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[Senate Hearing 107-541]
[From the U.S. Government Publishing Office]

                                                        S. Hrg. 107-541
 
                             CLONING, 2002
=======================================================================

                                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

 Available via the World Wide Web: http://www.access.gpo.gov/congress/
                                 senate
                                 ______

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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
                                 ------                                

 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

                              ----------                              

                       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

                              ----------                              

                       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.
---------------------------------------------------------------------------
    * 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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
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    \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
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    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.]

                             
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