[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
__________
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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
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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.
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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)
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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.
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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.