Friday, July 12, 2002
Session 6: Agenda of the Council
CHAIRMAN KASS: Could we return please and
Frank, is the metaphysical group going to return?
session is devoted to taking stock of where we are and beginning to talk about
some future directions.
Just some general considerations, a reminder of
some things that are at least under consideration, and then I think a free
ranging discussion that would help us think and make plans for the
The first consideration, this Council by executive order is in
existence till the end of November 2003. That's 16 months, something like that,
and it's unlikely that we can do more than a couple of things and do them well.
So there are lots of things that would be worth doing, but we'd have to
make some choices of more important and less important. And there are some
things worth doing, but might not be worth doing by us, given our strengths and
talents and the like.
Second, there is a consideration that for some
people the issues that we should take up are things that bear upon immediate
policy questions. There are other people who think that what's most important
for a body like this to do is to lay the groundwork for various kinds of
questions that might be coming and bring to public view certain important
considerations that are insufficiently attended to.
example, would be one such topic.
And I think we've learned from our
experience over the last six months that it matters if you're trying to conduct
a fundamental inquiry whether or not there is something else going on around you
that has a kind of urgency in which there are various pressures brought to bear
upon what we do.
This is a Bioethics Council, and as indicated at the
start, ethics doesn't simply stop at the doorway to politics and policy. That
has a deeply ethical dimension.
But we also have to be very careful as to
whether or not we get caught up in things that are around us and simply respond
to those kinds of pressures.
At the moment we have not been asked by the
President to tackle any particular topic, though that could come. And I do know
that that part of the executive order which asks the Council to explore the
human and moral significance of things is taken seriously there. They're not
necessarily simply interested in advice on this or that practical question, but
with a view to this field as a whole and the fact that its issues will be with
us for a long time, we do have the green light, I think, to find our way on the
basis of what we think is either most urgent or of the greatest
That, by way of some general considerations. I may have left out
We have, as we were doing the cloning work, we have embarked
on at least three other possible lines of inquiry. One was stem cell research,
and we had yesterday our second — our fourth session on stem cells. We had the
two presentations from the scientists, Dr. Gearhart and Dr. Verfaillie. We had
Dr. Outka's presentation and discussion on the ethics of stem cell research, and
yesterday Dr. Baldwin on the implementation of the policy.
We've had two
sessions on enhancement, one prompted by the working paper of the staff, and
then the one we had yesterday afternoon, and we've had under the broad heading
of regulation, I think, four sessions, one, the general discussion prompted by
the readings of the material that Frank provided from his own
At the last meeting, two sessions with Lori Knowles and Dr.
Baird on the international models, and then since we're treating the question of
the patenting. Actually maybe I'm wrong. Maybe that's five
Well, we've had two sessions, several sessions on patenting,
which does also deal with the general question of if not regulation, at least
the interface between research or science and society applied not to this
particular technology or the next, but to things in general.
there was a discussion that suggested one might enlarge the patenting question
either in two directions, one in the direction of science and commerce, the
other in the direction of property and the body.
So there was the
possibility of thinking about patenting by itself, patenting in relation or as
an instance of and in relation to certain other things, and further questions
developed along the lines of if one wanted to pursue the question of
enhancement, to what extent is the sports example a useful instance?
one want to think about enhancement? And I don't know whether, Dan, your
suggestion that we take up germ line modification was with a few to the question
of enhancement or simply the question of remedying single gene mutations, but
Dan had brought that up as well.
That is simply by way of reminder. I
have a couple of thoughts myself, which I'll at least put out there. I would say
that a bifurcation of our efforts, to think about maybe two large projects if we
could figure out how to do them well might make sense. I'll simply speak for
myself, but I'm really open to suggestion.
One, it's very nice to be
liberated, I think, simply from the question of the ethics of the means and to
try to think about some of the difficulties that come from where these powers
are to be used.
And I don't like the distinction between therapy and
enhancement as the best way into this subject, but that's onto something. If you
go past the remedy for the treatment of individuals with known diseases, one has
wandered out into unchartered territory. No previous council has ever really
taken this matter up.
It is not an immediate policy question, to say that
somebody is waiting to hear from us on this, but I think that in some way this
might be the largest question where much of the greatest disquiet about what
might be possible, and we could talk it through and maybe even address some of
the disquiet and tone it down and also provide some ways of thinking about
So the use of these powers beyond therapy, I think, is one large area
which would be unchartered and might be useful.
And the other large area
has to do not with this or that particular moral question, but with the
institutional questions. Ted Friedmann finished his talk yesterday with a kind
of plea that we give some attention to what might replace these various ad hoc
commissions that meet and talk. This has been Frank's talk from the day of the
And that seems to be a way that at least in the majority
recommendation talked about the importance of beginning to think through ways of
surveying this entire field with a view to what might be done not just by way of
commentary of advisory bodies, but for some institutions that could see to it
that the large questions we carry about are even considered, monitored and
perhaps even regulated for.
But that's at least where I would be inclined
to start, but before we sort of broke for the summer, I thought it seemed to me
we should hear from everyone and see whether we can formulate some useful plans
between now and September when we come together.
So with that rather long-winded introduction, please. Mary Ann.
PROF. GLENDON: Well, on the enhancement/therapy topic, I
would hope that if we choose to pursue that that we'll let it open out into the
questions that are inevitably involved of allocation of resources, that is,
allocation both of the human resource represented by scientific energy and
creativity, but also allocation of scarce economic and medical resources.
CHAIRMAN KASS: Frank, please.
DR. FUKUYAMA: Well, I'm going to sound like a broken record
on this, but, as your summary suggested, you know, my position has been fairly
clear that I just think that councils like this are not going to have very much
impact unless they try to concretely discuss ways of institutionally embodying,
you know, ethical concerns into routine policy making.
And as the
presentations on the HFEA in Britain, you know, last session, and the Canadian
regulatory structure that they're putting in place indicated all of those bodies
had their origins in a group like ours that issued very concrete, you know, a
permanent oversight board that took into consideration ethical
And I think that all of these issues that we're talking about
at a fairly abstract level having to do with enhancement, you know, versus
therapy and so forth can be given a much more concrete focus if it is put in,
you know, the context of, you know, actually institutions and how they would
grapple with these sorts of problems, and I think that's one point.
second point is if you look at the two in the majority and minority positions
that we adopted or that are contained in our report yesterday, both of them make
regulation central to, you know, their outcomes.
The first position says
the moratorium, among other things, will be used to think through a regulatory
Position two says we are not going to proceed with research
cloning unless there's an adequate set of regulatory safeguards in place. So
both of them, you know, push us to move down this road, and I would be loath to
slough this off. In fact, in some of our discussions about the final report, I
mean, there has been some suggestion that maybe there should be a separate, you
know, commission or something to look at these issues.
And I feel quite
strongly that that should be our duty, that we should really use the year and a
half left in the life of the Council to look at this seriously.
does not preclude by any means, you know, ignoring any of the, you k now,
ethical issues or have this rich kind of conversation that we had this morning,
you k now, about specific issues, but I do think that it would help to focus the
discussion very much if we looked at it in these very practical
And, finally, I want to also endorse, you know, Dan's suggestion
from yesterday that there is a very clear line that moves from cloning to
preimplantation genetic diagnosis and screening ultimately to germ line, and
all of those, I think, could be dealt with institutionally by the same
I mean, if you set up a regulatory system to put some rules
around embryonic cloning, that same institution will function to approve
procedures in pre-implantation diagnosis, and it can also make rules for germ
line, and so I think you will not only deal with the short term problem of how
you proceed on cloning, but you will also set the foundations for issues that
you can see either here, now, as in the case of pre-implantation diagnosis or
over the horizon, you know, with the germ line, and you'll kill all three of
those birds, you know, with a single stone.
CHAIRMAN KASS: Paul.
DR. McHUGH: I want to second what Frank is saying and put it
in another way. The appreciation of one group of ethics councils after another
often turns on a discussion of various means that are employed presently in
And remember our Council is a Council on Bioethics, and
therefore, ultimately should be talking about the ethics of ends, as well as the
ethics of means, and I can tell you knowing ethics councils in various hospitals
around the country, the issue of ends is very seldom their matter. They function
very often accommodatively towards the culture within which it lives, and I
believe that a regulatory body or a larger element of our country's government
that is speaking now about these matters would deal with issues of means,
broadly speaking in relationship to the things which Frank has mentioned, but
would gradually develop a coherent discourse on ends that I think is
CHAIRMAN KASS: Let me ask on the — sorry. Gil? No, please,
PROF. MEILAENDER: Just a couple of comments. One of the
things I've thought about, and I'm uncertain about this, and it's undeveloped,
but it seems to me at least I've begun to think there are some topics that you
can deal with better in some settings than others. There are some topics that
you can deal with well if you're teaching a class and you have a semester to
kind of unfold the whole process of reasoning so that when you get here, you
know, you refer back to all sorts of things that you've done and so
We don't work in that way and meet in that way, and the
enhancement topic worries me for that reason. I may just reflect my own
difficulties with it. I just think it's a conceptual bog. I mean, I think it's
very difficult really when you go to work on it.
You know, it's easy to
talk about the distinction between therapy and enhancement. It's very hard to
make it out in conceptually clear ways, and I just register the worry — it's
no more than that — but the worry that we might trap ourselves in something
that we can't dig our way out of in the kinds of meetings that we have.
would rather see us take a piece of that topic if we wanted, and I mean,
actually Charles had a number of meetings ago suggested germ line. When we had
one of those sessions on enhancement, he had suggested that, and Dan has come to
In other words, if you focused on one little piece of it, of
course, some of the larger conceptual questions would arise. You'd have to deal
with them, but not as if you were writing the book that finally clarified the
concept of enhancement, but you know, in the context of a particular
I just have this strong feeling that we might have more success if
we approached a topic like that in that way. So that, on the enhancement
With respect to the regulation topic, not as close to my heart as
to Frank's, but it's fine. I have no objection to it.
There, again, I
think a discussion might be most fruitful if it weren't a discussion in the
abstract or were a discussion of a proposal perhaps formed by even a
subcommittee of this body or something like that rather than just sort of
flailing around thinking about regulations so that we could see what a proposal
might look like and begin to think more fruitfully about it.
think there are some serious questions about exactly what kind of a regulatory
body one would want, whether or how responsive to citizens we wanted it to be, for
instance, and so forth that I'd want to pursue at any rate.
finally, I want to say I have thought for some time — I mean, it's not on your
list and I guess it's not on anybody's list right now — but I actually think
that the whole issue of organ donation, transplantation, sale of organs, which
there's been a lot of stuff coming back about just recently again is a very
There's a lot to be learned about what actually goes on
in the industry. It opens up into some of those wider questions that people were
interested in yesterday, but it still remains. You can keep it focused on a
question like sale of organs, for instance, which implies all of those issues
about the commodification.
I just think that it's that kind of topic anyway
that it seems to me that we're looking for that can be focused and narrowed
while it still has the broader implications, but I don't think we're going to
write the book about the broader implications on any of these.
CHAIRMAN KASS: Well, let me ask just to get clarified on
this topic of germ line modification. What does it actually mean to the people
we're talking about? What are we talking about here? What's the recommendation
for this as something that we should take up?
Could someone specify what
this slogan means? What is it?
Maybe I should ask Dan what he had in mind
when he suggested it was the natural
DR. FOSTER: Well, I think that if you look at gene therapy,
there's very little controversy in terms of, let's say, therapeutic somatic cell
therapy. In other words, as Ted was talking about yesterday, you know, you have
a disease, adenosine deaminase deficiency, and you've got a severe combined
immunodeficiency disease where the person has to live in a bubble or something
like that; that you can treat the one patient.
We've been doing it by
injecting the enzyme, but now it looks like there's been a repair which is
genetic. So that only affects that one person. It changes that one person's life
and has no implications for further generations, either good or bad.
on the other hand, if you have a defect which is not a polygenic defect, like
sickle cell anemia, for example, and you decide, well, we'll just wipe this out
by correcting this in the gonads of carriers of the gene, then that has, unless
this dies out in some sense, that has implications in perpetuity, and you know,
there's a sense that somehow in evolution the sickle cell gene occurred to
protect against malaria because malaria, you know, was the widest cause of acute
And even though this gave you painful crises and constant anemia,
that was better than dying acutely. Nature said this is better than dying
acutely. So in one sense, because in African Americans this is a terrible,
terrible disease, you'd say, "Let's wipe it out."
But then, on the other
hand, you might have to think about, well, are we going to then have resistant
malaria, and so we're going to wipe out Africa not just through AIDS, but
through malaria, in other words.
So there are implications of passing
this down that I think we have to look at, and I think that I have concerns
about some of this. So that's what the thing is.
I mean, gene therapy has
some acute dangers. If you give too much of the virus, like the Philadelphia
experiment and so forth, you can kill somebody, and it might be in an individual
because genes talk to each other that putting in and repairing one gene defect,
cystic fibrosis or whatever, that it might have effects to bring out or to, you
know, other genes.
But it's at least in one person, and the risk is
limited to that.
Now, you could also look at the germ line enhancement
theories. I mean, I think Janet's point is that intelligence and things of that
sort are so complicated that it's not likely to be realistic in the short run,
but that's the general thing, that a single gene therapy is good or possibly bad
for a single person, but does not implicate the race or something like that.
CHAIRMAN KASS: Is this — again, just for the record, these
are speculative possibilities that people have talked about, but if someone
where to say, "Well, look. We have pre-implantation genetic diagnosis." That's
something else, right? That affects the individual that's there and gets us into
some of the usual kinds of questions.
But how realistic and how likely is
it that we're going to see, let's say, in the next decade or even two any
serious attempts at human germ line modification?
Anybody interested in
doing this? And who would give them permission? I mean, Janet, do you have some
— what would you say?
DR. ROWLEY: Well, I've expressed my views several times,
both in the media and outside of it, that I think this is extremely unlikely
that we will have effective germ line gene therapy that we would then have to
worry about in terms of its impact on both society, on individual children who
might undergo such treatment, and that there are certainly other issues that are
I would have thought more pressing than this, and even to take up Dan's
So, you know, you think about gonadal treatment of someone who's a
carrier of sickle cell disease, and then you try to think, well, how would you
do that, and you know, you replace all of the oocytes in the female or all of
the spermatogonia in a male, and if you don't replace them all, then there is a
certain probability that the defective sperm or defective egg would actually be
the one that would give rise to an offspring.
So I mean, I think this is
so unlikely that we would be wise to wait on a topic like this until it became
more of a reality.
CHAIRMAN KASS: Bill and then Frank.
DR. KRAUTHAMMER: Could I make a response to that? Is that on
the same subject?
CHAIRMAN KASS: Sure.
DR. KRAUTHAMMER: Germ line therapy would be a subset of
enhancement. It's serious, permanent enhancement, and if it's assigned to
fiction right now, and I defer to Janet on this, I still think we could
contribute to the question for the future by looking at enhancement that can be
done now, which is non-germ line, which could be pharmacological as we discussed
In other words, as you said, Leon, no one has really seriously
looked at enhancement, and we could contribute to the future debate about germ
line by focusing on the current debate about doable enhancement through drugs
and other means or somatic genetic therapies.
So I think that would be a
way to go about it. We wouldn't have to focus on germ line, but the implications
would be obvious and clear for whenever it became doable and necessary.
CHAIRMAN KASS: I'm not sure, by the way, Charles, that I
would say that if I understood what Dan was saying that you would want to
describe germ line gene therapy as enhancement. You would rather treat it as
very sophisticated preventive medicine, right?
DR. KRAUTHAMMER: Well, but I don't think that would trouble
— well, perhaps it would, right.
CHAIRMAN KASS: Well, it troubles Dan because it's —
DR. KRAUTHAMMER: But not for ethical reasons. For safety
CHAIRMAN KASS: But those are, as I reminded weeks ago —
DR. KRAUTHAMMER: No, I understand.
CHAIRMAN KASS: — it's an ethical question whether you would
DR. KRAUTHAMMER: It is, but —
CHAIRMAN KASS: — inflict this on generations to come when
you don't know what you're doing.
DR. KRAUTHAMMER: But it is less interesting because the
answers are much more obvious. If you can do a lot of harm for eternity, you
probably don't want to do something. So in terms of therapy, I think it's one
thing. In terms of doing it for enhancement, I think it makes it all the more
difficult an issue.
But I don't see why we have to focus on that if it is
going to be so speculative. We should focus on what is doable today.
CHAIRMAN KASS: Bill and then Michael and then Rebecca.
DR. HURLBUT: Well, just one little thought on this. There is
a practical dimension to our asking this fundamental question of how doable is
germ line enhancement or even therapy at this point. There's quite a lot of
discussion in the popular press and serious books, such as one with a title that
includes "post-humans," have been written on this subject, and I think it would
be a service to our society if we were to take the insight that Janet has
mentioned that a lot of our images of how genetics work are simplistic based on
simple Mendelian models, based on simplistic notions of disease, genetic
disease, not acknowledging there are actually syndromes, that there's
pleiotropy, which means — for those of you not scientifically trained,
pleiotropy means one gene does many things in the body. It's not a one-to-one
correspondence between genes and traits, and polygenic inheritance, which means
that most traits result from many genes operating together.
If we could
acknowledge those two facts, bring them out into the context of the discussion
and make a limited report to the public on the realistic possibilities and
concerns on this issue, we would at least do a service to the general level
journalistic discussion and maybe help keep science from a bit of bad
I think there's a practical dimension that I think the scientific
community doesn't take seriously enough in America, and that is the degree to
which the popular mind can turn against science. And look what's happened in
England with genetically modified organisms. It's a significant social
I suggest that we might want to think about for this issue and
maybe several others, that we should request of the National Academies of
Science some kind of reports on a few of the scientific groundings of the
ethical issues we want to discuss.
Perhaps we should ask them to give us
a report on what the realistic possibilities are for germ line modification and
then on to the question of whether human beings could realistically enhance
CHAIRMAN KASS: By the way, one other general consideration I
should have mentioned at the start and it's pertinent here is that one of the
other things that should govern our choices is whether there are other people
and groups even better situated and actively involved in this.
And I do
know that some of these questions are part of the thinking for the next phase of
the genome project, and particularly the ethics component of this.
that's not to say that we shouldn't do this, but we should find out certainly
how they plan to proceed along these lines, and I wouldn't be surprised — are
you not active there, as well, Rebecca?
Yeah, maybe when you get the —
do you want to speak first?
PROF. DRESSER: Sure. Actually, there have been some really
good reports done recently on this. Well, I think they're good. AAAS has done a
report on germ line interventions, and there's a book that I think is coming out
this fall by people in that project. That's a very good resource.
did an excellent report on prenatal genetic modification where they explore some
of these questions, and it's really great science. I think that was
So those would both be good things to look at.
another thing that affects my thinking on this is that I think we made an
implied promise in our report to address some aspects of reprogenetics, and I
feel some obligation to do that. Maybe it doesn't have to be the next thing, but
this morning I tried to make a little outline of what an enhancement project
might look like, and maybe we could talk about a few different contexts: the
pharmacology, pre-implantation genetic diagnosis, and then germ line.
mean, there's a little bit of a progression there. One of the people say the
allegation is that the demand for germ line modifications will be enhancement
because if you're focusing on single gene diseases, pre-implantation genetic
diagnosis in almost all cases will provide a way to avoid having an affected
child, and you can still have a biologic child.
So the notion is that the
real market will be in enhancements, and then that would bring in an opportunity
to talk about commercial pressures and industry influence and that sort of
So perhaps to meet Gil's concerns, focus on two or three kinds of
practices, one that goes on today, one that, pre-implantation genetic diagnosis,
goes on today, but it's still fairly new and it will be expanding in terms of
conditions that will be the potential justification for performing it, and then
a future oriented practice where people don't have their established positions,
and there aren't as many stakeholers. So it's easier, perhaps to influence
And I think I agree with Bill. It would serve an important
education function because I do think there's an extreme amount of
misinformation out there about the possibilities.
And then there could be
an ethical analysis of, you know, the concept of enhancement and using those
particular practices as the focus and try to expand that analysis beyond what
exists in the literature now.
We were talking last night about trying to
take a virtue based analysis approach to this. That would be a little bit
different from what's been done.
And then you could look at policy and
regulatory approaches. You could talk about — I think professional regulation
is going to be an important part of any judgments, you know, restraint in terms
of how these things are used.
Individual judgments, how to try to
influence the decisions that people make about when this is appropriate to use.
Even insurance company reimbursement, what should be covered, and then some sort
of regulatory agency that perhaps should influence policy.
So it might be
a vehicle to try to address some of the other topics that we're also concerned
about, and make it a little more focused.
What the genome people are
doing now is they're just trying to put together their five-year plan, and they
are discussing the material they will put out in terms of grants, the requests
for proposals and the ELSI program, the ethical, legal and social implications
program invites grant proposals in those areas. So they're not doing a project.
They're just saying these are the kinds of things we're interested in, and
individuals may decide to do projects on this, but I don't think that they'll be
working through these issues in the way that we would.
CHAIRMAN KASS: Thank you very much. I have Michael and then
Frank. Please, Michael.
PROF. SANDEL: I think we have three topics here, and as far
as major projects, it seems we have time to do two major projects, but there may
be a way to give attention to all three, and so here I have a concrete
On the question of coming up with a proposal for a regulatory
system that would be institutionalized, it seems to me that's something that
this Council can develop, but I don't think it's the kind of topic that lends
itself to the kind of free ranging ethical inquiry of the kind that we have had
and that we're really constituted to engage in.
There are a small number
of our colleagues who are experts in this area, which is really to do with the
details of institutional and structural regulation. There are broad, normative
questions, and Gil mentioned the question of how democratically
But what I propose we do there since it doesn't lend itself
to sustained kind of ethical discussion is to have the people who are experts in
that, namely, Frank and Jim Wilson and Rebecca, work with the staff to develop a
proposal, a concrete proposal for a regulatory structure, and to devote a
session to it here to discuss it.
But the developing of the proposal is
not really something that we as a body are that well equipped to do. Let the
people who are experts in that come up with a proposal, a concrete suggestion.
Let's devote a session to it, and we may find that that's all we need or if we
need to follow up, then that's always open to us.
That would enable us to
devote our attention to the two big ethical questions that are really on the
horizon and that we are equipped as a body to do.
One of the things that
this Bioethics Council is able and ready to do really is to address, as you
said, Leon, not just the bioethics of ends — of means, but also of ends, and
that's really the distinctive contribution that this group can make. And that
suggests two topics.
One is enhancement. And I think we can do that
because if we ignore enhancement, really we're ignoring the central question
about the ends of medicine and science that's before the country now and in the
I think we can address it in a way that makes it
manageable, and I liked Rebecca's suggestion that we divide it into three parts:
drugs, pre-implantation diagnosis, and genes, genetic interventions.
I think we can do that if we take those three categories, do it in a way, and it
will help keep us from veering off into the science fiction aspects, but the
moral — the ethical questions about the ends are going to overlap those three
categories, and I think that would be a fascinating discussion, but also really
initiate a public debate on this question that is looming larger than any other
if we're talking about the ends of science and medicine.
And then the second, which also has to do with ends, has to do with
property in the body and commerce in the body. We don't need to
take commodification as a whole, but if we focus on commerce and
property in the body, we can do it with two categories.
One can be patenting. What should be patentable subject
matter? And the other can be market exchange. What should be bought and
I think we should deal with both of those, not just one of them
because the issues will cut across both, and we can take up those two sets of
questions under property in the body with respect to organs and also genes and
eggs and sperms and stem cell lines, and maybe there are some others.
issues may vary as we look to one or another of those categories, but that's, I
think, the kind of debate that we're equipped to engage in and the kind of
debate that's addressing really the question before the country.
think we should go with our strengths and with the questions that are really
looming largest, and that would be enhancement number one, property and the
body, number two. And we can do regulation, so to speak, on the side.
CHAIRMAN KASS: Response? There's a kind of specific proposal
here that needs reaction. So Janet.
DR. ROWLEY: Well, I obviously have great concerns about
dealing with a topic that calls itself enhancement. I do want to take exception
to Michael's description of medicine as focusing on enhancement because I view
medicine as focusing on the treatment and prevention of disease.
that extent that you call that enhancement, but that's not what the general
population means by enhancement.
PROF. SANDEL: No, I agree with Janet, and if I gave that
impression, that isn't what I was suggesting.
DR. ROWLEY: Okay.
PROF. SANDEL: I was saying that we should focus on what the
ends of medicine are not to be, and I wasn't equating —
DR. ROWLEY: Okay. Well, then I misunderstood. But I guess
faced with choosing between your two suggestions in terms of, say, priority
because they shouldn't be taken up simultaneously, I would be in favor of the
second of your options and maybe putting the first one aside for further
discussion and consideration.
CHAIRMAN KASS: Bill
DR. HURLBUT: I just want to respond to that. I completely
agree with you that medicine is about healing, but let's face it. It's getting
very hard to define what healing is in this day and age. I think more and more
people are turning to medicine with expectations of the metaphor more of
liberation from everything that is not just disorder, but is constraining to
I mean, if you look at — I hate to bring this up again. Leon might
frown — but contraception set a new paradigm for medicine a few decades ago as
interfering in natural life connections. Now, good or bad, that's not the
The point is that is was a change of paradigm, and that is about
to echo forward in all sorts of levels as we gain mastery over biology to where
medicine will become used for achieving the purposes that people think is in the
trajectory of their life expectations or desires or ambitions.
I think we
shouldn't underestimate that, and one of the things, Rebecca gave an order of
topics and it started with drugs. I think maybe it would be better to go
pre-implantation diagnosis, genetic enhancement, cellular enhancement, and then
But the reason I say that is because we are at the cusp of an
astonishing revolution in pharmacology, and particularly I think Paul will back
me up on this, psychopharmacology. We have now capabilities for combinatorial
chemistry that are synthesizing and screening drugs by the hundreds of thousands
in a month where it would have taken ten years to do the same amount a few
decades ago, and the number of protein targets that the genome project is
revealing to us on which we can target pharmaceutical agents is increasing
It's said that up to now we've had 400 to 500 protein
targets. These are the operative sites that our pharmaceuticals operate on, most
of them. We've got only four or 500. Now we're adding some people estimate 1,000
a year and expect to increase that by 1,000 a year for ten years.
you can see how that would be an exponential number of sites of intervention. So
we're looking at a transformed medicine, I think, and I agree with Michael. We
need to get to these issues. The public is thinking about them, and they are to
some extent realistic.
By the way, half of those pharmaceuticals being
developed are psychopharmaceuticals.
CHAIRMAN KASS: Paul.
DR. McHUGH: Well, I found this conversation between the four
of you on the other side extremely useful along the lines that I also said at
the beginning, that we need to move towards a study of the ethics of ends, and I
pick up with Janet and Gil and appreciate the problem of the enhancement arena
simply because the arena goes at a level beyond disease.
I talked to you
at the beginning of this about the elements of treatments that are involved in
the treatment of behavior, treatment of personality and even treatment of the
story of a person's life itself, each one of which medicine has a place to play
in, but makes the problem that Gil first said he worried about, that we might
lose our focus.
On the other hand, I think I absolutely agree with
Michael that this is a vital arena for us to study, and so I would like to
suggest to go along with what Janet is saying that maybe it would be good for us
simply to get our further feet wet into this, to begin with the issues of
property and the role of the body, the issues of the body, the things that we,
as Michael said, trade in the body and even do to the body because we say it
belongs to us.
And after that, as we got that kind of experience of
discussing these things, then we could turn to the issues of enhancement in much
the way it's been said here, and I think we would just be a better prepared
group to come to that.
But these are the two domains that I would support
us to go in as absolutely correct. I very much support that.
I do though
want to say with Michael that even though it might only take a session or two on
what would constitute a proper regulatory body, I think we will have left people
believing that we have not let the other shoe drop since we've been saying, all
of us, saying that this regulatory body is necessary, and that in that way we
would not only be speaking to ourselves, but speaking to the scientific
community that could come to us and support us from their suggestions as to what
they would be willing to live with in regulatory terms.
So I think all
I'm doing is repeating what's been said by the four of you on the other side,
but I want to appreciate the concerns that you show and the sequences that we
would follow would be maturing for us as a discussant group.
CHAIRMAN KASS: Thank you. Charles.
DR. KRAUTHAMMER: I like the scheme that Michael outlined.
I'm troubled by one part of it though, as I have been by Frank's descriptions of
I'm all for regulation, and I'm all for establishing a
regulatory structure, but it begs the question what are we going to regulate
which is a huge issue. I mean it sort of encompasses everything that we're
So it's not as if it's just a technical question. I think
the technical question obviously is doable. A subcommittee working with staff
would be a great idea, and I don't think there'd be a lot of discussion. People
know what regulatory structures work, which ones haven't. There's history on
But the real issue in regulation is what are you going to regulate.
We just spent six months on whether or not and how to regulate cloning, which is
one issue out of hundreds.
So I'm not sure it will advance us a lot if
all that we establish is a chart with the lines of authority. We'd have to
discuss what's going to be regulated and to what extent.
So I think in
other words, I'm not sure it's disposable unless it's a merely technical issue
of establishing a body. If it's larger than that, it's a topic that could
consume us for 18 months.
PROF. SANDEL: But that might be a reason to have them do the
technical work and then address the thing after we do these two topics having to
do with ends.
DR. KRAUTHAMMER: But it's not clear that you can do a
generic box structure and then apply it to whatever you decide you're going to
regulate later. It's sort of chicken and egg here, and I'm not sure how you go
ahead with it.
Perhaps the regulation part ought to be the last thing
that we do at the end of our term when we've looked at what we decide has to be
PROF. SANDEL: Yeah.
DR. KRAUTHAMMER: Cloning and sale of organs and patenting
and gene enhancement or whatever enhancements, and then say, well, these are the
new issues of the new medicine. Here's the structure and here's how it would do
Does that sound okay to you, Frank?
CHAIRMAN KASS: Well, Frank, go ahead.
DR. FUKUYAMA: Well, I think what Michael said is perfectly
right. I don't think this Council can just take up this issue without any
preparation, and so actually my thought was that the extremely able staff of the
Council, which was able to come up with this thick report on cloning in six
months could come up with, you know a similar draft document that wouldn't just
deal with a narrow technical issue, but would actually lay out a series of
choices in terms of regulatory options.
For example, do you want to just
regulate cloning or do you want to spread it to regulate the whole of IVF and,
you know, reproductive medicine in general?
I mean, so there are a lot of
choices that the staff does not have to take a position on, but at least those
kinds of choices could be made.
And I would agree that, you know, the way
I would envision this is that, you know, the staff go to work. I'm happy to work
with them. I'm sure Rebecca and Jim Wilson will as well.
I'm trying to
get foundation support to basically be working on this, you know, to mobilize a
bunch of people to work on this here in Washington anyhow in the next couple of
years, and to come back in maybe nine months with a draft document.
guess what I don't want is just that it be one of these tabs, you know, in one
of the briefing books that we discuss for one session. I mean, what I imagine is
that it will be like the cloning report. I mean it will be another major, you
know, kind of product that will come out of this Council toward the end of its
PROF. SANDEL: Then for the reason Charles raises we have to
discuss the ethics of each of the practices that would be subject to the
regulation, which suggests it should be at the tail end of this because we won't
have delved into all of those topics.
CHAIRMAN KASS: Yes, and there's, first of all, the subject
matter question, and there's also a question of if one wants to offer
suggestions that might, in fact, be taken seriously. One really has to be
dealing and having a fair amount of input from the people whose activities one
is threatening to regulate, and that means, in part, the scientific community,
but it also means the industry because the academic scientific community
regulates itself in a variety of ways.
And that means if one wants to try
to be helpful here, one really has to think about arrangements that would
produce the incentives for everybody to play rather than to treat this as police
work. That's not a modest undertaking for, you know, armchair guessing. That
means sitting down with people and doing it thoroughly and carefully.
can't come out as the end product without an awful lot of work in advance. The
importance of it I recognize, but one needs to go — even to get started on it,
one needs, you know, a serious working document on what it would mean to do this
right and not simply to call for doing it without having sort of laid that
And I'm not sure that the staff at the moment has the expertise in
this area. The staff has a willingness in this area, but it would have to be if
we were going to do this, either we would have to go and get some particular
additional staff to work on this or we would constitute a subcommittee of the
Council that staff could assist in the preparation of something like
But unless I misunderstand our resources, you can't simply say, "Go
and design alternatives that we can then talk about." I mean I think you really
have to — I mean, I'm not telling you anything you don't know.
setting up a year long or two year long intense study of this for that reason,
and maybe we could work with you in that group.
PROF. SANDEL: Yeah, some of this could be done in the work
of Frank's group, and then you could connect it to the staff.
CHAIRMAN KASS: Yeah. Gil. We're going to bring this to a
close because I don't want to keep the public session waiting.
Gil, go ahead.
PROF. MEILAENDER: Yeah, well, I just note with respect to
this, I mean, it's not impossible for a body like this to commission work —
CHAIRMAN KASS: Absolutely.
PROF. MEILAENDER: — from others, too. I mean, so it doesn't
have to be a subcommittee of us or the staff. We can do that.
point, I still would like us to think — I'm not sure that I have the same —
let me put it this way. I'm not sure that I have the same notion of what we're
best equipped to do. I have to say the last six months has been a sobering
experience in that regard, and I think we should think about that.
mean, we tried to study and speak almost simultaneously in the last six months.
We were talking and writing at the same time. I would just like somebody, you or
somebody, Leon, to think about whether that's really the best way to
And I'm not persuaded that it is. That's all, and to start on
another big project that we did the same way, well, I would just want us to
think about that before we did it.
CHAIRMAN KASS: A couple of comments, and then we'll —
DR. KRAUTHAMMER: I was just asking what's the alternative to
studying and speaking?
PROF. MEILAENDER: The alternative is to study for — I mean,
one can study for a long time before one tries to speak or one can say at the
outset, "This is what we're going to speak about. Now let's do it."
see, you can either think you know from the start what you want to say and then,
as it were, "write" to it, or you can be entirely agnostic about what you want to
say and just wait to see what emerges.
And I'm not sure that one or the
other of those might not work better for a body like this.
CHAIRMAN KASS: Alfonso — do you want to respond directly to
PROF. GLENDON: If I might.
CHAIRMAN KASS: Please.
PROF. GLENDON: Unfortunately I'm going to have to leave, and
I do apologize for that, but I did want to say that I find myself in some
confusion after having listened to the comments, and I'm mindful of the fact
that we won't meet again for two months.
CHAIRMAN KASS: Right.
PROF. GLENDON: And I personally would benefit if we could
have an exchange of e-mails, if we could send in our thoughts.
CHAIRMAN KASS: You read my mind. That was going to be
This is an inconclusive conversation. There's lots here,
but because I might forget after Alfonso speaks, an assignment, please. Follow
up on this conversation from as many of you as can do this in the next couple of
weeks, if we could have your thoughts about future directions, with the
understanding, of course, that people think about things that happen in the
meeting afterwards and might come to a different conclusion having thought about
So please —
PROF. SANDEL: Could I just say a quick word of reply to Gil
about the virtues of studying and speaking at the same time? I think that the
discussion now — Gil may feel that I should have studied more before speaking,
but I think that part of the exploratory quality in the animation of the
sessions we had reflected the virtues of studying and speaking and exploring
even before we had sort of necessarily taken positions or thought things through
And so I think there is some energy in that kind of
deliberation that I think has been a strength of the group.
CHAIRMAN KASS: Thank you. Alfonso, and then we will break.
Mary Ann, thank you.
DR. GÓMEZ-LOBO: I just want to express a few perplexities.
I'm not making any solid contribution here.
It's clear to me that Charles
is right, that any discussion of regulations and, therefore, regulatory
authority has to come after we have a clear idea of what we're going to regulate
and according to which principles.
Now, the two great topics, enhancement
and commodification of the body, with regard to enhancement, I must confess that
I'm very much at a loss philosophically as to how to tackle the problem. That's
why I kept my mouth shut yesterday when sports were being discussed because I
really don't have a view of where the principles of the criteria are going to
And that induces me to think that it might be wiser to start
with the discussion of property in the body because in a way, I think there are
certain traditional principles that give us some sense of
For instance, it strikes me as defensible that one should
not, say, give patents over human beings, for instance, I mean, for reasons of
human dignity, et cetera, et cetera.
Now, that should extend to different
ages, different stages, et cetera. So I confess that I see some way of pursuing
that topic. I see no way at this moment of pursuing the enhancement topic, and
that would be a good reason for me and for others to sit down and try to think
about it in terms of ultimately what the ends at stake are, as Paul was