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Friday, April 26, 2002

Session 6: Regulation 1: Regulatory Approached to New Biotechnologies
CHAIRMAN KASS: All right. We convene for the second-to-the-last session. We will have a session for public comment beginning shortly after noon, after 12:00, but this session is an exploratory conversation on the subject of regulation of biomedical technologies. And it's a subject that Frank Fukuyama has especially been interested in.

Since I mentioned it in the first meeting and Frank prepared the — a short memo at our request, Frank, do you want to say something further about it to get started? We've had a couple other people prepare to lead off in response, but would you like to just hit a couple of high points?

PROF. FUKUYAMA: Sure.

CHAIRMAN KASS: And then, we'll take it from there.

PROF. FUKUYAMA: Yes. Well, I — you know, I must say I begin this not as any fan of regulation, but I do think it's worthwhile considering whether we need to think about a new set of institutions to regulate biotechnology.

Now there are a couple of I guess precedents for this. One is, you know, something like the Interstate Commerce Commission that Jim Wilson mentioned. Actually, I appreciate this idea that you shouldn't create institutions in the absence of real problems. I actually think that we have real problems that such an institution would address.

But it seems to me that a lot of Jim's examples actually — I'm not sure which direction they point to, because they were all cases in which you had established regulatory agencies that had to deal with a new technology and try to incorporate, you know, that into a preexisting regulatory structure.

So trucks into a system that had been designed to regulate railroads or, you know, satellite television into a system that had been designed to regulate, you know, land-based telephones. And the question is whether we aren't at such a juncture.

And, in fact, if you look at the FAA — you know, when airplanes came along, people decided that this was a sufficiently different technology that they didn't give it to the Interstate Commerce Commission, which was an option, you know, that was available at the time.

And so now in agricultural biotechnology, the Reagan administration actually had a series of meetings in the 1980s to decide whether the new, you know, recombinant DNA technology was sufficiently different that it required a new regulatory structure. And the result of that, they decided they were going to regulate on the basis of product, not process.

It wasn't sufficiently different, and I think that was a — you know, a perfectly defensible decision on their part. And so right now agricultural biotechnology is regulated by the Agriculture Department, the FDA, and the EPA.

I think that there are a number of reasons that I outlined in the memo for thinking that, you know, we're going to face a lot of problems that Congress should not have to intervene on. I mean, there are just going to be too many decisions that will have to be made for Congress to intervene the way it is intervening on the question of human cloning, which means some delegation of decision-making authority to another agency.

Besides the ones I listed in the memo, if you just think about the issues we talked about yesterday having to do with stem cells and the treatment of embryos, you know, one clear approach to — that would satisfy, for example, a lot of the concerns I have about cloning and embryos would be to establish a clear-cut regulatory structure for experimentation on embryos.

So that, for example, the line of questioning that Bill started, you know, that right now we want to do things to embryos that aren't older than 14 days, but supposing down the road someone will decide that you actually need to do something to fetuses, you know, one way of solving that — I mean, if your real worry in the short term is that slippery slope, then clearly one solution to that is to set up a regulatory structure that would cut things off at 14 days and say, no, you cannot — you know, we're going to permit cloning or stem cell research up to this point but not further, and put a break on that particular slope.

And there's actually a model out there, which is this Human Fertilization and Embryology Agency, in Britain that does that, that regulates embryo research. It regulates their IVF industry and establishes these kinds of rules for, you know, that sort of experimentation. And they've already done it. In fact, it's a 10-year old agency.

And I think that, you know, I personally do not have any concrete ideas about, you know, what the institutional design for such an agency or — you know, first of all, I'm not wedded to the fact that we need a new agency. I think simply that we need to think about it, but — and I'm not wedded, certainly, to any particular institutional design.

But I do think that it is an issue that we need to look at very concretely, because there really are holes in the current structure. I mean, the one — the biggest hole really has to do with the whole, you know, private sector and the whole private, you know, biotech industry, which does not fall under the NIH's rulemaking power, which, incidentally, the British law, you know, fixes.

There is no such distinction between public and private in the British regulatory system. And that's a problem that comes up with — you know, with an agency like the RAC, the Recombinant DNA Advisory Committee.

Janet and I were talking about this over breakfast. I think that that was an exemplary, you know, instance of self-regulation by scientists, and it worked — you know, is a system that worked, you know, quite well in its inception.

My understanding is that a lot of people that work with it now think that the industry and the — you know, the structure of scientific research in the United States at this point has outgrown that particular structure, because there is so much that's now done, you know, in the private sector.

Now, I don't necessarily believe that — I'm not trying to argue that we need more formal regulation or that self-regulation is impossible. I just think that, you know, it's a serious set of issues that — you know, that deserve to be looked at.

So let's — all right. Let me just stop there.

CHAIRMAN KASS: Thank you very much.

I have asked Rebecca Dresser to open up response with — after Frank's introduction. Please.

PROF. DRESSER: First, I'd like to commend Frank for his cogent and articulate case in favor of a more systematic approach to regulating biotechnology. In calling for added oversight, he really joins a number of other scholars and advisory groups addressing bioethics issues.

For example, in 1995, Dr. Jay Katz, a respected medical ethicist, called on the government to create a national board authorized to regulate all research involving human subjects, including funded by the private sector. The board, in his proposal, would consider big picture questions that are too broad and complex for institutional review boards to evaluate.

Others have made similar proposals contending that a national board is needed to review proposals for research that could affect the human germ line, research on xenografts, research on certain assisted reproduction methods, and experimental attempts to create human-animal hybrids.

Fukuyama writes — and this is a quote — "Deciding where precisely we should draw lines concerning technologies that have not yet come into being is not a fruitful exercise at this point. It's less important at this point to make up a definitive list of restrictions than to think about general principles that should govern the development and use of biotechnology and to begin designing institutions that will enable us to make critical decisions in the future."

I agree with this, but I do want to emphasize the challenges that are in here and the effort to settle on even general principles and institutional design.

Difficulties in carrying out these tasks are a major reason why the earlier proposals I mentioned have failed to produce national oversight systems. Let me give you a couple of examples. In the 1970s, Department of Health, Education, and Welfare created an Ethics Advisory Board to determine whether the Federal Government should fund research on in vitro fertilization and early human development.

The Board was given the responsibility to review each proposal seeking government funds. So it reviewed the topic and made general recommendations about the criteria that should govern federal funding. But then, its charter lapsed in 1980, and it wasn't renewed. And then throughout different administrations the Department of Health and Human Services Secretaries, nobody would pick this up off the desk and would appoint another Ethics Advisory Board.

So most people looking at this attributed the inaction to politics, controversy surrounding the status of developing human life, produced a reluctance to adopt explicit government policy on IVF research. As a result, the Federal Government failed to engage in oversight of research related to assisted reproduction, and this is what led to our current situation in which such research is supported by private funds, subject only to voluntary guidelines prepared by professional organizations and by the researcher's personal ethical beliefs.

A more recent example of the difficulties in establishing even general principles and oversight mechanisms concerns research involving people with dementia and other mental disorders that may affect decision-making capacity.

Many people think that current U.S. regulations are inadequate to resolve the ethical issues that may arise in research involving this population. In 1998, our predecessor, the National Bioethics Advisory Commission, produced an extensive report and recommendations including recommendations that the Secretary of DHHS appoint a national special standing panel to review certain ethically controversial proposals and supply guidance to IRBs reviewing studies involving this population.

After that, though, some psychiatric researchers spoke out against this recommendation, claiming that it would impede the search for treatments to help people with mental illnesses.

And because of disagreement, then, about substantive principles, such as the degree of risk that's acceptable in research involving people who have impaired decision-making capacity, and disagreement about the structure of oversight, whether it should be national or whether local IRBs were sufficient, because of these disagreements the DHHS has not created this special standing panel.

So I think we cannot underestimate the barriers to moving forward. So then, how do we begin the task of developing general principles and designing institutions that would apply them?

Well, first, I do think existing institutions could apply existing principles in ways that would address some of the moral issues that biotechnology raises.

As pointed out in our cloning discussions, current U.S. regulations say that risks to human research participants must be reasonable in relation to expected benefits, either to participants if there are any, or to the importance of the knowledge that the study will produce.

So the regulations incorporate this idea of justified risk to subjects. And I think this requirement to determine whether a study will generate information that is important enough to justify exposing study participants to risks offers an opportunity for IRBs to evaluate whether, for example, an experimental intervention that could increase a child's height offers a significant enough benefit to justify exposing children to physical, emotional, and social burdens in the study process.

This offers a mechanism for determining whether the potential benefits available through experimental interventions on what many of us would view as enhancements warrant exposing children to the risks present in the testing process.

FDA regulations that exist now also offer related opportunities. The FDA does require all private research sponsors seeking to test drugs, devices, and biologics to have their studies reviewed by IRBs before there is any human exposure. And the regulations direct IRBs to evaluate, again, whether the risks presented in — by an investigative drug or device are reasonable in relation to potential benefits.

FDA officials deciding whether a product is safe and effective enough to release into the market can also take into account relative harms and benefits. Former Commissioner David Kessler did just this in 1992 when he said that silicone breast implants would be available only to women who had had mastectomies. He decided that the benefits of the implants used for cosmetic purposes failed to justify exposing women to risks of this device. That is, the risks of the implants were unreasonable in relation to the cosmetic benefits.

In his judgment, implants for enhancement purposes were too risky, and, thus, unsafe. But the risks were acceptable if the implants were part of treating a disease.

Now, in defending the ruling he wrote, "Certainly, as a society we are far from according cosmetic interventions the same importance as a matter of public health that we accord to cancer treatments." So whether or not one agrees with this particular judgment, I think the case does show that existing FDA standards permit the agency to make decisions based on comparative harms and benefits available through biotechnology interventions.

Nevertheless, I do agree that broader standards than currently exist are needed to respond adequately to these innovations, and also that the current oversight institutions are inadequate to produce such a response.

Indeed, the current U.S. regulations explicitly direct IRBs not to consider as research risks, "possible long-range effects of applying knowledge gained in the research — for example, the possible effects of the research on public policy." Yet this is exactly the sort of effect that Fukuyama and many other people are worried about.

Now, of course, assessing the moral and social implications of biotechnology innovations presents daunting questions. In most cases, review groups have to evaluate potential harms and benefits to future generations, and these are effects that are highly uncertain and depend on many other variables besides technology development. I've heard them described as radically contingent.

And so settling on general principles won't be easy. For example, in Frank's materials he mentioned the precautionary principle that they use in Europe to assess new agricultural biotech innovations. Should we have a similar principle with human biotech innovations that requires some sort of demonstration that these innovations are "safe for society"? And then, what does "safe for society" mean?

How do we determine when a technology presents too great a threat to shared humanity? And these are terms that Frank mentioned in his materials as sort of general standards.

And then, also designing a review process is difficult. If we're going to assign these decisions to review groups, what should the composition be of the group? Which professions should be represented? And other kinds of experts.

If we are to include public representatives — and I do think we should — we would want to find people who are not intimidated by the experts and who can inject an independent voice. This has been a problem with IRBs who are supposed to include people like this, but it can be very difficult to find them.

We also need to recognize the cost of a good review system. I think as we are learning from our council experience, it's really tough to do justice to these kinds of activities and still keep your day job. So, again, this is one of the major problems with IRBs. Everybody has their "regular job" and is scrambling to devote enough time to this review responsibility.

So we have to think about where the resources will come from. An underfunded oversight system that looks great on paper won't have its desired effect if there's not enough money to pay for it.

And, finally, apart from this call to regulate, Frank argues for certain substantive restrictions on cloning and other biotechnology developments. At the same time, he recognizes that in the contemporary United States there are strong social pressures that favor scientific freedom, economic opportunity, reproductive choice, and improvements in health as well as quality of life.

In our democratic system, groups representing these interests will undoubtedly participate in designing the oversight system and, thus, the standards and structures are likely to take these interests into account.

My own view is that encouraging a thoughtful approach to regulation will require much better communication with the public about the technologies at issue. I think a major problem today is the failure of the media, industry, and scientific organizations to acknowledge how uncertain are the potential benefits of this technology, and also to place these developments in the context of a nation and a world that are struggling to meet basic health care needs of many people.

So, in sum, Frank's account has two elements. One is on the need for regulatory institutions, and one is on what he believes should be the desirable content of that regulation. It might not be difficult to reach agreement on the first element, but I think that substantial barriers to agreement on the second exist. And this is why I think a lot of times the institutions don't get created, because people can't agree on what even the general principles would be.

Despite all this, I do think the Council should take up Frank's charge and consider next steps. That is, what general principles should govern biotechnology research and use? And what would be the characteristics of an adequate regulatory system?

In one sense, I think our Council is a good test case. We're very diverse in our disciplines and our values, and, thus, if we can begin to answer these questions, perhaps other groups, our elected representatives, and other government officials can do so, too.

Thanks.

CHAIRMAN KASS: Rebecca, thank you very much.

Let me recognize Mary Ann and then Jim Wilson.

PROF. GLENDON: Well, I, too, am very grateful to Frank for opening up these questions of regulation and institutions, and to him for recognizing the political dimensions of the problems that we are going to be addressing. And so I would add my voice to those who encourage the Council to explore these matters further.

I think that the political discussion of regulation and institutions has to begin a step earlier with the question of priorities. I think my remarks in the last session might have been misunderstood by some of those who commented on the topic.

When I raised the question of allocation of scarce resources, I was not trying to make a point about equality, but, rather a point about priorities. And I think the beginning of wisdom in this area has got to be an investigation first of, what priorities has our society established already in the area of biomedical research and biomedical technology, either intentionally or by default? Where are we going? And then, is that really where we want to go? How are those priorities established? is a political question.

I would also suggest that as we explore those kinds of issues that we take account of the effects of a major demographic change on the politics of this whole question. I referred earlier to the aging of the baby boom, and I referred to it in the context of increasing demand for certain kinds of services that have a moral dimension.

But it has another effect. And if you look a little bit further down the line, the aging of the baby boom is causing a change in the ratio of active workers in the labor force to persons in the population who are dependent, retired and frail, elderly, very young, etcetera. That second change may very well have some very sinister implications, not only for enhancement but for other desires of the aging baby boom population.

CHAIRMAN KASS: Thank you.

Jim Wilson?

DR. WILSON: I will join in the praise for Frank, and I was especially impressed with Rebecca's very careful analysis of this. There are only a few points I can add.

My discontent with the conversation we had over the last hour — a discontent I am unable to mask because I lack sufficient control of my facial muscles —

(Laughter.)

— reflects the fact that we were not focusing on something concrete. It's not the job of this body to make rules about Ritalin or, to use an example I threw in, hand-held calculations. We're really concerned with the possibility of germ line strategies, and we must be very specific in our future deliberations in enumerating those things which are: a) sufficiently important, and b) sufficiently likely, so that we know what we may have to regulate.

And should the Council endorse cloning for biomedical research, we have to be clear about what regulatory mechanisms would be employed there. Although I think the Council will be divided on this issue, we should not pretend that the problem does not exist. So I think my first piece of advice is to the staff, let's be as focused as we can the next time we visit this question, so we can talk about these things in rather concrete detail.

Secondly, when we design or think about designing regulatory bodies, we must consult with the bodies to be regulated. That is to say, the membership of this Council need not be altered, but we must enter into some degree of informal consultation with people in biotechnology and others who are active in the field in order to understand what is happening.

One of the lessons I have learned after studying political science for 40 years is that the threat to the republic rises — is much greater when it arises from ignorance than from influence.

Our constitutional system and the courts that oversee it are well designed I think, by and large, to handle the excessive use of influence. But they're not at all skilled at handling ignorance, and we have to figure out how best to design something that will work in the practical world.

David Kessler's quote that Rebecca Dresser gave was to me an example of ignorance. In the view of many people for whom I have the greatest respect, it was, in fact, an example of duplicity when he made certain assumptions about silicon breast implants that medical science at that time had failed to support.

I think one way in which to make our efforts more focused and deliberate is for the staff, if Leon agrees, to gather information about what, if any, kinds of regulations govern or led to the creation of IVF clinics and IRBs, so that we'll have a clearer understanding of the factual or legal understandings that now govern those enterprises.

And my final remark — and I make it final because to me it's especially important — is that we must allow markets to operate in this business. We do not know enough. No regulatory body ever will know enough to manage these things. If germ line technologies are to be employed, obviously there must be some oversight as to which are appropriate and which are inappropriate.

But with respect to those that are appropriate, people must be allowed to make money doing this. Because if they're not allowed to make money, the appropriate germ line strategies will never be pursued, and people who might benefit from these strategies will never have the opportunity to do so.

CHAIRMAN KASS: Frank, did you want to join in?

PROF. FUKUYAMA: In response to that, I think there's a tremendous amount of work to be done. It was my intention, actually, in parallel with my service on this Council to, you know, get foundation funding to basically do a project, you know, that would look at biotech regulation that would do precisely that.

I mean, I have an ongoing study group that would call in regulators from the different agencies and simply to talk and inform ourselves about, you know, current problems. For example, I mean, and I think there's probably a lot of consensus that this needs to be done quite apart from the ethical concerns that we're supposed to address in this Council.

For example, you take the case of individualized medicine. The FDA, you know, as a result of completion of the human genome project — the FDA is going to have a huge problem in dealing with this, because you're talking about medicines that are individually tailored to, you know, particular genetic profiles for which the existing, you know, large clinical trial model is simply not appropriate.

And, in fact, Catherine yesterday was saying that, you know, if you extract a stem cell under her method, you know, by current FDA rules, you know, that has to be considered a separate — you know, a separate drug that would require separate FDA approval for every individual for whom you do it.

And, clearly, you know, that — there is something, you know, really wrong with that — you know, that model that needs to be, you know, I think very dramatically rethought. And so I think that, you know, one further point — I mean, since September 11th, there is a — unfortunately a security dimension to biomedical research that — in this country that I think we have not previously been — I mean, we've been conscious of, but there's a fellow that I know who is a former weapons inspector in Iraq, who is actually trying to — he now runs the Washington office of the International Institute of Strategic Studies, but he is trying to organize the global biotech industry to create a self-governance mechanism to prevent a big disaster.

He was quoting me this one example, that there is a private biotech firm in San Francisco that is trying to wrap a virus inside a bacteria in order to get the — you know, the virus past a person's immune system to obviously deliver a therapeutic, you know, vector. But, you know, obviously, it can be used as a bioweapon, and his particular concern was that they were actually subcontracting major parts of this research to a lab in the Ukraine.

And he was saying that, you know, nobody in Washington even understands, you know, the global biotech industry well enough to even realize that this is a potential problem. I mean, he said he was sure that there is nobody in the Defense Department that had any knowledge of this company and what it was doing.

So, you know, there is also I think that — you know, that dimension. And so I think, you know, for a whole variety of reasons, this is a question that needs to be looked at.

One issue that I actually had wanted to mention earlier, which is the question of democracy. You know, in general, when you deal with highly technical areas, like the regulation of biomedical research, what all democracies do is to delegate responsibility to that to, you know, so-called epistemic communities, and that's basically what this whole FDA system is and the self-regulation that goes on within the scientific community.

And that's, you know, absolutely necessary because, you know, there's a high entry price to even being able to have an intelligent opinion. You know, it depends on scientific knowledge and background, and so forth. And so — and that's the way a lot of the regulation has happened up until now.

I think the conceptual challenge is whether you can democratize in a certain way — I mean, I think that there are a number of reasons for thinking that that delegation is going to be more and more problematic as time goes on, simply because the technologies will do things that will raise ethical problems that people in the democratic — larger democratic society will have problems. Not everybody, but — and different people have different problems with different aspects of it, and there won't be complete consensus. But it'll be much more controversial.

And I think that the self-interest of the epistemic communities cannot be assumed to correspond to the interest of the society as a whole. That is to say, researchers have their own ambitions and goals. There is clearly a private biotech industry that's driven by, you know, its desire for, you know, profits, and so forth.

And so the question is: can you modify the governance structure such that it is not a pure delegation? Obviously, it has to be, you know, substantially delegated. But can you open it up to some greater degree of public participation? And here I want to divorce completely my own views of what that — you know, what the rules ought to be.

I mean, I'm just saying procedurally it seems to me that we need to think about whether there is a way of, you know, opening up that procedure and democratizing it to a greater extent, you know, and taking it a little bit out of the hands of the epistemic community to allow other societal voices to — you know, to participate.

And I think that there are some models for that. It's sometimes — when I've described this to people, they say very contemptuously, "What? You're going to have an ethics regulatory agency, and so forth?" But, in fact, you know, that is the idea behind the non-professional members of IRBs, that you get, you know, social voices that don't have the same set of interests that the biomedical research community does.

You know, the British agency also has similar rules for non — you know, professional membership in its oversight board. And so I think there are — you know, in democratic societies there are actually institutional models where you can, you know, broaden the kinds of societal inputs that — you know, that go into it.

Now, Rebecca may be perfectly right that given the deep — and, particularly, the closer this gets to abortion and, you know, embryos, and so forth, the harder it's going to be to come to any agreement whatsoever.

But I do think that, you know, and so it may not be possible to create these institutions, but I think, you know, generically that's what we're talking about. And then, there is some precedent for it, and so I think we ought to, you know, think carefully about what that might look like.

CHAIRMAN KASS: Michael? Then I'll join the queue myself. Michael Sandel?

PROF. SANDEL: Well, I appreciate very much Frank's project, and I find it all persuasive. One small request that I think would be helpful — Frank has referred to the U.K. licensing system, which applies to the full range of these, and I think it would be very helpful for the Council to — if there were a good account of that and what restrictions they've decided on that could be distributed, I think that would be a valuable thing for us to have, because there is a model out there — which we may or may not agree with in all of its aspects — but I think we should — it would be helpful if we could have a copy of it or an account of it.

The more general point, though, I would like to make is that it seems — it might seem as though Frank's emphasis on the regulatory aspects, and Rebecca's, is a separate topic from the moral and philosophical arguments we've been having.

But I think it's worth drawing out the — some important connections between the two, and to incorporate more explicitly some of the regulatory restrictions we might favor into the philosophical account, the discussion, even of the cloning issue, which we haven't really done so far.

We haven't gotten into — for example, here are two ways in which the discussions are connected. The slippery slope arguments that Charles and other — a few others have raised loomed large in the moral discussion about cloning for biomedical research.

And there are those who take seriously the worries that lie at the end of the slippery slope and also take seriously maybe even the tendencies that Charles emphasizes, but who may think there are practical ways through regulatory and licensing systems institutionally to prevent them. And if that's true or plausible, then that makes a difference for the argument about whether we ultimately endorse cloning for biomedical research or not.

Insofar as there are moral/prudential arguments, then some actual accounting of the prudential measures and licensing and regulatory measures is part of the moral argument itself, not just a further topic for a future report.

A second way in which these two are connected, the regulatory and the moral argument, goes to the — remember, we had these three categories, and group two were those people who kind of wrung their hands and had moral qualms, but nonetheless wanted to go forward. And it includes those people who in earlier discussions said there should be some respect accorded the blastocysts, even though some of us don't regard that as a full human person.

And then, the challenge comes from Gil and others rightly, well, what does it mean to accord some measure of respect if you're prepared to take it apart to kill it? How do you give actual institutional expression to the respect?

And here's another area where including discussion of the restraints that you might want to endorse and insist on, restraints having to do with the number of days, having to do with the purposes to which it could be put, having to do with whether the research could proceed if there are already existing stem cell lines of that kind out there or not, which the British case restricts, restrictions having to do with the requirement of depositing the stem cell lines in a pool rather than privatizing them, which I think the British one also includes.

It might be possible to make out an answer maybe not persuasive in the end to Gil, but at least a substantive, a more fully developed answer about how in practice people in category 2 would give concrete institutional, practical expression to the restraints and to the restrictions. And this would be a second area where spelling out the regulatory and licensing aspects would be part of the moral argument, not a further consideration to be dealt with in another report.

So I'm hoping that even in the report, which we don't have so far, on cloning for biomedical research, it's possible to try to spell out, even if in a provisional way, some of the regulatory restrictions that would be associated with what we've been calling position two, those people who take seriously the moral costs associated with sacrificing blastocysts. And, well, what does that mean in practice, and how does that differ from a view which would be indifferent to that moral dimension?

CHAIRMAN KASS: Thank you very much.

Let me make a couple of comments.

PROF. SANDEL: Could I add just one thing? The Senate debate completely ignores this. There it's either for or against. You're either for permitting the cloning for biomedical research or against, and one way this Council could make a contribution by linking those regulatory restrictions would be to show that there is another alternative.

CHAIRMAN KASS: Well, just — I didn't want to comment on that, but you — since you came a second time, let me make a small point. I mean, it does seem to me that thinking through the regulatory possibilities is part of the prudential judgment about what to do, though there is a kind of further question when one actually makes a recommendation of what to do as to whether one says there could be regulatory possibilities and, therefore, one judges this way, or one insists on being shown the regulatory possibilities in advance before one signs on morally to a particular position.

I mean, right — I mean, it's one thing to say there's a theoretical possibility that this could be regulated, and the British have done it, and another thing to say this country, given its industrial structure, its decentralized medical profession, its different view of how these freedoms should be exercised, could do this but may very likely not.

So, I mean, I take your point absolutely, and we come explicitly to the discussion of the public policy as opposed to the — I'm almost inclined to say merely moral considerations of this. The intersection of these two things I think should certainly be part of our deliberation and will be.

But let me speak more generally about the regulatory matter here. What appeals to me about Frank's suggestion, though, Rebecca's very well-stated cautions, and Jim's skepticism, and if Stephen Carter were here he would remind us always about how things wind up regulating against their original intent and worry about that.

Despite those worries, what inclines me to Frank's suggestion is this, that we meet in this room and our predecessors met in comparable rooms, and there will be other bodies like this to help people do their handwringing as the train goes forward.

But it's not clear that these considerations which are not merely abstract, philosophical ones, but are matters for the polity, for better and for worse, should find their room for expression in various kinds of decision-making, whether it be questions of funding priorities, whether it be the setting of certain kinds of boundaries within professional societies, whether it be governing the ethics of research, or what have you, whether it be at the Food and Drug Administration.

And as I see it, and we are trying to gather information, and at least the staff is slightly ahead of the Council, should the Council decide it wants to go forward here, we've at least been doing some spade work to try to find out what happened — what's going on in the FDA that might lend itself to the inclusion of considerations such as the ones we're developing here.

What is there going on in the Patent Office that affects the pace of this kind of research? What about the IRBs? And so we're trying to get background information and invite people maybe to prepare papers for us should we want to go forward on this area. But it does seem to me from where I sit that right now the larger considerations that bring us together do not have an adequate venue for consideration.

The FDA primarily had questions of safety. The Patent Office doesn't really care about even whether something has criminal uses, as long as it has legitimate uses, in deciding on its patents. And the IRBs, which are wonderful on the protection of human subjects of research, if you can't force the question into a sort of human subjects of research framework, you might not be able to get to the concerns that we have.

And the public presentation on those bodies is likely — is very often intimidated, and so on. So I don't think we — the existing structures are such that the considerations we're interested in can find adequate expression.

That's one point. So I think we — it's worthwhile thinking this through.

Second, to pick up something that Jim Wilson said about the importance of involving industry in these matters, what's really new in the 25 to 30 years since I've been thinking about this is we now have powerful groups for going forward, not just the scientists in their laboratories doing what they've always done, but these powerful commercial interests which are, for the most part, unregulated.

And my sense of this is that it is in the industry's interest — and we need to persuade them that it's in their interest — but I think it's in their interest, in fact, to join this conversation lest some of their cowboys produce the kind of disasters, the thalidomide or something of that sort, in which restrictions come down and response to disasters that will be terrible for them and terrible for us.

So we have begun to have some conversations to locate those kinds of people who could come and talk with us, and at least enter into some kind of conversation about what kinds of things they might willingly join in setting what kinds of boundaries.

And, in fact, one of the theoretical questions one wants to put to them, and we can test it out by putting it to our members here from the scientific community, is, can one begin to think constructively about the kinds of moral boundaries that researchers and technologists should observe, whether or not they take federal funds? In other words, whether they work in the private sector or not. And can one begin to think about this without threatening the goose that lays the golden eggs?

If the scientists are always saying that any attempt at regulation, or any kinds of restriction is simply threatening to our enterprise, then I think they also are in danger of running certain kinds of risk to their enterprise should disaster strike.

And it seems to me it's in everybody's interest to at least explore the question of whether we can find, if not substantive moral boundaries, at least procedures for considering these sorts of matters as the research goes forward, so that the larger considerations enter, so that the profit-makers are actually at the table, and that the working scientists contribute in a way that doesn't stifle the research but respects that the moral — the moral sensibilities of the community.

So if we can't do anything like that, then we — we will have a good time. We might produce some documents that people will read. But giving efficacy to these concerns where it really counts, I think we will just fail to do that. Whether we can succeed in this venture, I don't know. This is a high-gain, high-risk exploration, I think, because it's not clear we can — we know what to say at the end of this.

But because of its importance and its promise, I would be willing I think to invest our time and resources, if we could figure out just how to proceed in a practical sense. And it would at least help me, and I don't want to pin anybody down on this, but it would be interesting for me to hear — I hope for all of us to hear how the researchers in the group would respond to a request for a kind of inquiry on this.

So, Janet, and then Elizabeth, and Dan, if you will, too.

DR. ROWLEY: I have the impression, though I don't remember precisely, that, in fact, in one of the National Academy reports there was a suggestion that some kind of an advisory body or regulatory body could be established.

Now, I could be mispresenting that — remembering that from reading of another report. But I think that just as the individuals involved in recombinant DNA technology recognize both promise about the safety concerns in the early '70s, and established the RAC, I think so, too, many members of the present community involved in cloning also recognize many of the concerns and issues.

And particularly, because they are so much more directly related to people and the potential for uses than was clear in the '70s, that the biomedical community would — I would think, I would hope, would actually respond positively to the suggestion that they be involved in the development of a committee that would look at guidelines for these kinds of questions.

And I think that as well as looking to see what the British have done — because it isn't as though this is brand-new, others have done this as well — to look at other examples that have been successful. I noted that John Gearhart did also mention the Canadians and thought the Canadians had done even better than the Brits. So if we could ask staff to get information on that, I think that would be helpful.

And I would certainly agree with Frank and with Mike and others that in these committees that broad representation of other groups is certainly important.

In the National Institute for Human Genome Research, we have the ELSI Committee, which is the ethical and legal and moral implications of — I don't know whether the S stands for science or what, but anyhow it deals — social.

So that is already embedded in one of the NIH committees, and a proportion of the Genome Institute's research funds are earmarked for ELSI research, so that the genetics community at least has embraced the fact that what it does in the research arena is — should be viewed by communities other than just geneticists. And I think that that is appropriate.

While I have the microphone, I'd just like to go back to some of the comments that Mary Ann made, because she brought up the question of, what are our priorities? And it seemed to me the bottom line she said was these are politically dictated, and I — I wonder if, in fact, that is so.

You can say the priorities of where are we going are not determined by political forces, but, rather, by events that are driven by others, including scientists, engineers, etcetera, who come up with discoveries that then have an impact on society. And what society is doing is responding to these new areas and trying to figure out what kind of a response is appropriate rather than society saying, "We're going to go and do this kind of new thing." And so I would just question that.

CHAIRMAN KASS: Mary Ann, please, you want to respond?

PROF. GLENDON: Just a point of clarification. I didn't say they were politically dictated. I said it's a political question and something that we ought to understand as a starting point to what extent they are governed, as you say, by events — that is, by default, and to what extent there is intentionality.

CHAIRMAN KASS: Would you say another sentence? Because I'm not sure everybody understands — would understand what you mean by "it's a political question."

PROF. GLENDON: It's a political question whether a society likes the direction in which it is going, either by choice or by inadvertence. It's a subject for deliberation in a democratic polity.

CHAIRMAN KASS: Thank you.

Elizabeth, please.

DR. BLACKBURN: Yes. I really very much want to endorse what Janet just said. Leon used the phrase "all scientists" — I forget, but I think it's been very clear from the history that scientists have had a strong voice in wanting to self-regulate — the RAC being one example.

And to answer your — you said you wondered if there was something in the National Academy's recent report on — this was the report on stem cells and the future of regenerative medicine. Included in our handout were the first three chapters excerpted but not the last one, the findings. But I have the original with me, so it — let me read you the recommendations, which directly are pertinent to this.

So the recommendation after finding six was a national advisory group composed of outstanding researchers, ethicists, and other stakeholders should be established at NIH to oversee research on human embryonic stem cells. The group should include leading experts in the most current scientific knowledge relevant to stem cell research who can evaluate the technical merit of any proposed research on human embryonic stem cells.

The roles for the group could include evaluation of potential risks to research subjects and ensuring compliance with all legal requirements and ethical standards.

So I think that perhaps an implication that might have been taken from Leon's phrase of all researchers, which the scientists are not interested in self-regulation, I think that's — this is just manifestly arguing this is not the case, that there is serious interest in self-regulation.

CHAIRMAN KASS: Dan, please.

DR. FOSTER: Well, I think the idea of having industry involved here is a very good one for dialogue. Most of these — most of big pharma have ethical committees associated with them. But my view, Leon, would be in this dialogue that you probably ought to have somebody from big pharma that is not so much — they buy biotechnology, and so forth, but they're not as much in it as they are in the small start-up companies, and so forth.

So, I mean, I think that, you know, you get somebody from Tularec or Genetech or something like that as well to come in — would be very helpful to — both to let them hear what we had here and what their suggestions would be about that. So I personally think that would be a very good idea for us to do.

CHAIRMAN KASS: Thank you.

Mike, Alfonso, and Gil, please.

DR. GAZZANIGA: The shortest remark of this panel: I agree with Janet.

CHAIRMAN KASS: Alfonso?

DR. GÓMEZ-LOBO: Yes. I want to voice a brief concern about the regulatory model which consists in appointing committees. And I'll just do it by mentioning the fact that some colleagues of mine, British moral philosophers, have serious doubts about the human fertilization and embryology agency, because, you know, who gets appointed there is really crucial.

And their criticism is that rarely, if at all, people who are known to stand for protection of embryonic life get appointed. So, I mean, it ends up being a kind of rubber stamp for a number of projects that are morally very questionable. So I think that's something to keep in mind.

CHAIRMAN KASS: Who was it? It was Gil and then Paul.

PROF. MEILAENDER: Actually, I think it was Paul and then Gil, but I'll go ahead of him again, as I did once before.

Two comments, the one very brief. It seems to me if we're going to pursue something along the lines that Frank has discussed seriously, we may need to set aside the language of self-regulation. That's just clearly not nuanced or sophisticated enough.

I mean, Frank talked about how you have to — you do have to delegate, to some degree, decisions to people presumed to have expert knowledge. But there are questions about how much you delegate, and so forth, and the language of self-regulation will not capture that I think, and we need different language.

The other thing I was going to say is just it relates to some things that worked their way through Rebecca's presentation responding to Frank. And, I mean, what he has done is really nice, but I just never know how to — what I myself think with respect to a certain kind of problem.

It just seems to me the conversation will proceed much more easily with some kinds of questions we might think about regulating than with others. And what I mean is we have fallen into a pattern in this country that isn't very satisfactory, but you understand why, with respect to certain kinds of questions, say ones that involve embryos, for instance, where we don't fund — we don't use government funds in a way that would implicate all of us in some way.

But we also don't say, well, no, you know, we're prohibiting it, and we allow private research to proceed. That leads to sort of a chaotic, not very satisfactory situation. On the other hand, it's rather understandable why we've gotten there.

And if we were going to fund and regulate, once law does that it confers a certain kind of legitimacy, and that creates its own set of problems, then. And I don't — I mean, I just — I have never quite — I don't like any of the alternatives. I have never quite figured out how to get past that problem.

It will be much more acute with some kinds of questions than others in terms of the range of issues that Frank has drawn up. But that problem of complicity that — the legitimacy that law confers is always going to be hard here.

CHAIRMAN KASS: Paul?

DR. MCHUGH: I want to — I'm glad to follow after Gil always. But I also am pleased to follow after him now, because in relationship to what's being said about self-regulation, the — in the pharmacological and neuropharmacological realm, the largest organization in our country is the American College of Neuropsychopharmacology. And I'm the present sitting chairman of their Ethics Committee.

And I believe that it is a developing program in which issues that are problems are seen first, and then later dealt with. And I think the process and the willingness of such organizations is quite clear.

CHAIRMAN KASS: Well, I guess I'd like to underscore in part Gil's point on this, too. The professional self-regulation — there's a certain homogeneity of viewpoint as to at least what the domain is. This is quite apart from any particular vexing question such as the embryo-related questions would introduce.

But there is a certain kind of guilt mentality in those things in which the larger considerations that come out when you have a group of this sort talking don't generally get built into the conversation. I'm always surprised by what I hear about the table — that is to say, that very smart and thoughtful people interested in the same topic don't see it in the same way.

And if I simply hung out with, you know, the like-minded, professionally or otherwise, the questions just wouldn't look the same, and the industrial self-regulation, where all of these various institutions have their own ethics committees — I mean, it's — you get what you pay for very often in those places, and it's a very peculiar thing to have critics — it's like the company union very often.

And without impugning the judgments of anybody who works there, it is somewhat odd to bring in house people who, after the due wringing of hands, will endorse what the company is — the most profitable course.

Okay. And then, finally, the RAC is a wonderful but very limited example. It's limited by the fact that the question — this touches on something Frank said earlier. The question — the RAC grew out of the concern which led to the Asilomar Conference, in which, strangely enough, I think everybody saw that they were somehow in the beginning — at the threshold of the genomic age. The word didn't exist, but that this was the beginning of something very large.

There was anxiety about this very large thing. There were public critics of this very large thing. And all of the anxieties were allowed to be focused on the one question of the safety of the little recombinant organisms, should they get out of the lab.

And there were, of course, local threats in Cambridge, Massachusetts, etcetera, etcetera, that may have focused — but, once again, the question about the safety of the organisms, just as the safety of cloning, don't go to the heart of what it is that one actually is concerned about once the technologies are safe and ready for use. It's the use of the powers when they're safe rather than the hazards of making them safe.

And one of the things at the Asilomar Conference, several Soviet scientists were invited to this conference, and they sat in the front row and photographed all the slides. They didn't say a word.

And because the scientists, in their decency and naivete, thought that the only question under discussion was the safety of the microorganisms that were being engineered for use, no one paid any attention to the implications for possible bacteriological warfare that were implicit also in the kind of research.

But there were other people at that meeting who somehow understood the other implications. So it seems to me that these models that we have before us are interesting, they're appropriate for their place, but one has, I think, to renew the consideration in the light of our present circumstances — self-regulation, where possible, but with the input of — with the kind of input that's commensurate with the subject and with the stakeholders involved.

This is not, by the way, to suggest that the recommendation in the stem cell report would be inadequate. That wasn't meant to suggest otherwise.

Frank, and then maybe a couple of comments, and then we will move to — if there are others who want to — Charles, did you want in on this as well? Is that a light? No. Frank, and then —

PROF. FUKUYAMA: Well, just on the question of self-regulation, I wouldn't banish it from our lexicon, because it is, you know, a possible institutional model. And I think in, you know, the field of public policy there has been a lot of kind of theoretical work done on where self-regulation works and where you need more formal types of regulation.

And there's actually a lot of game theory behind this, because, you know, generally speaking, self-regulation works when communities are relatively small and homogeneous and, you know, where the kinds of issues that they're regulating, you know, don't pass a certain kind of threshold with regard to, you know, the politicization, and so forth.

So that, for example, in the standards world, there is just an amazing amount of self-regulation all over the world in terms of, you know, coming up with technical standards for all sorts of things. And this never reaches a political level, and it's all done, you know, pretty much by insiders.

But there are other situations where you have heterogeneous interests, where you have cultural differences, where you have national differences, where the issues are more inherently politicized, where these kinds of self-regulating informal mechanisms tend to work less well.

Just an example is the internet. The internet, when it was run by a bunch of engineers, could be completely self-regulating because they all agreed with each other. They all knew each other personally, and, you know, they could make decisions among themselves. But as the internet has gotten commercialized and more heterogeneous, that kind of solution tends to work less well.

So I just think — I mean, this is one of the — you know, but there's a lot of — there's a big body of thought, you know, that has gone into this more general question of when you can self-regulate and when that's not appropriate.

CHAIRMAN KASS: It looks like we may have exhausted this for today. Do I have the sense of the group that this is a topic to which we don't make a definite long-term commitment at this point, but we are interested in it enough to take it to the next stage, to gather the information about what's happening in Canada and in Britain in this particular area to invite in people from perhaps some of the bodies that already do practice regulatory activity in the area of biotechnology? And maybe set aside some time at the next or the meeting after next where we go into this more deeply?

Charles?

DR. KRAUTHAMMER: We could also sort of think of it as we may not want to look at this as an issue to be spoken of in general, but to apply it to the specific questions as we come along. For example, when we get to deciding on policy for cloning, it would be appropriate to hear, for example, what Michael and others were talking about in terms of regulating from those who want to go ahead and continue to make it legal.

So I think it would — rather than speaking of it as a global issue, I'm grateful to Frank for introducing it, because we had really overlooked it. But to take it in pieces as we go along issue by issue, and then we'll — by the end of that, we may have some idea of what a larger regulatory structure would look like having examined a few examples of what it might do.

CHAIRMAN KASS: Very good.

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