ~ 1 ^~^ ~^.1_ an- 1 ^~\ ___ ~ lo_ ~ _ ~
miners on-tne-~oo exposure
66
The AAL Thyroid Function Study
Such follow-up should be at government expense. It might include a review of the
subjects' medical history and a physical medical examination with special attention to physical
complaints, ailments, or physiological changes or disease that could be related to the AAL
thyroid injunction study, specifically assessment of the condition of the participants' thyroids for
the occurrence of thyroid cancer or nodules. If a thyroid disease, including cancer, were to be
found, there would be no way of determining whether participation in the AAL study had any
role in causing it. Nonetheless, if thyroid disease were found the federal government should be
responsible for all expenses associated with treatment. In the remote possibility that thyroid
disease is found for those under 20, the Air Force should then reassess the issue and decide if
more subjects should receive medical follow-up.
The Committee recognizes that its basic conclusion-that the subjects of the AAL thyroid
function study were wronged but not harmed-may prove controversial. Some will claim that
the Committee's calculations are incorrect and that the risk is higher. Others will believe that
the Committee failed to go far enough in suggesting ways to right the wrongs. Some will say
that the Committee failed to understand the climate of the tunes the intensity of Cold War
pressures and national security concerns and the fact that many researchers truly did not believe
that the Nuremberg Code applied to benign human subjects research. They may claim that the
Committee was swayed by the clarity that only hindsight brings.
The Committee believes that these various perspectives arise from concern for the people
involved, both the researchers and their superiors and the research subjects. It recognizes that
some subjectivity is inherent in this type of analysis and that honest differences of opinion can
occur. Still, the Committee is convinced that its position is defensible, sensible, and ethical.
The risk analysis in this report is based on the best epidemiology and dosunetry available. It
is, if anything, conservative; risks may actually be smaller than expressed. The Committee's
position acknowledges the flaws of the AAL thyroid function study within the context of history'
while not placing blame on those who conducted the research using what they perceived to be
harmless methods in pursuit of justifiable goals.
