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Meeting Transcript
July 25, 2003

Ritz Carlton Hotel
1150 22nd Street, NW
Washington, D.C. 20037

COUNCIL MEMBERS PRESENT

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

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

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

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

Francis Fukuyama, Ph.D.
Johns Hopkins University

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

Alfonso Gómez-Lobo, Dr. phil.
Georgetown University

William B. Hurlbut, M.D.
Stanford University

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

 

INDEX

SESSION 5: BIOTECHNOLOGY & PUBLIC POLICY: DISCUSSION OF FINDINGS AND IDENTIFICATION OF POLICY OPTIONS

CHAIRMAN KASS:  Good morning.  Thank you all for your endurance yesterday. 

It was a very rich session and much to digest, and the conversation on the stem cell monitoring will continue in the September meeting.  We know already that Dr. Zerhouni will be with us to talk about the implementation of policy and give us an update on what's actually happening out of the NIH.  We're looking forward to that.

In this session this morning, "Biotechnology and Public Policy:  the Discussion of Findings and the Identification of Policy Options," we will be dealing with the two staff working papers that have been presented in your briefing book.

The first of these papers on findings contains findings that are distilled from the diagnostic document that was discussed at the June meeting, and the second, some policy options, a paper prepared in response to the council's request that lay out some general options both for general institutional reform, as well as for certain specific areas of concern, the latter derived really from and in relation to the specific findings.

And the goal for this session is threefold.  The first two, most important: 

First, to move toward agreement regarding what we have found in our diagnostic survey.  That will be roughly the first half of this session;

Second, to move toward clarifying some of the relevant policy options open for public discussion in the areas identified in the findings;

And, third, looking toward a subsequent meeting to begin to see if there are areas of common ground regarding some of those policy options that this Council might be prepared to recommend in the interim, while the longer conversation proceeds.

Our intention at the moment, subject to your approval and review, is to issue some kind of document some time in the fall, the major part of which will be diagnostic, and laying out certain of the possible policy options for the public to continue to consider.  And if there are places where we can agree on specific recommendations, we will do so even if it's limited simply to the matter of the need for more information, review, and monitoring in selected areas.

I should say you have at your place a printout from the Web edition of the morning Washington Post, where unsolicited we have editorial support for our activity, unheard of in the newspapers with respect to the workings of this Council.  Please read it at your leisure.

Before we start the discussion, I'd like to introduce one new member of the staff, Adam Schulman.

Adam, would you stand?

Adam is a tutor at St. John's College and is working as a consultant on the Beyond Therapy project for this summer, helping to get that into shape.

So the first part of the meeting on the findings paper.  I remind you that these findings are an attempt to distill the outcome of the diagnostic inquiry.  To make it perfectly clear as the document itself says, the listing of the findings is not intended to imply anything in particular, indeed, anything at all that would require public policy response.

And please note the place of ART in this document.  This has been stressed several times, and the purpose of this inquiry is not retrospective effort to regulate ART.  We've taken that up because it is the gateway technology  and the advent of new genetic screening possibilities and the like; build upon that, find their home in that context.

And therefore, thinking about monitoring reprogenetics begins really with thinking about the monitoring of this area of work.

I think we should probably go through the findings in toto and then one by one, as you would like.  This is not the place to do the line editing.  We want your comments on that when you go home, but the basic question is:  are these basically accurate findings?  And is there anything of importance that we have omitted?

And let me get some general comments, and then we can go slowly one by one.  And there are some people with special interests in these regulatory activities, and perhaps if I have no volunteers, I'll just call on you:  Frank, Rebecca, Jim, Mary Ann.

Rebecca, do you want to start?

PROF. DRESSER:  Okay.  I passed on most of these comments already, but let me say them for the group.

One overall reaction I had was that many of the problems, the findings described in the document could be applied to other areas of medicine, and so I guess I see two broad questions.  One is in what areas has this branch of medicine and innovative practice had less oversight than other areas of medicine and, you know, what problems does that create?

And then the second broad point would be:  are there reasons why this area of medicine should have greater oversight than other areas of medicine?  And if that's an argument, then what are the reasons why this particular area of medicine needs more federal oversight, that sort of issue?

So that was a basic question I had.  I do think the fact that many of these innovations have not received oversight for safety and efficacy in the same way that drugs and devices do is an example of where this has not received the same amount of regulation as other innovations.

Now, one of the reasons is that they often involve procedures, and procedures aren't regulated by the FDA.  So in some ways that's similar to surgery, but I guess I think that we should remember that there's a baseline of sort of standard practice of medicine and how the government looks at that practice and then remember that this is a component of that in terms of asking what kinds of oversight it ought to have.

CHAIRMAN KASS:  Thank you.

Frank, do you have?

PROF. FUKUYAMA:  Well, I think the summary is quite good, and it does point to a lot of the conclusions that came out of the last staff paper.

I guess there are a couple of things that we would need to talk about a little bit further about why we're interested in this, which in a way was addressed yesterday in the short exchange between Jane and John Gearhart, and in a way the Post editorial states it a little bit better than the staff paper, which is to say if the concern is simply with the safety of existing IVF procedures, I think you need to really make a case that the current levels of safety .- I mean, even if some of the statistics that were shown to us yesterday were true, you know, that IVF produces twice the level of birth defects, you know, of natural births, I mean, you don't know what the baseline is.  I mean, is that high or low, or is that something to really worry about?  Is that something that can simply be dealt with with informed consent?

And, you know, those are serious concerns, but it's not clear to me that that's sufficient to drive, you know, a major effort to, you know, talk about regulation in this area.

And I think that somehow it ought to be clear that the kinds of concerns that ought to be driving us are certain possibilities for reproductive medicine that are not germ-line, you know, that are not ten, 15, 50 years down the road, but, you know, possibilities that are actually fairly realistic that either can be done today or will be possible within the next few years.

I mean, for example, if you could take a stem cell and walk it back and produce an oocyte, you know, from a male, you know, a stem cell coming from a male so that a man could, in effect, you know, become a mother, I mean, do we say, "Okay.  Go ahead.  Do it, you know, if you want to"?  I mean, is this something that the society feels comfortable simply permitting to happen?

And that's the kind of possibility that I think does trouble people.  I mean, the Post editorial talks about a lot of those things that came up at this conference, and we need an evaluation, you know, also about what is going on in this area and how much of this really is, you know, near term and how realistic some of these possibilities are.

I think that that would probably help in setting the context for why we're interested in doing this.

As I mentioned yesterday during the last presentation, I actually think that there's still a lot more factual information that we need to collect on all of these topics.  For example, this question of the FDA's authority to regulate the practice of medicine, as I understand it, I mean, I'm not a lawyer, and so I just have to believe what I'm told by other lawyers, but I am told that actually if the FDA were sufficiently creative, its clear authority over medical products would give it a gateway into actually controlling quite a few procedures because there aren't any practices that don't involve, you know, products, medical products.

And you can interpret the authority of the agency, you know, in certain ways that would give you that authority, and again, they just have chosen for prudential, kind of political reasons not to exert it.

There's a lot of interesting things that have been going on.  For example, we were told that the FDA should have used the Administrative Procedures Act when it asserted its new authority over cloning, but instead used "The Diane Rehm Show."  That, in fact, may be quite a clever political strategy on their part knowing the problems of going through the APA.  You know, if you want to informally assert your authority, this may actually be a good way of doing it.

So there are a lot of mysteries really, I think, still of a factual nature about what powers the government currently has to deal with a lot of these sorts of issues, and I'll reemphasize something I said at the last meeting.  I really hope we don't get too driven by the timetable of, you know, the fact that our mandate only goes through November.  I really hope the mandate gets extended, and I hope that, you know, if we can get an early decision on whether the Council's work is going to continue for a few more months, that would be very helpful for this particular project because I do think that, you know, serious consideration of these issues really is going to require a lot more work on the part of the staff and Council members and so forth.

CHAIRMAN KASS:  Thank you.

Mary Ann.

PROF. GLENDON:  Yes.  I, too, think the findings are accurate and helpful, and I think it's worth remembering that just as many of these findings came as a surprise to all of us who have a certain expertise in the field, they involve matters that most members of the public are unaware of.

Most people, in spite of the fact that we live in a society that in some sense is committed against heavy governmental intrusion, most people think that somewhere there is somebody who is paying attention to their health and safety.  It comes as a surprise to find out how much is unrelated.

And, Rebecca, I'm sure that's true in other areas besides the one that we're studying, but this is the one that we're studying, and I'd just like to illustrate this point with an anecdote about a woman who came up to me.  She was sitting at one of our hearings, at our last meeting.  She came up to me afterward, and it was after I had asked a question of a provider of assisted reproductive technologies.  I said, "What do you say in your interview with the woman who comes to you?"

And she said that she and two of her friends had been in IVF programs, and that no one had ever spoken to them about the risks involved, the likelihood of success.  The interview consisted of, "you really want to have a child."

And I think the assumption, the background assumption, of a lot of these people is that somewhere somebody is looking out for me.  Somewhere there are governmental agencies that do keep an eye on things.

So I think just on this part, this staff working paper, the part about findings, it's very important just to do what our mandate tells us we're supposed to be doing, and that is raise the level of public awareness and deliberation.

CHAIRMAN KASS:  Jim Wilson, do you have something on this?

PROF. WILSON:  I did not have anything to say, but I will try to invent something in response to your request.

(Laughter.)

PROF. WILSON:  I feel very much as Frank and Mary Ann feel.  To me the most interesting part of this is the distinction we have to keep in mind between regulation and monitoring.  I do not have an ideological objection to regulation properly designed and properly applied, but I'd like to know the factual world to which it is applied before it is applied so that we can form some sense of the costs and benefits of various regulatory schemes.

And the lack of monitoring, the lack of carefully done longitudinal studies that follow children having gone through various procedures to me is quite disturbing.  I'm sure in other parts of medicine we may find that, although the various parts I know something about, largely having been a patient rather than a practitioner, is that there's a keen attention to what happens from longitudinal studies, and good doctors, which are not all doctors, take into account these findings in explaining the costs and benefits of different courses of action when you confront them, and that's highly desirable.

So that before I would want to design a regulatory structure, I would like to encourage very firmly the use of monitoring studies to follow people from ART, particularly those using ICSI and PGD and the newer technologies so that we can find out what happens to children.

And the argument for doing this firmly, as opposed to doing it in other fields of medicine, is that we are talking about the lives of babies, and we have a special obligation to figure out what the costs and benefits of these procedures are.

CHAIRMAN KASS:  Thank you.

Janet Rowley.

DR. ROWLEY:  Well, I have a number of comments about the paper.  I think that it certainly does reflect the areas in which we've been discussing quite effectively.  I think it's quite helpful to look at each one of these subsets and then try to figure out why is there no uniform or comprehensive data collection.

And as I pointed out yesterday, this is a very costly matter.  So the lack of data are direct results of the fact that there is no funding for this area of research, and I think that that actually has an influence on many of the other areas that are included within this staff document.

Looking at technologies and trying to improve them, following up on what Rebecca said, if you're going to, say, look at a series of techniques, trying to see which one is the best, this involves experimenting on embryos to see which one leads to, from whatever measures one can use, the best growth or you can't go and do these experiments in patients, which is what you would do in other scientific matters, because you can't just give five patients embryos treated this way and five that way and see which is best and then move forward.

So this is a very difficult area, but we give it no money at all.  So how can you express progress in some of these?

And the same, the concern about the fact that these techniques are not tried, say, on primates.  Primate research is exorbitantly expensive, and there's nobody to pay for it.  So we are the victims of decisions made years ago not to fund this research.

There's another area that was touched on yesterday, which I think is something that we should try to help at least bring to the attention of Congress, and that is the inequality of access to these technologies because poor black couples who might want to have a child, unless it's in a state where there is coverage for this, have to pay for this themselves, and this is thirty to fifty thousand dollars, and they don't have this kind of money.

So our health care system mitigates against wider use of this.  Our health care system also encourages the implantation of multiple embryos, which everyone agrees is a bad thing both for the embryos and for the mother, because of the way we finance health care.

So I think it's important that we not get into the mindset that it's the practitioners of ART who are doing all of these things which we find less than ideal and somehow they're doing things less ethically without looking at the causes of some of these.  And I think that that's extremely critical.

And I want to just close with pointing up Rebecca's first comment, that there's less oversight, and I'm not sure that that's so, of this area of medicine than others because who's looking at how you're doing appendectomies and who's looking at how you're treating diabetics?

There are general practices, but I'm not sure that we have complete databases on that, but then the question also is does it merit it, and some of what Frank said, it says that this is a unique area, and therefore, it merits some kind of consideration.  And one of the questions is what kind of consideration, oversight, to use Jim's words, monitoring does it require.

CHAIRMAN KASS:  Rebecca.

PROF. DRESSER:  Just to respond, when I said less oversight, I meant that innovations do not go through the FDA regulatory process.  Now, other procedures, in surgery, appendectomies, they don't either, but a new drug for diabetes has to go through the FDA, and it has to be tested, and all of the studies have to go through IRBs.  And so I do think there is differential treatment there.

Just a couple other points to throw out, the barriers to funding in this area put in place by the congressional ban on funding destructive embryo research would prohibit federal funding for some research that you might like to do to demonstrate safety in this area, but I don't think it would prohibit, say, a longitudinal study following children who were born from IVF.

Now, I don't know if there has been a policy decision at NIH not to fund that kind of study or if there's some other agency problem with that, but I don't think the statute itself would apply to all research that we would talk about here.

So just a couple of points.

DR. ROWLEY:  Well, it's my impression the CDC is empowered to do something, but I don't know exactly the scope of that and the time frame of that, and you can say they're an appropriate agency to undertake this because they're involved in other studies in epidemiology, though the subject matter of this is a little different than they've been involved in before, but it would certainly be helpful to know what the mandate of the CDC is or how they're proceeding and what questions they're asking.

Because we've pointed out there are a number of questions they may not be asking which we think would be very essential to gather necessary data.

CHAIRMAN KASS:  On that point, Janet, I think in the diagnostic document we did list what the federal statute requires the CDC to do in this area, and in the policy options, there is some identification of the kinds of things that might be added if we were so inclined, but we can talk about that when the specifics come up.

Frank, did you have something?

PROF. FUKUYAMA:  Yes, I have a slightly different point to make.  I've tried to peddle this idea to a couple of people like Gil yesterday.  So I'm interested to hear what his reaction will be, but I think there's another independent reason for wanting to have more monitoring and oversight over this whole area, which has to do with this whole question we've been talking about in the Council right from the beginning about what it means if you believe, like I do and a number of other council members, that an embryo has some intermediate moral status that's not the equivalent of an infant, but is not, you know, just a mass of cells.  How do you, you know, publicly recognize that or write that into law or grant that status?

And I think that, in fact, this kind of regulation would be a recognition of that moral status, and I'll just give you an example of that, which is the way that we treat dead bodies.

You know, if your Aunt Minnie dies, you can't just dump her body in a dumpster.  You can't render it.  You can't turn it into food.  You can't reprocess it.  You can burn it, you can bury it, you can do a lot of other things with it, but the government takes a very active role in, you know, setting rules and limits on the way that you can treat this object.

And it seems to me that the cadaver in a way is a good analogy, you know, for some other object that has an intermediate moral status that we do not regard as having political rights and so forth, but on the other hand, we don't regard simply as, you know, personal private property that is completely alienable and so forth.

And it seems to me that one of the things that society says if it sets up a system, for example, as existing in Great Britain where every embryo that is created the government keeps track of, is that, you know, in a way it's saying these things are important objects, and even though we can use them for scientific research and destroy them, we don't think that they are simply things that can be disposed of at the whim of, you  know, private individuals and that there's a public interest in keeping track of all of this.

So I think apart from all of the public policy issues about safety and, you know, whether we want to put limits on certain kinds of practices, simply the existence of a monitoring system itself it seem to me, in a way, goes to answering — because this question is constantly being posed within the Council as well.  Okay.  If you say they've got this intermediate moral status but you're willing to destroy them, you know, what does that mean, and I think this is one possible answer to that.

I mean, what it means is that we care really what happens to every one of these individual ones even if some of them are being used for scientific research.

CHAIRMAN KASS:  Let me ask that we bracket a response to Frank's comment only for this reason.  He's really dealing with the question of possible recommendations and policy options.  I would like to see if we have exhausted the comments on the findings themselves so that we can take those things up separately.

Rebecca, please.

PROF. DRESSER:  Just one more question that might be worth talking about.  This issue of access to ART, there is a finding that's indirectly critical of the fact that there aren't any laws or policies that provide access or take a position on that.  That's a hard question for me because we don't have, except for emergency care, we don't have laws that provide any kind of medical care to everyone.

So I think I would want to at least think about access to ART in the broader context, and in terms of setting priorities, going back to yesterday, I think there are some tough issues there, and I don't know if we want to wrestle with them, but I think definitely it is not for me an automatic recommendation or judgment that everyone should have access to these things.

CHAIRMAN KASS:  Mary Ann.

PROF. GLENDON:  This is kind of on the borderline between the two papers, but it seems to me that it does belong under findings.  One of the findings ought to be that these matters, many of them, are regulated in other countries of the sort that we generally compare ourselves with, other countries at comparable levels of social and economic development, that experts in those countries are somewhat surprised that we don't regulate.

CHAIRMAN KASS:  Anything further on the findings themselves?

Paul.

DR. McHUGH:  I have a completely trivial point to make, but perhaps it's useful to make this point.

You frequently use the word that I happen to like about the description of this, namely, reprogenetics, and it may be that we're at a point now where a term of this sort which grasps this discipline enough so as to talk about it rather than going just from element to element would be something that we'd like to recommend to people.  A word like that would be useful.

CHAIRMAN KASS:  No, thanks, Paul.

In fact, as some of you will remember, we floated that term late in the process of preparing the cloning report.  Its appearance in documents prior to its emergence in this room was troubling to some people and it was stricken.

But the Hastings Center's report on these regulatory activities, we heard from Lori Knowles about over a year ago, I think.  That document will appear, I think, in the next issue of the Report, and I think they've got reprogenetics front and center in the title.

And I know that Kathy Hudson's group is using it as well.  So maybe this is becoming not just a neologism that people worry about.  We don't want to be behind the times, but —

DR. McHUGH:  Let me just say that the advantage of it to me anyway is to not only grasp the things altogether, but also talk about how other elements that go on in the realm of reproduction and even in the realm of obstetrics might have ultimately come into play here.

I think I've mentioned to the Council before that I take care of a very sizable number of young women who have been fundamentally distressed by the triple test for Down's Syndrome that gets employed early on in pregnancy at a particular time.  I think you know about that.

What that does is the statistics over time say to the young woman that her chances of having a Down's child change from something like one in 700 to one in 250 and so, therefore, they should go on to an amniocentesis and various other things.

Now, whether they're interested in abortion or not, this test produces in them a most distressing state of mind.  Most of them as you see will have normal babies, and yet the genetic counselors are there saying, "You have the classic presentation for a Down's Syndrome child."  Even when they have an amniocentesis they still worry about it until that baby comes.  They then worry about it in every other baby they have, and they talk to people like me  about what this means.

Now, in France, for example, they insist on all pregnant women having this test, and it's slipped up on women in America, in my opinion, always with the idea, well, you wouldn't want to have a Down's baby as though you begin with that assumption and burden women tremendously in their pregnancy.

And that's an issue of reprogenetics that would ultimately be grasped if we had that concept in mind.

CHAIRMAN KASS:  Okay.  Let me make a couple of comments myself in response to the things that have been said, all of which I think are well taken and could be easily incorporated in the revised version of these findings.

I do think several people, Rebecca, have spoken to, given multiple reasons why this area (a) was the area that we set for ourselves; (b) it is an unusual area of medicine in that new babies are produced, and there are things here that are not strictly just therapeutic that have raised some kinds of concerns in the broader society.

And I think if not at least in the findings, certainly in the introduction of the diagnostic document where I think, by the way, some of that material already exists as to why we're taking this up, that could be strengthened.

I think the distinction between regulating and monitoring and the tremendous importance of getting a lot more factual information before anybody proposes anything restrictive, I think, is crucial.  We are at a very early stage of this process, to be sure, and I think that's the spirit of the enterprise altogether from the start.

And also I think the economic arguments can be beefed up in the presentation both to indicate Janet's concern, but also to suggest that it's not clear that one can somehow deal with this particular question of economics and access separate from the larger ones, at least to flag that question.

And finally, I do think, Janet that I would side with Rebecca to the extent to which some of the things that we would be interested in getting information about we could get information about and seek information even in the absence of federal funding, however desirable that might be.

I mean the longitudinal studies; it's costly.  But if people cared enough about this, I mean, there are ways to get it done.  But I think somewhere between those two points I think we can make that perfectly clear.

The government regulates, even regulates, not just monitors, certain things that it doesn't fund if there is sufficient interest in doing so, and certainly the information gathering in the thing there is that we need, I think, could be encouraged.

Are we prepared to move on?

By the way, if anybody has thoughts that occur to them when they get home on these things or details on the drafting, by all means we would like to see them.

Let's look at the second staff working paper, some policy options.  And here, as the introduction to the paper indicates, we have in a way two purposes, one, to simply lay out the alternatives, both with respect to the possibilities of institutional reform, things that it's quite clear we're not in the position to make any recommendations on in the absence of a lot more study, but at least we can identify some of the alternatives.

And then in some of the substantive areas of concern of the sort the findings have articulated, what are the various kinds of things that could be considered if the public were so interested to address those concerns?

Secondarily, but really more for the next time we talk about this, to see whether there are any specific actions or policies that the Council might wish to recommend as an interim measure while the discussion goes forward.

And here, once again, this is again really more for later.  Given the areas of division, this whole discussion could come a cropper over those matters which divide us.  Nevertheless, the exchange between, for example, Michael Sandel and Richard Doerflinger at the last meeting indicated that there are lots of areas of mutual concern and that the fact that there are some things that might have to be, at least for the time being, off the table.

It shouldn't preclude our trying to find those things on which people of common sense could agree and maybe even unanimously.

So I hope that the spirit that would govern these discussions is at least as much a search for common ground as it is to make sure that the various alternatives are stated with as much force and clarity as the public has a right to expect from a group of this sort.

So let's look at the second working paper and the various policy options.  To remind you, they've really been organized around the sort of larger institutional questions, the four institutional options of: a new agency; the augmentation of an existing one; specific congressional action; and using federal funding as a regulatory lever.

And then the substantive options having to do with the safety and well-being of children, the possible limits on what could be done  by way of implantation of human embryos for research, improved or equal access, the non-disease related uses of genetic screening and embryo selection, germ-line modification, and the various things having to do with commerce.  And then the research involving destructive research on early stage embryos.

Those are the seven areas, and the series of policy options are out there.  And let me just open the floor for discussion without editorial comment.

Jim Wilson.

PROF. WILSON:  I'm not persuaded that we're at the stage in our knowledge where we are prepared to describe any institutional option.  We have several available.  Each has some benefits; each has some cost.  The chief cost in all is that they're concerned with other things, and in my experience adding a new and very different task to an existing federal agency almost insures that that new task will receive relatively low priority unless it's supported by a large body of information conveying the fact that this is a very important matter where a regulatory arrangement of some sort may affect human lives in a desirable direction.

So that though I'm not opposed to designing new institutional options, and we may well come to that, I would prefer focusing as much of our discussion on the substantive issues as we can.

CHAIRMAN KASS:  That said, Jim, could I invite you to comment on not so much about what we're going to recommend, but the adequacy of the articulation of the various issues and the alternatives?

I mean, is this a good beginning in the laying out of those options?  And if they can be improved, have you suggestions?

PROF. WILSON:  No, it's a very good beginning.

CHAIRMAN KASS:  A man of few words.

(Laughter.)

CHAIRMAN KASS:  Good ones.

Comments?  Frank.

PROF. FUKUYAMA:  Yeah, I think the one major option that is really not represented here is a much higher level of self-regulation on the part of the affected industries, the ART industry and the part of the scientific community that is — in fact, Gerry Schatten, I believe, when he testified, said that we need an Asilomar-like process within our industry.  I mean, they do self-regulate already, but presumably this option would involve a new effort given the new technologies that are coming down the line to really impose a tighter set of rules and different enforcement procedures and so forth.

And, again, I mean, to evaluate this I think it would actually be helpful to have an economist, you know, look at this because when you look at the viability of something like self-regulation within a particular industrial sector, it's all a question of understanding the incentives, and it involves a lot of game theory and things that can be analyzed fairly readily if you have the right analytical tools.

But I think it is an important option and certainly the option that the industry will favor above any of the ones that are laid out here.

CHAIRMAN KASS:  Janet.

DR. ROWLEY:  I'd like to make two comments.  One is the follow-on with Frank's, and as I'm sure you're all aware, the medical profession does have a number of societies and colleges that are each one associated with a particular medical discipline, and these are all put together under the rubric of the American Association for Medical Colleges.

And so looking to see which ones people think function most adequately and then giving their both advice but also their experience on this matter of self-regulation might be helpful to us, and so we could certainly consider having someone from that group come and talk.

I do want to speak in favor of Jim Wilson's view that — and I realize you agree yourself— that gathering more data to see what the situation is before we try to figure out how it ought to be regulated would be a very wise approach.

And the last comment I wanted to make is that as we've heard very early on in our discussions, there were a number of panels that have been advisors to NIH on some of these matters.  Each panel recommended that there be an oversight body established, and they were actually fairly explicit about what kind of oversight body should be established.

That's one of the reasons that I asked Lori Andrews a question yesterday, because the RAC is such a body and would a comparable body with some oversight responsibility in this area be appropriate, and clearly her answer was that it was okay to have such a body, but it shouldn't be at NIH.

CHAIRMAN KASS:  Thank you.

Paul McHugh.

DR. McHUGH:  I want to back up both Jim and Janet on this because I also believe that some kind of institutional organization has to be formed to oversee this matter, but it's perfectly true that unless the American public realizes that there are lots of things at stake here, there will not be the energy for this.

There is a little sense that comes both from the RAC experience and from the British experience that unless the scientific community begins to feel that the villagers have their torches out and are going to come and burn down the laboratory that nothing will happen.

I'm very encouraged by what we see in the Washington Post today, that the people are beginning to, like the British people when they discovered that there was genetic changing in their food, then they terrified the scientists to make sure that they did have regulations put in place.

I want us, as a body, and perhaps others as well to remind people that there are awful things that could be happening out there if we don't have oversight, and that the oversight should be opened and developed, and the RAC is a perfect example not only in its genesis, but then actually in its success in managing things, monitoring things, and ultimately controlling things.

CHAIRMAN KASS:  Two things before the scientists come to correct you on this.  First of all, I don't think it's the purpose of this body to get the people out with their torches.

(Laughter.)

CHAIRMAN KASS:  Second of all, and this ties up with Frank's point, the RAC is the legacy of a warning developed by the scientific community itself, and while we have discussed this at some length and my view is that the RAC and Asilomar are interesting but only partially relevant models because they have, in fact, by design confined their attention primarily to the questions of safety where we have additional interests here, nevertheless it seems to me we cannot think about going forward in this area without the active participation and, in fact, the leadership of the scientific community and the biotech industry.  Otherwise what one is going to have is fighting.

One has to, I think, mobilize enough interest on the part of the general public so that people care enough about this to perhaps make it clear that these things might be urgent, if they are urgent, but I don't think that the spirit is the spirit of combat and contention.

DR. McHUGH:  Well, I agree with you, of course, at one level.  I just mean at some point people have to be feeling that this is an inspired enterprise, and it relates to the future of people in America and that it's an important thing.

I agree that, of course, the RAC was something out of the scientific community, but I don't think anyone can deny that the issues of the people of Cambridge, Massachusetts, and their concern for what could have happened with recombinant DNA played a role in exercising the scientific community enough to do what they did.

CHAIRMAN KASS:  Point taken.

Elizabeth.

PROF. BLACKBURN:  A fairly general comment which arises from what you said in your introduction and from the document in our discussion.  What I'm sensing is that — well, my feeling is that this is important enough that we should be thinking about the sorts of principles of governance, in general, and you know, if we think about governance and setting into place how checks and balances are assured, then I think that, you know, the fear that we're sensing is that some group will grab control of this process, but if the governance of it is set up in such a way — and I'm obviously speaking way out of my expertise — but if the governance is set up in a way that people feel, yes, institutionally it does have the checks and balances that do allow the different views to be heard and all the information to be taken into account, then you know, I think we have the makings of a process that will be better and addresses what you're saying, that there may be areas of consensus that can be reached, and if they can't be reached, that at least there's a confidence that there's a process by which the views get heard, and that's built into whatever governance, you know, ends up dealing with these areas.

CHAIRMAN KASS:  That reminds me — Mary Ann, please.

PROF. GLENDON:  Well, I just wanted to say that one of the great merits of the staff work on this paper has been to put before us the diversity of the options that are available under regulation.  I think we have to do whatever we can to dispel the idea that regulation always take the form of banning or not banning, funding or not funding.  I think this is just excellent work in showing that regulation can encompass, as Frank said, monitoring, gathering information, a whole spectrum.

And the techniques, the art of the matter of regulation, the techniques have to be properly matched with the problems, and they will be quite diverse.

Having said that, it seems to me that some of the matters raised here are ripe for consideration with regulations of fairly familiar types.  I would say regulation under the general heading of consumer protection is well known to all of us, and consumer protection sometimes just takes the form of providing information.

So, for example, I mean, a couple of areas that seem to me ripe for moving ahead, areas where we have sufficient information to move ahead, would be these informed consent suggestions on page 8.  After all, with IVF we have a multi-billion dollar industry that is, we have now discovered, virtually unregulated, and ordinary application of consumer protection, laws, and principles would suggest at least the provision of more information to people who are increasingly clients of this industry.

And just another issue that is unrelated to that, but I thought we shouldn't lose track of Frank's interesting analogy to the way our society treats that human cadaver, and I just wanted to add as some support for what Frank said that there are many legal cases in the states which specifically say that no one can have a property right in a cadaver.  The next of kin have certain rights regarding manner and place of burial, but people who have tried to make the claim that they own the cadaver have, as far as I know — I don't know of a single case that has recognized a property right.

CHAIRMAN KASS:  Bill May and then Dan Foster.

DR. MAY:  Sometimes plea for more information can give the impression of a covert argument for delay: "We don't want to really do anything."

But Jim has offered the important plea that we need more information so as to know (a) whether regulation is warranted and (b) what kind of regulations make sense.  This gives a kind of important instrumental value to monitoring.

Monitoring also offers a kind of warning that the society cares, that the society is watching, and thus it begins to serve a kind of cautionary regulatory function even if you don't put in the train actual regulations, it can under certain circumstances.

Yes, reporting and so forth can become pro forma, but on the other hand, it begins to say something, and in a way maybe this paper needs to talk more about the deeper moral justifications for monitoring.  As Jim put it very simply, hey, we're talking about babies.  You really want longitudinal studies.  It's very important.

We're talking about human beings or, Frank's point, we're talking about preimplanted embryos which have an intermediate status, and it deserves being watched.

Monitoring, to steal from old Arthur Miller, means attention must be paid.  Not to monitor in areas like this means literally carelessness.  The society does not care.  As long as it's done in the marketplace, anything goes, and the society at large does not have to firm itself up to pay attention.

So this kind of monitoring grows out of care in some sense that attention must be paid, and I think more needs to be developed along this line in this document.  Otherwise, reading through this document lots of options and so forth, and we need more information.

That doesn't quite answer what the Washington Post was hoping for in this statement.

CHAIRMAN KASS:  Bill, thank you.

Can I make a response?  Because I think absolutely well taken.

Mary Ann, I think, at the last meeting asked that the document have, in the spirit of toward a richer bioethics, that one not simply play engineer and lay out the alternatives, but that one discuss in some kind of thematic way exactly the sort of thing you're dealing with and the sort of thing Elizabeth is asking for, namely, some kind of reflection about the meaning of monitoring and regulation, specially in a country such as ours.

The place for it, I think, is probably not at the statement of the findings or only in the place of policy options, but even could go very early on in the document as a whole.   And it is, I think, our intent to have such a thing, and it's my hope that we can tap several members of the council to help us with the drafting of that.  There are people around the table who have much more experience both in terms of political philosophy, the area of regulation, and even this very beautiful formulation of what it means to monitor and to attend and to care.

I think it would be unusual in a document on regulation and in the spirit of the kind of work that we do to have such a thing in there.

Do you want to pick up on this point?

PROF. SANDEL:  Yeah, on this.  Is that all right?

CHAIRMAN KASS:  Would you?  Thank you.

PROF. SANDEL:  I heard two things in what Bill said, but I may not have heard correctly.  One would be satisfied by language that reflected on the meaning of monitoring.

The other I thought was a suggestion that a call for monitoring would be a reasonable aim that might not be subject to the controversy that you said we should avoid and that might not be subject to the long time it would take to develop and to consider actual institutional arrangements and so on.

Did I hear correctly?

DR. MAY:  Yes, yeah, yeah.

PROF. SANDEL:  And if so, could you, Leon, or might others address the second part of the suggestion that this might be a reasonable proximate aim given our limited time horizon and so on?

CHAIRMAN KASS:  Well, the question of the limited time horizon is open because Frank has raised it.  I think we have a short-term time horizon, and I regard this as a preliminary inquiry, diagnosis.  But we wouldn't be undertaking this enterprise if this group as a whole didn't think that there was some reason to care.

Some people care to the point of anxiety.  Some people care simply in the sense of to pay attention and to think this is important, and my guess is — I'm guessing — that if one formulated the questions properly, there might be unanimity around the table that we would like to have more attention paid officially to Items 1, 2, 3, 4 and 5.

We would like to know about the well-being of children.  We would like to know about the informed consent procedure.  We would like an accurate accounting of the question of the costs, a variety of things of that sort.  The reporting on the uses of PGD that don't have to do with disease if there are any, and the like.

My guess is we might be able to find some kind of an agreement in a call for the paying attention, and my hope is that if there are such things, that they are the expression of an ongoing concern at this particular time that might even be given some effect even as the longer term question of what kind of larger institutional reform might be desirable be a subject of a much more extensive, thorough and careful inquiry.

So exactly.

PROF. SANDEL:  Just a question of clarification.  Would it be going beyond where you think we should go now for reasons of controversial reasons of time to have the staff develop as part of the completion of this regulation, interim regulatory report to suggest ways and to produce a call to monitor the creation and disposition of embryos in IVF clinics in the United States?

CHAIRMAN KASS:  Yeah.  Without getting into the details of the substance, the motion is first the diagnostic document, then the findings, then the laying out of the possible policy options, and then next time we visit this topic, it's my hope that the staff, having consulted with all of you, would be able to put forth a series of possible propositions, of which that would be one, to see whether — looking for the common ground.

Now, is it your suggestion, Michael, that we take that up now and see whether there's agreement on it?

PROF. SANDEL:  Well, I wasn't so much addressing that, though that might be a worthwhile thing to discuss, but really whether you saw within — you've emphasized you want to delimit the regulatory project for reasons of time and of controversy, which I understand and I think all of us understand.  And so I was just asking whether a relatively modest proposal of this kind would be too ambitious given the time and controversy constraints —

CHAIRMAN KASS:  Not at all.

PROF. SANDEL:  — that you have.

CHAIRMAN KASS:  No, not at all.  In fact, in the last paragraph of the italics part of the beginning of this paper there may be matters where nearly everyone is in agreement about the need for more information, for improved oversight, or for specific reforms and action.  Using this document as the point of departure, we would like to discover any such areas of common concern and agreement and whether there might be certain actions the Council would recommend.

And that, I think, would be the agenda item for the next time we visit this topic, probably in September.  So we have one session where the staff has, after consultation, tried to put together a list of such common things to see whether they are, in fact, common.

Dan Foster is patient; has to put up with the loquacious characters.

DR. FOSTER:  One of the things that occurs to me in looking at the overall documents about proposals is this.  One large component of what we're talking about is really not novel, and that is that medicine always is looking at outcomes.  I mean, so we reexamine the use of estrogens and progestins in women long after it has been accepted that it would protect against heart disease and so forth, and we find that there are other questions.  This is a monitoring system, and people have looked to see if what was thought to be truth is true.

And so it doesn't take very much to say what needs to be done in terms of in vitro fertilization and so forth.  There's quite a large experience of it now, and it would be fairly easy to see what we need to find out what the long-term consequences are.  The structure of this does not really require much intellectual thought.

And as a consequence that may be something that's different from the regulatory policies for things of the future, that is, what we're going to do about gene therapy, germ-line therapy.  All those things are new, and as a consequence might require something more distinct and novel than the first part of this.

And it would seem to me that conceptually we ought to make that differentiation, and the first non-novel thing that we ought to follow doesn't require — you might say where you're going to house this and so forth, but it doesn't require anything other than common sense to say that we need to find out what's happening.  Is it true that these children will have more complications, more diseases, and so forth?

It's going to take time to do that. So I would sort of in my own mind want to separate out the immediate things that are not novel, that we have many multi-center trials and other ways to figure out how to do, and that could include what Michael says.  We're going to account for all of the embryos right now.

I think where the big problem is going to come is for the future, those new things that are coming along and where that ought to be housed, and so the only point I'm trying to make is that I think that for me it might be a dual recommendation here, one that really is immediately applicable, and then the other is going to require considerably more thought, whether that's going to be a RAC-like thing or whether it's going to be at the NIH or what it's going to be.

So I think we could move ahead very quickly on some of the things that we need because that's what people are already doing and have done and will continue to do.

I mean, we do lumpectomies or mastectomies.  You know, we just monitor and find that out.

CHAIRMAN KASS:  That's a very useful distinction.  Thank you.

Gil was on the list and then Rebecca.  Gil Meilaender.

PROF. MEILAENDER:  Two things.  One, I mean, sometimes in a group you struggle forever to arrive at something that, in fact, if you just sort of voted on it at the start everybody would have agreed on, and I do think to some degree with part of what we're talking about that's true.

With respect to the idea that more information in the sense of good studies is needed, conceivably even in terms of Mary Ann's consumer protection language.  That doesn't answer Janet's who pays question, you know, exactly where this should happen, but I don't sense a lot of disagreement on that point.

The second point I wanted to make just as a larger issue having to do with regulation understood more expansively than that limited area on which it seems to me we probably actually have a good bit of agreement, Mary Ann had described it as needing to know that somebody is looking out for my interests.

But I think there's a tricky matter here.  There's a good bit of evidence  by now to suggest with respect to the recombinant DNA issue that, in fact, as opposed to arriving at something intended to look out for the people's interests, it was a strategy designed precisely to remove the question from the realm of the people and their elected representatives so that looking out for my interests can sometimes come to mean deciding what my interests are, and that's a different matter entirely.

So I want to make a fairly sharp distinction between some of those fairly basic questions on which I think we have a good bit of agreement, even if some puzzlement, about kind of who would fund such research and so forth, and larger questions about regulation on which I think not only we're not sure, in Dan's terms, kind of exactly what the questions would be or who should look at the, but even what the best way to deal with them that really qualifies as looking out for the interests of all of us.

CHAIRMAN KASS:  Rebecca.

PROF. DRESSER:  I think that maybe this depends on whether our project gets extended, but if we are going to use the RAC as a model in our conclusions/recommendations, I think that perhaps we should get more of a case study of the RAC because it's an interesting entity.

It, strictly speaking, does not have the power to turn down studies.  It has the power to require a public discussion, and even that power is only applied to studies that come from institutions that receive federal funding for rDNA research.

But most of the privately funded studies are also submitted because of this informal acceptance by industry that this is a good thing for them to do.  So it's a mixed voluntary/mandatory system.

The FDA is then the one that backs it up and is trying to work more with the RAC, and they would have the power to turn things down, and they have exercised jurisdiction over genetic modification research.

So it's a little more complicated, I think, and also we should acknowledge that in the Gelsinger case the RAC made a recommendation about that study to make it safer, at least what they thought was safer, and it fell through the cracks.  The recommendation was not followed, and that's believed to be one reason why Jesse Gelsinger died.

So it's not a perfect system, and if we're going to rely on it as a model, I think we should get some more details on it.

The second comment is I don't know if this would be acceptable to people, but a possible supplement to a recommendation for increased monitoring would be and distribution of the information that's discovered perhaps on a Website.  The government, NIH, now has lots of stuff on the Website that's intended to educate patients, prospective research subjects.

So providing a, quote, unbiased account of the information that we have now, as well as the information that's discovered with more monitoring would be another action that I think the federal government could take that would possibly be less controversial.

You might get into debates about what that information should say, but if there were a place where people could go, people who were considering these various methods could go to get, you know, down to earth information on what's out there, what we know about these procedures, that would be helpful, I think.

And then finally, there is another dimension to this outcomes research that might be more controversial.  I think just studying the health of the children, the physical health of the children is probably not controversial, but to the extent that we might want to recommend or discuss outcomes looking at the well-being of these children, the psychological well-being, the attitudes the parents have toward them, those kinds of questions, I think our last standard and outcome studies, I mean, they are looked at that to some extent, but that might be a difficult thing to study and a controversial thing to study.

CHAIRMAN KASS:  Jim Wilson.

PROF. WILSON:  I don't want to disagree with Mary Ann's suggestion that an improved informed consent agreement might be preferable, but I do want to issue a cautionary remark.  I go to the doctor a lot, and even for routine exams, you're presented with a clipboard that has ten sheets of paper on it, and you're told before the doctor can see you, you have to read and sign all of these.

Well, having done this often enough, I don't read any of them.  I sign them.  I'm thinking of having a rubber stamp invented so I can avoid signature bursitis.

And as I look around the room at other patients, a few stare at them, but most simply sign them.  The informed consent procedure is drowning in its own commonness.

Now, there may be a way by designing a kind of document that says, "Warning.  If you follow this procedure the chances of the following unfortunate outcomes rise by X percent," or above a baseline.  "On the other hand, the benefits will rise by Y percent."

Now, my physicians whom I deal with about matters of some importance go to great lengths to explain to me orally in their office what's going on, and I depend on their advice crucially, and I appreciate their professional skill in supplying it.

But the informed consent agreement supplies nothing.  So that before we amiably agree to an improved informed consent procedure, we ought to take a hard look at it to see if it does any good at all.

CHAIRMAN KASS:  Mary Ann.

PROF. GLENDON:  Yeah, I think all of us who consult physicians have had exactly this experience, and I often think as I add my signature I'm a lawyer and I'm not reading the document.  This is what you told your students you must never do.

But I think there is an important distinction between these informed consent forms that we have before medical procedures that we know we've got to have anyway, whatever the risks are, and what happens at an in vitro fertilization clinic where the person who goes there is more like a buyer than like a patient.

It's a buyer of a service, and consumers are very interested, Jim, in knowing — especially consumers of a very high priced service — they are very interested in knowing what is it going to cost, what are the chances of success, what are the risks and the down side, and that's why I put it under the consumer protection rubric rather than under patient's informed consent.

CHAIRMAN KASS:  Frank.  Frank and then Janet.

PROF. FUKUYAMA:  Well, I have two separate points.  Rebecca is absolutely right.  We should not take the RAC currently as a good example or necessarily good example of self-regulation. 

There was actually a 25th anniversary conference or the 25th anniversary of the founding of the RAC where people, you know, evaluated where they were now, and a lot of conclusions were that, in fact, the industry had changed sufficiently such that self-regulation did not work as well now as it did when the organization was founded.

That stands to reason.  This kind of self-regulation works best in small, homogeneous industries that are based in one country where all of the players know each other.  When they get heterogeneous, when there are a lot of, you know, different interests, when you get a lot of international players, this kind of thing tends to break down, and the industry has changed a lot.

I mean, in '75 when Asilomar was first held, all of the funding was federally funded, you know.  There were scientists that all knew each other, and they could police each other pretty well, but the character of that industry has changed.  There are a lot of private players.

I spent some time at Johns Hopkins which has a Center for Civilian Biodefense Studies that's headed by Tara O'Toole, previously by D.A. Henderson, and it was interesting talking to them about the RAC because they're worried about, you know, rogue labs doing bioweapons research, and I asked some of the young microbiologists there, you know, "When you do your studies do you regularly go to the RAC?"

And they all laughed and said, "No, you know, too much paperwork, I mean, and we're not going to do it."

Well, what about, you know, their ability to even know what's going on in, you know, recombinant DNA that may be of concern, you know, for national security purposes?

And they said the RAC, you know, that's not the agency that will do this.

Can I make a completely different point?

CHAIRMAN KASS:  Please.

PROF. FUKUYAMA:  This is a procedural issue about how, assuming that we've got more time to study this beyond the current, just the next meeting.   I think it's really important to get the views of all of the major players. 

I mean, we've got, you know, in the audience today representatives of the ART industry, and I think it's really important to get, you know, a good sense of buy-in and have people talk directly to the Council about their views on these issues.

And I think I just want to reemphasize.  I forget who at this point made this point about how this will not come about unless the industries and the scientific community directly affected by this, you know, believe that this is somehow necessary.

Now, Paul  mentioned, you know, the concern in Europe over GM foods.  It's a kind of odd. I wouldn't raise that as a great precedent because I think that a lot of that, the peasants, you know, with the torches are actually pretty irrational on that issue, and you certainly don't want to encourage that.

But there's an important lesson for the ag-biotech industry that comes out of that European experience, which is that Monsanto in particular had the option of going for a limited form of labeling when they confronted this issue in the early 1990s, and they took the attitude, well, you know, it's going to cost us a lot of money, and we know that the science doesn't support the lack of safety of GM foods, and so they just plowed ahead.

Europeans then clamped all of these regulations, including labeling requirements, and they have been closed out of  European markets as a result.  I think if you talk to their executives privately about whether they regret that decision, a lot of them will say, "Yes.  In fact, even though we think it's irrational, it would have been better for us if we had accepted, you know, a modest degree of regulation that we could live with."

And I think none of this is going to work unless, you know, the affected communities come to feel that this is in their self-interest to do so both procedurally, if you ever design an actual institution, but I think procedurally within the Council it's extremely important to develop this sense of buy-in from people that will have to live with this stuff.

CHAIRMAN KASS:  Thank you.

Janet.

DR. ROWLEY:  Well, I was just following on the comments about informed consent, and of course, this is driven by the government requiring that one has more and more detail for individuals to sign so that hospitals are continually making their informed consent much more comprehensive and, therefore, ten pages long in order to meet the government requirements.  So that is an issue.

CHAIRMAN KASS:  We are close to the end of the time allotted for this session.  Let me see if I summarize the sense of what's here.

There have been specific suggestions both about the findings and about the policy options papers for enlarging them, perhaps shifting the emphasis, but the general sense is that the staff has done a pretty good job in both summarizing and providing the array of things to be thought about, and that the next step really would be to go through this perhaps with some intermediate consultation from all of you and see what kinds of concrete things we might consider by way of recommendations at this particular stage, as well as the things we might encourage for further reflection and study in the next phase of such an inquiry.

Specific comments and criticisms on these documents by E-mail, please, and we will have something for you when we next convene on this topic, which I think will probably be at the September meeting.

PROF. WILSON:  Could we also add this notion of a brief case study of RAC, which I think if somebody could do that it would be extremely helpful to me since I am an outsider?

CHAIRMAN KASS:  A brief case study.  I think it's a major job.  Am I wrong, Rebecca or Frank?

I mean to do this properly would be —

PROF. FUKUYAMA:  There's a literature, though.  There's an existing literature on this.  So I think you could fairly easily review what has been written already.

PROF. DRESSER:  That would be a shortcut.  Just give some articles at this point and then maybe later decide.

DR. ROWLEY:  Of course, another thing one could consider, Ted Friedmann is the Chairman of the RAC.  He has already come and spoken to us on gene therapy, but it might be possible either to have him come or to ask him.

Now, some of you may say, "Well, he's got a vested interest.  So it's not going to be the same," but you know, he is a pretty thoughtful individual.  If he could write a paper, such as Catherine Verfaillie or Jim Thomson did, for our next session, that might be a helpful perspective in addition to the literature that you're citing.

CHAIRMAN KASS:  Why don't we take under advisement some way to get some kind of material, whether from Ted or from the existing literature at least as background if not at the meeting so that when we next time meet we have a further sense of how that has been working.

For a change, we finished a session on time.  Am I right?  Yeah.  In 15 minutes we'll reconvene at 10:15 for the next session.

(Whereupon, the foregoing matter went off the record at 10:01 a.m. and went back on the record at 10:22 a.m.)


SESSION 6: BEYOND THERAPY: A PROGRESS REPORT

CHAIRMAN KASS:  All right.  The sixth session visits the other large project that the Council has been carrying forward, the working title for which is still "Beyond Therapy:  A Progress Report."

This project, just to remind you, is an inquiry into the available uses of biotechnology that go beyond the healing of known disease to achieve a variety of possible other human goals and satisfy widespread human desires both worthy and unworthy.

And despite the difficulty of working on this topic, there are many disparate technologies.  The concerns are inchoate and very complicated.

We have agreed to pursue this topic for public discussion for a number of reasons.  First, it gives us an opportunity to talk about the ends or the goals for which these technologies are to be used and not simply the safety, efficacy, or the morality of the means.

Second, it bears upon the question of the nature and meaning of human freedom and of human flourishing.  It addresses the alleged promise touted by some of some super humanization and the alleged threat deplored by others of dehumanization.

It also compels some attention to how these technologies force us to ask the question of what it means to be a human being and to be active as a human being.  And although some of these things are in the future, the current trends make it perfectly clear that the push beyond therapy is already upon us in performance enhancing drugs, in mood altering agents, and the like.

Also, some of these issues are of special interest in a free society where the presumption in favor of the private uses of many of these things to improve our lives might have consequences in the aggregate that feed back upon all of us in which we might actually regret the consequences of allowing everybody to have the benefits of their own free choice.  Choosing sex of children would be just one possible instance of that.

In educating ourselves, we had presentations from experts on drugs that affect behavior, mood, and memory.  We had presentations on drugs and genetic modifications that would affect athletic performance, on choosing sex of children, research on aging and the life span, genetic alterations of muscle, and the possible enhancement uses of PGD and directed genetic change.  And we had staff  working papers on all of these things which were discussed.

In working toward presenting our reflections in this area, we decided to organize the presentation not around the technologies themselves, but rather around the desires and the goals that either drive our interests in these techniques, a desire for longer life, or that will enlist the available powers that they make possible, desires for longer life, finer looks, stronger bodies, sharper minds, better performance, happier souls.

And this enables us also to think about how these new biotechnological powers fit with previous and present human pursuits and aspirations, not necessarily mediated by technology.  I think that's one of the interesting benefits of regrouping them in this way.

You've been reading some of the materials that have been organized along these lines in connection with the desire for better children where, surprisingly, we've tried to put together in one analysis things that might improve the native capacities of our children through genetic alteration and improving their behavior through behavior modifying drugs and materials that discussed enhancement of performance, whether enhanced, say, by steroids or by genetic alteration of muscle and the like, and there will be materials to come.

I think everybody should remember that the spirit and purpose of this enterprise is educational and not primarily political or practical.  There are urgent things that we've been called upon to address, and we're going to try to show our ability to address those, but here we want to take a step back and look at the larger field to try to sort out fact from fiction, real technological possibilities from merely imaginary ones, to clarify in an educational way the ethical issues both for individuals and the larger society.

We want your careful comments on the materials that you are now reading and will be soon receiving, but I think for today we would like to have some general comments on the organization along these lines and also on some of these substantive issues that we have flagged for your attention along these lines.

And I don't want to give, you know, a fully account, but enough to at least elicit the kind of general reflections and responses I think that would be helpful.  Specific comments on drafts as they emerge we will certainly welcome.

Of course, in all cases one is interested in the benefits and the possible benefits of any of these new technologies.  Of course, one is interested with questions of safety.

But when one thinks about the application of genetic technologies to begin to possibly select offspring for traits, something that was discussed for us by Francis Collins, there are questions that have to do with parental responsibilities, questions about genetic discrimination and quality, questions about parental responsibility and the possibilities of changing attitudes towards children.

In the choosing of sex of children, there are questions about the limitations of liberty, of reproductive choice.  There are questions about sex discrimination, and again the questions of parental control over the quality of offspring.

And when you think about the seeking of better children with the behavior-modifying drugs, there are questions of social control and conformity, and the questions of the medicalization of moral education, and finally, a kind of larger question about the meaning of childhood altogether when it is all simply bent on enhancement of performance to meet certain kinds of external standards.

In the discussion of the pursuit of superior performance with the use of athletics as a model, not because we think that's the only activity, but that's somehow visible to us, it's important for us to try to distinguish between how biotechnology would differ from, let's say just better weight training or better diet and the like.

One has to think about questions of fairness and equality in those activities where superior performance is competitive, and one has to think about questions of the overt coercion of the sort one saw with the East German swimmers and the more subtle coercion of the sort that I believe it was — was it somebody who was counseling one of the San Diego Charter linemen?  Was it you Paul? — about unilateral disarmament in a world in which all of the linebackers are on steroids and the poor running back is at their mercy.

But also there are questions, perhaps the most philosophical question, in that kind of discussion about the dignity of human activity, for lack of a better word, about the relation of the doer and the deed and the difference between acts of humans and human acts, that is, acts that somehow reflect and flow from our humanity, things in which superior performance is somehow related to the things that we do as opposed to the things which we are merely passive and don't result from our own exercise.

And in all cases, the question, in a way the most interesting question and the hardest to get a hold of is never mind what this might mean for individuals.  What would it mean to live in a society in which this kind of practice were generalized, in which the performances were all enhanced of that sort or you couldn't somehow tell who was or who was not in this way enhanced or in the case of children, what would it really mean if one begins now to have — in a society in which somebody was saying earlier in the meeting in which there are high pressures to buy one's way into the nursery school at the 92nd Street Y, where some of those advantages could be had also with pharmacological agents that would improve the behavior, attentiveness, and ability to learn.

So those larger questions about the social character are there for discussion.  I think the real question is about the organization and whether these issues that have been identified are germane and an opportunity actually even to discuss some of those issues here.

I should say, by the way, on a subject of concern to several of us, well, we have, I think, in the spirit to, on the one hand, try to dispel certain kinds of worries that seem to be unnecessary.  At the same time, without exactly prophesying the future, if there are identified areas of concern, I think it's incumbent upon us to at least put them out there for consideration so that they can be studied and investigate, at least aware of the kinds of things that are at stake.

So that sometimes the tone will strike some of you as unduly worried and in other cases insufficiently so.  It's difficult in this area to strike the right balance, and we take your guidance on that as well.

I hope that's enough to produce some responses on the basis of the things that you have been reading and are now able to anticipate as well.

Gil Meilaender.

PROF. MEILAENDER:  Well, there's a whole range of things I'd be interested to talk about, but let me just make two comments right now.  One is really no more than a comment on organization.

The direction the staff is moving now and inviting our response to is one that is a little different, in fact, from what we had been talking about, at least in the sense that we had kind of latched onto the most obvious organization principle, namely, certain case studies as kind of just examples to be taken up in their own right.

And the attempt now is to try to think of these in ways that cut across the normal lines, organized under various human desires.  And my comment is simply to say I think that's quite good. 

There are moments when it does seem counterintuitive.  I mean the combinations are at first sight strange, but what it suggests is that it's not so much in many of these cases that we're trying to take a case and sort of, as it were, vote up or down on it, good or bad, but that rather we're simply trying to say here's what a very different future may look like, and to see these different things organized in these ways seems to me to be a kind of promising way to do it.  So I rather like that.  That's my comment on organization.

Then a second is — I guess it's still a comment, but it's not quite as positive — is related to that insofar as this is an attempt to organize things around goods or goals or aspirations and not means questions.

That's fine.  As I say, I like the organization, but I'd want us to be careful how we formulate that connection.  So that, for instance, if we talk about parents selecting out certain children or selecting in certain children, I'd want us to try to avoid a certain tendency that I think easily crops up, given that we're focusing not on means so much, but on goals and aspirations, and that is to suggest that the one is weightier than the other because it's concerned with goals.

I mean, I would say that though it's good, we should have a lot of concern about selecting in children for various reasons, what's really central to our concern in this project, a certain kind of continuity with parental responsibility, you know, that you're trying to help your child and improve the child in various ways.  It does stand in a certain continuity with it even if problematic and dangerous in certain respects.

Selecting out I have a much harder time understanding as standing in any kind of continuity with ordinary parental responsibility.  So I'm happy to have a focus on selecting in, but what I don't want us to do is suggest that we have, therefore, somehow it upon the weightier question.  It's not weightier.  It's just different and deserves attention in its own way, but I'd want us to be careful how we formulate that.

CHAIRMAN KASS:  Thank you.  A point well-taken.

Paul McHugh.

DR. McHUGH:  Well, maybe I can slip in here.  I'm not sure it will be helpful, but it kind of backs up what Gil is saying.  I believe that this is a very important enterprise we're beginning here, and that the general principles that will come out of this will teach us a lot about what we are preserving in the ethical principles related to biotechnology today.

And again, because I'm a clinician, I'm always seeing the down sides of all kinds of things, and I want to emphasize that, therefore, I'm very conservative about any of these enterprises that want to enhance things simply because I've seen how that concern with enhancement, and particularly the concern with the biological nature of people begins to get folks to look at their vulnerabilities or the little bit of red ink that's in their life and neglect all of the black ink, all of the wonderful assets that they have.

And I think I've talked to the group before about the fact that, again, in my clinical life at least once a year I have very talented parents bring to me a young man or woman that is not living up to Daddy's achievements.  They're usually people who have IQs of 140 to 150 and their kid has an IQ of 125 because there is this reversion towards the mean.

And they're upset that the kid is not, you know, valedictorian.  Now, this kid, let me just describe for you.  This kid is six foot, two.  It's from mid-court nothing but net, you know.

(Laughter.)

DR. McHUGH:  He's absolutely the most attractive soul you can imagine and they're wondering, well, why isn't he valedictorian, and my job is to persuade them that their other things in life and other things about this person that they have to appreciate, and that I'm appreciating just by meeting them.

And my job, and by the way, it's not to hard eventually to persuade them that there are many, many assets that need to be emphasized.

I believe, in fact, that it goes beyond this little, small story that I'm telling you.  I believe that part of our problem for young adolescent people, particularly young adolescent people who are high achievers themselves, who are already with 1600 SAT scores and the like, that somehow or other in the challenges that they face ultimately in places like Cal. Tech. and MIT, they begin to believe that somehow that they don't quite measure up, and many of them want to check out because of that.

And I think that has come about in part because of our assumption that we are simply machines, that maybe we don't have all the right gears for, and the suicide rate amongst adolescents, as you know, has gone up very remarkably, and it has gone up, by the way, amongst very talented adolescents.  And places like MIT are very much suffering from and trying to figure out how to work on it.

So I'm very anxious for us to talk about the goods of human life itself, emphasizing that the assets are important to preserve even as we think in terms of what can we do somewhat to help people.

Ultimately what am I trying to do?  Am I trying to teach people? 

I am trying to teach them to — well, Bill put it so well — to savor their lives and the like, and I'd leave you with perhaps an old chestnut about enhancement.  Just maybe many of you know it.  So it's a corny story.

It's an old Yogi Berra story.  You remember Yogi Berra, the Hall of Fame catcher, and one day in a long, hot game, a batter came to the plate, and he was a religious person, and he was blessing himself three times, and Yogi said to him, "Why don't we just let God watch the game today?"

(Laughter.)

DR. McHUGH:  And to some extent I want to tell people, "Can't you watch the game and see what happens?" with the emphasis, therefore, on the parent to say, "You have a lifetime experience with this gift that you have.  At first you're going to be spending a lot more time monitoring and shaping and advantaging the child, but ultimately you are going to be somebody who watches the trajectory of this life in a very special way, a way of concern but in which you do not any longer fool with the instruments but let the life go on enriching all of us."

And so I think this is a very important part of our things to talk about.  It's as important as any technological thing primarily because of what kind of a message that we want to give people.

CHAIRMAN KASS:  Thank you.

Michael.

PROF. SANDEL:  Well, I, too, think this is a very important topic, and I think the organization is a good one.  One question I had really, and I don't know if this is the time to delve into some of the actual ethical analysis that this question raises, and my question has to do with, well, one that we have discussed here on other occasions when we've talked about sports, which is:  why does it seem okay for an athlete to improve herself through training, but not through bioengineering?

We've wrestled with this question before, and in trying to get at the heart of the ethical issue we've put to one side obvious safety considerations, and we've also discussed the question of fairness in the competition.  Would it give an unfair edge if some had access to the bioengineering but not others?

But we've agreed that there is a further moral question.  Assuming it were available to everyone and assuming it were safe, what would be wrong with bioengineering of athletes?  And why is it disquieting in a way that training regimes which enhance are not disquieting?

Now, one answer to that question locates the moral crux in the idea of human activity.  This is what you've referred to here, Leon, and also on previous occasions.  And the answer goes something like this:

What's wrong with bioengineering superior performance is that it undermines the dignity of the performance of the athletic excellence by detaching the doer from the deed, by introducing what you've called on various occasions the kind of biological magic so that the athlete who trains rigorously is in some ways less alienated  from her performance than the athlete who simply takes a pill or has an injection of a gene of some kind to enhance the performance.

And that you've argued — and here I just really want to raise a question about that argument — that's the moral crux of the issue, the alienation of the doer from the deed, and here I have two questions really as a way of inviting you or others to say whether this really is the moral crux of the disquiet.

Between training and bioengineering to improve performance are other means that normally we don't find disquieting, like taking vitamins or improving nutrition.  But taking vitamins and improving nutrition is a way biologically of improving ones body in a way that is as much biological magic as the gene vector, well, except to those who may be medically informed and who might be able to give us, as Dan could, a detailed account of how the improved nutrition or this vitamin actually leads to improved performance.

But then Dan or others could also give the same explanation of the gene vector.  So as far as the idea of authenticity, being in touch, the doer and the deed, keeping them in contact, is there a difference or does this analysis suggest that maybe we should feel disquiet when some athletes undergo nutrition and vitamin regimes?  That's one question.

The other question is:  why do we worry, if we worry, about the dignity of human activity, about avoiding the alienation that comes when we indulge in biological magic to get a result rather than training?  Why don't we worry about that in the case of healing?  Why is that only a concern in the case of enhancing?

If someone needs surgery or a medical procedure to heal an illness or a disease, why don't we worry about the dignity of human being in the world, activity in the world then?  Why don't we worry about the  biological magic of medical therapies?  Why is it only a concern in the case of enhancement?

PROF. MEILAENDER:  May I just piggyback on that? 

CHAIRMAN KASS:  Please.

PROF. MEILAENDER:  I'm not going to answer his questions.  I just want to exacerbate them in a way.

But to come from the other side, in a sense, from the point of the person who has used the genetic enhancement, it's just worth noting that I think it would be true to say that at least in many cases this wouldn't eliminate the need for continued training regimen, for working on your skills, for plotting strategy for all sorts of things.  It wouldn't mean that you were necessarily interested only in winning.  You could still enjoy the performance itself, though perhaps at a level you couldn't otherwise have done.

So that, in fact, many of those things that we probably have no objection to would still continue to be part of the athlete's package even at an enhanced level, and that to me, as I say, it only complicates the question still further.

CHAIRMAN KASS:  Dan and then Mary Ann.

DR. FOSTER:  Just one question.  I don't like the analogy — I would rarely disagree with Michael about anything — but I don't like the analogy of healing or treatment as part of the thing because what medicine is doing by its treatment is to try to prevent destruction of the organism, whereas the use of these other techniques that you call biological magic are to enhance superiority.

So I don't think that that aspect of it is equivalent along those lines. 

The only other thing I would say is it's pretty interesting that the sports community itself in some sense intuitively has said we need to keep the competition competition without enhancement.  And so they penalize if you take adrenal steroids or that you take Ephedra or, I mean, if you've got an allergy or something, you know.  I mean, you've got asthma, and you get eliminated from the Olympics because you might get some more, you know, adrenalin equivalent to do that.

So we have a very broad aspect of human experience.  I mean, the East Germans, the horror of what they did to those women swimmers and so forth was just awful, but that community which so far as I know is not primarily involved with ethical issues; they're involved with winning, but they want to win fairly; have said that this is something that intuitively seems wrong to them.

At the end of this document, you know, there's a statement about the computer chess player versus the human chess player, and in some sense it's a little stretched, but in some sense it is not about the game anymore because the computer does not use the same — it doesn't sweat.  It doesn't intuit it, doesn't watch to do that.

So it's interesting to me that the participants in the issue of sports have already decided universally, and when they're not doing it, there's huge criticism about the fact that they're not eliminating enhancers.

Now, you could argue if it's available to everybody, then it would restore the competition.  You know, if everybody took the same amount of adrenal steroids and so forth, then you'd get the competitive thing there.  But it is interesting that they sort of sensed, and I have to say that I think I sort of sense that there's something flawed in this thing beyond.

I think training is different.  I mean, I just think it's intuitively different because it's a matter of work rather than a matter of making something biologically happen.

And I should say as a physician, all of you know that there are very serious side effects.  People who use steroids and so forth die earlier, you know.  I mean, the men's testes shrink.  I mean, there are all sorts of—they build up muscles, but there are great prices that are there, too.

So I just wanted to make those two points, that I don't think we ought to use the biologic magic in medicine as an equivalent to that.

PROF. SANDEL:  Just, if I may, a point a clarification.  I was unclear when I spoke.  I did not mean to equate medicine with sports enhancement.  To the contrary, I'm for medicine and I'm against sports enhancement.

What I was suggesting was that the reason that Leon has offered for objecting to enhancement is problematic because if it were applied to medicine, it might condemn medicine as well as enhancement.

So I was trying to identify a feature of the argument against enhancement, not to suggest that medicine is the same as enhancement.

DR. FOSTER:  That is one of the most gentle responsive criticisms I've ever heard.  What he said is I didn't understand a word he said, and I wouldn't have said what I said if I'd really understood him.

(Laughter.)

DR. FOSTER:  And so that's gentle.  That's putting the blame on the receptor rather than the agonist, you  see.  I mean, I've got perfectly good agonists here, but my receptor was not in the right mood.

So I accept.

(Laughter.)

CHAIRMAN KASS:  Well, that kind of generosity only moves me to come to your aid, sir.  You shouldn't be so—Mary Ann, do you want to get in first?  Because I'm accumulating a number of things on the substance that I'd like to respond to.

PROF. GLENDON:  Yes.  Well, I want to go back to Michael's presentation where he said that training regimes are not disquieting.  I don't think we can say that easily, and reflecting on that caused me to think that perhaps although I see why we took athletics as an easy example, I think maybe athletics and the role it plays in our society, maybe it's not such an easy example.

I'm thinking of the story of Mickey Mantle as a young boy.  His father took him out.  He had no childhood.  His father took him out in the back yard and relentlessly pitched to him day in and day out and created a certain kind of being who was a very skilled athlete, and a human being who was lacking in several qualities that one might think associated with a full human life.

And I think from what one reads about the training of tennis players and Olympic athletes, there are many, many young people whose childhood has been taken away from them and to the point where I'm not advocating this, but suppose there were a pill that had no side effects.  Which would be better for the realization of a full human life for an athlete, training day in and day out or popping the pill?

CHAIRMAN KASS:  Very nice.

Before there are more, let me make some kind of response.  First of all, we're really wrestled very hard with these distinctions, and part of the discussion is to try to figure out, well, why are biological technical means different, and there is some discussion about training and various other things.  And you line these things up on a continuum, and it's sort of hard to know the boundary, especially when you recognize that anything that you do brings about a transformation in the body, and the mechanisms might be very similar.

And putting this not with a biotechnological focus but in the context of the human desire for superior performance, it enables one to cast reflective light exactly on the kinds of excesses of training.

I recommend this to everybody.  While working on this stuff, we rented the video ofThe Chariots of Fire, which is for those of you who don't know it at all really one of the great movies in the last couple of decades, and it's about the 1924 Olympics in which one of the British runners is chastised for having a trainer, which was absolutely unheard of in British amateur athletics to that point.

And what I had forgotten was the Americans showed up at this Olympics, all of them with trainers and already engaged in a highly methodical approach to the body. 

When Ted Friedmann was here and he was sort of mournfully speaking about the death of the athlete understood as the amateur acting out of kind of love of the activity and the concern for victory and then ultimately the separation of the achievement from the achiever.  So the only question is how far did the ball go, in which you begin to turn your performers not so much into athletes as entertainers.  The activity gets to be deformed.

You can see that with training.  I mean, you can see that with a certain kind of excess of training, and I think the point is very well taken.

And the next point is to say that the analysis ought not to be to try to definitively answer this question, but to try to provide the kind of language for the ongoing consideration of this question, and we've gotten in the discussion multiple possible reasons for being troubled by this.

To defend the argument, and this would take a long discussion and maybe we should just start, it does seem, to me to come to Dan Foster's aid, one could say that in the case of providing insulin to diabetics, one is coming to the aid of a body seeking to heal itself, and that while the mechanism of action is not known to the patient and from the patient's point of view it might just as well be magic, it nevertheless is an attempt to serve a particular kind of given goal and to come approximate the way in which the body does this on its own.

Whereas in these other areas, it seems that ordinarily we get to be excellent by activity in which we sense the connection between practicing the piano and getting good at play, which there is a kind of connection between the mode of improvement and the thing being improved.

In fact, you improve in the various activities that you train in, and to that extent on the point of human experience, there's a certain intelligible relation between training and the thing that is perfected.

And to that extent there does seem to be some kind of disruption, though I want to acknowledge Gil's point.  When it's not talking about giving somebody a pill that's going to make them out to be able to hit the three point shot, training and practice still will be necessary.  So it's not simply a magical pill that replaces that.

But I do think healing is—

PROF. SANDEL:  Healing is different you're saying because it's a worthier end than souping up performance, but that has nothing to do with the—

CHAIRMAN KASS:  No, I don't think I'm saying it's a worthier end.

PROF. SANDEL:  Then what's the distinction exactly that you have in mind?

CHAIRMAN KASS:  I'm saying that one enters into the healing activities and supplies biologicals to the body to aid the body's own self-healing process.  Look.  We function all the time without awareness of the biological processes that lie beneath all the things we do and experience. For example, we speak and make ourselves understood without being aware of everything that makes it possible for us to speak, and that takes place beneath the plane of consciousness. Of course, a scientist can try to analyze the biological mechanisms, but from the point of view of human experience, if you stop to think about it, speech and understanding remain absolutely wondrous and mysterious, inexplicable in the language of biology.

I mean, who knows how it is that little things of sound fly from over here across there and carry units of intelligibility?  These are the same biological processes that are in the same sense that we use the term "magical." 

So I grant you that this invites a kind of reflection of the way in which our bodies are somehow mysterious to us, but there are many ways in which we go about improving our ability to use our bodies that proceed by activities that in their human import are intelligible.

If I practiced the piano, God willing, I would get better at it as a result of practicing, and similarly in various kinds of training.  So that one sees through the ways in which we use our bodies deliberately to improve the activities, there is a certain continuity between agency, accomplishment, improvement.

PROF. SANDEL:  And so what about the vitamins or good nutrition?

CHAIRMAN KASS:  Yeah, look.  I want to acknowledge continuity.  I don't think the disquiet depends upon one's somehow crossing some kind of bright line and saying you're in a terrible—although I could say vitamins and good nutrition are—

PROF. SANDEL:  Would you say a little alienating?  It's a matter of degree.  So they're a little alienating and, therefore, a little disquieting, but not as much so?

CHAIRMAN KASS:  You'd have trouble getting me on good nutrition and vitamins.  I mean, it seems to me one could make the case for good nutrition and vitamins just in terms of being healthy and fit.  If the question is whether I should give up eating a healthy diet in order to eat only those things that will make me a terrific wrestler, if any such there be, then I think you're in a different territory.

I want to acknowledge the difficulty, Michael.  I don't think one's got a kind of bright line on the other side of which you have the principal basis for disquiet, but this is a struggle, I think, to try to figure out.

And the other alternative is to say control as such is bad.  Let God enjoy the game today.  And that merges in with the hubris objection that you've raised previously.

DR. FOSTER:  I only want to make one response about vitamins.  Most of that is mythology, as the Institute of Medicine said.  What's characteristic of vitamins, they act in very tiny quantities and they're not needed above that, and if you eat an average American diet, everything is so filled with vitamins that you can't be vitamin-depleted.

You know, if you're a Zen Buddhist, you know, you have to do that.  So most of this stuff that the athletes gulp down goes out in their urine within 24 hours.  So I mean, what they're doing is they're trying to enhance the health of the sewage or something, you know.  Like that's—

CHAIRMAN KASS:  And the vitamin-producing industry.

DR. FOSTER:  But it has a big psychological effect.  Now, there are exceptions, but then when the exceptions are the vitamins are not acting as vitamins.  Vitamin E may be an antioxidant and keep you from getting atherosclerosis, but it's not acting as a vitamin.

So this is mostly mythology.  So the enhancement is due to the psychological view that I'm building myself up, and not from any biological magic in that sense.  So I would say forget about the vitamins.  Okay?

(Laughter.)

CHAIRMAN KASS:  Gil, still on this point?  Yes, quickly.

PROF. MEILAENDER:  Yes, two comments.  One, we've tried to get, in the Beyond Therapy project, we've tried to get beyond the therapy enhancement distinction, and I do think that that distinction does not fully work and does break down at some points.

But there is a sense in which maybe we shouldn't try to get too far beyond it because it has reemerged in a way.  Why good nutrition?  Health, you know.  It has got nothing to do with enhancement per se.

And so in our, I think, correct effort to see that that distinction is far more complicated than it has often been thought to be and that it will not just in itself solve the questions we're taking up, we should be careful not to go too far because, in fact, it just reemerges at certainly places.

CHAIRMAN KASS:  Right.  Point well-taken.

PROF. MEILAENDER:  And we need to see that.

The other point I just wanted to make—

PROF. SANDEL:  But then, Gil, just to enter, that's then back to the end.  The end of health is worthier than souping up athletes.  It has nothing to do with this particular thing about the dignity of human activity and about making the individual's agency less humanly or experientially intelligible.  No, it's that we consider health is a higher end than souping up athletes.

PROF. MEILAENDER:  I don't know about higher.  See, it's the worthier/higher language.  We probably agree at some level, but it's pretty low to the ground good, in fact, in some ways.  It's not the kind of thing I use "worthy" in connection with.

May I make one other related point?

CHAIRMAN KASS:  Yes, please.

PROF. MEILAENDER:  I don't generally disagree with Mary Ann.  I agree with her about 12 year old gymnasts, say, or something like that, but it is the case if what we're interested in is thinking about superior performance that almost all superior performance requires an imbalanced, an unbalanced life in some respects.

And I would be sorry not to have been able to watch Mickey Mantle do what he did as well as he did, and I'm old enough that I did watch him.

Now, he paid a price for it.  I can't say that he should have paid the price for it.  On the other hand, the superior performance might not have been possible without it.  So I'm always unsure what I think about arguments about a balanced life.

Most of the good things in the world come from people who aren't so balanced.

CHAIRMAN KASS:  Jim Wilson and then Bill.

PROF. WILSON:  I want to try an argument about which I am most unsettled.  So I plead with you not to spend the next hour pointing out the obvious faults in it.

At the end of the paper, the author mentions watching Gary Kasparov play a computer, and Gary Kasparov is one of the great chess geniuses of all times.  There was no doubt in my mind that eventually somebody would invent a computer who could beat him, and it did.

But that was an interesting thing to watch, but then the author of the paper goes on to say, "Would we watch two computers play chess against each other?"  I don't think so.

So there's something about the humanity of Kasparov that is important.  No matter what he went through in childhood suppression and growing up in an oppressive state and learning chess as if nothing else mattered and leading so far as I know a monomaniacal life, he was a human being.

So that there's something about humanness that counts, but that then raises the question of therapies of various sorts that are designed to enhance it, and I want to say that I'm not sure we should hold constant the possibility that all enhancing therapies are equally safe because as I think about this, I want to make distinctions. 

People take adrenal steroids, and as  Dan has pointed out quite correctly, these have some very adverse effects and objecting to this behavior on the grounds that you're sacrificing your humanity in order to advance your ability in one particular area, that is to say to confront a middle linebacker of the San Diego Chargers, seems awkward.

But on the other hand, suppose you have asthma and suppose you can take a drug that eliminates the asthma or some other thing, which is on the prescribed list, or suppose you suffer from cluster or migraine headaches and you take drugs for that or suppose you have other things for which you take drugs which have some side effects, but not the kind of side effects that are disabling. 

It seems to me that in time society might drift in the direction of saying we're going to loosen up the list of drugs that you cannot take, and we are going to be more precise about specifying those drugs which in some sense are inhuman.  That is to say if you take them, you are courting almost certainly extremely adverse side effects which diminish your humanity, and to allow more drugs that solve particular problems and have an acceptably low rate of risk.

Now, since I have thought this through only in the last 12 seconds, I'm sure that by tomorrow morning I may be reconsidering my remarks, but I don't want to assume that we have to analyze this on the assumption that all drugs are safe because all drugs are not safe, and all drugs never will be safe.  And we have to realize that one of the reasons we are concerned about this problem is that the unsafety of some drugs makes it a little bit more like watching two computers play chess.

CHAIRMAN KASS:  Thank you.

Bill Hurlbut and then Elizabeth and then Paul.  Bill May, I'm sorry.

DR. HURLBUT:  Dan mentioned the East German swimmers.  I think it was about 1964 that the first real use of steroid drugs became evident in the Olympics, and I remember reading an article.  One reporter said to the coach of the East German swim team, "Why do your swimmers"—this is a female swim team—"why do your swimmers have such low voices?"

And his response was, "We didn't come here to sing."

And it raises the issue, well, what is the overall purpose of a thing anyway.  And I think that's the context in which we have to look at this kind of an overspecialization, which is what enhancement is aimed at.

I keep saying in these discussions, and I think we need to keep this in the forefront of our minds that what are the purposes behind enhancements anyway.  Competition can have both a noble and a very negative overtone to it, and yet I think we have to bear in mind what the purposes of human existence actually are, and what are the qualities that we as biological beings have that are special to both our functioning and our sense of meaning.

And I keep coming back in my mind to the meaning of allowing yourself to be specialized, which is what Gil was referring to.  A lot of great things come from narrowed, focused specialization in human existence, but something else really great comes from not specializing, and that is a broader, what you might call a breadth of comprehensive engagement with the world.

And here I come to think of what's called focal dystonia, which is a phenomenon you see among what's common among concert pianists or classical guitarists, where they work with such focused attention on a single task that they actually become semi-paralyzed in their performance of that task, and they have to give up—Loren Hollander, for example, a famous pianist, developed focal dystonia, and he couldn't play the piano even though he had been a very successful child prodigy.  And he realized that what he had done was he narrowed his life in such a way that he actually destroyed the breadth of his performances and his ability to perform even in a specialized way.

So the lesson I would take from that is that what is strong—the reason the hand can do what it can do is because it has a broad experience and then can apply that broad experience to a particular narrowed function.

Maybe Paul will have to help me out with what I'm trying to say here, but likewise taken in its breadth, the human fullness, if you're coming to do something more than sing and win, if you're coming to have a full, rich, human meaning, which we are now coming to call a spiritual meaning in our society because that's lifted us into a pluralistic realm that is also yet related to something larger, transcendent that goes behind the individual, but isn't specifically religious; if we're going to seek that breadth of comprehensive significance, then we have to specialize in such a way that it is part of that and not an isolated focus that destroys the meaning of the whole.

I don't know if I got that across really, but dignity to me means fullness, and fullness means a truly meaningful, engaged purpose, not just winning.

CHAIRMAN KASS:  Thank you.

Elizabeth, Paul, and Bill.

PROF. BLACKBURN:  A general comment on the organization.  I thought it was very useful to bring it into the large questions like this and not break it down just into technologies.

And I had a thought which struck me upon deliberating on this and also as our discussion proceeded this morning, and I'm somewhat disquieted by this term "magical" and "mysterious," not that I want to deny the complexity in our lack of understanding of a lot of the processes that go on, but there are a couple of things that I didn't really like about this, and one was that it sort of implied that there is sort of an abdication of the need to really think and grapple intellectually with what's going on.  Somehow if you just throw it into "magical" and "mysterious," that sort of says, well, okay, we don't need to think about it anymore.  And I think that's a sort of anti-intellectual thing that I felt uncomfortable with.

And then slightly implicit, I thought, in some of the discussion and perhaps the writing was the idea that, well, it was mysterious.  Dan would understand it, but those simple athletes wouldn't, and I thought that's sort of, you know, perhaps even a little condescending to sort of imply that, oh, it's mysterious and magical to those people because they can't really think about these things properly.

And so I think perhaps avoiding those terms as much as have been used would be helpful because I don't think we want to just, you  know, abdicate thinking about them.

CHAIRMAN KASS:  A quick response.  Anything that smacks of being anti-intellectual will come out.  There is notoriously a disjunction between the way science understands things and the way human beings on the plane of human experience understand things.  These are two different languages.  It's a vexed question of how these things fit together, whether you take it up under the mind-body problem or consciousness or what have you.

And when Michael said that Dan would understand this, I think he was saying he could understand the mechanism of this, but I'm not sure that the mechanism of it is identical to the experiential knowing from the inside.

One can find a way to say that without appearing to be insulting, and on the subject of mystery, this is, I suppose, a long discussion and not for here, and the question is when scientists use the name "mystery," they usually mean it as that which we do not yet understand, but that in principle everything is capable of having an explanation.

And I would at least like not for the document, but for the continued reflection of everyone around the table to wonder whether that's true.

PROF. BLACKBURN:  I think perhaps "magic" is the more objectionable terminology.

CHAIRMAN KASS:  Indeed.

PROF. BLACKBURN:  I see what you're saying about "mystery," but "magic" to me sort of implies something, you know, that's the last resort, is to call something "magic."

CHAIRMAN KASS:  Terrific.  Thank you.

Paul McHugh and Bill May.

DR. McHUGH:  I have only a couple of things that I want to add to what I said at the beginning about nature itself and, in part, in relationship to what Mary Ann and Gil were talking about, and that combines the issue of science and, interestingly, simple observations about human nature.

It turns out that child psychiatrists have observed the schools that do best with the children are the schools that offer a smorgasbord of things for the kids to do, not just reading and writing and athletics, but dance, art, other things.

And it turns out that the children themselves seem to become thriving adults if at some early time in their life they discover that they were a success at something, and you never know what somebody is going to be a success at.  So, therefore, lay out before them music, dance, art, reading and writing, math clubs, stamp clubs, train clubs.  Okay?

And it works out that they do well, and then it comes around to the other side, to this Mickey Mantle issue.  It turns out that as you see people emerge as kids and come into their adolescence and early adulthood, they begin to narrow down the things that they want to do, and there is a sense that everybody, at least the happy ones, put themselves through boot camp at some point.  Okay?

I've got to do this even though it means I'm going to have to give up a lot of other things because, darn, I want to do it at the best level I can.  I want to play every day at the big league level, and to do that means I've got to do something else, give up something else.

And those two things are natural, and we as parents or as other people want to encourage that to happen for all of our kids.

CHAIRMAN KASS:  Thank you.

Mary Ann, to this?  Okay.

PROF. GLENDON:  I just want to emphasize and partly in response to what Gil said that there's a big difference between a child's reaching the level of maturity where the child decides he or she wants to go through boot camp and having the parent put that child in boot camp from three or four years old.

And so this general question, and we shouldn't forget that this general question is coming under the heading of better children and under the heading of big questions about are we doing things that are transforming the meaning of parenthood, parental responsibility and childhood.

CHAIRMAN KASS:  Bill May.

DR. MAY:  I wanted to return to the question of the spirit of reflection in this area.  I've spent 52 years teaching.  I'm finished with it now in the classroom, and I just think that work on these two topics that I've had a little chance to look at would be wonderful teaching material. 

So much medical ethics has been quandary ethics.  I mean, you identify a problem, and then you hunt around for moral principles that will resolve your problem, and you go from one thing to the next and some other problem.

And to think reflectively about better children and excellence of performance offers a kind of meditation on the human condition that I think would be very attractive.

And the word "mystery" was used, but I think it offers the possibility for the stirring of wonder in young folks, the kind that I've taught across 52 years.  I mean, we're not doing this for the sake of developing a preamble to regulations.  We're doing this to provide an educational resource, it seems to me, and it seems to me that what I've seen so far would really allow for that.

Now, just a couple of comments on the parenting and then excellence of performance.  On parenting I think I may have mentioned this earlier and maybe it's time to close shop if one begins to repeat things that one said earlier, but I overlapped one year with W.H. Auden at Smith College, my first year of teaching, and we happened to be in a faculty show together, and so I got to know him, and he was talking about the pressures that American children were under as opposed to English children, and he said in America the very act of being an immigrant nation, except those who were forced to come here, had a huge pressure in the direction of outstripping your parents.

And we place a lot of this in that setting, to produce better children, and behind that lies the whole aspiration that people came here maybe not because they thought they were going to produce better children but a better environment that would allow their children really to outstrip, and they put up with very considerable sacrifices in many cases of a strange language and all of the rest that tended to shrink the parents and justified this sacrifice in terms of what it would do for the kids.

And we've not only been an immigrant nation, but in a sense, a perpetually migrant nation.  The mother ship then became the education that would be offered that would allow kids to move out of the ghetto neighborhoods to which my grandparents came, and then you move out of that.

So it seems to me it's a very worthy enterprise to deal with this whole business of producing better children and then talking about what happens in the setting of biotechnology that feeds into this very fundamental aspiration in the kind of society that we are.

On the other issue of excellence of performance, what I've seen of it especially in theater, by accident in my own life, so often you see the need for a double gift of both the talent and a psyche to support the talent.  And one talks about training the talent, but there's the need for the discipline of the psyche.

And it's very interesting.  One is talking not simply about things that will enhance a talent, but those things that will sustain a psyche to support this talent under special pressures, and they are huge pressures, especially public performance.

What was it in the setting of

Greece?  Truth, alethia, moving out into the unconcealed, and that's a terrific transition from life that's concealed to life that is displayed.  In the sense of being tested by that, you show what you are, and it's a very difficult and demanding task.

And so the huge temptation to find supports that will allow one to do this, and then not psychic supports, but then instrumental supports and the huge embarrassment for that bat to crack and splatter and cork to be revealed, and so what seemed to be displayed is very unfortunate.  In so many ways an utterly admirable performer, and I tend to accept his story about that.

(Laughter.)

DR. MAY:  But it's very interesting him blurting out as opposed to stepping out into unconcealment and showing your stuff as a performer.  It's a terrific collapse, and behind this, behind what I've looked at here, I couldn't help but think of Montesquieu.

And I had to give a lecture once at Meilaender's institution, Valparaiso.  It's before he got there, and it was on the honor code because that was a big thing at that school, and so I tend to read Montesquieu on that, and I realize the difference between the competitive meritarian (phonetic) society where in cheating you perpetrate an injustice on somebody else.

In the setting of aristocratic past, in failing to live up to the honor code, it's not simply an act of injustice against others, but an act of self-diminution.

And I think this document interestingly deals with that.  It may end up rather too much harkening to an aristocratic past.  The hand and spirit of our Chair shows through in this.

(Laughter.)

DR. MAY:  But so be it.  I found what I've seen so far very, very interesting and would provide just endless opportunities in the classroom that I would delight in.

CHAIRMAN KASS:  Thank you very much.

A child of immigrants appreciates the suspicion cast upon him of aristocratic sympathies, but that's all right.

Michael Sandel.

PROF. SANDEL:  Well, what I have to say has very much to do with what Bill has just pointed out, to do with the aristocratic flavor of the main argument of particularly the section on performance, superior performance.

And what I have to suggest is  not that that's misplaced or wrong-headed or misguided, the emphasis on excellence, but it does raise a question about how relevant the sports metaphor is to the wider society.

Now, there is a powerful intuition that there is something to the metaphor, something powerful to the metaphor of sports and a meritocratic (phonetic) society such as the one we live in, and I think part of what underlies that intuition is the sense that there is a ratcheting up of the pressures, and Bill spoke of pressures here, within the American meritocratic society, and that may be why parents are trying to enhance their children or athletes to enhance themselves.

There are the pressures there, and we also sense a ratcheting up of the competitive pressures in sports.  So there is a prima facie analogy.

But if the reason for our disquiet about sports enhancement, biotech sports enhancement, depends on this aristocratic or Greek picture of excellence, then the analogy has less force, might have less force for the kinds of enhancements that people are tempted to pursue to deal with the pressures of a meritocratic society for the following reason.

There are really two dimensions of sports that are at stake in performance enhancement.  One of them is the honorific dimension having to do with the way in which sports honors superior virtue and excellence, and the other is the competitive dimension which has to do with winning and losing, effectiveness.

Now, the argument here that tries to locate the moral crux of our disquiet in sports focuses almost entirely on the first, on the honorific, on the excellence.  That's the aristocratic; that's the concern with excellent display, the honorific dimension of sport.

But if it turns out that in a meritocratic society what leads people to strive for enhancements is not that they want honor and recognition, this Aristotelian virtue, but they want to get ahead.  They want their kids to get ahead.  They want their kids to get into the 92nd Street Y preschool.  They want their kids to get into Ivy League colleges.  They want their kids to be well-equipped.  They want for themselves to be able to compete effectively for jobs and under conditions where the pressures and the rewards and the stakes are more intense.

Then if that's what's animating the drive to enhancement  in the larger society, then to show that this honorific thing is at stake isn't going to be persuasive.  It's not going to be an apt metaphor because it takes that part of sports, the honorific rather than the competitive that's least relevant to the striving and the ratcheted up pressures that we see in contemporary meritocratic society.  That's about, you know, effectively getting admitted, getting hired, getting ahead, making a living, competing in a kind of ratcheted up thing that doesn't have to do with honorific dimensions at all.

So if you're right, and you may well be right, if you're right that this account of the dignity of human activity and so on and the analogies that come to mind are painting, dancing, building, designing, writing, singing, these all have to do with excellence, honor, recognition.

But that's not what's animating the drive to enhancement in a larger society, and so that may suggest that the analogy, the prima facie analogy between sports and meritocratic society breaks down if the reason for the disquiet is wholly cast in these aristocratic, Aristotelian, virtue-based terms.

CHAIRMAN KASS:  That's superb, Michael, and I think further rounds could reflect the power of that.  We have to add something.

And the sports, one is not uninterested in excellence.  I think everybody is, and Dan Foster's comments—I think it was Dan's comments—about how the people in the sports somehow don't want this, they could if they wanted to or if they were only interested in having people hit the ball farther.  Then they would legitimate these things. 

So there is some kind of concern for the, for lack of a better term, the genuineness of the excellence there even though it is a competitive activity and you might think that there would be reasons why the drive for competition and bringing more fans to the park, which is all to much on their minds anyhow and has led to certain other corruptions of the games, why they would overturn that.

But I think the kind of striving that you mentioned has to be dealt with in addition to the question of the concern for excellence as such.

 

SESSION 7: PUBLIC COMMENTS

CHAIRMAN KASS: Look.  We have come to—only five minutes late—we've come to the end of the time allotted for this session and the time for the public comment, and we have four people who have signed up for public comment, and if Council is willing, why don't we simply stay at the table rather than take a break, and then we can leave promptly by 12?

For people who are with us for the first time, the house rules are public comments, by all means welcome, but there is a five-minute time limit on the comment to be made, and the first name on my list is Allison Hoffman from the National Partnership for Women and Families.

Ms. Hoffman, welcome and please come to the microphone.  It should be on.

MS. HOFFMAN:  The National Partnership for Women and Families is pleased to submit public comments to the President's Council on Bioethics for this meeting of July 24th and July 25th, 2003.

The National Partnership is a nonprofit, nonpartisan organization that is working to promote better health care for women and their families.  The National Partnership for Women and Families strongly supports allowing research using somatic cell nuclear transfer, commonly known as therapeutic cloning.

The purpose of this technology is to develop treatments for diseases and give millions of people access to life saving therapies using their own DNA.  Medical research involving therapeutic cloning holds tremendous promise for patients with countless diseases.  This research could produce treatments for diseases particularly affecting women, such as breast and ovarian cancer, arthritis, osteoporosis, and a range of genetically based diseases.

In addition to their own health concerns, women are the primary health care decision makers and care givers for their families as well.  Women continue to be the primary care givers for elderly parents, children, and family members with chronic or degenerative diseases.

SCNT offers hope to women struggling to care for parents with Alzheimer's disease or suffering after a stroke, children with juvenile diabetes and husbands with heart disease.  Any restriction on biomedical research, such as scent, jeopardizes this hope by threatening to delay or prevent important medical advances and sets a dangerous precedent for regulating medical research.

Instead the National Partnership supports measures that will maximize the benefits of this research and minimize the risk to women and their families, as well as society as a whole.

In establishing federal or state guidelines, we support policy proposals that ensure that all research, including therapeutic cloning, perceived with strong safeguards in place to protect individuals from unscrupulous practices.  We believe that therapeutic cloning research should be done only under the highest ethical standards with strong informed consent requirements, measures to protect women from exploitation, and a prohibition of undue financial inducements to donate eggs.

The National Partnership, along with countless other women's health advocates have worked for years to make up for researchers' past neglect of women's health.  In our pursuit of better information, treatment and cures for women and their families, we must insure that the newest and most promising techniques are available to those same researchers.

Thank you for your consideration of our concerns on this critical issue for women.

CHAIRMAN KASS:  Thank you very much.

Next, Sean Tipton from the American Society for Reproductive Medicine.

Welcome.

MR. TIPTON:  Thanks.

I would point out to everyone that tomorrow morning and Sunday morning you have an interesting opportunity to observe a convergence of the two topics you dealt with this morning, and that is in the person of Lance Armstrong as he pursue a fifth victory in the Tour de France.

You may recall Mr. Armstrong had testicular cancer, advanced testicular cancer, and some of the controversies upon his return were some question of enhancement versus therapy, and if he wins on Sunday, I'm sure you will see him with his children on the platform.  Those children were conceived with the assistance of ICSI.

So at least that's the spin I'm going to give my wife tomorrow and Sunday as I try to watch that on television rather than take the kids to swim lessons or Sunday school.

(Laughter.)

MR. TIPTON:  So we'll see how that goes.

Among the topics you all discussed at some length yesterday and today was the question of outcome studies and what the federal government can and cannot fund and those kind of questions.  I would point out that the NIH and the NICHD do, in fact, fund some limited outcome studies.  They have a trial underway now where the main site is at Baylor down in Houston looking at outcomes for ICSI children.

So I think there's certainly more that could be done there, and I think in terms of other directions to go, I think there is a huge, huge difference between an NIH funded multi-center outcomes trial and a mandatory reporting or tracking of all embryos created and, indeed, all children conceived and born.

I think those are very, very different animals, and those differences need to be considered with some care.  You have some significant privacy concerns if nothing else that I think you need to deal with in a little bit more explicit manner.  The outcomes work that we do with the CDC in terms of tracking the number of cycles of ART performed and how many of those lead to live births or multiple births of children is very difficult to do, in part, because infertility patients like to put their infertility experience behind them as soon as possible.

So I think doing other long-term studies has some significant obstacles.  Having said that, we are very supportive of more outcome studies, and I would comment to the committee looking at the recent data from the European Society of Human Reproduction, which I think only now was an abstract at a meeting and not yet fully published, but should be out in a few months, and we think that outcome was very important and very promising.

Finally, I would like to wish a happy birthday to Louise Brown, the first IVF baby who turns 25 today.  I think that's a very significant milestone, and as we reflect upon that milestone, I think it's worth noting and remembering the huge hue and cry and, indeed what in some ways now looks to be a little bit of hysteria that accompanied that birth around a technique which we are now nearly a million children into.

And I think maybe with a few notable exceptions most of those families are very grateful that the technique was invented or perfected by Professor Edwards and Steptoe, and I think we're a million happy children into it, and that should not be forgotten in your deliberations.

Thank you.

CHAIRMAN KASS:  Thank you very much.

Charles Queenan, Juvenile Diabetes Research Foundation.

MR. QUEENAN:  Good morning, Chairman Kass, and members of the President's Council on Bioethics.  Thank you for the opportunity to testify to you this morning.

My name is Charles J. Queenan, III.  I'm here today on behalf of my daughter Jenna, who is age 14 and suffers with juvenile diabetes, also on behalf of the million other Americans who suffer with juvenile or Type 1 diabetes, the Juvenile Diabetes Research Foundation International, and the Coalition for the Advancement of Medical Research.

Jenna was diagnosed with diabetes 11 years ago when she was only three years old.  Following her diagnosis, I very quickly became actively involved with JDRF.  I currently serve on the international board of JDRF and for the last two years I was the chair of the Research Committee for JDRF, and in that capacity was responsible for grants that during the last two years totaled over $200 million for diabetes research.

In addition, I have overseen the development of JDRF's embryonic stem cell research program.  JDRF has entered into stem cell research partnerships with three international governments.  We are also in discussions with another six international governments for such partnerships.

This year JDRF expects to commit over $10 million to stem cell research, ten million out of a total of 100 million research grant commitments, and JDRF is the only non-governmental organization represented on the United Kingdom sponsored international stem cell forum, which also includes representatives of 12 governments.

Much has changed over the last two years since the administration announced its policy for federal funding of embryonic stem cell research.  Stem cells continue to hold significant potential for a wide range of diseases and disorders that impact some 100 million Americans.  But it is clear that this area of science has not advanced as rapidly as it was envisioned when the federal policy was determined.

In our view it is time to consider expanding the availability of embryonic stem cell lines so that  millions of Americans can hopefully begin to see benefits from this research.

Let me provide you with an update on how embryonic stem cell research should impact juvenile diabetes.  JDRF is actively supporting embryonic stem cell research because we feel it holds enormous promise to play a critical role in understanding and curing juvenile diabetes.

Actually I should say it has promise to extend the cure for juvenile diabetes.  We are currently curing juvenile diabetes through transplantation of insulin producing cells, but we are currently helping only a very tiny percentage of those who have the disease.

Of the more than 250 individuals who have received these transplants, approximately 80 percent no longer require insulin injections to control their blood sugar.  To these men and women who were previously unable to control their blood sugar levels, even with multiple daily injections, this is, indeed, a cure.

Unfortunately, despite this unparalleled scientific progress that has been hailed as the biggest advance in diabetes research since the discovery of insulin, there's a severe shortage of insulin producing cells suitable for transplantation.  Only 2,000 cadaver pancreases are available annually from organ donors.  This means that the vast majority of the one to two million Americans with juvenile diabetes will never benefit from this therapy unless we can develop additional lines of insulin producing cells.

Embryonic stem cell research could play a key role in developing an unlimited supply of cells so that we might extend the cure for juvenile diabetes to all Americans who currently suffer from this devastating disease.

The current federal policy will never be sufficient to adequately  advance this promising field.  Just a fraction of the stem cell lines that were thought to have been available based on this policy can actually be used by a scientist, and even though stem cell lines might not safely be used for clinical trials because of the way they were derived.

We have worked closely with the White House, the Department of Health and Human Services, and the National Institutes of Health to try to implement the administration's stem cell policy.  However, research progress in this area to date has been frustratingly slow primarily because of the limited number of stem cell lines scientists have to work with.

The importance of having access to additional stem cell lines from excess in vitro fertilized eggs that would otherwise be discarded is crystal clear.  The time has come for a fresh look at the policy so that it can be revised in light of what we now know to more successfully move the research forward.

Take the following four examples.  First, the number of embryonic stem cell lines determined to be available under the President's plan was 78.  However, at present information about only 11 are on the NIH registry, and even fewer are fully available to researchers.

Second, most, if not all, of the embryonic stem cell lines on the NIH registry were developed using mouse feeder material as a nutrient.  We are very concerned that this could make these lines ineligible for use in human therapeutics because of the potential for cross-species contamination.

Third, while much concern has been expressed about the lack of genetic diversity in the limited number of embryonic stem cell lines that are currently on the registry, less attention has been paid to a related issue.  Scientists are finding that the various embryonic stem cell lines are proving to be much more heterogeneous than was previously thought, and specific lines are tending to differentiate to specific types of tissues.

This means that researcher access to additional stem cell lines will be even more important as we try to grow genetically diverse tissue specific therapeutics for a number of different diseases.

Finally, fewer than expected young scientists are entering this area of research.  Anecdotal evidence indicates that the reason for this, beyond the laundry list of practical considerations I have just discussed, is concern among young investigators entering a new field that there is a lack of long-term commitment by the federal government as evidenced by the present limited policy to provide a stable, creative, and nurturing environment for stem cell research.

Chairman Kass, I appreciate the Council's continued interest in embryonic stem cell policy.  JDRF shares the President's interest in advancing this field, and we look forward to working with you to develop new ideas and approaches to the current federal embryonic stem cell policy and to make the promise within this field of research a reality.

In conclusion, I just want to add that I understand that there is concern that some patient organizations may look upon this research with unrealistic and perhaps overly optimistic assessments of the difficulty in finding a cure, and I want to say for the record that in my experience both with other members of the JDRF board, thousands of volunteers both in JDRF and in other foundations, that really is not the case.

I think you would find that they are very well informed both about the scientific potential and the policy issues surrounding human research.  What we do want, however, is to avoid artificial barriers to moving forward the scientific research that must go forward.

Thank you very much.

CHAIRMAN KASS:  Thank you.

Kirsten Moore of the Reproductive Health Technologies Project.

Welcome.

MS. MOORE:  Thank you.  Thank you for this opportunity to present our comments.

My name is Kirsten Moore.  I'm president of the Reproductive Health Technologies Project.  We're a national, nonprofit advocacy organization, and our mission is to advance the ability of every woman of any age to achieve full reproductive freedom without access to the safest, most effective, appropriate and acceptable technologies for insurance her health and controlling her fertility.

We view technology not as an end in itself, but as an essential component for all women and men, including those who are underserved and historically been excluded to control their own health and fertility.  We believe each technology requires careful analysis of its safety, effectiveness, acceptability, appropriateness and ethical aspects, recognizing that these vary from person to person and community to community.

Almost two years ago we began a process of dialogue and education within the women's health community on the issue of stem cell nuclear transfer.  Over the past 18 months, we've invited experts, scientists, legal scholars, bioethicists, practitioners, and patient advocates to share their perspectives on the science policy and politics of SCNT to help inform the position of a number of organizations within the women's health and reproductive rights communities.

You will not be surprised to hear there is no uniform position on the use of SCNT for research or reproductive purposes among the many organizations and constituencies which make up this community.  At the same time there is a strong consensus among many groups that SCNT holds the potential to expand our knowledge of human physiology, and with that, to develop safe, effective treatments for a broad array of diseases and injuries.

The promise of such benefit from this research is significant, and to many organizations, including my own, the Society for Women's Health Research, the National Partnership for Women and Families, and the National Women's Law Center, justifies use of preimplantation embryos in such research.

At their request and with your permission I'd like to leave statements from the society and from the National Women's Law Center in this record.

Even with that consensus, there are varying opinions as to how such research should move forward.  Speaking from my own organization, we believe SCNT research holds potential for unintended consequences, as well as intended uses that may have adverse outcomes.

To maximize the benefits of this research and minimize the risk both to individuals and society at large, the Reproductive Health Technologies Project calls for policy proposals that will enhance and strengthen existing policy and regulatory guidelines which protect human subjects in research and insure that consumers can rely on the safety and efficacy of FDA approved products.

In establishing such federal or state oversight, we would like the following guiding principles to be observed, and I would like to point out that we ducked the question that you were dealing with earlier about exactly how to do this.  So these are just our thoughts, no agencies assigned.

The scientific rationale as well as the risks and benefits of proposed SCNT research are evaluated with public oversight and accountability.  The short and long-term safety and efficacy data on any therapies or procedures that use SCNT are made available to the general public on a timely basis and in an appropriate format.

Informed consent and confidentiality of all participants, including donors of genetic material who will not benefit directly from the research is ensured.

Adequate protections are established to minimize the potential that embryos created for use in SCNT research are used for the purposes of reproduction.  Payment for gametes and other genetic materials used in SCNT research which exceed the cost of participation are prohibited.

The same regulatory guidelines and enforcement mechanisms should apply to all SCNT research, whether or publicly or privately funded, and inappropriate activities are discontinued and violators subject to civil penalties.

Thank you.

CHAIRMAN KASS:  Thank you very much.

Before we break, let me make clear, as clear as I can, what the next steps are with the two things that we've talked about this morning.

At the break Carter Snead had to leave, but he and I spoke about the need to tap a number of you for some paragraphs on the topics on which you either eloquently spoke or we suspect you have some knowledge that would help.  You probably know who you are, but expect to hear some requests from us to help fill out some of those things on the monitoring and things talked about earlier.

With respect to the Beyond Therapy project, we'd like your written comments by the date indicated, and you should expect—we didn't quite finish additional materials to give you today, but you'll have them some time next week, the next two installments for your reading pleasure and critical comments having to do with the pursuit of less aging bodies and more happy souls.

Cheerful thoughts, good health.  Thank you for your attention and wonderful contributions.  Safe trip, and we'll see you in September.

(Whereupon, at 11:57 a.m., the meeting was concluded.)


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