Mr. MANN. So you believe, in your opinion, the treatment was being used elsewhere in radioresistant or localized cancers?

Dr. SAENGER. In the diseases that we treated, I would say yes. Mr. MANN. Quoting again from the study, this is page 14:

The committee, however, was unable to find any written protocol in which the purpose of the study, which is determined palliative effects of whole body irradiation, until the protocol entitled, The Therapeutic Effect of Total Body Irradiation Followed by Infusion of Stored Analogous Marrow in Humans was resubmitted to the Chairman of the research committee by Dr. Ben Friedman, then principal investigator, on April 13, 1967.

Dr. SAENGER. Again, I would have to refer you to our statement made to DASA in 1962. I cannot say whether Dr. Suskind's committee was familiar with that statement or not.

Mr. MANN. So your 1962 document to DOD is a written protocol? Dr. SAENGER. I think it is fairly explicit.

Mr. MANN. All right, sir. I am going to yield for the moment. I will pick up on the second round.

Mr. BRYANT. Mr. Portman.

Mr. PORTMAN. Thank you, Mr. Chairman.

Dr. Saenger, thank you for agreeing to be before us today.

Just to back up, again. My view is that the role of this subcommittee is to help determine the appropriateness of compensation for the families, and it is in that context that I ask these questions.

And first, of course, informed consent. You have mentioned in your response to Mr. Bryant and I believe in your testimony that the attending physicians were responsible for providing information as to risks, benefits and so on. I just wondered-perhaps this is in the record. I haven't seen it. And there are many documents I have reviewed. But who were these people that were informing the patients who were these the internists or radiologists? Who were the attending physicians?

Dr. SAENGER. The principal ones I have identified: Dr. Harold Perry, who was responsible for the radiotherapy in our institution from about 1957 until about 1965; Dr. Horowitz, a radiation therapist, who was from about 1965 to 1968; Dr. Ben Friedman, an internist and hematologist who was with us from about 1963 to 1965 or 1966-I can't give you these exact dates; I don't have them-Dr. Silberstein, who began in 1967, I believe; and Dr. Bernard Aron, who began in about 1966.

Now these are all board certified specialists in their fields either of radiation oncology or internal medicine, nuclear medicine. And I think they are very responsible physicians and have been very highly regarded in this community and nationally.

Mr. PORTMAN. Further, on the issue of informed consent, having heard a lot about that today and having looked at it quite a bit over the last few months, there is a lot of conflict, I believe, out there between, as an example, the Hippocratic Oath on the one hand, and codes that were adopted later, the various practices of hospitals and so on. We have heard today that standards of disclosure were evolving during this time period, the 1950s and 1960s. My question to you is, do you believe that the experiments deviated in any way from the standards that govern informed consent at that time?

Dr. SAENGER. Absolutely not. I think we complied fully with informed consent. I think we were in the advance of techniques of informed consent throughout this study.

Mr. PORTMAN. There has been discussion today about radiation doses being lethal or close to lethal. You stated earlier in response to Mr. Bryant's question that today there continue to be whole body radiation treatments. You indicated that the rads were higher, although I am a little confused as to the intervals. If you could perhaps flesh that out a little further and then just give us your opinion as a radiologist as to the question of lethal or nonlethal dose in the period of 1971.

Dr. SAENGER. When we began our works we were feeling our way very gingerly, and we believed that somewhere around 150 to 200 rads of whole body radiation was about as high as we could go without getting into trouble.

After our project was terminated, at the point when we were able to maintain better control of the patients with our autologous bone marrow infusion, we then find from looking at the literature that other centers continuing in this work, many treating the same and different cancers, were using doses of two, three and four times the size, the amount that we were using, with success.

If you go back and look at what we were doing, it would seem to indicate very strongly that the doses that we were considering as getting pretty close to a danger point were really not. And this is one of the reasons that we were able to conclude that the deaths in many of these patients, as they died, were due to the progress of their cancer, which was growing exponentially, rather than as a result of the comparatively small doses of radiation that we were giving both whole body and partial body.

Mr. PORTMAN. Again, could you just flesh out a little further as to today's practices in terms of levels of-I believe you talked about levels in the 600 to 1,200 range but indicated that treatment would perhaps be given at intervals. This is today's practice.

Dr. SAENGER. Today's practice in some institutions, they still will give 1,000 to 1,200 rads as a single dose. Now what is found in those patients is that they don't die of the acute radiation syndrome. They die of a subsequent radiation pneumonitis.

And in order to get around the problem of dying of radiation pneumonitis and still accomplish the intended therapy, which is to either treat the cancers or ablate the bone marrow, it has been found that one can fractionate the dose. And by that you would perhaps give four doses of 300 rads, say, a day or every other day, for a period of time. You would give 200 rads a day times five to get-for five days to get to 1,000 rads.

Furthermore, in today's treatment of cancer, these patients now are getting several series over a period of weeks of intensive chemotherapy, then getting this total body therapy and then going back to intensive chemotherapy. So that the amount of chemicals and radiation which are damaging to the bone marrow are really in terms of what we were doing back in the 1960's. It is sort of, I guess, fantastic. And patients are surviving this.

Mr. PORTMAN. The final question in the area of informed consent. This has to do with the selection of the patients. Many patients had a lower level of education. Many are indigent.

I know in response to an earlier question you indicated you weren't involved in the selection. If you have anything further on that, I would be happy to hear about it.

But my concern is, really, do you think that that is relevant? Does that bear on the informed consent question specifically? Would that same patient group be selected today, even with the evolving higher standards of informed consent?

Dr. SAENGER. I would like to respond to that because I think it is a very important question. It has been of great interest to me to first listen to several of the taped consent interviews which we have with several of our patients. And irrespective of their IQs or level of illness and so on, I can tell you that from my experience of some 50 years in handling cancer patients, that these patients were thoroughly aware of their situation. They understood that we were going to try and do something for them which might be helpful and might not.

In addition to that, we did something that is unique in the field of studying radiation effects in cancer patients. We had a very elaborate program of investigating the psychological and psychiatric reactions of these patients to their treatment. And part of this consisted of 5-minute interviews where the psychologist would simply take a tape-recorder and put this in front of the patient and say, talk for 5 minutes about anything you want to.

Now, what happens in these situations was that these patients are first interviewed in that fashion immediately when they began on our study program. That took us usually 2 or 3 weeks to get them all prepared, worked up, as we say, tested with our various laboratory tests and undergoing sham radiation, which we did carry out. And each time we had this interview.

Then the patients were interviewed just before they were treated, just after they were treated, and for a 3-day interval, I believe, a 7-day interval, as long sometimes as 6 weeks.

I have only listened to a few of these tapes, and I can tell you that these patients are understanding, sensitive and alert to their conditions, to their treatment, to their progress, to the fact that their tumors are growing, that sometimes they feel better, sometimes they feel worse, and they are as sensitive as any individual in this room today.

And I do not believe that all of this talk about the poor and uneducated and low IQs and so on had anything to do with their ability to perceive their situation in life and how it is progressing. Mr. PORTMAN. The next major issue is the DOD role, the Government role in all of this.

I, too, have questions about your reports back to DOD. Congressman Mann quoted from a couple of those reports.

I wish DOD were still at the panel because I would like to hearand perhaps we can now, Dr. Soper, hear from you later about other examples where DOD responded with an institution in terms of the effects versus the treatment, because it seems to me that Dr. Saenger's statement that this is what DOD was interested in and concerned about and, therefore, that was what was in the report might be something that we should look into in terms of other reporting that was done in other experiments around the country.

But my general question, I suppose, is, would you have gone ahead without DOD?

Dr. SAENGER. Yes. We had Dr. Perry. We had Dr. Kereiakes. We had the physical equipment and so on. And we would have proceeded whether or not we had DOD's support. DOD's support was not used for the treatment of the patients.

As we have emphasized, the GÃO investigated this question, and I think the conclusion is inescapable that the DOD function was entirely separate from the therapy of the patients.

Mr. PORTMAN. My final question really is how DOD used the information. There is very little in the file that I find, at least as to DOD reporting back on how it used the information that the experiments in Cincinnati provided to them. Are you aware of any DOD reports generated during the study period or after the study period as to how they used the information that was provided?

Dr. SAENGER. I cannot give you the exact times that I met with DOD people, the DNA personnel and other Army and other commands. But there were several meetings which I attended. There was data that I worked on with them to develop the manuals which they use in the field for the commanders and for the personnel in the field in the event of nuclear warfare.

I don't have the information that Dr. Soper had about the exact manuals today. But I have participated in these, and I know-at least I am led to believe that our information was useful to the DOD in this regard.

I know that some of the studies, the psychological studies were of some help in interpreting what they find is a very important consideration of performance.

Mr. PORTMAN. And you are led to believe that some of the information_provided was useful in compiling manuals

Dr. SAENGER. I attended some conferences from time to time with DOD personnel. The only thing I can't tell you today is the exact date, location of those meetings. I think I could find some of this information.

Mr. PORTMAN. I think some of that is relevant-at least in my mind it is relevant to the issue of the DOD role.

Thank you very much, Dr. Saenger.

Mr. BRYANT. Dr. Saenger, you mentioned a moment ago I am sorry. Dr. Egilman referred earlier and you made some reference to this business of treatment for nausea. And his comment was to the effect that ill patients who were nauseated were not given nausea treatment for up to three days, which was not the normal practice, as he stated it. Would you repeat what you said earlier about that?

Dr. SAENGER. What I said earlier about that was that we asked the ward personnel and the attending people not to ask specifically are you nauseated, do you feel like vomiting, because we found, as I think many of us observe in raising children and so on, if you ask leading questions you very often elicit responses, particularly for things which are somewhat suggestible such as nausea and vomiting.

On the other hand, we have taken a great deal of pride in the quality of our nursing care on the tumor wards of the General Hospital over a period of some 50 years that I have been associated

with that institution. And I can tell you at that these patients were not left all alone and completely neglected and so on. That is simply not so.

I think, on the other hand, you have to realize the situation of people who are desperately ill. They have very unpleasant things happen to them. They get sick. They throw up. They lose control of their bodily functions. They don't immediately always have someone to come and clean them up. And when family members come in and see them in these rather sad states, everybody gets pretty upset. And I have had this personal experience with members of my family, and I am sure all of you have.

But these patients under no consideration were abandoned or left out in a field and so on. It is just not so. That is not the quality of medical care that has been given in our institution during my entire career, earlier or later.

Mr. BRYANT. If a patient was nauseated, were they given antinausea medication?

Dr. SAENGER. If they complained. All they had to do was say, I don't feel good, and the patients were given whatever therapy-I mean, whether it was Compazine or some other antiemetic or

cracked ice.

Mr. BRYANT. So your only policy in this regard was don't go and ask them?

Dr. SAENGER. Just don't ask the leading question. That was the only thing that we requested. And we only requested that for a period of 3 or 4 days. This was not something that would go on for a period of weeks.

Mr. BRYANT. So for a period of 3 or 4 days, during their course of these whole body

Dr. SAENGER. Immediately after the irradiation. Immediately after the total body irradiation.

Mr. BRYANT. You made reference also to psychological isolation of the patient. Do you recall any instructions that the patients be put in rooms all by themselves and left alone?

Dr. SAENGER. I do not recall that specific incident. The wards in which the patient were hospitalized were at that time generally open wards. There would be maybe anywhere from 2 to 5 to 10 beds on these wards, more or less.

It was the custom from the time I was an intern when a patient became critically and terminally ill, having a lot of things going on, if there was a single room in the wards of the hospital the patient sometimes was moved in it for two reasons: one, that the family could be there, that they could get some care from the family and from the nurses; and also so they would not disturb the other patients who were less sick on the ward.

That was the general, I guess, nursing practice at the hospital. Mr. BRYANT. But that would be, I assume, the policy for all patients at all times, would it not?

Dr. SAENGER. That is my impression. I don't think there was anything particular-I think the patients that we treated were treated as well, hopefully better, than any other patient in the hospital but certainly not less well. They were certainly not isolated or disregarded.

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