UNITED STATES OF AMERICA

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THE PRESIDENT\'S COUNCIL ON BIOETHICS

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THIRD MEETING

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FRIDAY

APRIL 26, 2002

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The Council met at 8:30 a.m. in the Dewey Rooms of the Hilton Crystal
City, 2399 Jefferson Davis Highway, Arlington, Virginia, Dr. Leon R.
Kass, Chairman, presiding.

PRESENT:

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

ELIZABETH H. BLACKBURN, Ph.D.

REBECCA S. DRESSER, J.D.

DANIEL W. FOSTER, M.D.

FRANCIS FUKUYAMA, Ph.D.

MICHAEL S. GAZZANIGA, Ph.D.

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

MARY ANN GLENDON, J.D.

ALFONSO GOMEZ-LOBO, Ph.D.

WILLIAM B. HURLBUT, M.D.

CHARLES KRAUTHAMMER, M.D.

WILLIAM F. MAY, Ph.D.

PAUL McHUGH, M.D.

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

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

MICHAEL J. SANDEL, D.Phil.

JAMES Q. WILSON, Ph.D.

A-G-E-N-D-A

[PAGE]{.underline}

Session 5: Enhancement 1: Therapy 3

vs. Enhancement

Session 6: Regulation 1: Regulatory 77

Approaches to New Biotechnologies

Session 7: Public Comments 127

Adjournment

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

(8:36 a.m.)

DR. KASS: Why don\'t we get started.

Today we are shifting gears somewhat to take up for the first time two
new topics ‑‑ the question of enhancement versus therapy and questions
of regulation ‑‑ both sessions undertaken as pilot conversations to see
whether there is something in either or both of these topics that would
warrant serious attention by the Council in the future.

There\'s a lot to say about this. I will say just a little at this
stage, and really want to see how the conversation goes. First, there is
a sense in which the two things we\'ll be talking about today could be
seen as not discontinuous with our interest in cloning, which, although
we\'ve spent the better part of our time wrestling with the question of
cloning for biomedical research, the major interest in this topic to
begin with is cloning for producing children.

And one of the reasons why it is of concern is at least some of us see
it as the first instance of possible multiple ways in which one
generation could exercise genetic selection over the next with a view to
its improvement. And also, the discussion we will have about possible
regulation of biomedical technologies is one way into the public policy
questions of which we also ‑‑ we have yet to take up in an explicit way
with respect to the question of cloning.

In the cloning case, the public policy option at least on the table is
one of legislative prohibition, but the public policy options open to us
in this field are much broader, and we have yet to have that broader
conversation which we will do today.

On the other hand, if there is continuity between the subjects of today
there is discontinuity, if not in the subject matter at least in our
approach to it. Curiously to at least this observer, the subject of
cloning which first became a hot topic several decades ago in the
context of possible eugenic possibilities of producing superior human
beings or replicating them now is taken up primarily over the ‑‑ as a
matter of a new and benign treatment for infertility in certain cases.

When we take up the question of the possible implications of going down
the road of cloning for biomedical research, we think primarily of the
benignness of the ends of medical therapy and bracket to the side other
possible uses that might be made of the powers that are available here.

And when we take up the ethical questions there, the primary question
has been about the ethics of the means, which is to say, what happens to
the embryos that are produced in this ‑‑ in the research?

We have adopted generally a case-by-case approach in thinking about
these matters. It\'s perfectly understandable because these technologies
come to us one by one. We are reluctant, at least some of us are
reluctant, to look too far ahead, partly because it\'s uncertain where
things are going, partly because we\'re practical-minded and don\'t want
to engage in speculation where there are clear practical issues before
us.

And I sense that at least some members of the panel are unwilling to
allow ‑‑ unwilling is too strong ‑‑ are nervous of allowing fears about
future shock to imperil the present science. And yet I want to suggest
that the reason that maybe not ‑‑ the reason that we are here not
necessarily as individuals, but the reason why the public is concerned
about the kinds of questions that give rise to the field of bioethics is
‑‑ and, therefore, too, in a sense, the existence of a panel like this,
is a real concern about where biotechnology might be taking us in the
large.

And as Charles said at a previous meeting, his concern is less with
where these powers come from, but the uses to which they might be put.
Not only are we concerned, if we are concerned ethically, about the harm
to newborn children made of cloning, or about the embryos that might be
lost in the process, but about what we might do to ourselves and to
others when we start to use the powers biotechnology makes available for
purposes beyond the treatment of individuals with specific diseases and
disabilities.

The promise ‑‑ I think the concern that is on people\'s minds is if you
put it in the extreme form, the promise, if you like it, or the horror
of some kind of super or trans or post-human future, where the prospects
of ‑‑ in the mouth of the proponents ‑‑ some kind of superhumanization
or improvement of the race or dehumanization if you worry about the
consequences is at issue.

And I think, as it\'s been said before in the meetings, we somehow
recognize whichever side we are on the question of cloning for research
that there are powers available here and ideas that are afloat here that
will affect what it means to be a human being, not only from the
technologies but also from the underlying ideas.

And as it happens, this morning\'s Washington Post, in the Style
section, which indicates where these things get taken up, there\'s a
story on the next generation where bio-cyborg, etcetera, man is
introduced, and it shows you what\'s happening. I mean, I have never, in
25 years of being in a classroom, brought a newspaper ‑‑ bring some
reference of, you know, Rousseau or Tolstoy or something like that.

But here let me just say here are questions put before us about the
possibilities of changing our species, not because anybody is heading
deliberately to do it. But what would parents do when offered something
that would increase their child\'s SAT scores by 200 points? And I
don\'t think he has in mind genetic engineering, but certain
pharmacological things of the sort we might talk about.

What will athletes do when they are encouraged by extreme big-buck
leagues to have medical pit crews? What will fat people do when offered
an implant that will monitor and alter their metabolism? What will the
military do when it can overcome the need for sleep? What will the aging
do when offered memory enhancers? What will babyboomers do when it
becomes obvious that Botox and Viagra are just the tip of the iceberg
for the pharmagenetic sex-appeal industry?

Supposing technology allows us to transcend seemingly impossible
barriers, not only for ourselves but exponentially for our children?
What price does trans-human wisdom and power demand?

Now, hyperbolic, journalistic we can I think easily detach ourselves
from this if we would like. But I would suggest that it is I think
incumbent on the Council at least to explore the possibility that there
is something here worthy of our attention. And the question comes to us
usually in this form. What should we think about, and what should we do
about the uses of these powers when they go beyond the accepted medical
norms of healing disease and relieving suffering?

And what, if anything, could be done about this, even assuming that we
would like to? Hence, the question about enhancement. Hence, the
question about regulation. I think this is a natural context for this.

The question about the so-called brave, new world problem usually comes
to us in the somewhat tepid form of the distinction between enhancement
and therapy. Enhancement is a rather sanitized name perhaps for what in
the mouths of some people is a much more grandiose hope and aspiration.

And I think Council members have been sent a very interesting new book
by Gregory Stock called Redesigning Humanity. Stock is a physician,
scientist, and futurologist of sorts. He at least has the courage to lay
out what he thinks is coming for our consideration.

You don\'t have to like his point of view on it, but I think it\'s a
useful thing to think about. It may be excessive. It may be not. But
I\'d be interested in your reaction.

For this first session, we\'re going to have a preliminary go-around on
this topic of enhancement, to ask ourselves whether this is a useful
distinction therapy versus enhancement, to see whether it matters to us,
and then to try to do so in the light of some concrete cases that have
been put forth as possible exemplars for consideration of this topic.

The staff has prepared a working paper that you have in your briefing
books that, in fact, explores some of the ambiguities in the terms,
makes an argument as to why it still should matter to us whether this is
the right term or not, and then gives several examples.

And I would just simply like to open the floor for reaction to the
working paper and to this topic.

Paul? Paul McHugh?

DR. McHUGH: Yes. Well, you asked me if I wouldn\'t try to kick off
something. First of all, in the reaction to the working paper, I like
the working paper. It does develop ideas sufficiently far for us to
carry on a coherent conversation. It makes very useful distinctions in
relationship to certain aspects of therapy and enhancement.

What I miss from it and from the other articles here is any
understanding or any clear description of just the several domains of
therapy. Okay? Before enhancement.

And you said, for example, Leon, to begin that therapies can be
construed easily if we think of healing disease and relieving suffering.
But the issue of what you call disorder that comes to a doctor and
particularly, by the way, to a psychiatrist can have several distinct
realms of enterprise and distinct issues in relationship to disorder and
health.

And if you just looked at them in a simple order ‑‑ I don\'t want to
lecture you too much on this ‑‑ but I do think the important thing
before we talk about enhancement is we do know in what ways therapy ‑‑
appropriate therapy is now available and is used by doctors and everyone
accepts these as therapies, even as they begin to merge on the issue of
enhancement.

First of all, a therapy for a symptom or sign that can be tied to a
structural or functional abnormality of the body is therapy flat out. It
is talking about your disease issue. And that would be the therapies,
for example, for pain management or, as was nicely shown in the working
paper on dwarfism, a growth disorder in which you can show that the
person\'s sign, namely a lack of growth, is due to a lack of hormone.
And the replacement of that hormone is an appropriate treatment.

Now, by the way, with further advances in medical science, more and more
appropriate disorders that have a pathophysiological basis related to a
structural or functional abnormality will come forward, we\'ll find more
of them. But those are not the only therapies that we work on.

For example, there is an appropriate therapy for motivational drives
that are strong enough to overwhelm resistance and produce destructive
behavior. For example, gastric stapling for the obese and overeating. We
think of that as an appropriate treatment now, protecting people from
the obesity that brings it ‑‑ brings with it other disorders.

But there is appropriate treatment for the sleep disorders like
narcolepsy. And for those induced disorders such as nicotine habit, we
use Nicorette gum. And even with the paraphiliac disorders we are now
using Lupron and other things to reduce the sexual drive. And we see
them as appropriate therapies.

The third area is therapy for the dispositional traits that hinder
adaptation. And here we begin perhaps to think in terms where
enhancement comes into play. But there is no question that Ritalin for
the condition attention deficit disorder has been useful. And we are
still exploring the place of Prozac in relationship to certain neurotic
tendencies and disorders.

And although my friend Peter Kramer has talked about cosmetic
pharmacotherapy, there probably are psychological dispositions for which
an appropriate treatment is available. After all, by the way ‑‑ and it
might not be a therapy ‑‑ but all of us use ‑‑ many of us use a compound
that helps us to be a little bit more talkative at parties. And one of
them was used on me last night, and I was probably a little too
talkative.

(Laughter.)

And a little coffee to wake up.

But to go from dispositions ‑‑ to go from diseases to motivate to drives
to dispositions, and then there are therapies for intense human
emotional reactions to life stresses. And here you might think in terms
of enhancement, but antidepressants used for people in the throes of
serious and deep grief and even sometimes sedatives for life tensions
that are occasionally abused, but can be justified in some patients.

It\'s after that that you come to the cosmetic and health therapies ‑‑
cosmetic and health therapies, again, that we wouldn\'t ‑‑ that begin to
border on enhancement but, gee, we wouldn\'t want to do without them for
appropriate treatment. I mean, after all, orthodontia is an appropriate
cosmetic therapy, but it also has health benefits. Facial, bodily
cosmetic surgery, again, you might wonder about them, but encouraging
face lifts or encouraging cosmetic facial surgery to help people I think
is not simply enhancement.

Viagra now ‑‑ it\'s got a bad press, but it is a cosmetic or a health
therapy that I think enhances life circumstances in many cases. And then
we come to the therapies on demands that are pure enhancements. I want
to be taller, stronger, faster, brighter, and it\'s there that we really
can see that the enhancement issue comes into play.

I\'ve had two encounters with both ‑‑ with those things. One of them was
a personal one when I was a small person in Massachusetts, and somebody
suggested to my father I should have human growth hormone. And,
fortunately, my father said no. And if he had said yes, at that time
those ‑‑ those hormones carried with them in many cases
Creutzfeldt-Jakob disorder, as you know, afflicting people who later ‑‑
who grew but ‑‑ and my father said he was small and I was going to be
small, and it would be all right.

(Laughter.)

And now I talk with you, with the group, is, as you know, there are ‑‑
and these are ‑‑ these would be enhancement issues, because I was not
outside of the envelope that Richard put nicely together.

The other one is that with ADHD or the attention deficit disorder issue
being clear amongst young people, there are ‑‑ amongst the intensely
interested young people, interested in being sure that their SAT scores
are high, there are in a number of private schools minor, and sometimes
rather major, epidemics in Ritalin use as the Ritalin gets shared
around. And I\'ve had several patients who have developed addictions to
the drug.

So my point only is that if we\'re going to talk about enhancement let
us be very sure that we know what therapy is and just wrapping it up
with the idea that there is ‑‑ that therapy is for diseases and
everything else would be enhancement might make ‑‑ might close off
opportunities to see just what doctors do for benefits of patients.

DR. KASS: Thank you very much.

Mary Ann, please.

PROF. GLENDON: I do think it\'s very important to discuss this aspect of
the problem, and I would say not just for the future but right now in
our current report. And I thought the paper was wonderful, but there are
two dimensions that I hope we would add ‑‑ demographic and economic. Let
me explain what I mean.

I think that we need to, for the purpose of understanding what is likely
to happen in the near future in this area, we need to talk about the
aging of the baby boom generation and the very likely increased demand
for services that are more on the enhancing end than on the therapeutic
end.

And on the economic side, I can\'t help thinking yesterday and today
about a conference I attended two weeks ago on globalization and poverty
and wondering how these conversations would sound to somebody from a
poor developing country, and especially in the area that we take up this
morning.

It seems to me that if someone were here from a part of the world where
many people don\'t live long enough to have expensive diseases they
might truly be astonished at ‑‑ and here\'s where I\'m getting into the
economic dimension. I don\'t know exactly how we build this up or
whether there\'s existing research, but I know in our first meeting Dr.
Foster and Dr. Dresser both raised this question about how we are
allocating resources, who benefits, and if you view our question
globally those questions become very acute indeed.

Enhancement for cosmetic purposes, treatment of the very expensive
diseases of old age, in a world where many people do not live long
enough to either require the former or the latter.

Oh, one other thing is I do think somewhere in our report we ought to
have some information about what Dr. Foster raised in our first meeting.
Who benefits from the various technologies? Who is investing in them?
Just a picture of the whole economic background would be very helpful.

DR. KASS: Bill May, Janet, Charles.

DR. MAY: Before the era of pharmacological interventions, the topic of
enhancement came up in the thought of that cheerful optimistic Norman
Vincent Peale and the power of positive thinking. And a friend of mine
wondered what it would be like to see a pole-vaulting contest with two
positive thinkers on opposite sides competing with one another. You
could never bring the meet to an end.

One thing that doesn\'t receive as much emphasis but that is there on
the margins is the whole question of enhancement in the form of
life-extending technologies. I think one faces a very difficult issue
when it comes to the issue of the choice of means to knock out
adventitious disease and death on the one hand, and the use of some
means towards the end of life-extending technologies, to move towards
110, 120, 140 years.

And one may have one view on the question of cloning for biomedical
research if one is talking about adventitious disease and death, but
quite another view if you\'re talking about the organization of
resources and the mobilization of nascent human life towards the end of
life-extending technologies. And it is this dimension of the problem of
enhancement that I think has to be part of the discussion.

DR. KASS: You mean changing the maximum life span is ‑‑

DR. MAY: That\'s right.

DR. KASS: Yes.

DR. MAY: That\'s right.

DR. KASS: Janet, please.

DR. ROWLEY: Well, I think we should really take a rather cautious view
of how we extend our discussions in this area. It\'s true that many
individuals, particularly those with resources, can already take
advantage of whatever they feel science or other modalities have to
enhance aspects of their life. And I think that this is really a matter
for individuals to solve for themselves.

I notice that the examples that are included in working paper 7 ‑‑ none
of them involve embryos. So they\'re all, at least as far as I could see
when I read them ‑‑

DR. KASS: Deliberately.

DR. ROWLEY: Okay. So this is ‑‑ that\'s fine.

DR. KASS: Yes.

DR. ROWLEY: But then if one is ‑‑ because it seems to me that the major
concern or a major concern that has been expressed is how we will be
able to manipulate DNA such that we will enhance the zygote to develop
into a smarter, stronger, to quote Paul, faster human being.

And it\'s in that area ‑‑ and I think I mentioned this in the first
meeting ‑‑ all of these traits involve anywhere from 50 to 100 to 200
individual genes working together in a highly regulated, concerted
fashion to lead to somebody who is very smart or very tall, or whatever.

We don\'t have a clue about that. We probably are not going to have a
clue about those interactions, both positive and negative, for another
10 or 20 years. So I think that enhancement, in terms of somebody ‑‑ for
reproductive cloning is so far down the line that, again, that\'s not an
issue that we need to take up.

DR. KASS: Let me say there has been talk about our report. This is not
‑‑ this discussion about enhancement is not for the cloning project. I
mean, this is question ‑‑ one of the nice things about this question is
that it\'s not tied to any particular technique, but it is a kind of
question that cuts across the board and enables us to ask, how do we
begin to think about the uses of powers that go beyond therapy, however
broadly we finally decide we should define therapy? What norms and
standards should guide us?

And I think Janet\'s point is very well taken. My own suspicion is that
this fine-tuning of the higher human powers through genetic intervention
is mostly talk, and certainly talk for a long time. But pharmacological
things, things based upon coming trends in neural science, or the use of
‑‑ and the Olympic Committee is already quite concerned about blood
doping the muscle mass of mice.

Using just injection of ‑‑ using DNA vectors to ‑‑ in mice has increased
their muscle mass some threefold. And the Olympic Committee is already
very concerned about the uses of EPO to change performance ‑‑ in effect,
the whole character of the Olympics.

So I think we should ‑‑ if we are going to take this up, if we take it
up, we should be very careful to use examples that are here, plausible,
and not simply leap to the things that are far-fetched. I think that\'s
a caution very, very well taken.

I have Charles, Gil, and Elizabeth. Was it on this point, Elizabeth?
Because I don\'t ‑‑

PROF. BLACKBURN: A very small point.

DR. KASS: Please.

PROF. BLACKBURN: You said DNA vectors. And I thought since we are in a
large group of people with different backgrounds we should just define
that. It does not mean introducing DNA into the cells or the genome of
people, but simply the DNA is used to make the product that you are
talking about.

DR. KASS: Yes.

PROF. BLACKBURN: I\'m not sure if that was clear to everybody. I thought
that it was worth clarifying that technical terminology.

DR. KASS: Thank you. I lost my place. Charles and then Gil, Michael
Sandel, and Dan.

DR. KRAUTHAMMER: It was deeply refreshing to go a half hour without
hearing the word \"embryo.\"

(Laughter.)

But that\'s over now.

(Laughter.)

I agree with you that we ought to concentrate on the here and now, and
that means one-shot enhancement versus germ line enhancement. But I\'m
not sure that one-shot enhancement ‑‑ I mean, the kinds of things that
Dr. McHugh was talking about, are that much unrelated to the age-old
enhancement of alcohol.

I mean, we have a paradigm for dealing with enhancement. It\'s not
exactly a new problem. It\'s got new dimensions. I think what is new is
the prospect it could be a decade or two or more away of ‑‑ germ line
enhancement ‑‑ of changing us permanently. And as a Commission with a
wide mandate, I\'d like ‑‑ I\'d hope that we could discuss that also. We
probably would be the first to think about it officially. We might
contribute to people\'s thinking about it when it becomes more imminent.

And one of the reasons it\'s important, as Professor Glendon mentioned,
there is a question of economics. There\'s a deep question of, as
opposed to international inequality, of national inequality. If we are
going to have permanent enhancements of a similar kind to germ line
enhancements, it is overwhelmingly likely that it\'ll be the rich and
that those well-positioned who will have access, and what that does is
it changes a society with shifting inequalities to a society of
permanent inequalities.

And that I think is a deep social issue which will really challenge us
in the future. And even though it is in the future, I think it\'s worth
us thinking about now as a way to contribute to people thinking about it
when it actually becomes imminent.

DR. KASS: Thanks, Charles.

Gil Meilaender?

PROF. MEILAENDER: Yes. I just wanted to think a little bit about where
Paul started us, because I really do think if we\'re going to try to say
anything about this, or even just talk about it, it\'s very puzzling.

If we start at the furthermost reaches of Paul\'s set of possibilities
‑‑ I mean, people don\'t just want to ‑‑ they don\'t just say they want
to be taller, stronger, brighter. I want to be those things because I\'m
not happy right now. You know? I\'m just not happy with my place in the
world. Or maybe if I have taken a philosophy course, I\'m feeling
alienated even.

So the ‑‑ if we\'re not able to make some kind of therapy enhancement
distinction, we\'re not going to know or we\'re not going to have any
sense of kind of what it would be appropriate for a doctor to decline to
do, what it would be appropriate to think that somebody ‑‑ some third
party should fund, what it would be appropriate to regulate or not
regulate.

And, I mean, Paul presented a series of steps, but I don\'t think
there\'s any reason to think that what I counted as number 6 in it, you
know, has thus far been demonstrated to be enhancement as opposed to
therapy.

Now, I think it is, in fact, but one needs an argument more clearly
spelled out. And even going farther up, you know, the emotional
reactions to life stresses, well, there are a lot of religious thinkers
who think that life is always stressful, and that it\'s not actually
wrong to feel alienated in the universe. After all, one needs a certain
kind of answers to those questions.

That\'s not necessarily a medical problem. That might be really keen
insight into the nature of things.

So this is just ‑‑ I mean, this is not to provide an answer but to say
that I don\'t think there is any progress to be made in thinking about
the question if somehow or other we don\'t really clarify that issue,
not just talk about it but actually try to clarify for ourselves what it
is.

DR. KASS: Could I ‑‑ no, let me hold back. We\'ll come back to it.
Let\'s go in queue. Michael Sandel and then Dan, Frank, and Rebecca.
That\'s what I have.

PROF. SANDEL: I do think we should take up the topic, and I think we
need to address the questions that Gil and others have raised. We have
to ‑‑ apart from deciding where the line is between legitimate therapy
and enhancement, and in the course of drawing that line, we\'ll have to
press ourselves, demand of ourselves, that we try to articulate what
human goods are at stake in drawing a line, whether for moral or
regulatory purposes.

In the case of ‑‑ and I think that we can do that. I suspect ‑‑ and this
is just initial speculation ‑‑ that the objections that we will find
ourselves articulating to enhancement, whether of the one-shot or of the
germ line kind, will have some close kinship with the best reasons to
worry about reproductive cloning, which is that in both cases the
morally troubling feature is a kind of hubris and a picture ‑‑ a world
picture in which we, as human beings, aspire to mastery or sovereignty
or control ‑‑ ultimate control ‑‑ over nature and ourselves such that we
come to be and to see ourselves as self-creating beings who can make
ourselves over according to our desires.

I think that\'s what\'s troubling about reproductive cloning because
it\'s cloning for a child of a certain kind, according to our own design
and ambition. And I think that\'s ultimately the moral part of the
objection to enhancement.

And in order to draw the distinction, even if that\'s the underlying
moral worry, we are going to have to try to work out some account of
what normal human flourishing is, or health, and that might be that
account which isn\'t an easy matter to articulate. That kind of account
would have to provide reasons to restrain the drive to self-mastery and
self-perfection that may underlie ‑‑ may animate the drive to
enhancement and perfection, and that we would want to reign in.

I would also ‑‑ so I think that\'s the fundamental moral issue that
we\'re going to ‑‑ and I think we should try to take it up, and others
may have different ways of accounting for what troubles us about
enhancement. But I would just also want to add support to Mary Ann\'s
proposal that we include in these discussions the economic dimension.

Now, there is a certain paradox in having these two discussions, because
on the one hand we\'re saying these various techniques of enhancement
are deeply dehumanizing properly understood. And then, with another part
of ourselves we say, and, by the way, we also worry that these
dehumanizing technologies will only be available to the rich, and
that\'s unfair.

(Laughter.)

So I think there is that paradox. But I don\'t think the fact that it\'s
paradoxical should lead us to shrink from either part of that
discussion, because I think there is something troubling on both poles
of that paradox.

DR. KRAUTHAMMER: Ice cream is equally dehumanizing, but everybody wants
it.

DR. KASS: Please, Janet, a quick point.

DR. ROWLEY: This is just a quick response to Michael, because one of the
nice things about Paul\'s discussion was that he emphasized that this is
really a continuum of things about which there would be almost no
question to things that we all sort of laugh at and hope that we don\'t
have such a shallow view of ourselves and our place in the universe.

But, you see, Michael continually used the word \"line,\" that there is
a line over which you go. There is no line in my view, and the line is
going to depend ‑‑ for each individual case it will be different and the
circumstances of those cases. So to deal with this discussion as though
there is an absolute answer, which will be applicable across all of
these complex situations, I think is not correct.

DR. KASS: Well, I\'ll sit back.

(Laughter.)

That\'s the trouble with conversation. You really want to continue it,
but there\'s a queue. Dan?

DR. FOSTER: I only want to make one ‑‑ by the way, I agree with the
issues of justice and the other things that have been said, and I
certainly think ‑‑ and I\'ve already told Leon, I think we clearly have
to discuss the issue of germ line therapy.

And, by the way, even when you do somatic gene therapy, it\'s now clear
that there\'s a danger of leak into the gonads. I mean, for the genes
that you put into the muscle, there\'s a clear-cut risk of overflow into
the germ cells. So we have to be careful about that.

I only wanted to say in terms of life enhancement and extension of life
that ‑‑ particularly extension of life that Bill spoke about, we know
pretty well already how one can extend healthy life from Drosophila
through ‑‑ not absolutely proven in humans, but indirectly, and that is
to undereat.

There is no doubt ‑‑ it was first shown in rats by Donald Massoro 25
years ago at the NIH, that if you semi-starve rats that you increase
their lives 20 to 30 ‑‑ now, if you starve a fruit fly, it\'s very
interesting. This was done and people didn\'t understand why the flies
were living for a long time. Not only did they live, but they were
reproductive late into life. They continued to be able to reproduce.

And the key gene involved with that ‑‑ these gene people always give
these cute names to them ‑‑ it\'s called INDY. I\'m Not Dead Yet.
That\'s the INDY gene ‑‑

(Laughter.)

‑‑ in the fly. You know, it\'s just like Tin Man gene in heart
development. The Tin Man had no heart, and if this gene is mutated you
don\'t get a heart, you know, so they ‑‑ so there are things that we can
do without any biotechnology or anything else just by healthy things
that would allow us presumably to live long. We don\'t know whether the
dementia would be impaired or things of that sort.

You have to be careful, because I get challenged about this sometimes.
If you measure the body mass index, which is what everybody uses for
obesity and weight, it\'s just the weight adjusted for height. And a
normal body mass index is 25, and obesity is at 27 in this country, 30
in the world. It\'s a J-shaped curve of excess mortality.

So, in other words, as you go above ‑‑ as you get more and more obese,
then it\'s a logarithmic increase in deaths from everything from colon
cancer to diabetes, and so forth. But it\'s a J-shaped curve, so if
you're BMI is very low, that you have an excess mortality as well. Those
are sick people. Those are people with restricting anorexia nervosa,
where you have sudden death, or cancer, and so forth. So don\'t be
misled by that J-shaped curve. That\'s a pathologic ‑‑ the short curve
on that is pathologic.

So my point is that there are an awful lot of things that we could do ‑‑
we can do to \"enhance life\" by just being healthy, and I just wanted
to make that point.

DR. KASS: Thank you.

Frank, Rebecca.

PROF. FUKUYAMA: I wanted to respond to something that Janet said, and
then to ask Paul a question. I really think that the whole question of
germ line engineering is one that we have to address. I think that ‑‑
and, in fact, the complexity of genetic causation is actually one of the
reasons that we have to address it, because the simple fact that we\'re
not going to understand that complexity in its fullness is I think one
of the reasons that it\'s dangerous.

I don\'t think that\'s going to stop people from, you know, going ahead
and doing experiments on animals in which they modify, you know, one
gene and it produces an effect, and then they will try to, you know,
reproduce that in humans. And I think what\'s really problematic about
that is precisely because that causality is so complex that it\'s not
like approving a new drug ‑‑ you know, the FDA approving a new drug
where you have a certain set of side effects you\'re looking for.

I mean, the side effects of that kind of intervention could be, you
know, things that don\'t show up until the ‑‑ you know, the subject is
60 years old. I mean, they may be very subtle. It may upset all sorts of
different kinds of balance.

So it\'s ‑‑ I think that, you know, inherently there\'s got to be a
different, you know, standard for approving that. But that ‑‑ simply the
fact that it\'s complex is not going to, you know, stop development in
that area. And, therefore, I think it is something we need to look at.

My question for Paul is it really does seem that psychiatry is a really
different domain. And, for example, I don\'t really understand the
process by which things get entered into the DSM as disorders, because
it seems to me that that\'s basically a political negotiation more than
a scientific one.

But I wondered if you could ‑‑ because in other areas of medicine I
think there are things that people pretty much agree are pathologies,
and there\'s good reason ‑‑ there\'s an etiology, and so forth. But in
psychiatry, that\'s not true.

DR. McHUGH: For some psychiatrists it\'s not true. I\'d put it to you
that way. I think DSM‑IV is the ultimate extension of a problem that we
solved ‑‑ we tried to solve 20 years ago, and it\'s now a problem in
itself, demonstrating that the problems of today are due to the
solutions of yesterday.

Let me just make that clear. In the 1970s, psychiatrists couldn\'t do
research, really, because they couldn\'t agree on what was, for example,
schizophrenia. You\'re called schizophrenia in Baltimore; you\'d be
called manic depression or maybe panic anxiety in San Diego.

The DSM process was to try to give us a common nomenclature with the
idea that we would become more reliable. And, therefore, if I said I did
research on schizophrenia and had these results in Baltimore, it would
be replicable in Boston as they were trying to find reliability.

But DSM-IV and DSM-III are really a nomenclature that could as easily be
organized alphabetically as it could any other way. And now we are
really troubled by two things in it. One, that it\'s drifting away from
medicine. We are inventing more and more diseases or disorders in
DSM-IV, such that it\'s expanding exponentially. There are now 2,000
different forms of depression that you could figure out from that book.

And there are also conditions that are invented that are in that book.
You have to just get a group of psychiatrists together, and if they say
something exists they can put it in the book. I\'m surprised ‑‑ you
know, I\'m happily surprised that witches aren\'t in the book. There are
criteria for finding a witch, after all, but we had that trouble before.
So ‑‑

DR. KASS: That\'s not a disorder anymore.

DR. McHUGH: Excuse me?

DR. KASS: I said that\'s not a disorder anymore.

(Laughter.)

DR. McHUGH: That\'s not a disorder anymore, but it\'s operationalized.

DR. KASS: It\'s a lifestyle.

DR. McHUGH: I can show you the book in which they show you this is an
operationalized term. You drop them in the water. If they sink, they\'re
not a witch. If they float, they are.

(Laughter.)

Massachusetts has a lot to answer for.

(Laughter.)

The future right now, in my opinion ‑‑ this is a side issue, but it
relates to what we\'re talking about. Psychiatry has to move in a
direction of more and more valid conditions that relate to certain kinds
of underpinnings that relate to the brain or to other clear human
disorders.

And we have not done that, and I think the next 10 years is going to be
very interesting in the developing of DSM-V. If DSM-V is identical, or
just an extension of DSM-IV, that will be a disaster for this
discipline.

DR. KRAUTHAMMER: Could I add a cul-de-sac on that diversion? I worked on
DSM-III in the \'70s, particularly with Jerry Clerman on the depressive
disorders. And you\'re right, Frank. There\'s a lot of politics in it in
the end. It was ‑‑ as was pointed out; it was a serious attempt to
systematize nosology and to get sort of a reproducible list of symptoms
and signs that would model what happens in the rest of medicine.

But in the end, of course, it\'s politics, unlike ‑‑ I suppose unlike
the criteria for Type 1 diabetes. The criteria for major depression are
negotiable, so you negotiate them; you end up with a consensus.

The one virtue is that you establish a preliminary consensus in DSM-III,
and then you spend a decade seeing if empirically it separates patients
into groups that are therapeutically useful. And that\'s how over time
you eliminate the politics. But as of now, there\'s a lot of politics in
the negotiations.

DR. KASS: Rebecca, Mike Gazzaniga.

PROF. DRESSER: When we talk about decision-making about enhancements or
borderline conditions, I think we should approach it with the
recognition that these decisions will be made at different levels. I
doubt if there are many bans. There might be some. But there will be
decisions on allocation of resources.

And professional standards ‑‑ that is, clinicians saying here is what we
consider to be legitimate practice of our profession, professional
integrity issues ‑‑ and then decisions by people who are seeking these
interventions. And I think the rubber meets the road pretty much on
these final two ‑‑ in these final two areas about ‑‑ and I think it was
in the early \'90s I was trying to help draft a statement on use of
growth hormone for the American Academy of Pediatrics Bioethics
Committee.

And we all agreed that this ‑‑ the reason people don\'t want to be short
is primarily due to social reasons. That is, if it weren\'t a
stigmatized condition, and if cars and kitchens and so forth were
designed to fit people who were short, then this would not be a problem.

On the other hand, the pediatricians say, \"What am I supposed to do
when the parents come in with their short kid? Everybody is miserable.
It looks like the child is going to be short for genetic reasons. How do
I say no to those people? You know, I need help.\"

So the pediatricians need help, and then the people seeking these
technologies ‑‑ I hope that we can help people think better about these
choices, because I think a lot of the demand will come from them. So how
can we help people be more thoughtful, aware of the risks? And, of
course, most of these things will have some risks ‑‑ and also, the
nature of the benefit.

As Gil said, people do these things because they think it will make them
happier. And how valid is that belief? Is there anything we can say
about that belief?

PROF. DRESSER: Mike?

DR. GAZZANIGA: Well, I want to take credit for having paid for two of
Paul\'s two-shot enhancers last night ‑‑

(Laughter.)

‑‑ leading to his eloquent opening remarks that really paint a picture.
I thought I\'d follow up and just get off the germ thing and the clones
and the embryos and talk about some of the other gadgets that are
around, because I think this is one of the concerns that sort of comes
out in the paper, and so forth.

So, in the sphere of high-tech possible aids that are coming down the
pike, now being worked on diligently to ‑‑ for therapy of spinal cord
injury, there are people that are working on devices that can somehow
read the electrophysiological state of the motor cortex and interpret it
through mathematical algorithms that somehow figure out what the motor
cortex is trying to say to the spinal cord, and then to physically jump
over the lesion the person has at whatever level, plug in the electrodes
below the lesion, and by thinking as it were their way through the
movement, energize the neurons below the cut and thereby giving rise to
mobility.

Now that\'s a ‑‑ we\'re nowhere near there, but there are very, very
clever people working hard at this and making advances. Slow, hard
advances, I might add, but it\'s something that\'s in the tube.

Now, what then comes along is other research that shows that maybe there
is some way you can read the desire to figure out what two plus two is
by reading your brainwaves and then access this through some artifact
that you might have on the side of your head that actually solves the
problem for you.

So instead of you struggling with your multiplication tables or your ‑‑
whatever, this device picks up the essential brain circuitries, pattern
of activity, sends it over to this machine, the machine says, oh, he\'s
trying to figure out this problem, the machine figures it out, sends it
back to your brain, and the kid raises his hand right as the button ‑‑ I
got the answer before everybody else in the class.

That, too, is a dream at this point. It\'s talked about, written about,
but no one really quite takes it seriously yet. But you can ‑‑ the way
that could work certainly is in the thought processes of some.

But I think this feeds back immediately to the ‑‑ so there are these
things. There are these whole other area of technological developments
that the world is going to be hearing about in the press way before it
gets solidly built up in the scientific literature.

But, of course, I\'m kind of of the view that there isn\'t a thing that
our human species doesn\'t adapt to once they think about it and absorb
into its evolutionary sequence. And we have these enhancements all over
the place. The kids now take their graphic calculator in to take the SAT
test, and that didn\'t ‑‑ that wasn\'t allowed a few years ago.

So there are environmental enhancers. You can go take the Kaplan test
and pretty much bump your score up a couple hundred points if you work
hard on it. And all of these things ‑‑ and I don\'t think that a
reasonable group of people, certainly those of us involved in higher
education, see those things as relevant, particularly relevant
variables, because what you want to do in science is try to identify the
student that is creative, insightful, sees a problem in a way that
everybody else in the lab doesn\'t see it.

And once they have an insight and then do the experiment, all of this
sort of elevated notion of being higher on an SAT is just part of the
data analysis. And the data analysis is ‑‑ while it seems opaque and
hard to do when you don\'t know anything about it, that\'s the easiest
part of a scientific exchange is coming up with the idea and the insight
on how to proceed is the challenge. And I don\'t think anybody has a
clue about what sort of gene manipulation encourages that kind of thing.
It\'s a rare, rare thing to see.

And, finally, to return to the germ line issue, which is obviously an
important issue, there are many ‑‑ I think the Council would be well
advised to have, as we did yesterday, two leaders of this come in. There
are certain major molecular biologists ‑‑ Eric Lander comes to mind at
MIT, who is totally against any germ line manipulation, and there are
other biologists ‑‑ I can\'t think of one right now, who would be the
best for promoting it.

But there is major thinking going on in the major intellectual centers
on this point, and I think we\'d be well informed to hear about them
before we go too far in thinking about it from an ethical point of view.

DR. KASS: Michael, thank you.

Michael Sandel?

PROF. SANDEL: I wanted to go back to the moral questions associated with
the allocation of resources that Mary Ann raised. And I think this is an
issue whether we\'re in the realm of pharmacological or surgical or
genetic interventions for enhancement.

There are a couple of ways one could imagine dealing with this problem.
One of them struck me when a year or two ago I read an article about a
cure for wrinkles, some kind of wrinkle remover that was produced by a
cosmetics company and extremely successful financially.

And it turned out that the compound used in the wrinkle treatment if
just slightly reformulated was also a cure for sleeping sickness. And
the company agreed to work with a foundation and to make available for
free through its production facilities this slightly reformulated
version of the wrinkle cream which it could produce in massive amounts
because of the huge market for enhancement to cure a disease which was
far more morally significant but which would never have been invested in
had that been the only reason.

When I read about this, I didn\'t know whether to be heartened or
distressed, heartened that it was a creative solution to the problem,
the distress that sleeping sickness and similar morally pressing
diseases are only attended to insofar as they happen to coincide with a
cure for wrinkles, and so that ‑‑ insofar as there are those
opportunities, that would be one way of dealing with the problem.

But I want to go back to the face lifts that Paul raised ‑‑ low-tech
enhancement ‑‑ and to I think ‑‑ the germ line questions force our
attention to existing practices that may be morally questionable. And as
for the face lifts, surgical or through this Botox, it seems to me ‑‑
well, I\'m not sure, Paul, where you put it on your list, but I take it
you don\'t admire it. It\'s not something you find morally admirable ‑‑
the purely cosmetic face lift.

One way we might deal with that ‑‑ and Janet is worried about excessive
regulation. We wouldn\'t need ‑‑ if we found ‑‑ of course, in all these
cases, if we find something morally troubling it\'s a further question
what the law should do or what regulation should do.

But if we agree that face lifts, for example, are not morally admirable,
but yet they don\'t pose such a grave problem that they should be
legally banned, what we might do with them is what we do with alcohol.
We can impose a sin tax. We could consider that face lifts are not a
crime but a sin, and, therefore, they should be subject to a sin tax,
the revenues of which should go toward the health, or the restoring to
health in the case of things like sleeping sickness and malaria that
wouldn\'t otherwise get the resources. That\'s a modest proposal.

DR. McHUGH: Can I just say what I do think about face-lifts?

(Laughter.)

It\'s all in this area of facial cosmetics, which go from treatments
that I think we would be very happy to offer anybody to ones that we
think that vanity is being served. And there is no ‑‑ I don\'t see a
good, clear line, because, again, orthodontia could be put into that,
too.

Lots of people who were poor when they were children and couldn\'t have
orthodontia and are still unhappy about their teeth get it in their
forties and fifties. I had a secretary who, fortunately, got some ‑‑ she
began ‑‑ I would hate to tax her for that, because she was always very
distressed about her teeth.

PROF. SANDEL: Orthodontia is not a sin in the way face lifts are,
insofar as it does have some relation to health, even though, you know,
it may be marginal.

DR. KASS: Elizabeth? Bill?

DR. HURLBUT: I think that one of the things that we have to do is to
realize that we are already in an era of enhancement in a certain sense
in ways that we haven\'t been fully attentive to as they\'ve unfolded.

I mentioned the first day the issue of contraception, and here I don\'t
bring it up to judge it, just to say that it was a kind of alteration of
our natural reality that slipped in along the gradient of apparent human
good, or at least a desire, that went ‑‑ came in fairly unquestioned at
the time, had a significant impact on altering our personal lives and
our social existence, and now we\'re slowly getting a perspective on it.

But this brings me to what I really wanted to mention. That is that at
the foundation of this whole question of enhancement are deeper
philosophical, almost religious questions about, what is nature, and
what kind of a mind has this world produced in the creatures that now
have the power to govern nature?

Einstein said that the most incomprehensible thing about the world is
that it\'s comprehensible. That\'s ‑‑ I think he meant mathematically,
but the question is whether it\'s morally comprehensible in the sense
that we understand ourselves. It\'s clear that we live and will use our
new powers along the gradients of our desires, but within the natural
mind it seems to me that desires function as impulses toward a
direction, not necessarily a destination as such.

So that if desires, like, for example, the desire to eat that Dan was
just speaking of, it may be good for you ultimately to eat less, but in
our environment of evolution and adaptation we developed a strong
tendency to want to eat more. And so now that we have refrigerators we
basically have at our hands more than it\'s good for us to eat. And so
now we have an epidemic of obesity.

So that seems to me to be a fundamental issue. We have to figure out how
we relate to nature, what is good within the order of nature, and it\'s
going to take not just scientific knowledge but a kind of self-knowledge
of what\'s driving the force that would produce the gradients along
which we would move toward our enhancements.

Does that make sense?

DR. KASS: Yes. Thank you.

Elizabeth, did you want to ‑‑ nothing? Bill May, and then I\'d like to
put myself on the list.

DR. MAY: As I recall, Alasdair MacIntyre a number of years ago wrote a
piece responding to Joe Fletcher\'s essay on the markers of humanhood,
which Joe Fletcher had justified designing improvements in human
beings\' intelligence and the rest.

And MacIntyre puzzled on the question of what kind of humanity you would
like to see in future people, and he ultimately decided that the kind of
humanity you\'d like to see there would be precisely those dispositions
that would lead them to renounce the hubris, the arrogance of designing
irreversibly their descendants. A very interesting, ironic piece.

I suppose germ line enhancements would give future generations one more
reason to resent the overreaching of their parents ‑‑ their designer
parents ‑‑ unless one could build into the enhancement the disposition
to gratitude.

(Laughter.)

DR. KASS: Let me make a couple of comments and then try to maybe get a
little more focus into the way in which we are proceeding. I think ‑‑
just a number of observations I guess, not altogether coherent.

First of all, I think we all recognize that there is continuity here
with no lines, which makes this very difficult. The people who trot into
this discussion by saying enhancement versus therapy haven\'t thought
enough about it, because the area ‑‑ nevertheless, that there is a
twilight doesn\'t mean that at a certain point you know that it\'s day
and at a certain point that you know that it\'s night.

And it\'s incumbent upon us if we think that there is some distinction
here, however fuzzy the boundary is, that\'s worth making ‑‑ it seems to
me it\'s worth struggling to try to clarify what it is that is at stake
and what it is that ‑‑ how we might evaluate it. That would be point
number one.

And I think this point has been made by others, but the fact that there
is already precedent ‑‑ that was in a way the part ‑‑ the force of
Michael Sandel\'s question to you, Paul. The fact that certain sorts of
things are already accepted, and, therefore, might serve as precedent
for the next step cuts in two directions.

We might reevaluate where it is we have gone and see it only in the
light of hindsight. And the fact that there are environmental kinds of
enhancements may or may not be precedent-setting for what to think about
enhancements written into the human body or mind, whether reversible or
not.

I\'m not begging the question. I\'m simply raising it. We came to this
before when one wondered about, what\'s the difference between
bioengineering and social engineering? And does it have a kind of
different moral character for us to consider?

Third comment ‑‑ and that has to do with I think it\'s very ‑‑ it has to
do with the business about inequality and justice. And my response to
Michael\'s very astute observation is to say it\'s very easy I think for
us to treat this question in terms of the distributive justice question
and to also recognize what a precious ‑‑ what preciousness there is to
be sitting talking about these sorts of things when there are really
much more profound human concerns and questions about the uses of our
resources, and so on.

But I think we would do ourselves a disservice if we immediately said,
look, the real problem here is that some will have and some will not. I
think the first question is whether the thing which is sought for is, in
fact, desirable because there will be a great deal of pressure to have
what this is, if, in fact, it turns out to be good. And all you\'d have
to do would be to take a look at the example of the Ritalin use for
improved test results.

Let\'s assume for the moment that there is something like this which
actually improves attention span and people get wind of it. The
pressure, even on the people who have no interest in using it, is
comparable to the pressure that is now available to extra tutoring and
extra ‑‑ those sorts of things.

So that even if it ‑‑ we don\'t ‑‑ even if we leave these matters to
free, private choice, the social pressure in the direction of using
these various kinds of enhancements, at least in this community, would
be considerable. So I think it\'s rather important for us to try to look
‑‑ to not start with the question of inequality or distribution, but to
look at the question of the enhancement itself, or the alleged
enhancement itself, and see what one thinks about it and what its human
costs might be, assuming that the blessings of it could flow to
everybody. Okay?

Now, maybe we could make some progress on this if we took one of the
examples here that\'s been put before us by the staff for discussion.
And I don\'t know which of them would be most fruitful, but ‑‑

PROF. FUKUYAMA: Leon?

DR. KASS: Please.

PROF. FUKUYAMA: I have a suggestion.

DR. KASS: Oh, please, Frank.

PROF. FUKUYAMA: I mean, this ‑‑ I mean, I actually was going to talk
about the Ritalin example, which I think would serve your purpose as an
illustration of ‑‑

DR. KASS: Well, let\'s do that. Do you want to start off?

PROF. FUKUYAMA: Yes. Well, I mean, this in a way anticipates what I was
going to say when we started talking about regulation in the next
session. But you already have a case with the drug Ritalin where you
basically have a distinction made between therapeutic and enhancement
uses.

And, actually, the point I was going to make when I put myself on the
queue was that I think that actually it is easier to make that
distinction in practice by a regulatory agency than it is to make it
theoretically sitting around a table, you know, with very wise people
like this, because, in fact, you know, there is no ‑‑ well, if you take
something like Ritalin, it\'s used to treat this condition ADHD, which
it seems to me is a classic case of a socially constructed disease.

I mean, it\'s not actually a disease, but it\'s simply the tail of a,
you know, distribution of normal behaviors. And when you get far enough
out into the tail, you know, by these very subjective diagnostic
criteria that are now in the DSM, you say, okay, this kid has ADHD, and
then you can ‑‑ a doctor can prescribe Ritalin.

And I think using your example about the twilight, you know, there is no
‑‑ people wouldn\'t have any question about its appropriateness for
people way out in the tail. And I think they would also have a lot of
question about pure enhancement use when you\'re simply, you know,
cramming for an SAT, and, you know, have no problem with attention
normally.

But you\'ve got this big area, you know, in the middle where I think
most of the controversy lies about, you know, whether it\'s being
over-prescribed. And so you can\'t imagine a drug or a condition that is
more subject to this fuzzy boundary between therapy and enhancement, and
yet we regulate it, and I think we regulate it, you know, not terribly
unsuccessfully.

The DEA prescribes it. It\'s a Schedule II drug, which means that it is
controlled by the DEA as a controlled substance because it is an
amphetamine, and it is prohibited as illegal to use it for, you know,
pure enhancement uses. But it can be prescribed for therapeutic uses by
a physician.

And, you know, you can\'t justify theoretically, you know, why the
cutoff line is where these particular regulatory agencies say it is. And
then there\'s obviously a lot of argument back and forth. And yet in
practice, you know, we are able to maintain that kind of a distinction.
And I would say that in a lot of other areas, as a practical matter, we
will be able to do that.

In all regulation, no regulator can really ever justify the line that
they make. I mean, they say, you know, eight parts per million rather
than 11 parts per million. Well, why? I mean, you know, in fact it could
be moved up or down. But, you know, regulation is a political process in
which you get various interested parties that push and shove. And if the
institution is designed properly, you can actually come up with a kind
of social compromise that is not theoretically justifiable, but, in
fact, you know, draws that distinction.

And I think that, you know, as a matter of, you know ‑‑ I mean, there
will be plenty of these fuzzy areas, but I think we already have
precedent for society drawing distinctions between, you know,
therapeutic and enhancement uses of, you know, psychotropic drugs. And
so I don\'t see why that won\'t be possible to do in the case of, you
know, upcoming technologies as well.

DR. KASS: Well, what\'s your confidence in this? No, I mean, because, I
mean, so far the pressures for pushing the boundary have been relatively
slight. I mean, well, put it ‑‑ I guess your question could be followed
up in a number of different ways.

Is the implication of this that the philosophical question of where the
boundary is, or is it good or bad, is not worth our trouble because the
prudent people will somehow intuitively know where it is and take care
of it if we give them the proper regulatory mechanism?

Or that the medical profession, which is in charge of prescribing,
already has sort of sufficient internalized norms of what is the proper
professional use and that they won\'t give out feel-good pills or, in
the elite places, actually administer Ritalin on the side for testing
purposes. What follows from this?

PROF. FUKUYAMA: Well, what I draw from this is that you see ‑‑ you hear
a lot of discussions, like the one we\'ve had this morning, in which
people quite rightly say, oh, it\'s very hard to draw a distinction
between therapy and enhancement and give lots of examples why that\'s
the case. And the conclusion they draw from that is, therefore, let\'s
not even try to, you know, make that boundary as a practical matter.

And all I\'m saying is I don\'t ‑‑ I mean, I\'m sure there are a lot of
cases where it\'s going to be very difficult to draw that boundary as a
practical issue. But we shouldn\'t give up on trying to design
institutions that can maintain that distinction on the basis of a
theoretical puzzlement about, you know, where that boundary, you know,
precisely can be drawn.

DR. KASS: Jim, to this?

PROF. WILSON: Yes.

DR. KASS: Please.

PROF. WILSON: I very much agree with Frank\'s view. My sense of
regulation is that you don\'t regulate until you have a concrete
problem. Regulation in advance, creating entities designed to solve
large problems, is creating great mischief in the country.

We created the Interstate Commerce Commission allegedly to regulate the
flow of goods across the states ‑‑ an ambitious title. It worked
reasonably well with respect to railroads, and, in particular, it worked
reasonably well in getting railroads that took people for short
distances, not to charge them more money than other railroads that took
people for longer distances. This is a way of ending cartelization and
short haul railroads.

But then, lo and behold, trucking came along. Instead of thinking of
trucking as a problem, we gave it to the ICC, which made a terrible mess
of it. The Federal Communications Commission was started to deal with
the problem of radio, but then television came along, and then cable
television came along. And the FCC made a mess of handling these other
things.

The lesson I draw as a narrow gauge, unphilosophical, political
scientist is that society, at least in this country, operates best when
it has a concrete problem to worry about.

Now, the Ritalin example that Frank gave I think is a pretty good
example. Ritalin comes into use, and after some pulling and hauling,
people decide there\'s some good uses and some bad uses. And they create
a kind of regulatory regime around it, which allows mistakes to be made
‑‑ this will always happen ‑‑ but by and large probably tries to
allocate it in the right way.

But much of what we\'ve talked about this morning, these distant, remote
‑‑ as Janet Rowley put it out ‑‑ possibilities for doing X, Y, and Z, I
don\'t think we can draw any political or regulatory implications from
these statements at all.

DR. KASS: Well, could we separate ‑‑ since the regulatory question comes
after the break, could we bracket that for the moment and stay ‑‑ I
mean, stay either with the Ritalin example ‑‑ and, Gil, do you want to
go back to Frank\'s comment or ‑‑ please.

PROF. MEILAENDER: If that\'s okay.

DR. KASS: Please.

PROF. MEILAENDER: Just, I mean, I think it ‑‑ I think you\'re right,
Frank, that there is a sense in which almost any line drawn is often, in
a certain sense, arbitrary ‑‑ at least in the sense that it could
reasonably be drawn at some other places, and so forth.

But I\'d be sorry to think that meant that the theoretical discussion
was unnecessary. I mean, partly just I\'d like to keep drawing my
salary. But we want to know why somebody should be drawing a line on
this matter in the first place. Don\'t we? Even granting that there is
going to be a slightly haphazard quality to where the line comes down,
and that one could argue for different places.

But we want to know why we shouldn\'t just do as we please in this
matter. And in order to answer that question, it seems to me we are
going to have to ‑‑ we\'re going to have to think about the theoretical
question. I mean, so it seems to me it\'s possible to agree in some
considerable measure with your point, but not think that that means that
the theoretical discussion is, so to speak, beside the point or
unnecessary. I mean, both aspects are going to be necessary.

DR. KASS: Yes. Good. Let me try you, Frank. And why ‑‑ let\'s take the
Ritalin example and leave the regulatory question alone, but just try to
think it through. Why should we not allow people freely or ‑‑ that makes
it into a legal question. What\'s morally questionable, or why should we
have any doubts about allowing people to use Ritalin for
attention-improving ‑‑ just for increased attention span, never mind for
tests? Why shouldn\'t they simply be allowed to use it for
non-therapeutic ends? But ‑‑ because it makes them more alert.

PROF. FUKUYAMA: Well, now I ‑‑ you know, by my previous intervention, I
didn\'t mean to cut off the philosophical discussion, because I think I
absolutely agree it\'s very important. So I\'m glad you\'re drawing us
back to that.

I mean, in my view, what\'s problematic about the enhancement use of
Ritalin is that it, you know, challenges certain moral ideas we have
about personality and about character, which is that, you know, we
learn, for example, attention and focus and putting certain things above
certain other things as a result of a, you know, process of education
and socialization that allows us to, you know, over time do things ‑‑
you know, shape our characters in ways that we\'re potentially there at
birth, but ‑‑ you know, but required a certain kind of moral education.

And, you know, the Ritalin in many cases seems to be a convenient
shortcut or a medical shortcut around that that may produce, you know,
something like the effect, but doesn\'t have the ‑‑ you know, the same
effect on character. And, you know, I think it challenges, in a certain
way, our traditional understanding of character.

Now, that then begs the, you know, prior question of, why is that
traditional understanding of character, you know, something that we want
to protect? And, you know, I think that\'s a worthwhile discussion as
well.

DR. KASS: Please.

PROF. WILSON: Frank, how would you distinguish the use of Ritalin for
enhancing one\'s attentiveness from using a pocket calculator? I mean,
was there a moral significance attached to memorizing the multiplication
tables which has now been set aside, or what\'s the difference here
between memorizing the multiplication tables or being more attentive
during a test? This is a genuine question.

PROF. FUKUYAMA: Yes. No, I ‑‑ because I think that moral character
traditionally had to do with the learning of certain internal habits
that, you know, related to, you know, basically being able to, you know,
put long-term goals ahead of short-term goals, you know, being able to
defer immediate gratifications, you know, for the sake of longer-term
things, being able to try to, you know, concentrate one\'s energies on
certain things, and that these are, you know, kind of permanently
valuable traits if ‑‑ you know, if they in fact become habits, you know,
that an individual has.

Now, I suppose you could say knowing the multiplication tables and not
having to use a calculator is ‑‑ you know, is a handy thing, but I do
think that somehow that internal shaping of character, you know, is more
essential to our understanding of what, you know, human goods, you know,
just in themselves are than, you know, being able to calculate things in
your head.

DR. KASS: Mike?

DR. GAZZANIGA: Okay. Let\'s do a case history here. Leon is chair of
this panel. It\'s beginning to get to him. He\'s working the midnight
oil to 2:00. He\'s up at 6:00. The White House is calling him. He\'s got
this panel that\'s not agreeing with him. He\'s working like crazy to
make it all work. This goes on for months.

DR. KASS: You could fix that, you know?

(Laughter.)

DR. GAZZANIGA: It goes on for months, and he finally calls up Paul and
he says, \"Paul, I\'ve got this problem.\"

(Laughter.)

\"Around 2:00 to 4:00, 5:00, every afternoon, I have lassitude. I just,
you know, I just can\'t concentrate.\" And Paul says, \"You know, I can
fix that. I can fix that. We\'ll just pop a little Ritalin in there, and
you\'ll just get through 2:00 to 5:00, and you will be ‑‑ continue your
high level of productivity for these highly moral questions you\'re
working on.\"

(Laughter.)

Would you take it?

DR. KASS: I\'ve been to see him.

(Laughter.)

DR. McHUGH: I wouldn\'t prescribe it, but how many ‑‑

DR. KASS: I went to somebody else.

DR. McHUGH: Excuse me, Mike?

DR. GAZZANIGA: What\'s your take on how many physicians would say,
\"Fine, take a little Ritalin\"?

DR. McHUGH: Well, it\'s turning out over time that there are some
physicians ‑‑ you can find physicians to do almost anything, obviously.
And so some might well do that and, by the way, then get Leon addicted
to an amphetamine-like drug, and ultimately get him quite sick.

DR. KASS: See, we have to clean this up. Let\'s not make it easy for
ourselves by introducing the problem of addiction. Okay? Now, it might
very well be that any of these drugs that are powerful enough to make
the kinds of changes that we\'re talking about ‑‑ I mean, any prudent
person will say anything that\'s powerful enough to make that kind of a
change is a dangerous drug. If it\'s going to mess with your brain, be
careful.

But let\'s not make it easy for ourself by talking about the secondary
consequences either of addiction, or it\'s bad for my liver, or
something like that. But to get, really, to the direct point of what the
difficulty with this is.

And I think ‑‑ let me try it. I\'m not sure I can do this very well,
although the draft that the staff prepared has something about this.
I\'m not sure I would put it in terms of moral character as much as I
would try to put it in terms of what the issue is. I\'m not ‑‑ not the
final judgment. But the question has something to do with the deep
structure of what it means to be humanly active.

I think one could affect the outcome of certain kinds of performances
and achievements, but they might be less the achievements of the person
that ‑‑ and this is not so much a moral claim that effort is good for
you, though I would be willing to make that separately. But it\'s a
different activity if it is not somehow the activity of the embodied and
soul delighted human being trying to be at work and doing the work, if
you somehow detach the end result from the agent.

So that I can see how you might get different achievements but they ‑‑
it\'s not so clear that they would be the achievement of the agent.
There\'s a certain line I think in the staff presentation where if you
doped up several athletes ‑‑ and this is not just a competition point,
but what you\'d really be praising would be the chemists rather than the
agents. And I know what\'s coming next, because we\'re just bags of
chemicals and it\'s very complicated.

But I think what one is most concerned here about is not just the unfair
advantage that some might have over others, but the tendency to
dissociate and disaggregate the deep structure of human activity, the
changing ‑‑ the relation between effort and activity, the changing of
the relation between satisfaction and the activity that produces the
satisfaction, and the preoccupation with the deed and the achievement
separate from its being the achievement of the human agent at work.
It\'s ‑‑

DR. GAZZANIGA: Wait a minute. Come on, that\'s a little too heavy.
We\'re talking about just having you awake.

DR. KASS: No, no. I understand.

(Laughter.)

No, I understand. And I think you\'ve put it very nicely, because it
seems to me that some of these kinds of things ‑‑ that would be a
perfect one ‑‑ would be not so much an intervention that would produce a
certain result, but would be an intervention that might make me much
more fit to be who I am alertly. Right?

DR. KRAUTHAMMER: But what ‑‑

DR. KASS: I\'d just ‑‑ I mean, to be is to be awake. And if I am
flagging, then all kinds of human possibilities are imperiled.

DR. KRAUTHAMMER: But what if his problem is not wakedness but he wants
distraction and a bit of a buzz? Isn\'t this the same question as, why
do we not allow people to take marijuana if they want to achieve
\"happiness\" that way? I mean, we have decided as a society that\'s not
a good idea. Is that that different a question?

PROF. BLACKBURN: I\'d just extend it the other way. Caffeine and coffee
‑‑ we all, you know, very frequently use it. And I think that\'s a very
interesting example because it has parallels with Ritalin because it,
you know, really does have a pharmacological effect, and it\'s sort of
on the other side.

I think we have the difficulty of a continuum of things to think about,
and Ritalin seems a little more extreme, because, of course, there is a
risk of addiction, and we know there\'s a risk of caffeine addiction.
But I think apart from road rage nothing has been attributed to ‑‑ you
know, there aren\'t really bad social effects necessarily from ‑‑

PROF. GEORGE: Leon, just on this point? Or is it ‑‑ it\'s Robby.

DR. KASS: Robby. Sorry, Robby.

PROF. GEORGE: Elizabeth, the parallel with Ritalin in one respect may be
even more exact than you think. A few years ago there was some study
done that was reported in one of the magazines that comes with so many
newspapers ‑‑ I think it might have been Parade magazine ‑‑ that seemed
to indicate that coffee and caffeine before taking SAT tests improved
measurably students\' performance on tests.

Well, you can imagine what the result of this was. Kids who never drank
coffee were given a cup of coffee before going in to the exam. And, of
course, since the Lord works in not so mysterious ways sometimes his
wonders to perform, the kids all had stomach pain and didn\'t do so well
on ‑‑

(Laughter.)

PROF. BLACKBURN: It\'s the sin tax, right?

DR. KASS: Gil? Frank?

PROF. MEILAENDER: Yes. This is relating to this discussion, but it comes
back to a point that Rebecca had raised earlier. She said, you know, we
need to think about what the benefit really is, and so forth.

And, I mean, we don\'t want to sound like sort of a moral nanny in some
ways, but ‑‑

PROF. SANDEL: It\'s a little late in the day to be making ‑‑

(Laughter.)

‑‑ that disclaimer, isn\'t it?

PROF. MEILAENDER: Well, I was making it on your behalf.

(Laughter.)

Sorry. But ‑‑ and this is by no means a full solution to the problem. I
don\'t mean it in that way at all. I mean, I don\'t think it gets us off
the hook for thinking about the therapy enhancement distinction or
anything like that.

But if you think about the thing that Michael raised, we would have far
less to fear from these matters if we were better people. And, I mean,
there should be some way to say that without just sounding moralistic.
In other words, if you\'re going to bed at 2:00 and getting up at 6:00
because you think the bioethical future of the country rests on what you
do, well, then, let\'s think about that and a virtue like humility, for
instance.

(Laughter.)

If you fear for the future if this Council doesn\'t accomplish some of
the good ‑‑ well, let\'s think about virtues like hope or courage, you
know. And as I said, I don\'t know how to ‑‑

DR. KASS: Do they come in a bottle?

(Laughter.)

PROF. MEILAENDER: Well, no, they don\'t, in fact. And we would have less
to fear about these questions, or even about Paul, on one particular
occasion, maybe giving you ‑‑ prescribing the Ritalin if we were better
people in a way. Now, that doesn\'t solve the problem. We\'re not going
to become better people just all of a sudden.

But I think in some way it wouldn\'t be a complete thinking through of
the issue if we didn\'t take account of that.

DR. KASS: Would someone like to join that?

DR. McHUGH: I\'d like to join that and agree with it.

DR. KASS: Please.

DR. McHUGH: And point out that what Michael has described is what
happens quite frequently now in my office. I have a lot of people coming
in and telling me what I should prescribe to them. They\'ve picked it up
on the newspaper or on the ads, and I\'m always throwing it back onto
the very things that Gil is talking about.

The similar thing was raised by Rebecca when she says you bring kids in.
At least three times a year I have very distinguished people bring their
what I consider wonderful young son in. They\'re all Phi Beta Kappa,
Harvard graduates, and the like, and the kid\'s IQ is 110. You know,
he\'s reverted towards the mean.

And the fact is that he\'s six foot tall, he can hit ‑‑ you know, all
net from the center of the basketball field, handsome as the devil, but
they are so sorry that he\'s not valedictorian or things of that. And my
job is to give them hope by telling them ‑‑

(Laughter.)

‑‑ what a wonderful kid this is. Okay? So that very often I avoid this
process of offering medication by talking to people about the meaning of
what they\'re doing, how they are doing it, offering them alternative
ways of looking at what they\'re doing, and some of them are pleased.

(Laughter.)

I emphasize some because ‑‑

(Laughter.)

‑‑ there are quite a few who go and find another doctor to do exactly
what they want done.

DR. KASS: Bill?

DR. HURLBUT: So, Gil, do I understand you saying that what makes an
enhancement legitimate is the sort of final goal toward which it is set
within the larger picture of what human existence is for? What I\'m
thinking of here is beta blockers, for example, are ‑‑ they calm your
hands, okay? And people use them for a wide variety of things.

I went to a guitar concert once and then found out that the guitarist
was using beta blockers. And, you know, half the fun of going to a
concert is to see if they can do it in front of an audience.

On the other hand, if my child were in for eye surgery, I wouldn\'t mind
if the surgeon used beta blockers. So it seems to me that behind this
whole thing ‑‑ that\'s why I said this thing about desire earlier.
Desire is ‑‑ Leon wrote, \"Desire, not DNA, is the deepest principle of
life.\" But if that\'s true, then our desires have to be ‑‑ form a very
coherent cosmology that it\'s ‑‑ is it once in the service of our
individual life and the benefits of our collective lives?

Because so much of what drives the human psyche underneath is ‑‑ I
don\'t know what Mike thinks about theories of unconsciousness, and so
forth, but I ‑‑ there\'s an awful lot of discussion now in neuroscience
and related cognitive psychology that a lot of what we desire is driven
by things under the surface that nature has put the surface goal into
our mind, but behind it connected a lot of things.

That\'s why I brought the issue of contraception, because there\'s an
example where we feel a desire for one thing but nature brings along a
second thing with it. Well, it\'s just an example. I don\'t want to use
it for anything more than that right now, but the point is that that\'s
a major disconnect in human history ‑‑ to disconnect a desire from its
natural end.

And so somehow we need ‑‑ I think behind this whole question is a deep
question of nature, a deep question of the degree to which we know what
is good in nature, and how much we dare to intervene to promote what we
think on the surface is what our lives are about and perhaps then miss
the thing that they\'re really about.

I said the first day ‑‑ I promise this is the last time I\'ll say this,
Leon ‑‑ but I think we could put ourselves in danger of walking
ourselves right off the stage of the drama of our deepest significance.

DR. KASS: Let me make a suggestion. I don\'t know that I can digest this
conversation either now. Fortunately, we\'ll have a transcript. And if
we are more efficient this time than we\'ve been in the past, which
means if the people at HHS actually will post what we give them, within
a week or so we will have a transcript so people can revisit some of
these things and think more about it.

I take it that there is encouragement here for at least exploring this
topic down the road. There are risks in how we formulate it. We have to
pick our topics ‑‑ the subtopics carefully. Let me say for myself, I\'m
not sure that the language of enhancement versus therapy is the optimum
way to do this.

It might be better to leave that language alone and to ask ourselves,
really, the question of, what, if any, are the boundaries between the
admirable and the less admirable users of these powers without having to
tie it into some definitional thing of what you mean by an enhancement
or not.

And part of what\'s at stake there I think is ‑‑ and I\'m not sure that
‑‑ Bill, that this would be a way that you would ‑‑ a reformulation of
the point you\'re making. That would be friendly.

But it does seem to me that thinking about the question of better and
worse uses or admirable or less admirable uses or unadmirable uses or
degrading uses is some kind of notion explicit ‑‑ tacit if not explicit
‑‑ of what it would mean actually to conduce to human flourishing and
our fulfillment, which is not a simple matter and it\'s not for
governmental commissions to settle. But at least we can be mindful of
the fact that some tacit answer to that question is somehow implied in
how one thinks through what norms are we to use when we\'re not engaged
in the business of healing or assisting.

So let ‑‑ Michael, please.

PROF. SANDEL: Could I just add, along these lines, as I\'ve heard this
discussion, I think that however we came at it there is real enthusiasm
for exploring the human and the moral implications of enhancements or of
‑‑ or going beyond aiming at perfection.

And if I could just add a small correction. Before when you chastised
those of us who raised the moral questions of allocation for putting
that ahead of the underlying moral questions of enhancement, I didn\'t
hear any of that. I didn\'t hear any suggestion that that should somehow
substitute or preempt a discussion of the human consequences and the
moral consequences of aiming at perfection. I thought that had been
emphasized by everyone who spoke, and I hope that we take that up.

DR. KASS: Yes. Thank you. It wasn\'t a chastisement. If it came across
that way, I didn\'t ‑‑ it wasn\'t meant that way. But thank you.

Charles, do you want a word? And then we should stop.

DR. KRAUTHAMMER: Yes. Just one word and a caution. I think as we think
about this it\'s important for us to understand how our discussion will
differ from the decades-long debate that the country has had on
recreational drugs, which is a sort of paradigm I think of this
question. So what are we contributing?

I mean, obviously, we\'ll be looking at other aspects of this. But
fundamentally, I am yet to see how our debate about enhancement and all
the issues that we have raised differ from the debate that people have
about whether or not people ought to be able to use stuff that makes
them feel better, and whether that should be legal or not.

It\'s an old debate. I\'m not sure what\'s new.

DR. KASS: Well, let me say a quick word on this. I mean, it ‑‑ the
temptation is to go either into euphorian drugs or cosmetic surgery, and
things of that sort, which are ‑‑ one could have one\'s opinions about
it, but I take it there are serious people seriously thinking not about
just having ‑‑ letting people have their jollies, but actually doing
things that might improve what we are constitutionally, whether it be
through computer implants or neuropharmacological interventions, that
would actually not just do things that would make us feel better but
that might actually transfer in some structural way what we\'re capable
of.

DR. KRAUTHAMMER: Well, that\'s precisely where I think we ought to
focus, because otherwise we would be recreating an old debate.

DR. KASS: Yes. But that ‑‑

DR. KRAUTHAMMER: It should precisely be about changing human capacities.

PROF. SANDEL: Well, the other difference is the next generation.

DR. KRAUTHAMMER: Right. In germ line, which I was advocating that we
emphasize. But since other people have been arguing that it\'s too long,
good term, and perhaps theoretical, I was asking in that case what ‑‑
how would our debate differ from the older debate here?

DR. KASS: Okay. We could use some help at headquarters on this topic. I
mean, I don\'t know ‑‑ I haven\'t heard anybody say this is not
interesting or not important. The question is how to do it and to do it
well.

And since you have an assignment for something on the other topic due in
two weeks, let\'s make this optional. But it would be very nice if there
were a subgroup of this ‑‑ of the members who are especially interested
in this if we could hear from you just by letter of either reflections
on this conversation, suggestions for how to proceed, and we will try
to, in light of that, see where we should go next on this topic and how
to do it fruitfully and usefully.

With the usual kind of lack of clear and coherent structure of such a
preliminary conversation, let\'s declare this one a success, take a
break, and come back, oh, at 25 of 11:00 for the regulatory discussion.

(Whereupon, the proceedings in the foregoing matter went off the record
at 10:17 a.m. and went back on the record at 10:44 a.m.)

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

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

PROF. FUKUYAMA: Sure.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

DR. KASS: Thank you very much.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Thanks.

DR. KASS: Rebecca, thank you very much.

Let me recognize Mary Ann and then Jim Wilson.

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

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

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

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

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

DR. KASS: Thank you.

Jim Wilson?

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

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

(Laughter.)

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

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

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

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

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

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

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

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

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

DR. KASS: Frank, did you want to join in?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

DR. KASS: Thank you very much.

Let me make a couple of comments.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

DR. KASS: Mary Ann, please, you want to respond?

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

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

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

DR. KASS: Thank you.

Elizabeth, please.

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

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

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

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

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

DR. KASS: Dan, please.

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

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

DR. KASS: Thank you.

Mike, Alfonso, and Gil, please.

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

DR. KASS: Alfonso?

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

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

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

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

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

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

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

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

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

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

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

DR. KASS: Paul?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Charles?

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

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

DR. KASS: Very good.

Let me ask the Council\'s consent to ‑‑ if I\'m not mistaken, we have
three public comments on the list. Is that correct? Three?

Would Council ‑‑ rather than take the scheduled break, and then
reconvene, since we have I think public testimony from three people,
could we take this now and then adjourn afterwards, since we\'re already
together and we don\'t want to make lots of people sit extra time? If
all these people are here. We did say it was going to be at 12:00.

So is Mo Woltering from the American Life League here? And is Richard
Doerflinger here? And is Susan Poland here? Is that the right
pronunciation.

MS. POLAND: Poland.

DR. KASS: Poland? Would you mind going ‑‑ if we began now? Then, let\'s
go in that order. Mo Woltering of the American Life League, please step
to the microphone. It\'s on.

MR. WOLTERING: I\'d like to thank Dr. Kass and all the members of the
Council for the opportunity to present these remarks. I\'m the Director
of Public Policy for American Life League.

My remarks today center around a very simple fact that\'s been scarcely
mentioned in the discussions of this Council and even the larger
national and international debate surrounding embryonic stem cell
research and human cloning. However, I believe this fact has a profound
significance for the discussion that is currently taking place.

The controversy surrounding embryonic stem cell research and human
cloning eventually returns to the debate over the moral status and value
of the human embryo.

And with this in mind, I would like to ask the Council to reflect for a
moment on one simple fact: that human embryos are either boys or girls.
This is an indisputable fact that\'s very seldom mentioned. The human
embryo, from the very first moment of life as a single-celled embryo, is
either a boy or a girl. That is, either a male or female.

Every high school student, in fact, learns this in biology class. One\'s
sex is determined by chromosomes which are present at the very beginning
of one\'s life as a single-celled creature. So I would ask you to keep
in mind that when you are talking about human embryos you are talking
about male and female human embryos. Knowing that every human embryo is
either a boy or a girl adds an important perspective to the moral status
and value of the human embryo.

One\'s sex is probably the most fundamental component of one\'s personal
identity. And we know this when we reflect upon ourselves. We also know
this when we reflect upon our everyday encounters. The sex of a person
is the first thing we notice when we meet people on the street, and
it\'s a major determinant of how we interact with people.

We will never be able to empirically confirm the presence of the soul,
but we know that in order for a person to exist a living, human body
must exist. And we know that human bodies essentially come in only two
forms ‑‑ male and female.

At the single-cell stage, we can identify a living male or female human
body. At the most ‑‑ one of the most fundamental components of personal
identity is present at this very beginning stage of life. I believe that
this alone is enough reason to recognize the personal rights of the
human embryo.

So I think here we must be honest. Many are apprehensive about
recognizing the rights of male and female human embryos.

As we all know, many widely accepted practices subject human embryos to
death. Here I\'m referring to the practices of IVF, embryonic stem cell
research, even contraceptive practices which prevent the implantation of
the embryo.

Clearly, if we were to boldly recognize the personal rights and the
dignity of the human embryo, we must then reject all these practices
that I have just mentioned.

The President\'s Council on Bioethics has a critical teaching
opportunity here. History is filled with examples of societies that
accepted a mistaken understanding of human dignity, and they allowed
horrible crimes to take place against innocent people, yet people came
together to correct those mistakes and to defend the dignity of the
person.

You have a chance to lead Americans to a renewed understanding of human
dignity, and I ask that you overcome all the apprehension. Human embryos
are either boys or girls.

Thank you.

DR. KASS: Thank you very much.

Richard Doerflinger, United States Conference of Catholic Bishops.

DR. DOERFLINGER: Thank you. I wasn\'t going to address the Council
again, but when I saw such a short list I decided to help the members
earn their per diems.

I want to begin by saying how honored I was to be given respectful
attention by Dr. Outka in the session yesterday. I want to offer two
clarifications on his description of my views there, however. He seems
to attribute to me the view that there is no moral difference between
destroying so-called spare embryos and specially creating embryos for
research that will destroy them.

And he also says that John Robertson accepts my point on that in order
to point to the opposite moral conclusion about both.

First, it was really Dr. Robertson\'s point to which I was responding.
My paper was written as a response to Robertson\'s. But, more
importantly, I don\'t think I\'ve ever argued there\'s no moral
difference between the two practices.

Obviously, I think the practice of specially creating embryos simply to
destroy them for research is more morally abhorrent in more ways, just
as it would be more horrific to conceive a child solely in order to
abort her for organs than to abort in some other circumstances. My point
is just that that does not mean the other abortions are morally right.

The point I was trying to make is this: there is often some measure of
selfishness in our reasons for conceiving children, just as in our
reasons for doing many other things. As a Catholic, I tend to attribute
that to original sin.

For example, in having a child, I may have in the back of my mind that I
would like this child to go to college and achieve things that I never
did, to give myself some vicarious satisfaction. And in that sense, I am
treating that child partly as a means.

But this becomes much more problematic if we are treating our offspring
as mere means in ways that do them great harm for the benefit of others.
And if we explore our reasons why so many of us, quite rightly, strongly
object to creating embryos in order to do them harm for research, we
will find in our feelings the roots of an argument that it is wrong to
harm embryos generally. But I didn\'t equate the two practices.

Secondly, I wanted to comment briefly on the slippery slope. I wanted to
confirm what Dr. Krauthammer said yesterday. During the debate on use of
spare embryos in Congress, every member of Congress, every Senator,
claimed to oppose specially creating embryos for research, by cloning or
other means.

Outside research groups and patient advocacy groups declared the same
ethical position, arguing, for example, that the Clinton guidelines on
stem cell research kept this research within ethical limits precisely by
excluding any involvement in special creation of embryos for research.

But when the debate switched to cloning for research, many of these
Senators and outside groups immediately switched their position and
endorsed what they had previously condemned.

I am tempted to agree with what Dr. Rowley said yesterday that this was
not a slippery slope, that these people always knew where they wanted to
go in the end. But that seems to suggest that they were simply being
deceptive in their first position and raises the question why we should
believe some of their claims now.

The rule \"fool me once, shame on you; fool me twice, shame on me\"
seems to hold here. I do think there was a great deal of insincerity in
the earlier claims to share moral concerns of the rest of us about
specially creating.

My point is simply that I have no reason to believe that the slope does
not extend further down. I want to raise two things about ‑‑ does this
stop with the embryo?

The latest bill, alternative bill to be introduced ‑‑ and it has been
called a compromise by its sponsors, S.2076 ‑‑ does not, like some
previous bills, ban the implantation of cloned embryos in the womb. It
allows the implantation of cloned embryos in the womb, as long as that
is not done for the purpose of \"creating a cloned human being\" by
which I assume we mean a born human being or the bill would be
incoherent.

In other words, this latest bill already endorsed by some Senators would
allow implanting cloned embryos in the womb, to grow them to a certain
stage of gestation at any time before birth, and then kill them for
their organs.

The other reality is that when asked to proffer examples in animal
models of what therapeutic claims can be made for therapeutic cloning,
supporters have noted two studies. The first involves trying to make new
kidney tissue for cows, but it required growing the cow embryos, the
cloned cow embryos to fetal stage and then harvest their kidneys.

The second was an attempt to cure an immune deficiency in mice, and that
did not work until they actually brought the embryo to live birth and
then harvested its adult stem cells for treatment in the original mouse.
In fact, there are no models at this point of therapeutic cloning that
stays at the embryonic stage.

And I would like to offer for any Council members who are interested a
document that offers a little snapshot of the advances that are being
made now against some of these diseases without using any embryonic stem
cells or cloning.

Thank you.

DR. KASS: Thank you very much. If you\'d give the documents to the staff
table, we\'ll see that everybody receives these.

The last comment is from Susan Poland speaking as a private citizen. Ms.
Poland, welcome.

MS. POLAND: Thank you. Mr. Chairman, members of the Council, my name is
Susan Poland, and I work as a library researcher for the Bioethics
Library at Georgetown University.

However, I am speaking only on myself and on behalf of no other entity.
I\'m also speaking from my experience as one of the first 10 women
police officers in New Hampshire, and also as one of the first four lab
techs in basic reproductive research at the Jones Institute in Norfolk,
Virginia.

Recently, I co-authored a bibliography on cloning. Others I had done
were on gene patenting and bioethics commissions. So I\'m also speaking
from what I learned from those.

And I have two basic insights, one comment on terminology, and then I\'d
like to really spend most of the comment time on illustrating what it
was like to be, in 1985, a first-hand account of doing unregulated in
vitro fertilization basic research.

First, a clone is a group of genetically identical offspring or progeny.
It implies birth, and, therefore, I think that reproductive cloning is
redundant, and therapeutic cloning is a misnomer and misleading, like
gene therapy is. I would like to see you use the term \"IVD\" for in
vitro division or duplication.

If you\'re going to have implantation into the uterus in hopes of a
pregnancy, IVD/ET, just like IVF means in vitro fertilization, not
necessarily followed by implantation, or IVF/ET.

My first comment or insight in working on the cloning bibliography is
that the U.S. patent system is the most powerful and most unique law
enforcement regulation that this particular government has for
controlling research done abroad and in the U.S. You cannot really
regulate the scientific research, but you can regulate and control
access to the patent system.

And I was expecting or hoping that like you have IRBs or a super IRB for
FDA, you would have something like RAC, because the patent system right
now is overextended. It does over 10,000 patents applications in one
year. It took over 40 years to reach the first 10,000 applications.
Those people are not qualified, I believe, for adequately evaluating
whether or not research is done correctly under bioethical principles.

Second insight ‑‑ that was a short-term insight. A long-term insight is
that the legacy, I believe, of this group will be its impact on human,
and the definition of human to further councils and lawyers in the
future, maybe not in my daughter\'s generation but the generation
following that.

If you take a look at what\'s happening with cooperative robotics,
autonomous robots that are making decisions, I wonder if we\'re going to
define \"human\" as one cell, whether it\'s an embryo or what, and go
back to the racist policies or miscegenation and one drop of blood.

And now I\'d like to go into explaining what it was like to be a person
that walks into a bioethic ‑‑ excuse me, into a basic reproductive
research laboratory with a background in law enforcement when you had a
.38 Smith & Wesson on your hip, but you also had some experience with
bioethics and the issues.

The first time I was there they looked at me like, well, are you going
to stop the conversation talking about law, or are you going to just
tell us what to do as a bioethicist? And I told them, \"No, bioethics is
not a badge.\"

Lawyers have ‑‑ lawyers and policemen have judges. They give you a final
decision. Bioethicists and theologians have no judge. And so the
discussion continued, and they would talk, and it was a very small
group. It was very similar to what I believe 19th century Britain was
for discussing science.

We had close communications. I worked with Gary Hodgen, who you may know
left NIH in 1984 because he could no longer do embryo research as a
bureau chief. And the Joneses ‑‑ Howard and George‑Anna Jones had left
Johns Hopkins sometime before because they were no longer allowed to
teach because they had reached the age of 70.

So we were working with our small group. And, like I said, I was one of
the first four. There were close ties to Patrick Steptoe and John
Edwards in England. Everyone knew everything. This was in the age when
there were no faxes. Well, they were relatively new. No cell phones, no
internet. You were lucky to get things.

And at the time, in the U.S., what had happened with us doing basic
research was a scarcity of materials. We were working basically with
animals, and, when we could get them, human materials. But because of
the fall of the Marcos regime, we were not allowed to get very many
primates. They are very hard to get. And when you could find a monkey to
work on, if you were using human material, just like with vaccines,
three times of exposure to human hormonal material would immunize the
monkey and you would no longer get valid results.

So, consequently, a good deal of research in IVF was done using the
litter-bearing models of mice, which their ovaries do not react the same
as, say, a singleton birth.

At the same time when we were sitting there, I remember one of the
business meeting discussions like, well, what do you think? Do you think
we should screen for AIDS? That seems to be a new disease. And you know
what has happened since then.

I also sat in a meeting with Etienne Balieu, who was running
Roussel-Uclef. We were doing work on RU-486 with one other woman. It was
a small group of men and us two women. We were the only two people that
thought we still agree with diaphragms, because we like control of our
own bodies. Forget about giving us drugs that we can\'t shut out or
whatever.

At the same time we were working with RU‑486 on monkeys who were giving
still birth, or the newborns would die relatively soon, Roussel-Uclef
had signed an agreement with the Chinese government to test on people.
When you have a policy of one birth or less, it\'s very easy to allow
your people to go sterile.

Also, at the same time, in the summer of 1985, a professor named Akira
Iritani, who is still in practice and still working today, came over.
And it was sort of like the beginning of 2001 when you see the bone
going up in the air from the cave man, and you see the space ship.

We had just gotten our first micromanipulator, a Japanese machine that
Professor Iritani had used quite a bit. He had a graduate student, much
like Briggs & King ‑‑ King being the expertise for Briggs with all the
insight. He had a graduate student when he showed us at the end of his
term staying with us that could do two to three hundred embryos in an
afternoon, splicing them, which we would call now embryo-splitting or
blastomere separation.

And one of the slides at the very end was a picture of five identical
goats born by an eight-cell embryo. And I thought my God, there you have
the perfect drug testing system for a pharmaceutical company. I have as
yet, as a professional researcher, to see anything in print. If you have
any sway with people at the NIH, both at NLM and with research to get
more Japanese work put out into the U.S. mainstream for people to know,
that would be very nice.

China obviously takes one view based on a Confucian and socialist
system, or a Communist system, rather, of human life. Japan takes a
different view. Professor Iritani shocked even me when I discovered that
in January this year he announced that his group and a different
university is viewing genetic engineering ‑‑ had actually inserted a
spinach gene into a pig, and then produced two successive birth
generations. From my Western mind, I don\'t mix plant and animal
kingdoms.

And then, lastly, back in 1985, we were there watching what was
happening in 1984 with the Medical Infertility Procedures Act when it
was passed in Australia in Victoria. And the \"hot dogs and cowboys\"
were going to be put in their place by the legislators.

Well, they certainly did. They emigrated to the U.S. as IVF Australia,
became IVF America, and today they are now IntegreMed, Incorporated,
responsible for one-sixth of all IVF births in the U.S., and our local
outlet is Shady Grove Adventist Hospital.

So I feel that when Australia came into the U.S., what basically we lost
was that very close-knit tie of research and clinical care, because it
suddenly overwhelmed the system and it became just clinical care and
consumers.

When I was working there in Norfolk doing basic research, we got human
materials. There was a pecking order. Any human material was first used
for patient care, and those people there would decide which ones were
the best ones with the best opportunity of going on to help these people
that wanted to have babies.

Anyone else would come second for research, mind you that not the
best-looking embryos always were the best ones that went and implanting.
So we had to rely on their judgment.

We did use cadaver eggs. I\'m grateful for the one woman that did donate
her ovarian tissue. But the eggs, of course, were dead, as I believe
many of the 100,000 embryos are that are sitting around in the nitrogen
tanks throughout the country.

But both groups, the clinical practice and basic research, were in
service together on improving care. I\'ve never seen such a group of
remarkable people with high esprit de corps.

And there wasn\'t a feeling that this is a researcher-subject
relationship or a doctor-patient relationship. We were more or less
fiduciaries, trying to do best for individual people and yet also trying
to do best for society by improving the science.

My own feelings about the moral evaluation of this, having been given
the power to use my own judgment when I was 23 to use deadly force to
kill a person if I had to, was that this wasn\'t destruction of embryos.
This was actually loss. There was a real grief every time we had to kill
an animal or lost an embryo that we just didn\'t work.

I\'m sorry. Am I over my limit? Is that just some ‑‑

DR. KASS: No, that\'s just some ‑‑ that\'s just some ‑‑

MS. POLAND: Okay. And today I know that talk about the Human Embryology
Authority and CCNE in France, while they have asked and joined Germany
to put a ban through, or look at regulating human embryo research and,
in particular, cloning, they also ‑‑ the CCNE has asked the President to
look at establishing its own authority like the HEFA.

They also use, by the way, the British term, which is cellular nuclear
‑‑ cell nuclear ‑‑ CNR. I\'m sorry. Cell nuclear replacement I believe
is what it is.

I was going to ask you, and then respectfully request, and actually I
think the term I want is beg ‑‑ beg you to regulate this. It was very
scary to do IVF, which is fertilized or sexual reproduction, and now
you\'re looking at in vitro asexual reproduction. To do it in an
unregulated atmosphere because you didn\'t know what you were going to
do, if you were going to hurt someone, and where the government would
draw the line suddenly.

And that\'s about all I can do is ask ‑‑ there\'s a balancing mechanism.
My own ‑‑ as I started to say, my own moral feelings about this, having
been given deadly force, I have discovered have changed. And they evolve
the more and more information I take in.

Thank you.

DR. KASS: Thank you very much.

Did you want to say something, Janet?

DR. ROWLEY: I just wanted to correct Ms. Poland in terms of the
definition of cloning, because cloning has been used in the biological
community for many, many years. And its first use is ‑‑ that I am aware
of was really when you had a cell line, you knew that it was
heterogeneous, and you wanted to take the cells in that cell line and
begin new cell lines derived from a single cell, and that was called
cloning.

So that, then, you had a homogeneous cell line derived from this
heterogeneous cell line. So it in no way implies live birth.

DR. KASS: Thank you.

Any comments? Could I ask ‑‑ is Ms. Poland still here? Could I just ask,
as a point of information, are you aware of ‑‑ this is a question, too,
as librarian. Are you aware of any overarching study on the practice of
IVF along these lines? I mean, has there been any review studies that we
‑‑ that ‑‑

MS. POLAND: On the safety of IVF?

DR. KASS: No, not on the safety. Just on, in fact, the practice. I mean,
you were talking really something about the unregulated character or the
practice, the profession ‑‑ the society has its own guidelines, which it
has ‑‑ which it has promulgated, and most of the members of that society
abide by it. But there are also other groups that do this practice that
are not members of the society. Is there any ‑‑ are there any studies?

MS. POLAND: For clinical care, I\'m not aware of any. And by the way, I
did give Ms. Zwanziger one cite, which is the Hayflick 1965 cite, which
relates to ‑‑ it\'s a seminal article about the number of times you can
actually reproduce a cell. It\'s supposed to be 50 generations, and I
explained to her about checking to see if additional ‑‑ but I can look
into that if you\'d like, if you can tell me later more ‑‑

DR. KASS: We\'ll make the request more precise, and we might be in touch
with you. Thank you very much.

MS. POLAND: Okay.

DR. KASS: Robby George, and then ‑‑

PROF. GEORGE: Yes. Can I ask Richard Doerflinger a question?

DR. KASS: Is Richard still here? Yes, please, Richard.

PROF. GEORGE: Richard, since you\'re here, I thought I could get an
answer to a question that frequently comes up, and it\'s this. Does the
position of the Catholic Bishops Conference, or the Catholic Church
generally, on the issue of the moral status of the embryo and what
public policy ought to be on that depend on a view about the infusion of
a spiritual soul in the early embryo?

DR. DOERFLINGER: No. There have been a lot of speculations during the
course of Catholic history about ensoulment. Even during times when
people thought they were pretty sure based on the biology of Aristotle
and the philosophy of Thomas Aquinas that the early embryo was not
ensouled, it still rejected abortion as an act that shows disrespect for
this developing life that has a human destiny, that God is at the very
least forming to prepare for a soul.

The current teaching is that abortion and destruction of embryos is
wrong, first of all, because it destroys a living member of the human
species, and that that\'s enough to deserve our respect.

And, secondly, that since we cannot be sure that the early embryo is not
‑‑ does not have an immortal soul that when you are destroying that
embryo you in addition risk the full gravity of killing a human person
in the full sense. But ensoulment is not the factor that means the
difference between moral right or wrong or even the difference between
something that would be seen as an abortion as versus contraception. Is
that ‑‑

PROF. GEORGE: Yes, that answers it. Thank you.

DR. KASS: Thank you very much.

Thank you all for your wonderful work, your endurance. The meeting is
adjourned.

(Whereupon, at 12:18 p.m., the proceedings in the foregoing matter were
adjourned.)