Thursday, January 15, 2004
Session 1: Stem Cells: Council's Report
to the President
Release of Monitoring
Stem Cell Research: A Report of the President’s Council
CHAIRMAN KASS: The first session this morning is
devoted to officially releasing the latest council document,
our third report, a report, entitled, "Monitoring Stem
Cell Research," which council members should find at
This report to the President is offered as an update on
the state of human stem cell research, reviewing both the
science of stem cells, and the public and scholarly debates
that have arisen around it over the past several years.
We as a council have been looking at these issues and thinking
about this subject from our very beginning. The President
decided to create this council in the course of his review
and decision regarding government funding of embryonic stem
cell research, and one of the things that he asked us to do
when he created the Council was precisely to keep an eye on
this field for him and for the American public. And that
is what we have done.
We have devoted a large number of Council sessions to this
subject, at least 14 sessions by my count, beginning at our
third meeting in April of 2002. We have commissioned review
articles and heard presentations from prominent researchers
in all the various areas of human stem cell research.
We have heard from ethicists who have thought about these
issues for years. We have heard from experts in the legal
and legislative side of these questions, from people working
on the stem cell research in the private sector, and in publicly
We have heard from patient advocates, and we have heard
from the Director of the National Institutes of Health, and
the Commissioner of the Food and Drug Administration, and
many others who gave us their views and who reported on the
facts in oral and written presentations to the Council.
The staff has conducted vast reviews of the literature,
and special thanks to Lee Zwanziger for the review of the
ethics literature, and to Dick Roblin for monitoring and keeping
track of the scientific literature.
The Council's report draws on all of that, and on a great
deal of additional discussion and work by Council members
and by the council staff. It synthesizes what we have learned
through monitoring in what is essentially an update on the
present state of things more than two years after the adoption
of the administration's current policy on Federal funding
of embryonic stem cell research.
The report has gone through multiple drafts, received extensive
and painstaking comments from members, reviewed equally painstakingly
by the staff, and the scientific chapter, Chapter 4, has been
additionally reviewed for accuracy and fairness by some prominent
stem cell researchers not connected with the Council.
We are grateful to all those who have helped us in the various
phases of our work. To understand the document it is very
important to understand what I mean when I call it an update.
Because the field and the current policy are so young, this
report can be no more than an update. It summarizes some
of the more interesting and significant developments since
August 2001, both in the basic science and medical applications
of stem cell research, and in the related ethical, legal,
and policy discussions.
But it does not attempt to be a definitive or comprehensive,
or ultimate study of the whole topic. It contains no proposed
guidelines or regulations. Indeed, it contains no specific
recommendations for public policy.
That was not our task or our purpose here. Rather, it seeks
to shed light on where we are now ethically, legally, scientifically,
and medically, in order that the President, the Congress,
and the Nation, may be better informed as we all consider
where we should go in the future.
To be sure, Members of the Council do have particular views
regarding the best public policy on this subject, and there
are differences of opinion on this subject among us.
But in this report, we seek not to settle that debate, but
to improve it. The debates about this subject in the past
two years have often suffered from a great deal of confusion,
frankly, on all sides.
By offering the best available information on both the science
and the ethical arguments, gathered together in once place
and available for any interested party to consult, we hope
that this monitoring document will be able to establish a
clearer picture of the facts and the contending opinions so
as to act as the foundation for a better informed continuing
discussion of this important policy topic.
Our aim here, therefore, is in a sense limited, but it is
still a very large, extremely important one. With that as
a general preface, let me give you a short guided tour of
the document, beginning with its more specific goals.
The report has, I would say, four basic goals. First, to
explain and clarify the existing Federal policy regarding
taxpayer funding of stem cell research and its implementation.
Second, to offer an overview of the public debates surrounding
stem cell research in the past two years. Third, to provide
an update on developments in all areas of human stem cell
science in the past two years.
And finally, a kind of over- arching goal that defines for
us the entire project, to convey the moral and social importance
of the issue at hand, and to demonstrate how people of different
backgrounds, ethical beliefs, and policy preferences, can
reason together about it in a constructive and publicly responsible
And those of you who have copies may want to follow the
table of contents. I am just going to run through and highlight
a few of the important points. The report opens with a brief
introductory chapter, in which we take up some very important
questions of context, terminology and purpose.
Then in the second chapter, the report addresses — first
addresses itself to the first of the aims that I have described,
namely to describe as clearly as possible the present Federal
funding policy, its character, and its implementation.
The policy, I think it is fair to say, is founded in a desire
to promote important biomedical research without using public
funds to endorse, support, or create incentives for the future
destruction of human embryos.
The report tries to describe this aim in the context of
its history, of the history of Federal funding of embryo related
research, including the Dickey Amendment, and in the context
of what we take to be the legal, ethical, and prudential foundations
of the policy.
We also give some consideration to the unique and important
questions that surround all Federal funding decisions. What
does it mean for the government to support an activity with
What sorts of considerations should go into a funding decision,
and the Council suggests that a funding decision is always
an ethical, as well as an economic one.
Finally, in the second chapter, we try to lay out the basic
facts regarding the implementation of the Administration's
funding policy over the past two years, to explain how the
NIH has put the policy into action, and where things stand
in terms of available funding and available lines.
There has been a lot of confusion about this, and I think
it is critical to put the facts out there as fully and plainly
as possible. The basic facts on that front are that there
are 78 lines of human embryonic stem cells that have been
found to be eligible, eligible for Federal funding under the
That is, those lines were derived before the date of the
President's speech. But these lines are in different stages
of characterization and development, so that only some of
them have been developed to the point that they are actually
available to researchers who want them today.
Others are still being developed, and, of course, it is
impossible to know in advance how many of these will finally
in fact prove to be usable, the important distinction between
what is eligible and what is available.
And here we run into one of the difficulties of reporting
on a field that is constantly changing. The number of lines
available to researchers has been growing over the past two
years as more of the eligible lines have been developed and
A year ago, about five lines were available. This fall
when we were completing this report, the number had risen
to 12 lines, and so 12 is the number listed in this document.
But since that time, at the end of December, the NIH reports
that three additional lines have become available, and so
the number is now 15 lines rather than 12.
We note very clearly in the report that this number will
continue to change and so this very recent increase in the
number of actually available lines only underlines that fact,
but it does not change any of the major points made in the
document, and in the final version of this report, we will
update those facts, as well.
The funding policy, though it limits the targets of funding
to the eligible lines, does not directly delimit or restrict
the amount of money, or other resources that the NIH may invest
in human embryonic stem cell research.
The amount invested is a decision left to the NIH and the
Congressional appropriations process is largely a function
of the number of qualified applicants for funding, and of
the NIH's own priorities and funding decisions.
In Fiscal Year 2002, the NIH devoted approximately $10.7
million to human embryonic stem cell research, and based on
an estimate that we received in September of 2003, it will
have spent approximately 17 million in Fiscal Year 2003.
Still, however, only roughly ten percent of the amount spent
on adult stem cell research. This amount is expected, as
the field and the number of grant applications grow.
Having laid out the character and state of implementation
of the present funding policy, the report then turns to a
review of the public debate, which, as you all know, has been
quite active and quite contentious over the past two years.
A great deal has been written and said, and there have been
Congressional hearings on these subjects, many books and articles
published, many different sorts of arguments put forward on
all sides, and we have been monitoring these activities for
over two years.
The third chapter of this document, which is the longest
chapter, tries to offer an overview of these debates. It
makes no claim to be absolutely comprehensive, of course;
that would be more than any document like this could hope
But I do think that it describes and organizes all the major
strands of the public debate, and that it presents these in
a way that might allow people to get a sense of what the issues
are, and what the arguments are, and what there is to think
We have organized the discussion in relation to the current
policy and its moral and prudential underpinnings so that
the reader may see the way in which the ethical debate can
have practical traction regarding policy.
Subtopics include challenges to the moral aims of the current
policy, challenges to some of the internal features of the
current policy, efforts to try to cut the Gordian Knot that
is the moral standing of human embryos, and other social and
public issues less frequently discussed, but perhaps no less
As we conclude our overview of the ethical debates, strong
and powerful — and I quote from the report — strong and
powerfully argued views have been presented on various sides
of each of these questions.
For now, neither side to the debate seems close to fully
persuading the other of the truth it thinks it sees, but the
rich and growing ethical debates do suggest the possibility
of progress toward greater understanding of the issues, and
toward more important and informed public decision making
as all parties to the deliberation appreciate better just
what is at stake, not only for them or their opponents, but
indeed for all of us.
In presenting these arguments, we have tried to present
them, the arguments and the counter- arguments, faithfully
and accurately, so that each reader can judge them for himself
I should add, by the way, that some of the points and some
of the arguments described actually originated in the discussions
of this Council, and, of course, those are clearly cited in
the text, just like all of our other sources.
Finally, and, of course, absolutely crucial to any discussion
of human stem cell research, is a rigorously informed sense
of just where the science now stands, both in basic research
and in therapeutic efforts using animal models.
We have sought to offer readers of this report both an explanation
of what the science of stem cells involves, and an update
on recent developments in the current state of human stem
cell research, understanding, of course, that the field is
At the heart of this effort are seven commissioned review
articles written by leading scientists covering the published
literature as of last summer on embryonic stem cells, and
embryonic germ cells, adult stem cells, multipotent adult
progenitor cells, mesenchymal stem cells, and stem cells from
And a seventh paper on the problem of immunological rejection,
one of the obstacles to eventual successful tissue transplantation.
These papers appear unedited in their entirety, in the appendices
H through N in the report.
As an adjunct to these Commission review articles, the fourth
and final chapter in the body of the report proper seeks to
enable especially non- scientific readers to appreciate the
reasons for the excitement over stem cell research, the complexities
of working with stem cells, some early intriguing research
and therapeutic findings, and the difficult road that must
yet be traveled before we can reap therapeutic and other benefits
from this potentially highly fertile field of research.
Along with the scientific appendices and several other Commission
papers on ethics and policy that are offered as appendices,
the report also includes what we have called an embryo primer.
This is the first appendix of the document, and it offers
basic facts about human embryology that we think any reader
should know before coming to judgment about the issues that
surround human embryonic stem cell research.
The scientific facts don't simply settle the moral or policy
questions by themselves, but they are, of course, quite crucial
to any understanding and determination on that subject.
In short then, the report aims to describe the present policy
to review the social and ethical debates, and to offer an
update on scientific developments.
And these three aims, as I have said, are overached by this
desire to convey to the reader the tremendous importance of
the issues at hand, and to show that we, as a society, can
think about them together.
I think the Council's work in putting the document together
demonstrates that, too. Throughout the Council's deliberations,
and in this Monitoring Report, mostly successfully, to acknowledge
the strengths and importance of opinions and concerns held
by people with whom we personally might disagree.
We have aspired to be careful and fair in our approach,
precise in our language, accurate in presenting data in arguments,
and thoughtful in laying out the various issues that remain
These have been our aims in this document, and I would like
to think that the report achieves its aims, though that is
for the readers to judge. We do hope that this will help
to inform the very important and complicated ongoing public
I would like, in closing, simply to offer special thanks
to members of the staff who are especially responsible for
this report. Everyone had a hand in it, but Lee Zwanziger,
Dick Roblin, and Yuval Levin.
That is my synoptic view of the report. The procedure is
that there are a few members who have asked to make brief
comments on the report, and then we will open the floor to
questions from the press.
Two of our members are still in transit — actually probably
Charles as well. Elizabeth Blackburn, who cannot be with
us today, has sent in a comment which she has asked me to
read, and let me begin with that, while others who have asked
to speak will come next.
This is from Elizabeth, and I quote: From the scientific
published literature and peer review journals on stem cells,
a major message that can be distilled is the vast difference
that currently exists between embryonic and adult stem cells
as sources of material for research and clinical purposes.
Briefly stated, human stem cells have been isolated from
a variety of embryonic, fetal, and adult tissue sources.
However, enormous differences exist in purity, properties,
data reproducibility, and understanding of cells from these
different sources. Paragraph.
First, embryonic stem cells
have been extensively and rigorously demonstrated in animal
models to have great utility for scientific studies, and this
work has also shown that human embryonic stem cells, together
with fetal stem cells, show the greatest promise for clinical
As well as therapeutic uses, important additional potential
applications include studies of stem cells bearing complex
genotypes susceptible to poorly understood common human diseases,
and testing and screening throughout efficacy. Paragraph.
Second, the only well- characterized adult stem cells that exist
to date are hemopoietic stem cells. These are the only ones that
have been well characterized in multiple laboratories and are reliably
Currently, major difficulties exist with other types of
adult stem cells reported to date. Research on some of the
reported adult stem cell preparations may conceivably in the
future demonstrate that they, too, like hematopoietic stem
cells, can also be, "single cell cloned," expanded
considerably by growth in vitro with retention of normal chromosome
structure and number, and preserved by freezing and storage
at low temperatures.
But it should be strongly cautioned that this is not been
done, and even if possible, it will be technically very demanding.
Furthermore, in the case of MAPCs, and that is the multipotent
adult progenitor cells, the work of Catherine Verfaillie,
and furthermore in the case of MAPCs, for example, the reported
isolation and properties of MAPCs must be reproduced in additional
laboratories for any reliable interpretation of the results
reported with these cells.
After considerable effort this has not been achieved to
date. Thus, it remains extremely difficult to interpret these
results rigorously. Therefore, it is important to note that
in light of this failure to reproduce the reported results
as of now, the significance of the reported isolation and
properties of human MAPCs is still left unclear, as is, therefore,
their potential as a source of stem cells for clinical purposes.
Hence, a strong overall caution is that many of the reports
of the properties of cells differentiated from adult stem
cell preparations, other than hematopoietic stem cells, are,
to date, preliminary and still very incomplete. Paragraph.
If and when the results to date with any isolated and characterized
adult stem cells are validated, it will then be very important
to compare their properties, and those of any more differentiated
cells that can be derived from them with other stem cells
These sources include adult stem cells, such as the well
characterized hematopoietic stem cells, and the human embryonic
stem cell preparations that have already been more extensively
Two major considerations argue strongly for non- commercial
Federal peer- reviewed funding to be made available for this
work. The first is the sustained effort this work will require,
the second is the importance of reliable and unbiased design
of experiments, and of open public availability of the complete
findings arising from the work.
I have been told that, I think, Alfonso Gómez-Lobo has a
comment, and I believe Robby George. Alfonso, please.
DR. GÓMEZ-LOBO: Thank you. We have in our
hands a valuable document that has been carefully crafted
by our admirable staff under the guidance of Dr.Leon Kass.
The document contains illuminating presentations by the
experts we invited to instruct us on different topics. And
it also incorporates a significant number of contributions
from members of the Council who spent long hours sifting through
the successive drafts. It is, on all accounts, a significant
What I would like to do in this brief statement is to express
my own exegetical hopes, that is, my personal hopes with regard
to the way that the report will be read and understood.
My first hope is that the abundance of scientific information
and funding policy questions would not obscure the fact that
this is a report issued not by a scientific panel, but by
a council on bioethics, a body primarily expected to address
It is my hope that readers of the report will realize that
by the end of the day there is but one central ethical concern
in embryonic stem cell research, namely, that at the present
time human embryonic stem cells can only be obtained by deliberate
destruction of live human embryos.
It is my hope that readers will also realize that research
on adult, or non- embryonic stem cells, raises no equivalent
ethical concerns because no destruction of human organisms
In spite of the fact that opinions on how human embryos
should be treated are deeply divided, my hope is that the
report will not be read as espousing skepticism on whether
we can reach a rational solution to the question of when the
life of a human being begins, and when respect for that life
ought to begin.
I hope that our further scientific work in animal models
on the embryonic stage, especially on twinning, will allow
us to make better inferences on those topics, and I hope that
further conceptual work on the notion of "special respect"
and "intermediate moral status" will show whether
or not those concepts are adequate to express what we owe
to humans who find themselves at a stage we all went through
My own view is that the notion of special respect allows
us to discriminate among embryos on the basis of the circumstances
in which they have been placed, and fails to raise a protective
barrier in front of hundreds of human embryos that are genetically
no different from those that will not be used for research,
and will be allowed to further develop.
Finally, I hope that reflection on the fact that every human
being alive today went through the embryonic stage would lead
us to understand that the fruits of embryonic stem cell research
will come at the disturbing price of humanity turning against
itself. Thank you.
CHAIRMAN KASS: Robby George.
PROF. GEORGE: Thank you, Leon. Today's report
does not seek to settle the question of the justice of human
embryo destruction and the cause of biomedical research.
On that question, it sets forth the reasons why some of
us oppose the taking of human life even in the embryonic stage,
and others believe it to be justified where it is done with
the realistic hope of helping people who are afflicted with
serious illnesses and disabilities.
Nor does our report offer an evaluative judgment of the
policy put into place by the President of the United States
on August 9th, 2001, restricting Federal funding of research
involving the destruction of embryonic human life.
On this question, too, we are divided as a nation and as
a Council. The report makes a contribution, however, by clarifying
the grounds and meaning of the policy, and by providing reliable
information as to its implementation and impact.
As for the grounds of the policy, and its coherence, or
possible lack of coherence with this or that view of the moral
standing of the human embryo, and the moral permissibility
of embryo destruction and research, the report makes clear
that there are, on the Council, differences of opinion.
Again, the report does not seek to resolve these differences,
and so it should be understood that the purpose of the report
is descriptive rather than prescriptive.
It sets forth facts and it does not take positions on matters
on which the council is fundamentally divided. Those of us
who believe that a policy of funding research involving the
destruction of human embryos would be unjust share with our
colleagues a desire for stem cell science to go forward unimpeded
where research can be conducted without taking nascent human
We are heartened by the clinical successes of adult stem
cell based therapies. Such therapies are already in very
encouraging clinical trials in humans for Parkinson's disease,
multiple sclerosis, immune- deficiencies, sickle- cell anemia,
and other afflictions.
Certain adult stem cell based therapies have already enabled
some patients with Type- I diabetes to throw away their insulin
needles. While taking into account Dr. Blackburn's caution
about the so far preliminary and incomplete status of research
on multipotent adult progenitor cells, MAPCs.
We believe that promising and ethically unimpeachable research
of this kind should be encouraged and generously funded.
We do not wish the controversy over embryonic research to
mislead the public into supposing that there is something
ethically suspect about stem cell research in itself. There
There are forms of important stem cell research that Americans
can unanimously and enthusiastically support, despite our
differences on other forms.
It is important not to hype adult stem cell research, but
it is equally important not to obscure its achievements and
very considerable promise. By the same token, it is important
not to hype the benefits or promise of embryonic research.
I do not believe that the evidence supports a claim that
embryonic stem cells show the greatest promise for therapeutic
uses. The difficulty in controlling them and their tendency
to tumor formation makes them too dangerous for clinical trials
at this time.
Very recent studies suggest that embryonic cell cultures
may tend to accumulate extra chromosomes over time, the very
chromosomes associated with the formation of cancerous tumors.
These problems may or may not eventually be solved, but
plainly they need to be soberly taken into account in any
presentation of the matter. At the same time, no one would
wish to prevent or impede research if stem cells of the type
currently derived by destroying embryonic human life could
be derived without resort to embryo destruction.
The report that we issue today for the first time follows
up a possibility raised by our colleague, William Hurlbut,
in his personal statement attached to our earlier report on
Today's report suggests the possibility, the possibility,
of deriving cells from entities whose initial properties in
certain ways resemble those of living human embryos, but whose
direction of growth and trajectory of development due to epigenetic
differences are quite distinct.
Such entities, roughly analogous to hydatidiform moles or
other disorder growths sometimes appearing in nature would
not qualify as whole living members of the human species,
or the species, homo sapiens.
On no one's account would they be considered embryonic human
beings. If in fact these entities were capable of yielding
embryonic type stem cells, these stem cells could be harvested
without raising the ethical issue of embryo destruction.
Whether entities thus envisaged can be produced is a matter
of fact that I think should be explored. Whether their production
would raise ethical questions that perhaps Dr. Hurlbut and
I have not considered, others have to say.
But given the ethical impasse in the country and on the
council on the issue of embryo research, I am glad that our
report today elevates the profile of Dr. Hurlbut's proposal.
I commend him for seeking to address a vexing and divisive
issue with a creative solution that would honor the concerns
of reasonable people of good will across the spectrum of opinions.
CHAIRMAN KASS: That was all I knew of people who
had asked for comment in advance. If I am correct on that,
then I don't know that we have members of the press here that
would like to ask comments or ask questions about the report.
We have a microphone which is over to the side. Could we
have that moved more centrally. Are there any questions?
Please, for the transcript, would you mind stating your name,
and if there is an identification that goes with it, it would
MR. OTTO: Yes, I am Alexander Otto, and I write
for the Bureau of National Affairs Medical Research, Law,
and Policy Report. Recently, New Jersey just passed a
law explicitly making legal research on embryonic stem cell
derived from human cloning.
It follows California's similar action of a few years ago,
and, of course, bills are pending in other states to do the
same thing. How does this state action affect the debate
on the Federal level?
It is a very general question, but I would like to see it
addressed by the panel, if possible. Thank you.
CHAIRMAN KASS: This is not a question about our
MR. OTTO: Right. It is not. It is more a general
question, if you could address it.
CHAIRMAN KASS: Well, I am sort of two minds, and
one could say that this would be a lengthy off- the- subject
topic that we probably shouldn't go into. On the other hand,
we don't often get questions from the floor, and maybe a sentence
or two wouldn't be out of order, and if I get it wrong, my
colleagues will correct me.
There is no law in the United States forbidding stem cell
research or research on human cloning at the present time.
Those state laws are in a certain way gratuitous.
They are simply declaring not so much that certain kinds
of things are legal there. Those things were legal there
before. They have given sort of the state blessings and announce
that this state is in favor of those things in an affirmative
Not unless and until there would be a national policy that
would declare some of those things illegal would there be
any kind of conflict between those state laws and what transpires
at the Federal level.
The Federal question, at the moment, here is a question
of Federal funding and the funding policy. There is no ban
on any kind of embryonic stem cell research at the Federal
So, I mean, there are different dispositions at work in
these States, and in the Congressional debate, but I don't
think — I think I am right in saying that there is absolutely
no conflict at all. My learned legal counsel.
PROF. GEORGE: I just would enter one caveat
about that. I don't think it is quite right to say that there
is no law in the United States restricting those kinds of
research. I believe that there are some state laws that go
in the opposite direction —
CHAIRMAN KASS: No, I understand, but there is no
Federal law. Excuse me. The states are free to be more restrictive,
PROF. FOSTER: Well, let me just make a brief comment,
and I can only talk from the state of Texas where I am. The driving
force for the states has to do with economics.
Everybody in the world wants to have biotechnology in their
state, and the companies, the economic impact of not saying
that a state will support this type of activity is extremely
powerful, even in a conservative state like Texas.
In fact, I was at a two-day conference just this last week about
this issue after the new state decision. So I think that the driving
force there is independent of what we do here, but it powerfully
I mean, the big states are going to be terrifically hurt
if their idea has to do with — you know, no company will
come, and no graduate students, or a few graduate students
will come to the universities and so forth if you don't do
That is the concern, and I think it is the first thing.
The other thing that I mentioned that is not in the report
is that at one point there have been five appellate court
decisions about the nature of stored embryos.
So, there are legal decisions, mostly in divorce cases,
in which the courts have — and including very high courts,
and I guess maybe the highest court in New York, and in Tennessee,
that have basically decided that the embryo is deserving of
special respect, I understand, Alfonso, that that term is
But have basically decided in terms of contracts and so
forth that the stored embryos are to be dealt with like other
property in a divorce if I understand that. That is what
legal people tell me the decision is.
So, all I am trying to say is that there are a lot of other
things going on that are outside the ethical issues that we
are talking about here.
CHAIRMAN KASS: Thank you very much. Cynthia Cohen,
MS. COHEN: I am Cynthia Cohen, and I work at the
Kennedy Institute of Ethics at Georgetown. I am a philosopher
and a lawyer by training. I was interested in the fact that
the Council is not coming out with any new guidelines and
The second charge that you have on page one here is not
only to monitor stem cell research, but to recommend appropriate
guidelines and regulations. And you mentioned that you have
not had that much time, that this is still a growing field,
that there is a difference of opinion on the Council about
But, I wondered whether, for instance why there is no recommendation
for an oversight body as there is in Canada. I have just
been appointed to the Canadian Ethics Oversight Committee.
CHAIRMAN KASS: Good.
MS. COHEN: And they are concerned about doing a
strictly ethical review of their stem cell research. In the
United States the NIH is in charge of review, and it is primarily
a scientific review.
There was a mention of some of the economic concerns that
are arising. As stem cell research spreads, patenting issues,
questions about what is going on in the private sector, I
think you would have recommendations about that.
So I am just puzzled, and I hope that you can help me to
explain this to readers of the journal when I write this meeting
up. Thank you.
CHAIRMAN KASS: Well, thank you. I guess there is
several parts of an answer to that question. I think the
primary answer is that this field is young. The current policy
is very young. The implementation of that policy moves slowly,
although the NIH has made it very clear, and the evidence
is considerable, that they have strained every nerve to get
this thing up and running as fast as possible.
And it seemed to us premature to jump in and second guess
the current arrangements before one has given them even a
couple of years time to work. Stem cells, human stem cells,
isolation, embryonic stem cells, the first isolation reported
The announcement of the new funding policy in August of
2001. The lines just becoming available, and the funding
sources just increasing. The research only beginning to be
It seemed premature to, at this time, to do more than simply
monitor and report what has been going on. Down the road,
we might very well revisit this after there has been more
experience and more opportunity to see whether things are
working, and what else needs to be done. That would be part
of the answer.
The other part of the answer is that the Council is interested
in the larger question of oversight, monitoring and regulation
of biotechnologies, and we have another project.
And, in fact, the subject of the second session this morning,
biotechnology and public policy, an investigation of those
technologies that touch the beginnings of human life.
And I don't want to preempt the discussion of that topic,
but there have been serious considerations about the possible
need for new institutional mechanisms to oversee these matters,
and to monitor them, and then perhaps to regulate them.
I think it is fair to say that the Council on that subject
is not yet in the position to make institutional recommendations
so that we will be producing some kind of diagnostic document,
with some interim recommendations.
But the larger subject that you ask about is pretty much
on our minds, but we wouldn't think of isolating it just to
the question of stem cells. I think that would be kind of
a two- part answer.
PROF. MEILAENDER: Leon, could I just make one
comment, in response to that?
CHAIRMAN KASS: Yes, Gil.
PROF. MEILAENDER: It's not as if we have made
no recommendations either. I mean, you have to remember that
the first thing that we produced was a document on human cloning
and human dignity, which though somewhat different, certainly
is related to this general topic, and embroiled thus in aspects
of this topic.
And we had recommendations, certain kinds of policy recommendations
there, but majority and minority views. So, you have to read this
in conjunction with our other work, I think.
CHAIRMAN KASS: Yes, and there, however, the question
was that there was a particular legislative debate into which
we were pitted. And here — and there was — and here we
enter with a request to monitor the goings on under the current
policy as announced.
So that the situation is — I mean, I think Gil is right,
but the situations are not exactly the same. Please.
MS. FRIEDMAN: I am Joyce Frieden, and I write for
Ob-Gyn News. You mentioned in your introduction that
I think that 78 stem cell lines, I think, was the number that
were available, and I just wanted —
CHAIRMAN KASS: No, that were eligible.
MS. FRIEDEN: That were eligible for funding. I
just want to make sure that is the upper limit, and if you
have any idea if any of those 15 that you said were currently
available, and what you think the eventual number is.
CHAIRMAN KASS: There is no way to know how many
of these — let me repeat. Eligibility is defined by the
announcement of — when the President made his announcement
that there would be funding for lines already in existence
as of the date of the announcement.
And we have got some discussions and I don't want to rehearse
the details of the policy, but to be eligible the embryonic
stem cell line had already to have been derived and the destructive — the embryonic destructive act had already to have taken
Before — and let's say in the spring or the winter of
the year 2001, the loose estimates were that maybe there were
20 such lines existing world- wide, and while the President
was deliberating about that policy, people at the NIH were
And if I am not mistaken, when the policy was announced,
it was something like they thought there were 64 such eligible
lines. Further research revealed that there were now, I think — that there are now 78.
And who knows whether there is somebody who is harboring
something someplace else that is eligible, but that is not
the important question. The important question, really, is
how many of these eligible lines becomes sufficiently well
developed, sufficiently well characterized, that the material
transfer agreements are reached so that these become available
to scientists for use.
The NIH monitors this carefully and it keeps a register
of all of the eligible lines, and which ones then become available,
and there are now, as of the end December, 15 such lines listed
by the NIH. The additional three lines coming one from Wisconsin,
and two from Technion University in Israel.
But the NIH has a website for this, and they keep this information
MS. FRIEDEN: Thank you.
CHAIRMAN KASS: And by the way, no one knows — it would just be fruitless to speculate in advance how many
of the remaining 63 lines will become available. Further
CHAIRMAN KASS: Let's take an earlier break and convene
at, say, five after 10:00 to get started on the second session,
rather than just sit. Thank you very much.
(Whereupon, at 9:44 a.m., the meeting was recessed
and resumed at 10:22 a.m.)