Thursday, January 15, 2004
Session 2: Biotechnology and Public
Staff Working Paper, "U.S.
Public Policy and the Biotechnologies that Touch the Beginnings
of Human Life: Draft Recommendations, Revised"
CHAIRMAN KASS: Thank you. Welcome to Janet Rowley.
We are expecting Mike Gazzaniga and Charles Krauthammer, who
are both in transit. This is the second session on biotechnology
and public policy, and is devoted to a discussion of the staff
working paper, entitled, "U.S. Public Policy and the
Biotechnologies That Touch the Beginnings of Human Life:
Draft Recommendations, Revised."
I think council members don't need much by way of rehearsal
of what this project is, or what we are doing, and why. Suffice
it to say that we have for some time, really from the very
first meeting, been interested in the monitoring and regulatory
institutions that concern the uses of biotechnology in general,
and that we focus that interest on the technologies touching
the beginnings of human life where already established technologies
of assisted reproduction now become joined with possible new
developments growing out of genomic knowledge, and the availability
of embryos for research.
We are on our way toward a report on this subject, the bulk
of which will be a diagnostic section of some length reviewing
where things now stand.
A brief section already has been discussed and basically
approved on policy options, both general and particular, and
a last section which we discussed both in September and in
October on interim recommendations, recommendations for the
time being while the Council and the Nation continue to deliberate
about what if anything needs to be done to improve the way
in which we now oversee, and monitor, and regulate these activities.
We in September had a discussion of the first draft of these recommendations,
and it was a very spirited and somewhat woolly conversation. We
returned in October, where we made I think considerable progress
A number of things were clarified, and a number of issues
in which it looked like we could find no agreement, and we
managed to produce a kind of agreement amongst us.
And the document has been changed extensively to reflect
those conversations amongst ourselves with a number of things
being removed that were contentious, and other things being
I will say, and I think that I would like to put in the
record that this latest draft also reflects changes that we
have made in response to comments by various stakeholders,
including patient groups and professional societies.
We have met with the — we already met the last time with
the President and the Executive Director of the American Society
for Reproductive Medicine. We have since met with representatives
from RESOLVE, and from the American Infertility Association.
And I want to go through a few of the changes that have
been made, because I would also like to say that to some extent
the concerns of some of these groups have originated from
at least a partial misunderstanding both as to the substance
of our document, and our intentions.
Nevertheless, they have offered some very helpful comments,
calling our attention to ambiguities or to problems that we
might be causing of which we were not aware.
And we have responded in great detail to some of their concerns,
and so that Council members don't have to sit with the last
draft and the current draft, let me just highlight a few of
these concerns, and put on the record some of the things that
we have changed.
First of all, there has been a concern that some of the
monitoring activities that we were calling for would produce
government intrusion and stigmatization. That we were calling
for measures that would involve undue intrusion of government
into the domain of ART.
That we would lead infertile patients and their children
to be stigmatized by being monitored and registered, and that
there was a concern that the studies that we were calling
for might imply mandatory participation and create a de facto
registry of children born with ART, though that was not our
We have modified the document to expressly state that participation
in all Federally- funded studies should be fully voluntary
as we had all along intended. We removed the recommendation
that the ART children be tracked through the first year following
their birth, thus avoiding the inadvertent creation of a mandatory
government registry of such children.
We have modified the document to note that the vast majority
of our recommendations requesting additional information calls
in fact for the publication of data that is already being
collected by the CDC under the Wyden Act, but not made public.
And we have eliminated from this document our recommendation
relating to the tracking of in vitro embryos produced during
ART. There has been some concern about sowing alarm and confusion
about some of the terms having to do with the way that the
data is reported, and the reporting of costs.
And I won't bore you with the details, but we have put in
suitable modifying language to address those concerns. A
major concern was that our recommendations might lead to restrictions
on access to assisted reproductive technologies, and the reasons
that were given included the following.
That the recommendations for increasing reporting and monitoring
might give rise to increased costs, which would then be passed
on to patients due to this requirement of increased oversight.
That people sensed that there were certain restrictions
that we were recommending on the use of embryos in clinical
and research contexts; and third, that there were restrictions
on certain practices that were integral to ART, such as gamete
and embryo donations, surrogacy and the like.
Partly, this, I think, rested on misunderstanding, and partly
there were important issues to be discussed, and the new draft
makes it expressly clear that our recommendation to increase
the CDC's funding is aimed precisely at shifting the costs
of any new oversight activities to the government rather than
to the patients.
The draft makes it very clear that we are not calling for
in vitro embryos as such to be treated as patients or human
subjects of research, and the language that led some people
to think otherwise, such as "child to be," or "future
child," has been replaced with "children later born."
The concern throughout is to make sure that we safeguard
the health and well- being of the children who are born as
a result of these procedures, and that was always the intent.
If the language was confusing, that has now been eliminated,
and the new version makes it clear that we are not calling
for any kind of ban on gamete or embryo donation, surrogacy,
the reimbursement for reasonable expenses incurred in the
course of such practices, et cetera, et cetera.
So I think that we are very glad that these concerns have
been called to our attention, even in places where we think
they rested on some partial misunderstanding, and I would
like to think that the new version of the recommendations
addresses the concerns of the stakeholders, as well as the
concerns of the Council members.
The goal for today is I think simple. We were very close
I think to an agreement on most of the things that are here.
The recommendations in the interim recommendations are in
three parts: (1) Recommendations for Federal studies, data
collection, reporting and monitoring, regarding the uses and
effects of these technologies; (2) recommendations for professional — for increased oversight by the professional societies
and practitioners; and (3) recommendations for targeted legislative
measures to defend the dignity of human procreation. Those
are the three sections. And my goal today, and I think we
should be able to achieve it, is to try to reach the agreement
on the gist of these provisions, leaving the line editing
and refinements for later.
The rest of the document has been reedited, and will be
sent to you shortly with a revised version of what we are
talking about today, so that you will fairly soon be able
to see the whole thing.
Given where we were on the stem cell report, and we didn't
feel it was appropriate to burden you at this time with yet
another hundred pages of document to be read carefully. So
that is coming next.
Any questions or comments on my opening remarks or on the
procedure? Frank, are you — you looked like you were on
your way to say something? No?
PROF. FUKUYAMA: I have several things to say,
but not now.
CHAIRMAN KASS: Okay. A note has been passed to
me, and I might as well read it, that Jim Wilson, who is unable
to be here, did send in a note saying that he endorses this
document as written. So that is at least in the record and
on the discussion.
Shall we begin and go section by section, and not necessarily
article by article, and see whether people have comments in
the large, first of all, about the particular items recommended.
And Janet Rowley, please.
DR. ROWLEY: I was not able to be here at the October
meeting, but I did raise a point that I think is very important
in the September meeting, that I don't believe is really addressed
by the draft that we have currently.
I think it is very important that we recognize that the
problems that we are facing, that this draft is trying to
correct if you will, are due to two factors.
One is the Congressional prohibition against funding any
research related to embryos. So there is much of the text
that relates to the fact that the procedures, and changes
in procedures, are often not as carefully documented as they
would be in other kind of medical procedures, and it is strictly
a result of the lack of appropriate and adequate funding.
So all of the research that is done is paid for by fees
from patients to various clinics. So this should be part
of the preamble; that Congress has really forced many of these
problems because of its prohibition.
The second problem that arises is that from the standpoint
of patients this procedure is not covered by health insurance.
As a consequence some of the other aspects that we are concerned
about, such as multiple pregnancies, which do not happen in
other countries where they have appropriate funding of patient
care, do happen here because the clinics are — if you want
to have a successful pregnancy, you put in multiple embryos,
and this is recognized as a less than ideal medical procedure.
But it is strictly a result in this country of the way that
we fund or do not fund health care for this particular medical
CHAIRMAN KASS: Any comment to that?
PROF. MEILAENDER: A question, just a question.
CHAIRMAN KASS: Gil.
PROF. MEILAENDER: Congress doesn't forbid all
research on embryos does it? It forbids research that involves
destruction of embryos by Federal funding of such research.
Am I not right about that?
We don't have any law forbidding research on embryos. We
have law prohibiting Federal funding of research that destroys
CHAIRMAN KASS: I think Janet's point would be something
like this. That attached to funding is very often the obligation
for a certain kind of review, and that in the absence of a
funding policy the government has lost — in Janet's view,
has lost something of its leverage to actually regulate the
And I don't think she was saying that this is outlawed,
that the activity itself is outlawed.
DR. ROWLEY: Well, it's in — I stand to be corrected
by people who are more conversant with the specific details
of the law. But any sort of research trying to see whether
Procedure A is more likely to give you viable embryos or viable
embryos of higher quality, is inevitably going to lead to
some of those embryos dying.
And that's because you are trying to see what you can do
to improve it. So I think that it is unrealistic to think
that you can fund research on embryos that is focused on trying
to improve conditions without as a necessary component of
that being some research that would lead to the death of embryos.
And science is about comparing things.
CHAIRMAN KASS: Robby.
PROF. GEORGE: Janet, I just wanted to ask a
question of clarification about your comment. There were
two parts to it. The first had to do with what you take to
be the implications of the prohibition on Federal funding
of embryo research or research that involves the destruction
But as I understood your second comment, and this is what
I wanted to be clear about, your second comment doesn't have
to do with that?
DR. ROWLEY: No.
PROF. GEORGE: Your second comment is a more
general criticism of the health care system in the United
States, comparing it unfavorably, say, with the European systems.
That wouldn't have anything to do with whether embryo research
is funded or not funded.
You are just saying that if we had a better and superior
health care system overall that we would be relieved of such
problems, which I would agree are very serious problems of,
for example, multiple pregnancies, and the practice of implanting
multiple embryos, with a view to having at least one survive
and so forth.
Just have I understood you correctly? I am not here arguing
DR. ROWLEY: Right. No, I think that is correct,
and what I am saying is that these two factors play a central
role in the problems that we are now trying to fix, but we
are fixing it around the perimeter, and we are not dealing
at all with some of the fundamental causes that lead to some
of the concerns that members have.
And I think not to state this right up front is in my view
a major deficiency of this particular document.
CHAIRMAN KASS: Let me offer a comment in my own
name, Janet. I think — I take your point, and I wouldn't
deny the relevance of both of those considerations to the
situation that we have.
But I think on the first point that when similar comments
were raised in the past, there were responses to say that
there are all kinds of things that the government can and
does regulate that it doesn't fund.
And indeed the Wyden Act to require the reporting is an
Act that Congress was able to enact, even though it could
not get past funding for the embryo research itself.
So it makes it more difficult, I grant, but the Government
regulates lots of activities that it doesn't fund, and therefore
one cannot simply say that the reason that this is an unregulated
area is solely due or primarily due to that.
It is a factor, but I wouldn't share your interpretation
that that is the cause. And second even on the question of
health insurance, the profession has in fact tried very hard
to set guidelines to reduce the number of embryos that are
There is professional self- regulation, and we are in effect
calling on the profession to do more of that. You don't need
a national health insurance to practice responsible medicine,
and it might help to remove certain kinds of financial disincentives
to practice responsible medicine.
But again I wouldn't say that that is the sole explanation
for what we have here. I am very happy to include the points
in the analysis, but I am not sure that I would include them
as determinatative, (a), and (b) in the recommendations, you
will recall that we are trying to look for those things that
we can recommend, notwithstanding certain kinds of unbridgeable
differences amongst us.
DR. ROWLEY: But I would like to come back to this,
because I think that we have agreed that the government requires
things that they don't fund, but I think so much of the text
is that the technologies that are being used are experimental,
and new technologies are put into place that are in one sense
And to decry that, and then to say that you can't put new
technologies into place without having them thoughtfully and
carefully evaluated, but we won't fund any of that evaluation
on a larger scale, I think this puts us in the hypocritical
state, which I suspect we would prefer not to be.
The second thing is that there is a great emphasis here
on making — and coming to my second point, making information
available to patients about the success rate of clinics.
And to the extent that we tell clinics that it is important
to use fewer embryos, their failure rate is going to go up.
This is going to reflect in the statistics.
So the more responsible clinics that use fewer embryos will
look worse in just the kinds of statistics that we are collecting.
And again I think that we have to recognize the forces that
are driving all of this, and I think not to be honest about
the forces is to undermine some of what we are trying to do.
CHAIRMAN KASS: Mary Ann.
PROF. GLENDON: Yes. We are in the preamble,
I gather, and the preamble states, or the introduction states
that it would be premature at best to recommend dramatic legal
or institutional changes.
Since a reference has been made to what is done in other
countries and countries specifically with national health
insurance, I thought that it would be interesting just to
notice that I am reading from a January 11, 2004 summary of
recent European legislation on this topic.
Many of these countries prohibit the freezing of embryos,
limit a couple to 2 or 3 embryos, and some countries prohibit
donations from third- parties, limit in vitro fertilization
to heterosexual couples; prohibit genetic testing on embryos;
proscribe cloning or experimentation on embryos.
And so it is worth noting that there are a number of countries
that do not think it is premature to take more extensive measures
than the very modest ones that have been recommended in our
CHAIRMAN KASS: Frank.
PROF. FUKUYAMA: I guess, Janet, I don't understand
the objection, because the FDA regulates drugs. You know,
requires extremely expensive clinical trials that drive up
the price of drugs, but the Federal government does not fund
the development of — I mean, it may in some cases fund the
development of new drugs, but it does not — you know, you
don't question the legitimacy of its regulation of private
sector activities in drug development simply on the grounds
of the level of funding, Federal funding, for drug development.
So I don't really understand the two are necessarily related.
I mean, if there are serious safety considerations that are
raised by private sector activities in this area, it seems
to me that the Federal Government would have an interest in
looking at that, regardless of whether it funds these activities
DR. ROWLEY: But, Frank — I mean — I don't think
that is really relevant, because the drug companies after
all are able to incorporate the cost of drug development in
the cost of the drugs, and I am not aware that any drug company
is on the street bankrupt at this point.
So I think that we are talking about activities which — the research for which is funded by patients out of their
discretionary funds, and I think it is a totally different
DR. FOSTER: I was going to say the same thing.
In principle, what you say is correct. But corporations have
big funds for research. You pay for it in the drug, but none
of these people — I mean, it is a very expensive thing to
have in vitro fertilization, but nobody is getting rich out
I mean, if you just look at the incomes, and the doctor's
incomes and the nurses, and so forth, which are there, there
are no — as far as I know, there is nobody getting or has
any excess surplus funds that you could do expensive laboratory
or other research.
So I think that — I agree with Janet that that doesn't — that this is one of the rare times which I think that
your comment doesn't apply, okay?
CHAIRMAN KASS: Frank.
PROF. FUKUYAMA: I mean, Congress just passed
one of the biggest new entitlement bills for drug benefits
precisely because the requirement for drug testing has driven
up the cost of pre- drug development up in this country and
people cannot afford it.
So I just don't see in principle — I mean, it is true
that the structure of the ART industry is very different from
that of the pharmaceutical industry, but part of the reason
that you got this structure of gigantic corporations is precisely
because of the regulatory burden that is placed on drug development
by the FDA.
So, yeah, you are absolutely right. It is going to drive
up — I mean, some of these things are going to drive up
the cost of these kinds of treatments, and they will have
to be borne out of the pockets of the people that want the
But again I just don't see how this is any different from
private sector drug development.
DR. FOSTER: I do want to say also without being — I love the drug companies. They are making wonderful
new drugs, but I don't have the latest figures, but I believe
the evidence is pretty overwhelming that they spent more money
on advertising and doctors in luxurious parties than they
do on research and development.
So, I mean, I think that is a very — it is not fair to
say that the cost of the drugs are solely because of regulation
for safety on the FDA. I mean, if you look at these budgets,
I mean, they are obscene about some of the things that are
done at scientific meetings and so forth.
I mean, that is probably irrelevant, but I had to say that
because it gets my spleen up; that when everybody says that
because of the drugs the FDA is the cause of this. I think
we ought to be very thankful that we have an FDA that is trying
to carefully look over these drugs, and particularly the second
level drugs and so forth that go on.
I happened to hear the Commissioner talk this week at this
meeting in Texas, and he points out and defends even the approval
of second — you know, "me- too" drugs, and drives
the costs down, and so it probably — you know, I don't know
much about the FDA, but I think that we shouldn't blame them
for these costs exclusively.
PROF. GEORGE: Dan, you have whetted my appetite.
What are these obscene things that happen at scientific meetings?
CHAIRMAN KASS: No, let's —
DR. FOSTER: I should not use that term. The obscenity
is gluttony of food and drink, that's all, and nothing to
do with anything immoral, okay? Please do not saddle me with
CHAIRMAN KASS: Let me try to resolve this. We will
certainly take Janet's comments into account in the new draft.
One word on the costs, and the cost was an issue already raised,
and we have indicated at least with respect to the call for
additional Federal activity that the funds ought to be provided
as they are now provided to the CDC for any additional activity
that the CDC would undertake.
So that this would be an attempt not to pass those costs
on, or at least that is our — we are cognizant of that fact.
Let's go from the preamble actually to the particular recommendations
and in Section 1.
Welcome to Mike Gazzaniga, who is happily down here where
the temperature is only 30 degrees instead of minus 30. Oh,
and Charles, welcome to Charles Krauthammer. Sorry.
Section 1, beginning on page 3, we are just beginning to
review the particular recommendations on the Federal studies.
And since we could go one by one, but let me — and since
I think that this is relatively okay, why don't I simply put
the whole of the materials from page 3 through page 10; the
Federally- funded longitudinal study on the health and development
implications of ARTs on children.
And we have had very good conversations with the people
designing the National Children's Study, and we are hopeful
that they will be willing to include this as part of their
To undertake Federally- funded studies on the impacts of
ARTs on women, on the uses and effects of reproductive genetic
technologies; strengthen and augment the Fertility Clinic
Success Rate and Certification Act with specific provisions
on reporting requirements.
And on enhancing patient protection and implementation.
These have been streamlined and changed in ways that I already
indicated. Are there questions or comments on any of these
particular items? Gil.
PROF. MEILAENDER: My comment is with respect
to something on pages 6 and 7. It is under the enhanced reporting
requirements, (b) I guess it is, risks and side effects.
I would like to see us restore a sentence that was in an
earlier draft, but is not there any longer. I don't know
whether the rest of you will think it is worth it. But I
preface this by saying that sometimes when you bend over backwards
to be accommodating, you simply get kicked.
And that seems to me to be happening here. I mean, we have
before us a news release from RESOLVE about what we are supposedly
doing today that is inaccurate in almost every respect.
And this was one of the stakeholders that we were worried
about. What I would like to see us do is add at the end of
that paragraph that goes over on to page 7 a sentence that
simply says this is taken from the previous draft. ART clinics
should be asked to provide data on the incidents of adverse
effects on women undergoing treatment, as well as on the health
and development of children born using ART at least through
the first year of life.
I myself don't understand why anyone wouldn't think that
was useful information, and that one would like to know.
Remember that all we are doing is asking for information to
be gathered that might be helpful in determining what regulation,
if any, would be needed or wise to advise.
It seems to me that this sort of information would clearly
be useful, and would be worth knowing. I don't understand
why it dropped out, and I myself would like to see it restored.
CHAIRMAN KASS: Carter, I may need some help on this,
but I think I can understand why it is absent. First of all
the clinics do not follow these children once pregnancy has
begun. They are turned over to the obstetricians, and then
to the pediatricians.
Second, in order to do that, you would have to have a de
facto registry of children born with ART, and there is a great
deal of interest both in the patient groups and in the practitioners,
to protect the privacy of the participants.
We thought that we might in fact get the kind of information we
were interested in from a longitudinal study in which people are
tracked not just through the first year of life, but as long as
the study continues, and tracked prospectively such that one would
simply happen to know that some of the children in the study had
And that all of the participants would be volunteers, and
we would get the information without having to violate these
particularly important principles and concerns, both of the
patient groups and of the practitioners. Carter, have I got
MR. SNEAD: Yes, I think that is a fair characterization.
CHAIRMAN KASS: Carter Snead, who is our general
counsel, has been the major — in fact, Carter, why don't
you take a seat here, because we might need you in addition.
MR. SNEAD: Yes, Leon, I think those were — that
was a fair characterization of the concerns that were raised,
both the logistical difficulties of gathering that information,
and requiring coordination with pediatricians and so forth.
There is not right now a continuity between the doctors that — you know, the reproductive endocrinologists, the obstetricians,
and then later, pediatricians, that would have to be created.
And then secondly there were concerns about stigmatization
of these children through the creation of a de facto registry
as you outlined. I think that is a fair characterization.
We thought that we would get the same sort of information
through the longitudinal study.
And then additionally — and one thing to add about the
longitudinal study. The National Children's Study, if they
were to accept our offer to include this information in their
project that they are going forward with, they release their
data at certain milestones, such that you wouldn't have to
wait for 21 years to get the relevant information.
And so there would be sort of a rolling reporting of the
results that they would get. So basically to accommodate
the concerns that were raised, and with the idea that the
same information could be gathered through other mechanisms,
that's why the document was changed the way that it was.
CHAIRMAN KASS: Other comments about these original
- - Gil, do you want to —
PROF. MEILAENDER: I would just put on the record
that that does not seem to me to be a sufficiently weighty
reason to eliminate it. It does seem to me to be information
that would be useful to have.
I think the registry language is bogus, and there are plenty
of ways to protect confidentiality in our world. And I can't
see much hope for any future regulatory agency keeping close
watch on these matters.
If a body like ours that simply is thinking about what information
it might be useful to have in order to know whether there
should be such an agency, or what it might regulate, already
goes belly up at the first sign of pressure.
So it seems to me that it is useful information and that
it would be good to have.
CHAIRMAN KASS: On this very point, Robby.
PROF. GEORGE: Yes, I wonder if the staff has
looked into it, or if Mary Ann just happens to know, how other
jurisdictions — European countries, Japan — have dealt
with trying to honor both of these concerns, the one that
Gil quite legitimately raises, and the concern about privacy
and so forth.
Perhaps there are models that would be helpful to us. Do
MR. SNEAD: As far as the jurisdictions that have
the most comprehensive approaches to monitoring and oversight
of these reproductive technologies, my recollection is, if
it is correct, is that there is no jurisdiction that provides
for oversight up to a certain — beyond the stage of birth.
So as far as I know, there are no models that would provide
useful examples for how to solve the logistical problems of
tracking these children and their families.
And most of the registries that are being created abroad,
my understanding is that in France and maybe in Belgium, there
are sort of Federally- sponsored efforts to track these individuals,
and I would have to look more closely at how they go about
PROF. GEORGE: Do you know anything about whether
privacy concerns have been taken into account?
MR. SNEAD: I imagine that they have been. I met
with our counterparts at the HFEA in Britain in August, and
that seemed to be a concern that was very — that was foremost
in their minds was safeguarding privacy.
So I think that they had done that in a way that is satisfactory.
I can't speak to the specific mechanisms that they used though.
PROF. GEORGE: Well, I would like to request
that the staff look into this and perhaps we can satisfy everyone
CHAIRMAN KASS: Okay. Still on this same point,
or are we going somewhere else? Is it on the issue that we
were just discussing? Mary Ann, is it still on this point?
PROF. GLENDON: Yes.
CHAIRMAN KASS: Please.
PROF. GLENDON: I just think it is worth emphasizing
how modest the recommendations in this section are. Nobody
is talking about government regulation of a practically unregulated
industry. One is only talking about information so that there
can be informed public deliberation of some of these issues,
the kind of deliberation that we have in a democracy.
I think that I am just a little skeptical about talk about
undue government intrusion, or privacy concerns, when all
that is being sought here is information and letting the sun
shine into an industry that apparently is bent on keeping
its activities from public surveillance.
CHAIRMAN KASS: Comments still on this? Mike, do
you want to go somewhere else?
DR. GAZZANIGA: Well, it is related.
CHAIRMAN KASS: Please.
DR. GAZZANIGA: I am continuing to read this section
and to be able to think about it, and it really comes down
to what we are saying, is that we are trying to recommend
that epidemiological studies be carried out in IVF. Why don't
we just say that?
Federally- funded, and we would recommend that Federally-
funded epidemiological studies be carried out on IVF, period,
and not try to play the game of what all that means.
There are epidemiologists who know how to do this, and they
do it all the time, and for us to try to prescribe these various
this and thats is probably not necessary, and I don't even
know that it is particularly informed by the subtle science
So — I mean, what the intention is, is simply to carry
out that sort of activity, but let the sun shine in as Mary
Ann says, and there are procedures for — well- established
procedures for doing that, and I recommend that we just recommend
CHAIRMAN KASS: Rebecca.
PROF. DRESSER: Well, I think we are writing
this document not just for researchers, and so I think it
is worthwhile talking about what the kind of information is
that we would like to see to the ordinary person.
I mean, if you just say do epidemiological studies, the
ordinary person won't be able to understand that, and I guess
I want to second the consumer protection value of this information.
This kind of study would enable people who have children
this way to know if there are certain medical problems that
crop up more often, so that the pediatrician needs to be looking
This really could promote the health of these children,
and so it seems to me that consumer groups should welcome
a call to produce more of this information just so that their
constituencies can make better informed decisions, and they
are usually people who are very concerned about the well-
being of their children.
And this kind of information would enhance that ability
to show concern for their children.
CHAIRMAN KASS: Janet.
DR. ROWLEY: Well, I noticed that Kathy Hudson is
here, and I wonder with regard to the question of what other
countries do, because I am under the impression that they
are some large studies in this matter, whether Kathy could
answer or has any information, or —
CHAIRMAN KASS: Kathy, would you like to respond,
if you wish.
DR. HUDSON: With respect to the question of post-
birth surveillance of health of ART children, in other countries
I think the situation is quite different, where there are
national health records in many countries, and national birth
records in many countries, that can be linked.
So you can do studies, albeit retrospectively, of large
cohorts of children because of the existence of these records.
So I think where we see the best data is in fact in countries
where you have that kind of record system, which of course
we don't have in the United States. Was there another —
DR. ROWLEY: Well, the question is whether there
are any results or whether these studies have a time in which
they are going to do the analysis and publish them?
DR. HUDSON: The European Society of Human Reproduction
and Embryology has been doing a very large prospective trial
looking at children's health from ART.
And they are now following kids up to about seven. I think
they have reported data on the health of children out to about
seven. I think the existence of that data doesn't negate
the need for additional research in the United States, because
techniques do vary.
DR. ROWLEY: Thank you.
CHAIRMAN KASS: Thank you very much. Dan.
DR. FOSTER: Michael, I thought that it was very
attractive from this standpoint to try to bond in on the study
that is going to already be done. I mean, that you are going
to follow these, and so it seems to me that the modesty of
this is also very practical, and the information that we really
want to know would come out, and particularly since they are
going to have interim reports.
I mean, just look at the Framingham Study and things like
that. I mean, we really need to know whether if you take
a cell out for genetic diagnosis and so forth whether that
does anything or not.
I think that everybody would want to know that, and so I
was really quite enthusiastic about not coming up with some — to say somebody else to do an epidemiologic study, and
let's say an agency such as the CDC or something.
I like the idea of trying to just add on — because it
is a monumental thing to follow a hundred- thousand kids.
I mean, you know, people drop out of these things all the
time, and so I thought that this was a great idea myself.
DR. GAZZANIGA: Well, let me just comment on that.
I have no problem that the epidemiological analysis goes on
within that study. That study as you know has not been funded.
And they are looking to tack this on to try to get it funded
and there are inherent problems with these studies because
of the drop out and because you start to dilute the number
of factors that you are looking at, and then you can't really
say statistically about any of them, et cetera, et cetera,
So I think that it is fine in the sense — I mean, in the
sense that it sounds right, but in some sense just to recommend
funding of IVF might allow it to go forward when maybe that
mammoth thing won't go forward.
So you might get locked up in getting what you want to get
done here by completely attaching it to that study. That
is just a very practical point. But that is what we are talking
We are talking about getting it done somehow, and I think
just saying it is sufficient. I mean, then we don't have
to get entangled in all these subtleties.
DR. FOSTER: Well, I heard what you just said about
maybe this would enhance, but maybe the sentence that one
would add here would be something like that should there be
a failure of funding of the child health study or whatever
it is called that we would recommend an independent study
of the children be funded because this is such a critical
issue. Maybe just a sentence like that added would be helpful.
CHAIRMAN KASS: Also, let me just say quickly, Mike,
that one could preface this with the generic comment that
you make, but the particular things that have here been identified
are in fact and do grow out of the analysis that we haven't
recirculated at this time.
But that we have identified different kinds of areas for
an epidemiological study, and we have also talked about the
already existing reporting requirements and suggested that
there might be some additional things that could be done to
augment the publication of data already collected.
So I do think since there are various possible target audiences
for this that there is a certain amount of specificity is,
I think, helpful. But I am prepared to — well, these are
the kinds of information that we are somehow specifying here.
If we are going on too long about it,and you think it could
be streamlined, we could certainly do that. Anything on the
particular concrete substantive things in that first section?
DR. ROWLEY: As a point of information, Carter, I
have been told by individuals with whom I have been discussing
this matter that there is in fact a Federal website that is
devoted to information about ART, and it is my impression
that this is the only Federally funded site on any medical
MR. SNEAD: I think what you are referring to, and
you can correct me if I am wrong, is the CDC's ART surveillance
website, which — is a web publication of the document that
also comes out in hard copy that is basically required by
the Wyden Act, to outline the success rates and various points
of analysis. Is that what you are referring to?
DR. ROWLEY: I assume so, since this is information
that I have gotten from discussions with others. We didn't
go into great detail about this.
MR. SNEAD: Right.
DR. ROWLEY: But it is pointed out that there is
no other Federally- funded website about any medical procedure.
MR. SNEAD: That's interesting. I was not aware
of that, that there were no other Federally- funded websites.
I know that the CDC has other websites relating to other medical
concerns, but I don't know how that bears on your comment.
But that would be news to me if that were the only Federally
funded website that relates to a particular procedure.
CHAIRMAN KASS: Shall we proceed to the second section?
PROF. GEORGE: One more, Leon, on that question
of the possibility of tracking the numbers of embryos that
are created, their use and disposition. My impression is
that it is actually very difficult to get reliable information
about just the sheer numbers of embryos that are created in
the industry, and how they are used, and their final disposition.
If that is true, is there any proposal short of the one
that was in the original draft for enabling that to be done?
Or if we don't propose anything here, will it just be continued
ignorance about the facts?
CHAIRMAN KASS: We made a decision simply to remove
that section. There has recently been a study, the RAND study,
which has disclosed the numbers. It would be possible to
make a request to produce aggregated data from the various
clinics without identifying which clinics.
I mean, the clinics are rightly concerned that publication
of such data with their names attached to it would in fact
enter into the political turmoil about abortion politics and
the like, and they want to protect the privacy of what they
There is a case to be made that the Nation as a whole might like
to know the answer to just simply the quantitative data. But we
recently had a study which, to the best of people's knowledge, indicated
there were roughly 400,000 embryos in cryopreservation.
And I guess the question is what difference would it make
if we commissioned a study which produced the number of 600,000,
or 300,000, or 1 million.
It seems to me the number — we know that there are lots,
and since this is not — since we don't have a policy here
to recommend on what should be done there, it seemed to be
to call for that kind of data collection at this point, knowing
that the number is very large already, seemed gratuitous,
and off the main point.
If there is strong feeling that this should be restored, I am
not unhappy to restore it, but it didn't seem to me to be essential
to what we were talking about here.
PROF. GEORGE: Well, if we could get the information
another way, I would be very open to that, but I think that
the information is potentially relevant to public policy mix
and the kinds of people that we are attempting to serve.
I think it is. I mean, as we go forward just being able
to compare what goes on here with what goes on in other jurisdictions
that have other sorts of regulatory schemes or have regulatory
schemes at all, I think would be potentially at least very
CHAIRMAN KASS: It certainly would not hurt anybody
to know the answer. But let me simply ask, is there anybody
who would object if there were simply a restoration of some
kind of request for information on the number of embryos created
Do we regard that as an important piece of information that
people want to know in this area or not? Yes, no, maybe?
How many think that this is information worthy to be had and
that we should restore something on this?
(A show of hands.)
CHAIRMAN KASS: How many think otherwise?
(A show of hands.)
CHAIRMAN KASS: We will think about it. I mean,
there was a certain — and we will talk to the individuals,
but there was a certain sense that these recommendations were
to be as much as possible the recommendations that were rested
on those things about which we could agree, and part of the
thing is to show that people have differences of opinion on
some of these matters, and find a basis nevertheless to speak
in common on things that are dear to us.
I won't discuss — I think we have noted the people who
have reservations about this. We will pursue that, and if — and we will reach some resolution on that, and you will
be informed rather than try to fight it out here. Is that
DR. ROWLEY: It is not on this point, but it is on
page 8 and 9. Are we still on those pages?
CHAIRMAN KASS: Fine. Yes, we are still in this
section. I am going to try to budget our time to make sure
that we don't lose out on the sections that might take us
longer than this. But, please, Janet.
DR. ROWLEY: Well, again, in discussions with people
more knowledgeable than I, it has been pointed out for Section
E, the adjunct technologies, and our concern about ICSI, that
in fact about 5 percent of apparently normal sperm failed
to fertilize an oocyte.
And at least right now, given the fact that there is no
funding to understand these problems, we can't — I mean,
the individuals involved in this can't distinguish the normal
from those that have various other things that can be identified.
So, you see, we have talked here and commented about the
fact that ICSI is used in individuals, even those who do not
suffer from male infertility factor, and again with the pressure
to have positive results, both from the standpoint of patients
for whom this is a painful — or for women for whom this
is — the whole process is a painful procedure, they use
ICSI to increase the likelihood that you will actually get
some embryos from the procedure for the women.
So we are saying that the industry is being irresponsible
by using ICSI when they don't need it, but the matter of fact
is that you don't know for those who are the 5 percent who
they are, and therefore, many clinics in order to make certain
that there are some embryos that are developed, do ICSI when
it may not be needed.
But, you see, that doesn't come through in the text that
is stated here. So I think that we should be a little bit
more — either indicate that there is this 5 percent where
it would be unsuccessful, or maybe modify the text here not
to be quite so critical as we are of this procedure.
CHAIRMAN KASS: If there is an implied criticism,
the implication will be removed, and the request is simply
for the reporting of the data and the indications, and if
there are additional indications, then of course we should
note that. That is a good point, and we will fix that.
Look, I am mindful of the clock, and let me do something
slightly out of order. I suspect that we need more time to
discuss Section 3 than Section 2, Section 2 being recommendations
to the professional societies and practitioners.
And let me simply go out of order and do Section 2 last
to make sure that we don't wind up at 5 minutes to 12:00 with
only 20 minutes or so to do Section 3. So, we will do Section
Let's turn to the targeted legislative measures, pages 13
through to the end. I repeat that these have been pruned,
and things that were contested last time have been removed,
and certain sorts of other difficulties ironed out.
And maybe we should keep our attention to the specific proposals
first, and worry about the fine tuning of the rationale, and
the discussion later. Page 16, the transfer, proscribe the
transfer for — by the way, let me say just — and in this
document I apologize, but it doesn't have this point that
was made the last time in it.
And these suggested targeted legislative measures were meant
to be temporary. It is indicated in passing that that is
the case, but we don't say that there should be a fixed time
on it, and that is for review, and that was one of those suggestions
made in the Council meeting last time and that will be added
to the final version. So these we are targeted legislative
measures of a temporary sort, at least until additional discussion
Then to page 16, proscribe the transfer for any purpose
of any human embryo into the body of any member of a non-
human species, and to prohibit the production of a hybrid
human- animal embryo by fertilization of human egg or animal
sperm, or an animal egg by human sperm.
These are the two things that survived. There were more
things in the previous version. Dissents, objections, comments?
The Dean from Dartmouth.
DR. GAZZANIGA: Oh, geez. It is cold up there.
CHAIRMAN KASS: It is very cold.
DR. GAZZANIGA: You know, it is all sort of — you
know, this flows from the dignity of human procreation and
all of that, and I keep thinking of G.K. Chesterton's remark
to his son as he went off to college.
He said that with respect to sex, son, it is a ridiculous
posture, and I always get confused about where we launch from
here. So if you look at — I mean, what everybody wants
is a child out of any deal, right? A beautiful child.
And that normally occurs in 98 percent of the time through
mechanisms that we all know about, and love and respect.
But frequently it occurs through going to a lawyer's office,
and figuring out how to pay money to go adopt a child.
And I don't know. Maybe biomedicine is going to come up
with a mechanism where a husband and a wife can fertilize
an egg, and the woman can't have it implanted because of certain
medical problems, and you can think of a cow as a big tissue
culture to allow the baby to grow.
And what happens is that when the baby is ready for birth
the family seizes on the baby with all the love of any parent
and life goes on. So, you know, we take — a lot of these
things that have been put in there have been set up with this
crazy humanzee notion and that sort of thing.
And really I think, if we start fiddling around with this
language, that we may be stumbling upon possible future biomedical
advances don't seem very normal after a while.
So I am concerned with when we start introducing language
like the first item there.
CHAIRMAN KASS: Comments? Rebecca.
PROF. DRESSER: I like the way this is set up
because it is a temporary moratorium and it just shifts the
burden. In a sense, it says all right, if you come up with
something that seems to be covered by this within the time
frame of the operation, then you have to make your case and
explain why — you know, certainly it is safe, and needed,
and other alternatives don't sufficiently meet the need, and
that certainly that practice would be something that ought
to be publicly discussed before it went forward.
So I do think that the posture of this, that it sets up,
the procedural posture, leaves room for situations where a
new technique might develop that does seem to fall under this,
and might have a reasonable rationale, and there is still
the opportunity to present the case, and certainly the research
on that sort of a procedure would probably last longer than
these provisions, in terms of effect.
You know, they would go out of operation and then there
would be a new discussion about whether a more specific prohibition
or provision were needed. So I think the way that it is constructed,
it is sufficient to handle innovations like that, or other
CHAIRMAN KASS: Are there comments on this one? Janet.
DR. ROWLEY: Yeah. I assume in the staff's discussion
with representatives of the organizations that have a direct
interest in this, and that these were items that did pass
their scrutiny and have been retained.
In my discussions with other individuals, they are concerned
that it appears to paint the ART community in a less than
ethical light by implying that these things are something
that the scientists in the ART community are preparing to
do, and so we have heard certain discussions about some things
that have been done in other countries, but at least as far
as those practitioners in the States, they have real concerns
about even including these things because in their view this
is not something that they are planning to do.
DR. KRAUTHAMMER: We could take are of that by adding
the phrase, "without prejudice" and "without
implication," and that would take care of that, I think.
DR. ROWLEY: But if that is the case, then why do
it at all?
DR. KRAUTHAMMER: Because — not because some people
are doing it today, but because it is something that we believe
is abhorrent and ought to be at least not permitted until
people make the case otherwise. It seems rather simple.
CHAIRMAN KASS: In fact, the argument that we — I am not sure, Janet, that it would be fair to say that everything
that survives here has passed the scrutiny and claimed the
approval of the people with whom we have consulted, that is
not our task.
And our task is to learn from them, where we have done things
that we ourselves would recognize as unreasonable, or be educated
by them about things that would place undue burdens on their
I don't think that there is any implication here that the members
of this profession are unethical or unscrupulous. It is an expression
of the community's support at the moment to try to set certain boundaries,
and one of the ways in which the professionals could in fact show
that they are not under suspicion is to endorse these provisions.
I mean, these are exactly the sorts of things that the responsible
practitioners ought to be able to say and be offered — this
was a suggestion that we made in conversation with representatives
from ASRM. We have a stake, we would suggest, in making sure
that everybody understands that the profession has the highest
ethical standards, and doesn't mean to ride roughshod over
the boundaries that the community has established.
So we are trying to do those sorts of things for which they
might worry about Congress doing anything because they don't
like that. But we have tried to devise those kinds of very
modest things that ought to appeal to just about everybody,
other than those people who don't give a damn.
So there is no imputation that there is anything irresponsible
about practitioners or their society here. Paul McHugh.
DR. MCHUGH: Well, I may be saying something at once
obvious, but in relationship to this first thing, I have two
reasons for wanting to have it included. One of them is
simply the "ugh" factor.
I don't think that I can speak to the ordinary person in
America and say that we think that babies should come from
cows very simply, and so therefore the burden would be for
the scientists to say that this might be okay.
But I have a more practical concern and reason for wanting
to see this. I believe that it is not outside of anyone's
imagination that the process of putting an embryo into an
animal to let it proceed for a while would soon become a process
searching not for a live baby for these folk looking for a
baby, but for ultimately the harvesting of those embryos for
their bodily parts; their kidneys, their hearts, and the like.
And I find that repugnant, too.
CHAIRMAN KASS: Frank, and then Dan.
PROF. FUKUYAMA: Well, this just follows on the
last couple of comments, and this is actually, Mike, more
of a response to your written comments than to what you just
said, but I don't think that what you are defending is necessarily
the dignity of — you made the comment that human reproduction
is not all that different from the mammalian reproduction
But I think what is being — you know, you can at least
say that each species has its own reproductive rules, and
evolution has designed them to be an integrated whole. So
that a baboon presumably will not do very well if implanted,
or as a baboon won't do well if put in a human uterus.
And I would think that there are huge medical risks if you
create an embryo that has got, for example, animal — you
know, mitochondrial DNA, and if you — and I am sure that
there are all sorts of things in the developmental process
that go on within a uterus that are specific to a human uterus.
And so again this just reinforces the point that there is
a huge burden of proof that needs to be met before you start
violating what evolution seems to have designed as this fairly
integrated reproductive processes.
CHAIRMAN KASS: Dan Foster.
DR. FOSTER: I just want to make a small point in
response to Janet's. I don't know who you have been talking
to, but I am not very sympathetic to the view that this might
be in some sense a judgment on the ethical procedures. Let
me just turn to the scientific community already, and the
protection of human resources.
The scientific community found it extraordinarily abhorrent
that some of our greatest universities, and some of our very
best genetic people about deaths that have occurred doing
things that nobody thought should have been done.
I am not very moved by somebody who is in the ART saying,
well, you are impugning our integrity when already we know
that in the greatest of our universities, and in the whole
scientific community — well, I can't say whole, I don't
But I can tell you that universally condemned — and I
not going to mention the names — the things that were done
here. So I don't think we ought to be too worried about somebody's
concern about moral things when we know that the very best
scientists that we thought — well, I don't want to get started
on this, but we need to assume that because we can do certain
things that they are going to be done, and not just in rogue
private laboratories. But in the university laboratories
of the highest things.
So I am very much in favor of saying let's don't do crazy
things. I mean, I don't know what cow uteruses do, but I
know that some people think that prion disease, for example,
may in some sense be contagious. We know that cattle carry
E. coli, 25% of which are type O157 H7 that may be fatal from
HUS ( hemolytic uremic syndrome) from eating insufficiently
cooked hamburger. So it is a modest thing to say ' lets don't
do crazy things that we can do when we don't need to do them'
and I feel pretty strongly about that.
And as I said, I don't want to just hear somebody say, well,
we are impugning somebody. We have to be very careful about
what we do.
CHAIRMAN KASS: Anything further on these? Do you
want to move on? Let me make a procedural observation, because
Mike — and I don't know that you would regard all of these
answers as a satisfactory response to you, and I don't want
to put you on the spot.
But I am interested in going through all of the comments,
and if there remain — our aspiration was to produce something
that we could all agree to, but if it turns out that that
can't be done, then we will be left afterwards with trying
to sort this out.
And we will figure out a way to handle this either by removal
or perhaps by allowing the expression of individual dissent
in a very strong way on whatever it is.
This is to take the burden off of Mike from saying here
and now, okay, you guys have persuaded me. I doubt that is
the case, and I would like to at least see where we are on
some of the rest. Is that okay, Mike?
DR. GAZZANIGA: That is very kind of you, Leon, and
you are exactly right.
CHAIRMAN KASS: Okay. Let's move to the second.
This language has been changed to make it unambiguous; to
prohibit the transfer of a human embryo produced ex vivo to
a woman's uterus for any purpose other than to attempt to
produce a live- born child.
And the grounds of this have been laid out in the paragraph
before, but what we are concerned about is the correlate to
the previous one. If human embryos go anywhere, they go into
human uteruses, and if they go into uteruses, they go into
human uteruses, and what goes into a human uterus goes only
for the purpose of producing or trying to produce a child.
This I think the last time around had not even a whimper
of dissent. Are we all right?
DR. ROWLEY: Just as a point of clarification, I
assume that this language doesn't really prohibit the use
of PGD to select for an embryo that might be appropriate for
some other purpose, because that embryo is selected in general
to go to full- term. So that is not covered in this.
CHAIRMAN KASS: This solely has to do with for what
purpose may you — the previous language was to initiate
a pregnancy, and that was found to be — it was obscure and
it raised all kinds of worries that were unnecessary, and
so this is in effect to start a pregnancy by the transfer
of a human embryo conceived or produced ex vivo for any purpose
other than to yield a child.
It says nothing about what is done with embryos outside
that don't get transferred.
DR. ROWLEY: Or before the selection of the embryo
CHAIRMAN KASS: It says nothing about that at all.
This next provision was one that caused a lot of trouble,
but I think we have found with one exception, and I can call
attention to the problem in the language now, but the one
I think we have found a way to express this that was satisfactory
to the vocal disputants of the last occasion, with the important
exception that the presence of the word "and" on
the top of page 18 seems to imply that in order for something
to be ruled out it has to be guilty of all of those three
things. That doesn't really make sense. I think the language
should be "or" and the reason that we have listed
it this way is so that the footnote could operationally define
in one footnote exactly what it is that is meant.
Prohibitive attempts to conceive a child, footnote, and
by definition that means to create ex vivo an embryo of this
sort with the intent to transfer to a woman's body to initiate
a pregnancy. Prohibit attempts to conceive a child by any
means other than the union of egg and sperm by using gametes
obtained from a human fetus, or derived from human embryonic
stem cells, or by fusing blastomers from two or more embryos.
These were under discussion the last time. Michael.
PROF. SANDEL: Well, I think removing the "and"
so that it is clear that we are not asking Congress to prohibit
some bizarre compound activity that would never arise is a
But I am not sure that "or" removes the ambiguity
altogether, because it could be read as proposing that Congress
prohibit one or another of these three things.
So what I would urge is that we remove the ambiguity by
simply adopting and by repeating the verb clause for each
of the three bullet points as we have done with all of the
others, this may seem like a semantic distinction, but I think
that it is important for reasons that we could pursue, and
that came up last time, but simply say prohibit attempts to
conceive a child by any means other than the union of egg
and sperm, with the asterisk and the footnote.
And then repeat that phrase in each of the two other proposed
prohibited activities with the same asterisk and with the
CHAIRMAN KASS: I don't see any problem with doing
that. We were — quite frankly, this was one of these places
where footnoting and simply the questions of the mechanics
of getting footnotes on the page, and repeating footnotes,
suddenly produced a way that you could probably do this with
one footnote, and the thing was restructured.
But we are perfectly happy to restore the less ambiguous
way and have the same footnote referred to three times or
have it three separate times. It is not a problem. Are we
okay on this? Difficulties?
CHAIRMAN KASS: We come to the fourth set of recommendations,
pages 18 and 19, and here once again this may be contested.
This recommendation, these recommendations, do not say anything
about the licitness or illicitness of embryo research as such.
But even the people who would be or who would prefer that
there be no embryo experimentation, but recognizing that it
goes on, are willing to join with others.
In fact, the minority position in the cloning report did
call for regulation of this, and setting an upper boundary,
that there should be some kind of upper limit on the age of
embryos available for research, at least at the present time.
And that this is an attempt to suggest the prohibition of
the use or preservation of those embryos that are already
being used solely for the purposes of research beyond a designated
stage of embryonic development, and we left it to the Congress
to find its date.
We suggested the range, and then as a result of a long discussion
the last time, and what was left of the commercial matter
was to prohibit the buying and selling of human embryos.
The gametes part of that as you will recall was in there last
time and is not at the present time.
DR. KRAUTHAMMER: Leon, I think that I might want
to include the range that we have considered, the 10 to 14
days, in the body of it.
CHAIRMAN KASS: In the body of the recommendation?
DR. KRAUTHAMMER: Yes. I am a little wary about
leaving it entirely up on the air, because it would allow — I mean, if we are assuming that this will go to Congress,
and there might be pressure to allow higher upper limits,
and I think most of us, or I think all of us would agree that
the upper limit ought to be within this range.
And I think it would be helpful to Congress to have that
as a guideline.
CHAIRMAN KASS: As a guide posture, yes. Any objections
if we put that into the text? I mean, they are obviously
free to ignore all of this, or free to ignore that, and once
again this is for the time being recommendation, and even
our representatives from BIO said that they would for the
time being favor such an upper limit if I am not mis- remembering
We might even have a fair amount of public support on this
as well. Are there any objections on any of this?
CHAIRMAN KASS: We are left with the patenting matter,
and I think that people probably know that — if I can get
my cheat sheet here, that the House — that this recommendation
might be rendered moot by developments in the current session
of Congress. The House of Representatives has included an
amendment to the Commerce, Justice, State Appropriations Bill
for Fiscal Year 2004 that would preclude the Patent Office
from issuing a patent, "On claims directed to or encompassing
a human organism."
And the Patent Office has supported this amendment, and
the House — the Senate and House conferees have agreed to
include this amendment with some explanatory language in the
final version of the bill, but the Senate has yet to vote
on the bill, but may do so as early as next week.
If that in fact happens, we can simply delete this provision
as being rendered moot. Michael.
PROF. SANDEL: Is there any good reason that
we have for using the word, the phrase, human embryos or fetuses,
instead of the word that is in the legislation that you just
read, human organism?
CHAIRMAN KASS: I see no reason not to even prefer
it; to encompassing human organisms at any stage of development
I think would be —
PROF. MEILAENDER: I don't see any reason not
to prefer it. I think the reason that it is here is that
it came immediately under the section on respect for early
stages of human life.
And that is probably the reason, and it would need to be
clear that it was not a part of that section if the language
DR. KRAUTHAMMER: What does organism add that embryo
or fetus would not? I mean, what are we losing by using embryo
PROF. SANDEL: I don't know the legislative history
that led them to adopt organism. I would be interested to
know and to consider that before we decide what language makes
the most sense to us.
CHAIRMAN KASS: Charles.
DR. KRAUTHAMMER: If it is a question of just matching
the language, then I have no objection. I was just wondering
whether there is a substantive difference. I don't really
see any other than organism might mean a full human, which
would be an anti- slavery provision, which would be nice,
but it is 160 years a little bit late.
So I had no objection if it is just a matter of procedure,
but I would be interested if there is an actual difference
CHAIRMAN KASS: Carter, please.
MR. SNEAD: I was just going to add a point of information
on the legislative history to speak to the evolution of the
language in that particular provision.
In the version that has been tentatively approved by the
conferees, they have included in the language now — they
have agreed in principle to include language, a colloquy between
two members of the House of Representatives to clarify, because
there was some question about what the word organism referred
to, they have now included a colloquy and some explanatory
language from the manager's statement that clarifies that
they are referring to embryos, fetuses, and so on, and so
So this, just by way of explaining or responding to your
curiosity about the legislative history.
DR. FOSTER: My question is —
CHAIRMAN KASS: Carter go ahead.
DR. FOSTER: Well, I have not heard about this, but
does this imply — does this affect things like genes from
humans and so forth and have they been patented?
MR. SNEAD: No. The explanatory language in the amendment
is very similar to the explanatory language in our statement
here, wherein we say that the language of any such statute
would need to take some care not to exclude from patentability
certain things, the likes of which you have described.
And the explanatory language in the manager's statement
does precisely the same thing. It says this is not meant
to exclude patents on even stem cell lines and gene sequences,
and so forth.
PROF. SANDEL: Do we know why they changed it,
the language in the law, from embryos to organisms?
MR. SNEAD: My understanding of the evolution of
the current language is that Representative Weldon from Florida
included this language that was quoted by Leon.
When it got to the conference there was some negotiation
of some possible addenda to further explain what the language
means, and the result, which has not been agreed to formally,
but has been agreed to in principle, is to include explanatory
language. So they began with organism, and now they have
added this explanatory language, and there was some negotiation
about what that language meant.
PROF. SANDEL: Would it be possible for us to
get copies of that legislative record that we could — in
case there are reasons that have not occurred to us about
the significance of the choice of the term organism?
CHAIRMAN KASS: We will be glad to do that, and in
fact I was going to recommend that we do that and study this
matter before agreeing to the final language, if indeed if
has not been rendered moot as a result.
MR. SNEAD: Just a last — I'm sorry to keep interrupting,
but the last point of clarification is that this is in the
context of an appropriations bill also, and the precise language
speaks to allocation of funds for the issuance of patents
on certain things.
CHAIRMAN KASS: I see.
MR. SNEAD: It is not merely a statute that proclaims
CHAIRMAN KASS: So this is a rider on an appropriations
bill and lasts just as long as that bill?
MR. SNEAD: That's exactly right, and in that way
it is similar to the Dickey Amendment.
CHAIRMAN KASS: Then we are it seems to me still
in business here on this, regardless. Was there someone with
a hand that I failed to recognize here? We will get this
information and study the matter, and we will advise you as
to what we have learned, and then reformulate exactly.
Am I right in saying that with the exception of Mike and
his concerns which may extend not only to the comment that
he made, that the rest of us are all right with the formulations
that are here, and that there is certain language to be cleaned
We want your line edits on the rationale and justification.
We will take the changes in the third point as Michael suggested,
and we will do what we need to do to clarify this last point
on the patent thing.
Let's go back and look at the recommendations addressed
to the professional societies, and practitioners. Suggestions
to improve informed decision making, and encouragement to
treat the children who are the products of ART as relevant
Some encouragement to improve the enforcement of their own
existing guidelines, and improve procedures for the movement
of experimental procedures into the clinical practice, and
to create and enforce minimum uniform standards for the protection
of human subjects and the invitation that they join the kind
of activity we are engaged in here as setting thereforth their
own self- imposed ethical boundaries in the name of their
These are the things that we think all people who are members
of our society shouldn't mind, though. Obviously, we have
discussed these things, and I think that some of these things
will probably simply be welcome.
They are mostly hortatory, and we would like to think that
they would receive serious consideration. We have every reason
to think that they would be considered seriously even if there
And I myself don't see any reason why we shouldn't at least
suggest these things for their consideration. But I think
that this was the sense of the group the last time. Some
of these items may strike you as not warranting inclusion,
which is why we brought them before you again.
Comments or questions on any of these items? Janet.
DR. ROWLEY: Well, in line with my earlier comments,
and so I recognize what Dan is saying, I think that we should
be more cognizant of the fact that most of the physicians
and scientists working in ART are in fact committed to ethical
practices, and are responsible individuals.
And so I would like to see the preamble to this section
at least include a sentence that we recognize that they are
individuals who have the health and well- being of the woman,
as well as the child, as a high concern, and I think that
that should be stated.
It has been suggested to me that under Item A, improved
informed decision making, that in fact the standardized forms
for consent, et cetera, may be difficult to develop because
there are certain State laws that are different amongst the
States, and therefore trying to resolve the differences might
And Rebecca or somebody would know better than I whether
there are really such State laws that might make a uniform
consent form impractical.
CHAIRMAN KASS: Rebecca, please.
PROF. DRESSER: One thing to do would be to — I think at one point it said model. Basically, I think
the idea here is that there should be a basic set of substantive
information that is provided to all prospective patients,
and then clinics — there will be information that should
vary from setting to setting, just because of various features
of the clinic, and so forth.
So I don't think this is saying that there is one form for
everyone, but that the basics would be there, and then it
could be tailored to the specific setting.
And I am not aware of any — I mean, there may be some
laws setting forth something like, well, perspective patients
should be told the success rates, or something like that.
But I don't think that there are any laws that would conflict
with laws in other States. So I don't think it is a serious
CHAIRMAN KASS: Also, I think one could say that
at least one of the patient groups that we have spoken to
is quite interested in this thing. I think more could be
done here to get this information out.
So it is not just giving consent, but it really is to make
the decision making more informed, and we have been guided
in part by Rebecca, and in part by requests from some of the
patient groups that we have spoken with on this point. Mike,
DR. GAZZANIGA: Paul, help me with this. Let's
say on page 11 that we were going after psychiatry, and the
first sentence would read, "The psychiatrist should take
measures to ensure the health and safety of all participants
after they leave the psychiatrist's care and his building."
I mean, isn't this sort of a harsh way to introduce the
notion that maybe the ART physician is raising somewhere?
All you are pushing here for is that we would like some epidemiology
to make sure that — well, I don't get the harshness of this
paragraph, and I would just think that — and I am trying
to imagine a physician being told, lectured to, about how
they might not be caring correctly for the medical procedures
that they administer.
DR. MCHUGH: Well, it is interesting that you mention
psychiatry, and the long term effects, and effects of other
people that are involved in the enterprise, because there
are laws as you know in the State that — in all the States
now, that if a psychiatrist in caring for one patient discovers
that that patient might be a danger, or a serious danger to
some other patient, or some other person, that it is intended
upon that to break the confidence of this procedure, and they
are told in no uncertain terms in the courts that they will
be held responsible for any damage that could be done to that
So to some extent, Mike, that kind of harsh language for
psychiatrists in particular is already on the books.
CHAIRMAN KASS: Let me also — sorry. Let me respond
to the specific content here, and if the language seems accusatory,
we will change it. What is behind this is this.
And this came out in the conversation with Sandy Carson
and Sean Tipton, that for the most part the people who practice
ART, the clinicians, regard their patients as the infertile
individuals as patients.
But what is recognized clearly is that — and in fact that
is one of the concerns that animates this entire report, an
interest in the children who are produced, and who are not
And yet those children are affected by the things co- incident
with their conception. And the question is whose responsibility
is it to start to pay attention to those things.
Very interestingly, after Sandy Carson made her own presentation
here, she reported that the society was beginning to produce
new collaborations with the Association of Pediatricians,
and that the concern for the children produced by these procedures
was now increasingly part of their own concern.
Up until this point, they have said quite frankly that our
clients are the infertile couple, and somebody else looks
after the children. But this is one of those areas in medicine
where in fact the treatment of these individuals means the
production of another individual who is joyously present,
but nevertheless somehow at risk, and one wants to somehow
address the concern for those participants who have so far
not been considered part of the domain of concern.
How to do this given that the reproductive endocrinologists
are not going to care for the woman through her pregnancy,
and are certainly not going to look after the child is a difficult
matter, but we have at least encouraged the society to think
about that individual who is in fact one of the participants,
though he or she is not yet spoken up. Bill May.
DR. MAY: It seems to me that there have been two
points made. One is the question of whether if you offer
comments by way of encouragements to professional society,
you are tainting and offering accusatory judgment against
them, and it seems to me that Charles' point that in fact
your concern was protecting that community, and not simply
tainting them by the development of advisory here.
But, second, there is an additional problem of disaggregation
of services in health care. So it is not simply a question
of use- abuse, and to worry about abuses.
The problem with the disaggregation of health services is
a general problem, which is more acute here, because you have
got the services of somebody assisting in reproduction, and
then you punt on to somebody else.
And it is compensating for this general problem in our health
care system by suggesting that those who offer one service
ought to have sympathy to the problem of continuity in health
care, which in this case includes a new human being.
And so it is not simply charging against abuse, but enlarging
the sense of responsibility as it bears on a general problem,
which our health care system faces in the balkanization of
CHAIRMAN KASS: That is a very nice point, Bill,
and I think the rationale for discussing this could certainly
include those points. Dan.
DR. FOSTER: In the first place, I want to agree
that we ought to get the harsh things out, and I certainly — and maybe in your sentence we ought to say that we know
that the vast majority of all physicians in ART are highly
ethical and so forth, and I think we ought to use vast, and
this is not an attack on anybody.
But here — well, I am puzzled, along with Bill May. I
mean, medicine is a continuity, and we do pass on. I mean,
when you have your coronary bypass surgery, then it goes on
to the cardiologist. And the bypass surgeon is not — I
mean, he cares about the patient, and wants to be informed
about the patient, but I really don't see what the person,
the physician who is inducing the pregnancy, what that person
can do once the pregnancy has started, or if the child becomes
born, and the pediatricians, and then the obstetrician passes
And then when you are 16 or 17 years old, then the pediatrician
passes the patient to the internist, or whatever. I mean,
I really don't — I have been troubled about what we are
trying to accomplish here. I mean, in there, and I think
it would — I guess you could say that you can improve communication
and let the obstetrician know if there are complications leading
to abortion and so forth, so that there is new information.
But I don't see — and then you could say that the internist
passes it on to the geriatrician when somebody gets to be
65 or something. I mean, medicine is a continuity, but it
is also in practice a discontinuity, and I don't see how what
we are saying to the ART people that they have a responsibility
once they have done their duty and done their work.
I mean, I think this is — and it may be a little bit superfluous
to it, but —
CHAIRMAN KASS: Let me try, Dan, if I might. I mean,
I take your point. I think that the reason that this comes
up at all is to repeat this is a peculiar branch of medicine
because the treatment involves the creation of a new individual.
When we get passed from our cardiologist to our urologist,
to our internists, it is the same person who goes along.
Here what is being passed on, though invisible, is a being
who is both the product, but also the patient, of this procedure,
and we don't want to somehow say, or at least at the moment
no one is going to say that when you ask, well, the ethics
of experimentation, or the ethics of practice in the ART clinic
somehow has to take into account the rights of the embryos
that are created. That is not going to pass.
But it is sort of odd to say, to hear people say, that all
of the participants in ART are the doctor, the man, the sperm
donor, the egg donor, and the woman who carries the child.
There is another being that is being produced here, and
becomes eventually a being, or whatever it is. And to begin
to think about one's activity, mindful of the presence of
that eventually to be produced being I think affects also
how you practice. It means that you begin to cooperate in
the longitudinal studies on the well being of those children,
and it means that you think about, for example, the effect
of multiple embryo transfers.
And you think not just about increasing the chances that
your clients are going to have a baby, but you think also
about the effects on the children who are going to be born
from being one of a number of multitudes once one knows that
there are huge health risks associated with multiples.
And we are not telling anybody what to do exactly, but to
say enlarge the purview of who you think your patients are
when you think about what standard ordinary practice is in
And I think that there is some indication that — and maybe
one should say this — that the society by itself increasingly
recognizes this, especially if we take what looks like accusatory
language out that they would find anything to dissent from
here, though that they might be willing indeed to enter more
closely into follow- up studies with the pediatricians, because
they have an interest in what the effects are of the procedures
that they are using on the children who come to be born.
That, I think, would be the justification for singling this
out for special attention.
DR. FOSTER: Well, okay. I mean, I understand what
you are saying, and you are saying that the primary emphasis
of the discipline is to get a baby, and what you want to say
is that it is not only to improve the parent's hope of getting
a baby, but that what is being produced ought to be done in
the safest way, and that is why we are going to try to get
And let's say if you try to take a cell out of a blastocyst,
you know, does that mess up something in the future, and that
is information that would be there.
But when you read this, it sort of is like saying to participate
with the pediatricians and so forth, and it sort of moves
beyond into this discontinuity, and that is what is bothering
It seems to me that the emphasis of saying that we need
to pay special care to improve our concern for the product
of this is really part of what they do, and is implicit in
what they do, that we have to try to get that information.
But I don't see how — the only thing that I don't see,
it does kind of — you know, when you say should collaborate
with pediatricians in making decisions, or obstetricians for
that matter that might affect the health and safety of these
Well, once the conception is there, then that becomes the
business of the obstetrician, and then subsequently — and
what I am concerned about is that it looks like their assignment
is to act clinically when it is beyond the realm of what they
CHAIRMAN KASS: That is a point well taken. Absolutely
well taken, and we will fix that. We will try to make this
say what we intend and no more, and not to proscribe. Mike,
DR. GAZZANIGA: Just a sentence on E that I will
just mention, and we can sort it out later. The sentence,
"This problem is compounded by the fact that there is
not a clear distinction between research and innovative clinical
practice in the context of ART."
You can say that in the context of all medicine. There
is always little diddling at the edges and clinicians change
the application of the medication, or surgery, and then it
becomes a hypothesis, and then it becomes a clinical trial.
And that just goes on, whether you like it or not, and I
just think that to — I mean, you may be of the opinion that
shouldn't go on in ART, but that is kind of how medicine works,
and I just think it sticks out as kind of naive.
CHAIRMAN KASS: Mary Ann.
PROF. GLENDON: I share the concern about accusatory
language, but I hope that that concern isn't going to be translated
into playing down the fact that after hearing many people
on this issue that we have uncovered serious concerns about
informed decision making, and about protection of women and
children. And I hope, too, that in this report concentrating
on self- regulation by the profession on the one hand, and
legislative regulation potentially on the other hand, or legislative
measures I should say on the other hand, that we do not overlook
the most important stakeholder if you want to use that word,
which is the public.
One of the things that we have learned is that the public,
like ourselves before we got educated on this, is lacking
essential information about these procedures.
And one of our charges as a bioethics Council is to raise
the level of the public discussion to ensure full public deliberation
of these issues, and the public cannot deliberate without
So there is yet another stakeholder and another reason for
having the best possible information about these procedures.
CHAIRMAN KASS: Frank.
PROF. FUKUYAMA: Is it okay to make a general
comment and not on —
CHAIRMAN KASS: Please.
PROF. FUKUYAMA: I think the public as a stakeholder
is right, but I again think that the industry itself has really
got to think carefully about its own self- interests in this
There is this cautionary tale unfolding in another area,
which is Mad Cow Disease. If you look back at the entire
European opposition to genetically modified foods, a lot of
Americans tend to think that this is all completely irrational,
and it has to do with the European protectionism and love
of regulation, and so on and so forth.
I think that if you look at historically how this came about,
it was as the result of a regulatory failure. That is to
say, that Europeans didn't actually regulate for environmental
purposes more heavily than the United States in the 1970s,
and they actually regulated more lightly.
There are irrational aspects to the European opposition
to biotechnology, but the single thing that drove this entire
catastrophe for the agricultural biotech industry there was
the regulatory failure, and how the British food safety regulators
responded to the initial outbreak of BSE.
They reassured everybody that it was safe, and the result
was that they were proven wrong, and people reacted perfectly
rationally to this information about their own regulators.
And that they had either been captured by the industry,
or that they weren't competent to do their job and so forth.
So now you have a lot of consequences, not just heavier regulation
of beef throughout Europe, but it has had these spill- over
effects to the opposition to genetically modified foods across
And, you know, I have this sinking feeling when you watch
the American beef industry respond to the current Mad Cow
problem that the beef industry did, and they say, well, we
are regulating ourselves, and it should be sufficient, and
they are just setting themselves up, and I have no idea how
many cases of mad cow disease there are out there right now.
But there is a really big danger that industry, in taking
this very light regulatory approach, and so I would think
that the big stakeholders, the industry itself, has got to
think really carefully about those precedents and its own
You don't want to set up a case where a rogue practitioner
does something that produces a very disproportionate political
backlash. And all of the big failures in the last few decades
have been from industries that were too lightly regulated.
You know, accounting, energy transmission. I mean, we have
seen a lot of cases of this where the industry participants
said look, we're taking care of it, and we have our own best
interests at heart, and so on and so forth. And it proved
not to be the case.
CHAIRMAN KASS: Any final comments? Well, I think
we have done very well. I think we are fairly close. We
see places where the text has to be fixed, and there are some
points still in contention about the restoration of a missing
paragraph on keeping track of the counts of embryos.
We have conversations to have with at least one of our members,
and line editing suggestions can come in when the new document
as a whole comes to you, which we hope will be within the
next week or two.
And there will be plenty of time for a thorough review.
We will review as we did with the stem cell 3 weeks for review,
and we will receive the comments, and you will get the responses
to all of your comments, and if all goes well, the target
date for this would be the April meeting to be released.
And I don't see any reason given what I have seen why we
can't make that deadline. We are right on time. At two o'clock
this afternoon, we have two invited guests to introduce us
to the wonderful field of neuroscience and neuropsychiatry,
Robert Michels, and Jonathan Cohen.
I think they will probably both be here in time for the
first session, but let's be sure that all of you are. Two
o'clock in this room, and the meeting is adjourned for lunch.
(Whereupon, at 12:15 p.m., a luncheon recess