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Thursday, September 12, 2002



Session 1: Toward a "Richer Bioethics" 4: Science and Society

Discussion of Hans Jonas' essay; "Philosophical Reflections on Experimenting with Human Subjects."

CHAIRMAN KASS: At this meeting we continue our discussion of two topics that have been afloat for several months, topics under the general rubric of regulation, topics under the general rubric of enhancement. Neither of those titles are strictly accurate, but you all know what I'm referring to.

As an introduction in a way to the further consideration of both of these topics, I have asked Council members to read for opening discussion Hans Jonas' classic paper on "Philosophical Reflections on Experimenting with Human Subjects."

There are a number of reasons why we thought that this is a good idea. First of all, the ethics of experimentation with human subjects is a critical moral point in which science and ethics intersect and in which one has a look at the relation between the scientific enterprise and the social values.

The goals of medical progress run up against our concern for the inviolability of the human person, and this is a place where society, usually with more-than-willing collaboration of scientists and physicians, erect restrictions, mostly procedural, on what scientists and physicians may freely do to human beings.

Second, those institutional arrangements and procedures for protecting human subjects are also instances of the attempt to put principles into practice. The Institutional Review Boards, which will be the subject of our discussion in the second session, are the places where we try to give effect to the moral concerns that society has, concerns that express themselves in procedures for recruiting subjects, for securing consent, and for monitoring results.

It is well to keep in mind, as we think about current efforts to reform the Institutional Review Boards, what the moral principles and what the human goods are that we are eager to protect and promote. So that the first session today will be largely philosophical; the second one will be largely institutional. It is important, I think, as we think about each, to keep the other in mind.

Third, it does seem to me that both with respect to the ethics of experimentation, but also with respect to all of the things that are of interest to this body, it is important that we try to become self-conscious about what exactly it is that we are trying to protect in these discussions. Of course, we are trying to protect human health and safety. We are trying to promote medical progress. We are interested, of course, in not violating people's freedom, as expressed in our concern for their consent.

But the question is, is that the whole story? Are there other things having to do with human dignity that are of importance here? And that consideration is relevant to the ethical aspects of all of our work, including, for example, things that might concern us in the area of using mood-altering or personality-altering drugs, the topic of our discussions this afternoon.

So it seems to me, for all of those reasons, a look at the kinds of issues raised by Hans Jonas in this essay seems an appropriate way to begin this meeting.

Let me introduce the discussion of the paper with at least one person's formulation of what I think he's about in this paper. It's a dense paper, and it's not the easiest thing to read and follow.

But let me at least state what I take to be the question at issue and something of the way in which Jonas tries to work his way to an answer to this question, and then throw it open for comment and discussion and see where we go.

I think the point of departure is on page 107 in the paper, where Jonas points out that human experimentation, for whatever purpose, is always also a responsible, non-experimental, definitive dealing with the human subject himself, and not even the noblest purpose of such experimentation would abrogate the obligations that this involves.

So he wants to put the conflict in these terms: On principle, it is felt human beings ought not to be dealt with as mere subjects. On the other hand, these dealings are increasingly urged upon us by considerations also appealing to principles that claim to override the objections of treating human beings in this way.

And he goes on to state what is for him the most serious difficulty, down toward the bottom of the page. "What is wrong with making a person an experimental subject is not so much that we make him thereby a means, which happens in social contexts of all kinds, as that we make him a thing, a passive thing merely to be acted on and passive not even for real action, but for token action whose token object he is. His being is reduced to that of a mere token or sample."

And he goes on to distinguish being conscripted as a subject for experiment and being conscripted as a soldier for war, while though you're still subject to someone else's orders and are still a means, nevertheless, are still acting in the way in which you understand yourself to be acting and as an agent.

Now the question of the paper is: What in the world could be of sufficient weight to justify treating human beings in this way? And I won't rehearse much of the analysis except to say that he doesn't find the answer sufficient in the notion of a social contract or even in the notion of health as a public good, because averting a disaster is different from promoting a good, and that medical research, though it falls in between, seems to be closer to the second than the first.

That, to be sure, society has adopted medical progress as its cause, but that the goals, however important they are for the professionals and urgent for the patients, nevertheless, medical progress is societally gratuitous, however noble, and in an interesting move, suggests that even when one goes out to appeal for consent and solicit volunteers for research, one is engaged in something that he calls semi-conscription — semi-conscription — in which in fact, and he doesn't elaborate on this, but the moral authority of the physicians, the moral authority of the people in the white coats, and the desire to please those upon whom one is dependent for help makes this not absolutely a free and innocent request, however well-meaning.

And the solution is somewhere to be found in his remarkable discussion where he says, the ideal would be the self-recruitment of scientists and where there would be the maximum motivation, the fullest understanding, the freest and most spontaneous decision, integration of this choice into one's overall life project, and, most important, the identification of the research subject with the purpose of the experimentation. It's that last idea which seems to have gotten lost, speaking now editorially, from the concern purely with consent, which is the granting of permission.

There are things that follow for research, the descending order of who's available and the like; no research on diseases not relevant to the patient. But it points to a kind of ethics of research that goes beyond just calculating benefits and harms, and even beyond merely giving permission and consenting, to something that seeks to do justice to the human person whom one is, nevertheless, inviting into this project as perhaps a co-partner in experimentation.

I wonder, I mean I don't think that's an unfair summary. There's lots of richnesses that have been left out, but I think I take it that's the shape of the discussion. I wonder to what extent we find this paper, written now almost 35 years ago — it was written in 1968, published in 1969 — whether this strikes us as sound and whether it offers an adequate ethical foundation for thinking about this subject.

Gil?

PROF. MEILAENDER: Let me just pick up really with what you noted in the paper. I mean, this paper, it is one of those rare papers that at least I think is sort of so profound that one would be glad to die having written it, kind of.

But I want to think about the problem that you highlighted there. I mean, the way he puts it, the difficulty with recruiting research subjects is that it, as it were, "thingafies" the person, which is a little like the concept of alienated labor actually, I think, in the sense that the person is used for an alien cause, not fully one's own, in which he or she is not fully invested, something like that.

Then the question is, how can you make that a human endeavor that fully dignifies the person? And the interesting thing to me, you mentioned it, is that the Holy Grail of consent doesn't seem to be a sufficient answer, as far as Jonas is concerned. Not that it's unimportant, of course. I mean, he doesn't want to suggest that we should ignore it, but it is interesting to ask why it is insufficient.

I think it is, as it were, too negative. It only protects the person against abuse, and that alone doesn't overcome the problem of alienation, the problem of not being fully invested in the undertaking. That is where you get the principle of identification that you pointed to.

If you say, "Why is that so important?", it is because this descending order that he sorts out is a way of trying to see to it that we at least first attempt to recruit those most fully able to identify with the project, which is probably almost the reverse of the way we actually go about doing it most of the time these days.

I think he even says it at one point: that, I mean, really it comes up in the discussion of why you wouldn't use patients as research subjects on something wholly unrelated to their disease. It is because you would be tempted to use them because they're handy in a way. What you are trying to avoid is simply using someone because he's handy, because then that person is in a certain sense alienated from it. Only that principle, which somehow goes beyond just the sort of negative understanding of consent as protection, can deal with the "thingafying" problem.

I think that's, even apart from the context of research, an interesting notion to puzzle over and contemplate a bit. It may relate to a whole variety of other issues, some of which we'll take up, because in a certain sense we might describe Jonas as asking the question: How do we think about the presence of the person in what we do in or to the body, or in what we take into the body?

Overcoming the "thingness" is a way of asking about what it means to be personally present and invested, not alienated from, the action that we undertake. I mean, I don't know how to make all the connections with other questions, and maybe they can't be made necessarily in advance entirely, but that's an issue that has kind of a larger resonance than just questions about experimentation, and in that sense it seems to me we can think about what Jonas says with respect to experimentation, but he's also driving toward something that cuts deeper and will involve or will be involved in lots of other questions.

Thank you.

CHAIRMAN KASS: Paul?

DR. MCHUGH: I can't add a lot to what you've said already, but I want to just give a couple of examples of how at all of our hospitals there are monuments to people who were scientists and who did contribute themselves to this work.

At Hopkins there's a large plaque to Jesse Lazear, who was one of Walter Reed's group in the yellow fever expeditions and died as an experimental subject. He was a young physician from Hopkins.

But perhaps the one that's not known and yet is perhaps the most distinguished human subject at Hopkins was William Halstead, the first surgeon, who in his early career, interested as he was in peripheral anesthesia, did experiments on himself and on others of his colleagues with cocaine as a peripheral anesthetic, ultimately opening up the whole sphere of peripheral anesthesia and dental anesthesia for our benefit, but in the process developing tremendous addiction of himself and on some of his young friends, several of whom died. Halstead was fundamentally carried as an addicted victim throughout the rest of his career by people like William Welch and William Osler.

So the one great advantage of the lineage that Jonas lays out here is that it's been done, and in the process of being done, does show us what can happen to an experimental subject in the most dramatic ways.

We honor them and the plaques for Lazear and our knowledge about William Halstead, of course, encourage us when we're asking other people and ourselves to contribute to similar research.

CHAIRMAN KASS: Janet?

DR. ROWLEY: I'd like to take a somewhat different approach to this, and I'm sure it is because, though I do not myself treat patients, my colleagues do, and the patients they treat are those with cancer and leukemia. Very often, these patients have tried all of the standard treatments for their disease, which seems to continue sort of relentlessly progressing. They are often the main protagonists for what is new: What can you give me that might even give me some remote chance of cure?

So the patient as sort of a partial victim, as is portrayed, I think may be true for some studies, is certainly true for some studies, but I think that it totally loses sight of those cases in which patients are desperate for any straw of hope, and they are more than anxious to participate in experiments that might give them some benefit, but also benefit patients in the future who have the same disease.

Certainly, for the treatment of childhood leukemia and a number of other cancers, the remarkable treatment successes we have now are built on those patients. I think that's totally lacking in this analysis.

CHAIRMAN KASS: Just to this point, Alfonso, go ahead.

DR. GÓMEZ-LOBO: It is my understanding that Hans Jonas does take that into account. For instance, on page 127 he says, "Introduction of an untried therapy into the treatment where the tried ones have failed" — where the tried ones have failed — "is not experimentation on the patient." In other words, he excludes that as an instance of experimentation, it seems to me.

CHAIRMAN KASS: Gil, to this?

PROF. MEILAENDER: Yes, right to this. I think we would want to ask a question, Janet, in the kind of circumstances you describe, whether the person is, to use the language I used before, fully invested in this undertaking as a research subject or as a desperate person hoping for a cure.

If the researcher is involved in what he or she thinks is research, and the person is invested in it not simply as a research subject but as a desperate person grasping at a last straw, the researcher's purposes may be somewhat alien from those of the subject. I mean, so we still have to think about that concern that Jonas has.

DR. ROWLEY: But is that really — I mean, I guess you are in territory where I'm on very weak grounds in terms of trying to think of the concepts, the nuances, and the dividing line between these. I'm not even sure that, for at least some of my colleagues in their work with untried, experimental therapies, but which have some rational basis — I mean, these aren't just picked off of somebody's shelf; they've all gone through both a fair number of trials in other animals, in animals before you approach patients — how to separate out the scientists' desire to learn and to see if this is going to be beneficial for the patient and his desire as a physician to do the best for that patient, that's a nuance I think I can't deal with.

PROF. MEILAENDER: Just really quickly, I mean I agree it is very difficult and probably can't be separated out and sorted out sometimes. All I wanted to point out was that nobody is handier than the desperate man.

Insofar as that's Jonas' concern, one would have to continue to worry about the intersection of those two sorts of roles, that's all.

DR. ROWLEY: Yes, but at the same time, if you're not desperate, you're not going to be willing to be a part of something that is experimental and untried, and things come with terrible toxicities, as we all know from any friend who has had cancer and been treated. So I don't know; it's a very gray area, I think.

CHAIRMAN KASS: Rebecca?

PROF. DRESSER: I was just going to comment that there's been some interesting research done actually by the University of Chicago physician researchers on Phase I oncology trials. I think the contemporary concept that people try to use in a formal way to go beyond just permission to be a study subject, it's informed and voluntary consent. I think in the abstract it sounds nice, but there are a lot of studies showing that many subjects don't have the kind of understanding that I certainly would like them to have.

In these Phase I trials, somebody looked at a number of trials and said they have about a 4 to 6 percent chance of directly benefiting the subject, and in terms of direct benefit, that doesn't necessarily mean extended life or even palliation. It's just tumor shrinkage. When they asked people who participate in these studies about possible benefit, many of them cling to that belief, that there's something in there that's going to help them as individuals.

Zeke Emanuel has written on this. So maybe he can comment. But this thing called the therapeutic misconception, where people who are in studies confuse what's going on to advance knowledge with their personal treatment, is a serious problem I think in Phase I trials, at least in actuality.

DR. ROWLEY: I think Chris Daugherty and others have certainly looked at this. See, I think, again, you have to put it in the context in which these studies are done. You're a physician; you treat patients, a very large proportion of whom are going to die. You are trying desperately to advance things. So it's true, you have a personal, psychological, vested interest in trying to come up with something miraculously which will change the situation, so you just don't go in and see one dying patient after another, which when my colleagues come off of the service, they're devastated emotionally for the trauma that they have experienced during the month that they've been on this intensive service.

So these are human activities carried out in very real, desperate circumstances. I think to dissociate the reality from, or to dissociate our dissection from the actual reality, makes this a somewhat unreal exercise.

CHAIRMAN KASS: Let me comment just briefly on that. I would underscore Alfonso's pointing to that place in the text where one acknowledges that desperate people in desperate situations, eager for cure, treated by people profoundly eager and willing to help them, can participate in things that are very risky with very uncertain promise of gain.

But even so, I guess the question is, in what way does one approach these people and what is it that one is — what of their humanity, in addition to their pain and suffering, is one also trying to respond to? I think that's partly the concern.

If one simply says, "These are the only subjects that are possibly available to advance our knowledge," however true and necessary that is as a condition for using them, the question is whether it's sufficient and whether one doesn't want to try in some kind of honest way to elicit their identification with the enterprise and not simply exploit their desperation.

It's not an objection to proceeding with that research, but the question is: How should they be regarded? How should they be treated? How should they be spoken to?

I think Jonas is suggesting that merely getting the consent form filled out as a permission to subject one's self to the risk is a formal procedure that might point to something else, but by itself isn't sufficient.

DR. ROWLEY: Let me just respond to that because this is a situation where I believe some of his perspectives, at least in some circumstances or some hospitals and teaching centers, has changed. It is certainly true over the last decades that our own informed consent sheet that a patient signs has gone from a simple, one-page form to about a five-page form that you would need a college education to understand. You are dealing with many patients who do not have that level of sophistication.

We have specially-trained nurses who talk with patients, try to explain all of this, but it is not simple. I'm not saying that medicine and physicians and individuals conducting this kind of research should not be even more attentive to patients, but I have to say, as an observer of what goes on in hematology/oncology at the University of Chicago, that I think that the physicians and the nurses bend over backwards to try to make sure that the patient understands the risks. Of course, many patients decide they don't want to do that, and there is no pressure on those patients to participate if they say, "I've been through two years of treatment and here I am, and I accept my fate and will deal with it."

But I am also certain that there are many places where this has not been emphasized as much as it is in some of the teaching hospitals where these concerns are probably much more applicable.

CHAIRMAN KASS: Thank you. Alfonso and then Mary Ann.

DR. GÓMEZ-LOBO: I'm going to step back a little bit in the discussion and try to go back to the basic philosophical framework.

Needless to say, I was delighted when I saw that Leon had included the article by Jonas. I had the good fortune of hearing Professor Jonas deliver a lecture at the University of Turin many years ago, and I was very, very impressed.

Now this is a wonderful paper because here we have someone whose main concerns were really abstract, philosophical thinking, and he's invited to think about the problem of experimenting on human subjects. It's admirable how he carefully sorts out all of the different issues, different possibilities, and at the same time I think is very careful to preserve the genuine interests of promotion of medical knowledge.

Now reading this article in the present times, it seems to me that there are two very important differences in the setting for the paper and the setting in which we find ourselves. Let me just go into two of them: difference in the facts and difference in the ethical approach.

With regard to the facts, of course, we have gone already through the Tuskegee scandal, et cetera, and we all know that there are these very serious efforts to overcome questions of consent, informed consent, that the people know exactly what they are going to be subjected to.

Now this assumes that we are talking about adults as the objects of research in the paper. However, as we know from our previous discussion of cloning, the big problem today is having human subjects, say, at the embryonic stage, who of course would be experimented upon without there being any chance of consent or something of that sort. So that creates a totally new situation, it seems to me.

Now the second difference I think is this: Again, I point back to our previous discussions. All of these trials that Jonas has in mind are, of course, therapeutic, and he insists that there be therapy in the benefit of the sick person herself, and that's what prompts this extension of saying, well, in certain cases, when some therapeutic means have failed, of course, one goes further for some kind of experimental treatment. From a moral point of view, it seems to me that's perfectly reasonable and permissible.

But from the stem cell research issues that we dealt with, there we are in a different situation. The human embryos are being destroyed, which of course is very different from what Jonas had in mind. In other words, there's intentional action there of a sort that he never even imagined, it seems to me, at least from this paper.

Now the second area where I think it is remarkable and what a different situation we find ourselves is, as I said, on the philosophical framework. It seems to me that Jonas takes clearly a Kantian approach. He has the philosopher Kant in the back of his mind, because he assumes that the first principle is that one should not reduce a human being to a thing or mere means, not just means but mere means, and he says, well, in order to violate this, we need very, very, very strong reasons and unusual circumstances, and he adds lots of qualifications. That's why he mentions war and mentions such other things.

Now if we think about our predicament today, it seems that the reverse holds: that what is socially accepted is the goal of promoting health and well-being, and it is the other principle that then needs justification. In other words, how can you justify not using, say, certain human organisms, if or since they are going to lead to all of these benefits? So it seems to me that that is extremely important in order to understand the direction of the moral debate that this article generates. Thank you.

CHAIRMAN KASS: Gil, to this or what? Well, if this is a direct response to Alfonso, yes; otherwise, there was a queue. Okay, Mary Ann, I'll just put you in.

PROF. GLENDON: Okay, this is a somewhat different subject, but this article was written in 1969. So much has happened, not only in terms of scientific and technical advances, but also changes in the culture, that I would be curious to know — and I think the other non-scientists would be curious to know — about whether there have been significant shifts in scientific opinion on some of the problem points that Jonas raises.

I mean, to be quite concrete, when you get to be a certain age and you go to a physician, and all of a sudden your physician, she looks like she's 14 years old, but she's probably 30, but, nevertheless, you can't help but wondering, what kind of culture has she picked up in medical school and what does she think about these issues that Jonas discussed in a certain way in 1969?

So I have three points that I would be curious to know whether anyone can enlighten us on, whether there have been significant shifts in scientific opinion. The first is where he mentions, as a somewhat peculiar point of view expressed at a conference, someone said, "Society cannot afford to discard the tissues of the hopelessly unconscious patient." And he raises the question, well, wait a minute, what does that say about who owns these tissues, if you talk in terms of discarding and salvaging?

That put me in mind of the discussion that goes on in my state, Massachusetts, which I realize is somewhat exceptional. We have organ donor cards that we may sign when we get our driver's licenses where we can give consent to have our organs taken, but there's some discussion about whether it wouldn't be better to just have a presumption that people's organs are available unless they sign a card that says they don't want their organs taken. It really reverses this presumption that Jonas is talking about in the area of experimentation. So that's one point about which I'm curious, whether there's some widely-shared view about whose decision this ought to be and what the presumptions ought to be.

Then, secondly, Jonas proposes very strongly that, not only as we have been saying there's an ideal subject for human experimentation, but that there is a category of subjects that are the least morally-justifiably subjects and those are the people who are least informed and least free. I wonder there whether we are seeing an increasing sense that actually that last category is the one that's most available because, well, as Gil said, because they are available.

Then, finally, the definition of death and the warning that he issues that there will be enormous pressure to alter the definition of death, so as to make more subjects available.

CHAIRMAN KASS: Does someone want to join directly these questions? Interestingly, Mary Ann, those are all things that would fit with Alfonso's comment earlier, where Alfonso suggested that his view of the cultural shift is that what is taken as the given is in a way the imperative or the necessity of medical progress or the saving of lives, and that the burden now falls on those who would object in the name of, say, the dignity of the person, something of that sort. I think it would take all three of your examples and make those specific instances of where his claim could be tested.

Does someone want to join, respond to Mary Ann? Paul?

DR. MCHUGH: Yes, I would like to respond to both Alfonso and Mary Ann, but perhaps to begin, to say that I think that there has been an important and, to some extent, a very useful cultural change that has occurred over the last 50 years and that relates a bit to what Jonas is saying but carries it another step.

You see, I agree with you that there's a Kantian thing here, but Jonas is calling for virtues, and virtues, Aristotle said, are tied to practices. The practices have been enhanced. What Dr. Rowley was saying is that we have seen wonderful things happen for our patients and for our world and for ourselves, and in that process a lot of us, patients, citizens, as well as physicians, have said, "We want to join these practices because they do call for virtues." Yes, virtues of the doctor/patient relationship, but also virtues of the subject, and that we want to be part of that.

We want to have this grace or virtue that we'll take part in this great advance that has occurred for our patients, our cancer patients, our endocrine patients, our heart patients, our hypertension patients. I mean these are wonderful things that have come forward, and lots of us have begun to think about how we could be part of that virtuous practice.

In that way, to some extent, we can go too far. I agree with you, we can go so far as to sweep by the people who don't understand what we're doing.

Now in my case in particular, after all, I am often talking about asking patients who are mentally disturbed to help take part, and that's a big problem that Jonas doesn't take into account here. He never mentions it and the like.

I also agree that there is besmirching of this virtue when grants, indirect costs, paying of subjects, and things of that sort come into play as well.

But at an important level, the culture has changed, and changed to advantages, because of the things that we have worked on. We should be talking about the virtues that are implied in the practice of this kind of research and avoiding the pitfalls that are here.

CHAIRMAN KASS: Is it your suggestion, Paul, that for the most part subjects that are recruited or volunteer for research are really entering in the spirit of identification? When you say that they want to join in this virtuous activity, that it's not just they give permission to run certain risks, but that they become, to use Paul Ramsey's phrase, co-partners in the experimentation?

DR. MCHUGH: I think that's far more true now than it was 50 years ago, as people have heard about the things which are potentials and which are happening. I must say they can be greatly taken advantage of. They can be abused. They can be given consent forms that, as Janet said, require a college education.

By the way, I think all IRBs now know that fact and submit the consent forms to these computer techniques that tell you what grade level you have to have to understand it, and show you that, you know, that you can have really impressive ideas that are at the third or fourth grade level. I mean, the Psalms are a good example of just how wonderful they can be, but that's a sideline.

But I do think that the issue of virtue and the acceptance that we have been not only great beneficiaries, but in a sense a common legion to attack the problems of illness in our society, in our world, is a broad theme in the citizenry, and that many patients come forward with that sense of being part of the process with the doctors.

For all the things that Jonas warns us about, I do think that Janet is onto something when she says, gee, you know, talk about this context, and this context is very broad on our society.

DR. ROWLEY: Can I intrude and just ask, Dan, you're probably, along with Paul, a physician who is involved in teaching medical students. If you think of how some of these issues were discussed when you first started as a faculty person and as they're discussed now, I would be very interested in briefly your comments or perspective on this issue. It's not fair for me to put you on the spot, but I think, of all the people besides Paul —

DR. FOSTER: You're always putting me on the spot.

DR. ROWLEY: — you really have practical experience and can comment.

DR. FOSTER: Well, the culture clearly has changed. When I started in academic medicine, you were either a basic laboratory investigator or you didn't work in a medical school, for example. I mean, there were very few clinical trials with humans which were going on. There were the heroic efforts in yellow fever, and so forth, where many physicians put themselves at risk.

You know, there were things that were going on, but clinical investigation is now a huge operation, both in the private sector for people who develop instruments and drugs, and so forth, but also in the context of teaching in the medical schools. So you find in all medical centers you have to have courses these days in understanding statistics, the consent, and all of those things.

Now do I think that the average — that that intrudes very much in the four years that they are medical students? I don't think so. I mean, I think that it's those sorts of issues about partnership and consent have been cast more in terms of individual patient care than they have in terms of the larger issue of how one gets consent, and so forth. So the culture has changed.

I think I want to say that the sort of conversation we're having today does not intrude on the real world. I mean, one of the dangers is, I mean these sort of sophistications that we're talking about here are not real-world problems.

I once heard somebody in a counseling session say, if you're worried about what people are thinking about you, don't worry, they ain't thinking about you. That's sort of the situation here.

The issue of literacy has to do with just reading of prescriptions, and so forth. I mean, you really do have to cast these things in terms of just consents that are understandable. Many times the corporations, if you're doing a trial, the lawyers put in these things that nobody can understand. Most of the time — we just had a grand rounds on this — you have to communicate the level of the fifth or sixth grade for most things, just the instructions on it. So this kind of conversation doesn't have anything.

So I don't think that — I mean, I think it's important to do because there have been terrible abuses of humans, and I think we need to focus on that. But I think that the effort — I mean, I thought this was a very scholarly paper, sort of ethereal in some sense for most average people. They wouldn't really understand it.

But there seems to be, and I certainly don't want to say — this is a warning — I don't want to go back to the discussions that we had about embryos, and so forth. I mean, we've already been through that in great detail. I think we ought to talk about the real practical problems that we have here.

There seems to be built in a view that I kind of hear that anything that you want to do in terms with humans, regardless of the virtue, is either dangerous or shouldn't be done. I mean, it's very carefully said here, well, okay, if it's a desperate situation, a patient is dying from cancer, you're worthy of trying to do something.

But to find out about a drug that just shrinks a tumor, in the first place, everybody I've taken care of in an experimental drug, if they have a tumor, that gives them at least a month or two of joy. I mean it does, and that's part of the foundation to build up — you know, it took 15 or 18 years to get Gleevec, or something like that. You know, you've got to get these small advances.

So I'm sort of rambling to say that I don't think that this enters into medical education in detail about consent until you get into start doing clinical trials.

As long as I'm here, I might make one other point. We began with talking about Kant and this issue of "thingifying" humans. That seems to be, for all the ethicists, sort of a holy grail about what we should do. But there is an element where in just clinical care the physician is more, or the scientist is more, than just an equal partner.

I want to illustrate that by a real-world case and then I'm through. I think that most people are happy to have somebody that they think they can trust to be working on things for their disease individually or for the long run.

The long-term editor of The New England Journal of Medicine, Franz Ingelfinger, as many of you know, was probably the most influential person during his lifetime about things. When he was a scientist, he had worked on esophageal cancer, and he got esophageal cancer.

He wrote an article in The New England Journal called, "Arrogance." That is the arrogance of the view that a physician should be not co-equal in terms of the care of the patient. Because he knew everybody in the world, he was besieged by: Should he have radiation first? Should he have surgery first? Not only that, he had kids who were physicians, and everybody — he said he was just torn to pieces.

Finally, somebody said to him, "Franz, what you need is a doctor." And he said, "I followed that advice and turned to my internist and was at ease that he would take care of me, and then I got back to my usual activities of editing this Journal and giving talks," and so forth and so on.

In other words, his learning, his plea was not for — I mean, he wouldn't consider himself a thing, but he certainly considered himself to be cared for by somebody that he trusted, and so forth.

So the bottom-line answer: The culture has changed, but it has changed mostly not in the undergraduate work in the medical school, but subsequently I think that there are very marked abuses that we have to limit. In the practical world, I think that consent is not simply a negative thing. I think it is a very important thing.

I am very worried continually about a subtle sense that medicine and medical science, which I consider to be a high and noble virtue, becomes cast in terms that it is automatically in some sense negative for those who are participating in it or those who do it. I would say that's not real world in this country. I think people who are sick want to do it.

If I had been prepared to say something, I would have said it a little better, but, anyway, I'm trying to answer your question.

DR. KRAUTHAMMER: Could I make a point on that, a response to that?

CHAIRMAN KASS: Charles.

DR. KRAUTHAMMER: Dan, I don't think that the issue is that we're casting advances or the noble or wonderful things that medicine has done as negative. I think what we're trying to do is to point out certain inherent difficulties and contradictions.

That is that when you do medical experimentation on humans, you necessarily introduce "thingness." That, in and of itself, is inevitable, and that, in and of itself, is a problem. It does not mean that you don't carry on that research, but it means that you have to be very careful and think about it.

We know what extremes of "thingness" can do. We saw it at Auschwitz. We saw it at Tuskegee. Those are the seminal examples which warn us that, however noble and beneficial medicine is and can be, the very nature of experimentation, which is to treat a person as a thing because we are studying it as a thing, is inherently dangerous. All that we're saying is, let's examine the dangers and ask what kinds of protections one has to introduce.

I was struck, incidentally, by the "thingness" of it. It always strikes me in blind experiments. We all read a few weeks ago about this new discovery that a certain kind of surgery for arthritic knees is useless, and it was discovered by having two sets of subjects, one-half of whom received sham knee surgery. It was shown that there was no difference in outcome between those who had the real and those who had the sham.

I always ask myself, how would you feel if you were the one who had that sham surgery? I mean, it's rather remarkable.

There's a more famous case, I think about 30 years ago, where that was done with heart disease. Also made a wonderful discovery of the uselessness of a certain kind of invasive surgery, right, with the mammary artery transplants which were useless. But it was discovered by doing sham surgeries on half of the patients, actually opening their chest, sewing it up, and doing nothing.

So we have here an inherent problem. That was a great discovery, that the mammary artery surgery was useless. On the other hand, we had real people who were wheeled in, anaesthetized, chest opened and closed, and nothing happened to them.

If I could make just one other point in response to what Paul had said about participation, being part of a great enterprise, I agree entirely that is the ideal. I think it's exemplified most dramatically when the physician himself engages and becomes a patient.

But consent is a separate issue, and it introduces itself here. There are three categories of patients in whom you can never really get true consent. That's children, the mentally disabled, and prisoners. Those are the classic cases.

Even if you exclude those cases, you have patients, adults, who are sentient and who are not in prison; you always have the questions of desperation and naivete. Those always contaminate, and I would contend that it is almost impossible to get a true consent.

Again, this doesn't mean that you don't engage in the therapy, in the experimentation, but it has to be a real caution.

DR. FOSTER: Let me just respond to that. I would be absolutely first in line to preclude the sort of issues that give interesting data but are totally unacceptable. I could probably spend a lot of time today, which I'm not going to do, giving you examples of things that have been done that I think are absolutely wrong. So count me as first in line for that.

I think that if we can bring some insight into that, but I just don't want to go over so far — I mean apart from the dialogue, which I think, as I say, is ethereal for the average person. I mean the illiteracy in this country may be as much as 23 percent. I mean in the West you can't talk like this.

I think everybody understands about protecting subjects and getting them to do that, but I don't think that most people are going to be involved in the Kantian thing. I would rather us concentrate on how we improve the process.

CHAIRMAN KASS: Bill May?

DR. MAY: On this question of recruitment and depths of identification, I suppose the most obvious analogy is recruiting for armed services. There used to be the practice, as we say, of shanghaiing people for service in the Navy, and so forth. Informed consent or signing on was a protection against dragooning people into military service.

But there's the next category of, if one especially went after those folks who would be highly motivated, let's say immigrants or convicts maybe destined for execution, those folks that you would hope could recoup significance for a life in danger of losing or rapidly losing the capacity to recoup or signify, and, look, you can't become a citizen of this country, but join the armed services and you'll find your way into citizenship, and so forth. So you're offering not the inevitability of it, but the possibility of it. Then the question is, what degree of possibility?

The final level that Hans Jonas is talking about, and that Gil highlighted for us, is a kind of patriotic investment. I mean people who join the Army and the Navy for reasons of patriotism. But what lies behind that, it's a conception of the country. I mean, if they are disposed to sacrifice, it's not simply because just out of nothing they're disposed to sacrifice, but they belong to something; they're participating in something that in a sense they're joining a history of sacrifice.

This was talked about in terms of some idealistic physicians who felt themselves belonging to a tradition of sacrifice that precedes them. That tradition may not be very alive amongst us now.

The problem is, the larger problem is, we live in a setting of a society where we do not think of the society itself as founded in sacrifice. Its origin was a deal where you surrender something and you get something, and then the terms of that deal is, what allows the State to do things? It is the fact that it gives you something. In order to be able to give you something, it, of course, has to stay alive. So a fundamental warrant granted to the State is its capacity to conscript if its survival is at issue, and that's where Hans Jonas takes that.

But there are, of course, other old traditions of the origin of the State where the State was founded not on a deal, 17th and 18th century, but is founded on sacrifice, the sacrifice of the gods or magnitude of investments on the part of individuals, and so forth.

There's an echo of that, I guess, in immigrant folks who weren't dragooned to come to this country, but whose parents made great sacrifices to bring them here. In a sense one belongs to a tradition of sacrifice, so that what you do is simply your mode of participating in it.

It seems to me that is what is largely lacking in the particulars of professions or the kind of warrants that we can present to people. So we have to suppress that speech. Hans Jonas gives us an illustration of that speech, almost mockingly, because you know it will chill people. They will not act, because the ordinary terms of relating through such an undertaking, such an enterprise, is signing on. Then the question is, what will I get out of it? That's understandable.

CHAIRMAN KASS: I have Rebecca and then Bill Hurlbut.

PROF. DRESSER: One interesting thing about that sham surgery study was that, as part of it, they made people write down, "I understand that I am going to go through surgery and they might not do anything to me." They lost a lot of people after they said, "Yes, I want to do this," but then they had to write this in their own words, and people said, a certain percentage said, "No thanks."

I think this paper is brilliant and timely, and it really forces us to step back from something that we accept so much as a society today, this idea that progress is not optional, but it's nearly mandatory and this kind of sense that we are in a war against disease and we must go forward with research.

So progress is almost mandatory, and progress of a certain sort, progress in the form of advancing knowledge to produce miracles or unknown effective treatments, as opposed to progress in providing measures that we have available today to more people, such as established health care and even more basic things, like decent housing and education, and so forth. So it's we must make progress and we must make progress in a certain way and not another way.

Then it becomes interesting, why do we see it this way? Why is our culture at that point? You know, I don't know; I think we've gotten more that way than we were when Jonas wrote partly because of the patient advocacy movement, which started with HIV/AIDS activists where they started presenting research not as something to be afraid of, but something that we will demand. "You must do research on our disease." Then women and other groups got involved in saying you must study women because we want to know whether to take an aspirin, and all this sort of health advice that's being given to men.

So research is seen as a benefit, and that view is really, I think, promoted through patient advocacy groups and also through journalism. I really think the way that research is reported on reinforces that image.

But I'm not sure if those are cause or effect. So I would be interested in hearing if anyone else has thoughts on that.

CHAIRMAN KASS: Bill and then Gil.

DR. HURLBUT: What interests me about this essay most strikingly is the way Jonas puts the ethical, foundational, central significance and progress as contingent upon the preservation of the ethical.

Central to the essay is a dignified and exalted view of human beings and a recognition that the ongoing existence of society and the progress of science depend on this view of humanity as the source of something that can't be legislated or enforced.

The progress — it seems to me in his essay he says it plainly — progress is not the highest concern, that progress flows forth out of a society where you preserve humanity's central core of individual dignity and its commitment to personal devotion, what he calls authenticity and spontaneity.

In an interesting way, this places the essay as a hinge-point between our previous six months and where we're heading next, because our disagreements and discussions at least hinge to a large extent in the first half of the year on the question of how to preserve this humanity that we're trying to promote, nourish, and heal.

The thing that strikes me about this essay so strongly is how Jonas acknowledges the central concern for all of the other benefits of society of the preservation of the crucial qualities at the core of humanity. In that sense, as we go forward now, we talk about enhancements. The issue is, how do we preserve this crucial, ethical quality within human beings, this central core on which all things depend, both meaningful individual existence and social cohesion?

He speaks of a sphere outside the sphere of social contract, of public rights and duties, of a trans-social upwelling of personal idealism, the noble of grace, not decree, and intangibles even of a religious order, and what Bill was saying of self-sacrifice.

It strikes me as an interesting place to start our discussions of where we are heading with our progress, that we need to preserve these qualities as central. Just to give a couple of his own words, he says, "The ethical dimension far exceeds that of the moral law and reaches into the sublime solitude of dedication and ultimate commitment, away from all reckoning and rule, and shored into the sphere of the holy."

And he says, "A society cannot prosper without this. It must draw on them, but not command them."

And then he goes on to say how this source is powerful and wells up from natural humanity. All we have to do is be sure not to preclude or quench it. He says, "We have laid down what must seem a forbidding rule to the number-hungry research industry" — in his essay, that is — "having faith in the transcendent potential of man. I do not fear that the source will ever fail a society that does not destroy it, and only such a one is worthy of the blessings of progress."

I found this a very striking essay for that because it called me back to that commitment to the central significance of the ethical in not just the individual, but the whole outplay of social process; that we need to be concerned not just with what we preempt, but what we promote as well and what we preserve, perhaps more centrally.

CHAIRMAN KASS: Thank you. Gil.

PROF. MEILAENDER: I want to go back to Mary Ann's comment quite a while ago and make my way from that to Dan's, in order to try to persuade Dan that this really is the real world here.

At least as long as some of your fellow human beings seated around here obstinately intend to talk about it, Dan, it's going to have a certain kind of reality. We're just going to keep beating you over the head with it.

DR. FOSTER: I wouldn't have been in this discussion if it was not for Janet. Okay?

(Laughter.)

PROF. MEILAENDER: It's her fault, that's right.

(Laughter.)

The interesting thing, in terms of the three kinds of issues that Mary Ann raised and just inquired sort of how things had or had not shifted in the roughly 30-year period, say, since Jonas wrote, is that in fact I think I'm right to say that a lot of people worried about those questions, and that the increasing attention to consent, you know, free and informed consent, the increasing kind of codification and requirement of consent was precisely designed in many cases to deal with some of those issues that you raise, and does deal with it in many ways. I mean this was Paul's sense that something good has happened.

The peculiar thing is, though, that I think if you took those three, you would see that they all remain quite contested areas actually. Indeed, for a while we thought consent solved the problem, and I think you would say that many aren't so sure that consent has solved the problem, partly for reasons Rebecca referred to in her comments.

See, that brings me back to the, to me, interesting thing about the Jonas article, is that you somehow have to dig a little deeper than just consent. Just a notion of consent won't turn out to satisfy us in terms of the sorts of issues, and the enormous amount of attention that's been paid to it in the past 30 years and real concern about those issues and progress in certain ways still doesn't turn out to solve it entirely.

That brings me to Dan's comment. I think part of what Jonas is getting at, and part of the reason for that, is this is not just a concern about researchers out there, Dan. We love them all, though they are, of course, subject to all the vices and temptations that the rest of humanity is.

The concern is not just that they might misuse their research subjects or their patients or those desperate people, or whatever. The concern is that we might being using the researchers as our instruments.

I mean, we do all, to some degree, live off of each other, of course. But we don't just want to live off other people. Insofar as we all benefit from what medical research does, we do need to think about whether what that really means is that some of us benefit by living what others have largely done.

What Jonas forces us to ask is, to what degree those people off whom we are living really thought of themselves as sharing with us in some kind of undertaking or to what degree we're simply living off them with nothing more? So it's really not just a question about what researchers are doing, though if their consciences bother them, you know, that's good and they should worry about it, but he is really getting at kind of what all of us do in benefiting from research.

I will say, I mean, if you go to a teaching hospital and you look around at the people who are there, it ought to lead you sometimes to worry about whether you are living off some other people who are very unlikely to have some sense of sharing in a joint venture.

So that's where I think Jonas ought to point us. If that's not a real-world problem, then I wouldn't know what an important real-world problem would be.

CHAIRMAN KASS: Dan?

DR. FOSTER: Just one quick comment: I mean, I think your concern about living off others is not limited to biomedical research. I would wonder about the stock market and everything else. I mean it seems to be sort of a systematic desire for a few to live off others.

I mean, I think that one cannot eliminate the human need or evil, or whatever you want to say, to live off others in that sense. I accept your comments, and I love bioethicists, too, even though they are often ethereal, as I say.

(Laughter.)

CHAIRMAN KASS: Alfonso?

DR. GÓMEZ-LOBO: Just a little clarification for Paul, if I may, on the question of virtues. But let me start from what Charles said because Charles — it happens to me very often — expresses with great clarity what I would have liked to express, but never managed to do.

What we are talking about here is a question of caution, of being very careful with what we're doing when there's research with human subjects. Now that can be expressed either in terms of respect for the dignity of persons, but it can also be expressed in terms of virtues.

One of the key and fundamental areas to deal in virtues is, of course, the virtue of justice. One could say the endeavor here is this: that in the overwhelming majority of cases there are no violations of justice, I presume, but we should be very careful in these very special cases that justice is being done. So I don't see it as mutually-exclusive. By the way, Kant does have a very strong theory of virtues as well.

A further remark is this: We hear in the paper and in Bill May's remark the constant parallel with conscription. I find it a little bit unsatisfactory myself because I'm not sure that all instances of conscription are morally justifiable. I think that a case can be made that in certain instances it's morally wrong to conscript young people.

Now the extreme case would be, of course, the conscription of young Austrians to fight for Hitler in World War II. Some young Austrians drew that conclusion, and they were duly shot, of course.

CHAIRMAN KASS: Paul, and then I'll have a comment, and we'll break.

DR. MCHUGH: I'm always in your debt, Alfonso, to explain to me these differences amongst the philosophers.

But I think we're all at least talking in similar ways about what we want to do as practitioners. I want to get away from this idea that it is ethereal, Dan — I have to speak as the psychiatrist here — that it's ethereal to work in a full and expanding consciousness. That's really what I want to do as a doctor, and I think that's what you want to do.

All of the activities that I do every day I want to have in full consciousness and appreciating my place in this community, because it's the community issue that I believe the virtues ultimately emerge in, in the practitioners who are fully conscious of what they're doing all the time and who are listening to people like Jonas and others about how they should think.

But I still want to come back to the idea that the full consciousness of a community does come in advance and does advance along with things which a community accomplishes. The tremendous accomplishments of things in medical science, along with, as Gil said, refinement of our research procedures, has been a tremendous uplift to what we can accomplish as members of a community, whether we are subjects or whether we are investigators.

I also agree that we haven't ever completely answered all of the issues that Mary Ann raised, because these are always vexed questions, and there's, to some extent, an asymptotic approach to the justices in them in which we can't be completely satisfied that we have an absolute forum.

Now Charles wonderfully explained that there are three groups of people in whom research is — well, he said it shouldn't be done: children, the mentally disturbed, and prisoners. I want to salute that. I want to get up and say, "Right, I'm all for that."

But then, gosh, wait a minute, I want at some time to be able to talk about why I might want to persuade people who have mental disturbances to work with me and to be pa

rt of this virtuous community, to take on the virtue of being an independent signer-on, as Jonas says, a commitment to this.

I'm also losing it a bit, but it was this idea that this is too ethereal. It is not ethereal, I think, to anyone who believes that he should, or she should, be acting in his practice in full and advancing consciousness of what is happening and finding the words that deal with the feelings that he has, or she has, when he asks patients and subjects to commit to being in part a "thing" in this work.

DR. KRAUTHAMMER: Leon, I must make a clarification here. I didn't say that you should never experiment on them. I simply said that you could inherently never have informed consent —

DR. MCHUGH: Right.

DR. KRAUTHAMMER: — which is why you have a difficult problem of delegated or implied consent or proxy consent, and there are all kinds of regulations which, in fact, in a previous life, a quarter of a century ago, as a psychiatrist working in the Carter Administration, I worked on those regulations.

But these are three categories of people which make the problem of informed consent very, very clear, since it is impossible to get that kind of consent out of them. So you have to devise a mechanism to get around it. It is not as if you can never have experimentation. I would never argue that you can't have experimentation on children.

DR. MCHUGH: Yes, fine, thanks. Thanks, Charles.

I think my point continues just in the same way, that that kind of discussion, that kind of interaction, that kind of explanation of and misunderstanding makes my life and my practice more enriched. That is the whole reason why I want to do it.

CHAIRMAN KASS: Okay, we're coming up on break. Let me make a couple of comments. A lot of people stirred me up, but I will just be very, very brief.

It does seem to me that, however abstract the text is and however philosophical, and, therefore, seemingly remote from everyday practice the article is, and certainly can be a big jump from this to talk about the regulations and the IRBs, it does behoove us, I think, to think very hard about what it is we are trying to protect and preserve in all of these arrangements with our patients, not just as experimental subjects, mind you, but in all the human encounters.

If it turns out that the attempt to protect these things produces documents of five pages long, which one needs not just a college education, but a legal education, to understand, and it is in fact the lawyers who have seen to it that it looks like that because they're interested primarily in protecting the institution, and not necessarily protecting the things that we are interested in, then it seems to me one might have gone off the road.

It ought to be possible to explain to someone with a fifth grade education but with a human heart what it is that one is trying to do here in the same way as one could explain to them what one is trying to do in all other kinds of human relations.

Jonas is, I think, trying to get at something which lies beneath and ought to inform the procedures and the human interactions, and I think not just in the experimentation, in the area of human experimentation, using human subjects for research.

It seems to me both Gil and Bill Hurlbut in their own way called attention to the fact that the principles that are operative here will be relevant for the discussions that we are going to have this afternoon, and they ought to at least be in our mind — I'm not sure we've clarified them yet — but ought to be in our mind when one thinks about trying to adjust the procedures that are, in fact, meant not just to encourage the research to go forward, which we all want, but in fact to protect, whether it's human dignity or human virtue or the sense of community or the notion of paying one's price for the benefits of having a community and the sacrificial norm that Bill spoke about.

Those abstract things are, nevertheless, tacitly present, and we probably, at least the presupposition of this conversation is that we would be better off making them not just tacitly present, but, as Paul says, matters of consciousness, when we try to fiddle with various things.

We have gone over a few minutes, not too bad. Why don't we reconvene at 10 minutes before the hour, and Dr. Emanuel will join us?

(Whereupon, the foregoing matter went off the record at 10:33 a.m. and went back on the record at 10:52 a.m.)


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