Letter to J S Herrington, Subject: Investigation Into Radiation Experimentation for Human Subjects

Page 1

U.S. HOUSE OF REPRESENTATIVES SUBCOMMITTEE ON ENERGY CONSERVATION COMMITTEE ON ENERGY AND COMMERCF . - The Honorable John S. Herrington Department of Energy 1000 Independence Avenue, SOW, Dear Secretary Herrington: Power has been conducting an investigation into radiation experimentation for human subjects, results of that investigation,a Subcommittee staff report titled, .American Nuclear Guinea Pigs : Three Decades of Radiation revealed the frequent and systematic use of human subjects as guinea pigs for radiation experiments sponsored by the Department ' 8predecessor agencies, Some of these experiments were conducted inthe1940s and 19506, and others were performed during the supposedly more enlightened 1960s and 19708, describes in detail 31 experiments during which about 695 persons As you know, the Subcommittee on Energy Conservation and -- I am forwarding t o you the This report reviewed Department of Energy documents, which I n many of these experiments, individuals were exposed t o - radiation which provided little or no medical benefit to the subjects, The purpose of several of these experiments was actually to cause injury to the participants, Many others sought simply to measure the effects of radiation on humans, American citizens thu6 became nuclear calibration devices for experimenter6 Ina number of experiments, eu bj ect s received doses that exceeded presently recognized limits for occupational radiation exposure, Doses were a6 much as 9 8 times t h e body burden recognized at the time the experiments were conducted, captfve audiences or populations that ~ o m eexperimentere frighteningly perhaps might have coneidercd Dcxpendablcr* the elderly,prisoners,hospital patients suffering from terminal diseases or who might not bwe retained their full faculties for Too many of these experiment6 used human subjects that were

Page 2

The Eonorable John SI Ber ring ton include the fol loving : 6omc of t h e more repugnant or bizarre of these experiments ,> -Prom 1945 t o 1917, as part of the Manhattan Project, 18 - patients believed to have limited lifespans were injected vith --Prom 1961 t o 1965, a t the PiaSSaChUSett6 Institute of Technology, 20 elderly subjects were injected or fed radium or -During 1946 and 1947, at the University of Rochester, six patients with good kidney function were injected with uranium salts to determine the concentration which vould produce renal Boston# approximately 12 terminal brain tumor patients were injected with uranium to determine - the dose a t which kidney damage --Prom 1963 t o 1971, 67 inmates a t Oregon State Prison and 64 inmates a t Washington State prison received x-rays to their testes t o examine the effects of radiation on human fertility and --Prom 1963 t o 1965, at the Atomic Energy Commission's National Reactor Testing Station in Idaho, radioactive iodine was purposely released o n seven separate occasions. I n one experiment, seven human subjects drank milk from cows which had -Prom 1961to 1963, a t the University of Chicago and Argonne National Laboratory,102 human subjects were fed real fallout from the Nevada Test Site; simulated fallout particles containing radios ct ive material; or solutions of radioactive cesium and -During the late19506, at Columbia University and Xontcf i or c Hospital,the Bronx, 12 terminal cancer patients were injected vith r sdio active calcium and strontium. These experiments, and Other6 described Inthe Subcommittee 8taff report, shock the conscience and represent a black mark on the history of nuclear medical research, They raise one major horrifying question : did the intense desire t o know the consequences of radioactive exposure after the dawn of the atomic age lead American scientists to mimic the kind of demented human experiments conducted by the Baz is ? Did the Department or its

Page 3

The Honorable John S. Herrington predecessor agencies fund or sponsor programs which crossed the line that no scientific research can evec be permitted t o While it is clear that present public and scientific officials are generally not responsible for these experiments, these circumstances nonetheless represent a historical, i n ~ t it uti on a lf a i lure. To compound the evil,in too many experiments, no l o n g term follow up was conducted of subjects. While these experiments cannot be undone, though they must never be repeated, there are potential remedial steps that can be taken to help the victims who served as human nuclear guinea pigs. I therefore urge the Department of Energy to make every practicable effort to identify the persons who served as experimental subjects, t o examine the long term histories of subjects for an increased incidence of radiation - associated diseases, and t o cornpens3te these unfortunate victims for for such follow up. The Nuclear Test Personnel Review, administered by the Defense Nuclear Agency, is a registry for military personnel exposed to fallout f tom atmospheric nuclear tests, The primary objectives of the Review are to identify the approximately 200,000 Defense Department personnel involved i n 6UCh tests, t o determine their exposures, to identify fncidences of death or illness, and t o assist veterans in claims for A Defense Department program provides a model If such an effort can be carried out for military personnel acting in the line of duty, surely a similar effort should be possible for the far smaller number of peaceful atomic soldiers used as unwitting human subjects in radiation experiments. feel that new legislation would be necessary, the Subcommittee will be pleased t o work with the Department t o develop it. If you have any questions on the material in this letter or the Subcommittee staff report, please contact John Abbotts a? Larry Sidman a t 202-226-2424. I look forward to receiving by November 15, 1986 a description of the Department's plans for long term followup of these experimentally irradiated subjects, and your recommendation for what new legislation,if any, might be

Page 4

o During 1946 and 1347, atthe University of Rochester, 6ix patients with good kidney function were injected with uranium salts t o determine the concentration which would produce renal injury. One patient was diagnosed as being in u ' hallucinatory state, another was considered suffering f rom "emotional mal ad] ust ment, and a third,admitted to the hospital for a fifth time, was described as follows: 'As he had no home, he agreed willingly to enter the metabolic unit for o From 1963 t o 1971, 67 inmates a t Oregon State Prison and 64 inmates atthe Washington State Prison received x-rays to their testes t o examine the effects of ionizing radiation on human fertility and testicular function. These experiments were conducted by t h e Pacific Northwest Research Foundation and the University of Washington, Subjects had t o agree to receive vasectomies after completion of the experiments. The Energy Research a n d Development Administration planned to begin medical followup of the irradiated prisoners,but these plans were dropped i n 1976 at the request of the U.S. Attorney i n Portland after several irradiated inmates filed

Page 5

suits against state and federal governments. (Category 2.001, Number 2 and Category 2.002, o From 1953 t o 1957, u t Massachusetts General Hospital, Boston, approximately 12 terminal brain tumor patients were injected with uranium t o determine the dose at which kidney damage began t o occur. Most of the patients were described as o From 1963 t o 1965, atthe Atomic Energy Commission National Reactor Testing Station in Idaho, radioactive iodine was purposely released on seven separate occasions. I n one of these experiments, seven human subject6 drank milk f tom cows which bad grazed on iodint-contaminated land. This experiment was designed t o measure the passage of iodine through the food chain into the thyroids of the human subjects. Ina second experiment, three human subjects were placed on the pasture during iodine release, and even subjects were placed on the pasture in a third experiment. In addition, .several8 individuals were contaminated during yet another experiment when vials of radioactive in a : - e accidentally

Page 6

for an ulcer. "As h e had no home, he [ Patient 61 agreed willingly to enter the metabolic unit for the largest dose, 7 0 microgram of uranium per kilogram weight, and clinical analysis suggested that " tolerance had been reached" for kidney injury. The summary fact sheet which the Department of Energy submitted to the Subcommittee reports no follow up on the experimental Subjects. Funding for the experiment is not specified, but it presumably would be from the Manhattan Project,since the AEC was not Catesory 2. Testicular Irradiation. Testicular Jr radiation sf Inmates Oreuon State From August 1963 t o May 1971, 67 volunteers at the Oregon State Prison were subjected to testicular irradiation by x-rays. Radiation doses ranged from 0 t o 600 roentgen in single acute exposures, except that six prisoners were irradiated a second time, one a third time, and one w8.s given weekly irradiation s of 5

Page 7

the present occupational limit for exposure t o reproductive organs is5 roentgen per year. These experiments were carried out by the Pacific Northwest Research Foundation, Seattle : the Atomic Energy Commission provided a total of $1.08 million for these The objective of this experiment was to obtain data on the effects of ionizing radiation O A human fertility and the function of testicular cells. It was considered that data from animals could not be readily extrapolated to humans. Studies included examination of testicular tissue, sperm counts, and evaluation of urinary or blood steroids and hormones. Prisoners ranged i n age from 25 t o 52. Each inmate agreed t o have a vasectomy atthe end of his irradiation ; consent of wives was required for this proceaure. All prisoners in the Oregon group did eventually have vasectomies. AT1 volunteers were requf red to sign statements of informed consent. Consent procedures involved an explanation of short term and long term effects, including the possibility of testicular cancer. No Catholics were allowed as subjects. Small sums of money were paid to prisoners: $5 t o $10 for each treatment, and $100 at the time of vasectomy. However, according to the Energy Research and Development Administration 'records suggest that the ? rim - .'- mt iv c to participate may have been the

Page 8

feeling that they were making important contributions to the state of medical knowledge." (ERDA background information on AEC human testicular irradiation projects in Oregon and Washington state prisons, March The prisoner irradiation program was terminated in 1913after the principal investigator suffered an incapacitating stroke, and because of .subsequent stater e-ev alua ti on of cor r ect ional institutional involvement in experimental programs. (COGo Heller e t al., .Protection of the rights and welfare of prison volunteers : Policies followed throughout a 17-year medical research program, unpublished manuscript, p. 7)The same document noted that the vasectomies on subjects after the experiment were necessary " to avoid any possibility of contaminating Ina summary fact6heet provided the Subcommittee in January 1985, the Department of Energy described recovery as shown by a return to pre - irradiated 6perm concentrations and germinal cell number6 was found t o be within 9-18 months for doses of 100 rad and below, 30 months for doses of 200 and 300 rad and 5 or more years for doses of 400 and 600 rad.. The need for folio w up over a longer term was

Page 9

recognized as early as 1973, in a letter from an AEC official to Carl Be ller,the principal Investigator for the experiments, The letter concluded, Thus,I am suggesting that you prepare a protocol for the long-term follow-up of the irradiated volunteers after their release from the research programoo (Frank T. Brooks, Division of Biology and Medicine, AEC, t o Carl G o Heller, Pacific Northwest Research Foundation, Inits 1976 background information material, the .. Energy Research and Development Administration noted: .ERDA believes that there is a need for continued medical surveillance of prisoners involved i n both sets of experiments [Oregon and Washingtonl, and w i l l explore with prison officials the best methods t o achieve this. Among health effects which should be monitored is the possibility of testicular tumors, occurring after a long latency period (25-30 years).’ (ERDA background information, March 1976, pp. 2-3.) However, atthe request of the U.S. Attorney i n Portland, Oregon, this follow up program was cancelled after several irradiated inmates filed suits against state and federal governments. I n September 1976, the District Court for the District of Oregon dismissed the suit against federal defendants. The experiments resulted in the publication of several scientific papers. T! 3 most recent one cited

Page 10

vas M.J. Rowley e t 81, Radiation Research 59, 665-670, Testiculac J r radiation of Jnmates & Washinston State During the period June 1963 t o May 1970, 6 4 inmates at the Washington State Prison received testicular irradiation from x-rays. Each subject was irradiated once, and ddses ranged from 7to 400 roentgen. Following irradiation, tissue samples and sperm were examined for indications of damage; urine 6amples were examined for hormone levels. The Atomic Energy Commission granted $505,000 t o support these studies, which were conducted by University of Washington r ese a t cher 6. The objective of these studies was t o determine the effects of radiation on gonadal function. The 6tu dies were reportedly proposed after a radiation accident at the AEC Hanford facility. Three men were overexposed, and no clear scientific data was .available to advise them on possible sterility effects. The experiments were designed to determine the minimum effective dose that would render an in aiv i dual temporarily sterile. - The criteria for selection were similar to the experiments with Oregon inmates: Participants had t o

Page 11

agree t o vasectomies after completion of the experiment. Bowever, several of the Washington inmates subsequently did not receive vasectomies: 2 declined and were released from prison ; l declined and remained in prison : 1 was released before the scheduled vasectomy; 1did not undergo surgery for psychiatric reasons after mutual agreement with the prison physician; 1 who had heart problems and alife sentence was not vasectomized after mutual agreement. Terminal Report, January 1973, p. 3 ) Because of the lack of follow up information, it is not known i f any experimental subjects subsequently fathered any The experiments were terminated after a Human Subjects review board at the University of Washington refused in July1969to authorize further irradiation Wasnington, to John R. Totter, Director, Division of Biology and Medicine, Atomic Energy Commission, July In the fact sheet submitted to the Subcommittee i n January 1985, the Department of Energy had this description for follow up: "Recovery of cell morphology and function were found after a maximum of 501 days. It wa6 concluded that man is very sensitive i n regard t o temporary sterility, but is very

Page 12

resistant t o complete sterility,. As with the Oregon prisoners,there was no long-term follow up of Several a cie nti fic publications resulted from these experiments, The most recent cited was TOW, Thorslund and C.A. Paulsen, i n Proceedings of the National Symposium on …