[Senate Hearing 109-815]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 109-815
 
 ALTERNATIVE PLURIPOTENT STEM CELL THERAPIES ENHANCEMENT ACT (S. 2754)

=======================================================================

                                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


  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                               index.html


                               __________

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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

                              ----------                              
                                                                   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)

                              ----------                              


                        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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