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THURSDAY, October 16, 2003

Session 3 and Session 4: Biotechnology and Public Policy: Proposed Interim Recommendations, III and IV

CHAIRMAN KASS:  Let's get started.  I think Alfonso is coming back from teaching his class, and Bill I know had a luncheon appointment and told me he might be a few minutes late.  So I think we should begin.

This is the first of two sessions on the staff working paper, part of the biotechnology and public policy project, biotechnology touching the beginnings of human life, and the working paper, the staff working paper "Defending the Dignity of Human Procreation."

Let me take a few minutes to remind everybody of the context of this document and this discussion because it is really a small part of a much larger picture and project.

The Council is engaged in a project to review current monitoring and regulatory institutions and activities concerning the uses of biotechnologies touching the beginnings of human life.  This project emerged when our general interest in regulation of biotechnology was focused by a specific recommendation growing out of our cloning report that we look at issues connected with cloning in their larger natural context, namely, the domain of human procreation, the beginnings of human life, and especially at the intersection of existing practices of assisted reproduction with the arrival of new techniques based on genomic knowledge and the also attendant activities of embryo research.

The major piece of this project was a diagnostic document produced June, July, I no longer remember, but several months ago, in which a comprehensive review of all of the regulatory activities, public, private, federal, state were surveyed, and by the way, this document now, thanks to your comments, suitably revised will be ready for your reading fairly soon, perhaps even by the end of next week.

That diagnostic work showed that the current monitoring and oversight activities have several lacunae and that some of the larger safety, ethical and social issues in this area seem to us to be under-monitored and under-governed.

Third, we recognize that some of the difficulties confronting any wish to fill these lacunae - we recognize that there are quite a number of difficulties in trying to fill these lacunae, and in particular, we recognize the difficulty devising any new regulatory institutions or of revising the duties of current institutions; that to do so is a lengthy and difficult process, and given the polarized public opinion on matters especially concerning human embryos, not obvious that an agreement could be reached even after the lengthy information gathering and deliberative processes take place.  At best these things would take years.

We did think that it was worthwhile in the interim, however, to offer various kinds of interim recommendations.  These were discussed at the last meeting in a session where with some dissent and some request for revision those met with fairly general approval.

I would be happy to report that since that time, following advice given to us at that meeting, that we have been in conversations with the National Child Study Project.  We had a very productive meeting with President of the ASRM and with Sean Tipton for about two, two and a half hours a couple of weeks ago, and we will be revising those recommendations in the light of those conversations, and you will see those things shortly.

Nevertheless, in the meantime the field moves apace; the techniques for embryo growth and manipulation for genetic testing are becoming more sophisticated.  Many new innovations touching human procreation are becoming possible, and the document that you've seen rehearses some of these matters.

In addition, we note that efforts by the federal government in this area have stalled largely because of disputes about the moral status of the early human embryo, and we recognize the kind of deep difficulty we face in developing sound public policy in this area.

Nevertheless, we've aspired in this group, despite our own differences and differences in the country on some of these ethical questions, that there might be, as we've learned from public testimony and our own discussions, that there might be grounds of possible agreement between holders of pro life and pro research positions, between people on the left and people on the right, between scientists and humanists regarding other ethical issues in this field.

And as I say, the recommendations already discussed and by and large approved indicate the possibility of some kind of near consensus on those matters.

However, in addition, we thought that given the events occurring on the ground and given the little likelihood that there would be other bodies whose job it was to monitor and supervise these things, that we might be averting our gaze if we failed to consider what else might be done in the interim while the data we asked for is being gathered and as the fledgling efforts to develop regulatory structures proceed.

And one such interim measure that we discussed for the first time last time would be certain modest congressional action in the defense of let's call it for the sake of discussion now, the dignity of human procreation, and let me reiterate what I take te virtues of such action to be.

First, we could reaffirm and teach about some of the goods that we hold dear.  That has been part of our effort.  It's not simply to go around monitoring and engage in naysaying, but try to lift up to view the positive goods that we think are at stake and that we want to reaffirm.

Second, we could institute a temporary moratorium on certain limited practices, setting a few carefully defined boundaries on what may be done and preventing any individuals from acts that would radicalize what is done in human procreation without prior public discussion and debate.

Third, if these things were drafted carefully, it would interfere but minimally with important scientific research, and on the contrary - and I think this is an argument that one could make to our scientific colleagues - it could serve to protect the reputation of honorable scientists against the mischief of rogues whose misconduct might invite harsh and much more crippling legislative responses.

Fourth, it could place the burden of persuasion on those innovators who would transgress these important boundaries without adequate prior public discussion or due regard for social or moral norms.  It seems to me, to anticipate Michael, that the burden is not on me to say what's terrible about putting human embryos in pig uteruses.  The burden is on people to say why we should do this and what the value is, but we can argue that through.

Finally, and I think this is especially interesting and important, it would demonstrate a way forward for public governance in these areas despite the impasse on the question of the embryo, and it would reveal and set a kind of example that scientists and humanists and people of all persuasions can, in fact, find aspects of our common humanity that we and they are willing to defend collectively and by deliberate agreement.

So, in sum - and I'm simply repeating for the public record things that were in a memo sent to you a month ago, but I want to make sure that it's out there and we're reminded what we're doing here - the exploration of these legislative proposals grows naturally out of the biotechnology and public policy project.  It is informed by our aspirations to a richer bioethics in which certain kinds of human goods are lifted up and shown to be worthy of defense and support.

It fits with our intention to offer interim recommendations while the search for longer term monitoring and regulatory improvement continues.  It seizes a unique opportunity to offer help on important policy questions and to demonstrate how despite these differences sound recommendations can be developed.

It would represent a triumph of our collegial search for common ground, and it might increase the chances that the subjects of our report get the deserved public attention or get the public attention that they deserve.  I mean if you actually make some suggestions that people do something, they at least have to debate the merit of doing it, and that would be an additional bonus.

Now, that's by way of background.  At the last meeting with inadequate preparation we floated some of these items in Part III of the recommendation.  The conversation was wild and wooly.

There was a request that before we return to the consideration of the specific proposals we try to provide something in the way of argument that might lie behind those proposals or justify offering them in the first place.

And in Part I of the document that you have seen that was sent to you at the beginning of this week, Part I is an attempt to give a synopsis, a certain synoptic account of human procreation, emphasizing its biological and especially anthropological significance, and its purpose here is simply to highlight those aspects of human procreation that have ethical meaning and worth, and then to show how certain kinds of possible interventions and actions, possibly only because nascent human life can now exist outside the body, may pose threats to the dignity of human procreation.

I don't want to rehearse that part of the document, but that was in response to the request that we have something more than the mere assertion of prohibitions.

It's the second part of the document which discusses possible legislative measures that could defend the dignity of human procreation against some of the more extreme of those threats listed early  on.

The second part of the document then is a revision of Part III of the recommendations that we discussed last time, and it is going to be the material for the discussion this afternoon.  The more theoretical materials at the front, as I indicate in the document, will be incorporated in the fuller account of the statement of the goods at the beginning of the discussion document that many of you asked for in any case that we flesh that out a bit further.

A couple of things before we proceed.  Some assumptions and sort of ground rules.  I would like to say that although there are certain words in here that might send signals that raise various suspicions, I do not regard this and I don't think it's right to regard this as an ideological document that reflect either a pro life or pro research bias.  It reflects a concern for the worth of things connected with human procreation, not excluding the worth of nascent human life.

It also reflects a deep appreciation of the importance of research.  It's an attempt to be non-ideological in that particular ideological dispute.

Second, I think that there are various people here who are concerned that this effort not involve any repudiation either for the Council or of any individual on the council of positions he or she may have taken in our previous work or in our forthcoming work on other documents.  In other words, we're looking for kind of an agreement not brokered in the cloakrooms where agreement is absolutely indispensable.  We're looking for the kind of agreement where people are going to feel comfortable agreeing to what they agree to because we're trying to offer what would be the opinions of good sense and goodwill rather than our own particular partisan views.

And nevertheless, no one is going to be asked to bend their principles in order to support something here.

Third, I can tell you that comments have been received from a variety of people, and some of them are here and can speak for themselves.  Fair to report, I guess that Mike Gazzaniga has reservations which he can certainly express, I think, about the wisdom of such legislation together, and I should have probably said that sooner.  That was, I think, the one voice in response to my memo that wondered about the wisdom of doing this altogether, and, Mike, you'll speak for yourself either in general or in particular.

But comments have been received on this document to indicate that at least some of these items are in difficulty, but there are various people who can dissent in whole or in part for some of these matters, and we will discover what those are.

Finally, something about this was in a memo to you earlier, but let me say something about the spirit in which I hope we can proceed.

The proof of the pudding here is going to be not in the discussion of the principles, though I'd like you to keep in mind, but more in the particular activities that we might propose for proscription or limitations, and we've tried to narrow these down and eliminate those that we've figured out from the last meeting are not going to fly here, are not going to fly past some people.

We are still trying to land on only those things that we can endorse as a body.  If any of them survive, that would be very good, although I'm not particularly happy about giving each member a veto, and maybe there are some things; maybe we'll revise our views and present mixed reports, if necessary.

But with respect to the discussion, it seems to me that if we set ourselves the task of providing the need to give proof against every possible conceivable objection or reason why something here might not be a good idea, we might be in big trouble.

It seems to me we should probably choose those things where we might expect agreement based upon common sense and goodwill, and to proceed in a somewhat statesman-like way, searching for those agreements of good sense rather than simply looking to find fault.

Our task here in this limited part is, it seems to me, to think of ourselves not as protecting our own turf, but offering sort of wise counsel of good sense to people who are in a position to take responsibility in this area and to provide us some breathing room while the public discussion continues before we're simply overwhelmed by facts on the ground.

Let's see how it goes.   My proposal - if there are questions about the procedure before we get started, we should have them - my proposal is notwithstanding it would be smart to begin with those things on which we could find agreement to begin with, but if I hazard a guess as to what that would be, that will probably simply send up a flag to bring the darts our early.

So I think we should simply go in the order of the things which are here and let the argument go where it will.

Questions or comments on how we're going to proceed, what we're doing here?  Robby is that -

PROF. GEORGE:  Leon, that approach is fine with me.  I wondered though since you cited Michael's general concern about the overall project, whether that's the place to begin before we start going into particulars, or will Michael have another opportunity at some point to give a comprehensive critique?

CHAIRMAN KASS:  Well, I don't want to put him on the spot, and I felt as a matter of just the integrity of the reporting process that I at least owed it to the group to say that when the memo laying out the plan was sent out a month ago, and I asked for comments, I didn't get back comments from everybody.  The comments I got was this plan sounds good to me.

Mike had some reservations in whole and in part, and if he wishes to speak, the microphone is always his, but I don't want to put him on the spot

DR. GAZZANIGA:  Let's just go through it item by item, and I'll comment when I -

CHAIRMAN KASS:  Good.  Thank you.

Are we all right?

We've organized these various items not in the way necessarily that a legislator would do so, but by various kinds of categories.  The first category is under the heading of respect for the humanity of human procreation, preserving a reasonable boundary between the human and the non-human in the beginnings of a human life.

The background text on that is pages bottom of eight, all of nine, if I'm not mistaken, and the three provisions are on the top of page 10.   To prescribe the transfer for any purpose of any human embryo into the body of any member of a non-human species, and that's the pregnancy matter.

And then the other is on the hybrid formation, to prohibit the formation of a hybrid human-animal embryo by fertilization of human eggs by animal sperm or the converse.

And, third, to prohibit the combination of blastomeres from human and non-human embryos to produce a hybrid human-animal embryo.

Maybe there's going to be difficulty on the difference between a blastomere and a stem cell, but what one has in mind here are those early embryos where you disaggregate and recombine in the way in which they produce the tetraparental mouse and the like.

But let's do them one by one and see where we are.  Someone open the bidding on the transfer of human embryos to the bodies of a member of the non-human species?  Please, here we are.

DR. GAZZANIGA:  So to discuss this by example, we go back to the somatic cell nuclear transfer issue with the somatic cell being grown at a rabbit oocyte, and again, the concept is simple.  It turns out that the rabbit oocyte is the  bag of chemicals that would allow this thing to differentiate, grow to the 14-day point, have the stem cell harvested for medical use.

Does this statement and the way you have phrased it in any way impair that sort of thing from going forward?

CHAIRMAN KASS:  Unless I'm mistaken, Mike, you're not speaking about the first item.  You're speaking about the second?

DR. GAZZANIGA:  Yeah.

CHAIRMAN KASS:  Could I ask that we do the first?  Let's just take them one by one rather than take them all as a bunch.

You're speaking really about the hybrid human-animal embryo, right?

DR. GAZZANIGA:  Well, they are related, aren't they?  I mean, preserving a reasonable boundary between the human and the non-human in some sense -

CHAIRMAN KASS:  Oh, no.  You're on target in terms of the category, but I was breaking them out by three different items.

DR. GAZZANIGA:  Oh, I'm sorry.

CHAIRMAN KASS:  Is that all right?  We'll just take these in order.

DR. GAZZANIGA:  Yeah.

CHAIRMAN KASS:  This has to do - what is this about?  This is assuming that one wanted to grow the human embryo past the blastocyst stage for the sake either of research or for the sake of acquiring tissues and organs, and one is obviously little likely to do this in human volunteers, animal hosts might be available for such purposes.

And this is a suggestion that this is not something that ought to be allowed at least until such time as a compelling case is made for it and until we have had a chance to deliberate about it.

And the question is whether there are takers.  Alfonso.

DR. GÓMEZ-LOBO:  I totally agree with the prescription.

CHAIRMAN KASS:  Is there anyone who either doesn't agree or who wants to declare abstention and give reasons?  Paul.

DR. KRAUTHAMMER:  Just a question - sorry - of information.

DR. MCHUGH:  Sorry.

DR. KRAUTHAMMER:  Does this overlap with the first recommendation in Section 4?  I mean, would it be included in it on page 13?

If you wouldn't allow the preservation for the purpose of conducting research on any human embryo past the 14th day, wouldn't this be a subset, or am I missing something here?

CHAIRMAN KASS:  This is probably a subset.

DR. KRAUTHAMMER:  Because in that case it would be easy to deal with.  The issue would be if you can in theory take the fetus to term in this animal model.  That would not be a subset and that would be a different issue.

CHAIRMAN KASS:  Right.

DR. KRAUTHAMMER:  And I think if that's within the realm of reasonable discussion we might want to take that up as well.

CHAIRMAN KASS:  Yeah.

DR. KRAUTHAMMER:  Do you see what I mean in differentiating these two possibilities?

CHAIRMAN KASS:  No, right.  And it's covered in this particular provision "for any purpose."  I'm on page 10 here.

But whatever your purpose, in other words, in Item 4 we're talking about what might be owed to the special respect of nascent human life.  This really has to do with in a way the mixing question.

DR. KRAUTHAMMER:  But all I'm saying is that if we were to accept the recommendation on page 13, this one would automatically follow unless the purpose of placing the embryo in the non-human uterus was to bring it to term.

So in addressing that issue, there's a different set of consideration.

CHAIRMAN KASS:  Comment?  Paul?

DR. MCHUGH:  I have another comment, not to that.

DR. KRAUTHAMMER:  Well, if I can plunge in, I'll be the -

CHAIRMAN KASS:  You're going to -

DR. KRAUTHAMMER:  - Mike's dart board.  No, no, on this, on the implantation in a non-human species.  I'll be Gazzaniga's dart board here.

Let me just propose three possible reasons for why you'd object to this.  The first you might simply call the "yuck" factor.

The second would be having to do with it being a kind of violation of the prohibition on experimentation without consent.

And the third having to do with social control.

The first would simply be the idea of having a child born of pig, to put it rather bluntly, something you wouldn't wish on your own child, and that is simply without reflection repugnant, although that may not be a sufficient reason, but that would be number one.

The second would be the fact that we know that the womb has some kind of physiological effect on the embryo.  It's not all internally determined by the innate development of the embryonic tissue itself.  There's an interaction with the uterus and the host.  We don't know what those effects would be.  We don't know whether or not there would be any pig-like influences on a child, or there could be other kinds of influences which do not have to do with mixing, but simply might be injurious, and that would be kind of a safety issue, and that would be almost insoluble because how would you do the experiment on the first child without harming it?

But the third I think is the most interesting because it generalizes, and it goes like this.  Why do we want the embryo to be housed in its mother?  One of the reasons is that that creates an innate connection between the child and the mother, and the mother becomes uniquely protective and attached.  That's human nature.  It's even animal nature as well.

That even applies in a surrogate mother, and we saw that in the cases where the surrogate refuses to give up the child.  That connection is immediate.  It's innate, and it's very powerful.

And the reason it's useful and it's also human and it's required is because the child is entirely unprotected in the world, entirely defenseless, and by being housed, if you like, in the womb, it acquires a protector instantly, permanently, and indissolubly.

Once you break that connection by placing it in an animal, which would be the first stage of perhaps placing it in some kind of artificial medium in the farther future, that child remains defenseless, and the social implications of that are that it could then become an instrument, a possession of whoever controls the medium, the animal or the official womb.

In other words, you create a thing unattached to any human and, therefore, subject to complete social control by the state, by the company, by whoever is doing this.

And it's not the mixing or the "yucking" that's at issue here.  It may be severing the connection between the child and the mother, which is a way of protecting that child by giving him a belonginghood to someone who will care.  Once you put him in an animal, which is a thing for these purposes, or a machine, which might happen in the future, you create a completely atomized and defenseless creature, and that opens the way to all kinds of tyrannies, social control, and lack of autonomy, which we would not want.

So those would be the three reasons I would see for this prohibition.

CHAIRMAN KASS:  Response?  Michael.

Microphone please.

DR. GAZZANIGA:  If I go down to the local adoption agency and adopt a baby and bring it into the family and give it all of the parental love and care and so forth, how does your analysis fit?

Let's say the baby was born of pig.  Why would I care if I have this beautiful baby?  And the pig metaphor was that science had figured out that it is basically the intermediate artificial uterus that allows for an embryo to grow into a child.

The essential thing for the offspring is that it's cared for.

DR. KRAUTHAMMER:  Right.  Well, you found a case in which a human comes along and picks it up and adopts it and cares, but by creating a system in which you impregnate animals or machines where you carry the machines, you are creating a population that may not have people like you who come along and adopt them.

DR. GAZZANIGA:  Well, anything is possible, but of course, the opposite forces are at work.

DR. KRAUTHAMMER:  Don't you think it's likely?  Do you think those -

DR. GAZZANIGA:  No, I don't think most things you talk about are likely.

DR. KRAUTHAMMER:  To be adopted by caring people?

DR. GAZZANIGA:  I don't think most of the things we're talking about here are likely.

DR. KRAUTHAMMER:  But your scenario of the adoption is the unlikely one.

DR. GAZZANIGA:  Why?  People are dying to adopt babies.

DR. KRAUTHAMMER:  If you create an industry in which you have these embryos being carried by non-human carriers or in machines, you can make limitless production of these, and you're going to assume all of them are going to be lining up outside for adoption?

DR. GAZZANIGA:  I just think that painting the picture that there's the military-industrial complex is waiting to start producing these for a commodity is just preposterous.

CHAIRMAN KASS:  Yeah, I'm basically with Mike actually at least on the facts.  I mean, I think the analysis, Charles, is quite wonderful, and I think also on your side in the last exchange one could say that adoption begins because the children already exist in need.  One doesn't go out to produce them for the sake of adoption.  I mean, this is a matter of rescuing children who have been abandoned rather than somehow producing them detached from their biological roots.

But I must confess that when I looked at this and we worked on this in the office, "for any purpose" didn't strike - I wasn't thinking primarily of bringing to full term.  The reason that I think this is in here primarily is because we've already seen - and the proof of principle experiment was done by Advanced Cell Technologies a year and a half ago, something like that - where they showed the greater value; that showed that putting the cloned cow embryo in and carrying it to several months and extracting primordial kidney tissue was potentially much more valuable than the stem cells, and that therefore, growing embryos to later and later stages might, in fact, be rich in reward in terms of tissue and cell and body parts; and that this is an attempt, I think, to say not that.

Now, you can say that's already covered in the 14 -

DR. KRAUTHAMMER:  Well, that's my point.  It's covered in the other provision.  I was looking at the uniqueness.

CHAIRMAN KASS:  At what was left over, yeah.

DR. KRAUTHAMMER:  The uniqueness of this provision is the one that interests us.  Otherwise why would we have it in there?

PROF. SANDEL:  Right.  Charles is right.  If we're just concerned about that, the 14 days takes care of that.  This only arises if you go beyond the 14 days.

CHAIRMAN KASS:  Rebecca.

PROF. DRESSER:  One thing that makes this a relatively easy one for me.  We are saying this should not be permitted until there is someone, a group empaneled, and somebody wants to do it, and they can give a good reason for doing it.  And it is very difficult for me to imagine a good reason for doing it, and so I feel comfortable saying, well, at least let's not allow it until somebody comes up with an idea or a reason for doing it and has to defend that reason.

CHAIRMAN KASS:  By the way, let's remember also that some of these interim measures are interim in the sense that we do not now have any kind of regulatory body analogous, for example, to the HFEA, which in other countries if there were such bodies there would be an opportunity for someone - I mean, you don't want Congress to sit and judge each time some kind of proposal like this comes along.

But as some of us argued months ago, the only incentive, indeed, for certain people to try to devise regulatory arrangements is, in fact, if there are certain barriers erected which then one has to make a case for proceeding against rather than allow the present status quo in which anything goes.

So, you know, there were hands.  Jim, Gil.

PROF. WILSON:  Perhaps I am puzzled, but I have not heard objections to this first proposal as stated.  Could we go on?

(Laughter.)

CHAIRMAN KASS:  Fine with me, but, you know, I don't want to be - Gil?

PROF. MEILAENDER:  Well, I just wanted to comment.  I don't think Charles was raising an objection so much as simply trying to clarify location, and I would take what I took to be some very nice comments, but I would conclude something a little different from them, namely, that in fact our four categories do overlap and interpenetrate in various ways, and what he really gave was from the angle of one set of reasons, one might place this in Category III, in fact, having to do with concern for children.

CHAIRMAN KASS:  Sure.

PROF. MEILAENDER:  In fact, that's what you so eloquently did.  From a different angle one might place it where it is here; from another angle in Category IV.

I mean, I suppose the system isn't as neat, therefore, as it looks on paper.  Nevertheless, it may be that it has an appropriate place here  as well as some other places.

CHAIRMAN KASS:  Look.  That's pretty terrific, and one of the things - one, I think the nicer points made in the earliest part, the part we're not discussing, is once the embryo exists in vitro , it's very easy to begin to treat it in absolute isolation from all of its natural relations, and you reify the embryo, the blastocyst, and you -

(Pause in proceedings in response to fire alarm.)

DR. KRAUTHAMMER:  Oh, that's great.  We have to vote where it is.

CHAIRMAN KASS:  Somebody didn't like what I was saying.  So I think I'll stop.

No, it had to do with the disaggregation of this whole picture of reproduction and our own analytical -

(Pause in proceedings in response to fire alarm.)

CHAIRMAN KASS:  Someone is calling right now to find out whether this is a mistake.  Let's hold for a minute.  Our administrative people are calling to see whether this is an error.

Shall we go on?  Are we okay on this point and proceed.  Maybe that was the sign that we should get to the next point and stop talking about this one.

The two things have to do with the hybrid human embryo.  One, and here, Mike, I think is where your comments would come, the fertilization of human egg by animal sperm or animal egg by human sperm.

Rebecca.

PROF. DRESSER:  Could I ask a question about this one?  In preliminary material to these provisions, I wasn't clear whether the discussion was focused on just a mere creation -

(Pause in proceedings in response to fire alarm.)

CHAIRMAN KASS:  Out.

(Whereupon, the foregoing matter went off the record at 2:43 p.m. and went back on the record at 2:59 p.m.)

CHAIRMAN KASS:  All right.  This drill that we just had was actually engineered by Paul McHugh who wanted to give some boys a little extra recess.

DR. MCHUGH:  More recess, less Ritalin.

CHAIRMAN KASS:  Actually, I'm reminded while we're waiting also for Robby that I have two statements that I meant to read, too, one from Dan Foster, which is pertinent to where we are, the other from Mary Ann.

"As you know, in general, I have a high view of science.  I have just submitted an editorial in response to a paper saying that the disease model of medicine was dead and, by implication, the science of medicine.  I cited myself at the end of a debate about science and medicine before the Association of Professors of Medicine, the Chairs of Medicine in the 125 medical schools.  I said, 'I wish to make a profession of faith.  Science will win.'

"But I also think that we should not always do what we can do.  Daniel Callahan, whom we heard recently, wrote an article called 'Living with the New Biology' in Center Magazine , 1972, in which he coined the terms 'power plasticity,' on the one hand, and 'sacred symbiotic' for two models of human thought and behavior.

"The late Richard A. McCormick, the Jesuit moral theologian and bioethicist, picked up on this in his book How Brave a New World called 'Dilemmas in Bioethics.'  McCormick wrote, 'First there is the power plasticity model.  In this model nature is alien, independent of man, possessing no intrinsic value.  It is capable of being used, dominated, and shaped by man.  Man sees himself as possessing an unrestricted right to manipulate in the service of his goals.  The model that seems to have sunk deep and shaped our moral imagination and feelings shaped our perception of basic values is the power plasticity model.  We are corporately homo technologicus .  Even our language is sanitized and shades from view our relationship to basic human values," end of quote from McCormick.

Now, Dan Foster again.

"I think there should be restrictions on the boundaries of the power plasticity model, and I think the suggestions in the document are reasonable.  I'm sorry I cannot be there to discuss with the colleagues, but I am in favor of congressional limitations in the general areas listed, especially human-animal mixtures.  Please share my thoughts."

And while I'm at it, let me just read the shorter comment from Mary Ann.

"Regretful as I am that I cannot be present for the presentation of 'Beyond Therapy,' I am even more regretful to miss the discussion of the important working paper of biotechnologies touching the beginnings of human life.  New developments in this area announced almost every week make it urgent for the Bioethics Council to make clear what is at stake.

"The recommendations in the working paper seem to me to be appropriately modest.  I am especially appreciative of the recommendations addressed to protecting women against the exploitative and degrading practices in Item 2 and of the attention paid in Item 3 to children born with assisted reproductive technologies.  Item 3 is a helpful reminder that children in our society are often the forgotten parties when adults pursue their own personal or scientific aims.

"If adopted by Congress, the recommendations in the working paper would mainly serve to provide time for study and public deliberation before fateful boundaries are crossed to the detriment of human values that most Americans hold dear.  I very much hope that the Council will give its unanimous support to these minimalist but essential recommendations."

That's from Mary Ann Glendon on her way abroad.

We are back then to the second and third, and we can take these two things up together.  Rebecca, please.

PROF. DRESSER:  I was starting to ask a question, which is for the second and third.  Is this intended to cover the creation of these embryos for research, as well as to bring to term, and I wondered if it is intended to cover the creation for research.  Does that mean that it is more acceptable to conduct research on a human embryo until 14 days than it is to conduct research on a hybrid embryo?

And if the hybrid animal embryo is somehow worse to create as a research tool when we're allowing it with human embryos, something doesn't click.

CHAIRMAN KASS:  Someone want to speak to this?  If not, I will.

Charles.

DR. KRAUTHAMMER:  It's, again, that same distinction that we talked about earlier.  I mean, obviously  only in science fiction would we imagine that these would come to term, but the question is should we/should we not create these hybrids for what other purpose?  I mean, is the very act of creating them what we want to prevent rather than their exploitation?

So, again, if we're worried about only exploitation, then it could be subsumed under the other provisions, but the question is not whether it's okay to experiment on them or to use them, but whether we want to see them created in the first place, and I think that's a different question.

CHAIRMAN KASS:  Rebecca.

PROF. DRESSER:  Well, I guess one thought I have is if there were scientific knowledge that could be gained through looking at either a fully human embryo or a hybrid human-animal embryo, I might prefer to learn it through the second.

DR. KRAUTHAMMER:  Well, then if your answer is that, the question then to you would be:  would you do that at the cost of breaking a theoretical or moral barrier, which would be the creation of this hybrid entity in the first place, and you might answer yes, but there might be people who would say, "Well, you want to build a fence around this idea because once you do that, what might happen, what might eventuate might be something you wouldn't want to see.

In other words, this might be a principle you might want to preserve, not mixing for its own sake.  So I think that is the issue on the table.

CHAIRMAN KASS:  Right.  Michael.

DR. GAZZANIGA:  Well, to go back to your point, Charles, of the 14th day issue, if this set of recommendations had the added limiting factor to prohibit and take to term, I don't think there's anybody here that would have any disagreement with these proposals.

The question is:  are we somehow tying the hands of basic science by not allowing certain laboratory procedure to go forward to 14 days and then they have to be stopped by regulation?

And in fairness to the biomedical scientific community, I don't know what those experiments are.  I certainly don't have them on the tip of my tongue, but one can imagine easily experiments that could be undertake, and I'm completely in agreement with Rebecca's point that the logic seems strange.

CHAIRMAN KASS:  Well, the logic seems strange.  I think Charles' answer is certainly an answer close to my own, and I don't know what the scientific value would be from doing these particular experiments, but let me concede that there would be some.  I mean, somebody would imagine something that one would be learned, and yes, I think the question is:  does one intend to get - if one adopted this, would one be deliberately getting in the way of that particular kind of experiment?

The answer is yes.  This is not primarily or exclusively intended with respect to the question of bringing to term.  This has to do really with mixing at an organismal level, at the beginning of an organismal level, at the germ of a new organism, animal and human, quite apart from the subsequent use that's made of it, and you can say, "Well, what's the harm?"

And then the question is whether this is one of those ethical issues in which demonstrable harm in terms of utility has to be demonstrated or whether we're dealing with one of these boundaries of taboo where you say what would somebody be thinking or what kind of sensibility would be required to do this and not blink, and should somebody who's inclined to do this without blinking come before people who blink a lot and make the case and let's discuss it rather than say this is a boundary that's open for transgression.

And it's really no different from vaccination, like that, or no different for other kinds of experimentation with other species in vitro .

So I want to separate.  This really does have to do with the human-animal boundary.  That's why it's here.  Now, there would be an overlap in other places, but it's deliberately, I think, intended to say - and I would, by the way, appeal to the scientific community and say, "Look, guys.  Don't you think it's actually in your interest to say we don't want to do this?" 

This is not a boundary where we're ready to cross until there's powerful, good reasons that we should make to do it rather than say this boundary is open, is porous to anybody who wanted to walk across.

I would think it's in the interest of the scientific community to say we support this.  We come forward and we join the conversation and we say these are self-imposed limits that we have set on ourselves.  Now, maybe I'm naive.

DR. GAZZANIGA:   Leon, you're a lot of things, but you're not naive.  I promise you that.

I think that's a fair question.  So why don't you put it to the National Academy of Science and ask them that question and let the people who work with this problem every day, you know, send an evaluation of the point?

I think, you know, if they said, "We don't want to go anywhere near this," that's of use, and if they say, "No, we can think of 12 things as to why you should consider this up to 14 days," or whatever, that's another point.

But just to be kind of shooting from the hip here I'm not comfortable with.  I need more time to think about it.

CHAIRMAN KASS:  Okay.  Michael Sandel, Robby and then Paul.

PROF. SANDEL:  Well, I liked your formulation just now about whether scientists who have a compelling or what they consider compelling reason to do an experiment that might fall under one of these prohibitions should have to bring it before a body of people more inclined than they to blink and who take seriously the ethical concerns and principles of the kinds laid out here.

But that model, that requirement that there be that kind of check suggests that we should reconsider an idea that we discussed at the outset of this project of calling for the creation of a regulatory body of people who blink for the very reasons that we have been discussing.  We don't know sitting here as a body; I certainly don't feel that I know what likely scientific experiment of some importance, if any, would conflict with these prohibitions.  I don't think any of us knows.

And so you say rightly, "Well, then don't we want to put the presumption on the scientists to come forward and show that this particular experiment, though it seems to violate these principles or may actually violate them, would be justifiable, all things considered."

But the mechanism of a congressional prohibition doesn't invite that.  What would invite that would be our enunciating these principles, laying out even these prima facie prohibitions, but presenting them as prima facie prohibitions or presumptive ones and say that anyone who has a project that would involve the violation of these principles should have to get authorization from some body of people who are alive to these questions, who can consider on a case-by-case basis whether the scientific need is compelling or not, and then to make fine tuned moral judgments about whether what we care about really is implicated or possibly competes with the scientific promise, and decide on a case-by-case basis isn't the need for that exactly what led us originally in this project to say maybe we should call for some kind of regulative body.

This was Frank's idea.  This was, I think, Rebecca's idea as well, and I think the fact that we don't have this knowledge and here we're inviting Congress to enact these prohibitions when we don't know.  Maybe this is so farfetched that the scientists would never want to do it.  Maybe only rogue scientists would.  Maybe there's real science that two or five years from now would be prohibited by this. 

There's no mechanism to bring it.  Whom are they going to bring it before?  The Senate or the House Commerce Committee?  I mean, there isn't anybody.  We're not going to be around or may not be.

CHAIRMAN KASS:  Jim, do you want to respond to that?

PROF. WILSON:  Yes, I do.  I share your concerns, Michael.  I have never been an enthusiast about creating a regulatory commission because I did not think we knew enough about the subject to design one, but I do think that one is in order for the management of this kind of problem because the scientist can't go to the Senate  Commerce or the Senate Judiciary Committee, whichever it may be.  What if we put on page 7 of this document under Roman numeral two, eight lines down, after the phrase "we believe Congress should consider some limited targeted measures together with the creation of a regulatory commission that might give expression to and provide protection for"?

We don't design it.  I don't like designing regulatory commissions on the spur.  Congress designs them, and it knows more about them than I do, and at least it would give people a chance to come back and make the kind of argument you're talking about.

PROF. SANDEL:  I would, if I may, I think that would be an excellent idea, and I would favor that amendment to this with one further provision:  that we cast - and I don't have the language in front of me - that we cast all of the prohibitions that follow as presumptions that any such regulatory commission should weigh in assessing the scientific merit brought before it rather than outright congressional prohibitions because that would defeat the purpose of the commission.

DR. KRAUTHAMMER:  Do you want to open up the post 14-day prohibition to appeal?

PROF. SANDEL:  Well, I'm not sure.

DR. KRAUTHAMMER:  I'm just asking.

PROF. SANDEL:  Maybe not.

DR. KRAUTHAMMER:  Do you want to put all of them in this tentative state -

PROF. SANDEL:  No, that's a good question.

DR. KRAUTHAMMER:  - or maybe not.

PROF. SANDEL:  Some, but not all.

DR. KRAUTHAMMER:  Or can we declare a few of them inviolable?  That's my question.

PROF. SANDEL:  Right.  We can discriminate between them and among them, yes.  That's a good point.

CHAIRMAN KASS:  Still on this particular point, Robby, or are you going somewhere else?

PROF. GEORGE:  You might want to give it to somebody else.  Go ahead.

CHAIRMAN KASS:  Gil, do you want to respond to this, to the ongoing?

PROF. MEILAENDER:  Yes, with two comments which I'm afraid pull in several different directions, but still pertinent to where Rebecca started us.

It seems to me that there may be things that I think I know should be prohibited, about which I don't need to know any more about what possible gains there might be from doing them.  There may well be such things as I think it what Charles was raising here, and so rather than immediately turning to the notion that we should recommend a regulatory commission, which I at least am not at the moment prepared to recommend, it seems to me that the thing to do is to talk about whether we have in our list any things that we do think we don't really need to know more about what good might result from doing them in order to believe that they should be prohibited.  That's the one thing, and that cuts in one direction.

Now, the other thing I have to say is that Rebecca did raise a significant point about kind of internal consistency of the - I think she has really made me - she has raised for me a point that I had not, in fact, considered, and I wouldn't want to consider it settled just because the conversation moves on.  It take it to be a serious point.

CHAIRMAN KASS:  On the substance of which you don't want to say anything more?

PROF. MEILAENDER:  Well, I need to think more about the peculiar fact that this set of recommendations as a whole, if somehow we were to take them as a whole, would somehow make impermissible some uses of human animal hybrids that would not be impermissible human embryos.  I just need to think more about that.

It strikes me that we shouldn't just move on and assume that's settled.  That's all.

DR. KRAUTHAMMER:  Gil, what's impermissible is their creation, not their use.

PROF. MEILAENDER:  I understand that.  I understand that.  That doesn't mean that there might not be a kind of very peculiar paradox opened up by the set of recommendations as a whole.  That's all.

CHAIRMAN KASS:  I had Robby and then Bill.  Robby, go ahead.

PROF. GEORGE:  Yes.  Well, looked at from my perspective as someone who believes that the fully human embryo deserves formal respect and that, therefore, in an ideal circumstance we would forbid disruptive research on embryos.

I'm very willing to support the language that we have here on hybridization, and some of my reasons have already been articulated by Charles, but another reason that goes back to something Jim said in our debate this morning is that I just don't think we can know what the status of such an embryo is, what the moral status of such an embryo is.  I think it would be very opaque and hard to figure out.

Now, I realize that that won't necessarily be a problem for someone who believes that research involving the destruction of a fully human embryo is morally acceptable.  You would then reason that, well, whatever respect is due to this hybrid embryo, it's no more than, perhaps less than, that due to the embryo, but of course, that's not the position I find myself in.

Gil, I share your sense of it's worth thinking about the anomaly that is created or would be created that Rebecca has brought to our attention, but here just as a preliminary comment, I might say it's probably an occasion to try to think the thing through in the statesman-like way that Leon suggested at the beginning rather than just looking at it as a philosophical problem.

It may be that there is sufficient support on the Council and the Congress and the community at large and the political community at large and the country for the prohibition that's being proposed here for a series of reasons, different people having different reasons, some overlapping reasons.   We've already had different reasons adduced here.

I think that would be a good thing even if from our perspective we're not in a position to forbid something that we think could conceivably be an even worse thing.

The other thing to keep in mind is that while Rebecca's point is definitely an interesting one and does suggest a possible anomaly, the option is not practically before us of substituting research on  animal-human hybrid embryos for the research that is going on and will go on on fully human embryos.

Let me just conclude by saying I've been using the phrase "fully human embryos" simply as a term to use to distinguish it from an animal-human hybrid.  I'm not suggesting that an animal-human hybrid in any particular case would not be from a moral vantage point fully human.  I just don't know, and as I said at the beginning of this comment, I don't think we can know.

CHAIRMAN KASS:  Bill.

DR. HURLBUT:  Are we talking about the last section here, too?

CHAIRMAN KASS:  I beg your pardon?

DR. HURLBUT:  Are we doing the second and the third items on this?

CHAIRMAN KASS:  Together, yeah.

DR. HURLBUT:  Okay.  Rebecca's point seems to me a very good one, that there might be reasonable distinction between what we call a normal human embryo and some kind of combination entity, and it seems to me that that might actually be a way that would open some possibilities for legitimate moral research in the long run.

And this harkens back - I hate to bring it up - to the speculative proposal I made where what was created would not be called an embryo by any reasonable terminology because it simply didn't have a human future, either a human present or a human future.

Now, we know that you can get or it at least appears that we can get oocytes from ES cells.  We also know we can genetically modify ES cells in culture.  So what does that tell us in terms of what we might be able to produce that might be very useful in scientific projects that would not reasonably qualify as human embryos and yet be capable of producing, for example, lines of ES cells.

And if you start with something in a Petri dish, you can modify it very significantly so that you take out enough of its genetic material that you don't have any reasonable similarity to a human embryo, and yet you would be using what might be called - maybe you define it that way - but you might call these entities gametes or blastomeres even.

What I'm really trying to say in this is that the suggestion that we make a certain set of recommendations and then suggest an advisory panel to discern the objections or proposals, essentially would be putting onto that advisory panel exactly what we should be doing as a Council.

PROF. SANDEL:  Except it wouldn't be advisory, Bill.  It would be regulatory and have the force of law.

DR. HURLBUT:  Well, just the same, they're going to have to make the same difficult bioethical determinations that we should, and would they necessarily have the qualifications for doing so?  Who would they be?

I mean there are fundamental bioethical questions here, and it seems to me we just can't escape them.  We have to address them as we tried to this morning.

What constitutes a human life?  What is it we're trying to protect?

If we don't do that hard work of the fundamental ethics, then we're just going to end up with a series of problems that we can never really resolve.

CHAIRMAN KASS:  A few more comments and I think I'm going to try to take the temperature of what we have to do on these points and move on because otherwise - let's see.  We've got Paul, Michael, Bill May, Michael, Robby, Rebecca.

(Laughter.)

PROF. GEORGE:  Take me off.

CHAIRMAN KASS:  Paul.

DR. MCHUGH:  Yeah, I wanted to make some general comments in relationship to these proposals.  On my reading of them, essentially I agree with all of them, but on a closer reading I want to come back and speak to two issues.

One, that these wordings do not say that we must do research on full human embryos.  We're not saying that.  We're saying the 14 days and all.  We're just saying no more than that.

The reason, of course, I am concerned about this is that I also believe that we shouldn't be doing research on gamete produced, two gamete produced human embryos.  I just don't think we should do that.

The whole reason for my enthusiasm for somatic cell nuclear transplantation is that I don't see them as embryos in that kind, and so part of my problem with this first section here is that any human embryo is being used here, again, with the implication that it could be that we include SCNT cellular things as in any embryo.

Now, even in SCNT I don't want to put into another uterus of anything, but the second part here, I want to think about SCNT as tissue culture in which it might be possible not to have a human egg and a human sperm fertilized or fertilizing, but that it might be a possibility in SCNT work where you would use a bag of protoplasm from some other species.

And I want to make it sure that when I'm discussing human embryos what I mean by human embryos is embryos produced by two human gametes. Okay?  That's what I mean by it, and then all of this stuff flows okay with me.

CHAIRMAN KASS:  Okay.  Well, this is the place to answer Michael's question earlier about whether or not -

GAZZANIGA:  Same point.

CHAIRMAN KASS:  Same point, and that there is an ambiguity such that that is a question means that it's not sufficiently carefully written.  It was not intended to cover that.

DR. MCHUGH:  Yeah, that's what I thought.  I thought I was happy with -

CHAIRMAN KASS:  This is egg and sperm.

DR. MCHUGH:  Eggs and sperms.

PROF. SANDEL:  Which passage are we on?

CHAIRMAN KASS:  We're still in the same old place, the middle of the three.

PROF. SANDEL:  Page 10?

CHAIRMAN KASS:  Page 10 in the central of the three.

DR. MCHUGH:  Yeah, central of the thing.

It's not as if they talk about human eggs and human sperms and animal eggs and animal things.  I'm for this.

CHAIRMAN KASS:  Meaning with the genomes, not -

DR. MCHUGH:  Yeah,

CHAIRMAN KASS:  That was the intent.

PROF. GEORGE:  Leon, would it be possible to fix this very easily simply by noting either in the text or in a footnote that on the question of SCNT, that has been addressed by the Council in the previous report, and nothing in this report -

CHAIRMAN KASS:  Yeah, exactly.

PROF. GEORGE:  Okay.

CHAIRMAN KASS:  I think there's a way of leaving that to the side because people disagree on that, and therefore we're not.

DR. MCHUGH:  Yeah, un-huh.

CHAIRMAN KASS:  Let's see.  We've got Michael.

PROF. MEILAENDER:  Would you just clarify one thing for me yet on what you just said?  On the third prohibition, blastomeres from human and non-human embryos, there is a hybrid human-animal embryo.  So you're saying that that was not intended to cover hybrid produced from animal and cloned human embryo?

CHAIRMAN KASS:  No, no.  It was the middle one I was speaking to.  There are these experiments where people have put human nuclei into enucleated rabbit eggs.  Is that the kind of hybrid that is here being talked about?

Probably not.  It's certainly not intended to be talked about here.  Now, there's the question about whether it's the rabbit mitochondrial DNA, those whatever, 18 genes or however many there are.  But mainly what one wants no one is going to think that what you're going to get out of that is something that is a hybrid being, whereas if there is to be any possibility of a hybrid being, it would be by mixing of the genomes.

PROF. GEORGE:  But I see Gil's point on number three.  You do have an issue.

CHAIRMAN KASS:  I don't see why.

PROF. MEILAENDER:  Well, I just wanted to know whether the human embryo there meant only the human embryo formed from two gametes or whether it might mean the human embryo produced by SCNT.

PROF. GEORGE:  I think that's just a question for Paul, whether Paul would see that as -

DR. MCHUGH:  I'm using the word "embryo," once again.  "Embryos" mean something produced by two gametes.

PROF. GEORGE:  So you would not find it acceptable for number three here to include comprehensively all such.

DR. KRAUTHAMMER:  We may need a footnote here.

CHAIRMAN KASS:  We'll sort this out.

DR. MCHUGH:  We need more than a footnote.

DR. KRAUTHAMMER:  We can do a footnote.

DR. MCHUGH:  One of the reasons I wanted to be sure about SCNT was primarily for number two.  I agree even with SCNT for number one anyway.  I don't want SCNT products to be put in so we can eat the giblets later on.  I'm against that.  I'm against the whole giblet approach.  Okay?

And the reason I want to do that is because I'm looking for stem cells and the whole stem cell opportunity, and so I think I'll have to think more about it.  I also would not want to use SCNT products in their blastomeres to combine them with human embryos.

PROF. GEORGE:  You would not.

DR. MCHUGH:  I would not.

PROF. GEORGE:  So you wouldn't have any problem with three even if it did comprehend.

CHAIRMAN KASS:  Let me ask.  I now can no longer remember the queue.  There were a number of people who wanted in.  Michael, Michael, Bill May, Rebecca, and I'm not going to add anybody else.  We're going to move on after that, and let me ask you to be brief.

PROF. SANDEL:  I just wanted to go back to Jim's suggestion, which I think is a very good one, that we call for a regulatory, not advisory, a regulatory body that would be empowered by Congress, and that we cast these prohibitions for the most part as principles or presumptions that can only be overridden by a showing of compelling scientific need as determined by this regulatory body, with the exception, to respond to Charles' case, that one or more of these we may decide to pluck out and say these are appropriate for congressional enactment rather than this regulatory body.

And there I would include, following Charles' suggestion, for congressional enactment on page 13 under number four, prohibiting the use or the preservation solely for the purpose of conducting research on the embryo past 14 days, but to cast the others in this other way.

CHAIRMAN KASS:  Well, let me say that decision was made in the discussion some meetings ago that we were not, in fact, ready to recommend as a body the creation of such a regulatory body.  Part of the reason was that there was all kinds of information lacking both about the magnitude of certain kinds of difficulties, as well - in fact, there are even people who think that any regulatory body might be worse than none at all.

And we sort of tabled this for further deliberations by us as we went forward, and the question is what could we say in the interim.

Now, I'd be much happier to say if there are things here which are controverted, if there are things here which people think really don't somehow stand the test of gravity sufficient to be included on a list comparable to the Item 1 here or to things which are coming under Points 2 and 3, then we should drop them rather than to - I mean, I'm happy to say that Congress should consider the desirability of establishing such a body, but I don't think we are yet at the place where we can say this is what they should do.

This is I think what we should say in the interim while we continue to deliberate and invite them to do the same, and I'm pretty sure I'm reporting more or less the sense of the meeting where even Frank, who is, I think, the Council's zealot on the subject, accepted that as the present state of things.

PROF. SANDEL:  Well, some of us went along with that decision.  It wasn't a vote.  Some of us went along with that decision, but then when we found the list of things that we are asking Congress to prohibit and found that we don't know how compelling is the scientific need on the other side, for example, of the second item on page 10 and others, I think that has led some of us to think that when we actually get down to the list of what we are telling Congress to prohibit - now, it can be said this is interim and it is simply shifting the burden of argument, but, in fact, these are not cast as a four-year moratorium.

These are cast as congressional prohibitions.

CHAIRMAN KASS:  No, no.

PROF. SANDEL:  What we're asking Congress to recommend.

CHAIRMAN KASS:  The recommendation would be cast in terms of a call for a moratorium if we were to make it.

PROF. SANDEL:  With a certain number of years attached as we did before?

CHAIRMAN KASS:  To suggest with a lapse in review, absolutely.

PROF. SANDEL:  What would be the period of years for the moratorium that's proposed here?

DR. KRAUTHAMMER:  Fifty.

(Laughter.)

DR. GEORGE:  Five hundred.

DR. KRAUTHAMMER:  Could I make a procedural suggestion?  There's a disagreement over whether on items like two or three we should either have a regulatory body or, as Leon suggests, leave it off the list.  In other words, it's either/or.

So why don't we defer that question as to what we do with this other category of provision and see if we can make a list of those on which we would agree on absolute prohibition?

That would get us to at least a starting point, and then we could revisit the issue of the other ones.  Do we want regulation or do we want to just leave it off the list for now?

CHAIRMAN KASS:  Excellent suggestion.

I'm still not remembering the queue.  Mike Gazzaniga, Bill May, Rebecca, and onward.  Bill?  Mic, microphone, please.

DR. MAY:  I'm attracted to  Charles' proposal as a way of moving ahead.  I had thought it might be helpful just to ruminate over the fact that we really have used the word "barrier" over again, and it's very interesting that you point to the barrier creating, as that's what distinguishes it even though you're talking about use in one case, use in the other case.  But it's the creation of the interspecies that creates a special problem.

For what it's worth, it seems to me barriers operate at a number of levels.  First, in traditional societies, the whole notion of taboo, usually kind of divine in origin or at least sacred, protecting something valuable.

In this paper, the preamble is directed to what we want to protect that is valuable, but the second dimension of taboo, of course, was that frankly crossing that boundary is fraught with danger, and it's not simply the danger that you'd be punished if you cross that boundary, but you're playing with something that ought not to be played with.

Taboo established a zone of danger, and elsewhere you can play.  And in a sense you're saying to science, "Here's a zone of danger.  If we ought not to enter in here, you can play elsewhere with whatever you're up to."

You did have us read that paper by Midgley, is it?

CHAIRMAN KASS:  Right.

DR. MAY:  Where you're not appealing back to traditional society, but talking about emotional barriers which is kind of a residual of taboos in traditional societies, I suppose, the so-called yuck factor, a border that if you cross it, disquiets or disgusts if not the person who crosses the border, the society at large.

Third, we then talked about barriers at a legislative level, and presumably not artificially constructed because they're reflecting.  An emotional sense of this is something that we should not be up to, warranted because it reflects barriers at Levels 1 and 2, either custom, customary human practice or where there's an emotional reflex that signals something significant.

And then, four, set up a committee to review these matters, again, a barrier, a kind of barrier with a burden of proof based on those who would want to cross the boundary, and you, I guess, would either get a lot of proposals and these people would end up gatekeepers or there would be no work to do because, as Mike Gazzaniga suggested, in lots of cases we're really talking about rather exotic things that aren't going to happen and so forth.  So they would be bored at their jobs.

The last point was your secondary appeal to the notion of the self-interest, maybe the scientific community in accepting barriers, either legislative in your case or regulatory in the case of Michael and Jim, but still a barrier because you're putting it in terms of a burden of proof and not simply inviting proposals.

That's a very important distinction it seems to me.  You set up regulatory bodies that are inviting proposals.  That's one thing.  It's quite another thing to say, "Here are our gatekeepers of a fence that really basically we assume we ought not to be crossing."

CHAIRMAN KASS:  Really very lovely, Bill.  Thank you very much.

Rebecca, and then we're going to move.

PROF. DRESSER:  Two things we would give up if we didn't say something about some review body would be that we might end up endorsing a congressional not quite prohibition, but constraint on just a couple of these things and we wouldn't be able to say, well, we do have a lot of reservations about the rest of these things, and we want some sort of precautionary principle in place where these would not go forward without thorough consideration.

The benefit of such a committee would be that they would be able to get the specific case, and they would be in a better position than we are for some of these things to evaluate, and I don't feel equipped to endorse blanket prohibitions on some of these things because I don't think I know enough about them, and if there is a review body, they would be able to get the facts of each case and evaluate them.

Now, we can certainly, and I think in here are some general principles that we would want them to apply morally, but that's what I think they would have that we don't have.  So I don't think we would just be passing the ball to them.

The other thing is it seems to me that this document takes some steps toward that because it says these measures perhaps collected in a dignity of human procreation act would remain operative at least until policy makers and the public can discuss the possible impact and human significance of these new possibilities and deliberate about how they should be governed or regulated.

Now, I agree to say, "And we think, Congress, you should set something up," it would be another step, but this does move in that direction.  It's not saying these are terrible and we should never ever do them.

CHAIRMAN KASS:  I know exactly.  Point absolutely well taken.

Look, Mike, please.

DR. GAZZANIGA:  Just to make it a little more complex, you asked us not to speak about the set-up for these issues in the first few pages of this, but you know, there are many ways the issue of human procreation could have been characterized.  You chose one and wrote on it with your usual eloquence, but others might choose it differently, and what we're giving up here is the fact that your view may not be my view or Jim's view or whoever's view.

So that when this goes forward to the general public, I think the more that you retain the language of the current framing, the more reaction that maybe a set of reasonable suggestions is going to be resisted, and if there's some way of taking out of it the laden language that triggers those sorts of responses, I think it serves the general purpose here of what we're trying to do.

CHAIRMAN KASS:  Point taken.

Onward.  Item 2.  To summarize, I take it of these three points, Item 1 stands without dissent.  Item 2 and 3 belongs on the list for what to do with them after we're finished.

Item 2 is under the heading of respect for women and human pregnancy.  I'll assume that the introductory paragraph has been read, but the basic point is that a woman and her womb should not be regarded or used as a piece of laboratory equipment, as an incubator for growing research materials or as a field for growing body parts.

And here the language might be that people have complained about the ambiguity of the language.  So it's put in "prohibit the initiation of a pregnancy using embryos produced ex vivo for any purpose other than an attempt to produce a child, a live born child.

The other way to put this would be to say prevent the transfer into a woman's uterus of a human embryo for any purpose other than the attempt to produce a live born child.

The latter is probably clearer.  The reason that it was originally put the other way was that no one should suspect that this particular provision has anything to do with the embryo question.  It has to do with the woman question.

But I'm happy to recast this so that it's unambitious, so that it's clear.

PROF. WILSON:  I'd like to vote for the recasting because the phrase "prohibit the initiation of a human pregnancy" will strike some readers, and indeed, struck me until I read the document three times, as a ban on IVF procedures where almost inevitably excess fertilized eggs are produced and then stored.

What you mean, and I clearly understand, is that you do not want a fertilized egg placed in the womb of a woman for any purpose other than to develop a live born child.

CHAIRMAN KASS:  Right.

PROF. WILSON:  State it that way and I'm happy as a clam.  So I vote for the alternative.

CHAIRMAN KASS:  Is there anybody who's unhappy with the reformulation?

PROF. GEORGE:  What would the language say exactly.

CHAIRMAN KASS:  To prohibit the transfer into the - part of the reason that I also didn't - we'll find the right language.  I don't want to start treating a woman as the home of a uterus.  It was that kind of language that I was resistant, which is why the initiation of a human pregnancy seems to me right.

But to transfer into a woman a human embryo for any purpose other than to attempt to produce a live born child.  That's what we're talking about.  If a human embryo goes into a human wound, it's for the sake of trying to produce a live born child.  That's the idea.

PROF. WILSON:  And I would elevate this to the ranks of the nonnegotiable.

CHAIRMAN KASS:  Yeah.

PROF. WILSON:  The regulatory.

CHAIRMAN KASS:  I should hope so.

PROF. SANDEL:  Right.  Provided it's cast in this clarified way.

CHAIRMAN KASS:  Yeah.  This is not, by the way a ban on - this is not somehow the endorsement of the creation of embryos.  It's talking about if an embryo goes into a woman's womb, it's for this purpose and this purpose only.

PROF. GEORGE:  No problem.

DR. KRAUTHAMMER:  You're started with a created embryo ex vivo .  That's assumed.

CHAIRMAN KASS:  Ex vivo .

DR. KRAUTHAMMER:  Right.  That's assumed.

CHAIRMAN KASS:  That's where all of this begins.

DR. KRAUTHAMMER:  If that already is the case, then our prohibition applies.

CHAIRMAN KASS:  Well, almost all of these things begin with that starting point, yeah.

Alfonso.

DR. GÓMEZ-LOBO:  The initial question.  So are we or are we not understanding the initiation of a pregnancy as the implementation in the uterus?

CHAIRMAN KASS:  We're not going to use that language.

DR. GÓMEZ-LOBO:  Yeah, but it would be important for me to know.  My understanding was that the pregnancy would start at - do we define the initiation of pregnancy at that point or at the point of fertilization?

CHAIRMAN KASS:  In normal life, in the absence of in vitro techniques this question doesn't arise.  I don't think you would say the pregnancy is begun in the Petri dish.  Something else may have begun that's of worth, but you don't have a pregnancy until the thing is in the woman, right?

DR. GÓMEZ-LOBO:  Okay.  Thank you.

CHAIRMAN KASS:  I mean that's -

PROF. SANDEL:  So just to clarify, this falls under the category of respecting the dignity of pregnancy and pregnant women.

CHAIRMAN KASS:  Right.

PROF. SANDEL:  This has nothing to do one way or the other with the status of the embryo.

CHAIRMAN KASS:  Yeah, which was why I had wanted not to put the embryo up front, but it's clear that the ambiguity requires us to do it otherwise, and it will be fixed.

Comments, questions on this?

(No response.)

CHAIRMAN KASS:  Okay.  Onward.  The next point has to do with respect for children who are conceived or born with assisted reproductive technologies, and here the idea is that  just because it is now possible to initiate a new life ex vivo and wonderfully children are born as a result of that, that various kinds of manipulations ought not to be conducted that would deprive the children who are born as a result of this, beginning with any of the rights and attachments that are naturally available to children born in vivo .

In other words, to see assisted reproduction as exactly that, to produce children in all senses on - I was going to say on all fours.  I guess they come out on all fours with children naturally conceived.

And here the idea is - the fundamental idea is to prohibit attempts to conceive a child by any means other than the union of egg and sperm obtained directly from no more and no less than two adult human parents.

The various pieces of this, you know, the human child should have a human biological father, a human biological mother; that these ought not to be embryos or fetuses, but grown-ups who are the source; and that in a way, the second provision here could be captured under the first one, that you don't want children who are born as a result of fusing blastomeres from two or more embryos so that they might have four parents or in the other case with SCNT of having less.

PROF. GEORGE:  What I like about the first provision is that not only does it sort of stand on its own, but it solves a problem that we've had of being able to articulate a way that would probably be universally acceptable to ban cloning reproductive without having to deal with the other issue of research.

So it does that, which I think is, I hope, without creating any philosophical problems.

CHAIRMAN KASS:  Mike Gazzaniga.

DR. GAZZANIGA:  I guess this is my day.

CHAIRMAN KASS:  That's why you're here.

DR. GAZZANIGA:  This is the Murphy Brown provision here.  I know many women who are single moms who are artificially inseminated, and everybody is happy.  The children are beautiful, and the mother is happy.

This would preclude that, would it not?

CHAIRMAN KASS:  No.

MCHUGH:  No.

DR. GAZZANIGA:  Explain.  It says human parent.  There's not a parent around.  It sounds like it has to be -

CHAIRMAN KASS:  If the word "biological" were included in there would that satisfy?

DR. GAZZANIGA:  Two biological parents.

CHAIRMAN KASS:  Human progenitor, if we said progenitor.

DR. GAZZANIGA:  Yeah, but a parent makes it sound like you're excluding a whole -

CHAIRMAN KASS:  Progenitor was what I meant.

DR. GAZZANIGA:  Okay.

DR. KRAUTHAMMER:  I don't see how you can intuit that or maybe I'm missing something; that it would prevent artificial insemination?

CHAIRMAN KASS:  Mike thinks that "parent" might be interpreted to have a social meaning rather than the biological one.  That I think was the point.  It's certainly not intended.

DR. KRAUTHAMMER:  Two adult humans, right?  Does that do it?

CHAIRMAN KASS:  That's also fine.

DR. GAZZANIGA:  Two adult?

CHAIRMAN KASS:  Two adult humans.

DR. KRAUTHAMMER:  Two adult humans and that solves it, doesn't it?

DR. GAZZANIGA:  When does an adult start?

PROF. MEILANDER:  Whenever they produce the baby.

CHAIRMAN KASS:  Biologists -

DR. KRAUTHAMMER:  Aren't there regulations?  Mike, aren't there regulations at sperm banks?  There are regulations for adulthood, I'm sure, at sperm banks, right, or am I wrong?

DR. GAZZANIGA:  You get my point.

CHAIRMAN KASS:  Yeah, the point is clear.  No donation of sperm prior to the age at which they could be produced.

DR. KRAUTHAMMER:  That gets you into high school.

CHAIRMAN KASS:  Jim has to leave briefly, and I've sort of counted our fire drill break as against the normal break that we would take.  Are you going to leave pronto?

PROF. WILSON:  In about two minutes.

CHAIRMAN KASS:  When he gets up to leave, we'll take a break so that his time will be taken against our leisure.  We'll reconvene with a short break because we are, I think, rolling now.  We've still got a couple of things that are hard, but on this particular matter, Rebecca?

PROF. DRESSER:  Well, I wanted to say I'm not sure it's a problem in the bold provision, but in the preamble a fair number of children now have - one woman contributes the egg and one woman contributes the gestation, and so lots of people say they have two biological mothers.  They don't have two genetic mothers.

CHAIRMAN KASS:  So you want the word "genetic"?

PROF. DRESSER:  Well, I don't think you want this to say we want to prohibit that.

CHAIRMAN KASS:  Well, we're not, and we're not.  I think there are probably people around here who think that that's a bad idea, but we've left things.  In fact, surrogacy was, I believe, on the list before with full knowledge that within five minutes it would be off the list, partly because it's an established practice even though in some states it's outlawed.

PROF. DRESSER:  Right.

CHAIRMAN KASS:  But this was, again, an attempt to kind of get a bare bottom list that everybody could subscribe to.

PROF. DRESSER:  I guess a more general point though is in some ways so we're saying that exception we are not addressing, and then in the footnote it says we are not addressing ooplasm transfer, and then I wondered about this recent account of what went on in  China, which is, I guess, called nuclear transfer, not somatic cell nuclear transfer.

CHAIRMAN KASS:  Right.

PROF. DRESSER:  But nuclear transfer, and I was just reading the Times at lunch, and they have an editorial, and they refer to this as a hybrid embryo.

So hybrid egg, you know, as having two genetic mothers, and so I guess and it's similar to what I was wondering about earlier with the animal-human mixes and stem cells and blastocyst mixing or the chimeras there.  At what point do we say we don't mean to cover this exception, this exception, this exception?  You know, what's left?  I wonder about that here.

PROF. SANDEL:  Or what is the harm here that we're trying to avoid by this prohibition?  The specific harm, the no more and no less than two adult human parents?

CHAIRMAN KASS:  No, I put it the other way around.  What is the good that we're trying to defend?

The good that we're trying to defend, I think, was articulated in the early part of the document, right, which has to do with what it means to be born the fruit of two, knowing where you stand and who you're related to.

Now, there are, of course, all kinds of complications, both social and adoption and so on, but this repeats the point again that even in the case of adoption, one is somehow imitating the adoptive practice that which didn't succeed at first and which abandoned the child, and that one knows very powerfully how adopted children very often are terribly eager to discern their true natural roots, not all, but some, and there are even now efforts to open up the IVF registries with the donor, i which children want to be in touch with who it was that donated the sperm.

So that it ought not to be - I guess the point is just because it's possible to do all of these kinds of mixing in the laboratory, one shouldn't unnecessarily confound the attachments of the child who is blessed to be born by their means, and that seems a way of secure - we don't ordinarily think of the child when we think about people going to have the benefit of this technology.  We think about overcoming the infertility of the couple.

And this is a way of trying to secure for those children exactly the same kind of place in the world as they would have had had they been born by the so-called normal means.   That I think is the good that's being defended here.

And the other case, I mean, you could make an argument; you might make some kind of argument that, you know, what's the difference between donor sperm and sperm derived from stem cells?  We talked about this the other day.

On the other hand, if the little boy wants to know who my daddy is, you'll say, well, he was a six day old embryo donated from whom we extracted stem cells from which we produced sperm.

DR. KRAUTHAMMER:  One way to say it perhaps, Leon, is that you don't want to deliberately create orphans.

CHAIRMAN KASS:  Go ahead, Michael.

PROF. SANDEL:  I mean, I have a concern that has less to do with this particular technology than with the larger rationale that articulates the good, and though we're not focused mainly on the preamble, since you invoked it to explain the good at stake in this very highly specialized provision, I would like to address it, and it's on pages 3 and 5 that this comes out.

And the fundamental assumption there which I think is a view, but a highly controversial view is that biological origins are central to the identity of the child, whereas many would say, and I would be inclined to say, that the parents who raise and nurture the child are the primary source of the identity of the child.

The language here in page 3, "part of any child's identity as this child lies in its special relationship to two particular human someones from whom the child descends.  All of the child's being and identity it owes to a continuous developmental process that begins," and so on, "and continues through an unbroken sequence within the womb of the mother."

CHAIRMAN KASS:  That's a new point, Michael.

PROF. SANDEL:  All right.

CHAIRMAN KASS:  That's not a continuation.

PROF. SANDEL:  All right.  Well, let's then further down for the last paragraph on that page.

PROF. GEORGE:  Page 3?

PROF. SANDEL:  Page 3.  Talking about the singular relationship of parents to child and of child to parents central to the identity of each, of course, those are the relationships that are central to the identity, but the question here is the parents here whose relationship is central to the identity of the child, are they the biological parents, who in the case of IVF may be entirely unknown, or are they the actual parents who raise and nurture?

I would say the second, that when we're talking about the rights and the human attachments of children, which are, of course, uncontroversial, central, important, those rights and attachments have to do with having loving parents who nurtured them and raised them, not to do with knowing who the biological parents are who may have had nothing - who may only have produced those donor gametes.

And what this, on page 3 and then on page 5, what this suggests is that the identity of the child, the good that we need to protect with this provision here on page 12 is that the child's identity be bound up with its biological lineage rather than with its actual parents, the people who raise and nurture that child.

And I think I find that implausible, and if that's the good, if that's the good at stake, then there's no reason to prohibit this practice and yet not to prohibit IVF with anonymous donor gametes.  The moral distinction would have to rest on the distinction between orphaned gametes in the ES cell-derived ones and anonymous gametes in the case of the anonymous donor IVF kids.

DR. KRAUTHAMMER:  Well, I think that's right.  I mean, there may be an over emphasis on the biological connection that is being interpreted as being superior to the connection to the parents who raise you, but I think the point we want to make is there is a good in that biological  connection.  Forget about whether or not ways or it's a greater good or greater value than the one between, let's say, adoptive parents, but that it is in and of itself a good maintaining that connection.

And we see the truth of that in the fact that children who are adopted sometimes sense a need to find and make a connection with the biological parent. 

All that we're saying in that last provision is if you have a choice, you don't deliberately create an orphan by using a gamete from a fetus.  So that an anonymous parent is fine.  It's superior to having a nonexistent parent, and that I think is all that statement is saying, and I think you would agree with that, would you not?

PROF. SANDEL:  Why wouldn't you by the same logic either prohibit anonymous donor gametes in IVF or at least because you don't know where - if they're anonymous by definition, you don't realize the good of knowing where you stand with respect to your lineage, and why would -

DR. KRAUTHAMMER:  Well, actually that's not so because potentially you  could find that parent, and I don't think the prohibition - you'd want to prohibit that.  You might want to prohibit a situation in which the parent is inherently unknowable because he didn't really exist.

PROF. SANDEL:  Well, then why wouldn't you at least require that in any case of a non - why wouldn't you ban anonymous donor gametes in IVF clinics by saying by law, by congressional enactment, you have to provide a means for the child later if she wants to track down the owners of the gametes that were donated to the IVF clinic if the human good of knowing your lineage is so significant.

DR. KRAUTHAMMER:  All I'm saying, I don't - you have to say it's an absolute value to come up with your prohibition, and I don't believe it's an absolute value.

PROF. SANDEL:  We're prohibiting it here.

DR. KRAUTHAMMER:  Well, then I think I would alter that text to take away that implication.  I don't think it's absolute, but it is a value, and that's why I think it has an application in the case of the nonexistent parent and the deliberate creation of an orphan.

PROF. SANDEL:  Well, it's only an orphan if there are no parents to raise it.  It's biologically -

DR. KRAUTHAMMER:  Biologically, I mean.

PROF. SANDEL:  But then if - it's not an orphan if it has parents.

DR. KRAUTHAMMER:  It's a biological orphan, and it's -

PROF. SANDEL:  Biological orphan.

DR. KRAUTHAMMER:  - deliberately chosen to be biologically orphaned if you have no parent, and I think that would be a reasonable thing to want to prohibit.

CHAIRMAN KASS:  Gil.

PROF. MEILAENDER:  I  have no brief at all in favor of anonymity of donated gametes.  I have no brief in favor of donated gametes actually, period, but I still think that's a slightly different question at work.

One of the things that adoptive parents - and they are parents - one of the things that adopting parents will inevitably have to take account of in raising their child in a way that other parents do not, is that that child is genetically the product of other people and that this will make a difference in all sorts of ways.

It will make a difference in health ways.  It may make a difference in some very complicated psychological ways, and although they know themselves to be that child's parents, because I do think at some point rearing just trumps gametes, they also know if they're at all serious that they won't be able to ignore that other factor; that part of rearing that child will involve taking account of it.

So it's not an either/or, it seems to me.  They're going to have to take account of it, and I would, therefore, assume that, you know, this prohibition or something like it if we put it into this context now is saying here's one thing that we should never want adoptive parents to have to take account of, namely, that the child of whom they are now the parents was conceived as the product of more than two or less than one gamete.

I mean, we're saying there may be other things we wouldn't want them to, but here's one thing that we wouldn't want them to think about, that the conception of this child was produced, you know, from the embryo on up in that way.  That's the way I would understand this in relation to your concern.

CHAIRMAN KASS:  Go ahead.

PROF. SANDEL:  First, I should say I have no objection to this prohibition if the period were placed after "egg and sperm," "prohibit attempts to conceive a child by means other than the union of egg and sperm."  That I think is fine.

The add this other is to add something that actually currently doesn't even exist, though it exists in mice.  There is no existing practice of deriving gametes from human embryonic stem cells.  So we're anticipating this is a possibility.  It's a fairly arcane topic.

CHAIRMAN KASS:  I don't think it's arcane, Michael.

PROF. SANDEL:  Well, if it's likely on the horizon, enough so for Congress - now, here this gets back to the distinction between a regulatory body and Congress, what we're saying here is if it were the mere prohibition of conceiving a child by means other than union of egg and sperm, I would have no problem saying Congress should enact a prohibition on that.

If we were to add this other thing, which we worry about because there can now be derived from mice, gametes derived from mice embryonic cells and we fear that in the future that may be done with human beings, then that's the kind of thing it seems to me, all right, maybe there should be a presumption against it for the kinds of reasons that Leon and Charles point out, and that's what the regulatory body should take into account.

My question for Gil is - so that's really a question of the first half of this is fine for congressional ban because it's straightforward and clear and it amounts to banning reproductive cloning.

The second is highly technical.  It's to some extent speculative, and morally speaking, the moral good that this partly speculative prohibition vindicates is also a good that is called into question by anonymous donor gametes in IVF, which, Gil, I assume you would be prepared to prohibit that, too, in the name of that good, insofar as that good is regulative and important.

PROF. MEILAENDER:  Just a word in reply.  I already said I would, yes.  The point would be I think here that if we're talking about sort of proposals for interim measures that would place barriers in the way of people transgressing boundaries not yet transgressed, that other boundary, alas, from my angle, alas, is already well transgressed, and therefore, if we want to stop it, it wouldn't be in the context of setting some roadblocks in the way of, you know, possible things on the horizon.  It would have to come in another way.

PROF. SANDEL:  No, I have a deal for you, Gil.  I would empower this regulatory agency to consider the anonymous donor gametes in the case of IVF along with this one.  Why not?

PROF. MEILAENDER:  I have a deal for you.  You set up the legislation in such a way that I appoint the membership of the regulatory body, and we'll go on it.

(Laughter.)

CHAIRMAN KASS:  Michael, I think Gil's point especially elaborating the general question about taboos, as Bill May so beautifully put it, is it seems to me on the money, and the tactic of saying that - see, it's very interesting.  I mean, this is an absolutely marvelous example of the corrosive effects of the slippery slope form of reasoning.

The point of departure of this text was natural procreation and the things we owe children in the ordinary sense.  We don't produce children for adoption.  The need for adoption of children is a sad fact, and thank God there are people around to rescue them.

There are now all kinds of new ways of doing things here and not everything that is questionable is necessarily fit for legislative proscription, and you take as a point of departure for the analysis the perfectly accepted practice now of AID, insist that anybody who wants to bar the further development really ought to at the same time be calling for the legislative ban on that; whereas we're starting really here for trying to make sure that there aren't further departures at least until such time as there is good reason to cross those new boundaries.

And so it seems to me rather than from the point of view of philosophical principles starting from the middle of the slippery slope, begin with the kind of statesman-like view and say what can we do now to hold the line here at least until such time as we can deliberate this further.

PROF. SANDEL:  Well, that's unfair in one respect.  I'm prepared to push back on the slippery slope, provided we have this regulatory body to deliberate about that, push it back maybe to the terrain that Gil worries about.  I wouldn't foreclose that.

DR. KRAUTHAMMER:  But, Michael, wasn't the reason for establishing the regulatory body that it would have expertise that we don't have on the possible scientific goods that would be yielded by certain kinds of experimentation?

But here we're not discussing developing a fetus for experimentation.  This is explicitly for the purpose of conceiving a child.  So I don't know what the expertise of these regulators is going to be that will be superior to ours in judging as to whether or not a child of this kind ought to be created in the first place.

It's not a scientific issue.  It doesn't require any scientific knowledge.

PROF. SANDEL:  So that means for research purposes you could try to create embryos obtained from more or fewer than two adult human parents.  You simply couldn't try to co