[Senate Hearing 107-541]
[From the U.S. Government Publishing Office]
S. Hrg. 107-541
CLONING, 2002
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HEARINGS
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
__________
SPECIAL HEARINGS
JANUARY 24, 2002--WASHINGTON, DC
MARCH 12, 2002--WASHINGTON, DC
__________
Printed for the use of the Committee on Appropriations
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COMMITTEE ON APPROPRIATIONS
ROBERT C. BYRD, West Virginia, Chairman
DANIEL K. INOUYE, Hawaii TED STEVENS, Alaska
ERNEST F. HOLLINGS, South Carolina THAD COCHRAN, Mississippi
PATRICK J. LEAHY, Vermont ARLEN SPECTER, Pennsylvania
TOM HARKIN, Iowa PETE V. DOMENICI, New Mexico
BARBARA A. MIKULSKI, Maryland CHRISTOPHER S. BOND, Missouri
HARRY REID, Nevada MITCH McCONNELL, Kentucky
HERB KOHL, Wisconsin CONRAD BURNS, Montana
PATTY MURRAY, Washington RICHARD C. SHELBY, Alabama
BYRON L. DORGAN, North Dakota JUDD GREGG, New Hampshire
DIANNE FEINSTEIN, California ROBERT F. BENNETT, Utah
RICHARD J. DURBIN, Illinois BEN NIGHTHORSE CAMPBELL, Colorado
TIM JOHNSON, South Dakota LARRY CRAIG, Idaho
MARY L. LANDRIEU, Louisiana KAY BAILEY HUTCHISON, Texas
JACK REED, Rhode Island MIKE DeWINE, Ohio
Terrence E. Sauvain, Staff Director
Charles Kieffer, Deputy Staff Director
Steven J. Cortese, Minority Staff Director
Lisa Sutherland, Minority Deputy Staff Director
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Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
TOM HARKIN, Iowa, Chairman
ERNEST F. HOLLINGS, South Carolina ARLEN SPECTER, Pennsylvania
DANIEL K. INOUYE, Hawaii THAD COCHRAN, Mississippi
HARRY REID, Nevada JUDD GREGG, New Hampshire
HERB KOHL, Wisconsin LARRY CRAIG, Idaho
PATTY MURRAY, Washington KAY BAILEY HUTCHISON, Texas
MARY L. LANDRIEU, Louisiana TED STEVENS, Alaska
ROBERT C. BYRD, West Virginia MIKE DeWINE, Ohio
Professional Staff
Ellen Murray
Jim Sourwine
Mark Laisch
Adrienne Hallett
Erik Fatemi
Bettilou Taylor (Minority)
Mary Dietrich (Minority)
Sudip Shrikant Parikh (Minority)
Candice Rogers (Minority)
Administrative Support
Carole Geagley
C O N T E N T S
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Thursday, January 24, 2002
Page
Opening statement of Senator Tom Harkin.......................... 1
Opening statement of Senator Arlen Specter....................... 2
Statement of Irving Weissman, M.D., professor, Stanford
University..................................................... 4
Prepared statement........................................... 6
Statement of Rudolf Jaenisch, M.D., professor, Massachusetts
Institute of Technology........................................ 7
Don't Clone Humans!.......................................... 7
Prepared statement........................................... 11
Statement of Dr. Brent Blackwelder, president, Friends of the
Earth.......................................................... 15
Prepared statement........................................... 17
Statement of Dr. Maria Michejda, senior research advisor,
Immunology Center, Georgetown University Medical Center........ 20
Prepared statement........................................... 22
Tuesday, March 12, 2002
Opening statement of Senator Arlen Specter....................... 37
Statement of Hon. Connie Mack, former U.S. Senator from Florida.. 39
Prepared statement........................................... 41
Statement of Hon. Bart Stupak, U.S. Representative from Michigan. 43
Prepared statement........................................... 45
Statement of Gerald D. Fischbach, M.D., executive vice president
for Health and Biomedical Sciences, dean of the Faculty of
Medicine, Columbia University.................................. 52
Prepared statement........................................... 53
Statement of Silviu Itescu, M.D., director, Transplantation
Immunology, New York-Presbyterian Hospital, Columbia
University, NY................................................. 55
Prepared statement........................................... 57
Statement of Kevin Kline, actor.................................. 59
Prepared statement........................................... 61
Prepared joint statement of the Union of Orthodox Jewish
Congregations of America and the Rabbinical Council of America. 65
CLONING, 2002
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THURSDAY, JANUARY 24, 2002
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 11:01 a.m., in room-192, Dirksen
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
Present: Senators Harkin and Specter.
OPENING STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. This hearing of the Senate Labor, Health
and Human Services, and Education Appropriations Subcommittee
will come to order. This subcommittee, under the leadership of
Senator Specter and I, as we have changed positions over the
years, and with the help of our members of the subcommittee,
has been committed over these years to helping our top
scientists make medical breakthroughs to bring cures for killer
diseases like cancer and Alzheimer's, Parkinson's, stroke and
other debilitating illnesses and diseases. This hearing is part
of that effort, and focuses on the potential of new techniques
and how we might bridge deeply held beliefs to find common
ground to allow that research to move forward.
As we all know, these are extremely complex issues, and
scientists are announcing new advances practically every week.
Three years ago, Dr. Michael West of Advanced Cell Technology
testified before this committee about a new plan to transplant
a patient's DNA into a human egg, grow some stem cells, and
then use those cells to cure devastating diseases. It was a
plan that immediately brought hope to Americans suffering from
Alzheimer's and Parkinson's and juvenile diabetes, and spinal
cord injuries, to mention a few.
Well, late last year Dr. Michael West announced that he had
taken the first step toward reaching that amazing goal, but
with that announcement came a great deal of media attention
and, I might add, an avalanche of misinformation about what
that advance meant.
Since then, we have learned more about the science behind
Dr. West's announcement and the very different potential
applications of it. One potential application, of course, is
human cloning, a procedure designed to allow the birth of
cloned human babies. Human cloning worries most Americans,
including us here in Congress, including me. I firmly oppose
human cloning. I believe it should be banned.
However, the other potential application is far different.
Through what I will call therapeutic cellular transfer, or TCT,
our scientists may, indeed, unlock the cures for some of our
most devastating and debilitating diseases. As I said at our
last hearing, I believe it would be tragic to allow our outrage
about human cloning to blind us to the promise that TCT holds.
Late last week, a distinguished National Academy of Sciences
panel made up of many of our Nation's top doctors and
researchers, led by Dr. Irving Weissman, who is here today with
us, released an important new report that I hope will further
assist Senators and Congressmen in understanding the science
and crafting a decision about how we should proceed.
This report concludes what we in Congress collectively
agree. Human cloning should be outlawed. Stiff penalties should
be imposed on anyone who violates this law, but at the same
time, this report also makes clear the need for more research
to unlock the mysteries of diabetes and Alzheimer's and
Parkinson's and these other illnesses. It urges us to allow
this potential life-saving research to continue.
So today, Senator Specter and I, joined by other Senators,
are introducing legislation that would ban human cloning and
impose substantial criminal and civil penalties on any
misguided person who would attempt this type of procedure. Our
legislation slams the door on human cloning, but keeps it open
to life-saving medical research. Our legislation stands in
contrast to the position taken by our colleagues in the House,
a position which I understand some Senators also advocate. The
House bill would also stop vital medical research on stem cells
in its tracks. I personally believe that would be a tragic
mistake.
It is quite clear that this remains a controversial and
contentious issue. There are deeply held beliefs on both sides.
We must respect all points of view, and the debate may continue
for some time, so let us work together to move forward on what
we all agree on. That seems to be the common sense approach we
are going to take with the stimulus package. We all agree that
human cloning should be banned, so let us do that without
further delay.
We are fortunate to have with us this morning an
outstanding panel of witnesses that includes scientists on both
sides of this issue. Before we hear from them, I would invite
my ranking member and my colleague, Senator Specter, to make
any opening remarks. Senator Specter.
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Thank you very much, Mr. Chairman. This
subcommittee has taken the lead on increasing the funding for
the National Institutes of Health from $12 billion to $23
billion and has thus enabled the scientific community to make
enormous strides against the most dreaded diseases.
When stem cell research was disclosed in November 1998,
this subcommittee immediately started a series of hearings, and
today's is the 12th in that series. Examining the implication
of stem cell research, and what its potential might be. We have
worked with our colleagues in the Senate in the face of a
Federal prohibition against using Federal money to extract stem
cells from embryos, but permitting Federal funds to be used on
stem cell research after the cells were extracted. A
distinction which in my judgment does not make a whole lot of
sense, and we are moving ahead to try to make Federal funding
available for stem cell research generally.
We have 64 Senators who had signed on to broader use of
Federal funding on stem cell research, with 12 more Senators
being committed to that and willing to put it in writing. Last
spring and early summer, President Bush made his noted
presentation authorizing the use of Federal funds on stem cells
on the 64 existing lines. This subcommittee held further
hearings and my view was, I think, shared by our distinguished
chairman, that that distinction was too limited, but with the
events of 9/11, that has been very much pushed to the sideline.
Then, when there was consideration of the appropriations
bill last November, Senator Brownback offered amendments which
would not only ban reproductive cloning where there was general
agreement that it ought not to be done, but would also ban so-
called therapeutic cloning. I believe the scientists made a
public relations error of a very severe magnitude in calling it
therapeutic cloning. We are now using the term, nuclear
transplantation, which is really what it is, as opposed to
cloning, which has an opprobrious name and draws immediate
adverse reaction.
After a spirited debate on the floor, in consultation with
the majority Leader and the minority Leader, Senator Harkin, I,
and Senator Brownback agreed to delay the battle until February
or March of this year on the issue of nuclear transplantation,
and we are moving ahead now to go into that subject in some
detail. Senator Harkin has already noted the report of the
National Academy of Sciences on scientific and medical aspects
of human reproductive cloning, and we shall hear much more
about that today from Dr. Irving Weissman.
From the studies that I have undertaken, which have been
extensive, it seems to me that it is most unwise for the
politicians to limit the scientists on what the scientists can
do. Copernicus, Galileo, Pasteur, the scientists which have led
us to such remarkable achievements, would have been hamstrung
if decisions were to be made in legislative chambers or in town
meetings or with the emotional overtone that that imports, but
we have worked with all segments, and have invited witnesses
today to have a balanced panel in opposition to the views which
I have expressed so that we can make a rational judgment.
I noted in this morning's New York Times in an article by
Sheryl Gay Stolberg, who has been working on this subject for
perhaps as long or longer than the subcommittee has, the
conclusions of Ms. Judy Norsigian, a noted author of the book,
``Our Bodies, Ourselves,'' who concludes from a feminist point
of view that nuclear transplants place too much of a burden on
women. I will be interested to have an amplification on that
when the opportunity presents itself, but I think that adds
another dimension to the complexity of the issue.
But this is a continuing drama, continuing saga, so stay
tuned. We are going to find out all that we can so that when
the matter comes up in February or March we are in a position
to bring the best reasoning we can to this very important
subject, because millions of lives are at stake. When you talk
about nuclear transplantation, you are talking about a
procedure where a person who has Parkinson's donates their DNA,
which is combined with a donated egg to form an embryo from
which derived stem cells will not be rejected when used to cure
someone with Parkinson's, Alzheimer's, heart ailments, cancer,
or many, many other dreaded diseases.
This is a life or death matter, and we ought not to let
ideology determine it. That is my stated determination, and we
are moving forward on this important quest.
Thank you, Mr. Chairman.
Senator Harkin. Thank you, Senator Specter, and for your
leadership on this issue.
We will start with our panel. I will introduce them all
now, and we will just go down as I read them. First will be Dr.
Irving L. Weissman, a professor of cancer biology at Stanford
University School of Medicine, the chairman of the National
Academy of Sciences panel that just released the report on the
scientific and medical aspects of human cloning. Dr. Weissman
received his M.D. from Stanford University.
We welcome you, Dr. Weissman. Your statement will be made a
part of the record in its entirety, and we ask if you might
please sum it up for us. I would appreciate that. Dr. Weissman.
STATEMENT OF IRVING WEISSMAN, M.D., PROFESSOR, STANFORD
UNIVERSITY
Dr. Weissman. Thank you.
Mr. Chairman and members of the subcommittee, my name is
Irv Weissman. I am a professor at Stanford Medical School, and
my main research field for the last 20 years has been the
biology and transplantation of adult stem cells in mice and
humans. I am here as chair of the National Academy's panel on
scientific and medical aspects of human cloning, which released
its report on January 18, 2002.
The charge to the panel in June 2001 was to examine the
scientific and medical issues relative to human and
reproductive cloning, including the protection of human
subjects, and to clarify how human reproductive cloning differs
from stem cell research. Our charge did not extend to an
examination of the ethical issues related to human reproductive
cloning.
We needed to determine whether current methods for
reproductive cloning are scientifically feasible and
reproducible and medically safe. In addition, we needed to
examine whether human participants in the process could be
adequately advised and protected. Society and its leaders will
need such scientific and medical information if they are to
address the relevant ethical and public policy issues.
In reproductive cloning, the nucleus of a body cell is
transplanted into an egg whose nucleus has been removed,
stimulating it to divide to produce a roughly 150-cell
blastocyst embryo. The blastocyst is then placed into a uterus
with the intent of creating a newborn.
In a related but different procedure, cells are isolated
from a blastocyst derived by nuclear transplantation, and the
cells are used to produce stem cell lines. Such stem cells are
unspecialized cells that can develop into almost all kinds of
body cells.
In what is sometimes called therapeutic cloning, the donor
of a nucleus for transplantation to produce stem cells can be a
person in whom the stem cell daughter cells will be used to
regenerate damaged tissues.
But there is another medical use for transplantation to
produce stem cells. Stem cells derived from a body cell or a
diseased cell of a patient who had inherited the risk for that
disease could be powerful tools for medical research and lead
to improved therapies.
We studied the scientific and medical literature, and held
a workshop with world leaders in the relevant technologies.
Among the participants were persons who planned to clone human
beings. The data from animal studies of reproductive cloning
demonstrate that only a small percentage of the attempts are
successful, that many of the resulting clones die during all
stages of gestation pregnancy, that newborn clones often are
abnormal, or die, and that the procedures carry serious risks
for the mother. However, the data on nuclear transplantation to
produce stem cells show that these cells are functional.
Given these findings, the panel unanimously approved the
following recommendations. Human reproductive cloning should
not now be practiced. It is dangerous, and likely to fail. The
panel therefore unanimously supports the proposal that there
should be a legally enforceable ban on the practice of human
reproductive cloning.
The scientific and medical considerations--that is what we
considered--related to the ban should be reviewed within 5
years. The ban itself should be reconsidered only if these two
conditions are met. First, a new scientific and medical review
indicates that the procedures are likely to be safe and
effective and, second, a broad national dialogue on the
societal, religious, and ethical issues suggests that a
reconsideration of the ban is warranted.
Finally, the scientific and medical considerations that
justify a ban on human reproductive cloning at this time are
not applicable to nuclear transplantation to produce stem
cells. Because of the considerable potential for developing new
medical therapies for life-threatening diseases, and advancing
fundamental knowledge, the panel supports the conclusion of a
recent National Academy report that recommended that biomedical
research using nuclear transplantation to produce stem cells be
permitted. A broad national dialogue on the societal,
religious, and ethical issues is encouraged in this matter.
So that is the end of our recommendations.
Scientists place high value on the freedom of inquiry, a
freedom that underlies all forms of scientific and medical
research. Recommending restrictions of research is a serious
matter, and the reasons for such a restriction must be
compelling. In the case of human reproductive cloning, we are
convinced that the potential dangers to the implanted fetus, to
the newborn, and to the woman carrying the fetus constitute
just such compelling reasons. In contrast, there are no
scientific or medical reasons to ban nuclear transplantation to
produce stem cells, and such a ban would certainly close
avenues of promising scientific and medical research.
The panel stressed that all concerned segments of society
should examine and debate the broad societal and ethical issues
associated with human reproductive cloning as well as those
associated with nuclear transplantation to produce stem cells.
We hope our report will help this subcommittee and President
Bush's Council on Bioethics in this regard.
prepared statement
Thank you for the opportunity to testify. I am glad that
this statement, and I hope the panel report also, can be placed
into the record. I will be happy to answer any questions.
[The statement follows:]
Prepared Statement of Irving L. Weissman
Mr. Chairman and members of the Subcommittee. My name is Irv
Weissman. I am a professor at Stanford Medical School, and my main
research field for the last 20 years has been the biology and
transplantation of adult stem cells in mice and humans. I am here as
chair of the National Academies Panel on Scientific and Medical Aspects
of Human Cloning, which released its report on January 18, 2002.
The charge to the panel in June 2001 was to examine the scientific
and medical issues relevant to human reproductive cloning, including
the protection of human subjects, and to clarify how human reproductive
cloning differs from stem cell research. Our charge did not extend to
an examination of the ethical issues related to human reproductive
cloning.
We needed to determine whether current methods for reproductive
cloning are scientifically feasible and reproducible and are medically
safe. In addition, we needed to examine whether human participants in
the process could be adequately advised and protected. Society and its
leaders will need such scientific and medical information if they are
to address the relevant ethical and public-policy issues.
In reproductive cloning, the nucleus of a body cell is transplanted
into an egg whose nucleus had been removed, stimulating it to divide to
produce a blastocyst embryo; the blastocyst is then placed into a
uterus with the intent of creating a newborn.
In a related but different procedure, cells are isolated from a
blastocyst derived by nuclear transplantation, and the cells are used
to produce stem cell lines. This is shown in the figure. Such stem
cells are unspecialized cells that can develop into almost all kinds of
body cells. In what is sometimes called therapeutic cloning, the donor
of a nucleus for transplantation to produce stem cells can be a person
in whom stem cell daughter cells will be used to regenerate damaged
tissues. There is another medical use for nuclear transplantation to
produce stem cells; stem cells derived from a body cell or a disease
cell of a patient who had inherited the risk for that disease could be
powerful tools for medical research and lead to improved therapies.
We studied the scientific and medical literature and held a
workshop with world leaders in the relevant technologies. Among the
participants were persons who planned to clone human beings. The data
from animal studies of reproductive cloning demonstrate that only a
small percentage of the attempts are successful, that many of the
resulting clones die during all stages of gestation, that newborn
clones often are abnormal or die, and that the procedures carry serious
risks for the mother. However, the data on nuclear transplantation to
produce stem cells show that these cells are functional.
Given those findings, the panel unanimously approved the following
recommendations:
Human reproductive cloning should not now be practiced. It is
dangerous and likely to fail. The panel therefore unanimously supports
the proposal that there should be a legally enforceable ban on the
practice of human reproductive cloning.
The scientific and medical considerations related to this ban
should be reviewed within five years. The ban itself should be
reconsidered only if at least two conditions are met: (1) a new
scientific and medical review indicates that the procedures are likely
to be safe and effective, and (2) a broad national dialogue on the
societal, religious, and ethical issues suggests that a reconsideration
of the ban is warranted.
Finally, the scientific and medical considerations that justify a
ban on human reproductive cloning at this time are not applicable to
nuclear transplantation to produce stem cells. Because of the
considerable potential for developing new medical therapies for life-
threatening diseases and advancing fundamental knowledge, the panel
supports the conclusion of a recent National Academies report that
recommended that biomedical research using nuclear transplantation to
produce stem cells be permitted. A broad national dialogue on the
societal, religious, and ethical issues is encouraged on this matter.
Scientists place high value on the freedom of inquiry--a freedom
that underlies all forms of scientific and medical research.
Recommending restriction of research is a serious matter, and the
reasons for such a restriction must be compelling. In the case of human
reproductive cloning, we are convinced that the potential dangers to
the implanted fetus, to the newborn, and to the woman carrying the
fetus constitute just such compelling reasons. In contrast, there are
no scientific or medical reasons to ban nuclear transplantation to
produce stem cells, and such a ban would certainly close avenues of
promising scientific and medical research.
The panel stressed that all concerned segments of society should
examine and debate the broad societal and ethical issues associated
with human reproductive cloning, as well as those associated with
nuclear transplantation to produce stem cells. We hope our report will
help this Subcommittee and President Bush's Council on Bioethics in
this regard.
Thank you for the opportunity to testify. I hope that my statement
and the panel report can be put into the record. I will be happy to
answer questions.
Senator Harkin. Dr. Weissman, thank you very much.
Next, we call on Dr. Rudolf Jaenisch, a founding member of
the Whitehead Institute, and a professor of biology at the
Massachusetts Institute of Technology. Dr. Jaenisch received
his M.D. from the University of Munich. He has done extensive
research with mice on cancer and on cloning.
Dr. Jaenisch, welcome. Please proceed.
STATEMENT OF RUDOLF JAENISCH, M.D., PROFESSOR,
MASSACHUSETTS INSTITUTE OF TECHNOLOGY
Dr. Jaenisch. Thank you, Mr. Chairman. I am a professor of
biology at the Whitehead Institute, and I am a basic scientist
with a long-term interest in embryonic development and recently
in the cloning of mice. I do not work with human embryonic stem
cells or therapeutic cloning, but these are the two issues I
want to comment on.
First, reproductive cloning. Last year, I gave testimony
before the House and the Senate subcommittee, and for
scientific reasons I warned human cloning would be
irresponsible and reckless. Together with Ian Wilmut, I wrote
an article for Science where we summarized our concerns, and I
would like to submit this article for the record.
Senator Harkin. Without objection.
[The information follows:]
[From Science, March 2001]
Don't Clone Humans!
(By Rudolf Jaenisch and Ian Wilmut) *
The successes in animal cloning suggest to some that the technology
has matured sufficiently to justify its application to human cloning.
An in vitro fertilization specialist and a reproductive physiologist
recently announced their intent to clone babies within a year's
time.\1\ There are many social and ethical reasons why we would never
be in favor of copying a person. However, our immediate concern is that
this proposal fails to take into account problems encountered in animal
cloning.
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* R. Jaenisch is at the Whitehead Institute for Biomedical Research
and Department of Biology, MIT, Cambridge, MA 02142,USA. I. Wilmut is
at the Roslin Institute, Roslin, Midlothian EH25 9PS,UK.
\1\ A. Stern, Boston Globe, 27 January 2001, p. A7.
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Since the birth of Dolly the sheep,\2\ successful cloning has been
reported in mice,\3\ cattle,\4\ goats,\5\ and pigs,\6\ \7\ and enough
experience has accumulated to realize the risks. Animal cloning is
inefficient and is likely to remain so for the foreseeable future.
Cloning results in gestational or neonatal developmental failures. At
best, a few percent of the nuclear transfer embryos survive to birth
and, of those, many die within the perinatal period. There is no reason
to believe that the outcomes of attempted human cloning will be any
different. The few cloned ruminants that have survived to term and
appear normal are often oversized, a condition referred to as ``large
offspring syndrome''.\8\ Far more common are more drastic defects that
occur during development. Placental malfunction is thought to be a
cause of the frequently observed embryonic death during gestation.
Newborn clones often display respiratory distress and circulatory
problems, the most common causes of neonatal death. Even apparently
healthy survivors may suffer from immune dysfunction, or kidney or
brain malformation, which can contribute to death later. So, if human
cloning is attempted, those embryos that do not die early may live to
become abnormal children and adults; both are troubling outcomes.
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\2\ I.Wilmut et al., Nature 385, 810 (1997).
\3\ T.Wakayama et al., Nature 394, 369 (1998).
\4\ Y. Kato et al., Science 282, 2095 (1998).
\5\ A. Baguisi et al., Nature Biotech vol. 17, 456 (1999).
\6\ I. Polejaeva et al., Nature 407,86 (2000).
\7\ A. Onishi et al., Science 289, 1188 (2000).
\8\ L. E.Young et al., Rev. Reprod. 3, 155 (1998).
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The fetal abnormalities and abnormalities in those few clones that
are born live are not readily traceable to the source of the donor
nuclei. The most likely explanation may be failures in genomic
reprogramming. Normal development depends upon a precise sequence of
changes in the configuration of the chromatin and in the methylation
state of the genomic DNA. These epigenetic alterations control tissue-
specific expression of genes. For cloning technology, the crucial
question is a simple one: Is the configuration of chromatin changes
acquired by a donor nucleus in the injected oocyte functionally
identical to that resulting from gametogenesis and fertilization?
Epigenetic reprogramming is normally accomplished during
spermatogenesis and oogenesis, processes that in humans take months and
years, respectively. During nuclear cloning, the reprogramming of the
somatic donor nucleus must occur within minutes or, at most, hours
between the time that nuclear transfer is completed and the onset of
cleavage of the activated egg begins. Prenatal mortality of nuclear
clones could be due to inappropriate reprogramming, which could lead in
turn to dysregulation of gene expression. Some long-term postnatal
survivors are likely to have subtle epigenetic defects that are below
the threshold that threatens viability.
Circumstantial evidence begins to hint at defects in programming of
gene expression in cloned animals.\9\ \10\ Expression of imprinted
genes was significantly altered when mouse or sheep embryos were
cultured in vitro before being implanted into the uterus.\11\ \12\
Thus, even minimal disturbance of the embryo's environment can lead to
epigenetic dysregulation of key developmental genes. Also, preliminary
observations suggest that widespread gene dysregulation in cloned mice
is associated with neonatal lethality.\13\
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\9\ P. De Sousa et al., Cloning 1, 63 (1999).
\10\ R. Daniels et al., Biol. Reprod. 63, 1034 (2000).
\11\ S. Khosla et al., Biol. Reprod. 64, 918 (2001).
\12\ L. E.Young et al., Nature Genet.27,153 (2001).
\13\ R. Jaenisch et al., unpublished observations.
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There is every reason to think that the human cloning experiments
announced by P. Zavos and S. Antinori will have the same high failure
rates as laboratories have experienced when attempting animal cloning.
Zavos tried to reassure the public by saying that: ``We can grade
embryos. We can do genetic screening. We can do quality control.'' \1\
The implication is that they plan to use the methods of routine
prenatal diagnosis employed for the detection of chromosomal and other
genetic abnormalities. However, there are no methods available now or
in the foreseeable future to examine the overall epigenetic state of
the genome.
Public reaction to human cloning failures could hinder research in
embryonic stem cells for the repair of organs and tissues. Research is
being conducted into programming these cells to turn into specific
tissues types, which could (for example) be used to regenerate nerve
cells and those in the heart muscle, benefiting patients with
Parkinson's, Alzheimer's, and heart disease. The potential benefit of
this therapeutic cell cloning will be enormous, and this research
should not be associated with the human cloning activists.
We believe attempts to clone human beings at a time when the
scientific issues of nuclear cloning have not been clarified are
dangerous and irresponsible. In the United States, the National
Bioethics Advisory Commission \14\ reached that conclusion 5 years ago,
``At present, the use of this technique to create a child would be a
premature experiment that would expose the fetus and the developing
child to unacceptable risks.'' All the data collected subsequently
reinforce this point of view.\15\
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\14\ NBAC, Executive Summary, Cloning Human Beings http://
bioethics.gov/pubs.html, p. ii (June 1997).
\15\ We thank R. Weinberg, G. Fink, D. Page, A. Chess, W. Rideout,
L. Young, H. Griffin, and L. Paterson.
Dr. Jaenisch. Over the last year, we and others have
gathered hard molecular data, and today we can state with
certainty that there are widespread abnormalities in gene
expression in cloned animals. The new data are entirely
consistent with my belief that even without overt disease, most
or all cloned animals will have defects of one kind or another,
so in summary, all evidence from animal experiments argues that
reproductive cloning of humans is irresponsible and should not
be pursued.
I support, however, therapeutic applications of nuclear
transfer, sometimes called therapeutic cloning, or TCT. The
therapeutic cloning approach combines nuclear transfer and
embryonic stem cells. Embryonic stem cells derived from early
embryos, and they are capable of generating any cell type of
the body, and can provide unlimited tissue types that can be
used for tissue replacements in conditions such as Parkinson's,
or liver cirrhosis, or Alzheimer's.
Therapeutic cloning combines these two techniques with
nuclear transfer with the goal of creating a customized stem
cell line for a needy patient. For instance, if one of you is
severely diabetic, this approach would take a cell, let us say
from a skin biopsy, take the nucleus from this skin cell, and
transfer this nucleus into an egg from which its own nucleus
had been removed. If the nucleus of your skin cell is exposed
to the nucleus from the egg, it reverts to its embryonic state.
Your skin cell begins to re-express those genes that it
expressed when it, itself, was an embryo. Whether this cell
that results from this process is a new embryo or a skin cell
rejuvenated is as much a question of philosophy as of science.
The cloned cells are cloned in a Petri dish. They give rise
to an embryonic stem cell line that can be induced to insulin-
producing cells and then planted into you, not rejected,
because they are from your own body.
Therapeutic cloning raises scientific and ethical concerns,
and I want to address some of these concerns that have been
subject to public debate that often ignores underlying
scientific and biological issues.
First, an important concern is that the use of embryos that
have the potential to develop into a human being is the source
to derive a cell line. I want, based upon biological facts, to
emphasize a critical distinction between therapeutic cloning
and the derivation of embryonic stem cells from a fertilized
embryo which was generated by in vitro fertilization. I should
remind you that all existing human embryonic stem cells have
been derived from IVF embryos. In IVF, the embryo has a unique
combination of genes that has not existed before and will not
exist again, and secondly, this embryo has a very high
potential to develop into a healthy baby if implanted.
In therapeutic cloning, the embryo first has the identical
combination of genes as the donor. Therefore, the cloned embryo
does not represent the creation of a new, unique life form,
but, rather, the programming and rejuvenation of an existing
cell from your body. One could argue it is a special form of
transplantation.
Second, the cloned embryo has a very low potential to ever
develop into a normal person, if implanted, because the
overwhelming majority of clones do not gestate normally, and
will be abnormal.
The generation of embryonic stem cells from cloned
blastocysts for the purpose of therapeutic cloning would appear
to me to pose fewer ethical problems than the generation of
embryonic stem cells from an in vitro fertilized embryo. The
majority of people in this country appear to accept the
generation of embryonic stem cells from left-over IVF embryos
if they are not implanted and would be destined for
destruction.
Another concern is that most animals derived by nuclear
transfer have serious abnormalities and die early in
development, and probably some of these abnormalities are
related to abnormal imprinting. This begs the question, would
differentiated cells derived from a cloned embryonic stem cell
cause similar abnormalities when transplanted to a patient?
Now, from all the evidence we have gathered over the last
year from our own laboratory and from others, I think I can
state with confidence that there are no principal scientific
reasons that would limit the use of embryonic stem cells for
tissue repair.
An alternative to embryonic stem cells has attained much
attention, which are adult stem cells. Can they provide another
source for transplantation? Adult stem cells are derived from a
variety of tissues. They have a surprising property to
differentiate into functional nerve cells or heart cells that
could be transplanted. The question is whether the promise of
adult stem cells is so great as to eliminate a need for
research on embryonic stem cells.
The field of adult stem cells is very exciting, but very
young indeed. With the exception of bone marrow cells, stem
cells, most adult somatic stem cells from other tissues remain
poorly defined, difficult to purify, and cannot be grown in
culture, and their clinical value has not been established. In
contrast, embryonic stem cells have been intensely studied for
more than 20 years, can be grown indefinitely in culture in
some homogenous populations, and have been shown to generate
all tissue types of the body.
To conclude, it would be unfortunate to stop research on
embryonic stem cells because of the unrealized potential of
adult stem cells. Research in both fields should proceed with
high priority.
How do other countries deal with this problem? I think the
British solution is a very reasonable one. Cloning of a human
embryo for the purpose of creating a person, reproductive
cloning, is criminal, but cloning of an embryo for therapeutic
purposes is permitted. The dividing line between criminal and
permitted manipulation is a clear one, implantation of the
cloned embryo into the womb. Implantation of a cloned embryo is
not permitted, is criminal, but its plantation into a Petri
dish is permitted. I believe that this dividing line between
criminal and permitted manipulation is clearly defined, and
makes biological sense.
The main question U.S. legislators have to struggle with
when making a decision is this one. Do we want to close a door
to the most advanced and promising research and deny many known
suffering patients the route for potential cure?
To criminalize therapeutic cloning in this country poses
serious ethical problems. Given that adult stem cell research
is in its infancy and cannot be predicted what or when
therapeutic application will be delivered, can we afford to
wait until this field has matured? Do you want to tell patients
who now suffer debilitating diseases that they will have to
wait for an unspecified number of years until the technical
problems of adult stem cells may have been resolved? In
contrast, a patient with the same disease in Britain may be
able to use a stem-cell-based therapy in a few years to come.
Unfortunately, the public discussion of therapeutic cloning
suffers from serious misconceptions. Often, reproductive
cloning is not differentiated from therapeutic cloning. The
word, cloning, provokes negative emotional reactions. A better
term would be, indeed, nuclear transplantation of stem cells.
I am concerned that the revulsion against reproductive
cloning rather than objective reasons may lead to legislative
actions that might impede potentially promising research. It
would be unfortunate, indeed, if legislative decisions would be
based on emotion rather than objective criteria.
I want to make a final point. In the 1970s, when IVF became
available as a reproductive technology, federally funded
research was not permitted in this country, in contrast to
European countries. The result was that IVF was practiced in
the private sector and lacked proper supervision. As a
consequence, even today, the activities of many fertility
clinics are obscure, unsupervised, and lack public scrutiny.
prepared statement
It would be unfortunate if a similar mistake were made with
therapeutic cloning. I believe you should proceed with this
research under tight regulation. The work should be supported
by Federal funding, and peer reviews should be conducted in
academic institutions of the highest standing that are bound to
follow scientific and ethical standards and are subject to
public scrutiny.
Thank you.
[The statement follows:]
Prepared Statement of Rudolf Jaenisch
I am a professor of biology at the Whitehead Institute and MIT,
Boston. I am a basic scientist with a long-term interest in
understanding the mechanisms of mammalian development. In recent years
my research has focused on the cloning of mice with the goal to
understand the reasons why the great majority of cloned animals are
abnormal. Most of my funding comes from Federal sources through peer
reviewed grants from the NIH. My laboratory does not use human ES cells
nor is it involved with the reproductive or therapeutic cloning of
humans. These are, however, the two issues I want to address in my
remarks.
reproductive cloning
In March last year I gave testimony before the House Subcommittee
on Energy and Commerce and before the Senate Subcommittee on Commerce,
Science and Space: for scientific reasons I warned that any proposal to
create humans by cloning would be irresponsible and reckless. Together
with Ian Wilmut, who generated Dolly, I wrote an article for Science
magazine where we summarized our concerns and I would like to submit
that article for the records. Last year, no concrete evidence on gene
expression in cloned animals was available and we could not base our
opinion on hard molecular data. Since last year we and others have
gathered hard molecular data and today we can state with certainty that
there are widespread abnormalities in gene expression in cloned
animals. For example, a recent study published in Science found that
the expression patterns of a majority of the genes examined in the
placentas of cloned mice were abnormal. These new data are entirely
consistent with my belief that even without overt disease, virtually
all cloned animals will have defects of one kind or another. Activists
who push for human cloning at this point in time ignore the very
worrisome scientific evidence that cloning is unsafe.
In summary, all evidence from animal experiments argues that
reproductive cloning of humans is irresponsible and should not
be pursued
My stance is clear: As a matter of science and as a personal
conviction, I am opposed to human reproductive cloning. However, I am
just as staunchly supportive of therapeutic applications of nuclear
transfer, sometimes called therapeutic cloning. I believe it would be
unfortunate if the door was closed to therapeutic cloning, as this
would have grave consequences for an extremely promising new field of
medical research. This is the topic I want to focus on.
therapeutic cloning
The therapeutic cloning approach is based on embryonic stem cells
as discussed below.
Embryonic Stem cells.--These cells are derived from early embryos
and they are cells capable of generating any cell type of the body.
Discovered 20 years ago in mice and subject to extensive research, we
can predict today with some confidence that these cells can provide
unlimited number of cells of any tissue type that can be used for
tissue replacement in conditions such as Parkinsons, diabetes,
Alzheimers, liver cirrhosis etc. The available evidence suggests that
human embryonic stem cells have a similar potential.
Therapeutic cloning.--The technique of therapeutic cloning combines
nuclear cloning and embryonic stem cell research, with the goal of
creating a customized stem cell line for a needy patient. For instance,
if one of you is severely diabetic, in this approach we would begin by
taking one of your cells, perhaps from a skin biopsy or blood sample,
and isolate its nucleus the core of the cell that carries the
chromosomes and all the genetic material. We would then inject your
nucleus into an egg whose own nucleus, or genetic material, has been
removed. The egg might come from a family member, a wife or daughter
who would view the egg donation in the same light as a donation of an
organ, a kidney or a liver or perhaps bone marrow or blood. When the
nucleus of your skin or blood cell is exposed to signals in the egg, it
reverts to its embryonic state and your skin or blood cell begins to
re-express the genes that it expressed when it was an embryo. Whether
the cell that results from this process is your skin cell rejuvenated
or a new embryo is as much a question of philosophy as of science. The
methods are similar to the initial manipulations in reproductive
cloning, but the intent is to generate cells for transplantation, not a
human being. The cloned cells are grown in the petri dish for a few
days, and instead of being implanted into the uterus of a woman, are
cultured to generate an embryonic stem cell. This ES cell would match
your body perfectly because it is your tissue. We would then coax the
ES cells to differentiate in culture to insulin-producing cells, that
we could then implant into you without fearing rejection and without
the need to treat you with immune suppressive agents. Thus, the
embryonic stem cells created by therapeutic cloning are of exclusive
benefit to you--the nuclear donor and the recipient of the therapy
patient. This contrasts with conventional organ transplantations where
often poorly matched donors have to be used leading to major
complications due to organ rejection and the use of immunosuppressive
drugs.
Therapeutic cloning raises scientific and ethical concerns and I
want to address some of these concerns that have been subject to a
public debate that often ignores the underlying scientific and
biological issues. The following questions are relevant for the
potential use of the technology for tissue replacement in human
patients.
1. An important issue in this debate is the concern of using
embryos that have the potential to develop into a human being as a
source for the generation of a cell line. I want, based upon biological
facts, to emphasize a critical distinction between therapeutic cloning
and the derivation of embryonic stem cells from a fertilized embryo
derived by in vitro fertilization (IVF). All existing human embryonic
stem cells have been derived from IVF embryos that were not implanted
into the uterus. I want to stress two important differences between
embryonic stem cells created by IVF or by therapeutic cloning.
(a.) In IVF the embryo (i) has a unique combination of genes that
has not existed before and (ii) has a high potential to develop into a
healthy baby when implanted.
(b.) In therapeutic cloning the embryo (i) has the identical
combination of genes as the donor. Therefore, the cloned embryo does
NOT represent the creation of a unique new life but rather the
reprogramming and rejuvenation of an existing cell from your body. One
could argue that this is a special form of autologous transplantation
meaning derived from ones own tissues, which is already widely used in
bone marrow, blood, and skin transplantation. (ii) The cloned embryo
has a very low potential to ever develop into a normal person, because
the overwhelming majority of clones do not gestate normally.
The majority of people in this country appear to accept the
generation of embryonic stem cells from `` left over'' IVF embryos that
are not implanted into the womb but would be destined for destruction.
The generation of embryonic stem cells from cloned blastocysts for the
purpose of therapeutic cloning would appear to pose fewer ethical
problems than the generation of embryonic stem cells from IVF embryos.
2. Most animals cloned by nuclear transfer have serious
abnormalities and die early in development. This begs the question:
Would differentiated cells derived from embryonic stem cells that have
been created by nuclear transfer cause similar abnormalities when
transplanted into a human patient? Another question was raised by
results from my laboratory showing that an important classes of
embryonically regulated, imprinted genes are dysregulated in mouse
embryonic stem cells, a condition termed epigenetic instability. This
evoked an additional concern: Does the epigenetic instability of
imprinted genes interfere with their potential use in tissue
replacement?
The most serious abnormalities in cloned animals are caused by
faulty reprogramming leading to abnormal regulation of genes that are
important for the development of a whole embryo. In contrast, when an
embryonic stem cell is differentiated in culture to functional tissue
cells such as nerve cells, heart muscle cells or beta cells of the
pancreas, these developmental genes need not be expressed (because no
embryo is generated). Similarly, the faithful expression of imprinted
genes is crucial for embryonic development but has probably little if
any role for the proper functioning of adult somatic cells. Therefore,
problems seen in cloned animals are not expected to affect the function
of cells that are derived from cloned embryonic stem cells.
I want to emphasize the difference between generating a cloned
animal from a embryonic stem cell nucleus by cloning and the
transplantation of differentiated cells derived from the embryonic stem
cells. In cloning, the donor nucleus must direct the development of an
embryo and of all organs, and faulty reprogramming of the genome causes
serious abnormalities in the cloned animal. This is not the case in
tissue transplantation where the cells derived from the embryonic stem
cell are introduced into a patient, i.e. in an organism that has been
derived from a fertilized egg. The extensive experience with mouse
embryonic stem cells over the last 20 years indicates that no
abnormalities arise when ES cells are introduced into a normal embryo
to form ``chimeric mice'' (as routinely used for gene targeting) or
into an adult mouse. Therefore, it is not to be expected that
epigenetic instability, if indeed found to be a property of human ES
cells, would create a problem for transplantation.
In summary, I do not see principal scientific reasons that would limit
the use of ES cells for tissue repair
Adult stem cells.--An alternative to embryonic stem cells that has
attained much attention are adult stem cells: can they provide another
source for transplantation? Adult stem cells are isolated from a
variety of tissues. They have the surprising ability to differentiate
into functional cells such as nerve cells or heart muscle cells and
even may have the potential to generate functional cells of tissue
types other than that of their own origin. The hope is that such cells
can be isolated from the adult and can serve as a source for
transplantation. As with therapeutic cloning, the cells would be
accepted by the patient but their generation would not involve the
creation of a cloned embryo and thus would pose no ethical problems.
Clearly, the recent work on adult stem cells is very exciting and
may even be revealing novel biological paradigms. Research on adult
stem cells should be supported with great vigor. The question however,
is whether the promise of adult stem cells to provide tissue repair is
so great as to eliminate the need for research on embryonic stem cells.
As a scientist with a broad perspective on these issues, let me give
you my opinion.
The field of adult stem cell research is really very young. With
the exception of bone marrow stem cells, which have been used for
decades in bone marrow transplantation in the clinic, most adult
somatic stem cells of other tissues were discovered only in the past
few years and they remain poorly defined. Adult somatic stem cells for
the brain, liver, pancreas, and skin among others are rare, difficult
to purify and in most cases, are challenging to grow in culture. Adult
stem cells have not been found in all tissues, and the clinical value
of the ones we have at hand has not been established.
Embryonic stem cells have been intensively studied for more than 20
years. Embryonic stem cells, in contrast to adult stem cells, grow
indefinitely in culture as homogeneous populations and have been shown
to generate all tissue types of the body. Much progress has been made
to direct differentiation to desired tissue types. Thus, we can be
confident that embryonic stem cells represent the precursors of all
tissues and that through research, tissue replacement will be realized
in the future.
In conclusion, it would be unfortunate to stop research on embryonic
stem cells because of the unrealized potential of adult stem
cells. Research in both fields should proceed with high
priority
The British solution to embryonic stem cell work and therapeutic
cloning is a reasonable one: Cloning of a human embryo for the purpose
of creating a person (reproductive cloning) is criminal but cloning of
an embryo for therapeutic purpose is permitted (therapeutic cloning).
The dividing line between criminal and permitted cloning is a clear
one: the implantation of the cloned embryo into the womb. Implantation
of a cloned embryo is not permitted but explantation into a petri dish
with the intent to derive an embryonic stem cell for therapeutic
purpose is permitted. I believe that this dividing line between
criminal and permitted manipulation of a human embryo is clearly
defined and makes biological sense.
The main question you as legislators have to struggle with when
making a decision is this one: do you want to close the door to the
most advanced and promising research and deny the many now suffering
patients a route for potential cure? To criminalize therapeutic cloning
in this country poses serious ethical problems. Given that adult stem
cell research is still in its infancy and it cannot be predicted what
or when a therapeutic application will be delivered, can we afford to
wait until this field has matured? Do you want to tell patients who
suffer NOW of incurable and debilitating diseases that they will have
to wait for an unspecified number of years until the technical problems
of adult stem cells may have been resolved? In contrast, a patient with
the same disease in Britain may be able to use a stem cell based
therapy in a few years to come.
Unfortunately, the public discussion of therapeutic cloning suffers
from serious misconceptions. Often, ``reproductive cloning'' is not
differentiated from ``therapeutic cloning''. The word ``cloning''
provokes negative emotional reactions. I am concerned that the
revulsion against ``cloning'' rather than objective reasons may lead to
legislative actions that might impede potentially promising research. A
case in point is ``nuclear magnetic resonance imaging'' or ``NMRI''.
This technique, now known as ``MRI'', became widely used in the clinic
as diagnostic procedure only after the word ``nuclear'' was dropped
from its designation (because no radioactive substance is used). It
would be unfortunate indeed if legislative decisions would be based on
emotional rather than objective criteria.
I want to make a final point. In the 70s, when IVF became available
as a reproductive technology, federally funded research was not
permitted in this country in contrast to European countries. The result
was that IVF was practiced in the private sector and lacked proper
supervision. As a consequence, even today the activities of many
fertility clinics are unsupervised and lack public scrutiny. It would
be unfortunate if a similar mistake were made with therapeutic cloning.
I believe we should proceed with this research under tight regulation.
The work should be supported by Federal funding, peer reviewed and be
conducted in academic institutions of the highest standing that are
bound to follow scientific and ethical standards and are subject to
public scrutiny.
Senator Harkin. Dr. Jaenisch, thank you very much for your
statement.
Dr. Blackwelder is president of Friends of the Earth, a
national organization dedicated to preserving the environmental
health and diversity of the planet. Dr. Blackwelder received
his B.A. from Duke University, M.A. from Yale, and Ph.D. from
the University of Maryland. He is an advocate for expanding the
national wild and scenic systems. Dr. Blackwelder, welcome, and
please proceed.
STATEMENT OF DR. BRENT BLACKWELDER, PRESIDENT, FRIENDS
OF THE EARTH
Dr. Blackwelder. Thank you very much, Mr. Chairman. I might
mention that I have spent the past 30 years as an environmental
advocate working for a number of environmental organizations.
My doctorate from the University of Maryland is in the area of
philosophy. My specialty is ethics. I wrote my dissertation on
duties to animals, so I feel especially geared to give this
testimony for you today, because I want to lay out for you the
environmental case for banning reproductive cloning and putting
a moratorium on therapeutic cloning.
Basically, the case is that these actions violate two
fundamental cornerstone principles of the modern environmental
movement: respect for nature and the precautionary principle.
But at the outset, I want to point out that the debate is being
framed as one being between those who want to make tremendous
progress in alleviating human suffering, curing some of the
most terrible diseases humanity now faces, and those who want
to block medical progress, and I think that is the wrong way to
look at the momentous decisions that we are about to make,
because we are, in fact, dealing with decisions that will take
us in the direction, potentially, of commodifying all life on
earth.
We have already seen things going on now with genetic
engineering in agriculture, and now proposals with humans that
cross the species barriers and take us in the direction of a
totally manufactured world. What we want to also emphasize is
that not only are we dealing with two types of cloning,
reproductive and therapeutic cloning, but we are also dealing
with those who want to work on inheritable genetic
modifications, the so-called designer babies, a subject which
has, in fact, been discussed in Sports Illustrated as bringing
the end to athletics, if you can engineer super human beings.
I think this is a big cluster of issues, and therefore we
are urging, with the precautionary principle, that you actually
take a deep and hard look at some of the things going on.
So with that, let me just describe these two principles to
you. Environmental organizations embrace the idea of respect
for nature because we carry on many activities. Groups run
nature centers, conduct lots of education programs and so
forth, take people on nature outings. We strive to demonstrate
the interdependence of humans in the natural world, and the
value of each species' contribution to the entire ecosystem. If
a species is altered or wiped out, that can affect the entire
ecosystem.
We think the very act of cloning animals or people crosses
the threshold of respect for the individuality of the species,
and the features of the individuals within each species. That
principle leads us to oppose the full-scale commodification of
nature, whether it be humans, animals, plants, or landscapes.
Now, even though many in the biotechnology businesses
assert that their only goal is curing disease and saving human
lives, I want to assure you that there are many others out
there, published in the literature, and whom we have debated on
national television, that have a much broader agenda. They have
the designer baby syndrome and the cloning of human beings
fully on their intent. They have said so on national TV. You
may think you are banning one form of cloning and allowing the
other to go forward, but we very much want to point out that
the Feinstein-Kennedy bill, for example, does not provide
roadblocks in the way of crossing those barriers, and we attach
to our testimony a critique done by the International Center
for Technology Assessment, and I put in my testimony some of
the quotes from people who have written books like Remaking
Eden, that this is not theoretical concern that we have, it is
a real, genuine one, and it leads directly into the second
point I want to make, which is the precautionary principle.
The precautionary principle basically takes the wisdom of
the ages, the old adages, look before you leap, an ounce of
prevention is worth a pound of cure. We do not want to go
forward with actions that impose risks on others or on society
as a whole. We have got to know what we are doing. This is not
an antiscientific point of view. We are very progressive, we
think, at Friends of the Earth as an organization, but we take
a review of the past 100 years of fiascoes, with introduced
species, civil works projects, agricultural experiments,
medicine and disease, and we ask you in this testimony, don't
these exemplify worst-case scenarios materializing, whereas
individuals today are saying, well, we have got a best-case
scenario, we are going to really cure all these diseases.
We are saying, if you take a look at some of these examples
you will find a different story, and I might just point out
that the Office of Technology Assessment has indicated that the
cost of these invasive alien or exotic species which have been,
in some cases, deliberately introduced over the past 100 years,
costs the economy now $100 billion.
Just take a look. The Department of Agriculture introduced
the chestnut blight into the United States because they had a
subdivision that wanted to put new species in. They brought the
Asian chestnut in. Very quickly, the most valuable tree in the
Eastern United States for wildlife, and commercially, was wiped
out, and to this day there is no cure for that chestnut blight.
I mean, that was done with the best of all intentions, but look
at the horror and tragedy to the forests.
I point out, for example, that in the Great Lakes since
1829, there have been over 100 alien or invasive exotic species
put in. Two of those, like the beaver mussel and the lamprey
are with us today, causing tens of millions of dollars worth of
damage.
If you turn, for example, to genetically engineered crops,
Friends of the Earth was the one that had to point out that the
Starlink corn, the genetically engineered starlink corn, not
approved for human consumption, only for animals, got into our
food supply. Well, that surely shows the failure of a
regulatory regime, so you may hope that some of these
therapeutic clones do not go the other direction, but the track
record is not great.
Just another example, mad cow disease, vigorously denied by
British authorities as to have any jumping capability to
humans, and yet it did jump, and now they are sorry. Now we
have got a serious problem spread to Europe.
prepared statement
These ought to introduce into our thinking the idea that
the best-case scenario is not always the one we ought to
explore, and so in my testimony I try to lay that out for you,
and I just want to conclude--I see my time is up--by quoting
from the great environmental naturalist Aldo Leopold, who wrote
``The Sand County Almanac,'' and he said, ``the human role of
conqueror, where we are in this role, eventually is self-
defeating, because it is implicit in such a role that the
conqueror knows, ex cathedra, just what makes the community
clock tick, just what and who is valuable, and what and who is
worthless in community life. It always turns out that he knows
neither, and this is why his conquests eventually defeat
themselves.''
I am prepared to answer questions for you. Thank you very
much for the opportunity to testify.
[The statement follows:]
Prepared Statement of Dr. Brent Blackwelder
introduction
Friends of the Earth is a national conservation organization
dedicated to a cleaner, healthier planet for all life on earth. We are
part of Friends of the Earth International which has member groups in
69 countries. I have been President of Friends of the Earth since 1994.
My doctorate is in philosophy from the University of Maryland, with
ethics being my field of specialization.
The Senate is now considering long-overdue legislation to ban human
cloning. The debate is being framed as one between modern medical
science seeking new technologies for the prevention and treatment of
disease and those who are trying to block medical progress. The purpose
of the Friends of the Earth testimony is to present the environmental
case against both human cloning and the closely related issue of human
germline manipulation or inheritable genetic modifications (``designer
babies'').
At the outset I wish to note that Friends of the Earth acknowledges
that many applications of human genetic science, including those using
stem cells, hold great medical promise. However, the rapid pace of
development of new technologies, the enormous stakes involved, the lack
of societal controls to date, the failure to analyze environmental
implications, and the fact that informed public debate has barely
begun, all indicate the need for immediate legislative action to ban
the creation of full-term human clones (reproductive cloning) and at
least to place a moratorium on the creation of clonal human embryos for
research purposes (therapeutic cloning).
Friends of the Earth is strongly opposed to S.1758, introduced by
Senators Feinstein and Kennedy, and we offer a critique showing that
not only does this bill fail to control human cloning, but also that it
gives the green light to full-scale commodification of human life.
Environmental organizations are concerned with the accelerated
pollution and destruction of wetlands, forests, mountains, agricultural
lands, and wildlife which occurred during this past century. Today
humanity stands on the brink of a totally new and alarming change in
our earth, as well--a change which could carry us into an entirely new
realm of artificial existence and a new type of pollution--biological
pollution, more ominous possibly than chemical or nuclear pollution.
Science now has the capability of creating cloned beings and designer
babies and of crossing the species barriers which have for millennia
separated plants from animals and some groups of animals from other
animals. The real specter of a totally manufactured world is upon us.
The basic environmental case against cloning and engineering of the
human germline manipulations (designer babies) is that these actions
violate two cornerstone principles of the modern conservation movement:
respect for nature and the precautionary principle.
cloning and the principle of respect for nature
Environmental organizations embrace an ethic of respect for nature.
Environmental organizations carry on a variety of educational
activities to help people understand and appreciate the natural world.
Some take people on nature outings, others operate or support nature
centers. We strive to demonstrate the interdependence of humans and the
natural world and the value of each species' contribution to an entire
ecosystem. If a species is altered or wiped out, then changes to the
whole ecosystem can be expected.
The very act of cloning animals or people crosses the threshold of
respect for the individuality and remarkable features of each species
as well as the individuals within species. The principle of respect for
nature leads us oppose to the full-scale commodification of nature--
whether it be humans, animals, plants, or landscapes.
The push to redesign human beings, animals and plants to meet the
commercial goals of a limited number of individuals is fundamentally at
odds with the principle of respect for nature. Even though many in the
biotechnology business assert that their goal is only curing disease
and saving lives, the fact remains that once these cloning and germline
technologies are perfected, there are plenty who have publicly avowed
to utilize them. Friends of the Earth has even been called upon to
debate such people on national television.
Some proponents of human cloning and germline manipulations, for
example, extol the virtues of ``improving'' on the humans, animals, and
plants now in the world by re-engineering them. Here is what they are
saying:
Lee Silver, molecular biologist at Princeton University, in his
book Remaking Eden: How Cloning and Beyond will Change the Human
Family, envisions a future in which the appearance, cognitive ability,
sensory capacity, and life span of our children will become artifacts
of genetic manipulation: ``The GenRich--who account for 10 percent of
the American population--all carry synthetic genes. All aspects of the
economy, the media, the entertainment industry, and the knowledge
industry are controlled by members of the Gen Rich class-- Naturals
work as low-paid service providers or as laborers--the GenRich class
and the Natural class will become entirely separate species with no
ability to cross-breed, and with as much romantic interest in each
other as a current human would have for a chimpanzee.''
James Watson, Nobel laureate and co-discoverer of the structure of
DNA: ``if we could make better human beings by knowing how to add
genes, why shouldn't we? What's wrong with it? Evolution can be just
damn cruel, and to say that we've got a perfect genome and there's some
sanctity to it? I'd just like to know where that idea comes from. It's
utter silliness.''
Lester Thurow, noted MIT economist: ``biotechnology is inevitably
leading to a world in which plants, animals and human beings are going
to be partly man-made. . . . Suppose parents could add 30 points to
their children's IQ. Wouldn't you want to do it? And if you don't, your
child will be the stupidest child in the neighborhood.''
The proposed and ongoing genetic engineering today is radically
different from the thousands of years of agriculture where crops and
animals have been transformed through cross breeding of very similar
species. Experiments in genetic engineering violate the natural species
barrier. We have witnessed scientists inserting fish genes in tomatoes
and strawberries, making goats which produce spider-like webs in their
milk, and adding human genes to pigs.
The cloners like Watson and Silver want to engineer nature to suit
their objectives and don't recognize any duties to animals and people
who could be redesigned to match the scientists' own vision. There is
no reverence or awe of nature but simply a desire to replace plants and
animals with the scientists' selection of traits--all for the purpose
of making money.
The Feinstein-Kennedy bill (S. 1758) facilitates the objectives of
those just quoted because it would allow a completely unregulated
commercial industry in human cloning to produce embryos that could be
brought to term illegally under a reproductive ban.
To turn next to the practical experience with animal cloning, it is
important to note that Ian Wilmot, the developer of the cloned sheep
Dolly admits that almost all clones suffer serious abnormalities. The
recent finding of premature arthritis in Dolly is one of the strongest
indicators to date that there should be, at a minimum, a moratorium on
human cloning and on commercial animal production through cloning. What
parent wants to risk a child that will be diseased, deformed or
developmentally disabled after a few years? Who wants to eat food that
may be harmful?
Recent polling shows that 90 percent of Americans do not want human
cloning. One of the reasons is that no one should be the subject of an
experiment without their consent. Any cloned child would be such an
experiment. What Americans do want are therapeutic technologies that do
not carry such risks. The New Scientist has just reported that a stem
cell which can turn into every single tissue in the body has just been
found in adults. The article goes on to say: ``If so, there would be no
need to resort to therapeutic cloning--Nor would you have to
genetically engineer embryonic stem cells to create a one cell fits
all' line that does not trigger immune rejection.'' (January 23, 2002
``Ultimate stem cell discovered'' New Scientist)
cloning violates the precautionary principle
The precautionary principle is another pillar of the modern
environmental movement. The basic idea of the precautionary principle
is that before imposing significant risks on others or society as a
whole, we should have a solid grasp of what is being proposed. The
principle embodies the wisdom of ancient adages such as ``look before
you leap'' and ``an ounce of prevention is worth a pound of cure''.
Thus the precautionary principle mandates that when there is a risk
of significant health or environmental damage to others or to future
generations, and when there is scientific uncertainty as to the nature
of that damage or the likelihood of the risk, then decisions should be
made so as to prevent such activities from being conducted unless and
until scientific evidence shows that the damage will not occur.
A review of major environmental problems of the 20th century
reveals a range of unanticipated and awful economic and environmental
consequences as a result both of individual actions and various modern
technologies. Had the precautionary principle been operative, many of
these disastrous consequences might have been avoided. Here are a few
examples in the areas of chemicals, civil works projects like dams,
introduced exotic species, agriculture, disease and medicine where the
precautionary principle was not applied.
The numerous cases of alien, foreign, exotic, or invasive species,
which have beset North American ecosystems like a plague in the past
hundred years, makes vividly clear the problem of unanticipated
consequences. The Federal government estimated that the annual economic
costs of invasive species is over $100 billion. (U.S. Office of
Technology Assessment, 1993)
Some introductions of alien species have been deliberate. The
starling was brought to America by a man who believed that our country
should have all the birds mentioned by Shakespeare. Now starlings are
one of the most dominant birds, crowding out native song birds. One of
America's most important trees, both from a wildlife and a commercial
standpoint, was the chestnut. Very swiftly a disease, introduced
through a USDA program, wiped out all the great chestnut trees. No cure
has to this date been found. Other invasives like gypsy moths, the
Asian long-horned beetle, and Dutch elm disease still plague our
forests.
The zebra mussel, which was probably carried in the ballast water
of a Black Sea tanker, has proliferated throughout the Great Lakes
region and now causes tens of millions of dollars of damage as it clogs
up water pipes. A century ago the predatory eel called the lamprey got
into the Great Lakes via the Erie and Welland Canals and devastated
fisheries and persist to this very day.
The moral of this story is that the ecosystem disruption caused by
invasive species not only devastates native flora and fauna but can be
enormously costly. Another lesson is that biological pollution
proliferates and reproduces and is not easily stopped if it can be
stopped at all.
The precautionary principle was not applied when our society began
using very dangerous chemicals in the aftermath of World War II. To
this very day we have major and costly battles about cleaning up
nuclear and toxic waste produced many years ago. A prime example
recently in the news is the battle between EPA and General Electric
over the chemical PCB waste which still remains in the Hudson River
decades after the PCBs were dumped by the company.
Looking at civil works projects, our society did not think through
the devastating effect of dams on Atlantic and Pacific salmon and on
other fisheries until many decades after precipitous declines in
fisheries had occurred. Now dramatic efforts are being made to try to
restore some of the salmon runs.
In the area of genetically engineered food, Friends of the Earth
exposed the presence in our food supply of genetically engineered
Starlink corn, which had been approved for consumption only by animals,
not humans. Starlink corn began showing up on grocery shelves all over
the country. Despite being planted on only 0.5 percent of the corn
field acreage, it contaminated 10 percent of the entire crop in the
year 2000.
A decade ago in the case of mad cow disease, the public witnessed
the vigorous denial by British officials of any connections between
feeding regimes (cows being forced to eat cows) and the disease, and
asserted that the disease could not jump from cows to humans. Now they
have acknowledged their errors, but the disease has spread to Europe.
In other medical news about recent knee surgeries where people have
died, the January 20, 2002 New York Times headline reads: ``Lack of
Oversight in Tissue Donation Raising Concerns--Tight Rules on the Use
of Organs Do Not Apply to Tissues''. When the subject goes from tissue
and organ donations to the deliberate insertion of inheritable traits,
the precautionary principle reminds us that it is not just the patient
but future generations who are going to be impacted. One cannot simply
recall a bad judgment on inherited traits. That is the lesson of
biological pollution presented above.
The great naturalist Aldo Leopold observed that the human role of
conqueror is ``eventually self-defeating because it is implicit in such
a role that the conqueror knows, ex cathedra, just what makes the
community clock tick, and just what and who is valuable, and what and
who is worthless, in community life. It always turns out that he knows
neither, and this is why his conquests eventually defeat themselves.''
(A Sand County Almanac)
Many scientists and companies in biotechnology are prone to present
only the best case scenario. The Friends of the Earth recitation of
fiascoes from the past 100 years of biological invasions as well as
recent screw-ups in modern medicine show that our society must focus on
more than simply best-case scenarios. The precautionary principle poses
a direct challenge to uninhibited experimentation on people and the
planet--experimentation done in the name of progress, but often driven
by the desire to make money. The Feinstein-Kennedy bill does not
embrace the precautionary principle but flaunts it.
Senator Harkin. Thank you very much, Dr. Blackwelder, for
your statement, and now we turn to Dr. Maria Michejda, a senior
staff associate at the International Center for
Interdisciplinary Studies of Immunology at Georgetown
University. Dr. Michejda received her M.D. from the Medical
Academy in Gdansk, Poland, and is an expert in fetal tissue
transplantation and fetal tissue banks.
Dr. Michejda, please proceed with your statement.
STATEMENT OF DR. MARIA MICHEJDA, SENIOR RESEARCH
ADVISOR, IMMUNOLOGY CENTER, GEORGETOWN
UNIVERSITY MEDICAL CENTER
Dr. Michejda. Mr. Chairman, honorable Senators, ladies and
gentlemen, it is an honor and privilege to present my views on
an aspect of the incredibly important issue that you are
considering. My name is Maria Michejda. I am a physician
involved in research on fetal tissue transplantation. My
credentials are in the written testimony.
For over 20 years, my research has focused on the fetal
tissue transplantation and on the biology of stem cells from
various sources. We initiated the first studies on fetal tissue
from second trimester spontaneous abortions over 10 years ago.
We found that the stem cells were superior in terms of the
biological properties for transplantation, long-term
engraftment, and cell reconstitution. Today, I would like to
present some of the biological problems of stem cells in the
various flavors to you, and to suggest that some of these
problems may have disastrous consequences in terms of human
therapy. I would like especially to focus on stem cells derived
from both reproductive and therapeutic cloning.
Therapeutic cloning is achieved by asexual reproduction
methods which involve the so-called somatic cell nuclear
transfer, or as we have now, nuclear transplantation. If the
transfer is successful, the oocytes containing the implanted
genomic material will undergo several divisions to produce a
pre-implantation embryo known as the blastocyst, which, after
destruction will produce new embryonic cell lines.
In reproductive cloning, on the other hand, the blastocyst
is placed in the uterus and may develop into a baby. This has
not been accomplished in humans, but many animal examples are
known. Both therapeutic and reproductive cloning have the very
serious problem of gene imprinting, since all the genetic
material comes from one somatic cell. The consequences of gene
imprinting are profound, and affect the very process of
cloning, as well as the product of the cloning.
Simply put, the product can be defective. It is now well-
appreciated that the nuclear transfer process is highly
insufficient, and would be very costly and impractical for
therapeutic purposes. Moreover, most clones die before birth
during animal reproductive cloning and many survivors display
various abnormalities. These include placental and fetal
overgrowth, immunological impairment, expressed by autoimmune
disease such as the early arthritis diagnosed in the famous
Dolly, and accelerated aging.
The consequences of gene imprinting in humans are
potentially devastating. Animals may be more tolerant to any
genetic aberrations which may initially reside only in the
subtle abnormalities. Such abnormalities cannot be ignored in
human material, particularly the embryonic cells derived from
embryonic cloning and used for transplantation, which would
result in the transfer of genetic abnormalities to the
recipient. Such aberrations may not be evident at the early
stage, but would become expressed at later age. Consequently,
cloning technique to acquire stem cells for transplantation are
impractical, costly, and may lead to serious medical problems.
Besides major medical problems associated with cloning, one
should also take into account the possible legal consequences
of professional responsibility and malpractice when something
goes wrong.
Finally, there is a limited supply of oocytes suitable for
nuclear transfer. This will result in the model and medical
pressure of women of reproductive age. Harvesting of human eggs
is not free of dangerous infections, hemorrhage, malignancy,
and infertility, which will particularly affect women in
financial need.
The initial euphoria associated with the promise of
therapeutic cloning has now been tempered by the realization of
the multiple problems. This has become evident in the research
community, and it is beginning to be expressed into the popular
press. While I fully agree with the National Academy of Science
panel that more research is needed in the area of stem cells, I
would like to point out that the problems associated with human
cloning are profound, and cannot be ignored. In fact, this
could retard progress in the development of cell therapies,
which are in large measure one the most exciting developments
in medicine.
A prohibition of human cloning will not inhibit stem cell
research. It will focus attention on proven sources of stem
cells such as fetal cord blood, adult cells, and expand the
curative potential in scope.
Here, I would like to reemphasize that pluripotent fetal
stem cells derived from second trimester spontaneous abortions
exhibit proven, highly prophylactic engraftment and curative
potential that were made evident in transplantations many years
ago. Fetal stem cells have most of the properties of embryonic
stem cells, but do not exhibit the uncontrolled replication
that is a characteristic of embryonic cells which lead to
teratomas, malignancies, and chromosome abnormalities upon
transplantation.
prepared statement
In conclusion, technologies for safe and efficient cloning
do not exist. Our obligation on the one hand is to protect
human life and the safety of patients and, on the other, to
prevent dissemination of erroneous information about curative
potentials of unproven sources of stem cells for human
therapies.
Thank you.
[The statement follows:]
Prepared Statement Maria Michejda
Honorable Senators, Ladies and Gentlemen: It is an honor and a
privilege to present my views on an aspect of the incredibly important
issue that you are considering. My name is Maria Michejda. I am a
physician and I have been and continue to be very active in research in
the general area of fetal medicine. I am the founder of the Journal of
Fetal Diagnosis and Therapy, the principal journal in the rapidly
growing field of fetal medicine, and a co-founder of the International
Fetal Medicine and Surgery Society. I served as an advisor on fetal
issues in a number of academic and non-academic institutions, including
the German and Dutch parliaments. Currently, I am an Associate
Professor of Radiology and Nuclear Medicine at NYU and a Senior Staff
Associate at the Immunology Center of Georgetown University. For over
20 years my main research focus was on fetal tissue transplantation and
subsequently on the biology of stem cells derived from various sources,
including fetal bone marrow obtained from spontaneous miscarriages,
adult bone marrow, cord blood and peripheral blood. We have, in fact,
initiated the first studies on fetal tissues from 2nd trimester
spontaneous abortions over 10 years ago. As a consequence, we have
developed considerable expertise in the acquisition, processing and
application of this underutilized and non-controversial source of stem
cells (1-8).
My initial studies on fetal tissue transplantation for the in utero
treatment of congenital malformations focused on allogeneic
transplantation of bone, bone marrow and neural tissue. This work,
which was initiated at NIH and subsequently carried out at Georgetown,
utilized non-human primates as models resulted in novel techniques for
the treatment of neural tube defects in babies before birth. These
studies also led to the appreciation of the unique properties of fetal
tissue, including cellular regeneration, self-repair, a high rate of
cellular proliferation and differentiation, followed by rapid
vascularization of the new tissue (6,7). We have focused our attention
over the last ten years on the exploitation of the remarkable
properties of fetal tissues in general and fetal stem cells in
particular (3,4,8).
We have recently conducted extensive comparative studies on
properties of stem cells derived from various sources. We examined stem
cells derived from adult bone marrow, umbilical cord blood, adult
peripheral blood and fetal bone marrow. The fetal bone marrow was, as I
said earlier, obtained from 2nd trimester spontaneous miscarriages.
Without going into extensive detail, we found that the fetal stem cells
were superior in terms of their biological properties for
transplantation, long-term engraftment and cellular reconstitution. One
of the most important and beneficial characteristics of fetal stem
cells derived from the bone marrow is that they are pluripotent and can
differentiate into many lineages. They are also highly immature and
immuno-incompetent. This means that they are not rejected by the host,
in contrast to adult stem cells, and do not induce graft versus host
disease. Also, unlike the other sources of stem cells, the fetal stem
cells do not require matching of the donor and the recipient (7,9).
Today, I would like to present some of the biological problems of
stem cells in their various flavors to you and to suggest that some of
these problems may have disastrous consequences in terms of therapy. I
would like especially to focus on stem cells derived from both
reproductive and therapeutic cloning. Therapeutic cloning is achieved
by asexual reproduction methods, which involve the so-called somatic
cell nuclear transfer. This is accomplished by microinjection of the
nucleus from a human donor cell that carries a complete set of
chromosomes into a human ovum from which the nucleus has been removed.
If the transfer is successful the oocyte containing the implanted
genomic material will undergo several divisions to produce a
preimplantation embryo known as the blastocyst. After five days, this
entity is composed of 100-150 embryonic cells. It is then destroyed in
order to create new embryonic cell lines in culture. In reproductive
cloning on the other hand, the blastocyst is placed in the uterus and
may develop into a baby. This has not been accomplished in humans but
many animal examples are known (10-12).
Both therapeutic and reproductive cloning have the very serious
problem of gene imprinting since all the genetic material comes from
one somatic cell. The consequences of gene imprinting are profound and
affect the very process of cloning as well as the product of the
cloning (10,11). Simply put, the product can be defective. It is now
well appreciated that the nuclear transfer process is highly
inefficient and would be prohibitively costly and impractical for
therapeutic purposes. Moreover, most clones die before birth during
animal reproductive cloning and many survivors display various
abnormalities. These include placental and fetal overgrowth,
immunologic impairments, expressed by autoimmune diseases (such as the
early arthritis diagnosed in the famous Dolly), and accelerated aging.
The consequences of gene imprinting in humans are potentially
devastating. Animals may be more tolerant to epigenetic aberrations,
which may initially result in only subtle abnormalities. Such
abnormalities cannot be ignored in human materials, particularly in
embryonic cells derived from therapeutic cloning and used for
transplantation, which could result in the transfer of the
abnormalities to the recipient, the experiments in mice
notwithstanding. Such aberrations may not be evident at early stages
but would become expressed at a later age. Consequently, cloning
techniques to acquire stem cells for transplantation are impractical,
costly and may lead to serious medical problems.
Besides the major ethical and medical problems associated with
cloning, one should also take into account the possible legal
consequences of professional responsibility and malpractice when
something goes wrong. Finally, there is a limited supply of oocytes
suitable for nuclear transfer. This will result in moral and medical
pressures on women of reproductive age. Harvesting of human eggs is not
free of dangers of infection, hemorrhage, malignancy and infertility,
which will particularly affect women in financial need.
The initial euphoria associated with the promise of therapeutic
cloning has now been tempered by the realization of the multiple
problems. This has become evident in the research community and is
beginning to be expressed in the popular press (see New York Times,
Dec. 18, 2001). While I fully agree with the National Academy of
Sciences panel that more research is needed in the area of stem cells,
I would like to point out that the problems associated with human
cloning are profound and cannot be ignored. In fact, this could retard
progress in the development of cellular therapies, which are in large
measure one of the most exciting developments in medicine. A
prohibition of human cloning will not inhibit stem cell research, but
will focus attention on proven sources of stem cells such as fetal,
cord blood, and adult cells and expand their curative scope. Here, I
would like to re-emphasize that pluripotent fetal stem cells derived
from 2nd trimester spontaneous abortions exhibit proven highly
proliferative engraftment and curative potentials that were made
evident in transplantations many years ago (13-24). Fetal stem cells
have most of the properties of embryonic stem cells but do not exhibit
the uncontrolled replication that is a characteristic of the embryonic
cells, which leads to teratomas, malignancies and chromosomal mosaicism
upon transplantation.
In conclusion, technologies for safe and efficient cloning do not
exist. Our obligation on one hand is to protect human life and the
safety of patients, and on the other to prevent the dissemination of
erroneous information about curative potentials of unproven sources of
stem cells for human therapies.
references cited
1. Thorne ED, Michejda M: Fetal tissue from spontaneous abortions:
A new alternative for transplantation research. Fetal Diagnosis and
Therapy,1989, 4:37-42.
2. Michejda, M., Peters, SM, Bellanti JA: Xenotransplantation and
Stem Cell Reconstitution. Transplantation. 1992, 54:759-762.
3. Michejda M., Verma UN, Mazunider, M., Wu AG: Comparative study
of hemopoietic precursors from fetal and adult bone marrow. Fetal
Diagnosis and Therapy, 1996, 11(6): 52-61.
4. Wu, AG, Michejda, M., Mazunder, M. et al.: Analysis and
characterization of hematopoietic progenitor cells from fetal bone
marrow, adult bone marrow, peripheral blood and cord blood, Pediat.
Res. 1999, 46:163-169
5. Michejda M, Bacher J: Functional and anatomic recovery in the
monkey brain following excision of fetal encephalocele. Ped.
Neuroscience. 1986, 12:90-95.
6. Michejda M: Antenatal treatment of central nervous system
defects: Concept and future developments in experimental therapies.
1990, Fetal Diagnosis and Therapy S1:1-23.
7. Michejda M: CNS Repair in ``Unborn Patient'' 2nd edition,
Harrison M, Golbus M, Filly R., eds. (Grune and Stratton, Inc., San
Francisco, New York,). Chapter 9. 1988, pp.565-580.
8. Michejda, M.: Quo Vadis Fetal Tissue Transplantation? J.Hemato.
Therap.
9. Lindvall, O, Widner H, Rehncrona S: Transplantation of fetal
dopamine neurons in Parkinson's Disease: One-year clinical and
neurophysiological observations two patients with putaminal implants.
Ann Neurol 1992;31:155-165.
10. Eggan K., Akutsu H., Loring J. et al.: Hybrid vigor, fetal
overgrowth, and viability of mice derived by nuclear cloning and
tetraploid embryo complementation. Proc. Nat. Acad. Sci., USA, 2001, 98
(11): 6209-14.
11. Humpherys D., Eggan K., Akutsu H. et al: Epigenetic instability
in ES cells and cloned mice. Science 2001. 293: 95-97
12. Antoniou, M. The case against . . commentary. Nature Medicine,
2001, 7: 397-399.
13. Touraine JL, Roncarolo MG, Touraine F: Fetal tissue
transplantation, bone marrow transplantation. Thymus 1987, 10:75-81.
14. Touraine JL, Royo C, Roncarolo MG: Unmatched stem cell
transplantation as a possible alternative to bone marrow
transplantation. Transplant Proc 1989, 21:3112-3113.
15. Touraine JL, Raudrant D, Royo C: In utero transplantation of
hemopoietic stem cells in humans. Transplant Proc 1991, 23:1706-1708.
16. Touraine JL: In utero transplantation of fetal liver stem cells
in Humans. Blood Cells 1991, 17:379-387.
17. Touraine J.L.: Transplantation of fetal liver stem cells in to
patients and into human fetuses with induction of immunologic
tolerance. Transplant. Proc. 1993: 25:1012-13.
18. Eastlund T, Low WC and Mooradian DL: Isolation and culture of
osteoblast progenitors from human fetal calvarium. Transplant. Proc.
1994, 26:3400-3402.
19. Tocci A, Menichella G, Perreta G, Pirerelli L, Noja G. and
Mancuso S: Fetal tissue collection from spontaneous abortions: a report
from a single Centre. Fetal Diagri Ther. 1994, 9:204-8.
20. Low WC, Eastlund T, Verfaille C: Human fetal tissue from
spontaneous abortions as potential sources of donor tissue for cell
transplantation therapies. Transplant. Proc. 1994, 261:1-6.
21. Edwards, R.G., ``Fetal tissue transplants in medicine'' in
Edwards, R.G. (ed.): Fetal Tissue. Cambridge University Press,
Cambridge, 1992, chapters 11 and 12.
22. Michejda, M.Utilization of fetal tissue in transplantation.
Fetal Ther, 1998, 21:129.
23. ``Fetal Liver transplantation'' Lucarelli, G., Fliedner, P.M.,
Gale, R.P.(eds) Exerpta Medica, Elsevier North-Holland, New York, N.Y.,
1980.
24. ``Fetal Liver transplantation'' Gale, R.P., Touraine, J.P.,
Lucarelli. G (eds) Alan Liss, New York, N.Y., 1985.
Senator Harkin. Dr. Michejda, thank you very much.
My personal thanks to all of the panel for being here today
and for all of the work that you have done in the past in
focusing on this issue. It is one that is contentious. We all
know that, and there are views on different sides. Some of the
views are different based on medicine approaches, some of the
views that differ are based upon ethical considerations, some
of the views differ based on fundamental religious beliefs.
So you have a confluence here not just on the medical
differences, but ethical and religious differences on this
approach, and as you might expect, the Congress of the United
States is now being asked to step in--not being asked, I guess
Congressmen and Senators are stepping into this fray, as well
as the administrative end of the Government, the executive
branch. Again, I am not a scientist. I have no expertise in
this area. I study, I read as much as I can comprehend, but we
are trying to figure a way to try to thread this needle, so to
speak, on where we can keep the research moving ahead, but to
do it in a manner that, while it may not satisfy every person's
ethical problems, will at least answer the majority of them.
I mean, there are people with certain beliefs, deeply held,
which I respect, that are opposed to many of the things we have
as commonplace today in medicine, and after all, there are
members of the Christian Science religion who do not believe in
any kind of medical procedures. I respect that. That is their
belief, but again we have to move ahead and try to figure out
what we can do in the framework of a free and open society,
paying attention to being cognizant of and respectful of these
ethical differences and religious differences.
Now, when it comes to cloning questions, as I said before,
it seems like everyone here, it seems to me, agrees that human
cloning should be banned. Now, I use my chart here. I point to
it again. I used it last fall. I do not think it has changed
since then. We have got two courses here. Correct me if
anything is wrong on this chart, but you take DNA from a sick
patient, you take a donated egg, you take out the DNA of the
egg, you put in the DNA of the sick patient, then you have two
courses of ways you can go. You can go to implantation, to have
a cloned human, or you can go down this way on cellular
transfer and develop the blastocyst and the stem cells, and
then the stem cells later on to cure the patient.
There are some who want to ban this procedure. The bill
that Senator Specter and I introduced today puts the ban on
human cloning. It would permit cellular transfer but not
implantation, and the bill we introduced has both civil
penalties and criminal penalties for engaging in that activity.
Is that, Dr. Weissman, sort of what your bioethics panel
suggested?
Dr. Weissman. First, we are not a bioethics panel. We are
the scientific panel.
Senator Harkin. You are right, you did not get into ethics.
Dr. Weissman. You are absolutely correct, and I think it is
really important that our recommendation said that there be a
legally enforceable ban for human reproductive cloning. That
would end any speculation that somebody, some mad scientist in
the lab would take the incipient stem cells in their earliest
stages that one wants to study to use to make stem cell lines
and put them in a uterus. There is a legally enforceable ban
that you put in to protect against that possibility, and I
think that is sufficient. You do not need to go further than
say, if you try to practice reproductive cloning with these
cells, or in the attempt to make a blastocyst to make these
cells, you will be subject to a legally enforceable ban.
Senator Harkin. Well, here is the dividing line. Dr.
Blackwelder, what is wrong with that approach?
Dr. Blackwelder. Well, the basic point is that you may try
to put it there, but the problem is that we have seen all too
often things do not work.
For example, the anthrax, it was reported in the paper from
Fort Dietrich, disappeared, something that should have been
off-limits. It got loose. So what happens with the rogue
scientists and so forth, they get free, and we move forward in
this direction.
I do not know what your bill is going to say, but the
Feinstein-Kennedy bill did not tighten the loopholes in this
regard, and the critique we have provided demonstrates a number
of ways in which there is not even a review body on it, so I
cannot comment on what your bill is going to do, but that bill
is too much like a Swiss cheese, and once you start down that
direction, you see, with this going, where do you draw the
line?
The question we raise also, isn't there enough that can be
done on the promise of stem cells--just in my testimony I
quoted the article from the New Scientist yesterday. They found
a cell in adults that may turn into every single tissue in the
body. This might essentially preempt the whole debate if this
is true. A lot of checking has to be done.
That is why we suggest that a moratorium on this, so we do
not risk the down side but allow the medical promise to be
explored. We are just at the early stages. Why do we have to go
the very risky route, and a route that the attempt by some of
your colleagues in their bill would surely not foreclose.
Senator Harkin. Well, there is a difference between our
bill and Kennedy's bill. I do not need to go into that right
now. We put in criminal penalties as well as civil, plus ours
is the total ban. I think that is where we differ from you. You
wanted a 5-year to look at it. We just banned it outright, so
there are some differences there.
But this question, well, they found a new cell that may--I
do not know all about that, but I will ask Dr. Weissman to
comment on that.
Dr. Weissman. Sir, one thing that is important that
everyone understand about science is that in our spirit of free
inquiry we do experiments, and we publish experiments, and they
are published in peer review journals, meaning people try to
look at it to make sure they are correct, but it is not far
enough to do an experiment that looks correct from one point of
view at that time by one group. You have to have independently
reproduced experiments.
The article in the New Scientist--I have not read it, but I
know what it is about--does not come from a paper that is
published in a peer review journal, much less independently
verified. It would be great if what is in the New Scientist
turns out to be true. It does not affect the issues at all that
we are trying to get at.
We have to understand that nuclear transplantation to
create stem cells allows us for the first time to try to
understand not only how to transplant stem cells and to
transplant cells, therapeutic cloning, which I think everybody
is focused on, but much more importantly, opens up an area of
research we have not been able to pursue, and I will give you a
perfectly clear example, I hope.
Many of us, probably everybody in this room, carries genes
that give you a risk to inherit a particular disease, whether
it is cardiovascular disease, heart attack, stroke, cancer
development, Lou Gehrig's disease, Parkinson's disease,
whatever, so those are genetic factors that make a risk, but
not everybody with those genetic factors get that disease.
But in those people who get the disease, they have got the
genetic factors combined in them in a way we still do not
understand, but it leads to the disease, so if we can take the
nucleus of a cell from that patient, or even more importantly
the nucleus of the diseased cell from that patient and create a
cell line that we can study in test tubes, in the mature cells,
in mouse models, it opens up an incredible avenue of research.
It is so general and so pervasive that it will affect all of
the kinds of research that we do as biomedical scientists.
And I will remind you that this kind of a debate went on
about 20 years ago when a number of groups thought putting
together two pieces of DNA, so called recombinant DNA, was
creating life, but we now have many drugs, erythropoietin, the
interferons, growth hormones, GCSF and so on, which are actual
and real, practical therapies. Hundreds of thousands of lives,
conservatively, are saved or made better every year in the
United States.
Had we banned that research because of a precautionary
principle those lives would not exist today, and we would not
have a biotechnology industry which helps us move forward.
Senator Harkin. Dr. Weissman, my time is up. I will get to
my second round. I will turn to Senator Specter.
Senator Specter. Thank you, Mr. Chairman.
Dr. Michejda, I have great respect for the work which you
have done in fetal tissue, and the moral issues relating to
these subjects, and if the embryos could produce life, I
believe that is what we ought to use the embryos for, every
last one of them, to the extent that they can produce life.
In the bill which Senator Harkin and I worked on this year,
we took a start with $1 million on a fund to promote adoptions,
and People Magazine has a very interesting article in the
January 24 issue on Last Chance Family on adoptions, and we are
now working on tax credits to encourage adoptions, but there is
no doubt that however many adoptions there may be, that there
will be embryos left over. In vitro fertilization creates more
than are needed, even with a mammoth program on adoption, so
the moral question comes up, if these embryos can be used for
stem cells to save lives, isn't that a morally acceptable use,
contrasted with throwing them away?
Dr. Michejda. Your Honor, I think it is here what we
discuss is not the moral aspect but medical aspect and
feasibility of that technology to apply in future cellular
therapies, and that is what that important medicine, that is
the future of medicine, practically.
Obviously, the sources are very important, and safety of
these sources in transplantation for the patients, for the
transmission of possible----
Senator Specter. When you talk about safety, I want to talk
about that in a minute, but just on the strict moral issue, if
the embryo is going to be thrown away, is it immoral to use it
to save lives? If the embryo can create a life, I agree it is
immoral not to do that, but if the embryo is going to be thrown
away, is it immoral to use it?
Dr. Michejda. You ask me for moral and ethical questions,
and I am here as a physician to answer the medical problems
associated with the cloning. I would like to stress again that
both, at least in my opinion, reproductive and therapeutic
cloning has to be done at initially the same fashion, the same
way, and carries the same problems and consequences as far as
the transfer of some disastrous diseases, or immunological
deficiencies, yes.
Now, if we are talking about the problems of embryo, or
cells which are existing, and I have to say that what I know
from colleagues in the IV centers, the number of cells, stored
cells, is very small, and decreasing, simply because technology
improved.
Finally, this technology was taken from animal husbandry.
Now it is improving.
Senator Specter. Pardon me, I have a very limited amount of
time. Let me ask one question on your statement about
abnormalities.
Dr. Michejda. Yes.
Senator Specter. I notice that your line of expertise is on
fetal tissue. Can you document abnormalities resulting from
nuclear transplantation? Do you know of actual cases where
there have been abnormalities?
Dr. Michejda. It was never done in humans, but there is
literature on animals about problems associated with this
technology, so it exists.
Senator Specter. Do you have examples on abnormalities from
animals, on nuclear transplantation?
Dr. Michejda. Yes. There is overgrowth, there is a
significant skeletal malformation, there is accelerated aging,
and the last reports on the famous Dolly, which has arthritis.
Obviously, there is a certain--the problem of autoimmune
diseases is very real in such a situation, when you have one
cell donor and recipient, actually.
Senator Specter. Dr. Michejda, to the extent you can
provide the subcommittee with specifics on abnormalities, we
would appreciate it. I had asked you the question on morality
because your resume, your curriculum vitae, expressed that
aspect of your work, but I respect your answer there.
Dr. Michejda. The references regarding animal experiments
are listed and will be on the record.
Senator Specter. Okay. Thank you very much.
Dr. Blackwelder, I agree with a great deal of what you have
said. We have had a terrible problem in Lake Erie with beaver
mussels, and I ought to take a look at that chestnut blight on
our Agriculture Subcommittee on Appropriations, and I certainly
would not want to commodify all types of life on earth, but
that does not point yet to the issue of nuclear
transplantation. We are not going to create a designer baby or
a commodity. We are going to take a woman, for example, who has
Parkinson's and we are going to have a procedure where her DNA
is going to be part of the production of the stem cell to save
her life.
Now, isn't that something where you draw that kind of a
line, which we are prepared to do very forcefully in the
legislation, and put up a wall, like Jefferson's wall, a
separation of church and State. Is that not something which is
acceptable?
Dr. Blackwelder. See, you are outlining a best-case
scenario. You are doing something, and whatever changes are
done, the patient may improve or may not, but it does not
affect others or society as a whole.
What we are saying is that we are on the edge of something
even much bigger than that, because you go right from the issue
of cloning to inheritable traits, designer babies and so forth,
and the questions have to be asked, are any things being done
here that are actually going to lead to the insertion of genes
that are passed on, because once you start passing things on,
you cannot blow the whistle and say, oops, we have made a
mistake.
This is a form of biological pollution. It is unlike
chemical pollution, or nuclear radioactive pollution. Those
decay and wane over time, but we have seen with the examples
that I cited, you have got things out there replicating and so
forth. That is why we are saying, incredible oversight needs to
be provided here. We need to know more clearly what is going
on.
The Feinstein bill did not do it. The Feinstein bill did
not even provide any regulatory scheme about women possibly
selling their eggs, the patenting of the cloning embryos and
everything else that could sort of set up these kind of
workshop mentality. What is actually going to go on here is a
big issue, and it is beyond the kind of case that you just
outlined. I am just trying to draw out for the committee the
larger, overarching issues that need very extensive discussion.
Senator Specter. Oh, I understand your testimony. You are
saying the case I outlined is acceptable so long as it does not
lead to reproductive cloning.
Dr. Blackwelder. Well, for example, if you are using a
discarded embryo, okay, and stem cells from that, or adult stem
cells, or stem cells, if this article I cited, it turns out
that works, Friends of the Earth does not have a problem with
that, okay, but if you are starting out with the same kind of
situation where you are going to, under certain scenarios of
screw-ups and so forth, move forward and inadvertently, or
clandestinely, or criminally things happen--for example, under
the Feinstein bill, what is to stop some people from taking
those--you are right at your middle stage, and you go over to a
foreign entity, and they start the cloning process.
Senator Specter. My time is up, so I am going to on the
second round ask Dr. Jaenisch and Dr. Weissman questions, but I
am going to suggest to Senator Feinstein that she call you when
she has her hearing, because you have done more testifying
about the Feinstein bill than anything else, and I am very
interested in that, but not as interested as she is.
Dr. Blackwelder. Well, I just hope you will not--I mean
that I hope your legislation is not going to repeat some of the
defects.
Senator Specter. You have practically convinced me to vote
against the Feinstein bill and I do not know anything about it.
But I would terminate with your point that if we stop
there, your testimony was it is okay with Friends of the Earth.
Well, I am a friend of the earth myself, and we are going to
stop right there. We are not going to take that step beyond.
I would like to come back on round two with you, Mr.
Chairman.
Senator Harkin. Thank you. I think Dr. Jaenisch wants to
respond.
Dr. Jaenisch. Yes. I would like to respond to some
scientific issues which were raised by Dr. Michejda about the
concern that problems could arise in using cloned embryonic
stem cells, and imprinting was mentioned as being one of the
problems.
Now, my laboratory is working with imprinting for the last
15 years, so let me clarify these issues because I think there
is some confusion here.
I think it is right, the most serious abnormalities in
cloned animals are called by what we call faulty reprogramming,
or it is a faulty expression of these imprinted genes which are
important for the development of the whole embryo.
In contrast, when an embryonic stem cell is differentiated
into muscle cells, nerve cells, cells of the pancreas, then
these functional cells are derived without going through an
embryonic stage. There is no embryo, there is no heart
development, so these streams are not important. So to
summarize, the faithful expression of an imprinted gene is
crucial for embryonic development, but has probably little
function for the adult cell.
Of course, in cloning, and I think that is what she was
referring to, in cloning you ask one nucleus to give rise to
every tissue of the animal, including going through all
development. This is a big problem. In embryonic stem cells
there is no embryo made, so these genes are not called into
action. They are not important.
So let me just emphasize, I think, the very important
difference here. In cloning, the donor nucleus must direct
development of the whole embryo, with all organs, and there are
a serious abnormalities we see in every cloned animal, as I
have stated. This is not the case in tissue--so then we have
found that embryonic stem cells themselves are unstable, which
raises concerns there might be problems in transplantation.
Now, there is extensive experience from the last 20 years
with mouse embryonic stem cells. There is not a single case
where transplantation of an embryonic stem cell derivative into
a mouse has caused any abnormalities. There is not a single
case, because--I should say transplantation of embryonic stem
cells in a developing embryo to form a so-called chimeric
mouse, which is a mouse which is composed of cells which come
from a fertilized embryo and from the stem cell, in this case
there is no abnormality.
Senator Harkin. Let me make sure I understand what you have
just said. In however many--you say 20 years, or 15 years of
doing this research--that if you take a stem cell--are we
talking about embryonic stem cells?
Dr. Jaenisch. Embryonic stem cells.
Senator Harkin. An embryonic stem cell, and you place it in
an egg whose DNA has been removed and let that develop into the
embryonic stage, that there are abnormalities in almost every
case.
Dr. Jaenisch. If you ask this nucleus to develop into an
animal.
Senator Harkin. That is what I am talking about.
Dr. Jaenisch. Yes.
Senator Harkin. If it goes beyond the embryonic stage.
Dr. Jaenisch. Yes.
Senator Harkin. If, however, you take those cells at the
blastocyst stage and remove those stem cells, and let those
stem cells develop and multiply, and then take those stem cells
and implant them in a mouse, for example, that you say there is
no case, not one, in which it has expressed itself as some
abnormality.
Dr. Jaenisch. That is correct. This is a very stringent
experiment, because in this case you put the stem cell into the
early developing embryo, so it is has to contribute to all
tissues.
Senator Harkin. Yes.
Dr. Jaenisch. But the presence of the normal cells, the
normal cells being from the fertilized embryo, from the host
embryo, totally then corrects the problems the stem cell would
do if it was alone.
Senator Harkin. Let me ask this question. In these
experiments, are those stem cells, the stem cells that were
later placed in the animal, in the mouse, were those embryonic
stem cells derived from that same mouse, or from other mice?
Dr. Jaenisch. Can be from another mouse, from any mouse.
Senator Harkin. From any mouse?
Dr. Jaenisch. They can be also derived from a cloned
embryo. It has been shown, even if they were derived from a
cloned embryo, the so-called chimeric mouse which develops is
totally normal, so the problems we see in cloning do not apply
to stem cells which give rise to differentiated cells in
culture, because the genes we know, which are very important
for----
Senator Harkin. But tell me, in your own words again, tell
me why it is that if you take the stem cells and let them
develop into the embryonic stage and beyond, that there are
abnormalities, but if you take those stem cells in the
blastocyst stage and remove them, and let them multiply on
their own as stem cells, why are there not any abnormalities
there? I do not understand. Is there any reason?
Dr. Jaenisch. Yes, I think there is a logic behind this.
The logic is that when you take embryonic stem cells and
culture them in the Petri dish, and derive, let us say, nerve
cells, then you do not have to go to embryonic development, so
the genes which are a problem do not have to be correctly
expressed. They are not needed, and these genes which have to
be correctly expressed to make an animal are not important for
the function of the nerve cell or the beta cell once it has
been derived. You can derive this in culture.
So when you take those cells and transplant them into a
patient, for example, or into a mouse, they function perfectly
well. It does not matter that the expression of the genes is
not correct, the ones that are needed for the very early stages
of development, because you do not need early stages of
development for this type of approach, so there is a basic
difference here.
Senator Harkin. We both have to call this to an end, but I
just want to ask one question of all the panelists. I will
start with Dr. Michejda.
Dr. Michejda, do you support in vitro fertilization?
Dr. Michejda. As what, as a technology?
Senator Harkin. No, I mean people right now, infertile
couples right now sometimes will go to in vitro fertilization
and then take that and implant that in the woman's womb, and
then it develops into a baby. We have been doing that for years
now. I just wondered, are you supportive of that, or not?
Dr. Michejda. There are several types of in vitro
fertilization, and there is one form where the surrogacy is not
used. In other words, this is between the couple, the exchange
of semen and ovum, so I think that is acceptable. If we go to
some surrogacy and get from different donors, not partners and
so on, we have a lot of legal problems and ethical, so I would
be definitely against this.
Senator Harkin. But if you had a woman and a man who wanted
to have a child, but for some reason were incapable, but the
woman produced eggs and you could remove the egg and take the
sperm from the man, and combine those in a Petri dish and then
take that and plant that in the womb for the reproduction of a
child, you say that is okay.
Dr. Michejda. Well, as long as it is within family.
Senator Harkin. Well, now you are getting into moral and
ethical issues. I am just talking about medical issues.
Dr. Michejda. No, legal, mostly legal, because there were
many problems.
Senator Harkin. But you say that is okay.
Dr. Michejda. I would say yes.
Senator Harkin. How about you, Dr. Blackwelder?
Dr. Blackwelder. We have not taken a position on that, but
I want to reemphasize in my testimony that we are not only
opposed to reproductive cloning, we want a moratorium on the
therapeutic cloning.
Senator Harkin. You want to stop it all?
Dr. Blackwelder. A moratorium for 5 years. We are not
opposed to stem cells. We say stem cells have a lot of promise,
but there may be other ways to get them, other things to check
out.
Senator Harkin. So you are opposed to embryonic stem cells.
Dr. Blackwelder. Yes.
Senator Harkin. You are okay with adult stem cells. You are
okay with that.
Dr. Blackwelder. Yes. Yes, or if an embryo is discarded, if
an embryo is discarded, going to be thrown away, then that does
not raise all the problems that we have tried to lay out,
whereas if you turn women into egg factories, the
commodification or patenting of life, and the other issues
relating to inheritable genetic traits.
So if you understand, I want to be very clear I have laid
it out, we should place that moratorium on what we call the
therapeutic cloning for 5 years.
Senator Specter. With respect to the moratorium, Dr.
Weissman, let me thank you for the work which your panel has
done, the telephone conversation which you and I had back in
August and your work generally. Dr. Burt Vogelstein from Johns
Hopkins has given us a list of the potential of stem cells, and
this goes to the heart of the issue of a moratorium, whether we
ought to be doing the work here, notwithstanding the fact that
if we stop nuclear transplants the work will go all around the
world, where the research is being undertaken.
Dr. Vogelstein produced this list for the utility of stem
cells: cardiovascular disease, 58 million; autoimmune disease,
30 million; diabetes, 16 million; osteoporosis, 10 million;
cancers, 8,200,000; Alzheimer's, 5,500,000; Parkinson's
5,500,000; spinal cord injuries, 250,000; birth defects,
150,000, with a conservative estimate that there would be a
saving of 1,700,000 lives each year, on the potential for stem
cell research and the nuclear transplants, and that is why I
categorized it as a life and death matter. I would like your
evaluation as to the importance of stem cell research and
nuclear transplants in terms of saving 1,700,000 a year, going
to the issue of moratorium and the sense of urgency which I
believe we need here.
Dr. Weissman. Sure, so the first point is that anybody who
would enact a moratorium closes the window of possibility of
therapy for those people who have the disease, so there is no
middle ground here. If you have a ban or a moratorium on that
kind of research, you are really in the situation that you are
going to prevent therapies from development.
Now, science is unpredictable, so we cannot say the exact
time at which all of these valuable things will come out. I can
just say that this is as fundamental as recombinant DNA, and
unpredictably that led to great therapies, and very rapidly
under the guidance and the control of the Recombinant Advisory
Committee.
There is no doubt that we want, as a community, to have the
usual kinds of safeguards of human subject research and tissues
from humans going through institutional research boards and
other boards like a national panel, but I agree with you
entirely that the medical potential for this is broad, because
it really affects almost every disease that has at least a
genetic component to it, or where tissues degenerate that are
important, like in Parkinson's or Lou Gehrig's disease.
Senator Specter. Thank you very much. This has been a very
excellent panel, Mr. Chairman. I thank you all for your
contribution. Thank you.
Senator Harkin. Thank you, Senator Specter.
I, in closing, just want to note Dr. Weissman's comments
about the drugs that have been developed and the lives saved
because we did not close the door on recombinant DNA research.
I think my environmental record is pretty good in terms of
where Friends of the Earth are situated and things like that,
but again, we all want to be precautionary. We all want to
proceed with caution.
Shutting a door is not precautionary. It is opening the
door, but doing it very carefully, doing it under guidelines,
doing it under the strictest of peer review, and yes, ethical
guidelines, to be sure, but to open it carefully, not just to
slam it open, but to open it carefully, to look behind that
door and see what is there. That is precaution. That is
precaution.
To say somehow that we should have a ban, I say to my
friend Brent Blackwelder, or to put a moratorium on it--go out
and talk to people with Parkinson's disease and tell them they
have got to wait some more. You go talk to my nephew, who has
been quadriplegic for 20 years with a spinal cord injury, who
keeps up on this daily. He knows exactly what is going on out
there, and he knows what has been happening in rats in terms of
spinal cord rehabilitation through stem cells. Tell him to wait
because you have a little bit of concern here, there has got to
be a moratorium. You know, the old Native American adage, you
know, walk a mile in the moccasins.
There are a lot of people out there with suffering that can
be alleviated. We do not know when. We do not know if any of it
is going to work, but to shut the door on it, and to say we are
going to have a moratorium I think is just--I am sorry, that is
where I depart. Precaution, yes. Open the door carefully, yes.
Have a care and concern for moral and ethical considerations,
yes, and try to find some way of moving ahead under those kinds
of guidelines, and that is what this committee and what others
here are trying to do.
I fully recognize there are the extremes. There are those
that say, there should not be any controls. There are those
that want to clone human beings right now. There are some
crazies out there right now that want to clone human beings.
They want to be the first to do it.
And there are those on the other side that do not want
anything. There are some out there opposed to all
biotechnology. Nothing, stop it all.
Somewhere between, we have got to chart a course.
Dr. Blackwelder. Yes, well, why not exhaust the adult stem
cell possibilities first?
Senator Harkin. Well, I answer you this way. Basic
research, I have often said, is like--you have got 10 doors out
there. We are going back to the door analogy. Basic research is
saying, what is behind those doors?
Well, if you open one of the 10 doors, chances are you may
not find the answer. If you open half of the doors, you have
got a better chance of finding the answer. If you open 9 of the
10 doors, you have got a really good chance at finding the
answer. I do not want to stop adult stem cell research. Let it
go forward, but do not stop embryonic stem cell research,
because we do not really know right now which is going to have
the most promise, so that is all I am saying. Keep them both
going, but do it under these guidelines.
Dr. Michejda, I am going to let you have the last word
here, and then I am going to close.
Dr. Michejda. Thank you very much. Two problems. First of
all, we are talking about therapies, which means a lot of
cells, a lot of embryonic cells from cloning or from in vitro
fertilization. The fact is, which I tried to explain with
Senator Specter, that we do not have unlimited sources of
cells.
Senator Harkin. We do not have unlimited----
Dr. Michejda. Unlimited sources of cells for cloning or
whatever, and at this point the whole burden really is on the
reproductive system of women.
Senator Harkin. But wait, we do have nearly an unlimited
source because we have thousands of embryos that are now frozen
in nitrogen left over from in vitro fertilization that are
going to be destroyed.
Dr. Michejda. There are not so many, Senator. I mean, a
thousand.
Senator Harkin. There are several hundred that I know of
anyway.
Dr. Michejda. Well, but that is not therapy. That is not
enough.
Senator Harkin. But every scientist I have ever talked to
said that within that universe out there of leftover embryos
from in vitro fertilization, there is more than ample supply of
stem cell lines.
Dr. Michejda. We are talking here about approval or
rejection of cloning, as such, as the source of cells for
therapies for the future, therapies in this country or in the
world. I want to say again, the sources are limited for that
massive therapies in the future. For research, obviously,
probably not, and not all of the cell lines are good, and we
know about it.
So anyway, we have to face some crisis somewhere, and this
will depend upon the reproductive system of women, and
stimulation, and getting more cells. I am looking more beyond
today. I am thinking about the future.
Now, also, as far as the gene imprinting in animals is
concerned, there are many reports of abnormalities. In fact, in
Germany, the ban of cloning was based on the facts which were
observed in the log-ins, and the reports were in Science, and I
am serving as advisor to the German parliament on fetal issues,
and I am more or less informed that that is the situation.
Senator Harkin. I have just been told that there are over
100,000 frozen embryos in England alone, 100,000, and I would
submit that with that kind of universe out there, the cell
lines that you would need are more than adequate for the kind
of research that needs to be done.
Dr. Michejda. Research, yes, but not therapy.
Senator Harkin. I need to close this up, with respect to--
--
Dr. Weissman. I am not going to go to that issue. I just
wanted to correct something you said, or I do not think I was
clear enough in saying to you. The National Academy's
recommendation did not say the ban should just last 5 years. It
said the scientific and medical issues should be relooked at
within 5 years, because we need to give Congress bioethics
panel an update on what we know.
Senator Harkin. Fair enough. Fair enough.
Well, it has been a very good panel, and obviously you are
all very bright and capable and very learned individuals, and
again we invite you to continue to give us the benefit of your
thoughts and your advice as we move ahead in this area. We have
a job to do, and we are going to have to do it.
SUBCOMMITTEE RECESS
Thank you all very much for being here, that concludes our
hearing.
[Whereupon, at 12:25 p.m., Thursday, January 24, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
CLONING, 2002
----------
TUESDAY, MARCH 12, 2002
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 2:04 p.m., in room SD-192, Dirksen
Senate Office Building, Hon. Arlen Specter, presiding.
Present: Senator Specter.
PROHIBITING HUMAN REPRODUCTIVE CLONING AND SAVING MEDICAL RESEARCH
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. The Subcommittee on Labor, Health and
Human Services and Education will now proceed.
We regret the shift on the schedule, but after this hearing
was set, President Bush announced his intention to travel to
Philadelphia this morning, and when the President comes to
Philadelphia, that is a command performance for those of us who
represent Pennsylvania. We thank the staff for rearranging the
schedule, and we thank all the witnesses for rearranging their
schedules to accommodate this change in timing.
The chairman of the subcommittee, Senator Harkin, is very
heavily engaged in the agriculture bill, so he is going to be
unable to join us. But he has been a leader on the issue of NIH
funding and stem cells and nuclear transplantation, which some
call therapeutic cloning as a misnomer.
We are very appreciative to have with us a former Senator,
Connie Mack, who was the original sponsor of the resolution to
double the NIH funding over a 5-year period. That has been the
rallying call for an increase in funding for NIH, some $12
billion a few budget periods ago to now $23 billion.
At the outset, when we set on the course, this subcommittee
took the initiative in asking the Budget Committee for $1
billion, and we were turned down. So, we went to the floor, had
a vote, lost 63 to 37, but found the billion dollars as a
matter of priorities in other matters.
And then having been turned down on $1 billion, we asked
the next year for $2 billion, which is the way appropriations
work. We were again turned down, but found the money on
reassessing priorities. On the last vote, it was 96 to 4 in
favor of increased funding for NIH.
This year the President has asked for $3.7 billion more for
the National Institutes of Health, which is a tribute to
President Bush, and to his administration. It shows how popular
the program has become and how much public acceptance it has
had.
In November 1998, stem cells burst upon the scene, and this
subcommittee promptly scheduled a hearing and has now had 12
hearings on the subject. We have found, as many of you, if not
all of you, an ideological divide. The embryos which produce
the stem cells also produce life, but many of them are
discarded. Up to 2 dozen are created for in vitro fertilization
and approximately 6 or 8 are discarded. Many of us think that
rather than throw them away, they ought to be used to save
lives.
The subcommittee put $1 million in the 2002 budget to
stimulate adoption of embryos. If they could all be adopted,
that would be wonderful, then we would not have any left over
for stem cells. But that will never happen because there are
tens of thousands of them which will not be used. And we are
currently considering legislation for a tax credit, up to
$5,000 for people who adopt an embryo for a child born through
that process.
We are now involved in another controversy over so-called
therapeutic cloning, which is not cloning at all. There is a
consensus not to make another individual, not to make another
Arlen Specter, for example. If we could make another Kevin
Kline, it might be another matter. But the so-called
therapeutic cloning, as I say, is not cloning. What it involves
for example, is taking a cell from somebody who has
Parkinson's, taking an egg, removing the DNA, putting that cell
in the egg, and then the stem cells, which are produced, are
not rejected.
We are about to have a Senate debate on the subject in the
next several weeks, and there is a real need for public
understanding and a public debate if we are to win that vote.
This is very critical.
We have Congressman Bart Stupak scheduled to testify, who
has a different view than Senator Connie Mack. Senator Mack's
testimony we believe is especially important because he has a
strong pro-life record, as do other Senators, and in that
context, Senator Hatch, who has been a strong proponent of stem
cells, has not yet taken a position on nuclear transplants.
Senator Gordon Smith has taken a position in favor of stem
cells and nuclear transplants, and we have many Senators who
have come over to our side in suppporting stem cell research.
Some 64 signed letters last spring and 12 more favored a
broader Federal role on Federal funding on stem cells. And then
the President made his announcement on August 9 permitting
Federal funding for stem cell lines in existence at that time.
It is an issue which has been put on the back burner after 9/
11. But the so-called therapeutic cloning issue is very much
before us now.
So, with that introduction, I am delighted to turn to my
distinguished colleague, Senator Mack. Senator Mack served in
the House of Representatives, and in the U.S. Senate for two
terms. And we have conducted this introduction long enough to
allow Congressman Stupak to arrive to hear the beginning of
Senator Mack's testimony. Connie, the floor is yours.
STATEMENT OF HON. CONNIE MACK, FORMER U.S. SENATOR FROM
FLORIDA
Senator Mack. Thank you, Senator Specter. I am particularly
pleased to be back before the subcommittee. As you know, I
served on this committee a few years ago. I am delighted to be
with you.
Actually before I begin my testimony on the subject of
today's hearing, let me commend and thank you, Senator Harkin,
and the other members of the committee for the bipartisan
effort to achieve the goal of double funding of the National
Institutes of Health. With your continued leadership, this
historic effort will be completed in the fiscal year 2003. I am
convinced that we will continue to see significant advances in
science and medicine for many generations to come as a direct
result of the basic clinical research that has been conducted
during this 5-year period.
This marks the first time since I retired from the Senate
that I have testified before my former colleagues. But I feel
so strongly about the policy that the Congress of the United
States might actually criminalize important biomedical research
that I have to speak out, and I appreciate the opportunity to
do so.
As you may be aware, one of my main areas of interest and
where my passion truly lies is biomedical research. Today I am
involved with several biomedical research entities precisely so
I can help make a difference in advancing this important
effort.
The U.S. Senate will soon act on legislation already passed
by the House of Representatives that would ban an important
area of medical research that holds great promise for millions
of patients who suffer from medical conditions such as heart
disease, spinal cord injury, and diabetes. The legislation
would criminalize the research and prohibit any therapies from
entering our country that were produced as a result of this
research, even if the therapies are proven to be safe and
effective.
The idea that Congress would make criminals of researchers
pursuing cures for diseases that kill and debilitate our loved
ones is almost unimaginable. But if the Senate passes this
controversial legislation, that is exactly what will happen.
What is this research? As you know and as you indicated
earlier, it is called somatic cell nuclear transfer, or SCNT,
research. SCNT is the ability to derive a patient's own stem
cells, which are the building blocks of human development, and
use those stem cells to repair the patient's damaged cells or
tissues.
The research is sometimes referred to as cloning, but all
cloning is not the same. One type, which most believe should be
stopped, is the cloning of humans. It is called reproductive
cloning. But there is another type called therapeutic cloning
which could be used to replace damaged cells and tissues. SCNT
research is an example of therapeutic cloning and is the type
of research that some want to criminalize.
Let me be clear. Like most Americans, I oppose human
reproductive cloning. It is dangerous and raises far too many
moral, ethical, and legal issues and could have enormous social
implications. That is not what this debate should be about.
It is important to make the clear distinction between
reproductive and therapeutic cloning. For therapeutic purposes,
scientists use a technique that I mentioned a moment ago called
somatic cell nuclear transfer, or SCNT.
How does it work? First, the nucleus of an egg cell is
removed. In its place, researchers insert the nucleus of an
already differentiated cell, a cell that performs a specific
function in the body. Chemicals are added to stimulate the egg
to start dividing. This egg cell is never fertilized by sperm
and will never be implanted into a womb. Therefore, I do not
believe it should be called an embryo or that it is in fact
human life.
At about 3 to 5 days, a blastocyst is formed which contains
an inner cell mass comprised of a very small number of non-
programmed cells, something so small it cannot be seen by the
naked eye. The research value of these cells, however, is
enormous. They have the potential to form any cell in the body
and can reproduce indefinitely. Studies in animals demonstrate
that this could lead to cures and treatment for millions of
Americans.
As exciting as that is, it is only part of the story. When
combined with stem cell research, SCNT could be used to develop
new and innovative treatments that allow cells, tissues, and
organs to function again.
Let me explain. When cells, including donated organs,
tissue, or blood, are transplanted or transfused, the
recipient's body mounts a rejection response, attacking these
cells as foreign. However, if a patient's own somatic cells
were the source of stem cells used to create therapeutic cells
or tissues, immunological rejection could be avoided since the
cells and the tissues would exactly match those of the person
who donated the somatic cell nucleus. Therefore, SCNT could
allow a patient's own cells to be used to treat or cure that
patient's disease.
Although some believe that stem cell research could proceed
without SCNT, the overwhelming majority of scientists believe
that SCNT is essential to turn the research into cures and
treatments that actually help patients. For example, both the
National Institutes of Health and the National Academy of
Sciences have recently released reports that stress the
importance of this specific type of research. Scientists are
joined by a wide range of patient advocacy groups for which
this research is a matter of life and death.
Unfortunately, this is precisely the research that would be
banned by H.R. 2505 that passed the House and the pending
proposal sponsored by Senator Sam Brownback. Senator Brownback
is a good friend and I certainly do not question his motivation
for sponsoring this legislation. As one who is also pro-life, I
too have struggled with this issue. I am concerned, however,
about the impact this bill will have on the future of the
biomedical research.
In addition to shutting the door on important research,
these bills will limit patient access to potentially life-
saving products. And according to the legislation, if a drug or
treatment for a disease is developed overseas in a country that
allows the use of cloning for research purposes, it will not be
available to patients in the United States, even if the FDA
finds that it is safe and effective. Thus, Americans would be
denied access in this country to cures and treatments, while
citizens of other nations receive the benefits of these
products.
Fear and misunderstanding about biomedical research is not
new. In the mid-1970's, for example, recombinant DNA research
was at a similar crossroad. We can all recall the fear by some
that mad scientists were going to create a Frankenstein
monster. Some in Congress called for banning recombinant DNA
research. And they were wrong.
Fortunately, Congress did not ban the research. The
research continued and millions patients and their families
have benefitted. Today, recombinant DNA research is used to
produce human therapeutics to treat a wide variety of diseases
and conditions. These products include human insulin for
diabetes, Herceptin for breast cancer, Epogin for patients with
kidney disease, Pulmozyme that has prevented death in children
with cystic fibrosis, and Cerezyme for Gaucher's disease.
Yet, nearly 30 years later, the Senate is poised to debate
legislation that could permanently shut off a different but
equally important and promising area of biomedical research.
This simply must not happen.
The United States has long been the world's leader in
medical research. This research has benefitted our citizens who
have access to the best medical care and newest treatments. It
has also been good for our economy, as it has created hundreds
of thousands of high-paying jobs.
Tougher restrictions targeted at reproductive cloning are
necessary, but shutting down SCNT, even for a short time, runs
counter to our history and tradition. More importantly, it will
deny Americans access to the best medical treatments.
Senator Specter, as you know, I have lived the terrible
ordeal of watching a loved one confront a disease without a
cure. Therapeutic cloning, SCNT, is controversial, but it
raises new hopes that must be explored. And I urge the Senate
not to deny hope to millions of families coping with deadly
diseases by criminalizing this vital research.
Thank you, Senator Specter.
[The statement follows:]
Prepared Statement of Former Senator Connie Mack
Mr. Chairman, Senator Specter, and Members of the Subcommittee, it
is a pleasure to appear before this subcommittee, on which I had the
great honor of serving.
Before I begin my testimony on the subject of today's hearing, let
me commend and thank the Members of this subcommittee for your
bipartisan effort to achieve the goal to double funding for the
National Institutes of Health. With your continued leadership, this
historic effort will be completed in fiscal year 2003. I am convinced
that we will continue to see significant advances in science and
medicine for many generations to come as a direct result of the basic
and clinical research that has been conducted during this five-year
period.
This marks the first time since I retired from the United States
Senate that I have testified before my former colleagues. But I feel so
strongly about the possibility that the Congress of the United States
might actually criminalize important biomedical research that I have to
speak out. As you may be aware, one of my main areas of interest, and
where my passion truly lies, is biomedical research. Today, I am
involved with several biomedical research entities, precisely so I can
help make a difference in advancing this important effort.
The United States Senate will soon act on legislation already
passed by the House of Representatives that would ban an important area
of medical research that holds great promise for millions of patients
who suffer from medical conditions such as heart disease, spinal cord
injuries and diabetes. The legislation would criminalize the research
and prohibit any therapies from entering our country that were produced
as a result of this research, even if the therapies are proven to be
safe and effective.
The idea that Congress would make criminals of researchers pursuing
cures for diseases that kill and debilitate our loved ones is almost
unimaginable. But if the Senate passes this controversial legislation,
that is exactly what will happen.
What is this research? As you know, it's called somatic cell
nuclear transfer (SCNT) research. SCNT is the ability to derive a
patient's own stem cells, which are the building blocks of human
development, and use those stem cells to repair the patient's damaged
cells or tissues.
This research is sometimes referred to as cloning. But all cloning
is not the same. One type which most believe should be stopped is the
cloning of humans. It is called reproductive cloning. But there is
another type, called therapeutic cloning, which could be used to
replace damaged cells and tissues. SCNT research is an example of
therapeutic cloning, and it is this type of research that some want to
criminalize.
Let me be clear: like most Americans, I oppose human reproductive
cloning. It is dangerous and raises far too many moral ethical and
legal issues and could have enormous social implications. That's not
what this debate should be about.
It is important to make the clear distinction between reproductive
and therapeutic cloning. For therapeutic purposes, scientists use a
technique they call somatic cell nuclear transfer or ``SCNT''.
Here's how it works: First, the nucleus of an egg cell is removed.
In its place, researchers insert the nucleus of an already
differentiated cell (a cell that performs a specific function in the
body). Chemicals are added to stimulate the egg to start dividing. This
egg cell is never fertilized by sperm, and will never be implanted into
a womb. Therefore, I do not believe should be called an embryo, or that
it is human life.
At about 3-5 days, a blastocyst is formed which contains an inner
cell mass comprised of a very small number of non-programmed stem
cells, something so small it cannot be seen by the naked eye. The
research value of these cells is enormous. They have the potential to
form any cell in the body and can reproduce indefinitely. Studies in
animals demonstrate that this could lead to cures and treatments for
millions of Americans.
As exciting as that is--it's only a part of the story. When
combined with stem cell research, SCNT could be used to develop new and
innovative treatments that allow cells, tissue, and organs to function
again.
Let me explain: When cells, including donated organs, tissues or
blood, are transplanted or transfused, the recipient's body mounts a
rejection response, attacking these cells as foreign. However, if a
patient's own somatic cells were the source of stem cells used to
create therapeutic cells or tissues, immunological rejection could be
avoided since the cells and tissues would exactly match those of the
person who donated the somatic cell nucleus. Therefore, SCNT could
allow a patient's own cells to be used to treat or cure that patient's
disease.
Although some believe stem cell research could proceed without
SCNT, the overwhelming majority of scientists believe SCNT is essential
to turn that research into cures and treatments that actually help
patients. For example, both the National Institutes of Health and the
National Academy of Sciences have recently released reports that stress
the importance of this specific type of research. Scientists are joined
by a wide range of patients advocacy groups, for whom this research is
a matter of life and death.
Unfortunately, this is precisely the research that would be banned
by H.R. 2505 that passed the House and the pending proposal sponsored
by Senator Brownback. Senator Brownback is a friend, and I certainly do
not question his motivation for sponsoring this legislation. As one who
is also pro-life I, too, have struggled with this issue. I am
concerned, however, about the impact this bill will have on the future
of biomedical research.
In addition to shutting the door on important research, those bills
will limit patient access to potentially life-saving products.
According to the legislation, if a drug or treatment for a disease is
developed overseas in a country that allows use of cloning for research
purposes, it will not be available to patients in the United States--
even if the FDA finds that it is safe and effective. Thus, Americans
would be denied access in this country to cures and treatments, while
citizens of other nations receive the benefits of these products.
Fear and misunderstanding about biomedical research is not new. In
the mid-1970's, for example, recombinant DNA research was at a similar
crossroad. We can all recall the fear by some that mad scientists were
going to create a Frankenstein's monster. Some in Congress called for
banning recombinant DNA research. They were wrong.
Fortunately, Congress did not ban that research. The research
continued, and millions of patients and their families have benefited.
Today, recombinant DNA research is used to produce human therapeutics
to treat a wide variety of disease and conditions. These products
include human insulin for diabetes; Cerezyme for Gaucher disease,
Herceptin for breast cancer; Epogin for patients with kidney disease
and Pulmozyme that has prevented deaths in children with cystic
fibrosis.
Yet, nearly 30 years later, the Senate is poised to debate
legislation that could permanently shut off a different, but equally
promising, area of biomedical research. This simply must not happen.
The United States has long been the world's leader in medical
research. This research has benefited our citizens who have access to
the best medical care and newest treatments. It has also been good for
our economy, as it has created hundreds of thousands of high-paying
jobs.
Tougher restrictions targeted at reproductive cloning are
necessary. But shutting down SCNT--even for a short time--runs counter
to our history and tradition. More importantly, it will deny Americans
access to the best medical treatments.
I've lived the terrible ordeal of watching a loved one confront a
disease without a cure. Therapeutic cloning, SCNT, is controversial,
but it raises new hopes that must be explored. I urge the Senate not to
deny hope to millions of families coping with deadly diseases by
criminalizing this vital research.
Senator Specter. Thank you very much, Senator Mack, for
that testimony. Senator Harkin asked me, in taking the
assignment to Chair this hearing, to give you his special
personal thanks because we know you have come from Florida, and
he wanted to express his special appreciation to you.
Senator Mack. Thank you.
Senator Specter. We now turn to Congressman Bart Stupak,
elected to the House of Representatives in 1993, and before
that he served in the Michigan State House of Representatives
and has a background in the law, receiving his law degree from
Thomas Cooley Law School, after his bachelor's degree from
Saginaw Valley State College. And he also has had a career in
law enforcement as a State trooper with the Michigan Department
of State Police.
Congressman Stupak joins us today to present the other view
because the subcommittee is committed to hearing both sides and
giving all sides an opportunity to be heard.
Congressman Stupak, thank you for joining us, and we look
forward to your testimony.
STATEMENT OF HON. BART STUPAK, U.S. REPRESENTATIVE FROM
MICHIGAN
Mr. Stupak. Thank you, Mr. Chairman, and thank you for
holding this hearing.
I am here today to speak in strong support of Senate bill
1899, Senator Brownback's counterpart to H.R. 2505, the Weldon-
Stupak Human Cloning Prohibition Act of 2001.
On July 31, the House approved our legislation banning the
cloning of human embryos. It passed the House by a vote of 265
to 162. 265 Members of the House voted to ban the cloning of
human embryos. 265. This is not a number that can be explained
by arguments such as ``all the pro-lifers voted for it'' or
``those who oppose embryonic stem cell research voted for it.''
Many more voted for it after they looked at other legislation.
We are in the midst of a tremendous new debate, of a new
policy direction during a medical revolution. We cannot afford
to treat the issue of human embryo cloning lightly whether for
research or reproduction, nor can we treat it without serious
debate and deliberation.
The need for action is clear. Researchers have publicly
announced their intention to begin human cloning for profit.
Research firms have cloned human embryos for research purposes
here in the United States and in China. Whatever your belief is
about embryonic stem cell research, the fact is embryos are
biologically human entities.
We must ask ourselves what is the message we wish to send
on behalf of the American people?
Before we decide what this message is, we must answer these
questions. What makes up human beings? What is the human
spirit? What moves us? What separates us from animals? These
questions are the center of this debate.
What will the message of the U.S. Congress be? Will it be a
cynical signal that human embryo cloning and destruction is
okay, acceptable, even to be encouraged, all in the name of
science? Or will our message be one of urging caution and care?
If we allow this research to go forward unchecked, what will be
next? Unchecked research. Does it mean that once embryo cloning
is considered safe, we will then allow parents to choose what
color hair or eyes their baby will have? Would we allow
scientists to manufacture children with greater intelligence in
the pursuit of the perfect human being?
We need to consider all aspects of cloning and not just
what researchers tell us is beneficial.
Opposition to our legislation has based their objections on
arguments that it will stifle research, discourage free
thinking, and put science back in the dark ages. This is simply
ridiculous. Our bill does nothing of the sort. It allows animal
cloning. It allows tissue cloning. It allows current stem cell
research done on existing, normal embryos. It allows DNA
cloning. How is this stifling medical or scientific research?
These scientists who are pushing so hard to be allowed a
free pass for research on what constitutes the very essence of
what it is to be a human do not know what goes wrong with
cloned animal embryos. The horror stories are too many to
mention here, deformed mice and deformed sheep developing from
cloned embryos.
A prominent researcher working for the bioresearch
companies has admitted scientists do not know how or what
happens in cloned embryos resulting in these deformities. In
fact, he calls the procedure when the egg reprograms DNA magic.
Magic. This is hardly a comforting, hard-hitting scientific
term, but it is accurate. It is magic.
Opponents of our bill have said therapeutic cloning is the
Holy Grail of science which holds the key to untold medical
wonders. To our opponents, I would say show us these miracles.
Show me the wondrous advances done on animal embryonic cloning.
But these opponents cannot demonstrate these advances because
they do not exist.
Our ability to delve into the mystery of life grows
exponentially. All fields of science fuse together to enhance
our ability to go where we have never gone before. The question
is this: simply because we can do something, does that mean we
should?
What is the better path to take? One in which we mass
produce cloned embryos in the lab, a path which will lead to
producing cloned babies? Or is the better path one urging
caution, stepping forward based on sound science guided by
ethical, moral, and legal principles?
The human race is not open for experimentation and
manufacture at any level, even at the embryonic level, is
uncalled for. Has the 20th century not shown us the folly of
this thought?
Holy Grail? Magic? How about the human soul? Scientists and
medical researchers cannot find it, and most importantly, they
cannot medically explain it. Still, writers write about it.
Songwriters sing of it. You and I believe in it. From the depth
of our souls, we know that we should ban human cloning.
Mr. Chairman, thank you for the opportunity to be here. If
you have any questions, I will be happy to try to answer them.
[The statement follows:]
Prepared Statement of Congressman Bart Stupak
Mr. Chairman and distinguished members of this panel, I am here to
speak in strong support of S. 1899, Senator Brownback's counterpart to
H.R. 2505, the Weldon-Stupak Human Cloning Prohibition Act of 2001.
On July 31, the House approved our legislation, the Weldon-Stupak
Human Cloning Prohibition Act of 2001, banning the cloning of human
embryos. It passed by a vote of 265-162. 265 members of the U.S. House
voted to ban the cloning of human embryos. 265! This is not a number
that can be explained by unthinking arguments such as ``all the pro-
lifers voted for it,'' or ``those who oppose embryo stem cell research
voted for it.''
We are in the midst of a tremendous new debate; of a new policy
direction during a medical revolution. We cannot afford to treat the
issue of human embryo cloning lightly whether for research or
reproduction, nor can we treat it without serious debate and
deliberation.
The need for action is clear. Researchers have publicly announced
its intention to begin human cloning for profit. Research firms have
cloned human embryos for research purposes here in the United States
and China. Whatever your belief is about embryonic stem cell research
the fact is embryos are biologically, human entities.
We must ask ourselves what is the message we wish to send on behalf
of the American people?
Before we decide what is this message, we must answer these
questions.
What makes up human beings? What is the human spirit? What moves
us? What separates us from animals?
These questions are the center of the debate.
What message will the United States Congress send? Will it be a
cynical signal that human embryo cloning and destruction is okay,
acceptable, even to be encouraged, all in the name of science? Or will
it be a message urging caution and care? If we allow this research to
go forward unchecked, what will be next? Unchecked research, does it
mean that once human cloning is considered safe, we will then allow
parents to choose what color hair and eyes their baby will have? Would
we allow scientists to manufacture children with greater intelligence
in the pursuit of perfected humanity?
We need to consider all aspects of cloning, and not just what
researchers tell us is beneficial.
Opposition to the Brownback-Weldon-Stupak bill has based their
objections on arguments that it will stifle research, discourage free
thinking and put science back in the dark ages. How ridiculous. Our
bill does nothing of the sort. It allows animal cloning; it allows
tissue cloning; it allows current stem cell research done on existing
normal embryos; it allows DNA cloning. How is this stifling research?
These scientists who are pushing so hard to be allowed a free pass
for research on what constitutes the very essence of what it is to be a
human do not know what goes wrong with cloned animal embryos. The
horror stories are too many to mention here--deformed mice and deformed
sheep developing from cloned embryos.
A prominent researcher working for the bioresearch companies has
admitted scientists do not know how or what happens in cloned embryos
resulting in these deformities. In fact, he calls the procedure when an
egg reprograms DNA ``magic.''
Magic? This is hardly a comforting, hard-hitting scientific term,
but it is accurate. It is magic.
Opponents of our bill have said therapeutic cloning is the Holy
Grail of science which holds the key to untold medical wonders. To our
opponents, I say show me your miracles. Show me the wondrous advances
done on animal embryonic cloning. But these opponents cannot show me
these advances because they do not exist.
Our ability to delve into the mysteries of life grows
exponentially. All fields of science fuse together to enhance our
ability to go where we have never gone before.
The question is this: simply because we CAN do something, does that
mean we SHOULD?
Which is the better path to take? One in which we mass produce
cloned embryos in the lab, a path which will lead to producing cloned
babies? Or is the better path one urging caution, stepping forward
based on sound science guided by ethical, moral, and legal principles?
The human race is not open for experimentation and manufacture at
any level, even the embryonic level. Hasn't 20th-century history shown
us the folly of this?
Holy Grail? Magic? How about the human soul? Scientists and medical
researchers can't find it, and most importantly they can't medically
explain it. Still writers write about it; songwriters sing of it; you
and I believe in it. From the depths of our souls we know we should ban
human cloning.
Thank you.
Senator Specter. Thank you very much, Congressman Stupak. I
do have a few questions.
Senator Mack, you have put your finger right on the issue
in two sentences of your prepared statement. ``The egg cell is
never fertilized by sperm and will never be implanted into a
womb. Therefore, I do not believe it should be called an embryo
or that it is in fact human life.'' Would you amplify on your
view, what you summarized there?
Senator Mack. I sure will. Those two sentences were not
there by mistake. It is something I have given a great deal of
thought about. As I indicated in my prepared testimony, I
consider myself to be pro-life, and so the question I had to
ask is, if I am pro-life, how do I address this important
issue? It seems to me the very first question you have to ask
yourself, is this in fact human life that we are dealing with?
Two points.
One, I made the comment with respect to it should not be
called an embryo because I want to challenge the scientific
community to begin to define in essence new entities that have
not existed before in biology. The world has changed
dramatically. We cannot be using terms that were created 30,
40, 100, 200 years ago to be used in the debate about this new
technology.
The question I had to ask myself was, again, when does life
begin? I believe life begins at conception. Then the question
becomes, what is the definition of conception?
I suppose that most who accepted that notion that life
begins at conception accepted that notion without there ever
being a thought passing through their minds that at some point
in the future there would be the ability to take the nucleus
out of a somatic cell and transfer it into an egg.
Therefore, again, the purpose there is to challenge, is to
say that we need to be defining words that properly express
what is taking place today. And I just do not believe that an
egg, where the nucleus of the egg has been removed, and the
somatic cell nucleus has been replaced in it, is human life.
So, that is where I begin the discussion and I make decisions
from there with respect to whether this should be the type of
research we should pursue.
Senator Specter. Well, when we get into the question of
when life begins, we are in very deep philosophical areas.
Congressman Stupak, in your statement, you say that your
bill allows animal cloning, it allows tissue cloning, it allows
current stem cell research done on existing normal embryos, it
allows DNA cloning, what do you mean when you say that your
bill allows tissue cloning?
Mr. Stupak. Well, Mr. Chairman, as you know, any excess
embryos right now are used for research. Tissue cloning can
also be developed through the bill that we currently have
before you.
If I can summarize it, our whole objection to this is we do
not want--and we are drawing an ethical line here, maybe a
legal, and maybe even moral at the special creation of embryos
for research purposes. We need to respond to that cloning
research precisely because it involves the special creation of
cloned embryos for the sole purpose--for the sole purpose--of
research. So, you can do research right now. There are
guidelines. NIH and others are allowed to do it right now with
the excess. What we are saying, we do not want human embryo
farms, if you will, for the sole purpose of research. We think
that would be inappropriate.
Senator Specter. Are you saying that you would be willing
to see existing embryos, existing eggs used with the DNA
removed and DNA from, say, a Parkinson's patient, as long as
there are not embryos created artificially?
Senator Mack. Not created artificially. And again, you have
the adult stem cell research that is being done that shows
great promise. We think the current policy--again, even if you
take a look at President Clinton's Bioethics Commission, they
also fully recognize that any efforts in humans to transfer a
somatic cell nucleus into an enucleated egg involves the
creation of an embryo. And they said that is where we draw the
line. As long as you do not pass that line. Those are the
standards currently in the Bioethics Commission. So, that is
where we are drawing the line, Senator.
Senator Specter. So, you have an objection even if the
process does not scientifically create an embryo. You had said
in your testimony that you do not want to see embryos created.
Mr. Stupak. He says as long as you are not going to create
an embryo that is not going to planted in a woman's womb. If
you can create human embryos that can produce human when
brought to full term, how are you ever going to stop the
private doctor from implanting that into a womb in the privacy
of his office?
Senator Specter. Well, you pass a law which prohibits it
and you attach penalties to it. You have the same issue with
the Weldon-Stupak bill. You are not going to stop somebody from
doing it if they choose to violate the law, run the risk of
being apprehended and punished.
Mr. Stupak. See, what we are saying in the Weldon-Stupak-
Brownback bill is do not even start down that, do not start
using human cloning because once you do this, the next step is
to plant it in the womb for your human cloning. How do you stop
it then? Why even open the door to it until we know where we
are going with this whole situation in medical research?
Senator Specter. I understand the slippery slope argument,
but the effect of a prohibition would be the same in your bill
if you say you cannot have human cloning. There is a consensus
not to have human cloning.
When you come to grips with the core as to what Senator
Mack has said, the egg cell is never fertilized by sperm and
will never be implanted in a womb. Do you disagree with the
assertion that there is a risk that it will be implanted in a
womb?
Mr. Stupak. Yes.
Senator Specter. Well, how is your bill any more effective
in stopping implanting in a womb than the Harkin-Specter bill
which prohibits implanting it in a womb?
Mr. Stupak. Our bill says, look, we need to respond at
research cloning. We do not want research cloning farms, if you
will. You have ACT up in Massachusetts. You have China. You
have others who are saying we are going to mass produce human
cloning. We will pick and choose what we want. We discard the
rest. That is what we do not want to see happening, and that is
where I think our bill differs from the other bills out there.
On the House side, it was the Greenwood bill.
Senator Specter. I think Congressman Greenwood and others
and I would be willing to ban the so-called embryo farms and
ban human cloning.
Let me ask you this question. Recently there have been
comments about being able to help someone who has Alzheimer's
in their background. You have raised the issue about where you
go on unchecked research creating the option of hair color and
eyes, which I grant you is along a, perhaps, frivolous line.
But what if you have an Alzheimer's gene and scientists have
the capability to help an individual who has that Alzheimer's
gene and had it in the family for generations? What if you have
an opportunity, when that individual is having a child, to
alter that gene to preclude Alzheimer's would you disagree with
that?
Mr. Stupak. Well, we think our bill, because it does allow
embryo stem cell research, that your hope for Parkinson's, from
what medical science tells us, probably lies best right there.
We do not prevent embryo stem cell research. Even the opponents
of the bill admitted during the debate on July 31 on the floor
that our bill to ban embryonic stem cell research is not before
us. That was not the issue before us. We still allow medical
science to go forward, whether it is animal cloning, tissue
cloning, stem cell research, DNA cloning. We allow that. What
we are saying is do not create life and then disregard what you
do not want. That is what we are in fear of.
I know you said abandon the farm. It is more than just
abandoning the farm. Are we really abandoning some basic
ethical, moral, and legal principles? This is a debate we
should have as a country. And I am glad to see the Senate and
the House has had that debate.
And that is why those who voted for our ban in the House
were not just pro-lifers or those against stem cell research or
other research. They looked at the merits of the total bill,
and when they looked at it, they said, as the Bio Commission
under President Clinton said, there is a legal, ethical, and
moral line we should not cross. And our bill allows the
research without crossing that line.
So, I am pleased to be here today to join you in this
debate.
Senator Specter. Well, come back to my question. I have not
gone into the stem cells. Frankly, I would like to, but we have
another panel of witnesses. But come back to the question I am
asking you, which is a very narrow question.
I will agree with you that we should not alter genes for
the color of eyes or hair, but should we alter the gene if you
can preclude the next generation from having Alzheimer's?
Mr. Stupak. No, you should not. But what we are saying is
do not create life and then take the gene you want and then
abandon that life.
Senator Specter. Well, you would not be abandoning the
life. You would simply have the embryo with a modification to
take away the gene that would otherwise cause the individual to
have Alzheimer's.
Mr. Stupak. And that embryo, if you will, would grow on to
life if you allowed it to naturally develop. Correct?
Senator Specter. Correct.
Mr. Stupak. So, you are going to start modifying life in
order to a cure somewhere else. That is where we have the
problem.
Senator Specter. You disagree with modifying the gene to
stop that individual-to-be from having Alzheimer's.
Mr. Stupak. Oh, I thought you said modify the embryo to
take a benefit to give to another embryo.
Senator Specter. Well, scientists have a way, they say, now
to alter the gene which causes Alzheimer's. And my question to
you is, would you agree that it would at least be worthwhile to
allow scientists to do that?
Mr. Stupak. And I believe with the DNA cloning, that is
allowed in our legislation. You could accomplish that, yes. We
allow that DNA cloning in our bill. We do not prevent it.
Senator Mack. Mr. Chairman, if I may make a couple
additional comments.
Senator Specter. I was just about to ask you to do that,
Senator Mack.
Senator Mack. With respect to the term ``farming,'' it does
bring up all kinds of pictures, I am sure, in everybody's mind
that here is that phraseology. I am sure that if you go back
and listen to the debates, for example, about human organ
transplants, the terms that were used like ``harvesting'' and
``farms,'' and this was a terrible thing we were moving into.
The reality is that because someone who supports my position
that somehow or another as lost their moral sense or their
ethical track and would not put in place things to keep markets
from developing and farms from being created is a real stretch
from my perspective.
I guess an additional point that I would like to make is
that there is the impression that when a new technology comes
along, that there is no ability to control it. It has either
got to be used all for good or all for evil. But I would make
the point that the core of all human progress is rooted in our
ability to manage the harmful consequences of innovation. That
has been the history of humanity.
You could make the same argument about fire. I am sure that
sitting around in darkness years ago, there were some real
warnings about what could happen if this new technology, fire,
got into the wrong hands. And sure enough, there are dangers,
but that does not mean we should eliminate that progress that
can come from that new technology. I think that our society has
indicated over and over and over again the ability to control
the environment around these new innovations that we develop.
Senator Specter. Congressman Stupak, you mentioned your
bill does not limit stem cell research, and as we all know, the
President allows Federal funding to be used on stem cells in
existence as of August 9 at 9 p.m. when he made his speech. Do
you believe that that limitation is sound, just to cut off
Federal funding on stem cell research as of that date and that
time because that was the time of the President's speech?
Mr. Stupak. Well, I think the President at that time and
that date, based upon the best information available to him,
made that decision. But I also believe the President said he
would leave the door open for further review. And if there is
sound medical purpose to go forward, he would review it at a
later date. But based upon the information, the strands known
at that time, that is what he thought was the most prudent
action. And I support him in that position. But I did not think
he forever closed the door. I thought he left it open for
further research.
Senator Specter. So, you would say that if those stem cell
lines are inadequate for research, that you would consider
using stem cell lines developed at a later time.
Mr. Stupak. Yes, I would. Again, our bill does not
prohibit. We do not put number of lines in there as of 9 p.m.
on a certain evening. We just said you still can do your stem
cell research in our legislation.
Senator Specter. Senator Mack, what would you say--and I
intend to quote you on the Senate floor--would be the kernel
and the strongest argument to tell our pro-life colleagues in
the Senate. And Senator Thurmond testified at that table and in
that chair in the same way.
Senator Mack. In the same way? I am just kidding.
Senator Specter. Not in an identical way.
Senator Mack. Not in a cloned way. Is that what you are
trying to say?
Senator Specter. That is right.
Not identical twins. But if any of us does as well at 99\1/
2\ as Strom is doing today, it would be a great tribute to all
of us.
But I reference Senator Thurmond's testimony, because he is
in favor of nuclear transplantation.
But to sum up. What would the argument be, since you will
not be on the Senate floor to advance it, to tell your ex-
colleagues, who have a great deal of respect for you, why a
strong pro-life Senator like Connie Mack favors nuclear
transplants and stem cell research?
Senator Mack. I think I would start by asking them to
consider the base of knowledge that we have today compared to
what knowledge we had 15, 20, 30 years ago. And the point that
I am making there is that as new knowledge is developed, it
gives you a new way to look at issues that are challenging you.
Not that you change your perspective with respect to your
values, but the new knowledge creates a new environment in
which to take a look at the question of whether we should allow
somatic cell nuclear transfer.
And that is why I raised the question in my testimony about
the whole issue of life. Bart has indicated, and I think quite
accurately, that if it is human life, it has to have special
treatment. But there are those of us who believe that there is
something fundamentally different between an egg that is
fertilized by a sperm and in the womb versus an egg that has
received a somatic cell nuclear transfer and will never be
placed in a womb and will never be able to develop.
I believe I am correct in this, that the blastocyst, which
is a phase that the cells go through in development, does not
normally attach to the womb until after the blastocyst stage.
The point is, from my perspective, again it is not human life
if it has not been fertilized by sperm. It is not human life it
has not been placed in the womb.
I go right to the heart of the issue. I suspect that there
would be people who could conclude that it is some form of
human life. Then the question becomes, well, what kind of legal
protections does that some kind of human life receive? And I
think the question then becomes one of, well, what are the
potential benefits by continuing the research even under those
circumstances.
So, I think there is a series of places that Members are
going to find themselves in this debate, but to me you have to
start fundamentally with asking the question when does life
begin, is this life, and then move from that point on.
Senator Specter. So, your essential point is that it is not
conception and therefore not life.
Mr. Stupak. If I may just----
Senator Specter. Congressman Stupak, I was going to ask you
if you had any concluding comments.
Mr. Stupak. Sure. I think maybe there is a little
difference between myself and my friend, Connie Mack here.
I asked that question at the hearing. I sit on the Energy
and Commerce Committee, the Health Subcommittee. And when the
experts came to testify, the commission, the National
Biological Advisory Commission, President Clinton's Bioethics
Commission, Mr. Tom Okamara, I asked the question. I said, the
blastocyst. Is that not really another term for an early living
human embryo? The answer was, yes it is, absolutely.
And we do not mean to obfuscate the intent or the actuality
about what we are talking about here. So, what we are saying,
even a blastocyst that my friend talks about--if the expert
tells us it is a living human embryo, how can you manipulate,
modify it for the benefit of another?
Senator Specter. Okay. Thank you very much, Senator Mack,
Congressman Stupak. We very much appreciate your being here.
We now turn to our next panel: Dr. Gerald Fischbach, Mr.
Silviu Itescu, and Mr. Kevin Kline.
Dr. Fischbach is vice president for Health and Biomedical
Sciences, Dean of the Faculty at the School of Medicine at
Columbia. He was the Director of the National Institute of
Health for Neurological Disorders and Stroke. Prior to his
appointment as Director, Dr. Fischbach served as director of
the Neurobiology Departments of the Harvard Medical School and
the Massachusetts General Hospital. His M.D. is from Cornell
University Medical School.
Welcome, Dr. Fischbach. You have been very generous with
your time to this subcommittee on a number of occasions, and we
thank you for coming again today and look forward to your
testimony.
STATEMENT OF GERALD D. FISCHBACH, M.D., EXECUTIVE VICE
PRESIDENT FOR HEALTH AND BIOMEDICAL
SCIENCES, DEAN OF THE FACULTY OF MEDICINE,
COLUMBIA UNIVERSITY
Dr. Fischbach. Thank you, Senator Specter. I want to thank
you for inviting me back to comment on the important subject of
this committee's hearing.
This committee, led by you and Senator Harkin, has inspired
this Nation's scientists and given great hope to millions of
patients in this country by your work here in furthering
research in this country.
I am the vice president for Health and Biomedical Sciences
at Columbia. I am here today representing the Coalition for the
Advancement of Medical Research which represents 60
universities, scientific societies, and patient advocacy
groups.
I want to do a few things in the next 4 minutes. First, I
want to reiterate my support for human embryonic stem cell
research. There is no question that this research has enormous
promise in a new type of restorative or regenerative medicine
in which we will be able to treat devastating, degenerative
disorders not merely by treating their symptoms, but by
stopping the course of the disease and perhaps even reversing
some of the processes underlying the disease. And by that, I
mean the ones we have talked about in the past involving the
nervous system and also degeneration of cells in the pancreas
that lead to diabetes and degeneration of cells in the heart
and other tissues of the body.
There have been a number of successes in the past 3 or 4
years after the initial discovery of human embryonic stem
cells. Stem cells have been used in animal models to reverse
the course of Parkinson's disease. They have been used to
repair spinal cord injury. They have been used to minimize the
damage in stroke. They have been used to reverse almost all of
the symptoms of diabetes in animal models.
The second point I want to emphasize is that somatic cell
nuclear transfer would greatly facilitate research on embryonic
stem cells. It would increase the supply of cells and it would
answer in large part, if not entirely, one of the main
remaining problems, that is, the rejection of cells once they
are implanted and after they have initially been shown to be
successful.
One of the great tragedies of this type of research would
be the reversal of fortune after an initial success. Somatic
cell nuclear transfer, for technical reasons I would be glad to
discuss later, offers the possibility of minimizing rejection
of stem cells once implanted.
Third, I want to make clear that I do not support attempts
at human cloning. I distinguish human cloning from somatic cell
nuclear transfer, and I know of no responsible scientist who is
in favor of nuclear cloning at this point. There are too many
unknowns. It is inconceivable that we would produce another
Arlen Specter or another Kevin Kline. There are instantaneous,
every-instant interactions with our environment and
modifications of our genetic makeup that distinguish one
individual from another. So, the possibility of human cloning
is beyond our scientific reach and imagination today.
Finally, I want to comment on one aspect of the Landrieu-
Brownback bill which criminalizes work on stem cells derived
from young embryos created by somatic cell nuclear transfer.
These criminal penalties would be placed on scientists and on
patients that seek treatments developed in other countries such
as Great Britain where SCNT is currently legal. Under this
bill, Americans who travel to another nation to benefit from
the medical technology, denied to them in the United States,
would be considered criminal. If a cure or a treatment were
developed in another country using nuclear transplantation,
Americans would be alone in the world in being unable to take
advantage of such treatment.
Largely as a result of this committee's leadership,
American biomedical science has flourished these past several
years. Increased funding, I believe, has been managed
extraordinarily well by Federal agencies, and real advances
have been made in many areas crucial to the physical and mental
health of this country.
I believe that criminalizing this type of work will cast a
pall over the country's scientific effort. Individuals are not
undertaking research for research's sake. Most of them are
undertaking research to help improve the health of this Nation,
and I think the criminal implications would have aspects that
reach far beyond somatic cell transfer.
We all have ethical obligations. We have talked about the
very profoundly troubling ethics of the derivation of stem
cells, but we all have ethical obligations to our parents, our
children, and our colleagues who suffer from debilitating
disorders. We must do all we can to alleviate them. We cannot
approach such critical matters with one hand tied behind our
backs. We must be able to pursue this promising, extremely
promising, area of medical research with the full force of our
intellect and abilities.
I believe if this bill passes, it will stand in the way of
the ability of scientists and physicians to treat their
patients with the best tools available.
[The statement follows:]
Prepared Statement of Dr. Gerald D. Fischbach
Mr. Chairman, Senator Specter, members of the Committee, thank you
for inviting me here today to testify before you about this most
important topic. I am pleased to join the other respected witnesses
this morning. For the Record, my name is Gerald D. Fischbach, Executive
Vice President for Health and Biomedical Sciences at Columbia
University. I also serve as Dean of the Faculty of Medicine at the
Columbia University College of Physicians and Surgeons.
I am here today representing the Coalition for the Advancement of
Medical Research (CAMR). The coalition is comprised of more than 60
universities, scientific societies, patients' organizations, and other
entities.
There are three major points I would like to discuss this
afternoon: reproductive cloning, nuclear transplantation, and the
denial of medical treatments developed in other countries to Americans.
To begin, I want to make it as clear as possible that no
responsible scientist that I know of supports efforts to clone a human
being. As stated in the recent National Academies of Science report on
the topic, ``it is dangerous and likely to fail.'' In testimony on this
issue before other Senate Committees, my esteemed colleagues Paul Berg
and Irv Weissman have made that point clear and I echo their remarks.
This is something upon which we can all agree.
The second point I would like to make revolves around the portion
of the Landrieu/Brownback bill that criminalizes a scientific procedure
known as nuclear transplantation. I should begin by pointing out that,
despite what one might see in science fiction and horror movies, not
all cloning is bad. In science, the term ``cloning'' describes the
preparation of an infinite number of copies of a single molecule,
virus, or bacterium.
DNA cloning has been used to map out the human genome sequence. It
has been used to uncover genes that cause human diseases such as
Alzheimer's disease, heart disease and many forms of cancer. It is used
to identify the nature and origin of dangerous bacteria in the fight
against bioterrorism. DNA typing is used in many modern forensic
procedures, allowing the innocent to be freed and the guilty to be
convicted.
Cloning has also been used in the production of many important
drugs such as human insulin. The cloning of cancer cells from cancer
patients is a procedure that has been done for years in an effort to
identify promising cancer therapies.
S. 1899 would deny Americans access to treatments for some of the
most debilitating diseases known to medicine. Without being able to
match new treatments with an individual's own DNA, our ability to cure
and treat disease may well be greatly hindered. It would also bring
about a serious chill on scientific research in the United States. If
this procedure is deemed to be unacceptable by some and therefore made
illegal, what assurance does the next generation of scientists have
that their particular field of cutting edge investigations might not
also suffer the same fate? Given that uncertainty, who among us would
take the risk of pursuing a career in science? We are at a point in
history when we need young researchers to forge new scientific
frontiers in an effort to fight bioterrorism and battle disease.
Labeling them as criminals undermines these efforts and does no good.
Finally, Mr. Chairman, the third point I would like to discuss is
the importation portion of the S. 1899 that has, for some unknown
reason, gained little or no attention. This section of the bill enacts
criminal penalties against doctors and patients who seek to access
treatments developed in other countries using nuclear transplantation.
Under this bill, physicians could not treat their sick patients with an
effective treatment developed overseas using nuclear transplantation.
Similarly, an American who travels to another nation to take advantage
of a medical technology unavailable in the United States could be
considered a criminal. If a cure or treatment for Parkinson's disease
or Alzheimer's disease were developed in another country using nuclear
transplantation, Americans could be alone in being unable to take
advantage of that treatment. I cannot believe that the United States
Senate would pass such legislation.
Doctors, like Senator Frist and I, have an ethical obligation to
our patients to do all we can for them. This bill, if passed, sharply
curtails the ability of doctors to properly treat their patients.
Those in support of this legislation argue that these drastic
measures are necessary to prevent a slide down the slippery slope of
medical horrors that we all deem unacceptable. I disagree with that
line of reasoning. Despite the wild claims that some supporters of S.
1899 have made in their ads, we can prevent reproductive cloning
without interfering with science. The bill that the Chairman and
Ranking Member have sponsored, S. 1893, does just that, as does Senator
Feinstein's bill.
I implore you, ban reproductive cloning, but do not make somatic
cell nuclear transfer (therapeutic cloning) illegal. SCNT holds the
potential to help scientists find cures for such debilitating diseases
as ALS, Parkinson's, Juvenile Diabetes, and others. Chairman Harkin and
Senator Specter, largely as a result of your leadership, support for
biomedical research in this country has risen tremendously in recent
years. It would be a sad and strange irony that, if at the same time
the resources we have at our disposal are increasing, this Congress
were to take away such a powerful and important research tool. Thank
you.
Senator Specter. Thank you very much, Dr. Fischbach.
We now turn to Dr. Itescu, director of Transplantation
Immunology, Columbia Presbyterian Medical Center, New York-
Presbyterian Hospital. He is a member of the American Board of
Internal Medicine and a consultant for global clinical affairs
of CSL Limited. He received a bachelor of medicine and bachelor
of surgery from Monash University School of Medicine,
Melbourne, Australia.
Thank you for joining us, and we look forward to your
testimony.
STATEMENT OF SILVIU ITESCU, M.D., DIRECTOR,
TRANSPLANTATION IMMUNOLOGY, NEW YORK-
PRESBYTERIAN HOSPITAL, COLUMBIA UNIVERSITY,
NY
Dr. Itescu. Thank you very much. I would like to thank the
committee for inviting me here to speak really on some
alternative type of stem cells and where I think some aspects
of research are going and some areas where I think we should
progress perhaps more slowly rather than jump in.
I am director of Transplantation Immunology at New York-
Presbyterian Hospital of Columbia University, and my field is
to provide specialist input into the use and management of
immunosuppressive drugs for patients with various solid organ
transplants, most notably the heart.
Congestive heart failure remains a major public health
problem. In western societies, it is primarily the consequence
of a previous heart attack. Current therapy of heart failure is
limited to the treatment of already established disease and is
really pretty insufficient. For patients with end-stage heart
failure, the current treatment options are extremely limited,
and less than 3,000 patients are offered heart transplants
annually due to the severely limited supply of donor organs.
So, clearly, development of approaches that prevent heart
failure would be preferable to those that simply ameliorate
established disease.
My research group has recently identified a specific
population of stem cells in human adult bone marrow which can
be delivered to the heart after a heart attack and enables the
development of many tiny blood vessels. In a well-characterized
animal model, this results in protection of heart muscle cells
against death through starvation and results in long-term
improvement of heart function. We have recently received NIH
approval to support funding of further research using these
adult stem cells, and are in the process of obtaining our
institutional IRB approval to begin safety studies of this
therapy.
The notion that adult tissues contain stem cells, other
than those needed to reconstitute bone marrow elements, is
relatively new, particularly with respect to regeneration of
tissues that are not normally renewed, such as heart, neuronal,
or muscle. In recent years, several investigators have shown
that neural stem cells, as well as hematopoietic and other
types of stem cells, can be identified and obtained from adult
tissues and that such cells can give rise to different tissues
such as liver, brain, blood, or muscle, suggesting really the
presence of one or more types of typical pluripotent stem cells
in adults.
While the full developmental options of such adult stem
cells are not fully known, it has become evident that when you
put such cells into one area, they can transform into a
different type of cell, and that is called
transdifferentiation. More recently, adult bone marrow-derived
cells, when injected into the spinal cord of rats, for example,
with spinal cord transection, transdifferentiated to become
myelin-producing cells. There are many examples of such
situations where differentiation to neurons and other tissues
has been shown. Such investigators have suggested that bone
marrow cells could, in principle, be harvested from a patient
and used for a potential cell therapy for diseases such as
neurodegenerative diseases.
What all of these recent studies have in common is to
emphasize the potential for use of adult tissue as an
alternative to embryonic tissue. If in fact adult tissues
contain multipotent stem cells capable of sufficient self-
renewal and differentiating capability, this would provide a
far more elegant and preferred approach since autologous cells
will not induce any immunological reaction and no
immunosuppression will be needed. In contrast, embryonic stem
cells will always be seen as foreign by the recipient and some
degree of immunosuppression is likely to be required.
While adult bone marrow stem cells appear to have the
ability to replicate to greater levels than other adult cells,
it is true that they do not have as great a self-renewal
capacity as embryonic stem cells. Whether or not the degree of
self-renewal of an embryonic stem cell is critical is at
present not known, and it is likely, for example, that
sufficient blood vessel stem cells might be obtained from the
bone marrow of a single donor in order to create sufficient
blood vessels to enable improvement in heart function.
However, let me just emphasize that as an active
investigator and clinician in the field of stem cell biology, I
fully support unimpeded funding for ongoing research efforts
into both adult and embryonic stem cells. It is too early at
present to say whether one or the other type of stem cell
approach will prove to be superior for a given disease. But it
is probably fair to say that one cell type will not be the
answer for all tissue regenerative needs.
Although I am confident that adult stem cells will be the
preferred or most adequate way to treat cardiovascular disease,
it is too early to make similar conclusions about other disease
states such as neurological disorders or diabetes. In these
areas, investigators using both types of stem cells are making
rapid progress, and future studies will require side-by-side
comparisons of each approach.
Major questions concerning the use of embryonic stem cells
remain regarding their efficacy for treating various disease
states and response to differentiation protocols. In addition,
issues about their immunogenicity need to be addressed. So, we
come to the potential use of therapeutic cloning of recipient
somatic cells using donor eggs.
The concept that these would not be rejected by the
recipient's immune system is a solid theoretical argument, data
in animal models supporting this concept is scarce. In fact, in
last week's issue of Cell, a report by Dr. Jaenisch and
colleagues outline an extremely unexpected finding, namely
rejection of cloned mouse embryonic stem cells which were
genetically identical to the recipient by a specific arm of the
recipient's own immune response which recognized the cells as
foreign. The author suggests that the cloned stem cells were
seen as foreign due to their early developmental stage, but it
is just as possible that some aspect of the cloning process
contributed to their acquiring a foreign nature. As Dr.
Jaenisch and his colleagues conclude: ``Our results raise the
provocative possibility that even genetically matched cells
derived by therapeutic cloning may still face barriers to
effective transplantation for some disorders.''
This emphasizes the early nature of this line of research
and highlights the numerous unexpected hurdles that will likely
be faced in re-educating the immune system when cloned
embryonic stem cells are introduced into a recipient. Moreover,
the very process of cloning itself is poorly understood, with
investigators having little insight into the causes of its
extreme inefficiency, association with abnormal aging, and risk
of genetic abnormalities.
Consequently, I believe that consideration of therapeutic
cloning of human embryonic stem cells for clinical use is
premature. I am concerned that permitting unconditional
approval of human embryonic stem cell cloning will result in
premature forays into clinical trials by adventurous commercial
entities. As outlined above, we need to firstly define which
particular diseases are best treated by adult stem cells and
which by embryonic stem cells. For those diseases where adult
stem cells will not be an option, much work is then needed to
understand how to manipulate and differentiate human embryonic
stem cells in order to optimize efficacy and minimize risks
such as cancer. In parallel, much work should be done in animal
models to define methodologies and assess outcomes of using
cloned embryonic stem cells. Strict regulation of human
embryonic stem cell cloning would not halt progress in these
key areas. It will merely ensure the same stringent criteria
and safety checks that are applied to other novel therapeutic
approaches for human disease.
Rather than delay important research, I believe a
moratorium on the clinical use of cloned human cells will
prevent hasty and premature experimentation in human subjects
without adequate scientific diligence and rigor. For those
disease states where embryonic stem cells might be shown to
have an advantage over adult cells, their use will be unimpeded
in the shorter term by such strict regulatory oversight since
they could be used together with low doses of the same
immunosuppressive agents currently used to give the average
kidney transplant recipient over 10 years of disease-free
survival. Therefore, a moratorium on the clinical use of cloned
human cells is prudent, encourages much-needed additional work
with both human stem cell and cloning technologies, enables
close scrutiny of advances in these fields, and allows for
review on an intermittent basis to assess the state of
scientific progress.
Thank you.
[The statement follows:]
Prepared Statement of Dr. Silviu Itescu
I am Silviu Itescu, Director of Transplantation Immunology at the
New York-Presbyterian Hospital of Columbia University in New York. I
run a clinical service that provides specialist input into the use and
management of immunosuppressive drugs for patients with various solid
organ transplants, most notably the heart. Congestive heart failure
remains a major public health problem, with recent estimates indicating
that end-stage heart failure with two-year mortality rates of 70-80
percent affects over 60,000 patients in the United States each year. In
Western societies heart failure is primarily the consequence of
previous myocardial infarction or heart attack. Current therapy of
heart failure is limited to the treatment of already established
disease and is predominantly pharmacological in nature. For patients
with end-stage heart failure treatment options are extremely limited,
with less than 3,000 being offered cardiac transplants annually due to
the severely limited supply of donor organs. Clearly, development of
approaches that prevent heart failure after myocardial infarction would
be preferable to those that simply ameliorate or treat already
established disease.
My research group has recently identified a specific population of
stem cells in human adult bone marrow which can be purified and
delivered to the heart after a myocardial infarction, enabling the
development of many new tiny blood vessels. In a well-characterized
animal model this results in protection of heart muscle cells against
death through starvation and results in long-term improvement in heart
function. We have recently received NIH approval to support funding of
further research using these adult stem cells, and are in the process
of obtaining our institutional IRB approval to begin safety studies of
this therapy in patients with cardiovascular disease.
The notion that adult tissues contain stem cells or progenitors
other than those needed to reconstitute bone marrow elements is
relatively new, particularly with respect to regeneration of tissues
that are not normally renewed, such as cardiac, neuronal or striated
muscle. In recent years, several investigators have shown that neural
stem cells, as well as hematopoietic and mesenchymal stem cells, can be
identified and obtained from adult sources and may give rise to
different tissues such as liver, brain, blood, or skeletal muscle,
suggesting the presence of one or more types of truly pluripotent stem
cells in adults.
While the full developmental options of a given adult stem cell are
not yet known, it has recently become evident that environmentally
dictated changes of fate may involve progenitor cells at different
steps of a given differentiation pathway (trans-differentiation). The
adult bone marrow appears to be a particularly rich source of
progenitor cells capable of trans-differentiation to cells of various
lineages. A striking example of this was the demonstration that
transplantation of bone marrow hematopoietic stem cells into
genetically defective mice with liver disease resulted in regeneration
of liver nodules. In addition to the trans-differentiation potential of
hematopoietic stem cells, adult bone marrow cells have been reported to
differentiate into neurons when transplanted into normal and ischemic
brain. More recently, adult bone marrow-derived cells injected into the
spinal cord of rats with spinal cord transection trans-differentiated
to become myelin-producing cells. These investigators have suggested
that bone marrow cells could, in principle, be harvested from a patient
and be used for potential cell therapy approaches in neurological
disease.
What all of these recent studies have in common is to emphasize the
potential for the use of adult tissue as an alternative source of stem
cells to embryonic tissue. If in fact adult tissues contain multipotent
stem cells capable of sufficient self-renewal and differentiating
capability for use in clinical tissue regeneration, this would provide
a far more elegant and preferred approach since autologous cells will
not induce any immunologic rejection and no immunosuppression will be
needed. In contrast, embryonic stem cells will always be seen as
foreign by the recipient, and some degree of immunosuppression is
likely to be required. While adult bone marrow stem cells appear to
have the ability to replicate to greater levels than other adult,
differentiated cell types, it is true that they do not have as great a
self-renewal capacity as embryonic stem cells. However, at present it
is not known what degree of self-renewal capacity is needed in order
for a stem cell to be capable of providing sufficient progeny for
clinical use. For example, it is likely that sufficient blood vessel
stem cells can be obtained from the bone marrow of a single donor in
order to create sufficient new blood vessels to enable improvement in
heart function.
As an active investigator and clinician in the field of stem cell
biology I fully support unimpeded funding for ongoing research efforts
into both adult and embryonic stem cells. It is too early at present to
say whether one or the other type of stem cell approach will prove to
be superior for a given disease, but it is probably fair to say that
one cell type will not be the answer for all tissue regenerative needs.
Although I am confident that adult stem cells will be the preferred and
most adequate way to treat cardiovascular disease, it is too early to
make similar conclusions about other disease states such as
neurological disorders or diabetes. In these areas investigators using
both types of stem cells are making rapid progress, and future studies
will require side-by-side comparisons of each approach.
Major questions concerning the use of embryonic stem cells remain
regarding their efficacy for treating various disease states, risk of
cancerous transformation, and response to differentiation protocols. In
addition, issues about their immunogenicity need to be addressed. In
order to overcome the last problem, which is also the major perceived
advantage of adult stem cells, a number of investigators have suggested
the use of ``therapeutic cloning'' of recipient somatic cells using
donor eggs. The resulting embryonic stem cells would have all of the
genetic material of the recipient, and thus not be rejected by the
recipient's immune system.
While this is a scientifically solid theoretical argument, data in
animal models supporting this concept are scarce. In fact, in last
week's issue of Cell a report by Jaenisch and colleagues outlined an
extremely unexpected finding, namely rejection of cloned embryonic stem
cells genetically identical to the recipient by a specific arm of the
recipient's immune response which recognized the cells as foreign due
to their early developmental stage. This emphasizes the early nature of
this line of research, and highlights the numerous unexpected hurdles
that will likely be faced in re-educating the immune system. Moreover,
the very process of cloning itself is poorly understood, with
investigators having little insight into the causes of its extreme
inefficiency, association with abnormal cellular senescence, and risk
of genetic abnormalities. Whether cloned embryonic stem cells will
demonstrate similar defects, whether they will have greater
susceptibility to cancerous transformation, and more importantly
whether the regenerative potential of such cells is affected by the
cloning process itself, is at present unknown. These questions will
need to be adequately addressed in numerous animal models before one
would consider performing such studies in humans.
I believe that consideration of therapeutic cloning of human
embryonic stem cells is premature. As outlined above, we need to
firstly define which particular diseases are best treated by adult stem
cells and which by embryonic stem cells. For those diseases where adult
stem cells will not be an option, much work is then needed to
understand how to manipulate and/or differentiate human embryonic stem
cells in order to optimize efficacy and minimize risk of cancer. In
parallel, much work should be done in animal models to define
methodologies and assess outcomes of using cloned embryonic stem cells.
A moratorium on human embryo cloning would not halt progress in these
key areas, it will merely ensure the same stringent criteria and safety
checks that are applied to other novel therapeutic approaches for human
diseases. Rather than delay important research, I believe a moratorium
on human cloning will prevent hasty and premature experimentation in
human subjects without adequate scientific diligence and rigor. For
those disease states where embryonic stem cells might be shown to have
an advantage over adult stem cells, their use will be unimpeded by such
a moratorium since they could be used together with low doses of the
same immunosuppressive agents currently used to give the average kidney
transplant recipient over ten years of disease-free survival. A
moratorium on human embryo cloning is prudent, encourages much-needed
additional work with both human embryonic and cloning technologies,
enables close scrutiny of advances in these fields, and should be
reviewed on an intermittent basis to assess the state of scientific
progress.
Senator Specter. Thank you very much, Dr. Itescu.
We now turn to Mr. Kevin Kline who won an academy award for
his performance in ``A Fish Called Wanda.'' He is known for his
roles in ``Sophie's Choice,'' ``Dave,'' and ``Soapdish.'' He is
a graduate of the Julliard School of Drama, received the
Shakespeare Award for classical theater from the Shakespeare
Theater here in Washington, as well as two Obie Awards. Thank
you for joining us, Mr. Kline, and we look forward to your
testimony.
STATEMENT OF KEVIN KLINE, ACTOR
Mr. Kline. Thank you, Mr. Chairman. Thank you for the
opportunity of appearing before you.
As you said, my name is Kevin Kline. I am an actor. I am
also a member of the board of the directors of the New York
Chapter of the Juvenile Diabetes Research Foundation, serving
as vice president of Public Outreach and Education. Today I
appear simply as a private citizen who, like many others, has
witnessed firsthand the devastating ravages of diseases such as
Alzheimer's, diabetes, and Parkinson's, and who, like many
others, have seen a bright light at the end of the tunnel, that
light being the hope given by the potential promise of stem
cell research.
Medical research is finally moving beyond the ability to
describe dysfunctional, disease-causing cell behavior to being
able to change cell activity in order to eliminate disease and
deterioration of organs and tissue. We are all privileged to be
alive at the beginning of the most promising era in life
science and I am deeply troubled that critical scientific
research may meet extinction at the hands of legislation
pending before this Congress.
Throughout our history medical science has brought
miraculous cures, often in the face of strong opposition by
those who fear that scientists are going too far and are
tampering with nature. In this country, our Government has
always had the wisdom to regulate not prohibit cutting edge
scientific research.
The efforts of the global scientific community have made it
possible to create cells with the DNA of patients to be treated
using unfertilized eggs and a scientific technique called
nuclear transplantation. Nuclear transplant research may be the
key to helping scientists understand why cells malfunction and
how to deprogram and reprogram these cells to function
normally.
The Senate is considering whether to make the conduct of
promising nuclear transplant research a Federal criminal
offense. Opponents of nuclear transplant research chide
patients and parents not to be hoodwinked by the biotechnology
industry, which they warn us is promoting scientific research
for financial gain, which parenthetically I do not understand
why we give credence and billions of dollars to our Nation's
scientists who develop smart bombs and fantastic defense
systems, and yet we are suspicious of our medical scientists
who are developing medical technologies, accusing them of doing
so for financial gain.
Opponents further admonish the scientific community not to
raise the hopes of sick children and adults and their families
now when a cure may be far away. With all due respect, these
families are not listening to salesmen. They are listening to
scientists, and they are not naive. These families know as much
about their children's diseases as many doctors. They have made
it their business to do so. Many families have seen hereditary
conditions ravage their loved ones for generations. These
families and their loved ones deserve access to the best
medical treatment that we hope will result from future
research.
I am not a scientist. I have not even played a scientist on
TV.
But I know that the majority of the brightest minds in
science throughout the world believe that this research is not
only promising, but that stem cell research and nuclear
transplantation could represent a new frontier in medicine and
potentially a giant step in the history of man's quest to ease
human suffering.
I know there are those who disagree. There always have been
and there always will be. And I thank God that we live in a
country where freedom of thought and the right to private
judgment in matters of conscience is allowed. Scientific
inquiry and religious dogma have, by their nature, always been
uneasy bedfellows.
Now, if you have made a decision to say no to the
possibilities of this research or, like some, contend that even
if we had a cure using nuclear transplantation, you would not
use it, then it is your inalienable right, and I doubt that I
will be able to change your mind. But please, I implore you, do
not deny the rest of us our access to the best medical
technology available or the fruits of the best medical
researchers. And if the next miracle comes from Canada or
England, Ireland, Scotland, or Sweden, I want to be allowed to
take my child there and not face imprisonment when we return,
as the Brownback legislation mandates.
I believe there is no moral high ground in letting people
suffer and die in staggering numbers because of a fear of
something clearly that no one wants: human reproductive
cloning. Congress can and should ban reproductive cloning.
I think, on the contrary, though, we have a great moral
obligation to pursue this new scientific research. In America,
we have the best and brightest medical minds in the world. One
need only spend a few minutes in the pediatric ward of a
hospital in order to see perhaps a 5-year-old child with no
hair on his head from chemotherapy or the look on the face of a
child just diagnosed with juvenile diabetes, condemned to an
abbreviated lifetime of insulin injections and the continual
fear of complications, such as kidney failure, blindness, or
amputation. In the face of this, it is impossible to walk away
without thinking it is shameful not to pursue any and all
promising research that could lead to a cure or prevention.
If we criminalize those who have dedicated their lives to
our health, if we allow millions of people to die every year
because we fear science, then we have not taken the moral high
ground. Rather than criminalize it, I believe the Government
should fund this research and regulate it.
Thank you.
[The statement follows:]
Prepared Statement of Kevin Kline
My name is Kevin Kline. I am an actor and the Vice-President of
Public Outreach and Education for the New York Chapter of the Juvenile
Diabetes Research Foundation. Today I appear as a private citizen, who,
like so many others, has witnessed first hand the devastating ravages
of diseases such as Alzheimer's, diabetes and Parkinson's, and, too,
like many others have seen a bright light at the end of the tunnel--
that light being the hope given by the potential promise of stem cell
research.
Medical research is finally moving beyond the ability to describe
dysfunctional, disease-causing cell behavior to being able to change
cell activity in order to eliminate disease and the deterioration of
organs and tissue. We are all privileged to be alive at the beginning
of the most promising era in life science and I am concerned that
critical scientific research may meet extinction with legislation
pending before this Congress.
Throughout history, medical science has brought us miraculous
cures, often in the face of strong opposition by those who fear that
scientists are going too far and are tampering with nature. In this
country, our government always has had the wisdom to regulate, not
prohibit, cutting edge scientific research.
The efforts of the global scientific community have made it
possible to create cells with the DNA of patients to be treated, using
unfertilized eggs and a scientific technique called ``nuclear
transplantation.'' Nuclear transplant research may be the key to
helping scientists understand why cells malfunction and how to
deprogram and reprogram these cells to function normally.
The Senate is considering whether to make the conduct of promising
nuclear transplant research a federal criminal offense. Opponents of
nuclear transplant research chide patients and parents not to be
hoodwinked by the biotechnology industry, which they warn is promoting
scientific research for financial gain. Patients and their families are
not naive; they are listening to scientists, not salesmen. Opponents
further admonish the scientific community not to raise the hopes of
sick children and adults and their families now, when a cure may be far
away. Many families have seen hereditary conditions ravage their loved
ones for generations. These families don't need the government to
protect them from hope, and they deserve access to the best medical
treatment that we all hope will result from future research.
I am not a scientist--I have not even played the part of a
scientist--but I know that overwhelmingly the brightest minds in
science throughout the world believe that this research is not only
promising, but that stem cell research and nuclear transplantation
represent a new frontier in medicine and potentially a giant step in
the history of man's continued triumph in the quest to ease human
suffering.
I believe there is no moral high ground in letting people suffer
and die in staggering numbers because of a fear of something that no
one wants: human reproductive cloning. The government can and should
ban human reproductive cloning.
I think, in fact, we have a great moral obligation to pursue this
new scientific research. In America we have the best and brightest
medical minds in the world. If we do not allow them to save lives and
diminish suffering--if we criminalize those who have dedicated their
lives to our health--if we allow millions of people to die every year
because we fear science--then we have not taken the moral high ground.
For our government to criminalize nuclear transplant research would be
a crime.
Senator Specter. Thank you very much, Mr. Kline.
Dr. Fischbach, on the issue of the effectiveness of nuclear
cell transplant and the studies conducted by Dr. Rudolph
Jaenisch, what is your evaluation of the tests showing that
therapeutic cloning works?
Dr. Fischbach. I think that paper, which just appeared a
few days ago, was extraordinary. I had a chance to look at it
quickly. The big news from that paper is that it does work. The
fact that there may still be residual problems with immune
rejection was considered a minor issue in that paper, one to be
paid attention to and explored further. Unexpected. But the
major point in that paper is that nuclear transfer, coupled
with genetic engineering of the stem cells so derived, could
reverse a devastating disorder of immune deficiency in these
model organisms. It holds great promise, enormous promise for
application to human disorders of immune deficiency.
The residual problem of the rejection of the cells
eventually may have several explanations. The cells were grown
in tissue culture for a while. There may be some other
modification. And that points out the need for more extensive
research on the stem cells. But the paper, as it stands, is a
great tribute to the promise of somatic cell nuclear transfer.
Senator Specter. Dr. Itescu, are you familiar with that
paper and able to give us your judgment on it?
Dr. Itescu. Yes. I would agree that the scientists were
clearly able to reverse the genetic defect through gene repair
in the embryonic stem cells and demonstrated the ability of the
embryonic stem cells, even after cloning, to be functionally
capable of regenerating the defect.
However, the problem about the rejection is a serious
problem. It is an example that there are many hurdles that need
to be overcome in using cloned cells in the recipient.
Senator Specter. What hurdles are those, Dr. Itescu?
Dr. Itescu. The underlying concept that a cloned cell will
not be rejected by the recipient I think has to at least be
challenged by these results, and I think there are many
possible explanations, including the fact that----
Senator Specter. So, those hurdles are challenged by the
results of the study that Dr. Fischbach and you were testifying
about?
Dr. Itescu. I think that there are hurdles that have been
raised through the results of this paper, and I think it
emphasizes why research needs to be done, needs to go forward
in many animal models because there will be surprising hurdles
that will come up. I think it emphasizes how much more support
this type of research requires prior to jumping into the
clinical arena.
Senator Specter. But you do favor additional research.
Dr. Itescu. Absolutely.
Senator Specter. And you would oppose criminal penalties
for the researchers who move into the area of nuclear
transplantation, or so-called therapeutic cloning?
Dr. Itescu. I would oppose criminalization of the
researchers.
Senator Specter. Do you think it might drive people back to
Australia?
Dr. Itescu. I think so.
Senator Specter. Do they have any criminal laws on this
subject in Australia?
Dr. Itescu. I think the debate is still ongoing in
Australia regarding this area.
Senator Specter. You say there is debate?
Dr. Itescu. There is currently debate on the same issues.
Senator Specter. The same as here. But they have not
criminalized it.
Dr. Itescu. No.
Senator Specter. Dr. Fischbach, what do you think would be
the consequence of legislation being passed which criminalized
this kind of research? Would we have an exodus of any
significant proportion?
Dr. Fischbach. I think there will be an exodus of
scientists, but it will extend even beyond that. I think it
will cast a pall over scientific research over a broad area. It
will be the first time ever that inquiry has been subject to
criminal penalties of this sort. So, I believe that it will
stop stem cell research. It will not stop it cold, but it will
severely limit it. It will be discouraging for senior and
junior scientists to continue in this field, and I think those
absolutely committed will emigrate where they can do the work.
But this is leaving family, friends, and institutions, and it
will cause great havoc I believe in the institutions.
Senator Specter. Dr. Fischbach, you represent a coalition
of some 60 universities. It is really important that there be a
massive effort by those universities to contact Senators. The
most effective way to have the influence is to contact Senators
in their States. We can provide you a list.
Tennessee is high on the agenda with Dr. Bill Frist who
made some comments in a hearing held last year before the
Health, Education, and Pension Committee where I testified. Dr.
Frist is our sole doctor Senator, so he has somewhat more
weight on the subject. And I only use Senator Frist
illustratively, but there needs to be that kind of activity.
We are writing to the editorial boards of the newspapers in
America and the talk shows to develop a public awareness. The
bill passed, as you heard, by 260-some votes to 160 in the
House, but they only had an hour and 10 minutes of debate. I
believe that with the unlimited debate we have in the Senate,
we can focus a bit more attention. But the proponents of
keeping the hands of scientists untied are going to have to
really work hard to join those of us on this issue who are in
favor of scientific freedom.
Mr. Kline, as an actor, you enjoy a profession which is
widely recognized. I do not see one camera focused on Dr.
Fischbach in this room at the moment.
Not one camera focused on Dr. Itescu at the moment.
Dr. Fischbach. I am used to it.
Senator Specter. Well, you are going to have to become an
orator of sorts, perhaps not an actor, Dr. Fischbach, but you
are going to have to make your voice heard in many, many places
through your coalition.
But, Mr. Kline, what would your suggestion be? This is not
your direct field of public persuasion, yet you influence a lot
of people with what you say. Would you have any suggestions as
to how we might carry on this campaign, and use the public
interest in all of the personalities you portray, to make them
aware of the importance of not tying scientists' hands and
allowing medical research to go forward?
Mr. Kline. I think clarity is what the American people
would relish, to understand, A, what we do know about stem cell
research and to understand that there is this enormous gray
area that we do not understand. Many of us in the lay community
are talking about these things that we really only know the tip
of the iceberg about. I think as such, whether we are Senators,
Congressmen, actors, lobbyists, it must all be taken into
account that perspective and with a grain of salt. We do not
know what it is.
My argument is that how can we close that door, how can we
not go down that road to find out what lies ahead with this
research? How can we, in fact, criminalize it? It is medieval
to me. I think if we just admit what we do know and admit what
we do not know--and what constitutes life is, as you said
earlier, a subject of great personal, private introspection,
and it is something between the individual and his god. I do
not know that we can legislate as either a governmental agency
or as a scientific agency or as a religious agency. Every
religion is going to have their own definition of what
constitutes human life. It is a very murky subject.
I think it comes down to a matter of compassion for life
that is being lived, life in progress that is afflicted with a
mortal disease with a heretofore unknown cure. It is weighing
that against the potential of what may or may not be a form of
human life.
Senator Specter. Well, we are facing a very difficult
situation. We are facing a bill which has been passed in the
House and that the President will sign. What we need to do is
focus public attention on it, and we need a national debate on
the subject. We need people to act in a representative
democracy--that is what we have, a republic, a representative
democracy--to contact their legislators and express their
opinions. If the Brownback bill wins, so be it, it wins, in a
democracy. But there ought to be a maximum effort to acquaint
the public with the situation so that we have that debate and
we have a rational decision, and if we do that, I believe that
nuclear transplants will prevail and scientists will not have
their hands tied.
Senator Mack's illustration on the fire could be
duplicated--in the 19th century when the House of Commons
passed a resolution saying that electricity and Edison's
efforts could never replace gas. And when Galileo went to jail
for supporting Copernicus that the earth was not flat. The
church took a position against dissecting cadavers in the 13th
century which set back medical research 300 years. The Scottish
church opined against the use of anesthesia in the 18th
century, saying that it was natural for women to endure pain
during childbirth. Those are but a few of the examples of
legislators, politicians tying the hands of scientists.
So if, in your world, Mr. Kline, you know any television
shows which are writing scripts in the next couple of weeks to
carry this message. I have already given Dr. Fischbach his
charge of moving ahead. And, Dr. Itescu, we want to keep you
here. We do not want you going back to Australia.
So, join us in this effort to have a rational judgment made
on this question so as not to have a brain drain, and not to
have the hands of scientists tied, and not to undercut the
tremendous opportunities we have with stem cells.
For the record, we are going to include a statement by the
Union of Orthodox Jewish Congregations, representing nearly
1,000 congregations and the Rabbinical Council of America whose
membership consists of more than 1,000 rabbis. I would ask that
the joint statement entitled ``Cloning Research: Jewish
Traditions and Public Policy'' be placed in the record, a
statement which supports nuclear transplant, so-called
therapeutic cloning, but opposes cloning for reproductive
purposes.
[The statement follows:]
Prepared Joint Statement of the Union of Orthodox Jewish Congregations
of America and the Rabbinical Council of America
cloning research, jewish tradition & public policy
Society today stands on the threshold of a new era in biomedical
research. The wisdom granted to humans by our Creator has led to our
greater understanding and knowledge of the building blocks of human
life itself. Scientists revealed the existence and role of DNA and
cellular science many years ago. Currently, scientists are not only
able to describe the nature of cellular life, but manipulate it as
well. We are now faced with the possibility of mastering the art of
this manipulation to the point of being able to clone in research
laboratories the cells that, in other circumstances, lead to fully
developed human beings.
A debate has emerged in American society at large and among our
elected leaders as to whether public policy should permit, encourage,
restrict or ban the further conduct of this biomedical research. The
issue is one with complex moral dimensions. On the one hand scientific
research indicates that there is great life-saving potential in the
results that can come from cloning research.\1\ On the other hand, we
must be vigilant against any erosion of the value that society accords
to human life.
---------------------------------------------------------------------------
\1\ This joint statement specifically addresses our view on the
subject of cloning technology research. We have previously set forth
our views on the related subject of stem cell research in a document
which may be found at http://www.ou.org/public/Publib/cloning.htm
---------------------------------------------------------------------------
Our Torah tradition places great value upon human life; we are
taught in the opening chapters of Genesis that each human was created
in God's image. After creating man and woman, God empowered them to
enter a partnership with Him in the stewardship of the world. The Torah
commands us to treat and cure the ill and to defeat disease wherever
possible; to do this is to be the Creator's partner in safeguarding the
created. The traditional Jewish perspective thus emphasizes that
maximizing the potential to save and heal human lives is an integral
part of valuing human life. Moreover, our tradition states that an
embryo in vitro does not enjoy the full status of human-hood and its
attendant protections. Thus, if cloning technology research advances
our ability to heal humans with greater success, it ought to be pursued
since it does not require or encourage the destruction of life in the
process.
However, cloning research must not be pursued indiscriminately. We
must be careful to distinguish between cloning for therapeutic
purposes--which ought to be pursued, and cloning for reproductive
purposes--which we oppose. Thus, this research must be conducted under
strict guidelines and with strict limitations to ensure that the
research is indeed serving therapeutic purposes.
Consistent with this policy, we advocate that a fully funded and
empowered oversight body comprised of scientists and ethicists be
created to monitor this research. Relevant Executive-branch agencies
and congressional committees should conduct periodic reviews as well.
The oversight process should pay special attention to ensuring that the
embryos used in this research are not brought to a point which
constitutes human-hood.
We believe that the policy stated herein articulates the
perspective of the Torah tradition and the community we represent and
achieves the correct balance between pursuing new methods for saving
human lives and maintaining the fundamental respect and sanctity of
human life.
CONCLUSION OF HEARINGS
Senator Specter. Thank you all very much for being here,
that concludes our hearings.
[Whereupon, at 3:25 p.m., Tuesday, March 12, the hearings
were concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]