"This transcript has not been edited or corrected, but rather appears as received from the commercial transcribing service. Accordingly, the President's Council on Bioethics makes no representation as to its accuracy."
THIRD MEETING
Friday, April 26, 2002
Session 6: Regulation 1:
Regulatory Approached to New Biotechnologies
CHAIRMAN KASS: All right. We convene for the
second-to-the-last session. We will have a session for public comment
beginning shortly after noon, after 12:00, but this session is an exploratory
conversation on the subject of regulation of biomedical technologies.
And it's a subject that Frank Fukuyama has especially been interested
in.
Since I mentioned it in the first meeting and Frank prepared the -- a
short memo at our request, Frank, do you want to say something further
about it to get started? We've had a couple other people prepare to lead
off in response, but would you like to just hit a couple of high points?
PROF. FUKUYAMA: Sure.
CHAIRMAN KASS: And then, we'll take it from
there.
PROF. FUKUYAMA: Yes. Well, I -- you know, I
must say I begin this not as any fan of regulation, but I do think it's
worthwhile considering whether we need to think about a new set of institutions
to regulate biotechnology.
Now there are a couple of I guess precedents for this. One is, you know,
something like the Interstate Commerce Commission that Jim Wilson mentioned.
Actually, I appreciate this idea that you shouldn't create institutions
in the absence of real problems. I actually think that we have real problems
that such an institution would address.
But it seems to me that a lot of Jim's examples actually -- I'm not sure
which direction they point to, because they were all cases in which you
had established regulatory agencies that had to deal with a new technology
and try to incorporate, you know, that into a preexisting regulatory structure.
So trucks into a system that had been designed to regulate railroads or,
you know, satellite television into a system that had been designed to
regulate, you know, land-based telephones. And the question is whether
we aren't at such a juncture.
And, in fact, if you look at the FAA -- you know, when airplanes came
along, people decided that this was a sufficiently different technology
that they didn't give it to the Interstate Commerce Commission, which
was an option, you know, that was available at the time.
And so now in agricultural biotechnology, the Reagan administration actually
had a series of meetings in the 1980s to decide whether the new, you know,
recombinant DNA technology was sufficiently different that it required
a new regulatory structure. And the result of that, they decided they
were going to regulate on the basis of product, not process.
It wasn't sufficiently different, and I think that was a -- you know,
a perfectly defensible decision on their part. And so right now agricultural
biotechnology is regulated by the Agriculture Department, the FDA, and
the EPA.
I think that there are a number of reasons that I outlined in the memo
for thinking that, you know, we're going to face a lot of problems that
Congress should not have to intervene on. I mean, there are just going
to be too many decisions that will have to be made for Congress to intervene
the way it is intervening on the question of human cloning, which means
some delegation of decision-making authority to another agency.
Besides the ones I listed in the memo, if you just think about the issues
we talked about yesterday having to do with stem cells and the treatment
of embryos, you know, one clear approach to -- that would satisfy, for
example, a lot of the concerns I have about cloning and embryos would
be to establish a clear-cut regulatory structure for experimentation on
embryos.
So that, for example, the line of questioning that Bill started, you know,
that right now we want to do things to embryos that aren't older than
14 days, but supposing down the road someone will decide that you actually
need to do something to fetuses, you know, one way of solving that --
I mean, if your real worry in the short term is that slippery slope, then
clearly one solution to that is to set up a regulatory structure that
would cut things off at 14 days and say, no, you cannot -- you know, we're
going to permit cloning or stem cell research up to this point but not
further, and put a break on that particular slope.
And there's actually a model out there, which is this Human Fertilization
and Embryology Agency, in Britain that does that, that regulates embryo
research. It regulates their IVF industry and establishes these kinds
of rules for, you know, that sort of experimentation. And they've already
done it. In fact, it's a 10-year old agency.
And I think that, you know, I personally do not have any concrete ideas
about, you know, what the institutional design for such an agency or --
you know, first of all, I'm not wedded to the fact that we need a new
agency. I think simply that we need to think about it, but -- and I'm
not wedded, certainly, to any particular institutional design.
But I do think that it is an issue that we need to look at very concretely,
because there really are holes in the current structure. I mean, the one
-- the biggest hole really has to do with the whole, you know, private
sector and the whole private, you know, biotech industry, which does not
fall under the NIH's rulemaking power, which, incidentally, the British
law, you know, fixes.
There is no such distinction between public and private in the British
regulatory system. And that's a problem that comes up with -- you know,
with an agency like the RAC, the Recombinant DNA Advisory Committee.
Janet and I were talking about this over breakfast. I think that that
was an exemplary, you know, instance of self-regulation by scientists,
and it worked -- you know, is a system that worked, you know, quite well
in its inception.
My understanding is that a lot of people that work with it now think that
the industry and the -- you know, the structure of scientific research
in the United States at this point has outgrown that particular structure,
because there is so much that's now done, you know, in the private sector.
Now, I don't necessarily believe that -- I'm not trying to argue that
we need more formal regulation or that self-regulation is impossible.
I just think that, you know, it's a serious set of issues that -- you
know, that deserve to be looked at.
So let's -- all right. Let me just stop there.
CHAIRMAN KASS: Thank you very much.
I have asked Rebecca Dresser to open up response with -- after Frank's
introduction. Please.
PROF. DRESSER: First, I'd like to commend Frank
for his cogent and articulate case in favor of a more systematic approach
to regulating biotechnology. In calling for added oversight, he really
joins a number of other scholars and advisory groups addressing bioethics
issues.
For example, in 1995, Dr. Jay Katz, a respected medical ethicist, called
on the government to create a national board authorized to regulate all
research involving human subjects, including funded by the private sector.
The board, in his proposal, would consider big picture questions that
are too broad and complex for institutional review boards to evaluate.
Others have made similar proposals contending that a national board is
needed to review proposals for research that could affect the human germ
line, research on xenografts, research on certain assisted reproduction
methods, and experimental attempts to create human-animal hybrids.
Fukuyama writes -- and this is a quote -- "Deciding where precisely
we should draw lines concerning technologies that have not yet come into
being is not a fruitful exercise at this point. It's less important at
this point to make up a definitive list of restrictions than to think
about general principles that should govern the development and use of
biotechnology and to begin designing institutions that will enable us
to make critical decisions in the future."
I agree with this, but I do want to emphasize the challenges that are
in here and the effort to settle on even general principles and institutional
design.
Difficulties in carrying out these tasks are a major reason why the earlier
proposals I mentioned have failed to produce national oversight systems.
Let me give you a couple of examples. In the 1970s, Department of Health,
Education, and Welfare created an Ethics Advisory Board to determine whether
the Federal Government should fund research on in vitro fertilization
and early human development.
The Board was given the responsibility to review each proposal seeking
government funds. So it reviewed the topic and made general recommendations
about the criteria that should govern federal funding. But then, its charter
lapsed in 1980, and it wasn't renewed. And then throughout different administrations
the Department of Health and Human Services Secretaries, nobody would
pick this up off the desk and would appoint another Ethics Advisory Board.
So most people looking at this attributed the inaction to politics, controversy
surrounding the status of developing human life, produced a reluctance
to adopt explicit government policy on IVF research. As a result, the
Federal Government failed to engage in oversight of research related to
assisted reproduction, and this is what led to our current situation in
which such research is supported by private funds, subject only to voluntary
guidelines prepared by professional organizations and by the researcher's
personal ethical beliefs.
A more recent example of the difficulties in establishing even general
principles and oversight mechanisms concerns research involving people
with dementia and other mental disorders that may affect decision-making
capacity.
Many people think that current U.S. regulations are inadequate to resolve
the ethical issues that may arise in research involving this population.
In 1998, our predecessor, the National Bioethics Advisory Commission,
produced an extensive report and recommendations including recommendations
that the Secretary of DHHS appoint a national special standing panel to
review certain ethically controversial proposals and supply guidance to
IRBs reviewing studies involving this population.
After that, though, some psychiatric researchers spoke out against this
recommendation, claiming that it would impede the search for treatments
to help people with mental illnesses.
And because of disagreement, then, about substantive principles, such
as the degree of risk that's acceptable in research involving people who
have impaired decision-making capacity, and disagreement about the structure
of oversight, whether it should be national or whether local IRBs were
sufficient, because of these disagreements the DHHS has not created this
special standing panel.
So I think we cannot underestimate the barriers to moving forward. So
then, how do we begin the task of developing general principles and designing
institutions that would apply them?
Well, first, I do think existing institutions could apply existing principles
in ways that would address some of the moral issues that biotechnology
raises.
As pointed out in our cloning discussions, current U.S. regulations say
that risks to human research participants must be reasonable in relation
to expected benefits, either to participants if there are any, or to the
importance of the knowledge that the study will produce.
So the regulations incorporate this idea of justified risk to subjects.
And I think this requirement to determine whether a study will generate
information that is important enough to justify exposing study participants
to risks offers an opportunity for IRBs to evaluate whether, for example,
an experimental intervention that could increase a child's height offers
a significant enough benefit to justify exposing children to physical,
emotional, and social burdens in the study process.
This offers a mechanism for determining whether the potential benefits
available through experimental interventions on what many of us would
view as enhancements warrant exposing children to the risks present in
the testing process.
FDA regulations that exist now also offer related opportunities. The FDA
does require all private research sponsors seeking to test drugs, devices,
and biologics to have their studies reviewed by IRBs before there is any
human exposure. And the regulations direct IRBs to evaluate, again, whether
the risks presented in -- by an investigative drug or device are reasonable
in relation to potential benefits.
FDA officials deciding whether a product is safe and effective enough
to release into the market can also take into account relative harms and
benefits. Former Commissioner David Kessler did just this in 1992 when
he said that silicone breast implants would be available only to women
who had had mastectomies. He decided that the benefits of the implants
used for cosmetic purposes failed to justify exposing women to risks of
this device. That is, the risks of the implants were unreasonable in relation
to the cosmetic benefits.
In his judgment, implants for enhancement purposes were too risky, and,
thus, unsafe. But the risks were acceptable if the implants were part
of treating a disease.
Now, in defending the ruling he wrote, "Certainly, as a society we
are far from according cosmetic interventions the same importance as a
matter of public health that we accord to cancer treatments." So
whether or not one agrees with this particular judgment, I think the case
does show that existing FDA standards permit the agency to make decisions
based on comparative harms and benefits available through biotechnology
interventions.
Nevertheless, I do agree that broader standards than currently exist are
needed to respond adequately to these innovations, and also that the current
oversight institutions are inadequate to produce such a response.
Indeed, the current U.S. regulations explicitly direct IRBs not to consider
as research risks, "possible long-range effects of applying knowledge
gained in the research -- for example, the possible effects of the research
on public policy." Yet this is exactly the sort of effect that Fukuyama
and many other people are worried about.
Now, of course, assessing the moral and social implications of biotechnology
innovations presents daunting questions. In most cases, review groups
have to evaluate potential harms and benefits to future generations, and
these are effects that are highly uncertain and depend on many other variables
besides technology development. I've heard them described as radically
contingent.
And so settling on general principles won't be easy. For example, in Frank's
materials he mentioned the precautionary principle that they use in Europe
to assess new agricultural biotech innovations. Should we have a similar
principle with human biotech innovations that requires some sort of demonstration
that these innovations are "safe for society"? And then, what
does "safe for society" mean?
How do we determine when a technology presents too great a threat to shared
humanity? And these are terms that Frank mentioned in his materials as
sort of general standards.
And then, also designing a review process is difficult. If we're going
to assign these decisions to review groups, what should the composition
be of the group? Which professions should be represented? And other kinds
of experts.
If we are to include public representatives -- and I do think we should
-- we would want to find people who are not intimidated by the experts
and who can inject an independent voice. This has been a problem with
IRBs who are supposed to include people like this, but it can be very
difficult to find them.
We also need to recognize the cost of a good review system. I think as
we are learning from our council experience, it's really tough to do justice
to these kinds of activities and still keep your day job. So, again, this
is one of the major problems with IRBs. Everybody has their "regular
job" and is scrambling to devote enough time to this review responsibility.
So we have to think about where the resources will come from. An underfunded
oversight system that looks great on paper won't have its desired effect
if there's not enough money to pay for it.
And, finally, apart from this call to regulate, Frank argues for certain
substantive restrictions on cloning and other biotechnology developments.
At the same time, he recognizes that in the contemporary United States
there are strong social pressures that favor scientific freedom, economic
opportunity, reproductive choice, and improvements in health as well as
quality of life.
In our democratic system, groups representing these interests will undoubtedly
participate in designing the oversight system and, thus, the standards
and structures are likely to take these interests into account.
My own view is that encouraging a thoughtful approach to regulation will
require much better communication with the public about the technologies
at issue. I think a major problem today is the failure of the media, industry,
and scientific organizations to acknowledge how uncertain are the potential
benefits of this technology, and also to place these developments in the
context of a nation and a world that are struggling to meet basic health
care needs of many people.
So, in sum, Frank's account has two elements. One is on the need for regulatory
institutions, and one is on what he believes should be the desirable content
of that regulation. It might not be difficult to reach agreement on the
first element, but I think that substantial barriers to agreement on the
second exist. And this is why I think a lot of times the institutions
don't get created, because people can't agree on what even the general
principles would be.
Despite all this, I do think the Council should take up Frank's charge
and consider next steps. That is, what general principles should govern
biotechnology research and use? And what would be the characteristics
of an adequate regulatory system?
In one sense, I think our Council is a good test case. We're very diverse
in our disciplines and our values, and, thus, if we can begin to answer
these questions, perhaps other groups, our elected representatives, and
other government officials can do so, too.
Thanks.
CHAIRMAN KASS: Rebecca, thank you very much.
Let me recognize Mary Ann and then Jim Wilson.
PROF. GLENDON: Well, I, too, am very grateful
to Frank for opening up these questions of regulation and institutions,
and to him for recognizing the political dimensions of the problems that
we are going to be addressing. And so I would add my voice to those who
encourage the Council to explore these matters further.
I think that the political discussion of regulation and institutions has
to begin a step earlier with the question of priorities. I think my remarks
in the last session might have been misunderstood by some of those who
commented on the topic.
When I raised the question of allocation of scarce resources, I was not
trying to make a point about equality, but, rather a point about priorities.
And I think the beginning of wisdom in this area has got to be an investigation
first of, what priorities has our society established already in the area
of biomedical research and biomedical technology, either intentionally
or by default? Where are we going? And then, is that really where we want
to go? How are those priorities established? is a political question.
I would also suggest that as we explore those kinds of issues that we
take account of the effects of a major demographic change on the politics
of this whole question. I referred earlier to the aging of the baby boom,
and I referred to it in the context of increasing demand for certain kinds
of services that have a moral dimension.
But it has another effect. And if you look a little bit further down the
line, the aging of the baby boom is causing a change in the ratio of active
workers in the labor force to persons in the population who are dependent,
retired and frail, elderly, very young, etcetera. That second change may
very well have some very sinister implications, not only for enhancement
but for other desires of the aging baby boom population.
CHAIRMAN KASS: Thank you.
Jim Wilson?
DR. WILSON: I will join in the praise for
Frank, and I was especially impressed with Rebecca's very careful analysis
of this. There are only a few points I can add.
My discontent with the conversation we had over the last hour -- a discontent
I am unable to mask because I lack sufficient control of my facial muscles
--
(Laughter.)
-- reflects the fact that we were not focusing on something concrete.
It's not the job of this body to make rules about Ritalin or, to use an
example I threw in, hand-held calculations. We're really concerned with
the possibility of germ line strategies, and we must be very specific
in our future deliberations in enumerating those things which are: a)
sufficiently important, and b) sufficiently likely, so that we know what
we may have to regulate.
And should the Council endorse cloning for biomedical research, we have
to be clear about what regulatory mechanisms would be employed there.
Although I think the Council will be divided on this issue, we should
not pretend that the problem does not exist. So I think my first piece
of advice is to the staff, let's be as focused as we can the next time
we visit this question, so we can talk about these things in rather concrete
detail.
Secondly, when we design or think about designing regulatory bodies, we
must consult with the bodies to be regulated. That is to say, the membership
of this Council need not be altered, but we must enter into some degree
of informal consultation with people in biotechnology and others who are
active in the field in order to understand what is happening.
One of the lessons I have learned after studying political science for
40 years is that the threat to the republic rises -- is much greater when
it arises from ignorance than from influence.
Our constitutional system and the courts that oversee it are well designed
I think, by and large, to handle the excessive use of influence. But they're
not at all skilled at handling ignorance, and we have to figure out how
best to design something that will work in the practical world.
David Kessler's quote that Rebecca Dresser gave was to me an example of
ignorance. In the view of many people for whom I have the greatest respect,
it was, in fact, an example of duplicity when he made certain assumptions
about silicon breast implants that medical science at that time had failed
to support.
I think one way in which to make our efforts more focused and deliberate
is for the staff, if Leon agrees, to gather information about what, if
any, kinds of regulations govern or led to the creation of IVF clinics
and IRBs, so that we'll have a clearer understanding of the factual or
legal understandings that now govern those enterprises.
And my final remark -- and I make it final because to me it's especially
important -- is that we must allow markets to operate in this business.
We do not know enough. No regulatory body ever will know enough to manage
these things. If germ line technologies are to be employed, obviously
there must be some oversight as to which are appropriate and which are
inappropriate.
But with respect to those that are appropriate, people must be allowed
to make money doing this. Because if they're not allowed to make money,
the appropriate germ line strategies will never be pursued, and people
who might benefit from these strategies will never have the opportunity
to do so.
CHAIRMAN KASS: Frank, did you want to join in?
PROF. FUKUYAMA: In response to that, I think
there's a tremendous amount of work to be done. It was my intention, actually,
in parallel with my service on this Council to, you know, get foundation
funding to basically do a project, you know, that would look at biotech
regulation that would do precisely that.
I mean, I have an ongoing study group that would call in regulators from
the different agencies and simply to talk and inform ourselves about,
you know, current problems. For example, I mean, and I think there's probably
a lot of consensus that this needs to be done quite apart from the ethical
concerns that we're supposed to address in this Council.
For example, you take the case of individualized medicine. The FDA, you
know, as a result of completion of the human genome project -- the FDA
is going to have a huge problem in dealing with this, because you're talking
about medicines that are individually tailored to, you know, particular
genetic profiles for which the existing, you know, large clinical trial
model is simply not appropriate.
And, in fact, Catherine yesterday was saying that, you know, if you extract
a stem cell under her method, you know, by current FDA rules, you know,
that has to be considered a separate -- you know, a separate drug that
would require separate FDA approval for every individual for whom you
do it.
And, clearly, you know, that -- there is something, you know, really wrong
with that -- you know, that model that needs to be, you know, I think
very dramatically rethought. And so I think that, you know, one further
point -- I mean, since September 11th, there is a -- unfortunately a security
dimension to biomedical research that -- in this country that I think
we have not previously been -- I mean, we've been conscious of, but there's
a fellow that I know who is a former weapons inspector in Iraq, who is
actually trying to -- he now runs the Washington office of the International
Institute of Strategic Studies, but he is trying to organize the global
biotech industry to create a self-governance mechanism to prevent a big
disaster.
He was quoting me this one example, that there is a private biotech firm
in San Francisco that is trying to wrap a virus inside a bacteria in order
to get the -- you know, the virus past a person's immune system to obviously
deliver a therapeutic, you know, vector. But, you know, obviously, it
can be used as a bioweapon, and his particular concern was that they were
actually subcontracting major parts of this research to a lab in the Ukraine.
And he was saying that, you know, nobody in Washington even understands,
you know, the global biotech industry well enough to even realize that
this is a potential problem. I mean, he said he was sure that there is
nobody in the Defense Department that had any knowledge of this company
and what it was doing.
So, you know, there is also I think that -- you know, that dimension.
And so I think, you know, for a whole variety of reasons, this is a question
that needs to be looked at.
One issue that I actually had wanted to mention earlier, which is the
question of democracy. You know, in general, when you deal with highly
technical areas, like the regulation of biomedical research, what all
democracies do is to delegate responsibility to that to, you know, so-called
epistemic communities, and that's basically what this whole FDA system
is and the self-regulation that goes on within the scientific community.
And that's, you know, absolutely necessary because, you know, there's
a high entry price to even being able to have an intelligent opinion.
You know, it depends on scientific knowledge and background, and so forth.
And so -- and that's the way a lot of the regulation has happened up until
now.
I think the conceptual challenge is whether you can democratize in a certain
way -- I mean, I think that there are a number of reasons for thinking
that that delegation is going to be more and more problematic as time
goes on, simply because the technologies will do things that will raise
ethical problems that people in the democratic -- larger democratic society
will have problems. Not everybody, but -- and different people have different
problems with different aspects of it, and there won't be complete consensus.
But it'll be much more controversial.
And I think that the self-interest of the epistemic communities cannot
be assumed to correspond to the interest of the society as a whole. That
is to say, researchers have their own ambitions and goals. There is clearly
a private biotech industry that's driven by, you know, its desire for,
you know, profits, and so forth.
And so the question is: can you modify the governance structure such that
it is not a pure delegation? Obviously, it has to be, you know, substantially
delegated. But can you open it up to some greater degree of public participation?
And here I want to divorce completely my own views of what that -- you
know, what the rules ought to be.
I mean, I'm just saying procedurally it seems to me that we need to think
about whether there is a way of, you know, opening up that procedure and
democratizing it to a greater extent, you know, and taking it a little
bit out of the hands of the epistemic community to allow other societal
voices to -- you know, to participate.
And I think that there are some models for that. It's sometimes -- when
I've described this to people, they say very contemptuously, "What?
You're going to have an ethics regulatory agency, and so forth?"
But, in fact, you know, that is the idea behind the non-professional members
of IRBs, that you get, you know, social voices that don't have the same
set of interests that the biomedical research community does.
You know, the British agency also has similar rules for non -- you know,
professional membership in its oversight board. And so I think there are
-- you know, in democratic societies there are actually institutional
models where you can, you know, broaden the kinds of societal inputs that
-- you know, that go into it.
Now, Rebecca may be perfectly right that given the deep -- and, particularly,
the closer this gets to abortion and, you know, embryos, and so forth,
the harder it's going to be to come to any agreement whatsoever.
But I do think that, you know, and so it may not be possible to create
these institutions, but I think, you know, generically that's what we're
talking about. And then, there is some precedent for it, and so I think
we ought to, you know, think carefully about what that might look like.
CHAIRMAN KASS: Michael? Then I'll join the queue
myself. Michael Sandel?
PROF. SANDEL: Well, I appreciate very much Frank's
project, and I find it all persuasive. One small request that I think
would be helpful -- Frank has referred to the U.K. licensing system, which
applies to the full range of these, and I think it would be very helpful
for the Council to -- if there were a good account of that and what restrictions
they've decided on that could be distributed, I think that would be a
valuable thing for us to have, because there is a model out there -- which
we may or may not agree with in all of its aspects -- but I think we should
-- it would be helpful if we could have a copy of it or an account of
it.
The more general point, though, I would like to make is that it seems
-- it might seem as though Frank's emphasis on the regulatory aspects,
and Rebecca's, is a separate topic from the moral and philosophical arguments
we've been having.
But I think it's worth drawing out the -- some important connections between
the two, and to incorporate more explicitly some of the regulatory restrictions
we might favor into the philosophical account, the discussion, even of
the cloning issue, which we haven't really done so far.
We haven't gotten into -- for example, here are two ways in which the
discussions are connected. The slippery slope arguments that Charles and
other -- a few others have raised loomed large in the moral discussion
about cloning for biomedical research.
And there are those who take seriously the worries that lie at the end
of the slippery slope and also take seriously maybe even the tendencies
that Charles emphasizes, but who may think there are practical ways through
regulatory and licensing systems institutionally to prevent them. And
if that's true or plausible, then that makes a difference for the argument
about whether we ultimately endorse cloning for biomedical research or
not.
Insofar as there are moral/prudential arguments, then some actual accounting
of the prudential measures and licensing and regulatory measures is part
of the moral argument itself, not just a further topic for a future report.
A second way in which these two are connected, the regulatory and the
moral argument, goes to the -- remember, we had these three categories,
and group two were those people who kind of wrung their hands and had
moral qualms, but nonetheless wanted to go forward. And it includes those
people who in earlier discussions said there should be some respect accorded
the blastocysts, even though some of us don't regard that as a full human
person.
And then, the challenge comes from Gil and others rightly, well, what
does it mean to accord some measure of respect if you're prepared to take
it apart to kill it? How do you give actual institutional expression to
the respect?
And here's another area where including discussion of the restraints that
you might want to endorse and insist on, restraints having to do with
the number of days, having to do with the purposes to which it could be
put, having to do with whether the research could proceed if there are
already existing stem cell lines of that kind out there or not, which
the British case restricts, restrictions having to do with the requirement
of depositing the stem cell lines in a pool rather than privatizing them,
which I think the British one also includes.
It might be possible to make out an answer maybe not persuasive in the
end to Gil, but at least a substantive, a more fully developed answer
about how in practice people in category 2 would give concrete institutional,
practical expression to the restraints and to the restrictions. And this
would be a second area where spelling out the regulatory and licensing
aspects would be part of the moral argument, not a further consideration
to be dealt with in another report.
So I'm hoping that even in the report, which we don't have so far, on
cloning for biomedical research, it's possible to try to spell out, even
if in a provisional way, some of the regulatory restrictions that would
be associated with what we've been calling position two, those people
who take seriously the moral costs associated with sacrificing blastocysts.
And, well, what does that mean in practice, and how does that differ from
a view which would be indifferent to that moral dimension?
CHAIRMAN KASS: Thank you very much.
Let me make a couple of comments.
PROF. SANDEL: Could I add just one thing? The
Senate debate completely ignores this. There it's either for or against.
You're either for permitting the cloning for biomedical research or against,
and one way this Council could make a contribution by linking those regulatory
restrictions would be to show that there is another alternative.
CHAIRMAN KASS: Well, just -- I didn't want to
comment on that, but you -- since you came a second time, let me make
a small point. I mean, it does seem to me that thinking through the regulatory
possibilities is part of the prudential judgment about what to do, though
there is a kind of further question when one actually makes a recommendation
of what to do as to whether one says there could be regulatory possibilities
and, therefore, one judges this way, or one insists on being shown the
regulatory possibilities in advance before one signs on morally to a particular
position.
I mean, right -- I mean, it's one thing to say there's a theoretical possibility
that this could be regulated, and the British have done it, and another
thing to say this country, given its industrial structure, its decentralized
medical profession, its different view of how these freedoms should be
exercised, could do this but may very likely not.
So, I mean, I take your point absolutely, and we come explicitly to the
discussion of the public policy as opposed to the -- I'm almost inclined
to say merely moral considerations of this. The intersection of these
two things I think should certainly be part of our deliberation and will
be.
But let me speak more generally about the regulatory matter here. What
appeals to me about Frank's suggestion, though, Rebecca's very well-stated
cautions, and Jim's skepticism, and if Stephen Carter were here he would
remind us always about how things wind up regulating against their original
intent and worry about that.
Despite those worries, what inclines me to Frank's suggestion is this,
that we meet in this room and our predecessors met in comparable rooms,
and there will be other bodies like this to help people do their handwringing
as the train goes forward.
But it's not clear that these considerations which are not merely abstract,
philosophical ones, but are matters for the polity, for better and for
worse, should find their room for expression in various kinds of decision-making,
whether it be questions of funding priorities, whether it be the setting
of certain kinds of boundaries within professional societies, whether
it be governing the ethics of research, or what have you, whether it be
at the Food and Drug Administration.
And as I see it, and we are trying to gather information, and at least
the staff is slightly ahead of the Council, should the Council decide
it wants to go forward here, we've at least been doing some spade work
to try to find out what happened -- what's going on in the FDA that might
lend itself to the inclusion of considerations such as the ones we're
developing here.
What is there going on in the Patent Office that affects the pace of this
kind of research? What about the IRBs? And so we're trying to get background
information and invite people maybe to prepare papers for us should we
want to go forward on this area. But it does seem to me from where I sit
that right now the larger considerations that bring us together do not
have an adequate venue for consideration.
The FDA primarily had questions of safety. The Patent Office doesn't really
care about even whether something has criminal uses, as long as it has
legitimate uses, in deciding on its patents. And the IRBs, which are wonderful
on the protection of human subjects of research, if you can't force the
question into a sort of human subjects of research framework, you might
not be able to get to the concerns that we have.
And the public presentation on those bodies is likely -- is very often
intimidated, and so on. So I don't think we -- the existing structures
are such that the considerations we're interested in can find adequate
expression.
That's one point. So I think we -- it's worthwhile thinking this through.
Second, to pick up something that Jim Wilson said about the importance
of involving industry in these matters, what's really new in the 25 to
30 years since I've been thinking about this is we now have powerful groups
for going forward, not just the scientists in their laboratories doing
what they've always done, but these powerful commercial interests which
are, for the most part, unregulated.
And my sense of this is that it is in the industry's interest -- and we
need to persuade them that it's in their interest -- but I think it's
in their interest, in fact, to join this conversation lest some of their
cowboys produce the kind of disasters, the thalidomide or something of
that sort, in which restrictions come down and response to disasters that
will be terrible for them and terrible for us.
So we have begun to have some conversations to locate those kinds of people
who could come and talk with us, and at least enter into some kind of
conversation about what kinds of things they might willingly join in setting
what kinds of boundaries.
And, in fact, one of the theoretical questions one wants to put to them,
and we can test it out by putting it to our members here from the scientific
community, is, can one begin to think constructively about the kinds of
moral boundaries that researchers and technologists should observe, whether
or not they take federal funds? In other words, whether they work in the
private sector or not. And can one begin to think about this without threatening
the goose that lays the golden eggs?
If the scientists are always saying that any attempt at regulation, or
any kinds of restriction is simply threatening to our enterprise, then
I think they also are in danger of running certain kinds of risk to their
enterprise should disaster strike.
And it seems to me it's in everybody's interest to at least explore the
question of whether we can find, if not substantive moral boundaries,
at least procedures for considering these sorts of matters as the research
goes forward, so that the larger considerations enter, so that the profit-makers
are actually at the table, and that the working scientists contribute
in a way that doesn't stifle the research but respects that the moral
-- the moral sensibilities of the community.
So if we can't do anything like that, then we -- we will have a good time.
We might produce some documents that people will read. But giving efficacy
to these concerns where it really counts, I think we will just fail to
do that. Whether we can succeed in this venture, I don't know. This is
a high-gain, high-risk exploration, I think, because it's not clear we
can -- we know what to say at the end of this.
But because of its importance and its promise, I would be willing I think
to invest our time and resources, if we could figure out just how to proceed
in a practical sense. And it would at least help me, and I don't want
to pin anybody down on this, but it would be interesting for me to hear
-- I hope for all of us to hear how the researchers in the group would
respond to a request for a kind of inquiry on this.
So, Janet, and then Elizabeth, and Dan, if you will, too.
DR. ROWLEY: I have the impression, though I
don't remember precisely, that, in fact, in one of the National Academy
reports there was a suggestion that some kind of an advisory body or regulatory
body could be established.
Now, I could be mispresenting that -- remembering that from reading of
another report. But I think that just as the individuals involved in recombinant
DNA technology recognize both promise about the safety concerns in the
early '70s, and established the RAC, I think so, too, many members of
the present community involved in cloning also recognize many of the concerns
and issues.
And particularly, because they are so much more directly related to people
and the potential for uses than was clear in the '70s, that the biomedical
community would -- I would think, I would hope, would actually respond
positively to the suggestion that they be involved in the development
of a committee that would look at guidelines for these kinds of questions.
And I think that as well as looking to see what the British have done
-- because it isn't as though this is brand-new, others have done this
as well -- to look at other examples that have been successful. I noted
that John Gearhart did also mention the Canadians and thought the Canadians
had done even better than the Brits. So if we could ask staff to get information
on that, I think that would be helpful.
And I would certainly agree with Frank and with Mike and others that in
these committees that broad representation of other groups is certainly
important.
In the National Institute for Human Genome Research, we have the ELSI
Committee, which is the ethical and legal and moral implications of --
I don't know whether the S stands for science or what, but anyhow it deals
-- social.
So that is already embedded in one of the NIH committees, and a proportion
of the Genome Institute's research funds are earmarked for ELSI research,
so that the genetics community at least has embraced the fact that what
it does in the research arena is -- should be viewed by communities other
than just geneticists. And I think that that is appropriate.
While I have the microphone, I'd just like to go back to some of the comments
that Mary Ann made, because she brought up the question of, what are our
priorities? And it seemed to me the bottom line she said was these are
politically dictated, and I -- I wonder if, in fact, that is so.
You can say the priorities of where are we going are not determined by
political forces, but, rather, by events that are driven by others, including
scientists, engineers, etcetera, who come up with discoveries that then
have an impact on society. And what society is doing is responding to
these new areas and trying to figure out what kind of a response is appropriate
rather than society saying, "We're going to go and do this kind of
new thing." And so I would just question that.
CHAIRMAN KASS: Mary Ann, please, you want to
respond?
PROF. GLENDON: Just a point of clarification.
I didn't say they were politically dictated. I said it's a political question
and something that we ought to understand as a starting point to what
extent they are governed, as you say, by events -- that is, by default,
and to what extent there is intentionality.
CHAIRMAN KASS: Would you say another sentence?
Because I'm not sure everybody understands -- would understand what you
mean by "it's a political question."
PROF. GLENDON: It's a political question whether
a society likes the direction in which it is going, either by choice or
by inadvertence. It's a subject for deliberation in a democratic polity.
CHAIRMAN KASS: Thank you.
Elizabeth, please.
DR. BLACKBURN: Yes. I really very much want
to endorse what Janet just said. Leon used the phrase "all scientists"
-- I forget, but I think it's been very clear from the history that scientists
have had a strong voice in wanting to self-regulate -- the RAC being one
example.
And to answer your -- you said you wondered if there was something in
the National Academy's recent report on -- this was the report on stem
cells and the future of regenerative medicine. Included in our handout
were the first three chapters excerpted but not the last one, the findings.
But I have the original with me, so it -- let me read you the recommendations,
which directly are pertinent to this.
So the recommendation after finding six was a national advisory group
composed of outstanding researchers, ethicists, and other stakeholders
should be established at NIH to oversee research on human embryonic stem
cells. The group should include leading experts in the most current scientific
knowledge relevant to stem cell research who can evaluate the technical
merit of any proposed research on human embryonic stem cells.
The roles for the group could include evaluation of potential risks to
research subjects and ensuring compliance with all legal requirements
and ethical standards.
So I think that perhaps an implication that might have been taken from
Leon's phrase of all researchers, which the scientists are not interested
in self-regulation, I think that's -- this is just manifestly arguing
this is not the case, that there is serious interest in self-regulation.
CHAIRMAN KASS: Dan, please.
DR. FOSTER: Well, I think the idea of having
industry involved here is a very good one for dialogue. Most of these
-- most of big pharma have ethical committees associated with them. But
my view, Leon, would be in this dialogue that you probably ought to have
somebody from big pharma that is not so much -- they buy biotechnology,
and so forth, but they're not as much in it as they are in the small start-up
companies, and so forth.
So, I mean, I think that, you know, you get somebody from Tularec or Genetech
or something like that as well to come in -- would be very helpful to
-- both to let them hear what we had here and what their suggestions would
be about that. So I personally think that would be a very good idea for
us to do.
CHAIRMAN KASS: Thank you.
Mike, Alfonso, and Gil, please.
DR. GAZZANIGA: The shortest remark of this panel:
I agree with Janet.
CHAIRMAN KASS: Alfonso?
DR. GÓMEZ-LOBO: Yes. I want to voice a brief concern about the regulatory
model which consists in appointing committees. And I'll just do it by
mentioning the fact that some colleagues of mine, British moral philosophers,
have serious doubts about the human fertilization and embryology agency,
because, you know, who gets appointed there is really crucial.
And their criticism is that rarely, if at all, people who are known to
stand for protection of embryonic life get appointed. So, I mean, it ends
up being a kind of rubber stamp for a number of projects that are morally
very questionable. So I think that's something to keep in mind.
CHAIRMAN KASS: Who was it? It was Gil and then
Paul.
PROF. MEILAENDER: Actually, I think it was Paul
and then Gil, but I'll go ahead of him again, as I did once before.
Two comments, the one very brief. It seems to me if we're going to pursue
something along the lines that Frank has discussed seriously, we may need
to set aside the language of self-regulation. That's just clearly not
nuanced or sophisticated enough.
I mean, Frank talked about how you have to -- you do have to delegate,
to some degree, decisions to people presumed to have expert knowledge.
But there are questions about how much you delegate, and so forth, and
the language of self-regulation will not capture that I think, and we
need different language.
The other thing I was going to say is just it relates to some things that
worked their way through Rebecca's presentation responding to Frank. And,
I mean, what he has done is really nice, but I just never know how to
-- what I myself think with respect to a certain kind of problem.
It just seems to me the conversation will proceed much more easily with
some kinds of questions we might think about regulating than with others.
And what I mean is we have fallen into a pattern in this country that
isn't very satisfactory, but you understand why, with respect to certain
kinds of questions, say ones that involve embryos, for instance, where
we don't fund -- we don't use government funds in a way that would implicate
all of us in some way.
But we also don't say, well, no, you know, we're prohibiting it, and we
allow private research to proceed. That leads to sort of a chaotic, not
very satisfactory situation. On the other hand, it's rather understandable
why we've gotten there.
And if we were going to fund and regulate, once law does that it confers
a certain kind of legitimacy, and that creates its own set of problems,
then. And I don't -- I mean, I just -- I have never quite -- I don't like
any of the alternatives. I have never quite figured out how to get past
that problem.
It will be much more acute with some kinds of questions than others in
terms of the range of issues that Frank has drawn up. But that problem
of complicity that -- the legitimacy that law confers is always going
to be hard here.
CHAIRMAN KASS: Paul?
DR. MCHUGH: I want to -- I'm glad to follow
after Gil always. But I also am pleased to follow after him now, because
in relationship to what's being said about self-regulation, the -- in
the pharmacological and neuropharmacological realm, the largest organization
in our country is the American College of Neuropsychopharmacology. And
I'm the present sitting chairman of their Ethics Committee.
And I believe that it is a developing program in which issues that are
problems are seen first, and then later dealt with. And I think the process
and the willingness of such organizations is quite clear.
CHAIRMAN KASS: Well, I guess I'd like to underscore
in part Gil's point on this, too. The professional self-regulation --
there's a certain homogeneity of viewpoint as to at least what the domain
is. This is quite apart from any particular vexing question such as the
embryo-related questions would introduce.
But there is a certain kind of guilt mentality in those things in which
the larger considerations that come out when you have a group of this
sort talking don't generally get built into the conversation. I'm always
surprised by what I hear about the table -- that is to say, that very
smart and thoughtful people interested in the same topic don't see it
in the same way.
And if I simply hung out with, you know, the like-minded, professionally
or otherwise, the questions just wouldn't look the same, and the industrial
self-regulation, where all of these various institutions have their own
ethics committees -- I mean, it's -- you get what you pay for very often
in those places, and it's a very peculiar thing to have critics -- it's
like the company union very often.
And without impugning the judgments of anybody who works there, it is
somewhat odd to bring in house people who, after the due wringing of hands,
will endorse what the company is -- the most profitable course.
Okay. And then, finally, the RAC is a wonderful but very limited example.
It's limited by the fact that the question -- this touches on something
Frank said earlier. The question -- the RAC grew out of the concern which
led to the Asilomar Conference, in which, strangely enough, I think everybody
saw that they were somehow in the beginning -- at the threshold of the
genomic age. The word didn't exist, but that this was the beginning of
something very large.
There was anxiety about this very large thing. There were public critics
of this very large thing. And all of the anxieties were allowed to be
focused on the one question of the safety of the little recombinant organisms,
should they get out of the lab.
And there were, of course, local threats in Cambridge, Massachusetts,
etcetera, etcetera, that may have focused -- but, once again, the question
about the safety of the organisms, just as the safety of cloning, don't
go to the heart of what it is that one actually is concerned about once
the technologies are safe and ready for use. It's the use of the powers
when they're safe rather than the hazards of making them safe.
And one of the things at the Asilomar Conference, several Soviet scientists
were invited to this conference, and they sat in the front row and photographed
all the slides. They didn't say a word.
And because the scientists, in their decency and naivete, thought that
the only question under discussion was the safety of the microorganisms
that were being engineered for use, no one paid any attention to the implications
for possible bacteriological warfare that were implicit also in the kind
of research.
But there were other people at that meeting who somehow understood the
other implications. So it seems to me that these models that we have before
us are interesting, they're appropriate for their place, but one has,
I think, to renew the consideration in the light of our present circumstances
-- self-regulation, where possible, but with the input of -- with the
kind of input that's commensurate with the subject and with the stakeholders
involved.
This is not, by the way, to suggest that the recommendation in the stem
cell report would be inadequate. That wasn't meant to suggest otherwise.
Frank, and then maybe a couple of comments, and then we will move to --
if there are others who want to -- Charles, did you want in on this as
well? Is that a light? No. Frank, and then --
PROF. FUKUYAMA: Well, just on the question of
self-regulation, I wouldn't banish it from our lexicon, because it is,
you know, a possible institutional model. And I think in, you know, the
field of public policy there has been a lot of kind of theoretical work
done on where self-regulation works and where you need more formal types
of regulation.
And there's actually a lot of game theory behind this, because, you know,
generally speaking, self-regulation works when communities are relatively
small and homogeneous and, you know, where the kinds of issues that they're
regulating, you know, don't pass a certain kind of threshold with regard
to, you know, the politicization, and so forth.
So that, for example, in the standards world, there is just an amazing
amount of self-regulation all over the world in terms of, you know, coming
up with technical standards for all sorts of things. And this never reaches
a political level, and it's all done, you know, pretty much by insiders.
But there are other situations where you have heterogeneous interests,
where you have cultural differences, where you have national differences,
where the issues are more inherently politicized, where these kinds of
self-regulating informal mechanisms tend to work less well.
Just an example is the internet. The internet, when it was run by a bunch
of engineers, could be completely self-regulating because they all agreed
with each other. They all knew each other personally, and, you know, they
could make decisions among themselves. But as the internet has gotten
commercialized and more heterogeneous, that kind of solution tends to
work less well.
So I just think -- I mean, this is one of the -- you know, but there's
a lot of -- there's a big body of thought, you know, that has gone into
this more general question of when you can self-regulate and when that's
not appropriate.
CHAIRMAN KASS: It looks like we may have exhausted
this for today. Do I have the sense of the group that this is a topic
to which we don't make a definite long-term commitment at this point,
but we are interested in it enough to take it to the next stage, to gather
the information about what's happening in Canada and in Britain in this
particular area to invite in people from perhaps some of the bodies that
already do practice regulatory activity in the area of biotechnology?
And maybe set aside some time at the next or the meeting after next where
we go into this more deeply?
Charles?
DR. KRAUTHAMMER: We could also sort of think
of it as we may not want to look at this as an issue to be spoken of in
general, but to apply it to the specific questions as we come along. For
example, when we get to deciding on policy for cloning, it would be appropriate
to hear, for example, what Michael and others were talking about in terms
of regulating from those who want to go ahead and continue to make it
legal.
So I think it would -- rather than speaking of it as a global issue, I'm
grateful to Frank for introducing it, because we had really overlooked
it. But to take it in pieces as we go along issue by issue, and then we'll
-- by the end of that, we may have some idea of what a larger regulatory
structure would look like having examined a few examples of what it might
do.
CHAIRMAN KASS: Very good.
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