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Thursday, June 20, 2002


Session 2: Human Cloning II: Public Policy Options

CHAIRMAN KASS: Could we start to reassemble, please?

All right. This is the Council's, believe it or not, human cloning session 11, public policy options, the first of two sessions on public policy in which with no absolutely firm boundaries between them, we want first to have a general discussion of the strengths and weaknesses of available policy options, and then especially in the afternoon gradually move toward the policy recommendations that we might put forward.

I'd like to say a little bit by way of introduction to this because I think this is a difficult and vexing subject, but a very important one, and especially in the spirit of the conversation that we've just heard, one that is in some ways more important than the cloning issue itself.

It's very hard to tell when one is in the middle of a historical situation what it really means and whether it has the kind of signal importance that some of us think it does. One would like to think not that we have the authority over this matter, but one would like to think that one would try to think about this matter in such a way that 15 or 20 years down the road one doesn't look back and say, you know, we treated something as trivial which turned out to be massively important," or conversely, we turned out to treat something which was really quite trivial as if it was of world historical significance.

I mean, I have my own hunches about this. I don't know that they're shared, but I think it's at least important to be mindful of the question that this could be something very important.

Cloning, if it works, as we have already seen, would be a new mode of human procreation, and it might also serve as a kind of precedent for selecting in advance the genetic make-up of children. So it is something in itself and something that belongs to something larger than itself.

Cloning for biomedical research, if it works, is a powerful tool for understanding and treatment of human disease, but it also is an instance of the production of new embryonic life solely for use and necessary destruction.

And if it were legislatively provided for, this would not be just permitted as it now is, but it would be officially endorsed by U.S. law. So that is something to be reckoned with.

Also, this debate about cloning is a new instance of at least some tension in the longstanding, tacit, social contract between science and technology, society and politics, on the other. It is a social contract with a moral foundation, a foundation in which scientists and researchers are encouraged to pursue the truth, but in the service of the goods of the society that contract necessarily being stressed or tested, when the things that technology and science proposed to do or want to do might come in conflict, in fact, with the values or norms of the society.

And ordinarily we, at least in this country, have allowed these things to go along without too much attention. This now comes to be a test not just about the question of cloning, but how this community will, in fact, deal with those questions when we have goods in conflict, and whether there can be democratic self-governance about these matters or whether there should be or can be democratic self-governance about these matters.

So I want to suggest to you that although it looks like a small, little question, there are lots of things just in the penumbra of this that I think are quit important.

Second, I think we've all seen why this is so hard. We have in our previous meetings taken up the questions of the ethical issues of cloning to produce children and the ethical issues of cloning for biomedical research independently of one another, and that makes perfectly good sense because the moral issues that are raised there are, indeed, quite different.

And in fact, a sign that they're different is people can be opposed to the one and be in favor of the other, and people who might be opposed to both will differ as to which they think is worse.

It might, therefore, seem sensible to disaggregate these two forms or these two uses of cloning and develop independent public policies for each, and I think if anybody has thought about this a little while sees that it's virtually impossible. It's very difficult, if not impossible, to do so.

And the reason is simple. I'm just stating the obvious, but this is to at least make it clear why we are having such a hard time. The reason is simple because both of these activities of cloning begin in the same way with the initial act of cloning by somatic cell nuclear transfer that produces the cloned embryo, and therefore, it's difficult, perhaps impossible, to craft the policy that deals with one, but does not tacitly, and usually explicitly, affect the other.

A thoroughgoing attempt to prevent cloning to produce children by banning the first step would obviously prevent cloning for biomedical research. An attempt to promote cloning by biomedical research might well have consequences for cloning to produce children. An attempt to prevent cloning to produce children at the step of the transfer of a cloned embryo to initiate a pregnancy would tacitly approve the creation of the cloned embryos for research.

And imposing penalties on implantation while sanctioning creation, a policy that banned only transfer to the uterus, would then require that the cloned embryos be destroyed at risk of federal prosecution.

So these things are, alas, mixed up together, and as the conversation has already showed, even if one tried to craft policy through statutory language, the difficulty of doing this is enormous. Let's say you wanted to make a particular act illegal. You have to precisely define what act is proscribed.

And when I first started on this subject, I thought it very simple. It shall be unlawful to attempt to clone a human being. But it's simple to say and vexing to specify.

The question that is contested is: what do you mean by a human being? Does it mean a child or adult, or does it also mean the human embryo as a human being understood at that stage of development?

And the definition of cloning is, therefore, impossible to specify unless you've specified that in advance, and attempting to clone, if you want to say, "You shall not attempt to clone," that could either mean blocking somatic cell nuclear transfer itself or the transfer of the resulting cloned embryo to a woman..

Now, there would be a way of disentangling these two things or at least having them separate if, in fact, it was done as the British, in fact, did it or as some of the other nations have done it, namely, they have a general policy on embryo research which governs everything or they have a general policy on assisted reproduction and embryo research.

And then the cloning question fits in in some way. We don't have that, and that makes our situation here, I think, terribly difficult.

Just a couple of other things and then I think we can move to the discussion. It's perfectly clear from the conversations we've had, especially on the ethics of cloning for biomedical research, that we have a clash of competing goods and interests, and it's also clear from the discussion bearing on the question is this research necessary.

This notion of necessity came up in the previous discussion, and it is important to the moral analysis. There's a dispute even on that question because we do not have full knowledge about the science so that we proceed in this discussion as almost everybody does whenever they do public policy under the veil of ignorance, sometimes more, sometimes less, but always with the kind of uncertainty about the future.

What that means is when one moves from the discussion of ethics where one could sit in one's armchair and construct one's hypotheses to the realm of policy, one really has to move from the realm of principle to the realm of prudence, which is not to say uninformed by the moral analysis, but can't simply be settled by it.

And this means really thinking about the ends that we're seeking, thinking about selecting the fitting means always in the light of the circumstances, a very complicated task always, and especially when the best simply might be different from the best possible here and now. That might be the situation in which we find ourselves.

And I would at least like to suggest that the ethical analysis that we've been engaged in is certainly pertinent here, but it has now to consider all kinds of other things that are related to the complexity of what happens if you actually try to give voice to your ethical intuitions at the level of public policy, given the difficulties of drafting, given the competing goods and the like.

There is a question, I think, that will lurk beneath the surface of this discussion, which is who bears the burden of proof and persuasion in these kinds of matters. Is it the proponents who are proposing that we cross certain kinds of moral boundaries or is it the people who want to say no, when in a country, by and large, freedom is the rule? You have to do more than sort of say certain kinds of things might happen, but you have to show that they might likely happen and the costs to the common good are sufficiently great before you restrict people and even put them in jail.

I mean, these are important things, I think, to keep in mind.

Let me just introduce the specific proposals that we can consider. Then I would open the discussion either on the general matters and then gradually move to — I'll go wherever you'd like, but we have, if you think about it, one has, thinking now just about human cloning, and we've got, let's say, Cloning 1 and Cloning 2. I mean cloning to produce children and cloning for biomedical research.

There are two large categories, allow and forbid, and under each category, there are two possibilities: allow without regulation or allow with regulation; forbid for now, forbid permanently.

Anybody who likes matrices knows that you could make a four-by-four matrix, and you'd get 16 possibilities. If you did it for yourself, you'd see that there's a whole bunch of them that simply are not sensical, namely, that you would forbid cloning for biomedical research and endorse without regulation cloning for baby making.

So I think that the option that sort of survive as even things to be thought about are on a sheet that you should have in front of you. I'll simply read them off, and I think part of what we want to do is discuss the strengths and weaknesses of these.

One would be, in effect, the position that says allow with no regulation; no legislative action; professional self-regulation.

Second would be a ban on a cloning to produce children, but with no regulation, neither endorsement nor restriction of cloning for biomedical research, what we're calling ban plus silence on the research.

Very hard to do, by the way, to write that legislation so that it's simply silent, but never mind.

Possibility three, ban on cloning to produce children with regulation, permission but under regulation of the use of cloned human embryos for biomedical research. Option three called ban plus regulation.

Option four, regulation across the board, no restriction — no — in other words, permit but with regulation, something like the British agency where there's permission, but all permission must be given under the rules set by the Human Fertilisation and Embryological Authority.

Possibility five would be the most restrictive one: a ban on all human cloning, whether to produce children or for biomedical research. Shorthand: ban on both.

Then two proposals that consider the possibility of a temporary ban pending further information or additional public debate.

Option six, a ban on cloning to produce children with a moratorium, a moratorium being understood to be a temporary ban, a ban, but with a fixed time period on cloning for biomedical research. Option six, ban plus moratorium.

And option seven, a moratorium on all human cloning, whether to produce children or for biomedical research. Shorthand name, moratorium on both.

If somebody has something else, another plausible suggestion to add to this, this is enough, but if we've left something out, by all means, feel free. And since this is a general discussion and this is simply the fruit of the staff's analysis with my own input, we might not have done this right, but at least this is what we put before you for consideration both in general terms and with different options with their various strengths and weaknesses.

If there were a perfect solution for this, we wouldn't be sitting around here talking.

The floor is open. Frank.

PROF. FUKUYAMA: Well, not to complicate your matrix unduly, but I do think there is another option that would be my preferred option. That would actually be a combination of number six and number there. That is to say you have a ban plus a moratorium, but the explicit justification for the moratorium is that you need the time to put into place a regulatory, you know, apparatus as we've seen, you know, take six year or eight years even under favorable circumstances to do this.

And so, you know, the regulatory option is not a short-term option. So I would think that some, you know, combination of six and three is actually a logical —

CHAIRMAN KASS: You mean six for the sake of three.

PROF. FUKUYAMA: Yeah, right.

CHAIRMAN KASS: Janet?

DR. ROWLEY: Well, let me first just comment on Frank's last comment. I believe the six years is not due to the difficulty of putting in a regulatory apparatus, but rather just getting legislation through. So that I think it's important to separate the legislative process from the regulatory. At least that would be my interpretation.

And I have to say in reading the material that we were sent, I was concerned — that we were sent earlier — I was concerned on page 6 of the chapter we're currently considering that the burden of persuasion belongs to the proponents of human cloning.

And I have to say since it is something that is currently unregulated, though there certainly are prohibitions on the funding of aspects of cloning, that I wonder why the burden of persuasion is on the proponents rather than those who want to change the present situation.

CHAIRMAN KASS: Does someone want to join that?

Where —

DR. ROWLEY: Page 6, Line 18.

I mean, I think it's not our problem. Well, I think that the burden of proof is on those who say that what is — and I don't want to push this too far because there are certainly aspects that I would not be in favor of — but at least in the private sector, the laissez-faire attitude that is currently in place in the United States is a practice of at least those who can get private funding.

And it isn't only from companies because the Howard Hughes is also providing funding for some development of embryos for research; that the burden of proof ought to be on those who think that this practice should be stopped rather than on those who say that some component or some facets of the present situation — that we have to justify that component of the present situation.

And I would just turn it around and say I think the burden of proof is on those who say that components of the present situation should be banned.

CHAIRMAN KASS: Yeah. I really raised that as a general question in my opening remarks, and it really is part of how you come at this question.

I mean, basically we think in this country that you're free to do things until and unless there are powerful public reasons of a serious harm to a public good that keeps you from doing it.

DR. ROWLEY: That's right, but this document says that, in fact, the burden of proof was —

CHAIRMAN KASS: It was a question on moral persuasion as opposed to — if you follow the second point, I think you'd see it on that same page, but could we take up the question apart from the document? Because we really want to talk about the issues and not about text at this point.

And Janet, I think, has raised the right question. Gil, do you want to speak to that question?

PROF. MEILAENDER: Yeah, just a very brief comment to it. Although it's right, as you said, that we in our society have as a sort of general practice that we leave you free unless there seems to be good reason not to, I think it would be a mistake to suppose that there's been some kind of longstanding freedom to do research cloning, which now all of a sudden we need to think about whether there's justification to prohibit or regulate.

It hasn't, in fact, been done for very long or there haven't been good reasons, promising reasons to do it.

So it's not as if there's some sort of longstanding practice that opponents are suddenly thinking of stopping, and that makes a little bit of a difference.

CHAIRMAN KASS: Yeah, and the other thing that while it's not legislation, I mean, the various states can do as they wish, but I remind everybody that our predecessor body, the National Bioethics Advisory Commission didn't deal, I think, with cloning for biomedical research, but did in its embryo research paper make a distinction between — and this is not legislation — but made a distinction between the use of embryos left over in in vitro clinic and the creation of embryos solely for research.

Whatever the moral weight of the distinction is, and we've had some interesting discussions about whether that's a distinction that can be upheld, that has at least been the normative precedent of the climate.

Now, there are new developments that always challenge those things, and that's where we are, and Janet's question stands.

Michael, did you want to say something?

PROF. SANDEL: Just this briefly. The concept of burden of proof is a legal concept in convicting of criminals, and I think when we try to transport it into burden of moral argument, I think it doesn't help us.

Nobody who holds one or another position is going to say, "Well, the burden of argument is on me."

Everyone is going to say, "Well, no, it's on the other side." Well, if that's the case, let's just get to the arguments. I don't think anything is going to be helped by haggling over who has the burden of making a better argument.

CHAIRMAN KASS: Okay. After Rebecca speaks, I'll let you get to the argument, I mean, if you'd like.

I mean, if people want to weigh in on some of these general things, fine, but if that's where people would like to go, we should go there soon.

Rebecca, please.

PROF. DRESSER: Well, maybe I'm getting to the argument. I think implicit in that view — and, you know, there is a burden in civil proceedings as well that it would be based on this special respect position, that is, that a human embryo is not a piece of property or a person. It's something in between. It's owed some respect. So if we're going to create it, whether through cloning or some other procedure to be used in research, there should be extremely good reasons.

And that's where the burden of proof would be, to show that those reasons exist.

CHAIRMAN KASS: Does someone want to put their toe in the water and talk about the strengths and weaknesses of the various options before us or —Michael, please, and then Elizabeth.

DR. GAZZANIGA:: For those of you who are on the committee who are more familiar with policy, I think of it as sausage, but know all of the subtleties of —

CHAIRMAN KASS: The work for prudence statesman, Michael.

(Laughter.)

DR. GAZZANIGA:: Could someone discuss if there's a definitional reality to the difference between guidelines versus regulations in "governmentese"?

Because the current recombinant DNA model is really a set of guidelines, as I understand them, and not really a set of regulations, and I'm sure that's a determinological question we should get established here as to what we mean?

CHAIRMAN KASS: Someone want to take that? Rebecca, do you want to get in the — please.

DR. BLACKBURN: So my brief re-review of the recombinant DNA guidelines done on the Internet last night, I have to confess, was that it is applying to institutions that get any kind of NIH money, even though it's nothing to do with necessarily the project that is being considered.

And as far as I could tell, the force of it was the ability to get or not get NIH funding. And what the noncompliance consequences were, I am not familiar with, and maybe you can if somebody knows that.

It's meant to be a deterrent against violating those guidelines, but I don't know what forced the deterrence against violating, what form that took..

DR. ROWLEY: Well, I can answer that. You lost your NIH funding, and I believe you could not apply for new funding for a period of time, whether it was three years or five years, but for those dependent on NIH funding, it was a pretty serious consequence, though not criminal.

CHAIRMAN KASS: Well, I think we still need more on the general point, right? That is —

PROF. MEILAENDER: Well, what's at the bottom, I think most of us — I guess we're all sort of publicly split on the question of the ethics of biomedical cloning, half of us for it and so forth.

The recombinant DNA story had at the time a public fear associated with it that there was going to be something oozing out of laboratories that was going to transform the biological world. And in this particular context that we're being asked to think, there's no real biologic risk involved. The notion of regulation is for social concern for people's values and views. There's nothing at risk in terms of risk to the general culture in terms of health.

And so I think, therefore —

CHAIRMAN KASS: The women egg donors is certainly one of the issues that would —

DR. GAZZANIGA:: But that aside, I mean, the actual cloning procedure itself and so forth.

CHAIRMAN KASS: Right.

DR. GAZZANIGA:: So this is just why the question of regulation — we actually just mean regulation here in terms of almost satisfying social concerns and people's moral concerns and not because there's a biologic risk involved, too, as a result of the laboratory act itself.

CHAIRMAN KASS: I think that's largely right here, and as we heard in the previous presentations, I mean, among the things that are subject to regulation, I mean, guidelines might include things like the steps of licensure and what you have to do to remain in compliance where as regulations might include things that are just out of bounds or there might be regulation of commerce.

There is a regulation which says composated surrogacy is illegal. You know, uncompensated is permitted. Those are regulations, and if I understood at least the presentation of the Canadian system there, there are penalties that are attached to that

Alfonso and then Frank and Rebecca, I guess.

PROF. GÓMEZ-LOBO: Can I address that briefly? I think that when I think about reproductive cloning, I think the reason why regulation is needed and perhaps even something like a criminal statute is because, on the one hand, we know that certain actions can produce tremendous harm here to the women donating the eggs, to the woman doing through the pregnancy, and to the child himself or herself.

So it's not just because of any sort of vague social concerns. I mean, we're here talking about very central goods that hopefully our society will protect.

DR. GAZZANIGA:: I was thinking only about the biomedical cloning obviously, not the reproductive cloning.

CHAIRMAN KASS: Okay. I have Frank, Rebecca, Janet — no. Your name is on the list, and I don't know whether it was for the last time. Okay. Thank you.

Frank, and then Rebecca.

PROF. FUKUYAMA: Okay. So is it —

CHAIRMAN KASS: And then Robby.

PROF. FUKUYAMA: — appropriate to jump back into the substantive?

CHAIRMAN KASS: The floor is yours, sir.

PROF. FUKUYAMA: Well, I guess what I'd like to do is just lay out my position of how I proceed from my basic ethical position to the actual public policy because, as I just said, I'm in favor of six leading to three, and I would do it for the following reasons.

I put myself in the camp of special moral status, that is to say I do not believe that an embryo has the same moral status as an infant. I believe moral status rises. I mean, I'll just — in addition to the text that we were given, I thought it gave a fairly good defense of that position.

I would just add a couple of examples because I know Alfonso contested the idea that you could have a coherent doctrine of rising moral status.

But I think that, you know, in fact, we attribute that to human beings all the time. For example, children have a different moral status than adults. Children are not given political rights. They can't vote because they don't have full human reason, and you know, political rights are, you know — it's not the right to life, but it is an important component of, you know, the class of individuals to whom we attribute.

Now, I would just like to say I don't want to start a big argument over this. I'm just trying to state my position.

DR. MCHUGH: Oh, why don't you open that door?

(Laughter.)

CHAIRMAN KASS: The record notes that that's not a universal opinion in this room.

PROF. FUKUYAMA: And, you know, I know we could argue for the rest of this session over that. I'm just telling you what my view is.

However, I believe that, you know, there is some moral status that is, you know — that differentiates an embryo from just another clump of cells, and I will give you another analogy for another group of — a case similar to this, which is bodies of dead people.

We attribute a special moral status to those. If your Uncle Eddie dies in your living room, you can't just dump the body into a dumpster. You have to take a lot of — it's a highly regulated, you know, set of actions that happens when somebody dies because we believe that even though this was not a moral agent, you know, that that deceased corpse is, you know, due a certain amount of respect that is different from other kinds of tissues or different from a dead animal body, and so forth.

And it can be used for experimental purposes, you know, medical schools and so forth. And so we regulate it very carefully.

Now, my particular fear is about research cloning, not with the procedure itself, I would have to say, but more with precedence and slippery slopes and other things that may proceed if we simply permit it in a completely unregulated way.

Again, a lot of this was articulated in the report, but for example, I would not want in three or four years' time for the medical research community to come back and say, "Yes, in fact, we do need to get not just stem cells out of embryos. We need to get entire organs or fetal eggs or tissues out of fetuses. And, by the way, we should be able to do that because, you know, what's the difference? We already extract stem cells from embryos. So why not go about this?"

And the same arguments will be trotted out that we're going to save X number of lives, cure X number of diseases if only we can do that.

And I believe that, you know, there is an important role difference between an embryo and a fetus, and I definitely would not like to see the latter thing happen, and I don't want the precedent of research cloning on embryos to be used as a precedent for allowing other things further down the line, human animal hybrids.

You know, I mean, there are a lot of things that are bad in the other legislation in Canada and the U.K. that are example so categories of things that are not issues right now, but where we could get to based on precedents that we set in our policy towards research cloning.

Therefore, I believe that the appropriate solution is to permit it under a strict set of guidelines that would involve no research past, you know, 14 days. I mean some — you've got to pick some fairly arbitrary number, and you know, I think actually the outlines of the kinds of regulations; we could argue about this or that specific provision, but a lot of those have been laid out in the legislation that exists in other countries.

And I think that under those circumstances most of my, in a way, prudential fears about permitting this kind f research to go ahead would be satisfied.

And that's why I think that, in fact, the optimal solution from my standpoint would be the regulatory option rather than the complete ban.

Now, again, I'm hoping to short circuit a big argument over moral status because I just don't think we're ever going to convince each other. I would just say, you know, to those that want the complete ban that it looks like, given the realities of politics in the senate right now, that we're simply not going to have option five, the ban on both. Okay?

So then the position defaults to option one, which is essentially no ban on anything, and I guess what I would just ask you to do is to consider seriously, you know, in the real world of politics whether no ban on anything is better than, you know, my proposed solution, which would be a ban on the things that we can agree on banning, which is reproductive cloning, and then a moratorium leading to a series of rules that would satisfy, you know, I think a lot of the precedential and desensitization kinds of issues that I think are very real ones in permitting research cloning to go ahead.

CHAIRMAN KASS: Could I make a procedural suggestion? We've tried and, I think, pretty much succeeded even as this debate swirls around us to keep an eye on it, but to have our own discussions here, and it's true that when one makes prudential recommendations, one would be foolish not to notice what's going on around us, but at least at the first pass I think we should talk about what we think would be best were it up to us.

And one could then make some adjustments. Frank's point is well taken, but I would rather we not immediately sort of start guessing what might work, what might work in the Senate if they were to listen to us. They're unlikely to in any case. We should try to figure out — we should try to recommend what we think is the right thing to do.

Let's see. I've got a queue, and I hope everybody will get into it. Let's see. I've got Rebecca, Robby, Michael, Elizabeth, Mary Ann.

PROF. DRESSER: I agree with Frank that there are a lot of similarities between three and six, ban plus moratorium and ban plus regulation. I think three is really a de facto moratorium, and of course, the difference is that it would be de facto moratorium getting the planning going, the system going.

And in connection with three, I wonder if when we say "regulation," that there are a number of principles, I think, as we've heard, and certainly I can think of a number of other principles that a regulatory system could have in place if, you know, it were regulating biomedical research cloning.

So I wonder if it would be worthwhile discussing more substance and procedures. I think we had an interesting discussion this morning about who should participate in this regulatory body. I personally very much am in favor of a large component of people who are not from a scientific or medical background being involved in making judgments about when a proposal to clone research embryos might be justified.

And I would also want to include not just — even though this is against my self-interest, I suppose, it seems so often when people say there should be public members, lawyers end up being the public members, and it sounds as though in the U.K. that's frequently true.

I do think that there is an important place for ordinary people. I think that this problem of trying to get people who do not represent one interest group, but yet are thoughtful, involved, and interested in moral questions and not just ciphers is a challenging one, but I really think it's one worth pursuing.

So perhaps we might talk about if there were to be a regulatory structure how it would work and what specific principles different people might favor.

And then I just thought I'd throw this out. This is probably off the wall, but I thought of it this morning. One concern I know that some people have with biomedical research cloning is that it would, if it were permitted, it would put the government in the position of requiring the destruction of human embryos.

And I wondered if anyone would feel any differently if there were a no freezing rule or a no preservation rule in research so that in some respects you could say the embryos are allowed to die rather than actively destroyed.

And then, on the other hand, what kind of a scientific impact would that have I you weren't able to freeze the embryos in research?

I thought of that on the exercise bike this morning, and I thought I'd throw it out.

CHAIRMAN KASS: Michael Sandel.

PROF. SANDEL: Well, though I share much of the spirit and even much of the substance of Frank's position, I have just a small qualification that I would add and suggest, and perhaps he wouldn't object to this first.

I don't think, as someone who holds a position close to the one on the substance that Frank has articulated, I don't think that we should urge colleagues or fellow citizens who hold the equal moral status view to support a moratorium instead of a ban for the following reason.

A moratorium, as Leon pointed out, might be justified if you say that you need further information about the science or about whether the science is really necessary.

But if you hold the view that ethically, regardless of the benefits, ethically it's wrong, it's like killing a baby for a good end; it's wrong to extract stem cells and to destroy the embryo; then a moratorium which says, well, we need more information doesn't really capture that position.

A moratorium, after all, presupposes that the practice is not ethically impermissible, but we need to really find out about the science if it's necessary. Will the therapies work? Are there other ways of doing it scientifically?

But to accept a moratorium rather than a ban presupposes that maybe some time down the road this would be morally permissible, and otherwise, the principal position is a ban.

So I don't think that we should say, "Look. Your view isn't going to prevail in the Senate," and who knows whether that's true or not. Even if it were true, I don't think we should be in the position of trying to persuade colleagues who hold the equal moral status view in good conscience to say, "Don't support a ban. Support a moratorium," because the moratorium doesn't capture that moral position.

It sends to the public and to ourselves and to the President a different message. It says this is not fundamentally wrong for all time. That's why we want to have an open mind. That's why we want to see how the science unfolds.

Having said that, I would just want to pick up on a point that Rebecca just made for the view that those who don't hold the equal moral status view, but who hold some — but who would still accord respect to the embryo, I think Rebecca had a slightly different way of addressing Frank's concern.

Position three Rebecca just said, and I was struck by this, is a de facto moratorium because position three says it's not morally impermissible for all time, but we don't want commodification; we don't want exploitation. We want to establish a limit, whether it's 14 days or others. We want to license and conduct prior review of all research involving cloned embryos.

Well, if the regulations even in general terms are specified along those lines, then position three, ban plus regulation, could say under the regulatory half of it that only instances of cloning for biomedical research shall be permitted that observe these various restrictions, no buying and selling, no modification, and so on, and that are licensed by some authority or border commission yet to be established.

And if you established, Frank, as one of the regulations the licensing requirement, then by definition it couldn't go forward until that board or that authority were in place.

So that's why I think your concerns, which I share, could be perfectly well met within the compass of number three, drawing upon Rebecca's suggestion and listing among the regulations the licensing requirement, which wouldn't exist, and therefore, the permission couldn't be given until that board and those regulations were already established and existing.

CHAIRMAN KASS: Elizabeth.

DR. BLACKBURN: I'd like to continue to draw on this question of the moratorium, de facto or otherwise, and in thinking about a moratorium as had been proposed in number six, but I'm certainly listening to what's being said about number three with respect to it being de facto moratorium — I see a lot of force in that — I just do want to raise some points about a moratorium.

It sounds tempting to have a moratorium to get more information, but I really am trying to think hard what is the information that one is going to get if the very kind of information we want to get about promise of the possible benefits of the research is not going to be allowed to take place?

So then the question is: well, could you get that information from other kinds of research?

So I thought hard about this. Can you get that? And I really think you can't get that kind of information, and let me just give you a few examples of it.

Say, for example, with current, let's say, excess in vitro fertilization embryos, what you would get would be some set of embryos, but the kind of information you'd need about them, the ability to have disease models, the ability to have certain genetic diversity that you knew something about at least, you just wouldn't have that. And so you would really hobble the information you would get out.

And then, secondly, if one were thinking about somatic cell nuclear transfer derived embryos, what can they give you besides excess in vitro fertilized embryos?

And I thought very hard, well, you know, what do they give you and is it substantive, and again, I think it is substantive, first, for those reasons I just said, and secondly, that you can do things in terms of finding out some of the key issues about the therapeutic value of cloning for biomedical research derived embryos.

For example, what would be the immune rejection issue? There are a lot of really good in vitro type of examinations one could do to get at this question that you couldn't do otherwise with animal systems, for example, and animal models have been the only source of information on this topic to date, and we know that animal models are not valid models in a lot of biological questions that we have about humans.

And I can, you know, cite various disease sorts of cases and things that are relevant for cancer in the mouse versus the human. They are very different. They play out differently.

So I do want to say that the problem then is that if one said, "Well, let's have a moratorium and wait for more information that will give us a better informed set of facts on which we could move ahead," we won't get those facts unless the information can be got from the somatic cell nuclear derived embryos.

I just can't see how the information — so then there's a real inconsistency because, you know, some members of the Council, you know, have concerns about the ethical problems with cloning for biomedical research based on embryo status, but it seems like from our deliberations, you know, probably a good half of us don't have ethical problems with this.

And so we all have said this is important enough to move ahead with, and so then if it's important enough to move ahead with, then we don't want to just hobble the ability to do it properly.

So my feeling is the moratorium then was a real concern to me because it seemed to me actually counterproductive to what we are thinking of as the possible good that would come out of this. And so I think back then to what I think Rebecca said, which is sort of returning to the point of in effect, if one does have appropriate licensing for regulation — licensing which would include, you know — be included in the regulation, then in a way that does take care of it.

I think imposing a moratorium per se does not achieve anything, and I think it's actually counterproductive for what we feel might be the good coming out of the proceeding forward.

CHAIRMAN KASS: Elizabeth, could I ask you just directly on the science?

DR. BLACKBURN: Yes.

CHAIRMAN KASS: Granted that eventually if this is to be shown to be useful in human beings, it could only be done by experimentation with human beings, but —

DR. BLACKBURN: Oh, Leon, before that, there's much in vitro work that could be done before —

CHAIRMAN KASS: I'm not talking about therapy. I'm talking about —

DR. BLACKBURN: Okay. Sorry.

CHAIRMAN KASS: — I'm talking about —

DR. BLACKBURN: You mean only on cloned embryos.

CHAIRMAN KASS: Yes. I'm sorry.

DR. BLACKBURN: Stem cells derived from cloned embryos, yes.

CHAIRMAN KASS: Ordinary stem cells are not in the discussion here. I mean stem cells derived from in vitro — adult and embryonic stem cells derived from sexually fertilized embryos are not part of this discussion. Just on the question of work with embryos produced by somatic cell nuclear transfer.

DR. BLACKBURN: Right, right.

CHAIRMAN KASS: Right. For the most part, we've had proposals about how this work could be useful both in terms of deriving basic knowledge and possibly therapeutic benefit. I think it's fair to say that there's very little evidence available to us now in the science as to whether that promise will be realized or not.

Would it not be relevant to see whether some of that work could be done in animals to the point of actually encouraging us to believe that the human work would work?

And wouldn't it — second point, there's a claim that there is a unique benefit to be had from working with cloned human embryos and tissues derived therefrom, but since part of the question has to do with the necessity and whether there are other morally nonproblematic alternatives be taken up before certain boundaries are crossed, what if it should turn out that the work that we heard about last time from Dr. Verfaillie, which by the way I think is about to be published today or tomorrow in Nature?

One would get the variety of stem cells from the whole plethora of disease models. One would be able to study the differentiation. Wouldn't there be some burden before one sort of crosses this line to actually say — we really have some evidence to say not only that this stuff will work and will be promising. We've done work in animals, but also that we don't have other morally nonproblematic alternatives.

Is that part of the way we think about the necessity of doing this as opposed to it's interesting, very useful?

DR. BLACKBURN: I think of course alternative methods and all avenues, I think, are important to explore in getting the kind of basic understanding which will then be very important for getting usefully therapeutic information, you know, be it of the tissue generative type or other kinds of broader information.

So let me take your points perhaps in reverse order. The question of what will adult stem cells and their reported plasticity give us, we won't know that from the publication tomorrow.

CHAIRMAN KASS: No, that's for sure.

DR. BLACKBURN: It's very controversial, and there are many different interpretations out there in the field.

I just recently attended a workshop on this to get myself well informed on this. We're not going to know about adult stem cells being the one and only way to do this, and Catherine herself has certainly —

CHAIRMAN KASS: I didn't say one and only, I think.

DR. BLACKBURN: No, no. And she herself pointed out the value of keeping the avenues open because we don't know which will be best. So certainly adult stem cell research, I think everyone agrees, should certainly be pursued vigorously for what it could be useful for, but it's not going to be the only thing, and it will not answer for us whether it's the only possible source of —

CHAIRMAN KASS: But let me —

DR. BLACKBURN: — the information we can get out.

CHAIRMAN KASS: But let me persist on this because the question — on the issue of the moratorium, I mean, one of the arguments for a moratorium would be right now we have mostly — and I'll exaggerate — right now we have mostly promise and virtually no evidence.

DR. BLACKBURN: Well, except in animal models.

CHAIRMAN KASS: With respect to the cloning, with respect to the cloning.

A moratorium would, in fact, perhaps answer this question about the unique value of this. It might or it might not, but it's not — that is at least — if the question is — sorry. Let me put this — and, by the way, I'm not plumping for a particular outcome.

I think just as the side that says you shouldn't go forward because there might be harms has to do more than speculate about the harms, but show that they're likely and that they're serious, so it seems to me that the side that says there has to be benefits has to do more than wave the flag.

And also if you're crossing a moral boundary, then it seems to me something of the burden of the uniqueness or the necessity of this. And if we don't have the evidence of the necessity, that it seems to me is also part of the moral deliberation.

It doesn't settle the matter. There are some people who say this research should never be done, but I'm basically asking the scientists in the group to not simply say, "Well, we won't know." But does it count? And could we find out?

At the moment we don't have the animal research, and we haven't really tried the other alternative. What would be so terrible about saying take four or five years and find out what the alternative is?

That would be my question.

DR. BLACKBURN: Well, I think that you would be so hobbling the investigation as to make it — you see, you're saying let's use apples to learn about oranges, and that's the issue, oranges being the cloned somatic cell nuclear transfer derived organisms.. Because they really can provide a very different set of stem cells in which you can do experiments that you wouldn't be able to do with the in vitro fertilized excess embryo route, for example, because of the kinds of disease models and genetic variability you can get.

You really cannot get that from what we have in hand. The second issue then is animal models. Of course, you know, everyone wants to use as much as possible the animal models, and there's no doubt that they have provided some evidence as we heard from John Gearhart, that there's some interesting and very interesting, you know, provocative and I'd say promising — I know you're devaluing the word "promising" — but promising therapeutic proof of principle demonstrations that have gone on in animal models.

CHAIRMAN KASS: They were rejected in that animal.

DR. BLACKBURN: Sorry. What was rejected?

CHAIRMAN KASS: I'm sorry. Let me just desist. Sorry.

DR. BLACKBURN: So this is not in any way to say that animal modeled research is not valuable, but in the end it doesn't tell us about certain things about human diseases.

Just take my own field, if you want me to get very substantial. The role of telomese (phonetic) and telomerase in development of cancer in a mouse plays a very different course out than it plays in humans. We do not learn the same things, even though the list of actors is the same.

The thing that they play out is really different, and in the mouse it didn't tell you what was important in the human.

So it's just one very tiny example. So I think scientifically we just won't learn what we would learn if — when I say "we," I mean the community is large. I don't do this research — but one wouldn't learn the same kinds of things.

So that's why I'm thinking the moratorium imposed per se actually — you know, it actually prevents the very purpose that it's supposedly to produce.

CHAIRMAN KASS: Janet, to this?

DR. ROWLEY: I'd like to make several points, one of which is for most of the biomedical community that depends on NIH for support, there is already a moratorium, and there has been a moratorium for years on funding any sort of research on embryos, embryonic stem cells, et cetera.

So that is the present situation. If you go to private organizations or you go to companies, it's different, but for the vast majority of scientists, we are already in a time of moratorium.

Just as an aside, I haven't seen Catherine's paper in Nature, but at least up until a couple of months ago, her adult stem cells ironically derived from bone marrow could not produce hematopoietic stem cells.

So they can be transformed into everything else, except hematopoietic stem cells, and this just shows a limitation of that particular system.

And the more substantive point is that as I would envision a regulatory body, and again, one that we all hope will be constituted of the very thoughtful individuals, the proposed research on embryos would come before such a body for scientific, as well as ethical review.

The scientific review should be very — should look very carefully at what is the proposal from the particular investigator. What is the unique role that that research plays? And why is the use of somatic cell nuclear transfer into oocytes derived from volunteers or whatever source? Why is that the only way to do this research?

So I think in a thoughtful pattern of regulation you would already have answered the questions that you're raising.

And I agree with Elizabeth. We are already in a moratorium. Extending the moratorium only impedes scientists who would like to get at transferring or transforming a promise into some reality at least in certain circumstances.

So that I think that the thoughtful development of a regulatory body is really a critical aspect of this. I was taken by the comments that Lori made in her presentation to us about the U.K. That legislation, as I understand, and I may be misquoting you and you can speak for yourself obviously and educate me and others, is for the most part relatively general, though obviously the newest one preventing or banning reproductive cloning is fairly specific, but the legislation is fairly general, and it is, I gather, assumed that this regulatory body will be the one that will over time review the situation, modify the regulations based on an evolving set of knowledge and make regulations at the time that are appropriate for that evolving set of knowledge.

And the other thing you said was that there are working groups of five individuals, I believe, and much of these or at least some of the specific details go to those working groups for their evaluation as long as they're not policy issues maybe before they go to the larger group of individuals.

And I would envision, as well, that in institutions that already have institutional review boards for looking at matters that deal with human tissue, any research that I do in my laboratory on patient material is already reviewed and approved by our institutional review board before it goes to anyone for any consideration or funding.

I think with all of those levels of review and consideration that one of the important issues here is more how to develop a regulatory body, and I don't think that we need to consider a moratorium as one of the options.

Did I misspeak?

MS. KNOWLES: The only thing that I would correct is that it's actually not the authority that makes the regulations. The regulations are made through the parliamentary process, regulations to the act. So adding more to the act through regulations is quite a cumbersome and official process.

But they framed the act generally so that the licensing body, the HFEA, has significant discretion in its licensing functions so that they go through a number of steps and really get a lot of information,a nd that's where the discretion is.

CHAIRMAN KASS: I have Mary Ann next.

PROF. GLENDON: So far in this discussion only two reasons have been mentioned as justifications for the moratorium. One is the time necessary to prepare regulations, which as Rebecca pointed out imposes a de facto moratorium, and the other is time for research, which has given rise to a certain debate.

But there are at least two other reasons. One is the reason that was mentioned by Dr. Kass from the very first day when he spoke about the purpose of this commission, and that is to raise the level of the national conversation.

And I would think that those who favor a moratorium for purposes of preparing regulation would also include among their reasons the idea of having a broader public debate, the kind of deliberation that we expect in a democratic society and that we haven't really had yet in the United States about these complicated issues.

So, Frank, these remarks are really addressed to you. It seems to me that what you are proposing is not a hybrid of three and six, but rather something that fits quite comfortably under six, that is ban plus moratorium.

And the reasons for the moratorium would include in your case probably preparation of regulations and public deliberation, maybe time for more research or maybe not, and there are many of us who might have a combination of all of those reasons or various combinations of those reasons.

So that I just ask you to think about whether you really need to have a whole new category or whether you'd be comfortable with the sixth one.

PROF. SANDEL: Could I just address a quick question to Mary Ann?

Would those be reasons for you to prefer moratorium to a ban on both?

PROF. GLENDON: I'm comfortable with alternative number six.

PROF. SANDEL: But how would you answer the question whether they would be reasons on balance to prefer the moratorium to a ban?

PROF. GLENDON: Well, I'm going to sound like a law professor now, but I don't think that — I think one can exaggerate the difference between moratorium and ban.

One of the glories of legislation is — and here I have to quibble a little bit with something that Leon said. You described the ban as forbidding permanently.

CHAIRMAN KASS: Yeah, that's always reasonable.

PROF. GLENDON: Legislation can always be revisited, unlike court decisions on constitutional grounds, which are much more difficult to revisit. So I don't see the distinction between ban and moratorium as crucial.

CHAIRMAN KASS: Bill May and then Gil.

Did you want just a quick word? Sorry.

PROF. FUKUYAMA: It's funny that you're pushing now back to six because I was actually persuaded by Rebecca and Michael on three interpreted, you know, as a de facto moratorium just for the following reason.

If you had to delay research cloning until you got a regulatory system in place and made that link explicit, it would give a real incentive to put that system — you know, to get that thing up and running. Whereas if you simply had a moratorium with, you know, a general idea that you wanted a regulatory system at the end of the moratorium, you could easily imagine the moratorium expiring, everything going back to everything is permitted, and the regulatory system, because of all of the problems in getting all of the interest groups lined up, you know, and so forth simply not materializing.

So I actually — again, I hate to fall back into these tactical considerations, but I actually am sort of persuaded that three interpreted as a de facto moratorium may actually be preferable to my earlier combination of three and six or your, you know, interpretation of six.

CHAIRMAN KASS: I've got a queue. Bill May and then Gil.

DR. MAY: The earlier discussion of the intermediate status of the embryo, it seems to me, has a double implication, and most of the emphasis if followed is that it allows for research as opposed to those who think of it as having full participant status.

But the other side of that is that it necessitates regulation, and we shouldn't lose either side of the implications. It's the moral implications of that status, it seems to me, those who hold to that position.

And I will repeat what I said earlier. It seems to me that the implications of that status raise issues not simply about time limit 14 days, informed consent and so forth, but powerful restraints upon commercialization, both in the production of knowledge and therapies, which is what I think Rebecca has emphasized, but also in the distribution of knowledge and therapies, the access to it.

And that broadens out the whole question of the health care system in this country, and I know we can't take that on, but it seems to me when you state regulations, you have to point to that. How one makes that operational is a very difficult question, but it seems to me it cannot be ignored in any final statement about regulations.

I don't think I can carry any farther than the conversation exchange between Elizabeth and Leon, but I want to bring into the discussion something that Michael wrote in one of his memos.

The argument that we may too easily assume that there are alternative modes of research because there's a difference between left over embryo research and cloning for biomedical research, and as I recall in your New York Times op.ed. article you pointed out that morally really they stand together.

And if that's the case, if research on leftover embryos is not essentially different from cloning for medical research, they stand together or they fall together was, I think, the point that you made in your statement. Hence, either forbid them both or do both.

And if you don't say forbid them both, then maybe you will get faster to the answers to the question of possibility and necessity that Elizabeth is talking about, if you see that at least those two forms of research really stand closer together morally than has been previously assumed by a lot of us.

CHAIRMAN KASS: Gil.

PROF. MEILAENDER: I want to try my hand at reinforcing the point that Mary Ann made because I think it's important.

I preface that by saying, I mean, in my own ideal world, we would ban research cloning simply because we would ban cloning. I mean, there's a sense in which I haven't been happy from the start with the distinction.

You will remember we had the terminological wars for a while, and we've kind of arrived at a way of talking about it that I'm happy to acquiesce in so that we can talk about it even though it actually distorts to some extent my own view of the matter, but I mean, we have to talk, after all.

I'd be happy to have this Council make no policy recommendation. I don't actually think it's all that important, to be honest, as compared with the fleshing out of the arguments and the explaining of the rationale in both moral and policy terms. That would please me all right, too, although I'm probably a distinct minority on that point.

But, I mean, there is something to be said for the moratorium language, and I thought, Frank, you needed to take a little more seriously Mary Ann's point, that is to say, one way — and, Michael, it comes to your point about kind of respecting alternative views. One way of doing that is that it's conceivable that several people could come together agreeing on such a recommendation over quite different reasons, and you wouldn't necessarily be endorsing everybody else's reasons in doing that.

If I were to support a moratorium, it would be precisely so that the moral argument can continue. I mean, I wouldn't really support it so that we can get regulations in place, since it is, after all, not an activity that I want to proceed with regulation, but you know, I could have my own independent reason.

Somebody else might share several reasons, but I mean, that is a way of trying to take seriously the concerns and the moral positions of several different people without setting aside one's own.

I mean, what Mary Ann has pointed to is an independent kind of reason why it's at least a possible policy option in my mind, even if, I suppose, in the best of all possible worlds not the best option as far as I'm concerned.

CHAIRMAN KASS: Okay.

PROF. FUKUYAMA: No, I do take very seriously, you know, Mary Ann's, you know, urge that we need to have this moral debate, but I can think of no better way of stimulating that than actually having on the table, you know, concrete legislation for regulating this area. I mean, that's what drives the editorial writers and, you know, the think tanks, you know, to actually talk about some of these issues.

Whereas simply a moratorium that doesn't actually — isn't connected to a concrete, you know, public policy I think risks just sort of continuing. I mean, debate will continue, but I really — you know, for example, the stem cell debate that we had in 2001 was driven by the fact that there was a timetable for the administration to announce a new stem cell policy, and that's really what I think got everybody interested in learning about stem cells and, you know, editorializing and so forth.

And so I do think, you know, that three would achieve a lot of that purpose of stimulating, you know, the public discussion about where we're heading.

CHAIRMAN KASS: Who do I have next? I have Dan Foster.

DR. FOSTER: My recollection of the last meeting, and I just want to make one point about the options of adult stem cells that I know that seem favorable to many people, that at the end of the conversation, the discussion — I haven't gone back to look at the transcript, but I believe that when — and I haven't seen the Nature paper that's supposed to come out, but I believe that in her discussions she also made the point that her own laboratory was proceeding in terms of embryonic stem cell research because of the fact that there needed to be comparisons between here, and the she herself was not at all sure that the adult cells were going to do.

So, I mean, one needs to remember that the leading proponent of adult stem cell herself has said we need to advance in terms of these other issues.

And unless my recollection is wrong, I think that she did say that, and I believe that Gearhart also made the point that both issues need to look — and they may act differently. You certainly can't — I don't think you can compare without comparison. The same thing, if you look at zygotic embryos from leftover blastocysts, I mean, I have considerable concern about the rejected blastocyst, about the long-term storage in terms of freezing, in terms of deterioration and mutation and those stored blastocysts.

So they need to be compared with freshly made stem cells if you really want to try to get the information because they might be worse by far in terms of any — but you only know that if you look at it to see.

And so to have a moratorium in some sense says, just as Elizabeth said, that you'll never get the information that you want because a scientist would want to get the facts, and if we can say that adult stem cells are better or zygotic stem cells are better, then that would be one thing and we could stop all the other things.

But, on the other hand, if there's a vast difference, we have to know that. I mean, the late Bertrand Russell said something's pretty interesting, I think, and he said the only definitive information comes from science. Dogma comes from religion, and in between is the vast no man's land of philosophy.

What is the evidence? I mean, a scientist would say you have to have evidence. Now, if you think that the way of getting the evidence is absolutely reprehensible, as I guess Gil does, then I would say that he shouldn't modify. I agree with Michael here. He shouldn't modify his stand, and I would respect him for that.

He ought to say no. I mean there's some statement in the document — I know we're not supposed to say it — that no morally unacceptable act can ever be done for any good. I underline that statement.

So if you've got a sniper on the University of Texas tower who has killed 27 people because it's morally unacceptable to kill somebody under any circumstance, then you could never, you know, do that.

So I would say I don't want — I mean, he chastised me on something I said from Augusta in a gentle way, but let me — wait a minute. I'm not quite through.

PROF. MEILAENDER: I'm coming again.

DR. FOSTER: I'm not quite through, but I would much prefer you to simply say, I mean, I don't think this kind of compromise to accomplish a ban like this is really the sort of honesty that you always have reflected on your views.

I understand where you stand. I don't agree with it, but I understand it. So I would much rather have you say, however we come out of this, I don't want to do this no matter how much good can come out of it rather than to say I want to vote for a moratorium so we can get a report out that everybody buys into.

So two points. One is a scientific point, and the second has to do with just your remark. I think we ought to honestly say what we believe here, and whether it's policy or whatever.

CHAIRMAN KASS: You got him once. I got him the second time. Go. No, I'm going to be silent. Let Gil speak.

PROF. MEILAENDER: Just so we're clear, were I to support a moratorium, I would understand it as saying no. All right?

It might mean I'd have to persuade you of that no again four years from now, but that's what I would understand it as saying.

Frank, I think, would understand it a little differently. It doesn't mean we wouldn't at a certain level support the same thing, but that's the way I would understand it, and it seems to me a plausible understanding.

CHAIRMAN KASS: Let me make — I've got a queue of three people and then we'll break for lunch and return. I've got Bill Hurlbut, Mike Gazzaniga, and I think that's — I just wrote Mike. That must be you. Yes?

You can wait until after lunch? Paul? I'm sorry. Did I miss you? Your name is down here scratched out. Have you not spoken?

Bill Hurlbut, after lunch? You can see where the priorities of this body. We'll take a break. We'll reconvene at two o'clock.

(Whereupon, at 12:32 p.m., the meeting was recessed for lunch, to reconvene at 2:00 p.m., the same day.)


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