DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995. * * * * STAFF MEMORANDUM * * * * TO: Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: June 7, 1994 RE: Department of Health and Human Services (HHS): Update This staff memorandum contains the following: (1) an update on the activities undertaken by staff and HHS pursuant to the Committee's requests and direction at the last meeting; (2) an update on related HHS activities; (3) an addendum correcting a statement and providing additional information about the Air Force Iodine 131 study in Alaska discussed in the HHS preliminary report provided to the Committee on May 13, 1994 (Tab H of the briefing book for the May 18-19 meeting); and (4) the staff's recommendation for future HHS-Committee collaboration. I. Update on Committee Requests and Recommendations At the last meeting,' the Advisory Committee endorsed two general actions with regard to HHS. In addition, the Committee staff requested 14 specific actions on May 2 and 11 specific actions on May 25 from HHS. (A) Search for High-Level Policy and Interagency Relationships First, the Committee requested that HHS locate and retrieve higher-level documents that evidence policy and procedures related to human radiation experiments or that demonstrate interagency coordination, cooperation, and cosponsorship or finding of human experiments or investigators.1 To this end, HHS and the Committee staff have undertaken several activities. On June 2, the staff met with HHS representatives and began the process of defining a search for higher level documents. The National Institutes of Health (NIH) reports that its Institutes have indicated that they could have a complete set of these Advisory Council minutes. These minutes, as well as any existing Annual Reports from the Institutes, will be made available to the Committee. The Committee staff believes that, by using the Advisory Council minutes, the Annual Reports, organizational charts and histories, and its historians, HHS should be able to begin identifying key offices and HHS provided the staff with documentation related to the 18 experiments sponsored by antecedent Center for Devices and Radiological Health (CDRH) organizations and identified by the Food and Drug Administration (FDA), which were previously mentioned in the HHS Preliminary Report. This FDA summary is not included in its entirety in the briefing book for this meeting because of its size, but we have attached as Exhibit One the cumulative list of these experiments and the grantee institutions. HHS also carried out an extensive search of records, documents, and materials related to Dr. George E. Burch, the subject of a Boston Globe article on human radiation experiments. Dr. Burch was the principal investigator for several PHS supported research projects while at Tulane University (Charity Hospital). HHS reports that very few of these projects involved human radiation, and the projects that do involve human radiation experiments appear to be radioisotope studies. Dr. Burch apparently authored approximately 750 articles, which are being reviewed by NIH staff. In addition to these articles, 52 boxes of his personal papers donated to the National Library of Medicine are being searched by PHS. Furthermore, NIH is seeking to identify any PHS supported research conducted by Dr. Burch's collaborators 50 that the scientific literature related to this research can be reviewed to determine whether any of these investigations involved any human radiation research. Since the last meeting, NIH reviewed 1,187 boxes at Suitland Federal Records Center. These boxes were part of accessions to the records center with SF 135s that had any of the 11 key words related to radiation (see HHS Preliminary Report). Twenty NIH staff, including two experts in radiation, hand-searched each box. The great majority of the boxes (1,180) contained patient record files or components of patient records like X ray films, associated X ray reports, electrocardiograms, and autopsy reports. Six boxes of records of the National Cancer Institute contained books and other published materials (e.g., National Research Council reports), or memos and other documents (e.g., meeting materials from the National Cancer Board) from the late 1970s and early 1980s. One box of records from the National Institute of Dental Research contained memos and documents from the 1960s. II. Addendum One to Preliminary Report The Indian Health Service (IHS) located (although not by a formal search strategy) information related to an Air Force study conducted on the Athapascan Indians of interior Alaska and the inland Eskimos. IHS provided some information to the Committee staff on this study, which was included in the preliminary report on HHS in the briefing book for the May 18-19 meeting. A portion of two sentences contained in the information provided by IHS was incorrect.3 The following correction is based on information provided to staff from IHS, the Air Force, and the Navy. (A) Correction On page 18 entry (11) of the HHS Preliminary Report prepared by Committee staff, the last two sentences of the paragraph, which contain the incorrect information (in italics) read: Although a higher number of microcuries is used for 1-123, the amount of radiation effectively delivered by the 1955 Alaska diagnostic tests were ten times that used currently, due to the shorter half-life and weaker type of radiation of l-123. 1-131 is the current iodine nucleotide to ablate the thyroid as a treatment of, for instance, thyroid cancer; the ablation dose is 30 milicuries, about 1Staff notes that the initial HHS search for records related to human radiation experiments does not appear to have been inconsistent with the preliminary search strategy taken by other members of the Interagency Working Group. However, the Advisor Committee has recommended that HHS shift its search emphasis as a necessary compliment to its original search strategy. 3 In addition, the ablation dose (deleted in the corrected version) had been incorrectly calculated. 3 EXHIBIT ONE EXHIBIT ONE Cumulative Listing of Relevant Human Radiation Experiments to May 30 1974) sponsored by Antecedent CDRH Organizations 1) Gonad exposure in Medical Radiography: A Handbook of Scatter/Primary Ratios BRD/DMRE Contract Report PH 86-68-63 (May 1971) Authors: R. H. Morgan and E. F. Gehret; The Johns Hopkins University Sponsored by: National institutes of Health; Bureau of Radiological Health Purpose: To study the scatter of x-radiation to the gonads from diagnostic radiology ... involved intentional exposure to x rays for non-clinical purposes Subjects: A total of 30 healthy individuals, including 6 children; ages 4 to 45 2) Minimal Dosage of Iodide Required to Suppress Uptake of Iodine-131 by Normal Thyroid Science (October 29, 1962) Authors: K. M. Saxena, E. M. Chapman, and C. V. Pryles; Harvard Medical School; Massachusetts General Hospital; Boston University School of Medicine Sponsored by: Division of Radiological Health, Research Branch Purpose: To study the use of sodium iodide as a countermeasure for radioiodine uptake ... involved intentional administration of iodine-131 for non- clinical purposes Subjects: 70 mentally retarded children at a long-term care facility, ages l to 11 3) Reduction of Thyroid Irradiation From 1-131 potassium Iodide Journal of the American Medical Association (June 19, 1967) Authors: M. Blum and M. Eisenbud; New York University Medical Center Sponsored by: Defense Atomic Support Agency; National Cancer Institute; Bureau of State Services (Grant ES 00014) Purpose: To study the use of potassium iodide as a countermeasure for radioiodine uptake ... involved intentional administration of iodine-131 for non-clinical, purposes Subjects: 62 healthy adults, ages 21 to 72 4) Three papers by the same investigating group: Veterans Administration Hospital (Hines, Illinois) Purpose: To study the removal of radionuclides in humans by enhanced salivation (for Sr-85 and Ca-47) and by chelating agents (for Sc-46 and Zn-65) ... involved intentional administration of tracer amounts of the named radionuclides for non-clinical purpose Secretion of Sr-85 and Ca-47 in Human Saliva Proceedings of the Society for Experimental Biology and Medicine (Volume 118, 1965) Authors: J. Samachson, V. Vankinscott and H. Spencer Sponsored by: Division of Radiological Health (Grant RH 00222) Subjects 19 patients, ages not specified Removal of Scandium-46 in Man Health Physics (Volume 11, 1965) Authors: H. Spencer and B. Rosoff Sponsored by: Atomic Energy Commission; Division of Radiological Health (Grant RH 00222) Subjects: 16 adult patients, ages 45 to 86 Effect of Chelating Agents on the Removal of Zinc-65 in Man Health Physics (Volume 12, 1966) Authors: H. Spencer and B. Rosoff Sponsored by: National Cancer Institute; Division of Radiological Health (Grant RH 00222) Subjects: 5 adult patients, ages 56 to 73 5) Precision of Assay of Whole-body Potassium in Man National Academy of Sciences Publication 1598 (1969) Authors: C. E. Miller, A. P. Remenchik and W. V. Kessler; Argonne National Laboratory; Loyola University; Purdue University Sponsored by: Atomic Energy Commission; Public Health Service; American Medical Association; Division of Radiological Health (Grant RH 00283) Purpose: To study the accuracy of whole-body counter techniques for the measurement of potassium in man ... involved intentional administration of potassium-42 for non-clinical purposes Subjects: 44 healthy individuals, ages not specified 6) Two papers by the same investigating group: Veterans Administration Hospital (Boston, Massachusetts); Boston University; Tufts University Purpose: To study the concentrations of potassium and sodium in body composition ala involved intentional administration of sodium-42, potassium-42, bromine-82 or hydrogen-3 (tritium) for non-clinical purposes Body Composition and Serum Electrolyte Concentrations Journal of Applied Physiology (Volume 18, 1963) Authors: E. A. Boling and J. B. Lipkind Sponsored by: Division of Radiological Health (Grant RH 00104) Subjects: A total of 68 individuals; 65 adult patients and 3 Healthy adults; ages 24 to 71 Simultaneous Assay of K-42, Na-24 and Br-82 in Body composition Measurement Journal of Applied Physiology (Volume 18, 1963) Authors: E. A. Boling, E. Rossmeisl, R. McLean, H. Alpert, R. Gardner, M. Halpin and J. B. Lipkind Sponsored by: Division of Radiological Health (Grant RR 00104) Subjects: A total of 71 individuals; 67 patients and 4 healthy individuals; ages not specified 7) Whole and Partial Body Radiation Therapy for palliation of Cancer Patients Material prepared in 1971 for Senator Gravel by the American College of Radiology Prepared by: Z. L. Saenger; University of Cincinnati College of Medicine Sponsored by: Department of Defense; peripheral mention of support from a Bureau of Radiological Health training grant to provide stipends for trainees doing research on dosimetry Purpose: To determine the effects of radiation treatment in improving survival of patients with far-advanced cancer; and to understand the effects of radiation on the patients a.a involved intentional treatment with ionizing radiation (cobalt-60?) to study a new clinical approach Subjects: 82 treated patients, including 3 children, ages 9 to 81; selected on the basis of type and extent of tumor 8) Six papers by the same investigating group: Bureau of Radiological Health; Cincinnati General Hospital Purpose: See each paper. Evaluation and Dosimetry of a 99mtc--SN-MAA Lung Imaging Agent (work published after May 30, 1974) Health Physics (Volume 30, 1976) Authors: P. H. Robbins, P. A. Feller and H. Nishiyama Sponsored by: Food and Drug Administration (Contract FDA 73-203) Purpose: To estimate the radiation dose to tissue from a new radiopharmaceutical used as a lung-imaging agent ... involved intentional administration of technetium-99m for non-clinical purposes, except in one case for a comparative clinical purpose Subjects: A total of 5 adults; 4 healthy individuals and l patient; ages 25 to 48 A Comparison of 1-123 and 1-131 for Thyroid Imaging Using Various Collimator International Journal, of Nuclear Medicine and Biology (Volume 1, 1974) Authors: II. Nishiyama, A. B. Ashare, A. Shafia, E. L. Saenger and V. J. Sodd Sponsored by: None identified Purpose: To compare five collimator and two radionuclides to determine best clinical combination ... involved intentional administration of iodine-123 and iodine-131 to study a new clinical technique Subjects: 47 patients, ages not specified Evaluation of Clinical Value of 1-123 and 1-131 in Thyroid Disease Journal of Nuclear Medicine (Volume 15, 19,73) Authors: H. Nishiyama, V. J. Sodd, R. A. Berke, and E. L. Saenger Sponsored by: None identified Purpose: To compare two radionuclides to determine the radionuclide of choice aaa involved intentional administration of iodine-123 and iodine-131 to study a new clinical technique Subjects: 24 patients, ages not specified Lace of Specificity for Detection of Breast Lesions with Radioactive Cesium Chloride (work published after May 30, 1974) Surgery, Gynecology & Obstetrics (Volume 143, 1976) Authors: H. Nishiyama, M. Moskowitz, E. L. Saenger, J. T. Lewis, and R. G. Hoops Sponsored by: None identified Purpose: To test the feasibility of using cesiuin-131 for detection of breast lesions a.. involved intentional administration of cesium-131 for study of a new clinical technique Subjects: 29 adult patients, ages not specified The Use of Radioactive Cesium Chloride for Imaging of Malignant and Benign pulmonary Lesions (work published after May 30, 1974) Surgery, Gynecology & Obstetrics (Volume 141, 1976) Authors: H. Nishiyama, J. T. Lewis, V. J. Sodd, and E. L. Saenger Sponsored by: None identified Purpose: To study the efficacy of cesium-129 as a pulmonary imaging agent ... involved intentional administration of cesium-129 to study a new clinical technique Subjects: 56 patients, ages not specified Cesium-129 Myocardial Scintigraphy to Detect Myocardial Infarction Circulation (Volume 43, 1973) Authors: D. W. Romhilt, R. J. Adolph, V. J. Sodd, and four others. Sponsored by: NIH NHLI 71 2489; PHS Grant HE-6307; Southwestern Ohio Heart Association; VA Training Grant TR-200. Purpose: To study the efficacy of cesium-129 as a myocardial imaging agent ... involved intentional administration of cesium-129 to study a new clinical technique Subjects: 50 patients, ages not specified 9) A Sensitive technique for Measuring Thyroidal Uptake of Iodine-131 Journal of Nuclear Medicine (Volume 8, 1967) Authors: II. N. Wellman, J. G. Kereiakes, T. B. Yeager, G. J. Karches and E. L. Saenger; Division of Radiological Health; University of Cincinnati College of Medicine Sponsored by: Division of Radiological Health Training Grant 4TIRH36-04; University of Cincinnati College of Medicine Purpose: To demonstrate the efficiency of a dual crystal system for thyroid uptake studies ... involved intentional administration of iodine-131 to study a new clinical approach Subjects: 52 patients, ages not specified 10) comparison of Technetium-99m and Iodine-123 Imaging of Thyroid Nodules: Correlation with Pathologic Findings (work published after May 20, 1974) Journal of Nuclear Medicine, (Volume 31, 1990). Authors: Z. Kusic, D. V. Becker, E. L. saenger, P. Paras, and three others. University Hospital, Zagreb, Yugoslavia; CDRH/FDA; and other institutions. Sponsored by: U.S.-Yugoslav Joint Fund for Scientific and Technological Cooperation and DHHS/FDA Grant #02-660-F. Purpose: To conduct comparative studies on two thyroid imaging agents to clarify differences...involved intentional administration of technetium-99m and iodine-123 to study a new clinical technique. Subjects: 316 patients, ages not specified. Listing of Grantees & Contractors Performing Possible an Radiation Experiments with PHS Radiological Health Support(1962-1989) 1. University of Rochester Rochester, New York 2. University of Louisville Louisville, Kentucky 3. Johns Hopkins Medical Institutions Baltimore, Maryland 4. Universities Associated for Research and education in pathology Bethesda, Maryland 5. Loyola University Chicago, Illinois 6. Research - Foundation of SUNY Buffalo, New York 7. Mayo Clinic Rochester, Minnesota 8. Bowman Gray School of Medicine Winston Salem, North Carolina 9. University of Pennsylvania Philadelphia, Pennsylvania 10. University of Pittsburgh Pittsburgh, Pennsylvania 11. Manhattan College Bronx, New York 12. University of North Carolina Chapel Hill, North Carolina 13. Purdue University Lafayette, Indiana 14. New York University New York, New York 15. Massachusetts General Hospital Boston, Massachusetts 16. Vanderbilt University Nashville, Tennessee 17. University of Iowa Iowa City, Iowa 18. University of Tennessee Knoxville, Tennessee 19. Columbia University New York, New York 20. University of Chicago Chicago, Illinois 21. Texas A & M university College Station, Texas 22. Hunter College New York, New York 23. Harvard University Harvard Medical School Boston, MA 24. Boston University School of Medicine Boston, MA 25. Veterans Administration Hospital Hines, IL 26. Tufts University Boston, MA 27. Veterans Administration Hospital Boston, MA 28. University of Cincinnati Cincinnati, OH 29. University of Miami Miami, FL TAB L Staff Memorandum--Update on Methodological Case Studies ("Cincinnati Experiments," "Plutonium Injection Experiments," "Green Run.") DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995.