UNITED STATES OF AMERICA

THE PRESIDENT\'S COUNCIL ON BIOETHICS

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FIFTH MEETING

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TUESDAY,

JULY 11, 2002

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The Council met in 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

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.

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, Chairman Kass 3

Session 1: Human Cloning (Final): Council\'s 4

Report to the President

Personal Comments by Council Members 26

Press Availability 47

Session 2: Regulation 4: Patentability of 58

Human Organisms 3

Session 3: Stem Cells 4: NIH Funding of 98

Stem Cell Research (Implementation)

Dr. Wendy Baldwin, Office of Extramural

Research, National Institutes of Health

Session 4: Enhancement 2: Potential for 147

Genetic Enhancements in Sports

Dr. Ted Friedmann, University of

California-San Diego, and Chairman,

Recombinant DNA Advisory Committee

Adjournment

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

(9:05 a.m.)

CHAIRMAN KASS: Could we get started?

Welcome to this, the fifth meeting of the President\'s Council on
Bioethics, actually the fifth meeting in a grueling six months, and I
want to welcome council members back after a short hiatus. And we\'re
very grateful to you for being here.

This is a regular meeting, and we have a full agenda after this session,
including return to the discussion of the patenting of human organisms.

This afternoon we will have a report from Dr. Wendy Baldwin from the NIH
on the implementation of President Bush\'s stem cell policy of last
year.

At the end of the day, the last session, we have Dr. Ted Friedmann, who
will be discussing with us the possibilities for genetic enhancement of
athletic performance.

And then tomorrow morning we will return to what we call in-house search
for a richer bioethics and pursue with the question of the relation
between human identity and the body, using a wonderful short story by
Richard Selzer called \"Whither Thou Goest.\"

And we will finish with a discussion of our future plans and have time
for our usual public comment.

The first session this morning is devoted to the release of our report
to the President, \"Human Cloning and Human Dignity: an Ethical
Inquiry.\" Here is the text, and I hope all of you have them at your
place.

This is a pre-publication copy, not the final copy, made available for
the first time officially today. No copies were distributed in advance.
They are available at least until the supply is exhausted on the table
outside, and after the supply is exhausted for anybody who is
interested, there will be extra copies of an executive summary.

The text of the report will be available if the promises are kept on
line in HTNL form by 10:00 a.m. this morning. The Web site is
www.bioethics.gov.

I want to begin by expressing my personal thanks to the members of the
Council for your superb efforts at meetings, between meetings, and in
your comments, your critical suggestions to the multiple drafts made by
the staff.

You were selected not to be some rubber stamp body, but to be the
heterogeneous and thoughtful and articulate group that you are. Our
opinions in this room have been keenly held and in sharp disagreement,
but they have been well articulated, and this is perfectly appropriate
because the issues are vexing; the passions are high; and it is very,
very hard to think one\'s way through this.

Nevertheless, it seems to me that we have done exceptionally well in
proceeding in the spirit of goodwill and collegiality and with respect,
even some appreciation for the viewpoints which are not our own. And I
thank you very, very much for proceeding in that spirit.

I also want to express my deep gratitude to Dean Clancy and wonderful
Council staff for your monumental efforts under very trying
circumstances to produce this document.

We\'ve had three weeks since the last meeting, and this document is some
145 pages, plus personal statements, plus bibliography, plus glossary.
And the staff is to be commended for just heroic work.

The procedure this morning is as follows. I will make an opening
presentation of the report. Then there will be time for brief comments,
ladies and gentlemen, up to two minutes from those members of the
Council who have notified the Chair in advance that they wish to speak.
And then we will take some questions from the media.

There is a microphone there, and if you will step forward when the time
comes.

I\'d like to begin by putting the report of the Council in its context,
and to begin by reminding everyone of the mission of this Council
according to the Executive Order that was used to create us. This is in
the preface.

\"The Council\'s purpose is to advise the President on bioethical issues
related to advances in biomedical science and technology, and in
connection with its advisory role, the mission of the Council includes
the following functions: to undertake fundamental inquiry into the human
and moral significance of developments in biomedical and behavioral
science and technology; to explore specific ethical and policy questions
related to these developments; to provide a forum for a national
discussion of bioethical issues; to facilitate a greater understanding
of bioethical issues; and to explore possibilities for useful
international collaboration on bioethical issues.\"

This is, to begin with, an ethics council, and our first questions will
not be simply will it work, is it safe, and how much does it cost. But
is it good, right, just, noble, wise, and prudent?

And first, even before getting to that question, the first task is: what
does all of this mean? The first assignment is to explore the human and
moral significance of these developments, and that is the spirit in
which we have been proceeding.

Second, why the subject of human cloning? Why was this our first
project?

First, because there have been steps moving fairly rapidly beginning
with mammalian cloning over the last five years, and there was the
announcement last fall of perhaps the first successful attempt at the
cloning of human embryo, and there are reports that some fertility
specialists are, even as we speak \-- unsubstantiated reports, that
there are efforts undertaken to produce a cloned child.

This has been the subject of intense public debate, and it is a debate
which has been complicated because of the discovery of human embryonic
stem cells which hold enormous promise for regenerative medicine, and
therefore, the question of the promise of cloned stem cells emerges as
an issue in this discussion.

This was not a topic of the discussion when the National Bioethics
Advisory Commission had to take up this report, this topic five years
ago.

Nevertheless, it seems to me the reason that we have taken this up is
because the power to clone human beings is not really just a new tool
for overcoming infertility, nor is it just an adjunct to the treatment
of disease, but it seems to involve a crossing of the line between
sexual and asexual reproduction. It might possibly represent an early
step toward the genetic control of the next generation.

And lots of people sense that in this issue are things even beyond the
importance of cloning itself, that this might be something as a first
instance of something quite momentous.

The group process, I will just sort of make it clear how we have
proceeded. We have met now \-- this is the fifth meeting in which we
will have met to discuss human cloning. We have had 12 90-minute
conversations on this subject.

We\'ve heard presentations on the recent cloning report of the National
Academy of Sciences; presentations on stem cells, embryonic and adult.
We\'ve had a presentation on the ethics of embryo research and on the
international systems of regulation of embryo research and assisted
reproductive technologies.

We\'ve had a great deal of public comment, both oral and written, and we
have done a fair amount of reading and discussing amongst ourselves.

I want to say before turning to highlights of the report proper, say
something about some of the principles that have guided us.

First of all, we didn\'t begin simply with the technique and its impact,
but chose in all cases, wherever we went in this report, to discuss
things on the plane of the human goods that these technologies could
either serve or threaten.

In the first case, the importance of human procreation, individuality,
questions of the relation amongst the generations, the importance of
human healing and the adjunct, the great importance of its allied
biomedical science and technology.

And finally, the treasured, but delicate relation between science and
society, which offers science the freedom to progress to serve
humankind, but also always within the moral limits and social norms of
the community.

Second, we have not striven here for consensus. It will be reported that
this council failed to reach consensus. That would be a deep
misunderstanding. There was no desire to produce consensus here in the
first place.

There was from the beginning the recognition that these are hard
questions, that there were competing views. We wanted them forcefully
presented, and just as President Bush did when he tried to reach his
decision on embryonic stem cell research, when he consulted as widely as
possible and heard from as many different viewpoints as he could, we
have decided and we were charged in a way from the very beginning not to
be guided by an overriding concern to reach consensus, but to develop
these positions in as strong a way as possible so that the President and
everyone else would understand what would be gained and what would be
lost in choosing A rather than B or B rather than A.

Finally, I want to say something about the relation between the inquiry
and its conclusion. Today\'s news will be entirely about the result.
I\'ve learned since coming to Washington that the thing that people care
about is the bottom line and are you for it or against it.

We\'ve come to a bottom line, but I don\'t regard the bottom line as the
most impressive thing about our achievement. I think that the more
lasting value, I hope, will be in the arguments, the reflections, the
reasoning of this report.

The issues are going to be with us long after whatever decision is made
on the current topic, and it is my sincere hope that what we\'ve done
here could be of some help to people who follow in thinking about these
questions.

I now want to hit just some of the high points of the report. I won\'t
read the executive summary except in a few paragraph where I think I
can\'t improve upon what the staff has done there.

But first of all, in the first chapter, which I think is somewhat
distinctive of what we have done, we have placed, as I already said, the
subject in the larger human context, the context of human procreation,
like entity individuality and the like, in the context of the moral
meaning of health and the value of biomedical research, in the context
of the tacit moral contract between science and society, and lurking
behind this, the context of the nature and worth of human life in all
its stages.

This is what we lead with in the opening chapter, and it sets the stage.

There\'s a chapter on the history which touches only very lightly on
what has transpired from the time when cloning was science fiction until
the time when it is fact at least in mammals and perhaps, perhaps, in
humans to come.

Third, a chapter on terminology, and here I think we have something of
considerable importance to contribute. Our first effort, and a difficult
effort it was, was to clarify the confusing terminology that confounds
the public discussion beginning with the term of human cloning itself.

And for people who are interested in the results, what you need to know
is the terms that we are adopting here will be cloning to produce
children, cloning for biomedical research, and we regard the immediate
product of somatic cell nuclear transfer for whatever use as the cloned
human embryo.

Whatever the purpose for which cloning is undertaken, the act that
produces the genetic replica is the first step, the creation of an
embryonic clone. Accordingly, we mean by human cloning the production of
cloned human embryos, the earliest stages of developing human life, with
the intention of either transferring them to a woman\'s uterus to
initiate a pregnancy or taking them apart in order to procure embryonic
stem cells.

The first use of cloning has come to be known as reproductive cloning or
just cloning. The second has come to be called therapeutic cloning,
research cloning or nuclear transfer or stem cell research.

The Council has chosen for reasons articulated in the analysis in
Chapter 3 to call them instead cloning to produce children and cloning
for biomedical research. We think these terms accurately describe the
two activities involved and allow us then to debate the moral arguments
without euphemistic distortion.

Whether we favor or oppose cloning to produce children, whether we favor
of oppose cloning for biomedical research, we must acknowledge that both
uses of cloning begin with the same act, the production of cloned human
embryos.

Next, in the fourth chapter, which I will not review, is scientific
background which touches quite a number of things that are relevant at
least in the continuing consideration of our report. We have drawn very
heavily on the marvelous report of the National Academy of Sciences on
the scientific and medical aspects of human reproductive cloning, and
that report was a great blessing to our efforts.

Next, to now turn to the ethical discussions, the rest of these remarks
will be about the ethical discussions, and then finally the policy
recommendations.

In Chapter 5 we deal with the ethics of cloning for biomedical research.
We do consider the case for cloning. Excuse me. Sorry. I misspoke.

The ethics of cloning to produce children, and we do consider the case
in favor of cloning to produce children from the treatment of
infertility to the replication of a loved one or even of individuals
deemed to be superior. But we are not persuaded by this argument.

And we make a case against human cloning that builds on, that goes
beyond the case that has been made by our predecessors. We concur that
cloning is unethical at this time because it is unsafe both to the
prospective children to be, as well as to the participating women who
are either egg donors or carriers.

But we try to extend the discussion of the safety question into an
abiding moral concern grounded in our duty not wilfully to put at grave
risk the children to be who would be the products of this activity, and
we raise serious questions as to whether the safety concerns are merely
temporary or whether they might be enduring and even permanent.

Second, we go beyond the discussion of safety to undertake the broader
ethical critique that was recommended both by the National Bioethics
Advisory Committee report and by the National Academy of Sciences, and
there by means of a primary discussion of the nature of procreation, we
mount a larger critique of human cloning, raising questions about issues
of identity and individuality, concerns about steps leading toward
manufacture, questions of the possibility of an opening here to eugenics
in this primary and initial decision that would involve the genetic
modification, the genetic preselection of the genotype of the next
generation, questions of troubled family relations, and also certain
concerns about the effect on society that has become a cloning society
even if it is practiced only on a small scale.

All members of the Council find all of these reasons equally persuasive,
but we\'ve put them before everyone for their serious consideration. The
conclusion in that section is not only is human cloning unsafe, but it
is also morally unacceptable, and it should not be attempted. There the
Council is unanimous.

Coming to the difficult topic, much more difficult topic, on the ethics
of cloning for biomedical research treated in Chapter 6 of the report,
here I would like to read a paragraph from the executive summary on page
18.

\"The ethical assessment of cloning for biomedical research is far more
vexing. On the one hand, such research could lead to important knowledge
about human embryological development and gene action, both normal and
abnormal, ultimately resulting in treatments and cures for many
illnesses and disabilities.

\"On the other hand, the research is controversial because it involves
the delivered production, use, and ultimate destruction of cloned human
embryos, and because the cloned embryos produces for research are no
different than those that could be used in attempts to produce cloned
children.

\"The difficulty is compounded by what are for now unanswerable
questions as to whether the research will, in fact, yield the benefits
hoped for and whether other promising and morally nonproblematic
approaches might yield comparable benefits. We simply do not know.\"

The Council, reflecting the differences of opinion in American society,
is deeply divided regarding the ethics of research involving cloned
embryos, but \-- and this point I want to stress \-- we all agree that
the parties to this debate have concerns vital to defend, vital not only
to themselves, but vital to us all.

No human being and no society can afford to be callous to the needs of
suffering humanity or cavalier about the treatment of nascent human life
or indifferent to the social effects of adopting one course of action
rather than another.

What we\'ve done in Chapter 6, and this is an experiment, we have put
together in one document not a search for consensus, but in fact, two or
two and a half briefs made in the first person plural by proponents and
opponents of cloning for biomedical research.

Both sides have been asked to consider what is owed to the embryo. Both
sides have been asked to consider what is owed to those who suffer. Both
sides have been asked to consider what is owed to the entire society.

And the conclusion, I think, just to simply state the conclusion and
allow me to read the rest, the moral case for cloning for biomedical
research is powerfully stated. It rests on our obligation to try to
relieve human suffering, an obligation that falls most powerfully on
medical practitioners and biomedical researchers.

We, speaking for that group, who support cloning for biomedical
research, all agree that it may offer uniquely useful ways of
investigating and possibly treating many chronic debilitating diseases
and disabilities, providing aid and relief to millions.

We also believe \-- I\'m now speaking from the mouth of the proponents
\-- we also believe that the moral objections to this research, though
genuine, are outweighed by the great good that may come from it.

At this point there was a division in that group. Some see much greater
moral concern in the risks of going too far and other moral hazards and
would argue that this research needs to be extremely carefully
regulated.

A small number of Council members do not believe that the very, very
early embryo has that kind of moral standing, would favor this research
with enthusiasm, but both of those groups are absolutely in agreement on
the importance of the research and give it their ethical approval.

The second group presenting the moral case against cloning for
biomedical research acknowledges the possibility, though still
speculative at the moment, that medical benefits might come from this
particular avenue of experimentation, but we, now speaking for that
group, believe it is morally wrong to exploit and destroy developing
human life even for good reasons, and that it is unwise to open the door
to many undesirable consequences that are likely to result from this
research.

This group finds it disquieting, even somewhat ignoble to treat what
are, in fact, seeds of the next generation as near raw material for
satisfying the needs of our own, and they make various kinds of moral
arguments which I will not here research.

In short, what we\'ve tried to do in that chapter is not reach a
conclusion, but to present full throated defenses of the two sides, each
side also having to address the other side.

Perhaps one word with respect to the second position, which acknowledges
that they must pay heed to the voices of the suffering and will accept
the burden of perhaps saying no to things that might be beneficial to
claims that they want to leave to our children, a world in which
suffering can be more effectively relieved, but also a world in which
one wants morally to live.

Next, in Chapter 7 we discuss the various public policy options. Mindful
of the importance of scientific freedom and the need for moral
boundaries and mindful of the way in which human cloning in other
countries has not been dealt with in isolation, as we have largely done
it here, but in the context of embryo research, reproductive
technologies, and genetics, and we outline and discuss the strengths and
weaknesses of seven different policy options from no legislation and
self-regulation to a permanent ban on everything.

In the final chapter, the Council, having thought about those seven
options, coalesced around two recommendations, which we put forth as
alternative recommendations flowing from this Council, and these are as
follows.

The majority recommendation \-- this is in the executive summary on page
21 if you are following \-- ten members of the Council recommend a ban
on cloning to produce children, combined with a four-year moratorium on
cloning for biomedical research.

We also call for a federal review of current and projected practices of
human embryo research, pre-implantation genetic diagnosis, genetic
modification of human embryos and gametes and related matters, with a
view to recommending and shaping ethically sound policies for the entire
field.

And there follow then, and the hour is late, a whole series of arguments
in defense of this proposal, the most important of which is the claim
that there is a need for ongoing public moral debate before one decides
to cross this grave moral threshold, which the proponents of this view
believe either should not be crossed or should not be crossed as yet
without further deliberation.

And some members supporting this position support the moratorium because
they would like this temporary ban to provide the incentive to develop
schemes of regulation that, should the ban be lifted, might allow this
research to go forward, and they also want cloning to be considered \--
all of us want cloning to be considered \-- in the larger context.

I should say that the Chair belongs to that party.

The other recommendation supported by seven members of the Council and
on page 23 recommend a ban on cloning to produce children, but \-- sorry
\-- and recommend with regulation the use of permission to use \-- this
looks like there\'s a typo here.

They recommend that there be a ban on cloning to produce children, but
support, approve now the use of cloned embryos for biomedical research,
but with regulation.

And here the argument is clear, again, that the permitting cloning for
biomedical research now, while governing through a prudent and sensible
regulatory scheme, is held by this group to be the most appropriate way
to allow the important research to proceed, while insuring that the
abuses are prevented.

This group does worry about some of the dangerous consequences, but
believes that a system of careful, strict federal regulation could
prevent those untoward effects, and they want to lend their support to
allow this research to go forward at the present time.

That is the main body of the report. There is a bibliography, and in
keeping with the spirit of our enterprise and in order to contribute to
further public discussion and to continue to allow individual members
here to speak in their own voice, you will find at the back of the
report an appendix of personal statements in which individual members
who have chosen to do so have added their own statements, and we commend
them for your attention.

There should be two supplements. There was error in the version of Dr.
Foster\'s statement that was included in the book and Dr. Rowley\'s
statement is available as an insert. I hope it\'s in the volumes that
you picked up. If not, it\'s available in the back.

Finally, let me just say since the newspapers are already speaking about
what the legislative implications are here, and let me say that I would
say that as I understand what it is that is being recommended by the two
sides, the view of the majority is that there should be no legal human
cloning of any sort at this time, and that pending the necessary debate
and review both of cloning and of the whole area, that only a moratorium
could make possible that no law should now be enacted that would
authorize or approve human cloning, that would give the green light to
it.

The other position, the minority position, argues that cloning for
biomedical research should now be approved legislatively in principle,
but it should not proceed in the absence of an enforceable system of
federal regulation. That I take to be the gist of what this means for
people who want to know what does this matter to the debate that goes
elsewhere.

That is it. I\'m sorry to have been a little long winded, but I\'d
rather err on the side of thoroughness.

I have six people who have asked to make short personal comments
beginning with Rebecca Dresser.

DRESSER: Thank you for this opportunity.

Settling on our final recommendations was difficult for me and for
others on this Council, but as a teacher and student of bioethics, I\'m
proud to have played a role in shaping this report.

The report, of course, is not perfect, but I think it is a full and fair
examination of the issues, and I believe that it will advance the public
and policy examination of human cloning.

As a member of this Council, I believe I have a responsibility to
consider not just my own views, but also those of others with interests
in our national policies addressing research using human embryos. I do
not think we have sufficient agreement in this country about the
morality of producing embryos for research to adopt the regulation
approach that Proposal 2 endorses.

Going forward at this point could be divisive and could reduce the
chance for developing an oversight approach that would be acceptable to
a majority of citizens.

Proposal 2 could actually be criticized for going too far in labeling
cloning for research permissible, but it could also be criticized for
not going far enough in that it really doesn\'t address the federal
funding question.

Without federal funding, little of the basic research that scientists
want to do is likely to go forward. For many years Congress has
prohibited federal funding of any research that destroys human embryos.
With time for further deliberation and further scientific work to
indicate whether it is necessary to create embryos to develop stem cell
and other therapies, it is possible, I think, a consensus will emerge on
the appropriate national policy to govern this very contentious issue.

Now, that consensus might be to go forward and to provide federal
funding for the work, or it might be to refrain from permitting
production of research embryos because of the moral objections and
because there are alternative research approaches to developing
therapies.

The issue of whether to approve cloning for research is not ripe for
policy resolution. It\'s not ethically ripe, and it\'s not
scientifically ripe. It\'s too early to know whether or not people in
this country believe that possible gains to patients justify the risks
and losses that could come from creating embryos for research, and it\'s
too early to know what we would be giving up if we refrained from taking
this step.

Possible benefits to patients are not the only ethical consideration
bearing on research policy, and studying stem cells from cloned embryos
is not the sole avenue to delivering benefits to patients.

In the next four years, there will be many other research opportunities
to investigate the potential benefits that stem cell studies could
produce and many other opportunities to benefit patients through better
delivery of existing health care services.

These alternatives will, I hope, be pursued during four years of
continued deliberation over the creation of embryos for research
purposes.

Thank you.

CHAIRMAN KASS: Thank you.

Paul McHugh.

DR. McHUGH: Thank you very much, Leon.

I wanted to comment on this report and my position on it in relationship
to my views of SCNT, or somatic cell nuclear transplant, that I have
articulated at this table and have put at the end of the report.

As you know, I believe that SCNT is an issue of wonderful new discovery
in cellular biology and it represents a form of biological engineering
that, at least at its onset, produces cells and not human beings, and
that those cells, therefore, are licit to be used in various ways.

I don\'t want to further that discussion right at the moment, but I do
want to draw from that why I then choose to speak about a moratorium
here, as our country thinks further about the implications of the use of
this form of biological engineering and study.

I believe that there are three problematic aspects that still remain
unresolved even if you accepted my position of SCNT, and these problems
need to be worked out and thoroughly discussed as to their implications
for the future by the American people, and I believe only a moratorium
that calls attention to these three problems \-- by the way, there are
many other problems, but these three problems, one an immediate problem,
one an imminent problem, and one an ultimate problem.

Two of them have been discussed before in this Council. An immediate
problem is that the requirement for SCNT, human SCNT, is to find human
oocytes. If this research is to go forward, there are going to have to
be hundreds, maybe thousands of human oocytes, quote, harvested from
women.

I fear and see the turning of some women into egg factories, and no man
or woman can look at that with ease and comfort.

We should be talking about what that means both practically and morally.

The second, less immediate, but an imminent problem comes out of my
opinion that SCNT at first produces cells, and that those cells are
suitably used. My colleagues and others have pointed out to me that this
phase is just one phase in the potential of these cells, and that these
cells could be put into some artificial or real uterus and developed
further for the production of organs; that if the cells of the SCNT
could be harvested, why couldn\'t the organs be harvested?

And I believe that we should be talking about what that would imply,
using a fetus for the production of organs, and again, I think a
moratorium would help to see that.

But then there\'s an ultimate problem, and it\'s a problem that relates
to the existence of this technology and the potential ultimately of
producing a child. And this, of course, is the issue that we want to
address by banning human reproductive cloning.

Now, I don\'t feel that anything that has been said in here or in the
National Academy of Sciences has really come to some of the ultimate
issues that relate to human cloning for reproduction that our beginnings
could permit.

Let me remind you that Charles Krauthammer\'s favorite animal is Dolly,
and I\'ve been looking at it since he\'s called that to my attention,
and a recent ad has shown Dolly with her lamb, and that really drove
home something to me and, I think, anyone who looks at this picture and
imagines it in human terms.

That is, that a human cloned would then be able to reproduce, and the
reproduction would go through and produce a lineage of genes from that
cloned product.

Now, I do not know that anybody can assure me that the process of
scrubbing the genome that is represented by SCNT will not in some way
produce delicate but important changes in the genomic structure that
would then pass into a lineage forever.

I work with Huntington\'s disease patients. Huntington\'s disease is an
extremely interesting disorder at one level in that it represents the
expansion of a trinucleotide repeat in the genome of a human being.

We have many trinucleotide repeats in our genome, but very few of them
\-- fortunately, none of them tend to go critical and expand and, thus,
produce a condition like Huntington\'s disease, which passes on
generation after generation.

Diseases like Huntington\'s disease, fragile X syndrome, some forms of
muscular dystrophy, and others represent lineages from trinucleotide
repeats that went critically in some family.

I think it\'s an ultimate and perhaps enduring question as to whether
the manipulations of this human genome may not in some way produce a
lineage of disorder. Some of them that we know of, like Huntington\'s
disease, are some of them that might be new pathologies that would then
go generation after generation produced by the science of today.

And I\'m concerned about that to the point where I think that we should
be discussing it as also a third issue in a moratorium and heading
towards regulation.

In fact, when I think about it, I\'m sorry. I depend in my clinical
work, of course, on very much basic science, and am very sorry to speak
for anything that hinders and slows science. But I do think that this is
a situation that calls for that in these three ways.

And I\'m disappointed, in fact, that the scientific community hasn\'t
come forward to say that there would be a voluntary moratorium while
they considered these matters and discussed them thoroughly as to their
implications for the future.

Thank you.

CHAIRMAN KASS: Thank you.

Michael Sandel.

PROF. SANDEL: Thank you, Mr. Chairman.

Some may be surprised that this Council is not recommending a ban on
cloning for biomedical research. Neither of the policy recommendations
this Council has put forward endorses the ban on research cloning passed
by the House of Representatives last year.

Some members of this Council, a sizable minority, have argued powerfully
for such a ban. Although they did not persuade a majority to accept
their view, their position is worthy of the utmost respect.

Among those of us who hare rejected an outright ban, most would permit
the research to go forward subject to regulation, whereas some favor a
moratorium.

These positions are laid out clearly and candidly in the report in the
table on page 129. Seven members favor a ban, seven favor permitting the
research subject to regulation, and three favor a moratorium.

When the membership of this Council was first announced, some critics
complained that President Bush had stacked the Council to insure a
particular outcome. I believe that this report, if carefully read, will
put that charge to rest.

The President could easily have stacked this Council to guarantee
support for a ban on cloning for biomedical research, but he didn\'t do
that. He wanted a group of independent minded people who would wrestle
honestly with hard ethical questions so that the best arguments on all
sides could be placed before him and before the American people.

The President deserves enormous credit for that choice, which I believe
will serve him and the country well in the long run.

And our Chairman, Leon Kass, deserves great credit and appreciation for
leading these discussions with integrity and fairness.

CHAIRMAN KASS: Thank you.

Alfonso Gomez-Lobo.

PROF. GOMEZ-LOBO: It has been a great honor and a deeply felt
responsibility for me to contribute to the deliberations on human
cloning of the Presidents\' Council on Bioethics.

After much thought, much difficult thought, it seems to me that human
cloning, if carrier out, will represent a major step towards a radical
instrumentalization of human life. It would be the ultimate
transformation of a growing and developing human being into mere
research for experimentation.

That a human life begins shortly after fertilization or of somatic
nuclear transfer is neither a matter of subjective opinion nor of
religious belief. And I want to insist on this point.

By itself, that is, without the contribution of science, none of our
major religious traditions is equipped to decide the issue. When our
life begins is a matter to be decided not by faith, but rather by reason
in light of contemporary embryology.

As a recent article in the journal [Nature]{.underline}, July 1st, the
journal [Nature]{.underline} shows, the mammalian body plan with its
diverse functions starts being laid down \-- and I literally quote from
the [Nature]{.underline} article, from the moment of conception,
unquote.

To claim that a human embryo cloned or naturally conceived is a clump of
cells is like describing a car as a bunch of wheels. This expression
totally misrepresents the structure and nature of an automobile.

Likewise, an embryo is much more than a heap of cells. It is a unified
organism, a self-moving whole programmed from the start to go through
its natural stages until she becomes, if given the appropriate
conditions, an adult like us.

An embryo does not yet have a functioning nervous system or a brain, but
if nurtured properly and not wilfully deprived of her natural
surroundings, will have them within a short time. Sentience and thought
are natural outcomes of the earlier stages.

The very idea of cloning for biomedical research rests on the assumption
that the internal genetic program of the embryo is at work and will lead
to the blastocyst stage, and at this point stem cells will be extracted.

It would be a euphemism to say that the embryo is then lost. It is, of
course, intentionally dismantled.

The recent advance for research cloning, of course, is the promise of
cure for numerous illnesses. My family and I, I must confess, are among
those who would benefit tremendously from those cures.

But \-- and I pose the question to myself ‑- does this admirable and
desired end justify the questionable means? And after much thought, I
have to answer no.

As a result of all that I have learned from my colleagues and from the
material provided by the excellent staff of the Council, I would like to
make two exhortations.

One is an exhortation to all Americans to familiarize themselves with
embryology and the real nature of research cloning. It is not simply a
procedure directly to produce stem cells. It is a procedure that entails
producing human organisms, letting them grow according to their own
devices, and then destroying them.

Any suggestion that this can be done in a morally permissible way before
14 days is, in my opinion an illusion. There is no bright or dim light
at that point. We were already before 14 days the human beings we are
now, and this, above all, should be a deep concern to our legislators.

My second exhortation is to those members of the community who have
devoted their lives to science and medicine. We admire you; we support
you; and we depend on you for our own well-being and that of our
children and grandchildren.

But we urge you to be mindful of the ethical implications of dealing
with human subjects who cannot give consent and are going to be treated
as mere instruments for the benefit of the rest of us.

We urge you vigorously to pursue truth and healing, but in strict
observation of the principle that commands us never to treat a fellow
human being, no matter how young, merely as a means towards our ends.

Thank you.

CHAIRMAN KASS: Thank you.

Let me see. Janet Rowley. Mike, do you want to go first?

I want to alternate. We have two new additions, and I\'d like to bring
you in. Mike, would you like to go?

DR. GAZZANIGA: Sure.

CHAIRMAN KASS: Mike Gazzaniga.

DR. GAZZANIGA: I think Mike Sandel stole my notes. I echo completely his
sentiments and his statement that this committee has worked fairly and
in the open, and every time one would call with a suggestion, the answer
always was, \"We\'ll put it in there.\"

There never was any sense of override. There never was any blocking of
any point of view. And for those of you who actually read the report,
every viewpoint that the individuals of this committee have is
represented in the report.

I do want to remind that this is a committee not of scientists, but of
professionals looking at ethical questions, and echoing Mike Sandel\'s
point, on page 129 the majority of the committee actually has no problem
with the bioethics of biomedical cloning, but we vary in the extent and
speed with which we want to go forward.

I would just conclude with the thought that it is our great intellect
that finds many of us at this table still alive from prior biomedical
advances, and I think the objective of biomedical cloning is have us
alive and healthy during these aging years. So I hope the process will
go forward.

Thank you.

CHAIRMAN KASS: Thank you, and a long life to you, Mike.

Let\'s see. Gil Meilaender.

PROF. MEILAENDER: I wanted to say just a few words about the policy a
majority of our Council has recommended with respect to cloning for
biomedical research, a policy that I support.

That recommendation, a four-year moratorium, is in some ways not the
very best policy that I can imagine. The best would be simply to try to
say a lasting no to all human cloning for reasons one can find set out
in detail in parts of Chapters 5 and 6 of our report.

Not all Council members agree, but some of those who do not yet agree
\-- note the hopeful tone there \-- some of those who do not yet agree
share many more reservations about proceeding with research cloning now.
Our partial agreement is, I think, a considerable achievement, given the
circumstances under which we\'ve forged it in a rather short time.

Were it enacted into law, it would prohibit all human cloning whether
publicly or privately funded for four years. That is to say for that
period of time, we would have the best policy in place, and our deeply
divided society would have continued opportunity to think, to talk, and
even to argue about the morality of human cloning, opportunity to take
seriously the limits on our own wisdom and goodness, opportunity to
question even our most praiseworthy motives.

Beyond that, I make three observations, each very brief, about the worth
of a moratorium.

First, some might describe our four previous meetings of a day and a
half each over a half year as six months of searching ethical and
scientific inquiry. I think that sets the bar too low, lower than I\'d
want to set it anyway.

I think, on the contrary, that neither this Council nor our society has
really yet fully plumbed the depths of the moral issues in human cloning
and embryo research. There\'s much more to be done, some that we
haven\'t done, some that we\'ve hardly been willing to do, and we can
use a moratorium to think more deeply and fully.

Second, I used to think that I could never care about any child the way
I did my own children. then I spent a decade as a foster parent, and I
learned I was wrong. My feelings and my moral sensibilities had not been
a very sound moral guide. They needed to be reshaped and redirected, and
that really took years.

Perhaps the feeling of those like myself who see an industry of research
cloning as abhorrent are wrong. Perhaps, on the other hand, the feelings
of those who see relatively little moral problem with cloning for
biomedical research are an unsound moral guide.

It will be good for our moral health to take more time to think this
through.

Third, Oscar Wilde is famous for having described the cynic as the man
who knows the price of everything and the value of nothing. We\'re
engaged; we have been engaged in an attempt to think through some very
important questions about the value of things, questions that cannot be
reduced simply to costs and benefits.

I believe it will serve the moral health of our society to take
additional time to do so.

Thank you.

CHAIRMAN KASS: Thank you.

Now Janet Rowley, please.

DR. ROWLEY: I, too, want to echo the compliments of my colleagues around
the table both for Leon specifically as well as for the staff for the
openness of the discussion that we have had in these last months, and
many of you in the audience have been here and sat through a day and a
half of discussions, and I salute those of you who were in attendance
because I think it was a surprise to me to see that all of our
deliberations would be conducted in this kind of goldfish bowl, but I
think it\'s a very strong and important statement for the country to see
the discussions and the meeting of intellects, if not the coming to
agreement of individuals trying to deal with very, very serious issues.

And I think that it is important to emphasize that those of us in the
scientific community who would espouse more progress certainly recognize
the very sensitive issues that we are dealing with at this particular
time. It\'s been raised both in the report by Dr. Kass and by others
that we have asked many questions during this time, and we\'ve found
answers.

I want to focus on why we have so few answers to the questions, the
critical questions, that we have asked. And for me the answer is
shockingly clear. Most American scientists have been prevented from
working on these very critical problems because of a ban on any
federally funded research using cells from human embryos, and this ban
has been in existence since 1994.

We\'re not proposing that we stop active research now. We\'re saying
that we should continue this prohibition on research by federally funded
scientists, which really has been the engine of all biomedical progress
in the past.

And I have to say why continued ignorance is a wise public policy
escapes me.

It is clear that in addition to wanting to move ahead with funding
research, that as I\'ve already said research using these cells requires
great sensitivity and careful thought.

And as a matter of fact, all academic institutions have an institutional
research board in place where the research that is proposed,
particularly that involving human subjects, is very carefully reviewed
by the institution before grants can be submitted to any agency.

In fact, in 1998, NIH had a working group developed that proposed
guidelines for pluripotent stem cell research, and this was approved
after extensive public comment. More than 50,000 comments were received
in response to the announcement, firstly in the [Federal
Register]{.underline}, in the final report, and guidelines were
published in the [Federal Register]{.underline} in August of 2000.

And at that time, there was a proposal for the establishment of the
human pluripotent stem cell review group. In fact, this group was
constituted, but because of the election never met.

The group consisted of \-- broadly represented the American public with
consumers, ethicists, lawyers, as well as scientists.

And so despite the claims in part of our report, there is no evidence
that I\'m aware of that scientists oppose the formation of such a
research board. In fact, as I\'ve already said, members of such a board
were already selected.

The proposal, again, in our part of our report, to exclude knowledgeable
scientists from the review panel will, I think, perpetuate the serious
handicap under which our own Council has labored in not having experts
as members of the Council who are constantly available to inform us in
our discussions.

We are dealing, as we\'ve all discussed with competing moral goods, and
we spend a great deal of time, of paper, many pages discussing the moral
rights of a single cell.

There\'s very little discussion of the moral rights of patients and the
potential benefits to humanity of this research. Again, part of this is
because of our ignorance, and our ignorance is due to the fact that we
cannot do the science that\'s required to answer these questions and to
spend four more years in ignorance, I think, is extraordinarily
distressing at least to me.

So I think that Congress should lift the ban on human embryonic research
and should establish a broadly constituted regulatory board now.

CHAIRMAN KASS: Thank you very much.

The last comment is from Charles Krauthammer.

DR. KRAUTHAMMER: Like Professor Meilaender, although for possibly
different sets of moral reasons, I oppose all cloning, reproductive and
research. I would like to see them banned.

but I live in the real world, and in the real world there is no
consensus either in American society or on this Council for such a
permanent ban right now.

And I might say in echoing the remarks of Professor Sandel that the fact
that the pluralism on this issue in the country is reflected by the
pluralism on this issue in the Council gives lie to the impression
widely disseminated that this Council was stacked to produce an
ideological result.

The fact that we have produced this variety of opinions and this kind of
division, I think, gives light to that. Not only have the members of the
Council with differing opinions shown respect for each other\'s
positions, but they have both in our discussions and in the report
recognized the valuable goods represented by the other side, and that
one necessarily forfeits in proposing ones own position.

Given this pluralism, I think that recommending a moratorium as the
majority of this Commission has now done is more than a compromise.
It\'s an achievement.

And the reason it is an achievement is because the creation of human
embryos solely for the purpose of experimentation is a significant moral
barrier, and by proposing a moratorium, we recognize the significance of
the barrier and the importance of it not being crossed.

Creating embryos solely for their exploitation and research and therapy
is new. It\'s dangerous, and I believe that we will live to regret it
were we to allow it to go ahead.

The reason the moratorium is so critical is because without any such
action today it will go ahead. We already know that the Jones Institute
has created human embryos using sperm and eggs for experimentation. We
know that Advanced Cell Technology has attempted to create human embryos
solely for experimentation using cloning techniques.

In the absence of any action here, in the absence of any action by the
Congress, this barrier will be breached.

I think the importance of what we have done is that a Council of people
drawn, as Michael Sandel pointed out, from the different perspectives,
reflecting different points of view, that such a Council has come
together and recommended in the majority that this barrier not be
breached is extremely important. It represents a recognition that the
country needs, and I think it is a significant contribution to the
debate and to the moral health of the country.

Thank you very much.

CHAIRMAN KASS: Thank you very much.

As a matter of personal privilege let me say that I am just thrilled
with the comments that have just been made around the table and not
simply for their kind words for the Chair. People who are with us for
the first time have just gotten a taste of the kind of discourse that
we\'ve been having here.

I can\'t say I\'m sorry we\'re finished with human cloning, but this was
a very nice way for the Council to finish its discussion, and I thank
you all for the thoughtfulness and high moral principle behind all of
the statements, and I\'m very grateful.

We now invite people from the press to come to the microphone and ask
questions. We have another session beginning at 10:45. So this will be
brief. We\'ll take a break, and then people can speak in the interim.

But please step forward to the mic and identify yourself and ask
whatever questions you might have.

There will be a session tomorrow for public comment. This is not the
occasion for editorial complaint, but really for questions.

MR. VIRGANO: My name is Dan Virgano. I\'m with [USA Today]{.underline}.

CHAIRMAN KASS: Could you speak up better or could we get the microphone
a little \--

MR. VIRGANO: My name is Dan Virgano. I\'m with [USA Today]{.underline}.

CHAIRMAN KASS: Thank you.

MR. VIRGANO: What I\'m wondering is did any of the Council members
change their original opinions or notions about this topic as a result
of this process.

CHAIRMAN KASS: This has been a roller coaster of a conversation. I mean,
there are some people who probably remain at the end where they were at
the beginning, and other people have wrestled very hard and, as best I
can tell, may have changed their minds certainly if not exactly about
the morality of the question, at least about the right way that we
should proceed as a society.

But it seems to me personal confessions might be in order if you want to
buttonhole people around the table, but, no, I think from where I sit it
seems to me there has been some movement in some places, and we\'re not
all simply dug in where we began.

And certainly there has been movement in which the power of the other
point of view has been clearly recognized in ways in which the heated
debate in Congress and other places rarely does. So that, I think, is
certainly movement.

MR. VIRGANO: Thank you.

CHAIRMAN KASS: Thank you.

Please, Mr. Palca.

MR. PALCA: I\'m Joe Palca from National Public Radio.

My question is if at least half the Council and possibly more favor this
four-year moratorium where people can work out the proper regulations
that would make cloning for biomedical research ethically acceptable or
at least done in an ethical manner, who do you recommend derive those
regulations?

I mean, are you stepping out of the discussion now and saying others
should do it, or are you saying we will continue and come up with what
we feel are a set of ethical guidelines?

CHAIRMAN KASS: No. Thank you very much.

First, I\'ll just correct the facts. I mean, the ten-member majority
group that favors a temporary ban on all human cloning, a four-year
moratorium on all human cloning, comprises individuals who, as you heard
from Gil Meilaender, would like to use those four years to persuade Paul
McHugh (a) that this product is really an embryo and shouldn\'t be used.

There are others who see this not as a down time, but as an opportunity
not just to devise the regulations for this, but to locate this in the
larger context the way the Canadians have and the way the British have,
and to think through this entire area.

This Council has been created with a lifetime of two years by executive
order. We go out of business at the end of November of 2003.

We have already begun our discussion of regulation in this whole area,
and not just about human cloning in particular. Frank Fukuyama has taken
the lead with his book [The Post-Human Future]{.underline} to call for
such things. We\'ve had several sessions on them. We will have more.

And we will give our best thought to suggestions for either
supplementing the regulatory mechanisms that now exist or if we have
anything useful to suggest to talk about others, we stand ready to
participate in this process.

But we are an advisory body with no decision making authority, and it
seems at least to some of us that what this area needs is a
consideration that goes beyond mere safety and efficacy, but to some of
the deeper moral questions that we\'re considering and to be able to do
so in some kind of an effective way, issue regulations, and enforce
them.

At the moment we have, it seems to me, a very partial solution, and
that\'s why we were very interested in the last meeting to learn
something about what\'s being done in other countries. We will continue
to do so, but mindful of the differences between the United States and
other places.

But thank you very much.

Ms. Stulberg, please.

MS. STULBERG: Hi. I\'m Sheryl Stulberg from [The New York
Times]{.underline}.

I have three very simple questions. First, why four years?

Second, it appears that Professor Carter didn\'t vote, and I wanted to
know why not.

And third, have you been asked or do you intend to present this report
in any way to Congress?

CHAIRMAN KASS: Thank you.

Four is a number less than some wanted and more than others wanted.

Professor Carter has not been able to make any meetings since, I believe
\-- I think he was there part of the February meeting. He was not
present with us in April. He was not present with us in June, and he has
been unable to comment and, therefore, has chosen not to participate in
this report.

It\'s not correct to say that he\'s abstained. It is, I think, more
correct to say that he has just not participated in this report. We
regret that very much.

And we are responsible to the President. And late last night \-- we just
got these copies yesterday \-- late last night a copy was delivered to
the President. We will be glad, I think, to make copies available to
members of Congress, but there aren\'t at the moment immediate plans for
such distribution.

Thank you.

Ms. Meckler, welcome.

MS. MECKLER: Hi. Laura Meckler from the Associated Press.

My question is you\'ve said that you hope that this report outlines the
arguments, the powerful arguments, on both sides of the issue.

CHAIRMAN KASS: Right.

MS. MECKLER: From a practical point of view, as Congress and, more
particularly, the Senate is grappling with this issue, what specifically
do you see them doing with this report?

Obviously, one thing that may happen is people will use the arguments
that they like to reinforce their points of view. Do you see anything
beyond that? Do you think this will change people\'s minds? Do you think
the majority opinion, albeit a small majority, will carry some weight
with those who might be undecided?

Could you just talk about the practical impact?

CHAIRMAN KASS: Well, the truth is it is not for this body to hazard many
guesses as to what other people are going to make of it. The Senate is a
large, powerful, independent body, and you\'d, I think, probably have to
give them time and ask them what they will say.

I would say only two things. If somebody reads carefully, they will see
that the two proposals that have come from this Council are neither of
them explicitly represented in the alternatives that are present before
the Senate. The more permissive proposal does not call for the prior
establishment of strict regulations, and if you look at the document,
what the minority is calling for are things that are really quite, quite
strict and extensive.

And I commend you to Chapter 8 for the details.

The majority recommendation calls for not a permanent ban, but calls for
a permanent ban on cloning to produce children, but a four-year ban on
all human cloning so that this debate can continue, so that those who
want to seek for regulations can do so, so that there will actually be
an incentive for people to continue to carry on this conversation
because the green light will not have been given.

Some of the members of the Council \-- this political debate was
swirling around us all the time we were working. It made life
interesting, but we tried to follow our own line on this, not to be
unduly influenced by what was there.

On the other hand, at least some of us have been distressed or at least
concerned that after much public debate both in 1998 and in the current
session of Congress, that the result might be simple acquiescence in
whatever Dr. Antinori and other people do, and that we regard that as
regrettable.

If the Senate would be interested in adopting this proposal, you\'ll
have to ask them, but it might be a way past this impasse.

Please.

MS. BOYCE: Hi. I\'m Nell Boyce with [U.S. News & World
Report]{.underline}.

I wondered if the panel, those who were in favor of a moratorium in
terms of giving time to produce adequate regulation and oversight over
research use of cloning, if they considered or it was discussed what
impact it might have if one of these groups working on human cloning for
children actually came forward with a successful birth of a child
through somatic cell nuclear transfer.

I wondered. You know, four years is a long time, and I wondered if that
was something that was discussed in terms of giving this time period to
develop regulation.

Yeah, I think I\'m speaking fairly that we were not \-- the time wasn\'t
somehow dictated by the chances of a successful creation of a cloned
child. In fact, the Council, I repeat, is unanimous in recommending that
this be proscribed permanently.

And everybody understands that even permanent bans \-- permanent bans,
first of all, can be altered. One can revoke them. And permanent bans do
not prevent rogues from violating them, but they can\'t violate them
with impunity and certainly they can\'t violate them and be praised by
the community that regards this as a deep violation of the moral norms.

So I don\'t think the call for the moratorium of four years was somehow
affected by what Dr. Antinori or Dr. Zavos might be planning, but rather
by, as you\'ve heard around the table, the believe that there\'s an
important moral boundary here to be crossed, and that we need time to
debate that thoroughly to decide whether we should cross it, and if so,
what the costs are both of crossing it and of not crossing it.

One last question, please, and then we will take a break.

MS. LEONARD: Hi. I\'m Mary Leonard with the [Boston Globe]{.underline}.

CHAIRMAN KASS: Hello, Ms. Leonard.

MS. LEONARD: The position that you\'ve laid out today is not President
Bush\'s position. You said the report has been delivered to him. I
wonder, first of all, if you had had any conversations with the
President about this; whether you will be urging him to adopt this
position and, I suppose, whether you\'re prepared for him to reject your
recommendation.

CHAIRMAN KASS: Well, thank you very much for that question.

No, I have not discussed this with the President. I will not be urging
this on the President. He has the reflections and recommendations of
this Council, and I\'m confident that he is a man who will consider the
various issues and reach his own conclusions, as he has done on so many
occasions before.

The only one thing I would correct slightly. I\'m not sure it\'s fair to
say that the majority of the recommendation is not the President\'s
position. It\'s not the President\'s position, if I understand it, that
called for a permanent ban on this, but it does not somehow violate.

If it were given effect, namely, that there would be no human cloning of
any kind for a time, I\'m not sure that that is a contradiction of the
President\'s position, but I think I\'d have to leave it to the
President and his spokes people to answer for themselves.

Thank you all very much. We are adjourned until a quarter of 11, when we
will return to discuss the patenting of human organisms.

(Whereupon, the foregoing matter went off the record at 10:22 a.m. and
went back on the record at 10:55 a.m.)

CHAIRMAN KASS: On the record. Would Council members please return to
their so that we can get started. All right. This is the Council\'s
third session on the topic of patenting human organisms on which we had
two sessions at the last meeting and from which the staff has prepared a
working paper in your briefing book.

Just to review the bidding at the June meeting what we began to explore
the potential problem of the patenting of human organisms and we had
five guest presenters who tried to provide us with a sense of the issues
at stake, the history, the state of the present law, the interests and
needs of the biotech industry and the moral questions surrounding the
matter.

The factual questions for us is this argument organizations, patentable
subject matter under the terms of the U.S. Patent Code as interpreted by
the courts and the applicable question is should they be. According to
staff\'s understanding of what happened at the last meeting was that it
looks as follows: under the present and in the light of several
important court decisions over the past two decades there is no explicit
barrier to the patenting of the human organism; and that this is
troubling circumstance but any attempt to address it must take careful
note of the needs of the biotechnology industry and should not be a
backdoor effort to address the large moral issues raised by embryo
research, genetic manipulation and other morally charged developments in
biomedical science and technology.

The presenters all urged us to focus very narrowly any kind of inquiry
on the patent in question. Many of the people said that this was an
inappropriate way to get at those larger moral issues and one can
concur. But that seemed to imply that the Council\'s only interest in
taking up the question of patenting living organisms was in fact as a
backdoor means of getting at those other issues. The suggestion is that
this might not be true.

Patenting might not be the route to those questions but it is the only
route to answering the question of patenting human life itself which
might be a significant ethical concern of some real importance to us.
There is a moral aspect unique to the patenting question itself.

So the point of this meeting is to have a discussion amongst ourselves
to see how after several weeks of opportunity to think further about it
whether this is something that we think is important and important
enough to become some kind of Council project.

Do we want to include human organisms at whatever stage of life,
embryonic, fetal and child under the subject matters that might be
patentable? If so, why has there been a reluctance to do so? And to what
does this reluctance point? What could it teach us?

What would it mean to grant quasi-property rights patent protection over
human organisms over body or body parts? How does this relate to larger
concerns what some people expressed about the commodification of human
life? What does this actually say about the topic that we\'ll be
discussing tomorrow, the relation between ourselves and our bodies?
Patenting isn\'t the backdoor to these questions. It seems to lead to
them directly.

On the other hand, a biotech industry is a precious resource. The
patenting is a terribly important instrument for encouraging innovation
and any discussion that we would have about these matters has to keep
firmly in mind that this is something to be treasured. Any attempts even
to think about closing a loophole must keep the fundamental purpose of
patenting in mind which is not to regulate but in fact to assist and
encourage commerce and industry and the advancement of knowledge.

That by way of introduction and I simply was setting the table to see
where your thinking is on this question. Whether you think there is
something here of limited or perhaps not so limited scope that would
make sense for this Council to take up. The floor is open for your
comments and discussion.

PROF. DRESSER: Well, if no one else wants to jump in I will. I guess I
have a few thoughts on this although my head is still full of cloning. I
guess there are things I think to be said for taking it up and questions
I would have.

One reason to take it up is that my impression is that people who are
patent law scholars such as Professor Rai who was here with us before
and I think she is not the most extreme example. But there tends to be a
focus primarily on how should the patent law be designed so that
innovation can be stimulated. That is the concern that they have.

They don\'t really look at these broader ethical questions that we would
be addressing in a project like this. I heard an interesting
presentation in which someone was discussing this, Professor Boyle from
Duke Law School. He said that it\'s like the top of the bus and the
bottom of the bus. The scholars are up here talking about how do we
foster innovation. On the bottom of the bus I don\'t endorse this
hierarchy but there are democratic debates going on about what should be
patentable subject matter. And we\'re not talking to each other.

It\'s almost as though we speak in different languages. So I guess one
thing that we could contribute would be an attempt to try to bridge that
gap and to try to bring enough of the technical legal scholarship
together with more democratic concerns. There I think we would want to
try to get some good expertise in patent law scholarship because I
certainly don\'t consider myself an expert on that.

I guess a question I have is that I agree with Professor Rai and others
that a patent is a property right. It\'s only one of the many property
rights that exists. So is there a problem in treating patenting in
isolation so that if we were to say well it\'s wrong to grant patents on
human organisms wouldn\'t there still be a lot of other possible
property rights that we might worry about, types of ownership and
commodification. I think this leads to Michael Sandel\'s previous point
at the earlier meeting about the question of whether we should just
address the commodification more broadly.

Then I guess another question I have is if we were to do this I think we
would want to look not only at this question of human embryos and human
life at various stages but what is a human organism. If there\'s a
genetically modified creature how much of the human genome has to exist
for us to consider it a human organism that would be encompassed in any
policies that we might suggest?

CHAIRMAN KASS: Thank you very much. Let me make a suggestion. There were
about three or four meetings ago we decided not simply to do everything
in cue in the hope that actually we might discuss one topic at a time.
The group is also somewhat smaller. I\'m sorry about that but we are
somewhat smaller. Maybe we can actually discuss one topic at a time. Let
me try to keep order and then let\'s try to stay with one thing and see
if we can advance the ball.

Rebecca has given us at least three things to speak on: building stairs
on a bus; thinking about the relation between this property right and
other property rights and the questions of commodification on them; the
next question of all right if you wanted to say something about not
cloning human organisms and what exactly does that mean. Michael, could
I ask you to pick one of those things and whatever you pick we will
discuss.

PROF. SANDEL: That\'s a dangerous offer, Leon. I think we should take up
the question of patenting life but my question is whether we would do it
better if we took it up as part of a more general inquiry into the
commodification of life.

We found ourselves saying many times around the table over the past in
the cloning debate that in many ways we wish that we could address
cloning for biomedical research in the larger context of embryo
research. Many times we found ourselves frustrated that we hadn\'t taken
that broader view.

I think that we might learn from that experience here. I think that
might argue for taking up and I certainly think that\'s of importance
and it\'s of great moral and intellectual interest, the question of the
commodification of life in general. Patenting is troubling for reasons
that I think are very hard to distinguish from the same reasons that
make us worry about the commodifying life in other ways.

CHAIRMAN KASS: For example?

PROF. SANDEL: For example, the buying and selling of eggs, sperm,
fertilized eggs, stem cell lines, genes, commercially contracts for
surrogate motherhood. I think that if we simply focused on that aspect
of commodification or of property rights in life presented by patenting
in exploring the ethics of that we would be driven to analogous cases
about ownership of let\'s say in the sale of sperm and eggs or of
surrogacy contracts or owning genes and \--

CHAIRMAN KASS: Organs.

PROF. SANDEL: And organs. So if the moral arguments would naturally lead
to closely analogous cases of those kinds I think we might regret
restricting the bounds of our inquiry in advance. Now an inquiry into
commodification might take longer but I don\'t see that as an objection
to it.

I think ethically and intellectually the issues raised are similar I
think from the standpoint of focusing public discussion. It\'s as
important to focus public discussion on these areas as it is on patents.
So I\'m all for discussing and examining the patenting of life but I
don\'t see any compelling reason not to situate that in a larger inquiry
into the commodification of life though it may be there are
considerations I haven\'t thought about.

CHAIRMAN KASS: Mary Ann, to this. Please. Would you put the mike on
please?

PROF. GLENDON: I agree with Rebecca and Michael that we ought to look at
patenting in the context of the larger questions. But I want to throw
out another idea about what the larger questions might be whether it be
commodification which relates to the property is quite the right
category.

I think the patent language in the Constitution is a very interesting
intersection between science and commerce. That whole set of questions
about the relationship between science and commerce has been woven
through our discussions and concerns about cloning and is likely to be
woven through any subject that this Council might take up.

It was interesting for example to read in this morning\'s [Boston
Globe]{.underline} of Ellen Goodman\'s column commenting on the recent
controversy over the use of estrogen. It says that prescription of
estrogen over the years represented the triumph of market over science.
I think really that\'s the set of questions that we want to look at and
just a few more words about that.

We all agree around this table that free scientific research is of very
value, something that we want to encourage, that patenting language of
our Constitution wants to encourage. I think we all agree that the free
market has great advantages but that both the freedom of science and
freedom of the market somehow to work at their best have to be conducted
within a moral and juridical framework.

That\'s where the real hard questions are. Where does the moral
framework come from? Internally? Self-regulation? Formation of citizens?
Where does the juridical framework come from? That\'s really more in our
province and I think that\'s the context in which we should situate our
discussion of patenting.

PROF. SANDEL: Could I just ask as a follow-up?

CHAIRMAN KASS: Michael, please.

PROF. SANDEL: I find that persuasive. Could you say just a little more
about what in practical terms that focus which seems like a very good
focus how might we structure that discussion? Can you say a little bit
more about what you would have in mind?

PROF. GLENDON: Michael, I think that\'s just the sort of thing that
would take a period of preparing some papers and call some people in.
But I think that would be a good general question to start out with.
What should be the relationship between these two values that we pursue
and believe in but both of which need some kind of a framework in order
not to be self destructive. You can kill the geese that are laying those
golden eggs of scientific advance and productivity.

CHAIRMAN KASS: Directly to Mary Ann.

DR. ROWLEY: Yes, it\'s directly to a comment that she made though. It\'s
tangential to the discussion. I just want to point out your statement of
triumph of marketing over science.

You see what it really was was initial small scientific observations
made concern conclusions because heart disease doesn\'t really increase
dramatically until after menopause that estrogens might protect you from
heart disease and other things. It was only when larger studies were
done and good scientific data were obtained that it became clear that
there are both benefits and disadvantages to a hormone replacement
therapy.

So that good science, well done science on a large scale was what was
required to then clarify the good things for hormone replacement
therapies such as reduction of osteoporosis and the bad things such as
potential increase in heart disease and breast cancer. These are very
small increases proportionately over the general risk so you have to
have well done large studies in order to begin to get some of these
data.

CHAIRMAN KASS: Mary Ann please and then Gil.

PROF. GLENDON: The phrase wasn\'t mine but nevertheless I think there
are issues just on that particular problem that bear examination. Was
estrogen therapy oversold to women who really didn\'t need it and what
was the role of the drug companies? So it\'s again an intersection
between science and commerce that we don\'t very often look at as
closely as we ought to.

CHAIRMAN KASS: Gil and then Dan. I\'m just trying to keep us on track.

DR. FOSTER: I want to respond to Mary Ann. There\'s another thing and I
don\'t know these legal terms and I don\'t know whether commodification
is the same thing but you hinted about the effect of the market here and
we see it on all the advertisements on TV and everything for drugs right
now we\'ve talked about that in this conference before. I have a further
concern and I don\'t know whether it ought to be part of yours and
Michael\'s consideration but if you use the term you will understand
what I mean if it\'s correct or not.

There\'s a commodification of the scientists themselves which to me is
in many ways deeply regretful. There is a powerful incentive to make
money. I mean scientists didn\'t used to be too interested in money or
academic people. I remember when I decided to go into academic medicine
I told my wife when I decided to do that we\'re going to always be poor
but that\'s what I want to do. She said okay I\'m with you. But it
didn\'t turn out that I was always going to be poor because I make a
good salary and so forth.

But the emphasis, the commodification that I worry about is that the
power at least when the market was very high of making money in biotech
companies and so forth no doubt influenced not only what one worked on
which in one way is good. Many of the basic scientists are working on
clinical things when they wouldn\'t touch it before. But it\'s also
inhibiting.

For example often times there are restrictions that would allow the
graduate student or post doctorate fellow not to talk about the work
that is going on or you don\'t talk in the hall. It used to be when you
walked around the scientific institution people are jotting on boards in
the hall and I\'m happy to say that we still have a few boards at
Southwestern where we jot in the hall regardless of somebody owns a
company and I\'m in no company.

I have no restrictions. But I wonder if the commodification of
scientists itself might \-- I think there are ethical issues there that
we might want to talk not only about worrying about the market and other
things but that might be something that we might want to include in your
broader scope. The topic might be minor but I\'d like to talk about it.

CHAIRMAN KASS: Gil.

PROF. MEILAENDER: When I told my wife that I wanted to go into academic
life and teach ethics I said we will always be poor and by George
nothing has changed. (Laughter.)

DR. FOSTER: Now listen at this late time in your life, Gil, if you wish
to be admitted to a medical school class I will try to see what I can
do. (Laughter.)

PROF. MEILAENDER: Thank you. Back to the patenting thing, whether we
should proceed with this or not I don\'t know. I\'m not sure it\'s at
the very top of my list of questions to proceed with. Just thinking
about how one might proceed if one did, I grant that the commodification
issue is inevitably an important one there and the relation of commerce
and research is important.

But I must say that I\'m leery for a body like this beginning with some
kind of grand, large, philosophical starting point. If we start with
commodification, we can spend a long time reading an amazing body of
literature about the body and what it means to be embodied and so forth.
If we start with commerce we can all read [Tocqueville]{.underline} to
think about what a commercial republic is.

I think I might be more help to think about it if I started with
something very narrow and precise and then waited to see how these
larger questions which I agree are there came out of it. For instances
when I read the staff paper I realized that I never actually read
section 271(G) of this patent law.

I think I would be more help to have that section in front of me and a
proposed revision of that section by somebody who wanted to figure out a
way to control patenting of a human organism and then listen to a couple
lawyers argue about it. Perhaps a couple biotech researchers argue about
how it worked. Then I\'ll see what big questions do or do not emerge
from it. I know whether I think I have a very small project here that
doesn\'t require much more than a letter to the President saying the
Council has thought about this and recommends this or whether it
requires something more like a report. At least for me I would rather
start that way and see how the big questions fall out.

CHAIRMAN KASS: This is really methodological. You descent from the
importance of the large questions but you worry about whether it makes
sense for this body to tackle them in that global way.

PROF. MEILAENDER: Right. I make my living thinking about large
questions.

CHAIRMAN KASS: You make your non-living.

PROF. MEILAENDER: My non-living. My less-than-Foster living. But no I
don\'t know for a group like us if it will work very well to start big.

CHAIRMAN KASS: Frank.

PROF. FUKUYAMA: I\'m really with Gil on this. I think there were a lot
of practical issues revealed in the discussion at the last session on
patenting that really need some fairly nitty-gritty discussion. For
example, although I think that Professor Rai was correct in saying that
if you for example want a black band embryo cloning probably the best
way to go about it is just to band and not try to get at it through
patent law.

There is something a little bit disingenuous about that because she was
preceded by Mr. Holtzman who said well if we don\'t have property rights
in these procedures you\'re not going to have any of this product. So
obviously there\'s a relationship between whether the thing exists and
whether those property rights exist. One alternative path towards
regulating these activities is by controlling the property rights. It
doesn\'t get at the ethical issue. I mean there is an ethical issue of
commodification in addition but there also is a very important practical
significance.

The other thing that was quite clear from that discussion is that in
fact the patent and trademark office does get into a lot of ethical
issues where they have absolutely no institutional capacity for making
decisions. It was clear from that discussion for example that some of
their past decisions had amounted to asserting that life begins at
conception because I believe in the materials we were given it clearly
indicated that they had applied the rules about no ownership of human
beings to basically an embryo which I think would probably surprise a
lot of pro-choice people in this country that some patent lawyer tucked
away in a obscure bureaucracy and Washington have made this decision on
behalf of the American public.

It\'s just such a minor \-- It didn\'t get particularly politicized but
that\'s an important decision. It\'s very clear that as a particular
matter that whole institution needs to have some scrutiny but also I
would say put in the context of scrutiny of a lot of other institutions
that we have that control biomedicine.

CHAIRMAN KASS: Robby George.

PROF. GEORGE: Yes, thanks Leon. If we go into the issue there will be
good reasons to avoid making the issue simply replicate in large
measure, the debate of the moral status of embryonic human beings. There
will be a lot of pressure that we will apply to ourselves to avoid that.
At the same time for the reasons that Frank has articulated and others,
we will discover there will be in the end no avoiding that issue. The
issue won\'t perhaps dominate the discussion because there\'s a lot more
to the issue of commodification than the status of the embryo. But
that\'s a very important issue and I think it\'s going to be difficult
to avoid.

But I wonder if we will find ourselves bumping up against that issue and
against our disagreement on that issue and then constantly having to
pull ourselves back from it but pull ourselves back feeling quite
unsatisfied because in a certain way for the reasons Michael articulated
to engage the issue of commodification fully, we have to engage that
issue.

I guess there are lots of reasons we are going to eventually have to
engage that issue. I hope that eventually we will.

CHAIRMAN KASS: I shall take that as a friendly warning. (Laughter.)
Look. Let me try you out on this and let\'s shift from thinking about
the embryos to something that I doubt no one is going to make an
argument that an isolated organ is a human being. Right? One could
imagine that with certain kinds of genetic alterations that would be the
work of human art rather than of nature. In fact one has seen it with
mechanical organs.

One could imagine that one could find ways of altering fleshy organs as
opposed to mechanical ones such that they would come under the category
of patentable matter. I guess the question would be does one regard that
with equanimity or does one say that there is something here that one
wants to draw back on.

In other words, I\'m not sure that the issue about the patentability of
human organisms and let me add their parts is simply going to turn on
the vexed question of whether is one-cell creature is or is not a human
being. I\'m not arguing one way or the other. But Michael sent out a
list of a whole series of things that I don\'t think he was simply
trying to get us to avoid the focusing of all this but he believes that
that\'s the right domain.

PROF. GEORGE: Yes, I wasn\'t asserting that every issue is going to turn
on the moral status of the embryo. But I think that there are going to
be a number of issues that are central that will implicate the question
of the moral status of the embryo. And we\'re going to bump up against
them. Are we just going to draw back each time?

CHAIRMAN KASS: But my point was and I guess I didn\'t make my point that
just as one doesn\'t regard a human body part as a person so someone who
didn\'t regard an embryo as a person might still find it regrettable
that one is getting patents but doesn\'t necessarily turn on the
judgement about whether the embryo is a full person or not, whether one
thinks that this is an area that has an ethical dimension worthy of our
attention or not.

PROF. MEILAENDER: Leon, just could I intervene to say. I think you
should eliminate the full person language in your exchange with Robby. I
think that loads way too much. Use human being or something like that.

CHAIRMAN KASS: I accept the correction. It was loose speech. Do you want
to fix my sentence?

PROF. MEILAENDER: I would never try to do that.

CHAIRMAN KASS: Make my point for me here.

PROF. MEILAENDER: I don\'t think it\'s a point that I disagree with. But
I don\'t know if I want to make your point exactly. I think all Robby is
saying and I believe I agree with it is that at some point in discussing
this issue you\'re likely to end up talking about some things that the
staff paper I think calls human organisms. The question is going to be
what is their status.

CHAIRMAN KASS: Right.

PROF. GEORGE: And we\'re going to want to distinguish those things that
are not human organisms from those that are. While some people are going
to make undoubtedly arguments or at least will have concerns about
patenting even in cases where they don\'t believe that you have a human
organism in play. There will be others for whom that will be crucial and
the trajectory and content of their arguments will be affected by that
which I guess is just a long round-about way of saying let\'s do this.
Let\'s do it knowing that as with cloning we aren\'t going to be able to
simply separate out even if for other reasons it would be desirable to
the question of the status of the embryo, and please at some point let
us be the ones to lead or at least invite our fellow citizens into a
national debate about the moral status of the human embryo.

DR. KRAUTHAMMER: Could I make one point? I think you\'re right. You will
have people agreeing and disagreeing about the moral status of the
embryo but thereby for different reasons coming to the same conclusion
about how we ought to deal with the patenting of human organisms or
parts in the same way we this morning had people who disagreed about the
status of the embryo who came together on recommending what we ought to
do with cloning.

So I\'m not sure that it\'s going to be an impediment to reaching a
serious proposal conclusion recommendation that we can make. I think
you\'re right in highlighting that there\'s no getting away from this
conundrum but I\'m sure in the end it will stop us from achieving a good
result.

PROF. GEORGE: I agree with that. I think the parallel with what we\'ve
done in cloning is pretty close. I know that it would have been nice in
dealing with some important aspects of the cloning issue to be able to
get rid of the question of the embryo if it could have been laid aside.
It turned out that we were unable to do that. We can now understand why
we weren\'t able to do that and we\'ll be unable to do it I think when
we move on.

But, Charles, I\'m not making an argument for not moving on to this
issue. I guess I just want us to have in mind that we\'re going to bump
up against it as we did with cloning. But I hope at some point we\'ll
really confront it directly.

DR. KRAUTHAMMER: And I\'m hoping that we don\'t. (Laughter.)

CHAIRMAN KASS: I was going to say something but I think I\'ll let it
sit. Robby\'s point is at least taken and for the record it should be
noted that all parties to the discussion in the cloning report adverted
to, made use of, based arguments on some tacit or explicit views of the
status of the embryo.

We had many abortive attempts to discuss that amongst ourselves. It is
one of the large themes that is not thematically treated as a separate
section of its own in this report. It was one of the things that struck
me reading the whole report at the end. You dealt with procreation. We
dealt with meaning of healing. You dealt with science in society. But
there really wasn\'t some section with embryology and so on.

Maybe if we had that we might not have been able to finish but it will
come back insofar as we take up the question of embryonic stem cell
research. Without making any promises, let\'s at least keep in mind the
possibility of doing it better although I think it would also be very
nice for the short run to have a little respite.

I\'m speaking simply from the chair that we find some topic in which
that question doesn\'t get in the way of our making some progress on the
thing that mattered to all of us. Then I think lots of interesting
things could happen around the table. Mary Ann, was that a hand?

PROF. GLENDON: Yes.

CHAIRMAN KASS: Please.

PROF. GLENDON: Well some topics since I\'m a property teacher property
suggests itself because of the topic. Maybe the way to think about the
issues that Rebecca and Michael are raising and the patent is about the
question why it is that we assume that certain things can be owned. In
the history of property law over time, there has been great variation in
notions of what is a proper subject of ownership and what is not.

Also by the way I should say there have been great variations in what is
the constellation of rights that we call property rights. Property is
not a unitary thing. It\'s a bundle of rights. To have a patent on
something is not necessarily to have the whole bundle of rights that one
could possibly have. If you have a patent on a organism, it doesn\'t
mean necessarily that you own that organism for all purposes or that you
can do as we often say about property anything I want with it. That\'s
not really what property is about in any legal system.

But here\'s my concrete suggestion. There are more legal systems than
not in the world that view the human body as not a subject of property
rights and as not in commerce. I would think that if we are going to go
forward with this it would be very interesting and helpful for us to
have somebody from France or Germany, one of the Romano-Germanic systems
somebody who has served on one of their Bio-ethics commissions, come and
talk to us about what it means concretely as a practical matter to have
a legal system in which that idea of outside of commerce, outside of
property is deeply embedded and how they deal with all the problems that
modern science poses.

I would say that at the heart of our political philosophy there is a
problem. John Locke at the very heart of the chapter that is the heart
of his essay on liberty, the chapter on property, says his starting
point is that we own our own bodies. He just asserts it. He doesn\'t
have any argument. He just says we own our bodies.

That poses a problem for him and for us immediately because if you own
something, can you alienate it? Locke really never solved that problem.
He didn\'t want to say that we can alienate our body but he wasn\'t able
to really put together this idea that you can\'t really alienate your
body with the idea that you own it. But that idea of owning bodies which
is unique to the Anglo-Americans really bedeviled our legal system. So
I\'m suggesting that we take a look at how other legal systems approach
this.

CHAIRMAN KASS: Michael?

PROF. SANDEL: I like that idea very much. I think that whether we
undertake that or any broader inquiry we should in any case provide Gil
with section 271(G) which he can read during or after any of these
philosophical discussions. I think the idea of the human body and
commerce(?) might be one way of framing this.

It occurred to me thinking about this just as we\'ve been discussing
that one reason not to have a quickie narrowly focused study is and I
haven\'t followed in detail or as much as I should the Senate debate and
what Senator Brownback\'s fallback position is but as I understand he
has gone for a moratorium and then for some legislation on patenting.

I think there\'s the risk especially now since the Council has
recommended a moratorium and now we\'re going to do a quickie, small,
brief, narrowly-focused thing against patenting. It\'s really going to
look like we\'re doing what we are committed not to doing, taking our
agenda from a certain sector in the Senate and plugging ourselves into
that.

I think that\'s a further reason not to do this but as the report keeps
saying time and time again and I kept wondering why I kept reading very
small, brief, narrowly-focused and so on. For political reasons I think
it would be a bad idea.

I would just add to that the more fundamental reasons which are
intellectual ones and ones having to do with the character of the moral
inquiry. So I would very strongly urge that we adopt something like Mary
Ann\'s formulation just now, the human body and commerce or ethical
questions at the intersection commerce or science or commodification or
even as Gil put it the question of the moral implications of being
embodied cells and what implications that should have for policy and law
in patenting and in buying and selling of organs, bodies, so on rather
than the small, brief, narrowly-focused quickie.

CHAIRMAN KASS: Bill Hurlbut.

DR. HURLBUT: I basically want to ask a question of the legal experts
here. My understanding of the whole concept of patents is that the right
to make some commercial benefit from something. It does not hinge
primarily or exclusively on a patent but rather that patents are a way
of opening up the process of producing something.

In other words, if I have the history of this right, originally patents
were over technique for making a certain kind of leather and the idea
was that the technique itself would be made public in order to foster
alternatives and deeper uses of this as opposed to keeping it secret.
Don\'t we have in our society a right to not ownership of something but
commercialization of something that we just keep secret without having
to grant a patent in the first place?

PROF. GLENDON: Yes, as the people who came to our last meeting explained
if you want to speak very precisely about what it is that a patent gives
you it is the right to exclude others for a certain period of time from
the process that you patented. The Supreme Court of the United States
has said frequently that the right to exclude is the most important
stick in the bundle of rights that composes property rights.

But it\'s not the only stick. So to have that stick by virtue of a
patent doesn\'t mean again that you can do anything you want with what
you have. In other words, there is room for regulation.

DR. HURLBUT: And then the other side of it being that there is a
possibility for commercialization and commodification even in the
absence of a patent. Is that right?

PROF. GLENDON: Sure. All the patent does is give you the exclusive right
to exploit process that you have patented for a period of time. So in a
way it\'s a suspension of free market activity for the sake of another
value

CHAIRMAN KASS: Question. Gil has mentioned for taking case studies and
starting small not to do a quickie because he worries about our starting
a large stratosphere. Is that the top of the bus or the bottom of the
bus? I can\'t remember. It\'s the wrong metaphor but never mind.

Are there other areas that strike you as just Michael sent out and gave
us a list of things in which the question is property in the body and
its parts. Mary Ann refers to other legal systems where that is somehow
beyond the understanding of what can be followed. Are there other
specific aspects of this that one might cluster together and see if they
add up to something? Gil, do you have some thoughts for particulars?

PROF. MEILAENDER: See, I don\'t know if I\'m the person who is persuaded
that they cluster so much and that\'s partly why I suggested starting
where I did. We have a session tomorrow where we\'re going to talk about
possible future work for example. I was going to raise that somebody
needs to think about organ transplantation industry and the increasing
number of arguments being put forward for some kind of commercial
payment for organs because actually I think it has been for some time an
important issue and if you pay attention you will see that it\'s really
cycling back and there\'s a lot of attention on it.

Now there\'s an example of another issue that relates. I\'m just not
sure that the and I can be persuaded but I have to think about whether
the question about whether I ought to be able to arrange to have my
organs sold after I\'ve been in a car accident to benefit my heirs who
need, Dan, all the benefiting they can get. I\'m not sure how that
notion of selling organs from someone who\'s essentially a corpse
relates to the question about getting some kind of property right even
if it\'s only some of the sticks in the bundle, Mary Ann, in a human
organism.

Maybe it does. I\'m certainly open to being persuaded but I just don\'t
off the top of my head see how it does. That\'s why I would rather take
and I don\'t too much care what issue but if it were the patenting issue
I would rather start with that and then see what connections I made.

Even in some of the other things that Michael mentioned in this list
like surrogacy for instance, people who disapprove of surrogacy have
never been able really to agree on what the reason is. Some people think
it\'s more for reason. Some people think it\'s for another. So it\'s
hard to sort out. I guess yes it\'s interesting. I agree with that. And
if you were teaching a class where you had a semester to sort it all
through I think that you might proceed in one way. If on the other hand,
you were chairing a bioethics council which came together at most once a
month for a day and a half to think about something, I believe I would
start in a different way. That\'s all.

CHAIRMAN KASS: Janet.

DR. ROWLEY: I think there is an aspect of this discussion which is
probably a practical aspect that should be considered. If you look at
what is currently patented not patentable but patented related to
humans, their genes and their cell lines. Both of these have utility
both scientifically and commercially. They can be replicated so that you
can use them, you can give them to somebody else, that other person can
use it.

The hypothetical question you were posing about taking an organ and
modifying it in some way so that it might be different as you were
discussing this I was trying to think well then it\'s a unique process
that you\'ve done unless it was a process that could be widely
applicable to all sorts of organs. The heart for example you did
something unique to it that made it more useful, made it less subject to
rejection for example.

Again coming back to something that I think Mary Ann was saying you can
patent the process by which you make that organ more universally
acceptable, you aren\'t actually patenting the heart itself. So I think
that we should at least keep some of the perspective in mind as we
discuss this issue.

CHAIRMAN KASS: Yes, that\'s very helpful. Thank you. Mike.

PROF. SANDEL: Here\'s one possible practical suggestion. We had a
session late in our discussion of cloning for biomedical research where
we invited people who could tell us about the experience in other
countries. As it turns out in most of those other countries they did
deal with the broader question of embryo research rather than cloning
specifically.

Could we may be have a session along the lines that Mary Ann suggested
where we would have people tell us about how other legal systems and
regulatory systems deal with the question of commerce on the human body
including patent law but not limited to patent law or other regulatory
aspects. Then on the basis of such a session try to figure out whether
we had a workable topic or one that we might define.

CHAIRMAN KASS: Comments to that? Whatever we do on this, the purpose of
this meeting was not necessarily to lead to the conclusion yes we should
or should not do something right away on this but to see whether there
is interest here. Even if there was enough interest to say this is
important subject but it may not be important enough given the other
things that are competing for attention from us and we\'ll be talking
about that tomorrow.

It seems to me fairly clear that if we wanted to pursue this some
additional work behind the scenes has to be done by way of inviting in
some outside consultants to enlighten us on one or another of the larger
aspects of this the way we did get some help on the narrower question of
the patenting last night.

It might also would be good and maybe we can work this out by the end of
tomorrow if the people on the Council who have a special interest either
in the science-commerce end of this or the commerce-body end of this
might constitute themselves a small working group.

It\'s true, Gil, that we come together once a month or six weeks or so
for a day and a half. And you\'ve given very generously of our time in
the interstices. We can\'t demand very much more of this body than you
are already giving.

On the other hand there is no reason why if there\'s real interest that
that interest occupies three or four people only the staff and the group
as a whole thought this was sufficiently worthwhile to allow some of us
to explore and bring back to the group we could provide some staff help
and support to that. So not everything has to be done always in the
plenary the way we\'ve tackled this. So unless there are some more
substantive things. Charles?

DR. KRAUTHAMMER: I would just like to make one practical suggestion from
what Michael had said.

CHAIRMAN KASS: Please do.

DR. KRAUTHAMMER: I seems to me that the question of patenting the human
organism is a subset of commerce of the human body which I think is a
very interesting subject. Another subset is the sale of organs which is
a very eminent practical and I think pressing issue. So perhaps we could
address the larger issue of the commerce and the body by starting with a
look at the sale of human organs. Then we can see whether we get a
two-fer out of it by having principles or ideas deriving from that
subject that would apply to patenting of the human organ.

CHAIRMAN KASS: I\'m not sure we can plate this out for the morning but
how should I read this looks of silence? Fatigue? Hunger? Are there
enough people here who think that there is topic not necessarily to put
as a definite topic for us but to keep in mind as we go to work tomorrow
and that we really need to do is some strategic thinking about how it
should be framed.

I myself like the possibility of juxtaposing say a concrete matter on
the sale of organs and the concrete question of the patenting as two
ways and maybe the thing that concerned Paul McHugh in the comments this
morning that has concerned Rebecca about the egg donors who are paid for
their services but not for their eggs that is to say the way commerce
functions in that area as well.

But maybe there are three mini-pieces of something but then it becomes a
very large project to be done right. I think some kind of help from how
other people think about this legally and ethically would also be
useful.

It is with all due respect, Robby, not just the body. Gil in his early
paper that he wrote for us when he talked about some of the large themes
of bioethics raised up the question of embodiment and the question of
the relationship between embodiment and identity. That is one of the
relatively neglected topics in the field of bioethics commerce or no
commerce and what is moving body parts around.

I don\'t want to speak for Mike in his absence but I listen to him on
some occasions. It sounds as if for him his identity is almost entirely
cerebral and the rest is an apparatus that enables it to work. I don\'t
mean to defend this. It\'s a distinguished pedigree to that idea, very
distinguished. Yet here we are with hunger and we\'re in doubt a
respiratory system that is so designed so that one can in fact be the
rationale animal and speak with one breath.

DR. FOSTER: Mr. Chairman, I don\'t want to interrupt you but let me make
a couple of suggestions. I\'m just going to suggest that we adjourn. I
think we\'re in post traumatic shock from this morning. Secondly I do
think there is an important issue for tomorrow about the priorities of
things. For example, I believe that the natural movement would be to
move from the cloning debate into gene therapy debate and particularly
the more dangerous issue in my view that we have to discuss of germ cell
therapy. Somatic gene therapy is an entirely different thing.

But my view would be although I\'m very intrigued by this and I don\'t
mind moving that into the next place because you could do it that we
could decide tomorrow because I do believe that the natural sequence
would be into moving into gene therapy.  There\'s where the enhancement
and all those things are going to become so much more important. We will
hear about more of that this afternoon with support. So my motion for
you, Mr. Chairman, is that we now adjourn for lunch.

CHAIRMAN KASS: I will do that only after the two guys who have had their
hands up.

DR. FOSTER: I believe that my motion trumps if I want to call for \-- No
I\'m kidding. Go ahead.

CHAIRMAN KASS: We will exhort that the last two commentators take less
than a minute or two. Bill and Gil and then we will adjourn.

DR. HURLBUT: Well, it\'s an odd moment to make a comment after that. I
just wanted to point out that what Janet said about process versus
product is very important but the strange thing about all this is that
now we\'re moving into the regime where organismal processed in a way
are becoming patentable products. That I think we are going to have to
confront. This relates to what Robby brought up but it relates more
broadly to the issue of commodification of human beings and their
embodiment.

We are going to have to confront the question that was a little less
complicated in past generations where it was parts apart from wholes.
Now we\'re going to have to confront the question of partial generative
potential apart from full organismal generative potential and that makes
it somewhat more complicated and brings us close into the question of
whether there is something about the human organismal process that is
different in quality than the small significance that other organismal
processes.

CHAIRMAN KASS: Gil, do you still want to speak?

PROF. MEILAENDER: Yes, although I hate to do it when someone has
mentioned lunch. This may simply reflect my own lack of knowledge in a
way but I just want to say again or ask again with respect to the
patenting issue. I came away from our session last time thinking that at
least for people who work on patent law which has a very long developed
history in this country it\'s a realm from which moral considerations
are largely excluded.

It is quite technical in certain ways. Therefore it\'s hard to figure
out how to drag into it these larger sorts of questions. That\'s really
been the source of my reluctance of lumping issues here. I just wonder
if it\'s not a sufficiently different issue because of that long
technical and somewhat amoral history that makes it to some degree a
world unto itself and little less able to be lumped into some larger
circle. That may just be ignorance but I just wanted to make that clear
once more.

CHAIRMAN KASS: Thank you very much. I remind Council members that owing
to the exigencies of Dr. Wendy Baldwin\'s schedule we have to start at
1:00 p.m. Please as a courtesy to our guest be back promptly at 1:00
p.m. She will be speaking to us about the NIH implementation of the stem
cell policy. The meeting is adjourned.

(Whereupon, at 11:55 a.m., the above-entitled matter recessed to
reconvene at 1:05 p.m. the same day.)

CHAIRMAN KASS: On the record. Thank you very much. I think we should
start. We have a couple of stragglers, Dr. Baldwin. There are always a
couple of stragglers. I think since your schedule is tight we should get
moving.

It\'s a great pleasure to welcome Dr. Wendy Baldwin who is the Deputy
Director for Extramural Research in the Office of the Director of NIH.
And who after President Bush announced his decision on stem cell
research, he was finished and she was not. She has come to talk to us
about the implementation of the President\'s policy on stem cell
research. We\'ve been looking forward to learning exactly what\'s
happening. It\'s very good of you to come and join us and educate us
this afternoon. Thank you.

DR. BALDWIN: Thank you, Dr. Kass. I\'m very happy to be here and to tell
you how I\'ve been keeping myself busy in implementing this policy. Let
me go through a little bit. I don\'t have handouts of the overheads, but
I\'d be happy to leave the overheads if you\'d like. I don\'t think I
have to go into much detail with this group certainly about what the
embryonic stem cells are, their unique properties, their ability to
proliferate, and the capability of forming other kinds of cells. So that
has importance for basic science understanding of what cells do as well
as our anticipation of clinical application as well.

There are many areas that we feel are major questions for us to think
about where stem cells are going to influence how biology is done and
what the importance will be. Our major activity right now has been to
implement the policy that was put in place last August 9th. So the
criteria for allowing research with federal funding on human ES cells is
shown on this slide. I think we\'re probably all familiar with this.

They had to have been derived from a blastocyst that was initiated prior
to the President announcing his policy. The embryo had to have been
created for reproductive purposes and no longer needed which means it
came basically from IVF clinics. There had to be informed consent from
the donors to use these cells with no financial inducement for the
donation.

The way we\'re implementing this is that having established these
criteria our first job was to complete the documentation and ensure that
we had documentation, that the available lines met these criteria, and
then to post a registry. Once we did that then an investigator could go
to the registry and identify a line that they wanted to use knowing that
it met the President\'s policy. So this is front-loading if you will
that review process.

On November 7, 2001, we published the NIH Registry. I\'ve given you
minimal handouts. You must have 150 pounds of paper to carry back with
you. Your handout from me is one single sheet of paper, two-sided. On
the front, it shows you the registry. On the back, it shows the stem
cell site on the NIH website that has every conceivable document. People
are looking around like they don\'t have it. Do they have it?

CHAIRMAN KASS: I\'m afraid there\'s been a slip up.

DR. BALDWIN: We will get it to you.

CHAIRMAN KASS: Does anyone have these?

DR. BALDWIN: It\'s a page.

CHAIRMAN KASS: They\'re coming right now.

DR. BALDWIN: Once you go to the stem cell section of the NIH website,
basically all of our documentation, information, *et cetera* is there
and is updated regularly. It took us a little while to get the registry
up. We wanted to be sure that we had developed it in a way that would be
user-friendly and that we had unique codes for the different stem cell
lines. It went up November 7th. Then what we did was we started to put
in place the things that would be needed for investigators to make use
of the registry and actually obtain funding to do this research.

The first thing we did was to realize that we had amissed the posting of
the registry so that people could come in for our October 1 receipt
date. NIH has three rounds of application receipts. So what we did is
extended that receipt date so that anyone who was sitting there poised
to do this research still had an opportunity to get an application in.

We then moved on to issue and announcement for Infrastructure Awards so
that we could reach out to the sources so we could help them be sure
they were actually going to be able to provide stem cells for the
researchers who wanted them. We moved on to Administrative Supplements.
I\'ll go into these in a little more detail, but it shows you how almost
week by week we were putting in place one or another element that was
necessary for us to actually fully implement this policy and make it a
reality for the research community.

So Administrative Supplements, Training Potential, all of these pieces.
The implementation job was really taking the policy and then saying what
are all of the different steps that have to happen to make this actually
really work. Let me go back to that one in a minute.

The last one on there is we announced the procedures for how you could
use the process that\'s in place for having research done on human
embryonic germ cells. In May 20th, we had the first review of such an
application. That\'s the companion to the embryonic stem cell
activities.

As of July 5th when the slide was done, we had made five of these
Infrastructure Awards, 13 Administrative Supplements, and one Grant
Award. That I think people can look at and say one award. How can this
be? But there actually is a fair amount of time that takes place between
submitting an application to us, going to scientific review, going to an
advisory council, and an actual funding decision made, and an award
made.

What you\'re hearing here is our taking that policy and mainstreaming it
in to how NIH does business. We have very sound principles as to how we
do business of transparency and peer review. We\'re bringing stem cell
research into that process. At the same time where we\'ve identified
what might be a gap or a hurdle or an impediment, we\'re trying to reach
out to that as well whether it\'s a need for training or a need for
infrastructure support.

A few features of this registry. We are listing all of the cells that
meet these criteria. You may be interested to know that we\'ve added
lines since the President\'s statement because we found six additional
lines that met these criteria. The registry serves two very important
functions. It provides a code for each of these and provides the contact
information because an investigator that wants to do this research goes
to the registry, identifies a line, and then gets in touch with them.

This is the content of the registry. When you go to each one, this is
what it looks like if you go to it on the web. You can\'t read that on
the screen. When you click on any one of these sources, you go to a
slash screen that\'s for that particular source. This one happens to be
WARF. You\'ll see that it gives you contact information, e-mail
information, their website, and the information about the cell lines
that are on there. That is information we\'re asking the sources to keep
up and keep current because it is their information.

What have we found to be the issues for researchers? Well, first is the
simple access to the line. Are there intellectual property issues, IRB
issues, administrative ones, and ones relative to how they\'re going to
actually get the skills to work with these lines? Let me take these one
at a time.

There have been questions as to whether these cell lines are actually
available. I think it\'s important to realize that human embryonic stem
cell work is relatively new. Because this was not an area available for
federal funding prior to the President\'s statement, they are largely in
foreign sources or commercial entities. So many of these groups were not
at the outset thinking about supplying the scientific community. That\'s
why we put infrastructure support out there, so that each of the sources
can come to us and apply for funding to help them scale up, better
characterize their cells, and make them available.

These are the awards that we\'ve already made. (Indicating.) It\'s on a
rolling receipt date though. It\'s something that we\'ll continue to do
as long as we have sources that need infrastructure support in order to
make their lines available.

There are of course many things that can affect easy access to these
lines. In some cases, we have international issues. There\'s been a
change in terms of whether biologic material can be shipped on a
passenger airplane. I can\'t sit here and tell you that it\'s all
simple. This is not Amazon.com where you can just click on it and it
comes by FedEx the next day. There are things your investigators have to
do in order to get access. They\'re not qualitatively different from
other fields, but they are important in this case.

All of these lines have intellectual property issues associated with
them. As I said by enlarge they are either commercial sources or they
are foreign sources. There is a U.S. patent on the derivation method. In
fact, the sources have to work out their intellectual property
agreements in order to make them available.

NIH did something that\'s a little unusual here. We of course would have
to negotiate a memo of understanding for our investigators to have
access to these lines. We did the first one with Wisconsin with WARF.
What they said was not only would these terms be available to the NIH
investigators but they would make them available to other investigators.

That\'s important to realize because the NIH doesn\'t get involved in
the negotiations between a source and a user. That\'s their
responsibility. But what this has done is made it much easier. In fact,
you can go to the website. Those memos of understanding are all on the
website. An investigator can just download that, click on it, read it,
take it to their tech transfer office, and if they can accept the terms
which are pretty straight forward, they\'re ready. They don\'t have to
negotiate this from the ground up as it were.

We now have four of the MOUs that are available on the website. I\'m
walking you through each of these steps because I think it\'s important
to understand the different pieces of this puzzle that had to be put in
place so that this whole area of research would actually take off. Some
of these sources may initially want to start out doing collaborative
arrangements, and others are further along in their development and are
more ready to make them just generally available. That was clear at the
outset that we would have that kind of variability.

This is the flip side of the handout which is the stem cell information
site which is absolutely essential if you\'re interested in this area of
research. On it, you will see all of the MOUs are there. We run a
Frequently Asked Questions section. We update that as soon as we have
anything new to put out there. Background reports, background material,
anything a potential investigator or a funded investigator would want to
know. We\'re trying to make it one stop shopping so that it is all out
there and pretty easily accessible.

In terms of IRB issues, all of these lines had documented informed
consent for the donation of the embryo. One of the follow-on issues
though was do any of these lines include identifiable information or not
or are they completely anonymized. We worked with the Office of Human
Research Protections to clarify the guidance about when IRB review is
needed if there is identifiable information anywhere. In fact, this
document which of course again is on the website clarifies that there
can be a firewall, either it\'s anonymized or the person receiving the
line has no potential to get access to any identifying information then
that streamlines what they would have to do within their own
institution. OHRP, we would not be requiring IRB review of the use of
that line. Grantee institutions may of course have some additional
requirements.

There were questions raised about administrative issues in terms of how
to think about the facilities and administrative costs if there were
eligible research and ineligible research going on to the same
institution. Again, we felt that there are already very strong and
existing policies about unallowable research. The institutions know how
to handle financially unallowable research. Basically this just
clarified for them how to do that, again to mainstream how this issue is
handled relative to other areas of unallowable activity.

We have this as an administrative issue. I\'m not sure that it is. Most
research when it comes in it goes through peer review. Reviewers are
really looking for preliminary data. In a new field, that\'s
particularly challenging. If it\'s a brand new field, you may not have
preliminary data.

We\'ve taken two tacks there. One is to now just have Administrative
Supplements available, but to really go a little further step to
advertise their availability. What that means is if you\'re already a
funded investigator and let\'s say you\'re working on mouse ES cells and
within the basic scope of the research you could add on some work in
human ES cells, you can come to the NIH for an Administrative
Supplement. They\'re modest in dollar support, about \$50,000. They\'re
handled administratively. But it is a way for probably our most
promising cadre of investigators to get started in this field and be
able to help develop some preliminary data. We\'ve also tried to deal
with that at the stage of review in terms of reminding people that this
is an area where it\'s much more difficult to have preliminary data when
you first come in.

One of the difficult issues for us is these are not necessarily easy
cells to work with. We\'ve looked at what the need is there. Everyone
who has worked with human ES cells has pointed out the need for very
careful, meticulous laboratory work and that there\'s a high degree of
variability across labs and culture conditions. So again, we\'ve looked
at what would be the tools that we could put out there to help
investigators develop those skills.

In some cases, they will get them through the acquisition process. So a
source might package some training along with acquiring the cells from
them. If you go to them in return for the price of getting the cells,
you would also get a couple of days of on-site training for maybe your
Senior Lab Technician. But we\'re trying to look broadly at that. We
have an announcement so that an individual investigator who really wants
to specialize in this area could come in and apply for funding or an
institution that wants to focus on doing some short term training
activities that they would make available to others could apply to us
for support.

Again, this is really taking the tools that we already have. We already
know how to work with a community to build skills when it\'s necessary.
We\'re just focusing them and applying them to this particular area of
science.

The information has been very widely disseminated. Now, we think it\'s
been widely disseminated. Just because we think it\'s widely
disseminated doesn\'t necessarily mean that it is. I get 350,000 or
400,000 hits a month on my website where this is located. We get more on
the NIH website. You can access it right from the nih.gov site.

We know some professional associations have been pulling up those
Frequently Asked Questions and sending them back out to their
constituencies. One of the things you can certainly help me with is if
you can think of any other strategies that we might use to make this
information widely available. That appears to do it. I wanted to go
through that fairly quickly so that you would have a chance in my time
here to ask questions. If anything that I\'ve gone through was either
too quick or didn\'t make sense, please ask me now.

CHAIRMAN KASS: Dan Foster and then Janet.

DR. FOSTER: I don\'t work on stem cells. One of questions I think fairly
broadly asked in the scientific community regarding the research is
given now the 80 cell lines, how many of those are in some sense
adequately characterized to be useful in research. You know much better
than I do, there\'s been considerable skepticism about the adequacy of
these cell lines for the research that we want to do.

DR. BALDWIN: Well, it\'s a little difficult to give an exact number.
It\'s certainly in excess of two dozen on there and are pretty well
characterized and we know they\'re available. I understand the question.
I understand the concern.

I think that we\'re equally concerned to see that investigators do get
started working with the lines that are available. That\'s going to be
the best test of how good those lines are. We won\'t know until people
use them and test them and compare two lines from different
laboratories.

There\'s a tremendous amount of basic work that simply has not been
done. While that\'s certainly an interesting issue to pursue, I\'m at
the implementation side. I\'m asking are the grant applications coming
in. Are we funding it? Are we building up a base of knowledge about
those lines? I think we really have to do that.

DR. FOSTER: Well, I think that\'s probably the only answer you have. We
oftentimes say the only way you can answer these questions is to do the
experiments. We had been talking about that earlier today.

DR. BALDWIN: Exactly.

DR. FOSTER: I think just myself that you\'ve done a wonderful job on
this infrastructure so far.

CHAIRMAN KASS: Janet, would you like to begin?

DR. ROWLEY: Well, I\'d like to carry on with the first question that Dr.
Foster asked you. Backing up just a bit. Have you or have you in
conjunction with the sources come up with a set of standardized
procedures that you\'re going to do to characterize these lines? Is
everybody karyotyping their lines and doing some molecular analysis of
them and what kind of studies have they done for longevity of the lines,
*et cetera*?

DR. BALDWIN: First off, the next enhancement if you will of the registry
is to encourage our sources to provide additional data. The sources vary
as to how much information they have and how much they\'re posting on
those websites. To encourage them to go ahead and site either their
published articles or the research that\'s being done with their lines,
that\'s the area of enhancement that I\'m looking for next.

The next area I think will be for us to bring those sources together.
They really form a very unique network. It will be bringing them
together really as a group that I think would be most valuable, for them
to share their experiences as to the most valuable information or where
their information appears to be discordant. We\'ve just made those
awards within the last 60 days, so it\'s just a little early for that.
That would be the approach that I\'d be inclined to pursue.

DR. ROWLEY: In terms of the Infrastructure Awards that you have made to
individuals, you indicated in your very brief overview that you are
asking or providing financial support to the sources to do some things.

DR. BALDWIN: Exactly.

DR. ROWLEY: I guess the question is in your infrastructure grants is
there some commonality of information that you are hoping that they will
use that support for to provide answers to some of these questions. Or
is it just you have X number of cell lines and it costs X amount to do
something.

DR. BALDWIN: No. It\'s not that. But the first way that you phrased it,
I think it would leave the impression that we\'re saying here\'s a list
of things we want to see, do each of these with each line. We really
haven\'t done that. They have come forward, not just give us money and
we\'ll do more, but to say what they will do and that goes through peer
review to say is that an appropriate strategy and are they going to be
useful tests.

I guess my experience has been especially in a new field bringing those
investigators together so that four or five of them sit down and say
here\'s the way I\'m going to do this and here\'s the information that
would be valuable. Having them talk that out to drive it toward some
common sense of what is the most appropriate or the useful measures is
usually preferable to us saying at the outset the specific ones we want
to see.

I know that\'s a taste in preference. Some people like a little harder
edge at the outset. I guess my experience has been I prefer to draw some
of that out of our sources as opposed to imposing it on the outset. But
I understand your question.

DR. ROWLEY: You\'re aware of the article in Nature suggesting it be some
of the cell lines. Presumably all of these are grown on mouse feeder
cell layers or virtually, a number of the cell lines are grown on \--

DR. BALDWIN: Many, yes.

DR. ROWLEY: So that the possibility that there are mouse-human hybrids
is real. Those would obviously have limited or no usefulness for the
kinds of investigations that many people are interested in. I guess I\'m
a cytogeneticist, so the first thing we do for cell lines is karyotype
them.

DR. BALDWIN: Yes.

DR. ROWLEY: I would have thought that it would be an important early
parameter for the study section to have required that each one of the
grantees do.

DR. BALDWIN: It is. I think what you\'re raising to me may be one of the
things that we could do would be to extract from those Infrastructure
Awards a little more of the vision of what the sources are proposing to
do even in advance of them having the results and having the data to
post. Obviously the abstracts are available. But we haven\'t thought
about doing that as an extract to see where that common sense of the
group as to the most useful activities would be.

They have latitude under a grant application. It isn\'t that they\'re
locked into doing one thing. If six months from now it\'s clear there\'s
something valuable to do, they could add that to it. That would be a
very useful suggestion for this. I think I see something to go back and
do.

DR. ROWLEY: Okay. Let me just pursue two other aspects of this. I think
it\'s marvelous that in your dealings with the sources that you have
made arrangements for other investigators to get some of the same kinds
of expedited access to the lines under the memorandum of understanding.
I think that\'s marvelous because certainly these material transfer
agreements can be painful and to do each one for private investigators
is difficult.

You raised the question of cost. I wonder is there a fair variability.
It seemed to me that as we were approaching WARF it was several thousand
dollars to get a single cell line.

DR. BALDWIN: Because of the network of agreements really, I think
that\'s going to be pretty standardized, the \$5,000 for access. I\'m
talking about academic researchers not anyone who is accessing for
commercial purposes. Then you can\'t just download an MOU and go to
work. That\'s very different if you\'re setting out to develop them for
a commercial activity. My interest is here, what we can do for the basic
research community.

DR. ROWLEY: Now, also in dealing with WARF, the MTA did include
statements that any discoveries we make with those cell lines the
intellectual property reverts to WARF. I don\'t know whether in more
recent memorandum of understanding whether that\'s \--

DR. BALDWIN: (Off the microphone.)

DR. ROWLEY: Okay.

DR. BALDWIN: I don\'t think so. I could have brought you a whole
notebook of this material. But I don\'t think that\'s the case for the
academic researcher. Again, the MOU is downloadable.

CHAIRMAN KASS: Could I just ask a question because this is an important
question to lots of people? Could I have Janet ask the question again
and could I hear the answer again so I know what we\'ve just had?

DR. ROWLEY: Well, I was raising the question that it was my impression
that as we approached the Wisconsin Alumni Research Foundation that were
we to buy the cell line \--

CHAIRMAN KASS: Right.

DR. ROWLEY: Which is \$5,000 and we did research with it, any
intellectual discoveries that we made then became the property of WARF,
not of us. There are a lot of these MTAs that have what are called
pass-throughs. This was the question. Whether I was mis-remembering or
whether possibly your memorandum of understanding is maybe a bit
different than I recall from maybe four or five months ago because I
haven\'t paid attention to this recently.

DR. BALDWIN: I don\'t think that has changed in that time. I do have a
copy and I\'d be happy to leave it with you. I think you may be thinking
of when you\'re obtaining the cell lines for a commercial development.

DR. ROWLEY: No, because this is strictly university research. That\'s an
important issues as to whether as you are making new discoveries
they\'re your intellectual property or reverts in some way to the source
of the cell lines. The fact that\'s not part of this is I think
excellent. I assume that as people come in with R01s that the cost of
the cell lines and things can be included as costs within the grant.

DR. BALDWIN: Oh, absolutely.

CHAIRMAN KASS: Again, just for my clarification. I gather the answer to
that question is that reversion applies only if these things are sold to
commercial organizations and not to university researchers. Is that
right?

DR. BALDWIN: Yes.

CHAIRMAN KASS: Okay. Thank you. Janet, are you complete for now?

DR. ROWLEY: Yes.

CHAIRMAN KASS: Thank you. Rebecca Dresser.

PROF. DRESSER: I wanted to ask about a couple of things. First, I was
interested in how you decided about whether the informed consent
requirement had been made in some countries far away. Did you ask for
just some documentation or how did you approach that?

DR. BALDWIN: We had documentation from all of the sources. We also had
visits to a number of the sources. All of the sources at the time the
registry first posted had come and visited at the NIH, so we had
discussed these things with them specifically. We also have had visits
to many of these other labs. So it\'s not just a paper review. It\'s
primarily a case of them presenting the documentation which is always
the case. That\'s the heart of it. But we have gone further than that.

PROF. DRESSER: Right. I understand. The other thing I wanted to ask
about is a little bit off the track but I understand that Dr. Gearhart
recently got an award to work on stem cells from fetal tissue.

DR. BALDWIN: Right.

PROF. DRESSER: And that it went through a review process under the
earlier NIH guidelines for stem cells which applied to both embryonic
stem cells as well as fetal stem cells.

DR. BALDWIN: Yes.

PROF. DRESSER: So I understand that it went through a review process,
and all the very detailed requirements were met. I wondered if that was
the same review group that reviewed that protocol as the one that was
earlier put up during the prior Administration, the group the Janet
Rowley mentioned this morning.

DR. BALDWIN: You mean the composition of that review group.

PROF. DRESSER: Right.

DR. BALDWIN: No.

PROF. DRESSER: How did that work?

DR. BALDWIN: Let me explain what happened there. We had these guidelines
that covered both derivation from germ cells, from fetal tissue to
generate the embryonic germ cell lines and also for embryos. So the
expectation had always been there would be more interest in the
embryonic research at that point. A group had been put together, but it
had never actually met and functioned.

So when the President\'s policy came along that really superseded this
whole section on embryo research. So we rescinded that portion of the
guidelines. But the only rescinded that portion of the guidelines. We
left in place prohibited. We left in place the fetal tissue side of it.
Now we had a very different creature because we knew the scope of that
would be much narrower than was originally construed.

So we basically went back and rebuilt that process. I mean, we didn\'t
change any of the elements of review. We didn\'t change any of the
rigor. But we did make that an internal NIH review. Obviously dealing
with appropriate conflicts of interest so that there was actually
someone who would be on that group who would have been from the funding
institute. We had them absented from that review because of potential
conflict.

But we took that group which was very mixed in terms of their science
background, ethics background, *et cetera*, to review that proposal and
to align it with the guidelines that were in place. They did meet. That
was a public meeting. We announced that in the Federal Register. We did
approve that project.

That process only begins when there is an application ready to be
funded. So someone comes in, we knew the Diabetes Institute was ready to
make an award through their Beta Cell Consortium. That\'s what prompted
that meeting. It happens in conjunction with the Center for Scientific
Review Advisory Council meeting.

PROF. DRESSER: So is the group all then NIH employees?

DR. BALDWIN: Yes.

PROF. DRESSER: I mean, one of the things we\'re interested in is if
you\'re going to have review of some of these kinds of things who should
be on the group. I was just curious about that. So you see this group
more as going down the requirements and checking off to make sure
everything was done as opposed to making some sort of ethical judgement
about whether it\'s good enough to go forward.

DR. BALDWIN: Well, they\'re explicitly not to review the science again.

PROF. DRESSER: I understand that.

DR. BALDWIN: The science is reviewed on a separate track.

PROF. DRESSER: Right. So what is their role?

DR. BALDWIN: Their role is to in fact look at the requirements which
have many different components and to see whether the documentation
that\'s presented to us is consistent with the requirements that we\'ve
put out there. If you go back to your first question, it\'s really not
terribly different from the review that we\'ve done now on the materials
submitted on the embryonic stem cells where we basically had the
President\'s policy and it was our job which was in fact an NIH
staff-level review as to whether the documentation was appropriate.

PROF. DRESSER: Right.

DR. BALDWIN: We were trying to look for some parallelism there.

PROF. DRESSER: But the initial proposal when this was going to cover
both kinds of stem cells, I just know some people who I believe might
have been put on the earlier group. I know it wasn\'t all NIH. It was
more diverse.

DR. BALDWIN: Oh, no. Right.

PROF. DRESSER: So was that group seen more as making conceptual, ethical
judgements more than this one is?

DR. BALDWIN: That group really had a much larger task because that was
where we were envisioning prospective establishment of embryonic stem
cell lines.

PROF. DRESSER: Right.

DR. BALDWIN: So they were going to really be reviewing the proposals or
the strategies for developing those lines. With the President\'s
statement, that decision was made. No prospective work, only
retrospective. It\'s only those lines that meet these criteria fixed in
time and space. I think we felt from the beginning that was going to be
the much more challenging area and likely to be the volume of work would
come in from the embryonic side. But that was a judgement call on our
part to bring that a little more in parallelism with what we were doing
on the embryonic side.

PROF. DRESSER: Thank you.

CHAIRMAN KASS: Bill Hurlbut.

DR. HURLBUT: Apropos of that question in a slightly different
perspective. Are there provisions in the way things run now for opening
to new apparent embryonic-type pluripotent stem cells that aren\'t from
embryo sources? For example, suppose that something like Catherine
Verfaillie cells are shown to be truly pluripotent or maybe even
totipotent. Are there possible ways to review that which would allow new
lines to be admitted if they didn\'t come from embryonic sources, either
from above or below in the sense that by de-differentiating something
that was differentiated or producing something that was slightly
differentiated from below? Do you see what I\'m saying?

DR. BALDWIN: But de-differentiating from an adult cell is not covered by
this at all. Maybe I\'m not understanding your question.

DR. HURLBUT: One of the hopes is that you\'ll be able to take an adult
stem cell or maybe a somatic cell using the proper cytoplasmic factors
and bring it down to pluripotency.

DR. BALDWIN: But you could do that. That would not be covered by this
because you\'re not starting with an embryonic or a fetal line.

DR. HURLBUT: My point is there are going to be some potential ethical
questions around that, and they will be the equivalent of embryonic stem
cells in a certain sense. I know that they\'re sources not embryos, but
they\'re potential is what\'s also in question. Isn\'t it?

DR. BALDWIN: Well, that\'s \--

DR. HURLBUT: I mean, you or the current policies would not approve for
example the artificial creation of a zygote from above if you will. You
could add the cytoplasmic factors.

DR. BALDWIN: I understood your question as to whether there would be
specific requirements to generate an apparently pluripotent stem cell
line starting from an adult cell. We would not have coverage over that.
I think you\'re probably really asking other questions about what you
would do with that cell after you got it, perhaps.

DR. HURLBUT: Yes. I\'m trying to get at the moral question of whether
the current provision has possibilities for reviewing new creations that
are being worked on at this time.

CHAIRMAN KASS: Bill, I think if I understand what is here being
implemented is something that is tied specifically to these authorized
embryonic stem cell lines.

DR. BALDWIN: Right.

CHAIRMAN KASS: And that while there might be other things coming along
that give rise to all kinds of myriad questions, that\'s not the
bailiwick of this body. Am I misunderstanding?

DR. BALDWIN: No, you\'re absolutely correct.

DR. HURLBUT: So they were not principles put in place. It was the cell
lines only.

CHAIRMAN KASS: Yes. Here was for the first time authorization,
permission to go ahead with these lines. Nothing was in place to make
that possible. The NIH has had the pleasure and burden of making this
happened as expeditiously as possible. That\'s not without its
difficulties and bugs. That\'s partly what we are learning about I
think. What happens with other things that come along, that would
require different kinds of structures or might already belong to
different kinds of places. But that seems to be not the issue before us
here.

Could I ask a question. It\'s probably too early to tell because the
number of proposals is still few. But what are you hearing from the
investigators who want to get up and running, granting that there might
be the usual kinds of impatience between researchers and funding and
assistant sources? But with respect to the procedure, with respect to
the obstacles, what are you hearing from the investigators who say at
last? Are there certain chronic obstacles at the moment? If so, what are
they?

DR. BALDWIN: Well, I\'d say the obstacles are not big obstacles, but
they are certainly issues to deal with. They are really the ones that
I\'ve mentioned. You do have to deal with the intellectual property
issues. I mean, this is something and that\'s true for many products
that are out there in research that you do have to deal with and MOU.
You do have to think about the intellectual property issues.

I haven\'t heard any particular concerns other than the anxiety around
how much emphasis we\'ll place on preliminary data in a field that\'s
going to be a little hard for them to develop preliminary data. When we
know that there are more lines being shipped then we\'re seeing
applications for, it says to me that probably what is happening or what
I am speculating is happening is that some investigators are going
ahead, getting the lines, lines they know will be eligible for our
funding, but working on them some before they apply to us for funding.
That\'s not anything we\'re imposing on anyone.

Most researchers like to put the best application forward that they can
and knowing the difficulty in working with these lines, knowing that
it\'s not simple may want to buffer themselves with some time before
they actually come in with an application that goes into peer review.
That\'s really my speculation from bits and pieces that we\'ve heard.

I think we have six intramural labs that have now received cells. This
is all really very new. I mean, I don\'t know how people\'s cosmic time
sense here is but for me this is very fast for this much of a roll-out
of a very new, exciting, difficult, and high profile area of science.
I\'ve been asked 100 times am I satisfied with the flow of applications,
do I think there should more. You always want to see more good
applications. Always. It\'s not been a flood. But given the
circumstances, I\'m not really all that surprised.

CHAIRMAN KASS: Could I ask a follow-up? To pick up on Dr. Rowley\'s
question before on the question of the characterization of many of these
lines and also on the \-- Well, it really goes to the question of the
purity of these lines as well. Is there anything further that can be
done through NIH, either on that or on the access questions? Are you
being asked by the investigators to lend a hand there? Is there a hand
to be lent?

DR. BALDWIN: Well, we\'re only partway through this implementation. I
mean, we haven\'t stopped the helping hand out there to work with these
sources or to put funding out there for training activities. This is
certainly a high profile issue for us because we know that we\'re doing
things that almost sound contradictory. Somehow, I don\'t think they
are.

One is we want to mainstream the process so the we stay connected to our
fundamental principles and strategies of how we do business and use the
tools. Applications still have to go through peer review. These things
don\'t happen overnight. On the other hand because it is such an
exciting area of science, there really has been a concerted effort. We
have a contact group with all of the institutes involved. We\'re working
very closely with them to use every tool that we do have.

So we\'re trying to balance those two things. I guess our instinct is
that\'s the right strategy, but we have to keep the pressure on and we
have to keep it a high profile issue for the NIH. And we are.

CHAIRMAN KASS: Thank you. Janet and then Frank.

DR. ROWLEY: I\'d like to follow on with two questions. One of which
relates to your earlier answer to me that there are about two dozen cell
lines that have been characterized and again, how you would define
characterization.

DR. BALDWIN: Well, I think part of the problem is I don\'t think there
is that clear of a definition.

DR. ROWLEY: Okay.

DR. BALDWIN: There\'s not tab six that is the clear definition of what
everybody would accept as characterized. That\'s the figure that we\'ve
been using of the ones where there is considerable information about the
characteristics of the lines.

DR. ROWLEY: But it\'s different probably for each one of the six.

DR. BALDWIN: It is a little.

DR. ROWLEY: So that there isn\'t a standard.

DR. BALDWIN: But you\'re now challenging me to go back and see the
extent to which we could line up some of that information and even use
that network that we\'ll create with those sources as a way to drive it
towards certainly some basic understanding. But I don\'t think that
exists right now. I don\'t think we can say here are the six things you
definitely should have done.

I think the field is moving pretty fast. It\'s important for us not to
foreclose anything. I think when you\'re working in a new field one of
the riskiest things for us to do as funders is to inadvertently
foreclose or tighten it down too soon.

DR. ROWLEY: I certainly agree with that. As you say, it\'s as
investigators use the lines they may also through their use find either
additional features or additional problems that hadn\'t been appreciated
before. So all of that is going to be important information. You
indicated you were probably going to get at least some or all of the
sources together to discuss these. What kind of timeframe do you see for
that?

DR. BALDWIN: I really don\'t have a timeframe on that. We\'ve only made
five of the Infrastructure Awards. We still have more to deal with. The
new sources are very new to us. It\'s just too early for me to say.

DR. ROWLEY: So it would be more like a year from now rather than say six
months.

DR. BALDWIN: Probably in between that.

DR. ROWLEY: Okay.

DR. BALDWIN: If you had prompted me, I probably would have said maybe
nine months. But we do not have a specific date on that.

DR. ROWLEY: Okay. I\'d like to change gears if I can but also take
advantage of your long association to senior level at NIH. If you could
help and I think this is related to the question that Rebecca was
asking, we are aware that when Harold Varmus was Director of NIH he had
a working group under Shirley Tillman looking at pluripotent human stem
cells and reviewing some of the procedures to use that. I think when you
said that the focus of the present is narrowed down obviously the focus
of that larger group under Shirley did include some derivation of embryo
research using IVF.

One of the concerns of this group as well as others is how you would see
a somewhat broader group either of the pluripotent stem cell review
group for example that was envisioned in 1998 to 2000 that group was
composed of ethicists and lawyers as well as scientists. At least
that\'s my impression. I believe the membership was appointed by the
Secretary of HHS. I\'m not positive about that, but that was my
impression. Whether such a review group would be an appropriate
regulatory body to actually give responsibility to if for implementing
and reviewing certain aspects or setting certain guidelines for
embryonic stem cell research.

DR. BALDWIN: What kind of guidelines do you have in mind? Do you mean
for areas of science that would be instituted?

DR. ROWLEY: Well, my impression is that the working group under Dr.
Tillman came up with a series of guidelines, some of which you\'ve
already incorporated or were incorporated into the embryonic stem cell
lines that they had to be derived with donor consent and things of that
sort. The guidelines also have prohibited areas of research.

DR. BALDWIN: They\'re still in place. We did not rescind the prohibited
areas of research.

DR. ROWLEY: And our discussions here and the evolution of science in the
last few years has really suggested that some of those prohibitions
might be removed. Then whether a review body of such as a broadly
constituted body would look at the prohibited areas. For example, the
prohibition says no somatic cell nuclear transfer. That\'s now an area
that\'s been supported by the report from the National Academy of
Sciences amongst other things. Is that up to NIH and the Secretary to
remove that prohibition or would there be a broader constituted group
that might look at that?

The other thing that\'s prohibited is actually developing embryos
specifically for research. This is an issue that we\'ve discussed back
and forth. At least some individuals, members of our Council, believe
that it should be allowed under certain circumstances and with certain
guidelines.

DR. BALDWIN: Well, you have certainly outlined a very difficult and
evolving area of science and ethics. The current group, the human
pluripotent stem cell review group is definitely not envisioned as a
group that would be taking on issues such as you described. That is a
group that is really there to address the adequacy of any plans to use
fetal tissue. The prohibitions that were in place in the original
guidelines are still prohibitions that are compatible with
administration policy.

So what we might do in the future is really not something that I could
comment on here. I can say that\'s not the kind of issue that would be
remanded to that advisory group. But we always have the capacity of
putting in place other advisory groups if it\'s warranted. We don\'t
have any specific plans at this time.

Dr. Zahuni (PH) the current NIH Director certainly views this as a very
important area of science and one that requires our due diligence and
careful attention to what our steps should be. So it\'s certainly not
something that\'s going to get any less attention. But I wouldn\'t be
able to comment further than that.

CHAIRMAN KASS: Frank Fukuyama.

PROF. FUKUYAMA: A brief question. Is there any possibility of these
approved lines any of them dying out as a result of mistakes and
handling or inexperience? You said that they are very hard to keep
going.

DR. BALDWIN: That\'s very speculative. I don\'t know. Of all of the
things I worry about in this line \--

PROF. FUKUYAMA: That\'s not it.

DR. BALDWIN: That\'s not on my worry list. Maybe you gave me something
new to worry about.

CHAIRMAN KASS: Robby George.

PROF. GEORGE: Just very quickly. A point of clarification. In reply to
Dr. Rowley\'s last question about who would have authority to lift or
alter the prohibitions that she discussed such as somatic cell nuclear
transfer, can you tell us again who\'s authority would be exercised
there? My understanding is that would require an action by the President
or the Congress, not any advisory body. Am I wrong about that?

DR. BALDWIN: No. You\'re not wrong.

PROF. GEORGE: I\'m right about that.

DR. BALDWIN: Yes. Anytime an issue is up for discussion there\'s
frequently a desire to have an advisory group\'s comment on them.

PROF. GEORGE: Absolutely.

DR. BALDWIN: And we don\'t have a group in place that is doing that.
I\'m not anticipating any changes in that.

PROF. GEORGE: Right. But apart from discussion or advise the policy \--

DR. BALDWIN: That\'s why I said those prohibitions are compatible with
Administration, with our current policy. So I\'m not envisioning any
changes.

PROF. GEORGE: Is that your understanding as well, Dr. Kass?

CHAIRMAN KASS: Yes. That\'s my understanding. This is perhaps a strange
question to put to you. This group as you know has been asked by the
President to monitor stem cell research and to think about offering
guidelines for it. We have spent a fair amount of our time on human
cloning as you probably know. But we have had presentations from Dr.
Gearhart and Dr. Verfaillie. We are trying as best we can to keep up
with what is going on through the NIH.

From the point of view of your activities and what you hear from the
researchers in-house and extramurally, are there things that you would
like brought to this body that might deserve our special attention?
We\'ve been trying to learn really about the implementation policy and
finding out how easily and well are things moving. Apart from the
request that the President should become more liberal and allow more
lines to flourish which I understand would be a perfectly natural
opinion of the scientific community, within the policy as now stated or
in relation to that policy that we would have to consider, are there not
so much advise but questions and concerns that we would be remiss in not
attending to from the point of view of the people that you speak with
and the research that you\'re trying to help develop?

DR. BALDWIN: I don\'t know whether this is a direct answer to your
question. I think what I see most need for right now is scientists just
getting down to work with the lines that are available. There are many
questions that need an informed debate. I think that debate will be
better informed if it can come from not a speculation about what might
happen and whether this is a good enough line or those work are enough
but really more concrete, empirical evidence as to what happens when
researchers get in there and work with these lines.

There are very different views out there as to are they enough, they\'re
not enough, they\'re good enough, they\'re not good enough. But they\'re
a little hypothetical for my taste right now. If they could be better
grounded in experience we may find that people have terrible problems
working with these lines. We may find all kinds of terrible problems. On
the other hand, we may not.

Certainly if you look at the mouse ES experience, it started out with a
lot of lines and it shook out to where there were a few that seemed to
be the most valuable, most useful. Will it be the same way in the human
lines? I don\'t know. We won\'t know unless we get investigators willing
to get in there and in the trenches and starting the work with them.

We\'re trying to put every conceivable mechanism out there to help that
move along, but we still have to get the applications in from the
research community. I guess if you say what\'s the one thing that I most
want to see happen, I think that\'s it because I just think it will just
make the discussions the we could have six months, nine months, ten
months, and 12 months from now so much more empirically grounded. That
would be my issue right now.

CHAIRMAN KASS: Well, thank you. Just a tiny addendum. We are also trying
to plan our own agenda for the remaining 17 or 18 months of our
existence under the existing Executive Order. I know there\'s no real
answer to this question. But order of magnitude. If we wanted to be good
monitors of this and of the research and how it\'s going along, do you
think a year from now there would be stuff to monitor?

I mean, are we going to be able to do what we\'re supposed to do or are
we at the end of this time say let the research go forward, we\'d like
to know what\'s happening? And I\'m not going to hold you to the answer.
But it matters to us I think in thinking about how to plan our own
agenda what kind of time table we ought to be expecting to have some
kind of data coming in. I know it\'s absolutely unpredictable.

DR. BALDWIN: Several things I do know. One is this all takes longer than
anyone thinks it does at the outset.

CHAIRMAN KASS: Right. Rowley\'s Law.

DR. BALDWIN: If you had said anything less than 12 months to tap back in
and see how implementation was going I would say I really think that\'s
too soon. I mean, if you look at a timeline from when these agreements
are in places or when we\'ve actually started to move money to a source
for infrastructure support, we\'re measuring things in matters of weeks
and months here. Science just takes time.

In a year\'s time I think we\'ll certainly have a better sense of the
rate of applications. We\'ll have a better sense of some people\'s early
experiences in working with these lines. But I would not want to over
promise as to how definitive that will be. Less than a year, I wouldn\'t
do it. In a year\'s time, I think it would be a fair question to say
come back in a year or send someone back in a year and say how has it
progressed and how many more investigators, what\'s the experience from
those.

We\'ll have 13 Admin. Supplements. Those are going to be experienced
investigators who are probably our bellwether, our leading edge. In a
year\'s time, I think we\'ll have a much better feel for how difficult
this has been for them or how quickly the sources given infrastructure
support have gotten more common information available about their lines
and whether in fact we have any lines that turn out just to not appear
to work at all. In a year\'s time, I think that would be a reasonable
question to put to us. I would hope I have some answers for you.

CHAIRMAN KASS: Well, thank you. Would you allow me one more?

DR. BALDWIN: Sure.

CHAIRMAN KASS: In connection with your own heavy responsibilities to
this activity, is there someone as part of this project also keeping up
with what is being done in the private sector on this activity to the
extent to which that information is forthcoming? In other words, if one
wanted to say is there somebody at NIH who sits really in command of \--

DR. BALDWIN: Asking the private sector to tell us about what they\'re
doing with their own money and not ours? No.

CHAIRMAN KASS: I don\'t mean that. But there are things that are
published too.

DR. BALDWIN: Yes, certainly. We have been attentive to the meetings that
occur. We have staff at any of the national meetings or regional
meetings, *et cetera* who are staying apprised of where the interesting
work appears to be done. I just have to draw that little line. There\'s
always work that\'s going on in the not federally funded sector that we
don\'t always know about.

CHAIRMAN KASS: Of course.

DR. BALDWIN: There\'s nothing new about that. But no. We are definitely
staying on top of where the developments are to the extent that we can.

CHAIRMAN KASS: Thank you. Alfonso Gomez-Lobo.

PROF. GOMEZ-LOBO: This is an information question. Maybe it\'s out of
your domain. I know that at NIH quite a bit is being done on adult stem
cell research. Right?

DR. BALDWIN: Yes.

PROF. GOMEZ-LOBO: Now, is there any way of comparing volumes? I mean, is
there a lot more being done in adult stem cell research?

DR. BALDWIN: Oh, yes. That\'s a much more established field, yes.

PROF. GOMEZ-LOBO: Okay. Thank you.

CHAIRMAN KASS: Well, it looks like you have answered our questions for
now very forthrightly, very fully, and very helpfully. We\'re very glad.

DR. BALDWIN: I\'m happy to take any other questions that you would like
to probably channel them to me. E-mail them to me and I will try to get
an answer for you if there is anything that I have not gone over. Again,
virtually every piece of information that we have put out there, every
announcement, every piece of guidance, every helpful hint all is
accessible on the website. If you would prefer to receive that as hard
copy, I\'d be happy to pull together a briefing book and send it to you
if the Members would like that.

CHAIRMAN KASS: Well, we thank you very much. Dr. Lee Zwanziger, would
you stand please? Lee is a research director on the staff and the person
most interested in the stem cell aspect of our work. I\'d like at least
you and she to say hello. We can keep a communication open in that
direction.

DR. ROWLEY: I mean, I think that would be very helpful particularly to
the extent that we would have some understanding of the cell lines that
have been reasonably well characterized. For example, are most of them
derived in the U.S.? Are most of them derived elsewhere? Issues like
that would certainly be helpful.

DR. BALDWIN: You sort of challenged me to do an update on that. So it
gives me something to do.

CHAIRMAN KASS: Thank you.

DR. BALDWIN: Thank you.

CHAIRMAN KASS: We are finished a little early. Thank you very much, Dr.
Baldwin. Is Ted Friedman here? If we started a little earlier, people
could finish a little earlier. I don\'t want people who are coming from
out of town just to hear you talk miss the beginning. But we are now ten
after. What if we reconvened at 2:30 p.m.? Then we just finished a
little earlier. Would that be all right? We\'ll take a break until 2:30
p.m. Off the record.

(Whereupon, the foregoing matter went off the record at 2:09 p.m. and
went back on the record at 2:36 p.m.)

CHAIRMAN KASS:  Let\'s come to order. It\'s, if I may so, a special
pleasure and privilege for me to welcome Dr. Friedmann to this meeting
of the President\'s Council. We go back a long way, but we don\'t see
much of each other. And in looking through the bibliography, I just
checked to make sure I was right on the date. I had it right.

We met long ago in relation to what became a paper called [Gene Therapy
for Human Genetic Disease?]{.underline}, [Science]{.underline} 1972,
co-authored with Dick Roblin, who is the Scientific Director of the
Counsel. These are old colleagues and friends. Dick here, and Ted has
been a man of science and a physician who, before it was fashionable is
not the right word. Before it was even conceivable was giving an immense
amount of attention to the large ethical issues related to biomedical
advance.

Ted is Professor of Pediatrics at the University of California - San
Diego Medical School, and also the Whitehill Professor of Biomedical
Ethics at the same medical school. He\'s the Chairman of the Recombinant
DNA Advisory Committee, and a member of the Medicine, Health and
Research Committee of the World Anti-Doping Agency. Also, has been the
Chair of the AAAS Committee on Germ Line Modification, and a member of
the California Commission on Human Cloning. We could use you, and we\'re
very grateful to have you with us this afternoon to take us our next
step in our discussion of questions of enhancement.

We\'ve had a couple of meetings - we\'ve had one meeting on this
before. For some of us, we are even more interested in what these new
powers are to be used for, than where they come from, which is part of
the reason that this is a specially interesting topic. And I\'m looking
for the title of this. I lost my agenda. I don\'t want to get it wrong.
I\'ll leave the title to you. It\'s on the use of - potential use of
genetics for the enhancement of athletic performance, or something close
to that.

DR. FRIEDMANN:  Something like it.

CHAIRMAN KASS:  Very good to have you here.

DR. FRIEDMANN:  Thank you very much, Leon. It\'s really a very great
pleasure to be here. I\'m grateful for the opportunity, and to see so
many familiar faces, it\'s great to have the chance to talk with you.

First of all, I should give a caveat. I do not sit here sort of in an
official capacity as Chairman of the RAC. I may let some RAC kinds of
things slip by, but please don\'t take that as policy from the RAC. What
you\'ll hear is my own opinion.

Much of what I\'d like to cover briefly has already been presented to
you in your background paper, Number 7, I guess, that you\'ve had a
chance to look at over the past - and I will reiterate some of the
points there, and make a few additional points. And then at the end, I
hope leave you with some questions that I think may be germane to the
function of this Council.

I should allow apologize in advance for some of the Power Point
features. This is the first Power Point presentation that I\'ve
prepared, and you\'ll see titles flying in, up and down, and I apologize
for that. If any of you get motion sick, it\'s not my fault.

All right. So let me start by posing three questions that I\'ll come
back to toward the end of my presentation, and that has to do with these
questions. Is genetic enhancement feasible, and is it likely, and is it
desirable under some conditions? Two, what have we learned from the
world of gene therapy that may instruct us about the potential for
genetic enhancement? And three, does sport and athletics represent a
kind of scenario which might be a useful springboard for discussing the
opportunities for genetic enhancement. Is it, in fact, feasible in
sport? Is it likely, and under some conditions is it maybe even
considered desirable? So I come to these issues from three backgrounds,
and I\'ll try to be a little bit personal about some of this if it\'s
all right with the Council.

These come from three interests that I\'ve had for a very long time.
One, obviously in genetics and gene therapy, which is my day job.
Biomedical ethics, which is kind of my afternoon and early evening job,
and then a background in sport, which I don\'t have personally, but
which comes to me through my family. So this is my family connection.
These are medals that my father won as an athlete in sort of Central
European athletics pre-war. And it was in the context of this kind of
view of sport and all its beauty, and all of its sort of effort that I
grew up thinking that sport was a beautiful and lovely endeavor, and one
that ought to be protected.

The other part of the background that I bring to these issues is an
experience that comes from my early sort of post-doctoral time. After a
stint at the NIH, I went to the Salk Institute, ostensibly for a year to
learn something about viruses and virus vectors, and came under the
influence of Jacob Bronowski, who was there at the time as the head of
the Council for Biology and Human Affairs. And the Council was
interested in directions that science was going, the directions that
genetics, molecular biology was going at the time.

You\'ll recognize from the years that that was before the era of
Recombinant DNA technology, but the people at the Salk were wise enough
to know that it was coming, and Jacob Bronowski asked me and one of my
colleagues to look into the issue of where molecular biology was likely
to take medicine in the near future. And that was based on the
presumption, on the intuition that the approach to genetic disease at
the time was flawed.

Now I won\'t be able to point at anything, but this is kind of a scheme
of genetic disease, and the - well, it does point. Okay. A scheme of
genetic disease and directions from which one might approach treatment
and understanding of genetic disease. And you can see here, so there is
the DNA with the X indicating a mutation response for disease. That
gene, that mutant gene is responsible for making this gene product, and
that gene product has the role of driving a metabolic step here. If that
metabolic step is defective, then one induces a state of disease by
either producing too little of a gene, of a metabolic product, or
accumulation here of Product B. And it suggests a number of ways in
which disease can be understood and treated. And you\'ll recognize that
this is the scheme - for those of you who are interested in medical
history and the history of science - this is the scheme that comes
directly to us from Sir Archibald Garrett at the beginning of the 20^th^
Century and his rediscovery of Mendel\'s Principles in 1900.

You\'ll notice that, and I think if you think about this scheme, and you
think about what it implies about therapy, you\'ll recognize that
everything that happened essentially during most of the 20^th^ Century
in terms of therapy, is aimed at sites of this pathogenesis scheme
everywhere except where the defect is. The defect is here in the gene at
X, here in the DNA, and all therapies have been aimed, from time zero
have been aimed everywhere other than for the site of the defect. And it
became clear in the late 60s or so from work from many places, that the
opportunity was going to arise in the reasonably near future to begin an
attack on the mutant gene itself as an approach to treatment, so that
takes the form of this cartoon.

The cartoon says, \"You fix what\'s broken.\" On the left side is a
broken dam, representing a mutuant gene. That results in a metabolic
flood downstream and a mess, and all therapy until sort of the end of
the 20^th^ Century took the form of cleaning up the mess, and it began
to be apparent to a number of people, sort of in the mid-60s, early 70s,
that the opportunity would come to fix the dam, to fix the gene.

So here is the paper that Leon kindly referred to, and you\'ll recognize
two things about it, three things about it. One, the date, 1972. Two,
that one of the authors of this is Richard Roblin, who\'s your Science
Director, I guess his title is. And three, there\'s a question mark at
the end of the title, which meant that we really didn\'t know what we
were saying, but we thought it was all going to come true, and so we
published this in size at the behest of the Council for Biology in Human
Affairs, and Jacob Bronowski\'s invitation to prepare this initially as
a white paper for the council.

And what Dick Roblin and I sort of envisioned at the time was not only
is this an option for treatment of genetic disease, but it really is a
requirement finally for designing rational therapy of human genetic
disease. It was a necessary new step, a necessary next step in the
treatment of disease.

We envisioned that the approach would be to introduce functional
therapeutic genes into cells to correct genetic defects, to correct
mutations. And then we envisioned the use of viruses to do this. We did
that because we were working, both of us, in a laboratory of virology
with Renato Dulbecco, who had just established the mechanisms by which
viruses cause cells to become cancer cells. And we thought well, if a
virus can cause a cancer by introducing its own gene into cells, maybe
we could fool the virus, use it as a trojan horse to carry therapeutic
genes into defective cells, so we liked the idea of viruses. They were
efficient and they did the right thing.

We thought that in order to move ahead with such a procedure, one needed
a very profound understanding of pathogenesis. We were worried a little
bit that this field would lend itself to premature use, and to the use
of immature technology in the name of therapy. And were concerned about
when and if this would really move to human clinical application.

We saw a number of ethical and policy dilemmas, including the potential
for germ line modification, and the use of gene transferring to modify
traits that were not obvious to everybody, obvious disease traits, but
rather traits that were other sorts of human capability. That, of
course, is the subject for today. And we thought that all this was so
important, and so likely to be a difficult area of the confluence of
technology and policy, that there was going to be a very - a need for
heavy local and federal review and regulation of the technology,
including FDA and local hospital committees.

The paper appeared at a time, first of all, before recombinant DNA was
available, and also before any vectors were available to move genes
around, but those virus vectors became available over the next decade or
so. And the details of this aren\'t important, but simply indicate two
approaches to introducing genes into humans.

Here is a patient with a human genetic disease, a woman at six o\'clock.
She might be treated genetically in one of two ways. She might donate
some cells to a tissue culture plate, which would then receive a virus,
or some other gene transfer vector in vitro. Those cells would then be
genetically modified and returned to her to compliment some genetic
defect that she had. That\'s call the ex vivo approach to gene therapy.
In contrast to that, of course, is the in vivo approach, and with this
virus vector here on the left side of the picture, is introduced
directly into the patient to correct the defect, so that\'s the in vivo
approach.

I hope this doesn\'t make you dizzy. This now - the elaboration of this
concept really came first in a most clear fashion from LeRoy Walters
some time later, who developed this matrix for understanding gene
therapy, and it took the form shown here. So the initial approach was
obviously to use somatic cell modification to correct a disease
phenotype, so for real therapy of a disease trait.

LeRoy was concerned also about eventual use of a germ cell as the target
for genetic modification, and envisioned that that could also be used
for therapy, for prevention of disease or for therapy, but he also
assumed sooner or later that somatic cells would be targets for the
introduction of genes designed to enhance traits, rather than correct
disease phenotypes. And the same thing to be done at the level of germ
cells, so he had this four-way matrix, somatic cell, germ cell, therapy,
enhancement, as four areas in which gene transfer was likely to become
feasible in the human being.

In terms of disease targets, very early the initial disease targets
tended to be in-born errors of metabolism, single gene defects because
they had a single gene missing, rather easy genetics to try to sort out.
And in principle, all one had to do was to put the gene into the right
cell at the right time, and you\'ve got a cure.

Not too long after that, of course, it became clear to many people that
other kinds of diseases ought to represent targets for genetic
modification. Complex diseases in which many genes talk to each other.
Cancer is a gene in which many genes are - a disease in which many
genes are involved. Neurological disease, psychiatric disease,
cardiovascular, all those things became very popular targets for gene
transfer kinds of studies. Even infectious disease, so non-in-born
errors, non-genetic diseases, but diseases which had available genetic
targets that one could manipulate to modify the disease process.

And I won\'t go through the history of the 80s, late 70s, 80s, and early
90s, only to show you that all these concepts grew very rapidly at the
beginning of 1990s, the last year or so of the 80s, \`89/90, and the
concept was that all you need is a gene, a target cell, and that therapy
would be rather straightforward and rather easy.

In 1989 was the first clinical study, human gene transfer study. 1991
was the first potentially therapeutic study, and you can see what
happened over the next some years. Many proof of principle studies have
been done in animal systems. Those animal systems look very promising,
and by 1990, I can\'t see the date, \`98/99, there was an enormous
amount of optimism - well, by 1995 there was an enormous amount of
optimism that this job would be really quite easy.

In \`95, you can see a little dip there from 44 to 28. In 1995, a series
of papers appeared which showed for the first time that the job was
going to be more difficult than we thought. There were a number of
rigorous studies which, for the first time, showed failure, rather than
this sort of exaggerated over, hyper-expectant field that had come to
develop, which we thought things were going to move very quickly. In
\`95, things obviously became much more difficult. And the field of gene
therapy kind of began to be more introspective, and to emphasize more
rigorous hard basic science. But that also began to grow, and by 1991
- sorry, by 1998/99 things were growing again.

And then, of course, in 1991 came the disaster in Philadelphia with
Jessie Gelsinger\'s death, and another pall was cast on the field,
indicating again that there were many surprises, and many unexpected
reversals that we should be on the look-out for. That field was, in
fact, going to be far more difficult than we had anticipated, and that
it was filled with traps, and with potential pitfalls that only careful
clinical experimentation would eventually clear up for us.

However, what\'s happened since 1999, and since Jessie Gelsinger, is
rather impressive. You can see now by March of this year, there are more
than 500 clinical studies being carried out in many countries in the
world, most of them in the U.S., but many studies in Europe, and Sweden,
and Japan, China and others. Most of those studies are for cancer for a
number of reasons. A number of diseases are, in fact, common genetically
complex diseases, cardiovascular, neurodegenerative disease, arthritis.

The first clinical success after 30 years after the Roblin-Friedmann
paper, finally after all that promise and all that expectation, came
what looks to be a real success over the past two years, a study in
France carried out by Dr. Alain Fischer in Paris, showing, I think quite
convincingly, and only time will tell if it\'s a cure or not, but quite
convincingly, a phenotypic cure of children with an immunodeficiency
disease, X-linked SCID. That\'s now been repeated in another form of
immunodeficiency, and it looks as if we\'ve turned the corner now. The
field exists, it\'s a reality, it\'s a clinical reality, and poised to
move into other clinical situations.

At the same time, there\'s been no overt enhancement studies reviewed or
approved by the local or federal regulatory review process. So again,
June of this year, very impressive apparent success by Alain Fischer in
Paris. The ADA SCID model, which is a similar disease, seems now to have
been cured. The paper last week in [Science]{.underline} indicates a
very similar approach, with similar results.

Interesting, and probably real results are being obtained now with
coronary artery disease with injections of agents designed to induce new
blood vessel formation in the heart, and also in peripheral tissues.
There is a continuing slowly advancing number of studies in cancer
showing some response of some cancers in some patients, and a very
promising approach now with Factor IX Hemophilia, which seems to be
poised on the edge of showing some clinical efficacy.

So what do we conclude from all that? That the field is real. That it\'s
beginning to show clinical effect. However, we know better than ever
that the field is faced with many unknown, and many known dangers and
problems. We learned that in spades from the Philadelphia study. The
gene therapy studies have to be considered clinical research in the
strictest form of that word, and therefore, require all the local and
national regulatory review processes that clinical research needs. That
the wish to do good, of course, is not on its own enough, to undertake
studies, and that the studies have to be designed properly, a result
that also came from the disasters in Philadelphia and a number of other
places in which clinical design was possibly not as rigorous as it ought
to have been. And that any applications of gene transferring outside of
this realm of review and regulation recognizing the hazards and
difficulties, and problems would be inappropriate, hazardous to the
patients and to the participants in the study, and therefore, probably
unethical for reasons, at least, based on safety.

All right. So we get to the point we\'re back to LeRoy Walters\' matrix.
Therapy of somatic cells, treatment of somatic cells with foreign genes
for the purpose of therapy seems now to be a reality, and that takes us
then in the next step to the potential for using exactly the same
methods to modify traits that are not disease traits, but at least
farther out on this disease/non-disease spectrum, and begin thinking
about enhancement.

That doesn\'t come as a surprise to us because we already accept and
seek enhancement in our society in many ways. And that was, of course,
also reviewed very well in your document number 7, and I won\'t repeat
all of that. Just simply to say that cosmetic surgery is with us, and we
accept it, we seek it out. Recreational drug use is with us, and we
accept it and seek it out. Psychopharmacology, an exploding area, a very
important area which obviously comes initially from the need to treat
psychiatric disease, but also to treat the rest of our neuroses and
behavioral deviations. And, of course, the use of anti-depressants,
tranquilizers and serotonin reuptake inhibitors, things of that sort,
are ubiquitous and universal in our society, and we hardly question
their use any longer.

Attention deficit, hyperactivity disorder, a very popular and very
important potential area. I don\'t know what the figure is now, but it
must be 30 percent of children in this country on Ritalin, requiring 50
percent of the teachers to go on Prozac, I guess. But it\'s a situation
that we accept, and we know, and we don\'t question it very much at a
societal level. The area of aging offers major new areas of socially
acceptable enhancement. Again, that was covered in your document number
7.

There was a very interesting review in the [New York Times]{.underline}
last week on the use of anti-depressants to sort of underscore what
I\'ve just said, and indicating that social phobias and generalized
anxiety, premenstrual distress and many other behavioral issues are
targets, and probably legitimate targets for drug therapy. And in that
article, a quotation as given below, \"Psychiatrists argue that such
conditions are real illnesses, but others say the impression is often
conveyed by commercials.\"

It\'s clear, almost everybody could benefit from them. Symptomatology is
so broad and vague that any one of us could say yeah, that\'s for me.
And we all know that. We watch the commercials and we think maybe that
would help me.

Well, if we accept enhancement, how far are we from accepting - if we
accept pharmacology-based enhancement, how far are we from accepting
genetically-based enhancement? The pressures for that come from,
obviously, from the general acceptance of enhancement, in general from
drugs. The indistinct line between disease and non-disease, what is one
person\'s Alzheimer-based memory deficit is another person\'s desire for
a slightly sharper memory, to memorize a role that he needs to enact on
a stage, or learn a piece of music, or something of that sort.

The Genome Project, and other advances in genetics, is dumping into our
lap all kinds of genes involved in personality and cognition traits. You
all remember probably the early days of the century, again the work of
Archibald Garrett at the Cold Spring Harbor Genetics Record Office, in
which everything was considered to be genetically determined, including
love of the sea, thalassophilia, slovenliness and things of that sort.
Those kinds of traits were based - were presumed on the basis of poor
science to be genetic, at least partly genetic in origin, but those days
of genetics are no longer with us. But we\'re now, of course, coming to
realize that genes do play an important role in personality and
cognition. And those genes are coming to be identified slowly but
surely. And will, therefore, eventually be targets for manipulation.
And, of course, the increasing pace of clinical efficacy in gene therapy
is providing tools which are likely to be useful in an enhancement
setting.

All right. So if that\'s true, then on might begin to wonder about what
kinds of approaches in the therapeutic sense may open doors
inadvertently to enhancement. And I would like to just remind you of a
number of studies, protocols that have been reviewed by the federal
regulatory agencies, by the RAC, which are therapeutic in intent, but
which have implications for non-therapeutic use for enhancement kind of
applications. So these are a series of studies that have been proposed
to the RAC for therapy.

The first one here is the use of IGF-1, insulin-like growth factor for
treating a muscle wasting disease in a peripheral nerve entrapment
syndrome. It\'s called the Cubital Tunnel Syndrome in which a nerve gets
entrapped, leads to muscle wasting. The proposal reviewed by RAC was
that a non-viral vector of plasmid would be injected into the muscle
around this blockage to stimulate nerve regeneration, muscle
re-innervation. That would be directly injected in the muscle. And
because the vector in this case is not a virus, but rather just a piece
of DNA, its affect would be transient, but it would stimulate local
muscle repair and maybe nerve regeneration, as well. Clearly, this is
therapeutic in intent, but again clearly, the injection of IGF-1 into
muscle has other implications. We\'ll get to that in a moment.

Another study proposed to RAC in 2000 had to do with the production of
Erythropoietin, to increase hematocrit levels in patients with chronic
renal disease. These patients have difficulty with maintaining adequate
blood production, and one way to treat that, other than for injections
of Erythropoietin, is to introduce the Erythropoietin gene into the
smooth muscle cells of these patients in vitro in the laboratory, and
then use those genetically modified cells that are now producing EPO to
line an artery-vein dialysis graft that these patients have implanted.
Those cells would sit down on the graft, and produce a constant supply
of EPO, which would then increase the blood production in these
patients.

Still another study reviewed earlier this year by the RAC, a very
important study, suggested the use of growth hormone as an approach to
treating Cachexia in cancer patients, have this terrible wasting
syndrome very often, and one doesn\'t know what that\'s due to, but one
potential approach to treating it is to introduce growth hormone, or
things that will produce growth hormone into those patients. And this
study, in fact, proposes exactly to do that, to use a hormone called
\"Growth Hormone Releasing Hormone\" to stimulate the pituitary of a
patient with cancer to produce its own growth hormone. That would then
- to increase body weight, and to prevent parts of this Cachexia
Syndrome from developing. The amount of growth hormone could be
regulated in this system by the administration or removal of an oral
drug, in this case, RU-486, which has the property of turning on or off
the gene in this case.

Again, it\'s not a therapy for cancer, but it\'s the therapy for
something that comes with the cancer, and that\'s the Cachexia. This has
the implications, of course, of developing methods for introducing
something that will turn on or off growth hormone in a conditional sort
of way, and has applications that we can get to in a moment, as well.

You can\'t see that very well. Two weeks ago at the RAC meeting, we
reviewed still another proposal, which is therapeutic in intent, but
which also begins to sound potentially enhancement-related. This is a
proposal from Dr. Melman in New York, to treat erectile dysfunction, not
with drugs but rather with genes, introduced directly into the corpus
cavernosum. This is a potassium channel gene that has the property of
modifying blood flow in and out, and therefore - and that gene becomes
active only during sexual stimulation. And therefore, in animal studies,
has shown to produce reasonable results. And like Viagra, of course, has
the potential for treating a real problem in some men, but also to go
the direction of some Viagra use, and that is an enhancement sort of
use.

Well, okay. So if we accept enhancement, is sport an area in which
enhancement is likely to find a home? You won\'t recognize this person
here, but that man is Arne Ljungqvist, who is the Chairman of the - who
was President of the Swedish Cancer Society, but in this era, he was
Olympic high-jumper for Sweden in the 1952 Olympics. And he\'s the
Chairman of the World Anti-Doping Agency Committee on Health Science and
Research.

So the question is what, of course, determines performance in sport. At
least three things do. One, talent and drive. Those tend to be not
terribly manipulable, but are innate and learned, and partially
genetically determined. Of course, there\'s training, manipulable kinds
of training, what equipment you use, what opportunities you have to
train. And, of course, then physiological manipulation,
performance-enhancing drugs, environmental changes. You train at
altitude if you\'re going to be an endurance athlete. And now the
question of new genetic functions becomes pertinent.

It won\'t surprise you to learn that doping is extremely common sport,
in some sports more than others. I won\'t reiterate all that, just
simply again to remind you that it happens, and the sport profession
considers it a problem. Some people do, at least. There was a question
in the [L.A. Times]{.underline} several days ago by Jerome Holtzman, who
is the major league baseball historian, and his attitude was I don\'t
care if guys are taking steroids or not. If they\'re taking these drugs,
and if they want to risk their bodies so they can hit 20 homers a year,
that\'s their decision, so that\'s kind of the official statement from
baseball.

You all know from the tests that U.S. screening agencies have had sort
of a love/hate relationship with screening, and in screening for Olympic
athletes, the U.S. committees have not always been as effective as they
would like to be.

You all know, of course, the response of the U.S. population to Mark
McGwire\'s homerun hitting feat some years ago. That was not met with
universal disdain or disapproval. It was really quite welcomed by most
sports fans in the country. And, of course, the recent revelation of
baseball use of ‑ probably much more ubiquitous baseball use of
steroids and the response that that\'s had. So sports organizations look
down officially on the use of these kinds of agents. There\'s a list of
banned substances. That list is evolving all the time, but tends - but
includes things like Erythropoietin as drugs, not as genes, as drugs,
growth hormones to improve strength, anabolic steroids, stimulants and
narcotics are banned. Diuretics and plasma expanders are used commonly
to hide the use of other drugs by athletes, and those are also banned.
Beta blocks are banned.

Medical exceptions are permitted under some conditions by the sports
authorities. And recently, a revision of some of these lists of banned
substances has begun to exclude things like caffeine and marijuana,
which are universally used. Alcohol, which are universally used, but
which have not been shown to be sports enhancing, and therefore, they no
longer sit on lists of enhancing drugs.

The sports world tests for drugs and screening in a number of ways. The
International Olympic Committee and other international bodies have had
screening methods in place for some time. National Athletic Associations
similarly.

In 1991, the IOC and the member nations established the World
Anti-Doping Agency, the World Anti-Doping Association, funded by IOC,
which has a three-part program to screen both in and out of competition,
to educate athletes, and to do research on detection and screening. And
then the member nations have their own versions of the same kind of
agency, in this case, the U.S. Anti-Doping Agency.

So why does one think that genetic approaches to athletic enhancement
are inevitable? First of all, athletes are risk-takers. They\'re young
healthy athletes who think nothing is ever going to happen to them. And
they are known to accept all sorts of risks. Polls have been taken of
young athletes asking if I were to guarantee you a gold medal in the
next Olympics at the risk of losing 20 years of your life would you do
it? And universally, they say yes. They will take that risk for the
reward of gold medals.

There are enormous financial pressures and national pressures to push
athletes to perform and to win. We know that they use pharmacological
approaches to enhancement. WE know that they\'re aware of gene transfer
technology, and we know that that technology is still immature, but
it\'s advancing rapidly. And we know that many of the studies in gene
transfer technology, in fact, use the genes that are of particular
interest to athletes, Erythropoietin, growth hormones and other relevant
genes.

There\'s a general perception among the athletic communities that these
manipulations genetically would be less detectable than pharmacological
intervention. That\'s not at all clear, but that\'s what the athletes
seem to think. So how does one enhance athletic performance genetically?
One can increase oxygen carrying capacity with Erythropoietin. One might
enhance skeletal and cardiac muscle function growth hormone, IGF-1, and
other forms of growth hormone. One might imagine increasing blood flow
to a particularly stressed muscle with agents designed, as in the
cardiovascular therapeutic setting, to increase blood vessel production
to that organ. One might imagine altering energy utilization by the
tissue to raise pain threshold of injury, and to prevent injury, or to
accelerate healing by genetic means.

So let me give you now several examples of the way in which preclinical,
therapeutic preclinical studies have used relevant genes to convince
people that use in athletes is possible, and probably inevitable.

The gene in this case is Erythropoietin, and it\'s been transferred into
Baboons with this vascular graft approach that I described before. In
this case, cells from the Baboon are injected with a virus that
expresses Erythropoietin. Those cells then are used to line this
vascular graft. And here you see the affect on the blood production of
the Baboon over more than a year. The top closed circle curves represent
the levels of red blood cells in this Baboon after a single injection, a
single introduction of the smooth muscle cells into the graft. The lower
curves represent the control animals, and you can see that the
manipulated animals develop hematocrit levels, red blood cell levels
well over normal, and up to the 70 percent level. That can be good, or
it can be bad. And obviously, it\'s very dangerous if it goes too high
because that predisposes to strokes, and to other cardiovascular
disasters.

Here\'s the use of another cell line to introduce Erythropoietin into
animals, again the same affect. In this case, carried out over a shorter
period of time. But again, you can see a prolonged elevation of
Erythropoietin using a muscle cell to deliver the gene. Here\'s a
different virus, an adenovirus vector. Adenovirus is used commonly in
gene therapy studies, and on the right panel you can see a very
prolonged elevation of hematocrit levels in, I guess in what animal?
This is Baboons, as well. Prolonged increase of hematocrit levels after
a single injection of a virus into the muscle of these animals.

Here again is the single injection of a different virus into non-human
primates. The lower right curves show you the persistence of increased
hematocrit levels in these animals, despite the fact that the serum
Erythropoietin levels in the very far lower right curve drops after a
while, the hematocrit level stays up for more than a year.

So a single injection of a vector carrying the Erythropoietin gene
works. It increases hematocrit levels. And in some other of these, this
can be turned up and down at-will, so you can take this animal and treat
it with a small drug orally that will turn off this affect. The
hematocrit level comes back down to normal. You can then turn it back on
at-will, and you can bounce back and forth many, many times to modify
and to titrate the amount of red blood cells that you want.

With respect to muscle, very impressive studies by a number of workers,
Sweeney in Philadelphia, and Goldspink in London have taken IGF-1, this
insulin-like growth factor, and similar muscle growth factors, injected
them into mice. Those mice then develop much bigger muscles, stronger
muscles. If you tie little weights to their tails and force them to
climb up a little pole, the injected - the mice with injected muscles
climb higher, and faster, and carry more weight than the controlled
mice, so it works. The muscles get stronger, they get bigger, and they
also show improved muscle repair properties.

I\'ll just skip that. That\'s more of the same. One might even, in fact,
look upon this as a preventive procedure. Here is a study by people
interested in preventing or treating joint injury, again with IGF-1,
with insulin-like growth factor. In this case, cells from a joint were
treated with a virus carrying IGF-1, and then put back into the joint.
And on the left, you can see the thickness of the synovial membrane, the
membrane in the joint that protects the joint from injury on the left,
and on the right. The same cells now treated with a virus producing
IGF-1, you can see the thickness of this synovial system, synovial
tissue is much greater, and this joint is less likely to be injured, and
is more likely to recover more quickly.

So is application of these experimental kinds of approaches feasible in
sport? To remind us all again, some of the properties, the lessons that
we learned from gene therapy, so gene therapy is feasible in humans. It
can be therapeutic. It can correct and treat disease. All present
approaches to gene transfer must be considered experimental. The current
methods are still immature, and many unknown dangers, and known dangers.
Methods for gene transfer into humans all must, at the moment, go
through this process of local and federal review. And I would suggest
that rogue use, or illicit use in athletics or any other area, which
circumvents that process, that is, the gene transfer into humans for
other purposes, whether it\'s therapeutic or whether it\'s enhancement,
which circumvents the review and regulatory process is dangerous to the
subject, as unacceptable. And, therefore, I would posit, is unethical.

Well, you can say that, but that may or may not convince athletes, and
enormous pressures exist in athletics which make this kind of direction
very likely, and inevitable. And the reasons are the following, the
athletes, and their handlers, and federations know about gene therapy.
They know vaguely what\'s happening, and they know that the field now
thinks that it\'s turned this corner of efficacy. What they don\'t know,
and what they don\'t appreciate is the safety concerns and the dangers
lurking behind every corner.

If this application to athletics is to be done, it probably will be done
in a private setting, and private setting studies do not require review
by the RAC. They do need to go through FDA, but certainly don\'t require
RAC review. And that private and governmental funds are available to
accumulate the kind of molecular expertise that would be required to
make these vectors, to solve the rather trivial problems of delivery to
the appropriate tissue, and simply to take the published data from gene
therapy world and apply it in an enhancement setting in athletics.

Regulatory structures largely are silent on the issue of enhancement,
and that might be, in fact, a question that this Council might like to
pose. Is continued silence on the issue of enhancement a wise thing to
tolerate?

We come back to the caveat that Dick Roblin and I sensed in our initial
paper; and that is, the likelihood that immature science is going to be
used before it\'s ready for real application. It happened in gene
therapy. It\'s likely to happen in athletics. So faced with that issue,
a number of agencies have tried to provide a shot across the bow of
those who might want to circumvent these concerns. In 2000, a couple of
years ago, the World Anti-Doping Agency incorporated into its Medicine,
Health and Research Committee an effort to identify the potential for
gene therapy as an approach to - for gene transfer as an approach to
doping.

Last year, the International Olympic Committee, taking that cue from
WADA, had a one-day meeting in Lizon (phonetic), which began to identify
the potential dangers to sport, and this year, several months ago, that
the World Anti-Doping Agency sponsored a meeting at Cold Spring Harbor,
a three-day meeting which was designed really to look in some detail
into the potential for genetic modification in athletics.

That meeting urged a number of things. It urged the publication of the
proceedings for general promulgation to the scientific and sports
community. It also called for dialog in the public sector, position
statements from professional societies such as the American Society of
Gene Therapy, to look at the issue and examine whether this is a real
concern and what, in fact, one might do to head it off.

Also, this spring the American Society of Gene Therapy held a symposium
at its annual meeting on potential applications of gene transfer in
sport, and next year AAAS is going to have a similar symposium.

So back to the original questions that I posed, and I am going to wind
up now, back to the original questions: Do advances in human gene
therapy affect the potential for genetic enhancement? I think the answer
to that is a clear yes.

Is genetic enhancement feasible, likely, and desirable? I think it is
certainly feasible and likely. Questions of its being defensible and
desirable is something that deserves your careful consideration.

Finally, is the enhancement of athletic performance feasible, likely,
and desirable? I think it is certainly feasible. Attempts will be made
soon, and its desirability again is not clear.

So let me leave you, then, finally, with some questions that might be
interesting for your Council to consider. These questions are difficult,
and we certainly have not been able to answer them even in the context
of the World Anti-Doping Agency.

So one question is, of course, what is sport and what is it that we are
trying to protect in identifying genetic approaches to modification?
There is a classical view of sport I call the romantic view of sport,
the kind that I grew up with at home, that says it is the effort and the
triumph over adversity that makes sports so beautiful. We know that
sport is more than that. Sport is entertainment. Now it is an economic
force. Therefore, it is a different beast from what it was some years
ago.

As an undergraduate I studied a little bit and took a course with a man
named Paul Schrecker at Penn, who had developed a principle of work and
history looking at the features that make a society. He identified six
major areas that define societies: development of the state, science,
religion, the aesthetic province, economy, and language. He did not
include sport. Sport, to whatever extent he discussed it, was included
the aesthetic province. But it may be that sport represents something
more aboriginal than that and very basic human instinct, and may, in
fact, represent a completely different province of society.

Sport is a technology which is manipulable in terms of material science.
We make better swimsuits. We make better skis, more flexible pole jump
poles. But it also represents now an area of biotechnology and
bioengineering. It is not quite as clear to me and the WADA Committee
whether that is a good thing or a bad thing. You might want to ponder
that.

Does sport offer a useful arena for ‑‑ I guess I shouldn\'t have used
the word \"arena\" there ‑‑ does sport offer a useful area in which to
examine this intersection of technology, in this case genetic
technology, with public policy? Where do they clash? Finally, if we
accept, as a society accept, enhancement in general, what is it that
makes sport different, if anything, and why?

On no particular subject, I just wanted to make one plea to your Council
based on things that I heard this morning. There\'s no question that
this march of technology, both in therapy and in enhancement, is going
to continue and accelerate. You need and we need an enlightened public
policy, an enlightened discourse.

It seems to me a terrible thing that the U.S. has relied on very few
stable bodies to continue a discussion of technology and public policy.
The OTA was one such body, but we don\'t have that any longer. All the
previous bioethics councils have come and gone. They have been too
transient to keep up institutional memory and a momentum.

I would certainly hope that this body, in whatever way it can, can make
the point that it is an ethical issue, a bioethical issue, to have a
national body to continue to advise our policymakers on what is coming
next and how to prepare for it.

So let me stop there and thank you very much for your attention. I would
be more than happy to try to expand on any of this, if you would like.

CHAIRMAN KASS: Thank you very much.

Could we have some lights and this machine turned off?

I think the presentation makes very clear how developments intended for
therapeutic purpose can acquire a life of their own and are used for
things that are beyond therapy, not necessarily making them either
undesirable or wrong, as really beautifully documented here. Other
people may want to weigh in with different questions.

Granted that you and colleagues have concerns for the area of genetics,
and therefore the uses of genetic technology. The question of a genetic
means of delivering performance enhancement would be an obvious new
question for you. But I guess, could you help on this question: Why in a
world of steroids and epo available by injection and orally ‑‑ what if
someone said, look, this is really rather precious and very highly
sophisticated, but how is this different, or is it different, and why is
this likely to be a much larger problem than the one that is now faced,
if it is a problem?

What about the genetic angle makes this special? That is the less
interesting question, I guess, as to what we should think about this,
and if we should think ill of it, how to proceed. But just on the
narrow, technical question, why is the fact that this is
genetically-delivered enhancement special?

DR. FRIEDMANN: I am not sure that it raises any new issues. It raises
issues ‑‑ the interest in this area seems to come from the general
perception in the athletic community that this can be done more
surreptitiously, and, therefore, less likely to be detectable, if in
fact you can do it with a one-shot administration of something, turn it
on and off at will ‑‑

CHAIRMAN KASS: With small molecules?

DR. FRIEDMANN: And, therefore, not so easily subject to
out-of-competition testing. I think that is a misperception because what
is detectable, of course, is the physiological effect of the introduced
gene, and that is going to be presumably as detectable as if you had
injected yourself with the protein itself, rather than the gene.

So I don\'t think that there is a new kind of ethical issue that
separates genetic doping from pharmacological doping. It is a challenge
more, I think, to the athletic community because they are going to have
to devise different kinds of methods of screening and detection. It is
also a challenge, I think, to the gene therapy community because the
applications in athletics, when they come, if and when they come, will
come outside of the realm of current standard review and regulation. It
seems to me that that is clear.

How, in fact, to be on the alert for that and how, in fact, along the
lines of this shot across the bow, how do we warn people, athletes,
first and foremost, because they are the ones who are in most danger of
being injured by such a manipulation, which is, after all, maybe less
easy, less redeemable, and less easy to reverse than simply stopping
taking a drug.

The genetic manipulation is probably going to be less forgiving, maybe
less manipulable and less titratable, but also less easy, more difficult
to reverse. That increases the danger to athletes. That danger is not
being advertised by the sort of between-the-lines support that one is
beginning to see in these rogue athletic communities for this approach.

So I think the fairest answer is there\'s nothing ethically new here,
except from the gene therapy point of view, and the insistence that, if
and when these kinds of manipulations are done, they must be done in the
context of clinical research and not in the context of sort of East
German approach to swimming as of some years ago.

We need to be sure that the athletes are aware of that and know that, if
they are being attracted by promises of surreptitious and less
detectable approaches to doping, that they need a high level of
suspicion. So the work of the Vardon, and you saw at the moment, is in
fact to provide that shot across the bow.

CHAIRMAN KASS: Robby?

PROF. GEORGE: Thank you, Dr. Friedmann, for that wonderful presentation.
I wanted to ask a couple of questions by way of clarification, and then
I have a more substantive question.

On clarification, one of your slides identified a list of stimulants
that have become socially acceptable, and they included caffeine and
marijuana and LSD.

DR. FRIEDMANN: I don\'t think I had LSD on there. I hope I didn\'t.

PROF. GEORGE: Okay, I\'m sorry.

CHAIRMAN KASS: No, he didn\'t have that, either; just caffeine and
marijuana, unless you were taking something.

(Laughter.)

PROF. GEORGE: By socially acceptable, you simply, I take it, mean that
it is widespread in its use?

DR. FRIEDMANN: Widespread, and those agents have been on the list of
proscribed drugs in the past, but a recent list developed by WADA now
has removed them because they have not been shown to be
performance-enhancing. They are lifestyle kinds of drugs, lifestyle
agents, that are common, but which the athletic community no longer
sees, or may no longer see itself in the need to proscribe because they
are not performance-enhancing.

PROF. GEORGE: Okay. I was wondering if socially acceptable there refers
to accepted in the broader ‑‑

DR. FRIEDMANN: In the broader sense, sure.

PROF. GEORGE: In the broader society?

DR. FRIEDMANN: Wider used; therefore, a lot of people accept it.

PROF. GEORGE: But while it would seem to me caffeine is socially
acceptable, cocaine and even marijuana is in a sense not, if we consider
that we are now more than 30 years into a pretty aggressive campaign to
legalize marijuana, and the national public polling, public opinion
polling, seems to show that it hasn\'t really moved public opinion on
that issue very much at all, although there are significant regional and
even local differences.

I bring this up only to say that, as we are thinking about this, maybe
we are keeping in mind that, even where there is widespread abuse, some
taboos along these lines, but not others but some, have been maintained,
and in part reinforced, by countervailing social pressures.

DR. FRIEDMANN: I tried to finesse that a little bit by putting
\"acceptable\" in quotes. I hope that it was still there.

PROF. GEORGE: I did notice that.

DR. FRIEDMANN: But, also, I hope I didn\'t have cocaine. But the point
is that widespread use indicates something.

PROF. GEORGE: I agree.

DR. FRIEDMANN: And ours, of course, is not the only society that\'s
faced the use of those agents, and others have been more willing to buy
into them. So \"acceptable\" in this case means widely used, but heavily
debated still, and probably on their way to wider use.

PROF. GEORGE: Well, I stay with the point because I think an interesting
dimension of the problem is the question of inevitability, which was
raised at various points in your presentation. Obviously, if something
is inevitable, then thinking about how it can be restrained is a waste
of time, although it might be that you can think about how its use can
be channeled in certain ways or maybe even limited in certain ways. But
that is why I was interested in that problem.

Similarly, and I guess the answer is going to be the same thing, on a
couple of occasions you used the term \"universal,\" and I think I
interpret what you meant by that as, again, being widespread, the
universal use of drugs or the universal opinion among athletes that it
would be worth giving up a certain number of years of life ‑‑

DR. FRIEDMANN: I used that word it was wrong, about universal.

PROF. GEORGE: Now to the substantive matter, am I thinking about this
correctly? We have the health sets of issues when it comes to possible
attempts at enhancement; that is, the attempts themselves could end up
damaging the health of people who undergo the enhancement techniques.

Then separated analytically from that is the question of the ethics of
people, even if they are safe ‑‑ so laying aside their safety ‑‑ the
ethics of undergoing these enhancements or availing oneself of these
enhancements to be better athletes or to perform at a higher level. Am I
right to think that the ethics of that depends on the concept of sport
that is in play, on the, I think what you referred to, if I remember
correctly, as the old romantic version or concept that you grew up with,
you really do have an ethical problem, because the enhancements have
driven out what seems to be central on the romantic understanding, which
is drive, effort, perhaps natural talent in some sense.

But then on a different conception that puts the focus on, say,
entertainment, rather than the romantic conception, it doesn\'t seem to
be undergoing ‑‑ the enhancements techniques doesn\'t seem to be an
issue because the goal is to entertain the public. Mark McGwire, or
whoever, hits 70 home runs; the public likes that. Nobody has done
anything ethically wrong. Am I right so far?

DR. FRIEDMANN: I agree, yes.

PROF. GEORGE: Okay. Then I guess we get to this interesting question ‑‑
I remember the quotation you had up there from the basically baseball
historian who said, \"Well, look, if somebody wants to give up their
certain number of years of their lives or damage their health to hit 20
home runs, that\'s a private individual decision.\"

I think something in most of us wants to agree with that, that that is a
private individual decision, but I wonder if we ought not to agree with
that, not only the health question, but because it is not a private
individual decision what sport is going to mean in a culture. The
question whether the sport will have some substantial element of the old
romantic notion or be entertainment will itself, in a certain sense, be
the product of a lot of individual choices, but it is going to be a
social reality, for better or worse, a social good, if you will, that
all of us, whether we like it or not as individuals, are going to live
with. Is that right, too?

DR. FRIEDMANN: So far you\'re perfect.

PROF. GEORGE: Okay. Well, that\'s all I wanted, the only ‑‑

DR. FRIEDMANN: I mean, that is why I raised the question at the end. I
am not so sure any longer what sport is. What is sport, and, again, the
question of, what are we trying to protect from people\'s individual
choice to use performance-enhancing anything? It is not fair for me to
insist on my view of sport to the point where I say that it is improper
for Mark McGwire to use what he uses. I have a view of sport; he and
many other millions of Americans have a different view of sport.

But to the point where it begins to suggest the ways in which areas of
our society move from one realm to another and become entertainment or
become technology, if sport is going to move to the position of being
bioengineering ‑‑

PROF. GEORGE: This is what I find interesting.

DR. FRIEDMANN: \-- then it is a different world, and you may say, well,
that\'s too bad; goodbye sport and hello bioengineering. I would find
that sad, but I am not so sure on what basis I rail against it.

PROF. GEORGE: Let\'s, just for the sake of argument, say that human life
is enhanced, where the romantic conception of sport prevails, just for
the sake of it. Let\'s say you did believe that we could, then, explore
what the argument would be for that, but let\'s just say that that is a
good thing, and therefore, it would be reasonable for me to want that to
be available to my children.

DR. FRIEDMANN: As athletes or as spectators?

PROF. GEORGE: Well, both. Both. I want them to live in a world where the
benefits to them as athletes and spectators, of participating and
viewing that kind of human achievement, that kind of activity, are
available to them.

It looks to me like that gives me at least a reasonable basis for
rejecting the kind of strong individualism or ethic of choice in these
matters that would line up with what the baseball historian is quoted as
saying in your presentation: that it\'s really nobody\'s business if
this one guy, or every single individual athlete, decides that he would
rather have 20 home runs than another three years of life. Because that
set of decisions is robbing everybody else of the opportunity to make
available to their children, let\'s say, probably starting all the way
down in Little League, this conception of sport, since it turns out that
sport is itself a kind of social reality. And if it is a good thing, if
there is a conception of it that it is a good thing, it is a social
good.

DR. FRIEDMANN: I think one has to have faith in one\'s idols. When I was
growing up, I lived down the street from the Philadelphia Phillies
player who was one of the neighbors and just another person. I admired
him. He was an athlete, but he was another one of us.

I must say that in watching the Wimbledon tournament recently and
watching baseball games, I no longer know what I am seeing. In a way, I
feel a little bit robbed by not really have faith, not as much faith as
I had in my old idol of the reality that I am now seeing bioengineering
more than I am, and pharmacology more than I am sport. Maybe that\'s
inevitable. I use that word again, but sport is not what it was, and it
may be that we simply have to recognize that nothing is what it was.

PROF. GEORGE: You have a couple of children. When they were small, you
probably would have directed them or encouraged them into sport or not
into sport, depending on what it was that was being offered in sport,
right, whether the future was, if they wanted to get serious about it,
enhancements, whether pharmacological or genetic or not?

DR. FRIEDMANN: Well, one of them went into sport because he loved the
effort.

PROF. GEORGE: On the romantic conception?

CHAIRMAN KASS: I have Janet. There is something of a queue, and if it
begins to wander in every which direction, I am going to try to maybe
stick to some topic, but please, Janet, and then Gil.

DR. ROWLEY: Well, I am going to wander in a direction, but I am going to
take up on your last point of the last slide, which is enhancement in
other areas. This is a topic that we have talked about off and on here
in this Council, using examples like one which is germane to just what
you have been talking about. If somebody wants to have a child with the
skills of Michael Jordan, then you can start doing germ-line therapy for
enhancement for that child, or beauty or intelligence.

I guess I would like your opinion, because it has seemed to me that
these areas of enhancement involve complex genetic interactions about
which we are pretty ignorant, and that at least at the present time
those kinds of enhancements for overall athletic ability or intelligence
or beauty are not likely to be immediately a concern. But I would very
much appreciate your comments.

DR. FRIEDMANN: Let me make sure I understand the question. So the
question is genetic sort of germ-line modification for enhancement
purposes?

DR. ROWLEY: Yes, and have a superintelligent child. So is this something
that we are going to be able to do germ-line treatment for in the next 5
years, 10 years, 20 years? I mean, enhancement for sports is one aspect,
but I think many members of the Council are concerned about these other
areas of enhancement. So what does your crystal ball say?

DR. FRIEDMANN: I think nobody knows better than this group the
difficulties in even imagining how one\'s going to do that. All the
factors that go into defining one\'s intelligence and sportability and
everything else, they are imponderable at the moment. We know they are
genetic to some extent. We know there are non-genetic and environmental
and upbringing issues. We all know that one is not going to get a
Michael Jordan or a Beethoven or a Michelangelo who\'s going to care a
wit for what his genetic destiny might seem to suggest.

I mean, you make a Michael Jordan and he will probably hate sport. He
may be very tall, but he may turn out to not have the opportunities to
have learned basketball, not have the coordination which comes from
conversations among lots of other genes. I think that is a non-starter
at the moment because we are far too ignorant. There is just no question
about that.

This nonsense, I must say, about Ted Williams, of course, another
destruction of one\'s image of romantic sport, the nonsense of Ted
Williams being frozen so one can sell his DNA, so that one can produce
lots of other Ted Williams, it is absolutely \"klatsch,\" as the Germans
would say. It doesn\'t make sense, but, of course, that is not going to
happen. There is no scientific defensibility for that. I think that is a
non-starter.

CHAIRMAN KASS: Gil Meilaender?

PROF. MEILAENDER: Yes, as someone who could tell you what the Chicago
radio stations that do sports talk all day are, I think you are too
quick to assume a certain kind of tacit acceptance on the part ‑‑

DR. FRIEDMANN: I\'m sorry?

PROF. MEILAENDER: \-- to assume some kind of tacit acceptance on the
part of the public of, well, most recently, the steroids in baseball,
for instance. I think it is pretty far from that.

I wonder if I can get you to just try to help me think a little farther
than your presentation, which was very good and helpful. There are
certain kinds of things, certain kinds of advances we make in sport. You
pointed to them. So we start to use better tennis rackets, for instance,
or bigger baseball gloves, or something like that. Maybe for a little
while, if I have a better tennis racket and you have an old wooden one,
it advantages me, but then pretty soon nobody uses wooden tennis rackets
any longer, and all is well.

There is a sense, I suppose, in which you could say the same might be
true with some of these possible, in-the-future ways of genetically
enhancing performance. For a little while, if I have had access to it
and you haven\'t, you know, it is unfair, but then it evens out.

So if the issue is simply kind of a level field of play and competition,
if that is the issue, then probably, although there may be difficulties
in the short run, in the long run it might not be a big issue.

So what I want to know is, if that\'s not the reason that people, just
intuitively, seem to be concerned, and maybe they\'re wrong, maybe their
intuitions are just wrong, can we think a little bit more about it?
Because I don\'t think it is just the issue of health. Indeed, if it
were just the issue of health, I might actually be with Jerome Holtzman;
you know, if you want to give up 20 years of your life in order to be a
star, God bless you, sort of.

But is there any difference between using genetic-altering approaches to
enhancing my performance and using a bigger baseball glove or a graphite
squash racket or something like that? You know, these could all be
thought of as accomplishing the same thing in some ways, but do you
think about them all in the same way or do you distinguish between them?

DR. FRIEDMANN: I think they are the same if your endpoint is, how far
can you hit a baseball or how fast can you come down a ski slope, and
how fast you can run 100 meters. If that is the endpoint, just sort of
the measure, the quantitation, then you could say there\'s no
difference. On the other hand, if you are saying that there is a
difference between modifying the equipment and modifying the user of the
equipment, then I think there certainly could be a difference, that it
is engineering, sort of materials engineering versus bioengineering.

PROF. MEILAENDER: Well, I mean I understand that, but your sentence was
that there\'s no difference if you are only interested in how far you
can hit a baseball, but who is the \"you\"? See, when you went on to
your second distinction, the issue was precisely who the \"you\" is in a
way, you know, a bioengineered you or not.

So the sentence, \"There is no difference if you\'re only interested in
how far you can hit a baseball\" is systematically ambiguous, I mean,
because it cloaks the crucial question, doesn\'t it?

DR. FRIEDMANN: I don\'t know if I see that as a crucial question. Maybe
I don\'t understand it too well. If the only measure of the
manipulation, a wooden bat or a fiberglass pole, or whatever, if the
only measure is the end result, then you can say there is no difference.
But if you are looking at the way you got to that point, if it is
because the athlete himself has changed in fundamental engineering sorts
of ways, then having hit a ball 500 feet is one thing. If he\'s got
there by using a far better designed bat, then that is something quite
different.

The problem with Holtzman\'s analysis, Holtzman\'s comment, it seems to
me, is that that certainly is true, if the athlete, or if people,
subjects, whether athletes or not, are provided with full and complete
information on what is likely to happen. If their information, if the
available information is inadequate or is obfuscated or is not clear,
and yet they are being offered, just in the case of the East German
swimmers, offered long periods of pharmacological intervention based on
the promise that they are going to have athletic success, and yet at the
risk of their health, you can say to them, it doesn\'t matter what they
choose. If they choose to win over protect their health, that is up to
them. But it is only up to them legitimately if they\'ve got correct
information, if they have been educated, if they know what the options
are, what true options are for them.

In this case, I think the option is that genetic modification is too
immature a technology to assure the subjects that they will not be
harmed, that the issues are far too immature and the techniques are far
too immature, technology is too young, to know, in fact, what is going
to happen in 20, 30 years. That is a level of ignorance that you have to
be aware of if they, in fact, according to Holtzman, decide that they
would accept that risk.

PROF. MEILAENDER: May I continue for one minute or not?

CHAIRMAN KASS: Well, I was going to come to you, if I might.

PROF. MEILAENDER: Okay.

CHAIRMAN KASS: Because I think I might clarify this. I take it your
question is really not about the safety question or the health risks.
Your question is whether there is somehow a fundamental difference
between alterations, like I say, in one\'s equipment and alterations in,
which I guess is the debated question, in yourself, and if that is a
difference, whether we should care about it, I take it is where you\'re
going.

Let me try something with you, because in the article that was
distributed, Malcolm Gladwell\'s essay from The New Yorker ‑‑ I won\'t
get it right exactly ‑‑ but, in effect, he is suggesting that some of
these performance-enhancing drugs might, in fact, be a way of correcting
for the accidents of natural endowment, and that if the romantic view of
sport is based upon striving and effort, rather than on the basis of
some ideal of excellence as such, then it seems to me, why wouldn\'t you
want to say, \"Look, what really counts is what you make of your talents
and you can\'t take credit for your talents because those are gifts.\"?

Then why say, \"Look, what you really want to do to have real sport is
to equalize talent and then what you really want to see is, what are
each of us going to make, what is everybody going to make of the
talents, on the basis of who you really are, which is not the gifts that
you were given, but your discipline, your effort, your aspiration.\"?

Why wouldn\'t you then want to say, \"Look, body engineering is the
possibility of really leveling the field in terms of gifts, so that we
can then find out who\'s who when it comes to what\'s in the salt.\"?

PROF. MEILAENDER: There are some complicated questions there. Remember,
I began with a question. I wasn\'t making an assertion.

But why do you think that who I am has only to do with the soul and not
the body? Why do you think that who I am has nothing to do with the body
that I have and the natural endowments, and so forth?

Well, just, you know, hang in there. Is it not, therefore, possible that
we can conceive of certain kinds of alterations of the body that seem to
alter the who I am? I mean that is the issue. And I don\'t have an
answer here, but I am not just prepared to accept the disjunction.

CHAIRMAN KASS: But then your view of sport is that it is not ‑‑ then the
excellence isn\'t just in the striving.

PROF. MEILAENDER: Why, no. I coached kids, baseball teams, for years,
and I never told one kid that it didn\'t matter whether you won or lost.
I wouldn\'t tell a kid that at all.

DR. FRIEDMANN: I\'m not so sure I buy the issue that you quote in the
article about sort of leveling the playing field to make up for
people\'s innate differences, innate differences in talent or ability,
because that assumes that there is kind of a finite and defined normal
for that. We all know, of course, that that, like everything else, sits
along a very long wide spectrum of human capability, human traits.

People at the low far end of the normal curve are going to have very
different traits from people at the high far end of the normal spectrum.
So is that fair? Is that just, that they have got to compete with each
other? So why not, in fact, imagine getting everybody to precisely the
same level and have no curve, have just sort of a single point which is
acceptable? That\'s not going to happen. So the level playing field
concept, get everybody to the same level of capability and then see who
runs the fastest, I think that is not going to be feasible.

CHAIRMAN KASS: Frank, Charles, Michael, and Paul are in the queue.
Frank?

PROF. FUKUYAMA: Two separate points. With Gil, I think the health ‑‑ I
mean, I just find it hard to believe that health is the only ethical
issue. I am wondering if there is actually any empirical polling data
about why people oppose doping.

DR. FRIEDMANN: Why they oppose?

PROF. FUKUYAMA: Yes. You know, at the beginning of \"The Prime of Miss
Jane Brodie,\" she is a school teacher and she sees a sign on her wall
that says, \"Safety first,\" and she rips it down and she says, \"No,
honor, virtue, courage first. Safety second.\" That\'s the choice. Like
Gil, I\'m with the athletes, but that is just one issue.

But the second one is, I wonder if you could speculate a little bit with
me. Supposing that you moved sport from the romantic version completely
and made it more like auto racing, where it is a team effort of a bunch
of doctors and medical people, to enhance the abilities of the athletes,
that we kind of accepted that that is the ground of the competition,
like the America\'s Cup or something, and it is a kind of open-ended
competition.

What would happen in that kind of world over time? Would you move
asymptotically simply to a kind of natural limit and just get there
quicker than you would by normal training and the kinds of things that
have traditionally been done in athletics or would it lead to a world,
basically, where you would have, for example, an increasingly freakish
number of body types?

I mean, already it is the case where football players and Sumo wrestlers
and basketball players are look physically quite different, but you
could imagine that, with the kinds of biomedical technologies that
we\'re going to have in the next generation, you could push those
somatic types in really, really far so that, instead of slam dunks, you
would basically have basketball players that are dropping basketballs
downwards into hoops.

But what does that world look like? Have you given any thought to ‑- I
mean, do all athletes become Sumo wrestlers, kind of grotesque Sumo
wrestlers, in a sense, or is it just a kind of convergence on a natural
limit that ‑‑

DR. FRIEDMANN: I must say I haven\'t given it more thought than your
very perceptive question indicates. You have the same intuition that I
have, that the second option isn\'t very pretty. If one wants to go
there, then I keep thinking again of Schrecker, what does that make of
sport? What is an athlete at the end of all that, if not just simply
another byproduct of a piece of engineering?

It is not sport, I presume. I am not an athlete, and I am new to the
anti-doping world. But I have had trouble, as you have, understanding ‑‑
and that is why I put it on one of the slides ‑‑ what it is that we are
so worried about. What are we protecting sport, for its own best
interests, or are we protecting sport because we have the view of sport
as we remember it growing up that we would like to see never change?

I don\'t like looking at a sports competition wondering what I am
looking at. If I am looking at the highly-engineered body, then that is
one thing, but if I am looking at an athlete, I would like to see
something else.

That is my problem, I think. It is not the athlete\'s problem. It is not
the society\'s problem.

CHAIRMAN KASS: Charles?

DR. KRAUTHAMMER: Let me try to address the problem, the question that
you just raised, what are we worried about and why are we concerned
about this? I don\'t think our concern is about sport. We are not a
commission on sport; we are a Council on Ethics. Sport is very useful.
Your presentation was very enlightening because it is such a clear sort
of pure culture of the question. Things can be measured. We know that
enhancement is possible. We know that enhancement has already occurred.
So it allows us to look at the larger issue through a window that we can
understand.

But I am not sure that the aesthetics of sports is the critical issue. I
think the real critical issue is, why does enhancement somehow bother
us? As I look at it, I think there are three possible reasons: safety,
fairness, and character. Safety is obvious, and that is sort of a given.
We are a society that protects people from themselves and the use of
drugs or other areas; it would carry over into here. I don\'t think it
is a very interesting question.

The more interesting issue, I think, is the issue of fairness. Gil
raised it. I think he gave one explanation, which is that we ought not
be that worried about the fairness because, as in the mechanical
technology, as in tennis rackets, in the end if all the competitors are
using the same enhancement, the fairness is retained. What\'s unfair now
is that you\'ve got doping being illegal; some know how to cheat and
some don\'t. If you lived in a world in which it were either completely
abandoned and enforced perfectly or allowed and universally used, you
would end up in a situation where everybody is using the better tennis
racket or the better body. The fairness issue, I think, would not be the
major issue.

The other aspect of the fairness issue was raised by Leon. In a sense, I
think he is right; the enhancement can be seen as a corrective for the
unfairness of natural endowment. It is not quite clear why we honor
people with great talent. It is useful in a competitive society, but why
it is honored, if the talent, in and of itself, is innate is an
interesting question. If enhancement is a way to level the field, I am
not sure it offends our sense of fairness.

In the end, I think the reason that we object to this enhancement, or at
least have some initial ‑‑ why we recoil from it initially has to do
with character. I think it is a sense that that is not the way to get
from A to B. I mean, the ultimate enhancer was Rosie Ruiz. Do you
remember Rosie Ruiz? She won the New York Marathon one year by riding
the subway for the 18 miles in the middle. She started the race, got on
the subway, waited a while ‑‑ that was smart ‑‑ and then rejoined it for
the last mile. Her crown was only temporarily held.

(Laughter.)

But it offends us because that\'s not how you do it. In the end, I think
when we discuss enhancement and make recommendations, or at least raise
issues about it, not in sport but in life, because I think that is
really what is important, is going to be this issue of character, that
it is a cheap way to achieve what ought to be achieved by other means.

I am not sure how defensible that objection is, but I think in the end
it is what underlies our objection. It is not safety. I am not sure in
the end it is fairness. In a sense, it is character, I would say.

CHAIRMAN KASS: Michael?

PROF. SANDEL: Well, I think Charles has advanced the discussion. He has
partly stolen some of what I was going to say, but I think that this is
onto something important to separate safety and the fairness
considerations from some other objection that we have, but find
difficult to articulate.

During the last Olympics I was speaking to someone. He works in the
biotech. industry. He said he wasn\'t watching the Olympics. I asked him
why, and he said, well, he didn\'t really know what it was for, what it
was about. Here were these people lifting huge weights, and there was
all this discussion about enforcing anti-doping regulations, but if the
purpose of the competition was to press the limits of human achievement
to see what the people could do with the human body, then the logical
thing to do would be to allow people to use whatever enhancements were
available because that would be the way of pressing the limits of human
achievement: how much weight could be lifted, how fast a hundred meters
could be run.

But, given the inconsistency about the forms of enhancement, rigorous
training regimes, okay, but pharmacological or genetic interventions,
not okay, given that inconsistency, there was an incoherence introduced
into the nature of the sport. Therefore, he didn\'t watch it.

I thought this was a bizarre reaction, a bizarre view, but I think he
was onto something, just as I think Charles is onto something. I don\'t
think it is true that the classic or romantic idea of sport is based on
striving or effort. That misdescribes it.

In fact, I think there are two ideals that coexist uneasily in the
classic conception of sport. One of them has to do with effort and
striving, but the other has to do with achievement and excellence.
Different people, maybe as a matter of temperament, admire more the one
or more the other.

People who greatly prize and honor effort and striving will say that
Pete Rose was the greatest baseball player who ever lived. He wasn\'t
blessed with great natural gifts, but he was gritty and determined and,
through sheer expenditure of effort and will, managed to be a great
baseball player.

Whereas, others are drawn more to Joe DiMaggio, who was blessed with
great gifts and grace, and part of what people admired about his play
was precisely its effortlessness and the grace that went with those
gifts.

So the second ideal, the one that\'s in tension with striving and
effort, has to do with gifts, the great gifts that we admire when, of
course, they are properly cultivated and displayed by great athletes. We
saw the tension between these two stances, these two dimensions, of the
ideal of sport in the celebration of Ted Williams. They told the story
time and time again about how he practiced hitting until his hands bled.
That was effort. That was striving.

But, at the same time, he was celebrated and valorized for having such
terrific eyesight, 20/10 eyesight. They said again and again, that he
could read the signature of the League President on the ball as it came
forward. That had nothing to do with striving or effort. It had to do
with a gift, but the gift and the way it was deployed in the excellence
is something that we admire wholly independent of the striving. But that
raises the question, because now we have laser eye surgery that many
athletes go in for, Tiger Woods famously among them, that can change and
correct and improve the eyesight that sports figures have.

So if we have, then, these two ideals and tension in sport, the
question, an interesting question going back to the technological
intervention, the enhancement, is, what exactly is threatened? What
dimension of the ideal of sport is threatened insofar as we are uneasy,
for reasons that go beyond safety and fairness in the case of sport?

Our first instinct, I think, is to think it is effort and striving.
Because of someone goes and gets a technological edge or takes a drug,
then they are doing something that they really don\'t have to strive for
and train for. It\'s training on the cheap.

But I don\'t think that is really what bothers us about the biotech.
enhancement. It is more deeply a threat to the second, not the first.
Because what it displaces or confuses in what we honor and admire in
sports is the appreciation of the gift, the gift of the great athlete
which, when cultivated and deployed, leads to an excellence that we
admire.

In fact, the intervention, the enhancement of genetic or pharmacological
enhancement is in some ways a ratcheting-up of the element of will, the
first thing. It is carrying the idea of will to a kind of logical
extreme, and so it threatens to crowd out the sense of gift, the great
athlete a gifted. There it seems to me it is in crowding out the sense
of gift that this deep, independent, morally-troubling threat consists.

Now it is a further question, and Charles raised it very well, why we
are so interested in using sports as a metaphor or as an analogy for
trying to understand objections we might have to enhancement in the
wider society. I think that is a question we need to think about, but
here\'s just one speculation:

Sports has become increasingly a metaphor for life, as the allocation of
rewards and honors in our society, as we search for a rationale. We like
to think of ourselves as a meritocracy, but a meritocracy is at odds
with the idea of honoring or rewarding gifts or giftedness. So we tend
to describe the system of social rewards as it is rewarding effort; if
you try hard, you have an equal opportunity, you can get ahead and be
rewarded. That is what we honor.

So, if anything, we have kind of refashioned ‑‑ and we saw it in the
discussion here ‑‑ we have refashioned the ideal of sport to fit the
image of the society, that we have this meritocratic one based on
effort, and yet we know with another part of ourselves, I think, that
the distribution of honors and rewards in our society can\'t wholly be
made sense of in terms of effort alone. That makes us uneasy, and it may
get all the more complicated when we imagine a kind of genetic or
pharmacological arms race, not only in sports, but also overlaid on a
meritocracy, where we are not quite sure to what extent we are honoring
effort or honoring achievement and gifts for which we can claim no
credit.

CHAIRMAN KASS: Thank you.

DR. McHUGH: I always come after Michael, and I am so impressed by what
he said, I have lost my track a little bit. I want to simply go along
exactly with what Charles and Michael have been alluding to, but to make
some simpler points along the way. I think, Dr. Friedmann, you have made
some of them as well.

But, fundamentally, what we are all concerned about is that which we are
going to permit is going to have to be required eventually. I had a dear
friend of mine who is a wonderful psychiatrist, who is a wonderful
person, and he was involved with the professional football team in San
Diego. He discovered that all of the defensive players were on
amphetamines, and he wanted to get them off of the amphetamines. They
all said to him, \"Doc, can you imagine what it\'s like me going out
into that field with those guys who are drooling with their
amphetamines? You\'ve got to help me to get through.\"

The problem for my dear friend, and he is a wonderfully gifted person,
is that he tried to help them, and help them reduce their amphetamines,
and at the same time kind of keep them in play, and eventually hurt
himself in the process, very much hurt his reputation. But that was the
first example to me of what is permitted will eventually all be
required.

I agree also with what is being said, that one advantage of looking at
sport ‑‑ I mean we are not here to talk about sport, but sport does give
us a little opportunity to look at what could happen in other arenas.
One of the things that is being left out of discussion here is just the
plain word \"cheating,\" you know. Doesn\'t cheating perhaps apply here,
just to get to the groundrules?

Now take another game that takes very little athletics ‑‑

DR. FRIEDMANN: But you can have that and have achievement at the same
time.

DR. McHUGH: Yes, that\'s right, and I want to talk about exactly that.
There\'s a game that we know in America, and we know what constitutes
learning about the odds and playing it well and folding when you ought
to. We also know that if somebody spends a lot of time learning how to
slip cards up his sleeve and play that way, that we shoot those guys
because that\'s wrong. It takes away the whole idea of the game and what
it is.

I very much, with you, believe that the thing that has gone wrong for
lots of people is that we have an immature science that we are telling
them, nobody can get ‑‑ everybody is going to have to join up. What\'s
given is required. Yet, the science is so poor, we can\'t tell them
exactly what\'s going to be lost in their health.

But, ultimately, it does come down, well, for me, and I suppose I do
have a romantic view of sport; I certainly spent an awful lot of hours
in my life talking about sport. When Ted Williams died, I burned up the
phones spending dollars talking to many people all around the country
about what a terribly sad day it was and how I saw him hit the Eephus
pitch and all of this. Because I thought, and still think, that part of
the thing that sports gives to us is that it enhances our capacity to
appreciate excellence in others and their character as they use what God
gave them to achieve all the things that they have achieved.

If we permit all this genetic enhancement to go, that there will be not
only a loss in physical things, but we will lose the sense that there is
a place where character counts. If we lose that, then in the boardrooms
of the country and lots of other places, where character ought to count
again, it will be lost there, too.

PROF. SANDEL: Of course, cheating is what we are against.

DR. McHUGH: Yes.

PROF. SANDEL: But isn\'t the issue raised here, what counts is cheating?
For example, if we go to the wider society, apart from sports, when kids
who can afford it take courses to prepare them for the SATs, is that
cheating?

DR. McHUGH: Well, as I am saying, I am not sure exactly where cheating
ends and where cheating begins, but I know it when I see it.

(Laughter.)

Consider poker. That\'s one of the reasons I wanted to talk about that.

PROF. SANDEL: I didn\'t know what game you were referring to, so I\'m
glad you named it.

DR. McHUGH: Yes, you were wondering, I\'m sure. But you can consider
games of that sort.

No, I agree with you that there are ways in which you might wonder that
we are not a completely equal society in lots of ways. Some people can
have, just the case of baseball, some people can offer their kids a
batting cage and a batting machine, a pitching machine with which to
play early on, and they don\'t have to do like Ted did, go out into the
dusty fields of San Diego and get somebody to pitch to them. I
appreciate that.

On the other hand, I think that we should be able to say at some point
that certain forms of enhancement just go beyond what is, and I think
lots of things that are happening in genetics go beyond there. Although
there are gray areas, there are still areas of black and white.

CHAIRMAN KASS: We are going to wind up shortly. I have Bill and then
Frank, and I want to give Ted a final comment. Then we will stop. Bill
Hurlbut.

DR. HURLBUT: So cueing off of what Michael said, I want to suggest that
we institute a third kind of Olympics. We have the normal Olympics and
the Special Olympics. Maybe now we need the Bio Olympics.

DR. FRIEDMANN: That is not as facetious as you may imply. There is
already talk for sort of an enhanced weight-lifting set of events.

DR. HURLBUT: Well, I, for one, will be much more interested in watching
the normal Olympics, if they do it, as I am now more interested in
watching Little League than professional baseball.

I think when you mentioned the ‑‑ I have to confess I am a romantic on
all this, but I think that might not be so cultural as it is more deeply
universal, picking up on what Robby said earlier. I teach at Stanford.
We have a lot of Olympic athletes, and I have had them in my classes. It
seems to me that there\'s something important going on here that we\'ve
kind of touched on, but maybe not quite completely.

Obviously, there\'s something entertaining about watching eccentricity
and novelty and extreme, but this is kind of ‑‑ I don\'t know, I see
this as almost a societal auto-digestion, where we are deriving
entertainment from things that are destructive, a kind of nourishment
from our own destructive deformation, rather than what I think sports is
about, which is something that has to do with something profound and
noble and moral, quintessentially moral.

It is not health that strikes me. I think about, what would you approve
using enhancing drugs for or even entering into territory of danger for?
I think, for example, about a hand surgeon, I mean an eye surgeon doing
an operation on a child. You wouldn\'t mind him using beta blockers to
calm his hands for that, even if it was a little bit of a health risk to
him. We send people out into space with NASA, and we don\'t mind the
health risk of that. It seems to me it has something to do with serious
purpose.

Even with my students, I talk to them about all this. When it comes to
things like cosmetic surgery, they feel okay moving kids with
deformities up to the norm, but when you start moving beyond that mean,
they are uncomfortable with it. They feel like something has changed.

When it comes to sports ‑‑

DR. FRIEDMANN: Is it the mean or ‑‑

DR. HURLBUT: Or the norm.

DR. FRIEDMANN: Yes.

DR. HURLBUT: I mean whatever you call it, in the middle. They are okay
if you move a kid with cleft palate up to looking normal, and they are
okay even with taking a person with ears that stick out or a recessed
chin or something, but when it starts to become a competitive action,
they feel like it is no longer medicine, that it is somehow strangely
moved into the realm not of social coherence, but of competition.

It seems to me that that is what is going on in sports enhancement that
bothers me personally. Maybe this is more universal than me; I think so.
Sports is a kind of symbolic combat, but it seems to be a moral combat
fundamentally. You spoke of an aboriginal impulse.

If you go back and you look at Murdoch\'s human relations files ‑‑ do
you know about those? They did these ethnic studies across all cultures,
and every culture has something in the way of a sports ritual. Often
they are tied in with the rites of passage.

I wonder if maybe at this particular age group that sports involves,
primarily this risk notion has something to do with confronting the real
world as it is, confronting danger, confronting infantile impulses and
all the persuasions of pleasure, and in the constellation of that we
gain control over ourselves.

In that sense, when I watch an athletic event and I see somebody
manifesting self-mastery, that seems to me to have a moral element to it
that is quintessentially the essence of morality in the first place;
that human beings exist in a world of striving and struggle within their
open possibilities and indeterminacies, and they move in a moral
direction when they move for serious purposes against the natural
quality of giving in to the easy or the obvious.

In that sense, it is not just effort that we care about. Ultimately, it
is what is done. That is why to me all the things that we are talking
about in terms of enhancement seem like they might be more okay at
least, and maybe okay, when done for serious purposes. But the problem
with sports is, instead of being a communal matter, it becomes a purely
individual competitive matter then. It changes its character from being
a place where we come together as a society to being a place where we
lose the essence of what it is to be moral.

Does that make any sense?

DR. FRIEDMANN: I think that\'s a good analysis, but it flies in the face
of the analysis of sport having multiple characters. One is striving and
effort; the other is achievement. If achievement, in fact, is
achievement and excellence or, in fact, the calculus by which sport is
measured in a society, then it seems to me you don\'t have much of a leg
to stand on.

DR. HURLBUT: Doesn\'t it become boring when it is just about
achievement?

DR. FRIEDMANN: Well, of course, it\'s boring, but we presume that, to
some extent, effort and striving ‑‑ or at least how do I get to Carnegie
Hall? Practice, practice, practice. No one ever said, take something to
help you get there. In fact, most violinists probably take beta blockers
to keep the quiver down.

So I think that the question really, again, is, what is sport and what
are the goals of sport? I don\'t mean in any way to say that this is the
moral problem of our time, but I think it is an opening to the issue of
what do we take for being normal; what do we take for being acceptable?
And those things that we want improved, what is it that enhancement is
designed to do for us? What kind of enhancement do we want, and what
kind of enhancement is morally repugnant to us?

That, of course, all depends on what we think sport is. If it is a
paradigm, that is one thing. But the issue of enhancement outside of
sport is still a major concern.

CHAIRMAN KASS: Frank, absolutely the last; I\'ve kept everybody after
school.

PROF. FUKUYAMA: Okay, well, very briefly, I thought Michael\'s
distinction between gifts and effort was a very good one, but it does
seem to me that the concept of gift and reveling in the excellence of
that gift has to be related to some concept of what it means to be a
human being. It is a human gift.

What you find remarkable is that a human being can do this in a human
way. If you\'re born as a freak, you know, nine feet tall and you can
play great basketball, I don\'t think ‑‑ and then, similarly, we don\'t
revel in cheetahs because they can run faster; they can run the mile
faster than human beings because that\'s what cheetahs do. So there does
have to be, I think, a specific notion of what it is to be a human
being, and the gift is in relation to our expectations of that.

CHAIRMAN KASS: The hour is late. I usually teach in the afternoon, when
I used to teach ‑‑ it is a life for which one longs ‑‑ from 2:30 to
4:30. I taught at 2:30 to 4:30 because, if I wanted to run over, nobody
wanted the room.

I have done it to you again. I promised an early start, but, Ted, you
have provided the foundation for what is in some ways, I think, one of
the most interesting conversations that we have had here as a group. For
the illumination and the stimulus, we are in your debt and thank you
very, very much.

We will meet tomorrow morning at 8:30 for the discussion of the Richard
Selzer story. I have good news for the wonderful people who have sat
with us through this day. Whether you come back tomorrow or not, if you
do, you will have a chance ‑‑ the text of the story we are going to
discuss is out there. So you can take it home, read it, and at least be
in on the conversation. That is the gift of our appreciation for your
endurance here and participation. We thank you also.

Thanks to Council members, and the meeting is adjourned.

(Whereupon, the foregoing matter went off the record at 4:42 p.m., to
reconvene the following day, Friday, July 12, 2002.)