Hilton, Crystal City 2399 Jefferson Davis
Highway Arlington, VA 22202
April 26, 2002
COUNCIL MEMBERS
PRESENT
Leon R.
Kass, M.D., Ph.D., Chairman American Enterprise
Institute
Rebecca S. Dresser, J.D. Washington University School of Law
Elizabeth H. Blackburn,
Ph.D. University of
California, San Francisco
Daniel W. Foster, M.D. University of Texas, Southwestern Medical School
Francis Fukuyama, Ph.D. Johns Hopkins University
Michael
S. Gazzaniga, Ph.D. Dartmouth College
Robert P.
George, D.Phil., J.D. Princeton University
Mary Ann Glendon, J.D.,
L.L.M Harvard University
Alfonso Gómez-Lobo,
Ph.D. Georgetown University
William B. Hurlbut, M.D. Stanford University
Charles Krauthammer,
M.D. Syndicated Columnist
William F. May, Ph.D. Southern Methodist University
Paul McHugh, M.D. Johns Hopkins Hospital
Gilbert C. Meilaender,
Ph.D. Valparaiso University
Janet D.
Rowley, M.D., D.Sc. The University of Chicago
Michael J. Sandel,
D.Phil. Harvard University
James Q. Wilson, Ph.D. University of California, Los Angeles
INDEX
Session 5:
Enhancement 1: Therapy vs. Enhancement
Session
6: Regulation 1: Regulatory Approaches to New
Biotechnologies
Session 7:
Public Comments
PROCEEDINGS
SESSION
5: ENHANCEMENT 1: 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 of cloning.
In the cloning case, the
public policy option at least on the table is one of legislative
prohibition, but the public policy options open to us in this field
are much broader, and we have yet to have that broader conversation
which we will do today.
On the other hand, if there is
continuity between the subjects of today there is discontinuity, if
not in the subject matter at least in our approach to it. Curiously
to at least this observer, the subject of cloning which first became
a hot topic several decades ago in the context of possible eugenic
possibilities of producing superior human beings or replicating them
now is taken up primarily over the -- as a matter of a new and
benign treatment for infertility in certain cases.
When we
take up the question of the possible implications of going down the
road of cloning for biomedical research, we think primarily of the
benignness of the ends of medical therapy and bracket to the side
other possible uses that might be made of the powers that are
available here.
And when we take up the ethical questions
there, the primary question has been about the ethics of the means,
which is to say, what happens to the embryos that are produced in
this -- in the research?
We have adopted generally a
case-by-case approach in thinking about these matters. It's
perfectly understandable because these technologies come to us one
by one. We are reluctant, at least some of us are reluctant, to look
too far ahead, partly because it's uncertain where things are going,
partly because we're practical-minded and don't want to engage in
speculation where there are clear practical issues before us.
And I sense that at least some members of the panel are
unwilling to allow -- unwilling is too strong -- are nervous of
allowing fears about future shock to imperil the present science.
And yet I want to suggest that the reason that maybe not -- the
reason that we are here not necessarily as individuals, but the
reason why the public is concerned about the kinds of questions that
give rise to the field of bioethics is -- and, therefore, too, in a
sense, the existence of a panel like this, is a real concern about
where biotechnology might be taking us in the large.
And as
Charles said at a previous meeting, his concern is less with where
these powers come from, but the uses to which they might be put. Not
only are we concerned, if we are concerned ethically, about the harm
to newborn children made of cloning, or about the embryos that might
be lost in the process, but about what we might do to ourselves and
to others when we start to use the powers biotechnology makes
available for purposes beyond the treatment of individuals with
specific diseases and disabilities.
The promise -- I think
the concern that is on people's minds is if you put it in the
extreme form, the promise, if you like it, or the horror of some
kind of super or trans or post-human future, where the prospects of
-- in the mouth of the proponents -- some kind of superhumanization
or improvement of the race or dehumanization if you worry about the
consequences is at issue.
And I think, as it's been said
before in the meetings, we somehow recognize whichever side we are
on the question of cloning for research that there are powers
available here and ideas that are afloat here that will affect what
it means to be a human being, not only from the technologies but
also from the underlying ideas.
And as it happens, this
morning's Washington Post, in the Style section, which indicates
where these things get taken up, there's a story on the next
generation where bio-cyborg, etcetera, man is introduced, and it
shows you what's happening. I mean, I have never, in 25 years of
being in a classroom, brought a newspaper -- bring some reference
of, you know, Rousseau or Tolstoy or something like that.
But here let me just say here are questions put before us
about the possibilities of changing our species, not because anybody
is heading deliberately to do it. But what would parents do when
offered something that would increase their child's SAT scores by
200 points? And I don't think he has in mind genetic engineering,
but certain pharmacological things of the sort we might talk about.
What will athletes do when they are encouraged by extreme
big-buck leagues to have medical pit crews? What will fat people do
when offered an implant that will monitor and alter their
metabolism? What will the military do when it can overcome the need
for sleep? What will the aging do when offered memory enhancers?
What will babyboomers do when it becomes obvious that Botox and
Viagra are just the tip of the iceberg for the pharmagenetic
sex-appeal industry?
Supposing technology allows us to
transcend seemingly impossible barriers, not only for ourselves but
exponentially for our children? What price does trans-human wisdom
and power demand?
Now, hyperbolic, journalistic we can I
think easily detach ourselves from this if we would like. But I
would suggest that it is I think incumbent on the Council at least
to explore the possibility that there is something here worthy of
our attention. And the question comes to us usually in this form.
What should we think about, and what should we do about the uses of
these powers when they go beyond the accepted medical norms of
healing disease and relieving suffering?
And what, if
anything, could be done about this, even assuming that we would like
to? Hence, the question about enhancement. Hence, the question about
regulation. I think this is a natural context for this.
The
question about the so-called brave, new world problem usually comes
to us in the somewhat tepid form of the distinction between
enhancement and therapy. Enhancement is a rather sanitized name
perhaps for what in the mouths of some people is a much more
grandiose hope and aspiration.
And I think Council members
have been sent a very interesting new book by Gregory Stock called
Redesigning Humanity. Stock is a physician, scientist, and
futurologist of sorts. He at least has the courage to lay out what
he thinks is coming for our consideration.
You don't have to
like his point of view on it, but I think it's a useful thing to
think about. It may be excessive. It may be not. But I'd be
interested in your reaction.
For this first session, we're
going to have a preliminary go-around on this topic of enhancement,
to ask ourselves whether this is a useful distinction therapy versus
enhancement, to see whether it matters to us, and then to try to do
so in the light of some concrete cases that have been put forth as
possible exemplars for consideration of this topic.
The
staff has prepared a working paper that you have in your briefing
books that, in fact, explores some of the ambiguities in the terms,
makes an argument as to why it still should matter to us whether
this is the right term or not, and then gives several examples.
And I would just simply like to open the floor for reaction
to the working paper and to this topic.
Paul? Paul McHugh?
DR. MCHUGH: Yes.
Well, you asked me if I wouldn't try to kick off something. First of
all, in the reaction to the working paper, I like the working paper.
It does develop ideas sufficiently far for us to carry on a coherent
conversation. It makes very useful distinctions in relationship to
certain aspects of therapy and enhancement.
What I miss from
it and from the other articles here is any understanding or any
clear description of just the several domains of therapy. Okay?
Before enhancement.
And you said, for example, Leon, to
begin that therapies can be construed easily if we think of healing
disease and relieving suffering. But the issue of what you call
disorder that comes to a doctor and particularly, by the way, to a
psychiatrist can have several distinct realms of enterprise and
distinct issues in relationship to disorder and health.
And
if you just looked at them in a simple order -- I don't want to
lecture you too much on this -- but I do think the important thing
before we talk about enhancement is we do know in what ways therapy
-- appropriate therapy is now available and is used by doctors and
everyone accepts these as therapies, even as they begin to merge on
the issue of enhancement.
First of all, a therapy for a
symptom or sign that can be tied to a structural or functional
abnormality of the body is therapy flat out. It is talking about
your disease issue. And that would be the therapies, for example,
for pain management or, as was nicely shown in the working paper on
dwarfism, a growth disorder in which you can show that the person's
sign, namely a lack of growth, is due to a lack of hormone. And the
replacement of that hormone is an appropriate treatment.
Now, by the way, with further advances in medical science,
more and more appropriate disorders that have a pathophysiological
basis related to a structural or functional abnormality will come
forward, we'll find more of them. But those are not the only
therapies that we work on.
For example, there is an
appropriate therapy for motivational drives that are strong enough
to overwhelm resistance and produce destructive behavior. For
example, gastric stapling for the obese and overeating. We think of
that as an appropriate treatment now, protecting people from the
obesity that brings it -- brings with it other disorders.
But there is appropriate treatment for the sleep disorders
like narcolepsy. And for those induced disorders such as nicotine
habit, we use Nicorette gum. And even with the paraphiliac disorders
we are now using Lupron and other things to reduce the sexual drive.
And we see them as appropriate therapies.
The third area is
therapy for the dispositional traits that hinder adaptation. And
here we begin perhaps to think in terms where enhancement comes into
play. But there is no question that Ritalin for the condition
attention deficit disorder has been useful. And we are still
exploring the place of Prozac in relationship to certain neurotic
tendencies and disorders.
And although my friend Peter
Kramer has talked about cosmetic pharmacotherapy, there probably are
psychological dispositions for which an appropriate treatment is
available. After all, by the way -- and it might not be a therapy --
but all of us use -- many of us use a compound that helps us to be a
little bit more talkative at parties. And one of them was used on me
last night, and I was probably a little too talkative.
(Laughter.)
And a little coffee to wake up.
But to go from dispositions -- to go from diseases to
motivate to drives to dispositions, and then there are therapies for
intense human emotional reactions to life stresses. And here you
might think in terms of enhancement, but antidepressants used for
people in the throes of serious and deep grief and even sometimes
sedatives for life tensions that are occasionally abused, but can be
justified in some patients.
It's after that that you come to
the cosmetic and health therapies -- cosmetic and health therapies,
again, that we wouldn't -- that begin to border on enhancement but,
gee, we wouldn't want to do without them for appropriate treatment.
I mean, after all, orthodontia is an appropriate cosmetic therapy,
but it also has health benefits. Facial, bodily cosmetic surgery,
again, you might wonder about them, but encouraging face lifts or
encouraging cosmetic facial surgery to help people I think is not
simply enhancement.
Viagra now -- it's got a bad press, but
it is a cosmetic or a health therapy that I think enhances life
circumstances in many cases. And then we come to the therapies on
demands that are pure enhancements. I want to be taller, stronger,
faster, brighter, and it's there that we really can see that the
enhancement issue comes into play.
I've had two encounters
with both -- with those things. One of them was a personal one when
I was a small person in Massachusetts, and somebody suggested to my
father I should have human growth hormone. And, fortunately, my
father said no. And if he had said yes, at that time those -- those
hormones carried with them in many cases Creutzfeldt-Jakob disorder,
as you know, afflicting people who later -- who grew but -- and my
father said he was small and I was going to be small, and it would
be all right.
(Laughter.)
And now I talk with you,
with the group, is, as you know, there are -- and these are -- these
would be enhancement issues, because I was not outside of the
envelope that Richard put nicely together.
The other one is
that with ADHD or the attention deficit disorder issue being clear
amongst young people, there are -- amongst the intensely interested
young people, interested in being sure that their SAT scores are
high, there are in a number of private schools minor, and sometimes
rather major, epidemics in Ritalin use as the Ritalin gets shared
around. And I've had several patients who have developed addictions
to the drug.
So my point only is that if we're going to talk
about enhancement let us be very sure that we know what therapy is
and just wrapping it up with the idea that there is -- that therapy
is for diseases and everything else would be enhancement might make
-- might close off opportunities to see just what doctors do for
benefits of patients.
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 being.
And it's in that area -- and I think I
mentioned this in the first meeting -- all of these traits involve
anywhere from 50 to 100 to 200 individual genes working together in
a highly regulated, concerted fashion to lead to somebody who is
very smart or very tall, or whatever.
We don't have a clue
about that. We probably are not going to have a clue about those
interactions, both positive and negative, for another 10 or 20
years. So I think that enhancement, in terms of somebody -- for
reproductive cloning is so far down the line that, again, that's not
an issue that we need to take up.
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."
(Laughter.)
But that's over now.
(Laughter.)
I agree
with you that we ought to concentrate on the here and now, and that
means one-shot enhancement versus germ line enhancement. But I'm not
sure that one-shot enhancement -- I mean, the kinds of things that
Dr. McHugh was talking about, are that much unrelated to the age-old
enhancement of alcohol.
I mean, we have a paradigm for
dealing with enhancement. It's not exactly a new problem. It's got
new dimensions. I think what is new is the prospect it could be a
decade or two or more away of -- germ line enhancement -- of
changing us permanently. And as a Commission with a wide mandate,
I'd like -- I'd hope that we could discuss that also. We probably
would be the first to think about it officially. We might contribute
to people's thinking about it when it becomes more imminent.
And one of the reasons it's important, as Professor Glendon
mentioned, there is a question of economics. There's a deep question
of, as opposed to international inequality, of national inequality.
If we are going to have permanent enhancements of a similar kind to
germ line enhancements, it is overwhelmingly likely that it'll be
the rich and that those well-positioned who will have access, and
what that does is it changes a society with shifting inequalities to
a society of permanent inequalities.
And that I think is a
deep social issue which will really challenge us in the future. And
even though it is in the future, I think it's worth us thinking
about now as a way to contribute to people thinking about it when it
actually becomes imminent.
CHAIRMAN
KASS: Thanks, Charles.
Gil Meilaender?
PROF. MEILAENDER:
Yes. I just wanted to think a little bit about where Paul started
us, because I really do think if we're going to try to say anything
about this, or even just talk about it, it's very puzzling.
If we start at the furthermost reaches of Paul's set of
possibilities -- I mean, people don't just want to -- they don't
just say they want to be taller, stronger, brighter. I want to be
those things because I'm not happy right now. You know? I'm just not
happy with my place in the world. Or maybe if I have taken a
philosophy course, I'm feeling alienated even.
So the -- if
we're not able to make some kind of therapy enhancement distinction,
we're not going to know or we're not going to have any sense of kind
of what it would be appropriate for a doctor to decline to do, what
it would be appropriate to think that somebody -- some third party
should fund, what it would be appropriate to regulate or not
regulate.
And, I mean, Paul presented a series of steps, but
I don't think there's any reason to think that what I counted as
number 6 in it, you know, has thus far been demonstrated to be
enhancement as opposed to therapy.
Now, I think it is, in
fact, but one needs an argument more clearly spelled out. And even
going farther up, you know, the emotional reactions to life
stresses, well, there are a lot of religious thinkers who think that
life is always stressful, and that it's not actually wrong to feel
alienated in the universe. After all, one needs a certain kind of
answers to those questions.
That's not necessarily a medical
problem. That might be really keen insight into the nature of
things.
So this is just -- I mean, this is not to provide an
answer but to say that I don't think there is any progress to be
made in thinking about the question if somehow or other we don't
really clarify that issue, not just talk about it but actually try
to clarify for ourselves what it is.
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 to enhancement.
And in order to draw the distinction, even if that's the
underlying moral worry, we are going to have to try to work out some
account of what normal human flourishing is, or health, and that
might be that account which isn't an easy matter to articulate. That
kind of account would have to provide reasons to restrain the drive
to self-mastery and self-perfection that may underlie -- may animate
the drive to enhancement and perfection, and that we would want to
reign in.
I would also -- so I think that's the fundamental
moral issue that we're going to -- and I think we should try to take
it up, and others may have different ways of accounting for what
troubles us about enhancement. But I would just also want to add
support to Mary Ann's proposal that we include in these discussions
the economic dimension.
Now, there is a certain paradox in
having these two discussions, because on the one hand we're saying
these various techniques of enhancement are deeply dehumanizing
properly understood. And then, with another part of ourselves we
say, and, by the way, we also worry that these dehumanizing
technologies will only be available to the rich, and that's unfair.
(Laughter.)
So I think there is that paradox. But I
don't think the fact that it's paradoxical should lead us to shrink
from either part of that discussion, because I think there is
something troubling on both poles of that paradox.
DR. KRAUTHAMMER: Ice cream is
equally dehumanizing, but everybody wants it.
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.
(Laughter.)
That's the trouble
with conversation. You really want to continue it, but there's a
queue. Dan?
DR.
FOSTER: I only want to make one -- by the way, I
agree with the issues of justice and the other things that have been
said, and I certainly think -- and I've already told Leon, I think
we clearly have to discuss the issue of germ line therapy.
And, by the way, even when you do somatic gene therapy, it's
now clear that there's a danger of leak into the gonads. I mean, for
the genes that you put into the muscle, there's a clear-cut risk of
overflow into the germ cells. So we have to be careful about that.
I only wanted to say in terms of life enhancement and
extension of life that -- particularly extension of life that Bill
spoke about, we know pretty well already how one can extend healthy
life from Drosophila through -- not absolutely proven in humans, but
indirectly, and that is to undereat.
There is no doubt -- it
was first shown in rats by Donald Massoro 25 years ago at the NIH,
that if you semi-starve rats that you increase their lives 20 to 30
-- now, if you starve a fruit fly, it's very interesting. This was
done and people didn't understand why the flies were living for a
long time. Not only did they live, but they were reproductive late
into life. They continued to be able to reproduce.
And the
key gene involved with that -- these gene people always give these
cute names to them -- it's called INDY. I'm Not Dead Yet. That's the
INDY gene --
(Laughter.)
-- in the fly. You know,
it's just like Tin Man gene in heart development. The Tin Man had no
heart, and if this gene is mutated you don't get a heart, you know,
so they -- so there are things that we can do without any
biotechnology or anything else just by healthy things that would
allow us presumably to live long. We don't know whether the dementia
would be impaired or things of that sort.
You have to be
careful, because I get challenged about this sometimes. If you
measure the body mass index, which is what everybody uses for
obesity and weight, it's just the weight adjusted for height. And a
normal body mass index is 25, and obesity is at 27 in this country,
30 in the world. It's a J-shaped curve of excess mortality.
So, in other words, as you go above -- as you get more and
more obese, then it's a logarithmic increase in deaths from
everything from colon cancer to diabetes, and so forth. But it's a
J-shaped curve, so if you're BMI is very low, that you have an
excess mortality as well. Those are sick people. Those are people
with restricting anorexia nervosa, where you have sudden death, or
cancer, and so forth. So don't be misled by that J-shaped curve.
That's a pathologic -- the short curve on that is pathologic.
So my point is that there are an awful lot of things that we
could do -- we can do to "enhance life" by just being healthy, and I
just wanted to make that point.
CHAIRMAN KASS: Thank you.
Frank, Rebecca.
PROF.
FUKUYAMA: I wanted to respond to something that
Janet said, and then to ask Paul a question. I really think that the
whole question of germ line engineering is one that we have to
address. I think that -- and, in fact, the complexity of genetic
causation is actually one of the reasons that we have to address it,
because the simple fact that we're not going to understand that
complexity in its fullness is I think one of the reasons that it's
dangerous.
I don't think that's going to stop people from,
you know, going ahead and doing experiments on animals in which they
modify, you know, one gene and it produces an effect, and then they
will try to, you know, reproduce that in humans. And I think what's
really problematic about that is precisely because that causality is
so complex that it's not like approving a new drug -- you know, the
FDA approving a new drug where you have a certain set of side
effects you're looking for.
I mean, the side effects of that
kind of intervention could be, you know, things that don't show up
until the -- you know, the subject is 60 years old. I mean, they may
be very subtle. It may upset all sorts of different kinds of
balance.
So it's -- I think that, you know, inherently
there's got to be a different, you know, standard for approving
that. But that -- simply the fact that it's complex is not going to,
you know, stop development in that area. And, therefore, I think it
is something we need to look at.
My question for Paul is it
really does seem that psychiatry is a really different domain. And,
for example, I don't really understand the process by which things
get entered into the DSM as disorders, because it seems to me that
that's basically a political negotiation more than a scientific one.
But I wondered if you could -- because in other areas of
medicine I think there are things that people pretty much agree are
pathologies, and there's good reason -- there's an etiology, and so
forth. But in psychiatry, that's not true.
DR. MCHUGH: For some
psychiatrists it's not true. I'd put it to you that way. I think
DSM-IV is the ultimate extension of a problem that we solved -- we
tried to solve 20 years ago, and it's now a problem in itself,
demonstrating that the problems of today are due to the solutions of
yesterday.
Let me just make that clear. In the 1970s,
psychiatrists couldn't do research, really, because they couldn't
agree on what was, for example, schizophrenia. You're called
schizophrenia in Baltimore; you'd be called manic depression or
maybe panic anxiety in San Diego.
The DSM process was to try
to give us a common nomenclature with the idea that we would become
more reliable. And, therefore, if I said I did research on
schizophrenia and had these results in Baltimore, it would be
replicable in Boston as they were trying to find reliability.
But DSM-IV and DSM-III are really a nomenclature that could
as easily be organized alphabetically as it could any other way. And
now we are really troubled by two things in it. One, that it's
drifting away from medicine. We are inventing more and more diseases
or disorders in DSM-IV, such that it's expanding exponentially.
There are now 2,000 different forms of depression that you could
figure out from that book.
And there are also conditions
that are invented that are in that book. You have to just get a
group of psychiatrists together, and if they say something exists
they can put it in the book. I'm surprised -- you know, I'm happily
surprised that witches aren't in the book. There are criteria for
finding a witch, after all, but we had that trouble before. So --
CHAIRMAN KASS:
That's not a disorder anymore.
DR.
MCHUGH: Excuse me?
CHAIRMAN KASS: I said that's not
a disorder anymore.
(Laughter.)
DR. MCHUGH: That's not a disorder
anymore, but it's operationalized.
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.
(Laughter.)
Massachusetts
has a lot to answer for.
(Laughter.)
The future
right now, in my opinion -- this is a side issue, but it relates to
what we're talking about. Psychiatry has to move in a direction of
more and more valid conditions that relate to certain kinds of
underpinnings that relate to the brain or to other clear human
disorders.
And we have not done that, and I think the next
10 years is going to be very interesting in the developing of DSM-V.
If DSM-V is identical, or just an extension of DSM-IV, that will be
a disaster for this discipline.
DR.
KRAUTHAMMER: Could I add a cul-de-sac on that
diversion? I worked on DSM-III in the '70s, particularly with Jerry
Clerman on the depressive disorders. And you're right, Frank.
There's a lot of politics in it in the end. It was -- as was pointed
out; it was a serious attempt to systematize nosology and to get
sort of a reproducible list of symptoms and signs that would model
what happens in the rest of medicine.
But in the end, of
course, it's politics, unlike -- I suppose unlike the criteria for
Type 1 diabetes. The criteria for major depression are negotiable,
so you negotiate them; you end up with a consensus.
The one
virtue is that you establish a preliminary consensus in DSM-III, and
then you spend a decade seeing if empirically it separates patients
into groups that are therapeutically useful. And that's how over
time you eliminate the politics. But as of now, there's a lot of
politics in the negotiations.
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 that
belief?
PROF.
DRESSER: Mike?
DR.
GAZZANIGA: Well, I want to take credit for having
paid for two of Paul's two-shot enhancers last night --
(Laughter.)
-- leading to his eloquent opening
remarks that really paint a picture. I thought I'd follow up and
just get off the germ thing and the clones and the embryos and talk
about some of the other gadgets that are around, because I think
this is one of the concerns that sort of comes out in the paper, and
so forth.
So, in the sphere of high-tech possible aids that
are coming down the pike, now being worked on diligently to -- for
therapy of spinal cord injury, there are people that are working on
devices that can somehow read the electrophysiological state of the
motor cortex and interpret it through mathematical algorithms that
somehow figure out what the motor cortex is trying to say to the
spinal cord, and then to physically jump over the lesion the person
has at whatever level, plug in the electrodes below the lesion, and
by thinking as it were their way through the movement, energize the
neurons below the cut and thereby giving rise to mobility.
Now that's a -- we're nowhere near there, but there are
very, very clever people working hard at this and making advances.
Slow, hard advances, I might add, but it's something that's in the
tube.
Now, what then comes along is other research that
shows that maybe there is some way you can read the desire to figure
out what two plus two is by reading your brainwaves and then access
this through some artifact that you might have on the side of your
head that actually solves the problem for you.
So instead of
you struggling with your multiplication tables or your -- whatever,
this device picks up the essential brain circuitries, pattern of
activity, sends it over to this machine, the machine says, oh, he's
trying to figure out this problem, the machine figures it out, sends
it back to your brain, and the kid raises his hand right as the
button -- I got the answer before everybody else in the class.
That, too, is a dream at this point. It's talked about,
written about, but no one really quite takes it seriously yet. But
you can -- the way that could work certainly is in the thought
processes of some.
But I think this feeds back immediately
to the -- so there are these things. There are these whole other
area of technological developments that the world is going to be
hearing about in the press way before it gets solidly built up in
the scientific literature.
But, of course, I'm kind of of
the view that there isn't a thing that our human species doesn't
adapt to once they think about it and absorb into its evolutionary
sequence. And we have these enhancements all over the place. The
kids now take their graphic calculator in to take the SAT test, and
that didn't -- that wasn't allowed a few years ago.
So there
are environmental enhancers. You can go take the Kaplan test and
pretty much bump your score up a couple hundred points if you work
hard on it. And all of these things -- and I don't think that a
reasonable group of people, certainly those of us involved in higher
education, see those things as relevant, particularly relevant
variables, because what you want to do in science is try to identify
the student that is creative, insightful, sees a problem in a way
that everybody else in the lab doesn't see it.
And once they
have an insight and then do the experiment, all of this sort of
elevated notion of being higher on an SAT is just part of the data
analysis. And the data analysis is -- while it seems opaque and hard
to do when you don't know anything about it, that's the easiest part
of a scientific exchange is coming up with the idea and the insight
on how to proceed is the challenge. And I don't think anybody has a
clue about what sort of gene manipulation encourages that kind of
thing. It's a rare, rare thing to see.
And, finally, to
return to the germ line issue, which is obviously an important
issue, there are many -- I think the Council would be well advised
to have, as we did yesterday, two leaders of this come in. There are
certain major molecular biologists -- Eric Lander comes to mind at
MIT, who is totally against any germ line manipulation, and there
are other biologists -- I can't think of one right now, who would be
the best for promoting it.
But there is major thinking going
on in the major intellectual centers on this point, and I think we'd
be well informed to hear about them before we go too far in thinking
about it from an ethical point of view.
CHAIRMAN KASS: Michael, thank
you.
Michael Sandel?
PROF.
SANDEL: I wanted to go back to the moral questions
associated with the allocation of resources that Mary Ann raised.
And I think this is an issue whether we're in the realm of
pharmacological or surgical or genetic interventions for
enhancement.
There are a couple of ways one could imagine
dealing with this problem. One of them struck me when a year or two
ago I read an article about a cure for wrinkles, some kind of
wrinkle remover that was produced by a cosmetics company and
extremely successful financially.
And it turned out that the
compound used in the wrinkle treatment if just slightly reformulated
was also a cure for sleeping sickness. And the company agreed to
work with a foundation and to make available for free through its
production facilities this slightly reformulated version of the
wrinkle cream which it could produce in massive amounts because of
the huge market for enhancement to cure a disease which was far more
morally significant but which would never have been invested in had
that been the only reason.
When I read about this, I didn't
know whether to be heartened or distressed, heartened that it was a
creative solution to the problem, the distress that sleeping
sickness and similar morally pressing diseases are only attended to
insofar as they happen to coincide with a cure for wrinkles, and so
that -- insofar as there are those opportunities, that would be one
way of dealing with the problem.
But I want to go back to
the face lifts that Paul raised -- low-tech enhancement -- and to I
think -- the germ line questions force our attention to existing
practices that may be morally questionable. And as for the face
lifts, surgical or through this Botox, it seems to me -- well, I'm
not sure, Paul, where you put it on your list, but I take it you
don't admire it. It's not something you find morally admirable --
the purely cosmetic face lift.
One way we might deal with
that -- and Janet is worried about excessive regulation. We wouldn't
need -- if we found -- of course, in all these cases, if we find
something morally troubling it's a further question what the law
should do or what regulation should do.
But if we agree that
face lifts, for example, are not morally admirable, but yet they
don't pose such a grave problem that they should be legally banned,
what we might do with them is what we do with alcohol. We can impose
a sin tax. We could consider that face lifts are not a crime but a
sin, and, therefore, they should be subject to a sin tax, the
revenues of which should go toward the health, or the restoring to
health in the case of things like sleeping sickness and malaria that
wouldn't otherwise get the resources. That's a modest proposal.
DR. MCHUGH: Can I
just say what I do think about face-lifts?
(Laughter.)
It's all in this area of facial cosmetics, which go from
treatments that I think we would be very happy to offer anybody to
ones that we think that vanity is being served. And there is no -- I
don't see a good, clear line, because, again, orthodontia could be
put into that, too.
Lots of people who were poor when they
were children and couldn't have orthodontia and are still unhappy
about their teeth get it in their forties and fifties. I had a
secretary who, fortunately, got some -- she began -- I would hate to
tax her for that, because she was always very distressed about her
teeth.
PROF.
SANDEL: Orthodontia is not a sin in the way face
lifts are, insofar as it does have some relation to health, even
though, you know, it may be marginal.
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 they've unfolded.
I mentioned the first day the issue of contraception, and
here I don't bring it up to judge it, just to say that it was a kind
of alteration of our natural reality that slipped in along the
gradient of apparent human good, or at least a desire, that went --
came in fairly unquestioned at the time, had a significant impact on
altering our personal lives and our social existence, and now we're
slowly getting a perspective on it.
But this brings me to
what I really wanted to mention. That is that at the foundation of
this whole question of enhancement are deeper philosophical, almost
religious questions about, what is nature, and what kind of a mind
has this world produced in the creatures that now have the power to
govern nature?
Einstein said that the most incomprehensible
thing about the world is that it's comprehensible. That's -- I think
he meant mathematically, but the question is whether it's morally
comprehensible in the sense that we understand ourselves. It's clear
that we live and will use our new powers along the gradients of our
desires, but within the natural mind it seems to me that desires
function as impulses toward a direction, not necessarily a
destination as such.
So that if desires, like, for example,
the desire to eat that Dan was just speaking of, it may be good for
you ultimately to eat less, but in our environment of evolution and
adaptation we developed a strong tendency to want to eat more. And
so now that we have refrigerators we basically have at our hands
more than it's good for us to eat. And so now we have an epidemic of
obesity.
So that seems to me to be a fundamental issue. We
have to figure out how we relate to nature, what is good within the
order of nature, and it's going to take not just scientific
knowledge but a kind of self-knowledge of what's driving the force
that would produce the gradients along which we would move toward
our enhancements.
Does that make sense?
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.
(Laughter.)
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 altogether coherent.
First of all,
I think we all recognize that there is continuity here with no
lines, which makes this very difficult. The people who trot into
this discussion by saying enhancement versus therapy haven't thought
enough about it, because the area -- nevertheless, that there is a
twilight doesn't mean that at a certain point you know that it's day
and at a certain point that you know that it's night.
And
it's incumbent upon us if we think that there is some distinction
here, however fuzzy the boundary is, that's worth making -- it seems
to me it's worth struggling to try to clarify what it is that is at
stake and what it is that -- how we might evaluate it. That would be
point number one.
And I think this point has been made by
others, but the fact that there is already precedent -- that was in
a way the part -- the force of Michael Sandel's question to you,
Paul. The fact that certain sorts of things are already accepted,
and, therefore, might serve as precedent for the next step cuts in
two directions.
We might reevaluate where it is we have gone
and see it only in the light of hindsight. And the fact that there
are environmental kinds of enhancements may or may not be
precedent-setting for what to think about enhancements written into
the human body or mind, whether reversible or not.
I'm not
begging the question. I'm simply raising it. We came to this before
when one wondered about, what's the difference between
bioengineering and social engineering? And does it have a kind of
different moral character for us to consider?
Third comment
-- and that has to do with I think it's very -- it has to do with
the business about inequality and justice. And my response to
Michael's very astute observation is to say it's very easy I think
for us to treat this question in terms of the distributive justice
question and to also recognize what a precious -- what preciousness
there is to be sitting talking about these sorts of things when
there are really much more profound human concerns and questions
about the uses of our resources, and so on.
But I think we
would do ourselves a disservice if we immediately said, look, the
real problem here is that some will have and some will not. I think
the first question is whether the thing which is sought for is, in
fact, desirable because there will be a great deal of pressure to
have what this is, if, in fact, it turns out to be good. And all
you'd have to do would be to take a look at the example of the
Ritalin use for improved test results.
Let's assume for the
moment that there is something like this which actually improves
attention span and people get wind of it. The pressure, even on the
people who have no interest in using it, is comparable to the
pressure that is now available to extra tutoring and extra -- those
sorts of things.
So that even if it -- we don't -- even if
we leave these matters to free, private choice, the social pressure
in the direction of using these various kinds of enhancements, at
least in this community, would be considerable. So I think it's
rather important for us to try to look -- to not start with the
question of inequality or distribution, but to look at the question
of the enhancement itself, or the alleged enhancement itself, and
see what one thinks about it and what its human costs might be,
assuming that the blessings of it could flow to everybody. Okay?
Now, maybe we could make some progress on this if we took
one of the examples here that's been put before us by the staff for
discussion. And I don't know which of them would be most fruitful,
but --
PROF.
FUKUYAMA: Leon?
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 from this?
PROF. FUKUYAMA: Well, what I draw
from this is that you see -- you hear a lot of discussions, like the
one we've had this morning, in which people quite rightly say, oh,
it's very hard to draw a distinction between therapy and enhancement
and give lots of examples why that's the case. And the conclusion
they draw from that is, therefore, let's not even try to, you know,
make that boundary as a practical matter.
And all I'm saying
is I don't -- I mean, I'm sure there are a lot of cases where it's
going to be very difficult to draw that boundary as a practical
issue. But we shouldn't give up on trying to design institutions
that can maintain that distinction on the basis of a theoretical
puzzlement about, you know, where that boundary, you know, precisely
can be drawn.
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 way.
But much of
what we've talked about this morning, these distant, remote -- as
Janet Rowley put it out -- possibilities for doing X, Y, and Z, I
don't think we can draw any political or regulatory implications
from these statements at all.
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?
(Laughter.)
DR. GAZZANIGA: It goes on for
months, and he finally calls up Paul and he says, "Paul, I've got
this problem."
(Laughter.)
"Around 2:00 to 4:00,
5:00, every afternoon, I have lassitude. I just, you know, I just
can't concentrate." And Paul says, "You know, I can fix that. I can
fix that. We'll just pop a little Ritalin in there, and you'll just
get through 2:00 to 5:00, and you will be -- continue your high
level of productivity for these highly moral questions you're
working on."
(Laughter.)
Would you take it?
CHAIRMAN KASS: I've
been to see him.
(Laughter.)
DR. MCHUGH: I wouldn't prescribe
it, but how many --
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 quite sick.
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.
(Laughter.)
No, I understand. And I think you've put it very nicely,
because it seems to me that some of these kinds of things -- that
would be a perfect one -- would be not so much an intervention that
would produce a certain result, but would be an intervention that
might make me much more fit to be who I am alertly. Right?
DR. KRAUTHAMMER:
But what --
CHAIRMAN
KASS: I'd just -- I mean, to be is to be awake. And
if I am flagging, then all kinds of human possibilities are
imperiled.
DR.
KRAUTHAMMER: But what if his problem is not
wakedness but he wants distraction and a bit of a buzz? Isn't this
the same question as, why do we not allow people to take marijuana
if they want to achieve "happiness" that way? I mean, we have
decided as a society that's not a good idea. Is that that different
a question?
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 --
(Laughter.)
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
--
(Laughter.)
-- that disclaimer, isn't it?
PROF. MEILAENDER:
Well, I was making it on your behalf.
(Laughter.)
Sorry. But -- and this is by no means a full solution to the
problem. I don't mean it in that way at all. I mean, I don't think
it gets us off the hook for thinking about the therapy enhancement
distinction or anything like that.
But if you think about
the thing that Michael raised, we would have far less to fear from
these matters if we were better people. And, I mean, there should be
some way to say that without just sounding moralistic. In other
words, if you're going to bed at 2:00 and getting up at 6:00 because
you think the bioethical future of the country rests on what you do,
well, then, let's think about that and a virtue like humility, for
instance.
(Laughter.)
If you fear for the future if
this Council doesn't accomplish some of the good -- well, let's
think about virtues like hope or courage, you know. And as I said, I
don't know how to --
CHAIRMAN
KASS: Do they come in a bottle?
(Laughter.)
PROF. MEILAENDER:
Well, no, they don't, in fact. And we would have less to fear about
these questions, or even about Paul, on one particular occasion,
maybe giving you -- prescribing the Ritalin if we were better people
in a way. Now, that doesn't solve the problem. We're not going to
become better people just all of a sudden.
But I think in
some way it wouldn't be a complete thinking through of the issue if
we didn't take account of that.
CHAIRMAN KASS: Would someone like
to join that?
DR.
MCHUGH: I'd like to join that and agree with it.
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 --
(Laughter.)
-- what a
wonderful kid this is. Okay? So that very often I avoid this process
of offering medication by talking to people about the meaning of
what they're doing, how they are doing it, offering them alternative
ways of looking at what they're doing, and some of them are pleased.
(Laughter.)
I emphasize some because --
(Laughter.)
-- there are quite a few who go and find
another doctor to do exactly what they want done.
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 end.
And
so somehow we need -- I think behind this whole question is a deep
question of nature, a deep question of the degree to which we know
what is good in nature, and how much we dare to intervene to promote
what we think on the surface is what our lives are about and perhaps
then miss the thing that they're really about.
I said the
first day -- I promise this is the last time I'll say this, Leon --
but I think we could put ourselves in danger of walking ourselves
right off the stage of the drama of our deepest significance.
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 or not.
And part of what's at stake there I think is -- and I'm not
sure that -- Bill, that this would be a way that you would -- a
reformulation of the point you're making. That would be friendly.
But it does seem to me that thinking about the question of
better and worse uses or admirable or less admirable uses or
unadmirable uses or degrading uses is some kind of notion explicit
-- tacit if not explicit -- of what it would mean actually to
conduce to human flourishing and our fulfillment, which is not a
simple matter and it's not for governmental commissions to settle.
But at least we can be mindful of the fact that some tacit answer to
that question is somehow implied in how one thinks through what
norms are we to use when we're not engaged in the business of
healing or assisting.
So let -- Michael, please.
PROF. SANDEL: Could
I just add, along these lines, as I've heard this discussion, I
think that however we came at it there is real enthusiasm for
exploring the human and the moral implications of enhancements or of
-- or going beyond aiming at perfection.
And if I could just
add a small correction. Before when you chastised those of us who
raised the moral questions of allocation for putting that ahead of
the underlying moral questions of enhancement, I didn't hear any of
that. I didn't hear any suggestion that that should somehow
substitute or preempt a discussion of the human consequences and the
moral consequences of aiming at perfection. I thought that had been
emphasized by everyone who spoke, and I hope that we take that up.
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 thank you.
Charles,
do you want a word? And then we should stop.
DR. KRAUTHAMMER: Yes. Just one
word and a caution. I think as we think about this it's important
for us to understand how our discussion will differ from the
decades-long debate that the country has had on recreational drugs,
which is a sort of paradigm I think of this question. So what are we
contributing?
I mean, obviously, we'll be looking at other
aspects of this. But fundamentally, I 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 of.
DR. KRAUTHAMMER: Well, that's
precisely where I think we ought to focus, because otherwise we
would be recreating an old debate.
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 1:
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 in.
Since I mentioned it in the
first meeting and Frank prepared the -- a short memo at our request,
Frank, do you want to say something further about it to get started?
We've had a couple other people prepare to lead off in response, but
would you like to just hit a couple of high points?
PROF. FUKUYAMA: Sure.
CHAIRMAN KASS: And
then, we'll take it from there.
PROF. FUKUYAMA: Yes. Well, I --
you know, I must say I begin this not as any fan of regulation, but
I do think it's worthwhile considering whether we need to think
about a new set of institutions to regulate biotechnology.
Now there are a couple of I guess precedents for this. One
is, you know, something like the Interstate Commerce Commission that
Jim Wilson mentioned. Actually, I appreciate this idea that you
shouldn't create institutions in the absence of real problems. I
actually think that we have real problems that such an institution
would address.
But it seems to me that a lot of Jim's
examples actually -- I'm not sure which direction they point to,
because they were all cases in which you had established regulatory
agencies that had to deal with a new technology and try to
incorporate, you know, that into a preexisting regulatory structure.
So trucks into a system that had been designed to regulate
railroads or, you know, satellite television into a system that had
been designed to regulate, you know, land-based telephones. And the
question is whether we aren't at such a juncture.
And, in
fact, if you look at the FAA -- you know, when airplanes came along,
people decided that this was a sufficiently different technology
that they didn't give it to the Interstate Commerce Commission,
which was an option, you know, that was available at the time.
And so now in agricultural biotechnology, the Reagan
administration actually had a series of meetings in the 1980s to
decide whether the new, you know, recombinant DNA technology was
sufficiently different that it required a new regulatory structure.
And the result of that, they decided they were going to regulate on
the basis of product, not process.
It wasn't sufficiently
different, and I think that was a -- you know, a perfectly
defensible decision on their part. And so right now agricultural
biotechnology is regulated by the Agriculture Department, the FDA,
and the EPA.
I think that there are a number of reasons that
I outlined in the memo for thinking that, you know, we're going to
face a lot of problems that Congress should not have to intervene
on. I mean, there are just going to be too many decisions that will
have to be made for Congress to intervene the way it is intervening
on the question of human cloning, which means some delegation of
decision-making authority to another agency.
Besides the
ones I listed in the memo, if you just think about the issues we
talked about yesterday having to do with stem cells and the
treatment of embryos, you know, one clear approach to -- that would
satisfy, for example, a lot of the concerns I have about cloning and
embryos would be to establish a clear-cut regulatory structure for
experimentation on embryos.
So that, for example, the line
of questioning that Bill started, you know, that right now we want
to do things to embryos that aren't older than 14 days, but
supposing down the road someone will decide that you actually need
to do something to fetuses, you know, one way of solving that -- I
mean, if your real worry in the short term is that slippery slope,
then clearly one solution to that is to set up a regulatory
structure that would cut things off at 14 days and say, no, you
cannot -- you know, we're going to permit cloning or stem cell
research up to this point but not further, and put a break on that
particular slope.
And there's actually a model out there,
which is this Human Fertilization and Embryology Agency, in Britain
that does that, that regulates embryo research. It regulates their
IVF industry and establishes these kinds of rules for, you know,
that sort of experimentation. And they've already done it. In fact,
it's a 10-year old agency.
And I think that, you know, I
personally do not have any concrete ideas about, you know, what the
institutional design for such an agency or -- you know, first of
all, I'm not wedded to the fact that we need a new agency. I think
simply that we need to think about it, but -- and I'm not wedded,
certainly, to any particular institutional design.
But I do
think that it is an issue that we need to look at very concretely,
because there really are holes in the current structure. I mean, the
one -- the biggest hole really has to do with the whole, you know,
private sector and the whole private, you know, biotech industry,
which does not fall under the NIH's rulemaking power, which,
incidentally, the British law, you know, fixes.
There is no
such distinction between public and private in the British
regulatory system. And that's a problem that comes up with -- you
know, with an agency like the RAC, the Recombinant DNA Advisory
Committee.
Janet and I were talking about this over
breakfast. I think that that was an exemplary, you know, instance of
self-regulation by scientists, and it worked -- you know, is a
system that worked, you know, quite well in its inception.
My understanding is that a lot of people that work with it
now think that the industry and the -- you know, the structure of
scientific research in the United States at this point has outgrown
that particular structure, because there is so much that's now done,
you know, in the private sector.
Now, I don't necessarily
believe that -- I'm not trying to argue that we need more formal
regulation or that self-regulation is impossible. I just think that,
you know, it's a serious set of issues that -- you know, that
deserve to be looked at.
So let's -- all right. Let me just
stop there.
CHAIRMAN
KASS: Thank you very much.
I have asked
Rebecca Dresser to open up response with -- after Frank's
introduction. Please.
PROF.
DRESSER: First, I'd like to commend Frank for his
cogent and articulate case in favor of a more systematic approach to
regulating biotechnology. In calling for added oversight, he really
joins a number of other scholars and advisory groups addressing
bioethics issues.
For example, in 1995, Dr. Jay Katz, a
respected medical ethicist, called on the government to create a
national board authorized to regulate all research involving human
subjects, including funded by the private sector. The board, in his
proposal, would consider big picture questions that are too broad
and complex for institutional review boards to evaluate.
Others have made similar proposals contending that a
national board is needed to review proposals for research that could
affect the human germ line, research on xenografts, research on
certain assisted reproduction methods, and experimental attempts to
create human-animal hybrids.
Fukuyama writes -- and this is
a quote -- "Deciding where precisely we should draw lines concerning
technologies that have not yet come into being is not a fruitful
exercise at this point. It's less important at this point to make up
a definitive list of restrictions than to think about general
principles that should govern the development and use of
biotechnology and to begin designing institutions that will enable
us to make critical decisions in the future."
I agree with
this, but I do want to emphasize the challenges that are in here and
the effort to settle on even general principles and institutional
design.
Difficulties in carrying out these tasks are a major
reason why the earlier proposals I mentioned have failed to produce
national oversight systems. Let me give you a couple of examples. In
the 1970s, Department of Health, Education, and Welfare created an
Ethics Advisory Board to determine whether the Federal Government
should fund research on in vitro fertilization and early human
development.
The Board was given the responsibility to
review each proposal seeking government funds. So it reviewed the
topic and made general recommendations about the criteria that
should govern federal funding. But then, its charter lapsed in 1980,
and it wasn't renewed. And then throughout different administrations
the Department of Health and Human Services Secretaries, nobody
would pick this up off the desk and would appoint another Ethics
Advisory Board.
So most people looking at this attributed
the inaction to politics, controversy surrounding the status of
developing human life, produced a reluctance to adopt explicit
government policy on IVF research. As a result, the Federal
Government failed to engage in oversight of research related to
assisted reproduction, and this is what led to our current situation
in which such research is supported by private funds, subject only
to voluntary guidelines prepared by professional organizations and
by the researcher's personal ethical beliefs.
A more recent
example of the difficulties in establishing even general principles
and oversight mechanisms concerns research involving people with
dementia and other mental disorders that may affect decision-making
capacity.
Many people think that current U.S. regulations
are inadequate to resolve the ethical issues that may arise in
research involving this population. In 1998, our predecessor, the
National Bioethics Advisory Commission, produced an extensive report
and recommendations including recommendations that the Secretary of
DHHS appoint a national special standing panel to review certain
ethically controversial proposals and supply guidance to IRBs
reviewing studies involving this population.
After that,
though, some psychiatric researchers spoke out against this
recommendation, claiming that it would impede the search for
treatments to help people with mental illnesses.
And because
of disagreement, then, about substantive principles, such as the
degree of risk that's acceptable in research involving people who
have impaired decision-making capacity, and disagreement about the
structure of oversight, whether it should be national or whether
local IRBs were sufficient, because of these disagreements the DHHS
has not created this special standing panel.
So I think we
cannot underestimate the barriers to moving forward. So then, how do
we begin the task of developing general principles and designing
institutions that would apply them?
Well, first, I do think
existing institutions could apply existing principles in ways that
would address some of the moral issues that biotechnology raises.
As pointed out in our cloning discussions, current U.S.
regulations say that risks to human research participants must be
reasonable in relation to expected benefits, either to participants
if there are any, or to the importance of the knowledge that the
study will produce.
So the regulations incorporate this idea
of justified risk to subjects. And I think this requirement to
determine whether a study will generate information that is
important enough to justify exposing study participants to risks
offers an opportunity for IRBs to evaluate whether, for example, an
experimental intervention that could increase a child's height
offers a significant enough benefit to justify exposing children to
physical, emotional, and social burdens in the study process.
This offers a mechanism for determining whether the
potential benefits available through experimental interventions on
what many of us would view as enhancements warrant exposing children
to the risks present in the testing process.
FDA regulations
that exist now also offer related opportunities. The FDA does
require all private research sponsors seeking to test drugs,
devices, and biologics to have their studies reviewed by IRBs before
there is any human exposure. And the regulations direct IRBs to
evaluate, again, whether the risks presented in -- by an
investigative drug or device are reasonable in relation to potential
benefits.
FDA officials deciding whether a product is safe
and effective enough to release into the market can also take into
account relative harms and benefits. Former Commissioner David
Kessler did just this in 1992 when he said that silicone breast
implants would be available only to women who had had mastectomies.
He decided that the benefits of the implants used for cosmetic
purposes failed to justify exposing women to risks of this device.
That is, the risks of the implants were unreasonable in relation to
the cosmetic benefits.
In his judgment, implants for
enhancement purposes were too risky, and, thus, unsafe. But the
risks were acceptable if the implants were part of treating a
disease.
Now, in defending the ruling he wrote, "Certainly,
as a society we are far from according cosmetic interventions the
same importance as a matter of public health that we accord to
cancer treatments." So whether or not one agrees with this
particular judgment, I think the case does show that existing FDA
standards permit the agency to make decisions based on comparative
harms and benefits available through biotechnology interventions.
Nevertheless, I do agree that broader standards than
currently exist are needed to respond adequately to these
innovations, and also that the current oversight institutions are
inadequate to produce such a response.
Indeed, the current
U.S. regulations explicitly direct IRBs not to consider as research
risks, "possible long-range effects of applying knowledge gained in
the research -- for example, the possible effects of the research on
public policy." Yet this is exactly the sort of effect that Fukuyama
and many other people are worried about.
Now, of course,
assessing the moral and social implications of biotechnology
innovations presents daunting questions. In most cases, review
groups have to evaluate potential harms and benefits to future
generations, and these are effects that are highly uncertain and
depend on many other variables besides technology development. I've
heard them described as radically contingent.
And so
settling on general principles won't be easy. For example, in
Frank's materials he mentioned the precautionary principle that they
use in Europe to assess new agricultural biotech innovations. Should
we have a similar principle with human biotech innovations that
requires some sort of demonstration that these innovations are "safe
for society"? And then, what does "safe for society" mean?
How do we determine when a technology presents too great a
threat to shared humanity? And these are terms that Frank mentioned
in his materials as sort of general standards.
And then,
also designing a review process is difficult. If we're going to
assign these decisions to review groups, what should the composition
be of the group? Which professions should be represented? And other
kinds of experts.
If we are to include public
representatives -- and I do think we should -- we would want to find
people who are not intimidated by the experts and who can inject an
independent voice. This has been a problem with IRBs who are
supposed to include people like this, but it can be very difficult
to find them.
We also need to recognize the cost of a good
review system. I think as we are learning from our council
experience, it's really tough to do justice to these kinds of
activities and still keep your day job. So, again, this is one of
the major problems with IRBs. Everybody has their "regular job" and
is scrambling to devote enough time to this review responsibility.
So we have to think about where the resources will come
from. An underfunded oversight system that looks great on paper
won't have its desired effect if there's not enough money to pay for
it.
And, finally, apart from this call to regulate, Frank
argues for certain substantive restrictions on cloning and other
biotechnology developments. At the same time, he recognizes that in
the contemporary United States there are strong social pressures
that favor scientific freedom, economic opportunity, reproductive
choice, and improvements in health as well as quality of life.
In our democratic system, groups representing these
interests will undoubtedly participate in designing the oversight
system and, thus, the standards and structures are likely to take
these interests into account.
My own view is that
encouraging a thoughtful approach to regulation will require much
better communication with the public about the technologies at
issue. I think a major problem today is the failure of the media,
industry, and scientific organizations to acknowledge how uncertain
are the potential benefits of this technology, and also to place
these developments in the context of a nation and a world that are
struggling to meet basic health care needs of many people.
So, in sum, Frank's account has two elements. One is on the
need for regulatory institutions, and one is on what he believes
should be the desirable content of that regulation. It might not be
difficult to reach agreement on the first element, but I think that
substantial barriers to agreement on the second exist. And this is
why I think a lot of times the institutions don't get created,
because people can't agree on what even the general principles would
be.
Despite all this, I do think the Council should take up
Frank's charge and consider next steps. That is, what general
principles should govern biotechnology research and use? And what
would be the characteristics of an adequate regulatory system?
In one sense, I think our Council is a good test case. We're
very diverse in our disciplines and our values, and, thus, if we can
begin to answer these questions, perhaps other groups, our elected
representatives, and other government officials can do so, too.
Thanks.
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.
Jim Wilson?
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 --
(Laughter.)
-- reflects the fact that we
were not focusing on something concrete. It's not the job of this
body to make rules about Ritalin or, to use an example I threw in,
hand-held calculations. We're really concerned with the possibility
of germ line strategies, and we must be very specific in our future
deliberations in enumerating those things which are: a) sufficiently
important, and b) sufficiently likely, so that we know what we may
have to regulate.
And should the Council endorse cloning for
biomedical research, we have to be clear about what regulatory
mechanisms would be employed there. Although I think the Council
will be divided on this issue, we should not pretend that the
problem does not exist. So I think my first piece of advice is to
the staff, let's be as focused as we can the next time we visit this
question, so we can talk about these things in rather concrete
detail.
Secondly, when we design or think about designing
regulatory bodies, we must consult with the bodies to be regulated.
That is to say, the membership of this Council need not be altered,
but we must enter into some degree of informal consultation with
people in biotechnology and others who are active in the field in
order to understand what is happening.
One of the lessons I
have learned after studying political science for 40 years is that
the threat to the republic rises -- is much greater when it arises
from ignorance than from influence.
Our constitutional
system and the courts that oversee it are well designed I think, by
and large, to handle the excessive use of influence. But they're not
at all skilled at handling ignorance, and we have to figure out how
best to design something that will work in the practical world.
David Kessler's quote that Rebecca Dresser gave was to me an
example of ignorance. In the view of many people for whom I have the
greatest respect, it was, in fact, an example of duplicity when he
made certain assumptions about silicon breast implants that medical
science at that time had failed to support.
I think one way
in which to make our efforts more focused and deliberate is for the
staff, if Leon agrees, to gather information about what, if any,
kinds of regulations govern or led to the creation of IVF clinics
and IRBs, so that we'll have a clearer understanding of the factual
or legal understandings that now govern those enterprises.
And my final remark -- and I make it final because to me
it's especially important -- is that we must allow markets to
operate in this business. We do not know enough. No regulatory body
ever will know enough to manage these things. If germ line
technologies are to be employed, obviously there must be some
oversight as to which are appropriate and which are inappropriate.
But with respect to those that are appropriate, people must
be allowed to make money doing this. Because if they're not allowed
to make money, the appropriate germ line strategies will never be
pursued, and people who might benefit from these strategies will
never have the opportunity to do so.
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 do it.
And, clearly, you know, that -- there is
something, you know, really wrong with that -- you know, that model
that needs to be, you know, I think very dramatically rethought. And
so I think that, you know, one further point -- I mean, since
September 11th, there is a -- unfortunately a security dimension to
biomedical research that -- in this country that I think we have not
previously been -- I mean, we've been conscious of, but there's a
fellow that I know who is a former weapons inspector in Iraq, who is
actually trying to -- he now runs the Washington office of the
International Institute of Strategic Studies, but he is trying to
organize the global biotech industry to create a self-governance
mechanism to prevent a big disaster.
He was quoting me this
one example, that there is a private biotech firm in San Francisco
that is trying to wrap a virus inside a bacteria in order to get the
-- you know, the virus past a person's immune system to obviously
deliver a therapeutic, you know, vector. But, you know, obviously,
it can be used as a bioweapon, and his particular concern was that
they were actually subcontracting major parts of this research to a
lab in the Ukraine.
And he was saying that, you know, nobody
in Washington even understands, you know, the global biotech
industry well enough to even realize that this is a potential
problem. I mean, he said he was sure that there is nobody in the
Defense Department that had any knowledge of this company and what
it was doing.
So, you know, there is also I think that --
you know, that dimension. And so I think, you know, for a whole
variety of reasons, this is a question that needs to be looked at.
One issue that I actually had wanted to mention earlier,
which is the question of democracy. You know, in general, when you
deal with highly technical areas, like the regulation of biomedical
research, what all democracies do is to delegate responsibility to
that to, you know, so-called epistemic communities, and that's
basically what this whole FDA system is and the self-regulation that
goes on within the scientific community.
And that's, you
know, absolutely necessary because, you know, there's a high entry
price to even being able to have an intelligent opinion. You know,
it depends on scientific knowledge and background, and so forth. And
so -- and that's the way a lot of the regulation has happened up
until now.
I think the conceptual challenge is whether you
can democratize in a certain way -- I mean, I think that there are a
number of reasons for thinking that that delegation is going to be
more and more problematic as time goes on, simply because the
technologies will do things that will raise ethical problems that
people in the democratic -- larger democratic society will have
problems. Not everybody, but -- and different people have different
problems with different aspects of it, and there won't be complete
consensus. But it'll be much more controversial.
And I think
that the self-interest of the epistemic communities cannot be
assumed to correspond to the interest of the society as a whole.
That is to say, researchers have their own ambitions and goals.
There is clearly a private biotech industry that's driven by, you
know, its desire for, you know, profits, and so forth.
And
so the question is: can you modify the governance structure such
that it is not a pure delegation? Obviously, it has to be, you know,
substantially delegated. But can you open it up to some greater
degree of public participation? And here I want to divorce
completely my own views of what that -- you know, what the rules
ought to be.
I mean, I'm just saying procedurally it seems
to me that we need to think about whether there is a way of, you
know, opening up that procedure and democratizing it to a greater
extent, you know, and taking it a little bit out of the hands of the
epistemic community to allow other societal voices to -- you know,
to participate.
And I think that there are some models for
that. It's sometimes -- when I've described this to people, they say
very contemptuously, "What? You're going to have an ethics
regulatory agency, and so forth?" But, in fact, you know, that is
the idea behind the non-professional members of IRBs, that you get,
you know, social voices that don't have the same set of interests
that the biomedical research community does.
You know, the
British agency also has similar rules for non -- you know,
professional membership in its oversight board. And so I think there
are -- you know, in democratic societies there are actually
institutional models where you can, you know, broaden the kinds of
societal inputs that -- you know, that go into it.
Now,
Rebecca may be perfectly right that given the deep -- and,
particularly, the closer this gets to abortion and, you know,
embryos, and so forth, the harder it's going to be to come to any
agreement whatsoever.
But I do think that, you know, and so
it may not be possible to create these institutions, but I think,
you know, generically that's what we're talking about. And then,
there is some precedent for it, and so I think we ought to, you
know, think carefully about what that might look like.
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 it.
The more general point, though, I would like to make is that
it seems -- it might seem as though Frank's emphasis on the
regulatory aspects, and Rebecca's, is a separate topic from the
moral and philosophical arguments we've been having.
But I
think it's worth drawing out the -- some important connections
between the two, and to incorporate more explicitly some of the
regulatory restrictions we might favor into the philosophical
account, the discussion, even of the cloning issue, which we haven't
really done so far.
We haven't gotten into -- for example,
here are two ways in which the discussions are connected. The
slippery slope arguments that Charles and other -- a few others have
raised loomed large in the moral discussion about cloning for
biomedical research.
And there are those who take seriously
the worries that lie at the end of the slippery slope and also take
seriously maybe even the tendencies that Charles emphasizes, but who
may think there are practical ways through regulatory and licensing
systems institutionally to prevent them. And if that's true or
plausible, then that makes a difference for the argument about
whether we ultimately endorse cloning for biomedical research or
not.
Insofar as there are moral/prudential arguments, then
some actual accounting of the prudential measures and licensing and
regulatory measures is part of the moral argument itself, not just a
further topic for a future report.
A second way in which
these two are connected, the regulatory and the moral argument, goes
to the -- remember, we had these three categories, and group two
were those people who kind of wrung their hands and had moral
qualms, but nonetheless wanted to go forward. And it includes those
people who in earlier discussions said there should be some respect
accorded the blastocysts, even though some of us don't regard that
as a full human person.
And then, the challenge comes from
Gil and others rightly, well, what does it mean to accord some
measure of respect if you're prepared to take it apart to kill it?
How do you give actual institutional expression to the respect?
And here's another area where including discussion of the
restraints that you might want to endorse and insist on, restraints
having to do with the number of days, having to do with the purposes
to which it could be put, having to do with whether the research
could proceed if there are already existing stem cell lines of that
kind out there or not, which the British case restricts,
restrictions having to do with the requirement of depositing the
stem cell lines in a pool rather than privatizing them, which I
think the British one also includes.
It might be possible to
make out an answer maybe not persuasive in the end to Gil, but at
least a substantive, a more fully developed answer about how in
practice people in category 2 would give concrete institutional,
practical expression to the restraints and to the restrictions. And
this would be a second area where spelling out the regulatory and
licensing aspects would be part of the moral argument, not a further
consideration to be dealt with in another report.
So I'm
hoping that even in the report, which we don't have so far, on
cloning for biomedical research, it's possible to try to spell out,
even if in a provisional way, some of the regulatory restrictions
that would be associated with what we've been calling position two,
those people who take seriously the moral costs associated with
sacrificing blastocysts. And, well, what does that mean in practice,
and how does that differ from a view which would be indifferent to
that moral dimension?
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 position.
I mean, right -- I mean, it's one thing to say there's a
theoretical possibility that this could be regulated, and the
British have done it, and another thing to say this country, given
its industrial structure, its decentralized medical profession, its
different view of how these freedoms should be exercised, could do
this but may very likely not.
So, I mean, I take your point
absolutely, and we come explicitly to the discussion of the public
policy as opposed to the -- I'm almost inclined to say merely moral
considerations of this. The intersection of these two things I think
should certainly be part of our deliberation and will be.
But let me speak more generally about the regulatory matter
here. What appeals to me about Frank's suggestion, though, Rebecca's
very well-stated cautions, and Jim's skepticism, and if Stephen
Carter were here he would remind us always about how things wind up
regulating against their original intent and worry about that.
Despite those worries, what inclines me to Frank's
suggestion is this, that we meet in this room and our predecessors
met in comparable rooms, and there will be other bodies like this to
help people do their handwringing as the train goes forward.
But it's not clear that these considerations which are not
merely abstract, philosophical ones, but are matters for the polity,
for better and for worse, should find their room for expression in
various kinds of decision-making, whether it be questions of funding
priorities, whether it be the setting of certain kinds of boundaries
within professional societies, whether it be governing the ethics of
research, or what have you, whether it be at the Food and Drug
Administration.
And as I see it, and we are trying to gather
information, and at least the staff is slightly ahead of the
Council, should the Council decide it wants to go forward here,
we've at least been doing some spade work to try to find out what
happened -- what's going on in the FDA that might lend itself to the
inclusion of considerations such as the ones we're developing here.
What is there going on in the Patent Office that affects the
pace of this kind of research? What about the IRBs? And so we're
trying to get background information and invite people maybe to
prepare papers for us should we want to go forward on this area. But
it does seem to me from where I sit that right now the larger
considerations that bring us together do not have an adequate venue
for consideration.
The FDA primarily had questions of
safety. The Patent Office doesn't really care about even whether
something has criminal uses, as long as it has legitimate uses, in
deciding on its patents. And the IRBs, which are wonderful on the
protection of human subjects of research, if you can't force the
question into a sort of human subjects of research framework, you
might not be able to get to the concerns that we have.
And
the public presentation on those bodies is likely -- is very often
intimidated, and so on. So I don't think we -- the existing
structures are such that the considerations we're interested in can
find adequate expression.
That's one point. So I think we --
it's worthwhile thinking this through.
Second, to pick up
something that Jim Wilson said about the importance of involving
industry in these matters, what's really new in the 25 to 30 years
since I've been thinking about this is we now have powerful groups
for going forward, not just the scientists in their laboratories
doing what they've always done, but these powerful commercial
interests which are, for the most part, unregulated.
And my
sense of this is that it is in the industry's interest -- and we
need to persuade them that it's in their interest -- but I think
it's in their interest, in fact, to join this conversation lest some
of their cowboys produce the kind of disasters, the thalidomide or
something of that sort, in which restrictions come down and response
to disasters that will be terrible for them and terrible for us.
So we have begun to have some conversations to locate those
kinds of people who could come and talk with us, and at least enter
into some kind of conversation about what kinds of things they might
willingly join in setting what kinds of boundaries.
And, in
fact, one of the theoretical questions one wants to put to them, and
we can test it out by putting it to our members here from the
scientific community, is, can one begin to think constructively
about the kinds of moral boundaries that researchers and
technologists should observe, whether or not they take federal
funds? In other words, whether they work in the private sector or
not. And can one begin to think about this without threatening the
goose that lays the golden eggs?
If the scientists are
always saying that any attempt at regulation, or any kinds of
restriction is simply threatening to our enterprise, then I think
they also are in danger of running certain kinds of risk to their
enterprise should disaster strike.
And it seems to me it's
in everybody's interest to at least explore the question of whether
we can find, if not substantive moral boundaries, at least
procedures for considering these sorts of matters as the research
goes forward, so that the larger considerations enter, so that the
profit-makers are actually at the table, and that the working
scientists contribute in a way that doesn't stifle the research but
respects that the moral -- the moral sensibilities of the community.
So if we can't do anything like that, then we -- we will
have a good time. We might produce some documents that people will
read. But giving efficacy to these concerns where it really counts,
I think we will just fail to do that. Whether we can succeed in this
venture, I don't know. This is a high-gain, high-risk exploration, I
think, because it's not clear we can -- we know what to say at the
end of this.
But because of its importance and its promise,
I would be willing I think to invest our time and resources, if we
could figure out just how to proceed in a practical sense. And it
would at least help me, and I don't want to pin anybody down on
this, but it would be interesting for me to hear -- I hope for all
of us to hear how the researchers in the group would respond to a
request for a kind of inquiry on this.
So, Janet, and then
Elizabeth, and Dan, if you will, too.
DR. ROWLEY: I have the
impression, though I don't remember precisely, that, in fact, in one
of the National Academy reports there was a suggestion that some
kind of an advisory body or regulatory body could be established.
Now, I could be mispresenting that -- remembering that from
reading of another report. But I think that just as the individuals
involved in recombinant DNA technology recognize both promise about
the safety concerns in the early '70s, and established the RAC, I
think so, too, many members of the present community involved in
cloning also recognize many of the concerns and issues.
And
particularly, because they are so much more directly related to
people and the potential for uses than was clear in the '70s, that
the biomedical community would -- I would think, I would hope, would
actually respond positively to the suggestion that they be involved
in the development of a committee that would look at guidelines for
these kinds of questions.
And I think that as well as
looking to see what the British have done -- because it isn't as
though this is brand-new, others have done this as well -- to look
at other examples that have been successful. I noted that John
Gearhart did also mention the Canadians and thought the Canadians
had done even better than the Brits. So if we could ask staff to get
information on that, I think that would be helpful.
And I
would certainly agree with Frank and with Mike and others that in
these committees that broad representation of other groups is
certainly important.
In the National Institute for Human
Genome Research, we have the ELSI Committee, which is the ethical
and legal and moral implications of -- I don't know whether the S
stands for science or what, but anyhow it deals -- social.
So that is already embedded in one of the NIH committees,
and a proportion of the Genome Institute's research funds are
earmarked for ELSI research, so that the genetics community at least
has embraced the fact that what it does in the research arena is --
should be viewed by communities other than just geneticists. And I
think that that is appropriate.
While I have the microphone,
I'd just like to go back to some of the comments that Mary Ann made,
because she brought up the question of, what are our priorities? And
it seemed to me the bottom line she said was these are politically
dictated, and I -- I wonder if, in fact, that is so.
You can
say the priorities of where are we going are not determined by
political forces, but, rather, by events that are driven by others,
including scientists, engineers, etcetera, who come up with
discoveries that then have an impact on society. And what society is
doing is responding to these new areas and trying to figure out what
kind of a response is appropriate rather than society saying, "We're
going to go and do this kind of new thing." And so I would just
question that.
CHAIRMAN
KASS: Mary Ann, please, you want to respond?
PROF. GLENDON: Just
a point of clarification. I didn't say they were politically
dictated. I said it's a political question and something that we
ought to understand as a starting point to what extent they are
governed, as you say, by events -- that is, by default, and to what
extent there is intentionality.
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.
Elizabeth, please.
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 example.
And to answer your -- you said
you wondered if there was something in the National Academy's recent
report on -- this was the report on stem cells and the future of
regenerative medicine. Included in our handout were the first three
chapters excerpted but not the last one, the findings. But I have
the original with me, so it -- let me read you the recommendations,
which directly are pertinent to this.
So the recommendation
after finding six was a national advisory group composed of
outstanding researchers, ethicists, and other stakeholders should be
established at NIH to oversee research on human embryonic stem
cells. The group should include leading experts in the most current
scientific knowledge relevant to stem cell research who can evaluate
the technical merit of any proposed research on human embryonic stem
cells.
The roles for the group could include evaluation of
potential risks to research subjects and ensuring compliance with
all legal requirements and ethical standards.
So I think
that perhaps an implication that might have been taken from Leon's
phrase of all researchers, which the scientists are not interested
in self-regulation, I think that's -- this is just manifestly
arguing this is not the case, that there is serious interest in
self-regulation.
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 Paul.
PROF. MEILAENDER:
Actually, I think it was Paul and then Gil, but I'll go ahead of him
again, as I did once before.
Two comments, the one very
brief. It seems to me if we're going to pursue something along the
lines that Frank has discussed seriously, we may need to set aside
the language of self-regulation. That's just clearly not nuanced or
sophisticated enough.
I mean, Frank talked about how you
have to -- you do have to delegate, to some degree, decisions to
people presumed to have expert knowledge. But there are questions
about how much you delegate, and so forth, and the language of
self-regulation will not capture that I think, and we need different
language.
The other thing I was going to say is just it
relates to some things that worked their way through Rebecca's
presentation responding to Frank. And, I mean, what he has done is
really nice, but I just never know how to -- what I myself think
with respect to a certain kind of problem.
It just seems to
me the conversation will proceed much more easily with some kinds of
questions we might think about regulating than with others. And what
I mean is we have fallen into a pattern in this country that isn't
very satisfactory, but you understand why, with respect to certain
kinds of questions, say ones that involve embryos, for instance,
where we don't fund -- we don't use government funds in a way that
would implicate all of us in some way.
But we also don't
say, well, no, you know, we're prohibiting it, and we allow private
research to proceed. That leads to sort of a chaotic, not very
satisfactory situation. On the other hand, it's rather
understandable why we've gotten there.
And if we were going
to fund and regulate, once law does that it confers a certain kind
of legitimacy, and that creates its own set of problems, then. And I
don't -- I mean, I just -- I have never quite -- I don't like any of
the alternatives. I have never quite figured out how to get past
that problem.
It will be much more acute with some kinds of
questions than others in terms of the range of issues that Frank has
drawn up. But that problem of complicity that -- the legitimacy that
law confers is always going to be hard here.
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 of
research.
But there were other people at that meeting who
somehow understood the other implications. So it seems to me that
these models that we have before us are interesting, they're
appropriate for their place, but one has, I think, to renew the
consideration in the light of our present circumstances --
self-regulation, where possible, but with the input of -- with the
kind of input that's commensurate with the subject and with the
stakeholders involved.
This is not, by the way, to suggest
that the recommendation in the stem cell report would be inadequate.
That wasn't meant to suggest otherwise.
Frank, and then
maybe a couple of comments, and then we will move to -- if there are
others who want to -- Charles, did you want in on this as well? Is
that a light? No. Frank, and then --
PROF. FUKUYAMA: Well, just on the
question of self-regulation, I wouldn't banish it from our lexicon,
because it is, you know, a possible institutional model. And I think
in, you know, the field of public policy there has been a lot of
kind of theoretical work done on where self-regulation works and
where you need more formal types of regulation.
And there's
actually a lot of game theory behind this, because, you know,
generally speaking, self-regulation works when communities are
relatively small and homogeneous and, you know, where the kinds of
issues that they're regulating, you know, don't pass a certain kind
of threshold with regard to, you know, the politicization, and so
forth.
So that, for example, in the standards world, there
is just an amazing amount of self-regulation all over the world in
terms of, you know, coming up with technical standards for all sorts
of things. And this never reaches a political level, and it's all
done, you know, pretty much by insiders.
But there are other
situations where you have heterogeneous interests, where you have
cultural differences, where you have national differences, where the
issues are more inherently politicized, where these kinds of
self-regulating informal mechanisms tend to work less well.
Just an example is the internet. The internet, when it was
run by a bunch of engineers, could be completely self-regulating
because they all agreed with each other. They all knew each other
personally, and, you know, they could make decisions among
themselves. But as the internet has gotten commercialized and more
heterogeneous, that kind of solution tends to work less well.
So I just think -- I mean, this is one of the -- you know,
but there's a lot of -- there's a big body of thought, you know,
that has gone into this more general question of when you can
self-regulate and when that's not appropriate.
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?
Charles?
DR. KRAUTHAMMER: We could also
sort of think of it as we may not want to look at this as an issue
to be spoken of in general, but to apply it to the specific
questions as we come along. For example, when we get to deciding on
policy for cloning, it would be appropriate to hear, for example,
what Michael and others were talking about in terms of regulating
from those who want to go ahead and continue to make it legal.
So I think it would -- rather than speaking of it as a
global issue, I'm grateful to Frank for introducing it, because we
had really overlooked it. But to take it in pieces as we go along
issue by issue, and then we'll -- by the end of that, we may have
some idea of what a larger regulatory structure would look like
having examined a few examples of what it might do.
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 human embryo.
And
with this in mind, I would like to ask the Council to reflect for a
moment on one simple fact: that human embryos are either boys or
girls. This is an indisputable fact that's very seldom mentioned.
The human embryo, from the very first moment of life as a
single-celled embryo, is either a boy or a girl. That is, either a
male or female.
Every high school student, in fact, learns
this in biology class. One's sex is determined by chromosomes which
are present at the very beginning of one's life as a single-celled
creature. So I would ask you to keep in mind that when you are
talking about human embryos you are talking about male and female
human embryos. Knowing that every human embryo is either a boy or a
girl adds an important perspective to the moral status and value of
the human embryo.
One's sex is probably the most fundamental
component of one's personal identity. And we know this when we
reflect upon ourselves. We also know this when we reflect upon our
everyday encounters. The sex of a person is the first thing we
notice when we meet people on the street, and it's a major
determinant of how we interact with people.
We will never be
able to empirically confirm the presence of the soul, but we know
that in order for a person to exist a living, human body must exist.
And we know that human bodies essentially come in only two forms --
male and female.
At the single-cell stage, we can identify a
living male or female human body. At the most -- one of the most
fundamental components of personal identity is present at this very
beginning stage of life. I believe that this alone is enough reason
to recognize the personal rights of the human embryo.
So I
think here we must be honest. Many are apprehensive about
recognizing the rights of male and female human embryos.
As
we all know, many widely accepted practices subject human embryos to
death. Here I'm referring to the practices of IVF, embryonic stem
cell research, even contraceptive practices which prevent the
implantation of the embryo.
Clearly, if we were to boldly
recognize the personal rights and the dignity of the human embryo,
we must then reject all these practices that I have just mentioned.
The President's Council on Bioethics has a critical teaching
opportunity here. History is filled with examples of societies that
accepted a mistaken understanding of human dignity, and they allowed
horrible crimes to take place against innocent people, yet people
came together to correct those mistakes and to defend the dignity of
the person.
You have a chance to lead Americans to a renewed
understanding of human dignity, and I ask that you overcome all the
apprehension. Human embryos are either boys or girls.
Thank
you.
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 them.
And he also says that John Robertson
accepts my point on that in order to point to the opposite moral
conclusion about both.
First, it was really Dr. Robertson's
point to which I was responding. My paper was written as a response
to Robertson's. But, more importantly, I don't think I've ever
argued there's no moral difference between the two practices.
Obviously, I think the practice of specially creating
embryos simply to destroy them for research is more morally
abhorrent in more ways, just as it would be more horrific to
conceive a child solely in order to abort her for organs than to
abort in some other circumstances. My point is just that that does
not mean the other abortions are morally right.
The point I
was trying to make is this: there is often some measure of
selfishness in our reasons for conceiving children, just as in our
reasons for doing many other things. As a Catholic, I tend to
attribute that to original sin.
For example, in having a
child, I may have in the back of my mind that I would like this
child to go to college and achieve things that I never did, to give
myself some vicarious satisfaction. And in that sense, I am treating
that child partly as a means.
But this becomes much more
problematic if we are treating our offspring as mere means in ways
that do them great harm for the benefit of others. And if we explore
our reasons why so many of us, quite rightly, strongly object to
creating embryos in order to do them harm for research, we will find
in our feelings the roots of an argument that it is wrong to harm
embryos generally. But I didn't equate the two practices.
Secondly, I wanted to comment briefly on the slippery slope.
I wanted to confirm what Dr. Krauthammer said yesterday. During the
debate on use of spare embryos in Congress, every member of
Congress, every Senator, claimed to oppose specially creating
embryos for research, by cloning or other means.
Outside
research groups and patient advocacy groups declared the same
ethical position, arguing, for example, that the Clinton guidelines
on stem cell research kept this research within ethical limits
precisely by excluding any involvement in special creation of
embryos for research.
But when the debate switched to
cloning for research, many of these Senators and outside groups
immediately switched their position and endorsed what they had
previously condemned.
I am tempted to agree with what Dr.
Rowley said yesterday that this was not a slippery slope, that these
people always knew where they wanted to go in the end. But that
seems to suggest that they were simply being deceptive in their
first position and raises the question why we should believe some of
their claims now.
The rule "fool me once, shame on you; fool
me twice, shame on me" seems to hold here. I do think there was a
great deal of insincerity in the earlier claims to share moral
concerns of the rest of us about specially creating.
My
point is simply that I have no reason to believe that the slope does
not extend further down. I want to raise two things about -- does
this stop with the embryo?
The latest bill, alternative bill
to be introduced -- and it has been called a compromise by its
sponsors, S.2076 -- does not, like some previous bills, ban the
implantation of cloned embryos in the womb. It allows the
implantation of cloned embryos in the womb, as long as that is not
done for the purpose of "creating a cloned human being" by which I
assume we mean a born human being or the bill would be incoherent.
In other words, this latest bill already endorsed by some
Senators would allow implanting cloned embryos in the womb, to grow
them to a certain stage of gestation at any time before birth, and
then kill them for their organs.
The other reality is that
when asked to proffer examples in animal models of what therapeutic
claims can be made for therapeutic cloning, supporters have noted
two studies. The first involves trying to make new kidney tissue for
cows, but it required growing the cow embryos, the cloned cow
embryos to fetal stage and then harvest their kidneys.
The
second was an attempt to cure an immune deficiency in mice, and that
did not work until they actually brought the embryo to live birth
and then harvested its adult stem cells for treatment in the
original mouse. In fact, there are no models at this point of
therapeutic cloning that stays at the embryonic stage.
And I
would like to offer for any Council members who are interested a
document that offers a little snapshot of the advances that are
being made now against some of these diseases without using any
embryonic stem cells or cloning.
Thank you.
CHAIRMAN KASS: Thank you very
much. If you'd give the documents to the staff table, we'll see that
everybody receives these.
The last comment is from Susan
Poland speaking as a private citizen. Ms. Poland, welcome.
MS. POLAND: Thank
you. Mr. Chairman, members of the Council, my name is Susan Poland,
and I work as a library researcher for the Bioethics Library at
Georgetown University.
However, I am speaking only on myself
and on behalf of no other entity. I'm also speaking from my
experience as one of the first 10 women police officers in New
Hampshire, and also as one of the first four lab techs in basic
reproductive research at the Jones Institute in Norfolk, Virginia.
Recently, I co-authored a bibliography on cloning. Others I
had done were on gene patenting and bioethics commissions. So I'm
also speaking from what I learned from those.
And I have two
basic insights, one comment on terminology, and then I'd like to
really spend most of the comment time on illustrating what it was
like to be, in 1985, a first-hand account of doing unregulated in
vitro fertilization basic research.
First, a clone is a
group of genetically identical offspring or progeny. It implies
birth, and, therefore, I think that reproductive cloning is
redundant, and therapeutic cloning is a misnomer and misleading,
like gene therapy is. I would like to see you use the term "IVD" for
in vitro division or duplication.
If you're going to have
implantation into the uterus in hopes of a pregnancy, IVD/ET, just
like IVF means in vitro fertilization, not necessarily followed by
implantation, or IVF/ET.
My first comment or insight in
working on the cloning bibliography is that the U.S. patent system
is the most powerful and most unique law enforcement regulation that
this particular government has for controlling research done abroad
and in the U.S. You cannot really regulate the scientific research,
but you can regulate and control access to the patent system.
And I was expecting or hoping that like you have IRBs or a
super IRB for FDA, you would have something like RAC, because the
patent system right now is overextended. It does over 10,000 patents
applications in one year. It took over 40 years to reach the first
10,000 applications. Those people are not qualified, I believe, for
adequately evaluating whether or not research is done correctly
under bioethical principles.
Second insight -- that was a
short-term insight. A long-term insight is that the legacy, I
believe, of this group will be its impact on human, and the
definition of human to further councils and lawyers in the future,
maybe not in my daughter's generation but the generation following
that.
If you take a look at what's happening with
cooperative robotics, autonomous robots that are making decisions, I
wonder if we're going to define "human" as one cell, whether it's an
embryo or what, and go back to the racist policies or miscegenation
and one drop of blood.
And now I'd like to go into
explaining what it was like to be a person that walks into a
bioethic -- excuse me, into a basic reproductive research laboratory
with a background in law enforcement when you had a .38 Smith &
Wesson on your hip, but you also had some experience with bioethics
and the issues.
The first time I was there they looked at me
like, well, are you going to stop the conversation talking about
law, or are you going to just tell us what to do as a bioethicist?
And I told them, "No, bioethics is not a badge."
Lawyers
have -- lawyers and policemen have judges. They give you a final
decision. Bioethicists and theologians have no judge. And so the
discussion continued, and they would talk, and it was a very small
group. It was very similar to what I believe 19th century Britain
was for discussing science.
We had close communications. I
worked with Gary Hodgen, who you may know left NIH in 1984 because
he could no longer do embryo research as a bureau chief. And the
Joneses -- Howard and George-Anna Jones had left Johns Hopkins
sometime before because they were no longer allowed to teach because
they had reached the age of 70.
So we were working with our
small group. And, like I said, I was one of the first four. There
were close ties to Patrick Steptoe and John Edwards in England.
Everyone knew everything. This was in the age when there were no
faxes. Well, they were relatively new. No cell phones, no internet.
You were lucky to get things.
And at the time, in the U.S.,
what had happened with us doing basic research was a scarcity of
materials. We were working basically with animals, and, when we
could get them, human materials. But because of the fall of the
Marcos regime, we were not allowed to get very many primates. They
are very hard to get. And when you could find a monkey to work on,
if you were using human material, just like with vaccines, three
times of exposure to human hormonal material would immunize the
monkey and you would no longer get valid results.
So,
consequently, a good deal of research in IVF was done using the
litter-bearing models of mice, which their ovaries do not react the
same as, say, a singleton birth.
At the same time when we
were sitting there, I remember one of the business meeting
discussions like, well, what do you think? Do you think we should
screen for AIDS? That seems to be a new disease. And you know what
has happened since then.
I also sat in a meeting with
Etienne Balieu, who was running Roussel-Uclef. We were doing work on
RU-486 with one other woman. It was a small group of men and us two
women. We were the only two people that thought we still agree with
diaphragms, because we like control of our own bodies. Forget about
giving us drugs that we can't shut out or whatever.
At the
same time we were working with RU-486 on monkeys who were giving
still birth, or the newborns would die relatively soon,
Roussel-Uclef had signed an agreement with the Chinese government to
test on people. When you have a policy of one birth or less, it's
very easy to allow your people to go sterile.
Also, at the
same time, in the summer of 1985, a professor named Akira Iritani,
who is still in practice and still working today, came over. And it
was sort of like the beginning of 2001 when you see the bone going
up in the air from the cave man, and you see the space ship.
We had just gotten our first micromanipulator, a Japanese
machine that Professor Iritani had used quite a bit. He had a
graduate student, much like Briggs & King -- King being the
expertise for Briggs with all the insight. He had a graduate student
when he showed us at the end of his term staying with us that could
do two to three hundred embryos in an afternoon, splicing them,
which we would call now embryo-splitting or blastomere separation.
And one of the slides at the very end was a picture of five
identical goats born by an eight-cell embryo. And I thought my God,
there you have the perfect drug testing system for a pharmaceutical
company. I have as yet, as a professional researcher, to see
anything in print. If you have any sway with people at the NIH, both
at NLM and with research to get more Japanese work put out into the
U.S. mainstream for people to know, that would be very nice.
China obviously takes one view based on a Confucian and
socialist system, or a Communist system, rather, of human life.
Japan takes a different view. Professor Iritani shocked even me when
I discovered that in January this year he announced that his group
and a different university is viewing genetic engineering -- had
actually inserted a spinach gene into a pig, and then produced two
successive birth generations. From my Western mind, I don't mix
plant and animal kingdoms.
And then, lastly, back in 1985,
we were there watching what was happening in 1984 with the Medical
Infertility Procedures Act when it was passed in Australia in
Victoria. And the "hot dogs and cowboys" were going to be put in
their place by the legislators.
Well, they certainly did.
They emigrated to the U.S. as IVF Australia, became IVF America, and
today they are now IntegreMed, Incorporated, responsible for
one-sixth of all IVF births in the U.S., and our local outlet is
Shady Grove Adventist Hospital.
So I feel that when
Australia came into the U.S., what basically we lost was that very
close-knit tie of research and clinical care, because it suddenly
overwhelmed the system and it became just clinical care and
consumers.
When I was working there in Norfolk doing basic
research, we got human materials. There was a pecking order. Any
human material was first used for patient care, and those people
there would decide which ones were the best ones with the best
opportunity of going on to help these people that wanted to have
babies.
Anyone else would come second for research, mind you
that not the best-looking embryos always were the best ones that
went and implanting. So we had to rely on their judgment.
We
did use cadaver eggs. I'm grateful for the one woman that did donate
her ovarian tissue. But the eggs, of course, were dead, as I believe
many of the 100,000 embryos are that are sitting around in the
nitrogen tanks throughout the country.
But both groups, the
clinical practice and basic research, were in service together on
improving care. I've never seen such a group of remarkable people
with high esprit de corps.
And there wasn't a feeling that
this is a researcher-subject relationship or a doctor-patient
relationship. We were more or less fiduciaries, trying to do best
for individual people and yet also trying to do best for society by
improving the science.
My own feelings about the moral
evaluation of this, having been given the power to use my own
judgment when I was 23 to use deadly force to kill a person if I had
to, was that this wasn't destruction of embryos. This was actually
loss. There was a real grief every time we had to kill an animal or
lost an embryo that we just didn't work.
I'm sorry. Am I
over my limit? Is that just some --
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 HEFA.
They also use, by the way, the British term,
which is cellular nuclear -- cell nuclear -- CNR. I'm sorry. Cell
nuclear replacement I believe is what it is.
I was going to
ask you, and then respectfully request, and actually I think the
term I want is beg -- beg you to regulate this. It was very scary to
do IVF, which is fertilized or sexual reproduction, and now you're
looking at in vitro asexual reproduction. To do it in an unregulated
atmosphere because you didn't know what you were going to do, if you
were going to hurt someone, and where the government would draw the
line suddenly.
And that's about all I can do is ask --
there's a balancing mechanism. My own -- as I started to say, my own
moral feelings about this, having been given deadly force, I have
discovered have changed. And they evolve the more and more
information I take in.
Thank you.
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 cloning.
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 a question?
CHAIRMAN KASS: Is Richard still
here? Yes, please, Richard.
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 adjourned.
(Whereupon, at 12:18 p.m., the proceedings in the foregoing
matter were adjourned.)
back
to
top
|