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Thursday, December 2, 2004

Session 4: Biotechnology and Public Policy

Council Member Francis Fukuyama

PROF. MEILAENDER:  Well, why don't we get started.  This is a session on biotechnology and public policy, the first of two sessions devoted to questions of regulation.  The Council has, since its very first meeting, had an interest in this topic.  It's, in fact, an interest that we have followed almost throughout our entire course.

And the question — the large question that underlies that — those discussions and inquiry is:  can we find ways to govern for the good the uses of these novel and challenging biotechnologies, repeating their benefits while at the same time upholding human freedom and dignity.

We've issued a report on this subject, Reproduction and Responsibility.  It is, in important respects, an interim report.  It was primarily a diagnostic document, though we did make recommendations in the interim, while suggesting that the conversation had to continue, about which of the various possible regulatory models might be most fruitful.

And we have today and tomorrow morning two sessions that constitute part of this Council's continuing inquiry into that topic.  Tomorrow morning we are very fortunate to have two members of the Canadian government — Health Canada, Ian Shugart and Glen Rivard, who are here today — welcome to you — and they will tell us tomorrow about the very interesting new system that Canada is instituting following legislation passed earlier this year. 

We heard something about this way back from Patricia Baird, who was part of the original commission that was looking into this.  But these gentlemen have had a hand in actually getting the legislation through and implementing it.

Today we are privileged to have a presentation from Frank Fukuyama and his colleague, Franco Furger.  Welcome, Franco.

Frank, more than any other member of this Council, has been devoted to this subject.  He is in a way the spark and the father of our inquiry.  I think everybody knows that he has also, with support from foundations, been conducting his own seminar over at Johns Hopkins.  I and several members of the staff have been privileged to sit in on these meetings.  As Frank will tell you himself, this work is the work of the two of these gentlemen.  We present it here not because it represents the thinking of this Council but because it represents important thought that should be brought to this Council.  And we hope that the conversation will help your project and that this presentation will help us in continuing to think about this.

So the floor is yours, and thank you very much.

DR. FUKUYAMA:  Well, thank you very much, Leon, for giving us this opportunity to talk about our project on biotechnology regulation, and we appreciate you and the staff attending our meetings over the past 18 months.

The presentation we're going to give you today is going to be a little bit different than the slides that are in your briefing book.  We are going to skip over the description of the existing regulatory framework, because that was actually quite adequately covered, excellently covered in the Reproduction and Responsibility Report that the Council issued.  So I think you are quite familiar with a lot of that.

We do have an Executive Summary of about 25 pages.  If Council members would like to see a copy of that, we will be happy to give it to them.  We're not releasing it publicly at this point, because we wanted to get comments from our study group first and incorporate them. 

I hope within the next month we'll actually have something ready for public release, and the full body of the study is really a massive — it's really more of a book than a report, several hundred pages, that covers the regulatory waterfront quite exhaustively.

I would like to pay special thanks to Franco Furger, who is seated to my left.  He has really been the driving force behind this project.  He has drafted most of the report, and the real research and work of putting together both the study group and the report itself are really — are really due to him.

It's entitled "Beyond Bioethics," because it was our feeling for some time that the model that was settled on in the 1970s where the scientific research community and certain areas of biomedicine were left largely self-regulating, with advice from bioethicists on the ethical dimension was no longer adequate to meet the demands of the technologies, the ethical challenges that the technologies would put forward, and that we needed to talk about the R word, the regulation word, much more explicitly.  And that is really the subject of the talk today.

Go ahead, Frank.

Now, the project has been running for the past 18 months.  We've had a series of about 11 study group meetings involving — not all of these 39 members came to every meeting, but we tried to get all of the major stakeholders that had an interest in the broad area of biotechnology, reproductive medicine, from, you know, the biotechnology industry organization to members of the President's Council, and a lot of scientific groups representing scientific research communities of various sorts, and the like. 

If you are interested, we also have a website and a regular newsletter that reports basically on regulatory and legal issues related to human biotechnology.  And you can sign up for the newsletter.  You'll get it automatically, or you can go to our website.

The study group members are being asked to comment on the report, but the — when I say "we" in the subsequent presentation, the "we" just refers to myself and Dr. Furger.  The members of the study group were not asked to actually endorse the contents of the report.

Go ahead.

This is just a screen shot of our website.  It's quite involved.  It really has quite a lot of sections, so I really do invite you to — to take a look at it.

Okay.  Go ahead.

This is an overview of what we're going to be talking about this afternoon.  We're going to define the domain of inquiry, say a few preliminary things about regulation.  We are going to talk about the ethical principles that motivate the desire to regulate, and then we're going to — actually, we're going to drop out most of that last point, regulation in other developed countries, except to talk very briefly about Britain and Canada.  We'll obviously hear much more about Canada tomorrow morning.

And then, finally, pros and cons of alternative approaches, which range from basically the status quo to creating a new regulatory institution.  We opted for the option of a new institution, but we really did want to try to be judicious in our consideration of different kinds of approaches, and then to define what a new institution might look like.

It is basically an independent agency, of which there are many scattered around Washington, but we believe that we need some innovation in incorporating new mechanisms for public participation.  So we will describe this in much greater detail.

Incidentally, this is, you know, in a way an issue that all regulatory bodies, both national and international, have been struggling with, because there's a feeling that the old mode of top-down formal regulation is not adequate to meeting the — you know, the demands of kind of popular participation and the solicitation of kind of ownership by the people in the society, the broader society that the regulators effect, and so it comes up in a lot of different contexts, not just in this biotechnology one.

And, finally, we're going to say very briefly something about constitutional constraints and some international considerations.

Now, the domain of inquiry is very similar to the one that was defined in the Reproduction and Responsibility Report.  It's technologies and medical practices related to human reproduction, not necessarily those that had the intention of producing a child, but ones that were related to it, and that includes several areas — the practice of medicine involving artificial reproductive technologies, ARTs. 

But it also includes scientific research in the area of stem cells and research cloning.  Obviously, stem cell research does not aim at reproduction.  But since the embryonic stem cells come from embryos, it obviously is related to the whole area of reproduction.  So our interest is in covering that.  I don't think you can really separate the two of them out.

And just to indicate the kinds of technologies we are talking about, it's things like prenatal genetic diagnosis and screening, reproductive and research cloning, if germ-line modification becomes possible in the future this would fall under this category, novel forms of reproduction of the sort that were mentioned in the Reproduction and Responsibility Report, you know, the fusing of embryos, the walking back of, you know, adult stem cells to oocytes, a lot of the things that seem to be in the pipeline right now.

Now, we thought that we ought to lead with this, just to clarify where we're coming from on this topic that we and this Council have discussed at great length in earlier years.  Obviously, it is very difficult to talk about regulation without getting past the issue of the status of the embryo. 

I think that the — the controversy over this may well make our effort difficult, if not impossible, to actually accomplish in this society.  And as you'll see, I think it will require a prior consensus on resolving this issue.  But just to put our cards on the table, we start from the position that's been defined in this Council as one of, you know, believing that embryos have an intermediate moral status, which means that we believe that both embryo and stem cell research are legitimate activities and can be done.

What to me "intermediate moral status" means is that embryos do not have the moral status of infants, but they are also not simply clumps of cells, and need to be treated with a certain degree of respect.  And in our view, what that means, among other things, is that they cannot be disposed of or used, except for the most important and serious ends.  We do believe that stem cell research is one of those ends that is legitimate.

I would just make a — you know, an analogy.  I think there's another category of objects that have this similar intermediate status, which would be dead human bodies, cadavers, which are, in fact, instrumentally used in medical training and other things, but you cannot casually dispose of them.  We pay a certain degree of respect.

Now, I don't want to — I certainly do not want to provoke an argument over this.  I'm just — this is in the interest of full disclosure.  This is really our starting point and the premise with which we begin this regulatory project.

Go ahead.

Now, some general considerations about regulation.  I think it's quite appropriate to be very cautious about calling for excessive regulation, because whatever you regulate you obviously get less of.  And we, above all, do not want to stifle innovation and growth, and, therefore, we think that those that want more regulation ought to really demonstrate quite effectively why that is necessary.

On the other hand, I believe that in the current climate in the United States right now, if you actually want to make progress in something like stem cell research, it is extremely important to think seriously about the appropriate institutional regulatory framework under which it can be done successfully.

There's a clear example of this.  The British Human Fertilisation and Embryology Authority is an extremely strict regulator of embryo research in the United Kingdom.  Every embryo that is produced in any fertility clinic in Britain is tracked and registered by the HFEA.  So it's a much stricter regulatory regime that exists — than certainly the one that exists here in the United States.

On the other hand, it is perfectly compatible with a vigorous stem cell research effort in Britain.  Britain is one of the leaders in this area, and I would argue that if the United States wants to be a leader it — it needs to do that also.

I mean, it needs to give serious thought to the regulation, because the regulation will present abuses happening that are consequentialist abuses of the — I mean, if you think that stem cell research is legitimate, but you are worried about the further, you know, moral slippery slopes that come from it, I think that you absolutely need a regulatory framework to put some firewalls against those kinds of possibilities.

I'll just give you this brief analogy to what we think we're doing, or the kind of juncture we think we are at historically.  In 1887, the Interstate Commerce Act produced the Interstate Commerce Commission that existed up until I think 1995 or so, which was to regulate railroads in the United States.

The Hepburn Act, in 1906, gave trucking regulation to the ICC on the grounds that trucks simply moved goods over state boundaries just the way railroads did.  And I think most experts in administrative law felt — have felt in retrospect that that was a really big mistake, because the economics and the politics of trucking and railroads were sufficiently different that the expertise did not transfer over.

And, therefore, when civil aviation came into being in the 1920s, the United States did not give civil aviation regulation to the ICC, which conceptually it could easily have done.  It created agencies that eventually became the Civil Aeronautics Board, and the Federal Aviation Authority, too, as new, independent regulators.

And that's really our argument.  I mean, you could use the existing regulatory system in the United States to carry out some of these tasks.  But it is our view that given the narrow mandate of the Food and Drug Administration and the National Institutes of Health, we do not think that that is an adequate basis of doing this.

Now, in your briefing books, you — oh, I'm sorry, we're not quite at that point yet.  All right.  Let's go ahead.

All right.  Now, this is — this next section is going to talk about the ethical principles that we believe motivate our desire to create a new regulatory institution.  Obviously, you can't say that you want to regulate something unless you have some idea of the goals or the goods that you are going to try to achieve. 

And so we're actually going to steal a page from the — you know, the Canadian approach to this that you'll see tomorrow morning and begin with, as they do, a statement of principles, although our principles are a little bit different.  And then, the principles generate a list of activities that we believe ought to be prohibited outright, as in the case of the list that was in the Reproduction and Responsibility Report, and then a series of activities that we believe are legitimate but need to be regulated.

General ethical principles — again, this will seem very familiar to members of this Council.  We put well-being and the health of children at the top of the list, above the right — we think that access to ART on the part of infertile couples is an extremely important social good. 

The million children produced by IVF have been, you know, a great blessing to those people, but we believe that the well-being of the children that are produced by this technology has a higher, you know, ethical status than the desires of the couples involved.  You know, many people would say that those are indistinguishable, because parents want healthy children. 

They want the best for their children.  And, therefore, what they want, you know, is a good proxy for the well-being of the children, but in our view that's not always the case.  It is largely the case, but there are many instances you can imagine in which the interest of the parents in having an offspring may outweigh the well-being of the child produced.  And by "well-being" we do not simply mean health in a kind of narrow physical sense.  We mean psychological and social well-being as well.

As you'll see in the statement of prohibited activities, you know, our interpretation, like that of the Council, of what "well-being" means, it means among other things being related to a — biologically related to a mother and a father.  And we believe that technologies that, you know, create children that do not have that relationship do not adequately take into account the — you know, the ultimate psychological and social well-being of the child.

The third principle, the well-being and health of women, is obviously important because there are certain risks that women take in artificial reproduction.  They are not borne by men in terms of need to — you know, for hyperovulation, and so forth.  But we put it below the first two principles simply because it's done voluntarily on the part of the women that undergo the treatment. 

And then, the next two are fairly self-explanatory — free and informed consent.  Again, as the Council pointed out in the R&R Report, you cannot have free and informed — I mean, you know, a lot of IVF, as it moves from the laboratory into clinical practice, really does amount to a form of human experimentation in which you can't really get the consent of the ultimate subject of that experimentation, which is the child. 

And it puts a special burden I think on information-gathering, and so, of course, the — you know, the R&R Report's recommendation for funding of better longitudinal studies of the health of ART children I think is really critical here and implied by that principle.

Finally, a principle that we would add is that we believe therapeutic overenhancement uses of biomedicine ought to be emphasized in any regulatory scheme.  Of course, you know, we've been through — since the Council wrote an entire study on this subject, we don't have to rehearse this.  But despite the fuzziness of the distinction in many cases, we think that it's still one that is extremely important to hold on to.

We don't believe that we need to ban or prohibit enhancement uses of biomedicine.  I don't think we would want to.  But certainly a regulatory system can bias things heavily in favor of therapy overenhancement in terms of the relative costs and the barriers over which you — that you have to overcome in proving the — you know, the safety of procedures, and the like.

Now, this statement of principles translates into several targets of prohibition — again, very familiar territory.  Reproductive cloning, creation of chimeras and hybrids, we — you know, again, as the Council did — make exceptions for certain, you know, research chimerism.  But we think that, you know, creating a chimera with an object of reproduction is something that simply should be banned outright.

Germ line, because we don't see any way that this can be done safely now or in the foreseeable future, again, the new reproductive possibilities that alter the biological relations of parents and children have to do with, you know, things like fused embryos or these new technologies coming out of stem cell research that would produce children that — you know, that did not have this relationship to a mother and a father, and then limits or a prohibition on the patenting of human embryos.

Now, the issue that would be regulated: we believe that we should permit research cloning, but that it should be carefully regulated.  Now, this is obviously a choice that many people would not make. 

I would point out that, as you'll see shortly, the difference between the British Regulatory Agency and the Canadian Regulatory Agency — in most respects they are identical institutions with very similar kinds of goals, but they differ in this one — on this one issue.

And you could create a structure of the sort that we are proposing that would actually prohibit research cloning, and would still do all of the other things.  So, in a sense, I don't want people to get too hung up on the fact that we believe that this is legitimate and simply subject to regulation. 

But we also clearly believe that PGD ought to be regulated, biomedical research involving early stage embryos, blastocysts, the kinds of things like limits on, you know, the stage of development beyond which research is legitimate — these kinds of issues — sex selection and commercialization of other elements of human reproduction.  We don't think that there should be a completely free market in the, for example, in the sale of gametes.

Now, we've skipped over — you'll see the slides in your briefing book.  We had some focus on the British and Canadian systems, but this Council has been over this.  This chart — in the full study, we have a comprehensive listing of every international piece of legislation in this area over the past decade or so.  It's an extremely long list.  This is just illustrative of some of the legislative initiatives that have been undertaken.

Four countries — Canada, Australia, the UK, and France — have actually set up new regulator — regulatory institutions in the last decade of the sort that we are proposing to do.  And virtually every other country, developed country, has passed legislation in this area.  And in this respect, the United States is a big outlier. 

We are really the only developed country that does not have legislation, for example, even on the narrow subject of cloning in place.  And many other countries have been considering this, so this is not an outlandish proposal.  It may be outlandish in the context of American politics, but certainly, you know, when we compare ourselves to even our Anglophone peers, we are very slow at working to this point.

Just very briefly, to give you a preview of what you're going to hear tomorrow about the Canadian system — again, this just emphasizes that the Canadian Assisted Human Reproduction Agency, this new agency that was just created by the Assisted Human Reproduction Act this year, sets up a new agency very much modeled on the British HFEA.

And they do very similar sorts of things, or at least they intend to do very similar sorts of things.  And, again, they differ in this one area: that the HFEA permits reproductive cloning — I'm sorry, there's a mistake there.  I'm sorry, under Britain, it's reproductive cloning permitted, not prohibited.  And Canada, reproductive cloning prohibited.  Yes.

No, I'm sorry.  No, that's right.  No, that's right.  They're both — I'm sorry, I was getting the wrong — yes, right.  The research cloning is regulated.  Sorry, okay.

Go ahead.

All right.  Now, we're going to run briefly over — I think we've got four major baskets of alternatives of how to proceed with regulation.   One is simply to use the existing statutory powers that exist in the FDA and NIH and the various state agencies. 

You'll see in the slides in your briefing book we go over all of the existing powers — I mean, you know, just very brief. Well, so that's one alternative — to take those existing statutes and reinterpret them creatively to give the existing agencies powers to do some of the things that we want to do.  That's one possibility.

The other is direct legislative intervention.  There are a number of cloning bills in — you know, that have been introduced into Congress.  There's a lot of state legislation in this area, including, you know, most recently Proposition 71 in California.  Self-regulation is an existing practice, but it is something that could be beefed up in many respects.  And then, finally, our preferred option, which is to create an entirely new regulatory authority.

Now, in terms of using existing powers, obviously it's hard to measure the cost of new regulation.  But if you go with the current system, you're clearly going to avoid a lot of direct costs of creating the new authority, and then the more important indirect costs of the opportunities forgone by the fact that you're limiting both scientific research and medical practice.

And the FDA has, for example, sought to regulate reproductive cloning by arguing that basically human embryo is a biologic that falls under their statute as something that they can regulate.  We think that there are a lot of problems with this approach, major gaps.  Again, people should be quite familiar with this.

The FDA, you know, only regulates drugs, medical instruments, and biologics.  And it's a lot of creative, I think, legal argument that says that an embryo is actually a biologic.  We have heard from quite a few lawyers that think that this would not really stand up to a court challenge.

And in that respect, you know, the NIH can — you know, in a sense has broader powers to regulate — on the basis not simply of safety and efficacy, and not simply those three categories of products. But also, you know, can make decisions on funding, you know, embryo research and the like, which it has done.  But it only covers federally-funded research, and really does not cover the private sector at all.

And, finally, there's an issue that Jim Wilson, among others has written, you know, very perceptively about in the past, which is that regulatory agencies that are created for one purpose not only have formal statutory powers, but they also develop a kind of bureaucratic culture that is oftentimes very difficult to change. 

And so if you give it a substantially different mandate, in this case the mandate to consider certain kinds of ethical issues in addition to safety and efficacy, a lot of times it's just very difficult for the — you know, the old institution to adapt to these new requirements.

Go ahead.

Now, direct legislative intervention. Obviously, Congress, if it passes a law prohibiting something like reproductive cloning, can speak much more authoritatively.  And I think it's important to point out that we would not — we do not believe that something like the status of the embryo, the moral status of the embryo, is an issue that can be delegated to any regulator.  That's obviously a very controversial and important ethical issue.  It needs to be decided by the society and not — not delegated.  And when Congress does speak, you know, we know, really, where the American public stands.

On the other hand, we believe that in the future there are going to be lots of very tricky decisions that will be put forward by new developments in technology that Congress simply does not have the expertise or the time to legislate specifically on. 

And even if they were to legislate, we don't believe that this is a good idea, because, you know, this kind of direct legislation is too — you know, it's a big hammer, and you need, I think, a more delicate instrument to make some of these kinds of decisions.

For example, the current cloning bill, just as an example of the inadequacy of the current direct legislative proposals, the S. 303 is a bill that was put before the Senate that would ban reproductive cloning and permit research cloning, human embryonic stem cell research cloning. 

But we believe that if you read the bill carefully, it is completely inadequate in terms of the regulatory oversight that it — it provides.  It basically says that any new protocols have to be given to an IRB.  And for reasons that we detail in our longer report, IRBs currently, as set up, are simply not capable of making decisions adequately here.

Proposition 71 is even worse.  I mean, this was a proposition that was deliberately designed to strip out as many institutional constraints on scientific research as possible.  I think it's safe to say it's kind of like turning over the henhouse to the foxes in a certain sense in terms of the governance structure.

And so what we're trying to do is — is think through seriously, if you didn't want to do that, what would a regulator look like?

Go ahead.

Self-regulation — this exists right now.  ART is self-regulated by ASRM and SART, the two major associations that represent the ART practice of medicine.  And, again, this is repeating stuff that was in the R&R Report.

We really don't have enough information in a certain sense to know fully how effective it is.  Certainly, there are limits to what self-regulation can do.  The other thing that's important to note is that there is no clear dividing line between regulation, formal regulation, and self-regulation.  All formal regulation ultimately requires cooperation, substantial cooperation, on the part of the regulated industry.  That's where all the knowledge of what's going on comes from.

And in many ways, the most effective forms of self-regulation operate in the shadow of the possibility of formal regulation.  And so I don't think that it's sufficient to, you know, simply throw up self-regulation as a clear alternative to a more formal structure.

And, finally, our choice for the reasons stated: in order to incorporate ethical decisionmaking or ethical considerations into the regulatory decisionmaking, we believe that you really need a new institution. And also one that will deal explicitly with the question of interest group capture and deadlock.

And, again, you know, the flip side of this is the pros of sticking with the current system, the opportunity cost of creating this new institution.  Now, we're going to go on to talk about what that might look like, if we did number 4, alternative number 4.

Our proposal is modeled on both the British and Canadian authorities.  The central design criteria is the need to avoid capture of the agency or of the polarization within the agency between various single-issue interest groups, so that it will simply not, you know, serve the interests of, let's say, the biotech industry or the — you know, the ART practice of medicine.  It cannot also be held up, you know, simply by — by pro-life groups.

Now, the rationale for doing this is really based on our understanding of where the American public is as opposed to the interest groups.  You know, there is a — in the discussion of public choice, there's this kind of debate over what constitutes the public interest.  And for many people, public interest is simply, you know, all of the existing well-organized interest groups that show up at a public hearing. 

And for reasons that we will detail in the next few slides, we do not believe that this is an adequate approach, because we think that the existing interest groups, particularly in this area, actually are not representative of the American people at all.  They are much more polarized and represent a much narrower set of views than the American public generally.

And, therefore, we take a new approach in which we give statutory power to a new independent agency that will be constituted to be able to incorporate this kind of ethical decisionmaking. 

Obviously, it will be based on the expertise and with respect to the scientific researchers and the — the — you know, the biomedical practice in reproductive medicine, but will also reflect broader societal concerns.  And, therefore, it is very important in the design of this agency to have new mechanisms to encourage public participation.

We think that the current deadlock over cloning, in which there is, you know, general agreement that we want a ban on reproductive cloning, but are very divided on research cloning, which has then prevented the emergence of any legislation whatsoever, represents a kind of political failure in this country that other countries have not been subject to. 

And we think that this actually does not reflect the interests of the American people, as far as we can tell, through empirical evidence.  And to demonstrate this, if you look at — and we cover a great deal of polling data in our study — if you look at what the American public thinks about research cloning, they are not terribly sympathetic to it in the way that the scientific research community is.

For example, if you poll Americans with a kind of neutral formulation, in which you balance the rewards from research cloning against the fact that you are destroying embryos, basically you get a two-to-one opposition. 

And, obviously, you can stack the results of these polls depending on the way you ask the question.  So if you talk about the benefits, you get to a 50/50 split in the American public.  And if you mention only the destruction of embryos, you get much higher opposition.

But the balance formulations really lead to general opposition, which means that the American public is really not at all where the scientific research community is on this issue.

Go ahead.

On the other hand, if you look at something like stem cell — embryonic stem cell research, using excess embryos, I think it is very clear that there's a very large majority of the country that is in favor of doing this.  You look at the Harris — the first Harris poll for 2004, 72 percent of Americans support this kind of research, and only 13 percent are opposed to it.  And that — you know, and public opinion has been moving in that direction as we have debated this issue.

And, therefore, the current policy is not one, you know, at least according to this poll data, that is generally supported by the public.  And what this I think is meant to illustrate is that, in fact, the current polarization that exists in Congress and in the debate on the part of the interested, organized groups, is actually much more polarized. You know, the American public occupies a much more centrist position, and I think one that would actually support our proposal to permit, for example, stem cell research, but under strict regulation. Much more than actually any of the existing positions.

All right.  So the problem of institutional design is to make the institution both independent and representative, and I suppose you should add effective, and capable of making actual decisions. 

So we have a kind of two-tier approach to doing this.  The actual power to make decisions will be vested in an independent agency.  The way that these are designed, you know, comes down to things like appointment terms and voting rules.  In many independent agencies, the President appoints members of, you know, the agency or commission.  They serve for fixed terms.  They have to be approved by — you know, by the Senate.

We have a detailed discussion, which, you know, we can discuss at greater length if you want in the question and answer session about how we think we ought to approach the creation of the board of this agency.  But our view is that it should not simply represent the existing groups, that we should — you know, that the President ought to use his discretion in this to seek as many independent commissioners that are not clearly associated with — you know, with that approach.

The second tier of this is an advisory function that has to do with mechanisms for public consultation.  Now, existing administrative law provides for this already, and it's built into a log of regulatory agencies.  The Administrative Practices Act from the 1940s provides for notice and comment, which is, you know, routinely done on — when an agency wants to promulgate a new regulation.

We think that this is not really an adequate, you know, approach.  Generally speaking, agencies, by the time they post a rule for notice and comment, have already actually gone through a consultation process with a lot of the stakeholders, and very little tends to happen as a result of the — the public input at this point.

Again, public hearings are built into a lot of decisions on, you know, things like toxic waste management, you know, nuclear — sighting of nuclear sites and the like.  And, again, the actual empirical record of public hearings having, you know, major impacts on — on decisions is — tends to be limited.

There are some newer mechanisms like consensus conferences and citizens' panels.  A consensus conference is a relatively small group of citizens that are chosen to be somehow, you know, broadly representative of the public, who actually sit — they are given information, they are brought up to speed on the nature of the technology — and then they sit down in a small group and discuss that, and try to come to a — you know, a decision on, you know, what the appropriate regulatory response ought to be.

It's an interesting procedure.  It's used in — you know, in the United States.  I guess the NIH has used it in environmental law, and other places.  It's used very extensively outside the United States, in Denmark particularly, in Japan, in Switzerland, in other countries.

The big problem with this is that if you empanel, you know, one — one consensus conference of 20 citizens, you have to wonder, even if they come to a consensus decision, you know, what that represents, because, you know, it's just 20 citizens.  And so, but it is something that has been used in rulemaking in — you know, in other cases.

And there are lots of precedents, you know, for — for all of these measures — public participation measures.  At a federal level, most of these are in the area of environmental law.

Go ahead.

We believe that we really need public participation as a buffer against interest group polarization, but that then represents — you know, raises a question of who should you consult, or who are the real stakeholders?  And as I said, many people — the answer to that would be, "Well, whatever interest group simply shows up." 

But, you know, there's been a lot of writing on the participation of NGOS and interest groups in this kind of regulatory decisionmaking.  I mean, it exists both at a national level and at an international level where there are all sorts of proposals.  You know, the UN already incorporates a lot of this sort of thing, of consulting NGOs and their various proposals to have this incorporated into WTO decisionmaking.

It is very problematic in a lot of respects, because NGOs, you know, claim to represent the public good. But they — you know, they may or they may not, and they're not accountable.  They do not, you know, have clear rules.  There is no way of knowing whether the interest groups that actually show up are, in fact, broadly representative.  There are plenty of cases where you get very good decisions, regulatory decisions, that are nixed by a very unrepresentative NGO that just happens to be very well organized and together.

And so we — you know, we think that this is not an adequate approach.  And so, therefore, in a sense we need public consultation, but one that has to be much more, you know, guided in a sense, you know, to avoid — to avoid that kind of problem.

There's a further problem in this particular area of scientific literacy, because, of course, there are big problems with simply how much the public knows about, you know, particular issues.  You know, it turns out that people don't understand the difference between reproductive and research cloning, and the like, and then they change their attitudes once they discover what — you know, what the difference is.

And so, obviously, you know, to say that you're going to consult the public means that they have to have a certain basic, you know, degree of information about the technology.  And then, finally, you would like the consultation to be deliberative, so that it's not simply polling existing, you know, strongly-held preferences, but in a way the shaping of preferences through a kind of discussion.

Again, there are problems with this, because sometimes deliberation doesn't lead to consensus.  It actually leads to greater polarization.  I don't know that there's a clear institutional solution to this, but it is a danger of this approach.

So this is our proposal, I guess in a nutshell.  The independent agency structure to require — I guess there are constitutional constraints on whether the statute can actually require this kind of balance, but certainly it would be a recommendation to the President in terms of the appointment of, you know, the Commissioners to achieve a kind of balance and independence on the part of the Commissioners.

And then, public participation mechanisms — and this is the part that I think really is new and does not exist in any existing regulator in the United States right now — deliberative panels. For example — essentially, what it does is take a — a consensus conference, and simply multiply it. So that instead of having one consensus conference, you may have, you know, a couple dozen or even larger. 

I mean, there have been cases that have been sponsored, you know, not — not in terms of government rulemaking, but in other areas, where you empanel a lot of panels that are designed to be, you know, much more broadly representative by the usual criteria of geographic representation, age, gender, occupation, socioeconomic status, and the like.  These can be supplemented by various forms of targeted surveys.

We think that, you know, the internet and new forms of technology — communications technology, give you also certain other opportunities for public consultation.  That's what the consultative college refers to, which is instead of bringing people together and empaneling them for, you know, in effect a town hall meeting, you can have kind of ongoing discussions that, again, will have to be carefully managed by the agency, but with the purpose of eliciting both deliberation and, you know, solicitation of public views.

Go ahead.

Constitutional constraints. I mean, I think the issue has been brought up by a number of people that if we actually wanted to create this kind of agency, it may fall afoul of some constitutional issues having to do with procreative rights. 

We don't believe that this is the case, because we think that the courts are likely to recognize a much more traditional understanding of any right to any procreative rights.  We certainly would endorse a fairly modest interpretation of that.  And I think that, you know, the more — I mean, there are law professors that have argued that, you know, there's a constitutionally protected right to use ART for reproduction. But we think ultimately that this will not be a barrier.

The final — go ahead.  The final slide simply has to do with international considerations.  These are issues that have been already debated in the United States at an international level.  There are various, you know, approaches to that, but we basically think that this is not the time for any consideration of international regulation.  Until you have national rules being created, it is very, very premature to talk about any type of international agreement.  And in any case, I doubt very much that you are going to — you are going to get it. 

So that is our proposal, and we welcome — we are in the process of working it.  We solicit, you know, reactions, and we hope to be able to actually publish the document, both the Executive Summary and the longer version of this, sometime in the spring.

Thank you very much.

CHAIRMAN KASS:  The floor is open for discussion.  Jim Wilson, please.

PROF. WILSON:  Frank, you and your colleagues have done, as I would expect, an admirable job of summarizing what needs to be done.  And as you know, I agree with you that a federal regulatory agency is necessary, and I agree with you that research under carefully regulated conditions on embryonic stem cells should not be barred.

My concern is with the structure of what you have suggested.  If you look at the history of federal regulation across a variety of areas, we've had essentially two strategies.  One is summarized by the ICC, the Federal Communications Commission, the Civil Aeronautics Board, the National Labor Relations Board, the Securities and Exchange Commission, all created to represent interests.

And then, we have a different strategy of single-headed agencies — the Occupational Safety and Health Administration, the Environmental Protection Agency, the National Highway Traffic Safety Administration, and others.  And as a generalization, admitting of some exceptions — I'll put the Food and Drug Administration aside, because it doesn't fit any of these generalizations — the commissions have failed, and the single-headed agencies have succeeded. 

And I think the reason for that is that you can hold somebody accountable in a single-headed agency.  And if you don't like what the EPA is doing, or OSHA is doing, you know who to investigate, and you know who to publicize. 

Secondly, we have learned from experience that when the President makes appointments to commissions, he will appoint the obvious stakeholders.  And in the case of the ICC, he appoints railroad operators, and occasionally truckers.  In the case of the CAB, people close to the airline industry.  In the case of the FCC, people close to communications.

The National Labor Relations Board is a bit different, because Democratic Presidents appoint union members, and Republican administrations appoint conservative members.  So the NLRB is the most frequently sued regulatory body in the United States, because it has a built-in degree of conflict.

So that though I am in favor of some degree of consultation, I might not go far as the deliberative panels, because they might exhaust this country's limited capacity for consultation.  I wonder if you have good reasons for having rejected a single agency head in favor of a commission?

DR. FUKUYAMA:  No, I'm glad you brought that up.  No, we are really not — that's not fixed in stone.  And, in fact, when we presented it to our study group, Ernie Gellhorn, who is a fairly prominent expert, legal expert, in public administration regulation, actually made exactly that point: that the single-headed agencies are usually much more — I mean, apart from the — you know, apart from the politics of the appointments of independent commissions. He also pointed out that they are much more effective, because you don't have to get a board of regulators to all agree on something, and get deadlocks, and so forth.

We had started out with this idea of a — you know, of an independent commission, you know, simply because that was the British model.  They've got 17 commissioners.  But I think that that's a kind of — you know, that's the sort of useful comment that I think in the specifics of the design we are looking for, because there does seem to be a, you know, strong opinion that a single-headed agency is a — you know, is a better way to go.

CHAIRMAN KASS:  Before I simply let people get in the queue to make comment, let me make an observation that might guide the discussion.  This group — it is well-known to everybody — is divided on the question which Frank, for his own proposal, stipulated. Namely, judgment on the moral status of the embryos, such that certain kinds of research would be licit, if regulated — a principle which is not universally shared here.

And when we discussed the question amongst ourselves, it was perfectly clear that — at least as I remember Gil putting it, he would be delighted to support a regulatory agency, provided he could choose the principals and name the members.

And there will be people for whom this proposal is noxious because of that particular fundamental question. And Frank has as much acknowledged the difficulty of trying to get this proposal a public hearing in this country by virtue of the national division on this.  It may be more polarized than the Congress as a nation, as a whole, but who knows until one tries.

I don't want to silence anybody who wants to raise principled objections to the entire enterprise on those grounds, and I would cede the floor to you.  But it would be, I think, useful to Frank, and also useful to us, for the sake of reflection to — because it seems to me it's possible to design such a thing in which embryo research was not the central piece of this.

So it seems to me we have an opportunity to hear — here to think about the question of how, if one wanted to try to practice regulatory activity in this area, knowing the problems of polarization, and knowing the problems of capture by the regulated, what are the ways to think strategically about how to do this — I mean, how to do this well?

Jim Wilson's first comment starts along those lines.  And I would at least like to make sure we reserve a significant portion of this time treating — sort of stipulating with Frank his assumptions — and then trying to think through the mechanism, including questions of the degree of public participation, where this should be located, and things of that sort, knowing that there are at least a significant number of you who were lost in this proposal by the second or third slide, whenever it was, and this proposal may be lost to America for similar reasons.

But it seems to me that if we're really thinking about this, that we should try to enter into the discussion in the spirit of a proposal as offered.  People are obviously free to dissent even from that chairman's suggestion, and anybody can say what they wish.  But that, I think, might be the most — it is a new thing for us to try this out.

Alfonso, please.

DR. GÓMEZ-LOBO:  Of course, I am a voice dissenting here, but I won't repeat the arguments.  What I really need is something like education in American constitutional law, or something like that.  And the reason is this — Frank, you extol the HFEA, and, to be very frank, I'm rather appalled by the HFEA. 

I remember when we had representatives here one person was heading the — the Authority, and I was appalled at the lack of reflection on the moral issues.  And you mentioned several times that there were going to be ethical issues decided by this Authority. 

So the first thing I would like to know is:  what's the point of giving this huge responsibility to a body that's going to be appointed on — I'm not sure on what grounds.  I mean, representative — you know, you gave us some leads.  But if I were appointing this Authority, I wouldn't know how to appoint it.  Probably it would end up being appointed according to political variables.

But let me go to the — perhaps the deeper issue.  I'm sure there are sensible analogies with the ICC, the FAA, etc.  But unless I'm totally wrong, none of those regulatory institutions deals with something as basic as this.  I mean, we're really dealing with human life, with the decisions, you know, life and death decisions pertaining to early stages of life.

Now, even if we grant this, what I'll call "intermediate status," which I've never understood, and you're going to have a give me a very, very detailed explanation and argument for the status and when it ends, etc. But are we talking here about something that traditionally has been directly in the hands of the state, of legislation, of the courts?

I mean, traditionally, the state is the warrantor of human life, is the institution that we, as human beings, have to protect such basic things.  And then, of course, we go to court or there's also penal law for breaking — you know, for having these basic goods.  So I'm just not sure — why delegate such important decisions that should be in the hands of the community as a whole through the Congress, through the courts?  Why delegate that to, you know, 17 members?

Thank you.

DR. FUKUYAMA:  Well, Alfonso, we'll have to have the discussion about "intermediate moral status" offline I think rather than in the — in this session.  I would simply say that right now, given the nature of American law in this area, you have delegated decisionmaking in this area to the market.  I mean, that's the only constraint that exists now.

If an IVF clinic, you know, wants to fuse two embryos and produce a child, bring it to term, that has four biological parents, there's no legal restraint on that.  There's no legal restraint on reproductive cloning.  There is no legal restraint on, let's say, taking a man's adult stem cell, walking it back to an oocyte, you know, having that oocyte, you know — I mean, having the man then be the mother of a child. 

There's no legal restraint on harvesting a fetal egg, producing a child that, you know, basically has an unborn mother.  I mean, all of these things — you know, nobody is doing that right now, but when you say, well, you know, the state ought to take a position on this, the fact is we don't. 

And so this is, you know, our attempt to say that these are extremely important issues, and we should not leave it up to the market simply to decide on whether this is legitimate or not.  And we, in fact, ought to create, you know, a mechanism by which the American public, through a kind of structured, you know, set of procedures and institutions, ought to decide whether we actually want this thing to happen.  And I guess that's the simplest answer.

CHAIRMAN KASS:  Also, by the way, just — there was a slide of some importance on part of this that I think I'm — if I'm not remembering, Frank did say that some of the very large issues were not to be delegated, but had to be decided through national deliberation, such as the question of, well, what gets called the moral status of the embryo. And that some of the larger issues in value terms would be set nationally by legislation, leaving the more specific narrow questions to the Commission or to the panel, if I'm not misremembering.

DR. GÓMEZ-LOBO:  A very brief followup.  What you say is very persuasive, but it seems to me that that's precisely an argument for legislation in the area, not for the creation of an Authority.

DR. FUKUYAMA:  Well, obviously, the creation of this Authority would have to follow on a decision.  For example, even in the more — the most minimalist understanding of what — what's permitted, you know, you do embryo research on spare embryos.

Now, as I said, the poll data seems to show that there is an overwhelming majority of Americans that — that actually favor that.  But Leon is right that our large institutions, meaning Congress, will have to decide, you know, on the legitimacy of that, and say that this is something that we as a country want to do before you can even begin to contemplate building, you know, a structure like that.

The kinds of delegated decisions that our agency would take would not be that one.  It really would be smaller kinds of issues.  For example, you know, we had this principle about chimerism.  But as we, you know, saw when we briefly touched on this issue, you know, scientists create chimeric, you know, tissues all the time. And is that legitimate or not? 

And, you know, at what point does it begin raising, you know, some delicate, you know, ethical kinds of issues?  I mean, that — I don't know whether that's the best example of this, but there are, you know, other kinds of complex decisions, or the sorts of things that the HFEA has actually, you know, passed judgment on it.  Is it legitimate to create a child simply to provide bone marrow for a sibling?  You know, that kind of issue.

And I just don't think that Congress has the capability, the time, the interest, or the inclination to pass a law saying whether that's legal or illegal.  I think that that is, you know, preeminently a kind of decision that ought to be made by this kind of an administrative agency.

CHAIRMAN KASS:  All right.  I have Gil, Mary Ann, myself, and then Mike.

PROF. MEILAENDER:  Frank, a question, just a structural question.  When you were going through the — you had several things on the pros and cons of the alternative approaches, and the first of the alternative approaches was to use some sort of existing way of dealing with it.

In two of the cons, there were "inadequate public participation" and "hard to change bureaucratic culture."  But those don't return in relation to your own proposal.  And I wondered whether they ought not return in some ways.

In terms of inadequate public participation, if I understand — now I wasn't sure, and you were going fast I know at the end, I wasn't sure if I understood correctly, but the one thing that you're adding is the consultative college, which almost sounded like an internet undertaking?

DR. FUKUYAMA:  Well, that part of it would be that.

PROF. MEILAENDER:  Okay.  I mean, if that's it —

DR. FUKUYAMA:  No.  And the deliberative panels — I mean, a large number of deliberative panels, which are basically, you know, structured town hall meetings where you'd have to give a lot of thought to, you know, balance in terms of representation and who's invited. Aand they would be deliberative, you know, empanel people to discuss these issues for, you know, a couple of days to —

PROF. MEILAENDER:  Didn't you say that some of that already occurs in other contexts?

DR. FUKUYAMA:  Yes.  I mean, you'll have some agencies that will empanel one group to do this.

PROF. MEILAENDER:  Okay.  And you're just going to do more of it, is what you're saying?

DR. FUKUYAMA:  We're going to do much more of it, yes, to make it much more representative —


DR. FUKUYAMA:  — and —

PROF. MEILAENDER:  Okay.  Well, I mean, at any rate it seems to me there are some questions to raise there.  And then, granted, there wouldn't be a bureaucratic culture in place, because you're creating something new.  But wouldn't it very quickly develop a bureaucratic culture? And a bureaucratic culture precisely about some —

DR. FUKUYAMA:  Oh, sure.

PROF. MEILAENDER:  — some issues that perhaps need to return regularly to public discussion rather than be bureaucratized?

DR. FUKUYAMA:  All organizations have bureaucratic cultures.  I mean, it's simply the — I think the nature of, you know, human behavior that there are informal rules that guide the way that, you know, people cooperate and make decisions.  And what you want to do is not to avoid having a bureaucratic culture, you want to have the right bureaucratic culture. 

And I think the problem comes up, you know, particularly when you talk about giving the FDA power to, you know, regulate things that have an ethical component, that has never been part of what they understood themselves to be doing. 

And I think the experience is that if you've gotten, you know, a group of regulators that really saw themselves as professionals, that kind of stood apart from these kinds of ethical considerations, it is really, really difficult to — you know, to get them to change.  And so what you would want to do presumably is create an institution where the bureaucratic culture supported ethical argument of the sort that we've had in this — you know, in this Council. And that would be part of the tradition of, you know, civil deliberation where you take seriously, you know, the kinds of concerns that, you know, fall outside of the mandate of the existing regulators.

PROF. MEILAENDER:  But a whole range of positions might not find their way into that deliberation, right?  I mean, there wouldn't be any reason to put some people on this regulatory agency if they simply thought that some of the things shouldn't be done that you were proposing to —

DR. FUKUYAMA:  Well, yes.  Again, you know, the composition of the agency would have to — I mean, our view is it should — is the goal should be that it should be as broadly representative of, you know, American — the American public's views of this as possible.  And as I said, that does not amount to the views of the existing well-organized interest groups, because we believe that those interest groups are way too polarized and are actually not representative.

We actually think that there's a group, you know, much larger group in the center that would be broadly supportive of this, and that's what we want to try to get at through these institutional mechanisms.  So I don't think it's that — you know, quite that whimsical.  I mean, we really are trying to make this, you know, both representative and deliberative.


PROF. GLENDON:  Alfonso's question I think reminds us of some conversations we had a while back about what other countries do.  I noticed that Frank refers to the Canadian and English systems, but deliberately bracketed the continental.

But if you recall, in a previous meeting, we saw that all of these matters are heavily, strictly regulated in the Romano-Germanic systems.  And so I think that — in my own experience, when I talk about these matters with Americans, they are surprised, as Alfonso was, that there is no regulation of that whole list of items that Frank just reeled off.

So I'm wondering, Frank, whether part of your project — I guess I'm hoping that part of your project, even in the deliberative stage, would be to try to use your deliberations to raise the public profile of the issue.  I mean, to this day, to this very day, we have people in the United States who think that Roe v. Wade only regulates the first trimester of the abortion — of pregnancy.

So this misunderstanding has been deliberately fostered by groups that have an interest in fostering that misunderstanding.  But it seems to me the same is true here, that as long as the — the actual state of affairs is not well-known, there are a lot of — of mice about playing.

So I wonder if you're thinking about, even at this stage, not just having closed meetings, or relatively closed meetings, but this is the kind of thing you could get on television with, you could — I mean, op-eds, I don't know how many people they reach, but I really think this is a hot subject. And that shock response that Alfonso had is a response that you would find in a more general public and that you would — there would be a way of educating the public to get better quality responses to the polls, and, in turn, get better ideas about the question that you and Jim were talking about.

There are many tools in the legislator's tool box.  And at this point, I think it's very difficult to say which is the right one, or what combination.  That's a very difficult technical question that is different for different areas.  But I think you might — if the public discussions should — could somehow be stimulated, you might get some guidance on the technical regulatory question.

DR. FUKUYAMA:  Yes, if I could just say  I think you're right, and one of the central purposes of our project was just to get this R word out into the public discussion, because, as I said, you know, I think actually if — John Evans wrote a very interesting book about the history of the bioethics — the whole bioethics profession.

But I think in some sense the reasons that you have bioethics advisory councils and commissions, and so forth, was a deliberate decision by the scientific research community and by the biomedical industry back in the 1970s to actually stave off formal regulation by, you know, in some sense inviting this self-regulatory model, together with, you know, essentially toothless advisory commissions.

And while I much enjoy sitting on this panel and hearing the discussions, I just think that that's not an adequate, you know — but there's been — but that strategy has been actually very effective, because any time someone has raised the question of regulation people say — you know, react as if they've seen, you know, the devil or Satan himself, and,you know, how can we talk about this?  Whereas, in fact, you're absolutely right that virtually every other developed country has, you know, addressed this much more seriously than we have. 

And so part of I think our purpose — and I'm glad that we have this opportunity to, you know, get this out, to simply put this in front of people and say, "Maybe you don't like our particular, you know, version of it, but I think we got — this is the real issue that I think we've got to address."  And not — and, you know, the more philosophical discussions I think are extremely important and rich.

But as a matter of public policy, I think this is where we've got to — you know, we've got to turn at this point.

CHAIRMAN KASS:  I am next, and then I have Mike, Peter, Paul.

One of the things that I like about the proposal, and in a way the idea behind the proposal, is precisely the beyond bioethics notion.  And the recognition that these questions are not questions that should be solved by some marriage between scientific/technical expertise presenting the shape of the problem, and so-called ethical expertise resolving it.

Anecdotally, there was a meeting at the National Academy of Sciences' Panel on Stem Cell Research, and I gave a presentation there in my own name.  And there was a dinner the night before, and one of the scientists there said, "Look," he said, "you fellows really could solve all of your problems on this Council."  I said, "Oh, really?"

He said, "Yes," he said, "you should just change the membership."  And I said, "Yes."  And he said, "Yes.  What you have to do is appoint ethicists, appoint bioethicists."  And what he really meant was the bioethicists that sit on the committee of the hospital where he is, where there really are no fundamental disagreements, and it took me half an hour to explain to him, look, the reason we have differences of opinion here is that there are real issues on which people are — are deeply divided and that are not somehow resolved by appealing to expertise.

And Gil, in a very nice little piece, responded to complaints against this Council that we had somehow politicized science or politicized bioethics, and he turned that accusation into a kind of praise, if by politicization it meant away from government by experts in these matters and a return of these questions to the polity as a whole.

So I applaud that, and I applaud whatever measures would be built into this to enlarge the public consultation, the public participation.  These are questions that really affect the well-being of all of us, though as we learned this morning one shouldn't exaggerate the ability of the public simply to understand or simply to decide with projections about the future.  I mean, there's — one should be very modest about this.

My difficulty comes with the question of what the conception of — not what the moral principles are, but what the view of moral judgment — the kind of moral judgment that such a body, since the final judgments will be left with these commissioners or with the commissioner as you will.

Sometimes, not in your account, but sometimes people say this really is a test for rule of the wise, not the experts mind you, but for people who are, you know, somehow the repository of the greatest wisdom that we can have about these matters.  And that should be the criteria for appointment.

There are people in this room who think that conditions of appointment should be governed by those capable of sound moral reasoning.  There are other people — in fact, the President when he met with us, I don't think I'm telling tales out of school — exhorted this body — we can debate whether we've been this or not — not to be sound moral reasoners, and not to be philosophers, but to be the nation's conscience in these matters.

None of those things do I hear from your proposal.  What I hear is something like a high-class National Opinion Research Center, which tries to take the temperature of the public and not function as the Burkean representatives of the public as we heard this morning, but, in fact, to find out where the public now is on these questions and take it there.

And maybe that's right, and maybe that's what it means turning these matters over to politics.  And it means perhaps finessing questions of inflexible moral principle and allowing this utilitarian country to, you know, find its most comfortable bottom.

But I guess I'd have to say that I'm slightly disquieted with such sort of large matters on the table to say that what you really want here is a group of people whose main virtue is they learn how to take the public temperature and blow with the wind.

Now, you haven't said that, but it seems to me what — what is there in the conception of this?  How does somehow taking — taking the opinion polls, or having these — you know, letting the guys who have access to the internet exercise their undue influence on this process, and actually trying to govern wisely in these matters, granting that we don't have philosopher-kings to rule, nor necessarily should we?

DR. FUKUYAMA:  Well, that's a very good question.  In a sense, that's why we had that two-tiered structure, because, you know, Jim's observations about the problems of commissions, you know, being well taken. You know, the idea was that you'd have a — actually, a smaller deliberative body that was composed not simply of the appointed stakeholders but, you know, of genuinely independent people that were capable of some degree of this kind of, you know, moral reasoning, and that would be selected for their ability to do that, that would actually have the real — that would have the real power to — you know, to make the decisions.

And all of these new — all of the new public participation mechanisms were not the point of that — you know, that smaller group was not simply to take the pulse of the public. But it was to take their input but use their own judgment — you know, combine that with their own judgment to — you know, to deliberate and to come to judgment.

So there really is a kind of two-tier — so there isn't a mechanical sense in which, you know, there are people with real statutory power simply trying to do this sophisticated polling. But it's something I think a little bit more balanced between — because I think that the other model where you simply delegate it to these wise men or women has also got a lot of problems, because, you know, they can get quite out of line with what is often the common sense, the common moral sense of, you know, the broader public.

CHAIRMAN KASS:  Good.  Jim, do you want to add something to this point?  Please.

PROF. WILSON:  Yes.  I don't really follow your point, Leon, because I may have underestimated the significance that Frank attached to these deliberative panels and the consultative college, and I hope I underestimated because I really think that's not the best part of his proposal.

I think the best part of his proposal is to go to Congress with whatever political argument will get him there.  As Mary Ann said, the average public person needs to be told that we are the only country in the world that doesn't regulate any of these things and get Congress to pass a law.

Now, Congress may well pass a law that says we're going to create this agency, and we're not going to allow research cloning.  But it will regulate all of these other things.  I don't know how the debate will come out, but that's one very likely outcome.  To me, that would be okay, because we would then begin to oversee other things.

Now, the other things that would be overseen would not be established by some government-sanctioned National Opinion Research Center.  These will be all things that Congress would decide.  Congress is very ginned up about this question.  They would start passing rules about chimera and hybrids and sex selection, and all of the other things that the ART clinics now think they self-regulate, but, in fact, don't.

So by the time the law was finished, and I would imagine it would be conservatively 50 single-spaced pages long, the Congress would have told the agency what to do.  And what the agency would wind up doing is administering those laws.

Now, I personally would hope they would allow research cloning, but I'm not optimistic.  But even if I'm wrong on that, it seems to me the debate will not be between Congress passing a general law that says, "Seek the public interest and implement it," and leaving to the agency the job of defining it.  Congress will define, as best as it could, all of these matters, and the agency I imagine will have relatively little discretion.

CHAIRMAN KASS:  Mike Gazzaniga, then Peter, then Paul.

DR. GAZZANIGA:  Yes.  So let's roll the clock back here a little bit and be concrete.  It was almost two years ago — two years ago that we had our little 10 to 7 vote, where 7 of us were against cloning of all types, 7 of us were for going ahead with biomedical cloning, with regulations, and we didn't specify what that meant.

And three — and two of them are here — Frank and Paul — were for — didn't have an ethical problem — but wanted a moratorium until regulations were in place.  Is this what you meant by "regulations in place"?  So the question I have is:  is this the kind of thing that Paul meant?  Is this the kind of thing you meant? 

And we can find out from Frank is — which all of a sudden means that we have 10 members who are for biomedical cloning, and not this, with the proper regulations in place.  Because I didn't, at the time, really understand what we meant by that, because I spend half my life trying to get around regulations.  So I —


I have an allergic reaction to the regulations.

CHAIRMAN KASS:  What did you do with the other half?

DR. FUKUYAMA:  Just on that one — you know, I didn't write a personal statement at the time that we took that vote, so I didn't explain my position.  But, you know, my position was that I was in favor of a moratorium, because I did not think it was safe to proceed with this until you had a regulatory structure in place, and I thought it would take at least four years to — you know, to produce that.

Now, that doesn't mean I'm in favor of doing it now, because this regulatory structure is just a proposal.  I mean, I think you really do need to make some progress in having in place an institution that will actually provide some real safeguards, not the Proposition 71 kinds of things, but some real safeguards.

And if we are into that process, and I'm convinced that, you know, that's reality, then in fact I will change my vote and, you know, vote with you.  But I'm not ready to do that now, because I don't think we're at that point.

PROF. GEORGE:  I think it's also true, isn't it, that Rebecca's argument was not an argument that had to do with putting a regulatory structure in place.  She's got a personal statement on it, and I don't think that the answer Frank just gave corresponds to what she said.

CHAIRMAN KASS:  Peter Lawler, and then Paul McHugh.  And we are getting close to break time, so if people want to add —

DR. LAWLER:  Yes.  I think I would be most for this in the way Jim Wilson just laid out.  As Congress would legislate extensively, and the point of the regulatory agency would be to administer the laws Congress had passed, because this is — it's an odd thing about America that on this issue the left is libertarian.  You would think that the left, as the body that — the climate of opinion that wants to regulate the excesses of capitalism, would want to regulate here big time because capitalism has so many excesses.

So in order for this to be possible, I think a bill that narrowly passed Congress because of a Republican majority and Democrats from red states voting for it out of necessity, wouldn't give us what we need.  The left has to be converted in some respects.  Mainstream Democrats have to be converted in some respects to the idea that regulation in this area is appropriate. 

And it's strange that our country has been transformed, that on these crucial cultural, social, life issues, the Democratic Party is the libertarian party now, because to listen to the Democratic Party you get this opinion:  You have sensible people, and you have religious nuts.  And the sensible people are for no regulation at all, even though — so the sensible people are not to be told what goes on in Europe, and even in Canada and Britain, and so forth.

So the first step here is for someone — Frank and his friends — to — to enhance public awareness of this.  This, more than other areas of capitalism, demands regulation because of the great possibilities for the destruction of life and for tyranny in this area.

CHAIRMAN KASS:  Do you want to hold off, Frank, and we'll get Paul McHugh's comment, and I think that's where we are.  So we'll —

DR. McHUGH:  Yes, I have a comment and a question.  First, the comment is that, yes, Mike, this is what I was looking for.  I'm looking for the building up of a regulatory system — a regulatory system that is responsive to the American people through the Congress, and should lay out right off the bat what we're doing and start putting some sense into this free market system that has all kinds of abuses to it.

And you know that, though, as well I believe there is a difference between in vitro fertilization and the use of those embryos and somatic cell nuclear transfer and those things.  I won't, once again, raise the clonote, but it lives.

Now, I have one question, and that is:  why do you start off by saying that embryos have — the whole idea about this is intermediate status for the embryo?  You just get people's dukes up.  Why don't we just get started and saying on the regulatory business, "We need a regulatory agency.  We have Jim's genius and your genius to start putting these things together and make it happen."  What do you want to get people's dukes up for?  So that's question one.

And then, it's just a question of fact, and that is this issue of polling, and views that the American people have, which have been so often wrong.  On page 10 of your things, you confused me when you said that the interest groups demonstrate that the public attitudes towards research cloning are that fundamentally people oppose it two to one.  And then you come down here and say what human embryonic stem cells, though, are — polls show that they are for embryonic stem cells.

But the question is being asked there of them, from which you have developed that idea, is "should excess embryos be used in medical research?"  And the operative word there is "excess."  And if in the process of asking that question you — you told people, "by the way, we're going to produce these excess embryos every time we have an in vitro fertilization experiment, because we're going to make 8, 10, 12 of them, and they're going to be around, and we're going to continue to make these people— do you really want to make these embryos? " What would the American public say?  I believe the American public would say, as the German people say, no IVF unless you're going to implant them.  And why not?

DR. FURGER:  If I may, I mean, it's in part a matter of how these questions have been phrased.  But generally speaking, the surveys have tended to distinguish between a possible use for research purposes of excess donated embryos as a self-contained question on the one hand, and the possibilities of — the possibility of conducting research cloning as a separate issue.

Now, obviously you can combine these two things.  But if you ask this question in a separate manner, you realize that when cloning is implied, there is much more ambivalence about the procedure, whereas a semi-pragmatic approach, the use of excess embryos for research purposes, you know, it's a lot less —

DR. FUKUYAMA:  Existing ones that are already in — you know, being stored, cryogenically stored.

DR. McHUGH:  I mean, that's something that we ought to be talking about broadly in the public. And building up a regulatory agency and hearing from the Congress as to whether they think the excesses are going to continue to become excess — because whether we're going to continue the process of in vitro fertilization or not becomes a matter for regulation.

But, anyway, I just think the way you ask that question to anybody in the — in the population, you ask them — "Well, they're going to die anyway, so there you — let's do something with them."  Everybody gets up and says yes. 

But if you say tomorrow, "Well, look, we're going to start producing these so-called excess embryos because, after all, they're accessible to us, and we ought to build them.  And when we do them, we're going to implant some, and we're going to chop the others."  Then, I think the American people will probably rise up, like they say about research cloning here and say, "Not on your life."

But that's to bring us back to what Alfonso — what you said you didn't want to develop here.  Answer me this question:  why do you want to start this off by saying something which raises a red flag about the intermediate status of the embryo?  Just tell me that.

DR. FUKUYAMA:  Well, that's — it's very simple, because I don't think you can sneak it by people.

DR. McHUGH:  Oh, I see.


DR. FUKUYAMA:  I mean, this is a proposal to create a regulatory agency that would legitimate stem cell research.  There is just no — and it will involve embryo destruction.  The most limited form of that is — is using, you know, preserved embryos in existing, you know, embryos in IVF clinics. 

But if you believe that that is illegitimate, period, then you're not going to like this proposal.  And I just didn't think that it would — you know, I mean, so I just thought it's better to be up front about the fact that —

PROF. WILSON:  Well, Frank, there's another strategy.  The other strategy is to make the list of all of the things that ARTs don't like and don't approve of, but are done anyway, and make those the subject of federal legislation. 

I mean, the only way you're going to get Congress to pay any attention to this bill is to call attention to widely-admitted abuses, regulate them, and then cross the next step, if you can cross it, which is to say, well, we've got a regulatory agency, it's working reasonably well, shouldn't we be allowed now to use excess embryos from IVFs?  You don't want to start with the IVFs.  That is a political loser.   Start with the abuses.

I mean, I don't know why we're sitting around having a talk about practical politics in Washington, D.C.  It seems so inappropriate.


I'll shut up.

CHAIRMAN KASS:  That's why we bring people from California who know something about it.

Let me make one — just one — I lost it.  It wasn't that important.

Let me just thank Franco and Frank for bringing this — this proposal back before us for discussion.  We'll adjourn until tomorrow morning.

Those of us meeting for dinner, Primi Piatti is at 2013 I Street, one street to the north and about five streets to the west.  And you're better off walking on I Street than on H, where there's construction.  Tomorrow morning we start at 8:30.

Oh, I remember what it was.  On this business about the stem cells, tomorrow morning we're actually going to hear some interesting things on this subject, which might provide a way forward that doesn't require one to lead with one's chin, and nevertheless provide some suggestions that if all goes well might command some interesting assent around here.

So let's look forward to that presentation tomorrow, as well as the presentation from our Canadian colleagues.  Let's be on time for them at 8:30 tomorrow.

The meeting is adjourned.

         (Whereupon, at 5:32 p.m., the proceedings in the forgoing matter were adjourned, to reconvene at 8:30 a.m., the following day.)

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