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Second Meeting Transcript

"This transcript has not been edited or corrected, but rather appears as received from the commercial transcribing service. Accordingly, the President's Council on Bioethics makes no representation as to its accuracy."

Loews L'Enfant Plaza Hotel
480 L'Enfant Plaza, S.W.
Washington, D.C. 20024

February 13, 2002

COUNCIL MEMBERS PRESENT

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

Stephen L. Carter, J.D.
Yale Law School

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, Ph.D.
Georgetown University

William B. Hurlbut, M.D.
Stanford University

Charles Krauthammer, M.D.
Syndicated Columnist

William F. May, Ph.D.
Methodist University

Paul McHugh, M.D.
Johns Hopkins Hospital

Gilbert C. Meilaender, Ph.D.
Valparaiso University

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

Michael J. Sandel, D.Phil.
Harvard University

James Q. Wilson, Ph.D.
University of California, Los Angeles

INDEX

Welcome and Opening Remarks

  • Leon R. Kass, M.D., Chairman

Session 1: Human Cloning 4: Proper Use of Language

Session 2: Human Cloning 5: National Academies' Report "Scientific and Medical Aspects of Human Reproductive Cloning"

  • Irving L. Weissman, M.D.

Session 3: Human Cloning 6: Ethical Issues in "Reproductive" Cloning

  • Working Paper #6: The Ethics of "Reproductive" Cloning: Child, Family and Society

Session 4: Human Cloning 7: Ethical Issues in "Reproductive" Cloning

  • Continued

Session 5: Ethical Conduct of Council Members

  • Q & A with Administration Attorney
    (Not herein transcribed)

PROCEEDINGS

WELCOME AND OPENING REMARKS

LEON R. KASS, M.D., CHAIRMAN

CHAIRMAN KASS: Could we get started, please? I would like to call on Dean Clancy to open the second meeting of the President's Council on Bioethics.

MR. CLANCY: Good morning and welcome back to Washington. You are good to go for this meeting. It is all legal.

One quick announcement. Members and staff are required to receive an ethics training at least once a year. An ethics attorney from the Administration will be available at 5:00 o'clock to discuss the ethics rule. Until then, please bear in mind that as federal employees you may not take part in a discussion of a particular matter that is likely to have a direct and predictable effect on your own financial interests or the financial interests of your immediate family or employer. When it doubt, refrain from weighing in the particular matter under discussion.

CHAIRMAN KASS: Thank you. I would first like to welcome Alfonso Gómez-Lobo , Professor of Metaphysics and Moral Philosophy at Georgetown.

It's nice to have you with us, Alfonso, and glad to see you looking so well.

DR. GÓMEZ-LOBO: Thank you.

CHAIRMAN KASS: I would also like to welcome our special guest, Dr. Irv Weissman, the Karel and Avice Beekhuis Professor of Cancer Biology, and Professor of Pathology and Developmental Biology at Stanford, and the Chair of the National Academies Panel on Scientific and Medical Aspects of Human Cloning, the topic of our discussion later in the morning.

I would like to announce to all members that our web site, a rather spartan one for the time being, is now functional. You can find us at www.bioethics.gov. You will find the transcripts, unedited, posted there, as well as Working Papers and other additional matters.

Lunch for council members will be in the Club Room where the continental breakfast was. The evening for members is free.

If you have logistical questions, please see Emily Jones, who is, I think, standing. There is Emily in the back.

Would you raise your hand?

And people with media questions should see Diane Gianelli, our communications director, in the back.

As Dean said, we will have a lawyer with us at 5:00 this afternoon to deal with any questions we might have.

You have all received the announcement of the subsequent meeting dates. Please hold all of them for the rest of the calendar year. We will not use them all. There will be no March meeting. We are missing four members and, quite frankly, it is something of a rush to get these things set up. We would have to have the next meeting planned by two weeks. So between this meeting and the meeting on April 25-26 will be the time to collect comments from all of you and for our staff to begin to prepare drafts of documents for discussion at that time.

I want to begin with some remarks which will then make a transition into the topic of the first session.

I want to remind us of the charge that was given to this Council: "To advise the President on bioethical issues that may emerge as a consequence of advances in biomedical science and technology."

To offer sensible advice for action, we must first seek clarity in thought. We must examine carefully and critically the specific ethical and policy questions related to biomedical advances. Yet this modest way of describing the work of public bioethics belies the weightiness of our subject. Many of the ethical and policy challenges we shall increasingly face arise because of new and foreseeable powers to intervene in the human body and mind in unprecedented ways and, in some cases, for indeterminate ends.

Though these powers are being acquired as part of the project to cure disease and relieve suffering, their acquisition often raises serious moral questions and their possible uses go beyond the goals of therapy for which they are first sought. Everyone understands, even if only dimly, that how we use these powers could make a very big difference for what it means to be a human being, for us and especially for future generations.

Precisely for this reason, the ethical issues we face necessarily go beyond the utilitarian concerns of ordinary technology assessment, which confines itself largely to questions of "Will it work? Is it safe? And how much will it cost?" They even go beyond the traditional questions of medical ethics or even the ethics governing research on human subjects, with its reliance on informed consent or its application of the abstract principles of "beneficence, respect for autonomy and justice."

To develop a bioethics that does justice to the subject, we need to develop a view that is broader and deeper. We must, to begin with, take pains to locate the new biomedical developments, both with their promise and their peril, within the larger context of human life. We must not merely reactively respond to the potential consequences of this or that particular technological innovation. We must rather prospectively try to articulate the human goods, activities, relationships, and institutions that we wish to defend in advance. Developing the ideas, questions and approaches for a "truly human" bioethics is one of the prime goals of this Council, one that we shall pursue both thematically and, I hope, by example, as we tackle our particular topics.

At our first meeting, we spent roughly half our time explicitly reflecting on how we should conceive and approach our subject. Using Hawthorne's story, "The Birthmark", we considered the meaning of a one-sided pursuit of the otherwise noble struggle against what Bill May called "the un-elected marks that go with our birth," which include -- whether we know it or not -- disease, decay, and death itself.

And we struggled with the question of the extent to which this aspiration is or is not part of the aspiration of modern science and the culture that celebrates it.

With the help of Gil Meilaender's paper, we took up some of the essential themes of a bioethics true to the character of human life: Questions about freedom and its limits; questions about the relationships between the generations, the nexus of connection that we owe to the fact that as finite beings, we beget and we belong in families; questions about the project to relieve suffering and its moral standing among other human goods, as well as questions about what means we may morally use to attain this worthy goal.

In the discussions that followed, people spoke about human equality and human dignity, though with little specification given, as well as about the dangers of trying to subdue the mysteries of life or to seek to exchange our position in the world as "imperfect recipients of a gift" for one of "flawed manufacturers, controllers and designers." We have much more to do on these matters and we shall in future meetings schedule time to consider them explicitly.

For this meeting, however, we shall spend all our time on human cloning, our first short-term project. It is my hope -- nay, my expectation -- that the way that we shall proceed with our exploration of human cloning will show signs of our striving for the richest possible treatment. This means concretely thinking about cloning in the context primarily of human procreation: What it means to have a child; the meaning of "origins" for one's identity and sense of self; what it means to regard the child as a project or a product rather than as a gift given; the difference between "begetting and making"; the balance between what Bill May called "accepting love" and "transforming love" of children; the relation between the freedom to have a child and the great limitation of freedom implicit in the duty to protect, nurture and educate the child; and other comparable matters.

It also means thinking about cloning in the context of the progress of biomedical science, as well as the growing technological powers to assist and control human reproduction, and to influence human genetic endowments.

These considerations reminds us that we are taking up the cloning question not only because it is timely and a matter of intense public discussion to which we have been asked to contribute. Indeed, we can contribute most fruitfully to that discussion especially as what we say keeps these larger contexts in mind. We are mindful that cloning intends not only to produce a child but a child of a particular and approved genetic endowment; in this sense cloning is discontinuous with IVF and stands as a possible forerunner of future efforts at genetic design and even eugenics.

We recognize that the argument about what to do about cloning is, in fact, also about who should bear the burden of persuasion or of proof regarding the introduction of such radical new technological alterations of human life. It also makes explicit the complicated relation between science and society, as freedom of inquiry, innovation, and medical research may be threatened or limited, rightly or wrongly, by public strictures. A broad view makes clear that there is more at stake in the cloning discussion than cloning itself.

The logic of our meeting begins with questions of terminology, moves to the scientific and medical aspects, continues with the ethical issues connected to reproductive and research users of cloning, and concludes with a discussion of the policy issues tomorrow.

Turning now to the theme of this first session, I want to make just a couple more remarks. The first task of any serious and thoughtful inquiry is a self-conscious consideration of how the topic should be described. Terminology matters. The answers one gets are no better than the questions one poses and the questions are shaped by what one chooses to call the matter in question.

Human speech is necessarily precarious and contestable. The word is not the thing. Always there are dangers of mischief and misunderstanding. There is risk of imprecision, euphemism and the ever present temptation to win a moral argument by choosing focus group tested soothing usages.

In our area of bioethics there is an additional and crucial danger of terminological distortion. What are fundamentally human activities are frequently described in merely technical terms and the choices presented are described medically and technologically rather than humanly and ethically. This is especially likely to happen where bioethics proceeds reactively in the face of a new technology, rather than prospectively from the vantage point of human activities involved.

For example, in considering the ethical issues of assisted reproduction, it will be one thing to frame the questions in human terms of having and bearing children and quite another thing to frame it in the scientized (sic) and medicalized (sic) language of reproductive technique and medical risk alone.

As it happens, there is a great deal of confusion about the terms used in discussing human cloning. There is honest disagreement about what names should be used, and there are also attempts to select and use terms in order to gain advantage for a particular moral or policy position. It is terribly important to try to be accurate and fair in the matter of language. Efforts to win the moral argument by Orwellian use of speech must be resisted. This is not just a matter of semantics; it is a matter of trying hard to call things by their right names; of trying to fit speech to fact as best one can.

We should not only stipulate the meanings we intend by our use of terms -- that we must do -- but we should also try to choose terms that most accurately convey the descriptive reality of the matter at hand. If this is well done, the moral argument can then proceed on the merits without distortion by linguistic sloppiness or chicanery.

It is for this reason and for the reason that this question came up so frequently in our discussions last time that we begin our meeting this time with a discussion of terminology. The basis for that discussion is Working Paper 5, a rather detailed analysis of the difference between the what, the why and the how of these activities. We have also had e-mail comments from Gil Meilaender that are included in your briefing book and a late submission came yesterday from Stephen Carter, which is before you in the packet.

I should say, by the way, that you have other materials before you. Some of them provided by the National Academies of Science, and they will be relevant for Dr. Weissman's presentation.

The goal, I think, for this session is simply to discuss the terminologic question as that has been prompted by the Working Paper. The end of the Working Paper has -- offers a certain conclusion as to what it seems proper to mean by human cloning, distinguishing the what, the how and the why. Refer to page 6 of the Working Paper. It then goes on to describe reproductive and research therapeutic cloning in terms of that discussion. And it concludes with a question posed for us: Having done this linguistic analysis, so what? I mean, do we simply make clear how we are using these terms, appending to it this analysis or some corrected version of it so that everybody at least knows what we mean or shall we creatively try to find some other way of speaking about these matters that might not fall prey to the difficulties inherent in any choice that we make?

But, first, I think we should discuss the questions raised by the Working Paper and whether that description is adequate, and then try to figure out what, if anything, we should do to -- what terms we would like to adopt.

With that, I would open the meeting for discussion of the Working Papers and this topic.

Michael, please.


SESSION 1: HUMAN CLONING 4: PROPER USE OF LANGUAGE

WORKING PAPER #5: ON TERMINOLOGY

DR. GAZZANIGA: In the spirit of reducing linguistic sloppiness, speech as fact, if you look at the two definitions there, which basically are what are at stake here in terms of us trying to determine what we mean by those, the reproductive cloning, as stated there, is creating a living cloned human embryo. We stopped there because that is how each definition is launched. I think the case could be made that using the word "creating" is loaded; "living" is redundant; and "embryo" is flat out wrong.

So, in fact, if you think about what is going on is that we are synthesizing a totipotent cell for...and then the rest of the definition is fine. But what is going -- "embryo" is defined in biologic terms as "a fertilized egg, which is two haploid cells coming together, to grow into the organism in question," whether it be an animal or human being. So it is an incorrect use of the word.

I do not think it is a slide point or an irrelevant point. I think it almost focuses our attention on the fact that what a strange thing this is and what we are talking about but what we are actually doing is synthesizing a totipotent cell for the production of a blastocyst in the therapeutic cloning idea for the production of stem cells and for the production of an organism in the other definition but that is what is going on.

CHAIRMAN KASS: Well, this substitute suggestion has got multiple parts that we could investigate.

I am not sure that synthesize -- well, I guess, by "synthesize" you mean, quite literally, to place together. Right?

DR. GAZZANIGA: Coming together of two different chemical elements to produce something else, which is what is happening. You are reprogramming the totipotent cell or the somatic cell to become a totipotent cell and you need the oocyte to do that at this point in our knowledge.

CHAIRMAN KASS: Now, why isn't a cell, which is -- will on its own proceed to divide and develop to the blastocyst stage -- I think there is a certain place earlier in the discussion where it describes this product. It is a cell but it is not an ordinary cell. It is a cell that resembles and can be made to act like a fertilized egg. It not only has the full complement of chromosomes but, unlike a somatic cell, it is capable of developing into a new organism. In other words, it is a zygote or a zygote-like being. Is that --

DR. GAZZANIGA: It is not a zygote.

CHAIRMAN KASS: It is a zygote or a zygote-like being. Do you think that is wrong?

DR. GAZZANIGA: Well, it is a totipotent cell that is being reprogrammed is what it is. A zygote means two gametes have come together to form.

CHAIRMAN KASS: Yes, but what you mean by "totipotent."

DR. GAZZANIGA: Well, totipotent is just the description of the first few cells in a division of a fertilized embryo that have all the potential to become a full human being and that is what miraculously happens when you put a somatic cell in a nucleated oocyte that as far as my understanding is -- actually there is not a lot of understanding on how that actually works. It works. We know it works but that is the -- I mean, embryo -- if you just take the word "embryo," embryo actually is used after -- after the egg or the entity is impregnated so it is actually incorrect -- it would be an incorrect use of the word given you did not -- we did not want to make these distinctions for the therapeutic case because the therapeutic case wants to stop the whole process at the blastocyst stage.

CHAIRMAN KASS: Let me -- I do not want to monopolize the discussion, others want to get in, but let me try to clarify. The brunt of the analysis was to distinguish the lot of the act from the purpose for which it is done. So to do whatever we are doing for the purpose of reproduction or to do whatever we are doing for the purpose of investigation or harvesting stem cells --

DR. GAZZANIGA: That is fine.

CHAIRMAN KASS: -- those are separate.

DR. GAZZANIGA: Yes, that is fine.

CHAIRMAN KASS: What we are trying to discuss now is what actually is the act.

DR. GAZZANIGA: Right. But what is the best biologic definition and I am making a suggestion here. There are many biologists here who can raze me and correct me but that is my thinking of the terminology and maybe we could hold this in abeyance until this afternoon or later on this morning when we have the pros tell us.

CHAIRMAN KASS: Other comments? Let's proceed. Rebecca, please?

PROF. DRESSER: This is somewhat related. On page 5, the first two paragraphs or second two paragraphs, there is a lot of discussion about this as a cell that could become, I mean, implicitly a baby and, I guess, this is somewhat related. It struck me that we do not really know that. I mean, it is -- we do not know whether it is a potential human life. Based on other animal work it might be but they have been having a lot of problems trying to do this with other primates so in a way it is almost saying underlying argument is, well, we should not find out whether it is potential human life, that is whether it could become a child because -- in part, because it is potential human life.

Whether this, whatever it is, this totipotent cell can become a human being, I do not -- you know, science has not investigated that and we are sort of deciding whether it ought to be able to. So that just struck me as a little odd.

CHAIRMAN KASS: Well, Gil, is that a hand? Go ahead.

PROF. MEILAENDER: Yes. This is really to come back to Michael's point. I just wanted to ask in connection with his what -- Michael, what would the difference in the capacities be between the synthesized totipotent cell and a fertilized egg?

DR. GAZZANIGA: Well, the idea, of course, is that one would have the diploid representation of the contributing adult only and the fertilized eggs, of course, would share hereditary information from the man and the woman but maybe connotatively what you are suggesting, to pick up on Rebecca's point, is that we do not know yet how that will pan out, how that totipotent cell will work where there are lots of problems for the human. There are lots of problems in current animal research but that is separate. The distinct difference is, as you know, the genetic make up of the two.

PROF. MEILAENDER: Well, I understand that.

DR. GAZZANIGA: Yes.

PROF. MEILAENDER: But if I take your point, either -- you know, if there is no difference between the capacities, either I do not see why you are concerned about the terminology of the Working Paper or it seems to me one could never talk about reproductive cloning right now. I mean, if we take your point that we simply do not know in the case of the synthesized totipotent cell whether reproduction can take place.

DR. GAZZANIGA: I do not see the problem. Synthesizing a totipotent cell for the purposes of developing a blastocyst is an accurate description of what is going on.

CHAIRMAN KASS: Yes, but look --

DR. GAZZANIGA: And it is not an embryo in the sense of how embryo is defined in the medical and scientific literature.

PROF. MEILAENDER: But it could not be for the proximate purpose of reproduction in your view.

DR. GAZZANIGA: No.

CHAIRMAN KASS: Look, we have got to separate the question of the purpose from the deed.

DR. GAZZANIGA: Right.

CHAIRMAN KASS: And, look, totipotency is a description. It means to describe the powers of this cell. To call it a totipotent cell is to speak about what that cell can turn into. Correct? I think Gil Meilaender's question rephrased is wouldn't you want to say that a fertilized egg is a totipotent cell? That is whatever it means to be a fertilized egg it is a totipotent cell, i.e. it has the capacity to turn into an entire organism.

DR. GAZZANIGA: Absolutely.

CHAIRMAN KASS: So the question Gil Meilaender asks is put again from the point of view of potency, from the point of view of capacity, what is the difference between the zygote produced by fertilization and this synthesized cell produced by somatic cell nuclear transfer, are they not totipotent in the same way? Let's not call them embryos. What is the difference?

DR. GAZZANIGA: Well, they are both totipotent, yes.

CHAIRMAN KASS: They are both totipotent?

DR. GAZZANIGA: Yes.

CHAIRMAN KASS: And in the same way?

DR. GAZZANIGA: No, well, not in the same way because they are made up of a different genetic composition but they are totipotent as defined by the ability to grow into a full organism. Yes, if you want to limit the -- yes, sure, that is it.

CHAIRMAN KASS: That, it seems to me, is the point.

DR. GAZZANIGA: Yes.

CHAIRMAN KASS: And I think that whether -- that the -- the textbook biological definition of embryo as from fertilization to -- I have forgotten, is it two months or eight weeks when they start calling it a fetus? There is something arbitrary about that and it seems to me that what you mean humanly speaking when you are synthesizing this is do you or do you not have that which can turn into an adult? Does it have the potency if it works? Now Rebecca's point is still here but, if it works, is not the product of somatic cell nuclear transfer identical to the product of fertilization in this respect, mainly both of them, if things go well are capable of producing an adult of that species? And, therefore, to call one a totipotent cell and to call the other one an embryo or a zygote might be technically correct but it would be to substitute a certain technical meaning for the human import. The human important is if they are totipotent they are both the same.

DR. GAZZANIGA: Well, I hear you but creating a living cloned human embryo is loaded connotatively and everything else, and to say synthesizing a totipotent cell is the accurate way of describing it -- now the interpretations and ethics of that event are all subsequent to getting the initial definition correct.

CHAIRMAN KASS: Okay. Let's scrap "created for synthesized." Living --

DR. GAZZANIGA: Well, you do not -- that is redundant because you have "potent."

CHAIRMAN KASS: I am sorry.

DR. GAZZANIGA: I think "living" is redundant.

CHAIRMAN KASS: No, let's --

DR. GAZZANIGA: Cloned means in this context --

CHAIRMAN KASS: Cloned refers to the genetic relation to --

DR. GAZZANIGA: Right.

CHAIRMAN KASS: Right. And then the question is what to call the product.

DR. GAZZANIGA: It is not an embryo.

CHAIRMAN KASS: What is it?

DR. GAZZANIGA: It is a totipotent cell.

CHAIRMAN KASS: What does that mean?

DR. GAZZANIGA: The -- what you are suggesting is that we abandon the current medical definition of an embryo. Now maybe you want to do that but that is a new usage and by use of the usage it takes on it will be entered into subsequent dictionaries but right now an embryo refers to a fertilized zygote.

CHAIRMAN KASS: Alfonso?

DR. GÓMEZ-LOBO: What you are saying I do not doubt for a minute but the problem is this, that all language is invention. I mean, all language is a matter of agreement, of an agreement of sorts. In some cases language is developed naturally and for some strange reason there are people who called doors "puertas," right? But in medicine it is usually an agreement probably made, you know, as the profession developed, et cetera.

Now it is true that the way the term -- the word "embryo" is used now it does not cover clones but the reason for that is that it had not been necessary until this point. So I really do not see a problem. I mean, as long as we are clear that there is a parallelism going on there, I do not see the problem with calling "embryo" the organism that develops from a cloned cell.

In fact, I think it is interesting to do this, to imagine for a second Dolly. Let's imagine Molly being a normally conceived sheep and we would have to ask ourselves, well, what happened in one case, what happened in the other case? And there is going to be a phase called the "embryonic phase" I suppose, which took place in both of them.

So if Molly got to be the adult Molly and Dolly got to be the adult Dolly, I just do not see that there is a decisive difference there.

Thank you.

CHAIRMAN KASS: Irv, do you want to get in on this?

DR. WEISSMAN: Sure. So, I think I have to agree with part of what Michael says that, in fact, it is a totipotent cell in the terms of embryology. That is it can give rise to both the embryo and the surrounding membranes that allow implantation. I suppose the important part of this would be is if you could create such a thing by some genetic trick or other trick which could not give rise to say the trophoblast, then it would not be officially a totipotent cell or, therefore, capable of being an embryo because it could not implant.

So I think it is important to try to have very clean language that is free of even convention because I would wager that if we all sat down here and I asked you to draw an embryo and pass it in to Leon -- I am not going to ask you to do that -- but I am willing to bet you that there would be a wide diversity of drawings of what an embryo is with lots of confusions about what a fetus is and so on and so on. And because these are images that are in the minds of people who have to make decisions, for example, in Congress or in the Executive Branch, it is really important to get this part clean if you can.

So I am very worried again about language and I will talk about the second definition when we get to it.

CHAIRMAN KASS: Please, Paul, go ahead.

DR. MCHUGH: I just want to support Michael in what he is saying because I am concerned that we have already made decisions when we begin these definitions and I would reword the classification here in answer to Gil to say that using the term "totipotent" is to fundamentally discuss a genus and distinguishing a zygote from a clone is to talk about a species of cell.

So all species belong to the genus totipotent. They are distinct as zygote and clone in the way they came about and in their essence fundamentally and that from those essences different ways of handling are going to -- different ways of managing is going to occur.

CHAIRMAN KASS: Gil?

PROF. MEILAENDER: If you could keep that synthesized totipotent cell that is a clone alive for four weeks, what would you call it?

DR. MCHUGH: That is an interesting question. I had not thought about what I would call it but I might call it a synthesized embryo.

PROF. MEILAENDER: If you could keep it alive for nine months, what would you call it?

DR. MCHUGH: Well, that is the issue that comes with the eventual use of these products.

PROF. MEILAENDER: No.

DR. MCHUGH: For which we are eventually going to want to speak.

PROF. MEILAENDER: No, it is the issue about what capacities it has from the start.

CHAIRMAN KASS: I think that is absolutely crucial. The uses to which it is put do not determine, do not alone decide what it is and what its capacities are. I think it is important. I mean, I understand. I understand the concern that if you ask lots of people to describe an embryo they think of a baby. Okay. That is a problem. On the other hand, if you talk about totipotent cells, people think that this has no capacity to become a baby and I think the force of the questions that Gil and I are raising is -- there is no -- there was no intent in the paper to try to find language that would carry the moral argument in advance. The point of the paper was to try to find terms which one could then go on and have the moral analysis about.

DR. MCHUGH: I accept that motivation. I am just saying that maybe enhancing the distinction between genus and species here might help us ultimately in our decision. I absolutely agree that the thing was written in an effort to not preclude a particular position but perhaps it has inadvertently and we should talk about that.

CHAIRMAN KASS: Other comments? Charles?

DR. KRAUTHAMMER: Could I jump to where we would end up in our discussion here about what we would call the two kinds of cloning because I think that is the issue that we are trying to face? We agree calling one :reproductive cloning," the question is what do we call the other? I noticed -- and I would like to endorse the spirit of what Stephen Carter had in his e-mail in which he said, "We ought to search for the most neutral possible term."

I think that would enable us all to agree and I think it might also be a contribution in the sense that if we were to issue a paper whose title were this formulation that might actually have an effect on what terminology is used in the future. We may or may not succeed if we invent new terminology but we will be read and we will have something that will be in the public eye and we might actually have an influence over the terminology.

My problem with Stephen's suggestion is that Type 1 and Type 2, I suspect, simply would not take. What I would like to offer as an alternative would be one of the four terms used actually in the National Academies paper. They listed four possible words. They chose one. They listed "nonreproductive therapeutic research," and the fourth was "somatic cell nuclear transfer," which they then adopted.

I would offer as one that I think might be able to command consensus, "nonreproductive." It avoids a lot of the connotations that we would be arguing about. It is simply descriptive and by simply being a negative of the one on which we agree, I think it would allow a neutral way to express what we are talking about in the same way that when we talk about history and we have no idea what to call a period, we call it a post. Post-war or post Cold War because that is all we know is what happened before and we will decide later what it really is when the era has achieved an identity.

So I would say that at this stage of our discussion it might be useful to adopt "nonreproductive." The reason I would be hesitant to adopt "therapeutic" is because I think it would meet some resistance and I would offer two reasons why. (A) we are not sure that in the end it would be therapeutic. It is only hypothetically so. And, secondly, it is not therapeutic for the organism of which we are speaking.

If my brother decides he wants to offer me a kidney, I am lacking all of mine, he decides he will offer me one of his kidneys and he undergoes a nephrectomy, I am not sure -- I think it would seem odd if we called it a therapeutic nephrectomy. It is not. If he had a renal cell carcinoma and had a nephrectomy it would be a therapeutic nephrectomy but if he is a donor it is not going to help him in any way but it is going to help me, I think it would be an odd usage.

So I think if we adopt "therapeutic" we would either have to it with quotation marks or without. In either case we would have dissent on the panel so I would throw out as a suggestion that we use "nonreproductive" as a way to square the circle.

CHAIRMAN KASS: Charles, are you going to solve the problem that Michael has left us with? You see Stephen Carter in his memo still uses this contested word "embryo." Where is it? I just gave it away. I have it here. "Type 1 cloning would be creation of a human embryo for the purpose of medical research or treatment. Type 2 cloning would be creation of human embryo for the purpose of creating a postnatal child."

We would still be in the position of having to say what we mean by both of these things. The cloning simply refers to the relation between the product and the progenitor. That is not hard. That is -- and then the question is how to describe what this means.

DR. KRAUTHAMMER: I am not sure the use or nonuse of the word "embryo" is at the heart of the issue here. I think where the debate has been and where the debate is prejudiced is by what we call the second type of cloning. I think that is what we saw in our last meeting. There was some dissention about the use of quotation marks and the need for the quotation marks was a way of saying that there is fundamental disagreement over the appropriateness of this work.

So I would opt for Stephen Carter's solution, although with a different set of terms.

CHAIRMAN KASS: Stephen, do you want to respond, please?

PROF. CARTER: Well, a couple of things about what we have heard so far. We have two different problems about nomenclature that we are discussing as one. We have a problem of a noun and a problem of an adjective, and they are not at all the same problem, although they are related problems. We are trying to find a noun to describe things that some people think are the same and some people think are different and the difference that the people think they are different is based on is based on not the noun but the adjective that is attached to them.

I should make clear that in my note I am not tied to the term "embryo" in any sense nor am I tied to the terms "Type 1 and Type 2." That was more of an example. But I am concerned a little bit that we do need to have an actual resolution. We cannot talk about this for a while and go on to the next thing because we will not be able to have a conversation, much less produce a written report, if every few minutes we have to begin our comments by saying, "Now, of course, I do not endorse your use of the term this and this and this, and so on."

Now, why are we having such trouble? Well, why do we have trouble with the noun? We have trouble with the noun because I do believe that although some of the nouns that are posed are proposed as being the scientific language and some of the nouns that are proposed for other reasons that behind the proposals for various nouns are substantive positions about what it is that we ought to be doing. And so I think that for those who find all forms of cloning troubling, the natural urge is to reach for a noun that somehow is of better touchy-feely human significance. For those who find the forms of cloning quite different there is a natural tendency to say that the term is less important or rather that the terminology is crucial and that what we really have to do is find the correct scientific name because, after all, no one in the general public is going to know what we are talking about in either of these terms, I suspect, anyway.

In the case of the adjective, we have a very similar problem that we have -- we are still engaged in exactly what you, Leon, warned us against but I do not know how we escape it that we are trying to find adjectives and yet each of us recognize -- I confess this as freely as anyone -- that the adjective we choose will help shape the substantive position.

So the reason -- now let me make clear. I am at this point quite indifferent as to what noun we choose. The noun does not interest me that much and other people feel the noun is crucial. The noun is not that important to me because, I think, whatever noun we choose at least we will have one and we will know what we are talking about, I hope, the same thing, whether the noun is colorful and touchy-feely or whether it is more dry and detached and scientific.

The adjective is very important. The adjective is very important. It is important to a lot of people around the table and the reason, Charles, that I think the "nonreproductive" does not solve the problem is that there were two different kinds of objectives last time, and I want to review what they were.

One objection was to the quotation marks. The objection to the quotation marks was phrased as a concern that if we use quotation marks around these words like "reproductive or therapeutic or nonreproductive," whatever we are going to call it, we are suggesting in some way we do not really think they are the right words and others would say if we do not use the quotation marks it would suggest that we do think that they are the right words.

And, Leon, you suggested, well, you think the staff just chose the quotation marks to show there was a controversy, and I respect that but there is a deeper controversy about the nouns. And that is that remember last time there were people around the table who expressed the view quite forcefully that simply by choosing the adjective -- the two different adjectives we are suggesting a moral distinction that might not exist.

What I was trying to do with words that are taken from -- that have no relation to the debate at all, like Type 1 and Type 2, is avoid that dispute over on the one hand quotation marks versus non-quotation marks, and on the other hand whether we are suggesting through the adjectives we choose a distinction that some wish to challenge. I am not tied to Type 1. I am not tied to Type 2.

I was simply trying to suggest the possibility that we try to find adjectives that do not seek to describe the division. Let the description occur in the definition so that we can have the conversation without having to use words that, whatever word we choose, some people will think it loaded and not wish to use it. That was really my only goal and I want to make clear that I am tied to any of the words I chose. It was a kind of late at night off the cuff memo and yet I think it is important to think about proceeding this way.

The last point: One of the reasons it is important, I chaired a committee at Yale Law School a few years ago, which had nothing to do with abortion but someone raised an abortion analogy and said, "For example, in abortion, we do this and this and this." And the committee fell apart into a discussion of abortion terminology. I mean, just do you use "pro-choice"? Do you use "pro-life"? What is the thing you are talking about? And the committee was not even about abortion. The committee work had nothing to do with abortion, science, civil liberties, anything. It was about some internal procedure and this was an analogy someone had raised but the nomenclature debate there made it impossible to get back to the other point.

I guess I was trying to find a way to allay the nomenclature debate but it may be that what I am being told is that is not possible and if it is not then I would certainly yield to wiser heads.

CHAIRMAN KASS: Gil?

PROF. MEILAENDER: Yes, I was actually -- I mean, I liked the suggestion you made. They are just sort of placeholders which you then defined in a way but our problem is that now our discussion has moved in a direction that it is not clear we could agree on how to define the placeholders. I mean, that is whatever neutral terms we arrive at so I am not sure that that will solve it.

I wanted to say a word about Charles' suggestion and then just ask a question. I do not think, Charles, that what you suggest is going to solve the disagreements because, I mean, what you can do with a thing depends on what it is and how you name it is a way of saying something about what it is, and the real issue is what you can do with these things, whatever they are.

CHAIRMAN KASS: Can I just make a small comment on that? As one who thinks that the right name for this product is "embryo" in the sense that it is a kind of totipotent cell, that it has in a way the same meaning as totipotent cell but it has the human understanding of it and capable of becoming an adult organism. I do not think that that settles the moral question one way or the other. I am perfectly prepared to say that it is an embryo and it does not determine what you do with it. I would, in fact, rather call it that so that I do not deceive myself by sanitizing the name that I am doing something to something that is nothing at all.

PROF. MEILAENDER: Well, maybe the word "determine" was too strong. Obviously, once you know what something is, you can still have a discussion about what it is or is not appropriate to do with it.

CHAIRMAN KASS: Yes.

PROF. MEILAENDER: But deciding what it is will be a crucial matter in arriving at that decision. That is all I meant to say but I just had a question. This is just a question and I do not know the answer. Would it be scientifically inappropriate to call a synthesized totipotent cell an organism and would it be scientifically inappropriate to call a fertilized egg an organism?

CHAIRMAN KASS: Irv, do you want to --

DR. WEISSMAN: I will finish that. Of course, it is not yet an organism until it is an organism. Potential and real are different so if we just leave that. I am worried about the way the discussion is going and I do not want to differ too much with you, Stephen, but what this group is trying to do now is without going into the science of the matter and, therefore, the subtle distinctions in the science, it is trying to make a definition that it could make in a couple of hours, I think, much more easily so I am going to give you the tiniest example without giving my talk.

"Therapeutic cloning" is not at all an accurate term of what is going on and I will talk about it but therapeutic cloning is an invention of commercial enterprises to get you to think that what you are using that for only, and you talked about uses before, is to transplant back into humans for a means of therapy. That is not at all what this is about and I will talk about what it is about but I would argue that you should -- sorry, Stephen -- put it in abeyance, try to talk about what you are talking about as you describe it even though there is going to be quotes and so on, and then maybe later, maybe by noon or so, come back to the question of what Type 1 should be called.

CHAIRMAN KASS: Comments? Bill, Michael, Bill Hurlbut?

DR. HURLBUT: It seems to me looking at the various definitions, and I have them in front of me, from different documents that have been produced that define the embryo, it repeatedly puts the emphasis on the developing organism. What in the working notes has been called "the coordinated process into the governance of an imminent plan for such development encoded in the cell's genetic material." In other words, the cell is an organism in its germinal stage and its activities are those of an integrated and self-developing whole.

When I look at these definitions there are two sides of it. One is how it got to be formed, namely the fertilization. And the second is this concept of a developing organismal process.

Now, admittedly, in the current scientific situation there is a different origin of formation but it seems to me to deny the second part.

And I am a little curious, Irv, how you used the word "organism" a second ago because these definitions include it from the time of the single cell. You implied it was a later development.

In any case the definitions generally put it from fertilization. Organism, if you think of "organism" -- I guess it is from the Greek for tool, is that right? -- the cell itself already has compartmentalized tools so to speak and the emphasis there is on varied things producing concerted action towards an end.

In that sense, whether the thing is formed by fertilization or by nuclear transfer, it initiates the same process. Otherwise, what would be the point of doing it to obtain these cells?

So, in that sense, I do not object to the use of the word "embryo" if we could acknowledge, and I think we all know already that it is a technologically -- it is an embryo with a technologically different origin but it is still an embryo in the strong sense of what we want to define the embryo as.

And every one of the Working Papers that I have read, and I have read them all, uses the term in that sense. I mean here we have listened to three of them.

In the stem cell and future -- and the future of regenerative medicine defines: "Embryo: In humans the developing organism from the time of fertilization until the end of the eighth week of gestation when it becomes a fetus."

In NBAC's report it said, "Embryo: The developing organism from the time of fertilization until significant differentiation."

And the same went on with even Irv's report where he used the term in that way. Let me see if I can find it here.

The point is in any case that we had -- if we are going to balance the objections, Robby is not here but last week he objected to the use of nonreproductive cloning because he said all cloning is reproductive if you take it as the initiation of the human process or human organism.

So I know this is cumbersome and I am not really making this with strong conviction but what if you did allow the word "embryo" to be retained but put the -- so that you had that humanness that Robby wanted present, that potential humanness, if not actual, and put some term like "nonreproductive embryonic cloning" or "research embryonic cloning" so that it is a compromise of all purposes wrapped into it.

CHAIRMAN KASS: Stephen and then Gil?

PROF. CARTER: I think there was somebody next.

CHAIRMAN KASS: Was there? Did I miss somebody?

PROF. CARTER: Well, let me -- one possible way to get around a little bit of this in keeping with what Irv said, as well as what Bill just said, maybe we could do the following: Perhaps what we should do is first adopt a definition of cloning, which could be very much along the lines of the NAS report. Even though it is talking about human cloning, we can take -- we can take elements of the definition there up to the point where it begins to talk about implantation and just stop there.

And then we can draw our distinction, as I suggested in my notes, based not on the claim or denial of a moral difference but rather on the intention of the person doing the act. So, in other words, we first say cloning is this. All right. And then whatever you want to call one type of cloning is that when it is intended for this purpose and whatever you want to call the other cloning is that when it is intended for this second purpose so that we will simply be defining the term "cloning" and then distinguishing two things to talk about based on the purpose for which it is done without making any claim about the what, which is a lot of -- whether there is a distinction in the what's that are created based on the purpose.

And the definition I had in mind, which is not inconsistent I should add with the twin definitions on page 6 of the Working Paper, if you look at the NAS report on page 22, the first paragraph, "Cloning of Somatic Cell Nuclear Transfer," you could stop either after the fifth line or the sixth line. "The egg is then stimulated and in some cases it starts to divide." Or after the next line, "Leads to formation of a blastocyst," period. You could stop there and then make our further distinctions based on the basis of the intention of the actor.

The reason I focus on intention is to avoid for definitional purposes the questions we have yet to confront which we have already spent a lot of time on about moral significance. Otherwise, I am worried that every effort to define it is going to collapse into the very discussion that we are here in order to have and that we have quite sensibly said it is going to take a very long time to work out so that is my suggestion.

CHAIRMAN KASS: Michael?

DR. GAZZANIGA: I was just -- sorry.

CHAIRMAN KASS: Please.

DR. GAZZANIGA: Mr. Chairman, you should be approached in this formal way because it strikes me that why don't we be inventive here and, in fact, let Dr. Weissman give his talk now and we return to this after the talk since there are going to be -- these issues are so much a part of his comments that we just sort of change the order here a little bit.

CHAIRMAN KASS: I am open to that. I am half open to that because his talk is going to be --

DR. __________: Half his talk then.

(Laughter.)

CHAIRMAN KASS: Well, I mean, because the purpose of the next session was really to allow us to ask questions about the whole of the report of which the terminological point is but a small part and I guess if I might -- I mean, here is one of those occasions where it might be true for the sake of getting on with our business that we find a kind of least common denominator, least controversial way of finding terms that enable us to talk and if it comes to that I will settle for it but remember I have given us the kind of charge that we should strive, in fact, to speak about these things in their human significance and not just simply in technical terms.

And one of the things, if I may say in advance -- and the Working Paper was written not with the Academies report in mind -- but one of the things that the analysis of the Working Paper shows is that nuclear transplantation for producing stem cells, okay, the first describes the technique, the how. The last describes the purpose but what the thing actually does immediately is missing. And it seems to me -- maybe the word "embryo" is not the right word.

I am not sure that we can find another one but I think in the light of the question that Gil posed earlier to Paul and in light of the comments that Bill Hurlbut has made, namely that the product, the immediate product of nuclear transfer, is in this limited sense an organism. I do not say it is a person. I do not say it is a human being. I do not say it has rights. I do not even say it has dignity but it is a self-developing whole dividing as a unit and it could conceivably -- it can certainly get to be five or six days old in the animals if they develop these various placental supports that we have been reading about. It could go further.

The ACT people have implanted those clones and harvested primordial kidney cells from it so you can take those things further. That means that whether it is technically an embryo the way the biologists speak about it, it has the same characteristics from the point of view of potency that a fertilized egg does and that is its human importance, whether you use it for stem cells, whether you use it later for producing organs by implanting things in uteri in animals or whether you use it to grow a child.

I think we should not hide from ourselves that fact about what the result of this is and that is not ignorance of biology, that is to treat the biological entity in terms of what it can turn into and what it can turn into not because we want to turn it into that but because that is what its powers are once we have created it. That I think is -- it is a philosophical biological point. It might not be a technical one but I think it is absolutely crucial to understand the meaning of what is being done without arguing the moral questions. That is partly why I think that this cannot simply be done on the basis of the technique.

CHAIRMAN KASS: Gil, and then Paul, and then Irving, I think, wants -- and Rebecca, sorry.

PROF. MEILAENDER: Well, the reason I had asked my question about organisms before was because I -- precisely I was searching for a different term that might somehow encompass the several purposes but I just wanted to note that the Academies report itself -- I mean, I do not know if this is just a case of Homer nodding or what but on page 26, the first sentence of the first full paragraph reads, "The experimental procedures required to produce stem cells through nuclear transplantation would consist of the transfer of a somatic cell nucleus from a patient into an enucleated egg, the in vitro culture of the embryo to the blastocyst stage, and the derivation of a pluripotent ES cell line from the inner cell mass of this blastocyst."

CHAIRMAN KASS: Right.

PROF. MEILAENDER: I mean, it is a natural way of talking about what is going on.

DR. GAZZANIGA: Maybe we should put the quotes around "embryo."

(Laughter.)

CHAIRMAN KASS: Perfectly all right with me. Perfectly all right with me. Who was it? It was Paul, Rebecca and Irv.

DR. MCHUGH: I mean, we ought to put it on the table. What we are wondering about and worrying about is the distinction between words like "stem cell-zygote-clone and embryo-fetus-baby-person." And if given that we have deep concerns of the human significance as you said, the reason I wanted to second what Michael was saying is that I would like to use the word "clone" and in the definition of the word "clone" I am happy to use the word "totipotential cells" and say that is a genus of cell and the species of cell includes zygote, clone, stem cell, which is that is also a totipotent cell, and then we can come eventually to discuss what we mean by the use of these cells to produce embryos, fetuses, babies, persons, and decide how it goes.

It allows us, I think, to get to the purposes with which we are using these issues without already defining the problem.

CHAIRMAN KASS: Thank you.

Rebecca and then Irv?

PROF. DRESSER: I guess, I am just hung up on this. If the genus is totipotent cell then we know that the natural forming embryo can become a person so that kind of totipotent cell can turn into a baby and we do not know whether this other kind of totipotent cell can. I guess part of the question is, well, what kind of evidence do you need to say that there is enough of a chance that it can and that we should put this other kind of totipotent cell into the same category.

CHAIRMAN KASS: Well, we know that in animals.

PROF. DRESSER: So we know in animals.

DR. KRAUTHAMMER: If it were a sheep, would you put it in that same category?

PROF. DRESSER: Excuse me.

DR. KRAUTHAMMER: If it were a sheep, would you put it in the same category?

PROF. DRESSER: Yes, it has been demonstrated. But, I guess -- I mean, as a nonscientist, it seems to me there are so many questions about even different species and also, you know, reprogramming and all these things imprinting. We do not know whether you can create a baby even if -- and we might be able to but I guess it is just -- it is a different kind of level of potential than a naturally occurring embryo.

CHAIRMAN KASS: Let me -- in calling on Irv Weissman to make his own comment, would you address Rebecca's question as well? And with this qualification: If it should turn out that the product of nuclear transfer could grow up to be a blastocyst from which stem cells could be taken, would that perhaps imply even before the thing is tried that it might also be potent to produce a baby if that was intelligible?

DR. WEISSMAN: Sure.

CHAIRMAN KASS: Thanks.

DR. WEISSMAN: So the extensive studies in the animal literature that the National Academies of Sciences reviewed and heard in workshops and discussed and criticized says that in many but not all species tried so far, one can by nuclear transplantation into an enucleated egg, followed by activation, get with a certain probability a one, two cell, four cell, eight cell blastocyst stage of development without doubt.

The probability of a blastocyst in an animal species implanted -- first, I will just say none of them without implantation can give rise to a living organism. That should be clear.

Now once you implant it correctly in the prepared uterus, meaning that it is capable of receiving and implanting, and that is not in every female at any stage, it has to be prepared, once it is implanted the IVF, that is sperm-egg fusion, leads to a viable birth with a pretty high probability. The probability in all animal species where you get success of nuclear transplantation to give rise to a blastocyst that gives rise to a live birth averages about 0.8 percent and, of course, all the way, and that is the reason when I talk about it, you get fetal loss and even maternal loss all the way -- do I feel like I just got censored?

(Laughter.)

DR. WEISSMAN: All of the way. So there is no doubt, Leon, that some blastocysts created by nuclear transplantation will give rise to a full organism that has different probabilities even of life thereafter but clearly it is an organism. So that is not what we are talking about.

I do believe that the popular conceptions of the two words "clone and embryo" are so far from being complete or being even true in most people's minds are such that you ought to reconsider in the purpose not for the purposes of taking away or adding human or human sensibility to it but in the purposes of clarity this body after due consideration could do everybody a favor if you came up with the right terminology and watch even yourself because all of us come in with bias. When I read, you know, in the Working Paper that you have a "being" I understand something different than you might about what a "being" is, including personhood and so on.

So I think that all of us should leave our prejudices at the door and try to get through soon the discussion about what we are describing. I do not think we can do it ahead of time, it is my view. Certainly if you try to move on and say "therapeutic or research cloning" I will just say you better just stop and do as Mike says. Let's have the talk. Let's go through what the science really is and then come back to that issue.

CHAIRMAN KASS: Rebecca, go ahead.

PROF. DRESSER: Well, I had a couple other points but if you would like -- if it is on the same point.

CHAIRMAN KASS: Do you want to respond to this? Please, yes.

DR. HURLBUT: Irv, we have talked about the three components that you would like to put into a definition, the how, the what and why. Was that what they were? So what would you put in? I mean, do you want some reference to biological process, organismal process? I understand why you do not want cloning in. It has a science fiction overextended implication. I understand embryo is a weighted word. Your suggestion, which was not just somatic cell nuclear transfer but nuclear transplantation to produce stem cells, strikes me as describing the why, not quite the what, and it also seems to me that is not the only uses that you could put nuclear transfer to.

So what -- could you tell us what your -- you would like to see included in a definition even if you do not have the words for it?

DR. WEISSMAN: Can I respond now?

CHAIRMAN KASS: Please.

DR. WEISSMAN: After our discussion, what is described when you say "nuclear transplantation to produce stem cells"? Is the general purpose animal or human? Now if you wanted to be absolutely precise about what it is, you would say "nuclear transplantation to produce human pluripotent stem cells." So it is not multipotent or tissue specific stem cells. It is not to produce totipotent cells because that certainly is gone by the time you get to the blastocyst. You do not have that.

The insistence of trying to say, "Well, it is an embryo," certainly it has all of the features of an embryo if it made it that far but it does not help you or hurt you to go on with what actually is going on and it is nuclear transplantation to produce human, if you like, perfectly fine because that is the real process. That is the point of discussion. Pluripotent stem cells. It is -- now, if you want some other purpose, like cloning a human being, that is different than this definition.

DR. HURLBUT: Can I follow up?

CHAIRMAN KASS: Please.

DR. HURLBUT: First of all, the point is there would be many other uses of this nuclear transfer. For example, it could be nuclear transfer for the purposes of studying reprogramming or for the purposes of studying imprinting. So to tie stem cells to it is just one of the possible avenues of use but it seems to me that what is going on here is you are -- in making the definition, the only reason we are here discussing this is not because there is a little lab manipulation going on that goes on all the time in a multitude of permutations and combinations, the reason we are here is because in nucleated this cell with an external nucleus we do not want to enucleate its moral meaning.

So how do you preserve the moral meaning of it, Irv?

I guess that gets down to the question of how much moral meaning does it have but maybe we need to do it backwards then but we do not want to enucleate at least its potential moral meaning with our definition.

DR. WEISSMAN: May I respond?

CHAIRMAN KASS: Do you want to respond?

DR. WEISSMAN: I will just say briefly that we have not even gotten on to the discussion and certainly my panel never discussed the question of whether a nucleus of an egg has moral meaning. This is a pluralistic society. I think there is going to be a lot of different definitions that will come from that and I do not want to get into that discussion.

I agree with you that the science on the way to make it work, nuclear transplantation, to produce human pluripotent stem cells will have a lot of scientific components to it, including reprogramming and understanding what it really would mean if it is possible but I will say again what I have told you is an accurate description at all stages of what happens.

DR. KRAUTHAMMER: Could I ask just one quick question, Leon?

CHAIRMAN KASS: Please.

DR. KRAUTHAMMER: I'm sorry. If I could just ask you assuming you have got a lab that engages in somatic -- in nuclear transplantation for the purpose of producing pluripotent human stem cells, right, and has got a bunch of blastocysts all around the lab, and one night somebody breaks in, he steals a bunch and he implants them in prepared uteri of women, and one miraculously becomes a child. What do you call that?

DR. WEISSMAN: You are going through a lot of steps that we took great care to deal with and I certainly will deal with it in the context of the whole discussion.

DR. KRAUTHAMMER: Are you saying that, in principle, it is impossible.

DR. WEISSMAN: I promise you, I will deal with that issue but to take that away from the whole discussion, I think, is interesting but it is not going to help us out today but we will get there, I promise you. I will answer your question fully.

DR. KRAUTHAMMER: All right.

CHAIRMAN KASS: Charles, do you want to continue?

DR. KRAUTHAMMER: Well, I just do not understand how can you -- how you can define a process by one specific application when we know that there are others that can be applied so it seems to me a definition that on its face is inadequate. If you cannot answer that question that means that we have a definition that does not accurately describe what is happening.

CHAIRMAN KASS: Dan?

DR. FOSTER: I do not want to be judged as wanting to cut off the conversation, though I am in favor of switching the talk, but the late nobelist Medowar (?) said that the only important questions were the questions children asked and one follows from that by saying that in one sense the only important answers are the answers that come to what children ask.

My concern in the conversation this morning, highly technical, begs the point that we have to address the ordinary population consisting of people who have babies and Congresspersons and so forth. And some highly technical discussion of the difference between a zygote and by in vitro fertilization and so forth is likely to lose everything of importance.

I understand that to say "reproductive cloning" and "therapeutic cloning" has nuances that we have discussed today that are very important but my conversations with ordinary people, this is not scientific at all, is that they clearly understand the difference between the common usage that is in the newspapers every day of reproductive cloning and therapeutic cloning.

And what they understand is that one thing that they find, to use a term that is tossed around, repugnant is the idea to make human beings for enhancement and all sorts of things. They understand that, that one is trying to take, whether it is a blastocyst or whatever, to full human capacity and have that human born.

And they also are very concerned with the great hope that stem cells in one form or the other may deal with human disease and they are interested in the scientist dealing with human disease.

Now, there are doubtless moral questions. I, myself, am open. One of my concerns about some of the working papers also is that they imply a conclusion before we ever have the discussion but I think that ordinary people understand what we are talking about and I think they are very interested in that. And I do not want us to get so bogged down either in a written report or in our discussion here that we do not communicate with all the people that count. I mean, we are so worried about whether we are going to convey that we are against all cloning or for all cloning or so forth that we are missing the whole point.

So I would simply say that I would like for us to keep before us the Medowarian principle that we ought to speak accurately but in terms that ordinary people understand. When a baby, when a mother, when a child asks a mother where babies come from, you do not have to go into the precise description of sexual intercourse. You can simply say that this is where they come from. So it is only a plea. It is not for -- it is not to stop the conversation, although I would like to hear what Dr. Weissman says before we use these definitions.

CHAIRMAN KASS: Stephen?

PROF. CARTER: Well, I have no particular attachment to any particular agenda order, however I think that in Dr. Weissman's last comment he made a point that I think is really very important about the pluralism of our society and, indeed, the pluralism is in some ways reflected around the table. We are seeing a number of different views about these issues.

Part of the problem we are facing with definitions, and it is also a problem that we are facing with the debate about the agenda order, is that it is not obvious to everyone around the table that the fact that there is a particular scientific way of addressing the issue means that that is clearly the most accurate way of addressing the issue.

This, in a sense, is what I took to be the burden of Bill Hurlbut's comment a moment ago that to the extent that one believes the point that was very eloquently made by, among others, Robby George last time, to the extent that one believes that moral meaning attaches a contested point but a point that is alive in the country and alive around the table then the definition becomes very heavily freighted.

And to suggested even for the purpose of further conversation or let's move on that we talk as though it does not will then, I think, to a lot of people not merely confuse the issue but belie a very important issue that is one of the reasons that we sit here.

On the other hand, as I said before, it is also true the other way around that if we find a way of talking about it that does suggest moral meaning. Others will say, "Well, but now you are concluding already before we have had the conversation."

And that is why, Leon, despite your heroic efforts and the fact that no one else seems to think this is a good idea. I cling to my original -- not original but my previous suggestion that we define the scientific act (a) and then (b) distinguish according to the intent of the person performing the scientific act and go no further than that in our definitions.

CHAIRMAN KASS: A couple of comments and then we will wind up this session and, in fact, do as everybody wants.

(Laughter.)

CHAIRMAN KASS: Charles, Paul. Charles, was that your hand up?

DR. KRAUTHAMMER: Yes, I did. I would just like to entirely endorse that and I took that to be the spirit of your e-mail that you wrote late that night. It seems to me that we ought not be having our debate on the moral aspects of cloning in this session and try and trying to find a definition. The whole idea of trying to find a definition is a way to enable us to then have our debate in which our terms are agreed upon so I think we ought to go for the lowest common denominator and to find an adjective and a noun that work.

And I would suggest, and I am not sure I would -- I mean, I am not sure how it would work but I had suggested "nonreproductive cloning" as the second type and it is just a way of indicating what kind we are -- what activity that we are talking about without having passed judgment. I mean, there may be judgment read into it but I think it is as neutral a term as we could adopt and it would allow us to have a debate over whether it ought to be allowed or not, which is what we are here to decide or at least to discuss.

CHAIRMAN KASS: Since you have the floor, do you want to say something about the noun? What is cloning, Mr. Krauthammer?

DR. KRAUTHAMMER: I would argue for using the word simply because that is what the public policy debate is about. If we were to adopt some other word I think we would be in some ways dodging our responsibility.

CHAIRMAN KASS: Okay.

DR. KRAUTHAMMER: The bill that the House voted on was a cloning bill. The bill that the Senate is going to have is a cloning bill. If we want to invent a new word that would be heroic but we are not here to do heroism. We are here to do public policy and to discuss the implications of it. Cloning is on the table.

I think both of these activities are a form of cloning and what we want to distinguish is the intent. It seems to me a fairly simple issue. I am not -- perhaps I am missing all the depth here and complexities but the definition ought to be fairly simple and one that we can agree on and proceed to have a debate about whether it ought to be done or not.

CHAIRMAN KASS: Two final comments. Paul, and then Alfonso, and then we will break.

DR. MCHUGH: I really do not need to add much to what Charles and Steve have said. I, also, think that the word "clone" is perfectly fine. I like the breaking down of its definition into encompassing it within its genus and the major reason, and I suppose this is going to ultimately speak to the issues of pluralism and prejudice. I believe that rights are fixed and duties are demanded at some level to embryos, fetuses, babies and persons. And I want to avoid getting to those things, those prejudices or pluralism. I mean, pluralism, you know, is limited. We are a pluralistic society but, by God, we are limited about certain things like slavery and I would like to have our definition at this moment for the use of the word "clone" avoid that.

CHAIRMAN KASS: Alfonso, and then we will take a break.

DR. GÓMEZ-LOBO: Okay. I want to contribute to the consensus at this moment, referring to Stephen and Charles. I think by now in my mind it is clear that we are trying to name three things. Cloning, the activity as such, and then what is intended by researchers, and that can be either reproductive or nonreproductive. So it is really three things and by now I think we pretty much have a denotation for those three things.

Thank you.

CHAIRMAN KASS: All right. Let me see if I understand where we are on this. We are, of course, in the middle and, you know, we start in the middle and we stay in the middle. Hopefully, with a little clarity about where the shore is and what we need to do to get there, invitation number one of many. We have a long time between this meeting and the next. That means that there is a lot of work that has to be done by staff but also I would hope by members. Comments solicited, please, from as many of you as would like on this terminological matter. Creative accounts of the noun and of the adjective. I think Dan Foster's comments also should be kept in mind. We can do our own internal analysis but it is not clear to me that we are simply free to abandon the terminology which is in popular use, though we have been warned that cloning has connotations and embryo has connotations.

I do think that it would be good if in choosing certain terms we do not simply stipulate them but maybe have some discussion about the complexities of these terms for anybody who is interested to be so informed. That, too, is a contribution to the public discussion as it goes on.

So we will hear from Irv Weissman after the break. He will make a beginning presentation. We have questions. I have duplicated and put at your place the questions that were sent to Irv. You might have other ones. And part of what he has to say will, I am sure, influence how we continue to think about the terminological matter but we will bracket it for now and hear about the science and medical aspects, scientific and medical aspects of human cloning. And then this afternoon actually get into the moral arguments without appearing to be doing so surreptitiously.

Fifteen minutes. We will be reconvened at 10:15.

(Whereupon, at 10:01 a.m., a break was taken.)


CHAIRMAN KASS: All right. I have been asked by our audio technician to tell people that they should -- when they speak, they should speak a little bit further back from the mic but still speak into the general direction. It should pick up very well.

We come to the second session of the meeting devoted to a discussion of the report by the National Academies of Science's Panel on Scientific and Medical Aspects of Human Reproductive Cloning. And we are delighted that Irv Weissman, who is the Chair of that panel, is here to discuss the report with us.

We want to do three things. I mean, Irv is going to make a beginning presentation. Council members will have an opportunity to discuss the findings of the report and then take up certain questions of either assumptions or questions of the reasoning. I am not sure that these distinctions are going to be able to be kept from one another. And, finally, we would like to have at least some discussion about Irv's view on the relation between what the Academies has done and what remains for us here in the consideration of these issues.

I would also, if I may, before we start, like to welcome and introduce Dr. Maxine Singer, who is the President of the Carnegie Institution of Washington, Distinguished Scientist at the National Cancer Institute and the Chairman of the Academies CSEPP Committee who oversaw and worked on this report.

Nice to have you with us, Maxine.

DR. SINGER: Thank you.

CHAIRMAN KASS: Irv, would you like to begin, please?

DR. WEISSMAN: Sure.

SESSION 2: HUMAN CLONING 5: NATIONAL ACADEMIES' REPORT
"SCIENTIFIC AND MEDICAL ASPECTS OF HUMAN REPRODUCTIVE CLONING"

IRVING L. WEISSMAN, M.D.

So let me introduce myself first because I think it is important to know where I come from. So my name is Irv Weissman and I am a professor of cancer biology, pathology, developmental biology and biology at Stanford. It just means that the field I am in is a new field and, therefore, it crosses into many disciplines and it has uses in many disciplines.

I work, especially in the last 20 years, on adult stem cells and it happens that we were the first to identify and isolate adult stem cells from any tissue from any organism and you should know that in the course of the research that began with mice in my laboratory I helped co-found two companies. One called Systemics, Incorporated. Another called Stem Cells, Incorporated. And at those companies I was a director or am a director, have an equity position or had an equity position, got consultant fees. Just so you know that there might be unconscious biases or not but you know that.

Now, I should say that none of my companies that I have been associated with, and no current plan of the companies, involves embryonic stem cell research. In fact, if there were an analyst in the crowd he would say, or she would say, what I am going to talk to you about, the permission of nuclear transplantation to produce stem cell lines, if it worked in the narrow sense of the term "therapeutic cloning," would create competition for any commercial effort I am in. So I have been advised of that, too, by people in the company.

So is that all clear so far? Adult stem cells, that is my expertise, it is what I work on but I certainly have worked hard on trying to understand embryonic stem cells.

Now, I am Chair of the panel, as you know, of the National Academies Human Reproductive Cloning Panel and Report. And, I think, the most important thing to say first about that report, both by the charge, by the way we carried out the investigations which were extensive and over a long period of time, and in the report we published we did not look at ethical issues or moral issues or religious issues or political issues. We never discussed them.

Our charge was to look at the scientific and medical, and if medical practice were to be involved, the use of human subjects or human participants in research issues only. Our objective was to try to report to society-at-large what are the facts about either human reproductive cloning or nuclear transplantation to produce human pluripotent stem cells to give you and Congress and others in society that data so that you would be informed about the debate.

Now I should say, since you mentioned that Congress has passed a bill, they passed a bill without the benefit of scientific or medical information. I am sure if you look back at the debate, it did not include what the two Academies' reports are. The first one headed by Burt Vogelstein on stem cells; the second headed by me on human reproductive cloning.

Now you will know if you look carefully at the report that we examined and heard testimony about all of the many animal experiments to produce reproductive clones; that is to produce whole organisms to be born. And what we learned is that in every animal species, whether it is the beginning of the trial or experiments done even most recently, that using nuclear transplantation to give rise to a blastocyst that is implanted in the uterus with the intention of making a living newborn or a living organism that that failed at virtually every step of the way.

Now, you also know that both by IVF and by natural reproduction that there are miscarriages that occur and usually they occur in the first trimester. These failed with a high rate throughout the pregnancy and the consequences of a failure late in the pregnancy did have some morbidity and mortality for the mother that carried it.

There were also defects in placentation, making of the placenta, and also large offspring that developed from it and each of these had morbidity and mortality. Of the blastocysts implanted, on average, 8/10ths to 9/10ths of a percent of them made it to parturition, birth. And even then, many of the newborns died because they lacked the ability to breathe or carry out other functions and those that lived for a long time are coming down with defects that may or may not be attributable to the nuclear transplantation method.

So given that what we learned in many species is likely to occur in man, we decided that that was not ready for prime time. So now I will read just the recommendation itself, not all the preamble.

"Human reproductive cloning should not now be practiced. It is dangerous and likely to fail. The panel, therefore, unanimously supports the proposal that there should be a legally enforceable ban on the practice of human reproductive cloning.

"The scientific and medical considerations related to this ban should be reviewed within five years."

Now, go back. "Scientific and medical."

"The ban itself should be reconsidered only if at least two conditions are met: (1) a new scientific and medical review indicates that the procedures are likely to be safe and effective and (2)..." which we did not do "...a broad national dialogue on the societal, religious, and ethical issues suggests that a reconsideration of the ban is warranted."

We did not recommend that if it was safe and effective that it should be instituted, that is unfortunately, as I see some of the questions, a misconception and maybe it is our miscommunication but I am going to clarify it here.

Next: "Finally..." this is still part of the recommendation. "...the scientific and medical considerations that justify a ban on human reproductive cloning at this time are not applicable to nuclear transplantation to produce stem cells. Because of the considerable potential for developing new medical therapies for life-threatening diseases and advancing fundamental knowledge, the panel supports the conclusion of a recent National Academies report..." that's the Stem Cell Report, the Vogelstein Committee "...that recommended that biomedical research using nuclear transplantation to produce stem cells be permitted. A broad national dialogue on the societal, religious and ethical issues is encouraged on this matter." And I should say, this also was unanimously approved -- this recommendation approved by the committee.

Now I want to, therefore, say that from our point of view, we want -- we recommend a legally enforceable ban, and that is really important because, like many laws, we expect the ban will have an effect on society and those who would attempt to break the ban, rogue scientists you might call them or rogue clinicians or other groups that want to do it, that they would face whatever penalties a legally enforceable ban no matter where they are. So we wanted to make sure that we were not limited to those people who were under the purview of federal funding or under the purview of the FDA. We wanted it to be in the United States and to be clean. It was the line in the sand.

I do not believe we could have moved on to the next recommendation if we did not draw that line in the sand.

Now, for me to get into the terminology issue, I want to get it a little bit into the science, and I am going to apologize. I am going to get up like a professor and show you a figure and talk you through it, and you do not have that figure in front of you but Debbie Stein has assured me that by this afternoon you will have a copy of that figure.

Right, Debbie? You do not have that figure?

DR. STEIN: It is very close.

DR. WEISSMAN: It is close but I want to use this to explain what is going on.

It is like Figure 2 but it is not the same. You could write in the notes what I am going to tell you.

Okay. This was Figure 1. So just so you know, and I am sure you know it better than I even by now that if you enucleate a human egg or in the animal circumstance an animal egg, so you move the chromosomal material, you can transplant into it a whole somatic cell or the nucleus from a somatic cell from some part of the body. And in some frequency when you electrically stimulate that egg, some of them go on to form the blastocyst stage of embryo development, the pre-implantation embryo.

Of course, the fertilized egg is an embryo. The two cell stage, the four cell stage. And if you implant that in the prepared human uterus, which is a complicated procedure to prepare the female who will be the recipient requiring medical treatment and medical personnel, in an operating room setting -- and you will see why I am going to get there in a minute -- if it implants, it can go forward.

At about the time organs begin to form in a very vague way definitionally, it transitions from an embryo to a fetus. The common perception, I will just say to you, and you know it, when you ask somebody in society to draw what an embryo is, they usually draw a fetus, not a single cell or a two cell or a four cell. So that is just a problem that we all have to deal with is that the popular conception of what an embryo is, is not necessarily even close to the facts that are at least defined by embryologists.

So now let's talk about the nuclear transplantation technology. So here now the nucleus can be from any somatic cell. Let me back up just for one second. President Bush's recommendation, edict, whatever you want to call it, on stem cell, embryonic stem cell research has given to the scientific community the possibility to do research on as many as 64 embryonic stem cell lines derived from blastocysts, over there, from spermate fusion, excess blastocysts in in vitro fertilization clinics. That does not represent genetic diversity of humans and if one is going to do even research based on this you would want wider participation by all elements of society, humans genetically so you would understand.

So, one reason to do nuclear transplantation into an enucleated egg to create the blastocyst stage of development from which you derive inner cell mass cells that grow as pluripotent stem cells is to have a broad representation of cells to understand normal human cellular decision making as you go from a pluripotent stem cell, which can make any tissue in the body but does not have the capacity to make a whole placenta or trophoblasts that are involved in the placenta. So this is the only totipotent cell that can make both placenta and embryo, placenta and the developing embryo but after you get this stage. It cannot do it on its own and so it is a pluripotent cells. It can give rise to germ line and to somatic line.

Now, we know next to nothing about the processes that a pluripotent stem cell will turn into say a blood forming stem cell or a nerve stem cell or a muscle stem cell or so on. So it is a legitimate avenue of research to understand those processes with human cells that you could get analogies in animal cells but in the very end to understand the real decision making ourselves, which are crucial to understanding a number of developmental defects that could occur, would be to use a broad diversity of human cells.

Now, if -- and this is a very important point for at least the discussion. The nucleus could come from a normal person or the nucleus could come from somebody with a heritable disease. Everybody in this room, me included, contains genes which give a certain predilection for a human disease, and they are common diseases. Cancers, cardiovascular diseases, neurodegenerative diseases, both kinds of diabetes have a genetic component, and so on, Lou Gehrig's disease.

Now, the particular mutation that anybody found first, say for Lou Gehrig's disease, it is an enzyme called superoxide dismutase, when you have a defect in that, many, if not most people who have the disease, have that defect but not everybody who has a defect in that particular gene gets that disease. So if you want to have a real understanding of that particular disease or the other diseases I talked about, you would need to know all of the heritable components that come together to give rise to that disease.

Now in the human that has that disease, the components came together. So having a body nucleus cell would allow you to make pluripotent stem cell lines to study that disease process.

Some diseases, almost certainly all cancers, have something that goes beyond what you inherit. You have what is called "somatic mutations." Janet Riley is famous for finding somatic mutations that cause human leukemia or at least are involved in an important process. We also studied that in animal models and I can tell you that there are many successive mutations that have to occur. Only in that disease cell, only in that patient do you have the life history that led to that disease. There is no animal model close to this. And understanding how that nucleus, making a pluripotent stem cell line, could lead to the differentiation of cells, for example breast cancer, colon cancer and so on, would be a boon for science. There is no doubt about that.

Now, once these kinds of cells are allowed to differentiate, in many cases you can transplant them into a mouse and show in the context of normal development what goes right or what goes wrong. So the full uses, therefore, of nuclear transplantation for this kind of biomedical research includes normal subjects, heritable disease body cells and the nucleus of the disease cell itself.

If that is permitted, I can tell you that many, many of the best and the brightest will want to study that because it gets you closer to the truth of what is going on rather than the other reductive processes that one uses to try to get at the truth of what is going on. It allows you to look directly rather than by correlation.

Now, since these cells can be made and shown to be made in the tissue culture, many people, and of course companies, say that nucleus coming from that person has the same genetic material and, therefore, could be transplanted to repair defective, degenerated tissues. That is called "therapeutic cloning." That is the only place that therapeutic cloning, the word, fits in. That is why even though I agree completely with you about the popular sense of this, we need to come to the right terms because after a while what this group does, what the government does, what the national societies do to change the terminology will lead to a terminology that will be learned by the popular group but to say this is the only use is to, I think, skew the understanding of the broad importance of this kind of science if it is permitted. Okay.

And I should say even if these cells were here tomorrow, a lot of research would need to be done to make them transplantable entities. And in the -- for full disclosure, I should say that when you put the nucleus in from a somatic cell, the mitochondria still come from the host.

Mitochondria in every species so far are genetically diverse so that between two individuals, Janet's, for example, a particular enzyme like cytochrome C will have maybe one or two different amino acids by mutations that are still functional but our immune system, especially the so-called T cell components of our immune system, look -- scan those small peptides as they are presented on the surface of a cell to make an immune response.

And in mouse studies it is clear that those genetic differences can lead to a mild but certainly effective transplant rejection and so immunosuppression, mild though it is, will be required for that.

So, I think I have given you all the provisos that science can put in and I want you to know that if a ban or a moratorium occurs that blocks the fundamental research in understanding human disease development or therapeutic cloning, clearly promising avenues of medical research will be closed down. And, although I will get to it again in a couple of minutes, this group has a unique responsibility.

On the one hand, as you say, this might be a blastocyst with a tenth percent probability. Right? And that you are judging for various reasons whether that should retain the capacity to stay alive if it was created or in that case when it was naturally created or by in vitro fertilization. So you have a responsibility there. One that my committee did not even address but there is another responsibility that all physicians have taken an oath, and that is to try to be able to treat their patients.

And so I want to say that I believe, and I will give you an argument in a minute, that this is an equal awesome responsibility. Those who make the judgment that this research is banned take the responsibility of whatever medical treatments could have derived from it. There is no escaping this. All of us have that same responsibility. Just so we are all on the same page for that.

I will just take another minute to finish.

So what will be lost if there is a ban? I am going to use only one example, which was a hotly debated example in the '70s, as my precedent and you will find your own precedents. As you know, in the '70s the ability to put two pieces of DNA together became possible. Recombinant DNA. And it was hotly debated for many of the same reasons and, in fact, by many of the same people that this was creating life. It was creating a life form that had never existed before and the kinds of issues, I am sure, you are dealing with came up then.

The scientific community, notably Maxine Singer and Paul Berg, had a conference in Asilomar in 1975, I believe it was, I was there, where the scientific community said, "Let's wait for a minute and let's look at the possibility that something bad could happen from this at least that we could assess directly."

And from that a regulatory agency, the Recombinant Advisory Committee, was developed that looked at and regulated and, in fact, passed on all the plans to do recombinant DNA research.

There is probably not a person in this room who does not know somebody whose life has been made better or saved by the products of that recombinant DNA research. Erythropoietin, all kinds of cancer patients, dialysis patients, GCSF, the way to make stem cells come out of the bone marrow into the blood and do transplants which inarguably have saved lives by prospective analysis and clinical trials, the interferons, the antibody Herceptin for breast cancer, retuximab, and so on.

So I do not think it is arguable that if there had been a ban on recombination DNA research that there would not have been a loss of lives and many of them that could have been saved. Now I know that is going to be on my committee but I am just trying to say to you these are the facts. These are what you must know because the responsibility you are going to take to block a line of research could have that outcome and, of course, it can and probably will go forward in other countries. And then physicians here and the government here will be placed in a very unusual situation of what do you do when a cure comes from that kind of research and they want to import the cure to Americans?

What do you do as a physician, as a practicing physician? Would you deny your patient that treatment? I think you are going to have to consider that. I am not going to come down on it other than what seems to be apparent.

Now, many times the issue has come up that if you make the blastocyst in a research laboratory, what is to stop a rogue scientist from secretly putting it in the uterus of a woman?

That is what you said to me, Charles.

So I am going to try to deal with that issue. It was the reason that we needed to have a legally enforceable ban to stop that because we recognized we had testimony from three groups, two or three of which were going to go ahead no matter what we said and that was a fear.

So let me just say for those who have not participated in the isolation of eggs, the implantation of the blastocyst into a woman, this is not a single person's job. So for the safety of the person who is going to receive the eggs, of course, the -- I mean, the blastocysts, the blastocyst has to be grown in a sterile environment. The transplantation involves a medical team. It involves a woman who has to have been prepared hormonally for it. It is a surgical procedure to put it into the place that will go into the uterus and it involves anesthesiologists, nurses, doctors and so on. It is not something that a single rogue scientist can do in hiding.

Now, to the extent that one is governed by law, there are a lot of people and a lot of places that would then fall under the jurisdiction. It would be a hospital or a clinic or whatever. It would be very difficult, I would say, to do this and, I still say from my point of view, if you have covered it by law, you have covered it. We could argue, and you will argue long after I am gone, what about that rare rogue one who will just go all the way?

So that is my prepared remarks or actually unprepared remarks of my reflections of what the committee did. If you would like, I could go to some of the questions you have or we could just stop here and have open questions and then come back to the questions that you have written.

CHAIRMAN KASS: Let's -- Michael Sandel and Jim, let me make the suggestion -- I mean, Irv has -- you do not mind my saying have gone beyond the findings to speak about additional things towards the end, so even a way maybe to provoke comments about that as well. But I think if at least the beginning part of the discussion we could try to get some help such as we need it about the findings of the report proper and then move on to other things but I do not want to prevent people from going with it like Michael I saw and then Jim Wilson if I am not mistaken.

PROF. SANDEL: I have a scientific question and then a terminological one. The scientific question is could you tell us, based on what is currently known in the scientific community, what are the advantages of embryonic stem cell research as against adult stem cell research and how do those compare with this technique that was written up recently in the paper where an egg has been made to divide with our fertilization such that it might generate stem cells but does not have the potential for life?

DR. WEISSMAN: So let me go to what is known. And here I am going to try to adhere to a standard that journalists have recently, not all but many have crossed the line. Usually when scientists want to evaluate something scientific to know whether it is true there are two preconditions. One, of course, is that it is published in a peer reviewed journal so that other scientists can look at it with different viewpoints and look for holes in it and look for different interpretations and so on so that it has really gone through the wars before it gets published.

And then I still do not believe it, and most scientists do not believe it, until it has been independently verified by at least another laboratory as being something true.

Given those, we have nothing that adult stem cells, human or otherwise, would match the requirements here and I know that New Scientist magazine, not a scientific journal, reported unpublished results from a laboratory in Minnesota that would give all of us great hope that you might be able to get cells for therapeutic cloning. I will just say, first, it is not published yet.

CHAIRMAN KASS: You do not mean therapeutic cloning?

DR. WEISSMAN: Not cloning. Excuse me.

CHAIRMAN KASS: Yes, for therapy.

DR. WEISSMAN: Therapeutic outcomes -- I am sorry -- from adult cells. Thank you very much for the correction. All right. See what happens when you shut off, just all the natural words come by and then -- I will try not to shut off the brain while I talk.

So anyway -- and just to make sure, even though it was not published, I asked the inventor, the scientist, whether it would do everything that we described here. And I have a letter, which I do not know if it is published, she sent it to three senators say that it would not -- and I could read it to you if you like but what I am trying to say is that --

PROF. SANDEL: What are you referring to here?

DR. WEISSMAN: That there is no -- as yet, no fully pluripotent human cell taken from adults that will allow you to study normal development, heritable disease development, somatic mutation disease development or perhaps even therapeutic intent of transplantation. It might happen and it might come out, that part of it, but the scientist said, "You cannot fulfill all of these research objectives with that kind of a cell line."

So, I know every day you read in the media, you know, does umbilical cord do this, do placental cells do this, and are hematopoietic stem cells, the guys I study, can they do everything? And the answer is it is not there. It may come out to be there and all of us would be happy if we could do that but it is not there and so one should not make policy on the basis of those kinds of reported findings or unpublished findings.

PROF. SANDEL: And what about the other one, the parthenogenesis one, the unfertilized that has been --

DR. WEISSMAN: Sure. The parthenogenesis will only give rise to cells, of course, from that genetic origin, the mother. So, quite clearly, it will not cover any of those research objectives that I told you and it would limit the therapeutic intent to that mother. So if you needed to have it, you do not have a chance from that. You cannot do parthenogenesis. Okay.

CHAIRMAN KASS: Jim Wilson?

DR. WILSON: Thank you very much, Dr. Weissman. I would like you to clarify for me, a complete nonscientist, some aspects of your report. To be precise, these: You have spoken about nuclear transplantation and described it on your second chart here. Cell -- adult stem cells can also be derived, as I understand it, from fertilized eggs in in vitro fertilization clinics. In your judgment, are there important medical differences or are there likely to be in the future important medical differences between cells produced by nuclear transplantation and cells derived from fertilized eggs in IVF clinics?

DR. WEISSMAN: Yes. And part of this I probably did not explain it clearly enough first. The IVF clinics have people who come there for fertility problems. It is a very limited part of human genetic diversity. There are not nuclei there that I could go to and say if I want to study Lou Gehrig's disease or cardiovascular disease where you get a heart attack from the result of particular genetic defects, that is not there. So in a very important way those cell lines are only really able to tell you about the normal development from those cells and they will not allow you to do any of the other research objectives. And, of course, if you believed in the therapeutic transplantation, they would only be useful by having the same genotype as nobody who exists.

CHAIRMAN KASS: Stephen Carter and then Frank and Rebecca.

PROF. CARTER: Well, first, I want to thank you for what I think has been a very informative and in certain respects a very enlightening presentation. I am -- I have a question about -- I just want to make sure I understand something clearly about the presentation. I have a question -- I hope this, Mr. Chairman, is in order -- about the recommendation of the panel. Is that something I can ask now?

CHAIRMAN KASS: Sure.

PROF. CARTER: I just want to be absolutely clear that although I recognize the reasons for the different terminology that you chose for the processes you are talking about that up to the blastocyst stage these are identical processes; is that correct? This is the same process.

DR. WEISSMAN: Oh, you mean between this and this?

PROF. CARTER: Yes, this is the same process up to that point.

DR. WEISSMAN: Without a doubt.

PROF. CARTER: There is nothing -- nothing is different up to that point.

DR. WEISSMAN: Nothing is different.

PROF. CARTER: All right. I just wanted to clarify --

DR. WEISSMAN: Except perhaps the choice of the nuclei but there is nothing different between nuclear transplantation with the intent to create a blastocyst to be implanted from nuclear transplantation to create a blastocyst from which you get pluripotent human stem cells.

PROF. CARTER: Okay. Now, I have a question also about the recommendation. In the recommendation the panel unanimously proposed a total ban, a legal ban on what you called human reproductive cloning. It should be -- in five years we should reconsider the medical, that is the scientific basis for the ban. If the scientific evidence tells us at that point the process is likely to be safe and effective, then we should reconsider the ban itself only if there has been a dialogue, a national dialogue that also points to the same direction on the societal, religious and ethical issues.

DR. WEISSMAN: Exactly. A body like this.

PROF. CARTER: Now -- so the point is the ban itself is not based on those issues. You did not consider them. The ban itself is based on the question of whether it is -- the technique is safe and effective. It is not based in any way on these other issues that should also be considered. And so even if it becomes safe and effective, the ban should continue in place in your recommendation until such time as this dialogue has taken place. Is that -- I do not want to misstate it. I want to make sure this is correct.

DR. WEISSMAN: Yes, and I will look around for Maxine or Debbie. That is exactly my reading of our recommendation.

PROF. CARTER: So would it then also be the case that one could plausibly say that a ban on the second form of technology should remain in place until such time as the societal, religious and ethical issues have been addressed since in the first instance even if it is safe and effective medically you still think there ought to be time for a conversation about these other issues. Is that also the case with respect to nuclear transfer that is not intended to create a born human being?

DR. WEISSMAN: Here is where I will differ with you in words but not in the outcome. Since we did not recommend a ban for nuclear transplantation to produce pluripotent stem cells, there is no recommendation for a ban to be in place. Nevertheless, we said clearly, and I think it is the last sentence, a broad national dialogue on societal, religious and ethical issues is encouraged on this matter.

So what we are reporting to you is that human reproductive cloning is dangerous. It is a dangerous medical practice. It contravenes the Nuremberg Code clearly. It contravenes everything that we gave our oath as physicians but there is no such evidence for a nuclear transplantation to produce these cells but as we are scientists and medical, people were not going to impose our personal opinion, which we do not even know. We never polled the panel what their personal opinions were. What we said is we are reporting to you, we are reporting to Congress, we are reporting to NIH, and we hope that this is going to be useful information in your dialogue.

PROF. CARTER: Let me -- I do not want to press much more. I guess, the point -- the question I was trying to ask another way is this: That with respect to human reproductive cloning, the way I read the recommendation of the panel, the question of safety and effectiveness does not conclude the matter.

DR. WEISSMAN: That is true.

PROF. CARTER: Okay. Thank you.

CHAIRMAN KASS: I have Frank --

DR. WEISSMAN: Or of responsibility for those who make the decisions.

PROF. CARTER: Yes, of course.

CHAIRMAN KASS: I have Frank, Rebecca, Gil and Robby at the moment.

PROF. FUKUYAMA: Thank you very much. That was quite helpful. I have two questions. The first is my understanding is that by either of these processes once you get to the blastocyst stage, in a certain sense, strictly speaking, is actually not cloning because the mitochondrial DNA always inherits from the mother's side and you mentioned that that might in some cases lead to the immune system rejection.

Are there other implications of that at further developmental stages? I mean, what --

DR. WEISSMAN: You mean in terms of the transplantation study in the animal models and in vitro ?

PROF. FUKUYAMA: Either. Or in terms of reproductive cloning. I mean, will the difference in the mitochondrial DNA lead to different outcomes in terms of --

DR. WEISSMAN: Well, we discussed the issues about normal embryos are born that have a fit between the nuclear gene products and the mitochondrial gene products, and in some experimental systems there are implications.

PROF. FUKUYAMA: Right.

DR. WEISSMAN: But these are by no means, at least from a scientific point of view, the major cause in reproductive cloning in animal systems that cause the demise of the animals. Many other -- and really not understood -- genetic changes in expression are probably involved in that.

PROF. FUKUYAMA: The second question is I am a little unclear as to what kind of research will happen after the somatic cell nuclear transfer produces the blastocyst and you say you want to study various disease models and then normal development and so forth.

DR. WEISSMAN: Sure.

PROF. FUKUYAMA: Does that invariably involve just harvesting the stem cells from the blastocyst and then doing things with them or does it involve actually allowing the blastocyst to develop, you know, to further stages?

DR. WEISSMAN: Right, right. In my view, and I believe in the panel's view, you are only harvesting the cells from the inner cell mass of the blastocyst. We would be pleased if it were so efficient that you could harvest one cell from the inner cell mass of the blastocyst. That is not here today.

There is no research that has been proposed by members of the panel or that I think are out in society to implant that into a woman that has been prepared for the purposes of harvesting cells or tissues. In my own personal view that would require -- that would also be medical research and would have risks not just for the embryo or fetus that develops from it but for the woman who went through the procedure.

So that is my personal view but certainly everything I have told you here is only done with the pre-implantation blastocyst.

PROF. FUKUYAMA: Would it be possible to develop a blastocyst, you know, outside of a womb?

DR. WEISSMAN: I have heard people say that that is an object for research. I have not myself, and I -- if anybody else has any information -- I have not myself seen an extrauterine development of a complex organism like a vertebrate or a primate beyond the blastocyst stage, although I could conceive it could happen but I think -- our report, by the way, did not go into enforcement that you might want, regulations that you would want.

The California report did and, I think, you ought to look at that report and other people's reports because I firmly believe that the Recombinant DNA example tells us how that should go forward through strict regulation but it was not part of our report.

CHAIRMAN KASS: There are several people, I think, who want in on this point.

Janet, were you going to go somewhere else or do you want on this point?

DR. ROWLEY: It will not be this direct point.

CHAIRMAN KASS: Then I think both Michael and Bill --

DR. KRAUTHAMMER: Could I just ask one question in the follow-up? Could you implant it in an animal and grow it beyond a blastocyst stage?

DR. WEISSMAN: I do not believe -- I certainly do not know of an experiment where a successful full-term pregnancy has occurred from xenogeneic transplantation. I do not even know myself if any have been done but if it came from a human then I think it falls under human reproductive cloning, which I think --

DR. KRAUTHAMMER: I do not mean to bring it to birth but to go beyond the blastocyst stage to a stage where you might get differentiated organs that you could use.

DR. WEISSMAN: Right. As far as I know, that experiment has not been done and I do not know.

DR. KRAUTHAMMER: But under your recommendations it would not be banned since it would not involve harm to any human.

DR. WEISSMAN: Just a minute. How far are you talking about going?

DR. KRAUTHAMMER: I am just assuming you go a few months beyond the blastocyst stage in an animal model. You would not have the problem of the harm to the woman.

DR. WEISSMAN: But you would have harm to the fetus.

DR. KRAUTHAMMER: So that would be your criteria for saying --

DR. WEISSMAN: It is my personal criteria. It is not included in the report.

DR. KRAUTHAMMER: Okay.

DR. WEISSMAN: That is why I think you need to think hard about these issues and put in regulations that are clear.

CHAIRMAN KASS: I think we should -- there are several people, I think, who want in on this same point. Let's see, Michael, Bill, Alfonso and I have one on the same -- because I think this is important to get this sorted out.

Michael, please?

PROF. SANDEL: Just to understand how long the blastocyst would have to exist in order to achieve these scientific effects, the blastocyst is at the five to seven day stage, is that we are talking?

DR. WEISSMAN: Yes.

PROF. SANDEL: How long --

DR. WEISSMAN: In the animal models they are to achieve that stage where you have anywhere from probably 80-200 cells and have fully formed the inner cell mass. There may be a possibility of doing embryonic stem cell before then. I do not know if anybody has but I know clearly that Richard Gardiner has looked in mouse models and if you let it go beyond that stage you can no longer get pluripotent stem cells.

PROF. SANDEL: So that is how many days, that stage?

DR. WEISSMAN: In humans, I imagine it is a few days if it is implanted.

PROF. SANDEL: So if there were regulation that limited in terms of days beyond which you cannot grow the blastocyst either in a lab or by -- no implantation in a human or in an animal, and that you cannot let the -- work with the blastocyst beyond a certain number of days.

DR. WEISSMAN: Let's go with the first one because we know that the blastocyst needs to be implanted to go through the next stages because there are signals that it receives from the uterus itself, from the prepared uterus. And I think if you had a regulation no implantation in human or animal at all, you would cover that.

PROF. SANDEL: And what about a limit in terms of days, not beyond 14 days?

DR. WEISSMAN: In vitro, we are treading on ground where I do not think we have, that I know about, good animal experimentation but I think you could come up with either a stage of development or a time in which it would develop. It would be riskier for you to say a stage of development -- I mean, a time simply because techniques might improve and it might move faster by that time than you would want it so I would, if I were advising you, try to think out at what stage you think the blastocyst turning into a fetus should not be allowed in vitro.

CHAIRMAN KASS: Bill Hurlbut, still on this matter?

DR. HURLBUT: You mentioned a second ago that -- I cannot remember your exact words but you said something about the concern for the fetus which was not part of the Academies report, and as I read the report I noted that in Finding 1 you left any reference to the fetus out completely, and I will read it.

"The scientific and medical criteria used to evaluate the safety of reproductive cloning..." and here one might include this in all your considerations of nonreproductive cloning also. "The scientific and medical criteria used to evaluate the safety of reproductive cloning must be the potential morbidity and death of the woman carrying the clone as a fetus and of the newborn..." this is ES2 "...of the woman carrying the clone as a fetus and of the newborn and the risk to women donating the eggs."

So what was missing in that, it struck me right away, was any reference to safety issues or dignity issues to the fetus.

Now no one is arguing at this point for reproductive cloning, which has a lot more weight on that particular score, but here is my question: We are debating this not because you would deny the tremendous medical benefits that might come out of this kind of research, and I would like to hear more of that because I am very convinced by your arguments that great good could out of this, we are here because we are worrying about its moral -- the moral meaning of what we are doing.

So the question is what does this -- what is this entity that you have created and what could it become and what uses could it be put to? Is this entity created somehow different in character or kind from that which can become a -- which is the early process of a natural human life? Can you convince us in some way that you could do this in a way that would not raise the moral question for anybody who believed that human life started from its earliest initiation at fertilization or zygote production?

In which case, what I guess I am suggesting is could -- can this be done in such a way that there is only partial generative potential so we could look at this as a part apart from the whole? In that sense could it be seen as not quite an embryo and could you do it in such a way that it would render it from the onset not quite fully potential so you satisfy this concern?

Because what strikes me as the problem here is that even if you say you do not want to go beyond the blastocyst that what you have created could be taken beyond the blastocyst. Now I have not read the original papers but there is a lot of reference out there to gestation of a mouse to the point of a beating heart.

And I spoke last week with a professor at Cornell who is working on an artificial endometrial lining that she says she can implant, the hatching takes place, she implants the embryo into it. And she says she is working on a 3D scaffolding that she believes -- and I know this is just anecdotal personal projection but so is most of what we are working on here, Irv. In a sense, we do not know where this is all going in science. I know you will get me on that but the point is we have to think in anticipation of what could happen.

I mean, I would think by reasonable study we could take the embryo beyond the blastocyst stage and wouldn't there -- having made all these arguments for good uses of this blastocyst -- wouldn't there be good arguments for the use of further developmental stages of developed life so that if it did not involve implantation into a woman but into an artificial medium or an animal and so forth that you might gain great benefit beyond the 14 days you have talked about?

What about the development of limb primordia or organ primordia? I have personally seen in the bottom of a test tube a human hand that was taken from human primordia. Wouldn't you possibly have potentials here that you could take this -- what I am getting at is where is your moral stopping point if the science were able to stretch the time you could keep it?

DR. WEISSMAN: So, Bill, I think there is about 15 or 20 questions in there.

DR. HURLBUT: Yes, but they are all about the same thing.

DR. WEISSMAN: Maybe they are, maybe they are not so let me try to at least dissect the few that I remember. First, what you are reading was about the human reproductive cloning part. That is what the finding was relevant to. You know, we tried to stick to what was relevant to us and what we could report to you with assurance because that is what you want your National Academies to do.

Second --

DR. HURLBUT: Was there no concern for morals in that -- for the morality --

DR. WEISSMAN: There was absolutely no discussion because we felt we were not by ourselves competent to discuss the issue that vexes you most. That is morals and ethics of what this is. We did not do that because we knew we would not be the people who made the decision.

DR. HURLBUT: But you made a recommendation to continue it.

CHAIRMAN KASS: Irv, could I intervene? I think you are overstating on that point in the light of what you, yourself, have said. You did take into account, and rightly, as part of what it means to do medicine the -- that aspect of the moral question, which concerns the ethics of research and, in fact, that is really what --

DR. WEISSMAN: Ethics of human subjects in this particular research.

CHAIRMAN KASS: Human subjects research, right.

DR. WEISSMAN: Yes, we certainly did.

CHAIRMAN KASS: Yes, and I think -- if I understood Bill's question, it was -- it could have been framed to ask why when you are taking up the questions of the ethics of human subjects research does or does not a fetus come under that as a subject where it, in fact, does come under that as a subject in the canons of research on human subjects and IRBs, and other places.

DR. HURLBUT: Yes, that is right.

CHAIRMAN KASS: It was not the big broad global moral questions.

DR. WEISSMAN: That is right.

CHAIRMAN KASS: But in terms of the research.

DR. WEISSMAN: And we did not do the big broad moral question because we were not a body constituted to even address those questions, Bill, and although personally people may have wanted to address them we felt it was more important to get the science as straight as possible.

Now as to your conversations with reproductive biologists at Cornell, maybe that is published, maybe not, I do not know but I would just advise you be -- try very carefully when you are going to make policy that will ban or not ban what is going forward that you at least try to adhere not to anecdote but studies that have been done that show clearly the way to go.

CHAIRMAN KASS: Could I -- I think this is an important question not because it bears on the question of the ban but because it bears upon the logic and reasoning that the Academy itself uses and is encouraging us to follow.

I am going to try Bill Hurlbut's question again. It seems to me that the powerful -- it is, indeed, a moral argument of the importance of learning about these disease processes because there are human lives on the line that we want to do these kinds of studies for which stem cells created from -- let me not beg the question -- stem cells obtained following nuclear transplantation offer opportunities not available from stem cells created by IVF and you have made a powerful argument for what we can learn from that.

But then Bill asks, look, what if one wanted, both for the sake of understanding development and also for the sake of maybe obtaining even better tissues for transplantation, to go beyond the blastocyst stage. No one has done that to this point in humans though Michael West's group put the cloned cow embryo back in and took primordial renal cells at a later stage. And we do know that there are immune deficient hosts in which one could, in fact, do cross species -- even intrauterine placement.

So it is not a question about the ban. The question is, is the logic of defense that has been given for the nuclear transplantation to produce stem cells, isn't the logic -- wouldn't it actually countenance the taking of the blastocyst further if it were possible? Not with reproductive intent but with the intent to learn more about pathological development, with the intent of trying to find therapies without -- not going through stem cells but perhaps getting organs and tissues.

I think that was the force of the question. Not should we ban this but did the Academy itself consider other further uses of blastocysts beyond just extracting their stem cells because it is certainly conceivable.

DR. WEISSMAN: So we were asked to look at the scientific, medical and human subject participation in research aspects of human reproductive cloning and how this applies in general to the issue of pluripotent stem cells so it was not part of our charge. We were not constituted in a way that we could have answered that. And, as I said at the beginning, in the middle and at the end, we cede that to broader societal discussions. On a case by case basis as science advances you and other groups must look at these issues again. What we were dealing with are the two issues we bring to you and not other issues.

CHAIRMAN KASS: But speaking now as a scientist, and we will not have you again next time we meet --

DR. WEISSMAN: How do you know? The way that this discussion is going on, I am just about to book an apartment here.

(Laughter.)

CHAIRMAN KASS: Thank you very much.

DR. WEISSMAN: Okay. Go ahead.

CHAIRMAN KASS: Are these thoughts of the further development of blastocysts either on artificial endometria or with implantation, wouldn't that produce interesting new knowledge that would help cure disease?

DR. WEISSMAN: It may or may not.

CHAIRMAN KASS: And wouldn't we want to do it?

DR. WEISSMAN: It may or may not. It was not covered in our report.

CHAIRMAN KASS: I understand.

DR. WEISSMAN: But I would argue to you that if this other issue is one that you need scientific data on and good scientific and medical advice then commission the Academies or NIH or somebody to do that. We did not do that.

CHAIRMAN KASS: I have Janet, Gil and then Robby. I skipped Rebecca. I am sorry. Janet and Rebecca.

DR. ROWLEY: Rebecca was first.

CHAIRMAN KASS: Sorry.

PROF. DRESSER: I have a few questions. One is in the Cloning Report you talked about one ethical concern being the number of oocytes that would have to be obtained for reproductive cloning but you did not really talk about the number of oocytes that would be needed for biomedical research purposes so I wonder -- it seemed to me -- I mean, this Michael West group tried once and they did not get very far so it seemed to me that there would be a number of oocytes required and I know this was not your -- well, I guess it was your -- if that was an ethical concern with this cloning, whatever it is, to produce a baby, isn't it an ethical concern in the research context not only the risks that women would be exposed to but the probability that there would have to be some payments attached? In some sense "competition with fertility clinics," a whole set of issues there. So I wondered why you thought it was important with the one type and not with the other.

DR. WEISSMAN: Sure. So if you look, for example, on B12 of the appendix, the figure -- and I will just describe it for you, you could look at it or not -- the number of eggs required to make the numbers of blastocysts by nuclear transplantation to implant in the uterus with the intent of reproductive cloning to get a single human is massive but the number of eggs required to get to the blastocyst stage from which you could extract cells that would be producing pluripotent stem cells is at least -- I want to get the number right -- at least 100-fold less.

So we pointed out from a scientific and medical point of view that you would need to have a source of eggs to do so and we pointed out that there are syndromes that women have, hyper stimulation syndromes, which I believe have morbidity without mortality but I would have to cede to the gynecologists on that.

So going into the numbers game and understanding the regulations and the institutional review boards that must approve it are all part of what we think should go on from there before it could happen but just from a strict scientific point of view it is orders of magnitude fewer eggs required to create a blastocyst for producing the stem cell lines than from producing blastocysts in sufficient number to have even a viable birth.

PROF. DRESSER: I see. Based on animal work because we have not even gotten to the --

DR. WEISSMAN: All on animal work.

PROF. DRESSER: -- that stage with humans.

DR. WEISSMAN: Right. And we will not.

PROF. DRESSER: I guess the other observation I had was that -- I mean, it really is -- part of your statement finessed what we have to do. I mean, think of we could say, well, if we did not require consent from human subjects then we could learn a lot of important knowledge and if we decide to require consent and other countries do not require consent then other scientists might go to those countries. I mean, the real question is not whether there are important benefits available but on the other side what are the ethical considerations. And whenever we think about the traditional research ethics considerations, as well as some of the things we might think about here, we must accept that we might not be able to get certain knowledge.

DR. WEISSMAN: I certainly agree and the Nuremberg Code, with which I am in full agreement, outlines those kinds of things you would not do simply for the sake of knowledge that involve human subjects. I personally believe it is one of the most elegantly written documents I have ever seen and I adhere to it completely. So does that answer your question?

PROF. DRESSER: Right. It is just that it does not really address the kinds of questions we have to and so --

DR. WEISSMAN: That is right. That is why I do not envy you the responsibility you have.

PROF. DRESSER: Thank you.

CHAIRMAN KASS: Just on this? On the Nuremberg Code?

DR. GÓMEZ-LOBO: Yes.

CHAIRMAN KASS: Quickly then, Alfonso, and then Janet.

DR. GÓMEZ-LOBO: This, I believe, is tangential to the reference to the Nuremberg Code. I would like to understand the central part of Finding 4, which reads, "Participants in any human cloning research efforts require full protection as human research participants..." which I think is on the Nuremberg Code "...although it should be noted that as with fetal surgery, this protection cannot be extended fully to the cloned fetus." My question are what -- how do we distinguish between full and partial protection and, second, why is in one case full protection demanded and in the second case not?

DR. WEISSMAN: Well, we recognize, as you recognize, that the fetus is not in a position to give informed consent. As you know, there are lots of intrauterine surgery to repair defects in human fetuses with the intent of keeping them alive even though they cannot have informed consent for the surgery and the risks of the surgery. So it is within that context I understand that it is partial rather than complete, that sometimes physicians, parents and so on must come together to make a decision that is in the best interest of the life of that fetus.

CHAIRMAN KASS: Janet? Thank you for your patience, Janet.

DR. ROWLEY: I have two questions. I think one of them comes back to your diagram Figure 1 and it has been brought by others in terms of times that these events are -- over which they are occurring and you were obviously uncomfortable about putting a specific time but the blastocyst in the normal course of say IVF, of the time from the donor egg to the development of the blastocyst, that range is known and it is approximately --

DR. WEISSMAN: About five to seven days I am told.

DR. ROWLEY: -- five days.

DR. WEISSMAN: I have not done those myself.

DR. ROWLEY: And I understand that some of the regulations in other countries, the U.K. for example, requires the disposal of embryos after 14 days. Why did they choose 14 days? I mean, I am asking you --

DR. WEISSMAN: I do not know.

DR. ROWLEY: -- do you whether there is a reason to choose that particular time?

DR. WEISSMAN: I do not know why they chose that.

DR. ROWLEY: Okay.

DR. WEISSMAN: Could I just make a small point because I think it is an important point?

CHAIRMAN KASS: Yes.

DR. WEISSMAN: You have been very strong, I hear it, about whether nuclear transplantation with the intent of producing human pluripotent stem cells gives rise to a stage you would call an embryo that could become a human being. So would you believe if scientifically one made a blastocyst that had no possibility of implanting would be an appropriate research venue?

CHAIRMAN KASS: That was part of Bill's question. Could one incapacitate --

DR. WEISSMAN: Yes, I know, that is what I was getting back to.

CHAIRMAN KASS: Yes.

DR. WEISSMAN: So if it were possible to deny the formation of a trophoblast or remove a trophoblast so that there was no chance whatsoever that it could be implanted even by rogues even in that, I think, unlikely finding, do you think that that is fully permissible by this group?

CHAIRMAN KASS: We will have, I think, our first discussion -- real discussion of the ethics of nonreproductive cloning. It is the tail that wags the dog of the discussion of research on embryos all together, which is part of our charge in the whole stem cell question.

DR. WEISSMAN: Sure, but that is the point that I -- that we are discussing now.

CHAIRMAN KASS: I mean, people -- the floor is open if anyone wants to speak to that. Janet, would you --

DR. ROWLEY: I need some more education. So you explained why the presently available ES cell lines are not suitable for some of the kinds of both investigation and potential therapy that you envision or that is possible -- may be possible. And I am ignorant as we look at embryos that are presently in freezers in IVF clinics. It is my impression that some of those may well be used for somatic nuclear transplantation. Is that correct or is that --

DR. WEISSMAN: I do not think so.

DR. ROWLEY: -- that is not --

DR. WEISSMAN: Because I think they have already passed beyond the stage where a somatic nucleus could develop into all the tissues that you want. It would be interesting if somebody had accomplished that, that is by putting a somatic nucleus into an inner cell mass cell that has been enucleated and actually succeeded in making a line. I asked Ian Wilmont and Austin Smith that question, who are the experts in that field, and they said they have tried many times and they cannot make it work yet.

DR. ROWLEY: Because it was my impression that some further attempts were being made to actually use discarded embryos to do just that and you are saying --

DR. WEISSMAN: To do nuclear transplantation?

DR. ROWLEY: -- you are saying that that is not -- as far as you know that is not possible.

DR. WEISSMAN: Certainly, as far as I know, it has not been accomplished and when I talked to the people who are at the leading edge of the field they have not been able to accomplish it, although they have tried.

DR. ROWLEY: Okay. So is it possible, though, to take these frozen embryos and develop ES lines from them comparable to the ES lines that are already available?

DR. WEISSMAN: They would be -- yes, comparable to the ES lines that are available but in no way could they address the genetic diversity of the heritable disease and the somatic mutation issues that I raised.

DR. ROWLEY: Okay. So the reason I pursue this is because a number of individuals have thought, well, one out is to take -- and we discussed this the last time -- is to take the embryos that are currently in freezers around the country and around the world and actually do a number of the kinds of experiments that are -- or the preparations that are illustrated in Figure 2 and that, in fact, we would not need to create new embryos for that because we might have them already and you are saying that, in fact, the nuclear transplant has to take place at a very early stage and, therefore, we do not at present, at least, have such cells available for that kind of research.

DR. WEISSMAN: That is right. That is right.

DR. ROWLEY: Thank you.

DR. WEISSMAN: You know, if you were trying to go the route of having so many human embryonic stem cell lines from these discarded IVF clinics, if you use the experience of bone marrow transplantation to get a probability of a histocompatibility match, that is a tissue match, not a perfect match, believe me, but just a match in the HLA locus. It is about 40,000 required so that is not realistic either.

CHAIRMAN KASS: Gil Meilaender, Robby. Let's see. Michael, Michael, Stephen and Bill.

Gil, it is for you.

PROF. MEILAENDER: Okay. I would like to think about the relation between the Academies report and sort of what we might do in our deliberations because actually I am increasingly confused about what that relationship might be. Let me come at it from a couple of angles. On the one hand, you said several times that there is -- your report is sort of just the science and you abstain from moral or political issues and deliberations.

DR. WEISSMAN: As a group.

PROF. MEILAENDER: As a group, yes.

DR. WEISSMAN: But I am still an individual.

PROF. MEILAENDER: Oh, yes. Yes, I meant the report as a report.

DR. WEISSMAN: Right.

PROF. MEILAENDER: And yet the report recommends political actions like a legislative ban. It uses language with respect to the nuclear transplantation to do stem cells that it should be permitted. It concurs with the previous Academy report that it should be permitted. So that all looks like moral language to me. It appears to be drawing a moral or a political conclusion. That is -- and, therefore, does not seem to me to be significantly different from the kinds of questions we might raise ourselves.

DR. WEISSMAN: Well, let me clarify it then if I can.

PROF. MEILAENDER: Okay.

DR. WEISSMAN: Because it is in the language of the recommendation. "Should be permitted" pending on scientific medical grounds alone the nuclear transplantation technology to produce stem cells. But we said clearly, and it is the last sentence again, that we are not the last word. We are delivering this to groups like you to make that judgment. We did not make that judgment. The only reason that we said a legally enforceable ban recommended, a legally enforceable ban for human reproductive cloning is that when we scanned the regulations that existed and the bodies that had authority to regulate it, we realized there was a gap and so we felt, and I think we felt pretty urgently, that since there were people saying they were going to do that very soon and in the United States, if possible, that we ought to recommend a legally enforceable ban.

Now, of course, what we are doing when we did that was very uncomfortable for scientists, of course, to say that you should ban any freedom of inquiry but we were so -- the evidence was so compelling that a bad outcome would result if it was attempted that we recommend to society -- because we have no power --

PROF. MEILAENDER: Nor do we.

DR. WEISSMAN: -- to develop -- you have more power than we do.

PROF. MEILAENDER: I would be surprised.

DR. WEISSMAN: I expect that you have more power than we do. At least you are talking to groups that could by executive action enforce a ban. We are not.

PROF. MEILAENDER: Okay. But let me just comment on that that it is nonetheless the case that as opposed to simply saying here are some real safety considerations that one might think about in connection with what we are calling reproductive cloning and the rest of you folks are just going to have to decide whether those risks are worth the possible gains. You did actually make a recommendation that I would call moral and political. I mean, I think that is important to see just in terms of thinking about the relation between the Academies work and whatever we might do so that we are not, in fact, doing two entirely different things but that whatever you do does --

DR. WEISSMAN: Yes. Our reading of human subject participant in research in light of the Nuremberg Code and the things that follow clearly stated that that would be something that would go against an agreed upon societal restriction. That is why we recommended it.

PROF. MEILAENDER: Okay. Good. And now may I pursue one other aspects on this?

DR. WEISSMAN: Sure.

PROF. MEILAENDER: From a different angle, a way in which it just -- you know, despite all the helpful information you gave, it still leaves me confused, it relates to our conversation in the first session this morning and that is that it appears, and I think you, yourself, said it in response to a question someone asked about the two diagrams up there that with respect to these two processes called "human reproductive cloning and nuclear transplantation to produce stem cells," it appears that the actual initiating act and the product are the same. The difference lies solely in the human will and choice, the purpose. And "will, choice, purpose" language is once again moral language.

DR. WEISSMAN: Yes. You know, what you are saying and what I could agree with is that an intermediate step of both is the same. The product is not the intermediate step in either. So the product is not the same and I certainly agree "will, intent and choice" we will rule in law -- we will rule on whether one choice or another is permitted or not but stopping at any particular stage is not necessarily going to help us understand the real issues. You stopped it at the stage of the blastocyst because that is really important to you and I understand it. Okay. But that is not the product.

PROF. MEILAENDER: Well, may we pursue this or not?

CHAIRMAN KASS: Why don't you go ahead one more line, one more time?

PROF. MEILAENDER: Okay.

CHAIRMAN KASS: Because I think you are talking -- I think there is some --

(Simultaneous discussion.)

PROF. MEILAENDER: Can we come around -- what is important to me is trying to get clear on this. Can we come around to the question that I submitted -- one of the questions I submitted in advance to you?

DR. WEISSMAN: Okay.

PROF. MEILAENDER: Which I will just read again. You have it. It was that the Academies report discusses two procedures which it says are very different from each other. First, human reproductive cloning and, second, nuclear transplantation to produce stem cells. Suppose we are shown externalized in the laboratory two cloned blastocysts X and Y. We are not told which is X and which is Y but we are told that X is the result of procedure one and Y is the result of procedure two, and we are asked to examine the blastocyst and determine which is X and which is Y. On what basis could we make that determination?

DR. WEISSMAN: Right. And so I would use an analogy, which is based on my background. I grew up in Montana and we grew up with rifles, which we used for many purposes. The rifle is the same as you know, whether you intend to use it to kill a person or for target practice the rifle is the same. That is not the crime. That is not the issue. So it is not visually what you can see or even by genotyping what you can see. The purpose is the important point here.

PROF. MEILAENDER: Well, I think it is a little more complicated than that. If you -- there might be two cases, identical cases in which you shoot to kill someone for very different reasons. One, merciful motives and another different does not alter the fact that you shoot to kill in both cases.

DR. WEISSMAN: Right. And you use the rifle for other reasons, too. I agree with you and there are laws that we developed to protect society against one case and not the other, and we are subject to those laws and you are going to help advise on what laws should be present or what guidelines or what regulations or what bodies will regulate it.

CHAIRMAN KASS: Irv, if I may, it seems to me that -- and maybe it is the fear of impending legislation or interference that colors to some extent the responses that you have made here and on other occasions. I thought -- I thought Gil's question was not somehow intended to embarrass or, in fact, to invite that there is a kind of cryptolegal (sic) judgment that hangs on the back of this. It was simply to make sure that we are clear, whether we are clear about what the -- what the product is (a) and (b) to indicate, and I think he is not wrong about this, to indicate that it is true that the Academy has -- and I would want to say rightly -- restricted its scope to what is within its area of expertise and has taken up those moral questions that belong to the proper understanding of the conduct of medical researchers that to be a researcher is not simply a technical activity but insofar as it deals with human subjects it is understood to be a moral freighted activity and it is, therefore, perfectly proper to do exactly, it seems to me, as you have done.

But I thought that Gil was pointing out that there -- in the first part of his question he was trying to ask what is the relation really between the fact that you have -- that whether you are willing to say so or not, you have engaged in a partial moral analysis insofar as you touched the question of human subjects research and insofar as you distinguish between two kinds of activities in terms of the human intent that also is to bring moral terms to bear on what are otherwise simply scientific or technical things.

I do not think -- if I -- I mean, I have listened to this guy a long time. I know when he is trying to make an argument for some additional purpose and where he is simply trying to explore certain things for clarification because it does really go to the question what is the relation between the kind of medical/moral analysis that you have done because when you do make recommendations or you do pronounce you are going beyond simply saying this is unsafe. This is unsafe as a scientific judgment. Therefore, it should not be done.

It is a judgment of a different sort and I do not think -- there is no reason to be embarrassed about that. That seems to me a service here but the question then is what is the relation between the character of the moral discussion there and the kinds of things that we are doing here, and I think that is --

DR. WEISSMAN: Well, there is a huge difference in that you are charged with looking at all of the critical moral issues. We were charged to look only at in terms of the human reproductive cloning and cloning for the production of stem cells, to look at those issues that would apply to human subjects in clinical experimentation or clinical practice and we restricted ourselves to that and we needed to report to you and to Congress what would be lost if there was a ban also on stem cells and I reported that to you.

CHAIRMAN KASS: I have Robby and then the Michaels, and we will go from there.

PROF. GEORGE: Thanks, Leon.

Dr. Weissman, thank you for your presentation. I grew up in West Virginia and it was a similar sort of culture when it came to guns so I liked that analogy very much and I --

DR. WEISSMAN: And now you are going to use it and you want to stick with it, yes.

(Simultaneous discussion.)

PROF. GEORGE: Yes, I think we can communicate when we talking in these terms we can definitely communicate even though I am not a scientist.

(Laughter.)

PROF. GEORGE: At least where I grew up, and I bet it is true in Montana, people had guns for different reasons and that is part of your point, two of the reasons. One was hunting and the other was collecting. There were a lot of people who were interested in collecting but when someone assembled the gun, whether the goal was collecting or hunting, the product was the gun. The product of the assembly was the gun.

Do you agree with that? It is not a different product depending on the intention, whether it is hunting or collecting?

DR. WEISSMAN: Yes.

PROF. GEORGE: Now the nuclear transplantation is a procedure, right?

DR. WEISSMAN: Yes.

PROF. GEORGE: Okay. It aims to produce a product. Now let's not get hung up on the definition.

DR. WEISSMAN: I will assume that. Go ahead, yes.

PROF. GEORGE: Okay. Down the line that product might be a cure for a particular disease.

DR. WEISSMAN: Right.

PROF. GEORGE: But proximately is it the case that the product is stem cells as such or is the product the thing that has to be produced in order to get the stem cells, the blastocysts?

DR. WEISSMAN: In my view --

PROF. GEORGE: Or is it not settled scientifically?

DR. WEISSMAN: No, no, I will give you my view and then we will say it scientifically.

PROF. GEORGE: Okay.

DR. WEISSMAN: What I told you was that the product of recommendation -- the second recommendation, nuclear transplantation, to produce stem cells describes the product, stem cells. You may choose to say that an intermediate step in your mind is the product, the blastocyst, that is your choice. I am just saying we tried to be as clear as possible what the product was and we said what the product of the first was, the intent to make a human live birth by implantation, and the second to make stem cells not by implanting but by extracting cells. So the products are different.

You may choose in your own mind, in your own description to take an intermediate step, the single cell, the two cell, the four cell, the eight cell, the morula, the blastula. You may choose that but that is not what we described scientifically or, I think, by our language.

PROF. GEORGE: If no blastocysts were brought into being, would it be possible to obtain stem cells?

DR. WEISSMAN: You are asking me is it possible that we could make something short of being a blastocyst? Theoretically, yes. I do not know anybody who has done it. We could, for example, enzymatically remove the trophoblast cells as they are formed or genetically prevent their development. That is not inconceivable. The experiments are not done and are not published but that is inconceivable so, yes, you could get to a point where you make something that nobody would call a blastocyst because it lacks the trophoblast. You could do that. Is that where you are going?

PROF. GEORGE: No, but you have brought me right to where I want to go, and this is the question of the something. You said something that no one would call a blastocyst. So one possibility is a blastocyst. Another theoretical possibility, and I take your point that we do not know, would be something else and it would be from that something else that stem cells would be harvested.

DR. WEISSMAN: Yes, if you could do that experiment, right.

PROF. GEORGE: Okay. But what that says to me, now tell me why I am wrong about this, is that it is unavoidable as a matter of scientific fact and not as a matter of definitions or how I choose to use words. It is a matter of scientific fact. There has got to be an intermediate step. A something from which stem cells are harvested. That something being brought into existence by a procedure called "nuclear transplantation."

DR. WEISSMAN: Mm-hum.

PROF. GEORGE: Yes?

DR. WEISSMAN: Absolutely.

PROF. GEORGE: Okay. When you referred to the -- several times you referred to the blastocyst stage. Tell me if I am right, is that the stage in the development of a determinate organism?

DR. WEISSMAN: Yes.

PROF. GEORGE: Yes, okay. So that after the blastocyst stage if the environment is suitable there would be further development into other stages?

DR. WEISSMAN: Do you mean if by intent you put it into a uterus that is prepared for it?

PROF. GEORGE: Could be accidentally. I mean --

DR. WEISSMAN: I cannot believe it is accidental that you could put it into uterus. Let's be real, okay.

PROF. GEORGE: Well, could you --

DR. WEISSMAN: It is by intent that you put it into a prepared uterus with the intent of having the downstream effects of it, namely for a fertility clinic to make a child.

PROF. GEORGE: I am not interested in the issue of intent right here and I wonder if we can get at the problem without intent. Maybe you can show me that we cannot and intent is relevant to the scientific description but however it happened if the environment were hospital the blastocyst would continue to develop. Right, there is a stage that is the blastocyst stage. I take it this is what you mean by stage. If it is the stage, as you say, in the life of a determinate organism --

DR. WEISSMAN: Yes.

PROF. GEORGE: Okay.

DR. WEISSMAN: Correct.

PROF. GEORGE: Yes. All right. So looked at back the other way, Dr. Kass is now in an adult stage, as the rest of us around the table are, at an earlier point of his --

DR. WEISSMAN: Decrepit.

PROF. GEORGE: Hardly.

(Laughter.)

PROF. GEORGE: -- existence he was in adolescent stage, before that --

CHAIRMAN KASS: Never, I do not believe --

(Laughter.)

PROF. GEORGE: He was wise before he was old.

(Laughter.)

PROF. GEORGE: And before that in an infant stage.

DR. WEISSMAN: Pick another subject.

PROF. GEORGE: Is that right?

DR. WEISSMAN: I did not hear the last --

PROF. GEORGE: But before the adolescent stage and infant stage --

DR. WEISSMAN: That is right.

PROF. GEORGE: -- all the determinate life -- the life of a determinate organism, before that in a fetal stage. Now I do not want to use the term "embryonic" because I know it was problematized, as my colleagues in English literature insist on saying these days, in the earlier discussion but would it be fair to say that before that Dr. Kass was in a blastocyst stage?

DR. WEISSMAN: For sure.

PROF. GEORGE: Okay. Good. Then the only other question that I have --

DR. WEISSMAN: So we have linked him up with all the other vertebrates now.

(Laughter.)

PROF. GEORGE: Okay. And the other question that I had is on this question that both Steve Carter and Gil Meilaender have raised about the relationship between ethical considerations in the scientific and medical ones, I take your point entirely and understand it that there were certain extra medical scientific considerations that you rightly took into account in making that first determination because we have certain international legal and medical standards that have been agreed to and there is nothing controversial in that at all, and it would be irresponsible not to take those into account as providing the necessary ethical premise to be joined with the scientific premises about the danger of this --

DR. WEISSMAN: And it was part of our charge.

PROF. GEORGE: Fine. That leaves me with the second one and that is the one that I am not sure about. It looks to me as though to reach the conclusion that nuclear transplantation to produce a blastocyst for stem cells or however you want to say it should be permitted, and I think I am quoting this accurately, should be permitted. That is to say not forbidden. That is to say not banned. So it is the reverse of what is being proposed with respect to what you are calling reproductive cloning.

It looks to me as though that requires, in addition to whatever scientific information we have about the possible cure for diseases and development of therapies, it requires the ethical premise, the extra scientific premise that the destruction of the blastocyst is not sufficiently of more weight to justify a conclusion other than the conclusion that the nuclear transplantation procedure should be permitted.

DR. WEISSMAN: Not at all.

PROF. GEORGE: Okay. Can you explain that?

DR. WEISSMAN: What we said, and if we read the whole paragraph, it says, "The scientific and medical considerations that justify a ban on human reproductive cloning at this time are not applicable to nuclear transplantation to produce stem cells." That is the first point.

So we are reporting to you that what we saw as a problem with human reproductive cloning from a scientific and medical and human participation point of view does not apply to this method of producing pluripotent human stem cells. Then we mention, of course, because of the considerable potential, which I have now gone into much more depth than you probably wanted about the diseases, we said and recommended that "biomedical research using nuclear transplantation produced stem cells be permitted." And the very next sentence we say, "A broad national dialogue on the societal, religious and ethical issues is encouraged on this matter."

We ceded the responsibility for the ethical and the moral determination of that research not to us but to broader bodies and we said it not just in that wording of the language but everywhere in the report, and you and I could go through it. Maybe 10 or 15 times, you know, we said it over and over and over again.

PROF. GEORGE: It looks to me like you have got two recommendations here and they are in successive sentences. The first is a recommendation "that biomedical research using nuclear transplantation to produce stem cells be permitted." That is a recommendation. I realize you do not have authority, nor do we, to make that a legislative matter. It is a recommendation.

And then there is a second recommendation in the immediately following sentence, and that is "A broad national dialogue on societal, religious and ethical issues be encouraged on the matter."

CHAIRMAN KASS: Counselor, may I help you out?

PROF. GEORGE: Please.

CHAIRMAN KASS: I was over that paragraph several times because it does look at first glance to be something like -- and one could rewrite it to take the ambiguity out. I think what that really says is that we find no grounds here as we find with reproductive cloning to recommend a ban because the safety considerations obviously do not apply for obvious reasons. In addition, we think there are perfectly good reasons to do this.

Nevertheless, there are other ethical considerations which we would recommend the broader society take up. "Should be permitted" seems to be a strong moral conclusion. I think it should say "should not be banned on these grounds." I think that is what --

DR. WEISSMAN: We are not going to go back and --

CHAIRMAN KASS: No, but I think that is --

(Simultaneous discussion.)

DR. WEISSMAN: What I would like you to see is the rest of the report where we stress where our responsibility and recommendations end and society's responsibilities begin.

PROF. GEORGE: Oh, yes. Well, I am not asking you to redraft it and that is a very helpful explanation of Dr. Kass'. I mean, is Dr. Kass right that what you are saying here -- I mean, the proper translation of that is we see no reason on scientific and medical grounds not to permit nuclear transplantation? Is that what it means?

CHAIRMAN KASS: And they see positive reasons to do it.

PROF. GEORGE: And there are positive reasons for it.

CHAIRMAN KASS: There are positive reasons compatible with the moral character of medical research.

PROF. GEORGE: I mean, if that is what it means, it seems to me, fine.

DR. WEISSMAN: It is my personal opinion that that is a reasonable interpretation of what we say but I cannot --

PROF. GEORGE: Speak for the group.

DR. WEISSMAN: -- speak for the group.

PROF. GEORGE: Okay.

DR. WEISSMAN: Because I would have to go get a vote.

CHAIRMAN KASS: Thank you.

PROF. GEORGE: Thank you.

CHAIRMAN KASS: Look, we are at the time where we said we would break. I, with your indulgence, since there are a number of people in the queue, if we could take -- steal say 15 minutes from an hour-and-a-half lunch, I think it would be fruitful and I will try to keep -- I think this back and forth is sometimes useful but we now have Michael Sandel, Michael Gazzaniga, Stephen, Bill. Which Bill? Was it Bill Hurlbut? Alfonso and Charles. And if you can make it, all six of you, within 15 minutes, let's try.

Michael Sandel, I guess.

PROF. SANDEL: I would like to restate a worry that was voiced by Charles and Leon and maybe others but to reformulate it and to get your own view of it not speaking for the Academy. One way of reformulating the worry, and I do not want this to be on their heads so it is my formulation, it is one thing to create, to clone or to create a blastocyst of five to seven days and to extract stem cells from it to do potentially wonderfully things of the kinds that you have described.

But if we do not ban that potentially very promising thing then there is the real danger that the scientists now or in the future will be tempted to go further beyond the five to seven day blastocyst and to develop it, to grow it to some further stage of development, not because they are crazy rogue scientists who want to create a baby but because there will be other wonderful medical research possibilities that will come later, whether that means implanting it in a cow or in a pig or developing something in a laboratory where they do not have to implant it.

And if it really is tempting medically, not just a crazy rogue thing for some weak purpose, where do we draw the line?

Your answer to that before was, "Well, this was not part of the charge of the Academy." And your second response was, "Well, the science -- there is no evidence that this can be done."

And so the way I want to reformulate -- well, so I want to put that question to you again. Where do we draw the line if there are very tempting, attractive possibilities of developing going way beyond this five to seven day, 64-200 cell stage, to have a much more fully advanced thing that begins to look more and more like a fetus? What about that? Can you just respond to that?

DR. WEISSMAN: So long as you say in this conjecture that it could all be done in a test tube, that it does not require a human subject because I am very clear about the use of human subjects.

PROF. SANDEL: Okay. Suppose there is a way of doing it. They are worried about ways of doing it without a human -- without implanting it into a woman.

DR. WEISSMAN: Right, so it --

DR. KRAUTHAMMER: Without a human subject because otherwise it is easier to reject.

DR. WEISSMAN: Right.

PROF. SANDEL: So what do you say --

DR. WEISSMAN: What I am trying to say is, just so that we are all clear, that -- so we do not go into pure science fiction -- that to carry it beyond that stage at an institution, say like mine, I want to do that experiment. Let's say I am going to try to find a way to carry it in vitro or put it into a mouse uterus.

PROF. SANDEL: Right.

DR. WEISSMAN: Okay. So with a purpose of going on.

PROF. SANDEL: Right.

DR. WEISSMAN: That is clearly covered by my institution by its institutional review board and the use of any materials from humans and so if I were to do it personally I would have to get approval from a group that includes ethicists, lawyers, da, da, da, da. And so individually if I try to go beyond the bounds of the experiment as a responsible scientist who wants to keep his job in my institution I have to go before a review board and I would be kicked off the faculty if I tried to do that on my own.

So let me just go forward. So now that now relegates it to those who are not in institutions that have a requirement of an institutional review board and, as I said before, although we did not consider that, and this -- and our findings do not project to that -- that I think it probably is an important question for you to get medical facts on and scientific facts on, and we did not do that for you.

PROF. SANDEL: Could I put the question from another angle, which is suppose -- never mind your review board and what standards they might or might not use or should use -- it would bother you -- and now here I just mean you and not the Academy group -- it would bother you as a scientist if there were a federal ban on nuclear transplantation to produce stem cells because it would foreclose important scientific and medical research.

DR. WEISSMAN: Right.

PROF. SANDEL: Would it bother you as a scientist if there were a law that permitted nuclear transplantation to produce stem cells provided that there were no implantation and that were also a time limit, say 14 days, on how long the thing could live? Would that bother you?

DR. WEISSMAN: It would not bother me at all with the implantation ban. Not at all.

PROF. SANDEL: What about the 14 day limit?

DR. WEISSMAN: The 14 days, I am just worried for you and for me that that -- putting a time limit on it rather than a stage limit on it is not precise enough to do what you or I may want to do.

PROF. SANDEL: Put a stage limit on it then.

DR. WEISSMAN: Well --

PROF. SANDEL: Suppose this case --

DR. WEISSMAN: -- I think that it would be reasonable for you to try to go into the question of what kinds of regulatory bodies could be set to look at these questions as a requirement for that kind of research just as the Recombinant DNA Committee, as a requirement, regulated commercial, public, private use of recombinant DNA and not to anticipate on a case per case basis ahead of time what would be permissible or not but to give clear enough guidelines and include people on that paper, ethicists, lawyers, scientists, so that on a case by case basis we can understand where it should or should not go forward given the context of the science and the medicine and the society at that time.

Is that sufficient?

PROF. SANDEL: Yes. I want to let others. Go ahead.

CHAIRMAN KASS: Michael Gazzaniga, please.

DR. GAZZANIGA: Pass.

CHAIRMAN KASS: Stephen Carter and then Bill.

PROF. CARTER: I will be very brief. We have given you, Dr. Weissman, kind of a hard time and you have been very gracious in -- and very patient with us. We have talked a lot about areas of potential or implied disagreement. Now I want to ask you briefly about something, which I suspect there is widespread agreement around the table, and with -- and which you also agree, and that has to do with the ban on what you have called "human reproductive cloning."

It will come as no surprise to members of the Council that whatever my view of a particular matter, I am an extreme skeptic of regulation. Extreme. Your report suggests that there ought to be a legal ban nationwide, and I suppose this would not preclude the possibility of negotiating international treaties that would include a ban and an international ban with very substantial penalties. You are talking about putting scientists in jail basically who attempt various procedures of this kind.

Are you worried at all that a ban like that enforced and developed with the consent, in effect with the enthusiasm of the responsible scientific community, could open a kind of Pandora's box? That is what lawyers like myself refer to as slippery slope arguments that, well, the next thing comes along; well, we banned reproductive cloning, what is the big deal if we ban this too; we will have to lock up scientists for that, why not lock them up for this too. I mean, I realize that is not within what the committee would have thought about but for you as a scientist isn't this worrisome, this very proposal you have made that there is a slippery slope character to it?

DR. WEISSMAN: I will try to answer that. Of course, this is personal. This has nothing to do with the committee.

PROF. CARTER: Right.

DR. WEISSMAN: Right, Maxine, Debbie?

PROF. CARTER: Just from your heart.

DR. WEISSMAN: Okay. And you will help me on it in a second. So I will say it and then if I could ask for Maxine to respond also.

I am very worried, and I have been lobbied by a number of scientists that this is a dangerous thing to do, that is to have a legally enforceable ban, and I always go back to the precedent of what is legal for human research based on the Nuremberg Code and what follows because that, I understand, has been well thought out. It has been discussed. Virtually all the cases that we could have considered were in that.

Now, if other groups in society, in Congress, in the House, the Senate wish to now extend the argument and use that as a precedent, I hope that they would go through the same sort of deliberative process to understand what is gained and what is lost. I do not usually buy slippery slope arguments because you have got to see it happen for a scientist before you believe that was a slippery slope rather than an assent or impossible barrier. You know what I am saying?

PROF. CARTER: Sure.

DR. WEISSMAN: So personally I am worried about it but I have some trust that deliberative case by case analyses hopefully will not make this a slippery slope where there is a huge wholesale ban on science. I think that a ban on nuclear transplantation was proposed and passed in the House because of the conjunction of the terms "cloning and human reproductive cloning" without such scientific knowledge and certainly without deliberation.

Now, Maxine, could you please respond?

DR. SINGER: You will find it on page 63.

DR. WEISSMAN: Oh, good. See, she knows this better than I. So you could read it or I could read it to you.

DR. SINGER: You read it.

DR. WEISSMAN: "There is concern that legislation or regulation that would ban reproductive human cloning would set a troubling precedent with respect to the restriction of innovative experimental research and medical procedures. Modern scientific research proceeds rapidly and its findings are unpredictable and often surprising. It is probable that at least every five years there will be significant new information regarding the issues of the safety and applicability of human cloning to medical practice. The above concern can be ameliorated by including in any legislation or regulation a requirement for an updated evaluation of the scientific, medical and societal issues within five years. Such a requirement for periodic reviews would allow for extensive public debate regarding reproductive human cloning and the consideration of modifications to the legislation."

PROF. CARTER: Let me say that I read that finding and, in fact, that is what generated the question.

DR. WEISSMAN: Okay.

PROF. CARTER: Because surely the five year review does not answer the fundamental problem. I mean, because, after all, if one is worried about the slippery slope, and I am glad you are not too worried about it but I am worried about it a little bit, if one is worried about slippery slope I assume that the next problem, whatever it may be, to come along that one -- that some say nonscientists -- it could be a scientist -- wants to regulate, we just say, "Well, we will also include a five year sunset provision or a five year review provision. That will take care of any concern about..." because clearly it would not because clearly if there is something that where you as a scientist felt unjustifiably hemmed in or I, as a skeptic of regulation, worried the government was simply doing too much, that the fact that we say we will not do it for five years would not change either your sense of being hemmed in or my sense of the government doing too much.

DR. WEISSMAN: "Within five years" was the --

PROF. CARTER: Within five years. I understand that.

DR. WEISSMAN: Sure. A legislature could do that but if they did it in the way outlined in Finding 8 there would be a process by which the information could be gathered and delivered to the legislative body. So even though they could do it and can do it and have done it, you know, what we are insisting here is that they ought to do it with full knowledge of what is going on.

PROF. CARTER: Thank you.

CHAIRMAN KASS: I am going to urge people to be more succinct.

Bill, Alfonso, Charles, and then we will break.

DR. HURLBUT: Irv, drawing on the sense of the previous question, we spoke of the rapid pace of research and the undesirability of restriction so I am asking this question in the spirit of trying to keep open as much possibility in the scientific arena as we can morally do. Our mandate as a Council is to consider not just the immediate but what could come from immediate decisions and what seems reasonable to project in the way of scientific process.

So I want to return to that unpleasant subject of use of this entity beyond the blastocyst stage and I want to try and get at the heart of the question that is really beneath the moral issue here, and that is the status of developing life.

You, yourself, have said that you do not favor an implantation of this developing organism.

DR. WEISSMAN: With a restriction.

DR. HURLBUT: You can live with a restriction, okay, and I took it from that that you did not like the idea of implantation.

Others might say, "Get your laws off my body. I have a good reason to do this." And one might make a good scientific argument that you could get cells, as I mentioned earlier, limb primordia, organ primordia, from the harvesting of a fetus at a later stage that would be, indeed, useful.

Now I am not trying to suggest scare scenarios. I am trying to find a moral way that we can keep open these wonderful possibilities. When I said that I had seen a human hand in the bottom of a test tube, when I saw that I had two conflicting thoughts. One was that that was going to be a human hand had it not ended up as an abortion and then grown in a SCID mouse but my other thought was fantastic. Maybe some day we can generate hands for people with amputations.

My point here is can you help us, and this is my question, can you help us as a Council with any scientific information or perspective you have to gain some grip on this question of the moral status of developing life?

I had a conversation with Ian Wilmont, a long one, which he said, "Look, we do not know when moral status emerges but it is like the difference between midnight and noon. Somewhere in that process there is dawn." But that has a metaphor behind it and that is that there is an accrued, accumulated or maybe even earned moral status in the process.

Is there anything you know scientifically that can help us think clearly about where we should assign moral status to this developing life? And here I am thinking not just of the improbability of it successfully going forward, which is a quantity argument, not just the size, and this is all we are talking about roughly, eight cells on the top of a sharp needle so it is very small, but something like individuation, twinning. Can you give us some scientific thoughts about what the moral -- what bears on the moral status of this entity?

DR. WEISSMAN: Let me answer that by saying a couple of things. That certainly, I know, for years is an issue that vexes you and it vexes each of us in our own individual way. We, as scientists, bring no more knowledge than anybody else about that particular moral question. I could, and Michael could do much better than me, describe to you when the possibility of thought -- not just the possibility but the actual function of thought, mind consciousness, those human characteristics come about, but it is not going to be a moral argument and it should not impinge on the moral argument that you are trying to deal with.

It is a very vexing, and it is a personal issue. Scientists have no better and no worse prior knowledge from science about where to go with that argument but you must recognize that there will not come out of even this body a common agreement about when that moral issue comes about because we each bring our backgrounds to it.

I doubt, you know, if I would give you the precise stage or days after implantation that one would say when thought begins that you would have that or that you would have a common agreement in this group as to when it has "the moral dignity that you are trying to apply to it." I just cannot participate in this in any way that is more informative than you can or anybody else around this table. So I just -- you know, that is an argument and we cannot settle that argument in this way.

DR. HURLBUT: A tiny subquestion?

CHAIRMAN KASS: Very quickly.

DR. HURLBUT: Do you think that this issue of when twinning can occur early, the early inchoate qualities that have been assigned to the embryo, should bear on our thinking on this?

DR. WEISSMAN: You would have to explain more to me about where you are going with that because I do not see it as an issue that is relevant to what I have presented to you.

DR. HURLBUT: The argument being if it does not have individual personhood should we consider its moral status different than after -- than at a date in which twinning can no longer occur. Do you think there is any reasonable scientific basis for such an argument?

DR. WEISSMAN: All I think is that the twins I know are two different individuals every time.

CHAIRMAN KASS: Charles?

DR. KRAUTHAMMER: I think we are all hungry and I will pass.

(Laughter.)

CHAIRMAN KASS: First of all, Irv, thank you very, very much for making a special trip just to be with us on this occasion. Thank you for -- first of all, thank you, and I think I speak for everybody, for the work of your Academy committee in preparing this report. There are things that you have left for us to do but you have done a huge amount of work that we now do not have to do in documenting the evidence on the safety of this research and, also, for exploring and, to some extent, raising some questions that are not generally raised in the media about so-called therapeutic cloning and the way in which it has been touted, and also for showing us how things that are generally not talked about, namely the kind of research that you have elucidated here, is, in fact, maybe even more important to the scientist's interest in proceeding with the nuclear transfer to develop stem cells.

We may have occasion to consult with you again. If you would be good enough to -- there are some questions that were submitted to you in writing, many of them we have dealt with, if we might take the liberty of sending some further questions on to you as they occur, either now or down the road, we hope you and your colleagues might be obliging and help --

DR. WEISSMAN: I would certainly be happy to and I could provide you written responses, if you wish, for the questions already because I already wrote them.

CHAIRMAN KASS: Right.

(Laughter.)

CHAIRMAN KASS: Very good. One further thing, I mean, there were suggestions in the early discussion that the conversation about terminology would be vastly improved if we heard from Irv Weissman first. We have now heard and I think it would be incumbent upon us to spend at least ten minutes or so at the beginning of the afternoon session to revisit the terminological question to see whether that is, in fact, the case.

We are adjourned until 1:30. The Council members will have lunch in the room, whose name of which I cannot remember but it is where the continental breakfast was served.

(Whereupon, at 12:20 p.m., a luncheon recess was taken.)


* * * * *

AFTERNOON SESSION

CHAIRMAN KASS: Perhaps we could try to get started. Sorry about the late beginning and the delays in the provision of lunch. I hope everyone is a little bit refreshed.

I did say before lunch that we would revisit the terminological question. I am going to try to keep a lid on this because I am sure we will not get it done today but it does seem to me a reprise on that topic after having the last discussion might be helpful as we think about what we should call what and how to describe and justify what we do. Both of those things, I think, are important.

I mean, I think some explicit discussion of the terminology, I think, would be a really useful contribution but then we do have to make some decisions at the end about the stipulations that we make and I wonder if anyone wants to start.

Frank, please?

PROF. FUKUYAMA: Well, just on the basis of what Dr. Weissman said, it seems to me that one term that is in common use that should not be used is "therapeutic cloning" because he clearly said that therapeutic cloning is a subset of what is actually intended and that in that respect research cloning of the conventionally words is much more accurate. So with or without quotation marks I think we should not use that word anymore.

His attempt to redefine -- let's now call it research cloning as, you know, somatic cell nuclear transfer, I think is just by his own example, you know, unjustified because, you know, his example of the rifle -- you use a rifle for different intentions but we do not give a different name to a rifle that is being used to kill somebody and a rifle that is being used for hunting. I mean, they are both, you know, equally rifles and it seems to me that to try to distinguish, you know, research cloning and call it something else is also, you know, by his own presentation not justified.

CHAIRMAN KASS: Michael Sandel?

PROF. SANDEL: Well, what I have to say is consistent with what Francis has just said. I think we should reject the term "therapeutic cloning" because it is misleading for reasons that people around the table have raised and I do not think it is sufficient just to use the term with or without quotation marks and then put a stipulation because the stipulation will get lost to the public discourse.

So, if we want to dislodge that term, we have to have another term that is not too bound up with technical jargon that would perform the kind of role that it has played by default in public discourse. So, I think, that we should reject therapeutic cloning. I think we should also not substitute "nuclear transplantation" because it is overly technical and the Working Paper brings out the difficulty of doing that and it will not enter into the public discourse anyhow because it is too highly technical.

I do think there is another term that could easily enter into the public discourse that would be more accurate than therapeutic cloning, which would be to distinguish "reproductive cloning" on the one hand from "stem cell cloning" on the other.

Now, there is one objection that I want to respond to in advance to the use of stem cell cloning, and here I want to go back to one assumption -- one premise of the Working Paper that I would like to question.

First, I think the gist of the Working Paper on terminology is right and important that we should name things not according to their technical terms but in ways that would capture their human significance or the human import. I think that emphasis is right and persuasive.

I think that part of the Working Paper's argument is intentioned with another view that appears in the Working Paper, which says, "We should distinguish the what of the act from the purpose for which it is done." Separate purpose from deed. I think those two aims are intention because if we want terms that address the human import, that go beyond the merely technical forms of description, it is very often impossible entirely to separate the purpose, and here I would give an example from an area that has nothing to do with the controversies we deal with.

We distinguish commonly between amateur athletics and professional athletics. The games in many cases are the same but we distinguish between the two because the practices are different and they are different descriptively in ways that have to do with their point or purpose. Amateur athletics are for the love it whereas professional athletics are for the compensation of money.

So there is -- and the consequence of the distinction, which draws to some extent on purpose, has importance for the kind of regulations that govern those activities. And, I think, in this case, too, it would be a mistake if we want to move beyond the merely technical, which I think we are right to want to do, then we should not so try to sanitize the definition as to completely rule out any reference at all to the purpose or the point because that just -- then we will not achieve the first aim. The only way to be sufficiently sanitary and pure would be to lapse back into the purely technical language.

Well, that is all by way of addressing this discussion we have had many times about whether we can all together detach purpose from the naming of the activity. So to go back to the suggestion, it seems to me that reproductive cloning versus stem cell cloning is accurate to the kind of practices that we are describing and in a way that is more or less compatible with common sense and ordinary usage, and that it does not really prejudge the moral issues. The moral issues we could discuss. At least it would be an improvement on therapeutic which is misleading for all kinds of reasons.

CHAIRMAN KASS: Response, Charles? I have Charles and Janet.

DR. KRAUTHAMMER: I just have one problem with that, Michael, and that is if in the future the research cloning is extended, as we were discussing, beyond stem cells, it would require a third name. I wonder if it would not be better to find a more expansive term today that would encompass research that might go beyond stem cells, which is why I am sort of partial to Frank's suggestion of research. I had offered a more wooden and perhaps more acceptable alternative of nonreproductive. Simply by being a negative it says almost nothing. But I am just concerned if we restrict it to stem cells we might be conceding something that may not be true in the future.

CHAIRMAN KASS: Jim?

DR. WILSON: I support Michael's suggestion or at least I thought I did until Charles made his introduction. Reproductive versus nonreproductive cloning, it seems to me, captures the essence of it and if there is something beyond stem cells that we may eventually find, it avoids whatever problem may be associated with Michael's proposal but for the time being, if Charles' intervention does not carry the meeting, I would like to second Michael's suggestion.

CHAIRMAN KASS: To embrace Charles' qualification, would there be something wrong with saying "cloning for medical research" so it does not somehow tie it simply to -- see, stem cell cloning has a certain kind of ambiguity because it is not clear whether what you are doing is cloning the stem cells, that kind of confusion, whereas cloning for producing children and cloning for medical research has the parallelism where the goal or the purpose is somehow there and --

DR. KRAUTHAMMER: And you could even in theory even apart from the exception of developing beyond the blastocyst stage and, therefore, having a different kind of cloning, you could, in theory, develop only up to the blastocyst stage and not particularly be interested in stem cells. You might be interested in another aspect of embryology.

CHAIRMAN KASS: Right.

DR. KRAUTHAMMER: And have produced a clone for that reason so that, again, I think it is too restrictive and I would endorse either "research or nonreproductive."

CHAIRMAN KASS: There were a bunch of hands now. Rebecca, Stephen, Robby.

PROF. DRESSER: I would suggest another possibility is cloning for biomedical research, which gets away from this cloning for pure curiosity that research alone might imply.

CHAIRMAN KASS: We had medical but biomedical --

PROF. DRESSER: Right, medical.

CHAIRMAN KASS: -- biomedical is --

PROF. DRESSER: So, I guess, I do not know. Is all -- would all the scientific interest be medical research or would some be more accurately classified as more basic biology, and I do not know where you draw the line there but I will just throw that out.

CHAIRMAN KASS: Does someone want to answer? Some of the scientists speak to Rebecca's last question. Would there be anything wrong, anything left out or anything improperly hinted by calling this "cloning for biomedical research"?

Janet?

DR. ROWLEY: Well, actually I sat next to Rebecca for lunch and she brought this up and I thought that that was an appropriate term.

CHAIRMAN KASS: Good.

DR. MCHUGH: It would encompass the idea that after all some of this cloning is being done in animals and if we want a broad term to include animal research -- unless we are going to begin all of this by saying "human reproductive cloning and human biomedical cloning."

DR. FOSTER: I think that the scientific -- I think I disagree a little bit with Janet. I think the scientific community, many of them who are pure scientists, even though they work on things that are applicable subsequent to medicine, would object to the idea of biomedical science. They may be working on a slime mold or something else, you know, so that I would -- I do not know. I thought it would -- I mean, I know why you want to put medical in it but I just want to make the point that I think that a number -- I have heard this objection not in terms of this but just in introductions people do not want to be described as doing biomedical research.

CHAIRMAN KASS: They would rather say "medical research" or the other.

DR. FOSTER: Say research.

CHAIRMAN KASS: Just like say research.

DR. FOSTER: Yes. Anyway, any word you use is probably going to be a difficult thing. I do not think that is a major point. If everybody likes biomedical that is fine with me.

CHAIRMAN KASS: Stephen, and then Alfonso.

PROF. CARTER: I would still very strongly prefer that we choose terms less freighted in the neutral sense of the e-mail I circulated earlier in order to avoid the objection that Robby George made last time and that others may make at other times who may feel that every act of cloning is an act of reproductive. However, if we are not going to be concerned about that objection and we are going to go in this direction, I think I certainly could sign on to the kind of phrases that are being used around the table as long as the definition itself drew distinctions only concerning the intent of the actor and no distinction of any other kind. I mean, the definition is as important as the word itself.

If, on the other hand, we are talking about something other than the intent of the actor then the words have much greater concern about but if the only distinction is the intent of the actor then I could probably go along with this.

CHAIRMAN KASS: We could get around, by the way, the reproductive part if one talked about for producing children and really spoke the language of the street.

I think I had Alfonso, Gil, Bill May, someone's hand, Robby. Okay.

DR. GÓMEZ-LOBO: Actually I am happy the direction things are taking because, as I said this morning, I think we have to name three different things. Cloning on the one hand and then what is going to be done with a clone.

Actually, I really regret that it was too late this morning to make a last remark but from the figures or the charts that we were presented, I just cannot avoid the conclusion that there is the same cloning -- I think Dr. Weissman admitted that -- in both cases. So we need cloning and then move on and say, "Well, for reproductive purposes for biomedical research." I think it would be a mistake -- it is a mistake, I think, to talk about different types of cloning. There is only one type of cloning.

CHAIRMAN KASS: Gil, Bill May, Robby, Charles and Michael, and then I am going -- unless somebody has an epiphany -- say that -- or unless we are moving now -- unless there are no bombshells here, it looks like we are moving in a direction where the staff can do some work and have it circulated.

Gil, are you going to keep us on the track or go somewhere else?

PROF. MEILAENDER: Well, I could probably -- I am a little uncomfortable with definitions that incorporate purpose or not definitions but terms that already incorporate. In a certain sense I prefer just research for the purpose of -- but I could live with that. It seems to me that I want to reemphasize the point that Stephen Carter just made. It is apparent to me now, whereas when I came this morning to the meeting I might have thought that the issue was just can we find a set of terms that we will agree on, the really crucial question now is what is the content that we pour into these terms and whatever the terms are, and I can live with several possibilities, it is crucial that, you know, if you think of the kind of definitions the Working Paper offered, that whatever is said about proximate purposes or ultimate purposes it is crucial that these two terms be described in a way that makes clear that the act is the same. And, you know, if we can do that then there may be various terminological choices one can live with.

CHAIRMAN KASS: Bill?

PROF. MAY:: I just do not think that is right, Gil, because what you are doing is disaggregating and isolating and that is what I found wrong in the Working Paper #5. It really proposed seeking to disaggregate and isolate the naked act from the intention and there has been a lot of confusion over this issue but my one worry about cloning for medical research that does not exclude reproductive cloning in one sense. You need the other pair in order for it to be clear. That is one awkwardness of the term and one advantage to Charles' suggestion of "nonreproductive cloning research." It made it clear that it built into the definition there this purpose that it excludes the other purpose and that is not clear from the phrase "cloning for medical research" alone. That is my awkwardness with that.

CHAIRMAN KASS: Thank you. Robby?

PROF. GEORGE: Well, if I understand what is really in dispute, both in the group and in the polity, it is this: Some people think that there should be a ban on cloning, all cloning. Other people believe there should be a ban on the implantation of human clones. The ban is really a ban on implantation, not on cloning. So if we feel that we have to make reference to cloning with respect to both possible bans in order to deliberate about them, might it make sense to distinguish cloning for the purpose of research or biomedical research or medical research on the one hand and cloning for implantation on the other since I take it on anybody's account what is going to be banned or not banned in the latter case is implantation.

We might have a debate about what constitutes reproduction, whether to use the definition of cloning from the National Academies of Sciences Report, whether we take cloning as bringing into being an exact genetic replica of a DNA molecule, cell tissue, organ or entire plant or animal, right, if we take that as a definition of what cloning is then calling something where we intend in the end to raise a child reproductive cloning is going to create the problem of whether reproduction has already taken place when we make the exact copy but if implantation is the real issue in debate and whether people should be permitted to implant the human clones then that should be what the reference is, I think.

CHAIRMAN KASS: Well, the intent -- I mean, if we -- and Bill May I have a more than a little sympathy with. Bill really is joining Michael Sandel's comment about to be fair to the human character of the human act one does not at least sometimes have to look at -- not just the literal intent of the act but the purpose that it -- that motive that it serves. Though, sometimes acts do have meanings separate from the intent -- from the purposes that people use them for.

PROF. SANDEL: The difference, by the way, between purpose and intent, how would you say purpose, not intent?

CHAIRMAN KASS: Yes.

PROF. GEORGE: But isn't it true that people -- I think --

CHAIRMAN KASS: I do not think --

PROF. GEORGE: -- the proposed ban on "reproductive cloning" would ban implantation even if the person doing the implanting intended not to raise a child but to harvest organs from the child or from the fetus that grows out of as a result of the implantation? What is banned would be everything -- would be implantation as such. Somebody could implant with a view to harvesting organs from the more fully developed human being. That would be banned by the proposed ban on human reproductive cloning.

CHAIRMAN KASS: That is interesting, yes.

Michael, please?

DR. GAZZANIGA: Just to weigh in, I go back to Charles'. I like his the best, reproductive versus nonreproductive, and for the simple reason that by calling it cloning for biomedical research for the reasons that I want to see the words "creation" taken out of there and go to "synthesis" and I want to see some of these other words -- biomedical, how can you be against biomedical whatever? It is loaded. It is loaded in favor. So if we are trying to make everything neutral and accurate and dispassionate, I think reproductive and nonreproductive captures the two domains that we are trying to grope with here.

CHAIRMAN KASS: Let me respond if I might. I mean, I -- nonreproductive is empty. That is to say it is precisely -- its virtue and its weakness is that it -- whereas, one should -- human intentions usually are in the pursuit of some good and, therefore, to say cloning for the sake of biomedical research or medical research is a way of describing how Irv Weissman understands that act. He does not really understand there are separate acts in which there is a product and then you do something to that product for your stem cells. He regards that activity as continuous. Whether we agree with him or not is besides the point. And it seems to me the problem is then the ambiguity about the word "reproductive" where some of us think any kind of capacitation of an egg to start developing is the reproductive act and not just the implantation.

So, if one could speak crudely, one would say cloning for baby making and cloning for medical research. I do not think that a dignified body like this can go around talking about baby making and then there is Robby's wrinkle whereas that would describe the human purposes. The legal language actually does not -- deals with the intent to produce a child by proscribing a particular act, namely the transfer of this to a woman's uterus.

So, I am not exactly sure how this shakes down but I would prefer not to go reproductive or not reproductive but to state the positive aspiration of the purpose as part of the intent because I think that truly reflects why people want to do it and I think people would understand that biomedical research is a good but it is not in all cases a trumping good and, therefore, to say this is the intent does not mean that the conversation stops there but it does describe what people are trying to do with it.

DR. GAZZANIGA: I am all for biomedical.

CHAIRMAN KASS: I understand.

DR. GAZZANIGA: I was just trying to be fair.

(Laughter.)

CHAIRMAN KASS: Charles?

DR. KRAUTHAMMER: But perhaps we could agree on research. If it is fair to you, I think it would fair to everyone. I proposed the "nonreproductive" as a lower common denominator but if we can progress beyond that to research that might be our solution.

I would just propose a minor editorial of the points. I do write headlines for a living. It would be a lot easier to make our impact on the language with a shorter construction. "For the purposes of" will not survive the headline writers. The reasons "Axis of Evil" will live forever is that all the words are four letters or less, and that is how it works.

So I would suggest a very simple two terms. "Reproductive cloning and research cloning." And if that would satisfy everyone, I think it would actually stick.

CHAIRMAN KASS: It is not going to. I mean, because I -- for reasons that Stephen has alluded to and Robby is nodding.

Let's work on it. I mean, that might be the way we go and make it perfectly clear and I think Robby even last time allowed us to continue the discussion having registered his demur.

PROF. GEORGE: And we may be half way there, Charles. I mean, I am not hearing objections to cloning for research or research cloning. Are there?

DR. ROWLEY: I would object to that because I think that an aspect of this is really the hope that it will have medical therapeutic consequences. Well, I actually like Rebecca's term of "biomedical" because I think it is broader and you are not going to get anybody arguing with you, Dan, over slime mold and what rights the slime mold has.

DR. FOSTER: I knew that was a terrible example when I used it.

(Laughter.)

DR. FOSTER: I knew that I should not have used that one because I understand about slime molds but I was just trying to say basic science. I yield, Janet. I would never oppose you about anything.

DR. ROWLEY: Well, no, but -- so, I --

CHAIRMAN KASS: Alfonso and Gil and, I think -- oh, I am sorry, Michael, and then we are going to -- I am going to just call a halt to this and we will try to --

DR. GÓMEZ-LOBO: How about simply "cloning for reproduction, cloning for biomedical research"?

CHAIRMAN KASS: They do not like prepositions, these journalists. We are not necessarily just writing for them. Let's keep that in mind, Charles.

DR. KRAUTHAMMER: We could actually be coining usage which if we were to agree on usage that was sort of nonprejudicial, reasonably accurate, that would be a contribution to the debate.

CHAIRMAN KASS: Indeed.

DR. KRAUTHAMMER: So if we can do it -- and I suspect if that is the name of our report, it will stick because that report will be quoted a lot.

PROF. GEORGE: Maybe this is where you want to go, Alfonso, but here I think is the problem and maybe it is not a problem if you would want to go there: If someone says, "Well, look, we want to be able to for our research, in connection with our research, we want to be able to implant the cloned human being but we guarantee you, I mean we have got a deal with the mother host, we guarantee you that we will extract and destroy that clone before birth." Is that reproductive cloning or not? It seems to me that what the proposed legislation is about is banning implantation, that that is where Dr. Weissman's line in the sand is.

PROF. FUKUYAMA: The goal is not to ban implantation. The goal is to ban the production of a baby. The implantation is only the method used to achieve the goal.

PROF. GEORGE: So what would the answer be? Would the ban permit -- if you banned reproductive cloning, what we are calling reproductive cloning, would someone be in violation of the ban if they implanted, permitted the cloned human being to develop into the fetal stage, and then extracted it?

CHAIRMAN KASS: We separate these things. It seems to me for the discussion of what it is we are talking about for the discussion of the ethical analysis, we take it up without making the thing focus on implantation. We talk about the purpose and then we have to face the fact that when one is thinking about legislative alternatives you have to give operational meaning to what the prescribed act is since reproduction is unclear, whereas implantation is a deed which can be then spoken about. I think we could separate our consideration of that in the two parts of our document.

DR. KRAUTHAMMER: And if you had an artificial uterus, it would be another counter example. So you could multiply them indefinitely. I think Leon is right. It is the purpose that we ought to focus on. It is clear and it is pretty straight forward.

CHAIRMAN KASS: I think I had Gil and Michael Sandel, and that is the end on this. Gil?

PROF. MEILAENDER: Just very briefly, I think that if we find -- if we choose language that does not distinguish what one does from what one hopes to accomplish in the doing that we will not speak clearly.

CHAIRMAN KASS: I think that is handle-able by the careful description of the deed of cloning so that while the purposes are present, the analysis will also do what Stephen Carter wants to have done. I think -- I am much more hopeful at this point than I was when I -- when Michael opened up this morning. I think we can do this. I think we can do it and we will try.

Michael -- by the way, the assignment is still there. Draftsmen, wordsmiths, analysts, if the word "embryo" is not to appear, the word "being" is even weightier and "entity" will not do because it is really just a surreptitious word for "being", we have got to put something in that place and some people do not like "organism". We will work on it.

Michael, and then we will go forward.

PROF. SANDEL: I have no objection to cloning for medical research or biomedical research, though that is a big longer. But I just wanted to respond to Charles' question whether the briefer stem cell cloning is too restrictive. If insofar as you consider it desirable to restrict the practice to what was being described by Irv on the blastocyst, to the extent you are concerned about not having it spill beyond that into the scenarios that you and others have raised, it may be an advantage, you should want the term "stem cell cloning" if you are using that term in the context of describing what in narrowly circumscribed ways may be permissible because then it will be clearer that the nightmare scenarios of the farming of the organs of advanced fetuses and so on do not fall under that permission.

So that it is restrictive may be in social, moral and political terms discourse an advantage rather than a disadvantage. Whereas, if you have an expansive term that could include all of those -- the horrors down the road that you want to delimit then I think that I would be a drawback from the point of view of wanting to narrow it.

DR. KRAUTHAMMER: That is a good point but it is a subset of what we are almost agreed here to call research cloning. So it could be a useful phrase to describe exactly what Irv wants to do and was showing us on the board but it does not describe the full range of what we will probably be pronouncing on or recommending about.

So I am saying within a report on research cloning we could speak specifically of stem cell cloning as a subset and perhaps offer it, if you like, as a permissible subset to distinguish it from the other so it could be useful in that sense.


SESSION 3: HUMAN CLONING 6: ETHICAL ISSUES IN "REPRODUCTIVE" CLONING

Working Paper #6: The Ethics of "Reproductive" Cloning:
Child, Family, And Society

CHAIRMAN KASS: Thank you very much. This was, if I may say, a good thing to do to revisit this in the light of that discussion. I mean, the science was helpful. At the same time it was not determinative so that we have been, I think, helped along.

The rest of the afternoon, unless we, contrary to possibility, finish in a hurry with this issue is devoted to the ethics of -- now I cannot even finish my sentence -- of cloning for baby making, and the relevant working papers are the old Working Papers "a" and "b", 3a and b, prepared for last meeting, and Working Paper 6 prepared for this meeting. We have also got some e-mail from Alfonso and Gil Meilaender that are pertinent to this discussion.

I will not reread but consider as having been read aloud the opening two paragraphs of the Working Paper 6, which reminds us of what we did last time.

I know that as people say where the rubber hits the road will be on the session tomorrow morning on the cloning for biomedical research and at least some people have said, "Look, this argument about human cloning for baby making has been settled and settled in the negative."

At the last meeting maybe there were some people silent who had other views but I thought the general view was there might be arguments still be made in favor of forbidding, which is to say not banning cloning, but the arguments in favor of the cloning itself are relatively rare notwithstanding the announcement yesterday by Dr. Zatos (ph) that he has ten infertile couples ready to go and hopes to do this by the end of the year.

Every member of the House of Representatives has voted to ban cloning for baby making and the only division is how to do it. The Academy has endorsed the same view at least for the time being. France and Germany have urged the U.N. to draft an international convention banning human reproductive cloning and the opening meetings will take place in less than two weeks. And why, someone has asked me, are we beating this near dead horse?

I think it is important to -- Janet, please?

DR. ROWLEY: I just wanted to interject.

CHAIRMAN KASS: Please.

DR. ROWLEY: Because we said last time, and you just repeated that the House vote was unanimous. It was 265-162.

CHAIRMAN KASS: Excuse me. What I said was every member voted for some kind. The substitute bill that was defeated wanted to ban on reproductive only. So on the question of cloning for reproductive purposes there was not a single member of the House who did not vote for one or the other version of a bill that would have banned cloning for baby making. That was my point. The division was as you say.

DR. ROWLEY: Okay. It was not clear.

CHAIRMAN KASS: Did I misspeak? I am sorry if I did and I think it is probably true in the Senate today that if the question is do we want to stop cloning for baby making there would not be a taker but why should we continue to do this -- Bill, sorry.

PROF. MAY:: Well, if you are asking that only rhetorically I am --

CHAIRMAN KASS: No, I was going to --

PROF. MAY:: -- going to give a wonderful rhetorical answer. I yield.

CHAIRMAN KASS: Well, I was going to, I think, explain at least to those people who are eager for tomorrow morning reasons why they have to suffer through this session.

PROF. MAY:: That is fine. Go ahead.

CHAIRMAN KASS: I think that especially for a body like this, as important as the moral conclusions are, are the reasons that are offered to justify it.

PROF. MAY:: That is right.

CHAIRMAN KASS: And that even if we were all to agree, and I do not know yet if we do, that cloning for baby making is unethical at least for the time being. The reasons we offer will matter a great deal.

For one thing, we have an opportunity not only to object to this or that aspect of cloning but to actually try to make vivid in a positive sense what it is that we are trying to protect and preserve in the realm of procreation and the care of children. And as we are an ethics council and not a scientific or medical body, it is incumbent upon us to make the large moral arguments and to give the reasoned justifications as best we can and more comprehensively than those who, as the Academy chose to do and had to do, confined itself really to the medical and scientific aspects, and indeed we have the encouragement of the Academy itself to do exactly what we are now to do.

Finally, as there is a continuum in human embryological development, so there is a continuum in the possible human interventions into that development that can and will be made. Cloning is not the last reproductive technology that we shall have to encounter, not this Council but we human beings, neither is it the last technology that can select, influence or even design the genetic endowment of our children.

It is, therefore, important I think that in making these arguments that we give justifications for our judgments that might also give some guidelines for future occasions where other technical powers are under discussion and we, again, face questions say about "engineering better children." So that, I think, is at least the Chair's justification for proceeding.

The arguments in favor of cloning children made in Working Paper 3a were clear enough, at least what they were. They might not have been elaborated with full force. And, at least, according to the discussion at the last meeting Michael Sandel said, "They were boring." I mean, they were intelligible but there was not much to discuss. He knew what they were.

The difficulties came with trying to state the moral reasons against it beyond the powerful moral reason having to do with risk of bodily harm about which we have already heard.

Mary Ann Glendon in the discussion suggested that we "lacked commonly agreed upon terms for objecting to people's free choice in matters such as these." But in response, Rebecca Dresser pointed out that "we do, in fact, have the collective language of harm where freedom may be properly constrained if its exercise does harm to someone else and then everything depends upon what is meant by harm and who is harmed and how much, et cetera."

In the Working Paper 6 that we have prepared for today's discussion the staff has chosen to regroup many of the moral arguments against human reproductive cloning made in Working Paper 3b now in the form of alleged harms. Harms to the cloned child, harms to families, and harms to the society. In doing so, obviously we have gone beyond the bodily harm to include psychic and social harm and we have even retained some objections that claim that an injustice is done by cloning per se even if no harm is, in fact, experienced. People may be violated or injured without being aware of it.

This way of presenting the matter may not express adequately the deeper issues that we discussed last time, such as celebrating the mysterious strangeness of a newborn child but I would like to see how it goes and whether this particular way of formulating the issues will work and whether it will tie in, in fact, to the normal ethical framework for discussing these questions.

My hope for this afternoon is to discover where we stand on this topic so that between this meeting and the next the staff may begin to write up our arguments on this limited part of the cloning topic with a view to some final report. So, I mean, the discussion is free and wide open but I would like by the end of this meeting without taking votes just to see where we are in general and which of the arguments strike us as being of greatest weight.

If you would indulge me just about two more minutes, I would like to try to make one -- to at least add something to the substance of the discussion, which I think will justify the tact that I have proposed here and also link up the discussion we are about to have with the discussion of the Academies report. I want to propose just a brief reflection on the issue of safety as it has surfaced in the cloning discussions. This comes out of some discussions we have had amongst the -- with the staff.

I would like to suggest that if we think about it, the concern with the lack of safety in reproductive cloning may, in fact, rest on a deeper concern for the special well-being of children, which, if we probed it fully, might in fact provide the basis for objecting to cloning even were it become, in the narrower sense, safe.

Why, one might ask, are we so focused on the safety issue in cloning? After all, there are many things that are unsafe that we allow people to practice and that we do not even seek to condemn. Many of them even affect children, indeed unborn children. People drink and smoke and take dangerous drugs while pregnant and the unborn children suffer at birth, often severely.

Children are born addicted or infected with HIV owing to the negligent or downright irresponsible practices and behavior of their progenitors. We sometimes condemn these practices, though we rarely take steps to punish those responsible and no scientific or other bodies have called for making maiming your children through drug addiction a crime.

Why do we make an exception in the case of cloning? Surely, a less prevalent and perhaps less dangerous practice than many we now tolerate or even wink at.

I would like to suggest that we rise strongly to emphasize cloning's hazards because they are integral to the very act of life giving. Anyone who would today choose to clone a child would be choosing to give that child life by means of a process that might severely disable him or her. There is something exquisitely perverse about such a parental deed. I am speaking now for myself. For those who seek to produce a cloned child it would be gratifying their wishes at the expense of not just some unrelated powerless human being but of a very special human being, their own child to be toward whom they ought to stand in the special duty-bound relation of nurturer and protector.

If we believe that a child exists largely to satisfy the parent's wishes and that it emerges as our chosen product or project, we would not be so distressed by cloning's lack of safety. The remarkable and not misplaced concern over the safety of cloning, I want to suggest, stems rather from a tacitly held but very different view of children. The children are and should be seen as gifts to be treasured and that we are duty-bound to protect them and never to violate them for our own ends.

Beneath the concern for safety lies something that might be beneath the general public revulsion of all cloning, namely an unspoken belief about the proper solicitous relation of parents for their children. If this is right, to seek to clone a child would bespeak a reprehensible indifference to the cloned child's well-being and it would follow, by the way, if this is right, that the moral condemnation of cloning, if there should be one, extends not only to the scientists and physicians who do the deed but also to the adults who would seek to have it done.

Now that is an offering into the conversation that tries to connect the safety question, the harm question, and what might, in fact, lie behind it in this case so that we could try to bring these two conversations together.

By the way, if I might ask, as a courtesy, if people would be good enough to turn off their cell phones and alarms. It does sometimes get to be distracting.

The conversation is open with respect to the arguments presented in Working Paper #6 and let's see where we are on these matters.

Michael Sandel, please?

PROF. SANDEL: I do not think we should try too hard to translate the moral concerns that we might articulate into the language, the seemingly more familiar language of safety, harm or even injustice. It is true that it is easier to make out and to defend argument in our society that have to do with harm to others but I do not think that we need to abide by that tendency in the moral culture.

I think what underlies the revulsion, commonly held revulsion against cloning for baby making, is precisely something that is best articulated in a moral vocabulary that is not reproducible to safety or harm or even injustice. I think it has something to do with the kinds of considerations, Leon, that you were just describing but why try to squeeze them into these overly -- well, to this kind of shrunken moral vocabulary of safety and harm.

If I understood the last passage of your statement, what is at stake in cloning for baby making and in genetic engineering of children and in designer babies is even if we could do it we might be able to do it in a way that did not actually do any harm to the child. Maybe not even any psychic harm but still there would be something objectionable about it because -- and here the moral vocabulary would maybe be captured by the language of corruption or degradation of norms and social practices, of self-understandings that inform the way we regard or respect or have reverence for children in this case but our humanity more broadly. We can get at this even if we look outside the area of genetic engineering.

Consider, for example, what we would think about cosmetic surgery on children that we think would help them get on better in the world. It would make them more popular, more attractive, be elected to school offices or maybe make them athletically more successful. There would be something objectionable about that even if it did not actually damage the well-being or harm the child. To the contrary, in some description it would actually improve the child's prospects but what would be objectionable about it would not be any injustice or even harm but that it would reflect and advance a tendency already powerful in our culture to see ourselves as parents or as scientists engaged in a kind of Promethean ambition of self-creation. The assertion of mastery and sovereignty as if the world and even extending to our children could be seen as the product of our own design, as projects of our will.

So it is the erosion of the restraints that are essential to the norms that constitute the way we regard childhood and the reverence that we have and so I am not sure that it -- though, we can try to crowd this range of concerns into safety broadly conceived or harm broadly conceived, it might -- we might make a bigger contribution by just identifying this range of concerns insofar as people find them persuasive as another way of describing what it is that is troubling about cloning for baby making.

CHAIRMAN KASS: Could I suggest that we now just discuss Michael's really wonderful intervention and comment because he really, I think, raises the question not only about which issue we should raise but in what kind of language, once again not now sparring over definitional terms, but how should we choose to present these questions. So could we just stay with this thing and whoever wants to speak should speak to that?

Stephen, Rebecca. Bill, was that your hand, too? Yes, thanks.

PROF. CARTER: I will be very brief because, as you know, I have to leave and I want to apologize to the fellow counselors for that.

I agree with Michael entirely but I think there is another reason, also, why we should work to -- for the purpose of today's session in the language that Michael's talking about. When we use language of safety and harm, the language is heavily freighted. One of the reasons that that is developed as the common moral language is because in American our moral arguments tend to be arguments about regulation.

So if the objection to this or any other process is put in terms of harm and safety, it automatically in most people's minds becomes a justification for a law or regulation. Now, it may be and there is certainly consensus. There is certainly widespread agreement if not total around the table. It may be that, like others, people here would favor such a ban but without regard to that it strikes me that it is very, very important to be able to discuss the moral issue without choosing language that automatically presupposes that the moral answer and the legal answer have to be the same.

CHAIRMAN KASS: That is very lovely. Thank you.

Rebecca, please. This, by the way, was partly inspired by your comment. I am not blaming you for it. We take full responsibility for it but the question was if there is a common language shall we try to deepen it or are we somehow undercutting what it is we are trying to do by, in fact, adopting it? Please?

PROF. DRESSER: Yes. By making that statement, I did not mean to say that we should limit our discussion to that framework. I am approaching our work as having a number of aims and one would be just to help people think about things that might be relevant to this problem, whether it plays into policy or not, and I certainly think concerns outside of the regulatory notion of harm are important. And, as you have said, we are a bioethics council. We are not a policy council or something so I would really encourage discussion of those kinds of things that Michael was mentioning.

I would rather that we frame this as -- or analyze it as here are a number of concerns that this procedure raises because, as I go through this list and even your example, Leon, I mean, I can think about, well, what about the couple and they know that they -- just -- I do not know if people like this exist but let's say they both have Huntington's, are carriers of Huntington's and they know it, and they decide to have a child.

Some of the concerns that you mentioned would be raised for me in that kind of a case. What kind of a decision is that? Now, there obviously would be differences as well but I think if you just focus on one single concern with baby making cloning you in most of these cases will -- people will be able to come up with, well, what about this situation where it is equivalent or equally serious concerns.

So I would rather try to present -- I do not know if this is appropriate use but cluster of reasons or cluster of concerns, array of considerations that taken all together might lead us to, you know, very seriously doubt the morality of this practice.

I guess the other point in terms of framing I would like to put is the problem in framing it as if it were safe then should it be allowed ignores the fact that we need to count what would be the cost of trying to make it safe and it is really would the goods of reproductive cloning warrant the affirmative research effort that would be risky for women as egg providers and gestators, and children, require substantial economic investment, have some of the psychological effects that we would talk about with actual baby making cloning. You know, all of these costs. So it is not just -- it is out there, should we do it but should we get to the point to where it is out there and that is a much more affirmative effort.

And so the investment there or the cost there or the concerns there should be balanced against, you know, why are we doing this, what are the goods and are they really that significant.

CHAIRMAN KASS: Thank you. I think I have Alfonso, Bill May, Paul and Jim.

DR. GÓMEZ-LOBO: I may have to go back to the harms by the way. Let me backtrack a little bit and explain how I have been thinking about these matters. In the first place I think we all agree that we live in a pluralistic society and so one of my first thoughts was, well, where is the common ground because I would like to bet that there is some common ground that would allow us to rationally reach certain conclusions in the moral domain. And I thought about the following:

I think that most people in American accept the famous principle worded by John Stewart Mill that it is legitimate to -- for the state to restrict the freedom of individuals if there is harm to others. Not harm to one's self but harm to others.

Now, many people may believe that this is insufficient but I would think that many people would accept this. Now, if that is the case then I think for a body like this it is rather reasonable to focus on harms because there is a presumption that this may be widely accepted and I personally think that that is exactly what the National Academies of Science's report does. I mean, it does not say so but clearly the assumption is that the ban on reproductive cloning or cloning for reproduction is legitimate. Why? Because of the incredible amount of risk, danger and harm that can flow from it.

Now, the thing that disturbed me there was the restriction of harm to physical harm and this constant adverbial remark "at this point, right now, for the moment," and that is also found many times in the other report by the National Bioethics Advisory Committee, and I am in pursuit of the rich bioethics that I am starting to learn from Leon. So I ask myself, well, are these the only harms there are? Can we go deeper? Is there something that we should consider, especially from the perspective of a cloned child?

And it seems to me that harm is a rather broad notion. Actually we are harmed whenever we are deprived of an important good. If someone defrauds me of my house, I would be certainly harmed because that would be taken away.

And that is why one of the things I thought about was that, and it is not the only consideration, is that being deprived by design, being manufactured by design, as an orphan, as someone who does not have in the biological sense a father and a mother but just an older twin brother or twin sister, that seemed to me to be a very important loss and worth considering.

Now, as I say, that is only one consideration but it has one advantage and it is that that is not limited to the present time. It really gives us reason to think that further in the future we should still not do this because it would be very unfair to the child.

Now let me say those are all considerations I thought about under the heading "liberty principle," the principle for legitimate restrictions of freedom in a liberal society.

On the other hand, I started thinking about another principle, which I think is probably accepted by many people, and it is the principle that no human being should be a mere instrument at the service of other human beings and I would claim that that is precisely the principle that convinces all that slavery is morally wrong.

Now, that is a principle, for instance, that allows me to take a look at the arguments in favor of reproductive cloning and, as I go down the list, I find that they really make the cloned child an instrument for something else. It is true that the child could be loved unconditionally. All those are possibilities but the sheer action of cloning children under those arguments seem to me to make the children not ends in themselves but really manufacturers for the sake of goals beyond them.

So those were my thoughts.

CHAIRMAN KASS: Thank you. We are still -- we are both speaking about the substantive arguments but also about the form in which we should be offering them. I think I have Bill May, Paul, Jim and Gil.

PROF. MAY:: I am very attracted to Michael's suggestion that we not simply try to stay within the language of harm but we think about the questions of self-degradation, self-diminution. Another way of putting this is resorting not simply to the language of guilt but to the language of shame and we have tended in the modern world, society of strangers simply thinking about harms to others but there is the whole question of self-degradation that I think we have got to consider.

In talking about cloning and positive eugenics at Yale this last semester to Yale students, I mentioned that cloning might mean -- would mean that your kids would have a lock on getting into Yale. Positive eugenics means your kids might get into Harvard.

(Laughter.)

PROF. MAY:: By trying to mock the shallowness of this ambition.

If you rely simply on the language of harm, I think you run into some of the difficulties in the paper, which basically I think is very good, 3b, but you can too easily get dismissed as speculative because you are all talking about future impacts and I notice how often "might, may, may come to" appears in the language and since we are not yet there it can be rather too easily dismissed as speculative.

Whereas, if you talk about self-degradation and self-diminution, it seems to me, you are appealing to self-perception and that is one of the things I liked about Gil Meilaender's paper. He set up the sense of human nature that allowed us to see what we were doing by way of self-diminution and self-degradation in moving in certain directions and not just guessing about the future, which might be too easily dismissed.

On the question of safety, I was very touched by George Annas' paper where he talks about the whole problem of crossing a boundary. And one does not do full justice to the problem if one simply talks about the possibility of damage to those which is perpetrated in the course of getting across that boundary but rather forcing us to look at that land into which we propose to enter. Its impacts on parenting. Its impacts on being a child. Its impacts on being a sibling and so forth. And something you can address, it seems to me, to people, speaking not entirely within the context of a Calvinist tradition that says our nature is utterly defaced but there is a possibility for us to recognize that that is not what, as human beings -- that is not the kind of world into which we ought to enter.

Now, my own feeling is it rests on safety alone then an awful lot of research will be in the direction of making it safe and so one encourages the slippery slope. Whereas, if there are other arguments, powerful arguments, compelling arguments for saying that is a country into which we ought not to enter, it might -- if we really sense the power of those arguments and presented a paper that made this clear to a nation, it might, in fact, make it more possible to engage in research without constantly facing the problem. We are merely greasing the skids into moving into that kind of world.

CHAIRMAN KASS: Thank you very much. Turned the page and lost the queue. I had, I think, Paul. Paul McHugh and then Jim.

DR. MCHUGH: Well, wonderfully eloquent things have been said this afternoon and it justifies you, Leon, having us discuss this matter even though it may be a foregone conclusion. I want to follow up on Michael and support it, as have others, but I also want to remind us of what Charles said last time we gathered. He said, "Whenever you do not want to do something, you have got to give really a clear answer as to why you hate something or want to stop it in a democracy."

And I want to just tie this further together and say, "I think human reproductive cloning is an infringement on human dignity." As simple as that. The degradation side takes from human dignity. It does it for three reasons, I think.

First of all, I think that the very idea of manufacturing a human being is a degradation. We are not manufactured. We are created.

Secondly, copying denies the special individuality that each of us has as a human being special in the creation.

And then, finally, the thing we may not be talking enough about is that for each of us we have a source in a lineage of human affection, expressed sexually usually most of the time, and that very much denotes an aspect of our dignity as we are the offspring of some very special people who in love are connected in a long lineage to others, parents, grandparents, in that way, but also siblings, cousins and the like.

And I think human reproductive cloning denies human dignity for those three reasons.

CHAIRMAN KASS: Jim Wilson, please?

DR. WILSON: I agree with Michael. I agree with Bill. I agree with Paul. I think these are all important arguments and I agree that we have to state the argument against reproductive cloning in the strongest possible terms, of which safety must be an issue but not the dominant issue.

However, having said all this, I want to suggest that in Working Paper 6, Section B, where there are five arguments raised against cloning, two of them strike me as implausible. They may not be wrong but they are implausible and before we adopt them or urge the staff to flesh them out, I want us to think about why they may be implausible. These are arguments (a) and (d):

Lacking concern for the physical, social and psychic harms that might be inflicted on the child." The parents might regard it as an "it" and somehow expendable.

And in (d): "The practice of cloning children would set a precedent for treating children as artifacts."

Now, the reasons those arguments to me are implausible is that they are predictions, empirical predictions as to what would happen. It may turn out that they are true but there is a counter argument that has to be considered. A child born from a mother, however the embryo was first planted there, by sexual reproduction, by in vitro fertilization or by cloning, the child appears after the normal process of parturition. And, except for a, happily, tiny minority of women in this world, the child is their's, it is to be cherished, it is to be loved, it is not an artifact, it is not expendable.

Now, it may turn out that cloning will alter that developmental process and it may turn out, therefore, that I will be wrong to be suspicious of these arguments but I do not think we should push these arguments because it seems to me they fly in the face of everything we know about human birth.

CHAIRMAN KASS: Thank you very much. Gil, and then Michael?

PROF. MEILAENDER: I am still coming back to Michael's original -- Michael Sandel's original comment, with which I agree if its point is we want a richer argument than just questions of safety. I am not sure I took it as sort of an accurate reading of the Working Paper. Okay. And I have no particular stake in what the best way to structure the argument is but I do think it is worth thinking about if one -- if rather than trying to structure it sort of the way the Working Paper does, and I will say a word about at least how I took that to be in a minute -- if we simply try to develop several kinds of reasons for concern.

One would be the safety and physical harm, and then there would be some of these other reasons having to do with the relation between the generations and so forth that you are talking about. I mean, one problem with that is that actually it makes it rather easy to make what is the very common move, separating them all and say, yes, the harm is a problem, these others, you know, they are interesting, they are symbolic questions about which we might agree or disagree. I mean, I just predict that in a sense a collection of concerns lends itself to that and that is what made me think about -- think favorably about the attempt of the Working Paper to structure it this way, though as I say, I mean, I have no deep stake in it and can persuaded otherwise.

I took the fundamental category of the Working Paper to be not harm but injury and that one could be injured in two sorts of ways. You could be injured by being harmed and you could be injured by being wronged. And being injured by being wronged, though I mean it is not fleshed out and, in fact, they use the language of injustice here but it seems to me that if you were to flesh it out, one would begin to do some of the sorts of talk that you were doing but you would still do it within a general structure that said cloning would constitute an injury and that there were several possible kinds.

Now, as I say, I do not know but as a structure that did have some appeal to me and I did not think of it as excluding what I grant are some very important and richer kinds of concerns.

CHAIRMAN KASS: You are a good reader. I think, if I might just interject, there was partly an attempt -- the remark on safety that I offered at the beginning was no part of this. It was an addendum. The part of the point was to enlarge the understanding of harm and even Bill May, when he spoke about degradation, talked about the impact upon, and I take it impacts can be good or bad and bad impacts are forms of harm if harm is a fat enough category. I mean, that is a kind of consequentialist analysis but we did include here a category where someone could be done an injury whether they know it or not and whether they experience it as a harm. And there was only one example here but it seemed to me a number of the things that Michael has raised could go in there.

Welcome, Mary Ann.

Partly it is a question of how does one address -- and this was, I think, partly Alfonso's point -- how does one address the moral language, which is the common language of the community and do we make a mistake if we simply avoid it and go our own way? That seems to risk doing bioethics in a non-rich way and foregoing the opportunity to develop the arguments in the spirit in which we talked about last time and the way in which the Working Paper does but I think we did leave room in here.

It was not to be an exclusive reduction of all things to harm but to see how far one could get with that kind of language and what would be left over. Now, it might be both intellectually and pedagogically a mistake but that was the intent and it was not meant simply to straight jacket those things.

Michael Gazzaniga and Charles.

DR. GAZZANIGA: Well, I think there -- I mean, when we send up the horror flag on reproductive cloning, what we are really offended by is the notion that some person wants to reproduce themselves. So we are mad at the adult, no mad at the child. The child appears, it is a baby. Everybody loves a baby.

And I completely agree with Jim Wilson's assessment that we get on very dangerous ground if we are going to start worrying about the psychological state of the baby. The baby will be accepted by the community. Agency will be conferred to it. That is what our species does. We confer agency immediately and the baby has just as good a chance of growing up to be normal as anybody else.

And I think by not making that clear distinction, the committee in the report has the potential of offending every parent who has adopted a child in the country because in a sense there are many parallels between parents who have adopted a child. They pick up a baby. It was a baby that was put up for adoption by another couple that did not want the baby and all these sort of parallels can be drawn.

So I think it is very -- I think we should be very careful about where our anger is. Our anger is not with the child. Our anger is with the precipitating.

CHAIRMAN KASS: Very nice. Who was it? Was it Charles, and then -- I have lost the queue again. Charles and Frank and Michael?

DR. KRAUTHAMMER: I am not sure the basis for our revulsion is anger. I think it is horror and I sort of agree that it is somewhat restrictive to speak only in the language of harm or injury, although I think the point that it is the common language of the Millean (?) universe in which we live. It makes it rather advantageous in terms of appealing to a broad democratic polity. Everybody understands the basic rule that you can be intercepted from doing something and prevented if it is going to harm others.

So I would not be opposed to harm or injury as the rubric. All I would do is to try to say that we should not focus exclusively on the harm to the cloned child, which appears to be what almost all of these instances in the paper are about for two reasons.

One is because all of the arguments could in the end be collapsed by the counter argument that, well, at least it is living and the alternative is never to have lived at all and perhaps even for all of the harms it is here and if we are asked the choice it would rather be here harmed than never have been created in the first place, which is the argument that one has about severely disabled or damaged newborns.

So, I am a little bit concerned that if the entire argument hinges on harm to the cloned child, it could be completely evaporated by the counter argument that, well, harmed or not, he is here and you would have prevented his very existence. That is the worst harm.

So, I think, we need to broaden out the concept of harm and to speak of harm to society. That is harder to do but it has to do with what would life be like in a society in which (a) you could manufacture children, you could program them, you could design them, and you could design them as copies without individual identities. And that is -- Huxley did that rather well so we are a little bit late catching up with him but he showed us what it would be like and I do not think it is a very hard thing to do, is to elaborate that kind of dystopia to actually distill it into arguments about what is wrong with such a society.

So, in summary, I would not oppose the idea of harm but it should not be exclusively on the child or we are at risk. It should be a broader one.

And one other -- if I could just add one point. The National Academy report is extremely and consciously restrictive. It focuses on a single kind of harm, that is the harm of physical harm under the Nuremberg rules and it consciously punted all the other harms, all the other ethical arguments to us. I think it would be extremely important to elaborate precisely what they had consciously left out because I think it would establish the argument in the national debate in a way that would be extremely important.

CHAIRMAN KASS: Thank you very much.

Frank, and then Michael Sandel?

PROF. FUKUYAMA: Well, I am not so sure that you can collapse all of the arguments about harm to the child just on the counter argument that it is better to be alive because, in fact, a lot of, you know, this research into genetics is designed precisely to prevent, you know, that kind of outcome, which I think there is a broad consensus, you know. Even if the child does not, you know, articulate, you know, the thought it would better for me not to have been born -- you know, I think a lot of people would say certainly, all other things being equal, it would have been better if that child had not been born, you know, with that particular defect.

So I think it is legitimate to -- you know, quite legitimate to lay out the harms. My view of the problem with the -- I think the way that scientists deal with the question of harm, in general, is that it is a kind of lowest common denominator. It is always harms to the body and only rarely includes, you know, psychic or social harms.

As a social scientist, I feel perfectly entitled to talk about all this sort of thing, I mean, but, you know, a scientist is very reluctant, for example, to take a position on whether it is good or bad for the child development to be born into a single parent family. That is something that actually social scientists have been debating and it is something that can be, you know, I think, empirically addressed and I think that my preferred strategy is actually to begin from bodily harms but to expand the notion of harms to say that there are other kinds of psychic harms.

I mean, in my view actually, you know, one of the greatest psychic harms is, you know, the confusion of authority roles in families in ways actually that, you know, invite incest and, in fact, as I was thinking about it, you know, in the last session I made the comparison, a restriction on cloning is in a way sort of parallel to our existing restriction on incest. But the more I think about it, it actually overlaps to a, you know, substantial degree.

You cannot empirically verify this until you have a big population of cloned children but I think that there is probably a lot of existing social science research on who commits incest and where child abuse among other things happens. It happens among nonrelatives living in families that this kind of relationship actually would invite.

And I think that you can, you know, kind of make a very kind of social scientifically informed argument that you are opening the path to a fairly predictable set of harms if you -- psychic harms if you permit this.

CHAIRMAN KASS: Michael?

PROF. SANDEL: I would like to speak against pandering to Millean assumptions that may be widespread in our society. There are times -- in fact, most of the time when we are trying to persuade or engage in political argument that we have to try to fit our arguments to the moral vocabulary that is prevalent because otherwise we would not be able to get agreement.

This is a different kind of case that represents a special opportunity because here we have agreement. We have agreement so it is not the problem of saying, well, can we find a common denominator of moral vocabulary and fit that for the sake -- we have the agreement that cloning is undesirable so we have a special opportunity to engage in moral and political -- moral education to that aspect of our role. So of all cases where we might find ourselves, this should not be one of them.

This is one where we should feel free as a Council to do our best to articulate the full range of reasons, of human considerations, moral considerations without feeling the need to pander to Mill's own principle because it is widespread. The revulsion that there is, the unarticulated revulsion gives us a chance to try to do what the public has not on its own been able to articulate, the sources of the revulsion, which may shift the moral vocabulary for other purposes in public discourse.

CHAIRMAN KASS: It sounds to me -- two things. One, it sounds unanimous that while there are some people who say we should not simply eschew the language of harm where it is useful, that we have an opportunity here to do much more, and that the way we chose to struggle to talk about these things the last time is in a way the right way to try to develop that.

Is there anybody who wants to dissent from that because if that is where we are, I propose the following: That we are ready for a short break and that we come back and actually try to dig in. I mean, Paul McHugh has actually made a substantive claim about what is wrong with this and laid certain things down. Others at the table have done as well.

Also, one other thing that we should not forget to do because -- and someone reminded me of this at lunch, just because we seem to fit, most of us, with the general public sentiment does not entitle us to be unfair to any arguments that could be made in favor of cloning. And it seems to me that before anybody sets anybody to write anything, it seems to me that side of the discussion also deserves to be heard.

So, unless somebody wants to dissent from the consensus started by Michael as to how we should speak about it and what kinds of arguments we should make, I will take that as the sense of the group and then we only have to figure out which ones. Is that all right with everybody? Any dissents from that?

Michael, you have done us a great service and so has everybody else who has elaborated on that.

We are short of 3:15. 3:30 sharp. We will go until about 10 to 5:00 and at 5:00 o'clock we have the legal ethics session. Thank you.

(Whereupon, at 3:12 p.m., a break was taken.)


SESSION 4: HUMAN CLONING 7: ETHICAL ISSUES IN "REPRODUCTIVE" CLONING

CHAIRMAN KASS: All right. Before we actually return to the discussion, I take it, our task now is to try to articulate which of these arguments we find most important and most compelling. Again an invitation, somewhere between an invitation and an exhortation, that on this topic as well where we will, I am sure, not conclude in detail, when you go home and before it gets cold, several pages, if you can, on which of the arguments are most important as you see it and I am not promising that we will simply count noses at the end but the language that could be created from the people in this room will certainly enhance whatever it is we finally put together, at home and the staff.

So, now, in the next couple of weeks would be just a wonderful time to receive further reflections, elaborations, things that occur to you after the meeting that are pertinent to this and, by the way, for anything else that we do. The comments we have gotten so far have been very, very helpful and, I did not mention but you have in your booklets, Alfonso's comment on supporting a ban on cloning to which he adverted in the comment that he had made before.

Janet Rowley has asked to lead off in this discussion and we will then try to do what Michael has invited us to do.

DR. ROWLEY: Thank you very much. I want to follow on with the tact that Jim Wilson was taking and just preface that by saying that I think it is extremely important that as we come down with the discussion of the reasons that we might be opposed to reproductive cloning that we make them as plausible as possible and Jim used the argument that certain of the comments were implausible and they diminished the strength and the validity of the arguments that we might put forward so that I think that that is critical and there are a number of other implausible arguments.

And I think that the point is, particularly if you look at 3a from last time, the reasons for reproductive cloning. The first five reasons on page 3 of Working Paper 3a are, I would think, potentially valid reasons for a couple to want to have a child that would be a clone potentially of a child that was dying and that child was very precious and through that, even though we may think they are misguided, they would like to continue that child in another offspring.

So I think that it is critical that we be as thoughtful as we can. The child that would be born would, in fact, be a child that the parents very much desire so I think that things that say this offspring is going to be treated as a social outcast is highly unlikely because when you really look at this in a realistic world there may be nobody but the parents who know how the child was derived and, therefore, society is not going to treat this child differently from any other child.

So I think it is critical that each one of the reasons that we look at be ones that we feel are valid concerns and there I do think that many of the reasons enumerated in the report of the National Academy and much of what was in some of the earlier working papers that do stress the lack of safety and the potential harm to the parent, and I am certainly willing to include harm to the fetus because of the technical nature of that individual's early state that those are certainly perfectly valid reasons. As well as some of the other ethical reasons that, I believe, will come forward from this afternoon's discussion but we also, I think, have to make sure that we do not phrase them in a way that reflects our own individual bias but try to make them as broadly applicable to people of varying backgrounds as is possible.

CHAIRMAN KASS: Thank you very much.

Janet, I know that you have -- from private conversation -- think that at least some of those arguments in Working Paper 3b are problematic and if -- it need not be now but if you -- if not now, certainly when you get home we would love to have your suggestions as to which of those things strike you as implausible or speaking improperly.

DR. ROWLEY: I have my comments on all the working papers of the first meeting right here and I will speak with staff about them.

CHAIRMAN KASS: Terrific.

Well, now that Michael has told us that we have to bell the cat, Charles is ready to step to the plate as usual.

DR. KRAUTHAMMER: No, I just want to bunt.

(Laughter.)

DR. KRAUTHAMMER: Which is to pose -- maybe we could start by -- with a kind of counter argument in favor of cloning or at least a way of saying that there are analogous situations in noncloning situations which work out okay. Earlier we heard that we have to be careful about emphasizing the lack of loving parents or of biological association with the parents lest we offend people who adopt, and it is not only a question of offense, lest we contradict evidence that you can be a child who is adopted and loved.

Let me ask that regarding the production of a child who is a copy. We have the accidental production of copies in biological twins. How harmed are they and if we base our argument on the harm of being a copy, how can we contradict the evidence from real life that twins or triplets generally are no worse off than anyone else and actually have special experiences and joys that some of us may not even know?

I know the big difference is it is a delayed copy but perhaps in fleshing out it is a copy of a lived life rather than two copies emerging un-lived but perhaps we could -- someone could elaborate on that as to what the -- what is it that repels us about the making of a copy if we are not repelled by twins?

CHAIRMAN KASS: Jim?

DR. WILSON: I think to a first approximation that the crucial difference lies in this: Twinning, which occurs very rarely, is an accident. We have two eggs. One egg becomes two eggs and they are genetically more or less identical. But copying means taking somebody that you know, an existing child, Raquel Welch, Arnold Schwazenegger, Michael Jordan, the guy next door, your grandfather, and trying to copy them.

The issue then is that the first category falls within the realm of the mysterious and wonderful surprise. Though, not every parent is delighted to push two babies around in the baby carriage at the same time, most measure up to the task admirably but designing somebody to copy somebody else is a more complicated question.

Janet said, "What if you are trying to copy a loved child who now has a terminal illness?" Well, that is different from trying to copy a sex goddess or a basketball star because you want your child to look like them. So somehow -- and I have not got the words in my own mind -- we have to make these distinctions so that twinning is one case, possibly copying a terminally ill child that you want to preserve is another case and copying somebody because you admire them or want your child to look like them is a very much separate case.

And my objection to cloning, which I initially did not have but Leon Kass talked me into having, was, in part, I could not figure out a way to select how you would select the clone without opening up this Pandora's box in possibilities of designing children -- of making children objects in some sense but I think twinning is different from these other cases. I do not have the language to explain clearly why the differences exist but they are different.

CHAIRMAN KASS: Let me lean on what you have said in response to Charles because Charles wanted you to focus on the copy and you focused on the design by choice rather than by accident so that to -- just to draw you out, one could imagine that -- and forgive the science fiction of this but one could imagine that in some future day a child would be designed not by cloning and would not look like anybody else at all. It seems to me that the point that you have now made stands and the cloned relation disappears.

DR. WILSON: Are you talking about, in effect, genetic engineering? Designing from scratch.

CHAIRMAN KASS: Yes. Is the problem here that the child is the product of will and selection or is there something added because it is a copy -- "copy with an asterisks", we will speak shorthand. It is not an exact copy but is somehow an attempt at a copy of some other being.

DR. KRAUTHAMMER: I raise it because -- excuse me, Jim. You know, on page 1 where we have the paragraph under "A", the cloned child, in italics we have "experiments in human identity" and then "experiments in programming." I am trying to --

CHAIRMAN KASS: Separate these.

DR. KRAUTHAMMER: -- tease them out.

CHAIRMAN KASS: Yes.

DR. KRAUTHAMMER: And to say leave out the fact that the programming here, which is in itself a moral problem. Let's just talk about the experiment in human identity, which we have had in natural twins. So how does -- why are we offended and why do we object?

CHAIRMAN KASS: Did you want to say anything more, Jim, or not?

DR. WILSON: I am not sure I have my thoughts well enough in order to say anything at all but the parents do now in many cases go to some length to produce "the right kind of child." We begin with assortative mating that men and women of roughly the same educational level, often roughly of the same personality and political orientation, sometimes of the same athletic background are more likely to get married than people who have none of these things in common.

Now this may -- this is, in fact, the result of drives that may, in fact, have nothing to do with child bearing but they do, in fact, affect child bearing because it increases the probability, though far from the certainty of having a child that will to some degree emulate the parents.

The deliberate design, however, or engineering of a child to produce some template, it seems to me, is a very different matter. First of all, it strives towards a kind of certainty that people I do not think should exercise over children. Secondly, it creates the risk that if you make a mistake, that is to say in your engineering plan, you will hold it against each other as parents or against the child. And, thirdly, though this is not any concern to the parents, it reduces biological diversity in a way that is harmful to the human race.

CHAIRMAN KASS: Michael, and then Janet? Janet, did you want to respond directly to this?

DR. ROWLEY: Yes. You see, this is where I think we have to be very careful that we deal not too far in the future and I think that to the extent that we can avoid too much of eugenics in our discussion we will end up having a report that will be far more acceptable to the -- not only general educated community but certainly to the scientific community.

Irv made the point that we are all genetically defective so it has been estimated that we all -- seven percent of our genes are defective genes. Now they may only -- that defect may only come out if you are stressed in a certain way or if you live to a certain age and then those genetic defects become apparent but the notion that somebody in the future is going to be so knowledgeable that they can put all of the genes together in an embryo and have them all be nondefective genes is so vanishingly small as to be nonexistent. And so I believe, again as I asked earlier, that we have to confine ourselves to things that are really going to be biologically relevant.

CHAIRMAN KASS: Comment? Bill, please?

DR. HURLBUT: I affirm what you say but I think you should take it even one step further and say that to even define a gene as defective has a huge variation of context implicit in it.

CHAIRMAN KASS: Could I get a point of clarification from you, Janet, because it does bear on the way in which some of us at least have been thinking about this? There are at least some people, and some of them, in fact, scientists insofar as they write for public consumption, Lee Silver would be one name that comes to mind, who talk about, and talk rather optimistically, not about getting rid of all of the recessive -- mostly recessive genes that we carry but talk about things like genetic enhancement privately practiced.

I mean, I think probably a fair amount of it is overblown but are you suggesting that we really should not even put on to our conceptual horizon genetic intervention based upon genomic knowledge that might actually come under the heading of enhancement, whether it be for simple things like height? I mean, is that off the table?

DR. ROWLEY: Well, all of these things are going to be multifactorial and how many genes are involved in the determination of height I am not very certain. I mean, I am totally uncertain. And in many of these areas it is really the interaction of two genes so one gene is not enough. You need two. And in some circumstances I think there is evidence that you need more than two. So how you get the constellation of all the right genes out of the 30,000 or so that we have in our cells, you know, I think is just such an unlikely event that to be bringing up these as rational, valid arguments against cloning, we run the risk of undermining our report.

CHAIRMAN KASS: Thank you. Dan?

DR. FOSTER: I certainly agree with that. I mean, you know, the crude estimates are that every gene has at least three messages because of, you know, each message has, you know, somewhere around three proteins that is going to -- I mean, those are minimal estimates. So even if you know the genome you have got, you know, multiplied possibilities and trying to put all that together is difficult.

I do not think we ought to confuse the issue of genetic enhancement, particularly -- I mean, you can do that somatically. You know, people have said that in gene therapy you have got to worry about whether you use nuclear RNA or mitochondrial RNA, and whether you are going to do this for therapy or enhancement and so forth. I mean, you can get all those models.

But there is a much bigger problem if you are talking about gene therapy in the germ cell. I mean, whether you are doing somatic or germ cell because that is not just in one cloned individual. That is going to be passed down, you know, throughout the whole tree after that. In one sense I think that the, you know, germ cell therapy, although for sickle cell or something like that it might be worthwhile doing it, that is a much more serious problem than cloning.

In other words, I do not think we ought to complicate the issue of cloning, which is before us, with cloning plus gene therapy and enhancement. I mean, I think those are -- that is a vastly -- then it becomes vastly more complicated than the already complicated issue.

And the only other thing I want to say in passing, I agree with the view about trying to say in fairness there might be certain circumstances where cloning could be justified. I am not sure of that myself that it could be but there also is the issue that -- of catastrophic damage to the race, you know, so that there are only a few survivors. Let's say that there was a widespread, you know, dinosaur-like collision on the earth or something. You could conceivably say that the technology of cloning, if there are enough survivors to have some diversity, that that might be life-saving for the universe, at least the human universe. Now, I think that is very farfetched but, I mean, people have brought that up.

My main point is that I do not want to confuse genetic engineering and germ cell genetic engineering with cloning. I think that will make it so complicated that you cannot deal with it.

CHAIRMAN KASS: Yes. I think the only reason the question comes up -- and gene therapy is off the table all together from the discussion here but there are some people -- in fact, the testimony has been offered that in some ways cloning is the first of a series of possibilities where genetic knowledge, in fact, maybe even much more precise genetic knowledge than cloning, which is, after all, crude. You pump in the nucleus, you do not really know what you have got in there. If one had more precise genetic knowledge, one could, in fact, start down the road to "designer" children.

And I take Janet's point exactly that if this is on the horizon it is out there but if we are here going to be talking about that, what is objectionable here is that somebody is doing designing or engineering not for therapy, not for therapy, then at least those -- at least conceptions of the possibility of genetic enhancement are part of the way people have been talking about it publicly. That is why it has entered into the discussion.

And if it turns out to be -- if it turns out that we could do a surface by pointing out that this is for the moment just smoke and mirrors and very unlikely, that would also help. I mean, that was -- I was not suggesting that we take up gene therapy at all.

DR. KRAUTHAMMER: Could I just add one sentence on that. I think you are absolutely right. Michael's point that this -- our unanimity and societal unanimity on cloning -- offers us an opportunity to make a moral argument is important here. Designer genes and designed humans could be decades, centuries away. But, as Leon said, cloning is a crude first case. It is a completely designed human in a sense because it is a copy of something that we know.

So by making the argument against design now with this, we establish a principle that can later be applied if and when the other becomes a problem. So I think it is useful to do it even though obviously the actual advent of that threat is very far away.

CHAIRMAN KASS: I have the two Michaels, Sandel and Gazzaniga and Bill.

DR. HURLBUT: This is relevant to the direct thing you are talking about.

CHAIRMAN KASS: Okay, please.

DR. HURLBUT: I think we need to be careful not to object to cloning on the basis that we are going to produce an identical copy because I think -- Leon and I had a little talk about that in the break and I think I disagree with Leon's understanding of genetics but my thought of this is that we have to avoid doing what has been called "genomic metaphysics."

I have an objection to some of the working papers that imply that a person is their genetics. I do not think there is any real good scientific evidence for that and I think there is a little bit of evidence at least to go the other direction that, in fact, what you have to avoid in this discussion is what Steven Rose calls the "nuclear board room" where the cell is completely controlled by the nucleus.

In fact, what he calls "molecular egalitarianism" is more to the point. The cytoplasm actually affects the gene expression a lot and that is why when you put a different nucleus into an oocyte you are not going to get the same thing as you did from a split oocyte, the split zygote that produces identical twins.

And then there are about 50 good reasons that I could go through that show you why even identical twins from an original cell are not the same and this has to do with things ranging all the way from the lack of concordance of twins to the very real differences that there are in twins that you would not think would be there, like differences in handedness, differences in swirls in the hair, differences at the expression of diseases. I know of a case of Huntington's disease where twins, identical twins, had a difference of expression by ten years. And there are identical mutations in cystic fibrosis where they have completely different phenotypic outcomes.

The point is that a clone is not only going to have just those differences. It is going to have the differences of the accumulated somatic mutations in the nucleus it is placed. It is going to have the differences potentially of the mitochondrial differences. It is going to have the differences of the gestational effects of a different mother at a different time or so forth. There are just so many differences.

Just because they can make a cow that produces a substance in its udder that you can milk out as a pharmaceutical, one gene -- sure, there are going to be genes that are direct impacts on phenotype but most of what we really care about for which we would do cloning, issues of performance or appearance and so forth, those are going to be what are called quantitative trait loci with many, many genes entering into them, and be probably way beyond our bioinformatics for many a decade at least, and maybe forever.

CHAIRMAN KASS: Michael and then Michael?

PROF. SANDEL: I do not think we can entirely disentangle cloning as a copy and cloning as making a designer baby. It seems to me that what is objectionable, the core of the moral objection to cloning, is not that it is a copy but that it is a copy by deliberate design. A copy of a particular other person. The parents want this clone because it is a copy of some particular other child or other person with some characteristics.

Insofar as that is a motivation, then you cannot completely separate the objection to cloning from the objection to genetic engineering and designer babies. You could try to distinguish to see what is doing the moral work in our worry. You could imagine two hypothetical scenarios to isolate these two features of cloning.

You could imagine a group of parents who have failed at an infertility clinic of a conventional kind and who go to one that specializes in cloning. They clone babies but the baby they take home is assigned at random behind a veil of ignorance. They do not get the one that they cloned.

Compare that practice on the one hand, which involves cloning but does not involve a child with characteristics that you have chosen and identified and designed in advance so the mystery, the uncertainty is still present. The hubris of actually deliberately constructing a child with certain characteristics is not present because you do not know which one you will go home with.

Compare that scenario with another scenario where there is no cloning, where there is a natural -- a pregnancy begins, a couple conceive a child, and during the course of the pregnancy, let's say the mother is able to take some kind of pill that can select for the sex, the height, the physical strength and the intelligence of the child. So there has been no cloning.

Which of these two practices would you find most objectionable? It seems to me the second. And the reason we would object more to the second than to the first is that it has all of the things that we have talked about here, the hubris, the treating of the child as a project, as an object of manufacture, removal of mystery, all of that would be present without any cloning so it is not the cloning as such that carries the moral graviment here.

It is the deliberate design, the genetic engineering that flies in the face and erodes the proper way of regarding and revering and treating children and instead sets up the deliberate choice of characteristics.

Now, it could be argued that there -- people will argue we do this environmentally. We select for various characteristics, not only by the marriage partners but also in trying to enroll kids in special classes that will enable them to get 1,800s on the SATS even if you do not genetically engineer it or who will be good at sports and giving them special advantages but insofar as those -- that should not be a comfort to those who would support cloning.

To the contrary, the very fact that cloning babies by deliberate design carries forward a logic of a practice we are already engaged in, is all the more reason to oppose it and all the more reason to rethink the tendency implicit in the current environmental manipulation of children that regards them as projects and their success is a measure of the parent's worth and so on.

As, also, creating dispositions -- Mary Ann last time used the term "the insensitivities that induce desensitizing" to the mystery of human nature and in the case of the child's nature.

CHAIRMAN KASS: Michael Gazzaniga?

DR. GAZZANIGA: I would like to go back and pick up a couple of threads here. The emphasis that I think we should stick to the safety issues is a very serious one because we are on solid footing there and the minute we drift off into the psychologizing of the interaction of the clone with the parents, we are not on firm ground.

There is -- built into this conversation is this thought that the clone is a copy and, of course, we all know from thousands of identical twin experiments that you can look at twins as a glass half full or half empty, that there is a tremendous concordance rate with disease intelligence, psychopathologies, and yet there is a tremendous individual variation, too.

So the probability that a cloned child would be not a chip off the old block but the old block is just wrong. It is just -- there is going to be tremendous variation there and it might dissuade people from even thinking about it if they really looked at the twin data and saw how much variation that will undoubtedly occur.

But, Mike, what you are scared of on the selection business of a baby-building, I learned this week, to my great surprise -- I think it was generally known by those people who worry about these things -- if you do a couple of clicks on Google after you look up "IVF" you get yourself to a clinic and you type in exactly what you want in your spouse, hair color, level of education, height, athleticness, what part of, you know, America did they go to school in, and bingo comes back a list of eggs that they have ready to go. Egg 418 looked pretty good to me. It has all the characteristics that you might think you want in your spouse. It is here. They are doing it on a daily basis.

So this sort of, you know, ringing our hands about this is -- it is here.

PROF. SANDEL: Just briefly.

CHAIRMAN KASS: I think Michael wants to say something to that.

PROF. SANDEL: Michael, I want to respond. My response is that is just as appalling as cloning.

CHAIRMAN KASS: Rebecca, and then I have Gil and then Robby.

PROF. DRESSER: I think we do need to think about what we might say in response to some of these arguments for reproductive cloning and two of them talk about infertile couples who could -- I mean, say you have a man who is sterile so the only way that they could have a child who is biologically related to the husband is through cloning. Also you might have a situation where the only way -- I mean, people who do not want to engage in prenatal screening or pre-implantation screening might say, "Well, this is the only way we could have a healthy child and this would allow us to avoid donor gametes. Our goal is to avoid donor gametes."

What would we say to them in response besides, "Well, currently it is unsafe and I do not think we should invest the resources into making it safe"? But this is a variation of the arguments people have used for other kinds of infertility treatments so I think we need to think about what we would say.

I guess the other point is these parents who would like to produce a child to replace one who has died prematurely. I mean, people have said, "Well, they are misguided." But I think we would want to go into some of the reasons, in a sensitive way, why we do not think the child can be replaced and I do not know how many of you read my friend, Tom Murray's piece in the Washington Post about replacing a child through cloning. It was really one of the most powerful pieces I have ever read about why this really would not work and I think we should look to that as a reference.

DR. ROWLEY: Can I just respond? I would like to just respond to the first one. So if a husband is infertile, the wife wants a child related to the husband, of course if it is cloned then it is not related to her. So that is the trade off she is going to have to make.

CHAIRMAN KASS: She gets to deliver it you see.

DR. ROWLEY: She would carry it but by cloning she has no genetic contribution to that child and that may change the situation.

CHAIRMAN KASS: To this, and then Gil is going to hold on? Go ahead.

PROF. FUKUYAMA: It is an interesting point that you raise because there are sympathetic cases where you can, you know, I think fairly easily justify cloning. The question is do you ban the whole? Do you permit the whole category of actions, including the nonjustified cases because you can find some justified cases or you can reverse it? I mean, just because we can think of some harms, do you then ban the entire class of action, that it could include certain, you know, beneficial things because you can identify some harms to some individuals? There is an intermediate solution to that which is actually to permit it only in, you know, certain cases.

For example, I mean, this would apply actually to the research cloning as well if some rich entrepreneur wanted to clone himself and give the embryos out as party favors, I mean it is a pretty gross thought but, you know, you could imagine some guy in Silicon Valley, you know, doing that as a joke to stick it to the antiabortion people. I mean, presumably even the, you know, supporters of that, you know, would not want to see that happen so that is another possibility is you could actually try to distinguish between legitimate and illegitimate uses of the procedure.

CHAIRMAN KASS: I have Gil, Robby and Mary Ann.

PROF. MEILAENDER: A word to Michael Sandel's comment before but then mainly I want to express how lost I am. I would hate to have to make the choice, to be asked to make the choice that you gave us about which of those two things was somehow worse, Michael.

It seemed to me that one thing -- your worry about the control and the hubris and so forth, I mean, that does capture one aspect of the concern about cloning. It did not capture anything about the issue between the relation between the generations, however, which is, you know -- I mean, maybe you do not think that is a powerful argument anyway but, you know, that would be a concern about cloning even in the hypothetical case where the hubris could not enter in because you did not get to pick your own, pick which one you took home sort of so that there are other considerations that would enter in, I think.

But then I -- you seem to me -- did I say something really stupid that you are smiling about?

CHAIRMAN KASS: No, I am smiling because I am going to appreciate what is coming.

(Laughter.)

PROF. MEILAENDER: Well, you just seemed to me to have ended the last session very optimistically now because at least my understanding of your summary of -- your understanding was that we had some kind of agreement that whatever exactly we call this,cloning for baby making, that that was a bad thing, that we were going to try to think about the arguments, that was one thing.

And that, second, we were going to try to think about the arguments in this rich, thick way that Michael had urged us to think about that was not reduced to considerations of safety alone.

And it seems to me now that the reported consensus on both of those things has broken down and I am just -- I am not sure where the conversation is.

CHAIRMAN KASS: Yes, we have had an attempt in an exchange about whether it is copying or manipulation that is troublesome. As soon as you mentioned copying there is lots of screaming that it is not really copying anyhow and that is the most important thing to say. I wish I remembered to ask Irv Weissman about this because almost a couple of lines away from saying that the clone, of course, is not going to be identical and all kinds of environmental factors, and I am sure Bill is right about that.

There are also remarks that cloning is a wonderful way of replicating animals for their uses and surely you do not have to be a genetic determinist to think that if there was nothing in this, if the genotype did not somehow matter enormously, this would be a -- you know, a dead end all together even in animal cloning but -- so the copying thing breaks down. There is some worry about whether manufacture or manipulation is really an isolated case here or whether it is generalizable to other things.

And listening to all this stuff go around, sensible Michael Gazzaniga says, "Look, safety. That is solid. The rest of this stuff is..." you should excuse me "...speculation."

So I am going to fly Michael's flag again -- and Janet, by the way, has called attention to the fact that at least some of the arguments in Working Paper 3b -- she just advertised this, she has not nailed them all -- are exaggerations that undercut the legitimacy and the believability of the case we want to make so here we are.

Worries about identity and individuality is not a problem because there will not be any identity and individuality. Mind you, Jim Wilson last time said, if I am not misremembering him, "The problem is not going to be that the kid is not, in fact, going to be somehow living out the life that preceded him but everybody is going to be looking at him and wondering why aren't you more like the guy I tried to plan you to be?"

So that the -- there still would be questions about identity and individuality precisely because you did not have the things identical. So that the attempt at a copy failed might produce consequences almost as bad, if not worse, as producing the copy itself should it succeed.

We have Paul McHugh from earlier, if I can find it, where manufacturing was point 1, copying was point 2, and then breaking off the kind of lineage and the human affection, which of course runs afoul of do we want to say something terrible about adoption and the fact that -- you know, et cetera, et cetera.

So I am with Michael Gazzaniga, I think we should just give up.

(Laughter.)

DR. MCHUGH: Can I just speak to that because I thought the conversation was going along quite well given what Charles had said. Charles was challenging the issue of if you think it is an infringement on human dignity to be a copy how do you deal with twins? And that seemed an important thing to do if you wanted to say that reproductive human cloning was a degradation of human dignity.

Now I think that the important thing to say about twins that occur in nature are that they are special in themselves. They are, themselves, individuals. They discover that they are twins rather that they are created -- they are manufactured as twins. It is part of their individual nature. In fact, to be a twin and not something that somebody said you are going to be a copy of anything other than somebody who is also living a life directly with you.

So, I think those are crucial distinctions between what is the natural creation of twins and their individual nature, which includes the fact that, gee, I am a twin, I have an interesting special life, and somebody saying, I am going to make you a twin of dad or even twin of Junior, who has already had a bit of a life and for which that copying is intended for my purposes and to some extent not completely for your purposes.

CHAIRMAN KASS: Unless someone wants to join in this, I had Robby and Mary Ann. Janet, do you want in here?

DR. ROWLEY: I can wait.

CHAIRMAN KASS: You can wait. Robby, Mary Ann and Janet, Bill.

PROF. GEORGE: Leon, I am not surprised that we are -- where we are because we come with a variety of different background ethical understandings and commitments so I think it is natural, if I can use that term, that we are where we are.

I think that some arguments will appear plausible to some people but less plausible or even implausible to others not because we disagree about some empirical facts or even predictions in some cases, although those would result in disagreements, but because of background understandings about what constitutes harm or what counts as injustice or wrong or what have you.

Now, I think that does highlight the fact that we are going to have to deal with a procedural issue if it has not been dealt with, Leon, down the line, which is should we look for a report, should we hope for or should we try for a report that will express a consensus or should we be satisfied to canvas arguments in a report that some members think are plausible but other members think are implausible and just lay the facts of the matter in that regard out in the report?

I do not know what we are planning to do or whether that is something we are to decide or it has been decided.

CHAIRMAN KASS: Nothing has been decided but let me make a proposal on this at least the way I have been thinking about it without actually articulating it, and this is to anticipate where we will be tomorrow where there will be nothing like this degree of rough agreement on the outcome where there might be differences here today about the reasoning.

I think we can proceed differently in the two parts of the discussion about cloning for biomedical research and cloning for baby making.

The last time there were some people who suspected that if you start to try to dissect the repugnance you are going to wind up with a bunch of arguments that do not add up to anything. Better Paul McHugh's 18-year-old revulsion at "The Birthmark" than anything that he has learned sense. Other people said, "No, we should make an effort."

If you look at the report of the California Council, the California body, they reached a unanimous agreement on the result and simply said, "Some of us find some of these arguments more persuasive than others." And I do not think that is simply taking a shotgun approach and hoping that everybody in there is going to find something that is their's. I think that was Charles' remark last year. There were 200 and some odd votes and seven arguments and there were 50 people or 30 people. My math is failing. You know, people found each of those arguments -- some people found each of those arguments persuasive enough to produce the conclusion.

I do not see any reason why we should not try to elaborate the variety of arguments that at least some people here think have weight. And if there are some about which all of us agree, so be it. If not, I think we can simply say, "These are the arguments that have been advanced, we do not all subscribe to all of them and these are there for your consideration. And, by the way, it happens that we think these are most worthy of your consideration."

That I think is a lot easier to do in this area than it will be when there is less agreement on the outcome unless one wants to say, as Michael Gazzaniga said very nicely wondering why we were spending so much time on it. Forgive me, I am paraphrasing it, "This is just disgusting, period." And I do not think -- forgive me but I do not think we can get away with doing that even if that is the first and, alas, the last word.

So, I do not think we should give up on this matter, though. I think someone has to step up and bell the cat. And if the language of human dignity is the language we want, it cannot be a slogan. I mean, it has got to be -- and we might, in fact, for the next time see if -- we are not the first to think of the term and it has a meaning other than Kant gave it, we are not bound to Kantians if we speak that language, but it might be important for us, just as we have had technical assistance on the scientific side, to get some discussion in here and maybe even someone in here if we do not have the talent in the room to try to develop some of these notions so that these arguments, in fact, can be developed in a more than sloganary way.

PROF. GEORGE: That certainly sounds sensible to me and I would support that approach.

I would point out, though, that there is a potential fallacy that we want to avoid running into and that is supposing that an argument's ability to attract widespread support tracks the strength of the argument or its fundamental nature. You could have an argument that is able to get us all -- that we will all buy, that we have got unanimity on, but there may be some people who think that there are stronger and more fundamental arguments but those very arguments are arguments that do not attract the support of some other people who buy the original argument.

CHAIRMAN KASS: Look, on this point, I mean, I will again make a proposal and I am open to your suggestions and corrections. It does seem to me that to the extent to which we have also a pedagogical and educational function, which means not that they should agree with us but that they should be given things to think about. It seems to me that the best argument might, in fact, be one made by only one person in here and we should nonetheless put it out there.

PROF. GEORGE: Okay.

CHAIRMAN KASS: I mean, I think that it is -- anything that -- anything that serious and thoughtful people in this room think is an argument sufficiently worthy -- we run it by everybody else to make sure there are not logical hollows (sic) or factual errors. I think it is important to at least provisionally say it belongs in the discussion and that -- because we are not finely sure -- we are not finely sure on which of these points the full weight -- we might not finally be sure which of these points the full weight falls.

If you are simply going to go what can command the most respect, Michael Gazzaniga said it, it is finished but I think that we are trying to do something -- I mean, the safety question is not finally an objection to cloning. The safety question is a temporizing objection to the technique and the question is would we have objections to cloning were it is safe? That is partly our charge and that means we have got -- you asked a procedural question. Did you want to --

PROF. GEORGE: No, I have a substantive point as well.

CHAIRMAN KASS: Let's do that.

PROF. GEORGE: But I wanted to get the procedural question on the table. It relates to the substantive point because the substantive point is to try to build a little bit on what Michael has been doing here this afternoon.

CHAIRMAN KASS: Let's do it.

PROF. GEORGE: And I -- the parallel is obviously not exact but in the debate over slavery, particularly the early debate, not the debate in the 1830s and '40s and leading up to the Civil War, but in the earlier period when slavery was introduced into the United States there were objections.

Among the arguments that were canvassed by the people who favored the importation of African slaves was the idea that the slaves themselves would be put in a better position than they would be in if they were simply left in Africa subject to tribal warfare and to enslavement in Africa and all sorts of terrible horrors.

And then the question became would it be better -- are we not doing them a favor and, therefore, doing them no injustice to import them into the United States however they are treated, and there was some, as you can imagine, idealization of how they would be treated in the United States, they will be overall better from a point of view of simply consequences the argument was. The situation is not one that you can really condemn on grounds of morality or justice because you are making people better off. That argument was countered not only by the objection that cast doubt on the likely consequences of importation of slaves for the slaves because some opponents of slavery were actually willing to concede the point and say that actually the slaves would be better off if you brought them here.

But they argued that by breaching the fundamental principle of human equality and introducing the institution of slavery in the United States, there actually was not even a United States in the early part, they were still colonies, you would be creating a cultural structure and set of understandings. An ethos, which would diminish everybody's self-understanding of their humanity or what Kant might call "their dignity." Or if we are going to be Kantians we will call "their dignity." You will make our own self-perceptions, the ethos that will be generated around the institution of slavery will just diminish our own understanding of our humanity.

And to fast forward, a lot of years later a friend of mine visited South Africa after the dismantling of Apartheid and came back and was telling some of us about it, and said, "Look, they are going to have a long time -- it is going to be a long time getting over the situation of Apartheid in South Africa because there was a kind of sickness. A kind of sickness that was introduced, a serious pathology that has affected people's self-understanding pretty much across the board that is just going to make it very difficult." An institution like Apartheid has long-lasting consequences. People say the same thing about the Soviet Union. It is sometimes put in terms of the terrible effects of communism on the Russian soul. People will talk in those terms.

But the point here is that sometimes it is not simply a concern that this or that individual human being will suffer these or that -- these are those bad consequences in the slavery case. We are now in the possible cloning case. But that we will create by virtue of introducing something that will be institutionalized where we will contribute to or exacerbate an already existing condition, which is one which is incompatible with a truly humanistic understanding. With an understanding of the human being as having intrinsic dignity.

Now, you put it earlier and put it in the last meeting, and I completely agree with it, that proper understanding of a child is not as an object, not something that can be or ought to be manufactured but rather as a gift. I think we need something like that in place to explain why children are not property.

It is actually quite difficult to explain on purely consequentialist terms why we do not treat children as property but I certainly think that we should make sure never to breach a principle, irrespective of what the immediate consequences would appear to be, to breach a principle that the breaching of which simply makes it impossible to say why children are not property or to treat children as truly gifts.

And that is why I think that the fundamental -- my own judgment of this is -- and here we are going to have different views about the plausibility of the argument. The fundamental problem with cloning for baby making is manufacture. It is treating the child as an object. It is breaching the principle that enables us to explain why it is that children are not property.

I fear that it is exacerbating an already bad situation because I think -- and I would be very curious about Jim Wilson's reaction to this -- I think we have already gone down the road much too far culturally towards seeing children not as having an intrinsic dignity but as having their worth in certain perfection that they are supposed to have in their ability to produce for us things that we desire as parents or as adult members of the society.

There is a mall near Princeton. I was wandering in the mall one day shopping and a woman with a couple of kids had one of the kids in hand who obviously had Down's Syndrome. And as the woman passed there were a couple who were on the other side of me and I heard one of them express to the other view that not only was this unfortunate that this child had Down's Syndrome but there was something irresponsible that the parents had done in allowing that child to be born. There was a wrong done. I am not sure whether they were meaning the wrongness to the child or to all of us or to the society who spent resources.

So there was no sense of the intrinsic dignity of the child that I could perceive in that kind of comment but rather Aylmer's error of supposing that the dignity of the child was dependent in some way on the child at least not having Down's Syndrome, if not being perfect, at least not having Down's Syndrome, and I think that is just emblematic of a problem we have.

Michael has pointed to some other factors that I think are indicia of that direction and my fundamental fear when it comes to the issue of cloning for baby making is that it will simply seal or at least exacerbate an already serious misunderstanding of the basis of the human dignity of the individual.

CHAIRMAN KASS: Mary Ann, Bill and Bill and Paul.

PROF. GLENDON: I would like to reflect just a bit on the kind of situation where you have wide agreement about an outcome but very different reasons for supporting that outcome. Reasons that maybe are different because of the philosophical presuppositions on which they rest or reasons that involve different estimates of probabilities and harms.

It seems to me that from the way this conversation has been going, we may end up in a place not too different from the rest of American society having a view -- a common view on an outcome and having quite a divergence of views on why.

Nevertheless, two things seem to me to be worth thinking about. One is that certainly a group like this can perform a great service by stating -- by evaluating the reasons that we think are nonstarters. Really trivial. And by giving our best views on the relative weight of the various considerations.

And then if we should come out with three, four, five reasons that are supported with different degrees of enthusiasm by different members of the group but none of which are laughed out of court by the group then I would suggest that the cumulative weight of those three, four, five, six reasons is itself a separate and additional reason for bolstering an outcome that is widely supported.

And a little historical example or precedent of this kind of thing: Right after World War II one of the first things the United Nations did was get a group of philosophers together to try to see if there could be such a thing as universal human rights. And these philosophers came from all different religious and philosophical traditions and, surprisingly, to their surprise and everyone else's, they could agree quite easily that things like torture and slavery were always and everywhere wrong but they could not for the life of them agree on the reasons, and they left it at that.

It is not a small thing to be able to say that some things are so bad in practice that no one wants to publicly advocate them and some things are so good in practice that no one wants to publicly disavow them. So I want to sound an optimistic note here.

CHAIRMAN KASS: Good.

Bill Hurlbut, Bill May and Janet. I think after Bill May if I did not miss the queue. Bill Hurlbut, Bill May, Janet.

DR. HURLBUT: I am not sure I can articulate this quite properly but I am going to try anyway. What you just said strikes me as really to the heart of the matter. As I was reading the papers we were given I remember in the Lederberg paper he talked about the possible benefit of cloning being an extension of what twins experience by way of intense communication and a deeper possibility of a richer fullness of social reality.

Now, I said a few minutes ago I do not personally think that would happen all the more because they would not have a common gestation. By the way, an interesting subset on what I said before is that twins actually share -- most identical twins share placenta. Some share other extraembryonic membranes so that they are consanguineous and even fraternal twins in the womb often share blood systems and sometimes express both their blood types.

So we are talking about a system where it is not just genetics. You are talking about a system where there is this profound intermingling of process. There is a scientific idea called "regression to the mean" and it is often taken -- this means that if you take tall parents, their kids will still end up shorter than you would have predicted probably. At least they will not compound and you cannot get -- necessarily get a really tall child by mating tall parents. You will probably get a taller child but what you are more likely to get is a child that is regressive towards the mean.

Well, why is that? Partly because of genetic reshuffling but, second, because there is this amazing -- the amazing process that homogenizes in the expression, the stochastic effects of genes playing out and so forth that what happens in one gestation is not necessarily going to happen in the next even with exactly the same genotype.

So that is the foundation of why I object to Joshua Lederberg first off but the second point is -- and this is why I said the thing about not copying -- our objection to cloning, as I agree with Michael, should not be that it will produce an exact copy. It should be, in the broadest sense, the type of intervention that is involved. The project that a person becomes.

And here I was thinking of Dworkin's paper. I am not -- I cannot really claim that I understood that paper fully but I think, if I understood, it I disagree with it. Okay.

(Laughter.)

DR. HURLBUT: And what I disagreed with it was this emphasis on the human obligation to forge forward into chance versus choice. I think the chance versus choice is a crucial issue here and I hate to introduce such a realm of personal belief into the equation but I think, finally, this comes down to some sense of how you do ethics and what that has to do with your sense of what the natural order really is.

And from my -- for my feeling, there is something good about the composite of the natural order. I -- Lednetz (?) has this idea of the "compossible" and here it means, the way I take it anyway, is that all things that are possible, even some things that are good, do not necessarily all coordinate into a better whole. So it is possible for us to do without, forego something that one could make a very good positive argument for, say in this case some benefit of cloning, on the argument that it destroys too much else even if it were okay and good in itself.

And here -- I know this is getting a little long but let me just try it anyway. I will be quiet after this.

Here I think we have to recognize that even medicine has a limited prerogative, not to mention the projects beyond healing. Even medicine at some point will say this is not what medicine is for even though one could argue it is good because when you put it all together there is a sense in which there are some things in human life that are made and they are designed apparently by nature for surface alteration, and some things that are just absolutely at the core of what makes us human, and if we disturb them they -- we either will lose our identity or we will lose our community. I am thinking here of alterations, cosmetic alterations of the face do not strike me as that big a deal morally, whereas cosmetic alterations of deep neurologic structures would, and there is sort of concentric circles here.

One last thing I want to introduce here is the idea that there is something in this general composition of the coordinated whole of nature that relates to suffering. Today is a very special day for the Christian community in that it is the Ash Wednesday, the beginning of Lent. I am right about that, right?

CHAIRMAN KASS: Yes.

DR. HURLBUT: There is a very mysterious combination in this perspective on life that combines a recognition of the disorder of the natural reality, disorder of what might be called struggle, suffering and sacrifice, combined with an affirmation of the fundamental goodness within what is considered a created order by the Christian, that there is something that binds these all together, these both together, which is very central to medicine and very central to every human life also, and that is this mysterious category called love, which is a meaningful combination of accepting some things as -- within the order of nature and working to change others.

And, I think, finally, in the end we are not going to define why one thing is -- something is wrong absolutely. Just that it simply does not work with what we perceive to be the larger and deeper human good, which is why I so greatly welcome this way of doing bioethics after having spent 30 years reading lowest common denominator pluralism.

CHAIRMAN KASS: Thank you.

Bill May and Janet?

PROF. MAY:: I would like to return to the points made by Michael and Mary Ann. I think it is very important to carry forward multiple arguments not reduced to common denominator. One may need to understand that the arguments are not related to one another like links in a chain, in which case you get somebody opposed to one assuming the whole thing is collapsed.

The metaphor behind your way of putting it together is strands in a rope rather than links in a chain. And one would want to eliminate things that are weak but one will also face the problem that one argument may cut against another as one prepares this. One cannot automatically assume one is putting together several strands that easily braid with one another.

My final point is that I just hope we are not too tactical about all this. There is a kind of apologetics and religious traditions where you have a settled conviction and then you just figure out how it will work with an audience and I do not think that is the way we ought to proceed.

I think, finally, there were complaints in religious politigetics (sic) that you ought to take God at least as seriously as you take your audience but in this case I think one also fails to honor one's heirs (sic). I mean, this is -- this has to achieve public discourse and it seems to me we are not here to manipulate American people but to engage in public discourse that sufficiently honors them, that we expose the deep reasons that shape and would allow us to articulate our convictions.

CHAIRMAN KASS: Thank you very much. I am now getting almost as lost as Gil for a slightly different reason. I would not dissent from anything that has been said but -- and maybe it is that we have been at this all day and people are tired but we are now getting more back into the metaconversation about what form this should take and how many arguments we should use, and gotten away from the substantive questions of which ones actually deserve to be trotted out there in the first place.

Now there was some resistance in the -- some suggestion that recasting these things in terms of harms as Working Paper 6 did it is shortchanging what we can do. That means one might be thrown back on Working Paper 3b, which, if it has any vices, erred in the other direction. I mean, it was expansion. It was speculative. It tried to raise large questions that ordinarily many of them do not get raised in these discussions.

And I would like to in the next ten minutes, before we take a break just before we get our own ethical instruction, to see if anybody wants to put their thumb on the scale here in favor of one or another of these moral arguments or the category of moral arguments. I do not want to say that they have not been put forth here. Several people have said, "It is the manufacture point."

By the way, "manufacture" to some people in the room already looks like being irresponsible because it sounds like taking a baby and building it up from nuts and bolts but it is, I think, the manufacture image in the literal sense of something made by hand, something made to order even if one is making only a small piece of it, the principle is somehow established. So some people have come down on that side. Other people have come down on the business of -- wanted to say, "Well, it is not just the manufacture alone but an attempt at a copy of a particular being that is important." Others that this seems to be a violation of the natural way of relating to children and the order.

But it seems we could -- the staff could use some help in trying -- I mean, you will provide some help by what you will write when you go home but today it would be nice if these last few minutes could be used for somebody to say, "Look, this is where I think the really important issue is in addition to the question of bodily harm."

Janet, and then Charles.

DR. ROWLEY: Well, I think many of us come back to some of the comments that Michael made and I am not the person to really thoughtfully articulate these issues but some of the notions of what we mean by either humanness or human dignity are, I think, some of the issues that can at least be raised in a more philosophical way and why are you concerned about manufacture? You are concerned because of the way it contravenes at least your notion of what human dignity is.

And so I certainly think that safety is a critical component for myself but I do think that there are some other issues that are dear -- probably more dear to many of you than possibly even myself but that would carry weight with the general population. These other aspects are really considered undesirable because they diminish either human dignity or some special qualities that individuals feel they have.

CHAIRMAN KASS: Thank you. Charles?

DR. KRAUTHAMMER: A couple of short points. One is you said -- you mentioned the word "speculative" in thinking of the harms. The harms are going to have to be speculative because we are not going to have empirical evidence if we succeed. There will not be any clones so we are going to have to speculate as to what it would be like to be a clone and why it would be bad and what society would look like. So I am speaking in defense of speculation because we are not going to have empirical evidence. We can draw analogies but there will be nothing empirical.

And so for the broad categories, let me suggest a shorthand. Harm to the clone, psychological and physical, and corruption of the rest of us. Hubris in the parents and the kind of chaos, if you like, in society, the rearrangement of the natural order in society. That may be three categories under which we could start to group the harms, the reasons.

And perhaps, as Janet indicated, maybe the central concept should be the assault on dignity, as Paul also suggested, as perhaps the central theme. Dignity -- it would allow us to be pioneers, as Michael suggested, but it also is grounded in an idea that is generally understood and respected and whose contours we could draw and explain what we mean colloquially by dignity in a more systematic way.

CHAIRMAN KASS: Mary Ann?

PROF. GLENDON: I have changed my thinking about some of these matters on the basis of the reading and I do not know whether there is any resonance for this thought but I started out thinking about this reproductive cloning as a very dramatic break with everything and I have come to see it more as a kind of continuum of a tendency that is already regrettably very well established in our society and that is treating children too often as objects.

So I think a way -- maybe a way of reflecting on this is that as surprising and shocking as the idea of cloning might seem intuitively, it really is very much of a piece and a kind of logical outcome of a whole lot of things that we have over time come to take for granted. An opportunity to rethink the way our society thinks about children.

CHAIRMAN KASS: That is very nice. Michael?

PROF. SANDEL: I agree. And that may make it worse than it appeared even when it seemed a radical break.

CHAIRMAN KASS: Gil?

PROF. MEILAENDER: Although, I do agree in some respects, Mary Ann, with what you said, I mean I think there is something different about cloning also that ought to come to the fore, and I am not sure. To me, when I try to think of the basic category, it has to do with what it does to the relation between the generations in several ways.

I mean, it is replication in a way that reproduction is not and that means that we are largely interested because we think we know what we are going to get. Granting all the truth about the fact that it is not an exact copy and so forth, it is just not clear that there would be such an overpowering reason to go ahead and do this if we did not think that we knew a good bit about what it was that we were going to get.

So that, in part, that replication means a certain kind of exercise at control. It does not mean that generations do not exercise -- one generation does not exercise control over a following one in other ways but this is a different kind of control and that seems to me to be important.

And the other way, and which still sort of under my general rubric of relation between the generations, comes to the product language that it -- we are -- if this were to be an accepted social practice, however, perhaps rarely done, at least for the time being, we are teaching ourselves to think about the relation between the generations in a different way as a product rather than a gift and there again -- I do not know if the language is controlled so much as -- or even dignity, which is always language that I have a hard time pouring meaning into, I think it raises questions about the human equality.

CHAIRMAN KASS: About?

PROF. MEILAENDER: Human equality.

CHAIRMAN KASS: Equality.

PROF. MEILAENDER: In terms of the relation between the generations. So, if I were going to try to sort of sort out what arguments seem to me crucial, I mean that has been very fast but I would do it sort of in that way.

CHAIRMAN KASS: Yes.

DR. __________: (Not at microphone.)

PROF. MEILAENDER: Well, it is -- I understand how it is that a child who results from the union of a man a woman might be thought to be a gift that they receive and one of them, equal to them. A child whom we produce through this act of replication is harder to think of in that way and insofar as it is harder there is a -- it is harder to think about them simply as equals in a way when it is made for that purpose.

CHAIRMAN KASS: Robby, and then I think we should take a break.

PROF. MEILAENDER: Just quickly, I want to reinforce what Gil says there. I mean, this makes a lot of sense to me. When we ask ourselves -- if we do take it as a given that there is something problematic about treating children as products, whatever our opinion is about whether cloning or IVF or anything else does that, but if we think that there is something problematic about treating children as products and if we think that the superior understanding that ought to be our's to the extent possible and our cultures to the extent possible is the idea of a child as a gift.

Getting behind that I think there is an ideal of equality that is doing the work. Why do we object to the idea of a child as a product? I think it is because we have an understanding that the producer is always superior to the product, that if we bring technique to bear to bring something into existence, that we, as the operators, as the controllers, as the people in charge of the technique are in a relationship of superiority.

Now we may vow and we may be perfectly -- make good on our vow. We may make good on our vow to treat the being brought into existence, whether it is a child or a cat or, you know, whatever it is, we are vowing to treat as our equal. And, as I say, we might make good on that but that -- even our making good on it would not negate the fact that in bringing that being into existence we did so on terms under which, in principle, we were the superior, they were the inferior, we were the producer, they were the product.

So I think that the staff would be well advised to look into -- to explore this idea that Gil has floated of equality being a fundamental issue at stake with respect to cloning and there is some literature.

In fact, I can recall, Gil, something of your's, if you can't, that addresses this issue.

And, I think, there is some additional literature that has been put out by the Lineker (?) Center for Health Care Ethics in London. If I recall correctly, a woman named Helen Watt has done some work on this but I will certainly help the staff with this.

And, Gil, if you know the literature, maybe you could as well.

CHAIRMAN KASS: Okay. Let us do the following: I will try, rather than now where my head is about as swimming as the rest of you, I will try between now and tomorrow morning, not to summarize this discussion or produce order out of it but come in with some assignments, generalized assignments of what I think we need to do to make the next step of this. There are things that have been said here that, I think, need to be developed and articulated.

I would like, I guess, Mary Ann, just to thank you for the suggestion. I mean, in my own thinking, I have tended, at least insofar as I have been thinking about Council business, to think about cloning in the context of other technologies and insufficiently thinking about it in relation to other child rearing practices and social arrangements, of which this would be a piece.

So it seems to me that if, in fact, we did not simply make this technically based but also a socially based assessment and developing the areas that could draw on other things, granted there is a lot of empirical research to be done to see whether our intuitions about those things are right but I think that would be a contribution.

I do think if we go that route it is incumbent upon us to try to distinguish between what is perfectly proper manipulation as some people call it, which -- I mean, what I call education, they call manipulation, and why it matters or does not matter so much, that it actually is the laying of hands on the genome rather than just going to work on their little souls from the time they are this big. I think there are differences but I think it behooves us if we are going to go that way to be able to indicate both the similarities and the differences I raised that last time. I do not think we have bitten that one yet.

Our public visitors should be free to go unless you want to hear how Council members are instructed about their own moral behavior. There are some snacks in the common room over there, which if you be quick about it, those of you who cannot wait to dinner, you go pick up something and come back in about seven minutes. We will try to keep the last session with our legal person for half an hour and I know some people have to go.

Thanks very much.

(Whereupon, at 4:53 p.m., the proceedings were adjourned.)




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