Advisory Committee on Human Radiation Experiments Interview with DR E Saenger by DR R Neunmann, G Stern, and G Whittemore

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relation between the work we did f o r DASA and the care of the patient. The finances, anything conneczed with the care of zke patient, his disease, h i s course, his medication, etc., iz no way ever was gaid for by government funds. And the reason for =kat was that under no conditions did I want the patient or myself o r any of my group put into a situation where somebody says, ah hah, the reason that patient got that treatment was you bought him with government money. There was nobody who served as a volunteer being paid for as a volunteer because the government paid for his care. If you recall, that was the finding of the GAO who came out here and w e n t through us from cover to cover in 1970 or 71, just on that . more interested in the scientific design and the way I mentally saw what you were doing is you had this palliation program; m y 5 e is,a better word than protocol, where you're treating these aatients with whole body radiation. On tog 0 2 that, then, you set scme money to draw the samples to do the military work. I'n more interested actually in the underlying thing, was that a very informal study that you're really clinically treating them and then - or did you really have a protocol tu assess DR. SAENGER: You do not find a protocol; what we were dzing, we were seeing patients, either in the t'unor clinic o r on tks tumor . ward, and we would determine in each individual * case whether we .

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L/ whole body radiation. Competing wiz:? this, was %:other group of people who said, we sure would l i k e zs see wkaz zitrosen mustard would get the patient. We had tumor conferexes 23 a semi-formal basis, not every patient went through every step, but between the tumor clinic and the tumor conference in the tumor ward, there were rounds that were made, the rounds with attenbhg I;i.,ysiciansand the residents, these patients were seen ar,d they were eiscussed at some length. Were we to show you the charts, which you will have to take my word for it, there were notes in there saying that this patient, it was decided that this patient should get this treatment or that treatment, and there were a group cut of about 115 patients, there were about 20 patients who 30: get any therapy, either we thought they were too far a&mrmd, a zauple of them we couldn't find any tumor in them when we look& fcz it. One or two of them refused therapy, there was a whole variety of things. Not every patient got treated. It turrrs out iZ ycz look at the 88 the 20-odd patients, I think there were & c i x 25 over a ten-year period, there was a ratio of about 2 or 2-1,/2 :Y^9 patients who were rejected, not treated. GARY STERN: I guess what I'm curicus about 15, szill it seems the interrelationship between the two, the =OD wcrk c 5 the palliation work, they still started contemporaczcusly cz di5 you teletherapy for the purpose of palliation prior to tke DOD -scrklL/

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GARY STERN: That's righ:. DR. SAENGER: No. That started when we started - this grotocal permitted us to get a technique going in trying to look at whole body radiation in comparison with other forms of palliation. GARY STERN: would you have done it if you hadn't gotten the DOD money, or could you have? DR. SAENGER: I think we certainly could have. What we would have done, I don't know, but what this permitted was a framework of a f- way to evaluate these various components of therapy, testing f o r indicators of radiation and so on. It gave us a fonnal structure, a semi-formal structure. If you asked me what the structure would be like today, were we doing this same thing, it would be quite different, as you c m appreciate. More specific controls, different method of selecticr,, somewnat different methcd of selection of patients, and a lot different tests, etc. DR. NEUMANN: So you didn't really sit down ahead of time f o r the palliation part of this and say, we'll take five patients t3 100 rads, and five to 150, with the oncologist did you have some s o r t of - if not written on pager, Cesign f o r this, or was it-case *3y

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really tell you at the moment, how w e detarmined you w o u l i get 100 or IS0 or 200 rad. One of the things we did determine was =hac IZ your tumor didn't seem to be so widely spread, we would t z s a t with you partial body radiation rather than whole body radiaticrr. We would also know that we could give higher doses. We were terribly afraid in those days of having the radiation depress the bone marrow, and to that extent we went off on a course to develop autologous bone marrow reimplantation because we wanted some way to protect these patients. It turned out, as we began to look at the literature in the 70s and '80s and so on, people around the country were giving 400, 600, 800, 1000 rads in one shot and thinking nothing of it. Why we were. so afraid, I really can't tell you, except that our patients were sufficiently far advanced that they may have been more sensitive to the effects of radiation and chemicals and all the other things that were done to 'them. Some of these patients were given whole body radiation, then they were .given localized radiation, then some of them were given chenicals, these were all desperately ill patients .by and large, wi->C.rA a ve-y restricted outlook. I'm telling you what we did. Whether we did not have as formal a design as I would have. GIL WHITTWORE: Was there any use -of gauging the amount a f dcse according to the immediate symptoms that the patient would have - DR. SAENGER: I think what we did was we tried to gauge the amount ' of radiation by the level of involvement. At some point, if we saw

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L was a judgment call, it was not a - I c m ' c ZSLL yzt: there were strict rules that we had, we did net 'nave scxict r ~ l e s . GIL WKITTEMORE: Of these radiations, how many would you yourself be present at, how many were done by your team? DR. SAENGER: None. I purposely did not involve myself in patient selection because I was afraid that I would bias the judgment of the physician. In other words, the physkians include the several therapists, radiation therapists, a couple of internists and some of the resident staff were involved. I felt I was up there saying boy, I sure would like to see that patient get treated and the patient in their judgment shouldn't have Seen treatad, or I might say why don't you give him a lot, and they thought they should give him a little, or 'vice versa. I didn't thirk my judgment was GIL WHITTWORE: Do you think as what haFcens sc ze the s with, senior scientists supervising a staff that the staff would second guess what sort of patients you would like, ev&q if ycz yczrself were not DR. SAENGER: The only thing we said was we wantad patients who did not have leukemia, lymphcma or Eodgki-ns, thcsz were the only restrictions. I think we had one or two like that.

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GARY STERN: Radioresistant t s e cf cii~csrs? DR. SAENGER: Those at that time seer.& to be radioresistam. If you go in the literature,. as we've docmented, there have been a whole bunch of patients with these so-called radioresistant tumors have been treated over the years and even in the '90s. GARY STERN: One of the striking things, just from reading all the documents on record, apparently there's discussion at ORINS in their treatment, their TBI treatments, a suggestion by the AEC, I think, that they should do a comparison between radiation and chemo on some of the radioresistant tumors. And Lushbaugh, the response was, oh no, we can't do that, it would be ethically unsound because the doses would have to be so high to have any effect on those treatments, but then in contrast, they said, on the other hand, it would be t w t i n g because they would be hematologically clean to do that. This was in 1966, I think, this document. That's what's sort of striking, that is what's happening here, that they had rejected over there. I don't know if you're aware of that. of our data in some of his gapers, as you know, and we've had extensive discussions, but their the'racy was not Dart of my life. I did not have any input or action in regard to how much they should give under what circumstances. Yes mam?

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cannot find that I can be of assistance to you? GARY STERN: Cobalt 60. DR. SAENGER: What was it, the history of the cobalt 60. DR. m: One of the accusations or allegations that's been made is that you selected these solid tumors that wouldn't necessarily necrose with the levels of radiation that you weregiving pxposely so as to not mess up your assays, because if you treated lymghomas or leukemias where you got by any chance a release of a lot of intracellular proteins and nucleic acids that would have, confused the protocol that you were doing with the biologic dosimeter. How do you respond to that type of statement? -DR. SAENGER: I never heard that criticism. DR. NEUMANN: Well you may. I've read that but DR. SAENGER: It slipped by me. DR. NEUMANN: The claim is' that there was sufficient literature at that point in time to suggest that the doses you were using would

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thinking about that, if you were IccXLxg ? o r a Siologi:: marker, the last thing you'd want would be a I c c cf cell eeath frcrn scrnething like leukemia or lymphoma, and have the release of all these intracellular components into the blood and urine in which you were searching for a marker. DR. SAENGER: I would have argued the other way and said that' if we could get any release of a mixture of whatever it was, that we would have something to look at, we'd have a place to begin. We were so concerned with the safety of what we were doing, as contributing to the demise of the patient, that we simply never got ug to these upper limits. These other people, I read these other papers and I'm just amazed at what I would consider at the time would be taking a great risk, apparently these people, it didn't faze them at all. It didn't seem to make any difference. [Saenger clarification - In our 1973 paper, relief of pain ahd decrease in tumor size was documented respectively in 31% of 85 patients.] G'ARY STERN: They were still having the effect of the suppression, even at your level. DR. SAENGER: If we had thought the?= would be supgressic3 at this level, because these curves rise very rapidly, if you look at any measure of radiation effect like that, the' fatality curves are very steep rise in relation to dose, the more you protract it, vhe less the slope becomes.

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GIL WHITTEMORE: These gapers yc: .r,ezzi:r,ed k - r i z ; read, were thess ones you were reading at the time?L DR. SAENGER: No, they are ones I've 'seen reading since. I think if I had done more of this and not been so preoccupied with the ' biochemistry, we would probably have given larger doses. DR. NEUMANN: When you discussed with the military the whole concept of the program, did they share with you the data they had already . at that point from the experience in New York and Texas? DR. SAENGER: I don't want to be critical of what they did or didn't do. I do not recall that they sent me a big packet of re-- material. I do know that I did get some material from time to time k6 I would get regorts. ' The reports that we mde would were distributed, there's a distribution list in the back. I'm not really clear that f got what you said, but .I don't want to say that they didn't send them to me. It may have been my poor filing DR. NEUMANN: At least you don't remm2er seeing, both places had kind of poor results and confusing results. . You don't remember being discouraged by seeing anything like that, or the military

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I/ Houston o r New York, but I don't recall being there, I ion't recall who was there or what we talked ahcut. DR. NEUMANN: How about when they sent you the contract and the first check, did they send along any regulations on human clinical research that they had in place? GARY STERN: Just to follow up what we talked about a while ago, these are the various regulations, this was the Secretary of Defense memo from ' 5 3 , then it was implemented by the Axmy in June of ' 5 3 &d then there's a followup by the Secretary of the Army in November of ' 5 3 saying that it agplies to the Army labs and theL. contractors, and what we're trying to trace, the Committee is, how tdese things were implemented and whether in any course of your involvement in the Army and then as a contractor, you got theseI protocols or procedures. DR. SAENGER: Those two I've never seen. The ones by *e Secretary of the Army. GARY STERN: You said that you had =ever seen those memos DR. NE-: They never sent mytking like that alcag with the

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b Mr. Steven, Secretary of the Arrny, which I've never seen, I don't think you've seen it either. Here's another one, 30 June ' 5 3 f r m the Assistant Chief of Staff, G-4, and we've never seen that. The one we have seen is the one of the Secretary of Defense. And we saw that only recently and as a result of the testimony of m. Soger and the Judiciary Committee's hearings here when he pointed out that thing surfaced in 19175. DR. -: So they certainly never sent. any instructions to the - best .of your knowledge, along with the contract. DR. SAENGER: Give me about two minutes. I prepared here a - document, or m. Parker and I prepared a document here which describes 'the actual regulations that either the HEW or DOD issued that I could lay my hands on. ' They're interesting because they sort of …