Ritz-Carlton Hotel
22nd Street, N.W.
Washington, D.C. 20037
Thursday, July 11, 2002
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.LM.
Harvard University
Alfonso Gómez-Lobo,
Dr.
phil.
Georgetown University
William B. Hurlbut, M.D.
Stanford University
Charles Krauthammer, M.D.
Syndicated Columnist
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
TABLE OF CONTENTS
Session 1:
Human Cloning (Final): Council's Report to
the President
Introduction, Chairman Kass
Personal Comments by Council Members
Press Availability
Session 2:
Regulation 4: Patentability of Human Organisms
Session 3:
Stem Cells 4: NIH Funding of Stem Cell Research
(Implementation)
Dr. Wendy Baldwin, Office of Extramural Research
National Institutes of Health
Session 4:
Enhancement 2: Potential for Genetic Enhancements
in Sports
Dr. Ted Friedmann, University of California-San Diego, and
Chairman, Recombinant DNA Advisory Committee
Adjournment
PROCEEDINGS
(9:05 a.m.)
CHAIRMAN KASS: Could we get started?
Welcome to this, the fifth meeting of the President's Council on Bioethics, actually the fifth meeting in a grueling six months, and I want to welcome council members back after a short hiatus. And we're very grateful to you for being here.
This is a regular meeting, and we have a full agenda after this session, including return to the discussion of the patenting of human organisms.
This afternoon we will have a report from Dr. Wendy Baldwin from the NIH on the implementation of President Bush's stem cell policy of last year.
At the end of the day, the last session, we have Dr. Ted Friedmann, who will be discussing with us the possibilities for genetic enhancement of athletic performance.
And then tomorrow morning we will return to what we call in-house search for a richer bioethics and pursue with the question of the relation between human identity and the body, using a wonderful short story by Richard Selzer called "Whither Thou Goest."
And we will finish with a discussion of our future plans and have time for our usual public comment.
The first session this morning is devoted to the release of our report to the President, "Human Cloning and Human Dignity: an Ethical Inquiry." Here is the text, and I hope all of you have them at your place.
This is a pre-publication copy, not the final copy, made available for the first time officially today. No copies were distributed in advance. They are available at least until the supply is exhausted on the table outside, and after the supply is exhausted for anybody who is interested, there will be extra copies of an executive summary.
The text of the report will be available if the promises are kept
on line in HTML form by 10:00 a.m. this morning. The Web site is
www.bioethics.gov.
I want to begin by expressing my personal thanks to the members of the Council for your superb efforts at meetings, between meetings, and in your comments, your critical suggestions to the multiple drafts made by the staff.
You were selected not to be some rubber stamp body, but to be the heterogeneous and thoughtful and articulate group that you are. Our opinions in this room have been keenly held and in sharp disagreement, but they have been well articulated, and this is perfectly appropriate because the issues are vexing; the passions are high; and it is very, very hard to think one's way through this.
Nevertheless, it seems to me that we have done exceptionally well in proceeding in the spirit of goodwill and collegiality and with respect, even some appreciation for the viewpoints which are not our own. And I thank you very, very much for proceeding in that spirit.
I also want to express my deep gratitude to Dean Clancy and wonderful Council staff for your monumental efforts under very trying circumstances to produce this document.
We've had three weeks since the last meeting, and this document is some 145 pages, plus personal statements, plus bibliography, plus glossary. And the staff is to be commended for just heroic work.
The procedure this morning is as follows. I will make an opening presentation of the report. Then there will be time for brief comments, ladies and gentlemen, up to two minutes from those members of the Council who have notified the Chair in advance that they wish to speak. And then we will take some questions from the media.
There is a microphone there, and if you will step forward when the time comes.
I'd like to begin by putting the report of the Council in its context, and to begin by reminding everyone of the mission of this Council according to the Executive Order that was used to create us. This is in the preface.
"The Council's purpose is to advise the President on bioethical issues related to advances in biomedical science and technology, and in connection with its advisory role, the mission of the Council includes the following functions: to undertake fundamental inquiry into the human and moral significance of developments in biomedical and behavioral science and technology; to explore specific ethical and policy questions related to these developments; to provide a forum for a national discussion of bioethical issues; to facilitate a greater understanding of bioethical issues; and to explore possibilities for useful international collaboration on bioethical issues."
This is, to begin with, an ethics council, and our first questions will not be simply will it work, is it safe, and how much does it cost. But is it good, right, just, noble, wise, and prudent?
And first, even before getting to that question, the first task is: what does all of this mean? The first assignment is to explore the human and moral significance of these developments, and that is the spirit in which we have been proceeding.
Second, why the subject of human cloning? Why was this our first project?
First, because there have been steps moving fairly rapidly beginning with mammalian cloning over the last five years, and there was the announcement last fall of perhaps the first successful attempt at the cloning of human embryo, and there are reports that some fertility specialists are, even as we speak -- unsubstantiated reports, that there are efforts undertaken to produce a cloned child.
This has been the subject of intense public debate, and it is a debate which has been complicated because of the discovery of human embryonic stem cells which hold enormous promise for regenerative medicine, and therefore, the question of the promise of cloned stem cells emerges as an issue in this discussion.
This was not a topic of the discussion when the National Bioethics Advisory Commission had to take up this report, this topic five years ago.
Nevertheless, it seems to me the reason that we have taken this up is because the power to clone human beings is not really just a new tool for overcoming infertility, nor is it just an adjunct to the treatment of disease, but it seems to involve a crossing of the line between sexual and asexual reproduction. It might possibly represent an early step toward the genetic control of the next generation.
And lots of people sense that in this issue are things even beyond the importance of cloning itself, that this might be something as a first instance of something quite momentous.
The group process, I will just sort of make it clear how we have proceeded. We have met now -- this is the fifth meeting in which we will have met to discuss human cloning. We have had 12 90-minute conversations on this subject.
We've heard presentations on the recent cloning report of the National Academy of Sciences; presentations on stem cells, embryonic and adult. We've had a presentation on the ethics of embryo research and on the international systems of regulation of embryo research and assisted reproductive technologies.
We've had a great deal of public comment, both oral and written, and we have done a fair amount of reading and discussing amongst ourselves.
I want to say before turning to highlights of the report proper, say something about some of the principles that have guided us.
First of all, we didn't begin simply with the technique and its impact, but chose in all cases, wherever we went in this report, to discuss things on the plane of the human goods that these technologies could either serve or threaten.
In the first case, the importance of human procreation, individuality, questions of the relation amongst the generations, the importance of human healing and the adjunct, the great importance of its allied biomedical science and technology.
And finally, the treasured, but delicate relation between science and society, which offers science the freedom to progress to serve humankind, but also always within the moral limits and social norms of the community.
Second, we have not striven here for consensus. It will be reported that this council failed to reach consensus. That would be a deep misunderstanding. There was no desire to produce consensus here in the first place.
There was from the beginning the recognition that these are hard questions, that there were competing views. We wanted them forcefully presented, and just as President Bush did when he tried to reach his decision on embryonic stem cell research, when he consulted as widely as possible and heard from as many different viewpoints as he could, we have decided and we were charged in a way from the very beginning not to be guided by an overriding concern to reach consensus, but to develop these positions in as strong a way as possible so that the President and everyone else would understand what would be gained and what would be lost in choosing A rather than B or B rather than A.
Finally, I want to say something about the relation between the inquiry and its conclusion. Today's news will be entirely about the result. I've learned since coming to Washington that the thing that people care about is the bottom line and are you for it or against it.
We've come to a bottom line, but I don't regard the bottom line as the most impressive thing about our achievement. I think that the more lasting value, I hope, will be in the arguments, the reflections, the reasoning of this report.
The issues are going to be with us long after whatever decision is made on the current topic, and it is my sincere hope that what we've done here could be of some help to people who follow in thinking about these questions.
I now want to hit just some of the high points of the report. I won't read the executive summary except in a few paragraph where I think I can't improve upon what the staff has done there.
But first of all, in the first chapter, which I think is somewhat distinctive of what we have done, we have placed, as I already said, the subject in the larger human context, the context of human procreation, like entity individuality and the like, in the context of the moral meaning of health and the value of biomedical research, in the context of the tacit moral contract between science and society, and lurking behind this, the context of the nature and worth of human life in all its stages.
This is what we lead with in the opening chapter, and it sets the stage.
There's a chapter on the history which touches only very lightly on what has transpired from the time when cloning was science fiction until the time when it is fact at least in mammals and perhaps, perhaps, in humans to come.
Third, a chapter on terminology, and here I think we have something of considerable importance to contribute. Our first effort, and a difficult effort it was, was to clarify the confusing terminology that confounds the public discussion beginning with the term of human cloning itself.
And for people who are interested in the results, what you need to know is the terms that we are adopting here will be cloning to produce children, cloning for biomedical research, and we regard the immediate product of somatic cell nuclear transfer for whatever use as the cloned human embryo.
Whatever the purpose for which cloning is undertaken, the act that produces the genetic replica is the first step, the creation of an embryonic clone. Accordingly, we mean by human cloning the production of cloned human embryos, the earliest stages of developing human life, with the intention of either transferring them to a woman's uterus to initiate a pregnancy or taking them apart in order to procure embryonic stem cells.
The first use of cloning has come to be known as reproductive cloning or just cloning. The second has come to be called therapeutic cloning, research cloning or nuclear transfer or stem cell research.
The Council has chosen for reasons articulated in the analysis in Chapter 3 to call them instead cloning to produce children and cloning for biomedical research. We think these terms accurately describe the two activities involved and allow us then to debate the moral arguments without euphemistic distortion.
Whether we favor or oppose cloning to produce children, whether we favor of oppose cloning for biomedical research, we must acknowledge that both uses of cloning begin with the same act, the production of cloned human embryos.
Next, in the fourth chapter, which I will not review, is scientific background which touches quite a number of things that are relevant at least in the continuing consideration of our report. We have drawn very heavily on the marvelous report of the National Academy of Sciences on the scientific and medical aspects of human reproductive cloning, and that report was a great blessing to our efforts.
Next, to now turn to the ethical discussions, the rest of these remarks will be about the ethical discussions, and then finally the policy recommendations.
In Chapter 5 we deal with the ethics of cloning for biomedical research. We do consider the case for cloning. Excuse me. Sorry. I misspoke.
The ethics of cloning to produce children, and we do consider the case in favor of cloning to produce children from the treatment of infertility to the replication of a loved one or even of individuals deemed to be superior. But we are not persuaded by this argument.
And we make a case against human cloning that builds on, that goes beyond the case that has been made by our predecessors. We concur that cloning is unethical at this time because it is unsafe both to the prospective children to be, as well as to the participating women who are either egg donors or carriers.
But we try to extend the discussion of the safety question into an abiding moral concern grounded in our duty not wilfully to put at grave risk the children to be who would be the products of this activity, and we raise serious questions as to whether the safety concerns are merely temporary or whether they might be enduring and even permanent.
Second, we go beyond the discussion of safety to undertake the broader ethical critique that was recommended both by the National Bioethics Advisory Committee report and by the National Academy of Sciences, and there by means of a primary discussion of the nature of procreation, we mount a larger critique of human cloning, raising questions about issues of identity and individuality, concerns about steps leading toward manufacture, questions of the possibility of an opening here to eugenics in this primary and initial decision that would involve the genetic modification, the genetic preselection of the genotype of the next generation, questions of troubled family relations, and also certain concerns about the effect on society that has become a cloning society even if it is practiced only on a small scale.
All members of the Council find all of these reasons equally persuasive, but we've put them before everyone for their serious consideration. The conclusion in that section is not only is human cloning unsafe, but it is also morally unacceptable, and it should not be attempted. There the Council is unanimous.
Coming to the difficult topic, much more difficult topic, on the ethics of cloning for biomedical research treated in Chapter 6 of the report, here I would like to read a paragraph from the executive summary on page 18.
"The ethical assessment of cloning for biomedical research is far more vexing. On the one hand, such research could lead to important knowledge about human embryological development and gene action, both normal and abnormal, ultimately resulting in treatments and cures for many illnesses and disabilities.
"On the other hand, the research is controversial because it involves the delivered production, use, and ultimate destruction of cloned human embryos, and because the cloned embryos produces for research are no different than those that could be used in attempts to produce cloned children.
"The difficulty is compounded by what are for now unanswerable questions as to whether the research will, in fact, yield the benefits hoped for and whether other promising and morally nonproblematic approaches might yield comparable benefits. We simply do not know."
The Council, reflecting the differences of opinion in American society, is deeply divided regarding the ethics of research involving cloned embryos, but -- and this point I want to stress -- we all agree that the parties to this debate have concerns vital to defend, vital not only to themselves, but vital to us all.
No human being and no society can afford to be callous to the needs of suffering humanity or cavalier about the treatment of nascent human life or indifferent to the social effects of adopting one course of action rather than another.
What we've done in Chapter 6, and this is an experiment, we have put together in one document not a search for consensus, but in fact, two or two and a half briefs made in the first person plural by proponents and opponents of cloning for biomedical research.
Both sides have been asked to consider what is owed to the embryo. Both sides have been asked to consider what is owed to those who suffer. Both sides have been asked to consider what is owed to the entire society.
And the conclusion, I think, just to simply state the conclusion and allow me to read the rest, the moral case for cloning for biomedical research is powerfully stated. It rests on our obligation to try to relieve human suffering, an obligation that falls most powerfully on medical practitioners and biomedical researchers.
We, speaking for that group, who support cloning for biomedical research, all agree that it may offer uniquely useful ways of investigating and possibly treating many chronic debilitating diseases and disabilities, providing aid and relief to millions.
We also believe -- I'm now speaking from the mouth of the proponents -- we also believe that the moral objections to this research, though genuine, are outweighed by the great good that may come from it.
At this point there was a division in that group. Some see much greater moral concern in the risks of going too far and other moral hazards and would argue that this research needs to be extremely carefully regulated.
A small number of Council members do not believe that the very, very early embryo has that kind of moral standing, would favor this research with enthusiasm, but both of those groups are absolutely in agreement on the importance of the research and give it their ethical approval.
The second group presenting the moral case against cloning for biomedical research acknowledges the possibility, though still speculative at the moment, that medical benefits might come from this particular avenue of experimentation, but we, now speaking for that group, believe it is morally wrong to exploit and destroy developing human life even for good reasons, and that it is unwise to open the door to many undesirable consequences that are likely to result from this research.
This group finds it disquieting, even somewhat ignoble to treat what are, in fact, seeds of the next generation as near raw material for satisfying the needs of our own, and they make various kinds of moral arguments which I will not here research.
In short, what we've tried to do in that chapter is not reach a conclusion, but to present full throated defenses of the two sides, each side also having to address the other side.
Perhaps one word with respect to the second position, which acknowledges that they must pay heed to the voices of the suffering and will accept the burden of perhaps saying no to things that might be beneficial to claims that they want to leave to our children, a world in which suffering can be more effectively relieved, but also a world in which one wants morally to live.
Next, in Chapter 7 we discuss the various public policy options. Mindful of the importance of scientific freedom and the need for moral boundaries and mindful of the way in which human cloning in other countries has not been dealt with in isolation, as we have largely done it here, but in the context of embryo research, reproductive technologies, and genetics, and we outline and discuss the strengths and weaknesses of seven different policy options from no legislation and self-regulation to a permanent ban on everything.
In the final chapter, the Council, having thought about those seven options, coalesced around two recommendations, which we put forth as alternative recommendations flowing from this Council, and these are as follows.
The majority recommendation -- this is in the executive summary on page 21 if you are following -- ten members of the Council recommend a ban on cloning to produce children, combined with a four-year moratorium on cloning for biomedical research.
We also call for a federal review of current and projected practices of human embryo research, pre-implantation genetic diagnosis, genetic modification of human embryos and gametes and related matters, with a view to recommending and shaping ethically sound policies for the entire field.
And there follow then, and the hour is late, a whole series of arguments in defense of this proposal, the most important of which is the claim that there is a need for ongoing public moral debate before one decides to cross this grave moral threshold, which the proponents of this view believe either should not be crossed or should not be crossed as yet without further deliberation.
And some members supporting this position support the moratorium because they would like this temporary ban to provide the incentive to develop schemes of regulation that, should the ban be lifted, might allow this research to go forward, and they also want cloning to be considered -- all of us want cloning to be considered -- in the larger context.
I should say that the Chair belongs to that party.
The other recommendation supported by seven members of the Council and on page 23 recommend a ban on cloning to produce children, but -- sorry -- and recommend with regulation the use of permission to use -- this looks like there's a typo here.
They recommend that there be a ban on cloning to produce children, but support, approve now the use of cloned embryos for biomedical research, but with regulation.
And here the argument is clear, again, that the permitting cloning for biomedical research now, while governing through a prudent and sensible regulatory scheme, is held by this group to be the most appropriate way to allow the important research to proceed, while insuring that the abuses are prevented.
This group does worry about some of the dangerous consequences, but believes that a system of careful, strict federal regulation could prevent those untoward effects, and they want to lend their support to allow this research to go forward at the present time.
That is the main body of the report. There is a bibliography, and in keeping with the spirit of our enterprise and in order to contribute to further public discussion and to continue to allow individual members here to speak in their own voice, you will find at the back of the report an appendix of personal statements in which individual members who have chosen to do so have added their own statements, and we commend them for your attention.
There should be two supplements. There was error in the version of Dr. Foster's statement that was included in the book and Dr. Rowley's statement is available as an insert. I hope it's in the volumes that you picked up. If not, it's available in the back.
Finally, let me just say since the newspapers are already speaking about what the legislative implications are here, and let me say that I would say that as I understand what it is that is being recommended by the two sides, the view of the majority is that there should be no legal human cloning of any sort at this time, and that pending the necessary debate and review both of cloning and of the whole area, that only a moratorium could make possible that no law should now be enacted that would authorize or approve human cloning, that would give the green light to it.
The other position, the minority position, argues that cloning for biomedical research should now be approved legislatively in principle, but it should not proceed in the absence of an enforceable system of federal regulation. That I take to be the gist of what this means for people who want to know what does this matter to the debate that goes elsewhere.
That is it. I'm sorry to have been a little long winded, but I'd rather err on the side of thoroughness.
I have six people who have asked to make short personal comments beginning with Rebecca Dresser.
PROF. DRESSER: Thank you for this opportunity.
Settling on our final recommendations was difficult for me and for others on this Council, but as a teacher and student of bioethics, I'm proud to have played a role in shaping this report.
The report, of course, is not perfect, but I think it is a full and fair examination of the issues, and I believe that it will advance the public and policy examination of human cloning.
As a member of this Council, I believe I have a responsibility to consider not just my own views, but also those of others with interests in our national policies addressing research using human embryos. I do not think we have sufficient agreement in this country about the morality of producing embryos for research to adopt the regulation approach that Proposal 2 endorses.
Going forward at this point could be divisive and could reduce the chance for developing an oversight approach that would be acceptable to a majority of citizens.
Proposal 2 could actually be criticized for going too far in labeling cloning for research permissible, but it could also be criticized for not going far enough in that it really doesn't address the federal funding question.
Without federal funding, little of the basic research that scientists want to do is likely to go forward. For many years Congress has prohibited federal funding of any research that destroys human embryos. With time for further deliberation and further scientific work to indicate whether it is necessary to create embryos to develop stem cell and other therapies, it is possible, I think, a consensus will emerge on the appropriate national policy to govern this very contentious issue.
Now, that consensus might be to go forward and to provide federal funding for the work, or it might be to refrain from permitting production of research embryos because of the moral objections and because there are alternative research approaches to developing therapies.
The issue of whether to approve cloning for research is not ripe for policy resolution. It's not ethically ripe, and it's not scientifically ripe. It's too early to know whether or not people in this country believe that possible gains to patients justify the risks and losses that could come from creating embryos for research, and it's too early to know what we would be giving up if we refrained from taking this step.
Possible benefits to patients are not the only ethical consideration bearing on research policy, and studying stem cells from cloned embryos is not the sole avenue to delivering benefits to patients.
In the next four years, there will be many other research opportunities to investigate the potential benefits that stem cell studies could produce and many other opportunities to benefit patients through better delivery of existing health care services.
These alternatives will, I hope, be pursued during four years of continued deliberation over the creation of embryos for research purposes.
Thank you.
CHAIRMAN KASS: Thank you.
Paul McHugh.
DR. McHUGH: Thank you very much, Leon.
I wanted to comment on this report and my position on it in relationship to my views of SCNT, or somatic cell nuclear transplant, that I have articulated at this table and have put at the end of the report.
As you know, I believe that SCNT is an issue of wonderful new discovery in cellular biology and it represents a form of biological engineering that, at least at its onset, produces cells and not human beings, and that those cells, therefore, are licit to be used in various ways.
I don't want to further that discussion right at the moment, but I do want to draw from that why I then choose to speak about a moratorium here, as our country thinks further about the implications of the use of this form of biological engineering and study.
I believe that there are three problematic aspects that still remain unresolved even if you accepted my position of SCNT, and these problems need to be worked out and thoroughly discussed as to their implications for the future by the American people, and I believe only a moratorium that calls attention to these three problems -- by the way, there are many other problems, but these three problems, one an immediate problem, one an imminent problem, and one an ultimate problem.
Two of them have been discussed before in this Council. An immediate problem is that the requirement for SCNT, human SCNT, is to find human oocytes. If this research is to go forward, there are going to have to be hundreds, maybe thousands of human oocytes, quote, harvested from women.
I fear and see the turning of some women into egg factories, and no man or woman can look at that with ease and comfort.
We should be talking about what that means both practically and morally.
The second, less immediate, but an imminent problem comes out of my opinion that SCNT at first produces cells, and that those cells are suitably used. My colleagues and others have pointed out to me that this phase is just one phase in the potential of these cells, and that these cells could be put into some artificial or real uterus and developed further for the production of organs; that if the cells of the SCNT could be harvested, why couldn't the organs be harvested?
And I believe that we should be talking about what that would imply, using a fetus for the production of organs, and again, I think a moratorium would help to see that.
But then there's an ultimate problem, and it's a problem that relates to the existence of this technology and the potential ultimately of producing a child. And this, of course, is the issue that we want to address by banning human reproductive cloning.
Now, I don't feel that anything that has been said in here or in the National Academy of Sciences has really come to some of the ultimate issues that relate to human cloning for reproduction that our beginnings could permit.
Let me remind you that Charles Krauthammer's favorite animal is Dolly, and I've been looking at it since he's called that to my attention, and a recent ad has shown Dolly with her lamb, and that really drove home something to me and, I think, anyone who looks at this picture and imagines it in human terms.
That is, that a human cloned would then be able to reproduce, and the reproduction would go through and produce a lineage of genes from that cloned product.
Now, I do not know that anybody can assure me that the process of scrubbing the genome that is represented by SCNT will not in some way produce delicate but important changes in the genomic structure that would then pass into a lineage forever.
I work with Huntington's disease patients. Huntington's disease is an extremely interesting disorder at one level in that it represents the expansion of a trinucleotide repeat in the genome of a human being.
We have many trinucleotide repeats in our genome, but very few of them -- fortunately, none of them tend to go critical and expand and, thus, produce a condition like Huntington's disease, which passes on generation after generation.
Diseases like Huntington's disease, fragile X syndrome, some forms of muscular dystrophy, and others represent lineages from trinucleotide repeats that went critically in some family.
I think it's an ultimate and perhaps enduring question as to whether the manipulations of this human genome may not in some way produce a lineage of disorder. Some of them that we know of, like Huntington's disease, are some of them that might be new pathologies that would then go generation after generation produced by the science of today.
And I'm concerned about that to the point where I think that we should be discussing it as also a third issue in a moratorium and heading towards regulation.
In fact, when I think about it, I'm sorry. I depend in my clinical work, of course, on very much basic science, and am very sorry to speak for anything that hinders and slows science. But I do think that this is a situation that calls for that in these three ways.
And I'm disappointed, in fact, that the scientific community hasn't come forward to say that there would be a voluntary moratorium while they considered these matters and discussed them thoroughly as to their implications for the future.
Thank you.
CHAIRMAN KASS: Thank you.
Michael Sandel.
PROF. SANDEL: Thank you, Mr. Chairman.
Some may be surprised that this Council is not recommending a ban on cloning for biomedical research. Neither of the policy recommendations this Council has put forward endorses the ban on research cloning passed by the House of Representatives last year.
Some members of this Council, a sizable minority, have argued powerfully for such a ban. Although they did not persuade a majority to accept their view, their position is worthy of the utmost respect.
Among those of us who hare rejected an outright ban, most would permit the research to go forward subject to regulation, whereas some favor a moratorium.
These positions are laid out clearly and candidly in the report in the table on page 129. Seven members favor a ban, seven favor permitting the research subject to regulation, and three favor a moratorium.
When the membership of this Council was first announced, some critics complained that President Bush had stacked the Council to insure a particular outcome. I believe that this report, if carefully read, will put that charge to rest.
The President could easily have stacked this Council to guarantee support for a ban on cloning for biomedical research, but he didn't do that. He wanted a group of independent minded people who would wrestle honestly with hard ethical questions so that the best arguments on all sides could be placed before him and before the American people.
The President deserves enormous credit for that choice, which I believe will serve him and the country well in the long run.
And our Chairman, Leon Kass, deserves great credit and appreciation for leading these discussions with integrity and fairness.
CHAIRMAN KASS: Thank you.
Alfonso Gómez-Lobo.
PROF. GÓMEZ-LOBO: It has been a great honor and a deeply felt responsibility for me to contribute to the deliberations on human cloning of the Presidents' Council on Bioethics.
After much thought, much difficult thought, it seems to me that human cloning, if carrier out, will represent a major step towards a radical instrumentalization of human life. It would be the ultimate transformation of a growing and developing human being into mere research for experimentation.
That a human life begins shortly after fertilization or of somatic nuclear transfer is neither a matter of subjective opinion nor of religious belief. And I want to insist on this point.
By itself, that is, without the contribution of science, none of our major religious traditions is equipped to decide the issue. When our life begins is a matter to be decided not by faith, but rather by reason in light of contemporary embryology.
As a recent article in the journal Nature, July 1st, the journal Nature shows, the mammalian body plan with its diverse functions starts being laid down -- and I literally quote from the Nature article, from the moment of conception, unquote.
To claim that a human embryo cloned or naturally conceived is a clump of cells is like describing a car as a bunch of wheels. This expression totally misrepresents the structure and nature of an automobile.
Likewise, an embryo is much more than a heap of cells. It is a unified organism, a self-moving whole programmed from the start to go through its natural stages until she becomes, if given the appropriate conditions, an adult like us.
An embryo does not yet have a functioning nervous system or a brain, but if nurtured properly and not wilfully deprived of her natural surroundings, will have them within a short time. Sentience and thought are natural outcomes of the earlier stages.
The very idea of cloning for biomedical research rests on the assumption that the internal genetic program of the embryo is at work and will lead to the blastocyst stage, and at this point stem cells will be extracted.
It would be a euphemism to say that the embryo is then lost. It is, of course, intentionally dismantled.
The recent advance for research cloning, of course, is the promise of cure for numerous illnesses. My family and I, I must confess, are among those who would benefit tremendously from those cures.
But -- and I pose the question to myself ?- does this admirable and desired end justify the questionable means? And after much thought, I have to answer no.
As a result of all that I have learned from my colleagues and from the material provided by the excellent staff of the Council, I would like to make two exhortations.
One is an exhortation to all Americans to familiarize themselves with embryology and the real nature of research cloning. It is not simply a procedure directly to produce stem cells. It is a procedure that entails producing human organisms, letting them grow according to their own devices, and then destroying them.
Any suggestion that this can be done in a morally permissible way before 14 days is, in my opinion an illusion. There is no bright or dim light at that point. We were already before 14 days the human beings we are now, and this, above all, should be a deep concern to our legislators.
My second exhortation is to those members of the community who have devoted their lives to science and medicine. We admire you; we support you; and we depend on you for our own well-being and that of our children and grandchildren.
But we urge you to be mindful of the ethical implications of dealing with human subjects who cannot give consent and are going to be treated as mere instruments for the benefit of the rest of us.
We urge you vigorously to pursue truth and healing, but in strict observation of the principle that commands us never to treat a fellow human being, no matter how young, merely as a means towards our ends.
Thank you.
CHAIRMAN KASS: Thank you.
Let me see. Janet Rowley. Mike, do you want to go first?
I want to alternate. We have two new additions, and I'd like to bring you in. Mike, would you like to go?
DR. GAZZANIGA: Sure.
CHAIRMAN KASS: Mike Gazzaniga.
DR. GAZZANIGA: I think Mike Sandel stole my notes. I echo completely his sentiments and his statement that this committee has worked fairly and in the open, and every time one would call with a suggestion, the answer always was, "We'll put it in there."
There never was any sense of override. There never was any blocking of any point of view. And for those of you who actually read the report, every viewpoint that the individuals of this committee have is represented in the report.
I do want to remind that this is a committee not of scientists, but of professionals looking at ethical questions, and echoing Mike Sandel's point, on page 129 the majority of the committee actually has no problem with the bioethics of biomedical cloning, but we vary in the extent and speed with which we want to go forward.
I would just conclude with the thought that it is our great intellect that finds many of us at this table still alive from prior biomedical advances, and I think the objective of biomedical cloning is have us alive and healthy during these aging years. So I hope the process will go forward.
Thank you.
CHAIRMAN KASS: Thank you, and a long life to you, Mike.
Let's see. Gil Meilaender.
PROF. MEILAENDER: I wanted to say just a few words about the policy a majority of our Council has recommended with respect to cloning for biomedical research, a policy that I support.
That recommendation, a four-year moratorium, is in some ways not the very best policy that I can imagine. The best would be simply to try to say a lasting no to all human cloning for reasons one can find set out in detail in parts of Chapters 5 and 6 of our report.
Not all Council members agree, but some of those who do not yet agree -- note the hopeful tone there -- some of those who do not yet agree share many more reservations about proceeding with research cloning now. Our partial agreement is, I think, a considerable achievement, given the circumstances under which we've forged it in a rather short time.
Were it enacted into law, it would prohibit all human cloning whether publicly or privately funded for four years. That is to say for that period of time, we would have the best policy in place, and our deeply divided society would have continued opportunity to think, to talk, and even to argue about the morality of human cloning, opportunity to take seriously the limits on our own wisdom and goodness, opportunity to question even our most praiseworthy motives.
Beyond that, I make three observations, each very brief, about the worth of a moratorium.
First, some might describe our four previous meetings of a day and a half each over a half year as six months of searching ethical and scientific inquiry. I think that sets the bar too low, lower than I'd want to set it anyway.
I think, on the contrary, that neither this Council nor our society has really yet fully plumbed the depths of the moral issues in human cloning and embryo research. There's much more to be done, some that we haven't done, some that we've hardly been willing to do, and we can use a moratorium to think more deeply and fully.
Second, I used to think that I could never care about any child the way I did my own children. then I spent a decade as a foster parent, and I learned I was wrong. My feelings and my moral sensibilities had not been a very sound moral guide. They needed to be reshaped and redirected, and that really took years.
Perhaps the feeling of those like myself who see an industry of research cloning as abhorrent are wrong. Perhaps, on the other hand, the feelings of those who see relatively little moral problem with cloning for biomedical research are an unsound moral guide.
It will be good for our moral health to take more time to think this through.
Third, Oscar Wilde is famous for having described the cynic as the man who knows the price of everything and the value of nothing. We're engaged; we have been engaged in an attempt to think through some very important questions about the value of things, questions that cannot be reduced simply to costs and benefits.
I believe it will serve the moral health of our society to take additional time to do so.
Thank you.
CHAIRMAN KASS: Thank you.
Now Janet Rowley, please.
DR. ROWLEY: I, too, want to echo the compliments of my colleagues around the table both for Leon specifically as well as for the staff for the openness of the discussion that we have had in these last months, and many of you in the audience have been here and sat through a day and a half of discussions, and I salute those of you who were in attendance because I think it was a surprise to me to see that all of our deliberations would be conducted in this kind of goldfish bowl, but I think it's a very strong and important statement for the country to see the discussions and the meeting of intellects, if not the coming to agreement of individuals trying to deal with very, very serious issues.
And I think that it is important to emphasize that those of us in the scientific community who would espouse more progress certainly recognize the very sensitive issues that we are dealing with at this particular time. It's been raised both in the report by Dr. Kass and by others that we have asked many questions during this time, and we've found answers.
I want to focus on why we have so few answers to the questions, the critical questions, that we have asked. And for me the answer is shockingly clear. Most American scientists have been prevented from working on these very critical problems because of a ban on any federally funded research using cells from human embryos, and this ban has been in existence since 1994.
We're not proposing that we stop active research now. We're saying that we should continue this prohibition on research by federally funded scientists, which really has been the engine of all biomedical progress in the past.
And I have to say why continued ignorance is a wise public policy escapes me.
It is clear that in addition to wanting to move ahead with funding research, that as I've already said research using these cells requires great sensitivity and careful thought.
And as a matter of fact, all academic institutions have an institutional research board in place where the research that is proposed, particularly that involving human subjects, is very carefully reviewed by the institution before grants can be submitted to any agency.
In fact, in 1998, NIH had a working group developed that proposed guidelines for pluripotent stem cell research, and this was approved after extensive public comment. More than 50,000 comments were received in response to the announcement, firstly in the Federal Register, in the final report, and guidelines were published in the Federal Register in August of 2000.
And at that time, there was a proposal for the establishment of the human pluripotent stem cell review group. In fact, this group was constituted, but because of the election never met.
The group consisted of -- broadly represented the American public with consumers, ethicists, lawyers, as well as scientists.
And so despite the claims in part of our report, there is no evidence that I'm aware of that scientists oppose the formation of such a research board. In fact, as I've already said, members of such a board were already selected.
The proposal, again, in our part of our report, to exclude knowledgeable scientists from the review panel will, I think, perpetuate the serious handicap under which our own Council has labored in not having experts as members of the Council who are constantly available to inform us in our discussions.
We are dealing, as we've all discussed with competing moral goods, and we spend a great deal of time, of paper, many pages discussing the moral rights of a single cell.
There's very little discussion of the moral rights of patients and the potential benefits to humanity of this research. Again, part of this is because of our ignorance, and our ignorance is due to the fact that we cannot do the science that's required to answer these questions and to spend four more years in ignorance, I think, is extraordinarily distressing at least to me.
So I think that Congress should lift the ban on human embryonic research and should establish a broadly constituted regulatory board now.
CHAIRMAN KASS: Thank you very much.
The last comment is from Charles Krauthammer.
DR. KRAUTHAMMER: Like Professor Meilaender, although for possibly different sets of moral reasons, I oppose all cloning, reproductive and research. I would like to see them banned.
But I live in the real world, and in the real world there is no consensus either in American society or on this Council for such a permanent ban right now.
And I might say in echoing the remarks of Professor Sandel that the fact that the pluralism on this issue in the country is reflected by the pluralism on this issue in the Council gives lie to the impression widely disseminated that this Council was stacked to produce an ideological result.
The fact that we have produced this variety of opinions and this kind of division, I think, gives light to that. Not only have the members of the Council with differing opinions shown respect for each other's positions, but they have both in our discussions and in the report recognized the valuable goods represented by the other side, and that one necessarily forfeits in proposing ones own position.
Given this pluralism, I think that recommending a moratorium as the majority of this Commission has now done is more than a compromise. It's an achievement.
And the reason it is an achievement is because the creation of human embryos solely for the purpose of experimentation is a significant moral barrier, and by proposing a moratorium, we recognize the significance of the barrier and the importance of it not being crossed.
Creating embryos solely for their exploitation and research and therapy is new. It's dangerous, and I believe that we will live to regret it were we to allow it to go ahead.
The reason the moratorium is so critical is because without any such action today it will go ahead. We already know that the Jones Institute has created human embryos using sperm and eggs for experimentation. We know that Advanced Cell Technology has attempted to create human embryos solely for experimentation using cloning techniques.
In the absence of any action here, in the absence of any action by the Congress, this barrier will be breached.
I think the importance of what we have done is that a Council of people drawn, as Michael Sandel pointed out, from the different perspectives, reflecting different points of view, that such a Council has come together and recommended in the majority that this barrier not be breached is extremely important. It represents a recognition that the country needs, and I think it is a significant contribution to the debate and to the moral health of the country.
Thank you very much.
CHAIRMAN KASS: Thank you very much.
As a matter of personal privilege let me say that I am just thrilled with the comments that have just been made around the table and not simply for their kind words for the Chair. People who are with us for the first time have just gotten a taste of the kind of discourse that we've been having here.
I can't say I'm sorry we're finished with human cloning, but this was a very nice way for the Council to finish its discussion, and I thank you all for the thoughtfulness and high moral principle behind all of the statements, and I'm very grateful.
We now invite people from the press to come to the microphone and ask questions. We have another session beginning at 10:45. So this will be brief. We'll take a break, and then people can speak in the interim.
But please step forward to the mic and identify yourself and ask whatever questions you might have.
There will be a session tomorrow for public comment. This is not the occasion for editorial complaint, but really for questions.
MR. VERGANO: My name is Dan Vergano. I'm with USA Today.
CHAIRMAN KASS: Could you speak up better or could we get the microphone a little --
MR. VERGANO: My name is Dan Vergano. I'm with USA Today.
CHAIRMAN KASS: Thank you.
MR. VERGANO: What I'm wondering is did any of the Council members change their original opinions or notions about this topic as a result of this process.
CHAIRMAN KASS: This has been a roller coaster of a conversation. I mean, there are some people who probably remain at the end where they were at the beginning, and other people have wrestled very hard and, as best I can tell, may have changed their minds certainly if not exactly about the morality of the question, at least about the right way that we should proceed as a society.
But it seems to me personal confessions might be in order if you want to buttonhole people around the table, but, no, I think from where I sit it seems to me there has been some movement in some places, and we're not all simply dug in where we began.
And certainly there has been movement in which the power of the other point of view has been clearly recognized in ways in which the heated debate in Congress and other places rarely does. So that, I think, is certainly movement.
MR. VERGANO: Thank you.
CHAIRMAN KASS: Thank you.
Please, Mr. Palca.
MR. PALCA: I'm Joe Palca from National Public Radio.
My question is if at least half the Council and possibly more favor this four-year moratorium where people can work out the proper regulations that would make cloning for biomedical research ethically acceptable or at least done in an ethical manner, who do you recommend derive those regulations?
I mean, are you stepping out of the discussion now and saying others should do it, or are you saying we will continue and come up with what we feel are a set of ethical guidelines?
CHAIRMAN KASS: No. Thank you very much.
First, I'll just correct the facts. I mean, the ten-member majority group that favors a temporary ban on all human cloning, a four-year moratorium on all human cloning, comprises individuals who, as you heard from Gil Meilaender, would like to use those four years to persuade Paul McHugh (a) that this product is really an embryo and shouldn't be used.
There are others who see this not as a down time, but as an opportunity not just to devise the regulations for this, but to locate this in the larger context the way the Canadians have and the way the British have, and to think through this entire area.
This Council has been created with a lifetime of two years by executive order. We go out of business at the end of November of 2003.
We have already begun our discussion of regulation in this whole area, and not just about human cloning in particular. Frank Fukuyama has taken the lead with his book The Post-Human Future to call for such things. We've had several sessions on them. We will have more.
And we will give our best thought to suggestions for either supplementing the regulatory mechanisms that now exist or if we have anything useful to suggest to talk about others, we stand ready to participate in this process.
But we are an advisory body with no decision making authority, and it seems at least to some of us that what this area needs is a consideration that goes beyond mere safety and efficacy, but to some of the deeper moral questions that we're considering and to be able to do so in some kind of an effective way, issue regulations, and enforce them.
At the moment we have, it seems to me, a very partial solution, and that's why we were very interested in the last meeting to learn something about what's being done in other countries. We will continue to do so, but mindful of the differences between the United States and other places.
But thank you very much.
Ms. Stolberg, please.
MS. STOLBERG: Hi. I'm Sheryl Stolberg from The New York Times.
I have three very simple questions. First, why four years?
Second, it appears that Professor Carter didn't vote, and I wanted to know why not.
And third, have you been asked or do you intend to present this report in any way to Congress?
CHAIRMAN KASS: Thank you.
Four is a number less than some wanted and more than others wanted.
Professor Carter has not been able to make any meetings since, I believe -- I think he was there part of the February meeting. He was not present with us in April. He was not present with us in June, and he has been unable to comment and, therefore, has chosen not to participate in this report.
It's not correct to say that he's abstained. It is, I think, more correct to say that he has just not participated in this report. We regret that very much.
And we are responsible to the President. And late last night -- we just got these copies yesterday -- late last night a copy was delivered to the President. We will be glad, I think, to make copies available to members of Congress, but there aren't at the moment immediate plans for such distribution.
Thank you.
Ms. Meckler, welcome.
MS. MECKLER: Hi. Laura Meckler from the Associated Press.
My question is you've said that you hope that this report outlines the arguments, the powerful arguments, on both sides of the issue.
CHAIRMAN KASS: Right.
MS. MECKLER: From a practical point of view, as Congress and, more particularly, the Senate is grappling with this issue, what specifically do you see them doing with this report?
Obviously, one thing that may happen is people will use the arguments that they like to reinforce their points of view. Do you see anything beyond that? Do you think this will change people's minds? Do you think the majority opinion, albeit a small majority, will carry some weight with those who might be undecided?
Could you just talk about the practical impact?
CHAIRMAN KASS: Well, the truth is it is not for this body to hazard many guesses as to what other people are going to make of it. The Senate is a large, powerful, independent body, and you'd, I think, probably have to give them time and ask them what they will say.
I would say only two things. If somebody reads carefully, they will see that the two proposals that have come from this Council are neither of them explicitly represented in the alternatives that are present before the Senate. The more permissive proposal does not call for the prior establishment of strict regulations, and if you look at the document, what the minority is calling for are things that are really quite, quite strict and extensive.
And I commend you to Chapter 8 for the details.
The majority recommendation calls for not a permanent ban, but calls for a permanent ban on cloning to produce children, but a four-year ban on all human cloning so that this debate can continue, so that those who want to seek for regulations can do so, so that there will actually be an incentive for people to continue to carry on this conversation because the green light will not have been given.
Some of the members of the Council -- this political debate was swirling around us all the time we were working. It made life interesting, but we tried to follow our own line on this, not to be unduly influenced by what was there.
On the other hand, at least some of us have been distressed or at least concerned that after much public debate both in 1998 and in the current session of Congress, that the result might be simple acquiescence in whatever Dr. Antinori and other people do, and that we regard that as regrettable.
If the Senate would be interested in adopting this proposal, you'll have to ask them, but it might be a way past this impasse.
Please.
MS. BOYCE: Hi. I'm Nell Boyce with U.S. News & World Report.
I wondered if the panel, those who were in favor of a moratorium in terms of giving time to produce adequate regulation and oversight over research use of cloning, if they considered or it was discussed what impact it might have if one of these groups working on human cloning for children actually came forward with a successful birth of a child through somatic cell nuclear transfer.
I wondered. You know, four years is a long time, and I wondered if that was something that was discussed in terms of giving this time period to develop regulation.
CHAIRMAN KASS: Yeah, I think I'm speaking fairly that we were not -- the time wasn't somehow dictated by the chances of a successful creation of a cloned child. In fact, the Council, I repeat, is unanimous in recommending that this be proscribed permanently.
And everybody understands that even permanent bans -- permanent bans, first of all, can be altered. One can revoke them. And permanent bans do not prevent rogues from violating them, but they can't violate them with impunity and certainly they can't violate them and be praised by the community that regards this as a deep violation of the moral norms.
So I don't think the call for the moratorium of four years was somehow affected by what Dr. Antinori or Dr. Zavos might be planning, but rather by, as you've heard around the table, the believe that there's an important moral boundary here to be crossed, and that we need time to debate that thoroughly to decide whether we should cross it, and if so, what the costs are both of crossing it and of not crossing it.
One last question, please, and then we will take a break.
MS. LEONARD: Hi. I'm Mary Leonard with the Boston Globe.
CHAIRMAN KASS: Hello, Ms. Leonard.
MS. LEONARD: The position that you've laid out today is not President Bush's position. You said the report has been delivered to him. I wonder, first of all, if you had had any conversations with the President about this; whether you will be urging him to adopt this position and, I suppose, whether you're prepared for him to reject your recommendation.
CHAIRMAN KASS: Well, thank you very much for that question.
No, I have not discussed this with the President. I will not be urging this on the President. He has the reflections and recommendations of this Council, and I'm confident that he is a man who will consider the various issues and reach his own conclusions, as he has done on so many occasions before.
The only one thing I would correct slightly. I'm not sure it's fair to say that the majority of the recommendation is not the President's position. It's not the President's position, if I understand it, that called for a permanent ban on this, but it does not somehow violate.
If it were given effect, namely, that there would be no human cloning of any kind for a time, I'm not sure that that is a contradiction of the President's position, but I think I'd have to leave it to the President and his spokes people to answer for themselves.
Thank you all very much. We are adjourned until a quarter of 11, when we will return to discuss the patenting of human organisms.
(Whereupon, the foregoing matter went off the record at 10:22 a.m. and went back on the record at 10:55 a.m.)
