UNITED STATES OF AMERICA

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THE PRESIDENT\'S COUNCIL ON BIOETHICS

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FOURTH MEETING

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THURSDAY,

JUNE 20, 2002

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The Council met in Ballroom Salon I, Ritz-Carlton, 1150 22nd Street,
N.W., Washington, D.C., at 9:00 a.m., Dr. Leon R. Kass, Chairman,
presiding.

[PRESENT]{.underline}:

LEON R. KASS, M.D., Ph.D., Chairman

ELIZABETH H. BLACKBURN, Ph.D.

REBECCA S. DRESSER, J.D.

DANIEL W. FOSTER, M.D.

FRANCIS FUKUYAMA, Ph.D.

MICHAEL S. GAZZANIGA, Ph.D.

ROBERT P. GEORGE, D.Phil., J.D.

MARY ANN GLENDON, J.D.

ALFONSO GOMEZ-LOBO, Ph.D.

WILLIAM B. HURLBUT, M.D.

CHARLES KRAUTHAMMER, M.D.

This transcript has not been edited or corrected, but rather appears as
received from the commercial transcribing service. Accordingly, the
President\'s Council on Bioethics makes no representation as to its
accuracy.

[PRESENT (Continued)]{.underline}:

WILLIAM F. MAY, Ph.D.

PAUL McHUGH, M.D.

GILBERT C. MEILAENDER, JR., Ph.D.

JANET D. ROWLEY, M.D., D.Sc.

MICHAEL J. SANDEL, D.Phil.

C-O-N-T-E-N-T-S

Introduction 4

Session 1: Regulation 2: Genetic and Reproductive

Technologies: International Models

Lori Knowles, The Hastings Center 8

Dr. Patricia Baird, former Chair 33

Canadian Royal Commission on New

Reproductive Technologies

Session 2: Human Cloning 11: Public Policy

Options 88

Session 3: Human Cloning 12: Public Policy

Options 147

Session 4: Public Comments 225

Adjournment 228

P-R-O-C-E-E-D-I-N-G-S

(9:02 a.m.)

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.

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]{.underline} 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]{.underline}.. 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]{.underline}
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]{.underline} 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]{.underline},
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]{.underline}, 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.

DR. GOMEZ-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 Gomez-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.)

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]{.underline} 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.

PROF. 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.

DR. GOMEZ-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.

PROF. 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]{.underline} 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]{.underline} 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]{.underline} 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?

PROF. 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 \--

PROF. BLACKBURN: Oh, Leon, before that, there\'s much [in
vitro]{.underline} work that could be done before ‑-

CHAIRMAN KASS: I\'m not talking about therapy. I\'m talking about \--

PROF. BLACKBURN: Okay. Sorry.

CHAIRMAN KASS: \-- I\'m talking about \--

PROF. BLACKBURN: You mean only on cloned embryos.

CHAIRMAN KASS: Yes. I\'m sorry.

PROF. 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]{.underline} \-- 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.

PROF. 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]{.underline}?

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?

PROF. 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.

PROF. 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.

PROF. 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 \--

PROF. 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.

PROF. 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.

PROF. 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]{.underline} 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.

PROF. BLACKBURN: Sorry. What was rejected?

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

PROF. 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]{.underline}, 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]{.underline} 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]{.underline} 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.)

A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N

(2:06 p.m.)

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?

PROF. 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?

PROF. 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.

PROF. 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.

PROF. 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.

PROF. 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?

PROF. 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.

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

PROF. 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.

PROF. 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?

PROF. 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.

PROF. 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?

PROF. 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 \--

PROF. 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.

PROF. 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?

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

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

PROF. 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?

PROF. 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.

PROF. GEORGE: This is really my question.

PROF. 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.

PROF. 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.

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

PROF. GEORGE: No guarantee. I understand that.

PROF. BLACKBURN: Right.

PROF. 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?

PROF. 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.

PROF. GEORGE: I want to say \-- go ahead that\'s fine. Go ahead,
Michael.

PROF. SANDEL: Going back to the moral status \--

PROF. 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?

PROF. 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?

PROF. 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]{.underline}
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]{.underline}
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.

DR. GOMEZ-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?

DR. GOMEZ-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?

DR. GOMEZ-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?

PROF. 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.

PROF. 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.

PROF. 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.

PROF. 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.)

PROF. GEORGE: Can I just cite an article I\'ve written?

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.)