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Meeting Transcript
June 20, 2002

Ritz-Carlton Hotel
22nd Street, N.W.
Washington, D.C. 20037

Thursday, June 20, 2002

COUNCIL MEMBERS PRESENT

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

Elizabeth H. Blackburn, Ph.D.
University of California, San Francisco

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


Daniel W. Foster, M.D.
University of Texas, Southwestern Medical School

Francis Fukuyama, Ph.D.
Johns Hopkins University

Michael S. Gazzaniga, Ph.D.
Dartmouth College

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

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

Alfonso Gómez-Lobo, Dr. phil.
Georgetown University

William B. Hurlbut, M.D.
Stanford University


Charles Krauthammer, M.D.
Syndicated Columnist

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


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

Gilbert C. Meilaender, Ph.D.
Valparaiso University

Janet D. Rowley, M.D., D.Sc.
The University of Chicago

Michael J. Sandel, D.Phil.
Harvard University



INDEX

Welcome and Opening Remarks


WELCOME AND OPENING REMARKS


CHAIRMAN KASS: I'd like to ask Dean Clancy, the designated federal official, to open the meeting, please.

MR. CLANCY: Thank you, Mr. Chairman. And welcome back to Washington, everybody.

I am happy to confirm that once again, Mr. Chairman, you have obeyed the laws of the republic, and this meeting may go forward.

I say that without any surprise.

CHAIRMAN KASS: Thank you.

And welcome to members of Council and members of the public, to this, the fourth meeting of the President's Council on Bioethics.

At your places you will have some supplements to the briefing book which contain fuller biographical sketches of some of our people and a paper by Professor Arti Rai on the patenting matter, which we'll be taking up tomorrow.

You should find that at your place. If you don't have it, please let us know.

Also, before we get started, I would like to introduce one new member of our staff, Joshua Kleinfeld, who has just joined us. Welcome, Josh.

This first session is our second session on regulation on genetic and reproductive technology, some international models. The purpose of this session is to inform the Council with a view to our possible project on regulation of biotechnologies.

I remind you at the last meeting we had a general discussion of regulation, prompted by Frank Fukuyama's materials, and the idea behind our considering this topic is, first of all, that most of the ethical and social challenges of the future seem to us not to be suitable for legal proscription, but rather for oversight and regulation.

And, second, that the larger challenges and concerns that are of interest to us are not now the proper business of our existing regulatory mechanisms, or at least that's our suspicion. We're going to try to find out in the months ahead by having presentations on IRBs and probably Food and Drug and various other matters.

So we are interested in finding out about how other countries have dealt with the challenge of regulation.

Two or three comments by way of introduction, and then I think we should just proceed. The discussion we're going to have this morning does bear upon our ongoing interest in cloning and in stem cell research, but we are also interested in the broader question of institutional regulation, as such. So I want to make sure that that's kept in mind.

Second, the question of regulation, though it is about science and technology is actually really a matter of governance and politics, and therefore, it's going to be about the relation between government, academic science, industrial science, and general industry.

And the relation amongst these various groups in the United States is perhaps unique and rather different from what we will hear about in other countries. So it's, I think, of special interest to us to see how much of what is available elsewhere might be relevant to us here, why and why not.

In this session, we want to learn as much as we can about how other countries have dealt with the regulatory challenges of biotechnology to find out if we can something about the success or failures of their approaches, to see if we can learn something about how those approaches might reflect the general attitudes about the relation of regulation and government, and how this might be similar or different to the United States.

That's not the task for the presenters, but that's what we are trying to assess, and in the long run to see whether the lessons of these other models might be applicable to the American context both as models to be followed and perhaps as mistakes to be avoided.

We're very fortunate to have with us this morning two people who have worked very hard and long in this field. Lori Knowles, who is the Associate for Law and Bioethics at the Hastings Center; Lori is a lawyer with wide experience in international law. She was a consultant to the NBAC on exactly this topic. She's the Director of the Hastings Center's major project on comparative regulatory practices in reprogenetics, and the report is in its final stages and will be issued soon.

Second we have Dr. Patricia Baird, who's University Distinguished Professor at the University of British Columbia, a pediatrician and medical geneticist. She served as the chair of the Royal Commission on New Reproductive Technologies, which is responsible for the policy recommendations now under consideration for the national government of Canada.

We will proceed, I think, with Lori Knowles going first to give us the general overview of the international scene, and then Dr. Baird will speak about the Canadian experience.

And I think we probably should have both presentations in order, and then discuss them together.

Please.

SESSION 1: REGULATION 2: GENETIC AND REPRODUCTIVE TECHNOLOGIES: INTERNATIONAL MODELS

MS. KNOWLES: Well, thank you very much.

Can you hear me?

Thank you very much for inviting me to speak with you today, and I'll just bring your —

CHAIRMAN KASS: Can she be heard in the back? Good. I'm sorry.

MS. KNOWLES: Thank you.

And I'll just bring your attention to in the handout portion the supplementary material. I provided a copy of the overheads so that you can follow along on them if you prefer rather than looking up at the screen.

And I'll also bring your attention to and obviously in your briefing books you've seen there are two fuller papers that focus on international stem cell regulation that I wrote at various points in the last three or four years that will give you some more detail.

Well, we have actually just been discussing why we are looking at the regulatory frame works, and so I'll just say that it's worth, in my opinion, making international comparisons because some systems work better than other systems. Some allow for new scientific developments, such as those we've seen in the last three or four years, to be incorporated easily without disrupting the system, and some do not. You have to rewrite the system.

And some provide a high quality of quality control and patient protection, and some, of course, don't provide such a high quality. So it's worth making the comparisons to see where the strengths and weaknesses are. And some of those we can teas out obviously through Dr. Barrett's presentation and through discussion afterwards as well.

I've been asked specifically to focus on four countries, with particular emphasis on the United Kingdom and also to touch on Canada, Germany, and France.

And sine Dr. Barrett is going to talk about Canada, I'm really just going to make a few statements about that so that we don't duplicate our material too much.

And we'll be looking at how the systems are structured and how regulation, particularly of embryo research, is structured. And I'm just going to tease out then what the implications are for the various legislative acts, what the implications are for human reproductive cloning, and for therapeutic cloning, which I understand you're giving a different name, which I think is actually appropriate.

And then I'll end with what commonalities we can find that might guide such an endeavor here should you choose to embark on that by looking at sort of common guiding principles, common limits, and common prohibitions that you'll find through some of the regulatory frameworks in the other countries, including those that we won't actually be looking at in detail.

So, in general, I've pulled out what I think are six major regulatory frameworks, the first of which is a nonlegislative framework, no over arching legislation of any particular sort, but a guiding in some respects by ad hoc judicial precedent, legal cases, for example, the disposition of frozen embryos after a couple of divorces. We have cases that talk about consents, et cetera, in situations like that that provide some guidance.

And that's usually coupled with local or regional regulation, and here I'm talking about IRBs. In Canada they're called research ethics boards, REBs.

So that's one type of framework, not particularly comprehensive and not necessarily coherent because, of course, it varies from region to region and case situation to case situation.

Secondly, there are regulatory frameworks that use very specific targeted legislation for each different application or issue. So, for example, cloning legislation, human reproductive cloning legislation, many countries have this, or embryo research law that looks specifically at embryo research and provides prohibitions or limitations.

The third is an assisted reproductive technology legislation, a more comprehensive look at a use of embryos generally in treatment and in research, and the sort of paradigm case and country for this is the United Kingdom. So I'll be spending some time looking at a more comprehensive ART legislative scheme.

The fourth is human subjects research legislation that looks, for example, at the use of fetal tissue and human subjects research and a use of embryos, use of in utero or human subjects research as well.

And so you can find some countries that focus on that framework as their way of looking at how one should use embryos or embryonic tissue.

The fifth I have in brackets because I don't consider it necessarily a regulatory scheme, but in almost all the countries that have a regulatory scheme, you have advisory panel or commission reports usually that precede a regulatory scheme, and in this country we have some of those, but they don't fall into then a larger regulatory scheme, and hopefully that's what this body will do at some point.

And the sixth is perhaps the most common, which is a combination of all or some of these. Specific legislation, comprehensive ART legislation, human subjects research, which compliments it, advisory reports that go before it, judicial precedent, et cetera.

So most countries have a primary legislative framework and then some supplemental regulation of some sort as well.

Now, this chart I'm not going to run through, but essentially it shows you where much of the work is done in some of these countries, and you'll see that a lot of the countries are looking at putting the primary emphasis on ART legislation as the context in which to regulate embryo research and embryo use.

Many countries actually have regulation that's in progress or legislation that's in progress. The Netherlands just came out with a research embryo use statute last week. So a lot of this is really very, very current.

So now let's look at the comprehensive ART legislation at the paradigm case, the best example, which is the United Kingdom. This is the oldest comprehensive ART framework. It's been extremely successful because of the way it was drafted. It was drafted with very general, broad recommendations, and discretion given to the over arching authority, the body that would, in fact, direct the work to make individual decisions. So I'm going to talk a little bit more about that, and it's often copied as the model.

The act that guides this is the Human Fertilization and Embryology Act, which was put into place in 1990, came into effect in 1991.

Before the act, as a historical footnote, there was the first advisory report of its type, the Warnock Report. That's the short title for it, which was published in 1984. So you'll see there's always some sort of gap of time between the time when the commission reports are published and they can actually get the legislative framework up and running.

And I'm sure Pat is going to mention that. Canada has had a long gap in time with lots of attempts.

And this is interesting the way this was structured. It was created as a non-departmental public body. So it has a degree of political independence that has proved to be quite successful and quite useful, and it's not answerable to the Department of Health, but it is accountable, as I'll mention later on.

And this non-departmental public body is called the Human Fertilisation and Embryology Authority, the HFEA. That's what we're going to call it in our discussions.

The scope of the HFEA is both private and public. So it's not related to funding as things are in this country, but private and public clinics and laboratories. So it is extremely comprehensive in terms of application.

And the act actually set up a licensing scheme for the following areas: treatment services, so clinical work; storage of gametes and embryos, clinics of course and laboratories; and embryo research.

So you have all of these coming under a licensing scheme which has proved to be quite, quite successful.

The act also sets out limits and restrictions on the use of embryos. An example of the limit would be that you need donor consent to be able to do things with the embryos or that you need local IRB review before an application comes forward, and an example of a restriction would be that you can only use research on embryos up to a 14-day period outside of the human body. That's what I mean by restrictions.

And the violation of the act is a criminal offense. So it does have some significant sanctions, usually fine and/or imprisonment, and a violation of the act would be operating without a license, for example.

Now, the HFEA, this is the authority we're talking about, the over arching body. The membership has 23 members. So it's quite a large body, and in the act, it's written that there must be men and women on the authority, and in fact, there's about 60 percent women on the Authority, which is significant.

And it's also stated that the membership must be predominantly nonscientists and nonclinicians. That's also quite significant because they'll be working with scientists and clinicians. So they get significant input from the community.

And in fact, speaking from people who are on the Authority, there's quite a bit of partnership between the scientific and the clinical community and the Authority. It's really a working relationship that they have.

And the Authority is appointed by the Secretary of State, the membership is, and it is accountable to the United Kingdom, the British parliament through the Minister for Public Health.

So there is accountability, even though even though it's outside of the department.

Now, the functions of the Authority — we're talking about the Authority here — are to license these various things, this treatment services, the storage and the research, divide licenses through licensing committees. They don't do it all in the full Authority. They have specific licensing committees composed of five members.

And clinics are licensed for up to three years to provide particular treatment. So it's quite specific what their license covers.

The secondary function is or second, not secondary; the second function is to monitor and inspect the premises and the licensed activity. So there's significant sort of surveillance and enforcement in the act, as well, that the Authority is responsible for.

And thirdly, they maintain an information registry, which includes information about donors, of various reproductive materials, about the treatments, and this includes outcomes, as well. They really do follow and monitor the treatment outcomes and the research outcomes, and children born from treatment.

This is relatively high degree of follow-up and information that's available to actually the public and other clinics through the HFEA and to the government.

Additional functions are a standard setting function. They set standards for the practice of ART through a code of practice that they're responsible for developing and maintaining and making sure that this code of practice is guidance for clinics about the conduct of license activity that is expected.

They have an education function, which is to advise and inform patients and donors and clinics. So it's quite a wide function, and to report to the government. They're accountable through an annual report to the Secretary of State.. So it's quite comprehensive.

Now, interesting, I put this last because it is interesting about the policy making aspect of the HFEA, and they are expected to make policy with respect to novel issues. This has not been something that goes to the parliament. It's at the level of the HFEA.

And in order to avoid a novel issue that comes through a protocol going to a particular licensing committee, which would then make policy for the country — and there's only five people — that's a bit of a statutory problem that they had because the protocols come through to licensing committees.

They've worked out a relationship where when there's a novel issue that's raised, before the licensing committee actually looks at it, it gets referred up to the full Authority; that before they look at it, they give it to a working group.

So they give it to a working group on new reproductive technologies, or they give it to the ethics committee, or they give it to the code of practice committee. But some working group will look at it, discuss the fact that there are ethical and new scientific issues involved.

Then it goes to the full authority. They then provide guidance and opinion, and then it goes to the licensing committee. So they've really worked out a way that a novel issue gets appropriate treatment and input from a wide group of representatives and from those who have particular expertise in an area.

So with respect to the embryo research, prior approval by a local they're called research ethics committees in the U.K. — it's an IRB equivalent — by local IRB is required before an application will be entertained or considered by the authority.

So there is an initial vetting to make sure that a certain level is achieved, and individual research protocols are licensed, which is different than the treatment scenario where a facility is licensed and an individual is responsible.

So it's the protocol that's licensed in the research orientation.

Now, significantly, only the purposes that are specified in the act are available for licensing with respect to embryo research. So they have specified specific purposes for which embryo research protocols will be entertained and only those purposes.

I have a star on that because those have actually been recently changed, and I'll talk about that in a minute.

But the purposes include essentially the advancement of knowledge or the improvements of treatments related to infertility, congenital problems, contraception and miscarriage. So a whole range of reproductive issues.

And secondarily, detection of embryonic genetic and chromosomal abnormalities. That's a purpose for which embryo research will be entertained, and the included — and this is quite significate — the sort of general rider, such purposes as might be added by regulation or through regulation.

So they kept a window open recognizing that at that point, they believed they had covered all of the purposes, but there might, in fact, be other purposes that they would choose to include later on for embryo research, and in fact, that's what's happened.

This I want to underline only because it's proved to be extremely successful and an extremely flexible approach. So rather than licensing or — excuse me — permitting certain specific techniques with respect to embryo research, they included purposes.

And the purposes then allow specific techniques to fall into the various purposes as the techniques are developed. So it's a much more flexible approach than allowing specific techniques to be used.

With respect to reproductive cloning and stem cell research, cloning is actually forbidden. Reproductive cloning is actually forbidden under the act. However, recently, last year, in the U.K. they passed the human reproductive cloning act which specifically prohibits human reproductive cloning.

And they did that on the recommendation of some advisory committees because they felt that there was more legislative and symbolic importance in having a specific act to say this we think must not go forward rather than just having it fall under the particular act. So that's significant.

And purposes recently have been added to the act. I was just mentioning that, that allow therapies unrelated to infertility; embryo research to be conducted for therapies unrelated to infertility. So, for example, to address mitochondrial disease.

And of course, they were doing this in the context of the embryonic stem cell debate.

So the third point I'm going to make is that the language that's chosen with respect to a particular act is very significant because the definition of cloning that's in the U.K. act didn't actually include what we call SENT. It was slightly different.

So there was some challenge as to whether this would be covered or wouldn't be covered, and that, of course, is the limitations of making your language very specific or not specific enough as the case might be.

And recently, as well, there was a challenge to whether the products of cloning techniques fell under the definition of embryo in the U.K. because it was defined as the products of fertilization.

So in fact, it sounded like it didn't fall in, and there was a challenge, and it went to the high court, and the challenge was upheld and went to the appeal court, and in fact, they held that it actually fell under the act.

It's obviously very good that it did fall under the act so that they could regulate this area of technology, but I'm not so certain that there wasn't some real legitimacy to that court case to begin with.

So that's important. How you define embryo in all of these acts is extremely important because, of course, that's shifting ground.

The next point is that in the U.K. it's possible to create embryos for research, and this is quite unusual because many countries draw the line and say there is a supply, ready supply, of embryos from surplus IVF embryos. So we should use those rather than create new embryos, but not in the U.K. The U.K. is extremely liberal with respect to scientific freedom, and they permit the creation of embryos for research.

And the last point I want to make with respect to this area is that it's also possible to use what they call cell nuclear replacement, which we think of as our traditional cloning technique, the SENT, for those purposes.

So not only can you create embryos through the research, but you can use cloning technology to create embryos for research. So the true concept of therapeutic cloning would be available for an embryo research protocol where those ends possible, but they can actually make embryos in that fashion in the U.K.

Also highly unusual. The only place I know of at this moment where you can actually do that. You may be able to do it other places where there isn't any regulation, but under a regulatory scheme.

Now, I'm really going to go very quickly over the Canadian because, as I was talking to Pat, she's really going to cover a significant amount of this material.

But the bottom line with the Canadian scheme is that there is a new act, the Assisted Human Reproduction Act, that's actually in the process of going through the various readings in the House of Commons and the senate, and it's really modeled on the HFEA Act. It sets up a licensing scheme. It sets up an overall authority. It, you know, adheres to public and private research and goes through prohibited activities and controlled activities setting out limits and restrictions, as well.

And the two things that I want to mention and that Pat will also mention is that there is a significant difference in the U.K. in that really focuses on the regulation of commercial transactions in human reproduction. That's not a focus of regulation in the U.K.., and that it includes surrogacy, not included in the U.K.

And I would also then mention from a point of legislative understanding that the guiding principles are actually imbedded in the act. They're not in the preamble, just to give you sort of a sense of what the act is about. They are part of the legislation itself.

And that, I think is quite significant. It has given them real primacy under a section called declaration of principles in Clause 2 of the act.

And then with respect to human reproductive cloning and stem cell research, neither are permitted in terms of the cloning technology, no reproductive cloning, no therapeutic cloning, but stem cell research is permitted on surplus IVF embryos. So no creation of embryos through cloning technologies, creation of embryos at all.

Germany is interesting because they are an example of what I earlier called specific legislation, specific legislation in this case being specific embryo research legislation, and they have as their over arching act the Embryo Protection Act that's been in place since 1990, and it's one of your strictest embryo research laws if not the strictest embryo research law.

IT's a criminal statute. So the focus in on criminal sanctions for violation of the act, and essentially there is no embryo research that's allowed because interventions that are not conducted for the well-being of the embryo are permitted.

So to say that in a positive way, only interventions that are conducted for the well-being of the embryo are permitted, and that necessarily means no embryo research.

All right. And it prohibits the reproductive and therapeutic cloning and the derivation of ESLs clearly not for the well-being of the embryo. Reproductive cloning also not for the well-being of the embryo.

Now, new legislation was passed on April 25th, really recently. It comes into force next week; on July 1st it actually comes into force. And this is very significant, given Germany's historical pass. We talk a lot about what happened under the Nazis and that they do not want this kind of research going forward. They're very focal and expressive about it.

And so to actually have some loosening of the embryo research area is relatively significant and reflects a lot of the scientific and public debate about embryonic stem cells.

Now, this new law will permit importation of embryonic stem cells. They looked explicitly at what President Bush put in place, and they said we can live with something like that, and it permits the importation of stem cells, only those that were produced before January 1st, 2002. So they've kind of drawn a line as well, although there has been some explicit talk in the French context about the fact that if you allow the importation of stem cells from countries that don't have a very strict system of regulation, you may be getting things in your country that you would never want in your country given how they were produced or the atmosphere in which they were produced.

So there's a real tension in the German and the French context as to whether this is, in fact, better in some respect. But this is the compromise that they've come with recently.

Now, it is, in fact, arguably stricter than the previous law, the Embryo Protection Act, the previous version, because under that act it said nothing about importation of stem cells. So this is slightly a tightening because it says you can important them, but there are very strict conditions attached to that, and only those lines produced before January 1st, 2002.

France has what they call bioethics laws, three bioethics laws that were put in place in 1994.

Now, these have been under revision since about 1999. It has taken them a significantly long time to revise these laws because of all of the changes that are coming forward because they also have a very strict embryo research background, and they're trying to loosen it, and that's quite difficult to do.

And this is interesting because what they did in France was they added relevant provisions to the criminal codes, to the civil code, to existing legislation. So it's actually relatively hard to tease out what these laws were, the changes were. And that's because in France they have a Napoleonic code where everything is in a sort of tabled code, all of the articles are in one piece of law.

So this makes France a little bit different from the common law systems where we have specific legislation and judicial precedent.

But you will see that some of the provisions have been added in the context of use of the human body, use of the human tissues of the human body, transplantation and reproduction, and a registered data act, use of information as well.

So they tend to fall in those general areas.

And the laws prohibit various activities, specify conditions for regulated activities, and are also applied to the oversight of ART, Assisted Reproductive Technology Centers.

As with Germany, interventions that are not in the interest of the embryo are not permitted. So effectively there's no embryo research that has been permitted to date, and reproductive cloning is explicitly prohibited.

Now, this act, as well, has been revised in January of this year, and it sits in sort of a political limbo right now. It's not actually in force, but with the change of governments, there was sort of an understanding that the law would be brought in by the next government in the format it's in, but with the conservative coalition coming in, they're not sure they're going to actually honor that. So it's in flux is ultimately the bottom line.

But the new, the revised bioethics laws for our purposes would permit stem cell research on surplus IVF embryos only. So no creation of embryos, and would not allow therapeutic cloning.

And they also have created — and this is a trend that obviously we're seeing — an agency which translated is the agency for procreation, for embryology, and for human genetics. It's quite a large agency, a national agency, and it would have oversight of infertility treatments, prenatal diagnostics, a specific focus in France, and embryo research.

Also a violation of the act would give rise to criminal sanctions.

Now, with respect to pulling out some of the common threads of these in the 25 minutes that I may already have run over, the guiding principles that you'll see in many of these acts, not just these four areas for regulation or countries that I've covered that have regulation including the follows:

Respect for human life and human dignity, which is something that one doesn't hear, the human dignity portion, in the United States very much, but it's a very live concept in both Canada and in Europe, and it's usually explicit as a guiding principle in this area.

Also, the quality and safety of medical treatment, particular, particular emphasis on the safety of women, usually brought out in these acts, recognizing that it's women that are really the focus of these medical interventions in the infertility context.

Protection of children's health and well-being, usually spelled out because children are obviously central in this whole equation, and their protection and their health and their well-being — and they do spell out both as different concepts, usually highlighted.

Respect for a free and informed consent. Integral to making this work, and in most countries a noncommercialization of reproduction is a guiding principle, and I'm sure Pat's going to talk about that in Canada, a really strong held principle in the Canadian act.

And of course, minimizing harm and maximizing benefit.

Common limits in embryo research now include informed consents. The more detailed they are, the more situations they cover. What do you want done if you divorce? What do you want done if you both die? What do you want done if one of you dies, et cetera?

The better the system works, the more situations that you can cover with respect to disposition of frozen embryos and gametes.

Time limits put on how long you can actually work on an embryo outside of the body, usually 14 days before the 17th day appearance of the primitive streak, et cetera.

Embryos must be necessary for a research protocol. There must not be some other way you can do your research or get this information. There must not be an appropriate animal model. It must be necessary that you use embryos for this research.

There must be protocol review, and by that I mean IRB or REB or REC, depending on what you call it, but some kind of protocol review before it comes to the authority that's licensing a particular protocol.

There needs to be regulatory oversight. So we're looking at regulatory oversight usually national if you're looking at ART legislation, and most acts include the limit of using only spare IVF embryos, those that already exist and that might be destroyed anyway rather than creating embryos, although, of course, the U.K. is quite significantly different in that respect.

Common prohibitions include reproductive cloning, the most common really prohibition. Therapeutic cloning is also commonly prohibited in a lot of these acts, not in all though as we saw in the U.K. I mentioned embryos for research. Commercialization, a common prohibition, with some flexibility as to whether you can provide payment for expenses or reasonable expenses or some payment or no payment.

Germ line intervention is routinely prohibited. This is not the case. Actually right now there has been some activity in this country with respect to germ line interventions.

Creation of hybrids or chimera, common; cross-species implantation, common; and use of fetal eggs, eggs from aborted fetuses for embryo research, not permitted.

So those ar then some of the commonalities that might be useful to pull out of these countries when you're looking at regulation in this country.

Thank you.

CHAIRMAN KASS: Thank you very much, Ms. Knowles.

Dr. Baird.

Wait. Maybe we should get the equipment set up.

DR. BAIRD: Good morning, and thank you for your invitation to be here.

It's a privilege to be presenting to such an eminent and knowledgeable group.

Now, your Chairman's letter said you were currently exploring the topics of human cloning and research involving human embryos, and he said you were interested in how in Canada we've dealt with this.

Now, our revolving policy response to these topics is not a run-off. It's not isolated, but it's integrated and imbedded in our approach to regulating the field of reprogenetic technologies as a whole.

So what I'm going to do is start by giving you a brief history of what is involved in Canada with regard to the oversight of the field of reproductive technologies. And by the time I've finished, I hope you'll have some understanding of how cloning and embryo research fits into this overall schema and how we hope to regulate other activities, such as IVF and pre-implantation genetic diagnosis.

Now, as context, I want to note that Canada and the United States have different histories, and they perhaps have more different cultures and values than you might be led to believe by our common language and our shared exposure to the same Hollywood movies and television sitcoms.

And Seymour Martin Lipsett has written a classic analysis of some of the differences in a book called Continental Divide.. He notes that the attitude to government and to regulation is different between our two countries.

Canadians' attitude, in general, is that government is there to act in the public interest. He finds Americans, in general, have a greater mistrust of government and are more likely to see it as desirable to have as little as possible.

As Lipsett puts it, one society leans towards communitarianism, the public mobilization of resources to fulfill group objectives; the other sees individualism, private endeavor as the way an unseen hand produces optimum socially beneficial results.

A principle that I think seems more prominent for Canadians is solidarity, and it's on this core concept that our publicly supported health care system rests, where individual freedom has a very prominent place in the United States.

And I think this difference in how the individual relates to the collective means that there isn't as strong a place for the market in some facets of our lives.

A second relevant part of the context is that Canada is a federated state, which makes things more interesting, but it sure makes them more complex. The United Kingdom, for example, didn't have to take into account other governments when it put the human fertilization and embryo authority into place.

In Canada, although the federal government does health research and public health education, and it transfers funding to the provinces that partially subsidizes the health care services, the provinces are responsible for health care delivery, and they have jurisdiction over hospitals and health care professions. So there's an enduring federal provincial tension, which means the federal government usually tries to insure buy-in of the provinces for significant legislation in the health field.

So with this sort of context and background, I'm going to move on to give you a brief overview of events in the evolution of policy with regard to reproductive technologies in Canada.

By the end of the 1980s, calls for public policy to deal with this area had come from many sources: legal groups, medical professional groups, women's groups, religious groups. And in Canada, we have an instrument of public policy making, which is called a Royal Commission, and such commissions are appointed by the Prime Minister, but they're independent of government. They have to stay completely arm's length, and they're giving the resources to carry out whatever work they see as necessary to fulfil their mandate, including research or wide public consultation.

And in response to all of these calls, at the end of 1989, the Prime Minister struck a Royal Commission on new reproductive technologies, and the commission was asked to recommend to the Canadian government how in Canada we should deal with reproductive technologies in the public interest.

While the commission undertook its task by consulting very widely as you can see on the overhead there, as well as public hearings, as we say in Canada, from sea to sea to sea because we have three, and hundreds of written submitted briefs, we set up toll free telephone lines because not everyone can easily come to public hearings, which over 6,000 people called.

We had surveys of randomly selected Canadians because, of course, everybody who comes to a commission voluntarily is self-selected, and we had over 15,000 individuals that way.

And we had several other ways of getting at people's opinions and allowing them to have input. And you know more than 40,000 people dealt and interacted directly with the commission before we were through.

And some of these individuals, for example, people who represented labor unions or religious organizations, actually gave us input on behalf of many other people that they had consulted. And by the time we were finished, we had had more interaction and input from the public than any other Royal Commission.

At the same time, the next overhead, we had a research and evaluation program which found out what was actually going on across the country, and we gathered data both from clinics and also from several thousand patients.

And the research program extensively examined the issues with projects and analyses in many disciplines, including the social sciences and ethics and law, as well as medicine. Over 300 researchers at some 50 institutions participated, and our budget of $30 million meant that we could have substantial interaction with the public across Canada on these issues, as well as carry out many needed research projects.

The next overhead shows that through these two streams of work, by the end of 1993, the commission was able to provide for the first time a picture of new reproductive technology uses in our country and substantial social, ethical, and legal analysis of the implications of using or of not using the technologies.

The commission made its decisions in the light of both the research findings and the broad input from the public, using explicit principles to guide the policy choices we made, and the broad ethical orientation that the commission took was an ethic of care, a stance that gives priority to the mutual care and connectedness between people and their communities, and then within that orientation, a set of eight guiding principles.

And the commission made its recommendations to government and produced, as you can see in the next overhead, a two volume final report with 15 volumes of supporting research studies, and the report sets out the science and the many issues raised, we hope, in a clear and comprehensive way, and we outlined for each policy our thinking and our reasoning for coming to the recommendations that we made.

And there's a copy on the way to your office, but it can also be obtained through that source if anybody is interested.

So in brief, what did the Royal Commission recommend? Well, it recommended that the Canadian government, as guardian of the public interest, must do two things. It must put boundaries around the use of new reproductive technologies and put in place a system to manage them within those boundaries and not just for now, but importantly, in a flexible, responsive, ongoing way. These issues are not going to go away. They are going to burgeon.

We recommended, as the next overhead shows, legislation to prohibit several aspects of the new reproductive technologies, certain kinds of human embryo research, as you can see there, using eggs from female fetuses for implantation; selling human eggs, sperm embryos, fetuses or fetal tissues; and paying for or acting as an intermediary for surrogacy arrangements.

Our analysis suggested to us that these should not be done, and there was much support across the country for these.

At the same time, as you can see on the bottom there, we strongly recommended that the Canadian government establish a national regulatory body with licensing being mandatory for the provision of new reproductive technologies to people.

We said that Canada should not continue with its present patchwork of harmful and inequitable standards and uses that we had documented when we went across the country. We found clinics and practices that ranged from exemplary to downright harmful.

There was a very strong consensus that a regulatory body was needed, and that a national approach was needed, too, because technologies have social implications that you cannot contain within the borders of one province. And allowing technology use in one province but not another would encourage reproductive tourism.

The next overhead shows the recommendation of a national regulatory body to regulate and license facilities, and that it be arm's length from government.

We recommended that women should normally make up half of the membership, and that it should be composed of people with a broad range of experiences and perspectives.

We said that members did not have to be reproductive medicine experts. They can get expert input.

We said that it was important that people who were on it shouldn't feel that they're representing particular constituencies to whom they're accountable. That's a recipe for stalemate. They should be people who wear a citizen's hat in making the judgments. They're there as parliamentarians are, to make judgments in the public, not special interest, just as this council is, I would think.

And to insure openness and transparency, we recommended that license hearings should be public, and the agency should report annually through parliament on what's occurring in Canada in uses of reproductive technology.

We saw an advantage of a regulatory body being that specific legislation didn't have to cover everything, just as Lori has said, and although the law would require a license to handle embryos and to provide services to people, the policies and the rules to be complied with to hold that license could be shaped in a way that responds to change and that continues to evolve without having to change the law.

And as I'm sure you're all very aware, this is a field where the technology is changing rapidly, and inevitably it takes many years to change legislation.

Now, the commission reported eight and a half years ago, in December '93. So what's happened since?

Next overhead, please.

Well, a year and a half later, in July 1995, the federal Minister of Health asked for a voluntary moratorium on nine items, saying that the provincial governments supported this moratorium, and that a further response was being worked on.

Now, the press across the country found this a totally inadequate response. As one editorial rather pungently put it, "In spite of a broad public consensus on the need for federal leadership, the minister's handling of this pressing issue has been disgracefully lame."

The media also that very same day quoted clinic directors who said they weren't going to abide by it.

Two different committees, as you can see, were formed to give advice to the minister on embryo research and reproductive technologies.

Then in June 1996, an act respecting new reproductive technologies, Bill C47, was introduced. This received its first and second reading, but it died on the order paper when the next year, in '97, the federal election was called.

Now, that Bill C47 was believed by many, including me, to be inappropriate because it addressed only prohibitions, very similar to the earlier call for moratorium.. It was unbalanced because it neglected the other side of the coin, which is insuring safe and beneficial technology use.

People who use these technologies to build their family need to be confident that standards of service provision, information disclosure and record keeping are being kept, and we had heard almost unanimously from all sectors that a regulatory body was needed.

So after the election, the bill died, and in spite of growing calls for a response, the federal government didn't respond, except to have extensive consultation, in particular, with the provinces through discussion documents.

Then in May last year, the federal Health Minister sent proposed legislation governing assisted reproduction to the parliamentary standing committee on health, not to the parliament; to the parliamentary standing committee on health. They were asked to examine it and report back to him.

They did so. With some changes now, the resulting legislation was put before the House of Commons early last month. It's proposed to make available the option for those provinces that wish to to put in place an equivalency agreement for other than the prohibitions. You can see how being a federated state complicates things and makes it take longer.

I sent you some background information on the legislation. This bill that's before the house has had its first and its second reading, and it's been approved in principle by a vote of 170 to 63 on May 27th.

It's now gone back to committee, and there isn't time for it to come back for a vote, the final vote, before the end of the present session tomorrow. So it's very likely to come back in the fall.

The next overhead shows the stated purposes of the legislation, which are to protect the health and safety of Canadians; to prevent commercial exploitation of reproduction; and to protect human individuality and diversity and the integrity of the human genome.

The legislation addresses clinical and ethical standards as well as the information needs of people using assisted reproduction, and the bill applies to two different purposes: the activities used to help some people have children, and the use of human embryos in research.

And written consent of gamete donors is an important feature in both areas.

The draft legislation prohibits some activities, and it makes other activities — next overhead — subject to control under regulation. And this overhead shows the activities that are regulated.

And as you can see, facilities providing infertility treatment, such as IVF or handling eggs or sperm and embryos would be regulated and be required to have a license. They would have to comply with conditions, collect specified data on outcomes, report certain medical information, et cetera, et cetera.

The act creates the Assisted Reproduction Agency of Canada to oversee all facilities doing regulated activities.

The next overhead shows the functions that that agency would have. It would be responsible for issuing and renewing licenses, collecting and analyzing health information, setting policies and monitoring compliance.

And I sent you some background describing the agency and its 13 member board.

The legislation also has some prohibitions. Next overhead. It prohibits, as Lori has said, making human embryos by nuclear transfer cloning or embryo splitting. It prohibits making embryos for research, except to improve assisted reproduction treatment procedures.

It prohibits commercial surrogacy, but permits altruistic surrogacy without payment in licensed facilities.

It prohibits identifying the sex of an embryo unless there's a medical indication and prohibits making genetic alterations to the embryo that will be passed on to future generations.

The legislation has teeth. It would prevent that it prohibited. If a prohibition has been violated, then a jail term of ten years and a half a million dollar fine is imposed.

Lesser offenses, including violation of the terms and conditions of the license have correspondingly less severe penalties.

Now, here I'd like to read you a paragraph of a presentation I made to the parliamentary committee that looked at the current legislation. I think it's much more important to get a regulatory system established than delay and delay over particular specifics.

Currently many of the people using these technologies are doing so without benefit of fully disclosed information on risks and benefit; without good data collection and record keeping, and so without reliable information on outcomes of treatment.

The important thing is that licensing of these activities will be mandatory. It will be possible to make changes when an overall system is in place.

I want now to highlight what the bill says with regard to human cloning and then with regard to research involving human embryos.

First, the wording of the prohibition in the act is that no person shall knowingly create a human clone or transplant a human clone into a human being. And a human clone is defined as an embryo that is the result of manipulation of human reproductive material or an in vitro embryo contains the same nuclear DNA as is found in the cell of a living or deceased human being, fetus, or other embryo.

And this means that reproductive cloning, as well as making human clonal embryos for research is not permitted.

The act also prohibits making an in vitro embryo for any purpose, except "creating a human being or improving or providing instruction in assisted reproduction procedures."

In other words, creating embryos specifically for other kinds of research is not permitted.

However, on the license research with human embryos that are no longer needed for treatment is permitted, provided the progenitors have given their consent in writing. Thus frozen embryos' access to treatment needs may, with consent, rather than being thawed and discarded be thawed and used in research, including stem cell research.

I think these provisions are a humane and sensible response. Making human clonal embryos for their stem cells to be used in research inevitably destroys those embryos. It creates, then destroys a human embryo which has the potential to become a person, and this reduces embryos simply to a commodity to be used.

Most people in Canada think that there's a need to respect the embryos' connections to the human community, and that it would need a very compelling reason before doing this.

It's premature to say that clonal embryos are the only possible source of stem cells. So such compelling reasons don't yet exist.

Stem cell research holds promise, but it's not likely to be the panacea that some have described, and there will be many problems inevitably to be solved. For example, fetal cell transportation was promoted as the solution to Parkinson's disease. Yet clinical research on fetal cell transplantation into the brains of affected people for well over a decade hasn't produced a reliable therapy.

Stem cell research will not come to a halt if we don't make clonal embryos. There are many research questions that need to be answered before it can honestly be said that the only way to get cures is to make clonal embryos.

And we have a provision in the legislation that it will be reviewed by a committee of parliament in three years. So there's an opportunity built in to revisit the question if the evidence, as it accumulates, starts to show that no other approach is viable.

A focused debate with broad participation across society needs to take place when the evidence is in and the field has been explored more than at present.. If by then oversight and regulation have been put in place to make sure reproductive cloning won't occur, and if the majority of the population don't then object, the prohibition could be reexamined.

My feeling is that it will not probably be necessary to.

I think we shouldn't forget that there are other ethical objections to making clonal embryos for research. To do that, you need eggs, and so women providing those eggs have to take the health risks of the hormonal treatment and the retrieval procedure.

There's also a danger of an exploited market in buying and selling human eggs developing. Women who need the money are more likely to be induced to take the health risks and do this. You don't see the well off wives of clinical directors selling their eggs.

Also, unless there's oversight and regulation in place, the existence of clonal embryos in many labs would mean sooner or later they're likely to be implanted for reproductive cloning.

Since all facilities handling human embryos in Canada will have to be licensed, whether they're public or private, all, the agency will be able to set the conditions to be complied with for a license both for research and for treatment activities.

For example, with regard to IVF, it would be able to require standards for the collection of data and for reporting of data. It would be able to require communication of written, understandable, and accurate information to potential patients.

It would be able to require standards of practice. For example, how many embryos are you allowed to implant?

And similarly, it would be able to set standards for pre-implantation diagnosis.

That can come off now.

Well, what do Canadians currently think of all of this? A recent survey of 1,700 people across the country found a very substantial majority said nuclear transfer cloning to produce humans should be outlawed. Eighty-six percent said it's acceptable to take stem cells from existing human embryos not needed for treatment. And more than 80 percent want a regulatory agency to oversee this field.

In short, a large majority of Canadians see a pressing need to put in place ethical regulation of reproductive technologies and research with human embryos. I strongly agree with them. It's long overdue.

Legal prohibitions alone are a very blunt instrument, and in this rapidly changing field a more quickly responsive regulatory body is needed.

The source of stem cells from embryos is not the only issue with regard to stem research. We also need to consider and to oversee what conjunctions of human stem cells or human nuclei with animal cells are permissible. Should human and animal cells be permitted to be put together to form a chimera?

There are commercial interests in this field with little or no oversight and a lot of financial motivation, and it shouldn't be up to an individual scientist to decide preemptively what he or she wants to do, ignoring the wishes of the rest of society and making a human by cloning or putting human pluripotent stem cells with animal embryos and developing them to see what transpires.

In conclusion, I think you can see we've come a fairly long journey in canada over the last decade, but it seems we're getting close to putting clear social policy in place, and we shouldn't forget that lack of policy is a policy. It usually means that the market will take over.

I hope that the proposed legislation is passed this year because we've been far too long in dealing with this field in spite of an ongoing public consensus that limits and oversight are needed.

Thank you.

CHAIRMAN KASS: Thank you very much.

We have half an hour or so for discussion.

Let me ask if you wouldn't mind, Mary Ann Glendon, who's been interested in international and comparative law, if she would want to at least make a comment or raise a question, and then the floor will be just generally open.

PROF. GLENDON: First, I'd like to thank Professor Knowles and Dr. Baird. I consider myself something of a connoisseur for comparative analysis, and I am very admiring of your clarity of presentation. Your remarks will be very helpful to this commission.

I thought it might be helpful if we — may I take a minute or two, Mr. Chairman?

CHAIRMAN KASS: Please.

PROF. GLENDON: Since we've been given a spectrum of approaches ranging from fairly permissive approach in England to more restrictive approaches in France and Germany; I thought that it might be helpful to situate them in the context of the two great legal traditions that are in play here, the Anglo-American common law and the Romano-Germanic civil law, with Canada a very interesting hybrid as comparative, say, or combination of the two.

And the two speakers have called attention to three relevant major differences between the civil law and the common law systems that we will have to keep in mind as part of the context for considering the approaches of France and Germany.

The first is, as Professor Knowles pointed out, the emphasis in France and Germany on human dignity, which you noted we don't find much dignity language in our legal system. We find more liberty language.

And just to underline how important your point was, dignity language is constitutional language in these legal systems. The German constitution of 1949 begins with a bill of rights rather than ending with a bill of rights, and the first article of the Germany constitution says, "The dignity of man shall be inviolable and the highest duty of the state shall be to protect it."

So there's an "ur" principle in these civil law systems, a dignitarian principle that provides an important context for the schemes of regulation in France and Germany.

The second difference comes from this word "protect" that Professor Knowles emphasized and is taken up again in the first article of the Germany constitution. The highest duty of the state to protect; the idea of a state, an affirmatively acting state with duties to protect is quite different from a principle that is deeply imbedded in the Anglo-American systems, which is a minimalist approach or, as Dr. Baird said, a more mistrustful attitude toward the state.

The third difference, this matter of commercialization. In the civil law systems, there's another deeply imbedded principle that the human body, everything related to the human body is hors de commerce, outside commerce, and so these interesting legal regulations having to do with commercialization come out of a long tradition which in the 1920s and '30s even required special statutes before people could give blood transfusions.

So that, of course, is the intention, that idea about commercialization and human bodies being outside commerce is intention with this relatively stronger emphasis on the free market in the Anglo-American systems, all of which makes Canada particularly interesting because the thinking in Canada is informed by both the kinds of attitudes that produce the legislation that we see in Great Britain, and these other attitudes about commercialization, protection, and dignity.

Now, Michael Sandel has written a book in which he points out that some of these attitudes that are strong in the civil law are also at least undercurrents or counter currents and sometimes have been quite strong in our legal system.

So I think one of the most interesting things that happened this morning is a reminder to us that there might be some ways, and perhaps you'll speak about this, Michael, in which our legal system could reappropriate or raise to the surface some of those ideas that have been undercurrents and counter currents, but that were definitely there from the founding.

And finally, I will just raise a couple of questions, one general and one specific. I think it would be very interesting and helpful for this group if either of you wanted to say some more about commodification and commercialization and the legal systems that you have presented, how it works in practice, and how it's understood and received in the populations concerned.

And the specific question, if you note, Professor Knowles, on the English commission, it's called the HFEA. It would be interesting, I think, if you could tell us a little bit about who is the chair of that commission, a little bit about the composition of that commission, how they were selected and what the background of the chair is.

Thank you.

CHAIRMAN KASS: Shall we take responses before we go down? Please, Ms. Knowles.

MS. KNOWLES: Well, I can't tell you just with respect to the second question — I can't tell you who the chair is of the commission at this moment. I don't know if Pat happens to know.

CHAIRMAN KASS: I'm sorry?

MS. KNOWLES: Do you know who it is right now? I'm not sure who it has changed to.

But I do know that the chair and deputy chair must be nonclinicians and nonscientists. That they've specified. So not only have they specified that the membership must be predominantly nonclinician, nonscientist, but the chair and the deputy chair need to also be nonclinician, nonscientist because, of course, the chair plays a fundamental role in directing discussion and bringing up questions and airing opinions. So that I do know.

They are appointed, the membership, and the membership is significantly independent. The people that I know who are on the actual authority are — the people that I know are nonscientists, in fact, have law backgrounds, and they work really hand in hand with the scientific community to understand what's going on, but also to make sure that they can enable research and treatment to go forward.

So it's quite a partnership between the authority and the clinics. It's not a partnership in the way of facilitating just anything to go on, but if the clinic doesn't meet a particular set of standards, they will work with them to highlight what they need to do to reach their standards to be able to be licensed. So it requires individuals who are willing to put in significant time commitment. They meeting monthly; they meet ten times a year. So it's a really significant time commitment, and it requires an ability to communicate across a whole context of disciplines, including the scientific disciplines as well.

Do you have anymore specific questions about the membership?

PROF. GLENDON: No.

CHAIRMAN KASS: Dr. Baird.

DR. BAIRD: The chair used to be a lawyer. I don't know if they have changed, but the British have a great and long tradition of sort of appointing the great and the good to these kinds of bodies. So that means you get anyone from bishops to actresses, all of whom are imbued with a strong sense and actually a peer group pressure, I think, to make decisions in the public interest. There is a tradition that they aren't there to act as advocates for a particular point of view, which I think is very, very helpful.

I can't make any particular comment about how our legal system differs with regard to noncommercialization because I'm not a lawyer, but another difference that immediately comes to mind is, for example, our blood system. Our blood donation is, again, completely altruistic. No money is ever accepted.

So I think there's sort of a culturally evolved way of expecting certain kinds of behavior which have contributed to the common good.

MS. KNOWLES: I can just make one comment, if I may, about commercializing modification.

CHAIRMAN KASS: Please.

MS. KNOWLES: That principle is so strongly held in continental Europe that there's a declaration, the UNESCO originally, the UNESCO declaration on human rights and the human genome in which the noncommercialization — where they actually spell out as you may not make financial profit from the human genome is an imbedded principle in that act.

And it's in the context of a — actually it's not an act. It's a treaty. It's a convention. It's actually spelled out in the context of this convention which embodies human rights and human dignity language.

So the two concepts, in my opinion, the human dignity and human rights concepts are really linked, a very strong thread through most of continental Europe, and the signatories to that act, obviously, embody that sense of nonmodification in human reproduction and human tissues in general.

CHAIRMAN KASS: Frank, to this bill? I've started a queue, but if it's —

DR. MAY: Well, I heard the word "commercialization," and what I had to say referred to that.

CHAIRMAN KASS: Well, please, why don't you follow up then?

DR. MAY: Most of the discussion of commercialization has related to the generation of knowledge and the generation of therapies. I worry about the other end of commercialization, which is access to the knowledge generated and the therapies generated in the setting of our health care system.

If one asks for the sacrifice of embryos, then one is talking about, if one really respects that sacrifice, it's a word that Michael Sandel has insisted on retaining, that word "sacrifice." Then one is talking about a kind of sacrifice that should contribute to the common good and a test of its genuine contribution to the common good is not indirectly eventually through the miracle of the marketplace system, these gifts will contribute to the raising of all boats in the water, but rather that people will have access to that knowledge and will have access to those therapies.

And that's more than simply the original problem of commercializing and exploiting women. As important as that is with regard to the production of knowledge and therapy, the other end of the distribution of that knowledge and therapy for me is a very serious issue.

CHAIRMAN KASS: Thank you.

The queue is getting sizable. Let's just go. Frank Fukuyama and then Mike Gazzaniga. We'll just go.

PROF. FUKUYAMA: Well, I want to echo Mary Ann Glendon's praise for the two speakers and those fine presentations, and I also appreciated Patricia Baird's reference to Seymour Martin Lipsett. Marty Lipsett and I taught a course, an introductory course on comparative politics for five years together and used the continental divide and also his book American Exceptionalism, which I think Americans who read that book don't understand how different their country is from other countries.

And particularly in an area like regulation, things that are fairly straightforward in Britain or Germany or France or Canada are just incredibly difficult in this country. And I suspect that if, for example, we try to establish a comparable agency to regulate reproductive assisted reproduction in this country, you'd actually get, you know, substantial opposition both from the pro choice and the pro life lobbies. I mean, they would be very suspicious of this body for entirely different reasons that both can't consistently be true simultaneously.

But it wouldn't surprise me at all if, in fact, that was the result our system produced. Nonetheless, I think that that is really the direction, you know, we ought to move in, and I would just remind all of the Council members around this table that all of these regulatory agencies, and I believe you mentioned, started with this kind of a commission.

And one of the outputs, the major output of the commission was actually a detailed recommendation for a regulatory body that would have real enforcement powers that would way outlive, you k now, the discussion group essentially that originated.

I want to get back to the question though of the memberships of both the HFEA, which perhaps Lori Knowles can speak to, and of the proposed regulatory agency in Canada because it seems to me that that's a critical issue of institutional design, is how you select the members of the board.

Now, it's interesting that, you know, there's an attempt to democratize the membership, not leaving it simply up to the scientific community or the industry itself, but you know, statutory requirement to have non-expert members.

And in thinking ahead on how this would work in the United States, how would you — I mean, what is the procedure that prevents that selection process from becoming politicized, and why is it that given, you know, the diversity of the membership on the board, let's say, of the HFEA that everybody gets along so well and, you know, they try to learn from each other and so forth?

Because I could easily imagine, you know, a similar body being established in the United States in which the selection of the individual members would be like the selection of Supreme Court Justices with, you know, the different interested communities, you know, taking a great interest in, you know, why is this person appointed?

And then if you actually do get a diversity of views, you know, having the polarizations that exit in the larger society simply being replicated, you know, within that body, but, I mean, how do you deal with that attempt to democratize the regulatory agency?

DR. FOSTER: Well, Frank, I would say that this Council has done pretty well with diverse views of talking to each other with human dignity as just one minor component of such a worry

DR. BAIRD: I think you've put your finger on the numb of something very important, and that we also struggled with in making our recommendations. It's a very complex and difficult thing to do to pick a group of citizens who are intelligent and wanting to wear a citizen's hat, not just push their own agenda.

I think to be overt about that and say that's what you're trying to do is a start because then that puts pressure on the choosers of whoever is going to be on the body.

I think it's also helpful if you make sure that there's no conflict of interest. I mean I wouldn't want to see somebody on that body making recommendations when the when they had a stake in it in some way.

I don't think there's anything wrong with having people on that body who have had nothing to do with the area before, as long as they're smart, and as long as they're trying to do the best for the society.

So that I think people who have taken strong positions in the past have a track record of really trying to push something I think I wouldn't want to see on that body.

So those are just nascent beginnings of how you would try to select people. I think if the motivation of whoever is selection is really to get an intelligent, but body that's trying to find a way through these very complex dilemmas that's going to be in the long-term public interest, I don't think there's any magic or easy way to do that.

MS. KNOWLES: I can really only add a little bit to those comments, and that is that there isn't that I'm aware of a significant component that needs to be what we refer to as lay representations. These people actually do have a track record regardless of their discipline engaging in academic or public debate of some sort.

That's interesting in and of itself because a lot of committees and authorities will actually make a spot for a lay representative and then have other people representing various voices, and that's not this model, which you've already said, Pat.

From what I understand of the HFEA, the Authority itself, the people who are chosen are chosen — some of them have quite high profile. Some of them don't, but they're chosen with a particular skill set in mind, which means that there has to be a specific knowledge of the individuals before they're chosen.

They also rotate. So they're not appointed for life. There is a rotation, like a board of directors, for example, and I believe — and I'll look it up in the break — that they sit for a term of two to three years.

They can be reappointed and often they are at that point, but there is this ability to have a rotating set of personalities and of disciplines on the Authority, which is important obviously so that you can keep the membership alive and informed and different and diverse. There isn't a polarization of positions.

And of course, your specific question about how one appoints them, I don't know the answer to that in the U.S. context. How one appoints them to make them outside of the political process is an extremely important question, and I don't know the answer to that.

CHAIRMAN KASS: Mike Gazzaniga.

DR. GAZZANIGA:: Any comparative approach is sort of Eurocentric at this point. If you were to throw in — and I Don't know if you can do this briefly — but throw in the Israel experience, the Singapore, China, India and Japan, they all look at this quite differently. Is there a way of capturing that in a brief summary?

MS. KNOWLES: I can't do that for you now. I have all of that information. I'd be glad to supplement the material that I present to you.

Israel actually has quite a long history of embryo research, of very advanced embryo research as well, and they have some recent legislation in this are.

Japan does a lot of comparative work itself before it brings in changes. I don't know of the recent Japanese situation at this point.

And there is so much new activity. For example, Australia has been going through a relatively conservative phase. They wanted to prohibit significantly embryo research and stem cell research. There was a public reaction to that and a scientific reaction to that, and they've backed slightly off of that and will likely fall closer to the Canadian position.

They also have done it in the context of a larger, quite a large volume of information on human subjects research legislation. So they've tried to work through their medical research councils and do things a little differently, and that's also right now changing.

But I'd be glad to present supplementary material to you in paper form if that's useful.

CHAIRMAN KASS: Thank you.

Michael Sandel.

PROF. SANDEL: Well, one solution to the problem Frank raises about how do you generate a committee that approaches these questions with an open minded spirit, but mutual respect would be to provide in the legislation that Chairman Kass be the czar for life of such a —

(Laughter.)

PROF. SANDEL: In here I'm just drawing on the experience that he's created here with this group. I would like to go back to the questions of modification and commercialization.

Dr. Baird pointed out, and I agree, that with cloning for biomedical research, there is the real danger of, if it's unregulated, of an exploitative market for women's eggs.

That's, of course, also true across the board with IVF, that there's a real danger, specially in this country. We see where there is no regulation of IVF, of an exploitative market for women's eggs, and you see this also in commercial surrogacy, which in the United States, except by various state court decisions, is largely unregulated.

And Bill brought to our attention, Bill Hurlbut, I think in the first meeting, that ad that's run in the Stanford paper and the Harvard student paper offering $50,000 for a woman's egg, providing the woman, the donor meets certain descriptions, including a minimum SAT score, and this has nothing to do with embryo research, this exploitative stance commodifying eggs. It has to do with the fact that we have a wholly unregulated regime with respect to IVF and commercial surrogacy.

So I don't think that embryo research is unique in this respect, but it is certainly a very serious concern for any embryo research. But I would say it's also a concern in this country that's been solved in some of the other countries, the commercialization and the exploitation that goes with that of the market for eggs, for sperm, and for embryos.

And so I would hope that we could take up, and I know we will be taking up, regulatory systems that could deal with that problem across the board, whether to do with embryo research or with IVF or with commercial surrogacy, with a few to the exploitation.

And then I think we also need to take very seriously Bill's point about what becomes of the knowledge of the stem cell lines and the therapies that may be generated from the stem cell lines. Will these become the province of companies that have patents on them and that can use them for profit, or will we take seriously the underlying principles that might lead us to support this kind of research, take seriously the underlying principle having to do with the common good, as Bill says, and provide that any stem cell lines generated have to be accessible, can't be proprietary.

And here really to know how feasible this would be, a question for Professor Knowles. Is it true that in the U.K., that all of the stem cell lines that are established have to be made available or can they be restricted?

MS. KNOWLES: I don't know the answer to that specifically.

PROF. SANDEL: The Warnock Report said that, following Bill's logic, said, as I remember, that any stem cell lines generated from embryo research had to be open and accessible. I don't know whether that was embodied in the legislation or not.

MS. KNOWLES: Actually I have the act here. I'll look it up.

It's a really interesting point that you make, and what I was going to say, I had two comments if I may in response.

The first is that with respect to the patenting question that you both brought up and access, that has been addressed in a number of the commission reports and in the Canadian commission, explicitly that there should not be patenting on a lot of these products that come from human embryos precisely for an access issue, this issue of an access to the treatments if it's going to be permitted.

So I'd be interested to know if it's embodied in the Canadian act. I'm not sure. I haven't seen that language, and I will look up the U.K. Act, and that is explicitly in some of the language in Europe. The patenting issue is addressed, and I know you're going to talk about it tomorrow.

And then the second comment I was going to make is that this issue of the — I call this issue the issue of the invisible woman, the woman who provides the oversights for the research, and she is largely invisible in the equation, but she's definitely there. They are definitely there.

And there is in this stem cell oriented legislation explicit mention of this problem, and in fact, I recall that the discussions on NBAC, they were also talking at that point about this pressure to have extra oocytes donated at the fertility clinic, extra embryos created so that they would be available for research, sine often there's research and treatment at the same time.

So explicitly in the act, there's a discussion of the need to protect women from exploitation of this sort, and I think that can't be underlined.

And the other thing that I wanted just to mention is that the Stanford ad, of course, is sort of paradigmatic in that it appeals to a particular socioeconomic group of women. And when you're talking about getting a supply of eggs for research, it's potentially a different group of women that they'll be pulling on, where they're not looking for particular phenotypic physical characteristics or SAT scores.

And I think that needs to be recognized and kept alive in the discussion.

PROF. SANDEL: In fact, could I just add a brief remark?

We do have a precedent, though we in general, as Mary Ann was pointing out, we have this kind of a Wild West of IVF, completely unregulated.

But if we were to entertain the idea of restricting, prohibiting commercialization, prohibiting sale of eggs or sperm or embryos, we would have to acknowledge — and Rebecca has raised points along these lines — we would have to acknowledge that that would come at some cost to the research. It would mean that there would be fewer eggs available.

But we make that compromise; we make that sacrifice on moral grounds to avoid exploitation in another area already, and that's organ transplants. We don't allow the purchase and sale of kidneys or the bidding of kidneys on E-bay or corneas.

And the result of that is we sacrifice the supply, and we do that on moral grounds, and I think that that is a kind of precedent that we might appeal to, those of us who would want to ban the purchase and sale and the bidding for eggs and for sperm and for embryos.

CHAIRMAN KASS: Thank you.

Let's see.

DR. ROWLEY: Can I just interject?

CHAIRMAN KASS: Please.

DR. ROWLEY: As you may well be aware, the AMA is now reconsidering that position —

CHAIRMAN KASS: As we speak.

DR. ROWLEY: — because so many individuals who need organs are dying because of the lack of the supply. So that prohibition comes at some cost, which is now being reassessed.

CHAIRMAN KASS: Thank you.

I'm going to run us over because we've got people in the queue, and this is rich. We've got a fairly porous schedule today. So we can shift the blocks of time.

Gil Meilaender and then Alfonso and, I think, Bill May was in line. Yeah, please.

PROF. MEILAENDER: Yeah, I want to return just to puzzle a little bit about the question of how to understand what these regulatory bodies do and probably risk a moment of American exceptionalism in my question, the line of questioning.

From several different angles, I'd like a little more said to help me understand why political independence or arm's length from government is so desirable since I think of as a means by which I as a citizen might have something to say about what a regulatory body did so that it didn't work in sublime independence from what I as a citizen happen to think about these questions.

So that's one angle from which I'd like to hear more, and then I admit I just do not fully understand what it means to have a kind of or, to use Frank's language, why it would be so important not to replicate the differences of opinion within society or how one has a citizen's view.

I mean, what does it mean? It doesn't mean presumably that one never thought about these matters. That wouldn't be desirable necessarily. Does it mean that one stands nowhere in particular?

I tend to think that if you think you stand nowhere, you're probably deceiving yourself, in fact, and I'd rather have someone who knows that he stands somewhere rather than someone who supposes that he doesn't. So I'm just puzzled.

Does it simply mean that you have certain kinds of civic virtues, that you're willing to listen and talk and so forth?

Well, that's perfectly compatible with holding views on the question. So what does it mean not to be interested? If it means not to have a financial interest or something, I understand that. If it means not to have a view about the moral goods that are at stake for your society, then I wouldn't know why I'd particularly want people on such a body who thought that taking a view of the common good meant excluding any vision you happened to have of what moral goods were involved.

So I admit to just puzzlement about it, and I'd welcome more clarification.

CHAIRMAN KASS: Dr. Baird, do you want to speak to this?

DR. BAIRD: It's not that, for example, the agency that we've recommended is completely inaccessible in terms of the public. I mean, they're going to be relating a great deal with the public and having public input about the policy. They also report via the Minister of Health to parliament every year with reports, and the minister himself is responsible to parliament for the actions of that agency.

So if it started to act in a very egregious fashion, there are mechanisms via parliament by which it certainly can be addressed by the polity.

I don't think either Lori or myself used language that suggested that the people who were on such a body would not be interested in any moral questions. That certainly isn't the point. You would want some people who did become engaged and who were analytic and who were trying to sort their way through the dilemmas in terms of the public interest.

And it may be that some of the people as they learn more, they're going to have extremely strong opinions, but I think one of the dangerous things is having people come from particular constituencies and feeling that they are accountable to those particular constituencies because then you come away from an argument and you either one or lost in terms of your constituency, and I think what we're trying to do here is try to reason our way through and come to compromises often on very difficult situations hopefully that will, in the long term be in the best public interest.

CHAIRMAN KASS: Thank you.

Alfonso.

PROF. GÓMEZ-LOBO: I have a question for Professor Knowles concerning two things really: the wording of some statutes and possible consequences which may have been tested by precedent or jurisprudence already, and it's this.

For instance, if I understood correctly, the U.K. act prohibits reproductive cloning, right? Now, how is that worded? What is actually prohibited? Is it the cloning itself or the implantation or what?

And then the next question is: what happens if someone violates the law? Now, of course, the person gets fined, but is the pregnancy expected to be carried to term or does the law implicitly require stopping the pregnancy?

Thank you.

MS. KNOWLES: Well, with respect to your last question, the law does not actually require termination of such a pregnancy in such a situation. That's not one of the things that it uses as its sanctions.

And now the actual act that governs that is the Human Reproductive Cloning Act, also covered, as I say, under the HFEA, the act, the actual act, and the wording that they use is they say embryos must not be created by, and they actually have a particular description of a technique, the replacement of a nucleus in a — et cetera, et cetera, which didn't cover explicitly the way that Dolly, for example, was created. So they needed to clarify that this was a type of procedure that was actually not permitted.

So that's unusual in that usually they use purposive language, purposes with respect to sort of delineating what can and cannot be done.

The sanctions that are attached to the HFEA for violation, so that if you created an embryo in this way, and it only really focuses on the use and creation of embryos; it does not focus on particular types of pregnancy, for example, or interventions in pregnancy. So that's where they actually draw a line in the act.

So they don't include surrogacy, for example. They don't include diagnostic techniques within the act, whereas some regulatory situations do.

So the sanctions are criminal sanctions, including fine and imprisonment, and imprisonment is not actually quite as hefty, nor the fines, as they are in Canada. They're a little bit shorter prison terms, but it's a violation of the act creating these things outside of the licensing scheme that gives rise to the criminal sanctions.

Does that answer your question?

Just two more, and then I think we will break. I have Bill May and Janet.

DR. MAY: I have a question about the gestation period in England and Canada from the Warnock Report to the Human Fertilisation and Embryology Act, six years in Canada from 1995, the voluntary moratorium, to 2002, the bill before parliament.

Do you think that's just the accident of these two countries that it's a six-year period and the time in history when this all happened?

Because I think about our wrestling with an issue of particular line of inquiry. Does one argue go ahead with it, with regulations, or argue for a moratorium because it will take an extended period of time to get the regulations in place?

DR. BAIRD: I think you have an inevitable delay on something as complex and value laden as this. I think you have to get policy coalitions forming and coming together to press for things. You have policy learning to go on. You need to develop regulations and really think through this.

You have to get politicians willing to actually make statements of where they stand, which is sometimes difficult. And you've got to get commitment of a political party that's in power.

So I think it's not surprising that it takes a number of years. Someone once did an evaluation of how long it took policy to be implemented after a Royal Commission, if in fact it was implemented, and on average it takes about eight years.

And I think that's because you don't have something handed to you as a Royal Commission unless it's complex and difficult to see immediately the way through and the societal institutions you already have.

I think you were into trying to change public consciousness and make space for politicians to then act. So that's why I think one of the added advantages of a Royal Commission is being able to be a little bit of a watershed in how the issues are framed and thought about in the population, which then gives space to politicians to say, "Yes, we're going to go this way. We're going to put these kinds of measures in place, and there's support by the public for it."

CHAIRMAN KASS: Janet.

DR. ROWLEY: Well, I'd like to come back to this question of the regulatory body, but from the aspect of the previous experience both in Canada and possibly U.K. and elsewhere of other regulatory bodies, and I'm thinking particularly in the United States scientists actually pressed for the establishment of a regulatory body with regard to recombinant DNA, and so we have at least that precedence within our own country.

And I wondered how Canada, for example, handled, if it did at all, recombinant DNA and technology and oversight of that, and also other countries.

And it doesn't have to be limited to that, but that's the one example I can think of in America for an example that might be applicable to this situation.

DR. BAIRD: We did have regulations put in place with regard to recombinant DNA. One comment I would have about scientific self-regulation is certainly when we went across the country and we took the public pulse, we heard time after time after time and very strongly that self-regulation may be sufficient but it's not enough — I mean, may be necessary, but it's not sufficient, because there is increasingly, I think, a recognition that the difficult decisions and the dilemmas that are facing us in these new fields are actually based on values, and that scientists are perhaps no more equipped to make those kinds of decisions for everyone; that it is only a valid process if you get input from the population.

So it was seen that a self-regulatory body would be illegitimate.

CHAIRMAN KASS: Thank you.

I think we should break. Sorry. Forgive me. I'm sorry.

MS. KNOWLES: It's not a problem at all. I just wanted to address the U.K. question, and in the context in trying to make some comparison with the U.K.

First of all, a more global issue is that the bodies, FDA, for example, which looks at some of these issues, which just recently looked to ooplasm transfer, which is definitely related in this fertility type arena. They are seen as health and safety. So their mandate specifically excludes larger ethical and societal issues.

So what is important in recognizing and looking at these agencies is they have explicit and, in fact, mandated explicitly in the Canadian act that they must address these ethical issues, and that makes what they do different from sort of scientifically based committees that look at is the research valid, you know, what's gone before, is there an animal model, a whole other range of extremely important, somewhat amorphous and difficult moral questions that must be and, in fact, are addressed in these other countries.

And I was just going to say that the professional societies, for example, usually it looks in terms of working towards regulation that there's professional societies that first adopt codes of practice, et cetera, but there is this sense that that is not enough. That has been the experience that really there are those people who live up to it and do excellent, high quality, ethical work, and there are those that just don't.

So without something more, those don't work well on its own, and with respect to the U.K. specifically, they have a companion commission, the Human Genetics Advisory Commission, which is non-legislative, which is interesting in that it's not a statutorily enabled body with criminal sanctions. It's an advisory board, and it works in areas of genetics, human genetics that are not HFEA necessarily technologies. It works in a companion and an advisory capacity, but it isn't like the HFEA.

PROF. SANDEL: Leon, a very quick clarification.

I don't understand the answer, Ms. Knowles to Professor Gómez-Lobo's question. On the human reproductive cloning prohibition, when is the crime committed? Is the crime committed when somatic cell nuclear transfer is performed with a certain intent, or is the crime committed only when there's an implantation?

MS. KNOWLES: I believe it's when — I'm not sure. I'll have to look that up.

CHAIRMAN KASS: We should break.

I want to at least raise a question which maybe we could get some answers to afterwards. I wonder whether they have organized biotech in these other countries and what role they have played in the ongoing discussions because they've played a very large role at least in our recent debates here in this country.

But that I think could be for later.

I want to thank Lori Knowles and Patricia Baird for really wonderful presentations, for opening our eyes to what's going on elsewhere and giving us a lot to think about as we proceed both with the narrow questions immediately before us, but with this larger project of what, if anything, we can suggest relevant to the United States that comes out of pondering what other countries have done.

We are ten of 11. Five after 11, 15 minutes; we'll just move everything back 15 minutes or so.

Thank you.

(Whereupon, the foregoing matter went off the record at 10:52 a.m. and went back on the record at 11:09 a.m.)


SESSION 2: HUMAN CLONING 11: PUBLIC POLICY OPTIONS

CHAIRMAN KASS: Could we start to reassemble, please?

All right. This is the Council's, believe it or not, human cloning session 11, public policy options, the first of two sessions on public policy in which with no absolutely firm boundaries between them, we want first to have a general discussion of the strengths and weaknesses of available policy options, and then especially in the afternoon gradually move toward the policy recommendations that we might put forward.

I'd like to say a little bit by way of introduction to this because I think this is a difficult and vexing subject, but a very important one, and especially in the spirit of the conversation that we've just heard, one that is in some ways more important than the cloning issue itself.

It's very hard to tell when one is in the middle of a historical situation what it really means and whether it has the kind of signal importance that some of us think it does. One would like to think not that we have the authority over this matter, but one would like to think that one would try to think about this matter in such a way that 15 or 20 years down the road one doesn't look back and say, you know, we treated something as trivial which turned out to be massively important," or conversely, we turned out to treat something which was really quite trivial as if it was of world historical significance.

I mean, I have my own hunches about this. I don't know that they're shared, but I think it's at least important to be mindful of the question that this could be something very important.

Cloning, if it works, as we have already seen, would be a new mode of human procreation, and it might also serve as a kind of precedent for selecting in advance the genetic make-up of children. So it is something in itself and something that belongs to something larger than itself.

Cloning for biomedical research, if it works, is a powerful tool for understanding and treatment of human disease, but it also is an instance of the production of new embryonic life solely for use and necessary destruction.

And if it were legislatively provided for, this would not be just permitted as it now is, but it would be officially endorsed by U.S. law. So that is something to be reckoned with.

Also, this debate about cloning is a new instance of at least some tension in the longstanding, tacit, social contract between science and technology, society and politics, on the other. It is a social contract with a moral foundation, a foundation in which scientists and researchers are encouraged to pursue the truth, but in the service of the goods of the society that contract necessarily being stressed or tested, when the things that technology and science proposed to do or want to do might come in conflict, in fact, with the values or norms of the society.

And ordinarily we, at least in this country, have allowed these things to go along without too much attention. This now comes to be a test not just about the question of cloning, but how this community will, in fact, deal with those questions when we have goods in conflict, and whether there can be democratic self-governance about these matters or whether there should be or can be democratic self-governance about these matters.

So I want to suggest to you that although it looks like a small, little question, there are lots of things just in the penumbra of this that I think are quit important.

Second, I think we've all seen why this is so hard. We have in our previous meetings taken up the questions of the ethical issues of cloning to produce children and the ethical issues of cloning for biomedical research independently of one another, and that makes perfectly good sense because the moral issues that are raised there are, indeed, quite different.

And in fact, a sign that they're different is people can be opposed to the one and be in favor of the other, and people who might be opposed to both will differ as to which they think is worse.

It might, therefore, seem sensible to disaggregate these two forms or these two uses of cloning and develop independent public policies for each, and I think if anybody has thought about this a little while sees that it's virtually impossible. It's very difficult, if not impossible, to do so.

And the reason is simple. I'm just stating the obvious, but this is to at least make it clear why we are having such a hard time. The reason is simple because both of these activities of cloning begin in the same way with the initial act of cloning by somatic cell nuclear transfer that produces the cloned embryo, and therefore, it's difficult, perhaps impossible, to craft the policy that deals with one, but does not tacitly, and usually explicitly, affect the other.

A thoroughgoing attempt to prevent cloning to produce children by banning the first step would obviously prevent cloning for biomedical research. An attempt to promote cloning by biomedical research might well have consequences for cloning to produce children. An attempt to prevent cloning to produce children at the step of the transfer of a cloned embryo to initiate a pregnancy would tacitly approve the creation of the cloned embryos for research.

And imposing penalties on implantation while sanctioning creation, a policy that banned only transfer to the uterus, would then require that the cloned embryos be destroyed at risk of federal prosecution.

So these things are, alas, mixed up together, and as the conversation has already showed, even if one tried to craft policy through statutory language, the difficulty of doing this is enormous. Let's say you wanted to make a particular act illegal. You have to precisely define what act is proscribed.

And when I first started on this subject, I thought it very simple. It shall be unlawful to attempt to clone a human being. But it's simple to say and vexing to specify.

The question that is contested is: what do you mean by a human being? Does it mean a child or adult, or does it also mean the human embryo as a human being understood at that stage of development?

And the definition of cloning is, therefore, impossible to specify unless you've specified that in advance, and attempting to clone, if you want to say, "You shall not attempt to clone," that could either mean blocking somatic cell nuclear transfer itself or the transfer of the resulting cloned embryo to a woman..

Now, there would be a way of disentangling these two things or at least having them separate if, in fact, it was done as the British, in fact, did it or as some of the other nations have done it, namely, they have a general policy on embryo research which governs everything or they have a general policy on assisted reproduction and embryo research.

And then the cloning question fits in in some way. We don't have that, and that makes our situation here, I think, terribly difficult.

Just a couple of other things and then I think we can move to the discussion. It's perfectly clear from the conversations we've had, especially on the ethics of cloning for biomedical research, that we have a clash of competing goods and interests, and it's also clear from the discussion bearing on the question is this research necessary.

This notion of necessity came up in the previous discussion, and it is important to the moral analysis. There's a dispute even on that question because we do not have full knowledge about the science so that we proceed in this discussion as almost everybody does whenever they do public policy under the veil of ignorance, sometimes more, sometimes less, but always with the kind of uncertainty about the future.

What that means is when one moves from the discussion of ethics where one could sit in one's armchair and construct one's hypotheses to the realm of policy, one really has to move from the realm of principle to the realm of prudence, which is not to say uninformed by the moral analysis, but can't simply be settled by it.

And this means really thinking about the ends that we're seeking, thinking about selecting the fitting means always in the light of the circumstances, a very complicated task always, and especially when the best simply might be different from the best possible here and now. That might be the situation in which we find ourselves.

And I would at least like to suggest that the ethical analysis that we've been engaged in is certainly pertinent here, but it has now to consider all kinds of other things that are related to the complexity of what happens if you actually try to give voice to your ethical intuitions at the level of public policy, given the difficulties of drafting, given the competing goods and the like.

There is a question, I think, that will lurk beneath the surface of this discussion, which is who bears the burden of proof and persuasion in these kinds of matters. Is it the proponents who are proposing that we cross certain kinds of moral boundaries or is it the people who want to say no, when in a country, by and large, freedom is the rule? You have to do more than sort of say certain kinds of things might happen, but you have to show that they might likely happen and the costs to the common good are sufficiently great before you restrict people and even put them in jail.

I mean, these are important things, I think, to keep in mind.

Let me just introduce the specific proposals that we can consider. Then I would open the discussion either on the general matters and then gradually move to — I'll go wherever you'd like, but we have, if you think about it, one has, thinking now just about human cloning, and we've got, let's say, Cloning 1 and Cloning 2. I mean cloning to produce children and cloning for biomedical research.

There are two large categories, allow and forbid, and under each category, there are two possibilities: allow without regulation or allow with regulation; forbid for now, forbid permanently.

Anybody who likes matrices knows that you could make a four-by-four matrix, and you'd get 16 possibilities. If you did it for yourself, you'd see that there's a whole bunch of them that simply are not sensical, namely, that you would forbid cloning for biomedical research and endorse without regulation cloning for baby making.

So I think that the option that sort of survive as even things to be thought about are on a sheet that you should have in front of you. I'll simply read them off, and I think part of what we want to do is discuss the strengths and weaknesses of these.

One would be, in effect, the position that says allow with no regulation; no legislative action; professional self-regulation.

Second would be a ban on a cloning to produce children, but with no regulation, neither endorsement nor restriction of cloning for biomedical research, what we're calling ban plus silence on the research.

Very hard to do, by the way, to write that legislation so that it's simply silent, but never mind.

Possibility three, ban on cloning to produce children with regulation, permission but under regulation of the use of cloned human embryos for biomedical research. Option three called ban plus regulation.

Option four, regulation across the board, no restriction — no — in other words, permit but with regulation, something like the British agency where there's permission, but all permission must be given under the rules set by the Human Fertilisation and Embryological Authority.

Possibility five would be the most restrictive one: a ban on all human cloning, whether to produce children or for biomedical research. Shorthand: ban on both.

Then two proposals that consider the possibility of a temporary ban pending further information or additional public debate.

Option six, a ban on cloning to produce children with a moratorium, a moratorium being understood to be a temporary ban, a ban, but with a fixed time period on cloning for biomedical research. Option six, ban plus moratorium.

And option seven, a moratorium on all human cloning, whether to produce children or for biomedical research. Shorthand name, moratorium on both.

If somebody has something else, another plausible suggestion to add to this, this is enough, but if we've left something out, by all means, feel free. And since this is a general discussion and this is simply the fruit of the staff's analysis with my own input, we might not have done this right, but at least this is what we put before you for consideration both in general terms and with different options with their various strengths and weaknesses.

If there were a perfect solution for this, we wouldn't be sitting around here talking.

The floor is open. Frank.

PROF. FUKUYAMA: Well, not to complicate your matrix unduly, but I do think there is another option that would be my preferred option. That would actually be a combination of number six and number there. That is to say you have a ban plus a moratorium, but the explicit justification for the moratorium is that you need the time to put into place a regulatory, you know, apparatus as we've seen, you know, take six year or eight years even under favorable circumstances to do this.

And so, you know, the regulatory option is not a short-term option. So I would think that some, you know, combination of six and three is actually a logical —

CHAIRMAN KASS: You mean six for the sake of three.

PROF. FUKUYAMA: Yeah, right.

CHAIRMAN KASS: Janet?

DR. ROWLEY: Well, let me first just comment on Frank's last comment. I believe the six years is not due to the difficulty of putting in a regulatory apparatus, but rather just getting legislation through. So that I think it's important to separate the legislative process from the regulatory. At least that would be my interpretation.

And I have to say in reading the material that we were sent, I was concerned — that we were sent earlier — I was concerned on page 6 of the chapter we're currently considering that the burden of persuasion belongs to the proponents of human cloning.

And I have to say since it is something that is currently unregulated, though there certainly are prohibitions on the funding of aspects of cloning, that I wonder why the burden of persuasion is on the proponents rather than those who want to change the present situation.

CHAIRMAN KASS: Does someone want to join that?

Where —

DR. ROWLEY: Page 6, Line 18.

I mean, I think it's not our problem. Well, I think that the burden of proof is on those who say that what is — and I don't want to push this too far because there are certainly aspects that I would not be in favor of — but at least in the private sector, the laissez-faire attitude that is currently in place in the United States is a practice of at least those who can get private funding.

And it isn't only from companies because the Howard Hughes is also providing funding for some development of embryos for research; that the burden of proof ought to be on those who think that this practice should be stopped rather than on those who say that some component or some facets of the present situation — that we have to justify that component of the present situation.

And I would just turn it around and say I think the burden of proof is on those who say that components of the present situation should be banned.

CHAIRMAN KASS: Yeah. I really raised that as a general question in my opening remarks, and it really is part of how you come at this question.

I mean, basically we think in this country that you're free to do things until and unless there are powerful public reasons of a serious harm to a public good that keeps you from doing it.

DR. ROWLEY: That's right, but this document says that, in fact, the burden of proof was —

CHAIRMAN KASS: It was a question on moral persuasion as opposed to — if you follow the second point, I think you'd see it on that same page, but could we take up the question apart from the document? Because we really want to talk about the issues and not about text at this point.

And Janet, I think, has raised the right question. Gil, do you want to speak to that question?

PROF. MEILAENDER: Yeah, just a very brief comment to it. Although it's right, as you said, that we in our society have as a sort of general practice that we leave you free unless there seems to be good reason not to, I think it would be a mistake to suppose that there's been some kind of longstanding freedom to do research cloning, which now all of a sudden we need to think about whether there's justification to prohibit or regulate.

It hasn't, in fact, been done for very long or there haven't been good reasons, promising reasons to do it.

So it's not as if there's some sort of longstanding practice that opponents are suddenly thinking of stopping, and that makes a little bit of a difference.

CHAIRMAN KASS: Yeah, and the other thing that while it's not legislation, I mean, the various states can do as they wish, but I remind everybody that our predecessor body, the National Bioethics Advisory Commission didn't deal, I think, with cloning for biomedical research, but did in its embryo research paper make a distinction between — and this is not legislation — but made a distinction between the use of embryos left over in in vitro clinic and the creation of embryos solely for research.

Whatever the moral weight of the distinction is, and we've had some interesting discussions about whether that's a distinction that can be upheld, that has at least been the normative precedent of the climate.

Now, there are new developments that always challenge those things, and that's where we are, and Janet's question stands.

Michael, did you want to say something?

PROF. SANDEL: Just this briefly. The concept of burden of proof is a legal concept in convicting of criminals, and I think when we try to transport it into burden of moral argument, I think it doesn't help us.

Nobody who holds one or another position is going to say, "Well, the burden of argument is on me."

Everyone is going to say, "Well, no, it's on the other side." Well, if that's the case, let's just get to the arguments. I don't think anything is going to be helped by haggling over who has the burden of making a better argument.

CHAIRMAN KASS: Okay. After Rebecca speaks, I'll let you get to the argument, I mean, if you'd like.

I mean, if people want to weigh in on some of these general things, fine, but if that's where people would like to go, we should go there soon.

Rebecca, please.

PROF. DRESSER: Well, maybe I'm getting to the argument. I think implicit in that view — and, you know, there is a burden in civil proceedings as well that it would be based on this special respect position, that is, that a human embryo is not a piece of property or a person. It's something in between. It's owed some respect. So if we're going to create it, whether through cloning or some other procedure to be used in research, there should be extremely good reasons.

And that's where the burden of proof would be, to show that those reasons exist.

CHAIRMAN KASS: Does someone want to put their toe in the water and talk about the strengths and weaknesses of the various options before us or —Michael, please, and then Elizabeth.

DR. GAZZANIGA:: For those of you who are on the committee who are more familiar with policy, I think of it as sausage, but know all of the subtleties of —

CHAIRMAN KASS: The work for prudence statesman, Michael.

(Laughter.)

DR. GAZZANIGA:: Could someone discuss if there's a definitional reality to the difference between guidelines versus regulations in "governmentese"?

Because the current recombinant DNA model is really a set of guidelines, as I understand them, and not really a set of regulations, and I'm sure that's a determinological question we should get established here as to what we mean?

CHAIRMAN KASS: Someone want to take that? Rebecca, do you want to get in the — please.

DR. BLACKBURN: So my brief re-review of the recombinant DNA guidelines done on the Internet last night, I have to confess, was that it is applying to institutions that get any kind of NIH money, even though it's nothing to do with necessarily the project that is being considered.

And as far as I could tell, the force of it was the ability to get or not get NIH funding. And what the noncompliance consequences were, I am not familiar with, and maybe you can if somebody knows that.

It's meant to be a deterrent against violating those guidelines, but I don't know what forced the deterrence against violating, what form that took..

DR. ROWLEY: Well, I can answer that. You lost your NIH funding, and I believe you could not apply for new funding for a period of time, whether it was three years or five years, but for those dependent on NIH funding, it was a pretty serious consequence, though not criminal.

CHAIRMAN KASS: Well, I think we still need more on the general point, right? That is —

PROF. MEILAENDER: Well, what's at the bottom, I think most of us — I guess we're all sort of publicly split on the question of the ethics of biomedical cloning, half of us for it and so forth.

The recombinant DNA story had at the time a public fear associated with it that there was going to be something oozing out of laboratories that was going to transform the biological world. And in this particular context that we're being asked to think, there's no real biologic risk involved. The notion of regulation is for social concern for people's values and views. There's nothing at risk in terms of risk to the general culture in terms of health.

And so I think, therefore —

CHAIRMAN KASS: The women egg donors is certainly one of the issues that would —

DR. GAZZANIGA:: But that aside, I mean, the actual cloning procedure itself and so forth.

CHAIRMAN KASS: Right.

DR. GAZZANIGA:: So this is just why the question of regulation — we actually just mean regulation here in terms of almost satisfying social concerns and people's moral concerns and not because there's a biologic risk involved, too, as a result of the laboratory act itself.

CHAIRMAN KASS: I think that's largely right here, and as we heard in the previous presentations, I mean, among the things that are subject to regulation, I mean, guidelines might include things like the steps of licensure and what you have to do to remain in compliance where as regulations might include things that are just out of bounds or there might be regulation of commerce.

There is a regulation which says composated surrogacy is illegal. You know, uncompensated is permitted. Those are regulations, and if I understood at least the presentation of the Canadian system there, there are penalties that are attached to that

Alfonso and then Frank and Rebecca, I guess.

PROF. GÓMEZ-LOBO: Can I address that briefly? I think that when I think about reproductive cloning, I think the reason why regulation is needed and perhaps even something like a criminal statute is because, on the one hand, we know that certain actions can produce tremendous harm here to the women donating the eggs, to the woman doing through the pregnancy, and to the child himself or herself.

So it's not just because of any sort of vague social concerns. I mean, we're here talking about very central goods that hopefully our society will protect.

DR. GAZZANIGA:: I was thinking only about the biomedical cloning obviously, not the reproductive cloning.

CHAIRMAN KASS: Okay. I have Frank, Rebecca, Janet — no. Your name is on the list, and I don't know whether it was for the last time. Okay. Thank you.

Frank, and then Rebecca.

PROF. FUKUYAMA: Okay. So is it —

CHAIRMAN KASS: And then Robby.

PROF. FUKUYAMA: — appropriate to jump back into the substantive?

CHAIRMAN KASS: The floor is yours, sir.

PROF. FUKUYAMA: Well, I guess what I'd like to do is just lay out my position of how I proceed from my basic ethical position to the actual public policy because, as I just said, I'm in favor of six leading to three, and I would do it for the following reasons.

I put myself in the camp of special moral status, that is to say I do not believe that an embryo has the same moral status as an infant. I believe moral status rises. I mean, I'll just — in addition to the text that we were given, I thought it gave a fairly good defense of that position.

I would just add a couple of examples because I know Alfonso contested the idea that you could have a coherent doctrine of rising moral status.

But I think that, you know, in fact, we attribute that to human beings all the time. For example, children have a different moral status than adults. Children are not given political rights. They can't vote because they don't have full human reason, and you know, political rights are, you know — it's not the right to life, but it is an important component of, you know, the class of individuals to whom we attribute.

Now, I would just like to say I don't want to start a big argument over this. I'm just trying to state my position.

DR. MCHUGH: Oh, why don't you open that door?

(Laughter.)

CHAIRMAN KASS: The record notes that that's not a universal opinion in this room.

PROF. FUKUYAMA: And, you know, I know we could argue for the rest of this session over that. I'm just telling you what my view is.

However, I believe that, you know, there is some moral status that is, you know — that differentiates an embryo from just another clump of cells, and I will give you another analogy for another group of — a case similar to this, which is bodies of dead people.

We attribute a special moral status to those. If your Uncle Eddie dies in your living room, you can't just dump the body into a dumpster. You have to take a lot of — it's a highly regulated, you know, set of actions that happens when somebody dies because we believe that even though this was not a moral agent, you know, that that deceased corpse is, you know, due a certain amount of respect that is different from other kinds of tissues or different from a dead animal body, and so forth.

And it can be used for experimental purposes, you know, medical schools and so forth. And so we regulate it very carefully.

Now, my particular fear is about research cloning, not with the procedure itself, I would have to say, but more with precedence and slippery slopes and other things that may proceed if we simply permit it in a completely unregulated way.

Again, a lot of this was articulated in the report, but for example, I would not want in three or four years' time for the medical research community to come back and say, "Yes, in fact, we do need to get not just stem cells out of embryos. We need to get entire organs or fetal eggs or tissues out of fetuses. And, by the way, we should be able to do that because, you know, what's the difference? We already extract stem cells from embryos. So why not go about this?"

And the same arguments will be trotted out that we're going to save X number of lives, cure X number of diseases if only we can do that.

And I believe that, you know, there is an important role difference between an embryo and a fetus, and I definitely would not like to see the latter thing happen, and I don't want the precedent of research cloning on embryos to be used as a precedent for allowing other things further down the line, human animal hybrids.

You know, I mean, there are a lot of things that are bad in the other legislation in Canada and the U.K. that are example so categories of things that are not issues right now, but where we could get to based on precedents that we set in our policy towards research cloning.

Therefore, I believe that the appropriate solution is to permit it under a strict set of guidelines that would involve no research past, you know, 14 days. I mean some — you've got to pick some fairly arbitrary number, and you know, I think actually the outlines of the kinds of regulations; we could argue about this or that specific provision, but a lot of those have been laid out in the legislation that exists in other countries.

And I think that under those circumstances most of my, in a way, prudential fears about permitting this kind f research to go ahead would be satisfied.

And that's why I think that, in fact, the optimal solution from my standpoint would be the regulatory option rather than the complete ban.

Now, again, I'm hoping to short circuit a big argument over moral status because I just don't think we're ever going to convince each other. I would just say, you know, to those that want the complete ban that it looks like, given the realities of politics in the senate right now, that we're simply not going to have option five, the ban on both. Okay?

So then the position defaults to option one, which is essentially no ban on anything, and I guess what I would just ask you to do is to consider seriously, you know, in the real world of politics whether no ban on anything is better than, you know, my proposed solution, which would be a ban on the things that we can agree on banning, which is reproductive cloning, and then a moratorium leading to a series of rules that would satisfy, you know, I think a lot of the precedential and desensitization kinds of issues that I think are very real ones in permitting research cloning to go ahead.

CHAIRMAN KASS: Could I make a procedural suggestion? We've tried and, I think, pretty much succeeded even as this debate swirls around us to keep an eye on it, but to have our own discussions here, and it's true that when one makes prudential recommendations, one would be foolish not to notice what's going on around us, but at least at the first pass I think we should talk about what we think would be best were it up to us.

And one could then make some adjustments. Frank's point is well taken, but I would rather we not immediately sort of start guessing what might work, what might work in the Senate if they were to listen to us. They're unlikely to in any case. We should try to figure out — we should try to recommend what we think is the right thing to do.

Let's see. I've got a queue, and I hope everybody will get into it. Let's see. I've got Rebecca, Robby, Michael, Elizabeth, Mary Ann.

PROF. DRESSER: I agree with Frank that there are a lot of similarities between three and six, ban plus moratorium and ban plus regulation. I think three is really a de facto moratorium, and of course, the difference is that it would be de facto moratorium getting the planning going, the system going.

And in connection with three, I wonder if when we say "regulation," that there are a number of principles, I think, as we've heard, and certainly I can think of a number of other principles that a regulatory system could have in place if, you know, it were regulating biomedical research cloning.

So I wonder if it would be worthwhile discussing more substance and procedures. I think we had an interesting discussion this morning about who should participate in this regulatory body. I personally very much am in favor of a large component of people who are not from a scientific or medical background being involved in making judgments about when a proposal to clone research embryos might be justified.

And I would also want to include not just — even though this is against my self-interest, I suppose, it seems so often when people say there should be public members, lawyers end up being the public members, and it sounds as though in the U.K. that's frequently true.

I do think that there is an important place for ordinary people. I think that this problem of trying to get people who do not represent one interest group, but yet are thoughtful, involved, and interested in moral questions and not just ciphers is a challenging one, but I really think it's one worth pursuing.

So perhaps we might talk about if there were to be a regulatory structure how it would work and what specific principles different people might favor.

And then I just thought I'd throw this out. This is probably off the wall, but I thought of it this morning. One concern I know that some people have with biomedical research cloning is that it would, if it were permitted, it would put the government in the position of requiring the destruction of human embryos.

And I wondered if anyone would feel any differently if there were a no freezing rule or a no preservation rule in research so that in some respects you could say the embryos are allowed to die rather than actively destroyed.

And then, on the other hand, what kind of a scientific impact would that have I you weren't able to freeze the embryos in research?

I thought of that on the exercise bike this morning, and I thought I'd throw it out.

CHAIRMAN KASS: Michael Sandel.

PROF. SANDEL: Well, though I share much of the spirit and even much of the substance of Frank's position, I have just a small qualification that I would add and suggest, and perhaps he wouldn't object to this first.

I don't think, as someone who holds a position close to the one on the substance that Frank has articulated, I don't think that we should urge colleagues or fellow citizens who hold the equal moral status view to support a moratorium instead of a ban for the following reason.

A moratorium, as Leon pointed out, might be justified if you say that you need further information about the science or about whether the science is really necessary.

But if you hold the view that ethically, regardless of the benefits, ethically it's wrong, it's like killing a baby for a good end; it's wrong to extract stem cells and to destroy the embryo; then a moratorium which says, well, we need more information doesn't really capture that position.

A moratorium, after all, presupposes that the practice is not ethically impermissible, but we need to really find out about the science if it's necessary. Will the therapies work? Are there other ways of doing it scientifically?

But to accept a moratorium rather than a ban presupposes that maybe some time down the road this would be morally permissible, and otherwise, the principal position is a ban.

So I don't think that we should say, "Look. Your view isn't going to prevail in the Senate," and who knows whether that's true or not. Even if it were true, I don't think we should be in the position of trying to persuade colleagues who hold the equal moral status view in good conscience to say, "Don't support a ban. Support a moratorium," because the moratorium doesn't capture that moral position.

It sends to the public and to ourselves and to the President a different message. It says this is not fundamentally wrong for all time. That's why we want to have an open mind. That's why we want to see how the science unfolds.

Having said that, I would just want to pick up on a point that Rebecca just made for the view that those who don't hold the equal moral status view, but who hold some — but who would still accord respect to the embryo, I think Rebecca had a slightly different way of addressing Frank's concern.

Position three Rebecca just said, and I was struck by this, is a de facto moratorium because position three says it's not morally impermissible for all time, but we don't want commodification; we don't want exploitation. We want to establish a limit, whether it's 14 days or others. We want to license and conduct prior review of all research involving cloned embryos.

Well, if the regulations even in general terms are specified along those lines, then position three, ban plus regulation, could say under the regulatory half of it that only instances of cloning for biomedical research shall be permitted that observe these various restrictions, no buying and selling, no modification, and so on, and that are licensed by some authority or border commission yet to be established.

And if you established, Frank, as one of the regulations the licensing requirement, then by definition it couldn't go forward until that board or that authority were in place.

So that's why I think your concerns, which I share, could be perfectly well met within the compass of number three, drawing upon Rebecca's suggestion and listing among the regulations the licensing requirement, which wouldn't exist, and therefore, the permission couldn't be given until that board and those regulations were already established and existing.

CHAIRMAN KASS: Elizabeth.

DR. BLACKBURN: I'd like to continue to draw on this question of the moratorium, de facto or otherwise, and in thinking about a moratorium as had been proposed in number six, but I'm certainly listening to what's being said about number three with respect to it being de facto moratorium — I see a lot of force in that — I just do want to raise some points about a moratorium.

It sounds tempting to have a moratorium to get more information, but I really am trying to think hard what is the information that one is going to get if the very kind of information we want to get about promise of the possible benefits of the research is not going to be allowed to take place?

So then the question is: well, could you get that information from other kinds of research?

So I thought hard about this. Can you get that? And I really think you can't get that kind of information, and let me just give you a few examples of it.

Say, for example, with current, let's say, excess in vitro fertilization embryos, what you would get would be some set of embryos, but the kind of information you'd need about them, the ability to have disease models, the ability to have certain genetic diversity that you knew something about at least, you just wouldn't have that. And so you would really hobble the information you would get out.

And then, secondly, if one were thinking about somatic cell nuclear transfer derived embryos, what can they give you besides excess in vitro fertilized embryos?

And I thought very hard, well, you know, what do they give you and is it substantive, and again, I think it is substantive, first, for those reasons I just said, and secondly, that you can do things in terms of finding out some of the key issues about the therapeutic value of cloning for biomedical research derived embryos.

For example, what would be the immune rejection issue? There are a lot of really good in vitro type of examinations one could do to get at this question that you couldn't do otherwise with animal systems, for example, and animal models have been the only source of information on this topic to date, and we know that animal models are not valid models in a lot of biological questions that we have about humans.

And I can, you know, cite various disease sorts of cases and things that are relevant for cancer in the mouse versus the human. They are very different. They play out differently.

So I do want to say that the problem then is that if one said, "Well, let's have a moratorium and wait for more information that will give us a better informed set of facts on which we could move ahead," we won't get those facts unless the information can be got from the somatic cell nuclear derived embryos.

I just can't see how the information — so then there's a real inconsistency because, you know, some members of the Council, you know, have concerns about the ethical problems with cloning for biomedical research based on embryo status, but it seems like from our deliberations, you know, probably a good half of us don't have ethical problems with this.

And so we all have said this is important enough to move ahead with, and so then if it's important enough to move ahead with, then we don't want to just hobble the ability to do it properly.

So my feeling is the moratorium then was a real concern to me because it seemed to me actually counterproductive to what we are thinking of as the possible good that would come out of this. And so I think back then to what I think Rebecca said, which is sort of returning to the point of in effect, if one does have appropriate licensing for regulation — licensing which would include, you know — be included in the regulation, then in a way that does take care of it.

I think imposing a moratorium per se does not achieve anything, and I think it's actually counterproductive for what we feel might be the good coming out of the proceeding forward.

CHAIRMAN KASS: Elizabeth, could I ask you just directly on the science?

DR. BLACKBURN: Yes.

CHAIRMAN KASS: Granted that eventually if this is to be shown to be useful in human beings, it could only be done by experimentation with human beings, but —

DR. BLACKBURN: Oh, Leon, before that, there's much in vitro work that could be done before —

CHAIRMAN KASS: I'm not talking about therapy. I'm talking about —

DR. BLACKBURN: Okay. Sorry.

CHAIRMAN KASS: — I'm talking about —

DR. BLACKBURN: You mean only on cloned embryos.

CHAIRMAN KASS: Yes. I'm sorry.

DR. BLACKBURN: Stem cells derived from cloned embryos, yes.

CHAIRMAN KASS: Ordinary stem cells are not in the discussion here. I mean stem cells derived from in vitro — adult and embryonic stem cells derived from sexually fertilized embryos are not part of this discussion. Just on the question of work with embryos produced by somatic cell nuclear transfer.

DR. BLACKBURN: Right, right.

CHAIRMAN KASS: Right. For the most part, we've had proposals about how this work could be useful both in terms of deriving basic knowledge and possibly therapeutic benefit. I think it's fair to say that there's very little evidence available to us now in the science as to whether that promise will be realized or not.

Would it not be relevant to see whether some of that work could be done in animals to the point of actually encouraging us to believe that the human work would work?

And wouldn't it — second point, there's a claim that there is a unique benefit to be had from working with cloned human embryos and tissues derived therefrom, but since part of the question has to do with the necessity and whether there are other morally nonproblematic alternatives be taken up before certain boundaries are crossed, what if it should turn out that the work that we heard about last time from Dr. Verfaillie, which by the way I think is about to be published today or tomorrow in Nature?

One would get the variety of stem cells from the whole plethora of disease models. One would be able to study the differentiation. Wouldn't there be some burden before one sort of crosses this line to actually say — we really have some evidence to say not only that this stuff will work and will be promising. We've done work in animals, but also that we don't have other morally nonproblematic alternatives.

Is that part of the way we think about the necessity of doing this as opposed to it's interesting, very useful?

DR. BLACKBURN: I think of course alternative methods and all avenues, I think, are important to explore in getting the kind of basic understanding which will then be very important for getting usefully therapeutic information, you know, be it of the tissue generative type or other kinds of broader information.

So let me take your points perhaps in reverse order. The question of what will adult stem cells and their reported plasticity give us, we won't know that from the publication tomorrow.

CHAIRMAN KASS: No, that's for sure.

DR. BLACKBURN: It's very controversial, and there are many different interpretations out there in the field.

I just recently attended a workshop on this to get myself well informed on this. We're not going to know about adult stem cells being the one and only way to do this, and Catherine herself has certainly —

CHAIRMAN KASS: I didn't say one and only, I think.

DR. BLACKBURN: No, no. And she herself pointed out the value of keeping the avenues open because we don't know which will be best. So certainly adult stem cell research, I think everyone agrees, should certainly be pursued vigorously for what it could be useful for, but it's not going to be the only thing, and it will not answer for us whether it's the only possible source of —

CHAIRMAN KASS: But let me —

DR. BLACKBURN: — the information we can get out.

CHAIRMAN KASS: But let me persist on this because the question — on the issue of the moratorium, I mean, one of the arguments for a moratorium would be right now we have mostly — and I'll exaggerate — right now we have mostly promise and virtually no evidence.

DR. BLACKBURN: Well, except in animal models.

CHAIRMAN KASS: With respect to the cloning, with respect to the cloning.

A moratorium would, in fact, perhaps answer this question about the unique value of this. It might or it might not, but it's not — that is at least — if the question is — sorry. Let me put this — and, by the way, I'm not plumping for a particular outcome.

I think just as the side that says you shouldn't go forward because there might be harms has to do more than speculate about the harms, but show that they're likely and that they're serious, so it seems to me that the side that says there has to be benefits has to do more than wave the flag.

And also if you're crossing a moral boundary, then it seems to me something of the burden of the uniqueness or the necessity of this. And if we don't have the evidence of the necessity, that it seems to me is also part of the moral deliberation.

It doesn't settle the matter. There are some people who say this research should never be done, but I'm basically asking the scientists in the group to not simply say, "Well, we won't know." But does it count? And could we find out?

At the moment we don't have the animal research, and we haven't really tried the other alternative. What would be so terrible about saying take four or five years and find out what the alternative is?

That would be my question.

DR. BLACKBURN: Well, I think that you would be so hobbling the investigation as to make it — you see, you're saying let's use apples to learn about oranges, and that's the issue, oranges being the cloned somatic cell nuclear transfer derived organisms.. Because they really can provide a very different set of stem cells in which you can do experiments that you wouldn't be able to do with the in vitro fertilized excess embryo route, for example, because of the kinds of disease models and genetic variability you can get.

You really cannot get that from what we have in hand. The second issue then is animal models. Of course, you know, everyone wants to use as much as possible the animal models, and there's no doubt that they have provided some evidence as we heard from John Gearhart, that there's some interesting and very interesting, you know, provocative and I'd say promising — I know you're devaluing the word "promising" — but promising therapeutic proof of principle demonstrations that have gone on in animal models.

CHAIRMAN KASS: They were rejected in that animal.

DR. BLACKBURN: Sorry. What was rejected?

CHAIRMAN KASS: I'm sorry. Let me just desist. Sorry.

DR. BLACKBURN: So this is not in any way to say that animal modeled research is not valuable, but in the end it doesn't tell us about certain things about human diseases.

Just take my own field, if you want me to get very substantial. The role of telomese (phonetic) and telomerase in development of cancer in a mouse plays a very different course out than it plays in humans. We do not learn the same things, even though the list of actors is the same.

The thing that they play out is really different, and in the mouse it didn't tell you what was important in the human.

So it's just one very tiny example. So I think scientifically we just won't learn what we would learn if — when I say "we," I mean the community is large. I don't do this research — but one wouldn't learn the same kinds of things.

So that's why I'm thinking the moratorium imposed per se actually — you know, it actually prevents the very purpose that it's supposedly to produce.

CHAIRMAN KASS: Janet, to this?

DR. ROWLEY: I'd like to make several points, one of which is for most of the biomedical community that depends on NIH for support, there is already a moratorium, and there has been a moratorium for years on funding any sort of research on embryos, embryonic stem cells, et cetera.

So that is the present situation. If you go to private organizations or you go to companies, it's different, but for the vast majority of scientists, we are already in a time of moratorium.

Just as an aside, I haven't seen Catherine's paper in Nature, but at least up until a couple of months ago, her adult stem cells ironically derived from bone marrow could not produce hematopoietic stem cells.

So they can be transformed into everything else, except hematopoietic stem cells, and this just shows a limitation of that particular system.

And the more substantive point is that as I would envision a regulatory body, and again, one that we all hope will be constituted of the very thoughtful individuals, the proposed research on embryos would come before such a body for scientific, as well as ethical review.

The scientific review should be very — should look very carefully at what is the proposal from the particular investigator. What is the unique role that that research plays? And why is the use of somatic cell nuclear transfer into oocytes derived from volunteers or whatever source? Why is that the only way to do this research?

So I think in a thoughtful pattern of regulation you would already have answered the questions that you're raising.

And I agree with Elizabeth. We are already in a moratorium. Extending the moratorium only impedes scientists who would like to get at transferring or transforming a promise into some reality at least in certain circumstances.

So that I think that the thoughtful development of a regulatory body is really a critical aspect of this. I was taken by the comments that Lori made in her presentation to us about the U.K. That legislation, as I understand, and I may be misquoting you and you can speak for yourself obviously and educate me and others, is for the most part relatively general, though obviously the newest one preventing or banning reproductive cloning is fairly specific, but the legislation is fairly general, and it is, I gather, assumed that this regulatory body will be the one that will over time review the situation, modify the regulations based on an evolving set of knowledge and make regulations at the time that are appropriate for that evolving set of knowledge.

And the other thing you said was that there are working groups of five individuals, I believe, and much of these or at least some of the specific details go to those working groups for their evaluation as long as they're not policy issues maybe before they go to the larger group of individuals.

And I would envision, as well, that in institutions that already have institutional review boards for looking at matters that deal with human tissue, any research that I do in my laboratory on patient material is already reviewed and approved by our institutional review board before it goes to anyone for any consideration or funding.

I think with all of those levels of review and consideration that one of the important issues here is more how to develop a regulatory body, and I don't think that we need to consider a moratorium as one of the options.

Did I misspeak?

MS. KNOWLES: The only thing that I would correct is that it's actually not the authority that makes the regulations. The regulations are made through the parliamentary process, regulations to the act. So adding more to the act through regulations is quite a cumbersome and official process.

But they framed the act generally so that the licensing body, the HFEA, has significant discretion in its licensing functions so that they go through a number of steps and really get a lot of information,a nd that's where the discretion is.

CHAIRMAN KASS: I have Mary Ann next.

PROF. GLENDON: So far in this discussion only two reasons have been mentioned as justifications for the moratorium. One is the time necessary to prepare regulations, which as Rebecca pointed out imposes a de facto moratorium, and the other is time for research, which has given rise to a certain debate.

But there are at least two other reasons. One is the reason that was mentioned by Dr. Kass from the very first day when he spoke about the purpose of this commission, and that is to raise the level of the national conversation.

And I would think that those who favor a moratorium for purposes of preparing regulation would also include among their reasons the idea of having a broader public debate, the kind of deliberation that we expect in a democratic society and that we haven't really had yet in the United States about these complicated issues.

So, Frank, these remarks are really addressed to you. It seems to me that what you are proposing is not a hybrid of three and six, but rather something that fits quite comfortably under six, that is ban plus moratorium.

And the reasons for the moratorium would include in your case probably preparation of regulations and public deliberation, maybe time for more research or maybe not, and there are many of us who might have a combination of all of those reasons or various combinations of those reasons.

So that I just ask you to think about whether you really need to have a whole new category or whether you'd be comfortable with the sixth one.

PROF. SANDEL: Could I just address a quick question to Mary Ann?

Would those be reasons for you to prefer moratorium to a ban on both?

PROF. GLENDON: I'm comfortable with alternative number six.

PROF. SANDEL: But how would you answer the question whether they would be reasons on balance to prefer the moratorium to a ban?

PROF. GLENDON: Well, I'm going to sound like a law professor now, but I don't think that — I think one can exaggerate the difference between moratorium and ban.

One of the glories of legislation is — and here I have to quibble a little bit with something that Leon said. You described the ban as forbidding permanently.

CHAIRMAN KASS: Yeah, that's always reasonable.

PROF. GLENDON: Legislation can always be revisited, unlike court decisions on constitutional grounds, which are much more difficult to revisit. So I don't see the distinction between ban and moratorium as crucial.

CHAIRMAN KASS: Bill May and then Gil.

Did you want just a quick word? Sorry.

PROF. FUKUYAMA: It's funny that you're pushing now back to six because I was actually persuaded by Rebecca and Michael on three interpreted, you know, as a de facto moratorium just for the following reason.

If you had to delay research cloning until you got a regulatory system in place and made that link explicit, it would give a real incentive to put that system — you know, to get that thing up and running. Whereas if you simply had a moratorium with, you know, a general idea that you wanted a regulatory system at the end of the moratorium, you could easily imagine the moratorium expiring, everything going back to everything is permitted, and the regulatory system, because of all of the problems in getting all of the interest groups lined up, you know, and so forth simply not materializing.

So I actually — again, I hate to fall back into these tactical considerations, but I actually am sort of persuaded that three interpreted as a de facto moratorium may actually be preferable to my earlier combination of three and six or your, you know, interpretation of six.

CHAIRMAN KASS: I've got a queue. Bill May and then Gil.

DR. MAY: The earlier discussion of the intermediate status of the embryo, it seems to me, has a double implication, and most of the emphasis if followed is that it allows for research as opposed to those who think of it as having full participant status.

But the other side of that is that it necessitates regulation, and we shouldn't lose either side of the implications. It's the moral implications of that status, it seems to me, those who hold to that position.

And I will repeat what I said earlier. It seems to me that the implications of that status raise issues not simply about time limit 14 days, informed consent and so forth, but powerful restraints upon commercialization, both in the production of knowledge and therapies, which is what I think Rebecca has emphasized, but also in the distribution of knowledge and therapies, the access to it.

And that broadens out the whole question of the health care system in this country, and I know we can't take that on, but it seems to me when you state regulations, you have to point to that. How one makes that operational is a very difficult question, but it seems to me it cannot be ignored in any final statement about regulations.

I don't think I can carry any farther than the conversation exchange between Elizabeth and Leon, but I want to bring into the discussion something that Michael wrote in one of his memos.

The argument that we may too easily assume that there are alternative modes of research because there's a difference between left over embryo research and cloning for biomedical research, and as I recall in your New York Times op.ed. article you pointed out that morally really they stand together.

And if that's the case, if research on leftover embryos is not essentially different from cloning for medical research, they stand together or they fall together was, I think, the point that you made in your statement. Hence, either forbid them both or do both.

And if you don't say forbid them both, then maybe you will get faster to the answers to the question of possibility and necessity that Elizabeth is talking about, if you see that at least those two forms of research really stand closer together morally than has been previously assumed by a lot of us.

CHAIRMAN KASS: Gil.

PROF. MEILAENDER: I want to try my hand at reinforcing the point that Mary Ann made because I think it's important.

I preface that by saying, I mean, in my own ideal world, we would ban research cloning simply because we would ban cloning. I mean, there's a sense in which I haven't been happy from the start with the distinction.

You will remember we had the terminological wars for a while, and we've kind of arrived at a way of talking about it that I'm happy to acquiesce in so that we can talk about it even though it actually distorts to some extent my own view of the matter, but I mean, we have to talk, after all.

I'd be happy to have this Council make no policy recommendation. I don't actually think it's all that important, to be honest, as compared with the fleshing out of the arguments and the explaining of the rationale in both moral and policy terms. That would please me all right, too, although I'm probably a distinct minority on that point.

But, I mean, there is something to be said for the moratorium language, and I thought, Frank, you needed to take a little more seriously Mary Ann's point, that is to say, one way — and, Michael, it comes to your point about kind of respecting alternative views. One way of doing that is that it's conceivable that several people could come together agreeing on such a recommendation over quite different reasons, and you wouldn't necessarily be endorsing everybody else's reasons in doing that.

If I were to support a moratorium, it would be precisely so that the moral argument can continue. I mean, I wouldn't really support it so that we can get regulations in place, since it is, after all, not an activity that I want to proceed with regulation, but you know, I could have my own independent reason.

Somebody else might share several reasons, but I mean, that is a way of trying to take seriously the concerns and the moral positions of several different people without setting aside one's own.

I mean, what Mary Ann has pointed to is an independent kind of reason why it's at least a possible policy option in my mind, even if, I suppose, in the best of all possible worlds not the best option as far as I'm concerned.

CHAIRMAN KASS: Okay.

PROF. FUKUYAMA: No, I do take very seriously, you know, Mary Ann's, you know, urge that we need to have this moral debate, but I can think of no better way of stimulating that than actually having on the table, you know, concrete legislation for regulating this area. I mean, that's what drives the editorial writers and, you know, the think tanks, you know, to actually talk about some of these issues.

Whereas simply a moratorium that doesn't actually — isn't connected to a concrete, you know, public policy I think risks just sort of continuing. I mean, debate will continue, but I really — you know, for example, the stem cell debate that we had in 2001 was driven by the fact that there was a timetable for the administration to announce a new stem cell policy, and that's really what I think got everybody interested in learning about stem cells and, you know, editorializing and so forth.

And so I do think, you know, that three would achieve a lot of that purpose of stimulating, you know, the public discussion about where we're heading.

CHAIRMAN KASS: Who do I have next? I have Dan Foster.

DR. FOSTER: My recollection of the last meeting, and I just want to make one point about the options of adult stem cells that I know that seem favorable to many people, that at the end of the conversation, the discussion — I haven't gone back to look at the transcript, but I believe that when — and I haven't seen the Nature paper that's supposed to come out, but I believe that in her discussions she also made the point that her own laboratory was proceeding in terms of embryonic stem cell research because of the fact that there needed to be comparisons between here, and the she herself was not at all sure that the adult cells were going to do.

So, I mean, one needs to remember that the leading proponent of adult stem cell herself has said we need to advance in terms of these other issues.

And unless my recollection is wrong, I think that she did say that, and I believe that Gearhart also made the point that both issues need to look — and they may act differently. You certainly can't — I don't think you can compare without comparison. The same thing, if you look at zygotic embryos from leftover blastocysts, I mean, I have considerable concern about the rejected blastocyst, about the long-term storage in terms of freezing, in terms of deterioration and mutation and those stored blastocysts.

So they need to be compared with freshly made stem cells if you really want to try to get the information because they might be worse by far in terms of any — but you only know that if you look at it to see.

And so to have a moratorium in some sense says, just as Elizabeth said, that you'll never get the information that you want because a scientist would want to get the facts, and if we can say that adult stem cells are better or zygotic stem cells are better, then that would be one thing and we could stop all the other things.

But, on the other hand, if there's a vast difference, we have to know that. I mean, the late Bertrand Russell said something's pretty interesting, I think, and he said the only definitive information comes from science. Dogma comes from religion, and in between is the vast no man's land of philosophy.

What is the evidence? I mean, a scientist would say you have to have evidence. Now, if you think that the way of getting the evidence is absolutely reprehensible, as I guess Gil does, then I would say that he shouldn't modify. I agree with Michael here. He shouldn't modify his stand, and I would respect him for that.

He ought to say no. I mean there's some statement in the document — I know we're not supposed to say it — that no morally unacceptable act can ever be done for any good. I underline that statement.

So if you've got a sniper on the University of Texas tower who has killed 27 people because it's morally unacceptable to kill somebody under any circumstance, then you could never, you know, do that.

So I would say I don't want — I mean, he chastised me on something I said from Augusta in a gentle way, but let me — wait a minute. I'm not quite through.

PROF. MEILAENDER: I'm coming again.

DR. FOSTER: I'm not quite through, but I would much prefer you to simply say, I mean, I don't think this kind of compromise to accomplish a ban like this is really the sort of honesty that you always have reflected on your views.

I understand where you stand. I don't agree with it, but I understand it. So I would much rather have you say, however we come out of this, I don't want to do this no matter how much good can come out of it rather than to say I want to vote for a moratorium so we can get a report out that everybody buys into.

So two points. One is a scientific point, and the second has to do with just your remark. I think we ought to honestly say what we believe here, and whether it's policy or whatever.

CHAIRMAN KASS: You got him once. I got him the second time. Go. No, I'm going to be silent. Let Gil speak.

PROF. MEILAENDER: Just so we're clear, were I to support a moratorium, I would understand it as saying no. All right?

It might mean I'd have to persuade you of that no again four years from now, but that's what I would understand it as saying.

Frank, I think, would understand it a little differently. It doesn't mean we wouldn't at a certain level support the same thing, but that's the way I would understand it, and it seems to me a plausible understanding.

CHAIRMAN KASS: Let me make — I've got a queue of three people and then we'll break for lunch and return. I've got Bill Hurlbut, Mike Gazzaniga, and I think that's — I just wrote Mike. That must be you. Yes?

You can wait until after lunch? Paul? I'm sorry. Did I miss you? Your name is down here scratched out. Have you not spoken?

Bill Hurlbut, after lunch? You can see where the priorities of this body. We'll take a break. We'll reconvene at two o'clock.

(Whereupon, at 12:32 p.m., the meeting was recessed for lunch, to reconvene at 2:00 p.m., the same day.)


SESSION 3: HUMAN CLONING 12: PUBLIC POLICY OPTIONS


CHAIRMAN KASS: I think we're all here. We're expecting Charles Krauthammer who is traveling and I hope he hasn't been unduly delayed, but he said he'd try to be here for this afternoon's session.

We're in the middle and I don't think I'll even hazard a summary and just allow us to continue where we were. And people who I had on the list previously included Robby George, Bill Hurlbut, Mike and Paul — Bill Hurlbut, Mike Gazzaniga and Paul. Have I omitted somebody who — okay.

Robby, would you like to start?

DR. GEORGE: I want to respect Frank's desire not to get into the big debate, at least not here, but I did want to at least offer a clarification from my point of view about what the debate is about because I think that the examples that Frank raised when he was talking about the political and civil rights of children and the question of the status of human corpses, I do want to clarify what I think the debate is about that we've been carrying on, at least to some extent in submissions that many of us have made to the Council.

I think it's about the question of what confers upon the human being at whatever stage of development, a status that is sometimes referred to as inviolability and whether one and the same substantial entity can be morally inviolable at some stages of development, but not morally inviolable at other stages of development.

So as I see it, we've got a dialectic going on, at least between those of us who think that the embryo deserves full moral respect than those of us who think that the embryo deserves intermediate status or I think what we've been referring to as special moral respect.

And the argument has been going back and forth and I do hope that it will continue to go back and forth because I think it's kind of hanging in mid air. Those who have argued for the special respect view have presented some arguments including the question of an argument based on the possibility of monozygotic twinning prior to 13 or 14 days of embryonic development. The question of the high rate of natural pregnancy loss, our emotional responses to miscarriages as distinguished from the loss of children at later stages of development and so forth and I think that those of us on the other side have proposed responses and counter arguments to those various points and I hope that this debate will continue because I think that it's an important one.

Of course, there's also the point that Michael Gazzaniga has pressed about the importance of brain development and there's been a response from me and from others to that as well and I think Michael has now responded to our response, so perhaps on that one the ball is in my court and others who have my point of view. I actually have something drafted to submit on that. Perhaps others do as well. But I do think that this debate should continue and that we shouldn't simply say well, look, we're not ever going to convince each other on something like this. Perhaps we won't convince each other, but I think we can better inform each other and who knows, but that minds yet could be changed one way or the other.

That was my first point. The second point I would like to frame as a question to the scientists on the Council, I have heard that there's at least speculation that it might be possible to avoid the basic question that vexes us, at least some of us on research cloning of the moral status of the embryo. By the deliberate create of entities possessing a human genome, but lacking other features such that people who believe that the — as I do — that the human embryo, strictly speaking, is morally inviolable, would not consider the entity to be — that has been produced to be a human being or an embryo strictly speaking, but that nevertheless, the entity could develop in such a way as to make the extraction of stem cells possible. And I wonder if scientists on the Council just happen to know the factual answer to the question whether that is within the realm of possibility.

The third point is completely unrelated to the other two. And that is the question with respect to what we've been calling reproductive cloning and anticipating as a moratorium or ban on reproductive cloning. What is it that we would be proposing to ban when we propose to ban reproductive cloning? Would the crime or offense be the creation by somatic cell nuclear transfer of an embryo with the purpose of implanting the embryo? Or would the crime or offense be the implantation of an embryo that was created by or brought into being by somatic cell nuclear transfer? It seems to me that quite a lot from an ethical viewpoint might depend on which of those is what, in fact, is being proposed. So it's something that I hope will at least clarify and if we have different views on what it is that ought to be banned, perhaps those could be gotten out onto the table.

PROF. SANDEL: I'd just ask, Robby, a quick question. Which of those do you think would be ethically less objectionable?

DR. GEORGE: The ban or moratorium on creating, on synthesizing or creating, bringing into being an embryo by somatic cell nuclear transfer with the purpose of implanting.

CHAIRMAN KASS: I have to tell you, just as a legislative matter, I shouldn't be telling you, you should be telling me, that if one wants to prescribe a certain activity one wants to prescribe it precisely so people will know what it is that is wrong and approving intent is difficult and to make the crime to create the embryo with the purpose of implanting it would lead to the following situation. Person 1 produces the embryo with the purpose of using it for research, gives it to Person B who then implants it and neither of them does anything wrong. Anybody who wanted to prevent this activity would never write the statute the way you would find it morally — easy to support. That's the difficulty.

DR. GEORGE: Well, I do think it would be difficult to draft a statute and any statute that you drafted would have loopholes and there would be cases where people would actually get around the law. I do think you could probably draft it in such a way as to impede the development of a commercial human reproductive cloning industry.

CHAIRMAN KASS: Point taken.

DR. GEORGE: I wonder if anybody knows the answer to the question?

CHAIRMAN KASS: Did someone respond to the first question about, if I understand the question, is it possible to produce — precisely because they're not embryos, they might be — they would not be inviolate and therefore, but they might be perfectly good for all the research that one would like to do.

DR. GEORGE: The closest thing I can think of to it in nature would be a hydatidiform mole, but a hydatidiform mole that or like entity that would be sufficiently differentiated to make possible the extraction of stem cells.

Does anybody know anything about that?

DR. BLACKBURN: I think there might be an issue in which the DNA would be the same, but what's called the imprinting of the DNA which can lead to these abnormal outcomes like the hydatidiform mole, that would be different, so that would have some commonalities with the normal embryo that had been normally imprinted, but it wouldn't be the same.

I honestly don't know what you're referring to, but perhaps that's what you're meaning.

DR. GEORGE: That is it. If I understood you correctly, I think that is what I'm asking.

DR. BLACKBURN: So the imprinting that is happening is probably, as we've seen in various written documents, much of the source of the problem with getting cloning, for reproductive purposes to work in animals, that it doesn't happen very well, even with somatic cell nuclear transfer of a diploid cell into say a human egg, well, this hasn't been done, but into a mouse egg.

So I'm not sure whether you had that in mind or Bill had proposed something. I didn't know whether that was what you had in mind as well.

DR. GEORGE: Well, maybe Bill could say.

DR. HURLBUT: Well, on the end of my comments for my moral position, I added what I call a speculative proposal. I apologize for the length of it and maybe some of you didn't get that far. But it was what it took for me to think about the issues.

And I formulated that with some conversations with scientists, Paul Berg sparked some of my ideas and Irv Weissman, and others, and talking with developmental biologists, and then thinking about the theological issues, theological objections and some of the traditional medical and legal objections, it struck me that if the objection hinges on the potential of the embryo, that actually what we're going on about here in our disputes about the status of the embryo is pretty much the meaning of potential, whether potential is in a sense actual or sort of theoretical.

Well, if you could render the potential not there in a certain sense, then you couldn't say that there was in any sense personhood present or human inviolability, even if you don't say personhood. So it struck me that if you could do some simple gene transformation, alteration of the cytoplasm or maybe even alteration of the culture medium, that maybe there would be a way to say we've created what Paul's been on to, an artifact.

And I have to say I sympathize with it to a degree to what Paul says because it feels like a lab procedure to me. But what troubles me with Paul's point of view is that you could implant that entity and it would become, I'm convinced, a person. Paul, whether you think fully human or not, I don't know, but I'm inclined to give it that.

So what if we could render it sort of disarm — I hate to even use the word embryo, but disarm it and take it to the most extreme. If you could do a nuclear transfer that was missing a chromosome or something like that that wasn't necessary for the production of anything — or put it another way, it was essential for the production of an embryo, but wasn't essential for the production of say a kidney, well then you could do this lab procedure without having the moral problem present. You think, Robby?

DR. GEORGE: This is precisely what I'm asking. And what I'm interested in right now is not the ethical issue, but simply the factual — the question of whether such an entity could be brought into being. And by that, I mean is there some lab that could do it tomorrow? Is this the kind of thing that if people put their minds to it, could be accomplished in the foreseeable future.

DR. HURLBUT: Well, I've had numerous conversations with scientists about this and it sounds to me like this could be done. Not only that, but scientists told me yesterday that you could first render the gene inoperable and then reverse it when you had the stem cell isolated. I know it sounds like a technicality, but so what? There are important principles here.

And I see this as a way to go forward with the science even better than what's proposed in a sense because we know from — I don't think so much hydatidiform moles. We know from teratomas that you can get whole portions of a body like teeth, fingernails, hair wrapped into an ovarian tumor. So we know that you don't have to have the whole embryo present to generate partial parts.

So what I'm interested in is parts apart from wholes and partial generative potential. And Janet and I were talking about this over lunch and based on a preliminary conversation seemed like Janet — I think there were some possibilities. What do you think, Janet?

DR. ROWLEY: I haven't had any time really to think about how one would do this practically. It's certainly in the laboratory, there are ways of putting genes under the control of say tetracycline and in the presence of tetracycline, the gene is operative and when you withdraw it, the gene becomes inoperative or vice versa. There are a number of different strategies called that lead to conditional expression, but how you could get such a system to work reliable such that you could put such a genetically altered nucleus into a somatic cell nuclear transplant into an oocyte and expect the oocyte to grow under those circumstances to give you a multicellular embryo, I'm totally ignorant of whether such a strategy could work or alternatively when you do just removing genes through homologous recombination and just alter a single gene which can be done in the laboratory and obviously mice are developed and live with such altered genes. But how applicable that is to the human situation, I'm totally ignorant of.

DR. HURLBUT: Well, let me give you a suggestion. Suppose you rendered a gene essential for angiogenesis. This is the production of blood vessels. Suppose you rendered that gene inoperable. Clearly, you'd never get an embryo, but you don't need that gene because for stem cell, simple stem cell transplants, they don't need to generate their own blood supply, so you could theoretically deactivate a gene essential for embryological formation that was not essential for the uses you wanted to make of the cells or tissues, and claim a good moral position and also good science at the same time.

What do you think, Elizabeth? Is this maybe a break to the impasse?

DR. GAZZANIGA:: I think this is nutty.

(Laughter.)

DR. GAZZANIGA:: That's a technical word.

CHAIRMAN KASS: Next argument.

DR. GAZZANIGA:: The notion of doing a gene knockout that will selectively hit — let's go for your pet topic, the soul, so therefore this thing that — this blastocyst doesn't have it and the notion of doing away with the embryo by not giving it the genes for the blood supply — well, it's just another form of doing the deed. So I just think this whole — this does sound Frankensteinian to me and it gets into all kinds of convoluted reasoning that doesn't make much sense.

DR. HURLBUT: It's not at all —

DR. GAZZANIGA:: On the positive note though, on the positive note and going back to Mary and the dilemma this morning or suggestion, I guess it was. A lawyer never has a dilemma, they just have suggestions. I looked up what moratorium means because I thought we were sliding around with the definition and the definition is a legally authorized period of delay on the performance of a legal obligation. So I assume that's correct. That would mean that if one signed on to a moratorium, it would men that they would be open, I assume, once certain issues were cleared up to go ahead with the intent of the act for which there is a moratorium, for which a moratorium has been placed on it. Is that going too far?

PROF. GLENDON: That's one definition.

DR. GAZZANIGA:: Definition 2 is a suspension of activity. Is that what you mean by it? So it's another — you mean there's truly an equivalence between ban and moratorium.

PROF. GLENDON: A temporary ban.

DR. GAZZANIGA:: But temporary then means you're ready to go to action once all the issues have been cleared up.

CHAIRMAN KASS: Let me clarify. Since the term comes from headquarters. It wasn't taken from the dictionary. It was meant to indicate a ban for a limited period of time which unless the ban were reinstituted would automatically lapse, whereas a ban which doesn't have a fixed limit on it requires someone to make an argument to lift the ban. That's the difference.

DR. KRAUTHAMMER: And the word already has a historical use. It isn't as if it came out of a dictionary yesterday. We have had a moratorium on nuclear testing. Everybody understands what that means, the temporary ban which if and when it expires, is reversed.

CHAIRMAN KASS: Let me say this is not the place, I think, to argue out the possibility or impossibility of these modified beings that may or may not be whatever they are and that it would make them suitable or not suitable for experimentation. The possibility has been noted. It is at this point speculative.

DR. GEORGE: I think, Leon, that it is relevant. I'll tell you why I think it's relevant.

CHAIRMAN KASS: How would it be relevant to deciding in the next week, month, three months, six months, one way or the other on what is before us?

DR. GEORGE: I think it could affect someone's judgment as to whether they think a moratorium is appropriate.

CHAIRMAN KASS: I see. In other words, if he told you scientists are working on this and they will find you something —

DR. GEORGE: That within two years you could, it's realistic, that there could be an unobjectionable entity from which we could extract stem cells and even the people like myself who believe in the inviolability of the human being at the embryonic stage as well as all other stages wouldn't have a problem with this. That might lead some people who might otherwise be for going forward right now with it to the thought that well, gee, our fellow citizens do have some grounds for their moral objection. I don't happen to share it, but if there's a way to avoid putting them in the position of — that they would be in.

CHAIRMAN KASS: I understand. Thank you.

DR. FOSTER: The one thing that I would say and I agree, we need to move on is that within the realm absent some miracle from the deity to speculate that within two years that you would get something like this working, all these chromosomes act in all different ways. I mean one of the problems of the genome is that you can't take some isolated thing out and expect to get the VEGF which is the key angiogenic early has many other effects in the embryo than it does in forming blood vessels. Everybody knows that. And as a consequence, to say well, I'm going to knock out — that's vascular endothelial growth factor, you know. VEGF is just one of the angiogenic. It does many other things. It controls other genes and so forth so the idea to me, I'm not a developmental biologist, but I certainly would be skeptical that many scientists think this is — I mean I'll check this out myself, I don't know, because we have very good, but I think to put an early time limit on that would be very unrealistic. It would — and then even if it's a good idea, I'm not sure that it's going to apply in the short run, Robby. I just don't know, but I'd be very interested to know what Paul — I'd be interested to know what Paul Berg said about this or others. I just don't think that's possible.

DR. HURLBUT: Let me clarify it. I didn't mean to say that Paul Berg is endorsing this, but I've talked with him about it. I've talked with Irv Weissman. I've talked with other developmental biologists. I agree with what you say, largely the genes operate in important ways that are much more complicated than one gene, one trait. I'm not arguing that. But we do know from teratomas that it's possible to produce parts apart from the integrated whole.

I think what I'm trying to do here in suggesting this is I don't think inappropriate or nutty. Frankly —

DR. FOSTER: By the way, I did not say nutty. That was Mike. So turn —

(Laughter.)

DR. HURLBUT: Well, let me just say this. Frankly, I wouldn't be very satisfied, personally, if after the effort we've all put into this and the importance of the issue are taken account of, that this Council comes out with just a more articulate restatement of what the public already knows are the central issues. I personally think if we could define the boundaries of the moral problem more clearly and at least make some, clear some territory for if you could do this, you would have the consensus, I think that would be a real contribution and I don't think what I'm suggesting is unrealistic and neither did certain developmental biologists I talked with. And I think it's important that we work for moral consensus in our society as we go forward. This is a much more hotly debated and deeply felt issue than is sometimes acknowledged within the scientific community. And I think it's our moral responsibility to see and listen rather than just spend 30 seconds on a subject. If somebody comes up with a proposal, I think we need to explore whether it's a reasonable way to proceed and not just label it nutty.

DR. BLACKBURN: Could I add something? I see a parallel which may be a constructive one. In the debate on recombinant DNA, I think — Bill, correct me if this is correct analogy, but the proposal that was made and was enacted earlier was to have strains of bacteria which were unable to survive outside the laboratory. So I think that is an analogous situation to what Bill is saying.

Now the difficulty that we've been alluding to, Robby, is this internet work sort of behavior of genes. I'm just thinking of a gene that one of my colleagues found to do with the immune system. It was key. He thought it was absolutely only involved in the immune system, but it turned out to be involved in the development of the nose and all sorts of other things as well.

So I see the idea, I think, and am I understanding that you're saying that you think that something that would allow a certain portion of the development of the embryo, that you'd know it could never become a full person, would be an acceptable proposal? Am I correct?

DR. GEORGE: I would put it in different language, I think, Elizabeth. But I think you understand where I'm going. In other words —

DR. BLACKBURN: If it could never live to be a baby.

DR. GEORGE: No, not that it could live to be — in other words, it would not be — it would lack the epigenetic primordia for self-directed growth to the next more mature stage on the continuum of life. That would — in the way, for example, that a teratoma would, despite possessing a human genome. Right?

DR. BLACKBURN: I think the concern would be to sort of make that a condition because as Dan says that mightn't be easy to put into practice.

DR. GEORGE: This is really my question.

DR. BLACKBURN: At least if it were one of the proposals out there to — I think it's something to consider, but I think at this stage it wouldn't be realistic to say oh, we could do this now, so therefore let's make this the way to do it.

DR. GEORGE: Oh no, I understand that. I'm not asking whether it can be done now. Although I think — if we knew the answer to the question, is it reasonable to suspect or to hope that this could be done in the next few years. I think that if the answer to that question were yes, it could factor significantly into the thinking of some people about what policy they think we ought to adopt now even if they don't share my view about the inviolability of the embryo.

DR. BLACKBURN: I think people could try, attempt to do it, but I think there would be absolutely no guarantee that it would —

DR. GEORGE: No guarantee. I understand that.

DR. BLACKBURN: Right.

DR. GEORGE: How would be obtain better information about that, about that possibility? I mean is it out there and we just don't happen — the people here just don't happen to do that kind of work or is this just something nobody has ever thought of?

DR. BLACKBURN: I think it would a type of the work that I had alluded to in the morning session where one would be doing somatic cell nuclear transfer type of development of stem cells. And then using the kind of approaches you are talking about and saying ah, can we now modify that process. I think it would be very hard not to do the kind of research that would involve somatic cell nuclear transfer and getting to say stem cells out of it, to get the answers out. But once one had the answer out, then one could say, okay, well, there is a way that now would be doable perhaps. But I don't know — I can't think of how you could find that out, actually without being in control of the beginning material for the experiment. Could you do it with excess IVF embryos, for example? I can see that might be tougher.

I haven't thought about it enough either to be honest.

PROF. SANDEL: Could I just ask Robby a quick question. On the first part of his comments, not on this issue.

DR. GEORGE: I want to say — go ahead that's fine. Go ahead, Michael.

PROF. SANDEL: Going back to the moral status —

DR. GEORGE: The moral status, yes.

PROF. SANDEL: Would you say given your view of the moral status of the embryo that cloning for stem cell research is morally worse than reproductive cloning, where after all, no person is killed?

DR. GEORGE: Oh yeah, I thought I had made that clear. If I hadn't — yeah, I'm sorry.

Just a final note on that since Michael raised this question of the soul, I hope jocularly. It has circulated, I mean sometimes it seems to be an assumption that those of us who are — who believe in the moral inviolability of the embryo believe that on the basis of putatively revealed propositions, religious propositions or theological propositions about the presence of a soul, I don't think that that's the case, as a matter of fact. And as far as I can tell, I think Daniel alone has raised the question of the soul or presence of the soul as relevant to a determination of the moral status of the embryo. I certainly have not in any of my — we've now had four meetings. Any of my interventions, I don't think any of the submissions that have been made have raised that issue, so I don't think that we've got here a debate about revealed truth.

CHAIRMAN KASS: Could I intervene here? We've got about another hour to go on this topic. There are people in the queue. I don't want to demonstrate disrespect to the suggestion that's been offered. I understand both why it matters to Bill, Bill Hurlbut, that if there is, in fact, a way to use our science to get around what is for many people a profound moral objection to doing this, that would be very nice to think about and to do, right? That's a creative thought which hasn't generally appeared. I also see its relevance for someone like Robby who by and large wouldn't be in favor of anything other than calling for a ban. I'm simply assuming. He might go along with something more temporary. One of the things that might lead him at least to think about it is if he thought the intervening time might actually provide him with an alternative, might provide us all with an alternative, now not available.

I think if I could say that that's — and if there's great uncertainty with varying degrees of skepticism around the table, but without a lot of evidence at the moment, and if people would like to gather further evidence on this matter and maybe Bill would like to provide it, I think we should have it, but there's no way in the world I think that we here can do much more on this than we've done and I think we should, if it's all right, I would like to move back to the options themselves that are here and not the various possible reasons that might ultimately be one way or the other.

Bill, you're next in the queue, so you can just rebut the Chair's admonition that we try, I think to come back. There's still people who want to have their first say on what they think we should do. But the floor is yours and if I've done you an injustice, please correct it.

DR. HURLBUT: A fortuitous sequence.

CHAIRMAN KASS: It's just there.

DR. HURLBUT: Actually, I'd like to first ask Janet a question and maybe Elizabeth too. How important is it that we come up with a solution that opens up the possibilities for federally-funded research? Obviously, we could do nothing and the private research would continue, but how important is it for federally-funded research to be opened?

DR. ROWLEY: Well, I think it's extremely important for federal funding to be available to scientists on some of the issues we have said are important to get answers on which we cannot at the present time obtain answers because of the lack of funding and I point out that this has been a ban for a number of years. I know Clinton reaffirmed that there could be no research using embryos and embryonic stem cells.

There is now, of course, with President Bush's allowing the use of cell lines, I understand that the first serious of grants has actually been reviewed and funded, I believe from NIH in that particular, using that particular source of cells, but I think that many of the questions that we would like to know the answers to, to come to a much more informed judgment ourself are presently prohibited, so we just have to wait for scientists in other countries where they do have the opportunity to do this research to provide us with the information.

DR. HURLBUT: Can I ask Elizabeth the same question? How important is it that we able to do things like nuclear transplantation at the university level, not at just the currently accepted private level?

DR. BLACKBURN: Well, some of my points this morning were addressed to why I think that kind of research is very important. As to the setting of it, I think that if one grants that the research is important to be done, then the university setting which is an open setting, where there is review, where there is critical input, much better information made the quality of the sciences generally going to be much better, will use the resources that the country has in terms of its brain power to do it right.

So my view, that's the way research really does get done right in that kind of environment because I think while there are talented people in industry, they're not guided by the same sets of imperatives, necessarily, and one also doesn't have access to it and the information about what the quality control has been in the same way as the more open sort of scientific community which is exemplified by universities. In my view, it's very important.

DR. HURLBUT: So I want to make the point that this is what I've heard from all the scientists I've spoken with that we need to open up the broadest possible, morally acceptable science at the level of basic research because without that, first of all, as William May said earlier, that it's hostage to proprietary interests and secrecy if it's in the private sphere only. Is that what you were implying, right?

That's unfortunate, plus there's kinds of research that can be done at the university level that won't be done in the private level. And the science can go forward more rapidly if it's broadly published, so this is why I think it's very important that we not — that we define our moral boundaries carefully, that we see if we can find a way scientifically to work within those moral boundaries. I'm not very political and I don't want to pretend I know what's going to happen, but I think I'm awake enough to know that even if our counsel were to unanimously vote in favor of all kinds of cloning, that that's not going to happen because our President has plainly said that he will not favor that. So it would take, at least I guess two-thirds of the Congress to override that. And that doesn't seem imminent.

So it seems to me very worthwhile for us to try to define what the moral boundaries are and seek, at least to tell scientists what they might work toward. I just feel like that's the direction to go and if it takes a little bit of speculative proposal, so be it. At least it clarifies to us what our moral positions really are.

CHAIRMAN KASS: Mike Gazzaniga. You were on the list before lunch, maybe you ate too well. Okay. Paul McHugh.

DR. MCHUGH: Yes. When I came after having read the draft of Chapter 7, the moratorium idea seemed perhaps right. There are a number of reasons I thought that. One of them was Mary Ann's point. It would continue the conversation and perhaps win people over even to my idea that this is a better way of looking at these clonotes and that the clonote and the zygote were distinction with a big difference. But even more so, a period of time we've already talked ourselves and we're still making progress in the conversation and so more time perhaps would do as well.

I also felt that a moratorium might also show some respect from each of our points of view to the other points of view about not only of our members here, but of the feelings of people in the country, feelings that derive from their points of view, some of the feelings that derive from their religious points of view, that that might be able to be done during a moratorium. And it would be a clear gesture of ours to the sense that we are pluralistic society and that there are voices that we want to respect and that thirdly, that there would be more opportunity for research that would go, particularly in animal research that would do a number of things for us. Particularly, I thought it would reduce the hype around this and get us knowing more about what we had and what we could accomplish and it would, for example, also bring up more issues in relationship to the adult stem cells.

But in the conversation today and this morning, I began to wonder whether a moratorium was really the right thing because a moratorium, I think has to have a particular meaning. You have to — really, it's not just the inchoate feelings that I have about what might happen during this time, and what I might wish, but it has to have some meaning and for a reason not only to have it, but to give it a particular time. And it was when I thought about the time that was going to be given to what has sounded now more and more like a ban, I begin to worry about time because time is of the essence in this, if like me, you have to talk to patient populations about the possibility or the probability or the may be possibility of their treatment.

Remember, if this work goes forward and the science goes forward with it in any time, there's still going to be lots of other times that are required because we're talking about therapeutics and you're going to have to get into the FDA business and the Phase I, Phase II, Phase III and we know that there are years and years that are going to come. Even if we have a terrific discovery tomorrow, there's going to be years and years of trials before it will be available and for the patients that we're talking about time is of the essence.

And so as I thought then about the moratorium and I listened to Rebecca and to Frank and to others, it seemed to me that perhaps we were talking against what I feel and hope for patients and for this possibility and that maybe the idea of working, considering a de facto moratorium as we work out the regulations would, in fact, accomplish all the things that I had wanted for a moratorium. It would, by giving a further arena of debate as we were talking about licensing and things of that sort, allow people, well, allow people to listen to me more about what we were feeling; think about what Bill has proposed. By the way, I think this idea is a very good idea. The coincidence of it, showing that this idea is just around the corner was that the day before I received Bill's e-mail and old friend had raised exactly the same question to me, but I didn't have Paul Berg to go to, but when I got your kind of reinforcement, I thought yeah, well, that's what our talking is supposed to do. It's supposed to bring these things up for us to consider. And since we heard this morning that it takes four, five, six years from even the beginning of some gesture in this to get a regulatory body up and running, that would accomplish pretty much what the moratorium would be trying to do, it seemed to me.

So that given the fact that time is of the essence, that there are very important things both at stake in the moral issues, but also at stake in the clinical issues, I'm moving towards issue 3 and feel that it would accomplish all the things that I had wanted to accomplish when I came.

CHAIRMAN KASS: Alfonso and then someone else.

DR. KRAUTHAMMER: Excuse me, could I ask a question just on the meaning of 3 of Paul? You then would say ban present regulation with the understanding that there would be a moratorium imposed until the regulations are issued or would you be permissive in the interim? Prohibitive in the interim, rather than permissive?

DR. MCHUGH: Yes. Because it would be licensing that would be at issue in the regulations, I would be prohibitive during that time.

DR. KRAUTHAMMER: Is that how we are to understand Option 3? Because as I read it, I would have assumed the ban plus regulation means that research cloning would be permitted and then regulated at a later date. I just want to understand what you mean by that.

CHAIRMAN KASS: Certainly, I think that since no one in the current debate has been proposing that we set up a body like the Human Fertilization and Embryology Authority, the more liberal of the bans being proposed in the Senate on reproductive only, at least to this point have barely gestured in the direction of regulation. The original bill, even the modified bill talks about certain rules at the NIH that govern experimentation on human subjects and that means everybody but the embryo. I gather that there's some proposal now that there might be an amendment saying nothing past 14 days, but no one over there is thinking about setting up a regulatory agency that would then have to take these things under consideration prior to the existence of which nothing would happen.

So I read Proposal 3 as not being — the people who tried to collapse Proposal 3 and Proposal 6, I think did so erroneously. Proposal 3 would be some new legislation now that's set forth a few conditions, but that didn't really establish the kind of regulatory system that the British have. It's perfectly possible for that to be modified by saying look, I don't want to join a moratorium for any reason other than my interest in regulation and therefore we beef up Proposal 3 to include precisely that this research is prohibited, unless and until a regulatory body was in place and that addressed the questions of commercialization that addressed the question of duration, of licensing, of all of those things that one saw that seemed to be common practices in the British and Canadian system. That's a possible recommendation that we could make, but as it appears here, we could dress it up that way if that is the way people would certainly like to go.

Janet?

DR. ROWLEY: Yes, I'm surprised at your statement because certainly the National Academy report recommended that there be a regulatory body that would be established and I guess I had assumed that in the Feinstein bill, there was something about regulation, but I don't remember the details.

CHAIRMAN KASS: I don't think that's accurate. There's some reference to guidelines that are operative.

Rebecca, do you know, do you recall

off-hand?

PROF. DRESSER: I think you're right, although I would like to see it again, but that's my recollection.

I didn't interpret 3 the way you were interpreting. I interpreted it in the more restrictive way, so I don't know if Frank had that same interpretation.

CHAIRMAN KASS: Well —

PROF. SANDEL: I also want to address this because it seems to me that this Council can define Option 3 —

CHAIRMAN KASS: Absolutely.

PROF. SANDEL: However it wants to. Moreover, we already can easily imagine language that would provide exactly the understanding about licensing and noncommodification that Rebecca and Frank and Paul and Charles have raised just now. The language wouldn't be hard to draft. We could say that it would have — a regulation would have to include (1) establish a number of days, whether it's 14 days or other; (2) license and conduct prior review of all research involving cloned embryos or for that matter all human embryos; (3) register and track each individual cloned human embryo; (4) establish a list of what may and may not be done with cloned human embryos once they're created and so on; (5) oversee corporate, academic and industrial cloning for biomedical research; (6) monitor and regulate or for that matter the buying and selling of cloned embryos and human oocytes; (7) establish guidelines — we would have to work very hard to develop language of that kind.

CHAIRMAN KASS: To be sure. In fact —

PROF. SANDEL: Mr. Chairman, I didn't want to refer to any documents because I know we don't do that —

(Laughter)

— so I simply offered seven descriptions of the regulatory regime that this Council could perfectly well adopt.

CHAIRMAN KASS: Correct.

PROF. SANDEL: And the licensing one, in particular, is the one that triggers what Rebecca called and Frank the de facto moratorium because if we say that it should be permitted only under conditions of regulation where one of the regulations, perhaps the second item in the list we would devise, says license and conduct and according to that position, the Council would be saying there shall be no research done on cloned or human embryos for that matter, except in such time they're duly licensed by a proper authority.

DR. MCHUGH: The time — excuse me, please. I just meant the time would be being spent in an appropriate, discussive way with a goal in mind and in a fashion that just a flat out moratorium would not. There would be work. There would be debate. There would be change, but there would be progress.

CHAIRMAN KASS: Let me make a small comment. I'm on the list for my own comment in a moment, but I would just simply remark on the oddity of developing this massive proposal for regulation on cloned embryos alone and —

PROF. SANDEL: Why would be restricted to that? Why couldn't we say for all embryos?

CHAIRMAN KASS: But here is how we started on a project that was really primarily interested in the question of cloning to produce children. It turned out that we ran into the embryo problem as a complication of trying to figure out what to do about that. In my view, the proper context for the discussion of the ethics and the policy about cloned embryos belongs in the embryo research question, not somehow as a little tiny piece of the cloning question, although there are people here who disagree with me because cloning is cloning. But now it would turn out that one in a way envies these other countries where they have at least, in the case of the Brits, they put everything around the embryo so it's the fertilization and embryological authority. The Canadians talk about reproduction and have put the context somewhat differently, but they at least have larger contexts in which they can plug this question. We would be trying to invent the whole thing, attached to a question of public policy connected to cloning. I'm not saying it's wrong. I'm not saying we shouldn't, but it would seem that this is part of a piece for a longer term matter, rather than something that — well, certainly as I speak I can hear the counter arguments.

PROF. SANDEL: In that case, you can offer it, Mr. Chairman.

CHAIRMAN KASS: Let me see. There are people who want to jump in the queue, but Alfonso is waiting and then I am after him. Are there small things to what's just been said because we should have it?

Gil, on the list; Rebecca; Frank. Alfonso.

PROF. GÓMEZ-LOBO: Okay, just a minor reminder here that we're already talking about regulation, but we're talking about experimentation on human beings without consent and with destruction. Now I know that immediately raises the problem, but I want to raise the problem of the moral status of the embryo. I don't think, and Frank you'll forgive me, that it's enough to say we will not come to an agreement. I don't know. You may produce arguments that are so clear that I may be convinced. I'm open to that. But I think that moral skepticism is a very serious matter. Let me just give you an example. There was a woman in Spain in the 16th Century where there was skepticism, I mean it wasn't clear of the status of Native Americans, whether they were human beings or not. And that cost thousands of lives until you had someone who decided not to be skeptical, Bartoleme Las Casas and that's very important in this case. I just cannot sit back and say look, we don't know or we can't agree. I think if anybody in this republic has to make the effort to hash it out it has to be this one.

Now I want to make an objection of that with what Bill Hurlbut was saying because I think — I see something very admirable in that and I'm not going to go back to your adjective, Mike, because it's really a bona fide effort to do this, to say look, for us the science is tremendously important. We have a tremendous trust in what is being done and although some people say it's a hype, it's an exaggeration, I'm personally willing to bet that it's very, very important and that a lot of good is going to come from it. But there is this matter of making it compatible with a very deep-rooted principle of our civilization is that you just don't kill innocent human beings for the benefit of the rest of us.

Now how can we make that compatible? Well, any exploration of that along the lines of saying well, if there's an organism that we have reason to think is not human, then that would be a solution. Then we would not have a problem. Then that would be wonderful. Whether it's feasible, whether it's an allusion, I don't know, but in a way it's a goal. It's an end. It's a way of preserving a very basic right and of course, I could go back and discuss with Frank the question of evolving rights and why I think it's an incoherent notion. I think much of it and I'm just suggesting it now, has to do with the kinds of rights and the kinds of goods we consider. Sure, your voting rights come with age, but there are other more basic rights such as the right to physical integrity that we have to respect even in a small child. So I think that there's an allusion there that because certain perhaps secondary rights have to do with our age, that that would entail at some basic rights or rights of noninterference with basic goods would be affected.

Now that's exactly the kind of discussion I would love to have.

PROF. SANDEL: Could I just ask Alfonso if that leads him, that those considerations lead you to favor a ban or a moratorium?

PROF. GÓMEZ-LOBO: I'm really flexible because the — as Mary Ann Glendon said, a ban is just a moratorium of a different sort. If a moratorium means that this is not going to be done, either destruction of early human embryos and there's going to be a chance in the country to rethink it and to have discussions, for instance, like the one I would like to have, surely that would be a favorable situation.

PROF. SANDEL: Just a quick follow-up, Alfonso. If you regard embryonic stem cell research as morally tantamount to infanticide, yanking organs out of an infant for good ends, would you also favor a moratorium rather than a ban on infanticide for that purpose?

PROF. GÓMEZ-LOBO: Well, I don't think anyone thinks — is proposing, infanticide at the moment, but there are people proposing stem cell research with destruction of the blastocysts.

CHAIRMAN KASS: Why don't you go first and I'll go next?

PROF. MEILAENDER: Yes, because what I had to say really does follow up on this in some ways. A lot of the discussion has really centered on the question of whether 3 and 6 are distinct policy options or whether in a sense, they roughly collapse and I would like to keep them separate and it seems to me that there's a good reason for that. Unless I just misunderstand what's been going on.

As I understand 3, even on the restrictive McHugh, Sandel, Fukuyama interpretation, what it means is is that the moratorium, the moratorium means that we intend to go forward with research cloning, but we need time to figure out the circumstances under which and the limits on which, on the basis of which we will go forward.

If that's what it means then that's saying that some of us really don't need to enter into that conversation any longer. The crucial question has been answered and it's over. We're not thinking about extending the conversation or trying to prolong it in order to reach better understanding or more consensus.

If what the moratorium means is we don't know whether at the end of this time we'll say yes or no to this, and during the time of the moratorium some of us will come up with model legislation for what regulation could look like and thereby stimulate discussion. Some of us will keep working on animal studies. Some of us will try to persuade people that it's a bad idea to do it, but everybody is in the conversation, so that the two different understandings of what a moratorium means are quite different in that respect. To collapse 6 into 3 is to say that really we've made what at least some people regard as a fundamental decision and they don't have anything to contribute to the conversation any longer. To leave 6 as an independent option means that everybody continues to be a contributor to the argument, or so it seems to me anyway.

CHAIRMAN KASS: That certainly and I'm glad you went first, because that certainly is part of why I think that Option 6 is the preferable option for us at this time.

My own thinking goes something like this, it's partly informed by principle. It's partly informed by the fact that there is this deep disagreement, and it is modestly informed by my concern that once again we will not be able to do anything at all on the thing I care most about, namely a ban on cloning for reproduction because of the continued division over this other matter which divides us.

Let me see if I can put together certain things which I would stipulate as, if I say they're facts, I'm only going to raise the flag and someone will shoot them down, but let me call them assumptions, close enough to the facts. First of all, Council is unanimous in opposing cloning to produce children as far as I know. I don't have any dissenters from that. Maybe some are for it only temporarily, maybe they wouldn't want a moratorium on it. Maybe some would want a ban, but that's number one.

Number two, the Council has been of many minds on the question of cloning for biomedical research and don't simply divide neatly into those who approve it and those who disapprove it, not only because of whether we approve with enthusiasm or approve with concern, but there are even some people who might approve the research, but who might not be willing to approve it just yet either because of the absence of a regulatory scheme or because they think there might be at the moment lack of sufficient evidence to sustain the claims for the unique value of cloning for biomedical research or because they are concerned to ride roughshod over the powerfully held opinions of colleagues in the absence of sufficient evidence. So there are a variety of positions out there. And of the people who declare themselves in opposition, some will do so because they will always be in opposition unless Bill Hurlbut's proposal or something like it could be met and others are opposed to — would be in favor of a ban or oppose it because even if they don't hold the embryo to be inviolate, they worry about, and this I think is Charles' position, they worry about us starting down the course of treating nascent human life as a natural resource for the benefit of others with what some people call the "slippery slope" but what Bill Hurlbut has called establishing a principle that our subsequent practice will merely catch up with once it turns out that going further is even better for Paul McHugh's patients.

And then there are finally some people and I include myself among them, who are worried about permitting cloning for biomedical research because they're concerned also that once the embryos are available there, it will be much more difficult to in the absence of regulation to certainly police what's done with them and there's a slightly greater risk how much is an empirical question, but I don't want to find out that this will lead to cloning to produce children.

That, I think, is an accurate assessment of where the Council has been. I would note another thing that figures into my consideration is the great uncertainty about the research, not just with cloned embryos and clones, but even with stem cells all together, embryonic adult, we just don't know. Everybody has said that and it's agreed.

And there's no question, I think all of us have seen the promising benefits of this research though it's still too early to tell.

These uncertainties cut sort of in two directions. I mean on the one hand, Paul McHugh has said several times they ought to temper something of the immodest claims that the miracles are just around the corner and they place a very high — they should place a certain kind of higher demand on the cautious accumulation of evidence and yet they should also temper people with their equally immodest assertions that we can know in advance that there will be a morally nonproblematic way of doing what needs to be done. I mean the uncertainty question, it seems to me, goes in both directions and doesn't settle anything but it should make us very, very modest, I think, about what it is we do.

Next point I think which is very important and doesn't show up in the question of federal funding. Legal proposals to ban cloning for producing children which then tacitly and then in some cases even explicitly would allow cloning for biomedical research would be different from simply allowing it without legislation at all for this reason. You would have the official legislative endorsement of crossing this boundary, of creating embryos solely for research. To this point, we don't have this. It's not illegal, the private sector can do it. We have federal funding of the stem lines, but we do not have — we have no official government policy which says it is all right to cross this boundary and we would do so explicitly and officially, approve crossing this boundary, a boundary that the previous federal advisory body, including the NBAC, said should not be crossed at least not with official government sanction. See, that's an important political step. Whatever you think about — wherever you come out, that's a statement of our whole community.

Last point, I think that's also a fact. You may not value the fact very much, but it is a fact. And the other fact that's important to me is having watched now in 1998 and again in the present time, seeing the Congress struggle to try to enact a ban on cloning to produce children and with what looks like very likely a failure once again, a failure that nearly everybody supports and we might be overtaken by events, a failure that is the result of the fact that we have a standoff between and I say this without meaning to disparage, the zealous proponents of biomedical research and the zealous opponents of any research that destroys cloned or any other kind of human embryos. And zeal, I mean to be a praiseworthy term. There are moral goods here that are being passionately defended. That, I take it, is our situation.

How to solve the situation, assuming you want to get passed this impasse at the very end which is very important to me. Let's get an agreement on what it is there is an agreement on which is a ban on cloning that would produce children. Let us recognize, let us get us a little extra insurance in the absence of regulation by not allowing the cloned embryos to be produced period. And let's have time for the following important public reasons. Several of them have been said. One is the question to get a little extra research so that the scientific case could be made more compelling so that it isn't just the promise, but we've got models with cloned embryos in animals where you've actually produced some kind of therapeutic value. Or let's show that — we can spell it out. I don't want to spin out the scientific possibilities.

There would be time and there would be an incentive to develop the regulatory mechanisms if one of the reasons for the moratorium was explicitly to say to those people, you want to do it? Go out there and devise the — go out and devise those regulations that would be able to persuade people that you could lift this moratorium without really running grave risks of any of the harms that people want.

We haven't had really, there's been an interesting debate. We don't normally have these things and unless you think it's just deplorable that the country should try to decide about these things — I don't mean we here, I think we've done pretty well, but it's been interesting to see the nation struggle over this little tiny question, but to wrestle with things that really are about terribly important things, but it hasn't been conducted all together on the highest level. You don't somehow really try to win the moral argument, either by having the Bishop threaten the candidate in Missouri or rolling out Christopher Reeve and Michael J. Fox in the Senate and have that serve in place really of a deliberation about where the boundaries should be. It seems to me that with — that the argument can continue and if you got the reproductive cloning issue off the table, that ban stays in place. Then the argument would have to be thought out where it really is. You couldn't somehow use people's disgust over cloning to produce children to try to try to smuggle through the back door a ban on some embryo research. And you couldn't — and you would have to take up the embryo research question two part, and then try to figure out what's the right way in this country to regulate embryo research across the board and not sort of fight it all out over this little tiny matter.

It also seems to me and here I make this appeal to the scientists. You might think I'm wrong, there are cowboys out there and there are disasters that are in the making and it seems to me that a moratorium that was undertaken not just as a stop gap measure, but as an invitation to the scientific and technological community come forward, join the process, help the community design those kinds of boundaries and standards that we all would be willing to live by, it seems to me the scientific community could only gain an increased trust and support of the nation as a whole.

If I really thought, I mean, if I really thought that we really were turning down the manna from heaven tomorrow or the next couple of years in cloned stem cell, cloned embryo research, I might have more hesitancy, Paul, but I really have the feeling that at the moment, I mean it's uncomfortable to say that any kind of scientific research would be banned and it makes me uncomfortable notwithstanding what you might suspect of me. It makes me uncomfortable and I don't like the jail time. I mean I would never — but it seems to me to ride roughshod over this moral boundary on a mere promise of the absence of the evidence when so many of our fellow citizens would be offended by this, I think it calls for a delay affirmatively, not as some kind of fall back measure. We simply — we don't have a consensus on this and the question is how can we move toward getting — we may never get a consensus, but we can at least have this argument prolonged on a higher level, perhaps even stimulated by something of the way in which we would contribute to that discussion.

I don't think that's a mere compromise. I think that's to somehow dignify what this debate is about and to try to let it go forward without undue sacrifice and in fact, really inviting the scientific community to come forward and say look, you're right, you've raised certain kinds of moral hazards for us. We respect that. We'll help design ways in which those things can be respected without crippling our research.

Now — sorry for — I think it was semi-coherent. I've been worrying this for months. There was a line — was I last? I guess I'm last, so Michael Sandel and Michael Gazzaniga.

Excuse me, oh, there was Rebecca. I'm sorry. So eager was I to speak I didn't write her name down. I'm sorry. Please.

PROF. DRESSER: Well, I'm not sure I want to follow that, but it was very rich. Just a couple, a few comments. I agree with you, certainly on the uncertainty, I agree with you. And I agree with you that this is really a broader issue in terms of embryo research in general and it would be certainly intellectually more appropriate to tackle the whole question. So I know I've heard some discussion. I don't know whether this Council is going to take on that topic in the near future, but it sounds as though we might. So one way to address that would be to say something, if we were — if the people who wanted to endorse some version of 3 were to say the regulatory principles and procedures appropriate to such a regulatory system applicable to biomedical research cloning would also be relevant to the general question of the use in embryo research and so — of embryos in research, generally, and so really in order to move forward with 3, we have to think through what the process and procedures, in general, ought to be and then we could start working on our thoughts about that.

Another point, I guess another reason why I have more difficulty seeing differences between 3 and 6 is because for me, at least, a regulatory system does not have to be very permissive, that is, I could imagine a regulatory system that would have a process and principles in place that were extremely demanding and would demand an exceptionally compelling showing of necessity before something would be allowed to go forward and a showing that would have to be accepted by people not only from the scientific community, but from a broader group of people. So I could see — and this, I guess, leads me to my last point which is in some ways I think you're talking about the work that could go on during a moratorium is very similar to what some of us would think about the work that could go on during a process of thinking about what a regulatory system would look like which would involve scientists talking with other people in the community to figure out what kinds of principles would work, what kinds of a showing would be acceptable, a lot of these details that we've been struggling with a little bit today. So in some ways it just sounds as though your thoughts about a moratorium would also include some of this process going on informally that some of us are thinking about well, if we took 3, then there would be some process of proposal, notice and comment, public discussion, probably revised proposal, you know, on-going in a more official way. So whether it would be informal or formal, might be more the difference.

CHAIRMAN KASS: Good. Thank you. I have the two Michaels and Mary Ann. Charles, we haven't heard from at all. Let's just go in order. Mike Gazzaniga and then Michael Sandel and then —

DR. GAZZANIGA: We're all sort of just weighing in here. The rationale that I would follow would be pretty much what Liz said this morning and maybe to add a little flavor to it to go to your Option 2 and not that I would do that, but that by during the establishment of the regulations not to have any police around which would be a way of social engineering to get the regulators to work fast and get their job done, in other words, I don't know — I just wouldn't know how one would recommend, with regulation, and then put various specific moratoriums out on activity.

But I do want to just say one last thing. And remind the Council why I think the scientists here are so clear about this and the reason is that we know and everyone knows if they think about it, the most and I've said this before, the most conservative group of people in this room are scientists — maybe not the scientists, but science. It moves slowly. It checks. It double checks. It's out in the open. It will be the thing that moves this question along and you have to start because it's slow in its activities and in how it actually establishes truth. So I think you can have policy discussions, philosophical discussions, ethical discussions for 10 years on this, why not? They're tough questions, but if you don't let the science go forward it will be in a factual vacuum.

CHAIRMAN KASS: Michael Sandel, Mary Ann and Charles, and Frank.

PROF. SANDEL: Well, Leon, you asked whether your statement was coherent. I would say more than coherent, it was an eloquent statement of the case for the moratorium/ban which however one wants to describe it, it's been articulated here today. Some of the defenders of the moratorium define it as more or less interchangeable with the ban that Mary Ann and Gil and Alfonso and Leon, you made a strong case for at least some version of a moratorium which in this discussion today has essentially become merged with the ban and I think it's a powerful statement and set of considerations.

I would just like to address two of them. One is that you feel it would have the moratorium/ban would take the reproductive cloning issue on which there's wide agreement off the table and so it wouldn't muddle the other discussion. But that seems to me true of all of the proposals we're considering. All of the proposals, policy proposals would ban the reproductive cloning and therefore take it off the table. And so that's not uniquely true of the moratorium/ban.

The second thing I'd like to address is a point that you raised, Leon, and that Mary Ann and Gil and Alfonso raised, the idea that a moratorium would allow the moral argument to continue. I think it's very important that the moral argument continue and that the moral/policy argument continue. I think it's a mistake to assume that any of these proposals would prevent that argument from continuing. I think the reason we are tempted to think that a policy decision of one kind or another would somehow prevent public discourse in wrestling with these moral questions including the moral status of the embryo which I think should be preserved as a live argument and debate in public discourse, regardless of what policies are recommended or enacted. The reason I think that we — people fear rightly the danger of kind of shoving off the public agenda that question or related questions is what happened with the abortion debate, but there's a big difference. The abortion debate — the Supreme Court decision did contribute, it seems to me, to taking off, out of public deliberation the question about abortion and the moral status of the embryo, precisely because it took that decision out of the legislative arena, out of the democratic arena, but nothing — we are not a Supreme Court and if there is a decision taken, a recommendation by this Council, enacted into law by the Congress or by some state legislature, the debate is still open in a democratic society as all such debates are open and should be open. So we're not facing a question here of a Supreme Court ruling that's going to say no, there can be no more democratic deliberation about this question, forget about it except for journal articles and philosophy journals. This will still be and should be the subject of continuing discussion including on the most fundamental of the moral questions that we've discussed here.

I think the question we should ask ourselves is not are we by one policy recommendation or another going to suddenly prevent public debate on this question. I think we should ask ourselves how can we frame the alternatives that have developed over this 6-month period in a way that not only will permit, but will give focus and structure and maybe inspiration to continued public debate about these ethical issues.

I think that we sell ourselves short, if we think that offering two major policy options, some favoring one, others the second, whether it's called the moratorium or a ban, developing the reasons as we've developed the ethical arguments and the various sides, that in itself, would be not only a contribution, but it would be a way of giving focus and inspiration and animation to a continued public debate on this question. We're not the Supreme Court.. We're not foreclosing. Whatever of these we choose or whatever pair of them, we recommend, we're not going to be foreclosing public debate on these moral questions and shouldn't. The question is how can we give it structure and focus and I think listening to the comments this morning and today, we're basically there. We basically, I think, have thrashed it out to their two clear positions and people have developed — have defended the two positions broadly speaking, whether you want to call the second a moratorium or a ban, that can be up to the final drafting, but I think that we've really identified the major alternatives, both ethically and in terms of policy and I don't think we should underestimate the public service that that constitutes.

CHAIRMAN KASS: I have Mary Ann, Charles and Frank, in that order. Please.

PROF. GLENDON: As I recall, the reason that we took up cloning was not because —

CHAIRMAN KASS: I wish somebody could remember.

PROF. GLENDON: Not because there was any logic to it, but rather that because there was pending legislation and we were asked or thought it was a good idea to address ourselves to that problem because it was so current.

But especially listening to the discussions this morning of how other commissions and other countries have approached these issues, and listening to the discussion this afternoon, it seems to me that maybe where we are is that we're ready to make a policy recommendation on cloning for reproductive purposes, but the second matter, cloning for research purposes really, logically belongs within the general question of embryonic research which other countries and other commissions have taken up systematically. So I guess what — thinking out loud and maybe this is zany, but it seems to me that maybe what this Commission ought to do is unlink the policy recommendation about reproductive cloning from the more complex issue of embryonic research of which cloning for medical research purposes is a sub-issue and take that up systematically.

CHAIRMAN KASS: Can I just — boy, would I love to do that, but I don't think one can make — I don't think — well, I mean you could say look, we make a recommendation that we would like to see cloning for producing children banned and the world will not because even the National Academy of Sciences thinks that. So — but then you sit down and try to give effect to that and you can't do it without trampling on this other tirade. If we could do it, fine. Part of the reason I think — part of the reason for wanting to have some time where you don't explicitly give permission for that to go ahead, not just that it doesn't go ahead, but that you've sort of explicitly sanctioned it by law, that's one of the advantages, it seems to me, for the moratorium, so that the next time the question comes up, the no baby making part is there and this could then be dealt with in the context where I think it properly — I absolutely am sympathetic, but if we're asked to make a recommendation that actually could have — could be implemented, we're in the soup. That's the real — Robby, George and I, 18 months ago because we started in different places, had an agreement that we would sit down and try to draft legislation that was like Item 2, absolutely silent on the other question. Write a legislation that would just ban cloning for baby making and didn't say a peep, one way or the other, didn't imply anything about the other. I mean better people — in fact, I even asked Michael Sandel if he had had a shot at it, because I thought he thought it was a preferable — I don't know if you tried. It's very hard.

I'm sorry, I've abused the privilege of the chair. I wish we could do that. I don't think we can make a responsible policy recommendation and simply say this other thing isn't here. It's attached to this like a barnacle.

PROF. GLENDON: Can I?

CHAIRMAN KASS: Please.

PROF. GLENDON: I wasn't suggesting that we say the other thing isn't there, but that this Committee should take the time to systematically —

CHAIRMAN KASS: I see. Forgive me.

PROF. GLENDON: — View the second issue within its proper context of embryonic research.

CHAIRMAN KASS: I see and therefore not have a full policy recommendation.

PROF. GLENDON: And make a policy recommendation later.

DR. KRAUTHAMMER: But Mary Ann —

CHAIRMAN KASS: You have the floor, actually, Charles.

DR. KRAUTHAMMER: Yes. If we were designing a seminar on the question of embryo research we may not have chosen in advance that cloning be the entry point, but in fact, it has been the entry point just by historical accident, if you like and I think that, in fact, if you look at all of the documents that have been produced in all of our discussion, we have done a pretty thorough investigation of the issue of embryo research, even though it focused on the cloning aspect.

I think it would be a pity to throw away everything that we've done which is quite extensive, I think, quite remarkable. I've looked at the documents that were produced. I think there are major contributions to the national debate and I think we ought to — given that we have spent all this time and gone deep into the issue, both the science and the ethics of it, I think it would be a mistake not to go to the next logical step which is to issue a recommendation on the basis of what we've said. I'm sorry, I missed the discussion this morning, I was out of town and I — perhaps I'm stepping back here, but I just want to step what my position is on the question and that is, as you know, I oppose research cloning really on two bases: (a) I think it crosses a new moral frontier which is the creation of a nascent human life for its exploitation and use by others; and secondly, because I distrust and this is just based on experience and observation of what happens in Washington when with the regulation I distrust our ability to establish a new line, a line that will hold.

But these are both credentialed judgments and they are subject to review, given new facts and new history that we will be creating in the future. So I would come out at position 5 where I would prefer a ban on both, but I could live with 6 which would be a ban, plus a moratorium. I see the difference. You probably have had this discussion. I'm sorry that I'm late. I'm probably repeating it, but in a democratic society obviously all bans are temporarily. They can all be reconsidered, so that the difference between a ban and a moratorium is simply that when we do inevitably reconsider this issue, a ban means the burden of proof is on those who want to undo it and a moratorium means that the burden of proof will be on those who want to institute a ban. And as a proponent of the ban, I'd be quite willing, happy, to restate, refight the fight in the future, if necessary. So I would be for 6.

CHAIRMAN KASS: Frank.

PROF. FUKUYAMA: Well, just one last comment on why I prefer 3. Gil was saying that 3 made the decision in principle in favor of embryo cloning and therefore in a way it foreclosed that discussion. I understand that point, but I think that you need to consider the question of whether 6 may not actually lead to the same result faster because it's one thing if you assume — okay, we have a two to three-year moratorium. Either people are convinced by Alfonso and Robby about the moral status questions which I think there's close to zero probability of, or adult stem cells or some other approach seems very promising and the embryonic stem cells seem less promising which may also happen, but there's also the possibility that after that period of time the embryonic stem cell research from animal studies or from other countries will seem so promising that in fact, once the moratorium expires you will go right into unregulated embryonic cloning. I mean that that pressure — the moratorium period will be used to build pressure for that. And at that point, you're going to have the cloning and you won't have a regulatory structure in place. And so that seems to me a risk that you have to consider if you go for number 6.

Now on Leon's point that it seems a little strange to want to create this huge new regulatory structure just to deal with the cloning issue, I actually regard that as an opportunity because I actually think that there are many issues out there much more important than cloning that will need a regulatory structure: pre-implantation, genetic diagnosis, you know, germ line, when we get to it, creation of hybrids, I mean, all the things, issues that these other agencies deal with that we ought to be as a Council thinking about where we don't have rules, where we don't have an institution capable of dealing with that and so I welcome the fact that this gives us a good excuse to actually set this kind of institution up or think seriously about what such an institution would look like.

Charles, a couple of years ago wrote this article where he said about stem cells that people ought to be more worried about where the stem cells are going, rather than where they came from and I think that's absolutely right. I mean it's where they're going that creates, for me, all of the really frightening possibilities. And for that, you are going to need a broad-based regulatory institution that will not hold back therapeutic technologies, but will put some kind of long-term societal control on ethically questionable things that go way beyond this particular embryo cloning thing. So I would say the issue is not just embryo research, it's embryo in general and new biotechnologies, in general. Because I think, for example, if you looked under this rock of the American IVF industry, you'll find exactly the same sort of things that Patricia Baird found when the Canadians looked under their IVF industry, that there's a lot of stuff that is going on that doesn't get a lot of attention, but really probably needs further regulation. So all of those are issues that are tangential to cloning, but I think we need to address, so that's why I think that number 6 is actually a good excuse to get us into this.

CHAIRMAN KASS: You meant 3, right?

PROF. FUKUYAMA: I'm sorry, 3 is a good excuse to get us into this.

CHAIRMAN KASS: The only thing I would say and — yes, please. Are you going to respond? The only thing I would say is that the general sort of political economic climate in this country is not Canada and that is to say, the ease of doing something like what they've done there given our absence of bureaucracy and the laissez-faire attitude in the industry is — means that one shouldn't be too sanguine about how easy it — we can sit here and recommend whatever regulatory agency you'd like, but if you think that — if you saw how unhappy the industry that had basically not much interest in cloning for biomedical research was about this, wait until you see what happens when you sort of threaten the whole activity in which they're engaged because to do this thing right, you're not just interested in dealing with the area of federal funding. I mean if you really want regulation, you want it across the board, and let's not be naive about how — it's very easy to kill legislation in this town. It's very hard to pass it and especially something which goes against the grain of the leading zealots for doing these things.

PROF. SANDEL: Was that also zealot in the complimentary sense?

CHAIRMAN KASS: Yes, yes. Dan, I'm sorry.

DR. FOSTER: I think I would just like to say that I will support position 3 and having heard your very eloquent presentation including at lunch when we talked privately, the key issue for me has to do with the inviolability of the embryo. If you believe that, then you have to say no cloning at all. You simply have to say that. This is the same thing as destroying or sacrificing a human. You have to say that. I don't hold that view. I don't even know what the evidence is for that view. I mean this is in that broad space between — that Russell talked about, this no man's land. People can say what they think it is, and one follows the logic of the reasoning and see whether it's valid or not. So that's out.

I think that — I once gave a speech where there was an argument and I ended with a confession of faith, not a religious faith, but you might claim that I'm making a religious faith. I said I thought it was an argument about whether science should exist in medical education and so forth that I thought that in the end science would win and that is because you cannot squelch truth ultimately.

I have a high confidence in what has already been said in the practicality of the scientific communities, sometimes even in the biotechnology community. And that is I do think that they're cautious and things that don't work quickly get dropped. In the first place, they can't get published and secondly, they don't work. Even with such a hopeful thing in the treatment of cancer as the angiostatin, you know, the stuff as Bill was talking about to stop the growth of blood vessels to stop — stuff to cure cancer, I think it was $35 million to the rights of that that a biotech company paid. They dropped it like a hot cake because it didn't work. Even a biotech company dropped it like a hot cake.

I don't think that the new evidence that we need to make a decision after a moratorium of three years or six years or 10 years can be forthcoming without the kind of comparative investigation that several of us spoke about this morning. Scientists do not wish to look at things in isolation. They look to the whole truth. They would like to look to the whole truth, whether stem cells, adult stem cells are better or cloned stem cells and so forth. And to put a moratorium on this simply begs the question of the information that one wishes to make. We have all the information we need to make a moral decision. I mean because the arguments have been made ad nauseam. If I've heard one time that we were once an embryo, I must have heard it even in the course of this conversation multiple times. The argument is almost always the same. The same people, different people speak, but it's the same message. So I think that we ought to just have — we ought to just vote for what we think.

I said in a very short public statement in an e-mail that if I was convinced that this was an inviolable thing, I would be with Gil or whoever. I wouldn't do it, no matter what the promise was. But I happen not to think that's true and therefore for not only individual patients, but for humanity itself and so forth, I think we ought to let the facts that science gives us tell us what to do.

Now do I think this ought to be regulated? Yes, I do. And how long it takes to do that, I don't know. And maybe we'll just say that the American scientists will wait for the English scientists to do this, but in one sense, I don't want this to sound wrong, but in one sense I have confidence in the — maybe because the society in which we live more confidence in the caution of the scientific investigation with American scientists who are influenced by all the moral issues that we've talked about here, about making these judgments as well. That was almost never talked — but I did want to say the reasons why I think we ought to go ahead and we ought to do it in terms of what we think the embryo is and what we think the risks, is this a line? Leon thinks this is a bright line that we're making life and then killing life. Do we believe that? Then I don't even know why you want to do a moratorium. If you believe that, then you ought to just have a permanent ban and try to defend yourself.

But it is my confession of faith that finally you cannot stop what biological or other truth is and we have to simply see if these things work and I would like it much better if we could work on it and get the answers and if it doesn't work, let's get on to Bill's view or something else along those lines.

DR. KRAUTHAMMER: Dan, if I could just make one point. For some of us, the reason that we oppose this is not because we see a bright line between life and nonlife and creation and believe it's the destruction of a person. And our concerns are rather different. They're about the possibilities of what this research could lead to. So I just want to clarify that it's not — this is not a debate, if you like, a recapitulation of the abortion debate. For some of us, it's a debate about what might eventuate, rather than say origins of the cell.

DR. FOSTER: Well, thanks for that clarification. I know that you feel that way. You've told me that previously.

I think that the issue that we worry about would be the one that it would make it much easier to make human beings for rogue scientists or other scientists to do that and that's a — there are evil people around and there are things like that will happen. I somehow think at least in the developed countries, maybe that doesn't — that that would be — I mean there's such a universal — some people have used the term here revulsion against that, a revulsion which I hold, I might add, that it would not — that that would be easier to police and to prevent than — you know, than maybe what you think it would be. I don't know.

DR. KRAUTHAMMER: What I worry about is not what the rogue scientists will do, it's what the good scientists, the good society will allow itself to do.

CHAIRMAN KASS: Robby George, we're going to wind up very soon. If there are any people who want to add something before a break, Robby, a comment?

DR. GEORGE: Yes. Dan, I appreciate the frustration of hearing the same argument from the same people, time and time again, and particularly, the point that the being that is now you or me was at the earliest stage of his existence an embryo. And we have heard it time and time again. But I don't think I've heard the counter argument to that. The point of the assertion is the claim that we have our inviolability and our dignity by virtue of the kind of entity we are, rather than by virtue of some acquired characteristic that may or may not come with fuller development and which different people have in different degree. I think it's therefore incumbent on people who take the position that the embryo is not inviolable, is not fully one of us to say what it is then or to say in virtue of what it is that those human beings who have inviolability and dignity, who have achieved whatever it is you need to achieve to have inviolability and dignity have. That — Michael Gazzaniga, I think, has put something on the table with brain development and there has been an exchange about that and if that's the general position, then at least we know what the argument is, but I don't think it's enough simply to say I don't accept the claim that the embryo is inviolable. I think if you're going to reject that claim, given that reasons have been advanced for the claim, it is incumbent to say in virtue of what then, if it's not the kind of entity we are that gives us our inviolability, in virtue of what it is that we have our inviolability. Because if people on my side of this debate knew that, what it was, then either we'd be persuaded by it or we could give our reasons for why that — as far as we can see, doesn't work.

DR. FOSTER: Sure and I know we have to quit and I respect the argument. I would say that I would put myself in a position that I'm agnostic because I don't know how to answer that question and you tease me a little bit about bringing in the issue of the soul. I was just repeating an old story from the Bible and saying at least the person who wrote it, that the soul came in later. That's all I meant. I didn't mean that I — I wasn't trying to introduce a revelation in here. I carefully said that I didn't know who wrote this and that it was old, but it was very interesting that it was into the intact human that God breathed life and that the human became a living soul and it's just a story from Genesis. That's all I meant by that.

So the reason that I don't — it doesn't make sense to me and I really followed at some point I wrote a little short paragraph about that that along the lines that this was a potential human being incapable of doing, becoming life itself because it wasn't implanted or anything else. It had no organ, no brain neuron, it had no sentience at all and as a consequence, common sense, just mere common sense said to me that biologically at least, this was pre-human and not human and as a consequence I did not think that it had the same inviolability that I might make at the time 40 days later. I don't know what the time is, but let's say 40 days or whatever, which I would move away.

But I speak of this in an agnostic position and one of the things that concerns me so much is the absolute certainty that some people have that they can do that. I'm not speaking about — I'm sure you're probably worried about this as much as I am, but some people are absolutely certain that the moment — we've heard this expressed here, that the moment that the sperm hits the egg, that that is inviolable.

Now I heard Bill quoted this — when Gil and I were talking a little bit later about the estimate that every year, if you just look at a one to one loss — if for every child born, there's one that's not born. It's not implanted, and I was telling him that the World Health Organization says that there are — they estimate that there are 363,000 babies born every day, 100,000 deaths, so that means that nature in one year, I know these figures may be soft, eliminate 130,495,000 human things. And so Gil said well, Bill thought that they were not complete. I hadn't seen this argument. They were not completely fertilized or something like that, but my point is here that one has to be agnostic about this and that's all I'm trying to say.

DR. GEORGE: But I don't think you have to be agnostic about what it is in virtue of which human beings have inviolability. That's what I'd really like to know. If it's not by virtue of the kind of entity they are, that is, an entity with a rational nature, then what is it? Is it sentience? Is it brain wave function? Is it the realized capacity for self-consciousness or self-awareness as my colleague Peter Singer says. I'd just like to know what argument it is I'm supposed to answer.

DR. FOSTER: Well, I say I can't answer it because I don't know and I don't — I'm further trying to say that I'm not sure that any human knows the answer to the question that you wanted to — I can decide — I mean I might decide at the time there's the first — because you can't — the highest organ system, as far as I understand it as a physician scientist is the central nervous system, the body will try to protect that against all odds and secondarily, it supports the circulatory system in order to protect the central nervous system. So if you've pushed me, I would say it's at the point where one had the capacity to sustain life with an organized or the beginning organization of a central nervous system because without that, there will be no progression under any circumstance of this organism to a full human and these are simple arguments.

DR. GEORGE: I know, but I think we're actually getting somewhere. So if the reason we don't look at just an individual innocent person on the street, and say gee, that's one person, it's a good thing that there's one person, but we've got 26 or 27 people in hospitals waiting for organs, so with that one person's organs, counting two kidneys, one heart, one pancreas, one liver, etcetera, we could save 26 or 27 people. The reason we don't do that is because that innocent individual like all other innocent individuals has inviolability and he has this inviolability by virtue of having a central nervous system?

DR. FOSTER: No, his inviolability is much more than that. You're asking, I think, at the embryonic level where I would make this decision.

DR. GEORGE: No. I'm just asking for any human being you think who's there, the human being has got there, by virtue of what does he have —

DR. FOSTER: Mr. Chairman, rescue me here. I do not wish to be a — I need to be rescued. All I was trying to say is I was voting for Proposition 3. That's all.

CHAIRMAN KASS: I'm going to rescue —

DR. KRAUTHAMMER: We need to discuss this.

DR. FOSTER: Not here and not now.

CHAIRMAN KASS: Look, if I could ever overcome my new phobia of all conversations about embryos which is the result of all of this discussion, I would at some point down the road after all of this is behind us, it's occurred to me, it's occurred to me that we could make a useful contribution, separate from any public policy question at all. In other words, get it out of the argument to actually have — get some embryologists in here, get some philosophical biologists, people whose field is the philosophy of biology and maybe have a conversation about this with some presented papers, rather than continue to — the conversation has to go on and it's obvious it's not the only thing here. I don't agree with that that it's the only issue. I think Charles has and Dan has conceded that.

This isn't, I think, the place to do that. I would recommend that the two of you have dinner together and report the —

DR. FOSTER: I already acknowledge defeat, Charles.

CHAIRMAN KASS: But it seems to me if I may on Dan's behalf say to you, Robby, since Jim Wilson has, in a way, spoken for many of the people on the — I shouldn't take his name in vain because he's absent. I think he's still out of the country. He tried to make a kind of moral intuition argument which doesn't settle anything as people who talk about the wisdom of repugnance know all too well, but that argument can embarrass intuition or say maybe your intuitions are senseless or wrong, that's a nice ploy, but when you finish arguing with him, you tell me why your moral intuition that cannibalism and incest are abominations? You give me an argument that's adequate to that. Not now.

(Laughter.)

DR. GEORGE: Can I just cite an article I've written?


SESSION 4: PUBLIC COMMENTS

CHAIRMAN KASS: No. Here's where we are. We had scheduled time here for a break before the public comment. It turns out that having rearranged the schedule so that there would actually be a quorum when the public comment session was called, no one signed up to make public comment.

Now that doesn't mean that there aren't people out there who would like to make it, but in the absence of a list, I'd like to gamble that rather than break and make people come back, that we rather ask anybody who has public comment to make, the rules here are 5 minutes or less, to come to the microphone and we will sit here now and then adjourn early if that's agreeable with everybody.

Is there anyone, any members of the public who would like to raise questions or offer a comment?

No obligation, but please feel welcome. Unlike the people in Canada, we haven't gone around the country and talked to 40,000 people. We wait for them to come here. It's probably improper. Does anyone want to comment?

(Pause.)

Well, then let me sum up where I think we are which is hard to do. It sounds to me like there are — there is some coalescence around a couple of positions. What the more restrictive position would be, number 6 or number 7 or whether there would be, whether people would want to file separate opinions on that, that's to be worked out, but not here. I take it that the less restrictive or the more liberal position would coalesce around Option 3 and as Michael Sandel has astutely noted, the materials for what might go into a description of that position have already been thought through.

I don't know how rapidly we can move to the conclusion of all of this. I don't mean today, but maybe we'll have something to report to you by tomorrow once we can talk to staff right now after this meeting and see where we are. But I think we've made a lot of progress, at least — I think we could make this a lot better if we took another six months, but I'm not sure the marginal rate of improvement is worth it and to the extent to which the issues that still divides us really is part of the stem cell discussion which we will have to have any how. I propose that we proceed here and try to bring this to a conclusion with some recommendations on public policy, assuming that there is not yet an explosion to occur about which I don't yet know.

Is that — if there are dissents from that, rough sense of the meeting and people will get an opportunity in due course when these positions are drafted to both — in fact, maybe I'll speak with you, Michael, about some help on that or Frank. But people can get a chance to sign their names so that you will be with your friends. We will not — I'm happy that there's more than one recommendation coming out of here. It seems to me what the conversation warranted. And we serve people best, I think, if we show them two morally serious and well defended and articulated positions and in which they can actually see the price of choosing one or the price of choosing the other because this is not an area where there is something cost free to be had.

An announcement. I realize that we asked you to save time for dinner, but there was perhaps not all together a follow up on where that will be. Council Members will meet for drinks before dinner at 6:30 in the hotel bar, it's the main lobby at the top of the stairs. And dinner is at 7 in the Washington Room which is the room where we have had our — the breakfast room. It's I think that way and around the corner. The signs point to the Washington Room is on this floor.

The meeting is adjourned until tomorrow morning at 8:30. We will have a session, two sessions on patenting and I remind you that there is a new submission in the materials here from Professor Arti Rai, her paper on patenting of living organisms.

Thank you for your attention and comments.

(Whereupon, at 4:06 p.m., the meeting was adjourned, to reconvene tomorrow morning, Friday, June 21, 2002, at 8:30 a.m.)




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