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1/26/1999 -- Copyright (C) 1999 by Federal Information Systems Corporation
Senate Appropriations Cmte Hearing - Q&A: Harold Varmus, NIH, and Eric
Meslin, Nat'l Bioethics Commission ~ Brain Stem Research (Transcript
990260161, 935 Lines]

HEARING OF THE LABOR, HEALTH AND HUMAN SERVICES AND EDUCATION
SUBCOMMITTEE OF THE SENATE APPROPRIATIONS COMMITTEE
SUBJECT: EMBRYONIC STEM CELL RESEARCH
CHAIRED BY: SENATOR ARLEN SPECTER (R-PA)
WITNESSES: HAROLD VARMUS, DIRECTOR,
NATIONAL INSTITUTES OF HEALTH
ERIC M. MESLIN, EXECUTIVE DIRECTOR,
NATIONAL BIOETHICS ADVISORY COMMISSION
138 DIRKSEN SENATE OFFICE BUILDING
WASHINGTON, DC
9:30 AM.

TUESDAY, JANUARY 26, 1999

SEN. ARLEN SPECTOR (R-PA): Morning ladies and gentlemen.

The Subcommittee on Labor, Health, Human Services and Education
will proceed. We have scheduled this hearing on stem cells, which is
the third in reasonably rapid succession, giving the hearing schedules
of the subcommittee, this subcommittee or any subcommittee.

Because of the importance of stem cell research where there is
such enormous potential for medical advances, the request has been
made that the subcommittee not proceed to initiate legislation on the
subject because that might complicate the use of stem cells under an
opinion, which has just been rendered by legal counsel for the
Department of Health and Human Services and we want to work with HHS
and NIH to see to it that the most appropriate course is followed
here.

The definition of organisms and stem cells and the entire medical
lexicon is extraordinarily complicated. We have noted that NIH
researchers will only be allowed to work on stem cells obtained by

private sources. No NIH supported researchers will be allowed to
conduct direct work on a human embryo, even to obtain stem cells
consistent with the existing ban. That is an advance, but it's

limited, obviously on the face, and there are a series of NIH caveats,
in that NIH will not fund any human cell research until such time as
special guidelines are developed, addressing relevant, ethical and
moral issues. So that is a constraint and NIH plans to convene a
special oversight group to review all research grant applications
involving human stem cells in addition to regular scientific review
process, which is another limitation.

And then NIH has asked the National Bioethics Advisory Board for
additional guidance and I appreciate the thinking of NIH on all these
very complex subjects and the hearing today will focus on to what
extent that may delay the research. And there's a question as to
whether additional legislation is needed, which we will be addressing
and these are very, very difficult legal problems and that only begins
to scratch the surface of the ethical problems, which underlie them.
And the question is in my mind as to whether legislation is necessary
or desirable. Maybe we shouldn't have any legislation.
My preliminary thinking is, as I expressed it in the second
hearing, after studying the issue from our initial hearing, was that
we really ought to utilize this kind of research and if it requires
legislative change, then I think we ought to proceed in a expeditious
way, but in a careful way. So Dr. Varmus, that's a very, very brief
outline of some of the problems running through my thinking on it.

We welcome you here, again, today. I know that there's
scheduling problems among the panel and there is a scheduling problem
with the subcommittee. We've advanced the hearing, as you know, to
9:00 because we have a caucus on the impeachment case, which is a very
time consuming, but it is my firm view that we ought to be taking care

of other problems as well. So whatever time we have to meet to do
that or however we can proceed in an appropriate, but expedited
fashion, we intend to do that. And I know you're experienced at it,

Dr. Varmus.

So we thank you for coming. We compliment you again on the
outstanding work you have done at NIH over the years and we have put
the government's money where our praise is to paraphrase a famous
statement.

The floor is yours, Dr. Varmus.

DR. HAROLD VARMUS: Mr. Chairman, thank you very much.

SEN. SPECTOR: I'd like you to limit the opening statements to
five minutes to leave maximum time for questions.

DR. VARMUS: I appreciate your attention to these issues, despite
your complex conflicting demands on your time.

Our purpose today is threefold. I'm going to just say a couple
of words to remind you about the scientific prospects here, review the
legal decision that you've alluded to and outline the next steps the
NI proposes to take to pursue our intention to support research with
these new stem cells. I'll remind you that human pluripotent stem
cells were recently isolated by two methods. First, from fetal tissue
after an elective abortion and from embryos that were donated after
successful treatment of infertility. Neither of these events were
supported with federal funding.

Now, human pluripotent stem cells can divide and culture for long
periods. That's part of their usefulness -- good morning, Senator --
and have the potential to form virtually any kind of tissue. The
research application of these cells are various and important. They
include attempts to understand human development, efforts to develop
drugs and tests for drug toxicity in new ways and the potential for
developing cell therapies for many diseases, injuries and conditions.

We discussed in December, at your hearings, the issue of federal
support for this science and, indeed, other kinds of science as well.
And as you heard from the panelists, at that time, there are several
advantages to receiving federal support in this area, the open
exchange and the more intense and accountable oversight, the greater
number of dollars and the more talent recruited to these problems and
the ultimate, faster progress toward public health goals.

We at the NIH respect and recognize many ethical and legal
concerns about human pluripotent stem cells and the modes by which
they are derived. And we are firm in our conviction that federal
funds should not be used for this purpose until both the legal
concerns and these ethical concerns have been addressed and many
constituencies, including Congress and the public have been consulted.
As a first step, I asked the general counsel, Harriet Rabb, who's
sitting with me today, for a legal opinion about the federal funding
of research with these cells, distinguishing carefully between the use
of the cells and their derivation. In other words, can we support work
with the established human pluripotent stem cells in view of the
appropriation law that you alluded to that bans the use of federal
funds for embryo research?

The essence of her opinion, which you have been given, is that
first, yes, we can fund work with human pluripotent stem cells derived
from non-living fetuses under the existing statutes that govern fetal
tissue research. Secondly, we can fund work with human pluripotent
stem cells that are derived from embryos because the cells themselves
are not organisms. They cannot become organisms and hence they are not
embryos as defined by law and indeed, at your December hearing,
prompted by Senator Harkin, all witnesses agreed with this definition.
Now under the appropriation law, it's also the case that we
cannot use these stem cells to make an embryo, for example, by somatic
cell nuclear transfer and of course we cannot fund work to derive such
cells from embryos, although we can do so from fetal tissue. Now I
presented these views at a meeting of the National Biologic Advisory
Commission on January 19th. That meeting was held on this topic in
response to a presidential request that the entire area of stem cell
research be reviewed in view of the promises of recent work because he
felt that recent advances had indicated that there was a need to
reassess the balance between the ethical concerns about such work and
the promise for medical research. We welcomed the review by NBAC. We
specifically seek prompt guidance with respect to the ethical
considerations that will allow us to carry out appropriate oversight
on this research.

But what are our next steps? Well first, as I've made clear on
Many occasions, no immediate funding is occurring until we have our
guidelines and process in place. This has been communicated to all of
our investigators, both intramurally and extramurally through memos
and Internet postings and news reports. Secondly, I am establishing a
subcommittee of my advisory committee to the director, which has ad
hoc members from all the relevant specialties. That subcommittee will
work with NIH staff to compose guidelines for the conduct of research
on these cells. The guidelines will address the work to be done with
the cells, how the cells were derived and how the starting materials
were obtained.

There are important frameworks that will make this formulation of
guidelines easier. There are federal rules for work with fetal tissue
that will be helpful and some years ago, in 1994, a human embryo
research panel issued recommendations that were extremely thoughtful
and will be important guides in the development of guidelines.
Finally, the group will also be consulting with the NBAC, with
Congress, with the public. We will be publishing a draft of our
guidelines in the Federal Register for comment. We expect to have the
guidelines written and presented to the public in the course of the
next couple of months.

We will then promulgate those guidelines and then in a manner to be
determined by the working subcommittee and oversight group we'll
ensure that all who do this work are actually in compliance with the
guidelines.

We expect that the vast majority of applications will be mostly
routine, that is, they will be applications to work with the existing
cells that have been described and whose providence is well
understood.

Any uncertainties will be referred to further public discussion,
and we will carry out annual reporting to Congress and the public
about the status of the science, the number of investigators and any
change proposed for the guidelines. Now, before I conclude these
remarks, let me just make a personal comment, that since I made my
presentation to NBAC last week, my staff and I have received many,
many thoughtful, interesting, perplexing questions. Let me just
address two of those that I think will help inform our discussion.

First, we've been asked, isn't working with these stem cells like
using stolen goods, because some of them are derived from embryos and

that embryo research is forbidden. No, no. It is not illegal to
derive human pluripotent stem cells. What is forbidden is the use of
federal funds to derive them from embryos. In this sense, it's like

many legal activities which federal funding is not permitted. No
federal funds were used, no laws were broken in producing these stem
cells, and we have determined that no laws would be broken if federal
funds are used to support work with them, once they have been derived.
The second question we frequently hear is, won't federal funding
for human pluripotent stem cells create a demand to create additional
human embryos? Again, the answer is no. There are thousands of
embryos, indeed, probably tens of thousands of embryos that are frozen
and discarded in US in vitro fertilization clinics each year, because
they are in excess of the number required from successful treatment of
infertility. In contrast, human pluripotent stem cells derived from
very few embryos can be used by many investigators for hundreds of
experiments because it's usually possible to keep these cells growing
for many generations, as for many cell doublings.

Furthermore, federal guidelines that protect against coercion and
the procurement of fetal tissue are likely to be emulated in the
construction of our guidelines for work with human pluripotent stem
cells. Mr. Chairman, no doubt you and Senator Harkin have other
questions. I'd be pleased to answer them now.

Thank you very much.

SEN. SPECTER: Thank you very much, Dr. Varmus.

Before yielding to my distinguished colleague, we're going to
turn to Dr. Rabb. We appreciate your being here, Dr. Rabb. You
served as general counsel for the Department of Health and Human
Services since May of 1993, very substantial tenure, former director
of the clinical education of Columbia Law School, vice-dean of the Law
Faculty in 1992. We appreciate your joining us and the floor is yours,
Dr. Rabb.

DR. HARRIET RABB: Thank you.

Thank you, Senator. I wanted to spend the time today answering
your questions, if I may. You have my legal opinion. It is available
to you for any questioning you'd like to put to us, and I thought we
should save the time, if you don't mind for that.

SEN. SPECTER: You're waiving your opening statement?

DR. RABB: If you don't mind.

SEN. SPECTER: Okay.

Let me turn at this point to my distinguished colleague, Senator
Harkin.

SEN. TOM HARKIN (D-IA): Thank you, Mr. Chairman. And again,
thanks for holding this follow up hearing. This is an area that has
captured my imagination, and I think it's one of the most exciting new
realms that we have in science that just holds so much promise. And
that's why I'm just delighted that we got your decision, Dr. Rabb on
this that this research could feed the pace. JI congratulate you, Dr.
Varmus on setting up the subcommittee and do this in a careful
procedural, open way so that the public is aware of what we're doing.

There is, as you know, a lot of concern about this and there are
ethical considerations, I don't downplay those at all. As I've said
before on many occasions that I believe that science, especially in
this area, in stem cell research holds so much promise for alleviating
human suffering and debilitating disease that we have to move ahead
aggressively.

Although, I have said that we have to be careful about the
ethical considerations, I believe that scientists working with
ethicists and lawmakers together, getting good public input, I believe
we can craft that. I believe we have and I believe you have, doctor.
And I think you have a great structure. As I understand it your
guidelines going to be out in a couple of months. That was the first
question that I had, but you answered it. In a couple of months you
have these guidelines ready to go. And I assume then that funding
could then proceed after that, I would hope.

DR. VARMUS: We will. We will submit for public comment, for 30
days public comment.

SEN. HARKIN: I see, so I'm just wondering do you have any idea
right now -- I'm certain requests must be coming in even as we sit
here.

DR. VARMUS: Correct.

SEN. HARKIN: What sort of backlog do you see out there of
requests coming in for this king of funding?
DR. VARMUS: Well, I have only indirect information. There will
be three ways at least to support this research. Some investigators
already have grants and they may be working in this general area, but
want to shift their emphasis to work with human stem cells. There
will be others who may want to supplement existing grants by a small
research application. And others want maybe want to initiate a new
grant.

In addition, we have intramural investigators who maybe
interested. The only way we have to gauge the level of interest at
this point is to ask Doctors Thompson and Gearhart who have made these
cell lines, how many requests they've received? And we know they've
received in the order of 50 to 100 requests from various investigators
for these cells to be worked with. But the investigators have been
informed that at this point NI's funding is not to be used until we
have our procedures in place. And we hope, as I say, that that will
be within the next few months.

SEN. HARKIN: Well, I appreciate that. And again I am grateful
for your opening statement in terms of addressing head on this issue
of encouraging the creation of embryos. I've heard a lot about that.
But as you point out, because of in vitro fertilization we have a lot
of those who are out there, plus the fact that these very potent cells
can continue on. And so, I don't think there's any problem there at
all. And I'm happy that you addressed that issue. I guess the rest
of that question, I just encourage you, Dr. Varmus. I don't think you
need any encouragement in this area, but to really push ahead. I
mean, the more reading I do on this, I'm not a scientist, but the more
reading I just -- this holds so much promise. And it could be in not
too long a time for people suffering from -~(coughing) -- or heart
disease just understanding cancer cell biology, for example, things
like that that we just haven't had that grasp on right now.

I just, again, hope that you'll foresee the pace, again, keeping
in mind the guidelines and the need for public input and open ethical
guidelines. All that taken into account I just hope that you will do
everything you can to get the funding out to the researchers. If we
need to do anything here in the subcommittee, I know Senator Specter
has gotten us a whole lot more money to put into the medical research
this year, so if you need any more of that money we can maybe help
out. I'm just kidding,-- (laughter) -- putting you in a tough spot.
But I hope that we can get that. We're working together on that. I
think the budget from the administration is going to be willfully
inadequate to meet the needs that we have out there. And I'm hopeful
that we can get more. So, any information that you have on the need
for this, in terms of our responsibilities here for funding, I
encourage you to let us know as soon as possible.

DR. VARMUS: I'll do that Senator. Thank you.

SEN. HARKIN: Thank you, Doctor.

SEN. SPECTER: Thank you, Dr. Rabb, for --

DR. RABB: Thank you.

SEN. SPECTER: -~ your (contribution and your time?).

Dr. Varmus, I'll begin with a baseline question. Just what is
the extent of the potential in your professional opinion, from the
stem cells. We've heard very extraordinary comments about potential
on Alzheimer's and Parkinson's and diabetes and cancer and heart
ailments and the whole range of human medical problems. You're the
great expert, director of NIH. Is that potential accurately stated?

DR. VARMUS: Well, no doubt as in all realms of discussions of
this topic, there may be some hyperbole, but much of it is, in my
view, accurate. We have experience with similar work done in
experimental animals. For example, in mice. And we know that it's
possible, we had a long experience, now, nearly 18 years or so,
working with the parallel types of cells. Pluripotent stem cells for
mice. And we know that those cells can be induced to differentiate
into certain kinds of cells. And those cells can be used to replenish
diseased or impaired or missing cells in mouse models of disease, that
the prospects for repairing damaged hearts and treating congestive
heart failure, for example, for returning, missing components of the
blood system, are all very real.

There will be difficulties in treating more complex diseases like
Alzheimer's. And I don't think we should minimize the challenge
there. However, in conditions like diabetes, where we know one
specific type of cell is missing, and that that cell produces a
product which circulates in the body, I think the prospects are great.
As I emphasized last time, there are two major impediments to using
these cells in cell therapy. One is that we have a still very limited
idea of how to take mass cultures of these cells and direct them
efficiently into one cell lineage.

But that information will come as we study the way in which these
cells undergo their changes in program that allows them to select a
cell type to become.

The second problem is one of rejection, histo-compatibility (ph),
the classic problem in transplantation. We know that those problems
may be at different levels of severity with different tissues. We
also know that there are ways to manipulate the cells in culture to
make them seem less foreign to the host.

Furthermore, there are new methodologies that are in development
that could obviate these problems in other ways. For example, by
using our understanding of how cells work and their apparent
plasticity to take one kind of cell from the patient himself or
herself and to remodel that cell to make it able to replace a diseased
or absent tissue.

SEN. HARKIN: Dr. Varmus, you say that diabetes, you single that
out as one, which is closer to solution. I know form time to time we
press you unduly as to a timeframe, maybe, not unduly, but we press
you because for that is a very strong argument with our colleagues to
get additional funding, if you can put it in a timeframe. Could you
give us a ballpark figure as to say diabetes, when this research might
produce the cure?

DR. VARMUS: Well, as you know, Senator, I tend to be more
conservative than some of my colleagues, in making these predictions.
But in the case of Type I diabetes, where we know that the
replenishment of the beta cell of the auto-telangerhans (ph) to the
pancreas does have an important positive effect in some patients
who've been treated, for example, with pancreatic transplantation. In
that setting where we know what we need to do, the major challenge is
to figure out a way to make a pluripotent cell become a beta cell.

SEN. HARKIN: Can you give us a ballpark figure as to how long?

DR. VARMUS: I would say certainly no sooner than five years, but
beyond that I'm guessing, but --

SEN. HARKIN: Let me ask you now about when these guidelines will
be out, when you'll be able to start using funds for research? You
have a whole series of preliminaries, the special guidelines, the
oversight group, additional guidance from the National Bio-ethics
Advisory Board. A comment period, when?

DR. VARMUS: All right.

SEN. HARKIN: I approach this question with the sense of urgency
because, and I don't think it's hyperbolae to say that every day lost,
human lives are lost. So, when?

DR. VARMUS: I share your concerns, Senator. It's been, but I do
think it's important to have an open and fair process because of the
many concerns that are felt. And the feeling that public and Congress
want to have a chance to express their opinions. I'm currently
assembling the group who will work with us to establish the
guidelines.

In the case of the existing cell lines, the cell lines that have
been made, reported, we know all the details about how the tissues
were obtained, I think it's going to be very straightforward. We have
a legal opinion. We have the human embryo, our research panel
guidance. We have regulations with regard to fetal research that are
very useful. I believe that in the course of the next couple of
months, a clear set of guidelines governing work on those cells can be
generated.

I've asked Dr. Shapiro, the chairman of the National Biologic
Advisory Commission if they would attempt to give us some preliminary
information about this specific issue in the course of their larger
evaluation of embryo research in general. I hope we'll have our
guidelines out for public comment within a couple of months. There'll
be a 30-day public comment period. At that point we can begin to allow
our investigators to use federal funds.

SEN. SPECTER: So you say a couple of months to April lst and a
30-day comment period and then that brings us to May lst?

DR. VARMUS: Now I don't want to prejudge exactly how my advisory
committee will do its work and I don't know exactly how they will
segregate the different domains of research because they may find that
some things are very cut and dried and we can move very quickly on;
that other issues, for example, what to do in response to another set
of cell lines -

SEN. SPECTER: Dr. Varmus, we understand you have the problems and
we're pressing on the date so we can figure out the time parameters
and we know how to respond. We don't want to schedule the next hearing
prematurely. My red light is on.

Let me yield to Senator Harkin.

SEN. TOM HARKIN (D-IA): I just want to just follow up on one
thing. It's been my experience, though, getting back to the timeframe
and how things work out and when can we expect results. Twenty-three
years I've served on committees in the House and Senate that deal with
the National Science Foundation and now NIH. It's been my experience
through those years that when you're dealing in basic research, well
and this is sort of basic and applied, there's kind of a fuzzy
boundary here in this one, that sometimes you put a timeframe but you
know sometimes serendipitous things happen in science. But they won't
happen unless you start moving down the pathway. So you can talk
about five years or something, but you never know. I mean maybe in a
year from now or something some scientist working someplace something
happens and you come up with something and that's why I think it's so
important to move ahead aggressively in this because like I say you
never know. I just wanted to make that point that a lot of times in
science those things just happen like that.

DR. VARMUS: Well I appreciate being castigated for my
conservative position. I'm usually thought of as too impetuous so I
appreciate your comments, Senator.

SEN. HARKIN: Thank you, Dr. Varmus.

SEN.SPECTER: We're going to ask you to stay with us Dr. Varmus
and Dr. Rabb. I'd announced at the outset that there are caucuses at
10:00, at least the Republican caucus at 10:00, also with Senator
Harkin on the caucus of the Democrat Senators.

We're going to move now to panel two. We're going to conclude
the hearing by 10:00. And we have not gotten Dr. Rabb into the
definitions, but we do have your very learned opinion. And if you'd
stand by for some dialog and q and a, we'd like to call now Dr. Eric
Meslin and Mr. Richard Doerflinger. Dr. Meslin is the executive
director of the National Bio-ethics Advisory Commission. He received
his Bachelor of Arts degree from York University, Toronto, MA and
Ph.D. in Bio-ethics Philosophy at the Kennedy Institute of Ethics at

Georgetown University. An author of some 35 academic articles and
book chapters and peer review literature, we welcome you here, Dr.
Meslin and look forward to your testimony. As I say the clocks are

set at five minutes to leave maximum time for questions and answers.
DR. ERIC MESLIN: Thank you very much, Senator and good morning,
good morning to you Senator Harkin. I was privileged to appear before
your subcommittee on December 2nd to offer some brief remarks on the
subject of human stem cell research. And at that hearing, Mr.
Chairman, I informed the subcommittee that in his November 20th letter
to President Clinton the NBAC chair, Dr. Harold Shapiro (sp) addressed
only the immediate issue of the purported experiment involving the
fusion of a cow egg and a human cell. And that NBAC would devote a
majority of it's next meeting to the broader issues raised by
President Clinton in his November 14th letter to the commission.
Namely that NBAC undertake a thorough review of the issues associated
with human stem cell research, balancing all ethical and medical
considerations.

Just this past week NBAC met for the 26th time since being
established by President Clinton. The commission devoted the entire
day, January 19th to the topic of human stem cell research, hearing
testimony from a number of leading scientists, bio-ethicists,
theologians, legal scholars and the public. The purpose of this
meeting was to provide NBAC with a deeper understanding of the
ethical, scientific, legal, medical, and policy issues that are raised
by this important area of research.

While the commission did not reach any immediate conclusions at
that meeting, nor where they expecting to, it may be helpful to
describe the range of issues that were discussed, and then to describe
our timetable for completing this report, since I understand how
important it is to you. In our view, an understanding of the legal
status regarding the use of federal funds to conduct human stem cell
research provides an important context for fully understanding the
ethical issues. At our recent meeting, we were very interested to
learn that the office of the General Counsel has rendered an opinion
regarding whether federal funds may be used for research conducted
with human pluripotent stem cells.

We're planning to carefully review this opinion as quickly as
possible, since it provides one of the many pieces of valuable
information we will rely on to fully address the bio-ethical issues
involved in this area of research. In testimony before us, Mr.
Chairman, we heard some compelling arguments in favor permitting
research on human stem cells, based principally on the very promising
results of previous animal studies. Several beneficial uses of these
cells are anticipated, and you've heard those from Dr. Varmus already.

It was also clear that a number of important scientific issues
must be resolved before any actual therapies can be developed or
tested in human beings. These include how to specifically direct stem
cells to differentiate into specific types, such as cardiac muscle or
nerve cells, how to overcome the problem of immune rejection of such
transplanted tissue, and other items.

We also heard some words of caution and objection to all forms of
research involving the human embryo, the human fetus, or the cells or
tissues derived from these sources, respectively. Some of these
concerns related to the potential for complicity in the use of cells
derived from spare or excess embryos, other concerns related to more
fundamental objections to the use of human fetal or embryonic material
irrespective of their source or potential for benefit.

Mr. Chairman, the focus of the NBAC effort is to develop sound
public policy proposals based on appropriate scientific, medical,
ethical and legal considerations. In this respect we hope to use the
experiences from a number of former deliberative bodies.

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01/26/99

And as with all NBAC reports our deliberations, agendas, transcripts
and working papers will be available on our Web site. In reviewing a
working draft outline of the report prepared by my staff, the
commission at its meeting, expressed a strong interest in developing a
report that was focused on a set of answerable and timely questions,
but that would also be able to anticipate certain issues.

The specific issues our report will address are now being
developed for NBAC's consideration, but they will likely focus on some
of the following points. Is there an ethically relevant distinction
between research using human stem cells derived from fetal material
versus research using human stem cells obtained from existing embryos?
How should considerations about the source of human stem cells be
incorporated into the analysis? Is it ethically acceptable to produce
new human embryos as a source of stem cells for research? And
finally, what is the appropriate role of the federal government in
overseeing research of this kind? NBAC would hope that one of the
results of its deliberations on this topic would be to identify the
bio-ethical issues that ought to be considered when supporting such
research or developing guidelines for reviewing research in this area.

Now let me say a word about our timetable. As you know, Mr.
Chairman, NBAC is subject to the Federal Advisory Committee Act, which
you helped co-sponsor. This requires that we conduct all of our
business in public and come to conclusions in public. This means that
any Commission decisions, be they interim conclusions or final
recommendations, can only occur at NBAC meetings. We are committed to

completing this report by June of 1999 or thereabouts, so NBAC and its
staff have mobilized to work as expeditiously as possible. Additional
meetings have now been scheduled. In fact, we will be meeting next
Tuesday and Wednesday, February 2nd and 3rd in Princeton, New Jersey
and monthly thereafter.

I should note, however, that the commission is also preparing for
the possibility of being able to provide to the President conclusions
on certain issues within the next few months. We are keenly aware of
NIH's interest in moving forward with human stem cell research and Dr.
Shapiro has already indicated to Dr. Varmus separately that, if NBAC
reaches any interim conclusions, they will be shared with NIH and
others after they're transmitted to the President.

Naturally, Mr. Chairman, we'll be pleased to provide you and your
staff with an update on our work as it proceeds. I'd be pleased to
answer any questions you may have.

SEN. SPECTER: Thank you very much, Dr. Meslin.

But we now turn to Mr. Richard Doerflinger, associate director
for policy development at the Secretariat for Pro-Life Activities
National Conference of Catholic Bishops.

Welcome, Mr. Doerflinger. We appreciate your coming back and the
floor is yours.

MR. RICHARD DOERFLINGER: Thank you, Mr. Chairman.

I want to begin by noting that a point I made in my December 2nd
testimony on this same matter has received new support from recent
events. Since then, two startling scientific breakthroughs have made
it even more clear that destructive embryo research is unnecessary.
Advances in the use of telomerase to promote regeneration of human
tissues and the new discovery that adult stem cells may be far more
versatile than was once thought offer the promise that embryonic stem
cells may simply be irrelevant to future medical progress.

At the December 2nd hearing, Dr. Varmus noted that while adult
stem cells can be obtained from bone marrow, cord blood and so on,
they're of limited use compared to embryonic cells because they can

not form other kinds of tissue, such as nerve and skin. The most
recent issue of Science suggests that this judgement may well have
been premature. That, in fact, stem cells at a later stage of

development can cross over these boundaries and be adapted to perform
the use of any different kind of cell.

This subcommittee has now held three hearings on one narrow
avenue of research, precisely the avenue that raises the most obvious
moral and legal problems. So far, to the exclusion of all other
alternatives, even when those avenues may be more promising, the use
of adult stem cells, for example, is said to promise the complete
avoidance of the tissue rejection problems that Dr. Varmus has noted,
still need to solved using embryonic cells.

I would urge the subcommittee to expand its vision to explore the
alternatives that will advance medical progress and the well being of
patients without demeaning human dignity.
Turning now to the legal memorandum prepared by the Department of
Health and Human Services. In its effort to find that federal funding
of embryonic stem cell research is consistent with congressional
intent, HHS has overlooked some rather obvious facts and created its
own arbitrary definition of a human embryo, and even more striking, of
a human being that have no basis in biology or federal law.

First, looking at current laws on embryo and live fetal research,
HHS now claims that current law and embryo research does not pose a
barrier to embryonic stem cell research because the law protects only
the embryo, which is an organism. And a stem cell obtained by
destroying embryos is not an organism. HHS even cites me on this
point, but they ignore other parts of my testimony and more
importantly ignore two important aspects of current law.

First, as I noted on December 2nd., there is a factual
uncertainty as to exactly what happens to the stem cells where Dr.
Gearhart of John Hopkins University has cultured from fetal germ cells
after abortions. After being cultured, some of these stem cells have

a tendency to come back together and show signs of developing as an out
early embryo. Whether the formation of early embryos does take place Ur [49
in such a culture, and whether that can be prevented by adapting the

 

research is a scientific question, can't be answered by attorneys.

A stem cell is not an organism, but the possibility must be
explored that groups of stem cells may re-congregate in some of this
research to form and entity that is, however briefly, a living
organism, in which case this research could not be funded.

HHS seeks to avoid this factual inquiry by inventing its own
narrower definition of an embryo, which is not found in federal law.
Such an entity, HHS argues, cannot be an embryo, because even if
implanted in a womb, it could not become a, quote, "Human being."
Oddly enough, the key phrase human being is not defined, but from the
context, it seems to refer to a live born infant. Doctor Varmus'
testimony, I noted, he said a human being is a mature organism. So,
I'm beginning to wonder whether my six year old son qualifies.

Embryology textbooks, however, tell us that in biological terms,
the embryo is a human being. And the current federal law treats the
embryo as a human subject, since 1975, has treated the human embryo as
a human subject to be protected from harmful research, from
implantation onwards, and the current embryo research writer is
intended that protection back before implantation, to the embryo in
the laboratory.

Secondly, HHS seems to misread the embryo research writer itself
rather obviously, by saying that this research can be funded as long
as federal funds are not used for the actual destruction of the
embryo. It can be used for all subsequent work with the stem cells so
derived. But Congress knows how to write a writer that says you
Simply can't use federal funds for that act, it wrote the writer that
way, when it dealt with creation of human embryos. It said federal
funds cannot be used for creation of embryos. Then it said, federal
funds cannot be used for research in which a human embryo or embryos
are destroyed or discarded or subjected to risk of harm. Obviously,
that means if this is an integral part of the research protocol, even
if it's not directly funded by federal funds, the destructive
harvesting of embryos is not supposed to be something that is part of
the research project funded by Congress.

Finally, HHS ignores the possibility that the fetal tissue
transplantation guidelines now in law apply also to the destruction of
embryos in the laboratory. The statute clearly says that it covers
tissue derived from embryos or fetuses and it only allowed the use of
that tissue if the subject was dead before the tissue was obtained and
only if the destruction was not altered in its method or timing by the
needs of the research. Well in all of the research in which embryos
are destroyed here, the destructive process is geared exactly toward
obtaining usable research tissue and toward nothing else. When
embryos are discarded in an IVF clinic, they don't use immuno-surgery
to dissect the inner cell mass from the trophoblast, they simply throw
them away. Everything about the harvesting procedure is altered to
obtain usable tissue and it is the harvesting procedure that is,
itself, the abortion or the destruction.

In conclusion, if Congress wishes to insulate its funding of
medical advances from the destruction of innocent life, there's a very
simple way to do just that. It should devote its funds to stem cell
techniques and other promising avenues of research that in no way
depend upon such destruction and that way our government will truly
serve all the people by showing that it will not promote the
destruction of one human being to serve another or the development of
treatments that millions of Americans would find it morally abhorrent
to use.

Thank you.

SEN. SPECTER: Thank you, Mr. Doerflinger.

Dr. Rabb, the opinion, which you have rendered, focuses on the
proposition that while cells are units of organisms, organisms are
units of life. Except for unicellular life, a cell does not equal an
organism, which is recognized as an animal or plant, not a collection
of uni-cells but a multi-cellular cooperative with the emergent
properties of the whole organism. Now in that context how would you
respond to what Mr. Doerflinger has said, that stem cells may re-

cogenerate into what could be a whole organism. Is that a
possibility?
DR. RABB: I can't respond on the science, Senator Specter. The

question that was asked of me was whether, if one were dealing with an
entity that was not an organism, would one violate the human embryo
ban? And the answer to that is, no, one would not violate the ban, if
one were doing research with an entity that was not an organism.

If the question is, whether one can research with an organism
that would otherwise be subject the human embryo ban, the answer then
again would be, no, one couldn't do such research. But the science was
not in my domain. The law was. And we didn't create our own
definition of an embryo. The definition that we used was the one in
the statute.

And as Senator Harkin point out at the last hearing, at which Dr
Varmus appeared, the statute defines human embryo in terms of an
organism. And that was the question from my office, and the answer we
found through science was that these stem cells, not being organisms,
are not subject to the ban.

SEN. SPECTER: So, when Mr. Doerflinger says that the destructive
harvesting of embryos is indispensable, would your response be that
stem cells can be obtained for this kind of research without the
destructive harvesting of embryos?

DR. RABB: That's a science question again, Senator Specter.

What I can say is that however derived, not using federal funds, once
derived, stem cells are not organisms and therefore are not subject to
the ban.

SEN. SPECTER: Well, since it's a science question, Dr. Varmus
you enter center stage here. Is it possible to acquire these stem
cells for the research without having the destructive harvesting of
embryos?

DR. VARMUS: At this point, Senator, no. The cells derived from
embryos do require the destruction of the embryo. Obviously, in
derivation from fetal tissue, the tissue comes from a fetus, which is
already died. Let me make a point about the issue that Mr.

Doerflinger raised with respect to whether pluripotent stem cells soa 1
culture can become organisms. It's true that sometimes these cells

can aggregate and may appear like one of the early phases in the
development of a normal embryo. But to my mind, nothing would be less
ethical than to attempt to ascertain whether or not this was indeed

the precursor to an organism, a viable embryo. That, that would

require returning that mass of cells to a uterus to ask whether it has

the potential development to develop into a fetus and then a newborn
and the prospect for developing a severely impaired individual would
be enormous and to my mind reprehensible means of doing research.

SEN. SPECTER: Dr. Rabb, you made a comment that except for the
unicellular life a cell does not equal an organism. Would you explain
what you mean by the exception of the unicellular life?

DR. RABB: I'm going to try. This gets to be science again. An
organism is as it's been explained to the science is an individual
instituted to carryout all of life functions. There are some
unicellular animals. For those animals, the full potential of their
lives inheres in a single cell. For human beings it is the complex
interrelationship of all of the human systems that make up the
organism. And --

SEN. SPECTER: Dr. Varmus, one final question for you. When Mr.
Doerflinger makes the point that we have ignored other new
developments, which might lead us to the same avenues as stem cells,
are you pursuing the kinds of lines of inquiry that Mr. Doerflinger
suggests --

DR. VARMUS: Absolutely, Senator. I'm glad you brought that up.
Many of us were pleasantly surprised by the report that appeared in
Science this week, a copy of which I have given your staff, that shows
that stem cells taken from the mouse brain, grown in culture, can be
returned to a mouse and produce blood cells. This indicates a level
plasticity that was unexpected and, of course, a very promising area
of research.

But I must emphasize, this is one report carried out in one way
with one strain of mice. But if this approach will be applicable in
other strains of mice, other animals with other types of cells,
whether we can identify what is responsible for reprogramming the
cell, all matters of conjecture. My view is, yes, we should be
pursuing this and many other lines of investigation with relation to
many kinds of stem cells. But to say that we should put our eggs in
one basket and not in all the available baskets would be a serious
mistake.

SEN. SPECTER: So, you're saying that NIH has eggs in those other
baskets?

DR. VARMUS: Absolutely.

SEN. SPECTER: Senator Harkin.

SEN. HARKIN: Thank you, Mr. Chairman.

Mr. Doerflinger, I was just reading an article that you had
written here for the National Right to Life News, which I found
interesting. Let me just ask you, in vitro fertilization is not
illegal, is it?

MR. DOERFLINGER: No.

SEN. HARKIN: Is it immoral?

MR. DOERFLINGER: In Catholic teaching, there are immoral
problems with it, yes.

There's a good bit of research however involving in vitro
fertilized embryos that is illegal in various states.

SEN. HARKIN: I don't think the church has taken the position
that an infertile couple can engage in, in vitro fertilization. Maybe
I'm wrong --

MR. DOERFLINGER: The catholic teaching does not accept in vitro
fertilization as a solution for infertile couples. It urges them to
pursue fertility treatments that will help their sexual union to be
pro-creative, if that's what they want rather than to substitute a
laboratory procedure for that.

SEN. HARKIN: Well, I'll have to check, but I didn't think that
they'd taken an absolute position against in vitro fertilization.

So, you have in vitro fertilization --

MR. DOERFLINGER: I'm pretty close to that situation, Senator.

SEN. HARKIN: Huh?

MR. DOERFLINGER: Working for the National Conference of Catholic
Bishops, I'm fairly close to that situation.

SEN. HARKIN: Well, I'm sure you would be. I would hope so.

(Laughter. )
But, I still, I didn't think that they had taken a position that
said that you can't use in vitro fertilization, but maybe I'm wrong.
I don't know.

MR. DOERFLINGER: I'll be glad to send you the documents on it.

SEN. HARKIN: Am I wrong?

MR. DOERFLINGER: Uh --

SEN. HARKIN: Have they taken an absolute position on it?

MR. DOERFLINGER: I never like to say that up front to a Senator,

but I think so Senator. I'11 send you the documents on it.
SEN. HARKIN: Well, I don't know, I mean you're the authority on
that, I don't know. And -- send it to me.

MR. DOERFLINGER: Among the concerns that have been raised beyond
the Catholic Church about the procedure is the prospect for abuses to
the embryos that come out of the procedure, the culling of high
quality embryos, the discarding of embryos --

SEN. HARKIN: Well, that's my point --

MR. DOERFLINGER: The selective reductions that are proposed when
too many of the embryos implant and these are all part of the problem.
SEN. HARKIN: So, we've got in vitro fertilization, at least it's
not illegal, we have a lot of it going on and obviously, there are a

lot of leftovers that are frozen. What happens to them?

MR. DOERFLINGER: Some are frozen indefinitely. Some are
ultimately used for later attempts at having a child. And some are
experimented on and some are thrown away, some are destroyed.

SEN. HARKIN: Well if, in fact, this is not illegal and they are,
in fact, some are destroyed, why not use them to get the pluripotent
cells that we need to do the kind of research that may help us in the
future alleviate human suffering? I don't understand why we can't do
that.

DR. DOERFLINGER: Well, Senator, I think that's a question that we
explored a little bit at the last hearing. There are lots of things
that go on in the private sector that are going to go on anyway that
Congress has decided not to add its encouragement to by giving federal
funds, abortion being an excellent example. It's not only legal, I
mean it's more legal than destructive embryo research, which is a
felony in several states. It's defined as a constitutional right, but
Congress has decided we're not going to use federal funds to give our
endorsement to it.

I think you could just as well say if you're walking down the
street and you find a bunch of big tough guys beating up an old man, a
question arises whether, before they're done with him, you could take
his liver because you need it, and thus killing him a little earlier.
I don't think whatever somebody else is doing out there in the private
sector that they're going to do anyway has much influence in what
Congress has to decide in its policy decision on what to promote. See
in this case, this is not a case analogous to the fetal tissue
situation where the abortion's been done. And as Henry Waxman said in
1993 on the House floor, the only question left is whether to throw
away the tissue that's left after the fetus is dead, or make use of
it. Here is a case where the researcher's harvesting procedure does
the destruction itself. That's a very different moral proposition.

SEN. HARKIN: But it's going to take place, as I said.

DR. DOERFLINGER: It's going to take place anyway. Senator you
and every other Senator in the Senate voted in 1997 to reject federal
funding of euthanasia, even though all of those people are going to
die pretty soon anyway.

But it makes a difference whether they're going to die of some other
cause or whether the government's going to help kill them.

SEN. HARKIN: Well, as you said, here, in this article, you said
that, such experiments that we're talking about here create new human
life. I thought we got through that. Organisms, these are not
organisms. They can not develop into full human life. That every
scientist I've ever asked that question to says that and yet, you seem
to want to bring it back across that boundary line again and I just
don't understand that.

MR. DOERFLINGER: Well, I think what I was saying, Senator, was
there is a factual uncertainty about one of these experiments, Dr.
Gearhart's, which is, you know, it can be settled in a factual way.
It's an uncertainty he, himself, has and the question, the answer that
Dr. Varmus has given is intriguing because if we really don't know and
there's no ethical way to find out, that might answer the question in
the direction of saying, we can't fund it, then.

But my broader question was simply that HHS gave an answer to
that question, which is probably right as far as it goes, but it's the
wrong question because the embryo research writer was not intended
only to say that you can't use federal funds for the destructive act
itself. It was designed to prevent federal funding of an entire
research project in which these are destroyed, even if they're
destroyed with private funds.

SEN. HARKIN: Well, I disagree with that interpretation. I
adamantly disagree. That's maybe your interpretation. I don't
believe Congress -- you have to show me report language or anything
else that indicates that we intended it to be that broad and that
encompassing. I don't believe that.

MR. DOERFLINGER: We have two clauses there right next to each
other. The first one says, you can't use federal funds for creation
of embryos. If your interpretation is right, I can't think of a
blessed reason why they didn't just say, federal funds can't be used
for destroying embryos. They didn't say that. Instead, they said,
they used an entirely different phrase right next to the first one
saying, can't be used for research in which embryos are destroyed or
discarded. Now, that can't mean the same thing as the first clause
cause it's very deliberately written more broadly.

SEN. HARKIN: I have to think. You lost me on that one. I have
to --

MR. DOERFLINGER: If you want to rewrite the writer, then we can
have a debate about that.

SEN. HARKIN: Here it is. This is it right here.

None of the funds made available by PL 10491 may be used for one,
the creation of a human embryo or embryos for research purposes.

Two; research in which a human embryo or embryos are destroyed,
discarded or knowingly subjected to risk of injury or death greater
than that allowed for research on fetuses in utero under 45 CFR, et
cetera.

For the purposes of this section, I will read one more time.

The phrase human embryo or embryos shall include any organism not
protected as a human subject under 45 CFR 46 as of enactment of this
act, et cetera, et cetera, et cetera.

Now again, I think that's the essence of the finding at HHS. It
is clear that these are not organisms --

MR. DOERFLINGER: -- That the stem cells are not organisms.
SEN. HARKIN: -- and research cannot be covered by that law, Mr.
Doerflinger.

If you want to change the law --

MR. DOERFLINGER: I'm not talking about the stem cell being an
embryo, I'm talking about the stem cell that you have to kill to get
the stem cells.

SEN. HARKIN: Wait a minute.

MR. DOERFLINGER: As an integral part of that is critical.

(Cross talk)

SEN. HARKIN: -- to get the stem cell. I don't understand what you
just said.
You said, the stem cell you have to kill to get the stem cell.

MR. DOERFLINGER: No, I said the embryo you have to kill to get
the stem cells.

The stem cells are simply the inner cell mass of an embryo. The
way the stem cells is obtained is by doing microsurgery on an embryo
and sucking out the inner cell mass to provide stem cells for culture.
What I'm saying is the destruction of that initial embryo in two of
the three experiments we're talking about because Dr. Gearhart's
experiment is using fetal tissue. But in Dr. West and Dr. Thompson's
experiments, integral part of the research protocol is you must
arrange for these embryos to be destroyed by the harvesting of these
cells. It is not after the embryo is dead. It is what kills the
embryo.

It seems to me that that's what Congress was intending to
prevent.

SEN. SPECTER: Senator Harkin do you have another question?

SEN. HARKIN: No thank you very much, Mr. Chairman.

SEN. SPECTER: Thank you very much.

Senator Hollings.

SEN. HOLLINGS: Would you care to comment on -- (off mike.) -- ?

DR.VARMUS: JI think the point is that the law for our minds reads
quite clearly. And it's not our job to try to discern intent when
intent is not described by report language or other means of
discernment. So, our view is that there is a very clear distinction
to be made between research in which stem cells have been developed in
one laboratory by one procedure are then used by other investigators
to support other kinds of research. That is not research in which an
embryo, an organism is subjected to risk from those that are dictated
by other statutes.

SEN. HOLLINGS: Thank you, Mr. Varmus.

SEN. SPECTER: Thank you, Senator Hollings.

We are now slightly past 10:00, so we're going to have to
adjourn. We thank you very much for coming again today. And this is
obviously going to be an ongoing matter of great public interests as
we pursue the steps, which are set up. And we appreciate your
participation Mr. Doerflinger to give us your analysis. And you have
immunity here when you criticize Senators. You can say Senators are
wrong. That comes under --Senator Hollings is accurate about that,
but you have a privilege to make those statements. We're here to have
an exchange and we appreciate your incisiveness, and your study, and
your knowledge in the field. And we thank you Dr. Varmus, Dr. Rabb,
and Dr. Meslin and stay tuned. Thank you all very much.

End of hearing.

END
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Report is Completed