many congratulations, and perhaps rightly so. Across the ocean in Great Britain, there has been a very strong hue and cry that this was an unethical thing to do, despite what we learned. An experiment is only ethical from its inception, and not after the fact if you learn something that is of importance.

Well, this kind of thing leaves us with an enigma. We don't have a specific code. This kind of commission could establish such guidelines, not to be restricted, and this is, I think, what bothers most people, concerns most physicians, concerns most scientists. Such a commission could lay down rules carved in stone that would make it difficult for us to deal with human experimentation, this is not what we are seeking. What we are seeking are guidelines which we can look at and use in a helpful way in human experimentation.

All experiments must eventually come to the human being. The study of mankind is man, and as a result, after adequate laboratory investigation has been done, it must be translated to man. Human experimentation goes on today, will continue to go on, and human experimentation has lead to the development of anesthesia, antisepsis, anything you want to name with respect to our general knowledge in our current level of medical competence.

So this must continue on, but we must have guidelines to follow, and these guidelines could be drawn up by such a commission not to be restrictive, but to be helpful.

In addition, I would hope that such a commission would establish an ongoing body, whatever that would be, that could be used as an appeal area, very much as we have our own legal appeals today.

So when medical ethics are judged by peers at the local university level as far as ethics are concerned, there would be a level where you could now respond to a national commission, with respect to specific guidelines for particular cases.

At the present time, the restrictions from the FDA are such that they say that no drug can be given to humans unless it has had adequate human trial. Yet try to get that human trial. It is practically impossible today. It is prohibitive today. I was told by some drug companies that they wouldnt develop a new "pill tomorrow, a pill like a contraceptive pill that we have, because it would be impossible to administer such a pill to a large majority of people without having human trial, without having adeqaute evidence to state that it is safe in humans.

Yet, where is this evidence going to come from? If you try to do it in foreign countries, then you have the problem of exploration in utilizing other countries in "experimentation."

What I am saying is that human experimentation must go on. It must continue. What it needs is guidelines, guidelines of behavior, and guidelines which I hope such a commission would address themselves

to.

Senator MONDALE. The very fuzziness of this area may be a greater threat than the establishment of guidelines.

Dr. NAJARIAN. If there are guidelines and you could say, "All right, you have met these standards," let us set standards. Now, informed consent, Senator, is absolutely impossible. There is no such thing as informed consent. The only time I can do an experiment even to give a pill to somebody, another human being, and have properly informed consent is if that other human being perhaps is a physician, because he

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has to have that much background in order to perceive all the risks apparent now and in the future, that could occur from such administrations, whatever it is, whatever the medication might be.

So this informed consent, de novo, is impossible to achieve.

Yet, some form of informed consent can be achieved and these kinds of guidelines could be given.

The commission will address itself to legal problems, and these are many. One of them I brought out as far as the Federal Drug Administration is concerned, which is now in the situation of requiring something which they won't allow to happen. We have recently come up against this ourselves. We have developed a serum at the University of Minnesota which has improved cadaver transplants, transplants from people who have recently died, kidneys, for example, from approximately 50 percent up to the range of 70 to 80 percent survival of these kidneys with the use of this serum.

It is raised in horses. This has resulted in 40 to 50 percent better salvage of kidneys.

Yet, today, we can't manufacture that serum, because we can't get anybody to support it, we can't sell it, we can't give it to anybody. We can give it within our own institution, but if we are to try to set it up for other institutions, we can't even receive cost recovery for it, so that we could make more of the serum to be distributed for further clinical trial, because the rules are that restrictive.

I think the rules and the legal implications must be defined much more clearly, and must be defined in a much less restrictive way so that these things, as new things come along, can be achieved.

If we had a serum, a vaccine against cancer tomorrow, you couldn't get money to support it. You couldn't give it to anyone, and you couldn't pass it across State lines, and it would be extremely difficult in order to develop such a vaccine, no matter how good, at least on preliminary trials, that appeared.

There are other obvious things in a legal sense, such things as a definition of death. We discussed that this morning. What has happened is that a variety of people and a variety of groups have looked at this, and they all have definitions of death, as far as brain death is concerned. The group at Harvard has set its standard, the AMA has a stand on this, and other groups do as well. They are all different, they are all relative, and in each institution perhaps a standard has been

established.

What I am saying is that there ought to be, here, again, some specific guidelines on what we consider a definition of death in the modern sense with the advent of the machinery we have and the capability we have of extending life and continuing heartbeat and breathing in a patient who is "brain dead."

So these are the issues, basically, to have this commission study and recommend solutions to these problems. One, the social problems with respect to priorities, and hopefully this would have a meaningful input into the legislature if this is a Presidential commission.

Two, to address itself to the ethical problem, many of the ethical problems are fabricated, but many other ethical problems are real and do exist. They need some reasonable guidelines in order to follow, and perhaps some sort of appetite mechanism for local groups and universities to appeal to.

If the commission can do this, they will have done an awful lot, and they will have made a great stride forward with the Federal Government assuming a responsibility in putting a cohesiveness into the medical associations and medical institutions that are looking at the problem independently, none of which are really pulling us together in an amalagamated form. There could be one place you can go to find. and answer, or at least an area of appeal or an area of definition.

In human experimentation, what are the benefits to society and the jeopardies of society. Therefore, I strongly urge the passage of your resolution, Senator.

Senator MONDALE. Dr. Najarian, I am pleased by your strong statement in support of this proposal. It is an excellent statement.

It is my impression that some of the research persons in medicine fear that there are more risks to be gained from public ventilation of these problems than it deserves.

Others, like yourself, seem to believe that great progress can be achieved through public ventilation.

How do you answer those who have this fear? As I understood Dr. Duval, he felt a public review would freeze and paralyze guidelines and rules and regulations, and thus we would not have the flexibility we need.

The assumption underlying that must be that the public would be unduly rigid and lack the understanding needed to respond intelligently. I think he saw it basically as a fear or a risk. You seem to see it as an important new possibility for public understanding, for support, for guidelines that would actually help research and

treatment.

Dr. NAJARIAN. I think this is basically true. As we look back on medicine, and we find that, years ago medicine was practiced by pulling up a sack of digitalis leaves, and holding hands and reassuring patients. This was medicine, and there were very few things we could do.

Today medicine is different. Today we have a potential of doing an awful lot in medicine, and we do, and I think basically I give a lot more credit to the American people that this kind of public information is wanted, if they were to learn that experimentation is needed they can accept it. But the question always arises about human guinea pigs.

There are no human guinea pigs. If the guidelines are there, if you are not taking risks on these people that they are noninformed of.

Yes; there are skeletons in the closet, the travesties that we spoke about today, the injection of cancer cells and things like that, those exist. But they help us to draw up rules and guidelines. At the same time, the experimentation leads to the proper delivery of medicine to the people, and I think the people would respond to that.

I think your recent Amchitka thing is about as good an example as any. If people really knew the information behind that experiment, there probably wouldn't have been such a hue and cry against it.

The same thing is true of any experimentation. If you know the facts, you can't philosophize on what the potentials are, because they are presented to you, and it takes away the fantasies that allow for the fabrication of all kinds of Frankensteinian monsters.

Senator MONDALE. I don't like your Amchitka example at all. [Laughter.] Were you here this morning when I read Dr. Kornberg's

statement? I think it reflected a view that we are just interfering with scientific schedules, and there are great risks to a public study.

Let me read it to you. This is Dr. Kornberg, one of the great men of medical research.

He told the committee:

The biochemist who deals with molecules cannot afford any time away from them. Today, I am not in the laboratory. I do not know what is going on at the bench. Tomorrow, I will be less able to cope with the identity and behavior of molecules. The more I am estranged from the laboratory, the less competent I am to advise you regarding special problems in this field.

He felt the committee was imposing upon his research time.

Is that a standard view in the research fields of medicine, that the money should arrive in hundreds, tens and ones, to be spent in the research field, but there should be no dialog or information passed back? Dr. NAJARIAN. No; that is not true.

Senator MONDALE. I think that is what he was telling us. He said he needed money, but "for crying out loud, don't ask me to come here and spend my time at hearings."

Dr. NAJARIAN. I think we will always have to have peer review, and that includes our lay peers as well, and I think we should be accountable for the research we do, and we should come to you, and when we appeal for more money for research, I think I can show you what we will do with that money, and I think it is important for us to come out with this kind of testimony to tell you what is going on, so you do know.

A lot of people in the United States still have the unfortunate idea that research is something that is very esoteric, something that is done on a bench that has nothing to do with disease, and why should we spend $1.4 billion on research just to support a bunch of people who are investigating different events of molecular structure, or enzymatic processes, or chain reactions if it has no direct clinical application?

Well, that kind of decision is made by people at the National Institutes of Health in their peer review study sections.

Senator MONDALE. Most of the same people favor this commission, and they are the very people who fight hardest for those researchers. Dr. NAJARIAN. Right. I don't look at this commission as restrictive. I think the fear that such a commission, and I think that as I read. Dr. Duval's testimony this was his fear, the rules would be set up and would be so restrictive that it would be impossible to continue in the research much as we see it today.

I have faith that this commission would not come up with that alternative.

Senator MONDALE. I have a feeling that medicine does not want to explain its case partly because they went through the period with Lister Hill where they were in a preferred status, like the FBI. I think we are at a point now where American medicine has to explain itself. I suspect very few people in this country are aware of the kidney situation that you referred to, unless they are a part of a family that suffered.

Yet, I think if they did know, there would be a far more adequate response than we have perceived.

Dr. NAJARIAN. As a practicing physician and surgeon. I feel the worst thing you can do with a patient is not explain what you are

doing, and by just sitting down and explaining what the patient has in the best terms that you can translate it to him and then tell him what operation that you are going to do and what is going to result and what you expect from it. I think it is a lack of information that the people resent. They feel like they are on the outside looking in, that we don't know what we are doing.

Skeletons will come up, we know that. On such a commission and looking into certain items such as medical research perhaps, this should be exposed.

I think what is going on, if the American public knows it and fully appreciates it and is cognizant of it, that they would accept it. Information is very important.

Senator MONDALE. One final point. I asked Dr. Duval whether in his opinion the medical schools today are providing adequate training, discussion and dialog in the social and economic implications of the professions. Do you feel that this is being given adequate treatment in medical schools?

Dr. NAJARIAN. Not in the way of a formal curriculum. We at the University of Minnesota recently had a series in the past 2 months at our medical staff conferences where we discussed the issues you are discussing today, human experimentation, because it must be discussed in this ad hoc way.

Whether it will develop into a formal course is hard to say.

Senator MONDALE. Don't you think your profession, and certainly it is true of my profession, suffers from failing to equip a highly skilled person with some social orientation? Isn't that increasingly important? We are in the midt of the most fundamental domestic debate concerning what we should do about medicine.

Yet, your national association-I am not sure if you are a member of the A.M.A.-comes up with the answer, "do as little as possible, stay out of our hair."

Even in response to this little proposal for a study commission, some members of the profession say: "We will take care of that. You take care of your business, we will take care of ours."

I think there is a tremendous amount of suspicion and fear about the public process as it relates to your profession.

Doesn't this reflect, among other things, a deficiency in training? I don't want to make social scientists out of every doctor, but it seems to me that we need Walter Heller kinds of physicians that may not be any good in a surgery room, but are good on the public policy questions that affect society.

Dr. NAJARIAN. We talked about this, but I think we are fortunate enough now that we are beginning to get a very socially involved group of students now, who went through their undergraduate curriculum, and are now in medical school, and this group is influencing our medical schools today.

They are asking us the social questions that we never discussed in medical school which, for the most part we were like a trade school. We teach them medicine, and this social awareness is increasing and through the students impetus, awareness of the social problems, is entering medical school discussed. I think this is a good thing, and it is occurring today.