Friday, June 13, 2003
Session 6: Biotechnology
and Public Policy:
Discussion Document on the U.S Regulatory Landscape: Part II
CHAIRMAN KASS: Well, why don't
we get started. I think that we have got a couple of more coming,
and we can proceed. Thinking how we should most usefully spend
this second session, which will run until 11:30 when the public
session begin, let me make the following suggestions.
I think we have some very helpful and constructive
suggestions for how this document can be improved, both to make
more explicit what we are doing, and to beef up the beginnings so
that some of these larger issues are visible, and that he ethical
matters are expanded.
And I suspect I know which of you cares more about
some of those things and don't be surprised if we call upon
you to do some drafting. But it might be useful rather than to
find further areas of limitation in the document to maybe go through
section by section looking at — I mean, keeping in mind the
larger human goods and concerns that we have, to look at the summaries
or at section by section and see whether roughly the diagnosis is
somehow seems to you to be fitting.
And we repeat that a diagnosis is a kind of evaluation
as to whether certain kinds of things are or are not being addressed.
And while it might say something is missing here, it doesn't
necessarily yet call for any particular remedy, because as has been
pointed out, remedies might sometimes be either unavailing or they
might make matters worse.
I would like at least to flag one difficulty that
was commented on at the break, and Frank Fukuyama alluded to, and
Bill Hurlbut also. So much of this — part of the reason that
we spend so much time on the assisted reproductive technologies
is that it is the gateway to whatever else is added to this matter.
And we have seen how as in so many other things
that when things enter into medical practice, especially in this
country, and especially with its decentralized form of medical practice,
yes, there are medical malpractice constraints, and there are various
other sorts of constraints.
But things become sort of routine in medical practice,
and these things are left largely to a doctor's discretion.
And small, minor improvements in the technique are one thing, but
adding whole new — I won't say powers, but capacities,
to reproductive technologies will find their way into medical practice
if precedent is any guide.
And that makes it exceedingly difficult I think
for people to sort of scrutinize matters, especially if someone
doesn't somehow think in advance about what they are likely
And if these are matters to be subject to some
kind of public discussion and debate, then I think it behooves us,
as the people in charge for looking over these matters, to call
attention to what they might be.
That, in addition to the need for new information
on existing practices and the like. But what I would like to suggest
is that we simply sort of look through the conclusions part by part,
and see or using the conclusions as a kind of mnemonic for the analysis
that we have gone through, to see where people are on this.
The first conclusion to the section on the capacity
to initiate life, page 56 through 59, where the document identifies
the particular objectives of Federal oversight, the indirect oversight,
and CLIA, medical practice, and the ASRM's guidelines, and the
PROF. DRESSER: On page 58, the
first full paragraph, about in the middle, "the guidelines
provide no affirmative protection for the well being of children-to-be."
I would take issue with that. I think this whole
phrase, "well-being of children-to-be," is used a little
loosely in different places in this document. I think certainly
the guidelines, even though they are not enforce, say that the view
that ASRM takes, that if they are to publish studies, and something
goes from experimental to clinically acceptable — I mean,
that might be a very weak standard, but that is requiring some kind
of evidence of safety and efficacy.
Many of — you know, quality control, CLIA,
all those things that are trying to promote standard — a good
standard of care, and good practice in the lab, part of the motivation
there is to make sure that children are healthy, physically at least.
CHAIRMAN KASS: Right.
PROF. DRESSER: So I wouldn't
say no affirmative protection. And I think there, as well as —
and I will just bring it up later I guess, but at the very end,
I think it would be helpful to perhaps separate psychological well-being
of children from physical well-being.
Or if there are other kinds of well-being of children
that are being thought about, that it again be more precise and
specific. The other — on that page, the other point I wanted
to make was in the last paragraph.
Let's see, the fifth line up refers to the
structure of the human family, and the guidelines here, you are
referring to the pediatrics guidelines. And again there are some
other references to that concept.
I want to know more about, well, are we going
to take a position on what a good structure of a family is, and
if so, what is that. And that raises some concerns for me. I don't
think we want to be too loose about that.
CHAIRMAN KASS: Jim Wilson.
PROF. WILSON: I just wanted
to reinforce what Paul said earlier on, that in this chapter, in
addition to spelling out the ethical concerns with a paragraph or
two of explanation, we should spell out the advantages of the assisted
reproduction and use the case of Tay-Sachs disease.
There may be other cases as well that we have
to make clear from the first, that the reason that there are a million
children in the world born with this is that a large number of parents,
roughly 2 million, think it is a good idea.
And we have to explain some reasons why it simply
may not be a good idea because they have a child, but it also may
involve other reasons. And this comes back, of course, when we
talk about the power to screen and select, which is the subject
of the next chapter.
So it may be in either chapter, but I simply wanted
to reinforce his concern that it be there Let me also add that
I have failed to observe the extraordinary accomplishment of Carter
and the staff in producing this document.
I find it remarkable. I have learned something
on every page, and the fact that they did it in just a few months
suggests to me what I long believed. That most people take too
long to finish their Ph.D. theses and could do it a lot faster if
you work hard.
CHAIRMAN KASS: Thank you, Jim.
Anything else on this, on the first section, Section 1? Janet.
DR. ROWLEY: I just thought it
would be helpful, because there is an enormous amount of information
in this chapter, and it is both government and non-governmental,
et cetera, but if you could figure out a way to put it in some tabular
You obviously made your headings government and
non-government, and then I would leave it to you to figure out what
the headings would be, because you have the headings here when you
describe each one of these, but I think that is giving people an
overview, and that would be extremely helpful.
CHAIRMAN KASS: Not for today
on this chapter, but — and I think that Rebecca's point
is very well taken, that this concept of the well-being of the child
needs to be unpacked and in its various aspects discussed.
But I think in keeping with the suggestion that
while we are not at the moment advocating regulation, a new regulation
of this or that, but it might be worth highlighting which of the
things in this chapter are causes of particular concern, and from
my own reading, I am struck by the absence of knowledge of the consequences
of ICSI as something that one would want to call attention to.
The business about multiple pregnancies, prematurity,
and those kinds of things which at least ought to be studied and
addressed, and somebody ought to take responsibility for looking
into those matters, because those that have at least to do with
the health aspects of the well-being of the children-to-be, and
I think that there is more that we need to know about that.
But I think we should be looking through these
chapters for the particular things that we might want to highlight,
as well as the larger abstract and general points. Janet.
PROF. WILSON: Well, I think
in that regard that as was brought up by some of the speakers at
earlier meetings, I think the January-February meeting, much of
this is driven by the nature of the funding of our health care system.
So that if you want to have success, the way to
have success is to implant multiple embryos, and Europeans with
a different form of health are don't implants ore than two embryos.
So I think that one of the things that concerns
or that I think we have to be careful of is not to fault the clinics,
though they certainly have their share, for doing things that are
in fact almost forced upon them by the way our health care system
And so if we criticize them for doing something
which is, or to point out areas of concern, I think that where there
are obvious reasons for them to practice the way they do that are
in a sense beyond their control, we ought to acknowledge that they
are not just doing this for a frivolous reason.
And I think that we have to be very careful in
these kinds of matters.
CHAIRMAN KASS: The second chapter,
page 71 ...
PROF. WILSON: I am in the chapter,
but not right on that particular page, and I think as Paul and Jim
also noted, my own comments related to page — and particularly
page 66, there aren't — there isn't anything in this
that really does speak to the enormous benefits that have come from
some form of PGD,and so I think for balance — and this is
a point that Paul raised earlier.
And I think this is really the section in which
we should acknowledge that appropriately. And as long as I have
the microphone, in the middle of page 66, I am sure that we are
all aware, because it was a well-publicized case, of a family having
a child that served as a bone marrow transplant donor for a sister
You know, out of a hundred-thousand or so children
born with assisted reproductive technology, this is maybe one out
of a hundred-thousand. So I think that you can cite this, but also
indicate it is a rare example.
So it is certainly an example of a source of concern,
but a pretty rare example as well.
CHAIRMAN KASS: Bill Hurlbut.
DR. HURLBUT: Well, I want to
make two conflicting comments on this question of PGD. I think
we have to be a little careful not to over-exaggerate its implications.
In order to select for even a Mendelian trait, where there is, let's
say, a 1-in-2 chance that the given embryo might have the trait,
you have to have two embryos.
To select for two traits, you need to have four
embryos, and for the selection for a trait that has more than one
allele, you need to multiply that out geometrically.
The point being that although there are 10-to-15,000
Mendelian traits described thus far, and there will no doubt be
many more added, these are mostly very rare conditions and disorders,
and so forth.
I mean, there are a few things like red hair and
so forth. But not issues of great magnitude. Most of what we are
really interested in are what are called multi-trait loci, where
many genes contribute to a single phenotypic trait.
And therefore because of the number of genes involved,
it is not going to be possible given our current state of production
of embryos, to have enough embryos to sort through to get much effect
on the traits.
I think that is an extremely important thing to
realize. That to date there have been — Mark Hughes told
me I think 6,000 efforts to do a PGD, and somewhere between 1-and-2,000
children born from this I think is the figure.
I don't think that this is going to be a widespread
phenomena. There will be a lot of PGD for chromosomal problems
with FISH and so forth. So that is true. Now that is the one side.
But I — and I know that this sounds very
futuristic, but let's at least think forward into the possibilities
here. There are several possible scenarios that might emerge if
this technology advances the way it seems to be going.
If we could develop a source of abundant oocytes,
then — and which is really being worked on for a variety of
reasons, including the desire to do cloning for biomedical research
so we don't have to harvest them 12 to 15 at a time through
superovulation, if we could induce fetal oocytes to maturation,
or perhaps use ES cells to generate oocytes, and there is a variety
of other possibilities.
There is ovarian biopsy that has been done in
mice to greatly multiply the number of oocytes. If this could be
done, suppose you could produce an abundance of oocytes.
Then theoretically you could for any given desired
progeny fertilize a hundred, or a thousand occytes, and produce
maybe — I wouldn't be surprised if you could produce an
automated PGD system.
And then you really could shift through embryos
and it could turn out that large traits, multi-trait loci converging
into large and significant traits related to things like personably
profiles and appearance, and so forth, the things that we really
would want to select for, they might turn out to be transmitted
in blocks, cassettes of genes.
And with the HAPMAP (phonetic) for example, we
are going to learn more about how blocks are transmitted. It turns
out that when there is a reshuffling of genes in recombination that
takes place during meiosis that it is not a big reshuffling like
a deck of cards.
A given chromosome only recombines one or two
times, and there are principles along which it does, and they only
recombine in specific places on the genome as a general rule.
This means that gene blocks are sorted and resorted
together. We could develop technologies where we could follow the
gene blocks from the mother or the father, and preferentially select
embryos based on a set of those and where they came from.
So I think on the one hand we should not over-exaggerate
it in the short run. In the longer run, I think we should be very
aware of it. This could be quite a transforming technology, in
terms of how reproduction is greeted.
And, well, maybe that suffices. I don't know
if that is a helpful comment, but it does point to the fact that
this technology is moving us increasingly away from what we think
of as the natural way of reproduction.
CHAIRMAN KASS: Jim.
PROF. WILSON: This may be the
chapter in which we want to mention what you and I have discussed
privately on other occasions, which is the changing sex ratios that
can be identified in the population, and the effect of sex selection
as a way of increasing the sex ratio.
That is to say producing many more male children
than female children. I do not see whether that has any policy
significance, because let us assume that Chinese-American families
prefer male children.
And let's assume that they go for sex selection.
And let's assume they get many more male children than others,
and they develop a sex ratio of 130 or 140 to 100.
This has important social consequences, but I
don't quite see how the government can do anything about it,
because if the government were to regulate in this area, has to
do it on a case-by-case basis. And you can't say, well, we
are not going to allow certain ethnic groups to practice sex selection.
But I think the facts are sufficiently important
that noticing them here, that there are these large consequences
of sex selection, might be informative to people.
I guess getting the information out is all that
I am interested in. I don't have any policy purposes, but it
may be worth mentioning.
CHAIRMAN KASS: Paul.
DR. MCHUGH: I think this is
a good chapter, and it is very interesting. Again, I am learning
a lot in this process. Again, I think it is important to represent
the new discovery also from its benefits, and I have mentioned one
of the benefits.
Of course, a benefit that is not mentioned here
is the benefit of avoiding an abortion, and the experience of a
pregnancy that is still uncommitted, and that is a terrible experience
for a woman.
And I have not made up my mind completely about
PGD, but one of the things that would spare them is this kind of
later life experience, particularly people with Tay-Sachs and things
of that sort and that experience. I think it should be mentioned.
CHAIRMAN KASS: Speaking for
myself, I guess I understand and see PGD really as an extension
of prenatal diagnosis, with some of the advantages that Paul has
just alluded to, especially if one is dealing with these devastating
But there are significant differences between
weeding out and selecting in, and one sort of — and not exactly
trivial, but generally not noticed difference is that in order to
make sure that you have got an embryo that passes muster, that embryo
has to be subjected to testing.
And if there is some risk in this blastomere biopsy
about which we don't know yet know enough, that in order to
make sure that you get a healthier child, you subject that healthy
child to risks that he would not have faced had he wound up in utero,
and you would have been able to make the diagnosis through pre-natal
diagnosis later on, though there would be the problem of abortion.
So I think it is terribly important before this
gets from 2,000 children to 50,999 or a hundred, that someone begin
to pay attention to prospectively to what the consequences are just
with the technique of finding out.
Some of my friends tell me, look, this is just
like embryo splitting, where you could get twins, and an embryo
falls apart in the two, and it is not a big deal.
But I am not so sure, and that happens spontaneously,
and this happens by manipulation, and I would like to be reassured
before I saw this become a monumental practice, whatever scale it
reaches on its own.
Also, I guess though I understand the reasons
for private choice of sex selection, I don't think I am quite
happy allowing that to be decided, and I would not be happy to allow
enhancement uses of selection.
Now, to be simply deciding on the consumer laissez-faire
model, unless society has had some kind of discussion of it, and
decided that that is the least bad way to do this, because governmental
interference, et cetera, et cetera, would be regarded or would in
fact be too much of an intrusion.
But it seems to me that a community could say,
and other communities have said, and in fact I think the American
Medical Association has declared, that the use of this, to engage
in sex selection, save for the disease related cases, that should
And it seems to me not out of the question that
this could be a matter of public policy, but I think in the first
instance that I would agree with Jim. I would like to be sure that
somebody is paying attention to what is being done in this area,
and not just in ethics groups, but in lots of places.
We ought to know about this, and we ought to know
whether it is rising, and I myself would not mind seeing a debate
as to whether this is something that society wants to go ahead with
And similarly on the question of the uses of PGD
or other genetic capacities, to go beyond the prevention of these
severe diseases. I mean, these are not things that I myself think
should simply be decided accidentally and with nobody paying attention.
And we find out 20 years from now that it is now
part of routine medical practice, and it is in that limited sense
too late. So I regard the present situation as unsettling, and
what to do about it I think requires a lot more discussion if there
is anything to be done about it.
But I find this chapter persuasive in this presentation,
though I think the balance that people have called for is absolutely
necessary if it is to be a proper document. Janet.
DR. ROWLEY: Of course, one could
take the contrarian point of view, that if you really had major
distortions of the sex ratio in a place like India, that the status
of women might change dramatically, and that in fact you would have
men paying women's families dowries rather than the reverse,
and that might be or actually have some benefit.
CHAIRMAN KASS: Hear, hear.
Frank, did you want anything on this — on the chapter on the
capacity to modify traits, and actually concludes that none of this
is on the intermediate horizon, and that in fact — this is
a quiet area, because nobody is going this, and in any case, the
RAC and the FDA have more or less stood in the wy of things going
past this for now.
And this seems to be a topic, at least according
to the document, that is worth our discussing only to set to the
side at least for the time being. Is that a fair assessment? Bill.
DR. HURLBUT: I think something
is missing in the document refers to the qualities in the procedure
and in the media that influences outcomes that are not DNA genetics,
but in a sense they are cytoplasmic factors in genetics after all.
Gene expression and so forth.
It is well known that the medium affects the outcome,
and so we should include something about that. I want to actually
make a comment to your previous comment. One of the interesting
things about this whole realm is not just the way PGD might alter
and even introduce its own form of distortion or pathology.
But from the very, very most foundational and
accepted practices, ART introduces that subtle question of how much
risk and how much disruption of normal procreation is acceptable.
And as I reflected on the question of Federal
regulation, and if we would recommend any, I kept coming back to
the question of how do you balance out individual rights to procreation
against dangers implicit in a technological, technologically assisted
And that is a really difficult and subtle question,
because if this were a drug or a device that had a 50 percent chance
of causing a problem, we would not accept it — for example,
a major congenital malformation, but we will accept it, for example,
if a person with ectodactyli, where you have a deformity of the
hands and feet.
If you have a 50 percent chance of that, we do
not interfere with the person procreating a autosomal dominant trait.
And it strikes me that from the very beginning that it is well known
that ART results in different cleavage rates than the natural.
The embryo at every stage has fewer cells than
the natural, and it is known that it produces babies statistically
anyway with lower birth weight, plus the morbidity and mortality
of multiple tasks.
We are looking at a technology here that does
have its downsides from its most conventional use, and not just
from its most extended use. And that raises a strange question
of the natural versus the unnatural, and how much morbidity and
mortality we are going to introduce technologically.
And whether or not there is a difference between
what you might call natural pathology, and artificially created
pathology, and who has a right to decide.
I think those are the kind of issues that we need
to contend with here, in-part.
CHAIRMAN KASS: Gil, a comment
PROF. MEILAENDER: This is not
precisely on what Bill had to say, but just about the chapter.
And I actually think that there is something important about this
chapter, and as opposed to just saying or concluding that there
is not much.
And I think it has to do though with what we think
this document ought to try to accomplish. The fact of the matter
is that this is the one chapter that defines that there is quite
a bit of regulation in place right now with respect to things that
are happening, and there is a reason for that.
It is because the things that are talked about
in this chapter fall under the rubric of research, or experimentation.
And in the not-that-distant pass, some very bad things happened
in the realm of experimentation.
And indeed one of the chief energizing concerns
in the rise of the bioethics movement had to do precisely with experimentation.
So that there is kind of a lesson to be learned from this chapter.
Namely, that some very bad things can in fact happen.
And that that is why when you look at this chapter,
you find that we are out of sync with the rest of the paper, and
lo and behold, there is a lot in place. Well, there is a lot in
place for a reason, and I just think that we need to call that to
CHAIRMAN KASS: Jim Wilson.
PROF. WILSON: On page 76 of
this chapter, under the subhead of "Enhanced Control Over Children,"
there is some language here which I think is premature. It says,
"A child who is created to certain specifications is"
— and not maybe — "but is more of an artifact than
a child who is merely selected for his or her existing characteristics."
In this way, genetic modification can convert
"procreation to manufacture." Well, that is an conceivable
hypothesis, but a child that is born to a woman after 9 months of
pregnancy, whatever efforts were made to modify the traits in advance,
is going to be regarded by the mother and I hope the father as a
child, and not as an artifact.
And not as something that was manufactured. So
that if you want to raise this as a tentative possibility, that
is well and good, and we will have to find out whether that happens
should this process ever become elaborated.
But I think it is premature to say with such
confidence that we are going to manufacture children or turn them
into artifacts simply because there will be enhanced control over
the genetic material at the moment of implantation.
CHAIRMAN KASS: To this point?
PROF. GEORGE: Leon, it might
be dealing with a problem like the one that Jim has put his finger
on here, that it is important to distinguish — and it could
be relatively easily done, two distinct senses in which the problem
of treating procreation as a form of manufacture could be addressed.
One would be the psychological question, and how
will children be treated by parents and others when they are brought
into being under these terms. The other would be the philosophical
analysis of the attitudes that are embodied in the decision to proceed
in this way.
Now, that would be much more subject to dispute,
but there are competing points of view about this, and there is
actually a literature about it. And there would not be any reason
in principle why both issues couldn't be raised, the philosophical
one and the psychological one.
The psychological one can be treated as a matter
of hypothesis, subject to verification or falsification. The other
has to be treated in a more philosophical mode.
CHAIRMAN KASS: Okay. Actually,
I would like before we move to the chapter on research just to add
one other thing that is worth underlining, although it is not —
it is backward looking in the second section, and that has to do
with some of the implications to screen and select for the attitudes
towards the abnormals who escape detection.
It is a problem that we — it has been around
for a long time, since the beginning of prenatal diagnosis, and
I think almost everybody has either known or had the experience,
or heard of the experience of women who give birth to, let's
say, children with Down's syndrome or something like that.
And then they face the question why didn't
you have an amnio. And we are — we have not really seen the
full scope of the kinds of distinctions now increasingly to be possible
in the light of the vastly increased numbers from which we can screen.
And I think on the question of discrimination,
not just in employment and those sorts of things where we have leverage,
but just in terms of the general attitude.
The more and more we take screening even for health
reasons for granted, the more and more one is inclined to say that
there are — and although no one would call it that, that there
are inferiors amongst us who, if only the testing had been better,
would not be allowed to be here.
And I don't know that this is a matter for
regulation either. But the question of the equal dignity of human
persons, regardless of their genetic limitations and disease limitations
as I think a value of considerable importance to be upheld and at
least put on the table, though again it is not clear to me what
follows from that.
But I don't think that many people are paying
attention to this aspect of what it means actually to go to go forward
in the pursuit of these very serious diseases with increased powers
And I like the fact that the document deals with
that, and I would like to underscore it. Paul.
DR. MCHUGH: If I could just
amplify that for you, and increase the concern, and namely that
there are screening methods now that have such large false-positives
that that — and particularly the triple testing for potential
Down's syndrome and therefore encouraging people to have amniocentesis,
that doctors are now shocked with the burden that all pregnancies
put on women, particularly when this triple test comes up positive,
even — and by the way.
Even when they go and have an amniocentesis, such
women, until their baby appears, a normal baby, is in a state of
distress about how that test went so wrong, and how that test indicated
to them that maybe there is something wrong with their children.
And so part of the problem of our present work
— you know, in France, they insist that
everybody has these triple tests, and I can vouch for the psychological
burden that many women with perfectly normal babies have after they
have gotten this result, and hear from genetic counselors that they
have the classical sign for Down's syndrome when they are carrying
a perfectly normal baby.
And the odds — the only thing that has happened
is their odds have changed from let's say 1-in-600 of having
a Down's syndrome child, to having 1-in-300, or 1-in-200.
And that is so alarming to women that it carries
on from pregnancy to pregnancy, and it is a real burden.
CHAIRMAN KASS: Let's turn
to the research section of this. In effect, silence. Here —
let me just underscore what I thought was a very interesting and
rich exchange in the second panel yesterday, when Michael Sandel
put questions to Richard Doerflinger on the subject of whether one
could consider regulatory activities in an area where one had grave
doubts about its propriety in the first place.
And up until this point it seemed or has always
seemed to me that this is one of these all or nothing propositions,
where you either buy a big package like the British or the Canadian
model, or you do nothing at all.
But it does seem to me that if I understood Richard
Doerflinger's remarks that maybe we ourselves ought to be at
least more flexible in our thinking as we think about this area
And even if this council couldn't reach an
agreement on the whole matter here, there might be some things hat
are worth calling attention to in the absence of something more
I think that wa a rather liberating comment for
our consideration, and I don't know what the rest of you think
about that, but I thought that was really one of the golden moments
of yesterday's meeting. Is that all right, Robby?
PROF. GEORGE: Yes. Yes, I agree
DR. ROWLEY: Could I raise a
question about some of the concepts on page 88 and 89? At the bottom,
it is under the heading, "Ethics." And I think where
we talk about the destruction of nascent human life.
Non-therapeutic embryo research necessarily involves
the use and destruction of nascent human life. This of course if
an area that we have discussed several times; that the likelihood
that a particular embryo will actually lead to a successful pregnancy
is less than 50 percent.
And I think that there are many people who figure
that it is in the neighborhood of 20 to 30 percent that a particular
embryo will in fact lead to nascent human life.
So I think to equate every embryo with a living
fetus and child is probably biologically incorrect, and I think
that might be considered. And then on page 89, there is regarding
and treating nascent human life as a mere means, and it goes on
to point that it coarsen sensibility, and lead to a devaluation
This is sort of the slippery slope argument that
I thought was quite effectively discredited by Jim Wilson a number
of meetings ago, and I think that maybe some of that language might
CHAIRMAN KASS: Any response
to this? Gil.
PROF. MEILAENDER: This raises
again for me just he question of what we hope to accomplish in this
paper, and I thought at the outset that it was simply to chronicle
what the current status of regulation is, and I myself still think
that it should do that in a rather modest sort of way, with maybe
less conclusion in fact rather than more.
But it is just a note that obviously if we left
this discussion, but altered the language in the direction that
Janet would prefer, then I will ask to have it changed the next
So we are going to have to find a way to deal
with the regulation question that does not require us to wage those
arguments again. Or we are going to have to kind of recast our
thought about what we are doing.
CHAIRMAN KASS: And let me say
— I mean, maybe the language can be moved slightly one way
or the other, but I think — and here I thought the exchange
between I guess Gil and Maxine Singer yesterday was illuminating.
However people come out on the question of whether
such research is licit or not, I think most people recognize that
this really is a moral issue, and the report by the Embryo Research
Panel at the NIH, and even the National Academy's own document
talks about how the early embryo is deserving of some special respect.
And that means that even if you are going to use
it and destroy it, you somehow treat it as something other than
mere tissue. And I don't see any way around, apart from sort
of defining this problem out of existence, to say that there really
is a moral concern here on how much weight to give it, and whether
this is one of these matters of principle or whether it is one of
these matters of balancing and people disagree about that.
But if this weren't a moral issue, life would
be very simple. Jim.
PROF. WILSON: I think that dealing
with human life, even basic human life, whatever the probabilities
that it will become, an implanted embryo is a moral issue. I have
no doubt about that. I have a difference between me and some members
of the council as to how far we go in protecting it.
Could we leave it with that sentence intact and
simply delete the sentence that says, "It could coarsen sensibilities
and lead to a devaluation of life in other contexts."
Which to me is a hypothesis which I find implausible,
and some people may be believe it, but it does not detract from
the fact that it is a moral issue. It is that last sentence that
I think strikes me as bad social science.
CHAIRMAN KASS: Bill, to this
or to somewhere else?
DR. HURLBUT: In line with this.
This introduces a very complex question, but if we say — even
if we take the most stringent definition of the dignity of human
life as being the organism in process, and take it all the way back
to the zygote, it then raises a second question of is there a sense
in which some studies could be done on disordered forms of fertilization.
For example, only three kinds of aneuploidy involving
trisomies are compatible with human life. And I raise this because
I now that this is a discussion that is going on in the scientific
community, where the question has been raised is if you detect an
aneuploidy with PGD, can you then use the embryo, which could never
go on to form a full human person, or not even very far in th trajectory
of embryologic development, but can you then use it to study some
measure of normal process.
And I don't want to sound too contentious,
but I think this council would do well at this stage in the development
of the science of developmental biology to try to define more clearly
what the moral boundary is here of what it would be moral to experiment
on and what it wouldn't be by the most stringent criteria.
If we could do that, we would put up a fence that
the scientists could play, too, instead of being afraid to even
get close to it, and that would open up possibilities in science.
On the other hand, I am not trying to introduce
horror scenarios, where you take someone who is almost a human,
and manipulate it. It is just that fertilization and some of the
early cell dynamics could be studied in the absence of a reasonable
CHAIRMAN KASS: Bill May.
DR. MAY: I hesitate to revisit
what we discussed at greater length earlier, but I think Michael
and Jim Wilson, and I, at the point of earlier decisions, associated
myself with their view with regard to the special respect due the
embryo. It doesn't have the kind of claim that would thwart
research that could deal with disease.
On the other hand, it isn't nothing and I
think that Jim used the phrase intermediate status, or somebody
did. And in my brief note on an earlier document suggested that
if it has that kind of status, it isn't simply a resource at
It is in a sense a human source and not simply
a resource at our total disposition. And though its intermediate
status might allow for the conduct of research, it has implications
regulating and curbing that research, and the sole illustration
given of that at the end of this document is about should not be
cultivated beyond 14 days development.
The point that I made in my brief addition to
the original document is if you understand it to be not just a fingernail
and so forth, but a kind of intermediate status, it has implications
for regulation, not simply on the terms and conditions under which
you conduct the research, but the ultimate distribution of the fruits
of that research.
Not just the generation of the good, but the distribution
of that good. If we remove from life the pre-implanted embryo and
conduct that research on it, we have not removed it from the circle
of human indebtedness.
And the form of that indebtedness includes not
simply the limits on the conduct of the research, but honoring that
indebtedness to make sure that it reaches all in need, and I think
here maybe all that would need to be indicated is that the professional
societies agree to the notion that it should not be cultivated beyond
14 days development and so forth.
But so far we have tended to be silent on the
question of the outcomes in the uses of that research, instead of
it simply being captured by venture capitalists.
CHAIRMAN KASS: Alfonso, please
DR. GÓMEZ-LOBO: Okay.
I am afraid that we are back to a very central topic, the status
of the embryo actually, although there is a sense of what you wanted
CHAIRMAN KASS: This is where
it belongs. I mean, this is where he is.
DR. GÓMEZ-LOBO: Well,
I would like to make the following remarks. The questions of probability
usually have very little or no bearing on moral questions.
For instance, the probability of a child in a
certain country in Africa to reach adulthood is 50 percent. That
does not affect in the least the respect that we owe to that child.
So probabilities, nature, probabilities a lot of times have to do
with external conditions.
Sometimes, for instance, the impossibility of
an individual reaching adulthood have to do with the facts that
there is insufficient food provided in that country.
Now, with regard to the early embryo, there is
of course two questions of probability. One is the question of
whether a certain organism, if we may call it so, generated is viable
or not, and gets eliminated.
And of course we have heard over and over again
that a very large percentage gets eliminated. But the embryo that
does not get eliminated, and that is biologically viable, does constitute
an organism which is co-extensive with what we, each of us, was.
I mean, we all started off if we are not twins
as one embryo. So there is a question of probability and the uncertainty
of determining what is what at that early stage, and which has no
more bearing it seems to me on the ones that do.
And then there is the probability of that viable
embryo of surviving, and this may also be due to external conditions.
Of course, if an in vitro embryo is not implanted, it is not going
So the probabilities would be close to nil. But
the real consideration from a moral point of view is what kind of
a being do we have there. What is the nature of an embryo in the
early stages, and it is from that nature that we are going to derive
our inferences with regard to how it should be treated it seems
So I would certainly keep the expression of nascent
human life, because it seems to me that we are worried about those
embryos are viable, and that may be subject to destruction in research.
CHAIRMAN KASS: I am slightly
mischievously moved to ask a question, and then I think we have
time for the public session. But just briefly, given your moral
views of this matter, if someone were to suggest at the present
time that there seems to be — there is disagreement about
lots of things, but there seems to be an agreement even in the scientific
community — and this was an exchange between Robby George
and Michael Werner yesterday about boundaries, right?
If there was an agreement today which said human
embryo research may not be conducted past, let's say, 10 days,
or 14 days, or what have you. Would you regard assent to such a
rule of practice, or even a law — and this is a hypothetical,
but would you regard assent to that to being complicit in the practice,
or would you regard that as a useful boundary while the debate about
other things should go forward?
Now, this is sort of the test on whether there
is some kind of room for maneuver on setting some kinds of guidelines
for embryo research. Is that in effect to endorse it?
We are not talking about Federal funding now.
We are simply saying —
DR. GÓMEZ-LOBO: I have
consulted my own conscience quite a number of times on this, and
it seems to me irrational, that is, inconsistent, to hold that human
dignity is co-extensive with human life.
And then proceed to say, well, there is a fragment
in time in that human life when dignity does not hold, which is
what I would be required to say. Now, I was a couple of weeks ago
in Berlin at a conference, and I heard Professor Jean-Claude Renard
and a professor that he was going to talk with, Rudolph Jaenisch,
say quite clearly, well, a human life starts at fertilization.
So I would have my deep in my conscience, I would
have to insist that we not experiment with live human embryos even
before 14 days.
CHAIRMAN KASS: Gil.
PROF. MEILAENDER: Just a slightly
different comment, but still directed to your query, and simply
to say that I interpreted the exchange between Robby George and
Michael — whatever his name was —
CHAIRMAN KASS: Werner.
PROF. MEILAENDER: Werner —
somewhat differently yesterday. I interpreted it to mean that if
one held Alfonso's view that one would be fool hardy to suppose
that the 14 days was anything other than a moving line, depending
on what was possible.
So in addition to the question about complicity,
there is a question about —
CHAIRMAN KASS: About prudence.
PROF. MEILAENDER: Yes.
CHAIRMAN KASS: Right. All right.
Frank, a last comment on this, and then we will have a public session,
please. I guess Rebecca wants to say something, too.
PROF. FUKUYAMA: Are we going
to get a chance to talk about the future work program and where
we go from here?
CHAIRMAN KASS: I would like
to do that.
PROF. FUKUYAMA: Then I will
CHAIRMAN KASS: Then let's
take a few minutes on it. Rebecca, do you want a quick comment
PROF. DRESSER: I will hold off.
CHAIRMAN KASS: Let me see if
I can — I think that something of the summary offered at the
end of the first session has been supplemented by more specific
comments, section by section.
There are — I am not sure that I can get
complete agreement as to whether mere description without even evaluation
is more to be preferred, or a full diagnosis with comment is more
to be preferred.
I think I hear more for the latter, though Gil
has a certain reservation. It does seem to me that short of fixing
the document and making some suggestions on how to improve it in
detail, I think what we need is first of all a clear articulation
of the particular goods that are at stake here and more fully described.
The balance matter is already addressed, and to
be taken care of. I think a search for particular areas of concern
in existing practice that deserves special notice or attention,
and attention to things which are — if not — things
which are coming in, where one wants to get prospective information
or areas where we would request additional knowledge and oversight,
and monitoring, just to flag those places.
But from the point of view of taking things further,
it seems to me that maybe some kind of general discussion of the
strengths and weaknesses of various alternatives to go beyond where
we are, and arguments for and arguments against, might be in order.
But maybe we are not ready for such further staff
work. What do people think? Frank.
PROF. FUKUYAMA: Well, in terms
of what we do going forward, first of all, it depends a little bit
on whether the mandate of this council gets extended. You know,
if we sunset this year, then I think this is a nice document, but
there is no point in doing this, because this is really a big amount
of work that we are embarking in.
Assuming that we do in some way get extended,
I think that what the staff needs to do is to supplement this excellent
beginning with the outlining of several different options, beginning
with do nothing, and going to various alternative institutional
forms that may draw on some other national models — the Canadian
or British ones that we have heard about already in this council
— simply as a further point of discussion.
Because I think that without something concrete,
where the options are laid out fairly precisely, it is going to
be a fairly shapeless discussion, and I think the staff is in a
good position to do something like that.
But I do want to make a general caution about
our proceeding — you know, if we take a route like this down
this road, because there is going to be I think intense suspicion
from many, many quarters about what we are up to, and I think that
will be quite reasonable.
Some of it was laid out in the document already,
and a lot of it really does have to do with abortion politics, because
for example, the various suggestion that you might want to look
at the regulation of the ART industry, well, that immediately raise
a red flag with many people as I think was indicated by the testimony
yesterday that, well, this is a bunch of pro life people that want
to protect embryos, and that is the basic motive for sticking the
camel's nose under this particular tent.
Conversely, it is also possible if you take the
pro life position that you can see this whole regulatory exercise
as a means of facilitating further change in stem cell, embryo research
as is the case with the HFEA in Britain, where actually the existence
of that regulatory body does facilitate research in this area.
And again this has been a concern that has been
raised by Alfonso, among others, about our proceeding down this
road. And I don't see any way of allaying these fears other
than by proceeding with complete transparency.
And transparency doesn't mean just hortatory
saying, well, we don't have a secret agenda here. I think that
procedurally it has got to be implemented in a certain way.
Now, there is a negative model, and there is a
couple of negative models, and I would say Jimmy Carter's energy
proposals, and in the wake of a second oil crisis, and the kind
of Hillary Clinton approach to health care reform in the first Clinton
Administration are good negative models of what we don't want
Which is to say that to regard this exercise as
a kind of technocratic bunch of experts on regulation coming together
and writing the optimal public policy outcome in camera, and then
unveiling it at a certain moment and saying, well, look. This is
what we experts think.
And I think that procedurally what you have got
to do is create a process by which all the stakeholders get to say
their peace about this, and that involves much more than the two
panels we had yesterday. I think this has to be an ongoing process.
If you look at both the Warnock Commission and
Patricia Baird's commission that preceded the Canadian initiative,
this was actually a very ambitious undertaking.
It was a multi-year effort, where they had focus
groups, town hall meetings, public testimony from a lot of different
people. Now, we obviously don't have the budget or the mandate
to engage in that kind of an exercise, but I think that the more
of that kind of thing that we do the better, because that I think
is the only guarantee that people will have that we are not about
to foist something on people that doesn't reflect full discussion.
And for my part, I quite honestly don't know
what the answer to the — I mean, I think Carter has raised
in this document some excellent points about the weaknesses of the
But I am genuinely agnostic whether there is a
way of moving beyond the current system to do some results which
will actually be better. That is an open question.
And so that is my suggestion for proceeding; that
the staff be instructed now to fix the issues that were raised in
the discussion today, and in this document, but to actually start
the process of drafting an options paper that will serve as a basis
for discussion later on, again dependent on the extension of the
mandate of this council.
And that we furthermore work on a kind of a procedural
set of guidelines for how we bring in outsiders to help us think
through this set of issues.
CHAIRMAN KASS: A comment to
that? Gil Meilaender.
PROF. MEILAENDER: Let me just
say a little bit about to amplify perhaps my too cryptic comment
earlier about what I thought the document was about, and this in
part really agrees with some of what Frank said, though he has got
a more kind of ambitious program at work, too.
As I think about the document and our discussion
of it, the list of goods at stake was actually it seemed to me rather
complete, and I didn't hear anybody question the list of goods.
I am not persuaded that they need some kind of
great amplification in fact. Where we continually run into problems
is on the ethical concerns discussion. If I were doing it, and
I would have to think more about exactly how to do it, but I would
get rid of the discussion of ethical concerns.
And the note of conclusions in which we are constantly
jockeying over the language to see if it is formulate in a way that
tilts one direction rather than another.
I would outline the regulatory system, and whatever
is in place in these various areas, and then at the end I would
discuss as straightforwardedly as possible — and I think straightforwardness
is essential — the various possible kinds of responses that
one might make to that.
We would have to see then whether any consensus
of opinion goes behind any of those, and I don't know whether
it would or not. There might be opinion behind to gather more information,
But it just seems to me that if in the main body
of it we got rid of the stuff that has us constantly jockeying over
buried normative possibilities, and just let those come out in the
different kinds of options one might recommend in the face of what
the review of the current system had shown, we might have something
that was straightforward, and that was clear and useful, and that
everyone could endorse.
CHAIRMAN KASS: Rebecca.
PROF. DRESSER: I think that
it is helpful to try to clarify ethical considerations because I
think that what goes on often is, oh, my god, all these things are
really risky and dangerous, but there isn't specification.
And so I would agree that it is difficult to figure
out language, but I think that is the contribution that we could
make. I think that we did that in the cloning report and I think
that it was worthwhile.
And also I don't think that you would be avoiding
it by waiting until you try to put this into the options, because
I think you would run into the same sort of discussions. So for
what that is worth.
The other thing is that maybe there is a less
ambitious agenda that we could start with that goes some steps along
what Frank was saying, which is to have a chapter or two talking
about different mechanisms of regulation.
Everything — and that should include things
such as education, financial incentives, even tax policy. I mean,
there are all these different ways that are used to shape behavior.
And we ought to at least sort of set them out
briefly. But then throw out some options. Not every possible option.
So, for example, one option would be the FDA should cover certain
novel infertility techniques or procedures, and we might get into
— I mean, obviously there would be a lot of issues there.
But in terms of treating them as new drugs and devices, they should
go through the same kind of safety testing that other innovations
Another option would be maybe there should be
some sort of standing advisory body similar to us where at the Federal
level people could at least on an ongoing basis try to think through
some of these more broad concerns, such as family, and dignity,
and child protection, and respect.
And just to say, you know, here is some thinking,
and not necessarily to impose on anyone, because obviously that
is not something that the FDA is equipped to handle, and I think
that it might be difficult to include those considerations.
So another option would be model laws for States,
since States do have the authority to regulate medical practice
in general in our country, and should there be some sort of agency
set-up to write some model laws, specifically in this area that
States could pick up if they wanted to.
So not necessarily a comprehensive set of options,
but here are some possible options. Here would be a good size,
the bad size.
CHAIRMAN KASS: Gil.
PROF. MEILAENDER: Rebecca, I
don't want to ignore the ethical questions. I want to find
a way to discuss those in the context where they can be discussed
straightforwardly, rather than sort of in the indirect way that
always raises questions of do we really have a neutral document
That seems to me by letting those rise in different
possible regulatory schemes that one might or might not see in a
more straightforward way. I think the reason that in Section 3
that the document finds a good bit of regulation is as I said for
And for those historical reasons, there is in
fact a bright line, the principle of informed consent. And with
that bright line, you can proceed to regulate. The reason we have
so much trouble finding it in these areas is because we don't
have an agreed bright line. That is exactly what we are arguing
And it seems to me that we ought to just let that
fact emerge rather than sort of finessing it in ways that don't
really make anybody happy.
CHAIRMAN KASS: Anyone else on
the question of proceeding? Let me suggest that there are a variety
of suggestions not yet talked through here, that council charge
the staff with letting you know within the next two weeks exactly
what these next steps are going to be.
Part of our mandate we know. The question of
what — I mean, you see, Frank's comment is partly contingent
upon the future, and at least in my own thinking, whatever longer
term thing this council would do in this area, there would be some
merit in this two year term, and this our two year term, of putting
out what we can on the current state of practice.
And some suggestions of possible options that
could be pursued, and the strengths and weaknesses of doing so,
and also if there are areas of common agreement on some specifics.
And there is no harm if we have got consensus
on certain kinds of things, and no reason not to flag those for
our attention if we have some specific recommendations to offer.
But I would think that a realistic goal certainly
for this fall would be an improvement of this document, coupled
with one or another of these plans for how to think beyond where
we now are to the alternative ways of improving on the present situation.
But we certainly can't in the time between
now and the end of this Executive Order, and that we will know sometime
before too long on what the future might he.
But there is no way in the world that we could
start any of these large processes, the sort that — and assuming
we want to do that. It is not clear that we can undertake that,
and so I think a modest contribution in this area, with some suggestions
of alternatives, and the strengths and weaknesses, and the strengths
and weaknesses of doing nothing, are I think a useful contribution
to people's thought about this, at least as a short term goal.
Jim Wilson reminds me that we didn't say anything
about the commerce section. It's not that I have an aversion
to commerce, but let's have a brief comment on that if we have
them, and then we will have the public comments, and we will be
done on time.
PROF. WILSON: I have three comments.
First, the title. Certainly it should be called Commerce. Commodification
I think, is a mistake. Part of my decades long struggle with Marxist
language leads me to resist the notion of commodification.
Besides, it implies a judgment that commerce leads
to commodification when in fact we have no evidence to support that.
So, commerce should be the title.
On page 107, "the buying and selling of gametes
raises ethical concerns" possibly that this will lead to commodification
of reproductive tissue that "might diminish respect for procreation."
This is unexplained, and I find it implausible.
"Others additionally claim that it may taint
the otherwise altruistic motivations that lead individuals to denote
their gametes," when in fact a large number are paid to do
so. We even pay people to donate blood.
It seems to me that these come too close to slogans
to really be considered ethical concerns. And then finally on page
108 to 109, the bottom of 108 and 109, we seem to be endorsing price
control in this area.
The ASRM says that maybe you can pay $4,200 for
an oocyte, and possibly $5,000 if we justify it, but we should not
pay $10,000 or more. I don't know what basis they made these
judgments. It strikes me as completely implausible.
If there is a case for price control in gametes
that is better than the argument for rent control in New York City,
I have not heard it.
CHAIRMAN KASS: Any other comments?
Good. Thank you all for very careful attention to the document,
and thank you, Carter, and the rest of the staff for getting us
off to a very good start.
We will be in touch with council members on a
plan of work, and we will offer you some assignments, too. And
also please send in any specific further details along the lines
that comments have been made.