[Senate Hearing 108-958]
[From the U.S. Government Publishing Office]




                                                        S. Hrg. 108-958
 
                     EMBRYONIC STEM CELL RESEARCH:  
                       EXPLORING THE CONTROVERSY 

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

                                HEARING

                               before the

                 SUBCOMMITTEE ON SCIENCE, TECHNOLOGY, 
                               AND SPACE

                                 of the

                         COMMITTEE ON COMMERCE,
                      SCIENCE, AND TRANSPORTATION
                          UNITED STATES SENATE

                      ONE HUNDRED EIGHTH CONGRESS

                             SECOND SESSION

                               __________

                           SEPTEMBER 29, 2004

                               __________

    Printed for the use of the Committee on Commerce, Science, and 
                             Transportation





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       SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION

                      ONE HUNDRED EIGHTH CONGRESS

                             SECOND SESSION

                     JOHN McCAIN, Arizona, Chairman
TED STEVENS, Alaska                  ERNEST F. HOLLINGS, South 
CONRAD BURNS, Montana                    Carolina, Ranking
TRENT LOTT, Mississippi              DANIEL K. INOUYE, Hawaii
KAY BAILEY HUTCHISON, Texas          JOHN D. ROCKEFELLER IV, West 
OLYMPIA J. SNOWE, Maine                  Virginia
SAM BROWNBACK, Kansas                JOHN F. KERRY, Massachusetts
GORDON H. SMITH, Oregon              JOHN B. BREAUX, Louisiana
PETER G. FITZGERALD, Illinois        BYRON L. DORGAN, North Dakota
JOHN ENSIGN, Nevada                  RON WYDEN, Oregon
GEORGE ALLEN, Virginia               BARBARA BOXER, California
JOHN E. SUNUNU, New Hampshire        BILL NELSON, Florida
                                     MARIA CANTWELL, Washington
                                     FRANK R. LAUTENBERG, New Jersey
      Jeanne Bumpus, Republican Staff Director and General Counsel
             Robert W. Chamberlin, Republican Chief Counsel
      Kevin D. Kayes, Democratic Staff Director and Chief Counsel
                Gregg Elias, Democratic General Counsel
                                 ------                                

             SUBCOMMITTEE ON SCIENCE, TECHNOLOGY, AND SPACE

                    SAM BROWNBACK, Kansas, Chairman
TED STEVENS, Alaska                  JOHN B. BREAUX, Louisiana, Ranking
CONRAD BURNS, Montana                JOHN D. ROCKEFELLER IV, West 
TRENT LOTT, Mississippi                  Virginia
KAY BAILEY HUTCHISON, Texas          JOHN F. KERRY, Massachusetts
JOHN ENSIGN, Nevada                  BYRON L. DORGAN, North Dakota
GEORGE ALLEN, Virginia               RON WYDEN, Oregon
JOHN E. SUNUNU, New Hampshire        BILL NELSON, Florida
                                     FRANK R. LAUTENBERG, New Jersey



                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on September 29, 2004...............................     1
Statement of Senator Brownback...................................     1
Statement of Senator Dorgan......................................    28
Statement of Senator Ensign......................................    31
Statement of Senator Wyden.......................................     2
    Article dated September 20, 2004 from The Washington Post 
      entitled, ``Two Studies Bolster Stem Cells' Use in Fighting 
      Disease'' by Rick Weiss....................................     3
    Article dated August 17, 2004 from USA Today entitled, 
      ``Nobel Laureate decrees limits on stem cell research'' by 
      Katharine Webster, Associated Press........................     4

                               Witnesses

Daley, M.D., Ph.D., George Q., Representing the American Society 
  for Cell Biology...............................................    38
    Prepared statement...........................................    40
Doerflinger, Richard M., Deputy Director, Secretariat for Pro-
  Life Activities, U.S. Conference of Catholic Bishops...........    10
    Prepared statement...........................................    13
Hedrick, M.D., Marc, President, MacroPore........................    61
    Prepared statement...........................................    63
Prentice, Ph.D., Dr. David A., Senior Fellow for Life Sciences, 
  Family Research Council; Affiliated Scholar, Center for 
  Clinical Bioethics, Georgetown University Medical Center.......    42
    Prepared statement...........................................    45
Zoloth, Ph.D, Laurie, Professor, Bioethics and Religion, Medical 
  Humanities and Bioethics Program and Director of Bioethics, 
  Center for Genetic Medicine, Feinberg School of Medicine, 
  Northwestern University........................................     6
    Prepared statement...........................................     8

                                Appendix

Article dated March 2004 entitled, ``Voters' Views on Stem Cell 
  Research'' prepared by Peter D. Hart Research Associates for 
  the Civil Society Institute....................................    78
Lautenberg, Hon. Frank R., U.S. Senator from New Jersey, prepared 
  statement......................................................    77


                     EMBRYONIC STEM CELL RESEARCH: 
                       EXPLORING THE CONTROVERSY

                              ----------                              


                     WEDNESDAY, SEPTEMBER 29, 2004

                               U.S. Senate,
    Subcommittee on Science, Technology, and Space,
        Committee on Commerce, Science, and Transportation,
                                                    Washington, DC.
    The Subcommittee met, pursuant to notice, at 2 p.m. in room 
SR-253, Russell Senate Office Building, Hon. Sam Brownback, 
Chairman of the Subcommittee, presiding.

           OPENING STATEMENT OF HON. SAM BROWNBACK, 
                    U.S. SENATOR FROM KANSAS

    Senator Brownback. Call the hearing to order. Thank you all 
for joining us today. If we could have the first two witnesses 
please come up to the table, Senator Wyden and I have opening 
statements and then we'll go with the witnesses.
    We have two votes, starting at 2:15. We'll try to get as 
far along as we can before we take a break. I doubt if we can, 
two votes, back to back. But we want to move as far as we can.
    Calling this hearing, the Senate Subcommittee on Science, 
Technology, and Space, to order. We had a hearing a couple of 
months ago on adult stem cell advances, and I stated at that 
time that we'd be holding one on embryonic stem cell. And 
that's what this hearing is about today. And I appreciate all 
of you being here.
    As Chair of the Science Subcommittee, I called this hearing 
to examine the ethics and scientific advances of 20 years of 
embryonic stem cell research. The first panel of witnesses will 
discuss the ethics of embryonic stem cell research, and the 
second panel will examine the scientific advances of embryonic 
stem cell research.
    It's alleged that human embryonic stem cells are a 
veritable fount of cures for those afflicted with disease; 
however, to date, I am unaware of one person being cured from 
either private or federally funded human embryonic stem cell 
research. In July, this Subcommittee heard testimony from real 
Parkinson's and spinal injury patients whose lives have been 
dramatically improved by adult stem cell treatments. To date, 
45 diseases and medical conditions in humans have been treated 
with adult stem cells, such as those taken from umbilical cord 
blood and placenta tissue where there are no ethical or moral 
problems. We need to put finite Federal dollars where they will 
make the most difference and do no harm.
    We will discuss the issues of cures on the second panel. 
First, we will start with the basic science.
    Science is very clear. Human embryos are living human 
beings at their earliest stages of development. A one cell 
zygote, whether created through fertilization or cloning, is 
human. We all agree it is alive and it is a human; the question 
seems to be, is it a life?
    Science is about the pursuit of truth in the service of 
mankind, and science tells us that the human embryo, whether 
created naturally or in a petri dish, is an organism of the 
species homo sapiens, a human being. To obtain human embryonic 
stem cells, human embryos must be destroyed. Is it right to 
destroy these human embryos, human beings, at the youngest 
stages of life, in order to collect their stem cells?
    I've called this hearing largely because I'm troubled that 
science is being distorted in the debate over human embryonic 
stem cells and that some are even casting doubt on the 
scientific fact that young human embryos are human lives. Make 
no mistake, this issue involves both biology and ethics. That's 
why we have two separate expert panels to discuss each of these 
issues separately.
    Let us be clear, when it is said that human life begins at 
the embryonic stage, biology is being discussed--not ideology, 
belief, or ethics. When it is said that no human life, young or 
old, should be taken, we are discussing the traditional Western 
ethic that have made our nation great.
    A human embryo is, biologically speaking, a young human 
life. It is not a scientific statement to assert that it is not 
a life or that it is a potential life. In fact, to assert that 
a human embryo is not a human life is a belief unsupported by 
the facts. To assert that a human embryo is not a human life is 
inaccurate.
    The topic of human embryonic stem cell research is 
controversial because it touches on the beginnings of human 
life, the value of human life, and respect for human life. 
Human embryonic stem cells force us to consider the fundamental 
questions about the beginnings of human life. And for that, we 
can be thankful. Human adult and non-embryonic stem cells that 
are noncontroversial are yielding results at no cost to any 
living human beings.
    We hope to have a good discussion on this topic today. We 
look forward to the panel and the presentations.
    And I turn to my Ranking Member for an opening statement.

                 STATEMENT OF HON. RON WYDEN, 
                    U.S. SENATOR FROM OREGON

    Senator Wyden. Thank you very much, Mr. Chairman. As you 
know, you and I agree on so many issues in the area of science 
and technology and international affairs and others. And this 
is one where I think even a casual observer of what goes on in 
this Subcommittee is aware that this is one where we do have 
diametrically opposed views. And I want to say, as we go to 
today's hearing, I want to commend you for your fairness, 
because we have always debated these issues in an open and 
straightforward kind of fashion, and you've always been 
eminently fair, and I thank you for it. And I know we're going 
to have a good debate today.
    Just, if I might, Mr. Chairman, a few comments. First, I'd 
like to put into the record an article from the Washington Post 
on Sunday by Rick Weiss, a reporter who specializes in this 
area, and it discusses how human embryonic stem cells, through 
some new experiments that we have seen with the cells, are 
producing some very significant results. One of the reports 
discussed in the article discusses how stem cells, for the 
first time, are now a cell crucial to vision. They can become a 
cell that is crucial to this area that is of concern to so many 
patients. I would just ask that that be made a part of the 
record.
    Senator Brownback. Without objection.
    [The information referred to follows:]

                The Washington Post--September 26, 2004

        Two Studies Bolster Stem Cells' Use in Fighting Disease

                             By Rick Weiss

    The prospect of using human embryonic stem cells to treat disease 
appears a small step closer as the result of two new experiments with 
the cells, which are mired in political controversy because they are 
derived from human embryos.
    In one report released yesterday, researchers showed that the 
versatile cells can serve as ``biological pacemakers,'' correcting 
faulty heart rhythms when injected into the failing hearts of pigs.
    In another report, scientists demonstrated for the first time that 
stem cells can become a cell crucial to vision. Many doctors believe 
that several vision-destroying diseases could be fought by 
transplanting these cells directly into the eyes.
    Human embryonic stem cells, derived from five-day-old embryos, have 
the biological potential to morph into virtually all of the 200 or so 
kinds of cells in the body. Researchers are racing to learn how to 
direct them to develop into specific types of cells that can be 
transplanted into failing organs. It is an approach that could launch a 
new era of regenerative medicine--but only if the cells prove capable 
of integrating into existing organs and functioning normally there.
    Izhak Kehat and Lior Gepstein of the Technion-Israel Institute of 
Technology in Haifa and their colleagues sought to test that capacity 
with stem cells that were growing into heart muscle cells.
    The team started with masses of stem cells growing in laboratory 
dishes, from which they isolated those few that were spontaneously 
developing into heart cells.
    They were easy to spot: They were the ones that were pulsing in 
unison, as heart cells are apt to do.
    In one experiment, the scientists isolated small balls of the human 
cells--each ball about the size of the head of a pin, or about 1 
million cells--and placed that little mass into a lab dish with rat 
heart cells.
    The cells of each species, rat and human, beat at different rates 
at first. Within 24 hours of living together, however, the combined 
masses of cells coordinated their pulsing into a single rhythm.
    ``At least in the dish, they integrated structurally, mechanically 
and electrically,'' Gepstein said.
    But could stem-derived heart cells help set the pace of a heart in 
a live animal?
    To find out, the team threaded a probe into the hearts of 13 pigs 
and made a small burn in the area that regulates the heart beat, 
causing a permanent severe slowing of those animals' heart rates. The 
injury mimicked a human heart rhythm disorder that could be caused by 
disease or a small heart attack.
    Then they injected about 100,000 of their human embryo-derived 
heart cells into the damaged pig hearts. Eleven of the 13 returned to 
faster heart rates, the team reported in yesterday's advanced online 
edition of Nature Biotechnology. There was no improvement in control 
animals that did not receive the cells.
    ``It's not like tomorrow people are going to be waiting in line for 
biological pacemakers,'' Gepstein said. ``But we were happy to see 
after a few days a new rhythm arose,'' providing what he called ``proof 
of principle.''
    A second report--appearing in the fall issue of the journal Cloning 
and Stem Cells--describes the first documented growth of retinal 
pigment epithelial cells, or RPE cells, from human embryonic stem 
cells.
    RPE cells, which are related to nerve cells, live inside the eye 
and provide essential ``housekeeping'' duties for the rods and cones--
the light-sensitive cells in the retina. RPE cells scavenge the retinal 
area for cellular debris, sucking old material up like little vacuum 
cleaners. And they secrete substances that aid in tissue repair within 
the eye.
    The loss of RPE cells in middle and old age is a major cause of 
age-related vision loss, including macular degeneration. That disease 
is the leading cause of blindness in people older than 60, affecting 30 
million people worldwide. Doctors have begun to experiment with RPE 
cell transplants into people's eyes, but the approach has been plagued 
by problems--including an inadequate supply of cells.
    In experiments led by Irina Klimanskaya and Robert Lanza of 
Advanced Cell Technology in Worcester, Mass., human embryonic stem 
cells grown in lab dishes under certain conditions spontaneously became 
RPE cells, offering a possible solution to the supply problem.
    Moreover, the ACT system involves no animal cells or products--a 
feature the Food and Drug Administration has said will be important as 
it considers granting permission to test stem cell-derived cells in 
people.
    Lanza said the company hopes to complete transplant studies in 
large animals during the next year, after which it will apply for 
permission to test the cells' safety and therapeutic value in the eyes 
of people with RPE-related vision loss.
    Not all stem cell colonies worked equally well, Lanza noted, 
touching on a hot area of political debate. Six of the colonies--those 
developed by Harvard researcher Douglas Melton with private funds--
``worked like a charm,'' Lanza said, as did two colonies developed by 
ACT.
    But the three colonies developed by a Wisconsin team--among the few 
approved by President Bush for study with Federal dollars--worked only 
``very reluctantly,'' Lanza said. Bush has banned Federal funding for 
research on newly derived stem cell lines in order not to encourage the 
destruction of human embryos, but Lanza said his work shows that policy 
is short-sighted.
    ``It's becoming clear that each colony is different and can do 
different tricks,'' Lanza said. ``To limit federally funded research to 
just a handful of lines is a mistake.''

    Senator Wyden. Mr. Chairman, as we all know, the President, 
a number of years ago, limited Federal-funded research in this 
area to what amounts to literally just a few more than existing 
cell lines. Now only 21 of the initial 78 stem cell lines seem 
to be available to researchers, and it's recently been 
reported--and I'd ask that this article be made a part of the 
record, as well--that more than a hundred new lines have been 
developed since the President's cutoff date, and now we have 
many that are much better suited for research. And I'd like an 
article that addresses that point to be made a part of the 
record, as well.
    Senator Brownback. Without objection.
    [The information referred to follows:]

                       USA Today--August 17, 2004

          Nobel laureate decries limits on stem cell research

                 By Katharine Webster, Associated Press

    MANCHESTER, N.H.--A Nobel laureate in medicine says the Bush 
administration's limits on funding for embryonic stem cell research 
effectively have stopped the clock on American scientists' efforts to 
develop treatments for a host of chronic, debilitating diseases.
    ``This is a topic of science and medicine, but it's a topic that's 
become embroiled in politics,'' H. Robert Horvitz, a Massachusetts 
Institute of Technology biologist, said Monday at an Elliot Hospital 
forum organized by Democratic presidential nominee John Kerry's 
campaign.
    Embryonic stem cells are cultured from leftover, 5-day-old embryos 
created for infertility treatment. They would be discarded if not used 
for research, with the permission of the infertile couple, Horvitz 
said. Embryonic stem cell lines were first successfully cultured in 
1998.
    Three years ago, President Bush--concerned that harvesting the 
cells required the destruction of human embryos--limited federally 
funded research to a few dozen existing cell lines.
    Only 21 of the initial 78 stem cell lines are available to 
researchers now. Scientists say more than 100 new lines have been 
developed since Bush's cutoff date, some of which are much better 
suited for research.
    Horvitz also said researchers need access to diverse embryonic stem 
cell lines so they can develop treatments that are good genetic matches 
for patients of different races and ethnic backgrounds.
    Horvitz, whose father died of Lou Gehrig's disease, said research 
and treatments derived from embryonic stem cells have the potential to 
help future sufferers of brain diseases, diabetes, heart disease, 
multiple sclerosis and cancer.
    ``Some people who oppose embryonic stem cell research say the 
problem of curing these diseases is very far in the future,'' he said. 
``My response is: Let's get on with it.''
    Embryonic stem cell research will not yield quick results in some 
areas, but in others, treatments could be available within a decade, he 
said.
    ``In 10 years, a child with a spinal cord injury may be able to 
walk--if we start now,'' the 2002 Nobel Prize winner said.
    Ann McLane Kuster, vice-chairwoman of New Hampshire Women for 
Kerry, made an emotional appeal for lifting the restrictions. Her 
mother, former Republican state Sen. Susan McLane, suffers from 
Alzheimer's and no longer can stand or speak, she said.
    ``Advances in stem cell research are being held hostage by the 
extreme right,'' she said. ``This is emotional. This is about our 
future, our children, our parents, and we cannot let ideology determine 
our future.''
    She said it is a bipartisan issue, noting that U.S. Reps. Charles 
Bass and Jeb Bradley, both New Hampshire Republicans, support lifting 
the restrictions.
    Speaking for the Bush campaign at a muddy baseball field near the 
hospital, state Rep. Rogers Johnson, R-Stratham, accused the Kerry 
campaign of ``using stem cell research for purely political gain.''
    ``There are people leading with their hearts on this issue, and I 
feel for them,'' he said. But, ``Alzheimer's is not likely to be 
something you can cure using embryonic stem cells.''
    Because treatments are far in the future, there is no harm in 
proceeding cautiously with a debate on the ethical issues, he said.
    Johnson also noted that Bush was the first president to authorize 
any Federal spending on stem cell research. However, most of the money 
has gone to research on adult stem cells, not embryonic cells.

    Senator Wyden. Perhaps my biggest single concern at this 
point, Mr. Chairman, is the fact that because all over the 
country our citizens are so frustrated with the restrictions on 
research at the Federal level, we now see states--California is 
the latest--essentially taking off on their own. They are 
simply saying, as the result of enormous grassroots pressure in 
various parts of the country, that they're not going to abide 
by the Federal Government's policy of inaction and stonewalling 
on this issue, and they're, in effect, going to go to their 
constituents and start their own program.
    And what troubles me is, as a result of these Federal 
restrictions--in terms of funding, in particular--we are going 
to see states all over America essentially go off and do their 
own thing. And, at a minimum, I think we are going to end up 
with what amounts to a crazy quilt of rules and certainly 
ethical kinds of standards, at a minimum. We'll see California 
take one approach, another area--New Jersey will perhaps take 
another approach; we'll have a set of rules at the Federal 
level.
    And what the scientists have been telling us, what the NIH 
scientists who have been writing in on this have said, that 
it's important that there be one ethical standard. We need to 
have one ethical standard so that it is clear that we can 
address some of the concerns that we're going to hear about 
today. I know they're heartfelt. Witnesses who have a different 
view of this issue than I do are going to raise legitimate 
ethical concerns. We do need one strong Federal ethical 
standard, rather than this mishmash, a kind of crazy quilt of 
rules that I think we're going to end up with, and end up very 
quickly with, as a result of the frustration that we are seeing 
around this country.
    So this is a timely hearing. It's timely because of the new 
evidence reported about the potential for human embryonic stem 
cells just this week. It's important because we are seeing that 
there are a lot of new stem cell lines that are available since 
the President's cutoff date. And it is timely because, once 
again, with this California ballot measure, we are going to see 
the consequences where we have what amounts to, I think, sort 
of, scientific chaos as people try to figure out what the rules 
are in an area that really cries out for a responsible, 
thoughtful approach that ensures that the research can go 
forward that is of such promise for our citizens, while, at the 
same time, addressing the ethical concerns that you and a 
number of our witnesses appropriately highlight.
    So I look forward to working with you today, Mr. Chairman, 
and in the days ahead. I suspect that this will not be our last 
hearing on the subject, and know that you will, as you have 
been in the past, be very fair.
    Senator Brownback. Thanks. And thank you for how you've 
always conducted yourself in these discussions, and I 
appreciate that greatly.
    And I hope today can be a good hearing and discussion of 
the issues, where there can be a candid discussion of the 
thoughts, both ethical and scientific, as we really try to take 
an in-depth look at the overall issue. And I know you share the 
desire to do that, as well.
    We're going to go ahead with the presentations and start, 
even though we're likely to have interruption with a vote 
taking place.
    The first panel is an ethics panel. We'll have Dr. Laurie 
Zoloth. She's the Director of Bioethics, Center for Genetic 
Medicine, Professor of Medical Ethics and Humanities, and a 
Professor of Religion at Northwestern University in Chicago. 
Delighted to have you here. And Mr. Richard Doerflinger, Deputy 
Director of the U.S. Conference of Catholic Bishops here in 
Washington, D.C. Mr. Doerflinger, delighted to have you here.
    Dr. Zoloth, please proceed with your presentation, and then 
we'll go with Mr. Doerflinger, and we'll have questions.

          STATEMENT OF LAURIE ZOLOTH, Ph.D, PROFESSOR,

         BIOETHICS AND RELIGION, MEDICAL HUMANITIES AND

          BIOETHICS PROGRAM AND DIRECTOR OF BIOETHICS,

   CENTER FOR GENETIC MEDICINE, FEINBERG SCHOOL OF MEDICINE, 
                    NORTHWESTERN UNIVERSITY

    Dr. Zoloth. Mr. Chairman, Mr. Wyden, I want to thank the 
Committee for asking us to testify why my university supports 
human embryonic stem cell research. It's part of our broad 
commitment to the translation of basic medical science into 
healing. Serving the public's health is the core moral gesture 
of the medicine we teach. Basic research is free speech that 
must both be funded and regulated in full view of the public.
    As I wrote this testimony, my tenth grader was also writing 
a speech about stem cells. It's a big topic in our democracy. 
And, like each of you, I worry about the sort of moral universe 
I will leave to my children.
    I've listened carefully to the scientific researchers, and 
I'm convinced by the growing body of evidence both that these 
cells can be made into some useful tissue, and that research on 
them can explain the nature of how disease works at the 
cellular level, and this is stunningly important. If even some 
of what we are told to hope for is correct, then how we think 
about illness and injury will be transformed.
    So what ethical considerations are a barrier to the full 
funding of this science? There are three: how we get the cell, 
where we get the cell, and what we use them for.
    First is the moral status of the human blastocyst and our 
duties toward it. Second is the process that researchers need 
to get eggs and sperm donated fairly and safely, and our duties 
to donors. Finally, if researchers can find successful 
therapies, how will only good goals of medicine be pursued, and 
access to the cures be fair?
    I think we can agree about the duties of justice and 
science and how we must treat human research subjects, but we 
cannot come to an agreement on what most divides us here today: 
when human life begins. This is a profoundly religious question 
in a profoundly religious country profoundly dedicated to the 
proposition that our freedom to faithfully interpret our faith 
is the core of American life.
    For nearly all Jews, most Muslims, many Buddhists, many 
Protestants, it is not only permissible to use human 
blastocysts to create stem cell lines, it is morally 
imperative--it must be done if it can lead to saving lives.
    As an orthodox Jew, I understand the blastocysts made in 
the lab at the very first stages of division is, at that 
moment, a cluster of cells, and does not have the moral status 
of a human child. It lacks a mother's womb, its existence is 
only theoretical without this, and it is far before our 
tradition considers it a human person.
    I respect that there is a difference in theology. And while 
I understand your passion and the conviction of those for whom 
the blastocyst is a person from the moment of fertilization, I 
do not believe that it is; and it is a matter of faith for me, 
as well. My passion and my conviction are toward the suffering 
of the one I see in need. For Jews, the commandant to attend to 
the suffering is core to my faith. Jewish organizations, from 
Hadassah to the Rabbinic boards of Jewish organizations, speak 
in one voice on this matter: stem cell research is an activity 
of pikuach nefesh, saving and healing broken lives, and of 
tikkun olam, repairing an unfinished natural world.
    What are you to do, as leaders, when we do not want to 
compromise our faith positions? I suggest we must learn to 
compromise our public policies. We do it for other deeply felt 
issues. We did not agree when life ended, but when heart 
transplants became a possibility, Harvard convened a committee 
to set criteria for brain death, an imperfect, but usable, 
compromise that allowed transplant research to develop. The 
U.S. now leads the world in successful transplant surgical 
techniques. We still do not agree, but we publicly fund this 
research, allowing each family and physician to make private 
choices.
    In the last 6 months, I have traveled to three countries to 
look at their stem cell research and meet with their 
scientists--in Israel, in England, and Korea. In each of these 
places, I also met with the bioethicists and philosophers, who 
demanded careful, national, and public oversight. What I saw 
was impressive. These countries understood that turning their 
full attention to science is not only prudent in our global 
society, it is compassionate, it is the right thing to do to 
shape your country's future toward healing.
    Ought we to tremble when we cross such a threshold of human 
knowledge? Of course. For we are being asked to understand 
things that were impossible to know a decade ago. Of course, we 
need to think soberly about the possibility that research may 
still fail utterly or lead us into dangerous places. That is 
the very nature of free research. Courage to face the problem 
will mean a compromise that can be regulated.
    I would urge a far broader policy than our American 
scientists face now, for it is too late to ban the basic 
science of human embryonic stem cells. Where that road may turn 
us to is unknown, but what is certainly known is that if we, as 
Americans, turn aside, we will watch others pass us by. Our 
challenge will be how to live bravely and decently in a complex 
world of difficult moral choices.
    I tell my son that he must write about the core question of 
ethics, ``What must I do about the suffering of the other 
person?'' Stem cell science reminds us that we are most human 
when we act as healers. We are the most free when we can 
explore what we don't yet know. And we are bound by a duty to 
shape our work, always to care for the person in need.
    Thank you.
    [The prepared statement of Dr. Zoloth follows:]

  Prepared Statement of Laurie Zoloth, Ph.D, Professor, Bioethics and 
  Religion, Medical Humanities and Bioethics Program and Director of 
 Bioethics, Center for Genetic Medicine, Feinberg School of Medicine, 
                        Northwestern University
The Ethical Issues in Human Embryonic Stem Cell Research
    Mr. Chairman, Senators:

    My name is Laurie Zoloth, and I am a professor of bioethics and 
religion in the Medical Humanities and Bioethics program, and director 
of bioethics at the Center for Genetic Medicine at the Feinberg School 
of Medicine, Northwestern University in Illinois. I want to thank the 
Committee for asking us to testify about the ethical issues in human 
embryonic cell research, and tell you why my University and many of the 
organizations in which I serve--the Howard Hughes Medical Institute, 
the International Society for Stem Cell Research, the AAAS, the NAS, 
support and encourage human embryonic stem cell research. First, for it 
is part of our broad commitment to the translation of basic medical 
research into the great moral enterprise of healing--serving the 
public's health is the core moral gesture of the medicine we teach. 
Second, we support stem cell research as a free academic activity, like 
free speech, that must be protected and sustained in our University and 
that must be both funded and regulated in full view of the public.
    As I wrote this speech, my 10th grader was also writing a speech 
about stem cells--I note this not tangentially, nor merely to remind 
that I am a mother of five, and I, like each of you, worry about the 
sort of moral universe I will leave to my children, but to stress how 
central this debate has become in our American democracy--it is the 
subject of how we speak of healing and our duty to heal, and it is the 
subject when we speak of human dignity, and it is how we express our 
hope and our fear of the future. Stem cells are important in this way 
because of the serious rumor of hope they carry for millions of 
yearning patients and families. As an early watcher of the science of 
stem cells, I have listened carefully to the excitement of the 
researchers, and while ethicists urge caution and avoid hyperbolic 
claims, most ethicists are convinced that the sincerity and veracity of 
a growing body of evidence about how these cells can be coaxed into 
useful tissue, and how these cells can explain the very nature of how 
cells grow, change and divide and die--in short, how disease plays out 
at the cellular level--is stunningly important. If even some of what we 
are told to hope for is correct, then how we think about illness and 
injury will be transformed.
    So why do ethical considerations stop full funding of this science? 
I would argue that there are three issues: where we get the cell, how 
we get the cell and what we use them for. First, is the issue of the 
origins of the cells, which means the moral status of the human 
blastocyst--can we destroy blastocysts, made in the lab, for any 
purpose? Can we do it for medical research and why or why not? Second 
is the process that researchers need to get eggs and sperm donated 
fairly and safely and responsibly, and handled with dignity. How are 
women's special needs protected? How do we protect human subjects in 
the first stages of this research? Finally, if researchers can find 
successful therapies, how will good goals of medicine be protected, and 
access to the therapies be fair? Can we come to agreement on the proper 
ends of medicine?
    Stem cells are interesting to ethicists for precisely the same 
reason that they are intriguing to the market--they represent a 
therapeutic intervention that, unlike heart transplants, could be 
universally available, replicable and scaleable. If the daunting 
problems of histocompatibility can be overcome, embryonic stem cells 
could be made universally acceptable to anybody. Unlike adult stem 
cells, which would have to be created each time for each particular 
user, the premise of application is the wide use. Bioethicists defend 
high intensity interventions like organ transplant, which have saved, 
albeit at high cost, thousands of individuals. But organ transplants 
are terribly expensive, and always rationed, and the risks 
considerable. Stem cell research is aimed at a wider community of 
vulnerable patients, and at no one particular category, age, ethnicity, 
or class. The sort of injury and diseases that stem cells are indicated 
for are not boutique, or rare--cell death and cell growth is at the 
core of nearly all disorders. Research into these essential causes 
would be precisely the sort of research we ought to insist on. Further, 
understanding how embryonic cells are programmed and reprogrammed might 
allow us to understand how to de-program cells, allowing adult cells to 
regenerate, teaching the body to heal itself. The demand for justice 
and the scrutiny to which genetic medicine is given are indications 
that we understand the power of genetics to reconfigure the self, and 
the society--in this way, the very debate about stem cells forces 
precisely the justice considerations that I would argue must be a part 
of medicine. The principle of justice places a priority on the public 
aspects of research--on public funding and on public oversight review 
boards for protocols.
    I think we can come to some agreement--around the duties of just 
medicine, and just science, and we have in the past come to agree on 
the how we must treat human research subjects and regulate that 
process, but I think we cannot come to some sort of agreement on what 
most divides us today--when human life begins, for this is a profoundly 
religious question in a profoundly religious country, profoundly 
dedicated to the proposition the our freedom to faithfully interpret 
our faith is the core of American life. For nearly all Jews, most 
Muslims, many Buddhists, and many Protestants, it is not only 
permissible to use human blastocysts to create stem cell lines, it is 
morally imperative--it must be done if it can lead to saving lives or 
healing. As an orthodox Jew, I understand the blastocyst, made in the 
lab, at the very first stages of division, prior to the time it could 
even successfully be transferred to a women's body as just what it is 
at that moment: a cluster of primitive cells. It does not have the 
moral status of a human child--it lacks a mother's womb, it existence 
is only theoretical without this, and even in the course of a normal 
pregnancy a blastocyst at 3 days is far before our tradition considers 
it a human person. While I respect that this is a difference in 
theology, and while I understand the passion and the conviction of 
those for whom the blastocyst is a person from the moment of 
fertilization, I do not believe this, and it is matter of faith for me 
as well. My passion and my conviction are toward the suffering of the 
one I see in need, ill, or wounded--for Jews and Muslims, the 
commandment to attend to this suffering is core to our faiths. Jewish 
organizations from Hadassah to the rabbinic and lay boards of all 
national Jewish denominations speak in one voice on this matter: human 
embryonic stem cell research is an activity of pikuach nefesh, saving 
and healing broken lives, and of tikkun olam--repairing an unfinished 
natural world.
    What are you to do, as leaders of our polity when we will not 
compromise faith positions? I suggest we must learn to compromise our 
faith policies--we do for other deeply felt issues and we must in this 
case as well. For example: we did not agree when life ended, but when 
heart transplants became a possibility, Harvard convened a committee to 
set criteria for ``brain death''--an imperfect, biologically ragged, 
but useable compromise that allowed transplant research to develop. The 
U.S. leads the world in successful transplant surgical techniques--and 
yet some faiths do not agree on these criteria. We do not agree on 
prenatal diagnosis, yet this is widely done, as is IVF even if it means 
embryos are destroyed to get one successful pregnancy. We do not agree, 
but we publicly fund and publicly go forward with research about these 
polices and we allow each family and physician to make private choices. 
We do this by a combination of courage and compromise--you shape our 
policy in different ways: Republicans in one way, Democrats in another, 
but both allow for research to go forward with limits, based in time, 
or geography. Now it is time to revisit these limits.
    In the last six month, I have traveled to three countries to look 
at their stem cell research and meet with their scientists: Israel, 
England and Korea. In each of these places, I also met with the 
bioethicists, philosophers, legal scholars and theologians who reflect 
on the research--who have demanded the same sort of careful, national, 
and public oversight I would think ethically important. What I saw was 
impressive--and for this committee in particular, critical. I saw that 
these countries understood that basic research in biology would be a 
core driver of their economy, that the knowledge, wisdom and energy 
that inspired that research would open the door to a world of new 
possibilities, some false starts, to be sure, but perhaps-just 
perhaps--some new starts. These countries understand that turning their 
full attention to science is not only prudent in our competitive global 
world, it is compassionate--it is the right thing to do to shape your 
country's future toward healing the needs of the suffering. In South 
Korea's labs, they meet at dawn to begin the work every single day, 
working with the same passion and government support we give to our 
Mars Rover programs, for example.
    Ought we to tremble when we cross such a threshold of human 
knowledge? Ought we to worry that we may be going too far or too fast? 
Of course, for we are being asked to understand the world differently, 
the self differently, what it means to be human and to be unique, 
differently--to know and to see things which were impossible to know or 
see a decade ago. Of course we need to think soberly about the 
possibility that the research may fail utterly, or that it may succeed 
but lead us into a place of great unpredictability--that is the very 
nature of research--that is why the future is what makes us free, this 
uncertainty.
    Courage to face the problem will mean a compromise that can be 
regulated, as we did with recombinant DNA, as we did in organ 
transplantation. I would urge a far broader and more open policy than 
our American scientist face now, for it is far too late to stop, ban, 
or have a moratorium on the basic science of human embryonic stem 
cells--it not only will proceed, it has proceeded, in Asia, Israel, 
Europe and England. Stem cell research will now clearly be a possible 
road. Where that road might turn us is unknown--but what is certain is 
that if we turn off the road, we will watch others pass us by. Our 
challenge-and this means each of us--scientist, citizen, congregant, 
critics and enthusiast--most of all Senator--will be how to live 
bravely and decently and fairly in a complex world of difficult moral 
choices. Can stem cell research yield therapies that could help 
millions who now suffer? Will it yield cures for diabetes, Parkinson's, 
spinal cord injury? Who can yet know? If it were able to help even 
some, that might be light enough in the storm filled world. I tell my 
son that he must raise these questions, the core questions of ethics 
and of biology--How are we human? How will we be free? What must I do 
about the suffering of the other person? And that stem cell science can 
remind us that we are most human when we act as healers, we are the 
most free when we explore what we don't yet know, and we are bound to a 
duty to shape our work to care always for the person in need.
    Thank you.

    Senator Brownback. Thank you very much, Dr. Zoloth.
    Mr. Doerflinger?

              STATEMENT OF RICHARD M. DOERFLINGER,

     DEPUTY DIRECTOR, SECRETARIAT FOR PRO-LIFE ACTIVITIES,

              U.S. CONFERENCE OF CATHOLIC BISHOPS

    Mr. Doerflinger. Thank you, Mr. Chairman.
    Our longer written statement has been submitted for the 
record. I would like to review three points.
    First, the need for ethical safeguards in human research. 
The ethical issue raised by this research arises whenever 
proponents of unlimited research freedom complain that ethical 
restraints get in the way of ``progress.'' The Nuremberg Code 
and other declarations have affirmed that human life and 
dignity must not be trampled on in the pursuit of medical 
knowledge useful to others. Yet American scientists, and others 
dazzled by visions of technical progress, are tempted to 
endorse a utilitarian ethic, and to treat helpless or unpopular 
members of the human race as mere means to their ends. When 
society has dropped its guard and failed to set clear limits, 
we ended up with the Tuskegee syphilis experiment, the infamous 
study at Willowbrook Children's Home in New Jersey, our 
government's Cold War radiation experiments, and other even 
more recent scandals. This same utilitarian approach drives 
those who pursue harmful experiments on human embryos today.
    Because scientists and the for-profit companies that 
increasingly support and use their research are tempted to 
mistreat helpless members of the human family, society, 
including government, must supply the urgently needed barrier 
against the inhuman use of human beings.
    Second, the moral status of the human embryo. Some with a 
vested interest in embryo research claim, and have testified 
before Senate committees, that the early human embryo is more 
like a goldfish than a human being, or at least has that moral 
status. But that's based on scientific ignorance. The 
continuity of human development and the reality of the embryo 
as a living organism of the human species, has actually been 
underscored by recent biological discoveries. The embryo is 
also recognized and respected as a member of the human family 
in numerous areas of Federal law.
    Catholic moral teaching holds that human life has intrinsic 
dignity, not only a relative or instrumental value. Thus, every 
living member of the human species, including the embryo, must 
be treated with the respect due to a human person. To reject 
that position is to risk undermining the inherent and 
inalienable rights of human beings after birth as well, to turn 
these into mere privileges gained or lost depending on one's 
mental and physical abilities.
    But even those who do not hold the human embryo to be a 
full-fledged human person can find embryonic stem cell research 
unethical. Setting aside debates on personhood, surely no one 
prefers funding research that requires destroying human life.
    Four major advisory groups recommending Federal policies on 
human embryo research over two decades, three of them under 
Democratic administrations, have agreed that this research 
destroys human lives that deserve our respect. It's a simple 
biological fact. It is absurd to treat a human life solely as a 
source of spare parts for other people and claim that this 
demonstrates your respect for that life. The claim that the 
only embryos to be destroyed for research are those who ``would 
have been discarded anyway'' fails as a moral argument--all of 
us will die anyway. That gives no one the right to kill us. But 
that claim also misunderstands the consent process at fertility 
clinics. It would violate their professional code to take the 
embryos slated to be discarded and use them for research 
instead, or vice versa. They're two mutually exclusive 
categories of embryos.
    In 1999, the National Bioethics Advisory Commission under 
President Clinton tried to explain what respect for the embryo 
might mean in the research context: ``In our judgment, the 
derivation of stem cells from embryos remaining following 
infertility treatments is justifiable only if no less morally 
problematic alternatives are available for advancing the 
research.''
    The burden of proof needed to justify destructive embryo 
research by NBAC's ethical standard has never been met. 
Scientific and practical barriers to the medical use of 
embryonic stem cells now loom larger than many expected. 
Meanwhile, non-embryonic stem cells and other alternatives have 
moved quickly into promising clinical trials for a wide array 
of conditions, including spinal cord injury, Multiple 
Sclerosis, Parkinson's disease, and heart damage, to name just 
a few.
    Proponents' response to that evidence has been simply to 
abandon the Bioethics Commission's standard. They are losing 
the game, and have decided to move the goal post. What is now 
heard is that research using both embryonic and non-embryonic 
stem cells must be equally funded now to determine which source 
is best for various functions. But that would be justifiable 
only if the embryo deserves no respect at all, if it really 
were a goldfish and not a human being.
    In short, Federal funding of embryonic stem cell research 
fails even the test offered by its proponents when they advised 
the Federal Government on this issue 5 years ago.
    Third, the ethical slippery slope. The campaign for 
expanded Federal support for embryonic stem cell research 
cannot achieve its medical goals without violating even more 
ethical norms. Some claim the stem cells now eligible for 
Federal funds are inadequate in number and contaminated by the 
mouse feeder cells in which they are cultured. They say new 
cell lines, like those recently created with private funds at 
Harvard, must now be used.
    But the cell lines already eligible for funding seem 
adequate for their intended task: conducting basic research on 
the advantages and disadvantages of these cells. Moreover, the 
new Harvard cell lines have the same deficiencies as those 
already eligible--they were grown on mouse feeder cells, as 
well--and have already developed serious genetic abnormalities 
typical of cancer cells, the researchers say, to be exact, 
typical of testicular cancer.
    The cell lines that could be obtained by killing all the 
frozen embryos now available for research nationwide would 
still be inadequate in sheer number and genetic diversity to 
treat any major disease. To solve this problem, some 
researchers propose creating a new genetically diverse bank of 
cell lines by creating and killing numerous embryos solely for 
research, including a disproportionate number of embryos 
conceived by members of racial minorities who are under-
represented at fertility clinics. Others have declared that 
mass production of new embryos by cloning will be essential.
    Either way, the logical conclusion is this. Unless you are 
willing to commit yourself in the future to the mass production 
of human lives solely to exploit and destroy them, there is no 
point in funding research using so-called excess embryos now.
    And there is yet another moral line to cross, beyond this. 
For the effort to get so-called therapeutic cloning to work in 
animals has generally succeeded only when cloned embryos are 
implanted in a womb, developed to later fetal stages, then 
aborted for their tissues. The biotechnology industry has 
supported bills in many states to authorize such fetus farming 
in humans, has helped pass such a law already in New Jersey, 
and now supports a ballot initiative in California that could 
end up requiring the use of state funds to promote it.
    In short, the promise of this approach is too speculative, 
and the cost too high. That cost includes the early human lives 
destroyed now and in the future, the exploitation of women for 
their eggs and perhaps in the future for their wombs, and the 
diversion of finite public resources away from research avenues 
that offer real reasons for hope for patients with terrible 
diseases. Let's agree to support avenues to medical progress 
that we can all live with.
    Thank you.
    [The prepared statement of Mr. Doerflinger follows:]

    Prepared Statement of Richard M. Doerflinger, Deputy Director, 
   Secretariat for Pro-Life Activities, U.S. Conference of Catholic 
                                Bishops
    I am Richard M. Doerflinger, Deputy Director of the Secretariat for 
Pro-Life Activities at the U.S. Conference of Catholic Bishops. On 
behalf of the bishops' conference I want to thank this Subcommittee for 
asking us to present our views on the ethics of human embryonic stem 
cell research.
I. The Need for Ethical Safeguards in Human Research
    The central ethical issue raised by this research is raised 
whenever proponents of unlimited research freedom complain that ethical 
restraints get in the way of ``progress.'' This tension between 
technical advance and respect for research subjects is at least as old 
as modern medicine itself. As soon as Western thinkers began to see 
medicine as a science that could advance and acquire new knowledge, the 
temptation arose of using human beings as mere means to this end.
    When Dr. Claude Bernard sounded an alarm against this temptation in 
the 19th century, the preferred victims were prisoners convicted of 
serious crimes. He insisted that the physician must not deliberately do 
harm to any human being simply to acquire knowledge that may help 
others:

        The principle of medical and surgical morality, therefore, 
        consists in never performing on man an experiment that might be 
        harmful to him to any extent, even though the result might be 
        highly advantageous to science, i.e., to the health of others. 
        But performing experiments and operations exclusively from the 
        point of view of the patient's own advantage does not prevent 
        their turning out profitably to science.\1\
---------------------------------------------------------------------------
    \1\ Claude Bernard, An Introduction to the Study of Experimental 
Medicine (1865), quoted in Stephen Post, Inquiries in Bioethics 
(Georgetown University Press 1993), at 145.

    In 1865, Dr. Bernard was already making the important distinction 
between therapeutic and nontherapeutic experimentation. The fact that 
an experiment may benefit the research subject is only one moral 
requirement among others; but it is one thing to provide a human being 
with an experimental treatment whose outcome may also help in treating 
others in the future, and quite another thing simply to use him or her 
as a means, imposing significant risk of harm on him or her solely to 
benefit others.
    In the Nuremberg Code, the United States and its allies responded 
to the horrors of the Nazi war crimes by restating this principle, to 
ensure that human dignity would not again be trampled on in the pursuit 
of medical knowledge. Among other things, the Code declared: ``No 
experiment should be conducted where there is an a priori reason to 
believe that death or disabling injury will occur . . .'' \2\
---------------------------------------------------------------------------
    \2\ See ``The Nuremberg Code (1947)'' (www.cirp.org/library/ethics/
nuremberg/). The Code acknowledges one possible exception to this norm, 
which if taken absolutely would itself be problematic: ``those 
experiments where the experimental physicians also serve as subjects.'' 
Researchers have a moral responsibility to take due care of their own 
lives as well.
---------------------------------------------------------------------------
    This Code inspired many later declarations, including the 
``Declaration of Helsinki'' first approved by the World Medical 
Association in 1964. Here the key principle is:

        In medical research on human subjects, considerations related 
        to the well-being of the human subject should take precedence 
        over the interests of science and society.

    The Helsinki declaration noted that this principle must apply to 
all human beings, and that ``some research populations,'' including 
those who cannot give consent for themselves, ``need special 
protection.'' \3\ It seems this principle was intended to encompass the 
unborn, as the same organization's statement on the ethics of the 
practicing physician, the ``Declaration of Geneva,'' had the physician 
swear that ``I will maintain the utmost respect for human life, from 
the time of conception.'' \4\
---------------------------------------------------------------------------
    \3\ World Medical Association, ``Declaration of Helsinki'' 
(www.wma.net/e/policy/17-c_e.html).
    \4\ World Medical Association, ``Declaration of Geneva,'' reprinted 
in Reiser, Dyck and Curran (eds.), Ethics in Medicine (The MIT Press 
1977), at 37. In the Declaration's 1994 revision, this phrase was 
amended to ``human life from its beginning'' (www.wma.net/e/policy/17-
a_e.html).
---------------------------------------------------------------------------
    Despite these solemn declarations, American scientists and others 
dazzled by visions of technical progress have always been tempted to 
endorse a utilitarian approach to ethics, and to treat helpless or 
unpopular members of the human race as mere means to their ends.
    In the Tuskegee syphilis experiment, for example, hundreds of poor 
black sharecroppers were deliberately left with untreated syphilis for 
over twenty years to observe the course of their disease. This was no 
isolated aberration but a sustained, decades-long study conducted with 
U.S. Government support. A report filed by the Public Health Service at 
the end of the process, in 1953 (years after Nuremberg!), shows no 
trace of ethical concern--rather, the authors comment favorably on how 
subjects were encouraged to comply with the study by the offering of 
``incentives''--including the offer of free burial assistance once they 
died from their untreated syphilis! The authors concluded: ``As public 
health workers accumulate experience and skill in this type of study, 
not only should the number of such studies increase, but a maximum of 
information will be gained from the efforts expended.'' \5\
---------------------------------------------------------------------------
    \5\ Eunice Rivers et al., ``Twenty Years of Follow-Up Experience in 
a Long-Range Medical Study,'' 68 Public Health Reports 391-5 (April 
1953).
---------------------------------------------------------------------------
    There were indeed more such studies. We need only think of the 
study at Willowbrook children's home, where retarded children in the 
1960s were deliberately injected with hepatitis virus to study ways of 
preventing spread of the disease. One justification offered by the 
researchers was that hepatitis was so common in the institution that 
these children probably would have been exposed to it anyway--an 
argument we now see in the embryo research debate, when researchers 
insist that the human embryos they destroy probably would have been 
discarded anyway.\6\ Or we can look to our government's Cold War 
studies on the effects of radiation using unsuspecting military and 
civilian subjects, conducted from the 1940s to the 1970s--where the 
drive to pursue knowledge could claim additional support from the drive 
for national security.\7\
---------------------------------------------------------------------------
    \6\ See the source materials in J. Katz, Experimentation with Human 
Beings (New York: Russell Sage Foundation 1972) at 1007-8.
    \7\ See A. Skolnick, ``Advisory Committee Report Recommends That 
U.S. Make Amends for Human Radiation Experiments,'' 274 Journal of the 
American Medical Association 933 (Sept. 27, 1995).
---------------------------------------------------------------------------
    The same utilitarian approach drives those who seek to justify 
harmful experiments on human embryos today. When asked in 1994 whether 
the National Institutes of Health's Human Embryo Research Panel should 
base its conclusions on the principle that ``the end justifies the 
means,'' the Panel's chief ethicist quoted the man known as the father 
of situation ethics, Joseph Fletcher: ``If the end doesn't justify the 
means, what does?'' \8\ This ethicist later became the chief ethicist 
for Advanced Cell Technology, the Massachusetts biotechnology company 
most prominent in the effort to clone human embryos for research 
purposes. Interestingly, Fletcher himself claimed that the phrase 
originally came from Nikolai Lenin, who reportedly used it to justify 
the killing of countless men, women and children in the Russian 
revolution of 1917.\9\
---------------------------------------------------------------------------
    \8\ Ronald Green, in Transcript of the NIH Human Embryo Research 
Panel (National Institutes of Health: Rockville, MD 1994), Monday, 
April 11, 1994, at 92.
    \9\ J. Fletcher, Situation Ethics: The New Morality (Philadelphia: 
Westminster Press 1966) at 120-21.
---------------------------------------------------------------------------
    History provides us with little reason to favor utilitarian 
thinking about human life--for even judged by its own terms, making 
moral judgments solely on the basis of consequences has so often had 
terrible consequences. Because scientists, and the for-profit companies 
that increasingly support and make use of their research, are always 
tempted to treat helpless members of the human family as mere means to 
their ends, the rest of society--including government--must supply the 
urgently needed barrier against unethical exploitation of human beings.
II. The Moral Status of the Human Embryo
    Some will object that one-week-old human embryos, uniquely among 
all classes of living human organisms, deserve no such protection from 
destructive experiments. They hold that these embryos, ``according to 
science, bear as much resemblance to a human being as a goldfish.'' 
\10\
---------------------------------------------------------------------------
    \10\ Mary Tyler Moore, Testimony on behalf of the Juvenile Diabetes 
Foundation before the Senate Appropriations Subcommittee on Labor, 
Health and Human Services and Education, September 14, 2000.
---------------------------------------------------------------------------
    But this is simply scientific ignorance. Modern embryology 
textbooks tell us that the initial one-celled zygote is ``the beginning 
of a new human being,'' and define the ``embryo'' as ``the developing 
human during its early stages of development.'' \11\
---------------------------------------------------------------------------
    \11\ K. Moore and T.V.N. Persaud, The Developing Human: Clinically 
Oriented Embryology, 7th edition (Saunders: Philadelphia 2003), at 2, 
3. For similar statements from other textbooks see USCCB Secretariat 
for Pro-Life Activities, ``What is an Embryo?'', at www.usccb.org/
prolife/issues/bioethic/fact298.htm.
---------------------------------------------------------------------------
    The continuity of human development from the very beginning, and 
the reality of the early embryo as a living organism of the human 
species, has been underscored by recent biological discoveries. 
Commenting on these new findings, a major science journal concluded 
that ``developmental biologists will no longer dismiss early mammalian 
embryos as featureless bundles of cells.'' \12\ Political groups may 
still attempt to do so, of course, but they cannot claim that science 
is on their side.
---------------------------------------------------------------------------
    \12\ H. Pearson, ``Your destiny, from day one,'' 418 Nature 14-15 
(4 July 2002) at 15. For an overview of the recent findings see the 
Appendix to our June 2003 testimony to the President's Council on 
Bioethics, reprinted as R.M. Doerflinger, ``Testimony on Embryo 
Research and Related Issues,'' 3 National Catholic Bioethics Quarterly 
767-86 (Winter 2003) at 783-6.
---------------------------------------------------------------------------
    While it makes no sense to say that any of us was once a body cell, 
or a sperm, or an egg, it makes all the sense in the world to say that 
each of us was once an embryo. For the embryo is the first stage of my 
life history, the beginning of my continuous development as a human 
organism. This claim makes the same kind of sense as the claim that I 
was once a newborn infant, although I do not have any recollection of 
cognitive or specifically human ``experiences'' during that stage of 
life.
    The principle that the embryo deserves recognition and respect as a 
member of the human family is also already reflected in numerous areas 
of Federal law.\13\ At every stage of development, the unborn child in 
the womb is protected by Federal homicide laws as a separate victim 
when there is a violent attack upon his or her mother.\14\ That same 
child is recognized in Federal health regulations as an eligible 
patient deserving prenatal care.\15\ And of course, for the last eight 
years that same embryo has been protected, in much the same way as 
other human subjects, from being harmed or killed in federally funded 
research.\16\
---------------------------------------------------------------------------
    \13\ This is even generally true in the context of abortion, 
wherever Supreme Court decisions have allowed the legislative branch to 
make policy choices (as with Federal funding of abortion). In any 
event, the Supreme Court has allowed legislatures to respect unborn 
human beings and recognize them as human persons, in contexts other 
than abortion. Webster v. Reproductive Health Services, 492 U.S. 490, 
506-07 (1989). Because the human embryo in the laboratory is not 
encompassed by any reproductive liberty or ``privacy'' defined in the 
Court's abortion decisions, there is no constitutional barrier to the 
laws passed by several states against destroying embryos in the 
laboratory. The research that some members of Congress want to 
subsidize with Federal funds would be a felony in their own home 
states. See USCCB Secretariat for Pro-Life Activities, ``Current State 
Laws Against Human Embryo Research,'' www.usccb.org/prolife/issues/
bioethic/states701.htm, and ``Current State Laws on Human Cloning,'' 
www.usccb.org/prolife/issues/bioethic/statelaw.htm.
    \14\ Laci and Conner's Law, signed into law April 1, 2004 (Pub. L. 
108-212).
    \15\ Final Rule: State Children's Health Insurance Program; 
Eligibility for Prenatal Care and Other Health Services for Unborn 
Children, 67 Fed. Reg. 61956-74 (Oct. 2, 2002) at 61974 (definition of 
``child'' includes ``the period from conception to birth'').
    \16\ The version currently in effect is Section 510 of Division E 
of the Consolidated Appropriations Act of 2004 (Pub. L. 108-199).
---------------------------------------------------------------------------
    Catholic moral teaching on this issue is very clear. Every human 
life, from the first moment of existence until natural death, deserves 
our respect and protection. Human life has intrinsic dignity, not only 
a relative or instrumental value; thus every living member of the human 
species, including the human embryo, must be treated with the respect 
due to a human person.\17\ We hold further that attempts to make a 
principled argument as to why embryos need not be respected as persons 
end up excluding many other members of the human race from this status 
as well. Any mental or physical ability or characteristic (aside from 
simple membership in the human race) that one may propose as the 
deciding factor for ``personhood'' will be lacking in some people, or 
held more by some people than by others.\18\
---------------------------------------------------------------------------
    \17\ See Pope John Paul II, Evangelium vitae (The Gospel of Life) 
(1995), nos. 60-63.
    \18\ Thus human life must be respected as having intrinsic dignity 
before birth, or it will not have such dignity even after birth. This 
is recognized by many ethicists favoring human embryo research, most 
famously by Peter Singer of Princeton University. Ronald Green, cited 
above for his role in the embryo research debate, holds that there is 
nothing objective in any human being that demands our recognition of 
that human as a ``person''--rather, society may judge in given cases 
that born humans, as well, have qualities making them more valuable 
dead than alive. Ronald M. Green, ``Toward a Copernican Revolution In 
Our Thinking About Life's Beginning and Life's End,'' 66 Soundings 152 
(1983) at 159-160. If one attempts to develop and apply objective 
criteria for personhood, based for example on cognitive abilities, says 
Green, then ``it seems to be true that if the fetus is not a person, 
neither is the newborn or young infant.'' Id. at 156.
---------------------------------------------------------------------------
    Thus Catholic morality regarding respect for human life, and any 
secular ethic in agreement with its basic premises, rejects all 
deliberate involvement with the direct killing of human embryos for 
research or any other purpose. Such killing is gravely and 
intrinsically wrong, and no promised beneficial consequences can lessen 
that wrong. This conviction is also held by many American taxpayers, 
who should not be forced by government to promote with their tax 
dollars what they recognize as a direct killing of innocent human 
persons.
    But even those who do not hold the human embryo to be a full-
fledged human person can conclude that embryonic stem cell research is 
unethical. Many moral wrongs fall short of the full gravity of homicide 
but are nonetheless seriously wrong. Setting aside ``personhood,'' 
surely no one prefers funding research that requires destroying human 
life.
    Four major advisory groups recommending Federal policies on human 
embryo research over the past 23 years have agreed that the destruction 
of human life is exactly what is at stake in research that involves 
destroying human embryos. For example, the Ethics Advisory Board to the 
Department of Health, Education and Welfare concluded in 1979 that the 
early human embryo deserves ``profound respect'' as a form of 
developing human life (though not necessarily ``the full legal and 
moral rights attributed to persons'').\19\ The NIH Human Embryo 
Research Panel agreed in 1994 that ``the preimplantation human embryo 
warrants serious moral consideration as a developing form of human 
life.'' \20\ In 1999, the National Bioethics Advisory Commission (NBAC) 
cited broad agreement in our society that ``human embryos deserve 
respect as a form of human life.'' \21\ And in 2002, the National 
Academy of Sciences acknowledged that ``in medical terms,'' the embryo 
is a ``developing human from fertilization'' onwards.\22\
---------------------------------------------------------------------------
    \19\ ``Report of the Ethics Advisory Board,'' 44 Fed. Reg. 35033-58 
(June 18, 1979) at 35056.
    \20\ National Institutes of Health (NIH), Report of the Human 
Embryo Research Panel (September 1994), at 2.
    \21\ National Bioethics Advisory Commission (NBAC), Ethical Issues 
in Human Stem Cell Research (Rockville, Maryland: September 1999), Vol. 
I at ii; cf. 2.
    \22\ National Academy of Sciences (NAS), Scientific and Medical 
Aspects of Human Reproductive Cloning (National Academy Press 2002), 
262.
---------------------------------------------------------------------------
    What does this respect mean, if it does not mean full and active 
protection from harm of the kind we extend to human persons? At a 
minimum, doesn't it mean that we will not use public funds to promote 
such harm? It is absurd to treat a human life solely as a source of 
spare parts for other people, and claim that this demonstrates your 
``respect'' for that life. It is equally absurd to fund stem cell 
research that encourages researchers to destroy human embryos for their 
cells, and claim that one is not promoting disrespect for the lives of 
those embryos.\23\
---------------------------------------------------------------------------
    \23\ Says ethicist Glenn McGee, who supports embryo research: 
``Pretending that the scientists who do stem cell research are in no 
way complicit in the destruction of embryos is just wrong, a smoke and 
mirrors game on the part of the NIH. It would be much better to take 
the issue on directly by making the argument that destroying embryos in 
this way is morally justified--is, in effect, a just sacrifice to 
make.'' Quoted in J. Spanogle, ``Transforming Life,'' The Baylor Line 
(Winter 2000) at 30.
---------------------------------------------------------------------------
    It does not help this argument to claim that the only embryos to be 
destroyed for research are those who ``would have been discarded 
anyway.'' The mere fact that some parents discard ``excess'' embryos 
creates no argument that the Federal government should intervene to 
assist in their destruction--any more than the fact that many abortions 
are performed in the U.S. creates an argument that Congress must use 
its funding power to promote such killing. In fact, Congress has for 
many years rejected arguments that it can fund harmful experiments on 
unborn children slated for abortion because ``they will die soon 
anyway.'' See 42 U.S.C. Sec. 289g. The claim that humans who may soon 
die automatically become fodder for lethal experiments also has ominous 
implications for condemned prisoners and terminally ill patients. In 
the final analysis, all of us will die anyway, but that gives no one a 
right to kill us.
    Even on its own amoral terms, that argument also misunderstands the 
informed consent process for ``disposition'' of frozen embryos in U.S. 
fertility clinics. When these clinics produce more embryos in a given 
cycle than parents need for their immediate reproductive goals, they do 
indeed freeze the ``excess'' embryos and ask the parents what should be 
done with them after a given time. Most clinics offer the options of 
continuing to preserve the embryos, using them for further reproductive 
efforts by the couple, donating them to another couple for 
reproduction, discarding them, or donating them for research. But these 
are mutually exclusive options. For example, it would violate the 
professional code of the fertility industry to take embryos ``to be 
discarded'' and use them for research instead. And among embryos 
donated for research, no researcher or government official can tell 
which embryos ``would have been discarded'' if this option had not been 
offered.\24\
---------------------------------------------------------------------------
    \24\ In its 1999 report, NBAC recommended that clinics first offer 
parents the option of having their embryonic children destroyed, and 
only then offer a choice between discarding and destructive research as 
the two ways of destroying them. NBAC, note 21 supra at 53. Such a 
policy might provide a factual basis for determining that embryos 
slated for research would have been destroyed anyway. But as far as 
anyone can determine, no fertility clinic has taken this approach. The 
number of frozen embryos in the United States now designated for 
research, that one can determine would only have been ``discarded 
anyway,'' is zero.
---------------------------------------------------------------------------
    The problem with past Federal advisory panels is that they have 
generally failed to give any real content to the notion of ``respect'' 
or ``serious moral consideration'' for the embryonic human. The NIH 
Human Embryo Research Panel failed miserably in this task. Since the 
Panel approved a wide array of lethal experiments on human embryos--
including some which required specially creating embryos solely to 
destroy them--even the Panel's own members publicly observed that it 
had come to use the word ``respect'' merely as a ``slogan'' with no 
moral force.\25\
---------------------------------------------------------------------------
    \25\ Transcript, note 8 supra, April 11, 1994, at 40 (remarks by 
Dr. Bernard Lo).
---------------------------------------------------------------------------
    In the end, the Panel's report was rejected in part by President 
Clinton (who denied funding for experiments involving the creation of 
embryos for research), and rejected in its entirety by Congress (which 
enacted the appropriations rider against funding harmful embryo 
research that remains in law to this day).
    Five years later, the National Bioethics Advisory Commission tried 
to give more definition to what ``respect'' for the embryo might mean 
in the research context:

        In our judgment, the derivation of stem cells from embryos 
        remaining following infertility treatments is justifiable only 
        if no less morally problematic alternatives are available for 
        advancing the research.\26\
---------------------------------------------------------------------------
    \26\ NBAC, note 21 supra, at 53.

    While this standard does not fully respect the embryo as a person 
with inviolable rights, it creates a presumption against research that 
requires killing embryos: Such research was to be a last resort, 
pursued only after it is found that research benefits cannot be pursued 
in any other way. However, the Commission then evaded the implications 
of this standard, by ignoring the emerging evidence about the promise 
of adult stem cells and other alternatives. But the Commission admitted 
that its factual claim on this point must be reevaluated as scientific 
knowledge advanced.
    As the National Institutes of Health acknowledged in 2001, the 
burden of proof needed to justify human embryo research by NBAC's 
ethical standard has never been met. The NIH's review of stem cell 
research concluded that any therapies based on embryonic stem cells 
were ``hypothetical and highly experimental,'' and that it could not be 
determined at that time whether these cells would have any advantages 
over the less morally problematic alternatives.\27\
---------------------------------------------------------------------------
    \27\ NIH, Stem Cells: Scientific Progress and Future Research 
Directions (Dept. of Health and Human Services, June 2001), at 17; also 
see 63 (any possible advantages of embryonic cells remain to be 
determined), 102 (not known whether these cells are better suited for 
gene therapy).
---------------------------------------------------------------------------
    Since that time, in fact, scientific and practical barriers to the 
medical use of embryonic stem cells have loomed larger than many 
scientists expected in 1999. Problems of tumor formation, 
uncontrollability, and genetic instability are now cited among the 
reasons why embryonic stem cells cannot safely be used in human trials 
any time in the foreseeable future.\28\ At the same time, non-embryonic 
stem cells have moved quickly into promising clinical trials for a wide 
array of conditions, including spinal cord injury, multiple sclerosis, 
Parkinson's disease, heart damage and corneal damage.\29\
---------------------------------------------------------------------------
    \28\ See the sources cited in USCCB Secretariat for Pro-Life 
Activities, ``Practical Problems with Embryonic Stem Cells,'' 
www.usccb.org/prolife/issues/bioethic/stemcell/obstacles51004.htm.
    \29\ See: the sources cited in USCCB Secretariat for Pro-Life 
Activities, ``Scientific Experts Agree: Embryonic Stem Cells are 
Unnecessary for Medical Progress,'' www.usccb.org/prolife/issues/
bioethic/fact401.htm; Testimony of Susan Fajt, Laura Dominguez, and 
Dennis Turner before this Subcommittee, July 14, 2004, at 
www.stemcellresearch.org/testimony/index.html; and the constantly 
updated reports of therapeutic advances at www.stemcellresearch.org.
---------------------------------------------------------------------------
    Many researchers and biotechnology companies have responded to this 
evidence by simply abandoning NBAC's standard. In short, they are 
losing the game and have decided to move the goalpost.
    What is now often heard is that research using both embryonic and 
non-embryonic stem cells must be fully funded now, to determine which 
source is best for various functions. In other words, we must help 
researchers violate NBAC's ethical standard now, to determine whether 
they will ever be able to meet the burden of proof that standard places 
on them.
    But this approach simply reduces ``respect'' for the embryo to 
nothing at all. For that is the approach one would take if there were 
no moral problem whatever--if the only factor determining our research 
priorities were relative efficiency at achieving certain goals. 
``Respect'' must mean, at a minimum, that we are willing to give up 
some ease and efficiency in order to obey important moral norms instead 
of transgressing them.
    At this point, it is not even established that continued pursuit of 
embryonic stem cell research would increase the ease and efficiency of 
arriving at any treatments, for it may only divert attention and 
resources away from alternative approaches that could cure diseases 
more quickly.
    In short, using Federal funds to encourage the destruction of 
embryos for new stem cell lines not only fails the test of a principled 
``sanctity of life'' ethic. Given the lack of clear evidence for any 
unique or irreplaceable role for embryonic stem cells in the treatment 
of devastating diseases, it even fails the test offered by proponents 
of human embryo research when they advised the Federal government on 
this issue five years ago.
III. The Reality of an Ethical Slippery Slope
    The campaign for expanded Federal support for embryonic stem cell 
research also ignores the fact that its goal cannot be achieved without 
violating even more ethical norms. Any agenda that will inevitably 
require such further violations in order to produce any of its promised 
results must be held accountable now for justifying those violations. 
Otherwise our government could waste years of effort and millions of 
dollars on an approach that must be abandoned in midstream, before 
producing results--with devastating consequences for patients now 
awaiting treatments.
    At present, contrary to many misleading comments in the political 
debate, there are no set limits on the amount of Federal funding that 
may be allocated for embryonic stem cell research. However, current 
policy is to fund only research using the embryonic stem cells obtained 
by destroying human embryos prior to August 9, 2001. These cell lines 
are intended to be adequate only for basic research, to determine 
whether embryonic stem cells offer uniquely promising benefits without 
encouraging the destruction of live embryos to obtain the cells for 
that project.
    Some claim the currently eligible cell lines are inadequate in 
number and ``contaminated'' by the mouse feeder cells used to culture 
them. They argue that new cell lines like those recently created with 
private funds by Harvard researchers, and the ``more than 400,000 IVF 
embryos'' now frozen that could be used for research, must not be 
allowed to go to waste. The implied argument is that if only these 
additional cell lines, and currently existing ``excess'' embryos, were 
offered up for federally funded research, researchers would have all 
they need to cure terrible diseases.
    But even if embryonic stem cells could ever be used to cure serious 
illnesses--which at this point is hypothetical--this argument makes no 
sense. It is important to understand why.
    First, it has not been shown that the cell lines already eligible 
for funding are inadequate for their intended task--conducting basic 
research in the advantages and disadvantages of these cells. Because 
some of the cells were frozen for later use immediately after being 
harvested from embryos, the number of actual cell lines continues to 
grow as the cells are thawed and cultured. For example, there were 15 
lines when House members wrote to President Bush urging an expanded 
policy this summer, and 19 by the time the Senate letter was circulated 
a few weeks later. According to the NIH, over 400 derivatives of these 
lines have been shipped to researchers as of February 2004. Some cells 
remain frozen at this point (and so could be cultured without the 
``contamination'' of animal feeder cells if necessary), while over two 
dozen eligible cell lines are currently unavailable to federally funded 
researchers only because their owners have not yet agreed to share them 
with other researchers.\30\
---------------------------------------------------------------------------
    \30\ See A. Robeznieks, ``The politics of progress: How to continue 
stem cell research despite limitations,'' American Medical News, August 
9, 2004, www.ama-assn.org/amednews/2004/08/09/prsa0809.htm#s1.
---------------------------------------------------------------------------
    Second, the new Harvard cell lines have the same deficiencies as 
the currently eligible cell lines. They are inadequate for any 
significant clinical use, they were cultured in mouse feeder cells, 
and--most interesting of all--they have already developed serious 
genetic ``abnormalities'' in culture.\31\ A recent study suggests that 
all human ESC lines may spontaneously accumulate extra chromosomes that 
are typical of human embryonal carcinoma cells from testicular 
cancer.\32\
---------------------------------------------------------------------------
    \31\ The abnormal cells have a ``proliferative advantage'' over the 
remaining normal cells in the culture, suggesting that these cell lines 
may soon consist largely of abnormal cells. C. Cowan et al., 
``Derivation of Embryonic Stem Cell Lines from Human Blastocysts,'' 
350(13) New England Journal of Medicine 1353-6 (March 25, 2004) at 
1355.
    \32\ J. Draper et al., ``Recurrent gain of chromosomes 17q and 12 
in cultured human embryonic stem cells,'' 22 Nature Biotechnology 53-4 
(2003).
---------------------------------------------------------------------------
    Third, the Rand study which concluded that there may be as many as 
400,000 frozen embryos in the United States also found that only 11,000 
(less than 3 percent of the total) are designated by parents for 
possible use in research. If all these 11,000 frozen embryos were 
destroyed for their stem cells (seen by the authors as a ``highly 
unlikely''scenario), this may produce a grand total of 275 cell lines--
surely inadequate for use in treating any major disease.\33\
---------------------------------------------------------------------------
    \33\ D. Hoffman et al., ``Cryopreserved embryos in the United 
States and their availability for research,'' in 79 Fertility and 
Sterility 1063-9 (2003) at 1068.
---------------------------------------------------------------------------
    Last year an opinion piece attacking President Bush's policy cited 
two prominent researchers in support of the claim that merely 
determining the ``best options for research'' (to say nothing of 
clinical use) would require ``perhaps 1,000'' stem cell lines--about 
four times as many as those which could be obtained by destroying every 
available human embryo in frozen storage nationwide.\34\ Another group 
of researchers has concluded that in order to reflect the genetic and 
ethnic diversity of the American population, an embryonic stem cell 
bank geared toward treating any major disease would have to include 
cell lines from many embryos created solely in order to be destroyed 
for those cells--including a disproportionate number of specially 
created embryos conceived by black couples and other racial minorities, 
who are underrepresented among current fertility clinic clients.\35\ 
Yet another prominent stem cell researcher estimated that unless 
researchers resort to human cloning to produce genetically matched stem 
cells for each patient, ``millions'' of embryos from fertility clinics 
may be needed to create cell lines of sufficient genetic diversity for 
clinical use.\36\
---------------------------------------------------------------------------
    \34\ S. Hall, ``Bush's Political Science,'' in The New York Times, 
June 12, 2003, A33.
    \35\ R. Faden et al., ``Public Stem Cell Banks: Considerations of 
Justice in Stem Cell Research and Therapy,'' in Hastings Center Report, 
November-December 2003, 13-27.
    \36\ R. Lanza and N. Rosenthal, ``The Stem Cell Challenge,'' 
Scientific American (May 2004), 93-99 at 94. Another study, while 
noting that other solutions to the immune rejection problem might be 
found, agrees that the creation of a sufficiently diverse bank of 
embryonic stem cell lines is ``almost impossible.'' M. Drukker and N. 
Benvenisty, ``The immunogenicity of human embryonic stem-derived 
cells,'' 22(3) TRENDS in Biotechnology 136-141 (March 2004) at 138.
---------------------------------------------------------------------------
    Of course, trying to address this problem with cloning would 
require specially creating and then destroying many millions of embryos 
as well--an estimated hundred embryos per individual patient, 
potentially requiring the exploitation of many millions of women for 
their eggs to treat even one major disease.\37\ Undaunted, the national 
Biotechnology Industry Organization (BIO), in a statement echoed by 
many researchers, has testified that the use in humans of the cloning 
technique that created Dolly the sheep will be ``essential'' to 
realizing the promise of embryonic stem cell research.\38\
---------------------------------------------------------------------------
    \37\ ``Optimistically, 100 human oocytes would be required to 
generate customized ntES cell [nuclear transfer embryonic stem cell] 
lines for a single individual . . . human oocytes must be harvested 
from superovulated volunteers, who are reimbursed for their 
participation. Add to this the complexity of the clinical procedure, 
and the cost of a human oocyte is $1,000-2,000 in the U.S. Thus, to 
generate a set of customized ntES cell lines for an individual, the 
budget for the human oocyte material alone would be--$100,000-200,000. 
This is a prohibitively high sum that will impede the widespread 
application of this technology in its present form.'' P. Mombaerts, 
``Therapeutic cloning in the mouse,'' 100 Proceedings of the National 
Academy of Sciences 11924-5 (September 30, 2003) at 11925.
    \38\ ``Somatic cell nuclear transfer research is essential if we 
are to achieve our goals in regenerative medicine.'' Testimony of 
Thomas Okarma on behalf of BIO before the House Energy and Commerce 
Subcommittee on Health, June 20, 2001, http://energycommerce.house.gov/
107/hearings/06202001Hearing291/Okarma450.htm. During the question 
session Dr. Okarma made it clear he meant the use of this technology to 
create genetically tailored human embryos for research, including stem 
cell research.
---------------------------------------------------------------------------
    BIO's testimony on this point should help to clarify our minds, for 
it may be rephrased as follows: Unless you are willing to commit 
yourself in the future to human cloning and the mass-production of 
human lives in order to exploit and destroy them, there is no point in 
promoting federally funded research using so-called ``excess'' embryos 
now.
    And there is yet another moral line to cross beyond this. For the 
effort to use human embryo cloning for ``therapeutic'' purposes 
involves all the practical barriers inherent in embryonic stem cell 
research in general, plus some additional problems. For example, even 
cloned embryos with a normal genetic makeup generally suffer from 
chaotic gene expression, leading to many embryonic and fetal deaths and 
to increased risks in using any cells from these embryos for future 
therapies. There is evidence that there may be a later opportunity in 
fetal development to correct these gene expression problems, if the 
embryo can survive to that point.\39\
---------------------------------------------------------------------------
    \39\ J. Fulka et al., ``Do cloned mammals skip a reprogramming 
step?'', 22(1) Nature Biotechnology 25-6 (January 2004).
---------------------------------------------------------------------------
    Perhaps due partly to this phenomenon, the major studies seeking to 
provide an animal model for ``therapeutic'' cloning have found it 
necessary to implant the cloned embryo in a womb and develop it past 
the embryonic stage to obtain usable cells and tissues.\40\ Thus the 
old alleged distinction between ``reproductive'' cloning (placing 
cloned embryos in a womb for gestation) and ``therapeutic'' cloning 
(destroying cloned embryos for research purposes) is breaking down, as 
the former increasingly becomes a necessary component of the latter.
---------------------------------------------------------------------------
    \40\ In the first study, mice derived from cloning had to be 
brought to live birth to harvest their adult bone marrow stem cells. W. 
Rideout III et al., ``Correction of a Genetic Defect by Nuclear 
Transplantation and Combined Cell and Gene Therapy,'' 109 Cell (April 
5, 2002), 17-27. For a critique see Americans to Ban Cloning, ``Why the 
`Successful' Mouse `Therapeutic' Cloning Really Didn't Work,'' 
www.cloninginformation.org/info/unsuccessful_mouse_therapy.htm. A 
second study required placing cloned cow embryos in wombs to develop 
them to the fetal stage, then aborting them for their kidney tissue. R. 
Lanza et al., ``Generation of histocompatible tissues using nuclear 
transplantation,'' 20(7) Nature Biotechnology 689-696 (July 2002). The 
authors wrote: ``Because the cloned cells were derived from early-stage 
fetuses, this approach is not an example of therapeutic cloning and 
would not be undertaken in humans.'' Id. at 689. But these same authors 
published a new study this year, in which cloned mouse embryos had to 
be developed to 11 to 13 days of gestation (the equivalent of the fifth 
to sixth month in humans) and then aborted to obtain usable cardiac 
cells. R. Lanza et al., ``Regeneration of the Infarcted Heart With Stem 
Cells Derived by Nuclear Transplantation,'' 94 Circulation Research 
820-7 (April 2, 2004). This time there were no disclaimers. Instead the 
lead author declared that this is ``an important new paradigm'' for 
human ``therapeutic cloning.'' See Advanced Cell Technology, ``Cloned 
Stem Cells Regenerate Heart Muscle Following a Heart Attack,'' February 
10, 2004, http://salesandmarketingnetwork.com/
news_release.php?ID=14109&key=
Advanced%20Cell%20Technology.
---------------------------------------------------------------------------
    BIO has already acted to provide legislative authorization for this 
approach in humans--by supporting state laws to allow researchers to 
clone human embryos and develop them in wombs into the last stages of 
fetal development, as long as they do not allow a full-term live 
birth.\41\ One such law has already been enacted, in New Jersey.\42\ 
And the pending California ballot initiative known as Proposition 71, 
which would force the financially strapped state government to borrow 
$3 billion to fund embryonic stem cell and human cloning research, 
would ``initially'' forbid developing cloned human embryos past 12 
days--but allow indefinite expansion of this limit, by vote of a new 
Oversight Committee dominated by stem cell advocates.\43\
---------------------------------------------------------------------------
    \41\ See Americans to Ban Cloning, ``Report: State Bills on Human 
Cloning,'' March 26, 2003, www.cloninginformation.org/info/ABC-State-
Laws.htm.
    \42\ See: W. Smith, ``Cloning in New Jersey,'' in The Daily 
Standard (online service of The Weekly Standard), December 11, 2003, 
www.weeklystandard.com/Content/Public/Articles/000/000/003/
482iusla.asp; News Article, ``A safe haven for human cloning?'', The 
Monitor (Newspaper of the Diocese of Trenton, NJ), December 19, 2003, 
http://www.dioceseoftrenton.org/department/news_detail.asp?newsid=850.
    \43\ See ``California Stem Cell Research and Cures Act,'' Website 
of the Attorney General of California, http://www.caag.state.ca.us/
initiatives/pdf/sa2003rf0055amdt1_ns.pdf. The ``initial'' time limit on 
the age of embryos to be destroyed for their stem cells (8 to 12 days) 
can be changed by the Oversight Committee (Id. at 11), whose 
chairperson must have a ``documented history in successful stem cell 
research advocacy'' (Id. at 6). The initiative places a ``high 
priority'' on stem cell research not eligible for Federal funding, 
ensuring that the funds will be used primarily for embryonic stem cell 
and human cloning research (Id. at 16).
---------------------------------------------------------------------------
    In short, no new breakthroughs have shown that embryonic stem cells 
are ready or almost ready for clinical use. Use of new cell lines from 
frozen embryos has not been shown to be necessary for current basic 
research, and would still be completely inadequate for any large-scale 
clinical research--suggesting that proposals for expanding the current 
embryonic stem cell policy are themselves only a transitional step 
toward mass-producing embryos (by cloning or other means) solely for 
harmful experimentation. The for-profit biotechnology industry has 
known this for years, and has begun paving the legislative road toward 
large-scale human cloning and ``fetus farming'' in case these prove 
necessary for technical progress in this field.
Conclusion
    Since human embryonic stem cells were isolated and cultured in 
1998, initial hyped promises of miracle cures for devastating diseases 
have collided with reality. More than two decades of research using 
mouse embryonic stem cells have produced no treatments in mice that are 
safe or effective enough for anyone to propose in humans. These cells 
have not helped a single human being, and the practical barriers to 
their safe and effective use loom larger than ever. Meanwhile, 
alternative approaches that harm no human being have moved forward to 
offer realistic hope for patients who many said could be helped only by 
research that destroys human embryos. Campaigns for increased public 
funding have grown in inverse proportion to the dwindling hopes of 
medical benefit, as private funding sources increasingly realize that 
embryonic stem cell research may not be a wise investment.
    We should not succumb to this latest campaign, but reflect on the 
ethical errors that brought us this far. Even proponents of the 
research have admitted that it poses an ethical problem, because it 
involves destroying human lives deserving our respect. Based in part on 
the actions and statements of proponents, we can see that still further 
ethical breaches will be required of Congress and society to realize 
the ``promise'' of this approach. Already the policy debate has moved 
from ``spare'' embryos in fertility clinics, to specially creating 
embryos for destruction, to mass production of embryos through cloning, 
to the gestation of these embryos for ``fetus farming'' and the 
harvesting of body parts.
    Congress should take stock now and realize that the promise of this 
approach is too speculative, and the cost too high. That cost includes 
the early human lives destroyed now and in the future, the required 
exploitation of women for their eggs and perhaps for their wombs, and 
the diversion of finite public resources away from research avenues 
that offer real reasons for hope for patients with terrible diseases. 
Let's agree to support avenues to medical progress that we can all live 
with.

    Senator Brownback. Thank you very much.
    That was excellent testimony presented by both of you. We 
have a few minutes left in this vote. We're going to go vote on 
this one. And there is supposed to be a second vote, and we 
will vote at the front end of that and then come back and 
consume--we'll move forward with questions on this panel.
    So we will be in recess until we are able to return, 
hopefully in about 15 minutes.
    [Recess.]
    Senator Brownback. I call the hearing back to order. I'm 
sorry it took us so long. I think we will have other Members 
that will be joining us. Let's run the time clock at 7 minutes 
so we can bounce this back and forth.
    Thank you all for staying here and being with us.
    Dr. Zoloth, I read your testimony last night, and I 
appreciate it, I appreciate the thoughtfulness of it. And I 
don't always get testimony read, so I wanted to make sure to 
look through it and to inquire of you about it. And you talk 
about the nature of, you know, the very ethical decision of, 
When does life begin? And you look at this and say, ``Well, I 
don't think this qualifies to it.'' And, as I understand it, 
it's the issue of not being in the womb. Is that the issue of 
how you determine that this is not human life?
    Dr. Zoloth. It's two different things. It's both the fact 
that the kind of blastocysts we're talking about are always 
created artificially, never inside of a woman's womb, and 
they're taken and used for stem cell research before the time 
that they would, even if they were part of a normal pregnancy 
cycle, be considered a human life for the legal requirements of 
Judaism. Because, for Jews, human life begins--and it's 
assessed developmentally--and the first 40 days of a pregnancy 
are a time of a lesser moral status, and the pregnancy really 
begins when it takes shape and form at the 40th day. This 
tradition----
    Senator Brownback. So it's after 40--I just want to get 
to----
    Dr. Zoloth. Forty days.
    Senator Brownback.--this----
    Dr. Zoloth. It's actually the tradition----
    Senator Brownback.--after 40 days.
    Dr. Zoloth. After 40 days. Now, the interesting thing is, 
that's true not only for Jews, but for Muslims and for a long 
Aristotelian tradition of an unformed fetus; in fact, as our 
colleagues in the Catholic Church could tell us, until 1859, 
for many in the Catholic Church, and many who interpreted Canon 
law, as well. So this uncertainty about when human life begins, 
it's a very old, deeply understood as a religious 
consideration.
    Senator Brownback. Let me take a point, then, on that. The 
Democrat Presidential nominee believes life begins at 
conception. That's what he's stated recently. And that is at 
the very heart of what we're talking about here, is, when does 
that life begin? In your own existence, in your own case--you--
when did your life begin?
    Dr. Zoloth. That's a complicated question. My life begins 
in--obviously, there's an event that takes place when I, 
myself, comes into existence in terms of my DNA. If you're just 
looking at when my DNA begins to exist, obviously, at the 
moment of fertilization. But as a religious Jew, I believe that 
human life is a developmental process. You acquire moral status 
as you acquire more and more milestones on this developmental 
path. And as a religious Jew, my duties and obligations began, 
for me, in the classically, religiously understood terms, at 
the moment that I was born into the world and capable of being 
received as a person in my religious community. People have, 
then, duties to me, and I would grow in my duties to them.
    Senator Brownback. Well, let me ask you, biologically, when 
did your life begin?
    Dr. Zoloth. Well, no one can really know that answer, 
because it's not a fixed biological question. Maybe it's when 
the first noggin gene turned on or when my cells began to 
organize or when the first neuron begins to assert itself.
    Senator Brownback. When do you believe your life began, 
biologically?
    Dr. Zoloth. Biologically? I believe--I think about these 
things in terms of my faith's tradition and my----
    Senator Brownback. Biologically----
    Dr. Zoloth.--biologically, I think my life begins as a 
DNA'd organism. Right? When my DNA begins to assert itself. But 
it's not an important----
    Senator Brownback. That would be the moment----
    Dr. Zoloth.--point.
    Senator Brownback.--of conception, is that correct?
    Dr. Zoloth. But that--but what moment is that, really? What 
moment is that? Maybe it's when I'm organized. I think that's 
an infinitely complex biological question, and I am--I'm not a 
biologist; I'm a religious Jew, so my life begins as an entity 
perhaps when I'm capable of living independent from my mother's 
body.
    Now, I used to be a neonatal intensive-care nurse----
    Senator Brownback. Right.
    Dr. Zoloth.--so I'm aware of how differently--before I was 
a philosopher--I'm aware of how differently embryos come to 
change and grow, and the success by which they do or don't live 
outside of a woman's body. And that, too, is the developmental 
process.
    Senator Brownback. Let me ask you this, then. When did the 
life of your son begin? You were talking about the paper he's 
writing. When did, biologically, his life begin?
    Dr. Zoloth. Well, we're going to keep going back around and 
around that, and I think that's the question that as I'm----
    Senator Brownback. That's what we're trying to get at.
    Dr. Zoloth. But I don't think it's a biological answer. For 
me--I don't think it's an--I don't think it's an--for me, it's 
not the salient point, ``When does it biologically begin?'' I 
could be convinced that--by a number of different arguments, 
but the most important one is that it's a biological process 
that doesn't have a moment of divinity or a moment of 
conception that is of biological importance to me. Many----
    Senator Brownback. OK----
    Dr. Zoloth.--many genes have to work as a system. The 
system has to be successful. There are a number of different 
milestones before I can truly say I've biologically begun a 
process that will be successful.
    Senator Brownback. So then--but you advocate we should 
experiment on humans at these very early stages of development. 
Indeed, you would we are required to do this, justice requires 
this. But if we researched on me at 2 days of age, or you at 2 
days biological age, or your son at 2 days biological age, 
would that have been appropriate?
    Dr. Zoloth. This isn't about my son or myself, human 
persons at different stages within a woman's body. We're 
talking about blastocysts at the 3-day-age stage----
    Senator Brownback. OK, then----
    Dr. Zoloth.--created outside of a womb.
    Senator Brownback.--blastocysts----
    Dr. Zoloth. And I think of that--blastocysts, I would--I do 
believe, religiously and morally, are warranted. And, in fact, 
we have an imperative to research on these clusters of cells if 
we believe--have come to believe that they can yield cures.
    Senator Brownback. What would have happened had we 
experimented on you at the blastocyst stage?
    Dr. Zoloth. Well, that's an obvious question. If I was--
it's an odd theoretical one--if I could somehow be----
    Senator Brownback. It's not a theoretical. I'm just----
    Dr. Zoloth. If I could have been taken out----
    Senator Brownback.--asking biologically.
    Dr. Zoloth.--if I could have been taken out of my mother's 
womb, which is--which is different----
    Senator Brownback. What----
    Dr. Zoloth.--from our situation, then I wouldn't have----
    Senator Brownback. What would have happened to you?
    Dr. Zoloth. I wouldn't have existed, obviously. But this 
same token is, I'm going to be, for instance--as our colleague 
pointed out, I'm going to be, inevitably, dead; but I'm not now 
treated as though I'm dead now. I'm treated as though I'm a 
living philosopher, not as a dead one. And so we take account 
of different moments in our biological process.
    Senator Brownback. Do you support human cloning?
    Dr. Zoloth. Under some limited circumstances, with a number 
of restraints, never for reproduction--never for reproduction--
or implantation in the human womb. I do, for experimental 
purposes to do basic research, yes.
    Senator Brownback. Mr. Doerflinger, when did your life 
begin, biologically?
    Mr. Doerflinger. Biologically? I think there are two 
different questions that we shouldn't confuse. One is a 
biological question. And in the embryology textbooks--there are 
sources cited in my testimony--say that the first one-celled 
embryo is ``the beginning of a new human being.'' A simple 
biological fact. This is a new member, an individual member, of 
the species; therefore, a human being, in that sense. That's 
when I started, that's when everybody, as far as I know, 
started.
    Now, the moral question, it seems to me, is what moral 
value we attribute to different stages of that process. Now, 
it's our conviction in the Catholic Church that unless you see 
every stage of that process as having inherent worth simply 
because this is a member of the human race, you end up with a 
theory in which nobody really has inherent rights; everybody 
has different moral value attributed to them based on the 
traits or the abilities, the mental and physical abilities, 
they have at any given time. You can acquire personhood, you 
can lose personhood when you're near the end of your life and 
get into a coma or have Alzheimer's, because you don't have any 
cognitive processes, maybe, going on then either. And we feel 
that's a very risky logical argument that would endanger a lot 
of helpless human beings.
    But the Catholic Church never held that, as a matter of 
religion, life begins at 40 days. What we've always said is 
that--here's where we were doing a lot better than we did with 
astronomy in the Galileo case----
    Dr. Zoloth. That's not hard.
    Mr. Doerflinger.--we have to respect life whenever the 
biologists tell us it's there. And the biologists, until the 
19th century, were very confused about those early stages, 
because they didn't know about the process of conception. They 
thought that the form for the new human being was entirely 
located in the male sperm, and they had to figure out some kind 
of intermediate stages for how that sperm can turn into someone 
who is specifically human and somehow even has traits from the 
mother. And in 1825, the ovum was discovered, the process of 
conception discovered, and, at that point, the church 
acknowledged that this, then, should be the beginning for moral 
respect, as well.
    Senator Brownback. Senator Wyden, I'll bet you never 
thought you'd get this sort of education, did you?
    Senator Wyden. That's for sure. And I'm going to ask a 
couple of questions to start with, for you, Dr. Doerflinger, 
that I'd really like just a yes or no answer to, because this 
is a complicated field, and it's one where sometimes the more 
you learn, the less you know.
    And let me start by asking you about fertility clinics. I 
think you know that I wrote the only Federal law that's on the 
books now with respect to fertility clinics. It at least 
provides some measure of oversight and consumer protection for 
the millions of couples that look to them. And my question that 
I'd like a yes or no answer to is, Do you support the in vitro 
process that is used at fertility clinics around the country?
    Mr. Doerflinger. You mean morally?
    Senator Wyden. No, I just want to know, yes or no, do you--
--
    Mr. Doerflinger. No.
    Senator Wyden.--support it. You do not.
    Mr. Doerflinger. Right.
    Senator Wyden. If you had your way, then because of your 
answer millions of couples wouldn't have the opportunity to 
have what they want more than anything else. And your----
    Mr. Doerflinger. No.
    Senator Wyden.--candor is appreciated on it, but----
    Mr. Doerflinger. No, that's--no, I think that's a false 
statement.
    Senator Wyden. Well, how would they? I mean, that's the 
process that is used at fertility clinics, and you've said you 
don't favor----
    Mr. Doerflinger. Well----
    Senator Wyden.--using that process.
    Mr. Doerflinger.--that's one process that actually has a 
success rate that's far below a lot of other things that I have 
a lot less moral problem with.
    Senator Wyden. Well, that----
    Mr. Doerflinger. I thought it was a question, so I 
answered.
    Senator Wyden. Well, but that--and I appreciate that. And 
that's what my legislation does, of course, is make it possible 
for people to compare success rates. But you said you don't 
favor a process that has provided incredible happiness to 
millions of couples, and you've answered my question clearly.
    The reason I asked is, I wanted to lay the foundation for 
the second question, and that is--as you know, at fertility 
clinics, there are often embryos that aren't used. What do you 
favor being done with those embryos that are not used?
    Mr. Doerflinger. I think I'd have to be favoring the 
process in order to be in the position to--obviously, I don't 
want them to be happening at all.
    Senator Wyden. Yes. So you're----
    Mr. Doerflinger. I think you'd have to ask that question of 
someone who supports it.
    Senator Wyden. Yes, I appreciate your answer. I mean, I 
thought that you would be supportive of the process, and I was 
going to ask you some questions about whether they ought to be 
donated or the like. But you've answered, and I appreciate the 
answer.
    My second question for you is, Do you think the country is 
better off funding embryonic stem cell research on the Federal 
level so that we could have one tough set of Federal ethical 
guidelines, rather than what I have described as this kind of 
crazy quilt of policy and state regulation? I think you were 
here when I gave my opening statement, and one of the concerns 
that I have is--because our citizens are so frustrated now 
about the inaction of the Federal Government--is, they're just, 
kind of, going off and doing their own thing. And so New Jersey 
is going to do theirs, and Harvard's going to have a program, 
and California's going to have a program. And what will 
happen--and Senator Brownback--because he and I have sat 
through hours of these hearings--makes a very good case that we 
need a good set of ethical guidelines. This is not something I 
want to see done without ethical guidelines, but I think we 
ought to have one clear, strong set of Federal guidelines, 
rather than what we're going to have now, which is a sort of 
hodgepodge and crazy quilt. Do you think that we ought to have 
one set of guidelines?
    Mr. Doerflinger. I think we have one set of Federal 
guidelines now, Senator.
    Senator Wyden. We do----
    Mr. Doerflinger. Except that----
    Senator Wyden.--but that's going to change once the 
California ballot measure passes.
    Mr. Doerflinger. Oh, no, I----
    Senator Wyden. It will.
    Mr. Doerflinger. Now I understand your question.
    Senator Wyden. Yes.
    Mr. Doerflinger. No, no, the--you could expand the Federal 
guidelines all you want, and there would still be a crazy quilt 
on what's funded by the states. Deciding that you're going to 
set limits or expand the limits on federally funded research 
doesn't change anything, one way or the other, as to privately 
or state-funded research. In fact, the California initiative 
says that it's their top priority to fund only embryonic stem 
cell and cloning research that is not funded by the Federal 
Government. So, for example, if you put these tough Federal 
guidelines in, and you say, ``But we're only going to fund 
research on the spare embryos,'' that means all $3 billion of 
the California money might go into cloning. So it's not a 
restraint--unless you were to say, ``The Federal policy is 
going to reach out and cover all privately and state-funded 
research, at all,'' which hasn't been done on any research, 
including research on adults, since the beginning of Federal 
regulations.
    Senator Wyden. Dr. Zoloth, do you want to answer that 
question, as well? Would we be better off with one standard?
    Dr. Zoloth. Like I said, I've traveled to other countries 
to see how they do it, because I think it's an interesting 
question, and the most well-established principle is the one 
Britain. And, in fact, it does cover both public and private 
sorts of research. I believe very strongly in a Federal--
reasonable Federal standard that would be--set a gold standard, 
as it were, for how research should be done in the Federal--in 
public--in publicly available labs, in privately funded labs, 
in pharmaceutical-company labs. I want private companies and 
all researchers, in fact, to have the same sort of ethical 
guidelines and standards so that we can publicly debate, 
publicly know what they're doing, and have it be a shared 
decisionmaking process, like it is with so much of other 
research.
    Senator Wyden. Well, I want to ask about one other area, 
but that's very much a view that I share, is, I think you ought 
to have a debate, you ought to make sure that everybody's 
heard. There are certainly a lot of stakeholders in this. For 
all practical purposes, hundreds of millions of Americans are 
stakeholders in this. But I think there's a reason that the 
states are going off and doing their own thing. And they are 
not, Dr. Doerflinger, you know, pursuing human cloning and--you 
know, in California, they are responding to the abysmal 
performance of the Federal Government, in terms of restricting 
the lines that are available.
    And I want to ask one last question on this first round, if 
I could, for Dr. Zoloth.
    Dr. Zoloth, I think I mentioned the reports indicating that 
something like 21 of the initial 78 stem cell lines are now 
available to researchers, scientists coming forward and saying 
a hundred new lines have been developed since the original 
cutoff by the President. I mean, it seems to me that these two 
facts, alone--these two facts alone--show the real consequences 
for researchers, in terms of this ``turn back the clock'' 
approach that is being chosen by this Administration in the 
field. Would you like to address those two facts, alone--the 
question of the reduction of the number of initial stem cell 
lines that's actually been available, and then the new lines 
that have been available? Because that seems to me to be--those 
areas are really what's taking the toll now on the prospects 
for research.
    Dr. Zoloth. I actually thought that President Bush's 
compromise was a sensible one when he made it in August 2001 
because it said, ``We'll allow this to go forward, and we will 
fund it federally, and we'll have some oversight at the NIH.'' 
The problem was that that--the lines didn't pan out. And so 
it's reasonable now to take another look at those limits and 
say, ``Since we had already made the compromise of using 
leftover embryos, can we expand them so that the scientific 
basis of that original thoughtful compromise could now be 
expanded to be more scientifically valid, and open it to a far 
wider number of lines, including the new lines that have been 
developed, and are being developed, with better technologies?''
    The scientists--and I'm not a scientist--the scientists 
tell me that one of the things that happens, and happens 
because science is global all over the world, is they're 
constantly developing new ways of growing these. It's a tricky 
business to grow these stem cell lines, and we want our 
American researchers to have access to the best and the 
freshest stem cell lines possible.
    Good stuff can be done with the ones that were funded and 
created a number of years ago, and I want to applaud the NIH 
for continuing to do that work. But that's just at the very, 
very early beginning, and we could expand that quite easily, 
even within the framework already established----
    Senator Wyden. My----
    Dr. Zoloth.--by this Administration.
    Senator Wyden.--my time is up. And that is a thoughtful 
response, because I think you're absolutely right, when you're 
in a controversial field, and people say, ``All right, I'd like 
to start here,'' then you start there, and you see what 
happens. But what has, in fact, happened--and you have pointed 
this out--is, we have gotten something like a third of the 
number of stem cell lines----
    Dr. Zoloth. Yes.
    Senator Wyden.--that people originally conceived of, plus 
another hundred are now, according to scientists, supposed to 
be out there. And I appreciate your answers.
    And thank you, Mr. Chairman.
    Senator Wyden. Thank you.
    Mr. Dorgan? We'll go in order of appearance.

              STATEMENT OF HON. BYRON L. DORGAN, 
                 U.S. SENATOR FROM NORTH DAKOTA

    Senator Dorgan. Mr. Chairman, thank you very much.
    I did not hear the testimony of the witnesses because I was 
elsewhere, but I thank you for appearing.
    Let me follow up on Senator Wyden's question to Mr. 
Doerflinger. In an in vitro fertilization clinic, there are 
fertilized eggs that are not used, and frozen, and then later 
discarded. Let me ask about the status of a fertilized egg that 
is now frozen at one of those clinics. Is that, ``a member of 
the human race,'' as you use the term?
    Mr. Doerflinger. Yes, Senator, it's no longer a fertilized 
egg; it's now an embryo that consists of, depending on when 
they froze it, four or eight or sixteen or maybe a hundred 
cells.
    Senator Dorgan. So you have great angst about those being 
discarded, I assume.
    Mr. Doerflinger. Well, I think it's immoral to discard a 
human embryo. But the embryos that parents choose to discard 
are not the ones available for research, obviously.
    Senator Dorgan. Right. And there are now about one million 
children born as a result of the work at in vitro fertilization 
clinics. And that, it seems to me, is a process that is giving 
life, and it would seem to me to be pro life in its impact on 
our country and on the parents and on the children who are 
born. But your position, as I understand it, is that you do not 
support the in vitro fertilization. Is that correct?
    Mr. Doerflinger. That's correct, Senator. We understand the 
desires of infertile couples and the good goal that's intended. 
But a lot of the hard questions in morality have to do with 
whether the means to the end are worthy of the end. And here, 
we have a process that basically takes reproduction away from 
the parents. The act of conception is done by a laboratory 
technician in a laboratory dish and obviously exposes these 
embryos to a lot of dangers of dying in the laboratory, of 
being discarded, of being misused for research.
    Senator Dorgan. So your position is, there's an equivalency 
between a fertilized egg that is now frozen at an in vitro 
fertilization clinic and a 40-year-old person suffering from 
Parkinson who might--Parkinson's disease or some other 
disease--that might benefit from the research that comes from 
stem cell research. There's an equivalency. Both are, ``members 
of the human race,'' and deserve equal status and equal 
protection. Is that fair?
    Mr. Doerflinger. Equal protection is probably the right 
word. Neither of these should be killed to help anybody else.
    Senator Dorgan. All right. And so your position is that 
those who--those fertilized eggs at an in vitro fertilization 
clinic are being discarded are being killed, that is the 
killing of a human?
    Mr. Doerflinger. They're certainly being neglected.
    Senator Dorgan. Are they being killed?
    Mr. Doerflinger. Well, I think there's direct killing when 
you take the inner cells out and destroy them for research. 
It's more negligent when you just leave them out to thaw and 
die.
    Senator Dorgan. I react--you know, I react strongly to 
those that use the term ``kill'' and ``murder.'' I've heard, 
until I'm about sick, of the term ``clone and kill,'' 
``murdering embryos,'' and so on. And----
    Mr. Doerflinger. Well, I don't use the word ``murder,'' 
Senator.
    Senator Dorgan. I understand you didn't. But I--it's used 
all over the country in this debate, and I----
    Mr. Doerflinger. How about the word ``destroy''?
    Senator Dorgan. Let me ask, also, about the issue of the 
cloning of a cell. My colleague Senator Brownback asked the 
question about, Do you favor human cloning? I'm not sure I 
understand what that question means. If it's the cloning of a 
human being, I assume everyone here agrees that there ought to 
be criminal penalties against it. If the question is to elicit 
an answer with respect to the cloning of a cell to--somatic 
cell nuclear transfer--for the purpose of embryonic stem cell 
research, that's a different set of issues. I don't know what 
the intent of the question was.
    Senator Brownback. Mine was to Dr. Zoloth to ask her if she 
supported human cloning.
    Senator Dorgan. Is that the somatic cell--would that be 
therapeutic?
    Senator Brownback. That's the creation of a human being by 
means of the cloning process that was used to create Dolly.
    Senator Dorgan. So----
    Senator Brownback. At the very earliest of stages.
    Senator Dorgan. Then I think--but I think all of us would--
we'd reach agreement on that point. We don't intend to try to 
create a Dolly or a human version of Dolly. So I think we all 
agree on that point. I think--let me just ask a couple of 
question of Dr. Zoloth on the question of somatic cell nuclear 
transfer.
    We, I think, 30 years ago, in addition to having a debate 
about the opening of in vitro fertilization clinics and having 
people talk about how awful that would be and so on, we had a 
debate about recombinant DNA cloning back then, and the same 
specter of discussions back then about the fear that science 
was going too far, too fast. They weren't sure what would come 
from the Harvard laboratories, what would, ``crawl out of the 
laboratory,'' was the reason one city passed an ordnance 
against it, and so on. And I know that that's a different type 
of cloning; but, nonetheless, it is a debate that we constantly 
have about scientific inquiry.
    And let me ask you the question, whether it is using your 
skin cell from your earlobe through the cloning of that cell 
and the development of embryonic stem cells or an embryonic 
stem cell that's derived from a fertilized egg that's to be 
discarded at a clinic, is there--and I don't know that you're 
the right person to ask this--but is there a dramatic 
difference in the experience with respect to embryonic stem 
cells and also the promise of adult stem cells with respect to 
this kind of research?
    Dr. Zoloth. These are complicated questions, and I want to 
try to answer them separately.
    The first is, we did have a debate about recombinant DNA 
technology. It wasn't really cloning, but it did raise the 
issue of the specter of genetic manipulation. And it was 
resolved, in large part, because scientists, themselves, agreed 
to set their own limits and they established the kind of 
Federal guidelines that Mr. Wyden talked about at the 
Recombinant DNA Technology Committee that oversees, and still 
does oversee, recombinant DNA technology experiments.
    Senator Dorgan. Can I just interrupt----
    Dr. Zoloth. But the decline----
    Senator Dorgan.--for one moment----
    Dr. Zoloth. Yes.
    Senator Dorgan.--to ask this question? My understanding 
about the monoclonal antibodies issue is that the development 
of new cancer therapies is, the cloning of cells that produce 
special antibodies. So there is a cloning process----
    Dr. Zoloth. Yes.
    Senator Dorgan.--in there, isn't there?
    Dr. Zoloth. It means--cloning means doubling, means 
replicating. And so----
    Senator Dorgan. Replicating, copying.
    Dr. Zoloth.--in essence, it makes copies.
    Senator Dorgan. Right.
    Dr. Zoloth. The International Society of Stem Cell Research 
just has decided that the word ``cloning,'' itself, can be 
confusing because it has so many scientific meanings--to use 
the words ``somatic cell nuclear transfer'' or ``nuclear 
transfer'' to define the thing that people are really worried 
about, which is taking an adult nucleus and putting into a 
human--in human egg and then starting the process of a new 
blastocyst creation at that moment.
    So then you asked a second question, which is, Is there a 
difference in that sort of blastocyst that's created that way 
and in the blastocysts created through the normal gametes--two 
gametes mixing? And the answer is, scientifically, we don't 
know yet. We can't know such a thing yet. We know a few 
experiments in animals--obviously, not in humans, for very good 
reasons--and we can't yet know.
    And that's the interesting thing about this early 
technology. It's very early. And that's why I think it's more 
like free speech, because the basic thing that we are 
thinking--or I'm--as I look over the shoulder of the scientists 
in the labs, as an ethicist--is, they're learning how cells 
signal and change and grow and die. And so growth and death and 
change is the basis for all human disease. Basic research is 
very basic. We're well before applications, but we won't get to 
the applications if we don't know how cells change and become 
from an undifferentiated cell, a pluripotent cell, into a 
committed cell. And that shift is a very unexplored one, and 
it's that exploration that this research is aimed toward.
    Senator Dorgan. Just one comment, to say that I think that 
there are significant ethical, religious, moral issues around 
all of these discussions. I understand that. I think we should 
move carefully with regard to all of that. But, in the end, I 
also believe differently, for example, than Dr. Doerflinger, 
that things like the in vitro fertilization clinics, the 
advances in research, the capability to save lives is very 
important, even as we think through all of these more difficult 
issues.
    I thank you for the time.
    Senator Brownback. Thank you.
    Mr. Ensign?

                   STATEMENT OF JOHN ENSIGN, 
                    U.S. SENATOR FROM NEVADA

    Senator Ensign. Thank you, Mr. Chairman. Thanks for having 
these incredibly important hearings.
    And I agree with you, Senator Dorgan, that the questions 
raised with these issues are difficult from a moral standpoint, 
regardless of your viewpoint, difficult from a scientific 
standpoint. And so I want to explore a little bit about how we 
make these moral decisions.
    Dr. Zoloth, you've talked about that you would be against 
human cloning for reproductive purposes, but then you said 
``but not for basic research.'' Am I correct in that?
    Dr. Zoloth. That's correct.
    Senator Ensign. How do you make the moral stand that one is 
OK and one isn't? In other words, where do you get your morals 
to judge that one is OK and one isn't?
    Dr. Zoloth. That's a very interesting question. To what 
extent does my religious faith influence my moral position as a 
bioethicist, as an academic bioethicist?
    Senator Ensign. Well, I don't even know if you have a 
religious faith. I just want to know how you make these moral 
decisions.
    Dr. Zoloth. To make the distinctions, all right. In two 
ways. The first really is that I am--I'm guided in these issues 
which--like when life begins--which I believe are deeply 
theological, religious issues, by my position as an orthodox 
Jew and by the process of examination of the science by 
religious leadership and by scholars, in light of the text and 
in light of the traditional of Judaism. And so that does inform 
my opinion and my passion. Just as Mr. Doerflinger's position 
is deeply informed by his Catholic moral theology, mine is 
deeply informed by Judaism and the orthodox tradition from 
which I speak. So that's one answer.
    The other answer is the years of study and research that my 
field, American bioethics and international bioethics, has done 
in taking a look at these complicated ethical and moral 
debates. I like good arguments from whatever religious 
tradition they emerge, from whatever philosophical tradition 
emerge. And that's how I became convinced, by listening not 
only to my own sources, but to the wise counsel and the 
gravitas of the Catholics and of the Protestants, the 
Buddhists, the Hindus, who all have looked at this issue with 
great and exquisite care. And I've come to a position that I 
think that human reproductive cloning is wrong in the same way 
that slavery is wrong, in the same way that certain forms of 
servitude are wrong----
    Senator Ensign. Well, why is it wrong?
    Dr. Zoloth. I think because of one thing that's important 
to me. I think it gives us a very distorted idea about the--our 
ideas of death. That's actually what I come down to about human 
cloning. I think--because our usual argument is, it's 
completely unsafe. And I can't conceive of an experiment that 
we could prove it's safe inside the woman's body. I mean, I 
just can't think of a way to--even if you had hundreds of 
animal studies that proved it's safe, how would the first human 
experiments be done? As a bioethicist, it's hard to imagine the 
phase-one clinical trial that one could design.
    But the moral issue for me is that I think it confuses us 
about the limits of human mortality and the limits of death 
itself if it's ever used to try to replace an actual human 
person.
    Senator Ensign. OK.
    Dr. Zoloth. That's the sort of confusion that I would pose.
    Senator Ensign. And the reason I'm asking this, and I don't 
want to be combative--the reason I'm going down this line of 
questioning is because some who are in favor of embryonic stem 
cell research are looking at it from strictly a pragmatic point 
of view. You're going to help other people with the research 
over here, you know, and that's a greater good. That's what 
their morality is telling them. And then there are others that 
are looking at it from their moral absolute point of view, you 
know, saying, ``This is a human being, and we shouldn't mess 
with it.'' And because we don't know these questions--you know, 
first rule of medicine is, ``Do no harm,'' and if you're, you 
know, somebody who is looking at our Creator, you know, our 
first rule in that regard would be ``Don't violate whatever His 
law is set down to us.''
    So it is important to grapple with these as we're going 
forward. And I think it's important for the entire community, 
regardless of which side somebody comes down on, on this issue, 
for people to recognize that there is a lot of internal 
struggle on our personal moral standpoints from this. And 
people do disagree, depending on their background.
    But the bottom line is, this is a moral decision.
    Dr. Zoloth. Yes.
    Senator Ensign. It is a moral decision, and we have to 
figure out from where we are defining our morality. You know, I 
do this exercise with kids all the time in high school. You 
mentioned slavery is wrong. Well, why is slavery wrong? Kids 
will say, ``Well, because, you know, it's wrong to enslave, you 
know, one set of people over another.'' And I say, ``Well, 
why?'' And they say, ``Well, you know, we've, you know, decided 
as a, you know, society that that's wrong.'' And I'll ask them, 
I'll say, ``Well, what if we decided as a society, like many 
societies did, that that was OK. Would it make it OK?''
    The bottom line is, I bring them to a point--you have to 
come with certain moral absolutes. There has to be rights and 
wrongs.
    Dr. Zoloth. Yes.
    Senator Ensign. There are no rights and wrongs, and moral 
relativism is the way of the world, then you can justify 
anything. You could justify human cloning. I mean, there's no 
question, with moral relativism, what's wrong with human 
cloning? If there is no higher power to answer to this, none of 
this is wrong.
    Dr. Zoloth. I completely agree with you. And what's 
interesting and wonderful about living in America is that we're 
allowed to hear the voice of that higher power in a very 
diverse number of ways--one hears the call of God's law in a 
number of ways, and then you, as the U.S. Senate, have to 
decide what to do with a country that hears God's law in such 
complicated and divergent ways.
    Senator Ensign. Right.
    Dr. Zoloth. And that's where science policy comes into 
play, to respect that voice, to honor it, and to care for each 
minority view that you hear, and then----
    Senator Ensign. The difference is that when we--as 
policymakers, we have to make that moral choice. I mean, 
that's--our laws are based on morals.
    Dr. Zoloth. Yes.
    Senator Ensign. So we have to--at a point, we have to say 
where we come down, and we have to make the call. There can be 
all the arguments in the world and all the discussion in the 
world, but, you know, the kind of--we have to then decide, 
based on our individual morals or the morals we represent in 
America, where those laws are going to come to effect.
    I don't know, Mr.--I didn't give you a chance to respond to 
any of this conversation. If you'd like jump in--as my time is 
very short----
    Mr. Doerflinger. OK, thank you very much, Senator.
    Just to clarify something about cloning. The cloning--and 
we're not talking about monoclonal antibodies. That's just 
replicating cells in a culture and it doesn't have anything to 
do with human embryos--but there's one technique of cloning 
called somatic cell nuclear transfer. It makes a human embryo. 
There's only one such procedure available right now that people 
are debating. And some people have said there's a difference 
between reproductive cloning and therapeutic cloning. But 
that's really not a difference in the procedure; it's simply a 
difference in what you do with the embryo after you've cloned 
it.
    Senator Ensign. Correct.
    Mr. Doerflinger. Some people want to put it in a womb and 
get a baby. A very risky procedure, by the way. And some want 
to put it in a dish and destroy it for its stem cells. The 
distinction between the two is increasingly breaking down, for 
two reasons.
    One is that the fertility clinics realize--and the 
researchers realize--that any research that advances in 
refining somatic cell nuclear transfer for research purposes 
will equally serve the wild and crazy guys who want to do this 
for reproductive purposes, since the technique is exactly the 
same.
    The second way it's breaking down is that in the laboratory 
of the states, the new laws that have been proposed by the 
biotechnology industry to allow cloning for research have 
increasingly started changing the definition of where the 
distinction lies. Increasingly--and this is already passed in 
New Jersey--you have bills introduced, and some passed, that 
say, ``It's not reproductive cloning unless you get a live 
birth.'' You could put that embryo in a woman's womb, you could 
gestate it into late fetal stages, and abort it for its 
tissue--which, at this point, has been done in animals--and 
call that ``therapeutic cloning.''
    Cloning is allowed, and will be given state funds, under 
this California ballot initiative, Proposition 71. Because of 
their market research, they don't call it cloning; they call it 
somatic cell nuclear transfer. But it's exactly the same thing.
    Senator Dorgan. Would the Senator yield on that point?
    Senator Ensign. Could we have Dr. Zoloth just comment on--I 
mean, from what I understand from, at least, my scientific 
background, they are the same process, up to a point, in what 
he is talking about. Do you disagree with what he said, as 
for--up to a process, they're basically the same thing?
    Dr. Zoloth. You create a blastocyst. That is, in fact, 
true. It's not a marketing campaign. It's trying to be clear 
about the scientific language and to really describe the 
process, which is taking a human nucleus, an adult nucleus, and 
putting it in an egg----
    Senator Ensign. I guess--here's the simplest way to 
describe it. Is there any difference between--up to that 
point----
    Dr. Zoloth. Yes.
    Senator Ensign.--where you go to then use it, is there any 
difference between how Dolly was cloned--how Dolly was created, 
up to that point, and somatic cell nuclear transfer?
    Dr. Zoloth. In humans, that question has not been fully 
answered, biologically. That's what I'm told, that we don't 
know yet. Because human biology is different from sheep 
biology, and we don't know clearly----
    Senator Ensign. I'm just talking about the----
    Dr. Zoloth. We don't know.
    Senator Ensign.--I'm talking about the study, though, or 
the technique--well, now, this is a fundamental question. The 
technique to get to that point is the same. That is the point 
of it.
    Dr. Zoloth. The technique is the same. There's no question 
about that.
    Senator Ensign. OK, so--and that--yes.
    Senator Brownback. We've got a second panel----
    Senator Dorgan. Mr. Chairman?
    Senator Brownback. Yes?
    Senator Dorgan. Let me just, if I might, just clear up one 
point. I had asked the Senator if he would yield. I understand 
he was out of time, but I don't want the panel to leave, 
leaving in the air this notion of putting a cloned embryo in 
the uterus----
    Dr. Zoloth. Right.
    Senator Dorgan.--for the purpose of harvesting body parts. 
That is the most preposterous nonsense I've ever heard. Are you 
aware of anybody in the country that's proposing that sort of 
thing?
    Mr. Doerflinger. Footnote 40 in my testimony, Senator. 
Three different animal trials, in each of which the animal, the 
cloned animal embryo, could not produce usable tissues for the 
transplants until they had gestated and brought it to the fetal 
stage. In the most recent one, conducted by Robert Lanza et 
al., of Advanced Cell Technology, they had to develop the 
cloned mouse embryo to the equivalent of the fifth to sixth 
month in humans, and then abort it to obtain usable cells that 
were used to try to repair heart damage in a mouse. The 
researchers declared in their press release that ``This is an 
important new paradigm,'' for human therapeutic cloning.
    Senator Dorgan. Well, that's not responsive to my question. 
We've also cloned a sheep and dairy cows, but I was asking 
whether you know of anybody that wants to implant a cloned 
embryo in a uterus for the purpose of harvesting body parts. No 
one that I know of in this country has proposed that. It's 
preposterous.
    Mr. Doerflinger. They are proposing it, Senator, I'm sorry.
    Senator Dorgan. Who's proposing it?
    Mr. Doerflinger. To deny it is preposterous.
    Senator Dorgan. Dr. Zoloth?
    Mr. Doerflinger. That's exactly how the New Jersey law is 
crafted.
    Senator Dorgan. Well, that is--that is nonsense. The fact 
is, no one in this country----
    Mr. Doerflinger. I agree it's nonsense, but I insist to you 
that it's happening, and I'll give you more documentation.
    Senator Dorgan. Well, Mr. Chairman, it is a specter of this 
debate that is the worst, in my judgment, of this debate. It is 
not thoughtful.
    Senator Brownback. Well, this should--if--this should be 
able to track this, whether or not this is the case or not, 
and----
    Mr. Doerflinger. I'll be very happy to----
    Senator Brownback.--let us get----
    Mr. Doerflinger.--give you the supplemental documentation.
    Senator Brownback.--laws, and let's get a copy of the New 
Jersey law and put it in.
    Dr. Zoloth. It's----
    Senator Brownback. And, Dr. Zoloth, if you would care to 
respond----
    Dr. Zoloth. I just----
    Senator Brownback. And I want to go to the next panel then.
    Dr. Zoloth. I think it's real important. Mr. Dorgan has 
raised a very important point. We're talking about very early 
basic science research. It's important not to do science 
fiction or to instill fear in the American public. We've had 
quite enough of that, I think.
    No responsible researcher, no IRB, no bioethicist in this 
country would ever pass, support, or approve such a protocol. 
It is unthinkable.
    Senator Brownback. Have you reviewed the New Jersey law?
    Dr. Zoloth. New Jersey law, I think, does not imply that at 
all.
    Senator Wyden. Mr. Chairman, before----
    Senator Brownback. But does the New Jersey law allow that?
    Dr. Zoloth. No, I don't think the New Jersey law would 
allow that.
    Senator Wyden. Mr. Chairman?
    Senator Brownback. OK. Well----
    Dr. Zoloth. It's about animal----
    Senator Wyden. That's the----
    Dr. Zoloth.--it's about animal research. It's really quite 
a different category.
    Senator Wyden. Right. Before a riot breaks out----
    [Laughter.]
    Senator Wyden.--that is the key point. It has not been done 
with respect to humans.
    Dr. Zoloth. Right. It's not about humans.
    Senator Wyden. We are talking about animals. And I agree 
with the Chairman, we can have these debates in a thoughtful 
way. I mean, this is--and I've been trying to make my way 
through footnote number 40----
    [Laughter.]
    Senator Wyden.--but I think my reading of footnote number 
40 that you cited, Doctor, is that it does not apply to humans. 
And that's why I thought the point made by Senator Dorgan was 
important.
    Senator Brownback. Let's--and we'll get a copy of the New 
Jersey law, and let's put it in the record, so we'll have it as 
part of this.
    [The information referred to follows:]
    
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
                                ------                                

    Senator Brownback. We'll get the second panel up before we 
get further here. I thank both panelists very much. I think 
this is an excellent discussion, and one we should do more of.
    First will be Dr. George Daley, Associate Professor of 
Pediatrics and Biological Chemistry and Molecular Pharmacology, 
Children's Hospital, Harvard School of Medicine out of Boston; 
next, Dr. David Prentice, Senior Fellow, Family Research 
Council in Washington, D.C.; and then Dr. Marc Hedrick, 
President, MacroPore Biosurgery out of San Diego, California. 
Delighted that all of you could join us.
    Dr. Daley, thank you for being here. I'd say to all the 
panelists your written testimony will be put into the record. 
If you'd like to summarize, that's quite all right. And I think 
you should gather from us we like to have a good period of 
question and answer, if we could do that.
    Dr. Daley?

  STATEMENT OF GEORGE Q. DALEY, M.D., Ph.D., REPRESENTING THE 
               AMERICAN SOCIETY FOR CELL BIOLOGY

    Dr. Daley. Yes, thank you.
    Senator Brownback, Members of the Committee, thank you for 
inviting me to testify. I am here today representing the 
American Society for Cell Biology, which represents over 8,000 
basic biomedical researchers in the United States.
    I am a physician scientist. I am clinically active in the 
care of children and adults with malignant and genetic diseases 
of the blood. I run an NIH-supported laboratory and hold grants 
pertinent to both adult and embryonic stem cells. We study 
chronic myeloid leukemia, a cancer that arises from the adult 
blood stem cell, and we investigate how to coax embryonic stem 
cells to differentiate into blood.
    My laboratory can transplant mice with blood stem cells 
derived entirely in vitro from embryonic stem cells. Our goal 
is to replicate this success using human embryonic stem cells, 
with the hope of someday treating patients with leukemia, 
immune deficiency, aplastic anemia, and genetic diseases like 
sickle cell.
    At the core of the controversy we're discussing today are 
principles that are informed more by religious and moral 
beliefs than by scientific issues. However, the scientific 
issues, indeed, play an important role in the debate. As with 
most controversies, much misinformation and spin exists. Today, 
I am here to offer scientific testimony to help clarify the 
facts and dispel the myths surrounding competing claims in 
adult and embryonic stem cell research.
    I will address two central scientific questions. First is 
research on human adult stem cells so promising that we need 
not pursue research with embryonic stem cells? And second is 
the current Presidential policy that restricts federally funded 
researchers to only a limited set of cell lines adequate to 
explore the potential of human ES cell research?
    The simple, but emphatic, answer to the first question is, 
no. Although research on adult stem cells is enormously 
valuable, adult stem cells are not the biological equivalents 
of embryonic stem cells, and adult stem cells will not satisfy 
all medical and scientific needs.
    Unequivocally, adult stem cells have been isolated from 
bone marrow, skin and mesenchyme, which would include fat, but 
adult stem cells do not appear to exist for all tissues of the 
body, especially all tissues that are ravaged by disease. 
Claims of stem cells for the heart, pancreas, and kidney remain 
controversial.
    You will also hear claims that adult stem cells are highly 
plastic, perhaps as versatile as embryonic stem cells, and that 
success with adult stem cells obviates the need to study ES 
cells.
    As an expert in both the biology of adult and embryonic 
stem cells, I disagree with these claims. It is the nature of 
adult stem cells to regenerate only a limited subset of the 
body's tissues. As best we can tell under normal physiology, 
adult stem cells do not have a measurable capacity to replenish 
cells beyond their tissue of origin. Therefore, asking blood 
stem cells to regenerate heart or liver or brain is to ask 
adult stem cells to betray their intrinsic nature. Like 
cellular alchemy, attempts to engineer adult stem cell 
plasticity may never succeed in a clinically practical manner.
    While the differentiation spectrum of adult stem cells is 
restricted, it is an incontrovertible scientific fact that 
embryonic stem cells can form all cells in the body. Such is 
the natural destiny of the stem cells of the early embryo, and 
the reason they inspire such fascination among biologists.
    Claiming that the promise of adult stem cells trumps the 
need to study embryonic stem cells is an opinion at the fringe, 
not the forefront, of scientific thinking. The American Society 
of Cell Biology and every other major scientific society 
supports the study of both adult and embryonic stem cells.
    To the second question, ``Is the current Presidential 
policy adequate to explore the potential of ES cell research,'' 
I also answer an emphatic no. Today, federally funded 
scientists operate under a restrictive policy that limits us to 
a modest number of cells generated over 3 years ago. We cannot 
use new lines, and, consequently, cannot take advantage of the 
latest tools to explore some of the most medically promising 
avenues. It runs contrary to the American spirit of innovation 
for our government to deny its scientists every advantage to 
push the frontiers. The President's policy is slowing research, 
and it's compromising the next generation of medical 
breakthroughs.
    I recently published an article in the New England Journal 
of Medicine entitled ``Missed Opportunities in Human Embryonic 
Stem Cell Research.'' In it, I point out that in the 3 years 
since the President announced his policy, over a hundred 
additional lines have been generated, some which model diseases 
like cystic fibrosis, muscular dystrophy, and genetic forms of 
mental retardation. What does the President say to families 
whose children are affected by these devastating diseases? How 
does the President justify his lack of support for this 
research? Where is the compassion in such a conservative 
policy?
    I am the father of two young boys, Nick and Jack, ages 3 
and 6. Currently, I'm taking great delight in teaching them 
baseball. I count my blessings for their health; more so every 
time I walk through the lobby of the Children's Hospital and I 
see the many kids in wheelchairs who will never know the 
excitement of running the bases or smacking a home run.
    As a physician, I wholeheartedly support ES cell research, 
and I see it delivering the medical breakthroughs of tomorrow.
    As a scientist engaged in stem cell research, I have 
listened intently to the voices arguing against our work. I do 
not accept that the interests of microscopic embryos should 
trump the needs of patients.
    I firmly believe that our research mission, which is to 
advance human knowledge in the hopes of improving health and 
relieving human suffering, is compassionate, life-affirming, 
and dedicated to the highest ideals of medicine. This important 
work must continue, and it is in the best interest of our 
society for our government to support it.
    Thank you.
    [The prepared statement of Dr. Daley follows:]

 Prepared Statement of George Q. Daley, M.D., Ph.D., Representing the 
                   American Society for Cell Biology
    Senator Brownback, members of the Committee, thank you for inviting 
me here today to testify before you. My name is George Daley. I am here 
representing The American Society for Cell Biology where I serve as a 
member of the Public Policy Committee. The ASCB represents over 11,000 
basic biomedical researchers in the United States and in 45 other 
countries.
    [For the record, I am Associate Professor of Pediatrics and 
Biological Chemistry at the Boston Children's Hospital and Harvard 
Medical School, Associate Director of the Children's Hospital Stem Cell 
Program, a member of the Executive Committee of the Harvard Stem Cell 
Institute, a Board member of the International Society for Stem Cell 
Research, and chair of the Scientific Review Committee of the Stem Cell 
Research Foundation. I received one of the first grants issued by the 
NIH for the study of human embryonic stem cells.]
    I am a physician-scientist, board certified in Internal Medicine 
and Hematology and clinically active in the care of children and adults 
with malignant and genetic diseases of the blood and bone marrow. I run 
an NIH-supported laboratory that studies both adult and embryonic stem 
cells. Part of my lab focuses on the human disease Chronic Myeloid 
Leukemia, a cancer that arises from the adult blood stem cell. Part of 
my lab is investigating how to coax embryonic stem cells to 
differentiate into blood stem cells. My laboratory has succeeded in 
transplanting mice with blood stem cells derived entirely in vitro from 
embryonic stem cells. Our goal is to replicate this success using human 
embryonic stem cells, with the hope of someday treating patients with 
leukemia, immune deficiency, aplastic anemia, and genetic diseases like 
sickle cell anemia.
    As the title of the hearing states, controversy surrounds the field 
of human embryonic stem cell research. At the core of the controversy 
is the fact that harvesting embryonic stem cells requires the 
destruction of a human embryo. If you ascribe full personhood to the 
earliest stages of human development, then you are vigorously opposed 
to embryonic stem cell research and opposed to fertility treatments 
that generate embryos that are the source of embryonic stem cells. In 
contrast, if you believe that the earliest human embryos, as 
microscopic balls of primitive cells, are not the moral equivalents of 
babies, then you are likely to be equally vigorous in supporting 
embryonic stem cell research because of its immense promise for 
understanding and treating disease. These dueling perspectives are 
informed more by religious and moral beliefs than by scientific 
principles. However, scientific issues indeed play an important role in 
the current debate. As with most controversies, much misinformation 
exists. Today, I am here to offer scientific testimony to clarify the 
facts and dispel the myths surrounding competing claims in adult and 
embryonic stem cell research.
    I will address two central scientific questions: First, is research 
on human adult stem cells so promising that we need not pursue research 
with embryonic stem cells? Second, is the current Presidential policy 
that restricts researchers to only a limited set of cell lines created 
before August 9, 2001 adequate to explore the potential of human 
embryonic stem cell research?
    The simple but emphatic answer to the first question is ``no.'' 
Although research on adult stem cells is enormously promising and has 
already yielded clinical success in the form of bone marrow 
transplantation, adult stem cells are not the biological equivalents of 
embryonic stem cells, and adult stem cells will not satisfy all 
scientific and medical needs. Moreover, a great many questions about 
adult stem cells remain unanswered. Adult stem cells have been 
unequivocally isolated from bone marrow, skin, and mesenchyme, but 
adult stem cells do not appear to exist for all tissues of the body. 
Claims of stem cells for the heart, pancreas, and kidney remain 
controversial. You will also hear claims that adult stem cells are 
plastic, perhaps as versatile as embryonic stem cells, and that success 
with adult stem cells obviates the need to study embryonic stem cells. 
As an expert in both adult and embryonic stem cell biology, I take 
issue with these claims. It is the nature of adult stem cells to 
regenerate only a limited subset of the body's tissues. As best we can 
tell, under normal physiologic circumstances, adult stem cells do not 
have a measurable capacity to differentiate beyond their tissue of 
origin. Therefore, asking blood stem cells to regenerate heart or liver 
or brain is to ask adult stem cells to betray their intrinsic nature. 
Like cellular alchemy, attempts to engineer adult stem cell plasticity 
may never succeed in a clinically practical manner. I am not arguing we 
should not invest in some highly speculative realms of cellular 
engineering with adult stem cells. Indeed, we should. I am arguing 
however, that the promise of adult stem cells in no way obviates the 
need to investigate embryonic stem cells. Claiming that the study of 
adult stem cells should trump the study of embryonic stem cells is an 
opinion at the fringe and not the forefront of scientific thinking.
    While the differentiation spectrum of adult stem cells is 
restricted, it is an incontrovertible fact that embryonic stem cells 
have the ability to form all cells in the body. Such is the natural 
endowment of the stem cells of the early embryo, and the very reason 
they inspire such fascination among stem cell biologists. Scientists 
are seeking to discover the natural mechanisms that drive formation of 
specific cells and tissues, so that these principles can be faithfully 
reproduced with embryonic stem cells in the Petri dish. I would argue 
that coaxing embryonic stem cells to do what comes naturally to them is 
more likely to prove successful in the near term than reengineering 
adult stem cells towards unnatural ends. The American Society of Cell 
Biology and every other major scientific society supports the study of 
both adult and embryonic stem cells.
    To the second question, ``Is the current Presidential policy 
adequate to explore the potential of human embryonic stem cell 
research?'' I also answer an emphatic ``no.'' Today, federally-funded 
scientists operate under a restrictive policy that limits the human 
embryonic stem cells that can be studied to a modest number of lines 
generated over three years ago. With the pre-2001 vintage cell lines we 
can address generic questions, but are prohibited from exploiting the 
latest tools being developed around the Globe. It runs contrary to the 
American spirit of innovation for our government to deny its scientists 
every advantage to push the frontiers. Ultimately this will slow the 
pace of medical research, and compromise the next generation of medical 
breakthroughs. I recently published an article in the New England 
Journal of Medicine entitled ``Missed opportunities in human embryonic 
stem cell research'' \1\, in which I articulated the scientific avenues 
that are not being adequately investigated due to the current 
Presidential policy. In the three years since the President announced 
his policy, over a hundred additional lines have been generated, many 
with advantageous properties that make them highly valuable to medical 
scientists. Some of these new lines model diseases like cystic 
fibrosis, muscular dystrophy, and genetic forms of mental retardation. 
What does the President say to families whose children are affected by 
these devastating diseases? How does the President justify his lack of 
support for this research? Where is the compassion in such a policy?
---------------------------------------------------------------------------
    \1\ Daley GQ. Missed opportunities in embryonic stem cell research. 
N Engl J Med 351:627-8, 2004.
---------------------------------------------------------------------------
    Thankfully, I am the father of two healthy boys, ages 3 and 6. I am 
taking great delight in teaching them baseball and watching them root 
for the Red Sox. (They have much to learn about heartache in the 
world). As a father, I count my blessings for these God-given gifts, 
more so every time I walk through the lobby of the Children's Hospital, 
and see the many kids who will never run the bases or smack a home run. 
As a physician, I see the mission of ES cell research as providing the 
greatest hope to relieve the suffering I see in many of my patients. As 
a scientist, I am not impervious to the expressions of ethical concern 
for the sanctity of the human embryo. But in our religiously plural 
society, I fear we may never reach an ethical consensus given the 
competing entities in this debate: microscopic human embryos that 
represent incipient human life on the one hand, desperate patients 
suffering from debilitating diseases on the other. From my perspective 
as a father, physician, and scientist, I am moved by concern for my two 
boys, my patients, and for the life-affirming mission of hope and 
promise in embryonic stem cell research.

    Senator Brownback. Thank you, Dr. Daley, for your 
presentation.
    Dr. Prentice?

       STATEMENT OF DR. DAVID A. PRENTICE, Ph.D., SENIOR

       FELLOW FOR LIFE SCIENCES, FAMILY RESEARCH COUNCIL;

       AFFILIATED SCHOLAR, CENTER FOR CLINICAL BIOETHICS,

              GEORGETOWN UNIVERSITY MEDICAL CENTER

    Dr. Prentice. Thank you, Mr. Chairman.
    Mark Twain noted that, ``There is something fascinating 
about science; one gets such wholesale returns of conjecture 
out of such a trifling investment of fact.'' This is certainly 
true regarding the hype and emotion surrounding the stem cell 
issue.
    I'd like to start with some biological definitions, more of 
which are in my written testimony, to provide a common 
scientific frame of reference. This is from Patten's 
``Foundations of Embryology, Sixth Edition.'' ``Almost all 
higher animals start their lives from a single cell, the 
fertilized ovum, or zygote.'' The time of fertilization 
represents the starting point in the life history or ontogeny 
of the individual. Thus, within the body or in the laboratory 
via in vitro fertilization, the first stage of development of a 
new individual begins with fertilization. Because it has become 
an area of interest, it is useful to point out that, 
biologically, the process of cloning, also termed somatic cell 
nuclear transfer, or SCNT, also produces a zygote as a starting 
point for development.
    The President's Council on Bioethics has noted, quote ``The 
first product of SCNT is, on good biological grounds, quite 
properly regarded as the equivalent of a zygote and its 
subsequent stages as embryonic stages in development,'' end 
quote.
    The National Academy of Sciences has also noted that 
embryonic stem cells can be isolated from blastocyst-stage 
embryos early in human development, whether produced by 
fertilization or by cloning, and has called those blastocysts 
by the same name, whether produced by either technique.
    The first question we might address, then, is, Why use stem 
cells? Well, the short answer is to treat degenerative diseases 
such as heart disease, stroke, chronic lung disease, 
Parkinson's, and diabetes. The stem cell has two chief 
characteristics. It multiplies, maintaining a pool of stem 
cells; and, second, given the correct signal, it can 
differentiate into other specific cell types for use by the 
body.
    Embryonic stem cells were first isolated in mice in 1981, 
and in humans in 1998. Adult stem cells were first identified 
in bone marrow in the 1960s, and in recent years have been 
found in a wide range of tissues throughout the body.
    Embryonic stem cells are derived by removing the inner cell 
mass of the early human embryo, or blastocyst; and, in this 
process, the embryo is destroyed. The cells purportedly have 
the advantage that they can proliferate indefinitely and can 
form any tissue.
    Scientific publications document the claim that they can 
proliferate for long periods of time, but the experimental 
basis for their potential to form any tissue relies on the 
cells being within the normal developmental context of the 
embryo.
    The published literature, however, shows that claims for 
embryonic stem cell advantages over adult stem cells are, so 
far, unsubstantiated. The National Institutes of Health 
actually has noted, ``Thus, at this stage, any therapies based 
on the use of human embryonic stem cells are still hypothetical 
and highly experimental.'' And also quotes, ``Whether embryonic 
stem cells will provide advantages over stem cells derived from 
cord blood or adult bone-marrow hematopoietic stem cells 
remains to be determined.'' There are no current clinical 
treatments based on embryonic stem cells; in fact, only few and 
modest published successes using animal models of disease. For 
embryonic stem cells, there is difficulty in obtaining pure 
cultures of specific cell types in the laboratory dish. There 
is a potential for tumor formation. The cells are actually 
difficult to establish and maintain in culture, and they face a 
significant risk of immune rejection.
    A recent publication from the Whitehead Institute reported 
that ``embryonic stem cells are actually genomically 
unstable,'' meaning that the expression of their genes is 
unstable. And this may explain the problems in achieving true 
functional differentiation of embryonic stem cells.
    It has been particularly troubling in terms of diabetes. 
Some reports suggested a fraction of embryonic stem cells could 
be stimulated to produce insulin. But those reports were called 
into question by a Harvard study that indicated the embryonic 
stem cells were not making insulin themselves, but were 
imbibing it from the culture medium in which they were grown, 
and then releasing it.
    Another recent study found that supposedly differentiated 
insulin-expressing embryonic stem cells were not actually true 
insulin-expressing cells, and, when injected into animals, 
caused tumors. Human embryonic stem cells, even the new lines, 
have been found to accumulate chromosomal abnormalities in 
culture, as well.
    Commentary in the New England Journal of Medicine noted 
significant problems still facing the potential utility of 
embryonic stem cells, quote, ``There are still many hurdles to 
clear before embryonic stem cells can be used therapeutically. 
For example, because undifferentiated embryonic stem cells can 
form tumors after transplantation, it is important to determine 
an appropriate state of differentiation before transplantation. 
Differentiation protocols for many cell types have yet to be 
established. Targeting the differentiated cells to the 
appropriate organ and the appropriate part of the organ is also 
a challenge,'' end quote.
    And the theory that cloning, or somatic cell nuclear 
transfer, will produce matching tissues for transplant that 
will not be rejected has already been shown to be incorrect. 
When tested in mice, the transplanted embryonic stem cells from 
the cloned mouse embryo were rejected by the genetically 
identical host. Even Dr. James Thompson, who was the first to 
isolate human embryonic stem cells, has stated that cloning is 
unlikely to be clinically significant. And other world leaders 
in the embryonic stem cell field, including Australia's Alan 
Trounson, have echoed this.
    Cloning also will require a tremendous number of human 
eggs, or oocytes, to produce even one embryonic stem cell line. 
One estimate is a minimum of 100 eggs per patient. The recent 
South Korean cloning of a human embryo required 242 eggs to get 
just one embryonic stem cell line.
    There have actually been few positive published scientific 
reports regarding the claims put forth for embryonic stem 
cells. The relative lack of success should be compared with the 
real success of adult stem cells. A wealth of published 
scientific papers over the last few years document that adult 
stem cells are a much more promising source of cells for 
regenerative medicine, to actually treat patients. They do, for 
example, show pluripotent capacity, meaning the capacity to 
form most, potentially all, of the tissues of the adult body. 
And this capacity has been found in cells from diverse sources, 
including bone marrow, peripheral blood, the inner ear, and 
umbilical cord blood. I've attached a chart as Appendix A to my 
written testimony that outlines some, though not all, of the 
tissues from which adult stem cells have been isolated, and 
some of the derivatives. In fact, even liposuctioned fat has 
been found to contain stem cells, which Dr. Hedrick will 
address in a moment.
    Many published references show adult stem cells can 
multiply in culture, retaining their ability to differentiate, 
and provide a sufficient numbers of cells for clinical 
treatments. Moreover, they've been found effective in treating 
animal models of disease for diseases including diabetes, 
stroke, spinal cord injury, Parkinson's disease, and retinal 
degeneration.
    Moreover, adult stem cells are already being used 
clinically for many diseases. When I say ``clinically,'' I mean 
``in patients.'' These include treatments for cancers, 
autoimmune diseases, such as multiple sclerosis, lupus, and 
arthritis, anemias, such as sickle-cell anemia, immune 
deficiencies, making new cartilage, growing new corneas to 
restore sight to blind patients, clinical trials for stroke, 
and several groups using adult stem cells with patients to 
repair damage after heart attacks. In fact, Mr. Chairman, at 
your last hearing, you heard testimony from patients treated 
with adult stem cells and receiving benefit for spinal cord 
injury and Parkinson's disease. The adult stem cells circumvent 
the problems of immune rejection, and do so without tumor 
formation.
    The mechanism is still unknown, and it's a fascinating 
area, for this regeneration. In some cases, the cells do seem 
to interconvert into other tissues. In other cases, they fuse 
with the tissue, such as liver, and take on the characteristics 
to pursue the regeneration. And, in some cases, they simply 
stimulate the cells already present in the tissues so the adult 
stem cells are not, themselves, forming the new tissue.
    But as Robert Lanza, a proponent of embryonic stem cell 
research, has noted, quote, ``There is ample scientific 
evidence that adult stem cells can be used to repair damaged 
heart or brain tissue. If it works, it works, regardless of the 
mechanism,'' end quote.
    I've given you only a sampling of citations here. I have 
attached to my written testimony a paper prepared for the 
President's Council documenting over 200 references of adult 
stem cell successes, as well as, in the Appendix B to this 
testimony, a list of approximately 54 human diseases currently 
being treated with adult stem cells.
    In summary, these adult stem cells, including umbilical-
cord blood, have been shown by the published evidence to be a 
more promising alternative for patient treatment. Adult stem 
cells have proven success, not just in the dish or in the 
animal, but also in the patients in the early clinical trials, 
and they avoid the problems with tumor formation, transplant 
rejection, and provide realistic excitement for patient 
treatment.
    Thank you.
    [The prepared statement of Dr. Prentice follows:]

 Prepared Statement of Dr. David A. Prentice, Ph.D., Senior Fellow for 
Life Sciences, Family Research Council; Affiliated Scholar, Center for 
        Clinical Bioethics, Georgetown University Medical Center
    Mr. Chairman, Distinguished Members of the Committee, thank you for 
the opportunity to provide testimony on this important subject.
    Mark Twain noted that ``There is something fascinating about 
science. One gets such wholesale returns of conjecture out of such a 
trifling investment of fact.'' This is certainly true regarding the 
hype and emotion surrounding the stem cell issue.
    We should start with some biological definitions, to provide a 
common scientific frame of reference.
    ``Almost all higher animals start their lives from a single cell, 
the fertilized ovum (zygote). . . The time of fertilization represents 
the starting point in the life history, or ontogeny, of the 
individual.'' \1\
---------------------------------------------------------------------------
    \1\ Carlson, Bruce M.; Patten's Foundations of Embryology, 6th 
edition. New York: McGraw-Hill, 1996, p. 3
---------------------------------------------------------------------------
    The quotes below are from internationally preeminent human 
embryologist Ronan O'Rahilly in his latest textbook. Dr. O'Rahilly 
originated the international Carnegie Stages of Human Embryological 
Development, used for many decades now by the International Nomina 
Embryologica (now the Terminologica Embryologica) Committee which 
determines the scientifically correct terms to be used in human 
embryology around the world.

        ``Although life is a continuous process, fertilization. . .is a 
        critical landmark because, under ordinary circumstances, a new, 
        genetically distinct human organism is formed when the 
        chromosomes of the male and female pronuclei blend in the 
        oocyte. This remains true even though the embryonic genome is 
        not actually activated until 2-8 cells are present, at about 2-
        3 days. . . During the embryonic period proper, milestones 
        include fertilization, activation of embryonic from extra-
        embryonic cells, implantation, and the appearance of the 
        primitive streak and bilateral symmetry. Despite the various 
        embryological milestones, however, development is a continuous 
        rather than a saltatory process, and hence the selection of 
        prenatal events would seem to be largely arbitrary.'' \2\
---------------------------------------------------------------------------
    \2\ Ronan O'Rahilly and Faiola Muller, ``Human Embryology & 
Teratology'', 3rd ed. New York: Wiley-Liss, 2001; p. 8

        ``Prenatal life is conveniently divided into two phases: the 
        embryonic and the fetal . . . [I]t is now accepted that the 
        word embryo, as currently used in human embryology, means `an 
        unborn human in the first 8 weeks' from fertilization. 
        Embryonic life begins with the formation of a new embryonic 
        genome (slightly prior to its activation).'' \3\
---------------------------------------------------------------------------
    \3\ Ronan O'Rahilly and Faiola Muller, ``Human Embryology & 
Teratology'', 3rd ed. New York: Wiley-Liss, 2001; p. 87

    Thus whether within the body or in the laboratory via in vitro 
fertilization or other assisted reproductive techniques, the first 
stage of development of a new individual begins with fertilization. 
Because it has become an area of interest, it is useful to point out 
that biologically the process of cloning (somatic cell nuclear 
transfer; SCNT) also produces a zygote as the starting point for 
development. As the President's Council on Bioethics has noted, ``The 
first product of SCNT is, on good biological grounds, quite properly 
regarded as the equivalent of a zygote, and its subsequent stages as 
embryonic stages in development.'' \4\ The National Academy of Sciences 
noted the following:
---------------------------------------------------------------------------
    \4\ ``Human Cloning and Human Dignity: An Ethical Inquiry'', Report 
of the President's Council on Bioethics, July 2002; p. 50

        ``The method used to initiate the reproductive cloning 
        procedure is called nuclear transplantation, or somatic cell 
        nuclear transfer (SCNT). It involves replacing the chromosomes 
        of a human egg with the nucleus of a body (somatic) cell from a 
        developed human. In reproductive cloning, the egg is then 
        stimulated to undergo the first few divisions to become an 
        aggregate of 64 to 200 cells called a blastocyst. The 
        blastocyst is a preimplantation embryo that contains some cells 
        with the potential to give rise to a fetus and other cells that 
        help to make the placenta. If the blastocyst is placed in a 
        uterus, it can implant and form a fetus. If the blastocyst is 
        instead maintained in the laboratory, cells can be extracted 
        from it and grown on their own.'' \5\
---------------------------------------------------------------------------
    \5\ Scientific and Medical Aspects of Human Reproductive Cloning, 
Report of the National Academy of Sciences and the Institute of 
Medicine, National Academy Press, Washington, DC, Jan 2002; Preface 
page xii.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Embryonic stem cells can be isolated from a blastocyst-stage embryo 
early in human development, whether produced by fertilization or by 
---------------------------------------------------------------------------
cloning (SCNT):

        ``[A]n embryonic stem cell (ES cell) is defined by its origin. 
        It is derived from the blastocyst stage of the embryo. The 
        blastocyst is the stage of embryonic development prior to 
        implantation in the uterine wall.'' \6\
---------------------------------------------------------------------------
    \6\ ``Stem Cells: Scientific Progress and Future Research 
Directions'', National Institutes of Health, June 2001; Pg. 5

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    A first question we might address is, ``Why use stem cells?'' The 
short answer is to treat degenerative diseases. In the past, infectious 
diseases were the scourge of mankind; antibiotics, vaccinations, and 
sanitation have dealt with these as killers. Today degenerative 
diseases, such as heart disease, stroke, chronic lung disease, 
Parkinson's disease, and diabetes are our main concern. These leading 
causes of death in the U.S. are common to all developed nations and are 
becoming more prevalent in developing nations. In degenerative 
diseases, it is usually only part of the organ or tissue that is 
damaged, rather than the entire organ. Stem cells are proposed to treat 
these diseases by repairing and replacing the damaged tissue.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    A stem cell has two chief characteristics: (1) it multiplies, 
maintaining a pool of stem cells, and (2) given the correct signal, it 
can differentiate into other specific cell types for use by the body. 
There are several sources of stem cells (see figure above). The two 
types which have generated the most interest are embryonic stem cells 
derived from the early embryo (5-7 days after conception), and so-
called adult stem cells which reside in most, if not all, tissues of 
the body. Embryonic stem cells were first isolated in mice in 1981, and 
in humans in 1998; adult stem cells were first identified in bone 
marrow in the 1960s, and in recent years have been found in a wide 
range of tissues throughout the body. Adult stem cells are actually 
present in the tissues of the individual from the moment of birth, and 
could more properly be termed tissue stem cells, post-natal stem cells, 
or non-embryonic stem cells, and include umbilical cord blood stem 
cells and placental stem cells.
    Embryonic stem cells are derived by removing the inner cell mass of 
the early human embryo (the blastocyst); in this process, the embryo is 
destroyed. The cells are placed into culture, and their purported 
advantages are that they can proliferate indefinitely, and can form any 
tissue. Scientific publications support the claim that they can 
proliferate for long periods of time in culture. In theory they can 
form any tissue; however, the experimental basis of their potential to 
form any tissue relies on the cells being within the normal 
developmental context of the embryo, where they form the range of 
tissues and organs of the human body during normal development.
    While embryonic stem cells might seem to have a theoretical 
advantage over adult stem cells, the published literature shows that 
the claims for embryonic stem cell advantages over adult stem cells are 
thus far unsubstantiated. Indeed, the National Institutes of Health has 
noted that: ``Thus, at this stage, any therapies based on the use of 
human ES cells are still hypothetical and highly experimental.'' \7\ 
And also ``Whether embryonic stem cells will provide advantages over 
stem cells derived from cord blood or adult bone marrow hematopoietic 
stem cells remains to be determined.'' \8\
---------------------------------------------------------------------------
    \7\ National Institutes of Health, ``Stem cells: Scientific 
progress and future directions'', June 2001; p. 17.
    \8\ National Institutes of Health, ``Stem cells: Scientific 
progress and future directions'', June 2001; p. 63.
---------------------------------------------------------------------------
    There are no current clinical treatments based on embryonic stem 
cells, and there are in fact only few and modest published successes 
using animal models of disease. Those who work with embryonic stem 
cells even have difficulty obtaining pure cultures of specific cell 
types in the laboratory dish. For example, an Israeli group reported in 
2001 that they had obtained insulin-secreting cells from human 
embryonic stem cells.\9\ While this report was seized on by the press 
as a potential treatment for diabetes, what was not reported, and what 
was revealed by the scientific paper, was that only 1 percent of the 
cells in the culture dish supposedly made insulin. The remaining 99 
percent of the cells were a mixture of other cell types, including 
nerve, muscle, a few beating heart cells, and also cells which 
continued to proliferate. In fact, those growing cells point out 
another problem with embryonic stem cells--the potential for tumor 
formation.\10\ Embryonic stem cells have a distinct tendency to run out 
of control.
---------------------------------------------------------------------------
    \9\ Assady S et al., Insulin production by human embryonic stem 
cells, Diabetes 50, 1691-1697, Aug 2001.
    \10\ Wakitani S et al.; ``Embryonic stem cells injected into the 
mouse knee joint form teratomas and subsequently destroy the joint''; 
Rheumatology 42, 162-165; January 2003.
---------------------------------------------------------------------------
    Embryonic stem cells are actually difficult to establish and 
maintain in culture. James Thompson, who originated the first human 
embryonic stem cells in 1998, required 36 human embryos to finally 
obtain just 5 stem cell lines. Each stem cell line derives from one 
embryo. The Jones Institute in Virginia, in the summer of 2001, used 
110 human embryos to derive 3 stem cell lines. And in the spring of 
2004, a Harvard group used 342 human embryos to obtain 17 stem cell 
lines. In addition, embryonic stem cells face a significant risk of 
immune rejection. Tissue formed from embryonic stem cells will thus be 
rejected like most organ transplants without a precise tissue match. 
Indeed, a group from the Whitehead Institute reported that embryonic 
stem cells are actually genomically unstable, meaning that the 
expression of their genes is unstable: ``The epigenetic state of the 
embryonic stem cell genome was found to be extremely unstable.'' \11\ 
This might in fact explain why there is such difficulty in obtaining 
pure cultures and why they tend to form tumors. This may also explain 
the problems in achieving true functional differentiation of embryonic 
stem cells. This has been particularly troubling with regards to 
diabetes. While some reports have suggested that a fraction of 
embryonic stem cells could be stimulated to produce insulin, those 
reports were called into question by a Harvard study that indicated the 
embryonic stem cells were not making insulin themselves, but were 
imbibing it from the culture medium in which they were grown and then 
releasing it.\12\ Another recent study found that supposedly 
differentiated insulin-expressing embryonic stem cells were not 
actually true beta cells, and when injected into animals caused 
tumors.\13\ Human embryonic stem cells (even new lines) have been found 
to accumulate chromosomal abnormalities in culture as well.\14\ \15\
---------------------------------------------------------------------------
    \11\ Humpherys S et al.; ``Epigenetic instability in ES cells and 
cloned mice''; Science 293, 95-97; 6 July 2001.
    \12\ Rajagopal J et al.; ``Insulin staining of ES cell progeny from 
insulin uptake''; Science 299, 363; 17 Jan 2003.
    \13\ Sipione S et al., ``Insulin expressing cells from 
differentiated embryonic stem cells are not beta cells'', Diabetologia 
47, 499-508, 2004 (published online 14 Feb 2004).
    \14\ Cowan CA et al., ``Derivation of embryonic stem cell lines 
from human blastocysts'', New England Journal of Medicine 350, 1353-
1356, 25 March 2004; published online 3 March 2004.
    \15\ Draper JS et al., ``Recurrent gain of chromosomes 17q and 12 
in cultured human embryonic stem cells'', Nature Biotechnology 22, 53-
54; January 2004.
---------------------------------------------------------------------------
    It is illustrative to examine some quotes from proponents of 
embryonic stem cell research. In a review paper co-authored by James 
Thompson,\16\ the following statements are noteworthy:
---------------------------------------------------------------------------
    \16\ Odorico JS, Kaufman DS, Thomson JA, ``Multilineage 
differentiation from human embryonic stem cell lines,'' Stem Cells 19, 
193-204; 2001.

        ``Rarely have specific growth factors or culture conditions led 
---------------------------------------------------------------------------
        to establishment of cultures containing a single cell type.''

        ``Furthermore, there is significant culture-to-culture 
        variability in the development of a particular phenotype under 
        identical growth factor conditions.''

        ``[T]he possibility arises that transplantation of 
        differentiated human ES cell derivatives into human recipients 
        may result in the formation of ES cell-derived tumors.''

        ``[T]he poor availability of human oocytes, the low efficiency 
        of the nuclear transfer procedure, and the long population-
        doubling time of human ES cells make it difficult to envision 
        this [generation of human embryos by nuclear reprogramming] 
        becoming a routine clinical procedure . . .''

    Other researchers have noted similar problems with embryonic stem 
cells:

        ``The work presented here shows that none of the eight growth 
        factors tested directs a completely uniform and singular 
        differentiation of cells.'' \17\
---------------------------------------------------------------------------
    \17\ Schuldiner M et al.; ``Effects of eight growth factors on the 
differentiation of cells derived from human embryonic stem cells''; 
Proc. Natl. Acad. Sci. USA 97, 11307-11312; Oct. 10, 2000.

        ``Transplanted ES cells spontaneously differentiate into any of 
        a variety of ectodermal, endodermal and mesodermal cell types--
        sometimes into a disorganized mass of neurons, cartilage and 
        muscle; sometimes into teratomas containing an eye, hair or 
        even teeth.'' \18\
---------------------------------------------------------------------------
    \18\ Robert P. Lanza, Jose B. Cibelli, & Michael D. West; ``Human 
therapeutic cloning''; Nature Medicine 5, 975-977; September 1999

    A commentary in the journal Science included the following:\19\
---------------------------------------------------------------------------
    \19\ Vogel G, ``Can Adult Stem Cells Suffice?'', Science 292, 1820-
1822, June 8, 2001

        ``[M]urine ES cells have a disturbing ability to form tumors, 
        and researchers aren't yet sure how to counteract that. And so 
        far reports of pure cell populations derived from either human 
        or mouse ES cells are few and far between--fewer than those 
        from adult cells.'' ``Bone marrow stem cells can probably form 
---------------------------------------------------------------------------
        any cell type,'' says Harvard's [Douglas] Melton.

    And a commentary in the New England Journal of Medicine noted the 
significant problems still facing potential utility of embryonic stem 
cells:\20\
---------------------------------------------------------------------------
    \20\ Phimister EG and Drazen JM, ``Two fillips for human embryonic 
stem cells,'' New England Journal of Medicine 350, 1351-1352, 25 March 
2004 (published online 3 March 2004).

        ``There are still many hurdles to clear before embryonic stem 
        cells can be used therapeutically. For example, because 
        undifferentiated embryonic stem cells can form tumors after 
        transplantation in histocompatible animals, it is important to 
        determine an appropriate state of differentiation before 
        transplantation. Differentiation protocols for many cell types 
        have yet to be established. Targeting the differentiated cells 
        to the appropriate organ and the appropriate part of the organ 
---------------------------------------------------------------------------
        is also a challenge.''

    Furthermore, the theory that cloning (SCNT) will produce matching 
tissues for transplant that will not be rejected has already been shown 
incorrect. When tested in mice,\21\ the ES cells from the cloned mouse 
embryo were rejected by the genetically-identical host:
---------------------------------------------------------------------------
    \21\ Rideout WM et al., ``Correction of a genetic defect by nuclear 
transplantation and combined cell and gene therapy,'' Cell 109, 17-27; 
5 April 2002 (published online 8 March 2002).

        ``Jaenisch addressed the possibility that ES clones derived by 
        nuclear transfer technique could be used to correct genetic 
        defects . . . However, the donor cells, although derived from 
        the animals with the same genetic background, are rejected by 
        the hosts.'' \22\
---------------------------------------------------------------------------
    \22\ Tsai RYL, Kittappa R, and McKay RDG; ``Plasticity, niches, and 
the use of stem cells''; Developmental Cell 2, 707-712; June 2002.

    As noted above, Dr. James Thomson has stated that cloning is 
unlikely to be clinically significant. Other leaders in the embryonic 
stem cell field have also published similar views, including 
Australia's Alan Trounson:\23\
---------------------------------------------------------------------------
    \23\ Trounson AO, ``The derivation and potential use of human 
embryonic stem cells'', Reproduction, Fertility, and Development 13, 
523-532; 2001

        ``However, it is unlikely that large numbers of mature human 
        oocytes would be available for the production of ES cells, 
        particularly if hundreds are required to produce each ES line . 
        . . In addition, epigenetic remnants of the somatic cell used 
        as the nuclear donor can cause major functional problems in 
        development, which must remain a concern for ES cells derived 
        by nuclear transfer . . . it would appear unlikely that these 
        strategies will be used extensively for producing ES cells 
---------------------------------------------------------------------------
        compatible for transplantation.''

    The evidence from animal studies indicates that it will indeed 
require a tremendous number of human oocytes to produce even one ES 
line from cloned embryos. Dr. Peter Mombaerts, who was one of the first 
mouse cloners, estimates that it will require a minimum of 100 
eggs.\24\ The reported first cloning of a human embryo in South Korea 
this year actually required 242 eggs to obtain just one ES cell 
line.\25\
---------------------------------------------------------------------------
    \24\ Mombaerts P, ``Therapeutic cloning in the mouse'', Proceedings 
of the National Academy of Sciences USA 100, 11924-11925; 30 Sept. 2003 
(published online 29 August 2003).
    \25\ Hwang WS et al., ``Evidence of a pluripotent human embryonic 
stem cell line derived from a cloned blastocyst'', Science 303, 1669-
1674; 12 March 2004 (published online 12 Feb. 2004).
---------------------------------------------------------------------------
    There are in truth few actual positive published scientific reports 
regarding the claims put forth for embryonic stem cells, and a 
significant number of negative characteristics. At present embryonic 
stem cells have shown modest success in repairing spinal cord damage 
\26\ and Parkinson's disease,\27\ though the latter experiments showed 
significant tumor formation in the animals. The theoretical potential 
of embryonic stem cells to treat diseases, and the theoretical ability 
to control their differentiation without tumor formation, is wishful 
thinking.
---------------------------------------------------------------------------
    \26\ McDonald JW et al., ``Transplanted embryonic stem cells 
survive, differentiate and promote recovery in injured rat spinal 
cord,'' Nature Medicine 12, 1410-1412, Dec 1999; Liu S et al., 
``Embryonic stem cells differentiate into oligodendrocytes and 
myelinate in culture and after spinal cord transplantation,'' Proc. 
Natl. Acad. Sci. USA 97, 6126-6131; 23 May 2000; Brustle O et al., 
``Embryonic Stem Cell-Derived Glial Precursers: A Source of Myelinating 
Transplants,'' Science 285, 754-756, 30 July 1999.
    \27\ Nishimura F et al.; ``Potential use of embryonic stem cells 
for the treatment of mouse Parkinsonian models: improved behavior by 
transplantation of in vitro differentiated dopaminergic neurons from 
embryonic stem cells''; Stem Cells 21, 171-180; March 2003; Bjorklund 
LM et al.; ``Embryonic stem cells develop into functional dopaminergic 
neurons after transplantation in a Parkinson rat model,'' Proc. Natl. 
Acad. Sci.USA 99, 2344-2349; 19 Feb 2002.
---------------------------------------------------------------------------
    The relative lack of success of embryonic stem cells should be 
compared with the real success of adult stem cells. A wealth of 
scientific papers published over the last few years document that adult 
stem cells are a much more promising source of stem cells for 
regenerative medicine. Adult stem cells actually do show pluripotent 
capacity in generation of tissues, meaning that they can generate most, 
if not all, tissues of the body. In a paper published in May 2001, the 
researchers found that one adult bone marrow stem cell could regenerate 
not only marrow and blood, but also form liver, lung, digestive tract, 
skin, heart, muscle.\28\ Other researchers have found pluripotent 
ability of adult stem cells various sources including from bone 
marrow,\29\ \30\ peripheral blood,\31\ inner ear,\32\ and umbilical 
cord blood.\33\
---------------------------------------------------------------------------
    \28\ Krause DS et al.; ``Multi-Organ, Multi-Lineage Engraftment by 
a Single Bone Marrow-Derived Stem Cell''; Cell 105, 369-377; 4 May 
2001.
    \29\ Jiang Y et al.; ``Pluripotency of mesenchymal stem cells 
derived from adult marrow''; Nature 418, 41-49; 4 July 2002.
    \30\ D'Ippolito G et al., ``Marrow-isolated adult multilineage 
inducible (MIAMI) cells, a unique population of postnatal young and old 
human cells with extensive expansion and differentiation potential'', 
J. Cell Science 117, 2971-2981, 15 July 2004 (published online 1 June 
2004).
    \31\ Zhao Y et al.; ``A human peripheral blood monocyte-derived 
subset acts as pluripotent stem cells''; Proceedings of the National 
Academy of Sciences USA 100, 2426-2431; 4 March 2003.
    \32\ Li H et al., ``Pluripotent stem cells from the adult mouse 
inner ear'', Nature Medicine 9, 1293-1299, October 2003.
    \33\ Kogler G et al., ``A new human somatic stem cell from 
placental cord blood with intrinsic pluripotent differentiation 
potential'', J. Experimental Medicine 200, 123-135, 19 July 2004.
---------------------------------------------------------------------------
    The chart attached as Appendix A shows examples (not all-inclusive) 
of tissues from which adult stem cells have been isolated, as well as 
some of the derivatives from those stem cells. Bone marrow stem cells 
seem particularly ``plastic'', potentially with the ability to form all 
adult tissues. Even liposuctioned fat has been found to contain stem 
cells which can be transformed into other tissues. In point of fact, 
any time someone has looked in a tissue for stem cells, they have found 
them.
    Many published references also show that adult stem cells can 
multiply in culture for extensive periods of time, retaining their 
ability to differentiate, and providing sufficient numbers of cells for 
clinical treatments. More importantly, adult stem cells have been shown 
to be effective in treating animal models of disease, including such 
diseases as diabetes,\34\ stroke,\35\ spinal cord injury,\36\ 
Parkinson's disease,\37\ and retinal degeneration.\38\
---------------------------------------------------------------------------
    \34\ Oh S-H et al., ``Adult bone marrow-derived cells 
transdifferentiating into insulin-producing cells for the treatment of 
type I diabetes,'' Laboratory Investigation published online 22 March 
2004; Kodama S et al., ``Islet regeneration during the reversal of 
autoimmune diabetes in NOD mice'', Science 302, 1223-1227; 14 Nov 2003; 
Hess D et al., ``Bone marrow-derived stem cells initiate pancreatic 
regeneration'', Nature Biotechnology 21, 763-770; July 2003.
    \35\ Willing AE et al., ``Mobilized peripheral blood stem cells 
administered intravenously produce functional recovery in stroke'', 
Cell Transplantation 12, 449-454; 2003; Arvidsson A et al.; ``Neuronal 
replacement from endogenous precursors in the adult brain after 
stroke''; Nature Medicine 8, 963-970; Sept 2002; Riess P et al.; 
``Transplanted neural stem cells survive, differentiate, and improve 
neurological motor function after experimental traumatic brain 
injury''; Neurosurgery 51, 1043-1052; Oct 2002.
    \36\ Hofstetter CP et al., ``Marrow stromal cells form guiding 
strands in the injured spinal cord and promote recovery'', Proc Natl 
Acad Sci USA 99, 2199-2204; 19 February 2002; Sasaki M et al., 
``Transplantation of an acutely isolated bone marrow fraction repairs 
demyelinated adult rat spinal cord axons,'' Glia 35, 26-34; July 2001; 
Ramon-Cueto A et al., ``Functional recovery of paraplegic rats and 
motor axon regeneration in their spinal cords by olfactory ensheathing 
glia,'' Neuron 25, 425-435; February 2000.
    \37\ Liker MA et al.; ``Human neural stem cell transplantation in 
the MPTP-lesioned mouse''; Brain Research 971, 168-177; May 2003; 
Akerud P et al.; ``Persephin-overexpressing neural stem cells regulate 
the function of nigral dopaminergic neurons and prevent their 
degeneration in a model of Parkinson's disease''; Molecular and 
Cellular Neuroscience 21, 205-222; Nov. 2002; Ourednik J et al.; 
``Neural stem cells display an inherent mechanism for rescuing 
dysfunctional neurons''; Nature Biotechnology 20, 1103-1110; Nov. 2002.
    \38\ Otani A et al., ``Rescue of retinal degeneration by 
intravitreally injected adult bone marrow-derived lineage-negative 
hematopoietic stem cells'', J. Clinical Investigation 114, 765-774, 
September 2004; Otani A et al., ``Bone marrow derived stem cells target 
retinal astrocytes and can promotes or inhibit retinal angiogenesis''; 
Nature Medicine 8, 1004-1010; Sept. 2002; Tomita M et al., ``Bone 
marrow derived stem cells can differentiate into retinal cells in 
injured rat retina''; Stem Cells 20, 279-283; 2002.
---------------------------------------------------------------------------
    Moreover, adult stem cells are already being used clinically for 
many diseases. These include as reparative treatments with various 
cancers, autoimmune diseases such as multiple sclerosis, lupus, and 
arthritis, anemias including sickle cell anemia, and 
immunodeficiencies. Adult stem cells are also being used to treat 
patients by formation of cartilage, growing new corneas to restore 
sight to blind patients, treatments for stroke, and several groups are 
using adult stem cells with patients to repair damage after heart 
attacks. Early clinical trials have shown initial success in patient 
treatments for Parkinson's disease and spinal cord injury. An advantage 
of using adult stem cells is that in most cases the patient's own stem 
cells can be used for the treatment, circumventing the problems of 
immune rejection, and without tumor formation.
    The mechanism for these amazing regenerative treatments is still 
unclear. Adult stem cells in some cases appear capable of 
interconversion between different tissue types, known as 
transdifferentiation. In some tissues, adult stem cells appear to fuse 
with the host tissue and take on that tissue's characteristics, 
facilitating regeneration. And in some studies, the adult stem cells do 
not directly contribute to the regenerating tissue, but instead appear 
to stimulate the endogenous cells of the tissue to begin repair. 
Whatever the mechanism, the adult cells are successful at regenerating 
damaged tissue. As Robert Lanza, a proponent of embryonic stem cells 
and cloning has noted, ``there is ample scientific evidence that adult 
stem cells can be used to repair damaged heart or brain tissue . . . if 
it works, it works, regardless of the mechanism.'' \39\ The citations 
given above for adult stem cells are only a sampling, including some 
more recent references. A representative list of diseases currently in 
patient clinical trials with adult stem cells is given as Appendix B. A 
more complete review of the recent adult stem cell literature is 
appended at the end, as a paper prepared for the President's Council on 
Bioethics in 2003 (see: http://bioethics.georgetown.edu/pcbe/reports/
stemcell/appendix_k.html).
---------------------------------------------------------------------------
    \39\ Steve Mitchell, ``Study casts doubt on adult stem cells'', 
UPI; 12 October 2003.
---------------------------------------------------------------------------
    In summary, adult stem cells have been shown by the published 
evidence to be a more promising alternative for patient treatments, 
with a vast biomedical potential. Adult stem cells have proven success 
in the laboratory dish, in animal models of disease, and in current 
clinical treatments. Adult stem cells also avoid problems with tumor 
formation, transplant rejection, and provide realistic excitement for 
patient treatments.
    Mr. Chairman, Distinguished Members, thank you once again for 
allowing me to present testimony on this issue.
                               Appendix A
    Post-Natal (non-embryonic) Stem Cells and their Known or Possible 
Derivatives
    (not an all-inclusive list)
    (From the peer-reviewed scientific literature; for placenta by 
company press releases)

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                               Appendix B
           CURRENT CLINICAL APPLICATIONS OF ADULT STEM CELLS 
                        (not a complete listing)
              ADULT STEM CELLS--HEMATOPOIETIC REPLACEMENT
                                CANCERS
BRAIN TUMORS--medulloblastoma and glioma
Dunkel, IJ; ``High-dose chemotherapy with autologous stem cell rescue 
            for malignant brain tumors''; Cancer Invest. 18, 492-493; 
            2000.
Abrey, LE et al.; ``High dose chemotherapy with autologous stem cell 
            rescue in adults with malignant primary brain tumors''; J. 
            Neurooncol. 44, 147-153; Sept., 1999
Finlay, JL; ``The role of high-dose chemotherapy and stem cell rescue 
            in the treatment of malignant brain tumors: a 
            reappraisal''; Pediatr. Transplant 3 Suppl. 1, 87-95; 1999

RETINOBLASTOMA
Hertzberg H et al.; ``Recurrent disseminated retinoblastoma in a 7-
            year-old girl treated successfully by high-dose 
            chemotherapy and CD34-selected autologous peripheral blood 
            stem cell transplantation''; Bone Marrow Transplant 27(6), 
            653-655; March 2001
Dunkel IJ et al.; ``Successful treatment of metastatic 
            retinoblastoma''; Cancer 89, 2117-2121; Nov 15 2000

OVARIAN CANCER
Stiff PJ et al.; ``High-dose chemotherapy and autologous stem cell 
            transplantation for ovarian cancer: An autologous blood and 
            marrow transplant registry report''; Ann. Intern. Med. 133, 
            504-515; Oct. 3, 2000
Schilder, RJ and Shea, TC; ``Multiple cycles of high-dose chemotherapy 
            for ovarian cancer''; Semin. Oncol. 25, 349-355; June 1998

MERKEL CELL CARCINOMA
Waldmann V et al.; ``Transient complete remission of metastasized 
            merkel cell carcinoma by high-dose polychemotherapy and 
            autologous peripheral blood stem cell transplantation''; 
            Br. J. Dermatol. 143, 837-839; Oct 2000

TESTICULAR CANCER
Bhatia S et al.; ``High-dose chemotherapy as initial salvage 
            chemotherapy in patients with relapsed testicular cancer''; 
            J. Clin. Oncol. 18, 3346-3351; Oct. 19, 2000
Hanazawa, K et al.; ``Collection of peripheral blood stem cells with 
            granulocyte-colony-stimulating factor alone in testicular 
            cancer patients''; Int. J. Urol. 7, 77-82; March 2000.

LYMPHOMA
Tabata M et al.; ``Peripheral blood stem cell transplantation in 
            patients over 65 years old with malignant lymphoma--
            possibility of early completion of chemotherapy and 
            improvement of performance status''; Intern Med 40, 471-
            474; June 2001
Josting, A; ``Treatment of Primary Progressive Hodgkin's and Aggressive 
            Non-Hodgkin's Lymphoma: Is There a Chance for Cure?''; J 
            Clin Oncol 18, 332-339; 2000
Koizumi M et al.; ``Successful treatment of intravascular malignant 
            lymphomatosis with high-dose chemotherapy and autologous 
            peripheral blood stem cell transplantation''; Bone Marrow 
            Transplant 27, 1101-1103; May 2001

ACUTE LYMPHOBLASTIC LEUKEMIA
Ohnuma K et al.; ``Cord blood transplantation from HLA-mismatched 
            unrelated donors as a treatment for children with 
            haematological malignancies''; Br J Haematol 112(4), 981-
            987; March 2001
Marco F et al.; ``High Survival Rate in Infant Acute Leukemia Treated 
            With Early High-Dose Chemotherapy and Stem Cell Support''; 
            J Clin Oncol 18, 3256-3261; Sept. 15 2000

ACUTE MYELOGENOUS LEUKEMIA
Ohnuma K et al.; ``Cord blood transplantation from HLA-mismatched 
            unrelated donors as a treatment for children with 
            haematological malignancies''; Br J Haematol 112(4), 981-
            987; March 2001
Gorin NC et al.; ``Feasibility and recent improvement of autologous 
            stem cell transplantation for acute myelocytic leukaemia in 
            patients over 60 years of age: importance of the source of 
            stem cells''; Br. J. Haematol. 110, 887-893; Sept 2000
Bruserud O et al.; ``New strategies in the treatment of acute 
            myelogenous leukemia: mobilization and transplantation of 
            autologous peripheral blood stem cells in adult patients''; 
            Stem Cells 18, 343-351; 2000

CHRONIC MYELOGENOUS LEUKEMIA
Ohnuma K et al.; ``Cord blood transplantation from HLA-mismatched 
            unrelated donors as a treatment for children with 
            haematological malignancies''; Br J Haematol 112(4), 981-
            987; March 2001

JUVENILE MYELOMONOCYTIC LEUKEMIA
Ohnuma K et al.; ``Cord blood transplantation from HLA-mismatched 
            unrelated donors as a treatment for children with 
            haematological malignancies''; Br J Haematol 112(4), 981-
            987; March 2001

ANGIOIMMUNOBLASTIC LYMPHADENOPATHY with DYSPROTEINEMIA
Lindahl J et al.; ``High-dose chemotherapy and APSCT as a potential 
            cure for relapsing hemolysing AILD''; Leuk Res 25(3), 267-
            270; March 2001

MULTIPLE MYELOMA
Laughlin MJ et al.; ``Hematopoietic engraftment and survival in adult 
            recipients of umbilical-cord blood from unrelated donors'', 
            New England Journal of Medicine 344, 1815-1822; June 14, 
            2001
Vesole, DH et al.; ``High-Dose Melphalan With Autotransplantation for 
            Refractory Multiple Myeloma: Results of a Southwest 
            Oncology Group Phase II Trial''; J Clin Oncol 17, 2173-
            2179; July 1999.

MYELODYSPLASIA
Ohnuma K et al.; ``Cord blood transplantation from HLA-mismatched 
            unrelated donors as a treatment for children with 
            haematological malignancies''; Br J Haematol 112(4), 981-
            987; March 2001
Bensinger WI et al.; ``Transplantation of bone marrow as compared with 
            peripheral-blood cells from HLA-identical relatives in 
            patients with hematologic cancers''; New England Journal of 
            Medicine 344, 175-181; Jan 18 2001

BREAST CANCER
Damon LE et al.; ``High-dose chemotherapy and hematopoietic stem cell 
            rescue for breast cancer: experience in California''; Biol. 
            Blood Marrow Transplant 6, 496-505; 2000
Paquette, RL et al., ``Ex vivo expanded unselected peripheral blood: 
            progenitor cells reduce posttransplantation neutropenia, 
            thrombocytopenia, and anemia in patients with breast 
            cancer'', Blood 96, 2385-2390; October, 2000.
Stiff P et al.; ``Autologous transplantation of ex vivo expanded bone 
            marrow cells grown from small aliquots after high-dose 
            chemotherapy for breast cancer''; Blood 95, 2169-2174; 
            March 15, 2000
Koc, ON et al.; ``Rapid Hematopoietic Recovery After Coinfusion of 
            Autologous-Blood Stem Cells and Culture-Expanded Marrow 
            Mesenchymal Stem Cells in Advanced Breast Cancer Patients 
            Receiving High-Dose Chemotherapy''; J Clin Oncol 18, 307-
            316; January 2000

NEUROBLASTOMA
Kawa, K et al.; ``Long-Term Survivors of Advanced Neuroblastoma With 
            MYCN Amplification: A Report of 19 Patients Surviving 
            Disease-Free for More Than 66 Months''; J Clin Oncol 
            17:3216-3220; October 1999

NON-HODGKIN'S LYMPHOMA
Tabata M et al.; ``Peripheral blood stem cell transplantation in 
            patients over 65 years old with malignant lymphoma--
            possibility of early completion of chemotherapy and 
            improvement of performance status''; Intern Med 40, 471-
            474; June 2001
Josting, A; ``Treatment of Primary Progressive Hodgkin's and Aggressive 
            Non-Hodgkin's Lymphoma: Is There a Chance for Cure?''; J 
            Clin Oncol 18, 332-339; 2000
Kirita T et al.; ``Primary non-Hodgkin's lymphoma of the mandible 
            treated with radiotherapy, chemotherapy, and autologous 
            peripheral blood stem cell transplantation''; Oral Surg 
            Oral Med Oral Pathol Oral Radiol Endod. 90, 450-455; Oct. 
            2000
Yao M et al.; ``Ex vivo expansion of CD34-positive peripheral blood 
            progenitor cells from patients with non-Hodgkin's lymphoma: 
            no evidence of concomitant expansion of contaminating bcl2/
            JH-positive lymphoma cells''; Bone Marrow Transplant 26, 
            497-503; Sept. 2000

HODGKIN'S LYMPHOMA
Josting, A; ``Treatment of Primary Progressive Hodgkin's and Aggressive 
            Non-Hodgkin's Lymphoma: Is There a Chance for Cure?''; J 
            Clin Oncol 18, 332-339; 2000

RENAL CELL CARCINOMA
Childs R et al., ``Regression of Metastatic Renal-Cell Carcinoma after 
            Nonmyeloablative Allogeneic Peripheral-Blood Stem Cell 
            Transplantation'', New England Journal of Medicine 343, 
            750-758; Sept. 14, 2000
Childs, RW; ``Successful Treatment of Metastatic Renal Cell Carcinoma 
            With a Nonmyeloablative Allogeneic Peripheral-Blood 
            Progenitor-Cell Transplant: Evidence for a Graft-Versus-
            Tumor Effect:; J Clin Oncol 17, 2044-2049; July 1999

VARIOUS SOLID TUMORS
Nieboer P et al.; ``Long-term haematological recovery following high-
            dose chemotherapy with autologous bone marrow 
            transplantation or peripheral stem cell transplantation in 
            patients with solid tumours''; Bone Marrow Transplant 27, 
            959-966; May 2001
Lafay-Cousin L et al.; ``High-dose thiotepa and hematopoietic stem cell 
            transplantation in pediatric malignant mesenchymal tumors: 
            a phase II study''; Bone Marrow Transplant 26, 627-632; 
            Sept. 2000
Michon, J and Schleiermacher, G. ``Autologous haematopoietic stem cell 
            transplantation for paediatric solid tumors'', Baillieres 
            Best Practice Research in Clinical Haematology 12, 247-259, 
            March-June, 1999.
Schilder, RJ et al.; ``Phase I trial of multiple cycles of high-dose 
            chemotherapy supported by autologous peripheral-blood stem 
            cells''; J. Clin. Oncol. 17, 2198-2207; July 1999

SOFT TISSUE SARCOMA
Blay JY et al.; ``High-dose chemotherapy with autologous hematopoietic 
            stem cell transplantation for advanced soft tissue sarcoma 
            in adults''; J. Clin. Oncol. 18, 3643-3650; Nov 1 2000
              ADULT STEM CELLS--IMMUNE SYSTEM REPLACEMENT
                          AUTOIMMUNE DISEASES
SCLEROMYXEDEMA
Feasel et al., ``Complete remission of scleromyxedema following 
            autologous stem cell transplantation,'' Archives of 
            Dermatology 137, 1071-1072; Aug. 2001.

MULTIPLE SCLEROSIS
Mancardi GL et al.; ``Autologous hematopoietic stem cell 
            transplantation suppresses Gd-enhanced MRI activity in 
            MS''; Neurology 57, 62-68; July 10, 2001
Rabusin M et al.; ``Immunoablation followed by autologous hematopoietic 
            stem cell infusion for the treatment of severe autoimmune 
            disease''; Haematologica 85(11 Suppl), 81-85; Nov. 2000
Burt, RK and Traynor, AE; ``Hematopoietic Stem Cell Transplantation: A 
            New Therapy for Autoimmune Disease''; Stem Cells17, 366-
            372; 1999
Burt RK et al.; ``Hematopoietic stem cell transplantation of multiple 
            sclerosis, rheumatoid arthritis, and systemic lupus 
            erythematosus''; Cancer Treat. Res. 101, 157-184; 1999

CROHN'S DISEASE
Burt RK et al., ``High-dose immune suppression and autologous 
            hematopoietic stem cell transplantation in refractory Crohn 
            disease'', Blood 101, 2064-2066, March 2003
Rabusin M et al.; ``Immunoablation followed by autologous hematopoietic 
            stem cell infusion for the treatment of severe autoimmune 
            disease''; Haematologica 85(11 Suppl), 81-85; Nov. 2000
Hawkey CJ et al.; ``Stem cell transplantation for inflammatory bowel 
            disease: practical and ethical issues''; Gut 46, 869-872; 
            June 2000

RHEUMATOID ARTHRITIS
Burt RK et al., ``Induction of remission of severe and refractory 
            rheumatoid arthritis by allogeneic mixed chimerism'', 
            Arthritis & Rheumatism 50, 2466-2470, August 2004
Verburg RJ et al.; ``High-dose chemotherapy and autologous 
            hematopoietic stem cell transplantation in patients with 
            rheumatoid arthritis: results of an open study to assess 
            feasibility, safety, and efficacy''; Arthritis Rheum 44(4), 
            754-760; April 2001
Rabusin M et al.; ``Immunoablation followed by autologous hematopoietic 
            stem cell infusion for the treatment of severe autoimmune 
            disease''; Haematologica 85(11 Suppl), 81-85; Nov. 2000
Burt, RK and Traynor, AE; ``Hematopoietic Stem Cell Transplantation: A 
            New Therapy for Autoimmune Disease''; Stem Cells17, 366-
            372; 1999
Burt RK et al.; ``Hematopoietic stem cell transplantation of multiple 
            sclerosis, rheumatoid arthritis, and systemic lupus 
            erythematosus''; Cancer Treat. Res. 101, 157-184; 1999
Burt, RK et al., ``Autologous hematopoietic stem cell transplantation 
            in refractory rheumatoid arthritis: sustained response in 
            two of four patients'', Arthritis & Rheumatology 42, 2281-
            2285, November, 1999.

JUVENILE ARTHRITIS
Rabusin M et al.; ``Immunoablation followed by autologous hematopoietic 
            stem cell infusion for the treatment of severe autoimmune 
            disease''; Haematologica 85(11 Suppl), 81-85; Nov. 2000
Burt, RK and Traynor, AE; ``Hematopoietic Stem Cell Transplantation: A 
            New Therapy for Autoimmune Disease''; Stem Cells17, 366-
            372; 1999

SYSTEMIC LUPUS
Wulffraat NM et al.; ``Prolonged remission without treatment after 
            autologous stem cell transplantation for refractory 
            childhood systemic lupus erythematosus''; Arthritis Rheum 
            44(3), 728-731; March 2001
Rosen O et al.; ``Autologous stem cell transplantation in refractory 
            autoimmune diseases after in vivo immunoablation and ex 
            vivo depletion of mononuclear cells''; Arthritis res. 2, 
            327-336; 2000
Traynor AE et al.; ``Treatment of severe systemic lupus erythematosus 
            with high-dose chemotherapy and haemopoietic stem cell 
            transplantation: a phase I study''; Lancet 356, 701-707; 
            August 26, 2000
Burt, RK and Traynor, AE; ``Hematopoietic Stem Cell Transplantation: A 
            New Therapy for Autoimmune Disease''; Stem Cells17, 366-
            372; 1999
Burt RK et al.; ``Hematopoietic stem cell transplantation of multiple 
            sclerosis, rheumatoid arthritis, and systemic lupus 
            erythematosus''; Cancer Treat. Res. 101, 157-184; 1999
Traynor A and Burt RK; ``Haematopoietic stem cell transplantation for 
            active systemic lupus erythematosus''; Rheumatology 38, 
            767-772; August 1999
Martini A et al.; ``Marked and sustained improvement 2 years after 
            autologous stem cell transplant in a girl with system 
            sclerosis''; Rheumatology 38, 773; August 1999

POLYCHONDRITIS
Rosen O et al.; ``Autologous stem cell transplantation in refractory 
            autoimmune diseases after in vivo immunoablation and ex 
            vivo depletion of mononuclear cells''; Arthritis res. 2, 
            327-336; 2000

SYSTEMIC VASCULITIS
Rabusin M et al.; ``Immunoablation followed by autologous hematopoietic 
            stem cell infusion for the treatment of severe autoimmune 
            disease''; Haematologica 85(11 Suppl), 81-85; Nov. 2000

SJOGREN'S SYNDROME
Rabusin M et al.; ``Immunoablation followed by autologous hematopoietic 
            stem cell infusion for the treatment of severe autoimmune 
            disease''; Haematologica 85(11 Suppl), 81-85; Nov. 2000

BEHCET'S DISEASE
Rabusin M et al.; ``Immunoablation followed by autologous hematopoietic 
            stem cell infusion for the treatment of severe autoimmune 
            disease''; Haematologica 85(11 Suppl), 81-85; Nov. 2000

MYASTHENIA
Rabusin M et al.; ``Immunoablation followed by autologous hematopoietic 
            stem cell infusion for the treatment of severe autoimmune 
            disease''; Haematologica 85(11 Suppl), 81-85; Nov. 2000

RED CELL APLASIA
Rabusin M et al.; ``Immunoablation followed by autologous hematopoietic 
            stem cell infusion for the treatment of severe autoimmune 
            disease''; Haematologica 85(11 Suppl), 81-85; Nov. 2000

AUTOIMMUNE CYTOPENIA
Rabusin M et al.; ``Immunoablation followed by autologous hematopoietic 
            stem cell infusion for the treatment of severe autoimmune 
            disease''; Haematologica 85(11 Suppl), 81-85; Nov. 2000
Papadaki HA et al.; ``Assessment of bone marrow stem cell reserve and 
            function and stromal cell function in patients with 
            autoimmune cytopenias''; Blood 96, 3272-3275; Nov 1 2000
                           IMMUNODEFICIENCIES
Banked unrelated umbilical cord blood was used to reconstitute the 
            immune system in 2 brothers with X-linked 
            lymphoproliferative syndrome and 1 boy with X-linked 
            hyperimmunoglobulin-M syndrome. Two years after 
            transplantation, all 3 patients have normal immune systems. 
            These reports support the wider use of banked partially 
            matched cord blood for transplantation in primary 
            immunodeficiencies.

Reference:
Ziegner UH et al.; ``Unrelated umbilical cord stem cell transplantation 
            for X-linked immunodeficiencies''; J Pediatr 138(4), 570-
            573; April 2001
Eight children with severe immunodeficiencies treated by adult bone 
            marrow stem cell transplants. Six of 8 showed relatively 
            normal immune systems after 1 year.

Reference
Amrolia, P. et al., ``Nonmyeloablative stem cell transplantation for 
            congenital immunodeficiencies'', Blood 96, 1239-1246, Aug. 
            15, 2000.

SEVERE COMBINED IMMUNODEFICIENCY SYNDROME-X1 (ASC gene therapy)
Cavazzana-Calvo M et al.; ``Gene therapy of human severe combined 
            immunodeficiency (SCID)-X1 disease''; Science 288, 669-672; 
            April 28, 2000
                                ANEMIAS
SICKLE CELL ANEMIA
Gore L. et al.; ``Successful cord blood transplantation for sickle cell 
            anemia from a sibling who is human leukocyte antigen-
            identical: implications for comprehensive care'', J Pediatr 
            Hematol Oncol 22(5):437-440; Sep-Oct 2000
Steen RG et al.; ``Improved cerebrovascular patency following therapy 
            in patients with sickle cell disease: initial results in 4 
            patients who received HLA-identical hematopoietic stem cell 
            allografts''; Ann Neurol 49(2), 222-229; Feb. 2001
Wethers DL; ``Sickle cell disease in childhood: Part II. Diagnosis and 
            treatment of major complications and recent advances in 
            treatment''; Am. Fam. Physician 62, 1309-1314; Sept. 15, 
            2000

SIDEROBLASTIC ANEMIA
Ayas M et al.; ``Congenital sideroblastic anaemia successfully treated 
            using allogeneic stem cell transplantation''; Br J Haematol 
            113, 938-939; June 2001
Gonzalez MI et al.; ``Allogeneic peripheral stem cell transplantation 
            in a case of hereditary sideroblastic anaemia''; British 
            Journal of Haematology 109, 658-660; 2000

WALDENSTROM'S MACROGLOBULINEMIA
Anagnostopoulos A et al.; ``High-dose chemotherapy followed by stem 
            cell transplantation in patients with resistant 
            Waldenstrom's macroglobulinemia''; Bone Marrow Transplant 
            27, 1027-1029; May 2001

APLASTIC ANEMIA
Gurman G et al.; ``Allogeneic peripheral blood stem cell 
            transplantation for severe aplastic anemia''; Ther Apher 
            5(1), 54-57; Feb. 2001
Kook H et al.; ``Rubella-associated aplastic anemia treated by 
            syngeneic stem cell transplantations''; Am. J. Hematol. 64, 
            303-305; August 2000

AMEGAKARYOCYTIC THROMBOCYTOPENIA
Yesilipek et al.; ``Peripheral stem cell transplantation in a child 
            with amegakaryocytic thrombocytopenia''; Bone Marrow 
            Transplant 26, 571-572; Sept. 2000

CHRONIC EPSTEIN-BARR INFECTION
Fujii N et al.; ``Allogeneic peripheral blood stem cell transplantation 
            for the treatment of chronic active epstein-barr virus 
            infection''; Bone Marrow Transplant 26, 805-808; Oct. 2000
Okamura T et al.; ``Blood stem cell transplantation for chronic active 
            Epstein-Barr virus with lymphoproliferation''; Lancet 356, 
            223-224; July 2000

FANCONI'S ANEMIA
Kohli-Kumar M et al., ``Haemopoietic stem/progenitor cell transplant in 
            Fanconi anaemia using HLA-matched sibling umbilical cord 
            blood cells'', British Journal of Haematology 85, 419-422, 
            October 1993

DIAMOND BLACKFAN ANEMIA
Ostronoff M et al., ``Successful nonmyeloablative bone marrow 
            transplantation in a corticosteroid-resistant infant with 
            Diamond-Blackfan anemia'', Bone Marrow Transplant. 34, 371-
            372, August 2004

THALASSEMIA
Tan PH et al., ``Unrelated peripheral blood and cord blood 
            hematopoietic stem cell transplants for thalassemia 
            major'', Am J Hematol 75, 209-212, April 2004
                                 STROKE
Meltzer CC et al.; ``Serial [18F]Fluorodeoxyglucose Positron Emission 
            Tomography after Human Neuronal Implantation for Stroke''; 
            Neurosurgery 49, 586-592; 2001.
Kondziolka D et al.; ``Transplantation of cultured human neuronal cells 
            for patients with stroke''; Neurology 55, 565-569; August 
            2000
Cartilage and Bone Diseases
OSTEOGENESIS IMPERFECTA
Horwitz EM et al., ``Isolated allogeneic bone marrow-derived 
            mesenchymal cells engraft and stimulate growth in children 
            with osteogenesis imperfecta: Implications for cell therapy 
            of bone'', Proceedings of the National Academy of Sciences 
            USA 99, 8932-8937; 25 June 2002.
Horwitz EM et al., ``Clinical responses to bone marrow transplantation 
            in children with severe osteogenesis imperfecta'', Blood 
            97, 1227-1231; 1 March 2001.
Horwitz, EM et al.; ``Transplantability and therapeutic effects of bone 
            marrow-derived mesenchymal cells in children with 
            osteogenesis imperfecta''; Nat. Med. 5, 309-313; March 
            1999.

SANDHOFF DISEASE
                          CORNEAL REGENERATION
Anderson DF et al.; ``Amniotic Membrane Transplantation After the 
            Primary Surgical Management of Band Keratopathy''; Cornea 
            20(4), 354-361; May 2001
Anderson DF et al.; ``Amniotic membrane transplantation for partial 
            limbal stem cell deficiency''; Br J Ophthalmol 85(5), 567-
            575; May 2001
Henderson TR et al.; ``The long term outcome of limbal allografts: the 
            search for surviving cells''; Br J Ophthalmol 85(5), 604-
            609; May 2001
Daya SM, Ilari FA; ``Living related conjuctival limbal allograft for 
            the treatment of stem cell deficiency''; Opthalmology 180, 
            126-133; January 2001
Schwab IR et al.; ``Successful transplantation of bioengineered tissue 
            replacements in patients with ocular surface disease''; 
            Cornea 19, 421-426; July 2000.
Tsai et al.; ``Reconstruction of damaged corneas by transplantation of 
            autologous limbal epithelial cells.''; New England Journal 
            of Medicine 343, 86-93, 2000.
Tsubota K et al.; ``Treatment of severe ocular-surface disorders with 
            corneal epithelial stem cell transplantation''; New England 
            Journal of Medicine 340, 1697-1703; June 3, 1999
Ocular corneal regeneration

HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS
Matthes-Martin S et al.; ``Successful stem cell transplantation 
            following orthotopic liver transplantation from the same 
            haploidentical family donor in a girl with hemophagocytic 
            lymphohistiocytosis''; Blood 96, 3997-3999; Dec 1, 2000

PRIMARY AMYLOIDOSIS
Sezer O et al.; ``Novel approaches to the treatment of primary 
            amyloidosis''; Exper Opin. Investig. Drugs 9, 2343-2350; 
            Oct 2000
LIMB GANGRENE
Tateishi-Yuyama E et al.; ``Therapeutic angiogenesis for patients with 
            limb ischaemia by autologous transplantation of bone-marrow 
            cells: a pilot study and a randomised controlled trial''; 
            Lancet 360, 427-435; 10 August 2002.
SURFACE WOUND HEALING
Badiavas EV, ``Participation of Bone Marrow Derived Cells in Cutaneous 
            Wound Healing'', Journal Of Cellular Physiology 196, 245-
            250; 2003.
                              HEART DAMAGE
Wollert KC et al., ``Intracoronary autologous bone-marrow cell transfer 
            after myocardial infarction: the BOOST randomised 
            controlled clinical trial'', Lancet 364, 141-148, 10 July 
            2004
Britten MB et al., ``Infarct remodeling after intracoronary progenitor 
            cell treatment in patients with acute myocardial 
            infarction''; Circulation 108, 2212-2218; Nov 2003
Perin EC et al.; ``Transendocardial, autologous bone marrow cell 
            transplantation for severe, chronic ischemic heart 
            failure''; Circulation 107, r75-r83; published online May 
            2003
Stamm C et al.; ``Autologous bone-marrow stem cell transplantation for 
            myocardial regeneration''; The Lancet 361, 45-46; 4 January 
            2003
Tse H-F et al.; ``Angiogenesis in ischaemic myocardium by 
            intramyocardial autologous bone marrow mononuclear cell 
            implantation''; The Lancet 361, 47-49; 4 January 2003
Strauer BE et al.; ``Repair of infarcted myocardium by autologous 
            intracoronary mononuclear bone marrow cell transplantation 
            in humans''; Circulation 106, 1913-1918; 8 October 2002
Strauer BE et al.; ``Myocardial regeneration after intracoronary 
            transplantation of human autologous stem cells following 
            acute myocardial infarction''; Dtsch Med Wochenschr 126, 
            932-938; Aug 24, 2001
Menasche P et al. ``Myoblast transplantation for heart failure.'' 
            Lancet 357, 279-280; Jan 27, 2001
Menasche P et al. [``Autologous skeletal myoblast transplantation for 
            cardiac insufficiency. First clinical case.''] [article in 
            French] Arch Mal Coeur Vaiss 94(3), 180-182; March 2001
PARKINSON'S DISEASE
Levesque M and Neuman T, ``Autologous transplantation of adult human 
            neural stem cells and differentiated dopaminergic neurons 
            for Parkinson disease: 1-year postoperative clinical and 
            functional metabolic result'', American Association of 
            Neurological Surgeons annual meeting, Abstract #702; 8 
            April 2002
Gill SS et al.; ``Direct brain infusion of glial cell line-derived 
            neurotrophic factor in Parkinson disease''; Nature Medicine 
            9, 589-595; May 2003 (published online 31 March 2003)
See also July 14, 2004 Senate testimony by Dr. Michel Levesque:
      http://commerce.senate.gov/hearings/
            testimony.cfm?id=1268&wit_id=3670
and Mr. Dennis Turner:
      http://commerce.senate.gov/hearings/
            testimony.cfm?id=1268&wit_id=3676
SPINAL CORD INJURY
See July 14, 2004 Senate testimony by Dr. Jean Peduzzi-Nelson:
      http://commerce.senate.gov/hearings/
            testimony.cfm?id=1268&wit_id=3671
and a more extensive testimony at:
      http://www.stemcellresearch.org/testimony/peduzzi-nelson.htm
and Ms. Laura Dominguez:
      http://commerce.senate.gov/hearings/
            testimony.cfm?id=1268&wit_id=3673
and Ms. Susan Fajt:
      http://commerce.senate.gov/hearings/
            testimony.cfm?id=1268&wit_id=3674
For appended review paper on adult stem cells, see
      http://bioethics.georgetown.edu/pcbe/reports/stemcell/
            appendix_.html

    Senator Brownback. Thank you, Dr. Prentice.
    Dr. Hedrick, thank you for joining us today.

          STATEMENT OF MARC HEDRICK, M.D., PRESIDENT, 
                           MacroPore

    Dr. Hedrick. Mr. Chairman, Mr. Wyden, thank you for 
allowing me to be here today.
    I've been fortunate to be have been involved on the front 
lines of the stem cell debate for some time. As a surgeon at 
UCLA, I saw, firsthand, the need for stem cell treatments in my 
patients. As a researcher, I received NIH funding while doing 
stem cell research at UCLA in our laboratory. And now I serve 
as President of MacroPore Biosurgery, a San Diego-based 
biotechnology company that's dedicated to developing adult stem 
cell therapies to help as many patients as we can.
    Based on this experience, I feel like I can say to you, in 
the strongest possible terms, we truly are on the edge of a new 
frontier in medicine. Over the past 2 years, our company has 
made a strategic decision to try to take a leadership role in 
developing adult stem cell therapies. This decision was based 
both on our excitement for the technology, but also our vision 
for what we think it can do for patients.
    If I may, permit me to quote from the NIH, ``Given the 
enormous promise of stem cells to develop new therapies for the 
most devastating diseases when a readily available source of 
stem cells is identified, it is not too unrealistic to say that 
this research will revolutionize the practice of medicine and 
improve the quality and the length of life.'' And that's 
absolutely our goal. We agree with the NIH that cell 
availability has been a significant challenge, not only for the 
clinical, but for the commercial application of stem cells.
    Stem cells have been thought to be rare, difficult to 
obtain, and requiring long periods of cell culture or 
multiplication. But today we have found a potential solution to 
some of the significant challenges particularly related to cell 
availability. We believe the solution is the use of fat or 
adipose tissue as the source of stem cells. It's a low-cost, 
high volume alternative to other stem cell sources. This 
technology enables us to rethink how patients might be treated 
using their own stem cells. It's an important breakthrough in 
stem cell technology.
    From adipose, we can obtain at least two of the key types 
of adult stem cells that could potentially treat many diseases. 
Heart disease, stroke, injured bones and joints, vascular 
disease, degenerative spinal disease are all diseases that are 
in our target area.
    The first adult stem cells, though, were identified 40 
years ago. Since then, bone-marrow transplants have been very 
common for treating things like blood diseases and for cancers.
    And only until recently, bone marrow was thought to be the 
only significant clinical reservoir of stem cells in the adult. 
But even this source yields a relatively few number of stem 
cells.
    So how does adipose or fat tissue measure up as a stem cell 
source? Well, about a cup of adipose tissue translates into 
about a million stem cells. That's about a hundred times more 
stem cells found in the same amount of bone marrow.
    And let me use myself as an example to, sort of, illustrate 
this.
    Senator Brownback. A cup has a hundred million--did you say 
a hundred million stem cells, a cup of fat?
    Dr. Hedrick. About a million stem cells.
    Senator Brownback. A million. Wow. No wonder it grows so 
easy. I'm sorry, go ahead.
    [Laughter.]
    Dr. Hedrick. We haven't solved that problem yet.
    Senator Brownback. Yes.
    [Laughter.]
    Dr. Hedrick. But I'm six feet one inch tall, weigh about 
180 pounds, and about 15 percent of my body weight is fat 
tissue. That translates to about 27 pounds of fat, which equals 
about six billion stem cells.
    What does this mean? I think it means opportunities, many 
opportunities, potentially, to use your own body to heal 
different problems and diseases that you have, but not stem 
cells have been obtained in weeks or months, but stem cells 
that can be obtained in about an hour.
    And so what we're talking about with adipose-derived stem 
cells is using stem cells in real time without cell culture. 
This realtime approach is not just conceptual. At this 
meeting--this week at a cardiology meeting in Washington, D.C., 
our company, along with our collaborators at UCLA and Cedar 
Sinai, reported the use of adipose-derived stem cells, and 
noted that they are safe and improved heart function after 
heart attacks. We used pigs in this study, because they're 
predictive of future success in the treatment of heart attacks.
    Heart disease is fast becoming the most promising area for 
the use of stem cell therapy. In 15 years, cardiovascular 
disease is going to be the principal cause of death worldwide, 
not just in the U.S. Over a million Americans each year have a 
heart attack, and another six million Americans right now have 
heart failure. Sadly, this means that one out of three people 
in this room are going to die from heart disease. It's a 
staggering thought.
    And MacroPore is addressing this clinical need by 
developing a unique system that enables doctors to take the 
patient's stem cells and then treat them in real time. If 
successful, the system will fundamentally be state-of-the-art 
for heart attack treatment. It will enable us to move from 
supportive care, which is really all we have to offer patients 
now, to regenerative therapy.
    Both our research and the research of our collaborators and 
others have found out that adult stem cells can do three 
important things for the failing heart. It can make new heart 
cells, it can make new blood vessels, and it can rescue dying 
heart muscle. While the science is obviously complex and 
there's still a lot to learn, for the doctor and the patient 
the procedure represents a relatively simple way to help heal 
the heart.
    Seven clinical studies, most of them clinician-initiated 
studies, are now in progress around the world to study adult 
stem cells for cardiovascular disease, and the early results 
are promising. For example, follow up data just presented from 
the Joint Texas Heart Institute and Brazilian Heart Failure 
Stem Cell Human Trial noted that four out of five patients 
being studied were no longer in need of a heart transplant. 
Those patients were treated with adult bone-marrow stem cells.
    But despite all the clinical successes of adult stem cells, 
misconceptions are still commonplace. For example, in a recent 
study of Americans who claim to be knowledgeable about adult 
stem cells, 68 percent thought that adult stem cells come from 
embryos. But there are other misconceptions that perhaps are 
more subtle. Some think that adult stem cells are too rare, 
don't multiply well enough, or are too limited in their potency 
to ever be useful.
    But all of these misconceptions are just that, they're 
misconceptions. The truth is that bone-marrow and adipose 
tissue are clinically promising sources of adult stem cells, 
they grow well in the petri dish, and they have the ability to 
make and repair many types of tissues throughout the body.
    So I think we often make the mistake of referring to ``the 
promise of stem cells,'' like it's some future event. And, in 
fact, this promise has already become a reality. The list of 
successful therapies that are being treated with adult stem 
cells grows every year, as does the list of patients' health.
    While there's still a tremendous amount of work to be 
done--and I don't want to belittle this--I would humbly remind 
you that, in many cases, the promise of adult stem cells is 
already being realized.
    Thank you.
    [The prepared statement of Dr. Hedrick follows:]

     Prepared Statement of Marc Hedrick, M.D., President, MacroPore
    Mr. Chairman, Distinguished Members of Committee, I would like to 
thank you for the opportunity to be here today.
    I have been fortunate to have been on the front lines of the stem 
cell issue. As a surgeon at UCLA, it was easy to recognize the need for 
stem cell treatments in my patients, as a researcher, I received NIH 
funding to study adult stem cells through our program at UCLA and now 
as President of MacroPore, a public company located in San Diego, 
California our group is focused on developing adult stem cell therapies 
for as many people as possible. Based on this diverse experience, I 
feel I can say to you in the strongest possible terms, we truly are on 
the edge of a new frontier in medicine.
    Over the past 2 years, our company, has made a strategic decision 
to take a leadership role in developing adult stem cell therapies. In 
large part this decision is based our excitement and vision for what 
our technology will be able to do for patients whom may benefit from 
stem cell therapies.
    According to an official statement of the NIH in May 2000:

        ``. . . given the enormous promise of stem cells to the 
        development of new therapies for the most devastating diseases, 
        when a readily available source of stem cells is identified, it 
        is not too unrealistic to say that this research will 
        revolutionize the practice of medicine and improve the quality 
        and length of life.''

    That certainly is our goal.
    We recognize that cell availability has been the most significant 
unsolved problem for the clinical application of stem cells. Stem cells 
have been thought to be rare, difficult to obtain, often requiring long 
periods of cell culture.
    Today, we have found a potential solution to the significant 
challenge of cell availability. The solution is the use of fat tissue 
as a source of stem cells. I know we are all familiar with having a 
little too much fat tissue. With this low cost, high volume alternative 
to other stem cell sources, we are able to rethink how patients can be 
treated using their own stem cells. We view this as an important new 
breakthrough in adult stem cell research.
    From this tissue source, we can obtain large numbers of at least 2 
of the key varieties of adult stem cells: mesenchymal stem cells and 
endothelial progenitor cells. The resulting implication is that fat 
tissue is a plentiful source of stem cells that potentially can treat 
many diseases such as heart disease, stroke, injured bones and joints, 
degenerative spinal disease and vascular diseases, to name a few of the 
disorders researchers are currently studying.
    As you know, stem cells are unique cells that have 2 well 
established properties: they have the ability to make more stem cells 
through cell multiplication, and they can mature into differentiated 
cells or tissues. The first adult stem cells were identified 
approximately 40 years ago and have been extensively studied and used 
to treat many diseases, particularly blood diseases or cancer, through 
bone marrow transplants. Later, in the 1990s, adult stem cells were 
then identified broadly in many organs and tissues, but in small 
numbers. They had to be multiplied in Petri dishes to collect large 
enough batches of cells to be useful, which could take many weeks.
    Until today, bone marrow was thought to be the only significant 
clinical reservoir of adult stem cells. But it too yields only a 
limited number of cells.
    Believe it or not, a few ounces of fat, or less than a cup, can 
yield approximately 1 million stem cells. This is about 100x more stem 
cells found in the same amount of bone marrow.
    There is no shortage of fat either. According to scientific 
calculations, Americans carry 30 pounds of fat tissue around with them. 
Conceptually, it is important to understand that dosing stem cells for 
patients will be like giving aspirin to patients with headaches.
    If you do not give them aspirin, their headache will not get 
better.
    It is the same with stem cells, if they don't get enough stem 
cells, they won't get better.
    In fact, this week at a meeting of cardiologists here in 
Washington, our Company in conjunction with UCLA and Cedar& Sinai 
Medical Center reported that fat derived stem cells are safe and 
improve heart function after heart attacks in pigs-which is animal 
model that is most predictive of future success in the treatment of 
human heart attacks.
    And here's what that really means for all of us. Heart attack 
patients can be treated with their own stem cells soon after they 
arrive in the emergency room. Time is critical in the treatment of 
heart attack. The longer the delay in treatment, the more complex and 
difficult the stem cell treatment becomes.
    However, with fat as a stem cell source, we can retrieve a 
therapeutic dose of cells, all in about an hour, not the weeks that 
cell culturing can take. We can treat patients in ``real time''.
    Heart disease is becoming the most promising emerging area for the 
use of stem cell therapy. The timing is fortunate, because in 15 years, 
cardiovascular disease will supplant infectious disease as the 
principle cause of death worldwide. Sadly, one in 3 of us in this room 
will die of cardiovascular disease. A rather staggering thought. Over 1 
million Americans each year have a heart attack and another 6 million 
have significant heart failure. Compounding the need is the fact that 
the efficacy of heart failure drugs seems to be at a plateau. Despite 
the prevalence, only 8 percent of drug discovery investment is going to 
cardiovascular disease.
    The stem cell system that MacroPore is developing for treating 
heart patients is unique in its ability to treat the patient with their 
own stem cells immediately without waiting for someone else's cells to 
grow in a Petri dish.
    Here's what it means in a real life situation.
    If someone was unfortunate enough to have a heart attack today, 
that person would develop severe pain below the breast bone and be 
brought immediately by ambulance to the hospital. If the examination 
and lab tests confirm the heart attack, the cardiologist will 
immediately move the patient into a cardiac catheterization suite, 
where through a small catheter, dye will be injected into the heart so 
areas of blood vessel blockage can be seen and treated with a balloon 
or stent. This is called the angiogram procedure. Except for the 
addition of some standard heart medications, this is essentially the 
state-of-the-art for heart attack treatment.
    However, with the availability stem cells derived from fat tissue, 
the cardiologist will soon be able to take the patient's own stem cells 
and reinject them directly through the angiogram catheter into the 
heart in about an hour. While the science is complex, for the doctor 
and patient the procedure represents a truly simple way to help heal 
the heart.
    This 'global epidemic' of cardiovascular disease corresponds to a 
significant opportunity for stem cell therapies. Many groups worldwide 
are leveraging the safety and efficacy profile of adult stem cells for 
this epidemic.
    Seven clinical studies, mostly clinician initiated, are now in 
progress globally to study adult stem cells in cardiovascular disease, 
and an estimated 150+ patients have been treated thus far. Phase II 
efficacy trials are underway and early results are promising. If the 
improvements in cardiac function now being seen hold true, previous 
data suggests this may result in lower hospital utilization rates, 
decreased hospital readmission rates and possibly removal of patients 
from the transplant list. Therefore, while most importantly having the 
potential to prolong life, adult stem cells may soon save some of the 
$18B spent each year on heart failure.
    In fact, last week, in follow up data to the Texas Heart Institute/
Pro-Cardiac Hospital stem cell trial, Dr. Hans Fernando Dohmann, 
coordinator of the research noted four out of five patients being 
studied no longer needed transplants after being treated with stem 
cells. He said, ``It was the first time we saw that stem cells actually 
generate new arterioles'' he went on to say that, ``[stem cells] 
eliminated the need for transplants in four patients who had had 
indisputable transplant indications.''
    The success we are seeing in the treatment of cardiovascular 
disease should come as no surprise. Adult stem cells treatments have 
been commonplace in medicine for decades. Furthermore, it is the daily 
job of adult stem cells to sustain, renew, heal and in some 
circumstances regenerate human organs and tissues over one's entire 
life.
    For decades, doctors have, sometimes intuitively, taken adult stem 
cells from one part of the body and transplanted them to another area 
to help patients. We have given these operations names like skin 
grafting, bone marrow transplantation, and bone grafting, but make no 
mistake-these operations achieve durable results in part by virtue of 
transplanting adult stem cell populations.
    But despite the daily clinical successes of adult stem cells, 
misconceptions are commonplace. For example, in a recent study of 
Americans who claim to be knowledgeable about stem cells, 68 percent 
claim adult stem cells are from embryos. More subtle misconceptions 
include the idea that stem cells are too rare, don't multiply well or 
are too limited in their potency to be useful. All of these 
misconceptions are just that, they are not factually correct. The truth 
is that both bone marrow and fat tissue are plentiful and clinically 
promising sources of adult stem cells. They both multiply well, and 
increasingly more and more research shows that adult stem cells have 
the ability to make many cell and tissue types throughout the body.
    We often make the mistake of referring to the promise of stem cells 
as if it is a future event. In fact, this 'promise' has become a 
reality. The list of successful therapies using adult stem cell grows 
yearly as does the list of patients cured. While there is still much 
work to be done, I would humbly remind you that in many cases the 
'promise' has already been realized.

    Senator Brownback. Thank you.
    Let me--I want to probe in this some more. So you're saying 
use the fat tissue stem cells in a broad array of places in the 
body. And I take it what you're suggesting is that this is 
going to be the new source of bone marrow; I mean, that what 
we've been doing in bone marrow, you can do with fat tissue 
stem cells. Is that correct? Kind of in layman's terms, is 
that----
    Dr. Hedrick. It is possible that, with further research, we 
could show that fat tissue is equal to bone marrow as a source 
of adult stem cells. But bone marrow's been around for about 40 
years, and there's a lot of very good research for that. And 
we've only been around for about 5 years, and we're, sort of, 
catching up. So I think the jury is still out on just how 
significant adipose is as a source of stem cells.
    Senator Brownback. Now, the heart trials you were talking 
about, the seven or eight clinical trials going on around the 
world, where damaged heart tissue, dead heart tissue, is being 
regenerated with stem cells, that's all being done through bone 
marrow stem cells. Is that correct?
    Dr. Hedrick. Yes, sir. All that study's being--all the 
studies are being done with either bone marrow stem cells or 
stem cells that have been tricked out of the bone marrow by 
giving the patient a drug and then removing the blood from the 
patient several days later.
    Senator Brownback. But it's showing great promise, great 
success, a number of these people are getting off the 
transplant lists, their heart is--what, the fracture rate? What 
do they call that, the pumping rate of the----
    Dr. Hedrick. Ejection fraction.
    Senator Brownback. I'm not a scientist, but I've listened 
to enough of this that I'm getting closer. That that's really 
growing, doing well.
    You were saying that you have an animal trial, though, that 
shows that you can do this with fat stem cells. Is that 
correct?
    Dr. Hedrick. Yes, sir. There actually have been one 
reported, and now our trial, that show that stem cells from 
adipose tissue make the heart function better. You talk about 
pumping ability; that's called ejection fraction. And the early 
results--again, these are in pigs, not in humans, and we have 
to make sure they translate--that we're seeing somewhere in the 
neighborhood of a 20 to 30 percent improvement in the pumping 
ability of the heart.
    Senator Brownback. What about the--one of the beefs on 
adult stem cells for some period of time has been the 
plasticity. And, Dr. Daley, you may want to jump on this. But 
it's saying these just aren't----
    Dr. Daley. Yes.
    Senator Brownback.--we don't think you can do this. But, 
Dr. Hedrick--let me get him first, and then I'll bounce over to 
you, happily--you're saying that with the fat tissue, you 
believe the plasticity is there for these to be able to treat a 
whole host of different types of needs within the body.
    Dr. Hedrick. Well, I----
    Senator Brownback. What do you base that upon?
    Dr. Hedrick. I can only speak to the science. And we, our 
group, and many others around the world have published the fact 
that there are nine or ten different kinds of cell types that 
can come from adipose tissue or fat tissue.
    Senator Brownback. Nine of ten.
    Dr. Hedrick. Nine or ten different types of cells.
    Senator Brownback. OK.
    Dr. Hedrick. Effectively everything we've looked for in a 
meaningful way, we've been able to show.
    The research in heart, though, is interesting. And this is 
really a new area, not only for us, but others. And we really 
haven't shown that--in humans or in animals--that we can get 
heart differentiation, but we've shown it in the petri dish, 
and we've shown it in rodents, and other people have shown the 
same thing.
    Senator Brownback. So that you believe that the plasticity 
is not an issue on this type of stem cell, the fat tissue stem 
cells. Is that correct?
    Dr. Hedrick. Well, I believe that of the things that we've 
done so far, there's a high likelihood that these cells could 
be clinically useful. But I can't speak to the other 180 
different tissue types, the cell types in the body. But what 
I'm saying is, these cells are on par, in terms of their 
plasticity, seemingly, with bone marrow.
    Senator Brownback. Dr. Daley?
    Dr. Daley. Yes, I--the science behind cardiovascular 
regeneration is a perfect case in point where the claims are 
getting way ahead of the actual scientific reality. It's a very 
seductive possibility that bone-marrow cells or fat cells 
injected into the heart is going to regenerate the failing 
heart muscle.
    In fact, where it has been looked at very carefully, no 
heart-muscle cells are actually regenerated at all. The data 
that suggests there's an effect on the function of the heart is 
fairly reliable and reproducible in many centers around the 
world. But it's becoming, I think, increasingly clear--and in 
data that was presented at this same that Dr. Hedrick referred 
to--it may not be the cells themselves, but rather factors that 
are liberated from the cells--cytoprotective or cytokine or 
growth factors--that actually save the dying heart muscle in 
the various animal models. Whether or not this will translate 
into effective human therapies, I think, is really still an 
open question.
    So it may be that the stem cells aren't there as--for 
plasticity at all; but, rather, to produce these other 
proteins, and I----
    Senator Brownback. But, for whatever reason----
    Dr. Daley.--think that where we're going to move is 
identifying those factors and to deliver them with other means 
not involving stem cells.
    Senator Brownback. But, for whatever reason, it's working. 
You believe, in these trials, it appears to be something that's 
happening positive in the pump rates of these people is 
working.
    Dr. Daley. Something is happening. But whether or not it's 
a fat stem cell or a bone-marrow stem cell becoming a heart 
muscle, I think is highly unlikely.
    Senator Brownback. But the heart is improving. They're 
taking them off----
    Dr. Daley. That's right.
    Senator Brownback.--transplant----
    Dr. Daley. So the way the science should go is to be very 
careful about how you design the experiments, to determine 
whether it's the cells or the things the cells are making which 
are actually having the beneficial effect on the heart.
    Senator Brownback. I understand. I also understand, if I'm 
a heart patient, what I care about is that this is working. And 
I understand you, from the scientist--your point of view.
    The tumor issue, Dr. Daley, I want to address that, because 
that has come up previously in other work, other policy issues 
that have come up. In 1993--and you maybe familiar with this--
we started down the road of funding fetal tissue use--aborted 
fetuses, use the fetal tissue. A lot of the claims being made 
then are being made now in embryonic stem cell. And I think 
that's--so that's always part of the cynicism and the debate.
    And I've got a series of quotes from people in 1993 that 
this is going to cure Parkinson's and Alzheimer's and all sorts 
of things with fetal tissue research--or fetal tissue transfer. 
And the issue then--and it seemed as if what happened at that 
point in time--they did a series of clinical trials, series of 
applications, and these were just not--they were not stable 
cells. I believe, in the New York Times, they had a series of 
articles on this, that once implanted in the brain, they were 
forming some--forming some brain tissue, but some were forming 
hair, some were forming--were developing fingernails, some were 
developing tumors.
    This--here's a question that I've wrestled with, is, that's 
a further-down-the-line development than what you're working on 
right now. You're at the embryonic--so you're even earlier--
you're at an earlier growth stage. You're at a--it seems to me, 
as a layman, a less stable stage of this cell's development. 
It'll rapidly grow, but it'll make everything, and that's the 
real problem. It didn't work there, and what makes you think it 
will not form tumors now, when you've backed up to even an 
earlier stage?
    Dr. Daley. Well, we would all have to be very careful and 
look for that very risk. There's no doubt that undifferentiated 
embryonic stem cells, when put into an animal, will form a form 
of benign encapsulated tumor, called the teratoma. And I think 
everybody who is involved in embryonic stem cell 
transplantation strategies is going to be prepared to look for 
that and hope it doesn't happen.
    Now, the goal in ES research is to pre-differentiate the 
cells to a stage where they could be, then, characterized and 
isolated and purified free of these tumor-forming cells.
    I should point out that this issue of genomic and 
epigenetic instability that Dr. Prentice referred to, and that 
is often referred to in the ES cells, is a characteristic of 
all cells that are kept for long periods in culture. In fact, I 
think it's rather remarkable that embryonic stem cells are as 
stable as they are in their immortal state, because, for most 
cells, getting things to grow in a petri dish actually involves 
significant chromosomal or genetic changes.
    So we're all aware of this issue. We do not think it's 
going to be a deal-breaker for bringing these types of cells 
into clinical therapies.
    Senator Brownback. Senator Wyden?
    Senator Wyden. Thank you, Mr. Chairman.
    Dr. Prentice, several hours ago, when we began, I noted 
that there was an important article in the Washington Post a 
couple of days ago----
    Dr. Prentice. Yes, sir.
    Senator Wyden.--outlining these new studies that show that 
human embryonic stem cells are showing great promise in some 
key areas, particularly vision. I want to be clear, are you 
saying that the published peer-reviewed results, like those 
that are cited in the article that I have mentioned with 
respect to embryonic stem cells, are you saying that these 
articles are off-base, that they're invalid?
    Dr. Prentice. I'm not saying they're off-base, Senator. 
What I'm saying is, if you look at the articles carefully, in 
terms of how much success have they achieved, especially if our 
goal is regenerating tissue for disease damage, if you read, 
for example, the article about the vision regeneration, what 
Dr. Lanza and his team at Advanced Cell Technology did was 
achieve--for the first time, I might note--differentiation of 
the specific cell type from human embryonic stem cells. He 
calls it an RPE, retinal pigmented epithelial cell. Now, this 
was all done in the dish. He actually got some of them to 
coalesce together. I think he notes, perhaps, in the article, 
they looked like little eyes coalescing together. Probably not. 
But it's interesting that they showed that characteristic. He 
did not, at least in terms of the peer-reviewed report, test 
the ability of these cells to treat any kind of retinal 
degeneration.
    I'd note that Mr. Weiss failed to report, in the Post, a 
paper that came out just 2 weeks ago in which a group at UCLA 
School of Medicine reported that they had actually rescued or 
repaired retinal degeneration by injecting adult bone marrow 
stem cells into the eyes of mice suffering from a similar type 
of condition as Dr. Lanza has proposed to treat. There actually 
have been two other previous adult stem cell studies where they 
were doing the same thing for models of macular degeneration. 
As we age, our retinas tend to break down, retinitis 
pigmentosa, which is another similar condition.
    So what I'm saying, Senator, is----
    Senator Wyden. You're saying that there's no problem with 
the validity of this study. I just want to move on. You----
    Dr. Prentice. No, the----
    Senator Wyden.--you'd like----
    Dr. Prentice. No, the scientific evidence----
    Senator Wyden.--you'd like some----
    Dr. Prentice.--is there.
    Senator Wyden.--you'd like some other----
    Dr. Prentice. It's just about 3 years behind.
    Senator Wyden.--and you'd like some other studies to be 
made a part of the record, as well. Is that----
    Dr. Prentice. I would hope that Dr. Lanza would now show us 
that those cells could achieve the same type of success in 
animals, safely, as the adult stem cells.
    Senator Wyden. Another question for you, Dr. Prentice. Are 
you opposed to in vitro fertilization at fertility clinics in 
America? Dr.----
    Dr. Prentice. I've been troubled by it, Senator----
    Senator Wyden. I'd like a yes----
    Dr. Prentice.--because of the manipulation----
    Senator Wyden.--I'd like a yes or no answer, because I was 
really pretty floored by the answer I got, you know, earlier, 
because I had not, you know, heard that from Dr. Doerflinger. I 
had thought that he would not be opposed, that there would be 
some questions with respect to what would be done with the 
embryos. And that's something that I'm interested in. But just 
a yes or no answer. I mean, this is important, because millions 
of couples have found happiness through a specific procedure, 
IVF. Millions of couples. And I like to think that I played an 
itty-bitty part in it because I wrote the one law that makes it 
possible for couples to have some real protections, in terms of 
how they use it. Do you, or do you not, favor IVF as a 
procedure?
    Dr. Prentice. As you've expressed it, yes, I favor IVF. But 
I would like, Senator, to see you write some more laws so that 
they're not making so many embryos that end up in the freezer. 
In Germany, there are 40, total.
    Senator Wyden. Well, the Chairman and I have talked about, 
Dr. Kass and others, have talked talk about ways in which we 
might update the law, but I appreciate your answer and 
appreciate your candor.
    Dr. Daley, a couple of questions for you, if I could. There 
are a wide range of funds, including Federal funding for adult 
stem cell research. And it's been the view of Dr. Prentice and 
others having, you know, reservations about the value of 
embryonic stem cell research. Now, embryonic stem cell 
research, of course, faces restrictions on Federal funding, as 
opposed to adult stem cell research. Do you think, therefore, 
that it is fair to compare the two--adult stem cell research 
and embryonic stem cell research, in terms of the progress, 
given the fact that there are restrictions with respect to 
embryonic stem cell research that there aren't with adult stem 
cells?
    Dr. Daley. Even without regard to the restriction, I think 
it's unfair to say that adult stem cells are doing so much 
better than embryonic stem cells that it justifies putting more 
emphasis behind adult stem cells.
    Really, adult stem cells--and we're talking primarily about 
bone-marrow stem cells--have been studied, really, more like 50 
or 60 years; whereas, human embryonic stem cells were first 
published 6 years ago. You're talking about a tenfold 
difference in time. You know, I mean, I think if you gave me a 
50 year head-start in a bicycle race, I'd probably beat Lance 
Armstrong, too.
    The fact is that human ES cell research is a fledgling 
field just getting off the ground. It has enormous promise, not 
solely for its therapeutic potential, the ability to actually 
move cells into patients, but these are enormously valuable 
tools for research. So you have to give us time to let the 
field mature.
    Senator Wyden. One other question for you, Dr. Daley, with 
respect to the practice of scientists. And I think you heard me 
earlier express--you know, my concern is that I think we're 
just, sort of, headed for a kind of crazy quilt of standards 
with respect to ethical practices, at a minimum. And I think it 
stems from the restrictions on Federal funding. And Dr. 
Doerflinger and others have different views on that, and I 
respect it.
    My question to you would be, If there were Federal 
guidelines coupled with the availability of Federal funds for 
embryonic stem cell research for the new lines, the new areas 
that are so promising, wouldn't those guidelines essentially 
become an industry-wide standard at this point?
    Dr. Daley. I would hope so. I can't answer the specific 
legal aspects of how the Federal guidelines would ultimately 
compete with a patchwork quilt of guidelines on the level of 
the states. But I think we, as scientists, are very much 
looking to the Federal Government for leadership on this issue. 
It would make it a lot easier.
    The cloud----
    Senator Wyden. Wouldn't it be--on that point, wouldn't it 
be in the interest of scientists and industry and all concerned 
if we tried to get to the point where we're sensitive to these 
ethical, you know, concerns? I want to emphasize, I want to do 
that, but we want to do it I in a clear kind of fashion. And 
wouldn't the kind of straightforward Federal role facilitate 
that kind of sensitivity throughout the field?
    Dr. Daley. There's no doubt that, since the NIH is really 
the lifeblood of funding for most of American science, that 
something done at the Federal level, under the auspices of the 
NIH, would certainly clarify the goals and mission of this 
field.
    Senator Wyden. My time is up. Just on this one point, Mr. 
Chairman.
    See, what I'm concerned about is, almost everybody that I 
talk to in this field, regardless of their, you know, point of 
view, will usually say, ``I want a win-win. I want the research 
done, I want to help people who are suffering, and I want to be 
sensitive to ethics.'' Now, nobody wants to just go out and 
say, ``There are no ethical concerns here,'' because there very 
obviously are.
    My concern is that what's going to happen in this country, 
in terms of the direction we're going, instead of getting the 
win-win, we're going to have a lose-lose, we're not going to 
tap all the opportunities for research. And I think I 
documented what's happening in that regard. We're not using the 
available stem cell lines, even from the earlier plan of the 
President, nor are we using the new lines. And we're going to 
cause a significant amount of confusion with respect to what 
the ethical strictures are that we all want to have.
    So instead of the win-win that, I think, virtually 
everybody, regardless of their point of view on this issue 
wants to have, I think if we don't get a clearly defined 
Federal role and have necessary Federal funding, instead of the 
win-win and the kind of opportunities for our country to 
provide the leadership role that we have the potential to play, 
we're going to have more of what I would characterize as a 
lose-lose. And I think that's regrettable, and I think Dr. 
Daley essentially agrees, and I suspect your two colleagues at 
the table would see that differently.
    But, Mr. Chairman, I'm going to have to take off. But I 
think it's been a good hearing, and I thank you again for your 
fairness, in terms of how you approach all of this.
    Senator Brownback. Well, thank you for participating in it.
    I do want to note, though, where you would see a lose-lose 
in this situation, we have patients who are being treated now 
with stem cell therapies, that are being cured. I've had them 
in here testifying--sickle cell anemia, something you'd be 
familiar with, Dr. Daley, umbilical cord blood transfusion, two 
ladies, Susan Fite--and other spinal cord injuries that are 
walking now--using canes, full body feeling, but walking--with 
adult stem cell therapy. We give heart transplant patients--I 
mean, I'd hardly say--call that a lose-lose in this situation. 
I respect how you're looking at it, but this thing is really 
moving forward.
    And, Dr. Daley, as well, in your work, you are receiving 
NIH money to do stem cell research, umbilical--or, I mean, 
excuse me, embryonic and adult. So, I mean, you are receiving 
Federal dollars to do embryonic stem cell research. That's 
happening. And I understand your desire to expand the lines, 
but there is no private limitation at all, there is no 
limitation on any funding, there's no limitation on, for that 
matter, human cloning in this country. So the notion that--you 
know, that we've got this big clamp down at the Federal 
Government, I don't think is accurate. I think you really have 
to look at what is being limited is, you can use the Federal 
dollars on a set of lines that are developed. That's the 
limitation.
    And I would put into the record a Wall Street Journal 
article of August 12, 2004, on the politics--the political 
science, they say, of stem cells. They document FY 2002, $521.1 
million being spent on all forms of stem cell research. I can't 
think there's any country in the world with anywhere close to 
that spending level, and that includes embryonic, human non-
embryonic, nonhuman embryonic, and nonhuman non-embryonic. So 
you've got both adult and embryonic in the whole field, but 
over a half billion dollars on an annual basis.
    [The information referred to follows:]

The Wall Street Journal (on-line edition)--REVIEW & OUTLOOK--August 12, 
                                  2004

                    The (Political) Science of Stems

        You might not know about it from listening to the news lately, 
        [but] the President also looks forward to medical breakthroughs 
        that may arise from stem cell research. Few people know that 
        George W. Bush is the only President to ever authorize Federal 
        funding for embryonic stem cell research.--Laura Bush

    The First Lady was way too polite: The way stem cells have been 
reported, you'd think we were in a new Dark Ages, with government-
backed religious inquisitors threatening scientists on the cusp of 
life-saving treatments.
    Reinforcing this misimpression are the headlines and commentators 
talking up a ``ban'' on research. ``First lady Laura Bush defends ban 
on stem cell research'' is how the Philadelphia Inquirer spun Mrs. 
Bush's talk. A sampling of other headlines shows the Inquirer is far 
from alone: ``Rethink the stem cell ban'' (Des Moines Register); ``Stem 
cell ban stays, despite Reagan pleas'' (Newark Star-Ledger); ``Kerry 
says he'd reverse stem cell ban'' (The Grand Rapids Press); ``Kerry 
`would lift stem cell ban' '' (BBC), and on and on. You get the drift.
    The problem is that the drift is wrong. As Mrs. Bush gently 
reminded her audience in Pennsylvania this week, far from banning 
embryonic stem cell research, George W. Bush is the first President to 
expand Federal funding for it. The nearby table shows that, as a result 
of his decision, Federal funding went from zero in 2000 to nearly $25 
million today--and this doesn't include the many tens of millions more 
being spent by the private sector. As Health and Human Services 
Secretary Tommy Thompson points out, the supply of embryonic stem cell 
shipments available is today greater than the demand.
    In other words, this is not, as Ron Reagan characterized it during 
his prime time slot at the Democratic convention, a battle between 
``reason and ignorance.'' It's an argument about taxpayer money and how 
to draw the lines around it.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    On the whole this would be a healthy debate for America to have. 
But the Kerry campaign seems more interested in politicizing the issue 
by continuing to advance claims for a ban that simply does not exist. 
Typical was the press release by the campaign Website this week 
entitled ``Edwards Calls for an End to Stem Cell Ban and a Return to 
Scientific Excellence in America.'' This is no slip: It's the same 
language Mr. Kerry used in his radio address when he declared he 
intends to ``lift the ban on stem cell research.'' And it's the same 
language Hillary Clinton used during her own convention speech, drawing 
cheers when she invoked the ``need to lift the ban on stem cell 
research.''
    All these people know better. The issue is Federal subsidies. The 
need for a Presidential decision arose from an appropriations rider 
passed by Congress in the mid-1990s forbidding Federal funding for any 
research that creates, injures or destroys human embryos.
    The President's answer was that there ought to be no restrictions 
on the private sector but that Federal subsidies should be limited to 
lines that had already been harvested and should not be used to 
encourage the destruction of embryos. In short, it was a reasonable 
middle ground. It's worth noting that other countries, such as Germany, 
Ireland and Austria, ban even the private sector from creating embryos 
for stem cell research.
    The potential for embryonic stem cells is that they are malleable 
and can differentiate themselves into needed cells. That gives them 
tremendous potential, but it also presents a liability because we can't 
yet control what these cells will turn into. In one animal study, a 
fifth of the mice injected with embryonic stem cells developed brain 
tumors.
    Which helps explain why we still have not had a single human trial 
for embryonic stem cells. And it means that political claims that cures 
for diabetes or Parkinson's are just around the corner are cruelly 
raising false hopes.
    Meanwhile there is another alternative we don't hear much about in 
the headlines: adult stem cells. Unlike embryonic research, adult stem 
cells do not get us into questions about the destruction of human life. 
In addition, a report in the journal Nature this summer suggests that 
adult stem cells may have a broader differentiation potential than 
previously thought.
    Plainly this is one of those subjects that involves clashes of 
goods, in this case the sanctity of human life versus the needs of 
scientific research. The best way to resolve the issue of taxpayer 
funding is to let the American people make that decision themselves, 
through their elected representatives. And dealing, we hope, with the 
science--not just the Kerry campaign sound bites.

    Senator Brownback. So we're investing heavily in this 
field, and finding some beautiful science out. I understand you 
don't have--share quite the ethical concern I do for the----
    Dr. Daley. We always need more resources. There's--there 
are----
    Senator Wyden. Mr. Chairman?
    Dr. Daley.--this is among the most exciting new areas of 
biology. I can tell you that there's an interesting dynamic. On 
the one hand, you have the students who are so enormously 
excited, and they want to jump in; on the other, you have a lot 
of investigators who, because of the current cloud, the 
controversy, are staying on the sidelines. There's a very 
interesting dynamic going on.
    Senator Wyden. Mr. Chairman, can I----
    Senator Brownback. Let me----
    Senator Wyden.--can I just make a unanimous consent 
request, in terms of the battle between newspaper articles?
    [Laughter.]
    Senator Brownback. You can, but I want to finish with my 
battle on this, and then I'll be happy to take that one from 
you.
    There's no country in the world that's investing heavier in 
stem cell research than the United States, is there, Dr. Daley?
    Dr. Daley. Actually, I don't know, but I don't imagine 
there's any country in the world that enjoys the level of 
support that the United States does for basic biomedical 
research, and I am thankful for that, and I think it's one of 
the greatest gifts of our Federal Government to our society.
    Senator Brownback. Well, and we've doubled, under a 
Republican Congress--and Senator Wyden supported it--NIH 
funding over the past 5 years, 6 years. I think most of us view 
that as an excellent investment in research. Stem cell funding 
has benefited from that.
    So I just--I want to get this honed down a little bit. When 
we talk about all these restrictions on it, at the end of the 
day it's bout the level of the lines, and the funding has been 
far and away above what any other country in the world is doing 
in this area.
    So now if you want to put your--I want to ask unanimous 
consent mine be put in the record, and yours will be accepted, 
as well.
    [The articles referred to are reprinted on pp. 3-4 of this 
hearing record.]
    Senator Wyden. I thank you, Mr. Chairman. I just think it's 
important. I would just ask unanimous consent that the two 
articles that have been discussed be placed side by side, 
because the one that my friend, the Chairman, is talking about 
essentially offers an opinion piece, but the--because I have 
read that, and I respect the Wall Street editorial writers on 
this point--but the facts are, as documented in this article 
that I've asked to be put in the record, that only 21 of the 
initial 78 stem cell lines are available to researchers today, 
number one; and scientists say that more than a hundred new 
lines have been developed since the cutoff date of the 
President, and that some of those are better suited for 
research. That is essentially a direct quote out of the article 
that will be in the record in the battle of the newspaper 
articles.
    And just, since the Chairman's being very kind to me, I 
only say that I acknowledge--and, Dr. Prentice, I think you 
might have been here when we talked earlier about adult stem 
cells--there's no question that people have been helped with 
adult stem cells. And more power to it. I am for it. What I am 
concerned about is the potential for the field, and that's what 
I have characterized is, unfortunately, headed toward instead 
of the, kind of, win-win that everybody at this table, you 
know, appropriately and sincerely wants--but in terms of the 
potential, we don't get what we ought to have, in terms of the 
ethical standards, nor do we get what's--in terms of the 
potential for the research.
    But this debate will continue with the usual level of 
thoughtfulness that Senator Brownback brings to this Committee, 
and I look forward to it.
    Senator Brownback. Thank you very much.
    Dr. Daley, in the scientific community, you've got a--
amongst your colleagues when you're meeting, you've got to talk 
about this issue a fair amount. And I'm sure there's a great 
deal of frustration, because I get it in the testimony, people 
coming up and testifying. But you have to--I presume you must 
be debating, as well, When is there moral significance to the 
youngest of humans? And you would agree, biologically, you 
became your person--you became your life when that union and 
fertilization occurred, biologically. You can just debate the 
theological position, but, biologically, you became genetically 
you at the moment of fertilization, biologically. That would be 
accurate, wouldn't it?
    Dr. Daley. I mean, yes, of course.
    Senator Brownback. So when scientific--when you--just in 
talking with your colleagues, or talking about, ``Well, OK, 
yes, obviously I was biologically me at the moment of 
conception,'' but I don't want to--I'm so--there's so much 
promise here, I want to set the date at this point in time, 
before we really attach moral significance to--what is this 
date that you would then attach, when you talk with your 
colleagues, moral significance to the youngest of humans?
    Dr. Daley. Honestly, I don't think any scientist can draw a 
line for you at when moral significance is endowed in the 
period of human development. It is not a line. But I think that 
we are all comfortable with the idea of using the earliest 
microscopic ball of cells in our research.
    From a biologist's perspective, life is, indeed, a 
continuum. We are all, in some way, shape, or form, descended 
from our original ancestors--Adam, Eve. Cells are immortal in 
the sense that through our line, we pass on life to our kids. I 
am mortal as a being, but, in seeing my children, I realize 
that we, as a species, are immortal. Life is in every cell. 
Every cell has the potential to give forth life. So these 
arguments about trying to get us to say, ``When does life 
begin,'' I think, is really defined in the realm of theology 
and the realm of things beyond biology.
    Senator Brownback. Well, you make it difficult for us, 
then, because, at some point in time, you gained moral 
significance. And you talked about teaching your boys baseball, 
which is such a pleasurable thing. And, at some point in time, 
they gained moral significance to you. Have you thought about 
when that line was?
    Dr. Daley. I'm really challenged by it. Yes. I'll tell you 
when I think about it. I think about it when I'm called to 
consult in our neonatal intensive-care unit--that's when I'm 
thinking about it--and you're seeing these tiny little 
premature babies, and it really calls into question, When is it 
that that life can exist independent of all of our technology? 
And when is it that you can actually hug that child and feel 
that it has significance?
    You know, I--when I--I can't hug an embryo. I just can't 
see it as morally equivalent to my kids and my patients. And my 
mission in stem cell research is aimed more at serving their 
needs.
    Senator Brownback. But you would agree, if your children 
were researched on at the blastocyst stage, they wouldn't be 
here.
    Dr. Daley. Yes.
    Senator Brownback. Nor would you, nor would I, at that 
point in time. And you're not willing to set for me, ``OK, at 
this point in time, moral significance begins to the''--and you 
and your colleagues don't particularly, I guess, discuss when 
this line is. You see the promise of the research, and you're 
looking--and I applaud your heart of, ``I want to cure 
people,'' because I want to cure people, too, and I'm glad 
you've got that heart. But you don't discuss about, ``OK, we 
would really put moral significance at this point in time, or 
that.''
    Dr. Daley. I think that there would be consensus among 
biologists that it would be impossible to define that time. 
There are definitions that, say, the British have assigned, 
through the Human Fertilization and Embryo Authority, which are 
convenient biological timelines, and the definition would be 14 
days, for instance, with a human embryo, which is about the 
time that the primitive streak forms, the earliest 
specialization of the embryo into the different tissue types. 
That's a matter of convenience. I don't think one is defining 
14 days as the point of moral significance; it just does allow 
us to say--certainly before that time, very few people would 
argue; after that time, I think it's impossible.
    Senator Brownback. All right, that's fair enough. I just--I 
would hope that your colleagues, as you discuss in your cell 
biology organization and others, would, you know, discuss 
about--this is a major issue. You obviously wouldn't want to 
research on somebody that's a full blown human being. You 
wouldn't want research on your children or yourself. You 
wouldn't want it on me, on my children. OK, we accept that. 
Then where can we, then, start researching on you without your 
permission? At what age?
    Dr. Daley. Right. I invite your opinion, as well as 
everyone else, to engage in that discussion. I don't think it's 
at the age of the blastocyst, however.
    Senator Brownback. But you're not willing to establish when 
I think this would or should----
    Dr. Daley. No. No. Sorry.
    Senator Brownback. All right, fair enough.
    Gentlemen, thank you very much. It's very illuminating. I'm 
delighted to hear about the potential for the use of fat. We 
have plenty of it in America. We have this huge obesity 
problem, and I'm hopeful for the day when we can use it to 
solve many of our maladies. The hearing's been excellent.
    The hearing's adjourned.
    [Whereupon, at 4:30 p.m., the hearing was adjourned.]
                            A P P E N D I X

              Prepared Statement of Frank R. Lautenberg, 
                      U.S. Senator from New Jersey
    Mr. Chairman:

    This hearing is entitled ``Embryonic Stem Cell Research: Exploring 
the Controversy.'' Frankly, if you ask me, there is no controversy 
here. Embryonic stem cell research is critical to our mission to fight 
and cure disease in this country.
    The debate over whether we should pursue adult stem cell research 
or embryonic stem cell research sets up a false choice.
    Both types of stem cell research should be pursued simultaneously. 
Each type of research offers the potential for cures; neither is a 
substitute for the other. No promising stem cell research should be 
stopped. The National Academy of Sciences has said as much.
    Stem cell research, particularly the burgeoning field of embryonic 
stem cell research, has tremendous potential to help up better 
understand, treat, and even cure deadly and disabling diseases like 
diabetes, cancer, Parkinson's Alzheimer's and multiple sclerosis. Stem 
cell research could help us cut the incidence of heart disease, the 
Nation's leading killer.
    Most American support embryonic stem cell research. Significantly, 
by a margin of 54 percent to 29 percent, Catholics support such 
research, according to a recent survey by Peter D. Hart Research 
Associates. The survey also indicated that the more people learn about 
the issue, the more they are inclined to support the research. I ask 
unanimous consent that the survey results appear in the hearing record 
following my statement.
    Members of Congress from both sides of the political aisle support 
the research, including our ``pro-life'' colleague, Senator Hatch, who 
stated that ``life begins in the womb, not in a petri dish.''
    Forty Nobel Laureates also support the research, as does former 
First Lady Nancy Reagan who spent ten years watching her husband suffer 
from Alzheimer's disease.
    Virtually every major medical, scientific, and patients' advocacy 
group supports embryonic stem cell research. I'm talking about the 
American Medical Association, the Federation of American Societies for 
Experimental Biology, the Juvenile Diabetes Research Foundation, and 
the Parkinson's Action Network.
    In my view, President Bush's stem cell research policy sacrifices 
sound science in favor of policy expediency. His policy is, in effect, 
denying tens of millions of people suffering from physically and 
mentally debilitating diseases, illnesses, and injuries from being 
cured.
    First Lady Laura Bush recently said, ``We don't even know that stem 
cell research will provide cures for anything--much less that it's very 
close'' to yielding major advances.
    What the First Lady is saying, in effect, is that because we don't 
know what the research will yield--and because it will take a long 
time--we shouldn't bother starting it. With all due respect, scientists 
disagree and that's not the sort of attitude that leads to scientific 
breakthroughs that improve life.
    I appreciate the sincerity of the views of those who oppose 
embryonic stem cell research, but I have met with too many diabetic 
children and their families. I have seen how they suffer and I simply 
cannot tell these children or their parents that in the hierarchy of 
rights, a week-old undifferentiated cell is more important than they 
are and cannot be used in research, treating, or possibly curing their 
terrible disease.
    The millions of men, women, and children who are suffering from 
diabetes and other life threatening diseases, illnesses, and injuries 
are engaged in a race against time. It is our responsibility to make 
sure that they and future generations benefit as quickly as possible 
from the wonders of modern science, medicine, and technology have to 
offer.
    Thank you, Mr. Chairman.
                                 ______
                                 

                  Voters' Views on Stem Cell Research

  Prepared by Peter D. Hart Research Associates for the Civil Society 
                         Institute--March 2004

Introduction
    From March 24 to 29, 2004, Peter D. Hart Research Associates 
conducted a telephone survey on behalf of the Civil Society Institute. 
This survey was conducted among registered voters in 18 states and was 
designed to explore public opinion on Federal funding for stem cell 
research. The states included were Ohio, Michigan, Pennsylvania, Maine, 
New Hampshire, Wisconsin, Minnesota, Iowa, Washington, Oregon, New 
Mexico, Nevada, Arizona, Florida, Louisiana, Arkansas, Missouri, and 
West Virginia. With 802 interviews, the margin of error for this survey 
is 3.5 percent, with larger margins of error for subgroups.
Knowledge and Impact of Stem Cell Issue
    Public knowledge of stem cell research has increased over the past 
few years. Three in four (76 percent) voters say that they have heard a 
lot or a little about medical research involving embryonic stem cells, 
up from 69 percent of voters nationally in August 2001. \1\ Nearly one-
third (31 percent) of voters affirm hearing a lot, an increase from 
August 2001 when 25 percent claimed the same level of knowledge about 
stem cell research.
---------------------------------------------------------------------------
    \1\ Virginia Commonwealth University survey, conducted 8/29-9/2/01; 
surveyed 1,122 adults nationwide; margin of error 3 percent 
(release, 10/4/01).
---------------------------------------------------------------------------
    Nearly all have a personal connection to the issue. Nearly every 
(86 percent) voter reports having a family member or close friend who 
potentially could benefit from stem cell research. More than two-thirds 
(68 percent) have some experience with cancer, and more than half (58 
percent) have been affected by heart disease. Aside from these two more 
widespread diseases, 49 percent of voters report having a close 
personal friend or family member who has suffered from Alzheimer's 
disease, Parkinson's disease, juvenile diabetes, or spinal cord 
injury--and thus could be affected by medical research on stem cells.
    Voters strongly support Federal funding for medical research. Even 
when compared with other items such as national defense, 
transportation, or education, 59 percent of voters say that Federal 
funding for medical research should be a high priority, including 31 
percent who say that it should be a very high priority. Another 35 
percent say that funding for medical research should be a moderate 
priority. Just 6 percent do not see medical research funding as a 
priority for the Federal government. Support is higher among Democrats 
(64 percent) than among Republicans (46 percent), and is highest among 
the politically important independents (67 percent).
    A majority of voters in these states support embryonic stem cell 
research.--Overall, voters favor stem cell research by 53 percent to 30 
percent. This is an increase in support from the August 2001 survey, 
when voters nationwide expressed support for embryonic stem cell 
research by only 48 percent to 43 percent.
    Democrats and Republicans offer different views on embryonic stem 
cell research (in the demographics portion of the survey, voters were 
asked whether they would describe their overall point of view in terms 
of the political parties as Democratic, Republican, or completely 
independent). Democrats favor stem cell research by a 46-point margin 
(65 percent to 19 percent), whereas Republicans oppose stem cell 
research by a nine-point margin (47 percent to 38 percent). However, 
independents have a view that is much closer to Democrats' than 
Republicans', as independent voters favor stem cell research by a 32-
point margin (55 percent to 23 percent). In political terms, the center 
of the electorate clearly embraces the importance of stem cell 
research.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Support increases with education level, as 63 percent of college 
graduates favor stem cell research compared with 48 percent of non-
college voters who say the same. Support is even higher among those 
with a postgraduate degree: nearly three in four (74 percent) say that 
they strongly or somewhat support embryonic stem cell research. Along 
gender lines, support is equal among men (53 percent) and women (53 
percent). College men (61 percent) are much more likely than are non-
college men (49 percent) to favor stem cell research, and the education 
gap is even greater among women, with 65 percent of college women and 
just 47 percent of non-college women favoring stem cell research.
    Dividing the states into regions shows that a majority of voters in 
the West (60 percent), rural Midwest (54 percent), Northeast (52 
percent), and South (52 percent) support stem cell research, along with 
a large plurality in the industrial Midwest (49 percent). Religion is 
another strong predictor of voters' views on stem cell research. As 
expected, support is low among Evangelical Protestants (34 percent) but 
much stronger among mainline Protestants (59 percent). Significantly, 
Catholics (54 percent) support stem cell research nearly as strongly as 
the mainline Protestants.
    Analysis also reveals that the more people have heard about the 
issue, the more they support stem cell research. Voters who say that 
they know a lot about the issue support stem cell research by 68 
percent to 26 percent, whereas voters who say that they know little 
about the issue support it by a much smaller 36 percent to 30 percent.
    Support grows with more information. Support for embryonic stem 
cell research increases 13 percentage points to 66 percent when people 
are informed that couples are donating unwanted embryos that otherwise 
would be discarded. After hearing a more detailed description of 
embryonic stem cell research and the diseases it can help cure, support 
grows even more. Overall, three in four (76 percent) voters support 
stem cell research after hearing the following description:

        Embryonic stem cells are special cells that can develop into 
        every type of cell in the human body. The stem cells are 
        extracted from frozen embryos in fertility clinics, donated by 
        couples who no longer want or need the embryo. This process 
        destroys the embryo. These stem cells can then reproduce on 
        their own, creating what is called a ``line'' of stem cells 
        that many researchers can work with. Scientists believe that 
        there is a good chance that stem cells can be developed into 
        cures or treatments for diseases such as cancer, Parkinson's, 
        Alzheimer's, juvenile diabetes, and spinal cord injuries.

    Clearly, the potential of stem cell research to produce treatments 
for a wide range of diseases and conditions is a very powerful 
consideration for voters. Even subgroups originally resistant to the 
idea, such as Evangelicals and Republicans, support stem cell research 
after hearing a description of the process and potential of the 
research, despite the explicit recognition of the embryo destruction 
required.
    A large majority of voters in these states would change the Bush 
Administration's August 2001 policy restricting embryonic stem cell 
research.--More than two-thirds (68 percent) of voters support the 
three longstanding criteria for Federal government funding of stem cell 
research: (1) the cells must come from an embryo that was created for 
reproductive purposes and is no longer needed, (2) researchers must 
obtain the consent of the couple donating the embryo, and (3) the 
donors cannot be paid for use of the embryo.
    In August 2001, the Bush Administration established a new 
restriction on Federal funding for embryonic stem cell research. This 
restriction says that research on stem cell lines created before August 
2001 can receive funding, but funding is prohibited for research on 
stem cell lines developed after that date. However, the survey results 
reveal that voters overwhelmingly oppose this restriction and favor 
funding for research using newer stem cell lines. Fully 65 percent 
support expanding Federal government funding for stem cell lines 
created after August 2001, including 50 percent who feel strongly, 
compared with only 17 percent who support maintaining the Bush 
Administration's August 2001 restrictions.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Key political groups, such as independents and persuadable voters, 
strongly support a policy allowing Federal funding for research on 
newer stem cell lines. As the accompanying table shows, the August 2001 
restrictions garner relatively little support even among groups not 
favorable to stem cell research initially, such as Republicans, 
Evangelicals, and conservatives.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    It is important to note that strong majorities of voters disagree 
with the two primary justifications for the August 2001 restriction: 1) 
that there are enough stem cell lines that were created before August 
2001 to support research needs, and 2) that the government should not 
create an incentive to destroy more embryos by funding research on 
them.
    On the topic of the number of viable stem cell lines available for 
research, voters were read statements from both supporters and 
opponents of the Bush Administration's August 2001 policy and were 
asked which statement they agree with more.

        Statement A: People who support the Bush Administration's 
        policy say that there already are sufficient embryonic stem 
        cell lines to meet the needs of researchers. The Bush 
        Administration's policy will allow stem cell research to move 
        forward and help cure diseases, without violating our ethical 
        standards by supporting the destruction of additional embryos.

        Statement B: People who support funding for research using 
        newer stem cell lines point out that when the Bush 
        Administration's policy was created, people thought there were 
        at least seventy stem cell lines available for research. But it 
        turns out there are only fifteen lines available, and almost 
        all researchers agree that many more are needed for stem cell 
        research to fulfill its promise. Given these new facts, we need 
        a new policy that allows life-saving research to proceed.

    Again, after hearing statements from both sides of the debate, a 
large majority (65 percent) agree with those who favor expanded funding 
for newer stem cell lines, with 49 percent who feel strongly. Fewer 
than one in four voters (23 percent) agree that funding should be 
limited to the old stem cell lines, including 16 percent who feel 
strongly.
    On the topic of destruction of embryos, voters again were presented 
with statements from opponents and supporters of expanding Federal 
funding for use in research on newer stem cell lines, and were asked 
which statement they agree with more.

        Statement A: People who support the Bush Administration's 
        policy say that funding for the old stem cell lines is right 
        because those embryos already had been destroyed, but if 
        funding is made available for research on newer stem cell lines 
        it will create an incentive for the destruction of additional 
        embryos. They say it is wrong for the government to support or 
        encourage the destruction of human embryos.

        Statement B: People who support Federal funding for research 
        using newer stem cell lines say these newer stem cells will 
        come from embryos in fertility clinics that are voluntarily 
        donated by couples who no longer need or want them and they 
        likely will be discarded. They say there are already tens of 
        thousands of such frozen embryos that will be discarded by 
        their donors if they are not used for research. It only makes 
        sense to use these embryos to cure diseases and save lives.

    Again, by a more than two to one, voters solidly agree with 
supporters of Federal funding on newer stem cell lines, as 66 percent 
of voters say that they agree with the supporters of expanded Federal 
funding, including 51 percent who strongly agree. On the other side of 
the coin, just 24 percent agree that funding should be limited to the 
old stem cell lines, including 18 percent who feel strongly.
    Voters in these states are more persuaded by arguments in favor of 
allowing research than by arguments in favor of the August 2001 
restriction.--The survey presented voters with the strongest arguments 
made by both sides of the stem cell debate. The most persuasive 
argument tested in favor of the Bush Administration's policy of limited 
funding for stem cell research is that there should be more 
comprehensive research on stem cell lines from adults, umbilical cords, 
and animals to gauge their usefulness before more embryos are 
destroyed. Half (50 percent) of voters find this argument very or 
fairly convincing, and a nearly equal proportion (47 percent) say that 
it is just somewhat or not at all convincing. Other arguments in favor 
of the administration's policy--that embryonic stem cell research is 
immoral, that it is possibly unethical, that it is exploitative of a 
human life--generally prove less persuasive to voters.

           Reasons to Support the Bush Administration's Policy
       (Proportion saying each is a very/fairly convincing reason)
------------------------------------------------------------------------

------------------------------------------------------------------------
50%                           In addition to embryonic stem cell lines,
                               there are many stem cell lines available
                               to researchers that come from adult
                               humans, umbilical cords that are
                               discarded after birth, and animals. We
                               should first see whether these stem cells
                               can provide the cures and treatments we
                               need, before destroying more human
                               embryos.

43%                           Under the current policy, there already
                               are sufficient stem cell lines available
                               for researchers to begin exploring the
                               potential of stem cell research. We do
                               not know yet whether additional stem cell
                               lines are needed, and until we do, we
                               should maintain the strongest protections
                               possible against exploitation of human
                               life.

35%                           For the sake of moral principle and human
                               dignity, it is time that we draw the
                               line. Banning Federal government funding
                               for research on newer stem cell lines is
                               a good way to make sure that embryos are
                               not created and destroyed for research
                               purposes.

32%                           Pro-life organizations believe that it is
                               immoral to destroy living human embryos,
                               even for medical research.

32%                           Research on embryonic stem cells raises
                               profound ethical questions, because
                               extracting the stem cell destroys the
                               embryo, and thus destroys its potential
                               for life. It is wrong to provide taxpayer
                               funding to research that sanctions and
                               encourages the future destruction of
                               human embryos.30%                           There is no such thing as an excess life,
                               and the fact that a living embryo is
                               going to be discarded does not justify
                               experimenting on it or exploiting it as a
                               natural resource.
------------------------------------------------------------------------

    Voters agree more with arguments for allowing research on newer 
stem cell lines. The most convincing argument is that embryonic stem 
cell research is similar to organ donation in that neither organ donors 
nor frozen embryos will live and that there is a great medical need for 
both (69 percent very/fairly convincing). Two-thirds (65 percent) of 
voters agree that our government should support rather than stand in 
the way of research that will help ease the suffering of more than 100 
million Americans who are suffering from diabetes, Alzheimer's, 
Parkinson's, and other diseases and conditions.

              Reasons to Fund Research on Newer Cell Lines
       (Proportion saying each is a very/fairly convincing reason)
------------------------------------------------------------------------------------------------------------------------------------------------
69%                           This issue is very similar to organ
                               donation. Neither frozen embryos nor
                               organ donors are going to live, and in
                               both cases there is an urgent medical
                               need that can be filled by the donation
                               of needed tissue. Just like organ
                               donation, stem cell research can save
                               millions of lives.65%                           Stem cell research offers the best hope we
                               have today for curing such diseases as
                               Alzheimer's, diabetes, heart disease, and
                               cancer, which today cause pain and
                               suffering to more than 100 million
                               Americans. Our government should be fully
                               supporting this research, not standing in
                               the way.63%                           Currently fertilization clinics in the
                               United States have tens of thousands of
                               embryos that have been donated by couples
                               who no longer need or want them. If these
                               embryos cannot be used in stem cell
                               research, they will simply be discarded
                               by the donors, and no benefits at all
                               will be derived from them.63%                           Highly respected organizations such as the
                               AMA, National Academy of Sciences,
                               National Institutes of Health, Juvenile
                               Diabetes Research Foundation, and
                               Alzheimer's Association strongly support
                               allowing research on newer stem cell
                               lines.58%                           Nancy Reagan, Michael J. Fox, and
                               Christopher Reeve all support funding for
                               research on newer stem cell lines,
                               because they know it represents the best
                               chance we have to prevent suffering from
                               Alzheimer's, Parkinson's disease, spinal
                               cord injuries, and other afflictions.56%                           When the Bush Administration's policy was
                               established, it was believed that there
                               were 78 stem cell lines available for
                               research. But it turns out there are only
                               15 lines that meet the Bush
                               Administration's conditions, and
                               researchers agree that many more are
                               needed to move forward with meaningful
                               stem cell research.
------------------------------------------------------------------------

    Sixty-three percent of voters are convinced by the argument that if 
embryos that donors no longer need are not used for research, fertility 
clinics will simply discard them with no benefit to medical research. 
An equal proportion find the support of the American Medical 
Association, the National Academy of Science, National Institutes of 
Health, the Juvenile Diabetes Research Foundation, and the Alzheimer's 
Association of research on new stem cell lines a convincing reason to 
lift the August 2001 restrictions on Federal funding.
    Many supporters of changing the August 2001 restriction are seen as 
highly trustworthy sources of information on the issue of stem cell 
research.--Two-thirds or more of voters say that they trust the 
information provided by a number of stem cell research supporters, 
including 87 percent who say they trust information from health 
organizations such as the American Medical Association and the 
Alzheimer's Association. Additionally, the opinions of celebrities who 
favor funding for newer cell lines, such as Mary Tyler Moore (75 
percent), chairwoman of the Juvenile Diabetes Research Foundation; 
Christopher Reeve (73 percent), founder of the Christopher Reeve 
Paralysis Foundation; Michael J. Fox (67 percent), founder of the 
Michael J. Fox Parkinson's Research Foundation; and Nancy Reagan (65 
percent) are considered trustworthy. These findings indicate that not 
only do the arguments in favor of expanded stem cell research resonate 
strongly with voters, they also consider the individuals and 
organizations making these arguments to be highly credible.
    After hearing arguments from both sides, support for research on 
new cell lines remains high.--Total support climbs four percentage 
points to 69 percent, and strong support increases eight points to 58 
percent, whereas support for the 2001 Bush Administration's policy is 
just 20 percent. Clearly, voters broadly favor dropping the August 2001 
Bush Administration restrictions and allowing research funding to 
include using newer stem cell lines. Further debate is likely to 
strengthen, not weaken, that consensus.

                                  
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