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Thursday, January 15, 2004

Session 1: Stem Cells: Council's Report to the President

Release of Monitoring Stem Cell Research: A Report of the President’s Council on Bioethics

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 Gómez-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.


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?


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. FRIEDMAN:  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.)

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