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Meeting Transcript
April 26, 2002

Hilton, Crystal City
2399 Jefferson Davis Highway
Arlington, VA 22202

April 26, 2002


Leon R. Kass, M.D., Ph.D., Chairman
American Enterprise Institute

Rebecca S. Dresser, J.D.
Washington University School of Law

Elizabeth H. Blackburn, Ph.D.
University of California, San Francisco

Daniel W. Foster, M.D.
University of Texas, Southwestern Medical School

Francis Fukuyama, Ph.D.
Johns Hopkins University

Michael S. Gazzaniga, Ph.D.
Dartmouth College

Robert P. George, D.Phil., J.D.
Princeton University

Mary Ann Glendon, J.D., L.L.M
Harvard University

Alfonso Gómez-Lobo, Dr. phil.
Georgetown University

William B. Hurlbut, M.D.
Stanford University

Charles Krauthammer, M.D.
Syndicated Columnist

William F. May, Ph.D.
Southern Methodist University

Paul McHugh, M.D.
Johns Hopkins University School of Medicine

Gilbert C. Meilaender, Ph.D.
Valparaiso University

Janet D. Rowley, M.D., D.Sc.
The University of Chicago

Michael J. Sandel, D.Phil.
Harvard University

James Q. Wilson, Ph.D.
University of California, Los Angeles


Session 5: Enhancement 1: Therapy vs. Enhancement
Session 6: Regulation 1: Regulatory Approaches to New Biotechnologies
Session 7: Public Comments


CHAIRMAN KASS: Why don't we get started.

Today we are shifting gears somewhat to take up for the first time two new topics — the question of enhancement versus therapy and questions of regulation — both sessions undertaken as pilot conversations to see whether there is something in either or both of these topics that would warrant serious attention by the Council in the future.

There's a lot to say about this. I will say just a little at this stage, and really want to see how the conversation goes. First, there is a sense in which the two things we'll be talking about today could be seen as not discontinuous with our interest in cloning, which, although we've spent the better part of our time wrestling with the question of cloning for biomedical research, the major interest in this topic to begin with is cloning for producing children.

And one of the reasons why it is of concern is at least some of us see it as the first instance of possible multiple ways in which one generation could exercise genetic selection over the next with a view to its improvement. And also, the discussion we will have about possible regulation of biomedical technologies is one way into the public policy questions of which we also — we have yet to take up in an explicit way with respect to the question of cloning.

In the cloning case, the public policy option at least on the table is one of legislative prohibition, but the public policy options open to us in this field are much broader, and we have yet to have that broader conversation which we will do today.

On the other hand, if there is continuity between the subjects of today there is discontinuity, if not in the subject matter at least in our approach to it. Curiously to at least this observer, the subject of cloning which first became a hot topic several decades ago in the context of possible eugenic possibilities of producing superior human beings or replicating them now is taken up primarily over the — as a matter of a new and benign treatment for infertility in certain cases.

When we take up the question of the possible implications of going down the road of cloning for biomedical research, we think primarily of the benignness of the ends of medical therapy and bracket to the side other possible uses that might be made of the powers that are available here.

And when we take up the ethical questions there, the primary question has been about the ethics of the means, which is to say, what happens to the embryos that are produced in this — in the research?

We have adopted generally a case-by-case approach in thinking about these matters. It's perfectly understandable because these technologies come to us one by one. We are reluctant, at least some of us are reluctant, to look too far ahead, partly because it's uncertain where things are going, partly because we're practical-minded and don't want to engage in speculation where there are clear practical issues before us.

And I sense that at least some members of the panel are unwilling to allow — unwilling is too strong — are nervous of allowing fears about future shock to imperil the present science. And yet I want to suggest that the reason that maybe not — the reason that we are here not necessarily as individuals, but the reason why the public is concerned about the kinds of questions that give rise to the field of bioethics is — and, therefore, too, in a sense, the existence of a panel like this, is a real concern about where biotechnology might be taking us in the large.

And as Charles said at a previous meeting, his concern is less with where these powers come from, but the uses to which they might be put. Not only are we concerned, if we are concerned ethically, about the harm to newborn children made of cloning, or about the embryos that might be lost in the process, but about what we might do to ourselves and to others when we start to use the powers biotechnology makes available for purposes beyond the treatment of individuals with specific diseases and disabilities.

The promise — I think the concern that is on people's minds is if you put it in the extreme form, the promise, if you like it, or the horror of some kind of super or trans or post-human future, where the prospects of — in the mouth of the proponents — some kind of superhumanization or improvement of the race or dehumanization if you worry about the consequences is at issue.

And I think, as it's been said before in the meetings, we somehow recognize whichever side we are on the question of cloning for research that there are powers available here and ideas that are afloat here that will affect what it means to be a human being, not only from the technologies but also from the underlying ideas.

And as it happens, this morning's Washington Post, in the Style section, which indicates where these things get taken up, there's a story on the next generation where bio-cyborg, etcetera, man is introduced, and it shows you what's happening. I mean, I have never, in 25 years of being in a classroom, brought a newspaper — bring some reference of, you know, Rousseau or Tolstoy or something like that.

But here let me just say here are questions put before us about the possibilities of changing our species, not because anybody is heading deliberately to do it. But what would parents do when offered something that would increase their child's SAT scores by 200 points? And I don't think he has in mind genetic engineering, but certain pharmacological things of the sort we might talk about.

What will athletes do when they are encouraged by extreme big-buck leagues to have medical pit crews? What will fat people do when offered an implant that will monitor and alter their metabolism? What will the military do when it can overcome the need for sleep? What will the aging do when offered memory enhancers? What will babyboomers do when it becomes obvious that Botox and Viagra are just the tip of the iceberg for the pharmagenetic sex-appeal industry?

Supposing technology allows us to transcend seemingly impossible barriers, not only for ourselves but exponentially for our children? What price does trans-human wisdom and power demand?

Now, hyperbolic, journalistic we can I think easily detach ourselves from this if we would like. But I would suggest that it is I think incumbent on the Council at least to explore the possibility that there is something here worthy of our attention. And the question comes to us usually in this form. What should we think about, and what should we do about the uses of these powers when they go beyond the accepted medical norms of healing disease and relieving suffering?

And what, if anything, could be done about this, even assuming that we would like to? Hence, the question about enhancement. Hence, the question about regulation. I think this is a natural context for this.

The question about the so-called brave, new world problem usually comes to us in the somewhat tepid form of the distinction between enhancement and therapy. Enhancement is a rather sanitized name perhaps for what in the mouths of some people is a much more grandiose hope and aspiration.

And I think Council members have been sent a very interesting new book by Gregory Stock called Redesigning Humanity. Stock is a physician, scientist, and futurologist of sorts. He at least has the courage to lay out what he thinks is coming for our consideration.

You don't have to like his point of view on it, but I think it's a useful thing to think about. It may be excessive. It may be not. But I'd be interested in your reaction.

For this first session, we're going to have a preliminary go-around on this topic of enhancement, to ask ourselves whether this is a useful distinction therapy versus enhancement, to see whether it matters to us, and then to try to do so in the light of some concrete cases that have been put forth as possible exemplars for consideration of this topic.

The staff has prepared a working paper that you have in your briefing books that, in fact, explores some of the ambiguities in the terms, makes an argument as to why it still should matter to us whether this is the right term or not, and then gives several examples.

And I would just simply like to open the floor for reaction to the working paper and to this topic.

Paul? Paul McHugh?

DR. MCHUGH: Yes. Well, you asked me if I wouldn't try to kick off something. First of all, in the reaction to the working paper, I like the working paper. It does develop ideas sufficiently far for us to carry on a coherent conversation. It makes very useful distinctions in relationship to certain aspects of therapy and enhancement.

What I miss from it and from the other articles here is any understanding or any clear description of just the several domains of therapy. Okay? Before enhancement.

And you said, for example, Leon, to begin that therapies can be construed easily if we think of healing disease and relieving suffering. But the issue of what you call disorder that comes to a doctor and particularly, by the way, to a psychiatrist can have several distinct realms of enterprise and distinct issues in relationship to disorder and health.

And if you just looked at them in a simple order — I don't want to lecture you too much on this — but I do think the important thing before we talk about enhancement is we do know in what ways therapy — appropriate therapy is now available and is used by doctors and everyone accepts these as therapies, even as they begin to merge on the issue of enhancement.

First of all, a therapy for a symptom or sign that can be tied to a structural or functional abnormality of the body is therapy flat out. It is talking about your disease issue. And that would be the therapies, for example, for pain management or, as was nicely shown in the working paper on dwarfism, a growth disorder in which you can show that the person's sign, namely a lack of growth, is due to a lack of hormone. And the replacement of that hormone is an appropriate treatment.

Now, by the way, with further advances in medical science, more and more appropriate disorders that have a pathophysiological basis related to a structural or functional abnormality will come forward, we'll find more of them. But those are not the only therapies that we work on.

For example, there is an appropriate therapy for motivational drives that are strong enough to overwhelm resistance and produce destructive behavior. For example, gastric stapling for the obese and overeating. We think of that as an appropriate treatment now, protecting people from the obesity that brings it — brings with it other disorders.

But there is appropriate treatment for the sleep disorders like narcolepsy. And for those induced disorders such as nicotine habit, we use Nicorette gum. And even with the paraphiliac disorders we are now using Lupron and other things to reduce the sexual drive. And we see them as appropriate therapies.

The third area is therapy for the dispositional traits that hinder adaptation. And here we begin perhaps to think in terms where enhancement comes into play. But there is no question that Ritalin for the condition attention deficit disorder has been useful. And we are still exploring the place of Prozac in relationship to certain neurotic tendencies and disorders.

And although my friend Peter Kramer has talked about cosmetic pharmacotherapy, there probably are psychological dispositions for which an appropriate treatment is available. After all, by the way — and it might not be a therapy — but all of us use — many of us use a compound that helps us to be a little bit more talkative at parties. And one of them was used on me last night, and I was probably a little too talkative.


And a little coffee to wake up.

But to go from dispositions — to go from diseases to motivate to drives to dispositions, and then there are therapies for intense human emotional reactions to life stresses. And here you might think in terms of enhancement, but antidepressants used for people in the throes of serious and deep grief and even sometimes sedatives for life tensions that are occasionally abused, but can be justified in some patients.

It's after that that you come to the cosmetic and health therapies — cosmetic and health therapies, again, that we wouldn't — that begin to border on enhancement but, gee, we wouldn't want to do without them for appropriate treatment. I mean, after all, orthodontia is an appropriate cosmetic therapy, but it also has health benefits. Facial, bodily cosmetic surgery, again, you might wonder about them, but encouraging face lifts or encouraging cosmetic facial surgery to help people I think is not simply enhancement.

Viagra now — it's got a bad press, but it is a cosmetic or a health therapy that I think enhances life circumstances in many cases. And then we come to the therapies on demands that are pure enhancements. I want to be taller, stronger, faster, brighter, and it's there that we really can see that the enhancement issue comes into play.

I've had two encounters with both — with those things. One of them was a personal one when I was a small person in Massachusetts, and somebody suggested to my father I should have human growth hormone. And, fortunately, my father said no. And if he had said yes, at that time those — those hormones carried with them in many cases Creutzfeldt-Jakob disorder, as you know, afflicting people who later — who grew but — and my father said he was small and I was going to be small, and it would be all right.


And now I talk with you, with the group, is, as you know, there are — and these are — these would be enhancement issues, because I was not outside of the envelope that Richard put nicely together.

The other one is that with ADHD or the attention deficit disorder issue being clear amongst young people, there are — amongst the intensely interested young people, interested in being sure that their SAT scores are high, there are in a number of private schools minor, and sometimes rather major, epidemics in Ritalin use as the Ritalin gets shared around. And I've had several patients who have developed addictions to the drug.

So my point only is that if we're going to talk about enhancement let us be very sure that we know what therapy is and just wrapping it up with the idea that there is — that therapy is for diseases and everything else would be enhancement might make — might close off opportunities to see just what doctors do for benefits of patients.

CHAIRMAN KASS: Thank you very much.

Mary Ann, please.

PROF. GLENDON: I do think it's very important to discuss this aspect of the problem, and I would say not just for the future but right now in our current report. And I thought the paper was wonderful, but there are two dimensions that I hope we would add — demographic and economic. Let me explain what I mean.

I think that we need to, for the purpose of understanding what is likely to happen in the near future in this area, we need to talk about the aging of the baby boom generation and the very likely increased demand for services that are more on the enhancing end than on the therapeutic end.

And on the economic side, I can't help thinking yesterday and today about a conference I attended two weeks ago on globalization and poverty and wondering how these conversations would sound to somebody from a poor developing country, and especially in the area that we take up this morning.

It seems to me that if someone were here from a part of the world where many people don't live long enough to have expensive diseases they might truly be astonished at — and here's where I'm getting into the economic dimension. I don't know exactly how we build this up or whether there's existing research, but I know in our first meeting Dr. Foster and Dr. Dresser both raised this question about how we are allocating resources, who benefits, and if you view our question globally those questions become very acute indeed.

Enhancement for cosmetic purposes, treatment of the very expensive diseases of old age, in a world where many people do not live long enough to either require the former or the latter.

Oh, one other thing is I do think somewhere in our report we ought to have some information about what Dr. Foster raised in our first meeting. Who benefits from the various technologies? Who is investing in them? Just a picture of the whole economic background would be very helpful.

CHAIRMAN KASS: Bill May, Janet, Charles.

DR. MAY: Before the era of pharmacological interventions, the topic of enhancement came up in the thought of that cheerful optimistic Norman Vincent Peale and the power of positive thinking. And a friend of mine wondered what it would be like to see a pole-vaulting contest with two positive thinkers on opposite sides competing with one another. You could never bring the meet to an end.

One thing that doesn't receive as much emphasis but that is there on the margins is the whole question of enhancement in the form of life-extending technologies. I think one faces a very difficult issue when it comes to the issue of the choice of means to knock out adventitious disease and death on the one hand, and the use of some means towards the end of life-extending technologies, to move towards 110, 120, 140 years.

And one may have one view on the question of cloning for biomedical research if one is talking about adventitious disease and death, but quite another view if you're talking about the organization of resources and the mobilization of nascent human life towards the end of life-extending technologies. And it is this dimension of the problem of enhancement that I think has to be part of the discussion.

CHAIRMAN KASS: You mean changing the maximum life span is —

DR. MAY: That's right.


DR. MAY: That's right.

CHAIRMAN KASS: Janet, please.

DR. ROWLEY: Well, I think we should really take a rather cautious view of how we extend our discussions in this area. It's true that many individuals, particularly those with resources, can already take advantage of whatever they feel science or other modalities have to enhance aspects of their life. And I think that this is really a matter for individuals to solve for themselves.

I notice that the examples that are included in working paper 7 — none of them involve embryos. So they're all, at least as far as I could see when I read them —

CHAIRMAN KASS: Deliberately.

DR. ROWLEY: Okay. So this is — that's fine.


DR. ROWLEY: But then if one is — because it seems to me that the major concern or a major concern that has been expressed is how we will be able to manipulate DNA such that we will enhance the zygote to develop into a smarter, stronger, to quote Paul, faster human being.

And it's in that area — and I think I mentioned this in the first meeting — all of these traits involve anywhere from 50 to 100 to 200 individual genes working together in a highly regulated, concerted fashion to lead to somebody who is very smart or very tall, or whatever.

We don't have a clue about that. We probably are not going to have a clue about those interactions, both positive and negative, for another 10 or 20 years. So I think that enhancement, in terms of somebody — for reproductive cloning is so far down the line that, again, that's not an issue that we need to take up.

CHAIRMAN KASS: Let me say there has been talk about our report. This is not — this discussion about enhancement is not for the cloning project. I mean, this is question — one of the nice things about this question is that it's not tied to any particular technique, but it is a kind of question that cuts across the board and enables us to ask, how do we begin to think about the uses of powers that go beyond therapy, however broadly we finally decide we should define therapy? What norms and standards should guide us?

And I think Janet's point is very well taken. My own suspicion is that this fine-tuning of the higher human powers through genetic intervention is mostly talk, and certainly talk for a long time. But pharmacological things, things based upon coming trends in neural science, or the use of — and the Olympic Committee is already quite concerned about blood doping the muscle mass of mice.

Using just injection of — using DNA vectors to — in mice has increased their muscle mass some threefold. And the Olympic Committee is already very concerned about the uses of EPO to change performance — in effect, the whole character of the Olympics.

So I think we should — if we are going to take this up, if we take it up, we should be very careful to use examples that are here, plausible, and not simply leap to the things that are far-fetched. I think that's a caution very, very well taken.

I have Charles, Gil, and Elizabeth. Was it on this point, Elizabeth? Because I don't —

DR. BLACKBURN: A very small point.


DR. BLACKBURN: You said DNA vectors. And I thought since we are in a large group of people with different backgrounds we should just define that. It does not mean introducing DNA into the cells or the genome of people, but simply the DNA is used to make the product that you are talking about.


DR. BLACKBURN: I'm not sure if that was clear to everybody. I thought that it was worth clarifying that technical terminology.

CHAIRMAN KASS: Thank you. I lost my place. Charles and then Gil, Michael Sandel, and Dan.

DR. KRAUTHAMMER: It was deeply refreshing to go a half hour without hearing the word "embryo."


But that's over now.


I agree with you that we ought to concentrate on the here and now, and that means one-shot enhancement versus germ line enhancement. But I'm not sure that one-shot enhancement — I mean, the kinds of things that Dr. McHugh was talking about, are that much unrelated to the age-old enhancement of alcohol.

I mean, we have a paradigm for dealing with enhancement. It's not exactly a new problem. It's got new dimensions. I think what is new is the prospect it could be a decade or two or more away of — germ line enhancement — of changing us permanently. And as a Commission with a wide mandate, I'd like — I'd hope that we could discuss that also. We probably would be the first to think about it officially. We might contribute to people's thinking about it when it becomes more imminent.

And one of the reasons it's important, as Professor Glendon mentioned, there is a question of economics. There's a deep question of, as opposed to international inequality, of national inequality. If we are going to have permanent enhancements of a similar kind to germ line enhancements, it is overwhelmingly likely that it'll be the rich and that those well-positioned who will have access, and what that does is it changes a society with shifting inequalities to a society of permanent inequalities.

And that I think is a deep social issue which will really challenge us in the future. And even though it is in the future, I think it's worth us thinking about now as a way to contribute to people thinking about it when it actually becomes imminent.

CHAIRMAN KASS: Thanks, Charles.

Gil Meilaender?

PROF. MEILAENDER: Yes. I just wanted to think a little bit about where Paul started us, because I really do think if we're going to try to say anything about this, or even just talk about it, it's very puzzling.

If we start at the furthermost reaches of Paul's set of possibilities — I mean, people don't just want to — they don't just say they want to be taller, stronger, brighter. I want to be those things because I'm not happy right now. You know? I'm just not happy with my place in the world. Or maybe if I have taken a philosophy course, I'm feeling alienated even.

So the — if we're not able to make some kind of therapy enhancement distinction, we're not going to know or we're not going to have any sense of kind of what it would be appropriate for a doctor to decline to do, what it would be appropriate to think that somebody — some third party should fund, what it would be appropriate to regulate or not regulate.

And, I mean, Paul presented a series of steps, but I don't think there's any reason to think that what I counted as number 6 in it, you know, has thus far been demonstrated to be enhancement as opposed to therapy.

Now, I think it is, in fact, but one needs an argument more clearly spelled out. And even going farther up, you know, the emotional reactions to life stresses, well, there are a lot of religious thinkers who think that life is always stressful, and that it's not actually wrong to feel alienated in the universe. After all, one needs a certain kind of answers to those questions.

That's not necessarily a medical problem. That might be really keen insight into the nature of things.

So this is just — I mean, this is not to provide an answer but to say that I don't think there is any progress to be made in thinking about the question if somehow or other we don't really clarify that issue, not just talk about it but actually try to clarify for ourselves what it is.

CHAIRMAN KASS: Could I — no, let me hold back. We'll come back to it. Let's go in queue. Michael Sandel and then Dan, Frank, and Rebecca. That's what I have.

PROF. SANDEL: I do think we should take up the topic, and I think we need to address the questions that Gil and others have raised. We have to — apart from deciding where the line is between legitimate therapy and enhancement, and in the course of drawing that line, we'll have to press ourselves, demand of ourselves, that we try to articulate what human goods are at stake in drawing a line, whether for moral or regulatory purposes.

In the case of — and I think that we can do that. I suspect — and this is just initial speculation — that the objections that we will find ourselves articulating to enhancement, whether of the one-shot or of the germ line kind, will have some close kinship with the best reasons to worry about reproductive cloning, which is that in both cases the morally troubling feature is a kind of hubris and a picture — a world picture in which we, as human beings, aspire to mastery or sovereignty or control — ultimate control — over nature and ourselves such that we come to be and to see ourselves as self-creating beings who can make ourselves over according to our desires.

I think that's what's troubling about reproductive cloning because it's cloning for a child of a certain kind, according to our own design and ambition. And I think that's ultimately the moral part of the objection to enhancement.

And in order to draw the distinction, even if that's the underlying moral worry, we are going to have to try to work out some account of what normal human flourishing is, or health, and that might be that account which isn't an easy matter to articulate. That kind of account would have to provide reasons to restrain the drive to self-mastery and self-perfection that may underlie — may animate the drive to enhancement and perfection, and that we would want to reign in.

I would also — so I think that's the fundamental moral issue that we're going to — and I think we should try to take it up, and others may have different ways of accounting for what troubles us about enhancement. But I would just also want to add support to Mary Ann's proposal that we include in these discussions the economic dimension.

Now, there is a certain paradox in having these two discussions, because on the one hand we're saying these various techniques of enhancement are deeply dehumanizing properly understood. And then, with another part of ourselves we say, and, by the way, we also worry that these dehumanizing technologies will only be available to the rich, and that's unfair.


So I think there is that paradox. But I don't think the fact that it's paradoxical should lead us to shrink from either part of that discussion, because I think there is something troubling on both poles of that paradox.

DR. KRAUTHAMMER: Ice cream is equally dehumanizing, but everybody wants it.

CHAIRMAN KASS: Please, Janet, a quick point.

DR. ROWLEY: This is just a quick response to Michael, because one of the nice things about Paul's discussion was that he emphasized that this is really a continuum of things about which there would be almost no question to things that we all sort of laugh at and hope that we don't have such a shallow view of ourselves and our place in the universe.

But, you see, Michael continually used the word "line," that there is a line over which you go. There is no line in my view, and the line is going to depend — for each individual case it will be different and the circumstances of those cases. So to deal with this discussion as though there is an absolute answer, which will be applicable across all of these complex situations, I think is not correct.

CHAIRMAN KASS: Well, I'll sit back.


That's the trouble with conversation. You really want to continue it, but there's a queue. Dan?

DR. FOSTER: I only want to make one — by the way, I agree with the issues of justice and the other things that have been said, and I certainly think — and I've already told Leon, I think we clearly have to discuss the issue of germ line therapy.

And, by the way, even when you do somatic gene therapy, it's now clear that there's a danger of leak into the gonads. I mean, for the genes that you put into the muscle, there's a clear-cut risk of overflow into the germ cells. So we have to be careful about that.

I only wanted to say in terms of life enhancement and extension of life that — particularly extension of life that Bill spoke about, we know pretty well already how one can extend healthy life from Drosophila through — not absolutely proven in humans, but indirectly, and that is to undereat.

There is no doubt — it was first shown in rats by Donald Massoro 25 years ago at the NIH, that if you semi-starve rats that you increase their lives 20 to 30 — now, if you starve a fruit fly, it's very interesting. This was done and people didn't understand why the flies were living for a long time. Not only did they live, but they were reproductive late into life. They continued to be able to reproduce.

And the key gene involved with that — these gene people always give these cute names to them — it's called INDY. I'm Not Dead Yet. That's the INDY gene —


— in the fly. You know, it's just like Tin Man gene in heart development. The Tin Man had no heart, and if this gene is mutated you don't get a heart, you know, so they — so there are things that we can do without any biotechnology or anything else just by healthy things that would allow us presumably to live long. We don't know whether the dementia would be impaired or things of that sort.

You have to be careful, because I get challenged about this sometimes. If you measure the body mass index, which is what everybody uses for obesity and weight, it's just the weight adjusted for height. And a normal body mass index is 25, and obesity is at 27 in this country, 30 in the world. It's a J-shaped curve of excess mortality.

So, in other words, as you go above — as you get more and more obese, then it's a logarithmic increase in deaths from everything from colon cancer to diabetes, and so forth. But it's a J-shaped curve, so if you're BMI is very low, that you have an excess mortality as well. Those are sick people. Those are people with restricting anorexia nervosa, where you have sudden death, or cancer, and so forth. So don't be misled by that J-shaped curve. That's a pathologic — the short curve on that is pathologic.

So my point is that there are an awful lot of things that we could do — we can do to "enhance life" by just being healthy, and I just wanted to make that point.


Frank, Rebecca.

PROF. FUKUYAMA: I wanted to respond to something that Janet said, and then to ask Paul a question. I really think that the whole question of germ line engineering is one that we have to address. I think that — and, in fact, the complexity of genetic causation is actually one of the reasons that we have to address it, because the simple fact that we're not going to understand that complexity in its fullness is I think one of the reasons that it's dangerous.

I don't think that's going to stop people from, you know, going ahead and doing experiments on animals in which they modify, you know, one gene and it produces an effect, and then they will try to, you know, reproduce that in humans. And I think what's really problematic about that is precisely because that causality is so complex that it's not like approving a new drug — you know, the FDA approving a new drug where you have a certain set of side effects you're looking for.

I mean, the side effects of that kind of intervention could be, you know, things that don't show up until the — you know, the subject is 60 years old. I mean, they may be very subtle. It may upset all sorts of different kinds of balance.

So it's — I think that, you know, inherently there's got to be a different, you know, standard for approving that. But that — simply the fact that it's complex is not going to, you know, stop development in that area. And, therefore, I think it is something we need to look at.

My question for Paul is it really does seem that psychiatry is a really different domain. And, for example, I don't really understand the process by which things get entered into the DSM as disorders, because it seems to me that that's basically a political negotiation more than a scientific one.

But I wondered if you could — because in other areas of medicine I think there are things that people pretty much agree are pathologies, and there's good reason — there's an etiology, and so forth. But in psychiatry, that's not true.

DR. MCHUGH: For some psychiatrists it's not true. I'd put it to you that way. I think DSM-IV is the ultimate extension of a problem that we solved — we tried to solve 20 years ago, and it's now a problem in itself, demonstrating that the problems of today are due to the solutions of yesterday.

Let me just make that clear. In the 1970s, psychiatrists couldn't do research, really, because they couldn't agree on what was, for example, schizophrenia. You're called schizophrenia in Baltimore; you'd be called manic depression or maybe panic anxiety in San Diego.

The DSM process was to try to give us a common nomenclature with the idea that we would become more reliable. And, therefore, if I said I did research on schizophrenia and had these results in Baltimore, it would be replicable in Boston as they were trying to find reliability.

But DSM-IV and DSM-III are really a nomenclature that could as easily be organized alphabetically as it could any other way. And now we are really troubled by two things in it. One, that it's drifting away from medicine. We are inventing more and more diseases or disorders in DSM-IV, such that it's expanding exponentially. There are now 2,000 different forms of depression that you could figure out from that book.

And there are also conditions that are invented that are in that book. You have to just get a group of psychiatrists together, and if they say something exists they can put it in the book. I'm surprised — you know, I'm happily surprised that witches aren't in the book. There are criteria for finding a witch, after all, but we had that trouble before. So —

CHAIRMAN KASS: That's not a disorder anymore.

DR. MCHUGH: Excuse me?

CHAIRMAN KASS: I said that's not a disorder anymore.


DR. MCHUGH: That's not a disorder anymore, but it's operationalized.

CHAIRMAN KASS: It's a lifestyle.

DR. MCHUGH: I can show you the book in which they show you this is an operationalized term. You drop them in the water. If they sink, they're not a witch. If they float, they are.


Massachusetts has a lot to answer for.


The future right now, in my opinion — this is a side issue, but it relates to what we're talking about. Psychiatry has to move in a direction of more and more valid conditions that relate to certain kinds of underpinnings that relate to the brain or to other clear human disorders.

And we have not done that, and I think the next 10 years is going to be very interesting in the developing of DSM-V. If DSM-V is identical, or just an extension of DSM-IV, that will be a disaster for this discipline.

DR. KRAUTHAMMER: Could I add a cul-de-sac on that diversion? I worked on DSM-III in the '70s, particularly with Jerry Clerman on the depressive disorders. And you're right, Frank. There's a lot of politics in it in the end. It was — as was pointed out; it was a serious attempt to systematize nosology and to get sort of a reproducible list of symptoms and signs that would model what happens in the rest of medicine.

But in the end, of course, it's politics, unlike — I suppose unlike the criteria for Type 1 diabetes. The criteria for major depression are negotiable, so you negotiate them; you end up with a consensus.

The one virtue is that you establish a preliminary consensus in DSM-III, and then you spend a decade seeing if empirically it separates patients into groups that are therapeutically useful. And that's how over time you eliminate the politics. But as of now, there's a lot of politics in the negotiations.

CHAIRMAN KASS: Rebecca, Mike Gazzaniga.

PROF. DRESSER: When we talk about decision-making about enhancements or borderline conditions, I think we should approach it with the recognition that these decisions will be made at different levels. I doubt if there are many bans. There might be some. But there will be decisions on allocation of resources.

And professional standards — that is, clinicians saying here is what we consider to be legitimate practice of our profession, professional integrity issues — and then decisions by people who are seeking these interventions. And I think the rubber meets the road pretty much on these final two — in these final two areas about — and I think it was in the early '90s I was trying to help draft a statement on use of growth hormone for the American Academy of Pediatrics Bioethics Committee.

And we all agreed that this — the reason people don't want to be short is primarily due to social reasons. That is, if it weren't a stigmatized condition, and if cars and kitchens and so forth were designed to fit people who were short, then this would not be a problem.

On the other hand, the pediatricians say, "What am I supposed to do when the parents come in with their short kid? Everybody is miserable. It looks like the child is going to be short for genetic reasons. How do I say no to those people? You know, I need help."

So the pediatricians need help, and then the people seeking these technologies — I hope that we can help people think better about these choices, because I think a lot of the demand will come from them. So how can we help people be more thoughtful, aware of the risks? And, of course, most of these things will have some risks — and also, the nature of the benefit.

As Gil said, people do these things because they think it will make them happier. And how valid is that belief? Is there anything we can say about that belief?


DR. GAZZANIGA: Well, I want to take credit for having paid for two of Paul's two-shot enhancers last night —


— leading to his eloquent opening remarks that really paint a picture. I thought I'd follow up and just get off the germ thing and the clones and the embryos and talk about some of the other gadgets that are around, because I think this is one of the concerns that sort of comes out in the paper, and so forth.

So, in the sphere of high-tech possible aids that are coming down the pike, now being worked on diligently to — for therapy of spinal cord injury, there are people that are working on devices that can somehow read the electrophysiological state of the motor cortex and interpret it through mathematical algorithms that somehow figure out what the motor cortex is trying to say to the spinal cord, and then to physically jump over the lesion the person has at whatever level, plug in the electrodes below the lesion, and by thinking as it were their way through the movement, energize the neurons below the cut and thereby giving rise to mobility.

Now that's a — we're nowhere near there, but there are very, very clever people working hard at this and making advances. Slow, hard advances, I might add, but it's something that's in the tube.

Now, what then comes along is other research that shows that maybe there is some way you can read the desire to figure out what two plus two is by reading your brainwaves and then access this through some artifact that you might have on the side of your head that actually solves the problem for you.

So instead of you struggling with your multiplication tables or your — whatever, this device picks up the essential brain circuitries, pattern of activity, sends it over to this machine, the machine says, oh, he's trying to figure out this problem, the machine figures it out, sends it back to your brain, and the kid raises his hand right as the button — I got the answer before everybody else in the class.

That, too, is a dream at this point. It's talked about, written about, but no one really quite takes it seriously yet. But you can — the way that could work certainly is in the thought processes of some.

But I think this feeds back immediately to the — so there are these things. There are these whole other area of technological developments that the world is going to be hearing about in the press way before it gets solidly built up in the scientific literature.

But, of course, I'm kind of of the view that there isn't a thing that our human species doesn't adapt to once they think about it and absorb into its evolutionary sequence. And we have these enhancements all over the place. The kids now take their graphic calculator in to take the SAT test, and that didn't — that wasn't allowed a few years ago.

So there are environmental enhancers. You can go take the Kaplan test and pretty much bump your score up a couple hundred points if you work hard on it. And all of these things — and I don't think that a reasonable group of people, certainly those of us involved in higher education, see those things as relevant, particularly relevant variables, because what you want to do in science is try to identify the student that is creative, insightful, sees a problem in a way that everybody else in the lab doesn't see it.

And once they have an insight and then do the experiment, all of this sort of elevated notion of being higher on an SAT is just part of the data analysis. And the data analysis is — while it seems opaque and hard to do when you don't know anything about it, that's the easiest part of a scientific exchange is coming up with the idea and the insight on how to proceed is the challenge. And I don't think anybody has a clue about what sort of gene manipulation encourages that kind of thing. It's a rare, rare thing to see.

And, finally, to return to the germ line issue, which is obviously an important issue, there are many — I think the Council would be well advised to have, as we did yesterday, two leaders of this come in. There are certain major molecular biologists — Eric Lander comes to mind at MIT, who is totally against any germ line manipulation, and there are other biologists — I can't think of one right now, who would be the best for promoting it.

But there is major thinking going on in the major intellectual centers on this point, and I think we'd be well informed to hear about them before we go too far in thinking about it from an ethical point of view.

CHAIRMAN KASS: Michael, thank you.

Michael Sandel?

PROF. SANDEL: I wanted to go back to the moral questions associated with the allocation of resources that Mary Ann raised. And I think this is an issue whether we're in the realm of pharmacological or surgical or genetic interventions for enhancement.

There are a couple of ways one could imagine dealing with this problem. One of them struck me when a year or two ago I read an article about a cure for wrinkles, some kind of wrinkle remover that was produced by a cosmetics company and extremely successful financially.

And it turned out that the compound used in the wrinkle treatment if just slightly reformulated was also a cure for sleeping sickness. And the company agreed to work with a foundation and to make available for free through its production facilities this slightly reformulated version of the wrinkle cream which it could produce in massive amounts because of the huge market for enhancement to cure a disease which was far more morally significant but which would never have been invested in had that been the only reason.

When I read about this, I didn't know whether to be heartened or distressed, heartened that it was a creative solution to the problem, the distress that sleeping sickness and similar morally pressing diseases are only attended to insofar as they happen to coincide with a cure for wrinkles, and so that — insofar as there are those opportunities, that would be one way of dealing with the problem.

But I want to go back to the face lifts that Paul raised — low-tech enhancement — and to I think — the germ line questions force our attention to existing practices that may be morally questionable. And as for the face lifts, surgical or through this Botox, it seems to me — well, I'm not sure, Paul, where you put it on your list, but I take it you don't admire it. It's not something you find morally admirable — the purely cosmetic face lift.

One way we might deal with that — and Janet is worried about excessive regulation. We wouldn't need — if we found — of course, in all these cases, if we find something morally troubling it's a further question what the law should do or what regulation should do.

But if we agree that face lifts, for example, are not morally admirable, but yet they don't pose such a grave problem that they should be legally banned, what we might do with them is what we do with alcohol. We can impose a sin tax. We could consider that face lifts are not a crime but a sin, and, therefore, they should be subject to a sin tax, the revenues of which should go toward the health, or the restoring to health in the case of things like sleeping sickness and malaria that wouldn't otherwise get the resources. That's a modest proposal.

DR. MCHUGH: Can I just say what I do think about face-lifts?


It's all in this area of facial cosmetics, which go from treatments that I think we would be very happy to offer anybody to ones that we think that vanity is being served. And there is no — I don't see a good, clear line, because, again, orthodontia could be put into that, too.

Lots of people who were poor when they were children and couldn't have orthodontia and are still unhappy about their teeth get it in their forties and fifties. I had a secretary who, fortunately, got some — she began — I would hate to tax her for that, because she was always very distressed about her teeth.

PROF. SANDEL: Orthodontia is not a sin in the way face lifts are, insofar as it does have some relation to health, even though, you know, it may be marginal.

CHAIRMAN KASS: Elizabeth? Bill?

DR. HURLBUT: I think that one of the things that we have to do is to realize that we are already in an era of enhancement in a certain sense in ways that we haven't been fully attentive to as they've unfolded.

I mentioned the first day the issue of contraception, and here I don't bring it up to judge it, just to say that it was a kind of alteration of our natural reality that slipped in along the gradient of apparent human good, or at least a desire, that went — came in fairly unquestioned at the time, had a significant impact on altering our personal lives and our social existence, and now we're slowly getting a perspective on it.

But this brings me to what I really wanted to mention. That is that at the foundation of this whole question of enhancement are deeper philosophical, almost religious questions about, what is nature, and what kind of a mind has this world produced in the creatures that now have the power to govern nature?

Einstein said that the most incomprehensible thing about the world is that it's comprehensible. That's — I think he meant mathematically, but the question is whether it's morally comprehensible in the sense that we understand ourselves. It's clear that we live and will use our new powers along the gradients of our desires, but within the natural mind it seems to me that desires function as impulses toward a direction, not necessarily a destination as such.

So that if desires, like, for example, the desire to eat that Dan was just speaking of, it may be good for you ultimately to eat less, but in our environment of evolution and adaptation we developed a strong tendency to want to eat more. And so now that we have refrigerators we basically have at our hands more than it's good for us to eat. And so now we have an epidemic of obesity.

So that seems to me to be a fundamental issue. We have to figure out how we relate to nature, what is good within the order of nature, and it's going to take not just scientific knowledge but a kind of self-knowledge of what's driving the force that would produce the gradients along which we would move toward our enhancements.

Does that make sense?

CHAIRMAN KASS: Yes. Thank you.

Elizabeth, did you want to — nothing? Bill May, and then I'd like to put myself on the list.

DR. MAY: As I recall, Alasdair MacIntyre a number of years ago wrote a piece responding to Joe Fletcher's essay on the markers of humanhood, which Joe Fletcher had justified designing improvements in human beings' intelligence and the rest.

And MacIntyre puzzled on the question of what kind of humanity you would like to see in future people, and he ultimately decided that the kind of humanity you'd like to see there would be precisely those dispositions that would lead them to renounce the hubris, the arrogance of designing irreversibly their descendants. A very interesting, ironic piece.

I suppose germ line enhancements would give future generations one more reason to resent the overreaching of their parents — their designer parents — unless one could build into the enhancement the disposition to gratitude.


CHAIRMAN KASS: Let me make a couple of comments and then try to maybe get a little more focus into the way in which we are proceeding. I think — just a number of observations I guess, not altogether coherent.

First of all, I think we all recognize that there is continuity here with no lines, which makes this very difficult. The people who trot into this discussion by saying enhancement versus therapy haven't thought enough about it, because the area — nevertheless, that there is a twilight doesn't mean that at a certain point you know that it's day and at a certain point that you know that it's night.

And it's incumbent upon us if we think that there is some distinction here, however fuzzy the boundary is, that's worth making — it seems to me it's worth struggling to try to clarify what it is that is at stake and what it is that — how we might evaluate it. That would be point number one.

And I think this point has been made by others, but the fact that there is already precedent — that was in a way the part — the force of Michael Sandel's question to you, Paul. The fact that certain sorts of things are already accepted, and, therefore, might serve as precedent for the next step cuts in two directions.

We might reevaluate where it is we have gone and see it only in the light of hindsight. And the fact that there are environmental kinds of enhancements may or may not be precedent-setting for what to think about enhancements written into the human body or mind, whether reversible or not.

I'm not begging the question. I'm simply raising it. We came to this before when one wondered about, what's the difference between bioengineering and social engineering? And does it have a kind of different moral character for us to consider?

Third comment — and that has to do with I think it's very — it has to do with the business about inequality and justice. And my response to Michael's very astute observation is to say it's very easy I think for us to treat this question in terms of the distributive justice question and to also recognize what a precious — what preciousness there is to be sitting talking about these sorts of things when there are really much more profound human concerns and questions about the uses of our resources, and so on.

But I think we would do ourselves a disservice if we immediately said, look, the real problem here is that some will have and some will not. I think the first question is whether the thing which is sought for is, in fact, desirable because there will be a great deal of pressure to have what this is, if, in fact, it turns out to be good. And all you'd have to do would be to take a look at the example of the Ritalin use for improved test results.

Let's assume for the moment that there is something like this which actually improves attention span and people get wind of it. The pressure, even on the people who have no interest in using it, is comparable to the pressure that is now available to extra tutoring and extra — those sorts of things.

So that even if it — we don't — even if we leave these matters to free, private choice, the social pressure in the direction of using these various kinds of enhancements, at least in this community, would be considerable. So I think it's rather important for us to try to look — to not start with the question of inequality or distribution, but to look at the question of the enhancement itself, or the alleged enhancement itself, and see what one thinks about it and what its human costs might be, assuming that the blessings of it could flow to everybody. Okay?

Now, maybe we could make some progress on this if we took one of the examples here that's been put before us by the staff for discussion. And I don't know which of them would be most fruitful, but —



PROF. FUKUYAMA: I have a suggestion.

CHAIRMAN KASS: Oh, please, Frank.

PROF. FUKUYAMA: I mean, this — I mean, I actually was going to talk about the Ritalin example, which I think would serve your purpose as an illustration of —

CHAIRMAN KASS: Well, let's do that. Do you want to start off?

PROF. FUKUYAMA: Yes. Well, I mean, this in a way anticipates what I was going to say when we started talking about regulation in the next session. But you already have a case with the drug Ritalin where you basically have a distinction made between therapeutic and enhancement uses.

And, actually, the point I was going to make when I put myself on the queue was that I think that actually it is easier to make that distinction in practice by a regulatory agency than it is to make it theoretically sitting around a table, you know, with very wise people like this, because, in fact, you know, there is no — well, if you take something like Ritalin, it's used to treat this condition ADHD, which it seems to me is a classic case of a socially constructed disease.

I mean, it's not actually a disease, but it's simply the tail of a, you know, distribution of normal behaviors. And when you get far enough out into the tail, you know, by these very subjective diagnostic criteria that are now in the DSM, you say, okay, this kid has ADHD, and then you can — a doctor can prescribe Ritalin.

And I think using your example about the twilight, you know, there is no — people wouldn't have any question about its appropriateness for people way out in the tail. And I think they would also have a lot of question about pure enhancement use when you're simply, you know, cramming for an SAT, and, you know, have no problem with attention normally.

But you've got this big area, you know, in the middle where I think most of the controversy lies about, you know, whether it's being over-prescribed. And so you can't imagine a drug or a condition that is more subject to this fuzzy boundary between therapy and enhancement, and yet we regulate it, and I think we regulate it, you know, not terribly unsuccessfully.

The DEA prescribes it. It's a Schedule II drug, which means that it is controlled by the DEA as a controlled substance because it is an amphetamine, and it is prohibited as illegal to use it for, you know, pure enhancement uses. But it can be prescribed for therapeutic uses by a physician.

And, you know, you can't justify theoretically, you know, why the cutoff line is where these particular regulatory agencies say it is. And then there's obviously a lot of argument back and forth. And yet in practice, you know, we are able to maintain that kind of a distinction. And I would say that in a lot of other areas, as a practical matter, we will be able to do that.

In all regulation, no regulator can really ever justify the line that they make. I mean, they say, you know, eight parts per million rather than 11 parts per million. Well, why? I mean, you know, in fact it could be moved up or down. But, you know, regulation is a political process in which you get various interested parties that push and shove. And if the institution is designed properly, you can actually come up with a kind of social compromise that is not theoretically justifiable, but, in fact, you know, draws that distinction.

And I think that, you know, as a matter of, you know — I mean, there will be plenty of these fuzzy areas, but I think we already have precedent for society drawing distinctions between, you know, therapeutic and enhancement uses of, you know, psychotropic drugs. And so I don't see why that won't be possible to do in the case of, you know, upcoming technologies as well.

CHAIRMAN KASS: Well, what's your confidence in this? No, I mean, because, I mean, so far the pressures for pushing the boundary have been relatively slight. I mean, well, put it — I guess your question could be followed up in a number of different ways.

Is the implication of this that the philosophical question of where the boundary is, or is it good or bad, is not worth our trouble because the prudent people will somehow intuitively know where it is and take care of it if we give them the proper regulatory mechanism?

Or that the medical profession, which is in charge of prescribing, already has sort of sufficient internalized norms of what is the proper professional use and that they won't give out feel-good pills or, in the elite places, actually administer Ritalin on the side for testing purposes. What follows from this?

PROF. FUKUYAMA: Well, what I draw from this is that you see — you hear a lot of discussions, like the one we've had this morning, in which people quite rightly say, oh, it's very hard to draw a distinction between therapy and enhancement and give lots of examples why that's the case. And the conclusion they draw from that is, therefore, let's not even try to, you know, make that boundary as a practical matter.

And all I'm saying is I don't — I mean, I'm sure there are a lot of cases where it's going to be very difficult to draw that boundary as a practical issue. But we shouldn't give up on trying to design institutions that can maintain that distinction on the basis of a theoretical puzzlement about, you know, where that boundary, you know, precisely can be drawn.

CHAIRMAN KASS: Jim, to this?



DR. WILSON: I very much agree with Frank's view. My sense of regulation is that you don't regulate until you have a concrete problem. Regulation in advance, creating entities designed to solve large problems, is creating great mischief in the country.

We created the Interstate Commerce Commission allegedly to regulate the flow of goods across the states — an ambitious title. It worked reasonably well with respect to railroads, and, in particular, it worked reasonably well in getting railroads that took people for short distances, not to charge them more money than other railroads that took people for longer distances. This is a way of ending cartelization and short haul railroads.

But then, lo and behold, trucking came along. Instead of thinking of trucking as a problem, we gave it to the ICC, which made a terrible mess of it. The Federal Communications Commission was started to deal with the problem of radio, but then television came along, and then cable television came along. And the FCC made a mess of handling these other things.

The lesson I draw as a narrow gauge, unphilosophical, political scientist is that society, at least in this country, operates best when it has a concrete problem to worry about.

Now, the Ritalin example that Frank gave I think is a pretty good example. Ritalin comes into use, and after some pulling and hauling, people decide there's some good uses and some bad uses. And they create a kind of regulatory regime around it, which allows mistakes to be made — this will always happen — but by and large probably tries to allocate it in the right way.

But much of what we've talked about this morning, these distant, remote — as Janet Rowley put it out — possibilities for doing X, Y, and Z, I don't think we can draw any political or regulatory implications from these statements at all.

CHAIRMAN KASS: Well, could we separate — since the regulatory question comes after the break, could we bracket that for the moment and stay — I mean, stay either with the Ritalin example — and, Gil, do you want to go back to Frank's comment or — please.

PROF. MEILAENDER: If that's okay.


PROF. MEILAENDER: Just, I mean, I think it — I think you're right, Frank, that there is a sense in which almost any line drawn is often, in a certain sense, arbitrary — at least in the sense that it could reasonably be drawn at some other places, and so forth.

But I'd be sorry to think that meant that the theoretical discussion was unnecessary. I mean, partly just I'd like to keep drawing my salary. But we want to know why somebody should be drawing a line on this matter in the first place. Don't we? Even granting that there is going to be a slightly haphazard quality to where the line comes down, and that one could argue for different places.

But we want to know why we shouldn't just do as we please in this matter. And in order to answer that question, it seems to me we are going to have to — we're going to have to think about the theoretical question. I mean, so it seems to me it's possible to agree in some considerable measure with your point, but not think that that means that the theoretical discussion is, so to speak, beside the point or unnecessary. I mean, both aspects are going to be necessary.

CHAIRMAN KASS: Yes. Good. Let me try you, Frank. And why — let's take the Ritalin example and leave the regulatory question alone, but just try to think it through. Why should we not allow people freely or — that makes it into a legal question. What's morally questionable, or why should we have any doubts about allowing people to use Ritalin for attention-improving — just for increased attention span, never mind for tests? Why shouldn't they simply be allowed to use it for non-therapeutic ends? But — because it makes them more alert.

PROF. FUKUYAMA: Well, now I — you know, by my previous intervention, I didn't mean to cut off the philosophical discussion, because I think I absolutely agree it's very important. So I'm glad you're drawing us back to that.

I mean, in my view, what's problematic about the enhancement use of Ritalin is that it, you know, challenges certain moral ideas we have about personality and about character, which is that, you know, we learn, for example, attention and focus and putting certain things above certain other things as a result of a, you know, process of education and socialization that allows us to, you know, over time do things — you know, shape our characters in ways that we're potentially there at birth, but — you know, but required a certain kind of moral education.

And, you know, the Ritalin in many cases seems to be a convenient shortcut or a medical shortcut around that that may produce, you know, something like the effect, but doesn't have the — you know, the same effect on character. And, you know, I think it challenges, in a certain way, our traditional understanding of character.

Now, that then begs the, you know, prior question of, why is that traditional understanding of character, you know, something that we want to protect? And, you know, I think that's a worthwhile discussion as well.


DR. WILSON: Frank, how would you distinguish the use of Ritalin for enhancing one's attentiveness from using a pocket calculator? I mean, was there a moral significance attached to memorizing the multiplication tables which has now been set aside, or what's the difference here between memorizing the multiplication tables or being more attentive during a test? This is a genuine question.

PROF. FUKUYAMA: Yes. No, I — because I think that moral character traditionally had to do with the learning of certain internal habits that, you know, related to, you know, basically being able to, you know, put long-term goals ahead of short-term goals, you know, being able to defer immediate gratifications, you know, for the sake of longer-term things, being able to try to, you know, concentrate one's energies on certain things, and that these are, you know, kind of permanently valuable traits if — you know, if they in fact become habits, you know, that an individual has.

Now, I suppose you could say knowing the multiplication tables and not having to use a calculator is — you know, is a handy thing, but I do think that somehow that internal shaping of character, you know, is more essential to our understanding of what, you know, human goods, you know, just in themselves are than, you know, being able to calculate things in your head.


DR. GAZZANIGA: Okay. Let's do a case history here. Leon is chair of this panel. It's beginning to get to him. He's working the midnight oil to 2:00. He's up at 6:00. The White House is calling him. He's got this panel that's not agreeing with him. He's working like crazy to make it all work. This goes on for months.

CHAIRMAN KASS: You could fix that, you know?


DR. GAZZANIGA: It goes on for months, and he finally calls up Paul and he says, "Paul, I've got this problem."


"Around 2:00 to 4:00, 5:00, every afternoon, I have lassitude. I just, you know, I just can't concentrate." And Paul says, "You know, I can fix that. I can fix that. We'll just pop a little Ritalin in there, and you'll just get through 2:00 to 5:00, and you will be — continue your high level of productivity for these highly moral questions you're working on."


Would you take it?

CHAIRMAN KASS: I've been to see him.


DR. MCHUGH: I wouldn't prescribe it, but how many —

CHAIRMAN KASS: I went to somebody else.

DR. MCHUGH: Excuse me, Mike?

DR. GAZZANIGA: What's your take on how many physicians would say, "Fine, take a little Ritalin"?

DR. MCHUGH: Well, it's turning out over time that there are some physicians — you can find physicians to do almost anything, obviously. And so some might well do that and, by the way, then get Leon addicted to an amphetamine-like drug, and ultimately get him quite sick.

CHAIRMAN KASS: See, we have to clean this up. Let's not make it easy for ourselves by introducing the problem of addiction. Okay? Now, it might very well be that any of these drugs that are powerful enough to make the kinds of changes that we're talking about — I mean, any prudent person will say anything that's powerful enough to make that kind of a change is a dangerous drug. If it's going to mess with your brain, be careful.

But let's not make it easy for ourself by talking about the secondary consequences either of addiction, or it's bad for my liver, or something like that. But to get, really, to the direct point of what the difficulty with this is.

And I think — let me try it. I'm not sure I can do this very well, although the draft that the staff prepared has something about this. I'm not sure I would put it in terms of moral character as much as I would try to put it in terms of what the issue is. I'm not — not the final judgment. But the question has something to do with the deep structure of what it means to be humanly active.

I think one could affect the outcome of certain kinds of performances and achievements, but they might be less the achievements of the person that — and this is not so much a moral claim that effort is good for you, though I would be willing to make that separately. But it's a different activity if it is not somehow the activity of the embodied and soul delighted human being trying to be at work and doing the work, if you somehow detach the end result from the agent.

So that I can see how you might get different achievements but they — it's not so clear that they would be the achievement of the agent. There's a certain line I think in the staff presentation where if you doped up several athletes — and this is not just a competition point, but what you'd really be praising would be the chemists rather than the agents. And I know what's coming next, because we're just bags of chemicals and it's very complicated.

But I think what one is most concerned here about is not just the unfair advantage that some might have over others, but the tendency to dissociate and disaggregate the deep structure of human activity, the changing — the relation between effort and activity, the changing of the relation between satisfaction and the activity that produces the satisfaction, and the preoccupation with the deed and the achievement separate from its being the achievement of the human agent at work. It's —

DR. GAZZANIGA: Wait a minute. Come on, that's a little too heavy. We're talking about just having you awake.

CHAIRMAN KASS: No, no. I understand.


No, I understand. And I think you've put it very nicely, because it seems to me that some of these kinds of things — that would be a perfect one — would be not so much an intervention that would produce a certain result, but would be an intervention that might make me much more fit to be who I am alertly. Right?


CHAIRMAN KASS: I'd just — I mean, to be is to be awake. And if I am flagging, then all kinds of human possibilities are imperiled.

DR. KRAUTHAMMER: But what if his problem is not wakedness but he wants distraction and a bit of a buzz? Isn't this the same question as, why do we not allow people to take marijuana if they want to achieve "happiness" that way? I mean, we have decided as a society that's not a good idea. Is that that different a question?

DR. BLACKBURN: I'd just extend it the other way. Caffeine and coffee — we all, you know, very frequently use it. And I think that's a very interesting example because it has parallels with Ritalin because it, you know, really does have a pharmacological effect, and it's sort of on the other side.

I think we have the difficulty of a continuum of things to think about, and Ritalin seems a little more extreme, because, of course, there is a risk of addiction, and we know there's a risk of caffeine addiction. But I think apart from road rage nothing has been attributed to — you know, there aren't really bad social effects necessarily from —

DR. GEORGE: Leon, just on this point? Or is it — it's Robby.

CHAIRMAN KASS: Robby. Sorry, Robby.

DR. GEORGE: Elizabeth, the parallel with Ritalin in one respect may be even more exact than you think. A few years ago there was some study done that was reported in one of the magazines that comes with so many newspapers — I think it might have been Parade magazine — that seemed to indicate that coffee and caffeine before taking SAT tests improved measurably students' performance on tests.

Well, you can imagine what the result of this was. Kids who never drank coffee were given a cup of coffee before going in to the exam. And, of course, since the Lord works in not so mysterious ways sometimes his wonders to perform, the kids all had stomach pain and didn't do so well on —


DR. BLACKBURN: It's the sin tax, right?


PROF. MEILAENDER: Yes. This is relating to this discussion, but it comes back to a point that Rebecca had raised earlier. She said, you know, we need to think about what the benefit really is, and so forth.

And, I mean, we don't want to sound like sort of a moral nanny in some ways, but —

PROF. SANDEL: It's a little late in the day to be making —


— that disclaimer, isn't it?

PROF. MEILAENDER: Well, I was making it on your behalf.


Sorry. But — and this is by no means a full solution to the problem. I don't mean it in that way at all. I mean, I don't think it gets us off the hook for thinking about the therapy enhancement distinction or anything like that.

But if you think about the thing that Michael raised, we would have far less to fear from these matters if we were better people. And, I mean, there should be some way to say that without just sounding moralistic. In other words, if you're going to bed at 2:00 and getting up at 6:00 because you think the bioethical future of the country rests on what you do, well, then, let's think about that and a virtue like humility, for instance.


If you fear for the future if this Council doesn't accomplish some of the good — well, let's think about virtues like hope or courage, you know. And as I said, I don't know how to —

CHAIRMAN KASS: Do they come in a bottle?


PROF. MEILAENDER: Well, no, they don't, in fact. And we would have less to fear about these questions, or even about Paul, on one particular occasion, maybe giving you — prescribing the Ritalin if we were better people in a way. Now, that doesn't solve the problem. We're not going to become better people just all of a sudden.

But I think in some way it wouldn't be a complete thinking through of the issue if we didn't take account of that.

CHAIRMAN KASS: Would someone like to join that?

DR. MCHUGH: I'd like to join that and agree with it.


DR. MCHUGH: And point out that what Michael has described is what happens quite frequently now in my office. I have a lot of people coming in and telling me what I should prescribe to them. They've picked it up on the newspaper or on the ads, and I'm always throwing it back onto the very things that Gil is talking about.

The similar thing was raised by Rebecca when she says you bring kids in. At least three times a year I have very distinguished people bring their what I consider wonderful young son in. They're all Phi Beta Kappa, Harvard graduates, and the like, and the kid's IQ is 110. You know, he's reverted towards the mean.

And the fact is that he's six foot tall, he can hit — you know, all net from the center of the basketball field, handsome as the devil, but they are so sorry that he's not valedictorian or things of that. And my job is to give them hope by telling them —


— what a wonderful kid this is. Okay? So that very often I avoid this process of offering medication by talking to people about the meaning of what they're doing, how they are doing it, offering them alternative ways of looking at what they're doing, and some of them are pleased.


I emphasize some because —


— there are quite a few who go and find another doctor to do exactly what they want done.


DR. HURLBUT: So, Gil, do I understand you saying that what makes an enhancement legitimate is the sort of final goal toward which it is set within the larger picture of what human existence is for? What I'm thinking of here is beta blockers, for example, are — they calm your hands, okay? And people use them for a wide variety of things.

I went to a guitar concert once and then found out that the guitarist was using beta blockers. And, you know, half the fun of going to a concert is to see if they can do it in front of an audience.

On the other hand, if my child were in for eye surgery, I wouldn't mind if the surgeon used beta blockers. So it seems to me that behind this whole thing — that's why I said this thing about desire earlier. Desire is — Leon wrote, "Desire, not DNA, is the deepest principle of life." But if that's true, then our desires have to be — form a very coherent cosmology that it's — is it once in the service of our individual life and the benefits of our collective lives?

Because so much of what drives the human psyche underneath is — I don't know what Mike thinks about theories of unconsciousness, and so forth, but I — there's an awful lot of discussion now in neuroscience and related cognitive psychology that a lot of what we desire is driven by things under the surface that nature has put the surface goal into our mind, but behind it connected a lot of things.

That's why I brought the issue of contraception, because there's an example where we feel a desire for one thing but nature brings along a second thing with it. Well, it's just an example. I don't want to use it for anything more than that right now, but the point is that that's a major disconnect in human history — to disconnect a desire from its natural end.

And so somehow we need — I think behind this whole question is a deep question of nature, a deep question of the degree to which we know what is good in nature, and how much we dare to intervene to promote what we think on the surface is what our lives are about and perhaps then miss the thing that they're really about.

I said the first day — I promise this is the last time I'll say this, Leon — but I think we could put ourselves in danger of walking ourselves right off the stage of the drama of our deepest significance.

CHAIRMAN KASS: Let me make a suggestion. I don't know that I can digest this conversation either now. Fortunately, we'll have a transcript. And if we are more efficient this time than we've been in the past, which means if the people at HHS actually will post what we give them, within a week or so we will have a transcript so people can revisit some of these things and think more about it.

I take it that there is encouragement here for at least exploring this topic down the road. There are risks in how we formulate it. We have to pick our topics — the subtopics carefully. Let me say for myself, I'm not sure that the language of enhancement versus therapy is the optimum way to do this.

It might be better to leave that language alone and to ask ourselves, really, the question of, what, if any, are the boundaries between the admirable and the less admirable users of these powers without having to tie it into some definitional thing of what you mean by an enhancement or not.

And part of what's at stake there I think is — and I'm not sure that — Bill, that this would be a way that you would — a reformulation of the point you're making. That would be friendly.

But it does seem to me that thinking about the question of better and worse uses or admirable or less admirable uses or unadmirable uses or degrading uses is some kind of notion explicit — tacit if not explicit — of what it would mean actually to conduce to human flourishing and our fulfillment, which is not a simple matter and it's not for governmental commissions to settle. But at least we can be mindful of the fact that some tacit answer to that question is somehow implied in how one thinks through what norms are we to use when we're not engaged in the business of healing or assisting.

So let — Michael, please.

PROF. SANDEL: Could I just add, along these lines, as I've heard this discussion, I think that however we came at it there is real enthusiasm for exploring the human and the moral implications of enhancements or of — or going beyond aiming at perfection.

And if I could just add a small correction. Before when you chastised those of us who raised the moral questions of allocation for putting that ahead of the underlying moral questions of enhancement, I didn't hear any of that. I didn't hear any suggestion that that should somehow substitute or preempt a discussion of the human consequences and the moral consequences of aiming at perfection. I thought that had been emphasized by everyone who spoke, and I hope that we take that up.

CHAIRMAN KASS: Yes. Thank you. It wasn't a chastisement. If it came across that way, I didn't — it wasn't meant that way. But thank you.

Charles, do you want a word? And then we should stop.

DR. KRAUTHAMMER: Yes. Just one word and a caution. I think as we think about this it's important for us to understand how our discussion will differ from the decades-long debate that the country has had on recreational drugs, which is a sort of paradigm I think of this question. So what are we contributing?

I mean, obviously, we'll be looking at other aspects of this. But fundamentally, I have yet to see how our debate about enhancement and all the issues that we have raised differ from the debate that people have about whether or not people ought to be able to use stuff that makes them feel better, and whether that should be legal or not.

It's an old debate. I'm not sure what's new.

CHAIRMAN KASS: Well, let me say a quick word on this. I mean, it — the temptation is to go either into euphorian drugs or cosmetic surgery, and things of that sort, which are — one could have one's opinions about it, but I take it there are serious people seriously thinking not about just having — letting people have their jollies, but actually doing things that might improve what we are constitutionally, whether it be through computer implants or neuropharmacological interventions, that would actually not just do things that would make us feel better but that might actually transfer in some structural way what we're capable of.

DR. KRAUTHAMMER: Well, that's precisely where I think we ought to focus, because otherwise we would be recreating an old debate.

CHAIRMAN KASS: Yes. But that —

DR. KRAUTHAMMER: It should precisely be about changing human capacities.

PROF. SANDEL: Well, the other difference is the next generation.

DR. KRAUTHAMMER: Right. In germ line, which I was advocating that we emphasize. But since other people have been arguing that it's too long, good term, and perhaps theoretical, I was asking in that case what — how would our debate differ from the older debate here?

CHAIRMAN KASS: Okay. We could use some help at headquarters on this topic. I mean, I don't know — I haven't heard anybody say this is not interesting or not important. The question is how to do it and to do it well.

And since you have an assignment for something on the other topic due in two weeks, let's make this optional. But it would be very nice if there were a subgroup of this — of the members who are especially interested in this if we could hear from you just by letter of either reflections on this conversation, suggestions for how to proceed, and we will try to, in light of that, see where we should go next on this topic and how to do it fruitfully and usefully.

With the usual kind of lack of clear and coherent structure of such a preliminary conversation, let's declare this one a success, take a break, and come back, oh, at 25 of 11:00 for the regulatory discussion.

(Whereupon, the proceedings in the foregoing matter went off the record at 10:17 a.m. and went back on the record at 10:44 a.m.)


CHAIRMAN KASS: All right. We convene for the second-to-the-last session. We will have a session for public comment beginning shortly after noon, after 12:00, but this session is an exploratory conversation on the subject of regulation of biomedical technologies. And it's a subject that Frank Fukuyama has especially been interested in.

Since I mentioned it in the first meeting and Frank prepared the — a short memo at our request, Frank, do you want to say something further about it to get started? We've had a couple other people prepare to lead off in response, but would you like to just hit a couple of high points?


CHAIRMAN KASS: And then, we'll take it from there.

PROF. FUKUYAMA: Yes. Well, I — you know, I must say I begin this not as any fan of regulation, but I do think it's worthwhile considering whether we need to think about a new set of institutions to regulate biotechnology.

Now there are a couple of I guess precedents for this. One is, you know, something like the Interstate Commerce Commission that Jim Wilson mentioned. Actually, I appreciate this idea that you shouldn't create institutions in the absence of real problems. I actually think that we have real problems that such an institution would address.

But it seems to me that a lot of Jim's examples actually — I'm not sure which direction they point to, because they were all cases in which you had established regulatory agencies that had to deal with a new technology and try to incorporate, you know, that into a preexisting regulatory structure.

So trucks into a system that had been designed to regulate railroads or, you know, satellite television into a system that had been designed to regulate, you know, land-based telephones. And the question is whether we aren't at such a juncture.

And, in fact, if you look at the FAA — you know, when airplanes came along, people decided that this was a sufficiently different technology that they didn't give it to the Interstate Commerce Commission, which was an option, you know, that was available at the time.

And so now in agricultural biotechnology, the Reagan administration actually had a series of meetings in the 1980s to decide whether the new, you know, recombinant DNA technology was sufficiently different that it required a new regulatory structure. And the result of that, they decided they were going to regulate on the basis of product, not process.

It wasn't sufficiently different, and I think that was a — you know, a perfectly defensible decision on their part. And so right now agricultural biotechnology is regulated by the Agriculture Department, the FDA, and the EPA.

I think that there are a number of reasons that I outlined in the memo for thinking that, you know, we're going to face a lot of problems that Congress should not have to intervene on. I mean, there are just going to be too many decisions that will have to be made for Congress to intervene the way it is intervening on the question of human cloning, which means some delegation of decision-making authority to another agency.

Besides the ones I listed in the memo, if you just think about the issues we talked about yesterday having to do with stem cells and the treatment of embryos, you know, one clear approach to — that would satisfy, for example, a lot of the concerns I have about cloning and embryos would be to establish a clear-cut regulatory structure for experimentation on embryos.

So that, for example, the line of questioning that Bill started, you know, that right now we want to do things to embryos that aren't older than 14 days, but supposing down the road someone will decide that you actually need to do something to fetuses, you know, one way of solving that — I mean, if your real worry in the short term is that slippery slope, then clearly one solution to that is to set up a regulatory structure that would cut things off at 14 days and say, no, you cannot — you know, we're going to permit cloning or stem cell research up to this point but not further, and put a break on that particular slope.

And there's actually a model out there, which is this Human Fertilization and Embryology Agency, in Britain that does that, that regulates embryo research. It regulates their IVF industry and establishes these kinds of rules for, you know, that sort of experimentation. And they've already done it. In fact, it's a 10-year old agency.

And I think that, you know, I personally do not have any concrete ideas about, you know, what the institutional design for such an agency or — you know, first of all, I'm not wedded to the fact that we need a new agency. I think simply that we need to think about it, but — and I'm not wedded, certainly, to any particular institutional design.

But I do think that it is an issue that we need to look at very concretely, because there really are holes in the current structure. I mean, the one — the biggest hole really has to do with the whole, you know, private sector and the whole private, you know, biotech industry, which does not fall under the NIH's rulemaking power, which, incidentally, the British law, you know, fixes.

There is no such distinction between public and private in the British regulatory system. And that's a problem that comes up with — you know, with an agency like the RAC, the Recombinant DNA Advisory Committee.

Janet and I were talking about this over breakfast. I think that that was an exemplary, you know, instance of self-regulation by scientists, and it worked — you know, is a system that worked, you know, quite well in its inception.

My understanding is that a lot of people that work with it now think that the industry and the — you know, the structure of scientific research in the United States at this point has outgrown that particular structure, because there is so much that's now done, you know, in the private sector.

Now, I don't necessarily believe that — I'm not trying to argue that we need more formal regulation or that self-regulation is impossible. I just think that, you know, it's a serious set of issues that — you know, that deserve to be looked at.

So let's — all right. Let me just stop there.

CHAIRMAN KASS: Thank you very much.

I have asked Rebecca Dresser to open up response with — after Frank's introduction. Please.

PROF. DRESSER: First, I'd like to commend Frank for his cogent and articulate case in favor of a more systematic approach to regulating biotechnology. In calling for added oversight, he really joins a number of other scholars and advisory groups addressing bioethics issues.

For example, in 1995, Dr. Jay Katz, a respected medical ethicist, called on the government to create a national board authorized to regulate all research involving human subjects, including funded by the private sector. The board, in his proposal, would consider big picture questions that are too broad and complex for institutional review boards to evaluate.

Others have made similar proposals contending that a national board is needed to review proposals for research that could affect the human germ line, research on xenografts, research on certain assisted reproduction methods, and experimental attempts to create human-animal hybrids.

Fukuyama writes — and this is a quote — "Deciding where precisely we should draw lines concerning technologies that have not yet come into being is not a fruitful exercise at this point. It's less important at this point to make up a definitive list of restrictions than to think about general principles that should govern the development and use of biotechnology and to begin designing institutions that will enable us to make critical decisions in the future."

I agree with this, but I do want to emphasize the challenges that are in here and the effort to settle on even general principles and institutional design.

Difficulties in carrying out these tasks are a major reason why the earlier proposals I mentioned have failed to produce national oversight systems. Let me give you a couple of examples. In the 1970s, Department of Health, Education, and Welfare created an Ethics Advisory Board to determine whether the Federal Government should fund research on in vitro fertilization and early human development.

The Board was given the responsibility to review each proposal seeking government funds. So it reviewed the topic and made general recommendations about the criteria that should govern federal funding. But then, its charter lapsed in 1980, and it wasn't renewed. And then throughout different administrations the Department of Health and Human Services Secretaries, nobody would pick this up off the desk and would appoint another Ethics Advisory Board.

So most people looking at this attributed the inaction to politics, controversy surrounding the status of developing human life, produced a reluctance to adopt explicit government policy on IVF research. As a result, the Federal Government failed to engage in oversight of research related to assisted reproduction, and this is what led to our current situation in which such research is supported by private funds, subject only to voluntary guidelines prepared by professional organizations and by the researcher's personal ethical beliefs.

A more recent example of the difficulties in establishing even general principles and oversight mechanisms concerns research involving people with dementia and other mental disorders that may affect decision-making capacity.

Many people think that current U.S. regulations are inadequate to resolve the ethical issues that may arise in research involving this population. In 1998, our predecessor, the National Bioethics Advisory Commission, produced an extensive report and recommendations including recommendations that the Secretary of DHHS appoint a national special standing panel to review certain ethically controversial proposals and supply guidance to IRBs reviewing studies involving this population.

After that, though, some psychiatric researchers spoke out against this recommendation, claiming that it would impede the search for treatments to help people with mental illnesses.

And because of disagreement, then, about substantive principles, such as the degree of risk that's acceptable in research involving people who have impaired decision-making capacity, and disagreement about the structure of oversight, whether it should be national or whether local IRBs were sufficient, because of these disagreements the DHHS has not created this special standing panel.

So I think we cannot underestimate the barriers to moving forward. So then, how do we begin the task of developing general principles and designing institutions that would apply them?

Well, first, I do think existing institutions could apply existing principles in ways that would address some of the moral issues that biotechnology raises.

As pointed out in our cloning discussions, current U.S. regulations say that risks to human research participants must be reasonable in relation to expected benefits, either to participants if there are any, or to the importance of the knowledge that the study will produce.

So the regulations incorporate this idea of justified risk to subjects. And I think this requirement to determine whether a study will generate information that is important enough to justify exposing study participants to risks offers an opportunity for IRBs to evaluate whether, for example, an experimental intervention that could increase a child's height offers a significant enough benefit to justify exposing children to physical, emotional, and social burdens in the study process.

This offers a mechanism for determining whether the potential benefits available through experimental interventions on what many of us would view as enhancements warrant exposing children to the risks present in the testing process.

FDA regulations that exist now also offer related opportunities. The FDA does require all private research sponsors seeking to test drugs, devices, and biologics to have their studies reviewed by IRBs before there is any human exposure. And the regulations direct IRBs to evaluate, again, whether the risks presented in — by an investigative drug or device are reasonable in relation to potential benefits.

FDA officials deciding whether a product is safe and effective enough to release into the market can also take into account relative harms and benefits. Former Commissioner David Kessler did just this in 1992 when he said that silicone breast implants would be available only to women who had had mastectomies. He decided that the benefits of the implants used for cosmetic purposes failed to justify exposing women to risks of this device. That is, the risks of the implants were unreasonable in relation to the cosmetic benefits.

In his judgment, implants for enhancement purposes were too risky, and, thus, unsafe. But the risks were acceptable if the implants were part of treating a disease.

Now, in defending the ruling he wrote, "Certainly, as a society we are far from according cosmetic interventions the same importance as a matter of public health that we accord to cancer treatments." So whether or not one agrees with this particular judgment, I think the case does show that existing FDA standards permit the agency to make decisions based on comparative harms and benefits available through biotechnology interventions.

Nevertheless, I do agree that broader standards than currently exist are needed to respond adequately to these innovations, and also that the current oversight institutions are inadequate to produce such a response.

Indeed, the current U.S. regulations explicitly direct IRBs not to consider as research risks, "possible long-range effects of applying knowledge gained in the research — for example, the possible effects of the research on public policy." Yet this is exactly the sort of effect that Fukuyama and many other people are worried about.

Now, of course, assessing the moral and social implications of biotechnology innovations presents daunting questions. In most cases, review groups have to evaluate potential harms and benefits to future generations, and these are effects that are highly uncertain and depend on many other variables besides technology development. I've heard them described as radically contingent.

And so settling on general principles won't be easy. For example, in Frank's materials he mentioned the precautionary principle that they use in Europe to assess new agricultural biotech innovations. Should we have a similar principle with human biotech innovations that requires some sort of demonstration that these innovations are "safe for society"? And then, what does "safe for society" mean?

How do we determine when a technology presents too great a threat to shared humanity? And these are terms that Frank mentioned in his materials as sort of general standards.

And then, also designing a review process is difficult. If we're going to assign these decisions to review groups, what should the composition be of the group? Which professions should be represented? And other kinds of experts.

If we are to include public representatives — and I do think we should — we would want to find people who are not intimidated by the experts and who can inject an independent voice. This has been a problem with IRBs who are supposed to include people like this, but it can be very difficult to find them.

We also need to recognize the cost of a good review system. I think as we are learning from our council experience, it's really tough to do justice to these kinds of activities and still keep your day job. So, again, this is one of the major problems with IRBs. Everybody has their "regular job" and is scrambling to devote enough time to this review responsibility.

So we have to think about where the resources will come from. An underfunded oversight system that looks great on paper won't have its desired effect if there's not enough money to pay for it.

And, finally, apart from this call to regulate, Frank argues for certain substantive restrictions on cloning and other biotechnology developments. At the same time, he recognizes that in the contemporary United States there are strong social pressures that favor scientific freedom, economic opportunity, reproductive choice, and improvements in health as well as quality of life.

In our democratic system, groups representing these interests will undoubtedly participate in designing the oversight system and, thus, the standards and structures are likely to take these interests into account.

My own view is that encouraging a thoughtful approach to regulation will require much better communication with the public about the technologies at issue. I think a major problem today is the failure of the media, industry, and scientific organizations to acknowledge how uncertain are the potential benefits of this technology, and also to place these developments in the context of a nation and a world that are struggling to meet basic health care needs of many people.

So, in sum, Frank's account has two elements. One is on the need for regulatory institutions, and one is on what he believes should be the desirable content of that regulation. It might not be difficult to reach agreement on the first element, but I think that substantial barriers to agreement on the second exist. And this is why I think a lot of times the institutions don't get created, because people can't agree on what even the general principles would be.

Despite all this, I do think the Council should take up Frank's charge and consider next steps. That is, what general principles should govern biotechnology research and use? And what would be the characteristics of an adequate regulatory system?

In one sense, I think our Council is a good test case. We're very diverse in our disciplines and our values, and, thus, if we can begin to answer these questions, perhaps other groups, our elected representatives, and other government officials can do so, too.


CHAIRMAN KASS: Rebecca, thank you very much.

Let me recognize Mary Ann and then Jim Wilson.

PROF. GLENDON: Well, I, too, am very grateful to Frank for opening up these questions of regulation and institutions, and to him for recognizing the political dimensions of the problems that we are going to be addressing. And so I would add my voice to those who encourage the Council to explore these matters further.

I think that the political discussion of regulation and institutions has to begin a step earlier with the question of priorities. I think my remarks in the last session might have been misunderstood by some of those who commented on the topic.

When I raised the question of allocation of scarce resources, I was not trying to make a point about equality, but, rather a point about priorities. And I think the beginning of wisdom in this area has got to be an investigation first of, what priorities has our society established already in the area of biomedical research and biomedical technology, either intentionally or by default? Where are we going? And then, is that really where we want to go? How are those priorities established? is a political question.

I would also suggest that as we explore those kinds of issues that we take account of the effects of a major demographic change on the politics of this whole question. I referred earlier to the aging of the baby boom, and I referred to it in the context of increasing demand for certain kinds of services that have a moral dimension.

But it has another effect. And if you look a little bit further down the line, the aging of the baby boom is causing a change in the ratio of active workers in the labor force to persons in the population who are dependent, retired and frail, elderly, very young, etcetera. That second change may very well have some very sinister implications, not only for enhancement but for other desires of the aging baby boom population.


Jim Wilson?

DR. WILSON: I will join in the praise for Frank, and I was especially impressed with Rebecca's very careful analysis of this. There are only a few points I can add.

My discontent with the conversation we had over the last hour — a discontent I am unable to mask because I lack sufficient control of my facial muscles —


— reflects the fact that we were not focusing on something concrete. It's not the job of this body to make rules about Ritalin or, to use an example I threw in, hand-held calculations. We're really concerned with the possibility of germ line strategies, and we must be very specific in our future deliberations in enumerating those things which are: a) sufficiently important, and b) sufficiently likely, so that we know what we may have to regulate.

And should the Council endorse cloning for biomedical research, we have to be clear about what regulatory mechanisms would be employed there. Although I think the Council will be divided on this issue, we should not pretend that the problem does not exist. So I think my first piece of advice is to the staff, let's be as focused as we can the next time we visit this question, so we can talk about these things in rather concrete detail.

Secondly, when we design or think about designing regulatory bodies, we must consult with the bodies to be regulated. That is to say, the membership of this Council need not be altered, but we must enter into some degree of informal consultation with people in biotechnology and others who are active in the field in order to understand what is happening.

One of the lessons I have learned after studying political science for 40 years is that the threat to the republic rises — is much greater when it arises from ignorance than from influence.

Our constitutional system and the courts that oversee it are well designed I think, by and large, to handle the excessive use of influence. But they're not at all skilled at handling ignorance, and we have to figure out how best to design something that will work in the practical world.

David Kessler's quote that Rebecca Dresser gave was to me an example of ignorance. In the view of many people for whom I have the greatest respect, it was, in fact, an example of duplicity when he made certain assumptions about silicon breast implants that medical science at that time had failed to support.

I think one way in which to make our efforts more focused and deliberate is for the staff, if Leon agrees, to gather information about what, if any, kinds of regulations govern or led to the creation of IVF clinics and IRBs, so that we'll have a clearer understanding of the factual or legal understandings that now govern those enterprises.

And my final remark — and I make it final because to me it's especially important — is that we must allow markets to operate in this business. We do not know enough. No regulatory body ever will know enough to manage these things. If germ line technologies are to be employed, obviously there must be some oversight as to which are appropriate and which are inappropriate.

But with respect to those that are appropriate, people must be allowed to make money doing this. Because if they're not allowed to make money, the appropriate germ line strategies will never be pursued, and people who might benefit from these strategies will never have the opportunity to do so.

CHAIRMAN KASS: Frank, did you want to join in?

PROF. FUKUYAMA: In response to that, I think there's a tremendous amount of work to be done. It was my intention, actually, in parallel with my service on this Council to, you know, get foundation funding to basically do a project, you know, that would look at biotech regulation that would do precisely that.

I mean, I have an ongoing study group that would call in regulators from the different agencies and simply to talk and inform ourselves about, you know, current problems. For example, I mean, and I think there's probably a lot of consensus that this needs to be done quite apart from the ethical concerns that we're supposed to address in this Council.

For example, you take the case of individualized medicine. The FDA, you know, as a result of completion of the human genome project — the FDA is going to have a huge problem in dealing with this, because you're talking about medicines that are individually tailored to, you know, particular genetic profiles for which the existing, you know, large clinical trial model is simply not appropriate.

And, in fact, Catherine yesterday was saying that, you know, if you extract a stem cell under her method, you know, by current FDA rules, you know, that has to be considered a separate — you know, a separate drug that would require separate FDA approval for every individual for whom you do it.

And, clearly, you know, that — there is something, you know, really wrong with that — you know, that model that needs to be, you know, I think very dramatically rethought. And so I think that, you know, one further point — I mean, since September 11th, there is a — unfortunately a security dimension to biomedical research that — in this country that I think we have not previously been — I mean, we've been conscious of, but there's a fellow that I know who is a former weapons inspector in Iraq, who is actually trying to — he now runs the Washington office of the International Institute of Strategic Studies, but he is trying to organize the global biotech industry to create a self-governance mechanism to prevent a big disaster.

He was quoting me this one example, that there is a private biotech firm in San Francisco that is trying to wrap a virus inside a bacteria in order to get the — you know, the virus past a person's immune system to obviously deliver a therapeutic, you know, vector. But, you know, obviously, it can be used as a bioweapon, and his particular concern was that they were actually subcontracting major parts of this research to a lab in the Ukraine.

And he was saying that, you know, nobody in Washington even understands, you know, the global biotech industry well enough to even realize that this is a potential problem. I mean, he said he was sure that there is nobody in the Defense Department that had any knowledge of this company and what it was doing.

So, you know, there is also I think that — you know, that dimension. And so I think, you know, for a whole variety of reasons, this is a question that needs to be looked at.

One issue that I actually had wanted to mention earlier, which is the question of democracy. You know, in general, when you deal with highly technical areas, like the regulation of biomedical research, what all democracies do is to delegate responsibility to that to, you know, so-called epistemic communities, and that's basically what this whole FDA system is and the self-regulation that goes on within the scientific community.

And that's, you know, absolutely necessary because, you know, there's a high entry price to even being able to have an intelligent opinion. You know, it depends on scientific knowledge and background, and so forth. And so — and that's the way a lot of the regulation has happened up until now.

I think the conceptual challenge is whether you can democratize in a certain way — I mean, I think that there are a number of reasons for thinking that that delegation is going to be more and more problematic as time goes on, simply because the technologies will do things that will raise ethical problems that people in the democratic — larger democratic society will have problems. Not everybody, but — and different people have different problems with different aspects of it, and there won't be complete consensus. But it'll be much more controversial.

And I think that the self-interest of the epistemic communities cannot be assumed to correspond to the interest of the society as a whole. That is to say, researchers have their own ambitions and goals. There is clearly a private biotech industry that's driven by, you know, its desire for, you know, profits, and so forth.

And so the question is: can you modify the governance structure such that it is not a pure delegation? Obviously, it has to be, you know, substantially delegated. But can you open it up to some greater degree of public participation? And here I want to divorce completely my own views of what that — you know, what the rules ought to be.

I mean, I'm just saying procedurally it seems to me that we need to think about whether there is a way of, you know, opening up that procedure and democratizing it to a greater extent, you know, and taking it a little bit out of the hands of the epistemic community to allow other societal voices to — you know, to participate.

And I think that there are some models for that. It's sometimes — when I've described this to people, they say very contemptuously, "What? You're going to have an ethics regulatory agency, and so forth?" But, in fact, you know, that is the idea behind the non-professional members of IRBs, that you get, you know, social voices that don't have the same set of interests that the biomedical research community does.

You know, the British agency also has similar rules for non — you know, professional membership in its oversight board. And so I think there are — you know, in democratic societies there are actually institutional models where you can, you know, broaden the kinds of societal inputs that — you know, that go into it.

Now, Rebecca may be perfectly right that given the deep — and, particularly, the closer this gets to abortion and, you know, embryos, and so forth, the harder it's going to be to come to any agreement whatsoever.

But I do think that, you know, and so it may not be possible to create these institutions, but I think, you know, generically that's what we're talking about. And then, there is some precedent for it, and so I think we ought to, you know, think carefully about what that might look like.

CHAIRMAN KASS: Michael? Then I'll join the queue myself. Michael Sandel?

PROF. SANDEL: Well, I appreciate very much Frank's project, and I find it all persuasive. One small request that I think would be helpful — Frank has referred to the U.K. licensing system, which applies to the full range of these, and I think it would be very helpful for the Council to — if there were a good account of that and what restrictions they've decided on that could be distributed, I think that would be a valuable thing for us to have, because there is a model out there — which we may or may not agree with in all of its aspects — but I think we should — it would be helpful if we could have a copy of it or an account of it.

The more general point, though, I would like to make is that it seems — it might seem as though Frank's emphasis on the regulatory aspects, and Rebecca's, is a separate topic from the moral and philosophical arguments we've been having.

But I think it's worth drawing out the — some important connections between the two, and to incorporate more explicitly some of the regulatory restrictions we might favor into the philosophical account, the discussion, even of the cloning issue, which we haven't really done so far.

We haven't gotten into — for example, here are two ways in which the discussions are connected. The slippery slope arguments that Charles and other — a few others have raised loomed large in the moral discussion about cloning for biomedical research.

And there are those who take seriously the worries that lie at the end of the slippery slope and also take seriously maybe even the tendencies that Charles emphasizes, but who may think there are practical ways through regulatory and licensing systems institutionally to prevent them. And if that's true or plausible, then that makes a difference for the argument about whether we ultimately endorse cloning for biomedical research or not.

Insofar as there are moral/prudential arguments, then some actual accounting of the prudential measures and licensing and regulatory measures is part of the moral argument itself, not just a further topic for a future report.

A second way in which these two are connected, the regulatory and the moral argument, goes to the — remember, we had these three categories, and group two were those people who kind of wrung their hands and had moral qualms, but nonetheless wanted to go forward. And it includes those people who in earlier discussions said there should be some respect accorded the blastocysts, even though some of us don't regard that as a full human person.

And then, the challenge comes from Gil and others rightly, well, what does it mean to accord some measure of respect if you're prepared to take it apart to kill it? How do you give actual institutional expression to the respect?

And here's another area where including discussion of the restraints that you might want to endorse and insist on, restraints having to do with the number of days, having to do with the purposes to which it could be put, having to do with whether the research could proceed if there are already existing stem cell lines of that kind out there or not, which the British case restricts, restrictions having to do with the requirement of depositing the stem cell lines in a pool rather than privatizing them, which I think the British one also includes.

It might be possible to make out an answer maybe not persuasive in the end to Gil, but at least a substantive, a more fully developed answer about how in practice people in category 2 would give concrete institutional, practical expression to the restraints and to the restrictions. And this would be a second area where spelling out the regulatory and licensing aspects would be part of the moral argument, not a further consideration to be dealt with in another report.

So I'm hoping that even in the report, which we don't have so far, on cloning for biomedical research, it's possible to try to spell out, even if in a provisional way, some of the regulatory restrictions that would be associated with what we've been calling position two, those people who take seriously the moral costs associated with sacrificing blastocysts. And, well, what does that mean in practice, and how does that differ from a view which would be indifferent to that moral dimension?

CHAIRMAN KASS: Thank you very much.

Let me make a couple of comments.

PROF. SANDEL: Could I add just one thing? The Senate debate completely ignores this. There it's either for or against. You're either for permitting the cloning for biomedical research or against, and one way this Council could make a contribution by linking those regulatory restrictions would be to show that there is another alternative.

CHAIRMAN KASS: Well, just — I didn't want to comment on that, but you — since you came a second time, let me make a small point. I mean, it does seem to me that thinking through the regulatory possibilities is part of the prudential judgment about what to do, though there is a kind of further question when one actually makes a recommendation of what to do as to whether one says there could be regulatory possibilities and, therefore, one judges this way, or one insists on being shown the regulatory possibilities in advance before one signs on morally to a particular position.

I mean, right — I mean, it's one thing to say there's a theoretical possibility that this could be regulated, and the British have done it, and another thing to say this country, given its industrial structure, its decentralized medical profession, its different view of how these freedoms should be exercised, could do this but may very likely not.

So, I mean, I take your point absolutely, and we come explicitly to the discussion of the public policy as opposed to the — I'm almost inclined to say merely moral considerations of this. The intersection of these two things I think should certainly be part of our deliberation and will be.

But let me speak more generally about the regulatory matter here. What appeals to me about Frank's suggestion, though, Rebecca's very well-stated cautions, and Jim's skepticism, and if Stephen Carter were here he would remind us always about how things wind up regulating against their original intent and worry about that.

Despite those worries, what inclines me to Frank's suggestion is this, that we meet in this room and our predecessors met in comparable rooms, and there will be other bodies like this to help people do their handwringing as the train goes forward.

But it's not clear that these considerations which are not merely abstract, philosophical ones, but are matters for the polity, for better and for worse, should find their room for expression in various kinds of decision-making, whether it be questions of funding priorities, whether it be the setting of certain kinds of boundaries within professional societies, whether it be governing the ethics of research, or what have you, whether it be at the Food and Drug Administration.

And as I see it, and we are trying to gather information, and at least the staff is slightly ahead of the Council, should the Council decide it wants to go forward here, we've at least been doing some spade work to try to find out what happened — what's going on in the FDA that might lend itself to the inclusion of considerations such as the ones we're developing here.

What is there going on in the Patent Office that affects the pace of this kind of research? What about the IRBs? And so we're trying to get background information and invite people maybe to prepare papers for us should we want to go forward on this area. But it does seem to me from where I sit that right now the larger considerations that bring us together do not have an adequate venue for consideration.

The FDA primarily had questions of safety. The Patent Office doesn't really care about even whether something has criminal uses, as long as it has legitimate uses, in deciding on its patents. And the IRBs, which are wonderful on the protection of human subjects of research, if you can't force the question into a sort of human subjects of research framework, you might not be able to get to the concerns that we have.

And the public presentation on those bodies is likely — is very often intimidated, and so on. So I don't think we — the existing structures are such that the considerations we're interested in can find adequate expression.

That's one point. So I think we — it's worthwhile thinking this through.

Second, to pick up something that Jim Wilson said about the importance of involving industry in these matters, what's really new in the 25 to 30 years since I've been thinking about this is we now have powerful groups for going forward, not just the scientists in their laboratories doing what they've always done, but these powerful commercial interests which are, for the most part, unregulated.

And my sense of this is that it is in the industry's interest — and we need to persuade them that it's in their interest — but I think it's in their interest, in fact, to join this conversation lest some of their cowboys produce the kind of disasters, the thalidomide or something of that sort, in which restrictions come down and response to disasters that will be terrible for them and terrible for us.

So we have begun to have some conversations to locate those kinds of people who could come and talk with us, and at least enter into some kind of conversation about what kinds of things they might willingly join in setting what kinds of boundaries.

And, in fact, one of the theoretical questions one wants to put to them, and we can test it out by putting it to our members here from the scientific community, is, can one begin to think constructively about the kinds of moral boundaries that researchers and technologists should observe, whether or not they take federal funds? In other words, whether they work in the private sector or not. And can one begin to think about this without threatening the goose that lays the golden eggs?

If the scientists are always saying that any attempt at regulation, or any kinds of restriction is simply threatening to our enterprise, then I think they also are in danger of running certain kinds of risk to their enterprise should disaster strike.

And it seems to me it's in everybody's interest to at least explore the question of whether we can find, if not substantive moral boundaries, at least procedures for considering these sorts of matters as the research goes forward, so that the larger considerations enter, so that the profit-makers are actually at the table, and that the working scientists contribute in a way that doesn't stifle the research but respects that the moral — the moral sensibilities of the community.

So if we can't do anything like that, then we — we will have a good time. We might produce some documents that people will read. But giving efficacy to these concerns where it really counts, I think we will just fail to do that. Whether we can succeed in this venture, I don't know. This is a high-gain, high-risk exploration, I think, because it's not clear we can — we know what to say at the end of this.

But because of its importance and its promise, I would be willing I think to invest our time and resources, if we could figure out just how to proceed in a practical sense. And it would at least help me, and I don't want to pin anybody down on this, but it would be interesting for me to hear — I hope for all of us to hear how the researchers in the group would respond to a request for a kind of inquiry on this.

So, Janet, and then Elizabeth, and Dan, if you will, too.

DR. ROWLEY: I have the impression, though I don't remember precisely, that, in fact, in one of the National Academy reports there was a suggestion that some kind of an advisory body or regulatory body could be established.

Now, I could be mispresenting that — remembering that from reading of another report. But I think that just as the individuals involved in recombinant DNA technology recognize both promise about the safety concerns in the early '70s, and established the RAC, I think so, too, many members of the present community involved in cloning also recognize many of the concerns and issues.

And particularly, because they are so much more directly related to people and the potential for uses than was clear in the '70s, that the biomedical community would — I would think, I would hope, would actually respond positively to the suggestion that they be involved in the development of a committee that would look at guidelines for these kinds of questions.

And I think that as well as looking to see what the British have done — because it isn't as though this is brand-new, others have done this as well — to look at other examples that have been successful. I noted that John Gearhart did also mention the Canadians and thought the Canadians had done even better than the Brits. So if we could ask staff to get information on that, I think that would be helpful.

And I would certainly agree with Frank and with Mike and others that in these committees that broad representation of other groups is certainly important.

In the National Institute for Human Genome Research, we have the ELSI Committee, which is the ethical and legal and moral implications of — I don't know whether the S stands for science or what, but anyhow it deals — social.

So that is already embedded in one of the NIH committees, and a proportion of the Genome Institute's research funds are earmarked for ELSI research, so that the genetics community at least has embraced the fact that what it does in the research arena is — should be viewed by communities other than just geneticists. And I think that that is appropriate.

While I have the microphone, I'd just like to go back to some of the comments that Mary Ann made, because she brought up the question of, what are our priorities? And it seemed to me the bottom line she said was these are politically dictated, and I — I wonder if, in fact, that is so.

You can say the priorities of where are we going are not determined by political forces, but, rather, by events that are driven by others, including scientists, engineers, etcetera, who come up with discoveries that then have an impact on society. And what society is doing is responding to these new areas and trying to figure out what kind of a response is appropriate rather than society saying, "We're going to go and do this kind of new thing." And so I would just question that.

CHAIRMAN KASS: Mary Ann, please, you want to respond?

PROF. GLENDON: Just a point of clarification. I didn't say they were politically dictated. I said it's a political question and something that we ought to understand as a starting point to what extent they are governed, as you say, by events — that is, by default, and to what extent there is intentionality.

CHAIRMAN KASS: Would you say another sentence? Because I'm not sure everybody understands — would understand what you mean by "it's a political question."

PROF. GLENDON: It's a political question whether a society likes the direction in which it is going, either by choice or by inadvertence. It's a subject for deliberation in a democratic polity.


Elizabeth, please.

DR. BLACKBURN: Yes. I really very much want to endorse what Janet just said. Leon used the phrase "all scientists" — I forget, but I think it's been very clear from the history that scientists have had a strong voice in wanting to self-regulate — the RAC being one example.

And to answer your — you said you wondered if there was something in the National Academy's recent report on — this was the report on stem cells and the future of regenerative medicine. Included in our handout were the first three chapters excerpted but not the last one, the findings. But I have the original with me, so it — let me read you the recommendations, which directly are pertinent to this.

So the recommendation after finding six was a national advisory group composed of outstanding researchers, ethicists, and other stakeholders should be established at NIH to oversee research on human embryonic stem cells. The group should include leading experts in the most current scientific knowledge relevant to stem cell research who can evaluate the technical merit of any proposed research on human embryonic stem cells.

The roles for the group could include evaluation of potential risks to research subjects and ensuring compliance with all legal requirements and ethical standards.

So I think that perhaps an implication that might have been taken from Leon's phrase of all researchers, which the scientists are not interested in self-regulation, I think that's — this is just manifestly arguing this is not the case, that there is serious interest in self-regulation.

CHAIRMAN KASS: Dan, please.

DR. FOSTER: Well, I think the idea of having industry involved here is a very good one for dialogue. Most of these — most of big pharma have ethical committees associated with them. But my view, Leon, would be in this dialogue that you probably ought to have somebody from big pharma that is not so much — they buy biotechnology, and so forth, but they're not as much in it as they are in the small start-up companies, and so forth.

So, I mean, I think that, you know, you get somebody from Tularec or Genetech or something like that as well to come in — would be very helpful to — both to let them hear what we had here and what their suggestions would be about that. So I personally think that would be a very good idea for us to do.


Mike, Alfonso, and Gil, please.

DR. GAZZANIGA: The shortest remark of this panel: I agree with Janet.


DR. GÓMEZ-LOBO: Yes. I want to voice a brief concern about the regulatory model which consists in appointing committees. And I'll just do it by mentioning the fact that some colleagues of mine, British moral philosophers, have serious doubts about the human fertilization and embryology agency, because, you know, who gets appointed there is really crucial.

And their criticism is that rarely, if at all, people who are known to stand for protection of embryonic life get appointed. So, I mean, it ends up being a kind of rubber stamp for a number of projects that are morally very questionable. So I think that's something to keep in mind.

CHAIRMAN KASS: Who was it? It was Gil and then Paul.

PROF. MEILAENDER: Actually, I think it was Paul and then Gil, but I'll go ahead of him again, as I did once before.

Two comments, the one very brief. It seems to me if we're going to pursue something along the lines that Frank has discussed seriously, we may need to set aside the language of self-regulation. That's just clearly not nuanced or sophisticated enough.

I mean, Frank talked about how you have to — you do have to delegate, to some degree, decisions to people presumed to have expert knowledge. But there are questions about how much you delegate, and so forth, and the language of self-regulation will not capture that I think, and we need different language.

The other thing I was going to say is just it relates to some things that worked their way through Rebecca's presentation responding to Frank. And, I mean, what he has done is really nice, but I just never know how to — what I myself think with respect to a certain kind of problem.

It just seems to me the conversation will proceed much more easily with some kinds of questions we might think about regulating than with others. And what I mean is we have fallen into a pattern in this country that isn't very satisfactory, but you understand why, with respect to certain kinds of questions, say ones that involve embryos, for instance, where we don't fund — we don't use government funds in a way that would implicate all of us in some way.

But we also don't say, well, no, you know, we're prohibiting it, and we allow private research to proceed. That leads to sort of a chaotic, not very satisfactory situation. On the other hand, it's rather understandable why we've gotten there.

And if we were going to fund and regulate, once law does that it confers a certain kind of legitimacy, and that creates its own set of problems, then. And I don't — I mean, I just — I have never quite — I don't like any of the alternatives. I have never quite figured out how to get past that problem.

It will be much more acute with some kinds of questions than others in terms of the range of issues that Frank has drawn up. But that problem of complicity that — the legitimacy that law confers is always going to be hard here.


DR. MCHUGH: I want to — I'm glad to follow after Gil always. But I also am pleased to follow after him now, because in relationship to what's being said about self-regulation, the — in the pharmacological and neuropharmacological realm, the largest organization in our country is the American College of Neuropsychopharmacology. And I'm the present sitting chairman of their Ethics Committee.

And I believe that it is a developing program in which issues that are problems are seen first, and then later dealt with. And I think the process and the willingness of such organizations is quite clear.

CHAIRMAN KASS: Well, I guess I'd like to underscore in part Gil's point on this, too. The professional self-regulation — there's a certain homogeneity of viewpoint as to at least what the domain is. This is quite apart from any particular vexing question such as the embryo-related questions would introduce.

But there is a certain kind of guilt mentality in those things in which the larger considerations that come out when you have a group of this sort talking don't generally get built into the conversation. I'm always surprised by what I hear about the table — that is to say, that very smart and thoughtful people interested in the same topic don't see it in the same way.

And if I simply hung out with, you know, the like-minded, professionally or otherwise, the questions just wouldn't look the same, and the industrial self-regulation, where all of these various institutions have their own ethics committees — I mean, it's — you get what you pay for very often in those places, and it's a very peculiar thing to have critics — it's like the company union very often.

And without impugning the judgments of anybody who works there, it is somewhat odd to bring in house people who, after the due wringing of hands, will endorse what the company is — the most profitable course.

Okay. And then, finally, the RAC is a wonderful but very limited example. It's limited by the fact that the question — this touches on something Frank said earlier. The question — the RAC grew out of the concern which led to the Asilomar Conference, in which, strangely enough, I think everybody saw that they were somehow in the beginning — at the threshold of the genomic age. The word didn't exist, but that this was the beginning of something very large.

There was anxiety about this very large thing. There were public critics of this very large thing. And all of the anxieties were allowed to be focused on the one question of the safety of the little recombinant organisms, should they get out of the lab.

And there were, of course, local threats in Cambridge, Massachusetts, etcetera, etcetera, that may have focused — but, once again, the question about the safety of the organisms, just as the safety of cloning, don't go to the heart of what it is that one actually is concerned about once the technologies are safe and ready for use. It's the use of the powers when they're safe rather than the hazards of making them safe.

And one of the things at the Asilomar Conference, several Soviet scientists were invited to this conference, and they sat in the front row and photographed all the slides. They didn't say a word.

And because the scientists, in their decency and naivete, thought that the only question under discussion was the safety of the microorganisms that were being engineered for use, no one paid any attention to the implications for possible bacteriological warfare that were implicit also in the kind of research.

But there were other people at that meeting who somehow understood the other implications. So it seems to me that these models that we have before us are interesting, they're appropriate for their place, but one has, I think, to renew the consideration in the light of our present circumstances — self-regulation, where possible, but with the input of — with the kind of input that's commensurate with the subject and with the stakeholders involved.

This is not, by the way, to suggest that the recommendation in the stem cell report would be inadequate. That wasn't meant to suggest otherwise.

Frank, and then maybe a couple of comments, and then we will move to — if there are others who want to — Charles, did you want in on this as well? Is that a light? No. Frank, and then —

PROF. FUKUYAMA: Well, just on the question of self-regulation, I wouldn't banish it from our lexicon, because it is, you know, a possible institutional model. And I think in, you know, the field of public policy there has been a lot of kind of theoretical work done on where self-regulation works and where you need more formal types of regulation.

And there's actually a lot of game theory behind this, because, you know, generally speaking, self-regulation works when communities are relatively small and homogeneous and, you know, where the kinds of issues that they're regulating, you know, don't pass a certain kind of threshold with regard to, you know, the politicization, and so forth.

So that, for example, in the standards world, there is just an amazing amount of self-regulation all over the world in terms of, you know, coming up with technical standards for all sorts of things. And this never reaches a political level, and it's all done, you know, pretty much by insiders.

But there are other situations where you have heterogeneous interests, where you have cultural differences, where you have national differences, where the issues are more inherently politicized, where these kinds of self-regulating informal mechanisms tend to work less well.

Just an example is the internet. The internet, when it was run by a bunch of engineers, could be completely self-regulating because they all agreed with each other. They all knew each other personally, and, you know, they could make decisions among themselves. But as the internet has gotten commercialized and more heterogeneous, that kind of solution tends to work less well.

So I just think — I mean, this is one of the — you know, but there's a lot of — there's a big body of thought, you know, that has gone into this more general question of when you can self-regulate and when that's not appropriate.

CHAIRMAN KASS: It looks like we may have exhausted this for today. Do I have the sense of the group that this is a topic to which we don't make a definite long-term commitment at this point, but we are interested in it enough to take it to the next stage, to gather the information about what's happening in Canada and in Britain in this particular area to invite in people from perhaps some of the bodies that already do practice regulatory activity in the area of biotechnology? And maybe set aside some time at the next or the meeting after next where we go into this more deeply?


DR. KRAUTHAMMER: We could also sort of think of it as we may not want to look at this as an issue to be spoken of in general, but to apply it to the specific questions as we come along. For example, when we get to deciding on policy for cloning, it would be appropriate to hear, for example, what Michael and others were talking about in terms of regulating from those who want to go ahead and continue to make it legal.

So I think it would — rather than speaking of it as a global issue, I'm grateful to Frank for introducing it, because we had really overlooked it. But to take it in pieces as we go along issue by issue, and then we'll — by the end of that, we may have some idea of what a larger regulatory structure would look like having examined a few examples of what it might do.



Let me ask the Council's consent to — if I'm not mistaken, we have three public comments on the list. Is that correct? Three?

Would Council — rather than take the scheduled break, and then reconvene, since we have I think public testimony from three people, could we take this now and then adjourn afterwards, since we're already together and we don't want to make lots of people sit extra time? If all these people are here. We did say it was going to be at 12:00.

So is Mo Woltering from the American Life League here? And is Richard Doerflinger here? And is Susan Poland here? Is that the right pronunciation.

MS. POLAND: Poland.

CHAIRMAN KASS: Poland? Would you mind going — if we began now? Then, let's go in that order. Mo Woltering of the American Life League, please step to the microphone. It's on.

MR. WOLTERING: I'd like to thank Dr. Kass and all the members of the Council for the opportunity to present these remarks. I'm the Director of Public Policy for American Life League.

My remarks today center around a very simple fact that's been scarcely mentioned in the discussions of this Council and even the larger national and international debate surrounding embryonic stem cell research and human cloning. However, I believe this fact has a profound significance for the discussion that is currently taking place.

The controversy surrounding embryonic stem cell research and human cloning eventually returns to the debate over the moral status and value of the human embryo.

And with this in mind, I would like to ask the Council to reflect for a moment on one simple fact: that human embryos are either boys or girls. This is an indisputable fact that's very seldom mentioned. The human embryo, from the very first moment of life as a single-celled embryo, is either a boy or a girl. That is, either a male or female.

Every high school student, in fact, learns this in biology class. One's sex is determined by chromosomes which are present at the very beginning of one's life as a single-celled creature. So I would ask you to keep in mind that when you are talking about human embryos you are talking about male and female human embryos. Knowing that every human embryo is either a boy or a girl adds an important perspective to the moral status and value of the human embryo.

One's sex is probably the most fundamental component of one's personal identity. And we know this when we reflect upon ourselves. We also know this when we reflect upon our everyday encounters. The sex of a person is the first thing we notice when we meet people on the street, and it's a major determinant of how we interact with people.

We will never be able to empirically confirm the presence of the soul, but we know that in order for a person to exist a living, human body must exist. And we know that human bodies essentially come in only two forms — male and female.

At the single-cell stage, we can identify a living male or female human body. At the most — one of the most fundamental components of personal identity is present at this very beginning stage of life. I believe that this alone is enough reason to recognize the personal rights of the human embryo.

So I think here we must be honest. Many are apprehensive about recognizing the rights of male and female human embryos.

As we all know, many widely accepted practices subject human embryos to death. Here I'm referring to the practices of IVF, embryonic stem cell research, even contraceptive practices which prevent the implantation of the embryo.

Clearly, if we were to boldly recognize the personal rights and the dignity of the human embryo, we must then reject all these practices that I have just mentioned.

The President's Council on Bioethics has a critical teaching opportunity here. History is filled with examples of societies that accepted a mistaken understanding of human dignity, and they allowed horrible crimes to take place against innocent people, yet people came together to correct those mistakes and to defend the dignity of the person.

You have a chance to lead Americans to a renewed understanding of human dignity, and I ask that you overcome all the apprehension. Human embryos are either boys or girls.

Thank you.

CHAIRMAN KASS: Thank you very much.

Richard Doerflinger, United States Conference of Catholic Bishops.

MR. DOERFLINGER: Thank you. I wasn't going to address the Council again, but when I saw such a short list I decided to help the members earn their per diems.

I want to begin by saying how honored I was to be given respectful attention by Dr. Outka in the session yesterday. I want to offer two clarifications on his description of my views there, however. He seems to attribute to me the view that there is no moral difference between destroying so-called spare embryos and specially creating embryos for research that will destroy them.

And he also says that John Robertson accepts my point on that in order to point to the opposite moral conclusion about both.

First, it was really Dr. Robertson's point to which I was responding. My paper was written as a response to Robertson's. But, more importantly, I don't think I've ever argued there's no moral difference between the two practices.

Obviously, I think the practice of specially creating embryos simply to destroy them for research is more morally abhorrent in more ways, just as it would be more horrific to conceive a child solely in order to abort her for organs than to abort in some other circumstances. My point is just that that does not mean the other abortions are morally right.

The point I was trying to make is this: there is often some measure of selfishness in our reasons for conceiving children, just as in our reasons for doing many other things. As a Catholic, I tend to attribute that to original sin.

For example, in having a child, I may have in the back of my mind that I would like this child to go to college and achieve things that I never did, to give myself some vicarious satisfaction. And in that sense, I am treating that child partly as a means.

But this becomes much more problematic if we are treating our offspring as mere means in ways that do them great harm for the benefit of others. And if we explore our reasons why so many of us, quite rightly, strongly object to creating embryos in order to do them harm for research, we will find in our feelings the roots of an argument that it is wrong to harm embryos generally. But I didn't equate the two practices.

Secondly, I wanted to comment briefly on the slippery slope. I wanted to confirm what Dr. Krauthammer said yesterday. During the debate on use of spare embryos in Congress, every member of Congress, every Senator, claimed to oppose specially creating embryos for research, by cloning or other means.

Outside research groups and patient advocacy groups declared the same ethical position, arguing, for example, that the Clinton guidelines on stem cell research kept this research within ethical limits precisely by excluding any involvement in special creation of embryos for research.

But when the debate switched to cloning for research, many of these Senators and outside groups immediately switched their position and endorsed what they had previously condemned.

I am tempted to agree with what Dr. Rowley said yesterday that this was not a slippery slope, that these people always knew where they wanted to go in the end. But that seems to suggest that they were simply being deceptive in their first position and raises the question why we should believe some of their claims now.

The rule "fool me once, shame on you; fool me twice, shame on me" seems to hold here. I do think there was a great deal of insincerity in the earlier claims to share moral concerns of the rest of us about specially creating.

My point is simply that I have no reason to believe that the slope does not extend further down. I want to raise two things about — does this stop with the embryo?

The latest bill, alternative bill to be introduced — and it has been called a compromise by its sponsors, S.2076 — does not, like some previous bills, ban the implantation of cloned embryos in the womb. It allows the implantation of cloned embryos in the womb, as long as that is not done for the purpose of "creating a cloned human being" by which I assume we mean a born human being or the bill would be incoherent.

In other words, this latest bill already endorsed by some Senators would allow implanting cloned embryos in the womb, to grow them to a certain stage of gestation at any time before birth, and then kill them for their organs.

The other reality is that when asked to proffer examples in animal models of what therapeutic claims can be made for therapeutic cloning, supporters have noted two studies. The first involves trying to make new kidney tissue for cows, but it required growing the cow embryos, the cloned cow embryos to fetal stage and then harvest their kidneys.

The second was an attempt to cure an immune deficiency in mice, and that did not work until they actually brought the embryo to live birth and then harvested its adult stem cells for treatment in the original mouse. In fact, there are no models at this point of therapeutic cloning that stays at the embryonic stage.

And I would like to offer for any Council members who are interested a document that offers a little snapshot of the advances that are being made now against some of these diseases without using any embryonic stem cells or cloning.

Thank you.

CHAIRMAN KASS: Thank you very much. If you'd give the documents to the staff table, we'll see that everybody receives these.

The last comment is from Susan Poland speaking as a private citizen. Ms. Poland, welcome.

MS. POLAND: Thank you. Mr. Chairman, members of the Council, my name is Susan Poland, and I work as a library researcher for the Bioethics Library at Georgetown University.

However, I am speaking only on myself and on behalf of no other entity. I'm also speaking from my experience as one of the first 10 women police officers in New Hampshire, and also as one of the first four lab techs in basic reproductive research at the Jones Institute in Norfolk, Virginia.

Recently, I co-authored a bibliography on cloning. Others I had done were on gene patenting and bioethics commissions. So I'm also speaking from what I learned from those.

And I have two basic insights, one comment on terminology, and then I'd like to really spend most of the comment time on illustrating what it was like to be, in 1985, a first-hand account of doing unregulated in vitro fertilization basic research.

First, a clone is a group of genetically identical offspring or progeny. It implies birth, and, therefore, I think that reproductive cloning is redundant, and therapeutic cloning is a misnomer and misleading, like gene therapy is. I would like to see you use the term "IVD" for in vitro division or duplication.

If you're going to have implantation into the uterus in hopes of a pregnancy, IVD/ET, just like IVF means in vitro fertilization, not necessarily followed by implantation, or IVF/ET.

My first comment or insight in working on the cloning bibliography is that the U.S. patent system is the most powerful and most unique law enforcement regulation that this particular government has for controlling research done abroad and in the U.S. You cannot really regulate the scientific research, but you can regulate and control access to the patent system.

And I was expecting or hoping that like you have IRBs or a super IRB for FDA, you would have something like RAC, because the patent system right now is overextended. It does over 10,000 patents applications in one year. It took over 40 years to reach the first 10,000 applications. Those people are not qualified, I believe, for adequately evaluating whether or not research is done correctly under bioethical principles.

Second insight — that was a short-term insight. A long-term insight is that the legacy, I believe, of this group will be its impact on human, and the definition of human to further councils and lawyers in the future, maybe not in my daughter's generation but the generation following that.

If you take a look at what's happening with cooperative robotics, autonomous robots that are making decisions, I wonder if we're going to define "human" as one cell, whether it's an embryo or what, and go back to the racist policies or miscegenation and one drop of blood.

And now I'd like to go into explaining what it was like to be a person that walks into a bioethic — excuse me, into a basic reproductive research laboratory with a background in law enforcement when you had a .38 Smith & Wesson on your hip, but you also had some experience with bioethics and the issues.

The first time I was there they looked at me like, well, are you going to stop the conversation talking about law, or are you going to just tell us what to do as a bioethicist? And I told them, "No, bioethics is not a badge."

Lawyers have — lawyers and policemen have judges. They give you a final decision. Bioethicists and theologians have no judge. And so the discussion continued, and they would talk, and it was a very small group. It was very similar to what I believe 19th century Britain was for discussing science.

We had close communications. I worked with Gary Hodgen, who you may know left NIH in 1984 because he could no longer do embryo research as a bureau chief. And the Joneses — Howard and George-Anna Jones had left Johns Hopkins sometime before because they were no longer allowed to teach because they had reached the age of 70.

So we were working with our small group. And, like I said, I was one of the first four. There were close ties to Patrick Steptoe and John Edwards in England. Everyone knew everything. This was in the age when there were no faxes. Well, they were relatively new. No cell phones, no internet. You were lucky to get things.

And at the time, in the U.S., what had happened with us doing basic research was a scarcity of materials. We were working basically with animals, and, when we could get them, human materials. But because of the fall of the Marcos regime, we were not allowed to get very many primates. They are very hard to get. And when you could find a monkey to work on, if you were using human material, just like with vaccines, three times of exposure to human hormonal material would immunize the monkey and you would no longer get valid results.

So, consequently, a good deal of research in IVF was done using the litter-bearing models of mice, which their ovaries do not react the same as, say, a singleton birth.

At the same time when we were sitting there, I remember one of the business meeting discussions like, well, what do you think? Do you think we should screen for AIDS? That seems to be a new disease. And you know what has happened since then.

I also sat in a meeting with Etienne Balieu, who was running Roussel-Uclef. We were doing work on RU-486 with one other woman. It was a small group of men and us two women. We were the only two people that thought we still agree with diaphragms, because we like control of our own bodies. Forget about giving us drugs that we can't shut out or whatever.

At the same time we were working with RU-486 on monkeys who were giving still birth, or the newborns would die relatively soon, Roussel-Uclef had signed an agreement with the Chinese government to test on people. When you have a policy of one birth or less, it's very easy to allow your people to go sterile.

Also, at the same time, in the summer of 1985, a professor named Akira Iritani, who is still in practice and still working today, came over. And it was sort of like the beginning of 2001 when you see the bone going up in the air from the cave man, and you see the space ship.

We had just gotten our first micromanipulator, a Japanese machine that Professor Iritani had used quite a bit. He had a graduate student, much like Briggs & King — King being the expertise for Briggs with all the insight. He had a graduate student when he showed us at the end of his term staying with us that could do two to three hundred embryos in an afternoon, splicing them, which we would call now embryo-splitting or blastomere separation.

And one of the slides at the very end was a picture of five identical goats born by an eight-cell embryo. And I thought my God, there you have the perfect drug testing system for a pharmaceutical company. I have as yet, as a professional researcher, to see anything in print. If you have any sway with people at the NIH, both at NLM and with research to get more Japanese work put out into the U.S. mainstream for people to know, that would be very nice.

China obviously takes one view based on a Confucian and socialist system, or a Communist system, rather, of human life. Japan takes a different view. Professor Iritani shocked even me when I discovered that in January this year he announced that his group and a different university is viewing genetic engineering — had actually inserted a spinach gene into a pig, and then produced two successive birth generations. From my Western mind, I don't mix plant and animal kingdoms.

And then, lastly, back in 1985, we were there watching what was happening in 1984 with the Medical Infertility Procedures Act when it was passed in Australia in Victoria. And the "hot dogs and cowboys" were going to be put in their place by the legislators.

Well, they certainly did. They emigrated to the U.S. as IVF Australia, became IVF America, and today they are now IntegreMed, Incorporated, responsible for one-sixth of all IVF births in the U.S., and our local outlet is Shady Grove Adventist Hospital.

So I feel that when Australia came into the U.S., what basically we lost was that very close-knit tie of research and clinical care, because it suddenly overwhelmed the system and it became just clinical care and consumers.

When I was working there in Norfolk doing basic research, we got human materials. There was a pecking order. Any human material was first used for patient care, and those people there would decide which ones were the best ones with the best opportunity of going on to help these people that wanted to have babies.

Anyone else would come second for research, mind you that not the best-looking embryos always were the best ones that went and implanting. So we had to rely on their judgment.

We did use cadaver eggs. I'm grateful for the one woman that did donate her ovarian tissue. But the eggs, of course, were dead, as I believe many of the 100,000 embryos are that are sitting around in the nitrogen tanks throughout the country.

But both groups, the clinical practice and basic research, were in service together on improving care. I've never seen such a group of remarkable people with high esprit de corps.

And there wasn't a feeling that this is a researcher-subject relationship or a doctor-patient relationship. We were more or less fiduciaries, trying to do best for individual people and yet also trying to do best for society by improving the science.

My own feelings about the moral evaluation of this, having been given the power to use my own judgment when I was 23 to use deadly force to kill a person if I had to, was that this wasn't destruction of embryos. This was actually loss. There was a real grief every time we had to kill an animal or lost an embryo that we just didn't work.

I'm sorry. Am I over my limit? Is that just some —

CHAIRMAN KASS: No, that's just some — that's just some —

MS. POLAND: Okay. And today I know that talk about the Human Embryology Authority and CCNE in France, while they have asked and joined Germany to put a ban through, or look at regulating human embryo research and, in particular, cloning, they also — the CCNE has asked the President to look at establishing its own authority like the HEFA.

They also use, by the way, the British term, which is cellular nuclear — cell nuclear — CNR. I'm sorry. Cell nuclear replacement I believe is what it is.

I was going to ask you, and then respectfully request, and actually I think the term I want is beg — beg you to regulate this. It was very scary to do IVF, which is fertilized or sexual reproduction, and now you're looking at in vitro asexual reproduction. To do it in an unregulated atmosphere because you didn't know what you were going to do, if you were going to hurt someone, and where the government would draw the line suddenly.

And that's about all I can do is ask — there's a balancing mechanism. My own — as I started to say, my own moral feelings about this, having been given deadly force, I have discovered have changed. And they evolve the more and more information I take in.

Thank you.

CHAIRMAN KASS: Thank you very much.

Did you want to say something, Janet?

DR. ROWLEY: I just wanted to correct Ms. Poland in terms of the definition of cloning, because cloning has been used in the biological community for many, many years. And its first use is — that I am aware of was really when you had a cell line, you knew that it was heterogeneous, and you wanted to take the cells in that cell line and begin new cell lines derived from a single cell, and that was called cloning.

So that, then, you had a homogeneous cell line derived from this heterogeneous cell line. So it in no way implies live birth.


Any comments? Could I ask — is Ms. Poland still here? Could I just ask, as a point of information, are you aware of — this is a question, too, as librarian. Are you aware of any overarching study on the practice of IVF along these lines? I mean, has there been any review studies that we — that —

MS. POLAND: On the safety of IVF?

CHAIRMAN KASS: No, not on the safety. Just on, in fact, the practice. I mean, you were talking really something about the unregulated character or the practice, the profession — the society has its own guidelines, which it has — which it has promulgated, and most of the members of that society abide by it. But there are also other groups that do this practice that are not members of the society. Is there any — are there any studies?

MS. POLAND: For clinical care, I'm not aware of any. And by the way, I did give Ms. Zwanziger one cite, which is the Hayflick 1965 cite, which relates to — it's a seminal article about the number of times you can actually reproduce a cell. It's supposed to be 50 generations, and I explained to her about checking to see if additional — but I can look into that if you'd like, if you can tell me later more —

CHAIRMAN KASS: We'll make the request more precise, and we might be in touch with you. Thank you very much.


CHAIRMAN KASS: Robby George, and then —

DR. GEORGE: Yes. Can I ask Richard Doerflinger a question?

CHAIRMAN KASS: Is Richard still here? Yes, please, Richard.

DR. GEORGE: Richard, since you're here, I thought I could get an answer to a question that frequently comes up, and it's this. Does the position of the Catholic Bishops Conference, or the Catholic Church generally, on the issue of the moral status of the embryo and what public policy ought to be on that depend on a view about the infusion of a spiritual soul in the early embryo?

MR. DOERFLINGER: No. There have been a lot of speculations during the course of Catholic history about ensoulment. Even during times when people thought they were pretty sure based on the biology of Aristotle and the philosophy of Thomas Aquinas that the early embryo was not ensouled, it still rejected abortion as an act that shows disrespect for this developing life that has a human destiny, that God is at the very least forming to prepare for a soul.

The current teaching is that abortion and destruction of embryos is wrong, first of all, because it destroys a living member of the human species, and that that's enough to deserve our respect.

And, secondly, that since we cannot be sure that the early embryo is not — does not have an immortal soul that when you are destroying that embryo you in addition risk the full gravity of killing a human person in the full sense. But ensoulment is not the factor that means the difference between moral right or wrong or even the difference between something that would be seen as an abortion as versus contraception. Is that —

DR. GEORGE: Yes, that answers it. Thank you.

CHAIRMAN KASS: Thank you very much.

Thank you all for your wonderful work, your endurance. The meeting is adjourned.

(Whereupon, at 12:18 p.m., the proceedings in the foregoing matter were adjourned.)

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