Interview with Sheilds Warren -- 4/9/74 L. A. Miazga, Sidney Marks, Walter Weyzer LAM: Well, thank you very much Dr. Warren for taking your valuable time to meet with us and talk to us about our problem. As you probably know, the Commission has aksed us to conduct an inquiry into this matter which involves the injecting of plutonium into patients at a number of hospitals. SW: Right. LAM: In the conduct of our inquiry, we propose to develop what happened, why it happened, how it happened, and also the benefits to science from this program. We will present the report to the Commission. What the Commission will do with the report, we are in no position to say, but we are going on the premise that it will be made public. SW: Yes. LAM: In our discussions with you, I think there are two fields that we might touch upon: one is the things that happened in the Commission while you were a member of the staff and of which you have personal knowledge; the other field of interest would be things that happened before which you know from what others told you, but which would be valuable to us in pursuing other avenues of our inquiry. Now when did you join the staff of the Commission, Dr. Warren? SW: In, I think it was November of 1947, and I stayed as a member of the staff until June 30 of '52. Then I became a consultant and was a member of the Advisory Committee on Biology and Medicine for a five-year period. And then I have stayed on as consultant up to the present time. 1 SW: This was the use of some patients for radiation therapy when there was not a clear consensus on the part of the medical profession as a whole, that radiation therapy was the soundest treatment for cases of this type. These, as I recall it, were cases that Bob Stone felt, in light of some of the experimental work that had been done on animals, would be worth trying on humans. The weight of evidence was that radiation would not do anything for them, and there was this issue was raised. Incidentally, because of the course of these things, of the studies, some blood counts had been done on them and it was the dangerously low blood counts on them that sort of set off an alarm clock in ACBM's mind when they saw it. No, this was not anything to do. And the reason Hamilton was in on this was, subsequently, was because we thought that there needed to be, as these new sources of radiation became more widely available, a better means of control than existed at the present time. And since Hamilton knew more about metabolic pathways than anyone else, he was a logical member to be on this. And in this particular thing, there wasn't anything to do with the injection of plutonium. SM: Was the issue of the injected people then ever brought in any formal way to the attention of AEC or ACBM then or was it just this informal discussion where you became acquainted with it? SW: I think the way it was handled was that Alan Gregg and I agreed that the best way to do was to see that the rules were properly drawn up by the Isotope, Humans Applications Isotope Committee, which had then come into being, so that use without full safeguards could not occur, and that we saw no point in bringing this up after the fact as long as we were sure that 3 nothing of the sort could happen in the future. This was because we assumed that those patients were all dead at that time. We hadn't realized that any of them were still alive. LAM: Was there any discussion as to whether or not the patients had consented to be subjects for these injections. SW: Yes, because we were reasonably sensitive to these things at that time and I'd always made a point in explaining to the patients I'd injected what went on, and Hamilton told me that he had explained to the patients that their, they would receive, now I've got to try to put my thoughts in order in this, that they would receive an injection of a new substance that was too new to say what it might do but that it had some properties like those of other substances that had been used to help control growth processes in patients, or something of that general sort. You could not call it informed consent because they did not know what it was, but they knew that it was a new and to them unknown substance. There was not anywhere near the alertness to informed consent, of course, in those days that there is at the present time. I'm pretty sure that this was an accurate statement because Hamilton was a very meticulous man, very high scientific and professional standards. SM: Dr. Warren, may I flip this over and ..... SW: Surely END OF FIRST SIDE OF TAPE SM: He had knowledge of the Chicago-Rochester patients at that time. He had three of his own that he was telling you about. Did the people in these various installations know that the others were doing that and was it a type of coordinated activity or? 3