[Senate Hearing 109-815]
[From the U.S. Government Publishing Office]
S. Hrg. 109-815
ALTERNATIVE PLURIPOTENT STEM CELL THERAPIES ENHANCEMENT ACT (S. 2754)
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HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
__________
SPECIAL HEARING
JUNE 27, 2006--WASHINGTON, DC
__________
Printed for the use of the Committee on Appropriations
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COMMITTEE ON APPROPRIATIONS
THAD COCHRAN, Mississippi, Chairman
TED STEVENS, Alaska ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico PATRICK J. LEAHY, Vermont
CHRISTOPHER S. BOND, Missouri TOM HARKIN, Iowa
MITCH McCONNELL, Kentucky BARBARA A. MIKULSKI, Maryland
CONRAD BURNS, Montana HARRY REID, Nevada
RICHARD C. SHELBY, Alabama HERB KOHL, Wisconsin
JUDD GREGG, New Hampshire PATTY MURRAY, Washington
ROBERT F. BENNETT, Utah BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas RICHARD J. DURBIN, Illinois
MIKE DeWINE, Ohio TIM JOHNSON, South Dakota
SAM BROWNBACK, Kansas MARY L. LANDRIEU, Louisiana
WAYNE ALLARD, Colorado
J. Keith Kennedy, Staff Director
Terrence E. Sauvain, Minority Staff Director
------
Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
JUDD GREGG, New Hampshire DANIEL K. INOUYE, Hawaii
LARRY CRAIG, Idaho HARRY REID, Nevada
KAY BAILEY HUTCHISON, Texas HERB KOHL, Wisconsin
TED STEVENS, Alaska PATTY MURRAY, Washington
MIKE DeWINE, Ohio MARY L. LANDRIEU, Louisiana
RICHARD C. SHELBY, Alabama RICHARD J. DURBIN, Illinois
ROBERT C. BYRD, West Virginia (Ex
officio)
Professional Staff
Bettilou Taylor
Jim Sourwine
Mark Laisch
Sudip Shrikant Parikh
Candice Ngo
Lisa Bernhardt
Ellen Murray (Minority)
Erik Fatemi (Minority)
Adrienne Hallett (Minority)
Administrative Support
Jeff Kratz
C O N T E N T S
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Page
Opening statement of Senator Arlen Specter....................... 1
Statement of Senator Rick Santorum............................... 2
Prepared statement........................................... 3
Prepared statement of Senator Tom Harkin......................... 5
Statement of James F. Battey, Jr., M.D., Ph.D., Director,
National Institute on Deafness and Other Communication
Disorders, and Chair, NIH Cell Task Force, National Institutes
of Health, Department of Health and Human Services............. 11
Prepared statement........................................... 13
Statement of Alan I. Leshner, Ph.D., chief executive officer,
American Association for the Advancement of Science............ 15
Prepared statement........................................... 17
Statement of Stephen Strom, Ph.D., professor, department of
pathology, University of Pittsburgh............................ 18
Prepared statement........................................... 19
ALTERNATIVE PLURIPOTENT STEM CELL THERAPIES ENHANCEMENT ACT (S. 2754)
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THURSDAY, JUNE 27, 2006
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:05 a.m., in room SD-192, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Stevens, Harkin, and Durbin.
Also present: Senator Santorum.
opening statement of senator arlen specter
Senator Specter. Good morning, ladies and gentlemen. The
Appropriations Subcommittee on Labor, Health and Human
Services, Education, and Related Agencies will now proceed.
We welcome our distinguished colleague, Senator Rick
Santorum, who has demonstrated an ingenious approach to the
stem cell issue, leading to the introduction of legislation
denominated as S. 2754, which I have cosponsored, known as the
Santorum-Specter bill.
This subcommittee is now holding its 18th hearing on the
issue of stem cell research. When stem cell research was
broached back in November 1998, within 10 days this
subcommittee undertook its first hearing.
The legislation which we'll be considering today proceeds
with the innovative idea of having stem cell research without
dealing with the embryo, and it is one where people with
different views on underlying philosophical questions can come
together. As I have emphasized in the past, this does not mean
that I am abandoning my interest in embryonic stem cell
research, which Senator Harkin and I have been sponsoring for a
long while, which has been passed by the House of
Representatives, worth noting that some 50 Republicans joined
in passing that legislation.
We're operating under some time constraints today, or at
least I am, because the Judiciary Committee has a hearing which
has been deferred until 10 o'clock. But I think with the four
witnesses we have, we have a reasonably good chance of
concluding before 10 o'clock, and in the event we do not, I
will yield to Senator Harkin to finish up the hearing. Senator
Santorum has been invited to join the panel to question
witnesses on the second panel.
It is also worth noting that we had invited Dr. Edmund
Pellegrino, chairman of the President's Council on Bioethics,
to appear this morning, and he declined to come forward.
Senator Santorum is well known to us all, elected to the
House of Representatives in 1990, beat an entrenched incumbent
in Pittsburgh, going door-to-door; won an upset victory in
1994, and reelected in the year 2000; holds the number three
leadership position in the Republican Caucus; and is well known
for a wide body of legislative achievements, and we're hopeful
this will be the next in line.
Senator Santorum, we welcome you here, look forward to your
comments, and we'll not run the time clock on you.
statement of senator rick santorum
Senator Santorum. Thank you very much, Mr. Chairman.
Senator Harkin, thank you also for the opportunity to come here
and also the opportunity to stay and listen to the testimony.
I want to thank you, Mr. Chairman, for the extensive amount
of work that you have done, and that both of you have done on
this issue here in this subcommittee. I want to thank you also,
Mr. Chairman, for your willingness to work with me over the
past year in developing S. 2754, the Alternative Pluripotent
Stem Cell Therapies Enhancement Act, which you described in
your opening remarks I think aptly, which is a chance to try to
take people who are I think of good conscience and of goodwill,
who come out with a difference, on opposite sides of the issue
of the Specter-Harkin bill, but still believe that we need to
pursue scientific research, and do believe that pluripotent
cells offer some potential hope for therapies that could
enhance our health here in this country and advance medical
science here in this country.
We felt that there was a common ground to be able to find,
that we could develop pluripotent cells without the destruction
of the embryo, and we've worked together over the past year.
We've come forward with this piece of legislation, and I'm very
pleased that today you are inviting some very distinguished
witnesses to discuss this piece of legislation, and I am
looking forward to hearing from the scientists and from the
ethicists and having an opportunity to question them.
So I will keep my remarks brief, in that I delayed your
hearing. I apologize for that. But this whole effort came about
as a result of the President's Council on Bioethics white paper
that they issued, where they reviewed four techniques where
embryonic-like stem cells were derived without creating or
harming a human embryo. That sparked an interest I think in
many of us, that there may be a way for us to develop these
embryonic-like cells or pluripotent cells and avoid some of the
ethical problems that the President, myself, and many others
here in Washington and around the country have with respect to
embryonic stem cell research.
So I am excited that we are going to have this discussion.
I suspect that the legislation that we're discussing here
today, S. 2754, will be part of the debate here on the floor of
the U.S. Senate when we bring up the Specter-Harkin bill, that
this will be another piece of legislation that will be offered
with maybe one or two other bills.
I think it's an important discussion to have. It's not the
full step that you or Senator Harkin would like to see done,
and certainly a majority probably in the Senate, as well as you
mentioned a majority in the House would like, but I think it is
a very good, solid step in the direction of scientific
research. It opens up doors that may not have some of the
ethical concerns, moral concerns, that many have with the
original piece of legislation.
prepared statement
With that, Mr. Chairman, I'll conclude my remarks, and
thank you again for having this hearing. I would like if my
full statement could be made a part of the record.
Senator Specter. Without objection, your full statement
will be made a part of the record.
[The statement follows:]
Prepared Statement of Senator Rick Santorum
EXAMINING THE POTENTIAL IMPACT OF S. 2754, THE ALTERNATIVE PLURIPOTENT
STEM CELL THERAPIES ENHANCEMENT ACT
Mr. Chairman, I would like to thank you for holding this hearing on
this important legislation. I would especially like to thank you for
your assistance and work with me in drafting and introducing this
legislation. Your work on this is greatly appreciated.
This hearing is an opportunity to present some ideas in an area
where there has been a lot of heat and concern in recent years. There
has been a lot of division here in the United States Senate about the
ethical questions, the moral questions, and the scientific questions
related to embryonic stem cell research. People of good conscience have
lined up and have found themselves on the opposite sides of issues as
those that have traditionally been their allies. I have worked with
Senator Specter and several others to see if we can move forward in
this area of stem cell research, embryonic or pluripotent stem cell
research. We seek to move forward in a way that is both moral and
ethical by everyone's judgment while also making significant advances
from the scientific research perspective. This legislation is a
commonsense compromise that deserves wide support.
I am very pleased that you have invited the distinguished witnesses
that are here with us today. I am hopeful that when the issue of stem
cell research is taken up by the Senate, this legislation will be part
of the discussion.
While there will obviously be much discussion and debate on the
original proposal put forward by Senator Specter and Senator Hatch, we
should also discuss the alternatives, like this bill, that may be
acceptable not only here in the United States Senate, but also in the
House and very importantly, at the White House. That support is crucial
if such legislation is going to result in increased research and, most
importantly, in treatments for patients.
Last year, the President's Council on Bioethics issued a White
Paper reviewing four proposed techniques of deriving embryonic stem
cells without creating, harming, or destroying an embryo. Since this
report was issued, there have been other proposed techniques as well as
studies indicating that there may be alternative sources of these
valuable cells that have the potential to differentiate into all, or
almost all, of the cell types in the body.
I believe that by having pursued the direction taken by the
President's Council on Bioethics, we have written language that can
accelerate and focus research on areas that are both very promising
from a scientific point of view as well as acceptable from a moral and
ethical point of view.
I am hopeful that the benefits of this research will be seen in the
short term therapeutic use of pluripotent stem cells, as we see that
there are a number of companies that are pursuing therapies using stem
cells and trying to develop pluripotent cells for clinical treatment
and for commercial purposes. This research is also important in the
long term as we consider how to develop these pluripotent stem cells
for purposes of enhancing human knowledge as well as potentially
creating profound changes in our health as a world.
Clearly, the supporters of this bill, even the sponsors of the
bill, come at the stem cell issue from a variety of different
perspectives. I think it is important to note that not only does this
legislation focus resources in the area of ethical advancements of stem
cell research, but that there is also broad support across the
spectrum, short-term and long-term, for such a focus.
To close, I would like to provide a brief summary of the
Alternative Pluripotent Stem Cell Therapies Enhancement Act (S. 2754).
This bill is intended to intensify research into alternative ways of
deriving pluripotent stem cells. Study of these cells may lead to
improved understanding of or treatments for diseases. Recognizing the
ethical issues surrounding embryonic stem cell research and the
potential scientific advances that may alleviate these issues, S. 2754
seeks to promote the derivation of pluripotent stem cell lines from
alternative sources that do not require the creation of human embryos
for research purposes or discarding, destroying, or knowingly harming a
human embryo or fetus.
This bill would amend the Public Health Service Act to require NIH
to conduct and support basic and applied research to develop techniques
for the isolation, derivation, production, or testing of stem cells
that have pluripotent or embryonic-like qualities. Specifically, this
refers to stem cells that have the capability of producing all or
almost all of the cell types of the developing body and that may result
in improved understanding of or treatments for diseases and other
adverse health conditions. However, recognizing that there are real
ethical concerns with research requiring the destruction of a human
embryo and seeking to encourage research into alternative ways of
deriving these cells, the bill prohibits these funds from being used
for techniques or research that derives such cells from a human embryo.
To implement this research, the Secretary of HHS, in consultation
with the Director of NIH, will issue guidelines on research under this
provision. They will provide guidance concerning:
--The next steps required for additional research, including the
determination of the extent to which specific techniques may
require additional basic or animal research to ensure that any
research involving human cells is consistent with the purpose
of the bill.
--Prioritizing research with the greatest potential for near-term
clinical benefit.
--Taking into account the techniques outlined by the President's
Council on Bioethics and any other techniques and research.
This would include variations on altered nuclear transfer,
reprogramming of differentiated somatic cells, and other
techniques being used to isolate these pluripotent cells.
The bill authorizes for this research such sums as may be necessary
for fiscal years 2007 through 2009. S. 2754 requires a yearly report to
Congress on the activities being carried out and research being
conducted during the fiscal year.
In this bill, the term ``human embryo'' has the meaning given in
the applicable appropriations act. The applicable appropriations act is
defined as the appropriations act providing funding for HHS in the
fiscal year the research is conducted or supported. If there were no
definition in that year's appropriation act, then the applicable
appropriations act would be the act of the previous fiscal year.
Recognizing that supporters of the bill come from varying
perspectives on the legitimacy of embryonic stem cell research, S. 2754
contains a rule of construction saying that nothing in this bill shall
be construed to affect any policy, guideline, or regulation regarding
embryonic stem cell research, human cloning by somatic cell nuclear
transfer, or any other research not specifically authorized by this
section.
Again, the issue of embryonic stem cell research has been fraught
with strong passions and sharp disagreements. But this need not be the
case. A commitment to curing disease, promoting scientific progress and
respect for life are not mutually exclusive. Despite differing opinions
on whether taxpayer dollars should be used to support stem cell
research that is dependent on the destruction of a human embryo, there
is non-controversial common ground on this issue. This bill finds such
common ground.
Thank you again for holding this hearing.
Senator Specter. I'm here today with two of my partners,
and I didn't yield to Senator Harkin for his opening statement.
I was thinking about my Pennsylvania partner, not my committee
partner. It's nice to work with partners like Rick Santorum and
Tom Harkin.
Senator Harkin, I yield to you for an opening statement.
Senator Harkin. That's okay. I just ask that it be made a
part of the record.
[The statement follows:]
Prepared Statement of Senator Tom Harkin
No one in Congress has worked harder on the issue of stem cell
research than my chairman, Senator Specter.
He called the very first congressional hearing on stem cells back
in 1998, and this will be our 18th on this topic since then. And in the
past year, Senator Specter has led the effort to bring H.R. 810 up for
a vote in the Senate, so we can pass the bill and send it on to the
President.
So I hope he knows how much I admire everything he's done to
promote stem cell research.
I think he also knows my feelings about the bill we're discussing
today, S. 2754, and I hope he will accept my comments on it in the
spirit with which I offer them.
The best thing that can be said about this bill is that it does no
harm. It doesn't do any good, but it doesn't do any harm. Otherwise,
every activity that's authorized in this bill is something that NIH can
already do.
In other words, whether this bill becomes law or whether it fails
will have absolutely no impact on the progress of stem cell research.
There is one danger to this bill, however. Some opponents of
embryonic stem cell research want to use it as a decoy. They're trying
to convince people that they should oppose H.R. 810 and support this
bill instead.
That would be a tragic blunder. This bill touts the value of
alternative methods of deriving stem cells--not one of which has ever
been shown to work in humans. Some haven't even worked in animals.
Right now, they're just theories. Maybe one day, 10 years from now, one
of these methods will pan out. But maybe not.
Are these methods worth examining? Absolutely. I support any
ethical means to improve the lives of human beings who are suffering.
In fact, Senator Specter and I included language in our appropriations
bill last year urging NIH to support research on derivation methods
that don't involve the destruction of a human embryo.
But meanwhile, people we love are dying from Parkinson's and ALS.
Children are suffering from juvenile diabetes. People are losing the
ability to walk due to spinal cord injuries. They don't have 10 years
to wait and see if these alternative methods pan out. They need help
now.
That's why our focus needs to be on passing H.R. 810, not on this
bill.
Senator Harkin. I just want to say at the opening, I
welcome Senator Santorum here today and to this overall debate.
He should be here. Everyone should be here. This should be an
open, frank discussion, and I believe it has been.
Quite frankly I don't think anyone has worked harder on the
issue of stem cell research than Senator Arlen Specter. As he
said, he called the first hearing on this in 1998. As you said,
this is our 18th hearing that you have had, Mr. Chairman, on
this topic. Well, maybe I had a couple, I don't know, but there
are 18 that we've had on this. So I know that Senator Specter
knows how much I admire everything he has done on this issue.
I have looked at S. 2754, Senator Santorum, and would I be
opposed to it? Why would you be opposed to it? I'm not opposed
to it. I think the best thing that can be said about it, it
does no harm. I don't know that it does anything that isn't
already allowed to do, and I will ask Dr. Battey and others
about that. As a matter of fact, we have included report
language in our bill in the past that urged NIH to support
research on derivation methods that don't involve destruction
of a human embryo, so that's already there and they can do
that.
But the problem I have with the bill is that there are
some, I'm not saying Senator Santorum, but some who are
opponents of embryonic stem cell research that may want to use
this as a decoy, saying, ``Well, if you vote for this, then you
don't have to support H.R. 810. This is another way of getting
at stem cell research, rather than H.R. 810.'' So it's in that
context, Senator Santorum, that I would like to just engage
with you if I could, a little bit, on this.
It sounds, Senator Santorum, that we do agree that stem
cell research has a lot of potential for easing human suffering
and treating diseases. I think we may agree on that.
Senator Santorum. I think what I have said is that it's a
line of research that I think should be pursued. I'm not sure
at this point that we can make a statement that we know of any
necessarily known therapies, but that it's a line of research
that I think would be helpful to be pursued, and that's why I
support this act.
Senator Harkin. I think we may have testimony this morning,
I'm not certain, but I just read recently, Rick, about an
experiment at Johns Hopkins. Actually it has happened before,
but they had some mice that had spinal cord injuries, and they
had taken stem cells, and they had walked again. So this is
mice or rats----
Senator Santorum. Well, I know----
Senator Harkin [continuing]. As someone said, we're 99
percent rats. I don't know if they're talking about us as
politicians or not, but----
Senator Santorum. Speak for yourself on that one.
Senator Harkin. A generic term.
Senator Santorum. Yes, I understand.
Senator Harkin. I'm sure, then, we would also agree that we
need human stem cell lines to do the research. How many stem
cell lines have been created using altered nuclear transfer,
which is one of the proposed alternative methods that you're
promoting in your bill?
Senator Santorum. Again, I think the answer, to my
knowledge, is none. But my sense is that this is an area, at
least according to a lot of research that has come out, new
techniques, altered nuclear transfer is one of the techniques
mentioned in the President's report, one of the things that
would be funded specifically with this legislation.
But what we're seeing is almost, I won't say on a daily
basis but certainly at least once a month you're seeing some
new technique or some other derivation of pluripotent cells
being developed out there, either in the private sector or in
the research lab, and we think that this is a very promising
area to be explored. We want to make sure that the NIH has a
really comprehensive and holistic look at this, and in not just
report language but we express clear congressional intent that
this is an area that we'd like them to focus on.
Senator Harkin. So none from that, and how many human stem
cell lines have been created using blastomere extraction, which
is another of the proposed alternative methods?
Senator Santorum. Again, I'm not sure that any of the
techniques that have been described here are ones that have
produced any kind of stem cell lines to this point.
Senator Harkin. That's the point.
Senator Santorum. The point is that what we've seen in
research labs is that the potential exists, and in fact
testimony--we had a group of scientists in just 2 weeks ago,
you know, Dr. Gromke as well as Dr. Yenish, both of whom were
renowned scientists in the area of stem cell research, both
saying that they believe that these alternative techniques have
great promise and should be pursued.
So I'm not suggesting that we're there yet, but I think if
you would have had--I'm sure when Senator Specter and you had
your first hearing, there may not have been any of the advances
then that we're talking about now. It's early stages of
development of these techniques, and we'll wait and see whether
they'll be successful or not.
Senator Harkin. Well, I guess that's my point. Every other
proposed alternative method has produced no stem cells, stem
cell lines, but current methods have produced dozens. So my
point is, if scientists want to do research with human stem
cells, they would have two options. They could use stem cells
that are derived from current methods, or they can wait several
years for the possibility--and it's just a possibility--that
one of the alternative methods will pan out. So it seems to me
if you're really interested in promoting stem cell research, it
doesn't sound like much of a choice.
Senator Santorum. I would say, Senator, that some of the
people that have come forward and testified about other methods
to develop pluripotent cells have developed those pluripotent
cells--I don't know about what you call lines of cells, but
have developed pluripotent cells in commercial laboratories
using--we have a company in Pittsburgh that testified last
week, that takes cells from the lining of the placenta and has
been able to transform those cells into a variety of different
types of cells that they believe could be useful.
So it's not that cells have not been developed that could
potentially be useful. I think there are a lot of alternative
methods out there that have developed alternatives to develop
these types of, whether muscle cells, nerve cells.
Senator Harkin. Clearly my point, Senator. Clearly my
point. As I said, we have included language. People are looking
at these possibilities. I have no problem with that. My problem
is that you're going to stop the present embryonic stem cell
research using the kind of derivation of stem cell lines that
we know works. They have extracted those. They know they can
get the pluripotent cells out of these stem cell lines.
So my point is that, you know, we've got people suffering
from ALS and juvenile diabetes, and many of the scientists who
have testified before us many, many times have said that
perhaps the first thing that could be cured using stem cells,
embryonic stem cells, would be juvenile diabetes, because of
the nature of islet cells and that kind of thing. I don't
pretend to even understand all that, but that's what they tell
us. I may never.
So I'm just say that if all we're going to tell these
people is wait and wait, we're going to examine all these other
possibilities, but we're going to clamp down and we're not
going to use the kind of stem cell lines that we know can be
derived from embryonic stem cells, what kind of hope are you
giving these people? All you say is wait.
Senator Santorum. I would say, as the Senator knows, if we
really want to invest in getting something short term, you
would be doing a lot more investment in adult stem cells than
you would in embryonic stem cells.
Senator Harkin. They're doing that, too.
Senator Santorum. Again, I mean, that's the whole point.
You make this out to be it's a zero sum game. It's not. It's
not a zero sum game. The fact of the matter is that there's
research being done on a variety of different areas, and all
we're saying is this should be an additional area of research.
Senator Harkin. But I'm not the one, Senator, trying to
stop H.R. 810. You are.
Senator Santorum. Senator, I've been very clear about my
position on that issue. What we're trying to do here is, I
think----
Senator Harkin. I'm not trying to stop you.
Senator Santorum [continuing]. It's pretty clear, Senator,
that the chances----
Senator Harkin. To me it's zero sum.
Senator Santorum [continuing]. The chances of that
legislation, given a presidential veto, becoming law this year,
are not very good. So what I was suggesting is that, since that
does not look like a promising approach, that we can at least
begin to develop alternatives that may be promising in the
future.
Senator Harkin. Well, one of those alternatives that's
being talked about a lot is the altered nuclear transfer. Dr.
Hurlbut has testified before us. I've talked to him about it.
What you do is, you take normal human DNA, you knock out a
gene, you transfer it to a human egg, you create some new human
material that no one has ever seen before. It's preprogrammed
to die.
I'm surprised that, given your pro life stance on most
issues, you support the idea of creating some kind of
inherently defective human entity that's destined to die after
just a few days. What am I missing here?
Senator Santorum. Yes. You're missing that we're not
creating a human entity. What we're creating is tissue. We're
not creating any type of living organism that could ever be
human. So I think a lot of ethicists, bioethicists, have looked
at this. There is, I won't say a unanimous feeling, but as
broad a consensus as I've seen in the area of bioethics that we
are not creating a defective embryo. We are creating something
that could not be human, that is not anything but tissue.
Senator Harkin. Help me explain this. You have a human egg.
The DNA inside the egg is human, so you have a human egg, human
DNA. So it's not a pig, it's not a rock. What is it? You've got
two human things: human DNA, human egg. What is it?
Senator Santorum. My understanding is--and probably the
scientists will do a little better job at explaining this than
I do. I'm not a bioethicist, nor am I a biologist. The reading
that I've done and the testimony that I've received from those
who are experts, the consensus was that we are not creating an
embryo. I am satisfied that, given the testimony that I've
received near unanimously, that this is not a human embryo.
Senator Harkin. Well, I've heard others describe it as a
human embryo preprogrammed to die, a defective, an inherently
human created defective embryo preprogrammed to die. Because it
is an embryo. It's DNA, it's human DNA, it's a human egg.
Senator Santorum. I would suggest, Senator, that if that
were the case, then I would not be supporting it, the Catholic
Conference wouldn't be supporting it, the National Right to
Life wouldn't be supporting it, and every other organization
that opposes embryonic stem cell research wouldn't be
supporting this if that's in fact technically what was going
on.
Senator Harkin. Well, I would quote perhaps one of your
favorite columnists--perhaps, I don't know--Charles
Krauthammer, who is a member of the President's Council on
Bioethics. He described this proposal as being ``repugnant''
and ``weird.'' I quote him as saying, ``It's an aborted attempt
to produce a human. It's an attempt to produce a human that
went wrong.'' So that's one member of the President's Bioethics
Council----
Senator Santorum. You know, there's a variety of opinions
out there. I can tell you what the consensus of opinion is, and
I'm comfortable with that. Again, that's only one type of
research that's being funded under this legislation. That would
be one, and probably one of the more speculative ones at that.
Senator Harkin. Now, I just want to make sure that I heard
you correctly. You said the U.S. Catholic Conference supports
altered nuclear transfer and says it's ethical?
Senator Santorum. My understanding is that they have taken
a position in support of this legislation, and since----
Senator Harkin. I'm not talking about the legislation. I'm
talking about altered nuclear transfer.
Senator Santorum. I can't imagine--the answer is that they
support the legislation that calls for the funding of that, and
so I would suspect that they would not have any moral
objections to it.
Dr. Yenish, who testified last week, who has done research
in this area, said that this is not an embryo. In fact, all the
scientists last week that came forward said that this is not an
embryo, and as you know from the legislation, this only
approves studies in animals, not humans, in order to determine,
first, to make sure that we are not creating an embryo.
Senator Harkin. We got a letter from Dr. Yenish, from the
Whitehead Institute, said that he had participated in a recent
press conference sponsored by Senator Rick Santorum on his
bill, S. 2754. He said, ``I'd like to take a moment to clarify
my position on his bill and on this complex issue.'' He said,
``S. 2754 should not be viewed as an alternative to pending
legislation.'' Then at the bottom he said, ``I strongly back
H.R. 810.''
Senator Santorum. He made that clear in the--
Senator Harkin. Ok. I just want to make sure that the
record shows that. What I have said about your bill, I don't
mind this bill. It's fine. I'm just saying I don't know what it
does that they can't already do, and the point I'm trying to
make is that with H.R. 810, and you might say, ``Well, the
President will veto it,'' I don't know if he will or not.
Senator Santorum. He has made it pretty clear that he will.
Senator Harkin. I don't know. He doesn't have it in front
of him. I think our job is to do what we can to promote good
scientific research and to do it in an ethical manner, which I
believe H.R. 810 does, and to get it to the President.
I know our time is short. I don't want to take any more
time. I just have one other question I want cleared up for me
and for the record, and I just want to understand this: Senator
Santorum, do you support in vitro fertilization?
Senator Santorum. Do I support in vitro fertilization, as
far as whether it should be legal or not, or would I personally
do it?
Senator Harkin. No. First, should it be legal?
Senator Santorum. It is legal. I would personally not do
it. That's not something that--according to the Catholic faith
that I subscribe to, it is against it, and so personally I
would not do it, but I would not vote for any law that would
outlaw it.
Senator Harkin. So it's okay if others use in vitro
fertilization?
Senator Santorum. As you know, it is permissible. I have
said I do have concerns about the lack of regulation over in
vitro fertilization clinics, and have expressed concerns about
that, particularly the number of embryos that are created at a
time. I think that's a concern of mine, and I have publicly
expressed concern about that, but I have not--I would certainly
allow, not vote for any law that would ban in vitro
fertilization.
Senator Harkin. Or restrict it?
Senator Santorum. Well, again, my concerns, I do have
concerns about the number of embryos created in certain
circumstances in in-vitro clinics, and so when you say ``not
restrict it,'' it would depend. I have very serious concern,
particularly now that we're getting into potentially embryonic
stem cells, that we would be creating a large number of embryos
that would never have a chance of being implanted, and so I do
have concerns about that.
Senator Harkin. I think H.R. 810 just speaks about the
embryos that have already been created, which are about
400,000.
Senator Santorum. I understand that, but that's now. I
mean, there's always the future, and I have concerns about
that.
Senator Harkin. Well, it just seems to me we may have a
difference on this. It just seems that if in vitro
fertilization is legal and you say it's fine and you wouldn't
end it, you would let it go, and we have all these leftover
embryos that are frozen, that can be used to derive stem cells
that scientists tell us can be used to help cure some very
serious illnesses, I don't know what you do with 400,000
embryos. I mean, they're being discarded every day, right now.
I mean, you look upon this as morally repugnant, but it
seems to me that the best use would be to say if you can use
these to help sustain life and to ease suffering and pain, that
that would be the morally right thing to do, rather than to
have them discarded. That seems to me to be what H.R. 810 is
trying to do.
Senator Santorum. I understand that, and as I said in my
opening remarks, I think people of good conscience can be on
both sides of this issue. I happen to believe that that is not
the better moral choice; that the better moral choice would be
to let that individual, and the embryo is an individual, it's
human life, to die with dignity as opposed to being used for
research purposes without their consent. That's the moral
choice that I have made. I disagree with you. You disagree with
me. I respect your opinion.
Senator Harkin. It seems to me than an embryo, to die with
dignity, getting flushed down a toilet like they do now is not
dignity. But to extract stem cell lines and to use it to
promote and enhance life, to me is dying with dignity.
Senator Santorum. We disagree.
Senator Harkin. That's our difference.
Senator Santorum. Thank you.
Senator Specter. Thank you very much, Senator Harkin.
Thank you, Senator Santorum.
We now turn to our second panel. I renew the invitation to
Senator Santorum to join us on the panel. Our first witness is
Dr. James Battey, Chairman of the NIH Stem Cell Task Force,
Director of the National Institute on Deafness and Other
Communication Disorders at NIH. Bachelor of Science from
California Institute of Technology, and M.D. and Ph.D. degrees
from Stanford.
Thank you for joining us again today, Dr. Battey. As you
know, our practice is to have 5-minute rounds. We want to
invite Dr. Alan Leshner and Dr. Stephen Strom to join us on the
panel at this time, and the floor is yours, Dr. Battey, for 5
minutes.
STATEMENT OF JAMES F. BATTEY, JR., M.D., Ph.D.,
DIRECTOR, NATIONAL INSTITUTE ON DEAFNESS
AND OTHER COMMUNICATION DISORDERS, AND
CHAIR, NIH STEM CELL TASK FORCE, NATIONAL
INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH
AND HUMAN SERVICES
Dr. Battey. Mr. Chairman, Senator Harkin, and other
distinguished members of the subcommittee, I am delighted to
have an opportunity to again testify about stem cell research.
I've had an opportunity on several other occasions to do so,
and I'm sure you are aware that I believe human embryonic stem
cells are an important tool for advancing our knowledge about
cell specialization, and it has great potential to ultimately
be medically valuable and beneficial.
However, as I'm sure the last 25 minutes have highlighted,
there are differences of opinion about the moral and ethical
wisdom of destroying human embryos for the purpose of creating
pluripotent cells. There have been recent publications
describing potentially alternative ways to establish human
pluripotent stem cells that claim to avoid the contentious
issue of creating, destroying, or harming human embryos, and
I'm going to try to quickly outline a little bit about the
science and what the state of the science is in this area.
So I'm going to begin by talking about pluripotent stem
cells from nonviable embryos. Scientists proposing this method
noted that during human in vitro fertilization or IVF, that
there are numerous embryos that fail to continue to divide and
are judged to be unsuitable for implantation.
They argue that these nondividing entities are dead, and
they propose that harvesting cells from these embryos for the
purpose of creating a human embryonic stem cell line is no
different than organ donation by a person judged to be brain
dead. They argue that this approach is morally acceptable.
Recently these same scientists published a paper where they
evaluated the physical characteristics of human embryos created
for IVF but not used because they were considered to be
nonviable.
They observed that some of the nonviable embryos had fewer
cells than would be expected otherwise, and that they failed to
compact and clump together into a structure called a morula,
which is typically during normal human development what is
happening around 4 days postfertilization, or a blastocyst,
which is the structure that we typically have 5 days after
fertilization. They proposed that these nonviable embryos with
these features of arrested development at 5 days
postfertilization be considered dead, and might serve as an
acceptable source of nonviable human embryos in an attempt to
generate human embryonic stem cell lines.
From a scientific perspective, there is no published study
showing that it is possible to generate an embryonic stem cell
line from a nondividing embryo fulfilling these criteria, in
rodents, nonhuman primates, or humans. If stem cell lines could
be derived from such embryos, the resulting cell line would
have to be carefully monitored for genetic abnormalities or
other defects which could be the underlying cause of the
embryo's failure to develop in the first place.
Finally, the human embryo research ban to the Department of
Health and Human Services appropriation act prohibits the use
of funds appropriated to DHHS to support the creation of a
human embryo for research purposes, or research in which a
human embryo is destroyed, discarded, or subjected to risk of
injury or death greater than that allowed under Federal
requirements for fetuses in utero. Applicability of this
prohibition would have to be analyzed before NIH could fund
research on this technique using human embryos.
Now I would like to turn to pluripotent stem cells from
biopsied blastomeres. This proposal involves creating an
embryonic stem cell line by removing a cell from an embryo at
the eight-cell stage, which is typically 3 days
postfertilization in an IVF clinic, and it's referred to as
single cell embryo biopsy.
A similar procedure is already in use for preimplantation
genetic diagnosis, where a single cell is removed from an
eight-cell stage embryo for genetic analysis. The remaining
seven cells, constituting the embryo, are used for reproductive
purposes through the standard IVF procedure, if the genetic
analysis of that single cell shows the embryo to be genetically
healthy.
The proponents of this proposal suggest that the success of
preimplantation genetic diagnosis is proof of principle that
removal of a single cell does not frequently damage the
remaining embryo. Using this premise, this proposal argues that
a single cell or several cells may be removed from an embryo at
the eight-cell stage at the same time the embryo is undergoing
preimplantation genetic diagnosis, and that these additional
cells could be used for the purpose of creating a human
embryonic stem cell line.
The proposal further argues that if one limits this
approach to embryos undergoing preimplantation genetic
diagnosis, one is not compromising any embryos that are not
already being compromised, and is assured that embryos that are
being used for this purpose were created for reproductive
purposes and not solely for research purposes.
Recently, privately funded scientists attempted to
establish a mouse embryonic stem cell line using this
procedure, single cell embryo biopsy. After harvesting a single
cell, and attempts to establish a mouse ES cell line, the
remaining cells of the embryo were implanted in surrogate mouse
wombs, and approximately half of these embryos developed into
seemingly normal mouse pups, and that's about the same
percentage as in the control group where the embryos were not
biopsied.
So this research is the first to demonstrate that single
cell embryo biopsy can be used successfully to generate stem
cell lines in a mouse model organism. If the technique succeeds
with human embryos, it may provide another way to generate
human embryonic stem cell lines.
But it's important to note that scientists do not yet know
how much risk the procedure actually might confer to an
otherwise healthy human embryo. Additionally, these experiments
do not address the concern that the very early cell that is
biopsied and used for PGD may in itself be capable of
developing into a living human being, and if this were true,
destruction of the single cell may----
Senator Specter. Dr. Battey, how much longer would you need
for your statement?
Dr. Battey. I can cut right to the end and just take your
questions.
Senator Specter. Would you please do that?
Dr. Battey. I will do that, and I'm sorry that I've gone
over my time.
Senator Specter. That's okay.
PREPARED STATEMENT
Dr. Battey. We welcome the receipt of investigator-
initiated research grant applications whose goal is to generate
pluripotent cells using technology that does not require the
use of potentially viable embryos, so long as this research is
not judged to be ineligible for Federal funding because of the
human embryo research ban.
Senator Specter. Thank you very much, Dr. Battey.
[The statement follows:]
Prepared Statement of Dr. James F. Battey
Mr. Chairman, Senator Harkin, and Members of the Subcommittee, I am
pleased to appear before you today to testify about stem cell research.
As you are aware, I previously testified to this Subcommittee about
human embryonic stem cells (hESC) as a tool for advancing our knowledge
about cell specialization, and its great potential to be medically
valuable. However, using established methods, these cannot be obtained
without destroying human embryos. There have been recent publications
about alternative ways to establish human pluripotent stem cell lines
that claim to avoid the issue of creating, destroying, or harming human
embryos. In 2005, the President's Council on Bioethics published a
white paper on ``Alternative Sources of Human Pluripotent Stem Cells.''
My testimony will provide some information on the scientific advances
highlighted in that report.
PLURIPOTENT STEM CELLS FROM NONVIABLE EMBRYOS
Scientists proposing this method noted that during the human in
vitro fertilization (IVF) process, there are numerous embryos that fail
to continue to divide and are therefore judged to be unsuitable for
implantation.
Recently, in a privately funded study, the scientists evaluated the
physical characteristics of human embryos created for IVF but not used
because they were considered to be ``nonviable.'' The scientists
observed that many of the nonviable embryos had fewer cells than
normal, and failed to compact into a morula or a blastocyst, which are
developmental stages of the embryo. They propose that nonviable embryos
with these features of arrested development at 5 days post-
feritilization be considered ``dead.'' This would allow scientists to
harvest cells from nonviable human embryos in experimental efforts to
generate human embryonic stem cell lines. (Regen. Med. 1: 367-371, D.W.
Landry, H.A. Zucker, M.V. Sauer, M. Reznik, L. Wiebe).
To date, there is no published study showing that it is possible to
generate an embryonic stem cell line from a non-dividing embryo in
rodents, non-human primates, or humans. If stem cell lines could be
derived from such embryos, the resulting cell line would have to be
carefully monitored for karyotypic (genetic) abnormalities or other
defects.
PLURIPOTENT STEM CELLS FROM BIOPSIED BLASTOMERES
This proposal involves creating an embryonic stem cell line by
using a blastomere cell from an embryo. When performing pre-
implantation genetic diagnosis (PGD), a single blastomere cell is
removed from an 8-cell stage embryo (approximately day 3 in embryo
development where all cells are assumed to be totipotent) for genetic
analysis, and the remaining seven cells constituting the embryo are
used for reproductive purposes through the standard IVF procedure. The
proposal states that a single cell, or several cells, might be removed
from an embryo at the 8-cell stage at the same time the embryo is
undergoing PGD, and these additional cell(s) could be used for the
purpose of creating a hESC line.
Recently, privately funded scientists removed (i.e., biopsied)
single cells from early mouse embryos and used them to establish mouse
embryonic stem cell lines. The remaining cells of the embryo were
implanted in surrogate mouse wombs, and approximately half developed
into seemingly normal mouse pups. In the control group of embryos that
did not undergo biopsies, about half also developed to birth as normal
pups. This research is the first to demonstrate that single cell embryo
biopsy can be used successfully to generate stem cell lines. If this
technique succeeds with human embryos, it may provide another way to
generate human embryonic stem cell lines. Although single cell embryo
biopsy proposes to avoid embryo destruction, scientists do not yet know
how much risk the procedure might confer to an otherwise healthy human
embryo. (Nature 439:216-219, laboratory of R. Lanza)
NIH believes that such experiments could and should be pursued in
non-human primates. If this approach is successful, the resulting stem
cell lines would, of course, have to be validated for genetic
stability, pluripotency, and unlimited self-renewal--all cardinal
features of embryonic stem cell lines generated from blastocysts by
culturing the inner cell mass.
PLURIPOTENT STEM CELLS FROM BIOLOGICAL ARTIFACTS
Proponents of this method assert that it may be possible to do the
following: (1) genetically modify a somatic cell in culture, for
instance, the cell might be engineered to lack a gene or genes crucial
for cell-to-cell signaling or the integrated organization essential for
normal embryogenesis; (2) use this genetically modified somatic cell as
the source of a nucleus and genome for somatic cell nuclear transfer
(SCNT) into a human oocyte. This method is referred to as Altered
Nuclear Transfer (ANT); (3) allow the resulting entity to develop to a
point when it may yield embryonic-like stem cells; and (4) after
extraction, attempt to generate a hESC or hESC-like line from these
cells.
ANT is a general concept that its proponents suggest could take a
number of specific forms. One version of the idea proposes that
scientists turn off a gene needed for implantation in the uterus (Cdx2)
in the patient cell nucleus before it is transferred into the donor
egg. NIH-supported scientists recently reported proof of principle
tests that ANT works in mice. Mouse ANT entities whose Cdx2 gene is
switched off are unable to implant in the uterus and do not survive to
birth. However, scientists used ANT to create viable stem cell lines
capable of producing almost all cell types. The scientists point out
that this technique must still be tested with monkey and human donor
nuclei, and the manipulation needed to control Cdx2 expression
introduces another logistical hurdle that may complicate ANT's use to
derive embryonic stem cells. (Nature 439(7073):212-5, laboratory of R.
Jaenisch)
PLURIPOTENT STEM CELLS BY REPROGRAMMING SOMATIC CELLS
This proposal involves reprogramming human somatic cells, perhaps
with the aid of special cytoplasmic factors obtained from oocytes (or
from pluripotent embryonic stem cells), so as to ``dedifferentiate''
them back into pluripotent stem cells. Crucial to this approach is
discovering a way to reverse cell differentiation all the way back to
pluripotency, but not further back to totipotency.
Scientists in Germany recently succeeded in coaxing adult mouse
stem cells that normally produce sperm (spermatogonial stem cells, or
SSCs) to instead behave in a manner similar to embryonic stem cells.
They accomplished this switch of fate by finding the elusive SSCs in
mouse testicles and growing them in the laboratory under standard
embryonic stem cell culture conditions. Under those conditions, the
cells made several proteins characteristic of embryonic stem cells. The
scientists subjected the cells to critical tests for pluripotency, and
their results suggest that the cells can become any type of cell in the
body. As a result, the scientists named them multipotent adult germline
stem cells (maGSCs). If scientists can find similar cells in human
testicles, the cells could provide a new source of patient-specific
stem cells, and could also provide more pluripotent cell lines for
research. (Nature advance online publication, laboratory of G.
Hasenfuss)
In another study, privately funded scientists fused cultured adult
human skin cells with hESCs. The resulting ``hybrid'' cells had many
characteristics of hESCs--they grew and divided in a similar manner and
manufactured proteins that are typically made in hESCs. Some as-yet
unknown factor(s) within the hESCs enabled them to ``reprogram'' the
adult skin cells to behave as hESCs. The cells still raise a
significant technical barrier that must be overcome before they can be
used to treat patients. Because fused cells are tetraploid (i.e., they
contain four copies of the cellular DNA rather than the normal two
copies), scientists must develop a method to remove the extra DNA
without eliminating their hESC-like properties. If this hurdle can be
overcome, this technique may one day allow scientists to create
patient-specific stem cells without using human eggs. At present, this
new approach to creating stem cells is a useful model system for
studying how stem cells ``reprogram'' adult cells to have properties of
pluripotent cells. (Science 309:1369-1373, laboratory of K. Eggan)
Privately funded scientists in the United Kingdom now report that
the reprogramming process in mice is more efficient when they engineer
the stem cells to over-express Nanog, a gene important for maintaining
stem cells' self-renewing properties. The scientists reported a 200-
fold increase in the efficiency of the process when mouse embryonic
stem cells that over-expressed Nanog were fused with stem cells from
mouse brain; however, the fused cells are tetraploid. This study
demonstrates that Nanog plays an important role in reprogramming the
mouse brain cells to a state of pluripotency. If these results can be
repeated with human cells, they would represent a first step toward
learning how to reprogram adult cells to behave as stem cells and
directing them to become specific cell types for use in treating human
beings. (Nature Advance Online Publication 14 June 2006; lab of A.
Smith)
CONCLUSION
NIH welcomes the receipt of investigator-initiated grant
applications on these research topics. As with all grant applications,
such proposals would be judged for scientific merit by peer review. We
are very grateful for your continued support. I will be happy to try to
answer any questions that you might have.
STATEMENT OF ALAN I. LESHNER, Ph.D., CHIEF EXECUTIVE
OFFICER, AMERICAN ASSOCIATION FOR THE
ADVANCEMENT OF SCIENCE
Senator Specter. Our next witness is Dr. Alan Leshner,
chief executive officer of the American Association for the
Advancement of Science and executive publisher of the Science
magazine. Prior to joining the association, Dr. Leshner was
Director of the National Institute on Drug Abuse at NIH.
Undergraduate degree from Franklin Marshall, Master of Science
and Ph.D. from Rutgers.
Thank you for coming in today, Dr. Leshner, and the floor
is yours.
Dr. Leshner. Thank you very much, Senators. I'm delighted
to be here to testify on behalf of AAAS, which is the world's
largest multiple-discipline scientific society, and as you
said, publisher of the journal Science. AAAS was founded in
1848, and includes some 262 affiliated societies that, in the
aggregate, represent roughly 10 million individuals around the
world.
Let me start by saying that we loudly applaud your efforts,
Senators, in holding this hearing today and in your other
significant work on the issue of stem cell research and its
tremendous clinical promise. We believe that the great clinical
promise in stem cells makes it critically important to support
research on a wide range of approaches toward deriving cells
that have the potential for replacing damaged or deteriorating
parts of the body.
I can say that since the breakthrough in human embryonic
stem cell research in 1998, an overwhelming majority of the
scientific community and as well a significant proportion of
the American people have held the position that only through
Federal support of research on both adult and embryonic stem
cells can we understand fully the potential value and the
limitations of stem cells as an eventual clinical application
for a wide variety of illnesses.
The AAAS board of directors formalized its position in 2002
with a resolution that strongly endorsed embryonic stem cell
research techniques, including nuclear transplantation, and
called for a ban on reproductive cloning. At the same time our
board emphasized this research should only proceed if it's
guided by clear ethical guidelines.
In that regard, in 2005 the National Academies issued its
guidelines for human embryonic stem cell research. These
guidelines were prepared to enhance the integrity of human
embryonic stem cell research by encouraging responsible
practices and they address the wide array of ethical, legal,
scientific, and policy issues.
As the bill under discussion makes clear, we're now seeing
a variety of new techniques that appear to hold some potential
as additional routes for deriving stem cells. We at AAAS
encourage research into these approaches, although they are
still in very early stages of development, as you have heard
this morning.
The alternatives that are now being developed are in fact
intriguing, but we really don't know what their ultimate
utility will be, and each has potential problems or
complications that will require a great deal more research
before we know what their viability might be. This entire field
is still very young, and at the moment we believe the most
promising method appears to be the derivation of embryonic stem
cells, either through somatic cell nuclear transfer or from
excess embryos from in vitro fertilization clinics.
As you mentioned before, as just one example, within the
past 2 weeks Johns Hopkins University revealed that a team of
researchers had utilized injections of embryonic stem cells
into rat spinal cords to rewire part of their nervous systems
and restore muscle function, the ability to walk.
I do want to mention that the embryonic stem cell issue has
more than just clinical implications. Many of the countries
with whom we cooperate and compete, both scientifically and
economically, are intensively pursuing human embryonic stem
cell research. Countries like Great Britain, Singapore, South
Korea, Israel, those in Scandinavia, have very advanced
programs in human embryonic stem cell research.
On June 15 the European Union parliament in effect approved
funding human embryonic stem cell research as part of their
Framework 7 research program. Several prominent U.S. scientists
have already taken their research abroad.
Moreover, many States in this country, impatient with
current Federal policies, have developed their own research
support mechanisms so that their scientists will not be left
behind competitors in other countries. This will better enable
those States to reap the eventual benefits of locally conducted
human embryonic stem cell research.
PREPARED STATEMENT
In closing, I want to congratulate you again for shining a
bright light on this field of stem cell research that has such
tremendous potential health and economic benefits for the
people of this country, and I hope that we will do all we can
to ensure that the full range of approaches are studied to
their scientific and ethical limits. Thank you.
Senator Specter. Thank you very much, Dr. Leshner.
[The statement follows:]
Prepared Statement of Dr. Alan I. Leshner
I am very pleased to appear before you on behalf of the American
Association for the Advancement of Science (AAAS), the world's largest
multiple discipline scientific society and publisher of the journal,
Science (www.sciencemag.org). AAAS was founded in 1848, and includes
some 262 affiliated societies and academies of science, representing
roughly 10 million individuals.
We applaud both your efforts, Senator Specter and Senator Santorum,
in holding this hearing today. We hope it will draw more attention to
the importance of research focused on developing and making use of stem
cells derived in a variety of ways. We believe that the great clinical
promise in stem cells makes it critically important to support research
on a wide range of approaches toward deriving cells that have the
potential for replacing damaged or deteriorating parts of the body.
Since the breakthrough in human embryonic stem cell research in
1998, a large majority of the scientific community, and, I might add, a
significant proportion of the American people, have held the position
that only through federal support of research on both adult and
embryonic stem cells can we understand fully the potential value and
limitations of stem cells as an eventual clinical application for a
wide variety of illnesses. The AAAS Board formalized its position in a
2002 resolution that strongly endorsed embryonic stem cell research,
including nuclear transplantation techniques, and called for a ban on
reproductive cloning. At the same time, the Board emphasized that this
research should only proceed if it is guided by clear ethical
guidelines that protect patients and build public confidence. In 2005,
the National Academies issued its Guidelines for Human Embryonic Stem
Cell Research. These guidelines were prepared to enhance the integrity
of human embryonic stem cell research by encouraging responsible
practices in the conduct of that research. They address the many
ethical, legal, scientific, and policy issues that concern both
scientists and the public.
As S. 2754 makes clear, we are now seeing a variety of new
techniques that appear to hold potential as additional routes for
deriving stem cells. We support research into these approaches,
although they are still in early stages of development. The
alternatives that are now being developed are intriguing, but we really
do not know what their ultimate utility will be. Moreover, as these new
techniques are being explored, and they should be, ethical questions
will arise. This reinforces our belief that public research policies
should not be driven by any single approach.
The entire field is still very young, and at the moment the most
promising method appears to be the derivation of embryonic stem cells,
either through somatic cell nuclear transfer or from excess embryos
from in-vitro fertilization clinics. As just one example, within the
past 2 weeks, the Johns Hopkins University revealed that a team of
researchers, with the support of NIH and the Muscular Dystrophy
Association, had utilized injections of embryonic stem cells into rats
to rewire part of their nervous systems and restore muscle function and
the ability to walk.
The embryonic stem cell issue has more than just clinical
implications. Many of the countries with whom we cooperate and compete,
both scientifically and economically, are intensively pursuing human
embryonic stem cell research. Countries like Great Britain, Singapore,
South Korea, Israel, and those in Scandinavia have very advanced
programs in human embryonic stem cell research. On June 15, the
European Union Parliament in effect approved funding human embryonic
stem cell research as a part of their Framework 7 research program.
Several prominent U.S. scientists have already taken their research
abroad.
Moreover, many states in this county, impatient with current
Federal policies, have developed their own research support mechanisms
so that their scientists will not be left behind competitors in other
countries. This will better enable those states to reap the eventual
benefits of locally conducted human embryonic stem cell research.
In closing, I want to congratulate you again for shining a bright
light on this field of stem cell research that has such tremendous
potential health and economic benefits for the people of this country.
I hope we will do all we can to ensure that the full range of
approaches are studied to their scientific and ethical limits.
STATEMENT OF STEPHEN STROM, Ph.D., PROFESSOR,
DEPARTMENT OF PATHOLOGY, UNIVERSITY OF
PITTSBURGH
Senator Specter. Our final witness on the panel is Dr.
Stephen Strom, professor at the University of Pittsburgh.
Undergraduate degree from Westmore College in Lamar, Iowa, so
that he's a twofer, both Iowa and Pennsylvania. We don't often
get that. We thank you, Dr. Strom. Ph.D. at the University of
Kansas Medical Center. Pardon me, you're a threefer, because my
home State is Kansas.
Do you have anything else to recommend you, Dr. Strom,
before we turn to you? Thank you for being with us and for
representing Pennsylvania, Iowa, and Kansas. The floor is
yours.
Dr. Strom. Good morning, Senator Specter. Senator Harkin,
it's a pleasure to meet you, as well, and Senator Santorum.
Thank you for inviting me to talk about our research today.
Our laboratory has been involved in the area of
regenerative medicine for over 15 years. We believe that many
liver diseases can be treated by transplantation of isolated
liver cells, not just by organ transplant alone, but actually
by transplantation of isolated liver cells into these patients.
Our group was the first in the United States to treat liver
failure and metabolic liver disease by the transplantation of
isolated hepatocytes. We have actually transplanted about 25
patients to date, and the results, although still experimental,
are quite promising, so this regenerative medicine approach
actually works.
Just as with whole organ transplants, there is a problem
with the cell source, so a number of years ago we became
somewhat reluctant stem cell biologists. We tried to generate
liver cells for these transplant procedures through different
mechanisms from stem cells.
Again, for a number of reasons we decided to focus on the
placenta as a possible stem cell source. We began to look for
cells that had characteristics of embryonic stem cells, and we
were surprised and clearly gratified to find that there's a
number of stem cell characteristics that can be found on the
amniotic epithelial cells.
So late in November of last year we reported that the
amniotic epithelial cells isolated from human term placentas
expressed the surface markers normally present on embryonic
stem cells, including the stage specific embryonic antigens and
the tumor rejection antigens. In addition, they expressed the
genes that are thought to be the molecular basis of
pluripotency, including nanog and Oct-4.
Based on immunological data, we were able to demonstrate
that these cells can differentiate to all three germ layers in
a culture dish, and that includes endodermal differentiation
such as liver and pancreas, mesodermal differentiation such as
cardiomyocytes, and ectodermal differentiation into neural
cells such as neurons and neuroglia. Under specific conditions,
we can even get some self-renewal of these stem cells.
We believe this stem cell source from human amnion has
several characteristics which will be very useful for
transplantation and regenerative medicine. First of all, these
cells appear to be pluripotent, and they can form all the cell
types of the body. The amnion does not require feeder layers,
so they could be grown without exogenous feeder layers and the
problems associated with that.
The amnion-derived stem cells do not form tumors when
transplanted into animals, and they have even been transplanted
into humans already in other types of research, and they are
not tumorigenic in humans.
The amnion is freely available, and it is discarded, it is
normally thrown away after a live birth of a baby, so therefore
it's almost like throwing the baby out with the bath water. We
believe we're throwing away stem cells every day, when we could
be saving these.
Amnion is certainly abundantly available in the United
States. With over 4 million live births, there's going to be a
number of HLA phenotypes that are available to actually match
virtually every patient that would need a transplant in the
United States. Amnion-derived stem cells are obtained from a
term placenta, and this is only available to us after a live
birth of a baby, so thus we believe that there will be no
social, ethical, or religious opposition to the use of this
stem cell source.
PREPARED STATEMENT
I would like to conclude from our initial studies that
these cells may be a very useful stem cell source for
transplantation and regenerative medicine, and we urge support
from the Congress on this promising area. Thank you.
Senator Specter. Thank you very much, Dr. Strom.
[The statement follows:]
Prepared Statement of Dr. Stephen Strom
STEM CELL CHARACTERISTICS OF AMNIOTIC EPITHELIAL CELLS
Good morning, Senator Specter and other Members of the Senate
Labor/Health and Human Services/Education and Related Agencies
Appropriations Subcommittee. My name is Dr. Stephen Strom, and I am a
professor in the Department of Pathology in the School of Medicine at
the University of Pittsburgh. I am also affiliated with the McGowan
Institute for Regenerative Medicine at the University of Pittsburgh. I
am pleased to have the opportunity this morning to provide testimony on
my research on amniotic epithelial cells, as a scientifically
appropriate and non-controversial alternative to embryonic stem cells
for cell transplantation and regenerative medicine.
Our laboratory has been active in the area of regenerative medicine
for nearly 15 years. We believe that some liver diseases currently
treated by whole organ transplantation might be corrected, by the
transplantation of isolated liver cells in a procedure which is simple,
safe, less invasive and less costly than whole organ transplantation.
We were the first group in the United States to treat liver failure and
metabolic liver disease by the transplantation of isolated liver cells.
So far our group has treated approximately 25 patients with this
cellular therapy. While still experimental, the results suggest that
liver cell transplants can support life in patients with terminal liver
failure and correct metabolic diseases of the liver.\1\
---------------------------------------------------------------------------
\1\ Strom et al., Hepatocyte Transplantation: Clinical experience
and potential for future use. Cell Transplantation 15 (Supplement 1)
S105-110, 2006.
---------------------------------------------------------------------------
Just as with whole organ transplants, there is a shortage of donor
livers for liver cell isolation. Approximately 3 years ago we became
somewhat reluctant stem cell biologists and decided to try to generate
liver cells for our transplants from stem cells. For a number of
reasons we decided to focus on the amnion layer of the placenta as a
possible stem cell source. We began to search for cells with
characteristics similar to those reported for embryonic stem cells. The
results were clear, the amnion of human placenta contains cells with
cell surface markers and a gene expression profile which is very
similar to those found on embryonic stem cells.
Last November in the journal Stem Cells, we reported that amniotic
epithelial (AE) \2\ cells isolated from human term placenta express
surface markers normally present on embryonic stem and germ cells
including stage specific embryonic antigens (SSEA) 3 and 4 and Tumor
rejection antigens (TRA) 1-60, 1-81. Like embryonic stem cells,
amniotic epithelial cells express the genes thought to be the basis of
pluripotency including the expression of octamer-binding protein 4
(Oct-4), and nanog. Based on immunohistochemical and genetic analysis,
we were able to demonstrate that in a culture dish, amniotic epithelial
cells have the potential to differentiate to all three germ layers--
endoderm (liver, pancreas), mesoderm (cardiomyocyte), and ectoderm
(neural cells). Under specific culture conditions, amniotic epithelial
cells display the capacity for self renewal.
---------------------------------------------------------------------------
\2\ Miki, et al., Stem Cell Characteristics of amniotic epithelial
cells. Stem Cells 23: 1549-1559, 2005.
---------------------------------------------------------------------------
We believe that stem cells derived from human amnion display
several characteristics that suggest that they will be useful for cell
transplantation and regenerative medicine:
1. Amnion expresses markers of pluripotency suggesting that they
may have the capacity to become every cell type in the body.
2. Amnion does not require feeder layers for maintenance of the
stem cells.
3. Amnion-derived stem cells do not form tumors when transplanted.
4. Amnion is freely available because it is normally discarded
following a live birth.
5. Amnion is abundantly available from the over 4 million live
births each year in the United States.
6. Amnion-derived stem cells are obtained from term placenta, and
only following a live birth of a baby. Thus, we believe that there will
be no social, ethical or religious opposition to the use of stem cells
from this source.
My colleagues and I conclude from our initial studies that amnion
derived stem cells may be a useful and non-controversial source of stem
cells for cell transplantation and regenerative medicine. We urge the
United States Congress to support this promising area of research in
every way possible. Thank you.
Senator Specter. We'll now begin the 5-minute rounds of
questions by panelists. Dr. Leshner, I understood you to
testify that you think embryonic stem cell research has the
greatest potential?
Dr. Leshner. Yes, sir, I do. On the basis of the research
that has been done so far, we see that embryonic stem cells
appear to be----
Senator Specter. Would you like to see the restriction on
Federal funding eliminated, so that Federal funds in NIH could
be used on embryonic stem cells?
Dr. Leshner. Absolutely, sir.
Senator Specter. But at the same time you see merit in the
proposal for embryonic stem cells, for shorthand we call it
Specter-Harkin, but you do see the potential for long-range
research on what S. 2754 has, denominated Santorum-Specter?
Dr. Leshner. Absolutely. I would like to see every line
pursued, because we know that cells that have the capacity to
develop into new organs or to repair damaged tissue are going
to have tremendous clinical importance. So I'm in favor of
having all lines of research supported, but I do have to repeat
that in particular we believe that embryonic stem cell research
right now, at this point, has the greatest promise and needs to
be supported.
Senator Specter. Dr. Battey, would you concur with that,
that it is desirable to use all phases, adult stem cells, cord
blood, embryonic, the approach which Senator Santorum has
described here, embodied in S. 2754, known as the Santorum-
Specter bill, all should be pursued?
Dr. Battey. I think it's impossible at this time to know
exactly which source of stem cells will ultimately be most
beneficial for a specific clinical application. Given that
we're in the very early, basic phase of research, I would
support research on stem cells from a wide variety of sources.
Senator Specter. Would you concur with Dr. Leshner that
based on current information, embryonic stem cells have the
best chance, although all others ought to be pursued?
Dr. Battey. They have, human embryonic stem cells have two
unique properties that differentiate them from stem cells from
other sources. They have an unlimited capacity to self-renew in
the laboratory, and so far as we know they have the capacity to
differentiate into any one of the many hundreds of types of
mature cell types. Those two unique properties make them
particularly interesting to the scientific community.
Senator Specter. Would you say, then, that they're the best
available, although all others ought to be pursued?
Dr. Battey. I would say, I would concur with the argument
that we need to look at all different types of stem cells
because we don't yet know which will be the most interesting.
To me, the very most interesting thing, which is on the
very far horizon, is this frontier area of nuclear
reprogramming, where you take a mature adult cell type and you
effectively dedifferentiate it back to a pluripotent state. If
we were able to do this, we could make pluripotent cells from
adult cell types from a patient and then differentiate those
cells into whatever cellular therapy were needed.
So this is, again, an area where we are in the very early
stages. We know that nuclear----
Senator Specter. So you would just like to have lots of
money to work on all these things.
Dr. Battey. Yes.
Senator Specter. Dr. Strom, have you heard Dr. Leshner or
Dr. Battey say anything in response to my questions that you
disagree with?
Dr. Strom. Oh, absolutely not. I think we all agree on
that.
Senator Specter. Well, that's a very good, succinct answer
which saves you further questioning.
As I said at the outset, the Judiciary Committee is having
a hearing at 10 o'clock which I'm going to have to excuse
myself for.
I again want to thank my colleague, Senator Santorum, for
his work above and beyond the call of duty. He has a lot of
responsibilities in a lot of other fields, but he has taken
time to get into this subject very, very deeply, and I can tell
you that he's in it very deeply because we had a lot of
discussions. We spent a lot of time around the conference table
with our staffs to work through the issue and to come up with
this legislation.
Before departing and turning over the gavel to Senator
Harkin, let me welcome Senator Durbin's arrival and tell him
that we'll hold the fort until he gets to the Judiciary
Committee. Don't be too long.
Thank you very much, Senator Harkin, for agreeing to take
over the chair for the balance of the hearing.
Senator Harkin [presiding]. Thank you very much, Mr.
Chairman, and I'll just use my 5 minutes and then yield to
Senator Durbin and Senator Santorum.
Dr. Battey, I guess my question is, and you probably heard
the exchange between Senator Santorum and me on S. 2754, I
guess my question is, does this bill authorize any new activity
that NIH is prohibited from or can't already support?
Dr. Battey. The NIH is already in a position to support
research on alternative methods for deriving stem cells in
animal model systems.
Senator Harkin. For example, what Dr. Strom is doing with
the placenta cells, I mean, that kind of research could be
supported by NIH right now?
Dr. Battey. As a matter of fact, I believe that the
commercial entity with which he is associated has a small
business innovation research grant.
Senator Harkin. So it's being supported?
Dr. Battey. I believe that's true.
Senator Harkin. Is that so, Dr. Strom?
Dr. Strom. I'm actually not part of the company. I really
don't know. You would have to ask the company people.
Senator Harkin. Oh, okay. Well, if you say it is, I'll take
your word for it.
So if a researcher applies to NIH for a grant to study an
alternative method of deriving stem cells, you would give it
the same consideration regardless of whether this bill becomes
law?
Dr. Battey. It would undergo our peer review process, be
judged for scientific merit, and if it received a favorable
priority score, would be funded by one of the 27 institutes and
centers at NIH.
Senator Harkin. Let me ask this: Is NIH currently spending
more money on human embryonic stem cell research or on human
adult stem cell research?
Dr. Battey. In 2005 the NIH estimates that it spent about
$198 million on human stem cell research where the stem cells
come from sources other than the embryo, and in the same fiscal
year we estimate that we spent about $38 million on human
embryonic stem cell research.
Senator Harkin. About six times as much on adult stem
cells, so it would be true that as a Nation we are not
neglecting adult stem cell research, obviously.
Dr. Battey. We have no set-aside allowance for either
embryonic stem cell research or adult stem cell research. We
let the investigator-initiated research grant application
process and the peer review process drive the funding. It's
driven by scientific excellence as judged by peer review.
Senator Harkin. Thank you, Dr. Battey.
Dr. Leshner, do you have any more information or can you
describe the research just published by scientists at Johns
Hopkins, in which embryonic stem cells were used to restore
movement in paralyzed mice or rats? I don't know which it was.
Do you have any more information on that for us?
Dr. Leshner. I don't. I just have a copy of a report of it.
I have to say I don't even know where it has been or will be
published. But it is extremely encouraging, and the technique
fits with the expectation you would have of regenerating
tissue.
Senator Harkin. My last question would be this, Dr.
Leshner. Is there any scientific merit--I'm just talking about
scientific merit, now--to putting all of our hopes for stem
cell research on only the alternative methods without pursuing
embryonic stem cell research?
Dr. Leshner. From the point of view of the scientific
community that I represent, embryonic stem cell research has
tremendous potential and it's critical that it be pursued. My
own belief is that it would be a mistake not to pursue it,
including using the excess embryos from in vitro fertilization
that will be discarded anyway.
Senator Harkin. I guess my last comment is just that it
seems that you pointed out all these countries--Great Britain,
Singapore, South Korea, Israel, Scandinavia--all these
countries have very advanced embryonic stem cell research
programs going on, and I guess I'm not so positioned that we
know it all. I mean, there are good scientists in other
countries around the world. It would seem to me that if they
are pushing hard in that area, it would seem to me that lends
some credence, at least some, to saying there is scientific
merit--scientific merit--to aggressively pursuing embryonic
stem cell research.
Dr. Leshner. I don't think there is any question in the
scientific community about the scientific merit in pursuing
embryonic stem cell research.
Senator Harkin. Thank you very much, Dr. Leshner.
Senator Santorum?
Senator Santorum. Thank you, Mr. Chairman.
Dr. Battey, I just want to pick up on something you said
that I felt was significant. You said that ultimately what you
think would be the optimal is to take adult stem cells and be
able to work them back--dedifferentiate; I think was the term
you used. Is that correct? Is that the term you used?
Dr. Battey. Actually, adult cell types----
Senator Santorum. Adult cell types?
Dr. Battey [continuing]. Such as fibroblasts. Yes, this is
very much now in the pie-in-the-sky category, in terms of our
ability to do this in any kind of systematic way. But certainly
if it were possible to take adult cell types and to drive the
differentiation process backwards so that you made these cells
pluripotent, and then could differentiate them into insulin-
producing beta islet cells for a child with Type 1 diabetes,
then if you began with fibroblasts from that same child, you
would have what we call an isogeneic cell, a cell that was
genetically perfectly matched.
Now, we are many, many years off, I think, from being able
to do this clinically, but I find this is a very exciting area.
Dr. Jenisch's name has been mentioned a number of times, and
certainly he and Kevin Eggan have active research programs to
understand what this nuclear reprogramming is at the molecular
level, and NIH is pleased to be able to provide some support
for these efforts.
Senator Santorum. That would not be considered embryonic
stem cell research, right?
Dr. Battey. It's research on generating pluripotent cells
from adult cell types.
Senator Santorum. Right.
Dr. Battey. But as I mentioned, there is much, much basic
science to be done before we will be able to do this in any
systematic way, and I continue to be of the opinion that we
need to pursue this avenue of research along with stem cells
from a wide variety of sources, so as not to miss any possible
opportunity to help patients that are ravaged by these cellular
degenerative diseases.
Senator Santorum. Agreed, but some have suggested that the
only really good, long-term research that we need to be looking
at, the real pie-in-the-sky stuff, has to do with embryonic
stem cell research, and what you're suggesting is that that's
not necessarily the case. There may be, in fact, other types of
research that could be even better than that long term.
Dr. Battey. Yogi Berra said it best when he said,
``Predictions are difficult, especially about the future.''
When it comes to science, it's very difficult to predict what
the state of the science will be in 2020. It's very difficult
to predict what the state of the science will be in 2012. So
it's dangerous to make predictions, and for that very reason I
think----
Senator Santorum. It's dangerous to make promises, too,
that all these things are going to turn out just the way we
hope them to turn out.
Dr. Battey. Right, but I think it's fair to say that what
we learn in studying how pluripotent cells specialize to become
adult cell types stands a very high probability of informing
the medicine of the future.
Senator Santorum. I agree with that, and as Dr. Strom would
say, we have been in very strong support of that, Senator
Specter and I both, in funding a lot of that research.
I'm just curious with respect to the adult. I know that you
said, when Senator Harkin asked the question about how much
adult stem cell research is being done at NIH versus human
embryonic. Is that basic adult stem cell research, or is that
adult stem cell research that goes to, you know, making bone
marrow transplants more efficient? Or is it really, are we
really talking about six times more research on basic adult
stem cell research, or are you throwing in a lot of other
things that you count as stem cell research?
Dr. Battey. It's a combination of basic translational and
clinical research, and the reason why is that the adult stem
cell world, particularly the bone marrow derived hematopoietic
stem cells, has been a part of the scientific landscape for
many decades, and so----
Senator Santorum. Can you differentiate out how much basic
adult stem cell research that you're doing, as compared to
basic----
Dr. Battey. I'm sorry. I don't have those figures with me
today. I apologize.
Senator Santorum. If you can provide that to me and to the
committee, I would appreciate it, if you can do that.
Dr. Battey. We'll do the best we can, although in a way
you're asking me to draw a line in the sand, because when a
research study goes from being basic to translational is a
little like--you know, it certainly could be described as a
judgment call.
Senator Santorum. I respect that, but I just think it is
important for the record to indicate that while one is six
times as much as the other, you're talking about a whole
variety of different things. Because of the advancement of
adult stem cell research in the past, you get into things that
are not basic research, and so you're comparing basic research
with a whole variety of different research, and it's not
necessarily a fair comparison of what NIH is spending their
money on.
Dr. Battey. I wish we were in a position to begin phase one
clinical trials using cells derived from human embryonic stem
cells, but we have much to learn before we can do that.
Senator Santorum. I'm not arguing that. I just want to make
sure that when you make a funding comparison, you're comparing
apples to apples, and I think in this case it's not necessarily
an apples-to-apples comparison.
So, again, I just thank you for that. I see my time is up,
and I appreciate it. Thank you, Mr. Chairman.
Senator Harkin. Senator Durbin?
Senator Durbin. Thank you very much, Senator Harkin.
As I listen to this exchange, it reminds me of the movie
``Cool Hand Luke,'' where the fellow said, ``What we got here
is a basic failure to communicate.'' We have a panel of real
scientists facing a panel of political scientists, and I think
maybe we're talking past one another here, so I'd like to get
down to some basics.
I understood this hearing was about Senator Santorum's bill
that suggested a new avenue of research at NIH and authorizing
that research. If anyone here on the real scientist panel has
read the Santorum bill, can you tell me whether it authorizes
research on stem cells at the NIH that currently is not
permissible or legal?
Dr. Battey. No, it does not.
Senator Durbin. Does it expand in any way the opportunities
at NIH to do stem cell research?
Dr. Battey. We have been in a position to accept a research
grant application to study alternative ways for deriving
pluripotent cells in animal models for many, many years.
Senator Durbin. So you already have the authority that is
stated in this bill?
Dr. Battey. Yes.
Senator Durbin. What does this bill add, then? I'm sorry
Senator Santorum is gone. It apparently doesn't, from your
answers, it doesn't add anything to the authority of the
National Institutes of Health or our government to do medical
research that might be beneficial, so it may have more
political science impact than real science impact.
Let me ask you this, if I might. When it comes down to this
basic research, the President made an announcement in August
2001 limiting the research on embryonic stem cells. Now, I am a
liberal arts major, so please forgive me if I don't get the
terminology correct, and correct me. I wouldn't be the least
bit embarrassed if you did.
The President limited that embryonic stem cell research to
certain existing lines of embryonic stem cells that were then
in existence, but no more. I would like to ask the panel how
that has limited our research as a government, that
presidential decision, when it comes to embryonic stem cell
research.
Dr. Battey. From a practical standpoint, a scientist with
Federal funding in their laboratory can today order 1 of 21
human embryonic stem cell lines that are eligible for Federal
funding, found in locations at various places around the world.
Senator Durbin. That's it. That's the limitation. Is that
correct?
Dr. Battey. That's the reality.
Senator Durbin. So talk to me about the rest of the world
that is not encumbered by this decision by President Bush to
limit medical research on stem cells. What opportunities do
they have that our government scientists, federally funded
scientists, do not have?
Dr. Battey. Depending on which country you visit, there's a
spectrum of science and technology that can be done in other
countries, that is not eligible for Federal funding in the
United States. Now, let me emphasize ``eligible for Federal
funding,'' because the President's policy pertains only to
Federal funding. At the Federal level there is absolutely no
limitation whatsoever on any of this. It's all legal at the
Federal level. Now, some States have passed laws restricting
activities within the borders of their State.
Senator Durbin. Do the other panelists have anything to add
or disagree or comment?
Dr. Leshner. I think an interesting statistic is that in
the mid-1990's, I believe as recently as 1998, the United
States published over 50 percent of the world's papers annually
on stem cells. We now are publishing under 30 percent. So I
think there is a very significant danger here that we are
ceding the lead in this area of research to other countries.
Senator Durbin. Well, let me say that I have had several
meetings in my State, and I'm sure Senator Harkin has had
similar meetings, with people who are praying that this law
changes, and quickly. Anyone suffering from disease who wants
to keep a hopeful attitude is trusting that their government
continues to do medical research which might spare them from
juvenile diabetes or Parkinson's or spinal cord injuries,
Alzheimer's, Lou Gehrig's disease. The list goes on and on and
on. They cannot understand why the United States of America has
made a political decision to restrict that research.
We all agree that research, including this research, should
have clear ethical guidelines as to how far we can go. We are
all opposed to human cloning. I haven't heard a single Member
of Congress supporting human cloning. That's not even part of
the real discussion here. I think what we have heard from
Senator Specter, Senator Harkin, and I would like to join in
that chorus, is we are in favor of research, expanding
research, finding new cures, within those ethical guidelines.
I came here this morning hoping to find that this bill that
is being discussed at this hearing expanded opportunities for
medical research. What I have heard from this panel is, it does
not. This bill does not add anything to the current authority
and ability of our government to do medical research.
My fear, and I think Senator Harkin expressed it earlier,
is that some of our colleagues will try to hide behind this
bill and say, ``If we endorse this one, then we don't have to
face the bill that came over from the House.'' We're not going
to let them off that easily.
We have had a promise from Senator Frist that stem cell
research will be called for a vote. We're going to hold him to
his promise. He is now in the twilight of his Senate career. He
is leaving soon. We have a few months left, and I'm sure he
wants to keep his word, and we're going to help him keep his
word.
When we return after the 4th of July recess, I think
America is finally going to get its wish. We're going to get a
vote on stem cell research. I'm glad S. 2754 has been
introduced, but it adds nothing to the debate, this important
debate.
Thank you, Mr. Chairman.
Senator Harkin. Thank you, Senator Durbin.
Just in closing, I just wanted to follow up on one that Dr.
Battey responded to on the 21 stem cell lines that are
available for research. I ask Dr. Battey to confirm or deny
what I'm about to say, and that is, I understand that each one
of those lines was derived by propagating those lines on mouse
feeder cells, and that as such they may be in a contaminated
state. In other words, if they have been contaminated by mouse
feeder cells, they may never have the possibility of ever being
used for human therapies. What we need are stem cells lines
that are not derived on mouse feeder cells, but each one of
those 21 I guess were. Now, is that correct or not?
Dr. Battey. Each of the 21 cell lines that a research
scientist with Federal funding can order to do science in their
laboratories has been exposed at one point in its history to a
mouse feeder cell layer. That is correct.
Senator Harkin. I just wanted to make that point.
Do any of you have anything else to add to the hearing at
all? Going, going----
Dr. Strom. If I might, I mean, I think that the debate on
stem cell research has focused in this country almost
exclusively on embryonic stem cells, and the thing I wanted to
bring to the table today is that there are other stem cells and
they also deserve, I think, the interest of the politicians as
well as the scientists. So I think we've been in the shade of a
very large tree for a long time, and we could use a little
sunshine on some of these other stem cell types as well,
though.
Senator Durbin. May I respond?
Senator Harkin. Sure.
Senator Durbin. There is no limitation, is there, by policy
of this administration or by law?
Senator Harkin. The only limitation is on embryonic.
Senator Durbin. That's why we're talking about it.
Dr. Strom. I understand that point, but there is such a
focus on a single stem cell. It's like there is no other stem
cell. Even in a scientific review committee, if you present
something like you are trying to present, they would say,
``Well, why are you not doing this also with ES cells?'' So I'm
just saying that this idea that there is only one stem cell out
there is so pervasive that it does block the sun on some other
opportunities, I think, and I would just like to keep the mind
open.
Senator Harkin. I would just ask Dr. Leshner, why has there
been all this focus on embryonic stem cells, then? It hasn't
been from us. It's been from the scientific community, not from
us.
Dr. Leshner. I think that the scientific community sees it
at the moment as the most promising approach, but as both of my
colleagues have pointed out, there are other approaches. My
view is, subject them to peer review, and that's what we have
NIH for and that's what we have scientific journals for. As
long as alternatives can be supported by NIH and can be
published in peer reviewed journals, hear, hear.
CONCLUSION OF HEARING
Senator Harkin. Thank you all very much for being here.
That concludes our hearing.
[Whereupon, at 10:12 a.m., Thursday, June 27, the hearing
was concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]
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