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Friday, June 13, 2003

Session 6: Biotechnology and Public Policy: 
Discussion Document on the U.S Regulatory Landscape:  Part II

CHAIRMAN KASS:  Well, why don't we get started.  I think that we have got a couple of more coming, and we can proceed.  Thinking how we should most usefully spend this second session, which will run until 11:30 when the public session begin, let me make the following suggestions.

I think we have some very helpful and constructive suggestions for how this document can be improved, both to make more explicit what we are doing, and to beef up the beginnings so that some of these larger issues are visible, and that he ethical matters are expanded.

And I suspect I know which of you cares more about some of those things and don't be surprised if we call upon you to do some drafting.  But it might be useful rather than to find further areas of limitation in the document to maybe go through section by section looking at — I mean, keeping in mind the larger human goods and concerns that we have, to look at the summaries or at section by section and see whether roughly the diagnosis is somehow seems to you to be fitting.

And we repeat that a diagnosis is a kind of evaluation as to whether certain kinds of things are or are not being addressed.  And while it might say something is missing here, it doesn't necessarily yet call for any particular remedy, because as has been pointed out, remedies might sometimes be either unavailing or they might make matters worse. 

I would like at least to flag one difficulty that was commented on at the break, and Frank Fukuyama alluded to, and Bill Hurlbut also.  So much of this — part of the reason that we spend so much time on the assisted reproductive technologies is that it is the gateway to whatever else is added to this matter.

And we have seen how as in so many other things that when things enter into medical practice, especially in this country, and especially with its decentralized form of medical practice, yes, there are medical malpractice constraints, and there are various other sorts of constraints.

But things become sort of routine in medical practice, and these things are left largely to a doctor's discretion.  And small, minor improvements in the technique are one thing, but adding whole new — I won't say powers, but capacities, to reproductive technologies will find their way into medical practice if precedent is any guide.

And that makes it exceedingly difficult I think for people to sort of scrutinize matters, especially if someone doesn't somehow think in advance about what they are likely to be. 

And if these are matters to be subject to some kind of public discussion and debate, then I think it behooves us, as the people in charge for looking over these matters, to call attention to what they might be.

That, in addition to the need for new information on existing practices and the like.  But what I would like to suggest is that we simply sort of look through the conclusions part by part, and see or using the conclusions as a kind of mnemonic for the analysis that we have gone through, to see where people are on this.

The first conclusion to the section on the capacity to initiate life, page 56 through 59, where the document identifies the particular objectives of Federal oversight, the indirect oversight, and CLIA, medical practice, and the ASRM's guidelines, and the like.  Rebecca.

PROF. DRESSER:  On page 58, the first full paragraph, about in the middle, "the guidelines provide no affirmative protection for the well being of children-to-be." 

I would take issue with that.  I think this whole phrase, "well-being of children-to-be," is used a little loosely in different places in this document.  I think certainly the guidelines, even though they are not enforce, say that the view that ASRM takes, that if they are to publish studies, and something goes from experimental to clinically acceptable — I mean, that might be a very weak standard, but that is requiring some kind of evidence of safety and efficacy.

Many of — you know, quality control, CLIA, all those things that are trying to promote standard — a good standard of care, and good practice in the lab, part of the motivation there is to make sure that children are healthy, physically at least.

CHAIRMAN KASS:  Right.

PROF. DRESSER:  So I wouldn't say no affirmative protection.  And I think there, as well as — and I will just bring it up later I guess, but at the very end, I think it would be helpful to perhaps separate psychological well-being of children from physical well-being.

Or if there are other kinds of well-being of children that are being thought about, that it again be more precise and specific.  The other — on that page, the other point I wanted to make was in the last paragraph. 

Let's see, the fifth line up refers to the structure of the human family, and the guidelines here, you are referring to the pediatrics guidelines.  And again there are some other references to that concept.

I want to know more about, well, are we going to take a position on what a good structure of a family is, and if so, what is that.  And that raises some concerns for me.  I don't think we want to be too loose about that.

CHAIRMAN KASS:  Jim Wilson.

PROF. WILSON:  I just wanted to reinforce what Paul said earlier on, that in this chapter, in addition to spelling out the ethical concerns with a paragraph or two of explanation, we should spell out the advantages of the assisted reproduction and use the case of Tay-Sachs disease.

There may be other cases as well that we have to make clear from the first, that the reason that there are a million children in the world born with this is that a large number of parents, roughly 2 million, think it is a good idea.

And we have to explain some reasons why it simply may not be a good idea because they have a child, but it also may involve other reasons.  And this comes back, of course, when we talk about the power to screen and select, which is the subject of the next chapter.

So it may be in either chapter, but I simply wanted to reinforce his concern that it be there   Let me also add that I have failed to observe the extraordinary accomplishment of Carter and the staff in producing this document.

I find it remarkable.  I have learned something on every page, and the fact that they did it in just a few months suggests to me what I long believed.  That most people take too long to finish their Ph.D. theses and could do it a lot faster if you work hard. 

CHAIRMAN KASS:  Thank you, Jim.  Anything else on this, on the first section, Section 1?  Janet.

DR. ROWLEY:  I just thought it would be helpful, because there is an enormous amount of information in this chapter, and it is both government and non-governmental, et cetera, but if you could figure out a way to put it in some tabular form.

You obviously made your headings government and non-government, and then I would leave it to you to figure out what the headings would be, because you have the headings here when you describe each one of these, but I think that is giving people an overview, and that would be extremely helpful.

CHAIRMAN KASS:  Not for today on this chapter, but — and I think that Rebecca's point is very well taken, that this concept of the well-being of the child needs to be unpacked and in its various aspects discussed.

But I think in keeping with the suggestion that while we are not at the moment advocating regulation, a new regulation of this or that, but it might be worth highlighting which of the things in this chapter are causes of particular concern, and from my own reading, I am struck by the absence of knowledge of the consequences of ICSI as something that one would want to call attention to.

The business about multiple pregnancies, prematurity, and those kinds of things which at least ought to be studied and addressed, and somebody ought to take responsibility for looking into those matters, because those that have at least to do with the health aspects of the well-being of the children-to-be, and I think that there is more that we need to know about that.

But I think we should be looking through these chapters for the particular things that we might want to highlight, as well as the larger abstract and general points.  Janet. 

PROF. WILSON:  Well, I think in that regard that as was brought up by some of the speakers at earlier meetings, I think the January-February meeting, much of this is driven by the nature of the funding of our health care system. 

So that if you want to have success, the way to have success is to implant multiple embryos, and Europeans with a different form of health are don't implants ore than two embryos.

So I think that one of the things that concerns or that I think we have to be careful of is not to fault the clinics, though they certainly have their share, for doing things that are in fact almost forced upon them by the way our health care system is financed.

And so if we criticize them for doing something which is, or to point out areas of concern, I think that where there are obvious reasons for them to practice the way they do that are in a sense beyond their control, we ought to acknowledge that they are not just doing this for a frivolous reason.

And I think that we have to be very careful in these kinds of matters.

CHAIRMAN KASS:  The second chapter, page 71 ...

PROF. WILSON:  I am in the chapter, but not right on that particular page, and I think as Paul and Jim also noted, my own comments related to page — and particularly page 66, there aren't — there isn't anything in this that really does speak to the enormous benefits that have come from some form of PGD,and so I think for balance — and this is a point that Paul raised earlier.

And I think this is really the section in which we should acknowledge that appropriately.  And as long as I have the microphone, in the middle of page 66, I am sure that we are all aware, because it was a well-publicized case, of a family having a child that served as a bone marrow transplant donor for a sister with leukemia.

You know, out of a hundred-thousand or so children born with assisted reproductive technology, this is maybe one out of a hundred-thousand.  So I think that you can cite this, but also indicate it is a rare example.

So it is certainly an example of a source of concern, but a pretty rare example as well. 

CHAIRMAN KASS:  Bill Hurlbut.

DR. HURLBUT:  Well, I want to make two conflicting comments on this question of PGD.  I think we have to be a little careful not to over-exaggerate its implications.  In order to select for even a Mendelian trait, where there is, let's say, a 1-in-2 chance that the given embryo might have the trait, you have to have two embryos.

To select for two traits, you need to have four embryos, and for the selection for a trait that has more than one allele, you need to multiply that out geometrically.

The point being that although there are 10-to-15,000 Mendelian traits described thus far, and there will no doubt be many more added, these are mostly very rare conditions and disorders, and so forth.

I mean, there are a few things like red hair and so forth.  But not issues of great magnitude.  Most of what we are really interested in are what are called multi-trait loci, where many genes contribute to a single phenotypic trait.

And therefore because of the number of genes involved, it is not going to be possible given our current state of production of embryos, to have enough embryos to sort through to get much effect on the traits.

I think that is an extremely important thing to realize.  That to date there have been — Mark Hughes told me I think 6,000 efforts to do a PGD, and somewhere between 1-and-2,000 children born from this I think is the figure.

I don't think that this is going to be a widespread phenomena.  There will be a lot of PGD for chromosomal problems with FISH and so forth.  So that is true.  Now that is the one side.

But I — and I know that this sounds very futuristic, but let's at least think forward into the possibilities here.  There are several possible scenarios that might emerge if this technology advances the way it seems to be going.

If we could develop a source of abundant oocytes, then — and which is really being worked on for a variety of reasons, including the desire to do cloning for biomedical research so we don't have to harvest them 12 to 15 at a time through superovulation, if we could induce fetal oocytes to maturation, or perhaps use ES cells to generate oocytes, and there is a variety of other possibilities.

There is ovarian biopsy that has been done in mice to greatly multiply the number of oocytes.  If this could be done, suppose you could produce an abundance of oocytes. 

Then theoretically you could for any given desired progeny fertilize a hundred, or a thousand occytes, and produce maybe — I wouldn't be surprised if you could produce an automated PGD system.

And then you really could shift through embryos and it could turn out that large traits, multi-trait loci converging into large and significant traits related to things like personably profiles and appearance, and so forth, the things that we really would want to select for, they might turn out to be transmitted in blocks, cassettes of genes.

And with the HAPMAP (phonetic) for example, we are going to learn more about how blocks are transmitted.  It turns out that when there is a reshuffling of genes in recombination that takes place during meiosis that it is not a big reshuffling like a deck of cards.

A given chromosome only recombines one or two times, and there are principles along which it does, and they only recombine in specific places on the genome as a general rule.

This means that gene blocks are sorted and resorted together.  We could develop technologies where we could follow the gene blocks from the mother or the father, and preferentially select embryos based on a set of those and where they came from. 

So I think on the one hand we should not over-exaggerate it in the short run.  In the longer run, I think we should be very aware of it.  This could be quite a transforming technology, in terms of how reproduction is greeted.

And, well, maybe that suffices.  I don't know if that is a helpful comment, but it does point to the fact that this technology is moving us increasingly away from what we think of as the natural way of reproduction.

CHAIRMAN KASS:  Jim.

PROF. WILSON:  This may be the chapter in which we want to mention what you and I have discussed privately on other occasions, which is the changing sex ratios that can be identified in the population, and the effect of sex selection as a way of increasing the sex ratio.

That is to say producing many more male children than female children.  I do not see whether that has any policy significance, because let us assume that Chinese-American families prefer male children. 

And let's assume that they go for sex selection.  And let's assume they get many more male children than others, and they develop a sex ratio of 130 or 140 to 100. 

This has important social consequences, but I don't quite see how the government can do anything about it, because if the government were to regulate in this area, has to do it on a case-by-case basis.  And you can't say, well, we are not going to allow certain ethnic groups to practice sex selection.

But I think the facts are sufficiently important that noticing them here, that there are these large consequences of sex selection, might be informative to people.

I guess getting the information out is all that I am interested in.  I don't have any policy purposes, but it may be worth mentioning. 

CHAIRMAN KASS:  Paul.

DR. MCHUGH:  I think this is a good chapter, and it is very interesting.  Again, I am learning a lot in this process.  Again, I think it is important to represent the new discovery also from its benefits, and I have mentioned one of the benefits.

Of course, a benefit that is not mentioned here is the benefit of avoiding an abortion, and the experience of a pregnancy that is still uncommitted, and that is a terrible experience for a woman.

And I have not made up my mind completely about PGD, but one of the things that would spare them is this kind of later life experience, particularly people with Tay-Sachs and things of that sort and that experience.  I think it should be mentioned.

CHAIRMAN KASS:  Speaking for myself, I guess I understand and see PGD really as an extension of prenatal diagnosis, with some of the advantages that Paul has just alluded to, especially if one is dealing with these devastating diseases.

But there are significant differences between weeding out and selecting in, and one sort of — and not exactly trivial, but generally not noticed difference is that in order to make sure that you have got an embryo that passes muster, that embryo has to be subjected to testing.

And if there is some risk in this blastomere biopsy about which we don't know yet know enough, that in order to make sure that you get a healthier child, you subject that healthy child to risks that he would not have faced had he wound up in utero, and you would have been able to make the diagnosis through pre-natal diagnosis later on, though there would be the problem of abortion.

So I think it is terribly important before this gets from 2,000 children to 50,999 or a hundred, that someone begin to pay attention to prospectively to what the consequences are just with the technique of finding out.

Some of my friends tell me, look, this is just like embryo splitting, where you could get twins, and an embryo falls apart in the two, and it is not a big deal.

But I am not so sure, and that happens spontaneously, and this happens by manipulation, and I would like to be reassured before I saw this become a monumental practice, whatever scale it reaches on its own.

Also, I guess though I understand the reasons for private choice of sex selection, I don't think I am quite happy allowing that to be decided, and I would not be happy to allow enhancement uses of selection.

Now, to be simply deciding on the consumer laissez-faire model, unless society has had some kind of discussion of it, and decided that that is the least bad way to do this, because governmental interference, et cetera, et cetera, would be regarded or would in fact be too much of an intrusion.

But it seems to me that a community could say, and other communities have said, and in fact I think the American Medical Association has declared, that the use of this, to engage in sex selection, save for the disease related cases, that should be out.

And it seems to me not out of the question that this could be a matter of public policy, but I think in the first instance that I would agree with Jim.  I would like to be sure that somebody is paying attention to what is being done in this area, and not just in ethics groups, but in lots of places.

We ought to know about this, and we ought to know whether it is rising, and I myself would not mind seeing a debate as to whether this is something that society wants to go ahead with or not.

And similarly on the question of the uses of PGD or other genetic capacities, to go beyond the prevention of these severe diseases.  I mean, these are not things that I myself think should simply be decided accidentally and with nobody paying attention.

And we find out 20 years from now that it is now part of routine medical practice, and it is in that limited sense too late.  So I regard the present situation as unsettling, and what to do about it I think requires a lot more discussion if there is anything to be done about it.

But I find this chapter persuasive in this presentation, though I think the balance that people have called for is absolutely necessary if it is to be a proper document.  Janet.

DR. ROWLEY:  Of course, one could take the contrarian point of view, that if you really had major distortions of the sex ratio in a place like India, that the status of women might change dramatically, and that in fact you would have men paying women's families dowries rather than the reverse, and that might be or actually have some benefit.

CHAIRMAN KASS:  Hear, hear.  Frank, did you want anything on this — on the chapter on the capacity to modify traits, and actually concludes that none of this is on the intermediate horizon, and that in fact — this is a quiet area, because nobody is going this, and in any case, the RAC and the FDA have more or less stood in the wy of things going past this for now.

And this seems to be a topic, at least according to the document, that is worth our discussing only to set to the side at least for the time being.  Is that a fair assessment?  Bill.

DR. HURLBUT:  I think something is missing in the document refers to the qualities in the procedure and in the media that influences outcomes that are not  DNA genetics, but in a sense they are cytoplasmic factors in genetics after all.  Gene expression and so forth.

It is well known that the medium affects the outcome, and so we should include something about that.  I want to actually make a comment to your previous comment.  One of the interesting things about this whole realm is not just the way PGD might alter and even introduce its own form of distortion or pathology.

But from the very, very most foundational and accepted practices, ART introduces that subtle question of how much risk and how much disruption of normal procreation is acceptable.

And as I reflected on the question of Federal regulation, and if we would recommend any, I kept coming back to the question of how do you balance out individual rights to procreation against dangers implicit in a technological, technologically assisted procreation.

And that is a really difficult and subtle question, because if this were a drug or a device that had a 50 percent chance of causing a problem, we would not accept it — for example, a major congenital malformation, but we will accept it, for example, if a person with ectodactyli, where you have a deformity of the hands and feet.

If you have a 50 percent chance of that, we do not interfere with the person procreating a autosomal dominant trait.  And it strikes me that from the very beginning that it is well known that ART results in different cleavage rates than the natural.

The embryo at every stage has fewer cells than the natural, and it is known that it produces babies statistically anyway with lower birth weight, plus the morbidity and mortality of multiple tasks.

We are looking at a technology here that does have its downsides from its most conventional use, and not just from its most extended use.  And that raises a strange question of the natural versus the unnatural, and how much morbidity and mortality we are going to introduce technologically.

And whether or not there is a difference between what you might call natural pathology, and artificially created pathology, and who has a right to decide.

I think those are the kind of issues that we need to contend with here, in-part. 

CHAIRMAN KASS:  Gil, a comment to that?

PROF. MEILAENDER:  This is not precisely on what Bill had to say, but just about the chapter.  And I actually think that there is something important about this chapter, and as opposed to just saying or concluding that there is not much. 

And I think it has to do though with what we think this document ought to try to accomplish.  The fact of the matter is that this is the one chapter that defines that there is quite a bit of regulation in place right now with respect to things that are happening, and there is a reason for that.

It is because the things that are talked about in this chapter fall under the rubric of research, or experimentation.  And in the not-that-distant pass, some very bad things happened in the realm of experimentation.

And indeed one of the chief energizing concerns in the rise of the bioethics movement had to do precisely with experimentation.  So that there is kind of a lesson to be learned from this chapter.  Namely, that some very bad things can in fact happen.

And that that is why when you look at this chapter, you find that we are out of sync with the rest of the paper, and lo and behold, there is a lot in place.  Well, there is a lot in place for a reason, and I just think that we need to call that to mind.

CHAIRMAN KASS:  Jim Wilson.

PROF. WILSON:  On page 76 of this chapter, under the subhead of "Enhanced Control Over Children," there is some language here which I think is premature.  It says, "A child who is created to certain specifications is" — and not maybe — "but is more of an artifact than a child who is merely selected for his or her existing characteristics."

In this way, genetic modification can convert "procreation to manufacture."  Well, that is an conceivable hypothesis, but a child that is born to a woman after 9 months of pregnancy, whatever efforts were made to modify the traits in advance, is going to be regarded by the mother and I hope the father as a child, and not as an artifact.

And not as something that was manufactured.  So that if you want to raise this as a tentative possibility, that is well and good, and we will have to find out whether that happens should this process ever become elaborated.

But I think it is premature to say with such  confidence that we are going to manufacture children or turn them into artifacts simply because there will be enhanced control over the genetic material at the moment of implantation.

CHAIRMAN KASS:  To this point? 

PROF. GEORGE:  Leon, it might be dealing with a problem like the one that Jim has put his finger on here, that it is important to distinguish — and it could be relatively easily done, two distinct senses in which the problem of treating procreation as a form of manufacture could be addressed.

One would be the psychological question, and how will children be treated by parents and others when they are brought into being under these terms.  The other would be the philosophical analysis of the attitudes that are embodied in the decision to proceed in this way.

Now, that would be much more subject to dispute, but there are competing points of view about this, and there is actually a literature about it.  And there would not be any reason in principle why both issues couldn't be raised, the philosophical one and the psychological one.

The psychological one can be treated as a matter of hypothesis, subject to verification or falsification.  The other has to be treated in a more philosophical mode.

CHAIRMAN KASS:  Okay.  Actually, I would like before we move to the chapter on research just to add one other thing that is worth underlining, although it is not — it is backward looking in the second section, and that has to do with some of the implications to screen and select for the attitudes towards the abnormals who escape detection. 

It is a problem that we — it has been around for a long time, since the beginning of prenatal diagnosis, and I think almost everybody has either known or had the experience, or heard of the experience of women who give birth to, let's say, children with Down's syndrome or something like that.

And then they face the question why didn't you have an amnio.  And we are — we have not really seen the full scope of the kinds of distinctions now increasingly to be possible in the light of the vastly increased numbers from which we can screen.

And I think on the question of discrimination, not just in employment and those sorts of things where we have leverage, but just in terms of the general attitude.

The more and more we take screening even for health reasons for granted, the more and more one is inclined to say that there are — and although no one would call it that, that there are inferiors amongst us who, if only the testing had been better, would not be allowed to be here.

And I don't know that this is a matter for regulation either.  But the question of the equal dignity of human persons, regardless of their genetic limitations and disease limitations as I think a value of considerable importance to be upheld and at least put on the table, though again it is not clear to me what follows from that.

But I don't think that many people are paying attention to this aspect of what it means actually to go to go forward in the pursuit of these very serious diseases with increased powers of screening.

And I like the fact that the document deals with that, and I would like to underscore it.  Paul.

DR. MCHUGH:  If I could just amplify that for you, and increase the concern, and namely that there are screening methods now that have such large false-positives that that — and particularly the triple testing for potential Down's syndrome and therefore encouraging people to have amniocentesis, that doctors are now shocked with the burden that all pregnancies put on women, particularly when this triple test comes up positive, even — and by the way.

Even when they go and have an amniocentesis, such women, until their baby appears, a normal baby, is in a state of distress about how that test went so wrong, and how that test indicated to them that maybe there is something wrong with their children.

And so part of the problem of our present work

— you know, in France, they insist that everybody has these triple tests, and I can vouch for the psychological burden that many women with perfectly normal babies have after they have gotten this result, and hear from genetic counselors that they have the classical sign for Down's syndrome when they are carrying a perfectly normal baby.

And the odds — the only thing that has happened is their odds have changed from let's say 1-in-600 of having a Down's syndrome child, to having 1-in-300, or 1-in-200.

And that is so alarming to women that it carries on from pregnancy to pregnancy, and it is a real burden.

CHAIRMAN KASS:  Let's turn to the research section of this.  In effect, silence.  Here — let me just underscore what I thought was a very interesting and rich exchange in the second panel yesterday, when Michael Sandel put questions to Richard Doerflinger on the subject of whether one could consider regulatory activities in an area where one had grave doubts about its propriety in the first place.

And up until this point it seemed or has always seemed to me that this is one of these all or nothing propositions, where you either buy a big package like the British or the Canadian model, or you do nothing at all.

But it does seem to me that if I understood Richard Doerflinger's remarks that maybe we ourselves ought to be at least more flexible in our thinking as we think about this area of research.

And even if this council couldn't reach an agreement on the whole matter here, there might be some things hat are worth calling attention to in the absence of something more comprehensive. 

I think that wa a rather liberating comment for our consideration, and I don't know what the rest of you think about that, but I thought that was really one of the golden moments of yesterday's meeting.  Is that all right, Robby?

PROF. GEORGE:  Yes.  Yes, I agree with that.

DR. ROWLEY:  Could I raise a question about some of the concepts on page 88 and 89?  At the bottom, it is under the heading, "Ethics."  And I think where we talk about the destruction of nascent human life.

Non-therapeutic embryo research necessarily involves the use and destruction of nascent human life.  This of course if an area that we have discussed several times; that the likelihood that a particular embryo will actually lead to a successful pregnancy is less than 50 percent.

And I think that there are many people who figure that it is in the neighborhood of 20 to 30 percent that a particular embryo will in fact lead to nascent human life.

So I think to equate every embryo with a living fetus and child is probably biologically incorrect, and I think that might be considered.  And then on page 89, there is regarding and treating nascent human life as a mere means, and it goes on to point that it coarsen sensibility, and lead to a devaluation of life.

This is sort of the slippery slope argument that I thought was quite effectively discredited by Jim Wilson a number of meetings ago, and I think that maybe some of that language might be reconsidered.

CHAIRMAN KASS:  Any response to this?  Gil.

PROF. MEILAENDER:  This raises again for me just he question of what we hope to accomplish in this paper, and I thought at the outset that it was simply to chronicle what the current status of regulation is, and I myself still think that it should do that in a rather modest sort of way, with maybe less conclusion in fact rather than more.

But it is just a note that obviously if we left this discussion, but altered the language in the direction that Janet would prefer, then I will ask to have it changed the next time around.

So we are going to have to find a way to deal with the regulation question that does not require us to wage those arguments again.  Or we are going to have to kind of recast our thought about what we are doing.

CHAIRMAN KASS:  And let me say — I mean, maybe the language can be moved slightly one way or the other, but I think — and here I thought the exchange between I guess Gil and Maxine Singer yesterday was illuminating. 

However people come out on the question of whether such research is licit or not, I think most people recognize that this really is a moral issue, and the report by the Embryo Research Panel at the NIH, and even the National Academy's own document talks about how the early embryo is deserving of some special respect.

And that means that even if you are going to use it and destroy it, you somehow treat it as something other than mere tissue.  And I don't see any way around, apart from sort of defining this problem out of existence, to say that there really is a moral concern here on how much weight to give it, and whether this is one of these matters of principle or whether it is one of these matters of balancing and people disagree about that.

But if this weren't a moral issue, life would be very simple.  Jim.

PROF. WILSON:  I think that dealing with human life, even basic human life, whatever the probabilities that it will become, an implanted embryo is a moral issue.  I have no doubt about that.  I have a difference between me and some members of the council as to how far we go in protecting it.

Could we leave it with that sentence intact and simply delete the sentence that says, "It could coarsen sensibilities and lead to a devaluation of life in other contexts." 

Which to me is a hypothesis which I find implausible, and some people may be believe it, but it does not detract from the fact that it is a moral issue.  It is that last sentence that I think strikes me as bad social science.

CHAIRMAN KASS:  Bill, to this or to somewhere else?

DR. HURLBUT:  In line with this.  This introduces a very complex question, but if we say — even if we take the most stringent definition of the dignity of human life as being the organism in process, and take it all the way back to the zygote, it then raises a second question of is there a sense in which some studies could be done on disordered forms of fertilization.

For example, only three kinds of aneuploidy involving trisomies are compatible with human life.  And I raise this because I now that this is a discussion that is going on in the scientific community, where the question has been raised is if you detect an aneuploidy with PGD, can you then use the embryo, which could never go on to form a full human person, or not even very far in th trajectory of embryologic development, but can you then use it to study some measure of normal process.

And I don't want to sound too contentious, but I think this council would do well at this stage in the development of the science of developmental biology to try to define more clearly what the moral boundary is here of what it would be moral to experiment on and what it wouldn't be by the most stringent criteria.

If we could do that, we would put up a fence that the scientists could play, too, instead of being afraid to even get close to it, and that would open up possibilities in science.

On the other hand, I am not trying to introduce horror scenarios, where you take someone who is almost a human, and manipulate it.  It is just that fertilization and some of the early cell dynamics could be studied in the absence of a reasonable generative potential.

CHAIRMAN KASS:  Bill May.

DR. MAY:  I hesitate to revisit what we discussed at greater length earlier, but I think Michael and Jim Wilson, and I, at the point of earlier decisions, associated myself with their view with regard to the special respect due the embryo.  It doesn't have the kind of claim that would thwart research that could deal with disease.

On the other hand, it isn't nothing and I think that Jim used the phrase intermediate status, or somebody did.  And in my brief note on an earlier document suggested that if it has that kind of status, it isn't simply a resource at our disposition. 

It is in a sense a human source and not simply a resource at our total disposition.  And though its intermediate status might allow for the conduct of research, it has implications regulating and curbing that research, and the sole illustration given of that at the end of this document is about should not be cultivated beyond 14 days development.

The point that I made in my brief addition to the original document is if you understand it to be not just a fingernail and so forth, but a kind of intermediate status, it has implications for regulation, not simply on the terms and conditions under which you conduct the research, but the ultimate distribution of the fruits of that research.

Not just the generation of the good, but the distribution of that good.  If we remove from life the pre-implanted embryo and conduct that research on it, we have not removed it from the circle of human indebtedness. 

And the form of that indebtedness includes not simply the limits on the conduct of the research, but honoring that indebtedness to make sure that it reaches all in need, and I think here maybe all that would need to be indicated is that the professional societies agree to the notion that it should not be cultivated beyond 14 days development and so forth.

But so far we have tended to be silent on the question of the outcomes in the uses of that research, instead of it simply being captured by venture capitalists.

CHAIRMAN KASS:  Alfonso, please

DR. GÓMEZ-LOBO:  Okay.  I am afraid that we are back to a very central topic, the status of the embryo actually, although there is a sense of what you wanted to be.

CHAIRMAN KASS:  This is where it belongs.  I mean, this is where he is.

DR. GÓMEZ-LOBO:  Well, I would like to make the following remarks.  The questions of probability usually have very little or no bearing on moral questions. 

For instance, the probability of a child in a certain country in Africa to reach adulthood is 50 percent.  That does not affect in the least the respect that we owe to that child.  So probabilities, nature, probabilities a lot of times have to do with external conditions. 

Sometimes, for instance, the impossibility of an individual reaching adulthood have to do with the facts that there is insufficient food provided in that country.

Now, with regard to the early embryo, there is of course two questions of probability.  One is the question of whether a certain organism, if we may call it so, generated is viable or not, and gets eliminated.

And of course we have heard over and over again that a very large percentage gets eliminated.  But the embryo that does not get eliminated, and that is biologically viable, does constitute an organism which is co-extensive with what we, each of us, was.

I mean, we all started off if we are not twins as one embryo.  So there is a question of probability and the uncertainty of determining what is what at that early stage, and which has no more bearing it seems to me on the ones that do.

And then there is the probability of that viable embryo of surviving, and this may also be due to external conditions.  Of course, if an in vitro embryo is not implanted, it is not going to survive.

So the probabilities would be close to nil.  But the real consideration from a moral point of view is what kind of a being do we have there.  What is the nature of an embryo in the early stages, and it is from that nature that we are going to derive our inferences with regard to how it should be treated it seems to me.

So I would certainly keep the expression of nascent human life, because it seems to me that we are worried about those embryos are viable, and that may be subject to destruction in research. 

CHAIRMAN KASS:  I am slightly mischievously moved to ask a question, and then I think we have time for the public session.  But just briefly, given your moral views of this matter, if someone were to suggest at the present time that there seems to be — there is disagreement about lots of things, but there seems to be an agreement even in the scientific community — and this was an exchange between Robby George and Michael Werner yesterday about boundaries, right?

If there was an agreement today which said human embryo research may not be conducted past, let's say, 10 days, or 14 days, or what have you.  Would you regard assent to such a rule of practice, or even a law — and this is a hypothetical, but would you regard assent to that to being complicit in the practice, or would you regard that as a useful boundary while the debate about other things should go forward?

Now, this is sort of the test on whether there is some kind of room for maneuver on setting some kinds of guidelines for embryo research.  Is that in effect to endorse it? 

We are not talking about Federal funding now.  We are simply saying —

DR. GÓMEZ-LOBO:  I have consulted my own conscience quite a number of times on this, and it seems to me irrational, that is, inconsistent, to hold that human dignity is co-extensive with human life.

And then proceed to say, well, there is a fragment in time in that human life when dignity does not hold, which is what I would be required to say.  Now, I was a couple of weeks ago in Berlin at a conference, and I heard Professor Jean-Claude Renard and a professor that he was going to talk with, Rudolph Jaenisch, say quite clearly, well, a human life starts at fertilization.

So I would have my deep in my conscience, I would have to insist that we not experiment with live human embryos even before 14 days.

CHAIRMAN KASS:  Gil.

PROF. MEILAENDER:  Just a slightly different comment, but still directed to your query, and simply to say that I interpreted the exchange between Robby George and Michael — whatever his name was —

CHAIRMAN KASS:  Werner.

PROF. MEILAENDER:  Werner — somewhat differently yesterday.  I interpreted it to mean that if one held Alfonso's view that one would be fool hardy to suppose that the 14 days was anything other than a moving line, depending on what was possible. 

So in addition to the question about complicity, there is a question about —

CHAIRMAN KASS:  About prudence.

PROF. MEILAENDER:  Yes.

CHAIRMAN KASS:  Right.  All right.  Frank, a last comment on this, and then we will have a public session, please.  I guess Rebecca wants to say something, too.

PROF. FUKUYAMA:  Are we going to get a chance to talk about the future work program and where we go from here?

CHAIRMAN KASS:  I would like to do that.

PROF. FUKUYAMA:  Then I will hold off.

CHAIRMAN KASS:  Then let's take a few minutes on it.  Rebecca, do you want a quick comment on this?

PROF. DRESSER:  I will hold off.

CHAIRMAN KASS:  Let me see if I can — I think that something of the summary offered at the end of the first session has been supplemented by more specific comments, section by section.

There are — I am not sure that I can get complete agreement as to whether mere description without even evaluation is more to be preferred, or a full diagnosis with comment is more to be preferred.

I think I hear more for the latter, though Gil has a certain reservation.  It does seem to me that short of fixing the document and making some suggestions on how to improve it in detail, I think what we need is first of all a clear articulation of the particular goods that are at stake here and more fully described.

The balance matter is already addressed, and to be taken care of.  I think a search for particular areas of concern in existing practice that deserves special notice or attention, and attention to things which are — if not — things which are coming in, where one wants to get prospective information or areas where we would request additional knowledge and oversight, and monitoring, just to flag those places.

But from the point of view of taking things further, it seems to me that maybe some kind of general discussion of the strengths and weaknesses of various alternatives to go beyond where we are, and arguments for and arguments against, might be in order.

But maybe we are not ready for such further staff work.  What do people think?  Frank.

PROF. FUKUYAMA:  Well, in terms of what we do going forward, first of all, it depends a little bit on whether the mandate of this council gets extended.  You know, if we sunset this year, then I think this is a nice document, but there is no point in doing this, because this is really a big amount of work that we are embarking in.

Assuming that we do in some way get extended, I think that what the staff needs to do is to supplement this excellent beginning with the outlining of several different options, beginning with do nothing, and going to various alternative institutional forms that may draw on some other national models — the Canadian or British ones that we have heard about already in this council — simply as a further point of discussion.

Because I think that without something concrete, where the options are laid out fairly precisely, it is going to be a fairly shapeless discussion, and I think the staff is in a good position to do something like that.

But I do want to make a general caution about our proceeding — you know, if we take a route like this down this road, because there is going to be I think intense suspicion from many, many quarters about what we are up to, and I think that will be quite reasonable.

Some of it was laid out in the document already, and a lot of it really does have to do with abortion politics, because for example, the various suggestion that you might want to look at the regulation of the ART industry, well, that immediately raise a red flag with many people as I think was indicated by the testimony yesterday that, well, this is a bunch of pro life people that want to protect embryos, and that is the basic motive for sticking the camel's nose under this particular tent.

Conversely, it is also possible if you take the pro life position that you can see this whole regulatory exercise as a means of facilitating further change in stem cell, embryo research as is the case with the HFEA in Britain, where actually the existence of that regulatory body does facilitate research in this area.

And again this has been a concern that has been raised by Alfonso, among others, about our proceeding down this road.  And I don't see any way of allaying these fears other  than by proceeding with complete transparency.

And transparency doesn't mean just hortatory saying, well, we don't have a secret agenda here.  I think that procedurally it has got to be implemented in a certain way. 

Now, there is a negative model, and there is a couple of negative models, and I would say Jimmy Carter's energy proposals, and in the wake of a second oil crisis, and the kind of Hillary Clinton approach to health care reform in the first Clinton Administration are good negative models of what we don't want to do.

Which is to say that to regard this exercise as a kind of technocratic bunch of experts on regulation coming together and writing the optimal public policy outcome in camera, and then unveiling it at a certain moment and saying, well, look.  This is what we experts think. 

And I think that procedurally what you have got to do is create a process by which all the stakeholders get to say their peace about this, and that involves much more than the two panels we had yesterday.  I think this has to be an ongoing process.

If you look at both the Warnock Commission and Patricia Baird's commission that preceded the Canadian initiative, this was actually a very ambitious undertaking.

It was a multi-year effort, where they had focus groups, town hall meetings, public testimony from a lot of different people.  Now, we obviously don't have the budget or the mandate to engage in that kind of an exercise, but I think that the more of that kind of thing that we do the better, because that I think is the only guarantee that people will have that we are not about to foist something on people that doesn't reflect full discussion.

And for my part, I quite honestly don't know what the answer to the — I mean, I think Carter has raised in this document some excellent points about the weaknesses of the current system.

But I am genuinely agnostic whether there is a way of moving beyond the current system to do some results which will actually be better.  That is an open question.

And so that is my suggestion for proceeding; that the staff be instructed now to fix the issues that were raised in the discussion today, and in this document, but to actually start the process of drafting an options paper that will serve as a basis for discussion later on, again dependent on the extension of the mandate of this council.

And that we furthermore work on a kind of a procedural set of guidelines for how we bring in outsiders to help us think through this set of issues.

CHAIRMAN KASS:  A comment to that?  Gil Meilaender.

PROF. MEILAENDER:  Let me just say a little bit about to amplify perhaps my too cryptic comment earlier about what I thought the document was about, and this in part really agrees with some of what Frank said, though he has got a more kind of ambitious program at work, too.

As I think about the document and our discussion of it, the list of goods at stake was actually it seemed to me rather complete, and I didn't hear anybody question the list of goods.

I am not persuaded that they need some kind of great amplification in fact.  Where we continually run into problems is on the ethical concerns discussion.  If I were doing it, and I would have to think more about exactly how to do it, but I would get rid of the discussion of ethical concerns.

And the note of conclusions in which we are constantly jockeying over the language to see if it is formulate in a way that tilts one direction rather than another.

I would outline the regulatory system, and whatever is in place in these various areas, and then at the end I would discuss as straightforwardedly as possible — and I think straightforwardness is essential — the various possible kinds of responses that one might make to that.

We would have to see then whether any consensus of opinion goes behind any of those, and I don't know whether it would or not.  There might be opinion behind to gather more information, for instance.

But it just seems to me that if in the main body of it we got rid of the stuff that has us constantly jockeying over buried normative possibilities, and just let those come out in the different kinds of options one might recommend in the face of what the review of the current system had shown, we might have something that was straightforward, and that was clear and useful, and that everyone could endorse.

CHAIRMAN KASS:  Rebecca.

PROF. DRESSER:  I think that it is helpful to try to clarify ethical considerations because I think that what goes on often is, oh, my god, all these things are really risky and dangerous, but there isn't specification.

And so I would agree that it is difficult to figure out language, but I think that is the contribution that we could make.  I think that we did that in the cloning report and I think that it was worthwhile. 

And also I don't think that you would be avoiding it by waiting until you try to put this into the options, because I think you would run into the same sort of discussions.  So for what that is worth.

The other thing is that maybe there is a less ambitious agenda that we could start with that goes some steps along what Frank was saying, which is to have a chapter or two talking about different mechanisms of regulation. 

Everything — and that should include things such as education, financial incentives, even tax policy.  I mean, there are all these different ways that are used to shape behavior. 

And we ought to at least sort of set them out briefly.  But then throw out some options.  Not every possible option.  So, for example, one option would be the FDA should cover certain novel infertility techniques or procedures, and we might get into — I mean, obviously there would be a lot of issues there.  But in terms of treating them as new drugs and devices, they should go through the same kind of safety testing that other innovations do.

Another option would be maybe there should be some sort of standing advisory body similar to us where at the Federal level people could at least on an ongoing basis try to think through some of these more broad concerns, such as family, and dignity, and child protection, and respect.

And just to say, you know, here is some thinking, and not necessarily to impose on anyone, because obviously that is not something that the FDA is equipped to handle, and I think that it might be difficult to include those considerations.

So another option would be model laws for States, since States do have the authority to regulate medical practice in general in our country, and should there be some sort of agency set-up to write some model laws, specifically in this area that States could pick up if they wanted to.

So not necessarily a comprehensive set of options, but here are some possible options.  Here would be a good size, the bad size.  

CHAIRMAN KASS:  Gil.

PROF. MEILAENDER:  Rebecca, I don't want to ignore the ethical questions.  I want to find a way to discuss those in the context where they can be discussed straightforwardly, rather than sort of in the indirect way that always raises questions of do we really have a neutral document or not.

That seems to me by letting those rise in different possible regulatory schemes that one might or might not see in a more straightforward way.  I think the reason that in Section 3 that the document finds a good bit of regulation is as I said for historical reasons.

And for those historical reasons, there is in fact a bright line, the principle of informed consent.  And with that bright line, you can proceed to regulate.  The reason we have so much trouble finding it in these areas is because we don't have an agreed bright line.  That is exactly what we are arguing over.

And it seems to me that we ought to just let that fact emerge rather than sort of finessing it in ways that don't really make anybody happy.

CHAIRMAN KASS:  Anyone else on the question of proceeding?  Let me suggest that there are a variety of suggestions not yet talked through here, that council charge the staff with letting you know within the next two weeks exactly what these next steps are going to be.

Part of our mandate we know.  The question of what — I mean, you see, Frank's comment is partly contingent upon the future, and at least in my own thinking, whatever longer term thing this council would do in this area, there would be some merit in this two year term, and this our two year term, of putting out what we can on the current state of practice.

And some suggestions of possible options that could be pursued, and the strengths and weaknesses of doing so, and also if there are areas of common agreement on some specifics.

And there is no harm if we have got consensus on certain kinds of things, and no reason not to flag those for our attention if we have some specific recommendations to offer.

But I would think that a realistic goal certainly for this fall would be an improvement of this document, coupled with one or another of these plans for how to think beyond where we now are to the alternative ways of improving on the present situation.

But we certainly can't in the time between now and the end of this Executive Order, and that we will know sometime before too long on what the future might he.

But there is no way in the world that we could start any of these large processes, the sort that — and assuming we want to do that.  It is not clear that we can undertake that, and so I think a modest contribution in this area, with some suggestions of alternatives, and the strengths and weaknesses, and the strengths and weaknesses of doing nothing, are I think a useful contribution to people's thought about this, at least as a short term goal.

Jim Wilson reminds me that we didn't say anything about the commerce section.  It's not that I have an aversion to commerce, but let's have a brief comment on that if we have them, and then we will have the public comments, and we will be done on time.

PROF. WILSON:  I have three comments.  First, the title.  Certainly it should be called Commerce. Commodification I think, is a mistake.  Part of my decades long struggle with Marxist language leads me to resist the notion of commodification.

Besides, it implies a judgment that commerce leads to commodification when in fact we have no evidence to support that.  So, commerce should be the title.

On page 107, "the buying and selling of gametes raises ethical concerns" possibly that this will lead to commodification of reproductive tissue that "might diminish respect for procreation."  This is unexplained, and I find it implausible.

"Others additionally claim that it may taint the otherwise altruistic motivations that lead individuals to denote their gametes," when in fact a large number are paid to do so.  We even pay people to donate blood.

It seems to me that these come too close to slogans to really be considered ethical concerns.  And then finally on page 108 to 109, the bottom of 108 and 109, we seem to be endorsing price control in this area.

The ASRM says that maybe you can pay $4,200 for an oocyte, and possibly $5,000 if we justify it, but we should not pay $10,000 or more.  I don't know what basis they made these judgments.  It strikes me as completely implausible.

If there is a case for price control in gametes that is better than the argument for rent control in New York City, I have not heard it.

CHAIRMAN KASS:  Any other comments?  Good.  Thank you all for very careful attention to the document, and thank you, Carter, and the rest of the staff for getting us off to a very good start.

We will be in touch with council members on a plan of work, and we will offer you some assignments, too.  And also please send in any specific further details along the lines that comments have been made.




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