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1 Introduction The United States first established a significant military presence in Alaska in 1942 after the Japanese bombed and occupied islands in the Aleutians. In the late 1940s and early 19SOs, as Cold War pressures escalated, the United States feared a nuclear confrontation with the Soviet Union and the U.S. military presence in the Arctic grew. Long-range bombers, fighter squadrons, and early-warning radar stations were set up in remote corners of Alaska to prepare for the possibility of a confrontation between the two superpowers. With the Cold War looming, military planners sought to know more about how to keep fighting forces fit and capable in extreme cold and how to survive in emergencies in the harsh climate. In 1951, the Air Force established the Arctic Aeromedical Laboratory (AAL) in Fairbanks, Alaska, to conduct research on Arctic acclimatization. The U.S. Air Forcei sought information on medical problems related to cold for three main reasons: (~) aircraft were attaining higher altitudes, exposing military personnel to colder temperatures; (2) transpolar flight was becoming increasingly important, and flight crews had to know how to survive in cold and barren territory in case of emergencies; and (3) flight maintenance crews based in polar regions had to work efficiently and accurately in cold conditions. The AAL's mission was "... to conduct research and development into the human factors problems incident to U. S. Air Force activities in Arctic and Sub-Arctic regions for the purpose of increasing operational capability of He U.S. Air Force in throve regions." The AA~2 tacHed these problems win two distinct, parallel approaches: first, fundamental medical research, and second, the development and field- testing of arctic survival equipment and methods of evacuation and treatment of casualties. The AAL's mission came to include the study of natural food sources; 8 Information on the history of the AAL comes from a report of the U.S. Air Force (undated). 2The AAL was located at Ladd Field in Fairbanks, and was under the operational control of the Alaskan Air Command and its successors, but the laboratory's commanding officer also reported directly to the Surgeon General of the U.S. Air Force. The AAL ceased operations in 1967, and its functions were transferred to Brooks Air Force Base, San Antonio, Texas.

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ntrociuction 9 dietary requirements; survival aids; acclimatization to cold; and the adequacy of survival equipment, rations, and clothing. One of the AAL's research projects, conducted in 1956 and 1957, investigated the role of the thyroid in acclimatization to cold (see Box Imp. Based on previous research, including animal studies, researchers at the AAL had hypothesized that the thyroid might play a role in cold weather survival and designed a study to measure the effects of cold on thyroid activity by comparing Alaska Native subjects and white military personnel. To measure thyroid function, researchers used a radioactive medical tracer, the radioisotope iodine 131 (~3~. This tracer was developed in the 1940s to track absorption of iodine by the thyroid, its expression in the thyroid hormones in blood and tissues, and excretion by the body. It was commonly used in the 1950s (and, in fact, is still used today for certain purposes). In all, 121 people 102 Alaska Native subjects and 19 military subjects-were administered 200 doses of li3~. Based on the study, researchers determined that the thyroid did not play a significant role in human accInnatization to extreme cold; they then published their results in the scientific literature and moved on to other projects. It was not until a 1993 conference on the Cold War legacy in the Arctic that the AAL thyroid function study garnered further attention. When the shady came to light, questions were raised about the appropriateness of the activity whether it posed risks to the people involved and whether the research had been conducted within the bounds of accepted guidelines for research using human participants. In particular, there was concern over the relatively large number of Alaska Natives used as subjects and whether the research subjects understood the nature of the study. As a result, Congress asked the National Research Council (NRC) and Institute of Medicine (IOM) to conduct an evaluation of the AAL's thyroid function research project. THE COMMITTEE'S CHARGE The NRC and TOM appointed the Committee on Evaluation of 1950s Air Force Human Health Testing in Alaska Using Radioactive iodine 131 to evaluate the AAL thyroid function study. The committee was charged to address four key issues3: (~) Whether the series of medical studies was conducted in accordance with generally accepted guidelines in the 1950s for use of human participants in medical experimentation. (2) Whether the l}31 doses used in the series were administered in accordance with radiation exposure standards generally accepted as of 1957 and how those dosages compare to the radiation exposure standards accepted as of 1993. (3) Whether the studies had and followed guidelines regarding notification of participants about any possible risks. ~ l his study was authorized by Congress in Public Law 103-160, the National Defense Appropriations Act for Fiscal Year 1994 (approved November 30, 1993~. The tasks listed were assigned by Congress, although the language has been edited for clarity. !

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10 The CAL Thyroid Function Study . ... .. ~ ~ . ~ ibex ~.1 ~ ~ . . ~ ~ ~ :~ ~ ~:~ r ~= ~, IT'D r ~ ~ _ ~ ~ r' :~ . ~._., - I. ~ ~ ~:~:V::. ~ . ~ i, : :~ ~ .: . ,,,:~:~:~, .: AJAR: A,,. -~ 1. ~ :' ;3 : :~ ~ ~ ~ ~ ~ ~ ~ .:...: ~ ~ :.:: ~ ~::~ ~ ~ .: ~ . ~ ~ ~ : ~ ~ :: ~ ~ :~ ~ ~ (4) Whether subsequent studies of the participants should have been conducted to determine whether any participants suffered long-term ill effects from the administration of li3} and, in the case of ill effects, whether medical care for such effects was needed. To conduct this study, the Committee sought to examine as much written documentation as possible, including AAL historical records, results, procedures of experunents, and case files of participants and investigators. The Committee also examined historical and current literature on the use of radioisotopes for diagnosis and therapy of thyroid dysfunction and federal and professional guidelines for the conduct of human biomedical experimentation. In addition, extensive oral and written testimony was considered from those research participants and investigators who could be located. With this base of information, the Committee sought to assess the conduct of the experiments, the radiological dosage levels, and the risks to the participants. It sought to determine whether, and how, the participants were informed of the nature of the research and the usage of the radioactive isotope. Finally, the Committee considered the evolution of the concept of "informed consent" and how that concept would have been applied in the 19SOs as opposed to today's standards. The Committee recognizes the uncertainties inherent in assessing events that took place 40 years ago, but has done its best to present a complete analysis.

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Introduction ll 1 This chapter reviews the purpose and methodology of the AAL thyroid function study and introduces the Committee's methods of gathering and analyzing information. Chapter 2 assesses the medical risks from using the diagnostic level doses of the radioactive tracer and examines standards for the use of these tracers then and now. Chapter 3 considers the ethics of human subjects research, from both a 1950s and a 1990s perspective. The Committee's conclusions and recommendations are presented in Chapter 4. A selection of supporting materials is included in the appendices. THE AAL AND THE THYROID FUNCTION STUDY . ma. _ . To understand the nature and purpose of the AAL thyroid Unction study, it is important to see it in context. The AAL was conducting a broad range of studies during the 1950s to unprove our understanding of human adaptation to the Arctic environment. The researchers included both nonmilitary and U.S. Air Force doctors and scientists, and research subjects included animals, military personnel, and Alaska Natives. One laboratory project, entitled "Human Acclimatization and Adaptation to Arctic Cold," alone included 35 separate studies (U.S. Air Force, 1957b). The AAL thyroid function study, the subject of this report, was one study in this portfolio. From 1950 to 1957, the human acclimatization research was run by Dr. Kaare RodahI, a Norwegian physician and Fellow of the University of OsIo, who was recruited by the U. S. Air Force to direct the AAL's Department of Physiology, and later all of its research, because of his extensive (and relatively rare, at the time) expertise in arctic medicine. Dr. Rodah] oversaw a variety of studies on the nutrition, physiology, and living habits of Alaska Natives from villages throughout Alaska (RodahI, 1952, 1954; Rodah} and Rennie, 1957; Meehan, 1955; Drury et al., 19561. None of the studies used radioactive substances, and most were non~nvasive. They consisted of diet and lifestyle histories and the performance of physical examinations (including chest x-rays in some instances); measurements included sampling of blood and urine and analysis of diet samples. Despite the importance of its mission, the resources available to the AAL were relatively limited. Because of the AAL's remote location, obtaining specialized supplies for scientific experiments was always a problem. The laboratory's operations were also limited by transportation difficulties, the harsh clunate, and the dispersed population of interior and northern Alaska. Researchers at the AAL suspected that the thyroid gland played a role in cold weather survival. Using animal studies, researchers determined that animals exposed to cold for prolonged periods show changes in thyroid structure and function (Leblond and Gross, 1943; Leblond et al., 19441. They concluded that hyperactivity of the thyroid reflected increased metabolism in cold (Therien, 1949), and suggested that the thyroid was involved in human acclunatization to cold (Brown and Hatcher, 19531. Thus, from 1955 to 1957, the AAL conducted a study designed to explore whether the thyroid played a role in human adaptation to cold "Thyroid Activity in Men Exposed to Cold" (Rodah! and Bang, 1957~. The study used the radioisotope tracer l}3] to measure thyroid

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12 The ALL Thyroid Function Study activity. The medical subjects were Alaska Native men and women in a number of villages of northern and central Alaska, and Air Force and Anny servicemen. In the research, capsules of radioisotope Ti3i were administered to Inupiat Eskimos, Athabascan Indians, and U. S. Air Force and Army personnel. The levels of radioiodide uptake in subjects' thyroid, blood, urine, and saliva was measured by scintillation (radioactivity) counters in the field and laboratory. Additional information was obtained through clinical examinations and by measuring blood cholesterol, dietary iodine uptake, and basal metabolism. To evaluate the effects of different levels of cold exposure, the study was conducted in different seasons of the year for Alaska Native subjects, and before and after exposure to cold stress with U.S. Air Force and Army subjects. The goal was to provide a picture of thyroid activity and its relationship to metabolism in the different racial groups exposed to cold. This study included six different tests and lasted from August 1955 to February 1957. Dr. Rodahl received standard training on how to handle and administer li3i, and how to measure its uptake, retention, and excretion in humans. After obtaining the appropriate laboratory equipment for the project and approval from the Atomic Energy Commission for the use of the radioisotope, he instructed Dr. Gisle Bang and other AAL physicians in the experimental field and laboratory procedures. A total of 200 doses were distributed in preformulated pharmaceutical capsules. The stated maximum doses of Ii3i for individuals given was 65 microcuries.4 However, the usual dose was less, ranging from IS to 50 microcuries, with most being 50 microcuries as was standard for radioiodine tracer studies of the time and as approved by the Atomic Energy Commission. Doses below 50 microcuries occurred, however, because of the natural reduction of radioactivity in the prepared capsules that occurred during the long transport time involved in shipping them to Alaska. (The researchers attempted to compensate for the lower does by using longer scanning times in the field, but those results were judged to be unreliable.) Although relatively good records of the study, including names of most subjects, were kept, some data were incomplete. Records of actual dosage for each subject during each trial were provided inconsistently in the physician's report. CONDUCT OF THE STUDY: SAMPLE SIZE AND DISTRIBUTION Alaska Natives _ The first }~3i tests took place in the coastal Inupiat villages of Wainwright and Point Lay during August 1955. The inland Inupiat village of Anaktu~ruk Pass was visited in September, and the Athabascan Indian villages of Fort Yukon and Arctic Village were visited in October 1955 (see Box 1.2~. Later in the study, AAL physicians made return visits to most villages and tested 46 subjects again to compare seasonal differences in Ii3' uptake. AAL doctors revisited Wainwright in February 1956 and the other villages except for Point Lay, which was not 4The microcurie (,uCi) is a unit reflecting the level of radioactivity. One curie is equal to 37 billion disintegrations per second; 1 ,uCi is one millionth of a curie and is equal to 37,000 disintegrations per second. Higher ,uCi values indicate greater radioactivity.

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Introduction ~.~ ~ ~ I: -. At. off :..' 0) ..'~-;TMi~- ~; ~ ~ ~ ~ When A - acts ~ed~at~ - es ~ A: flus', " At; ~ ~people:in~:ibestudy;*om~l~=a=, l957)'~ ~ ~ 10 ~1 1u minis anti WeD: ~m~fc lbe Lay Point Hope,: ~ ~ - warm ~1~ ~ - ~ ~..-..pos~....~t,~ ~.~ -. ....... ~. , ~ ... - .. ~ ~ ~ .~ ........ it,. .4 ~.~' ... ~ ~.~ i.. i. i, .- ..- ij::

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14 The AAL Thyroid Function Study revisited, in March 1956. A third trip was made in July 1956 to Anakruvak Pass and Arctic Village, which were involved in a control experiment on potassium iodide uptake. Point Hope, an Inupiat coastal village' was visited only once late in the study' in February 1957. A total of 76 men and 26 women, including women of childbearing age and some women who were lactating and one who was possibly pregnant, were subjects of the study. Ages of Alaska Natives in the study ranged from 16 years to 90. Table 1.1 provides a breakdown on the numbers of subjects, their gender and age distributions, and maximum (cumulative) radioactivity admin~stered.5 Army and Air Force Servicemen A total of 19 white servicemen were subjects in the shady. Nine airmen and ten infantrymen were recruited from the military units in Fairbanks (K. Rodahl, personal communication, 1994). The first doses of radioisotope were given in September 1955 to four infantrymen and in October 1955 to four airmen. Measurement of thyroid uptake of radioiodide took place over a one-week period. Another group of five airmen was tested in the fall of 1955, and then again in February of 1956 following one month of field experience in the cold in unheated shelters. The second test of the first eight subjects took place in February and March of 1956. A third group of six infantrymen were given similar tests in October 1956 and February 1957 as a comparison sample to the Point Hope subjects. The U.S. Air Force subjects were all males and ranged in age from,l9 to 37. The maximum activity of li31 they received was 36 microcuries. For the Army i~an~men, Me age range was 19 to 26, and the maximum activity of Ii3i given was 125 microcuries-the total dosages received by the six unidentified soldiers from the last test of 1956-1957. Table 1.2 provides basic information about the servicemen, their ages, and maximum activity of lilt received. CONDUCT OF TED STUDY: SUBJECT SELECTION The U.S. Air Force did not have guidelines in place requiring written consents in human experimentation, so AAL physicians did not obtain signed consent forms. According to Dr. Rodahl (written communication, 1994~: iAAL Technical Report 57-36 (Rodah} and Bang, 1957, p.2) states that there were 120 participants "19 whites, 84 Eskimos, and 17 Indians." This does not match the counts in Tables T. IT, Ill, {V, V, and XXIT! of that report showing test results from 121 participants. 6Information included in this section is based on testimonial information, correspondence, scientific reports of the time, and personal interviews. A more detailed evaluation of consent issues appears in Chapter 3.

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introduction TABLE ~ . ~ . Alaska Native subjects of the AAL thyroid Unction study by village 15 Number of Number Number Number AAL Highest Its' VILLAGE of of of Age Trips to Activity in ,uCi Subjects Men Women Range Village Wainwright 47 39 8 20-70 2 71 Point Lay 12 7 5 16-90 1 16 Anaktuvuk Pass 20 13 7 21-76 3 129 Fort Yukon 6 6 0 2140 2 58 Arctic Village 11 5 6 17-67 3 130 Point Hope 6 6 0 19-28 1 54 TOTAL 102 76 26 16-90 SOURCE: Rodahl and Bang (19571. TABLE I.2. Military subjects of He AAL thyroid function study Number of Highest }~3] Service Number of Tests per Activity in Subjects Age Range Person loci U.S. Air Force 9 19-37 2 36 U.S. Army 10 19-26 2 125 TOTAL 19 19-37 SOURCE: Rodahl and Bang (19571. At the time of these studies [1955-1957] there was, as far as ~ know, no question of written consent. As a matter of fact, a number of our [N]ative subjects could neither read nor write. In the case of the [N]atives, we went to the leader of the group in question. . . and explained our proposed study and its purpose to him. He then talked to his group and came back to us with the subjects who had volunteered to take part in the study. Our studies were known to our medical colleagues, both military and civilian, and members of the Alaska Native Service ....In several cases they helped us with the initial contact with some of the [Nlative groups. Furthermore, our studies and the reports of our results were approved by the Head of the Arctic Aeromedical Laboratory . . .

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16 The ALL Thyroid Function Study The one military participant in the AAL study who spoke to the Committee did not recall signing a written consent form, although he did recall being briefed on the project and being asked if he wished to participate. Generally, in the Alaska Native villages studied researchers approached village elders, explained the proposed research, and asked for help securing volunteers. Medical screening, basic care, and supplies were sometimes provided. Physicians gave the elders information about what they wanted to do and explained their need for volunteers. In turn, the elders recruited potential subjects. The explanations given by elders to potential volunteers in this recruitment process apparently were unwitnessed by the researchers. The elders' capacity to understand ~ ~ Thus, the Because there is no term for AIL ~ English and scientific language varied considerably from village to village. information conveyed to subjects could have varied widely. "radiation" in Alaska Native languages, it is not clear that full and accurate information about the study could have been conveyed to non-English-speaking subjects in any event. It does appear that Dr. Rodah} and colleagues communicated directly with subjects during the testing, at times through interpreters, to explain such things as what the subjects should do and when they should come back for more tests. He stated that the subjects who were brought to hen were given the right to refuse to participate and that no one refused. This approach to working with Alaska Natives is consistent with other AAL practices of the 1950s (RodahT, 1962, p. 30; Hopkins et al., 195S, p. 122), in which a local elder was used to brief villagers or the village council on the research and give instructions. Local messengers would bring villagers to the makeshift clinic. In return the AAL physician would also run a clinic to treat illnesses in the local population. Results of the experunents generally were not conveyed to the subjects, only to the scientific press and colleagues, which presumably also included the Alaska Native Service doctors. Wainwright In Wainwright, a villager who is now an elder reported that he acted as the intermediary and interpreter for the AAL doctor in the 1950s medical study. During that period, Wainwright was a village undergoing a process of acculturation and had about 225 people who lived in 35 sod and wood frame houses (Milan, 1962~. The elder (who was under 40 years of age at the tune) was the chair of the village council and spoke English as a second language. The elder had obtained a vocational school education in Oregon in the 1940s and told the Committee that the physicians did not speak Inupiat. When the doctor said he wished to conduct a study and needed individuals from the village to participate, the elder discussed this request with the village council, which agreed to allow the AAL physician to conduct his study. It is unclear whether the elder received a complete explanation of the nature of the study, its potential risks, or the use of radiation in the study. He stated that the word "radiation" was never mentioned in connection with the use of the li3i capsules, and that he thought the capsules were to improve the villagers' health.

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Introduction 17 Individuals7 chosen by the village council in Wainwright were told by messengers in the village to come to a schoolhouse where they were to see physicians. None of the eight participants to whom the Committee spoke could remember receiving an explanation of the experiment, or being told they could refuse to participate. The village participants were asked about their ability to speak English at the time; while some said they had a rudimentary knowledge of the language from the local school, others said they did not. Anakfuvuk Pass . . . The inland village of Anaktuvuk Pass was a community of 78 nomadic Inupiat Eskimos living in a collection of tents and nine houses who followed game, principally caribou, across the Brooks Range mountains and elsewhere in the interior of north central Alaska (Rodah! and Bang, 1957; Laughlin, 19571. In Anaktavuk Pass (and later Arctic Village), the AAL doctors encountered a health problem that had an impact on their research: endemic goiter. Goiter is indicated by swelling from an enlarged thyroid at the base of the neck. It is caused by insufficient intake of iodine and it is readily solved in our society by the use of iodized salt (see Box I.3~. The AAL doctor who visited the village reported that "16 of 27 persons above the age of 17 had definite thyroid enlargement." In mid-1956, the AAL doctor reported that three residents of the village were taken to Anchorage for thyroidectomy operations for goiter "since 1955" (RodahI, 1957) or "by 1955" (Rodah! and Bang, 1956b). According to the five study participants from the village with whom the Committee spoke, the occurrence of goiter in the community was used in the description of the procedure by the AAL physician when the medical study was explained to the participants in the 1950s; however, the term "radiation" was not explained in connection with the experiment. Some people from the village did not participate in the initial tests of September 1955 (it was said that they, or their families, were out hunting). Yet when the physician came back in March 1956, these people were included as subjects in the subsequent test, despite the fact that they would not have provided a before and after winter exposure for the purpose of the thyroid study. In contrast to Wainwright, one participant from Anakravak Pass recalled being offered the opportunity to refuse to participate, but agreed to the study because he believed he would benefit from doing so. Dr. Bang recalled that he had informed an elder at Anaktuvuk Pass and 70ne woman became part of the study despite the fact that she had an enlarged thyroid at the time. Although not given a subject number for further trials, she was givenIl3l apparently to study its uptake in a diseased thyroid. She was unable to recall the study, but told us she had a thyroidectomy in possibly 1959, four years after the ohvsicians came to Wainwri~ht. The Committee did not attempt to verify her medical history. ~-r- -A ~ The North Slope Borough's Department of Health and Social Services provided information that 20 of the 48 participants from Wainwright were still alive. For the other villages they said that 4 of 12 subjects from Point Lay were still alive, and ~ of 20 subjects from Anaktuvuk Pass were still alive. i

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The CAL Thyroid Function Study the director of the private hospital in Fort Yukon about the study and explained the purpose to the participants, who were selected "on a voluntary basis" (written communication, 19941. Fort Yukon Fort Yukon, an interior Alaskan village of Athabaskan Indians with a population at the time of between 400 and 500, was the location of a private hospital (Rodah! and Bang, 1957, pp. 20-21~. At that location in October 1955, six men were selected for the study. Some participants were employed at the Fort Yukon Hospital at the time; some, in fact, participated

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introduction 19 in previous and subsequent experiments by the AAL doctors (R. Balaam, oral communication, 1994). As in visits to the other villages, the word "radiation" was not used by the AAL doctor in connection with the experiment. The participant with whom the Committee spoke said he spoke English at the time and understood the term, but it was not mentioned; he said he took part because he was curious about what they might do. Arctic Village During October 1955 and March and July 1956, AAL doctors visited Arctic Village. At the time, the village was a part-tune settlement of families of Athabaskan Indians in the interior of Alaska who mostly were subsistence hunters living off caribou and other game (Rodah! and Bang, 1957; RodahI, l956~. The village was one of the very last to be visited by white . . . . . The families traveling together were ClV1 Nation, ant at t. he time no one spoke L;ngllsh. ~ ~ approached by the AAL physician, who landed by small airplane, but it is not known how communication was established or information provided on the thyroid test. Eleven villagers were tested, although not all were present when the doctor arrived each time. The daughter and son of the village chief told the Committee that they spoke no English at the time and all they could do was nod at the doctor. Rodah] and Bang (1956a) reported that in April 1955, four cases of goiter had been found in the population, and by mid-1956, 9 of the 50 Indians had enlarged thyroids. Two Indians had been transported to Anchorage for thyroidectomies since 1955 (Rodahl and Bang, 1957~. Arctic Village and Anakfuvuk Pass were chosen by the AAL doctors for a control test using a potassium iodide supplement to determine whether increased }~3} uptake was related to endemic goiter or might be related to thyroid stimulation from exposure to cold. In the test, four of the subjects from Anakruvuk Pass were given 0.6 milliliters of potassium iodide daily for three months, after which their thyroid uptake of li3} was tested; five other village members were not given the supplement before their retest. In Arctic Village, two subjects were given the supplement after their first thyroid test and four others were not. The subjects do not recall being told why they were given the supplement, but the supplement ended after the doctors completed their control studies in 1956. The subjects receiving the dietary supplement showed a significant drop in iodine uptake in the follow-up }~31 testing. The doctors also performed a nutritional analysis for Anak~uvuk Pass and Arctic Village and found an inadequate intake of iodide in the salt, food, and water supply. On the basis of this work, they concluded "that the observed deviation from the normal in the iodine metabolism in the inland Eskimos and Arctic Village Indians is a manifestation of endemic goiter and cannot be taken as an indication of the effect of cold exposure on thyroid function" (Rodah} and Bang, 1957), the chief reasons being lack of access to marine food and the use of unionized salt (Rodahl and Bang, 1956a). Point Hope In February 1957, six men from Point Hope were tested for their thyroid iodine uptake to see why after 24 hours after the tracer dose, blood content of li3} was lower in Natives than !

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20 The ALL Thyroid Function Studly in whites and lower in the winter than in the summer. The subjects were tested once in comparison with a group of six infantrymen. Unfortunately, the names of the 12 subjects were not recorded and the Committee was unable to locate any AAL archive records that might have included such data. A semiannual report of the AAL (U.S. Air Force, 1956b) stated that Dr. Bang was the only AAL physician who visited Point Hope in 1956; the same report also mentioned the selection of test subjects for the 1957 thyroid study. The Committee could not tell who tested the infantrymen, except the Committee does know that Dr. RodahT had left Alaska by that time. Military Testing In September to October 1955, volunteers were sought by Dr. RodahT from the Air Force and Army enlisted men stationed in Fairbanks. The method used, according to Dr. RodahT, was a request to the commanding officers, who then made an announcement requesting volunteers. Volunteers were told the nature of the experiment. According to the report, four Army infantrymen and nine Airmen, including four volunteers from the AAL, were tested initially for }~3] uptake including saliva, urine, and blood samples over four days after basic weight, height, age, pulse, and blood temperature readings were made. In a follow-up, the volunteers were tested again during February and March 1956. In addition, volunteers who were to spend one month in January 1956 on field maneuvers in the cold without benefit of warm shelter were tested for thyroid activity before and after the field maneuvers. The one participant with whom the Committee spoke did not remember specific details about how he was infonned of the experiment, nor did he remember taking the iodine tracer capsules. He did remember the cold weather maneuvers, in which he stayed outside for a winter month near Fairbanks with only unheated shelter; during that period he also participated in other experiments related to survival in cold weather. A second experiment using six (not named) infantrymen took place in the months of October 1956 and February 1957. STUDY RESULTS The AAL thyroid function study concluded there was no significant difference in thyroid uptake or urinary elimination of radioactive tracers in the Natives and whites tested. Nor was there any indication of increased thyroid stimulation as a result of exposure of the subjects to cold. The AAL study (Rodah} and Bang, 1957) concluded there was no racial difference in the uptake or excretion of }~31 and protein-bound {~3i, and no consistent seasonal difference either. The increased uptake in li31 in inland Inupiat Eskimos and mountain Athabascan Indians was attributed to iodide deficiency in the diet in these populations. As a result of the winter field exercises for military subjects, no evidence was found of increased thyroid stimulation. The thyroid, the doctors concluded, did not play a significant role in human acclimatization to the Arctic environment.

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Introduction 21 The military continued to investigate the role of the thyroid in acclimatization to cold. In Alaska in the 1960s, at least one more AAL study using military volunteers, and possibly another by the Naval Research Laboratory, 9 was conducted. Over time, some relation was discovered, but not until techniques were improved. As described in Appendix A "Thyroid Function in Health and Disease," subsequent research identified what was named the "polar T3 syndrome" (Reed et al., 19901. In white men who lived in Antarctica for more than five continuous months, Reed, Brice, and colleagues (199Oa) described increased production of thyroid hormone T3, as well as increased metabolic clearance and increased serum binding indicating a more efficient use of the T3 hormone in the body in response to cold. Another discovery of thyroid-related response to lengthening daylight correlated production by the pituitary of thyroid-stimulating hormone (TSH) and cholesterol in the blood (Tkachev et al., 19911. (Levels of TSH and the thyroid hormone T3 in the blood increased while levels of hormone T4 and cholesterol decreased with the lengthening of daylight duration.) A review of data from tables in the Rodahl and Bang study (1957, pp. 49, 73) demonstrated the T3 effect, in that retention of the }~3} was greater in human subjects after exposure to winter climate. The experiments conducted from 1955 to 1957 concentrated on examining racial differences of iodine uptake in the thyroid. By not noting the decreased excretion of iodine in their winter expenments, the physicians failed to understand that the human body was more efficiently using thyroid hormone. Blood analysis techniques were not sophisticated enough at that time to measure the endocrine secretion levels. THE COMMITTEE'S METHODS The experiments at issue here happened 40 years ago, so reconstructing the events of the research and locating the researchers and subjects was a formidable task. The effort consisted of a detailed historical records search, requests for assistance from local, tribal, state, and federal agencies and governments, telephone and personal interviews, written interviews utilizing a questionnaire, and a public hearing. The Committee focused on gathering information on the conduct of the medical study and did not conduct physical examinations of the study participants nor review their medical histories, although that information was volunteered in the testunony of some participants. The Committee did attempt to contact all subjects of the study, but address changes, the death of some participants, and lack of pertinent information either in the original AAL report or in Air Force records prevented the Committee from locating all participants. At times, the Committee had to rely on anecdotal evidence because this was all that was available. PA report of a meeting found in the archives of the University of Alaska, Fairbanks, provided details of an experimental protocol to be carried out by the Naval Arctic Research Laboratory in Barrow from November 1967 to February 1968. The study would have examined uptake, retention, and excretion of Ills after exposure to cold weather by 12 Wainwright Natives. The Committee could not determine, however, whether the study was ever carried out. 1

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22 Written Information The CAL Thyroid Function Study To conduct this evaluation, the Committee needed as complete a written record as possible of the experimental procedures. Documents used included copies of technical reports of the AAL, semiannual histories of AAL activities, and approval documents by the Atomic Energy Commission for the conduct of the AAL research. Using those materials as a start, the Committee requested a search by the Air Force and the National Archives for AAL internal approvals for experimental design and conduct of the experiment, memorandums, reports, or orders for the physicians and support personnel to fan out across Alaska to conduct the study, orders or voluntary assignments and personal waivers for enlisted personnel to participate in the study, and interim and final reports to Air Force personnel from the period of the study. The records search was conducted in the archives and libraries at Brooks Air Force Base, San Antonio. Texas; Boiling Air Force Base, Washington, D.C.; Elmendorf Air Force Base, Anchorage, Alaska; Maxwell Air Force Base, Montgomery, Alabama; Wright-Patterson Air Force Base, Columbus, Ohio; and the Deponent of Defense records center in Alexandria, Virginia. The documents search also was conducted by archivists at the National Archives regional centers in Anchorage, Alaska; Seattle, Washington; St. Louis, Missouri; Washington, D.C.; and Suitland, Maryland. No records of the AAL prior to 1958 were located. 7 ------= ~-7 Interview and Public Hearing Information The written documentation available was not adequate to provide a complete picture of the AAL thyroid function study, particularly in regard to the consent process, the day-to-day functioning of the AAL at the tune, and the participants' understanding of the nature of the study (both researchers and subjects). To obtain further elaboration on the methodology and conduct of the experiments, the Committee sought personal accounts from participants in the research. The Committee had help from various sources in locating participants. Using information from AAL records, which listed all but 12 of the experimental subjects, the North Slope Borough's Mayor's Office identified subjects in villages under its jurisdiction and shared that information with the Committee. The Tanana Chiefs' tribal organization did the same for Athabascan Indian villages in central Alaska. Service. Some information was also provided by the U.S. Indian Health On July 5, 1994, a member of the Committee (Dr. Baines) and the NRC study director met and interviewed eight Alaska Native participants of the study in Wainwright, Alaska, and a village elder who had acted as the intermediary for the AAL physicians; three of the eight did not remember the research. On July 6, they interviewed six Alaska Native participants of the study in Anaktavuk Pass (one did not remember the research). In the trips to the two villages, the North Slope Borough's Mayor's Office provided an Inupiat translator with a medical background to assist in translating questions and responses from subjects who spoke no or limited English, and a special assistant who knew the house locations of the experunental subjects. Two subjects from Fort Yukon were reached by telephone, but could not remember the details of their participation.

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introduction 23 The Committee then hosted a two-day public information-gathering session, July 7 and 8, 1994, to gather first-hand information from as many participants as possible. Several witnesses were identified in advance and asked to speak during the session. Because of tune and distance constraints, some witnesses unable to travel to Fairbanks provided their testimony by telephone conference call. Interested members of the public were also invited to Provide information. ' ' ' ' ' ' ' ' ~ '' Almougn not mended as an eplaemlologlca1 rollow-up, the Committee used a mailed questionnaire to seek responses about the conduct of the experiment from the known subjects who were not interviewed in their villages, over the phone, or at the public session by the Committee. Speakers knowledgeable on the subject of medical practice and health concerns in Alaska in the 19SOs and the 199Os also were identified and asked to make presentations on State of Alaska health concerns and programs (of the 1950s or 199Os or both, depending on expertise), scientific and ethical concerns regarding human medical experimentation of Alaskans and military men during the period of the Cold War, and the }~31 studies in particular. Some former employees of the AAL during the period 1955-1957 were asked to speak on the working conditions and organization of lab and about the state of medical practice in local communities, the relationship between the Alaska Native Service and the staff of the AAL, methods used to get military and Native volunteers for medical studies, what guidance on informed consent may have existed in the AAL at that time, and what they could remember about the AAL studies. This background information helped the Committee understand the day- to-day function of the AAL in the 1950s time period. Subjects of the experiments were asked a standard list of questions about how the study was done; how they were picked to be in the study; what they were told by the Air Force doctors before, during, and after the study; if the doctors spoke with village elders or the witnesses (or their parents if they were very young) to get consent to do the study and what they said to them; if they were told there were any possible ill effects that might be suffered from participating in the study; and if the researchers or other doctors from the Air Force or the Alaska Native Service saw the subjects after the study was completed or gave any medical care as a result of the subjects' taking part in their study. These questions were included in a letter sent to each potential witness and an announcement sent to the Inupiat villages. In addition, a public announcement of the public session was provided to press sources in Alaska to seek additional witnesses who might come forward to offer relevant testimony. The Office of the Air Force Surgeon General was able to provide addresses for a very few of the military experunental subjects; NRC staff sent these individuals a letter and attempted to reach them by follow-up phone call. Unfortunately, only one of the 1 3 named in the AAL study report could be reached. This person participated by phone and was asked basically the same questions as the Native participants, except he was also asked about the process of military volunteering and consent. Information was gathered from Dr. Rodah! and Dr. Bang via telephone calls, correspondence, and a telephone conference call with the Committee during the public session. They answered questions on all phases of the 1950s experiments. Details from the public session appear in Appendix B.

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24 1 - In confusion about the i]5] experiment and other medical experiments conducted in the region through time, as well as confusion about a host of Arctic contamination issues. During the public session, it became clear that many of the speakers were concerned about experunents beyond the AAL thyroid function study other medical experiments conducted at other times and places. Some speakers raised concerns about unrelated, but obviously important, issues such as unresolved Arctic contamination from the military presence. Some spoke with alarm about reports of radioactivity in the Arctic Ocean from dumping waste materials such as sunken nuclear reactors from the former Soviet Union. Questions were posed about other radioactive elements besides }~3i, including strontium and cesium.~ For some, the public session was seen as an opportunity to air grievances that had no forum before. Participants fez fear, anger, and uncertainty about the role of 173' and other contaminants in producing various chronic ailments and even death. Some of the Alaska Natives who testified believed that Native people seemed healthier long ago and that health difficulties seemed linked with the rapid and sometimes dramatic changes caused by increasing domination by Western culture that began in the 1940s. Again, this concern is not directly related to the AAL thyroid function study, but is important to our understanding of the people's feelings about the study. It is impossible to disentangle completely the people's reactions to other research that was conducted and other aspects of their contact with the incoming dominant culture and the changes caused in their traditional lifestyle. Participants in the public session expressed great frustration and increasing militancy about the lack of respect given Native people by the Western majority. Throughout the public session, speakers voiced frustration that Native people repeatedly had been betrayed by white authority figures and that these betrayals freauentIv followed extensions of hosnitalitv. respect. The CAL Thyroid Function Study COMMON THEMES FROM THE PUBLIC SESSION The public hearing and interviews were free of obvious rancor and reflected a real willingness to cooperate and share information with the Committee. All the participants, but especially the Alaska Natives, were exceedingly generous in their attitude toward the Committee's mission and their willingness to be of help, even at great personal expense (financial and emotional). The advantage of such interchange was that it permitted the Committee to gain insight into what really occurred and what the participants thought and felt. The Committee heard the following common themes during the public session: Participants in the AAL thyroid function study and the Dublic in Alaska share a general . ~ ~ , ~, . . ,, a __~ ~ __ --a ~ - ~ ~ - -- - - - - - - - --- - - --- - - -- - - ------ -J 7 - - -r - - ~ . . ~ ~ . . ~ ~ ~ . ~ . . - ~ ~ ~^ and trust Dy Native peoples. AS evidence Of disrespect, speakers cited the OOVlOUS lnOlllereIlCe and ignorance of whites about the Native government and social structures, and about Native philosophy of life. White arrogance was characterized by a persistent presumption Mat whites 1 ~ ~ - - -A - ~ ~ a- - r ~ believed that Natives wanted to be lake us. the tension between the cultures was clear when one participant asked the AAL principal investigator if he thought Natives were human. Some 'Atmospheric testing of atomic weapons by the U.S. and the former Soviet Union in the l950s and 1960s resulted in some accumulation of nuclear fallout in Alaska. This matter was still brought up as a problem by testifiers at the Committee's hearing. Although this was not the focus of the Committee's efforts, several studies such as those of Hanson (1967, 1971, 1982, 1994), and Stutzman et al. (1986) have addressed this matter and found that the fallout did not result in cancers in local Alaska populations.

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Introduction 25 speakers, and even the Committee, were chastised for being insufficiently attuned to, or carelessly informed about, how different were the needs and concerns that distinguished the Inupiat Eskimos from the Indians. Participants pointed to who benefitted from the research as another example of white arrogance the experiments on Natives were performed not to help the subjects or to help their general society, but to help the U.S. military and the general welfare of whites. When given this opportunity to voice long-held frustrations, a theme was that the research epitomized white entitlement at the expense of Native respect and trust. Participants doubted the willingness of the U.S. government to share information and wondered whether even this attempt at openness was half-hearted. With hindsight, the secrecy ethos of the Cold War era did much to breed mistrust of government, not just in Alaska but throughout the citizens of the nation. The Alaska Natives' strong response to learning of the AAL thyroid function study was born out of years of mistrust, a mistrust that will not be simple to rectify. To the interested parties it may have seemed peculiar that there is not a larger and clearer paper trail about the research subjects. Participants in the public session expressed frustration at how difficult it has been for them to obtain archived inflation. Even this Committee was suspect was it part of an overall "stonewalling" effort because it was unable to supply names of some individuals who participated in the }~3{ experiments? Further, some were dissatisfied because of the short notice given about the Committee's public meeting; this problem was due to time constraints but could be interpreted as an indication of insincerity. Participants also were distressed that the Committee did not visit every concerned village and that not all members had visited villages; this constraint was also due to time and financial limitations. Over and over again, speakers voiced concern about the history of abuse the indigenous people have suffered from the dominating mainland culture. From the Natives' viewpoint, their grievances have been met with at best patronizing indifference and at worst lethal disregard. Although not specific to the AAL thyroid function study under investigation by this Committee, these concerns are reactions to the larger context within which the study took place, a context which has implications for the nature of the conduct of the study.