DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995. TAB D-4 þþþDRAFT þ FOR DISCUSSION PURPOSES ONLYþþþ MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: April 29, 1995 RE: Robert Stone and the Nuremberg Code Wrestling with ethical questions was nothing new to Robert Stone, the radiologist who served as director of the Metallurgical Lab's Health Division from 1942 to 1945. When he returned to the University of California in 1945, Stone continued work he had begun during the war conducting radioisotope and teletherapy research under the Manhattan Project's Contract 48-C. Part of this work included a continuation of teletherapy for arthritic patients. For reasons that remain unclear, Stone came under fire for this work from the Advisory Committee on Biology and Medicine in 1948. ACBM Chair Alan Gregg, in a particularly blunt letter written in October, 1948, said, "...we [members of the ACBM] agree with those who believe the x-ray treatment of arthritic patients you havie been giving patients is not justified, and that they do not wish to collaborate in clinical investigations with physicians in whose considered judgment they do not have confidence."1 [Alan Gregg to Robert Stone, 10/20/48. See Attachment 1.] In the spring of 1950, Stone was asked to prepare a report for the Air Force outlining recommendations for human experimentation in regards to its Nuclear Energy Propoulsion for Aircraft (NEPA) program. Stone's report identified the hazards, precedents, and necessary precautions to be taken when using human subjects. He also specifically endorsed using prisoners sentenced to life for long-term studies because "[they] are the one group of people that are likely to remain in one place where they can be observed for a great many years."2 [Stone, Robert. "Irradiation of Human Subjects as a Medical Experiment," 3/8/50. See Attachment 2. Cited previously in History of Ethics Policies and Practices, 12/6/94.] While he describes would-be subjects as "volunteers", Stone does not mention informing subjects as to the risks of exposure to radiation. In 1952, Stone drew a line he felt researchers should not cross. While serving as chair of the University of California, San Francisco Cancer Board, Stone urged a proposed experiment be 1 rejected on the grounds that it violated the Nuremberg Code and the guidelines adopted by the American Medical Association. The experiment, first proposed by Stone's colleague Dr. Bierman in April 1952 and resubmitted the following month, involved the transplantation of malignant melanoma from one terminal patient to another patient with different malignancy, but who was also terminal. The proposal had been tabled during April's meeting due to Stone's objection based on his belief the experiment would violate the Nuremberg Code.3 [Cancer Board Meeting, 4/23/52. See Attachment 3.] At the May meeting, Stone asked Bierman if he had read the Nuremberg Code regarding the use of human subjects: Bierman: Yes, I have Stone: And you still feel you want to do this? Bierman: I certainly do. I do not think this compares to Nuremberg. These patients are doomed to die of their disease and nothing known can be done for them. Perhaps this will not do any good for the patients, but the accumulation of knowledge will eventually help people.4 [Cancer Board Meeting, 5/21/52. See Attachment 4.] Later, Stone, referring to Point Nine of the Code, asks Bierman if he could bring the experiments to an end. Bierman: Yes; you could cut out the lesion. Stone: You couldn't stop the metastases. Bierman: The patient already has metastases. He is already terminal. Stone: That doesn't matter. I can't see where in any sense the experiment could fit under the War Crimes Tribunal or the A.M.A.'s Codes of Ethics. Bierman was comfortable with the ethics of his proposal. Stone, however, clearly was not. The proposal was tabled again. Because Staff has not been able to find subsequent Cancer Board Minutes, it remains unclear whether this study was ever carried out. While Stone had urged the NEPA Advisory Committee to accept the A.M.A. guidelines in 1949, other studies and discussions conducted or approved by Stone make his ethical stance appear inconsistent. Whether it was the design of the experiment, the lack of therapeutic value to the patient, or the lack of prospect to apply the knowledge gained that Stone objected to is unclear. The exchange does show clearly, however, that Stone was aware, down to singling out the specific point, of the Code and the A.M.A. guidelines and rejected the study on this basis. 2