Response to Query, AEC Human Testicular Irradiation Project (Plutonium Injection Experiment)

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Response to Query Beginning in 1963, AEC funded a series of radiation experiments using as subjects inmates at the Oregon State Prison. The inmates were irradiated at varying levels to determine the effects of such exposures on human fertility. The actual irradiations were completed 'in 1971. AEC continued bo provide support f o r data analysis, and ERDA is currently providing funds to maintain custody of*various medical specimens which were collecte preparation of scientific reports. fWillamefte Week, a small Oregon weekly newspaper, ?rinted a story dealing with the experiments on February 17, 1976. The experiments involved 67 prisoners at t h e Oregon State Prison at Salem. Dr. Carl C . Heller of the Pacific Northwest Research Foundation, Seattle, was the senior investigator. In December 1972, Dr. Heller suffered an incapacitating stroke; on February 22, 1973, Mavis J. Rowley, his senior research assistant, was named principal investigator and placed in charge of the numerical data and physical specimens which were collected. The total furiding for the project, by A E C and ERDA, has amounted to through July 31, 1973, and $22,165 additional for August 1, 1973, to July 31, 1974 -- the terminal year for the contact listing both Dr. He€ler and Ms. Rowley a s investigators. From October 1, 1974, through December 31, AEC provided $1.064 million from June 1963, 1975, Mavis Rowley, now affiliated with the Swedish Hospital in Seattle,

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has received $ 3 4 , 5 5 0 in operating funds, under a spearate contra iei c to assist in publishing parts of the accumulated data, and see the storage and preservation of blQod and semen samples, and 'of material from testicular biopsies. No additional fxnding has been approved In the Oregon study, the prisoner volunteers were given x-ray exposures Pto the testes in doses ranging from 8 to 600 rads, in order to obtain data Sixty-one prisoners receivedon specific male sterility caused by radiation. a single exposure, five received two exposures, and one received three To volunteer and be considered, prisoners were required to be under of his part of the project; consent of the prisoner's wife was obtained lor this procedure. Ages of the irradiated prisoners ranged from 2 5 to 5 2 . Each inmate agreed to have a vasectomy at the completion All prisoners involved eventually received a vasectomy. The consent procedure involved full explanation of the short- and long-term effects, usuelly in the presence of a chaplain. were required to have a preliminary psychoiogical examination and to sign notices of infomed,consent. It was made clear to each subject that he could withdraw from thc experiment at any time. The jusrification gii.venfor the project at the time was t h s t data - drawn from experiments vith animals could n s t be extrapolated to ma?-. The study w a s approved only after all appropriate human use committees

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and criteria which were. then in effect had been satisfied. ( A H k a n Use ! Committee was established in 1966, in response to the Surgeon Ge eral's memorandum of February 8 , 1966,) The procedures and standerds employed were again reviewed at later stages in the research. At the time the project began, the question of radiation-induced sterility was considered critical, and it was felt that the objectives 'of this research were valid. All guidelines governing the use of humans in experiments, which had been set forth at that time by the Department Questions will probab1.y be raised concerning ERDA's position on this specific experiment, and on the general issue of using humans a s subjects in medical-scientific experiments. The Oregon prison study was initiated at a time when the use of prisoners in experiments was much more common 'khan at present. The record suggests that for many of the volunteers a prime incentive to participate in the experiments was the feeling that they were performing an important public service. As t o ERDA's current attitude toward such experiments: It is, and vi11 continue to be, ERDA's policy to try to learn as much a s possible fron the experience of humans who have been subjected to radiation through accidental or occupational exposure. However, it is difficult to imagine circumstances under which ER'3A's need for information would be so compelling as to warrant experiments involving the irradiation of l-.:umac,s for the sola or primary purpose of studying effects.

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If an occasion were to arise in which information on radiat on I i ;Ieffects was desperately needed t o protect national health and s a ety, and there were no other way to obtain such information, it is conceivable that ERDA might consider using human subjects. ERDA would be controlled entirely by HEW or other prevailing national In that event, I It should be emphasized that the possibility for future qERDA irvolvement in such studies is extremely remote. (Although the Willa.mette newspaper is not expected to discuss it, the AEC supported a similar project beginning at the same time in Washington State Prison at Walla Walla. The contract, with Dr. C. Alvin Paulsen, School of Medicine, University of Washington, was terminated in 1970-71, after seven years and a cost of about $5G5,000. prisoners were involved in Washington state, and the same basic criteria Public Affairs Officer Office of Public Affairs