ACHRE Report

Part II

Chapter 8

Introduction

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

Conclusion

Chapter 8: Renewed Interest in Total-Body Irradiation

In 1949 AEC and Defense Department planners were seeking information on the human effects of a nuclear reactor-powered airplane. The proponents of the so-called NEPA project,[32] which at the time was managed out of Oak Ridge by the Fairchild Engine and Airplane Corporation on behalf of the Air Force and the AEC, needed to know how much external radiation air crews could tolerate. This question was critical because, depending upon the answer, the shielding needed to separate the crew from the aircraft's nuclear reactor might render the project impractical.

Those involved with the NEPA project were primarily interested in the acute effects of total-body exposure over a relatively short time (although they were also concerned about long-term effects of radiation on longevity and reproduction). It was anticipated that NEPA pilots would be exposed to as much as 25 roentgens in the course of a twenty-four-hour flight. How would this amount of radiation affect the crew's abilities to fly the plane and perform their tactical military function? How many such missions could a crew endure before being incapacitated for flight duty, as well as facing a significant risk of developing a life-shortening disease?

In early 1949, the NEPA Medical Advisory Committee was created to research the questions noted above and to advise on the project. Dr. Andrew Dowdy of UCLA was the chairman.[33] Dr. Robert Stone was chosen to head a human experiment subcommittee. At an April 3, 1949, meeting, Stone proposed to the full committee a program of experimentation using total-body irradiation on healthy subjects. In defense of this proposal, Stone noted that experimentation with normal human subjects had been done in the past when there was no other way to obtain necessary data. At the same time, however, Stone discounted the value of the TBI research that had been performed on sick patients.[34] As Brigadier General James P. Cooney, representing the AEC's Division of Military Applications, put it, "We have lots of cases of whole body radiation treatments, but all of them in patients and we have no controls and we don't have anything we can put our finger on. . . . Most of this work was unsatisfactory because the data was poor."[35] However, Shields Warren was not persuaded that experiments on healthy men would provide any more useful information and was concerned about the long-term health consequences. Warren noted that "[i]t was not very long since we got through trying Germans for doing exactly the same thing."[36] Nonetheless, General Cooney argued that even if the data would not be statistically valid, "psychologically it would make a lot of difference to the soldier if we were able to tell him that various doses of total-body irradiation were given to a group of people and here are the effects that were discerned."[37]

As we have seen in earlier chapters, the question of medical ethics was considered by the NEPA discussants. Stone urged that the committee approve TBI human experimentation in accordance with three basic principles of the 1946 American Medical Association Judicial Council: (1) "the voluntary consent of the person on whom the experiment is to be performed must be obtained"; (2) "the danger of each experiment must have been previously investigated by animal experimentation"; and (3) "the experiment must be performed under proper medical protection and management."[38] Shields Warren added that the experiments should be unclassified, so that there would be "no suspicion that anything is being hidden or covered up, that it is all being done openly and straightforwardly."[39] MIT's Robley Evans responded that "we don't have to advertise it, but at the same time it doesn't have to be concealed, as Dr. Shields Warren has said."[40] Dr. Hymer Friedell raised the question of whether decisions on these issues could be made by doctors alone: "I am just wondering whether someone else ought not to hold the bag along with us with regard to making such a recommendation. Previously in medical experiments the physicians and doctors have made such recommendations because the problem was primarily a medical one. I think this is something larger than that. It is really not a medical problem alone. It has to do with how critical this is with regard to the safety of the nation."[41]

In January 1950, the NEPA Medical Advisory Board recommended, with the exception of one member (not named), that human experimentation be conducted.[42] Dr. Stone then prepared a January 1950 paper on "Irradiation of Human Subjects as a Medical Experiment" to be presented to the DOD's Research and Development Board (RDB). The paper explained that as long as they kept doses below 150 R, the chances of long-term effects such as "leukemia could be entirely ruled out."[43] (This assertion would prove to be inaccurate; subsequent epidemiological research has shown that radiation doses at such levels will produce approximately a sevenfold increase in leukemia risk and a doubling in the risk of many other cancers.)[44] Accordingly, the experiments were designed only to analyze the acute effects of radiation. Stone extolled the "inestimable value" that would come from being able to tell pilots that "normal human beings had been voluntarily exposed without untoward effects to larger doses than they would receive while carrying out a particular mission." Stone then described a "plan of attack," in which he would start with 25 R total-body irradiation and then gradually increase the dose to 50 R, 100 R, and 150 R if no immediate effects were seen.[45]

The RDB's Joint Panel on the Medical Aspects of Atomic Warfare met in March 1950 and endorsed the NEPA recommendations in Stone's paper.[46] From there, the issue was debated by the RDB's Committee on Medical Sciences (CMS) in May 1950. When one committee member asked whether "you can get answers from people subjected to radiation therapy usually by reason of neoplastic disorders" as an alternative to experiments on healthy persons, Dr. Stone responded that it might be possible, but only if the patients had radioresistant cancers: "you can't pick lymphomas, but [rather] carcinomas [sic] types of metastases"[47]--the death of lymphoma cells would release quantities of unknown biologic chemicals and complicate the data collection.

The Defense Department shied away from making a final decision and instead deferred the matter to the AEC on the grounds that NEPA involved "civilian" as well as military problems. Accordingly, the AEC appointed another panel of experts, who met in Washington, D.C., on December 8, 1950.[48] This ad hoc "biological and medical committee," which included a number of participants in the DOD's NEPA advisory committee, addressed four questions:

  • Assume that troops are acutely exposed to penetrating ionizing radiation (gamma rays). At what dosage level will they become ineffective as troops?

  • What dosage will render an air crew . . . unable to complete a mission during a flight of one to three, four to twelve, and twelve to forty-eight hours?

  • How often may an aircraft crew accept an exposure of 25 R per mission and still be a reasonable risk for subsequent missions?

  • A submarine crew are receiving 25 R per mission. How many missions should they be allowed to make?[49]

This group of experts concluded, somewhat in contrast to Stone, that the acute effects of doses of 150 R or more would pose "grave risks" of rapidly making troops "ineffective as fighting units," but that doses held below 75 roentgens should be "unimportant in determining the success of a mission provided the crew members had not previously received an appreciable amount of radiation." (Current reports suggest that tolerance levels for acute effects may be a little higher, and that a dose of 125 rad (approximately 200 roentgens) would cause vomiting in approximately 30 percent of those exposed within twenty-four hours, and 200 rad would cause vomiting in 50 percent.)[50] They also said that air and submarine crews could withstand eight missions of 25 roentgens, but that cumulative doses of more than 200 roentgens could "substantially reduce the life expectancy of the irradiated individual." The ad hoc committee based these conclusions on "the results of extensive animal experiments, the response of patients treated for disease by X-ray and radium, observations on the effect of radiations from the atomic bombs detonated over the Japanese cities of Hiroshima and Nagasaki, and accidental exposures within the Manhattan Project and the Atomic Energy Commission."[51] Accordingly, this committee found that additional human experimentation was not needed to come up with reasonable answers.

Dr. Joseph Hamilton, a Manhattan Project physician involved with the plutonium injections, was unable to attend the December 8 meeting and sent a note to Shields Warren explaining his views:

For both politic and scientific reasons, I think it would be advantageous to secure what data can be obtained by using large monkeys such as chimpanzees which are somewhat more responsive than the lower animals. Scientifically, the use of such animals bears the disadvantage of the fact that they are considerably smaller than most adult humans and a critical evaluation of their subjective symptoms is infinitely more difficult. If this is to be done in humans, I feel that those concerned in the Atomic Energy Commission would be subject to considerable criticism, as admittedly this would have a little of the Buchenwald touch. The volunteers should be on a freer basis than inmates of a prison. At this point, I haven't any very constructive ideas as to where one would turn for such volunteers should this plan be put into execution.[52]

Following the ad hoc committee's conclusion, the AEC's Division of Biology and Medicine, headed by Shields Warren, declared "that human experimentation at the present time is not indicated." Moreover, the AEC also stated that such experiments "would have serious repercussions from a public relations standpoint, particularly if undertaken by an agency that has to do a portion of its work in secret." If data were needed, the DBM concluded, they could be obtained from the sources cited by the ad hoc committee.[53] The AEC position spelled the end of the DOD's request to do radiation exposure experiments on healthy people, and roughly coincident with the rejection of this proposal, the DOD contracted to gather data from cancer patients receiving TBI treatments.

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