Meeting Transcript
January 15, 2004

Wyndham Hotel
1400 M Street, NW
Washington, D.C. 20005

COUNCIL MEMBERS PRESENT

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

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

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

Alfonso Gómez-Lobo, Dr. phil.
Georgetown University

William B. Hurlbut, M.D.
Stanford University

Charles Krauthammer, M.D.
Syndicated Columnist

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

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

Gilbert C. Meilaender, Ph.D.
Valparaiso University

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

Michael J. Sandel, D.Phil.
Harvard University


INDEX

• Session 1: Stem Cells: Council’s Report to the President
  Release of "Monitoring Stem Cell Research: A Report of the President's Council on Bieothics"
  
• Session 2: Biotechnology and Public Policy
  Staff Working Paper, "U.S. Public Policy and the Biotechnologies that Touch the Beginnings of Human Life: Draft Recommendations, Revised"
  
• Session 3: Neuroscience, Neuropsychiatry, and Neuroethics: An Overview
  
• Session 4: Neuroscience and Neuroethics: Reward and Decision
  

WELCOME AND ANNNOUNCEMENTS

CHAIRMAN KASS:  Happy New Year everybody.  Welcome to this, the 15th meeting of the President's Council on Bioethics.  Welcome to Council Members, and to staff, and to members of the public.

I would like to acknowledge the presence of Dean Clancy, our Executive Director, the Designated Federal Officer, in whose presence this is a legal meeting.

And there is one other announcement, and an elevation in the staff, of Yuval Levin to the Deputy Executive Director's position, and I want to congratulate Yuval.

SESSION 1: STEM CELLS: COUNCIL'S REPORT TO THE PRESIDENT

CHAIRMAN KASS:  The first session this morning is devoted to officially releasing the latest council document, our third report, a report, entitled, "Monitoring Stem Cell Research," which council members should find at their places.

This report to the President is offered as an update on the state of human stem cell research, reviewing both the science of stem cells, and the public and scholarly debates that have arisen around it over the past several years.

We as a Council have been looking at these issues and thinking about this subject from our very beginning.  The President decided to create this Council in the course of his review and decision regarding government funding of embryonic stem cell research, and one of the things that he asked us to do when he created the Council was precisely to keep an eye on this field for him and for the American public.  And that is what we have done.

We have devoted a large number of Council sessions to this subject, at least 14 sessions by my count, beginning at our third meeting in April of 2002.  We have commissioned review articles and heard presentations from prominent researchers in all the various areas of human stem cell research. 

We have heard from ethicists who have thought about these issues for years.  We have heard from experts in the legal and legislative side of these questions, from people working on the stem cell research in the private sector, and in publicly funded studies.

We have heard from patient advocates, and we have heard from the Director of the National Institutes of Health, and the Commissioner of the Food and Drug Administration, and many others who gave us their views and who reported on the facts in oral and written presentations to the Council.

The staff has conducted vast reviews of the literature, and special thanks to Lee Zwanziger for the review of the ethics literature, and to Dick Roblin for monitoring and keeping track of the scientific literature. 

The Council's report draws on all of that, and on a great deal of additional discussion and work by Council members and by the Council staff.  It synthesizes what we have learned through monitoring in what is essentially an update on the present state of things more than two years after the adoption of the administration's current policy on federal funding of embryonic stem cell research.

The report has gone through multiple drafts, received extensive and painstaking comments from members, reviewed equally painstakingly by the staff, and the scientific chapter, Chapter 4, has been additionally reviewed for accuracy and fairness by some prominent stem cell researchers not connected with the Council. 

We are grateful to all those who have helped us in the various phases of our work.  To understand the document it is very important to understand what I mean when I call it an update. 

Because the field and the current policy are so young, this report can be no more than an update.  It summarizes some of the more interesting and significant developments since August 2001, both in the basic science and medical applications of stem cell research, and in the related ethical, legal, and policy discussions.

But it does not attempt to be a definitive or comprehensive, or ultimate study of the whole topic.  It contains no proposed guidelines or regulations.  Indeed, it contains no specific recommendations for public policy.

That was not our task or our purpose here.  Rather, it seeks to shed light on where we are now ethically, legally, scientifically, and medically, in order that the President, the Congress, and the nation, may be better informed as we all consider where we should go in the future.

To be sure, Members of the Council do have particular views regarding the best public policy on this subject, and there are differences of opinion on this subject among us. 

But in this report, we seek not to settle that debate, but to improve it.  The debates about this subject in the past two years have often suffered from a great deal of confusion, frankly, on all sides.

By offering the best available information on both the science and the ethical arguments, gathered together in once place and available for any interested party to consult, we hope that this monitoring document will be able to establish a clearer picture of the facts and the contending opinions so as to act as the foundation for a better informed continuing discussion of this important policy topic.

Our aim here, therefore, is in a sense limited, but it is still a very large, extremely important one.  With that as a general preface, let me give you a short guided tour of the document, beginning with its more specific goals.

The report has, I would say, four basic goals.  First, to explain and clarify the existing federal policy regarding taxpayer funding of stem cell research and its implementation.

Second, to offer an overview of the public debates surrounding stem cell research in the past two years.  Third, to provide an update on developments in all areas of human stem cell science in the past two years.

And finally, a kind of over- arching goal that defines for us the entire project, to convey the moral and social importance of the issue at hand, and to demonstrate how people of different backgrounds, ethical beliefs, and policy preferences, can reason together about it in a constructive and publicly responsible way.

And those of you who have copies may want to follow the table of contents.  I am just going to run through and highlight a few of the important points.  The report opens with a brief introductory chapter, in which we take up some very important questions of context, terminology and purpose.

Then in the second chapter, the report addresses - - first addresses itself to the first of the aims that I have described, namely to describe as clearly as possible the present federal funding policy, its character, and its implementation. 

The policy, I think it is fair to say, is founded in a desire to promote important biomedical research without using public funds to endorse, support, or create incentives for the future destruction of human embryos.

The report tries to describe this aim in the context of its history, of the history of federal funding of embryo related research, including the Dickey Amendment, and in the context of what we take to be the legal, ethical, and prudential foundations of the policy.

We also give some consideration to the unique and important questions that surround all federal funding decisions.  What does it mean for the government to support an activity with taxpayer money?

What sorts of considerations should go into a funding decision, and the Council suggests that a funding decision is always an ethical, as well as an economic one. 

Finally, in the second chapter, we try to lay out the basic facts regarding the implementation of the Administration's funding policy over the past two years, to explain how the NIH has put the policy into action, and where things stand in terms of available funding and available lines.

There has been a lot of confusion about this, and I think it is critical to put the facts out there as fully and plainly as possible.  The basic facts on that front are that there are 78 lines of human embryonic stem cells that have been found to be eligible, eligible for federal funding under the current policy.

That is, those lines were derived before the date of the President's speech.  But these lines are in different stages of characterization and development, so that only some of them have been developed to the point that they are actually available to researchers who want them today.

Others are still being developed, and, of course, it is impossible to know in advance how many of these will finally in fact prove to be usable, the important distinction between what is eligible and what is available.

And here we run into one of the difficulties of reporting on a field that is constantly changing.  The number of lines available to researchers has been growing over the past two years as more of the eligible lines have been developed and characterized. 

A year ago, about five lines were available.  This fall when we were completing this report, the number had risen to 12 lines, and so 12 is the number listed in this document.

But since that time, at the end of December, the NIH reports that three additional lines have become available, and so the number is now 15 lines rather than 12. 

We note very clearly in the report that this number will continue to change and so this very recent increase in the number of actually available lines only underlines that fact, but it does not change any of the major points made in the document, and in the final version of this report, we will update those facts, as well.

The funding policy, though it limits the targets of funding to the eligible lines, does not directly delimit or restrict the amount of money, or other resources that the NIH may invest in human embryonic stem cell research.

The amount invested is a decision left to the NIH and the Congressional appropriations process is largely a function of the number of qualified applicants for funding, and of the NIH's own priorities and funding decisions.

In Fiscal Year 2002, the NIH devoted approximately $10.7 million to human embryonic stem cell research, and based on an estimate that we received in September of 2003, it will have spent approximately 17 million in Fiscal Year 2003.

Still, however, only roughly ten percent of the amount spent on adult stem cell research.  This amount is expected, as the field and the number of grant applications grow.

Having laid out the character and state of implementation of the present funding policy, the report then turns to a review of the public debate, which, as you all know, has been quite active and quite contentious over the past two years. 

A great deal has been written and said, and there have been Congressional hearings on these subjects, many books and articles published, many different sorts of arguments put forward on all sides, and we have been monitoring these activities for over two years.

The third chapter of this document, which is the longest chapter, tries to offer an overview of these debates.  It makes no claim to be absolutely comprehensive, of course. That would be more than any document like this could hope to do.

But I do think that it describes and organizes all the major strands of the public debate, and that it presents these in a way that might allow people to get a sense of what the issues are, and what the arguments are, and what there is to think through.

We have organized the discussion in relation to the current policy and its moral and prudential underpinnings so that the reader may see the way in which the ethical debate can have practical traction regarding policy.

Subtopics include challenges to the moral aims of the current policy, challenges to some of the internal features of the current policy, efforts to try to cut the Gordian Knot that is the moral standing of human embryos, and other social and public issues less frequently discussed, but perhaps no less important.

As we conclude our overview of the ethical debates, strong and powerful - - and I quote from the report - - strong and powerfully argued views have been presented on various sides of each of these questions.

For now, neither side to the debate seems close to fully persuading the other of the truth it thinks it sees, but the rich and growing ethical debates do suggest the possibility of progress toward greater understanding of the issues, and toward more important and informed public decision-making as all parties to the deliberation appreciate better just what is at stake, not only for them or their opponents, but indeed for all of us.

In presenting these arguments, we have tried to present them, the arguments and the counter- arguments, faithfully and accurately, so that each reader can judge them for himself or herself.

I should add, by the way, that some of the points and some of the arguments described actually originated in the discussions of this Council, and, of course, those are clearly cited in the text, just like all of our other sources.

Finally, and, of course, absolutely crucial to any discussion of human stem cell research, is a rigorously informed sense of just where the science now stands, both in basic research and in therapeutic efforts using animal models.

We have sought to offer readers of this report both an explanation of what the science of stem cells involves, and an update on recent developments in the current state of human stem cell research, understanding, of course, that the field is always changing.

At the heart of this effort are seven commissioned review articles written by leading scientists covering the published literature as of last summer on embryonic stem cells, and embryonic germ cells, adult stem cells, multipotent adult progenitor cells, mesenchymal stem cells, and stem cells from cloned embryos. 

And a seventh paper on the problem of immunological rejection, one of the obstacles to eventual successful tissue transplantation.  These papers appear unedited in their entirety, in the appendices H through N in the report.

As an adjunct to these Commission review articles, the fourth and final chapter in the body of the report proper seeks to enable especially non- scientific readers to appreciate the reasons for the excitement over stem cell research, the complexities of working with stem cells, some early intriguing research and therapeutic findings, and the difficult road that must yet be traveled before we can reap therapeutic and other benefits from this potentially highly fertile field of research.

Along with the scientific appendices and several other Commission papers on ethics and policy that are offered as appendices, the report also includes what we have called an embryo primer.

This is the first appendix of the document, and it offers basic facts about human embryology that we think any reader should know before coming to judgment about the issues that surround human embryonic stem cell research.

The scientific facts don't simply settle the moral or policy questions by themselves, but they are, of course, quite crucial to any understanding and determination on that subject.

In short then, the report aims to describe the present policy to review the social and ethical debates, and to offer an update on scientific developments.

And these three aims, as I have said, are overached by this desire to convey to the reader the tremendous importance of the issues at hand, and to show that we, as a society, can think about them together.

I think the Council's work in putting the document together demonstrates that, too.  Throughout the Council's deliberations, and in this Monitoring Report, mostly successfully, to acknowledge the strengths and importance of opinions and concerns held by people with whom we personally might disagree.

We have aspired to be careful and fair in our approach, precise in our language, accurate in presenting data in arguments, and thoughtful in laying out the various issues that remain before us.

These have been our aims in this document, and I would like to think that the report achieves its aims, though that is for the readers to judge.  We do hope that this will help to inform the very important and complicated ongoing public debate.

I would like, in closing, simply to offer special thanks to members of the staff who are especially responsible for this report.  Everyone had a hand in it, but Lee Zwanziger, Dick Roblin, and Yuval Levin.

That is my synoptic view of the report.  The procedure is that there are a few members who have asked to make brief comments on the report, and then we will open the floor to questions from the press.

Two of our members are still in transit - - actually probably Charles as well.  Elizabeth Blackburn, who cannot be with us today, has sent in a comment which she has asked me to read, and let me begin with that, while others who have asked to speak will come next.

This is from Elizabeth, and I quote:  From the scientific published literature and peer review journals on stem cells, a major message that can be distilled is the vast difference that currently exists between embryonic and adult stem cells as sources of material for research and clinical purposes. 

Briefly stated, human stem cells have been isolated from a variety of embryonic, fetal, and adult tissue sources.  However, enormous differences exist in purity, properties, data reproducibility, and understanding of cells from these different sources.  Paragraph.

First, embryonic stem cells have been extensively and rigorously demonstrated in animal models to have great utility for scientific studies, and this work has also shown that human embryonic stem cells, together with fetal stem cells, show the greatest promise for clinical applications.

As well as therapeutic uses, important additional potential applications include studies of stem cells bearing complex genotypes susceptible to poorly understood common human diseases, and testing and screening throughout efficacy.  Paragraph.

Second, the only well- characterized adult stem cells that exist to date are hemopoietic stem cells.  These are the only ones that have been well characterized in multiple laboratories and are reliably understood. 

Currently, major difficulties exist with other types of adult stem cells reported to date.  Research on some of the reported adult stem cell preparations may conceivably in the future demonstrate that they, too, like hematopoietic stem cells, can also be, "single cell cloned," expanded considerably by growth in vitro with retention of normal chromosome structure and number, and preserved by freezing and storage at low temperatures.

But it should be strongly cautioned that this is not been done, and even if possible, it will be technically very demanding.  Paragraph.

Furthermore, in the case of MAPCs, and that is the multipotent adult progenitor cells, the work of Catherine Verfaillie, and furthermore in the case of MAPCs, for example, the reported isolation and properties of MAPCs must be reproduced in additional laboratories for any reliable interpretation of the results reported with these cells. 

After considerable effort this has not been achieved to date.  Thus, it remains extremely difficult to interpret these results rigorously.  Therefore, it is important to note that in light of this failure to reproduce the reported results as of now, the significance of the reported isolation and properties of human MAPCs is still left unclear, as is, therefore, their potential as a source of stem cells for clinical purposes.

Hence, a strong overall caution is that many of the reports of the properties of cells differentiated from adult stem cell preparations, other than hematopoietic stem cells, are, to date, preliminary and still very incomplete.  Paragraph.

If and when the results to date with any isolated and characterized adult stem cells are validated, it will then be very important to compare their properties, and those of any more differentiated cells that can be derived from them with other stem cells sources. 

These sources include adult stem cells, such as the well characterized hematopoietic stem cells, and the human embryonic stem cell preparations that have already been more extensively characterized.

Two major considerations argue strongly for non- commercial federal peer- reviewed funding to be made available for this work.  The first is the sustained effort this work will require, the second is the importance of reliable and unbiased design of experiments, and of open public availability of the complete findings arising from the work.

I have been told that, I think, Alfonso Gomez- Lobo has a comment, and I believe Robby George.  Alfonso, please.

DR. GÓMEZ-LOBO:  Thank you.  We have in our hands a valuable document that has been carefully crafted by our admirable staff under the guidance of Dr.Leon Kass.

The document contains illuminating presentations by the experts we invited to instruct us on different topics.  And it also incorporates a significant number of contributions from members of the Council who spent long hours sifting through the successive drafts.  It is, on all accounts, a significant achievement. 

What I would like to do in this brief statement is to express my own exegetical hopes, that is, my personal hopes with regard to the way that the report will be read and understood. 

My first hope is that the abundance of scientific information and funding policy questions would not obscure the fact that this is a report issued not by a scientific panel, but by a council on bioethics, a body primarily expected to address ethical concerns. 

It is my hope that readers of the report will realize that by the end of the day there is but one central ethical concern in embryonic stem cell research, namely, that at the present time human embryonic stem cells can only be obtained by deliberate destruction of live human embryos. 

It is my hope that readers will also realize that research on adult, or non- embryonic stem cells, raises no equivalent ethical concerns because no destruction of human organisms is required.

In spite of the fact that opinions on how human embryos should be treated are deeply divided, my hope is that the report will not be read as espousing skepticism on whether we can reach a rational solution to the question of when the life of a human being begins, and when respect for that life ought to begin.

I hope that our further scientific work in animal models on the embryonic stage, especially on twinning, will allow us to make better inferences on those topics, and I hope that further conceptual work on the notion of  "special respect" and "intermediate moral status" will show whether or not those concepts are adequate to express what we owe to humans who find themselves at a stage we all went through early on.

My own view is that the notion of special respect allows us to discriminate among embryos on the basis of the circumstances in which they have been placed, and fails to raise a protective barrier in front of hundreds of human embryos that are genetically no different from those that will not be used for research, and will be allowed to further develop. 

Finally, I hope that reflection on the fact that every human being alive today went through the embryonic stage would lead us to understand that the fruits of embryonic stem cell research will come at the disturbing price of humanity turning against itself.  Thank you.

CHAIRMAN KASS:  Robby George.

PROF. GEORGE:  Thank you, Leon.  Today's report does not seek to settle the question of the justice of human embryo destruction and the cause of biomedical research. 

On that question, it sets forth the reasons why some of us oppose the taking of human life even in the embryonic stage, and others believe it to be justified where it is done with the realistic hope of helping people who are afflicted with serious illnesses and disabilities.

Nor does our report offer an evaluative judgment of the policy put into place by the President of the United States on August 9th, 2001, restricting federal funding of research involving the destruction of embryonic human life. 

On this question, too, we are divided as a nation and as a Council.  The report makes a contribution, however, by clarifying the grounds and meaning of the policy, and by providing reliable information as to its implementation and impact. 

As for the grounds of the policy, and its coherence, or possible lack of coherence with this or that view of the moral standing of the human embryo, and the moral permissibility of embryo destruction and research, the report makes clear that there are, on the Council, differences of opinion.

Again, the report does not seek to resolve these differences, and so it should be understood that the purpose of the report is descriptive rather than prescriptive.

It sets forth facts and it does not take positions on matters on which the council is fundamentally divided.  Those of us who believe that a policy of funding research involving the destruction of human embryos would be unjust share with our colleagues a desire for stem cell science to go forward unimpeded where research can be conducted without taking nascent human life.

We are heartened by the clinical successes of adult stem cell based therapies.  Such therapies are already in very encouraging clinical trials in humans for Parkinson's disease, multiple sclerosis, immune- deficiencies, sickle- cell anemia, and other afflictions.

Certain adult stem cell based therapies have already enabled some patients with Type- I diabetes to throw away their insulin needles.  While taking into account Dr. Blackburn's caution about the so far preliminary and incomplete status of research on multipotent adult progenitor cells, MAPCs. 

We believe that promising and ethically unimpeachable research of this kind should be encouraged and generously funded.  We do not wish the controversy over embryonic research to mislead the public into supposing that there is something ethically suspect about stem cell research in itself.  There is not. 

There are forms of important stem cell research that Americans can unanimously and enthusiastically support, despite our differences on other forms. 

It is important not to hype adult stem cell research, but it is equally important not to obscure its achievements and very considerable promise.  By the same token, it is important not to hype the benefits or promise of embryonic research.

I do not believe that the evidence supports a claim that embryonic stem cells show the greatest promise for therapeutic uses.  The difficulty in controlling them and their tendency to tumor formation makes them too dangerous for clinical trials at this time.

Very recent studies suggest that embryonic cell cultures may tend to accumulate extra chromosomes over time, the very chromosomes associated with the formation of cancerous tumors.

These problems may or may not eventually be solved, but plainly they need to be soberly taken into account in any presentation of the matter.  At the same time, no one would wish to prevent or impede research if stem cells of the type currently derived by destroying embryonic human life could be derived without resort to embryo destruction. 

The report that we issue today for the first time follows up a possibility raised by our colleague, William Hurlbut, in his personal statement attached to our earlier report on human cloning.

Today's report suggests the possibility, the possibility, of deriving cells from entities whose initial properties in certain ways resemble those of living human embryos, but whose direction of growth and trajectory of development due to epigenetic differences are quite distinct. 

Such entities, roughly analogous to hydatidiform moles or other disorder growths sometimes appearing in nature would not qualify as whole living members of the human species, or the species, homo sapiens.

On no one's account would they be considered embryonic human beings.  If in fact these entities were capable of yielding embryonic type stem cells, these stem cells could be harvested without raising the ethical issue of embryo destruction. 

Whether entities thus envisaged can be produced is a matter of fact that I think should be explored.  Whether their production would raise ethical questions that perhaps Dr. Hurlbut and I have not considered, others have to say.

But given the ethical impasse in the country and on the council on the issue of embryo research, I am glad that our report today elevates the profile of Dr. Hurlbut's proposal.

I commend him for seeking to address a vexing and divisive issue with a creative solution that would honor the concerns of reasonable people of good will across the spectrum of opinions.  Thank you.

CHAIRMAN KASS:  That was all I knew of people who had asked for comment in advance.  If I am correct on that, then I don't know that we have members of the press here that would like to ask comments or ask questions about the report.

We have a microphone which is over to the side.  Could we have that moved more centrally.  Are there any questions?  Please, for the transcript, would you mind stating your name, and if there is an identification that goes with it, it would be helpful.

MR. OTTO:  Yes, I am Alexander Otto, and I write for the Bureau of National Affairs Medical Research, Law, and Policy Report.  Recently, New Jersey just passed a law explicitly making legal research on embryonic stem cell derived from human cloning. 

It follows California's similar action of a few years ago, and, of course, bills are pending in other states to do the same thing.  How does this state action affect the debate on the federal level?

It is a very general question, but I would like to see it addressed by the panel, if possible.  Thank you.

CHAIRMAN KASS:  This is not a question about our report, right?

MR. OTTO:  Right.  It is not.  It is more a general question, if you could address it.

CHAIRMAN KASS:  Well, I am sort of two minds, and one could say that this would be a lengthy off- the- subject topic that we probably shouldn't go into.  On the other hand, we don't often get questions from the floor, and maybe a sentence or two wouldn't be out of order, and if I get it wrong, my colleagues will correct me. 

There is no law in the United States forbidding stem cell research or research on human cloning at the present time.  Those state laws are in a certain way gratuitous. 

They are simply declaring not so much that certain kinds of things are legal there.  Those things were legal there before.  They have given sort of the state blessings and announce that this state is in favor of those things in an affirmative way. 

Not unless and until there would be a national policy that would declare some of those things illegal would there be any kind of conflict between those state laws and what transpires at the federal level.

The federal question, at the moment, here is a question of federal funding and the funding policy.  There is no ban on any kind of embryonic stem cell research at the federal level.

So, I mean, there are different dispositions at work in these States, and in the Congressional debate, but I don't think - - I think I am right in saying that there is absolutely no conflict at all.  My learned legal counsel.

PROF. GEORGE:  I just would enter one caveat about that.  I don't think it is quite right to say that there is no law in the United States restricting those kinds of research.  I believe that there are some state laws that go in the opposite direction - -

CHAIRMAN KASS:  No, I understand, but there is no federal law.  Excuse me.  The states are free to be more restrictive, but - -

PROF. FOSTER:  Well, let me just make a brief comment, and I can only talk from the state of Texas where I am.  The driving force for the states has to do with economics. 

Everybody in the world wants to have biotechnology in their state, and the companies, the economic impact of not saying that a state will support this type of activity is extremely powerful, even in a conservative state like Texas.

In fact, I was at a two-day conference just this last week about this issue after the new state decision.  So I think that the driving force there is independent of what we do here, but it powerfully economic.

I mean, the big states are going to be terrifically hurt if their idea has to do with - - you know, no company will come, and no graduate students, or a few graduate students will come to the universities and so forth if you don't do it.

That is the concern, and I think it is the first thing.  The other thing that I mentioned that is not in the report is that at one point there have been five appellate court decisions about the nature of stored embryos.

So, there are legal decisions, mostly in divorce cases, in which the courts have - - and including very high courts, and I guess maybe the highest court in New York, and in Tennessee, that have basically decided that the embryo is deserving of special respect, I understand, Alfonso, that that term is very vague.

But have basically decided in terms of contracts and so forth that the stored embryos are to be dealt with like other property in a divorce if I understand that.  That is what legal people tell me the decision is.

So, all I am trying to say is that there are a lot of other things going on that are outside the ethical issues that we are talking about here. 

CHAIRMAN KASS:  Thank you very much.  Cynthia Cohen, please.

MS. COHEN:  I am Cynthia Cohen, and I work at the Kennedy Institute of Ethics at Georgetown.  I am a philosopher and a lawyer by training.  I was interested in the fact that the Council is not coming out with any new guidelines and regulations. 

The second charge that you have on page one here is not only to monitor stem cell research, but to recommend appropriate guidelines and regulations.  And you mentioned that you have not had that much time, that this is still a growing field, that there is a difference of opinion on the Council about some matters. 

But, I wondered whether, for instance why there is no recommendation for an oversight body as there is in Canada.  I have just been appointed to the Canadian Ethics Oversight Committee.

CHAIRMAN KASS:  Good.

MS. COHEN:  And they are concerned about doing a strictly ethical review of their stem cell research.  In the United States the NIH is in charge of review, and it is primarily a scientific review. 

There was a mention of some of the economic concerns that are arising.  As stem cell research spreads, patenting issues, questions about what is going on in the private sector, I think you would have recommendations about that. 

So I am just puzzled, and I hope that you can help me to explain this to readers of the journal when I write this meeting up.  Thank you.

CHAIRMAN KASS:  Well, thank you.  I guess there is several parts of an answer to that question.  I think the primary answer is that this field is young.  The current policy is very young.  The implementation of that policy moves slowly, although the NIH has made it very clear, and the evidence is considerable, that they have strained every nerve to get this thing up and running as fast as possible.

And it seemed to us premature to jump in and second guess the current arrangements before one has given them even a couple of years time to work.  Stem cells, human stem cells, isolation, embryonic stem cells, the first isolation reported in 1998.

The announcement of the new funding policy in August of 2001.  The lines just becoming available, and the funding sources just increasing.  The research only beginning to be reported. 

It seemed premature to, at this time, to do more than simply monitor and report what has been going on.  Down the road, we might very well revisit this after there has been more experience and more opportunity to see whether things are working, and what else needs to be done.  That would be part of the answer.

The other part of the answer is that the Council is interested in the larger question of oversight, monitoring and regulation of biotechnologies, and we have another project. 

And, in fact, the subject of the second session this morning, biotechnology and public policy, an investigation of those technologies that touch the beginnings of human life.

And I don't want to preempt the discussion of that topic, but there have been serious considerations about the possible need for new institutional mechanisms to oversee these matters, and to monitor them, and then perhaps to regulate them. 

I think it is fair to say that the Council on that subject is not yet in the position to make institutional recommendations so that we will be producing some kind of diagnostic document, with some interim recommendations.

But the larger subject that you ask about is pretty much on our minds, but we wouldn't think of isolating it just to the question of stem cells.  I think that would be kind of a two- part answer.

PROF. MEILAENDER:  Leon, could I just make one comment, in response to that?

CHAIRMAN KASS:  Yes, Gil.

PROF. MEILAENDER:  It's not as if we have made no recommendations either.  I mean, you have to remember that the first thing that we produced was a document on human cloning and human dignity, which though somewhat different, certainly is related to this general topic, and embroiled thus in aspects of this topic.

And we had recommendations, certain kinds of policy recommendations there, but majority and minority views.  So, you have to read this in conjunction with our other work, I think.

CHAIRMAN KASS:  Yes, and there, however, the question was that there was a particular legislative debate into which we were pitted.  And here - - and there was - - and here we enter with a request to monitor the goings on under the current policy as announced.

So that the situation is - - I mean, I think Gil is right, but the situations are not exactly the same.  Please.

MS. FRIEDEN:  I am Joyce Frieden, and I write for Ob- Gyn News.  You mentioned in your introduction that I think that 78 stem cell lines, I think, was the number that were available, and I just wanted - -

CHAIRMAN KASS:  No, that were eligible.

MS. FRIEDEN:  That were eligible for funding.  I just want to make sure that is the upper limit, and if you have any idea if any of those 15 that you said were currently available, and what you think the eventual number is.

CHAIRMAN KASS:  There is no way to know how many of these - - let me repeat.  Eligibility is defined by the announcement of - - when the President made his announcement that there would be funding for lines already in existence as of the date of the announcement.

And we have got some discussions and I don't want to rehearse the details of the policy, but to be eligible the embryonic stem cell line had already to have been derived and the destructive - - the embryonic destructive act had already to have taken place.

Before - - and let's say in the spring or the winter of the year 2001, the loose estimates were that maybe there were 20 such lines existing world- wide, and while the President was deliberating about that policy, people at the NIH were scurrying about.

And if I am not mistaken, when the policy was announced, it was something like they thought there were 64 such eligible lines.  Further research revealed that there were now, I think - - that there are now 78.

And who knows whether there is somebody who is harboring something someplace else that is eligible, but that is not the important question.  The important question, really, is how many of these eligible lines becomes sufficiently well developed, sufficiently well characterized, that the material transfer agreements are reached so that these become available to scientists for use.

The NIH monitors this carefully and it keeps a register of all of the eligible lines, and which ones then become available, and there are now, as of the end December, 15 such lines listed by the NIH.  The additional three lines coming one from Wisconsin, and two from Technion University in Israel.

But the NIH has a website for this, and they keep this information current.

MS. FRIEDEN:  Thank you. 

CHAIRMAN KASS:  And by the way, no one knows - - it would just be fruitless to speculate in advance how many of the remaining 63 lines will become available.  Further comments, questions?

(No response.)

CHAIRMAN KASS:  Let's take an earlier break and convene at, say, five after 10:00 to get started on the second session, rather than just sit.  Thank you very much.

         (Whereupon, at 9:44 a.m., the meeting was recessed and resumed at 10:22 a.m.)

SESSION 2: BIOTECHNOLOGY AND PUBLIC POLICY

CHAIRMAN KASS:  Thank you.  Welcome to Janet Rowley.  We are expecting Mike Gazzaniga and Charles Krauthammer, who are both in transit.  This is the second session on biotechnology and public policy, and is devoted to a discussion of the staff working paper, entitled, "U.S. Public Policy and the Biotechnologies That Touch the Beginnings of Human Life:  Draft Recommendations, Revised."

I think council members don't need much by way of rehearsal of what this project is, or what we are doing, and why.  Suffice it to say that we have for some time, really from the very first meeting, been interested in the monitoring and regulatory institutions that concern the uses of biotechnology in general, and that we focus that interest on the technologies touching the beginnings of human life where already established technologies of assisted reproduction now become joined with possible new developments growing out of genomic knowledge, and the availability of embryos for research.

We are on our way toward a report on this subject, the bulk of which will be a diagnostic section of some length reviewing where things now stand. 

A brief section already has been discussed and basically approved on policy options, both general and particular, and a last section which we discussed both in September and in October on interim recommendations, recommendations for the time being while the Council and the nation continue to deliberate about what if anything needs to be done to improve the way in which we now oversee, and monitor, and regulate these activities.

We in September had a discussion of the first draft of these recommendations, and it was a very spirited and somewhat woolly conversation.  We returned in October, where we made I think considerable progress amongst ourselves.

A number of things were clarified, and a number of issues in which it looked like we could find no agreement, and we managed to produce a kind of agreement amongst us. 

And the document has been changed extensively to reflect those conversations amongst ourselves with a number of things being removed that were contentious, and other things being refined.

I will say, and I think that I would like to put in the record that this latest draft also reflects changes that we have made in response to comments by various stakeholders, including patient groups and professional societies.

We have met with the - - we already met the last time with the President and the Executive Director of the American Society for Reproductive Medicine.  We have since met with representatives from RESOLVE, and from the American Infertility Association.

And I want to go through a few of the changes that have been made, because I would also like to say that to some extent the concerns of some of these groups have originated from at least a partial misunderstanding both as to the substance of our document, and our intentions.

Nevertheless, they have offered some very helpful comments, calling our attention to ambiguities or to problems that we might be causing of which we were not aware.

And we have responded in great detail to some of their concerns, and so that Council members don't have to sit with the last draft and the current draft, let me just highlight a few of these concerns, and put on the record some of the things that we have changed.

First of all, there has been a concern that some of the monitoring activities that we were calling for would produce government intrusion and stigmatization.  That we were calling for measures that would involve undue intrusion of government into the domain of ART.

That we would lead infertile patients and their children to be stigmatized by being monitored and registered, and that there was a concern that the studies that we were calling for might imply mandatory participation and create a de facto registry of children born with ART, though that was not our intent.

We have modified the document to expressly state that participation in all federally- funded studies should be fully voluntary as we had all along intended.  We removed the recommendation that the ART children be tracked through the first year following their birth, thus avoiding the inadvertent creation of a mandatory government registry of such children.

We have modified the document to note that the vast majority of our recommendations requesting additional information calls in fact for the publication of data that is already being collected by the CDC under the Wyden Act, but not made public.

And we have eliminated from this document our recommendation relating to the tracking of in vitro embryos produced during ART.  There has been some concern about sowing alarm and confusion about some of the terms having to do with the way that the data is reported, and the reporting of costs.

And I won't bore you with the details, but we have put in suitable modifying language to address those concerns.  A major concern was that our recommendations might lead to restrictions on access to assisted reproductive technologies, and the reasons that were given included the following.

That the recommendations for increasing reporting and monitoring might give rise to increased costs, which would then be passed on to patients due to this requirement of increased oversight. 

That people sensed that there were certain restrictions that we were recommending on the use of embryos in clinical and research contexts; and third, that there were restrictions on certain practices that were integral to ART, such as gamete and embryo donations, surrogacy and the like.

Partly, this, I think, rested on misunderstanding, and partly there were important issues to be discussed, and the new draft makes it expressly clear that our recommendation to increase the CDC's funding is aimed precisely at shifting the costs of any new oversight activities to the government rather than to the patients.

The draft makes it very clear that we are not calling for in vitro embryos as such to be treated as patients or human subjects of research, and the language that led some people to think otherwise, such as "child to be," or "future child," has been replaced with "children later born."

The concern throughout is to make sure that we safeguard the health and well- being of the children who are born as a result of these procedures, and that was always the intent.

If the language was confusing, that has now been eliminated, and the new version makes it clear that we are not calling for any kind of ban on gamete or embryo donation, surrogacy, the reimbursement for reasonable expenses incurred in the course of such practices, et cetera, et cetera.

So I think that we are very glad that these concerns have been called to our attention, even in places where we think they rested on some partial misunderstanding, and I would like to think that the new version of the recommendations addresses the concerns of the stakeholders, as well as the concerns of the Council members.

The goal for today is I think simple.  We were very close I think to an agreement on most of the things that are here.  The recommendations in the interim recommendations are in three parts:  (1) Recommendations for federal studies, data collection, reporting and monitoring, regarding the uses and effects of these technologies; (2) recommendations for professional - - for increased oversight by the professional societies and practitioners; and (3) recommendations for targeted legislative measures to defend the dignity of human procreation. Those are the three sections.  And my goal today, and I think we should be able to achieve it, is to try to reach the agreement on the gist of these provisions, leaving the line editing and refinements for later.

The rest of the document has been reedited, and will be sent to you shortly with a revised version of what we are talking about today, so that you will fairly soon be able to see the whole thing.

Given where we were on the stem cell report, and we didn't feel it was appropriate to burden you at this time with yet another hundred pages of document to be read carefully.  So that is coming next.

Any questions or comments on my opening remarks or on the procedure?  Frank, are you - - you looked like you were on your way to say something?  No?

PROF. FUKUYAMA:  I have several things to say, but not now.

CHAIRMAN KASS:  Okay.  A note has been passed to me, and I might as well read it, that Jim Wilson, who is unable to be here, did send in a note saying that he endorses this document as written.  So that is at least in the record and on the discussion.

Shall we begin and go section by section, and not necessarily article by article, and see whether people have comments in the large, first of all, about the particular items recommended.  And Janet Rowley, please.

DR. ROWLEY:  I was not able to be here at the October meeting, but I did raise a point that I think is very important in the September meeting, that I don't believe is really addressed by the draft that we have currently. 

I think it is very important that we recognize that the problems that we are facing, that this draft is trying to correct if you will, are due to two factors. 

One is the Congressional prohibition against funding any research related to embryos.  So there is much of the text that relates to the fact that the procedures, and changes in procedures, are often not as carefully documented as they would be in other kind of medical procedures, and it is strictly a result of the lack of appropriate and adequate funding.

So all of the research that is done is paid for by fees from patients to various clinics.  So this should be part of the preamble; that Congress has really forced many of these problems because of its prohibition.

The second problem that arises is that from the standpoint of patients this procedure is not covered by health insurance.  As a consequence some of the other aspects that we are concerned about, such as multiple pregnancies, which do not happen in other countries where they have appropriate funding of patient care, do happen here because the clinics are - - if you want to have a successful pregnancy, you put in multiple embryos, and this is recognized as a less than ideal medical procedure.

But it is strictly a result in this country of the way that we fund or do not fund health care for this particular medical problem.

CHAIRMAN KASS:  Any comment to that? 

PROF. MEILAENDER:  A question, just a question.

CHAIRMAN KASS:  Gil.

PROF. MEILAENDER:  Congress doesn't forbid all research on embryos does it?  It forbids research that involves destruction of embryos by federal funding of such research.  Am I not right about that?

We don't have any law forbidding research on embryos.  We have law prohibiting federal funding of research that destroys embryos.

CHAIRMAN KASS:  I think Janet's point would be something like this.  That attached to funding is very often the obligation for a certain kind of review, and that in the absence of a funding policy the government has lost - - in Janet's view, has lost something of its leverage to actually regulate the funded activity.

And I don't think she was saying that this is outlawed, that the activity itself is outlawed.

DR. ROWLEY:  Well, it's in - - I stand to be corrected by people who are more conversant with the specific details of the law.  But any sort of research trying to see whether Procedure A is more likely to give you viable embryos or viable embryos of higher quality, is inevitably going to lead to some of those embryos dying.

And that's because you are trying to see what you can do to improve it.  So I think that it is unrealistic to think that you can fund research on embryos that is focused on trying to improve conditions without as a necessary component of that being some research that would lead to the death of embryos.  And science is about comparing things.

CHAIRMAN KASS:  Robby.

PROF. GEORGE:  Janet, I just wanted to ask a question of clarification about your comment.  There were two parts to it.  The first had to do with what you take to be the implications of the prohibition on federal funding of embryo research or research that involves the destruction of embryos.

But as I understood your second comment, and this is what I wanted to be clear about, your second comment doesn't have to do with that?

DR. ROWLEY:  No.

PROF. GEORGE:  Your second comment is a more general criticism of the health care system in the United States, comparing it unfavorably, say, with the European systems.  That wouldn't have anything to do with whether embryo research is funded or not funded.

You are just saying that if we had a better and superior health care system overall that we would be relieved of such problems, which I would agree are very serious problems of, for example, multiple pregnancies, and the practice of implanting multiple embryos, with a view to having at least one survive and so forth. 

Just have I understood you correctly?  I am not here arguing with you.

DR. ROWLEY:  Right.  No, I think that is correct, and what I am saying is that these two factors play a central role in the problems that we are now trying to fix, but we are fixing it around the perimeter, and we are not dealing at all with some of the fundamental causes that lead to some of the concerns that members have.

And I think not to state this right up front is in my view a major deficiency of this particular document.

CHAIRMAN KASS:  Let me offer a comment in my own name, Janet.  I think - - I take your point, and I wouldn't deny the relevance of both of those considerations to the situation that we have. 

But I think on the first point that when similar comments were raised in the past, there were responses to say that there are all kinds of things that the government can and does regulate that it doesn't fund.

And indeed the Wyden Act to require the reporting is an Act that Congress was able to enact, even though it could not get past funding for the embryo research itself.

So it makes it more difficult, I grant, but the Government regulates lots of activities that it doesn't fund, and therefore one cannot simply say that the reason that this is an unregulated area is solely due or primarily due to that.

It is a factor, but I wouldn't share your interpretation that that is the cause.  And second even on the question of health insurance, the profession has in fact tried very hard to set guidelines to reduce the number of embryos that are transferred.

There is professional self- regulation, and we are in effect calling on the profession to do more of that.  You don't need a national health insurance to practice responsible medicine, and it might help to remove certain kinds of financial disincentives to practice responsible medicine.

But again I wouldn't say that that is the sole explanation for what we have here.  I am very happy to include the points in the analysis, but I am not sure that I would include them as determinatative, (a), and (b) in the recommendations, you will recall that we are trying to look for those things that we can recommend, notwithstanding certain kinds of unbridgeable differences amongst us.

DR. ROWLEY:  But I would like to come back to this, because I think that we have agreed that the government requires things that they don't fund, but I think so much of the text is that the technologies that are being used are experimental, and new technologies are put into place that are in one sense experimental.

And to decry that, and then to say that you can't put new technologies into place without having them thoughtfully and carefully evaluated, but we won't fund any of that evaluation on a larger scale, I think this puts us in the hypocritical state, which I suspect we would prefer not to be.

The second thing is that there is a great emphasis here on making - - and coming to my second point, making information available to patients about the success rate of clinics.

And to the extent that we tell clinics that it is important to use fewer embryos, their failure rate is going to go up.  This is going to reflect in the statistics. 

So the more responsible clinics that use fewer embryos will look worse in just the kinds of statistics that we are collecting.  And again I think that we have to recognize the forces that are driving all of this, and I think not to be honest about the forces is to undermine some of what we are trying to do.

CHAIRMAN KASS:  Mary Ann.

PROF. GLENDON:  Yes.  We are in the preamble, I gather, and the preamble states, or the introduction states that it would be premature at best to recommend dramatic legal or institutional changes.

Since a reference has been made to what is done in other countries and countries specifically with national health insurance, I thought that it would be interesting just to notice that I am reading from a January 11, 2004 summary of recent European legislation on this topic.

Many of these countries prohibit the freezing of embryos, limit a couple to 2 or 3 embryos, and some countries prohibit donations from third- parties, limit in vitro fertilization to heterosexual couples; prohibit genetic testing on embryos; proscribe cloning or experimentation on embryos.

And so it is worth noting that there are a number of countries that do not think it is premature to take more extensive measures than the very modest ones that have been recommended in our report.

CHAIRMAN KASS:  Frank.

PROF. FUKUYAMA:  I guess, Janet, I don't understand the objection, because the FDA regulates drugs.  You know, requires extremely expensive clinical trials that drive up the price of drugs, but the federal government does not fund the development of - - I mean, it may in some cases fund the development of new drugs, but it does not - - you know, you don't question the legitimacy of its regulation of private sector activities in drug development simply on the grounds of the level of funding, federal funding, for drug development.

So I don't really understand the two are necessarily related.  I mean, if there are serious safety considerations that are raised by private sector activities in this area, it seems to me that the federal government would have an interest in looking at that, regardless of whether it funds these activities itself.

DR. ROWLEY:  But, Frank - - I mean - - I don't think that is really relevant, because the drug companies after all are able to incorporate the cost of drug development in the cost of the drugs, and I am not aware that any drug company is on the street bankrupt at this point.

So I think that we are talking about activities which - - the research for which is funded by patients out of their discretionary funds, and I think it is a totally different matter. 

DR. FOSTER:  I was going to say the same thing.  In principle, what you say is correct.  But corporations have big funds for research.  You pay for it in the drug, but none of these people - - I mean, it is a very expensive thing to have in vitro fertilization, but nobody is getting rich out of that.

I mean, if you just look at the incomes, and the doctor's incomes and the nurses, and so forth, which are there, there are no - - as far as I know, there is nobody getting or has any excess surplus funds that you could do expensive laboratory or other research.

So I think that - - I agree with Janet that that doesn't - - that this is one of the rare times which I think that your comment doesn't apply, okay?

CHAIRMAN KASS:  Frank.

PROF. FUKUYAMA:  I mean, Congress just passed one of the biggest new entitlement bills for drug benefits precisely because the requirement for drug testing has driven up the cost of pre- drug development up in this country and people cannot afford it. 

So I just don't see in principle - - I mean, it is true that the structure of the ART industry is very different from that of the pharmaceutical industry, but part of the reason that you got this structure of gigantic corporations is precisely because of the regulatory burden that is placed on drug development by the FDA.

So, yeah, you are absolutely right.  It is going to drive up - - I mean, some of these things are going to drive up the cost of these kinds of treatments, and they will have to be borne out of the pockets of the people that want the treatment.

But again I just don't see how this is any different from private sector drug development.

DR. FOSTER:  I do want to say also without being - - I love the drug companies.  They are making wonderful new drugs, but I don't have the latest figures, but I believe the evidence is pretty overwhelming that they spent more money on advertising and doctors in luxurious parties than they do on research and development.

So, I mean, I think that is a very - - it is not fair to say that the cost of the drugs are solely because of regulation for safety on the FDA.  I mean, if you look at these budgets, I mean, they are obscene about some of the things that are done at scientific meetings and so forth.

I mean, that is probably irrelevant, but I had to say that because it gets my spleen up; that when everybody says that because of the drugs the FDA is the cause of this.  I think we ought to be very thankful that we have an FDA that is trying to carefully look over these drugs, and particularly the second level drugs and so forth that go on.

I happened to hear the Commissioner talk this week at this meeting in Texas, and he points out and defends even the approval of second - - you know, "me- too" drugs, and drives the costs down, and so it probably - - you know, I don't know much about the FDA, but I think that we shouldn't blame them for these costs exclusively.

PROF. GEORGE:  Dan, you have whetted my appetite.  What are these obscene things that happen at scientific meetings?

CHAIRMAN KASS:  No, let's - -

DR. FOSTER:  I should not use that term.  The obscenity is gluttony of food and drink, that's all, and nothing to do with anything immoral, okay?  Please do not saddle me with that.

CHAIRMAN KASS:  Let me try to resolve this.  We will certainly take Janet's comments into account in the new draft.  One word on the costs, and the cost was an issue already raised, and we have indicated at least with respect to the call for additional federal activity that the funds ought to be provided as they are now provided to the CDC for any additional activity that the CDC would undertake.

So that this would be an attempt not to pass those costs on, or at least that is our - - we are cognizant of that fact.  Let's go from the preamble actually to the particular recommendations and in Section 1.

Welcome to Mike Gazzaniga, who is happily down here where the temperature is only 30 degrees instead of minus 30.  Oh, and Charles, welcome to Charles Krauthammer.  Sorry. 

Section 1, beginning on page 3, we are just beginning to review the particular recommendations on the federal studies.  And since we could go one by one, but let me - - and since I think that this is relatively okay, why don't I simply put the whole of the materials from page 3 through page 10; the federally- funded longitudinal study on the health and development implications of ARTs on children.

And we have had very good conversations with the people designing the National Children's Study, and we are hopeful that they will be willing to include this as part of their study.

To undertake federally- funded studies on the impacts of ARTs on women, on the uses and effects of reproductive genetic technologies; strengthen and augment the Fertility Clinic Success Rate and Certification Act with specific provisions on reporting requirements.

And on enhancing patient protection and implementation.  These have been streamlined and changed in ways that I already indicated.  Are there questions or comments on any of these particular items?  Gil.

PROF. MEILAENDER:  My comment is with respect to something on pages 6 and 7.  It is under the enhanced reporting requirements, (b) I guess it is, risks and side effects.

I would like to see us restore a sentence that was in an earlier draft, but is not there any longer.  I don't know whether the rest of you will think it is worth it.  But I preface this by saying that sometimes when you bend over backwards to be accommodating, you simply get kicked.

And that seems to me to be happening here.  I mean, we have before us a news release from RESOLVE about what we are supposedly doing today that is inaccurate in almost every respect. 

And this was one of the stakeholders that we were worried about.  What I would like to see us do is add at the end of that paragraph that goes over on to page 7 a sentence that simply says this is taken from the previous draft.  ART clinics should be asked to provide data on the incidents of adverse effects on women undergoing treatment, as well as on the health and development of children born using ART at least through the first year of life.

I myself don't understand why anyone wouldn't think that was useful information, and that one would like to know.  Remember that all we are doing is asking for information to be gathered that might be helpful in determining what regulation, if any, would be needed or wise to advise.

It seems to me that this sort of information would clearly be useful, and would be worth knowing.  I don't understand why it dropped out, and I myself would like to see it restored.

CHAIRMAN KASS:  Carter, I may need some help on this, but I think I can understand why it is absent.  First of all the clinics do not follow these children once pregnancy has begun.  They are turned over to the obstetricians, and then to the pediatricians.

Second, in order to do that, you would have to have a de facto registry of children born with ART, and there is a great deal of interest both in the patient groups and in the practitioners, to protect the privacy of the participants.

We thought that we might in fact get the kind of information we were interested in from a longitudinal study in which people are tracked not just through the first year of life, but as long as the study continues, and tracked prospectively such that one would simply happen to know that some of the children in the study had this origin.

And that all of the participants would be volunteers, and we would get the information without having to violate these particularly important principles and concerns, both of the patient groups and of the practitioners.  Carter, have I got that right? 

MR. SNEAD:  Yes, I think that is a fair characterization.

CHAIRMAN KASS:  Carter Snead, who is our general counsel, has been the major - - in fact, Carter, why don't you take a seat here, because we might need you in addition.   

MR. SNEAD:  Yes, Leon, I think those were - - that was a fair characterization of the concerns that were raised, both the logistical difficulties of gathering that information, and requiring coordination with pediatricians and so forth. There is not right now a continuity between the doctors that - - you know, the reproductive endocrinologists, the obstetricians, and then later, pediatricians, that would have to be created.

And then secondly there were concerns about stigmatization of these children through the creation of a de facto registry as you outlined.  I think that is a fair characterization. We thought that we would get the same sort of information through the longitudinal study.

And then additionally - - and one thing to add about the longitudinal study.  The National Children's Study, if they were to accept our offer to include this information in their project that they are going forward with, they release their data at certain milestones, such that you wouldn't have to wait for 21 years to get the relevant information.

And so there would be sort of a rolling reporting of the results that they would get.  So basically to accommodate the concerns that were raised, and with the idea that the same information could be gathered through other mechanisms, that's why the document was changed the way that it was.

CHAIRMAN KASS:  Other comments about these original

- - Gil, do you want to - -

PROF. MEILAENDER:  I would just put on the record that that does not seem to me to be a sufficiently weighty reason to eliminate it.  It does seem to me to be information that would be useful to have.

I think the registry language is bogus, and there are plenty of ways to protect confidentiality in our world.  And I can't see much hope for any future regulatory agency keeping close watch on these matters. 

If a body like ours that simply is thinking about what information it might be useful to have in order to know whether there should be such an agency, or what it might regulate, already goes belly up at the first sign of pressure. 

So it seems to me that it is useful information and that it would be good to have.

CHAIRMAN KASS:  On this very point, Robby.

PROF. GEORGE:  Yes, I wonder if the staff has looked into it, or if Mary Ann just happens to know, how other jurisdictions - - European countries, Japan - - have dealt with trying to honor both of these concerns, the one that Gil quite legitimately raises, and the concern about privacy and so forth.

Perhaps there are models that would be helpful to us.  Do you know?

MR. SNEAD:  As far as the jurisdictions that have the most comprehensive approaches to monitoring and oversight of these reproductive technologies, my recollection is, if it is correct, is that there is no jurisdiction that provides for oversight up to a certain - - beyond the stage of birth.

So as far as I know, there are no models that would provide useful examples for how to solve the logistical problems of tracking these children and their families.

And most of the registries that are being created abroad, my understanding is that in France and maybe in Belgium, there are sort of federally- sponsored efforts to track these individuals, and I would have to look more closely at how they go about doing that.

PROF. GEORGE:  Do you know anything about whether privacy concerns have been taken into account?

MR. SNEAD:  I imagine that they have been.  I met with our counterparts at the HFEA in Britain in August, and that seemed to be a concern that was very - - that was foremost in their minds was safeguarding privacy.

So I think that they had done that in a way that is satisfactory.  I can't speak to the specific mechanisms that they used though.

PROF. GEORGE:  Well, I would like to request that the staff look into this and perhaps we can satisfy everyone here.

CHAIRMAN KASS:  Okay.  Still on this same point, or are we going somewhere else?  Is it on the issue that we were just discussing?  Mary Ann, is it still on this point?

PROF. GLENDON:  Yes. 

CHAIRMAN KASS:  Please. 

PROF. GLENDON:  I just think it is worth emphasizing how modest the recommendations in this section are.  Nobody is talking about government regulation of a practically unregulated industry.  One is only talking about information so that there can be informed public deliberation of some of these issues, the kind of deliberation that we have in a democracy.

I think that I am just a little skeptical about talk about undue government intrusion, or privacy concerns, when all that is being sought here is information and letting the sun shine into an industry that apparently is bent on keeping its activities from public surveillance.

CHAIRMAN KASS:  Comments still on this?  Mike, do you want to go somewhere else?

DR. GAZZANIGA:  Well, it is related.

CHAIRMAN KASS:  Please.

DR. GAZZANIGA:  I am continuing to read this section and to be able to think about it, and it really comes down to what we are saying, is that we are trying to recommend that epidemiological studies be carried out in IVF.  Why don't we just say that?

Federally- funded, and we would recommend that federally- funded epidemiological studies be carried out on IVF, period, and not try to play the game of what all that means.

There are epidemiologists who know how to do this, and they do it all the time, and for us to try to prescribe these various this and thats is probably not necessary, and I don't even know that it is particularly informed by the subtle science of epidemiology.

So - - I mean, what the intention is, is simply to carry out that sort of activity, but let the sun shine in as Mary Ann says, and there are procedures for - - well- established procedures for doing that, and I recommend that we just recommend that.

CHAIRMAN KASS:  Rebecca.

PROF. DRESSER:  Well, I think we are writing this document not just for researchers, and so I think it is worthwhile talking about what the kind of information is that we would like to see to the ordinary person.

I mean, if you just say do epidemiological studies, the ordinary person won't be able to understand that, and I guess I want to second the consumer protection value of this information.

This kind of study would enable people who have children this way to know if there are certain medical problems that crop up more often, so that the pediatrician needs to be looking for them.

This really could promote the health of these children, and so it seems to me that consumer groups should welcome a call to produce more of this information just so that their constituencies can make better informed decisions, and they are usually people who are very concerned about the well- being of their children.

And this kind of information would enhance that ability to show concern for their children.

CHAIRMAN KASS:  Janet.

DR. ROWLEY:  Well, I noticed that Kathy Hudson is here, and I wonder with regard to the question of what other countries do, because I am under the impression that they are some large studies in this matter, whether Kathy could answer or has any information, or - -

CHAIRMAN KASS:  Kathy, would you like to respond, if you wish.

DR. HUDSON:  With respect to the question of post- birth surveillance of health of ART children, in other countries I think the situation is quite different, where there are national health records in many countries, and national birth records in many countries, that can be linked.

So you can do studies, albeit retrospectively, of large cohorts of children because of the existence of these records.  So I think where we see the best data is in fact in countries where you have that kind of record system, which of course we don't have in the United States.  Was there another - -

DR. ROWLEY:  Well, the question is whether there are any results or whether these studies have a time in which they are going to do the analysis and publish them?

DR. HUDSON:  The European Society of Human Reproduction and Embryology has been doing a very large prospective trial looking at children's health from ART.

And they are now following kids up to about seven.  I think they have reported data on the health of children out to about seven.  I think the existence of that data doesn't negate the need for additional research in the United States, because techniques do vary.

DR. ROWLEY:  Thank you.

CHAIRMAN KASS:  Thank you very much.  Dan.

DR. FOSTER:  Michael, I thought that it was very attractive from this standpoint to try to bond in on the study that is going to already be done.  I mean, that you are going to follow these, and so it seems to me that the modesty of this is also very practical, and the information that we really want to know would come out, and particularly since they are going to have interim reports.

I mean, just look at the Framingham Study and things like that.  I mean, we really need to know whether if you take a cell out for genetic diagnosis and so forth whether that does anything or not.

I think that everybody would want to know that, and so I was really quite enthusiastic about not coming up with some - - to say somebody else to do an epidemiologic study, and let's say an agency such as the CDC or something.

I like the idea of trying to just add on - - because it is a monumental thing to follow a hundred- thousand kids.  I mean, you know, people drop out of these things all the time, and so I thought that this was a great idea myself.

DR. GAZZANIGA:  Well, let me just comment on that.  I have no problem that the epidemiological analysis goes on within that study.  That study as you know has not been funded.

And they are looking to tack this on to try to get it funded and there are inherent problems with these studies because of the drop out and because you start to dilute the number of factors that you are looking at, and then you can't really say statistically about any of them, et cetera, et cetera, et cetera.

So I think that it is fine in the sense - - I mean, in the sense that it sounds right, but in some sense just to recommend funding of IVF might allow it to go forward when maybe that mammoth thing won't go forward.

So you might get locked up in getting what you want to get done here by completely attaching it to that study.  That is just a very practical point.  But that is what we are talking about. 

We are talking about getting it done somehow, and I think just saying it is sufficient.  I mean, then we don't have to get entangled in all these subtleties.

DR. FOSTER:  Well, I heard what you just said about maybe this would enhance, but maybe the sentence that one would add here would be something like that should there be a failure of funding of the child health study or whatever it is called that we would recommend an independent study of the children be funded because this is such a critical issue.  Maybe just a sentence like that added would be helpful.

CHAIRMAN KASS:  Also, let me just say quickly, Mike, that one could preface this with the generic comment that you make, but the particular things that have here been identified are in fact and do grow out of the analysis that we haven't recirculated at this time.

But that we have identified different kinds of areas for an epidemiological study, and we have also talked about the already existing reporting requirements and suggested that there might be some additional things that could be done to augment the publication of data already collected.

So I do think since there are various possible target audiences for this that there is a certain amount of specificity is, I think, helpful.  But I am prepared to - - well, these are the kinds of information that we are somehow specifying here.

If we are going on too long about it,and you think it could be streamlined, we could certainly do that.  Anything on the particular concrete substantive things in that first section?

DR. ROWLEY:  As a point of information, Carter, I have been told by individuals with whom I have been discussing this matter that there is in fact a federal website that is devoted to information about ART, and it is my impression that this is the only federally funded site on any medical procedure.

MR. SNEAD:  I think what you are referring to, and you can correct me if I am wrong, is the CDC's ART surveillance website, which -- is a web publication of the document that also comes out in hard copy that is basically required by the Wyden Act, to outline the success rates and various points of analysis.  Is that what you are referring to?

DR. ROWLEY:  I assume so, since this is information that I have gotten from discussions with others.  We didn't go into great detail about this.

MR. SNEAD:  Right.

DR. ROWLEY:  But it is pointed out that there is no other federally- funded website about any medical procedure. 

MR. SNEAD:  That's interesting.  I was not aware of that, that there were no other federally- funded websites.  I know that the CDC has other websites relating to other medical concerns, but I don't know how that bears on your comment.

But that would be news to me if that were the only federally funded website that relates to a particular procedure. 

CHAIRMAN KASS:  Shall we proceed to the second section?  Robby.

PROF. GEORGE:  One more, Leon, on that question of the possibility of tracking the numbers of embryos that are created, their use and disposition.  My impression is that it is actually very difficult to get reliable information about just the sheer numbers of embryos that are created in the industry, and how they are used, and their final disposition.

If that is true, is there any proposal short of the one that was in the original draft for enabling that to be done?  Or if we don't propose anything here, will it just be continued ignorance about the facts?

CHAIRMAN KASS:  We made a decision simply to remove that section.  There has recently been a study, the RAND study, which has disclosed the numbers.  It would be possible to make a request to produce aggregated data from the various clinics without identifying which clinics.

I mean, the clinics are rightly concerned that publication of such data with their names attached to it would in fact enter into the political turmoil about abortion politics and the like, and they want to protect the privacy of what they do.

There is a case to be made that the Nation as a whole might like to know the answer to just simply the quantitative data.  But we recently had a study which to the best of people's knowledge, indicated there were roughly 400,000 embryos in cryopreservation.

And I guess the question is what difference would it make if we commissioned a study which produced the number of 600,000, or 300,000, or 1 million?

It seems to me the number - - we know that there are lots, and since this is not - - since we don't have a policy here to recommend on what should be done there, it seemed to be to call for that kind of data collection at this point, knowing that the number is very large already, seemed gratuitous, and off the main point.

If there is strong feeling that this should be restored, I am not unhappy to restore it, but it didn't seem to me to be essential to what we were talking about here. 

PROF. GEORGE:  Well, if we could get the information another way, I would be very open to that, but I think that the information is potentially relevant to public policy mix and the kinds of people that we are attempting to serve. 

I think it is.  I mean, as we go forward just being able to compare what goes on here with what goes on in other jurisdictions that have other sorts of regulatory schemes or have regulatory schemes at all, I think would be potentially at least very valuable.

CHAIRMAN KASS:  It certainly would not hurt anybody to know the answer.  But let me simply ask, is there anybody who would object if there were simply a restoration of some kind of request for information on the number of embryos created and stored? 

Do we regard that as an important piece of information that people want to know in this area or not?  Yes, no, maybe?  How many think that this is information worthy to be had and that we should restore something on this?

(A show of hands.)

CHAIRMAN KASS:  How many think otherwise?

(A show of hands.)

CHAIRMAN KASS:  We will think about it.  I mean, there was a certain - - and we will talk to the individuals, but there was a certain sense that these recommendations were to be as much as possible the recommendations that were rested on those things about which we could agree, and part of the thing is to show that people have differences of opinion on some of these matters, and find a basis nevertheless to speak in common on things that are dear to us.

I won't discuss - - I think we have noted the people who have reservations about this.  We will pursue that, and if - - and we will reach some resolution on that, and you will be informed rather than try to fight it out here.  Is that agreeable?  Janet.

DR. ROWLEY:  It is not on this point, but it is on page 8 and 9.  Are we still on those pages?

CHAIRMAN KASS:  Fine.  Yes, we are still in this section.  I am going to try to budget our time to make sure that we don't lose out on the sections that might take us longer than this.  But, please, Janet.

DR. ROWLEY:  Well, again, in discussions with people more knowledgeable than I, it has been pointed out for Section E, the adjunct technologies, and our concern about ICSI, that in fact about 5 percent of apparently normal sperm failed to fertilize an oocyte.

And at least right now, given the fact that there is no funding to understand these problems, we can't - - I mean, the individuals involved in this can't distinguish the normal from those that have various other things that can be identified.

So, you see, we have talked here and commented about the fact that ICSI is used in individuals, even those who do not suffer from male infertility factor, and again with the pressure to have positive results, both from the standpoint of patients for whom this is a painful - - or for women for whom this is - - the whole process is a painful procedure, they use ICSI to increase the likelihood that you will actually get some embryos from the procedure for the women.

So we are saying that the industry is being irresponsible by using ICSI when they don't need it, but the matter of fact is that you don't know for those who are the 5 percent who they are, and therefore, many clinics in order to make certain that there are some embryos that are developed, do ICSI when it may not be needed.

But, you see, that doesn't come through in the text that is stated here.  So I think that we should be a little bit more - - either indicate that there is this 5 percent where it would be unsuccessful, or maybe modify the text here not to be quite so critical as we are of this procedure. 

CHAIRMAN KASS:  If there is an implied criticism, the implication will be removed, and the request is simply for the reporting of the data and the indications, and if there are additional indications, then of course we should note that.  That is a good point, and we will fix that.

Look, I am mindful of the clock, and let me do something slightly out of order.  I suspect that we need more time to discuss Section 3 than Section 2, Section 2 being recommendations to the professional societies and practitioners.

And let me simply go out of order and do Section 2 last to make sure that we don't wind up at 5 minutes to 12:00 with only 20 minutes or so to do Section 3.  So, we will do Section 2 last.

Let's turn to the targeted legislative measures, pages 13 through to the end.  I repeat that these have been pruned, and things that were contested last time have been removed, and certain sorts of other difficulties ironed out. 

And maybe we should keep our attention to the specific proposals first, and worry about the fine tuning of the rationale, and the discussion later.  Page 16, the transfer, proscribe the transfer for - - by the way, let me say just - - and in this document I apologize, but it doesn't have this point that was made the last time in it.

And these suggested targeted legislative measures were meant to be temporary.  It is indicated in passing that that is the case, but we don't say that there should be a fixed time on it, and that is for review, and that was one of those suggestions made in the Council meeting last time and that will be added to the final version.  So these we are targeted legislative measures of a temporary sort, at least until additional discussion proceeds.

Then to page 16, proscribe the transfer for any purpose of any human embryo into the body of any member of a non- human species, and to prohibit the production of a hybrid human- animal embryo by fertilization of human egg or animal sperm, or an animal egg by human sperm. 

These are the two things that survived.  There were more things in the previous version.  Dissents, objections, comments?  The Dean from Dartmouth.

DR. GAZZANIGA:  Oh, geez.  It is cold up there.

CHAIRMAN KASS:  It is very cold.

DR. GAZZANIGA:  You know, it is all sort of - - you know, this flows from the dignity of human procreation and all of that, and I keep thinking of G.K. Chesterton's remark to his son as he went off to college.

He said that with respect to sex, son, it is a ridiculous posture, and I always get confused about where we launch from here.  So if you look at - - I mean, what everybody wants is a child out of any deal, right?  A beautiful child.

And that normally occurs in 98 percent of the time through mechanisms that we all know about, and love and respect.  But frequently it occurs through going to a lawyer's office, and figuring out how to pay money to go adopt a child.

And I don't know.  Maybe biomedicine is going to come up with a mechanism where a husband and a wife can fertilize an egg, and the woman can't have it implanted because of certain medical problems, and you can think of a cow as a big tissue culture to allow the baby to grow. 

And what happens is that when the baby is ready for birth the family seizes on the baby with all the love of any parent and life goes on.  So, you know, we take - - a lot of these things that have been put in there have been set up with this crazy humanzee notion and that sort of thing.

And really I think, if we start fiddling around with this language, that we may be stumbling upon possible future biomedical advances don't seem very normal after a while. 

So I am concerned with when we start introducing language like the first item there. 

CHAIRMAN KASS:  Comments?  Rebecca.

PROF. DRESSER:  I like the way this is set up because it is a temporary moratorium and it just shifts the burden.  In a sense, it says all right, if you come up with something that seems to be covered by this within the time frame of the operation, then you have to make your case and explain why - - you know, certainly it is safe, and needed, and other alternatives don't sufficiently meet the need, and that certainly that practice would be something that ought to be publicly discussed before it went forward.

So I do think that the posture of this, that it sets up, the procedural posture, leaves room for situations where a new technique might develop that does seem to fall under this, and might have a reasonable rationale, and there is still the opportunity to present the case, and certainly the research on that sort of a procedure would probably last longer than these provisions, in terms of effect.

You know, they would go out of operation and then there would be a new discussion about whether a more specific prohibition or provision were needed.  So I think the way that it is constructed, it is sufficient to handle innovations like that, or other things.

CHAIRMAN KASS:  Are there comments on this one?  Janet.

DR. ROWLEY:  Yeah.  I assume in the staff's discussion with representatives of the organizations that have a direct interest in this, and that these were items that did pass their scrutiny and have been retained.

In my discussions with other individuals, they are concerned that it appears to paint the ART community in a less than ethical light by implying that these things are something that the scientists in the ART community are preparing to do, and so we have heard certain discussions about some things that have been done in other countries, but at least as far as those practitioners in the States, they have real concerns about even including these things because in their view this is not something that they are planning to do.

DR. KRAUTHAMMER:  We could take are of that by adding the phrase, "without prejudice" and "without implication," and that would take care of that, I think.

DR. ROWLEY:  But if that is the case, then why do it at all?

DR. KRAUTHAMMER:  Because - - not because some people are doing it today, but because it is something that we believe is abhorrent and ought to be at least not permitted until people make the case otherwise.  It seems rather simple.

CHAIRMAN KASS:  In fact, the argument that we - - I am not sure, Janet, that it would be fair to say that everything that survives here has passed the scrutiny and claimed the approval of the people with whom we have consulted, that is not our task.

And our task is to learn from them, where we have done things that we ourselves would recognize as unreasonable, or be educated by them about things that would place undue burdens on their practice.

I don't think that there is any implication here that the members of this profession are unethical or unscrupulous.  It is an expression of the community's support at the moment to try to set certain boundaries, and one of the ways in which the professionals could in fact show that they are not under suspicion is to endorse these provisions.

I mean, these are exactly the sorts of things that the responsible practitioners ought to be able to say and be offered - - this was a suggestion that we made in conversation with representatives from ASRM.  We have a stake, we would suggest, in making sure that everybody understands that the profession has the highest ethical standards, and doesn't mean to ride roughshod over the boundaries that the community has established.

So we are trying to do those sorts of things for which they might worry about Congress doing anything because they don't like that.  But we have tried to devise those kinds of very modest things that ought to appeal to just about everybody, other than those people who don't give a damn.

So there is no imputation that there is anything irresponsible about practitioners or their society here.  Paul McHugh.

DR. MCHUGH:  Well, I may be saying something at once obvious, but in relationship to this first thing, I have two reasons for wanting to have it included.   One of them is simply the "ugh" factor. 

I don't think that I can speak to the ordinary person in America and say that we think that babies should come from cows very simply, and so therefore the burden would be for the scientists to say that this might be okay.

But I have a more practical concern and reason for wanting to see this.  I believe that it is not outside of anyone's imagination that the process of putting an embryo into an animal to let it proceed for a while would soon become a process searching not for a live baby for these folk looking for a baby, but for ultimately the harvesting of those embryos for their bodily parts; their kidneys, their hearts, and the like.  And I find that repugnant, too.

CHAIRMAN KASS:  Frank, and then Dan. 

PROF. FUKUYAMA:  Well, this just follows on the last couple of comments, and this is actually, Mike, more of a response to your written comments than to what you just said, but I don't think that what you are defending is necessarily the dignity of - - you made the comment that human reproduction is not all that different from the mammalian reproduction more generally. 

But I think what is being - - you know, you can at least say that each species has its own reproductive rules, and evolution has designed them to be an integrated whole.  So that a baboon presumably will not do very well if implanted, or as a baboon won't do well if put in a human uterus. 

And I would think that there are huge medical risks if you create an embryo that has got, for example, animal - - you know, mitochondrial DNA, and if you - - and I am sure that there are all sorts of things in the developmental process that go on within a uterus that are specific to a human uterus.

And so again this just reinforces the point that there is a huge burden of proof that needs to be met before you start violating what evolution seems to have designed as this fairly integrated reproductive processes.

CHAIRMAN KASS:  Dan Foster.

DR. FOSTER:  I just want to make a small point in response to Janet's.  I don't know who you have been talking to, but I am not very sympathetic to the view that this might be in some sense a judgment on the ethical procedures.  Let me just turn to the scientific community already, and the protection of human resources.

The scientific community found it extraordinarily abhorrent that some of our greatest universities, and some of our very best genetic people about deaths that have occurred doing things that nobody thought should have been done.

I am not very moved by somebody who is in the ART saying, well, you are impugning our integrity when already we know that in the greatest of our universities, and in the whole scientific community - - well, I can't say whole, I don't know that.

But I can tell you that universally condemned - - and I not going to mention the names - - the things that were done here.  So I don't think we ought to be too worried about somebody's concern about moral things when we know that the very best scientists that we thought - - well, I don't want to get started on this, but we need to assume that because we can do certain things that they are going to be done, and not just in rogue private laboratories.  But in the university laboratories of the highest things.

So I am very much in favor of saying let's don't do crazy things.  I mean, I don't know what cow uteruses do, but I know that some people think that prion disease, for example, may in some sense be contagious. We know that cattle carry E. coli, 25% of which are type O157 H7 that may be fatal from HUS ( hemolytic uremic syndrome) from eating insufficiently cooked hamburger. So it is a modest thing to say ' lets don't do crazy things that we can do when we don't need to do them' and I feel pretty strongly about that.

And as I said, I don't want to just hear somebody say, well, we are impugning somebody.  We have to be very careful about what we do.

CHAIRMAN KASS:  Anything further on these?  Do you want to move on?  Let me make a procedural observation, because Mike - - and I don't know that you would regard all of these answers as a satisfactory response to you, and I don't want to put you on the spot. 

But I am interested in going through all of the comments, and if there remain - - our aspiration was to produce something that we could all agree to, but if it turns out that that can't be done, then we will be left afterwards with trying to sort this out.

And we will figure out a way to handle this either by removal or perhaps by allowing the expression of individual dissent in a very strong way on whatever it is.

This is to take the burden off of Mike from saying here and now, okay, you guys have persuaded me.  I doubt that is the case, and I would like to at least see where we are on some of the rest.  Is that okay, Mike? 

DR. GAZZANIGA:  That is very kind of you, Leon, and you are exactly right.

CHAIRMAN KASS:  Okay.  Let's move to the second.  This language has been changed to make it unambiguous; to prohibit the transfer of a human embryo produced ex vivo to a woman's uterus for any purpose other than to attempt to produce a live- born child. 

And the grounds of this have been laid out in the paragraph before, but what we are concerned about is the correlate to the previous one.  If human embryos go anywhere, they go into human uteruses, and if they go into uteruses, they go into human uteruses, and what goes into a human uterus goes only for the purpose of producing or trying to produce a child. 

This I think the last time around had not even a whimper of dissent.   Are we all right? 

DR. ROWLEY:  Just as a point of clarification, I assume that this language doesn't really prohibit the use of PGD to select for an embryo that might be appropriate for some other purpose, because that embryo is selected in general to go to full- term.  So that is not covered in this.

CHAIRMAN KASS:  This solely has to do with for what purpose may you - - the previous language was to initiate a pregnancy, and that was found to be - - it was obscure and it raised all kinds of worries that were unnecessary, and so this is in effect to start a pregnancy by the transfer of a human embryo conceived or produced ex vivo for any purpose other than to yield a child. 

It says nothing about what is done with embryos outside that don't get transferred. 

DR. ROWLEY:  Or before the selection of the embryo being transferred.

CHAIRMAN KASS:  It says nothing about that at all.  This next provision was one that caused a lot of trouble, but I think we have found with one exception, and I can call attention to the problem in the language now, but the one about children.

I think we have found a way to express this that was satisfactory to the vocal disputants of the last occasion, with the important exception that the presence of the word "and" on the top of page 18 seems to imply that in order for something to be ruled out it has to be guilty of all of those three things.  That doesn't really make sense.  I think the language should be "or" and the reason that we have listed it this way is so that the footnote could operationally define in one footnote exactly what it is that is meant. 

Prohibitive attempts to conceive a child, footnote, and by definition that means to create ex vivo an embryo of this sort with the intent to transfer to a woman's body to initiate a pregnancy.  Prohibit attempts to conceive a child by any means other than the union of egg and sperm by using gametes obtained from a human fetus, or derived from human embryonic stem cells, or by fusing blastomers from two or more embryos.  These were under discussion the last time.  Michael.

PROF. SANDEL:  Well, I think removing the "and" so that it is clear that we are not asking Congress to prohibit some bizarre compound activity that would never arise is a good thing.

But I am not sure that "or" removes the ambiguity altogether, because it could be read as proposing that Congress prohibit one or another of these three things.

So what I would urge is that we remove the ambiguity by simply adopting and by repeating the verb clause for each of the three bullet points as we have done with all of the others, this may seem like a semantic distinction, but I think that it is important for reasons that we could pursue, and that came up last time, but simply say prohibit attempts to conceive a child by any means other than the union of egg and sperm, with the asterisk and the footnote.

And then repeat that phrase in each of the two other proposed prohibited activities with the same asterisk and with the same footnote. 

CHAIRMAN KASS:  I don't see any problem with doing that.  We were - - quite frankly, this was one of these places where footnoting and simply the questions of the mechanics of getting footnotes on the page, and repeating footnotes, suddenly produced a way that you could probably do this with one footnote, and the thing was restructured. 

But we are perfectly happy to restore the less ambiguous way and have the same footnote referred to three times or have it three separate times.  It is not a problem.  Are we okay on this?  Difficulties?

(No response.)

CHAIRMAN KASS:  We come to the fourth set of recommendations, pages 18 and 19, and here once again this may be contested.  This recommendation, these recommendations, do not say anything about the licitness or illicitness of embryo research as such.  But even the people who would be or who would prefer that there be no embryo experimentation, but recognizing that it goes on, are willing to join with others.

In fact, the minority position in the cloning report did call for regulation of this, and setting an upper boundary, that there should be some kind of upper limit on the age of embryos available for research, at least at the present time.

And that this is an attempt to suggest the prohibition of the use or preservation of those embryos that are already being used solely for the purposes of research beyond a designated stage of embryonic development, and we left it to the Congress to find its date.

We suggested the range, and then as a result of a long discussion the last time, and what was left of the commercial matter was to prohibit the buying and selling of human embryos.  The gametes part of that as you will recall was in there last time and is not at the present time. 

DR. KRAUTHAMMER:  Leon, I think that I might want to include the range that we have considered, the 10 to 14 days, in the body of it. 

CHAIRMAN KASS:  In the body of the recommendation?

DR. KRAUTHAMMER:  Yes.  I am a little wary about leaving it entirely up on the air, because it would allow - - I mean, if we are assuming that this will go to Congress, and there might be pressure to allow higher upper limits, and I think most of us, or I think all of us would agree that the upper limit ought to be within this range.

And I think it would be helpful to Congress to have that as a guideline.

CHAIRMAN KASS:  As a guide posture, yes.  Any objections if we put that into the text?  I mean, they are obviously free to ignore all of this, or free to ignore that, and once again this is for the time being recommendation, and even our representatives from BIO said that they would for the time being favor such an upper limit if I am not mis- remembering that conversation.

We might even have a fair amount of public support on this as well.  Are there any objections on any of this?

(No response.)

CHAIRMAN KASS:  We are left with the patenting matter, and I think that people probably know that - - if I can get my cheat sheet here, that the House - - that this recommendation might be rendered moot by developments in the current session of Congress.  The House of Representatives has included an amendment to the Commerce, Justice, State Appropriations Bill for Fiscal Year 2004 that would preclude the Patent Office from issuing a patent, "On claims directed to or encompassing a human organism."

And the Patent Office has supported this amendment, and the House - - the Senate and House conferees have agreed to include this amendment with some explanatory language in the final version of the bill, but the Senate has yet to vote on the bill, but may do so as early as next week.

If that in fact happens, we can simply delete this provision as being rendered moot.  Michael.

PROF. SANDEL:  Is there any good reason that we have for using the word, the phrase, human embryos or fetuses, instead of the word that is in the legislation that you just read, human organism?

CHAIRMAN KASS:  I see no reason not to even prefer it; to encompassing human organisms at any stage of development I think would be - -

PROF. MEILAENDER:  I don't see any reason not to prefer it.  I think the reason that it is here is that it came immediately under the section on respect for early stages of human life. 

And that is probably the reason, and it would need to be clear that it was not a part of that section if the language were changed. 

DR. KRAUTHAMMER:  What does organism add that embryo or fetus would not?  I mean, what are we losing by using embryo and fetus?

PROF. SANDEL:  I don't know the legislative history that led them to adopt organism.  I would be interested to know and to consider that before we decide what language makes the most sense to us.

CHAIRMAN KASS:  Charles.

DR. KRAUTHAMMER:  If it is a question of just matching the language, then I have no objection.  I was just wondering whether there is a substantive difference.  I don't really see any other than organism might mean a full human, which would be an anti- slavery provision, which would be nice, but it is 160 years a little bit late.

So I had no objection if it is just a matter of procedure, but I would be interested if there is an actual difference here. 

CHAIRMAN KASS:  Carter, please. 

MR. SNEAD:  I was just going to add a point of information on the legislative history to speak to the evolution of the language in that particular provision.

In the version that has been tentatively approved by the conferees, they have included in the language now - - they have agreed in principle to include language, a colloquy between two members of the House of Representatives to clarify, because there was some question about what the word organism referred to, they have now included a col