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Meeting Transcript
April 1, 2004

Hyatt Regency Crystal City at
Ronald Reagan Washington National Airport
2799 Jefferson Davis Highway
Arlington, VA 22202

COUNCIL MEMBERS PRESENT

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

Benjamin S. Carson, Sr., M.D.
 Johns Hopkins Medical Institutions

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

Michael S. Gazzaniga, Ph.D.
 Dartmouth College

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

Alfonso Gómez-Lobo, Dr. phil.
Georgetown University

William B. Hurlbut, M.D.
Stanford University

Charles Krauthammer, M.D.
Syndicated Columnist

Peter A. Lawler, Ph.D.
 Berry College

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

Diana J. Schaub, Ph.D.
 Loyola College

James Q. Wilson, Ph.D.
Pepperdine University




INDEX


WELCOME AND ANNNOUNCEMENTS

CHAIRMAN KASS:  Would members please take their seats, so that we can begin?

Good morning.  Welcome, members of the Council, to this the 16th meeting of the President's Council on Bioethics, the first of our second term.

Welcome also to members of the public.  We're delighted to have you with us.

I would like first to recognize the presence of Dean Clancy, the Designated Federal Officer in whose presence this is a legal meeting.  Not everybody here will recognize Dean Clancy, who has, in honor of his forthcoming 40th birthday, emerged from hiding and shed his whiskers.

Dean, on behalf of all of us, a hearty congratulations.

(Laughter.)

I would also at this time like to introduce to the Council our three new members.  To my left, Dr. Ben Carson, who is Professor and Director of Pediatric Neurosurgery at Johns Hopkins Medical Institution; two to my right, Peter Lawler, who is the Chairman of the Department of Government and International Studies and the Dana Professor of Government at Berry College; and three to my left, Diana Schaub, who is Professor and Chairman of the Department of Political Science at Loyola College of Maryland.

Welcome to the three of you.  You've joined an interesting, sometimes contentious, but I would like to say civil and productive group.  We are very much looking forward to working with you over the coming months and year.

SESSION 1: BIOTECHNOLOGY AND PUBLIC POLICY: COUNCIL'S REPORT TO THE PRESIDENT

CHAIRMAN KASS: The main purpose of this first session on biotechnology and public policy is the release of the Council's report to the President, "Reproduction and Responsibility:  The Regulation of New Biotechnologies," copies of which members should have at their places.

The procedure for this session is as follows.  I will make some relatively lengthy remarks introducing the report and trying to summarize its contents and conclude with some statements of what I regard to be the report's major achievements and caveats.

Individual members who have expressed the wish to comment will then do so.  I think by my list we have either eight - we have either nine or 10 such people who want to say something briefly, two to three minutes. 

There are, I believe, some members of the public with whom we have consulted over the course of writing this report who have submitted personal statements, and some of them I think would like to read them, and then the floor will be open for comments and questions from the media.

Let me begin.  The report that we release today, "Reproduction and Responsibility:  The Regulation of New Biotechnologies," examines policy and regulatory issues that arise at the intersection of assisted reproductive technologies and genomic knowledge - an increasingly busy intersection and one that raises a daunting array of opportunities and dilemmas for patients suffering with infertility and for doctors and researchers.

It raises the prospect, but also certain kinds of risks, of new life for children born with these procedures.  And it has certain social implications important for regulators and policymakers and, indeed, for the American public as a whole.

The report is the product of a two-year process for us, which really began at the very first meeting of this Council in January 2002 when, you will recall, Frank Fukuyama expressed the hope that as one of its projects this Council might explore how new biotechnologies are regulated in the United States and perhaps recommend some ways that regulatory practices could be improved, given new technologies and the new sorts of challenges that they represent.

With time, and given the other projects in the last term of the Council, the term of which this report is, in fact, the final product, we put that focus of regulation on the more particular domain of assisted - of the issues that arise at the confluence of assisted reproductive technologies, genetic testing and selection, sex selection, and embryo research.

In the cloning report published in July of 2002, the Council stated frankly that further inquiry into the current state of regulation in this entire area was necessary.  And since that time we have, in fact, been taking this up.

We've devoted a very significant amount of our time to this project.  We've had 26 public sessions devoted to it.  We've had presentations from a great many experts and stakeholders, including patient groups, professional societies, government agencies, policy experts, and people who are involved in the regulation of these areas in other countries.

We put out a call for public comment and received valuable written comments from dozens of groups and individuals around the country, and in the report we list and acknowledge the help that we have received from all of these people, and we are very grateful to those present and those not present for your help.

The Council, with the help of the staff, produced this - took all of this in and produced the report that we have before us.  The bulk of this report is, in fact, a diagnostic document laying out the present state of regulation of these fields to the United States, public and private, governmental and professional, federal and state.  And it concludes with some modest interim recommendations for how a few outstanding problems might be dealt with in ways that we think should be agreeable to just about everyone involved.

We have not at this time recommended major institutional reform or major institutional innovations, because a great deal of what we have found in our review of this field is that much remains to be known.  We need more basic data regarding current practices and their impact to find out how big a problem this really is. 

We need to figure out the effectiveness of the rules and regulations that now exist, both governmental and professional, and we need to explore the costs - the benefits and the harms of any kind of new innovations that anybody would like to propose.

Before going on, I want to say - I want to say something about the staff work that has gone into this.  I mean, the members have contributed enormously, reading many, many drafts.  But the real credit for this report belongs to the staff, and especially to Carter Snead, our General Counsel, who has taken the lead on this project.

And let me say that this staff has put out five volumes, four reports and an anthology, in 26 months.  They are extraordinarily devoted to their work, top to bottom.  The morale in the office is extraordinarily high, because people like what they do.  They work well with one another.  They believe in what we've done. 

And I would like at this point simply to express my profound gratitude on behalf of all the members to the entire staff, top to bottom, for what you've done.  So thank you very much.

Before I get to the actual content of the report, we should point out that people who read the transcripts of our meetings and the discussions that produced this report will give you a sense of the fact that this Council has deep disagreements and differences. 

And if you read the recommendations in this report, you will discover that - which are made unanimously by this Council - you can see how people who nevertheless disagree profoundly on some issues can nevertheless find some common ground.  And I think this - as I will say at the end, I think this is really one of the great achievements of this report.

And I hope it offers an example to policymakers about the way in which, notwithstanding our continuing disagreements and arguments, we can find common ground and even seize it as we continue to debate those other things that don't lend themselves so easily.

I think most people are going to be interested, at least on this occasion, in the recommendations.  But before I get to that, let me give you a kind of overview, a guided tour to the whole document, so that you can have a sense of what's in the report.

The report is in three parts.  There's an introduction; Part 1 is the diagnostic survey, which is the bulk of the report; Part 2 explores policy options and concludes with recommendations.

The brief introduction lays out just why the Council has set out to explore this area and what we take to be some of the most important concerns and values that should guide anybody interested in exploring regulation - from the health and well-being of infertility patients and their children, to the desire to seek new therapies for the suffering and the sick, to the responsibility to protect and respect human life, and to a number of other critical issues of privacy, equity, freedom, and dignity.

The report is guided and motivated by all of these, and the introduction lays out these values at least in some beginning detail.

The great bulk of the document, to repeat, is devoted to a diagnosis of current regulatory practices in different areas having to do with the intersection of assisted reproduction and genetic knowledge.  Assisted reproduction is not, as such, our focus, though we have looked at how it is currently regulated in the course of our diagnosis, because assisted reproduction is, in practice, the necessary gateway to all of the newer technologies present and projected that will affect human reproduction.

Any oversight or regulation of the use of genetic technologies in human reproduction will, therefore, necessarily depend on the systems that oversee and regulate assisted reproduction itself.  Therefore, in Chapter 2, we begin by looking at the state of the art in assisted reproduction, laying out in general some relevant ethical issues that need to be addressed, and then examining in great detail the variety of ways in which the practice is regulated.

And by the way, "regulated" here is a very loosely used term.  I mean, it doesn't mean law and proscriptions.  It means anything that affects the practice by deliberate design, professional guidelines, and norms primarily preeminent amongst them.

This three-part approach - techniques and practices, some ethical questions, and exploration of existing regulation - is the model for how we examine the rest of the techniques that we take up in the diagnostic portion of the report. 

In Chapter 3, Genetic Screening and Selection; in Chapter 4, Modification of Traits and Characteristics, where it's important for me to point out that in this report, as the Council has done before, we point out that significant genetic modification of traits through genetic manipulation is simply not in the offing in the foreseeable future.

In Chapter 5, research on in vitro embryos; in Chapter 6, some issues of commerce that arise in the various fields and that carry their own regulatory challenges; in Chapter 7, we briefly conclude and summarize the diagnostic section.

All of this is brought together in the report's eighth chapter, which offers in a succinct and organized form the Council's findings in the light of the extensive diagnostic survey.  These findings you can find listed in the Executive Summary, Roman Numeral pages 43 to 44.

And I won't read them all here, but one of the things that we have discovered is that there really is a lack of basic data on the effects of assisted reproduction and associated technologies on the health and the well being of the women and the children involved.

The findings show that right now, although there are various kinds of regulatory practices in place, there is really no uniform comprehensive or enforceable system of data collection, monitoring, or oversight for the biotechnologies affecting human reproduction, and that there is minimum government involvement in the regulation of these technologies with the notable exception of gene transfer technologies, where regulation is really quite effective through the RAC and the NIH.

There is, however, fairly extensive professional self-regulation of some of these practices, even if compliance is voluntary.  We find that there are no uniform rules regarding access to assisted reproduction or insurance coverage, and with regard to the new technologies we find that experimental technologies that work move very quickly into general practice where their use becomes widespread pretty rapidly, though not necessarily with prospective studies to study their effects.

These are some of the findings that emerged from the Council's review of the field, and it's important to understand that none of them mean simply that some particular action is called for.  In some cases, what we have found is that the field does not differ from how things are really done in medicine in general, and in some cases we have not found that the present situation really calls for change.

In short, this preliminary review and diagnosis has not led the Council at this stage to make any sweeping suggestions for institutional reform or institutional change.  Nevertheless, we thought to at least advance the discussion, in the ninth chapter we set forth certain kinds of policy options that might be available, just to show the range of the options that exist, or that have been pursued elsewhere in the world or in other fields.

We lay these out to offer a sense of the range of what might be done rather than as examples of what we now think should be done.  And we make it quite clear that, given the preliminary character of this report and the fact that our review of the field has turned up a number of areas where crucial data are still lacking, the Council is not prepared to recommend sweeping institutional reform or innovation.

Instead, members have sought - in the interim while the conversation and discussion proceeds - we have tried to see whether we could agree on some modest measures to alleviate some clear and significant present problems, including especially the lack of information on certain key practices and their consequences.

And these measures are laid out in the chapter's tenth and final chapter, the recommendations chapter.  And in that chapter we offer interim measures that we believe should be adopted immediately, and these recommendations, I repeat, have been offered by the Council unanimously.

The strategy here in the recommendations chapter was let us set aside for the time being those things on which we disagree, and let us see whether we can in the interim, as modest temporary measures, make proposals that all of us could stand behind.

The recommendations fall into three categories, and for those who would like to follow, you can find these recommendations in the Executive Summary.  The defense of them is in Chapter 10, but if you want to see them succinctly they appear in Roman numerals 46 to 49 of the Executive Summary, in the front matter of the book.

Three categories of recommendations - the first are federal studies, data collection, reporting, and monitoring regarding the uses and effects of these technologies.  Here we are recommending federally funded studies to examine the impact of various assisted reproductive technologies on the health and development of children born with their aid and on women who undergo treatment.

We also recommend a few discrete steps to strengthen and augment the one existing piece of federal legislation - the Fertility Clinic Success Rate and Certification Act - the Act which provides information to people seeking fertility treatments.

These measures we recommend to help bring the law up to speed with new technologies that have developed since the law was enacted and to better protect consumers and patients.  They are very much in the spirit of the law that already exists on this subject, and these recommendations have been drafted with - in consultation with the professionals who work in the field.

Let me emphasize one item here that I think is of special interest.  This Council has taken special note of the importance of learning about the implications and effects of these technologies on the children who are born with their aid. 

There have been no longitudinal prospective studies of the children born as a result of assisted - with the help of assisted reproductive technologies - despite the fact that these practices have been flourishing since 1978.   There are lots of reasons for this.  We're not second-guessing the failure to do so.  There's questions of funding.  There's questions of privacy.  There are all sorts of matters.

But one of the reasons I think that there hasn't been this much attention is that the profession of - the reproductive endocrinologists - have, for perfectly obvious reasons, regarded the infertile couples and the adults as their primary patients.  When the pregnancy is achieved, the patients are turned over to the obstetricians, and it is only late in the day that the pediatricians get into the story.

One of the real important contributions, I think of this report, is to shine the light on the importance of attending to the children and learning much more about what this means for them now and in the future.

The second set of recommendations are addressed to the professional societies and the practitioners in the field of assisted reproduction.  There is a fair amount of regulation that is self-regulation in this area, as there is in medicine in general, but we have suggested a few ways in which that self-regulation might be improved for the benefit of all involved.

These include a strengthening of informed patient decisionmaking, improved enforcement of the societies' own existing guidelines, and suggests to them development of additional standards for human subject protection.  And these you could find on page 47.

The third category of recommendations, the ones that are likely to get the most public attention, consist of a few targeted legislative measures.  In the course of our review, the Council has observed the fast-moving pace of research and innovation in this field.  We have noticed that there are various kinds of values and goods connected with human reproduction that we hold dear and that we would like at least to protect.

And since we do not know whether or when or even - whether or when any kind of more formal regulatory or oversight mechanism would be developed in the future, we thought that since we are making this as an interim report we ought to think about whether there are interim measures that we could suggest that could at least set certain kinds of boundaries to protect things that we hold dear while the public deliberation goes on.

And we have decided that there are certain areas that need special attention, and we recommend in this report that Congress should consider some special targeted legislative moratorium. 

The report itself in Chapter 10 offers extensive discussion of the reasons for these recommendations and gives the reasons for - and it also discusses the aims that we think that these targeted measures should serve.  And these are found on pages 222 through 225, 227, of the report.

These recommendations are in order to help preserve a reasonable boundary between the human and the non-human, or between the human and the animal in human procreation, to preserve respect for women and human pregnancy, preventing certain exploitive and degrading practices, to show respect for children conceived with the aid of assisted reproductive technologies, securing for them the same rights and human attachments naturally available to children conceived in vivo, and to set some agreed-upon boundaries on how embryos may be used and treated notwithstanding the fact that we have lots of disagreement in this Council about the embryo question in its entirety.

Returning to the particulars, therefore, with respect to the first point, the Council calls for the prohibition of the transfer for any purpose of a human embryo to the body of any member of a non-human species for purposes of research to prohibit the formation of hybrid human-animal embryos by fertilization of human egg and human sperm.

Under the second category, that there should not be pregnancies initiated for any purpose other than to produce a live-born child.  That is to say, pregnancies are not for the purpose of experimentation or for harvesting body parts.

With respect to the child, we call for a proscription on conceiving a child by any means other than the union of egg and sperm, where conceiving a child is carefully defined to mean the creation of an embryo ex vivo with the intent of transferring it to a woman's body to begin a pregnancy.

I'll say something more about this, but it has been noted that one of the practices that this would include would be, of course, the cloning of an embryo with the intent to transfer it.  And so with respect to cloning, this recommendation is really a restatement in greater detail of an earlier Council position unanimously opposed to cloning for producing children.

The differences, of course, on the cloning for research remain, and I will allude to that further.  We have also called for a prohibition on conceiving a child using gametes obtained from fetuses or derived from embryonic stem cells, or by fusing blastomeres from two or more embryos.  No child should be able to say, "My mother or father is a fetus," "an embryo," or a "stem cell," or that "I come from fusions of two or more embryos."

On the embryo research question, notwithstanding our continued deep differences, we have called for setting a limit on the use of - a prohibition on the use of embryos in research past a certain stage in development - again, a position that many sides, as they presented testimony to us, said that would make sense.  And our approach here is also different from that proposed in other countries or proposed in Congress.

We not here call for research on embryos. We do not call for proscription of research on embryos.  We simply say that where research on embryos proceeds, it shall not proceed past a certain stage of development.

I think that really is the gist of the recommendations.  Let me say in summary what I think are the major accomplishments, and then I would invite members to offer their comments.

First, I think one of the great accomplishments of this report is that this really is the first comprehensive survey of current regulations in this area - what's going on, whose business is it to do what, and how, what are the gaps in what it is we would like someone to be paying attention to, what more do we need to know in order to intelligently advance this conversation.

Second, we've placed a highlight on the well-being of the women in these procedures, and especially on the children born with their aid.  And as the new technologies come to augment the existing practices, the attention to these matters can only increase, and it would be very important to try to beef up our - our monitoring and oversight of their well-being now.

Third, we have been sensible and moderate with respect to institutional reform.  This is but a first step down that road.  We have not leapt in with both feet before thinking through carefully the implications of doing something rather than nothing, and of doing this something rather than something else.

We're not shying away from that further conversation, but we are taking this slowly and carefully as we should.  Regulation has its costs, and they have to be assessed in the process.

Third, this is a very divided council on certain kinds of questions.  Once we get away from certain kinds of questions I have no idea how divided we are going to be, and I'm very much looking forward to the opportunity of moving into some areas where it's going to be impossible to predict what the various members around the table are going to say.  And that starts in session two this morning.

However, I think it was a wonderful idea in this project to say, "Look, let us search for common ground.  We disagree about much, but there's much more that we might agree about if we are willing, in fact, to look for it." 

And given the polarities and divisiveness in the nation, not only on our questions but on lots of other questions, and given the fact that this is a council that is Democrats and Republicans, liberals, conservatives, pro-choice, pro-life, pro-research, scientists, humanists, theologians, that we could show by example what could be done if one, in fact, chooses to seek for common ground is I think a very exciting development.  And I suspect that that will get a lot of attention.

People will snipe at us for not getting everything that they wanted out of this, but I think fair-minded people will see, "Look what these people have done when they, in fact, decided to look for the values that they can mutually endorse rather than the ones about which they disagree."

Next, although we have sought common ground and achieved some kind of unanimity - and let me not exaggerate the unanimity, because there are people here who are nervous about some things, and not wrongly.  If you tread in the area of legislation, even if we agree as reasonable people that these things make sense, when they're handed over to - to the legislative process, who knows who will jump on this with what kinds of additional things, and that's a concern.  And it's been voiced by people here, and I share it.

Nevertheless, the agreement that we've reached here is not a compromise.  I want that to be stressed.  These are principled agreements.   These are principled agreements on the recommendations in the tenth chapter.  Principled agreements - everybody is supporting these for their own principles, but remarkably for different principles.  People are on board with these recommendations, not for the same reasons but for very different reasons.  And that's I think also not surprising, but a very appropriate matter.

And the personal statements in this document - a great contribution - as were the personal statements in the cloning report, indicate the multiple and different reasons why - that members of the Council have for supporting these recommendations and for what it is that they think the report doesn't do sufficiently or what it thinks that it perhaps borders on too much.

But - so we have achieved unanimity not compromise, on principled grounds, different principled grounds - we haven't, in order to gain this unanimity, aimed at the lowest common denominator as other attempts to gain consensus would have done.  We haven't done anything earthshaking here.  This is modest, but this is a modest but significant first step in an area where there have not been first steps before.

No one has gotten everything that they want.  We've all gotten something I think that we care about.

Let me conclude by offering some kind of caveats, and this - these caveats are not addressed to members of the Council as much as they are addressed really to the members of the public, given the likelihood of misunderstanding because we are revisiting here, especially in the recommendations, certain things that the Council has, in fact, spoken about both in its cloning report and its monitoring stem cell report.

Certain incomplete and, therefore, possibly misleading news stories earlier this week written before the report's release - have given some people the impression that the Council's unanimity extends beyond what, in fact, it does extend to - namely, to the still contested matters of embryonic stem cell research, federal funding, and cloning for research.

This is not the case, and I think the public should understand this.  The personal statements in this report make it perfectly clear that we still have deep divisions in this Council about those matters, and that the conversation will continue. 

What we've tried to do in this report, to repeat, is to develop those concrete set of proposals that people on different sides of the embryo question can accept for their own principled reasons, but without foreclosing the crucial continuing argument which all of us I hope will continue to make.

Second, concretely on the way in which this recommendation relates to the cloning debate in Congress and how it relates to our own previous cloning report, because I don't want this to be misunderstood. 

When we moved again to recommend something that overlapped with previous recommendations, I wanted it to be perfectly clear that no one in this Council was going to be asked to repudiate a position that they had taken previously, nor was the Council as a whole going to repudiate its report on cloning.  We didn't revisit that to debate that question.

The proposal we are offering here is fundamentally different, therefore, from the two cloning bans that are now before Congress.  One of them would ban the creation of cloned embryos for any purpose whatsoever.  The other will endorse research cloning and prohibit the transfer of cloned embryos to initiate a pregnancy, thus mandating that all cloned embryos be destroyed at some point in the process.

This recommendation does neither of these things.  It neither prohibits the creation of cloned embryos, nor does it endorse the creation of cloned embryos for research.  On this question our report is silent.

It does not create a class of embryos that must be destroyed.  It does not prohibit the transfer of cloned embryos were they do exist.  It does not prohibit creating cloned embryos for research.  All it asks is that it creates - it prohibits the act of creating a cloned embryo with the intent to initiate a pregnancy.  That's all we're saying on that subject.

In the Council's - this is a clarification and a way forward on the Council's recommendation in the cloning report where you will recall we unanimously called for a ban on cloning to produce children, a report - a call we here clarify - to repeat and clarify.

On cloning for research, the majority then called for a moratorium.  The minority recommended that this practice should proceed with recommendation.  The Council has not, in this report, changed its mind on that report.

Second and last, I don't think that there should be misunderstanding about what the Council is saying in this report on things touching embryo research and stem cell research.  We have called here for a moratorium on the buying and selling and patenting of human embryos for any reason, and a moratorium on research that uses latter-stage human embryos once they have reached a certain stage of development.  We have left it to the Congress to settle that between 10 or 14 days.

Regarding embryo research in earlier stages, and federal funding of such research, those stages where embryonic stem cells are derived, the nation and the Council, alas, are still divided.  Some members continue to believe that all embryo research should be restricted or banned; other members believe that it should be encouraged, accelerated, and federally funded much more than it now is.

What we agree on is only what we've got here - namely, that research on embryos at a later stage is either wrong or imprudent, at least for the time being, and should be placed under a moratorium.  In calling for this prohibition for the time being, the Council neither endorses federal funding for embryo research nor opposes it, nor does it propose limitations on research conducted with the very early stage embryos. 

On those contested matters this report and this Council is still silent.  We are calling only for a restriction of the practice that everyone believes should, for the time being, be restricted.  I think with these important clarifications, because there is a great deal of danger of misunderstanding, lots of people on various sides hoping to make use of this, I think we should simply say we've agreed on certain things.  I'm delighted that we have.  I wish it was possible to agree on more, but the society is divided on those things.

We will take a respite from those arguments here in the Council, but that is where we stand.

I think that's both too much and too little, but that's all I would like to say on behalf of the report as a whole, and then placing my own particular emphasis on what I think are our achievements, and try to correct some likely misunderstandings that have already produced a flurry of phone calls to the office saying, "You did what?"

So there it is, and the floor is open for discussion.  Before I ask for individual members who have asked to make comments, are there any questions to me in terms of what I've just said?  Well, that's it.

Good.  Well, I have a list of people who have asked to make comments.  And, Frank, since you are the founding father of this venture, even if it hasn't produced quite the child yet in full maturity that you had hoped for, perhaps you would be willing to lead off.  Frank Fukuyama.

PROFESSOR FUKUYAMA:  All right.  Thank you very much, Leon.  I am in fact extremely happy with the publication of the Reproduction and Responsibility report.  I want to thank the staff of the Council for its assiduous, you know, pursuit of this issue.  And I think that the result, for all of the reasons that Leon just laid out, is something that we can all be quite proud of.  And let me also thank the other members of the Council for working together to agree on it.

I think that since it's a relatively short statement I'm simply - and since Professor Wilson has also signed on to this, I will simply read the personal statement that I have written, because I don't want to put words in Jim's mouth.

We believe that the Reproduction and Responsibility report is a very important document that articulates a broad, moral consensus over the limits that our society should place on new reproductive procedures that are now made possible by technology.  Proposed legislation, if passed, would ban certain clearly unacceptable techniques, including reproductive cloning, while at the same time neither prohibiting nor condoning research cloning or other forms of embryo research.

As such, it shows a way to get past the current deadlock that leaves the United States as one of the few developed countries without guidelines in this area, and I think that's an important point to stress.

Appropriate as these guidelines are, however, we believe that they represent only a first step towards a more complete regulatory approach needed to deal with these new technologies.  Today we can foresee possibilities like reproductive cloning or human-animal hybrids that should be banned, but the technology will move quickly and in the future pose ethical challenges as well as scientific and medical opportunities that we have not today imagined.

It would be difficult and inappropriate for Congress to intervene seriatim as these developments occur.  What is called for instead is a modernization of our existing regulatory structure to allow it to respond with flexibility in such cases, taking into account not simply the safety and efficacy of the new procedures but ethical concerns that would be widely shared in our society.

Our hope is that the current report will represent not a final word on the subject of the legislative limits but a beginning of a broader discussion of regulatory oversight of new reproductive technologies.  As a general rule, we do not welcome government intrusion into scientific inquiry and into the reproductive choices made by parents. 

But regulation frequently facilitates scientific advance and individual choice by reassuring the public that it is being done responsibly.  That is the light in which the current report should be seen as well as hope for future efforts to update and modernize our regulatory system.

Then, I would simply add in my own name.  I have been working independently through a study group to, you know, look at further measures.  I think at this point it is really not clear when you talk about the modernization of a regulatory system what that involves, whether you need actually new institutional powers, whether the existing institutions can actually be modified in one way or another to do that.

But I do think that we are at a juncture where we need to consider this further.  So I do hope that - that this, as I said in the statement, will not be the last word on this subject.  And I also would like to, again, stress the point that regulation is not in this instance an obstacle, I believe, to further scientific research. 

I think that as in the case of biomedical technology more generally, regulation is a - is something that actually promotes the possibility of future research by making sure that people understand that it is being, in fact, done safely and responsibly.  And I hope that people will take all of this in that light.

Thank you.

CHAIRMAN KASS:  Michael Gazzaniga?

DR. GAZZANIGA:  Well, there's going to be a certain redundancy to these messages.  And what I would like to offer here has already been said as part of the record.  It's not - it's my earlier thoughts on this enterprise, and so there are no surprises here that I have really never been happy with this effort since it was launched.  And the final report continues, really, to leave me unsatisfied.

While drafts of this report have been freely available for almost a year on the web, and while they have been updated and revised as we all know, and we have certainly extensively discussed these comments - all of this material at these meetings, I have never felt comfortable with the thrust.

This is despite the fact that a few of us, in addition to the time spent at these meetings, have spent many, many hours reading it, suggesting changes to its language, and yet I get the sense of - I was going to try some French here, but the more things change the more they stay the same.  But I never did well in French, so I won't give you the translation.

Somehow this report starts out examining the regulatory atmospheres of various reproductive technologies and concludes with a set of recommendations that really have a newsworthiness.  And, as Leon has just pointed out, on this cloning issue the objective stated time and again is to frame a set of recommendations that would break the logjam in Congress on the issue of cloning.

This is achieved in the present document by suggesting we outlaw any other means of making a baby except by the union of egg and sperm, whether it be through normal sexual activities or through IVF technologies.  At this point in human history, this is certainly fine with me.

The report also recommends any research use of leftover embryos from IVF has to be completed by 14 days, and that, too, is fine.  What is not said, however, and as Leon has alluded, so this is the redundancy here of the message and is left open, is whether or not federal funding can be used to study those leftover embryos, or clumps of cells as I would prefer to call them.  They would serve as a rich source, as we all know, for stem cell research. 

It is also not stated that somatic cell nuclear transfer procedures - so crucial for therapeutic cloning - could go forward with federal funding.  Sometimes I think we have the sort of cloning version here of the "Don't Ask, Don't Tell."  I say again, let's be explicit, and that's what my difference here is I'm drawing - is I think we should move forward to being explicit on these important issues.

And, finally, this Council has been through the issue before - these issues before, as you all know.  The one time we did vote on anything in the Council, in 2002, the majority of us voted - 10 to seven - to reject an outright ban on biomedical cloning.  Ten of us had no ethical objections in principle to biomedical cloning.  Of that majority, three major - three members wanted to, nonetheless, have a moratorium until regulations were in place.

I now think we are moving towards having those recommendations in place, and I hope and assume that these Councilors will soon be ready to move forward and support federal funding of biomedical cloning.

Thank you.

CHAIRMAN KASS:  Thank you very much, Mike.

I have Alfonso Gómez-Lobo next, please.

DR. GÓMEZ-LOBO:  Thank you.  Now, the specific reasons I had to endorse the report are really spelled out in the two additional statements to which I added my signature, so I won't repeat those.

Now, what I'd like to do in this very brief statement is, on the one hand, again call attention to the cultural and deep background against which we are addressing these things, and then I'll move to the specific recommendations. 

In my view - and I feel very strongly that because of my professional background I may be called to insist on this in this Council - from my perspective, I view our culture as moving at a swift pace towards the radical instrumentalization and exploitation of early human life. 

We're going by incremental steps, and early human life I think is, of course, an expression that refers to human beings who find themselves at a stage at which we all found ourselves at the beginning of our own lives.  We all started as a one-celled organism and grew to be what we are today - namely, the same organism but with millions of cells.  And I am, of course, always willing to rediscuss the question of identity through time.

But one of the consequences of that is that if we deserve protection today, we deserved equal protection then.  Of course, I could expand this argument for hours. 

However, in my view, going now to the recommendations, the document we are unveiling today is a minimalist document.  The recommendations in the closing section of the report should be understood, in my view, as minimal protections, as the least we should do. 

It seems to me that the transfer of a human embryo into the body of a member of a non-human species, the production of a human-animal hybrid, if it works, the buying and selling of human embryos, the patenting of whole human organisms, are all activities that reasonable people should reject as basic violations of our dignity.  That is, as forms of instrumentalization.  I think that's basically what dignity means here.

The report also seeks minimally to restrict destructive or harmful experimentation after a certain period in the life of an embryo, because at present those legal restrictions simply do not exist.  We make no recommendation, however - and Leon has insisted on this - on what should be permissible or impermissible during the first few days of life, nor is there any recommendation with regard to federal funding.

In fact, I join many Americans in thinking that destructive or harmful experimentation on human embryos, either produced by cloning or by union of the gametes, should be prohibited altogether.  The Dickey Amendment, of course, is I think, again, the minimal we could do.

If enacted, the recommendations of this report would raise a very basic fence in front of activities that are, I think, deeply dehumanizing, and I'm glad we could all agree on them.

Thank you.

CHAIRMAN KASS:  Thank you very much.

Rebecca?  Rebecca Dresser.

PROFESSOR DRESSER:  This report responds to a significant information gap.  More information is needed on ART outcomes.  Few people would argue against the position that novel ART interventions should be evaluated according to the criteria used to evaluate other novel biomedical interventions, and that is safety and efficacy.

Yet a combination of circumstances has produced relatively weak oversight for ART.  Because the NIH and other federal agencies rarely support research relevant to ART, innovative approaches may be tried in patients without prior scientific or research ethics review.

Because novel ART procedures are ordinarily not subject to the FDA approval process that governs drugs and other medical products, ART procedures may be offered and performed without meeting the agency's safety and efficacy standards.  Because insurance coverage for ART is limited, insurance company demands for properly qualified practitioners and adequate facilities have less impact on the quality of care than they do in other medical areas.  And because causation, negligence, and harm can be difficult to detect, much less to prove, the tort system is ineffective in deterring substandard practice. 

Now, the profession I think has made an important and significant effort to assess its methods and encourage ethical practice by clinicians, but more is needed.  There is a professional medical duty to make reasonable efforts to discover risks associated with interventions that are offered to patients.

Fulfilling this duty is also in the profession's self-interest, for careful evaluation of ART interventions will lessen clinicians' exposure to liability for any alleged harm related to the interventions. 

And there is also a broader social interest in learning more about the effects of ART - for example, in learning more about the possible health effects in children born after the use of these interventions, and in learning more about the health of the women undergoing superovulation, either as part of their own treatment or to provide oocytes to others.

Now, if researchers are going to increasingly seek human oocytes for research purposes, such as to create embryos through cloning or IVF to serve as sources of embryonic stem cells, more women are going to be exposed to these high doses of hormones and to other parts of the oocyte retrieval procedure.

We really need to find out whether there are any long-term consequences of oocyte retrieval.  At minimum, we ought to have solid information about risks to give to women who are thinking about undergoing this procedure.  And at a broader level, we should have this information when decisions are made about whether the potential knowledge gains generated through creating research embryos would justify the harms it could produce.

Finally, the legislative recommendations the Council endorses in this report are narrow and are designed to shift the burden to those proposing certain questionable practices.  These recommendations seek to change the U.S. status quo from one in which individuals seeking to engage in such practices have no obligation to explain or give reasons for proceeding, to one in which such individuals would be required to make their case - that is, to give reasons that a substantial portion of the community would accept as justifications for going forward.

This kind of a shift would place the United States with many other developed nations engaged in ART and embryo research where researchers and infertility specialists proposing novel investigations or procedures must establish an appropriate basis for doing so. 

Our constitution establishes a very general framework for decisions about reproduction and research, but leaves most of the issues discussed in this report to be resolved through the democratic process.  People dissatisfied with the present U.S. situation, whether they are dissatisfied with the absence of constraints on embryo research and ART practice in the private sector, or dissatisfied with the absence of federal support for research involving embryos, or dissatisfied with the lack of attention to potential social effects of increased control over children born through ART - all of these people face a choice.

Those who insist on securing every change they desire will reduce the chance of securing any change.  A more fruitful alternative is to sit down with those who see things differently and to try to craft policies reflecting points of agreement.

In developing this report, the Council chose the second path.  I hope those considering our recommendations will choose this path as well.

Thank you.

CHAIRMAN KASS:  Thank you, Rebecca.

Gil Meilaender?

PROFESSOR MEILAENDER:  To gestate and give birth to this report has been for us considerable labor.  It is, I believe, a small beginning at thinking about some very difficult topics, difficult morally but also difficult in terms of the everyday life of many people.

Biotechnologies touching the beginnings of human life have, for the most part, simply grown up around us.  Not without thought, to be sure, but largely without the kind of thought that gives direction and sets limits.

It is not hard to praise their benefits, and it is not hard to bemoan their effects on our understanding of parenthood and childhood.  But it is very hard to say what, if anything, we ought to do or might be able to agree to do, given the circumstances in which we now find ourselves.

This report at least gives us a developed context in which to think about such questions.  It makes clear our need for further information, though I'm not confident that the information for which we call will provide all we need to know, in particular sufficient information about the condition of children born with the aid of IVF or detailed information about the numbers of embryos produced for our reproductive purposes but never brought to live birth.  So this is a very modest beginning.

The report does, however, move beyond calls for information and conclude with some recommendations for interim legislation, recommendations on which we have been able to reach consensus despite our disagreements on a variety of related issues.

The problem with consensus, of course, is that it can often be too cute by far, blurring rather than clarifying important disagreements.  And that will certainly be the case if we do not keep faith with each other about the nature of the agreement we have actually achieved.

It may be useful, therefore, simply to note for the record where these interim legislative recommendations leave us, what we have said, and where we have been silent.  With respect to cloned embryos, the Council here says nothing that goes beyond or qualifies what we said in our report "Human Cloning and Human Dignity."

Hence, the majority recommendation of that report, coupling together a ban on cloning to produce children with a four-year moratorium on cloning for biomedical research, has not been altered in any way and remains our majority recommendation for legislation.  We have not uncoupled those two forms of cloning or recommended uncoupling them.

With respect to the use in research of so-called spare IVF embryos, the Council has been able to agree only that there should be a point in the life of an embryo at which such research should be prohibited.  We have not endorsed research prior to that point in an embryo's life. 

We have certainly not recommended government support for research on human embryos at any point in their life, nor do our recommendations in any way suggest that the current prohibition on federal funding of all research that destroys embryos should be changed.

We have not recommended a prohibition upon the implantation of any embryo, and we have not said anything at all about what should be done with embryos at the point where research must stop. 

In the context of all those silences, we have said only this:  recognizing that there is research not governed by the restrictions on federally funded research, we have simply recommended that if anyone carries out research on living human embryos there be a point at which such research must stop.

Thus, the silences surrounding our agreements are very large and complex.  And lest good faith be replaced by duplicity and mistrust, I hope their complexity and their largeness will be both appreciated and honored by all of us.

Thank you.

CHAIRMAN KASS:  Thank you.

Michael Sandel.

PROFESSOR SANDEL:  Thank you.  Much of this report concerns fertility clinics.  But as the comments around the table have already made clear, the two elephants in the living room are cloning and stem cell research.  A great merit of the regulations in the report is that they point to a possible solution to the vexed issues of cloning and stem cell research that could overcome the current impasse in the United States Senate.

First on cloning. Despite the widespread opposition to reproductive cloning, the Senate hasn't been able to ban it because of disagreement about cloning for biomedical research.  This report offers an ingenious way of detaching those two questions.  It proposes that Congress prohibit attempts to conceive a child by any means other than the union of egg and sperm.

This language provides a way for Congress to ban reproductive cloning while agreeing to disagree on the question of cloning for biomedical research.  Congress could prohibit attempts to create cloned children while allowing debate to continue about cloning for stem cell research and regenerative medicine.

The proposed regulations taken together also point toward a possible compromise on federal funding of stem cell research.  They do so by addressing at least one of the main worries people have about stem cell research, which is the slippery slope worry.  This is the worry that without clear limits, embryo research could lead down a slippery slope of exploitation and abuse.

If we allow stem cells - stem cell research today, the argument goes, tomorrow some people might try to transfer embryos into a woman's uterus, or even a pig's uterus as we've heard said, to grow organs for transplant, creating the nightmare prospect of embryo farms, fetuses exploited for spare parts, and the commercialization of human life.

The regulations contained in this report address that slippery slope argument.  They do so by assuring that such research is done responsibly, within carefully prescribed limits.  No embryos used for research could be used or preserved beyond a 10- or 14-day limit, or transferred into a woman's uterus or into an animal's body to grow organs for harvest, nor could embryos be bought and sold.

By assuring that stem cell research is conducted within these limits, these regulations address the slippery slope objection, the worry about exploitation and abuse.  And so they point the way, or so it seems to me, toward a compromise on federal funding along the lines that were proposed back in July of 2001 by Senator Bill Frist. 

Senator Frist argued then that both embryonic and adult stem cell research should be federally funded, but within a carefully regulated framework, and these regulations begin at least to create such a framework. 

Now, why is this important?  Well, recent scientific developments illustrate the need to adjust federal funding policy along the lines that Senator Frist proposed.  Only 17 cell lines are currently available on the NIH registry for federally funded research. 

Just a few weeks ago, Harvard Biologist Douglas Melton announced the creation of 17 new embryonic stem cell lines that he is making available free of charge to scientists for non-commercial research purposes.  The Harvard stem cell lines meet all of the criteria proposed by Senator Frist. 

They were derived using private funds from blastocysts left over from IVF clinics, not from -  nothing involved with cloning - blastocysts left over that would otherwise be discarded and with the consent of the donors.  They meet all of the requirements.

And yet, under current federal policy, research on these cell lines is ineligible for federal funding.  Despite meeting all other ethical and legal requirements, these new cell lines were derived after 9:00 p.m. on August 9, 2001.  That's the only difference between them and the approved lines.

Now, the August 9th cutoff may have been a reasonable compromise two and a half years ago when it was thought that some 60 or 70 cell lines would be available.  But in the light of what we know now, that August 9th cutoff looks less and less sustainable, both practically and ethically, because whatever one's view of the moral status of the embryo it is difficult to understand the moral distinction between research on stem cell lines created before 9:00 p.m. on August 9, 2001, and research on stem cell lines created according to all of the same ethical requirements except for the fact that they were created later.

And so I endorse the regulations proposed in this report in the hope that they can point the way to a national compromise on both cloning and on federal funding of stem cell research - a compromise that will enable this country to promote the promise of stem cell research while upholding the highest ethical standards.

CHAIRMAN KASS:  Thank you, Michael.

I have just two more people, so that people know where we're going.  I have Robbie George and Dan Foster.

PROFESSOR GEORGE:  Thank you.  I wish to begin by associating myself with the careful exposition of the content of our report this morning that was provided by Dr. Kass.  And also, I wish to thank him for the careful clarifications which I hope will help to prevent misunderstanding of the report, some of which is already abroad.

I'd like to direct my comments this morning not so much to my friends and colleagues on the Council, but broadly to citizens who are following our deliberations, and particularly to those citizens who share my own basic perspective on the fundamental ethical questions having to do with embryo research.

So I ask:  how ought the targeted measures proposed in Chapter 10 of the report we released today be regarded by members of Congress and by citizens who share the belief that human beings in every stage and condition, including the fetal and embryonic stages, are entitled as a matter of strict justice to full respect and legal protection?

I hope that they will be regarded as, in Dr. Kass' apt words, significant, yet modest, steps forward.  Of course they will be regarded, and in my opinion should be regarded, as not enough, for even if all of our recommendations were enacted into law injustices would remain in my view.

The moral ideal and the ultimate political goal must be full legal protection for all living members of the species homo sapiens, all human beings, irrespective of age or size or stage of development or condition of dependency or location.  It should never be lawful to treat a human being as a mere property or as disposable research material or as a collection of cells or tissues or organs to be harvested for the benefit of others.

As Professor Gómez-Lobo and I say in our statement attached to today's report, biomedical science should move forward aggressively by all ethically legitimate means in its mission of curing diseases and ameliorating suffering, but also adding to the sum of human knowledge.  Respect for human dignity requires nothing less than this.

But the very same principle of respect for human dignity also requires strict adherence to ethical norms protecting the moral equality and inviolability of each human being.  It is my hope that our law and public policy will move steadily in the direction of full respect for human dignity and protection for human life in all stages and conditions.

The targeted measures proposed in Chapter 10 should be supported, I believe, because they move us in the right direction.  They do not weaken or diminish any protection of nascent human life currently in place.  They do not alter the prohibition, for example, of federal funding for destructive embryo experimentation and research.

Their sole legal effect would be the desirable one of restricting unethical practices which are currently unrestricted by federal law, including some that are unfortunately encouraged by some state legislation. 

Today's recommendations are being proposed unanimously by our Council.  Although for some of us they are worthy of support as important steps in the right direction, for others they represent all or most of what should be done by way of restricting research involving the destruction of nascent human life.  As Chairman Kass has indicated, we remain divided on these basic moral questions.

We remain divided as a Council on the question whether all embryo destructive research should be forbidden.  We remain divided on whether cloning to create embryos for research should be permitted or proscribed.  Today's report leaves unaltered our recommendation on that issue contained in the Council's report entitled "Human Cloning and Human Dignity."

But these continuing divisions should not obscure the considerable consensus we have reached.  Even members favoring embryo research agree that even privately funded research should be subject to significant federal restrictions.

Even those who support research involving the destruction of human embryos in the blastocyst stage agree that after a certain point in development - 10 to 14 days or fewer - the use of embryos for research involving their destruction should be banned.

Moreover, in an important preemptive strike against the emergence of fetus farming for transplantable tissues and organs, the Council is united in recommending a ban on transferring a human embryo into the body of a member of a non-human species for any purpose or into a woman's uterus for any purpose other than attempting to produce a live-born child.

I know that many of my fellow citizens of New Jersey, alarmed by legislative developments in our state, will applaud the President's Council on Bioethics for its moral leadership in making these particular recommendations.  On the other hand, it is already clear that two of our recommendations are being received with caution and concern by citizens who believe in the full dignity of human beings at every stage of development, including the embryonic stage.

The first of these is the proposed day limit on privately funded embryo destructive research.  Some people fear that this will be perceived as an authorization of embryo destructive research prior to the limit. 

I would respectfully ask those who share this view, this concern, to consider the points advanced by Professor Gómez-Lobo and myself in our statement attached to today's report, as well as those developed in the statement in which we are joined by Professors Meilaender, Glendon, and Hurlbut.

The second point of concern has to do with the operational definition of the proposed ban on attempts to conceive a child by any means other than the union of sperm and egg.  On this point, the Council has attempted to find a way to preempt development of industries that would produce children who would be deprived of the rights and human attachments naturally available to children conceived in vivo.

A substantial body of opinion on the Council, and which I share, believes that the right way to proceed here is to ban the creation of such embryos by certain processes. 

For now, however, this does not appear to be feasible politically.  So our goal has been to design an approach that would provide an effective deterrent in the face of disagreement to the development of an unethical industry while at the same time avoiding any suggestion of legally mandated embryo destruction or placing limits on bona fide embryo rescue.

It's also important to note that we leave untouched the Council's recommendation of a four-year moratorium on the production of embryos by cloning for biomedical research, during which time those of us favoring a permanent and complete ban on human cloning would continue vigorously to make the case for such a ban to state and federal legislators and to our fellow citizens.

Whether our proposal on this particular point is a prudent way to proceed is a legitimate question that should be reflected on and carefully discussed by people who share the goal of protecting human life in all stages and conditions.  People who share the foundational ethical conviction may differ in the matter of prudential judgment, yet careful thought and discussion may yet yield consensus.

So to those who have concerns on this point, I would respectfully say that we should embrace those recommendations made by the Council today, which all of us can see advance the goal of respect for the life and dignity of the human person, while resolving to work together in carefully thinking through the matters on which differences of prudential judgment persist.

Thank you.

CHAIRMAN KASS:  Thank you very much.

Dan Foster, last but by no means least.

DR. FOSTER:  Well, you'd better not say that yet.  So anyway, I want to make a real-world comment, sort of in response to Leon's earlier explanations, and not comment on the report itself.  I thought the statements were very good.

One of the characteristics of the Council in its first two years has been open discussion, so that there has always been a transparency to the thoughts of the members, and that was one of its - has been one of its great strengths.  And in that spirit, I want to acknowledge a transparent fact briefly and without polemic.

And that fact is this:  that the reconstitution of the Council has evoked strong concern externally, especially amongst the scientific community.  The concern is that the Council has become unbalanced.  Two strong members of those who hold science to be a high good have left and have not been replaced.

Consequent to that, some members of the Council itself have been concerned and have conveyed that to Leon - this issue of the perceived imbalance that I have mentioned.  And I thought it would just be crazy to have a meeting here and not acknowledge that rea-world fact.

My colleagues would say, "What is this with all of this going on that there's no comment about the reconstitution?"  And that's the purpose of my statement here.

I want to point out that the concerned Council members are all here.  And, further, I think it fair to say that they think that the Council has been a good thing, and has done good work, despite the disagreements.

Now, three quick comments, and I'm through, about how to deal with this.  First, the Chairman has always been fair in letting issues be amply discussed in meetings.  He frowns a lot, but he has allowed ample discussion to take place.

Second - and this is to many of our scientific colleagues who felt that those - that we should not stay on the Council.  I can tell you that there are many, many of the major scientists in the United States who felt that the reconstitution was such that we should not serve. 

But my view is that it's almost certainly better to have the voice for science present in future discussions than absent, even though we're smaller in number.  And that's because science and scientific medicine is a very high good, and most of the people in this country know that.  So it's good, I think, to those who say "leave" that we stay.

And, third, there is always the possibility that rationality will conquer and that Leon and the older members on the "other side" will change their view.  And I certainly assume that as we welcome the new members to the Council we will do everything we can to make them become more rational, too.

(Laughter.)

CHAIRMAN KASS:  Charles?

DR. KRAUTHAMMER:  I just wanted to make a - I have no statement to make about the report, but I have been provoked by Daniel, as I have been in the past many times.

DR. FOSTER:  Charles, I've been provoking you ever since I joined this Council.

DR. KRAUTHAMMER:  Well, it finally worked.

I respect what you say, and I understand the sincerity and depth from which it comes.  But you talked about perceived imbalance.  We've heard about that perceived imbalance for two years now, including the Council as composed in the past, which we are now idealizing, and which when the Council began two years ago was characterized in the press and elsewhere as analogous to the Taliban, among others.  So let's remember where we started from.

I think anybody either reading this report, anybody hearing our discussion this morning, would say that the idea of perceived imbalance is only a perception.  We have just heard from Michael Gazzaniga a reference to the embryo as a clump of cells.  We have heard it referred to by Robbie George as the - deserving the dignity afforded a full human being.

We have the full range of philosophical approaches on this Commission, and I think it reflects very much the divisions and disagreements in society itself.  I believe this Council is the most diverse, open, and reflective of any bioethics council ever constituted in this country. 

And I think the fact that we produced a report today where we achieved unanimity despite our differences is a tribute, a) to the sincerity and the willingness of us to work together on common goals, and b) to the fact that in a diverse society we can actually have ultimate agreement on basic goods.

So I understand how there is a perception about a lack of diversity, but I don't think anybody with a fair mind, hearing what we have heard today, reading our report, could conclude anything except the opposite.

CHAIRMAN KASS:  Thank you very much.

Thanks to all Council members.  And, Dan, let me single you out.  Thank you very much for that comment.  I think it is good that the concern of the larger community is acknowledged here, and we will continue to strive in every way possible to make sure that every respectable opinion is heard, welcomed, and given the full weight that it deserves.

And on the question of being able to listen to reason, the conversation is always open, and persuasion is the ultimate possibility, and we look forward as we move forward to new topics to learn from one another and try to reach greater clarity, either about what we can't agree on, but certainly to try to find common ground as we proceed.

We have run over.  I'm long-winded.  Council members are wonderfully articulate.  Let me say the following.  We want to have at least - without stealing too much time for the next session - we have a couple of people - we have five sort of personal statements, four or five.

There are two who have asked to speak, people who have worked very closely with us in preparing this report.  Pam Madsen from the American Infertility Association, the Executive Director there, and Erin Kramer, who is the Director of Government Affairs from Resolve, would like to offer a comment at this time.

Then, we're going to have to take at least a few questions from the press for maybe five minutes.  The rest of them we can deal with at the break.  But let's at least have these comments.  I will call attention to the other press releases that we have, so that people can read them, and I won't take up valuable time here.

Ms. Madsen, would you please come forward?  And welcome back to our gathering.  It's nice to see you.

MS. MADSEN:  I do have a prepared statement that is out front, but I've actually chosen not to read from it, because if you want to read that you can read it.

First of all, I stand before you as probably one of the most recognizable faces and voices of the infertile community, as I have been doing this work for 15 years, and I was an infertile person.  I'm now a mother of ART children.

I want to first begin and thank you all for listening, listening to the stakeholders that have come to you.  I want to thank you for responding to us, because the responses - and, yes, there obviously has been division, and there has been division even when I've been thanking you.  I've been told maybe I shouldn't thank you.  So division has always been quite present.  But your staff and your chairman and all of you have worked very, very hard to be attentive and responsive listeners. 

And on behalf of the community that I represent, I do think we feel responded to.  Many things that we were extremely unhappy with are no longer in the report, and we thank you for that.  There are wonderful things as well that we support, that we do think is going to help the patient community - the women, the husbands.  You know, we don't talk about the husbands around this table.  It's always about the woman.

But there's actually usually two people who go in for treatment.  It's the man and the woman, and then there's the resulting children.  So for the protections for the couple and our children, we support any help that you can give us to get funding for prospective, balanced studies for the health and welfare of our kids.  And nobody cares more about that than patient organizations, because we are the mothers and the fathers of our children. 

As many of you know, the American Infertility Association, in partnership with Randt, is working to get funding for Footprints, which will be the first prospective IVF study in children in this country.  And it will be run by stakeholders, not by people with political agendas.  All we care about is an honest outcome, because we care about our kids.

We care about you supporting funding to help the women who are taking known and unknown risks for the dream of a child.  We want to know what we will face later in life, and very well nothing.  Maybe something.  But do we really know?  No, we don't.  So thank you for supporting that.

We thank you for preserving the rights of the individual to pursue collaborative reproduction without government interference.  We thank you for listening to us.  We thank you - I have to acknowledge Carter Snead, who has been a great ear to bring things to the Council for us.  We said, "How come you're not talking about insurance?"  And in this final report we see mention of the importance of insurance.

And we agree with your recommendation for publicly reported data to include the cost of ARTs to patients, as well as a number of ART patients, in addition to the number of cycles.  We feel that this is very critical information that all patients should have.

Do we have some issues with the report?  Everybody has issues.  Everybody comes to the table with different viewpoints.  And, yes, we too have some issues and anxieties, as Dr. Kass mentioned I think in the very beginning.

We have some issues with what we consider ambiguous language in some of the recommendations, such as the union of egg and sperm and creating a child.  Well, does that mean we can't do ooplasm transfer or cytoplasm transfer?  What does that mean?

I've been assured by the Council that it doesn't mean that, but this is a political document.  It's going to travel up.  Are you going to be there to explain exactly what it means to members of Congress?  I think you need - this is a pre-publication report.  There's a possibility for clarity of language.  It would help everybody interpreting your report to have a bit more clarity around some of these recommendations.

Thank you for inviting me repeatedly.  Thank you for listening.  Thank you for responding.  And I bet that you will respond yet again.

CHAIRMAN KASS:  Thank you very much, Ms. Madson.

Erin Kramer, please.  Welcome back.

MS. KRAMER:  Thank you so much.  We also at Resolve, the National Infertility Association, would very much like to acknowledge the time and effort of the Council members, the chairman, who has spent a great deal of time trying to be responsive to the various occasions when we've expressed concern about elements of earlier drafts, as well as the staff.

We think that there has been a great effort in at least being responsive and trying to be clear about what is the Council's intent in different versions.  And we want to acknowledge that you responded to our concerns about what we originally have thought were very overly burdensome proposed regulations of pro-pregnancy treatments.  Again, that's what we're talking about here is pro-pregnancy treatments for these couples.

We do, however, remain concerned about some aspects of the final report.  You know, the stated intent is consumer protections.  Yes, we know that.  But we feel that it may also make these medical treatments for the infertility of infertile couples more costly and less successful.  We think that's going to be the reality.

And we are wary of proposed governmental monitoring and publication of all aspects of fertility treatments to a degree that we still think is unheard of in other areas of medicine.

Our challenge, of course, is the next steps.  Our challenge is seeing this as it moves forward.  And we are going to make sure that if and when these recommendations are acted upon, they are implemented in a manner that is fair, is unambiguous, and is in the best interest of the millions of U.S. patients and their children.

We are going to remain vigilant to ensure that any further application of these recommendations does not limit access to medically necessary infertility treatments, does not unduly restrict the privacy of the people working so hard to build their families, and also the privacy of their reproductive choices.

We do applaud the Council for removing earlier recommendations and language that we thought was very hostile to ART, and that we thought in the end would be damaging to those seeking medical assistance to build their family. 

And we also recognize the Council for pointing out the important need for federal funding for the studies of assisted recommendation and also for including language in the final document that speaks to the issue of insurance, although we still feel that we will continue in our efforts for what we do think is the most important consumer protection, and that is procuring insurance coverage for those individuals working to build their family.

Thank you.

CHAIRMAN KASS:  Thank you very much.

Let me make an administrative decision.  We have a distinguished guest who is - we have already held - we have run 15 minutes over our time.  There are - I would be remiss if I didn't simply mention that we have a press release from the American Society of Reproductive Medicine and the Society for Assisted Reproductive Technologies.  They have released a statement.  This statement is available on the press table.

I was going to read it, but I will not do so.  They've been wonderful to work with, and we've learned a lot from them, and we will continue to work with them as we will with the patient groups.

We have a joint statement from the group Our Bodies Ourselves jointly issued with the Center for Genetics in Society, Judy Norsigian - and I've just lost page 2 - and Marcy Darnovsky.  This statement is out there, and they are willing to be called about this report.

And we have a statement from John Kilner from the Center for - President for the Center of Bioethics and Human Dignity, and a statement from Lori Andrews who has been one of our consultants.  I will not read these.  These are available to people who would like them.

In the interest of not spoiling the rest of the day, let me simply say I will stay here through the break and be available for questions from the press.  Members of the media may also, of course, speak to other members of the Council.

Let us take a break, and let us reconvene here at a quarter of 11:00, so we can hear Dr. Jessell's presentation.

Apologies to those members of the press who wanted the microphone, but I think we can try to help you get your stories written if you speak to us individually.  And I'll simply stay here.

This session is adjourned.  We'll convene in 12 minutes.

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

 

SESSION 2: NEUROSCIENCE, BRAIN, AND BEHAVIOR I: BRAIN DEVELOPMENT IN CHILDREN

CHAIRMAN KASS:  Session 2 of our meeting, Neuroscience, Brain, and Behavior I: Brain Development in Children.  From reproduction and the beginning of bodily life to the brain and the functions and flourishing of mental and emotional life.  Everyone senses the great excitement of neuroscience and modern psychology, methodical investigations by the mind of the mind to increase the human understanding of the human, prospects for addressing mental illness and aberrant behavior, and improving our abilities to make the most of our native mental capacities.  Everyone also vaguely senses that those exciting new discoveries might be accompanied by new ethical, social, and philosophical challenges precisely because these studies touch so directly on many of the powers and activities that make us who we are: awareness, memory, imagination, desire, motivation, thought, feeling, and moral judgment itself.

The Council is interested in learning about the developments in neuroscience and psychology present and projected that might raise significant ethical and social issues either because of the technological interventions to which they might lead, or because of changes in human self-understanding that they might invite.  In our Beyond Therapy report, we explored some of the psychotropic drugs that alter behavior, memory, and mood, in the service of goals beyond therapy.  But we sense that this was just one of a number of challenging issues that might emerge from this field.  At the last meeting we got a beginning in this area with introductory presentations from Robert Michaels on neuropsychiatry, by Jonathan Cohen on brain imaging and reward and decision, and you'll recall that we decided at that meeting before proceeding further to find out which aspects of this large domain were most worthy of our attention, that we should try to learn something about just the foundations, about normal brain and mental development, especially in children.  So today and the rest of today is about those foundations, the scientific foundations of normal brain and mental development in infants and in children.

The questions behind these discussions are really these.  What can neuroscience and developmental psychology tell us, either now or soon, that might be relevant for understanding how best to raise flourishing children and adults?  What can neuroscience and developmental psychology tell us that might be relevant for understanding and preventing disordered or dysfunctional children or adults?  But the explicit discussion, as opposed to these larger questions, the explicit discussion will be the science itself, neuroscience in the morning, psychology in the afternoon, and at the end of the day we'll have a chance to take stock of what we have done and how far we have come.

It's my great pleasure to welcome Dr. Thomas Jessell who is Professor of Biochemistry and Molecular Biophysics, the Center for Neurobiology and Behavior, and Howard Hughes Investigator, at Columbia University.  He is a distinguished researcher in the field of brain development.  It's a great pleasure to welcome you to the Council.  Apologies for detaining you, and we very much look forward to your presentation.  Dr. Jessell has asked me to announce that he would very much welcome our interruptions if we have questions or things on clarity.  He wants to make sure that we're following.  Dr. Jessell, the floor is yours, and thank you again.

DOCTOR JESSELL:  Well, first I would like to thank Dr. Kass for this opportunity to participate in this discussion of brain science and its relation to behavior.  And just to echo these comments that I really would encourage interruptions, comment, dissent, clarification.  If I lapse into jargon, then please bring me back to clarity.

Perhaps in the light of the first session this morning, an interesting place to start this discussion is in fact early in embryonic development, because it's at a relatively early stage in development that nervous systems form, that nerve cells are generated, and that those nerve cells begin to acquire identities that drive the subsequent formation of connections within the developing brain.  And one of the things that I'd like to suggest or argue in my comments this morning is that to a large extent the precision with which those connections form governs the intrinsic behavior or repertoire of any organism, whether it be a child, any type of mammalian organism, even lowly invertebrates.  Behavior is in large part dependent on the nature of the circuits that exist within those nervous systems. 

Now that is not to say that the wiring diagram, if you like, of the nervous system is the only determinant of behavior.  I think we've understood for many years that this provides an architectural substrate upon which environment and experience then mold those connections and refine those connections to produce the full, rich repertoire of behaviors that any given organism is characterized by.

So one of the things I'd like to discuss this morning initially at a relatively reductionist level is really to review what the field in general has learned about the nature of brain development during embryogenesis and postnatal development.  What is the relationship between genes, neurons, circuits, and behavior?  What are the molecular determinants that begin to establish the structure of the nervous system?  Then discuss the interplay between these genetic programs and environmental influences.  When does the nervous system cease to develop, if you like.  When is the pattern of connections established in a way that cannot be changed?  And our views on that have also changed rather dramatically over the last 10 to 20 years.  So we're dealing with questions of plasticity of the nervous system in relation to circuits and the way that those circuits influence behavior.  So these are all normal developmental processes, if you like, and perhaps if we have time at the end I will turn to the way in which those normal developmental processes become subverted in brain disease, in various types of neurological and psychological, psychiatric disorders.  Now those are very large problems, so I think at best I will be really scratching the surface on some of those later issues.

So just to put things into a general context.  Now, I hope that everybody can see some of these images, because some of my comments will really be dependent on them.  And those on my left are in danger of being attacked by this laser pointer, but I think we're working at the moment.  So what you are looking here is in very superficial terms the process of human brain development as a function of the nine months of gestation.  And so somewhere within the third to fourth week, the nervous system begins to form.  So cells in one of the major germ layers of the embryo, the ectoderm, make a decision that they're going to acquire neural character as opposed, for example, to acquiring the properties that eventually give rise to skin.  So the first steps in the formation of the nervous system occur at a surprising early stage.  And then as you can see because this is drawn relatively to scale, what happens over the subsequent eight months of embryonic development is a process by which the nervous system at least in large part accumulates large numbers of cells.  So the nervous system is exceedingly small at these early stages, but as you can see, by the time an embryo is born at nine months of gestation, there is a very highly organized nervous system which is much, much larger than the anlage that was seen at three to four days.  And so what we're really looking at at this period, and this process continues, not just in embryonic life, but in postnatal development.  Neurons continue to be added. 

So in a sense what the field of developmental neuroscience at these early stages has been trying to address are two basic questions.  So one of these relates to numerology.  So these are estimates, but the human brain is thought to contain some 1011 neurons.  This is a staggeringly large number of neurons.  And it also contains, and again this is simply an estimate, at least 1,000 different classes of nerve cells.  So by comparison, with most other tissues and organs in the body, the extent of cell diversity inherent in the nervous system is observed at a much more extreme level than in the liver, or in the heart, or in other tissues.  And so one of the major questions is to understand how during development the nervous system controls the number of nerve cells that are produced. 

And the other thing that this image shows is that not all nerve cells, once they're produced, are the same.  Individual nerve cells have discrete functional properties, and some of those functional properties are inherent or derived from the fact that the morphology, the shape, the structure of those nerve cells is markedly different.  So on the right-hand side of the screen here we're looking at one nerve cell that is found in a part of the brain called the cerebellum that is involved in motor control and many other functions.  And you can see that that cell, that neuron, looks very different from a neuron found in the retina that is involved in visual processing.  So one of the things that development does is ensure that not only do you generate very large numbers of neurons within the developing human brain, but you make these neurons different from a very early stage in fundamental structural ways that presumably influence their later functional properties. 

And I'll talk a little bit about what we currently understand about how these two problems of generating neurons and making neurons different are achieved at a developmental level.  Now these neurons don't exist in isolation.  The functional property of the neuron is dependent on that neuron becoming incorporated into a functional neural circuit, a network of neurons interconnected in different regions of the brain such that the combined activities of many neurons in different parts is necessary to produce a given behavior.

So the problem becomes even more complicated at this point.  So if we look at a typical region, for example the cerebral cortex, what we're seeing here is a complex, dense mesh work of neurons.  And this has been appreciated from classical anatomical techniques for the last century or more.  So each of these individual neurons as you can see from their morphology is subtly different from their neighbors.  One of the questions is how do these differences in morphology, these differences in structure, relate to the types of connections that they produce. 

So the two general questions that I want to begin to address, at least in the first part of my comments, are really going to be the issue of the impact of genes and genomes on neurons, on neuronal identity, and the way that those neurons begin to assemble interfunctional circuits.  So if you like, this is a reductionist view in which many aspects of brain organization are achieved through a genetic program to result in a wiring diagram of the brain.

So how are neurons generated?  This is perhaps the fundamental problem, the event that has to proceed if all other aspects of circuitry and behavior are going to be achieved.  And this is a problem that has been appreciated for, again, almost a century.  But it's only very recently that we have any molecular understanding of the way in which a cell in a primitive ectoderm acquires a neuronal property.  And this is a process that is reiterated many, many times to produce this vast diversity of neurons that exists in the human brain.

And so if we look from classical studies by Pasko Rakic and others, what we're looking at here is a small region of the developing brain, in this case a region of cortex.  And so in this region what you can see is a layered, a striated structure here.  One particular region called the ventricular zone, which you can't really see properly here, is the site of the precursors that will give rise to nerve cells.  These are neuro-precursors if you like.  They're stem cells in a particular context of neural development.  So these cells lie at one side of this epithelium, this sheet of neural cells.  And those cells divide under tightly controlled programs.  And the process of division here will determine whether that precursor cell continues to remain a precursor cell with a capacity to divide further, or whether that cell will leave the cell cycle and acquire so-called post-mitotic neuronal property.  One of the characteristic features of neurons is that once they're generated, they never undergo further divisions.  So this is a crucial event in determining the number of cells that populate the nervous system to determine how many of the precursor cell population remain, and how many post-mitotic non-dividing neurons are produced.

And the classical view until a few years ago had been that these cells divide in this restricted germinal or ventricular zone, and then they migrate through a complex process series of cellular events away from this germinal zone into their eventual settling positions in other regions of the nervous system.  And one of the ways that they're thought to undergo this migration process is along a series, if you like, of tram lines, or structural elements called radial glial cells which act as conduits for this migration process.  So really there are two processes going on here at these very early stages.  The process of cell proliferation coupled with the decision to give rise to a neuron, and then the migration of the neuron along these processes. 

Until very recently, and part of the reason I'm mentioning this, is to indicate that some of our thinking on these processes, even though the problem has been identified in classical terms.  Some of our thinking and some of the information is really very, very recent.  So much of what I'm saying is really a current 2004 view of these processes.  But this is still a field that is in a state of considerable flux.

So the classical view, which is shown on the left-hand image here, is that neurons achieve their final position within the nervous system through this migration.  They ensheath, they intertwine around these radial glial cells, and that's the way they move.  But the radial glial cell and the neuron have been thought of distinct cell types with no relationship.  What we now know from work in the last five years or so from many people is that this is certainly true, but this is an oversimplification, because it turns out that the radial glial cells, these structural elements, not only serve as a scaffold for neuronal migration, but they also represent in many ways the precursors of neurons themselves.  So the radial glial cells have a dual role.  They not only generate neurons, but they then act as a scaffold.  And I'll just give you one example of this new view.  So here we're looking almost in real time at one of these radial glial cells.  You can see its processes spanning the length of the future cortex.  And if we follow that cell in real time, although I'm showing it in a series of static images, what you can see is this cell divides at around Time Zero.  And then there are two cells.  And as we follow with time, one of the progeny remains in the ventricular zone, presumably to remain a precursor cell, but the other cell begins to migrate along this structural element.  And by using various genetic markers, some of which are not showing actually on this slide here, what we can see - there's a slight technical problem here, because this cell would be labeled Red with a neuronal molecular marker.  So this type of real-time imaging here is showing that radial glial cells are in fact the precursors of neurons.  So this is a piece of cell biology that has emerged over the last few years that has radically changed the way that we think about neuronal production in the developing brain.

So can we move then from this cellular description of where neurons throughout the central nervous system, throughout the brain, come from, into a molecular understanding of this decision.  What are the genes that determine whether a cell remains proliferative, or whether it exits the cell cycle and acquires a neuronal fate And over the last decade there have really been very substantial advances in understanding the nature of genes that drive this neuronal differentiation process.  And one can show that some of these genes are sufficient when expressed in a proliferative cell to produce the neuronal phenotype, to produce the neuronal fate.  And I'm showing you one example of this.  The nature of the genes don't really matter here.  But what we're looking at is a top-down view of an early vertebrate embryo.  And so this has a left side and a right side.  And on the left side, if we concentrate on, for example, the image in Panel B, you can see a few blue dots here.  Those are the neurons that have been generated under a normal developmental condition.  And you can see that there's a sea of non-neuronal tissue in which are interspersed individual nerve cells.  So in this experimental situation, a single gene that is one of these genes that promotes neuronal formation, has been introduced into these precursor cells, and the consequences for neuronal production have been examined.  And what I hope you can see is that to the right of this dotted line there is a vastly greater number of nerve cells that have been generated as a consequence of introducing that one gene.  So neuroscientists now are beginning to be able to control this early decision as to whether to give rise to a proliferative cell or whether to generate a nerve cell.  And these are genes that are operating in the embryo normally, and this is part of a genetic program that in a sense is determining the fact that the human brain has 1011, not 1012, not 1010 neurons.  So there's a tightly orchestrated genetic program that ensures the production of neurons.

This image indicates, at least with this sort of color-coding, that all neurons are the same.  So there are really two problems here.  One, as we saw, to generate large numbers of neurons.  But the second is to make those neurons different.  And so if we consider that the human brain at the time of birth contains some 1,000 different cell types, how are those different cell identities?  They're all neurons, but each of them acquires a characteristic identity that suits its particular later function.  How is that diversity of neuronal identity controlled?  So if there are 1,000 different classes of neurons, does that imply that there must be 1,000 different signaling mechanisms that are operating with one pathway of signal, one signal per neuron, which would provide extreme constraints on the number of genes necessary to generate this diversity.  Or has the nervous system evolved more efficient ways of generating diversity from a relatively small number of signaling systems.  So as a generality in the nervous system, as in the embryo as a whole, the way in which cells acquire their different identities is through the intersection of two different pathways. 

The fate of no cell in the nervous system is really preordained from an early stage.  So there is no such thing as a central nervous system homunculus.  Cell identities are acquired because of their position in an early developing neural epithelium.  And what their position really is doing is defining the environment to which that individual neural precursor cell is exposed.  So if you're in one position you're exposed to a different set of signals then being in a different position.  So really, neuronal generation and neuronal identity involves the intersection of environmental signals with programs of gene expression that are going on within the nerve cell itself.  And it turns out that this vast diversity of neuronal identities, 1,000, 2,000, whatever that number turns out to be, is generated through a surprisingly small number of environmental signals, where those signals operate in combinations.  So the nervous system has evolved efficient ways of using a small number of signals to generate this vast degree of diversity. 

And I just wanted to give you one principle by which diversity comes, how you can generate many different cell types, neuronal cell types, from just one signal.  And it turns out that some of these signals, which are secreted proteins produced by one cell which influence neighboring cells, have been termed morphogens.  So what we're looking at here is an early primitive region of the nervous system.  This particular region is going to give rise to the spinal cord, but if you looked in the brain, you'd see a very similar morphology. 

So this is the nervous system.  These are non-neural tissues.  There are localized sources of these secreted factors in non-neural tissues.  You can see by the shading of the color blue here which represents a site of gene expression.  And one of these proteins, which has been known as Sonic Hedgehog for various reasons, is a secreted protein.  That protein functions as a morphogen.  So what a morphogen is is a protein that can induce or change or compose different cell fates as a function of the different concentrations of that one substance that a cell is exposed to.  So the exposure of a naïve precursor neural progenitor cell to a low concentration of this factor will induce one neuronal fate.  But as you double the concentration of that factor, that same recipient cell acquires a different fate.  And so in this way, one single signaling factor, by acting at different concentrations can induce different classes of neurons.  And so for example, the local source of this factor establishes a concentration gradient throughout the early nervous system, the neural epithelium.  And in this particular example at least five different classes of neurons - their identity doesn't really matter - are generated in response to this one factor through twofold differences in concentration.  So this type of mechanism is used again and again in the nervous system.  In some cases it's concentration, in some cases it's the convergent exposure to two different signals that results in differences in identity.  But numerically, a relatively small number of these signals imposes the vast degree of neuronal diversity that we see within the nervous system.

So I want to switch now.  And you'll see that this is going to be of necessity a relatively superficial overview of all of these processes away from generating neurons.  Let's assume that you have generated vast numbers of neurons in the early nervous system.  How do those neurons begin to form connections?  Because one of the things that these early p