FRIDAY, MARCH 4, 2005
Session 5: Alternative
Sources of Human Pluripotent Stem Cells
Council Discussion of Draft White Paper
CHAIRMAN KASS: This fifth session of this 20th meeting
is devoted to a draft white paper of the President's Council
on Bioethics entitled "Alternative Sources of Human Pluripotent
Just to remind everybody and also to put this on the public record,
this white paper, a reworked draft of an earlier staff working paper,
grew out of discussions that we had at the last Council meeting
where we had two presentations, one from Drs. Landry and Zucker,
Columbia; one from Bill Hurlbut of our own Council, on alternative
ways of deriving pluripotent human stem cells that would not require
the destruction of human embryos.
Subsequent to that meeting, staff, in researching the literature,
also discovered two other kinds of proposals, one the attempt to
derive stem cells by biopsying living embryos, analogous to the
biopsy of living embryos used in prenatal genetic diagnosis; and
also, activities in the realm of attempts to find ever more de-differentiated
or undifferentiated stem cells taken from children and adults, encouraged
by the findings now of, I think, three different groups in addition
to Catherine Verfaillie's group of multipotent cells found in
the bone marrow, some of them bearing markers normally associated
with embryonic stem cells.
And the Council prepared a paper reviewing all four of these proposals,
first of all, explaining what they are, then conducting an analysis
to ask whether each of these proposals were ethically sound, whether
they seem to be scientifically sound, whether it was realistic even
to consider these matters, and that meant whether these were likely,
if successful, to be met with scientific approval, whether they
might secondarily be eligible for federal funding.
We did not take up the question of whether these things should
be recommended for federal funding. That was a prudential judgment
that rested upon answers to the ethical questions and also the next
question of how much resources should be invested in these kinds
of, for the time being, still speculative proposals.
The major emphasis in this document, since this is an ethics council,
has been on the ethical analysis, and the thought was that we are
convened here like a body that's conducting a preliminary hearing.
The question is: do these proposals pass minimum ethical muster
and, second, are they of sufficient possible scientific interest
that we could recommend them for further public consideration?
That has been the spirit here.
And I want to say a couple of things about why we are doing this.
You'll recall that this is a council which is charged, indeed,
with upholding certain ethical norms and at least venting all of
the important ethical questions connected with biomedical advance.
We have been involved in issues that concern embryo research, and
early on in our cloning report we prided ourselves, I think rightly,
and all of us signed onto this particular part of that cloning report,
that we recognize that all parties to the debate about embryo research
had something vital to defend, not just for them, but for everybody.
Also, this Council distinguished itself, in my opinion, in our
finding common ground in the Reproduction and Responsibility report,
notwithstanding the remaining large differences amongst on the moral
status of early human embryos, and it seemed to me, and I think
this was the sense of the group the last time, that this was a wonderful
opportunity for this Council to demonstrate once again the desirability
and the possibility of trying to find common ground and also of
seriously considering ways that science might advance in ethically
uncontroversial ways, in which neither side would have to compromise.
And it seemed to me a public bioethics body that could help in attaining
such goals would have more than justified its existence.
There have been people who have looked at our discussions, and
our discussions have gotten a lot of press, and there are also papers
being published about these things even as we speak. There are
people who have been cynically saying that all of this is an attempt
to distract the country and to divert attention from the need to
pursue embryonic stem cell research by the conventional means and
that this is a disingenuous conversation.
I reject that in the name of all of us. If there are any of you
who are speaking disingenuously, you're free to confess, but
I've been in conversation with everybody here, and it has not
been my sense that that is the motive of anybody who has been participating
in this discussion.
That's a cynical charge which to my mind ranks really with
those who say the people who support embryonic stem cell research
over adult stem cell research are really motivated by the desire
to kill embryos or to defeat their pro life opponents. That's
a canard. I reject that, and similarly, I think we should reject
those who would caricature what we're trying to do here as somehow
disingenuous and an attempt to deflect research.
I think everybody ought to be interested in finding morally uncontroversial
ways for science to proceed if we can and ways that would respect
the seriously held ethical opinions of our fellow citizens whether
we agree with them or not. Whether these proposals finally pass
ethical muster on their own terms is, I think, the question we want
to consider. These are serious proposals advanced by morally serious
people who are, in fact, committed to scientific progress, and so
are we all.
With that as a kind of preface, this is a session in which all
of you have had a chance to see the draft white paper. This has
been reworked in the light of your comments made on an initial draft,
in the light of comments made by three outside researchers whose
expertise bears upon the feasibility of these proposals.
I want to thank especially Adam Schulman and Dick Roblin who worked
heroically to put together what I think is really a quite remarkably
thorough and clear document at least in terms of the analysis.
I think most of our time probably should be spent on the question
of the conclusion and what we want to say by way of conclusion,
but before doing so, let me see if, on the sort of more general
questions, in terms of the ethical analysis and the document as
a whole, whether people find this a fair and balanced document,
whether it presents a sober and sufficient analysis of the issues,
before we take up the particular questions of the conclusion.
Are there any comments about everything up to the sort of conclusion
just in terms of the analysis that's offered? I don't mean
line editing, but more serious reservations, serious omissions,
questions of balance.
DR. HURLBUT: Well, it's a small comment, but I think
we should take the issue of parthenogenesis a little more seriously
than we have because there are some serious scholars and scientists
interested in that subject, and notwithstanding its mention in the
Dickey amendment, I'm not sure that it has been properly analyzed
I'm not committed to one view or another on the outcome of
that ethical deliberation, but I just think that since we know that
there has been successful procurement of embryonic stem cells from
parthenogenic primates and now apparently from human productions,
I think we ought to recognize it as already having practical import
and, therefore, ethical worthiness to at least be discussed more
thoroughly rather than dismiss it.
CHAIRMAN KASS: On this very point, anyone else?
PARTICIPANT: Is there a page you could give us reference
to or is this just a general omission?
DR. HURLBUT: It's on page 21.
CHAIRMAN KASS: At the center of this is this thought:
is a parthenogenetic blastocyst-like entity an embryo? That's,
in a way, the conundrum here.
Most people will say this is not an embryo because it cannot,
in fact, by your own criteria, Bill, cannot really develop and become
an organism. There's really only one experiment, I suppose,
that could prove that definitively. You would have to presume the
innocence, I think, of that experiment, I think, to try it, and
in the absence of this proof, there is a kind of doubt both on scientific
and moral grounds about just what this thing is.
And I'm not sure. Maybe there's more to be said on that
subject, but I thought we tried succinctly to say what the conundrum
is and why that conundrum is probably not going to go away. And
at the very least, as a practical matter, there is a certain bar
even to investigating this further, at least in this country.
Now, the Dickey amendment wasn't written at Sinai, and even
the things that are written at Sinai are under review, but I'm
not sure what more one would want to say here, but we will certainly
consider it, and if you have some specific suggestions for enriching
that discussion, I think we would be glad to have them afterwards.
DR. ROWLEY: Can I? Just for a point of clarification
as to how you plan this morning's discussion, it seems from
the way it has begun that we will consider the ethical issues and
then at a later time this morning go back and discuss some of the
scientific bases for some of these? I wasn't clear.
CHAIRMAN KASS: No. Thank you, Janet.
No, I thought that at least from the mail received before the
meeting that most of the discussion that people wanted to have was
— well, in fact, it stems really from Michael's comment
on the current draft that you have, namely, here we have this extensive
ethical analysis, and then it looked to Michael as if it were sort
of a cop-out to say, "Well, you know, some of us like this
and some of us like that," without our having actually had
So it was Michael's suggestion, and I concurred, that we try
to see where we are on a limited ethical question and it's also
a provisional judgment because some of these ethical judgments depend,
indeed, on certain empirical questions. I mean whether some of
these biological artifacts are or are not embryos might be discernable
from the animal research.
So I thought I would save the bulk of the time for the discussion
of the conclusions, and I'll cut this off if it gets too long
because the conclusions, I think, are the most important thing.
But if there are major difficulties with things prior to the conclusions,
this would be a good time to at least mention them.
And so if there are things earlier, Janet, this would be good.
DR. ROWLEY: Well, I think I indicated some of my concerns
at least in my first response to receiving a copy of the draft of
the white paper, and I do think that there are some serious issues,
and I will talk basically only about the Landry proposal and about
Bill's. And I think I was particularly troubled that we have
ourselves in what I find a quite unusual situation.
And on page 7 in the middle, under Item 3, "yet is important
to note that under the Landry-Zucker proposal embryos that divide
normally upon thawing but are allowed to die by a human decision,
that is, not to transfer them into a woman's uterus, would not
be eligible for donation."
So viable embryos are going to die at the same time one would
take those embryos that don't divide and, therefore, appear
dead for scientists then to be able to see if there's any way
to find within the few cells in those dead embryos something that
might then go on to be used for an embryonic stem cell line.
And I think that for me this is a strange way of solving an ethical
dilemma, that you let something that is useful die and then try
strenuously to rescue cells from a dead embryo.
So I think that in the apparently dead embryo it's clear,
and it's pointed out here in this discussion, they may have
chromosome abnormalities that would prevent their ever developing,
certainly not normally, and many of these chromosome abnormalities
lead to cell death.
So getting long-term embryonic cell lines out of these would be
I think with regard to Bill's proposal — and I realize
all of this is couched in the terms of this as at present a thought
experiment that has no basis in actual experiments — but I
think we do have to be very cognizant of the fact that this proposal
is based on using oocytes obtained from women, and it does include
the possibility that the women would be paid for it, though that's
going to be controversial and that's not central. So that it
says they can be donated. Women can be paid for them, but the feeling
of many individuals in the country and I think the proposal of the
National Academy of Sciences that is currently working on guidelines
will be that there be no payment for the donation of oocytes.
But I want to just point out what this really potentially means
in the real world, and we don't have very good evidence, but
based on the paper of Dr. Hwang from South Korea that was published
in Science in 2004, they used 176 oocytes for SCNT, somatic
cell nuclear transfer, and they got one stable cell line and that's
using a donor nucleus actually from the same individual who provided
the oocyte and under the best possible conditions.
And to say that you're going to go through a series of experiments
to identify a gene that will disable a human embryo or a human cell
such that it can't develop into an embryo, but it is otherwise
functioning, and to figure out which of several or probably quite
a number of genes might fulfill that requiremen, is going to take
many, many, many human oocytes, and I find that an extremely troubling
Moreover, once you get the embryo with this defective gene, you're
then going to do manipulations, presumably homologous recombination,
but there are several possible strategies, to rescue that defective
gene later in the course of the development of this cell line.
That, too, is fraught with a lot of problems.
So you're going to have enormous wastage all the way along
the line, and each wastage is the use of an oocyte donated by a
woman, and I think this is not a line of research that I at least
am prepared to support.
CHAIRMAN KASS: Let us move to the conclusions. I know
a couple of people have to leave early, and anyway, Janet has already
begun on the conclusions.
I can't, Janet, refrain from commenting just to the side that
ordinary SCNT, which a considerable number of members of this Council
were fairly enthusiastic and remain enthusiastic about, also involves
a rather large number of human oocytes as you began by indicating.
DR. ROWLEY: I don't deny that, but at least you're
giving them the best possible chance of developing into a usable
cell line. This takes that thing — and that's why I pointed
out the statistics from South Korea — one line from 176 oocytes
under the very best circumstances. We're going to talk about
one line probably out of 1,000 oocytes.
CHAIRMAN KASS: Bill, do you want to speak to that just
DR. HURLBUT: You know, Janet, I really welcome your well-expressed
concern about your oocytes. Coming from a prominent scientist in
our nation, to have such a serious concern about oocytes put forward
in plain English is very, very positive, I think.
I, too, share that concern, and in raising the prospect of altered
nuclear transfer, I am trying to draw on the best possible scientific
possibilities, while being sensitive to the moral concerns. And
one of the moral concerns I truly am concerned about is the procurement
I think if my project ends up inducing the superovulation of a
single woman to produce eggs, I will be disappointed. Now, there
are other possible ways to get eggs. There are leftover eggs from
the IVF clinics. There's talk of in vitro maturation
of eggs after ovaries are removed surgically or from cadavers.
There's talk of putting ovaries from such sources into animals,
and because of the conservation of the hormonal systems, there may
be ways to induce the formation of eggs.
All of that is science in rapid transition, and I think my project
would depend on morally acceptable ways to procure eggs. I completely
agree with you. The egg issue is a very, very serious issue, and
yet at the same time, the scientific community has promoted the
important possibilities of SCNT, has said that it's a far superior
technology to harvesting ES cells from IVF lines which cannot be
designed by genotype to serve as disease models, and so forth.
So the reason I put forward my proposal is because it seemed to
offer the greatest spectrum of possibilities while preserving the
moral notion. But I completely agree with you about the eggs.
So if that's a preemption for my project, it might also be
for all of SCNT, and then we're back to the starting block,
but I put forward my proposal in the spirit of defending both the
science and the ethics.
CHAIRMAN KASS: Let's proceed in the spirit of Michael's
suggestion that we see where we are on the individual proposals.
I'm going to say in advance that depending on how this discussion
goes, we would either modify the conclusion to express the sense
of the Council on these various proposals or go back to the more
wishy-washy formulation suitably modified to meet various people's
approval. I don't want to prejudge the wisest course until
we hear where people are in the discussion.
DR. KRAUTHAMMER: Well, perhaps I can just start it off
by saying where I stand on the proposals.
First of all, I endorse the effort. I read Mike Gazzaniga's
objection that it is a distraction. I don't think he meant
it as a disingenuous distraction, but a distraction from science,
and I think he's missing the point that we have a deep difference
in the country among large numbers of people over the ethics of
these procedures, and if we can find what's essentially a technical
fix, which is kind of a magical solution to an ethical issue, we
ought to pursue it, not to the exclusion of other research, but
we ought to pursue it.
So I think what you're proposing Leon is that at least we
look at the four proposals as extremely useful.
I'm rather inclined to support the first and the fourth, Landry-Zucker
and the de-differentiation. The last one is very obvious because
it's rather simple. It raises no ethical dilemmas, the de-differentiation
to the point of pluripotency, but not totipotency. So I think that
one is pretty obvious, and I'm sure there will be consensus
I'm intrigued by Landry-Zucker simply because it gets us around
the problem of destruction of embryos. If there are cells in what
we might call clinically dead embryos that can be used reliably,
there are tens of thousands of these embryos left over. It solves
our problem, and it would allow people who are not troubled by the
ethics of this to pursue traditional use of discarded embryos, live
embryos if they wish, perhaps without federal support, and those
who are troubled, to use the cells of the deal embryos.
And I say this as someone who has spoken here publicly and written
that I support the use of discarded embryos, living discarded embryos
in IVF clinics in stem cell research. I disagree with where the
President drew the line in his August 9th speech, 2001, although
I respect the reasoning behind it.
But even though I support the use of discarded embryos, I think
we ought to look seriously at whether or not Landry-Zucker could
work. If it does, it would allow us to pursue it in a way that
would be ethically untroubling to large numbers of Americans, and
I think that would be a great advance.
Oh, I might say on the others, too, that I'm a little bit
troubled by the biopsy notion, and also by the proposal that my
friend, Dr. Hurlbut, has proposed about the creation of what are
essentially teratomas. I find that troubling ethically.
I agree also with Janet's objection that, just on practical
grounds, it would involve the use of very large numbers of eggs,
but I think my objection is more that I'm not sure we ought
to be creating these bizarre organisms as a way to harvest stem
But anyway, I'll stop there. Thank you.
CHAIRMAN KASS: Someone want to respond or go next? Michael.
PROF. SANDEL: I agree with what Charles has just said,
and I think we should follow that suggestion.
I want to, having raised a question about a portion of the conclusion,
I want to say something about the analysis in the document prior
to the conclusion. I think it's superb and thoughtful and carefully
done. And I'm speaking here especially about the ethical analysis.
I'm less equipped to judge the scientific analysis, but I think
the ethical analysis of these four proposals in the white paper
is very powerful and extremely well argued, I would say the best
and most carefully and, to my mind, persuasively argued of the documents
that we've put out. So I think that's something we can
be proud of.
My objection was to the conclusion and to the lack of fit between
the ethical analysis presented in the white paper and the last paragraph
of the conclusion.
And what I would propose, and this is consistent with Charles's
suggestion just now — I would also want to draw attention,
by the way, to Leon's memo where he summarized as a point of
departure for our discussion the ethical evaluation of the four,
and I think that's a perfectly reasonable statement of the ethical
I'm referring here to Leon's memo, and I would much prefer
that we substitute for the last paragraph of the conclusion something
that captures Leon's summary of our ethical analysis in the
memo, and I actually have specific language drawn from the two to
suggest if it's of use, and it would embody, I think, the view
that Charles has just stated.
If we go to the last paragraph, the thing I objected to was simply
saying "where ethically appropriate," as if we were agnostic
on that question as a bioethics body, and I think that problem is
corrected precisely by Leon's memo.
So what I would suggest is that we amend the conclusion, beginning
in the second sentence, the one that begins "because the Council
is wholeheartedly committed to both the advancement of science for
the betterment of humankind and to the defense of human freedom,
dignity, and the value of life," comma, and then I would say,
"We encourage public discussion of any proposal to achieve
these ends," period, and then say, "Of the proposals we
consider in this paper, we endorse scientific exploration of Proposals
1 and 4," in line with what Charles has suggested, and then
drawing on what Leon has summarized in the memo something like the
For reasons stated in the ethical analysis, we consider Proposals
2 and 3 ethically unacceptable in humans at least for now.
CHAIRMAN KASS: Robby.
PROF. GEORGE: Yes. I'd like to say a word on behalf
of the altered nuclear transfer proposal that Bill has put before
us. I think it's important to understand what that proposal
is, as Bill described it to us in the last meeting of this Council.
It is not a proposal to go forward at this point with the use
of human cells. Rather, it is a proposal to conduct animal experimentation
precisely with a view to determining to a high degree of certainty
that we can create non-embryonic entities that are capable of generating
embryonic type, pluripotent stem cells.
Bill also said then what he has reiterated this morning in response
to Janet, that he would not like to see his proposal go forward
if it did involve having to obtain eggs by subjecting women to superovulation.
Now, I think what that means is that in endorsing Bill's proposal,
we are simply endorsing going forward with that basic animal research
to take things to the next step while at the same time hoping, as
those who support SCNT no doubt hope, that we will be able to come
up with ways to meet the need for eggs that don't involve subjecting
women to dangers and exploitations.
So I think with that understanding of Bill's proposal in mind,
we can add to what Michael has just said, an endorsement of the
continued discussion of Bill Hurlbut's proposal or continued
investigation of Bill Hurlbut's proposal as well.
CHAIRMAN KASS: In animals.
PROF. GEORGE: Yes, precisely in animals. I would reiterate
what Bill said last time on this score, that the only way that the
proposal is being put forward only on the assumption or in the hope
that what will be created, the teratoma-type entities that would
be created, are truly non-embryonic entities.
Bill himself said very clearly on the record that he would not
want the proposal to go forward. He would not want this to be practiced
if it turned out that what was being created was merely a defective
embryo or an embryo that's pre-programmed for an early death.
It would have to be a distinct non-embryonic creature for Bill to
— not "creature," but an embryonic entity —
for Bill to endorse it, and that would certainly be true for me
and I suspect for other members of the Council who share our view.
DR. KRAUTHAMMER: I'm afraid it was that slip that
really troubles me about this proposal.
CHAIRMAN KASS: Charles, would you speak up?
DR. KRAUTHAMMER: I'm afraid it was that slip of the
tongue which troubles me about this proposal. You call it an "entity."
I see it as a "creature," and I think that's a fundamental
difference, and that's why I'm repelled by it in principle,
apart from all of the issue of obtaining oocytes.
PROF. GEORGE: Could I ask Charles a question?
DR. KRAUTHAMMER: Yeah.
PROF. GEORGE: Yeah, just to be clear, do you consider
teratomas and complete hydatidiform moles created in nature to be
creatures as well?
DR. KRAUTHAMMER: I think it was a targeted missile that
went wrong. It was perhaps — look. It's philosophical
here. It's on point — it was an attempt at a human that
didn't go right. I'm not sure we ought to want to reproduce
I mean there are other ways to deal with our problem of obtaining
stem cells without killing embryos, and this one I find is simply
the most troubling.
It could be what Leon calls sort of the wisdom of revulsion, and
I haven't, you know, done an extensive philosophical analysis,
but if you've seen a teratoma or you think about development,
I'm not sure we want to be in that business.
PROF. GEORGE: Well, let me just point out in response
to Charles that I think that there are two distinct questions here.
One is: do we, in fact, have a creature or was my slip of the tongue
And I think the answer to that is, frankly, no. We don't
have a creature here precisely in the same sense we do not have
a creature in the case of a teratoma or complete hydatidiform mole.
The second question is the one I think actually bothers you.
It's not the question of a creature. It's the question
of: is it ethically acceptable to create something that even in
nature is repugnant and weird.
Now, I don't share your principled ethical objection to that,
although I understand —
DR. KRAUTHAMMER: Repugnant, weird and somewhat human.
If it's just repugnant and weird, it's just an aesthetic
issue. If it's somewhat human, it's a moral issue.
PROF. GEORGE: Somewhat human in the sense of possessing
a human genome?
DR. KRAUTHAMMER: Yes, and is an aborted attempt to produce
a human essentially. I mean, it is an attempt to produce a human
that went wrong.
CHAIRMAN KASS: Just procedurally, because I think we have
probably started the discussion that is the one most to be sustained,
let me see if I can get agreement. Let's see if the Council
agrees on the other three things so that we can spend all of our
time on this and see where we are.
The provisional formulation which Michael has at least endorsed
on one, two, and four is as follows. And, by the way, I would like
to modify slightly that we don't recommend for scientific exploration.
That is not finally the judgment. Ethically acceptable for investigation
PROF. GEORGE: Yes.
CHAIRMAN KASS: — that's kind of a minimal threshold
I think we should say.
The rest is the matter of prudential judgment of resources and
the like, which I don't think we're in the position here
DR. KRAUTHAMMER: But couldn't we say that we encourage
this research in the name of finding some ethically consensually
accepted way of obtaining stem cells?
CHAIRMAN KASS: I think that's what —
DR. KRAUTHAMMER: It's implicit. So why not say it?
CHAIRMAN KASS: It's implicit partly because I think
this was a question raised by Janet already in the comments on the
last draft. Resources are going to be put into this.
DR. KRAUTHAMMER: But it would be stronger if we were explicit
in what is obviously implicit here, that this ought to be looked
at without giving it a dollar figure.
CHAIRMAN KASS: We now have a new question for deliberation.
Let me put that one last, but —
PROF. GEORGE: Leon, could I finish one remaining thread
with Charles just very quickly?
CHAIRMAN KASS: It won't be quick, but go on.
PROF. GEORGE: No, no, it will.
Charles, just to —
DR. KRAUTHAMMER: It's not fair. He was thinking on
this while you were talking.
PROF. GEORGE: On the objection to the creation of the
entities, just to be clear, your objection is precisely to creating
such entities. It's not the objection that I and others have
to the use of embryos in this regard where the objection is to killing
You're not objecting to killing teratoma-type creatures.
Your moral objection is to creating them. So they're on a different
DR. KRAUTHAMMER: The answer is yes.
CHAIRMAN KASS: The first proposal, cells from organismically
dead embryos, it's ethically acceptable for investigation in
humans, but with the IRB-type caution about the need for observing
the stringent guidelines, Janet, we will deal with you directly
on that other question that you have raised about the way the text
reads at that particular point.
DR. ROWLEY: Yes, but I emphasize that because that's
exactly what's going to happen. So I think to be honest, you
have to say that perfectly normal, viable embryos, at least as determined
at the four-cell stage, will die, whereas you will then spend vast
efforts to try to rescue some cells, potentially normal, but potentially
abnormal, from these dead embryos.
I just raise the question: is this an ethically appropriate way
CHAIRMAN KASS: Okay. The somatic cell de-differentiation
studies, ethically unproblematic. Is there anybody who would disagree
with the conclusion on the second proposal, the blastomere extraction
from living embryos, ethically unacceptable in humans at least for
now owing to the reasons given in the unethical analysis?
Most especially, we should not impose risks on living embryos
destined to become children for the sake of getting stem cells for
research, not even for their eventual speculative benefit to the
donor child. Okay to study this in animals.
Is there anybody who would dissent from those sort of provisional
DR. ROWLEY: I don't want to dissent, but I think that
one should omit the last phrase because it's much more effective
to get cells that could be potentially useful to the child if they
were needed by that child in the future from cord blood, and this
is done as a standard procedure everywhere.
So to take a blastomere to set up a cell line that may be useful
for the child is not something I think that the Council should be
considering or endorsing because saving cord blood is much better
CHAIRMAN KASS: Thank you very much, and that will be added.
That's an important omission.
Are we okay on the others? Bill.
DR. HURLBUT: I'm not quite clear what we're doing
here. Are we — you sent the note at the last minute about
evaluation of each of the proposals individually. Are we now talking
about including that somehow in our white paper, adding it on as
something, or are we just discussing how we feel about things?
Because from a practical perspective, I think we're making
summary statements that are at this point in our deliberation on this,
whether we intend to go forward in it or not, we are not prepared
to make, and I would cite even just one and four, which have been
given a nice endorsement thus far. I personally think that many
of the same concerns that Charles has raised could be raised reasonably
about one and four.
I mean, take four, for example. De-differentiation; at first
glance we use a certain understanding of what's going on biologically
to say, "Oh, that's nice. We add a few chemicals and it
That's not at all clear what it would involve, de-differentiation,
that is. We don't know if there's a sequential patterning
like the building up of a building that's necessary for establishing
pluripotency. That is very likely, as *embryogenesis is a process.
We don't know whether we would need eggs, for example, to
do it because cytoplasmic factors from oocytes are probably the
chemicals you need to do that. So it might involve huge numbers
of eggs to do de-differentiation.
The objection that is sometimes raised about my proposal is that
it's very close to human, although indeed it would not be human
by the understanding that Robby and I share. Well, if you take
de-differentiation, you take it down to within one molecule of being
totipotent, then is that not close to human? Just because you came
I think, in fact, the little dialogue that went on there a few
minutes ago points to the difficulty of all of these discussions,
and just to step back for a moment to proposal number one, if you
read Janet Rossant's comments, she's not clear about the
moral meaning of proposal number one either. She says that the
scientific definition of the word "organism" is not at
Besides that, there are interesting and important ethical questions
about the practicality of actually knowing if a single cell is either
totipotent or if, when taken out of the culture and placed into
a womb, it might actually grow. If you talk to the people who work
in IVF clinics, which I've done extensively, they say it's
pretty hard to predict. As Janet Rossant clearly says, they've
been searching for this marker of lethality or no longer viability
of the embryo and they haven't found it yet.
That's not to say that's not an empirical study, but it
also involves a deeper ethical analysis than we've done here.
My understanding of our whole project was not that we were going
to do the natural process of a serious ethical Council like ours,
which would involve hearing proposals, taking testimony, doing serious
deliberation and then comprehensive moral analysis. We surely have
not done that yet for any of these proposals.
What we have done is a pretrial hearing to say whether there's
a case that merits serious consideration. I think we should say
that all four of these proposals do merit serious consideration,
and at this stage, nothing more for any of them really, except maybe
observing embryos; nothing in the way of humanly involved engagement
because we're not quite there yet.
If we end up by adding summary statements about individual views
of each of these proposals, we will be jumping way ahead of ourselves
as a serious ethics council into statements that will be taken by
the public and the press as being conclusions, and we're not
ready to make judgments.
We've done the pretrial hearing. We say there's something
worth investigating. To stop at this point would be to stop halfway
through the trial when we only have sort of hearsay and a few comments,
not cross examination, not cross-testimony.
I think many of the things that have been raised about my proposal
I think I can easily answer, but I've not had a chance to do
so, and that might change people's point of view. After all,
the whole point of this difficult debate is that we talk it through,
not just politically posture.
CHAIRMAN KASS: Jim Wilson.
PROF. WILSON: Would it be helpful if instead of revising
the last paragraph of our conclusions we cut it very short by ending
it with the first sentence? So that we would say, "Despite
these differences among us, and we recognize there are differences,
the Council shares the view that the proposals here discussed and
others like them that they may stimulate deserve careful and serious
consideration," period. Go no further.
CHAIRMAN KASS: Does someone want to speak directly to
— no, wait. It's Jim's point in response to Bill's
PROF. FUKUYAMA: Well, I guess it kind of depends on what
you then expect to do afterwards. I mean, is this a prelude then
to another council meeting or two in which we actually do, you know,
what Bill suggests and do a much deeper analysis of each of the
four, or do we just throw it out there and say, well, someone —
because I do have some sympathy for the point that Michael made
that if we don't do this analysis, who's going to do it.
I mean, it does seem to be that that's kind of our charge here.
PROF. WILSON: Well, Michael, I believe, has said that,
given the present state of our knowledge, the ethical analysis of
these four proposals is, I believe he said, sharp, clear. I forget
the exact adjective, but it was quite positive. To do more than
that requires a substantial advance in scientific knowledge so that
we know what we're talking about.
We can't even adequately describe these things. We're
inventing names as we go along, and unless there is more research,
we can't have a trial. We are saying that there's probable
cause to go forward and look at these matters, but we don't
know whether any of them will pass the test of useful beyond a reasonable
doubt. And that can only come about when science has advanced much
further than it is.
So I'm saying all we can do at present, even if we spent another
ten days on this, is essentially the analysis we have because that's
based on all we know, and therefore, we should simply say these
matters deserve careful and serious consideration.
Now, at some point the Council should continue its existence,
may gather more information and you can come back and take a closer
look, if not us, then other bodies. But I don't imagine this
is going to happen for some time because the research is going to
DR. KRAUTHAMMER: May I just interject here, Leon?
But to be completely agnostic here, I think, is a little bit disingenuous.
In the absence of new scientific evidence, would we not here unanimously
agree that the removal of a blastomere from a living embryo in order
to produce these stem cells would be unethical. I mean, do we need
a lot of evidence on that one?
Is that number three or number two?
CHAIRMAN KASS: Two.
DR. KRAUTHAMMER: Number two. I mean, what's the scientific
evidence that's lacking that prevents an ethical decision here?
CHAIRMAN KASS: Gil.
PROF. MEILAENDER: It may just be that I'm sloppy,
but I think we've done a good bit actually. We haven't
done everything you might want, Bill, but it's not as if we
haven't done a decent amount.
And I think, therefore, that I agree with Michael's general
point that we should not simply punt at the end, but we should reach
I actually think — I mean, as you know, I'm not ordinarily
one who cares whether we reach consensus or not, but I think we're
not that far from a kind of consensus here. I don't have a
problem with language something like the language Michael suggested
that we're prepared to endorse two or three in humans right
I'd be happy to say something more positive about three with
respect to animal studies rather than just let it go as an assumption,
say, you know, it would be good to do the animal work in order to
try to determine what actually is happening.
So it seems to me that, whatever reservations different ones of
us may have with respect to one or four, those are not reservations
that lead us to say science should not conceivably go forward investigating
these more. I mean, after all, our mantra has generally been that
science proceeds on as many fronts as are ethically acceptable,
and we're trying to figure out whether there are insuperable
ethical objections here.
And it seems to me that, whatever differences we have with respect
to, well, three in particular, I can't see that there are insuperable
objections to our saying something positive about doing animal research
in connection with it while regarding it as for now unacceptable
in human beings.
So that, granting that there is more that could be done on discussing
any of these, I do work with the assumption that we have actually
done a good bit, that we've not done nothing, and that we're
not that far from conclusions which almost all of us could share
even with slightly different intonations about, you know, how we
feel about them.
CHAIRMAN KASS: Jim wants a brief response.
PROF. WILSON: Thank you, Gil.
I very much share your general view. Perhaps my effort to reach
a conclusion by getting rid of language led me to get rid of too
much of it. Perhaps we could take that first sentence in the last
paragraph and say that the Council shares the view that Proposals
1, 3 and 4 here discussed and others like them that they may stimulate
deserve careful and serious consideration, and then perhaps add,
if you wish, an explicit reference to animal studies.
If you all feel now that two is ethically dubious, I don't
believe three at the present stage is ethically dubious from the
point of view of further research. Two from my most elementary
scientific knowledge could fall on the other side of the line.
CHAIRMAN KASS: Dan Foster.
DR. FOSTER: Well, you know, I think we can have some statement
about animal research, but you know, the world of science, if it's
perceived that any of these ideas have potential, it will be explored.
I think Bill and a colleague are already planning studies. I think
I read it in some press. So those studies are going to go on whether
we say it or not if there's thought to be scientific viability.
I don't mind mentioning it as a guardian thing, but I don't
think that that is a big deal because that's what scientists
do, I mean, and this stuff, you know, has been in the papers and
so forth. So I think it's sort of automatic that that will
go on whatever we say.
I mean, if it is thought that somebody can do that whether they
have moral inhibitions or not, you know, they might go ahead and
do that. So —
PROF. WILSON: The science may go ahead, but our job is
not to direct science. Our job is to direct policy makers and the
attitudes they should have about science.
DR. FOSTER: I understand that, Jim, but I mean, you and
others have brought up about the fact that we need to encourage
or we should encourage scientific experiments in animals to see
where these things are going.
When altered nuclear transfer came up at the last meeting, I was
tremendously enthusiastic about it, and I still really admire Bill's
thought about it. The more I've thought about it and read about
it, I've somehow come a little more towards the view that Charles
And I wonder if in terms of the conclusion one might alter it
a little differently along what Michael has said, that with our
current understanding that we believe that one in four have no immediate
ethical restraints for potential use in humans; that the issue on
three is such that it may well move into this category, but because
of the number of questions that have arisen, some in my mind, some
are worried about making something that's — in a way,
I sort of thought that even though one understands why we use the
term "teratoma" and so forth, it might not have been the
best analogy to what we're trying to do, I mean, it seems to
So I would myself be in favor of the proposal that has come from
Michael and Charles to say that, at this state in our knowledge,
one and four appear to us to be ethically acceptable and that the
potential for three may well move into that category, but at this
point we are not willing to do that.
I think I'm in that stage, even though I probably was more
verbally supportive of Bill's idea, or somehow it has begun
to bother me a little bit. So I just raise that possibility.
CHAIRMAN KASS: Peter and then Paul.
DR. LAWLER: I like the image of the pretrial hearing,
that we really don't know enough to make a judgment about any
of these, and the more we move towards definite judgments, the more
I back away.
I'm not sure I would segregate Bill's proposal, enough
though I have objections to it or concerns, and not so different
from the ones Dan has, and two big ones that have been mentioned.
I wonder about the prudence of engineering a third category that's
not life or non-life but kind of a near-life experience. This may
not be deeply morally problematic, but I wonder about the prudence
of doing that.
And I also wonder about using reproductive materials for reasons
having nothing to do with their natural purpose, which I think Bill's
proposal suggests he would do.
Having said this, this proposal still has promise. It merits
research in animals, and it merits Bill's persuasive work.
He hasn't persuaded us yet, but he's an energetic guy.
He will continue to try to persuade us.
From my point of view, it passes the pretrial hearing test. It's
ready to go to trial, and it's going to be a long trial, a difficult
trial, I hope a nationally televised trial.
DR. LAWLER: And I think all of the other proposals finally
are in that category, too. We don't endorse Bill's proposal
in terms of experiments on humans now, but he's not asking for
that. It's not like it's something he wants.
With respect to the dead embryos one, that demands investigation,
I mean, observation of human embryos.
Number four seems to me in such early stages of development we
don't know what we're talking about. Nonetheless, we can't
help ourselves, and number two, the ethical objection raised by
Charles and others, I think, is obvious for now, but that, too,
can change through further scientific development.
DR. FOSTER: Well, in terms of four, let me just interrupt
there. There are at least three and maybe four papers that I know
about that with small molecules you can at least with myotubules
move back to make a myotubule, you know, make fat and bone and so
forth. So I don't think that we're devoid of evidence that
that might work. I don't know about the issue of pluri- to
totipotential cells. I mean, I don't know, but I do think that
there is enough evidence on four that you could say that that's
potentially a useful thing.
CHAIRMAN KASS: Excuse me. Paul is next in the queue,
but Charles I know has to leave. Are you watching the time? Do
you want a last comment before you go?
DR. KRAUTHAMMER: I'm going to stay another 15 minutes
and then go. I'll wait a little bit longer then.
CHAIRMAN KASS: Thank you.
DR. McHUGH: Well, I want to come back really into the
discussion that Michael gave and make the issue of this product
more personal. I read it and thought it was a wonderful document,
very clear, very coherent. It included all of my concerns in relationship
to all of these, and I was so pleased with what it had done, Michael,
that I simply read the last paragraph as your sentence, Jim.
And then I think Michael made a wonderful pickup, in other words,
in a kind of editorial pickup that we would have, if it were sent
out the way we had originally, we would have been marked by other
people, and we might well have woken the next day and said, "How
did we forget that?"
And so I'm very interested in going beyond Jim's sentence
to express what Michael has proposed, and I think Charles and Michael
and I are seeing commonly these clear themes as being easily expressed
in terms that are the charge of this Council; that these are clearly
things — at the present time if new knowledge came around,
we might well change our mind in relationship to it, but one and
four seemed ethically coherent at the moment.
Two seems to me unless — two is on life supports. As far
as I'm concerned, in order to have two, you'd have to do
something very radical to save it.
And three, Bill's suggestion, I think, has sufficiently problematic
issues, sufficient red lights, as I put it before, to make us say
that has to be something that will go forward in animal research
to find out, just as Janet said, that no scientist — for example,
I share Charles's view about these things as being creatures.
I share the idea that it's also a kind of pollution of the human
genome that I have a yuk factor towards, and I am equally concerned
that fundamentally it has — since I think the SCNT normally
without fooling around with it also won't become human —
I think this is painting the lily, and I think scientists will soon
On the other hand, I think Bill has made a persuasive argument
to do more research. I come back fundamentally to supporting what
Michael said. The combination of what we did added to the thoughts
that Leon's memo had would be a very appropriate final product
for this session to achieve.
CHAIRMAN KASS: Bill, do you want a quick response? Yes.
DR. HURLBUT: You know, first of all, I want to say plainly
that in raising my proposal, I'm trying to defend the important
goods being defended by both sides of this issue and differently
expressed by all of us in this Council.
I personally believe that a decent society does not build the
foundations of its biomedical science on the intentional creation
and destruction of human embryos. That's a fundamental starting
point for me personally, but as a person trained in science, as
a physician, as a father of a handicapped child, as a person who
has seen the possibilities of the science, I also want to try to
open the science.
I think some of you are raising prudential concerns, and you have
to put into the balance of the prudential concerns about my proposal
the tremendous possibilities and positive goods that could come
Now, I know that, getting down to the crux, I resonate with what
Charles is saying and what you're saying. Red flags go up in
my mind, too, but as Leon expressed, some concepts of manipulation
of human life are unbeautiful.
Disease is also very unbeautiful, and we do things in medicine
that are strange and unintuitive. We give people a dose of disease
for vaccination. We send in reengineered cells like targeted toxins.
We grow great sheets of skin from cells harvested from foreskins.
We cut the body. We do things that are not easily and intuitively
aesthetically pleasing for the very purpose of a higher good, which
I, on the other hand, would never favor the creation of something
I thought was a living human being for its destruction, but the
very point of this difficult dialogue, and I think it was characterized
in this exchange here, is we have not as a society nor even as a
Council actually contended seriously with the question. We have
not reached a consensus conclusion, nor really even properly deliberated
on what is the definition of an organism, an embryo and the moral
thing we're trying to defend.
We are in a transition time. We are at the beginning. We've
gone from genomics to proteomics, the genes, the proteins they produce.
We are at the beginning of the era of developmental biology. From
here on out, those questions, what is an organism, are crucial questions.
I think it's going to be evident in our next session. What
are the boundaries of humanity with regard to chimeras? What are
parthenotes? What are you going to do with the products that you
produce with embryonic stem cell research? Once you differentiate
them, are you going to reaggregate them? Are you going to grow
human parts apart from bodies? Are we going to have factories of
kidneys? Are we going to grow brains in vats? It's just simply
challenging conceptual issues here that we have not yet contended
And just one final point. Paul, you yourself have argued and,
you know, with a certain sympathy from my side, that what we call
cloning for biomedical research, or SCNT, is not really a reproductive
process. It's a lab process. It's not really the production
of a new human being, you've said. It's an extension of
bodily being of the individual.
I have some sympathy with your perspective on that, but am uncomfortable
because it's clear that Dolly, if she was a sheep, Dolly was
once an embryo.
So I agree it's a proposal called altered nuclear transfer.
In fact, in July 2003, Rudy Jaenisch came to our Council and explained
that all cloning for biomedical research, all SCNT, in fact, involves
altered biology, and I've got the quote from you here, and these
are the words of Michael Sandel, who says, referring to Jaenisch's
comments and how your attitude had all along been right, and that,
in fact, this produces an entity that is not capable of becoming
a human being and, therefore, is moral.
Michael speaks of the vindication of Paul McHugh's attitudes.
Remember? And then he goes on to say of Rudy Jaenisch's comments,
"And he argued that there is a difference." He's
affirming now that this entity produced by cloning is not a human
being. "And he argued that there is a difference, a biological
difference, with a possible ethical significance between a zygote
and a clonote, between a fertilized embryo and an artifact created
in the lab, and he was told that this is an eccentric position,"
namely, you were told that it was eccentric.
Well, you argued this. Rudy Jaenisch confirmed it, and all I'm
trying to do is really confirm it biologically.
Janet Rossant has —
DR. McHUGH: Let me just say, maybe just finish that point.
That's a very good point, and my point is this then becomes
making an ANT; it becomes painting the lily, and no scientist will
bother to do it for all of the reasons that Janet has said, that
is, that it will consume eggs. It will ultimately — you know,
it is my opinion the SCNT does produce, in the primate, a nonviable
Other people disagree with me on that, but I don't think that
the step to then poison it further .-
DR. HURLBUT: Poison it?
DR. McHUGH: — is even necessary.
DR. HURLBUT: What are you talking about? It has already
got five percent of its genome improperly expressed even in the
newborn form of clones. There's a massive reorganization of
the epigenetic factors. This is just adding a sure confirmation
DR. McHUGH: Okay. Well, I mean, there is our distinction.
I don't think you need to do more than is already damaged in
CHAIRMAN KASS: I'm going to try to hold a bit of order.
DR. KRAUTHAMMER: I'm sorry, but may I make just a
final statement because I'm going to need to go, if I could
just respond? I don't mean to interrupt.
CHAIRMAN KASS: Your final statement, not everybody else's.
DR. KRAUTHAMMER: Yes, I did mean mine. I wasn't speaking
on behalf of the Council.
CHAIRMAN KASS: No, thank you.
DR. KRAUTHAMMER: Look. I'm sympathetic to Bill's
seriousness and his attempt to bridge the difference between our
ethical concerns, our scientific concerns, and I happen to share
the principle that you enunciated, that we ought never create human
embryos in order to destroy them, which is why I support the use
of discarded embryos in IVF clinics, because I consider that a different
category, and why I oppose research cloning.
But I believe that a teratoma is a tragedy, and we ought not be
creating tragedies deliberately. That's just a shorthand.
Given that that view at least has some support here on the Council,
I'd suggest that we not be entirely agnostic; that we speak,
if we have a consensus, as I think we do on numbers one and four,
express it explicitly. I think it's an advance. It will help
to encourage that research and legitimize it.
I would also add the word "encourage." I think you
want to discuss that a little bit later, Leon, but I don't see
any reason why that ought to be only implicit.
We ought to explicitly rule out number two, which I think we have
a consensus on, and of course, when we preface all of this by saying
that the science is shifting, and if the science evolves in a way
that causes reconsideration, we're open to reconsider all of
these numbers one through four and perhaps end up with three.
I happen to oppose it in principle, but I'm speaking only
personally, but perhaps we could state consensually that there are
some ethical issues still unresolved, and we would, therefore, perhaps
permit it in animals and not in humans, although I would oppose
— I mean, I would not oppose, but I would be a little bit
troubled by pursuing it in principle.
But I would offer that as a way to perhaps bridge our differences,
have a statement that would be strong, and would launch an area
of thinking in research that I think would be extremely useful and
And I apologize for leaving in the middle of a brawl. It's
always interesting and enjoyable, but see you next time.
Thank you very much.
CHAIRMAN KASS: Thanks, Charles.
I have Ben Carson, Diana, Janet, Gil, Michael, Frank. I want
to hear from everybody. That means Rebecca and Alfonso, too, before
What did I say? Ben.
DR. CARSON: Okay. First of all, I thought the white paper
was well done. It was a good overview and very easily understood.
I think that's very important.
I would like to say that, you know, three years ago many of the
things that we're discussing in terms of these four proposals
would not have been on the table, and yet there was a raging debate
going on about stem cell research and its potential for good.
I think we need as a Council to make sure that we do ferret out
those things in these proposals that we agree with unanimously because
we want to maintain our relevancy, and we don't want to be so
tentative that nothing we say means anything.
But I think at the same time we need to recognize that there are
more than just these four proposals. There are going to be a lot
more than just these four proposals, and we don't want to give
anybody the impression that these are the only things that are being
looked at and considered.
CHAIRMAN KASS: Thank you very much.
DR. SCHAUB: Yeah, it seems that there are a number of
suggestions on the table about how to slice these, and some want
to put one and four in one category and two and three in another
category, a yes category and a no category. Others would slice
it differently and put one, three, and four in the yes category
and two in the no category.
I guess it seems to me that the way it's stated in Leon's
memo is pretty good. I would be in favor of not trying to lump
them into categories, but discussing each one separately.
And I think the statement that's given here is maybe pretty
accurate about what the consensus is. I would be in favor of somewhat
strengthening the endorsement of number three. I mean, the three
elements in there should remain that we think it's as of now
ethically unacceptable in humans, but despite the serious ethical
concerns that some folks have about the proposal, we do think it's
worthy of being pursued in animals.
I mean, I guess I'd sort of like to know is there a consensus
about that, about pursuing it in animals, and if there is, then
that could be stated somewhat more strongly in the assessment of
CHAIRMAN KASS: Thank you.
It is how to find the right balance that this discussion is supposed
to give guidance, and that was a very useful suggestion.
I have Janet, Gil, Michael. Michael, do you want a last word
before you go, too?
PROF. SANDEL: I apologize that I have to leave early.
First, two comments. First, on the moral arguments, I think it's
very difficult to read the pages 16 through 19, the ethical analysis
contained in the white paper unless one has, as Bill may feel he
has, persuasive arguments to each of those four ethical objections
and not to regard proposal number three as morally dubious.
Those are devastating arguments, I think. I'm talking now
about the ethical analysis in Proposal 3 on pages 16 to 19, not
about the conclusion.
And different of us weigh those, find those arguments some more
persuasive than others, but the one that I find most persuasive,
just to go to the moral merits for a moment, I think that regardless
of our other disagreement about the moral status of the embryo,
there were some of us who have an equal moral status view and others
who had an intermediate status view, and we had long arguments about
But it seems to me that even on the intermediate moral status
view, on that view to do the stem cell research and to destroy the
blastocyst does carry a certain moral burden that requires that
the use be restricted to lifesaving and morally weighty purposes
so that it couldn't be used, for example, to develop a new line
of cosmetics. That's the intermediate moral status view.
Even on that view, there is something, and here I speak just for
myself, something morally creepy about genetically engineering a
mutant embryo-like being and then saying with that being you remove
even the moral weight of justification that this must be used only
for especially important lifesaving purposes.
And so I think that's captured in Charles's invocation
of the kind of saying it's weird. If it's somewhat human,
Number three, objection number three doesn't depend on any
scientific discovery. Number three, it's the third ethical
objection laid out worries about it, regardless of what the creature
or the being or the thing created, the artifact.
So I just wanted at least to state why even — well, I don't
think it depends what moral status one attributes to the embryo;
that it's still possible to make sense and be moved by some
among the four moral objections laid out in the white paper.
CHAIRMAN KASS: Thank you.
On that point, I'm going to keep Bill from responding on this.
DR. HURLBUT: Please.
CHAIRMAN KASS: Very briefly, but I really want to keep
— there are people waiting to get in on this.
DR. HURLBUT: Michael, you're saying that the slight
difference between what I'm proposing and what Paul called the
gilding of the lily; you're saying that that is more of a mutant
human being in some sense, those loaded words? You're saying
it's more than what you've called for publicly, the endorsement
And second —
PROF. SANDEL: Yes.
DR. HURLBUT: — I want to ask you. I assume you've
read my comments that I made for the President's Council's first
report. Have you, in fact, read through them carefully?
PROF. SANDEL: Yes.
DR. HURLBUT: And you don't find any of those —
can you cite back for me my arguments perhaps?
CHAIRMAN KASS: Bill, I think —
DR. HURLBUT: I mean, it's like I don't think you've
read them, frankly. I don't get the sense of —
PROF. GEORGE: Bill.
CHAIRMAN KASS: Bill, I'm going to intervene, and let
me say that I think Michael has pointed to the place in the analysis
where there are ethical objections to ANT itself, not depending
on slippery slope, not depending on the egg question, not depending
upon the question of whether answering this question which can only
be empirically or at least partly empirically answered. Is this
artifact really a defective embryo or something else?
There are people who have these kinds of concerns. Here is the
place where I think the document has been one-sided, and if Bill
has answers to these objections, as he says he does, then that document
has to be corrected so that those particular objections can be countered.
I think that's simply only fair.
We've made the slippery slope arguments and then finished
by remarking that, look, slippery slope arguments always presuppose
that people cannot find the means of finding some boundary where
you can hold the line between what's acceptable and what's
objectionable, and I think we ought to balance this up and similarly
add something on the egg question.
But I think, look, everybody has to acknowledge — Bill has
to acknowledge, and I think Michael is speaking for himself and
perhaps others — that there are some people who do find this
particular kind of practice aesthetically or morally troublesome
to the point of dubious and in some cases unacceptable, and that's
a difference of ethical perspective on this which we simply have
Now, there are other people in the room who have already spoken,
who notwithstanding their worries about this are prepared to say
with you that we do lots of peculiar and aesthetically problematic
things in medicine, some of them even morally complicated, and that
doesn't necessarily rule them out, especially if the animal
research shows great human promise, and I think there's a way
of fixing this document to make sure that this particular kind of
— Michael reads that, and he says it's sort of devastating,
and it's partly devastating because the other side has not been
presented in that particular paragraph, and I think if Bill can
give us a response to that, that fills out this document and improves
I'm simply going to go to the queue.
DR. HURLBUT: May I —
CHAIRMAN KASS: No.
DR. HURLBUT: I'd like to withdraw my last comment
CHAIRMAN KASS: No.
DR. HURLBUT: May I withdraw my last comment?
Michael, I'm sorry. I didn't meant to imply you hadn't
read my statement, but I do think that I have serious arguments
that have not been discussed properly.
CHAIRMAN KASS: Okay. I have Janet, Gil, Rebecca and who
else has been hiding out? Frank and Alfonso, and I'd better
say something, too, at the end.
So, Janet, please.
DR. ROWLEY: All right. Well, I'd like to deal with
the issue raised on page 19 under the rubric of is it scientifically
sound because I think Charles and several others in the text of
this part of the document talk about teratomas.
Teratomas are chromosomally very abnormal, and that's not
what we're talking about here. So I think the analogy with
teratomas is potentially an unfortunate one because the ultimate
goal of this research, of all stem cell research or most of it,
is to think about ways that stem cells can be used to treat very
devastating human disease.
And the proposal here is going to take a nucleus before it is
introduced into an oocyte or an oocyte-like cell. It's going
to change, potentially change only one gene that then prevents that
cell from developing into an embryo, but the critical thing, as
pointed out on page 19, is that this has to be fully reversible
without residual abnormalities in the derived cell.
So you want to make the smallest possible genetic change to prevent
the cells from forming an embryo and a change which will be fully
reversible so that the cells that you finally give to a patient
to treat a disease are, in fact, functional cells.
Now, that's like saying that an embryo that has a defect,
say, in the disease of hemophilia, for example, the embryo has 29,999
genes, all normal human, all going to lead to a normal developing
human with brain function and things of that sort, but one gene
is abnormal. The proposal to work has to be that a single gene
that is essential for developing an embryo is disarmed, if you will,
before the nucleus is inserted into the oocyte, but then is fully
And I don't see how one can look on the developing cell with
essentially all normal genes except one as any different from an
embryo carrying a defect that leads to hemophilia, that leads to
muscular dystrophy or something else.
So it's a fully human embryo with one gene defect, and for
me that's the equivalent of a human embryo.
CHAIRMAN KASS: Let me continue in the queue. Gil and
PROF. MEILAENDER: As far as I can tell, everyone or almost
everyone agrees that the basic structure and analysis of this paper
is very good. I mean, everybody thinks it's well done.
And I've been trying to figure out sort of how to describe
what exactly it is that we're arguing about. I think in some
ways we're actually arguing about some old questions and not
about the question that's here.
I haven't heard any proponents of or any of those who are
favorable toward alternative three argue that it should for now
be done in human beings. I have not heard that.
I have not heard any of those who have reservations about it argue
that it would somehow be morally wrong to proceed to do it in animals,
though even if those studies proved to be promising, they might
still have the yuk factor and have a moral objection to proceeding
in human beings, but I haven't heard arguments that it shouldn't
be done in animals.
If that's right and, you know, subject to correction from
anybody who thinks differently, whether they're favorable or
unfavorable toward alternative three, it doesn't seem to me
that we have a deep disagreement. We may have a difference in tone
about how many exclamation marks we want behind the sentence that
says it would be fine to proceed with this in animals, but that's
about what it amounts to.
The only thing that would be disingenuous would be somehow to
say, while we normally say that science should attempt to proceed
on every ethically acceptable front, we know in advance that this
is not an ethically acceptable front. I mean, that, I think, would
be a mistake.
But if you say do the basic work in animals, see what happens
with however many exclamation marks we together want at the end
of the sentence, I don't think that we have a deep disagreement
So to me that's where it seems we are, and it doesn't
seem to me to be a bad place to find ourselves.
CHAIRMAN KASS: Why don't you hold off, Bill? Okay.
DR. HURLBUT: My one comment to Gil is I agree with you,
but I think that equally applies to all four proposals.
Until you are clear about what four is producing you certainly
can't say it's ready for human use, and in a way that's
true also of one. Until you're absolutely clear that the single
cell from an eight cell embryo is not totipotent, for example, you
can't say that you can go proceed with human use of this technique.
All four proposals, with maybe the exception of two, offer promising
prospects, but also are at the stage of being investigated.
CHAIRMAN KASS: I think I know how one could write such
a conclusion that makes it perfectly clear that these are provisional
findings of a preliminary hearing, and that this is not the end
of the ethical analysis or the ethical discussion. "On the
other hand. . . ."
There's a way to write this that begins from where Diana is
and where Gil is and takes into account your precautionary concern
that this ethical conversation, even about the ones that seem to
us relatively innocent, may turn out not to be so innocent on further
reflection, but that they pass a certain kind of minimal ethical
threshold to say these are things worth considering talking about,
and the Council is not just punting, having done this analysis.
I think there is a way to do this and find a kind of general acceptance
around the table, and I certainly welcome the chance to try to produce
such language, not here on the spot today, but in short order, and
the troops in the office know how to do this very well.
Rebecca, you've been very quiet.
PROF. DRESSER: Well, I don't have deep disagreement with
much of what I've heard. I don't have an objection to saying
it's permissible to go forward with these investigations in
I think we should acknowledge that science is always or often
very surprising, and it's not clear that any of these things
will develop to the point where people are seeing clinical applications.
If certainly three — and, of course, I share the concern
about two and the risk to any children who might be born from any
procedure — but for some of these others, especially three
because it requires eggs, if the science does go forward and prove
to be promising and then the question comes, well, should we try
these in humans, I think there will be very serious ethical considerations,
just as there will be and are with SCNT in the fact that you have
to use the human eggs.
So I would go along with the trend of your proposal in terms of
no ethical objections to looking at this in animals. There could
be some serious issues, depending on how the science turns out,
if the step toward humans occurs.
CHAIRMAN KASS: Thank you.
DR. GÓMEZ-LOBO: My apologies for coming in late
My overall inclination is to endorse the document. I find it
very good, very clear, and ultimately solid. But my main reason
for endorsing it is because, contrary to an E-mail circulated by
Michael Sandel, I don't think we're in a position of making
any definitive moral judgments, but I know that by now we have a
consensus on that.
Let me just mention this. Of course, there are questions of the
development of the science. If some of these proposals simply don't
work from a scientific point of view, of course, it's going
to be moot and, thank God, we're not going to have to worry
But we need time not only for the science, but also for the ethics
because I think that these are quite new ethical problems, and we
need time to consider externalities, if you will, or other aspects
that are not considered here.
Let me just give one example. I have very serious problems with
Proposal 2 because of the reasons just mentioned. It's a case
of battery really to go into the body of a human being and extract
But number one also has its problems because there are important
disanalogies between the practice of extraction of organs for transplantation,
say, after an accident and the circumstances of the waiting for
the death of an embryo in order to extract the organs.
I think that one can imagine several scenarios that would make
it morally very problematic. Up to now in transplantation ethics,
one of the key demands is that there be a drastic separation between
the physicians dealing with the person who has died and the team
of transplantation surgeons that move in to extract the organs,
whereas here we'd have practically the same team as if around
the deathbed of someone waiting for that embryo to die in order
to extract the cells.
Now, that's just one example which occurred to me is the kind
of problem that needs time. There may be others, or they may be
So basically, you know, I praise the document, and there may be
need to include some responses from Bill and then to modify the
CHAIRMAN KASS: Thank you.
PROF. FUKUYAMA: Well, I don't know. I guess I'm
not so sure I'm happy with the document just from listening
to this discussion today, and I'm not quite clear, Leon, what
you think the procedure from here is, that if we endorse the document,
you're just going to get some language from Bill to strengthen,
you know, his objections.
Because as I'm listening to this discussion, I'm even
more confused about what I think about this issue because there's
a huge difference between creating something that looks like a teratoma
and creating something like what Janet suggested, which is basically
a complete embryo with just a kind of minimal, you know, number
of genes changed.
And I would think that it's also something where the scientist
creating this entity could actually use some ethical guidance because
I presume that there's a certain, you know, range of variation
in exactly how many genes they could change that would make it look,
on the one hand, more like a teratoma and, on the other hand, more
like a real human being.
So I don't think it's simply enough to say, well, we can't
say anything more ethically about this until the science goes ahead
and, you know, does a proof of possibility study in animals. I'm
just not at all certain that we've really explored this whole
set of issues adequately.
Second, just a brief comment I'd like to make. I know this
is an ethics council, and we're not supposed to deal with politics
more broadly, but the political landscape on this really has changed
since we first started discussing stem cells at the beginning of
this Council because this proposal back then was a way to break
this logjam at the federal level where the funding was blocked.
Now we're in a very different landscape where it looks like,
I mean, first of all Proposition 71 has opened the floodgates to
stem cell research in a much more straightforward way. Every state
is reacting to that. The university that three of us, you know,
teach for is under big threat because all of the postdocs now are
going to be heading out to a university in California to get, you
know, some of this, and some of the senior researchers may be departing
Maryland as well.
And what we're heading towards is actually — Gil and
I were discussing this yesterday off line — but a kind of
blue state/red state federalism in which different types of scientific
research under different ethical guidelines are going to appear
in different parts of the country because of the blockage and the
inability to get a federal policy.
And so it's something to bear in mind that, you know, I'm
not quite sure who we think we're giving guidelines to because,
in fact, the nature of the political landscape in this country is
such that we're actually going to have about 50 different, you
know, state policies on this issue.
And it does weigh a little bit in the ethical considerations because
if you think that stem cell research in a much more straightforward
way is going to be lavishly funded on a state level, then this as
a solution, you know, Bill's proposal, number three, as a solution
to the blockage, you know, it becomes a little bit less salient
because there is really an alternative way to get to the same, you
know, body of scientific knowledge. You just have to move jurisdictions
a little bit.
CHAIRMAN KASS: Thank you. Peter, I think, and I will
have a comment, and then we'll take a break.
DR. LAWLER: In light of what Frank just said, it's
perfectly true, right, that every thing we're doing today presupposes
this. It would be a good thing if we could acquire embryonic stem
cells without destroying embryos. That would be an improvement
in our present situation.
CHAIRMAN KASS: Pluripotent, not embryonic.
DR. LAWLER: Sure.
CHAIRMAN KASS: Okay.
DR. LAWLER: Pluripotent. It would be better if we could
do that. That would be an improvement on our situation. For some,
that improvement would be merely prudential. You could get funding.
That may be becoming irrelevant. I admit that.
But it may be good simply because the moral division in the country,
which is tragic in a certain sense because there are well- intentioned
people on both sides, would come to an end. It might be a good
thing; I think it would be a good thing if there could be a technical
solution to our moral problem, and it's reasonable to hope there
could be a technical solution to our moral problem simply because
the moral problem exists, it would seem, at a certain level of technology.
So there's a reason to hope that technology will cause us
to be able to overcome or surpass this problem, but we also have
to admit, I think, that none of these four possibilities are anywhere
close to being acceptable at this point. It remains to be seen.
It remains to be proven, and from that point of view I agree with
many of the criticisms or reservations expressed about Bill's
I'm not so clear it should be treated differently finally
from number one and number four because I think they're fairly
problematic in different ways, too. So I would encourage further
research in one, three, and four, with the acknowledgement that
none of this has been proven useful in terms of overcoming the moral
problem we have now. I mean it really is, to repeat, a pretrial
investigation. I think one, three, and four do give us probable
cause and we should go forward.
CHAIRMAN KASS: You want a comment and then I'm going
to wind up.
DR. HURLBUT: I just want to make it clear I never proposed
making teratomas. Teratomas I drew as an example of how nature
produces an entity that is not in my mind a living being. I would
not as a physician have any problem doing a therapeutic preemption
of that process.
I just used it as an analogy. What we're talking about is
something that is more like an inner cell mass. Janet Rossant in
her comments to us said, and I quote, "Each cell has its own
course of action and will continue to divide and differentiate even
if isolated from other cells."
It should be possible with a small change that has a very dramatic
effect on the coordinated coherence of the integrated unity of the
process of its organization to preempt the organismal nature of
We do not know yet how pluripotent cells or embryonic stem cells
are actually formed. Is it just a matter of having the cytoplasm
in the cell and then just waiting until it grows like Janet Rossant
implies, that each cell has its own trajectory, or does it need
the perfect and synchronized interaction of the entire organism?
That's an empirical question, however, one that can go below
our argument about whether or when the embryo had moral status to
whether or not it is an organism at all.
It's the idea that is to get below our problem. This is a
transition time in the history of science. In the end of the 19th
Century, we overthrew a simplistic vitalism in favor of studying
biochemistry. It's a little harder for us to understand and
to intuitively grasp with our natural moral sentiments that developing
trajectories, too, can be separated off from the totality of the
But we will learn that in our era of developmental biology, if
we're going to go forward at all in developmental biology, we're
going to have to do the same thing they did in biochemistry, that
is, break the parts apart from the whole so that we're not violating
human dignity while we have a tool to study it all.
I admit that my proposal, as with all of the other proposals,
raises interesting and important questions. My proposal also offers
a tremendous breadth of flexibility and could provide much or most
or all of what the scientists hope and I hope we can proceed forward
It raises important questions. Our role as a Council, given to
us by the President, was to engage and educate the public. This
document does that in that it initiates an important conversation.
It was never intended to be a comprehensive analysis. If that were
true, we would be at fault for having done an inadequate job, never
hearing testimony, never really having a proper deliberation.
But, in fact, what we've done is we've produced an initial
cursory view that raised some questions like little red flags for
sure, as does all of SCNT, as does all of harvesting of IVF embryos
that are left over, all these things, but just saying that in the
deadlock of our country, the serious question could be perhaps solved
by a third option that we hadn't really thought through carefully
enough yet, and wouldn't that be instead of red state medicine
and blue state medicine, instead of people having to come into the
hospital 20 years from now and checking a box and saying, "I
don't want anything developed in California," wouldn't
it be better if we found a way to go forward in a coordinated, collaborative
research on a national level, funded by the NIH with proper peer
review, proper ethical overview? Wouldn't that truly be a triumph
If that's true, then it makes it worthwhile doing the hard
work that we have initiated in this Council that should be taking
place on a broader level in our society, the hard work of thinking
through these serious proposals.
CHAIRMAN KASS: I'll try to be brief. I think I concur
with — well, let me say this. I think we should try to find
a way that the conclusion does a little more than what it does in
this particular draft where it says some of us this and some of
us that, et cetera, but do so in a way that indicates the strict
preliminary character of these judgments, since there's a great
danger that what is going to be written in the conclusion, especially
in this town, will be treated as dictum, and everything else, the
analysis, just disappears, and it will look like the Council recommends
That I don't think we are exactly in a position to do for
the reasons that have been so both well expressed and well reflected
in the comments. I think there is a way to go partly from this
second memorandum to the Council, to introduce certain kinds of
greater ethical cautions about the proposals that we think pass
the minimum test, to revise the way in which the discussion of the
biological artifacts — when you indicate that there are these
serious concerns, but to adopt something like Diana's approach
so that what's written at the end really reflects the diversity
of opinion here, the tentative character of the opinion here.
I think no one has answered Gil's challenge. No one here
has really said that Bill's proposal should not now be investigated
in animals, that we think that there's an ethical bar to doing
that, which was all that that proposal was in the beginning.
And I think if the Council is willing to trust me and the staff
to produce a revision of the conclusion for your consideration,
we could do the rest of this by mail. Is that an agreeable thing?
And of course, line edits and things of that sort are welcome,
but we had better have them soon.
PROF. FUKUYAMA: Okay, but then do we just drop the subject
after that? What happens subsequently?
CHAIRMAN KASS: Well, it seems to me let us undertake —
let's step back from what we've done here, think about it
a while and see where one wants to go next on this matter.
None of these individual proposals may pan out. Landry and Zucker,
by the way, have submitted their proposal for IRB approval at Columbia
and they are, I think, planning to go ahead with this. I know that
Bill is in collaboration with some scientists who meet already to
try to do some of his work in animals.
And to my astonishment, the various kinds of findings of these
multipotent cells now in multiple places has just not gotten the
kind of attention that I think it deserves simply from a scientific
point of view to try to understand why is it so easy to find these
multipotent cells in bone marrow, in addition to the mesenchymal
cells, in addition to the hemopoietic cells, and what do they mean?
But the interesting thing is, in fact, to suggest that there really
might be room for creative thinking, that these proposals might,
indeed, stimulate other ones, and no one is saying that we're
not going to continue to perhaps have our disagreements about embryonic
stem cell research. There will continue to be political battles
over it, I'm sure, in this session of Congress. The states
will do as they will.
Some of them will produce bans and other ones will, you know,
produce a windfall, and that's the way we are, but we do have
an audience here. We have monitored stem cell research. Here is
something that contributes to that discussion, and I think we do
a service if we put out this document suitably concluded, suitably
corrected, and then think further down the road what would come
Let's take a break. We're 20 minutes over, but I think
it was important that everybody get their views expressed.
Could we make this break short? I know people have to leave early.
Let's come back in 12 minutes or so, and we have a session on
(Whereupon, the foregoing matter went off the record at 10:20
a.m. and went back on the record at 10:34 a.m.)