Dr. HENDERSON. If you were a private radiologist and decided you wanted to go ahead and irradiate a group of people, I am unaware of anything that would prevent you from doing that, other than you would be subject to malpractice and other stipulations of the profession.

Chairman GLENN. Do we need legislation in this area or do you think it is adequately controlled?

Dr. HENDERSON. I would like to say at this time we are engaged in a rather thorough review of what has gone on. I think at the end of a period of time here we are going to have a very much clearer picture of what has happened, what we see as the risks, and I think at that time we would be able to better suggest whether legislation is needed, and if it is needed of what type that would be.

Chairman GLENN. Well, just with what we have done at staff level here in looking at this and some of the questions this morning, too, it indicates that this is sort of a big mushy area here as to what you can do and can't do. It leaves me a bit worried because in the past we have seen people go out and do things that we never would have believed were possible. Out of 250 million people in this country, I wouldn't say that we have eliminated all those people from positions where they might go out and do some of that stuff again.

Dr. HENDERSON. I suppose one faces this more broadly in, if you will, the practice of medicine in how do you assure that every physician is basically complying within some sort of accepted standards of practice, when indeed such standards are not well laid down. Whether megadoses of vitamins or radiation or goodness knows what else is used is indeed difficult to regulate and difficult to act upon.

Chairman GLENN. Dr. Smith, in the past has the Department had radiation experiments that were classified for national security reasons?

Dr. H. SMITH. Yes. Some experiments were classified, but we are not letting that impede us in any way, Senator, in our search into that type of work.

Chairman GLENN. Are there still experiments going on that are classified?

Dr. H. SMITH. There are no experiments going on today that are classified, none.

Chairman GLENN. And how do you follow up? If there are open experiments going on, not classified, how do you follow up to make sure that somebody isn't getting off the reservation and doing things that they shouldn't do?

Dr. H. SMITH. As was said earlier, sir, we follow the guidelines promulgated in 1991 with great thoroughness and those guidelines do include followup. I think Colonel Glenn has already covered that in some detail.

Chairman GLENN. Yes. I don't know whether you have seen this article in the New York Times today. Did you see that?

Dr. H. SMITH. By Mr. Cole?

Chairman GLENN. Mr. Cole, yes. That bothered me considerably because you say that we have had controls in place to some extent since the 1960's, correct? Yet, here we are up in the 1980's, and so

on, with 170 open-air tests at Dugway. We had these bacteria experiments that were done across major cities-San Francisco; Washington Airport in 1965 where bacteria was spread and survived as people went about their routine activities, it says here; and these experiments in 1977 where bacteria and chemical particles were sprayed over San Francisco, St. Louis, Minneapolis, and 236 other populated locations. Microorganisms were released also at Washington Airport, and so on, during peak travel to see what the results were. People were unaware of these things.

Who approved that kind of thing? These are supposed to be nonvirulent bacteria of some kind, I guess, but who knows what is virulent and what isn't, and what may affect me and not affect you, and vice versa? Our No. 1 question would be, are any experiments like that still going on today?

Dr. H. SMITH. Senator Glenn, in the spirit of your letter of invitation to testify here, we concentrated very hard and very quickly to make sure that the situation is acceptable by today's standards today, and the answer to that question, to the best of my knowledge, is, yes, we are in full compliance with those guidelines.

With regard to the particular experiments that you mentioned and were reported in the New York Times, that has been thoroughly investigated and is publicly available in reports. In fact, I am fairly certain that the Congress has been informed about each and every one of those instances. I can say with certainty, Senator, that anyone can go into the public records and obtain that information.

Chairman GLENN. It might be available, but are we still doing this? Are we still releasing anything over the general population that they don't know about?

Dr. H. SMITH. No, sir, not to my knowledge.

Colonel GLENN. Sir, if I might add, in terms of the controls on that

Chairman GLENN. Well, not to your knowledge. Would you know if it was being done?

Dr. H. SMITH. Let me defer to Colonel Glenn, who is much closer to that type of

Chairman GLENN. Would you know if it was being done?

Colonel GLENN. Sir, if the research is going to involve human subjects as the subject of research, it certainly will be reviewed under all the regulations we have discussed here. The sort of scenario you are talking about in many cases is where the humans are indirect subjects of research, unintended subjects of research. They are exposed from an occupational, environmental sort of release, and in some cases, some of the specifics you talked about, there may have been some specific release of a substance to do tracing of how far it spread. It was purported to be safe, so there wasn't the same sort of human use. They didn't look at the impact on the human other than just to say it is safe.

Today, we have, in addition to all these regulations that we have on human use, something called NEPA and all the laws involving environmental considerations. Before any research is done, whether it involves humans or not, there must be an evaluation of the environmental impact, which would include consideration of the sort of impacts on the population I think you are talking about. So I think

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you can say with some assurance, sir, that this is not going on today.

Chairman GLENN. Well, would you know about it if it was going on in the Army?

Colonel GLENN. Only if the subject of research was a human, not if humans were unintentional

Chairman GLENN. Well, there wouldn't be any reason for releasing this over all these cities, 200-and-some cities, if the object was not to see what happens to human beings.

Dr. H. SMITH. But the question, Mr. Chairman, was is that possible today.

Chairman GLENN. May we be under a bacteria attack right now, if you want to put it that way? How do I know we are not?

Dr. H. SMITH. As Colonel Glenn pointed out, they would be in violation of NEPA, and one would think they would have to have an environmental protection

Chairman GLENN. When did we pass NEPA? 1972. A lot of this stuff was run after 1972, then. Was that in violation of NEPA?

Dr. H. SMITH. I am not at all clear, Senator. We would be happy to take it for the record and look into that.

Chairman GLENN. All right. Well, give us your rundown on that. I don't want to keep into the long afternoon on this here and we are going to have to move ahead, but I was concerned about this this morning. I hadn't been aware of this sort of thing, and apparently Mr. Cole has documented these things and I am concerned. Once again, we are doing things to our own people that they don't know about.

Somebody may think that the bacteria doesn't cause any problem, but if it doesn't cause any problem then let us check it out on their own families first. I wonder how many researchers that were doing this sort of thing with the bacteria release over the cities went home and released it in their own homes at night to make sure it was OK before they released it all over San Francisco, for instance, where my two grandchildren happen to live.

Dr. H. SMITH. Mr. Chairman, we agree entirely with that position. Furthermore, the information in that article is widely available through Army reports and can be provided to any interested citizen or researcher.

Chairman GLENN. Well, OK. I don't want to push this any further here. We will have some followup questions on this, both in the radiation area and in some of these other areas, also, because I think some of things that have gone on in the past-I appreciate the IRBS and the work they are doing. It is one thing, though, to set rules. It is another thing to then find out whether people are really abiding by those rules or not.

I would not have thought that something like this was being done that he writes here about unless that went to the very, very highest levels of Government. Staff here had some indications earlier that some of the radiation experiments went up and were approved to go ahead by Robert Oppenheimer and by General Groves. I don't know whether you have gone back into your records or not to find out whether that was true or not, but staff has been told that they think that is what happened. We don't have any proof of that, so that may be one you may want to check back through on

the records, too. I don't know what we would do about it. They are both gone now anyway, but it indicates that some of things go to the highest levels and get approved.

I fully appreciate the fact that back in days past we were concerned about the cold war and did some things there supposedly for the greater good that would come out of these things, but to me it is just hard to accept that we would run experiments on our own people, whether it is in radiation, whether it is in this supposedly innocuous release of bacteria to see what happens to people. Yet, there is some indication according to his writeup here that maybe it did make some people sick.

I don't know whether there are other ways of getting this kind of information, but I know I would certainly not want to be in a city and know that they were putting something like this out without my knowing about it. If it is as innocuous as everybody thinks it is, let us try it at home on some of the families of the people doing the research first, or, as I said, out at Sidwell Friends School here or Exeter or someplace else, instead of on some of the people that we have been doing these experiments on.

I am not trying to stop all experiments. I am the last guy in the world that is going to want to stop research, but I do want to see that our people are not put in danger and not put at risk with it. We will have some more questions for all of you here, and I appreciate your being here. It has been a long hearing today and we have another two panels to go yet. So I appreciate it very much and we would appreciate an early reply to additional questions we may send back to you so we can put those in the record.

Dr. H. SMITH. Thank you very much, Mr. Chairman.
Chairman GLENN. Thank you very much.

Panel 4 this morning is dealing with research and ethics: Dr. Jack Geiger, professor of community medicine at City University of New York Medical School; Dr. Steven Piantadosi, associate professor of epidemiology, Department of Epidemiology, Johns Hopkins; Francis Massé, radiation safety officer, New England Medical Center, and MIT certified health physicist and member of the IRB at MIT and NEMC.

Gentlemen, we appreciate your being here this morning. Dr. Geiger, if you would lead off, we would appreciate it very much.

TESTIMONY OF H. JACK GEIGER, PROFESSOR OF COMMUNITY MEDICINE, CITY UNIVERSITY OF NEW YORK MEDICAL SCHOOL

Dr. GEIGER. Thank you. As you indicated, I am the Logan Professor of Community Medicine at the City University of New York Medical School and the chairman of the institutional review board for that medical school and for the City College of New York, and a founding member and past president of Physicians for Social Responsibility. So since 1961, in a variety of capacities I have been examining the medical and public health effects of nuclear weapons use, production, testing, and the like, and for the last 10 years been a member of the scientific advisory board of the Three Mile Island Public Health Fund. I am currently the national president of Physicians for Human Rights.

I am here today on behalf of a colleague, Dr. Christine Cassel, of the University of Chicago, whose written statement you have and which statement as a colleague I participated in drafting.1 So I represent that statement, and that statement in turn represents my views and I fully agree with it.

Chairman GLENN. The statement will be included. All of your statements will be included in the record in their entirety.

Dr. GEIGER. I restrict myself to a very few comments based in part on both the ethical and medical considerations that have been raised so far this morning. One is to observe that there is clearly a spectrum of research studies, experiments and procedures that we have heard about and that have been reported in the press, from those that with the addition of informed consent, some of the studies at the Fernald School, for example, might have been acceptable or close to acceptability by today's standards, to others that were not, to still others that were absolutely outrageous by any standard.

I have spent some time thinking of what an informed consent statement would have been like for the plutonium injections, and it would have run something like, sir or madam, I propose to inject into you an extremely toxic substance in sublethal doses, the name of which I cannot reveal because it is classified. This is not a medical experiment. It cannot possibly be of any benefit to you. It carries very considerable risks. Its only purpose is to set safety standards for the protection of people who are building weapons that I cannot specify. Do you agree? It is clear that that kind of experiment, the whole-body radiation experiments at Oak Ridge, are beyond the pale even by the standards of the time.

A point should be made about the frequent reference to ethical standards being different at the time. The Nuremberg Code was published in 1947 and there was awareness of that on the part of American physicians and medical investigators. It is, I think, to the general discredit of the profession that it took until the middle 1960's and Henry Beecher's article in the early 1970's for this to be more widely adopted and codified.

Chairman GLENN. Could I ask a question on that?

Dr. GEIGER. Yes.

Chairman GLENN. Was it codified? What is the legal status? Because we are signatories to the Nuremberg Code or the Helsinki Accords, that doesn't carry the force of law in our own country, does it, unless there is further legislation?

Dr. GEIGER. I don't believe so. The first incorporation into Federal law that I know about, and I am not a legal authority, was the amendments to the Food, Drug and Cosmetic Act of 1962. There are various internal regulations that have been referred to that preceded that, but as you have pointed out, they don't clearly have the force of law.

There is, however, long before the Nuremberg Code the principle that applies, at least to physicians, going back more than a millennium to the Hippocratic oath, and it is called, first do not harm. If one looks at at least physician participation in a variety of these

1 The prepared statement of Dr. Cassel appears on page 108.