THURSDAY, April 1, 2004
Session 1: Biotechnology and Public Policy: Council’s
Report to the President
of Reproduction & Responsibility: The Regulation
of New Biotechnologies
CHAIRMAN KASS: The main purpose of this
first session on biotechnology and public policy is the release
of the Council's report to the President, "Reproduction
and Responsibility: The Regulation of New Biotechnologies,"
copies of which members should have at their places.
The procedure for this session is as follows. I will make
some relatively lengthy remarks introducing the report and
trying to summarize its contents and conclude with some statements
of what I regard to be the report's major achievements
Individual members who have expressed the wish to comment
will then do so. I think by my list we have either eight—we have either nine or 10 such people who want to say something
briefly, two to three minutes.
There are, I believe, some members of the public with whom
we have consulted over the course of writing this report who
have submitted personal statements, and some of them I think
would like to read them, and then the floor will be open for
comments and questions from the media.
Let me begin. The report that we release today, "Reproduction
and Responsibility: The Regulation of New Biotechnologies,"
examines policy and regulatory issues that arise at the intersection
of assisted reproductive technologies and genomic knowledge—an increasingly busy intersection and one that raises a
daunting array of opportunities and dilemmas for patients
suffering with infertility and for doctors and researchers.
It raises the prospect, but also certain kinds of risks,
of new life for children born with these procedures. And
it has certain social implications important for regulators
and policymakers and, indeed, for the American public as a
The report is the product of a two-year process for us,
which really began at the very first meeting of this Council
in January 2002 when, you will recall, Frank Fukuyama expressed
the hope that as one of its projects this Council might explore
how new biotechnologies are regulated in the United States
and perhaps recommend some ways that regulatory practices
could be improved, given new technologies and the new sorts
of challenges that they represent.
With time, and given the other projects in the last term
of the Council, the term of which this report is, in fact,
the final product, we put that focus of regulation on the
more particular domain of assisted—of the issues that arise
at the confluence of assisted reproductive technologies, genetic
testing and selection, sex selection, and embryo research.
In the cloning report published in July of 2002, the Council
stated frankly that further inquiry into the current state
of regulation in this entire area was necessary. And since
that time we have, in fact, been taking this up.
We've devoted a very significant amount of our time
to this project. We've had 26 public sessions devoted
to it. We've had presentations from a great many experts
and stakeholders, including patient groups, professional societies,
government agencies, policy experts, and people who are involved
in the regulation of these areas in other countries.
We put out a call for public comment and received valuable
written comments from dozens of groups and individuals around
the country, and in the report we list and acknowledge the
help that we have received from all of these people, and we
are very grateful to those present and those not present for
The Council, with the help of the staff, produced this—took all of this in and produced the report that we have before
us. The bulk of this report is, in fact, a diagnostic document
laying out the present state of regulation of these fields
to the United States, public and private, governmental and
professional, federal and state. And it concludes with some
modest interim recommendations for how a few outstanding problems
might be dealt with in ways that we think should be agreeable
to just about everyone involved.
We have not at this time recommended major institutional
reform or major institutional innovations, because a great
deal of what we have found in our review of this field is
that much remains to be known. We need more basic data regarding
current practices and their impact to find out how big a problem
this really is.
We need to figure out the effectiveness of the rules and
regulations that now exist, both governmental and professional,
and we need to explore the costs—the benefits and the harms
of any kind of new innovations that anybody would like to
Before going on, I want to say—I want to say something
about the staff work that has gone into this. I mean, the
members have contributed enormously, reading many, many drafts.
But the real credit for this report belongs to the staff,
and especially to Carter Snead, our General Counsel, who has
taken the lead on this project.
And let me say that this staff has put out five volumes,
four reports and an anthology, in 26 months. They are extraordinarily
devoted to their work, top to bottom. The morale in the office
is extraordinarily high, because people like what they do.
They work well with one another. They believe in what we've
And I would like at this point simply to express my profound
gratitude on behalf of all the members to the entire staff,
top to bottom, for what you've done. So thank you very
Before I get to the actual content of the report, we should
point out that people who read the transcripts of our meetings
and the discussions that produced this report will give you
a sense of the fact that this Council has deep disagreements
And if you read the recommendations in this report, you
will discover that—which are made unanimously by this Council—you can see how people who nevertheless disagree profoundly
on some issues can nevertheless find some common ground.
And I think this—as I will say at the end, I think this
is really one of the great achievements of this report.
And I hope it offers an example to policymakers about the
way in which, notwithstanding our continuing disagreements
and arguments, we can find common ground and even seize it
as we continue to debate those other things that don't
lend themselves so easily.
I think most people are going to be interested, at least
on this occasion, in the recommendations. But before I get
to that, let me give you a kind of overview, a guided tour
to the whole document, so that you can have a sense of what's
in the report.
The report is in three parts. There's an introduction;
Part 1 is the diagnostic survey, which is the bulk of the
report; Part 2 explores policy options and concludes with
The brief introduction lays out just why the Council has
set out to explore this area and what we take to be some of
the most important concerns and values that should guide anybody
interested in exploring regulation—from the health and well-being
of infertility patients and their children, to the desire
to seek new therapies for the suffering and the sick, to the
responsibility to protect and respect human life, and to a
number of other critical issues of privacy, equity, freedom,
The report is guided and motivated by all of these, and
the introduction lays out these values at least in some beginning
The great bulk of the document, to repeat, is devoted to
a diagnosis of current regulatory practices in different areas
having to do with the intersection of assisted reproduction
and genetic knowledge. Assisted reproduction is not, as such,
our focus, though we have looked at how it is currently regulated
in the course of our diagnosis, because assisted reproduction
is, in practice, the necessary gateway to all of the newer
technologies present and projected that will affect human
Any oversight or regulation of the use of genetic technologies
in human reproduction will, therefore, necessarily depend
on the systems that oversee and regulate assisted reproduction
itself. Therefore, in Chapter 2, we begin by looking at the
state of the art in assisted reproduction, laying out in general
some relevant ethical issues that need to be addressed, and
then examining in great detail the variety of ways in which
the practice is regulated.
And by the way, "regulated" here is a very loosely
used term. I mean, it doesn't mean law and proscriptions.
It means anything that affects the practice by deliberate
design, professional guidelines, and norms primarily preeminent
This three-part approach—techniques and practices, some
ethical questions, and exploration of existing regulation—is the model for how we examine the rest of the techniques
that we take up in the diagnostic portion of the report.
In Chapter 3, Genetic Screening and Selection; in Chapter
4, Modification of Traits and Characteristics, where it's
important for me to point out that in this report, as the
Council has done before, we point out that significant genetic
modification of traits through genetic manipulation is simply
not in the offing in the foreseeable future.
In Chapter 5, research on in vitro embryos; in Chapter 6,
some issues of commerce that arise in the various fields and
that carry their own regulatory challenges; in Chapter 7,
we briefly conclude and summarize the diagnostic section.
All of this is brought together in the report's eighth
chapter, which offers in a succinct and organized form the
Council's findings in the light of the extensive diagnostic
survey. These findings you can find listed in the Executive
Summary, Roman Numeral pages 43 to 44.
And I won't read them all here, but one of the things
that we have discovered is that there really is a lack of
basic data on the effects of assisted reproduction and associated
technologies on the health and the well being of the women
and the children involved.
The findings show that right now, although there are various
kinds of regulatory practices in place, there is really no
uniform comprehensive or enforceable system of data collection,
monitoring, or oversight for the biotechnologies affecting
human reproduction, and that there is minimum government involvement
in the regulation of these technologies with the notable exception
of gene transfer technologies, where regulation is really
quite effective through the RAC and the NIH.
There is, however, fairly extensive professional self-regulation
of some of these practices, even if compliance is voluntary.
We find that there are no uniform rules regarding access to
assisted reproduction or insurance coverage, and with regard
to the new technologies we find that experimental technologies
that work move very quickly into general practice where their
use becomes widespread pretty rapidly, though not necessarily
with prospective studies to study their effects.
These are some of the findings that emerged from the Council's
review of the field, and it's important to understand
that none of them mean simply that some particular action
is called for. In some cases, what we have found is that
the field does not differ from how things are really done
in medicine in general, and in some cases we have not found
that the present situation really calls for change.
In short, this preliminary review and diagnosis has not
led the Council at this stage to make any sweeping suggestions
for institutional reform or institutional change. Nevertheless,
we thought to at least advance the discussion, in the ninth
chapter we set forth certain kinds of policy options that
might be available, just to show the range of the options
that exist, or that have been pursued elsewhere in the world
or in other fields.
We lay these out to offer a sense of the range of what might
be done rather than as examples of what we now think should
be done. And we make it quite clear that, given the preliminary
character of this report and the fact that our review of the
field has turned up a number of areas where crucial data are
still lacking, the Council is not prepared to recommend sweeping
institutional reform or innovation.
Instead, members have sought—in the interim while the
conversation and discussion proceeds—we have tried to see
whether we could agree on some modest measures to alleviate
some clear and significant present problems, including especially
the lack of information on certain key practices and their
And these measures are laid out in the chapter's tenth
and final chapter, the recommendations chapter. And in that
chapter we offer interim measures that we believe should be
adopted immediately, and these recommendations, I repeat,
have been offered by the Council unanimously.
The strategy here in the recommendations chapter was let
us set aside for the time being those things on which we disagree,
and let us see whether we can in the interim, as modest temporary
measures, make proposals that all of us could stand behind.
The recommendations fall into three categories, and for
those who would like to follow, you can find these recommendations
in the Executive Summary. The defense of them is in Chapter
10, but if you want to see them succinctly they appear in
Roman numerals 46 to 49 of the Executive Summary, in the front
matter of the book.
Three categories of recommendations—the first are federal
studies, data collection, reporting, and monitoring regarding
the uses and effects of these technologies. Here we are recommending
federally funded studies to examine the impact of various
assisted reproductive technologies on the health and development
of children born with their aid and on women who undergo treatment.
We also recommend a few discrete steps to strengthen and
augment the one existing piece of federal legislation—the
Fertility Clinic Success Rate and Certification Act—the
Act which provides information to people seeking fertility
These measures we recommend to help bring the law up to
speed with new technologies that have developed since the
law was enacted and to better protect consumers and patients.
They are very much in the spirit of the law that already exists
on this subject, and these recommendations have been drafted
with—in consultation with the professionals who work in
Let me emphasize one item here that I think is of special
interest. This Council has taken special note of the importance
of learning about the implications and effects of these technologies
on the children who are born with their aid.
There have been no longitudinal prospective studies of the
children born as a result of assisted—with the help of assisted
reproductive technologies—despite the fact that these practices
have been flourishing since 1978. There are lots of reasons
for this. We're not second-guessing the failure to do
so. There's questions of funding. There's questions
of privacy. There are all sorts of matters.
But one of the reasons I think that there hasn't been
this much attention is that the profession of—the reproductive
endocrinologists—have, for perfectly obvious reasons, regarded
the infertile couples and the adults as their primary patients.
When the pregnancy is achieved, the patients are turned over
to the obstetricians, and it is only late in the day that
the pediatricians get into the story.
One of the real important contributions, I think of this
report, is to shine the light on the importance of attending
to the children and learning much more about what this means
for them now and in the future.
The second set of recommendations are addressed to the professional
societies and the practitioners in the field of assisted reproduction.
There is a fair amount of regulation that is self-regulation
in this area, as there is in medicine in general, but we have
suggested a few ways in which that self-regulation might be
improved for the benefit of all involved.
These include a strengthening of informed patient decisionmaking,
improved enforcement of the societies' own existing guidelines,
and suggests to them development of additional standards for
human subject protection. And these you could find on page 47.
The third category of recommendations, the ones that are
likely to get the most public attention, consist of a few
targeted legislative measures. In the course of our review,
the Council has observed the fast-moving pace of research
and innovation in this field. We have noticed that there
are various kinds of values and goods connected with human
reproduction that we hold dear and that we would like at least
And since we do not know whether or when or even—whether
or when any kind of more formal regulatory or oversight mechanism
would be developed in the future, we thought that since we
are making this as an interim report we ought to think about
whether there are interim measures that we could suggest that
could at least set certain kinds of boundaries to protect
things that we hold dear while the public deliberation goes
And we have decided that there are certain areas that need
special attention, and we recommend in this report that Congress
should consider some special targeted legislative moratorium.
The report itself in Chapter 10 offers extensive discussion
of the reasons for these recommendations and gives the reasons
for—and it also discusses the aims that we think that these
targeted measures should serve. And these are found on pages
222 through 225, 227, of the report.
These recommendations are in order to help preserve a reasonable
boundary between the human and the non-human, or between the
human and the animal in human procreation, to preserve respect
for women and human pregnancy, preventing certain exploitive
and degrading practices, to show respect for children conceived
with the aid of assisted reproductive technologies, securing
for them the same rights and human attachments naturally available
to children conceived in vivo, and to set some agreed-upon
boundaries on how embryos may be used and treated notwithstanding
the fact that we have lots of disagreement in this Council
about the embryo question in its entirety.
Returning to the particulars, therefore, with respect to
the first point, the Council calls for the prohibition of
the transfer for any purpose of a human embryo to the body
of any member of a non-human species for purposes of research
to prohibit the formation of hybrid human-animal embryos by
fertilization of human egg and human sperm.
Under the second category, that there should not be pregnancies
initiated for any purpose other than to produce a live-born
child. That is to say, pregnancies are not for the purpose
of experimentation or for harvesting body parts.
With respect to the child, we call for a proscription on
conceiving a child by any means other than the union of egg
and sperm, where conceiving a child is carefully defined to
mean the creation of an embryo ex vivo with the intent of
transferring it to a woman's body to begin a pregnancy.
I'll say something more about this, but it has been
noted that one of the practices that this would include would
be, of course, the cloning of an embryo with the intent to
transfer it. And so with respect to cloning, this recommendation
is really a restatement in greater detail of an earlier Council
position unanimously opposed to cloning for producing children.
The differences, of course, on the cloning for research
remain, and I will allude to that further. We have also called
for a prohibition on conceiving a child using gametes obtained
from fetuses or derived from embryonic stem cells, or by fusing
blastomeres from two or more embryos. No child should be
able to say, "My mother or father is a fetus," "an
embryo," or a "stem cell," or that "I
come from fusions of two or more embryos."
On the embryo research question, notwithstanding our continued
deep differences, we have called for setting a limit on the
use of—a prohibition on the use of embryos in research past
a certain stage in development—again, a position that many
sides, as they presented testimony to us, said that would
make sense. And our approach here is also different from
that proposed in other countries or proposed in Congress.
We not here call for research on embryos. We do not call
for proscription of research on embryos. We simply say that
where research on embryos proceeds, it shall not proceed past
a certain stage of development.
I think that really is the gist of the recommendations.
Let me say in summary what I think are the major accomplishments,
and then I would invite members to offer their comments.
First, I think one of the great accomplishments of this
report is that this really is the first comprehensive survey
of current regulations in this area—what's going on,
whose business is it to do what, and how, what are the gaps
in what it is we would like someone to be paying attention
to, what more do we need to know in order to intelligently
advance this conversation.
Second, we've placed a highlight on the well-being of
the women in these procedures, and especially on the children
born with their aid. And as the new technologies come to
augment the existing practices, the attention to these matters
can only increase, and it would be very important to try to
beef up our—our monitoring and oversight of their well-being
Third, we have been sensible and moderate with respect to
institutional reform. This is but a first step down that
road. We have not leapt in with both feet before thinking
through carefully the implications of doing something rather
than nothing, and of doing this something rather than something
We're not shying away from that further conversation,
but we are taking this slowly and carefully as we should.
Regulation has its costs, and they have to be assessed in
Third, this is a very divided council on certain kinds of
questions. Once we get away from certain kinds of questions
I have no idea how divided we are going to be, and I'm
very much looking forward to the opportunity of moving into
some areas where it's going to be impossible to predict
what the various members around the table are going to say.
And that starts in session two this morning.
However, I think it was a wonderful idea in this project
to say, "Look, let us search for common ground. We disagree
about much, but there's much more that we might agree
about if we are willing, in fact, to look for it."
And given the polarities and divisiveness in the nation,
not only on our questions but on lots of other questions,
and given the fact that this is a council that is Democrats
and Republicans, liberals, conservatives, pro-choice, pro-life,
pro-research, scientists, humanists, theologians, that we
could show by example what could be done if one, in fact,
chooses to seek for common ground is I think a very exciting
development. And I suspect that that will get a lot of attention.
People will snipe at us for not getting everything that
they wanted out of this, but I think fair-minded people will
see, "Look what these people have done when they, in
fact, decided to look for the values that they can mutually
endorse rather than the ones about which they disagree."
Next, although we have sought common ground and achieved
some kind of unanimity—and let me not exaggerate the unanimity,
because there are people here who are nervous about some things,
and not wrongly. If you tread in the area of legislation,
even if we agree as reasonable people that these things make
sense, when they're handed over to—to the legislative
process, who knows who will jump on this with what kinds of
additional things, and that's a concern. And it's
been voiced by people here, and I share it.
Nevertheless, the agreement that we've reached here
is not a compromise. I want that to be stressed. These are
principled agreements. These are principled agreements on
the recommendations in the tenth chapter. Principled agreements—everybody is supporting these for their own principles,
but remarkably for different principles. People are on board
with these recommendations, not for the same reasons but for
very different reasons. And that's I think also not surprising,
but a very appropriate matter.
And the personal statements in this document—a great contribution—as were the personal statements in the cloning report, indicate
the multiple and different reasons why—that members of the
Council have for supporting these recommendations and for
what it is that they think the report doesn't do sufficiently
or what it thinks that it perhaps borders on too much.
But—so we have achieved unanimity not compromise, on principled
grounds, different principled grounds—we haven't, in
order to gain this unanimity, aimed at the lowest common denominator
as other attempts to gain consensus would have done. We haven't
done anything earthshaking here. This is modest, but this
is a modest but significant first step in an area where there
have not been first steps before.
No one has gotten everything that they want. We've
all gotten something I think that we care about.
Let me conclude by offering some kind of caveats, and this—these caveats are not addressed to members of the Council
as much as they are addressed really to the members of the
public, given the likelihood of misunderstanding because we
are revisiting here, especially in the recommendations, certain
things that the Council has, in fact, spoken about both in
its cloning report and its monitoring stem cell report.
Certain incomplete and, therefore, possibly misleading news
stories earlier this week written before the report's
release—have given some people the impression that the Council's
unanimity extends beyond what, in fact, it does extend to—namely, to the still contested matters of embryonic stem
cell research, federal funding, and cloning for research.
This is not the case, and I think the public should understand
this. The personal statements in this report make it perfectly
clear that we still have deep divisions in this Council about
those matters, and that the conversation will continue.
What we've tried to do in this report, to repeat, is
to develop those concrete set of proposals that people on
different sides of the embryo question can accept for their
own principled reasons, but without foreclosing the crucial
continuing argument which all of us I hope will continue to
Second, concretely on the way in which this recommendation
relates to the cloning debate in Congress and how it relates
to our own previous cloning report, because I don't want
this to be misunderstood.
When we moved again to recommend something that overlapped
with previous recommendations, I wanted it to be perfectly
clear that no one in this Council was going to be asked to
repudiate a position that they had taken previously, nor was
the Council as a whole going to repudiate its report on cloning.
We didn't revisit that to debate that question.
The proposal we are offering here is fundamentally different,
therefore, from the two cloning bans that are now before Congress.
One of them would ban the creation of cloned embryos for any
purpose whatsoever. The other will endorse research cloning
and prohibit the transfer of cloned embryos to initiate a
pregnancy, thus mandating that all cloned embryos be destroyed
at some point in the process.
This recommendation does neither of these things. It neither
prohibits the creation of cloned embryos, nor does it endorse
the creation of cloned embryos for research. On this question
our report is silent.
It does not create a class of embryos that must be destroyed.
It does not prohibit the transfer of cloned embryos were they
do exist. It does not prohibit creating cloned embryos for
research. All it asks is that it creates—it prohibits the
act of creating a cloned embryo with the intent to initiate
a pregnancy. That's all we're saying on that subject.
In the Council's—this is a clarification and a way
forward on the Council's recommendation in the cloning
report where you will recall we unanimously called for a ban
on cloning to produce children, a report—a call we here
clarify—to repeat and clarify.
On cloning for research, the majority then called for a
moratorium. The minority recommended that this practice should
proceed with recommendation. The Council has not, in this
report, changed its mind on that report.
Second and last, I don't think that there should be
misunderstanding about what the Council is saying in this
report on things touching embryo research and stem cell research.
We have called here for a moratorium on the buying and selling
and patenting of human embryos for any reason, and a moratorium
on research that uses latter-stage human embryos once they
have reached a certain stage of development. We have left
it to the Congress to settle that between 10 or 14 days.
Regarding embryo research in earlier stages, and federal
funding of such research, those stages where embryonic stem
cells are derived, the nation and the Council, alas, are still
divided. Some members continue to believe that all embryo
research should be restricted or banned; other members believe
that it should be encouraged, accelerated, and federally funded
much more than it now is.
What we agree on is only what we've got here—namely,
that research on embryos at a later stage is either wrong
or imprudent, at least for the time being, and should be placed
under a moratorium. In calling for this prohibition for the
time being, the Council neither endorses federal funding for
embryo research nor opposes it, nor does it propose limitations
on research conducted with the very early stage embryos.
On those contested matters this report and this Council
is still silent. We are calling only for a restriction of
the practice that everyone believes should, for the time being,
be restricted. I think with these important clarifications,
because there is a great deal of danger of misunderstanding,
lots of people on various sides hoping to make use of this,
I think we should simply say we've agreed on certain things.
I'm delighted that we have. I wish it was possible to
agree on more, but the society is divided on those things.
We will take a respite from those arguments here in the
Council, but that is where we stand.
I think that's both too much and too little, but that's
all I would like to say on behalf of the report as a whole,
and then placing my own particular emphasis on what I think
are our achievements, and try to correct some likely misunderstandings
that have already produced a flurry of phone calls to the
office saying, "You did what?"
So there it is, and the floor is open for discussion. Before
I ask for individual members who have asked to make comments,
are there any questions to me in terms of what I've just
said? Well, that's it.
Good. Well, I have a list of people who have asked to make
comments. And, Frank, since you are the founding father of
this venture, even if it hasn't produced quite the child
yet in full maturity that you had hoped for, perhaps you would
be willing to lead off. Frank Fukuyama.
PROFESSOR FUKUYAMA: All right. Thank you very much,
Leon. I am in fact extremely happy with the publication of
the Reproduction and Responsibility report. I want
to thank the staff of the Council for its assiduous, you know,
pursuit of this issue. And I think that the result, for all
of the reasons that Leon just laid out, is something that
we can all be quite proud of. And let me also thank the other
members of the Council for working together to agree on it.
I think that since it's a relatively short statement
I'm simply—and since Professor Wilson has also signed
on to this, I will simply read the personal statement that
I have written, because I don't want to put words in Jim's
We believe that the Reproduction and Responsibility
report is a very important document that articulates
a broad, moral consensus over the limits that our society
should place on new reproductive procedures that are now made
possible by technology. Proposed legislation, if passed,
would ban certain clearly unacceptable techniques, including
reproductive cloning, while at the same time neither prohibiting
nor condoning research cloning or other forms of embryo research.
As such, it shows a way to get past the current deadlock
that leaves the United States as one of the few developed
countries without guidelines in this area, and I think that's
an important point to stress.
Appropriate as these guidelines are, however, we believe
that they represent only a first step towards a more complete
regulatory approach needed to deal with these new technologies.
Today we can foresee possibilities like reproductive cloning
or human-animal hybrids that should be banned, but the technology
will move quickly and in the future pose ethical challenges
as well as scientific and medical opportunities that we have
not today imagined.
It would be difficult and inappropriate for Congress to
intervene seriatim as these developments occur. What is called
for instead is a modernization of our existing regulatory
structure to allow it to respond with flexibility in such
cases, taking into account not simply the safety and efficacy
of the new procedures but ethical concerns that would be widely
shared in our society.
Our hope is that the current report will represent not a
final word on the subject of the legislative limits but a
beginning of a broader discussion of regulatory oversight
of new reproductive technologies. As a general rule, we do
not welcome government intrusion into scientific inquiry and
into the reproductive choices made by parents.
But regulation frequently facilitates scientific advance
and individual choice by reassuring the public that it is
being done responsibly. That is the light in which the current
report should be seen as well as hope for future efforts to
update and modernize our regulatory system.
Then, I would simply add in my own name. I have been working
independently through a study group to, you know, look at
further measures. I think at this point it is really not
clear when you talk about the modernization of a regulatory
system what that involves, whether you need actually new institutional
powers, whether the existing institutions can actually be
modified in one way or another to do that.
But I do think that we are at a juncture where we need to
consider this further. So I do hope that—that this, as
I said in the statement, will not be the last word on this
subject. And I also would like to, again, stress the point
that regulation is not in this instance an obstacle, I believe,
to further scientific research.
I think that as in the case of biomedical technology more
generally, regulation is a—is something that actually promotes
the possibility of future research by making sure that people
understand that it is being, in fact, done safely and responsibly.
And I hope that people will take all of this in that light.
CHAIRMAN KASS: Michael Gazzaniga?
DR. GAZZANIGA: Well, there's going to be a certain
redundancy to these messages. And what I would like to offer
here has already been said as part of the record. It's
not—it's my earlier thoughts on this enterprise, and
so there are no surprises here that I have really never been
happy with this effort since it was launched. And the final
report continues, really, to leave me unsatisfied.
While drafts of this report have been freely available for
almost a year on the web, and while they have been updated
and revised as we all know, and we have certainly extensively
discussed these comments—all of this material at these meetings,
I have never felt comfortable with the thrust.
This is despite the fact that a few of us, in addition to
the time spent at these meetings, have spent many, many hours
reading it, suggesting changes to its language, and yet I
get the sense of—I was going to try some French here, but
the more things change the more they stay the same. But I
never did well in French, so I won't give you the translation.
Somehow this report starts out examining the regulatory
atmospheres of various reproductive technologies and concludes
with a set of recommendations that really have a newsworthiness.
And, as Leon has just pointed out, on this cloning issue the
objective stated time and again is to frame a set of recommendations
that would break the logjam in Congress on the issue of cloning.
This is achieved in the present document by suggesting we
outlaw any other means of making a baby except by the union
of egg and sperm, whether it be through normal sexual activities
or through IVF technologies. At this point in human history,
this is certainly fine with me.
The report also recommends any research use of leftover
embryos from IVF has to be completed by 14 days, and that,
too, is fine. What is not said, however, and as Leon has
alluded, so this is the redundancy here of the message and
is left open, is whether or not federal funding can be used
to study those leftover embryos, or clumps of cells as I would
prefer to call them. They would serve as a rich source, as
we all know, for stem cell research.
It is also not stated that somatic cell nuclear transfer
procedures—so crucial for therapeutic cloning—could go
forward with federal funding. Sometimes I think we have the
sort of cloning version here of the "Don't Ask, Don't
Tell." I say again, let's be explicit, and that's
what my difference here is I'm drawing—is I think we
should move forward to being explicit on these important issues.
And, finally, this Council has been through the issue before—these issues before, as you all know. The one time we did
vote on anything in the Council, in 2002, the majority of
us voted—10 to seven—to reject an outright ban on biomedical
cloning. Ten of us had no ethical objections in principle
to biomedical cloning. Of that majority, three major—three
members wanted to, nonetheless, have a moratorium until regulations
were in place.
I now think we are moving towards having those recommendations
in place, and I hope and assume that these Councilors will
soon be ready to move forward and support federal funding
of biomedical cloning.
CHAIRMAN KASS: Thank you very much, Mike.
I have Alfonso Gómez-Lobo next, please.
DR. GÓMEZ-LOBO: Thank you. Now,
the specific reasons I had to endorse the report are really
spelled out in the two additional statements to which I added
my signature, so I won't repeat those.
Now, what I'd like to do in this very brief statement
is, on the one hand, again call attention to the cultural
and deep background against which we are addressing these
things, and then I'll move to the specific recommendations.
In my view—and I feel very strongly that because of my
professional background I may be called to insist on this
in this Council—from my perspective, I view our culture
as moving at a swift pace towards the radical instrumentalization
and exploitation of early human life.
We're going by incremental steps, and early human life
I think is, of course, an expression that refers to human
beings who find themselves at a stage at which we all found
ourselves at the beginning of our own lives. We all started
as a one-celled organism and grew to be what we are today—namely, the same organism but with millions of cells. And
I am, of course, always willing to rediscuss the question
of identity through time.
But one of the consequences of that is that if we deserve
protection today, we deserved equal protection then. Of course,
I could expand this argument for hours.
However, in my view, going now to the recommendations, the
document we are unveiling today is a minimalist document.
The recommendations in the closing section of the report should
be understood, in my view, as minimal protections, as the
least we should do.
It seems to me that the transfer of a human embryo into
the body of a member of a non-human species, the production
of a human-animal hybrid, if it works, the buying and selling
of human embryos, the patenting of whole human organisms,
are all activities that reasonable people should reject as
basic violations of our dignity. That is, as forms of instrumentalization.
I think that's basically what dignity means here.
The report also seeks minimally to restrict destructive
or harmful experimentation after a certain period in the life
of an embryo, because at present those legal restrictions
simply do not exist. We make no recommendation, however—and Leon has insisted on this—on what should be permissible
or impermissible during the first few days of life, nor is
there any recommendation with regard to federal funding.
In fact, I join many Americans in thinking that destructive
or harmful experimentation on human embryos, either produced
by cloning or by union of the gametes, should be prohibited
altogether. The Dickey Amendment, of course, is I think,
again, the minimal we could do.
If enacted, the recommendations of this report would raise
a very basic fence in front of activities that are, I think,
deeply dehumanizing, and I'm glad we could all agree on
CHAIRMAN KASS: Thank you very much.
Rebecca? Rebecca Dresser.
PROFESSOR DRESSER: This report responds to a significant
information gap. More information is needed on ART outcomes.
Few people would argue against the position that novel ART
interventions should be evaluated according to the criteria
used to evaluate other novel biomedical interventions, and
that is safety and efficacy.
Yet a combination of circumstances has produced relatively
weak oversight for ART. Because the NIH and other federal
agencies rarely support research relevant to ART, innovative
approaches may be tried in patients without prior scientific
or research ethics review.
Because novel ART procedures are ordinarily not subject
to the FDA approval process that governs drugs and other medical
products, ART procedures may be offered and performed without
meeting the agency's safety and efficacy standards. Because
insurance coverage for ART is limited, insurance company demands
for properly qualified practitioners and adequate facilities
have less impact on the quality of care than they do in other
medical areas. And because causation, negligence, and harm
can be difficult to detect, much less to prove, the tort system
is ineffective in deterring substandard practice.
Now, the profession I think has made an important and significant
effort to assess its methods and encourage ethical practice
by clinicians, but more is needed. There is a professional
medical duty to make reasonable efforts to discover risks
associated with interventions that are offered to patients.
Fulfilling this duty is also in the profession's self-interest,
for careful evaluation of ART interventions will lessen clinicians'
exposure to liability for any alleged harm related to the
And there is also a broader social interest in learning
more about the effects of ART—for example, in learning more
about the possible health effects in children born after the
use of these interventions, and in learning more about the
health of the women undergoing superovulation, either as part
of their own treatment or to provide oocytes to others.
Now, if researchers are going to increasingly seek human
oocytes for research purposes, such as to create embryos through
cloning or IVF to serve as sources of embryonic stem cells,
more women are going to be exposed to these high doses of
hormones and to other parts of the oocyte retrieval procedure.
We really need to find out whether there are any long-term
consequences of oocyte retrieval. At minimum, we ought to
have solid information about risks to give to women who are
thinking about undergoing this procedure. And at a broader
level, we should have this information when decisions are
made about whether the potential knowledge gains generated
through creating research embryos would justify the harms
it could produce.
Finally, the legislative recommendations the Council endorses
in this report are narrow and are designed to shift the burden
to those proposing certain questionable practices. These
recommendations seek to change the U.S. status quo from one
in which individuals seeking to engage in such practices have
no obligation to explain or give reasons for proceeding, to
one in which such individuals would be required to make their
case—that is, to give reasons that a substantial portion
of the community would accept as justifications for going
This kind of a shift would place the United States with
many other developed nations engaged in ART and embryo research
where researchers and infertility specialists proposing novel
investigations or procedures must establish an appropriate
basis for doing so.
Our constitution establishes a very general framework for
decisions about reproduction and research, but leaves most
of the issues discussed in this report to be resolved through
the democratic process. People dissatisfied with the present
U.S. situation, whether they are dissatisfied with the absence
of constraints on embryo research and ART practice in the
private sector, or dissatisfied with the absence of federal
support for research involving embryos, or dissatisfied with
the lack of attention to potential social effects of increased
control over children born through ART—all of these people
face a choice.
Those who insist on securing every change they desire will
reduce the chance of securing any change. A more fruitful
alternative is to sit down with those who see things differently
and to try to craft policies reflecting points of agreement.
In developing this report, the Council chose the second
path. I hope those considering our recommendations will choose
this path as well.
CHAIRMAN KASS: Thank you, Rebecca.
PROFESSOR MEILAENDER: To gestate and give birth
to this report has been for us considerable labor. It is,
I believe, a small beginning at thinking about some very difficult
topics, difficult morally but also difficult in terms of the
everyday life of many people.
Biotechnologies touching the beginnings of human life have,
for the most part, simply grown up around us. Not without
thought, to be sure, but largely without the kind of thought
that gives direction and sets limits.
It is not hard to praise their benefits, and it is not hard
to bemoan their effects on our understanding of parenthood
and childhood. But it is very hard to say what, if anything,
we ought to do or might be able to agree to do, given the
circumstances in which we now find ourselves.
This report at least gives us a developed context in which
to think about such questions. It makes clear our need for
further information, though I'm not confident that the
information for which we call will provide all we need to
know, in particular sufficient information about the condition
of children born with the aid of IVF or detailed information
about the numbers of embryos produced for our reproductive
purposes but never brought to live birth. So this is a very
The report does, however, move beyond calls for information
and conclude with some recommendations for interim legislation,
recommendations on which we have been able to reach consensus
despite our disagreements on a variety of related issues.
The problem with consensus, of course, is that it can often
be too cute by far, blurring rather than clarifying important
disagreements. And that will certainly be the case if we
do not keep faith with each other about the nature of the
agreement we have actually achieved.
It may be useful, therefore, simply to note for the record
where these interim legislative recommendations leave us,
what we have said, and where we have been silent. With respect
to cloned embryos, the Council here says nothing that goes
beyond or qualifies what we said in our report "Human
Cloning and Human Dignity."
Hence, the majority recommendation of that report, coupling
together a ban on cloning to produce children with a four-year
moratorium on cloning for biomedical research, has not been
altered in any way and remains our majority recommendation
for legislation. We have not uncoupled those two forms of
cloning or recommended uncoupling them.
With respect to the use in research of so-called spare IVF
embryos, the Council has been able to agree only that there
should be a point in the life of an embryo at which such research
should be prohibited. We have not endorsed research prior
to that point in an embryo's life.
We have certainly not recommended government support for
research on human embryos at any point in their life, nor
do our recommendations in any way suggest that the current
prohibition on federal funding of all research that destroys
embryos should be changed.
We have not recommended a prohibition upon the implantation
of any embryo, and we have not said anything at all about
what should be done with embryos at the point where research
In the context of all those silences, we have said only
this: recognizing that there is research not governed by
the restrictions on federally funded research, we have simply
recommended that if anyone carries out research on living
human embryos there be a point at which such research must
Thus, the silences surrounding our agreements are very large
and complex. And lest good faith be replaced by duplicity
and mistrust, I hope their complexity and their largeness
will be both appreciated and honored by all of us.
CHAIRMAN KASS: Thank you.
PROFESSOR SANDEL: Thank you. Much of this
report concerns fertility clinics. But as the comments around
the table have already made clear, the two elephants in the
living room are cloning and stem cell research. A great merit
of the regulations in the report is that they point to a possible
solution to the vexed issues of cloning and stem cell research
that could overcome the current impasse in the United States
First on cloning. Despite the widespread opposition to reproductive
cloning, the Senate hasn't been able to ban it because
of disagreement about cloning for biomedical research. This
report offers an ingenious way of detaching those two questions.
It proposes that Congress prohibit attempts to conceive a
child by any means other than the union of egg and sperm.
This language provides a way for Congress to ban reproductive
cloning while agreeing to disagree on the question of cloning
for biomedical research. Congress could prohibit attempts
to create cloned children while allowing debate to continue
about cloning for stem cell research and regenerative medicine.
The proposed regulations taken together also point toward
a possible compromise on federal funding of stem cell research.
They do so by addressing at least one of the main worries
people have about stem cell research, which is the slippery
slope worry. This is the worry that without clear limits,
embryo research could lead down a slippery slope of exploitation
If we allow stem cells—stem cell research today, the argument
goes, tomorrow some people might try to transfer embryos into
a woman's uterus, or even a pig's uterus as we've
heard said, to grow organs for transplant, creating the nightmare
prospect of embryo farms, fetuses exploited for spare parts,
and the commercialization of human life.
The regulations contained in this report address that slippery
slope argument. They do so by assuring that such research
is done responsibly, within carefully prescribed limits.
No embryos used for research could be used or preserved beyond
a 10- or 14-day limit, or transferred into a woman's uterus
or into an animal's body to grow organs for harvest, nor
could embryos be bought and sold.
By assuring that stem cell research is conducted within
these limits, these regulations address the slippery slope
objection, the worry about exploitation and abuse. And so
they point the way, or so it seems to me, toward a compromise
on federal funding along the lines that were proposed back
in July of 2001 by Senator Bill Frist.
Senator Frist argued then that both embryonic and adult
stem cell research should be federally funded, but within
a carefully regulated framework, and these regulations begin
at least to create such a framework.
Now, why is this important? Well, recent scientific developments
illustrate the need to adjust federal funding policy along
the lines that Senator Frist proposed. Only 17 cell lines
are currently available on the NIH registry for federally
Just a few weeks ago, Harvard Biologist Douglas Melton announced
the creation of 17 new embryonic stem cell lines that he is
making available free of charge to scientists for non-commercial
research purposes. The Harvard stem cell lines meet all of
the criteria proposed by Senator Frist.
They were derived using private funds from blastocysts left
over from IVF clinics, not from— nothing involved with cloning—blastocysts left over that would otherwise be discarded
and with the consent of the donors. They meet all of the
And yet, under current federal policy, research on these
cell lines is ineligible for federal funding. Despite meeting
all other ethical and legal requirements, these new cell lines
were derived after 9:00 p.m. on August 9, 2001. That's
the only difference between them and the approved lines.
Now, the August 9th cutoff may have been a reasonable compromise
two and a half years ago when it was thought that some 60
or 70 cell lines would be available. But in the light of
what we know now, that August 9th cutoff looks less and less
sustainable, both practically and ethically, because whatever
one's view of the moral status of the embryo it is difficult
to understand the moral distinction between research on stem
cell lines created before 9:00 p.m. on August 9, 2001, and
research on stem cell lines created according to all of the
same ethical requirements except for the fact that they were
And so I endorse the regulations proposed in this report
in the hope that they can point the way to a national compromise
on both cloning and on federal funding of stem cell research—a compromise that will enable this country to promote the
promise of stem cell research while upholding the highest
CHAIRMAN KASS: Thank you, Michael.
I have just two more people, so that people know where we're
going. I have Robbie George and Dan Foster.
PROFESSOR GEORGE: Thank you. I wish to begin by
associating myself with the careful exposition of the content
of our report this morning that was provided by Dr. Kass.
And also, I wish to thank him for the careful clarifications
which I hope will help to prevent misunderstanding of the
report, some of which is already abroad.
I'd like to direct my comments this morning not so much
to my friends and colleagues on the Council, but broadly to
citizens who are following our deliberations, and particularly
to those citizens who share my own basic perspective on the
fundamental ethical questions having to do with embryo research.
So I ask: how ought the targeted measures proposed in Chapter
10 of the report we released today be regarded by members
of Congress and by citizens who share the belief that human
beings in every stage and condition, including the fetal and
embryonic stages, are entitled as a matter of strict justice
to full respect and legal protection?
I hope that they will be regarded as, in Dr. Kass' apt
words, significant, yet modest, steps forward. Of course
they will be regarded, and in my opinion should be regarded,
as not enough, for even if all of our recommendations were
enacted into law injustices would remain in my view.
The moral ideal and the ultimate political goal must be
full legal protection for all living members of the species
homo sapiens, all human beings, irrespective of age or size
or stage of development or condition of dependency or location.
It should never be lawful to treat a human being as a mere
property or as disposable research material or as a collection
of cells or tissues or organs to be harvested for the benefit
As Professor Gómez-Lobo and I say in our statement
attached to today's report, biomedical science should
move forward aggressively by all ethically legitimate means
in its mission of curing diseases and ameliorating suffering,
but also adding to the sum of human knowledge. Respect for
human dignity requires nothing less than this.
But the very same principle of respect for human dignity
also requires strict adherence to ethical norms protecting
the moral equality and inviolability of each human being.
It is my hope that our law and public policy will move steadily
in the direction of full respect for human dignity and protection
for human life in all stages and conditions.
The targeted measures proposed in Chapter 10 should be supported,
I believe, because they move us in the right direction. They
do not weaken or diminish any protection of nascent human
life currently in place. They do not alter the prohibition,
for example, of federal funding for destructive embryo experimentation
Their sole legal effect would be the desirable one of restricting
unethical practices which are currently unrestricted by federal
law, including some that are unfortunately encouraged by some
Today's recommendations are being proposed unanimously
by our Council. Although for some of us they are worthy of
support as important steps in the right direction, for others
they represent all or most of what should be done by way of
restricting research involving the destruction of nascent
human life. As Chairman Kass has indicated, we remain divided
on these basic moral questions.
We remain divided as a Council on the question whether all
embryo destructive research should be forbidden. We remain
divided on whether cloning to create embryos for research
should be permitted or proscribed. Today's report leaves
unaltered our recommendation on that issue contained in the
Council's report entitled "Human Cloning and Human
But these continuing divisions should not obscure the considerable
consensus we have reached. Even members favoring embryo research
agree that even privately funded research should be subject
to significant federal restrictions.
Even those who support research involving the destruction
of human embryos in the blastocyst stage agree that after
a certain point in development—10 to 14 days or fewer—the use of embryos for research involving their destruction
should be banned.
Moreover, in an important preemptive strike against the
emergence of fetus farming for transplantable tissues and
organs, the Council is united in recommending a ban on transferring
a human embryo into the body of a member of a non-human species
for any purpose or into a woman's uterus for any purpose
other than attempting to produce a live-born child.
I know that many of my fellow citizens of New Jersey, alarmed
by legislative developments in our state, will applaud the
President's Council on Bioethics for its moral leadership
in making these particular recommendations. On the other
hand, it is already clear that two of our recommendations
are being received with caution and concern by citizens who
believe in the full dignity of human beings at every stage
of development, including the embryonic stage.
The first of these is the proposed day limit on privately
funded embryo destructive research. Some people fear that
this will be perceived as an authorization of embryo destructive
research prior to the limit.
I would respectfully ask those who share this view, this
concern, to consider the points advanced by Professor Gómez-Lobo
and myself in our statement attached to today's report,
as well as those developed in the statement in which we are
joined by Professors Meilaender, Glendon, and Hurlbut.
The second point of concern has to do with the operational
definition of the proposed ban on attempts to conceive a child
by any means other than the union of sperm and egg. On this
point, the Council has attempted to find a way to preempt
development of industries that would produce children who
would be deprived of the rights and human attachments naturally
available to children conceived in vivo.
A substantial body of opinion on the Council, and which
I share, believes that the right way to proceed here is to
ban the creation of such embryos by certain processes.
For now, however, this does not appear to be feasible politically.
So our goal has been to design an approach that would provide
an effective deterrent in the face of disagreement to the
development of an unethical industry while at the same time
avoiding any suggestion of legally mandated embryo destruction
or placing limits on bona fide embryo rescue.
It's also important to note that we leave untouched
the Council's recommendation of a four-year moratorium
on the production of embryos by cloning for biomedical research,
during which time those of us favoring a permanent and complete
ban on human cloning would continue vigorously to make the
case for such a ban to state and federal legislators and to
our fellow citizens.
Whether our proposal on this particular point is a prudent
way to proceed is a legitimate question that should be reflected
on and carefully discussed by people who share the goal of
protecting human life in all stages and conditions. People
who share the foundational ethical conviction may differ in
the matter of prudential judgment, yet careful thought and
discussion may yet yield consensus.
So to those who have concerns on this point, I would respectfully
say that we should embrace those recommendations made by the
Council today, which all of us can see advance the goal of
respect for the life and dignity of the human person, while
resolving to work together in carefully thinking through the
matters on which differences of prudential judgment persist.
CHAIRMAN KASS: Thank you very much.
Dan Foster, last but by no means least.
DR. FOSTER: Well, you'd better not say that
yet. So anyway, I want to make a real-world comment, sort
of in response to Leon's earlier explanations, and not
comment on the report itself. I thought the statements were
One of the characteristics of the Council in its first two
years has been open discussion, so that there has always been
a transparency to the thoughts of the members, and that was
one of its—has been one of its great strengths. And in
that spirit, I want to acknowledge a transparent fact briefly
and without polemic.
And that fact is this: that the reconstitution of the Council
has evoked strong concern externally, especially amongst the
scientific community. The concern is that the Council has
become unbalanced. Two strong members of those who hold science
to be a high good have left and have not been replaced.
Consequent to that, some members of the Council itself have
been concerned and have conveyed that to Leon—this issue
of the perceived imbalance that I have mentioned. And I thought
it would just be crazy to have a meeting here and not acknowledge
that rea-world fact.
My colleagues would say, "What is this with all of
this going on that there's no comment about the reconstitution?"
And that's the purpose of my statement here.
I want to point out that the concerned Council members are
all here. And, further, I think it fair to say that they
think that the Council has been a good thing, and has done
good work, despite the disagreements.
Now, three quick comments, and I'm through, about how
to deal with this. First, the Chairman has always been fair
in letting issues be amply discussed in meetings. He frowns
a lot, but he has allowed ample discussion to take place.
Second—and this is to many of our scientific colleagues
who felt that those—that we should not stay on the Council.
I can tell you that there are many, many of the major scientists
in the United States who felt that the reconstitution was
such that we should not serve.
But my view is that it's almost certainly better to
have the voice for science present in future discussions than
absent, even though we're smaller in number. And that's
because science and scientific medicine is a very high good,
and most of the people in this country know that. So it's
good, I think, to those who say "leave" that we
And, third, there is always the possibility that rationality
will conquer and that Leon and the older members on the "other
side" will change their view. And I certainly assume
that as we welcome the new members to the Council we will
do everything we can to make them become more rational, too.
CHAIRMAN KASS: Charles?
DR. KRAUTHAMMER: I just wanted to make a—I have
no statement to make about the report, but I have been provoked
by Daniel, as I have been in the past many times.
DR. FOSTER: Charles, I've been provoking you
ever since I joined this Council.
DR. KRAUTHAMMER: Well, it finally worked.
I respect what you say, and I understand the sincerity and
depth from which it comes. But you talked about perceived
imbalance. We've heard about that perceived imbalance
for two years now, including the Council as composed in the
past, which we are now idealizing, and which when the Council
began two years ago was characterized in the press and elsewhere
as analogous to the Taliban, among others. So let's remember
where we started from.
I think anybody either reading this report, anybody hearing
our discussion this morning, would say that the idea of perceived
imbalance is only a perception. We have just heard from Michael
Gazzaniga a reference to the embryo as a clump of cells.
We have heard it referred to by Robbie George as the—deserving
the dignity afforded a full human being.
We have the full range of philosophical approaches on this
Commission, and I think it reflects very much the divisions
and disagreements in society itself. I believe this Council
is the most diverse, open, and reflective of any bioethics
council ever constituted in this country.
And I think the fact that we produced a report today where
we achieved unanimity despite our differences is a tribute,
a) to the sincerity and the willingness of us to work together
on common goals, and b) to the fact that in a diverse society
we can actually have ultimate agreement on basic goods.
So I understand how there is a perception about a lack of
diversity, but I don't think anybody with a fair mind,
hearing what we have heard today, reading our report, could
conclude anything except the opposite.
CHAIRMAN KASS: Thank you very much.
Thanks to all Council members. And, Dan, let me single
you out. Thank you very much for that comment. I think it
is good that the concern of the larger community is acknowledged
here, and we will continue to strive in every way possible
to make sure that every respectable opinion is heard, welcomed,
and given the full weight that it deserves.
And on the question of being able to listen to reason, the
conversation is always open, and persuasion is the ultimate
possibility, and we look forward as we move forward to new
topics to learn from one another and try to reach greater
clarity, either about what we can't agree on, but certainly
to try to find common ground as we proceed.
We have run over. I'm long-winded. Council members
are wonderfully articulate. Let me say the following. We
want to have at least—without stealing too much time for
the next session—we have a couple of people—we have five
sort of personal statements, four or five.
There are two who have asked to speak, people who have worked
very closely with us in preparing this report. Pam Madson
from the American Infertility Association, the Executive Director
there, and Erin Kramer, who is the Director of Government
Affairs from Resolve, would like to offer a comment at this
Then, we're going to have to take at least a few questions
from the press for maybe five minutes. The rest of them we
can deal with at the break. But let's at least have these
comments. I will call attention to the other press releases
that we have, so that people can read them, and I won't
take up valuable time here.
Ms. Madson, would you please come forward? And welcome
back to our gathering. It's nice to see you.
MS. MADSON: I do have a prepared statement that
is out front, but I've actually chosen not to read from
it, because if you want to read that you can read it.
First of all, I stand before you as probably one of the
most recognizable faces and voices of the infertile community,
as I have been doing this work for 15 years, and I was an
infertile person. I'm now a mother of ART children.
I want to first begin and thank you all for listening, listening
to the stakeholders that have come to you. I want to thank
you for responding to us, because the responses—and, yes,
there obviously has been division, and there has been division
even when I've been thanking you. I've been told
maybe I shouldn't thank you. So division has always been
quite present. But your staff and your chairman and all of
you have worked very, very hard to be attentive and responsive
And on behalf of the community that I represent, I do think
we feel responded to. Many things that we were extremely
unhappy with are no longer in the report, and we thank you
for that. There are wonderful things as well that we support,
that we do think is going to help the patient community—the women, the husbands. You know, we don't talk about
the husbands around this table. It's always about the
But there's actually usually two people who go in for
treatment. It's the man and the woman, and then there's
the resulting children. So for the protections for the couple
and our children, we support any help that you can give us
to get funding for prospective, balanced studies for the health
and welfare of our kids. And nobody cares more about that
than patient organizations, because we are the mothers and
the fathers of our children.
As many of you know, the American Infertility Association,
in partnership with Randt, is working to get funding for Footprints,
which will be the first prospective IVF study in children
in this country. And it will be run by stakeholders, not
by people with political agendas. All we care about is an
honest outcome, because we care about our kids.
We care about you supporting funding to help the women who
are taking known and unknown risks for the dream of a child.
We want to know what we will face later in life, and very
well nothing. Maybe something. But do we really know? No,
we don't. So thank you for supporting that.
We thank you for preserving the rights of the individual
to pursue collaborative reproduction without government interference.
We thank you for listening to us. We thank you—I have to
acknowledge Carter Snead, who has been a great ear to bring
things to the Council for us. We said, "How come you're
not talking about insurance?" And in this final report
we see mention of the importance of insurance.
And we agree with your recommendation for publicly reported
data to include the cost of ARTs to patients, as well as a
number of ART patients, in addition to the number of cycles.
We feel that this is very critical information that all patients
Do we have some issues with the report? Everybody has issues.
Everybody comes to the table with different viewpoints. And,
yes, we too have some issues and anxieties, as Dr. Kass mentioned
I think in the very beginning.
We have some issues with what we consider ambiguous language
in some of the recommendations, such as the union of egg and
sperm and creating a child. Well, does that mean we can't
do ooplasm transfer or cytoplasm transfer? What does that
I've been assured by the Council that it doesn't
mean that, but this is a political document. It's going
to travel up. Are you going to be there to explain exactly
what it means to members of Congress? I think you need—this is a pre-publication report. There's a possibility
for clarity of language. It would help everybody interpreting
your report to have a bit more clarity around some of these
Thank you for inviting me repeatedly. Thank you for listening.
Thank you for responding. And I bet that you will respond
CHAIRMAN KASS: Thank you very much, Ms. Madson.
Erin Kramer, please. Welcome back.
MS. KRAMER: Thank you so much. We also at Resolve,
the National Infertility Association, would very much like
to acknowledge the time and effort of the Council members,
the chairman, who has spent a great deal of time trying to
be responsive to the various occasions when we've expressed
concern about elements of earlier drafts, as well as the staff.
We think that there has been a great effort in at least
being responsive and trying to be clear about what is the
Council's intent in different versions. And we want to
acknowledge that you responded to our concerns about what
we originally have thought were very overly burdensome proposed
regulations of pro-pregnancy treatments. Again, that's
what we're talking about here is pro-pregnancy treatments
for these couples.
We do, however, remain concerned about some aspects of the
final report. You know, the stated intent is consumer protections.
Yes, we know that. But we feel that it may also make these
medical treatments for the infertility of infertile couples
more costly and less successful. We think that's going
to be the reality.
And we are wary of proposed governmental monitoring and
publication of all aspects of fertility treatments to a degree
that we still think is unheard of in other areas of medicine.
Our challenge, of course, is the next steps. Our challenge
is seeing this as it moves forward. And we are going to make
sure that if and when these recommendations are acted upon,
they are implemented in a manner that is fair, is unambiguous,
and is in the best interest of the millions of U.S. patients
and their children.
We are going to remain vigilant to ensure that any further
application of these recommendations does not limit access
to medically necessary infertility treatments, does not unduly
restrict the privacy of the people working so hard to build
their families, and also the privacy of their reproductive
We do applaud the Council for removing earlier recommendations
and language that we thought was very hostile to ART, and
that we thought in the end would be damaging to those seeking
medical assistance to build their family.
And we also recognize the Council for pointing out the important
need for federal funding for the studies of assisted recommendation
and also for including language in the final document that
speaks to the issue of insurance, although we still feel that
we will continue in our efforts for what we do think is the
most important consumer protection, and that is procuring
insurance coverage for those individuals working to build
CHAIRMAN KASS: Thank you very much.
Let me make an administrative decision. We have a distinguished
guest who is—we have already held—we have run 15 minutes
over our time. There are—I would be remiss if I didn't
simply mention that we have a press release from the American
Society of Reproductive Medicine and the Society for Assisted
Reproductive Technologies. They have released a statement.
This statement is available on the press table.
I was going to read it, but I will not do so. They've
been wonderful to work with, and we've learned a lot from
them, and we will continue to work with them as we will with
the patient groups.
We have a joint statement from the group Our Bodies Ourselves
jointly issued with the Center for Genetics in Society, Judy
Norsigian—and I've just lost page 2—and Marcy Darnovsky.
This statement is out there, and they are willing to be called
about this report.
And we have a statement from John Kilner from the Center
for—President for the Center of Bioethics and Human Dignity,
and a statement from Lori Andrews who has been one of our
consultants. I will not read these. These are available
to people who would like them.
In the interest of not spoiling the rest of the day, let
me simply say I will stay here through the break and be available
for questions from the press. Members of the media may also,
of course, speak to other members of the Council.
Let us take a break, and let us reconvene here at a quarter
of 11:00, so we can hear Dr. Jessell's presentation.
Apologies to those members of the press who wanted the microphone,
but I think we can try to help you get your stories written
if you speak to us individually. And I'll simply stay
This session is adjourned. We'll convene in 12 minutes.
(Whereupon, the proceedings in
the foregoing matter went off the record at 10:33 a.m. and
went back on the record at 10:52 a.m.)