Friday, June 13, 2003
Session 5: Biotechnology & Public
Discussion Document on the U.S. Regulatory Landscape: Part I (ART, Preimplantation Genetic Diagnosis)
CHAIRMAN KASS: All right. Good
morning. This is the fifth session of this meeting, and the first
of two sessions this morning devoted to a discussion document on
U.S. Public Policy on the Biotechnologies that Touch the Beginnings
of Human Life: A Detailed Overview, a document prepared by the
staff under the direction of Carter Snead, our General Counsel.
And first of all, I want to express on behalf
of the Council our gratitude to Carter and members of the staff
for preparing such a comprehensive and thorough document for our
I have invited Carter to join us at the table
to deal with any particular questions that might come up that he
could perhaps help with though. As I will indicate in a few minutes,
this is not the occasion for line editing or quarreling about this
or that particular fact.
But it would be a lot easier than shouting across
the room if we want to address a question to him. So, welcome indeed.
At the risk of repeating a few things that I said yesterday, because
I would like to make sure that they are part of the record of this
discussion, and where we are not simply inviting comments from our
guests, but speaking about our own work as generated internally,
I think it would be useful to remind ourselves of how we got to
this point, and what this document is and is not.
And then to set something of the goals for our
discussion of it today before we proceed. The interest in regulation
of biotechnologies is a topic that goes back to our first meeting,
when Frank observed that councils come and go, and have their discussions.
But amid all of this activity, it is very far
from clear whose business it is to actually monitor, oversee, and
offer guidance where guidance might be needed in order to safeguard
and to advance the area of human goods that are at stake here.
And we really aren't clear which institutions,
public or private, are now responsible for what sort of oversight
a regulatory activity under the name of what. I mean, some of the
institutions are clear, but it has been on our mind from the beginning.
Then as a result of the cloning report, where
we were tackling a teeny, tiny piece of the larger area of the conjunction
of reproductive technologies and the coming of possible interventions
based upon genomic knowledge, there was a recommendation that one
actually take up the subject of the regulation of biotechnologies
in this particular area, technologies that touched the beginnings
of human life.
And that the Council in fact authorized the staff
to prepare a discussion document surveying the status quo without
prejudice as to what would result for the Council as a result of
activity, that activity.
And this document is the fruit of that effort,
and its principal aim, and I am reading now from the document, "is
to provide council members with a detailed account of the institutions
and authorities that presently govern the uses and applications
of the biotechnologies and practices at the intersection of assisted
reproduction, genetics, and human embryo research."
"It explores precisely who currently provides
oversight and guidance in this context pursuant to what authority,
according to what principles and values, and to what ultimate practical
effect. Strictly diagnostic and expository in nature, it is intentionally
neutral regarding what changes, if any, might be necessary, desirable,
or feasible, if one should wish to improve upon the present arrangements."
And the document goes on to indicate that it is
that we have chosen this focus. It is not assisted reproduction,
per se, nor the human embryo, or the evolving understanding of human
But rather the unique interactions at the conjunction
of these activities, and the new possibilities that they create
for controlling and perhaps some day remaking something of the character
of human procreation and human life.
And I think that the document also makes a very
important point if it had not been noticed before, and that is that
although assisted reproductive technologies are now firmly established
within medical practice, they are unusual in medical practice because
it is the only instance in medical practice where the treatment
of a condition or a disease, depending on how you would like to
look at it, requires the coming into being of a new human being
in order to alleviate that condition.
And that therefore there is ample reason for extra
tension and extra scrutiny where new human beings are produced,
and to begin with, the document is informed by a deep concern for
the safety and the well-being of children born with the aid of
these technologies, and therefore the question of whether we are
doing all that we can do in order to safeguard their well-being.
The next thing that I would just call your attention
to, and I won't read it through carefully, but on pages 7 through
9 the document emphasizes that all regulatory institutions and practices
operate either explicitly or tacitly in order to promote or protect
one or more important human goods.
And the document, I think without developing these
goods, at least lists them, and I call everyone's attention
to the lists there on page 8, and then in the name of those goods
the various kinds of ethical concerns they might give rise to on
page 9, and these are things that have been on the minds of staff
when they have been looking at the various institutions that are
now active in this area.
And the strategy of the document as you all know
is to take five different aspects in this area; assisted reproduction,
per se; and the power to screen the possible powers to engage in
genetic alteration of embryonic life, embryo research, and commerce,
and in each case looks at the activities.
Let me suggest what I think would be reasonable
goals for this morning. I think that it would be very good to see
whether the council agrees with the identification of the various
human goods that are here identified, and if anything to indicate
which of these are most deserving of our attention.
This is an ethics council after all in the first
instance, and not a regulatory body, and what we would have to contribute
to this discussion in the first instance is a certain clarification
of the human good, and principles, and ethical norms that we care
Second, to see whether the staff or the council
shares the view of the document regarding its assessment of how
well those particular goods are being promoted and protected, and
then third, as we move toward the end of the morning, some suggestions
for further staff work on how we can advance our own efforts in
I think that is an outline, and let me just offer
a couple of caveats for the discussion. First of all, the conversation
this morning could proceed at various different levels. I mean,
we could descend to the picayune or the dissection of little remarks
in the text, or someone might decide that now is the time to offer
grand suggestions for new regulatory projects.
I think both of those things will be, I think,
appropriate for where we are now. If people have specific criticisms
or comments on the documents, by all means let's have them.
And by the way, members of the public, especially
our presenters from yesterday, are invited to submit comments on
this document as well. Second, there was a very useful distinction
offered in the discussion yesterday — well, two useful distinctions
— that I think are worth keeping in mind.
One is the distinction between efforts —
between the adequacy of the regulatory activities, touching the
practices that are now in existence, versus thoughts about how we
can anticipate decision making for things that are just around the
corner. That was a distinction made by Bill Kristol, I think, at
one point in the discussion.
And what one thinks about what might be needed
to improve the practice of assisted reproductive technologies is
not necessarily the same thing as what one might think about whether
— about how one would go about deciding whether PGD should
become a universal practice, or what one should think about the
possibilities of germline modification, when and if that became
So thinking about what we have here now as a practice,
and thinking about things that are pretty visible, and what kinds
of discussions are necessary for those.
Lastly, a delicate matter about the question of
the human embryo in our discussion, and I at least wanted to —
and so that this discussion doesn't just simply appear as the
elephant in the room that no one recognizes, nor does it appear
as a herd of elephants in the room that makes anything else impossible.
Any discussion of public policy pertaining to
biotechnologies touching the beginnings of human life will necessarily
open the question of the moral status of the developing embryo,
and it would be futile and probably wrong to pretend otherwise.
Yet, I would suggest that it would be a shame
if a debate about what we do or don't owe to the embryo, distorts,
obscures, or prevents an inquiry into a range of other important
As a council, we are divided on the embryo question,
as is the country as a whole, and nevertheless I think that we are
agreed that respect for the intrinsic worth and dignity of children
who would be born on the basis with the aid of these technologies
is an important consideration, especially in an age where genomic
knowledge will be wedded to these new technologies, and where there
are opportunities to use these just not to promote health, but to
practice enhancement, sex selection and the like.
The human goods at stake do include the good of
the human embryo, but the reality of the other human goods in play
demand that we avoid becoming bogged down in this debate.
And I think the way the staff document has proceeded
about the explicit question about the state of the embryo, while
it comes up early, has a section all to itself, primarily in the
area of embryo research, whereas the earlier questions are on assisted
reproduction, genetic screening, the possibility of genetic manipulation.
And it is that nexus of things that I think deserve
our attention. The last point on this, and then I think we should
begin. I would like as we think through today and beyond today,
some people have perhaps global ideas for what would be reasonable
to do. I suspect that on those global ideas that we might come
to blows. But it would be I think a useful strategy to try to think
about those areas in which all reasonable people might agree that
there is some kind of suggestions for improvement that could be
offered, even if they turn out to be modest, as well as thinking
through the possible longer term strategies for something larger.
So I have more to say about that, I think, after
we see how the discussion goes. But the floor is open for your
comments on whether the document has at least, to begin with, identified
the things that we are to care about, and whether it has illuminated
us, and given us illumination on how we are doing with respect to
those matters. Alfonso, please.
DR. GÓMEZ-LOBO: Proceeding
more or less in the order that you are suggesting, I am turning
to pages 8 and 9, which are the — I would say the philosophically
most relevant ones, and I have a little suggesting, which is really
a big suggestion, and it is that, in the list of human goods, that
the first one we have is the health and well-being of human subjects.
It seems to me that in fairness that we should
add at the beginning the life, because before you have health and
well-being, you have to have life. Human life is after all the
grounding good, and it is what sustains health, which sustains well-being.
And of course it should be a major concern in
any discussion of nascent and human life, and accordingly, two lines
after that, I would suggest that we refer to the children not who
may be born, but who may be generated or conceived.
In other words, I think that there is a good and
a value there even before birth. So I am just suggesting that we
pay attention to this grounding of human good.
CHAIRMAN KASS: By the way, I
think that I would like to hear from everybody on this, just to
have the reactions of everyone at some point in this discussion
with respect to the document. So if I don't hear from you,
I will call on you. Alfonso, do you want to continue?
DR. GÓMEZ-LOBO: Well,
I don't know what to gather from the silence. I hope it is
approval. I want to mention something on page 9 concerning the
ethical concerns, and this is of a different nature.
I am a little bit worried about the claim that
there are hazards of living with too much genetic knowledge. I
really don't quite understand that. I am personally of the
conviction that there is never too much knowledge.
That knowledge and truth is a human good, and
the more we know about our genetic constitution the more we know
about the development of life, and the more we know about anything
I just cannot see what it would be like to be
living with too much genetic knowledge. I would love to know more
about my own genetic constitution, and to know if I am doomed to
die in the next 3 years or whatever.
So I would be very careful about the praise of
ignorance, which would be implied in the notion that we know too
CHAIRMAN KASS: Gil, do you want
to straighten him out?
DR. ROWLEY: I might just say
parenthetically that I have underlined that particular phrase and
wondered about it myself.
CHAIRMAN KASS: Gilbert.
PROF. MEILAENDER: You may be
right, Alfonso. On the other hand, there are large arguments about
whether one would want to know that one had a late onset disease
like Huntington's, for instance. I mean, some people seem to
think that they would want to know, and other people are pretty
confident that they would rather live without knowing that.
And I am not certain that general principle about
the good of knowledge helps us conclude that one set of those people
is making sort of prudentially and practically the right decision,
and another set of people is making the wrong one.
It seems to me that it might be hard to say that
there was only one sort of decision that all human beings should
make in such circumstances.
CHAIRMAN KASS: It is not that
we are necessarily endorsing these, but these questions have been
raised and the genetic counselors often agree not to present information
for those kinds of conditions where there is at the moment no remedy,
and that there are also pregnant woman who do not want to know or
question the genetic results of amniocentesis, and they choose not
to, although one could say that there is a certain amount of pressure
placed upon them in fact to have this done.
So it is not like anybody is here arguing as a
general principle in praise of ignorance. The question is that
Hans Jonas has in fact a very nice paper where he talks about this
as a kind of scientifically-based astrology, which the foreknowledge
of the future was somehow frowned upon.
And at least it is a question, that's all.
DR. GÓMEZ-LOBO: Yes,
and I am of course aware even in myself that often times one does
not want to know. It is typical of the spouse who does not want
to know whether their spouse is cheating on him or her or not, and
things like that.
But if we are — as an Ethics Council enumerating
ethical concerns, I think we should lean in the other direction.
In other words, the fact that, say, a couple may not want to know
the sex of their child should not encourage the view that if that
knowledge can be pursued, then a council like this one should encourage
I think that there is a much broader — should
I say — value in encouraging knowledge, and leaving it to
the individual if the individual doesn't want to know.
PROF. MEILAENDER: Could I just
ask him a question? I just wasn't sure what is suitable. I
understand you to say, and I don't want us to descend forever
into the nitty-gritty of this, but that if a couple can know the
sex of their child before that child is born, you think that is
knowledge that they should definitely pursue; is that what you said?
DR. GÓMEZ-LOBO: No, what
I was suggesting is that if as say scientists if that knowledge
can be obtained, they should be obtained whether in particular cases
certain couples may not want to avail themselves of that knowledge.
CHAIRMAN KASS: Other comments?
PROF. GLENDON: Are you ready
to move to another subject concerning the material on pages 8 and
CHAIRMAN KASS: Yes. Bill, I
think you wanted to say something?
DR. MAY: I just wanted to offer
a comment. It seems to me that there are those moral problems that
cluster around the terms and conditions under which you acquire
knowledge, and then those moral issues that cluster around the application
And this simply suggests, and it doesn't argue,
to eliminate knowledge, but simply acknowledges the fact that there
are a cluster of problems that accrue for human beings in living
with knowledge, and that is all that is being affirmed it seemed
to me, and not an argument for know nothingism.
CHAIRMAN KASS: Yes. Thank you.
To this point, Jim? Jim Wilson is still on this point.
PROF. WILSON: I think my problem
with page 9 and part of page 8 comes from the fact that it is stated
in such summary form that I don't understand the meaning of
many of these propositions.
Now, obviously in a document of this sort, you
have to have a kind of overview, and at the end, a summary. So
I am not objecting to the principle involved here.
But I am concerned that stating such things as
the hazards of living with too much genetic knowledge, or the effects
of commercialization on the dignity of human procreation, or something
appears to teach the primacy of genetic causation.
These are phrases that will be differently interpreted
by people, and to some they will sound like arguments, especially
since in this section on ethical concerns, we have very few concerns
that reflect the view that some people may have that assisted reproduction
ought to be encouraged, and that more money should be spent on it.
That the Federal Government should embrace it.
This is not necessarily my view, but there are
people, and we heard some yesterday, who clearly say that they don't
want regulation. They want more money. All of these ethical concerns
by and large reflected the desire to appear to control, limit, or
possibly extinguish it.
I am not saying that this is the way the staff
wrote it. I am simply saying that by putting these things so briefly
without any explanation up front, it is going to give rise to concerns,
and perhaps there is a way to expand page 9 by adding the equivalent
of one more page, in which you state ethical concerns that argue
both for enhancing and funding assisted reproduction, and ethical
concerns that argue for restricting, modifying, or possibly eliminating
And then in a sentence or two define loosely each
proposition so that we are not left with what appeared at first
glance to be slogans.
PROF. MEILAENDER: Just a reading
of the goods on page 8. I would say that 1, 2, 3, part of 5 —
PROF. WILSON: I was talking
about page 9.
PROF. MEILAENDER: Well, there
is a summary list of the goods involved on page 8, and many of them
involve reasons why one might wish to pursue these technologies.
CHAIRMAN KASS: But let me come
to Jim's aid. It does seem to me that the ethical concerns
could also include that limitation of the pursuit of the positive
goods here as a result of undue restriction, or inadequate funding,
or the interference with the scientific research.
These are also scientific concerns, and I think
that page could be augmented to page 9.
PROF. WILSON: I was referring
to page 9, and not page 8. It seemed to me that those two issues
are somewhat different, and it was page 9 that concerned me.
CHAIRMAN KASS: That is easily
taken care of, and should be taken care of. Michael Sandel, are
you still on this issue?
PROF. SANDEL: Yes.
CHAIRMAN KASS: Okay.
PROF. SANDEL: Well, this follows
Jim's observation, which I agree with, though I think there
are two ways of dealing with it, and I think it reflects an ambivalence
that runs through the document.
On the one hand, the document wants to be neutral
and your introductory remarks suggested reasons for it being neutral
on what regulations should be enacted. And so that part of the
project makes it sensible for Jim to raise his question when he
points out that this isn't really a neutral list of ethical
concerns if we want to be neutral.
So one way to try to fix it would be to try to
have more balance, more enthusiasm for these technologies to balance
the worries about these technologies.
But another way to address that problem would
be to decide that perhaps we do want to — if not to propose
a grand regulatory structure, and that is not the purpose here,
but to have a document with a certain bent, with a certain point,
and I think the document as written does have a certain bent, a
certain point, because the gist of the diagnosis and assessment
in almost all of these areas is to suggest that there is no adequate
regulation for many of the ethical concerns.
So I am not complaining about the bent. I share
the concerns that the bent of the document gestures toward, but
I think it may be — I think that there is a confusion here
about what our purpose is. Do we really want simply to lay out
neutrally the various ethical considerations and neutrally assess,
or do we want to, short of providing a proposal for regulation,
point in a certain direction?
And I think we are going to be wrestling restlessly
today with this page by page, issue by issue, unless we decide that
we want to point in a certain direction, short of specifying the
Or whether we really do want a neutral document
that people on all sides of all of these issues could equally agree
CHAIRMAN KASS: Let me help on
that, or try to help on that. The sentence that has the word neutral
in it is on page 6, and this document is intentionally neutral regarding
what changes, if any, might be necessary, desirable, or feasible,
if one should wish to improve upon the present arrangements.
I mean, one might decide that the present arrangements
are not doing a particularly good job defending value X, and yet
conclude afterwards that the cure might be worse than the disease,
or that there isn't anything feasible that can be done other
So the neutrality of the document is with respect
to further suggestions for improvement. The document ought not
to be finally neutral. I mean, a diagnosis after all is first of
all a careful description, and then finally some kind of an assessment
of how well the current arrangement is doing in promoting certain
goods and protecting others.
And I don't think it means to be simply neutral
in that sense, and is that — there is no prior commitment
as to suggesting any particular alteration in this. The first task
before you would even think about doing that is to try and figure
out whether the current system is doing all that it should.
And you may decide that there is nothing better
to be done, but I think that this is a description moving in the
direction of a value, of an assessment, but to do that you have
to be fairly clear as to what goods are — what the goods are
that you really care about, and what are the ethical concerns.
If the list of ethical concerns is incomplete,
we should enlarge them. Michael, please.
PROF. SANDEL: An example of
the kind of thing that I mean and that runs through the whole document,
which I sympathize with, and so this is not a complaint.
CHAIRMAN KASS: I understand.
PROF. SANDEL: It is a question
about what our project is here. Take, for example, the conclusions
to each of the sections. As I read them, most of the conclusions
point to a problem, or an inefficiency in the current provision.
Take, for example, on page 71. And I am jumping
ahead, but this is a general point that even begins in the page
that Jim was identifying, the conclusion on PGD, "While currently
a small practice, PGD is a momentous development."
And then the last sentence, the conclusion, "There
are no government or non government guidelines regarding the boundary
between using PGD for producing a disease-free child and using it
for so-called enhancement purposes, or to produce siblings for children."
Well, this points in a certain direction. Here
is a momentous development, and it is of ethical concern, and we
conclude that we don't have adequate regulatory guidelines for
dealing with this momentous development.
Now, I don't dispute — I am not disputing
that, but —
CHAIRMAN KASS: The word "adequate"
isn't there. It is just reports, and there are no guidelines.
PROF. SANDEL: Well, all right.
But that is the gist. The gist of each conclusion is of that character,
and I repeat that I am not quarreling with the gist of each conclusion,
but these are conclusionary. These do point in a certain direction.
And I don't — we could either decide
that we should try to tinker with the language so that there is
no pointing in a certain direction, which would be one way of really
trying to balance this, or we could say that we want to affirm pointing
in a certain direction.
But I think unless we decide what we want this
project to be, then we are going to have — and whether it
is on page 9 or on any other — every conclusion really to
every section, we are going to have the same kind of ambivalence.
CHAIRMAN KASS: Does someone
besides me want to speak to Michael's point, because it is
an important point. Rebecca.
PROF. DRESSER: I agree with
both Michael and Jim, in that I do think we need to make a decision
about whether we want this to take a certain perspective, and I
don't have a problem with taking a perspective, but I think
we need to be very precise and direct about it so that clarifying
language — to make sure others understand what we mean by
dignity and unwanted genetic knowledge, and cohesion in genetic
Just to be very careful about what we are trying
to say and also I don't think that taking a perspective is inconsistent
with trying to be balanced and fair in saying, yes, there are tradeoff's,
and so there are these goods.
And more regulation would cost more money and
so the costs to infertile couples would go up, and so forth, and
so I just think that we should be out there and clear, rather than
— sometimes there is some indirect language that really seems
to be trying to get a point across without really saying it.
PROF. SANDEL: Could I just add
one other sentence, and this is at the end of Section One, page
58 to 59. The last sentence says, "For most ethical matters
of concern to this Council, beginning with the well-being of children,
well-developed practices of monitoring, data collection, or investigation,
are virtually nonexistent."
Well, you could say that is just reporting neutrally
a fact, or you could say it is pointing out a cause for concern.
And again it is a concern that I would endorse, but I agree with
CHAIRMAN KASS: Well, do other
people want in on this? Mary Ann.
PROF. GLENDON: Can I be in on
this and then raise the ethical concerns?
CHAIRMAN KASS: Indeed.
PROF. GLENDON: It seems to me,
Leon, that your Item Number 3 that you wanted to discuss this morning
may have to be Item Number 1, and on that I would say in terms of
further staff reporting is a report on the status quo, and a very
preliminary report, and an excellent one I might say. I found it
But my ideal or model would be something —
for further work, would be something like what we did with cloning,
and the very first day that this council met, you said that our
chief aim was to raise the level of the national conversation of
these very difficult issues.
And I think that we are now moving toward raising
the level of the national conversation about the difficult bioethical
issues, and another set of difficult issues, regulation.
Regulation is not even well understood and well
taught in law schools. So that lawyers, like most other people
when they think of regulation, they think of criminal law, and what
needs to be explored here is the whole tool box, the enormous tool
box of regulatory techniques.
There is enough learning on this subject scattered
around, and we know a lot of what seem to be good regulatory ideas
that turn out to have unanticipated side effects and that is caused
in the legal world a lot of people who were, say, enthusiasts for
regulation in the new deal mode, have started to become aware of
those unintended, unforeseen, consequences, and to be a little bit
more cautious, and to want to rely more on empirical work.
So I won't go on and on about that, but just
to say that I think — I mean, my suggestion for where further
work should go would be toward a report aimed at raising the level
of public understanding of these very difficult issues.
I think that is something that we did well on
cloning and we could do it again in this area. Now could I raise
my ethical concern?
CHAIRMAN KASS: Yes. Other people
can speak after and still continue with the other conversation,
but please, continue.
PROF. GLENDON: I would just
like us to consider adding to this series of ethical concerns something
like this. The general topic of this paper is public policy and
Public policy not only includes regulation, and
it includes certain decisions democratically arrived at about priorities.
And in a world of scarce resources, if we were talking about the
space program, there are always questions about how much of our
national resources do we want to put into very expensive technologies.
We are all in favor of curing diseases, and we
are all in favor of knowledge where knowledge is safe, but we don't
have unlimited resources. So somewhere under a broad understanding
of what ethics in this area, there has to be some consideration
of (a) what the priorities are, implicit or explicit; and (b) how
those priorities are arrived at.
These subjects that we are discussing have enormous
implications, whether you are talking about public funding, allocation
of public funding, or whether you are talking about insurance, and
who is going to bear — if something is going to be classified
as a disease, and it involves very expensive technologies, where
is the public discussion about whether we want that particular thing
to be a priority.
And to make it quite concrete, and to think about
the problem worldwide, very little is being done worldwide on primary
health care, and things like clean water, fighting infections that
take lives of children.
And we are having a discussion mainly here about
conditions or diseases that affect an affluent society, where people
are worried about things like the diseases of old age, and then
fertility. I just think that sort of thing should be on the table
under the heading of ethical concerns.
CHAIRMAN KASS: Thank you. Jim
Wilson and then Bill.
PROF. WILSON: I want to respond
once again to what Michael said, and it echoes a bit what Mary Ann
said. I think if Michael and I went through this document together
that we would find many passages where we would say this complete
absence of guidelines and regulations is deeply troubling and we
should do something about it.
That is the way much of the New Deal regulation
was created in the 1930s about the stock market. We must do something
about radio broadcasting. We must do something about civil aviation.
And what they did in many, though not all of these
cases, was in my view counterproductive. What I would most like
to see come out of our staff work in our next iteration is a call
for learning more about the important aspects of this problem.
We have now what, a million children born with
assisted reproduction worldwide; and a 170,000 or 200,000 of them
are in the United States, and we don't know much about these
And before we get concerned about the edge of
scientific development, pre-plantation genetic concerns, and creating
designer babies, and raising children to be organ donors, which
I think is impossibly unlikely.
We ought to find out where the main action is
today on the main problem, and do so in a way that gives us a sense
of the magnitude of the difficulties, and who is suffering, so that
we can put it in context.
We may say a little bit of regulation is needed
to control this, or we may say that these are acceptable risks,
or we may say that the incentive now is being supplied to clinics
that encourage artificial reproduction, assisted reproduction, are
the wrong incentives and the incentives should be changed.
I don't know what should be done, but I don't
want to see this document have a bent as Michael does towards regulation,
because I don't think we know enough about the subject to design
a good regulation.
I think we can do the most good this council can
do is say to the government and other agencies, look, something
has been created here, and where we don't know the outcomes
well enough to tell you whether we are doing a good job, a bad job,
or an intermediate job.
And until we can answer that question, we really
can't help you, and no one else ought to be able to help you
to design a regulatory system.
CHAIRMAN KASS: Bill Hurlbut.
Was this directly to Jim, Bill?
DR. HURLBUT: Well, kind of.
Let me just make a brief comment. I mean, I agree certainly with
that, but one of the problems that may need some kind of intervention
or regulation is that there have not been follow-up studies because
there is no federal funding.
And private clinics are not necessarily going
to do this, and also there aren't studies that look at the new
technologies as they unfold in a systematic way — either ethically
or fully scientifically.
I mean, there are new technologies always emerging,
and I don't mean to over-exaggerate this, but to some extent
this is an experimental edge of medicine. They are constantly changing
the medium, for example, in which the embryos are cultured, and
that amounts to maybe not a dangerous experiment, but at least in
an experiment of sorts.
Nobody regulates that, but the larger thing is
that notwithstanding the truth of what you said, I think what is
interesting and important here goes beyond that.
We are on the edge of moving this technology from
what looked first like a therapy, and overcoming a barrier, to now
extending into a realm that seems something beyond the traditional
role of medicine.
Yesterday, one of the speakers responded very
strongly in a moment where she said this is health care, and in
one of the documents there was a reference to the motivation for
ART as being a natural, noble desire.
But it seems to me that there needs then also
be some reference to natural means, and there was the problem.
We are moving this technology beyond what we might call the natural
and into an extension somehow of its significance.
If the first paradigm for assisted reproductive
technologies was a physical blockage of the fallopian tubes, and
that was then bypassed by this procedure, it soon became a physiological
blockage, and then a psychological blockage, and now it is to the
point where at least theoretically you could go as far as to say
there is a gender blockage, because I mean, this is very far out
maybe, but nonetheless in the last month it was announced that it
is possible perhaps to generate gametes from ES cells, in which
case one could argue that a completely infertile person does not
produce gametes could produce gametes of both sexes.
And you would get a wholly unnatural — it
has been called the post-reproductive era, but it just defies the
categories of the natural around which human life is organized in
both its biological integration and its psychological, spiritual
And that I think is worthy of our consideration
in anticipation of what is happening. We are on the launch pad
of this. It is not at this time to get the rocket directed in the
right way, rather than when it is already set on a trajectory.
CHAIRMAN KASS: Bill May.
DR. MAY: To return to page 6,
the word diagnostic does have a evaluative element in it, and therefore
the claim of neutrality is a little misleading here. It is strictly
diagnostic and expository in nature.
It is intentionally neutral regarding what changes
if any might be necessary, desirable, or feasible in response to
CHAIRMAN KASS: Right. You got
DR. MAY: Pardon?
CHAIRMAN KASS: You got it right.
That is exactly what it says. I mean, there is one part which is
not simply neutral, and one part which is neutral.
DR. MAY: Well, in regard to
Jim's point, we don't have enough knowledge, but we do know
that we don't know enough, and that does move in the direction
of some kind of monitoring and surveillance in the acquisition of
And I mean in a stronger sense would be —
and I think that is further than I think most would want to go,
is to say that it is intentionally neutral regarding what changes
if any might be necessary, desirable, or feasible.
In response to the inadequacies in oversight,
and regulation identified in this document, now that would acknowledge
that the diagnosis moves in a certain direction, but remains still
neutral as to what should be done in order to avoid Jim's characterization
of the tendency in the '30s to automatically assume what everyone
did might be better than what one had.
CHAIRMAN KASS: Frank.
PROF. FUKUYAMA: Well, I just
want to second Bill's point. I don't think that we should
dismiss these technologies that are around the corner, but still
in the future, as simply science fiction and beyond the scope of
what we are doing.
I mean, Bill Kristol made this point and I think
you yourself, Leon, yesterday made this point; that if all we were
interested in was the current safety and adequacy of the regulation
of IVF as it is currently practiced, we would not be holding this
It is not that interesting — I mean, it
is an important issue, and it would fall under the scope of this
council. But in itself, I don't think that is a compelling
enough issue to devote significant time to this.
There is a 800-pound guerilla lurking out there,
you know, which is driving a lot of this, which is the ability to
increasingly consciously shape the characteristics of children,
and to do it for — in some cases potentially non-therapeutic
purposes, and I think that is the single issue for me that we ought
to keep a focus on, and therefore — well, that's —
and so I think that a lot of the ethical issues, rather than a long
list of a lot of little things, I think that in a way that single
issue really summarizes for me what are the important issues that
we need to confront.
CHAIRMAN KASS: Let me respond
briefly. It seems to me that Jim's point is well taken, and
that there is at least in some areas here what one should simply
call for is further information to make sure that we understand
the dimensions of some kind of difficulty.
But one of the interesting things that comes as
a result of scrutinizing the way assisted reproduction technologies
have developed and are in fact monitored in this country, it is
very instructive to see what difficulties we might face if things
which are not just futuristic, but things which are here are handled
in the same kind of way.
And I am as you know rather skeptical about germline
modification, and designer babies. I don't think that is the
question here, but great increases in pre-implementation genetic
diagnosis, in the light of coming genomic knowledge, and there are
some people who claim that it is going to be very, very —
acquire a great deal of prominence.
And what we have seen just in the last few years
are a couple of things which move from sort of experiment into routine
clinical practice, where the only thing we now have operating are
the guidelines, the self-imposed guidelines developed by the profession,
which as we heard yesterday are simply hortatory and not enforced.
And I am thinking of a couple of things in particular.
There are less than 2,000 babies born after PGD in the world, and
that is roughly the figure, but no one has set up a longitudinal
prospective study of what happens to those children.
And at the moment no one cares to do so because
no one has an incentive to do so. Similarly, ICSI, there are all
kinds of antedotal reports on the risks of using this procedure.
And yet it is now in some clinics being used a
hundred percent of the time, partly Jim, I think, in response to
the perverse incentive that is provided by now having to post your
success rate so that people can see which clinic has the best success
rate, and you get a higher success rate with ICSI.
And there are some clinics in which every single
assisted reproduction is produced in that way, and there isn't
a study on — a formal study, and a prospective study, to see
what the implications are for the children that are born.
It is not to criticize that, but it is to see
that all kinds of new things that are coming — and the sex
control thing also — is that a decision that should be simply
left without public debate to the private choices of the people
in the fertility clinics, and their providers.
Or is that something that the larger public should
have a say in. So partly I agree with Jim that there are things
for which we don't know enough, and what we really have to do
is get more knowledge.
But there are other areas in which we see how
the pattern of decision making goes. It is not a matter of public
decision. It gets brought into medical practice, and once it is
in medical practice, you simply have to rely on professional codes
and professional pressures.
And not only I, but Dan Foster yesterday in his
questioning indicated that there were certain kinds of difficulties
as to whether the professional self-scrutiny in this area has been
adequate, especially if as when Rebecca raises the question do you
regard the unborn child as a patient of yours, and we got no answer.
And the answer is that they don't, because
as soon as a pregnancy is established, the patient goes to the obstetrician,
and the pediatrician and the parents look after it there.
So there are ways in which — and I am not
second-guessing them, and I don't mean to second-guess the way
that this has developed, but we have seen something about how things
have gone, and then the question is whether we should simply silently
accept the things that are coming on the same model, or whether
there really are things going beyond simply the treatment or alleviation
of infertility at stake here, whether some kind of at least data
gathering, monitoring, oversight, anticipatory, is warranted by
what we see.
Not 50 years from now, but this year, next year,
5 years from now. So I would like to underscore that. Janet, please.
DR. ROWLEY: Let me just make
a few comments. I am pleased that you said designer babies seem
to be highly unlikely because this is opposite to what Frank says,
with the 800 pound guerilla right around the corner.
PROF. FUKUYAMA: I was not referring
to germline. I was referring to exactly that same set of issues,
and what I said is not predicated on my belief that germline is
around the corner. I do not believe that.
DR. ROWLEY: But this germline
designer babies is certainly mentioned a number of times in this
document, and I think that certainly — who knows, 20, 30,
40 years from now, we may have enough genetic knowledge to do that,
and I think we are equipped to deal with now.
So I think that should not be an issue. You made
the statement, Leon, that there is no incentive for clinics to follow
up on babies, and what both the — what several of the people
yesterday, including Kathy Hudson, pointed out is that such follow-up
studies are extremely expensive to track down and find the parents,
and find the child, and do some kind of evaluation of the status
of the child, costs a great deal of money.
So where is that money going to come from? The
clinics do not have that money, and the government so far has not
provided such funds. Kathy was saying that her foundation was going
to be doing some of this with the CDC, which has just recently had
responsibility in this area.
So a positive thing from this committee or council
could certainly be the emphasis to move ahead, and more data are
required, and to gather that data costs money.
And that we would urge that whomever comes forward
with the money to carry out these studies so that we could proceed
on the basis of some knowledge. Along those same lines, it has
also been pointed out that all of the developments in assisted reproductive
technology are really derived from experiments in the individual
clinics, all of which are carried out on patients and potential
And there is no funding for research as to what
the effects of such immediate changes or other developments are
on the health of the potential child, as well as other things.
So that it is absolutely true, and almost unique
in medicine, that all of your experiments are carried out on living
subjects, with the outcome somewhat uncertain.
And finally I just want to comment that I think
Bill is referring to the paper in "Science" of Kay Hubner,
of developing oocytes from embryonic stem cells. Maybe you were
referring to something different.
But this was in a murine embryonic stem cell line,
and of course we know that trying to extrapolate from animal situations
to humans is fraught with a lot of danger.
CHAIRMAN KASS: You are not going
to argue about that particular point?
DR. HURLBUT: No, it is just
that — well, I mean, I agree, but one of the problems that
strikes me with ART is that so much of this technology seems to
have bypassed thorough animal model studies first.
I mean, I have very mixed feelings about this.
Yesterday when we were hearing testimony, I thought that some of
it was pretty compelling about this — about infertility being
at least a disorder, a disease.
I feel like we are in a bind here. On the one
hand, we don't want to endorse this on a Federal level because
it has got so many controversial edges. On the other hand, we are
neglecting an important realm of social need.
And I think that maybe one of our recommendations
ought to be some limited Federal assistance in studying all of this
that goes beyond what has been done up to this point.
But one of the things that should include are
good animal studies to the degree that they can simulate the human,
we should at least do something to see for example whether ISCI
has generational effects before we start bypassing the sperm competition
that is involved in fertilization, and whether the disruptive effects
of penetrating the plasma membrane and so forth have an effect.
I mean, ICSI went from a serendipitous discovery.
The reason that it wasn't known is because you can't do
ICSI with mice. And you are right on that level, but now they have
figured out ways to do it with mice, and we can do it with some
But it went from a serendipitous discovery to
clinical use in 18 months, and with virtually no in-depth studies.
And I think that strikes me as wrong. That just strikes me as medically
imprudent, if nothing else.
And we should supply a context in our civilization
where such a large need is somehow legitimately studied, at least
to the borders of the ethical issues. And we should try to use
whatever animal models can simulate the human.
CHAIRMAN KASS: Could I —
I am going to call Paul and Alfonso in just moment, but could I
suggest that — I am going to try to get us back to things
having to do with the document as a whole rather than some of the
This is not to say that the points just made are
not important and they will be duly noted in what we do further.
And Paul and Alfonso please feel free to go where you would like.
In fact, why don't I let you go first and then I will start
DR. GÓMEZ-LOBO: My suggestions
along these lines — may I, Paul? No, I just — at least
in my mind, I am becoming a little bit clearer about what we are
doing here. It seems to me that we should treat the document, in
fact, as a descriptive paper of what is out there.
And it should be criticized on that basis. Let's
say if there is a claim that that is no regulation of an activity,
and someone knows that there is, then that would be a matter of
Now, descriptive statements are always borderline
with the valid ones, but I would defend the document and say that
by and large it does satisfy the requirement of being neutral.
Now, to say that there is no governmental or non-governmental
guidelines regarding something does not imply evaluation. Someone
might say that's great, and let's leave it like that, and
someone might say, no, we should do something about it.
But that generates a second task, or a second
document, a second report, and it seems to me that we should clearly
separate the two tasks. We should once we have a feeling that this
indeed reports correctly regulations and ethical concerns, then
we should so to speak close the book and move on to address those
issues that Frank has mentioned, and everybody else has mentioned.
CHAIRMAN KASS: Thank you. Paul,
DR. MCHUGH: Yes. I also am
very pleased with this as a first draft approach, as it encounters
as we have seen here a commentary that could shape its effect, and
its ultimate expression.
But I want to come back to our beginnings, and
say that I am concerned about the document a little bit in the sense
that it raises many appropriate ethical concerns, but often not
of the context of the real feeling for the issues that have generated
It is as though here we recognize that reprogenetics
has done good for certain kinds of conditions, and it is appropriate
for them; and then it jumps quite quickly from that to, well, here
is what we are concerned about.
Not that I don't share those concerns, but
I also want to emphasize the sympathy that we should have for these
conditions. Now, there is only one reference to a condition that
I know very well, and that is Tay-Sachs disease.
Now, let me just tell you that Tay-Sachs disease
is an awful condition for a family to face. It is a condition in
which a child is born, and ultimately very soon becomes extremely
dilapidated and dies.
For a family to consider without help a subsequent
pregnancy, let me just tell you that it is more than I can ask of
them. That's all. I mean, you ought to just sit back and say,
listen, I can't ask them to go through that without some help.
And I am doing that as a doctor who has carried
a family through. Now, if there was some further expression, as
I think this board does appreciate, that this kind of suffering
will be potentially through the advances in reprogenetics that families
could be spared that.
Then we would know a little bit more what the
stakeholders have, and let's get their dukes up with us at the
beginning, and that's what I want. I want this — and
by the way, I agree with everything that has been said, especially
what Mary Ann said about how important it is for us to speak to
the American public, and have them see that we are honest brokers
But without something more, even something like
a case study or something that shows the suffering that prior to
this advance would be more than any of us would want to offer to
a family, we will lose out.
CHAIRMAN KASS: Excellent.
DR. ROWLEY: Well, following
that up, it is my impression that the incidents of Tay-Sachs in
Askernazai Jewish families has dropped remarkably with the help
of various types of genetic diagnosis.
And those are figures that are available and could
be included. So I did actually have in my notes the comment that
this is written in a sense from a very negative point of view of
only concerns and nowhere do we talk about what for individual families
how remarkable this has been.
In other families up until recently for X-link
disorders, such as muscular dystrophy, you automatically aborted
every male because this, by and large, affects mainly males.
So in families where this was segregating, they
aborted 50 percent of the males, and they aborted 50 percent that
may have been normal, but the family couldn't face the prospect
of having another affected son.
So none of the positive things are portrayed in
this document, and I guess as long as I have the floor, if you don't
mind my intervening, but I would like to suggest that — and
you may think that this is word snipping, but I think it is more
Even if you look at the table of contents, Items
1 through 4 are power to initiate human life by artificial means,
et cetera. I think what we have and what we are describing here
is the ability, the capability, the capacity, to initiate human
And I think that throughout the document that
power is used repeatedly, and that does have implications that are
not necessarily neutral, and I would certainly recommend that one
consider changing that wording, because then I think it also changes
the concept or the flavor if you will of the whole document.
CHAIRMAN KASS: Gil.
PROF. MEILAENDER: This is really
just a question. I don't have any strong feelings about it,
or at least if I have them, I am not yet aware of them. I may become
aware of them. But if one were constructing a document about regulation
of the airline industry, or something, you wouldn't start with
a long discussion of the benefits of being able to get in 4 hours
from Chicago to Portland, or give a little vignette of someone who
had been able to get out there quickly.
It would not occur to you to do it. Now maybe
our subject matter is different, and maybe I am missing something.
I do agree that there are real questions about this language of
neutrality. I mean, that question I took seriously.
But I just — before we go too far down this
road, I would at least want to think about kind of what you are
doing if you construct a document on regulation.
If we want to demonstrate that we are sensitive
folk, I guess that is a good thing. But I am just puzzled. Now,
I could be persuaded. I have no particular inclination on it, other
than it just seems to me that it was sort of a puzzling way to think
about a document on regulation.
CHAIRMAN KASS: Paul, it's
DR. MCHUGH: You're not serious,
Gil. I mean, this is not an established industry that has been
organized from its beginnings, and through which various regulatory
processes have taken form, and we have found ourselves in and out
of trouble in relationship.
This is a very new arena of human enterprise,
and in which we are concerned about both what we are doing, and
how we have achieved things, and what could go wrong. And I am
just saying everybody knows that, and I think you are teasing us.
CHAIRMAN KASS: Jim Wilson and
PROF. WILSON: The airline industry
was regulated starting in the 1930s in two ways. First, we require
a certificate of air worthiness from the Federal Aviation Administration
to make sure that airplanes don't fall out of the sky.
This has provided some good, but not a decisive
good, because airlines have a vested interest in making sure their
airplanes don't fall out of the sky, and particularly the pilots.
But it enhanced it and it provided an overview.
But at the same time the other form of regulation vested in the
Civil Aeronautics Board was to regulate prices, so that the government
would set prices, and there would not be price competition.
And the effect of this was to freeze out competition,
and to make certain that the prices were higher than most people
could afford to pay. I remember when I started flying on airlines,
and this is back in the Harding Administration I think, you would
get on an airplane and they would have a 50 percent load factor.
And you would have the undivided attention of
people who were then called stewardesses. Today the planes are
packed. Why? Because airlines set their own prices and this was
as the result of a change. We made a mistake in the 1930s with
respect to the CAB, and after a while enough people pointed this
out. So that the government decided to change it.
So that we are not talking about analyzing the
costs and benefits of flying from Chicago to Portland. We are trying
to figure out what are the issues where the government can make
a prudent intervention that would enhance well-being to a degree
that exceeds whatever costs are associated with the intervention.
And my view is that with respect to many, though
not all of these technologies, we don't yet know enough to design
an intervention whose good effects would exceed its bad effects.
CHAIRMAN KASS: Michael.
PROF. SANDEL: I would like to
go back to the general question of our purpose, and the overall
point of this, though I think running through all these comments,
Carter, has been an appreciation of what an excellent document this
And so really here we are just discussing how
it should fit with the overall layman project of the council, but
I think everyone agrees, and I also feel it is really a first-rate
Just on the airline example, if there were a public
debate swirling, as there was about whether to have the Concorde
or the SST, there would be much discussion about the environmental
worries, and about the issue of priorities.
But there would also be some statement about the
importance of getting from New York to London in 3 hours rather
than 6 hours. And that would be the closer analogy to what we are
There is a public debate swirling about these
questions. So if we want to give a balanced account, then we should
include as we would with the SST or the Concorde, the value on the
one hand of getting there in 3 hours for movie stars, celebrities,
and financiers, Gil, and against the social costs, and the questions
So we are — we are operating in the midst
of a swirling public controversy. We know that and that is no secret,
and we don't shrink from that. I would like first to go back
to the point that Mary Ann made about how our fundamental purpose
here should be to elevate the national discourse about these broad
questions as we did with cloning.
Now, I don't think that Mary Ann necessarily
meant that we have to replicate the format of the cloning report
in the sense of proposing in this document an actual policy prescription.
But I think as I understood here, short of that,
we could still lay out very explicitly the ethical concerns and
the moral arguments that worry us. And where we disagree about
those, we could be explicit about those disagreements.
But I think that is a good model, and short of
the specific policy, I don't see why we couldn't be as forthright
about the moral questions at stake, and the way that we view them
here as we were there.
Now, as for the question of neutrality, I think
— and while Alfonso made the point that we should be descriptive,
and he acknowledged that descriptions sometimes shades into a value
of the language, which is fair enough, Bill took us one step further
when he pointed to diagnosis.
Diagnosis is intermediate between description
on the one hand, and prescription of policy regulations on the other.
So I think that we could consider this to be not merely descriptive,
but also diagnostic, which explicitly acknowledges a normative point,
or weight, or gravity.
And acknowledging it should leave room for disagreements.
I think that Janet is right when she points to the use of the term
power. That is a loaded term.
Now, it is not one that I would necessarily disagree
with, but she is right that it gives the document a certain bent
to talk about powers rather than capacities or opportunities.
CHAIRMAN KASS: Power and capacity
PROF. SANDEL: Well —
CHAIRMAN KASS: The power to
do means nothing more than the capacity to do. Look it up.
PROF. SANDEL: Well, then in
that case, then why not use the word capacity, because power has
to do with — and especially when the context is regulation,
and when the context is possible legislation or the State, you are
arraying, or those who would want to regulate, are arraying the
power of the State or of the community collectively to reign in
Now, you could call them, or Janet might want
to call them opportunities, and then we might have to sort out do
we want to characterize these as opportunities, or as powers, or
But in any case, this is not to agree or to disagree
about whether the word power should be there. But it is really
simply Janet's point is the same as Jim's initial point
about the terms that are there.
And Jim was not quarreling for his part with those
terms, but he was pointing out that they do have a certain bent.
So I think that we should aim at diagnosis. We shouldn't claim
that this is merely descriptive, and merely neutral.
We don't need to say that because it is diagnosis
that therefore we are now in a position to prescribe specific regulations,
because there are as Jim says, there is a lot more work that we
would have to do to know whether on prudential grounds that such
regulations would work or be desirable, all things considered.
So to come to my last point, and it is back to
Jim, he and I may disagree about whether the document should have
a certain bent, though I think we would agree that it shouldn't
call for specific regulations. We are not in a position to do that.
But I think we agree, and I think most of the
comments around the table have supported the idea that it does have
a certain bent. Not because it is in any way dishonest or trying
furtively to kind of surreptitiously to smuggle in values where
they don't belong.
It is impossible to discuss in any interesting
way a diagnosis of the problem without having a certain bent. And
if I could just take a look at the last — the summary and
conclusion of the entire document, page 121, in the middle.
"Non-governmental oversight is aimed,"
and this is talking about the power to initiate life by artificial
means. "Non-governmental oversight is aimed fundamentally
at ensuring the satisfaction and protecting the efficacy and privacy
of the couples who seek treatment for infertility. These standards,
while extensive, are hortatory in nature. What seems to be missing
from both government and non-governmental regulation, both independently
are in the aggregate, are meaningful, enforceable standards for
the well-being of the children who come to be born with the aid
of these new powers. Moreover, there does not seem to be even oversight
activity, much less effective guidelines, that aim at concerns relating
to the enhanced control over procreation, and with their resulting
impact on the meaning of family, children, and human dignity. "
And then on page 124, the last sentence, "As
to commerce and commodification, the present system lacks a uniform
approach to questions of access, and does not include safeguards
or oversight mechanisms for deleterious effects on human dignity
that may result from the increasing commercialization of human procreation
or the buying and selling of gametes and embryos. "
Now, I agree with all of that. I sympathize with
all of that myself. But to say that this is mere description I
think doesn't do justice to the normative weight, which I would
applaud, but the normative weight that this document has.
Now, to say that and to affirm that, we should
discuss as a council whether — now maybe not everyone sympathizes
with the sentiments embodied in that kind of call. It is really
a kind of call to action. It is analogous to what Jim was saying
they did in the New Deal, where they said here is what is missing,
and here is what is not uniform, and here is what is inadequate.
There doesn't seem to be even oversight activity,
much less effective guidelines, the kind of preamble to a further
discussion about what actively speaking would be desirable, and
those are further questions as Jim says.
So I would not quarrel with any of this. I would
support it. But I think we should, if we want to support it, we
should support it under a different description of what our purpose
is, and not be embarrassed about a diagnosis that does have a certain
CHAIRMAN KASS: Frank, and then
I would like to respond.
PROF. FUKUYAMA: Well, I would
like to return our discussion to airplanes, because I think that
is actually a good way of illustrating how I think or what to think
about what we are engaged in.
And this is an area that Jim knows much more about
than I do, and so if I get this wrong, please correct me. But one
of the earliest Federal regulatory agencies was the Interstate Commerce
Commission, which was put in place to regulate basically railroads.
And when the Interstate Highway System was created
and you had an Interstate Trucking System, that function was given
to the ICC, because they thought, well, it is just moving stuff
over interstate borders.
I believe that most specialists that have looked
back at that decision believed that it was a wrong decision because
the trucking and rail industries are sufficiently different. The
economics are different and the incentives are different, and it
should have been given to a separate regulatory agency.
When airplanes were invented, they could have
given it to the ICC, too, on the grounds that airplanes simply move
things over interstate boundaries.
Fortunately, they didn't, and they created
a separate CAB and FAA to deal with that new industry. Now, in
agricultural biotechnology, they were at this inflection point in
the 1980s when the technologies were in the lab and moving out into
There was in the Reagan Administration an interagency
set of meetings to decide whether the current regulatory structure
to look at agricultural biotechnology was sufficient.
They met and they decided that — and completely
appropriate in my view — that the existing regulatory structure
was adequate. They were going to regulate on the basis not of process,
but of product, and it was felt that there was not a sufficiently
different set of technologies involved.
And that the current and the administrative capacity
of the EPA, the Agriculture Department, and the FDA, were sufficient
to handle that. And that is the regulatory structure we have used
since then, and I think that was quite right.
Where I think we are now in human biotechnology
is exactly at that point that the Reagan Administration was at in
the 1980s with regard to agricultural biotechnology, which is to
say that we see a whole bunch of technologies moving from the laboratory
into clinical practice.
We can anticipate that there is going to be a
lot more of that, and we simply have to address this question: Is
the existing regulatory structure sufficient to handle that set
Now, my belief is that it is different from agricultural
biotechnology in the sense that the only issues raised in agricultural
biotechnology were safety and efficacy.
That is what the existing regulatory structure
was designed to do, and therefore there was really no reason to
consider major institutional changes. I believe that in human biotechnology
there are normative issues, however you want to define them, that
are just quite clearly beyond the administrative capacity of our
existing regulatory institutions.
So therefore it is perfectly reasonable for us
to at this point ask ourselves whether we need to sort of rethink
that question in exactly the same way that that interagency group
did in the 1980s.
And I guess that I disagree with Jim, and that
I just don't think that you can wait until you see those technologies
move into actual practice to a greater extent, because by that time
the inaction will mean that there is simply an accepted practice
and it will be too late if you have affections to them, just as
in the case of ISCI that it will be too late to do anything about
So that is how I think I conceive of what this
exercise really ought to be.
CHAIRMAN KASS: I noticed that
we are at 10 o'clock, and we have a second session. Let me
hold my own remarks to you — well, did you do want to do it
before the break? Well, let me say what I think I have heard in
the discussion. I am not going to be able to do justice to everything,
and the gray cells are not what they used to be, and so I don't
even remember and I will have to read the transcript.
But it seems to me that — and let me start
with Mary Ann's, I think, very welcome suggestion that whatever
we do and put out in this area ought to be informed by the original
aspiration of elevating the discussion.
And that before we start talking about nuts and
bolts, or this or that, a certain kind of clarification, and here
I would say on two fronts. One is that we can't write a textbook
on regulation and all of its alternatives.
But just as in the regulatory chapter, Chapter
7 of the Cloning Report, before looking at the particular proposals,
there was a brief discussion about science and society, and those
kinds of questions.
And it does seem to me that something towards
the beginning of this with a discussion about various thoughts on
regulation, and its range, and the various things, that would be
a contribution, because it looks to some people like either you
ban it or nothing.
And that would be — we have something to
contribute there of a semi-theoretical, or modest semi-theoretical
sort up front.
Second, it was implicit in the document, and I
thought it was also explicit, and I tried to make it explicit at
the beginning of this meeting, that one of the things that we could
do for a discussion of regulation is actually not just list the
various human goods that are at stake, but actually have the various
people on the council who care about one or the other of them a
lot write a couple of pages so that those don't become simply
I mean, the human dignity is a particular vexing
one, and that I have trouble doing that in a couple of pages. But
the question of the privacy of genetic information and reproductive
practice, or certain kinds of aspects of human freedom, or questions
about equity access, or questions about the problem of genetic discrimination,
those are things which go beyond simply a concern for safety and
are in addition to endorsement of the joys of overcoming infertility,
and the relief of the sorrows and burdens of either being someone
or caring for someone whose has these disease, et cetera.
Those human goods that are stated there as placeholders
are things which could be developed in such a document descriptively
so that anybody who wants to think about regulation is actually
going to have to have before them — and perhaps in some rank
order. We don't have to take all of those on.
But some of these might matter more to us than
others. But to set the table, and if you want to think about regulation,
you have to think about it in the name of what you are paying attention
If you want to think about oversight, and never
mind regulation, and you want to know what it is that you are looking
at for what reason, and we make a contribution if we enlarge the
scope of what ought to be within the regulatory gaze.
Next, I think that people are right in suggesting
that the list of ethical concerns are on the whole worries, and
there are also worries that are attached to certain kinds of goods
at the start here.
There are worries that regulation are going to
get in the way of having the ability to experience the joy of overcoming
fertility, or of having the opportunity of not having a child with
Tay-Sachs disease, or having the ability to pursue knowledge if
it turns out that regulatory activity gets in the way of those goods.
And I think the list of those concerns could be
developed and spelled out so that they are not slogans, and that
they are filled out here. I think that would be a contribution.
And on the question of diagnosis and description, neutrality, and
the like, I do think that if we do properly the setting forth of
the human goods at stake, that a diagnosis in the sense in which
Bill meant it, namely an evaluation — and not necessarily
by the way, Michael, with a call to action. Maybe the language
PROF. SANDEL: I am just describing
what is in here now.
CHAIRMAN KASS: I don't read
the last sentence in the same way that you do. In other words,
to say that there is now nothing in this area doesn't necessarily
mean that there should be something.
But, I mean, in any case, what follows from the
diagnosis depends upon whether there is or is not an available treatment,
and whether the treatment is worth the disease, and that remains
But I do think that this document, whatever we
put out, ought to aim at some kind of modestly evaluative description
of how well the present practices address these various goods as
we are able to describe them so that other people can understand
what we are talking about. That I think would be a contribution.
DR. MAY: If I may just add one
point in response to Frank's use of the word, "too late."
One thinks of advances where regulation comes too late, and there
is two meanings to that really possible. One is because interest
becomes so entrenched, it is very difficult to do anything about
There is that sense of "too late."
But in the case of this document, when you are talking about the
well-being of the children who come to be born, there is the problem
there of lacking knowledge.
It seems to me that there is a kind of urgency
to finding out what are the longitudinal consequences of bringing
into being people, and to have that kind of knowledge, there is
a kind of diagnosis there that moves in the direction of a call
to action in the form of finding out what the consequences are.
Because for them it is too late in another sense.
Not simply because they are an entrenched interest, but because
they are human beings upon whom we may have perpetrated certain
things, and which we ought to shy back from.
CHAIRMAN KASS: Let's take
a break. If I say 10 minutes, you will take 20, and so I will say
(Whereupon, the meeting was recessed at 10:10
a.m., and resumed at 10:32 a.m.)