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Part II

Chapter 8


What is TBI?

Early Use of TBI for Radioresistant Tumors: The Manhattan Project Experiments on Patients and the Subsequent AEC Review

Renewed Interest in Total-Body Irradiation

Postwar TBI-Effects Experimentation: Continued Reliance on Sick Patients in Place of Healthy "Normals"

AEC-Sponsored TBI at Oak Ridge


Chapter 8: AEC-Sponsored TBI at Oak Ridge

At the same time that the University of Cincinnati was conducting TBI experiments for the DOD, the Medical Division of the AEC’s Oak Ridge Institute of Nuclear Studies (ORINS)[171] was also treating patients with selected tumors with TBI; retrospective and prospective analyses of these data were supported by the National Aeronautics and Space Administration.[172] ORINS was established in the late 1940s as a research institution to help advance the field of nuclear medicine through research, training, and technology development.[173] From 1957 to 1974, the ORINS/ORAU hospital treated 194 patients with TBI. In contrast with the DOD-sponsored experiments at Cincinnati and the other institutions, ORINS/ORAU used TBI only to treat patients with radiosensitive cancers.

Indeed, in 1972, the ORAU Medical Program Review Committee issued a report on the ORAU TBI activities in light of the recent revelations about the University of Cincinnati TBI program, noting that the studies were ethically conducted and that survival rates were as good as with other methods of treatment.[174]

Nonetheless, similar questions have been raised about the dual-purpose nature of the Oak Ridge program. As happened at Cincinnati, the Oak Ridge TBI experiments, although known in the national and international medical and scientific communities through presentations and publications, first came to the attention of the general public through the news media. In September 1981, Mother Jones magazine published an article charging that ORINS/ORAU treated its patients with total-body irradiation in order to collect data for NASA.[175] The article focused on one patient in particular--Dwayne Sexton, who suffered from acute lymphocytic leukemia and was treated with TBI and chemotherapy over the course of three years until he died in 1968. That article prompted an investigation and public hearing by the Investigations and Oversight Subcommittee of the House Science and Technology Committee, which was chaired by Representative Albert Gore.[176] Testifying before the subcommittee were patients and patient relatives; administrative officials from Oak Ridge, the AEC, and NASA; the medical staff of ORAU; and two cancer experts: Dr. Peter Wiernik, director of the Baltimore Cancer Research Center, and Dr. Eli Glatstein, who was then chief of radiation oncology at the National Cancer Institute and is now a member of the Advisory Committee on Human Radiation Experiments.

ORINS began treating patients with TBI in 1957. Following a 1958 accident at the Oak Ridge Y-12 production plant, in which eight workers were irradiated and treated by the ORINS hospital, ORINS took a heightened interest in the use and effects of TBI. As William R. Bibb, then director of the Department of Energy’s Research Division at Oak Ridge, testified at the Gore Hearing: "In order to provide the best possible care in case of an accident the AEC expected that hematologic data from patients being treated with total body irradiation in addition to being used to benefit other patients would also be used to benefit any radiation accident victim."[177] In 1960, the ORINS hospital completed a newly designed irradiation facility that could deliver a uniform dose to all portions of the body without having to move the patient, known as the Medium Exposure Total Body Irradiator (METBI). The METBI facility delivered approximately 1.5 rad per minute. Several years later, ORINS sought to test the hypothesis that exposure to low doses of radiation over an extended period of time would be more effective than a single administration of a similar total radiation dose to the whole body in treating certain types of diffuse tumors known to be responsive to radiation. Accordingly, it developed the Low Exposure Total Body Irradiator (LETBI) as a "one of a kind" system to test this hypothesis. LETBI, which could deliver a whole-body radiation dose of 1.5 rad per hour, went into operation in 1967 and patients could spend several days or weeks in this facility. AEC sponsored all activities concerned with the construction and operation of the LETBI and its use in patient treatment. The results of this treatment approach, however, were found to be no better than others then available, and the use of the LETBI was discontinued in the early 1970s.

The LETBI project was conceived at approximately the same time that NASA had commissioned ORINS to study the effects of total-body irradiation. NASA was particularly interested in the effects of low dose-rate radiation that the LETBI would produce because astronauts would most likely be exposed to low-dose cosmic radiation. Accordingly, NASA provided approximately $65,000 to the AEC for monitoring equipment and the radiation sources used for the LETBI.[178] At the Gore Hearing, officials from the AEC and NASA testified that the LETBI program was conceived purely for therapeutic purposes and that NASA's interest in the data from LETBI exposures in no way influenced the decision to construct the facility or its use for patients. Dr. Clarence Lushbaugh, who ran the LETBI facility under Dr. Gould Andrews, and succeeded Andrews as director of the ORAU medical division, testified: "First, neither NASA nor AEC program monitors, to my knowledge, ever attempted to become involved directly or indirectly with the treatment of patients at the ORINS/ORAU Medical Division. Second, the ORINS/ORAU NASA study group never influenced the clinicians in their selection of patients or the prescription of the exposure dose and dose rates."[179]

There was little dispute with the view of the 1972 Medical Program Review Committee, expressed above, that, at least in the early years, TBI was a legitimate form of treatment worth exploring for the radiosensitive cancers that ORINS/ORAU was treating. The Review Committee's concern was whether the Oak Ridge medical staff conducted their investigations in an effective manner and whether the AEC's or NASA's interest in the data compelled the continuation of this modality at a time when other forms of treatment were considered more effective. Dr. Peter H. Wiernik, one of the two expert witnesses, acknowledged, for example, that in the early years it was legitimate to experiment with TBI at the high doses being used to try to improve treatment, because "clearly treatment needed to be advanced in those days."[180]

The record of the 1972 review suggests that the ORINS/ORAU staff did not engage in the type of rigorous, systematic research that would be necessary to evaluate the usefulness of that type of therapy. The Oak Ridge doctors acknowledged that they were not evaluating the long-term effectiveness of single-exposure, high-dose TBI and that fractionated exposures (in which numerous smaller doses are given over a period of several weeks or months) "probably offers a preferable approach for total-body irradiation therapy."[181] Dr. Lushbaugh explained that, because the doctors would administer whatever treatment they thought was "best for each patient," they did not adhere to an established research protocol based exclusively on TBI.[182]

In commenting on the 1972 report before the Gore Committee, Dr. Glatstein questioned the "manner of administration and the uncontrolled nature of the studies." Oncology research, he said, requires "an obsession with time"--the effect that a given treatment has over months or years. Glatstein noted that the reports he reviewed "are interesting in terms of acute radiation effects but really don't have any substance in terms of oncologic practice."[183] Glatstein summarized his view of the ORINS/ORAU TBI research program: "If you are talking about the early 60's I think this is probably fairly representative of protocols that were going on at that time. . . . [B]y the end of that decade I believe this was probably not acceptable."[184]

Both Wiernik and Glatstein criticized Dwayne Sexton's medical (nonradiation) treatment, in particular the decision to withhold maintenance chemotherapy, which was recognized as an effective treatment at that time, in order to attempt a never-before-used experimental procedure.[185]something new and innovative had to be tried to try to improve the survival rate of acute leukemia in children." Comments to the file prepared by Helen Vodopick, M.D., following the Gore Hearing, 6. Even if the new treatment was worth pursuing, they argued, it should have been done only as part of a larger protocol and only when the patient was in secondary remission following the failure of more-effective treatments.

All patients accepted into the ORINS/ORAU hospital program signed a "Patient Admittance Agreement" that explained that the hospital operated for the purpose of conducting radiation-related research. The form stated that the patient is being admitted because his physical condition "makes me a suitable patient for a currently active clinical research project," that experimental examinations, treatments, and tests may be prescribed for which the patient hereby gives his or her consent, and that the patient "can remain in the research hospital only so long as I am needed for research purposes." Additional forms were used to establish "Consent for Experimental Treatment," which stated that "the nature and purpose of the treatment, possible alternative methods of treatment, the risks involved, and the possibilities of complications have been explained to me. I understand that this treatment is not the usual treatment for my disorder and is therefore experimental and remains unproven by medical experience so that the consequences may be unpredictable."[186] The form made no mention of the possible risk of death from bone marrow suppression or specific side effects such as nausea or vomiting.

In 1974, the AEC conducted a program review of the Medical Division of ORAU. It recommended that the clinical TBI programs be closed, having found that the METBI and LETBI programs had "evolved without adequate planning, criticism or objectives, and have achieved less in substantial productivity than merits continued support."[187]

At the end of his hearing, Gore noted that the subcommittee would issue a report with conclusions and recommendations. Although no formal report was ever completed, the full committee issued the following statement in January 1983: "The Subcommittee testimony revealed that while many of the conditions at [ORAU] were not satisfactory, particularly when judged by the routine institutional safeguards and medical knowledge of today, the more scandalous allegations could not be substantiated. Given the standards of informed consent at the time, and the state of nuclear medicine, the experiments were satisfactory, but not perfect."[188]

Perhaps the most striking contrast between philosophies of the Oak Ridge and the University of Cincinnati TBI programs can be gleaned from an exchange that occurred in 1966. That year, the AEC’s Medical Program Review Committee suggested that ORAU consider using TBI for treatment of radioresistant cancers (similar to what was being done at Cincinnati).[189] The ORAU physicians responded that they had carefully considered treating such diseases, but had declined to do so:

[W]e are very hesitant to treat them because we believe there is so little chance of benefit to make it questionable ethically to treat them. Lesions that require moderate or high doses of local therapy for benefit, or that are actually resistant (gastroenteric tract) are not helped enough by total body radiation to justify the bone marrow depression that is induced. Of course, in one way these patients would make good subjects for research because their hematologic responses are more nearly like those of normals than are the responses of patients with hematologic disorders.[190]
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