Bureau of Medicine and Surgery Supplemental Report of Human Radiation Experiments as of 29 April 1994

Page 1

THE BUREAU OF MEDICINE AND SURGERY SUPPLEMENTAL.REPORT OF HUMAN RADIATION EXPERIMENTS AS OF 29 April 1994 the Secretary of Defense (Atomic Energy) request for a DOD-wide review of Human B. This report identifies 70 additional studies and provides missing information for studies previously reported. There is no evidence of secret human testing or use of nonvolunteers. It also identifies additional individuals contacted and locations of records not known at the time of the 31 March report. Current total of BUMED studies identified is This is a supplemental report to the March 31, 1994 response to the Assistant to C. Information is sorted by activity in the same order as the March 31 report. Study identification numbers are sequential beginning with the last number submitted in the 31 11. -. The following search activities have been completed since the last report: A. Navy representatives manually searched the records at the Federal Personnel Records Center, Saint Louis. Search included records for Naval Medical Research Center, Naval Hospital and Naval Submarine Base, Groton; Naval Hospital Chelsea; Naval Hospital St. Albans; Naval Hospital and Naval Medical Research B. The two activities,NMRI and NMRU-2, have completed searching for documents. A11 activities have now completed their local searches. The literature search by author is now approximately 80-90 percent The Nuclear Regulatory Commission's search of the license file is still summarized below. This was an extensive 4-day file search of lL6boxes by two 0-6 radiation health officers responsible for coordinating BUMED's HRRR research efforts The results of the manual search at the Federal Records Center are 1. Records from Groton were searched to see if the individuals participating in the radium application to the nasal pharynx could be identified.

Page 2

(a) Medical records for approximately sixteen names taken from a Memo directing the men report for radium treatments were requested. Approximately eight records were found. Of these only one had an entry, and it was indirect, indicating receipt of radium treatment. This entry reported an adverse reaction from a radium treatment administered a few days earlier. The original treatment was not documented. (b) A Memo in the General Correspondence file identified a doctor who had not responded to radium treatment and recommended disqualification from submarine duty. This individual's medical record did not document his having received a (c) X-ray log books from February 1944 through August 1947 showed repeated entries, one or two a week, of "Therapy." Medical records for approximately twelve of these individuals were found. Each had records of having received x-ray therapy for acne on the dates corresponding to the log books. No record of nasal pharangeal irradiations were found. (d) Given the lack of records of radium treatment remaining in the files, particularly for individuals known to have undergone the procedure (other than incidental notations on records that are retained) seems to indicate such treatment was probably annotated on nonstandard forms other than medical records and which were not retained when the files enter records centers. 2. The General Correspondence files for Naval Hospital St. Albans (a) A 1950 letter from the Bureau of Medicine and Surgery denying a request to use human test subjects in a clinical trial. This confirms that a review mechanism was in place prior to the 1951 entry in the Manual of the Medical Department requiring Secretary of the Navy approval for use of human test subjects. (b) A copy of a research proposal form BUMED98 (Rev. 10/49) stating 3. The files labeled "Special Studies" for Naval Hospital Chelsea were tumor board records. where information was unknown or titles of papers were known but the papers had not been reviewed. In addition, new titles identified in the author search, reported by activities or identified during the manual search at the national archives are abstracted. The abstracts are grouped by activity and numbered in the sequence found. The following updates abstracts identified in previous reports

Page 3

Location: Evangelical Deaconess Hospital, Cleveland Ohio. This was & a N a w study. The Name of the principle author was the same as a Naval researcher of the same time period. Article was identified through our author search and listed on earlier report prior to obtaining a copy of the Sponsors: This was not a Navy study. Purpose: .To study the use of radiation (80 R exposures) to stimulate menstruation and to treat sterility in women. Category: Other research. Records: Obstetrics and Gynecology V9N2, Feb 57, p. 175-83.

Page 4

Studv #NMRI-07; Studies of Radiogallium as a Diagnostic Agent in Bone Location: NMRI and Naval Hospital Bethesda Subjects: 18 cancer patients with bone lesions. Purpose: To demonstrate the detection of bone lesions using Gallium-72. Category: Other, clinical research. Records: NMRI, Project NM 007 081.06.09 Journal of Laboratory and Clinical Medicine, February 1951,

Page 5

Studv #NMRI-OS: Urinary Excretion of Gallium Location: NMRI and Naval Hospital Bethesda Subjects: 50 cancer patients. Purpose: To evaluate the urinary excretion rate of gallium from cancer Category: Other, clinical research. Records: NMRI Research Report Project NM 007 081.06.11 Journal of Laboratory and Clinical Medicine 37: 676, 1951.

Page 6

Studv # NMRI-9: Use of Radioactive Hydrogen for Measurement In Vivo of Total Body Water Location: Naval Medical Research Institute, Bethesda, Md. Purpose: To determine if Tritium could be used to measure total body Category: Other, clinical research. Records: NMRI, Project X-191, Report No. 5

Page 7

Studv # NMRI-10: Biological Studies of Antimony Compounds Containing Radioactive Isotopes: Evaluation of the Rhodamine-B Method for the Assay of Antimony in Biological Samples Location: Naval Medical Research Institute, Bethesda, Maryland Purpose: To compare the determination of antimony concentration in blood as determined chemically compared to determined radisotopically. Category: Other, clinical research. Records: NMRI Research Project X-514,Report No. 2

Page 8

Studv # NMRI-11: Body Fluids in Hypertension and Mild Heart Failure Location: Naval Medical Research Institute and Naval Hospital Bethesda Purpose: The purpose of the study was to determine whether useful information could be obtained in patients with congestive failure, using radiosulfate as a measure of the extracellular fluid volume. A reliable and practical method for measuring extracellular fluid would be a great aid in the diagnosis and management of cardiac patients, as well as a useful adjunct to the study of the pathologic physiology of congestive Category: Other, clinical research. Records: Research Report, Project NM 007 081.16.04

Page 9

S t u d v # : Measurements of Gaseous Exchange in Connection with Aviation and Deep Sea Diving by Techniques Employing Location: Naval Medical Research Institute, Bethesda Maryland Purpose: To examine the relationship between regional and whole body uptake of inert gases, and to study the basic principles of cardiac output and functional lung surface measurements. Category: Other, military application, deep sea diving. Records: NMRI Research Project X-43,Reports No. One and Two Bulletin of Mathematical Biophysics, Volume 6,1944,p. 133-139 "On the Theory of Blood-Tissue Exchanges: 111. Circulation and Inert-Gas Exchanges at the Lung with Special Reference to Saturation", Bulletin of Mathematical Biophysics, Volume 6,

Page 10

B. Naval Hospital St. Albans. Minutes of a November 1951 staff meeting indicate the radioisotope laboratory would soon be in operation and administrated by a radioisotope committee on the local level. October 1952 correspondence to Burned requesting authority to procure radioisotopes listed the members of the Radioisotope Committee to include the Chiefs of Medicine, Surgery, Radiology, Laboratories, Oncology and Head of the Radioisotope Laboratory. Current License Studv #NHSTALB -01: Studies of the Metabolism of Gallium. Deposition in and Clearance from Bone Location: Naval Hospital, St. Albans Subjects: NONE : THIS IS AN ANIMAL STUDY

Page 11

ALB-02: Gallium Studies of its Deposition in and Clearance from Bone Location: Naval Hospital, St. Albans Subjects: NONE, THIS IS AN ANIMAL STUDY. Purpose: Analyzed the deposition and clearance of Gallium from bone. Category: Other Research. Records: Research Report Project NM 007 081.06.12 of 25 June 1952.

Page 12

m d v #NHSTALB -03: Studies of the Metabolism of Gallium. Effect of Gallium on Alkaline Phosphatase and Calcification in Vitro Location: Naval Medical Research Institute (NOT St Albans. Dudley had transferred to St Albans by time paper was published.) Subjects: None, animal study. Purpose: Studied the metabolism of gallium. Category: Other research. Records: Research Report Project NM 007 081.06.13 Vol I I , 5 Feb 1953

Page 13

Stud-TALB-04: Pharmacological Studies of Radiogermanium Inhalation of Dusts Location: Naval Hospital, St. Albans Subjects None, this was an animal study.

Page 14

Studv#NHSTALB-06: Therapy of Multiple Myeloma with Radioyttrium Location: Long Island Jewish Hospital (Study included because H.C. Dudley was believed to still be on active duty at Naval Hospital, St Sponsors:Leukemia Society, American Association for Cancer Research Subjects 11 multiple myeloma patients Purpose: Clinical trial using radioyttrium to treat bone lesions. Category: Therapy research. Records: Journal Laboratory and Clinical Medicine, Volume 59, No. 6,

Page 15

Gallium in Bone Lesions." Location: NAVAL HOSPITAL ST. ALBANS Purpose: Ga 72 was administered to patients forty eight hours before surgery for removal of cancer from bone tissue. Category: Therapeutic Treatment

Page 16

Predisposition to Radiation Illness to Other Clinical Findings in Patients Location: NAVAL HOSPITAL ST. ALBANS Sponsors: Joint project with National Naval Medical Center, Naval Medical Research Institute Subjects: 20 radiation therapy patients. Purpose: To investigate the factors responsible for the natural resistance of man to general and local effects of ionizing radiation. The occurrence of radiation sickness will be carefully observed in patients undergoing radiation therapy. Patients will receive only those dosages indicated for disease in question. Threshold dose levels of x-ray for the production of the various symptoms and changes will be determined with due consideration of field size of the irradiated area, over-all exposure time, section of the body and disease for which the patient bas been irradiated. Correlation of these clinical data with urinary keto-steroid excretion is contemplated for a later phase of this study. Category: Other, clinical research. Records: Naval Hospital St. Albans, General Correspondence Files, Federal Records Center, St Louis

Page 17

(Vit C.V.P.) in Conjunction with vitamin C on Skin Erythemas Caused by Radiations from Radioactive Substances." Project NM 007 086.10 Location: NAVAL HOSPITAL ST. ALBANS Researchers: Paul K. Kline, Wayne L. Wright use volunteers. Request was denied by BUMED. Authorization was made to test the cream on patients being treated in the normal routine. 5 radiation therapy patients. Note: Original proposal was to Purpose: To see if the skin tolerance and recovery could be enhanced by application of a vitamin enriched salve. If successful this would increase the skin tolerance and allow higher doses to be delivered to the patients Category: Other, clinical research. Records: General Correspondence files, Naval Hospital St. Albans, Federal Records Center, St. Louis.

Page 18

C. Naval Medical Research Unit No. 3, Cairo, Egypt. Relation of Radiologically Demonstrable Calcification to Eggs in Tissues and Passage of Eggs in Urine Location: Naval Medical Research Unit No. 3, Cairo, Egypt. Subjects: 25 Egyptian patients. Purpose: Diagnostic x-ray studies showing calcification in the bladder was correlated to the number of parasite eggs being passed in the urine. Purpose was to be able to determine the extent of the disease using x-rays versus urine Records: Defense Technical Information Center, Document No. AD A 0 61

Page 19

Studv # NMRU3-02: Urinary Schistosomiasis in Egypt: Further Subjects: 153 Egyptian male patients. Purpose: To study the frequency and causes of Urinary Schistosomiasis in the local population using urograms. Category: Incidental Diagnostic Records: Defense Technical Information Center Document No. AD A003

Page 20

D. National Naval Medical Center, Bethesda, MD. Studv #NNMC-01: Preliminary Report on the Use of Use of Gallium in Clinical Tracer Studies. Subjects: 63 cancer patients. Purpose: To evaluate Gallium-72 as a possible diagnostic tool in the determination of the spread of primary bone tumors to areas other than the primary site and determine the site and extent of early bone metastasis from malignant lesions in soft tissues. Category: Other research.

Page 21

Subjects: Approximately 40 patients. Purpose: Paper summarizes the treatment results of patients treated at Category: Other, Report of patient studies. Records: Medical Annals of the District of Columbia 24(12), Dee 1955,

Page 22

Study #NNMC-05: Evaluation of Pancreatic Exocrine Function and Intestinal Absorption With Radioactive Fat Purpose: Development and analysis of a diagnostic test which uses fat tagged with radioiodine to evaluate a deficient pancreatic exocrine function, or errors in alimentary absorption. Category: Other, clinical research. Records: United States Armed Forces Journal 8(5), May 1957, p 668-72.

Page 23

Studv #NNMC-06: Present Status of Radioiodine in Thyroid Disease Subjects: Several hundred patients. Purpose: Paper provides an overview of the treatment of thyroid disease at NH Bethesda and results. Category: Other, overview of clinical results. Records: Medical Annals of the District of Columbia 25(9), Sep 1956, p.

Page 24

S- The Use of Radioisotopes in Diagnostic Hematologic Procedures. I. The Application of the B-12 Co-60 Test in the Diagnosis of Macrocytic Anemias and Malabsorption States Subjects: 14 male and female patients ranging in age from 36 to 82. Purpose: To use Co-60 labeled vitamin B-12 to study peripheral neuropathies, macrocytic anemias, and certain malabsorption syndromes of the gastrointestinal tract. Category: Other research. Records: American Journal of Clinical Pathology 28(2), Aug 1957 p. 115-

Page 25

Studv #NNMC-08: The Use of Radioisotopes in Diagnostic Hematologic Procedures, Fe-59 Erythrokinetic Studies. Purpose: To evaluate diseases of the hematopoietic system using labeled plasma with radioactive iron, and then determining the rate of disappearance of Fe-59 from the plasma, its incorporation into red blood cells, and its localization in selected sites in the body. Records: American Journal of Clinical Pathology 28(2), Aug 1957, p.

Page 26

Studv #NNMC-09: The Use of Radioisotopes in Diagnostic Hematologic Purpose: To evaluate the counting of Cr-51 and Fe-59 simultaneously using gamma-ray spectrometry for determining red blood cell volume , survival time of circulating erythrocytes, plasma iron turnover and utilization of iron by red blood cells for evaluation of diseases of the Category: Other research. Records: American Journal of Clinical Pathology 28(5), Nov. 57, p. 469-

Page 27

Studv #NNMC-10: Blood Volume Studies in Thoracic Surgical Patients Using Radioactive Iodinated Human Serum Albumin Location: Naval Hospital (Tom Mitchil, stationed at NNMC was invited to participate in this study.) Purpose: To evaluate blood volume changes in excisional pulmonary surgical patients using Iodinated human serum albumin. Category: Other research. Records: Journal of Thoracic Surgery (Saint Louis) 30(5), Nov. 1955,

Page 28

Studv #NNMC-11: Studies of the Localization of Radioactive Gallium, GA-72, in Bone Lesions Purpose: Study of the ability of Gallium-72 (versus gallium-69) to localize malignant lesions and non-malignant lesions involving bone. Procedures and results are presented. Records: Journal Bone Surgery American, Vol. 38-A(3), June 56, pages

Page 29

Studv #NNMC-12: Pancreatic Exocrine Function: A Simplified Test Using Radioactive Fat Excretion Subjects: Approximately 21 males and females ranging in age from 11 to 70 Purpose: Development and evaluation of a nuclear medicine test to evaluate pancreatic function. Category: Other research. Records: American Journal of Digestive Disease, Vol2, No. 12,1957

Page 30

Studv #NNMC-13: A Study of Methods for Interstitial Implantation of Subjects: NONE, THE SUBJECTS WERE RABBITS

Page 31

Studv #NNMC-l4: Late Follow-Up Studies After Internal Deposition of Purpose: Long term follow-up of 35 patients that had been administered thorotrast approximately 35 years earlier. Pilot study recommending large scale nation wide study. Category: Therapeutic research. Records: Journal of the American Medical Association, 160(1), 7

Page 32

Studv #NNMC-15: The Excretion of Thorium and Thorium Daughters After Thorotrast Administration Subjects: Two terminal cancer …