Darkness in El Dorado - Archived Document
Elements of the Professional Life of James V. Neel as Reflected in the
Declassified Literature on Human Radiation Experimentation
Barbara Rose Johnston
Senior Research Fellow, Center for Political Ecology,
P.O. Box 8467, Santa Cruz, California, 95061
Review of the Atomic Bomb Casualty Commission Archives materials relating to James V. Neel. Archive: National Academy of Science, 2001 Constitution N.W., Washington DC
Archive Review Date: March 14, 2001. Review of Department of Energy Human Radiation Experiment files relating to James V. Neel, Marcel Roche, and other biomedical research projects sponsored by the AEC. Online Archives: < http://hrex.dis.anl.gov > and < http://worf.eh.doe.gov >. Archive review dates: periodic review between September 21, 2000 and April 10, 2002.
Efforts to authenticate or disprove allegations in Patrick Tierney's Darkness in El Dorado have generally relied upon reviews of publications, field notes, grant proposals, and related materials contained in James V. Neel’s personal archives in Philadelphia and Houston, and various records at the University of Michigan. See for example, the ASHG Commentary "Response to Allegations against James V. Neel in Darkness in El Dorado, by Patrick Tierney" in Am. J. Hum. Genet., 70:1-10, 2002; Susan Lindee's "James V. Neel’s field notes in 1968" November 2001 paper presented to the American Anthropological Association < http://ccat.sas.upenn.Edu/hss/faculty/James V. Neel.htm >; John Stevens and Terence Turner's "Annotated index of selected documents and correspondence from the collection of James V. Neel’s papers in the archive of the American Philosophical Society " < http://www.anth.uconn.Edu/gradstudents/dhume/darkness_in_el_ dorado/index.htm >; Terence Turner's "Turner on Turner* on Turner, Point by Point by Point: A Rejoinder to Trudy Turner and Jeffrey Nelson, Turner Point by Point" posted on web page of El Dorado Task Force of the American Anthropological Association < http://www.aaanet.org >; and, Trudy Turner and Jeffrey Nelson's "Turner point by point" < http://www.aaanet.org >. These materials reflect the nonclassified facets of Neel's professional life-- those documents, data and correspondence associated with academic and scientific pursuits that have little direct relevance to questions of national security. At the time of Neel’s retirement, at the time when he was preparing his published memoir, and at the time he was selecting materials to house in his personal archives, many of the documents pertaining to his Atomic Bomb Casualty Commission (ABCC) and Atomic Energy Commission (AEC)-related work were still classified.
This paper represents a summary of aspects of the private dimension -- that part of Neel's professional life that was conducted in secret and remained secret (classified) throughout his entire life. I conducted this review with the hope of addressing two key questions: Why was the Atomic Energy Commission funding James V. Neel's work with the Yanomami; and, what relationships existed between the Yanomami research and previous work by Neel with the Japanese and Marshallese populations? Adequately addressing these questions requires examination of the recently declassified literature.
Sources for this paper are drawn from a review of materials written by James V. Neel or include reference to Neel, housed in the Atomic Bomb Casualty Commission (ABCC) archive at the National Academy of Sciences, Washington DC. Materials in this archive include previously classified correspondence, research proposals, interim and final reports, and papers, presentations, and publications resulting from ABCC-funded work. Neel-related references were identified by accessing the online index for the ABCC archive and searching for the key term "James V. Neel." Files were also examined with key terms "Yanomama, Yanomami, Venezuela, Brazil, and Marshall Islands." Photocopies were made of all documents that addressed, at one level or another, questions relating to Neel's work with the Yanomami. These materials are referenced in text according to the National Archives ABCC box number and file name.
This review also draws from recently declassified documents contained in the Department of Energy's Human Radiation Experiment archive ( http://hrex.dis.anl .gov) and their archive of the Nuclear Weapons Testing Program and related human subject experimentation in the Marshall Islands ( http://worf.eh.doe.gov ). Files were examined with key terms of James V. Neel, Marcel Roche, consanguinity, Brazil, Venezuela, Yanomami, and Yanomama. All documents retrieved in these searches were downloaded, and physical copies printed. These materials are referenced in text with the website address -- allowing any reader to access the document in question.
To assist the reader who is unfamiliar with the history of science during the Cold War. I provide brief summaries of the ABCC, the Atoms for Peace Program, and AEC in an appendix to this paper. These historical summaries are directly pasted from, or abstracted from U.S. government websites.
James V. Neel: Summary From Document Reviews
The review of the ABCC material provided an opportunity to track James V. Neel's initial "field" research experience, examine research questions and protocols in Japan, recognize the political economic constraints influencing his long term access to research data, and identify possible reasons for his move to the Amazon as a major focus for long term research efforts. These documents suggest that Neel's 1940-1960's era research primarily involved the goal of understanding natural mutagenic processes to better interpret environmentally induced (radiogenic) processes. Understanding what he was doing with the Yanomami (and why the AEC was funding Chagnon's research) requires addressing related research efforts with the Japanese and Marshallese populations.
The ABCC was set up to study the human effects of radiation exposure from atomic bombs in Hiroshima and Nagasaki, and James V. Neel was the Acting Director for Field Studies (1947-1949) where he set up the research program. Neel had both a Ph.D. (serving as a fellow in Zoology at the National Research Council 1941-1942) and a M.D. (serving at Strong Memorial Hospital 1944-1946). In 1948 Neel was hired by the University of Michigan as Associate Geneticist in the Lab of Vertebrate Biology and Assistant Professor of Medicine (1948-1951). From 1951-1956 his University of Michigan title was Geneticist in the Institute of Human Biology. From 1957-1985 he was Chair and Lee R. Dice University Professor of Internal Medicine. He became Professor Emeritus in 1985.
James V. Neel was a part of the National Research Council group that first surveyed effects from atomic bombing in Japan in 1946. He came to this position with some experience in researching the impact of radiation, as he was one of many scientists who worked on classified projects during and immediately after World War II. (See for example the lab report of a white male, age 66, injected with plutonium in 1946, dying on July 2, 1947, located through a “Neel+plutonium” keyword search of the human radiation experiment archives. Hand written notes on the report suggest James V. Neel analyzed changes in blood after plutonium injection. < http://hrex.dis.anl.gov/tiffs/d728297/d728297a/28319002.tif >).
In the spring of 1948, the Atomic Bomb Casualty Commission was established with an initial purpose being to determine the outcome of all pregnancies then occurring in Hiroshima and Nagasaki, and in a control city, Kure located some 18 miles from Hiroshima. James V. Neel was appointed Acting Director of the Field Survey Program in Japan (1948-1949), where he served as the primary architect of a nascent research program meant to document the human effects of radiation. He organized a system of pregnancy registration and reporting, developed research protocols to allow detailed follow-up studies upon the termination of each pregnancy, and developed a system of coding to analyze data with the goal of discerning what conditions and outcomes might be related to radiation exposure, and what might be considered part of the "norm" for this population. The "breeding structure" of the Japanese population was identified by Neel as the key variable in discerning whether spontaneous abortions, miscarriages and birth defects can be linked to radiation exposure. ("Preliminary Report of the Genetic Section" in ABCC Box 19, Genetics (#3B) 1949-1955).
James V. Neel writes in his July 1949 "Preliminary Report of the Genetic Section" that "It early became apparent that the breeding structure of the Japanese population differed significantly from that of the American and European populations, in that the incidence of consanguineous marriage was much higher in Japan. This is a matter of importance in any consideration of the rate at which induced recessive mutations might be expected to make their appearance in subsequent generations. A question of consanguinity is included in the standard questionnaire. In addition, certain specialized studies were undertaken." Neel included two tables with his report that cited the number of women registered in Hiroshima, Kure, and Nagasaki during 1948-1949 and the number and percentage of various types of consanguineous marriages. Categories included first cousin, first cousin once removed, second cousin, and other consanguinity (third cousin once removed). The total number and percentage of these consanguineal marriages ranged from 684 out of 10,547 in Hiroshima (6.49%), to 658 out of 7747 in Nagasaki (8.49%), to 431 out of 5510 in Kure (7.82%). James V. Neel reported a total consanguinity rate of 7.45% (incorporating all categories of consanguineal marriage). Neel also examined consanguineous marriage in two city and two rural village populations, finding a greater rate of first cousin marriage in rural villages. (ABCC Box 19, Genetics (#3B) 1949-1955).
In 1949 James V. Neel was hired as a Consultant in Genetics to the Committee on Atomic Casualties, National Research Council. His work involved reviewing and analyzing the data being collected by ABCC scientists in Japan, organizing a genetics research program, preparing (with A. Cuthbert) a documentary film on the activities of the genetics program, locating and participating in the training of Japanese and other personnel to work in the ABCC, completion (with M. Kodani and R. Brewer) a manuscript on consanguinity in Japan, assisting efforts to establish an autopsy program in Kagasaki, supporting efforts to develop the pregnancy registration program and a program for the study of early pregnancy termination. (ABCC Box 20, Genetics 1948 file, 15 July 1949 memo to Committee on Atomic Causalities, National Research Council from James V. Neel, Consultant in Genetics: Report on Activities in Japan during the period 8 May 1949 to 13 July 1949).
Japanese and American press coverage included reports of "freaks" being born to exposed mothers, and considerable effort was made by James V. Neel to ensure that data collection explained, in scientific terms, the potential genetic effects of the bomb. Neel saw the genetics research program he had established in Japan as a critical component in addressing public fears over radiation. In a February 20, 1951 letter to Dr. Max R. Zelle, Biology Branch of the Divisions of Biology and Medicine at the U.S. Atomic Energy Commission Neel writes: "Frankly, I believe that the bogey of the potential genetic effects of the atomic bomb is going to rise to haunt the Commission for many years to come unless they take decisive steps to ensure the collection of necessary data. By that I mean, quite simply, the continuation of the Japanese project." (ABCC Box 19, file Genetics (#3B) 1949-1955).
One of the people hired by James V. Neel to work in the ABCC genetics research program was William J. Schull, also appointed a Junior Geneticist at the institute of Human Biology at the University of Michigan. Schull's work focused more intensively on the "human breeding" problem identified by Neel, following up on Neel's initial interests and collaborating with Neel on a number of publications over the years.
James V. Neel was also responsible for identifying key personnel to work for the ABCC in Japan, and successfully arguing to the ABCC for the hiring of Japanese personnel. One of the people hired to implement research plans was Dr. M. Kodani who gathered the 1948-1949 field data on consanguinity. On June 28, 1948 Neel writes to Kodani: "If I interpret your letter correctly, you are considering studying all the children you can find who are the outcome of consanguineous matings, with the idea of comparing the incidence of various traits in them with the incidence of these same traits in the general population. It is a splendid idea. We were discussing the some such project here the other day. Everyone seems to agree that the offspring of consanguineous marriages are more apt to be defective, and yet I know of no unbiased, random figures." (ABCC Box 20, Genetics 1948 file).
James V. Neel also played an influential role in shaping the direction and interests of Japanese scientists documenting the human effects of the atomic bomb. Kodani, and a number of other scientists who carried out Neel's research plans with the ABCC, went on to form the "Subcommittee on Consanguinity Effects of the Committee on Genetics of the Japan Science Council" and to conduct a series of research studies on consanguinity in Japan, with U.S. funding identified by Neel. Neel writes in a December 20, 1957 letter to Robert S. Morison of the Rockefeller Foundation that "The Japanese Science Council has a Committee on Basic Genetics. About two months ago, following a letter of mine to the Secretary of that Committee in which I outlined in general the nature of our study, this Committee established a Subcommittee on Consanguinity Studies which is composed of the more outstanding names of human genetics in Japan." This committee proposed supporting work as outlined in Neel's research summary, and James V. Neel requested funds from the Rockefeller Foundation to "help defray the expenses of influential Japanese geneticists in coming to see our operation in Hiroshima and Nagasaki," to allow Neel and colleagues to frequently visit the Japanese operation, to acquire a complete library of Japanese works on consanguinity, to "meet unforeseen Japanese personnel needs, due to unforeseen developments in the study, and to support Japanese "field work on particular genetic problems..."
James V. Neel's 1957 proposal to the Rockefeller Foundation for discretionary funding for consanguinity studies in Japan outlined an expenditure plan that, in addition to support Japanese research efforts, would allow the establishment of a small office away from the buildings of the ABCC, and the acquisition of non-ABCC vehicles "simply to emphasize that we are really a separate operation." Neel noted the public relations problems the ABCC was having in Japan, and in presenting a public image of distance, hoped to avoid "problems in public relations." (ABCC Box 17, file Child Health Study #1, Consanguinity, 1958-1960).
According to James V. Neel, his primary motivation in initially taking on the ABCC work, was the opportunity to do genetics research. Comments in letters and reports indicate that Neel was continually frustrated with periodic threats of loss of funds for genetic research and for ABCC funding in general. For example, in a February 23, 1951 letter to William Schull, Neel notes that "for some time now the Atomic Energy Commission and the National Research Council have not seen eye to eye concerning the conduct of the program in Japan. This has finally culminated with a statement from the Division of Biology and Medicine of the Atomic Energy Commission that they were unable to furnish more that a certain set amount for the support of this particular piece of work, and a statement on February 3 by the Committee on Atomic Casualties of the National Research Council that this amount was far short of what was necessary to do the job in an acceptable fashion..." (ABCC Box 19, Genetics (#3B) 1949-1955).
Continuing funding for ABCC research was evidently problematic throughout its history. The ABCC was the target of critical attacks in the news media occasionally in the United States, more intensely in Japan. The archives included a number of press articles and translations of Japanese articles. Much of the public controversy involved the expenditure of millions of dollars to study Japanese survivors, rather than treat their medical needs. James V. Neel was an active advocate for the genetics research program of the ABCC, and the archives include a number of letters and reports where Neel urges continued funding of ABCC research programs, especially research on the effects of exposure on the first-generation. One of the sources of potential funding loss was the evidently inconclusive data produced by ABCC genetics section research. Data produced through the pregnancy registry and programs studying spontaneous abortions, when adjusted for abnormalities that might be expected given the rate of consanguineal marriage, did not produce statistically relevant documentation of genetic change, other than possible change in the sex ratio. These research programs-- the only substantive effort to document the intergenerational effects of radiation-- were terminated in 1954.
On November 27, 1955 an ad hoc committee of the National Academy of Science-National Research Council reviewed the status of ABCC major programs in genetics, consolidating efforts, and recommending continued research with (1) a fixed population; (2) epidemiological detection or continuing morbidity survey, (3) clinical detection, (4) post-mortem detection, and (5) death certificate study. Genetic studies, including consanguineal research, were not recommended. The review also noted significant problem with controls, stating, "It is primarily desirable to study a group of persons who were heavily exposed to radiation. It is plainly not possible to provide true "controls" and groups for comparative study must be accepted which would not satisfy the requirements of good design in a planned experiment. On the basis of careful review, it is believed essential that both lightly exposed and non-exposed groups should be used for comparisons. This would permit differentiation between the effects of radiation, of radiation dosage and other influences which accompanied the disaster." The study also noted significant variation in ABCC reports in the use of terms "exposed", heavily exposed," "lightly exposed," etc, and concluded that "For the present, however, it seems clear that distance and symptoms serve adequately as a first approximation of exposure and will be useful in population stratification for sampling procedures." (ABCC Box 31, File: Unified Study Program, Proposed and Approved by the Ad Hoc Conf 27 Nov 1955, "The Unified Study Program Proposed for Adoption by the Atomic Bomb Casualty Commission and Approved in Principle by an ad hoc Conference Called by the NAS-NRC November 27,1955.").
James V. Neel and the Marshall Islands
To ensure his continued access to human genetics research funds and exposed populations, James V. Neel worked to encourage interest in funding human genetics research within the Atomic Energy Commission. Neel notes later in his February 1951 letter to William Schull that:
And, in a February 20, 1951 letter from James V. Neel to Dr. Max Zelle (Biology Branch, Division of Biology and Medicine, US Atomic Energy Commission) Neel writes:
James V. Neel's proposal to use human subjects in a study on spontaneous mutation is described in the February 1951 minutes of the "Monthly Status and Progress Report for February 1951" of the Scientific Advisory Committee of the AEC (<http:/hrex.dis.anl.gov> Doc 0718956 and Doc 0720940) and the transcript of the Advisory Committee for Biology and Medicine meetings of January 12 and 13, 1951 (<http:/hrex.dis.anl.gov> Doc 0711794). An award of $19,500 annually for a three year period was granted for the "the first research contract in human genetics not dealing with the effect of irradiation, but only with natural occurring mutations in a human population." (The AEC annual record of contracts for the years 1951-1954 lists awards to the University of Michigan, with James V. Neel as principle investigator for research entitled "The development of information concerning the accumulation of deleterious recessive genes in human populations; The manner and action of selective factors in both contemporary and primitive populations; and, The rate of mutation in certain human genes"). According to the February 1951 AEC Scientific Advisory Committee minutes, Neel proposed using the Marshallese population as human subjects in a study of mutagenic change in blood proteins as a result of exposure to "natural" stressors. The study involved giving vaccines (viral agent is not identified in this document) to a previously unexposed group of Marshallese people. Neel's study was seen by the AEC as being an important first step in understanding how the immune system works, and in developing an understanding of how the human system responds to "environmental" stressors (e.g. radiation).
Note, from 1946 to 1958, the United States Government conducted sixty-seven atmospheric atomic and thermonuclear tests in the Marshall Islands. On March 1, 1954, the people of Rongelap (a community whose homelands include Rongelap, Ailinginae, and Rongerik atolls), the closest downwind community from Bikini Atoll, were exposed to radioactive fallout from the Bravo test, a 15-megaton thermonuclear weapon. Three days after detonation, the Rongelapese were evacuated from their atoll and enrolled in Project 4.1 -- a medical study documenting the long-term effects of radiation on a human population. After three years the Rongelapese were returned to their atoll to live in what was then known to U.S. scientists to be a heavily contaminated environment. Medical survey teams visited the atoll each year, and the Rongelapese were subjects in a series of studies documenting how human beings absorb radiation from a contaminated environment. Medical survey visits prioritized documentation and further experimentation, not treatment. The Rongelapese were not informed of the dangers of living in a radioactive setting until 1982, when EPA scientists attending an annual DOE/RMI meeting made suggestive comments. (See reports and summaries on the Republic of Marshall Islands nuclear Claims Tribunal website at http://www.tribunal-mh.org/ ).
James V. Neel's role in shaping the human subject research in the Marshall Islands is, at this point, unclear. Reports and communications concerning the 1951-1954 grant research are not found in the ABCC files, and other the previously mentioned references, are not found on the HREX website. This does not mean they do not exist, and indeed, these materials could still be classified, as the Clinton Administration declassification order only pertained to those experiments involving the use of radioactive substances on human subjects. The1951 research proposal discussed in committee minutes suggests the introduction of a natural occurring agent to document mutagenic response in blood proteins. Thus, blood samples before and after inoculations would have been collected. This data might have been used to establish a genetic baseline of a Marshallese population prior to the Bravo Event in 1954 (when the Rongelap population was acutely exposed, and immediately enrolled in Project 4.1 research).
James V. Neel also requested additional data collection from Rongelapese subjects in support of his genetics research in a September 25, 1957 letter to Dr. Robert Conard < http://worf.eh.doe.gov/data/ihp1b/3797_.pdf > and this request is incorporated in Conard's letter of the same date to "Chuck" at Brookhaven National Laboratory http://hrex.dis.anl.gov doc. 0726297. The Conard letter outlines the plans for the annual medical survey of Marshallese to be conducted in March 1958, including:
The 1958 medical research survey indicates that Marshallese samples were obtained < http://worf.eh.doe.gov/data/ihp1a/1024_.pdf >. Neel, Robert Ferrell, and Robert Conard eventually collaborated on a formal publication; see “The Frequency of “Rare” Protein Variants in Marshall Islanders and other Micronesian Populations” < http://worf.eh.doe.gov/data/ihp1a/1320.pdf >.
Over the years representatives from the Marshallese government submitted a series of formal complaints to U.S. staff involved in the annual medical surveys and other U.S. government representatives. James V. Neel's conclusions on the genetic effect of radiation are cited in formal responses to Marshallese. For example, in an October 1976 letter to Marshallese Congressman Ataji Balos from James L. Livermore: “I would also like to comment on your letter to Dr. Conard of July 30, 1976, concerning genetically-inherited radiation effects in children born of exposed Marshallese parents. To quote from a letter from one of the foremost human geneticists, Dr. J. V. James V. Neel, Professor of Genetics at the University of Michigan:
While James V. Neel's statements reflect findings from his Atomic Bomb Casualty Commission research on Japanese survivors of Hiroshima and Nagasaki bombings and their offspring, the 1956 National Academy of Science Committee on Genetic Effects critical review of this work noted that the Japanese study “did not prove in any sense of the word that there was no genetic effect” (see Enclosure 1: Critique of the Report of the National Academy of Sciences: The Biological Effects of Radiation” 8/23/1956:4, at < http://worf.eh.doe.gov/data/ihp1c/0507_a.pdf >) .
Advances in health physics and genetic research in the years since further call to question the validity of Neel's initial interpretations of the Japanese data with its heavy reliance on consanguinity as a discount factor in interpreting abortions, miscarriage and congenital defects experienced by the Japanese. See, for example the National Society of Genetic Counselors task force report on consanguinity, published in the April 2002 Journal of Genetic Counseling. This study noted that married cousins are still more likely than unrelated couples to have children with a birth defect, significant mental retardation or serious genetic disease, but the risk of these defects is significantly less than generally perceived (unrelated couple = 3 percent to 4 percent risk of having a child with such problems; close cousins = and additional 1.7 percent to 2.8 percent. (For a critical discussion of public perceptions and political policy relating to notions of consanguinity, see Forbidden Relatives: The American Myth of Cousin Marriage , Martin Ottenheimer, University of Illinois Press, 1996).
New research emerging from post-Chernobyl studies shows that small doses of radiation do produce genetic effects on human populations. In a study published in May 2001, children born to clean-up teams for the 1986 Chernobyl nuclear plant accident in the former Soviet Union were discovered to have an unexpectedly high genetic mutation rate when compared with siblings born before the accident. Children born to clean-up team families now living either in the Ukraine or Israel and conceived after parental exposure to radiation were screened for the appearance of new fragments using multi-site DNA fingerprinting. Siblings conceived before exposure served as internal controls. External controls (non-exposed families) were also included in the study. A sevenfold increase in the number of new bands in children born after their parents Chernobyl exposure compared with the level seen in controls was recorded. A strong tendency for the number of new bands to decrease with elapsed time between exposure and offspring conception was established for the Ukrainian families. These results indicate that low doses of radiation can induce multiple changes in human germ line DNA. ( See “Very high mutation rate in offspring of Chernobyl accident liquidators” by H. Sh. Weinberg; A. B. Korol; V. M. Kirzhner; A. Avivi; T. Fahima; Eviatar Nevo; S. Shapiro; G. Rennert; O. Piatak; E. I. Stepanova; E. Skvarskaja. In The Royal Society Proceedings: Biological Sciences (Volume: 268 Number:1471) 1001-1005).
Insights on Why James V. Neel Turned to the Amazon for Research Subjects
With reference to his work in Japan, James V. Neel initially played a leadership role in mentoring Japanese scientists, designing research agendas, identifying funds, and conducting collaborative research. As the years passed, however, Neel experienced increased difficulty in securing ABCC support for his research on consanguinity. Some of this difficulty was related to Neel's objection to pursuing formal clearance from the Japanese government to allow university research involving human subjects -- requirements that by 1962-1963 were part of the general operating procedure of the ABCC. The series of letters between Neel and ABCC, NRC, and AEC staff, and communications within these agencies about Neel's consanguinity research proposal indicate that ABCC Director Gardner wanted Neel to acquire formal clearance of his research plan from the Japanese Science Council (ABCC Box 120, James V. Neel. Dr. James V. 1960-1962 file, letter of 6 December 1963 Darling to James V. Neel) while Neel was "emphatic about wanting to steer clear of any potential red tape if possible" (ABCC Box 120, James V. Neel. Dr. James V. 1960-1962 file, 23 July 1963 letter from to Mr. Gardner from George Darling).
In an August 31, 1962 letter to James V. Neel from Richard Caldecott, Geneticist for the Division of Biology and Medicine at the Atomic Energy Commission, informed consent issues are expressed quite directly:
These letters suggest one possible reason for Neel's professional move to the Amazon. He clearly experienced difficulty in gaining continued access to Japanese subjects, and the Amazon not only allowed access to biologically discrete "primitive" populations, it represented a research climate with minimal regulatory oversight, quite unlike his experiences in trying to do research with Japanese subjects.
Other factors influencing James V. Neel's focus on Amazonian populations are found in an August 13, 1962 letter to Dr. Richard S. Caldecott, Geneticist at the AEC:
Possible explanations for why the AEC funded Neel's consanguinity work with the Yanomami, and linkages between this work and the Japanese and Marshallese research can be found in the report by “The frequency of “rare” protein variants in Marshall Islands and other Micornesians” by James V. Neel, Robert E. Ferrell, Robert A. Conard, a report that includes references to Yanomama, Japanese, and other Micronesian data in interpreting findings from genetic analysis of Marshallese blood samples ( <http/hrex.dis.anl.gov> DOE Doc. 0706747, a later version of this report was published (same title) in the Amer. Journal of Human Genetics). Other expressions of what the AEC hoped to gain from the Yanomami research are found in a January 20, 1970 letter to Dr. S.G. English from J.D. Goldstein, M.D. reporting on testimony to a scientific advisory panel to the National Academy of Science on the activities of the ABCC notes:
A February 16, 1976 Energy Research and Development Administration Press Release describing a five-year contract establishing a new University of Michigan research program in human genetics aimed at developing methods for monitoring human mutation rates under the direction of Dr. James V. Neel similarly describes the Amazonian research as an essential component of the AEC work on mutation rates:
In the field of nuclear victimization (purposeful use of peoples as subjects in human radiation experiments) 1954 is a significant date. The Bravo test exposure of a biologically discrete isolated population in the Marshall Islands created the opportunity for controlled studies of an exposed population, and stimulated parallel studies in non-exposed control populations, as well as suggesting a wide range of comparative studies involving other isolated, biologically discrete populations. Thus, in Venezuela, as in many other countries, efforts to help establish a human genetics research program in 1954 with funds, material and training from the AEC (via the Atoms for Peace program) can be broadly linked to the AEC’s interest in documenting the extent and human impact of nuclear weapons testing. And, specific experiments involving injections of radioactive iodine to indigenous subjects "in the lowlands of Venezuela and high in the Andes" beginning in 1958 are likely linked to similar studies and exposures experienced by the Marshallese, and by Alaskan Natives. Roche’s findings from his mass population study was of great interest to the U.S. Department of Defense, as he documented uniformly higher rates of thyroid radioiodine uptake at higher altitudes. ( <http/hrex.dis.anl.gov> DOE doc 0707832).
The AEC was keenly aware that a relationship existed between nuclear weapons test fallout, accumulation of strontium 90 and other isotopes in people and their food chain, and they funded numerous studies to document fallout levels and human biological consequences of exposure. (See for example, the many reports pertaining to Project Gabriel and Project Sunshine < http://worf.eh.doe.gov >. Some of these studies targeted indigenous groups who lives a subsistence-oriented lifestyle, to better understand how radiation moves through the food chain (see for example, studies involving the people of Rongelap < http://worf.eh.doe.gov >). Other studies examine natural occurring radiation and its effect on place-based people (groups indigenous to the area, with a subsistence-oriented lifestyle). These studies were located in areas where atmospheric conditions produced high levels of natural radiation (high altitude regions like the Andes), or geologic features produced high levels of radiation (for example, the American Southwest where uranium is found, the Monazite Sands region of Brazil). The radioisotope research described in Patrick Tierney's book Darkness in El Dorado is a single example of the broad array of studies done in the 1950s and 1960s.
A similar example of subjecting an indigenous population to a medical research program occurred in Alaska where human radiation experiments on Alaskan Indians and Eskimos (1955 –1957) involved the administration of one single oral dose of Iodine 131 to 102 native men, women and children. Public acknowledgement by the United States Advisory Committee on Human Radiation Experiments that a wrong was committed eventually produced a formal apology from U.S. Air Force Secretary F. Whitten Peters, who personally signed apology that letters were presented to Alaskan subjects and their families in October 2000. Apologies were accompanied by the announcement of an award settlement of $7 million dollars, including payments of $67,000 to each study participants or their descendents as compensation for perceptions of health risk associated with an oral dose of Iodine 131-- especially the anxiety and stress caused by learning of the radioactive dosage. The North Slope Borough will also receive some $1.36 million for damages relating to the community experience of hosting a medical survey team whose presence implied health care treatment rather than research objectives.
According to testimony by Chester M. Pierce, Chairman of the Committee on Evaluation of 1950s Air Force Human Health Testing in Alaska Using Radioactive Iodine 131, the medical team proceeded with no effort to obtain consent, with procedures meant to support a scientific research question rather than address healthcare needs of the people, and with and minimal (no) effort to interpret medical actions. Language and culture played a significant role in preventing meaningful informed consent. (For a summary of the medical experimentation issues in this case see the Arctic Circle Website < http://arcticcircle.uconn.edu/SEEJ/thyroid.html >; the National Academy of Science 1996 publication The Arctic Aeromedical Laboratory's Thyroid Function Study: A Radiological Risk and Ethical Analysis ; the Clinton Administration ACHRE summary of the case (Advisory Committee on Human Radiation Experiments1995:598-603), and newspaper accounts of the settlement ("Feds, Natives settle over '50s iodine experiments" by Sam Bishop, Fairbanks Daily News-Miner, 26 October 2000). The award itself was paid through United States congressional action. (For congressional text noting the damage and allocating compensatory funds see < http://www.defenselink.mil/dodgc/lrs/docs/PublicLaw106259.txt >).
Congressional action approving the Air Force settlement award was in part tied to the 1995 ACHRE recommendations which state: "Recommendation 2. The Advisory Committee recommends to the Human Radiation Interagency Working Group that for subjects of human radiation experiments that did not involve a prospect of direct medical benefit to the subjects, or in which interventions considered to be controversial at the time were presented as conventional or standard practice, and physical injury attributable to the experiment resulted, the government should deliver a personal, individualized apology and provide financial compensation to cover relevant medical expenses and associated harms (pain, suffering, loss of income, disability) to the subjects or their surviving immediate family members." (Advisory Committee on Human Radiation Experiments Final Report, U.S. Government Printing Office, 1995:803).
This review of ABCC reports, James V. Neel publications, and related correspondence illustrates common threads between the Japanese, Marshallese and Yanomami research. Significant concerns include James V. Neel's efforts to assess the reproductive consequences of consanguineal relationships; to identify and assess natural mutagenic processes; to identify population-specific variants in blood proteins; and to apply this information in efforts to define and interpret the human effects of radiation.
This review also raises considerable questions concerning James V. Neel's findings that atomic bombs produced no significant genetic effects on the exposed and the subsequent generation. James V. Neel's work in Japan, especially his genetic research, involved questions of reproductive effect from atomic exposure. James V. Neel asserted that the incidence of reproductive abnormalities occurring in the Japanese population was a factor of consanguineal marriage, rather than acute exposures associated with the atomic bomb. James V. Neel's use of a consanguinity factor to discount documented abnormalities did not include any evidence of pre-bomb data on consanguineal marriage rates in the Japanese population, no pre-WW II data on birth defect rates in the Japanese population, no discussion of how World War II and its aftermath might have influenced the rate of consanguineal marriage in Japan, and no discussion of other factors that influence reproductive abnormalities (including the biochemical weapons production, testing, and exposures during WWII).
James V. Neel's work was the first such work funded by the AEC, and the first published work on radiation effects in the field of human genetics. James V. Neel's assertion of the role of consanguinity in explaining the incidence of miscarriage and birth defects in exposed populations was received as scientific evidence, and used to interpret and explain birth defects in the Marshallese population exposed to fallout from atmospheric tests. Documents in the HREX files reporting National Academy of Science Advisory Board discussions of James V. Neel's work, and documents in the Department of Energy archive responding to concern consistently quote James V. Neel's findings that there is no scientific evidence for genetic abnormalities in the first or second generation as a result of radiation exposure, outside of the norm for that population. "Norm" has been discounted to reflect predicted rates of defect in a population with a pattern of consanguinity.
Appendix: Background Information
1. BACKGROUND on the Atomic Bomb Casualty Commission (ABCC).
James V. Neel served as the acting Director for the field studies program in Japan, setting up and directing the research program on Nagasaki and Hiroshima Survivors. The following overview is excerpted from U.S government descriptions of the ATOMIC BOMB CASUALTY COMMISSION, 1945-1982 (pasted from: http://www4.nas.edu/arc.nsf/web/ABCC_1945-1982 ).
In November 1946, President Harry S. Truman issued a directive authorizing the NAS- NRC to undertake the long-term study of the survivors of the atomic bombings of Hiroshima and Nagasaki. Just prior to Truman's directive, a five-man commission, operating under the auspices of the National Research Council's Division of Medical Sciences and calling itself the Atomic Bomb Casualty Commission, had been sent to Japan to conduct a preliminary survey of the situation.
The Atomic Bomb Casualty Commission (ABCC) was officially established under the direction of the Research Council's Division of Medical Sciences in March 1947. The ABCC, which was responsible for carrying out research in the field, was overseen by the division's Committee on Atomic Casualties, which later became the Advisory Committee on ABCC. Operations were funded by the newly created Atomic Energy Commission's Biology and Medical Division.
The survey findings of the original five-man NAS-NRC commission, communicated in December 1946, made up the ABCC's first report. The first research program proper set up by the ABCC was a hematological study, begun under James V. Neel in March 1947. By 1950, the ABCC had a number of departments in operation, and had established a series of studies that would include research on radiation cataracts, leukemia and other cancers, survivors' aging and mortality rates, sex ratios of survivors' offspring, and genetics.
Logistical and organizational problems of the early ABCC were such that by 1955 it appeared that the program would have to be terminated. Toward the end of 1955, a committee under the direction of NAS Member Thomas Francis was sent to Japan to assess the ABCC and its’ programs; on the committee's recommendation a new and more effective study program was implemented. By 1957 Darling was made director, and it was under his long leadership -- ending only in 1972 -- that the ABCC was able to reorient and stabilize its operations. An Adult Health Study involving biennial examinations of survivors was soon established, followed not longer after by new cytogenetic studies. It was also under Darling's leadership that the ABCC instituted bilingual technical protocols and increased the participation of the Japanese National Institute of Health in ABCC studies.
By the early 1970s, constraints imposed by increased operating costs began to make themselves felt. In response to requests that the Japanese Government increase its support of the ABCC, a new, binational private foundation, the Radiation Effects Research Foundation (RERF), was negotiated into existence, and in 1975 it replaced the ABCC while continuing the latter's programs.
(Note-- the Radiation Effects Research Foundation was housed at the University of Michigan in the Department of Human Genetics, under the direction of James V. Neel, with funding from the Energy Research and Development Administration. The program goals included developing methods for monitoring human mutation rates, and related contributions to the understanding of the biological effects of "energy-related" pollutants).
2. BACKGROUND on the "Atoms for Peace" Program
Marcel Roche, who Patrick Tierney notes as giving injections of radioactive iodine to the Yanomami, was a licensed member of this program. The brief summary of the Atoms For Peace Program is excerpted from the "International School focused on peaceful uses of nuclear energy" webpage text on the Argonne National Laboratories site. <http://www.anl.gov:80/OPA/news96arch/news961012.html>
“In December of 1953, President Dwight D. Eisenhower, in an effort to promote international scientific cooperation, proposed an "Atoms for Peace" program to the United Nations General Assembly. He offered other nations help from the United States in harnessing the power of nuclear energy for peaceful uses. Nearly two years later, on Oct. 12, 1955, that vision began to bear fruit with the first graduating class of the International School of Nuclear Science and Engineering at Argonne National Laboratory. The school's first session began on March 14, 1955. In attendance were 40 students from 20 countries, all from industry. The curriculum included unclassified courses in design, construction, and operation of reactors for nuclear research; principles of design of nuclear power reactors; chemistry and metallurgy of reactor materials; handling of irradiated materials; and other related peacetime applications of nuclear energy... By 1959, Argonne had trained 420 students from 41 countries, including the United States. When the school closed in 1965, 800 students from throughout the Free World had participated in the training program.”
3. BACKGROUND on the Atomic Energy Commission and later programs involved in human subject experiments
The following is an excerpt from "HUMAN RADIATION EXPERIMENTS: The Department of Energy Road map to the Story and the Records" on the Department of Energy webpage http://tis.eh.doe.gov/ohre/roadmap/roadmap/index.html (article date 02/09/1995); section title: Predecessor Agencies and Human Radiation Experiments: A Headquarters.
DOE inherited a legacy of human radiation experiments from predecessor agencies, including the Manhattan Engineer District (MED) and the Atomic Energy Commission (AEC). The Manhattan Project engaged in human radiation experimentation as part of its mission to build the atomic bomb. This mission included studying the health effects and hazards posed by nuclear energy. The AEC, postwar successor to the MED, had jurisdiction over both peaceful and military nuclear development and investigated related biomedical issues.
Shortly after the war's end, cancer research assumed a prominent place on the national agenda. At the direction of Congress, the AEC funded considerable research into cancer diagnosis and therapy. After the AEC was abolished in 1975, the Energy Research and Development Administration (ERDA) briefly had responsibility for all AEC functions except those related to nuclear regulation, which devolved upon the Nuclear Regulatory Commission (NRC). DOE came into existence in 1977 and in turn assumed responsibility for nuclear biomedical research and weapons production.
The Manhattan Project engaged in human radiation experimentation as part of its mission to build the atomic bomb. Attempts to understand radiation and its impact on the human body began shortly after the discovery of x rays in 1895. The Federal government, however, did not sponsor human radiation experimentation until the Manhattan Project was on the verge of building the atomic bomb. This project required development of a new industry that created hazardous radioactive materials, some of which did not exist until the war effort. MED biomedical researchers began research and experimentation with animals to establish exposure standards for the workers. Yet animal experimentation proved incapable of providing all needed data. The Manhattan Project leadership therefore authorized studies with radioactive materials in human subjects...
... Creating the atomic bomb involved many unique and little-understood health hazards. The most novel was radiation. Scientists knew that radiation was hazardous; for example, the health effects suffered by radium dial painters earlier in the century had been well documented. What was not known was how much radiation would harm workers. But the plutonium work, which produced highly radioactive and toxic materials, presented the greatest hazards. Other hazards included chemical agents, high-voltage electricity, and the potential for explosions in experimental work that involved the use of gas and liquids under great pressure. To protect workers from these hazards, the Manhattan Project organized a Medical Section...
...Most project medical research involved experimentation with animals through programs established at the University of Rochester and elsewhere. Manhattan Project researchers, however, also used humans as research subjects; the most widely known example of this is the plutonium injection experiments.
As early as January 1944, Glenn Seaborg warned that "the physiological hazards" of plutonium might "be very great" and suggested that" a program to trace the course of plutonium in the body should begin as soon as possible." Animal studies had shown plutonium to be toxic and that different species excreted it from the body at different rates. Project physicians therefore wanted human data to obtain reliable information for the establishment of exposure levels for workers. In presenting these considerations to Los Alamos laboratory director J. Robert Oppenheimer on March 26, 1945, Louis Hempelmann asked that the MED "help make arrangements for a human tracer experiment." Such arrangements were made, and a series of human experiments began in 1945.
Other human radiation experimentation was conducted under the Manhattan Project. In the mid-1940s, University of Rochester researchers gave five patients radioactive polonium to obtain excretion data. Rochester researchers also injected six patients with uranium salts to investigate the metabolism of uranium by the body and to observe its effect on kidney function. To detect radiation skin effects, MED contractor researchers in Tennessee also exposed 10 subjects to beta radiation.
The Manhattan Project also assisted postwar radiation experiments by non-Government physicians and researchers. In 1946, Oak Ridge began shipping radioisotopes to private physicians and other researchers. This distribution made radioisotopes available in far greater quantities and at much lower cost than previously. The isotope distribution program was the earliest, and for many years the most successful, aspect of the postwar promotion of "the peaceful atom." Researchers used isotopes to study the body's metabolic processes and to conduct experimental treatments for diseases, principally cancer. Some of this work involved experimentation with human subjects. The same distribution program provided isotopes to agency and contractor researchers.
... After the war, President Truman submitted legislation to Congress to set up a permanent atomic energy program under military control. After vigorous debate, however, Congress decided to charge a civilian agency with atomic energy and weapons development. The Atomic Energy Act of 1946 created the Atomic Energy Commission (AEC) to oversee both peaceful and military development of the atom. The law also created the Joint Committee on Atomic Energy to provide congressional oversight. Reflecting increasing tensions with the Soviet Union, the Atomic Energy Act ordered the AEC to develop atomic energy "subject at all times to the paramount objective of ensuring the common defense and security."...
... In January 1947, the AEC inherited the programs of the Manhattan Project. Coming to the agency were 254 officers; 1,688 enlisted men; 3,950 Government workers; 37,800 contractor employees; and plants and laboratories worth over $1 billion. The major facilities included the Los Alamos laboratory, the Oak Ridge enriched-uranium production plants, and the Hanford plutonium production complex. The AEC also assumed responsibility for uranium mining and refining activities. In addition, nonmilitary atomic research laboratories were under development at Argonne, near Chicago; Brookhaven on Long Island; and Oak Ridge.
... The Atomic Energy Act of 1946 gave the agency responsibility for atomic energy activities from weapons production to scientific and medical research. The act also placed security restrictions on most information pertinent to atomic-energy development. Legally mandated classification restrictions applied to biomedical information associated with uranium or plutonium production, weapons production, or weapons design. Some information, such as medical research and treatment with radioisotopes, was openly available...
.... In some areas, such as weapons research and development, the AEC commissioners maintained central management control. In other areas, such as biomedical research, the AEC exercised less management oversight.
... During the war, the Manhattan Project medical program gained only preliminary information about the hazards of radioactive substances. There was a desire to find out much more about how uranium, plutonium, and other fission products acted in the human body: What amounts of radioactive dusts and gases were harmful to man? Exactly how toxic were uranium, plutonium, and their compounds? What was the most hazardous means by which radioactive substances were introduced into the body by ingestion, by inhalation, or by skin absorption? Physicians had no means available to stop or delay radiation injuries, nor did they possess therapeutic measures to treat injury from radioactive substances. To address these issues, an organizational unit to do the work was required.
... An Advisory Committee on Biology and Medicine was established in 1947, and a Division of Biology and Medicine in 1948. The AEC charged the new division with overseeing biomedical research programs, including human experimentation. Until the closed communities of Los Alamos, Oak Ridge, and Hanford were opened, the division also supervised clinical medicine programs for the treatment of resident workers and their families. By fiscal year 1949, the division was managing an operating budget of $14.6 million. Although the AEC biomedical division was charged with protecting the public from the hazards of atomic energy, its initial focus continued to be upon atomic workers. Thus, one area of human subject research in which the AEC built upon precedents was investigation of the biomedical hazards of uranium, plutonium, and fission products. Biomedical research projects devoted to investigating these hazards were authorized at the Argonne, Brookhaven, and Los Alamos Laboratories, and at the University of Rochester, the University of California (Berkeley and Los Angeles), Columbia University, and Case Western Reserve University. Most of these research projects involved experimentation with animals.
Another area in which the AEC built upon Manhattan Project foundations was isotope distribution, headquartered in Oak Ridge. The AEC stimulated private research with radioisotopes by providing funding to private physicians and researchers. The isotope distribution program was the AEC's first significant peaceful application of nuclear science, and the agency vigorously promoted it. By the end of 1954, Oak Ridge had made 64,202 shipments of radioisotopes, most to non-Government institutions. Some of this research involved human subjects.
... In 1948, Congress gave the AEC $5 million for the express purpose of developing a cancer research program. With the funds, the AEC built cancer research hospitals at the University of Chicago, Brookhaven Laboratory, and the Oak Ridge Institute of Nuclear Studies. Cancer therapy was not the only new area of AEC sponsored or supported human radiation studies in the late 1940s and 1950s. Calibration of improved radiation measuring equipment involved volunteers ingesting small amounts of radioactive material. The AEC also sponsored human x-ray tests and studies of skin absorption of radioactive substances, and also began studying radium dial painters and other groups who ingested radium before World War II.
The AEC and Human Subject Consent, 1940s 1950s
To establish guidance for private research using radioisotopes on people, the AEC looked to its Subcommittee on Human Applications. The subcommittee, part of the larger Committee on Isotope Distribution, drew up a list of radioisotopes deemed safe for use in humans. The subcommittee also compiled lists of medical schools, hospitals, clinics, and other institutions qualified to conduct human radioisotope research. After the subcommittee reviewed an institution's qualifications and granted approval for use of an isotope in human research, the subcommittee expected each institution to form a local use committee to monitor individual research projects. This procedure limited AEC oversight of the clinical procedures and ethical practices of individual private physicians who used radioisotopes for human subject research. There was no requirement imposed by the AEC that private researchers obtain consent from subjects.
Ethical issues were, however, considered in the context of research performed directly by AEC employees or in AEC-owned, contractor-operated facilities. In an April 1947 letter to Stafford Warren, chairman of the Interim Medical Advisory Committee, AEC General Manager Carroll Wilson stated that radiation should not be administered to medical patients unless there was "expectation that it may have therapeutic effect." Any human experimentation would have to be susceptible of proof from official records that the patient was "in an understanding state of mind, was clearly informed of the nature of the treatment and its possible effects, and expressed his willingness to receive the treatment."
While written consent from the patient was not required, doctors were instructed to attest that the subject had willingly consented. Wilson's directive applied to AEC officials and to employees of its contractor- operated facilities.
The record does not show that the AEC distributed or enforced Wilson's policy. Indeed, the directive was quickly superseded. During March 1951, Shields Warren, the first director of the AEC Division of Biology and Medicine, listed "guiding principles" for human experimentation for a Los Alamos Laboratory official. Warren drew upon another Wilson letter, a report from the AEC's Medical Board of Review, minutes of the September 1948 meeting of the Advisory Committee on Biology and Medicine, and his own experiences. Warren did not mention or refer to Wilson's April 1947 directive. Warren's principles for human subject research included five requirements:
1. There must be hope of therapeutic benefit;
2. There must be a provision requiring written informed consent;
3. The subject would have the right to revoke consent at any time during an experiment;
4. The research must require only limited use of classification or secrecy; and
5. Any experimental work involving humans, including self-experimentation, would have to be supervised by a physician.
Charles Dunham, who replaced Warren as Division of Biology and Medicine head, modified this policy. Thomas Shipman, the Los Alamos Health Division leader, wrote Dunham in 1956, noting widespread ignorance of Warren's human experimentation policy. Shipman, who was proposing research on normal volunteers, confessed that he had heard about the policy but had never seen it in writing. In his response to Shipman's request for guidance, Dunham did not require that experiments carry some prospect of therapeutic benefit for the subject, but did mandate that all subjects provide informed consent. Dunham also added two provisions:
1. Radioactive substances must be used in amounts judged small enough to avoid harming subjects; and
2. Approval for human experimentation must be obtained by a senior medical officer.
Like Warren before him, Dunham did not refer to Wilson's April 1947 directive.
These letters suggest that the AEC lacked a firmly established policy regarding human radiation experiments during the 1940s and 1950s and used different policies at different times. On their face, these policies appear to be strict regarding both expected therapeutic benefit and written consent. What is not clear, except by negative inference, is whether any effort was made to widely distribute and enforce the policies. No documents have been found indicating that the AEC did either. There was no requirement imposed by the AEC that private researchers obtain consent from subjects.
... The Korean war ended in July 1953, but the AEC's intensive programs to refine nuclear weapons continued. Atmospheric nuclear tests were conducted in Nevada during 1951, 1952, 1953, 1955, 1957, and 1958; and at the Pacific proving grounds during 1951, 1952, 1954, 1956, and 1958. The most important tests were the Castle series of 1954, which took place in the Pacific. Soon after the series, the AEC possessed a hydrogen weapon and a new plan to produce mass quantities of a few weapons types. Bravo, the first Castle shot, also ultimately affected agency biomedical programs.
Los Alamos scientists fired the Bravo shot during March 1954. The blast size and amount of radioactive fallout were far greater than planned for: Bravo fallout contaminated 7,000 square miles, some of it with very high radiation. Fallout descended upon the military and scientific task force conducting the test series, Marshallese islanders, and the crew of a Japanese fishing vessel, the Lucky Dragon.
These fallout incidents, combined with the large number of atmospheric weapons tests conducted by both the United States and the Soviet Union, sparked public debate in the United States over a proposed test ban. A closely related debate also followed over the health hazards posed to the public by atmospheric nuclear testing. AEC assertions that fallout posed little threat to Americans were challenged, and public controversy raged until President Kennedy signed a limited test-ban agreement with the Soviet Union in August 1963. The treaty prohibited testing in the atmosphere, underwater, and in outer space.
The fallout debate had caught the AEC unprepared and the Division of Biology and Medicine in a difficult position. Biomedical research into the hazards of fallout would take years to bear fruit, yet there was an urgent demand for information. To provide answers, the division gathered data from all relevant ongoing research projects, including one called Project Sunshine. This project had begun as an evaluation of the hazards associated with nuclear war and grew into a worldwide investigation of radioactive fallout levels in the environment and in human beings. Work in this area included collecting human tissues and samples of plants and animals from around the world.
The fallout controversy compelled the AEC to focus more attention on questions related to public protection. It also gave greater public visibility to AEC biomedical research. The Joint Committee on Atomic Energy pushed the agency to place greater resources into investigating the health effects of fallout. As a result, in 1958, the AEC nearly doubled its prior level of spending on biomedical programs over a 5-year period. The director of the Division of Biology and Medicine, Charles Dunham, stated that this effort would require "studies on human subjects," because data from animal experiments could not be applied directly to human experience. Dunham stated that human experiments were safe because of technical advances that allowed the use of radioactivity in very small amounts. These experiments required special equipment found in hospitals or large medical centers. Dunham urged the agency to expand its contractual support for human experiments at such institutions and increase funding for work in AEC-owned clinical facilities... During the 1950s, AEC contractor researchers participated in work in which subjects were injected with small amounts of radioactive strontium, calcium, or other substances to help determine the efficiency of chelating agents in removing radiation from the body. The fallout controversy imparted greater urgency to other AEC-sponsored research efforts to learn about human retention and excretion of radioactive materials. In the 1960s, the agency conducted tests in which human subjects were exposed to environmental releases of radioiodine to provide data on its absorption by the human body.
... The AEC reached a crossroads in 1963. Up to that time, the problems of the military atom had commanded the most time, attention, and energy from agency leaders. Over the next 10 years, the problems of the peaceful atom drew increasing negative attention to the AEC. Always anxious to promote the peaceful atom, the AEC was unable to do so effectively until after Congress amended the Atomic Energy Act in 1954. The 1954 Act encouraged private participation in atomic energy development, giving the AEC authority to remove entire topical areas of nuclear science and technology from secrecy restrictions. This law permitted the agency to foster a commercial nuclear power industry and to participate in international peaceful atomic energy activities. Both meshed with President Eisenhower's desire to reap practical benefits from America's lead in nuclear technology. Eisenhower proposed atomic energy development under United Nations auspices in his heralded "Atoms for Peace" speech. As a result, the AEC actively participated in the creation of the International Atomic Energy Agency, helped build research reactors abroad and, over a 10-year period, helped to organize three international peaceful atomic energy conferences in Geneva, Switzerland.
... As the AEC devoted more time to the peaceful atom, its biomedical research program continued along lines set earlier. This included substantial research into fallout and the occupational hazards of atomic energy. During the 1960s, the Division of Biology and Medicine gradually devoted greater resources to the hazards of the peaceful atom. Some of this research involved human radiation experiments.
In the 1960s and 1970s, researchers in AEC-owned and private facilities expanded into new areas. The AEC funded experimentation in which prisoners in Oregon and Washington were administered radiation from x rays to obtain data on radiation effects upon testicular cells. Contractor researchers used particle accelerator beams and total body neutron activation analysis in other human radiation experiments.
The direct applications of nuclear science and technology to medicine grew rapidly after World War II. By the early 1960s, the Government had made one-half million shipments of radioisotopes to physicians and other users. Nuclear medicine had become an accepted field of specialty and most human radiation experimentation was, in fact, being conducted by private physicians and private hospitals. The agency placed radioisotope licensing activities under its regulatory staff. All other radioisotope programs were the responsibility of officials charged with overseeing promotional activities.
The Atomic Energy Commission funded experimentation in which prisoners in Oregon and Washington were administered radiation from x rays to obtain data on radiation effects upon testicular cells.
By the 1960s, the Division of Biology and Medicine had systematized a decision-making process for biomedical research projects and proposals, including those which involved human subject research. The Division of Biology and Medicine approved most biomedical research through an annual budget cycle. Proposals for new research originated with doctors and scientists in AEC contractor laboratories or in AEC-funded university research projects. The proposals were drafted on a Proposal and Authorization for Research or Development form, also known as Form 189, which contained project descriptions, justifications, and cost estimates. After laboratory directors and university project leaders approved them, completed Form 189s were forwarded to the Division of Biology and Medicine, where they were reviewed by the branch chief who oversaw research in that discipline. Costs were then rolled into a consolidated division budget request. At that level, individual projects were no longer identified.
By 1970, the Atomic Energy Commission encouraged its sites to form institutional review boards to review human subject research projects.
When the division director and his senior managers approved the consolidated budget and the research that it would fund, the budget went to the AEC general manager and commissioners for approval. Approval at this stage was given for spending levels, not for individual research projects, or even for groups of them. By approving the Division of Biology and Medicine budget, and incorporating it into the agency budget submitted to Congress, the AEC general manager and commissioners authorized the biomedical research that it would fund.
The agency used the Advisory Committee on Biology and Medicine to provide advice on general biomedical research and health policies and programs. Except for a short period in the early years of the agency, the committee did not review individual research projects. Although the committee in theory presented its recommendations to the AEC commissioners, in practice the committee functioned as an advisor to the division director.
Occasionally, the agency did consider biomedical research programs or projects outside the budget review process. This was generally limited to programs or projects considered controversial or unusually expensive. For these projects, the division director would incorporate project proposals and recommendations into an agency decision paper and seek approval of the paper through the agency's formal policy decision process.
... The U.S. National Institutes of Health (NIH) adopted formal guidelines for the protection of human subjects in 1966. The Division of Biology and Medicine informed AEC facilities of this and some sites chose to apply elements of the guidelines, although there was not yet a requirement to do so. By 1970, the AEC encouraged its sites to form institutional review boards to review human subject research projects. The NIH guidelines required informed consent from subjects before experimentation and required that subjects be told that they could withdraw consent to experimentation at any time. Many local institutional review boards formed at AEC laboratories did require written consent from subjects.
... The AEC faced credibility problems as the country faced an energy crisis. Energy problems had started with the northeast power blackout of 1965, which had interrupted electric power for nearly 30 million people. Over the next 2 years, 20 other major power failures occurred across the nation. By decade's end, many sensed that an energy crisis was approaching and expected greater Federal action to solve the problem. The oil embargo of 1973 1974 deepened the sense of crisis... One result of the energy crisis was a movement to unify scattered Federal energy programs under a single organization. In 1973, President Nixon unsuccessfully proposed a Department of Energy and Natural Resources. Then, in late 1974, Congress passed the Energy Reorganization Act of 1974, which abolished the AEC and established the Energy Research and Development Administration (ERDA), a single energy research agency, and another agency, the Nuclear Regulatory Commission, which was given the AEC's regulatory functions. ERDA also inherited the nuclear development and weapons-related programs of the AEC.
... In 1974, the Government adopted uniform regulations for all Federal agencies involved in human experimentation, including ERDA. These regulations required independent institutional review boards to approve all experiments before they took place. All subjects also had to provide written evidence of informed consent.
... The most controversial biomedical problem ERDA inherited involved the wartime plutonium injection experiments. By now, documents related to the experiments had been declassified, although knowledge about them was largely confined to biomedical circles. In 1967, Patricia Durbin, a radiobiologist at the Lawrence Radiation Laboratory, learned that several patients injected in 1945 were still alive. She urged that the AEC examine them to obtain additional data about the retention and excretion of plutonium.
The University of Rochester, which still operated under an AEC biomedical research contract, was authorized in 1973 to conduct medical examinations of three of the four surviving subjects. While official agency policy mandated full disclosure, the three were not told that they had been injected with plutonium nor was the reason for their reexamination revealed. After learning of this, the AEC commissioners ordered an investigation and directed that full disclosure be made to the subjects. The AEC did not, however, reveal the experiments to the public. ERDA officials later published detailed information about the experiments in 1976.
... President Carter sent a proposal to Congress in 1977 to unify Federal energy policy planning and research and development units in one Cabinet-level department. Congress acted on the proposal promptly, and the Department of Energy (DOE) came into existence in October 1977.
The Department of Energy absorbed the Federal Power Commission, the Federal Energy Administration, and other smaller energy programs as well as all ERDA facilities, laboratories, production plants, and its division of biomedical and environmental research. The Department also became responsible for nuclear and other energy technology development, for nuclear weapons development, and for energy-related biomedical and environmental research, including human radiation experimentation activities. DOE inherited ERDA's radiation research activities and the regulations that the agency had promulgated to protect human subjects. Biomedical research activities were assigned to the office of energy research. By this time, predecessor agencies had established a legacy of research in biomedical research, including human radiation experiments.
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