Attachment 2 IRRADIATION OF HUMAN SUBJECTS AS A MEDICAL EXPERIMENT Robert St. Stone, M.D. Professor of Radiology, University of California School of Medicine San Francisco THE NEED If the Air Force, with the help of Nepa, succeeds in getting a nuclear powered aircraft, it is very unlikely that it will be possible to shield the crew in such a way that they will not receive larger than maximum permissible exposure to irradiation on any one mission. If another war develops and the Army is called upon to occupy territory that has previously been bombed by a nuclear powered weapon, the troops will have to be exposed to greater than usually permissible amounts of radiation; and the same can be said for the Navy if the men because of necessity have to operate a ship that has been contaminated. In all of these instances both those who have to direct the forces and the men themselves will want to know what the risks are at various levels of radiation exposure. It is extremely important that those in command can talk intelligently and convincingly from experience gained on human beings. During and since the last war, millions of dollars have been spent by the O.S.R.D., the Manhattan Project and the Atomic Energy Commission to carry out experiments with animals aimed at determining the effects of levels of irradiation, using single, multiple and chronic exposures. In general, the conclusion has been reached that, not only each species of animal differs from every other in their responses, but also various strains within a specie differ. The differences can be ["illegible"] both when studying the lethal effects of large doses and minimal effects of small doses. Moreover, it has not been possible to get agreement as to how FAIRCHILD ENGINE AND AIRPLANE CORPORATION NEPA DIVISION, P.O. BOX 415, OAK RIDGE, TENN. 1 SO456 "illegible" "illegible" on animals to the results to be expected on humans. The Radiologists, through a committee appointed by the Radiological Society of North America, tried to reach some conclusions from their clinical experiments with patients as to what change might be expected from various levels of radiation. The answers given by the various doctors to questions asking for the amounts of radiation required to produce specific effects were so divergent that one cannot use them with any feeling of confidence. While some physicians are willing to make very positive and definite statements, others with equal experience in therapeutic radiology are willing to contradict the first group. All of which means that from previous experience no uniform conclusions can be drawn. When anyone attempts to tell people that it is perfectly safe to do a particularly hazardous job, using as the basis of their statement animal experiments, it does not have nearly as convincing an effect as the statement that previously human beings have gone through similar experiences without deleterious effects. THE HAZARDS When one speaks of doing experiments with radiation exposures using people, it is necessary to consider what type of exposures are contemplated. With the use of animals it is frequently customary to start experiments with exposures that will cause the death of the animal and from that figure work down to the dose that will cause the minimum detectible changes. The procedure could not be contemplated in the case of human experiments. Having learned from animals the qualitative effects that are to be looked for, one can start with minimum doses which will be expected to cause no detectible FAIRCHILD ENGINE AND AIRPLANE CORPORATION NEPA DIVISION, P.O. BOX 415, OAK RIDGE, TENN. SO456 2 effect and work from these to higher levels where minimum effects might be detected. It must be admitted that any amount of irradiation causes some genetic effects, but within the ranges that should be utilized from human experimentation of the number of increased genetic changes would be so small as to be undetectable. One effect of irradiation which could be detected when no other effects were discernable was the shortening of the life span. However, this can be detected at low levels only by statistics covering whole groups, not in a particular individual case. It would therefore be somewhat theoretical in the ranges that should be utilized in human experiments. Changes in the peripheral blood would probably be the first change to be noted within the low ranges of exposures of humans, but at the low levels of exposure would be slight and transient. Members of the Nepa Medical Advisory Committee drawing on their own and their fellow scientists' experiences, felt that with doses below 150r there would be so small a chance of producing any late effects that such effects as the production of leukemia could be entirely ruled out. A plan of attack could be to first expose some people to 25 roentgens of total body irradiation and observe them for a period of time. Such a level of exposure is not too uncommon in the practice of radiology. It has been used in the treatment of patients with arthritis, generalized cancer, polycythemia vera and leukemia. If and when it is found that a significant number of relatively normal people exposed to 25 roentgens have shown no significant changes then the experimenters could be "illegible" double "illegible" done, namely, 50 roentgens. The next logical step would be to give 50 roentgens and repeat it in a week; if nothing happened at this level they could then proceed to expose normal people to 100 roentgens and probably to 150 roentgens. Exposure of FAIRCHILD ENGINE AND AIRPLANE CORPORATION NEPA DIVISION, P.O. BOX 415, OAK RIDGE, TENN. SO456 3 "illegible" "illegible" "illegible" "illegible" "illegible" were sick. From this experience with sick people it seems unlikely that any particular person would realize that any damage had been done to him in such exposure. To be able to tell a group of 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, would be of inestimable value. The extremely small hazard of undetectable genetic effect undetectable effort on the life span and possibly slight effect on the blood picture are the extremely small hazard that must be weighed against the value of having actual experience with exposure of humans. PRECEDENTS The use of human beings in medical experiments is not new and the hazards involved in any particular experiments have often been much greater than those contemplated here. In fact one might say that the mass voluntary experiment which the American public is now carrying out with the antihistaminics is fraught with more uncertainty than would be those proposed experiments with radiation. No one has as carefully studied animals taking antihistaminics over a long period of time as they have studied animals receiving radiation. Without going into ancient history one might point out that in 1798 Jenner used human beings to experiment with his vaccination against smallpox. The experiments of Walter Reed with the yellow fever is another evidence of the uses of human beings for medical experiments even when the possible result was death. During the recent way, prisoners in federal and state prisons were used in several different types of medical experiments, notably those involving the testing of drugs for the treatment of malaria and those involving the use of FAIRCHILD ENGINE AND AIRPLANE CORPORATION NEPA DIVISION, P.O. BOX 415, OAK RIDGE, TENN. SO456 4 "illegible" "illegible" unnecessary physical or mental suffering. PRECAUTIONS When the experiments are done they must be conducted by scientifically qualified persons. Adequate animal experiments and medical use of radiations on sick people have already eliminated any possibility that death or disabling injury will occur as a result of the proposed experiments. The use of patients (sick people) has not given all of the results desired because they were abnormal to begin with and often respond abnormally. WHY USE PRISONERS If one were to be satisfied with the results from radiation exposure that might occur within the first few weeks or months, any group of volunteers would be useful, but since one wants to know what will occur years after an exposure it will be necessary to have a group such that all of them can be followed for a long time. Life prisoners are the one group of people that are likely to remain in one place where they can be observed for a great many years. LOCATION OF EXPERIMENTAL APPARATUS To carry out experiments of the type envisaged will require that the conditions of exposure be as nearly similar to those of members of the armed forces as possible. To meet this condition requires that the body as a whole be exposed rather than any part and that the exposure be with a penetrating type of radiation. Of course the best source of radiation would be an atomic pile shielded in one area by the same materials as might be used in an aircraft. This would be an extremely difficult procedure and would tie up a nuclear power plant for a considerable amount of time. The conditions could be moderately simulated by using penetrating x-rays from a 250 or more kilovolt x-ray machine or by using the gamma rays from a radiocobalt bomb. In either event the source of the radiation would have to be at a considerable distance from FAIRCHILD ENGINE AND AIRPLANE CORPORATION NEPA DIVISION, P.O. BOX 415, OAK RIDGE, TENN. SO456 5 "illegible" "illegible" volunteers. This requires a relatively strong source, a relatively large room and adequate protection around the room. This would be a rather expensive installation and therefore could not be moved around the country to different locations. A large prison with a large relatively fixed population would seem to be the ideal place to establish such an installation. In addition to the requirement for irradiation, it will be necessary to have good clinical facilities and laboratories to carry out a number of tests by a relatively stable group of investigators. The constance of the population, the ability to have continuity of observation, and the economic use of equipment -- all point to the conclusion that a prison provide the best location. OTHER CONSIDERATIONS It should be borne in mind that for the purpose of obtaining short term results, other types of volunteers than prisoners might be used and valuable information obtained. Patients with incurable cancer such as those having multiple metastases might volunteer. In order that the results from experiments using them could be of any value, only those should be used who could be expected to be free from constitutional symptoms from their cancer for several months following their treatments. Certain scientists might be willing to volunteer for specific doses, "illegible" "illegible" again the likelihood of their being followed with any consistency of "illegible" "illegible" over long periods of time is slight. They move around the country "illegible" "illegible" clinical and laboratory groups could not follow them. There are numerous people in the general population who might volunteer their services, but here again the possibility of consistent controlled observation is the big handicap. The use of individuals below 21 years of age should not be permitted FAIRCHILD ENGINE AND AIRPLANE CORPORATION NEPA DIVISION, P.O. BOX 415, OAK RIDGE, TENN. SO456 7 FAIRCHILD ENGINE AND AIRPLANE CORPORATION NEPA DIVISION, P.O. BOX 415, OAK RIDGE, TENN. below the menopause (unless they have incurable cancer) probably should not be used because of psychological factors. CONCLUSIONS Most people fear known hazards to life, but when they can calculate or think they can calculate the risk and when they understand or think they understand the hazard, they are often willing to go ahead. On the other hand, when the risk is not calculable and the danger is not understood, people are more likely to be mentally disturbed at exposing themselves to such conditions. While a great deal is known now about radiation hazards insofar as animals are concerned, we know relatively little so far as the normal healthy human being is concerned. We know that radiations can kill people from the "illegible" "illegible" at Los Alamos, Nagasaki and Hiroshima; but we do not know the dose "illegible" "illegible" to kill. We know that doctors who have received daily exposures "illegible" "illegible" normal amounts have developed cancer of the skin or leukemia, but we do not know the doses that they received. With the increasing use of "illegible" "illegible" for diagnostic purposes and of radioactive materials for investigating "illegible" "illegible" diagnostic and therapeutic purposes, we are likely to learn more in the future about single and repeated exposures to radiation, but the date will "illegible" "illegible." The value of one or two good controlled experiments on "illegible" "illegible" over a period years would be of inestimable value to the advancement of knowledge of radiation effects. The ability to say to armed troops and civilian communities that you know from experiments on humans what the effects of "illegible" radiation will be both in regards to short term and long term effects, and thus to place their knowledge of radiation dangers in the same "illegible" as the knowledge of the hazard of flying over enemy territory, would be of inestimable value. SO456 COPIED: 7/5/74 RECORD GROUP: #52 ENTRY: #15c FILE: L5 5