Hilton, Crystal City
2399 Jefferson Davis Highway
Arlington, VA 22202
April 26, 2002
R. Kass, M.D., Ph.D., Chairman
American Enterprise Institute
S. Dresser, J.D.
Washington University School of Law
H. Blackburn, Ph.D.
University of California, San Francisco
W. Foster, M.D.
University of Texas, Southwestern Medical School
Johns Hopkins University
Michael S. Gazzaniga, Ph.D.
P. George, D.Phil., J.D.
Ann Glendon, J.D.,
B. Hurlbut, M.D.
F. May, Ph.D.
Southern Methodist University
McHugh, M.D.Session 6: Regulation
1: Regulatory Approaches to New Biotechnologies
Johns Hopkins University School of Medicine
C. Meilaender, Ph.D.
Janet D. Rowley,
The University of Chicago
J. Sandel, D.Phil.
Q. Wilson, Ph.D.
University of California, Los Angeles
Session 5: Enhancement 1: Therapy
Session 7: Public Comments
SESSION 5: ENHANCEMENT
THERAPY VS. ENHANCEMENT
CHAIRMAN 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
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
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?
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
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.
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
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.
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.
CHAIRMAN 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.
CHAIRMAN 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.
CHAIRMAN KASS: You mean changing the maximum
life span is —
DR. MAY: That's right.
CHAIRMAN KASS: Yes.
DR. MAY: That's right.
CHAIRMAN 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 —
CHAIRMAN KASS: Deliberately.
DR. ROWLEY: Okay. So this is — that's fine.
CHAIRMAN 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
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.
CHAIRMAN 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 —
DR. BLACKBURN: A very small point.
CHAIRMAN KASS: Please.
DR. 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.
CHAIRMAN KASS: Yes.
DR. BLACKBURN: I'm not sure if that was clear
to everybody. I thought that it was worth clarifying that technical terminology.
CHAIRMAN 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."
But that's over now.
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
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.
CHAIRMAN KASS: Thanks, Charles.
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
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
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.
CHAIRMAN 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
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.
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.
CHAIRMAN 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.
CHAIRMAN KASS: Well, I'll sit back.
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
— 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
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.
CHAIRMAN KASS: Thank you.
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
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
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 —
CHAIRMAN KASS: That's not a disorder anymore.
DR. MCHUGH: Excuse me?
CHAIRMAN KASS: I said that's not a disorder
DR. MCHUGH: That's not a disorder anymore, but
CHAIRMAN 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.
Massachusetts has a lot to answer for.
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
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
CHAIRMAN 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
PROF. DRESSER: Mike?
DR. GAZZANIGA: Well, I want to take credit for
having paid for two of Paul's two-shot enhancers last night —
— 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
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
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.
CHAIRMAN KASS: Michael, thank you.
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
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
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.
CHAIRMAN 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
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
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?
CHAIRMAN 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.
CHAIRMAN 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
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
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
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?
CHAIRMAN KASS: Please.
PROF. FUKUYAMA: I have a suggestion.
CHAIRMAN 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 —
CHAIRMAN 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.
CHAIRMAN 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
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.
CHAIRMAN KASS: Jim, to this?
DR. WILSON: Yes.
CHAIRMAN KASS: Please.
DR. 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
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.
CHAIRMAN 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.
CHAIRMAN 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.
CHAIRMAN 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.
CHAIRMAN KASS: Please.
DR. 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.
CHAIRMAN 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.
CHAIRMAN KASS: You could fix that, you know?
DR. GAZZANIGA: It goes on for months, and he
finally calls up Paul and he says, "Paul, I've got this problem."
"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."
Would you take it?
CHAIRMAN KASS: I've been to see him.
DR. MCHUGH: I wouldn't prescribe it, but how
CHAIRMAN 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
CHAIRMAN 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.
CHAIRMAN KASS: No, no. I understand.
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 —
CHAIRMAN KASS: I'd just — I mean, to be is
to be awake. And if I am flagging, then all kinds of human possibilities
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?
DR. 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 —
DR. GEORGE: Leon, just on this point? Or is
it — it's Robby.
CHAIRMAN KASS: Robby. Sorry, Robby.
DR. 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 —
DR. BLACKBURN: It's the sin tax, right?
CHAIRMAN 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 —
— that disclaimer, isn't it?
PROF. MEILAENDER: Well, I was making it on your
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
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
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 —
CHAIRMAN KASS: Do they come in a bottle?
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.
CHAIRMAN KASS: Would someone like to join that?
DR. MCHUGH: I'd like to join that and agree
CHAIRMAN 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 —
— 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.
I emphasize some because —
— there are quite a few who go and find another doctor to do exactly
what they want done.
CHAIRMAN 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
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.
CHAIRMAN 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
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.
CHAIRMAN 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
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 have 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.
CHAIRMAN 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
DR. KRAUTHAMMER: Well, that's precisely where
I think we ought to focus, because otherwise we would be recreating an
CHAIRMAN 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?
CHAIRMAN 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.)
SESSION 6: REGULATION
REGULATORY APPROACHES TO NEW BIOTECHNOLOGIES
CHAIRMAN KASS: All right. We convene for the
second-to-the-last session. We will have a session for public comment
beginning shortly after noon, after 12:00, but this session is an exploratory
conversation on the subject of regulation of biomedical technologies.
And it's a subject that Frank Fukuyama has especially been interested
Since I mentioned it in the first meeting and Frank prepared the — a
short memo at our request, Frank, do you want to say something further
about it to get started? We've had a couple other people prepare to lead
off in response, but would you like to just hit a couple of high points?
PROF. FUKUYAMA: Sure.
CHAIRMAN KASS: And then, we'll take it from
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
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
So that, for example, the line of questioning that Bill started, you know,
that right now we want to do things to embryos that aren't older than
14 days, but supposing down the road someone will decide that you actually
need to do something to fetuses, you know, one way of solving that —
I mean, if your real worry in the short term is that slippery slope, then
clearly one solution to that is to set up a regulatory structure that
would cut things off at 14 days and say, no, you cannot — you know, we're
going to permit cloning or stem cell research up to this point but not
further, and put a break on that particular slope.
And there's actually a model out there, which is this Human Fertilization
and Embryology Agency, in Britain that does that, that regulates embryo
research. It regulates their IVF industry and establishes these kinds
of rules for, you know, that sort of experimentation. And they've already
done it. In fact, it's a 10-year old agency.
And I think that, you know, I personally do not have any concrete ideas
about, you know, what the institutional design for such an agency or —
you know, first of all, I'm not wedded to the fact that we need a new
agency. I think simply that we need to think about it, but — and I'm
not wedded, certainly, to any particular institutional design.
But I do think that it is an issue that we need to look at very concretely,
because there really are holes in the current structure. I mean, the one
— the biggest hole really has to do with the whole, you know, private
sector and the whole private, you know, biotech industry, which does not
fall under the NIH's rulemaking power, which, incidentally, the British
law, you know, fixes.
There is no such distinction between public and private in the British
regulatory system. And that's a problem that comes up with — you know,
with an agency like the RAC, the Recombinant DNA Advisory Committee.
Janet and I were talking about this over breakfast. I think that that
was an exemplary, you know, instance of self-regulation by scientists,
and it worked — you know, is a system that worked, you know, quite well
in its inception.
My understanding is that a lot of people that work with it now think that
the industry and the — you know, the structure of scientific research
in the United States at this point has outgrown that particular structure,
because there is so much that's now done, you know, in the private sector.
Now, I don't necessarily believe that — I'm not trying to argue that
we need more formal regulation or that self-regulation is impossible.
I just think that, you know, it's a serious set of issues that — you
know, that deserve to be looked at.
So let's — all right. Let me just stop there.
CHAIRMAN KASS: Thank you very much.
I have asked Rebecca Dresser to open up response with — after Frank's
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
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
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
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
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
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
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
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.
CHAIRMAN KASS: Rebecca, thank you very much.
Let me recognize Mary Ann and then Jim Wilson.
PROF. GLENDON: Well, I, too, am very grateful
to Frank for opening up these questions of regulation and institutions,
and to him for recognizing the political dimensions of the problems that
we are going to be addressing. And so I would add my voice to those who
encourage the Council to explore these matters further.
I think that the political discussion of regulation and institutions has
to begin a step earlier with the question of priorities. I think my remarks
in the last session might have been misunderstood by some of those who
commented on the topic.
When I raised the question of allocation of scarce resources, I was not
trying to make a point about equality, but, rather a point about priorities.
And I think the beginning of wisdom in this area has got to be an investigation
first of, what priorities has our society established already in the area
of biomedical research and biomedical technology, either intentionally
or by default? Where are we going? And then, is that really where we want
to go? How are those priorities established? is a political question.
I would also suggest that as we explore those kinds of issues that we
take account of the effects of a major demographic change on the politics
of this whole question. I referred earlier to the aging of the baby boom,
and I referred to it in the context of increasing demand for certain kinds
of services that have a moral dimension.
But it has another effect. And if you look a little bit further down the
line, the aging of the baby boom is causing a change in the ratio of active
workers in the labor force to persons in the population who are dependent,
retired and frail, elderly, very young, etcetera. That second change may
very well have some very sinister implications, not only for enhancement
but for other desires of the aging baby boom population.
CHAIRMAN KASS: Thank you.
DR. WILSON: I will join in the praise for
Frank, and I was especially impressed with Rebecca's very careful analysis
of this. There are only a few points I can add.
My discontent with the conversation we had over the last hour — a discontent
I am unable to mask because I lack sufficient control of my facial muscles
— 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
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
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
But with respect to those that are appropriate, people must be allowed
to make money doing this. Because if they're not allowed to make money,
the appropriate germ line strategies will never be pursued, and people
who might benefit from these strategies will never have the opportunity
to do so.
CHAIRMAN KASS: Frank, did you want to join in?
PROF. FUKUYAMA: In response to that, I think
there's a tremendous amount of work to be done. It was my intention, actually,
in parallel with my service on this Council to, you know, get foundation
funding to basically do a project, you know, that would look at biotech
regulation that would do precisely that.
I mean, I have an ongoing study group that would call in regulators from
the different agencies and simply to talk and inform ourselves about,
you know, current problems. For example, I mean, and I think there's probably
a lot of consensus that this needs to be done quite apart from the ethical
concerns that we're supposed to address in this Council.
For example, you take the case of individualized medicine. The FDA, you
know, as a result of completion of the human genome project — the FDA
is going to have a huge problem in dealing with this, because you're talking
about medicines that are individually tailored to, you know, particular
genetic profiles for which the existing, you know, large clinical trial
model is simply not appropriate.
And, in fact, Catherine yesterday was saying that, you know, if you extract
a stem cell under her method, you know, by current FDA rules, you know,
that has to be considered a separate — you know, a separate drug that
would require separate FDA approval for every individual for whom you
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
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
I think the conceptual challenge is whether you can democratize in a certain
way — I mean, I think that there are a number of reasons for thinking
that that delegation is going to be more and more problematic as time
goes on, simply because the technologies will do things that will raise
ethical problems that people in the democratic — larger democratic society
will have problems. Not everybody, but — and different people have different
problems with different aspects of it, and there won't be complete consensus.
But it'll be much more controversial.
And I think that the self-interest of the epistemic communities cannot
be assumed to correspond to the interest of the society as a whole. That
is to say, researchers have their own ambitions and goals. There is clearly
a private biotech industry that's driven by, you know, its desire for,
you know, profits, and so forth.
And so the question is: can you modify the governance structure such that
it is not a pure delegation? Obviously, it has to be, you know, substantially
delegated. But can you open it up to some greater degree of public participation?
And here I want to divorce completely my own views of what that — you
know, what the rules ought to be.
I mean, I'm just saying procedurally it seems to me that we need to think
about whether there is a way of, you know, opening up that procedure and
democratizing it to a greater extent, you know, and taking it a little
bit out of the hands of the epistemic community to allow other societal
voices to — you know, to participate.
And I think that there are some models for that. It's sometimes — when
I've described this to people, they say very contemptuously, "What?
You're going to have an ethics regulatory agency, and so forth?"
But, in fact, you know, that is the idea behind the non-professional members
of IRBs, that you get, you know, social voices that don't have the same
set of interests that the biomedical research community does.
You know, the British agency also has similar rules for non — you know,
professional membership in its oversight board. And so I think there are
— you know, in democratic societies there are actually institutional
models where you can, you know, broaden the kinds of societal inputs that
— you know, that go into it.
Now, Rebecca may be perfectly right that given the deep — and, particularly,
the closer this gets to abortion and, you know, embryos, and so forth,
the harder it's going to be to come to any agreement whatsoever.
But I do think that, you know, and so it may not be possible to create
these institutions, but I think, you know, generically that's what we're
talking about. And then, there is some precedent for it, and so I think
we ought to, you know, think carefully about what that might look like.
CHAIRMAN KASS: Michael? Then I'll join the queue
myself. Michael Sandel?
PROF. SANDEL: Well, I appreciate very much Frank's
project, and I find it all persuasive. One small request that I think
would be helpful — Frank has referred to the U.K. licensing system, which
applies to the full range of these, and I think it would be very helpful
for the Council to — if there were a good account of that and what restrictions
they've decided on that could be distributed, I think that would be a
valuable thing for us to have, because there is a model out there — which
we may or may not agree with in all of its aspects — but I think we should
— it would be helpful if we could have a copy of it or an account of
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
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
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
And here's another area where including discussion of the restraints that
you might want to endorse and insist on, restraints having to do with
the number of days, having to do with the purposes to which it could be
put, having to do with whether the research could proceed if there are
already existing stem cell lines of that kind out there or not, which
the British case restricts, restrictions having to do with the requirement
of depositing the stem cell lines in a pool rather than privatizing them,
which I think the British one also includes.
It might be possible to make out an answer maybe not persuasive in the
end to Gil, but at least a substantive, a more fully developed answer
about how in practice people in category 2 would give concrete institutional,
practical expression to the restraints and to the restrictions. And this
would be a second area where spelling out the regulatory and licensing
aspects would be part of the moral argument, not a further consideration
to be dealt with in another report.
So I'm hoping that even in the report, which we don't have so far, on
cloning for biomedical research, it's possible to try to spell out, even
if in a provisional way, some of the regulatory restrictions that would
be associated with what we've been calling position two, those people
who take seriously the moral costs associated with sacrificing blastocysts.
And, well, what does that mean in practice, and how does that differ from
a view which would be indifferent to that moral dimension?
CHAIRMAN KASS: Thank you very much.
Let me make a couple of comments.
PROF. SANDEL: Could I add just one thing? The
Senate debate completely ignores this. There it's either for or against.
You're either for permitting the cloning for biomedical research or against,
and one way this Council could make a contribution by linking those regulatory
restrictions would be to show that there is another alternative.
CHAIRMAN KASS: Well, just — I didn't want to
comment on that, but you — since you came a second time, let me make
a small point. I mean, it does seem to me that thinking through the regulatory
possibilities is part of the prudential judgment about what to do, though
there is a kind of further question when one actually makes a recommendation
of what to do as to whether one says there could be regulatory possibilities
and, therefore, one judges this way, or one insists on being shown the
regulatory possibilities in advance before one signs on morally to a particular
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
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
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
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 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
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
So that is already embedded in one of the NIH committees, and a proportion
of the Genome Institute's research funds are earmarked for ELSI research,
so that the genetics community at least has embraced the fact that what
it does in the research arena is — should be viewed by communities other
than just geneticists. And I think that that is appropriate.
While I have the microphone, I'd just like to go back to some of the comments
that Mary Ann made, because she brought up the question of, what are our
priorities? And it seemed to me the bottom line she said was these are
politically dictated, and I — I wonder if, in fact, that is so.
You can say the priorities of where are we going are not determined by
political forces, but, rather, by events that are driven by others, including
scientists, engineers, etcetera, who come up with discoveries that then
have an impact on society. And what society is doing is responding to
these new areas and trying to figure out what kind of a response is appropriate
rather than society saying, "We're going to go and do this kind of
new thing." And so I would just question that.
CHAIRMAN KASS: Mary Ann, please, you want to
PROF. GLENDON: Just a point of clarification.
I didn't say they were politically dictated. I said it's a political question
and something that we ought to understand as a starting point to what
extent they are governed, as you say, by events — that is, by default,
and to what extent there is intentionality.
CHAIRMAN KASS: Would you say another sentence?
Because I'm not sure everybody understands — would understand what you
mean by "it's a political question."
PROF. GLENDON: It's a political question whether
a society likes the direction in which it is going, either by choice or
by inadvertence. It's a subject for deliberation in a democratic polity.
CHAIRMAN KASS: Thank you.
DR. BLACKBURN: Yes. I really very much want
to endorse what Janet just said. Leon used the phrase "all scientists"
— I forget, but I think it's been very clear from the history that scientists
have had a strong voice in wanting to self-regulate — the RAC being one
And to answer your — you said you wondered if there was something in
the National Academy's recent report on — this was the report on stem
cells and the future of regenerative medicine. Included in our handout
were the first three chapters excerpted but not the last one, the findings.
But I have the original with me, so it — let me read you the recommendations,
which directly are pertinent to this.
So the recommendation after finding six was a national advisory group
composed of outstanding researchers, ethicists, and other stakeholders
should be established at NIH to oversee research on human embryonic stem
cells. The group should include leading experts in the most current scientific
knowledge relevant to stem cell research who can evaluate the technical
merit of any proposed research on human embryonic stem cells.
The roles for the group could include evaluation of potential risks to
research subjects and ensuring compliance with all legal requirements
and ethical standards.
So I think that perhaps an implication that might have been taken from
Leon's phrase of all researchers, which the scientists are not interested
in self-regulation, I think that's — this is just manifestly arguing
this is not the case, that there is serious interest in self-regulation.
CHAIRMAN KASS: Dan, please.
DR. FOSTER: Well, I think the idea of having
industry involved here is a very good one for dialogue. Most of these
— most of big pharma have ethical committees associated with them. But
my view, Leon, would be in this dialogue that you probably ought to have
somebody from big pharma that is not so much — they buy biotechnology,
and so forth, but they're not as much in it as they are in the small start-up
companies, and so forth.
So, I mean, I think that, you know, you get somebody from Tularec or Genetech
or something like that as well to come in — would be very helpful to
— both to let them hear what we had here and what their suggestions would
be about that. So I personally think that would be a very good idea for
us to do.
CHAIRMAN KASS: Thank you.
Mike, Alfonso, and Gil, please.
DR. GAZZANIGA: The shortest remark of this panel:
I agree with Janet.
CHAIRMAN KASS: Alfonso?
DR. GÓMEZ-LOBO: Yes. I want to voice a brief concern about the regulatory
model which consists in appointing committees. And I'll just do it by
mentioning the fact that some colleagues of mine, British moral philosophers,
have serious doubts about the human fertilization and embryology agency,
because, you know, who gets appointed there is really crucial.
And their criticism is that rarely, if at all, people who are known to
stand for protection of embryonic life get appointed. So, I mean, it ends
up being a kind of rubber stamp for a number of projects that are morally
very questionable. So I think that's something to keep in mind.
CHAIRMAN KASS: Who was it? It was Gil and then
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
It will be much more acute with some kinds of questions than others in
terms of the range of issues that Frank has drawn up. But that problem
of complicity that — the legitimacy that law confers is always going
to be hard here.
CHAIRMAN KASS: Paul?
DR. MCHUGH: I want to — I'm glad to follow
after Gil always. But I also am pleased to follow after him now, because
in relationship to what's being said about self-regulation, the — in
the pharmacological and neuropharmacological realm, the largest organization
in our country is the American College of Neuropsychopharmacology. And
I'm the present sitting chairman of their Ethics Committee.
And I believe that it is a developing program in which issues that are
problems are seen first, and then later dealt with. And I think the process
and the willingness of such organizations is quite clear.
CHAIRMAN KASS: Well, I guess I'd like to underscore
in part Gil's point on this, too. The professional self-regulation —
there's a certain homogeneity of viewpoint as to at least what the domain
is. This is quite apart from any particular vexing question such as the
embryo-related questions would introduce.
But there is a certain kind of guilt mentality in those things in which
the larger considerations that come out when you have a group of this
sort talking don't generally get built into the conversation. I'm always
surprised by what I hear about the table — that is to say, that very
smart and thoughtful people interested in the same topic don't see it
in the same way.
And if I simply hung out with, you know, the like-minded, professionally
or otherwise, the questions just wouldn't look the same, and the industrial
self-regulation, where all of these various institutions have their own
ethics committees — I mean, it's — you get what you pay for very often
in those places, and it's a very peculiar thing to have critics — it's
like the company union very often.
And without impugning the judgments of anybody who works there, it is
somewhat odd to bring in house people who, after the due wringing of hands,
will endorse what the company is — the most profitable course.
Okay. And then, finally, the RAC is a wonderful but very limited example.
It's limited by the fact that the question — this touches on something
Frank said earlier. The question — the RAC grew out of the concern which
led to the Asilomar Conference, in which, strangely enough, I think everybody
saw that they were somehow in the beginning — at the threshold of the
genomic age. The word didn't exist, but that this was the beginning of
something very large.
There was anxiety about this very large thing. There were public critics
of this very large thing. And all of the anxieties were allowed to be
focused on the one question of the safety of the little recombinant organisms,
should they get out of the lab.
And there were, of course, local threats in Cambridge, Massachusetts,
etcetera, etcetera, that may have focused — but, once again, the question
about the safety of the organisms, just as the safety of cloning, don't
go to the heart of what it is that one actually is concerned about once
the technologies are safe and ready for use. It's the use of the powers
when they're safe rather than the hazards of making them safe.
And one of the things at the Asilomar Conference, several Soviet scientists
were invited to this conference, and they sat in the front row and photographed
all the slides. They didn't say a word.
And because the scientists, in their decency and naivete, thought that
the only question under discussion was the safety of the microorganisms
that were being engineered for use, no one paid any attention to the implications
for possible bacteriological warfare that were implicit also in the kind
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
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
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
CHAIRMAN KASS: It looks like we may have exhausted
this for today. Do I have the sense of the group that this is a topic
to which we don't make a definite long-term commitment at this point,
but we are interested in it enough to take it to the next stage, to gather
the information about what's happening in Canada and in Britain in this
particular area to invite in people from perhaps some of the bodies that
already do practice regulatory activity in the area of biotechnology?
And maybe set aside some time at the next or the meeting after next where
we go into this more deeply?
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
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
CHAIRMAN KASS: Very good.
SESSION 7: PUBLIC COMMENTS
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.
CHAIRMAN 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
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
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
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.
CHAIRMAN KASS: Thank you very much.
Richard Doerflinger, United States Conference of Catholic Bishops.
MR. 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
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
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
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
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
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.
CHAIRMAN KASS: Thank you very much. If you'd
give the documents to the staff table, we'll see that everybody receives
The last comment is from Susan Poland speaking as a private citizen. Ms.
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
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
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 —
CHAIRMAN 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
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.
CHAIRMAN 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
So that, then, you had a homogeneous cell line derived from this heterogeneous
cell line. So it in no way implies live birth.
CHAIRMAN 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?
CHAIRMAN 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
CHAIRMAN KASS: We'll make the request more precise,
and we might be in touch with you. Thank you very much.
MS. POLAND: Okay.
CHAIRMAN KASS: Robby George, and then —
DR. GEORGE: Yes. Can I ask Richard Doerflinger
CHAIRMAN KASS: Is Richard still here? Yes, please,
DR. 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?
MR. 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 —
DR. GEORGE: Yes, that answers it. Thank you.
CHAIRMAN KASS: Thank you very much.
Thank you all for your wonderful work, your endurance. The meeting is
(Whereupon, at 12:18 p.m., the proceedings in the foregoing matter were