The Plutonium Files (57 page)

The Cincinnati doctors were aware of the life-threatening dangers of TBI, the military reports reveal. Only one year into the study, Saenger and colleague Benjamin Friedman hypothesized that sick patients may be “unusually susceptible” to radiation. “We have had two cases, one at 150 and one at 200 rad, expire while manifesting the hematologic abnormalities of group III of the acute radiation syndrome,” they remarked in their 1962 paper to the Defense Atomic Support Agency.
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A progress report summarizing the first five years of the experiment noted that “severe hematologic depression was found in most patients who expired.”
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In the same report, the doctors observed, “Several of the patients have had the manifest illness stage of the acute radiation syndrome.…
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Ten of the patients died within thirty-seven days following treatment.” For the report period ending April 30, 1967, the doctors wrote that “marked hematological depression occurred in all eighteen patients who received more than 125 rad total body radiation.”
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And finally, in 1969 the Cincinnati group remarked that under one classification system used to describe radiation injury, four of eleven patients who received
200 rads of TBI “would have been classified as having sustained ‘very severe’ injury; three ‘severely’ injured and five only ‘moderately’ injured.”
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Saenger and his colleagues in the early to mid-1960s began to prepare facilities that would allow them to do autologous bone marrow transplants, a procedure in which some of the patient’s bone marrow is withdrawn before the irradiation and returned to the body after the treatment is done. The Cincinnati doctors hoped the procedure would prolong the lives of patients whose bone marrow was severely damaged by the radiation exposures they were administering.

Five years were to pass before the doctors succeeded in performing their first successful bone marrow transplant. In the meantime, they continued to administer high doses of total-body irradiation and partial-body irradiation to numerous patients without the supporting bone marrow transplants. In 1969, just two years before the program was terminated, the physicians admitted, “In view of the life threatening hematologic abnormalities we have encountered in patients receiving 150–200 rad (226 to 336R) total body radiation, marrow storage is felt to be mandatory.”y

At the time, the process of withdrawing the marrow and reinfusing it back into the patients was itself extremely risky. The subjects were placed under general anesthesia for one and a half to two hours while about a pint of marrow was aspirated from sites in the hips and sternum. The marrow was put into storage and then infused back into the patients’ veins after the TBI treatment. From there the marrow traveled through the bloodstream to the red bone marrow cavities, where it produced new cells.

According to Defense Department or university records, thirteen patients received bone marrow transplants. Margaret Bacon, an eighty-year-old woman who had been diagnosed with bladder cancer and did not want radical intervention, suffered a stroke when she was anesthetized for the bone marrow removal procedure on June 4, 1969. The doctors, apparently unaware of the stroke, proceeded to give her 150 rads total-body irradiation the same day and she died six days later.
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The informed consent procedures went through a series of changes over the eleven years of the project. Between 1960 and 1964, the hospital’s general consent form for all medical and surgical procedures was used. Members of Saenger’s team said the patients were verbally informed of
the nature of the experiment and asked for their agreement to participate in the project.
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The first written consent form for the TBI treatment came into use in 1965. The document contains no specifics on what exactly the patients were told: “The nature and purpose of this therapy, possible alternative methods of treatment, the risks involved, the possibility of complications and prognosis have been fully explained to me.
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The special study and research nature of this treatment has been discussed with me and understood by me.”

The doctors submitted the bone marrow portion of the project in 1966 to the Faculty Committee on Research, which had been created the previous year to oversee human experimentation at the medical center. “This work,” physician-investigator Benjamin Friedman explained to the Faculty Committee, “is considered to be of vital importance not only for improving the survival of patients with far advanced cancer but for the survival of the citizens of this nation in the event of nuclear warfare or a major peacetime radiation accident.”
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Its “vital importance” notwithstanding, the project’s protocol drew harsh criticism from several university reviewers. One doctor, George Shields, withdrew from the subcommittee studying the proposal because of close professional and personal ties with the investigators. In his withdrawal notice, Shields recommended the study be disapproved because of the high risks. “The radiation proposed has been documented in the author’s own series to cause a 25 percent mortality,” he said.
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The consent forms, he advised, should also contain a statement that “a 1 in 4 chance of death within a few weeks due to treatment, exists, etc.” He added:

Another member of the review committee, Thomas Gaffney, also questioned the wisdom of expanding the TBI study given its “consider
able morbidity.”
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Gaffney was also highly critical of the study design and predicted that the experiment would not yield meaningful data:

Despite the reviewers’ reservations, the experiment was allowed to proceed. Another thirty to thirty-five patients were irradiated before the experiment became public and was terminated four years later. Edward Radford, one of the faculty members who sat on the review committee, recalled that the panel was a little intimidated by Saenger. “We hadn’t thought through the whole moral morass quite as thoroughly as people have now,” he told a reporter.
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“And Dr. Saenger was irate. He said, Who are these guys telling me how to do my research?’ He was still living in the period when the doctor was God.”

The consent forms underwent two more revisions. In a 1967 form, the patients were informed that the experiment might not benefit them but could advance medical knowledge “which may result for the benefit of mankind.”
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They also were informed that the risks of TBI included the “chance of infection or mild bleeding to be treated with marrow transplant, drugs, or transfusion as needed.”

The third and final consent form, which came into use in 1971, went into greater detail but still did not disclose that the patient might die from the procedure: “…   if you receive a dose of 200 rads or more, which your doctor will tell you, your blood counts will fall to levels where infection or bleeding could be a problem.
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The bleeding can be treated by transfusion of red cells and platelets and the infection by antibiotics. In addition, we prevent such low blood counts with the use of a bone marrow transplant which will be discussed with you in a separate voluntary consent statement.…” In the later years Saenger and his
coresearchers said they began a two-day consent process. The TBI treatment was explained to the patient during the first day. The consent form was signed on the following day after the patient talked the matter over with his or her family.

The military’s oversight of the experiment was virtually nil. Occasionally military representatives would visit Cincinnati and Saenger would show them around, but no specific suggestions regarding the research were offered. During the last six years of the experiment, Saenger was a consultant to a medical advisory committee established by the Defense Atomic Support Agency, the very organization that was funding his project.
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In 1969 the National Institutes of Health declined to fund the experiment on “ethical grounds.” The NIH again declined to fund the experiment in 1973. Despite the rejections, Donald Chalkley, described in press reports as the NIH’s “ethics watchdog,” later praised the Cincinnati experiment, noting that it had promised to be “a significant addition to our armamentarium against metastatic cancer.”
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Woodrow Wilson Litton felt perfectly healthy when he was admitted for the first time to the small research hospital in Oak Ridge, Tennessee.
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His dark eyes and black hair gleamed with vitality and he had the loose, graceful frame of an athlete. He was forty-one years old, a materials dispatcher at one of the uranium production plants, and had missed only three days of work over the past ten years. During a routine physical in the spring of 1961, a plant doctor had discovered that Litton had several swollen lymph nodes in his neck and groin area. The nodes were about the size of peas and not at all painful. Litton had noticed them, too, but wrote them off as harmless. The doctor was concerned, though, and referred him to an Oak Ridge physician, who removed one of the nodes. The physician’s findings came as a shock: Litton, he concluded, had lymphoma, or cancer of the lymph system.

Litton was then referred to the Medical Division Hospital run by the Oak Ridge Institute of Nuclear Studies, frequently referred to as ORINS. The hospital was one of the three cancer research facilities established by Shields Warren in the late 1940s and was originally assigned space in a wing of the former Manhattan Engineer District hospital where Ebb Cade had been injected with plutonium. Eventually the ORINS hospital, related laboratories, and treatment rooms occupied the entire building. The patients were required to sign various papers prior to admittance. The forms disclosed that the treatments were experimental and held no definite promise of benefit or cure, but they did not reveal the possibility that procedures might increase the patients’ pain or hasten their deaths.

One of the first doctors to examine Woodrow Wilson Litton was Herbert Gerstner, the Paperclip specialist from the School of Aviation Medicine, who had gone to ORINS to get his medical license and worked briefly at the Oak Ridge hospital. Gerstner listened to the slow thump of Litton’s heart, the clear, unobstructed breathing, and then questioned him about his family’s medical history. Litton was the nineteenth child in a family of twenty-one children. There was no history of cancer or unusual childhood diseases. “Physical examination reveals a well-developed white male who is very alert and cooperative,” Gerstner remarked.
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Thinking perhaps of his research in Germany, he added that Litton “hears perfectly well.”

Litton underwent a series of diagnostic tests over the next two days. “The findings,” Gerstner wrote, “were not sufficient to establish the diagnosis of malignant lymphoma with absolute certainty.” Litton was discharged, but was to return to the hospital many times over the next four years. Gerstner’s name does not show up again in his medical records.

Litton’s diagnosis was difficult to verify. ORINS pathologists disagreed among themselves about whether his lymph cells were truly cancerous and decided to do another node biopsy. Some of the biopsy material was forwarded to consultants at the University of Cincinnati and the University of Chicago. Two consultants said it was lymphoma; two said it wasn’t. One of the Chicago physicians said that she had seen nodes such as Litton’s stabilize or regress and that active treatment wasn’t necessarily required.

Litton, meanwhile, was seen regularly at the research hospital by a doctor named D. A. White. He had no complaints. He was eating, sleeping, and working hard. On one occasion, he said he had an odd sensation “like water slipping through a vessel” on his left lower leg. Almost a year to the day after the discovery of the cancer, lab reports showed an increase in his white blood cells. Although Litton felt fine, ORINS doctors decided to give him fifty roentgens of total-body irradiation in a state-of-the-art chamber called the Medium Exposure Rate Total Body Irradiator, or METBI, which had been in operation since 1960. His physician, D. A. White, wrote on May 1, 1962, “Mr. Litton seemed quite pleased when I suggested that I thought it would be well to arrange for him to have total-body irradiation in the near future.”
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