Bureau of Medicine and Surgery Supplemental Report of Human Radiation Experiments 31 March 1994 (Includes Event Profiles for All Possible Human Radiation Experiments Identified)

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THE BUREAU OF MEDICINE AND SURGERY SUPPLEMENTAL REPORT OF HUMAN RADIATION EXPERIMENTS the Secretary of Defense (Atomic Energy) request for a DOD-wide review of Human Radiation Experiments. This review identifies medical department activities that might have conducted or sponsored human radiation experiments. Identified are the archives and record centers where records concerning such experiments might exist and a description of the steps taken to search those records. All efforts have been taken to include any studies which may involve exposure to ionizing radiation. As such, studies are included where exposure was received as part of, but not for the purpose of the study. The information in this report incorporates data available as ofMarch 23, 1994. Additional information and details of individual studies continues to arrive and will be consolidated into future reports. reporting all records of This is a supplemental report to the February 28, 1994 response to the Assistant to The Assistant to the Secretary of Defense (Atomic Energy) directed locating and (1 ) Experiments on individuals involving intentional exposure to ionizing radiation This category does not include common and routine clinical practices, such as established diagnosis and treatment methods, involving incidental exposures to ionizing radiation (2) Experiments involving intentional releases of radiation that (a) Were designed to test human health effects of ionizing radiation (b) Were designed to test the extent of human exposure to ionizing The scope of this guidance was interpreted to include research involving human test subjects in which the subjects receive exposure to ionizing radiation which they would not receive if they were not part of a study. Consequently this definition includes clinical research protocols where the patient receives exposure from diagnostic tests which are incidental but integral to the study. The following summarizes searches conducted, record retention policies and administrative controls for use of human test sub~jects:

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retention and disposal requirements. Guidance prior to 1985 has yet to be reviewed Briefly, present guidance states: SECNAVINST 5212.5C, 11 JULY 85, provides current guidance for records (1) Medical and dental research and development project files as well as preliminary. interim. and final reports are to be retained permanently. They are to be transferred to the nearest Federal Records Center after 5 years and offered to the National Archives Regional Administrator after 20 years. (2) Supporting records (excluding reports) are to be transferred to the nearest Federal Records Center after 5 years After being held for 10 years they are to be destroyed by the Federal Records Centers. These copies are to be destroyed after 5 years, or upon project completiodtermination, whichever is later Non-record copies of research project files are to be retained on board. Manual of the Medical Deoartment in 1951 Drovided formal guidance for conductine exoeriments using human use test subiects. Human Use Test orotocols were to be reviewed and rooroved by the Secretary of the Navy. Further guidance was issued in DOD and BUMED instructions in 1964, 1982. 1983,1984,1988 and -1989. In addition, from 1963 to 1975 the Nuclear Regulatory Commission reviewed and approved or disapproved all human uses of investigational radiopharmaceuticals in humans and all human use testing with radioactive material. research activities at various commands and documentation practices from 1944 to the present. They identified approximately seventeen activities where humans may have been exposed as part of a study. D. The reports at the Defense Technical Information Center (DTIC) were searched to identify applicable studies. Copies of research reports funded under a specific contract or budget line are supposed to be forwarded to DTIC upon completion of work. The DTIC computerized Title Index contains all reports (700,000) provided to DTIC since 1972 (Some of the reports reflect research performed prior to 1972, e g. work performed in the 1940's and 1950's, but not submitted to DTIC until after 1972). Reports provided to DTIC prior to 1972 are maintained on index cards. DTIC performed a search by key words of their computerized and card indexes. The search identified over 3,600 Titles representing Army, Navy, Air Force, Defense Nuclear Agency, Defense Atomic Support Agency, Atomic Energy and other US Agency work, and translations of foreign work. Review of the Titles, Abstracts and Reports identified six sponsored by the Navy. Search A search for instructions governing human use testing was conducted. The Navy Key researchers, both active duty and retired, were questioned concerning

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Radioactive Material Use Permits, was asked tq review Nuclear Regulatory Commission Licenses and Permits to identify activities authorized to use radioactivity on human test subjects, and provide an estimate ofthe time periods when various commands had active programs. In addition, copies of any curriculum vitae (CV) containing publications of studies on humans were requested Search is complete. F. The Nuclear Regulatory Commission (NRC) was asked via the Chief of Naval Operations, N-45, (Captain Malinoski, MSC, USN) to identify the location and number of licenses and protocols used in investigational radiopharmaceuticals. From 1963 to 1975 NRC reviewed and approved all protocols using investigational radiopharmaceuticals in humans. Search is pending. records from activities suspected of having performed studies. AI1 of the Regional Archives and Federal Records Centers have conducted searches for records from activities suspected of having performed studies which exposed personnel. Records are taken care of as follows: The Naval Environmental Health Center, manager of the medical department's Federal Records Centers and National Archives were queried to identify any (1) Personnel, medical, and clinical records go to the National Records Center in St. Louis. Clinical charts and personnel medical records are retained for 75 years. Records are filed by Service Number or Serial Number. St. Louis estimates aooroximatelv 28 million Navy medical records are held for t h e 1944-1994 time ( 2 ) Research and administrative records held at the Federal Records Centers are transferred to the National Archives after 25 years, where a decision is made to either purge or retain them. Information protected by the Privacy Act is purged, e.g. names of individuals. Only about 1-2 percent o f all records sent to the Regional Records Centers go into National Archives (legal cases, deeds, titles, etc.). The rest are experiments or clinical trials that involved exposure to human test subjects. Searches completed at all but two activities (NMRI and NMRU-2). at various activities. Search is pending. publications by author Search is pending. Each BUMED activity was tasked to search their records and report any CVs were requested from researchers to identify publications of work performed A list of possible researchers was compiled to allow a literature search for Records maintained at the Federal Records Center and National Archives, San Bruno, California of work performed by the Naval Radiological Defense Laboratory, 1955-1969, were physically reviewed by BUMED representatives.

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111. Findings. The results of the Bureau of Medicine and Surgery's review are provided A. Part I describes by activity the efforts to locate records, individuals consulted, records found and a list of studies by title. Included are studies involving human use test subjects, clinical protocols. prospective and retrospective clinical studies, and clinical case reports Studies were included if it was not clear if the subjects would have been exposed if not part of the study. B. Activities and studies listed on previous reports which further review indicated did not involve human testing have been deleted. C. Previously reported Titles of studies identified from CV but still pending review are D. Part I1 provides Information found in the course of our searches concerning studies at E. Part 111 includes Detailed information pertaining to each study identified in Parts I. and

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PART I: IDENTIFICATION OF ACTIVITIES THAT MIGHT HAVE CONDUCTED OR SPONSORED HUMAN RADIATION EXPERlMENTS I . Introduction-. Activities identified as having performed experiments or clinical studies involving exposure to humans are listed below. The summaries include a description by activity of types of work, time frame performed, efforts to locate records. individuals contacted, records found, and summaries of experiments and studies. The Naval Medical Research Institute established the Radiation Technology Division which did basic animal radiobiology and support work for atomic weapons testing. The division was active from the early 1940's until about 1960. Dr. Cronkite stated that doctors stationed at NMRI from 1946 until his transfer in 1954 were not allowed to see patients in the hospital. We have not ruled out that some physiology and medical tests may have occurred in collaboration with the hospital (1944-1946 and 1954-1960). Captains Erhardt and Gaugler stated that instances of their investigators conducting work on humans should be very rare, as the laboratory has been a basic animal research facility. Naval Medical Research Institute (NMFU), Bethesda, MD. Efforts to locate human radiation experiment records: Queried knowledgeable individuals as to the type of work performed at (2) Searching through technical documents available in the NMRI library Searched through DTIC's computerized listings and index card records. Queried Federal Records Centers for NMRI records. (5) Queried Federal Archives for NMRI records. Searching Medicus Indicus for publications by NMRl investigators. Searching NRC License File for authorization to do human use testing Searched Navy Environmental Health Center's NRC License File for CV of Dr. Vic Bond, Brookhaven National Laboratory, (5 16) 282-3332 Dr Eugene Cronkite, Brookhaven National Laboratory, (5 16) 282-7538

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Captain Bob Gaugler, MSC, USN, NMRI Captain Doug Erhardt, MSC, USN, Executive Oficer, NMRI Bob Plowman, Joseph Sheehan, Dan Bennett, National Archives and Federal Records Center, Philadelphia, (215) 597-5694/9753 were destroyed Aug. 1992 by the Federal Records Center, St. Louis. cubic feet of records including some records from the Research Division at Copies of all technical reports are located in the NMRI Library No records were located in the Regional Archives Radioisotope License File on file at Navy Environmental Health Center St. Louis Records Center stated one cubic foot of logs dated 1944-1956 Federal Records Center at Suitland, Maryland holds approximately 475 List of Experiments or Possible Experiments: Radioactive Isotopes, The Blood-Tissue Exchange and Excretion of Antimony in Humans Given a Single Dose of Tartar Emetic." 1944 2. "Decreased Free Fraction of Thyroid Hormones After "Biological Studies of Antimony Compounds Containing 3. "Nitrogen Gas Exchange in the Human Knee." 1985 "Tracer Gas Kinetic Studies for Decompression Table Design." "Absorption of X-rays by Tissues of the Head and Neck." B. Naval Hospital St. Albans. Naval Hospital St. Albans was disestablished in 1973. St. Albans was the major Navy cancer treatment hospital on the East Coast in the

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late 1940's to early 1960's. In 1952 a medical physicist was assigned to help physicians develop therapeutic use of radioisotopes. The hospital had a radon farm constructed, but the unit was never used. Suspect clinical applications were developed using Sr-90, Efforts to locate human radiation experiment records: at St. Albans to determine type of work. prepared by individuals at St. Albans. stationed at St. Albans. Interviewed individuals previously stationed or knowledgeable of activities Queried Federal Records Centers for the presence of records Queried National Archives for the presence of records Searched DTIC index and card files by key words for papers or reports Searched Medicus Indicus for papers published by individuals while Searched the NRC Radioisotope License File at the Navy Environmental (7) Queried NRC to search their license files. Captain Horace Chester Dudley, MSC, USN (Ret) Captain Jim Malinoski, MSC, USN Robert Morns, National Archives Boston (617) 647-8100 Martin Kabakoff, Federal Records Center, Boston (617) 647-81 10 Lee Remero, Federal Records Center, New York (201) 823-7161 Karen Lucus, Federal Records Center, New York(201) 823-5487 Gregory J. Plunges, National Archives, New York (212) 337-1300 William Seibert, National Personnel Records Center, St. Louis, (3 14) 538-4216 Joseph Sheehan, National Archives, Philadelphia Griff Plunges, National Archives, New York Human radiation experiment records found: (1 ) No experiment records found in the Archives

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and a 10 page command history. No experimental results or clinical trial information was found according to M r Plunges. Center, St. Louis total 3,249 cubic feet for the years 1943-1973. identified several titles but work could be animal studies. National Archives, New York, holds 1.5 cubic feet of St. Albans records. Patient's charts and military health records located in the Federal Records Open scientific literature may hold published papers. Another search NRC Archives may hold some records of the licensed activities versus List of Possible Experiments: individuals stationed St. Albans identified the following titles. The articles have yet to be reviewed to see if they fall within the scope of of the tasking A search by authors ofthe Medicus Indicus for articles published by "Studies of the Metabolism of Gallium. Deposition in and Studies of its Deposition in and Clearance from Alkaline Phosphastase and Calcification in Vitro." 1953 "Studies of the Metabolism of Gallium. Effect of Gallium on "Pharmacological Studies of Radiogermanium Inhalation of "Studies of the Localization of Radioactive Gallium in primary purpose has been to investigate disease endemic to Africa and the Middle Naval Medical Research Unit No. 3, Cairo, Egypt. The research unit's Efforts to locate human radiation experiment records: of key words. Manual reviews of titles and abstracts conducted of key word search to identify possible human radiation experiment records Used the Defense Technical Information Center's (DTIC) computer search

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(2) Queried Federal Records Centers (3) Queried Federal Archives. Medical Records of military located at Federal Records Center St. Louis Tasked command to search their records Captain Ed Flynn, MC, USN, Commanding Oficer, Research and Development Mr. Rich Boyland, National Archives, Suitland, MD (301) 763-1083 Ms. Velicia Chance, Federal Records Center, Suitland, MD (301) 763-7430 Ms. Millie Sturate, Federal Records Center, Suitland, MD (202) 433-421 7 Mr. Jim Smith, Federal Records Center, Fort Worth TX (Port of entry for East jks William Seibert, National Personnel Records Center, St. Louis, (3 14) 538-4216 Coast foreign generated US records.) (1) Copies of reports at NMRU 3, Cairo. Detailed records for only two studies still exist. (2) Two reports in DTIC files. Radioisotope License File on record with the Navy Environmental Health List of Experiments o r Possible Experiments: Radiologically Demonstrable Calcification to Eggs in Tissues and Passage of Eggs in Urine." 1978 "Calcification of Schistosoma Haematoeium Eggs: Relation of "Urinary Schistosomiasis in Egypt: Further Radiological "Radioactive Renography in Schistosomal Obstructive

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Laboratory Studies in Egyptian Cases." 1956 Splenectomy for Bilhanial Hepatosplenic Fibrosis Dehydrogenase "Schistocolonic Polyposis: Clinical, Radiological and "Schistosomiasis of the Liver, Clinical, Pathologic and "Acute Haemolysis With Ambilhar Treatment in Glucose-6- "Changes in Hepatic Blood Flow and Blood Volume After Uropathy as Determined by Iodine-131 Hippuran Renography Location and Time of Study." 1978 "Efficacy of Medical Treatment of Schistosomal Obstructive "Some Effects of Louse-Born Relapsing Fever on the Function "Urinary Schistosomiasis: A 5 Year Clinical Radiological arid 13. "Treatment of Chronic Urinary Salmonella Carriers." 1970 "Intestinal Protein Loss in Schistosomal Polyposis of the "Chronic Urinary Salmonella Carriers With Intermittent "Histologic and Lymphangiographic Studies in Patients With "Urinary Blood Loss in Schistosoma Haematobium Infection "Blood Loss in Chronic Schistosoma Mansoni Infection in

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"Chromium Red Cell Half-Life in Severe Iron Deficiency Concentration in Urinary Schistosomiasis." 1971 22. "Symptomatic, Radiological and Functional Improvement Following Treatment of Urinary Schistosomiasis in Egypt." 1967 24. "Bilhanial Splenomegaly and Refractory Anemia." 1966 "Hydronephrosis, Bacterium, and Maximal …