Orins/Orau Total Body Irradiation - Program Correspondence, Articles 1981, 1982

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Oak Ridge Associated Universities Post Office Eox 117 Oak Ridge, Tennessee 37830 I became greatly disturbed when I heard of the malignant article preciate having you send me the reprint. sign concept of the nedical experiment. A s you a r e aware, Andy’s original interest was the effect of low dose whole body radiation. There isa body of infomation concerning the effects of low dose radiation which is certainly well documented i n the older literature and has been present f o r many many years. I have used i t myself with k’ayne Rundles a t Duke on occasion using orthovoltage radiation. The experience a t Hernorial i n the early days using the Heublin room was, o f course, another attempt and there are many others. Andy’s initial interest though was i n the radiobiologic effects of extremely low dose radiatlon a s the capability. to.do this had not been previously present and by the use o f the facilities at Oak Ridge and utilizing a rtl fic ally produced radioactive sources, both cesium and cobalt,a variety of dose rates could be developed. Hi dose total and partial body radiation has been widely used and there i s even now a resurgence of interest in this where I acted as a consultant and actually advised on the dose rate to be used. Unfortunately, my files on this work were destroyed and I do not have the information available, butI ’ m sure the files at Oak Ridge would contain this information. the effects of space radlatlon. I t just so happened that the General Electric facility here i n Daytona was interested In this aspect a s well andI became a consultant to MSA in this regard and had a number of I finally found a copy o f the article but I apAs I related to you, I was involved with Andy i n the original deI do remember a number of conferences held a t Oak Ridge Later NASA became involved simply because they were interested i n

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conversations with their investigators, a s well as a visit to their space radiation laboratory in King of Prussia, Pennsylvania. Fere interested in possible effects of space radiation on manned space vehicles and,of course, you further developed data in this area. I can assure you tfiat there was never any interest in the use o f human patients that was directed t o other than medical biological rcsul ts, and the information obtained on radiation effects that iiASA was i n - terested i n was certainly a serendipitous side effect.I, of course, realize that they later supported and funded some-of the program. tiy greatest concern i s the fact that Gould Andrcws' expertise and reputation i s being threatened in this instance. Those of us who knew and worked with Gould know that he was not only a riedtcal scientist of highest caliber,but was also one of the most cornpassionate physicians thatI know and was a n authority on oncology as patients, particularly the Sexton child,and the inpl ications that patients were uninfonried of experimental therapy, is entirely fa1 - lacious. During allof my associations with Oak Ridge, the pztientr and their faniil ies v:ere inforined specifically of the experimental nature o f treatment and the patients were selected after group conferences a n d were patients where standard currefit accepted therapy had failed or was not indicated. review, or inadequate peer review, are sirtiply erroneous. There was reer review with cotmiittees frorr! all of the universities that supported the entire pmgrani as you vie11 know. This Fas not o f the same intensity that presently exists in the KI,but they wcre present. The present criticisms of the use of certain I n addition, the allegations of no peer tive reporting" with the objective t o provide sensation and distort facts and conditions rather than expose' m i management or incompetency. I think the article in "Science" which relates remarks of a number of current prominent oncologists were rather mixed, but in cjeneral confirm that standard therapy, atleast for the Sexton child, was utilized and that the experimental aspects o f treatment were, a1 though unusual by today's standards, were certainly provocative and well worth investigating. I n some instances I believe their statements were out of context and they probably were unaware of the total program or the specifics of the individual case. I n any event, I certainly wish t o convey t o you that if there i s anything at all that I can doto aid in this matter, please do not hesitate to let ne know.

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SCIEKCE Vol. 2 1 3 , No. 4 5 1 2 September 4 , 1981 p . 1093 Human Guinea Pigs at Oak Ridge? Scientists respond to a report that they used cancer patients to test man's tolerance of radiation in space The investigations subcommittee of the House Committee on Science and Technology is planning to hold hearings later this month on a report that got a lot of attention on 20 August: a charge that during the 1960's cancer patients at a small clinic linked with the Oak Ridge National Laboratory in Tennessee may have received unnecessary doses of gamma rays in an experiment aimed at learning just how much radiation astronauts could tolerate before becoming sick and choking in their oxygen masks. The hearings will be chaired by a Tennessean. Representative Albert Gore, Jr. Oak Ridge officials were caught somewhat unprepared when the author and publisher of the report, Howard Roseninterviewing officials, and reading The 20 August press conference made a splash on the national evening news. Among those who spoke before the cameras were Mary Sue Sexton, distraught nessean who died at the hospital in 1968; Karl Morgan, former chief health physicist at Oak Ridge, who said he felt "sorrow and dismay" that he had once sent a friend to the Oak Ridge clinic; and Peter Wiernick. a physician from the Baltimore Cancer Center, who said that he thought the clinic made a mistake in not telling patients about the uses to be made of the radiation research. He also thought the Sexton child might not have Rosenberg claimed that the cancer program was "corrupted" by the desire to find data for NASA, and that patients were given nontherapeutic doses of radiation. berg and Mother Jones magazine, held a press conference before network television cameras in Washington, D.C. A spokesman for the medical division at Oak Ridge, Wayne Range, essentially denied the thrust of the article, but challenged few of the facts. (The hospital itself has been closed since 1974.) Although the National Aeronautics and Space Administration (NASA) did pay for some of the research, Range said. its involvement was passive. Cancer therapy given at the hospital, he claimed, (vas a standard variety for 1965. and all that NASA gained was an opponunity to examine some patients' records. Rosenberg's report focused on the case of Dwayne Sexton, a child with acute leukemia who was treated at the Oak Ridge Institute of Nuclear Studies between 1965 and 1968. The author explained that Sexton was the only one of atically exposed to large doses of radiation between 1960 and 1974 in two specially designed chambers" whose record he was able to reconstruct. Rosenberg said he had spent 18 months canvassing Tennessee for information on patients, received normal care in that he was not given a standard course of chemotherapy before other, untesfed therapies were According to Rosenberg, doctors at the Oak Ridge Institute of Nuclear Studies who treated Sexton between 1%5 and 1968 "belatedly began treating Dwayne Sexton with chemotherapy" only after they tried and failed to help him with an unusual experiment in immunology. Rosenberg also stressed that Sexton was later given a large dose of total-body radiation and sent to recover in a radiation chamber (not in operation) used to treat other patients. Beneath the chamber was an area where animals were kept. When the room was in use. they were exposed to gamma rays along with patients. Rosenberg suggsred that pcople like Sexton, highly susceptible to infection, could have been exposed to dangerous bacteria. Sexton did. in fact. die of strep and staph infections, a common pattern for acute leukemia patients. Oak Ridge officials insist that bacteria from animals were not a problem. since the chamber was the cleanest area in the hospital, ,and no animals were present until 1969. the year after Sexton's death. The animals had a separate air supply system. Cages and debris were moved through hallways where patients walked. but laboratory officials say there was no risk of contamination because the trash was kept- in airtight plastic bags. Rosenberg released other documents. including the summary of an unfavorable review given the clinic by the parent . agency, the old Atomic Encrgy Commission (AEC), in 1974. According to the AEC summary, the clinic's facilities censing and accreditation guidelines," the entire medical division was "essentially isolated from the critical climate of academic clinical investigation." the main laboratories were inadequate, and the hematology program was particularly deficient. The irradiation programs were ning, criticism, or objectives." The bone marrow immunology program was cited questions were raised with respect to the In addition, Rosenberg cited the fact that NASA financed some of the clinic's equipment and paid the salaries of some researchers. He claimed that the cancer program was "corrupted" by the desire to find data for NASA, and that patients were given nontherapeutic doses of radiA team led by Oak Ridge pathologist Clarence Lushbaugh, now chairman of Oak Ridge's entire medical division. was recruited to study the nausea-inducing effects of radiation. Lushbaugh analyzed the records of 3000 patients in 46 hospitals to learn about the dangers that would confront the astronauts. Oak Ridge was not the primary source of Lushbaugh's information, for it gave radiotherapy to no more than 186 patients. The man who was then chairman of er of the treatment protocols, Gould Andrews, died in 1980. Speaking in his place. Lushbaugh now claims that Andrews made all decisions on therapy and was in no way influenced by NASA's concerns. Karl Hubner, a member of the hematology staff. said that the therapy offered at Oak Ridge in the 1 9 6 0 ' s and early 1970's was perfectly in keeping with standard approaches of the day.

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in Manned Spacejighi. published by the National Academy of Sciences in 1967. Nevertheless. he conceded that Oak Ridge did perform some NASA-financed prospective studies with cancer patients between 1%9 and 1974. The purpose, he said. was to use the new monitoring system to- try to find physiological signals indicating that a patient was about to become nauseous before the patient sensed nausea himself. No warning signals were found. Although the research was funded by NASA. Bibb insisted that the space agency had no influence over Hubner specifically denied the charge that Dwayne Sexton was given improper treatment. According to the medical records. Hfibner said. the doctors first extracted a sample of bone marrow from the child in July 1965. Then they immediately started him on a course of chemotherapy lasting 17 days. The chemotherapy was stopped while they attempted an immunologic experiment. They irradiated the child's leukemic manow cells, injected them into his mother, and then reinjected fluid from the mother back into the boy. The hope was that the mother would produce antibodies to kemia was judged to be in remission. probably as a result of the first dose of chemotherapy. For IS weeks the child received no chemotherapy. Then the disease r essene d itself. proving that the immunologic experiment had failed. The child was given chemotherapy again. tine was repeated for five more cycles, Then the physicians decided that the drugs were failing. On 3 December 1968. the child was given his first and only radiation: a whole-body dose of 353 roentgens (or 265 rads) over a period of 3 hours and 38 minutes. The hospital record states: "Definite relapse from the decided to try to induct another remisThe patient received 353 roentgens of no adverse effects during the time of the irradiation and amazingly did not have any nausea nor vomiting during the time of exposure or immediately thereafter. The patient was then kept in as sterile an quite apparent that the leukemic process was still not under control." He began to bleed internally and developed infections which could not be controlled by antibiotics. On 29 December. a little more rhan three weeks after trradiation. he died. Radiologists at Harvard's Joint Center Range said. "We are quite proud of our record. .\I a time when patienis with acute leukemia had a survival outlook of about 6 months to a year. our patients were surviving on the avenge something like 4.5 years." n e record compares well with those of other clinical centers in the 1960's. Range said. William Bibb. the former AEC official in charge of funding the program. said that the Oak Ridge clinic was opened in 1950 "to take advantage of some of the rechnology coming out of the atomic energy business before it was ~ ene rally available." The clinic was closed in 1974 for two reasons: other centers nearby wirh broader skills were giving comparable medical care, and the meager research output from Oak Ridge no longer justified the cost. Bibb said that in the final years. the clinic had only about seven patients at any given time. Bibb described NASA's involvement as minimal. NASA came to him in the early 1960's because it was worried about 'the possible effects of solar flares, encounters with the Van Allen belt, and other radiation hazards in space. I n 1961. 14 years after the Oak Ridge clinic had opened, the AEC agreed to run a rerrospective study to collect the data NASA wanted from its own records and from other places. Later on, Bibb said, NASA agreed that in addition to paying the salaries of those doing the paper analysis. it would also provide some state-ofthe-an monitoring equipment to record changes in the vital signs of patients undergoing whole-body irradiation at Oak Ridge. Patients sometimes stayed 3 days in the specially designed wholebody irradiation room. a chamber suspended in a concrete cell and flooded with gamma radiation at a level of about 1.6 roentgens' per hour. With the aid of tor a patient's pulse and temperature without entering the room. She data were examined by the physicians and SASA also paid for a computer to help . son through the voluminous files. .'It would have been as stupid as hell." Bibb said. for NASA to try to get significant data from the Oak Ridge clinic alone. because it treated only 186 parients. Any conclusion based on data. he said. "wouidn't have been wonh the paper it was written on because there wouldn't be enough data points to mean Bibb pointed out that much oi the ed in the book. Raciiooioiogicol Focrors for Radiotherapy, at the National Cancer …