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Friday, June 13, 2003

Session 5: Biotechnology & 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.)




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