The President's Council on Bioethics click here to skip navigation

 

Meeting Transcript
June 13, 2003

Wyndham Hotel
1400 M Street, NW
Washington, D.C. 20005

 

COUNCIL MEMBERS PRESENT

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

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

Francis Fukuyama, Ph.D.
Johns Hopkins University

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

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

Alfonso Gómez-Lobo, Dr. phil.
Georgetown University

William B. Hurlbut, M.D.
Stanford University

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

Paul McHugh, M.D.
Johns Hopkins University School of Medicine

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

 

INDEX

SESSION 5: BIOTECHNOLOGY AND PUBLIC POLICY: DISCUSSION DOCUMENT ON THE U.S. REGULATORY LANDSCAPE: PART I (ART, PREIMPLANTATION GENETIC DIAGNOSIS)

CHAIRMAN KASS:  All right.  Good morning.  This is the fifth session of this meeting, and the first of two sessions this morning devoted to a discussion document on U.S. Public Policy on the Biotechnologies that Touch the Beginnings of Human Life:  A Detailed Overview, a document prepared by the staff under the direction of Carter Snead, our General Counsel.

And first of all, I want to express on behalf of the Council our gratitude to Carter and members of the staff for preparing such a comprehensive and thorough document for our discussion.

I have invited Carter to join us at the table to deal with any particular questions that might come up that he could perhaps help with though.  As I will indicate in a few minutes, this is not the occasion for line editing or quarreling about this or that particular fact.

But it would be a lot easier than shouting across the room if we want to address a question to him.  So, welcome indeed.  At the risk of repeating a few things that I said yesterday, because I would like to make sure that they are part of the record of this discussion, and where we are not simply inviting comments from our guests, but speaking about our own work as generated internally, I think it would be useful to remind ourselves of how we got to this point, and what this document is and is not.

And then to set something of the goals for our discussion of it today before we proceed.  The interest in regulation of biotechnologies is a topic that goes back to our first meeting, when Frank observed that councils come and go, and have their discussions.

But amid all of this activity, it is very far from clear whose business it is to actually monitor, oversee, and offer guidance where guidance might be needed in order to safeguard and to advance the area of human goods that are at stake here. 

And we really aren't clear which institutions, public or private, are now responsible for what sort of oversight a regulatory activity under the name of what.  I mean, some of the institutions are clear, but it has been on our mind from the beginning.

Then as a result of the cloning report, where we were tackling a teeny, tiny piece of the larger area of the conjunction of reproductive technologies and the coming of possible interventions based upon genomic knowledge, there was a recommendation that one actually take up the subject of the regulation of biotechnologies in this particular area, technologies that touched the beginnings of human life.

And that the Council in fact authorized the staff to prepare a discussion document surveying the status quo without prejudice as to what would result for the Council as a result of activity, that activity.

And this document is the fruit of that effort, and its principal aim, and I am reading now from the document, "is to provide council members with a detailed account of the institutions and authorities that presently govern the uses and applications of the biotechnologies and practices at the intersection of assisted reproduction, genetics, and human embryo research."

"It explores precisely who currently provides oversight and guidance in this context pursuant to what authority, according to what principles and values, and to what ultimate practical effect.  Strictly diagnostic and expository in nature, it is intentionally neutral regarding what changes, if any, might be necessary, desirable, or feasible, if one should wish to improve upon the present arrangements."

And the document goes on to indicate that it is that we have chosen this focus.  It is not assisted reproduction, per se, nor the human embryo, or the evolving understanding of human genetics. 

But rather the unique interactions at the conjunction of these activities, and the new possibilities that they create for controlling and perhaps some day remaking something of the character of human procreation and human life.

And I think that the document also makes a very important point if it had not been noticed before, and that is that although assisted reproductive technologies are now firmly established within medical practice, they are unusual in medical practice because it is the only instance in medical practice where the treatment of a condition or a disease, depending on how you would like to look at it, requires the coming into being of a new human being in order to alleviate that condition.

And that therefore there is ample reason for extra tension and extra scrutiny where new human beings are produced, and to begin with, the document is informed by a deep concern for the safety and the well-being of children  born with the aid of these technologies, and therefore the question of whether we are doing all that we can do in order to safeguard their well-being.

The next thing that I would just call your attention to, and I won't read it through carefully, but on pages 7 through 9 the document emphasizes that all regulatory institutions and practices operate either explicitly or tacitly in order to promote or protect one or more important human goods. 

And the document, I think without developing these goods, at least lists them, and I call everyone's attention to the lists there on page 8, and then in the name of those goods the various kinds of ethical concerns they might give rise to on page 9, and these are things that have been on the minds of staff when they have been looking at the various institutions that are now active in this area.

And the strategy of the document as you all know is to take five different aspects in this area; assisted reproduction, per se; and the power to screen the possible powers to engage in genetic alteration of embryonic life, embryo research, and commerce, and in each case looks at the activities.

Let me suggest what I think would be reasonable goals for this morning.  I think that it would be very good to see whether the council agrees with the identification of the various human goods that are here identified, and if anything to indicate which of these are most deserving of our attention.

This is an ethics council after all in the first instance, and not a regulatory body, and what we would have to contribute to this discussion in the first instance is a certain clarification of the human good, and principles, and ethical norms that we care about.

Second, to see whether the staff or the council shares the view of the document regarding its assessment of how well those particular goods are being promoted and protected, and then third, as we move toward the end of the morning, some suggestions for further staff work on how we can advance our own efforts in this area.

I think that is an outline, and let me just offer a couple of caveats for the discussion.  First of all, the conversation this morning could proceed at various different levels.  I mean, we could descend to the picayune or the dissection of little remarks in the text, or someone might decide that now is the time to offer grand suggestions for new regulatory projects.

I think both of those things will be, I think, appropriate for where we are now.  If people have specific criticisms or comments on the documents, by all means let's have them.

And by the way, members of the public, especially our presenters from yesterday, are invited to submit comments on this document as well.  Second, there was a very useful distinction offered in the discussion yesterday — well, two useful distinctions — that I think are worth keeping in mind. 

One is the distinction between efforts — between the adequacy of the regulatory activities, touching the practices that are now in existence, versus thoughts about how we can anticipate decision making for things that are just around the corner.  That was a distinction made by Bill Kristol, I think, at one point in the discussion. 

And what one thinks about what might be needed to improve the practice of assisted reproductive technologies is not necessarily the same thing as what one might think about whether — about how one would go about deciding whether PGD should become a universal practice, or what one should think about the possibilities of germline modification, when and if that became feasible.

So thinking about what we have here now as a practice, and thinking about things that are pretty visible, and what kinds of discussions are necessary for those.

Lastly, a delicate matter about the question of the human embryo in our discussion, and I at least wanted to — and so that this discussion doesn't just simply appear as the elephant in the room that no one recognizes, nor does it appear as a herd of elephants in the room that makes anything else impossible.

Any discussion of public policy pertaining to biotechnologies touching the beginnings of human life will necessarily open the question of the moral status of the developing embryo, and it would be futile and probably wrong to pretend otherwise. 

Yet, I would suggest that it would be a shame if a debate about what we do or don't owe to the embryo, distorts, obscures, or prevents an inquiry into a range of other important questions.

As a council, we are divided on the embryo question, as is the country as a whole, and nevertheless I think that we are agreed that respect for the intrinsic worth and dignity of children who would be born on the basis with the aid of these technologies is an important consideration, especially in an age where genomic knowledge will be wedded to these new technologies, and where there are opportunities to use these just not to promote health, but to practice enhancement, sex selection and the like.

The human goods at stake do include the good of the human embryo, but the reality of the other human goods in play demand that we avoid becoming bogged down in this debate.

And I think the way the staff document has proceeded about the explicit question about the state of the embryo, while it comes up early, has a section all to itself, primarily in the area of embryo research, whereas the earlier questions are on assisted reproduction, genetic screening, the possibility of genetic manipulation.

And it is that nexus of things that I think deserve our attention.  The last point on this, and then I think we should begin.  I would like as we think through today and beyond today, some people have perhaps global ideas for what would be reasonable to do.  I suspect that on those global ideas that we might come to blows.  But it would be I think a useful strategy to try to think about those areas in which all reasonable people might agree that there is some kind of suggestions for improvement that could be offered, even if they turn out to be modest, as well as thinking through the possible longer term strategies for something larger.

So I have more to say about that, I think, after we see how the discussion goes.  But the floor is open for your comments on whether the document has at least, to begin with, identified the things that we are to care about, and whether it has illuminated us, and given us illumination on how we are doing with respect to those matters.  Alfonso, please.

DR. GÓMEZ-LOBO:  Proceeding more or less in the order that you are suggesting, I am turning to pages 8 and 9, which are the — I would say the philosophically most relevant ones, and I have a little suggesting, which is really a big suggestion, and it is that, in the list of human goods, that the first one we have is the health and well-being of human subjects.

It seems to me that in fairness that we should add at the beginning the life, because before you have health and well-being, you have to have life.  Human life is after all the grounding good, and it is what sustains health, which sustains well-being.

And of course it should be a major concern in any discussion of nascent and human life, and accordingly, two lines after that, I would suggest that we refer to the children not who may be born, but who may be generated or conceived.

In other words, I think that there is a good and a value there even before birth.  So I am just suggesting that we pay attention to this grounding of human good.

CHAIRMAN KASS:  By the way, I think that I would like to hear from everybody on this, just to have the reactions of everyone at some point in this discussion with respect to the document.  So if I don't hear from you, I will call on you.  Alfonso, do you want to continue?

DR. GÓMEZ-LOBO:  Well, I don't know what to gather from the silence.  I hope it is approval.  I want to mention something on page 9 concerning the ethical concerns, and this is of a different nature.

I am a little bit worried about the claim that there are hazards of living with too much genetic knowledge.  I really don't quite understand that.  I am personally of the conviction that there is never too much knowledge. 

That knowledge and truth is a human good, and the more we know about our genetic constitution the more we know about the development of life, and the more we know about anything is good.

I just cannot see what it would be like to be living with too much genetic knowledge.  I would love to know more about my own genetic constitution, and to know if I am doomed to die in the next 3 years or whatever.

So I would be very careful about the praise of ignorance, which would be implied in the notion that we know too much. 

CHAIRMAN KASS:  Gil, do you want to straighten him out?

DR. ROWLEY:  I might just say parenthetically that I have underlined that particular phrase and wondered about it myself.

CHAIRMAN KASS:  Gilbert.

PROF. MEILAENDER:  You may be right, Alfonso.  On the other hand, there are large arguments about whether one would want to know that one had a late onset disease like Huntington's, for instance.  I mean, some people seem to think that they would want to know, and other people are pretty confident that they would rather live without knowing that.

And I am not certain that general principle about the good of knowledge helps us conclude that one set of those people is making sort of prudentially and practically the right decision, and another set of people is making the wrong one. 

It seems to me that it might be hard to say that there was only one sort of decision that all human beings should make in such circumstances.

CHAIRMAN KASS:  It is not that we are necessarily endorsing these, but these questions have been raised and the genetic counselors often agree not to present information for those kinds of conditions where there is at the moment no remedy, and that there are also pregnant woman who do not want to know or question the genetic results of amniocentesis, and they choose not to, although one could say that there is a certain amount of pressure placed upon them in fact to have this done.

So it is not like anybody is here arguing as a general principle in praise of ignorance.  The question is that Hans Jonas has in fact a very nice paper where he talks about this as a kind of scientifically-based astrology, which the foreknowledge of the future was somehow frowned upon.

And at least it is a question, that's all.

DR. GÓMEZ-LOBO:  Yes, and I am of course aware even in myself that often times one does not want to know.  It is typical of the spouse who does not want to know whether their spouse is cheating on him or her or not, and things like that.

But if we are — as an Ethics Council enumerating ethical concerns, I think we should lean in the other direction.  In other words, the fact that, say, a couple may not want to know the sex of their child should not encourage the view that if that knowledge can be pursued, then a council like this one should encourage that.

I think that there is a much broader — should I say — value in encouraging knowledge, and leaving it to the individual if the individual doesn't want to know.

PROF. MEILAENDER:  Could I just ask him a question?  I just wasn't sure what is suitable.  I understand you to say, and I don't want us to descend forever into the nitty-gritty of this, but that if a couple can know the sex of their child before that child is born, you think that is knowledge that they should definitely pursue; is that what you said?

DR. GÓMEZ-LOBO:  No, what I was suggesting is that if as say scientists if that knowledge can be obtained, they should be obtained whether in particular cases certain couples may not want to avail themselves of that knowledge.

CHAIRMAN KASS:  Other comments?  Mary Ann.

PROF. GLENDON:  Are you ready to move to another subject concerning the material on pages 8 and 9?

CHAIRMAN KASS:  Yes.  Bill, I think you wanted to say something?

DR. MAY:  I just wanted to offer a comment.  It seems to me that there are those moral problems that cluster around the terms and conditions under which you acquire knowledge, and then those moral issues that cluster around the application of knowledge.

And this simply suggests, and it doesn't argue, to eliminate knowledge, but simply acknowledges the fact that there are a cluster of problems that accrue for human beings in living with knowledge, and that is all that is being affirmed it seemed to me, and not an argument for know nothingism. 

CHAIRMAN KASS:  Yes.  Thank you.  To this point, Jim?  Jim Wilson is still on this point.

PROF. WILSON:  I think my problem with page 9 and part of page 8 comes from the fact that it is stated in such summary form that I don't understand the meaning of many of these propositions. 

Now, obviously in a document of this sort, you have to have a kind of overview, and at the end, a summary.  So I am not objecting to the principle involved here.

But I am concerned that stating such things as the hazards of living with too much genetic knowledge, or the effects of commercialization on the dignity of human procreation, or something appears to teach the primacy of genetic causation.

These are phrases that will be differently interpreted by people, and to some they will sound like arguments, especially since in this section on ethical concerns, we have very few concerns that reflect the view that some people may have that assisted reproduction ought to be encouraged, and that more money should be spent on it.  That the Federal Government should embrace it.

This is not necessarily my view, but there are people, and we heard some yesterday, who clearly say that they don't want regulation.  They want more money.  All of these ethical concerns by and large reflected the desire to appear to control, limit, or possibly extinguish it. 

I am not saying that this is the way the staff wrote it.  I am simply saying that by putting these things so briefly without any explanation up front, it is going to give rise to concerns, and perhaps there is a way to expand page 9 by adding the equivalent of one more page, in which you state ethical concerns that argue both for enhancing and funding assisted reproduction, and ethical concerns that argue for restricting, modifying, or possibly eliminating it.

And then in a sentence or two define loosely each proposition so that we are not left with what appeared at first glance to be slogans. 

PROF. MEILAENDER:  Just a reading of the goods on page 8.  I would say that 1, 2, 3, part of 5 —

PROF. WILSON:  I was talking about page 9.

PROF. MEILAENDER:  Well, there is a summary list of the goods involved on page 8, and many of them involve reasons why one might wish to pursue these technologies.

CHAIRMAN KASS:  But let me come to Jim's aid.  It does seem to me that the ethical concerns could also include that limitation of the pursuit of the positive goods here as a result of undue restriction, or inadequate funding, or the interference with the scientific research. 

These are also scientific concerns, and I think that page could be augmented to page 9.

PROF. WILSON:  I was referring to page 9, and not page 8.  It seemed to me that those two issues are somewhat different, and it was page 9 that concerned me. 

CHAIRMAN KASS:  That is easily taken care of, and should be taken care of.  Michael Sandel, are you still on this issue?

PROF. SANDEL:  Yes.

CHAIRMAN KASS:  Okay.

PROF. SANDEL:  Well, this follows Jim's observation, which I agree with, though I think there are two ways of dealing with it, and I think it reflects an ambivalence that runs through the document.

On the one hand, the document wants to be neutral and your introductory remarks suggested reasons for it being neutral on what regulations should be enacted.  And so that part of the project makes it sensible for Jim to raise his question when he points out that this isn't really a neutral list of ethical concerns if we want to be neutral.

So one way to try to fix it would be to try to have more balance, more enthusiasm for these technologies to balance the worries about these technologies.

But another way to address that problem would be to decide that perhaps we do want to — if not to propose a grand regulatory structure, and that is not the purpose here, but to have a document with a certain bent, with a certain point, and I think the document as written does have a certain bent, a certain point, because the gist of the diagnosis and assessment in almost all of these areas is to suggest that there is no adequate regulation for many of the ethical concerns.

So I am not complaining about the bent.  I share the concerns that the bent of the document gestures toward, but I think it may be — I think that there is a confusion here about what our purpose is.  Do we really want simply to lay out neutrally the various ethical considerations and neutrally assess, or do we want to, short of providing a proposal for regulation, point in a certain direction?

And I think we are going to be wrestling restlessly today with this page by page, issue by issue, unless we decide that we want to point in a certain direction, short of specifying the regulations.

Or whether we really do want a neutral document that people on all sides of all of these issues could equally agree with. 

CHAIRMAN KASS:  Let me help on that, or try to help on that.  The sentence that has the word neutral in it is on page 6, and this document is intentionally neutral regarding what changes, if any, might be necessary, desirable, or feasible, if one should wish to improve upon the present arrangements.

I mean, one might decide that the present arrangements are not doing a particularly good job defending value X, and yet conclude afterwards that the cure might be worse than the disease, or that there isn't anything feasible that can be done other than exhort. 

So the neutrality of the document is with respect to further suggestions for improvement.  The document ought not to be finally neutral.  I mean, a diagnosis after all is first of all a careful description, and then finally some kind of an assessment of how well the current arrangement is doing in promoting certain goods and protecting others. 

And I don't think it means to be simply neutral in that sense, and is that — there is no prior commitment as to suggesting any particular alteration in this.  The first task before you would even think about doing that is to try and figure out whether the current system is doing all that it should.

And you may decide that there is nothing better to be done, but I think that this is a description moving in the direction of a value, of an assessment, but to do that you have to be fairly clear as to what goods are — what the goods are that you really care about, and what are the ethical concerns.

If the list of ethical concerns is incomplete, we should enlarge them.  Michael, please.

PROF. SANDEL:  An example of the kind of thing that I mean and that runs through the whole document, which I sympathize with, and so this is not a complaint.

CHAIRMAN KASS:  I understand.

PROF. SANDEL:  It is a question about what our project is here.  Take, for example, the conclusions to each of the sections.  As I read them, most of the conclusions point to a problem, or an inefficiency in the current provision. 

Take, for example, on page 71.  And I am jumping ahead, but this is a general point that even begins in the page that Jim was identifying, the conclusion on PGD, "While currently a small practice, PGD is a momentous development." 

And then the last sentence, the conclusion, "There are no government or non government guidelines regarding the boundary between using PGD for producing a disease-free child and using it for so-called enhancement purposes, or to produce siblings for children."

Well, this points in a certain direction.  Here is a momentous development, and it is of ethical concern, and we conclude that we don't have adequate regulatory guidelines for dealing with this momentous development.

Now, I don't dispute — I am not disputing that, but —

CHAIRMAN KASS:  The word "adequate" isn't there.  It is just reports, and there are no guidelines.

PROF. SANDEL:  Well, all right.  But that is the gist.  The gist of each conclusion is of that character, and I repeat that I am not quarreling with the gist of each conclusion, but these are conclusionary.  These do point in a certain direction.

And I don't — we could either decide that we should try to tinker with the language so that there is no pointing in a certain direction, which would be one way of really trying to balance this, or we could say that we want to affirm pointing in a certain direction.

But I think unless we decide what we want this project to be, then we are going to have — and whether it is on page 9 or on any other — every conclusion really to every section, we are going to have the same kind of ambivalence.

CHAIRMAN KASS:  Does someone besides me want to  speak to Michael's point, because it is an important point.  Rebecca.

PROF. DRESSER:  I agree with both Michael and Jim, in that I do think we need to make a decision about whether we want this to take a certain perspective, and I don't have a problem with taking a perspective, but I think we need to be very precise and direct about it so that clarifying language — to make sure others understand what we mean by dignity and unwanted genetic knowledge, and cohesion in genetic testing.

Just to be very careful about what we are trying to say and also I don't think that taking a perspective is inconsistent with trying to be balanced and fair in saying, yes, there are tradeoff's, and so there are these goods.

And more regulation would cost more money and so the costs to infertile couples would go up, and so forth, and so I just think that we should be out there and clear, rather than — sometimes there is some indirect language that really seems to be trying to get a point across without really saying it.

PROF. SANDEL:  Could I just add one other sentence, and this is at the end of Section One, page 58 to 59.  The last sentence says, "For most ethical matters of concern to this Council, beginning with the well-being of children, well-developed practices of monitoring, data collection, or investigation, are virtually nonexistent."

Well, you could say that is just reporting neutrally a fact, or you could say it is pointing out a cause for concern.  And again it is a concern that I would endorse, but I agree with Rebecca. 

CHAIRMAN KASS:  Well, do other people want in on this?  Mary Ann.

PROF. GLENDON:  Can I be in on this and then raise the ethical concerns?

CHAIRMAN KASS:  Indeed.

PROF. GLENDON:  It seems to me, Leon, that your Item Number 3 that you wanted to discuss this morning may have to be Item Number 1, and on that I would say in terms of further staff reporting is a report on the status quo, and a very preliminary report, and an excellent one I might say.  I found it very helpful.

But my ideal or model would be something — for further work, would be something like what we did with cloning, and the very first day that this council met, you said that our chief aim was to raise the level of the national conversation of these very difficult issues.

And I think that we are now moving toward raising the level of the national conversation about the difficult bioethical issues, and another set of difficult issues, regulation. 

Regulation is not even well understood and well taught in law schools.  So that lawyers, like most other people when they think of regulation, they think of criminal law, and what needs to be explored here is the whole tool box, the enormous tool box of regulatory techniques.

There is enough learning on this subject scattered around, and we know a lot of what seem to be good regulatory ideas that turn out to have unanticipated side effects and that is caused in the legal world a lot of people who were, say, enthusiasts for regulation in the new deal mode, have started to become aware of those unintended, unforeseen, consequences, and to be a little bit more cautious, and to want to rely more on empirical work.

So I won't go on and on about that, but just to say that I think — I mean, my suggestion for where further work should go would be toward a report aimed at raising the level of public understanding of these very difficult issues.

I think that is something that we did well on cloning and we could do it again in this area.  Now could I raise my ethical concern?

CHAIRMAN KASS:  Yes.  Other people can speak after and still continue with the other conversation, but please, continue.

PROF. GLENDON:  I would just like us to consider adding to this series of ethical concerns something like this.  The general topic of this paper is public policy and biotechnologies.

Public policy not only includes regulation, and it includes certain decisions democratically arrived at about priorities.  And in a world of scarce resources, if we were talking about the space program, there are always questions about how much of our national resources do we want to put into very expensive technologies. 

We are all in favor of curing diseases, and we are all in favor of knowledge where knowledge is safe, but we don't have unlimited resources.  So somewhere under a broad understanding of what ethics in this area, there has to be some consideration of (a) what the priorities are, implicit or explicit; and (b) how those priorities are arrived at. 

These subjects that we are discussing have enormous implications, whether you are talking about public funding, allocation of public funding, or whether you are talking about insurance, and who is going to bear — if something is going to be classified as a disease, and it involves very expensive technologies, where is the public discussion about whether we want that particular thing to be a priority.

And to make it quite concrete, and to think about the problem worldwide, very little is being done worldwide on primary health care, and things like clean water, fighting infections that take lives of children.

And we are having a discussion mainly here about conditions or diseases that affect an affluent society, where people are worried about things like the diseases of old age, and then fertility.  I just think that sort of thing should be on the table under the heading of ethical concerns.

CHAIRMAN KASS:  Thank you.  Jim Wilson and then Bill.

PROF. WILSON:  I want to respond once again to what Michael said, and it echoes a bit what Mary Ann said.  I think if Michael and I went through this document together that we would find many passages where we would say this complete absence of guidelines and regulations is deeply troubling and we should do something about it.

That is the way much of the New Deal regulation was created in the 1930s about the stock market.  We must do something about radio broadcasting.  We must do something about civil aviation.

And what they did in many, though not all of these cases, was in my view counterproductive.  What I would most like to see come out of our staff work in our next iteration is a call for learning more about the important aspects of this problem.

We have now what, a million children born with assisted reproduction worldwide; and a 170,000 or 200,000 of them are in the United States, and we don't know much about these people. 

And before we get concerned about the edge of scientific development, pre-plantation genetic concerns, and creating designer babies, and raising children to be organ donors, which I think is impossibly unlikely.

We ought to find out where the main action is today on the main problem, and do so in a way that gives us a sense of the magnitude of the difficulties, and who is suffering, so that we can put it in context.

We may say a little bit of regulation is needed to control this, or we may say that these are acceptable risks, or we may say that the incentive  now is being supplied to clinics that encourage artificial reproduction, assisted reproduction, are the wrong incentives and the incentives should be changed. 

I don't know what should be done, but I don't want to see this document have a bent as Michael does towards regulation, because I don't think we know enough about the subject to design a good regulation.

I think we can do the most good this council can do is say to the government and other agencies, look, something has been created here, and where we don't know the outcomes well enough to tell you whether we are doing a good job, a bad job, or an intermediate job.

And until we can answer that question, we really can't help you, and no one else ought to be able to help you to design a regulatory system. 

CHAIRMAN KASS:  Bill Hurlbut.  Was this directly to Jim, Bill?

DR. HURLBUT:  Well, kind of.  Let me just make a brief comment.  I mean, I agree certainly with that, but one of the problems that may need some kind of intervention or regulation is that there have not been follow-up studies because there is no federal funding.

And private clinics are not necessarily going to do this, and also there aren't studies that look at the new technologies as they unfold in a systematic way — either ethically or fully scientifically.

I mean, there are new technologies always emerging, and I don't mean to over-exaggerate this, but to some extent this is an experimental edge of medicine.  They are constantly changing the medium, for example, in which the embryos are cultured, and that amounts to maybe not a dangerous experiment, but at least in an experiment of sorts.

Nobody regulates that, but the larger thing is that notwithstanding the truth of what you said, I think what is interesting and important here goes beyond that. 

We are on the edge of moving this technology from what looked first like a therapy, and overcoming a barrier, to now extending into a realm that seems something beyond the traditional role of medicine.

Yesterday, one of the speakers responded very strongly in a moment where she said this is health care, and in one of the documents there was a reference to the motivation for ART as being a natural, noble desire.

But it seems to me that there needs then also be some reference to natural means, and there was the problem.  We are moving this technology beyond what we might call the natural and into an extension somehow of its significance.

If the first paradigm for assisted reproductive technologies was a physical blockage of the fallopian tubes, and that was then bypassed by this procedure, it soon became a physiological blockage, and then a psychological blockage, and now it is to the point where at least theoretically you could go as far as to say there is a gender blockage, because I mean, this is very far out maybe, but nonetheless in the last month it was announced that it is possible perhaps to generate gametes from ES cells, in which case one could argue that a completely infertile person does not produce gametes could produce gametes of both sexes.

And you would get a wholly unnatural — it has been called the post-reproductive era, but it just defies the categories of the natural around which human life is organized in both its biological integration and its psychological, spiritual meaning.

And that I think is worthy of our consideration in anticipation of what is happening.  We are on the launch pad of this.  It is not at this time to get the rocket directed in the right way, rather than when it is already set on a trajectory.

CHAIRMAN KASS:  Bill May.

DR. MAY:  To return to page 6, the word diagnostic does have a evaluative element in it, and therefore the claim of neutrality is a little misleading here.  It is strictly diagnostic and expository in nature. 

It is intentionally neutral regarding what changes if any might be necessary, desirable, or feasible in response to this diagnosis.

CHAIRMAN KASS:  Right.  You got it right.

DR. MAY:  Pardon?

CHAIRMAN KASS:  You got it right.  That is exactly what it says.  I mean, there is one part which is not simply neutral, and one part which is neutral.

DR. MAY:  Well, in regard to Jim's point, we don't have enough knowledge, but we do know that we don't know enough, and that does move in the direction of some kind of monitoring and surveillance in the acquisition of this information.

And I mean in a stronger sense would be — and I think that is further than I think most would want to go, is to say that it is intentionally neutral regarding what changes if any might be necessary, desirable, or feasible.

In response to the inadequacies in oversight, and regulation identified in this document, now that would acknowledge that the diagnosis moves in a certain direction, but remains still neutral as to what should be done in order to avoid Jim's characterization of the tendency in the '30s to automatically assume what everyone did might be better than what one had.

CHAIRMAN KASS:  Frank.

PROF. FUKUYAMA:  Well, I just want to second Bill's point.  I don't think that we should dismiss these technologies that are around the corner, but still in the future, as simply science fiction and beyond the scope of what we are doing.

I mean, Bill Kristol made this point and I think you yourself, Leon, yesterday made this point; that if all we were interested in was the current safety and adequacy of the regulation of IVF as it is currently practiced, we would not be holding this session. 

It is not that interesting — I mean, it is an important issue, and it would fall under the scope of this council.  But in itself, I don't think that is a compelling enough issue to devote significant time to this. 

There is a 800-pound guerilla lurking out there, you know, which is driving a lot of this, which is the ability to increasingly consciously shape the characteristics of children, and to do it for — in some cases potentially non-therapeutic purposes, and I think that is the single issue for me that we ought to keep a focus on, and therefore — well, that's — and so I think that a lot of the ethical issues, rather than a long list of a lot of little things, I think that in a way that single issue really summarizes for me what are the important issues that we need to confront.

CHAIRMAN KASS:  Let me respond briefly.  It seems to me that Jim's point is well taken, and that there is at least in some areas here what one should simply call for is further information to make sure that we understand the dimensions of some kind of difficulty.

But one of the interesting things that comes as a result of scrutinizing the way assisted reproduction technologies have developed and are in fact monitored in this country, it is very instructive to see what difficulties we might face if things which are not just futuristic, but things which are here are handled in the same kind of way.

And I am as you know rather skeptical about germline modification, and designer babies.  I don't think that is the question here, but great increases in pre-implementation genetic diagnosis, in the light of coming genomic knowledge, and there are some people who claim that it is going to be very, very — acquire a great deal of prominence.

And what we have seen just in the last few years are a couple of things which move from sort of experiment into routine clinical practice, where the only thing we now have operating are the guidelines, the self-imposed guidelines developed by the profession, which as we heard yesterday are simply hortatory and not enforced.

And I am thinking of a couple of things in particular.  There are less than 2,000 babies born after PGD in the world, and that is roughly the figure, but no one has set up a longitudinal prospective study of what happens to those children.

And at the moment no one cares to do so because no one has an incentive to do so.  Similarly, ICSI, there are all kinds of antedotal reports on the risks of using this procedure.

And yet it is now in some clinics being used a hundred percent of the time, partly Jim, I think, in response to the perverse incentive that is provided by now having to post your success rate so that people can see which clinic has the best success rate, and you get a higher success rate with ICSI.

And there are some clinics in which every single assisted reproduction is produced in that way, and there isn't a study on — a formal study, and a prospective study, to see what the implications are for the children that are born.

It is not to criticize that, but it is to see that all kinds of new things that are coming — and the sex control thing also — is that a decision that should be simply left without public debate to the private choices of the people in the fertility clinics, and their providers.

Or is that something that the larger public should have a say in.  So partly I agree with Jim that there are things for which we don't know enough, and what we really have to do is get more knowledge.

But there are other areas in which we see how the pattern of decision making goes.  It is not a matter of public decision.  It gets brought into medical practice, and once it is in medical practice, you simply have to rely on professional codes and professional pressures.

And not only I, but Dan Foster yesterday in his questioning indicated that there were certain kinds of difficulties as to whether the professional self-scrutiny in this area has been adequate, especially if as when Rebecca raises the question do you regard the unborn child as a patient of yours, and we got no answer.

And the answer is that they don't, because as soon as a pregnancy is established, the patient goes to the obstetrician, and the pediatrician and the parents look after it there.

So there are ways in which — and I am not second-guessing them, and I don't mean to second-guess the way that this has developed, but we have seen something about how things have gone, and then the question is whether we should simply silently accept the things that are coming on the same model, or whether there really are things going beyond simply the treatment or alleviation of infertility at stake here, whether some kind of at least data gathering, monitoring, oversight, anticipatory, is warranted by what we see.

Not 50 years from now, but this year, next year, 5 years from now.  So I would like to underscore that.  Janet, please.

DR. ROWLEY:  Let me just make a few comments.  I am pleased that you said designer babies seem to be highly unlikely because this is opposite to what Frank says, with the 800 pound guerilla right around the corner.

PROF. FUKUYAMA:  I was not referring to germline.  I was referring to exactly that same set of issues, and what I said is not predicated on my belief that germline is around the corner.  I do not believe that.

DR. ROWLEY:  But this germline designer babies is certainly mentioned a number of times in this document, and I think that certainly — who knows, 20, 30, 40 years from now, we may have enough genetic knowledge to do that, and I think we are equipped to deal with now.

So I think that should not be an issue.  You made the statement, Leon, that there is no incentive for clinics to follow up on babies, and what both the — what several of the people yesterday, including Kathy Hudson, pointed out is that such follow-up studies are extremely expensive to track down and find the parents, and find the child, and do some kind of evaluation of the status of the child, costs a great deal of money.

So where is that money going to come from?  The clinics do not have that money, and the government so far has not provided such funds.  Kathy was saying that her foundation was going to be doing some of this with the CDC, which has just recently had responsibility in this area. 

So a positive thing from this committee or council could certainly be the emphasis to move ahead, and more data are required, and to gather that data costs money.

And that we would urge that whomever comes forward with the money to carry out these studies so that we could proceed on the basis of some knowledge.  Along those same lines, it has also been pointed out that all of the developments in assisted reproductive technology are really derived from experiments in the individual clinics, all of which are carried out on patients and potential children.

And there is no funding for research as to what the effects of such immediate changes or other developments are on the health of the potential child, as well as other things.

So that it is absolutely true, and almost unique in medicine, that all of your experiments are carried out on living subjects, with the outcome somewhat uncertain.

And finally I just want to comment that I think Bill is referring to the paper in "Science" of Kay Hubner, of developing oocytes from embryonic stem cells.  Maybe you were referring to something different.

But this was in a murine embryonic stem cell line, and of course we know that trying to extrapolate from animal situations to humans is fraught with a lot of danger. 

CHAIRMAN KASS:  You are not going to argue about that particular point?

DR. HURLBUT:  No, it is just that — well, I mean, I agree, but one of the problems that strikes me with ART is that so much of this technology seems to have bypassed thorough animal model studies first.

I mean, I have very mixed feelings about this.  Yesterday when we were hearing testimony, I thought that some of it was pretty compelling about this — about infertility being at least a disorder, a disease.

I feel like we are in a bind here.  On the one hand, we don't want to endorse this on a Federal level because it has got so many controversial edges.  On the other hand, we are neglecting an important realm of social need.

And I think that maybe one of our recommendations ought to be some limited Federal assistance in studying all of this that goes beyond what has been done up to this point.

But one of the things that should include are good animal studies to the degree that they can simulate the human, we should at least do something to see for example whether ISCI has generational effects before we start bypassing the sperm competition that is involved in fertilization, and whether the disruptive effects of penetrating the plasma membrane and so forth have an effect.

I mean, ICSI went from a serendipitous discovery.  The reason that it wasn't known is because you can't do ICSI with mice.  And you are right on that level, but now they have figured out ways to do it with mice, and we can do it with some other creatures.

But it went from a serendipitous discovery to clinical use in 18 months, and with virtually no in-depth studies.  And I think that strikes me as wrong.  That just strikes me as medically imprudent, if nothing else. 

And we should supply a context in our civilization where such a large need is somehow legitimately studied, at least to the borders of the ethical issues.  And we should try to use whatever animal models can simulate the human. 

CHAIRMAN KASS:  Could I — I am going to call Paul and Alfonso in just moment, but could I suggest that — I am going to try to get us back to things having to do with the document as a whole rather than some of the particularities. 

This is not to say that the points just made are not important and they will be duly noted in what we do further.  And Paul and Alfonso please feel free to go where you would like.  In fact, why don't I let you go first and then I will start my questions.

DR. GÓMEZ-LOBO:  My suggestions along these lines — may I, Paul?  No, I just — at least in my mind, I am becoming a little bit clearer about what we are doing here.  It seems to me that we should treat the document, in fact, as a descriptive paper of what is out there.

And it should be criticized on that basis.  Let's say if there is a claim that that is no regulation of an activity, and someone knows that there is, then that would be a matter of correction.

Now, descriptive statements are always borderline with the valid ones, but I would defend the document and say that by and large it does satisfy the requirement of being neutral.

Now, to say that there is no governmental or non-governmental guidelines regarding something does not imply evaluation.  Someone might say that's great, and let's leave it like that, and someone might say, no, we should do something about it.

But that generates a second task, or a second document, a second report, and it seems to me that we should clearly separate the two tasks.  We should once we have a feeling that this indeed reports correctly regulations and ethical concerns, then we should so to speak close the book and move on to address those issues that Frank has mentioned, and everybody else has mentioned. 

CHAIRMAN KASS:  Thank you.  Paul, please.

DR. MCHUGH:  Yes.  I also am very pleased with this as a first draft approach, as it encounters as we have seen here a commentary that could shape its effect, and its ultimate expression.

But I want to come back to our beginnings, and say that I am concerned about the document a little bit in the sense that it raises many appropriate ethical concerns, but often not of the context of the real feeling for the issues that have generated the problem.

It is as though here we recognize that reprogenetics has done good for certain kinds of conditions, and it is appropriate for them; and then it jumps quite quickly from that to, well, here is what we are concerned about.

Not that I don't share those concerns, but I also want to emphasize the sympathy that we should have for these conditions.  Now, there is only one reference to a condition that I know very well, and that is Tay-Sachs disease. 

Now, let me just tell you that Tay-Sachs disease is an awful condition for a family to face.  It is a condition in which a child is born, and ultimately very soon becomes extremely dilapidated and dies. 

For a family to consider without help a subsequent pregnancy, let me just tell you that it is more than I can ask of them.  That's all.  I mean, you ought to just sit back and say, listen, I can't ask them to go through that without some help.

And I am doing that as a doctor who has carried a family through.  Now, if there was some further expression, as I think this board does appreciate, that this kind of suffering will be potentially through the advances in reprogenetics that families could be spared that.

Then we would know a little bit more what the stakeholders have, and let's get their dukes up with us at the beginning, and that's what I want.  I want this — and by the way, I agree with everything that has been said, especially what Mary Ann said about how important it is for us to speak to the American public, and have them see that we are honest brokers in this.

But without something more, even something like a case study or something that shows the suffering that prior to this advance would be more than any of us would want to offer to a family, we will lose out.

CHAIRMAN KASS:  Excellent.

DR. ROWLEY:  Well, following that up, it is my impression that the incidents of Tay-Sachs in Askernazai Jewish families has dropped remarkably with the help of various types of genetic diagnosis.

And those are figures that are available and could be included.  So I did actually have in my notes the comment that this is written in a sense from a very negative point of view of only concerns and nowhere do we talk about what for individual families how remarkable this has been.

In other families up until recently for X-link disorders, such as muscular dystrophy, you automatically aborted every male because this, by and large, affects mainly males. 

So in families where this was segregating, they aborted 50 percent of the males, and they aborted 50 percent that may have been normal, but the family couldn't face the prospect of having another affected son.

So none of the positive things are portrayed in this document, and I guess as long as I have the floor, if you don't mind my intervening, but I would like to suggest that — and you may think that this is word snipping, but I think it is more than that.

Even if you look at the table of contents, Items 1 through 4 are power to initiate human life by artificial means, et cetera.  I think what we have and what we are describing here is the ability, the capability, the capacity, to initiate human life.

And I think that throughout the document that power is used repeatedly, and that does have implications that are not necessarily neutral, and I would certainly recommend that one consider changing that wording, because then I think it also changes the concept or the flavor if you will of the whole document.

CHAIRMAN KASS:  Gil.

PROF. MEILAENDER:  This is really just a question.  I don't have any strong feelings about it, or at least if I have them, I am not yet aware of them.  I may become aware of them.  But if one were constructing a document about regulation of the airline industry, or something, you wouldn't start with a long discussion of the benefits of being able to get in 4 hours from Chicago to Portland, or give a little vignette of someone who had been able to get out there quickly.

It would not occur to you to do it.  Now maybe our subject matter is different, and maybe I am missing something.  I do agree that there are real questions about this language of neutrality.  I mean, that question I took seriously.

But I just — before we go too far down this road, I would at least want to think about kind of what you are doing if you construct a document on regulation.

If we want to demonstrate that we are sensitive folk, I guess that is a good thing.  But I am just puzzled.  Now, I could be persuaded.  I have no particular inclination on it, other than it just seems to me that it was sort of a puzzling way to think about a document on regulation.

CHAIRMAN KASS:  Paul, it's yours.

DR. MCHUGH:  You're not serious, Gil.  I mean, this is not an established industry that has been organized from its beginnings, and through which various regulatory processes have taken form, and we have found ourselves in and out of trouble in relationship.

This is a very new arena of human enterprise, and in which we are concerned about both what we are doing, and how we have achieved things, and what could go wrong.  And I am just saying everybody knows that, and I think you are teasing us.

CHAIRMAN KASS:  Jim Wilson and then Michael.

PROF. WILSON:  The airline industry was regulated starting in the 1930s in two ways.  First, we require a certificate of air worthiness from the Federal Aviation Administration to make sure that airplanes don't fall out of the sky.

This has provided some good, but not a decisive good, because airlines have a vested interest in making sure their airplanes don't fall out of the sky, and particularly the pilots.

But it enhanced it and it provided an overview.  But at the same time the other form of regulation vested in the Civil Aeronautics Board was to regulate prices, so that the government would set prices, and there would not be price competition.

And the effect of this was to freeze out competition, and to make certain that the prices were higher than most people could afford to pay.  I remember when I started flying on airlines, and this is back in the Harding Administration I think, you would get on an airplane and they would have a 50 percent load factor.

And you would have the undivided attention of people who were then called stewardesses.  Today the planes are packed.  Why?  Because airlines set their own prices and this was as the result of a change.  We made a mistake in the 1930s with respect to the CAB, and after a while enough people pointed this out.  So that the government decided to change it.

So that we are not talking about analyzing the costs and benefits of flying from Chicago to Portland.  We are trying to figure out what are the issues where the government can make a prudent intervention that would enhance well-being to a degree that exceeds whatever costs are associated with the intervention.

And my view is that with respect to many, though not all of these technologies, we don't yet know enough to design an intervention whose good effects would exceed its bad effects.

CHAIRMAN KASS:  Michael.

PROF. SANDEL:  I would like to go back to the general question of our purpose, and the overall point of this, though I think running through all these comments, Carter, has been an appreciation of what an excellent document this is.

And so really here we are just discussing how it should fit with the overall layman project of the council, but I think everyone agrees, and I also feel it is really a first-rate document.

Just on the airline example, if there were a public debate swirling, as there was about whether to have the Concorde or the SST, there would be much discussion about the environmental worries, and about the issue of priorities.

But there would also be some statement about the importance of getting from New York to London in 3 hours rather than 6 hours.  And that would be the closer analogy to what we are doing here. 

There is a public debate swirling about these questions.  So if we want to give a balanced account, then we should include as we would with the SST or the Concorde, the value on the one hand of getting there in 3 hours for movie stars, celebrities, and financiers, Gil, and against the social costs, and the questions of priority.

So we are — we are operating in the midst of a swirling public controversy.  We know that and that is no secret, and we don't shrink from that.  I would like first to go back to the point that Mary Ann made about how our fundamental purpose here should be to elevate the national discourse about these broad questions as we did with cloning.

Now, I don't think that Mary Ann necessarily meant that we have to replicate the format of the cloning report in the sense of proposing in this document an actual policy prescription.

But I think as I understood here, short of that, we could still lay out very explicitly the ethical concerns and the moral arguments that worry us.  And where we disagree about those, we could be explicit about those disagreements.

But I think that is a good model, and short of the specific policy, I don't see why we couldn't be as forthright about the moral questions at stake, and the way that we view them here as we were there.

Now, as for the question of neutrality, I think — and while Alfonso made the point that we should be descriptive, and he acknowledged that descriptions sometimes shades into a value of the language, which is fair enough, Bill took us one step further when he pointed to diagnosis.

Diagnosis is intermediate between description on the one hand, and prescription of policy regulations on the other.  So I think that we could consider this to be not merely descriptive, but also diagnostic, which explicitly acknowledges a normative point, or weight, or gravity.

And acknowledging it should leave room for disagreements.  I think that Janet is right when she points to the use of the term power.  That is a loaded term. 

Now, it is not one that I would necessarily disagree with, but she is right that it gives the document a certain bent to talk about powers rather than capacities or opportunities.

CHAIRMAN KASS:  Power and capacity are synonyms.

PROF. SANDEL:  Well —

CHAIRMAN KASS:  The power to do means nothing more than the capacity to do.  Look it up.

PROF. SANDEL:  Well, then in that case, then why not use the word capacity, because power has to do with — and especially when the context is regulation, and when the context is possible legislation or the State, you are arraying, or those who would want to regulate, are arraying the power of the State or of the community collectively to reign in individual powers.

Now, you could call them, or Janet might want to call them opportunities, and then we might have to sort out do we want to characterize these as opportunities, or as powers, or as capacities. 

But in any case, this is not to agree or to disagree about whether the word power should be there.  But it is really simply Janet's point is the same as Jim's initial point about the terms that are there.

And Jim was not quarreling for his part with those terms, but he was pointing out that they do have a certain bent.  So I think that we should aim at diagnosis.  We shouldn't claim that this is merely descriptive, and merely neutral.

We don't need to say that because it is diagnosis that therefore we are now in a position to prescribe specific regulations, because there are as Jim says, there is a lot more work that we would have to do to know whether on prudential grounds that such regulations would work or be desirable, all things considered.

So to come to my last point, and it is back to Jim, he and I may disagree about whether the document should have a certain bent, though I think we would agree that it shouldn't call for specific regulations.  We are not in a position to do that.

But I think we agree, and I think most of the comments around the table have supported the idea that it does have a certain bent.  Not because it is in any way dishonest or trying furtively to kind of surreptitiously to smuggle in values where they don't belong.

It is impossible to discuss in any interesting way a diagnosis of the problem without having a certain bent.  And if I could just take a look at the last — the summary and conclusion of the entire document, page 121, in the middle.

"Non-governmental oversight is aimed," and this is talking about the power to initiate life by artificial means.  "Non-governmental oversight is aimed fundamentally at ensuring the satisfaction and protecting the efficacy and privacy of the couples who seek treatment for infertility. These standards, while extensive, are hortatory in nature.  What seems to be missing from both government and non-governmental regulation, both independently are in the aggregate, are meaningful, enforceable standards for the well-being of the children who come to be born with the aid of these new powers. Moreover, there does not seem to be even oversight activity, much less effective guidelines, that aim at concerns relating to the enhanced control over procreation, and with their resulting impact on the meaning of family, children, and human dignity. "

And then on page 124, the last sentence, "As to commerce and commodification, the present system lacks a uniform approach to questions of access, and does not include safeguards or oversight mechanisms for deleterious effects on human dignity that may result from the increasing commercialization of human procreation or the buying and selling of gametes and embryos. "

Now, I agree with all of that.  I sympathize with all of that myself.  But to say that this is mere description I think doesn't do justice to the normative weight, which I would applaud, but the normative weight that this document has.

Now, to say that and to affirm that, we should discuss as a council whether — now maybe not everyone sympathizes with the sentiments embodied in that kind of call.  It is really a kind of call to action.  It is analogous to what Jim was saying they did in the New Deal, where they said here is what is missing, and here is what is not uniform, and here is what is inadequate.

There doesn't seem to be even oversight activity, much less effective guidelines, the kind of preamble to a further discussion about what actively speaking would be desirable, and those are further questions as Jim says.

So I would not quarrel with any of this.  I would support it.  But I think we should, if we want to support it, we should support it under a different description of what our purpose is, and not be embarrassed about a diagnosis that does have a certain normative bent.

CHAIRMAN KASS:  Frank, and then I would like to respond.

PROF. FUKUYAMA:  Well, I would like to return our discussion to airplanes, because I think that is actually a good way of illustrating how I think or what to think about what we are engaged in.

And this is an area that Jim knows much more about than I do, and so if I get this wrong, please correct me.  But one of the earliest Federal regulatory agencies was the Interstate Commerce Commission, which was put in place to regulate basically railroads.

And when the Interstate Highway System was created and you had an Interstate Trucking System, that function was given to the ICC, because they thought, well, it is just moving stuff over interstate borders.

I believe that most specialists that have looked back at that decision believed that it was a wrong decision because the trucking and rail industries are sufficiently different.  The economics are different and the incentives are different, and it should have been given to a separate regulatory agency. 

When airplanes were invented, they could have given it to the ICC, too, on the grounds that airplanes simply move things over interstate boundaries.

Fortunately, they didn't, and they created a separate CAB and FAA to deal with that new industry.  Now, in agricultural biotechnology, they were at this inflection point in the 1980s when the technologies were in the lab and moving out into the field.

There was in the Reagan Administration an interagency set of meetings to decide whether the current regulatory structure to look at agricultural biotechnology was sufficient.

They met and they decided that — and completely appropriate in my view — that the existing regulatory structure was adequate.  They were going to regulate on the basis not of process, but of product, and it was felt that there was not a sufficiently different set of technologies involved.

And that the current and the administrative capacity of the EPA, the Agriculture Department, and the FDA, were sufficient to handle that.  And that is the regulatory structure we have used since then, and I think that was quite right.

Where I think we are now in human biotechnology is exactly at that point that the Reagan Administration was at in the 1980s with regard to agricultural biotechnology, which is to say that we see a whole bunch of technologies moving from the laboratory into clinical practice.

We can anticipate that there is going to be a lot more of that, and we simply have to address this question: Is the existing regulatory structure sufficient to handle that set of issues?

Now, my belief is that it is different from agricultural biotechnology in the sense that the only issues raised in agricultural biotechnology were safety and efficacy. 

That is what the existing regulatory structure was designed to do, and therefore there was really no reason to consider major institutional changes.  I believe that in human biotechnology there are normative issues, however you want to define them, that are just quite clearly beyond the administrative capacity of our existing regulatory institutions.

So therefore it is perfectly reasonable for us to at this point ask ourselves whether we need to sort of rethink that question in exactly the same way that that interagency group did in the 1980s.

And I guess that I disagree with Jim, and that I just don't think that you can wait until you see those technologies move into actual practice to a greater extent, because by that time the inaction will mean that there is simply an accepted practice and it will be too late if you have affections to them, just as in the case of ISCI that it will be too late to do anything about it.

So that is how I think I conceive of what this exercise really ought to be.

CHAIRMAN KASS:  I noticed that we are at 10 o'clock, and we have a second session.  Let me hold my own remarks to you — well, did you do want to do it before the break?  Well, let me say what I think I have heard in the discussion.  I am not going to be able to do justice to everything, and the gray cells are not what they used to be, and so I don't even remember and I will have to read the transcript.

But it seems to me that — and let me start with Mary Ann's, I think, very welcome suggestion that whatever we do and put out in this area ought to be informed by the original aspiration of elevating the discussion.

And that before we start talking about nuts and bolts, or this or that, a certain kind of clarification, and here I would say on two fronts.  One is that we can't write a textbook on regulation and all of its alternatives. 

But just as in the regulatory chapter, Chapter 7 of the Cloning Report, before looking at the particular proposals, there was a brief discussion about science and society, and those kinds of questions.

And it does seem to me that something towards the beginning of this with a discussion about various thoughts on regulation, and its range, and the various things, that would be a contribution, because it looks to some people like either you ban it or nothing.

And that would be — we have something to contribute there of a semi-theoretical, or modest semi-theoretical sort up front. 

Second, it was implicit in the document, and I thought it was also explicit, and I tried to make it explicit at the beginning of this meeting, that one of the things that we could do for a discussion of regulation is actually not just list the various human goods that are at stake, but actually have the various people on the council who care about one or the other of them a lot  write a couple of pages so that those don't become simply slogans.

I mean, the human dignity is a particular vexing one, and that I have trouble doing that in a couple of pages.  But the question of the privacy of genetic information and reproductive practice, or certain kinds of aspects of human freedom, or questions about equity access, or questions about the problem of genetic discrimination, those are things which go beyond simply a concern for safety and are in addition to endorsement of the joys of overcoming infertility, and the relief of the sorrows and burdens of either being someone or caring for someone whose has these disease, et cetera.

Those human goods that are stated there as placeholders are things which could be developed in  such a document descriptively so that anybody who wants to think about regulation is actually going to have to have before them — and perhaps in some rank order.  We don't have to take all of those on.

But some of these might matter more to us than others.  But to set the table, and if you want to think about regulation, you have to think about it in the name of what you are paying attention to.

If you want to think about oversight, and never mind regulation, and you want to know what it is that you are looking at for what reason, and we make a contribution if we enlarge the scope of what ought to be within the regulatory gaze.

Next, I think that people are right in suggesting that the list of ethical concerns are on the whole worries, and there are also worries that are attached to certain kinds of goods at the start here.

There are worries that regulation are going to get in the way of having the ability to experience the joy of overcoming fertility, or of having the opportunity of not having a child with Tay-Sachs disease, or having the ability to pursue knowledge if it turns out that regulatory activity gets in the way of those goods.

And I think the list of those concerns could be developed and spelled out so that they are not slogans, and that they are filled out here.  I think that would be a contribution. And on the question of diagnosis and description, neutrality, and the like,  I do think that if we do properly the setting forth of the human goods at stake, that a diagnosis in the sense in which Bill meant it, namely an evaluation — and not necessarily by the way, Michael, with a call to action.  Maybe the language is —

PROF. SANDEL:  I am just describing what is in here now.

CHAIRMAN KASS:  I don't read the last sentence in the same way that you do.  In other words, to say that there is now nothing in this area doesn't necessarily mean that there should be something. 

But, I mean, in any case, what follows from the diagnosis depends upon whether there is or is not an available treatment, and whether the treatment is worth the disease, and that remains for discussion.

But I do think that this document, whatever we put out, ought to aim at some kind of modestly evaluative description of how well the present practices address these various goods as we are able to describe them so that other people can understand what we are talking about.  That I think would be a contribution.  Bill.

DR. MAY:  If I may just add one point in response to Frank's use of the word, "too late."  One thinks of advances where regulation comes too late, and there is two meanings to that really possible.  One is because interest becomes so entrenched, it is very difficult to do anything about it.

There is that sense of "too late."  But in the case of this document, when you are talking about the well-being of the children who come to be born, there is the problem there of lacking knowledge.

It seems to me that there is a kind of urgency to finding out what are the longitudinal consequences of bringing into being people, and to have that kind of knowledge, there is a kind of diagnosis there that moves in the direction of a call to action in the form of finding out what the consequences are.

Because for them it is too late in another sense.  Not simply because they are an entrenched interest, but because they are human beings upon whom we may have perpetrated certain things, and which we ought to shy back from.

CHAIRMAN KASS:  Let's take a break.  If I say 10 minutes, you will take 20, and so I will say 10 minutes.

(Whereupon, the meeting was recessed at 10:10 a.m., and resumed at 10:32 a.m.)


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 laisser-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.


SESSION 7: PUBLIC COMMENTS

CHAIRMAN KASS:  Rather than take a break, since we have only three people signed up for public comment, I suggest that we proceed.  The rules for public comment are for those of you who might be here for the first time, is that are people are invited to speak for up to 5 minutes.

I have on the list the following three people:  Erin Kramer, from Resolve; Doug Hunt, from the International Center for Technology Assessment; and Nancy Trenti, from the American Psychiatric Association.  We will take you in that order, please.  And welcome.

MS. KRAMER:  Thank you, Chairman Kass, and members of the council.  My name is Erin Kramer, and I am here today to represent Resolve, the National Infertility Association, and my remarks supplement written comments that we submitted to the panel in April.

Resolve is a national non-profit organization that has for 30 years been providing compassionate support and information to those suffering from the disease of infertility.  Resolve works to increase public awareness of the issues surrounding infertility and the various family-building options available to those workings to resolve their infertility.

Resolve members are served by a network of more than 50 volunteer-led chapters across the country, providing education and support to local communities.  Infertility is a painful club that no one wants to belong to. 

Infertility is deep grief, loss, frustration, and complete sadness.  A lot was said yesterday about whether having children was a right, but I think that society can agree on — what I think that can agree on is the desire to have a family and a biological one is much deeper than the desire to have a fancy home or a car, and I hope that we don't go down that path and confuse those things.

Those needing medical intervention to achieve pregnancy or carry a pregnancy, while devastated by their diagnosis, and deeply sad, are not cavalier about their medical treatment options, alternative procedures, and non-medical therapies for building a family were compromised in making the family building decisions right for them.

We know these individuals to be careful and deliberate in analyzing the treatment options available to them, and we are offended by sensational journalism and critics of those trying to resolve their infertility that question their ethics or paint these individuals as self-serving and desperate, willing ot partake in any experimental process in order to have a baby.

Like all perspective parents infertility patients have as their foremost concern the safety of their future children and carefully consider that the actions they take can determine the quality of health, the well-being and life experience of their offspring.

We would argue that these patients make the decision to procreate with even more careful thought and examination than the general public.  Infertility patients are well informed about their care, and question in minute detail every single contingency associated with treatment, and weigh carefully the risks and benefits of each contingency, including whether another family building option is better for them.

But the desire to build a family does not incapacitate a person's ability to make appropriate and safe medical decisions, just as the cancer patient's medical condition does not complicate her ability to decide amongst therapy options. 

To suggest otherwise really does show a lack of respect for any patient's decision making ability, and besides what is so self-serving about wanting to love, raise, and provide for a family. 

Arguments have been made that the worth of these medical treatments should be fully examined or reexamined.  We are concerned about possible outcomes of this examination, and we are concerned about government policies that would deny or limit the ability to pursue medical treatment, which has been a part of mainstream medicine all over the world for 25 years.

We are adamant that this mainstream medicine should not be equated with reproductive cloning.  We are concerned about policies that show a lack of compassion for human suffering.  We are concerned about policies and regulatory actions that might dictate a moral point of view with those with different views.

Of course, Resolve supports the right of these with infertility to make the private decision regarding their medical treatment with the assistance of qualified Board Certified physicians, and Resolve supports and defends the right of individuals to be free from interference in making the very personal decisions about the uses of their own body tissues, including reproductive tissues and fertilized reproductive tissues.

Just in the same way that Resolve supports the right of individuals to build their family in the way most appropriate for them.  By the way, I know plenty of infertile couples who have examined the medical treatment option and have said no thank you, that is not for me.  I will build my family through adoption or live as a two person family, husband and wife, and Resolve supports and applauds that decision.

Resolve works to ensure access to appropriate medical treatments for all who are impacted by the disease and supports the goal of the patient in expecting a safe outcome of those procedures. 

Resolve firmly believes the current regulatory environment for these treatments works phenomenally well, and is a testament to the demands that the infertile patients have required of safe and effective treatment, the dedication of the medical profession in providing the safest edificatious treatment possible, and the profession's ongoing commitment to investigating better protocols.

Full disclosure of experimental aspects of these protocols, including known and potential risks of course is paramount.  But the debates that conclude these treatments are not safe when the million children born of these treatments proves otherwise. 

Or that these treatments do not have a place in our society perpetuates the stigmas felt from those suffering from infertility.  Resolve's primary concern is that the regulation of treatments for infertility must be balanced with the very important priority of access to the treatment, safety of the treatment, and patient privacy.

We are concerned about new layers of regulation and that may move or restrict reproductive decisions from where they should be in the first place with the patient, and we are concerned that regulation would be financed by patients when patients are already financing out of pocket the magnitude of research into infertility.

More could be done to ensure public financing of research.  A concern was raised yesterday regarding the justification about taxing the public to fund what some in the public may not support.

Yet, witness animal research, tobacco subsidies, the recent war in Iraq.  All of these are things that our tax dollars fund, and despite large disapproving portions of the public.

Public financing of research into infertility treatments will mean more information upon which couples can base their family building decisions.  I want to share with you the recent results of Harris Survey poll that Resolve was able to fund as a recipient of a grant from HHS to examine attitudes about infertility and specifically about embryo disposition and donation.

Survey respondents were a sample of Resolve members, individuals with chronic illnesses, and the general U.S. population.  The respondents overwhelmingly support health insurance coverage of infertility testing and treatment, and the vast majority of respondents also support State and Federal legislation requiring treatments to be covered even if that means an increase in insurance costs.

And there is a bit more.  Eighty-four percent believe that it should be the personal decision of the couple as to how to use their frozen embryos, 84 percent.  Nearly 50 percent of the respondents believe that scientific research is a good way to use excess frozen embryos.  And 16 percent thought that the government agencies should be involved in oversight of this process.  The Federal Government should not limit medical care to this one patient group in a matter that is unprecedented in all other areas of medicine, and family building is too important to society to allow medical treatment to become antiquated due to overreaching government intervention.  Thank you very much. 

CHAIRMAN KASS:  Mr. Hunt.

MR. HUNT:  Thank you, Mr. Chairman.  Although I am a member of the Center for Technology Assessment, I come today as a Fellow of the Ethics and Technology Program. 

I just — and I have some brief informal remarks, primarily to draw your attention to some issues that either were not raised or were only raised in the last hour. 

The first would be in your talk thinking about where the work of this program will go, is that in the paper submitted and as part of our materials by Tania Simoncelli on PGD, with respect to PGD, the U.S. is in fact a rogue nation among the developed nations of the world.

The chart that is on the back of that paper illustrates this fairly explicitly in terms of the five countries that prohibit PGD for any purpose, and the five countries that limit it severity, and then the United Kingdom, which has fairly restrictive limits on it as well.

And the U.S. as you can see, which is the bottom bar, there has been no restriction and it has of course been applied in ways that are not even permitted in most of the rest of the developed world.

And which is probably the reason that the clinics offering PGD as an option exist here in the U.S.

The next point that I would like to make — and I want to thank the Chairman for raising it in the last hour, and that is the implications of characterizing embryos and fetuses using PGD or PND as unfit to be born.

And the lack of presence here of any representatives of the disability community, whose perspectives on those issues in particular are quite important I think for you all to consider in the discussions.

The last thing is just a remark about germline, and while I generally agree that it is a technology that as described in terms of inserting cassettes and making selective changes is probably very far off, if ever possible.

That it is important to recall that French Anderson only a few years ago proposed to the RAC an experiment in which a "somatic cell gene therapy" would be carried out in utero. 

And, oh, by the way, it would probably result in a change to the germlines of the fetus.  And also to mention that there is underway at Avigen Corporation a clinical trial in treating hemophilia.  I don't remember which type.

And in which during the phase one trials the adenovirus that is being used showed up in the sperm of the volunteer subject, which also then indicates the potential for germline modification even if it is unintentional.

So while those issues, the issues of directed germline and cassette insertion may be very far off in the future, that the techniques for doing it are not necessarily unknown and may be to hand before we get there.  So I urge you to continue to consider that.  Thank you.

CHAIRMAN KASS:  Thank you very much.  Ms. Trenti, welcome to you.

MS. TRENTI:  I am Nancy Trenti from the American Psychiatric Association, and the discussion yesterday on medicalization focused on psychiatry and mental illness, and it is unfortunate that we were not provided the opportunity to testify at this meeting.

We had requested to testify and were not given that opportunity.  We sincerely hope that we will be able to testify in July to these things that were discussed in previous hearings and at this meeting.

CHAIRMAN KASS:  You do have the floor, Ms. Trenti.  I think you can —

MS. TRENTI:  Well, we have four expert witnesses who are extremely qualified in these areas, and we would like to have them have the opportunity to discuss all this. 

This is what we passed out, and this is a copy of the letter that we had sent requesting to testify, and I would just ask you to let everybody on the council and the public read it, and I wanted to find out if we will be able to have one of our experts testify in July.

CHAIRMAN KASS:  Thank you.

MS. TRENTI:  Thank you.

CHAIRMAN KASS:  Questions?  Comments?  Bill Hurlbut.

DR. HURLBUT:  I would like to comment to the last speaker that we were sent some — a letter and some information a few weeks ago.  I just want to say that I think you raised very, very important and valid concerns, but I don't think they are directed properly to us.

I for one am a physician, and I am familiar with exactly what you are talking about.  Paul McHugh is, and so forth.  We have a variety of views expressed at this counsel, and statements taken out of context can look one way, but we are certainly not trying to say and to in any way undermine the meaning of mental illness in this society.

If anything, to take it very seriously, but not let it be besmirched by a kind of mushing of what the significance of it is.  I didn't feel like your comments hit the nail on the mark actually, and in terms of our goal, we certainly affirm what you want to affirm in that regard.

MS. TRENTI:  Right, and all we are asking for is a full discussion with other experts in the field.

MS. TRENTI:  Jim Wilson.

PROF. WILSON:  I have just had a chance to glance at the letter that I received here for the first time, and much of it is devoted to Ritalin and such matters, and how does this relate to the Council's work?

I have missed 3 or 4 meetings, and so I may have missed an important discussion, but could you clarify why the discussion of Ritalin and attention deficit disorder  needs to be discussed with the council or its staff?

MS. TRENTI:  Well, it was brought up in the council meeting and it was in the transcripts, and was discussed.  So that is the only reason why we are addressing it.  I mean, it was something that was brought up before the council discussion.

PROF. WILSON:  Could you explain to me briefly how it was brought up and in what context just to catch me up?

CHAIRMAN KASS:  We had presentations on this.  We had a presentation on Prozac and we had a presentation on Ritalin, and we had several discussions of the use of psychotropic drugs and children.

Let me say that I was not planning to respond publicly, but I do think that Bill Hurlbut's comment is simply correct.   We, the staff, has had presentations not only from Judith Rappoport, but also Dr. Vitiello, who is in charge of the Ritalin project and research in children.

Dr. Nakamura has come and talked to the staff.  I think the cherry picking of comments from the transcript made mostly by one invited guest, and the attempt to discredit Dr. Diller, who is a physician who works in this area, there are various things that have been done here that I think are unfortunate. 

The council is very mindful of the concerns of the association, and we are deeply sensitive to the needs of people with mental illness.  The question of the pharmacological treatment of mental illness has not been a question here at all.

And we are not in any way trying to stigmatize or reverse any of the gains that have been made in this area.  We are interested, however, in the uses of some of these agents for purposes that are — where the indications for their use are doubtful. 

We are concerned about the difference between therapy and enhancement.  That has been the context, and I regret that people have been bothered by this, but in the exchange of letters that have recently taken place, I think we have sought to reassure, and I hope that we have reassured that there is people who are concerned about this.

Whether or not we will be taking additional testimony depends in part upon what the next parts of the agenda are and we recognize your concerns, I can assure you, that we are mindful of them.

We have gotten quite a bit of expert testimony in the area of stimulant use, and to the extent that we feel that we need more, we will get it.

MS. TRENTI:  Well, I appreciate and respect your thoughts on that.  However, it was a perfect opportunity when you had on the agenda at this meeting, this medicalization, for these experts to testify.

And it is disappointing that we were not able to, and I would hope that you will look at that, and hopefully we can testify.  And all we are asking for is a full discussion with as many people that we could have on.

CHAIRMAN KASS:  Well, we will take your suggestion under advisement.  Thank you.

MS. TRENTI:  Thank you.

CHAIRMAN KASS:  Thank you very much.  Any last minute comments?  Thanks to the troops, yeoman's service, especially the ones who have stayed until the end.  Safe travel home, and we will see you in July.

(Whereupon, at 12:10 p.m., the meeting was concluded.)

 


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