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Friday, July 12, 2002

Session 6: Agenda of the Council

Council Discussion

CHAIRMAN KASS: Could we return please and begin?

Frank, is the metaphysical group going to return?

This session is devoted to taking stock of where we are and beginning to talk about some future directions.

Just some general considerations, a reminder of some things that are at least under consideration, and then I think a free ranging discussion that would help us think and make plans for the future.

The first consideration, this Council by executive order is in existence till the end of November 2003. That's 16 months, something like that, and it's unlikely that we can do more than a couple of things and do them well.

So there are lots of things that would be worth doing, but we'd have to make some choices of more important and less important. And there are some things worth doing, but might not be worth doing by us, given our strengths and talents and the like.

Second, there is a consideration that for some people the issues that we should take up are things that bear upon immediate policy questions. There are other people who think that what's most important for a body like this to do is to lay the groundwork for various kinds of questions that might be coming and bring to public view certain important considerations that are insufficiently attended to.

Enhancement, for example, would be one such topic.

And I think we've learned from our experience over the last six months that it matters if you're trying to conduct a fundamental inquiry whether or not there is something else going on around you that has a kind of urgency in which there are various pressures brought to bear upon what we do.

This is a Bioethics Council, and as indicated at the start, ethics doesn't simply stop at the doorway to politics and policy. That has a deeply ethical dimension.

But we also have to be very careful as to whether or not we get caught up in things that are around us and simply respond to those kinds of pressures.

At the moment we have not been asked by the President to tackle any particular topic, though that could come. And I do know that that part of the executive order which asks the Council to explore the human and moral significance of things is taken seriously there. They're not necessarily simply interested in advice on this or that practical question, but with a view to this field as a whole and the fact that its issues will be with us for a long time, we do have the green light, I think, to find our way on the basis of what we think is either most urgent or of the greatest weight.

That, by way of some general considerations. I may have left out some others.

We have, as we were doing the cloning work, we have embarked on at least three other possible lines of inquiry. One was stem cell research, and we had yesterday our second — our fourth session on stem cells. We had the two presentations from the scientists, Dr. Gearhart and Dr. Verfaillie. We had Dr. Outka's presentation and discussion on the ethics of stem cell research, and yesterday Dr. Baldwin on the implementation of the policy.

We've had two sessions on enhancement, one prompted by the working paper of the staff, and then the one we had yesterday afternoon, and we've had under the broad heading of regulation, I think, four sessions, one, the general discussion prompted by the readings of the material that Frank provided from his own writings.

At the last meeting, two sessions with Lori Knowles and Dr. Baird on the international models, and then since we're treating the question of the patenting. Actually maybe I'm wrong. Maybe that's five sessions.

Well, we've had two sessions, several sessions on patenting, which does also deal with the general question of if not regulation, at least the interface between research or science and society applied not to this particular technology or the next, but to things in general.

Yesterday there was a discussion that suggested one might enlarge the patenting question either in two directions, one in the direction of science and commerce, the other in the direction of property and the body.

So there was the possibility of thinking about patenting by itself, patenting in relation or as an instance of and in relation to certain other things, and further questions developed along the lines of if one wanted to pursue the question of enhancement, to what extent is the sports example a useful instance?

Does one want to think about enhancement? And I don't know whether, Dan, your suggestion that we take up germ line modification was with a few to the question of enhancement or simply the question of remedying single gene mutations, but Dan had brought that up as well.

That is simply by way of reminder. I have a couple of thoughts myself, which I'll at least put out there. I would say that a bifurcation of our efforts, to think about maybe two large projects if we could figure out how to do them well might make sense. I'll simply speak for myself, but I'm really open to suggestion.

One, it's very nice to be liberated, I think, simply from the question of the ethics of the means and to try to think about some of the difficulties that come from where these powers are to be used.

And I don't like the distinction between therapy and enhancement as the best way into this subject, but that's onto something. If you go past the remedy for the treatment of individuals with known diseases, one has wandered out into unchartered territory. No previous council has ever really taken this matter up.

It is not an immediate policy question, to say that somebody is waiting to hear from us on this, but I think that in some way this might be the largest question where much of the greatest disquiet about what might be possible, and we could talk it through and maybe even address some of the disquiet and tone it down and also provide some ways of thinking about it.

So the use of these powers beyond therapy, I think, is one large area which would be unchartered and might be useful.

And the other large area has to do not with this or that particular moral question, but with the institutional questions. Ted Friedmann finished his talk yesterday with a kind of plea that we give some attention to what might replace these various ad hoc commissions that meet and talk. This has been Frank's talk from the day of the first meeting.

And that seems to be a way that at least in the majority recommendation talked about the importance of beginning to think through ways of surveying this entire field with a view to what might be done not just by way of commentary of advisory bodies, but for some institutions that could see to it that the large questions we carry about are even considered, monitored and perhaps even regulated for.

But that's at least where I would be inclined to start, but before we sort of broke for the summer, I thought it seemed to me we should hear from everyone and see whether we can formulate some useful plans between now and September when we come together.

So with that rather long-winded introduction, please. Mary Ann.

PROF. GLENDON: Well, on the enhancement/therapy topic, I would hope that if we choose to pursue that that we'll let it open out into the questions that are inevitably involved of allocation of resources, that is, allocation both of the human resource represented by scientific energy and creativity, but also allocation of scarce economic and medical resources.

CHAIRMAN KASS: Frank, please.

DR. FUKUYAMA: Well, I'm going to sound like a broken record on this, but, as your summary suggested, you know, my position has been fairly clear that I just think that councils like this are not going to have very much impact unless they try to concretely discuss ways of institutionally embodying, you know, ethical concerns into routine policy making.

And as the presentations on the HFEA in Britain, you know, last session, and the Canadian regulatory structure that they're putting in place indicated all of those bodies had their origins in a group like ours that issued very concrete, you know, a permanent oversight board that took into consideration ethical concerns.

And I think that all of these issues that we're talking about at a fairly abstract level having to do with enhancement, you know, versus therapy and so forth can be given a much more concrete focus if it is put in, you know, the context of, you know, actually institutions and how they would grapple with these sorts of problems, and I think that's one point.

The second point is if you look at the two in the majority and minority positions that we adopted or that are contained in our report yesterday, both of them make regulation central to, you know, their outcomes.

The first position says the moratorium, among other things, will be used to think through a regulatory structure.

Position two says we are not going to proceed with research cloning unless there's an adequate set of regulatory safeguards in place. So both of them, you know, push us to move down this road, and I would be loath to slough this off. In fact, in some of our discussions about the final report, I mean, there has been some suggestion that maybe there should be a separate, you know, commission or something to look at these issues.

And I feel quite strongly that that should be our duty, that we should really use the year and a half left in the life of the Council to look at this seriously.

And this does not preclude by any means, you know, ignoring any of the, you k now, ethical issues or have this rich kind of conversation that we had this morning, you k now, about specific issues, but I do think that it would help to focus the discussion very much if we looked at it in these very practical terms.

And, finally, I want to also endorse, you know, Dan's suggestion from yesterday that there is a very clear line that moves from cloning to preimplantation genetic diagnosis and screening ultimately to germ line, and all of those, I think, could be dealt with institutionally by the same institution.

I mean, if you set up a regulatory system to put some rules around embryonic cloning, that same institution will function to approve procedures in pre-implantation diagnosis, and it can also make rules for germ line, and so I think you will not only deal with the short term problem of how you proceed on cloning, but you will also set the foundations for issues that you can see either here, now, as in the case of pre-implantation diagnosis or over the horizon, you know, with the germ line, and you'll kill all three of those birds, you know, with a single stone.


DR. McHUGH: I want to second what Frank is saying and put it in another way. The appreciation of one group of ethics councils after another often turns on a discussion of various means that are employed presently in medicine.

And remember our Council is a Council on Bioethics, and therefore, ultimately should be talking about the ethics of ends, as well as the ethics of means, and I can tell you knowing ethics councils in various hospitals around the country, the issue of ends is very seldom their matter. They function very often accommodatively towards the culture within which it lives, and I believe that a regulatory body or a larger element of our country's government that is speaking now about these matters would deal with issues of means, broadly speaking in relationship to the things which Frank has mentioned, but would gradually develop a coherent discourse on ends that I think is necessary.

CHAIRMAN KASS: Let me ask on the — sorry. Gil? No, please, go ahead.

PROF. MEILAENDER: Just a couple of comments. One of the things I've thought about, and I'm uncertain about this, and it's undeveloped, but it seems to me at least I've begun to think there are some topics that you can deal with better in some settings than others. There are some topics that you can deal with well if you're teaching a class and you have a semester to kind of unfold the whole process of reasoning so that when you get here, you know, you refer back to all sorts of things that you've done and so forth.

We don't work in that way and meet in that way, and the enhancement topic worries me for that reason. I may just reflect my own difficulties with it. I just think it's a conceptual bog. I mean, I think it's very difficult really when you go to work on it.

You know, it's easy to talk about the distinction between therapy and enhancement. It's very hard to make it out in conceptually clear ways, and I just register the worry — it's no more than that — but the worry that we might trap ourselves in something that we can't dig our way out of in the kinds of meetings that we have.

I would rather see us take a piece of that topic if we wanted, and I mean, actually Charles had a number of meetings ago suggested germ line. When we had one of those sessions on enhancement, he had suggested that, and Dan has come to that.

In other words, if you focused on one little piece of it, of course, some of the larger conceptual questions would arise. You'd have to deal with them, but not as if you were writing the book that finally clarified the concept of enhancement, but you know, in the context of a particular thing.

I just have this strong feeling that we might have more success if we approached a topic like that in that way. So that, on the enhancement topic.

With respect to the regulation topic, not as close to my heart as to Frank's, but it's fine. I have no objection to it.

There, again, I think a discussion might be most fruitful if it weren't a discussion in the abstract or were a discussion of a proposal perhaps formed by even a subcommittee of this body or something like that rather than just sort of flailing around thinking about regulations so that we could see what a proposal might look like and begin to think more fruitfully about it.

Because I think there are some serious questions about exactly what kind of a regulatory body one would want, whether or how responsive to citizens we wanted it to be, for instance, and so forth that I'd want to pursue at any rate.

And then finally, I want to say I have thought for some time — I mean, it's not on your list and I guess it's not on anybody's list right now — but I actually think that the whole issue of organ donation, transplantation, sale of organs, which there's been a lot of stuff coming back about just recently again is a very important topic.

There's a lot to be learned about what actually goes on in the industry. It opens up into some of those wider questions that people were interested in yesterday, but it still remains. You can keep it focused on a question like sale of organs, for instance, which implies all of those issues about the commodification.

I just think that it's that kind of topic anyway that it seems to me that we're looking for that can be focused and narrowed while it still has the broader implications, but I don't think we're going to write the book about the broader implications on any of these.

CHAIRMAN KASS: Well, let me ask just to get clarified on this topic of germ line modification. What does it actually mean to the people we're talking about? What are we talking about here? What's the recommendation for this as something that we should take up?

Could someone specify what this slogan means? What is it?

Maybe I should ask Dan what he had in mind when he suggested it was the natural–

DR. FOSTER: Well, I think that if you look at gene therapy, there's very little controversy in terms of, let's say, therapeutic somatic cell therapy. In other words, as Ted was talking about yesterday, you know, you have a disease, adenosine deaminase deficiency, and you've got a severe combined immunodeficiency disease where the person has to live in a bubble or something like that; that you can treat the one patient.

We've been doing it by injecting the enzyme, but now it looks like there's been a repair which is genetic. So that only affects that one person. It changes that one person's life and has no implications for further generations, either good or bad.

But on the other hand, if you have a defect which is not a polygenic defect, like sickle cell anemia, for example, and you decide, well, we'll just wipe this out by correcting this in the gonads of carriers of the gene, then that has, unless this dies out in some sense, that has implications in perpetuity, and you know, there's a sense that somehow in evolution the sickle cell gene occurred to protect against malaria because malaria, you know, was the widest cause of acute death.

And even though this gave you painful crises and constant anemia, that was better than dying acutely. Nature said this is better than dying acutely. So in one sense, because in African Americans this is a terrible, terrible disease, you'd say, "Let's wipe it out."

But then, on the other hand, you might have to think about, well, are we going to then have resistant malaria, and so we're going to wipe out Africa not just through AIDS, but through malaria, in other words.

So there are implications of passing this down that I think we have to look at, and I think that I have concerns about some of this. So that's what the thing is.

I mean, gene therapy has some acute dangers. If you give too much of the virus, like the Philadelphia experiment and so forth, you can kill somebody, and it might be in an individual because genes talk to each other that putting in and repairing one gene defect, cystic fibrosis or whatever, that it might have effects to bring out or to, you know, other genes.

But it's at least in one person, and the risk is limited to that.

Now, you could also look at the germ line enhancement theories. I mean, I think Janet's point is that intelligence and things of that sort are so complicated that it's not likely to be realistic in the short run, but that's the general thing, that a single gene therapy is good or possibly bad for a single person, but does not implicate the race or something like that.

CHAIRMAN KASS: Is this — again, just for the record, these are speculative possibilities that people have talked about, but if someone where to say, "Well, look. We have pre-implantation genetic diagnosis." That's something else, right? That affects the individual that's there and gets us into some of the usual kinds of questions.

But how realistic and how likely is it that we're going to see, let's say, in the next decade or even two any serious attempts at human germ line modification?

Anybody interested in doing this? And who would give them permission? I mean, Janet, do you have some — what would you say?

DR. ROWLEY: Well, I've expressed my views several times, both in the media and outside of it, that I think this is extremely unlikely that we will have effective germ line gene therapy that we would then have to worry about in terms of its impact on both society, on individual children who might undergo such treatment, and that there are certainly other issues that are I would have thought more pressing than this, and even to take up Dan's view.

So, you know, you think about gonadal treatment of someone who's a carrier of sickle cell disease, and then you try to think, well, how would you do that, and you know, you replace all of the oocytes in the female or all of the spermatogonia in a male, and if you don't replace them all, then there is a certain probability that the defective sperm or defective egg would actually be the one that would give rise to an offspring.

So I mean, I think this is so unlikely that we would be wise to wait on a topic like this until it became more of a reality.

CHAIRMAN KASS: Bill and then Frank.

DR. KRAUTHAMMER: Could I make a response to that? Is that on the same subject?


DR. KRAUTHAMMER: Germ line therapy would be a subset of enhancement. It's serious, permanent enhancement, and if it's assigned to fiction right now, and I defer to Janet on this, I still think we could contribute to the question for the future by looking at enhancement that can be done now, which is non-germ line, which could be pharmacological as we discussed yesterday.

In other words, as you said, Leon, no one has really seriously looked at enhancement, and we could contribute to the future debate about germ line by focusing on the current debate about doable enhancement through drugs and other means or somatic genetic therapies.

So I think that would be a way to go about it. We wouldn't have to focus on germ line, but the implications would be obvious and clear for whenever it became doable and necessary.

CHAIRMAN KASS: I'm not sure, by the way, Charles, that I would say that if I understood what Dan was saying that you would want to describe germ line gene therapy as enhancement. You would rather treat it as very sophisticated preventive medicine, right?

DR. KRAUTHAMMER: Well, but I don't think that would trouble — well, perhaps it would, right.

CHAIRMAN KASS: Well, it troubles Dan because it's —

DR. KRAUTHAMMER: But not for ethical reasons. For safety reasons.

CHAIRMAN KASS: But those are, as I reminded weeks ago —

DR. KRAUTHAMMER: No, I understand.

CHAIRMAN KASS: — it's an ethical question whether you would —

DR. KRAUTHAMMER: It is, but —

CHAIRMAN KASS: — inflict this on generations to come when you don't know what you're doing.

DR. KRAUTHAMMER: But it is less interesting because the answers are much more obvious. If you can do a lot of harm for eternity, you probably don't want to do something. So in terms of therapy, I think it's one thing. In terms of doing it for enhancement, I think it makes it all the more difficult an issue.

But I don't see why we have to focus on that if it is going to be so speculative. We should focus on what is doable today.

CHAIRMAN KASS: Bill and then Michael and then Rebecca.

DR. HURLBUT: Well, just one little thought on this. There is a practical dimension to our asking this fundamental question of how doable is germ line enhancement or even therapy at this point. There's quite a lot of discussion in the popular press and serious books, such as one with a title that includes "post-humans," have been written on this subject, and I think it would be a service to our society if we were to take the insight that Janet has mentioned that a lot of our images of how genetics work are simplistic based on simple Mendelian models, based on simplistic notions of disease, genetic disease, not acknowledging there are actually syndromes, that there's pleiotropy, which means — for those of you not scientifically trained, pleiotropy means one gene does many things in the body. It's not a one-to-one correspondence between genes and traits, and polygenic inheritance, which means that most traits result from many genes operating together.

If we could acknowledge those two facts, bring them out into the context of the discussion and make a limited report to the public on the realistic possibilities and concerns on this issue, we would at least do a service to the general level journalistic discussion and maybe help keep science from a bit of bad press.

I think there's a practical dimension that I think the scientific community doesn't take seriously enough in America, and that is the degree to which the popular mind can turn against science. And look what's happened in England with genetically modified organisms. It's a significant social factor.

I suggest that we might want to think about for this issue and maybe several others, that we should request of the National Academies of Science some kind of reports on a few of the scientific groundings of the ethical issues we want to discuss.

Perhaps we should ask them to give us a report on what the realistic possibilities are for germ line modification and then on to the question of whether human beings could realistically enhance themselves.

CHAIRMAN KASS: By the way, one other general consideration I should have mentioned at the start and it's pertinent here is that one of the other things that should govern our choices is whether there are other people and groups even better situated and actively involved in this.

And I do know that some of these questions are part of the thinking for the next phase of the genome project, and particularly the ethics component of this.

So that's not to say that we shouldn't do this, but we should find out certainly how they plan to proceed along these lines, and I wouldn't be surprised — are you not active there, as well, Rebecca?

Yeah, maybe when you get the — do you want to speak first?

PROF. DRESSER: Sure. Actually, there have been some really good reports done recently on this. Well, I think they're good. AAAS has done a report on germ line interventions, and there's a book that I think is coming out this fall by people in that project. That's a very good resource.

The RAC did an excellent report on prenatal genetic modification where they explore some of these questions, and it's really great science. I think that was '97.

So those would both be good things to look at.

I think another thing that affects my thinking on this is that I think we made an implied promise in our report to address some aspects of reprogenetics, and I feel some obligation to do that. Maybe it doesn't have to be the next thing, but this morning I tried to make a little outline of what an enhancement project might look like, and maybe we could talk about a few different contexts: the pharmacology, pre-implantation genetic diagnosis, and then germ line.

I mean, there's a little bit of a progression there. One of the people say the allegation is that the demand for germ line modifications will be enhancement because if you're focusing on single gene diseases, pre-implantation genetic diagnosis in almost all cases will provide a way to avoid having an affected child, and you can still have a biologic child.

So the notion is that the real market will be in enhancements, and then that would bring in an opportunity to talk about commercial pressures and industry influence and that sort of thing.

So perhaps to meet Gil's concerns, focus on two or three kinds of practices, one that goes on today, one that, pre-implantation genetic diagnosis, goes on today, but it's still fairly new and it will be expanding in terms of conditions that will be the potential justification for performing it, and then a future oriented practice where people don't have their established positions, and there aren't as many stakeholers. So it's easier, perhaps to influence future policy.

And I think I agree with Bill. It would serve an important education function because I do think there's an extreme amount of misinformation out there about the possibilities.

And then there could be an ethical analysis of, you know, the concept of enhancement and using those particular practices as the focus and try to expand that analysis beyond what exists in the literature now.

We were talking last night about trying to take a virtue based analysis approach to this. That would be a little bit different from what's been done.

And then you could look at policy and regulatory approaches. You could talk about — I think professional regulation is going to be an important part of any judgments, you know, restraint in terms of how these things are used.

Individual judgments, how to try to influence the decisions that people make about when this is appropriate to use. Even insurance company reimbursement, what should be covered, and then some sort of regulatory agency that perhaps should influence policy.

So it might be a vehicle to try to address some of the other topics that we're also concerned about, and make it a little more focused.

What the genome people are doing now is they're just trying to put together their five-year plan, and they are discussing the material they will put out in terms of grants, the requests for proposals and the ELSI program, the ethical, legal and social implications program invites grant proposals in those areas. So they're not doing a project. They're just saying these are the kinds of things we're interested in, and individuals may decide to do projects on this, but I don't think that they'll be working through these issues in the way that we would.

CHAIRMAN KASS: Thank you very much. I have Michael and then Frank. Please, Michael.

PROF. SANDEL: I think we have three topics here, and as far as major projects, it seems we have time to do two major projects, but there may be a way to give attention to all three, and so here I have a concrete suggestion.

On the question of coming up with a proposal for a regulatory system that would be institutionalized, it seems to me that's something that this Council can develop, but I don't think it's the kind of topic that lends itself to the kind of free ranging ethical inquiry of the kind that we have had and that we're really constituted to engage in.

There are a small number of our colleagues who are experts in this area, which is really to do with the details of institutional and structural regulation. There are broad, normative questions, and Gil mentioned the question of how democratically accountable.

But what I propose we do there since it doesn't lend itself to sustained kind of ethical discussion is to have the people who are experts in that, namely, Frank and Jim Wilson and Rebecca, work with the staff to develop a proposal, a concrete proposal for a regulatory structure, and to devote a session to it here to discuss it.

But the developing of the proposal is not really something that we as a body are that well equipped to do. Let the people who are experts in that come up with a proposal, a concrete suggestion. Let's devote a session to it, and we may find that that's all we need or if we need to follow up, then that's always open to us.

That would enable us to devote our attention to the two big ethical questions that are really on the horizon and that we are equipped as a body to do.

One of the things that this Bioethics Council is able and ready to do really is to address, as you said, Leon, not just the bioethics of ends — of means, but also of ends, and that's really the distinctive contribution that this group can make. And that suggests two topics.

One is enhancement. And I think we can do that because if we ignore enhancement, really we're ignoring the central question about the ends of medicine and science that's before the country now and in the next decades.

I think we can address it in a way that makes it manageable, and I liked Rebecca's suggestion that we divide it into three parts: drugs, pre-implantation diagnosis, and genes, genetic interventions.

And I think we can do that if we take those three categories, do it in a way, and it will help keep us from veering off into the science fiction aspects, but the moral — the ethical questions about the ends are going to overlap those three categories, and I think that would be a fascinating discussion, but also really initiate a public debate on this question that is looming larger than any other if we're talking about the ends of science and medicine.

And then the second, which also has to do with ends, has to do with property in the body and commerce in the body. We don't need to take commodification as a whole, but if we focus on commerce and property in the body, we can do it with two categories.

One can be patenting. What should be patentable subject matter? And the other can be market exchange. What should be bought and sold?

I think we should deal with both of those, not just one of them because the issues will cut across both, and we can take up those two sets of questions under property in the body with respect to organs and also genes and eggs and sperms and stem cell lines, and maybe there are some others.

The issues may vary as we look to one or another of those categories, but that's, I think, the kind of debate that we're equipped to engage in and the kind of debate that's addressing really the question before the country.

So I think we should go with our strengths and with the questions that are really looming largest, and that would be enhancement number one, property and the body, number two. And we can do regulation, so to speak, on the side.

CHAIRMAN KASS: Response? There's a kind of specific proposal here that needs reaction. So Janet.

DR. ROWLEY: Well, I obviously have great concerns about dealing with a topic that calls itself enhancement. I do want to take exception to Michael's description of medicine as focusing on enhancement because I view medicine as focusing on the treatment and prevention of disease.

Now, to that extent that you call that enhancement, but that's not what the general population means by enhancement.

PROF. SANDEL: No, I agree with Janet, and if I gave that impression, that isn't what I was suggesting.


PROF. SANDEL: I was saying that we should focus on what the ends of medicine are not to be, and I wasn't equating —

DR. ROWLEY: Okay. Well, then I misunderstood. But I guess faced with choosing between your two suggestions in terms of, say, priority because they shouldn't be taken up simultaneously, I would be in favor of the second of your options and maybe putting the first one aside for further discussion and consideration.


DR. HURLBUT: I just want to respond to that. I completely agree with you that medicine is about healing, but let's face it. It's getting very hard to define what healing is in this day and age. I think more and more people are turning to medicine with expectations of the metaphor more of liberation from everything that is not just disorder, but is constraining to life.

I mean, if you look at — I hate to bring this up again. Leon might frown — but contraception set a new paradigm for medicine a few decades ago as interfering in natural life connections. Now, good or bad, that's not the point.

The point is that is was a change of paradigm, and that is about to echo forward in all sorts of levels as we gain mastery over biology to where medicine will become used for achieving the purposes that people think is in the trajectory of their life expectations or desires or ambitions.

I think we shouldn't underestimate that, and one of the things, Rebecca gave an order of topics and it started with drugs. I think maybe it would be better to go pre-implantation diagnosis, genetic enhancement, cellular enhancement, and then drugs.

But the reason I say that is because we are at the cusp of an astonishing revolution in pharmacology, and particularly I think Paul will back me up on this, psychopharmacology. We have now capabilities for combinatorial chemistry that are synthesizing and screening drugs by the hundreds of thousands in a month where it would have taken ten years to do the same amount a few decades ago, and the number of protein targets that the genome project is revealing to us on which we can target pharmaceutical agents is increasing exponentially.

It's said that up to now we've had 400 to 500 protein targets. These are the operative sites that our pharmaceuticals operate on, most of them. We've got only four or 500. Now we're adding some people estimate 1,000 a year and expect to increase that by 1,000 a year for ten years.

Now, you can see how that would be an exponential number of sites of intervention. So we're looking at a transformed medicine, I think, and I agree with Michael. We need to get to these issues. The public is thinking about them, and they are to some extent realistic.

By the way, half of those pharmaceuticals being developed are psychopharmaceuticals.


DR. McHUGH: Well, I found this conversation between the four of you on the other side extremely useful along the lines that I also said at the beginning, that we need to move towards a study of the ethics of ends, and I pick up with Janet and Gil and appreciate the problem of the enhancement arena simply because the arena goes at a level beyond disease.

I talked to you at the beginning of this about the elements of treatments that are involved in the treatment of behavior, treatment of personality and even treatment of the story of a person's life itself, each one of which medicine has a place to play in, but makes the problem that Gil first said he worried about, that we might lose our focus.

On the other hand, I think I absolutely agree with Michael that this is a vital arena for us to study, and so I would like to suggest to go along with what Janet is saying that maybe it would be good for us simply to get our further feet wet into this, to begin with the issues of property and the role of the body, the issues of the body, the things that we, as Michael said, trade in the body and even do to the body because we say it belongs to us.

And after that, as we got that kind of experience of discussing these things, then we could turn to the issues of enhancement in much the way it's been said here, and I think we would just be a better prepared group to come to that.

But these are the two domains that I would support us to go in as absolutely correct. I very much support that.

I do though want to say with Michael that even though it might only take a session or two on what would constitute a proper regulatory body, I think we will have left people believing that we have not let the other shoe drop since we've been saying, all of us, saying that this regulatory body is necessary, and that in that way we would not only be speaking to ourselves, but speaking to the scientific community that could come to us and support us from their suggestions as to what they would be willing to live with in regulatory terms.

So I think all I'm doing is repeating what's been said by the four of you on the other side, but I want to appreciate the concerns that you show and the sequences that we would follow would be maturing for us as a discussant group.

CHAIRMAN KASS: Thank you. Charles.

DR. KRAUTHAMMER: I like the scheme that Michael outlined. I'm troubled by one part of it though, as I have been by Frank's descriptions of the regulation.

I'm all for regulation, and I'm all for establishing a regulatory structure, but it begs the question what are we going to regulate which is a huge issue. I mean it sort of encompasses everything that we're talking about.

So it's not as if it's just a technical question. I think the technical question obviously is doable. A subcommittee working with staff would be a great idea, and I don't think there'd be a lot of discussion. People know what regulatory structures work, which ones haven't. There's history on this.

But the real issue in regulation is what are you going to regulate. We just spent six months on whether or not and how to regulate cloning, which is one issue out of hundreds.

So I'm not sure it will advance us a lot if all that we establish is a chart with the lines of authority. We'd have to discuss what's going to be regulated and to what extent.

So I think in other words, I'm not sure it's disposable unless it's a merely technical issue of establishing a body. If it's larger than that, it's a topic that could consume us for 18 months.

PROF. SANDEL: But that might be a reason to have them do the technical work and then address the thing after we do these two topics having to do with ends.

DR. KRAUTHAMMER: But it's not clear that you can do a generic box structure and then apply it to whatever you decide you're going to regulate later. It's sort of chicken and egg here, and I'm not sure how you go ahead with it.

Perhaps the regulation part ought to be the last thing that we do at the end of our term when we've looked at what we decide has to be regulated.


DR. KRAUTHAMMER: Cloning and sale of organs and patenting and gene enhancement or whatever enhancements, and then say, well, these are the new issues of the new medicine. Here's the structure and here's how it would do it.

Does that sound okay to you, Frank?

CHAIRMAN KASS: Well, Frank, go ahead.

DR. FUKUYAMA: Well, I think what Michael said is perfectly right. I don't think this Council can just take up this issue without any preparation, and so actually my thought was that the extremely able staff of the Council, which was able to come up with this thick report on cloning in six months could come up with, you know a similar draft document that wouldn't just deal with a narrow technical issue, but would actually lay out a series of choices in terms of regulatory options.

For example, do you want to just regulate cloning or do you want to spread it to regulate the whole of IVF and, you know, reproductive medicine in general?

I mean, so there are a lot of choices that the staff does not have to take a position on, but at least those kinds of choices could be made.

And I would agree that, you know, the way I would envision this is that, you know, the staff go to work. I'm happy to work with them. I'm sure Rebecca and Jim Wilson will as well.

I'm trying to get foundation support to basically be working on this, you know, to mobilize a bunch of people to work on this here in Washington anyhow in the next couple of years, and to come back in maybe nine months with a draft document.

But I guess what I don't want is just that it be one of these tabs, you know, in one of the briefing books that we discuss for one session. I mean, what I imagine is that it will be like the cloning report. I mean it will be another major, you know, kind of product that will come out of this Council toward the end of its existence.

PROF. SANDEL: Then for the reason Charles raises we have to discuss the ethics of each of the practices that would be subject to the regulation, which suggests it should be at the tail end of this because we won't have delved into all of those topics.

CHAIRMAN KASS: Yes, and there's, first of all, the subject matter question, and there's also a question of if one wants to offer suggestions that might, in fact, be taken seriously. One really has to be dealing and having a fair amount of input from the people whose activities one is threatening to regulate, and that means, in part, the scientific community, but it also means the industry because the academic scientific community regulates itself in a variety of ways.

And that means if one wants to try to be helpful here, one really has to think about arrangements that would produce the incentives for everybody to play rather than to treat this as police work. That's not a modest undertaking for, you know, armchair guessing. That means sitting down with people and doing it thoroughly and carefully.

It can't come out as the end product without an awful lot of work in advance. The importance of it I recognize, but one needs to go — even to get started on it, one needs, you know, a serious working document on what it would mean to do this right and not simply to call for doing it without having sort of laid that out.

And I'm not sure that the staff at the moment has the expertise in this area. The staff has a willingness in this area, but it would have to be if we were going to do this, either we would have to go and get some particular additional staff to work on this or we would constitute a subcommittee of the Council that staff could assist in the preparation of something like that.

But unless I misunderstand our resources, you can't simply say, "Go and design alternatives that we can then talk about." I mean I think you really have to — I mean, I'm not telling you anything you don't know.

You're setting up a year long or two year long intense study of this for that reason, and maybe we could work with you in that group.

PROF. SANDEL: Yeah, some of this could be done in the work of Frank's group, and then you could connect it to the staff.

CHAIRMAN KASS: Yeah. Gil. We're going to bring this to a close because I don't want to keep the public session waiting.

Please, Gil, go ahead.

PROF. MEILAENDER: Yeah, well, I just note with respect to this, I mean, it's not impossible for a body like this to commission work —

CHAIRMAN KASS: Absolutely.

PROF. MEILAENDER: — from others, too. I mean, so it doesn't have to be a subcommittee of us or the staff. We can do that.

The larger point, I still would like us to think — I'm not sure that I have the same — let me put it this way. I'm not sure that I have the same notion of what we're best equipped to do. I have to say the last six months has been a sobering experience in that regard, and I think we should think about that.

I mean, we tried to study and speak almost simultaneously in the last six months. We were talking and writing at the same time. I would just like somebody, you or somebody, Leon, to think about whether that's really the best way to proceed.

And I'm not persuaded that it is. That's all, and to start on another big project that we did the same way, well, I would just want us to think about that before we did it.

CHAIRMAN KASS: A couple of comments, and then we'll — Charles.

DR. KRAUTHAMMER: I was just asking what's the alternative to studying and speaking?

PROF. MEILAENDER: The alternative is to study for — I mean, one can study for a long time before one tries to speak or one can say at the outset, "This is what we're going to speak about. Now let's do it."

You see, you can either think you know from the start what you want to say and then, as it were, "write" to it, or you can be entirely agnostic about what you want to say and just wait to see what emerges.

And I'm not sure that one or the other of those might not work better for a body like this.

CHAIRMAN KASS: Alfonso — do you want to respond directly to this?

PROF. GLENDON: If I might.


PROF. GLENDON: Unfortunately I'm going to have to leave, and I do apologize for that, but I did want to say that I find myself in some confusion after having listened to the comments, and I'm mindful of the fact that we won't meet again for two months.


PROF. GLENDON: And I personally would benefit if we could have an exchange of e-mails, if we could send in our thoughts.

CHAIRMAN KASS: You read my mind. That was going to be the suggestion.

This is an inconclusive conversation. There's lots here, but because I might forget after Alfonso speaks, an assignment, please. Follow up on this conversation from as many of you as can do this in the next couple of weeks, if we could have your thoughts about future directions, with the understanding, of course, that people think about things that happen in the meeting afterwards and might come to a different conclusion having thought about it.

So please —

PROF. SANDEL: Could I just say a quick word of reply to Gil about the virtues of studying and speaking at the same time? I think that the discussion now — Gil may feel that I should have studied more before speaking, but I think that part of the exploratory quality in the animation of the sessions we had reflected the virtues of studying and speaking and exploring even before we had sort of necessarily taken positions or thought things through completely.

And so I think there is some energy in that kind of deliberation that I think has been a strength of the group.

CHAIRMAN KASS: Thank you. Alfonso, and then we will break. Mary Ann, thank you.

DR. GÓMEZ-LOBO: I just want to express a few perplexities. I'm not making any solid contribution here.

It's clear to me that Charles is right, that any discussion of regulations and, therefore, regulatory authority has to come after we have a clear idea of what we're going to regulate and according to which principles.

Now, the two great topics, enhancement and commodification of the body, with regard to enhancement, I must confess that I'm very much at a loss philosophically as to how to tackle the problem. That's why I kept my mouth shut yesterday when sports were being discussed because I really don't have a view of where the principles of the criteria are going to come from.

And that induces me to think that it might be wiser to start with the discussion of property in the body because in a way, I think there are certain traditional principles that give us some sense of orientation.

For instance, it strikes me as defensible that one should not, say, give patents over human beings, for instance, I mean, for reasons of human dignity, et cetera, et cetera.

Now, that should extend to different ages, different stages, et cetera. So I confess that I see some way of pursuing that topic. I see no way at this moment of pursuing the enhancement topic, and that would be a good reason for me and for others to sit down and try to think about it in terms of ultimately what the ends at stake are, as Paul was saying.

Thank you.

  - The President's Council on Bioethics -  
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