Response to Request for Further Clarification of Radiation Experiments Performed on Human Subjects

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Response to the Honorable Richard L. 0t tinge rl.s Request for Further Clarification of Radiation Experiments Performed on Human Subjects 1. a ) The transmittal memorandum from Assistant Secretary Tri vel piece to the Secretary states that : "Many of the original records are currently.. unavailable because they have been lost or destroyed." Please provide the Department ' s policy regarding the destruction of the medical records,legal records and other documents relating to radiological residents of islands which received fallout from atmospheric bomb tests in the names and addresses of the individuals to enable long - term evaluation. Please also identify efforts made to maintain these documents, The Department ' s policy regarding destruction of records is contained in DOE Order 1324.2, RECORDS DISPOSITION. This Order imp1 ernents requi rements of the Federal Property Management Regul at ions on the Disposition of Records and record control schedules (FPMR Subpart 101-11.4) as promulgated by the General Services Administration.In short,the directive contains various schedules that identify particular types of records and retention periods which are approved by GSA (National Archives and Records Service). Copies of the Order and the Regulations are attached.

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treatment it was " general practice to in form participants...with respect to the purpose of. ..and the potential hazards involved. " Please provide all documentation supporting this statement. The memorandum also states that for both volunteer studies and medical In the early days o f AEC, no formal written consent procedures were used. I n 1966, the Advisory Committee for Biology and Medicine recommended tothe Chairman, AEC, that the Division of Biology and Medicine (DBM) formalize consent procedures for human research activities supported by them. Subse que ntl y,this was done by DBM by officially adopting the NIH procedures for protection of the individual as a research subject. The Director, DBM, supported by DBM to place on file with AEC by July 1, 1970, acceptable ' assurance as described in the NIH procedures. An example of the Director ' s instructions and an institution ' s response is provided. On November 30, 1976, final regulations for protection of human subjects was . published in the Federal Register, Vol. 41, No. 231. More recently, DOE has participated in both the Inter agency Ad Hoc Committee for the Protection of Human Subjects and the subsequent Inter agency Human Subjects Coordinating Committee. 15 other Federal agencies concurred i n thp Model Policy for the Protection of ment ation will be conducted under the aegis ofthe White House Science. As a result,in October 1984, DOE along with The publication of the policy and subsequent agency imple-

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sheets provided t o the Subcommittee. Please provi de a1 1 supporting documentati on supporting the summary fact The individual f a c t sheets which were used t o prepare the summary f.act sheets are pro vi ded. (Vol umes 1-8)

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3. Regarding fact sheet numbered SFSl.002: a.) What were the results of these tests ? b.) What tracking a n d documentation was maintained on these subjects a f t e r the 2 1 day and 4 month period? c.) Please identify the health status, names and addresses of each participant of these studies who is, or i s thought t o be, still reports 952-1 and 952-3 which are attached t o Fact Sheet No. 118 radium b u t only 0.02 percent absorption of thorium. absorbed localizes in the skeleton. Very briefly, the data show about 20 percent absorption of The radium that 4s b.) Because o f the short half-lives (3.66 days for Ra-224 and 24.1 days for Th-234), the small doses administered and the very low absorption of thorium, no l a t e eff.ects were expected, and there was no long-term c.) A report on the current status of persons involved in the Ra-224 and Th-234 ingestion studies carried out a t MIT inthe mid-1960's was attempted through telephone conversations with Drs. Robley Evans and MIT and were the principal investigators on this project. the study was t o mimic radionuclides known to be present in the paint used i n the radium dial industry t o which a large population of workers These scientists held professorial positions a t Dr. Maletskos worked with MIT legal staff f o r about one year i n designing a written agreement o f consent for the volunteers to sign. He also spent considerable time explaining the details of the study and the reasons behind itto the persons a t the New England Center for Aging. "Because of the short physical half - life of the radium isotope and the very low gastrointestinal absorption of the thorium, there was no reason t o follow the patients beyond the point at which measurements were possible." Detailed records of t h i s study may be found i n the MIT Archives, b u t history on .the patients beyond the period of measurement would have remained property of the Center for Aging. ' This institution i s no longer in existence and Dr. Maletskos had "no idea how any records of sur vi y al history could be obtained." He stated that finding one of the patients,if still a1ive;rnay be " like doing a missing

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living might be possible, b u t would be very time consuming and The youngest volunteer would be approaching 85 years He implied that finding any person from the study still There was no doubt in the minds of either Dr. Evans or Dr. Maletskos that any radiation doses received by the volunteer patients would have been incons.equeytia1 to their health. willing t o discuss the study in detail with those interested. Either former professor would be

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How were t h e volunteers selected, was any screening method employed? There were established procedures which are described below for selection of volunteer subjects for the testicular irradiation experiments. Initial Selection o f Volunteer Subjects Prior t o the initiation of the radiation studies, a study of the effects of exogenously administered hormonal agents on the male reproductive system had been underway f o r seven years. discussed with "various inmates" (evidently about 25) and they were found t o be interested in such a program. After these initial discussions the other inmates became informed by word of mouth and/or observation on most d e t a i l s o f the experimental techniques. The following was the routine procedure f o r any man wanting to join the research program: The plan t o add radiation t o the study was 1) The man heard about the project from other inmate volunteers, or most usually, his cell mate, or as a result of the fact that he h.appened t o be a hospital worker. . 2 ) He submitted an interview request t o the investigating physician via t h e penitentiary hospital. 3 ) The investigating physician would then explain the program t o each volunteer individually and answer any questions, u p o n his next penitentiary vi sit. 4) If at this point, no problems were encountered and the volunteer was still interested he was placed on the "temporary'' program. Subsequent Volunteer Management 1) While on t h e "temporary" program the new volunteer collected seminal f l u i d once per week and had a physical examination. If the man had ever been identified as Catholic he was not accepted even on the "temporary" program until he had discussed the matter with a priest.If the priest affirmed that th'e man was not a Catholic, he was accepted into the program. 2)At the end of one month(or three. seminal fluid specimens) the investigating physician again talked t o the man. I f the sperm counts were normal, the seminal fluid was of normal volume and consistency, his health was good, he followed directions and caused no problems (disciplinary or medical) t o the hospital staff, and he still wished t o be- on the program,.he was accepted into the

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5. Please identify all legal claims, together with its status or outcome,. which have been filed against th'e U.S. government-as a result of the individual ' s participation in the experiments o r treatments described in the We have searched Department of Energy's tort claims records t o determine whether any claims have been filed as a result of individuals' participation in the tests described in our September 20, 1984, response. We have identified the following claims against the United States,filed with the Department of Energy, orits predecessor agencies, under the provisions of the Federal Tort Claims Act (FTCA). Other claims may have been filed directly with DOE contractors, investigators, and others who conducted or participated in these experiments, 1. Mary Sue Sexton - An administrative claim was f i l e d against the U.S. under FTCA on behalf of deceased child, Talmon Dwayne Sexton. Claim alleges negligence in treatment of plaintiff ' s minor child, Talmon Dwayne Sexton, for acute lymphoblastic leukemia a t Oak Ridge Associated Universities Medical Center. Claim i s pending. Associated Universities i n Circuit Court for Anderson County, The Court of Appeals affirmed. , NOTE: A similar claim (L-2728) was filed against Oak Ridge Court granted defendant ' s rnoti on.for summary j udgment . Ivan Dale Hetlund Hal Dean Waltz - The above plaintiffs each brought suit against the Atomic Energy Cornmi s s i on ( A E C ) , Energy Research and Devel opment Admi ni st ration(ERDA), (predecessors of Department of Energy) as well as the State of Oregon, Amos Reed, Hoyt Cupp, Dr. Daniel D. DiIaconi, Or. Carl G. Heller, a n d Dr. Mavis Rowley. prisoners a t Oregon State Penitentiary who participated i n an irradiation research program. The cases o f ' plaintiffs Mathena, Hetlund, Atkinson, Waltz, and Hignite were consolidated into one for the District of Oregon granted the United States ' motion t o dismiss the federal defendants, with prejudice in the.Mathena etal. case and in the Tyrell case. Case was dismissed by stipulation because the AEC and ERDA had nothing t o d o with funding the particular project complained of in The action brought by plaintiff

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volunteers were subjected to radiological exposure. Please identify the mostrecent experiment(s)in which healthy human Currently at Brookhaven National Laboratory,healthy human volunteers are used as controls in the development o f techniques and methods for the analysis and solution of medical problems. the same experimental procedures as were used for the patients. These techniques involve total body neutron activation,partial body neutron ments of total body nitrogen,calcium,or potassium can be made noninvasive ly in vivo to study the interrelationships among cancer, nutrition, and body composition.In addition,these techniques can be used t o measure whole body or organ burdens of toxic metals such as: cadmium, mercury, silicon,beryllium and lead.Funding for clinical studies involving cancer and aging is provided by NIH. A description of the research project is The controls were subjected to..

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following Whqle-Eody Radiation, " conducted by Dr. Eugene Saenger atthe Cincinnati General Hospital ? Was the AEC i n any way involved in the study, "Metabolism of Radiation No, Dr. Saenger's project was funded by DOD.

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8. Regarding SFS 1.001: what t e s t s and follow-up examinations were performed provide the basis for the statement that "none of the deaths were related t o plutonium exposure and there i s no evidence t o suggest that plutonium injection influenced the course o f the diseases .I' A table indicating the causes of death i s included i n SFS1.001, Fact Sheet 45. Most of these were obtained from autopsies or death certificates., Serial blood samples were drawn a t irregular intervals from 11 ofthe Puinjected individuals. The first sample was taken 4 hours after injection in all but one case. The longest post-injection time at which a reliable.blood sample was obtained was 46 days. illnesses, the results of the blood tests of these individuals revealed a common pattern. As i t moves out of the circulation, plutonium was evidently tracing fundamental processes that were little disturbed by the specific pat hol ogi cal conditions . In spite of the variety of the patient ' s The daily urinary excretion of each plutonium-injected individual was g i v e n through the end o f collections or through 138 days after plutonium injection. Additional excretion data on 3 plutonium injected individuals i s available through 155, 163, and 341 days. Data on the renal and gastrointestinal clearance of. plutonium were collected and are presented i n Table IX. The objective of this research project was t o determine the relationship between urinary pl utonium excretion and total body content of plutonium. This d a t a was urgently needed because plutonium was recognized as potentially dangerous a n d large-scale production of the material was imminent. I t was recognized that plutonium metabolism may vary depending on' the various illnesses of the patients,and this was confirmed during the diseases was an important factor in the results o f the study. The relationship between plutonium injection and the course ofthe

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WILL OBTAIN CONCURRENCES. PERFORMED ON HUHAN SUBJECTS IRMATION: SOW GJ EL DE OW PEARLMAN MW29 DO-1 EPW