December 2, 2004
Session 4: Biotechnology and Public Policy
Council Member Francis Fukuyama
PROF. MEILAENDER: Well, why don't we get started.
This is a session on biotechnology and public policy, the first
of two sessions devoted to questions of regulation. The Council
has, since its very first meeting, had an interest in this topic.
It's, in fact, an interest that we have followed almost throughout
our entire course.
And the question — the large question that underlies that
— those discussions and inquiry is: can we find ways to govern
for the good the uses of these novel and challenging biotechnologies,
repeating their benefits while at the same time upholding human
freedom and dignity.
We've issued a report on this subject, Reproduction and Responsibility.
It is, in important respects, an interim report. It was primarily
a diagnostic document, though we did make recommendations in the
interim, while suggesting that the conversation had to continue,
about which of the various possible regulatory models might be most
And we have today and tomorrow morning two sessions that constitute
part of this Council's continuing inquiry into that topic.
Tomorrow morning we are very fortunate to have two members of the
Canadian government — Health Canada, Ian Shugart and Glen
Rivard, who are here today — welcome to you — and they
will tell us tomorrow about the very interesting new system that
Canada is instituting following legislation passed earlier this
We heard something about this way back from Patricia Baird, who
was part of the original commission that was looking into this.
But these gentlemen have had a hand in actually getting the legislation
through and implementing it.
Today we are privileged to have a presentation from Frank Fukuyama
and his colleague, Franco Furger. Welcome, Franco.
Frank, more than any other member of this Council, has been devoted
to this subject. He is in a way the spark and the father of our
inquiry. I think everybody knows that he has also, with support
from foundations, been conducting his own seminar over at Johns
Hopkins. I and several members of the staff have been privileged
to sit in on these meetings. As Frank will tell you himself, this
work is the work of the two of these gentlemen. We present it here
not because it represents the thinking of this Council but because
it represents important thought that should be brought to this Council.
And we hope that the conversation will help your project and that
this presentation will help us in continuing to think about this.
So the floor is yours, and thank you very much.
DR. FUKUYAMA: Well, thank you very much, Leon, for giving
us this opportunity to talk about our project on biotechnology regulation,
and we appreciate you and the staff attending our meetings over
the past 18 months.
The presentation we're going to give you today is going to
be a little bit different than the slides that are in your briefing
book. We are going to skip over the description of the existing
regulatory framework, because that was actually quite adequately
covered, excellently covered in the Reproduction and Responsibility
Report that the Council issued. So I think you are quite familiar
with a lot of that.
We do have an Executive Summary of about 25 pages. If Council
members would like to see a copy of that, we will be happy to give
it to them. We're not releasing it publicly at this point,
because we wanted to get comments from our study group first and
I hope within the next month we'll actually have something
ready for public release, and the full body of the study is really
a massive — it's really more of a book than a report,
several hundred pages, that covers the regulatory waterfront quite
I would like to pay special thanks to Franco Furger, who is seated
to my left. He has really been the driving force behind this project.
He has drafted most of the report, and the real research and work
of putting together both the study group and the report itself are
really — are really due to him.
It's entitled "Beyond Bioethics," because it was
our feeling for some time that the model that was settled on in
the 1970s where the scientific research community and certain areas
of biomedicine were left largely self-regulating, with advice from
bioethicists on the ethical dimension was no longer adequate to
meet the demands of the technologies, the ethical challenges that
the technologies would put forward, and that we needed to talk about
the R word, the regulation word, much more explicitly. And that
is really the subject of the talk today.
Go ahead, Frank.
Now, the project has been running for the past 18 months. We've
had a series of about 11 study group meetings involving —
not all of these 39 members came to every meeting, but we tried
to get all of the major stakeholders that had an interest in the
broad area of biotechnology, reproductive medicine, from, you know,
the biotechnology industry organization to members of the President's
Council, and a lot of scientific groups representing scientific
research communities of various sorts, and the like.
If you are interested, we also have a website and a regular newsletter
that reports basically on regulatory and legal issues related to
human biotechnology. And you can sign up for the newsletter. You'll
get it automatically, or you can go to our website.
The study group members are being asked to comment on the report,
but the — when I say "we" in the subsequent presentation,
the "we" just refers to myself and Dr. Furger. The members
of the study group were not asked to actually endorse the contents
of the report.
This is just a screen shot of our website. It's quite involved.
It really has quite a lot of sections, so I really do invite you
to — to take a look at it.
Okay. Go ahead.
This is an overview of what we're going to be talking about
this afternoon. We're going to define the domain of inquiry,
say a few preliminary things about regulation. We are going to
talk about the ethical principles that motivate the desire to regulate,
and then we're going to — actually, we're going to
drop out most of that last point, regulation in other developed
countries, except to talk very briefly about Britain and Canada.
We'll obviously hear much more about Canada tomorrow morning.
And then, finally, pros and cons of alternative approaches, which
range from basically the status quo to creating a new regulatory
institution. We opted for the option of a new institution, but
we really did want to try to be judicious in our consideration of
different kinds of approaches, and then to define what a new institution
might look like.
It is basically an independent agency, of which there are many
scattered around Washington, but we believe that we need some innovation
in incorporating new mechanisms for public participation. So we
will describe this in much greater detail.
Incidentally, this is, you know, in a way an issue that all regulatory
bodies, both national and international, have been struggling with,
because there's a feeling that the old mode of top-down formal
regulation is not adequate to meeting the — you know, the
demands of kind of popular participation and the solicitation of
kind of ownership by the people in the society, the broader society
that the regulators effect, and so it comes up in a lot of different
contexts, not just in this biotechnology one.
And, finally, we're going to say very briefly something about
constitutional constraints and some international considerations.
Now, the domain of inquiry is very similar to the one that was
defined in the Reproduction and Responsibility Report. It's
technologies and medical practices related to human reproduction,
not necessarily those that had the intention of producing a child,
but ones that were related to it, and that includes several areas
— the practice of medicine involving artificial reproductive
But it also includes scientific research in the area of stem cells
and research cloning. Obviously, stem cell research does not aim
at reproduction. But since the embryonic stem cells come from embryos,
it obviously is related to the whole area of reproduction. So our
interest is in covering that. I don't think you can really
separate the two of them out.
And just to indicate the kinds of technologies we are talking
about, it's things like prenatal genetic diagnosis and screening,
reproductive and research cloning, if germ-line modification becomes
possible in the future this would fall under this category, novel
forms of reproduction of the sort that were mentioned in the Reproduction
and Responsibility Report, you know, the fusing of embryos, the
walking back of, you know, adult stem cells to oocytes, a lot of
the things that seem to be in the pipeline right now.
Now, we thought that we ought to lead with this, just to clarify
where we're coming from on this topic that we and this Council
have discussed at great length in earlier years. Obviously, it
is very difficult to talk about regulation without getting past
the issue of the status of the embryo.
I think that the — the controversy over this may well make
our effort difficult, if not impossible, to actually accomplish
in this society. And as you'll see, I think it will require
a prior consensus on resolving this issue. But just to put our
cards on the table, we start from the position that's been defined
in this Council as one of, you know, believing that embryos have
an intermediate moral status, which means that we believe that both
embryo and stem cell research are legitimate activities and can
What to me "intermediate moral status" means is that
embryos do not have the moral status of infants, but they are also
not simply clumps of cells, and need to be treated with a certain
degree of respect. And in our view, what that means, among other
things, is that they cannot be disposed of or used, except for the
most important and serious ends. We do believe that stem cell research
is one of those ends that is legitimate.
I would just make a — you know, an analogy. I think there's
another category of objects that have this similar intermediate
status, which would be dead human bodies, cadavers, which are, in
fact, instrumentally used in medical training and other things,
but you cannot casually dispose of them. We pay a certain degree
Now, I don't want to — I certainly do not want to provoke
an argument over this. I'm just — this is in the interest
of full disclosure. This is really our starting point and the premise
with which we begin this regulatory project.
Now, some general considerations about regulation. I think it's
quite appropriate to be very cautious about calling for excessive
regulation, because whatever you regulate you obviously get less
of. And we, above all, do not want to stifle innovation and growth,
and, therefore, we think that those that want more regulation ought
to really demonstrate quite effectively why that is necessary.
On the other hand, I believe that in the current climate in the
United States right now, if you actually want to make progress in
something like stem cell research, it is extremely important to
think seriously about the appropriate institutional regulatory framework
under which it can be done successfully.
There's a clear example of this. The British Human Fertilisation
and Embryology Authority is an extremely strict regulator of embryo
research in the United Kingdom. Every embryo that is produced in
any fertility clinic in Britain is tracked and registered by the
HFEA. So it's a much stricter regulatory regime that exists
— than certainly the one that exists here in the United States.
On the other hand, it is perfectly compatible with a vigorous
stem cell research effort in Britain. Britain is one of the leaders
in this area, and I would argue that if the United States wants
to be a leader it — it needs to do that also.
I mean, it needs to give serious thought to the regulation, because
the regulation will present abuses happening that are consequentialist
abuses of the — I mean, if you think that stem cell research
is legitimate, but you are worried about the further, you know,
moral slippery slopes that come from it, I think that you absolutely
need a regulatory framework to put some firewalls against those
kinds of possibilities.
I'll just give you this brief analogy to what we think we're
doing, or the kind of juncture we think we are at historically.
In 1887, the Interstate Commerce Act produced the Interstate Commerce
Commission that existed up until I think 1995 or so, which was to
regulate railroads in the United States.
The Hepburn Act, in 1906, gave trucking regulation to the ICC
on the grounds that trucks simply moved goods over state boundaries
just the way railroads did. And I think most experts in administrative
law felt — have felt in retrospect that that was a really
big mistake, because the economics and the politics of trucking
and railroads were sufficiently different that the expertise did
not transfer over.
And, therefore, when civil aviation came into being in the 1920s,
the United States did not give civil aviation regulation to the
ICC, which conceptually it could easily have done. It created agencies
that eventually became the Civil Aeronautics Board, and the Federal
Aviation Authority, too, as new, independent regulators.
And that's really our argument. I mean, you could use the
existing regulatory system in the United States to carry out some
of these tasks. But it is our view that given the narrow mandate
of the Food and Drug Administration and the National Institutes
of Health, we do not think that that is an adequate basis of doing
Now, in your briefing books, you — oh, I'm sorry, we're
not quite at that point yet. All right. Let's go ahead.
All right. Now, this is — this next section is going to
talk about the ethical principles that we believe motivate our desire
to create a new regulatory institution. Obviously, you can't
say that you want to regulate something unless you have some idea
of the goals or the goods that you are going to try to achieve.
And so we're actually going to steal a page from the —
you know, the Canadian approach to this that you'll see tomorrow
morning and begin with, as they do, a statement of principles, although
our principles are a little bit different. And then, the principles
generate a list of activities that we believe ought to be prohibited
outright, as in the case of the list that was in the Reproduction
and Responsibility Report, and then a series of activities that
we believe are legitimate but need to be regulated.
General ethical principles — again, this will seem very
familiar to members of this Council. We put well-being and the
health of children at the top of the list, above the right —
we think that access to ART on the part of infertile couples is
an extremely important social good.
The million children produced by IVF have been, you know, a great
blessing to those people, but we believe that the well-being of
the children that are produced by this technology has a higher,
you know, ethical status than the desires of the couples involved.
You know, many people would say that those are indistinguishable,
because parents want healthy children.
They want the best for their children. And, therefore, what they
want, you know, is a good proxy for the well-being of the children,
but in our view that's not always the case. It is largely the
case, but there are many instances you can imagine in which the
interest of the parents in having an offspring may outweigh the
well-being of the child produced. And by "well-being"
we do not simply mean health in a kind of narrow physical sense.
We mean psychological and social well-being as well.
As you'll see in the statement of prohibited activities, you
know, our interpretation, like that of the Council, of what "well-being"
means, it means among other things being related to a — biologically
related to a mother and a father. And we believe that technologies
that, you know, create children that do not have that relationship
do not adequately take into account the — you know, the ultimate
psychological and social well-being of the child.
The third principle, the well-being and health of women, is obviously
important because there are certain risks that women take in artificial
reproduction. They are not borne by men in terms of need to —
you know, for hyperovulation, and so forth. But we put it below
the first two principles simply because it's done voluntarily
on the part of the women that undergo the treatment.
And then, the next two are fairly self-explanatory — free
and informed consent. Again, as the Council pointed out in the
R&R Report, you cannot have free and informed — I mean,
you know, a lot of IVF, as it moves from the laboratory into clinical
practice, really does amount to a form of human experimentation
in which you can't really get the consent of the ultimate subject
of that experimentation, which is the child.
And it puts a special burden I think on information-gathering,
and so, of course, the — you know, the R&R Report's
recommendation for funding of better longitudinal studies of the
health of ART children I think is really critical here and implied
by that principle.
Finally, a principle that we would add is that we believe therapeutic
overenhancement uses of biomedicine ought to be emphasized in any
regulatory scheme. Of course, you know, we've been through
— since the Council wrote an entire study on this subject,
we don't have to rehearse this. But despite the fuzziness of
the distinction in many cases, we think that it's still one
that is extremely important to hold on to.
We don't believe that we need to ban or prohibit enhancement
uses of biomedicine. I don't think we would want to. But certainly
a regulatory system can bias things heavily in favor of therapy
overenhancement in terms of the relative costs and the barriers
over which you — that you have to overcome in proving the
— you know, the safety of procedures, and the like.
Now, this statement of principles translates into several targets
of prohibition — again, very familiar territory. Reproductive
cloning, creation of chimeras and hybrids, we — you know,
again, as the Council did — make exceptions for certain, you
know, research chimerism. But we think that, you know, creating
a chimera with an object of reproduction is something that simply
should be banned outright.
Germ line, because we don't see any way that this can be done
safely now or in the foreseeable future, again, the new reproductive
possibilities that alter the biological relations of parents and
children have to do with, you know, things like fused embryos or
these new technologies coming out of stem cell research that would
produce children that — you know, that did not have this relationship
to a mother and a father, and then limits or a prohibition on the
patenting of human embryos.
Now, the issue that would be regulated: we believe that we should
permit research cloning, but that it should be carefully regulated.
Now, this is obviously a choice that many people would not make.
I would point out that, as you'll see shortly, the difference
between the British Regulatory Agency and the Canadian Regulatory
Agency — in most respects they are identical institutions
with very similar kinds of goals, but they differ in this one —
on this one issue.
And you could create a structure of the sort that we are proposing
that would actually prohibit research cloning, and would still do
all of the other things. So, in a sense, I don't want people
to get too hung up on the fact that we believe that this is legitimate
and simply subject to regulation.
But we also clearly believe that PGD ought to be regulated, biomedical
research involving early stage embryos, blastocysts, the kinds of
things like limits on, you know, the stage of development beyond
which research is legitimate — these kinds of issues —
sex selection and commercialization of other elements of human reproduction.
We don't think that there should be a completely free market
in the, for example, in the sale of gametes.
Now, we've skipped over — you'll see the slides
in your briefing book. We had some focus on the British and Canadian
systems, but this Council has been over this. This chart —
in the full study, we have a comprehensive listing of every international
piece of legislation in this area over the past decade or so. It's
an extremely long list. This is just illustrative of some of the
legislative initiatives that have been undertaken.
Four countries — Canada, Australia, the UK, and France —
have actually set up new regulator — regulatory institutions
in the last decade of the sort that we are proposing to do. And
virtually every other country, developed country, has passed legislation
in this area. And in this respect, the United States is a big outlier.
We are really the only developed country that does not have legislation,
for example, even on the narrow subject of cloning in place. And
many other countries have been considering this, so this is not
an outlandish proposal. It may be outlandish in the context of
American politics, but certainly, you know, when we compare ourselves
to even our Anglophone peers, we are very slow at working to this
Just very briefly, to give you a preview of what you're going
to hear tomorrow about the Canadian system — again, this just
emphasizes that the Canadian Assisted Human Reproduction Agency,
this new agency that was just created by the Assisted Human Reproduction
Act this year, sets up a new agency very much modeled on the British
And they do very similar sorts of things, or at least they intend
to do very similar sorts of things. And, again, they differ in
this one area: that the HFEA permits reproductive cloning —
I'm sorry, there's a mistake there. I'm sorry, under
Britain, it's reproductive cloning permitted, not prohibited.
And Canada, reproductive cloning prohibited. Yes.
No, I'm sorry. No, that's right. No, that's right.
They're both — I'm sorry, I was getting the wrong
— yes, right. The research cloning is regulated. Sorry,
All right. Now, we're going to run briefly over — I
think we've got four major baskets of alternatives of how to
proceed with regulation. One is simply to use the existing statutory
powers that exist in the FDA and NIH and the various state agencies.
You'll see in the slides in your briefing book we go over
all of the existing powers — I mean, you know, just very brief.
Well, so that's one alternative — to take those existing
statutes and reinterpret them creatively to give the existing agencies
powers to do some of the things that we want to do. That's
The other is direct legislative intervention. There are a number
of cloning bills in — you know, that have been introduced
into Congress. There's a lot of state legislation in this area,
including, you know, most recently Proposition 71 in California.
Self-regulation is an existing practice, but it is something that
could be beefed up in many respects. And then, finally, our preferred
option, which is to create an entirely new regulatory authority.
Now, in terms of using existing powers, obviously it's hard
to measure the cost of new regulation. But if you go with the current
system, you're clearly going to avoid a lot of direct costs
of creating the new authority, and then the more important indirect
costs of the opportunities forgone by the fact that you're limiting
both scientific research and medical practice.
And the FDA has, for example, sought to regulate reproductive
cloning by arguing that basically human embryo is a biologic that
falls under their statute as something that they can regulate.
We think that there are a lot of problems with this approach, major
gaps. Again, people should be quite familiar with this.
The FDA, you know, only regulates drugs, medical instruments,
and biologics. And it's a lot of creative, I think, legal argument
that says that an embryo is actually a biologic. We have heard
from quite a few lawyers that think that this would not really stand
up to a court challenge.
And in that respect, you know, the NIH can — you know, in
a sense has broader powers to regulate — on the basis not
simply of safety and efficacy, and not simply those three categories
of products. But also, you know, can make decisions on funding,
you know, embryo research and the like, which it has done. But
it only covers federally-funded research, and really does not cover
the private sector at all.
And, finally, there's an issue that Jim Wilson, among others
has written, you know, very perceptively about in the past, which
is that regulatory agencies that are created for one purpose not
only have formal statutory powers, but they also develop a kind
of bureaucratic culture that is oftentimes very difficult to change.
And so if you give it a substantially different mandate, in this
case the mandate to consider certain kinds of ethical issues in
addition to safety and efficacy, a lot of times it's just very
difficult for the — you know, the old institution to adapt
to these new requirements.
Now, direct legislative intervention. Obviously, Congress, if
it passes a law prohibiting something like reproductive cloning,
can speak much more authoritatively. And I think it's important
to point out that we would not — we do not believe that something
like the status of the embryo, the moral status of the embryo, is
an issue that can be delegated to any regulator. That's obviously
a very controversial and important ethical issue. It needs to be
decided by the society and not — not delegated. And when
Congress does speak, you know, we know, really, where the American
On the other hand, we believe that in the future there are going
to be lots of very tricky decisions that will be put forward by
new developments in technology that Congress simply does not have
the expertise or the time to legislate specifically on.
And even if they were to legislate, we don't believe that
this is a good idea, because, you know, this kind of direct legislation
is too — you know, it's a big hammer, and you need, I
think, a more delicate instrument to make some of these kinds of
For example, the current cloning bill, just as an example of the
inadequacy of the current direct legislative proposals, the S. 303
is a bill that was put before the Senate that would ban reproductive
cloning and permit research cloning, human embryonic stem cell research
But we believe that if you read the bill carefully, it is completely
inadequate in terms of the regulatory oversight that it —
it provides. It basically says that any new protocols have to be
given to an IRB. And for reasons that we detail in our longer report,
IRBs currently, as set up, are simply not capable of making decisions
Proposition 71 is even worse. I mean, this was a proposition
that was deliberately designed to strip out as many institutional
constraints on scientific research as possible. I think it's
safe to say it's kind of like turning over the henhouse to the
foxes in a certain sense in terms of the governance structure.
And so what we're trying to do is — is think through
seriously, if you didn't want to do that, what would a regulator
Self-regulation — this exists right now. ART is self-regulated
by ASRM and SART, the two major associations that represent the
ART practice of medicine. And, again, this is repeating stuff that
was in the R&R Report.
We really don't have enough information in a certain sense
to know fully how effective it is. Certainly, there are limits
to what self-regulation can do. The other thing that's important
to note is that there is no clear dividing line between regulation,
formal regulation, and self-regulation. All formal regulation ultimately
requires cooperation, substantial cooperation, on the part of the
regulated industry. That's where all the knowledge of what's
going on comes from.
And in many ways, the most effective forms of self-regulation
operate in the shadow of the possibility of formal regulation.
And so I don't think that it's sufficient to, you know,
simply throw up self-regulation as a clear alternative to a more
And, finally, our choice for the reasons stated: in order to incorporate
ethical decisionmaking or ethical considerations into the regulatory
decisionmaking, we believe that you really need a new institution.
And also one that will deal explicitly with the question of interest
group capture and deadlock.
And, again, you know, the flip side of this is the pros of sticking
with the current system, the opportunity cost of creating this new
institution. Now, we're going to go on to talk about what that
might look like, if we did number 4, alternative number 4.
Our proposal is modeled on both the British and Canadian authorities.
The central design criteria is the need to avoid capture of the
agency or of the polarization within the agency between various
single-issue interest groups, so that it will simply not, you know,
serve the interests of, let's say, the biotech industry or the
— you know, the ART practice of medicine. It cannot also
be held up, you know, simply by — by pro-life groups.
Now, the rationale for doing this is really based on our understanding
of where the American public is as opposed to the interest groups.
You know, there is a — in the discussion of public choice,
there's this kind of debate over what constitutes the public
interest. And for many people, public interest is simply, you know,
all of the existing well-organized interest groups that show up
at a public hearing.
And for reasons that we will detail in the next few slides, we
do not believe that this is an adequate approach, because we think
that the existing interest groups, particularly in this area, actually
are not representative of the American people at all. They are
much more polarized and represent a much narrower set of views than
the American public generally.
And, therefore, we take a new approach in which we give statutory
power to a new independent agency that will be constituted to be
able to incorporate this kind of ethical decisionmaking.
Obviously, it will be based on the expertise and with respect
to the scientific researchers and the — the — you know,
the biomedical practice in reproductive medicine, but will also
reflect broader societal concerns. And, therefore, it is very important
in the design of this agency to have new mechanisms to encourage
We think that the current deadlock over cloning, in which there
is, you know, general agreement that we want a ban on reproductive
cloning, but are very divided on research cloning, which has then
prevented the emergence of any legislation whatsoever, represents
a kind of political failure in this country that other countries
have not been subject to.
And we think that this actually does not reflect the interests
of the American people, as far as we can tell, through empirical
evidence. And to demonstrate this, if you look at — and we
cover a great deal of polling data in our study — if you look
at what the American public thinks about research cloning, they
are not terribly sympathetic to it in the way that the scientific
research community is.
For example, if you poll Americans with a kind of neutral formulation,
in which you balance the rewards from research cloning against the
fact that you are destroying embryos, basically you get a two-to-one
And, obviously, you can stack the results of these polls depending
on the way you ask the question. So if you talk about the benefits,
you get to a 50/50 split in the American public. And if you mention
only the destruction of embryos, you get much higher opposition.
But the balance formulations really lead to general opposition,
which means that the American public is really not at all where
the scientific research community is on this issue.
On the other hand, if you look at something like stem cell —
embryonic stem cell research, using excess embryos, I think it is
very clear that there's a very large majority of the country
that is in favor of doing this. You look at the Harris —
the first Harris poll for 2004, 72 percent of Americans support
this kind of research, and only 13 percent are opposed to it. And
that — you know, and public opinion has been moving in that
direction as we have debated this issue.
And, therefore, the current policy is not one, you know, at least
according to this poll data, that is generally supported by the
public. And what this I think is meant to illustrate is that, in
fact, the current polarization that exists in Congress and in the
debate on the part of the interested, organized groups, is actually
much more polarized. You know, the American public occupies a much
more centrist position, and I think one that would actually support
our proposal to permit, for example, stem cell research, but under
strict regulation. Much more than actually any of the existing positions.
All right. So the problem of institutional design is to make
the institution both independent and representative, and I suppose
you should add effective, and capable of making actual decisions.
So we have a kind of two-tier approach to doing this. The actual
power to make decisions will be vested in an independent agency.
The way that these are designed, you know, comes down to things
like appointment terms and voting rules. In many independent agencies,
the President appoints members of, you know, the agency or commission.
They serve for fixed terms. They have to be approved by —
you know, by the Senate.
We have a detailed discussion, which, you know, we can discuss
at greater length if you want in the question and answer session
about how we think we ought to approach the creation of the board
of this agency. But our view is that it should not simply represent
the existing groups, that we should — you know, that the President
ought to use his discretion in this to seek as many independent
commissioners that are not clearly associated with — you know,
with that approach.
The second tier of this is an advisory function that has to do
with mechanisms for public consultation. Now, existing administrative
law provides for this already, and it's built into a log of
regulatory agencies. The Administrative Practices Act from the
1940s provides for notice and comment, which is, you know, routinely
done on — when an agency wants to promulgate a new regulation.
We think that this is not really an adequate, you know, approach.
Generally speaking, agencies, by the time they post a rule for notice
and comment, have already actually gone through a consultation process
with a lot of the stakeholders, and very little tends to happen
as a result of the — the public input at this point.
Again, public hearings are built into a lot of decisions on, you
know, things like toxic waste management, you know, nuclear —
sighting of nuclear sites and the like. And, again, the actual
empirical record of public hearings having, you know, major impacts
on — on decisions is — tends to be limited.
There are some newer mechanisms like consensus conferences and
citizens' panels. A consensus conference is a relatively small
group of citizens that are chosen to be somehow, you know, broadly
representative of the public, who actually sit — they are
given information, they are brought up to speed on the nature of
the technology — and then they sit down in a small group and
discuss that, and try to come to a — you know, a decision
on, you know, what the appropriate regulatory response ought to
It's an interesting procedure. It's used in — you
know, in the United States. I guess the NIH has used it in environmental
law, and other places. It's used very extensively outside the
United States, in Denmark particularly, in Japan, in Switzerland,
in other countries.
The big problem with this is that if you empanel, you know, one
— one consensus conference of 20 citizens, you have to wonder,
even if they come to a consensus decision, you know, what that represents,
because, you know, it's just 20 citizens. And so, but it is
something that has been used in rulemaking in — you know,
in other cases.
And there are lots of precedents, you know, for — for all
of these measures — public participation measures. At a federal
level, most of these are in the area of environmental law.
We believe that we really need public participation as a buffer
against interest group polarization, but that then represents —
you know, raises a question of who should you consult, or who are
the real stakeholders? And as I said, many people — the answer
to that would be, "Well, whatever interest group simply shows
But, you know, there's been a lot of writing on the participation
of NGOS and interest groups in this kind of regulatory decisionmaking.
I mean, it exists both at a national level and at an international
level where there are all sorts of proposals. You know, the UN
already incorporates a lot of this sort of thing, of consulting
NGOs and their various proposals to have this incorporated into
It is very problematic in a lot of respects, because NGOs, you
know, claim to represent the public good. But they — you know,
they may or they may not, and they're not accountable. They
do not, you know, have clear rules. There is no way of knowing
whether the interest groups that actually show up are, in fact,
broadly representative. There are plenty of cases where you get
very good decisions, regulatory decisions, that are nixed by a very
unrepresentative NGO that just happens to be very well organized
And so we — you know, we think that this is not an adequate
approach. And so, therefore, in a sense we need public consultation,
but one that has to be much more, you know, guided in a sense, you
know, to avoid — to avoid that kind of problem.
There's a further problem in this particular area of scientific
literacy, because, of course, there are big problems with simply
how much the public knows about, you know, particular issues. You
know, it turns out that people don't understand the difference
between reproductive and research cloning, and the like, and then
they change their attitudes once they discover what — you
know, what the difference is.
And so, obviously, you know, to say that you're going to consult
the public means that they have to have a certain basic, you know,
degree of information about the technology. And then, finally,
you would like the consultation to be deliberative, so that it's
not simply polling existing, you know, strongly-held preferences,
but in a way the shaping of preferences through a kind of discussion.
Again, there are problems with this, because sometimes deliberation
doesn't lead to consensus. It actually leads to greater polarization.
I don't know that there's a clear institutional solution
to this, but it is a danger of this approach.
So this is our proposal, I guess in a nutshell. The independent
agency structure to require — I guess there are constitutional
constraints on whether the statute can actually require this kind
of balance, but certainly it would be a recommendation to the President
in terms of the appointment of, you know, the Commissioners to achieve
a kind of balance and independence on the part of the Commissioners.
And then, public participation mechanisms — and this is
the part that I think really is new and does not exist in any existing
regulator in the United States right now — deliberative panels.
For example — essentially, what it does is take a —
a consensus conference, and simply multiply it. So that instead
of having one consensus conference, you may have, you know, a couple
dozen or even larger.
I mean, there have been cases that have been sponsored, you know,
not — not in terms of government rulemaking, but in other
areas, where you empanel a lot of panels that are designed to be,
you know, much more broadly representative by the usual criteria
of geographic representation, age, gender, occupation, socioeconomic
status, and the like. These can be supplemented by various forms
of targeted surveys.
We think that, you know, the internet and new forms of technology
— communications technology, give you also certain other opportunities
for public consultation. That's what the consultative college
refers to, which is instead of bringing people together and empaneling
them for, you know, in effect a town hall meeting, you can have
kind of ongoing discussions that, again, will have to be carefully
managed by the agency, but with the purpose of eliciting both deliberation
and, you know, solicitation of public views.
Constitutional constraints. I mean, I think the issue has been
brought up by a number of people that if we actually wanted to create
this kind of agency, it may fall afoul of some constitutional issues
having to do with procreative rights.
We don't believe that this is the case, because we think that
the courts are likely to recognize a much more traditional understanding
of any right to any procreative rights. We certainly would endorse
a fairly modest interpretation of that. And I think that, you know,
the more — I mean, there are law professors that have argued
that, you know, there's a constitutionally protected right to
use ART for reproduction. But we think ultimately that this will
not be a barrier.
The final — go ahead. The final slide simply has to do
with international considerations. These are issues that have been
already debated in the United States at an international level.
There are various, you know, approaches to that, but we basically
think that this is not the time for any consideration of international
regulation. Until you have national rules being created, it is
very, very premature to talk about any type of international agreement.
And in any case, I doubt very much that you are going to —
you are going to get it.
So that is our proposal, and we welcome — we are in the
process of working it. We solicit, you know, reactions, and we
hope to be able to actually publish the document, both the Executive
Summary and the longer version of this, sometime in the spring.
Thank you very much.
CHAIRMAN KASS: The floor is open for discussion. Jim
PROF. WILSON: Frank, you and your colleagues have done,
as I would expect, an admirable job of summarizing what needs to
be done. And as you know, I agree with you that a federal regulatory
agency is necessary, and I agree with you that research under carefully
regulated conditions on embryonic stem cells should not be barred.
My concern is with the structure of what you have suggested.
If you look at the history of federal regulation across a variety
of areas, we've had essentially two strategies. One is summarized
by the ICC, the Federal Communications Commission, the Civil Aeronautics
Board, the National Labor Relations Board, the Securities and Exchange
Commission, all created to represent interests.
And then, we have a different strategy of single-headed agencies
— the Occupational Safety and Health Administration, the Environmental
Protection Agency, the National Highway Traffic Safety Administration,
and others. And as a generalization, admitting of some exceptions
— I'll put the Food and Drug Administration aside, because
it doesn't fit any of these generalizations — the commissions
have failed, and the single-headed agencies have succeeded.
And I think the reason for that is that you can hold somebody accountable
in a single-headed agency. And if you don't like what the EPA
is doing, or OSHA is doing, you know who to investigate, and you
know who to publicize.
Secondly, we have learned from experience that when the President
makes appointments to commissions, he will appoint the obvious stakeholders.
And in the case of the ICC, he appoints railroad operators, and
occasionally truckers. In the case of the CAB, people close to
the airline industry. In the case of the FCC, people close to communications.
The National Labor Relations Board is a bit different, because
Democratic Presidents appoint union members, and Republican administrations
appoint conservative members. So the NLRB is the most frequently
sued regulatory body in the United States, because it has a built-in
degree of conflict.
So that though I am in favor of some degree of consultation, I
might not go far as the deliberative panels, because they might
exhaust this country's limited capacity for consultation. I
wonder if you have good reasons for having rejected a single agency
head in favor of a commission?
DR. FUKUYAMA: No, I'm glad you brought that up. No,
we are really not — that's not fixed in stone. And, in
fact, when we presented it to our study group, Ernie Gellhorn, who
is a fairly prominent expert, legal expert, in public administration
regulation, actually made exactly that point: that the single-headed
agencies are usually much more — I mean, apart from the —
you know, apart from the politics of the appointments of independent
commissions. He also pointed out that they are much more effective,
because you don't have to get a board of regulators to all agree
on something, and get deadlocks, and so forth.
We had started out with this idea of a — you know, of an
independent commission, you know, simply because that was the British
model. They've got 17 commissioners. But I think that that's
a kind of — you know, that's the sort of useful comment
that I think in the specifics of the design we are looking for,
because there does seem to be a, you know, strong opinion that a
single-headed agency is a — you know, is a better way to go.
CHAIRMAN KASS: Before I simply let people get in the queue
to make comment, let me make an observation that might guide the
discussion. This group — it is well-known to everybody —
is divided on the question which Frank, for his own proposal, stipulated.
Namely, judgment on the moral status of the embryos, such that certain
kinds of research would be licit, if regulated — a principle
which is not universally shared here.
And when we discussed the question amongst ourselves, it was perfectly
clear that — at least as I remember Gil putting it, he would
be delighted to support a regulatory agency, provided he could choose
the principals and name the members.
And there will be people for whom this proposal is noxious because
of that particular fundamental question. And Frank has as much acknowledged
the difficulty of trying to get this proposal a public hearing in
this country by virtue of the national division on this. It may
be more polarized than the Congress as a nation, as a whole, but
who knows until one tries.
I don't want to silence anybody who wants to raise principled
objections to the entire enterprise on those grounds, and I would
cede the floor to you. But it would be, I think, useful to Frank,
and also useful to us, for the sake of reflection to — because
it seems to me it's possible to design such a thing in which
embryo research was not the central piece of this.
So it seems to me we have an opportunity to hear — here
to think about the question of how, if one wanted to try to practice
regulatory activity in this area, knowing the problems of polarization,
and knowing the problems of capture by the regulated, what are the
ways to think strategically about how to do this — I mean,
how to do this well?
Jim Wilson's first comment starts along those lines. And
I would at least like to make sure we reserve a significant portion
of this time treating — sort of stipulating with Frank his
assumptions — and then trying to think through the mechanism,
including questions of the degree of public participation, where
this should be located, and things of that sort, knowing that there
are at least a significant number of you who were lost in this proposal
by the second or third slide, whenever it was, and this proposal
may be lost to America for similar reasons.
But it seems to me that if we're really thinking about this,
that we should try to enter into the discussion in the spirit of
a proposal as offered. People are obviously free to dissent even
from that chairman's suggestion, and anybody can say what they
wish. But that, I think, might be the most — it is a new
thing for us to try this out.
DR. GÓMEZ-LOBO: Of course, I am a voice dissenting
here, but I won't repeat the arguments. What I really need
is something like education in American constitutional law, or something
like that. And the reason is this — Frank, you extol the
HFEA, and, to be very frank, I'm rather appalled by the HFEA.
I remember when we had representatives here one person was heading
the — the Authority, and I was appalled at the lack of reflection
on the moral issues. And you mentioned several times that there
were going to be ethical issues decided by this Authority.
So the first thing I would like to know is: what's the point
of giving this huge responsibility to a body that's going to
be appointed on — I'm not sure on what grounds. I mean,
representative — you know, you gave us some leads. But if
I were appointing this Authority, I wouldn't know how to appoint
it. Probably it would end up being appointed according to political
But let me go to the — perhaps the deeper issue. I'm
sure there are sensible analogies with the ICC, the FAA, etc. But
unless I'm totally wrong, none of those regulatory institutions
deals with something as basic as this. I mean, we're really
dealing with human life, with the decisions, you know, life and
death decisions pertaining to early stages of life.
Now, even if we grant this, what I'll call "intermediate
status," which I've never understood, and you're going
to have a give me a very, very detailed explanation and argument
for the status and when it ends, etc. But are we talking here about
something that traditionally has been directly in the hands of the
state, of legislation, of the courts?
I mean, traditionally, the state is the warrantor of human life,
is the institution that we, as human beings, have to protect such
basic things. And then, of course, we go to court or there's
also penal law for breaking — you know, for having these basic
goods. So I'm just not sure — why delegate such important
decisions that should be in the hands of the community as a whole
through the Congress, through the courts? Why delegate that to,
you know, 17 members?
DR. FUKUYAMA: Well, Alfonso, we'll have to have the
discussion about "intermediate moral status" offline I
think rather than in the — in this session. I would simply
say that right now, given the nature of American law in this area,
you have delegated decisionmaking in this area to the market. I
mean, that's the only constraint that exists now.
If an IVF clinic, you know, wants to fuse two embryos and produce
a child, bring it to term, that has four biological parents, there's
no legal restraint on that. There's no legal restraint on reproductive
cloning. There is no legal restraint on, let's say, taking
a man's adult stem cell, walking it back to an oocyte, you know,
having that oocyte, you know — I mean, having the man then
be the mother of a child.
There's no legal restraint on harvesting a fetal egg, producing
a child that, you know, basically has an unborn mother. I mean,
all of these things — you know, nobody is doing that right
now, but when you say, well, you know, the state ought to take a
position on this, the fact is we don't.
And so this is, you know, our attempt to say that these are extremely
important issues, and we should not leave it up to the market simply
to decide on whether this is legitimate or not. And we, in fact,
ought to create, you know, a mechanism by which the American public,
through a kind of structured, you know, set of procedures and institutions,
ought to decide whether we actually want this thing to happen.
And I guess that's the simplest answer.
CHAIRMAN KASS: Also, by the way, just — there was
a slide of some importance on part of this that I think I'm
— if I'm not remembering, Frank did say that some of the
very large issues were not to be delegated, but had to be decided
through national deliberation, such as the question of, well, what
gets called the moral status of the embryo. And that some of the
larger issues in value terms would be set nationally by legislation,
leaving the more specific narrow questions to the Commission or
to the panel, if I'm not misremembering.
DR. GÓMEZ-LOBO: A very brief followup. What you
say is very persuasive, but it seems to me that that's precisely
an argument for legislation in the area, not for the creation of
DR. FUKUYAMA: Well, obviously, the creation of this Authority
would have to follow on a decision. For example, even in the more
— the most minimalist understanding of what — what's
permitted, you know, you do embryo research on spare embryos.
Now, as I said, the poll data seems to show that there is an overwhelming
majority of Americans that — that actually favor that. But
Leon is right that our large institutions, meaning Congress, will
have to decide, you know, on the legitimacy of that, and say that
this is something that we as a country want to do before you can
even begin to contemplate building, you know, a structure like that.
The kinds of delegated decisions that our agency would take would
not be that one. It really would be smaller kinds of issues. For
example, you know, we had this principle about chimerism. But as
we, you know, saw when we briefly touched on this issue, you know,
scientists create chimeric, you know, tissues all the time. And
is that legitimate or not?
And, you know, at what point does it begin raising, you know,
some delicate, you know, ethical kinds of issues? I mean, that
— I don't know whether that's the best example of
this, but there are, you know, other kinds of complex decisions,
or the sorts of things that the HFEA has actually, you know, passed
judgment on it. Is it legitimate to create a child simply to provide
bone marrow for a sibling? You know, that kind of issue.
And I just don't think that Congress has the capability, the
time, the interest, or the inclination to pass a law saying whether
that's legal or illegal. I think that that is, you know, preeminently
a kind of decision that ought to be made by this kind of an administrative
CHAIRMAN KASS: All right. I have Gil, Mary Ann, myself,
and then Mike.
PROF. MEILAENDER: Frank, a question, just a structural
question. When you were going through the — you had several
things on the pros and cons of the alternative approaches, and the
first of the alternative approaches was to use some sort of existing
way of dealing with it.
In two of the cons, there were "inadequate public participation"
and "hard to change bureaucratic culture." But those
don't return in relation to your own proposal. And I wondered
whether they ought not return in some ways.
In terms of inadequate public participation, if I understand —
now I wasn't sure, and you were going fast I know at the end,
I wasn't sure if I understood correctly, but the one thing that
you're adding is the consultative college, which almost sounded
like an internet undertaking?
DR. FUKUYAMA: Well, that part of it would be that.
PROF. MEILAENDER: Okay. I mean, if that's it —
DR. FUKUYAMA: No. And the deliberative panels —
I mean, a large number of deliberative panels, which are basically,
you know, structured town hall meetings where you'd have to
give a lot of thought to, you know, balance in terms of representation
and who's invited. Aand they would be deliberative, you know,
empanel people to discuss these issues for, you know, a couple of
days to —
PROF. MEILAENDER: Didn't you say that some of that
already occurs in other contexts?
DR. FUKUYAMA: Yes. I mean, you'll have some agencies
that will empanel one group to do this.
PROF. MEILAENDER: Okay. And you're just going to
do more of it, is what you're saying?
DR. FUKUYAMA: We're going to do much more of it, yes,
to make it much more representative —
PROF. MEILAENDER: Okay.
DR. FUKUYAMA: — and —
PROF. MEILAENDER: Okay. Well, I mean, at any rate it
seems to me there are some questions to raise there. And then,
granted, there wouldn't be a bureaucratic culture in place,
because you're creating something new. But wouldn't it
very quickly develop a bureaucratic culture? And a bureaucratic
culture precisely about some —
DR. FUKUYAMA: Oh, sure.
PROF. MEILAENDER: — some issues that perhaps need
to return regularly to public discussion rather than be bureaucratized?
DR. FUKUYAMA: All organizations have bureaucratic cultures.
I mean, it's simply the — I think the nature of, you know,
human behavior that there are informal rules that guide the way
that, you know, people cooperate and make decisions. And what you
want to do is not to avoid having a bureaucratic culture, you want
to have the right bureaucratic culture.
And I think the problem comes up, you know, particularly when
you talk about giving the FDA power to, you know, regulate things
that have an ethical component, that has never been part of what
they understood themselves to be doing.
And I think the experience is that if you've gotten, you know,
a group of regulators that really saw themselves as professionals,
that kind of stood apart from these kinds of ethical considerations,
it is really, really difficult to — you know, to get them
to change. And so what you would want to do presumably is create
an institution where the bureaucratic culture supported ethical
argument of the sort that we've had in this — you know,
in this Council. And that would be part of the tradition of, you
know, civil deliberation where you take seriously, you know, the
kinds of concerns that, you know, fall outside of the mandate of
the existing regulators.
PROF. MEILAENDER: But a whole range of positions might
not find their way into that deliberation, right? I mean, there
wouldn't be any reason to put some people on this regulatory
agency if they simply thought that some of the things shouldn't
be done that you were proposing to —
DR. FUKUYAMA: Well, yes. Again, you know, the composition
of the agency would have to — I mean, our view is it should
— is the goal should be that it should be as broadly representative
of, you know, American — the American public's views of
this as possible. And as I said, that does not amount to the views
of the existing well-organized interest groups, because we believe
that those interest groups are way too polarized and are actually
We actually think that there's a group, you know, much larger
group in the center that would be broadly supportive of this, and
that's what we want to try to get at through these institutional
mechanisms. So I don't think it's that — you know,
quite that whimsical. I mean, we really are trying to make this,
you know, both representative and deliberative.
CHAIRMAN KASS: Mary Ann.
PROF. GLENDON: Alfonso's question I think reminds
us of some conversations we had a while back about what other countries
do. I noticed that Frank refers to the Canadian and English systems,
but deliberately bracketed the continental.
But if you recall, in a previous meeting, we saw that all of these
matters are heavily, strictly regulated in the Romano-Germanic systems.
And so I think that — in my own experience, when I talk about
these matters with Americans, they are surprised, as Alfonso was,
that there is no regulation of that whole list of items that Frank
just reeled off.
So I'm wondering, Frank, whether part of your project —
I guess I'm hoping that part of your project, even in the deliberative
stage, would be to try to use your deliberations to raise the public
profile of the issue. I mean, to this day, to this very day, we
have people in the United States who think that Roe v. Wade only
regulates the first trimester of the abortion — of pregnancy.
So this misunderstanding has been deliberately fostered by groups
that have an interest in fostering that misunderstanding. But it
seems to me the same is true here, that as long as the — the
actual state of affairs is not well-known, there are a lot of —
of mice about playing.
So I wonder if you're thinking about, even at this stage,
not just having closed meetings, or relatively closed meetings,
but this is the kind of thing you could get on television with,
you could — I mean, op-eds, I don't know how many people
they reach, but I really think this is a hot subject. And that shock
response that Alfonso had is a response that you would find in a
more general public and that you would — there would be a
way of educating the public to get better quality responses to the
polls, and, in turn, get better ideas about the question that you
and Jim were talking about.
There are many tools in the legislator's tool box. And at
this point, I think it's very difficult to say which is the
right one, or what combination. That's a very difficult technical
question that is different for different areas. But I think you
might — if the public discussions should — could somehow
be stimulated, you might get some guidance on the technical regulatory
DR. FUKUYAMA: Yes, if I could just say I think you're
right, and one of the central purposes of our project was just to
get this R word out into the public discussion, because, as I said,
you know, I think actually if — John Evans wrote a very interesting
book about the history of the bioethics — the whole bioethics
But I think in some sense the reasons that you have bioethics
advisory councils and commissions, and so forth, was a deliberate
decision by the scientific research community and by the biomedical
industry back in the 1970s to actually stave off formal regulation
by, you know, in some sense inviting this self-regulatory model,
together with, you know, essentially toothless advisory commissions.
And while I much enjoy sitting on this panel and hearing the discussions,
I just think that that's not an adequate, you know — but
there's been — but that strategy has been actually very
effective, because any time someone has raised the question of regulation
people say — you know, react as if they've seen, you know,
the devil or Satan himself, and,you know, how can we talk about
this? Whereas, in fact, you're absolutely right that virtually
every other developed country has, you know, addressed this much
more seriously than we have.
And so part of I think our purpose — and I'm glad that
we have this opportunity to, you know, get this out, to simply put
this in front of people and say, "Maybe you don't like
our particular, you know, version of it, but I think we got —
this is the real issue that I think we've got to address."
And not — and, you know, the more philosophical discussions
I think are extremely important and rich.
But as a matter of public policy, I think this is where we've
got to — you know, we've got to turn at this point.
CHAIRMAN KASS: I am next, and then I have Mike, Peter,
One of the things that I like about the proposal, and in a way
the idea behind the proposal, is precisely the beyond bioethics
notion. And the recognition that these questions are not questions
that should be solved by some marriage between scientific/technical
expertise presenting the shape of the problem, and so-called ethical
expertise resolving it.
Anecdotally, there was a meeting at the National Academy of Sciences'
Panel on Stem Cell Research, and I gave a presentation there in
my own name. And there was a dinner the night before, and one of
the scientists there said, "Look," he said, "you
fellows really could solve all of your problems on this Council."
I said, "Oh, really?"
He said, "Yes," he said, "you should just change
the membership." And I said, "Yes." And he said,
"Yes. What you have to do is appoint ethicists, appoint bioethicists."
And what he really meant was the bioethicists that sit on the committee
of the hospital where he is, where there really are no fundamental
disagreements, and it took me half an hour to explain to him, look,
the reason we have differences of opinion here is that there are
real issues on which people are — are deeply divided and that
are not somehow resolved by appealing to expertise.
And Gil, in a very nice little piece, responded to complaints
against this Council that we had somehow politicized science or
politicized bioethics, and he turned that accusation into a kind
of praise, if by politicization it meant away from government by
experts in these matters and a return of these questions to the
polity as a whole.
So I applaud that, and I applaud whatever measures would be built
into this to enlarge the public consultation, the public participation.
These are questions that really affect the well-being of all of
us, though as we learned this morning one shouldn't exaggerate
the ability of the public simply to understand or simply to decide
with projections about the future. I mean, there's —
one should be very modest about this.
My difficulty comes with the question of what the conception of
— not what the moral principles are, but what the view of
moral judgment — the kind of moral judgment that such a body,
since the final judgments will be left with these commissioners
or with the commissioner as you will.
Sometimes, not in your account, but sometimes people say this
really is a test for rule of the wise, not the experts mind you,
but for people who are, you know, somehow the repository of the
greatest wisdom that we can have about these matters. And that
should be the criteria for appointment.
There are people in this room who think that conditions of appointment
should be governed by those capable of sound moral reasoning. There
are other people — in fact, the President when he met with
us, I don't think I'm telling tales out of school —
exhorted this body — we can debate whether we've been
this or not — not to be sound moral reasoners, and not to
be philosophers, but to be the nation's conscience in these
None of those things do I hear from your proposal. What I hear
is something like a high-class National Opinion Research Center,
which tries to take the temperature of the public and not function
as the Burkean representatives of the public as we heard this morning,
but, in fact, to find out where the public now is on these questions
and take it there.
And maybe that's right, and maybe that's what it means
turning these matters over to politics. And it means perhaps finessing
questions of inflexible moral principle and allowing this utilitarian
country to, you know, find its most comfortable bottom.
But I guess I'd have to say that I'm slightly disquieted
with such sort of large matters on the table to say that what you
really want here is a group of people whose main virtue is they
learn how to take the public temperature and blow with the wind.
Now, you haven't said that, but it seems to me what —
what is there in the conception of this? How does somehow taking
— taking the opinion polls, or having these — you know,
letting the guys who have access to the internet exercise their
undue influence on this process, and actually trying to govern wisely
in these matters, granting that we don't have philosopher-kings
to rule, nor necessarily should we?
DR. FUKUYAMA: Well, that's a very good question.
In a sense, that's why we had that two-tiered structure, because,
you know, Jim's observations about the problems of commissions,
you know, being well taken. You know, the idea was that you'd
have a — actually, a smaller deliberative body that was composed
not simply of the appointed stakeholders but, you know, of genuinely
independent people that were capable of some degree of this kind
of, you know, moral reasoning, and that would be selected for their
ability to do that, that would actually have the real — that
would have the real power to — you know, to make the decisions.
And all of these new — all of the new public participation
mechanisms were not the point of that — you know, that smaller
group was not simply to take the pulse of the public. But it was
to take their input but use their own judgment — you know,
combine that with their own judgment to — you know, to deliberate
and to come to judgment.
So there really is a kind of two-tier — so there isn't
a mechanical sense in which, you know, there are people with real
statutory power simply trying to do this sophisticated polling.
But it's something I think a little bit more balanced between
— because I think that the other model where you simply delegate
it to these wise men or women has also got a lot of problems, because,
you know, they can get quite out of line with what is often the
common sense, the common moral sense of, you know, the broader public.
CHAIRMAN KASS: Good. Jim, do you want to add something
to this point? Please.
PROF. WILSON: Yes. I don't really follow your point,
Leon, because I may have underestimated the significance that Frank
attached to these deliberative panels and the consultative college,
and I hope I underestimated because I really think that's not
the best part of his proposal.
I think the best part of his proposal is to go to Congress with
whatever political argument will get him there. As Mary Ann said,
the average public person needs to be told that we are the only
country in the world that doesn't regulate any of these things
and get Congress to pass a law.
Now, Congress may well pass a law that says we're going to
create this agency, and we're not going to allow research cloning.
But it will regulate all of these other things. I don't know
how the debate will come out, but that's one very likely outcome.
To me, that would be okay, because we would then begin to oversee
Now, the other things that would be overseen would not be established
by some government-sanctioned National Opinion Research Center.
These will be all things that Congress would decide. Congress is
very ginned up about this question. They would start passing rules
about chimera and hybrids and sex selection, and all of the other
things that the ART clinics now think they self-regulate, but, in
So by the time the law was finished, and I would imagine it would
be conservatively 50 single-spaced pages long, the Congress would
have told the agency what to do. And what the agency would wind
up doing is administering those laws.
Now, I personally would hope they would allow research cloning,
but I'm not optimistic. But even if I'm wrong on that,
it seems to me the debate will not be between Congress passing a
general law that says, "Seek the public interest and implement
it," and leaving to the agency the job of defining it. Congress
will define, as best as it could, all of these matters, and the
agency I imagine will have relatively little discretion.
CHAIRMAN KASS: Mike Gazzaniga, then Peter, then Paul.
DR. GAZZANIGA: Yes. So let's roll the clock back
here a little bit and be concrete. It was almost two years ago
— two years ago that we had our little 10 to 7 vote, where
7 of us were against cloning of all types, 7 of us were for going
ahead with biomedical cloning, with regulations, and we didn't
specify what that meant.
And three — and two of them are here — Frank and Paul
— were for — didn't have an ethical problem —
but wanted a moratorium until regulations were in place. Is this
what you meant by "regulations in place"? So the question
I have is: is this the kind of thing that Paul meant? Is this
the kind of thing you meant?
And we can find out from Frank is — which all of a sudden
means that we have 10 members who are for biomedical cloning, and
not this, with the proper regulations in place. Because I didn't,
at the time, really understand what we meant by that, because I
spend half my life trying to get around regulations. So I —
I have an allergic reaction to the regulations.
CHAIRMAN KASS: What did you do with the other half?
DR. FUKUYAMA: Just on that one — you know, I didn't
write a personal statement at the time that we took that vote, so
I didn't explain my position. But, you know, my position was
that I was in favor of a moratorium, because I did not think it
was safe to proceed with this until you had a regulatory structure
in place, and I thought it would take at least four years to —
you know, to produce that.
Now, that doesn't mean I'm in favor of doing it now, because
this regulatory structure is just a proposal. I mean, I think you
really do need to make some progress in having in place an institution
that will actually provide some real safeguards, not the Proposition
71 kinds of things, but some real safeguards.
And if we are into that process, and I'm convinced that, you
know, that's reality, then in fact I will change my vote and,
you know, vote with you. But I'm not ready to do that now,
because I don't think we're at that point.
PROF. GEORGE: I think it's also true, isn't it,
that Rebecca's argument was not an argument that had to do with
putting a regulatory structure in place. She's got a personal
statement on it, and I don't think that the answer Frank just
gave corresponds to what she said.
CHAIRMAN KASS: Peter Lawler, and then Paul McHugh. And
we are getting close to break time, so if people want to add —
DR. LAWLER: Yes. I think I would be most for this in
the way Jim Wilson just laid out. As Congress would legislate extensively,
and the point of the regulatory agency would be to administer the
laws Congress had passed, because this is — it's an odd
thing about America that on this issue the left is libertarian.
You would think that the left, as the body that — the climate
of opinion that wants to regulate the excesses of capitalism, would
want to regulate here big time because capitalism has so many excesses.
So in order for this to be possible, I think a bill that narrowly
passed Congress because of a Republican majority and Democrats from
red states voting for it out of necessity, wouldn't give us
what we need. The left has to be converted in some respects. Mainstream
Democrats have to be converted in some respects to the idea that
regulation in this area is appropriate.
And it's strange that our country has been transformed, that
on these crucial cultural, social, life issues, the Democratic Party
is the libertarian party now, because to listen to the Democratic
Party you get this opinion: You have sensible people, and you have
religious nuts. And the sensible people are for no regulation at
all, even though — so the sensible people are not to be told
what goes on in Europe, and even in Canada and Britain, and so forth.
So the first step here is for someone — Frank and his friends
— to — to enhance public awareness of this. This, more
than other areas of capitalism, demands regulation because of the
great possibilities for the destruction of life and for tyranny
in this area.
CHAIRMAN KASS: Do you want to hold off, Frank, and we'll
get Paul McHugh's comment, and I think that's where we are.
So we'll —
DR. McHUGH: Yes, I have a comment and a question. First,
the comment is that, yes, Mike, this is what I was looking for.
I'm looking for the building up of a regulatory system —
a regulatory system that is responsive to the American people through
the Congress, and should lay out right off the bat what we're
doing and start putting some sense into this free market system
that has all kinds of abuses to it.
And you know that, though, as well I believe there is a difference
between in vitro fertilization and the use of those embryos and
somatic cell nuclear transfer and those things. I won't, once
again, raise the clonote, but it lives.
Now, I have one question, and that is: why do you start off by
saying that embryos have — the whole idea about this is intermediate
status for the embryo? You just get people's dukes up. Why
don't we just get started and saying on the regulatory business,
"We need a regulatory agency. We have Jim's genius and
your genius to start putting these things together and make it happen."
What do you want to get people's dukes up for? So that's
And then, it's just a question of fact, and that is this issue
of polling, and views that the American people have, which have
been so often wrong. On page 10 of your things, you confused me
when you said that the interest groups demonstrate that the public
attitudes towards research cloning are that fundamentally people
oppose it two to one. And then you come down here and say what
human embryonic stem cells, though, are — polls show that
they are for embryonic stem cells.
But the question is being asked there of them, from which you
have developed that idea, is "should excess embryos be used
in medical research?" And the operative word there is "excess."
And if in the process of asking that question you — you told
people, "by the way, we're going to produce these excess
embryos every time we have an in vitro fertilization experiment,
because we're going to make 8, 10, 12 of them, and they're
going to be around, and we're going to continue to make these
people— do you really want to make these embryos? " What
would the American public say? I believe the American public would
say, as the German people say, no IVF unless you're going to
implant them. And why not?
DR. FURGER: If I may, I mean, it's in part a matter
of how these questions have been phrased. But generally speaking,
the surveys have tended to distinguish between a possible use for
research purposes of excess donated embryos as a self-contained
question on the one hand, and the possibilities of — the possibility
of conducting research cloning as a separate issue.
Now, obviously you can combine these two things. But if you ask
this question in a separate manner, you realize that when cloning
is implied, there is much more ambivalence about the procedure,
whereas a semi-pragmatic approach, the use of excess embryos for
research purposes, you know, it's a lot less —
DR. FUKUYAMA: Existing ones that are already in —
you know, being stored, cryogenically stored.
DR. McHUGH: I mean, that's something that we ought
to be talking about broadly in the public. And building up a regulatory
agency and hearing from the Congress as to whether they think the
excesses are going to continue to become excess — because
whether we're going to continue the process of in vitro fertilization
or not becomes a matter for regulation.
But, anyway, I just think the way you ask that question to anybody
in the — in the population, you ask them — "Well,
they're going to die anyway, so there you — let's
do something with them." Everybody gets up and says yes.
But if you say tomorrow, "Well, look, we're going to
start producing these so-called excess embryos because, after all,
they're accessible to us, and we ought to build them. And when
we do them, we're going to implant some, and we're going
to chop the others." Then, I think the American people will
probably rise up, like they say about research cloning here and
say, "Not on your life."
But that's to bring us back to what Alfonso — what you
said you didn't want to develop here. Answer me this question:
why do you want to start this off by saying something which raises
a red flag about the intermediate status of the embryo? Just tell
DR. FUKUYAMA: Well, that's — it's very simple,
because I don't think you can sneak it by people.
DR. McHUGH: Oh, I see.
DR. FUKUYAMA: I mean, this is a proposal to create a regulatory
agency that would legitimate stem cell research. There is just
no — and it will involve embryo destruction. The most limited
form of that is — is using, you know, preserved embryos in
existing, you know, embryos in IVF clinics.
But if you believe that that is illegitimate, period, then you're
not going to like this proposal. And I just didn't think that
it would — you know, I mean, so I just thought it's better
to be up front about the fact that —
PROF. WILSON: Well, Frank, there's another strategy.
The other strategy is to make the list of all of the things that
ARTs don't like and don't approve of, but are done anyway,
and make those the subject of federal legislation.
I mean, the only way you're going to get Congress to pay any
attention to this bill is to call attention to widely-admitted abuses,
regulate them, and then cross the next step, if you can cross it,
which is to say, well, we've got a regulatory agency, it's
working reasonably well, shouldn't we be allowed now to use
excess embryos from IVFs? You don't want to start with the
IVFs. That is a political loser. Start with the abuses.
I mean, I don't know why we're sitting around having a
talk about practical politics in Washington, D.C. It seems so inappropriate.
I'll shut up.
CHAIRMAN KASS: That's why we bring people from California
who know something about it.
Let me make one — just one — I lost it. It wasn't
Let me just thank Franco and Frank for bringing this — this
proposal back before us for discussion. We'll adjourn until
Those of us meeting for dinner, Primi Piatti is at 2013 I Street,
one street to the north and about five streets to the west. And
you're better off walking on I Street than on H, where there's
construction. Tomorrow morning we start at 8:30.
Oh, I remember what it was. On this business about the stem cells,
tomorrow morning we're actually going to hear some interesting
things on this subject, which might provide a way forward that doesn't
require one to lead with one's chin, and nevertheless provide
some suggestions that if all goes well might command some interesting
assent around here.
So let's look forward to that presentation tomorrow, as well
as the presentation from our Canadian colleagues. Let's be
on time for them at 8:30 tomorrow.
The meeting is adjourned.
(Whereupon, at 5:32 p.m., the proceedings in the
forgoing matter were adjourned, to reconvene at 8:30 a.m., the following