Meeting Transcript
September 5, 2003

Wyndham Washington Hotel
1400 M Street, N.W.
Washington, D.C.

COUNCIL MEMBERS PRESENT

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

Elizabeth Blackburn, Ph.D.
University of California, San Francisco

Rebecca S. Dresser, J.D.
Washington University School of Law

Daniel W. Foster, M.D.
University of Texas, Southwestern Medical School

Francis Fukuyama, Ph.D.
Johns Hopkins University

Michael S. Gazzaniga, Ph.D.
Dartmouth College

Robert P. George, D.Phil., J.D.
Princeton University

Mary Ann Glendon, J.D., L.LM.
Harvard University

Alfonso Gómez-Lobo, Ph.D.
Georgetown University

William B. Hurlbut, M.D.
Stanford University

William F. May, Ph.D.
Southern Methodist University

Paul McHugh, M.D.
Johns Hopkins Hospital

Gilbert C. Meilaender, Ph.D.
Valparaiso University

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

Michael J. Sandel, D.Phil.
Harvard University

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

SESSION 5:  BIOTECHNOLOGY & PUBLIC POLICY: PROPOSED INTERIM RECOMMENDATIONS, I

CHAIRMAN KASS:   Good morning.  The two sessions this morning return to our project on "Biotechnology & Public Policy," touching the beginnings of human life, and we have as the text for the discussion the staff working paper at Tab 17, draft recommendations.

Let me try to set the background for this so that we're all on the same page, and I'll read just a bit from the beginning of the working paper.

"Over the past 20 months, the Council has devoted much time and energy to examining the current governance of the uses of biotechnologies that touch the beginnings of human life, practices arising at the intersection of assisted reproduction, genetic screening, and human embryo research.  We heard from various experts and stakeholders, and then we engaged in our own comprehensive diagnosis of the current regulatory mechanisms and institutions in a paper prepared by Carter Snead and reviewed at the June meeting."

That was the very long document.  We've had many comments from all of you, and that document is in the process of being revised and improved, and many thanks to you for that.

Then at the July meeting, we discussed two shorter papers, one called "The Findings," which summarized the results of the diagnosis, and there were some small comments on how to phrase those, but by and large, there was general agreement that we had those things down right.

Then there was a paper called "Policy Options" in which we looked at various general and specific policy options, and I think the conclusion with respect to the larger picture was that although we understand a great deal about the current regulatory landscape and we've identified various kinds of concerns that suggest the need for improved monitoring, oversight, and perhaps new forms of government regulation, we're very far from being able to offer any kind of clear or well-considered recommendations regarding any major institutional reforms and identify there a whole number of things about which we are ignorant.  And without answers to the questions in these areas of our ignorance, it would be premature, at best, to offer any dramatic legal or institutional changes.

And everybody understood that there was further research and inquiry needed and consultation with all of the relevant actors before anything further could be done.

Nevertheless, that second paper on "Policy Options" was introduced also for the specific purpose, secondary specific purpose, to begin a discussion about what specific actions or policies, if any, the Council might recommend as interim measures in this area, while the discussion about regulation continued.

It was clear that there are on substantive, as well as institutional questions, major disagreements amongst us, as there are in the country as a whole.  But it was thought that there might be matters where nearly everyone is in agreement about the need either for more information or for more oversight or perhaps even for some specific reforms or actions.

And using the discussion of the document and seeing where the agreements were, the staff was authorized to prepare a document of possible draft recommendations that might be things that the Council could recommend more or less with one voice, not setting aside the differences that exist amongst us - those differences will continue to exist - but notwithstanding those differences, to find whether we could agree on several policy suggestions that we think should command not only the respect, but perhaps even the assent of most people of common sense, goodwill, and a public spirited concern for freedom and dignity.

And, therefore, the document that you have before you, two parts of which, two of the three parts of which reflect that discussion, and let me simply turn pages with you, and then the proposal will be that we take the first session on the things that we have, in a way, talked about before to see whether these recommendations reflect a kind of consensus of the group.

And then in the second session, we'll return to the things in Part III about which we have not yet had prior discussion.

The recommendations that grow out of the previous discussion are under two major headings.  One suggestion is for federal studies, data collection, reporting, and monitoring regarding the uses and effects of these technologies, beginning on page 3, and they comprise basically four items:

One, to undertake federally funded longitudinal study in the health and development impacts of ARTs on children born with their aid;

Second, federally funded studies on the impacts of ARTs on women;

Third, federally funded comprehensive studies on the uses and effects of reproductive genetic technologies; and

Four, suggestions for strengthening and augmenting the one piece of federal legislation in this area, the Fertility Clinic Success Rate and Certification Act.

And those recommendations are numerous, but they are in two parts, one to enhance the reporting requirements, which would be useful for consumer protection, on the one hand, and for federal government information gathering and monitoring, on the other; and, second, beginning over on page 8, recommendations to enhance patient protections.  We'll go through these things one by one as we proceed.

The second set of recommendations recognized that for the most part professional oversight is the principal mode of regulation for the practice of medicine, and while the industry and the profession have made great efforts to set guidelines and standards for the clinical practice of assisted reproduction, the Council suggests that there are certain areas, substantive areas, that might require attention and improvement.  And we list six of them as recommendations for improving professional self-scrutiny.

Part III I want to leave for the second discussion.

So I think the best way to proceed would be to simply take these section by section unless somebody would like to begin with some general remarks of clarification about what we're doing or why.  Maybe a couple further sentences would help.

As we currently see this particular document, the bulk of it will be this diagnostic paper suitably improved so that the major contribution will be to make clear where we stand at the moment in the various forms of oversight monitoring and regulation.

Then we will have the summary findings, suitably improved, and then if the Council will agree, some interim recommendations.  Don't forget this is an area in which there is, as we have identified, there are certain kinds of concerns that are being unaddressed, and there are certain areas of ignorance.

And while one calls for further discussion of what might happen to improve the regulatory institutions, in the meantime we need certain kinds of things to happen before we could even intelligently discuss those things.

So if there are recommendations that we can agree on, and I certainly hope there will be, that would be the third and final part of such a document.  And the goal is to try to have this ready for November.

General comments?  If there aren't general comments, then I suggest we sort of proceed section by section.  Does someone want to?

Are we all right?  Mike.

DR. GAZZANIGA:   Just to place this endeavor in some kind of context, as we've said before certainly informally - I don't know if we've said it formally at Council - we recognize the fact that medicine is largely unregulated, and the kinds of issues that are coming up here for better outcome studies, tracking of the success and failures of particular medical procedures is a desire or wish that one could have for literally dozens, if not hundreds of medical procedures that are commonly ongoing currently in medical practice.

And I think it would be helpful to recognize that fact maybe in a little more extended way and to say that - to recognize that fact because I don't think that fact is generally understood by the American public and to say that the reason there's attention given to this particular endeavor is because this is the one that we are being asked to consider.

And to try to take off the table that we are bullying sort of on one point to the exclusion of others.

CHAIRMAN KASS:   No.  Thank you.

And I think there was conversation on this subject last time as to why single this area out, and I think there were - I remember the answer.  Many of you spoke, but I'm immediately remembering Rebecca's question.  Mary Ann's answer was partly that this is the topic that we've chosen.  It's partly that there are - I think Jim Wilson's comment - that there are actually children who are produced here.  It's one of the few areas of medical treatment which result in the production of other human beings who are the outcome of the practices, and the outcomes with respect to them so far have been relatively neglected as a formal matter.

But I think your point is well taken, and I think there's a way to very early on indicate why we're doing this at all, and what the limitations and implications are of setting these recommendations.

Mary Ann?

PROF. GLENDON: Are you ready to move on?

CHAIRMAN KASS:   I am unless somebody else wants a general comment.  Rebecca.

PROF. DRESSER:   I was just going to mention that there is a difference in that federal funding hasn't been very available for studies in this area.  So I think that's one reason to urge this, and I think it will welcomed.  That part of it will be welcomed by the medical and research community in the ART area because I think they've really wanted to do some of these things, and they haven't been able to get the money.

CHAIRMAN KASS:   Any general comments?

If not, let's proceed and let's take it section by section.  Line editing, please, after the meeting.  I think what one wants to look at is just the particular recommendations unless there's something egregious in the justifications.

Mary Ann, would you like to start?

PROF. GLENDON: Yes.  Well, my comment is on Part C of Section I on page 4.  It's related to this question of why are we focusing on certain areas at this time.  There are some areas where technology has gone way ahead of the general understanding of what is happening in practice, and I think I see here a statement that differs from what I read in previous documents on this topic of pre-implantation genetic diagnosis and gamete sorting.

It says here, "Before these practices become routine."  Am I mistaken or are we not already in a situation where pre-implantation genetic diagnosis is a normal part of prenatal care?

CHAIRMAN KASS:   Not quite, right?  I think we've been previously told that there are probably about 2,000 babies born worldwide with this.  That's an under estimate, as I learned since the last meeting.  If you speak to some of the practitioners, the numbers are much higher, but not much.  The range is probably maybe 10,000 worldwide.

This is not part of routine care.  There are relatively few clinics doing it.  There are no advanced studies, no prospective studies about the effects.  It is somehow moving very rapidly into not general, routine clinical practice, but accessible as an adjunct to clinical practice.  It's still very expensive.  Is that correct?

Maybe we need a procedural suggestion.  Shall we take them one at a time rather than hop around?

Are there any discussions of the first recommendation?  Janet, please.

DR. ROWLEY: I brought this up last evening, but I am concerned that if we only recommend prospective studies, which is what's recommended at the bottom of page 3, it's going to be quite a while before we get any data, and I think that it would be helpful to have some kind of study mounted to the extent that it's possible of what the situation is right at the present time for at least some of the children who are born with ART.

I'm very well aware of all of the problems of privacy that will make it difficult to have it be a complete study.  This may actually be a reason why the study should be done outside the United States, where gathering longitudinal data is far easier than it is in our country.

But I think that having some sense of what the present situation is would be very helpful because with the prospective studies the data are probably going to be coming available five years if you're very lucky once the study starts and more likely ten years.  And I think that that's not a helpful situation.

CHAIRMAN KASS:   Does someone want to join in on that?  Please, Mike.

DR. GAZZANIGA:   That's completely correct, and the other complicating factor is that ART itself is an evolving medical procedure that is being improved on a yearly basis.  So that the study that you might start next year in ten years' time will yield you a picture that won't have anything to do with the current then being practiced ART technologies.

So it becomes a very difficult interpretive procedure, and it's a moving target all the time, and it becomes very difficult to evaluate the meaning of it.

CHAIRMAN KASS:   More difficult than the changing technologies for valve replacement or other things that happen in medicine?  I think -

DR. GAZZANIGA:   I wouldn't know because you don't know.

CHAIRMAN KASS:   I'm sorry?

DR. GAZZANIGA:   I don't know what the advances will be.  So -

CHAIRMAN KASS:   Well, but I mean, medicine is a moving target, but people do -

DR. GAZZANIGA:   Yeah.  No, the problem is the same.

CHAIRMAN KASS:   The problem is, in a way, similar.  I mean, we note here that there is a collaborative study underway right now reviewing the entire existing literature on the question of the results.  The Center for Genetics and Public Policy, in collaboration with the pediatricians and the ASRM, are doing this study now, and - I'm sorry?

DR. ROWLEY: It's my impression that that's only of published literature.

CHAIRMAN KASS:   That is a study of published literature.

DR. ROWLEY: No.  So it's different.

CHAIRMAN KASS:   But the difficulty in the United State of finding the population to study when the origins in assisted reproduction technology is a matter of privacy, you can't find the population to study.

Whereas, we have, I mean, if it gets going, this study of 100,000 children that is to be underway, and it's relatively easy to include the data there about the origin of the child, and since you follow them, you follow their health and developmental features in the process.

Now, whether that study would accept this recommendation to add these considerations to their protocol because everybody else is clamoring to get in there I don't know, but that is a ready made instrument for doing something prospective if one thinks it's worth doing.

You're not suggesting, Janet, that we should look only at current data rather than the prospective.  You're suggesting something in addition.

DR. ROWLEY: I think that's in addition, but this would be a way.  Again, if you go to countries that have better organized health care than we do, which is much of the rest of the Western world, you can probably get these data fairly easily, and I'm sure that there would be people there who would be willing to cooperate.  I suspect that some of the data are already more or less in hand, and that that would be a surrogate for a prospective study, but at least it could bring to light of the current practices what are the results, and are there some practices which, in fact, do lead to an increased frequency of children with congenital malformations or some other problems; that it would be well to alert the world, again, worldwide to these problems.

CHAIRMAN KASS:   Thank you.

Frank.

PROF. FUKUYAMA:   Does somebody know the nature of legal constraints in terms of commitments on privacy that would bar, you know, a retrospective study in this country?

I mean, because I'm sure with enough money you could track down a lot of these people, but there may be other obstacles to doing that as well.

CHAIRMAN KASS:   I don't know.  Dan, do you know?

DR. FOSTER:   Well, you know, the HIPAA regulations that have cost millions to get in are very restrictive.  I don't know how they would apply in terms of retrospective study of this sort, but I mean, you  know, at one point they were so restrictive that you could not call out a patient's name in the waiting room to come in to see the doctor.  I mean they were that rigid.

And they've now said that doctors can communicate using the name of a patient with a consultant, and so forth.  I have no idea about the impact on a research thing.  It certainly has changed the way one practices medicine in hospitals and clinics and so forth and has gone overboard in most people's view about, you know, protecting privacy.

But I don't have any idea.  Janet may.  I don't have any idea of how that would apply to a retrospective study.  You know, I don't know.

CHAIRMAN KASS:   Rebecca, I think, knows something about this.   Yes?

PROF. DRESSER:   There are exceptions in contacting people through physicians.  There are ways it can be done.  It's just more costly.

But I don't see a problem.  I think we should endorse something like we encourage other studies to gather data in the interim or other scientifically acceptable studies.  I mean, in general in research you run into similar problems, and so you try to figure out different approaches to get data and then put them all together eventually, but it seems to me we should be open to other forms of research.

CHAIRMAN KASS:   Still on this point?

DR. FOSTER:   I just want to ask one question.  Janet, do you think that the - you talked about the fact that other systems have much more recorded data.  Do you think that the NIH, let's say, for example, would fund a study that was basically in the U.K. or something of that sort?  Is there a precedent for that?

DR. ROWLEY: Well, there certainly is a precedent in breast cancer.  Many of the studies in Italy on treatment for breast cancer were funded by MCI, and so I think that that wouldn't be a problem.

DR. McHUGH:   In fact, Dan, as you know, the major psychiatric studies in genetics, the schizophrenia studies and all were done out of the birth registries in Sweden and Denmark and supported by the NIH.

CHAIRMAN KASS:   Well, you know, I think we've heard from people in the industry that they're not averse to such studies.  The problem is paying for it, and this would seem to be a way of making it feasible for them actually to go ahead and collect the data.

Jim.

PROF. WILSON:   I have no objection to acknowledging other methods of research, but I think the advantages of a prospective study are extremely powerful, and in the field which I study, which is happily alien to this group, criminal justice, prospective studies have largely revolutionized our understanding of what is happening because in a prospective study, you self-sample selection bias presumably, and you are discovering things that do not depend on the memory of people who may or may not recall what happened to them in the past.

Not everything is written down, especially in criminal justice, probably also in medicine.  So that I would not want the draft to lose the emphasis, perhaps not the exclusive emphasis, but the emphasis on prospective studies.

CHAIRMAN KASS:   Mike.

DR. GAZZANIGA:   This particular study that you want to hook up to -

CHAIRMAN KASS:   Right.

DR. GAZZANIGA:   - is well known, and it's very complex.  It's huge, and it is guarded with respect to what particular new patient group will be followed because if you admit a new one, the statistical implications of that are huge for the overall study.

And there's a man in charge of that, I don't know if you've had a chance to talk with Don Mattison, but he's the head of that study at NICHD, and I'd highly recommend that the staff or you actually sit down and consult with him what the implications would be for this.

And finally just to point out that apparently I have a colleague that's on this committee.  The implications, of course, and the difficulty of getting compliance, getting follow-up is huge, and that's another factor that influences whether they're going to take on yet another charge.

So I think this could be tightened or it could be more specific if you had that conversation.

CHAIRMAN KASS:   Right.  We have started to speak them, and the proposal is not that they add ART patients specially.  That would be biasing the sample, but roughly one percent at the moment, may be climbing, roughly one percent of births in the United States are ART births, maybe slightly higher.  And that means of 100,000, you've got 1,000 children.

Now that's not a big population, but that's much bigger than any study that anybody has looked at up to this point, and if you could get data for 1,000 kids to monitor over a period of time, you'd learn something.

We have started conversations with them.  I didn't want to have further conversations with them until such time as this Council said this was a good idea, but if you think this is a good enough idea at least to run this under their nose and say, "This is what we're thinking about recommending.  Are there ways to fix this?"

And you should also know that I believe that there is likely to be some legislation introduced into Congress.  We just came upon this information - recommending a similar kind of study, massive study, a prospective study of this sort.  So there might be some support for this.

Elizabeth.

PROF. BLACKBURN:   What I'm hearing is that it sounds as though although in the way Section A is written we've come to a conclusion that has converged on this particular study, it rather strongly says ideal vehicle.  Maybe we should phrase it in such a way that we think that there are, you know -

CHAIRMAN KASS:   Okay.

PROF. BLACKBURN:   - it sounded as though we had done all of our homework and ended up with this very specific case.

CHAIRMAN KASS:   Good.

DR. FOSTER:   We couldn't hear you.

PROF. BLACKBURN:   I was instructed I wasn't supposed to speak close to the microphone.

(Laughter.)

PROF. BLACKBURN:   It was also turned on, wasn't it?  Yes.

So the way we phrased Part A of the sections here was as though we had converged upon this one particular study, the instrument, as the way to do it, and it implied that perhaps we had considered more studies than we have.

So I was just suggesting we don't put it quite that way.

CHAIRMAN KASS:   It goes to the language "ideal vehicle" on top of page 4, and Elizabeth is dead right.  We'll fix that.

Next item.  Are we okay on this?  "Federally funded study on the impacts of ARTs on women."

DR. GAZZANIGA:   I'm not aware.  Is there a body of data here that there's a problem?

CHAIRMAN KASS:   Yeah, ignorance.  There is no data on the question of the effects of super-ovulation, repeated cycles.  This was, I think, in the original diagnostic document that there were a number of areas of ignorance, and at the very least no one is suggesting one clamp down on the practice, but women who are undertaking these activities, it seems to me have a right to know what the various hazards are, and as Rebecca points out, it's precisely because there hasn't been the availability of funding, or at least that's one of the reasons.

No one has gone out to get the information.  This is an area of interest to you, I think.

PROF. DRESSER:   Yeah, I think there have been some concerns raised about higher cancer rates later in life, but there are no good, solid data.  It has been discussed in the literature.  So that's one example of some medical indications that there could be problems, but no solid research.

CHAIRMAN KASS:   Number 3.  By the way, if things occur to anybody when they go home that we haven't considered, we can consider them if you send them in, and if they're not of the line editing sort, but if they're arguments about something, send them to everybody so that we'll know where we are.

Item 3, Item C, federally funded comprehensive studies on the uses and effects of reproductive genetic technologies.  This has to do really with the fact that it's not so much the existing practice, but the introduction to existing practice of some of these new adjunct technologies involving, in part, sex selection through gamete sorting, in part, PGD.

And the question is whether one should begin to, with the participation of the industry and the profession, to study how these practices are developing, the reasons that they're being used, et cetera, and to develop some kind of mechanisms in advance for monitoring these outcomes so that one is not simply in the position of retrospectively trying to see what happens when an innovative procedure is added to an already unstudied area.

I think that's the not very well put justification for this.

DR. ROWLEY: Let me just add I think that it's important to recognize that the community of ART is relatively small and that if it became apparent through discussions and meetings that a particular aspect of, say, prenatal diagnosis led to especially bad outcomes, that this information is going to be fairly rapidly and fairly widely known.  So that people are not going to persist in doing something that's going to lead to a high incidence of affected children.

Now, we've emphasized that there is a disconnect between having a woman become pregnant and knowing the results of that pregnancy nine months later, and I think that that disconnect is certainly something that we should try to diminish so that the actual results are known.

But the women who are undergoing this are, in general, reasonably sophisticated, and it seems to me that many of them would be contacting not only their physician, but the clinic if they had an untoward effect.

So I think that we are ignorant, and that is certainly something that should be corrected, but it would be my impression that to think that there are really horrendous, bad effects out there that nobody knows about is unlikely.

CHAIRMAN KASS:   Well, let me ask you this.  If someone proposes to you that we start doing - put this a few years back - we start doing blastomere biopsy of, say, an eight cell embryo and we remove one or two blastomeres for biopsy and screening, and you're on the IRB of your institution.  Wouldn't you at least request that some kind of provision for follow-up and not just a term but over a longer period of time be developed so that you know whether or not what looks relatively harmless turns out, in fact, to be harmless?

In other words, here is a novel diagnostic procedure.  Maybe it's harmless; maybe it's not harmless, but I certainly in the absence of the data wouldn't simply assume that it's fine and that subtle changes will be simply recognized and correlated with this original intervention.  I mean, it would seem to me ordinary medical prudence in an ordinary field would say let's make sure we watch this and we put in place at least means of gathering data and monitoring this rather than have it appear anecdotally in this clinic or that.

DR. ROWLEY: Well, ideally that's the way it should be, and that's why to the extent that we can have less of a disconnect between the individuals actually performing the procedures and the obstetrician delivering the baby and the pediatrician monitoring that baby, that would certainly be a far better system than we have now, and has been reiterated.

There's no money available to ART clinics to perform that kind of follow-up, and so that's where we're recommending that.  I think that is fine because this is a departure from everything that has been available in this area until the present time.

And we occasionally use italics in our reports for emphasis.  I certainly think that the top of page 5, to enable the federal government surveillance to gather information, that should be italics and bold because this is not something that has been done before, and we are now paying the price in terms of ignorance of not being willing to fund studies like this.

CHAIRMAN KASS:   Bill Hurlbut.

DR. HURLBUT:   Just to emphasize your point, Leon, it's not just the dramatic, new types of technologies like PGD.  It's the ongoing revisions in the culture medium in which the embryos are nourished.  It's changes in issues like when the embryo is going to be implanted. 

For example, with blastocyst transfer, which was instituted some years ago, it has slowly become apparent that there's an increase in the number of twins.  In fact, all the way across with IVF, as you delay longer to implant the embryo you get an increased rate of twinning.  It's interesting also you get an increased rate of male offspring if you wait until later putting the embryo into the womb.

So all of these things suggest that even subtle changes in the current practices beyond some dramatic innovations deserve to be monitored.

CHAIRMAN KASS:   Can we turn to the fourth?  This is, just to repeat, the Fertility Clinic Success Rate and Certification Act is the one piece of federal legislation at the moment that affects this field, and there are suggestions here both to improve the original function of consumer protection and, as Janet has emphasized, to enable the government to gather information and monitor the development, uses and effects of the technologies and practices in this area.

And then we made some specific recommendations both for enhancing the reporting requirements and for enhancing patient protections.

Any comments?  Let's just go in order.  Any comments on any of the items under Item 1?  Gil.

PROF. MEILAENDER:   This is just a question, something that I don't know, and I can't recall that we talked about it when we talked about the longer paper that was just findings about what was going on.

But with respect to A, about including patients as a measure rather than just cycles, what I found myself wondering is why wasn't that done originally.   Is there some reason that cycles was preferred, some reason that we ought to know about.  It seems like sort of an obvious measure.  Was it just happenstance?  Do we know anything about that?

CHAIRMAN KASS:   I'm tempted to take advantage of the presence of Sean Tipton, who probably knows the answer.

Would you mind if you do know the answer?

MR. TIPTON:   Yeah, it essentially was two things.  One was largely at the behest of the CDC statistician.  So you probably ought to talk to them.  They seem to prefer that as a metric because it was a cleaner measure, and they thought it would be a more meaningful measure of efficacy of the procedure to look at it by cycle rather than by patient.

CHAIRMAN KASS:   Thank you.

PROF. BLACKBURN:   Related to that point.

CHAIRMAN KASS:   Elizabeth, please.

PROF. BLACKBURN:   Is this the place to also introduce the other parameter of how many multiple or twin births result?

I know we deal with that as a separate section later on, but it seems as if it's another statistic.

CHAIRMAN KASS:    You know, I think -

PROF. BLACKBURN:   Which is relevant.

MR. TIPTON:   That's in there.  That's reported now.

CHAIRMAN KASS:   That's now reported.

MR. TIPTON:   Yes.

CHAIRMAN KASS:   Yeah.

PROF. BLACKBURN:   Okay.  Thank you.

CHAIRMAN KASS:   Anything else on Items A, B, the reporting of risks and of adverse effects, costs?

This might be controversial to have the clinics report on the creation, use, and disposition of the embryos and the procedures that are followed clinic by clinic so that people know what's what.  This is not an attempt to police the practice, but simply to inform ourselves so that one didn't have to wait until this RAND study to simply know the answer to some of these questions.

DR. GAZZANIGA:   It has to recognize that that doesn't have any medical value.

CHAIRMAN KASS:   No, but as I say, this area was defined as the conjunction of assisted reproduction, genetic screening and human embryo research.  Alas, those things are related, and if one wants to simply have knowledge or oversight of what's going on here, that's relevant information.

DR. GAZZANIGA:   In what sense?  How is it relevant?

CHAIRMAN KASS:   Frank?

PROF. FUKUYAMA:   Well, just on this point, you know, Michael has been making the case for the last year and a half about the intermediate moral status of embryos, which means that even if you don't consider them as the equivalent of an infant, they are not just another clump of cells, and with other - I mean, in the last meeting, you know, I made the analogy with cadavers.  I mean, you're not free to simply dispose of cadavers and, in general, with things to which you attribute moral status.  You know, the market is not simply free to dispose of them.

And the government has some role in keeping track of them and, you know, making sure that people don't treat them simply as waste products or that sort of thing.

So I think that's the primary motive for this kind of reporting, but you're right.  It probably doesn't have a medical function

CHAIRMAN KASS:   Michael, did you want to comment?

PROF. SANDEL:   I agree with what Frank has said.  I can say more if Michael wants to pursue the issue, but if he's satisfied by that answer, we can move on.

CHAIRMAN KASS:   Mike?

Alfonso.

DR. GóMEZ-LOBO:  To remark on that, that's one of the reasons why I'm interested in a full blown discussion of the intermediate position.  I personally continue to think that it's a contradictory notion, but I'd just like to add the following:  that, for instance, Germany has severe restrictions on the cryopreservation of embryos, and I think it has to do with their constitution and with their legal system in general.

I wanted just to bring that up as a remark.  In other words, I think it's perfectly appropriate at some point to pass some kind of moral judgment on cryopreservation on such a massive scale as it's being practiced at present in this country.

CHAIRMAN KASS:   But you couldn't reach that policy question or moral discussion unless you knew the facts, and this was simply an attempt to get the facts.

DR. GóMEZ-LOBO:  That's right.  That's right.

CHAIRMAN KASS:   Anything further on Item E or F?

DR. GAZZANIGA:   I have a question, too.

CHAIRMAN KASS:   Mike, please.

DR. GAZZANIGA:   Do privacy issues come up under F?  It's none of your business why I want to do it?

I mean, why can't a patient's response - and I'm just not familiar enough with this.

CHAIRMAN KASS:   Oh, well, how shall I put it?  Take the case of ICSI, intracytoplasmic sperm injection, originally introduced for male factor infertility.  Yet in the CDC data reported for the year 2000 used in 46 percent of all IVF cycles and of 40 percent of those instances no male factor infertility.  Some anecdotal but not yet studied question as to whether there aren't some kinds of additional risks connected with this.  It's still a rather young procedure.

The batting average, the success rate with ICSI is higher.  Therefore, it seems to me people should know what are the indications of a possibly greater, more risky procedure, a possibly higher chance of success.  As a matter of consumer protection, that kind of information should be known.  It's not a question of trying to stop this, but you'd like to know why are people doing this.  What are the indications?

And I think that's again, just sort of good, standard reporting practice, especially of novel procedures which carry an as yet unknown risk.  It's not meant to prevent people from doing this.  It's meant to inform them as well as possible of the benefits and possible risks of proceeding on the basis of good scientific data.

Rebecca.

PROF. DRESSER:   Michael, did you say you were concerned about privacy?  I mean this wouldn't be identifiable.  It would be just reported without anybody's name or information.  So I don't think it would present that issue.

CHAIRMAN KASS:   Did I understand?  I thought Mike was suggesting that this was a private decision.  People can make up their - yeah.

PROF. DRESSER:   Well, yeah.

CHAIRMAN KASS:   And no one is saying it shouldn't be a private decision.  It's just it should be a more informed private decision, I think.

All right.  Then a couple of things on enhancing patient protection.  This has to do with the question of how you report, the measures of reporting, and there's been some suggestion - we talked about this before - that if you're primarily focusing on the success rate, there's a natural reason to want to improve that success rate, and there might create a certain kind of perverse incentive to increase the number of embryos transferred leading to an increased incidence of multiple gestations, and there the bad effects on the children are well known.

And then we heard from some of the people who came from the patient groups being concerned about what are sometimes called informed consent matters, but with Rebecca's help we're adopting the language of informed decision making, not just the matter of consenting.

And there was some request to us that the act might, in fact, present a kind of model consent form and some kind of safeguards.

I take it from the relative silence that these things seem relatively uncontroversial, I mean, sort of common sensical matters. Am I wrong?

If we come to the implementation, the question of enforcement, right now the only penalty that the act provides is if one of the clinics refuses to  comply by submitting the data, they publish their names, and we don't know what further measures should be taken, but that seems if these are really important things for us to know, there ought to be a certain kind of improved means of obtaining compliance from the various clinics.

And then the last -

DR. GAZZANIGA:   How many reported?

CHAIRMAN KASS:   I think it's between five and ten percent.  Am I right, the people nonreporting?

MR. TIPTON:   Yeah, there's almost 400 clinics that report, and there are about 25 or 30; is that about right, Eleanor?  That are listed as non-reporters, and what you don't know for sure is if they are continuing to practice.  So some of those are ones who have reported in the past and are no longer reporting because they've shut down.

We estimate that about 98 percent of the cycles are done in SART member clinics, which by definition means they report.

CHAIRMAN KASS:   Thank you.

DR. GAZZANIGA:   So the system is working.

CHAIRMAN KASS:   I'm sorry?

DR. GAZZANIGA:   The system is working, the current system.

CHAIRMAN KASS:   Mostly working, yeah, and maybe that's -

DR. GAZZANIGA:   I mean public humiliation is strong.

CHAIRMAN KASS:   Sufficient control.

Well, let's get some information on this.  I'm not convinced that the stigma of having one's name published is a sufficient deterrent to practice.  If those clinics have not shut down, that's proof, but let's get the data, and if you can help us out on that after the meeting.

PROF. SANDEL:   I thought, Mr. Chairman, as a Hawthorne fan, the idea of a "scarlet letter" would appeal.

CHAIRMAN KASS:   Not if you have to go looking for it.  If the men in the clinic sort of wore it when they met their patients and people knew what it meant, it would be a different matter.

Let's look at this second section on the increased oversight by professional societies.

Gil, sorry.

PROF. MEILAENDER:   Before you do that, I just had a general question.  These recommendations all seem sensible enough to me, and they deal with information that one would like to have.  Do we have any idea what the cost of doing everything that we recommend here might be?

I just ask because nothing is easier than to recommend that money be spent on something, and it would be nice to know what, in fact, we are recommending in terms of cost.

CHAIRMAN KASS:   I think some of that knowledge is available in relation to what is now reported, and the last item here is the recommendation that funding be increased, but it seems to me it would  be responsible to know something about the figures before one went off, and if it turned out then we could perhaps even pick and choose amongst some of these things that seem more or less important and give the emphasis.  But we'll find out some of that information.

With respect to the increased oversight by the professional societies and the industry itself, here these are suggestions that the Council would offer in the spirit of collegial encouragement to the industry to consider these things and see if some of these things don't make sense to them as a way of improving their own practice.

And they have to do with improved informed decision making, treating - since there's some ambiguity about children-to-be, let's call that "children who will be born" as patients so that there's no doubt about who we're talking about.

Something on the improvement of the enforcement of existing guidelines.  It has been noted that the guidelines are merely hortatory.

And then let's just start at the beginning.  Anything on the informed decision making?  Rebecca, this is an area of interest to you.

There has already, I think, been some movement on Item B.  I think I'm right in thinking that greater collaboration with pediatricians has already, I think, been developed even in the course of the last couple of years.

But - Michael.

PROF. SANDEL:   This isn't a comment on that particular recommendation, but a procedural suggestion that may or may not be useful.  If it turns out that there isn't anything terribly controversial requiring discussion of this and since we've allocated actually a shorter amount of time for Section III where I'm sure since we haven't discussed it there will be extensive -

CHAIRMAN KASS:   Fine.

PROF. SANDEL:   Rather than fishing for comments that there may not be on this -

CHAIRMAN KASS:   All right.

PROF. SANDEL:   - could we consider merging this session into the next?

CHAIRMAN KASS:   I'm happy to do that.

Let me raise the flag then and say that anybody who wants to shoot at the remaining recommendations in Section II may do so now.

DR. McHUGH:   The only point I want to make, and it's a trivial one, I'm sure, for the rest of the Board to realize, that I'm still concerned about the issue of the women who have been exposed to these hormones and the like.

In my lifetime, after all, the two major public health bans that it turned out have been related to issues related to hormones given to women at various aspects of their lives, the use of estrogens and progestins to maintain pregnancies and later development of vaginal cancer in the offspring, and the recent embarrassment of demonstrating that estrogens are damaging to women after menopause.

So I want to be sure that in this first two sections we remind ourselves that these hormones and women who are exposed to them in huge doses are not trivial matters and have proven not to be trivial before, and that medicine itself has tended to overlook these possibilities with devastating effect to the public.

CHAIRMAN KASS:   Well, is your suggestion, Paul - we have something on that, not quite emphasized, on page 4 with respect to the federal study.  Are you suggesting we add this to the recommendations to the industry?

DR. McHUGH:   I recommend in the prologue to this that we remind people that we have made these major errors.  That's the point.  These were not small errors.  These were big errors that turned out to affect women and were ignored and only discovered very much when we decided to do things like Jim is suggesting, prospective studies as well as monitoring epidemiologically the discovery of women's effects.

And I don't hear that loud and clear here.  That's all.

CHAIRMAN KASS:   Robby.

PROF. GEORGE:   In response to that, Paul, my sense is what we're proposing here really are studies, not necessarily monitoring; that part of the purpose of the studies is to see whether it's advisable and feasible to conduct monitoring in certain areas that ideally, of course, everybody would like to conduct.  Is that right?

We're using the terms "studies" and "monitoring" in the conversation together, but my sense is that we're not really in a position until we have the studies to suggest monitoring or any particular protocols for monitoring.

DR. McHUGH:   All I'm saying is that I agree with that, Robby.  I'm just saying that these matters have turned out to be much more subterranean than we thought and yet had much more devastating effects, and so the purpose of us putting this out here is that it's not that we're just aimlessly wandering around thinking about what we might study, but saying, "Gee, this has been serious in the past, and it's a concern to us."

I just need a sentence or two to make that point.

CHAIRMAN KASS:   A paragraph from you by next Monday.  Thank you.

Let's see.  Frank.

PROF. FUKUYAMA:   Before you leave this section, I'd like to point out that Paragraph D, "improved procedures for movement of experimental procedures into practice," if it's simply hortatory to the industry, I think it should probably be said right now that almost nothing is likely to happen in this area because the things like animal studies, IRB oversight, you know, are all fairly complex, slow things down, costly.

I don't think anybody is going to go to an IRB if they don't have to, and most of that industry doesn't have to because you're not dealing with, you know, federal funding.

We've heard that, you know, animal studies are actually irrelevant for a lot of the procedures because, you know, they don't work in nonhuman primates and other, you know, animal targets of research.

And so I think that rather than part of the hortatory part of this recommendation, you know, in a way what needs to be done is a little bit more study of the whole issue of if you wanted to be more thoughtful in the movement from, you know, experimental procedures into clinical practice, what would be required?  I mean, what's possible, you know, in this area that might be, you know, practically adopted.

CHAIRMAN KASS:   As a practical matter, you're suggesting that something be put in its place and this be dropped or -

PROF. FUKUYAMA:   No.  You know, it's harmless as it is.

CHAIRMAN KASS:   Sure.

PROF. FUKUYAMA:   I just don't think it's going to lead to anything because I just can't imagine the industry will do any of this stuff, given, you know, how difficult and costly it is if it's simply because we suggest that they do that.

There have to be incentives in place, you know, to really -

CHAIRMAN KASS:   I understand.

PROF. FUKUYAMA:   - in order to make that happen.

But what it is we want to have happen, I think, is not sufficiently clear at this point.  So, again, something like animal studies don't seem to be possible for a lot of these procedures, and so I think we need to know more about, you know, if you wanted to somehow make this transition, you know, a little bit more of a barrier that, you know, just like clinical trials in bringing a drug to market.  What is it that we could reasonably expect from the industry?

CHAIRMAN KASS:   That's good.  It's a matter of reformulating what's placed here, yeah.

There was a hand.  Michael.

DR. GAZZANIGA:   So as we get through Sections I and II and you have a body of recommendations here, do you see any value in approaching one or two of the professionals who are involved in these activities and saying, "Look.  Here's what we've come up with.  Would you care to comment"?

Because there's a million trip wires when you start recommending things.  People who know the specifics underneath this, who work on it day to day, might come up with some ideas that would help clarify or maybe even augment these recommendations.

And, furthermore, at the end of the section, you might get an enthusiastic response, at which point you can add that the recommendations made by the Council have the endorsement of X, Y, and Z professional societies.

Do you see anything lost in that?  The only thing I can see lost is one can at least do it informally just for knowledge guide the written remark, but because they will have the procedure they'd have to go through if it was probably official, and we don't have the time.

But you could certainly benefit from their wisdom, and I think it's just a simple thing that we would all tend to want to do.

CHAIRMAN KASS:   Does someone want to comment to that?  Frank.

PROF. FUKUYAMA:   Well, again, since Sean Tipton is here, I don't want to put him on the spot in terms of speaking, you know, formally on behalf of the industry, but I would be curious whether there's anything, you know, in this set of recommendations that is particularly objectionable, that you see is problematic, something that has been left out.

CHAIRMAN KASS:   May I suggest - well, Sean, feel free to speak, but I think it's an unfair thing to do to him.  He's seeing the document for the first time.

By the way, things that are here reflect conversations that grew out of the testimony that the society members gave at various meetings.  We haven't been simply proceeding in the dark, but I think Michael's suggestion is absolutely well taken, and he doesn't miss a meeting when this topic is here, and he knows that his comments and the comments of the professional associations are welcome.

MR. TIPTON:   Let me just say -

CHAIRMAN KASS:   And, by the way, we got submissions.  Remember this process began when a whole list of organizations were asked to submit things, and they performed part of the background of this.

But you're absolutely right.  It would be very valuable to pass this.

MR. TIPTON:   I think we'd be happy to respond specifically to what some of the practical -

CHAIRMAN KASS:   Implications?

MR. TIPTON:   - concerns would be.  I think that they basically can be summarized just in terms of privacy concerns and cost concerns, and particularly what you're going to do here probably is you might change some things so the CDC would require different things in the reporting.

The burden of that is going to be borne by the practitioners and going to be passed on to the patients and the field of medicine for which they are largely not covered by insurance.

And so privacy and cost and practicality are probably the biggest concerns, and we would be happy to try to spell out some of the specific points where we have other problems or where we think things might work and be able to specifically say how they could work.

CHAIRMAN KASS:   Thank you.

If we could be in touch with your office this week, it would be helpful.  Next week I should say.

Janet and then Bill.

DR. ROWLEY:   Yeah, I wanted to go back to E on page 11, which is still in Section 2, and I'm curious.  The reference the third line from the bottom about "prospective patients (sic) may have interests that conflict with those of their future child."

CHAIRMAN KASS:   Parents.

DR. ROWLEY: I'd be interested - yeah, "prospective parents," right.  I don't have my glasses on.

I'd be interested to know an example where you've spent $50,000 to have a child and your interests and the child's interests are different.

CHAIRMAN KASS:   The question of the risk of multiples would be an area where the great desire to succeed allows people, in fact, to increase the chance of success, but increasing it at the cost of producing twins or triplets with increased health hazards.  That would be an area in which - now the question of how you compare a life with defects versus nonexistence is, of course, an insoluble conundrum.

Frank, were you going to respond?

PROF. FUKUYAMA:   Well, this is not an American case and it doesn't cost $50,000, but if you use sex selection, you know, through selective abortion, the interest of the parents are clearly at odds with the female child that was never born.

DR. ROWLEY: Yes, but that's not directly relevant to this section.

CHAIRMAN KASS:   Yes, it would be.  I mean, that is to say - no.

Further comments, Rebecca?

PROF. DRESSER:   I'll take responsibility for — I suggested this "interventions that could affect the health and well-being of a future child should be subjected to at least as much ethical scrutiny and oversight as interventions affecting humans after birth."

And then I said, "Arguably, a higher degree of scrutiny is justified."  And, I mean, I was thinking there about how we treat parental decision making for children in the medical context where there are some limits on parents' free choice.  So I was trying to draw a parallel there.

I would be a little more comfortable with just saying a high degree of scrutiny and oversight is justified rather than a higher - To me I would see it justified as equivalent to what we give children who are already born when they're in a situation where parents are deciding.

CHAIRMAN KASS:   Okay.  Someone else, or can we wind this up and move on to the other matters?

(No response.)

CHAIRMAN KASS:   Let's see.  We're 15 minutes away from where the break should be, and the second session will be shorter.  Let's take a break and come fresh to the new materials.  Fifteen minutes, please.

      (Whereupon, the foregoing matter went off the record at 9:43 a.m. and went back on the record at 10:00 a.m.)

SESSION 6:  BIOTECHNOLOGY & PUBLIC POLICY: PROPOSED INTERIM RECOMMENDATIONS, II

CHAIRMAN KASS:  Why don't we get started, please?

At the moment there are no sign-ups for public comment.  Why don't I suggest depending on how this goes, but let's aim for an adjournment at noon or earlier, you  know, if the irenic spirit descends and we find ourselves in full agreement on this and that.  We could leave as early -

DR. FOSTER:   Yes, several of us have to leave at 11:30 for flights.

CHAIRMAN KASS:   Then let the irenic spirit arrive earlier than that.

Let me begin by saying something about this particular part of the document, and let me put it in a slightly more grandiose place.

You might remember that President Bush, when he met with this Council on the day of our first meeting in January of 2002, urged us to be the conscience of the nation in matters bioethical.  He didn't explain what that meant exactly.  It was, however, I think to be understood not as a charge to this or that particular moral conclusion, but rather to the kind of moral seriousness, a most appropriate charge seeing that we are, in fact, an ethics Council in an area fraught with enormous human significance.

We're not an economics council, not a public health or scientific research council, but we're concerned really with questions of public right and of common good and not simply our own private interests.

Second, on several of the large ethical questions that have emerged on our agenda, we are deeply and probably permanently divided:  the question of the moral standing of the early stages of human life being the most obvious issue in which that's true.

Nevertheless, I think it's fair to say that there are other moral questions, matters of deep human import where I trust that we are not divided or at least not unbridgeably so, and insofar as we try to serve as the nation's conscience and teacher in these matters, we shouldn't be shy about saying so.

Third, we have in our approach to bioethics tried to begin where possible not simply with the conundrums that technology poses, but with a clear eye on some of the human goods that we wish to defend or promote.

And it seems to me as we look at this particular area of biotechnology and explore its human significance, we would be remiss as an ethics Council charged with this task if we failed to try to articulate some of those goods that we share and offer some suggestions, if they are sensible, about how those goods might best be promoted or defended.

And the material presented in Part III of this working paper is, in fact, presented in that spirit and with that intention.  It is, I confess, the part of this enterprise that is especially dear to me because it's an opportunity to articulate and give effective voice to things that are important to the integrity and dignity of human procreation.

It's an opportunity to suggest or even direct different kinds of interim boundaries as this field moves towards a possible way of regulating itself, interim boundaries that we would not allow roguish or irresponsible people to cross before the public could deliberate and decide about the ethical and social implications of doing so.

It's an opportunity to show that pro-lifers, scientists, and people of all other kinds of stripes can actually join in suggesting certain kinds of boundaries; that the scientists, for example, are not simply interested in just full steam ahead, but they are moral and responsible beings; that people who ordinarily wouldn't enter such a conversation because it seems to involve the defense of embryos only might find a way to join with others on those places where we could agree.

And it is, I think, a way to see if we can find a way around the moral and legislative impasse that exists when the battles are formed solely or mainly about the human embryo.

So those are among the reasons why I'm particularly interested to see whether there's something here that we can do.

And what this last part of the working paper that's presented for discussion attempts to do is to suggest certain kinds of principles and desiderata regarding the dignity of human procreation and under each one suggest possible kinds of measures that the people's representatives might consider enacting as interim measures while the conversation about further regulatory possibilities continues.

I think that's the spirit in which this is to be read.  I think we should proceed by the discussion of the principles first and then look at some of the particulars.

I know that among the particulars that have been placed here there will be some that will meet objections.  Quite frankly, there is the expectation that not everybody is going to agree on those, and where there isn't agreement, I think the general sense should be they should be taken out.

We're searching for certain kinds of - I think these are very modest.  I think they're rather minimal sorts of things, though not everybody might agree, but I would like to begin by suggesting that we look at the principles on page 13; that due regard for the integrity and dignity of human procreation might mean (a) a respect for the humanity of human procreation, preserving a clear boundary between the human and the nonhuman or between the human and the animal; respect for women and human pregnancy, protecting them against certain exploitative and degrading practices; respect for the children who would be born with assisted reproductive technologies, securing for them the same rights and human attachments naturally available to children conceived in vivo; and respect for the early stages of nascent human life, at least this much setting some agreed upon boundaries of why embryos may be made and/or how they may be used and treated.

This is an attempt to say that respecting the dignity of human procreation involves these different at least articulable aspects.  We can then look more particularly under - and it might turn out that the conversation is best had in the particulars, but that's what I think Michael is suggesting.

But if someone wants to just very briefly say something about the principles as a whole.  Michael.

PROF. SANDEL:   Well, I hesitate to raise this first because it doesn't seem to me the most important point, but it comes up in the principles, and if that's what you want to discuss first, then I would raise it under this heading.

Principle number one seems on the face of it unexceptionable.  Preserving a clear boundary between the human and the nonhuman, and it relates to the paragraph at the bottom of the page after the principles, proposing that Congress ban or have a moratorium on human-animal chimeras and so on.

I myself find the prospect of human-animal chimeras unappealing and troubling, but that is not a subject that I've thought very much about, that this Council has devoted a single session to.  I'm aware that there are very deep differences and interesting philosophical and theological differences between Judeo-Christian moral traditions which do mark out very clear boundaries between human beings and nature and Eastern religions, including Hinduism and Confucianism, among others, that conceive or understand there to be a continuity of a kind that's unfamiliar to the intuitions of those of us raised in this tradition.

I think it would be an interesting philosophical question worth devoting a session to, but since this Council hasn't addressed any session to the discussion of the relation between human beings and the natural world and the continuities and discontinuities, though I don't have a disagreement with, at an intuitive level, rejecting, having Congress pass - I don't feel that I'm ready or that this Council is ready to take a position on the whole question of the relation between human beings and animals.

And I would just mention as an example in the debate about genetically modified food and organisms, there were those who instinctively, you know, rejected the idea of transgenic manipulations that put the flounder gene into a strawberry so that it wouldn't freeze as readily.  Some found that intuitively very unattractive, and others argued in defense of it.

So now that's a less maybe faithful question than the one of human beings in relation to nature and animals, but we just haven't discussed that question.  Why are we asking Congress or suggesting that Congress enact something that we haven't discussed at all?

CHAIRMAN KASS:   The question is open.  Bill.

DR. HURLBUT:   Well, from a slightly different perspective, I think we have to be very careful on this subject because the scientific possibilities are - first of all, they're very hard to define.  For example, Catherine Verfaillie has put adult at least mouse, maybe human MAPCs, into the blastocysts of mouse embryos.  So it's not blastomeres or gametes we have to deal with here in this question.  It's a much broader scientific issue.

And, second, there will be a lot of good uses for the kind of things that Michael just mentioned.  There are already research models.  For example, there are combinations using different techniques of developing mice with human neurons in them that may provide very good study models.

We certainly want to be careful not to preclude good science.  I would just say that I think this is part of a larger category we need to consider or it would be good if we could consider or somebody needs to consider which takes into account this very interesting question.

If gene transfer doesn't define the locus of human dignity, I don't think putting a human neuron into a mouse makes it - it doesn't make it into Mickey Mouse.  It doesn't start talking.  I don't think it's -

CHAIRMAN KASS:   It doesn't say anything about that.

DR. HURLBUT:   No, I understand, but what I'm saying is as written, I think I could agree with what's on here, but we're entering into a territory that has many very subtle scientific issues in it.

CHAIRMAN KASS:   Let me hold back and let others participate in this, please.

PROF. MEILAENDER:   There are a couple different issues on the board.  I mean, one is the more general one Michael raises, and I just have to think about that.  I mean, you're right.  We haven't devoted any session precisely to the discussion of this.  It obviously relates to things that we've discussed in other ways, but we haven't, and I need to ponder that a bit.

I just need to be instructed with the more specific matter, whether the kind of genetic engineering that Michael was talking about with respect to non-animal forms of life or what you were talking about, Bill, has to do with the creation of like a hybrid embryo, for instance.  You weren't really talking about that, were you?

What you're talking about falls short of that or not?

DR. HURLBUT:   It's not creating an embryo to take to term.  It's creating a research model.  Are we specifically talking about the creation of taking something to term?

PROF. MEILAENDER:   I didn't read it that way.  I read it as simply creating a hybrid embryo.

DR. HURLBUT:   Well, see, my point is if you can take a human MAPC and put it into the blastocyst of a mouse embryo, you can get a model of the development of human tissues.

Now, whether that's good or bad we should talk about, but that kind of thing is being done, and there is some very interesting science coming forward with it.

And we want to be careful not to - I mean, it needs moral discernment.  That's all.  I mean, maybe as a moratorium or a temporary area we would delineate, maybe that's okay, but I think we have to recognize that this is a subject that needs to be talked about, not one that we need to just take the first and natural reaction;  we don't want to create human-animal hybrids.

There will be very good scientific uses for this technology is what I'm saying.

CHAIRMAN KASS:   And does that - Elizabeth, excuse me.  Please.

PROF. BLACKBURN:   This does speak to something general in this section that I noticed, which was that I didn't see distinctions between something in order to produce a child as opposed to creating something for research purposes.  In a number of places I was confused as to what was meant, and this is an example here.

CHAIRMAN KASS:   Rebecca.

PROF. DRESSER:   Having read some about transgenic animals, there are some philosophical discussions about, say, you had a chimpanzee and you put in new human genes.  How many human genes would it take before it became a chimera?

And I don't think there's been any agreement on that.  So that would be another issue.

PROF. SANDEL:   In fact, if I could just add that this isn't merely a hypothetical.  The kind of thing Rebecca is doing, the internal Harvard Ethics Review Board has had to deal with a question very like this, and the answer isn't obvious to me.  I don't feel equipped, now certainly, to know exactly what the science is, what the ethical questions are.  We simply haven't discussed any of this.

It's interesting.  It's worthwhile, I think, but we should discuss it.

CHAIRMAN KASS:   The larger question about the human / animal boundary with the movement of genes and so on and cells is a question we have not taken up, and it is a possible question for this Council.

And in an earlier draft of this, things were written up in a more almost legislatively looking way, and it would be possible to write in the disclaimers of what this was not.

As I understand what's here, this has to do not with the transfer of a few genes or not with the transfer of a cell, but producing a being that is an animal-human chimera limited in this way:  combining a human gamete, egg, or sperm with a gamete from any nonhuman species, or by taking two early embryos, one human and one nonhuman, and mixing them together to produce some kind of intermediate form.

This is not yet about for procreative purposes, but this is a suggestion that I guess the question is are we comfortable saying that in the absence of careful understanding of what this might mean, that let somebody go do it and we'll worry about it later, or is this one of the boundaries in which one wants to say in the absence of full discussion of what this might mean, let's have a temporary restraint on it?

If there's disagreement, it disappears, but I think that was the spirit in which it was offered, granting that the larger questions about animal-human mixing is yet to be had.

The second point, by the way, about the transfer of human embryo into the body of any member of a nonhuman species has come up in the context of the discussions of the further reaches of embryo research and of cloned embryos.

Paul, Mary Ann, Elizabeth, in that order.

DR. McHUGH:   I just want to follow on after Elizabeth's comment.  We're talking here about procreative, reproductive studies, are we?   Because remember we did touch briefly upon this back in the SCNT and the cloning arena when, again, the problem of SCNT demanding huge numbers of human eggs to be nucleated seemed a burden, again, to women.

We did discuss the possibility that for stem cell research that any ennucleated animal ova would work here and that that might be one of the ways that the science would advance, not to produce a chimera of being, but rather to produce stem cells from a person that would then be available to that person for repair.

And that's not being discussed here, is it?  That's why I'm following on after Elizabeth's question.  I mean, if it's procreation and producing chimeras, that's one kind of thing.  If, on the other hand, we're denying ourselves right now the direction where SCNT might go for stem cells, we should really think very seriously about that.

CHAIRMAN KASS:   This was not intended to cover the human nucleus into a rabbit egg, and that could be made explicit.

PROF. BLACKBURN:   I think this needs - I'm seeing some real concerns here, and Bill started to raise this issue.  So what if somebody takes a legitimate, you know, preapproved human embryonic stem cell and wants to put it into a mouse model system?

You've just said that is not going to be - i.e., a mouse embryo model system to study those cells, which I think would be taken as a very reasonable mode of study.  This would not allow that kind of thing to happen.

So I think there may be some unintended consequences from the vagueness of this.

CHAIRMAN KASS:   Well, let me put the general - Dan, did you want to this?  There was somebody else in line.  I've now forgotten.  Was it Mary Ann?  Yes, sorry.

PROF. GLENDON: Not on that particular point, but a general suggestion.

CHAIRMAN KASS:   Go ahead.  Turn your mic on and go ahead.

PROF. GLENDON: Okay.  I think before we get more into the details of the specific measures, it might be useful to think about our relationship as a Council to what the President asked us to do, the way we've conceived of our mission in general as raising the level of national conversation on a number of issues, and then our possible relation to what Congress might do.

That last thing is a new area for us, and I just want to float this suggestion that it might be that the most useful thing we could do here is to announce our consensus if it is possible.  It would be very impressive to have a consensus on this Council on the four principles in the report.

And second, to suggest the need for Congress to consider interim measures without specifying what those measures might be.  We could elaborate on the issues that we've identified, but keep in mind that before Congress did anything in this area, Congress itself would have legislative hearings

CHAIRMAN KASS:   Do you want to address the general comment?

DR. ROWLEY: Following on with Mary Ann's suggestion and then going back and looking in a sense even more carefully at the four items at the top of page 13, I wonder for Item 4, respect for early stages of nascent human life, setting some agreed upon boundaries.  Then it's on "why embryos may be made and how they may be used and treated."

And I'm not sure particularly with the last part of the phrase "how they may be used and treated" whether we really want to enter into that kind of suggesting that  Congress consider legislation in this area when that's an area that's still, if you will, under exploration. 

So I guess I certainly have no problem with saying that there should be respect for early stages of nascent human life, but I think that we should make it a more general statement.

CHAIRMAN KASS:   Well, let me response to Mary Ann's more general point unless someone else would like to.  I certainly hope that there - and Janet indicated that the language may have to be refined even in the formulation of the general principles.  I'm not sure I like that the way it is now written.  Its full meaning comes out, I think, when you see some of the particulars that are added.

Assuming that we could get an agreement on these very modest proposals or whatever modest proposals survive the discussions, I think it would be much more useful to, in fact, suggest something that looks like specific legislation for the reason that it would produce the kind of discussion that the mere hortatory suggestion that Congress might consider this might not produce.

You have, after all, over there an impasse on the one piece of legislation on cloning.  Is that impasse simply to frustrate all possible efforts to have some kind of interim measures that would at least hold certain kinds of lines while the society continues to deliberate about these things and while one looks for ways to monitor and regulate these activities?

Here would be an opportunity, assuming we could agree, to make a suggestion for something very, very modest and, I think, concrete.

Now, if you can't do it, you can't do it, but I think I've learned at least one thing, that if you want people to pay attention to the seriousness of your reflection, sometimes it helps to suggest that they do something, and otherwise it's a nice report.  You just go away.  It was nice.  Thank you very much.

Now, they can still say, "Go away.  Thank you very much," but at least there's a concrete proposal out there to fight with, at least for someone to consider taking up.

And I may be wrong about that, Mary Ann, but please come back.

PROF. GLENDON: Well, I think to suggest the need for legislation on interim measures is concrete, and maybe in the course of the discussion we can get even more specific than that about certain interim measures.  My guess is that we might be able to get consensus on some, but not on others.

But just as Item No. 1 opens up a great number of questions and intersects with a great number of questions, that Congress would have to consider and that we haven't fully considered, these other items similarly do.

For example, in three - can I make a comment about three or do you want to wait?

CHAIRMAN KASS:   Well, go ahead.  You have the floor.

PROF. GLENDON: I just would point out the idea of legislators acting to make certain that no child conceived by means of artificial reproductive technologies be denied two adult human biological parents.  There is a whole range of questions that are heating up currently and that have been addressed by other countries on access to artificial procreation by persons of the same sex.

I think Americans have not generally come to terms with the fact that civil union legislation in practically every country in the world that has it specifically forbids access to artificially assisted means of reproduction. 

There's just a whole hornet's nest of issues here that are related to the issues that we're posing.

CHAIRMAN KASS:   Michael.

PROF. SANDEL:   Well, I think that we can and should do as Mary Ann has often reminded us, contribute to framing national public debate about questions as we did with the cloning issue, and I think as you, Leon, suggest, one way of doing that is to see if we can agree on some recommendations to Congress.

And I think that we might well be able to do both of those things if we devoted one or two sessions to this question of transgenic.  There are two issues that have come out in this discussion that could be the basis for an agenda for that.  One would be what counts as a hybrid, which is what Bill and Rebecca and Elizabeth have raised.

And the other question, also a philosophical question, but at another level, is just as with reproductive cloning, almost everyone came into that discussion not liking it, but we had some very interesting discussions trying to sort out why.  What were the reasons for objecting to reproductive cloning, and what did they commit us to?

Likewise, with human-animal chimeras, I suspect most people around the table don't like that any more than they like reproductive cloning, but actually sorting out what's wrong with it and examining whether those reasons are supportable and what else they might commit us to, that might be worthwhile, very interesting.

In any case, it's nothing that we've done yet.  So we could very well make recommendations, and they might well be consensus recommendations, but I think we need to have a couple of sessions on it.

CHAIRMAN KASS:   Jim Wilson.

PROF. WILSON:   I agree with Michael.  I do not think that stating the four general propositions on the top of page 13 will command any legislative attention whatsoever because the legislators will disagree as to what these phrases mean, and in the course of their hearings they may put in there things that we as a council, perhaps unanimously, would find quite objectionable.

We have to flesh out what these mean, enough to get the process started in a way that may make some sense, and we have disagreement about chimera.  We have concerns to me about restrictions on so-called surrogate parentcy, at least for pay.  We haven't talked about that.

This is an extremely complicated question.  There are many court cases to which we can refer.

Later on we talk about we shouldn't preserve any embryo past the tenth day.  Well, why the tenth?  I mean, in the past we've talked about the 14th.  The British talk about the 14th.  So that my recommendation is that we return this Section III to the staff to see if the four principles, which taken simply as principles are general enough to command a lot of dissent, but not much agreement, and see if they can spell out what is meant and what is not meant, and provide us perhaps with alternative meanings so that we can choose among alternative meanings.

In the end, we may not have a consent, but we will learn a lot from the effort to find out whether we have a consent, and surprisingly, we may.  And if we do, then that's an advantage to the legislature that goes well beyond simply stating the four general goals.

CHAIRMAN KASS:   Rebecca.

PROF. DRESSER:   I agree that it would make more of an impact if we could give examples and agree on some principles, but I also agree that we need more facts and more analysis.

Another topic, on page 14, the middle paragraph about the two parents, there are these infertility approaches, ooplasm transfer and some other things where you have children with two mothers.  Now, maybe we want to say that's not a good idea, but I feel uncomfortable because I want to have some more exploration and some more scientific background before I take that stance.

On the other hand, I do think, for example, this principle number two, respect for women and human pregnancy, I would change it to "preventing certain risky, exploitative, and degrading practices."

I think that is strengthened by the example of not permitting a pregnancy purely to produce a fetus for research purposes.  I think that's a stance that almost everyone would agree on.  I know I have some colleagues who wouldn't agree with that, but I think that's fairly noncontroversial.

And so in that sense I think the principle itself could be read quite broadly, but giving the example improves on the recommendation.  So I do think that they would be stronger if we could give some examples, but I think we need more of an evidentiary basis before we do that.

CHAIRMAN KASS:   What do you mean by an evidentiary basis?

PROF. DRESSER:   Some more scientific background on some of these specifics.  Certainly this ten-day limitation, why ten days?  Some philosophical analysis, some -

CHAIRMAN KASS:   Yeah, well, I don't know who else wants to weigh in on this, but what more do you need to know?  What more do you need to know before you'd be prepared to say that it's really a bad idea to transfer a human embryo into a pig uterus?

Anybody here propose what we have to study in order to have a conclusion on that? 

(No response.)

CHAIRMAN KASS:   Is there somebody who wants to say that the benefits of scientific research of allowing the embryo to grow up to three months in a nonhuman uterus so that we can either study development or harvest the kidneys?  Because that can happen.

Do we want to say that, well, we have to wait for the evidence, or do we want to say, "Well, let's wait a see until somebody does it"?

What kind of scientific evidence or further moral discussion do you want to say that it's really a bad idea.  We think collectively it's a bad idea.  We might not be able to give the rational reason, Michael, just as I don't think you could give the rational reason for why we think incest is a bad idea, a sufficient rational reason.

That we think it's a bad idea to induce women to bear experimental animals as human fetuses, as experimental animals.

PROF. MEILAENDER:   That's not what this says.  It implies it, but the way you said it makes it much more direct and easily -

CHAIRMAN KASS:   Take the point that Rebecca raises.  To prohibit the initiation of the human pregnancy, on page 14, using embryos produced ex vivo for purposes of research, for purposes of security fetal tissues or organs for transplant or for any purpose other than to attempt to produce a live born child.

The surrogacy I think is controversial.  I'm happy to drop it, but I'm wondering what kind of further scientific research people or -

PROF. DRESSER:   I gave that as an example of a specific that I would feel comfortable supporting that now without further evidence.

There are a lot of things thrown into this as examples, and I think some of them we feel -

CHAIRMAN KASS:   Well, then why don't we take the example case by case and see if any survive?

PROF. DRESSER:   Well, it seems there are three categories.  One might be examples that people would feel comfortable agreeing on right now, and then there are examples that people would say, "Well, I just don't think we should take a position on that," and then a middle ground where people might say, "Well, if we had more time to work this stuff through, we could agree on it."

CHAIRMAN KASS:   Okay.  But, I mean, some general comments or should we just look at the various things one by one and see?

PROF. GLENDON: Maybe one general comment to keep in mind something that came up, I think, in our very first meeting.  What's involved in the background of all of these issues is where is the burden of proof supposed to be?  Who ought to have the burden even of demonstrating either that a measure is needed or I think that's - if you wait for conclusive evidence -

CHAIRMAN KASS:   No, that's well said, and it seems to me the spirit of this is:  look.  We understand that there are larger and challenging things being developed here.  The approach of this project has been to explore the way in which we now monitor, review, and perhaps regulate these activities.  We've discovered that there isn't a lot that would regulate things of this sort.

We are recommending that the inquiry into regulation continue, but the question is whether in the light of certain kinds of rapidly changing things on the ground and things that individuals are doing, if you read the report of the European conference and the various things reported there, there is reason to be concerned that particular individuals, without consulting anybody else, for their own good reasons will introduce new kinds of innovations.

And the question is:  does one simply say, "Well, let's wait and see," or does one, in fact, say in the absence of adequate public discussion, the burden of proof lies with respect to certain limited things, very limited things; the burden of proof lies on those innovators to show why these particular kinds of human goods, boundaries defending these human goods should be violated.

And this would be an attempt to lay down at least a few minimum markers, in fact, to indicate that there is a burden of proof problem with respect to some of the things that affect the question of the dignity of human procreation.

I mean, I would say if you had one on each of these items I would be myself content.  I would think that if the question under the humanity of human procreation were to simply limit the implantation of human embryos and animal bodies, that's a limit, and it's a limit which maybe we can't all articulate equally.  I mean, we can't agree on the reason, but it shouldn't be, it seems to me, upon us simply the burden to state the reason.  The presumption is somebody else should show us why we should do that.  The burden lies there.

And we can talk about it at some length.  It seems to me similarly with respect to the women, I don't think the burden is on us to say why it is it would be a bad idea to treat women's bodies as laboratories and to treat the womb as a place for anything other than the nurturing and growth of a child.

I mean, if we're the conscience of the nation, how can we not say anything but that?

And on the question of the respect for the embryo, the question of the tenth day or the fourteenth day or what have you is arbitrary, but there was general agreement around here before.  Even the people who wanted to create the embryos for research thought that the respect that was owed the embryos was somehow required that there be some kind of upper limit on which embryos used in research should be created.

And this is formulated here in a way in which the pro life people, I think, might, in fact, be able to join it.  Since embryos are being used in research, is there for the time being, for the time being, a society-wide agreement to use them, but not past this point?

That seems to me a reasonable, sensible thing for a society as divided on the morality of this as we are to establish, and we've had testimony here previously from people who, you know, favored such kinds of boundaries.

And then on the question of the children, which is the vexed question, and I take your point advisedly, Mary Ann, but to achieve that result, one would have to have an embryo for a parent, and the question is whether children born with the aid of assisted reproductive technologies are - shouldn't we somehow secure for them, for the children now, out of our interest for the children, the same rights and human attachments that are available to children naturally conceived in vivo?

And does one really want to say - I mean, with the oocyte or the ooplasm transfer is easily dealt with as we don't mean to cover that, but one could say one doesn't really want children who have four biological parents because they're the product of the disaggregation and fusion of two embryos or that one, in effect, says that one should not attempt to conceive a child save by the union of egg and sperm attained from adults rather than from embryos or fetuses or anybody like that.

That seems these are contestable, but the first three I think are easy.

Elizabeth and then Michael.

PROF. BLACKBURN:   On first reading, one has the sense that, yes, these are all very reasonable.  What's increasingly concerning me is as we look at them carefully, I realize how unconsidered by the Council so many of these have been.

To take your very specific example of the four biological parents, now, I understand that now naturally occurring in the human population, at albeit low frequency, are cases in which exactly such natural chimeras exist.  Is that one you're talking about?

CHAIRMAN KASS:   I think people can't hear you; is that correct?

PROF. BLACKBURN:   Oh, I'm sorry.  I'm sorry.

So I'm getting increasingly concerned about while on first reading the principles do look like something that, yes, reasonable people like ideas, but the more I read them in the few days before the meeting that we could look at it, the more concerned I am that they haven't had the benefit of real discussion by Council and -

CHAIRMAN KASS:   That's what we're doing.  That's what we're doing.

PROF. BLACKBURN:   Yes, but there is a lot there.  And so, for example, the very specific case you raised of four biological parents, my understanding is that there are, albeit rare, but natural cases of human chimeras that naturally exist, and this has come up now in the context of, well, how do you do DNA identification because such things occur.

So, you know, immediately this starts to raise questions that I just think we would be sort of hastily not taking account of here, such as now are these people now to be recognized as, you know, not proper people?

There are all sorts of things that start rising up out of this even though I understand what you're saying.  The general principles seem good.  On closer examination, the more concern I am feeling about the unintended, as I said, misunderstandings that -

CHAIRMAN KASS:   Are you suggesting, Elizabeth, that - well, a general principle is if it happens rarely by nature, it's perfectly okay for us to do it by art, but are you suggesting that if somebody today simply wanted to create an embryo, a child who had four biological parents, deliberately, but that's something we should say, "Go ahead and do it"?  Are you comfortable with that?

PROF. BLACKBURN:   Well, I don't know about the specific example because we really haven't had time to think about it.

CHAIRMAN KASS:   But I'm asking you to think about it.

PROF. BLACKBURN:   And I might say if nature has done it with no obvious harm to the naturally occurring individuals who are now showing up as having had this, maybe this is not as terrible as our gut instinct, as you imply, is thinking it is.

I don't know.  That's the uncertainty, and yet I feel -

CHAIRMAN KASS:   Twelve parents?

PROF. BLACKBURN:   - hastily abandoning things which perhaps we haven't had time to think about.

CHAIRMAN KASS:   Frank.

PROF. FUKUYAMA:   Well, Leon, I have a diagnosis of what the problem is here because, you know, when you first suggested this set of principles, you know, I thought it was a good idea, but it does seem to me that the specific things that you would get ready consensus on banning all tend to be a little bit science "fictiony" or, you know, over the horizon and outlandish, and the reason that we haven't considered a lot of these things is that we've been reluctant to stray too far from things that are kind of here and now.

So that's why we haven't had a long discussion about human-animal chimeras, because nobody really seems to be that interested in doing it.

Another one that comes up, which is at Principle 3, I guess, union of egg and sperm obtained directly from two parents, that means you are excluding the possibility of gay couples using, you know, ART at some future point, as someone suggested it will become possible to produce a biological offspring.

We've not discussed whether gay parents have reproductive rights like that, you know, because it's not possible right now, but you know, people have suggested that that may be possible in the future.

It has come up in the discussion of cloning, you know, the long-term possibility that you would actually clone fetuses, you know, for the purpose of harvesting organs and tissues, but again, we didn't dwell on that very much because, you know, nobody is really pressing very hard for that.

And so I think that's the problem we're having, is that the things that we're going to get, you know, ready consensus on are fairly outlandish things, and I don't know.  Maybe it would help to have, you know, I  guess a more targeted list of those things.

But I guess in retrospect I'm not surprised that we haven't discussed them because a lot of them, you know, are really things that you can imagine happening in the next few years, but are not, you know, immediate pressing things that people are, you know, clamoring to do.

CHAIRMAN KASS:   Bill May.

DR. MAY:   I sense at the outset of the conversation, in a sense, some feeling that we've already done the work, and this merely scoops up what we've already kind of agreed to or Mary Ann's point that, well, the burden of proof doesn't lie with us and, therefore, we don't really need to articulate the full range of reasons.  If we're talking about certain practices, the burden of proof lies upon others and the reflection, well, reasons are hard to articulate, and you are wonderful on that subject in the discussion of cloning, but as a matter of fact, an awful lot of articulation did develop.

And I think Michael is suggesting that that comfortable kind of articulation would be appropriate on the subject of the question of the boundaries between the human and the animal.

Another question is whether this division of principles, on the one hand, that we all agree with and then a few illustrations doesn't clear out the whole question whether the principles are so generally stated that an awful lot of legislative mischief could walk through the door opened wide by the principles.

And even if you give an illustration on something that you mean by the principle, you haven't sufficiently carefully described the general principle in such a way that you either make it so general that nobody is persuaded to do anything legislatively - that was Jim's point - or it's stated so generally that too much can walk through that door that if not all of us, an awful lot of us might not want to see.

Because, after all, legislators looking at a document that we produce can look at the principles, ignore the illustration, and they've got that principle that they can invoke, and what kind of real counsel have we offered?

Those are some of my concerns.

CHAIRMAN KASS:   Let's see.  I have hands from Michael, Gil.

PROF. SANDEL:   I think that the general problem being discussed is whether the principles or especially the examples, though they might well generate consensus, haven't fully been considered, and if that's a weighty worry, it doesn't argue for scrapping this part of the project.  In some of the cases it argues simply for devoting a session or two so that we can articulate.

Now, you invoke the wisdom of repugnance in the transgenic case.  Well, maybe we can't, you know, articulate reasons for not wanting to put the human embryo in a pig uterus.

On the other hand, the wisdom of repugnance was invoked or could have been invoked also on reproductive cloning, and yet we did pretty well in articulating reasons for our instinctive, gut opposition to cloning to make babies.  We got quite a far way,

And our mission of contributing to public discourse was better served by that than if we had simply said, "Well, look.  If you don't see what's wrong with cloning to produce babies, there's something  wrong with you."

Likewise here, we might be able actually to make a contribution in articulating the reasons for the widespread repugnance that we presumably share to mix animal and human things or beings.

But it really wasn't the animal and human.  That's one issue, the question of what we haven't fully considered and how we might.  I mean, that's an important discussion, but there is one thing in here that reflects the opposite problem, something that we have very fully considered and that nonetheless in a document intended to reflect consensus is something that reflects one of the deepest divisions we had after six months of discussion, and that's on page 15, the last sentence of the first paragraph, where we are suggesting as an illustration that Congress include a moratorium on creating human embryos solely for the purpose of research, which would encompass a ban on cloning for biomedical research.

And we voted ten to seven here.  So we know there's no consensus.  This is the case where it was fully considered and where we know there's not a consensus.  So why include that in a document that is intended to reflect consensus?

CHAIRMAN KASS:   It should go.

Leaving the last point off, the other is an invitation to what exactly?  To drafting -

PROF. SANDEL:   Not to give up on this.  I don't think we should give up on this project or even on the idea of having specific suggestions about what Congress should consider, but I know it's a problem of the timetable. 

And I don't know whether this body will be renewed or not, but it seems to me worthwhile since we've gotten this far, and the regulatory project is a worthy and important project for all of the reasons that you've stated and others.  I think that if we actually devoted sessions to some of these paragraphs, we could probably achieve consensus and produce a regulatory report of this kind.

CHAIRMAN KASS:   Gil is in the queue, but shall we spend some of the time we have here on one of these sample points to see where we can go?

Gil, did you want to comment before we - I mean, the purpose of this was, in part, to float the idea, but also to concretely speak about the particular items that are here.

Some I thought would disappear.  Some I thought would simply disappear.  I think that the argument about surrogacy is likely to disappear for reasons that have already been alluded to, but there is at least a question as to whether that as a commercial venture is somehow compatible.  I put it down there because some people have indicated they would like it discussed, but I knew that it would be controversial.

But, Gil, why don't you go ahead?

PROF. MEILAENDER:   One hardly knows what to say at this point.   I'm not really sure what I think about how we ought to proceed.  I'd say just a couple of things.

I agree with a part of Michael's last point that we shouldn't do anything here that asks people, as it were, to retract a position that they arrived at after a long period of months of discussion that eventuated in our cloning report.  That just isn't the sort of thing that we should do, I believe.

The question is whether there is something that we can do without an enormous amount of time devoted to it.  The attraction of it is this.  I mean I myself could affirm many if perhaps not all of the things in the paragraph spell out and specify the principles, but you wouldn't need all of them to accomplish something that had a certain kind of symbolic result.

That is to say if you think of the way Leon couched the effort, we are thinking of a document that outlines what's going on that presents findings about it that suggests recommendations for various ways that more information that is needed could be gathered.

And then the question would be:  can one just even symbolically have a way of saying an individual should not simply forge ahead without thinking about the larger public goods that are involved.  You wouldn't need all of this to carry that symbolic freight.  You would need something probably.

Now, maybe we can just get along without the symbolic message entirely.  I don't know, but the advantage of something like this, even if a scaled down version that doesn't have everything, is that it does carry a certain kind of message that this report that we're contemplating probably could not carry without it.  I mean that, I think, is what we need to think about here, and I don't know if I have anything better than that to say about it.

CHAIRMAN KASS:   Robby.

PROF. GEORGE:   Leon, just a question of clarification.  Was the idea that what we're looking for here is necessarily consensus, that we would only go forward with a recommendation if all members of the Council agreed to it so that each of us would have a veto over every possible recommendation?

I mean that seems to have crept into the discussion, and it wasn't my understanding at the beginning.  I mean I can see the value of that.  I can see why it would be useful to get as much agreement as possible, and we certainly want to avoid division to the extent possible, but I just wondered if that was the understanding or even if that was the staff's understanding in preparing the document.

CHAIRMAN KASS:   I think the understanding was to see if we could find consensus on specifics, yes.  If we can't, there would be a kind of reconsideration, and to find consensus on specifics that are not the least common denominator.

Because we have set aside - I'll be corrected if I don't restate it.

Despite the continued differences about the status of the embryo, we are looking to agree on certain kinds of policy suggestions that as it states here should command not just the respect of the assent of people, but sense and will, et cetera.

And in this particular part, let me read from the working paper.  "In Section III, we identify for Council discussion several aspects of the dignity of human procreation that may warrant interim," interim, "prudent legislative action, especially in light of rapidly arriving innovations that signal new departures in human reproduction.  Familiar disquiet regarding human cloning or commerce in human embryos and gametes is augmented by recent reports of fusion of male and female embryos into one chimerical organism or the derivation of gametes from embryonic stem cells, in principle enabling embryos to become biological parents.

"Accordingly, while the policy makers monitor and gather information and while deliberation continues in search of better and more permanent monitoring and oversight arrangements, it may be necessary and desirable to enact interim prophylactic limitations which would prevent individuals acting on their own from introducing major innovations into human procreation in the absence of full public discussion and deliberation about their ethical and social implications and consequences."

That's the spirit, and it does, I think, have something of the symbolic character to articulate these are the things we care about.  It would be better if we could say why we care about them.  I agree with Michael fully on that.  That would be helpful, but that certain kinds of markers or boundaries are sort of set down as an indication of an expression of the concern in this time where in the absence of such one is going to be faced with facts on the ground in the absence of any kind of public discussion.

I think there was - Frank, was it you and then Mike?  Mike.

DR. GAZZANIGA:   Well, I think the concern here is that this document comes off as argument by freak show, and one can always - freak show?  I mean the extreme cases that seemingly are repugnant.

And the concern is that the scientific enterprise will be seriously impacted because of subtleties that we're just not thinking about; that people would read into the freak show principles or reasons why you can't do something straightforward.

So the issue that Paul raised about the Chinese work of the rabbit oocyte and the somatic cell nuclear transfer opportunity.  I mean, if you just look at that as a - the rabbit oocyte is a  value chemical (phonetic).  So that's what's going on there.  Now you're just taking advantage of it.

One interpretation on one of these readings might be that that would be precluded as an option.  That would be a terrible thing.

So we're not going to get around the concern today that a serious scientific exploration of the implication of a freak show argument, what they might be.  We have to sit down and go through that in a very careful way, and I don't think anybody is prepared to make those kinds of decisions today.  I'm certainly not.

And then finally, I'd just like to observe that all of this is admittedly sort of throttling down things, and one might say at the end of this two-year process the science that's gone on and what we heard yesterday, that one may want to throttle some things up; that, in fact, we heard rather dramatic information yesterday from the Parkinson's people about what they're achieving.

So, you know, I don't know why we don't have a Section IV, you know.  Here are the opportunities that have unfolded.  Here are the promises.  Maybe we should be changing our recommendations and Congress should be, too, making a stronger case for what ten of us actually voted for, which we had no ethical problem with biomedical cloning.

CHAIRMAN KASS:   Dan, is that a hand?

DR. FOSTER:   Well, I know that you don't want - I mean, every time I say that I know what you want -

CHAIRMAN KASS:   Go ahead.  Go ahead.

DR. FOSTER:   No, I'm not going to say it.

(Laughter.)

DR. FOSTER:   I'm not going to say that again, and he reminded me last night he still hasn't told me what he thinks.

It seems to me that a consideration of - you know, if we're coming up to the end of the Council, I think that one symbolic thing that you want to say after all of the study and so forth that we, probably most of us, have become more aware of the serious problems that may confront human beings that are worthy of elevating the goal of what it means to be a human being.  So that if we were to close today, you've got the regulations on the first two parts of this that we sort of went through pretty clearly without much major objection to.

And then it seems to me that this number three is sort of an epilogue which says we want to begin to remind of what we started with, that the human animal is a special and very wonderful animal that we as humans need to take care of.

And so, you know, the principles are in one sense principles of, you know, I'm not against motherhood or against God.  I think we ought to do these things.

But, on the other hand, if it's likely that there is to be an extension of the Council, I think a number of persons have said, and I think I find myself agreeing with this, that this would be - some of the things that have been discussed in this issue would be very important things to complement what we've already done.

In one sense I've thought, well, why should we extend the  Council.  I mean, the main thing was the cloning and so forth and so on.  But it might be that this really is a worthy project after which one could have a more - I think what I've heard other people say - a much more powerful way of saying that our concern for the sanctity of the human being, which I think not one of us around this table would wish to deny; I certainly think that my own concern for the human being, although I think it has always been profound, has been enhanced by listening to the learning things here.

So that if the likelihood is - and you would maybe know more than any of us would about an extension - is true, then this would seem to me to be a very worthy project, which I don't know what the October-November meetings are going to be on, but which we should entertain, and then the symbolic value would be enhanced by certain things that we would probably all agree with.

I think there are intuitive truths, you know, that all humans have, and some of these things would do that.  So I think that my own view would be that if it's likely that we're going to extend it, that we ought to take this as a very serious thing.

Some of the things that some of us have talked about, international bioethics and the treatment of disease and things of that sort might not be as directly under here.

So I think that I would join with those who say that we need an epilogue if this is over, and we might come to some general consensus and then give a boundary statement or two saying that, for example, one might do this, without giving any details.

But I think it would be a very worthy project to go forward and one which we would all learn something, and if we learn something, then our conscience statements for the nation - maybe that's grandiose to say we're the conscience of the nation - but if there's some element of that, it would be much more powerful, and I think it would avoid the sort of hurried sense here that if we're coming to the end, we want to have an epilogue, but if we're not coming to the end, we can make the epilogue stronger and more powerful after further discussion.

CHAIRMAN KASS:   Thank you.

Bill Hurlbut and then Michael.

DR. HURLBUT:   I feel that what we've written, what has been written here maybe with some of the specifics shaped a little differently is perfectly appropriate for the document as it stands and a very good thing to do, whether or not these issues are taken up by us in the future.  I think we're flagging certain important territories that we were supposed to educate the public to.  We have set them out here.

I think every one of these territories is important.  I didn't mean in raising the issue of the complexity of the chimeric hybrid creatures to deflect this.  I think this is a very good thing, appropriate for the document, and there's no reason not to do it.

But to just put an exclamation point behind what Dan just said, I think that one of the values of including this is that it's an acknowledgement that we're at the convergence of technologies, and we're at a very historic moment in the unfolding of science.

When genetics started to produce the kind of ethical problems that it has, there wasn't an assembled structure for speaking about it in place.  Now, at the equivalent beginning of the era of developmental biology, we have an opportunity to step in and actually make some prospective judgments and some real influence on how this unfolds before it unfolds out of control.

And I think that whereas it may be very hard to do things that have major impact through genetics, I don't think it will be with developmental biology.  I think we're looking at some very, very serious ethical concerns here, and we should have something like this in our document, and we should for us or others make it plain that there are important ethical territories here that need to be on the radar for the general society.

CHAIRMAN KASS:   Michael.

PROF. SANDEL:   Well, I have a concrete suggestion though, first, just to respond to Robby's point.  It was Leon who laid down the hope and the expectation and the aim that this could be a consensus report rather than one with voting with majority and minority, though I think Robby raises a good question, and it might be better to have it, if we're really going to delve into these areas.  I think that should be an open question, but that was the assumption that Leon laid and the hope that Leon laid before us.

But I think that would be worth rethinking for the reasons that Robby suggested, but as for a concrete suggestion on how to proceed, there are really three substantive areas that are covered by these paragraphs.  One of them has to do with the transgenic, the human animal, and that's essentially this paragraph on the bottom of page 13.

The other area has to do with patenting and commodification.  That includes the middle paragraph on page 15 and the last sentence of the first paragraph on page 14 about surrogacy.

Now, we've had in the case of the transgenic and human animal, we've had no sessions.  In the case of the patenting, we have had some sessions, though not on the surrogacy and not on the last sentence of the patenting paragraph.  We haven't really discussed, and I was surprised to see here as a conclusion that the law should be careful to clarify that human genes should be eligible for patents.

I don't think we really have discussed whether human genes should be eligible for patents.  My own not fully worked out view is that they probably shouldn't be, but in any case, that seems to me a discussion that would be worth having under the heading of patents.

But in any case, that's a second substantive area, and the third area is represented by the middle paragraphs having to do with ART and the embryo and genetic technologies, which we have discussed.

So one way of trying to try to do this, but to do it well, in a considered way, would be, depending on what the agenda is for the next meeting, and there may be competing things that we need to cover, to have one or two sessions with readings and so on on the transgenic question, what counts as a hybrid, what are the experiments putting, you know, human cells into mouse brains, embryo brains or whatever.  What are some of the philosophical arguments about the line between the human and the animal?

Have a couple of sessions on that with readings and discussion.  Then have another couple of sessions building on our patent, but broadening it to the commodification issues.  Should genes be patented?

If you want you could include surrogacy in a discussion of that there, and then that would just leave for really as a drafting question, since we've discussed a lot about ART and the genetic, reprogenetics as some people call it, and the embryos.  That we have discussed.  So there it's really a question of responding to drafting and language.

And then we would be in a position to maybe go ahead with something like this, but perhaps we don't have enough time in the October meeting to take this up.

CHAIRMAN KASS:   I think we will have to obviously digest what goes on here to sort of figure out the suggestion, the program for October.  I'm not sure I share exactly your analysis.  The way you've parsed this is certainly, I think, one way that it could be parsed, but the remarks on the patenting of embryos - the last sentence, I admit, has not been discussed, and if I had been on my toes, that would have been to say that this recommendation has not yet settled the question about the other.  In other words, we meant to be something pertinent to the embryo, period.

So this wasn't really an instance under the large subject of commodification, but an instance under the respect for the early stages of nascent life.

And I think the question about the human-animal boundary in general and the implications there would be a very rich thing to discuss, and there have been meetings on it and reported in The New York Times and others, and if we continue, that would be a topic at least worth putting on the agenda.

The question is whether there is a tiny piece of it that belongs under the heading of the dignity appropriation rather than - and maybe it doesn't belong.

Look - Rebecca, please.

PROF. DRESSER:   One other small, concrete suggestion would be to make a list of the specifics that you want to retain and then float it with some scientific organizations and ASRM, and just say, to avoid this problem of having unintended consequences, "Are there any concerns or things we should think about if we were to recommend some moratorium or something against these?  What would be covered?  Are there any problems that you see?"

And see what they say, you know, to a small group just to inform ourselves in an efficient way.

CHAIRMAN KASS:   I think - Bill, is that light on for a reason?

DR. MAY:   No.

CHAIRMAN KASS:   Sorry.  I thought you wanted to speak.  You can speak if you'd like.

I think while we could spend time discussing any of the particular items, I think it would, in the light of the larger questions about the enterprise and its shape be time not well spent today.

I think I've taken the temperature of the room.  We will digest the multiple comments, and this will be an agenda item in some for or other in October, unless you hear otherwise.

We've got a lot.  There are a lot of things sort of coming together here in these last few months.  So the exact agenda for October we have to work out, but I wouldn't dare summarize what I think I've heard here because I'd have to read it, but I thank you for the serious attentions both to form and content, and this will not be abandoned.  It will be brought to the next stage for discussion.

Jim Wilson.

PROF. WILSON:   If I may suggest in the interest of economy and the best use of the Council's time, let us minimize to the greatest extent possible external testimony.  We have enough to talk about among ourselves, and we can read -

CHAIRMAN KASS:   We have no plans for further testimony.

PROF. WILSON:   That's splendid.

CHAIRMAN KASS:   Yeah, we've got lots to do.

And actually, the people around the table who have spoken about the importance of trying to develop language to articulate these intuitions, this is one of the occasions because staff has a lot else to do; this is one of those occasions where the proposal to bell the cat carries with it the obligation to do so.

So I'll call on Michael and perhaps Bill to give us some kind of paragraphs maybe that we can actually put before people in addition to just the bare intuitions.  We can talk.  We'll sort it out.

Frank.

PROF. FUKUYAMA:   I've been trying to formulate this.  I'm not sure I'll get it quite right, but I actually wouldn't shy away from the freak show side of this just for the following reason.  I can guarantee, Mike, that if we continue down today to a list of things that you think are freakish, in ten years, you know, if these things enter into clinical practice you'll probably be saying, "Well, you know, what's wrong?"

And since the technology has proceeded as quickly as it has, there are a lot of things that people thought were freakish, you know, 20 years ago that have entered into practice, and I think it's not a bad idea to lay down, you know, a series of markers about things that we think are, you know, highly troubling even if they don't seem to be, you know, immediately possible but that, you know, could become possible in the next few years because, you know, I think precisely for the reason you said earlier, Leon; that if you don't lay down such a marker, then when it happens, people are going to say, "Well, nobody objected to this," or, "nobody said anything about this.  So what can we have against it?"

And I think that actually politically if you think about what really motivates people to worry about this stuff, it is these possibilities.  So I think that you don't want to dance around that too much by formulating very general principles, you know, without connecting them to, I think, some real technological possibilities that we will be, you know, in all likelihood confronting.

CHAIRMAN KASS:   Also on the one item, by the way, that never got any discussion, there is a very interesting proposal under the heading of the respect for the early stages of days of human life on the prohibition of use and research or the preservation for purpose of conducting research on an embryo past the tenth day, as it now states here.  That's not futuristic.  That's not futuristic.

And I would invite especially the scientific members of the panel.  I mean, it's always possible to say that there are many things that you lay down as restrictions that are going to get in the way of basic research, and you could probably find some good justification for even some of these freakish things if some benefit could be bestowed.

But the question is:  how is the public to take seriously the moral responsibility and conscience of scientists themselves if they aren't somehow willing to join in a collective body to try to hammer out those things that all of us as human beings - the things we don't agree on, fine, but to in a way, to make the extra effort to see if we can't for the time being and as interim measures only set down some of these markers that we could endorse whether we're scientists or not, whether we're pro lifers or not, but because we care about these kinds of things.

Now, it's important to do it right.  I have no doubt about that, and I think we'll give it a try.

There are no people signed up for public comment. 

The people who have to leave at 11:30 have five minutes.

Thank you all.  We'll be in touch.

(Whereupon, at 11:23 a.m., the meeting in the above-entitled matter was concluded.)