Friday, July 25, 2003
Session 5: Biotechnology & Public Policy:
Discussion of Findings and Identification of Policy Options
CHAIRMAN KASS: Good morning. Thank you all for your endurance
It was a very rich session and much to digest, and the conversation
on the stem cell monitoring will continue in the September meeting.
We know already that Dr. Zerhouni will be with us to talk about
the implementation of policy and give us an update on what's
actually happening out of the NIH. We're looking forward to
In this session this morning, "Biotechnology and Public Policy:
the Discussion of Findings and the Identification of Policy Options,"
we will be dealing with the two staff working papers that have been
presented in your briefing book.
The first of these papers on findings contains findings that are
distilled from the diagnostic document that was discussed at the
June meeting, and the second, some policy options, a paper prepared
in response to the council's request that lay out some general
options both for general institutional reform, as well as for certain
specific areas of concern, the latter derived really from and in
relation to the specific findings.
And the goal for this session is threefold. The first two, most
First, to move toward agreement regarding what we have found in
our diagnostic survey. That will be roughly the first half of this
Second, to move toward clarifying some of the relevant policy
options open for public discussion in the areas identified in the
And, third, looking toward a subsequent meeting to begin to see
if there are areas of common ground regarding some of those policy
options that this Council might be prepared to recommend in the
interim, while the longer conversation proceeds.
Our intention at the moment, subject to your approval and review,
is to issue some kind of document some time in the fall, the major
part of which will be diagnostic, and laying out certain of the
possible policy options for the public to continue to consider.
And if there are places where we can agree on specific recommendations,
we will do so even if it's limited simply to the matter of the
need for more information, review, and monitoring in selected areas.
I should say you have at your place a printout from the Web edition
of the morning Washington Post, where unsolicited we have
editorial support for our activity, unheard of in the newspapers
with respect to the workings of this Council. Please read it at
Before we start the discussion, I'd like to introduce one
new member of the staff, Adam Schulman.
Adam, would you stand?
Adam is a tutor at St. John's College and is working as a
consultant on the Beyond Therapy project for this summer, helping
to get that into shape.
So the first part of the meeting on the findings paper. I remind
you that these findings are an attempt to distill the outcome of
the diagnostic inquiry. To make it perfectly clear as the document
itself says, the listing of the findings is not intended to imply
anything in particular, indeed, anything at all that would require
public policy response.
And please note the place of ART in this document. This has been
stressed several times, and the purpose of this inquiry is not retrospective
effort to regulate ART. We've taken that up because it is the
gateway technology and the advent of new genetic screening possibilities
and the like; build upon that, find their home in that context.
And therefore, thinking about monitoring reprogenetics begins
really with thinking about the monitoring of this area of work.
I think we should probably go through the findings in toto and
then one by one, as you would like. This is not the place to do
the line editing. We want your comments on that when you go home,
but the basic question is: are these basically accurate findings?
And is there anything of importance that we have omitted?
And let me get some general comments, and then we can go slowly
one by one. And there are some people with special interests in
these regulatory activities, and perhaps if I have no volunteers,
I'll just call on you: Frank, Rebecca, Jim, Mary Ann.
Rebecca, do you want to start?
PROF. DRESSER: Okay. I passed on most of these comments
already, but let me say them for the group.
One overall reaction I had was that many of the problems, the
findings described in the document could be applied to other areas
of medicine, and so I guess I see two broad questions. One is in
what areas has this branch of medicine and innovative practice had
less oversight than other areas of medicine and, you know, what
problems does that create?
And then the second broad point would be: are there reasons why
this area of medicine should have greater oversight than other areas
of medicine? And if that's an argument, then what are the reasons
why this particular area of medicine needs more federal oversight,
that sort of issue?
So that was a basic question I had. I do think the fact that
many of these innovations have not received oversight for safety
and efficacy in the same way that drugs and devices do is an example
of where this has not received the same amount of regulation as
Now, one of the reasons is that they often involve procedures,
and procedures aren't regulated by the FDA. So in some ways
that's similar to surgery, but I guess I think that we should
remember that there's a baseline of sort of standard practice
of medicine and how the government looks at that practice and then
remember that this is a component of that in terms of asking what
kinds of oversight it ought to have.
CHAIRMAN KASS: Thank you.
Frank, do you have?
PROF. FUKUYAMA: Well, I think the summary is quite good,
and it does point to a lot of the conclusions that came out of the
last staff paper.
I guess there are a couple of things that we would need to talk
about a little bit further about why we're interested in this,
which in a way was addressed yesterday in the short exchange between
Jane and John Gearhart, and in a way the Post editorial states
it a little bit better than the staff paper, which is to say if
the concern is simply with the safety of existing IVF procedures,
I think you need to really make a case that the current levels of
safety — I mean, even if some of the statistics that were shown
to us yesterday were true, you know, that IVF produces twice the
level of birth defects, you know, of natural births, I mean, you
don't know what the baseline is. I mean, is that high or low,
or is that something to really worry about? Is that something that
can simply be dealt with with informed consent?
And, you know, those are serious concerns, but it's not clear
to me that that's sufficient to drive, you know, a major effort
to, you know, talk about regulation in this area.
And I think that somehow it ought to be clear that the kinds of
concerns that ought to be driving us are certain possibilities for
reproductive medicine that are not germ-line, you know, that are
not ten, 15, 50 years down the road, but, you know, possibilities
that are actually fairly realistic that either can be done today
or will be possible within the next few years.
I mean, for example, if you could take a stem cell and walk it
back and produce an oocyte, you know, from a male, you know, a stem
cell coming from a male so that a man could, in effect, you know,
become a mother, I mean, do we say, "Okay. Go ahead. Do it,
you know, if you want to"? I mean, is this something that
the society feels comfortable simply permitting to happen?
And that's the kind of possibility that I think does trouble
people. I mean, the Post editorial talks about a lot of
those things that came up at this conference, and we need an evaluation,
you know, also about what is going on in this area and how much
of this really is, you know, near term and how realistic some of
these possibilities are.
I think that that would probably help in setting the context for
why we're interested in doing this.
As I mentioned yesterday during the last presentation, I actually
think that there's still a lot more factual information that
we need to collect on all of these topics. For example, this question
of the FDA's authority to regulate the practice of medicine,
as I understand it, I mean, I'm not a lawyer, and so I just
have to believe what I'm told by other lawyers, but I am told
that actually if the FDA were sufficiently creative, its clear authority
over medical products would give it a gateway into actually controlling
quite a few procedures because there aren't any practices that
don't involve, you know, products, medical products.
And you can interpret the authority of the agency, you know, in
certain ways that would give you that authority, and again, they
just have chosen for prudential, kind of political reasons not to
There's a lot of interesting things that have been going on.
For example, we were told that the FDA should have used the Administrative
Procedures Act when it asserted its new authority over cloning,
but instead used "The Diane Rehm Show." That, in fact,
may be quite a clever political strategy on their part knowing the
problems of going through the APA. You know, if you want to informally
assert your authority, this may actually be a good way of doing
So there are a lot of mysteries really, I think, still of a factual
nature about what powers the government currently has to deal with
a lot of these sorts of issues, and I'll reemphasize something
I said at the last meeting. I really hope we don't get too
driven by the timetable of, you know, the fact that our mandate
only goes through November. I really hope the mandate gets extended,
and I hope that, you know, if we can get an early decision on whether
the Council's work is going to continue for a few more months,
that would be very helpful for this particular project because I
do think that, you know, serious consideration of these issues really
is going to require a lot more work on the part of the staff and
Council members and so forth.
CHAIRMAN KASS: Thank you.
PROF. GLENDON: Yes. I, too, think the findings are accurate
and helpful, and I think it's worth remembering that just as
many of these findings came as a surprise to all of us who have
a certain expertise in the field, they involve matters that most
members of the public are unaware of.
Most people, in spite of the fact that we live in a society that
in some sense is committed against heavy governmental intrusion,
most people think that somewhere there is somebody who is paying
attention to their health and safety. It comes as a surprise to
find out how much is unrelated.
And, Rebecca, I'm sure that's true in other areas besides
the one that we're studying, but this is the one that we're
studying, and I'd just like to illustrate this point with an
anecdote about a woman who came up to me. She was sitting at one
of our hearings, at our last meeting. She came up to me afterward,
and it was after I had asked a question of a provider of assisted
reproductive technologies. I said, "What do you say in your
interview with the woman who comes to you?"
And she said that she and two of her friends had been in IVF programs,
and that no one had ever spoken to them about the risks involved,
the likelihood of success. The interview consisted of, "you
really want to have a child."
And I think the assumption, the background assumption, of a lot
of these people is that somewhere somebody is looking out for me.
Somewhere there are governmental agencies that do keep an eye on
So I think just on this part, this staff working paper, the part
about findings, it's very important just to do what our mandate
tells us we're supposed to be doing, and that is raise the level
of public awareness and deliberation.
CHAIRMAN KASS: Jim Wilson, do you have something on this?
PROF. WILSON: I did not have anything to say, but I will
try to invent something in response to your request.
PROF. WILSON: I feel very much as Frank and Mary Ann feel.
To me the most interesting part of this is the distinction we have
to keep in mind between regulation and monitoring. I do not have
an ideological objection to regulation properly designed and properly
applied, but I'd like to know the factual world to which it
is applied before it is applied so that we can form some sense of
the costs and benefits of various regulatory schemes.
And the lack of monitoring, the lack of carefully done longitudinal
studies that follow children having gone through various procedures
to me is quite disturbing. I'm sure in other parts of medicine
we may find that, although the various parts I know something about,
largely having been a patient rather than a practitioner, is that
there's a keen attention to what happens from longitudinal studies,
and good doctors, which are not all doctors, take into account these
findings in explaining the costs and benefits of different courses
of action when you confront them, and that's highly desirable.
So that before I would want to design a regulatory structure,
I would like to encourage very firmly the use of monitoring studies
to follow people from ART, particularly those using ICSI and PGD
and the newer technologies so that we can find out what happens
And the argument for doing this firmly, as opposed to doing it
in other fields of medicine, is that we are talking about the lives
of babies, and we have a special obligation to figure out what the
costs and benefits of these procedures are.
CHAIRMAN KASS: Thank you.
DR. ROWLEY: Well, I have a number of comments about the
paper. I think that it certainly does reflect the areas in which
we've been discussing quite effectively. I think it's quite
helpful to look at each one of these subsets and then try to figure
out why is there no uniform or comprehensive data collection.
And as I pointed out yesterday, this is a very costly matter.
So the lack of data are direct results of the fact that there is
no funding for this area of research, and I think that that actually
has an influence on many of the other areas that are included within
this staff document.
Looking at technologies and trying to improve them, following
up on what Rebecca said, if you're going to, say, look at a
series of techniques, trying to see which one is the best, this
involves experimenting on embryos to see which one leads to, from
whatever measures one can use, the best growth or you can't
go and do these experiments in patients, which is what you would
do in other scientific matters, because you can't just give
five patients embryos treated this way and five that way and see
which is best and then move forward.
So this is a very difficult area, but we give it no money at all.
So how can you express progress in some of these?
And the same, the concern about the fact that these techniques
are not tried, say, on primates. Primate research is exorbitantly
expensive, and there's nobody to pay for it. So we are the
victims of decisions made years ago not to fund this research.
There's another area that was touched on yesterday, which
I think is something that we should try to help at least bring to
the attention of Congress, and that is the inequality of access
to these technologies because poor black couples who might want
to have a child, unless it's in a state where there is coverage
for this, have to pay for this themselves, and this is thirty to
fifty thousand dollars, and they don't have this kind of money.
So our health care system mitigates against wider use of this.
Our health care system also encourages the implantation of multiple
embryos, which everyone agrees is a bad thing both for the embryos
and for the mother, because of the way we finance health care.
So I think it's important that we not get into the mindset
that it's the practitioners of ART who are doing all of these
things which we find less than ideal and somehow they're doing
things less ethically without looking at the causes of some of these.
And I think that that's extremely critical.
And I want to just close with pointing up Rebecca's first
comment, that there's less oversight, and I'm not sure that
that's so, of this area of medicine than others because who's
looking at how you're doing appendectomies and who's looking
at how you're treating diabetics?
There are general practices, but I'm not sure that we have
complete databases on that, but then the question also is does it
merit it, and some of what Frank said, it says that this is a unique
area, and therefore, it merits some kind of consideration. And
one of the questions is what kind of consideration, oversight, to
use Jim's words, monitoring does it require.
CHAIRMAN KASS: Rebecca.
PROF. DRESSER: Just to respond, when I said less oversight,
I meant that innovations do not go through the FDA regulatory process.
Now, other procedures, in surgery, appendectomies, they don't
either, but a new drug for diabetes has to go through the FDA, and
it has to be tested, and all of the studies have to go through IRBs.
And so I do think there is differential treatment there.
Just a couple other points to throw out, the barriers to funding
in this area put in place by the congressional ban on funding destructive
embryo research would prohibit federal funding for some research
that you might like to do to demonstrate safety in this area, but
I don't think it would prohibit, say, a longitudinal study following
children who were born from IVF.
Now, I don't know if there has been a policy decision at NIH
not to fund that kind of study or if there's some other agency
problem with that, but I don't think the statute itself would
apply to all research that we would talk about here.
So just a couple of points.
DR. ROWLEY: Well, it's my impression the CDC is empowered
to do something, but I don't know exactly the scope of that
and the time frame of that, and you can say they're an appropriate
agency to undertake this because they're involved in other studies
in epidemiology, though the subject matter of this is a little different
than they've been involved in before, but it would certainly
be helpful to know what the mandate of the CDC is or how they're
proceeding and what questions they're asking.
Because we've pointed out there are a number of questions
they may not be asking which we think would be very essential to
gather necessary data.
CHAIRMAN KASS: On that point, Janet, I think in the diagnostic
document we did list what the federal statute requires the CDC to
do in this area, and in the policy options, there is some identification
of the kinds of things that might be added if we were so inclined,
but we can talk about that when the specifics come up.
Frank, did you have something?
PROF. FUKUYAMA: Yes, I have a slightly different point
to make. I've tried to peddle this idea to a couple of people
like Gil yesterday. So I'm interested to hear what his reaction
will be, but I think there's another independent reason for
wanting to have more monitoring and oversight over this whole area,
which has to do with this whole question we've been talking
about in the Council right from the beginning about what it means
if you believe, like I do and a number of other council members,
that an embryo has some intermediate moral status that's not
the equivalent of an infant, but is not, you know, just a mass of
cells. How do you, you know, publicly recognize that or write that
into law or grant that status?
And I think that, in fact, this kind of regulation would be a
recognition of that moral status, and I'll just give you an
example of that, which is the way that we treat dead bodies.
You know, if your Aunt Minnie dies, you can't just dump her
body in a dumpster. You can't render it. You can't turn
it into food. You can't reprocess it. You can burn it, you
can bury it, you can do a lot of other things with it, but the government
takes a very active role in, you know, setting rules and limits
on the way that you can treat this object.
And it seems to me that the cadaver in a way is a good analogy,
you know, for some other object that has an intermediate moral status
that we do not regard as having political rights and so forth, but
on the other hand, we don't regard simply as, you know, personal
private property that is completely alienable and so forth.
And it seems to me that one of the things that society says if
it sets up a system, for example, as existing in Great Britain where
every embryo that is created the government keeps track of, is that,
you know, in a way it's saying these things are important objects,
and even though we can use them for scientific research and destroy
them, we don't think that they are simply things that can be
disposed of at the whim of, you know, private individuals and that
there's a public interest in keeping track of all of this.
So I think apart from all of the public policy issues about safety
and, you know, whether we want to put limits on certain kinds of
practices, simply the existence of a monitoring system itself it
seem to me, in a way, goes to answering — because this question
is constantly being posed within the Council as well. Okay. If
you say they've got this intermediate moral status but you're
willing to destroy them, you know, what does that mean, and I think
this is one possible answer to that.
I mean, what it means is that we care really what happens to every
one of these individual ones even if some of them are being used
for scientific research.
CHAIRMAN KASS: Let me ask that we bracket a response to
Frank's comment only for this reason. He's really dealing
with the question of possible recommendations and policy options.
I would like to see if we have exhausted the comments on the findings
themselves so that we can take those things up separately.
PROF. DRESSER: Just one more question that might be worth
talking about. This issue of access to ART, there is a finding
that's indirectly critical of the fact that there aren't
any laws or policies that provide access or take a position on that.
That's a hard question for me because we don't have, except
for emergency care, we don't have laws that provide any kind
of medical care to everyone.
So I think I would want to at least think about access to ART
in the broader context, and in terms of setting priorities, going
back to yesterday, I think there are some tough issues there, and
I don't know if we want to wrestle with them, but I think definitely
it is not for me an automatic recommendation or judgment that everyone
should have access to these things.
CHAIRMAN KASS: Mary Ann.
PROF. GLENDON: This is kind of on the borderline between
the two papers, but it seems to me that it does belong under findings.
One of the findings ought to be that these matters, many of them,
are regulated in other countries of the sort that we generally compare
ourselves with, other countries at comparable levels of social and
economic development, that experts in those countries are somewhat
surprised that we don't regulate.
CHAIRMAN KASS: Anything further on the findings themselves?
DR. McHUGH: I have a completely trivial point to make,
but perhaps it's useful to make this point.
You frequently use the word that I happen to like about the description
of this, namely, reprogenetics, and it may be that we're at
a point now where a term of this sort which grasps this discipline
enough so as to talk about it rather than going just from element
to element would be something that we'd like to recommend to
people. A word like that would be useful.
CHAIRMAN KASS: No, thanks, Paul.
In fact, as some of you will remember, we floated that term late
in the process of preparing the cloning report. Its appearance
in documents prior to its emergence in this room was troubling to
some people and it was stricken.
But the Hastings Center's report on these regulatory activities,
we heard from Lori Knowles about over a year ago, I think. That
document will appear, I think, in the next issue of the Report,
and I think they've got reprogenetics front and center in the
And I know that Kathy Hudson's group is using it as well.
So maybe this is becoming not just a neologism that people worry
about. We don't want to be behind the times, but —
DR. McHUGH: Let me just say that the advantage of it to
me anyway is to not only grasp the things altogether, but also talk
about how other elements that go on in the realm of reproduction
and even in the realm of obstetrics might have ultimately come into
I think I've mentioned to the Council before that I take care
of a very sizable number of young women who have been fundamentally
distressed by the triple test for Down's Syndrome that gets
employed early on in pregnancy at a particular time. I think you
know about that.
What that does is the statistics over time say to the young woman
that her chances of having a Down's child change from something
like one in 700 to one in 250 and so, therefore, they should go
on to an amniocentesis and various other things.
Now, whether they're interested in abortion or not, this test
produces in them a most distressing state of mind. Most of them
as you see will have normal babies, and yet the genetic counselors
are there saying, "You have the classic presentation for a
Down's Syndrome child." Even when they have an amniocentesis
they still worry about it until that baby comes. They then worry
about it in every other baby they have, and they talk to people
like me about what this means.
Now, in France, for example, they insist on all pregnant women
having this test, and it's slipped up on women in America, in
my opinion, always with the idea, well, you wouldn't want to
have a Down's baby as though you begin with that assumption
and burden women tremendously in their pregnancy.
And that's an issue of reprogenetics that would ultimately
be grasped if we had that concept in mind.
CHAIRMAN KASS: Okay. Let me make a couple of comments
myself in response to the things that have been said, all of which
I think are well taken and could be easily incorporated in the revised
version of these findings.
I do think several people, Rebecca, have spoken to, given multiple
reasons why this area (a) was the area that we set for ourselves;
(b) it is an unusual area of medicine in that new babies are produced,
and there are things here that are not strictly just therapeutic
that have raised some kinds of concerns in the broader society.
And I think if not at least in the findings, certainly in the
introduction of the diagnostic document where I think, by the way,
some of that material already exists as to why we're taking
this up, that could be strengthened.
I think the distinction between regulating and monitoring and
the tremendous importance of getting a lot more factual information
before anybody proposes anything restrictive, I think, is crucial.
We are at a very early stage of this process, to be sure, and I
think that's the spirit of the enterprise altogether from the
And also I think the economic arguments can be beefed up in the
presentation both to indicate Janet's concern, but also to suggest
that it's not clear that one can somehow deal with this particular
question of economics and access separate from the larger ones,
at least to flag that question.
And finally, I do think, Janet that I would side with Rebecca
to the extent to which some of the things that we would be interested
in getting information about we could get information about and
seek information even in the absence of federal funding, however
desirable that might be.
I mean the longitudinal studies; it's costly. But if people
cared enough about this, I mean, there are ways to get it done.
But I think somewhere between those two points I think we can make
that perfectly clear.
The government regulates, even regulates, not just monitors, certain
things that it doesn't fund if there is sufficient interest
in doing so, and certainly the information gathering in the thing
there is that we need, I think, could be encouraged.
Are we prepared to move on?
By the way, if anybody has thoughts that occur to them when they
get home on these things or details on the drafting, by all means
we would like to see them.
Let's look at the second staff working paper, some policy
options. And here, as the introduction to the paper indicates,
we have in a way two purposes, one, to simply lay out the alternatives,
both with respect to the possibilities of institutional reform,
things that it's quite clear we're not in the position to
make any recommendations on in the absence of a lot more study,
but at least we can identify some of the alternatives.
And then in some of the substantive areas of concern of the sort
the findings have articulated, what are the various kinds of things
that could be considered if the public were so interested to address
Secondarily, but really more for the next time we talk about this,
to see whether there are any specific actions or policies that the
Council might wish to recommend as an interim measure while the
discussion goes forward.
And here, once again, this is again really more for later. Given
the areas of division, this whole discussion could come a cropper
over those matters which divide us. Nevertheless, the exchange
between, for example, Michael Sandel and Richard Doerflinger at
the last meeting indicated that there are lots of areas of mutual
concern and that the fact that there are some things that might
have to be, at least for the time being, off the table.
It shouldn't preclude our trying to find those things on which
people of common sense could agree and maybe even unanimously.
So I hope that the spirit that would govern these discussions
is at least as much a search for common ground as it is to make
sure that the various alternatives are stated with as much force
and clarity as the public has a right to expect from a group of
So let's look at the second working paper and the various
policy options. To remind you, they've really been organized
around the sort of larger institutional questions, the four institutional
options of: a new agency; the augmentation of an existing one; specific
congressional action; and using federal funding as a regulatory
And then the substantive options having to do with the safety
and well-being of children, the possible limits on what could be
done by way of implantation of human embryos for research, improved
or equal access, the non-disease related uses of genetic screening
and embryo selection, germ-line modification, and the various things
having to do with commerce. And then the research involving destructive
research on early stage embryos.
Those are the seven areas, and the series of policy options are
out there. And let me just open the floor for discussion without
PROF. WILSON: I'm not persuaded that we're at
the stage in our knowledge where we are prepared to describe any
institutional option. We have several available. Each has some
benefits; each has some cost. The chief cost in all is that they're
concerned with other things, and in my experience adding a new and
very different task to an existing federal agency almost insures
that that new task will receive relatively low priority unless it's
supported by a large body of information conveying the fact that
this is a very important matter where a regulatory arrangement of
some sort may affect human lives in a desirable direction.
So that though I'm not opposed to designing new institutional
options, and we may well come to that, I would prefer focusing as
much of our discussion on the substantive issues as we can.
CHAIRMAN KASS: That said, Jim, could I invite you to comment
on not so much about what we're going to recommend, but the
adequacy of the articulation of the various issues and the alternatives?
I mean, is this a good beginning in the laying out of those options?
And if they can be improved, have you suggestions?
PROF. WILSON: No, it's a very good beginning.
CHAIRMAN KASS: A man of few words.
CHAIRMAN KASS: Good ones.
PROF. FUKUYAMA: Yeah, I think the one major option that
is really not represented here is a much higher level of self-regulation
on the part of the affected industries, the ART industry and the
part of the scientific community that is — in fact, Gerry
Schatten, I believe, when he testified, said that we need an Asilomar-like
process within our industry. I mean, they do self-regulate already,
but presumably this option would involve a new effort given the
new technologies that are coming down the line to really impose
a tighter set of rules and different enforcement procedures and
And, again, I mean, to evaluate this I think it would actually
be helpful to have an economist, you know, look at this because
when you look at the viability of something like self-regulation
within a particular industrial sector, it's all a question of
understanding the incentives, and it involves a lot of game theory
and things that can be analyzed fairly readily if you have the right
But I think it is an important option and certainly the option
that the industry will favor above any of the ones that are laid
CHAIRMAN KASS: Janet.
DR. ROWLEY: I'd like to make two comments. One is
the follow-on with Frank's, and as I'm sure you're all
aware, the medical profession does have a number of societies and
colleges that are each one associated with a particular medical
discipline, and these are all put together under the rubric of the
American Association for Medical Colleges.
And so looking to see which ones people think function most adequately
and then giving their both advice but also their experience on this
matter of self-regulation might be helpful to us, and so we could
certainly consider having someone from that group come and talk.
I do want to speak in favor of Jim Wilson's view that —
and I realize you agree yourself— that gathering more data
to see what the situation is before we try to figure out how it
ought to be regulated would be a very wise approach.
And the last comment I wanted to make is that as we've heard
very early on in our discussions, there were a number of panels
that have been advisors to NIH on some of these matters. Each panel
recommended that there be an oversight body established, and they
were actually fairly explicit about what kind of oversight body
should be established.
That's one of the reasons that I asked Lori Andrews a question
yesterday, because the RAC is such a body and would a comparable
body with some oversight responsibility in this area be appropriate,
and clearly her answer was that it was okay to have such a body,
but it shouldn't be at NIH.
CHAIRMAN KASS: Thank you.
DR. McHUGH: I want to back up both Jim and Janet on this
because I also believe that some kind of institutional organization
has to be formed to oversee this matter, but it's perfectly
true that unless the American public realizes that there are lots
of things at stake here, there will not be the energy for this.
There is a little sense that comes both from the RAC experience
and from the British experience that unless the scientific community
begins to feel that the villagers have their torches out and are
going to come and burn down the laboratory that nothing will happen.
I'm very encouraged by what we see in the Washington Post
today, that the people are beginning to, like the British people
when they discovered that there was genetic changing in their food,
then they terrified the scientists to make sure that they did have
regulations put in place.
I want us, as a body, and perhaps others as well to remind people
that there are awful things that could be happening out there if
we don't have oversight, and that the oversight should be opened
and developed, and the RAC is a perfect example not only in its
genesis, but then actually in its success in managing things, monitoring
things, and ultimately controlling things.
CHAIRMAN KASS: Two things before the scientists come to
correct you on this. First of all, I don't think it's the
purpose of this body to get the people out with their torches.
CHAIRMAN KASS: Second of all, and this ties up with Frank's
point, the RAC is the legacy of a warning developed by the scientific
community itself, and while we have discussed this at some length
and my view is that the RAC and Asilomar are interesting but only
partially relevant models because they have, in fact, by design
confined their attention primarily to the questions of safety where
we have additional interests here, nevertheless it seems to me we
cannot think about going forward in this area without the active
participation and, in fact, the leadership of the scientific community
and the biotech industry. Otherwise what one is going to have is
One has to, I think, mobilize enough interest on the part of the
general public so that people care enough about this to perhaps
make it clear that these things might be urgent, if they are urgent,
but I don't think that the spirit is the spirit of combat and
DR. McHUGH: Well, I agree with you, of course, at one
level. I just mean at some point people have to be feeling that
this is an inspired enterprise, and it relates to the future of
people in America and that it's an important thing.
I agree that, of course, the RAC was something out of the scientific
community, but I don't think anyone can deny that the issues
of the people of Cambridge, Massachusetts, and their concern for
what could have happened with recombinant DNA played a role in exercising
the scientific community enough to do what they did.
CHAIRMAN KASS: Point taken.
PROF. BLACKBURN: A fairly general comment which arises
from what you said in your introduction and from the document in
our discussion. What I'm sensing is that — well, my feeling
is that this is important enough that we should be thinking about
the sorts of principles of governance, in general, and you know,
if we think about governance and setting into place how checks and
balances are assured, then I think that, you know, the fear that
we're sensing is that some group will grab control of this process,
but if the governance of it is set up in such a way — and
I'm obviously speaking way out of my expertise — but if
the governance is set up in a way that people feel, yes, institutionally
it does have the checks and balances that do allow the different
views to be heard and all the information to be taken into account,
then you know, I think we have the makings of a process that will
be better and addresses what you're saying, that there may be
areas of consensus that can be reached, and if they can't be
reached, that at least there's a confidence that there's
a process by which the views get heard, and that's built into
whatever governance, you know, ends up dealing with these areas.
CHAIRMAN KASS: That reminds me — Mary Ann, please.
PROF. GLENDON: Well, I just wanted to say that one of
the great merits of the staff work on this paper has been to put
before us the diversity of the options that are available under
regulation. I think we have to do whatever we can to dispel the
idea that regulation always take the form of banning or not banning,
funding or not funding. I think this is just excellent work in
showing that regulation can encompass, as Frank said, monitoring,
gathering information, a whole spectrum.
And the techniques, the art of the matter of regulation, the techniques
have to be properly matched with the problems, and they will be
Having said that, it seems to me that some of the matters raised
here are ripe for consideration with regulations of fairly familiar
types. I would say regulation under the general heading of consumer
protection is well known to all of us, and consumer protection sometimes
just takes the form of providing information.
So, for example, I mean, a couple of areas that seem to me ripe
for moving ahead, areas where we have sufficient information to
move ahead, would be these informed consent suggestions on page
8. After all, with IVF we have a multi-billion dollar industry
that is, we have now discovered, virtually unregulated, and ordinary
application of consumer protection, laws, and principles would suggest
at least the provision of more information to people who are increasingly
clients of this industry.
And just another issue that is unrelated to that, but I thought
we shouldn't lose track of Frank's interesting analogy to
the way our society treats that human cadaver, and I just wanted
to add as some support for what Frank said that there are many legal
cases in the states which specifically say that no one can have
a property right in a cadaver. The next of kin have certain rights
regarding manner and place of burial, but people who have tried
to make the claim that they own the cadaver have, as far as I know
— I don't know of a single case that has recognized a
CHAIRMAN KASS: Bill May and then Dan Foster.
DR. MAY: Sometimes plea for more information can give
the impression of a covert argument for delay: "We don't
want to really do anything."
But Jim has offered the important plea that we need more information
so as to know (a) whether regulation is warranted and (b) what kind
of regulations make sense. This gives a kind of important instrumental
value to monitoring.
Monitoring also offers a kind of warning that the society cares,
that the society is watching, and thus it begins to serve a kind
of cautionary regulatory function even if you don't put in the
train actual regulations, it can under certain circumstances.
Yes, reporting and so forth can become pro forma, but on the other
hand, it begins to say something, and in a way maybe this paper
needs to talk more about the deeper moral justifications for monitoring.
As Jim put it very simply, hey, we're talking about babies.
You really want longitudinal studies. It's very important.
We're talking about human beings or, Frank's point, we're
talking about preimplanted embryos which have an intermediate status,
and it deserves being watched.
Monitoring, to steal from old Arthur Miller, means attention must
be paid. Not to monitor in areas like this means literally carelessness.
The society does not care. As long as it's done in the marketplace,
anything goes, and the society at large does not have to firm itself
up to pay attention.
So this kind of monitoring grows out of care in some sense that
attention must be paid, and I think more needs to be developed along
this line in this document. Otherwise, reading through this document
lots of options and so forth, and we need more information.
That doesn't quite answer what the Washington Post
was hoping for in this statement.
CHAIRMAN KASS: Bill, thank you.
Can I make a response? Because I think absolutely well taken.
Mary Ann, I think, at the last meeting asked that the document
have, in the spirit of toward a richer bioethics, that one not simply
play engineer and lay out the alternatives, but that one discuss
in some kind of thematic way exactly the sort of thing you're
dealing with and the sort of thing Elizabeth is asking for, namely,
some kind of reflection about the meaning of monitoring and regulation,
specially in a country such as ours.
The place for it, I think, is probably not at the statement of
the findings or only in the place of policy options, but even could
go very early on in the document as a whole. And it is, I think,
our intent to have such a thing, and it's my hope that we can
tap several members of the council to help us with the drafting
of that. There are people around the table who have much more experience
both in terms of political philosophy, the area of regulation, and
even this very beautiful formulation of what it means to monitor
and to attend and to care.
I think it would be unusual in a document on regulation and in
the spirit of the kind of work that we do to have such a thing in
Do you want to pick up on this point?
PROF. SANDEL: Yeah, on this. Is that all right?
CHAIRMAN KASS: Would you? Thank you.
PROF. SANDEL: I heard two things in what Bill said, but
I may not have heard correctly. One would be satisfied by language
that reflected on the meaning of monitoring.
The other I thought was a suggestion that a call for monitoring
would be a reasonable aim that might not be subject to the controversy
that you said we should avoid and that might not be subject to the
long time it would take to develop and to consider actual institutional
arrangements and so on.
Did I hear correctly?
DR. MAY: Yes, yeah, yeah.
PROF. SANDEL: And if so, could you, Leon, or might others
address the second part of the suggestion that this might be a reasonable
proximate aim given our limited time horizon and so on?
CHAIRMAN KASS: Well, the question of the limited time
horizon is open because Frank has raised it. I think we have a
short-term time horizon, and I regard this as a preliminary inquiry,
diagnosis. But we wouldn't be undertaking this enterprise if
this group as a whole didn't think that there was some reason
Some people care to the point of anxiety. Some people care simply
in the sense of to pay attention and to think this is important,
and my guess is — I'm guessing — that if one formulated
the questions properly, there might be unanimity around the table
that we would like to have more attention paid officially to Items
1, 2, 3, 4 and 5.
We would like to know about the well-being of children. We would
like to know about the informed consent procedure. We would like
an accurate accounting of the question of the costs, a variety of
things of that sort. The reporting on the uses of PGD that don't
have to do with disease if there are any, and the like.
My guess is we might be able to find some kind of an agreement
in a call for the paying attention, and my hope is that if there
are such things, that they are the expression of an ongoing concern
at this particular time that might even be given some effect even
as the longer term question of what kind of larger institutional
reform might be desirable be a subject of a much more extensive,
thorough and careful inquiry.
PROF. SANDEL: Just a question of clarification. Would
it be going beyond where you think we should go now for reasons
of controversial reasons of time to have the staff develop as part
of the completion of this regulation, interim regulatory report
to suggest ways and to produce a call to monitor the creation and
disposition of embryos in IVF clinics in the United States?
CHAIRMAN KASS: Yeah. Without getting into the details
of the substance, the motion is first the diagnostic document, then
the findings, then the laying out of the possible policy options,
and then next time we visit this topic, it's my hope that the
staff, having consulted with all of you, would be able to put forth
a series of possible propositions, of which that would be one, to
see whether — looking for the common ground.
Now, is it your suggestion, Michael, that we take that up now
and see whether there's agreement on it?
PROF. SANDEL: Well, I wasn't so much addressing that,
though that might be a worthwhile thing to discuss, but really whether
you saw within — you've emphasized you want to delimit
the regulatory project for reasons of time and of controversy, which
I understand and I think all of us understand. And so I was just
asking whether a relatively modest proposal of this kind would be
too ambitious given the time and controversy constraints —
CHAIRMAN KASS: Not at all.
PROF. SANDEL: — that you have.
CHAIRMAN KASS: No, not at all. In fact, in the last paragraph
of the italics part of the beginning of this paper there may be
matters where nearly everyone is in agreement about the need for
more information, for improved oversight, or for specific reforms
and action. Using this document as the point of departure, we would
like to discover any such areas of common concern and agreement
and whether there might be certain actions the Council would recommend.
And that, I think, would be the agenda item for the next time
we visit this topic, probably in September. So we have one session
where the staff has, after consultation, tried to put together a
list of such common things to see whether they are, in fact, common.
Dan Foster is patient; has to put up with the loquacious characters.
DR. FOSTER: One of the things that occurs to me in looking
at the overall documents about proposals is this. One large component
of what we're talking about is really not novel, and that is
that medicine always is looking at outcomes. I mean, so we reexamine
the use of estrogens and progestins in women long after it has been
accepted that it would protect against heart disease and so forth,
and we find that there are other questions. This is a monitoring
system, and people have looked to see if what was thought to be
truth is true.
And so it doesn't take very much to say what needs to be done
in terms of in vitro fertilization and so forth. There's
quite a large experience of it now, and it would be fairly easy
to see what we need to find out what the long-term consequences
are. The structure of this does not really require much intellectual
And as a consequence that may be something that's different
from the regulatory policies for things of the future, that is,
what we're going to do about gene therapy, germ-line therapy.
All those things are new, and as a consequence might require something
more distinct and novel than the first part of this.
And it would seem to me that conceptually we ought to make that
differentiation, and the first non-novel thing that we ought to
follow doesn't require — you might say where you're
going to house this and so forth, but it doesn't require anything
other than common sense to say that we need to find out what's
happening. Is it true that these children will have more complications,
more diseases, and so forth?
It's going to take time to do that. So I would sort of in
my own mind want to separate out the immediate things that are not
novel, that we have many multi-center trials and other ways to figure
out how to do, and that could include what Michael says. We're
going to account for all of the embryos right now.
I think where the big problem is going to come is for the future,
those new things that are coming along and where that ought to be
housed, and so the only point I'm trying to make is that I think
that for me it might be a dual recommendation here, one that really
is immediately applicable, and then the other is going to require
considerably more thought, whether that's going to be a RAC-like
thing or whether it's going to be at the NIH or what it's
going to be.
So I think we could move ahead very quickly on some of the things
that we need because that's what people are already doing and
have done and will continue to do.
I mean, we do lumpectomies or mastectomies. You know, we just
monitor and find that out.
CHAIRMAN KASS: That's a very useful distinction.
Gil was on the list and then Rebecca. Gil Meilaender.
PROF. MEILAENDER: Two things. One, I mean, sometimes
in a group you struggle forever to arrive at something that, in
fact, if you just sort of voted on it at the start everybody would
have agreed on, and I do think to some degree with part of what
we're talking about that's true.
With respect to the idea that more information in the sense of
good studies is needed, conceivably even in terms of Mary Ann's
consumer protection language. That doesn't answer Janet's
who pays question, you know, exactly where this should happen, but
I don't sense a lot of disagreement on that point.
The second point I wanted to make just as a larger issue having
to do with regulation understood more expansively than that limited
area on which it seems to me we probably actually have a good bit
of agreement, Mary Ann had described it as needing to know that
somebody is looking out for my interests.
But I think there's a tricky matter here. There's a good
bit of evidence by now to suggest with respect to the recombinant
DNA issue that, in fact, as opposed to arriving at something intended
to look out for the people's interests, it was a strategy designed
precisely to remove the question from the realm of the people and
their elected representatives so that looking out for my interests
can sometimes come to mean deciding what my interests are, and that's
a different matter entirely.
So I want to make a fairly sharp distinction between some of those
fairly basic questions on which I think we have a good bit of agreement,
even if some puzzlement, about kind of who would fund such research
and so forth, and larger questions about regulation on which I think
not only we're not sure, in Dan's terms, kind of exactly
what the questions would be or who should look at the, but even
what the best way to deal with them that really qualifies as looking
out for the interests of all of us.
CHAIRMAN KASS: Rebecca.
PROF. DRESSER: I think that maybe this depends on whether
our project gets extended, but if we are going to use the RAC as
a model in our conclusions/recommendations, I think that perhaps
we should get more of a case study of the RAC because it's an
It, strictly speaking, does not have the power to turn down studies.
It has the power to require a public discussion, and even that power
is only applied to studies that come from institutions that receive
federal funding for rDNA research.
But most of the privately funded studies are also submitted because
of this informal acceptance by industry that this is a good thing
for them to do. So it's a mixed voluntary/mandatory system.
The FDA is then the one that backs it up and is trying to work
more with the RAC, and they would have the power to turn things
down, and they have exercised jurisdiction over genetic modification
So it's a little more complicated, I think, and also we should
acknowledge that in the Gelsinger case the RAC made a recommendation
about that study to make it safer, at least what they thought was
safer, and it fell through the cracks. The recommendation was not
followed, and that's believed to be one reason why Jesse Gelsinger
So it's not a perfect system, and if we're going to rely
on it as a model, I think we should get some more details on it.
The second comment is I don't know if this would be acceptable
to people, but a possible supplement to a recommendation for increased
monitoring would be and distribution of the information that's
discovered perhaps on a Website. The government, NIH, now has lots
of stuff on the Website that's intended to educate patients,
prospective research subjects.
So providing a, quote, unbiased account of the information that
we have now, as well as the information that's discovered with
more monitoring would be another action that I think the federal
government could take that would possibly be less controversial.
You might get into debates about what that information should
say, but if there were a place where people could go, people who
were considering these various methods could go to get, you know,
down to earth information on what's out there, what we know
about these procedures, that would be helpful, I think.
And then finally, there is another dimension to this outcomes
research that might be more controversial. I think just studying
the health of the children, the physical health of the children
is probably not controversial, but to the extent that we might want
to recommend or discuss outcomes looking at the well-being of these
children, the psychological well-being, the attitudes the parents
have toward them, those kinds of questions, I think our last standard
and outcome studies, I mean, they are looked at that to some extent,
but that might be a difficult thing to study and a controversial
thing to study.
CHAIRMAN KASS: Jim Wilson.
PROF. WILSON: I don't want to disagree with Mary Ann's
suggestion that an improved informed consent agreement might be
preferable, but I do want to issue a cautionary remark. I go to
the doctor a lot, and even for routine exams, you're presented
with a clipboard that has ten sheets of paper on it, and you're
told before the doctor can see you, you have to read and sign all
Well, having done this often enough, I don't read any of them.
I sign them. I'm thinking of having a rubber stamp invented
so I can avoid signature bursitis.
And as I look around the room at other patients, a few stare at
them, but most simply sign them. The informed consent procedure
is drowning in its own commonness.
Now, there may be a way by designing a kind of document that says,
"Warning. If you follow this procedure the chances of the
following unfortunate outcomes rise by X percent," or above
a baseline. "On the other hand, the benefits will rise by
Now, my physicians whom I deal with about matters of some importance
go to great lengths to explain to me orally in their office what's
going on, and I depend on their advice crucially, and I appreciate
their professional skill in supplying it.
But the informed consent agreement supplies nothing. So that
before we amiably agree to an improved informed consent procedure,
we ought to take a hard look at it to see if it does any good at
CHAIRMAN KASS: Mary Ann.
PROF. GLENDON: Yeah, I think all of us who consult physicians
have had exactly this experience, and I often think as I add my
signature I'm a lawyer and I'm not reading the document.
This is what you told your students you must never do.
But I think there is an important distinction between these informed
consent forms that we have before medical procedures that we know
we've got to have anyway, whatever the risks are, and what happens
at an in vitro fertilization clinic where the person who
goes there is more like a buyer than like a patient.
It's a buyer of a service, and consumers are very interested,
Jim, in knowing — especially consumers of a very high priced
service — they are very interested in knowing what is it going
to cost, what are the chances of success, what are the risks and
the down side, and that's why I put it under the consumer protection
rubric rather than under patient's informed consent.
CHAIRMAN KASS: Frank. Frank and then Janet.
PROF. FUKUYAMA: Well, I have two separate points. Rebecca
is absolutely right. We should not take the RAC currently as a
good example or necessarily good example of self-regulation.
There was actually a 25th anniversary conference or the 25th anniversary
of the founding of the RAC where people, you know, evaluated where
they were now, and a lot of conclusions were that, in fact, the
industry had changed sufficiently such that self-regulation did
not work as well now as it did when the organization was founded.
That stands to reason. This kind of self-regulation works best
in small, homogeneous industries that are based in one country where
all of the players know each other. When they get heterogeneous,
when there are a lot of, you know, different interests, when you
get a lot of international players, this kind of thing tends to
break down, and the industry has changed a lot.
I mean, in '75 when Asilomar was first held, all of the funding
was federally funded, you know. There were scientists that all
knew each other, and they could police each other pretty well, but
the character of that industry has changed. There are a lot of
I spent some time at Johns Hopkins which has a Center for Civilian
Biodefense Studies that's headed by Tara O'Toole, previously
by D.A. Henderson, and it was interesting talking to them about
the RAC because they're worried about, you know, rogue labs
doing bioweapons research, and I asked some of the young microbiologists
there, you know, "When you do your studies do you regularly
go to the RAC?"
And they all laughed and said, "No, you know, too much paperwork,
I mean, and we're not going to do it."
Well, what about, you know, their ability to even know what's
going on in, you know, recombinant DNA that may be of concern, you
know, for national security purposes?
And they said the RAC, you know, that's not the agency that
will do this.
Can I make a completely different point?
CHAIRMAN KASS: Please.
PROF. FUKUYAMA: This is a procedural issue about how,
assuming that we've got more time to study this beyond the current,
just the next meeting. I think it's really important to get
the views of all of the major players.
I mean, we've got, you know, in the audience today representatives
of the ART industry, and I think it's really important to get,
you know, a good sense of buy-in and have people talk directly to
the Council about their views on these issues.
And I think I just want to reemphasize. I forget who at this
point made this point about how this will not come about unless
the industries and the scientific community directly affected by
this, you know, believe that this is somehow necessary.
Now, Paul mentioned, you know, the concern in Europe over GM
foods. It's a kind of odd. I wouldn't raise that as a great
precedent because I think that a lot of that, the peasants, you
know, with the torches are actually pretty irrational on that issue,
and you certainly don't want to encourage that.
But there's an important lesson for the ag-biotech industry
that comes out of that European experience, which is that Monsanto
in particular had the option of going for a limited form of labeling
when they confronted this issue in the early 1990s, and they took
the attitude, well, you know, it's going to cost us a lot of
money, and we know that the science doesn't support the lack
of safety of GM foods, and so they just plowed ahead.
Europeans then clamped all of these regulations, including labeling
requirements, and they have been closed out of European markets
as a result. I think if you talk to their executives privately
about whether they regret that decision, a lot of them will say,
"Yes. In fact, even though we think it's irrational, it
would have been better for us if we had accepted, you know, a modest
degree of regulation that we could live with."
And I think none of this is going to work unless, you know, the
affected communities come to feel that this is in their self-interest
to do so both procedurally, if you ever design an actual institution,
but I think procedurally within the Council it's extremely important
to develop this sense of buy-in from people that will have to live
with this stuff.
CHAIRMAN KASS: Thank you.
DR. ROWLEY: Well, I was just following on the comments
about informed consent, and of course, this is driven by the government
requiring that one has more and more detail for individuals to sign
so that hospitals are continually making their informed consent
much more comprehensive and, therefore, ten pages long in order
to meet the government requirements. So that is an issue.
CHAIRMAN KASS: We are close to the end of the time allotted
for this session. Let me see if I summarize the sense of what's
There have been specific suggestions both about the findings and
about the policy options papers for enlarging them, perhaps shifting
the emphasis, but the general sense is that the staff has done a
pretty good job in both summarizing and providing the array of things
to be thought about, and that the next step really would be to go
through this perhaps with some intermediate consultation from all
of you and see what kinds of concrete things we might consider by
way of recommendations at this particular stage, as well as the
things we might encourage for further reflection and study in the
next phase of such an inquiry.
Specific comments and criticisms on these documents by E-mail,
please, and we will have something for you when we next convene
on this topic, which I think will probably be at the September meeting.
PROF. WILSON: Could we also add this notion of a brief
case study of RAC, which I think if somebody could do that it would
be extremely helpful to me since I am an outsider?
CHAIRMAN KASS: A brief case study. I think it's a
major job. Am I wrong, Rebecca or Frank?
I mean to do this properly would be —
PROF. FUKUYAMA: There's a literature, though. There's
an existing literature on this. So I think you could fairly easily
review what has been written already.
PROF. DRESSER: That would be a shortcut. Just give some
articles at this point and then maybe later decide.
DR. ROWLEY: Of course, another thing one could consider,
Ted Friedmann is the Chairman of the RAC. He has already come and
spoken to us on gene therapy, but it might be possible either to
have him come or to ask him.
Now, some of you may say, "Well, he's got a vested interest.
So it's not going to be the same," but you know, he is
a pretty thoughtful individual. If he could write a paper, such
as Catherine Verfaillie or Jim Thomson did, for our next session,
that might be a helpful perspective in addition to the literature
that you're citing.
CHAIRMAN KASS: Why don't we take under advisement
some way to get some kind of material, whether from Ted or from
the existing literature at least as background if not at the meeting
so that when we next time meet we have a further sense of how that
has been working.
For a change, we finished a session on time. Am I right? Yeah.
In 15 minutes we'll reconvene at 10:15 for the next session.
(Whereupon, the foregoing matter went off the record at 10:01
a.m. and went back on the record at 10:22 a.m.)