[Senate Hearing 107-444]
[From the U.S. Government Publishing Office]
S. Hrg. 107-444
CLONING, 2001
=======================================================================
HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
__________
SPECIAL HEARING
DECEMBER 4, 2001--WASHINGTON, DC
__________
Printed for the use of the Committee on Appropriations
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COMMITTEE ON APPROPRIATIONS
ROBERT C. BYRD, West Virginia, Chairman
DANIEL K. INOUYE, Hawaii TED STEVENS, Alaska
ERNEST F. HOLLINGS, South Carolina THAD COCHRAN, Mississippi
PATRICK J. LEAHY, Vermont ARLEN SPECTER, Pennsylvania
TOM HARKIN, Iowa PETE V. DOMENICI, New Mexico
BARBARA A. MIKULSKI, Maryland CHRISTOPHER S. BOND, Missouri
HARRY REID, Nevada MITCH McCONNELL, Kentucky
HERB KOHL, Wisconsin CONRAD BURNS, Montana
PATTY MURRAY, Washington RICHARD C. SHELBY, Alabama
BYRON L. DORGAN, North Dakota JUDD GREGG, New Hampshire
DIANNE FEINSTEIN, California ROBERT F. BENNETT, Utah
RICHARD J. DURBIN, Illinois BEN NIGHTHORSE CAMPBELL, Colorado
TIM JOHNSON, South Dakota LARRY CRAIG, Idaho
MARY L. LANDRIEU, Louisiana KAY BAILEY HUTCHISON, Texas
JACK REED, Rhode Island MIKE DeWINE, Ohio
Terrence E. Sauvain, Staff Director
Charles Kieffer, Deputy Staff Director
Steven J. Cortese, Minority Staff Director
Lisa Sutherland, Minority Deputy Staff Director
------
Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
TOM HARKIN, Iowa, Chairman
ERNEST F. HOLLINGS, South Carolina ARLEN SPECTER, Pennsylvania
DANIEL K. INOUYE, Hawaii THAD COCHRAN, Mississippi
HARRY REID, Nevada JUDD GREGG, New Hampshire
HERB KOHL, Wisconsin LARRY CRAIG, Idaho
PATTY MURRAY, Washington KAY BAILEY HUTCHISON, Texas
MARY L. LANDRIEU, Louisiana TED STEVENS, Alaska
ROBERT C. BYRD, West Virginia MIKE DeWINE, Ohio
Professional Staff
Ellen Murray
Jim Sourwine
Mark Laisch
Adrienne Hallett
Erik Fatemi
Adam Gluck
Bettilou Taylor (Minority)
Mary Dietrich (Minority)
Sudip Shrikant Parikh (Minority)
Administrative Support
Carole Geagley
Emma Ashburn (Minority)
C O N T E N T S
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Page
Opening statement of Senator Tom Harkin.......................... 1
Opening statement of Senator Arlen Specter....................... 2
Opening statement of Senator Mike DeWine......................... 4
Statement of Hon. Sam Brownback, U.S. Senator from Kansas........ 4
Statement of Dr. Michael D. West, president and CEO, Advanced
Cell Technology, Worcester, MA................................. 14
Prepared statement........................................... 16
Statement of Dr. Ronald M. Green, professor, Dartmouth College... 20
Prepared statement........................................... 21
Statement of Dr. Bert Vogelstein, professor of Oncology and
Pathology, Johns Hopkins University, Baltimore, MD............. 23
Prepared statement........................................... 25
Statement of Phyllis E. Greenberger, president and CEO, the
Society for Women's Health Research, Washington, DC............ 26
Prepared statement........................................... 28
CLONING, 2001
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TUESDAY, DECEMBER 4, 2001
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 9 a.m., in room SD-192, Dirksen
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
Present: Senators Harkin, Specter, and DeWine.
OPENING STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. This hearing of the Senate Labor, Health
and Human Services, and Education Appropriations Subcommittee
will now come to order. Three years ago, Dr. Michael West of
Advanced Cell Technology testified before this committee about
a new plan to transplant a patient's DNA into a human egg, grow
some stem cells, and then use those cells to cure devastating
diseases. It was a plan that brought hope to millions of
Americans suffering from Alzheimer's, Parkinson's, spinal cord
injuries, diabetes, and many other diseases and debilitating
conditions. Late last month Dr. West announced that he had
taken the first step toward reaching that goal. Dr. West's
announcement received a great deal of media attention, but it
has also started an avalanche of disinformation about what this
advance means and whether or not it will lead to human cloning.
I think it's time to spend more time on the facts and less on
the fiction. That's why Senator Specter and I decided to invite
Dr. West to join us once again today.
One thing has become very clear in this debate: as long as
the opponents of stem cell research can wave the flag of human
cloning, science will be inhibited. The proposition of human
cloning worries most Americans, as it should. Some choose to
feed these worries. That's why I think it's important forever
to separate the issue of human cloning from the science of stem
cell research.
Soon I will be introducing legislation that will ban human
cloning, and impose strict criminal and civil penalties on any
misguided person who would conduct this type of procedure. This
legislation would draw what I call an ``iron curtain'' between
responsible research and misguided attempts to pursue human
cloning. At the same time that this ``iron curtain'' shields us
from a reckless few, it protects responsible scientists, allows
them to continue their search for cures to many devastating
diseases, and I think it is very important that we make that
distinction. The chart that I have here illustrates my point.
The research we're discussing today involves taking the DNA out
of a donated egg and replacing it with the DNA from someone who
may have a disease like Alzheimer's or Parkinson's. That's
called somatic cell nuclear transfer. Now my bill prohibits
this process from ever leading to a human clone. But it does
allow the creation of stem cells that could result in a cure;
in other words, once you get the somatic cell nuclear transfer,
you can go two ways: you can go to implantation in a woman's
womb to try to get a cloned human, or you go in the other
direction to get the stem cells that can go to cure someone who
has an illness. What my proposed legislation would do would be
to ban that one avenue, and to impose very strict criminal and
civil penalties on anyone who would engage in that, thus
leaving open the avenue that would go from somatic cell nuclear
transfer down to stem cells and to possible cures.
This technology and science has enormous potential to ease
human suffering, and I believe it would be a very serious
mistake to ban it. My legislation would protect our values by
banning human cloning, but protect our health by fostering
research into stem cells.
We're very fortunate to have a distinguished panel of
witnesses to testify about these issues this morning. Before we
hear from them, I would turn now to my distinguished ranking
member, Senator Specter, to make his opening remarks.
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Well, thank you very much, Mr. Chairman,
and thank you for promptly scheduling this hearing within just
10 days of the widely publicized disclosures regarding the
cloning issue, which reached the covers of the national
magazines. I think it is very unfortunate that the name
``cloning'' has been attached to what is called ``therapeutic
cloning,'' because it confuses the issue with reproductive
cloning, and the appropriate scientific name, as you have
already noted, Mr. Chairman, is somatic cell nuclear transfer.
And there is no doubt about the abhorrence of reproductive
cloning to create another human being. But simply stated, that
is not what is involved here. What we have, essentially, is a
technique which involves the taking of genetic material out of
an unfertilized egg and inserting in its place the DNA of an
adult cell, for example if somebody is suffering from
Parkinson's or Alzheimer's or amyotrophic lateral sclerosis, so
that when the stem cells are derived and injected into that
individual, there is not a rejection. We have had some very
heated debate on the floor of the U.S. Senate with all of the
evils and all of the dangers of human cloning, which we all
agree to. But I do believe it is plain at this juncture that we
can have legislation which will ban human reproductive cloning
without prohibiting so-called ``therapeutic cloning.'' But I
believe that it is indispensable that the scientific community
come forward and take an aggressive role in educating the
American people as to just what is involved here. The House of
Representatives has passed legislation which prohibits somatic
cell nuclear transfers, so-called ``therapeutic cloning,'' and
it is entirely possible that the Senate could take similar
action. And we had the matter come to the floor of the Senate
with our appropriations bill for the Department of Health and
Human Services where this subcommittee and the full committee
inserted language which would codify the decision of President
Bush to permit Federal funding on existing stem cell lines.
Now there is little doubt that President Bush does not
intend to permit Federal funding on stem cell lines beyond the
approximately 70 which he identified as of August 9. But the
subcommittee wanted to codify that, and the full committee
agreed, but concerns were raised on the Senate floor about that
provision on the grounds that another president might permit
further funding. Then amendments were offered which would raise
a whole range of prohibitions against reproductive cloning and
therapeutic cloning, and in order to avoid a lengthy debate we
deferred the matter until February or March when the Senate
majority leader has agreed to take this issue up as a free-
standing bill. Then the publicity occurred 10 days ago when the
matter was back on the Senate floor yesterday in a complex
procedural issue where an effort was made to bring the matter
back up, notwithstanding our agreement to defer it until
February or March, and it came up on a so-called ``cloture
vote'' and was defeated. That is interpreted in this morning's
news media as saying that the Senate has rejected the effort on
banning somatic cell nuclear transfers or therapeutic cloning.
Well, that's not exactly right, but I don't think it's going to
come back up this session.
This hearing has been called so that the scientific
community can come forward. My own view is that the limiting of
the Federal funding on stem cell research to the approximately
70 lines in existence as of August 9 is tying the hands of
scientists. There hasn't been a groundswell on that issue
because there has been insufficient time to find that those
lines will not support all the research which is necessary. But
prior to the President's announcement, we had some 64 senators
who had signed on urging Federal funding on stem cell research,
and another dozen had orally committed to me that they would
support Federal funding, but didn't want to put it in writing.
So what we have are a group of issues where there is
enormous potential for curing Parkinson's and Alzheimer's and
heart disease and cancer and to have these matters inhibited on
ideological grounds is, in my view, just unthinkable in the
21st century. There are people who feel very passionately on
the other side, and in accordance with the way our democracy
works, let's shed light on it. Let's bring it all out into the
open. But to do that, the scientific community is going to have
to be activated. Too often the scientific community is inert.
And Senator Harkin and I have taken the lead in adding some $11
billion to the $12 billion in NIH funding, including our
current appropriations bill, thereby providing the funding
resource for enormous advances to cure many, many maladies.
So that's the challenge we have. So I hope the scientific
community--I know quite a few will watch this on C-Span--
understands that the time has come to move forward. Thank you
very much, Mr. Chairman.
Senator Harkin. Thank you, Senator Specter. Senator DeWine.
OPENING STATEMENT OF SENATOR MIKE De WINE
Senator DeWine. Mr. Chairman, I just thank you for this
hearing. I'm a co-sponsor of Senator Brownback's bill. I'm
looking forward to hearing his testimony and also hearing the
other witnesses as well. Thank you.
Senator Harkin. Thank you, Senator DeWine. I'll leave the
record open for any other statements that any other members of
the subcommittee might have. Now we'll turn to our first
witness, our colleague Senator Brownback, who was elected to
the Senate in 1996 and serves on the Commerce, Science and
Transportation Committee, the Judiciary Committee, and the
Foreign Relations Committee. He received his law degree from
the University of Kansas and his BA from Kansas State
University. Senator Brownback has testified before this
subcommittee two times on the issue of stem cell research, and
it is a pleasure to welcome him back again to discuss this
important issue. Senator Brownback, welcome back.
STATEMENT OF HON. SAM BROWNBACK, U.S. SENATOR FROM
KANSAS
Senator Brownback. Thank you very much, Mr. Chairman,
members of the committee and thank you for allowing me the
opportunity to be here to testify in front of you today. My
testimony will be more in the form of questions than in
comments, as I really think that's the stage that we're at with
the issue of human cloning, and that's why I've advocated on
the floor a moratorium at this point in time before we go
forward with further human cloning, under whoever's definition
you want to put it, of human cloning, but that we just call a
timeout now, while we really contemplate some deep questions.
I've supported and continue to support you and Senator
Specter's efforts to increase funding at NIH for incredible
breakthroughs that I think are potentially there as well in
other areas, and in adult stem cell work, which I'm a strong
advocate of us funding. And I continue to support that funding
increases that you put forward at NIH and I think that's a
wonderful place for us to invest. So we can find cures, so we
can give hope. So we can give a better life to people that
certainly deserve it. But at this point in time I have a lot of
questions about human cloning and I think that's really where
the public is, and that that's why the public in such an
overwhelming fashion is opposed to human cloning. In any poll
that you see it gets nearly 90 percent opposition to human
cloning. And I want to pose some of those questions to you if I
could this morning.
The issue of human cloning is an issue of vast historical
significance, and one that should give us all considerable
pause. It is, as I have stated before, a debate with a moral
status of the young human. Succinctly put, is the cloned human
a ``who'' or a ``what?'' A person or a thing? Does a cloned
human embryo have any moral significance? Is there a difference
between a human embryo created by man and one created by God?
These are historical questions that the world is grappling with
right now, as we hold hearings here, hearings are being held in
the European Union, in capitals throughout the world some 28
countries have already wrestled with and passed laws to some
degree or another dealing with the issue of human cloning. Yet
it is occurring in our country, and I really, Mr. Chairman,
with all deference to my colleagues, think that this is a
moment in history, the history of humanity, that we should
pause. Just pause for a period of time and really hold a series
of hearings over a period of months, while we hold up and say,
now wait a minute, before we unleash this issue, and this
question, let's pause, and let's really think this through and
debate. Is this a person or not? Does this have any moral
significance or not? And let's bring in a broad cross-section
of people over a lengthy period of months, and then let's take
this issue forward, rather than saying ``We will let private
companies decide this issue in the absence of any speaking of
this by the congress and the president of the United States,''
which is currently the situation of what's taking place.
That's why I really think that this issue deserves
considerable debate, and a moratorium at this period of time,
for a period of 6 months, while we really sort through these
historic questions about humanity.
Let me read to you some comments from other people that I
want to share the broad-based nature of the concern over the
issue of human cloning at this point in time. Because there's
an interesting coalition of groups that are forming opposed to
all human cloning, by all definitions, all human cloning. In
fact, pro-choice feminist Judy Norsega, and biologist Stuart
Norman recently commented in a Boston Globe column the
following: Because embryo cloning will compromise women's
health, turn their eggs and wombs into commodities, compromise
the reproductive autonomy, and with virtual certainty lead to
the production of experimental human beings, we are convinced
that the line must be drawn here.
Now despite some similarities, this debate is not about
abortion, and I don't think it should be confused with that
debate. And perhaps this is why we have such a broad coalition
forming of groups who are strongly opposed to abortion, groups
also that are strongly supportive of abortion,
environmentalists and others. The reason for the broad range of
interests is that there is truly something about this issue
that should concern us all, and should cause us to pause.
I'd like to read another statement, this from an
environmentalist group. Dr. Brent Blackwelder, president of
Friends of the Earth, stated at a recent news conference this:
``Environmentalists embrace an ethic of respect for nature
and strive to demonstrate the interdependence of humans and our
natural world. Proponents of cloning and inheritable
modification, on the other hand, extol the virtues of `remaking
Eden,' of improving what nature has given us. For example:
designer babies, or the cloning of pets that don't cause
allergies, will lead us down a slippery slope toward the
redesign of the rest of life. Indeed, if society allows the
cloning of human beings today, inheritable genetic manipulation
of humans and all other species cannot be far behind.''
Now Mr. Chairman, I don't necessarily agree with what both
of those individuals are saying. But what I want to demonstrate
for you is the depth of conviction that some people have of the
real historical questions that we're entering into right now,
and that we're not even speaking on it. The Senate has not
issued its rules that it is saying on this. There are no
regulatory guidelines. These things are taking place basically
at the review of ethical boards put forward by private
companies. At a monumental time. At a monumental time.
Therefore, Mr. Chairman, I would submit that the technology
is now moving faster than expected, and our ability to consider
a full and permanent ban on human cloning is moving slower than
it should, and that it is time for us to pause and contemplate.
I urge my colleagues, and in particular the Majority Leader, to
call up H.R. 2505, that's the House-passed bill on a permanent
ban on human cloning, or at a minimum--at a minimum--a 6-month
moratorium so that we can restore the status quo in our
country, until such time as the Senate can debate and really
hear the issue.
The President has asked for us to pass the 2505 bill that
the House has passed by a bi-partisan majority, a hundred vote
margin passed that House bill overall. And I really think
that--I do know how this debate--I do not know how this debate
will be resolved, Mr. Chairman, but I do know that history is
watching what we do today, and it will record our actions for
the benefit of our ancestors. And I hope it's a history that we
can be proud of at this point in time.
Mr. Chairman, I don't want to disparage anybody's work in
the research community that they've done. I think all operate
from a laudable set of objectives. But this is one that
shouldn't be decided by private companies. The public bodies
should speak, and should speak clearly on this issue, and we
should have a moratorium at the present time, while we consider
the full ramifications of what we're doing. Thank you, Mr.
Chairman.
Senator Harkin. Thank you, Senator Brownback, for, as
always, a very thoughtful and lucid presentation.
You were asking for a 6 month moratorium, is that correct?
Senator Brownback. At this point in time, what I was
bringing up on the floor yesterday was a moratorium for a
period of 6 months, while we could fully contemplate, consider
the issue, before really the technology gets out way in front
of the contemplation.
Senator Harkin. I just want to be clear. Since this is a
private company that's doing this, I'm not certain if they're
using any Federal monies at all--I don't know that. The answer
to that question I'll find out soon, I guess. But how do you
stop a private company?
Senator Brownback. We put a moratorium on human cloning of
all types for a period of 6 months.
Senator Harkin. But how is it enforced against a private
company?
Senator Brownback. You could do the 2505 bill and sunset it
in 6 months.
Senator Harkin. No, but I'm saying----
Senator Brownback. And that is a total ban.
Senator Harkin. I mean, do you have criminal penalties or
civil penalties in place?
Senator Brownback. Criminal and civil penalties that would
be in place for 6 months--period of 6 months and you would
sunset it after that period of time so that they would have to
act.
Senator Harkin. What happened to my chart? You've taken an
egg and removed the DNA, and you've taken the DNA out from this
individual that may have Alzheimer's and you've placed this DNA
in this egg. What I'm saying is, you could put an iron curtain
right here [motioning to chart], and say you can't go that
path, but you could go this path. You still want to put a
moratorium on that?
Senator Brownback. If I could answer your question with the
recommendations of the National Bioethics Advisory Commission--
this is 1997--they stated this about the creation of that
middle are, the somatic cell nuclear transfer. ``The Commission
began its discussions fully recognizing that any efforts in
humans to transfer a somatic cell nucleus into an enucleated
egg involves the creation of an embryo, with the apparent
potential to be implanted in utero and developed to term.'' In
other words, that creation of the entity right there is a
creation of the embryo by definition of the--President
Clinton's National Bioethics Board, with the potential of
implantation. I don't see how you stop the implantation from
then taking place.
Senator Harkin. Well, you pass a law that says if you do
this, this has criminal and civil penalties attached to it.
Senator Brownback. But what effect are--let's say you do
implant at that point in time. Are you going to require that
she abort the child in the law? I wouldn't anticipate we would
do that. There might be some penalty that you put on a person,
but you will have a cloned human born at that point in time.
Senator Harkin. All right, I'll ask you the question. You
say that you want to put the ban right here [motioning to
chart]----
Senator Brownback. From the creation of the somatic cell--
--
Senator Harkin. Stop it right here [motioning to chart]----
Senator Brownback. That's where an embryo is created by the
definition of the National Bioethics Board.
Senator Harkin. Let's say that someone went ahead and did
it, and implanted it, then what would you do? Would you say
that that woman would have to abort it or not?
Senator Brownback. No.
Senator Harkin. What would you do?
Senator Brownback. I think you're going to--you're going to
see the civil penalties put in place, but the child is going to
be born.
Senator Harkin. Well then, the penalties that my bill would
put in place would be the same as yours if this happens. Right?
If----
Senator Brownback. I don't know what penalties you'd put--
what would there be penalties----
Senator Harkin. Well, let's say I have civil and criminal
penalties, you would put these starting here [motioning to
chart.] It would cover both of these.
Senator Brownback. From the creation of the embryo, yes.
Senator Harkin. What my legislation would do is say, okay,
you would stop it here, you put the criminal and civil
penalties here. Your question to me was, well what if someone
went ahead and did this, what are you going to do? I mean,
you're not going to abort it or anything but I asked you the
same question. What if you draw the iron curtain here
[motioning to chart] and someone goes ahead in a private
company, does this, then implants it, you face the same problem
with your legislation.
Senator Brownback. You have that problem, but I also--as I
posed at the outset the question of is there any moral
significance at all to the creation of an embryo? Is there any?
And what I'm submitting to you at this point in time is that we
should err on the side of caution and say there is some moral
significance here, and that we shouldn't be allowing that to
take place. I think you try to do the best you can to keep that
from occurring.
Senator Harkin. I just want to be clear on that, where
you'd draw it here [motioning to chart,] some of us would draw
it here and permit this. Now----
Senator Brownback. The House drew it there as well.
Senator Harkin. Pardon?
Senator Brownback. The House, in their passed bill, drew it
there, and that is what the President is seeking as well.
Senator Harkin. You mentioned in your comments, Sam, that
these ethical guidelines were put forward by private companies.
In fact you pointed out that there was a national bioethics
commission set up--at NIH it has just gone out of commission in
October of this year, by the way, it sunsetted. They came up
with a number of recommendations and ethical guidelines for
stem cell research. And quite frankly, if you match their
guidelines with the guidelines proposed by President Bush on
August 9 of this year, they are exactly the same, except for
one thing, one thing. I've got the list, I compared them side
by side, they're exactly the same but for the fact that the
President said you could only utilize stem cell lines that were
derived prior to 9 p.m. on August 9. The bioethics commission
did not draw that kind of arbitrary line. But the other thing--
you know, you can't buy them, there cannot be any monetary
consideration, they cannot be used for reproductive cloning--
all those were in that bioethics commission. So this was not a
private company. This was a separate bioethics commission you
just quoted from.
Senator Brownback. Yes, but--we know about the issue of
stem cells, but I think that issue's been resolved pretty much
by the President's order. What we're talking about here is the
creation of a human clone, and I consider this a different set
of issues that you're talking about on creating an actual--into
which--as I recall in front of this entity before, this body
before--most of the Members were advocating then we shouldn't
be creating embryos for research purposes. I think the Members
here have stated that to me previously. We're talking about,
these are leftover embryos at in vitro fertilization clinics,
going to be thrown away, so why not? Which, I have some
questions about that, but that's not the stage we're at now.
Now we're talking about the actual creation of embryos for
research purposes, which Members of this body had talked
previously we should not be doing that, and we should not be
going there.
Senator Harkin. That will be coming up here later about the
definition really of an embryo and if something reaches just
the blastocyst stage, it is--I'm not a scientist, but from what
I have been told by scientists is that, at that stage of the
blastocyst, where you have the requisite number of cells that
you could extract for stem cell purposes, that at that stage
the embryo really cannot be implanted in the womb. So it's
still something prior to, or pre-embryonic at that point. It
becomes embryonic at some point after that. Now I will ask the
scientists to further elaborate on that. But you are saying
that as soon as you take DNA of any nature and put it in an
egg, you have an embryo. That's what you're saying.
Senator Brownback. I'm quoting from the National Bioethics
Commission, that they're saying that's the creation of an
embryo at that point in time. And the DNA structure of that
embryo is the same DNA structure that, if you let it fully grow
through to term, to full physical status, its DNA structure
will not be any different. It will be--that will be its DNA.
Senator Harkin. Let me ask you this question, Senator. Are
you in favor or opposed to in vitro fertilization?
Senator Brownback. I have no opposition to in vitro
fertilization. And the issue here is about the creation of
clones. I've had a number of friends and family members--not
family members--friends who've gone through that procedure and
they have children--beautiful children.
Senator Harkin. So in vitro fertilization is fine?
Senator Brownback. It is fine by me.
Senator Harkin. But as you know, when you have in vitro
fertilization you have leftover embryos.
Senator Brownback. As it's practiced here in the United
States, we do, yes.
Senator Harkin. So what do you do with them?
Senator Brownback. Well, we've been through this discussion
before as well, there are adoption procedures that people can
go through--what I'm discussing here today is the creation of
an embryo just for that research purposes, which is the issue
that we're on on human cloning. And that's the one I think we
should pause on.
Senator Harkin. I'm not so certain that--and I will ask
scientists further to elaborate on this, and I'm not certain
the bioethics commission was correct in that I haven't read
that exactly. But I've been told, and I will ask further
scientists to give me the exact reading on this is, if you
implant DNA in an egg in which other DNA's been extracted, and
that develops only to the blastocyst stage, is it really
embryonic or is it not embryonic at that point? Again, I don't
know, I'm not a scientist. But I've heard that it may not be,
and I want to find that out. I don't know if that bioethics
commission was correct in that, I just don't know.
Well, I appreciate the give-and-take with you, Senator,
thank you very much. Senator Specter.
Senator Specter. Thank you, Mr. Chairman. Senator
Brownback, what we have here so far is research not to have
human cloning, not to make babies, so to speak, but to develop
tissues for treating disease. You raise a question about the
moral significance of creating an embryo, and I can certainly
understand that, where you raise a concern about having a man-
made creation of an embryo result in reproductive cloning or
the creation of another person. But it is quite another matter
where this is done for therapy. For example if someone has
Parkinson's you can have the curative stem cells derived from
an embryo that has been created in part with the DNA of the
potential recipient, someone illustratively who has
Parkinson's, so that they will not reject the stem cells, but
can, in fact, be cured. So taking away the possibility of
creating another human being, and having as a sole purpose
therapy to cure someone with Parkinson's or amyotrophic lateral
sclerosis, Lou Gehrig's Disease or many other ailments, what's
wrong with that? The embryo has significance morally if it
leads to the creation of a person. But if it's sole purpose is
for therapy, and it works, why not?
Senator Brownback. I would submit there's another route we
can go, that we are going presently that's being quite
successful, as we've discussed many times in the area of the
adult stem cell work, where the genetic match-up is identical,
where the donating person is also the person that needs the
help. And that research is moving beautifully, it's being well-
funded by the Federal Government and I support that. And I
think we should be doing that as rapidly and as aggressively as
possible.
The issue that you raise is about, well, why not just go
ahead and create this human embryo, is the very question I put
in front of you, and one I think we need to contemplate and
that is, is there any moral significance at all to that human
embryo that's being created? There is no difference physically
between it and one created naturally by God.
Senator Specter. Well, Senator Brownback, that's by no
means certain. There is considerable scientific speculation. At
the time you have this entity, there's no person involved.
There is only a procedure for curing a disease. If you strike
out the possibility of creating a person, how does that differ
from any other scientific research?
Senator Brownback. What have you created then? I mean, have
we created a human embryo or not? I guess there's dispute as to
whether we've created a human embryo or not, and you'll hear
from other testimony. I'm just reading from our own National
Bioethics Advisory Board which says that we've created a human
embryo. If that is the case, then this is a human egg that's
fertilized that in other species we protect. We protect bald
eagle eggs because we look at them, we say, well, if we don't
protect them we're not going to get any bald eagles. So these
or other endangered species we say we're going to protect these
because they lead ultimately to a full grown bald eagle. DNA-
wise, they are identical to what this bald eagle will be. We
have contemplated that as a body, and we've enacted that in
laws. What I'm saying here is that we should really contemplate
as a body, is does what we're creating here have any moral
significance? If it doesn't, if it's a piece of property, we
move on forward with it. If it does have some moral
significance, then we should grant it whatever protections that
we deem appropriate, and that this is the point for us to stop
and really chew through those, for a moratorium for 6 months,
is why I asked for that.
Senator Specter. Senator Brownback, when you talk about
adult stem cells, I'm for doing the research there. This is our
12th hearing on this subject. In the 3 years since stem cells
came forward, we've invited you to testify on a number of
occasions. But there's been a lot of scientific evidence at
that table that the adult stem cells don't have the potential
which embryonic stem cells do. But in any event, why should
these decisions be made in room 192 of the Dirksen Senate
Office Building as opposed to a laboratory? What business do we
have, as long as we don't allow reproductive human cloning, to
tell the scientists what to do?
Senator Brownback. Because this body has generally
considered issues regarding protection of rights and life, if
that is a life. And that's what this body has generally
considered. And we don't let just anybody take somebody's
else's life or, for that matter, property without consequences
in this society. We put boundaries. And what I'm simply asking
here is let's contemplate that question first, before that's
taking place in private laboratories in this country. This is
the appropriate place for it to occur. This is where the
people's business is discussed. The House has passed it and
contemplated it. The President's asking for it. This is the
appropriate place, Senator Specter.
Senator Specter. Senator Brownback, when we propose that we
could ban reproductive cloning at implantation, and you say,
how do you know that that's going to be carried out. Whenever
you have a criminal law, you don't know that it's going to be
carried out. We may pass your legislation, and someone may
totally disregard it and move right through to reproductive
cloning. Now they may run the risk of not being detected or run
the risk of penalty. So if you prohibit part of it, if you
prohibit only the second phase of implantation, you have
precisely the same chance of having an effective criminal
deterrent.
Where we have generalized agreement is on no reproductive
cloning. Why not end it there and allow science to have free
rein to try to cure Parkinson's, Alzheimer's, etc?
Senator Brownback. I am for curing Parkinson's and
Alzheimer's. I want that to be clear. I think that there is a
way that we can go about this, and I think you'll look at the
adult stem cell work today, because we've been in this debate
now for a year, it has improved marvelously--that that has
grown and that that has moved forward. But we have to
contemplate, and a number of people in this country hold very
significant, moral significance to the embryo. There's a large
cross-section of Americans that do hold that there is moral
significance to what you are laboring here, somatic cell
nuclear transfer, what our bioethics board is calling the
creation of an embryo. So I just think that the really sensible
approach here is just to pause for a while. Just pause.
Senator Specter. Senator Brownback, is there any realistic
likelihood that something's going to happen between now and
February, March, when you and I have agreed to set in motion
the mechanism where the bill will come up as a free-standing
bill? These embryos didn't even succeed by the company which
made them. Do you think there's any chance at all that
something's going to happen between December 3 and March?
Senator Brownback. Absolutely. Absolutely. I didn't know
this was being contemplated--this work was being--was going on
by this Massachusetts-based company. And I think that now that
they've started and gotten this far, I think it's very clear
that the road map has been made and that we're going to, going
to see this moving on forward quite easily, quite quickly. Even
though it may take, I think in Dolly there was 257 attempts
before you finally got to Dolly, that was there, 257
aberrations or changes, you're going to see a lot taking place
here as well. But I think that's a very high probability.
Senator Specter. Well, that is another area for
disagreement. I think the chances in the few months are just
nonexistent. Final question: when President Bush agreed to use
Federal funding on stem cells, it drew a lot of opposition--I
think opposition from you, among others--and the President has
pretty much held the line. There was an overwhelming sentiment,
as I said earlier, in the Senate to have Federal funding on
stem cells. Don't you think that, in a sense, President Bush's
recognition of the propriety of useing Federal funds on stem
cell research has moved beyond some of the moral issues which
had been raised earlier about the propriety of using these
embryos and extracting the stem cells and working for the cure
of diseases.
Senator Brownback. Absolutely not, Senator, and I want to
say as well, I generally was overall supportive, and I stated
that at the time, supportive of what President Bush put
forward. I had some questions and some concerns about certain
key areas of it, but overall--and I stated that at the time--I
thought he generally found a route where we weren't
incentivizing further destruction of what a number of people
believe is the starts of life. But now you have the President
last week himself saying: ``We shouldn't create life to destroy
it.'' It's a quote from the President. We haven't resolved the
moral issues here about the creation of life or its
destruction. Indeed the President's saying we shouldn't do
that. The House is saying we shouldn't do that. Should we have
embryo farms, as being contemplated by a company in the state
of Virginia? Where we get naturally created embryos, but that
are more vigorous and vital, is what this company is saying,
taking place. That's another issue that we really should
wrestle with. But no, I think you're just--we're wading into--
and then what about the issue when you start bringing genetic
material from outside the human species into the human species,
as some companies are contemplating? You know, clearly we ought
to be taking that up, before that's actually a reality.
Senator Specter. Well, I quite agree with you about outside
the human species and inside the human species, but your
legislation doesn't do that. And I agree with President Bush's
statement that we shouldn't create life to destroy life. But I
hardly think that we're talking about the creation of life
here. Well, Senator Brownback, I have deep respect for your
convictions, and you and I have crossed swords on this here and
in others forums, and I suspect we may well again even before
March or--when we debate it on the Senate floor. So thank you.
Senator Brownback. Thank you.
Senator Specter. Thank you, Mr. Chairman.
Senator Brownback. Thank you, Mr. Chairman.
Senator Harkin. Senator Brownback, we've talked about birth
purposes versus therapeutic purposes. I wonder if, in your
opinion, does the ultimate purpose for which a particular act
takes place affect its morality or affect its propriety? In
other words, does the intent of the person who is starting this
act or doing these things ultimately affect how we as a society
should view this particular act? It seems to me that
distinction is being made here, and we're going to hear in a
moment from further witnesses who are going to try to shed some
light on that. But I just wondered, in your opinion does that,
does the intent matter?
Senator Brownback. I don't know how you effectively draw
clear differences if you're basing it upon intent. Is there an
intent to implant or not? And yet you've still created the same
entity. I don't think you can draw effective differences based
upon the intent of the creator of the entity. So I--no, I don't
think that's an effective line to draw, and indeed, basically
that's what's taking place--here you're saying there's no
intent to implant, therefore it's not a clone. Well, then
you're making your distinction based upon what's in somebody's
thinking process, and I don't think you can effectively do that
and I don't think that's the right way for us to consider it.
Thank you, Mr. Chairman.
Senator Harkin. Thank you. Sam, before you leave, I pulled
off the Scientific American web site an article that was by Ron
Green--Mr. Green will be testifying later--and he said: ``What
is the moral status of the organisms created by cloning?'' And
basically--I'll let him read it when he comes up, but I ask--
you ought to take a look at it and read it, it's from the
November 24 issue, 2001 of Scientific American.
Senator Brownback. I'm glad those issues are being
contemplated----
Senator Harkin. And Ron Green, who wrote it, is going to
come up and testify, and I'm going to ask him--because he has a
different view of it. He said:
``We pointed out that, unlike an embryo, a cloned organism
is not the result of fertilization of an egg by a sperm. It is
a new type of biological entity never before seen in nature.
Although it possesses some potential for developing into a full
human being, this capacity is very limited. At the blastocyst
stage, when the organism is typically disaggregated to create
an embryonic stem cell line, it is a ball of cells no bigger
than the period at the end of this sentence. Embryos normally
do not attach to the wall of the uterus and begin development
until after the blastocyst stage. It has no organs, it cannot
possibly think or feel, and it has none of the attributes
thought of as human. Although Board members understood that
some people would liken this organism to an embryo, we prefer
the term `activated egg,' and we concluded that its
characteristics did not preclude its use in work that might
save the lives of children and adults.''
So there's a difference of opinion about what the bioethics
advisory commission had termed an embryo. I think these are the
things we've got to be thinking about and looking at and
getting the scientists and others to talk about and the
ethicists and others to talk about.
Senator Brownback. Well, as I stated at the outset, I have
far more questions than I have comments at this point, but
that's exactly why we should hold up here. Plus I would point
out a number of people are saying the embryo is an embryo if
it's implanted. Well that's a distinction based upon location.
And do we make that distinction anywhere else--that it's an
embryo if it's implanted, but it's not if it's not. I think
you've got to really question if you draw lines based upon
intent, which I don't think you effectively can do, or location
as well. And I'm pleased that you're, and others, are
considering these very historic type of questions and comments.
Mr. Chairman, thank you very much for allowing me to come and
discuss the issue and I have a great deal of respect for the
charge that you have here.
Senator Harkin. Thank you very much, Senator Brownback----
Senator Brownback. Thank you.
Senator Harkin [continuing]. I appreciate it.
Next we'd like to ask our panel to come up--that would be
Dr. West, Michael West, Dr. Ronald Green, Dr. Bert Vogelstein
and Ms. Phyllis Greenberger. All of your statements will be
made a part of the record in their entirety. I'd like to ask if
you could sort of summarize them in a short span of time. We'll
put the clock on for 5 minutes. But we'll be very lenient there
and--maybe 7 minutes or something like that--but if you could
summarize it so we could get into a discussion I would
appreciate that.
Dr. Michael West, we'll start with you, then we'll just go
down the line. Dr. West is the president and CEO of Advanced
Cell Technology in Worcester, Massachusetts. He received his
bachelor's degree in psychology from Rensselaer Polytechnic
Institute, his master's in biology from Andrews University and
a Ph.D. in cell biology from Baylor College of Medicine. This
is Dr. West's fourth appearance before this subcommittee. So we
welcome you back, Dr. West. As I said your statement will be
made a part of the record, so please proceed.
STATEMENT OF DR. MICHAEL D. WEST, PRESIDENT AND CEO,
ADVANCED CELL TECHNOLOGY, WORCESTER, MA
Dr. West. Mr. Chairman and members of the committee, thank
you very much for inviting me today. I would like to speak to
you both about the opportunities and the challenges we have
this year and moving into the coming years. I think we've been
seeing three major developments in the history of biology and
medicine that will impact our lives and the lives of our
children and subsequent generations in, I think, a significant
way. The first of course, which is, I think well known now, is
the sequencing of the human genome. We have a fundamental new
understanding of the blueprint of life, DNA, which will have a
profound impact on all of our lives.
I would argue a second major development is the discovery
or the isolation of the human embryonic stem cell. These cells
are, to use an analogy, the building materials of life. If you
imagine the building being constructed, and a truck driving up
full of lumber, these cells are completely undifferentiated
cells that can branch out and make any cell in the body. And of
course their importance in medicine is exemplified by the
recent report by the National Institute of Health. There's much
discussion about their relative merit compared to the adult
stem cell, but just as one simple example of their relative
benefit: the embryonic stem cell can self-assemble into a
complex tissue given the right circumstances. It can actually
form intestine and other kidney tissue, and other important
tissues--we've never seen this before in the history of
medicine. So these cells are unique and have, I think, an
important role in medicine in the future.
A third area where I think we've seen a dramatic
advancement that could be used for the benefit of humanity is
the discovery of nuclear transfer. What attracted cell
biologists and medical researchers such as myself to the
discovery of what we call cloning is not, I think, what's
popularly perceived. It's not that we could clone our favorite
race horse or hunting dog. What excites us about nuclear
transfer is that it is a means of taking a person's cell back
in developmental time, to make embryonic stem cells identical
to the patient. And of course, what this could mean is--you
know, the dream of research scientists--is that we might
finally solve this age-old problem of transplantation.
Our automobile, if the carburetor breaks, we can go to the
store and get a new one. But, as amazing as it sounds, for our
loved ones when we have a heart attack and our heart muscle
dies, until now we've never had a means of giving people back
all the cells and tissues of their own DNA type so they would
not be rejected. And this is one of the greatest promises of
the medical uses of nuclear transfer. Of course we're not
talking about cloning of humans, as has been pointed out. We're
talking about the cloning of cells.
Now it's been--the concept has been introduced, and the
concern has been introduced, what is it that we're talking
about making here? We're talking about cloned embryos. What are
these, and what should be their moral significance? I think
this is--and I share with Senator Brownback the concern over--
this is a very serious issue. I personally hold a deep respect
for the sanctity of human life. And let me say, if the
proposition was that we would clone a developing human being, I
would argue, with Senator Brownback, we shouldn't cross that
line. We have a line here. It's the primitive streak. Early in
development--what we call pre-implantation embryos--prior to
forming a pregnancy--we're talking about a little clump of
cells that has no body cells of any kind, and no cells on their
way to becoming yet a body cell of any kind. Purely the raw
material of cellular life.
The bright line, I would argue, would be a wise one for us
to draw, is primitive streak. At about the time of
implantation, this pre-implantation embryo begins the first
steps toward becoming human being, or indeed it may form two
human beings, identical twins. Primitive streak, I think, is an
effective line to draw and say that is the beginning of a human
being. And prior to primitive streak we should use some other
terminology, a pre-implantation embryo or some other such
terminology, because this is not an individualized human being.
I would like to summarize by saying and sharing the sense
of gravity on this issue. Millions of human lives hang in the
balance on these important decisions. One of the reasons I
would not recommend a moratorium is, as I calculate, in 6
months, a 6 month delay in medical research we would estimate
would cost potentially 541,800 lives that could potentially be
treated someday with these technologies.
prepared statement
And so I would argue rather than slowing medical research,
that we take the time to carefully understand these issues, as
we did IVF. We had the same, I think, knee-jerk reaction to
IVF. Isn't this Brave New World? Isn't this the kind of world
we don't want to make? But with time we came to realize that
the proposition of making in vitro fertilized embryos and
making pregnancies was a gift to mankind. It built families,
and it had in it positive benefit.
So what I would ask is, let's take the time and get this
right. Thank you very much.
[The statement follows:]
Prepared Statement of Dr. Michael D. West
Mr. Chairman and members of the Subcommittee, my name is Michael D.
West and I am the President and Chief Executive Officer of Advanced
Cell Technology, Inc., a biotechnology company based in Worcester,
Massachusetts. A copy of my curriculum vitae is presented in Appendix
A.
introduction
I am pleased to testify today regarding human embryonic stem cell
and nuclear transfer technology and their applications in medicine. I
would like to first speak to the potential benefits of this emerging
science, and then speak to some of the questions and concerns that have
been voiced.
the potential benefits of es and nt technology
Human Embryonic Stem (ES) cells are unique in the history of
medical research for at least two reasons. First, they alone are
totipotent stem cells. By stem cells, we mean cells that can branch out
like the stems of a tree, becoming other cell types. By ``totipotent''
we mean to say that they stand near the base or ``trunk'' of the
developmental tree and so are capable of forming any cell or tissue
type needed in medicine. In addition to forming any cell type, they are
unique in their ability to self-assemble into complex multicellular
tissues such as intestine, full thickness skin, kidney tissue, and so
on. They differ in this respect from adult stem cells that are
``pluripotent''--that is, capable of forming several, but only a
limited number, of cell types. One can think of adult stem cells as
limbs further out on the branches of a tree. While able to branch out
in several different directions, only the trunk of the tree branches
out into every leaf and limb. An example of adult pluripotent adult
stem cells are the bone marrow stem cells now widely used in the
treatment of cancer and other life-threatening diseases.
The second distinguishing feature of ES cells is the ease with
which they can be purposefully modified in a precise manner. This
precise genetic modification is designated ``gene targeting''. The
enhanced ability of ES cells to be modified with precision likely opens
the door to many hundreds of clinical applications making human cells
of any kind, genetically modified in any way to ``heal'' mutations in
genes, something never before possible in medicine.
These two unique characteristics of human ES cells open the door to
manifold novel therapeutic strategies. It may not be an exaggeration to
state that the combination of the ability to precisely genetically
modify these cells by targeted modifications and the ability to make
any cell type may have as profound an application in medicine as the
ability to arrange electrical components has made in the electronics
industry.
To attempt to name every disease that potentially could be treated
using this technology would require a larger report. Here are just a
few examples. Neurons could be manufactured to treat degenerative
diseases such as Parkinson's and spinal cord injury. Gene targeting to
find and ``heal'' mutations could be used to manufacture neuronal stem
cells for childhood retardation from diseases like Rett syndrome. Heart
and skeletal muscle cells could be used for heart failure and age-
related skeletal muscle wasting, and targeted genetic modification
could be useful in muscular dystrophy. Blood forming cells would be
useful in bone marrow grafting after cancer treatments, and anemias.
Precision genetic modification could lead to better therapies for
inherited blood cell disorders such as sickle cell anemia and
infectious diseases such as AIDS.
I would argue that the debate over the number of human ES stem cell
lines approved for Federal funding largely misses the point. Human ES
cells obtained from IVF preimplantation embryos are not identical to
the patient, that is they are ``allogeneic''. We should expect that
such cells derived from the 20-60 approved lines would be rejected by
the patient's immune system. The primary purpose in funding human ES
cell research is not just the pure pursuit of human knowledge, but
rather to accelerate the delivery of novel therapeutics to afflicted
people. We must address from the beginning how we are going to make
these cells useful in transplantation.
the use of nuclear transfer in medicine
The recent success in the cloning of animals from body cells
demonstrates that the transfer of a body cell into the environment of
an egg cell can ``reprogram'' it back to an embryonic developmental
state. We have recently demonstrated that such technology actually
rebuilds the replicative lifespan as well, suggesting that ``young''
cells can be derived from ``old'' cells. This is a profound development
and perhaps the ideal solution for making real the longstanding dream
of transplantation medicine; namely, to be able to offer any patient,
even an aged patient, young healthy embryonic stem cells of from which
any kind of cell could be make all of which would be their own cells,
not expected to be rejected by their immune system.
Nuclear transfer offers an important solution of the problem of
tissue rejection. Every year many thousands of people die for the
inability to liver, kidney, or other tissue with the right
constellation of markers to allow it to accepted by the body as self.
It is estimated that three thousand people a day die from degenerative
disease potential addressed by therapeutic cloning. This new procedure
would begin with the patient donating living cells to a physician, who
would then reprogram them back to a totipotent state using the cloning
procedure. This is called therapeutic cloning, to distinguish it from
reproductive cloning which is designed to clone an entire human being.
Therapeutic cloning does not involve the cloning of a human being, it
involves the medical use of cloning to make living cells. The cells and
tissues made from these cloned stem cells would be expected to be
grafted stably for the life of the patient without immunosuppression.
responses to concerns and objections
(1) The preimplantation embryo is a human life and to use
therapeutic cloning is to ``clone and kill''.
Answer. In the first few days following the fertilization of an egg
cell by a sperm cell, there develops a microscopic ball of cells called
a preimplatation embryo. This embryo is destined to die unless it
implants in the uterus to form a pregnancy. Indeed, it is estimated
that 50-80 percent of these preimplantation embryos naturally formed in
a woman's body never implant and therefore die, naturally. Prior to day
14, the preimplantation embryo has no body cells of any kind, and, in
fact, has no cells even committed to somatic cell lineages. Indeed, the
embryo has not individualized. Once this ball of cells attaches to a
uterus, one or even two or more individuals can form from it. It is
therefore proper to say that it is not yet an individual. At ACT, we
neither allow cell development beyond day 14, nor do we implant the
cells in a uterus.
(2) Therapeutic cloning is merely theoretical; there is no reason
to suggest it will work.
Answer. There are published reports of success of therapeutic
cloning research in at least two mammalian species; namely mice (1-2).
While never performed in a human, the animal data suggests that
therapeutic cloning has great promise. The National Academy of Sciences
has formally recommended in a report titled ``Stem Cells and the Future
of Regenerative Medicine'' as follows:
``Recommendation: In conjunction with research on stem cell biology
and the development of potential stem cell therapies, research on
approaches that prevent immune rejection of stem cells and stem cell-
derived tissues should be actively pursued. These scientific efforts
include the use of a number of techniques to manipulate the genetic
makeup of stem cells, including somatic cell nuclear transfer.''
(3) Allowing therapeutic cloning would cause a ``slippery slope''
effect, whereby regulating human reproductive cloning would not be
possible.
Answer. In reality the procedures to clone a human being are well
known in the scientific literature. The widespread use of therapeutic
cloning would not significantly increase the likelihood of the success
of an effort to clone a human being. In addition, laws can easily be
written to allow one and prohibit the other as reproductive cloning
requires the transfer of a cloned preimplantation embryo into a uterus.
(4) Therapeutic Cloning will lead to ``embryo farms''.
Answer. Therapeutic cloning guidelines could easily be constructed
to limit development to less than 14 days as is the current practice
with in vitro fertilization.
summary
In conclusion, nuclear transfer and human embryonic stem cell
technology offer novel pathways to develop lifesaving therapies that
will impact the lives of millions suffering from such diseases as
Parkinson's disease, diabetes, arthritis, heart disease, kidney
failure, spinal cord injury, liver failure, skin burns, blood cell
cancers, to name only a few. The gravity of this issue calls for a
compassionate, reasoned, and dispassionate debate. History will judge
us harshly if we as a society fail to recognize and deliberate
carefully upon a medical technology that could so powerfully alleviate
the suffering of our fellow human being.
______
Somatic Cell Nuclear Transfer Technology is Justified and Essential for
Producing Embryonic Stem Cells for Basic Research and Therapeutic
Applications
Since 1997 The American Society for Cell Biology has stated and
stood by its strong opposition to the reproductive cloning of human
beings. Media claims notwithstanding, current scientific information
suggests that the technology now available will not be able to lead to
the creation of a cloned human being or to an embryo capable of being
born as a cloned normal human. Equally important, no responsible
scientist favors reproductive cloning.
It is unlikely that current biomedical technology can be used to
clone adult human beings. But there is substantial justification to
believe that somatic cell nuclear transfer (SCNT), or what many have
referred to as therapeutic cloning, will energize scientific progress
in the fight against the most debilitating illnesses known to man. New
embryonic stem cell lines, potentially capable of avoiding the
rejection complications of stem cell therapies for cancer, diabetes,
spinal cord injury, kidney disease, and Parkinson's disease, may be
produced by using the genetic material of the prospective transplant
recipient to generate recipient-matched stem cells. These procedures
could be vital in solving the persistent problem of a lack of
genetically matched, qualified donors of organs and tissues that we
face today. Stem cell research is an essential first step if we are
ever to be able to achieve the promise of regenerative medicine, a
wholly new approach for repairing cells and tissues in the treatment of
currently intractable human diseases. Beside the therapeutic promise,
the SCNT procedure permits entirely new approaches to the study of the
earliest phases of human development, of how a single cell is
transformed into the trillions of different cells and tissues with
myriad fates and capabilities during embryonic development. By deriving
embryonic stem cells with defined mutations scientists gain a new
approach to understanding how such inherited predispositions lead to
serious disease in adulthood.
Unfortunately, an onerous cloud has been cast on the term cloning
because it has been used in the public discourse both to refer to
attempts to create genetically identical adult humans and to describe
other procedures that are less controversial. However, cloning is a
scientific term that describes the preparation of an ``infinite''
number of copies of, for example a single molecule, cell, virus or
bacterium. For example, cloning DNA molecules was essential for solving
the human genome sequence. Similarly, cloning DNA is critical to fight
against bioterrorism and has already been used in the determination of
the entire genome sequences of several organisms identified as
bioweapons. Furthermore, cloning is integral to modern forensic
procedures, medical diagnostics, vaccine development, and the discovery
and production of many of the most promising drugs. Cloning is also
used to make genetically identical plants and livestock enabling
continued agricultural breakthroughs necessary to feed a rapidly
growing and undernourished world population.
Conflating the term cloning as it is used for the creation of
genetically identical humans with the valuable and appropriate uses of
cloning embryonic stem cell lines for basic research and therapeutic
purposes is inappropriate. The two issues need to be considered
separately; otherwise we run the serious risk of sacrificing certain
great benefits to prevent a perceived undesirable practice.
Senator Harkin. Thank you, Dr. West. Senator Specter has to
go to another committee, but wanted to ask a question or two
before he left. Normally I'd go through the whole panel, but
I'm going to interrupt right here and let Senator Specter----
Senator Specter. Well, thank you very much, Mr. Chairman.
The Judiciary Committee is meeting on the military tribunals
and I'm going to have to excuse myself for a few minutes and
I'll come back as soon as I can. But I wanted to question you a
bit here, Dr. West. Picking up on the number of lives which you
said could be saved in the intervening 6 months, what is the
basis for you conclusion on that?
Dr. West. That's based on the number that approximately
3,000 people die a day, every day, from degenerative diseases
that could potentially be treated with these technologies.
Senator Specter. So you think you could save a total of how
many lives? And it will be--the delay would cost how many
lives?
Dr. West. It's a large number, because----
Senator Specter. What figure had you just said?
Dr. West. 3,000 a day.
Senator Specter. So you made a calculation of 541,000, more
than a half million lives would be lost by a 6 month delay?
Dr. West. Obviously we're not talking about therapies that
would be available next week, next month, next year, but a
delay would have that impact someday on----
Senator Specter. On the results that you reported, the
embryos did not live. Is there any chance at all of human
reproductive cloning in a 6 month period? Any chance at all?
Dr. West. Reproductive cloning? I don't think so.
Senator Specter. Creation of a human being.
Dr. West. Well, I mean, there's always some measurable
chance. But the cloning of a human being, in my own
professional opinion, I don't believe that that's at all a
likely outcome.
Senator Specter. Dr. West, where the example has been used
about taking the genetic material out of an unfertilized egg
and illustratively taking some skin tissue from somebody who
has Parkinson's, and placing that in the egg and then
implanting it--could that result in having a human being
created? If so, what if the donor of the DNA is a woman, is
that possible, scientifically?
Dr. West. If the donor of the DNA is a woman?
Senator Specter. Yes.
Dr. West. Could a woman clone herself, you mean, or
through----
Senator Specter. Well, the donated egg comes from woman,
obviously. Then you have a woman who has Parkinson's, and you
get a DNA specimen from that woman who has Parkinson's, and you
put that in the donated egg--can that then be implanted in a
woman and create a baby?
Dr. West. I think your diagram is very accurate. As far as
we know today, both branches of that diagram are possible. So
we believe, indeed, it would be--as best as we know today,
possible.
Senator Specter. Even if the DNA from the Parkinson's
patient comes from a woman?
Dr. West. If I understand your example correctly, once
you've made a pre-implantation embryo by nuclear transfer, if
that embryo was transferred into a uterus in an attempt to
establish a pregnancy, which obviously it is not at that point,
pregnancy would be possible.
Senator Specter. Even though you have a woman who has
donated the egg, and you have a woman whose DNA is transplanted
to the donated egg, you can create a baby?
Dr. West. As I understand your question, yes.
Senator Specter. The answer then is yes?
Dr. West. If the cell, the DNA from the sick patient is,
you know, healthy DNA, then you would expect that you could
create a healthy baby by transferring----
Senator Specter. And it doesn't matter that the DNA comes
from a woman?
Dr. West. No. No, indeed Dolly the sheep was cloned from a
female.
Senator Specter. Thank you very much. I'll come back as
soon as I can.
Senator Harkin. Okay, thank you very much, Senator Specter.
Now we turn to Dr. Ronald Green. Dr. Green's been a member of
Dartmouth University Faculty for 20 years. He is now the
director of the Ethics Institute and Chair of the Religion
Department. Dr. Green graduated from Brown University and
received his Ph.D. in religious ethics from Harvard University.
Now Dr. Green, I didn't mean to quote you earlier, but I had
read that article in Scientific American, so I decided to go
ahead and quote it, but--again, welcome, and please proceed.
STATEMENT OF DR. RONALD M. GREEN, PROFESSOR, DARTMOUTH
COLLEGE
Dr. Green. Thank you for doing so, Senator Harkin. Good
morning to Senator Harkin and the other members of the
committee. As has been indicated, I am a professor of religion
at Dartmouth College, where I also chair the Ethics Institute.
As a matter of public service, I serve as head of the Ethics
Advisory Board, or EAB as we call it, of Advanced Cell
Technology in Worcester, Massachusetts. ACT's scientists
recently announced that they had successfully produced the
first cloned human organism. I want to report to you on some of
the ethical reflections that led the members of ACT's EAB to
endorse this research. Above all, I want to signal a crucial
difference between what has been called reproductive cloning
and the kind of so-called therapeutic cloning research in which
ACT is engaged.
Reproductive cloning, as has been said today, aims at the
birth of a child. ACT has never pursued this goal. All the
members of ACT's EAB believe that at this time reproductive
cloning in human beings is too risky to be responsibly pursued.
In addition, most EAB members believe that many other difficult
ethical questions would have to be answered before reproductive
cloning could ever be justified. Therapeutic cloning is an
entirely different matter. This is the kind of research ACT is
conducting. Therapeutic cloning involves the use of nuclear
transfer or cloning technology to produce immunologically
compatible human stem cell lines. If therapeutic cloning
research is successful it will mark the beginning of a new era
in medical science.
You have all heard about the promise of human stem cells,
the basic building blocks from which almost any tissue in the
human body could be fashioned. This summer, President Bush
authorized Federal funding for research using a limited number
of human stem cell lines. However, the problem with these and
any other stem cells is that the patient's body would see them
as foreign tissue. The result could be rejection. Therapeutic
cloning offers a way around this problem. In the future, the
mother of a child suffering from juvenile diabetes could donate
an egg from one of her ovaries. A cell could be scraped from
the inside of the child's cheek. Using a cloning procedure it
might then be possible to produce a stem cell line that could
be coaxed to differentiate into new insulin-producing cells.
These could be injected back into the child's body, where they
would not likely be rejected. The child would be spared a life-
threatening disease.
The members of ACT's EAB came to the conclusion that this
research direction is important and ethically sound. On the one
hand, we believe that the life-saving promise of this research
constitutes an important ethical consideration in its favor. On
the other hand, as we reviewed the biological qualities of
these cloned organisms, we concluded that they could not be
equated morally with the children or adults whose lives could
be saved by therapeutic cloning research. We noted that these
clusters of cells lack most of the qualities we normally equate
with a human life. They are not the result of the union of
sperm and egg. They represent an entirely new kind of
biological organism, never before seen in nature. They have no
differentiated cells, and cannot think or feel. Because
spontaneous twinning is still a possibility at this very early
stage of development, they are not yet human individuals.
We acknowledge that others may come to different
conclusions about the moral status of this very early form of
human life. We doubt, however, that there is a moral consensus
in our society about this matter or likely to be one soon. In
view of this, we concluded that privately funded researchers
and scientists should be free to continue with this research on
the basis of their own conscientious beliefs.
The primary message I have tried to communicate today is
that therapeutic cloning and reproductive cloning are two
different things. Some will object, however, that there is a
slippery slope here, that therapeutic cloning could lead to
reproductive cloning. For two reasons, the members of the ACT
EAB did not share this fear. First, we believe that open and
publicly discussed research like this may actually reduce the
chances that unscrupulous researchers will pursue reproductive
cloning. It could do so by highlighting the physiological
dangers of reproductive cloning. ACT's research shows that
cloned human organisms are extraordinarily fragile. Second, we
do not agree that shutting down therapeutic cloning research is
an effective way of blocking reproductive cloning. The best way
to do that now is by imposing and enforcing a strict ban on
reproductive cloning. Adding therapeutic cloning to the
prohibition will only result in the loss of the medical
benefits that therapeutic cloning research can bring. If I may
use an analogy, banning therapeutic cloning in order to stop
reproductive cloning is a little bit like halting all air
travel in order to prevent hijacking.
prepared statement
The members of ACT's EAB stand ready to share our ethical
debates and conclusions with you and the members of the public.
Thank you very much for inviting me here today.
[The statement follows:]
Prepared Statement of Dr. Ronald M. Green
Good morning. I am Ronald M. Green, a professor at Dartmouth
College in Hanover, New Hampshire, where I head the Department of
Religion and direct the Ethics Institute. As a matter of public
service, I also serve as chair of the Ethics Advisory Board (or EAB) of
Advanced Cell Technology in Worcester, Massachusetts. The EAB is an
independent body of ethicists and health care professionals brought
together by ACT to provide guidance and oversight for the company's
research.
ACT's scientists recently announced that they had successfully
produced the first cloned human embryo. This accomplishment is the
first step in the company's effort to use nuclear transfer (cloning)
technology to produce replacement cells or tissues that would not be
subject to rejection by a patient's body. The ACT EAB provided
oversight for this research. I am here to report briefly to you on some
of the ethical reflections that led us to endorse, with careful
consideration, the research in question.
Above all, I want to signal a crucial difference between what is
called ``reproductive cloning'' and the kind of ``therapeutic cloning''
research in which ACT is engaged.
Reproductive cloning aims at the birth of a child. ACT has never
pursued this goal. All the members of ACT's EAB agree that at this time
reproductive cloning in human beings is too risky to be responsibly
pursued. Cloned animals in many species have evidenced problems during
gestation or following birth. Until further research establishes the
likely safety of cloning in human beings it would be irresponsible to
try to bring a human child into the world in this way. In addition,
most EAB members believe that many other difficult ethical questions
would have to be answered before reproductive cloning could ever be
justified.
Therapeutic cloning is an entirely different matter. It involves
the use of nuclear transfer (cloning) technology to produce human stem
cell lines. To accomplish this, a cloning procedure is used to produce
a small cluster of early dividing cells similar to but not the same as
a normal human embryo. Because these cells are produced by nuclear
transfer, they are not the product of fertilization. They represent an
entirely new kind of biological organism never before seen in nature.
Following international guidelines, ACT's EAB laid down strict rules
for the handling of these organisms, including the requirement that
none be allowed to develop beyond fourteen days. We also insisted upon
intensive security and monitoring procedures to insure that no cloned
organisms could be diverted to reproductive purposes.
If ACT's research on therapeutic cloning proves successful, it will
mark the beginning of a new era in medical science. You have all heard
about the promise of stem cells, the basic building block cells from
which almost any tissue in the human body can be fashioned. This
summer, President Bush authorized Federal funding for research using a
limited number of stem cell lines already in existence. However, the
problem with these and any other stem cells is that the patient's body
would see them as foreign tissue. The result would be rejection, or,
worse, a very serious toxic crisis. To minimize these problems,
patients could be given immunosuppressive drugs. But these drugs carry
their own risks because they expose the patient to infections or the
risk of developing cancer.
Therapeutic cloning promises a dramatic way to avoid all of these
problems. In the not-too-distant future, the mother of a child
suffering from severe Type I juvenile diabetes could donate an egg from
her own ovaries. A cell could be scraped from the inside of the child's
cheek. Using the kind of nuclear transfer procedure being researched
now by ACT, it might then be possible to produce a stem cell line that
could be coaxed to differentiate into new insulin-producing cells.
These cells could be injected back into the child's body, where they
would provide an entirely new pancreatic system. Because these cells
are made from the child's own genetic material, they would not be
rejected. The child would be spared a life-threatening disease often
accompanied by amputations or blindness.
I should note that therapeutic cloning is only a transitional
technology toward the long-term goal is direct cell reprogramming. We
know that in the nuclear transfer procedure something almost magical
happens when a differentiated cell nucleus is placed inside an egg.
Substances in that egg return the nuclear DNA to its embryonic state
and prepare it to become any cell type in the body. If cloning research
helps scientists to understand these processes, the cloning step might
be skipped. A cell could be taken from any of our bodies and directly
induced to become primordial nerve, blood, muscle or skin tissue. By
means of both therapeutic cloning and eventually direct cell
reprogramming, we might realize the Biblical vision of the lame walking
and the blind seeing.
ACT's EAB came to the conclusion that this research direction is
important and ethically sound. On the one hand, we believe that the
lifesaving promise of this research constitutes an important ethical
consideration in its favor. On the other hand, as we reviewed the
biological qualities of these cloned organisms, we concluded that they
could not be equated morally with the children or adults whose lives
could be saved or health restored by therapeutic cloning research.We
noted that these clusters of cells, while arguably worthy of some
respect, lack most of the qualities we normally equate with a human
life. They are not the result of the union of sperm and egg. They lack
differentiated cells and cannot think or feel. Since spontaneous
twinning is still a possibility at this very early stage of
development, they even lack individuality. It is true that they could
potentially go on to full development if placed in a womb. But in an
era of cloning technology, this statement is true of every cell in our
body. Surely we would not want to declare every human cell or tissue
off limits to research.
We acknowledge that others may come to different conclusions about
the moral status of this very early and novel form of human life. We
doubt, however, that a consensus now exists in our society about this
matter. In view of this dissension, we concluded that privately funded
researchers and scientists should be free to proceed with this research
on the basis of their own conscientious beliefs. We hope that the
Senate will agree.
The primary message I have tried to communicate today is that
therapeutic cloning and reproductive cloning are two different
endeavors. Some will object, however, that there is a slippery slope
here, that therapeutic cloning will lead inevitably to reproductive
cloning and the birth of a human clone. Again, after considering this
matter carefully, the members of the ACT EAB did not agree. Two
considerations moved us.
First, we believe that open and publicly discussed research like
this may actually reduce the chances that unscrupulous researchers will
pursue reproductive cloning. It could do so by highlighting the
physiological dangers of reproductive cloning. Most of the cloned human
embryos produced at ACT died within hours of the nuclear transfer
procedure. They are extraordinarily fragile and vulnerable organisms.
Even if it is possible eventually to produce a stem cell line from
these entities, as ACT researchers hope to do, it will be years before
we understand all the genetic factors that are necessary for a healthy
pregnancy and birth. Irresponsible researchers will certainly try to
beguile women or couples into cooperating with reproductive cloning
research by promising them a healthy child. ACT's published research on
therapeutic cloning can help to better inform such couples of the
gravity of the risks.
Second, we do not agree that shutting down therapeutic cloning
research is an effective way of blocking reproductive cloning. The best
way to do that now is by imposing and enforcing a strict ban on
reproductive cloning. Adding therapeutic cloning to the prohibition
will add little force to it and will additionally result in the loss of
the medical benefits that therapeutic cloning research can bring. If I
may use a readily understandable analogy, I believe that trying to stop
reproductive cloning by banning therapeutic cloning is a little bit
like trying to prevent hijacking by halting all air travel. The members
of ACT's EAB stand ready to share our extensive ethical debates and
conclusions with you and other members of the public. Thank you very
much for inviting me here today.
Senator Harkin. Thank you very much, Dr. Green. Now we'll
turn to Dr. Bert Vogelstein. Dr. Bert Vogelstein is a professor
of oncology and pathology at Johns Hopkins University, a leader
and international expert and pioneer in the field of molecular
genetics. He received his medical degree in 1974 from Johns
Hopkins, where he's also completed his internship and
residency. He joined the Johns Hopkins faculty in 1978. Dr.
Vogelstein.
STATEMENT OF DR. BERT VOGELSTEIN, PROFESSOR OF ONCOLOGY
AND PATHOLOGY, JOHNS HOPKINS UNIVERSITY,
BALTIMORE, MD
Dr. Vogelstein. Thank you, Mr. Chairman, all the members of
the committee. I take to heart Senator Specter's directive to
scientists to help clarify the issues in this debate. I think
it is our responsibility to do so. In particular, my goal today
is to try and clarify the differences between these very
different procedures: one-cloning and second, regenerative
medicine. And towards that goal I'd like to today propose a
different name for the second procedure, the name nuclear
transplantation. I think that has significant advantages over
other names that have been used to describe parts of this
procedure, such as therapeutic cloning, which is really not
accurate, is a misnomer, or somatic cell nuclear transfer,
although scientifically accurate, it's a mouthful.
In contrast, nuclear transplantation is both perfectly
accurate and, in addition, has the connotation of
transplantation. That's what this scientific procedure is used
for, much like bone marrow transplantation, heart
transplantation, liver transplantation. The sole purpose of
this procedure is to produce cells for transplantation.
Now I'd like to explain some of the scientific differences
between these two procedures. What is a clone? A clone is an
exact copy of an organism. The organism could be a fruit fly,
it could be a mouse, it could even, perhaps, be a human. In the
movie ``Multiplicity'' clones were created. Those were real
clones, at least on the movie screen. There's a difference
between clones and cells. Let me illustrate those differences
by comparing what we could do with cells taken from me. I could
take a--skin cells from a little biopsy or cheek cells, or I
could even take a hair. Now, is that hair a clone of me? It's
not such a trivial question, because each cell in the hair is
genetically identical to me, to every other cell in my body,
and moreover, the cells in that hair have the potential to be
me. It used to be, just a few years ago, thought that there was
a strict line between the potential to form human life and
human life, and that potential was only in embryos. But we now
know that every living cell in an animal's body could at least
potentially be used to create human life. And it's very
important to discriminate the potential for human life from
real human life.
Let me give you some more examples that will emphasize
these distinctions. This hair--is it a clone of me? Well, it
can't walk, it can't talk, it can't be educated, it can't marry
my wife, it can't father my children--it can do none of the
things that we equate with human beings, and it would be
clearly wrong to look or consider the cells in this hair as a
clone--they are not.
Now, what else could we do with the cells from this hair? I
could put them in a culture dish. I could grow millions of
cells that were genetically identical to that hair or the cells
from the hair. And, interestingly enough, I could use nuclear
transplantation to create a variety of other cell types
different from the hair that I could do even more interesting
things with. Why would I do that? If I had Alzheimer's Disease
or Parkinson's Disease or a variety of other degenerative
diseases for which there was no other cure I might want to make
such cells from that hair cell in a test tube. But these other
cells are no more a clone of me than were the cells in the
hair. There's a huge difference between the cells derived from
me and a clone of me.
And furthermore, it's important to point out that one of
the reasons I might wish to do this is that other forms of stem
cells, such as those approved by President Bush on August 9th,
could not do the same thing. Any of those other 64 lines, if I
used them for transplantation purposes to try to correct a
degenerative disease would not do the trick, they would be
rejected, because they are not derived from me, they are not
genetically identical to me.
prepared statement
I urge you then to deeply consider the differences between
nuclear transplantation and human cloning, and to consider the
enormous impact on research and, indeed, patients' lives if a
ban on nuclear transplantation were to be enacted. President
Bush's announcement on August 9th to allow Federal funding for
research on existing stem cell lines was a giant step in the
direction toward realizing the promise of stem cells in
regenerative medicine. To ban nuclear transplantation would be
a giant step backwards in this effort. Thank you, and I'd be
glad to try to answer any questions.
[The statement follows:]
Prepared Statement of Dr. Bert Vogelstein
Good morning, Mr. Chairman, and members of the Committee. My name
is Bert Vogelstein, and I am a Professor of Oncology and Pathology at
the John Hopkins Oncology Center and a Howard Hughes Medical Institute
Investigator. I am here today as the chairman of a National Research
Council and Institute of Medicine Committee on the Biological and
Biomedical Applications of Stem Cell Research that recently released
the report: ``Stem Cells and the Future of Regenerative Medicine.''
My goal today is to clarify some of the confusion surrounding two
very different medical endeavors; the first is regenerative medicine,
and the second is the cloning of a human being. Regenerative medicine,
which as a field is in its infancy, involves growing cells and tissues
for implantation in people with diseases or injuries to their organs,
for example diabetes, Parkinson's disease, heart disease, and spinal
chord injury. The most promising avenue of regenerative medicine is the
use of embryonic stem cells for eveloping tissues of many different
types for transplantation into patients with these diseases or
injuries.
A substantial obstacle to the success of transplantation of any
cells, including stem cells and their derivatives, is the immune
reaction of a patient's body to cells that it perceives as foreign. Our
report recommended that multiple approaches to reducing this problem be
explored, including ways to manipulate the genetic makeup of the stem
cell tissue to make it less likely to provoke an immune reaction, the
creation of a large bank of diverse stem cell lines, and the
development of embryonic stem cells using a technique known as somatic
cell nuclear transfer. This involves taking the DNA from a cell of a
patient in need of a transplant, inserting it into an egg cell that has
had its nucleus removed, and triggering cell division. The resulting
stem cells and tissue that can be obtained from this procedure would be
genetically identical to the patient's cells, and would in theory not
be rejected by the patient's immune system when transplanted into him
or her.
This procedure for producing embryonic stem cells that are
genetically identical to the donor's tissue should not be confused with
human cloning, which has the goal of creating a human being. In that
endeavor, the DNA from the cell of an individual would be inserted into
an egg cell that has had its nucleus removed, and that embryo would be
implanted into a woman's uterus so that it would grow into a child who
is genetically identical to the individual whose DNA was inserted into
the egg.
Unfortunately, the notion that genetically identical stem cells are
the same as a genetically identical human being has obfuscated the
important potential of developing transplant therapies with lower
probabilities for rejection, and greater chance of helping improve the
health of many sorts of patients.
There has been much confusion surrounding the terminology common to
the causes of both regenerative medicine and those who wish to clone
human beings. Because the term ``therapeutic cloning'' has been used by
different sources to mean both the cloning of human beings and the
production of embryonic stem cells genetically identical to their
donor, it has become effectively useless. And because the term
``somatic cell nuclear transfer'' smells of scientific jargon, I
propose the use of the term ``nuclear transplantation'' be entered into
the debate over cloning legislation.
I urge lawmakers to deeply consider the differences between nuclear
transplantation and human cloning, and to consider the enormous impact
on clinical research, and indeed patients' lives, if a ban on nuclear
transplantation were to be enacted. President Bush's announcement last
August to allow Federal funding for research on existing embryonic stem
cell lines was a great step in the direction toward realizing the
promise of stem cells in regenerative medicine. To ban nuclear
transplantation would be a step backwards in this effort.
Our committee is respectful of the wide array of social, political,
legal, ethical, and economic issues that must be considered in policy-
making in a democracy, and we have been impressed by the commitment of
all parties in this debate to life and health, regardless of the
different conclusions they draw. It should be recognized that a large
number of citizens oppose human cloning at the same time they support
embryonic stem cell research and regenerative medicine. We hope our
report, by clarifying what is known about stem cells and how best to
realize their potential, will be a useful contribution to the
discussion of this important issue.
Thank you for this opportunity to testify. I would like my
statement to be put into the record, and I will be happy to answer any
questions the Committee might have.
Senator Harkin. Dr. Vogelstein, thank you very much for a
very, I think, fairly presented concept. Now we turn to Ms.
Phyllis Greenberger. Greenberger is the first president and CEO
of the Society for Women's Health Research, a Washington, D.C.-
based advocacy organization formed in 1990 to utilize medical
research to improve the health of women. Ms. Greenberger
received her bachelor's degree from Syracuse University and a
master's from Catholic University here in Washington, D.C. Ms.
Greenberger, welcome and please proceed.
STATEMENT OF PHYLLIS E. GREENBERGER, PRESIDENT AND CEO,
THE SOCIETY FOR WOMEN'S HEALTH RESEARCH,
WASHINGTON, DC
Ms. Greenberger. Good morning Mr. Chairman and members of
the subcommittee. As you said, I'm Phyllis Greenberger,
president of the Society for Women's Health Research, and I
appreciate the opportunity to present this morning. And also,
as you said, our mission is to improve the health of women
through research.
For the last 10 years the Society has spoken out on
important scientific issues that advance research on women's
health, and have the potential to alleviate suffering and
improve the quality and longevity of life. Today's discussion
about therapeutic cloning is no exception. The Society is
deeply concerned about any impediments that would slow research
in regenerative medicine. This area of research has the
potential to treat a range of confounding human diseases and
health disorders, many of which are prevalent in or
disproportionately affect women.
The specter of human reproductive cloning clouds the
potentially enormous benefits of this new area of research. The
future benefits are being overshadowed by a new cycle of
ethical and political debate. We must carefully distinguish
between creating an entire human being and therapeutic cloning,
which, used in conjunction with new stem cell research, has the
potential to produce new diagnostics, medicines and vaccines.
Research on human stem cells derived from both adults and
embryos provides the most efficient and responsible means to
fulfilling the promise of regenerative medical research for
achieving medical breakthroughs. The Society for Women's Health
Research believes that the potential of therapeutic cloning for
treating and perhaps curing a variety of debilitating diseases
demands that the scientific community be allowed to continue
this promising work. Unfortunately, if the Senate were to pass
the cloning prohibition act, HR 2505, this research would be
prohibited.
Many of these research advances are critically important to
women. We are on the cusp of putting into everyday medical
practice many promising techniques. Investigators are
evaluating the use of embryonic stem cells to treat
incontinence. Stem cell tissue engineering has been used to
restore urethral sphincter muscles in animal models. This lays
the foundation for further investigative methods to use stem
cells to treat urinary incontinence. Urinary incontinence
affects 35 percent of American women over the age of 50. This
kind of stem cell research is also being used to transplant or
replace damaged cells in Parkinson's Disease. Studies in animal
models have shown that embryonic stem cells derived from neural
cells can be used successfully to treat nervous system
disorders. Mouse embryonic stem cells which were stimulated to
differentiate into neural cells, when transplanted into mice
with neurological disorders helped to restore normal function.
Heart muscle cells known as cardiomyocytes do not regenerate
after being damaged by a heart attack and are replaced with
non-functioning scar tissue. Each year more than 1 million
Americans, more than half of them women, will have a heart
attack, which is the primary cause of heart muscle damage.
Therapeutically treated cardiomyocytes in animal tests have
been shown to replace heart tissue and successfully reintegrate
into the animal's heart.
We should also not overlook the fact that this field of
research may also improve the way we develop and test new
drugs. These drugs could be tested on liver cells or skin
cells, and only those drugs that are safe and effective would
be advanced for testing in humans.
Embryonic stem cell research is in its infancy and holds
tremendous promise. An enormous amount of research must be done
before it can be translated into medical treatments, but we
should carefully weigh the implications of any roadblocks that
might derail it. Any impediments would have serious
implications for medical research. Pharmaceutical and
biotechnology companies that have the resources to translate
these breakthroughs into medical treatments would be reluctant
to invest in this research if serious roadblocks were created.
We recognize that this research is controversial. But
therapeutic cloning should not be confused with reproductive
cloning. Never is there any intention of implanting the
resulting embryo to produce a child. In therapeutic cloning the
nucleus of an egg cell is removed and genetic materials are
inserted from the transplant recipient, triggering cell
division. This new technique goes a long way to overcoming
tissue rejection, an important breakthrough in organ and tissue
transplantation.
I believe it is important to point out that both the
National Institutes of Health and the National Academy of
Sciences recently noted that the use of this technique will
lead to promising new techniques for patients. We understand
the fundamental ethical dilemmas and scientific uncertainties
raised by therapeutic cloning. The Society concurs with the
National Academy of Sciences, which in late November created a
national advisory committee made up of leading scientists,
ethicists and other stakeholders to be established at the
National Institutes of Health. This group is charged with
ensuring that proposals for Federal funding to work on
embryonic stem cells are justified on scientific grounds, and
meet current and future federally mandated ethical guidelines.
The NIH in the past has set up similar watchdog panels
including a recombinant DNA admonitory committee which oversees
the once-controversial genetic engineering research. The
Society agrees with a recent Washington Post editorial which
said that barring all therapeutic cloning would likely drive
research underground, and guarantee that only the most
unscrupulous would advance these technologies.
prepared statement
We urge you to take time and carefully weigh appropriate
options for promoting public policy that best serves the
nation. A rush to judgment would be premature, and has the
potential for impeding much-needed and potentially beneficial
research. Thank you very much, Senator.
[The statement follows:]
Prepared Statement of Phyllis E. Greenberger
Good morning, Mr. Chairman and members of the subcommittee. I am
Phyllis Greenberger, president of the Society of Women's Health
Research. For over 10 years the Society has spoken out on important
scientific issues that advance research on women's health and have the
potential to alleviate suffering and improve the quality and longevity
of life.
Today's discussion about therapeutic cloning is no exception. The
Society is deeply concerned about any impediments that would slow
research in regenerative medicine. This area of research has the
potential to treat a range of confounding human diseases and health
disorders, many of which are prevalent in or disproportionately affect
women.
The specter of human reproductive cloning clouds the potentially
enormous benefits of this new area of research. The future benefits of
regenerative medicine are being overshadowed by a new cycle of ethical
and political debate. We must carefully distinguish between creating an
entire human being and therapeutic cloning, which used in conjunction
with new stem cell research, has the potential to produce new
diagnostics, medicines and vaccines.
Research on human stem cells derived from both adults and embryos
provides the most efficient and responsible means to fulfilling the
promise of regenerative medical research for achieving medical
breakthroughs.
The Society for Women's Health Research believes that the potential
of therapeutic cloning for treating and perhaps curing a variety of
debilitating disease demands that the scientific community be allowed
to continue this promising work. Unfortunately, if the Senate were to
pass the Cloning Prohibition Act, H.R. 2505, this research would be
prohibited.
Many of these research advances are critically important to women.
We are on the cusp of putting into everyday medical practice many
promising techniques.
Investigators are evaluating the use of embryonic stem cells to
treat incontinence. Stem cell tissue engineering has been used to
restore urethral sphincter muscles in animal models. This lays the
foundation for further investigative methods to use stem cells to treat
stress urinary incontinence. Urinary incontinence afflicts 35 percent
of American women over the age of 50. Approximately 60 percent of women
with incontinence will have stress incontinence.
Embryonic stem cell research is also being used to transplant or
replace cells damaged in Parkinson's disease. Studies in animal models
have shown that embryonic stem cells derived from neural cells can be
used successfully to treat nervous system disorders. Mouse embryonic
stems cells were stimulated to differentiate into neural cells which,
when transplanted into mice with a neurological disorder, helped to
restore normal function.
Heart muscle cells, known as cardiomyocytes, do not regenerate
after being damaged by a heart attack and are replaced with
nonfunctioning scar tissue. Each year more than one million Americans-
more than half of them women--will have a heart attack which is the
primary cause of heart muscle damage. Therapeutically treated
cardiomyocytes in animal tests have been shown to replace heart tissue
and successfully reintegrate into the animal's heart.
We should also not overlook the fact that this field of research
may also improve the way we develop and test new drugs. These drugs
could be tested in liver cells or skin cells and only those drugs that
are safe and effective would be advanced for testing in humans.
Embryonic stem cells research is in its infancy and holds
tremendous promise. An enormous amount of research must be done before
it can be translated into medical treatments. But we should carefully
weigh the implications of any roadblocks that might derail this
research.
Any impediments would have serious implications for medical
research. Pharmaceutical and biotechnology companies that have the
resources to translate these breakthroughs into medical treatments
would be reluctant to invest in this research if serious roadblocks
were created.
We recognize that this research is controversial. But therapeutic
cloning should not be confused with reproductive cloning. Never is
there any intention of implanting the resulting embryo to produce a
child. In therapeutic cloning the nucleus of an egg cell is removed and
genetic materials are inserted from the transplant recipient triggering
cell division. This new technique goes a long way to overcoming tissue
rejection, an important breakthrough in organ and tissue
transplantation.
I believe it is important to point out that both the National
Institutes of Health and the National Academy of Sciences recently
noted that the use of this technique will lead to promising new
treatments for patients.
We understand the fundamental ethnical dilemmas and scientific
uncertainties raised by therapeutic cloning. The Society concurs with
the National Academy of Sciences, which in late November created a
national advisory committee made up of leading scientists, ethicists
and other stakeholders to be established at the National Institutes of
Health.
This group is charged with ensuring that proposals for federal
funding to work on embryonic stem cells are justified on scientific
grounds and meet current and future federal mandated ethical
guidelines. The NIH in the past has set up similar watch dog panels
including the Recombinant DNA Admonitory Committee which oversees the
once controversial genetic engineering research.
The Society agrees with a recent Washington Post editorial which
said that barring all therapeutic cloning would likely drive research
underground and guarantee that only the most unscrupulous would advance
these technologies. We urge you to take time and carefully weigh
appropriate options for promoting public policy that best serves the
nation. A rush to judgment would be premature and has the potential for
impeding much needed and potentially beneficial research.
Senator Harkin. Thank you, Ms. Greenberger. Thank you all
again for being here and for your statements. I'll start with
my time of 5 minutes, then I'll recognize the senator, Senator
DeWine.
Dr. West, let's start with you. Just a few weeks ago your
company, ACT, indicated that you were able to take out the DNA
from the donated egg, you took DNA from another donor--I don't
know from what, where you derived that DNA--and you replaced it
in the egg, but that it only developed into four or five cells.
Could you elaborate on that? Now, the reason I'm asking is
that--some have said that what you did was not all that
significant, that this is not a big breakthrough, that the
breakthrough will come when you actually are able to develop
that into the blastocyst stage. Could you respond to that,
please?
Dr. West. Right. What we reported on were the first steps
towards demonstrating that this technique will work in humans.
It's previously--us and others have demonstrated that this
technique appears to work in mouse--where mouse skin cells were
taken back to an embryonic state by nuclear transfer, making
Parkinson's neurons and other types of cells. And we
demonstrated this in a cow, as well--that you could reprogram a
cell back in time using nuclear transfer.
On a human, we just reported that the first evidence is
that we believe this will work. What were those evidences? One,
what happens to the DNA of a body cell when you put it into an
egg cell is, it is reprogrammed, like when you put a disk into
a computer and you say ``initialize,'' it takes it back to its
blank state, this embryonic state. And when a somatic cell,
body cell nucleus is put into an egg cell and reprogrammed, it
takes on a certain kind of shape and appearance, called the
pro-nucleus. And we reported----
Senator Harkin. A pro or cro----
Dr. West. Pro-nucleus it's called. And we reported that, as
evidence that--again, preliminary evidence, very preliminary,
but--first steps that this is--the DNA is being reprogrammed,
we reported that we saw pro-nuclear development.
No. two, we reported that we got the beginnings of cell
divisions. Now obviously we would need to get these cells to
divide to some one hundred cells, we think, to effectively take
the step of making stem cells and then making medically useful
cell types. We also reported on some related observations, what
we call parthenogenesis, which is a whole separate discussion
and a separate way of making stem cells directly from an egg
cell.
The reason we reported on this without having taken the
technology all the way through to showing that we could make
stem cells and medically important stem cells, is in the spirit
of transparency. We felt that it was important for us to
publish often, every step, so we disclosed early on that we had
arranged for egg cell donors to provide us with egg cells, and
we decided that we would report each step of the way. Similar
to the way in IVF, back some twenty years ago, Bob Edwards in
publishing on the production of human embryo as an idea, first
reported a paper that the sperm cell has penetrated the egg,
and then another paper on -he'd gotten the embryo to divide
once, and then another paper when he divided to make an embryo,
and of course, finally, the production of the baby.
Senator Harkin. Now let's get something secure and on the
record. What you did is right now not against the law--there's
no law against what you did.
Dr. West. That's correct.
Senator Harkin. As I understand it there is no law against
taking it the next step. In other words, if you were to take
the DNA and put it into an egg from which the donor egg's DNA
had been removed, and you were able to grow that into the
blastocyst stage and to remove stem cells, there is no legal
ban on that now, either?
Dr. West. As far as I understand.
Senator Harkin. That's my understanding, I'm just wondering
if any of you have any different understanding of that, Dr.
Green, is that correct?
Dr. Green. I believe that is correct, there is no law
that----
Senator Harkin. Yes, I believe that's also correct, there's
no Federal funding for it, but there's no law against it, for
private entities to continue on down that course.
You told us two or three years ago you were doing this. I
mean, it was not anything you didn't tell us, that ACT was
going to be working on. I assume that you are proceeding to
perfect the technique for the extraction of stem cells. My
question is, what kind of timeline do you see for that, when
you would actually have that kind of breakthrough where you
could actually reach the blastocyst stage, remove the stem
cells, and then regenerate them?
Dr. West. It's a difficult question to answer. We just
reported yesterday in a meeting at the Society for Regenerative
Medicine some now rather old research on nuclear transfer in
non-human primates. When we move from one species to another
like the recent effort to try to clone pigs, we saw obstacles
in making this technology work, and then suddenly by altering
the laboratory--you know, the recipe, the media that these
cells are grown in, so on, suddenly we get successful results.
It's difficult to predict. And I would hesitate to----
Senator Harkin. Could you do it in the next month or two?
Dr. West. You know, I would--let me say it this way: I
would be disappointed if we could not publish another paper,
scientific paper showing that we had successfully made heart
muscle cells, neurons for Parkinson's and so on, using this
technology, sometime in the next 6 months or so. I'd be
disappointed if we couldn't do that in that timeframe.
Senator Harkin. That's quite promising. Senator DeWine.
Senator DeWine. Thank you, Mr. Chairman. Dr. Green you--let
me quote from your written statement, and then I'll want to ask
you a question if I could.
``We concluded that they could not be equated morally with
the children or adults whose lives could be saved or health
restored by therapeutic cloning research. We noted that these
clusters of cells, while arguably worthy of some respect, lack
most of the qualities we normally equate with a human life.
They are not the result of the union of sperm and egg. They
lack differentiated cells and cannot think or feel. Since
spontaneous twinning is still a possibility at this very early
stage of development, they even lack individuality.''
And that's the end of the quote. During that period of
time, are--this cluster that you refer to, is it
distinguishable in any way from a cluster that would have been
formed as a result of the conventional union of the sperm and
egg? From a scientific point of view, not knowing how it
started, is it distinguishable in any way? Or could that
statement have been true about a cluster that was formed in the
traditional way.
Dr. Green. Well, I think apart from the fact that the DNA
is wholly from one individual, and there may be subtle
differences at the DNA level, probably not. It might look like
the result of fertilization.
Senator DeWine. So my question, my point is, when you say,
``they lack differentiated cells'' that would be true.
Dr. Green. That's correct.
Senator DeWine. They can't think. Or feel. And spontaneous
twinning is still a possibility. So from a--however you come
down on this issue--and obviously this is--I think we've had a
very good discussion and debate here. There is no real
distinction between what you have described and what we would
see from the normal union of sperm and egg other than what you
just said about the DNA. I just want to make sure I understand
from a scientific point of view----
Dr. Green. I think that is correct, Senator----
Senator DeWine. That's all, if anyone disagrees they can
jump in, but just, from a scientific point of view I wanted to
make sure I understood what we were----
Senator Harkin. Will the Senator yield on that point, then?
I do have a question.
Senator DeWine. Well sure, Mr. Chairman, certainly.
Senator Harkin. No, I was just wondering because I had to
get cleared up in my head, too, then, because the Senator's
asked a very pertinent question, very important question.
As I understand it, if you have an egg from a woman, it has
her DNA in it, in the nucleus. If that is fertilized in the
normal sexual manner, by the sperm from the man, that has the
DNA of the man, and those two combine.
Dr. Green. That's correct.
Senator Harkin. If, however, you remove the DNA of the
woman, and you replace only the DNA of a man or a woman, just
one, then it is something different.
Senator DeWine. Well, it's genetically different, right?
Its DNA is different.
Dr. Green. The DNA is not the immediate result of the union
of sperm and egg, it is the DNA from the individual who is the
cell donor initially. And furthermore, I think, right down to
the genetic level there may be subtle differences that we're
not aware of, given the origin of that nuclear DNA. So I'm
unprepared to say it is exactly identical, but my point in
making this observation is that, traditionally we have thought
of an embryo--if I were to ask you five years ago or two years
ago ``what is a human embryo?'' you'd say, well, it is the
product of human fertilization and it has these other qualities
and characteristics. These cloned entities, these organisms,
are not the product of fertilization. Their inception, their
origin, is completely different. They are novel in nature in
that regard.
Now they have some of the qualities that we liken to an
embryo, although there are subtle differences as well. All of
this, it seems to me, challenges the use of the term embryo in
this case--I'm not clear that the term is an appropriate one.
Beyond that I would say this, that the question of how embryos
are to be treated, even embryos, is a very disputed one in our
society, there is no consensus----
Senator DeWine. Absolutely, Dr. Green, and I totally--I
totally acknowledge that. My only point was, this debate is a
debate that we have had before, and I suspect people that felt
that there was great moral implication to be given to that
cluster, as you referred to, before, will still feel, as I do,
that there is great moral implication for this same cluster. I
don't know that we have changed the--the debate's a little
different, but I suspect that we have not changed the moral
arguments, nor have we changed the ethical arguments that are
involved here. What I was trying to do is, frankly, get beyond
a label and get to a question of what, from a scientific point
of view, are we dealing with. And what I take away from, Mr.
Chairman, from your testimony, Dr. Green, is that we're dealing
with a different origin of this cluster, but at least so far we
can't see much difference in what we are looking at from a
scientific point of view at that point. The DNA source is
different, but your testimony as I hear it is that there is not
really a fundamental difference.
Dr. Green. Well----
Senator DeWine. So it doesn't seem to me--the conclusion I
make--and everyone is going to have their different opinion--is
that we're back--we're into the same moral dilemma and moral
debate, where honest people can certainly disagree, about what
moral weight to assign to that.
Dr. Green. But Senator----
Senator DeWine. I'm afraid we have not escaped that debate.
Dr. Green. But if I may say so, the origin, I don't think,
is morally insignificant. As Dr. Vogelstein has remarked, in
era of cloning technology, every single cell in our body has
the potential to be equated with these clusters of cells. Yes,
it would, in that case be one cell, but it has a similar
potentiality to go on to further development and so on.
So the problem here is that all of our terms, all of our
ways of thinking, have been scrambled, really, by technological
and scientific advances.
Senator DeWine. They are changed--and I'm just trying to
get the facts. And in fact, Dr. West, in a transcript from a
recent NBC interview, actually--I'll quote him. You use the
term embryo ``talking about a cluster of cells far smaller than
the head of a pin with no body cells of any kind, the embryo
hasn't even decided if it's going to become one person or
two.'' So it's understandable that we get into a question of
labeling, and my questioning to you all was simply trying, Mr.
Chairman, to get beyond that. And I see my red light's been on
for a couple minutes, so I'll----
Senator Harkin. I interrupted you, so----
Senator DeWine. No, no that's fine. Thank you very much.
Senator Harkin. This is an interesting pathway that Senator
DeWine has opened up. Back to the question of, you know, when
does life begin. It seems to me that the egg has life. Sperm
has life. I mean, they're alive, they're not dead. I mean, if
you look at them under a microscope they're very much alive.
Dr. West. May I speak to that? I think that's a very
important point. We need to make a distinction between human
cellular life and the beginnings of a human being. So a sperm
cell is alive, and an egg cell is alive. The union of the egg
and the sperm cell is alive, but the important point which
we're trying to, I think, focus on is pre-implantation embryos,
some--estimates are 50 to 80 percent of them may naturally,
through sexual means, never find a home in a uterus, never
attach, and therefore never begin to develop. So they begin to
develop upon implantation, in the formation of a pregnancy. And
if they never find a home in the uterus--in fact, the majority
of such embryos never attach--they never begin to develop, and
they stay in this, it's like a blank, you know, a blank sheet
of paper.
And our point is, there is such a convenient line, a bright
line that we could draw, which is drawn for us by nature
itself. It's called primitive streak. So once this cluster of
cells attaches and finds a home in the woman's uterus, to begin
pregnancy, nature begins by drawing a line on those cells. It's
called primitive streak, it's the first--it's sort of the spade
in the ground, you know, the ceremonial spade to start the
construction of a building. It's the first step toward the
production, the beginnings of a human life. A human life, as
opposed to what was cellular life.
And indeed, of course, our point is two lines can be drawn
on that same cluster of cells making identical twins. I think
this tells us something very significant. There is a line, it's
a bright line that nature's given us for the beginnings of a
human being, from what was just cellular life--the hairs that
Dr. Vogelstein spoke of, the hair cells, living cells. And this
line has been useful----
Senator Harkin. Say again, what is that line?
Dr. West. Primitive streak. And it occurs at about fourteen
days. It's about the time when the embryo implants. We don't
say that that's an important line because of implantation, per
se. It's just that, about the time of implantation this also
occurs. So when the pre-implantation embryo finds a home and
begins the pregnancy, then it starts to develop into a human,
or two humans.
And so that's been an important distinction for IVF. It's
been debated widely in medical ethics. And so the concept is,
when we create pre-implantation embryos by IVF, the
understanding is we would never take those embryos in culture
beyond 14 days. Because that's when we would expect the
beginning of the development of a human being out of what is
just merely cellular life.
Senator Harkin. Dr. Vogelstein.
Dr. Vogelstein. Yes, I think you're right about two things.
First of all, there's no clear line between cells that have the
potential for life and those that don't any longer--any live
cell has the potential for full human life at least in theory.
I think the most important line is the one you drew there.
It's the legislative line. And the reason that's important is
because it's easy--it legislatively, as apart from
scientifically, to draw that line, and say ``No implantation.''
That will totally preclude human cloning. You could say ``No
development of blastocysts past the 64 or 128 cell stage.'' You
could say that every blastocyst should be destroyed after the
inner cell mass has been removed to create stem cells. Any of
those legislative mandates or dictates would totally preclude
human cloning and still, as you said, help for patients.
Senator Harkin. Is there a better one than just saying that
it would be prohibited from being implanted? You mentioned a
couple of others which I don't know that I understand----
Dr. Vogelstein. I think yours is the best, because that's
the easiest to monitor. In order for implantation you obviously
need all kinds of people involved, including a woman. Not just
a laboratory worker. So I think yours is excellent and the
best.
Senator Harkin. I just didn't know if there was maybe
another approach on this. Now, Dr. Vogelstein, I just wanted to
ask you, and perhaps others, too. You made a very good case
when you took your hair out and you said this hair is a clone
of me, it has all the cells in it that basically, that you
have. And theoretically I assume you could take the cells from
that hair and implant it into an egg and make a clone of you.
It's theoretically possible, I guess.
Dr. Vogelstein. Yes, and what I meant--I tried to ask the
question, are those cells from the hair or from my skin really
a clone of me. And the point I wanted to make is, even though
they are genetically identical, and even though they have the
theoretical potential to form me, with a lot of procedures,
they are not a clone of me. As Dr. Green said, they have none
of the characteristics of a human being.
It's essential to distinguish a human being from human
cells. They are two very different beasts.
Senator Harkin. My second 5 minutes is up.
Senator DeWine. I have nothing further.
Senator Harkin. Well, if you have anything, just interrupt
me at any time. I have a couple more things I wanted to--one
area I want to cover, Ms. Greenberger, with you is--in his
testimony Senator Brownback quoted one woman as saying that
this research would compromise women's health. That's one part.
The other part was just that in a meeting I had last week with
some individuals, we talked about how to get these eggs you
have to pay women. How does that enter into the whole process
here? Now again, the guidelines have been that you can't make
money off of this, but obviously you still can pay for a woman
to donate her eggs, I guess? I assume that's how ACT did it----
Dr. West. That's correct. That's right.
Senator Harkin. I just wonder, from your standpoint--how do
you see this in terms of affecting women's health, and sort of
the status of women as it pertains to the donors of these eggs.
Ms. Greenberger. Well, first of all, obviously I disagree
with the quote from Senator Brownback about it compromising
women's health, it--my testimony's been clear that we see great
potential for many of the diseases that disproportionately
affect women, that this would be a great stride forward. So I
don't know, obviously, what was behind that quote, but we
certainly disagree with that.
In terms of paying for embryos, I think, as you know, and
have said, that women can do that. There are certain
restrictions on you not--you can't donate for yourself, you
have to know--you can't use--there are certain Federal
regulations that protect a woman and protect the embryo. And I
think that, you know, along with legislation that's going to be
passed, if it is, concerning this, that those stipulations
would be included also. And I think women can make their own
decisions. They don't need to be told what to do and how to do
it. That they're capable of making their own decisions, and if
they feel that they want to donate their eggs to research, then
they should be able to do that. And if they want to help their
own child or someone in their family or themselves, that they
should be able to do that.
So I think--and we know, certainly, in terms of IVF and
surrogate mothers, I mean, there are a lot of things that we
accept now that, when we first discussed them years ago, people
found sort of abhorrent and strange to imagine. But now it's
accepted, and we seem to have been able to work with it.
Senator Harkin. All of you have mentioned in vitro
fertilization and I asked Senator Brownback whether or not he
was in favor of in vitro fertilization, and I think his answer
was he saw nothing wrong with in vitro fertilization.
I came across this article, it was in the paper here on
November 30. It's an op-ed piece, so it's an editorial about
this, in which the writer, Michael Kinsley, quoted the
President saying: ``We should not as a society grow life to
destroy it. It is morally wrong, in my opinion.'' End quote.
And yet, the President also earlier, in August supported in
vitro fertilization, on his August 9 television address. The
President praised IVF as ``a process which helps so many
couples conceive children.''
And the article went on to say that there's a web called
Healthfinder.gov. Didn't know it existed. But it's under the
Department of Health and Human Services. And evidently,
according to this article, that the first item on
Healthfinder's list of references about IVF is a brisk
discussion, published in the New England Journal of Medicine,
of how many eggs should be fertilized to produce an embryo. How
many should be implanted in order to maximize the chance of
producing one baby and no more? Or put it another way, how many
embryos should you create and kill outside the many embryos--
how many should you implant and hope all but one die? Seems to
me if you're in favor of in vitro fertilization, then you're
going to create more embryos than obviously can be implanted in
the woman. There's going to be some left over. What do you do
with those? I think I asked the Senator about that, he said
something about adoption and things, but I have a feeling that
most of those will be destroyed, I think a lot of them are
frozen now, but are they going to be frozen for 50,000 years or
5,000 years or what?
Seems to me here a decision is made that the benefits to
humankind, that is, the happiness and wellbeing of a couple to
have a child far outweigh any of the other perceived, real,
moral obligations or moral dilemmas regarding the destruction
of the embryos that are left over.
And so, when we get to nuclear transplantation, then it
seems that that same argument might just carry over, I would
think. I mean, you're developing it into stem cells to help
save lives and make peoples' lives better. And in the process
destroying--whether it's even an embryo or a pre-embryo, I'm
still not clear on that in my own mind, exactly what it is. But
it seems like you almost have the same kind of balancing act
there as you do with in vitro fertilization. I don't know, I
just say that, and open it for any kind of discussion that you
might want to----
Mr. Vogelstein. The problem perhaps lies in the phrase--it
sounds like a catchy phrase, create life to destroy it, which
no one would be in favor of. But the real purpose of nuclear
transplantation is to create life to save lives. It's to save
the lives of sick people. That to me is a much more accurate
and reasonable way to look at it.
Senator Harkin. It's an interesting twist to put on it,
yes. Dr. Green?
Dr. Green. Senator, I think your observation is a correct
one. Apparently many thousands and thousands of couples
routinely create what they know are spare embryos that will not
be transferred to a womb, and they freeze them, and eventually
they discard them--thousands have been discarded. They make the
decision that the opportunity to have a child for their family
outweighs those claims of those very early entities. Others may
not agree with that, and not engage in that. Others may feel
that contributing an embryo, a frozen embryo for example--ACT
has received inquiries from individuals who have frozen embryos
who--which they wish to donate for human stem cell research,
and they say that the saving of a life of a child suffering
from diabetes or whatever actually weighs far more in their
thinking than simply having a child.
So I think there is a range of views about this. That's the
reality. I don't think we're going to change anybody's opinion
on that in 3 months, 6 months. Our society permits individuals
to make those decisions right now. Whether to make more embryos
than they need to have a pregnancy, whether to make an embryo
for the purpose of assisting research--and we had many egg
donors, incidentally, this is one of the more interesting
findings of the work of the Ethics Advisory Board.
We found that there were many women out there who were
perfectly willing to donate an egg for lifesaving research,
because they had family members who suffered from these
diseases, but who would never donate an egg for reproductive
purposes, because they didn't want to create a child with that
egg, they wanted primarily to help save lives.
Those differences exist, they are not going to change, and
I think that we can permit that kind of research going forward
on the basis of what we all--the differences we all share now,
without going the other route toward reproductive cloning. We
can stop that and draw that line.
Senator Harkin. Dr. Vogelstein, one last question, I'll
recognize Senator Specter. Go ahead.
Senator Specter. Thank you. George Annas, who is a very
well-known bioethicist who participated in our workshop
addressed exactly the point you raise, and he gave what I
thought was a very interesting example. He said, suppose you
were in a room that on one side of the room had a dish of stem
cells derived from a human blastocyst, say from in vitro
fertilization, clearly have the potential for life. And on the
other side of the room, there was a 30-year-old individual in a
wheelchair, a policeman who was injured on the job and had a
spinal cord injury. And suppose there was a fire in the room,
and you could save one. Which would you save? I thought that
was an interesting question.
Senator Harkin. I think that kind of puts it really in
perspective. I'm going to pursue that, that's a good thought.
I just want to say before I close down my questions, I know
Senator Specter wants to engage in some dialogue with you.
Dr. West, I just want to make sure I heard correctly
earlier, that you would be disappointed if there were not some
derivations of cell lines that already had been differentiated
into different types, differentiated into different types of
cells, muscle cells, neuron cells--you would be disappointed if
that had not been done within the next 6 months.
Dr. West. That's correct.
Senator Harkin. Is that correct?
Dr. West. Yes----
Senator Harkin. I would have thought you'd have said that
you'd have been disappointed if within the next 6 months you
were not able to reach the blastocyst stage----
Dr. West. Yeah, well----
Senator Harkin. Now I find that you said 6 months not only
to reach that, but the extraction of stem cells and the
differentiation of those cells.
Dr. West. Yes. The----
Senator Harkin. I just wanted to make sure I heard it
correctly.
Dr. West. You heard it absolutely correctly.
Senator Harkin. Well, I don't know about the press here,
but I think that's about the most important thing that I've
heard this morning. I mean, that really does push the envelope.
Dr. West. You're asking a question that scientists always
hesitate to answer, you know, it's so hard to predict the
future of science and how fast things will develop, because
they aren't all within our control. So the only way I've found
that I can effectively answer that is to tell you my own
anticipation as measured by--I would be disappointed, and
that's based on, you know, the work that was done on both the
mouse system and the cow, is to related mammals where we--based
on those kinds of timeframes, we could generate successful
results. That's my hope, and anticipation, but science moves at
an unpredictable rate.
Senator Harkin. Sometimes you have these serendipitous-type
happenings that things happen and moves everything ahead light
years----
Dr. West. That's right.
Senator Harkin. And other times you go along for a long
time. I understand that. But I find that exhilarating, quite
frankly, that it's moving that rapidly. That gives even more
hope to people who are suffering from Parkinson's Disease and
spinal cord injuries that, in fact, this is not too far beyond
the horizon.
Dr. West. Its been said that, you know, we should remember
that many ideas fail. So going from the blackboard into the
hospital--we can't take every step and successfully deliver a
therapy. But given the breadth of this technology, I think it
would be unwise for us not to recognize that there are likely
going to be some applications that will prove lifesaving.
Senator Harkin. Well, just for my own part, I just, I would
just say that, rather than a moratorium, I feel very strongly
what we ought to do is to speak very clearly and simply, as Dr.
Vogelstein said, to absolutely ban the implantation, put severe
restrictions, penalties on that. But I think we ought to
promote and support as much as we can the nuclear
transplantation, the somatic cell nuclear transfer, to derive
those stem cells. To me that would be the proper course for us
to take, and to move ahead aggressively in that manner.
Senator Specter welcome back.
Senator Specter. Well, thank you, Mr. Chairman, I regret
the necessity to leave as this hearing is in process. As I said
earlier, we're hearing testimony on military tribunals, and on
the floor, I had an issue of importance to Pennsylvania on the
Transportation appropriations bill. The Department of Defense
is also being marked up on subcommittee, so although this is a
matter of great importance, we have to balance it with a lot of
other concerns.
I want to come back to the issue about how many people are
likely to die as a result of a 6 month delay. I have not heard
a quantification of what the stem cell research means and the
benefits of nuclear transfers. Dr. West, I had asked you about
that very briefly before I had to leave. Could you amplify your
thinking on the calculation of three thousand people die a day?
How did you come to that figure?
Dr. West. The estimates are that 3,000 people die a day of
degenerative diseases that could be potentially treated by cell
or tissue transplantation.
Senator Specter. When you say degenerative diseases, does
that include heart disease?
Dr. West. Yes, heart attacks, myocardial infarction,
congestive heart failure----
Senator Specter. Include cancer?
Dr. West. Renal failure, liver failure----
Senator Specter. Includes cancer?
Dr. West. That's a good question. I frankly don't know. I
wouldn't think so, but I couldn't speak to that for sure. I
don't know. Dr. Vogelstein knows.
Senator Specter. Dr. Vogelstein, what do you think about
that estimate?
Dr. Green. I think that--without being able to say that
this 500,000 identifiable people's lives will be saved--I think
that would be mistaken. I think it would be wrong to say that
there are people out there now whose lives certainly will be
saved--say that we could point to. But I think the
understanding that every day of delay puts off for young
children, for example, a cure to diabetes, so that in the
period of, say, 3 or 4 years a child may die who might have
reached the point that that therapy was available.
And therefore I think it's not unreasonable to say that
every day here is a lifesaving day if it can be gained. Even if
it was one person.
Senator Specter. Ms. Greenberger, do you concur that each
day has very substantial risks of many, many people dying?
Ms. Greenberger. Well, obviously I don't know as much about
this as the other testifiers do, but certainly every day that's
a delay in terms of finding the cures or the treatments for
people suffering from these diseases, obviously makes a
difference. I think for young children it's certainly,
especially for them, but also--and I have a good friend that
has Parkinson's, my mother has Parkinson's, I think the sooner
we can find a cure or successful treatments--you know, every
day, every day, every day that it takes is another day of agony
for these people.
Senator Specter. Dr. Vogelstein I appreciated the comment
in your statement that the term somatic cell nuclear transfer
is excessive scientific jargon. Actually you said it smells of
scientific jargon. And you suggest the term nuclear
transplantation, maybe even simpler nuclear transfer. To
eliminate the word cloning in therapeutic cloning might be
enormously helpful in having the people understand that.
You also made a comment about the advances where the
President had authorized the use of Federal funding on stem
cell research. Do you have an opinion as to the adequacy of the
so-called 64 lines? We've had a good bit of information which
we had a hearing on here, but in the popular media, in the news
media, about some of those cells being insufficient. Do you
think that stopping as of 9 p.m. on August 9 of this year will
be sufficient to provide the stem cell lines for all the
productive research?
Dr. Vogelstein. Yes, in our report we made a strong
statement about that. The statement was that the President's
remarks certainly opened the way to do research, which was an
excellent first step. But there were many reasons to feel that
other types of research to produce new stem cell lines would be
needed to take this area from strictly the research arena to a
clinical arena. And one of those areas in particular involved
nuclear transplantation.
Perhaps a good way to put this is, our job as scientific
advisors was simply to try and predict what would be the best
way to win this war against these diseases. And if military
advisors were to say that one couldn't use jet planes against
an adversary, or couldn't develop the technology to manufacture
jet planes against the adversary, they wouldn't be very good
military advisors. And we looked at our job in the same way. As
scientific advisors we felt that the best way to make this
research practicable in the clinic would be to approach several
avenues including nuclear transplantation.
Senator Specter. And that would require additional stem
cell lines beyond the so-called 64 available----
Dr. Vogelstein. Yes. Yes, it would require lines derived
from nuclear transplantation as well as perhaps other lines
derived by more conventional techniques for a variety of
reasons.
Senator Specter. Well, quantification would be enormously
helpful in our public deliberation, in our Senate debates, so
until Dr. West had advanced the figure of 541,800 lives lost
over a 6 month delay or moratorium on nuclear transfer, I
hadn't heard a quantification. I think it would be very helpful
if we could have some judgment as to what is being lost by the
failure to use Federal funding on stem cell research. Senator
Harkin and I have taken the lead for many years on increasing
the NIH budget, as you all know. And concluding this year's
appropriation we'll have $11 billion dollars added to $12
billion. And if we could have some idea as to quantifying what
that means in saving human lives, and what it means in the
therapeutic process, it could be a very powerful tool in our
debate. Because that really boils it down. I would very much
appreciate it if you would give thought to that. I'm not going
to ask you for judgment at all here today, but that would be
enormously helpful, if these additional funds were put to use
on stem cell research and therapy. Dr. West, you have your hand
up?
Dr. West. Yeah, I was just going to say, this is one
example of why it might be wise for us to consider using other
lines and having Federal funding apply to them. We now know
that it's possible to make embryonic stem cells or embryonic
stem-like cells from egg cells that are activated, as we say,
parthenogenetically, where the egg cell, without removing its
DNA, is turned into a pre-implantation embryo, making embryonic
stem cells that come from just an egg cell on its own. It's a
new technique that we're working on. And those cells, because
they are derived entirely from a female source, whereas you and
I are made from DNA from a male and female source, they have a
unique difference, a change in what's called ``imprinting,''
which is sort of like when you highlight text in a book with a
magic marker. The genes are marked as being whether they're
coming from male or female sources. Those cells would be
important for medical research, and would not--under the
current guidelines you could not have Federal monies apply.
Also there are congenital or inherited genetic disorders
that are now--we're beginning to be able to take a cell from a
pre-implantation embryo and determine that that embryo has the
gene for muscular dystrophy, you know, both bad genes. So that
embryo then is not implanted into the uterus to prevent a
pregnancy with that particular problem. Well, those could be
used to generate embryonic stem cell lines. And then those
neurons and other cells made from that source would display,
before the laboratory researcher, that particular genetic
problem in the laboratory dish.
And so all these could be very important tools for medical
research in the future. And unfortunately, because they would
be made from future embryos, no Federal funding could apply.
Senator Specter. Dr. West, there's an article which appears
by Dr. Harold Varmus in today's New York Times captioned ``The
Weakness of Science for Profit.'' Have you had a chance to see
that?
Dr. West. No, I have not.
Senator Specter. Well, the article by Dr. Varmus, who used
to be head of NIH, raises a number of points. I'd like to ask
you about two of them.
Dr. West. Sure.
Senator Specter. He raises a question about the public
disclosures which your firm made, suggesting that, while
entirely appropriate within our free enterprise system, that
the disclosures were early in terms--or premature in terms of
where you were, and that he understands that that kind of
publication, or that kind of attention is very helpful in
getting additional investors so you can pursue your work, but--
what would your comment be as to the consideration that you
jumped the gun a little, with all that publicity--why the
number of counter-attacks and whether it was really right for
public disclosure.
Dr. West. Well, what we decided is that the application of
nuclear transplantation or nuclear transfer in medicine--we
knew that there's a considerable amount of public concern as to
where these technologies go. And so we went back and took a
lesson from history in the development of in vitro
fertilization. There were the same concerns. Brave New World
concerns, you know, where are we going with this technology.
And the researchers who developed in vitro fertilization
decided to publish in a very transparent manner, and to publish
frequently. And indeed were criticized for similar reasons.
So when the first egg cell was successfully combined with a
sperm cell and the sperm cell entered the egg cell, they
published that data. They hadn't created an embryo, they hadn't
created a pregnancy, but they wanted to frequently show what
work was being done in their laboratory, and that's the policy
we've decided to take. We recognize that our fellow scientists
who like to see data published in a more complete form after
certain milestones are met may find fault with us and the way
we did this. But we felt it was important to be transparent and
publish our data as frequently as we possibly could. And so
that's why we published.
Senator Specter. And Dr. Varmus makes one more point, that
understanding what you did, that it is not desirable to have
the private sector solely conduct the research, and notes that
in vitro fertilization has not been financed by any Federal
funding. Dr. Varmus emphasizes the point that there really at
least ought to be public financing. And with the tremendous
sums which NIH now has as a result of the increase in funding,
that rings loud and clear. Anybody disagree with the conclusion
of the Federal Government ought to use the resources which the
congress has appropriated to try to move ahead with stem cell
research. May the record show that people are just nodding in
the negative. Thank you very much, Mr. Chairman.
Senator Harkin. Thank you very much, Senator Specter.
Senator DeWine.
Senator DeWine. Nothing further, Mr. Chairman.
Senator Harkin. Well again, thank you all very much for
your attention to this matter. It's one of the most important
issues I think confronting the American people--all humankind,
I believe, in the broadest context. And I just hope that we can
find our way clear through this, and to continue to try to
develop those cures and therapies that will help so many people
that suffer from these diseases. So I compliment you for the
work you're doing. I encourage you and I urge you on, and I
hope that we can perhaps at least approach it from this
standpoint so that we can continue to develop the nuclear
transplantation stem cell derivations that hold so much promise
for people, at the same time preventing the implantation and
the cloning of a human being. Thank you.
conclusion of hearing
The subcommittee will stand in recess until the call of the
Chair.
[Whereupon, at 11:15 a.m., Tuesday, December 4, the hearing
was concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]
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