```

[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]

 THE HUMAN CLONING PROHIBITION ACT OF 2001 AND THE CLONING PROHIBITION 
                              ACT OF 2001

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

                                HEARING

                               before the

                         SUBCOMMITTEE ON HEALTH

                                 of the

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED SEVENTH CONGRESS

                             FIRST SESSION

                                   on

                        H.R. 1644 and H.R. 2172

                               __________

                             JUNE 20, 2001

                               __________

                           Serial No. 107-41

                               __________

       Printed for the use of the Committee on Energy and Commerce

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

                               __________

                   U.S. GOVERNMENT PRINTING OFFICE
73-733                     WASHINGTON : 2001

_______________________________________________________________________
 For sale by the Superintendent of Documents, U.S. Government Printing 
                                 Office
Internet: bookstore.gpo.gov  Phone: (202) 512-1800  Fax: (202) 512-2250
               Mail: Stop SSOP, Washington, DC 20402-0001
                    ------------------------------  

                    COMMITTEE ON ENERGY AND COMMERCE

               W.J. ``BILLY'' TAUZIN, Louisiana, Chairman

MICHAEL BILIRAKIS, Florida           JOHN D. DINGELL, Michigan
JOE BARTON, Texas                    HENRY A. WAXMAN, California
FRED UPTON, Michigan                 EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida               RALPH M. HALL, Texas
PAUL E. GILLMOR, Ohio                RICK BOUCHER, Virginia
JAMES C. GREENWOOD, Pennsylvania     EDOLPHUS TOWNS, New York
CHRISTOPHER COX, California          FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia                 SHERROD BROWN, Ohio
STEVE LARGENT, Oklahoma              BART GORDON, Tennessee
RICHARD BURR, North Carolina         PETER DEUTSCH, Florida
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
GREG GANSKE, Iowa                    ANNA G. ESHOO, California
CHARLIE NORWOOD, Georgia             BART STUPAK, Michigan
BARBARA CUBIN, Wyoming               ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois               TOM SAWYER, Ohio
HEATHER WILSON, New Mexico           ALBERT R. WYNN, Maryland
JOHN B. SHADEGG, Arizona             GENE GREEN, Texas
CHARLES ``CHIP'' PICKERING,          KAREN McCARTHY, Missouri
Mississippi                          TED STRICKLAND, Ohio
VITO FOSSELLA, New York              DIANA DeGETTE, Colorado
ROY BLUNT, Missouri                  THOMAS M. BARRETT, Wisconsin
TOM DAVIS, Virginia                  BILL LUTHER, Minnesota
ED BRYANT, Tennessee                 LOIS CAPPS, California
ROBERT L. EHRLICH, Jr., Maryland     MICHAEL F. DOYLE, Pennsylvania
STEVE BUYER, Indiana                 CHRISTOPHER JOHN, Louisiana
GEORGE RADANOVICH, California        JANE HARMAN, California
CHARLES F. BASS, New Hampshire
JOSEPH R. PITTS, Pennsylvania
MARY BONO, California
GREG WALDEN, Oregon
LEE TERRY, Nebraska

                  David V. Marventano, Staff Director

                   James D. Barnette, General Counsel

      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

                         Subcommittee on Health

                  MICHAEL BILIRAKIS, Florida, Chairman

JOE BARTON, Texas                    SHERROD BROWN, Ohio
FRED UPTON, Michigan                 HENRY A. WAXMAN, California
JAMES C. GREENWOOD, Pennsylvania     TED STRICKLAND, Ohio
NATHAN DEAL, Georgia                 THOMAS M. BARRETT, Wisconsin
RICHARD BURR, North Carolina         LOIS CAPPS, California
ED WHITFIELD, Kentucky               RALPH M. HALL, Texas
GREG GANSKE, Iowa                    EDOLPHUS TOWNS, New York
CHARLIE NORWOOD, Georgia             FRANK PALLONE, Jr., New Jersey
  Vice Chairman                      PETER DEUTSCH, Florida
BARBARA CUBIN, Wyoming               ANNA G. ESHOO, California
HEATHER WILSON, New Mexico           BART STUPAK, Michigan
JOHN B. SHADEGG, Arizona             ELIOT L. ENGEL, New York
CHARLES ``CHIP'' PICKERING,          ALBERT R. WYNN, Maryland
Mississippi                          GENE GREEN, Texas
ED BRYANT, Tennessee                 JOHN D. DINGELL, Michigan,
ROBERT L. EHRLICH, Jr., Maryland       (Ex Officio)
STEVE BUYER, Indiana
JOSEPH R. PITTS, Pennsylvania
W.J. ``BILLY'' TAUZIN, Louisiana
  (Ex Officio)

                                  (ii)

                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Allen, Hon. Claude A., Deputy Secretary, Department of Health 
      and Human Services.........................................    20
    Doerflinger, Richard M., Associate Director for Policy 
      Development, National Conference of Catholic Bishops.......    78
    Fukuyama, Francis, Omer L. and Nancy Hirst Professor of 
      Public Policy, School of Public Policy, George Mason 
      University.................................................    87
    Guenin, Louis M., Lecturer on Ethics in Science, Department 
      of Microbiology and Molecular Genetics, Harvard Medical 
      School.....................................................    55
    Kass, Leon R., Addie Clark Harding Professor of Social 
      Thought and the College, University of Chicago.............    50
    Newman, Stuart A., Professor of Cell Biology and Anatomy, 
      Department of Cell Biology and Anatomy, New York Medical 
      College....................................................    67
    Norsigian, Judy, Executive Director, Boston Women's Health 
      Book Collective, Boston University School of Public Health.    76
    Okarma, Thomas, President, Geron Corporation, on Behalf of 
      Biotechnology Industry Organization........................    45
    Perry, Daniel, Executive Director, Alliance for Aging 
      Research...................................................    72

                                 (iii)

  

 
 THE HUMAN CLONING PROHIBITION ACT OF 2001 AND THE CLONING PROHIBITION 
                              ACT OF 2001

                              ----------                              

                        WEDNESDAY, JUNE 20, 2001

                  House of Representatives,
                  Committee on Energy and Commerce,
                                    Subcommittee on Health,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10:15 a.m., in 
room 2123, Rayburn House Office Building, Hon. Michael 
Bilirakis (chairman) presiding.
    Members present: Representatives Bilirakis, Greenwood, 
Burr, Ganske, Norwood, Cubin, Wilson, Shadegg, Bryant, Buyer, 
Pitts, Tauzin (ex officio), Brown, Waxman, Strickland, Barrett, 
Deutsch, Stupak, Engel, and Green.
    Also Present: Representatives Stearns and DeGette.
    Staff present: Marc Wheat, majority counsel; Brent Del 
Monte, majority counsel; Kristi Gillis, legislative clerk; and 
John Ford, minority counsel.
    Mr. Bilirakis. Come to order. The Chair apologizes for his 
tardiness, and this hearing will come to order. I want to thank 
our witnesses for their time and effort in joining us today for 
this very important hearing.
    Today, the Subcommittee on Health will continue where the 
Subcommittee on Oversight and Investigations, chaired by 
Congressman Gene Greenwood, left off. We will examine two 
measures, which, in many ways, reflect the discussions of that 
hearing: H.R. 1644, sponsored by Congressmen Weldon and Stupak, 
and H.R. 2172, sponsored by Congressmen Greenwood and Deutsch.
    This is a difficult issue, to say the least, and it 
involves many new and complex concepts. But we should all be 
clear, I think, about the controversies related to human 
cloning. The term ``therapeutic cloning,'' which many people 
use to mean any type of cloning that is not intended to result 
in a pregnancy, is confusing.
    It really includes two, distinct procedures, one of which 
is controversial, while the other, I think, is not. The non-
controversial concept of therapeutic cloning is the cloning of 
human tissue that does not give rise to an embryo.
    The controversial aspect involves the creation of a human 
embryo. This latter meaning is also the subject of both of the 
bills we will discuss today.
    H.R. 1644 seeks to ban the creation of these cloned human 
embryos. H.R. 2172 seeks to prevent those who clone human 
embryos from implanting them in a surrogate mother.
    What are we to make of the discussion today? Some patient 
groups want cloned embryos to be created because their tissue 
may prove to be valuable in biomedical research. Some companies 
would like to clone human embryos because it will lead to a 
cheaper way to manufacture tissue.
    Writing in 1947, C.S. Lewis observed in ``The Abolition of 
Man'' that man's conquest of nature would be complete when he 
finally, and I quote him because I think this kind of says it, 
``has obtained full control over himself. Human nature will be 
the last part of nature to surrender to man. The battle will 
then be won. We shall have taken the threat of life out of the 
hand of Cloe, and be henceforth free to make our species 
whatever we wish it to be. The battle will, indeed, be won. But 
who, precisely, would have won it? For the power of man to make 
himself what he pleases means, as we have seen, the power of 
some men to make other men what they please.''
    Human cloning rises to the most essential question of who 
we are and what we might become if we open this Pandora's box. 
I look forward to the testimony of our witnesses who will help 
us understand just what might be in that box.
    The Chair now yields to Mr. Brown.
    Mr. Brown. Thank you very much, Mr. Chairman, and thank you 
for calling this hearing. I want to thank our witnesses, Mr. 
Allen especially, for testifying before us. I also want to 
thank my colleagues, Mr. Deutsch and Mr. Greenwood, Ms. 
DeGette, Mr. Stupak, and Mr. Weldon for their tireless work on 
this extraordinarily complicated issue.
    The issue today is not about whether to ban the cloning of 
a human being, but how to ban cloning in a way that--that best 
serves society. Cloning grabbed the spotlight in 1997, as we 
know, with the cloning of the sheep Dolly in Scotland.
    This remarkable breakthrough in science was followed by 
public scrutiny and largely fear. How far away was the science 
to clone humans?
    President Clinton and the Congress responded immediately. 
The President issued a memorandum to the heads of all executive 
departments and agencies, making it clear that no Federal funds 
would be used for cloning.
    Several bills were introduced banning human cloning 
research and banning human cloning altogether.
    And now, 4 years after scientists developed Dolly, Congress 
has remained divided on what we think is the most appropriate 
way to ban the cloning of humans.
    I want to first thank Mr. Stupak, my colleague, for his 
work on this issue. While I may not favor his approach, I 
respect his views on this difficult topic.
    Congressman Deutsch and Congressman Greenwood have 
introduced legislation that I believe is a responsible approach 
to banning cloning without restricting promising research. Like 
the Weldon-Stupak bill, the Greenwood-Deutsch bill bans human 
somatic cell nuclear transfer, the technique used for cloning, 
with the intent to initiate a pregnancy.
    But in regards to the scope of this bill, their bill 
protects all other types of cloning, including therapeutic 
embryo cloning.
    As the biotech industry will attest to, we are dramatically 
close to providing cures and treatment for a wide variety of 
illnesses, such as Parkinson's, and Alzheimers, and spinal cord 
injury, and heart disease, and diabetes, and kidney disease, 
and stroke.
    Additionally, with the type--this type of research, it is 
possible, medical researchers and scientists tell us, that we 
could virtually eliminate the need for organ transplants and 
toxic immuno-suppressive drugs.
    In terms of preventing human cloning, banning all science 
related to human cloning is no more effective than banning the 
act of human cloning itself. It would be irresponsible of this 
Congress, I believe, to stifle promising medical research under 
the auspices of banning human cloning.
    What is at risk if we close the door to this type of 
research? The ability to regenerate a failing organ, rather 
than waiting for a transplant and then hoping the body won't 
reject that organ? The ability to stop the onset of juvenile 
diabetes so a young child doesn't have to endure injections 3, 
4, 5 times a day? The ability to restore the nervous system for 
an accident victim left paralyzed? The ability to reverse forms 
of muscular dystrophy which rob children of full mobility and, 
all to often, tragically, rob them of their adulthood?
    Too much is at risk to stop the research before its 
potential is fully understood. Thank you, Mr. Chairman.
    Mr. Bilirakis. And I thank the gentleman. And I would ask 
the members to try to limit their opening statements to as 
close to 3 minutes as they possibly can. Mr. Stearns for an 
opening statement? You do have seniority, you know?
    Mr. Stearns. Mr. Chairman, I bow to your wisdom, and 
seniority, and good sense, and I appreciate the opportunity to 
give my opening statement. I introduced in the 105th and 106th 
Congress my own legislation to prohibit Federal funding for the 
cloning of human beings.
    The bill I introduced is H.R. 1372, and it also calls for 
an international ban on human cloning. I am also a co-sponsor 
of H.R. 1644, introduced by my colleague, Mr. Weldon and Mr. 
Stupak of Michigan.
    The quotation you used for C.S. Lewis, ``Abolition of 
Man,'' is terrific. I don't know if you have read that book, 
but that book sums up what we are here talking about. C.S. 
Lewis was on the leading edge of understanding human rights and 
the relationship to human beings and his Maker.
    Cloning is a form of playing God since it interferes with 
the natural order of creation. We should be very cautious on 
how we address this issue. Besides the obvious moral 
implications, there are several other compelling reasons why we 
should not be cloning human beings.
    By far, however, the most compelling is that man lacks the 
ability to predict or control the possible consequences of 
cloning. The Boys from Brazil, do you remember that movie? That 
movie would no longer be fiction. We are actually living in a 
world where the cloning of human beings is a very real 
possibility.
    Ever since the world was made aware of Dolly and then the 
infamous Dr. Seed and the possibility of cloning human beings, 
significant actions have been taken to outlaw this practice.
    As we all know, former President Clinton called for a ban 
on the use of Federal funds for research on cloning of human 
beings, and President Bush supports a total ban on cloning, I 
believe legislation to ban Federal funding on human cloning is 
necessary. And the European Convention on Human Rights and Bio-
Medicine, covering not just the European Union, but all 
European states, has already outlawed this practice.
    Currently in the United States, four States prohibit 
cloning, and eight more States have legislation pending to ban 
human cloning.
    Let us take a look, my friends, at the California law. It 
imposes a 5-year moratorium on cloning of an entire human 
being. The word ``entire'' is key because some of us consider 
an embryo to be a human being.
    That is why we must be very cautious in the terminology 
that is used because you will hear the words, not for 
reproductive purposes, being used frequently in debates about 
cloning. That is just one of the many problems associated with 
technology that may be used to close humans.
    At least seven States have bans to prohibit transferring 
the nuclei from a human cell and a human egg. But that doesn't 
address the possibility of transferring a human nucleus into a 
non-human egg. But that is not the only loophole.
    Seven States' proposals ban the creation of genetically 
identical individuals, but that leaves another loophole. An egg 
cell, donated for cloning, has its own mytochondrial DNA, which 
is different from the mytochondrial DNA of the cell that 
provided the nucleus. The clone will, therefore, not truly be 
identical.
    There are many issues raised by the possibility of cloning 
humans, including the medical risks that are inherent in such 
procedures. These risks should cause great alarm for each of us 
this morning.
    In 1998, the Farm Animal Welfare Council of the United 
Kingdom Minister of Agriculture called for a moratorium on 
commercial uses of animal cloning because of serious welfare 
problems encountered when animal species have been cloned.
    So, to attempt such a technique on humans, which has caused 
deformities, large fetuses, and premature deaths in sheep and 
cattle is not being responsible.
    Let us not forget that it took 273 tries to develop a 
Dolly. That begs a question: what about the other 272 animals? 
Most of them were either aborted, destroyed, or maimed. 
Obviously, we do not want to do this to human beings.
    There are also compelling and serious ethical and moral 
implications involved with the cloning of humans. Theologians--
theologians and ethicists have raised three broad objections. 
Cloning humans could lead to a new eugenics movement where, 
even if cloning begins with a benign purpose, it could lead to 
the establishment of scientific categories of superior and 
inferior people.
    Cloning is a form of playing God since it interferes with 
the natural order of creation, and cloning could have long-term 
effects that are unknown at this time.
    Mr. Bilirakis. Would the gentleman finish up? The time has 
expired.
    Mr. Stearns. People have a right to their own identity and 
their own genetic make-up. And so, Mr. Chairman, I look forward 
to our distinguished panels and hearing their answers.
    [The prepared statement of Hon. Cliff Stearns follows:]
Prepared Statement of Hon. Cliff Stearns, a Representative in Congress 
                       from the State of Florida
    Thank you, Chairman Bilirakis, for holding this important hearing 
on legislation to ban the cloning of human beings.
    Because I felt so strongly about this issue I introduced 
legislation in the 105th and 106th Congresses to prohibit federal 
funding for the cloning of human beings. I reintroduced this 
legislation in this Congress. The bill is H.R. 1372 and also calls for 
an international ban on human cloning. I am also a cosponsor of H.R. 
1644, introduced by my colleague from Florida, Mr. Weldon and Mr. 
Stupak of Michigan.
    Cloning is a form of playing God since it interferes with the 
natural order of creation. We should be very cautious in how we address 
this issue. Besides the obvious moral implications, there are several 
other compelling reasons why we should not be cloning humans. By far, 
however, the most compelling is that man lacks the ability to predict 
or control the possible consequences of cloning.
    The Boys from Brazil is no longer fiction. We are actually living 
in a world where the cloning of humans is a possibility.
    Ever since the world was made aware of Dolly, and then the infamous 
Dr. Seed and the possibility of cloning human beings, significant 
actions have been taken to outlaw this practice.
    As we all know, former President Clinton issued a memorandum 
calling for a ban on the use of federal funds for research on cloning 
of human beings and the European Convention on Human Rights and 
Biomedicine, covering not just the EU, but all European states has 
already outlawed this practice.
    President Bush and Secretary Thompson oppose the use of human 
somatic cell nuclear transfer either for reproductive purposes or for 
therapeutic purposes.
    Even though President Clinton called for the prohibition of federal 
funds for cloning of human beings and President Bush supports a total 
ban on human cloning, I believe legislation to ban federal funding of 
research on humans is necessary.
    Currently, in the United States four states prohibit cloning and 
eight more states have legislation pending to ban human cloning.
    Let's take a look at the California law. It imposes a five-year 
moratorium on cloning of an entire human being. The word entire is key 
because some of us consider an embryo to be a human being. That is why 
we must be very cautious in the terminology that is used because you 
will hear the words not for reproductive purposes being used frequently 
in debates about cloning. That is just one of many problems associated 
with technology that may be used to clone humans.
    At least seven states have bans to prohibit transferring the 
nucleus from a human cell into a human egg, but that doesn't address 
the possibility of transferring a human nucleus into a ``nonhuman 
egg.''
    But, that is not the only loophole. Seven state proposals ban the 
creation of ``genetically identical'' individuals, but that leaves 
another loophole. ``An egg cell donated for cloning has its own 
mitochondrial DNA, which is different from the mitrochondrial DNA of 
the cell that provided the nucleus. The `clone' will therefore not be 
truly identical.''
    There are many issues raised by the possibility of cloning humans, 
including the medical risks that are inherent in such procedures. These 
risks should cause great alarm for each and every one of us. In 1998 
the Farm Animal Welfare Council of the UK Minister of Agriculture 
called for a moratorium on commercial uses of animal cloning because of 
serious welfare problems encountered when animal species have been 
cloned. So, to attempt such a technique on humans, which has caused 
deformities, large fetuses and premature deaths in sheep and cattle is 
the height of irresponsibility.
    Let's not forget that it took 273 tries to develop Dolly. That begs 
the question, what about the other 272 animals? Most of them were 
either aborted. destroyed, or maimed. Obviously, we do not want to do 
this with human beings.
    There are also compelling and serious ethical and moral 
implications involved with cloning of humans. Theologians and ethicists 
have raised three broad objections. Cloning humans could lead to a new 
eugenics movement, where even if cloning begins with a benign purpose, 
it could lead to the establishment of ``scientific'' categories of 
superior and inferior people. Cloning is a form of playing God since it 
interferes with the natural order of creation. Cloning could have long-
term effects that are unknown and harmful. People have a right to their 
own identity and their own genetic makeup, which should not be 
replicated.
    I look forward to hearing from our distinguished panel of witnesses 
about this complex and compelling problem.

    Mr. Bilirakis. The Chair recognizes Mr. Waxman for an 
opening statement.
    Mr. Waxman. Thank you, Mr. Chairman. Today's hearing--
hearing involves research that holds a great deal of promise 
for defeating disease and repairing damaged organs.
    The hearing also involves a great deal of confusion, much 
of it spilling over from the ongoing political debate about 
abortion. I hope the hearing--I hope that the hearing can 
further the research and clear up the confusion.
    Let me start that effort by clarifying what we mean by 
cloning research, because the term means different things to 
different people. Some cloning research involves, for example, 
using genetic material to generate one adult skin cell from 
another adult skin cell. I know of no serious opposition to 
such research.
    Some cloning research starts with a human egg cell, inserts 
a donor complete genetic material into its core, and allows the 
egg cell to multiply to produce new cells genetically identical 
to the donor's cells. These cells can, in theory, be 
transplanted to be used for organ repair or tissue regeneration 
without risk of allergic reaction or rejection. There is 
controversy about this research, as we will hear today.
    Some cloning research starts with a human egg and donated 
genetic material, but is intended to go further in an effort to 
create what is essentially a human version of Dolly the sheep, 
a full-scale, living replica of the donor of the genetic 
material. I know of no serious support for such research.
    To keep things clear in discussion today, I will use 
different terms for these three different aspects of cloning 
research. The first widely supported field I refer to as tissue 
generation. And I understand that some people call it cell-line 
propagation.
    The second controversial field I will refer to as genetic 
cell replication. Other call--others call it therapeutic 
cloning.
    And the third unsupported field is widely known as 
reproductive cloning. In order to tilt the debate about genetic 
cell replication research, some opponents lump it with Dolly 
the sheep. No one benefits from such confusion.
    If some think research is good and others think it is 
wrong, that dispute should be aired clearly and not blurred by 
blending subjects or exaggerating claims. If a field of 
research is to be prohibited or allowed, we should do so on its 
merits.
    Some also argue to prohibit genetic cell replication 
research because it might, in the wrong hands, be turned into 
reproductive cloning research. I cannot support this argument.
    So a--such a prohibition is no more reasonable than to 
prohibit all clinical trials because researchers might give 
overdoses deliberately. It is as much overreaching as 
prohibiting all organ transplant studies because an 
unscrupulous person might buy or sell organs for profit.
    All research can be misused. That is why we regulate 
research, investigate abuse of subjects, and prosecute 
scientific fraud and misconduct.
    If researchers give drug overdoses in clinical trials, the 
law requires they be disbarred and punished. If someone were to 
traffic an organ, the law requires they be prosecuted. We 
should clearly define what we believe is wrongdoing, prohibit 
it, and enforce that prohibition.
    But we should not shut down beneficial work, clinical 
trials, organ transplants, or genetic cell replication because 
of a risk of wrongdoing.
    In closing, I want to acknowledge that principled people do 
differ in this area. Some believe that a fertilized egg, 
whether it is inside a womb or inside a test-tube, is the same 
as a human being.
    They are logically consistent when they oppose genetic cell 
replication. They are also logically opposed to abortion, to in 
vitro fertilization as it is generally practiced, and to some 
methods of family planning.
    I don't question their sincerity, but I sincerely do not 
agree with them. And I do not believe that the Congress should 
prohibit potentially lifesaving research on genetic cell 
replication because it accords a cell, a special cell, but only 
a cell, the same rights and protections as a person.
    I look forward to hearing from the witnesses today. Thank 
you very much for holding these hearings.
    Mr. Bilirakis. And I thank the gentleman. Mr. Greenwood for 
an opening statement?
    Mr. Greenwood. Thank you, Mr. Chairman, and I do 
particularly appreciate your holding this hearing. The humorist 
and social critic H.L. Mencken once wryly observed that, ``For 
every complex problem, there is a solution that is simple, 
neat, and wrong.''
    Today, this committee has before it two competing bills to 
outlaw the cloning of human beings. Mr. Weldon's bill, H.R. 
1644, while commendable in its intent, suffers from the weight 
of Mr. Menschen's observation.
    It is a simple and straightforward solution to a very 
complex matter of science, but it is, unfortunately, wrong. It 
seeks to ban all forms of cloning which involve the use of the 
cells of human beings.
    The measure which Mr. Deutsch and I--the measure which Mr. 
Deutsch and I have introduced, however, while perhaps failing 
the simplicity test, does confront the need to provide a 
sophisticated solution to a complex problem.
    The admonition we try to follow is the one which Einstein 
recommended: ``Everything should be made as simple as possible, 
but not simpler.''
    Esentially, our bill would seek to outlaw all attempts at 
reproductive human cloning, while permitting further and very 
carefully circumscribed research in the areas of somatic cell 
nuclear transfer, a process that holds out a very real promise 
of a new kind of therapy known as regenerative medicine.
    Briefly, this promising therapy would replace damaged or 
dead cells with healthy, and vigorous, new, and transplantable 
cells, thereby enabling physicians to treat millions of those 
who now suffer from chronic diseases, such as diabetes, stroke, 
heart disease, Parkinson's disease, and spinal cord injury.
    This is about allowing people who are in coma to open their 
eyes, and stand up, and return to their family. This is about 
allowing people who are paralyzed, quadriplegics, to walk 
again. That is what is at stake here.
    I have had an opportunity to review the written testimony 
of our distinguished panel of witnesses here today, and I 
believe it is fair to say that while all of them oppose 
reproductive cloning, not all are convinced that cloning 
research is without merit.
    Indeed, two of our scholars will testify that their support 
of Mr. Weldon's bill is more a matter of public policy; one 
might even say politics, rather than good science. Simply 
stated, it would appear that they do not think that 
reproductive cloning can be effectively banned once the 
research genie has been let out of the bottle.
    But that approach still begs the question I asked in my 
opening remarks at our first hearing on cloning earlier this 
year. The question this generation must ask is this: what 
should we do with this science? We must not only address the 
problems that come about from the use of the technology, but 
the foregone opportunities, cures for diseases, ailments, and 
illnesses that may be lost. Should we entirely ban this 
technology?
    And I reject the premise that we are unable to distinguish 
between the dangers of untrammeled scientific experiments on 
the one hand, and new paradigms in biomedical research on the 
other.
    We owe it to ourselves and our posterity to have more faith 
in our ability to guide and direct human conduct than this 
cramped approach would allow.
    One of our witnesses, though not himself a scientist, 
asserts that any form of research into therapeutic cloning is, 
``as morally abhorrent as it is medically questionable.''
    His objection is that embryonic cells are, in actuality, 
``new, living human beings.'' Even if we were to accept this 
premise, which I do not, what are we to make of in vitro 
fertilization? Each year, thousands, if not hundreds of 
thousands, of human embryos are discarded. Should this process, 
too, be outlawed? Shouldn't this practice also be construed as 
morally repugnant given the witness's definition?
    And make no mistake; in vitro fertilization is not free of 
very complex and difficult, moral, ethical, and legal 
controversies. Issues of third-party donations of sperm or 
eggs, surrogate mothers, embryo division, sex selection of 
children, genetic testing, and potential genetic engineering, 
even rights of ownership, all are present in this practice.
    But here, as one of our other witnesses recently pointed 
out, dogma is overcome by human desire. For while some clergy 
may condemn in vitro fertilization, 75 percent of the American 
people favor the practice as a means for a loving couple to 
bring a child into the world.
    Then, there is the reality of the old-fashioned method of 
reproduction that we call sex. It is simply not true in the 
human body that every time an egg and sperm are joined human 
life begins.
    On the contrary, quite frequently the embryo fails to 
attach to the uterine wall and is flushed out of a woman's 
body. What are we to make of this, when the largest loss of 
embryos is a result of the natural order of things human?
    Mr. Bilirakis. Would the gentleman please finish up? The 
time is----
    Mr. Greenwood. Mr. Chairman, I would ask unanimous consent 
for an additional 1 minute to complete my opening statement?
    Mr. Bilirakis. We are getting away from that 3-minute thing 
that I asked----
    Mr. Greenwood. Well, Mr. Chairman, since it is my bill, I 
wondered if I could just have this indulgence?
    Mr. Bilirakis. Without objection, it will----
    Mr. Greenwood. Thank you.
    Mr. Bilirakis. [continuing] be the case.
    Mr. Greenwood. In making this observation, I do not mean to 
be glib. On the contrary, I wish to admonish all of us that we 
should exercise great care when we make pronouncements about a 
mystery as deep as the creation of human life. The question 
about when life begins is too profound to be settled here 
today.
    And in any case, this is not what this hearing is about. 
And if we cannot all agree on when life begins, we can all of 
us: Christian, Muslin, and Jew agree to this, I think, that 
every child is a new idea in the mind of God, and that this is 
now, and will be forever, the essence of humanity.
    Using this definition, human clones would be replicates, 
the human equivalent of an epilogue. This is where I choose to 
draw the line. I oppose it; it must be outlawed.
    And where there is a risk of some morally bankrupt 
charlatan pursuing reproductive cloning, we must make it 
abundantly clear that that man or woman is a pariah, even as we 
embrace the child who may be born of such an effort.
    But make no mistake; the wistful hope of some of today's 
witnesses that in outlawing every aspect of cloning, we will 
somehow eliminate attempts to accomplish human cloning is a 
little more than whistling in the dark.
    And I hope that they will forgive me when I observe that by 
embracing a universal ban on cloning, it is they who would be 
guilty of throwing the baby out with the bath.
    The philosopher Arthur Schopenhaeur observed that, ``All 
truth passes through three stages. First, it is ridiculed. 
Second, it is violently opposed. Third, it is accepted as being 
self-evident.''
    I believe that this is precisely what occurred in the case 
of in vitro fertilization, and I believe we will look back upon 
this hearing today and recall that the same was true of the 
remarkable medical breakthroughs made possible by therapeutic 
cloning.
    In 1846 when the Scottish physician, James Simpson, urged 
the use of chloroform to reduce the----
    Mr. Bilirakis. Mr. Greenwood, I am sorry, but you are 2 
minutes over, sir.
    Mr. Greenwood. Very well.
    Mr. Bilirakis. Mr. Deutsch for an opening statement?
    Mr. Deutsch. Thank you, Mr. Chairman. I would ask the 
members of the that they would accept my written statement in 
full into the record.
    Mr. Bilirakis. Without objection, that will be the case for 
every member of the subcommittee.
    Mr. Deutsch. I would like the chairman and ranking member 
for holding a second hearing on this important and complex 
subject. I understand that this is a powerful issue with many 
points of view to be heard and discussed.
    I hope that members listen carefully to the testimony of 
our witnesses, and use this opportunity to better understand 
the scientific and ethical issues surrounding human cloning.
    Our actions today when proceed with these bills will have a 
profound effect on the future of scientific discovery and the 
health and welfare of our constituents. We have a 
responsibility to proceed in a thoughtful and considerate 
manner that acknowledges the future benefits of scientific 
research, while accepting and protecting against the current 
flaws in the cloning process.
    Mr. Chairman, I believe it is fair to say that no one 
sitting on this stage thinks we should allow reproductive 
cloning at this point in time. The process has clearly been 
shown to be imprecise and dangerous. Of the animals that have 
been cloned to date, none have been free of abnormalities.
    The great majority of cloned animals die at birth or soon 
after. Those that survive often suffer from kidney, brain, or 
immune system abnormalities. Even Dolly the sheep, successfully 
cloned only after more than 270 attempts, suffered some severe 
obesity.
    With these apparent risks, though highly prevalent in 
animals, it is imperative that we ban reproductive cloning and 
that we devote appropriate resources to upholding this ban.
    That being said, it is clear there are significant benefits 
to be derived from therapeutic cloning, as several of our 
witnesses will testify. Since our last hearing on the subject 
in March, I have worked closely with Congressman Greenwood to 
develop legislation that we believe protects the public from 
the precarious and uncertain nature of reproductive cloning, 
while preserving promising biomedical research.
    Specifically, the Greenwood-Deutsch legislation bans the 
use of human somatic cell and nuclear transfer with the intent 
to initiate a pregnancy, and imposes severe criminal and civil 
sanctions on any person or company that breaks this law. This 
language is the guts and substance of our legislation.
    However, we have purposefully drawn a bright line in the 
bill between reproductive cloning and therapeutic cloning. Our 
legislation specifically protects the use of human somatic cell 
nuclear transfer to clone molecules, DNA, cells, or tissues.
    This is one of the most promising areas of research for 
diseases like Alzheimers, Parkinson's, and diabetics--diabetes, 
just to name a few.
    To ban therapeutic cloning, as the Weldon-Stupak 
legislation does, would be a travesty for the millions of 
people in our country whose lives are affected on a daily basis 
by these devastating conditions.
    I won't go into detail of the myriad of cures and 
treatments that therapeutic cloning could provide, as Dr. 
Okarma and Mr. Perry will more than adequately make this point 
with their testimony.
    I only emphasize the importance of understanding the clear 
distinction between reproductive cloning, which we need to 
unequivocally ban, and therapeutic--therapeutic cloning, which 
we unequivocally need to protect.
    As we have moved toward this hearing, there have been 
questions raised by supporters of the Weldon-Stupak bill about 
the ability of our bill to effectively eliminate reproductive 
cloning without banning the creation of cloned embryos.
    Let me state now that I am committing to working to tighten 
and amend the legislation to ensure it fits our intended policy 
objectives. However, I believe there are inherent flaws in the 
logic of some of these issues that were raised with the 
Greenwood-Deutsch legislation.
    For instance, a recent ``Dear Colleague'' issued by Dr. 
Weldon implies there is no way to enforce a ban on transferring 
a cloned embryo to a woman's uterus if there is no ban on 
creating those embryos. My response to Dr. Weldon's concern is, 
how will you enforce your ban on creating cloned embryos?
    One benefit of the Greenwood-Deutsch legislation is that it 
prospectively addressees the enforcement issue by requiring all 
entities that plan on performing human somatic cell nuclear 
transfer to register with the FDA.
    That registration will contain an attestment they are aware 
of the prohibition on reproductive cloning and will not engage 
in any violation of that prohibition.
    Additionally, by specifically stating in the legislation 
that it is a crime to intend to use human somatic cell nuclear 
transfer to initiate a pregnancy, our bill allows the FDA to 
intervene in a potential reproductive cloning scenario even 
prior to the creation of a cloned embryo. The Weldon-Stupak 
legislation forces the FDA to delay intervention until an 
embryo has been cloned.
    I would like to address one final issue before I wrap up my 
statement. One of those issues that neither bill addresses is 
that--the products derived from therapeutic cloning.
    If the Weldon-Stupak legislation passes and therapeutic 
cloning is banned in the United States, there is no doubt that 
bio-tech companies will simply move off-shore and continue 
their research elsewhere.
    The question we are then faced with is, will we also ban 
the potential lifesaving product as the result of this off-
shore--off-shore therapeutic cloning? Will we deny our 
constituents access to these phenomenal products?
    If we deem therapeutic cloning to be unethical, how can we 
possibly reverse course and reap the benefits of off-shore 
research? This is a question for another time, but it is one 
that I think members should be aware of as they contemplate the 
effects of our actions on future discoveries.
    In closing, I would like to again caution members against 
making a quick decision on this issue. There are obviously many 
points of view to be considered, and our witnesses today will 
add significant substance to this debate.
    However, we are essentially debating a single tradeoff: it 
is more important to enact a broad ban----
    Mr. Bilirakis. Please finish up.
    Mr. Deutsch. [continuing] that would prohibit research, or 
should we spend a little extra enforcement to narrow a ban on 
reproductive cloning while allowing lifesaving research to 
continue? I ask the members to keep that in mind as we proceed. 
Thank you, Mr. Chairman.
    Mr. Bilirakis. Dr. Ganske for an opening statement.
    Mr. Ganske. Thanks, Mr. Chairman. I will be brief. Cloning 
a human being is immoral, period. I believe there is wide-
spread, bipartisan agreement on that. Some people sort of shrug 
their shoulders and say, ``Well, somebody is going to clone a 
human being. What can you do about it?''
    I say we rise up in moral outrage and that we pass laws, 
both in this country and internationally, to prevent the 
cloning of a human being.
    We need to look carefully at the total issue. There are 
some who would say we should not allow stem-cell research. 
There are some that would say we shouldn't allow any 
``cloning'' at all.
    And Mr. Chairman, I remember years ago, when I was taking 
care of a little boy who had a 95 percent burn over his entire 
body, and it was one of the first uses of cell lines that were 
grown from that little boy.
    Now, under some definitions, that could be termed a 
cloning, a product to create those sheet of epithelium that 
were used.
    As we look at this issue, let us agree, no cloning of human 
beings, and let us also look very closely at the language of 
any legislation so that we do not prevent the ability to 
effectively treat certain disease conditions. And with that, I 
yield back.
    Mr. Bilirakis. Thank you, gentleman. Mr. Stupak?
    Mr. Stupak. Thank you, Mr. Chairman, and thank you for 
holding this very important and timely hearing. I think it is 
obvious which bill I support, H.R. 1644, the Weldon-Stupak 
Human Cloning Prohibition Act of 2001.
    H.R. 1644 amends the U.S. Criminal Code to ban the creation 
of cloned human embryos for research or reproductive purposes. 
What our bill would do is to prohibit performing, or attempting 
to perform, human cloning; participating in an attempt to 
perform human cloning; shipping or receiving the product of 
human cloning for any purpose; and importing the product of 
human cloning for any purpose.
    It draws a very bright line as to what activities are 
specifically prohibited. Many people have attempted to paint 
this bill as hand-cuffing the bio-technology and bio-research 
efforts currently underway.
    The truth is, there is no cloned human embryo testing going 
on. And so, the arguments we will hear against this bill today 
will be conjecture at best; as in, we think this may happen, 
but we are not sure. Well, Mr. Chairman, I would like the 
researchers to be a bit more sure before they begin creating 
human clones.
    The Weldon-Stupak bill intentionally steers clear of issues 
such as animal cloning, in vitro fertilization or IVF, and 
allows cloning techniques to produce DNA, cells other than 
human embryos, tissues, and plants.
    It also stays clear from stem cell research because, and I 
want to make this point very clear, stem cell research is being 
done on existing embryos at IVF clinics. The Weldon-Stupak bill 
does not prohibit this type of research on existing human 
embryos that are already slated for destruction. Therefore, 
stem cell research can and will go on.
    This is not a Republic versus Democrat issue. H.R. 1644 
reflects that. Currently, we have 105 co-sponsors, 19 of which 
are Democrats, much more bipartisan than any other cloning 
bill.
    Some people have painted this bill as a pro-life vehicle. 
This is not true. I would like to point out the United 
Methodist Church has endorsed the Weldon-Stupak bill, as well 
as our witness today, pro-choice advocate, Judy Norsigian.
    H.R. 1644 is an ethical bill about an ethical, moral, and 
legal problem. And I am proud that is able to reach across the 
divisive pro-life/pro-choice lines.
    Another point that will be brought up in today's hearings 
by pro-cloning advocates will be what is called therapeutic 
research. Briefly, these advocates say that cloning of human 
embryos is essential for organ transplant.
    To explain, let us say I have a faulty heart. Pro-cloning 
researchers will say, ``Let me clone myself, using an embryo, 
exact my own stem cells within to grow new heart cells to 
replace the damaged. Then, implant these cells.''
    This will, so the theory goes, cut down on transplant 
rejection and cut down on the brutal immuno-suppressive drugs. 
My question is, why not clone my heart cells and cut out on the 
uncertain step of directing embryonic stem cells to become 
heart cells?
    Finally, some have mentioned their concern with the lack of 
a sunset date, thus forever ruling out human embryo cloning. 
This is not true.
    The Weldon-Stupak bill has a provision that directs 
scientists to come back to us when they feel that can make an--
when they feel they can make a strong case for human embryo 
cloning. This puts the burden of proof on the researchers, 
which is where it should be.
    One last distinction between our bill and the other human 
cloning bills: our bill bans a specific act. The Greenwood-
Deutsch bill, for example, bans intent, a much more blurred 
standard.
    Thank you, Mr. Chairman. I look forward to the testimony of 
our witnesses, and I welcome Mr. Allen, the Deputy Secretary of 
HHS.
    Mr. Bilirakis. The Chair thanks the gentleman. Dr. Norwood 
for an opening statement?
    Mr. Norwood. Thank you very much, Mr. Chairman, and I will 
try to get you back on schedule. I will be brief. Let me say to 
Mr. Allen, we are delighted you are here. And I thank you very 
much, Mr. Chairman, for holding this hearing.
    I am really here today to listen. What was once considered 
science fiction now has become a reality, human cloning. And 
with that reality comes the ability to discover new treatments 
and treatments for conditions and diseases, perhaps even ways 
of preventing them from occurring at all.
    I believe that we should move cautiously in considering any 
legislation that would arbitrarily close the door on important 
avenues of research.
    Now, we have two bills before us, and I am a co-sponsor of 
the Weldon-Stupak bill. But I admit, I am also very interested 
in the approach Mr. Greenwood has taken. I believe that we need 
to give these bills great scrutiny to make sure that we 
understand all the potential consequences of both bills.
    Again, Mr. Chairman, I thank you for holding this hearing. 
I commend you for your efforts to further examine this issue of 
cloning, and I look forward to hearing from our witnesses 
today, and would gladly yield back the balance of my time.
    Mr. Bilirakis. And I thank the gentleman for that. Mr. 
Strickland for an opening statement?
    Mr. Strickland. Thank you, Mr. Chairman. Mr. Chairman, I 
woke up this morning, thinking about a young man in my district 
who is in his late 20's who, in his early 20's, had a serious 
car accident, and is unable to even breathe on his own. He has 
24-hour care. He has back-up power in case the electricity 
would fail so that he could continue to breathe.
    That young man, I hope someday, will have hope that he, and 
others like him, will no longer be required to spend his entire 
life in bed, being cared for by others.
    I was thinking of him because I knew I was coming to this 
hearing, and I knew that what we were going to be talking about 
this morning was very important. I absolutely agree with what 
Dr. Norwood just said. We should be very careful that we not 
close the door, at least at this stage of our knowledge, on 
efforts to advance science and medicine.
    We are opposed to the cloning of human beings. But we need 
to be very careful; and I hope we, as a committee, will be 
very, very careful, that we not allow theology or philosophy or 
politics to interfere with the decisions that we make here, but 
that we make sure that the decisions we make are based upon 
sound science.
    I am a United Methodist. My friend, Mr. Stupak, is a Roman 
Catholic. But I think neither of us can allow our churches to 
tell us how to respond to this issue. I am not--I am not 
implying that that is true of either of us, but I do believe 
that there is a danger with this issue of allowing it to get 
caught up in matters which are apart from science and our 
responsibilities as Representatives to support sound science.
    I haven't made up my mind on which bill I am going to 
support, but I am convinced that what we are doing today is 
important and vital, and it will ultimately affect huge numbers 
of the American people. And for that reason, we ought to 
approach it with the utmost seriousness of purpose.
    Thank you, and I yield back my time.
    Mr. Bilirakis. And I thank the gentleman. Mr. Bryant for an 
opening statement?
    Mr. Bryant. Thank you, Mr. Chairman. I have been sitting 
over here, making notes and deciding whether I want to give an 
opening statement or not, and trying to move things along. And 
I thought I could echo and join in my--my good colleague from 
Michigan's statement, Mr. Stupak.
    And I certainly agree with him 100 percent, and I thought I 
could end it right there. But as I continue to hear some of the 
statements about--being made about this research and the need 
for it, which I don't quarrel with that, and I don't quarrel 
with these many, many difficult circumstances, these terrible 
cases where people have been hurt or--or have diseases; and 
certainly somewhere down the road, perhaps research can 
discover a cure or something to help them.
    And we all support that. Those are terrible cases. But we 
do look at things like theology, and philosophy, and even 
politics, up here on everything we do. We operate in a world 
not purely humanistic, not just on science. We draw lines all 
the time out there.
    We don't let prisoners sell their organs, or anybody, for 
that matter, sell their organs. We don't require prisoners to 
give up organs because they are in prison. We don't grow 
people. We don't create people for organ harvesting and things 
like that, and other body parts. We don't kill seniors, at 
least yet, for lack of a quality of life and things like that.
    So, I think we operate in a bigger world than simply sound 
science. There is no question sound science plays a role in so 
many things. But yet, when you are dealing with such deep, 
moral issues, for many of us who do have a clear definition of 
where we think life begins, I think you could find people that 
could say anything about that.
    Some say at the beginning, when the sperm meets the egg, 
perhaps now survivability and with the technology that we have 
got to keep these little premature babies alive, you know, when 
is that? The law in my State, in Tennessee, in civil cases is 
viability. And some might even say, you can argue through 
partial-birth abortion, is it doesn't begin until the baby is 
actually born.
    You have got people that will say all kinds of definitions 
there. And if I am going to make a mistake on when that life 
begins, I am going to try and err on the side of life, and give 
the benefit, the most generous benefit.
    Even in our criminal courts today and our law system, 
people who are sentenced to death have layers of appeal because 
we give them the benefit of the doubt. And yet, in situations 
like this where perhaps we are creating lives there and then 
destroying those lives, there is no--no one advocating for 
them.
    So, I think there are difficult issues here. 
Unquestionably, there are terrible cases that we have to deal 
with. We have to have this research. And I am just optimistic, 
and hopeful, and encouraged that there are other ways we can 
get to this research through the tissue replication, as I 
understand it--I am not a doctor--something short of having to 
create, in my--in my belief, a life, and then destroy that life 
to help these very difficult circumstances.
    And again, I just--I hope there is another way to do this. 
And I am encouraged, and I am glad to have all of the different 
opinions here today. I want to listen as much as I can. We have 
got schedules for--we are in and out a lot.
    But I do--I did feel it necessary to at least respond in 
part to some of the statements that are being made in--in this 
regard. And for that, Mr. Chairman, I thank you again for 
holding this very important hearing, and I would yield back my 
time.
    Mr. Bilirakis. The Chair certainly thanks him. Mr. Green 
for an opening statement?
    Mr. Green. Thank you, Mr. Chairman, and thank you for 
holding the hearing on these two bills which address the 
controversial issue of human cloning. Cloning was once the 
subject of science fiction novels. Many of us associate cloning 
with the disturbing notion of designer babies or a human race 
that is void of individuality or spirit.
    And we remember Huxley's ``Brave New World'' and the 
frightful images it conjured up of genetically manipulated and 
cloned individuals. What was once science fiction could become 
a reality.
    In 1997, the cloning of Dolly the sheep opened up all our 
eyes to the possibility of human cloning. Human cloning either 
for therapeutic or reproductive purposes raises a number of 
ethical concerns that this committee and our Nation must 
consider.
    If animal cloning has taught us anything, it is that 
cloning has significant risk. Miscarriages, birth defects, and 
genetic problems are the norm when it comes to cloning. Less 
than 3 to 5 percent of cloned animal embryos survive. In fact, 
it took more than 270 tries before scientists were able to 
clone Dolly.
    Despite these risks, a March 28 Oversight and 
Investigations Subcommittee hearing demonstrated that there are 
fringe groups who intend to clone human beings without regard 
to the consequence of such activities.
    I think that most people on this panel would agree that the 
risk associated with human reproductive cloning far outweigh 
any potential benefits, and that this kind of activity should 
be banned. That much is evident as both of the bills we're 
considering ban human cloning for reproductive purposes.
    However, there is another side to cloning, therapeutic 
cloning, which holds great promise for the treatment of a range 
of diseases such as diabetes, heart disease, organ failure, 
spinal cord injury, and Parkinson's disease.
    Many members of the scientific community believe that in 
order to unlock these mysteries, we must perform research on 
cloned human embryos. That is where these two bills depart.
    Mr. Chairman, no one in this room knows any degree of 
certainty whether cloning research will achieve the goals it 
has promised, but we will never know the full potential of this 
technology if we stop it in its tracks.
    Rather than throwing up an arbitrary roadblock on these 
scientific avenues, as one of these bills does, we should 
proceed with caution. And I hope the committee will consider 
all of the elements before we pass legislation which could have 
a chilling effect on research for treatments of some of our 
most dreaded diseases. Thank you, and I yield back my time.
    Mr. Bilirakis. The Chair thanks the gentleman and will ask 
for the statement of Mr. Pitts.
    Mr. Pitts. Thank you, Mr. Chairman, and thank you for 
convening this important hearing today on the issue of human 
cloning. As science rapidly advances in our Nation and our 
world, we, as legislators, are faced with ethical dilemmas as 
we attempt to make sure that our world doesn't begin to 
resemble Huxley's ``Brave New World.''
    While we want to encourage lifesaving, scientific advances, 
we must not let science advance in a moral vacuum. Americans 
agree. In fact, in a poll by Time/CNN in March of this year, 90 
percent of those polled opposed human cloning.
    While there is agreement that we must ban cloning, there is 
disagreement on the best way to do this. And today, we will 
hear testimony on two, radically different approaches to 
banning cloning.
    The Greenwood bill would place a 10-year moratorium on 
implanting a cloned embryo in a woman's uterus. The Weldon bill 
would ban both the creation of a cloned embryo and the 
implantation of a cloned embryo.
    Regardless of whether members are pro-choice or pro-life, 
it can be argued that the only effective way to ban cloning is 
the way it is done in the Weldon bill.
    For example, if there were only a ban on implanting a 
cloned embryo, what happens when one of the cloned embryos is 
implanted in a woman's uterus, which we know could occur at 
some point? Would the woman be taken into custody and forced to 
have an abortion?
    Regardless of the moral issues that some of us have with 
the Greenwood approach of creating life for the explicit 
purpose of research and then destroying it, I simply believe 
that this approach of only banning implantation is completely 
unenforceable.
    Roe v. Wade, the Supreme Court decision, guarantees women 
the right to choose. I can't imagine that supporters of Roe, or 
anyone else for that matter, would force a woman who has had a 
cloned embryo implanted in her uterus to have an abortion. This 
is not China.
    Another determination that needs to be made when we 
consider these young, living, human embryos is do they have the 
quality of people or property? If they are property, then we 
can do with them what we wish, including research, 
experimentation, destruction.
    If they have the quality of people, although very tiny, 
very young, live human beings, they should not be created for 
experimentation and destruction and harvesting, no matter how 
sophisticated or therapeutic or regenerative.
    As someone has said previously, human cloning is immoral. 
Are we going to permit the creation of a whole new class of 
human beings just for research, experimentation, harvesting, 
and destruction?
    So, I fear the outcome of anything less than a complete ban 
on cloning, both embryonic and reproductive, would result in 
cloned human beings in America actually being implanted and 
being born.
    I look forward to hearing the testimony from our 
distinguished panel of witnesses today.
    Mr. Bilirakis. The Chair thanks the gentleman. Mr. Barrett 
for an opening statement?
    Mr. Barrett. Thank you very much, Mr Chairman. I will be 
brief. I want to thank you for convening this hearing. I think 
that previous members from both sides of the aisle and both 
sides of this issue have pointed to the thorny nature of the 
debate that we face today.
    And I--rather than expounding on what may or may not 
happen, I am frankly looking forward to hearing from the--from 
the different witnesses to see what the administration's 
viewpoint is, and what the various other members of the panel 
have to offer. So, I would yield back the balance of my time.
    Mr. Bilirakis. I thank the gentleman. Let the record show 
that Ms. Wilson and Mr. Buyer are present, and have waived an 
opening statement. And even though she is not a member of this 
subcommittee, Ms. DeGette has requested the opportunity to make 
a brief opening statement, and the Chair now recognizes her.
    Ms. DeGette. Thank you, Mr. Chairman. And it is really good 
to be back with my colleagues, even just for a brief moment. At 
the Oversight and Investigations hearing we held in March, all 
of us were horrified, collectively, at the testimony of experts 
in animal cloning who talked about the results that we don't 
hear about in the media with Dolly and so on, but the failed 
results and the grotesque results that came from animal 
cloning.
    And we agreed, collectively, that cloning--human cloning 
was immoral, and that human cloning was impractical and should 
not occur. What is--we were also equally horrified at the 
cavalier attitude of some of the proponents of human cloning 
who testified at that hearing.
    And we were all shocked about their complete lack of 
understanding about the moral, ethical, and physical 
implications of attempting human cloning.
    And so, I welcome legislation to ban cloning. But at the 
same time, we need to understand what so many of my colleagues 
have talked about today here.
    Increased understanding about the human genome, as well as 
the rapid advancement of technology, have prompted significant 
controversy about the possible application of cloning 
techniques of humans and whether there are appropriate 
applications.
    The Greenwood-Deutsch bill prevents the abuses of human 
cloning while, at the same time, allowing for appropriate 
continued research in an area of science that holds answers, 
answers which could affect the lives of millions of Americans 
who are affected by so many diseases, as we have heard, from 
diabetes to Alzheimers to Parkinson's to different kinds of 
paralysis, and on, and on.
    Therapeutic cloning, if appropriately done and if it is 
matched with appropriate safeguards, can hold so many of the 
keys that it would be irresponsible for Congress to pass 
legislation which would not allow this very targeted type of 
research to continue.
    And so, Mr. Chairman, I thank you for having this hearing, 
and I also would caution my colleagues; we must be very 
careful. We cannot pass a bill simply because it seems 
politically expedient.
    Too many lives of Americans are at risk. And we need to be 
very careful that while we are banning human cloning, we also 
don't stop research that will benefit so many millions of 
Americans. With that, I yield back the balance of my time.
    Mr. Bilirakis. I think the gentlelady. That completes 
opening statements. As I had said earlier, the opening 
statements of all members of the subcommittee are made a part 
of the record.
    [Additional statements submitted for the record follow:]
 Prepared Statement of Hon. Ed Whitfield, a Representative in Congress 
                       from the State of kentucky
    Thank you Mr. Chairman. The debate on human cloning represents one 
of the most controversial and important issues facing our nation and 
society today. Rapid advances in biotechnology have transformed what 
was only recently an abstract hypothetical question into a very 
tangible and pressing legislative problem.
    The American people look to their representatives in Washington for 
leadership and careful deliberation on the subject of human cloning. As 
a Committee, we are charged to reach a conclusion that will preserve 
the sanctity and uniqueness of human life without impeding important 
biomedical research that promises to improve the health of millions of 
Americans.
    While both the Weldon-Stupak and Greenwood-Deutsch bills explicitly 
ban the cloning of human beings, their differing approaches attempt to 
resolve the predicament using varying degrees of restriction. H.R. 1644 
enjoins all research utilizing somatic cell nuclear transfer, 
prohibiting both reproductive and therapeutic cloning procedures. In 
H.R. 2172, however, Reps. Greenwood and Deutsch limit the ban to 
include only human embryonic cells intended for developing human 
clones. Any use of the nuclear transfer technology for purposes other 
than developing a human clone would remain lawful.
    Our challenge is to carefully consider the potential benefits and 
dangers of human cloning technologies, avoiding any unintended 
consequences of permitting or banning cloning research. I look forward 
to listening to the testimonies of our panel of witnesses and the 
opinions of my colleagues in order to reach a satisfactory answer to 
this most difficult question.
                                 ______
                                 
Prepared Statement of Hon. Barbara Cubin, a Representative in Congress 
                       from the State of Wyoming

    We are fortunate today in that we have many powerful incentives to 
drive innovation; incentives that on the surface seem less than 
admirable: money, power, glory, prestige.
    I say fortunate however because without the many innovations we 
have seen over the past decade--in medicine, technology, energy, 
aerospace and so on, we would not be living as comfortably as we are 
today.
    In fact, some of us might not even be here without the many 
breakthroughs in medical science. For that, we should be very grateful.
    There is however another aspect to innovative research, one of 
which we should be particularly mindful.
    At what point does research go too far? At what point does research 
lead us to a place where maybe we shouldn't be? It is herein that lies 
the controversy.
    It seems like we are in a race to understand the great mysteries of 
life, death, birth, disease, race, time--and the many other unknowns 
that we face.
    In so many ways, discovery has been a blessing to us, especially 
when it comes to medical science, but sometimes we are in such a hurry 
to see what we can do that we don't stop long enough to decide whether 
we should.
    One prime example of that is the cloning of human beings. This 
process comes dangerously close to wielding one of the most awesome 
forces in nature.
    We haven't the slightest idea what to expect in the aftermath of 
cloning humans and, quite frankly, I think it is a dangerous 
proposition with which to play.
    I want us to stop and think carefully about what we do in the name 
of research. It can be a wonderful thing, but it also demands great 
responsibility and humility.
    As I consider this issue in the grand scheme of things, I cannot 
support cloning human embryos, and am very concerned about the 
possibility of cloning these embryos solely for research purposes, only 
to destroy them later. That just doesn't hold true to my idea of the 
spirit and intent of medical research.
    I look forward to hearing from our witnesses today, and appreciate 
the chairman indulging me on this issue.

    Mr. Bilirakis. And the Chair now welcomes Mr. Allen, with 
apologies for your sitting there all of this time listening to 
us talk. But you are probably relatively accustomed to that.
    Mr. Allen is the Deputy Secretary of the Department of 
Health and Human Services. Sir, your written statement, of 
course, is already a part of the record. We will set the clock 
at 10 minutes. And I would hope that you would supplement and 
compliment that written statement. Please proceed.

STATEMENT OF HON. CLAUDE A. ALLEN, DEPUTY SECRETARY, DEPARTMENT 
                  OF HEALTH AND HUMAN SERVICES

    Mr. Allen. Thank you, Mr. Chairman and members of the 
committee I am Claude Allen, Deputy Secretary of the Department 
of Health and Human Services. And while it is true that having 
sat through all of the opening statements, it has been very 
enlightening.
    This is, indeed, my first appearance before this committee 
in this capacity, as I have been on the job all of 2 weeks now.
    I do want to say that I appreciate this opportunity to 
discuss the position of the administration regarding the 
cloning of human beings. Secretary Thompson is working this 
week at the Health Resources and Services Administration, and 
regrets that he could not personally be here to give this 
testimony.
    The moral and ethical issues posed by the prospect of 
cloning human beings are profound and demand our unflagging 
attention. And I know the members have given much of your 
attention in that very way.
    Secretary Thompson and President Bush make it very clear 
that they oppose any and all attempts to clone a human being. 
We oppose the use of human somatic cell nuclear transfer 
cloning techniques either to assist human reproduction or to 
develop cell or tissue-based therapies.
    At the same time, the Secretary and the President strongly 
support other approaches to development of these therapies, 
such as research with genes, cells, or tissues from humans or 
animals consistent with current law.
    Current biomedical science is riddled with vast areas of 
uncertainty about somatic cell nuclear transfer techniques and 
the consequences of their use. We, therefore, believe that any 
attempt to clone a human being, not only would present a grave 
risk to the mother and the child, but also would pose deeply 
troubling moral and ethical issues for humankind.
    Further, we support both the Presidential directive already 
in place that prohibits the use of Federal--of government funds 
for cloning human beings and the current restrictions on HHS 
appropriations that bar the use of Federal Government funds to 
create human embryos for research purposes.
    The American Medical Association Policy Statement E2.147 
issued in 1999 stated further--that further investigation and 
discussion of the harms and benefits of human cloning is 
needed, and the potential for unknown physical and 
psychological harm, including violations of privacy and 
autonomy, are significant.
    Ian Wilmont, as many have already noted, the scientist who 
cloned Dolly the sheep, has come out publicly against human 
cloning, stating that the risks inherent in cloning mammals are 
so great that it is ``criminally irresponsible'' to experiment 
with humans.
    After 4 years of experience in animal cloning techniques, 
the failure rate is 98 percent. Animals that survive have 
problems with abnormal--abnormally high birth weight, extra 
large organs, heart troubles, even poor immune systems. These 
animals are often euthanized to end their suffering.
    It is clear that this administration has a moral imperative 
to prohibit the use of cloning technology for the purposes of 
creating a human being for reproduction or for research.
    At the same time, we look forward to working with the 
committee and the members on your--and the colleagues in 
Congress in sustaining life-giving research into cell and 
tissue-based therapy to combat disease.
    On behalf of Secretary Thompson and the President, let me 
thank you all for holding this hearing. It does address very 
critical issues that we must confront.
    I will end by saying that I think Mr. Pitts, Congressman 
Pitts, really stated it the best when he said that we must not 
let science advance in a moral vacuum. The times in society 
when we have done that have resulted in great disasters, times 
when we have turned our back on our fellow men and women in 
this country and around the world.
    We believe, at the Department of Health and Human Services, 
that the committee's work should be applauded in carefully 
considering and carefully reviewing these matters that have 
such critical importance to the future of not only those who 
may benefit from therapy, but also for society itself.
    With that, I will stop and entertain any questions. There 
are many other issues that I think have been addressed in my 
written statement. Mr. Chairman, if I may also, at the very 
beginning, I meant to apologize for the committee receiving my 
testimony late last evening.
    It is not designed to prevent you from having an 
opportunity to review it. It was simply late in the night that 
we were able to get it finally worked out and get it up here to 
you. So, please accept my apologies for that, as well as the 
Department's.
    [The prepared statement of Claude A. Allen follows:]

Prepared Statement of Claude A. Allen, Deputy Secretary, Department of 
                       Health and Human Services

    Mr. Chairman and Members of the Committee, I am Claude Allen, 
Deputy Secretary of the Department of Health and Human Services. I 
appreciate this opportunity to discuss the position of the 
Administration regarding the cloning of human beings.

                               BACKGROUND

    The moral and ethical issues posed by the prospect of cloning human 
beings are profound and demand our unflagging attention. Secretary 
Thompson and President Bush oppose any and all attempts to clone a 
human being. We oppose the use of human somatic cell nuclear transfer 
cloning techniques either to assist human reproduction or to develop 
cell- or tissue-based therapies. At the same time, we strongly support 
other approaches to development of these therapies, such as research 
with genes, cells, or tissues from humans or animals, consistent with 
current law.
    Any attempt to clone a human being not only would present a grave 
risk to the mother and the child but also would pose deeply troubling 
moral and ethical issues for humankind. Further, we support both the 
Presidential directive already in place that prohibits the use of 
federal funds for cloning human beings and the current restrictions on 
HHS appropriations that bar the use of federal funds to create human 
embryos for research.
    These matters are of special interest to the Department of Health 
and Human Services because attempts to use cloning technology to clone 
a human being are subject to both the biologics provisions of the 
Public Health Service Act and the drug and device provisions of the 
Federal Food, Drug, and Cosmetic Act. On March 28, an FDA 
representative testified on this subject before the House Energy and 
Commerce, Subcommittee on Oversight and Investigations. As indicated 
then, because of unresolved safety questions on the use of cloning 
technology to clone a human being, FDA will not permit such attempts. 
In 1998, FDA described its position in a widely circulated ``Dear 
Colleague'' letter.
    In keeping with the provisions of its statutory responsibilities, 
FDA's role in these matters is limited to scientific, technical and 
regulatory considerations. However, as noted by the President as well 
as by the National Bioethics Advisory Commission, additional concerns 
beyond the scope of FDA's role remain to be resolved ( especially the 
broad social and ethical implications of cloning human beings, such as 
whether the use of human somatic cell nuclear transfer is morally 
acceptable under any circumstance.

               COMMENTS ON PENDING LEGISLATIVE PROPOSALS

    The Administration favors the passage of specific legislation to 
prohibit the cloning of a human being, including cloning techniques 
either to assist human reproduction or to develop cell- or tissue-based 
therapies. We look forward to working with the Congress to achieve this 
goal. For today, I present our comments on the Cloning Prohibition Act 
of 2001 (H.R. 2172, introduced by Mr. Greenwood) and the Human Cloning 
Prohibition Act of 2001 (H.R. 1644, introduced by Mr. Weldon), 
respectively.
H.R. 2172
    H.R. 2172 focuses on preventing (a) the use of human somatic cell 
nuclear transfer (SCNT) technology to initiate a pregnancy or (b) the 
shipment or transportation of the product resulting from such 
technology if the product is intended to initiate a pregnancy. The bill 
does not restrict any other uses of human SCNT, such as creating human 
embryos for research purposes. This is a major concern to the 
Administration.
    To foster enforcement of its provisions, the bill requires that an 
individual who intends to perform human SCNT register his/her name and 
place of business. This registration must include a statement or 
attestation, signed by the individual, declaring that he/she is aware 
of the prohibitions specified in the bill and will not engage in any 
activity that violates them. The registration requirement could cover a 
substantial number of academic and industrial laboratories.
    The bill amends the Federal Food, Drug and Cosmetic Act to provide 
for criminal and civil penalties for any of the bill's prohibited 
activities. Moreover, to protect the confidentiality of the information 
that will be collected as a result of the registration process, the 
bill requires that the Secretary not disclose any of this information 
unless the registrant has provided authorization in writing or the 
disclosure does not identify either the individual or his/her place of 
business.

H.R. 1644
    H.R 1644 amends Title 18 of the U.S. Code to prohibit (a) 
performing or attempting to perform human cloning, (b) participating in 
an attempt to perform such activity, or (c) shipping, receiving, or 
importing the product of human cloning. To achieve these ends, the bill 
defines ``human cloning'' as follows:
        ``The term `human cloning' means human asexual reproduction, 
        accomplished by introducing the nuclear material of a human 
        somatic cell into a fertilized or unfertilized oocyte whose 
        nucleus has been removed or inactivated to produce a living 
        organism (at any stage of development) with a human or 
        predominantly human genetic constitution.''
    As we interpret the bill, it prohibits not only the use of human 
somatic cell nuclear transfer to initiate a pregnancy but also all 
other applications of somatic cell nuclear transfer with human somatic 
cells, such as cloning to produce cell- and tissue-based therapies. 
This is consistent with Secretary Thompson's and the President's views.
    Scientific research that is not specifically prohibited in the bill 
is unrestricted by it. Examples of research that are not prohibited are 
the use of nuclear transfer or other cloning techniques to produce 
molecules, DNA, cells other than human embryos, tissues, organs, 
plants, or animals other than humans. Penalties for violation of the 
bill's prohibitions include at least $1 million in civil penalties and/
or up to 10 years in prison.
    We support this bill's intent of banning human cloning, but believe 
that it warrants further review to resolve some technical issues.

                               CONCLUSION

    HHS applauds the Committee for addressing the issues associated 
with cloning human beings and welcomes the initiative of 
Representatives Greenwood and Weldon in offering specific legislative 
proposals. We look forward to working with the Congress to prohibit 
morally offensive uses of cloning technology without stifling the 
development of important cell- and tissue-based therapies to combat 
human diseases.

    Mr. Bilirakis. The Chair, on behalf of the committee, 
accepts your apology. Obviously, it is certainly helpful if we 
can get it on time.
    Mr. Allen. Certainly.
    Mr. Bilirakis. The staff--I know the staff was here until, 
what, 11:30 last night waiting for the testimony. They didn't 
have anything else to do, just sat waiting.
    Mr. Allen. Indeed, thank you.
    Mr. Bilirakis. The Chair recognizes himself for questions. 
Mr. Allen, given the administration's opposition to the 
creation of cloned human embryos, what uses of cloning 
technology does the administration support? Would it be 
anything that doesn't give rise to a human embryo?
    Mr. Allen. Mr. Chairman, I believe in my written statement, 
on page 6--and I will highlight that for you--we believe that 
there is already areas that can and should continue to see the 
research advance that are not prohibited by the use of somatic 
cell nuclear transfer, techniques such as using--that produce 
molecules, DNA, cells other than human embryos, tissues, 
organs, plants, and animals.
    And we believe that both of those areas are wide open. What 
we are focusing on is a very narrow area, and that is the use 
of the human cell, the somatic cell, for the purpose of 
cloning, whether that be for reproductive purposes or whether 
that be for what we have heard earlier described as therapeutic 
or research-based work.
    Mr. Bilirakis. You and I both have just used the word 
``human'' a couple of times. Let me ask you the question; what 
is human? If legislation were passed banning the creation of 
cloned human embryos, how would the administration interpret 
the word ``human''?
    Before you go into that, I sould share with you that there 
was a news story a while back that scientists created a monkey 
that contained a strand of DNA from a jellyfish, which served 
as a fluorescent marker for the embryonic-embryonic monkey.
    If this were done to a cloned human embryo, would this act 
render a human embryo into a chimera and therefore, not 
protected under the act? Would it be a loophole? Would the 
administration interpret anything that is predominantly human 
in origin in its genetic make-up to be considered human for 
enforcement purposes?
    Mr. Allen. Mr. Chairman, let me first say the 
administration has not taken a position on the findings that 
you----
    Mr. Bilirakis. Yes, that was going to be the next question.
    Mr. Allen. [continuing] and I just want to make that very 
clear. I think the fact that we would have to even go down that 
track to try to guess or define what ``human'' is raises some 
serious implications that go back to question both of the 
moral, legal, and ethical implications.
    However, I think your point of addressing the question, the 
word ``in origin'' certainly gives us some parameters to begin 
to look at, as we look to try to define that.
    We are human because--not simply because of our genetic 
make-up because, indeed, we do share 98 percent of our make-up 
with, for example, monkeys. But it is those characteristics 
that make us distinct from other mammals, even primates that 
make us distinct, such as our ability to reason, our moral 
conscience. These are things that make us human.
    So, I think to try to simply isolate it to a scientific 
definition, I think we are defeating the purpose of who we are 
as people, as individuals, as a species, that is distinct from 
all others. And that is not simply limited to our genetic make-
up.
    Mr. Bilirakis. Well, even though the administration has not 
taken a position on the Weldon bill--and I think we are all 
sort of curious about that--would you feel that maybe there 
should be a more succinct definition of the word ``human'' in 
any legislation that might progress through the committee?
    Mr. Allen. We certainly think that the reason we have 
withheld from endorsing either bill in this circumstance is 
because we believe there is room for a lot of technical 
improvement. And that certainly could serve as one of those 
areas that probably would need to be spelled out.
    Again, we know that, as a lawyer, that lawyers can 
certainly slice and dice words if you are not very careful 
about how you define. We would hope that that would not be the 
case.
    But certainly, that is an area that, should the committee--
and we will go back and look at that. We believe that we have 
opportunities to offer some technical advice in that area to 
clarify.
    Mr. Bilirakis. All right. I do believe that others will 
probably raise the question of why you have not chosen to 
endorse the bills. So, I will just go ahead and yield. Mr. 
Waxman to inquire?
    Mr. Waxman. Thank you very much, Mr. Chairman. Now, Mr. 
Allen, you say the administration opposes genetic cell 
replication and research, cloning that uses human egg cells to 
create genetically identical cells, but is not intended to lead 
to reproductive cloning to create a human being.
    In your statement, you explain why the administration 
opposes creation of a human being, but you don't explain why 
you oppose research that is not intended to create a human 
being. Why?
    Mr. Allen. Mr. Waxman, thank you for the question, and I do 
want to clarify it and make that very clear why we believe 
that. I think that the comments that have been made by the 
committee thus far really encapsulate much of that; and that 
is, that these are areas that go far beyond just simply 
science.
    They go to the heart of the moral, legal, and ethical 
questions that need to be raised about this area of research 
that we are going into.
    With regards to why we have not endorsed one of the bills 
versus the other, but we strongly believe that we need to ban 
both research and reproductive cloning is because leading down 
the track of research cloning, it is a very small step to have 
an embryo that was created for a clone for research purposes to 
be simply implanted into a woman that ultimately leads to----
    Mr. Waxman. But don't you draw any distinction between 
research that leads toward a human version of Dolly, the sheep, 
and research that uses egg cells to develop tissues for organ 
repair?
    Mr. Allen. Sir, I think you----
    Mr. Waxman. Don't you draw those distinctions in your mind?
    Mr. Allen. I think you can draw a distinction, but I think 
the question, once again, comes back to intent. It gets us to a 
place where we would have to interpret the intent of the 
individual or company or individuals who are creating for the 
purposes of research.
    A very simple example: a kid in a candy store. I own a 
candy store. My son works in that candy store, has access to 
everything; he is passionate about candy. It is a very small 
step for him to go from me telling him what is prohibited, 
``You may not have that,'' to simply taking one off the shelf 
and using it for that purpose.
    Mr. Waxman. Yes.
    Mr. Allen. I believe that, and the administration believes 
that, it is the best interest that, at this time, that we ban 
both research, as well as reproductive, cloning because of the 
easy step to take that moves us across that line that we all 
agree is reprehensible.
    Mr. Waxman. But can't you deal with intent? We deal with 
intent all the time in the criminal law.
    Mr. Allen. The issue of intent is--and the way that the 
language is written, and the bill focuses on the intent. But 
what we cannot deal with is we cannot stop once that process 
has taken place, once a human embryo that has been cloned has 
gone from the research laboratory, has been implanted into a 
woman, that area, then, we have gone down that path; we have 
made that step.
    And that is one that raises serious questions about what do 
you do at that point? I think there has been questions already 
raised about do you--you can punish the person for implanting 
it. Do you punish the researcher who did not know the intent of 
the person who would ultimately implant that in the----
    Mr. Waxman. Well, we are talking about, I gather, the 
intent of the researchers. But do you oppose this research 
because you think an egg cell with implanted core genetic 
material is the same as a human being?
    Mr. Allen. I am sorry; I missed----
    Mr. Waxman. Do you oppose this research because you think 
that an egg cell with implanted core genetic material is the 
same as a human being?
    Mr. Allen. That is not the basis upon which we are making 
this objection and opposition. We are basing it upon, again, 
the fear and the concern, the real fear and real concern----
    Mr. Waxman. That it will be misused?
    Mr. Allen. That is correct.
    Mr. Waxman. Okay. Does the administration oppose in vitro 
fertilization or research on in vitro fertilization?
    Mr. Allen. We do not oppose in vitro fertilization because 
there is a very significant distinction. In vitro fertilization 
involves the union of an egg cell, that is one set of 
chromosomes, with a sperm cell, a second set of chromosomes.
    And that is to produce a fertilized egg that has two sets 
of chromosomes. The distinction here when we are talking about 
the cloning is that the somatic cell nuclear transfer cloning 
involves the removal of the egg from a single cell, and the 
implantation, or the fusion, with a nuclear material to create 
one set that is identical to the source that it came from.
    So, there is a fundamental distinction between in vitro 
fertilization and what we are talking about here in banning, 
and that is to that cell nuclear transfer cloning.
    Mr. Waxman. Okay. Well, thank you. Your answers are very 
helpful, and we will think them through, and work with you on 
this. Thank you, Mr. Chair.
    Mr. Bilirakis. I thank the gentleman. Mr. Greenwood to 
inquire?
    Mr. Greenwood. Thank you, Mr. Chairman, and thank you for 
your testimony, sir. If I calculate right, this administration 
has been in office about 5 months?
    Mr. Allen. That is correct.
    Mr. Greenwood. That is right. This is a momentous--you 
would agree, I think, that this is a momentous issue for our 
future.
    Mr. Allen. Absolutely.
    Mr. Greenwood. Okay. Could you share with us, with this 
committee, with whom did this administration consult in order 
to arrive at its position which, as you stated, is that we 
oppose the use of human somatic cell nuclear transfer of 
cloning techniques either to assist human reproduction, which 
we all do, but--or to develop cell or tissue-based therapies.
    Now, with whom did you consult? With whom did this 
administration consult in order to arrive at that conclusion?
    Mr. Allen. Mr. Greenwood, the administration certainly has 
expertise within the Department itself, at HHS, whether it be 
NIH, the FDA, scientists within the administration. Outside, we 
also----
    Mr. Greenwood. Did this administration consult with the NIH 
and the FDA prior to coming to this conclusion?
    Mr. Allen. Certainly, we would have worked with them, and 
their input has gone into this decision. At a different level, 
however, I will say that it is very clear that, as has been 
indicated, that this involves significant policy issues that 
bear also on the views of the President and the Secretary as 
based upon the science that we have worked with, within the 
Department and outside of the Department as well.
    Mr. Greenwood. Very complex. For instance, did you bring 
BIO, the organization that represents the bio-technology 
group--did the administration bring BIO and the scientists who 
are involved in this kind of research to consult with them 
prior to formulating its views?
    Mr. Allen. Certainly throughout the time that this issue 
has been around, we have certainly consulted with and worked 
with representatives from all communities, the bio-tech 
community, the faith community, the legal community. We have 
worked with all because this issue does have implications for 
all.
    And for that reason--I cannot document for you at this 
point who everyone has met with within the administration. But 
certainly, there has been consultation and work with--as we 
have developed these positions.
    Mr. Greenwood. Now, Mr. Allen, when you--when you responded 
to Mr. Waxman's question on the--and you described the 
technical difference between a nuclear transferred embryo, if 
you will, and one that is produced by the union of the male and 
female reproductive cells--so, you correctly described why--the 
technical difference between in vitro fertilization and somatic 
and nuclear cell transfer.
    Now, what is the ethical distinction that you are making--
that this administration is making here?
    Mr. Allen. The administration has not made an ethical 
distinction between those two in this regard. What we are 
focusing on is--and I think the distinction, with all due 
respect, the Greenwood bill, is the distinction that is made 
there, that it is appropriate for banning it as far as 
reproductive purposes, but allow the research purposes to go 
forward.
    What we are concerned about, as I have stated earlier, is 
the fact that that is a very, very thin line to divide upon 
because it is too easy, too simple to cross that line.
    Mr. Greenwood. So, if I understand you, sir, what you are 
saying is that it is--that this administration's policy is 
based on not an ethical decision whether it is good for 
humanity to use this regenerative, therapeutic medicine to save 
the lives of potentially millions of people, but it is making a 
distinction on the basis--basis of that notion that the egg, 
that the cloned egg, once that process has occurred, could be 
diverted to break the law that I am trying to write, that it 
could be diverted for that purpose and go--become used as--for 
reproductive cloning.
    Is that the administration's position?
    Mr. Allen. If I understand your question, Mr. Greenwood, 
the administration's position would be that we believe that--
that both reproductive and research purposes of cloning, using 
somatic cell nuclear transfer cloning, would be what we support 
in prohibiting for the mere reason that it is a very easy leap 
from one to the other.
    Beyond that, I think it is important to recognize that is 
not simply based upon science. It is not simply based upon 
moral or ethical considerations. It is based upon the 
combination thereof.
    And as a policy decision, we believe that, at this time, 
that it is important that we send a very strong message that 
human--that the production or the creation of a human being by 
the means of cloning, whether accidental or intentional, should 
be banned.
    Mr. Greenwood. Well, we all agree on that. But what I am--
what I am trying to hone in on here is this administration is 
not taking the position that something unethical or immoral has 
happened at the moment of the somatic cell transfer, but rather 
it is the potentiality of that cell then being implanted in the 
uterus that is the danger?
    Even though we outlaw that in our bill, it is the 
potentiality that that could be transferred----
    Mr. Bilirakis. Very, very brief response to that.
    Mr. Allen. I think that is a fair----
    Mr. Bilirakis. The gentleman's time has expired.
    Mr. Allen. Yes, I think that is a fair summation of the 
position.
    Mr. Greenwood. Thank you.
    Mr. Bilirakis. Mr. Deutsch?
    Mr. Deutsch. Thank you, Mr. Chairman. You indicated that 
the administration supports legislation to ban therapeutic and 
reproductive cloning. Can you indicate how this ban that you 
endorse will be enforced?
    Mr. Allen. Well, I believe, at this point, what we are 
looking at is the enforcement mechanisms that are cited in the 
bills before us. Certainly, the FDA plays a role in that as it 
regulates both the biological and other aspects, both under the 
products bill as well as the FDA's other statutory authority to 
do so.
    It has enforcement mechanisms, and we currently do that in 
other areas. And we believe this would be similar to that as 
well.
    Mr. Deutsch. All right. Again, just from an enforcement 
standpoint, would you wait until you hear a tip or require some 
information indicating that someone wants to clone, or will you 
act perspectively by doing random site visits and interviews?
    Mr. Allen. I believe the FDA does both at this time. We 
receive tips, and we do act upon random site visits consistent 
with the authority that the FDA already has in both of these 
areas.
    Mr. Deutsch. All right. The administration budget recites 
the grim statistics on the lower number of site inspections on 
foreign and domestic facilities under FDA jurisdiction. The FDA 
cannot even identify all the facilities that make prescription 
drug ingredients that are introduced into commerce in this 
country.
    FDA and Customs inspect less than 1 percent of imports of 
food, drugs, and other items under FDA jurisdiction. NIH says 
that it lacks expertise on the subject of cloning. What 
assurance can you give that the administration is serious about 
enforcing a ban on human cloning?
    Mr. Allen. We would work with--in this area, certainly 
there are a number of options available to the administration. 
Certainly, we can re-deploy existing resources within the 
Department to try to begin to address these issues, as well as 
seek additional appropriation should that be necessary to do 
so.
    But the FDA currently believes that it is able to enforce, 
and does enforce, the laws as they currently exist. And this 
would be simply a further area for----
    Mr. Deutsch. Is the deterrent effect of the Weldon bill 
sufficient prevention for the cloning of humans?
    Mr. Allen. Could you resay----
    Mr. Deutsch. The Weldon bill, the prohibitions that it has, 
do you believe that is a sufficient deterrent?
    Mr. Allen. We believe that the Weldon bill does suggest, 
and leads in the right direction, of what we believe is a 
policy statement that should be enforced. And that is a total 
ban on human cloning. We believe there are some technical 
adjustments to the bill that probably could improve upon, and 
that is what we are willing to work with the committee and the 
Congress on to try to accomplish.
    Mr. Deutsch. Earlier this year, the Oversight and 
Investigations Subcommittee held a hearing on the subject of 
human cloning. At that hearing, and the media events 
approximate to it, various individuals, some claiming to be 
aliens, made statements to the effect that they intended to 
clone a human being in the United States in the near future.
    The FDA testified that they were aware of these claims and 
were investigating the matter. Can you tell us, in detail, what 
steps the administration has taken since then to investigate 
these matters and, if necessary, to stop human cloning.
    Mr. Allen. I know that the administration--the FDA is 
currently looking into these assertions of the possible 
existence of a human cloning laboratory here in the United 
States. And it is FDA policy not to discuss publicly 
investigation techniques or strategy.
    However, Dr. Zahn is here from the FDA, has testified on 
these areas in the past, and I believe she would be prepared to 
give you some more detail on that at the appropriate time.
    Mr. Deutsch. So, it is fair to say that there is an ongoing 
investigation then?
    Mr. Allen. It is fair to say that we are aware of it and 
are investigating, yes.
    Mr. Deutsch. Okay, let me ask you a question regarding the 
administration's position. You know, obviously, there is this--
the issue that--in terms of what we call therapeutic cloning, 
that the research potential is incredibly dramatic. And the 
administration's proposal, as I understand it at this point, is 
to ban those.
    And I understand the policy reasons why you are suggesting 
to ban those. I think what is clear from my opening statement, 
I mentioned that it is clear that this research is going to go 
on whether or not the United States bans it.
    It is going to go on in other countries because other 
countries do not consider it the same as the administration's 
position. Would that then be the administration's position to 
ban the importation of drugs that were--that were basically 
researched or, in fact, substances that were the benefits of 
human--of stem cell research?
    What would the administration's position be in that area?
    Mr. Allen. The administration has not taken a position on 
that at this point. What we are focusing on are the two bills. 
Of course, the Weldon bill does--I am sorry, the Weldon-Stupak 
bill does focus on importation and banning that.
    And for that reason, we believe that that is an appropriate 
response under the legislation to do so. But the administration 
has not formulated a position as to----
    Mr. Deutsch. Again, I really--I am going to ask that 
question again and try to hear a clear answer because, to me, 
it is--it is, you know, really almost shocking what you have 
just said, that in a case of the research--because this is 
not--I mean, it is hypothetical at this point, but some of the 
potential seems incredible, as Mr. Strickland mentioned.
    And I think talking about the reality, talking to families, 
talking to real people who are suffering from incredibly 
debilitating illnesses where it is clear that the potential to 
make, you know, absolutely miraculous recoveries, that, in 
fact, your position would be that if those drugs existed to 
cure paralysis, to cure cancer, that your position would be 
that those drugs would not be able to be imported into the 
United States of America.
    Mr. Bilirakis. Let us finish up here.
    Mr. Allen. Certainly. Congressman Deutsch----
    Mr. Bilirakis. The time has expired.
    Mr. Allen. [continuing] it should not be remarkable that we 
are not outright saying that we would allow the importation of 
that. The FDA does that every day. There are many drug 
therapies and other techniques that may have been developed 
elsewhere, but we have a responsibility to protect the health 
and safety of Americans.
    And absent a review of that and consideration of the impact 
that that may have on human life, it would not be irresponsible 
to say we would ban it at this point. But we leave open the 
possibility and the prospect that should there be developed, 
and should there by, hypothetically, therapies that could 
benefit American people, it will go through the same process by 
which we would allow that to take place and to be imported into 
this country.
    Mr. Bilirakis. Dr. Ganske to inquire?
    Mr. Ganske. Thank you, Mr. Chairman, and thank you, Mr. 
Allen, for being with us today. Up until just a few days ago, 
Secretary of Health and Human Services, Tommy Thompson, was 
saying that he, ``wasn't sure what the President's position 
was.''
    Now, we have your statement today, and this is the 
President's position. Is that right?
    Mr. Allen. That is correct.
    Mr. Ganske. And this is the Secretary's position?
    Mr. Allen. That is correct also.
    Mr. Ganske. All right. Well, let us--I just want to be 
absolutely clear on this. On page 5, you say, ``As we interpret 
the bill, it prohibits not on the use of human somatic cell 
nuclear transfer to initiate a pregnancy, but also all,'' 
underline that, ``all other applications of somatic cell 
nuclear transfer with human somatic cells, such as cloning to 
produce cell or tissue-based therapies.''
    That is consistent with Secretary Thompson's and the 
President's views? Let us just be absolutely clear.
    Mr. Allen. That is correct.
    Mr. Ganske. Okay. So, now, are you saying that it is the 
administration's position that it should be illegal for anyone 
to do somatic cell nuclear transfer?
    Mr. Allen. Within the context of the jurisdiction of the 
United States, that is correct. That is what we have the 
authority to control.
    Mr. Ganske. So, the ongoing work in that area you would 
make illegal?
    Mr. Allen. At this point, what the administration's 
position is, as stated there, is indeed the use of somatic stem 
cell nuclear transfer cloning techniques are what we are 
focusing on here. And that is the administration's position.
    Mr. Ganske. How does the administration answer the groups 
like Juvenile Diabetes, and the groups that are concerned with 
spinal cord injury, the groups that are looking--that the--the 
kidney failure groups that are looking to potentially be--we 
have a tremendous shortage of kidneys. They are looking for an 
opportunity to be able to develop a kidney. I am kind of 
interested in an answer.
    Mr. Allen. The position. It is focusing solely on the use 
of a technique of somatic cell nuclear transfer for cloning 
purposes. We are not saying that other techniques that are 
currently proven to be efficacious for the very issues that you 
have raised could not be continued. That research is untouched.
    Mr. Ganske. Is the administration aware that there are a 
number of very pro-life United States Senators who have 
expressed an opinion on this, such as former Senator Connie 
Mack and others who would probably vehemently disagree with 
the--this administration's position?
    Mr. Allen. We are aware that the position the 
administration has taken is based upon the concern for--as the 
bills presented here today point out, and that is, is that 
there are no therapies that have been developed in the area 
that rely upon embryonic--rely upon pre-natal cloned cells.
    That point has not been taken, and it does not take away 
all the other therapies, all the other research that is ongoing 
to provide for the cures that you are talking about. We believe 
that there is no boundaries that have been established for the 
vacuum that is created.
    And if we allow and say that we support the use of cloned 
cells for that purpose, if we say that we support that, that 
opens up the----
    Mr. Ganske. Is it this administration's position that the 
FDA currently has the authority, then, to stop this procedure?
    Mr. Allen. While we believe that that is not necessary for 
this discussion, that position to address this, because under 
the legislation, particularly the Weldon-Stupak bill, it 
alleviates the need to arrive at that position because it bans 
both reproductive and research in those areas.
    Mr. Ganske. Do you think--but do you think the FDA has the 
authority to stop this now?
    Mr. Allen. I cannot give you a personal opinion on that. 
The administration, certainly the FDA, can speak to that 
specifically. Dr. Koon has spoken to that in the past, and I 
believe she is prepared to do so if----
    Mr. Ganske. Is the FDA making plans, then, to go into 
private laboratories to stop this type of research?
    Mr. Allen. Those plans are not underway at this time. That 
is not the----
    Mr. Ganske. But consistent with the administration's 
statement here that that would be--I mean, that would be 
consistent with this administration's statement.
    Mr. Allen. Upon the passage of the legislation, this 
administration would be prepared to work with the committee to 
implement the law to the full effect, according to the 
regulations that are provided.
    And any other--any further clarifications of all that would 
be necessary, we would be willing to seek that from the 
Congress.
    Mr. Ganske. Thank you, Mr. Chairman.
    Mr. Bilirakis. Mr. Stupak to inquire?
    Mr. Stupak. Thank you, Mr. Chairman. Mr. Allen, I would 
like you to clarify a statement you made regarding tissue-based 
therapies. You and the administration only object to tissue-
based therapies derived from cloned human embryos. Is that 
correct?
    Mr. Allen. I am sorry, I could not hear.
    Mr. Stupak. Sure. The administration, and you representing 
the administration, only object to tissue-based therapies 
derived from cloned human embryos, correct?
    Mr. Allen. That is correct.
    Mr. Stupak. In fact, our bill specifically says, is it your 
understanding, that we do not restrict areas of scientific 
research in the use of nuclear transfer or other cloning 
techniques to produce molecules, DNA, cells, other than human 
embryos, tissues, organs, plants, or animals, other than human 
beings. Is that correct?
    Mr. Allen. That is correct.
    Mr. Stupak. And so, some of the questions like the 
statement Mr. Strickland made, and even the question Mr. 
Deutsch asked, what if, our bill also, in this last part 
sentence of the Congress, also says if further therapies or 
research becomes available, they could always come back before 
the legislative body and say we need some relief in this area 
as we are doing this research.
    We leave it to the scientists to tell us when to come back, 
and not just a prohibition. Is that your understanding?
    Mr. Allen. That is our understanding. In fact, for those 
two reasons, the section--subsection (d), the scientific 
research, where it makes very clear what this--this bill not 
forescribe, make it a reason why we believe that those 
therapies can continue, those efforts of research continue, and 
why the administration believes that it is appropriate to speak 
very strongly on what we do prohibit and support.
    Furthermore, we believe that the--the ability here for 
science does change. And if the science demonstrates that 
embryonic cloning is ethicacious, safe, and effective, there is 
an opportunity again, a safety clause here, that allows for 
review.
    And we believe that that also is an appropriate way to 
address the issue.
    Mr. Stupak. And the administration, it does not object to 
other forms of tissue replication or cell-based therapies, do 
they?
    Mr. Allen. No.
    Mr. Stupak. Pardon?
    Mr. Allen. No, we don't.
    Mr. Stupak. Okay. Are there any therapies, medical uses 
from cloning, even stem cells, in existence right now?
    Mr. Allen. We are not aware of any, no.
    Mr. Stupak. Okay. Thank you, Mr. Chairman, and I yield 
back.
    Mr. Bilirakis. I thank the gentleman. Dr. Norwood?
    Mr. Norwood. Mr. Allen, I am going to basically ask you to 
repeat yourself. I am only going to ask you two questions, and 
I want you to take plenty of time and give us a lengthy, clear-
cut answer. Does the administration support the Greenwood bill?
    Mr. Allen. We do not support the Greenwood bill because it 
does allow for research cloning. So, we do not support the 
Greenwood bill.
    Mr. Norwood. And is that the only reason?
    Mr. Allen. That is principally a reason. There are other 
reasons that we would want to look at--again, there are 
technical issues that we would need to address. I could 
highlight a couple of those: one, just the impact that it has 
on inconsistency among the States.
    It was stated earlier that a number of States have already 
acted in this area. The Greenwood bill preempts much of what 
those--what other States may do in those areas. And so, that 
would cause for some concerns.
    Some States that have varying degrees of how these address 
these issues--by preempting some and not others, it does create 
for some interpretation issues, as well as enforcement issues 
for the Department.
    Those would be principally some of the areas that we would 
have concerns about.
    Mr. Norwood. All right. To your knowledge--and the 
Congressman can speak for himself; but to your knowledge, has 
Congressman Greenwood worked with the administration to see if 
he could--if the two of you could work this out?
    Mr. Allen. To my knowledge--again, personally, I have only 
been on-board for a very short while. So, therefore, I am not 
aware of--and we would be certainly willing to sit down with 
Congressman Greenwood to talk about that and address many of 
these issues.
    But I think on the policy issue, the policy decision 
about--which the administration is very clear on, is the 
prohibition against all forms of cloning.
    Mr. Norwood. I will yield.
    Mr. Greenwood. Thank you, gentleman, for yielding. Here is 
a problem we have, Mr. Allen. We all agree, the administration, 
everybody in this room, everybody probably--practically 
everyone in the Congress, we need to ban human reproductive 
cloning.
    And if we don't do something legislatively, we may very 
well, very soon, be in a position where people are actually 
trying to do something that we all agree is very unsafe and 
very unethical, and that is to try to create human beings 
through cloning.
    There is huge disagreement on the second part of this, the 
therapeutic part. And I would predict, I think accurately, that 
we are never going to get a Weldon-style bill through the U.S. 
Senate.
    There was precedent for that when the Republicans were in 
control, and you are certainly not going to get a Weldon-type 
bill that bans the therapeutic cloning through the Senate.
    So, now we are in a position that we are going to fail, as 
a Nation, to ban reproductive cloning because we can't get past 
this issue of therapeutic cloning. And what I have been trying 
to argue is, if we want to prohibit therapeutic--the 
reproductive cloning, let us do it, which is what our bill 
does, and leave to another day the debate about he therapeutic 
cloning. And I guess my question----
    Mr. Norwood. Excuse me, I have got to reclaim my time to 
get to the next question.
    Mr. Greenwood. Okay, all right. Well, let me----
    Mr. Norwood. But you----
    Mr. Greenwood. I thank the gentleman for yielding.
    Mr. Norwood. Mr. Allen, does the administration support the 
Weldon-Stupak bill?
    Mr. Allen. The administration does not actively endorse the 
Weldon-Stupak bill for the reasons I have cited. Also, there 
are some areas that we believe that are technical questions 
that----
    Mr. Norwood. Well, speak up. What are those areas?
    Mr. Norwood. A couple of those areas, for example, is in 
the bill itself--one of the concerns is within the definition 
section, define of the term ``asexual reproduction.'' There 
were some concerns about the ability to maneuver around the 
word of what--without defining specifically what asexual 
reproduction is would be one area that we would certainly want 
to work with and clarify.
    The issue of importation, banning of the importation of--I 
believe--I am not sure exactly--Congressman Waxman raised the 
question about that. What would actually be banned? Will we be 
banning--if a child was born that was the product of cloning, 
would we be ban that?
    Also, the meaning of ``nuclear material'' is another 
question. I know that--what we think the intent of the bill is, 
but we would want to seek clarification of what nuclear 
material would be. Those are just a few areas that----
    Mr. Norwood. And well, I am in the cautionary, so just 
quickly and last, does the White House believe we need to 
legislate this year on this issue?
    Mr. Allen. The White House has not taken a position as far 
as legislating. We do believe that there is significant concern 
and significant harm based upon statements that have been made, 
whether real or fictitious, however close they may be.
    But we do believe that there is a significant concern that 
if we do not legislate in this area, that we could move very 
quickly down this track, whether it is for research purposes 
that could ultimately lead to reproductive purposes for 
cloning. So, we would say yes, we believe that there needs to 
be some action in this area this year.
    Mr. Norwood. I suspect we all agree with that. So, I hope 
you will encourage the White House crew to work with Mr. 
Weldon, and Mr. Stupak, and Mr. Greenwood, because we need to 
get this done.
    Mr. Allen. We will do that.
    Mr. Bilirakis. Mr. Pitts to inquire?
    Mr. Pitts. Thank you, Mr. Chairman. Secretary Allen, to my 
knowledge, three people: a Dr. Bosalier, Dr. Okarma, and Dr. 
Zabos have informed the committee that they all intend to clone 
human embryos.
    How has the FDA, or has the FDA, used their authority to 
monitor and regulate the activities of these researchers who 
intend to clone human embryos, two of whom, we are told, intend 
to implant?
    Mr. Allen. Without discussion--discussing or disclosing the 
FDA's techniques for investigation, we will say that we have 
taken these claims very seriously. And in some instances, 
contact has been made with the principals who said that they 
intend to do this.
    And we have discussed very carefully with them the 
requirements for such--beginning of such research. For example, 
the FDA requires that an investigational new drug application 
be filed by anyone or any entity that seeks to begin moving 
down this track. None have been filed.
    And thereby, we would notify and work with any of these 
individuals to let them know that that is a requirement, and 
that FDA would seek to enforce in that area.
    Mr. Pitts. I have an enforcement question. The FDA says 
they have the power to regulate the entire cloning process if 
the intent is to implant the cloned embryo into a surrogate 
mother.
    If FDA officials showed up at a laboratory, how could they 
distinguish between those cloned embryos destined for 
destruction by experimentation and those destined for 
implantation?
    Mr. Allen. That is an excellent question. And that is the 
reason why we believe that you must ban all, because you cannot 
make the distinction based upon intent. And whose intent are we 
referring to? Is it the intent of the one who created the clone 
through the process, or is it the intent of that individual who 
seeks to implant?
    Those are questions that must be worked out. And the FDA 
does not have the ability to make that discern--to discern 
that.
    Mr. Pitts. And one final question: on the bottom of page 2 
of your written testimony, you state, ``Additional concerns 
beyond the scope of FDA's role remain to be resolved, 
especially the broad social and ethical implications of cloning 
human beings, such as whether the use of human somatic cell 
nuclear transfer is morally acceptable under any 
circumstance.''
    Yet, your written testimony also states that, ``The 
administration opposes the use of human somatic cell nuclear 
transfer cloning techniques either to assist human reproduction 
or develop cell or tissue-based therapies.''
    That sounds to me as if that additional concern has been 
resolved by the administration. Am I correct?
    Mr. Allen. If I understand your question, the answer will 
be yes.
    Mr. Pitts. Okay, thank you, Mr. Chairman.
    Mr. Greenwood. Would the gentleman yield? Would the 
gentleman yield?
    Mr. Pitts. I will be happy to yield.
    Mr. Greenwood. Mr. Allen, if you came into a laboratory 
where this kind of research with somatic transfer was taking 
place, and you find on that laboratory table an egg that has 
had its genetic material transferred and a gun, how do you 
know--how do you--isn't the question of what the intent is the 
same for--in both instances?
    In other words, why not confiscate the gun and the cells 
because we don't know what the intent is of the user, whether 
the user intends to commit a crime with either one of those?
    It seems to me to be a very strikingly absurd position to 
say that in most instances, we respect the freedom of 
individuals to say that they have not committed a crime until 
they commit one. But in this instance, we want to stop them 
before because we do not understand what their intent is. What 
is the distinction there?
    Mr. Allen. Mr. Greenwood, I think it really raises the 
question about the intent language in your bill, specifically. 
And I think that that--I would turn that back to you and say 
that that is the concern that we have with your bill, is that 
it requires us to figure that out.
    And we have no way of doing that, top figure out whether a 
set of embryos are set for research purposes as opposed to 
being shipped and ultimately used for reproductive purposes.
    And the way to deal with it at this point is to ban both.
    Mr. Greenwood. Thank you, gentleman, for yielding.
    Mr. Bilirakis. I thank the gentleman, as a courtesy to a 
member of the full committee--well, no, I see that Mr. Green 
has now appeared. Mr. Green to inquire?
    Mr. Green. Yes, Mr. Chair. And I know we have a vote on, so 
I will be as quick as I can.
    Mr. Bilirakis. No, it is a recess.
    Mr. Green. Oh, okay, that is even better.
    Mr. Bilirakis. You still can be brief though.
    Mr. Green. Oh, okay, I will try and be brief, then, Mr. 
Chairman.
    Mr. Allen, your statement that the administration opposes 
somatic cell nuclear transfer for both therapeutic and 
reproductive purposes, but that it supports other approaches to 
development of these therapies such as research of genes, 
cells, or tissues from humans or animals consistent with 
current law--can you elaborate on the phrase ``consistent with 
current law''?
    Current law, for example, provides that Federal funding is 
available for research that uses embryonic stem cells. Are we 
to take from your statement the administration has now settled 
on its position on the matter? I guess current law is a----
    Mr. Allen. If I understand your question referring to stem 
cell research, the President will make a statement. He will 
make a decision as to the administration's position on stem 
cell research, embryonic stem cell research.
    That is not my place to do that. And he will make that 
statement, and it will be a very clear statement about that. 
What we are focusing on here is solely on the issue of cloning 
and using cloned human embryos for the purpose, whether it be 
for stem cell research or for reproductive purposes as well.
    So, it is a very narrow review. The issue of stem cell 
research will be discussed at a later date by the President, 
himself.
    Mr. Green. Okay, but does the administration--the 
administration does not support the use of any kind of research 
into human cloning for stem cell research, or is that something 
we are going to wait for the Secretary?
    Mr. Allen. The answer would be--if it uses human cloning, 
then the answer would be no.
    Mr. Green. Okay. You indicate that the concerns of scope of 
the FDA role remain to be resolved, such as whether the use of 
human somatic cell nuclear transfer is morally acceptable in 
any circumstances.
    Elsewhere in your statement, you clearly support a total 
ban on SCNT. Yet, this argued statement I just quoted implied 
that you are not sure, that the administration's position could 
change.
    Under what circumstance, if any, would the administration 
support therapeutic use of human somatic cell nuclear transfer?
    Mr. Allen. We believe that it is a very responsible 
position to say that we should ban this entire area at this 
point. Science may advance. There may be therapies that can be 
developed based first upon animal cloning techniques to see 
whether they are ethicacious in humans.
    Thereby, one of the reasons why the Weldon-Stupak bill, we 
believe, has some advantages to it is that it does allow for a 
review period after a scientific panel has looked at this 
entire area.
    And for that reason, we believe that--that it is important 
that we remain flexible on what might be without being absolute 
in that position.
    Mr. Green. I don't think I have anything else. Thank you, 
Mr. Chairman; I yield back.
    Mr. Bilirakis. I thank the gentleman. Ms. Cubin to inquire?
    Ms. Cubin. I don't have anything.
    Mr. Bilirakis. Thank you. Mr. Brown, do you have----
    Mr. Brown. No, I am not ready yet.
    Mr. Bilirakis. We are all finished up with the exception of 
extending courtesy to a member of the full committee, Ms. 
DeGette.
    Ms. DeGette. Thank you so much, Mr. Chairman. And again, I 
appreciate your courtesy. Mr. Allen, you had testified, I 
believe in response to Mr. Greenwood's question, that the way 
the administration developed its position on this issue was you 
have experts internally, and you also consulted the NIH. Is 
that correct?
    Mr. Allen. The NIH would be considered internally as well. 
Our position is----
    Ms. DeGette. Okay, but you did consult the NIH?
    Mr. Allen. The NIH would certainly be a part of the 
Department----
    Ms. DeGette. And were----
    Mr. Allen. [continuing] and their opinions would be----
    Ms. DeGette. [continuing] they consulted here, sir?
    Mr. Allen. Their opinions would certainly have weighed into 
where we are, yes.
    Ms. DeGette. Okay, because the reason I ask is on March 26, 
we received a letter from Ruth Kirchstein, who is the acting 
Director of the NIH, who said, ``NIH, itself, lacks experience 
in this area of cloning research,`` and they declined to 
testify in the March hearing we had in the Oversight and 
Investigations Subcommittee because they didn't have any 
experience.
    Mr. Chairman, I would ask unanimous consent to submit that 
letter for the record.
    Mr. Allen. And I appreciate that, but that is not 
inconsistent with what I have----
    Ms. DeGette. Okay, thank you----
    Mr. Allen. [continuing] said in that we are working with--
--
    Ms. DeGette. [continuing] sir, I just--I just want----
    Mr. Allen. [continuing] the NIH.
    Ms. DeGette. [continuing] the record to be clear the NIH 
does not feel it has expertise in this area. Now, let me ask 
you, Mr. Allen, you had testified, I believe in response to Mr. 
Pitts' questioning, that you go into these labs, you see these 
cells sitting here, and you can't really tell what they are 
for. So then, all this research might as well be banned.
    Is it the administration's position that in vitro 
fertilization should be banned as well since, when we walk into 
labs, if we see fertilized eggs, we don't know what is going to 
happen with those?
    Mr. Allen. The answer would be no.
    Ms. DeGette. Why not?
    Mr. Allen. Because in vitro fertilization--there is a 
distinction between the two, and I think I explained a little 
earlier----
    Ms. DeGette. Well, I know the distinction between the two, 
but here is my concern. If you walk into a research lab, and 
you see a bunch of fertilized eggs, how are you going to know 
what the purpose is? Is the purpose going to be to take the--to 
take the DNA out and to clone cells, or is the purpose going to 
be to go in and implant those for in vitro fertilization?
    How are you going to know the difference when you see that 
matter in a research lab?
    Mr. Allen. Well, we don't know the difference when we see 
that matter in----
    Ms. DeGette. Okay.
    Mr. Allen. [continuing] the research lab.
    Ms. DeGette. So, how--how is it that you are going to allow 
one but not the other?
    Mr. Allen. In vitro fertilization is something that is 
already regulated under FDA. And therefore, the protocols, the 
processes, and procedures would have already been considered by 
FDA, and have been reviewed. And this certainly----
    Ms. DeGette. Well, but the--I don't suppose it has been 
reviewed by FDA under the Weldon-Stupak bill or the Greenwood 
bill, right?
    Mr. Allen. That is correct. And in both of those 
circumstances, that protocol would be developed upon passage--
--
    Ms. DeGette. Well, how--do the----
    Mr. Allen. [continuing] of the legislation.
    Ms. DeGette. [continuing] little cells have nametags? I 
mean, how are you going to know? I don't--I am not meaning to 
be flip here, but you walk into a research lab; how are you 
going to know the purpose of those fertilized eggs?
    Mr. Allen. All the more reason why, in this area of 
cloning, when we are talking about cloning cells--one point 
that I think is important to make, what this legislation again 
does not prohibit, it does not prohibit in vitro fertilization. 
It does not prohibit twinning of cells for the purpose of 
implantation.
    Ms. DeGette. Okay, but those----
    Mr. Allen. But those are issues that we----
    Ms. DeGette. But they can't be--the difference cannot be 
visually determined. Would that be correct?
    Mr. Allen. I am not the scientist here. I would imagine 
that you are correct, that it is not--that is correct.
    Ms. DeGette. Okay, thank you. Now, I have another question. 
I am sorry, they only give us 5 minutes, and I am already 
pushing my----
    Mr. Allen. But I assume you want me to give you full 
answers and complete answers so that it is not incorrect for 
the record. So, if you would----
    Ms. DeGette. Let me ask you one more question, which is 
that in the Weldon-Stupak bill, and you just talked about this 
for a moment when Mr. Green was questioning you, that bill says 
that the scientific community can come back if they feel like 
cloning research would be necessary for some non-human 
reproductive purpose, correct?
    I think it says the scientific community can come back and 
request----
    Mr. Allen. No, actually, it requires the scientific--it 
requires a report to be issued to the Secretary and the 
President that will already affirmatively address that in a 5-
year period.
    Ms. DeGette. Okay.
    Mr. Allen. Prior to that time----
    Ms. DeGette. Okay, what----
    Mr. Allen. Prior to that time----
    Ms. DeGette. Uh-huh.
    Mr. Allen. [continuing] if there is--if there are advances 
that are made known, certainly the Department would be looking 
at that as we are ongoing in this area.
    Ms. DeGette. Right. Here is my question to you: if we ban 
the research, how are they going to be able to make a report? 
If they can't do the research, how are they going to be able to 
tell you what the benefits of this type of research would be?
    Mr. Allen. Very simply, in that they can do the research in 
other mammals.
    Ms. DeGette. But that is not----
    Mr. Allen. They can do the research----
    Ms. DeGette. But that is not this exact type of research, 
right?
    Mr. Allen. Correct, it is not because----
    Ms. DeGette. Okay.
    Mr. Allen. [continuing] this is an area that we are talking 
about banning.
    Ms. DeGette. So, you are saying they----
    Mr. Allen. Can I actually----
    Ms. DeGette. [continuing] can transfer animals----
    Mr. Allen. [continuing] just finish an answer--complete the 
question because I want to----
    Ms. DeGette. Go ahead.
    Mr. Allen. [continuing] give you a complete answer. And I 
think that--that the record is entitled to see that----
    Ms. DeGette. Go ahead, finish.
    Mr. Allen. [continuing] very clear. Is the answer is very 
clear; the research, the language of the Weldon-Stupak bill 
allows for ongoing research and consideration of the scientific 
ethicacy of all of these areas that we are talking about.
    Currently, what we are talking about is that you can do 
this in every other area, but there is no indication that there 
are therapies that have been developed, nor should--the 
position of the administration is nor should they be at this 
point, absent an indication that they would be both safe, 
ethicacious, and that there are moral, legal boundaries that 
are put around that research.
    Ms. DeGette. Thank you.
    Mr. Bilirakis. The gentlelady's time has expired. Mr. 
Allen, the in vitro fertilization would ordinarily take place 
in a research lab?
    Mr. Allen. Not likely.
    Mr. Bilirakis. Ordinarily, not likely?
    Mr. Allen. Usually, it takes place in a fertility clinic.
    Mr. Bilirakis. Right. So, ordinarily, they wouldn't be side 
by side on a table, or a group of tables in a laboratory?
    Mr. Allen. That is correct, Mr. Chairman.
    Mr. Bilirakis. Mr. Burr to inquire.
    Mr. Burr. Am I the last, Mr. Chairman?
    Mr. Bilirakis. You are not the last; Mr. Brown will be the 
last.
    Mr. Burr. Could I pass to Mr. Brown and come back to me?
    Mr. Bilirakis. If Mr. Brown is willing to----
    Mr. Burr. I am still trying to get caught up on the----
    Mr. Bilirakis. [continuing] accept that pass.
    Mr. Brown. Mr. Burr, I probably could.
    Mr. Bilirakis. No, no----
    Mr. Burr. I will say some nice things about Mr. Brown.
    Mr. Bilirakis. [continuing] discussion on tax cuts now.
    Mr. Brown. Well, Mr. Chairman, since you brought up the tax 
cut and you always seem to need to do that----
    Those of you that don't come to this hearing, don't get 
that. It is really rather a stupid inside joke, but 
nonetheless. I yield my 5 minutes actually to Ms. DeGette. 
Thanks.
    Ms. DeGette. Thank you, Mr. Chairman. Just a couple more 
questions.
    Mr. Allen. Certainly.
    Ms. DeGette. You had, I think, testified in response to 
someone's question that we have not yet seen any kind of 
scientific--direct scientific result from human stem cell 
research, which is accurate, I believe, right?
    Mr. Allen. I don't think I--that is not correct.
    Ms. DeGette. Okay.
    Mr. Allen. We do know that there were use of human stem 
cell research in some of the Parkinson's and Alzheimers cases 
that were absolutely disastrous. So, we do have some evidence 
of their use.
    Ms. DeGette. But we also have some evidence from Canada, 
don't we, about the use of stem cell research in Type-1 
diabetes?
    Mr. Allen. I will have to defer to you on that. I have not 
seen that.
    Ms. DeGette. Okay, well, I will let you know because I am 
the co-chair of the Congressional Diabetes Caucus, that we have 
seen some promising----
    Mr. Allen. Oh, I wasn't----
    Ms. DeGette. [continuing] stem cell research in Canada. And 
also, in April, scientists at the National Institutes of Health 
used mouse embryonic stem cells to generate insulin-producing 
organs resembling the islets of the pancreas. Were you aware of 
that research?
    Mr. Allen. I was aware of that.
    Ms. DeGette. So, I think you would agree with me we are 
seeing some very promising stem cell research coming out, would 
you not?
    Mr. Allen. Actually, I think the two examples you posited, 
it demonstrates that use in other mammals, that it is been very 
promising. But in use of humans, it has not been.
    Ms. DeGette. Well, actually, there has been some use in 
humans in other countries and----
    Mr. Allen. Those two examples you have posited that are--
that is what I am going on.
    Ms. DeGette. Yeah.
    Mr. Allen. I am not the scientist.
    Ms. DeGette. And actually, I think you were the one that 
testified that mammal research is often transferrable to 
humans, which is why we do research on mammals.
    Mr. Allen. Which is why we should perfect mammal research 
prior to experimentation on humans.
    Ms. DeGette. I don't think anybody would disagree with 
that, certainly with cloning. Let me ask you another question, 
which is, as I--what is the administration's position on 
products which may be developed by use of this type of cloning 
process, perhaps developed overseas?
    Let us say, for example, some kind of products that 
dramatically, positively impact Parkinson's patients are 
developed, would it be the administration's position that those 
products should be banned in the United States?
    Mr. Allen. They would be subjected to the same protocol 
that other products would be subjected to by the FDA before 
they are allowed to be--allowed to be utilized in the United 
States. We do that with other areas. We have done it in the 
area of----
    Ms. DeGette. Sure.
    Mr. Allen. [continuing] cancer, so it would be the 
similar----
    Ms. DeGette. Well, as I understand the Weldon-Stupak bill, 
products developed with this type of cloned material would 
banned. So, would the administration support that part of the--
that bill?
    Mr. Allen. That is one of the areas that I said that we 
would need to work out with technical assistance with the bill 
patrons to consider and see what impact it has on other areas 
of what we do approve of and support.
    Ms. DeGette. Now, getting back to your point about FDA 
approval, is--I know safety and ethicacy are two of the 
criteria used by the FDA in deciding whether or not to approve 
a drug.
    For example, if we had a Parkinson's drug that was 
developed overseas with use of these cloned techniques, would--
I would assume the FDA will use those same standards in 
deciding whether to approve the drug, unless it was banned, 
right?
    Mr. Allen. I would--if I understand your question 
correctly, I would say that is correct. And it goes back to 
your prior question. That is why we believe that having a 
period--an absolute ban on that is imperative.
    However, the administration is not saying that we are not 
willing to look at--look at what has been done. And that is 
not----
    Ms. DeGette. I am sorry----
    Mr. Allen. [continuing] inconsistent.
    Ms. DeGette. [continuing] I am kind of confused because you 
are--on the one hand, you are saying that we should have a ban 
on these products. But then, you are saying, well, we need to 
look at it. I don't know what you mean by that.
    Mr. Allen. What I mean by that is very clear. I think it is 
very imperative, and the administration believes it is 
imperative, that we take a position, a very clear position, on 
what we believe is----
    Ms. DeGette. Yeah, I get that, but what is that----
    Mr. Allen. You got that part.
    Ms. DeGette. [continuing] clear position? That is not what 
I get.
    Mr. Allen. Okay, the clear position is that the 
administration is opposed to the use of stem cell nuclear 
transfer cloning for research or reproductive purposes.
    Ms. DeGette. Well, obviously, the reproductive purposes, we 
all----
    Mr. Allen. Research or----
    Ms. DeGette. [continuing] agree on that.
    Mr. Allen. [continuing] reproductive.
    Ms. DeGette. Now, on the research, let us say a drug is 
developed----
    Mr. Bilirakis. The gentlelady's time, or I should say the 
gentleman's time, is expired.
    Ms. DeGette. Thank you.
    Mr. Bilirakis. Mr. Burr to inquire?
    Mr. Burr. I thank the Chair's indulgence. Mr. Allen, tell 
me what the administration says to those folks around this 
country that potentially might be waiting for a breakthrough 
into the current research that is out there.
    Mr. Allen. Well, the administration's position would be 
that there are ample existing therapies and treatments, and 
very promising areas to address many of these areas--many of 
these concerns, whether it is for cancer, organ, bone marrow 
transplants. I saw an article in the paper this morning.
    And we believe that we should be very aggressive in 
pursuing, and very aggressive in supporting, that research.
    Mr. Burr. Is the research that is currently being done, are 
the scientists that are currently working on somatic cell 
nuclear transfer, are they wrong? Is there something there that 
HHS and this administration sees that says they won't be 
successful?
    Mr. Allen. We believe that there is something that the 
research, thus far--I think the discussion earlier was in the 
area of where we have seen some of this occur is in the stem 
cell research area where there was use of embryonic stem cells 
for Parkinson's and Alzheimers that had very deleterious 
effects on the individuals that the therapies were used on.
    In this area, we believe also that we need to be very 
careful, extremely careful, of going down that road because of 
the impact not only on the mother and child that may be 
produced as a result of cloning, but also the impact that it 
has on society. There are psychological; there are also moral--
--
    Mr. Burr. Is this a policy decision or is this a scientific 
decision?
    Mr. Allen. We believe that it is a policy decision that is 
based on the science. And that is why I think, contrary to 
the----
    Mr. Burr. Who made this decision?
    Mr. Allen. This is the decision of the President and the 
Secretary of Health----
    Mr. Burr. And they made----
    Mr. Allen. [continuing] and Human Services.
    Mr. Burr. [continuing] that decision, when?
    Mr. Allen. I am here providing that position.
    Mr. Burr. I know you are here delivering the message today. 
When did they make the decision? When did you and the Secretary 
have a conversation relative to this decision?
    Mr. Allen. My conversation--again, I have been on-board all 
of 2 weeks, so I will have--I would have talked with the----
    Mr. Burr. Well, clearly, it must have----
    Mr. Allen. --Secretary during that time.
    Mr. Burr. [continuing] happened sometime in that period.
    Mr. Allen. So, it happened within that period. I cannot 
speak specifically for when the President made his mind up 
about this issue. I do know that----
    Mr. Burr. Do we condone----
    Mr. Allen. [continuing] when the----
    Mr. Burr. Do we condone the research that is currently 
going on in the U.K. as it relates to stem cell research?
    Mr. Allen. I am not here to comment on the efforts of the 
work that is done in other countries. We have a 
responsibility----
    Mr. Burr. Do we condone----
    Mr. Allen. [continuing] for what takes place in----
    Mr. Burr. If they were to--if they were to----
    Mr. Allen. If I may----
    Mr. Burr. [continuing] make legal----
    Mr. Allen. [continuing] Finish my----
    Mr. Burr. [continuing] human cloning, would we come out 
against that policy?
    Mr. Allen. Again, that is something that is left for the 
British Government and its citizens to decide what is in their 
best interest and what is----
    Mr. Burr. So, if they----
    Mr. Allen. [continuing] appropriate for them. It is not for 
us to decide.
    Mr. Burr. If they passed a law that made legal human 
cloning, we would not come out in this country in opposition to 
human cloning in the U.K.?
    Mr. Allen. Again, I see no reason why I should provide a 
position to comment on what the U.K. has done or is doing. I 
think it is imperative that, from our perspective, we look at 
what the United States does.
    The United States is a leader in the world, both morally--
serving as a moral force, as well as looking at science and the 
advancement of it. And we believe, at this time, that this the 
wrong-headed to----
    Mr. Burr. Would one conclude that the administration sees 
no scientific value out of additional research in stem cell 
nuclear transfer?
    Mr. Allen. That is incorrect.
    Mr. Burr. They do see promise?
    Mr. Allen. The administration believes that it is 
inappropriate at this time for us to proceed forward with 
research in this area.
    Mr. Burr. Do they see promise in this area, or do they see 
no promise?
    Mr. Allen. I am not sure that I can give you an either/or. 
I think that certainly----
    Mr. Burr. Well, it is a scientific question.
    Mr. Allen. [continuing] we believe that there is promise--
--
    Mr. Burr. [continuing] and I think you alluded to the 
fact----
    Mr. Allen. [continuing] we believe that there is scientific 
evidence----
    Mr. Burr. [continuing] that if cancer was----
    Mr. Allen. [continuing] that there is promise as we work 
within mammals and see the ethicacy there. The application to 
humans at that point is something that we would certainly need 
to look at and consider.
    That is, again, the reason why we believe that the Weldon-
Stupak bill provides for the vehicle through which further 
analysis, further review, and further comments to be made on 
that area.
    Mr. Burr. Mr. Chairman, I am sorry that I wasn't here for 
the full discussion. And I am sure I will have follow-up 
questions. I would ask unanimous consent that we be allowed to 
send those directly to the Agency?
    Mr. Bilirakis. Without objection, that is the case. I think 
that ends this portion of the hearing, Mr. Allen. We appreciate 
your being here. Obviously, there will be questions that will 
be forwarded to you. We would request timely responses.
    It is a tough issue, and I am not sure that anybody has 
really counted votes in terms of either piece of legislation as 
they may be re-molded. But I would like to think that we are 
intent on moving, at some point, on this issue.
    So, please take a little bit of leadership on it, and work 
with the principals.
    Mr. Allen. Certainly, we--and we look forward to working 
with the members. Thank you.
    Mr. Bilirakis. Thank you. Thank you very much, sir. The 
second panel consists of Mr. Thomas Okarma, President of the 
Geron Corporation, here on behalf of the bio-tech industry; Dr. 
Leon Kass, Addie Clark Harding Professor of Social Thought and 
the College from the University of Chicago; Mr. Louis Guenin, 
lecturer on ethics and science with the Department of 
Microbiology and Molecular Genetics, Harvard Medical School; 
Dr. Stuart Newman, Professor of Cell Biology and Anatomy for 
the Department of Cell Biology and Anatomy, New York Medical 
College; Mr. Dan Perry, Executive Director of Alliance--with 
the Alliance for Aging Research; Ms. Judy Norsigian, Executive 
Director of the Boston Women's Health Book Collective-
Collective, associated with Boston University, Boston 
University School of Public Health; Mr. Richard Doerflinger, 
Associate Director for Policy Development with the National 
Conference of Catholic Bishops; and Mr. Francis Fukuyama, Omer 
L. and Nancy Hirst Professor of Public Policy for the School of 
Public Policy at George Mason University.
    Lady and--where is Ms. Norsigian? Ms. Norsigian and 
gentlemen, welcome. Thank you so much for being here. You have 
had to sit through 2 hours of this. But believe me, that is not 
really a long period of time when you take into consideration 
how we function up here and the usual interruptions we have 
running in for votes.
    But we do have a little bit of a break in the sense that 
there is a recess on the floor. So, hopefully, we can go 
uninterrupted, for a short period of time anyhow, and maybe 
complete it.
    Your written statement is a part of the record. We will set 
the clock at 5 minutes. Hopefully, you can complete your 
statement within that period of time. If you go over for a 
short period of time, I won't call you on it. But I would 
appreciate it if you would compliment and supplement your 
written statement.
    We will start off with Mr. Okarma. Please proceed, sir.

 STATEMENTS OF THOMAS OKARMA, PRESIDENT, GERON CORPORATION, ON 
 BEHALF OF BIOTECHNOLOGY INDUSTRY ORGANIZATION; LEON R. KASS, 
    ADDIE CLARK HARDING PROFESSOR OF SOCIAL THOUGHT AND THE 
 COLLEGE, UNIVERSITY OF CHICAGO; LOUIS M. GUENIN, LECTURER ON 
  ETHICS IN SCIENCE, DEPARTMENT OF MICROBIOLOGY AND MOLECULAR 
 GENETICS, HARVARD MEDICAL SCHOOL; STUART A. NEWMAN, PROFESSOR 
  OF CELL BIOLOGY AND ANATOMY, DEPARTMENT OF CELL BIOLOGY AND 
  ANATOMY, NEW YORK MEDICAL COLLEGE; DANIEL PERRY, EXECUTIVE 
    DIRECTOR, ALLIANCE FOR AGING RESEARCH; JUDY NORSIGIAN, 
  EXECUTIVE DIRECTOR, BOSTON WOMEN'S HEALTH BOOK COLLECTIVE, 
     BOSTON UNIVERSITY SCHOOL OF PUBLIC HEALTH; RICHARD M. 
    DOERFLINGER, ASSOCIATE DIRECTOR FOR POLICY DEVELOPMENT, 
NATIONAL CONFERENCE OF CATHOLIC BISHOPS; AND FRANCIS FUKUYAMA, 
OMER L. AND NANCY HIRST PROFESSOR OF PUBLIC POLICY, THE SCHOOL 
           OF PUBLIC POLICY, GEORGE MASON UNIVERSITY

    Mr. Okarma. Good afternoon. I am Tom Okarma, President and 
CEO of Geron Corporation in Menlo Park, California. Geron is a 
biopharmaceutical company focusing on discovering, developing, 
and commercializing therapeutic and diagnostic products in 
oncology, drug discovery and regenerative medicine.
    Today, I am testifying on behalf of my company and the 
Biotechnology Industry Organization. BIO represents more than 
950 biotechnology companies, academic institutions, State bio-
tech centers, and related organizations in all 50 U.S. States 
and 33 other nations.
    Mr. Chairman and members of the subcommittee, thank you for 
the opportunity to testify today at this important meeting on 
cloning. In my testimony today, I would like to make three 
points.
    First, Geron Corporation, BIO, and the overwhelming portion 
of scientists and physicians oppose human reproductive cloning 
of human beings.
    Second, however in our shared zeal to prevent reproductive 
cloning, we must not prevent research on tissue cloning, which 
is fundamental to enable the development of safe and effective 
cellular transplant patient therapies that could, and we 
predict will, revolutionize medicine.
    Third, the objective of the research is to develop a 
scalable process to enable the direct conversion of a somatic 
or body cell into a pluripotent cell without consuming oocytes 
and without generating embryos.
    Such a process would allow the generation of transplantable 
replacement cells that would not be rejected by the immune 
system. First, ban reproductive cloning. It would be extremely 
dangerous to attempt human reproductive cloning. It took over 
270 attempts before Dolly was successfully cloned.
    In fact, in most animals, reproductive cloning is no better 
than a three to 5 percent success rate; that is, very few of 
the cloned animal embryos implanted in a surrogate mother 
animal survive.
    The others either die in utero, sometimes at very late 
stages of pregnancy, or die soon after birth. It is simply 
unacceptable to subject humans to those risks.
    To allow human reproductive cloning would be irresponsible. 
Worse yet, it could lead to a back-lash that would stifle the 
numerous beneficial applications of therapeutic cloning 
technology, some of which I will now describe.
    It is critical, therefore, to distinguish the use of 
cloning technology to create a new human beings from other 
appropriate and important uses of the technology, such as 
cloning specific human cells, genes, and tissues that do not 
and cannot lead to a cloned human being.
    The full potential of this technology comes from its use in 
regenerative medicine. Many diseases result in the disruption 
of cellular function or the destruction of tissue. Heart 
attacks, stroke, diabetes, are all examples of common 
conditions in which critical cells are lost to disease.
    Today's medicine is completely unable to restore this loss 
of function. Regenerative medicine is a new therapeutic 
paradigm that holds the potential to cause an individual's 
currently malfunctioning cells to begin to function properly 
again, or even to replace dead or irreparably damaged cells 
with fresh, healthy ones, thereby restoring organ function.
    The goal of the research is to produce transplantable cells 
that provide these benefits without triggering immune rejection 
of the transplanted cells. This could be used to treat numerous 
diseases such as diabetes, heart disease, stroke, Parkinson's 
disease, and spinal cord injury.
    For example, today, we have learned how to turn 
undifferentiated human pluripotent stem cells into human 
neurons, human liver cells, and human heart muscle cells. These 
human replacement cells function normally in vitro, raising the 
possibility for their application in the treatment of 
devastating diseases affecting these tissue types.
    This would, for example, allow patients with heart disease 
to receive new heart muscle cells that would improve heart 
function. Cellular cloning techniques are a critical and 
necessary step in the production of sufficient quantities of 
vigorous replacement cells for the clinical treatment of 
patients.
    Somatic cell nuclear transfer research is essential if we 
are to achieve our goals in regenerative medicine. We must 
understand the biological properties of the egg cell and the 
transferred nucleus that cause a differentiated cell to turn 
into a pluripotent one.
    This process is called ``reprogramming,'' and we are still 
not sure how it works, which is why we need to perform the 
research.
    At Geron, our aim is to harness and therapeutically apply 
the power of this biology. Once we fully understand 
reprogramming, we will be able to develop specific cells for 
transplantation without immune rejection.
    We will do that by taking a differentiated cell from a 
particular patient, reprogramming it back to form a pluripotent 
cell from which we can produce the differentiated cells we need 
for transplantation back into that individual.
    By using the patient's own cells as starting material, we 
will avoid complications due to immune response rejection.
    However, this is precisely the research that would be 
banned by the Weldon bill. Because the Weldon bill does not 
distinguish between reproductive cloning and the use of cloning 
for research purposes, it will cutoff this work and prevent its 
therapeutic applications from reaching patients.
    In contrast, the bipartisan bill introduced by 
Representatives Greenwood and Deutsch and others bans 
reproductive cloning appropriately, but allows the continuation 
of research.
    BIO supports Greenwood-Deutsch because it strikes the 
appropriate balance between prohibiting acts that are unsafe 
and unethical, while promoting vital medical research.
    Last, it is critical to emphasize that once we understand 
the molecular biology of reprogramming, we will no longer need 
to use egg cells or to create blastocysts. The commercial 
process envisioned would transform a somatic cell, such as a 
skin cell, into a pluripotent cell directly, without the use of 
oocytes or the creation of blastocysts.
    Moreover, understanding the biology of reprogramming is a 
critical step to improve the usefulness of so-called adult stem 
cells. Ironically, the Weldon bill will also be a set-back for 
adult stem cell research.
    In conclusion, Mr. Chairman, human reproductive cloning 
remains unsafe, and the ethical issues it raises have not been 
reasonably resolved. It should be prohibited.
    However, as Congress seeks to outlaw reproductive cloning, 
it must not write legislation that will stop research using 
cloning technology.
    Unfortunately, the Weldon bill fails that test. Simply put, 
enactment of the Weldon bill will stop critical therapeutic 
research in its tracks. Only Greenwood-Deutsch strikes the 
right balance. Thank you.
    [The prepared statement of Thomas Okarma follows:]
     Prepared Statement of Thomas Okarma, President and CEO, Geron 
    Corporation on Behalf of the Biotechnology Industry Organization
    Good afternoon. My name is Thomas Okarma. I am the President and 
CEO of Geron Corporation in Menlo Park, California. Geron is a 
biopharmaceutical company focused on discovering, developing, and 
commercializing therapeutic and diagnostic products for applications in 
oncology, drug discovery and regenerative medicine. Geron's product 
development programs are based upon three patented core technologies: 
telomerase, human pluripotent stem cells, and nuclear transfer.
    I am testifying today on behalf of my company and the Biotechnology 
Industry Organization (BIO). BIO represents more than 950 biotechnology 
companies, academic institutions, state biotechnology centers and 
related organizations in all 50 U.S. states and 33 other nations. BIO 
members are involved in the research and development of health care, 
agricultural, industrial and environmental biotechnology products.
    Mr. Chairman, and members of the Subcommittee, thank you for the 
opportunity to testify today at this important hearing on cloning. Let 
me start by making our position perfectly clear: BIO opposes human 
reproductive cloning. It is simply too dangerous technically and raises 
far too many ethical and social questions.
    That's why BIO wrote to President Bush earlier this year and urged 
him to extend the voluntary moratorium on human reproductive cloning 
which was instituted in 1997. I would respectfully ask for this letter 
to be included in the hearing record.
    It would be extremely dangerous to attempt human reproductive 
cloning. It took over 270 attempts before Dolly was successfully 
cloned. In fact, in most animals, reproductive cloning has no better 
than a 3-5% success rate. That is, very few of the cloned animal 
embryos implanted in a surrogate mother animal survive. The others 
either die in utero--sometimes at very late stages of pregnancy--or die 
soon after birth. Only in cattle have we begun to achieve some 
improvements in efficiency. However, scientists have been attempting to 
clone many other species for the past 15 years with no success at all. 
Thus, we cannot extrapolate the data from the handful of species in 
which reproductive cloning is now possible to humans. This underlines 
that this would be an extremely dangerous procedure.
    It is simply unacceptable to subject humans to those risks. Rogue 
and grandstanding so-called scientists who claim they can--and will--
clone humans for reproductive purposes insult the hundreds of thousands 
of responsible, reputable scientists who are working hard to find new 
therapies and cures for millions of individuals suffering from a wide 
range of genetic diseases and conditions.
    The Food and Drug Administration (FDA) has publicly stated that it 
has jurisdiction over human reproductive cloning experiments and that 
it will not approve them. BIO supports that view and hopes that the 
next FDA commissioner--whoever that might be--will assert FDA's current 
statutory authority forcefully.
    There are also many ethical concerns raised by the specter of 
cloning. As noted in BIO's letter to the President, ``Cloning humans 
challenges some of our most fundamental concepts about ourselves as 
social and spiritual beings. These concepts include what it means to be 
a parent, a brother, a sister and a family.
    ``While in our daily lives we may know identical twins, we have 
never experienced identical twins different in age or, indeed, 
different in generation. As parents, we watch with wonder and awe as 
our children develop into unique adults. Cloning humans could create 
different expectations. Children undoubtedly would be evaluated based 
on the life, health, character and accomplishments of the donor who 
provides the genetic materials to be duplicated. Indeed, these factors 
may be the very reasons for someone wanting to clone a human being.''
    As you can see, Mr. Chairman, many of these issues strike at the 
heart of beliefs and values that are inherent in the human condition. 
What does it mean to be an individual? How should we view our parents, 
brothers, sisters, and children? How does the world around us influence 
our intellectual, physical and spiritual development? These are just a 
few of the questions raised by human cloning. In my view, reproductive 
cloning would devalue human beings by depriving them of their own 
uniqueness.
    To allow human reproductive cloning would be irresponsible. Worse 
yet, it could lead to a backlash that would stifle the numerous 
beneficial applications of therapeutic cloning technology--some of 
which I will describe today--that could lead to cures and treatments 
for some of our most deadly and disabling diseases.

                 BENEFICIAL USES OF CLONING TECHNOLOGY

    It is critical to distinguish use of cloning technology to create a 
new human being (reproductive cloning) from other appropriate and 
important uses of the technology such as cloning specific human cells, 
genes and other tissues that do not and cannot lead to a cloned human 
being (therapeutic cloning). These techniques are integral to the 
production of breakthrough medicines, diagnostics and vaccines to treat 
many diseases. They could also produce replacement skin, cartilage and 
bone tissue for burn and accident victims, and result in ways to 
regenerate retinal and spinal cord tissue.
    Let me briefly explaining a cloning technology--somatic cell 
nuclear transfer--and how it is used for research purposes. First, the 
nucleus of an egg cell is removed. In its place, we 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. At about 3-5 days, a blastocyst is formed which 
contains an inner cell mass comprised of undifferentiated, pluripotent 
cells. These cells are removed and used for research. The research 
value of these cells is enormous. These stem cells have the potential 
to form any cell in the body and can replicate indefinitely. Studies in 
animals demonstrate that this could lead to cures and treatments for 
millions of Americans who suffer from diseases and disabilities such as 
diabetes, stroke, Parkinson's Disease, heart disease, and spinal cord 
injury.
    As exciting as that is--it's only a part of the story. The full 
potential of this technology comes from its use in regenerative 
medicine.

                         REGENERATIVE MEDICINE

    Many diseases result in the disruption of cellular function or 
destruction of tissue. Heart attacks, strokes, and diabetes are 
examples of common conditions in which critical cells are lost to 
disease. Today's medicine is unable to completely restore this loss of 
function. Regenerative medicine, a new therapeutic paradigm, holds the 
potential to cause an individual's currently malfunctioning cells to 
begin to function properly again or even to replace dead or irreparably 
damaged cells with fresh healthy ones, thereby restoring organ 
function.
    The goal of Geron's regenerative medicine program is to produce 
transplantable cells that provide these therapeutic benefits without 
triggering immune rejection of the transplanted cells. This could be 
used to treat numerous chronic diseases such as diabetes, heart 
disease, stroke, Parkinson's Disease and spinal cord injury.
    At Geron, therapeutic cloning technology is one of the techniques 
we use to create pure populations of functional new cells that can 
replace damaged cells in the body. For example, we are learning how to 
turn undifferentiated human pluripotent stem cells into neurons, liver 
cells and heart muscle cells. Thus far, these human replacement cells 
appear to function normally in vitro, raising the possibility for their 
application in the treatment of devastating chronic diseases affecting 
these tissue types. This would, for instance, allow patients with heart 
disease to receive new heart muscle cells that would improve cardiac 
function. Cellular cloning techniques are a critical and necessary step 
in the production of sufficient quantities of vigorous replacement 
cells for the clinical treatment of patients.
    Somatic cell nuclear transfer research is essential if we are to 
achieve our goals in regenerative medicine. We must understand the 
biological properties of the egg cell (and the transferred nucleus) 
that cause a differentiated cell to turn into a pluripotent cell. This 
process is called ``re-programming''--and we're still not sure how it 
works. That's why we need to continue to perform research.
    At Geron, our aim is to harness and therapeutically apply the power 
of this biology. Once we fully understand re-programming we will be 
able to develop specific cells for transplantation without immune 
rejection. We'll do that by taking a differentiated cell from a 
particular individual and re-programming it to form a pluripotent cell 
from which we can produce the differentiated cells we need for 
transplantation back into that individual. By using the patient's own 
cells as starting material, we will avoid complications due to immune 
response rejection.
    However, this is precisely the research that would be banned by the 
Weldon bill. Because the Weldon bill does not distinguish between 
reproductive cloning and use of cloning for research purposes, it will 
cut off this work and prevent its therapeutic applications from 
reaching patients. In contrast, the bi-partisan bill introduced by 
Reps. Greenwood, Deutsch, and others bans reproductive cloning but 
allows the continuation of research. BIO supports Greenwood/Deutsch 
because it strikes the appropriate balance between prohibiting acts 
that are unsafe and unethical, while promoting vital medical research.
    It is important to emphasize that once we understand the molecular 
biology of re-programming, we will no longer need to use egg cells or 
create blastocysts. Therefore, this technology is likely to be used 
only for a short, finite period of time. Moreover, understanding the 
biology re-programming is a critical step to improve the usefulness of 
adult stem cells. Ironically, therefore, the Weldon bill will also be a 
setback to adult stem cell research.

                               CONCLUSION

    As the current Congress pursues legislative prohibitions on human 
reproductive cloning, we urge caution and a distinction between 
reproductive and therapeutic cloning. We all agree that given the 
current safety and social factors, human reproductive cloning is 
repugnant. However, it is critical that in our enthusiasm to prevent 
reproductive cloning, we not ban vital research, turning wholly 
legitimate biomedical researchers into outlaws, and thus squelching the 
hope of relief for millions of suffering individuals.
    Our nation is on the cusp of reaping the long dreamed of rewards 
from our significant investment in biomedical research. The U.S. 
biotech industry is the envy of much of the world, especially our 
ability to turn basic research at NIH and universities into applied 
research at biotech companies and in turn, into new therapies and cures 
for individual patients. Using somatic cell nuclear transfer and other 
cloning technologies, biotech researchers will continue to learn about 
cell differentiation, re-programming, and other areas of cell and 
molecular biology. Armed with this information, they can eventually 
crack the codes of diseases and conditions that have plagued us for 
hundreds of years, indeed, for millennia.
    In conclusion, Mr. Chairman, human reproductive cloning remains 
unsafe, and the ethical issues it raises have not been reasonably 
resolved. It should be prohibited. However, as Congress seeks to outlaw 
reproductive cloning, it must not write legislation that will stop 
research using cloning technology. Unfortunately, the Weldon bill fails 
that test. Simply put, enactment of the Weldon bill will stop critical 
therapeutic research in its tracks. Only Greenwood/Deutsch strikes the 
right balance.
    Thank you for the opportunity to testify. I'll be happy to answer 
any questions.

    Mr. Bilirakis. Thank you. Dr. Kass, please proceed, sir.

                    STATEMENT OF LEON R. KASS

    Mr. Kass. Thank you, Mr. Chairman, for the opportunity to 
testify before the subcommittee. I am Leon Kass. I am a 
professor at the University of Chicago. I have been 
professionally concerned for over 30 years with the ethical 
implications of biomedical technologies.
    These technologies have now brought us to a crucial fork in 
the road where we are compelled to decide whether we wish to 
travel down the path that leads to the brave, new world. That, 
and nothing less, is what is at stake in your current 
deliberations about whether we should tolerate the practice of 
human cloning.
    And if I may say so, I have heard Members of Congress say 
that we should be very careful not to jeopardize the health 
benefits that are available from research cloning. I think we 
should be very careful before we take any step that might lead 
us in an accelerated path down this road toward the brave, new 
world. Care has to be exercised on both sides.
    I am here to testify in favor of a national ban on human 
cloning, and in particular, in favor of H.R. 1644, the Human 
Cloning Prohibition Act 2001, for two reasons.
    First, I believe that cloning human beings is unethical, 
both in itself and, importantly, in what it will surely lead 
to. And second, I believe that this bill offers us the best, 
indeed the only, reasonable chance of preventing human 
reproductive cloning from happening.
    In the written testimony, I give the ethical arguments as 
to why we should object to human reproductive cloning. Having 
heard no dissent on that, I will simply skip over that and take 
it for granted that we agree on that, and speak only about the 
legislative approaches.
    But I do want to say one thing here. There is more at stake 
in this question than the simple question of cloning, because 
what we would be establishing if we say yes to cloning, is that 
we will be establishing, as a dangerous principle, the right 
that we have to determine in advance the genetic make-up of our 
children.
    If we won't--don't want to travel down that road, we want 
to make sure that we have an effective ban on human cloning 
now, before we are overtaken by events. It is important that we 
do something now.
    Two legislative approaches have been proposed. One would 
ban only so-called reproductive cloning by prohibiting the 
transfer of a cloned embryo to a woman to initiate a pregnancy. 
The other would ban all cloning by prohibiting the creation 
even of the embryonic clones.
    I had, once upon a time, looked for a third way, but I am 
now convinced that an effective ban on reproductive cloning 
requires a ban on all cloning, on all cloning, including the 
creation of the embryonic clones, and here is why.
    Once the cloned embryos are produced and available in the 
laboratories and assisted reproduction centers, it will be 
virtually impossible to control what is done with them.
    Stockpiles of cloned human embryos could be produced, 
bought and sold without anyone's knowing it. Efforts at clonal 
reproduction would take place out of sight, within the privacy 
of the doctor/patient relationship. And moreover, a ban on only 
reproductive cloning will turn out to be unenforceable.
    Should illicit cloning be discovered, governmental attempts 
to enforce the reproductive ban would run into a swarm of legal 
and practical challenges. And the practice at that stage, I 
submit, would be impossible to police or regulate.
    Therefore, if you are serious--anyone who is really serious 
about trying to prevent human reproductive cloning must seek to 
stop this process at the start.
    Now, I believe H.R. 1644 is precisely suited to accomplish 
this goal, no more and no less. It explicitly and precisely 
defines the specific deed that is outlawed, human somatic cell 
nuclear transfer to an egg, and it does not entangle us in 
difficult determinations of the perpetrator's intent or 
knowledge.
    It is extremely carefully drafted and limited in its scope, 
and it makes it clear that there is to be no interference with 
scientifically and medically useful practices of animal cloning 
or equally valuable cloning of human DNA fragments, duplication 
of cells, stem cells or somatic cells, in culture.
    And if enacted, this bill would bring the United States 
into line with the already and soon-to-be-enacted practices of 
many other nations. And we should take the lead, rather than be 
an outlaw nation in this regard.
    People who prefer the other approach, namely a ban only on 
the transfer of a human clone to initiate a pregnancy, will 
probably look with favor on the other bill before you, H.R. 
2172.
    But please observe; in my opinion, I think a careful 
consideration of the specifics of this bill shows that it does 
not effectively provide the ban on reproductive cloning that 
everyone wants.
    Indeed, it does not explicitly ban reproductive cloning at 
all. It prohibits only two things. First, it prohibits the 
creation of the embryonic clones by people whose intent it is 
to begin a pregnancy; and second, it prevents people from 
shipping or transporting the ``cellular product resulting from 
this transfer,'' but only if they know that the product is 
intended to be used to initiate a pregnancy. Those are the only 
two acts that are prohibited.
    Put those two prohibitions taken together; they fail to 
outlaw a pregnancy initiating transfer of a cloned embryo to a 
woman by someone other than its manufacturer. Indeed, nowhere 
in this bill, nowhere in this bill, does it specifically ban 
the act of reproductive transfer to a woman by anyone.
    And if this bill really, seriously intended to outlaw 
reproductive cloning, it should have read that, ``It shall be 
unlawful to use the cellular product of somatic cell nuclear 
transfer to initiate a pregnancy.'' It nowhere says anything 
that clear. This bill fails to outlaw the attempts to create a 
live, born human-cloned individual.
    Consider this possible scenario. It is very clear. I create 
the embryos by somatic cell nuclear transfer. You buy them from 
me, and you tell me that you want them for research. And I ship 
them to you, taking you at your word.
    Your company changes management, or you change your mind, 
and they decide it is profitable to use the purchased embryos 
for reproductive cloning. Under the terms of this bill, I have 
done nothing illegal; you have done nothing illegal, and the 
cloned child is born.
    In brief, with all due respect, as I read the present text 
of the Greenwood bill, it seems to be less the Cloning 
Prohibition Act of 2001 and more the Human Embryo Cloning 
Registry and Industry Protection Act of 2001.
    It is not the reproductive cloning ban the American people 
are looking for. And I have some other things, some----
    Mr. Bilirakis. Please summarize, Dr. Kass.
    Mr. Kass. [continuing] details. I will just wind up. It 
seems to me, as the composition of this panel of witnesses will 
make clear, the issue of human cloning is not an issue of pro-
life or pro-choice. It is not mainly about death and 
destruction. It is not about a woman's right to choose. It is 
not about stem cell research. It is not even about the basic 
freedom of scientists to inquire.
    It is most emphatically about baby design and manufacture. 
And it is the opening skirmish in a long battle against 
eugenics and the post-human future.
    Once the embryonic clones are produced in the laboratories, 
this eugenic revolution will have begun, and we will have lost 
our best chance to do something about it.
    [The prepared statement of Leon R. Kass follows:]

  Prepared Statement of Leon R. Kass, Addie Clark Harding Professor, 
 Committee on Social Thought and the College, The University of Chicago

    Thank you, Mr. Chairman, for the opportunity to testify before the 
subcommittee. I am Leon R. Kass, Addie Clark Harding Professor in the 
Committee on Social Thought and the College, The University of Chicago. 
I have been professionally concerned, for over 30 years, with the 
ethical implications of biomedical advance. Originally trained in both 
medicine and biochemistry, I remain enthusiastic about biomedical 
research and its promise to cure disease and relieve suffering. Yet, as 
has been obvious for some time, new biotechnologies are also providing 
powers to intervene in human bodies and minds in ways that go beyond 
the traditional goals of healing the sick, to threaten fundamental 
changes in human nature and the meaning of our humanity. These 
technologies have now brought us to a crucial fork in the road, where 
we are compelled to decide whether we wish to travel down the path that 
leads to the Brave New World. That, and nothing less, is what is at 
stake in your current deliberations about whether we should tolerate 
the practice of human cloning.
    I am here to testify in favor of a national ban on human cloning 
and, in particular, in favor of HR 1644, ``The Human Cloning 
Prohibition Act of 2001,'' for two reasons. First, I believe that human 
cloning is unethical, both in itself and in what it surely leads to. 
Second, I believe that this bill offers us the best--indeed, the only--
reasonable chance at preventing human reproductive cloning from 
happening. (The full version of my argument is contained in a recent 
essay, ``Preventing a Brave New World: Why We Should Ban Human Cloning 
Now,'' written precisely to gain support for such a bill and published 
in the May 21, 2001 issue of The New Republic. I submit it as an 
appendix to this statement.)
    The vast majority of Americans object to human cloning, and on 
multiple moral grounds, among them the following. It constitutes 
unethical experimentation on the child-to-be, subjecting him or her to 
enormous risks of bodily and developmental abnormalities. It threatens 
individuality, by deliberately saddling the clone with a genotype that 
has already lived and to whose previous life its life will always be 
compared. It confuses identity by denying the clone two biological 
parents and by making it the twin of its older copy. It represents a 
giant step toward turning procreation into manufacture (especially when 
understood as the harbinger of non-therapeutic genetic manipulations to 
come). And it is a radical form of parental despotism and child abuse--
even when practiced freely and on a small scale. Permitting human 
cloning means saying yes to the dangerous principle that we are 
entitled to determine and design the genetic make-up of our children. 
If we do not wish to travel down this eugenic road, an effective ban on 
cloning human beings is needed, and needed now before we are overtaken 
by events.
    A majority of members of Congress, I believe, are, like most 
Americans, opposed to human cloning. But opposition is not enough. For 
if Congress does nothing about it, we shall have human cloning, and we 
shall have it soon. Congress' failure to try to stop human cloning--and 
by the most effective means--will in fact constitute its tacit 
approval.
    What, then, is the most effective way to stop reproductive human 
cloning? Two legislative approaches competed with each other the last 
time Congress took up this issue. One bill would have banned only so-
called reproductive cloning by prohibiting the transfer of a cloned 
embryo to a woman to initiate a pregnancy. The other bill would have 
banned all cloning by prohibiting the creation even of the embryonic 
human clones. Both sides opposed reproductive cloning, but because of 
the divide over the question of embryo research we got no ban at all. 
It would be tragic if we again failed to produce an effective ban on 
cloning human beings, especially now that certain people are going 
ahead with it and defying us to try to stop them.
    A few years ago, I was looking for a middle way between the two 
alternatives that failed last time, but I am now convinced that an 
effective ban on reproductive cloning requires a ban on all human 
cloning, including the creation of the embryonic clones. Anyone truly 
serious about preventing human reproductive cloning must seek to stop 
the process from the beginning, at the stage where the human somatic 
cell nucleus is introduced into the egg. Here is why.
    Once cloned human embryos are produced and available in 
laboratories and assisted-reproductive centers, it will be virtually 
impossible to control what is done with them. Biotechnical procedures 
and experiments take place in laboratories, hidden from public view, 
and for good commercial reasons these doings are concealed from the 
competition and everyone else. Huge stockpiles of cloned human embryos 
could thus be produced and bought and sold in the private sector 
without anyone knowing it. As we have seen with in vitro embryos 
created to treat infertility, embryos produced for one reason can be 
used for another reason: today ``spare embryos'' once created to begin 
a pregnancy are now used--by someone else--in research, and tomorrow 
clones created for research will be used--by someone else--to begin a 
pregnancy. Efforts at clonal baby-making (like other forms of assisted-
reproduction) would take place out of sight, within the privacy of a 
doctor-patient relationship, making outside scrutiny extremely 
difficult. Moreover, the transfer of embryos to begin a pregnancy is a 
simple procedure (especially compared with manufacturing the embryo in 
the first place), simple enough that its final steps could be self-
administered by the woman, who would thus absolve the doctor of blame 
for having ``caused'' the illegal transfer.
    Worst of all, a ban on only reproductive cloning will turn out to 
be unenforceable. Should the illegal practice be detected, governmental 
attempts to enforce the reproductive ban would run into a swarm of 
practical and legal challenges, both to efforts aimed at preventing 
embryo transfer to the woman and--even worse--to efforts seeking to 
prevent birth after the transfer has occurred. Should an ``illicit 
clonal pregnancy'' be discovered, no government agency is going to 
compel a woman to abort the clone, and there would be an understandable 
swarm of protest should she be fined or jailed before or after she 
gives birth.
    For all these reasons, the only practically effective and legally 
sound approach is to block human cloning at the start, at the 
production of the embryonic clone. Such a ban is rightly characterized 
not as interference with reproductive freedom, nor even as 
unprecedented or dangerous interference with scientific inquiry, but as 
an attempt to prevent the unhealthy, unsavory, and unwelcome 
manufacture of and traffic in human clones. It would do what the 
American people want done: stop human cloning before it starts.
    H.R. 1644, introduced by Dr. Weldon and joined now by more than 100 
cosponsors, is just what the doctor ordered, precisely suited to 
accomplish this goal, no more and no less. It explicitly and precisely 
describes the specific deed that is outlawed (human somatic cell 
nuclear transfer to an egg), and it does not entangle us in difficult 
determinations of the perpetrator's intent or knowledge. Its 
substantial criminal and monetary penalties will almost certainly shift 
the incentives for renegades who are tempted to proceed. Extremely 
carefully drafted and limited in its scope, the bill makes very clear 
that there is to be no interference with the scientifically and 
medically useful practices of animal cloning or the equally valuable 
cloning of human DNA fragments, the duplication of somatic cells, or 
stem cells in tissue culture. Moreover, if enacted this bill would 
bring the United States into line with the already and soon-to-be-
enacted practices of other nations, and, in collaboration with these 
efforts, offers us the best and, I think, the only realistic chance we 
have of keeping human cloning from happening, or happening much.
    People who prefer the other approach to stopping human cloning, 
namely, a ban only on transfer of an embryonic clone to initiate a 
pregnancy, will oppose H.R. 1644 and will probably look with favor on 
the other bill before this Committee, H.R. 2172, introduced last week 
by Reps. Greenwood and Deutsch. But, in my opinion, a careful 
consideration of the specifics of this bill (as now written) shows that 
it does not effectively provide the ban on reproductive cloning that 
everyone wants. Indeed, it does not explicitly ban reproductive cloning 
at all. This bill permits the use of human somatic cell nuclear 
transfer technology (HSCNTT 1), the act that creates an 
embryonic human clone. It prohibits (only) two things. First, it 
prohibits this act by people whose intent is to begin a pregnancy. 
Second, it prohibits people from shipping or transporting ``the 
cellular product resulting from HSCNTT,'' but only if they know that 
``the product is intended to be used to initiate a pregnancy.'' These 
two prohibitions, even taken together, fail to outlaw a pregnancy-
initiating transfer of a cloned embryo to a woman--by someone other 
than its manufacturer. (Indeed, nowhere does the bill specifically ban 
the act of reproductive transfer to a woman by anyone.2) As 
a result, this bill fails to outlaw efforts to create a live-born human 
cloned individual.
---------------------------------------------------------------------------
    \1\ HSCNTT is defined as the act of ``transferring the nucleus of a 
human somatic cell into an egg cell from which the nucleus has been 
removed or rendered inert.''
    \2\ Readers of the bill may see this for themselves, by 
substituting the statutory definition of HSCNTT [provided in SEC. 1001. 
(a) (2)] into the first prohibition [SEC. 1001. (a) (1) (A): ``It shall 
be unlawful to transfer or to attempt to transfer the nucleus of a 
human somatic cell into an egg cell from which the nucleus has been 
removed or rendered inert with the intent to initiate a pregnancy.'' 
That this is the correct meaning of what is prohibited can be confirmed 
by the appearance, in the description of the second prohibited act 
[SEC. 1001. (a) (1) (B)], of the phrase ``cellular product resulting 
from HSCNTT,'' that is, the embryonic human clone. If the bill wanted 
explicitly to ban the act of so-called reproductive human cloning, the 
first prohibition could and should have read: ``It shall be unlawful to 
use the cellular product of HSCNTT to initiate a pregnancy.'' 
Furthermore, such a proscription would have made the prohibition of 
shipping and transporting unnecessary.
---------------------------------------------------------------------------
    The Greenwood-Deutsch bill places virtually no restrictions on the 
use of licitly produced ``cellular products'' of the technology (i.e., 
the embryonic clones), once they are created. Strikingly, there is no 
prohibition on receiving the ``cellular product'' of HSCNTT (i.e., the 
embryos) with an intent to initiate a pregnancy; indeed, there is no 
restriction whatsoever on what the purchaser of such embryos may do 
with them. Consider this possible scenario: I create embryo clones by 
HSCNTT. You buy them from me, telling me that you want them for 
research, and I ship them to you, taking you at your word. You change 
your mind (say, because your company's new management sees the prospect 
of gain from reproductive cloning), and you then use the purchased 
embryo (that you did not yourself create) to initiate a pregnancy. 
Under the terms of this bill, I have done nothing illegal and neither 
have you, and in the meantime, the cloned child is born.
    There are two further difficulties with this bill. The two banned 
acts turn entirely either on intent or on foreknowledge of someone 
else's intent--hard matters to discern and verify. Also, because the 
cloned embryo is treated like an ordinary drug whose registration with 
the FDA is (for obvious reasons) kept confidential, the public will be 
completely in the dark even about who is producing the embryo clones, 
much less where they are being bought and sold and who is doing what 
with them. With all due respect, as I read the present text of this 
bill, it seems to me to be less the ``Cloning Prohibition Act of 2001'' 
and more the ``Human Embryo Cloning Registration and Industry 
Protection Act of 2001.'' It is not the reproductive cloning ban the 
American people are looking for.
    I understand fully that some scientists and biotechnologists hope 
that the practice of embryo cloning would someday yield autologous 
tissues (and even organs) for transplantation, derivable for each 
person from his own embryonic twin clone, tissues useful for the 
treatment of serious chronic disease (so-called therapeutic cloning). 
Perhaps they are right. But we now have promising alternate routes to 
the same therapeutic possibilities--not only non-embryonic (so called 
adult) stem cells, but also non-cloned embryonic stem cell lines--that 
do not run the risk of opening the door to human clonal reproduction 
(and that, it should be added, will not require commodifying women's 
reproductive tissues in order to provide the enormous numbers of eggs 
that will be needed to create the cloned embryos). Should these other 
alternatives fail, and should animal cloning experiments demonstrate 
the unique therapeutic potential of stem cells derived from embryo 
cloning, Congress could later revisit this issue and consider lifting 
the ban on the cloning of embryos. H.R. 1644, in fact, provides for 
just such a review of the relevant scientific and therapeutic 
possibilities, as does H.R. 2172 (the Greenwood-Deutsch bill).
    As the composition of the panel of witnesses before you today makes 
clear, the issue of human cloning is most emphatically not an issue of 
pro-life versus pro-choice. It is not mainly about death and 
destruction, and it is not about a woman's right to choose. It is only 
and emphatically about baby design and manufacture, the opening 
skirmish of a long battle against eugenics and against the post-human 
future. Once embryonic clones are produced in laboratories, the eugenic 
revolution will have begun, and we will have lost our best chance to do 
anything about it.
    The present danger posed by human cloning is, paradoxically, also a 
golden opportunity. The prospect of cloning, so repulsive to 
contemplate, is the occasion for deciding whether we shall be slaves of 
unregulated innovation and, ultimately, its artifacts, or whether we 
shall remain free human beings who guide our medical powers toward the 
enhancement of human dignity. The preservation of the humanity of the 
human future is now in our hands.

    Mr. Bilirakis. Thank you very much, sir.
    Mr. Guenin--is that correct?
    Mr. Guenin. Guenin.
    Mr. Bilirakis. Mr. Guenin. Thank you, you may proceed.

                  STATEMENT OF LOUIS M. GUENIN

    Mr. Guenin. Mr. Chairman and members of the subcommittee, I 
am Louis Guenin of the Department of Microbiology and Molecular 
Genetics at Harvard Medical School where my field of work is 
ethics.
    In order to assist the subcommittee, the talk that I should 
like to set for myself is to unmask the compelling, but 
sometimes overlooked grounds for moral approval of non-
reproductive somatic cell nuclear transfer.
    I shall emphasize that we should insist for every moral 
view on an analysis faithful to that view's fundamental 
commitments; and that from such an analysis, we find that moral 
views that are sometimes invoked against this research, in 
fact, pronounce it not only permissible, but virtuous.
    So, I shall be speaking about the instrumental use of 
embryos; that is the use of embryos as means, not ends in 
themselves. We may distinguish two sets of embryos for this 
purpose. The first consists of embryos that are produced by in 
vitro fertilization for the purpose of pregnancy. And the 
second consists of those produced by in vitro fertilization or 
somatic cell nuclear transfer solely for the purpose of medical 
treatment or research.
    We may say that the elements of that first set are created 
by reproductive embryo creation, and that making elements of 
the second set is an instance of non-reproductive embryo 
creation.
    I use that expression instead of the word ``cloning,'' 
because in this instance, although the genome of the supposed 
donor is, in fact, copied, the nuclear donor is not, himself or 
herself, copied. There is never an offspring.
    So, the question is whether it is moral to use an embryo as 
means. Some readers of the philosopher Kant would believe that 
that question answers itself because Kant teaches us to ``use 
humanity . . . always at the same time as an end, never simply 
as a means.''
    But for Kant, ``humanity'' includes only rational beings. 
And the subject of current scientific interest consists of 
microscopic embryos that do not have brains and are not 
rational.
    What we may do with them, according to Kantian morality, 
would follow from the command that we--that we, as universal 
beings, act on universal laws, that we can will without 
contradicting ourselves.
    One such law, holds Kant, states a duty to aid others. 
There is no contradiction in willing that scientists should 
relieve suffering, and that the rest of us should join in 
supporting him by using donated, unenabled embryos.
    The developmental potential of an embryo becomes 
``enabled,'' as I use that expression, if and only if the 
embryo enters a woman's reproductive system. The boundary of 
the human body separates enabled from unenabled embryos.
    I would like to identify a set of unenabled embryos that is 
permissible to use as means. Suppose that Mary wants to help 
others by donating--donating to research or therapy an embryo 
created in an earlier attempt at pregnancy, or an egg designed 
to be used in somatic cell nuclear transfer.
    She, thereupon, issues instructions that prohibit the--
prohibit reproduction; that is, she prohibits the embryo be 
implanted in a uterus. And she also prohibits nurture of the 
embryo for more than 14 days. That period of time is important 
because until the 14th day, an embryo can split, forming twins, 
and any twins can recombine.
    So, in view of that, there is not the individuation of a 
person. In the words of the late Harvard philosopher W.V. 
Quine, ``No entity without identity.''
    Consider also the case of Michael, who suffers from 
Parkinson's disease. He contributes a somatic cell for the 
purpose of enabling a autologous transplant; that is, a 
transplant to him of cells bearing his own genome. And he 
imposes the same restrictions as does Mary.
    For an unenabled and unindividuated embryo donated by 
someone like Mary or Michael, whether from a fertility clinic 
or created solely for research or therapy, I use the term 
``epidosembryo''. This comes from the Green ``epidosis'' for a 
beneficence to the common weal.
    The donation of such an embryo is a generous act, but we 
have to ask still whether it is permissible for scientists to 
use it. Enablement of an embryo, as I have described it, is an 
entirely discretionary act.
    No woman is obliged to undergo intrauterine transfer of an 
embryo. The instructions that are issued by donors of 
epidosembryos conclusively foreclose any chance that the 
embryos will become babies. They will never be enabled.
    The instructions allow research or therapy and nothing 
else. And that is a decision that the donors make, not the 
recipients. Therefore, there is no possible person that 
corresponds to such an embryo.
    Moreover, an early stage embryo, so small that it is 
invisible to the naked eye, lacks the sensory apparatus to feel 
pleasure or pain.
    Because the use of such an embryo cannot thwart the 
actualization of any possible person, because an embryo cannot 
suffer any discomfort, it is permissible to use the embryo in 
aid of others.
    Some witnesses will be objecting that it is wrong to create 
an embryo for some purpose other than procreation. According to 
a previously influential teleological view that trances to 
Aristotle, in every creature, every cell has a purpose. And we, 
today, even think that, in many cases, we know what the purpose 
is.
    It is a short step, then, to say that this notion of a 
mapping of cells to purposes is not purely of human origin, but 
perhaps of divine. And thereupon, some would object to 
highjacking cells to be used for some purpose other than their 
ordained purpose.
    But we mortals formerly thought that bone marrow was used 
only to nurture bone. And now, we know that it is the factory 
for the manufacture of blood.
    We used to think that kidneys exist only for benefit of 
those that enclose them. And now, we think it virtuous to 
donate one's kidney.
    We know that oocytes, when they are fertilized, develop 
into children, or at least some of them do. But who of us can 
say that sexual reproduction is the sole end that an oocyte may 
permissibly serve.
    Even assuming that the biological function of an oocyte 
were singular and known, it does not follow that it is immoral 
to deploy it for some other purpose. Nor is it obvious that a 
moral wrong occurs if an embryo dies without implanting in the 
uterus.
    Embryos die in that manner, in vivo, all the time. And we 
do not treat their passing as the death of a person.
    Now, to take an explicitly religious point of view, suppose 
that we could have a conversation with God about this. We tell 
him that we have discovered stem cells and, furthermore, we 
have discovered somatic cell nuclear therapy.
    I suspect his first reaction might be gently to tease us 
that it took a few thousand years to get here. But to be 
serious about it, I think he would commend us for an attempt to 
help others.
    In view of what is known as the second greatest of the 
Commandments, I suspect he would praise epidosembryo donors. I 
doubt that he would stand on metaphysics about early stage 
microscopic embryos, but rather wish us----
    Mr. Bilirakis. If you could summarize, Mr. Guenin?
    Mr. Guenin. Yes, Mr. Chairman--rather wish us to use our 
abilities to relieve suffering. The burden of my testimony, I 
would therefore conclude, is that it would disserve the cause 
of morality, disserve our fulfillment of our duty to aid those 
who suffer if any government action were to thwart non-
reproductive somatic cell nuclear transfer.
    When I speak of morality, I refer to the intersection of 
the leading moral views of our time on this kernel, that it is 
virtuous to relieve suffering in actual lives when we may do so 
at no cost in potential lives.
    In my written statement, I would just mention that I make 
the following further points: that Catholicism should be 
counted as an ally of this research, not an opponent. This 
relates to its fundamental belief in the duty to relieve 
suffering.
    And the fact that the thesis of zygotic personhood draws 
Catholicism into contradiction not only of its 18th Century-
long belief otherwise, but of its fundamental belief in soul, I 
suggest that it is misleading to conflate the abortion of an 
enabled conceptus with experiment on an unenabled conceptus.
    And I make some points of Constitutional and drafting about 
the pending legislation. I suggest----
    Mr. Bilirakis. In your written statement?
    Mr. Guenin. Pardon me?
    Mr. Bilirakis. In your written statement, you make----
    Mr. Guenin. Yes.
    Mr. Bilirakis. [continuing] those points?
    Mr. Guenin. Yes. If I may just close with this, final----
    Mr. Bilirakis. Please close.
    Mr. Guenin. [continuing] sentence, Mr. Chairman? I suggest 
there that a sensible prescription would prohibit ``transfer to 
a uterus of an embryo created by somatic cell nuclear 
transfer.'' That would paint, without using too broad a brush. 
Thank you, Mr. Chairman.
    [The prepared statement of Louis M. Guenin follows:]
 Prepared Statement of Louis M. Guenin, Department of Microbiology and 
               Molecular Genetics, Harvard Medical School
    Mr. Chairman and Members of the Subcommittee, the task that I 
should like to set for myself, in order to assist the Subcommittee in 
its consideration of legislation against human cloning, is to unmask 
the compelling grounds for moral approval of nonreproductive somatic 
cell nuclear transfer (``SCNT''). The method leading to the conclusions 
that I shall offer is simple to describe though somewhat difficult to 
execute. It consists first in probing moral views until we have passed 
beyond phrases and aspirations to the most fundamental commitments of 
each. It then requires us to construct a moral analysis faithful to 
each view. I shall emphasize that if we insist on this regimen, we 
shall find that even moral views thus far invoked against 
nonreproductive SCNT commend it as not only permissible but virtuous.

                           1. EMBRYO SUBJECTS

    I shall be speaking about the instrumental treatment of embryos, 
the use of embryos as means rather than as ends in themselves. An 
embryo treated instrumentally is an ``embryo subject.'' We may 
distinguish two sets of embryo subjects:
    (a) a set A each element of which is an embryo created by in vitro 
fertilization (``IVF'') for the purpose of pregnancy, and
    (b) a set B each element of which is an embryo created by IVF or 
SCNT solely for the purpose of medical treatment or research.
    We may say that elements of A are created by ``reproductive embryo 
creation,'' and those of B by ``nonreproductive embryo creation,'' the 
latter standing for any process of embryo creation for a purpose other 
than producing a baby. I do not use the term ``cloning'' for 
nonreproductive embryo creation by SCNT (``nonreproductive SCNT'') 
because in that process, no copy of the nucleus donor ever develops. No 
infant is born. Only the donor's nuclear genome is copied. 
Nonreproductive embryo creation does not risk deformed or socially 
anomalous offspring or like problems that may trouble us about 
reproductive use of SCNT in humans (``reproductive cloning'').

      2. KANT'S MORALITY AS PROPONENT, NOT OPPONENT, OF EMBRYO USE

    In considering elements of A or B as research subjects, we 
encounter a different problem. Is it moral to use an embryo as a means? 
Some readers of Kant have thought that this question answers itself. 
The second form of Kant's categorical imperative, embraced by many 
religious traditions, bids us to ``use humanity . . . always at the 
same time as an end, never simply as a means.'' But as I have explained 
elsewhere (``Morals and Primordials,'' Science 292: 1659-1660 [2001], 
copy attached), by ``humanity'' Kant understands only rational beings. 
The early stage embryo subjects of current scientific interest are 
microscopic. They do not have brains, they are not rational. For 
Kantian guidance on how we must act with respect to any nonrational 
being, we must look to a more general principle. That is the command 
that we as rational beings act only on those maxims that, without 
contradicting ourselves, we can will as universal laws. One such law, 
Kant holds, states a duty of mutual aid. When we imagine that we stand 
seriatim in the shoes of our fellows who suffer from diseases that we 
might cure, we do not contradict ourselves in willing that we 
collectively support biomedical scientists in the relief of suffering 
by use of donated unenabled embryos.

  3. THE EPIDOSEMBRYO SUBJECT, AN UNENABLED UNINDIVIDUATED EMBRYO TO 
                  WHICH NO POSSIBLE PERSON CORRESPONDS

    Let me explain enablement, the key concept that I have introduced 
here. I say that the developmental potential of an embryo becomes 
enabled if and only if the embryo enters a woman's reproductive system 
(either fallopian tubes or uterus). The boundary of the human body 
separates enabled embryos from unenabled embryos. I shall describe, if 
I may, a set of unenabled embryos that one may permissibly use as 
means. Suppose that Mary wants to help others by donating to research 
or therapy (a) an embryo produced from one of her eggs in an earlier 
fertility procedure or (b) an unfertilized egg for use in SCNT. In her 
donative instructions, given to the physician who recovered the egg 
from her, she prohibits reproduction. She forbids intrauterine embryo 
transfer and she also prohibits ex utero embryo nurture for more than 
fourteen days. The fourteen day constraint assures that neither 
research nor therapy will use a person as means. How is that so? Until 
day 14, any embryo can split, forming twins, and until day 14, twins 
can recombine, neither mother nor physician being the wiser. Thus until 
the end of the first fortnight, identity of an individual is not 
established, and hence it does not make sense to say that there exists 
a new person. ``No entity,'' said the late philosopher W.V. Quine, 
``without identity.''
    Consider also the case of Michael, a victim of Parkinson's disease. 
Michael arranges with his physician for a somatic cell to be removed 
from Michael's body so that via SCNT, that cell's nucleus may be used 
to generate embryonic stem cells of Michael's own genome, thereby 
enabling an autologous transplant. Michael imposes the same embryo 
restrictions as does Mary.
    For an unenabled unindividuated embryo donated by someone like Mary 
or Michael, I use the term epidosembryo. I derive this word from the 
Greek epidosis for a beneficence to the common weal. In the relief of 
suffering, epidosembryos enable the bounteous possibilities of stem 
cell research and cellular reprogramming. (Here I describe the general 
concept of an epidosembryo, whether of set A or B. The discussion in 
``Morals and Primordials'' principally concerns epidosembryos from A.) 
For the following reasons, it is morally permissible to use an 
epidosembryo. Enablement is an entirely discretionary act. No woman is 
obligated to undergo intrauterine transfer of an embryo. Instructions 
issued by epidosembryo donors conclusively foreclose any chance of 
enabling the embryos. The instructions specify research or therapy, and 
nothing else. Hence there exists no chance that an epidosembryo will 
become an infant. Therefore no possible person corresponds to such an 
embryo. To this we add that any early stage embryo--each so small as to 
be invisible to the naked eye--lacks the sensory apparatus to feel 
pleasure or pain. Because use of an epidosembryo cannot thwart the 
actualization of any possible person--no possible person corresponds to 
the embryo--and because the embryo cannot experience frustration or 
discomfort, it is permissible to use an epidosembryo in aid of others.
    Because we owe profound respect to any human life form, especially 
embryos, we cannot use embryos for frivolous means. But the hopes of 
scientists for embryo research are far from frivolous. First, from work 
on stem cells science may be able to overcome juvenile-onset diabetes, 
Parkinson's, Alzheimer's, muscular dystrophy, and other diseases, and 
to accelerate drug development by supplying for testing normal human 
cells in lieu of abnormal and animal tissues. Second, in SCNT we 
anticipate a stem cell possibility that embryos donated from fertility 
clinics cannot provide. In SCNT we have an ingenious means for 
obtaining transplantable cells of the patient's own nuclear genome. 
Such an autologous, histocompatible transplant is the holy grail of 
cell replacement therapy. For efficiency's sake, instead of creating 
cells of each patient's genome whenever needed, SCNT might be used in 
the project of creating a bank of embryonic stem cell lines. Scientists 
would culture one line for each of the more common alleles of the major 
histocompatibility complex (the set of genes that code for antigens, 
the structures that signal whether a cell is self or nonself). Or into 
cells from an embryonic stem cell line, scientists might by 
transgenesis insert a given patient's own version of the complex. Each 
of these strategies in principle could issue in transplantable cells 
that surmount the vexing problem that a patient's immune system rejects 
anything that it does not recognize as self. Third, SCNT also 
constitutes our hope for knowledge of how a cell's reprogramming can 
occur. If we can find out how reprogramming occurs in an egg following 
SCNT--we know that it does occur, but do not know the details--
clinicians might learn how to induce reprogramming of adult patients' 
cells. In such case we have the exciting prospect of inducing 
specialized cells in the adult to differentiate into developmentally 
much earlier cells that patients desperately need. Even neurons might 
be regenerated.

         4. REPLY TO OBJECTIONS CONCERNING USE OF EPIDOSEMBRYOS

    Let me address two likely objections to what I have said about 
unenabled embryos.
    (a) It might be argued that an embryo outside the body possesses a 
potential to become an infant and that we just happen to observe it at 
a preimplantation stage, a stage through which passes every embryo that 
becomes a neonate. But embryos passing through that stage inside a 
woman's body have a nontrivial chance of implanting in the uterus. 
Epidosembryos have no such chance. That is to say that they have less 
chance of becoming babies than do the gametes of a man and woman who 
have never met. Most of us would approve experiments on gametes--even 
though each contains half the genome of a possible person. For moral 
purposes, some cells and cell masses are possible persons, others are 
not.
    (b) Still it will be objected that the reason that embryos created 
by SCNT have a zero chance of becoming babies is that someone created 
them with precisely that fate in mind, and that it is wrong to create 
an embryo with no thought of procreation. (This is the moral objection 
peculiar to nonreproductive embryo creation in contrast with use of 
epidosembryos from fertility clinics.) Here I think that one can put 
one's finger on the view that may explain much of the reluctance 
understandably voiced concerning the challenged use of embryos. 
According to a previously influential teleology originating with 
Aristotle, some purpose obtains for every cell type, every structure. 
At various times in history, it has been thought that for many a cell 
and structure in the human, we humans know what the purpose is. It is a 
short step from there to the notion that the mapping of cells to 
purposes is not an accident but a divine design. Whereupon some would 
object to hijacking cells for purposes other than those ordained.
    Who can know the mind of God on this? We mortals formerly thought 
that the sole purpose of bone marrow is to nurture bone. Now we look 
upon the marrow as the factory where blood cells are manufactured. We 
used to think that kidneys exist solely for benefit of those enclosing 
them, and now we recognize the virtuousness of donating one's kidney to 
another. We know that oocytes when fertilized develop into children, 
but who is to say that sexual reproduction is the sole end that oocytes 
may permissibly serve? Even assuming that the natural function of a 
cell were both singular and known, it does not follow that it would be 
immoral to deploy it for another purpose. Nor it is obvious that a 
moral wrong occurs if embryos die without implanting in a uterus. The 
majority of embryos do die in such manner. We do not treat their 
passing as the deaths of persons.
    Let me take up a religious point of view. If we could have a 
conversation with God, is it plausible that He would tell us never to 
fertilize an egg except for purposes of creating a baby? If we informed 
Him that we had discovered stem cells, and had invented SCNT, He might 
first gently tease us that it took us a few thousand years to discover 
these things. As for what we should make of them, we may recall what 
Christianity teaches as the second greatest of the commandments, and 
the Golden Rule as embraced by virtually all religions. I suspect that 
God would commend epidosembryo donors. I suspect that He would not 
stand on metaphysics about microscopic embryos, but would wish us to 
use our humble abilities to relieve suffering--an effort that expresses 
esteem for life--when we have happened upon a way to do so in which we 
do not prevent the existence of any possible person who would otherwise 
become actual. He would know that children will not result from the use 
of epidosembryos as sources of stem cells or subjects of study.
    From a religious perspective, SCNT may even be said to offer one 
advantage over the use of embryos created with pregnancy in view. 
Nonreproductive embryo creation does not bring to an end any divine-
human procreative collaboration.

    5. BREADTH OF MORAL SUPPORT FOR NONREPRODUCTIVE EMBRYO CREATION

    The use of unenabled embryos as means for helping others, even as 
we are reminded of how carefully we must proceed, enjoys the support of 
a wide range of religious traditions. That support is even broader than 
commonly supposed. To see this, let us consider what is ostensibly the 
principal opposition. I refer to the view of the Congregation for the 
Doctrine of the Faith of the Roman Catholic Church, as joined by 
fundamentalist Christians, which asserts two doctrines: (a) that human 
life is a sacred gift of God that we must respect, and (b) zygotic 
personhood, the thesis that fertilization suffices to create a new 
person.

[a] We Respect Life by Relieving Suffering at No Cost in Potential 
        Lives
    The Congregation has declared that IVF, cloning, and other 
technological innovations in reproduction are inconsistent with the 
sanctity of human life. The reason that the Congregation rejects these 
procedures is twofold: it categorizes the procedures as nonconjugal 
reproduction, and thus as a departure from God's manner of giving life, 
and it expresses fear that they might lead to eugenics. But note that 
these two objections do not apply to procedures, such as 
nonreproductive embryo creation, that do not produce babies. What 
respect for life requires therefore remains an open question. I 
suggest, with ample support in religious traditions, including 
Catholicism, that relieving widespread human suffering when one may do 
so at no cost in potential lives--this in fulfillment of the wishes of 
generous cell donors--virtuously affirms respect for human life.

[b] Zygotic Personhood Untenable
    I have explained in my recent paper in Science that (i) zygotic 
personhood contradicts the Catholic church's more plausible teaching, 
maintained during the church's first nineteen centuries, that at 
fertilization a conceptus cannot, for lack of structures corresponding 
to the intellectual faculty that makes us human, constitute a person, 
and that (ii) zygotic personhood is refuted by the fact that embryos do 
not individuate until day 14, as Catholic theologians have recognized. 
The church, having recently conceded that personhood is a philosophical 
question, offers only one argument for zygotic personhood. That 
argument consists in identifying a new person with the genome formed at 
each conception. But the church cannot maintain this embrace of genetic 
reductionism. To do so contradicts the church's fundamental belief in 
mind and soul.
    We must first plumb the depths of any moral view before we can 
ascertain its verdict on a question at hand. When we include in our 
analysis of Catholicism its bedrock--including the second greatest of 
the commandments and the consequence that we are obliged to come to the 
aid of our neighbors and to answer the call to charity--we find a 
compelling case for epidosembryo research and therapy.
    It would be misleading to conflate the use of unenabled embryos 
with abortion. An abortion kills a conceptus developing in the womb, an 
enabled conceptus. An enabled conceptus will follow a course of 
gestation requiring only that the mother stay healthy. Whereas absent a 
voluntary act to which no one is obliged, an unenabled embryo will 
never implant, will never mature even to the fetal stage. Fewer 
abortions mean more babies. Were society to refrain from 
nonreproductive embryo creation, not one more baby would likely be 
born.

    6. WISHFUL THINKING ABOUT ADULT CELLS WILL NOT OBVIATE STUDY OF 
                               EMBRYONIC

    Opponents of embryo use have recently urged that we forego use of 
embryos and instead use cells that they characterize as functionally 
equivalent and less morally problematic, namely, adult cells. This line 
of wishful thinking, embraced in H. R. 1644, Sec. 2, finding (7), 
begins with the notion that we might confine stem cell research to 
adult stem cells. Clinging to this idea, some nonscientist opponents of 
embryo research are wont to trumpet every report about the plasticity 
of adult stem cells. Meanwhile these advocates will exaggerate every 
qualification or condition that they hear mentioned by cautious 
scientists careful not to overstate present knowledge about embryonic 
stem cells. The refutation of this wishful thinking is immediate. 
Embryonic stem cells are pluripotent, which is to say that they are 
capable of issuing in every cell type save for the placenta. Adult stem 
cells are only multipotent, each capable of issuing in no more than a 
few cell types. When pluripotency is the goal, the earlier the better. 
For some cell types, among them cardiac and pancreatic islet, no adult 
stem cells have been found. Where adult stem cells are known to exist, 
often they can be found only in small quantities and obtained only by 
intrusive means. For instance, to obtain adult stem cells useful in the 
brain, as one would wish to do for Parkinson's disease, one must drill 
a hole in the cranium. Adult stem cells may also embody the effects of 
aging and contain genetic abnormalities accumulated over the course of 
a life. If, painlessly for both donor and recipient, one could 
rejuvenate one's skin with a transplant from a family member, who would 
prefer their grandmother's skin to that of a newborn niece? We must 
also recognize that stems cell vary in the extent to which clinicians 
will be able to direct differentiation. Embryonic stem cells may prove 
easier to direct. For all these reasons, it is simply implausible that 
adult stem cells are functional substitutes for embryonic stem cells. 
Nor can one assume that embryonic germ cells, derived from abortuses 
five or more weeks old, are functionally equivalent to embryonic stem 
cells.
    It does not advance understanding to interject, as have opponents 
of embryo research, that no therapies by means of embryonic stem cells 
have yet been confirmed. For both adult and embryonic stem cells, the 
present agenda is basic research. In the U. S. there has been scant 
little research on embryonic stem cells and SCNT. Both lines of inquiry 
are stymied by law. No funds dispensed by the National Institutes of 
Health may be used for research in which embryos are destroyed (Pub. L. 
106-554, Title V, Sec. 510). It is unrealistic to expect confirmed 
therapies from research not yet performed.
    Frequently in the history of science when the prospect has appeared 
of beneficial results from several alternative avenues of inquiry, and 
when it has not been known which avenue would be the most productive, 
the practice has been to follow all paths simultaneously. Sundry 
mathematicians traveled down numerous paths, developing whole new 
fields of mathematics in the process, before Andrew Wiles combined 
insights from multiple fields into the proof of Fermat's Last Theorem. 
And then there is serendipity. Often great advances occur in one 
direction while scientists believe that they are working in another. 
Roentgen discovered x-rays without looking for them. Sometimes multiple 
avenues all bear fruit. Biomedical research could reveal a clinical 
need for all varieties of stem cells, one type for one disease, another 
type for another disease. When delay and inefficiency are measured in 
lives lost, it would be a shame to bet everything on one horse.
    The overwhelming majority of biomedical scientists prize embryonic 
stem cell research as one of the most promising frontiers for the 
relief of human suffering in our lifetime. The ability to generate 
specialized cells of all types renders the use of embryonic stem cells, 
through SCNT and otherwise, that rare strategy that can yield therapies 
in virtually all fields of medicine. If biomedical scientists imagined 
that adult cells would suffice instead, they would be the first to tell 
us so. Research on adult cells does offer some promise, should be 
pursued, and is being pursued. But the overwhelming majority of 
biomedical scientists urge that embryonic research possesses singular 
advantages and is yet more promising. On the question of which avenues 
of investigation are relatively more promising, the judgment of these 
scientists should serve as our guide, just as it does in budgetary 
decisions. We have learned from encounters with such ventures as 
``creation science,'' which purportedly refutes the theory of 
evolution, that we must be sceptical when nonscientist advocates offer 
purported analyses of scientific data to reinforce conclusions that 
they have already reached on nonscientific grounds. The current 
incarnation of data advocacy would have us believe that we have little 
to gain scientifically from the alternative that the advocates disfavor 
on moral grounds. To object to embryo research explicitly on moral 
grounds is of course quintessentially pertinent here. (Though, 
according to my analysis, morality bids us support, not oppose, that 
research.) But whatever our moral theory, if we think that the moral 
permissibility of an action depends on that action's probable success 
in achieving a scientific result, we ought to take counsel about that 
probability from science's mainstream. The voice of science's 
mainstream is resounding. We could fail to apprehend the scientific 
consensus on the singular promise of embryonic stem cell research only 
by putting our heads in the sand.
    The rationale for SCNT is even more compelling than that for 
embryonic stem cells in general, this by virtue of two advantages to 
which I have alluded--and perhaps others not yet glimpsed. First, SCNT 
affords a means of producing stem cells that are (a) ample in quantity 
and pluripotent and (b) of the patient's own genome. Adult cells do not 
allow us to achieve (a); an unrelated embryo from a fertility clinic 
will not achieve (b). Second, eggs developing after SCNT furnish the 
optimal opportunity for observing the full scale reprogramming of gene 
expression and the cell's other regulatory mechanisms, the likes of 
which either does not naturally occur in specialized cells of the 
adult, or occurs on a scale too small to allow us to learn much if we 
could observe it. By studying reprogramming in embryos, scientists hope 
to learn what steps to take in order to induce reprogramming in 
specialized cells of adult patients, which in turn could obviate the 
need to obtain embryonic stem cells for therapy. Scientists would not 
urge this research, would not predict the loss of useful therapies if 
we forgo it, if they could gain that knowledge without using embryos 
created by SCNT.
    In short, if Congress defies the advice of science's mainstream and 
excludes unenabled unindividuated embryos from research, it will 
handcuff research for no moral gain.

           7. PRESERVING THE LEGALITY OF NONREPRODUCTIVE SCNT

    As the Members well know, there obtains a scientific and, if I may 
say, a public consensus that because reproductive cloning in animals so 
often issues in deformed offspring, and because cloning in homo sapiens 
poses further technical challenges and questions that have not been 
met, we ought not presently to attempt the cloning of a human. That is 
not the whole of the moral discussion, since we can imagine a day when 
present problems have been overcome to the extent that the procedure 
has become relatively reliable. Thereupon we would return to the 
morality of ``replacing'' a lost child with a clone and of using SCNT 
to conceive a child who could be available as a histocompatible donor 
to a sick child. Consider again a religious perspective. We, none of 
us, can confidently say that, if we could have a conversation with God, 
He would tell us to shun reproductive cloning in all instances. But 
insofar as reproductive cloning is not presently reliable, and I 
therefore cannot defend it on moral grounds, I confine myself here to 
the case for preserving nonreproductive embryo creation. We may further 
narrow the discussion to nonreproductive SCNT rather than 
nonreproductive embryo creation in general. For the proposed 
legislation would forbid SCNT but not restrain the use of IVF in 
research.
    Thus far I have discussed morality, the only cited rationale for 
making nonreproductive SCNT a crime. I have argued that a close 
analysis of leading moral views reveals moral approval and praise for 
nonreproductive SCNT. This issues even from quarters that might be 
thought settled otherwise. I now turn to two pragmatic arguments. These 
have been advanced for the proposition that, even if nonreproductive 
SCNT is moral for the reasons that I have offered, the procedure should 
be prohibited anyway. The first of these arguments emanates from 
concern for enforceability of a ban on cloning, the second from fear of 
a slippery slope. I shall show that neither argument sustains the 
prohibition of nonreproductive SCNT.

[a] Difficulty of Enforcement: Inherent for Any Proscription of 
        Reproductive Conduct, Not Grounds for an Overly Broad 
        Proscription
    The first argument is broached in H. R. 1644, Sec. 2, finding (8), 
which asserts that ``it will be nearly impossible to prevent attempts 
at `reproductive cloning' once cloned human embryos are available in 
the laboratory.'' Fully stated, the argument starts with the premise 
that for satisfactory enforcement of a statute that prohibits x, law 
enforcement officials must be able to detect most instances of x. Next 
it is asserted that officials will not reliably be able to detect 
reproductive cloning if and when it is perpetrated by someone legally 
permitted to perform SCNT for research and therapy. It is then 
concluded that, by dint of such undetected violations, a statute 
prohibiting only reproductive cloning cannot be enforced to a 
satisfactory extent.
    I contend that the enforcement problem envisioned here is a red 
herring. As the foregoing argument itself implies, the question that we 
must ask, when urged to forbid all SCNT so as to tighten the noose 
around reproductive cloning, is as follows. If SCNT in research and 
therapy were permitted, what would be the probable incidence of 
surreptitious reproductive cloning by persons performing SCNT in 
research and therapy? The probable incidence, so I shall suggest, is 
negligible. The foregoing argument leaps from the observation that 
undetected violations can occur to the conclusion that significantly 
many undetected violations will occur.
    We must understand the laboratory environment. Cell biology 
laboratories--where studies of stem cells and cellular reprogramming 
would occur--do not serve patients. Such laboratories contain no 
examining rooms, no surgical suites, no equipment for the invasive 
procedures of removing an egg from an ovary or transferring an embryo 
to a uterus. Most of the scientists who work in such laboratories are 
Ph.D.s, not physicians. Eggs and somatic cells used by such 
laboratories in research will have been shipped there as donations. If 
cell donors impose the condition by which I earlier defined an 
epidosembryo, the laboratories will have use of the cells on condition 
that any resultant embryo not be transferred to a uterus. A federal law 
forbidding reproductive cloning would effectively impose this condition 
in all cases. So if a rogue scientist seeks to clone a human, that 
scientist must be surreptitious indeed. The rogue must remove an embryo 
from a laboratory's inventory and arrange an intrauterine embryo 
transfer in such fashion that the rogue and the woman receiving the 
embryo manage to keep the whole thing secret. Where can the rogue 
arrange an intrauterine transfer? He cannot engage a reputable 
physician, hospital, or clinical laboratory. If reproductive cloning is 
a federal crime, reputable providers will not perform the procedure--
just as, comporting with a nonpenal statute (Pub. L. 106-554), NIH-
supported scientists now abstain from SCNT for any purpose. Hence the 
rogue must collaborate with a woman willing to undergo an assisted 
reproduction procedure without the usual circumstances of medical care. 
And she must be willing to risk punishment by a minimum fine of 
$1,000,000 and up to ten years'' imprisonment. By proposed 18 U.S.C. 
Sec. 302(a)(2) of H. R. 1644, she and the rogue would both be guilty of 
the crime.
    A step earlier in the analysis, consider also what it would take 
for a woman to want an embryo produced in a research laboratory. As a 
solution to infertility, SCNT is inferior to IVF: IVF produces 
offspring that combine the genomes of the parents, and does not, like 
cloning, make a deformed neonate more probable than not. Therefore a 
woman interested in a baby by SCNT--if we can imagine that desire amid 
public awareness of how likely is a deformed child--will most likely 
not be infertile but instead someone seeking a clone of a previously or 
presently living human identified by her. That is the imagined primary 
motivation for cloning. Only by a highly improbable accident would an 
embryo created in a research or clinical laboratory serve a cloning 
purpose of someone other than the person who chose the somatic cell 
donor. A woman considering cloning will not want any of a laboratory's 
already extant embryos. She will want only an embryo created to order, 
an embryo bearing a genome chosen by her. We observe what follows from 
this. For the vast majority of embryos produced by SCNT in research and 
for therapy--in a reputable laboratory, for all of the embryos--there 
will be no women wishing to bear them. And in the ordinary course, the 
embryos will be consumed in research and therapy.
    So regardless how many embryos are produced by SCNT in laboratories 
across the country, for a rogue to produce an embryo acceptable to a 
given woman, the rogue must arrange yet another surreptitious 
procedure, namely, removal of a somatic cell from a corpse or living 
human chosen by her. She would also likely prefer that any embryo 
transferred to her be made of one of her eggs so that the clone will 
bear her mitochondrial DNA, not a stranger's. In order to furnish one 
of her eggs to the rogue scientist, she would have to undergo an oocyte 
recovery procedure that punctures her ovarian wall. For this she would 
need to seek out a fertility clinician, and, after the procedure, ask 
the physician to give her an egg to take home. That would immediately 
seem suspicious to the clinician because in the usual practice of IVF, 
all recovered eggs are fertilized in hopes of obtaining a few 
transferable embryos.
    From these circumstances we can see why the risk of surreptitious 
cloning via research and medical care is negligible. Talk of large 
numbers of embryos sitting around ready to make clones makes for good 
rhetoric, but we must insist on analysis. Consider further that penal 
legislation against reproductive cloning will thwart any large scale 
efforts to attempt the procedure, and in consequence its success rate 
on transferred embryos--i.e., the ratio of healthy infants to embryos 
transferred--will doubtless remain dismal. As proponents of a ban on 
reproductive cloning have observed, the public keenly understands the 
high risk of deformities through reproductive cloning and strongly 
opposes the practice. Opposition may harden if we learn that, in 
addition to the high incidence of deformities at birth, ostensibly 
healthy infant clones are found to develop serious health problems 
later in life. We do not yet know how even Dolly's life will go. All of 
which suggests that scant few women would be willing to tackle both the 
high risk of a deformed offspring and a jail sentence, fewer still if 
only a rogue will assist. Despite recent announcements by a handful of 
providers who say that they intend to produce clones, conspicuous by 
its absence is any sign that a significant number of women are willing 
to enlist. Even if, by virtue of research in other countries, the day 
arrives at which cloning has so greatly improved that the risk of 
deformities is deemed tolerable, a woman would do better to procure the 
procedure legally in a foreign country--assisted reproduction already 
serves the affluent--than to commit a crime without benefit of 
customary medical care.
    In view of all these circumstances, the notion that SCNT in 
research and therapy will to any significant extent form a conduit to 
illegal reproductive cloning seems manifestly improbable.
    Of course I do not purport to say that never will it happen that a 
researcher or provider attempts illegal reproductive cloning. Some 
illegal reproductive cloning may occur, without detection, even if 
federal law forbids all SCNT. Not only might a rare disreputable health 
care provider stray, but in theory women and cooperating cell donors 
who do not care whose eggs were used could, acting without medical 
assistance, buy oocytes through advertisements in campus newspapers, 
learn somatic cell nuclear transfer from the literature, and perform 
intrauterine embryo transfers entirely in private. A person who is 
clever and determined enough can violate any law. That does not alter 
my fundamental point. By virtue of the circumstances that I have 
described, research and clinical laboratories are not a probable back 
door route to illegal cloning.
    Upon recognizing that airtight enforcement of any law seems 
unattainable, we ought not lash out and broaden a cloning prohibition 
to sweep nonreproductive SCNT within its maw. Instead we should 
understand that enforceability depends on the chosen territory. The 
territory chosen here should give us pause. Within the penumbra of the 
Bill of Rights, as interpreted in the Supreme Court's decision in 
Griswold v. Connecticut (1965), the right of privacy extends to 
reproduction. The Court has also made clear that each person's zone of 
privacy encompasses reproduction under the care of a physician. Hence 
if H. R. 1644 declared it a crime to perform or attempt contraception, 
or in vitro fertilization, it would be said that such prohibition 
unconstitutionally infringes the right of privacy. Can the conclusion 
be different when the proscribed act is reproductive cloning? H. R. 
1644 itself states in Sec. 2, finding (8)(A), that ``cloning would take 
place within the privacy of the doctor-patient relationship.'' A 
measure of the intrusiveness of an anticloning statute is what would be 
adduced as evidence of the crime. When a mother as defendant denies 
bearing a clone, a prosecutor may seek a ``genetic audit'' comparing 
her child's DNA to that of the person allegedly cloned. In facilitating 
patents on DNA sequences, as in the Biotechnology Patent Protection Act 
of 1995, Congress has already opened the door to legal claims 
predicated on DNA audits. But now we are talking about incarceration of 
parents on the basis of such evidence. The fate of a criminal statute 
about reproduction lies in the courts. We ought not worsen its chances 
by overbreadth. Apart from this constitutional problem, as a matter of 
policy overbreadth here would foreclose such a negligible increment in 
illegal cloning as to make unreasonable an opportunity cost measured in 
relief of human suffering.
    What can wisely be done to tighten enforceability of an anticloning 
statute includes four provisions that I shall mention in a moment. 
First I must discuss the second argument for making nonreproductive 
SCNT illegal.

[b] Nonreproductive SCNT Not a Slippery Slope to Reproductive Cloning
    That argument begins with the prediction that use of 
nonreproductive SCNT in research and therapy will add to scientific 
knowledge about reproductive cloning, and that this will hasten the day 
when reproductive cloning becomes so reliable as to tempt us. 
Thereupon, it is suggested. we might repeal any statute forbidding it 
and bring upon ourselves its detrimental effects. Hence we are urged to 
forbid nonreproductive SCNT now.
    The slippery slope is an overworked metaphor. Not every 
decisionmaking surface is slippery. As the philosopher Richard M. Hare 
once observed, we decided to allow right turns from red traffic lights, 
and have not seen significantly more traffic accidents of right-turning 
vehicles. Now we discuss whether to allow reproductive cloning. For 
purposes of this discussion, we routinely abstract from the problem of 
defective clones, for we know that such a technical problem is solvable 
in principle. Even so, the public, so we are reliably informed, easily 
summons the collective will to prohibit cloning. That tells us that 
strong objections lie against even a perfectly reliable cloning 
procedure. Indeed it is argued that cloning may in various ways 
diminish respect for human life. Other objections to cloning gain 
expression in H. R. 1644, Sec. 2, findings [3]-[5]. If the day arrives 
when cloning's already anticipated reliability becomes actual, those 
objections will survive with undiminished force. It is not a foregone 
conclusion that if cloning becomes reliable, we shall approve it.
    On the other hand, we must be realistic in anticipating that even 
if reproductive cloning is declared illegal within various 
jurisdictions, someone may someday clone humans so as to gain, in the 
eyes of others, some advantage. In that event, competitors may follow 
suit. (This scenario has been broached concerning germ line genetic 
intervention in general. See my ``Norms for Patents Concerning Human 
and Other Life Forms,'' Theoretical Medicine 17: 279-314 [1996].) 
Competitors might migrate to jurisdictions where cloning is legal. 
Sovereign countries might themselves behave in the same way, rushing to 
follow the first rival who legalizes cloning, this for fear of being 
dominated by genetic superiors. The salient defect in the slippery 
slope argument against nonreproductive SCNT does not lie in the 
prediction that mercurial mankind will find reliable cloning 
irresistible, for that outcome is possible.
    Rather the slippery slope argument falls by virtue of its mistaken 
assumption that we can somehow attenuate or delay reproductive cloning 
if we preclude nonreproductive SCNT in the U. S. To state the obvious, 
what must happen to make reproductive cloning alluring is the 
successful performance of reproductive cloning. For such success, there 
must occur experiments and cloning attempts. This is a tough row to 
hoe, since it doubtless begins with a spate of deformed offspring. To 
produce healthy clones will require surmounting many challenges, among 
them the shorter interval before gene activation in humans than in 
sheep, the effects of aging and mutation on donated somatic cells, and 
cloning's failure to produce normal genetic imprinting. If progress 
against birth defects or later health problems of clones requires 
studies of development in utero, or even of development ex utero beyond 
fourteen days, the work of scientists using nonreproductive SCNT will 
not provide the solution. Scientists working on embryonic stem cells 
and cellular reprogramming culture embryos for only a matter of days. 
(In fact when an embryo reaches about day 10, if it does not implant in 
a uterus, it will so badly deform that it can no longer properly be 
called an embryo.) Suppose nonetheless that as mainstream scientists 
come to understand and publish accounts of how cellular reprogramming 
works, they inevitably issue knowledge dividends that can be cashed by 
those trying to perfect cloning. We are powerless to prevent such 
dividends. For instance, under authority of recent approval by 
Parliament, outstanding scientists in Oxford, Cambridge, and other 
British universities and research institutions will be using SCNT in 
research generally and in the study of cellular reprogramming in 
particular. So too will scientists elsewhere in the world. Their 
results will be reported in leading journals. New scientific knowledge 
disseminates rapidly. We cannot forestall improvements in cloning by 
any ban on SCNT in the U. S. A ban on nonreproductive SCNT can only 
strike a blow against those who suffer. Viewed from the perspective of 
years hence, the measure of damage wrought by a ban on use of SCNT in 
research would be the amount of suffering that could have been relieved 
if our extensive research enterprise had joined the worldwide effort to 
benefit from embryonic stem cells and cellular reprogramming.

    8. TIGHTENING A BAN ON REPRODUCTIVE CLONING WITHOUT OVERBREADTH

    The prohibition of proposed 18 U.S.C. Sec. 302(a) set forth in H. 
R. 1644 extends to SCNT that produces an embryo ``at any stage of 
development.'' This would bar all presently envisioned research use of 
SCNT, which produces and grows embryos to the blastocyst stage (day 5 
of development). The prohibition would bar SCNT even for therapy. Thus 
if scientists learn how to use eggs to accomplish autologous 
transplants, the clinical implementation of this boon for sick patients 
would be a crime. No comfort can be taken from mention in H. R. 1644 
(in Sec. 2, clause [9] and proposed 18 U.S.C. Sec. 302[d]) of research 
that the bill would not prohibit. We are told that the prohibition does 
not extend to ``nuclear transfer or other cloning techniques'' to 
produce, inter alia, ``cells other than human embryos.'' But the sundry 
methods other than SCNT for producing copies of various life forms--
methods that vary by life form even though some commentators (and the 
bill) lump them all under the name ``cloning''--are not within the 
scope of the prohibition in the first place.
    For the moral reasons that I have now recounted, if Congress were 
to thwart nonreproductive SCNT, that move would disserve morality. It 
would thwart our ability to fulfill our duty to aid those in need. If 
Congress chooses to legislate against reproductive cloning, I recommend 
the following four statutory features to preserve the availability of 
nonreproductive SCNT while tightening the proscription of reproductive 
cloning.
    (1) The offense may be defined as
        ``intentional transfer to a uterus of an embryo created by 
        somatic cell nuclear transfer.''
This would paint without using too broad a brush. ``Intentional'' 
assures that, as is appropriate in defining a crime, accidental conduct 
is not punished. Congress could consider making reckless transfer a 
lesser offense.
    (2) It may also be provided that
        ``A physician shall not effect intrauterine transfer of an 
        embryo unless the embryo was (i) created in a laboratory under 
        the physician's control or (ii) received from a licensed 
        physician accompanied by a certificate that the embryo was 
        created, without use of SCNT, in a laboratory under the latter 
        physician's control.''
This provision assures that fertility clinicians will know the means by 
which any embryos that they transfer to a uterus were created. It 
blocks the possibility of a woman inveigling an unwitting fertility 
clinician into a transfer into her of an SCNT-created embryo carried 
into the clinic by her. The transferability provision of (ii) allows a 
scenario such as the following. A woman engages an IVF procedure in 
Connecticut, then later moves to Oregon. By virtue of (ii), her frozen 
embryos may be sent to an Oregon fertility clinician for intrauterine 
transfer. She will not have to return to Connecticut for that 
procedure.
    (3) In the preamble of H. R. 1644 appears language about what 
``many'' think concerning morality. There exist many who believe many 
things. Rather than legislate morality, Congress could declare that it 
is prohibiting a procedure that would effectively constitute a clinical 
experiment with a probable success rate that is unacceptably low. This 
is consistent with H. R. 2172 in that the enactment becomes part of the 
federal scheme of regulation of drugs and medical devices.
    (4) Within the several states have already been enacted a potpourri 
of interdictions pertinent to this technological genre. We can expect 
more such statutes. Only preemptive federal legislation can assure a 
uniform norm, at least within the U. S. It behooves us, for the sake of 
the public health, to foster a reliable basis of expectations for those 
making decisions about where to direct research efforts. This 
especially applies to young scientists who wisely shun fields of work 
whose regulatory environment is unstable. (Here it may be added that we 
should be grateful for the commendable caution of senior scientists 
who, upon discovering the techniques of nonreproductive embryo 
creation, have evoked an open moral discussion. This follows a pattern 
in the recent history of science, of which the introduction of 
recombinant DNA technology is another example, in which the bright 
light of public exposure shines early on morally sensitive innovations 
by virtue of their discoverers' candor and alertness to moral 
questions.) For preemptive legislation, precedent obtains. We look to 
the Food and Drug Administration, not to the several states, for a 
national system of regulating drugs and medical devices.

                             9. CONCLUSION

    The burden of my testimony today is that it would disserve the 
cause of morality, disserve fulfillment of our duty to come to the aid 
of those who suffer, if any government action, whether a proscription 
of conduct or a constraint on the public purse, were to thwart 
nonreproductive SCNT. When I speak of morality, I refer to the 
intersection of the leading moral views of our time--including 
especially those sometimes imagined to hold otherwise--whose common 
kernel holds it virtuous to relieve suffering in actual lives when we 
can do so at no cost in potential lives.

    Mr. Bilirakis. Thank you very much, sir. And I apologize 
for cutting you off, but, you know, we have got to try to stay 
on point here.
    Dr. Newman?

                  STATEMENT OF STUART A. NEWMAN

    Mr. Newman. I thank the chairman for giving me the 
opportunity to testify today on this historical issue. My name 
is Stuart Newman. I have been a Professor of Cell Biology and 
Anatomy at New York Medical College since 1979 where I teach 
medical and graduate students, and direct a laboratory in 
developmental biology.
    This is a scientific field that studies embryo development, 
cloning, regeneration, and stem cells. My work on the 
development of the skeletal system in animals embryos has been 
supported over the past 25 years by grants from the National 
Science Foundation and the National Institutes of Health. I am 
currently the recipient of two Federal grants in this area.
    Since my student days, I have also been concerned with the 
uses to which scientific research is put. Having become 
convinced that scientists, who are beneficiaries of public 
resources, have a deep responsibility to anticipate what lies 
down the road in their own fields, and to themselves act as a 
resource for the public on the complex issues around 
applications of scientific research, I joined with other 
scientists, social-scientists, feminists, and progressive 
community advocates to found the Council for Responsible 
Genetics in the late 1970's.
    The Council is now the Nation's oldest organization 
scrutinizing and interpreting the new genetic technologies, and 
has worked for protecting genetic privacy, ending genetic 
discrimination, exercising caution in the development and 
dissemination of genetically engineered crops, banning 
biological weapons, and banning the introduction of inheritable 
genetic modifications into humans.
    This last issue relates to my own field of expertise. Over 
the past quarter century, I have seen laboratory findings, such 
as virus-based gene therapies and implantation of fetal tissues 
employed prematurely or inappropriately in humans through a 
process that, while often having noble motivations, has also 
been mixed with appreciable amounts of wishful thinking, hype, 
and greed.
    Last year, the Council issued the Genetic Bill of Rights, 
which is appended to my written testimony, which touches on all 
the above issues.
    The last of the 10 listed Rights states, ``All people have 
the right to have been conceived, gestated, and born without 
genetic manipulation.''
    This position arose, in part, from scientific consideration 
of the inherent uncertainties in performing such manipulations, 
which include cloning. Reviewing the animal studies in this 
area led Professor Rudolf Jaenisch, of the Massachusetts 
Institute of Technology, to state, ``I believe there probably 
isn't a normal clone around.''
    Our position also emanated from the fact that any person 
engineered in this fashion will be an experiment subject to the 
kinds of disappointments associated with experiments failing to 
meet expectations.
    A grim aspect of this experimental approach to producing 
people would be the devaluation of unfavorable outcomes if, as 
in cloning, the same procedure could be performed repeatedly 
until a desired outcome was reached.
    In addition, while the Council for Responsible Genetics is 
unequivocally committed to a woman's right not to proceed with 
a pregnancy, if that is her choice, we, along with many 
feminists and others who affirm this right, are concerned that 
reproductive choice is increasingly being taken to include the 
right to genetically improve the next generation.
    If this is allowed, it may soon lead to baby design and 
reproductive boutiques. Eugenics, defining humans as 
genetically superior or inferior, and implementing those 
definitions, has a horrific history that we dare not repeat.
    In line with the Genetic Bills of Rights, and in light of 
new experimental results and proposals to generate and modify 
human embryos, the Council for Responsible Genetics issued a 
policy statement on human embryo research earlier this month.
    The statement is appended, and I will summarize it here. 
The Council for Responsible Genetics opposes the utilization of 
human eggs and embryos for experimental manipulations and as 
items of commerce.
    We, therefore, call for a ban on the buying or selling of 
human eggs or embryos, and the manipulation of any and all 
human eggs or embryos by transfer of cells, nuclei, cytoplasm, 
mitochondria, chromosomes, or isolated DNA or RNA molecules of 
human or non-human origin.
    These bans are to apply whether or not the embryos are to 
be implanted and gestated. No human embryo is to be produced 
solely for purposes of research. These bans are to apply, 
irrespective of the sources of funding, whether public or 
private.
    It is essential that the United States join the many other 
nations that have banned reproductive cloning. But note that we 
call for a ban not just on reproductive cloning, but on so-call 
therapeutic cloning as well.
    That is, even if a cloned embryo is not intended for 
gestation, we are opposed to its manufacture. We have become 
convinced that if a construction of modified or cloned human 
embryos is permitted, there will be little standing in the way 
of using them for reproductive purposes.
    At that point, gestation of cloned embryos would easily 
become defined as a matter of individual choice.
    The bans that we call for would not--would, in no way, 
curtail the option to employ in vitro fertilization for 
reproductive purposes. Moreover, while we do not explicitly 
reject the production of embryo stem cells from excess embryos 
produced by in vitro fertilization, my own view is that other 
scientific avenues, specifically adult stem cell research, have 
greater promise.
    A group of my colleagues at New York Medical College 
recently published on the repair of damaged mouse hears with 
adult mouse stem cells. I know of no comparable successes with 
embryo stem cells in the mouse, even though such cells have 
been available and researched for more than a decade.
    Any objective view of the relevant animal research would 
conclude that adult stem cells are the better bet.
    As recently as a year or 2 ago, advocates of human cloning 
were careful to state that an embryo produced by cloning had no 
less dignity as a potential human than an embryo produced by 
fertilization.
    Now that some technical advance is seen in making donor-
matched stem cells from cloned embryos, distinctions are being 
made by interested parties between producing embryos for 
research by fertilization still not acceptable, and doing so by 
cloning, now acceptable.
    If we let purely technical and utilitarian considerations 
determine what is acceptable in human reproduction and 
production, in a few brief years, human error will assuredly 
lead to production of humans with avoidable errors.
    As a scientist, I am personally concerned that the products 
of our research not be used for dangerous and divisive 
purposes, which would bring disrepute to science and undermine 
our ability to do beneficial work.
    As these new technologies proliferate, the question 
continually arises as to where to draw the line. I am convinced 
that the bio-technology industry does not want any line to be 
drawn that would curtail any of their activities.
    The Greenwood bill, with its limited moratorium on 
reproductive cloning, will just be an opportunity to soften up 
public opinion, even on this issue. I say----
    Mr. Bilirakis. Please summarize, Doctor. I would appreciate 
it.
    Mr. Newman. I say this with regret, as a life-long 
progressive and a democratic voter. Because embryo cloning 
will, with virtual certainty, lead to the production of 
experimental human beings, both as a scientist and a citizen, I 
urge you to draw the line here.
    [The prepared statement of Stuart A. Newman follows:]

 Prepared Statement of Stuart A. Newman, Professor of Cell Biology and 
                   Anatomy, New York Medical College

    My name is Stuart Newman. I have been a professor of Cell Biology 
and Anatomy at New York Medical College since 1979, where I teach 
medical and graduate students and direct a laboratory in developmental 
biology. This is the scientific field that studies embryo development, 
cloning, regeneration, and stem cells. My work on the development of 
the skeletal system in animal embryos has been supported over the past 
25 years by grants from the National Science Foundation and the 
National Institutes of Health. I am currently the recipient of two 
Federal grants.
    Since my student days I have also been concerned with the uses to 
which scientific research is put. My doctoral research in chemistry at 
the University of Chicago was conducted at the James Franck Institute. 
Professor James Franck was a Nobel prize winning atomic physicist who 
was the principal author of the May 1945 Franck Report. This document 
anticipated the horrors of nuclear weapons and was the first call by 
scientists for international controls over these weapons. The Franck 
report was a landmark in scientific responsibility and its message 
ultimately prevailed.
    Having become convinced that scientists, who are beneficiaries of 
public resources, have a deep responsibility to anticipate what lies 
down the road in their own fields and to themselves act as a resource 
for the public on the complex issues around applications of scientific 
research, I joined with other scientists, social scientists, feminists 
and community advocates to found the Council for Responsible Genetics 
in the late 1970s. The Council is now the Nation's oldest organization 
scrutinizing and interpreting the new genetic technologies, and has 
worked for protecting genetic privacy, ending genetic discrimination, 
exercising caution on the development and dissemination of genetically 
engineered crops, banning biological weapons, and banning the 
introduction of inheritable genetic modifications into humans. This 
last issue relates to my own field of expertise. Over the past quarter 
century I have seen laboratory findings such as virus-based gene 
therapies and implantation of fetal tissues employed prematurely or 
inappropriately in humans through a process that while often having 
noble motivations has also been mixed with appreciable amounts of 
wishful thinking, hype and greed.
    Last year the Council issued the Genetic Bill of Rights (appended) 
which touches on all the above issues. The last of the ten listed 
Rights states:
    All people have the right to have been conceived, gestated, and 
born without genetic manipulation.
    This position arose, in part, from scientific consideration of the 
inherent uncertainties in performing such manipulations, which include 
cloning. Reviewing the animal studies in this area led Professor Rudolf 
Jaenisch of the Massachusetts Institute of Technology to state ``I 
believe there probably isn't a normal clone around.'' Our postion also 
emanated from the fact that any person engineered in this fashion will 
be an experiment, subject to the kinds of disappointments associated 
with experiments failing to meet expectations. A grim aspect of this 
experimental approach to producing people would the devaluation of 
``unfavorable'' outcomes if, as in cloning, the same procedure could be 
performed repeatedly until a desired outcome was reached. In addition, 
while the Council for Responsible Genetics is unequivocally committed 
to women's right not to proceed with a pregnancy if that is her choice, 
we, along with many feminists and others who affirm this right, are 
concerned that ``reproductive choice'' is increasingly taken to include 
the right to genetically improve the next generation. If this is 
allowed it may soon lead to baby design and reproductive boutiques. 
Eugenics, defining humans as genetically superior or inferior and 
implementing those definitions, has a horrific history that we dare not 
repeat.
    In line with the Genetic Bill of Rights, and in light of new 
experimental results and proposals to generate and modify human 
embryos, the Council for Responsible Genetics issued a policy statement 
on human embryo research earlier this month. The statement is appended 
and I will summarize it here:

 The Council for Responsible Genetics opposes the utilization 
        of human eggs and embryos for experimental manipulations and as 
        items of commerce.
 We therefore call for a ban on the buying or selling of human 
        eggs or embryos, and the manipulation of any and all human eggs 
        or embryos by transfer of cells, nuclei, cytoplasm, 
        mitochondria, chromosomes, or isolated DNA or RNA molecules of 
        human or non-human origin.
 These bans are to apply whether or not the embryos are to be 
        implanted and gestated.
 No human embryo is to be produced solely for purposes of 
        research.
 These bans are to apply irrespective of the sources of 
        funding, whether public or private.
    It is essential that the United States join the many other nations 
that have banned reproductive cloning. But note that we call for a ban 
not just on reproductive cloning but on so-called ``therapeutic 
cloning'' as well. That is, even if a cloned embryo is not intended for 
gestation we are opposed to its manufacture. We have become convinced 
that if the construction of modified or cloned embryos is permitted 
there will be little standing in the way of using them for reproductive 
purposes. At that point gestation of cloned embryos would easily become 
defined as a matter of individual choice.
    The bans that we call for would in no way curtail the option to 
employ in vitro fertilization for reproductive purposes. Moreover, 
while we do not explicitly reject the production of embryo stem cells 
from excess embryos produced by in vitro fertilization, my own view is 
that other scientific avenues, specifically adult stem cell research, 
have greater promise. A group of my colleagues at New York Medical 
College recently published on the repair of damaged mouse hearts with 
adult mouse stem cells. I know of no comparable successes with embryo 
stems cells in the mouse, even though such cells have been available 
and researched for more than a decade. Any objective view of the 
relevant animal research would conclude that adult stem cells are the 
better bet.
    As recently as a year or two ago advocates of human cloning were 
careful to state that an embryo produced by cloning had no less dignity 
as a potential human than an embryo produced by fertilization. Now that 
some technical advantage is seen in making donor-matched stem cells 
from cloned embryos, distinctions are being made by interested parties 
between producing embryos for research by fertilization (still not 
acceptable) and doing so by cloning (now acceptable). If we let purely 
technical and utilitarian considerations determine what is acceptable 
in human reproduction and production, in a few brief years human error 
will assuredly lead to the production of humans with avoidable errors.
    As a scientist, I am personally concerned that the products of our 
research not be used for dangerous and divisive purposes, which would 
bring disrepute to science and undermine our ability to do beneficial 
work. As these new technologies proliferate the question continually 
arises as to ``where to draw the line.'' Because embryo cloning will, 
with virtual certainty, lead to the production of ``experimental'' 
human beings, both as a scientist and a citizen I urge you to draw the 
line here.
                               Appendix I

     COUNCIL FOR RESPONSIBLE GENETICS STATEMENT ON EMBRYO RESEARCH
                               JUNE 2001

    The Council for Responsible Genetics unequivocally supports a 
woman's right to make her own reproductive decisions. However, we 
oppose the utilization of human eggs and embryos for experimental 
manipulations and as items of commerce because of the potential for 
eugenic applications and health risks to women and their offspring.
    The Council for Responsible Genetics therefore calls for a ban on 
the buying or selling of human eggs or embryos, and the manipulation of 
any and all human eggs or embryos by transfer of cells, nuclei, 
cytoplasm, mitochondria, chromosomes, or isolated DNA or RNA molecules 
of human or non-human origin.
    This ban would apply whether or not the embryos are to be implanted 
and gestated and irrespective of the sources of funding, whether public 
or private.
    No human embryo is to be produced solely for purposes of research.

                              Appendix II

                       THE GENETIC BILL OF RIGHTS

                                Preamble

    Our life and health depend on an intricate web of relationships 
within the biological and social worlds. Protection of these 
relationships must inform all public policy.
    Commercial, governmental, scientific and medical institutions 
promote manipulation of genes despite profound ignorance of how such 
changes may affect the web of life. Once they enter the environment, 
organisms with modified genes cannot be recalled and pose novel risks 
to humanity and the entire biosphere.
    Manipulation of human genes creates new threats to the health of 
individuals and their offspring, and endangers human rights, privacy 
and dignity.
    Genes, other constituents of life, and genetically modified 
organisms themselves are rapidly being patented and turned into objects 
of commerce. This commercialization of life is veiled behind promises 
to cure disease and feed the hungry.
    People everywhere have the right to participate in evaluating the 
social and biological implications of the genetic revolution and in 
democratically guiding its applications.
    To protect our human rights and integrity and the biological 
integrity of the earth, we, therefore, propose this Genetic Bill of 
Rights.

                       THE GENETIC BILL OF RIGHTS

    1. All people have the right to preservation of the earth's 
biological and genetic diversity.
    2. All people have the right to a world in which living organisms 
cannot be patented, including human beings, animals, plants, 
microorganisms and all their parts.
    3. All people have the right to a food supply that has not been 
genetically engineered.
    4. All indigenous peoples have the right to manage their own 
biological resources, to preserve their traditional knowledge, and to 
protect these from expropriation and biopiracy by scientific, corporate 
or government interests.
    5. All people have the right to protection from toxins, other 
contaminants, or actions that can harm their genetic makeup and that of 
their offspring.
    6. All people have the right to protection against eugenic measures 
such as forced sterilization or mandatory screening aimed at aborting 
or manipulating selected embryos or fetuses.
    7. All people have the right to genetic privacy including the right 
to prevent the taking or storing of bodily samples for genetic 
information without their voluntary informed consent.
    8. All people have the right to be free from genetic 
discrimination.
    9. All people have the right to DNA tests to defend themselves in 
criminal proceedings.
    10. All people have the right to have been conceived, gestated, and 
born without genetic manipulation.

    [Spring, 2000--Copyright, The Council for Responsible Genetics]

    Mr. Bilirakis. Thank you very much, Doctor.
    Mr. Perry?

                    STATEMENT OF DANIEL PERRY

    Mr. Perry. Chairman Bilirakis and members of the committee, 
I very much appreciate the opportunity to come before this 
committee today to address the promise and the peril 
surrounding cloning technologies.
    My name is Daniel Perry, and I am the Executive Director of 
the Alliance for Aging Research. And as the head of a not-for-
profit group eager to find cures, preventions and overall 
better health and vitality for the elderly, my views on 
research reflect the medical needs of the growing population of 
older Americans.
    The Alliance for Aging Research works to stimulate 
academic, governmental, and private sector research into the 
chronic diseases of human aging.
    Our organization also takes up the cause of the vast 
majority of Americans who fervently wish to benefit from 
scientific discoveries that improve the human experience with 
aging.
    Our survey research tells us that most Americans believe 
the Federal Government has a critical role to play to prepare 
the way for new medical breakthroughs and to hurry applications 
of science in health care in order to relieve human suffering 
and improve the quality of life for their family members and 
for themselves.
    On behalf of a growing American constituency for healthy 
aging, powered by the aging of the Baby Boom generation, I am 
here to express a concern to this committee.
    The Alliance for Aging Research believes that broadly 
drafted legislation intended to prevent the cloning of a human 
being could have the effect of derailing promising lines of 
health research, which could ultimately benefit older 
Americans, their families, and the Nation as a whole.
    Every day in America, another 6,000 people celebrate their 
65th birthday. And just behind them, the Baby Boomers are 
cruising into their 50's in even greater numbers.
    In just 10 years, the post-World War babies will begin 
swelling the Medicare rolls. In less than 30 years, the whole 
of our largest generation will be old enough to receive health 
care paid by Medicare.
    If, during these years just ahead, we fail to reduce the 
threat of age-related diseases, the U.S. will encounter 
staggeringly high economic costs, as well as we will face a 
toll on human lives due to mounting debts and disabilities from 
cancer, stroke, macular degeneration, joint and bone diseases, 
Alzheimers and Parkinson's disease.
    If we stifle future medical breakthroughs and must end up 
managing the aging of 75 million Baby Boomers with today's 
halfway technologies, we risk economic and social catastrophe 
within a generation.
    Fortunately, we can choose a wiser, more humane, and 
ultimately less costly alternative. That alternative is to 
encourage rapid advances and applications from medical and 
behavioral research to prevent much of the declining health 
status we now associate with old age.
    There is good reason to hope that scientific understanding 
of the mechanisms of aging within the--within our own cells, 
genes, and proteins may ultimately permit a significant delay 
in disabilities caused by diseases of aging.
    Regenerative medicine is the concept of harnessing powers 
of growth and healing within our own bodies at a fundamental 
level of human biology.
    We can look forward to future health technologies that use 
stem cells, engineered tissues, grown factors, and other tools 
of regenerative medicine. It is a growing possibility that 
physicians 1 day will be able to replace damaged tissues using 
a person's own cells to treat blindness, spinal cord injury, 
coronary artery disease, diabetes, and other diseases that 
result from injured, malfunctioning, or aged cells.
    Scientists involved in this research say that human somatic 
cell nuclear transfer is an enabling technology that can be 
used to generate healthy cells and tissues for repair or 
replacement in a vast variety--in a vast array of medical 
applications.
    To deny our aging population the opportunity to benefit 
from this research would be a tragic reversal of our recent 
biomedical progress toward permanent cure of diseases that 
compromise quality of life, and which account for so much of 
our Nation's health care expenditures.
    A prominent member of the Alliance's Science Advisory Board 
is Dr. George M. Martin of the University of Washington in 
Seattle. Dr. Martin writes, ``Those of us in the Alzheimers 
Disease Research Center are using cell cultures in attempts to 
discover the fundamental molecular mechanisms that lead to 
differing rates of neuronal damage in dementias of the 
Alzheimers type. For obvious reasons, we cannot work with 
samples of brain tissues from living subjects.''
    ``We are forced to utilize surrogate cells, typically 
fibroblasts that can be grown from tiny skin biopsies. The 
ability to reprogram such cells so that they can exhibit the 
properties of the donor's neural cells would represent an 
enormous advance.''
    I want to make it abundantly clear that the Alliance for 
Aging Research is strongly opposed to cloning of a human being. 
To my knowledge, that position is supported by virtually every 
responsible scientific and health advocacy organization in the 
United States.
    The Alliance does support responsible and sound biomedical 
research, including emerging cellular therapies which could 
lead to the development of treatments for cures for scores of 
age-related diseases.
    We urge this committee to lead the way by drawing a clear 
distinction between cloning for human reproductive purposes, 
which we oppose, and cloning cells for human therapeutic 
purposes.
    Millions of patients and families, organizations, and 
advocates for health and scientific research across the land 
would applaud that kind of leadership.
    Some measures before this committee propose to avoid the 
cloning of a human being by bringing into the laboratory the 
full police powers of the Federal Government.
    These intended anti-cloning proposals would criminalize 
laboratory techniques that otherwise might help us find cures 
for diseases such as cancer and Alzheimers. To threaten 
university scientists with massive fines and prison sentences 
would constitute a massive and unprecedented assault on 
research.
    Mr. Bilirakis. Please summarize, Mr. Perry.
    Mr. Perry. I will, Mr. Chairman. I would cast a pall over 
the conduct of academic science, and it would diminish and 
contradict the accomplishments of a U.S. Congress that, even 
now, is working nobly to double research funding to through the 
National Institutes of Health.
    Mr. Chairman, it is likely that we will continue to be 
confronted with scientific advances that pose difficult social 
and ethical questions. Congress is at its best when its actions 
are informed and enriched by slow and careful debate, by advice 
from expert sources, and when taken in respect for minority 
opinion.
    On behalf of the Alliance for Aging Research, I think the 
committee again for its deliberation and the opportunity to 
speak to this issue.
    [The prepared statement of Daniel Perry follows:]

 Prepared Statement of Daniel Perry, Executive Director, Alliance for 
                             Aging Research

    Chairman Bilirakis, and Members of the Committee: Thank you for the 
opportunity to come before this committee today to address the promise 
and perils surrounding cloning technologies.
    As the head of a not-for-profit group eager to find cures, 
preventions and overall better health and vitality for the elderly, my 
views on research reflect the medical needs of the growing population 
of older Americans.
    The Alliance for Aging Research works to stimulate academic, 
governmental and private sector research into the chronic diseases of 
human aging. Our organization takes up the cause of the vast majority 
of Americans who fervently wish to benefit from scientific discoveries 
that improve the human experience with aging. Our survey research tells 
us that most Americans believe the federal government has a critical 
role to play to prepare the way for new medical breakthroughs and to 
hurry applications of science in health care in order to relieve human 
suffering and improve the quality of life for their family members and 
for themselves.
    On behalf of a growing American constituency for healthy aging--
powered by the aging of the Baby Boom generation--I am here to express 
a concern to the committee. The Alliance for Aging Research believes 
that broadly drafted legislation, intended to prevent the cloning of a 
human being, could have the effect of derailing promising lines of 
health research which could ultimately benefit older Americans, their 
families and the nation as a whole.
    Every day in America another 6,000 people celebrate a 65th 
birthday. Just behind them, the Baby Boomers are cruising into their 
50s in even greater numbers. In just 10 years the post World War babies 
will begin swelling the Medicare roles.
    In less than 30 years, the whole of our largest generation will be 
old enough to receive health care paid by Medicare. If, during these 
years just ahead, we fail to reduce the threat of age-related diseases, 
the U.S. will encounter staggeringly high economic costs, as well as we 
will face a toll on human lives due to mounting deaths and disabilities 
from cancer, stroke, macular degeneration, joint and bone diseases, 
Alzheimer's and Parkinson's diseases.
    If we stifle future medical breakthroughs, and must manage the 
aging of 75 million Baby Boomers with today's halfway health 
technologies, we risk economic and social catastrophe within a 
generation.
    Fortunately, we can choose a wiser, more humane, and ultimately 
less costly alternative. That alternative is to encourage rapid 
advances and applications from medical and behavioral research to 
prevent much of the declining health status we now associate with old 
age.
    There is good reason to hope that scientific understanding of the 
mechanisms of aging within our own cells, genes and proteins may 
ultimately permit a significant delay in disabilities caused by 
diseases of aging.
    Regenerative medicine is the concept of harnessing powers of growth 
and healing within our own bodies at a fundamental level of human 
biology. We can look forward to future health technologies that use 
stem cells, engineered tissues, growth factors and other tools of 
regenerative medicine. It's a growing possibility that physicians one 
day will be able to replace damaged tissues, using a person's own cells 
to treat blindness, spinal cord injury, coronary artery damage, 
diabetes and other diseases that result from injured, malfunctioning or 
aged cells.
    Scientists involved in this research say that human somatic cell 
nuclear transfer is an enabling technology that can be used to generate 
healthy cells and tissues for repair or replacement in a vast array of 
medical applications. To deny our aging population the opportunity to 
benefit from this research would be a tragic reversal of recent 
biomedical progress toward permanent cure of diseases that compromise 
quality of life, and which account for so much of our nation's health 
care expenditures.
    A prominent member of the Alliance's Science Advisory Board is Dr. 
George M. Martin of the University of Washington in Seattle. Dr. Martin 
has written: ``those of us in the Alzheimer's Disease Research Center 
are using cell cultures in attempts to discover the fundamental 
molecular mechanisms that lead to differing rates of neuronal damage in 
dementias of the Alzheimer type and related disorders. For obvious 
reasons, we cannot work with samples of brain tissue from living 
subjects. We are forced to utilize surrogate cells, typically 
fibroblasts that can be grown from tiny skin biopsies. The ability to 
reprogram such cells so that they can exhibit the properties of the 
donor's neural cells would represent an enormous advance.''
    I want to make it abundantly clear that the Alliance for Aging 
Research is strongly opposed to the cloning of a human being. To my 
knowledge that position is supported by virtually every responsible 
scientific and health advocacy organization in the U.S. The Alliance 
does support responsible and sound biomedical research, including 
emerging cellular therapies, which could lead to the development of 
treatments or cures for scores of age-related diseases and 
disabilities.
    We urge this committee to lead the way by drawing a clear 
distinction between cloning for human reproductive purposes--which we 
oppose--and cloning cells for human therapeutic purposes. Millions of 
patients and families, organizations and advocates for health and 
scientific research across the land would applaud that kind of 
leadership.
    Some measures before this committee propose to avoid the cloning of 
a human being by bringing into the laboratory the full police powers of 
the federal government. These intended anti-cloning proposals would 
criminalize laboratory techniques that otherwise might help us find 
cures for diseases such as cancer and Alzheimer's.
    To threaten university scientists with massive fines and prison 
sentences would constitute a massive and unprecedented assault on 
research. It would cast a pall over the conduct of academic science. 
And it would diminish and contradict the accomplishments of a U.S. 
Congress that even now is working nobly to double research funding 
through the National Institutes of Health.
    At this very moment, tens of millions of older Americans are 
suffering from Alzheimer's, Parkinson's, cancer, diabetes and chronic 
health problems of aging. Not only are they suffering, but their 
families and caregivers are suffering too, and they are hoping that 
scientists will find cures for these devastating diseases and 
conditions while there is still time. They are in a hurry for answers, 
and they look to leaders like you to be their advocates and protectors.
    Mr. Chairman, it is likely that we will continue to be confronted 
with scientific advances that pose difficult social and ethical 
questions. The present momentum in the life sciences, and the profound 
implications of what we are learning, will inevitably raise public 
concerns.
    There is ample time for policymakers, ethicists, scientists, and 
patient groups to discuss options that would prevent human cloning, but 
which would preserve promising health research. Congress is at its best 
when its actions are informed and enriched by slow and careful debate, 
by advice from expert sources, and when taken in respect for minority 
opinion.
    In the case of proposals to limit any of the tools for scientific 
and medical research, the need for prudence is especially important, 
due to the technical complexity of the issues and the consequences for 
public health and well being.
    On behalf of the Alliance for Aging Research, I thank the committee 
again for its deliberations and for the opportunity to speak to this 
issue.

    Mr. Bilirakis. Thank you so much, Mr. Perry.
    Ms. Norsigian?

                   STATEMENT OF JUDY NORSIGIAN

    Ms. Norsigian. Thank you, Chairman Bilirakis and members of 
the committee for the opportunity to speak. My name is Judy 
Norsigian. I am Executive Director of the Boston Women's Health 
Book Collective, which is best known for the landmark women's 
health and sexuality book entitled, ``Our Bodies, Ourselves,'' 
published first in 1970.
    There are now 4.5 million copies in print in 20 languages 
around the world, with 10 on the way. The most recent edition 
is entitled, ``Our Bodies, Ourselves for the New Century.'' And 
there is a new Spanish language cultural adaptation that 
appeared last year.
    Our organization has a long track record in the area of 
women's health and reproductive rights. And I personally serve 
on the Board of Directors of a public interest organization 
devoted to medical research issues.
    And I also have served in the capacity of advisor and on 
some planning committees for the Office of Research on Women's 
Health at the National Institutes of Health.
    I am deeply interested in many avenues of research. I would 
like to endorse the comments by Drs. Kass and Newman, so I will 
try not to repeat them again.
    Our organization joins many other national and 
international organizations in calling for a universal ban on 
human reproductive cloning. As we said, allowing for cloning 
would open the door to treating our children like manufactured 
objects. It would pave the way for an unprecedented new form of 
eugenics. And it really would serve no justifiable purpose.
    Supporters of women's health and reproductive rights have 
particular reasons to oppose human cloning. Those who would 
encourage human cloning appear oblivious to the enormous risks 
to women and children's health that cloning would pose. And 
there is no way that human cloning could be developed without, 
in effect, mass experimentation on human beings, women and 
children, of a sort that has been outlawed since the 
formulation of the Nuremburg Principles following World War II.
    For these reasons, we call for a permanent ban on the 
creation of cloned human beings. And our opposition to human 
cloning in no way diminishes our support for a woman's right to 
safe, legal, and accessible contraception and abortion 
services.
    Some medical researchers support the creation of clonal 
human embryos for experimental purposes leading to potential 
therapeutic applications.
    While many women's health advocates may not, in principle, 
oppose the use of human embryos for valid medical research, 
including their use to generate embryonic stem cells, they do 
oppose the creation of clonal human embryos.
    To allow this procedure would make it all but impossible to 
enforce the ban on the creation of fully formed human clones. I 
think that point has been made. There is no such thing as an 
enforceable ban, and I won't repeat that.
    Further, it would open the door to other, more profound 
forms of human genetic manipulation. And for these reasons, we 
call for a moratorium on the creation of clonal human embryos 
for research purposes.
    During such a period, the many non-controversial 
alternatives for these purposes could be explored.
    I also want to point out that we, along with many others, 
have never taken the position that a woman or a man has a right 
to biological parenthood and, the corollary position that would 
follow, an unlimited right to pursue any type of reproductive 
technology that may lead to biological parenthood.
    There are many reasons why such a position would be 
untenable from the basic view of health and safety alone. More 
than 30 countries worldwide already have banned the creation of 
human clones and/or imposed constraints on the creation of 
clonal embryos.
    It is time for the United States to do likewise. The 
majority of women's health and reproductive advocates want this 
to happen as the future of our common humanity is at stake.
    And I do want to say that my interpretation of the Weldon-
Stupak bill is that it goes just the right distance. It will 
prevent the things we don't want to have happened from 
happening, and it will allow appropriate clonal techniques to 
proceed ahead with somatic cells.
    And a good deal of the therapeutic benefits that we would 
like to see developed can be developed while we oppose the 
development of clonal human embryos. Thank you very much.
    [The prepared statement of Judy Norsigian follows:]

   Prepared Statement of Judy Norsigian, Executive Director, Boston 
                     Women's Health Book Collective

    I am Judy Norsigian, the Executive Director of the Boston Women's 
Health Book Collective (BWHBC), co-authors of Our Bodies, Ourselves, 
the most widely read book about women's health and sexuality since it 
was first published in 1970. There are now 4\1/2\ million copies in 
print in 20 languages around the world, with 10 more editions on the 
way. The 7th and latest English language edition in the United States 
is entitled Our Bodies, Ourselves for the New Century. The Spanish 
language cultural adaptation--Nuestros Cuerpos, Nuestras Vidas--was 
published last year. Our organization has also produced similar books 
for teenagers and for older women and sustains a variety of advocacy 
and activist efforts related to the health of women, families and 
communities. We have a long track record in the field of reproductive 
rights and reproductive health.
    The BWHBC joins many other national and international organizations 
in calling for a universal ban on human reproductive cloning. To allow 
the creation of human clones would open the door to treating our 
children like manufactured objects. It would violate deeply and widely 
held values concerning human individuality and dignity. It would pave 
the way for unprecedented new forms of eugenics. And it would serve no 
justifiable purpose.
    Supporters of women's health and reproductive rights have 
particular reasons to oppose human cloning. Those who encourage human 
cloning appear oblivious to the enormous risks to women and children's 
health that human cloning would pose. There is no way that human 
cloning could be developed without, in effect, mass experimentation on 
human beings--women and children--of a sort that has been outlawed 
since the formulation of the Nuremberg Principles following World War 
II.
    Further, cloning advocates are seeking to appropriate the language 
of reproductive rights to support their case. This is a travesty. There 
is an immense difference between seeking to end an unwanted pregnancy 
and seeking to create a genetic duplicate human being. Our opposition 
to human cloning in no way diminishes our support for a woman's right 
to safe, legal, and accessible contraception and abortion services.
    For these reasons, we call for a permanent ban on the creation of 
cloned human beings.
    Some medical researchers support the creation of clonal human 
embryos for experimental purposes leading to potential therapeutic 
applications. While we do not in principle oppose the use of human 
embryos for valid medical research, including their use to generate 
embryonic stem cells, we do oppose the creation of clonal human 
embryos. To allow this procedure would make it all but impossible to 
enforce the ban on the creation of fully formed human clones. Further, 
it would open the door to other, more profound forms of human genetic 
manipulation. For these reasons, we call for at least a moratorium on 
the creation of clonal human embryos for research purposes. During such 
a period the many non-controversial alternatives to using clonal 
embryos for these purposes could be explored.
    More than thirty countries worldwide have already banned the 
creation of human clones and/or imposed constraints on the creation of 
clonal embryos. It is time for the United States to do likewise. The 
vast majority of women's health and reproductive rights advocates want 
this to happen. The future of our common humanity is at stake.

    Mr. Bilirakis. Thank you very much, Ms. Norsigian.
    Mr. Doerflinger?

               STATEMENT OF RICHARD M. DOERFLINGER

    Mr. Doerflinger. Thank you. I will forego the opportunity 
to debate Dr. Guenin on what Catholicism means unless someone 
raises it in a question.
    The only Catholic quote I will use is this statement from 
the Pontifical Academy of Life, which advises the Holy See, 
``In the cloning process, the basic relationships of the human 
person are perverted; filiation, consanguinity, kinship, 
parenthood. A woman can be the twin sister of her mother, lack 
a biological father, and be the daughter of her grandmother. In 
in vitro fertilization''--I am sorry, ``In vitro fertilization 
has already led to the confusion of parentage, but cloning will 
mean the radical rupture of these bonds.''
    By reducing human reproduction to simple manufacture in the 
laboratory, cloning reduces the new human being to a product 
and then to a commodity, and obviously opens the door to these 
human beings, at any age, being treated as mere research 
fodder, as second-class human beings.
    We all agree that in the present state of science, it would 
be irresponsible to try to produce a live-born child by 
cloning, as evidenced by the 95 to 99 percent death rate of 
cloned embryos in animal trials.
    I would note, though, that if people think that the human 
embryo has no status, is chopped liver, then I don't know why 
even my pro-choice colleagues agree that that 95 to 99 percent 
death rate, most of which happens at the embryonic and fetal 
stage, is a problem.
    I think the abortion issue and its politics have really 
confused the fact that biologically, we are speaking about a 
being that is a member of the family with us, and is a member 
of the human species.
    And the fact that in our current legal situation, there are 
other considerations involving competing rights of a pregnant 
woman that have been found to override those interests, does 
not make the human embryo into a goldfish, as the International 
Chairman of the Juvenile Diabetes Foundation has been known to 
say.
    Now, I want to go into the problem that some people want to 
solve the problem of 95 to 99 percent death rate by simply 
jacking the death rate up to 100 percent for research purposes. 
I don't think that is the right direction.
    I think that if you are--if you are going to make new human 
beings in such a way that the death rate is anywhere between 95 
and 100 percent, it would be a very good idea to decide not to 
create those human beings.
    But I would like to cite particularly the Greenwood bill. I 
agree with Dr. Kass about what the Greenwood bill does, except 
I think he has been too kind. I think the Greenwood bill 
doesn't ban anything at all in the area of reproductive 
cloning.
    And Dr. Kass has set forth a number of scenarios in which 
one person would make the embryo and another transfer it, or 
ship it, and so on. And those are all true.
    But let us take the very simplest, most straightforward 
case of outright reproductive cloning with one researcher. Now, 
that researcher is authorized by this bill, and gets a 
registered laboratory, to do research in cloning, presumably 
including research to see how efficient the cloning process can 
be made in the laboratory to prepare for the day, 10 years 
hence, when all bans drop away, and the safety record is 
sufficient to argue that we should do reproductive cloning.
    Now, on that basis alone, I would call this bill the 
Railian agenda with a speed bump. But let us see what happens 
in the meantime.
    He makes these embryos in the laboratory to test the 
efficiency of the process. This time, the embryos look really 
good; they look a lot more viable than in the past. So, he now 
intends to initiate a pregnancy with them. That is the way this 
would happen.
    You would never know in advance which embryos are going to 
be good enough to try a pregnancy with. And when he initiates 
that pregnancy, he is acting fully in accord with this bill.
    He is not evading the law. He is obeying the law because 
his intent to implant happened after he made the embryos.
    So, if this bill does nothing to stop reproductive cloning, 
what does it do? It does two things. First, it bans any State 
from trying to ban reproductive or research cloning by saying 
that the only thing a new State law may do is exactly what this 
bill does, which is nothing to stop cloning.
    The second thing it does is to actually inject the Federal 
Government in a much more active way into the licensing, the 
registration, of laboratories to do that process which Mr. 
Greenwood quoted me a moment ago, as ``morally abhorrent and 
medically questionable,'' except that he was stating that as 
the position of the Catholic Church. And actually, I was 
paraphrasing President Clinton, Senator Specter, the NIH, and 
The Washington Post and The Chicago Sun Times.
    This is not something that has been a dividing matter 
between pro-life and pro-choice people. Just to cite The 
Washington Post, ``The creation of human embryos specifically 
for research that will destroy them is unconscionable . . . 
[I]t is not necessary to be against abortion rights, or to 
believe human life literally begins at conception, to be deeply 
alarmed by the notion of scientists purposely causing 
conceptions in a context entirely divorced from even the 
potential of reproduction.''
    Likewise, The Chicago Sun Times has editorialized that 
creating research embryos solely for research that will kill 
them is an idea that is ``grotesque, at best.''
    This is an ethical principle that has united us in the 
past. The NIH guidelines forbid creation of embryos for this 
stem cell research.
    The Specter bill forbids this. And he recently said twice 
on the Charlie Rose Show that he continues to hold firmly 
against any special creation of embryos for research purposes.
    Even among those who support other forms of embryo 
research, this has been seen as a moral step too far to the 
totally utilitarian demoting of human life into a research 
entity.
    In short, I think we can support research and support 
useful medical progress, but also we should be serious. Do we 
want to ban human cloning?
    The Greenwood bill does not do it, and we believe the 
Weldon bill does, and does so in a way that is very carefully 
crafted and effective. Thank you.
    [The prepared statement of Richard M. Doerflinger follows:]
Prepared Statement of Richard M. Doerflinger on Behalf of the Committee 
    for Pro-Life Activities, National Conference of Catholic Bishops
    I am Richard M. Doerflinger, Associate Director for Policy 
Development at the Secretariat for Pro-Life Activities, National 
Conference of Catholic Bishops. I am grateful for this opportunity to 
testify on human cloning, and to express our Conference's support for a 
federal ban on the practice as proposed in Congressman Weldon's ``Human 
Cloning Prohibition Act of 2001'' (H.R. 1644).
    The sanctity and dignity of human life is a cornerstone of Catholic 
moral and social teaching. We believe a society can be judged by the 
respect it shows for human life, especially in its most vulnerable 
stages and conditions.
    At first glance, human cloning may not seem to threaten respect for 
life because it is presented as a means for creating life, not 
destroying it. Yet it shows disrespect for life in the very act of 
generating it. Here human life does not arise from an act of love, but 
is manufactured in the laboratory to preset specifications determined 
by the desires of others. Developing human beings are treated as 
objects, not as individuals with their own identity and rights. Because 
cloning completely divorces human reproduction from the context of a 
loving union between man and woman, such children have no ``parents'' 
in the usual sense. As a group of experts advising the Holy See has 
written:
        In the cloning process the basic relationships of the human 
        person are perverted: filiation, consanguinity, kinship, 
        parenthood. A woman can be the twin sister of her mother, lack 
        a biological father and be the daughter of her grandmother. In 
        vitro fertilization has already led to the confusion of 
        parentage, but cloning will mean the radical rupture of these 
        bonds.1
---------------------------------------------------------------------------
    \1\ Reflections from the Pontifical Academy for Life, ``Human 
Cloning Is Immoral'' (July 9, 1997), in The Pope Speaks, vol. 43, no. 1 
(January/February 1998), p. 29. Also see: Congregation for the Doctrine 
of the Faith, Donum Vitae (Instruction on Respect for Human Life in its 
Origin and on the Dignity of Procreation)(March 10, 1987), I.6 and 
II.B.
---------------------------------------------------------------------------
    From the dehumanizing nature of this technique flow many disturbing 
consequences. Because human clones would be produced by a means that 
involves no loving relationship, no personal investment or 
responsibility for a new life, but only laboratory technique, they 
would be uniquely at risk of being treated as ``second-class'' human 
beings.
    In the present state of science, attempts to produce a liveborn 
child by cloning would require taking a callous attitude toward human 
life. Animal trials show that 95 to 99% of cloned embryos die. Of those 
which survive, many are stillborn or die shortly after birth. The rest 
may face unpredictable but potentially devastating health problems. 
Those problems are not detectable before birth, because they do not 
come from genetic defects as such--they arise from the disorganized 
expression of genes, because cloning plays havoc with the usual process 
of genetic reorganization in the embryo.2
---------------------------------------------------------------------------
    \2\ See Testimony before the House Energy and Commerce Subcommittee 
on Oversight and Investigations, March 28, 2001, presented by Dr. Mark 
E. Westhusin and Dr. Rudolf Jaenishch (http://energycommerce.house.gov/
107/hearings/03282001Hearing141/hearing.htm).
---------------------------------------------------------------------------
    Scenarios often cited as justifications for human cloning are 
actually symptoms of the disordered view of human life that it reflects 
and promotes. It is said that cloning could be used to create 
``copies'' of illustrious people, or to replace a deceased loved one, 
or even to provide genetically matched tissues or organs for the person 
whose genetic material was used for the procedure. Each such proposal 
is indicative of a utilitarian view of human life, in which a fellow 
human is treated as a means to someone else's ends--instead of as a 
person with his or her own inherent dignity. This same attitude lies at 
the root of human slavery.
    Let me be perfectly clear. In objective reality a cloned human 
being would not be an ``object'' or a substandard human being. Whatever 
the circumstances of his or her origin, he or she would deserve to be 
treated as a human person with an individual identity. But the 
depersonalized technique of manufacture known as cloning disregards 
this dignity and sets the stage for further exploitation. Cloning is 
not wrong because cloned human beings would lack human dignity--it is 
wrong because they have human dignity, and are being brought into the 
world in a way that fails to respect that dignity.
    Ironically, startling evidence of the dehumanizing aspects of 
cloning is found in some proposals ostensibly aimed at preventing human 
cloning. These initiatives would not ban human cloning at all--but 
would simply ban any effort to allow cloned human embryos to survive. 
In these proposals, researchers are allowed to use cloning for the 
unlimited mass production of human embryos for experimentation--and are 
then required by law to destroy them, instead of allowing them to 
implant in a woman's womb.
    In other words: Faced with a 99% death rate from cloning, such 
proposals would ``solve'' the problem by ensuring that the death rate 
rises to 100%. No live clones, therefore no evidence that anyone 
performed cloning. This is reassuring for researchers and biotechnology 
companies who may wish the freedom to make countless identical human 
guinea pigs for lethal experiments. It is no great comfort to the dead 
human clones; nor is it a solution worthy of us as a nation.
    Congressman Greenwood's ``Cloning Prohibition Act of 2001'' (H.R. 
2172) is even worse than previous bills of this kind. It would actually 
have the Department of Health and Human Services authorize and license 
the practice of destructive cloning. In a new way, our government would 
be actively involved in human cloning--but only to ensure that no 
cloned embryos get out of the laboratory alive. Under the guise of a 
ban on cloning, the government would assist researchers in refining 
their procedure; then, ten years after the date of enactment, it would 
obligingly drop all penalties for using cloning to initiate a 
pregnancy, so they could use their newly honed skills to manufacture 
babies. This bill would even invalidate any future state law seeking to 
establish a genuine ban on cloning, by preempting any such law that 
does not take the same irresponsible approach.
    Sometimes it is said that such proposals would ban ``reproductive 
cloning'' or ``live birth cloning,'' while allowing ``therapeutic 
cloning'' or ``embryo cloning.'' This may sound superficially 
reasonable. If banning all cloning is too difficult a task, perhaps we 
could ban half of it--and the half that is ``therapeutic'' sounds like 
the half we'd like to keep.
    But this description relies on a fundamental confusion as to what 
cloning is. I can sum up the real situation in a few propositions.
    1. All human cloning is embryo cloning. Some accounts of cloning 
seem to imagine that cloning for research purposes produces an embryo, 
while cloning for reproductive purposes produces a baby or even a fully 
grown adult--like new copies of Michael Keaton or Arnold Schwarzenegger 
springing full-grown from a laboratory. This is, of course, nonsense. 
In the words of Professor Lee Silver of Princeton University, a leading 
advocate of human cloning: ``Real biological cloning can only take 
place at the level of the cell.'' 3
---------------------------------------------------------------------------
    \3\ Lee M. Silver, Remaking Eden: How Genetic Engineering and 
Cloning Will Transform the American Family (Avon Books 1998) at 124.
---------------------------------------------------------------------------
    Cloning technology can also be used to produce other kinds of 
cells; these are not the subject of this hearing, and they are 
explicitly excluded from the scope of Congressman Weldon's legislation. 
But when somatic cell nuclear transfer is used to replace the nucleus 
of an egg with the nucleus of a human body cell and the resulting cell 
is stimulated, a human embryo results, whatever one's ultimate plans on 
what to do next.4
---------------------------------------------------------------------------
    \4\ See the Fact Sheet, ``Does Human Cloning Produce an Embryo?'', 
Secretariat for Pro-Life Activities, National Conference of Catholic 
Bishops, March 31, 1998 (www.nccbuscc.org/prolife/issues/bioethic/
fact398.htm).
---------------------------------------------------------------------------
    2. In an important sense, all human cloning is reproductive 
cloning. Once one creates a live human embryo by cloning, one has 
engaged in reproduction--albeit a very strange form of asexual 
reproduction. All subsequent stages of development--gestation, birth, 
infancy, etc.--are simply those which normally occur in the development 
of any human being (though reaching them may be far more precarious for 
the cloned human, due to the damage inflicted by the cloning 
procedure).
    To say this is not to make a controversial moral claim about 
personhood or legal rights.5 It is to state a biological 
fact: Once one produces an embryo by cloning, a new living being has 
arrived and the key event in reproduction has taken place. The complete 
human genome that once belonged to one member of the human species now 
also belongs to another. Anything that now happens to this being will 
be ``environmental'' influence upon a being already in existence--
transfer to a womb and live birth, for example, are chiefly simple 
changes in location.
---------------------------------------------------------------------------
    \5\ Professor Silver, for example, agrees that cloning is 
accomplished at the embryonic level, while also claiming that the 
cloned embryo (and all other embryos) lack full moral significance 
until later in development. To his Princeton colleague Peter Singer and 
some other bioethicists, humans do not acquire the rights of persons 
until some time after birth. See P. Singer, ``Justifying Infanticide,'' 
in Writings on an Ethical Life (HarperCollins 2000), 186-193.
---------------------------------------------------------------------------
    Moreover, even government study commissions favoring harmful human 
embryo experiments concede that with the generation of a new embryo, a 
new life has come into the world. They describe the early embryo as ``a 
developing form of human life'' which ``warrants serious moral 
consideration.'' 6
---------------------------------------------------------------------------
    \6\ Final Report of the Human Embryo Research Panel (National 
Institutes of Health: September 27, 1994) at 2. The National Bioethics 
Advisory Commission, which defined the embryo as ``the beginning of any 
organism in the early stages of development,'' likewise said that ``the 
embryo merits respect as a form of human life'' (though not, the 
Commission thought, the level of respect owed to persons). See Ethical 
Issues in Human Stem Cell Research (National Bioethics Advisory 
Commission: September 1999) at 85, 50. Also see the sources cited in 
the Fact Sheet, ``What is an Embryo?'', Secretariat for Pro-Life 
Activities, National Conference of Catholic Bishops, Feb. 26, 1998 
(www.nccbuscc.org/prolife/issues/bioethic/fact298.htm).
---------------------------------------------------------------------------
    Thus generating this new human life in the laboratory confronts us 
with new moral questions: Not ``Should we clone?'' but ``What do we do 
with this living human we have produced by cloning?'' If all the 
available answers are lethal to the cloned human 95% to 100% of the 
time, we should not allow cloning.
    3. All human cloning, at present, is experimental cloning. The line 
between ``reproductive'' and ``experimental'' cloning is especially 
porous at present, because any attempt to move toward bringing a cloned 
child to live birth would first require many thousands of trials using 
embryos not intended for live birth. Years of destructive research of 
this kind may be necessary before anyone could bring a cloned human 
through the entire gestational process with any reasonable expectation 
of a healthy child. Therefore legislation which seeks to bar creation 
of a cloned embryo for purposes of live birth, while allowing unlimited 
experimental cloning, would actually facilitate efforts to refine the 
cloning procedure and prepare for the production of liveborn children. 
This would be irresponsible in light of the compelling principled 
objections to producing liveborn humans by cloning.
    4. No human cloning is ``therapeutic'' cloning. The attempt to 
label cloning for purposes of destructive experiments as ``therapeutic 
cloning'' is a stroke of marketing genius by supporters of human embryo 
research. But it does serious damage to the English language and common 
sense, for two reasons.
    First, the experiments contemplated here are universally called 
``nontherapeutic experimentation'' in law and medical ethics--that is, 
the experiments harm or kill the research subject (in this case the 
cloned human embryo) without any prospect of benefitting that subject. 
This standard meaning of ``nontherapeutic'' research is found, for 
example, in various state laws forbidding such research on human 
embryos as a crime.7 Experiments performed on one subject 
solely for possible benefit to others are never called ``therapeutic 
research'' in any other context, and there is no reason to change that 
in this context.
---------------------------------------------------------------------------
    \7\ For example, see La. Rev. Stat. tit. 14 Sec. 87.2 (a crime to 
conduct any experiment or study on a human embryo except to preserve 
the health of that embryo) and tit. 40 Sec. 1299.35.13 (prohibiting 
experimentation on an unborn child unless it is therapeutic to that 
child); Mich. Comp. Laws Sec. 333.2685 (prohibiting use of a live human 
embryo for nontherapeutic research that will harm the embryo); Pa. 
Cons. Stat. tit. 18 Sec. 3216(a) (nontherapeutic experimentation on an 
unborn child at any stage is a felony; defining ``nontherapeutic''); 
S.D. Codified Laws Sec. Sec. 34-14-16 through 34-14-20 (prohibiting 
nontherapeutic research that harms or destroys a human embryo; defining 
``nontherapeutic research'').
---------------------------------------------------------------------------
    Second, the ``therapeutic'' need for human cloning has always been 
highly speculative; it now seems more doubtful than ever in light of 
recent advances in adult stem cell research and other noncontroversial 
alternatives. In the stem cell research debate, as one recent news 
report observes, ``There is one thing everyone agrees on: Adult stem 
cells are proving to be far more versatile than originally thought.'' 
8 Adult stem cells have shown they can be ``pluripotent''--
producing a wide array of different cells and tissues.9 They 
can also be multiplied in culture to produce an ample supply of tissue 
for transplantation.10 Best of all, using a patient's own 
cells solves all problems of tissue rejection, the chief advantage 
cited until now for use of cloning.11
---------------------------------------------------------------------------
    \8\ A. Zitner, ``Diabetes Study Fuels Stem Cell Funding War,'' Los 
Angeles Times, April 27, 2001 (www.latimes.com/news/nation/updates2/
lat--stemwar010427.htm).
    \9\ Citing eleven other studies, a study funded by the National 
Institutes of Health (NIH) and the Christopher Reeve Paralysis 
Foundation states: ``Pluripotent stem cells have been detected in 
multiple tissues in the adult, participating in normal replacement and 
repair, while undergoing self-renewal.'' D. Woodbury et al., ``Adult 
Rat and Human Bone Marrow Stromal Cells Differentiate Into Neurons,'' 
61 Journal of Neuroscience Research 364-370 (August 15, 2000) at 364.
    \10\ See: D. Colter et al., ``Rapid expansion of recycling stem 
cells in cultures of plastic-adherent cells from human bone marrow,'' 
97 Proc. Natl. Acad. Sci. USA 3213-8 (March 28, 2000)(adult stem cells 
amplified a billion-fold in six weeks, retaining their 
multipotentiality for differentiation); E. Rosler et al., 
``Cocultivation of umbilical cord blood cells with endothelial cells 
leads to extensive amplification of competent CD34+CD38-cells,'' 28 
Exp. Hematol. 841-52 (July 2000).
    \11\ A recent report on use of adult stem cells to form new 
muscles, nerves, liver cells and blood vessels observes: ``None of 
these approaches use embryonic stem cells, which some oppose on ethical 
grounds. Another advantage is that they use tissue taken from the 
patient's own body, so there is no risk of rejection or need for drugs 
to suppress immune system defenses.'' See ``Approach may renew worn 
hearts,'' Associated Press, November 12, 2000.
---------------------------------------------------------------------------
    In 1997 the National Bioethics Advisory Commission reviewed the 
idea of cloning human embryos to create ``customized stem cell lines'' 
but described this as ``a rather expensive and far-fetched scenario''--
and added that a moral assessment is necessary as well:
        Because of ethical and moral concerns raised by the use of 
        embryos for research purposes it would be far more desirable to 
        explore the direct use of human cells of adult origin to 
        produce specialized cells or tissues for transplantation into 
        patients.12
---------------------------------------------------------------------------
    \12\ Cloning Human Beings: Report and Recommendations of the 
National Bioethics Advisory Commission (Rockville, MD: June 1997) at 
30-31. The Commission outlined three alternative avenues of stem cell 
research, two of which seemed not to involve creating human embryos at 
all.
---------------------------------------------------------------------------
    Now PPL Therapeutics, the Scottish firm involved in creating 
``Dolly'' the sheep, says it has indeed found a way to reprogram 
ordinary adult cells to become stem cells capable of being directed to 
form almost any kind of cell or tissue--without creating or destroying 
any embryos.13
---------------------------------------------------------------------------
    \13\ ``PPL follows Dolly with cell breakthrough,'' Financial Times, 
February 23, 2001.
---------------------------------------------------------------------------
    Even in the field of embryonic stem cell research, new developments 
have called into question the need for cloning. The problem of tissue 
rejection may not be as serious as once thought when cells from early 
human development are used, and there are other ways of solving the 
problem--for example, by genetically modifying cells to become a closer 
match to a patient.14
---------------------------------------------------------------------------
    \14\ P. Aldhous, ``Can they rebuild us?'', 410 Nature 622-5 (5 
April 2001) at 623.
---------------------------------------------------------------------------
    For all these reasons, a recent overview of the field concludes 
that human ``therapeutic cloning'' is ``falling from favour,'' that 
``many experts do not now expect therapeutic cloning to have a large 
clinical impact.'' Even James Thomson of the University of Wisconsin, a 
leading practitioner and advocate of embryonic stem cell research 
generally, calls this approach ``astronomically expensive''; in light 
of the enormous wastefulness of the cloning process and the damage it 
does to gene expression, ``many researchers have come to doubt whether 
therapeutic cloning will ever be efficient enough to be commercially 
viable'' even if one could set aside the grave moral issues 
involved.15
---------------------------------------------------------------------------
    \15\ Id. at 622.
---------------------------------------------------------------------------
    We should clearly understand what would be entailed by any effort 
to implement a ``therapeutic cloning'' regimen for stem cell 
transplants. This would not be a case in which human embryos are 
destroyed once to form a permanent cell line for future use. For each 
individual patient, countless human embryos--the patient's genetic twin 
brothers or sisters--would have to be created in the laboratory and 
then destroyed for their stem cells, in the hope of producing 
genetically matched tissue for transplantation. Thus the creation and 
destruction of human life in the laboratory would become an ongoing 
aspect not only of medical research but of everyday medical practice. 
And what would become of those who have profound moral objections to 
cloning, and to having new lives created and destroyed for our benefit? 
Would we be told that we must choose between our life and our 
conscience?
    In short, the ``therapeutic'' case for cloning is as morally 
abhorrent as it is medically questionable. Which brings me to a final 
proposition on how to assess proposals for preventing human cloning.
    5. Because cloned humans are humans, any proposal to prevent human 
cloning must not do to cloned humans anything that would be universally 
condemned if done to other humans at the same stage of development.
    This proposition can be universally endorsed by people on both 
sides of the cloning issue, and on both sides of the abortion issue. To 
quote Lee Silver once more: ``Cloned children will be full-fledged 
human beings, indistinguishable in biological terms from all other 
members of the human species.'' 16 Thus, for example, cloned 
embryos deserve as much respect as other human embryos of the same 
stage--whatever that level of respect may be.
---------------------------------------------------------------------------
    \16\ Silver at 125.
---------------------------------------------------------------------------
    Silver's point about cloned humans being ``indistinguishable'' from 
others raises a major practical problem for efforts to allow creation 
of cloned embryos while forbidding their transfer to a womb. Once the 
embryo is created in a fertility clinic's research lab (as such a law 
would permit) and is available for transfer, how could the government 
tell that this embryo was or was not created by cloning? And if it 
cannot do so, how can it enforce a prohibition on transferring cloned 
embryos (but not IVF embryos) to a woman's womb?
    However, an even more serious moral and legal issue arises at this 
point. If the government allows use of cloning to produce human embryos 
for research but prohibits initiating a pregnancy, what will it be 
requiring people to do? If pregnancy has already begun, the only remedy 
would seem to be government-mandated abortion--or at least, jailing or 
otherwise punishing women for remaining pregnant and giving birth. We 
need not dwell on the abhorrence such a solution would rightly provoke 
among people on all sides of the abortion issue. It would be as ``anti-
choice'' as it is ``anti-life.''
    However, even if the law could act before transfer actually occurs, 
the problem is equally intractable. For the law would have to require 
that these embryos be killed--defining for the first time in U.S. 
history a class of human embryos that it is a crime not to destroy. It 
is impossible to reconcile such a law with the profound ``respect'' and 
``serious moral consideration'' that even supporters of human embryo 
research say should be accorded to all human embryos.
    If the law permitted (or, even worse, licensed) creation of cloned 
embryos for research, while prohibiting their creation for any other 
purpose (or prohibiting any other use of them once created), the 
government would be approving the one practice in human embryo research 
that is widely condemned even by supporters of abortion rights: 
specially creating human embryos solely for the purpose of research 
that will kill them.
    In 1994 the National Institutes of Health did propose funding such 
abuses, as part of a larger proposal for funding human embryo research 
generally. The moral outcry against this aspect of the proposal, 
however, was almost universal. Opinion polls showed massive opposition, 
and the NIH panel making the recommendation was inundated with over 
50,000 letters of protest. The Washington Post, while reaffirming its 
support for legalized abortion, attacked the Panel's recommendation:
        The creation of human embryos specifically for research that 
        will destroy them is unconscionable . . . [I]t is not necessary 
        to be against abortion rights, or to believe human life 
        literally begins at conception, to be deeply alarmed by the 
        notion of scientists' purposely causing conceptions in a 
        context entirely divorced from even the potential of 
        reproduction.17
---------------------------------------------------------------------------
    \17\ Editorial, ``Embryos: Drawing the Line,'' The Washington Post, 
October 2, 1994 at C6.
---------------------------------------------------------------------------
The Chicago Sun-Times likewise editorialized:
        We can debate all day whether an embryo is or isn't a person. 
        But it is unquestionably human life, complete with its own 
        unique set of human genes that inform and drive its own 
        development. The idea of the manufacture of such a magnificent 
        thing as a human life purely for the purpose of conducting 
        research is grotesque, at best. Whether or not it is federally 
        funded.18
---------------------------------------------------------------------------
    \18\ Editorial, ``Embryo Research Is Inhuman,'' Chicago Sun-Times, 
October 10, 1994 at 25.
---------------------------------------------------------------------------
In the end, President Clinton set aside the recommendation for creation 
of ``research embryos.''
    Every year since then, Congress has prohibited funding for all 
harmful embryo research at the National Institutes of Health, through 
the Dickey amendment to the annual Labor/HHS appropriations 
bills.19 However, even members of Congress who have led the 
opposition to the Dickey amendment agree with its rejection of special 
creation of human embryos for research. On the only occasion when an 
amendment was offered on the House floor to weaken the Dickey 
amendment, the sponsors emphasized that it would leave intact the 
clause rejecting the creation of embryos for research.20 
Similarly, the recent NIH guidelines for embryonic stem cell research, 
as well as Senator Specter's ``Stem Cell Research Act of 2001,'' 
explicitly reject the idea of using embryos specially created for 
research purposes.21
---------------------------------------------------------------------------
    \19\ The current version is Section 510 of the Labor/HHS 
appropriations bill for Fiscal Year 2001, H.R. 5656 (enacted through 
Section 1(a)(1) of H.R. 4577, the FY '01 Consolidated Appropriations 
Act, Public Law 106-554). It bans funding any creation of human embryos 
(by cloning or other means) for research purposes, and any research in 
which human embryos are harmed or destroyed.
    \20\ ``Let me say that I agree with our colleagues who say that we 
should not be involved in the creation of embryos for research. I 
completely agree with my colleagues on that score,'' said Rep. Nancy 
Pelosi, arguing in favor of research on ``spare'' embryos originally 
created for fertility treatment. The sponsor of the weakening 
amendment, Rep. Nita Lowey, said: ``I want to make it very clear: We 
are not talking about creating embryos . . . President Clinton again 
has made it very clear that early-stage embryo research may be 
permitted but that the use of Federal funds to create embryos solely 
for research purposes would be prohibited. We can all be assured that 
the research at the National Institutes of Health will be conducted 
with the highest level of integrity. No embryos will be created for 
research purposes . . .'' 142 Cong. Record at H7343 (July 11, 
1996)(emphasis added). The weakening amendment failed nonetheless, 167 
to 256. Id. at H7364. While this debate concerned federal funding, 
supporters of the Lowey amendment said it was ``very hard to 
understand'' why standards for ethical research should be different for 
publicly funded and privately funded research. See remarks of Rep. 
Fazio at H7341-2.
    \21\ The NIH guidelines deny funding for ``research utilizing 
pluripotent stem cells that were derived from human embryos created for 
research purposes,'' and ``research in which human pluripotent stem 
cells are derived using somatic cell nuclear transfer, i.e., the 
transfer of a human somatic cell nucleus into a human or animal egg.'' 
National Institutes of Health Guidelines for Research Using Human 
Pluripotent Stem Cells, 65 Fed. Reg. 51976-81 (August 25, 2000) at 
51981. Senator Specter's bill supports embryonic stem cell research but 
insists that ``the research involved shall not result in the creation 
of human embryos.'' 107th Congress, S. 723, Sec. 2.
---------------------------------------------------------------------------
    As mentioned above, at least nine states generally prohibit harmful 
experiments on human embryos living outside a woman's body. A federal 
law that facilitates such experimentation, by approving it as the only 
accepted use for human embryo cloning, would mark a radical departure 
from state precedents on respect for nascent human life.22 
In short, human embryos produced by cloning would be created 
specifically, and solely, for destructive embryo experiments that are a 
crime in some states.
---------------------------------------------------------------------------
    \22\ In Louisiana, for example, a human embryo fertilized in the 
laboratory may generally be used only for efforts at a live birth, not 
for research. La. Rev. Stat. tit. 9 Sec. 122. What would happen if a 
new federal law turned this on its head, and banned creating embryos 
for live birth while allowing their creation for destructive research--
keeping in mind that cloned embryos may be biologically 
indistinguishable from IVF embryos once created?
---------------------------------------------------------------------------
    Ironically, it seems the cloning procedure is so demeaning and 
dehumanizing that people somehow assume that a brief life as an object 
of research, followed by destruction, is ``good enough'' for any human 
produced by this technique. The fact that the procedure invites such 
morally irresponsible policies is another reason to ban it. For if an 
embryo produced by cloning cannot even garner the respect that we all 
agree should be accorded to all other human embryos, but is treated as 
a dangerous entity that must not be allowed to survive, how will we 
view any human clone who is ultimately born alive? As a mere ``organ 
farm'' for others? Or could we compartmentalize our thinking, so that 
an embryo created solely for destructive research will be greeted as a 
new individual with full human rights if someone does bring him or her 
to full term? In light of some uses proposed even now for born human 
clones, it would be foolish to assume that our society will shift gears 
so easily.
    We must remember that it is morally wrong and irresponsible to make 
human clones, not to be a human clone. The innocent victim of cloning 
should not receive a government-sanctioned death penalty simply for the 
crime of existing. Therefore the approach taken by the Weldon bill, 
prohibiting the use of cloning to initiate the development of a new 
human organism, is the only morally responsible approach as well as the 
clearest and most effective one in practical terms.
    The Weldon bill even incorporates key distinctions and 
recommendations made by the Biotechnology Industry Organization (BIO) 
and its leading spokesperson on cloning. It bans the specific act of 
using cloning to make a new human organism, but does not ban 
``therapeutic cloning'' as defined in Dr. Okarma's recent House 
testimony on behalf of BIO: ``cloning specific human cells, genes and 
other tissues that do not and cannot lead to a cloned human being.'' 
23 This bill clearly exempts from its scope the use of 
cloning to make any cells other than human embryos. And the Weldon 
bill's distinction between human embryos, which are complete human 
organisms, and other cells such as pluripotent stem cells, which are 
not, was strongly affirmed by BIO's chief spokesperson on cloning in 
December 1998 as a basis for federal policy on embryo 
research.24
---------------------------------------------------------------------------
    \23\ Testimony of Dr. Thomas Okarma on behalf of the Biotechnology 
Industry Organization (BIO) before the House Energy and Commerce 
Subcommittee on Oversight and Investigations, March 28, 2001.
    \24\ In his December 2, 1998 testimony before the Senate 
Appropriations Subcommittee on Labor, Health and Human Services and 
Education, Dr. Okarma joined other scientists and ethicists in agreeing 
that a stem cell is not a human ``organism'' as a human embryo is, and 
therefore is not covered by the statutory ban on federal funding for 
human embryo research. HHS General Counsel Harriet Rabb also relied 
heavily on this distinction (and this testimony) in finding that the 
federal government may fund embryonic stem cell research. If this 
distinction between human embryos and all other cells were problematic, 
unclear or unenforceable, the current NIH guidelines for stem cell 
research would clearly be illegal. (As I pointed out to the same Senate 
subcommittee in my January 26, 1999 testimony, the NIH guidelines are 
in fact illegal but on other grounds. See www.nccbuscc.org/prolife/
issues/bioethic/test99.htm.)
---------------------------------------------------------------------------
    By contrast, the Greenwood bill is not only morally unacceptable 
because of the encouragement it gives to experimental human cloning--it 
also contains features which BIO has said are unacceptable in any 
cloning ban. For example, instead of prohibiting the specific act of 
cloning a human being, it relies heavily on the ``intent'' of 
researchers in an attempt to define good and bad uses for human 
cloning. BIO has declared that such a subjective standard ``could grant 
undue discretion to enforcers, create uncertainty for researchers, and 
consequently have a broad chilling effect among researchers.'' 
25 Moreover, unlike the Weldon bill, the Greenwood proposal 
has a forfeiture clause calling for the confiscation of all a 
violator's assets, which BIO has said will have ``a definite chilling 
effect of investor interest in funding research.'' 26
---------------------------------------------------------------------------
    \25\ Actually the bill's ``intent'' standard makes its 
enforceability doubtful. A researcher's ``intent'' for future use of a 
cloned embryo is inherently changeable and unknowable, so it will be 
extremely difficult to prove until he or she acts on that intent by 
using the embryo to initiate a pregnancy--at which point it is too late 
for any morally defensible or constitutionally sound way to prevent the 
birth of cloned humans. If BIO's charges about a chilling effect on 
legitimate research are also correct, the Greenwood bill will be an 
unusual achievement--a bill that would never lead to a conviction 
against its supposed targets, but in the meantime would harass and 
frighten those who conduct research the bill ostensibly seeks to 
protect.
    \26\ See BIO's criteria for cloning legislation, posted on the 
organization's Web site at www.bio.org/laws/cloning__paper2.html.
---------------------------------------------------------------------------
    Contrary to what the biotechnology industry may now claim in a 
clumsy attempt to block any real ban on cloning, then, BIO's own 
standards suggest that the Greenwood bill is a far greater threat to 
legitimate medical research than the Weldon bill could be. In addition, 
the Greenwood bill is singularly ineffectual at doing what it was 
supposedly designed to do--that is, preventing the live birth of human 
clones. While it seeks to ban the creation of cloned embryos with the 
``intent'' to initiate a pregnancy, it freely allows the unlimited 
creation of these embryos in the laboratory--and then freely allows 
anyone (except the person who first created them) to use them to 
initiate a pregnancy, since the act of doing so is not itself 
prohibited. The only way to prevent the live birth of cloned humans 
once this is allowed to occur, of course, would be the odious and 
unacceptable solution of coercing an abortion.
    In any event, the Greenwood bill's ``rule of construction'' 
vitiates any ban in two ways. First, it exempts from the ban any use of 
cloning to create ``cells'' regardless of one's further intent on how 
to use them--and a new human embryo is, of course, a cell of a very 
special type. Second, it exempts ``[t]he use of in vitro fertilization, 
the administration of fertility-enhancing drugs, or the use of other 
medical procedures to assist a woman in becoming or remaining 
pregnant''--and of course, the transfer of an embryo (whether produced 
by cloning or not) to a woman's womb is a medical procedure which could 
assist her in becoming pregnant.
    This is a cloning ban that only a supporter of cloning could 
love.27 It combines the moral defect of establishing a 
regimen for the government-mandated destruction of human lives, and the 
practical defect of massive loopholes that will ensure the arrival of 
live-birth cloning as well.
---------------------------------------------------------------------------
    \27\ Indeed BIO, which now supports the Greenwood bill, previously 
announced on several occasions that it favors no new legislation 
against human cloning. BIO recommended to the National Bioethics 
Advisory Commission that a ``voluntary moratorium'' on cloning (which 
is to say, no moratorium at all) be continued ``in lieu of any new 
federal law or regulation regarding the cloning of an entire human 
being.'' See www.bio.org/bioethics/nbac.html. In its recent March 28 
testimony BIO reaffirmed its opposition to any new federal ban on human 
cloning. The Greenwood bill is exempt from this policy because it is no 
ban at all. It would even preempt and thus invalidate any effective 
future ban a state may enact, creating a situation better for the most 
irresponsible researchers (and far
---------------------------------------------------------------------------
    In short: Some would reject the most straightforward and effective 
legislation against human cloning, solely to protect the use of cloning 
for a practice (creating human embryos solely for research) which is of 
highly questionable use and has been rejected by policy makers on both 
sides of the abortion and stem cell debates. Such advocacy should not 
prevent Congress from taking the right course on this issue.
    Research in the cloning of animals, plants, and even human genes, 
tissues and cells (other than embryos) can be beneficial and presents 
no intrinsic moral problem. However, when research turns its attention 
to human subjects, we must be sure not to undermine human dignity in 
the pursuit of human progress. Human experimentation divorced from 
moral considerations might progress more quickly on a technical level--
but at the loss of our humanity.
    A ban on human cloning will help direct the scientific enterprise 
toward research that benefits human beings without producing, 
exploiting and destroying fellow human beings to gain those benefits. 
Creating human life solely to cannibalize and destroy it is the most 
unconscionable use of human cloning--not its highest justification.

    Mr. Bilirakis. Thank you very much, Mr. Doerflinger.
    Mr. Fukuyama?

                  STATEMENT OF FRANCIS FUKUYAMA

    Mr. Fukuyama. Thank you, Mr. Chairman, for the opportunity 
to testify before this subcommittee on the subject of human 
cloning. I am Dr. Francis Fukuyama. For another 10 days, I will 
be a professor at George Mason University, at which point I 
become Bernard Schwartz Professor of International Political 
Economy at the Paul H. Nitze School of Advanced International 
Studies, John Hopkins University.
    And I have been working very intensively over the past few 
years on the implications of modern biology for politics, and 
particularly for issues--on issues of international governance 
related to biotechnology.
    Now, one advantage of being the last speaker is that I have 
found that most of my points have already been made by other 
panelists, so I skip over a number of sections.
    I am opposed to cloning for the reasons I think that have 
been, particularly by Dr. Kass, articulated, by other speakers 
as well articulated, very well. And I think that it is 
extremely important, in light of the consensus on reproductive 
cloning that is evident in this room, that the Congress act 
quickly on this to establish the principle that it is not 
scientists who are sovereign, but the political community, the 
Democratic political community as such, that is sovereign and 
has the power to control the pace and scope of such 
technological developments.
    There is another reason I think for Congress to act 
quickly, which is related to our American political system. In 
the past, it has been the case that the Courts have stepped 
into controversial areas of social policy when the Legislature 
has failed to negotiate acceptable political rules. This was 
the case in abortion and bussing, among other things.
    In the absence of Congressional action on cloning, it is 
conceivable that the Courts, at some later point, may be 
tempted or compelled to step into the breach and discover, for 
example, that human cloning, or research on cloning, is a 
Constitutionally protected right.
    I think this would be an absurd outcome. It would certainly 
be a very poor approach to the formulation of law and public 
policy.
    So, the American people, therefore, need to express their 
will on human cloning at the first opportunity through their 
democratically elected representatives.
    Of the two bills, H.R. 1644 and H.R. 2172, I support the 
former, the Weldon bill again, primarily because of the non--
what I regard as the non-enforceability of the ban on 
reproductive cloning, which has, again, been articulated by 
earlier speakers.
    I would make one further point. I believe that creation of 
embryos for research purposes, in itself, is morally 
questionable. I am fairly agnostic on the question of abortion. 
But it does seem to me that there is an intermediate position.
    You do not have to believe that a one-cell embryo is a 
human being, a full human being, to believe also that it is not 
just another cell, because it has the potential to develop into 
a full human being.
    One of the earlier speakers said that Kant would have said, 
well, the rule about treating people as ends, not as means 
applies only to rational human beings. If that were the case, 
you could experiment on infants because I have never met an 
infant that was particularly rational in my conversation with 
them.
    The issue I would like to raise before this committee 
concerns the international dimensions of any effort to regulate 
a medical technology like human cloning. Opponents of a 
legislative ban frequently argue that such a ban would be 
rendered ineffective by the fact that we live in a globalized 
world, and any attempt to regulate a medical technology by 
sovereign nation states can easily be side-stepped by moving 
the research to another jurisdiction.
    There are other advanced countries in Europe and Asia that 
are eager to move ahead in biotechnology, it is said, and the 
U.S. will risk falling behind technologically if we hobble 
ourselves by restricting either research into or the actual 
practice of cloning.
    In the absence of comprehensive international regulation, 
no national regulation will work. This is part of a widespread, 
larger belief that technological advance should not and cannot 
be stopped.
    I believe that this line of reasoning is fundamentally 
flawed. In the first place, it is simply not the case that the 
pace and scope of technological advance cannot be controlled 
politically.
    There are many dangerous and controversial technologies, 
including nuclear weapons and nuclear power, ballistic 
missiles, biological and chemical warfare agents, replacement 
of human body parts, neuropharmacological drugs, and, indeed, 
genetically engineered crops and the like, which cannot be 
freely developed or traded internationally.
    We have successfully regulated experimentation in human 
subjects internationally for many decades. And the fact that 
none of these regulator regimes has ever been leak-proof or the 
regulations fully implemented is not an excuse for not trying 
to put them in place in the first instance.
    And second, I think that to argue that any national ban or 
regulation cannot precede an international agreement on the 
subject is to put the cart before the horse. Regulation never 
starts at an international level.
    Nation states have to set up enforceable rules for their 
own societies before they can even think about international 
ones.
    The United States is economically, politically, and 
culturally a dominant force in the world and will have an 
enormous impact on other societies.
    Council on Europe has already passed a ban on cloning. To 
date, 24 countries have enacted national bans on cloning. And 
in regard to the difference between the two bills, I should 
point out although it is mentioned that England has passed a 
very permissive legislation on research cloning, that France, 
Germany, Austria, Switzerland, Norway, Brazil and Peru have 
already passed explicit legislation prohibiting it.
    And laws in Ireland, Hungary, Poland, Costa Rica and 
Ecuador implicitly ban this procedure. So, there is an open 
question whether England will be an outlier in this regard, or 
whether it is the tip of an iceberg. It is hard to predict that 
in advance, but we can't know that unless we try to do the 
legislation.
    I finally believe that international competition in 
biomedical research is an important problem. But we cannot 
answer it by simply agreeing to join in a technological arms 
race.
    My final point is that human cloning is the first of many 
political decisions and battles that will occur over 
biotechnology. I think in the future total bans on research and 
technology development of the sort envisioned by H.R. 1644 will 
not be the right model.
    We will soon need a regulatory structure that will permit 
us, on a routine basis, to make decisions that distinguish 
between technologies that we regard as positive, and helpful 
advances for human wellbeing, and those that raise troubling 
moral and political questions.
    However, that is not the case with the issue of human 
cloning where there is a large consensus that it is not 
acceptable and very few interests in its favor. Thank you very 
much for your attention.
    [The prepared statement of Francis Fukuyama follows:]

    Prepared Statement of Francis Fukuyama, Omer L. and Nancy Hirst 
          Professor of Public Policy, George Mason University

    Thank you, Mr. Chairman, for the opportunity to testify before this 
subcommittee on the subject of human cloning. I am Dr. Francis 
Fukuyama, and as of July 1 of this year I will be Bernard Schwartz 
Professor of International Political Economy at the Paul H. Nitze 
School of Advanced International Studies, Johns Hopkins University. I 
have been working intensively for the past several years on the 
implications of modern biology for politics, and particularly on issues 
of international governance related to biotechnology.
    I am opposed to human cloning for two reasons. The first is that 
human reproductive cloning, if and when it becomes possible, will 
constitute a highly unnatural form of reproduction, one that interferes 
with the normal process of conception and establishes a very abnormal 
relationship between parent and child. I believe that human nature is a 
valid standard for establishing human rights, and that technological 
procedures that interfere egregiously with normal human functioning 
should be viewed very skeptically in the absence of very powerful 
reasons to do so. I do not have time today to defend this position at 
greater length, but would be happy to provide the subcommittee with 
further materials at a later time.
    The second reason that I am opposed to human cloning, and in 
support of legislation to curtail it, is that cloning represents the 
opening wedge for a series of future technologies that will permit us 
to alter the human germline and ultimately to design people 
genetically. I believe that we must proceed extremely cautiously in 
this direction because such a capability of altering human nature has 
extremely grave political, social, and moral implications. It is 
therefore extremely important that Congress act legislatively at this 
point to establish the principle that our democratic political 
community is sovereign and has the power to control the pace and scope 
of such technological developments.
    There is another reason for Congress to act quickly, one that is 
related to our American political system. In the past, it has been the 
case that the courts have stepped into controversial areas of social 
policy when the legislature failed to act to negotiate acceptable 
political rules. This was the case, for example, with both abortion and 
busing. In the absence of Congressional action on cloning, it is 
conceivable that the courts at some later point may be tempted or 
compelled to step into the breech and discover, for example, that human 
cloning or research on cloning is a constitutionally protected right. 
This has been and will be a very poor approach to the formulation of 
law and public policy. The American people must therefore express their 
will on human cloning at the first opportunity through their 
democratically elected representatives, a will that I believe the 
courts will be predisposed to respect.
    Of the two bills before this committee, H.R. 1644, ``The Human 
Cloning Prohibition Act of 2001,'' and H.R. 2172, ``The Cloning 
Prohibition Act of 2001,'' I would strongly urge Congress to pass the 
former. The reason for this is that while both bills ban reproductive 
cloning, the latter in effect legalizes non-reproductive cloning and 
the deliberate creation of embryos for research purposes. I believe 
that this would legitimate the first step toward the manufacture of 
human beings, and I do not believe that it will be possible to enforce 
a ban on reproductive cloning once embryos can be easily produced for 
research purposes.
    The issue that I would like to raise before this committee concerns 
the international dimensions of any effort to regulate a medical 
technology like human cloning. Opponents of a legislative ban 
frequently argue that such a ban would be rendered ineffective by the 
fact that we live in a globalized world in which any attempt to 
regulate technology by sovereign nation-states can easily be 
sidestepped by moving to another jurisdiction. There are other advanced 
countries in Europe and Asia eager to move ahead in biotechnology, it 
is said, and the United States will risk falling behind technologically 
if we hobble ourselves by restricting either research into or the 
actual procedure of cloning. In the absence of comprehensive 
international regulation, no national regulation will work. This is 
part of a larger widespread belief that technological advance should 
not and cannot be stopped.
    I believe that this is a fundamentally flawed argument. In the 
first place, it is simply not the case that the pace and scope of 
technological advance cannot be controlled politically. There are many 
dangerous or controversial technologies, including nuclear weapons and 
nuclear power, ballistic missiles, biological and chemical warfare 
agents, replacement human body parts, neuropharmacological drugs, and 
the like which cannot be freely developed or traded internationally. We 
have successfully regulated experimentation in human subjects 
internationally for many decades. The fact that none of the regulatory 
regimes controlling these technologies has ever been leakproof or 
regulations fully implemented has never been a valid reason not to try 
to put them in place in the first instance.
    Second, to argue that no national ban or regulation can precede an 
international agreement on the subject is to put the cart before the 
horse. Regulation never starts at an international level: nation-states 
have to set up enforceable rules for their own societies before they 
can even begin to think about international rules. The United States, 
as an economically, politically, and culturally dominant force in the 
world will have an enormous impact on other societies. The Council on 
Europe has already passed a ban on cloning; to date, twenty-four 
countries (including Germany, France, Italy, and Japan) have already 
enacted national bans on cloning, while sixteen have banned creation of 
embryos for research purposes. The United States can do a great deal to 
either reinforce (or else undermine) an emerging international 
consensus that human cloning is an unacceptable use of medical 
technology.
    I do believe that international competition in biomedical research 
creates problems for any nation that wants to limit or control new 
technology. There are a number of countries that will try to exploit a 
human cloning ban or any other constraints the United States places on 
the development of future biotechnologies. We should not be prematurely 
defeatist, however, in thinking that we have no choice but to join in 
this technological arms race. If we can establish a general consensus 
among civilized nations that human cloning is unacceptable, we will 
then have a range of traditional diplomatic and economic instruments at 
our disposal to persuade or pressure countries outside that consensus 
to join. If human cloning ends up being a procedure that can be 
performed, but only in states regarded as renegade or pariahs, then so 
much the better. But none of this will be possible unless we first 
begin by establishing laws on this subject for the United States.
    Let me close by saying that human cloning is the first of many 
political decisions and battles that will occur over biotechnology. In 
the future, total bans on research and technology development of the 
sort envisioned by H. R. 1644 will not be the right model. What we will 
soon need is a broader regulatory structure that will permit us, on a 
routine basis, to make decisions that distinguish between those 
technologies that represent positive and helpful advances for human 
well-being, and those that raise troubling moral and political 
questions. Ultimately, this regulation will have to become 
international in scope if it is to be more effective. We will need to 
think carefully about the institutional form that such a regulatory 
structure must take. A blanket ban on human cloning is appropriate at 
this time, however, because it is necessary at an early point to 
establish the principle that the political community has the 
legitimacy, authority, and power to control the direction of future 
biomedical research, on an issue where it is difficult to come up with 
compelling arguments about why there is a legitimate need for human 
cloning.
    Thank you very much for your attention.

    Mr. Bilirakis. Thank you, Mr. Fukuyama.
    Well, are we all agreed that the Weldon bill, the former of 
the two bills as it has been referred to here, does not ban or 
preclude the cloning of human tissue that does not give rise to 
an embryo? We are all agreed there, Mr. Okarma? We are agreed? 
Because you made comments about the Weldon bill would----
    Mr. Okarma. (No audible response, nodded.)
    Mr. Bilirakis. Okay. Dr. Newman, can we take stem cells 
from our own bodies to be used for an affliction in another 
part of our body, bone marrow I suppose?
    Mr. Newman. Well, these are called adult stem cells.
    Mr. Bilirakis. Yeah.
    Mr. Newman. And adult stem cells can be taken from the bone 
marrow, from fat, from muscle, from the brains of recently 
deceased people. And----
    Mr. Bilirakis. Can take it from my body, for instance, 
for--to help an affliction that I have?
    Mr. Newman. Yes, you could take your own bone marrow----
    Mr. Bilirakis. Right.
    Mr. Newman. [continuing] and stem cells can be isolated 
from your own bone marrow, from your own fat tissue, yes.
    Mr. Bilirakis. Thank you, sir. You referred to the ultimate 
adult stem cell, which appears to have been discovered in the 
bone marrow that can transform itself into almost any organ in 
the body. And this is according to the study published in the 
May 4 issue of New York University School of Medicine. You 
mention Yale University School of Medicine----
    Mr. Newman. The publication of Cell.
    Mr. Bilirakis. Issue of Cell by New York, published in an 
issue of Cell by NYU School of Medicine, Yale University School 
of Medicine, and Johns Hopkins School of Medicine and 
Researchers.
    There is a comment made by Dr. Tice, ``There is a cell in 
the bone marrow that can serve as the stem cell for most, if 
not all, of the organs in the body.'' And then, ``This is an 
exciting study,'' etcetera, etcetera. I know at the University 
of Florida, one of my alma maters, they have announced that 
they have reversed diabetes in mice using adult stem cells.
    I might add that to--for the benefit of Ms. DeGette, that 
JDF was invited to come here to testify, and they for some 
reason or other----
    Ms. DeGette. If the gentleman would----
    Mr. Bilirakis. [continuing] were not able to do so----
    Ms. DeGette. [continuing] yield.
    Mr. Bilirakis. [continuing] which is unfortunate.
    Ms. DeGette. Mr. Chairman, if the gentleman would yield one 
moment? The Juvenile Diabetes Foundation would have liked to 
have testified. This weekend is their big Children's Congress.
    Mr. Bilirakis. I see.
    Ms. DeGette. They are bringing children from all around the 
country to lobby Congress on Type-1 diabetes. So, I am sorry 
they couldn't come.
    Mr. Bilirakis. Okay. No, and I appreciate that explanation 
because they are really one of my favorite groups. I feel very 
strongly about them, and I am glad to hear that explanation.
    In any case, there has been some research done in that 
regard. And we also know that Americans presently destroy some 
4 million placentas and umbilical cords every year, which could 
be an abundant supply of stem cells.
    I guess I raise the question, there is this controversial 
issue of the use of the embryo. If we can help the people who 
need help--and we have all had members of families--I lost my 
youngest brother to Parkinson's.
    If we can help the people that need to be helped through 
the adult stem cells which appear to have been discovered 
through the use of placentas and umbilical cords, which are 
just thrown away, why is it that we have got to insist on 
this--this controversial, very controversial, area of using an 
embryo, cloning an embryo, and using that?
    Does that make too sense, Mr. Doerflinger?
    Mr. Doerflinger. Well, obviously, Mr. Chairman, I would ask 
that question too. I wanted to respond to what Ms. DeGette said 
about--about diabetes research. I think the Canadian trial----
    Mr. Bilirakis. Do it real quickly, but I would like to have 
a response----
    Mr. Doerflinger. Yes.
    Mr. Bilirakis. [continuing] a few responses to my question.
    Mr. Doerflinger. Yes, I think--absolutely. President 
Clinton's National BioEthics Advisory Commission said that it 
would be ethically unjustified even to use spare embryos from 
IVF clinics if there are less morally controversial 
alternatives available. And I think it has been proved again, 
and again, and again those alternatives are there.
    The Canadian study, I think we are talking about the 
University of Ottawa trials? Yes. Those were adult islet cell 
transplants. Those had nothing to do with embryonic stem cells. 
They were taken from cadavers.
    And the reason why these trials worked and had several 
patients walking around without any further need for insulin 
injections were two advances in the transplant technique.
    One was that they used two cadavers for each transplant 
instead of one to get a bigger volume of the islet cells, and 
the other was a new immuno-suppressive drug that greatly 
reduced the tissue rejection problem, the very problem that we 
are now being told human cloning is essential for. And that is 
just not true.
    Mr. Bilirakis. Any other comments? Dr. Newman? ---- 1 Mr. 
Newman. These problems of tissue repair, the repair of the 
heart wall after a mild cardio infarction, the repair of 
damaged skin and so---- all of these can be addressed by cells 
that have the potential to repair those tissues.
    A study that I briefly alluded to, but it was published 
recently in Nature by some colleagues of mine at New York 
Medical College and at the NIH, took bone marrow cells from the 
mouse and isolated adult stem cells from those bone marrows, 
and implanted them into the heart walls of mice whose hearts 
had been damaged by a heart attack, an induced heart attack.
    And those bone marrow stem cells were able to repair the 
damage in the wall of those damaged hearts. So, it seems to me 
that there is a tremendous amount of promise in therapeutics 
using adult stem cells.
    I don't--I mean, as I said, the Council for Responsible 
Genetics isn't, in principle, against using embryo stem cells 
from non-cloned embryos. But I see much more promise in the 
adult stem cells, actually.
    Mr. Bilirakis. How close are we to their being available in 
a way that we would be confident that they would be helpful?
    Mr. Newman. Well, adult stem cells are already available. I 
guess approval needs to be done based on good animal 
experiments, which are coming out now. But I think it is just a 
regulatory issue now because I think that there are adult stem 
cells that have shown promise. Human adult stem cells have 
shown promise in culture, in vitro, and animal adult stem cells 
have shown promise in vivo.
    So, I think that it is just a few steps now to get the 
adult human stem cells to be used in humans.
    Mr. Bilirakis. I would like to hear from all of you, but my 
time has expired. And I just want to be fair to the rest of the 
members of the committee. Mr. Brown?
    Mr. Brown. Thank you, Mr. Chairman, and you always are. 
Thank you. This morning--and this is a question for the 
scientists on the panel, and then I would like an answer as 
scientific as possible. This morning's edition of The Hill, Dr. 
Doris Platika of Curesis, Inc., a firm that works in adult stem 
cells, is quoted as arguing, ``that embryonic stem cells work 
as a prerequisite for research in adult stem cells.''
    Dr. Michael Bishop, a Nobel laureate, who is now at the 
University of California's Biomedical Complex, a chancellor 
there in San Francisco, said also, ``What scientists need to 
learn is how to direct the cells to develop in one direction or 
another. Once you have that, you have the makings of tissue 
replacement.''
    Would the scientists on the panel comment on the validity 
of these two statements, which seem to suggest that without 
research involving human embryos, the promising treatments for 
diabetes, or spinal injury, or a whole host of medical problems 
might never come to fruition?
    Mr. Newman. Well, without seeing the context, I can just 
say that from what you have said, I have to disagree with those 
statements. The problem of getting an embryo cell or an embryo 
stem cell to become directed toward a differentiated cell type 
is an interesting scientific problem.
    But it is a different problem from getting an adult stem 
cell to be directed toward a particular differentiated cell 
type. And there is no way that studying the embryo stem cells 
is a prerequisite for studying that process in the adult stem 
cells. They are two, distinct scientific issues.
    Mr. Brown. Others? Mr. Okarma, or whoever else wants to 
answer? Mr. Okarma, if you----
    Mr. Okarma. Thank you. Well, first of all, it is true that 
there is recent and exciting, with major medical potential, 
work coming out of the adult stem cell field, a field in which 
I had personally worked for about 12 years in my first company.
    And in no way are any of my comments to be construed as 
being arguing against continuing to work on adult stem cells. 
There are, however, some major issues which provide immense 
advantages for the embryonic stem cell technology, first and 
foremost which is the scalability of the production of 
replacement cells from embryonic stem cells.
    These cells are immortal. We have had them growing in 
culture continuously for over 2 years. They have undergone 450 
population doublings without any change in their ability to be 
turned into functioning neurons, functioning liver cells, 
functioning cardiomyocytes.
    And that transformation process can be scaled so that the 
cells we make can be characterized and experimented upon with 
the same rigor as a drug or a biological. The issue is 
scalability. And inherent in that is the cost of goods.
    The cost of extracting a rare adult stem cell, which grows 
slowly and must be manipulated to grow into a different cell 
from--than what it is programmed to do, will be prohibitive and 
will make the cost of goods of the therapy so high as to 
prevent its commercialization.
    Those are the advantages of the embryonic stem cell, which 
are scalability, rapid growth, and the ability to grow into 
literally all cells of the human body.
    Mr. Brown. Other--yes, Ms.----
    Ms. Norsigian. I just want to say that I believe that some 
reproductive rights advocates would agree that embryonic stem 
cell research should continue. Others would disagree. And the 
issue of scalability and mass production, I think comes into 
play when you think about the development of clonal embryos.
    And although you might argue that we will not know what we 
could have developed or learned by not going down the path of 
allowing clonal embryos, you can also argue that the risks that 
we would take are just simply not worth it.
    I think that is where the vast majority of reproductive 
health advocates I have spoken with are at right now. And even 
though we disagree about the subject of embryo--of embryonic 
stem cell research, the Weldon bill doesn't really address 
that. It only addresses clonal embryos, so that you get away 
from that disagreement.
    You will, in fact, impede mass production in some ways. I 
think that is a given. But I think, given what is at stake, we 
have to say we are going to say no to that, and acknowledge 
that there are some things that we have to bypass.
    Mr. Brown. Dr. Kass?
    Mr. Kass. Yes, your question to Dr. Okarma was answered 
and, I think, made a case for the great benefits of using 
embryonic stem cells as a scale--a scalable source. But he 
didn't yet speak to why they have to be from embryonic clones.
    And if I read his testimony right, I think he argues that 
this would be a great benefit for eventual adult stem cell 
research because you would learn how to reprogram the adult 
nucleus to get adult stem cells in quantity.
    But that technique, as I understand it, has not yet been 
worked out in animals, this kind of reprogramming process. That 
could be done in animal research.
    And if it should turn out 5 years from now that the adult 
stem cells and the non-cloned embryonic stem cells don't 
produce the kind of therapeutic benefits we want, under the 
Weldon bill, there is an opportunity to come back and say, 
``Look, we absolutely--we absolutely have to have cloned 
embryos in order to do this therapeutic work.''
    I think the burden of proof has to be placed there, given 
the great risks that we have all argued for before. And so----
    Mr. Okarma. May I just respond to that specifically?
    Mr. Brown. Sure.
    Mr. Okarma. The burden of proof we accept fully and, in 
fact, has been satisfied. A group in Australia has used nuclear 
transfer in mice to produce blastocysts from which mouse 
embryonic stem cells have been successfully derived, and those 
nuclear transfer derived stem cells have exactly the same 
properties of immortality and pluri-potentiality as embryonic 
stem cells derived from embryos produced sexually in mice.
    So, the data are here, presented and published in peer 
review literature, that the cells produced in that way are, in 
fact, fully functional.
    Mr. Bilirakis. I thank the gentleman. Mr. Greenwood?
    Mr. Greenwood. Thank you, Mr. Chairman. I think we are at a 
very critical point here. Everyone agrees, no reproductive 
cloning. Everyone agrees we want to take advantage of the 
amazing potentiality for curing things that harm, and hurt, and 
kill children and adults in terms of these terrible diseases 
and injuries that inflict us.
    I think--I don't know if maybe--you are shaking your head; 
maybe you don't agree we want to--we want----
    Ms. Norsigian. Not all of the potentiality----
    Mr. Greenwood. Okay, but the point that I am making is it 
seems that there is widespread agreement that if we could find 
ways to cure spinal injury, and Parkinson's, and so on, that we 
would do it.
    What seems to separate us is a question of whether you need 
clonal embryonic research in order to get there. And we have 
heard questions about can't we use placentas? Can't we use 
umbilical cords? Can't we use cadavers? Can't we use adult stem 
cells from bone marrow?
    And that is the critical question? We either get to this 
great potentiality to relieve human suffering in all of those 
other ways, in which case we don't need clonal embryonic 
research, or we can't.
    And I think that is the critical question. And I would like 
Dr. Okarma--I know that you addressed this, to some degree, in 
response to Mr. Brown's question. But this question of 
scalability seems to be critical. It seems to me that if you 
are going to help thousands or hundreds of thousands or 
millions of people, you need to have this issue of scalability 
dealt with. And I wonder if you would address that?
    Mr. Okarma. Well, that is true actually in two contexts. 
The first, as you correctly say, it is relevant for the 
embryonic stem cell technology, itself. It is equally 
important, however, on the point that we are debating here 
today, the use of cloning techniques to arrive at a scalable 
way to produce hysto-compatible cells.
    But let me emphasize once again, the objective of the work 
is not to produce a process that would consume human oocytes or 
which would generate embryos on a case-by-case basis. That 
could never be commercialized for practical----
    Mr. Greenwood. Let me just interrupt you. I always do this 
when you say ``oocytes'' because I am not----
    Mr. Okarma. Egg cells.
    Mr. Greenwood. Egg cells, okay. So, this is not a 
question--it is not the question that in order to meet this 
potential, we need to continually harvest human eggs. This is 
a--this is a bridge technology or bridge research. Is that 
correct?
    Mr. Okarma. Precisely. The objective of the exercise is to 
identify the factors in the eggs that achieve reprogramming so 
that we could use those factors outside of any egg to directly 
transform a skin cell into a heart cell, or a skin cell into a 
brain cell, precisely the challenge Mr. Stupak enunciated in 
his opening statements.
    That is where this work is going. We could never, ethically 
or practically, scale nuclear transfer the way it is currently 
performed, for human therapy.
    The objective of the research is to understand the biology, 
the magic behind the oocyte's ability to take a differentiated 
cell all the way back to development, and allow the gene 
expression pattern to be changed, which is precisely what we 
are trying to learn how to do in order to scalably produce the 
process, allow it to happen, reproducably, in a regulated way, 
and with sufficiently low cost of goods that it can, in fact, 
be widely commercialized.
    Mr. Greenwood. My concern is, I am afraid that people on 
this subcommittee, people on the committee, people in the 
Congress, this administration, are going to take the position 
that although they do want all of these people to be relieved 
of their suffering through these wonderful therapeutic 
opportunities coming up, but they can vote for a Weldon-style 
bill to ban clonal embryonic somatic cell research and feel 
that they haven't--that those two are not in conflict.
    And is it possible that--for members of this committee to 
feel that they can vote for a Weldon research--a Weldon bill 
and still hold out the promise that, in our lifetimes, we are 
going to see the kind of results that you have envisioned?
    Mr. Okarma. In my view, no. No other cell, other than an 
egg cell, has ever been demonstrated to possess the 
reprogramming biology that we are seeking through the research.
    Mr. Greenwood. Mr. Newman, you are----
    Mr. Newman. Yeah, I have something to say about this. 
People may not recognize that embryo stem cells and cloning 
have been available in frogs--well, cloning in frogs for 25 or 
30 years, and embryo stem cells in mice for more than 10 years.
    And this research about what it takes for an egg to 
reprogram a nucleus, well, it is progressing. It is progressing 
slowly. And there is absolutely no reason to do this research 
in humans. It is----
    Mr. Greenwood. Well, Mr. Okarma, is that--do you have a 
difference of opinion? Can we do these with other species, 
mammals and other species, and learn just as much?
    Mr. Okarma. Well, we are certainly doing that, as we speak. 
We are working very diligently in sheep, and in mice, and in 
cow models of nuclear transfer to understand--get hints at the 
animal way that that process is performed.
    But these are only models. And in point of fact, the early 
embryology, as I am sure Dr. Newman will agree, of these 
species versus humans are enormously different. We now have the 
human genome project, right? So, we know what these genes could 
be if we would simply identify the factors in the egg that 
perform this biology.
    We don't have that data base from these animals. The 
animals are only a distant approximation to the condition in 
humans.
    Mr. Greenwood. Thank you. Thank you, Mr. Chairman.
    Mr. Bilirakis. Mr. Deutsch?
    Mr. Deutsch. Thank you, Mr. Chairman. Dr. Kass, you 
testified that once human embryos are produced and available in 
laboratories, it will be virtually impossible to control what 
is done to them. How will the ban you support, the Weldon-
Stupak ban, prevent the actual creation of these cloned 
embryos?
    Mr. Kass. How will it prevent it?
    Mr. Deutsch. Correct.
    Mr. Kass. If you are saying it will not prevent some rascal 
who wants to disobey the law from doing it, I would have to say 
that it won't prevent that, just as the law against incest 
doesn't prevent cases of incest from cropping up.
    But it will deter--it will deter all reputable scientists 
from going down this road. It will give them the opportunity 5 
years down the road to have a report that makes the case that 
we now actually have to have this kind of therapeutic cloning.
    Mr. Deutsch. Let me just follow up.
    Mr. Kass. Please.
    Mr. Deutsch. Why would you believe that the criminal and 
civil penalties contained in the Greenwood-Deutsch bill, which 
are virtually identical to the Weldon-Stupak bill, also do not 
act as effective deterrents to the prohibited acts?
    Mr. Kass. As I say in my testimony, with all due respect, 
the Greenwood-Deutsch bill does not ban the implantation of a 
cloned embryo to initiate a pregnancy. It simply prohibits the 
creation of that embryo with the intent to do so.
    But once the embryo is there, there is no governing 
language on what shall subsequently be done with it.
    Mr. Deutsch. All right, well----
    Mr. Kass. That is partly why----
    Mr. Deutsch. [continuing] let me just follow up. If you 
were to make the changes that you note, specifically 
prohibiting the act of transferring the embryo to a uterus and 
making it a crime to also receive cloned embryo products with 
the intent to initiate a pregnancy, would you then say that the 
Greenwood-Deutsch bill would, in fact, do what you want?
    Mr. Kass. It would be better. It would be better, but it 
wouldn't be good enough. And that is partly because we now know 
that there is a market for reproductive cloning. And I don't 
think, at that particular stage, we are going to have the 
requisite enforceability.
    I would much rather--and if people who--well, I would much 
rather say, given the grave seriousness, not just of curing 
disease, but of going down this road to the brave, new world in 
the post-human future, given the grave seriousness of that, 
that we make every effort to find morally, unproblematic means 
of finding these therapies that we need----
    Mr. Deutsch. But----
    Mr. Kass. [continuing] and not producing this kind of clear 
and present danger at this time.
    Mr. Deutsch. Let me follow up directly to that point 
because in your comments, and actually in Mr. Stupak's 
legislation specifically--and you have said this actually 
several times in your testimony and in answers to questions, 
that if alternatives to therapeutic cloning fail, and animal 
studies demonstrate that embryonic cloning has therapeutic 
potential, and I am going to quote, ``Congress could later 
revisit this issue and consider lifting the ban on cloning of 
embryos.''
    All right, is your position then that the morality of 
cloning embryos is a relative, not absolute, concept?
    Mr. Kass. It is a complicated question for me, and I do not 
have a right-to-life position on this matter. But I think that 
whatever you think about the moral status of the embryo--and 
Professor Fukuyama, I think spoke very movingly about this.
    The human embryo is at least potentially one of us. It is 
not nothing, and it is different from other cells. The attempt 
to call it cell cloning or blastocyst cloning, whatever we do, 
we should call things by their right name. This is nascent 
human life. And it seems to me you create that and treat it as 
mere cellular tissue to be experimented with at our peril.
    One of the things--one of the dehumanizing effects in this 
area already seen is that people can stand and talk about 
creating new human life that is potentially you or potentially 
me--I am not saying it is already a person. I am not saying it 
has rights.
    But it has some kind of standing. And to create that----
    Mr. Deutsch. Well, let me----
    Mr. Kass. [continuing] sort of indifference, it seems to 
me, is already worrisome.
    Mr. Deutsch. Dr. Kass, thank you. Let me--you know, for Mr. 
Okarma, you are in the field doing this research. And I think, 
in some ways, the strongest argument that you have made is your 
actual experiential research, saying that all of the 
alternatives are already secondary alternatives, that what--Dr. 
Kass' comments have already been made in the real world; that 
everything else is not as good; that it is less likely to bring 
successful research outcomes.
    And to me, you know, that--you know, for literally the 
hundreds of thousands, if not millions, of Americans who 
potentially can benefit from this research--I mean, to hear 
that issue I think is the real issue. So, if you can, you know, 
comment to that?
    Mr. Okarma. Well, you are correct in that in our 
professional judgment, the application of nuclear transfer 
research to get to the process we have spoken about, not the 
nuclear transfer process itself, but the use of that biology, 
is the perfect solution to enable regenerative medicine.
    And all others fail in a variety of technical respects. We 
are pursuing other ways to achieve this. So, for example, would 
it be possible to genetically engineer the embryonic stem cell 
to render it immunologically null? It would not, for example, 
potentially evoke an immune response.
    That is theoretically possible. We are working on that. But 
we are asking genetic engineering to do a lot to enable that 
engineered trait to be passed through the manufacturing 
process, all the way down to the differentiated cell that 
would, in fact, be the product.
    And we worry about the durability of that nullness. So if, 
for example, we use that process to repair your heart or mine, 
it is very possible that a year or 2 after the implantation of 
the cell, that nullness is lost, and you suddenly reject that 
tissue, and you are back to where we started from.
    So, the point is well-taken, Mr. Deutsch, that the use of 
nuclear transfer research could lead to a perfect and permanent 
solution to that set of problems.
    Mr. Bilirakis. Dr. Ganske to inquire?
    Mr. Ganske. Mr. Chairman, I am just going to ask one 
question, but I will ask all members of the panel to answer it. 
I apologize because I have had to be gone for part of this. And 
so, you may have spoken to this. I thought the administration 
was quite clear with its statement today that, ``As we 
interpret the bill, it prohibits not only the use of human 
somatic cell nuclear transfer to initiate a pregnancy, but also 
all other applications of somatic cell nuclear transfer with 
human somatic cells, such as cloning to produce cell or tissue-
based therapies. That is consistent with Secretary Thompson's 
and the President's views.''
    I also asked the question, is it the administration's 
position that it should be illegal for anyone to do somatic 
cell nuclear transfer? And the answer was yes. So, I guess my 
question to all of you is, what is your response to that, if we 
could start on my left?
    Mr. Okarma. Well, I----
    Mr. Ganske. And if you could keep your--since there is--
what do we have--eight respondents, maybe to 30 seconds?
    Mr. Okarma. Two points; first, I think it will--it is a 
giant step toward rendering the American biomedical research 
community a second-rate resource. And second, it will clearly 
encourage the exportation of this research to countries that 
are bit more enlightened.
    Mr. Kass. I don't agree. I think the international 
community, for the most part, supports this position. I think 
we could take the lead to achieve--since what I am mostly 
interested in is preventing human cloning and the road that it 
leads to, we need to take a lead in the international 
community, and I think we can do so.
    And if I might just say one word on a question you asked 
the Deputy Secretary before about the importing business and 
stuff that goes elsewhere, as I read the Weldon bill, that 
product of somatic cell nuclear transplantation, the 
trafficking in which is prohibited, are not the drugs that 
might come somewhere else, but simply on the cloned embryonic 
product.
    I think if you look at that language, it is quite clear on 
that.
    Mr. Ganske. But you are--you say you don't agree with their 
position; is that right?
    Mr. Kass. Well, I thought the question was what the 
language--the language of the bill about importing the 
products. I am sorry, I do not agree with Dr.--with Dr. Okarma.
    Mr. Ganske. Okay, next?
    Mr. Kass. Thank you.
    Mr. Guenin. I can imagine only one rationale for the 
administration's position this morning, and that is that the 
administration believes that it is immoral to use an embryo as 
means. And if--there was otherwise no rationale stated. If that 
is the case, then we can surmise that the President will 
announce its opposition to embryonic stem cell research.
    In such a case, I think we will have stymied the most 
promising frontier of biomedical research that has faced us in 
our lifetime for the relief of suffering.
    I think, therefore, it falls to the Congress to consider 
those two issues together, because they are the same problem. 
May an embryo be used as means?
    I would point out that under the so-called rider to the NIH 
appropriations bill that has been discussed with respect to 
embryonic stem cell research, the creation of an embryo for 
research purposes is already prohibited. But here we are today 
still discussing whether it should be.
    So, it seems to me, in all committees of the Congress, 
those two issues will be discussed in the future. And I hope 
the resolution will be an explicit authorization of this line 
of research, rather than placing us in the circumstance of 
statutory gymnastics.
    Mr. Ganske. Mr. Newman?
    Mr. Newman. Insofar as the administration has come out 
against embryo cloning, I would agree with that. On the issue 
of stem cell research using embryos that haven't been produced 
experimentally, I would disagree with the administration's 
position on that.
    I have questions about it, but I wouldn't call for a 
legislative ban on it.
    Mr. Perry. The vast community of patient support groups and 
research advocacy organizations have been waiting on tenter-
hooks for months to hear the administration's position on the 
use of embryonic stem cells for research.
    Today's announcement, I think, presages a negative response 
on that, and it presupposes that we now know enough as 
political leaders to decide which areas of research are going 
to produce the breakthroughs that we all want so much.
    The reality is that in the scientific community, there is 
considerable uncertainty as to the viability long-term of stem 
cells from adult sources.
    There seems to be a lot more power in embryonic stem cells, 
and the cloning technologies, or the cell replication 
technologies, open up yet another avenue that has great 
promise.
    And the decision from the Bush Administration seems to be 
closing one door after another, leaving us with fewer options, 
even as we face an explosion of chronic diseases related to the 
aging of the population.
    Ms. Norsigian. I don't agree with the administration's 
position, but I think there was some confusion this morning as 
I read Claude Allen's statement, which interpreted the Weldon 
bill as prohibiting all applications of somatic cell nuclear 
transfer with human somatic cells.
    He didn't--this didn't say ``human egg cells.'' And then 
under questioning from you, Representative DeGette, I heard 
something different. So, I think there is a little confusion 
about what the administration really is saying right now.
    But I agree with the statements that were made earlier by 
Dr. Kass and Dr. Newman. And I don't read the bill, the Weldon-
Stupak bill, as others have read it, as being much more 
restrictive than it is.
    Mr. Doerflinger. Congressman Ganske, I don't know whether 
you were here for the colloquy between Congressman Stupak and 
Deputy Secretary Allen because he clarified that awkward phrase 
in the testimony and said what the administration is against is 
any use of this technology to make human embryos for cell and 
tissue-based therapy. And we certainly agree with that stance.
    I am rather surprised at the scientific witnesses who are 
now moving over into the debate on the NIH stem cell guidelines 
for embryonic stem cell research because given their new 
testimony, the President would have to be a fool to endorse the 
NIH stem cell guidelines. They have just announced they are 
useless.
    Those guidelines forbid the special creation of embryos for 
research. Dr. Okarma testified that use--that moving on to 
cloning is essential to making these therapies work.
    Apparently, the stem cell guidelines were a bait-and-
switch. As soon as you got to human use, they were going to 
tell us, we forgot to tell you; you had to go to this further 
step that everybody, including the supporters of stem cell 
research, had said was ethically off the table.
    They have now raised the stakes, but they have called into 
serious question their earlier claims about the usefulness of 
these spare embryos.
    Mr. Fukuyama. Well, this whole discussion, I think, has 
conflated embryonic--this embryonic stem cell research with the 
issue before us, which is cloning for research purposes. And I 
think you can support the former and oppose the latter 
perfectly consistently.
    Again, just to repeat myself on the international thing, if 
this research, as the result of the Weldon bill, moves to less 
enlightened countries overseas, so be it. It may be that this 
is the kind of research that will only be done in places like 
China, you know, or Singapore. But I think that is something we 
can live with.
    Mr. Bilirakis. Thank you. The gentleman's time is expired. 
Mr. Stupak?
    Mr. Stupak. Thank you. Dr. Okarma, in your testimony, you 
cite there are two cloning--cloning specific human eggs or, 
excuse me, cloning specific cells, genes, and other tissues 
that do not and cannot lead to a cloned human being.
    Since a live human embryo, by its nature, can lead to a 
cloned human being, you seem to be drawing a line or a 
distinction between therapeutic cloning and human embryo 
cloning. Is that correct?
    Mr. Okarma. Thank you for the opportunity to clarify. It is 
really crucial to understand that what we are supporting is 
research in somatic cell nuclear transfer for the sole purpose 
of understanding its mechanism so that those factors that 
perform--that achieve----
    Mr. Stupak. But----
    Mr. Okarma. [continuing] reprogramming can be isolated and 
used in a scalable way.
    Mr. Stupak. But you were really--no, yes or no, are you 
drawing a distinction then between therapeutic cloning and 
human embryo cloning?
    Mr. Okarma. No.
    Mr. Stupak. Are you saying we need human embryo cloning in 
order to further our therapeutic?
    Mr. Okarma. Yes, I am.
    Mr. Stupak. Okay. Then, our bill bans only the use of 
cloning to create new human embryos. How can you say that we 
would be banning therapeutic cloning?
    Mr. Okarma. I am sorry, I don't understand it.
    Mr. Stupak. All right. So, if our bill bans human embryo--
and you really need human embryo to do your research, right?
    Mr. Okarma. Yes.
    Mr. Stupak. Okay, then let me take this step. Then, how do 
you--as Dr. Kass and others have indicated, where do you draw 
the line then between manipulating that research for hair 
color, for eye color, for intelligence? Once you create that 
human embryo, where do you draw the line?
    How do you do it with either our bill or--well, our bill, 
you just don't do it--or the other bill, the Greenwood bill?
    Mr. Okarma. By intent and by restrictions on the purposes 
to which such a cloned embryo could be placed.
    Mr. Stupak. But see, by ``intent''--then I am really 
confused because on your web-page, the BIO web-page, you say, 
``Some bills do not prohibit the act of cloning a human being 
and focus on the intent or purpose of the researchers. The 
terms intent and purpose used in some bills are criminal law 
concepts which could grant undue discretions to enforcers, 
create uncertainty for researchers, and consequently have a 
broad-chilling effect among researchers.''
    ``Using a specific act as the trigger for violation makes 
it clear that, to all scientists and enforcers, what activities 
are not acceptable.''
    Mr. Okarma. On my web-page?
    Mr. Stupak. On your web-page.
    Mr. Okarma. I am sorry, sir, that is----
    Mr. Stupak. I just pulled it down.
    Mr. Okarma. [continuing] that is not correct.
    Mr. Stupak. On your BIO----
    Mr. Bilirakis. The BIO web-page.
    Mr. Stupak. The web-page from BIO.
    Mr. Okarma. Oh, that is not my----
    Mr. Stupak. I am sorry, but that is the organization you 
represent, isn't it?
    Mr. Okarma. I am representing--I am testifying on behalf of 
BIO. I represent my own company, sir.
    Mr. Stupak. Okay. Well, I am sorry to have the misnomer. I 
thought your--BIO was your company. All right, so I guess that 
would be sort of in conflict to what you are testifying? The 
BIO web-page would be in conflict, then, as to the intent?
    Mr. Okarma. I would have to read it and study it, sir, to 
give you an honest answer.
    Mr. Stupak. All right. The blastocysts that you speak of on 
page 4 of your testimony, isn't that really another term for an 
early, living human embryo?
    Mr. Okarma. Yes, sir, it is, absolutely. And do we not mean 
to obviscate the intent or the actuality of what we are talking 
about here. And we do, as our Ethics Advisory Board constantly 
reminds us, recognize that these early embryos do, in fact, 
have moral status, and they are special cells, which is why we 
are so adamant about their utility for very special 
circumstances, treating these diseases which we view have no 
other alternative.
    Mr. Stupak. Well, would----
    Mr. Okarma. We would also draw the line between the degree 
of moral status that these undifferentiated, unindividuated, 
and unenabled embryos have compared to embryos later in 
gestation.
    Mr. Stupak. But how do you really draw the line? If 
blastocysts are early human embryo, then what--aren't you 
really saying is that reproductive cloning and research cloning 
proceed exactly through the same initial stages, and they 
really aren't separated?
    Mr. Okarma. No, the reason we draw the distinction, the----
    Mr. Stupak. Where and when do you draw the distinction?
    Mr. Okarma. It has to do with the biology. The stage of 
these blastocysts that we use to derive our ES cells, or that 
we would use in the cloning debate we are engaged in----
    Mr. Stupak. Which are the same as living human embryos?
    Mr. Okarma. They are living, human embryos.
    Mr. Stupak. Okay.
    Mr. Okarma. But they are completely unindividuated, which 
means that they have the capability after we would use them to 
divide into two human beings.
    Mr. Stupak. But----
    Mr. Okarma. So, they are not individuated.
    Mr. Stupak. [continuing] how can they----
    Mr. Okarma. They are not----
    Mr. Stupak. [continuing] not be individuated----
    Mr. Okarma. Let me finish, sir.
    Mr. Stupak. Go ahead.
    Mr. Okarma. They are completely undifferentiated in that 
every single cell in that early embryo is exactly like every 
other one. And we know that from doing genetic work on in vitro 
fertilized embryos.
    Those cells can be removed, identified as being--as 
containing or not containing that genetic defect, and those 
which do not, are implanted successfully.
    Mr. Stupak. But we also know, and maybe it is more from our 
side of the aisle here, that frozen embryos in the lab have 
parental rights associated with them. So, how are they, then, 
unidentifiable? And aren't you really creating the issue of 
peril rights and conflicts with privacy rights?
    Mr. Okarma. Well, sir, that is a legal question that I am 
really not competent to answer.
    Mr. Stupak. But you said they were unidentifiable. If we 
already attach, as a country, legal rights to these embryos in 
these stages, which are the same, you said, at the early 
stages, and there are parental rights, then how are they 
unidentifiable?
    Mr. Okarma. Well, I----
    Mr. Stupak. It is no different than the example of Dr. 
Guenin there when he talked about Mary giving her cells to 
research or whatever. What if Mary changes her mind? Does she 
then have parental rights that can be enforced in the courts? 
What if she changed her mind?
    Mr. Guenin. Let me distinguish here. There isn't any 
problem about keeping track of which parents own these. What we 
are discussing is individuation, which is the question of moral 
importance, as to whether we have one embryo, or whether we 
have 2, or 3, or 4.
    Mr. Stupak. Did you say ``more'' or ``moral''?
    Mr. Guenin. Moral.
    Mr. Stupak. Oh, moral.
    Mr. Guenin. So, the individuation idea reflects on the 
possibility of twinning. But so far as tracking who they belong 
to, that is not a problem.
    Mr. Stupak. Dr. Kass?
    Mr. Kass. Just one small point on this argument of non-
individuation; yes, the embryo, as a blastocyst, is not yet 
differentiated. But each one of those blastocysts is different 
from every other one. That is the whole purpose of making the 
argument that you need the identical clone.
    Mr. Stupak. Right.
    Mr. Kass. They are genetically different from one another, 
even if they can subsequently split.
    Mr. Stupak. Even in the early stages?
    Mr. Kass. And they came from specific sources, so they have 
that kind of individual origin.
    Mr. Stupak. Mr. Chairman, are we doing a second round 
later?
    Mr. Bilirakis. I am not disposed on doing that. I suppose 
we could. I don't know that we should go another 5 minutes.
    Mr. Stupak. So, we could follow-up then, at least with 
written questions?
    Mr. Bilirakis. I would say so. You raised the question of 
the support by the bio-tech industry of the Greenwood bill, 
which seems to be in conflict----
    Mr. Stupak. Right.
    Mr. Bilirakis. [continuing] with their web-page.
    Mr. Stupak. Right.
    Mr. Bilirakis. You never did really--did you get an answer 
for that?
    Mr. Stupak. Yeah, I did. It was--I don't think it is fair 
to Dr. Okarma. It is not his--it is his organization, but it is 
not his company, and I asked ``company''. And----
    Mr. Bilirakis. But he----
    Mr. Stupak. [continuing] he is not--you are not here to 
speak on behalf----
    Mr. Bilirakis. But you are representing the biotech 
industry here today?
    Mr. Okarma. Sir, I am not in a position to respond.
    Mr. Bilirakis. You don't know.
    Mr. Stupak. I would just ask the unanimous consent to put 
the biotech webpage----
    Mr. Bilirakis. Without objection, that is the case. I want 
to note that Ms. Erica Yamat, and I may have mispronounced 
that, with Health and Human Services, is here. She has sat here 
the entire hearing.
    I think that is of note because a lot of times, we have 
administration witnesses who will testify and then leave. They 
don't get the benefit of the testimony from sometimes the more 
important witnesses like yourselves. But she is here, and we 
appreciate that.
    The Chair now will yield to Mr. Pitts.
    Mr. Pitts. Thank you, Mr. Chairman. Mr. Okarma, if someone 
were to take a cloned embryo out of your laboratory and implant 
it into a woman's womb, under the Greenwood bill, you or your 
company would not be liable, would you? The Greenwood bill, I 
think, requires that for a violation to have occurred, the 
person who created the cloned embryo had to have done so with 
the intent to implant.
    Mr. Okarma. I believe that is correct, and your point, I 
think, underscores the fact that the Greenwood bill could be 
tightened. Its intent we understand. If there are, in fact, 
legal loopholes and difficulties in enforcement, I believe the 
Greenwood and Deutsch group are very willing to improve the 
language to achieve that end.
    Mr. Pitts. Okay.
    Mr. Greenwood. If the gentleman will yield for 3 seconds. I 
would concur with that. We do intend to tighten that up.
    Mr. Pitts. Your testimony hints that you are already doing 
somatic cell nuclear transfer in humans. Have you already 
attempted human somatic cell nuclear transfer using human 
somatic cell nuclei or human egg cells?
    Mr. Okarma. That was not my testimony. In fact, the work 
that we are doing in the U.K. is all in animals. We do have 
plans to perform nuclear transfer with human material. We have 
not yet begun that.
    Mr. Pitts. Okay. Now, as recently as March 28, before the 
Oversight and Investigations Subcommittee, this BIO Group you 
are representing testified that the FDA already has 
jurisdiction to regulate cloning, and so no new legislation is 
needed or appropriate.
    Do you know why this--is this a change of position? Have 
you concluded that the FDA does not currently have authority 
over human cloning?
    Mr. Okarma. I can't answer that. I just don't know the 
legal foundation of that.
    Mr. Pitts. One other question: What if it could be shown 
that the only effective way to prevent reproductive cloning was 
to stop the process at the first step, that all other measures 
were almost certain to fail to do the job? Would you favor 
that?
    You said in your testimony that the Greenwood bill bans 
reproductive cloning. Actually, it is a 10-year moratorium, 
right?
    Mr. Okarma. Certainly, sir, I am in favor of appropriate 
legislation to prevent human reproductive cloning. The 
hypothetical situation that you ask in your--in your question, 
I don't think is valid. I think there are ways to do that, 
short of prohibiting the research.
    Mr. Pitts. Thank you, Mr. Chairman.
    Mr. Bilirakis. Mr. Strickland?
    Mr. Strickland. Thank you, Mr. Chairman. I will not take my 
full time because I would like to yield to my friend, Mr. 
Stupak in case he has need for additional questions. But I 
would just like to make some observations.
    Much of what we talked about today has involved, I think, 
moral considerations. And I would like to ask each of the panel 
members, if they are willing to do so, to share with us whether 
or not they consider themselves and the position they take a 
moral position?
    Mr. Okarma. Thank you. I certainly view my position, and 
that of our company, and the Ethics Advisory Board, who 
continues to advise us in these matters, as being wholly 
ethical and moral.
    Mr. Strickland. Thank you.
    Mr. Kass. The same.
    Mr. Guenin. The view that I described was an attempt to 
find that, indeed, there is a moral consensus. And so, I 
contribute that, and that is my personal opinion, but as a 
scholarly observation. And I think that that could puncture the 
difficulty here, that there is an unrecognized common 
understanding if we look to the deepest commitments of moral 
views.
    And that is why I mentioned Catholicism because it is the 
most prominent articulation of a religious opposition, that 
there isn't any ground for restraining ourselves when, at no 
cost to a potential life, we can do good. If we forego this 
research, not one more baby will be born.
    Mr. Newman. Well, I think morality is about drawing lines, 
and I think that drawing the line between cloning humans and 
not cloning humans is a relevant and important moral line to 
draw. So, yes, I think that the position that I have presented 
to you is a moral position.
    Mr. Strickland. May I interrupt? My understanding is that 
every one of you here has taken the position that you oppose 
the cloning of human beings, though. Is that not right?
    Mr. Newman. I think that is the case for all the speakers 
on this panel. But I think that the point has been made, and I 
agree with it, that manipulating human embryos by cloning, or 
by genetic engineering, is just an invitation to get used to 
the idea, and eventually have people say well, it is out there; 
it is a product; why can't I use it for my own purposes?
    Mr. Strickland. Okay.
    Mr. Guenin. To be completely forthcoming in answering your 
question, I have to say that I am not prepared to defend 
reproductive cloning because it is presently manifestly unsafe. 
But if it were safe, then I think we--and we probably will in 
some future time have a discussion again.
    I am not prepared to say it would be wrong in all 
instances, but it needs discussion.
    Mr. Perry. I believe it is one of the highest moral 
obligations to relieve human suffering, to extend the benefits 
of health to as many of our fellows as possible, and to use our 
brains and our free institutions to drive toward that goal.
    Ms. Norsigian. I do think it is a moral position, and I 
agree with what Dr. Newman just said. But I also think that it 
is absolutely clear to any of us who have looked at our past 
track record in related fields that there is no way to prevent 
human reproductive cloning if we allow the development of 
clonal embryos.
    And so, if we feel very strongly about that moral line, and 
that we really do not want to see human clones produced, we do 
have to say no to human--to reproductive--excuse me, to embryo 
clones being produced.
    That may mean that some--although I think, at this point, 
we don't have evidence. It is a very broad array of options. 
Some options might not be pursued that would benefit humankind. 
I will admit that.
    But I think that it is a position, a moral position, to say 
that we should not allow for that.
    Mr. Doerflinger. Well, the Catholic Bishops Conference 
certainly thinks that our position is the morally right one. 
But it is not a position based solely on morality. We think 
that on legal, practical, political, and even Constitutional 
grounds, the Weldon bill is an effective and well-written ban 
on cloning, and the Greenwood bill is not.
    Mr. Fukuyama. Well, I have never encountered a speaker that 
identified themselves as taking an immoral position, so I guess 
my position is based on morality.
    But I do think that morality cannot be reduced to utility, 
and the relief of suffering is an important, you know, human 
goal. But it is not the--it is not the only way to define how 
you approach moral issues.
    Mr. Strickland. The reason I asked the question I think is 
very important because someone's morality may be someone else's 
immorality. And I think--I think it is important for us to 
understand that. We set priorities. Is the relief of human 
suffering the highest good?
    I guess what I am describing here is a kind of situational 
ethic. And I am sorry, Mr. Stupak, I have taken all the time, 
but I would just like to end with this comment.
    I don't know which of these bills I am ultimately going to 
support or endorse. But I think this issue is so complicated 
and so important that I question whether or not many of us in 
this Congress are informed well enough to proceed with making a 
decision at this point in time.
    I certainly feel that I am not. I respect each of you and 
your points of view. But there is--there are variations here. 
This is an important issue, and I hope we do not go down a path 
which we will, at some point in the future, regret. And I yield 
back the time I don't have, Mr. Chairman.
    Mr. Bilirakis. Yield back the time you don't have, yeah. We 
have three votes on the floor, so we are going to have to 
finish up. Ms. DeGette?
    Ms. DeGette. Thank you, Mr. Chairman.
    Mr. Bilirakis. Again, we extend courtesy to you.
    Ms. DeGette. I appreciate it. And I would like to speak on 
behalf of all of the members of this panel for calling these--
both of these excellent panels.
    I was just sitting here thinking I have books by many of 
these panelists on my bookshelves. And I think it is a 
wonderful panel.
    Having said that, I just have a couple questions. First of 
all, Mr. Doerflinger was correct about the Ottawa study. That 
was done--that was a study done with pancreatic eyelet cells 
from human cadavers.
    The study I was talking about in my question earlier was an 
NIH study using mouse embryonic stem cells. It was a different 
study, and it was using mouse cells. So, just to clear the 
record up on that; no need for an answer, sir, because I have a 
lot of questions.
    And one question I have for Mr. Okarma, do you know of any 
research laboratories, biomedical research laboratories such as 
yours, who do also in vitro fertilization techniques on 
individuals?
    Mr. Okarma. No, I do not.
    Ms. DeGette. And I guess I--Ms., how do you pronounce your 
name?
    Ms. Norsigian. Norsigian.
    Ms. DeGette. I should know since your book is one of my 
great personal references--references. Do you know, in your 
experience, of any in vitro fertilization clinics that also do 
biomedical research?
    Ms. Norsigian. There are some that are involved, but I 
cannot name them right now. I could get it for you.
    Ms. DeGette. So, they are actually performing----
    Ms. Norsigian. The relate----
    Ms. DeGette. [continuing] research?
    Ms. Norsigian. There is a relationship in terms of 
collaboration, but I am not sure about the----
    Ms. DeGette. Are they actually performing research at the--
at the clinics, do you know?
    Ms. Norsigian. Well, I hope not; not the kind you are 
suggesting.
    Ms. DeGette. Right, okay. The reason I ask that question is 
because we were talking earlier about--about the issue that you 
can't really differentiate between these cells.
    And I believe the administration witness said well, for in 
vitro fertilization, you will be able to tell because that is a 
reproductive clinic where they are transplanting the embryos in 
the uterus. But this kind of research is done in different 
kinds of clinics.
    And I think that--that you have to have that view 
consistently throughout. A lot of folks are saying, ``Well, if 
you allow the somatic cell research, then it will be--then it 
will be too difficult to prevent actual humans from being 
cloned.''
    But I think you could set up that firewall because I think 
those research and the reproductive clinics are two, totally 
different things. And the evidence would bear that out.
    I have a question, a couple questions, for Dr. Kass. I read 
your recent New Republic article with great interest, and I 
really agree with something you say in there, which is that we 
have this problem with cultural pluralism and easygoing 
relativism. So, we can't really tell what we support or not.
    Most of the witnesses here seem to support in vitro 
fertilization, but yet they don't support cloning even for 
research purposes.
    And then, you go on to say, actually earlier in your 
article, that ``Some transforming powers are already here: the 
Pill, in-vitro fertilization, bottled embryos, surrogate wombs, 
cloning, genetic screening, genetic manipulation, organ 
harvesting, mechanical spare parts, brain implants, Ritalin for 
the young, Viagra for the old, Prozac for everyone.''
    So, is what we should do, do you think, on a moral basis, 
is just ban all of this, since all of this is, at essence, 
messing with human biology?
    Mr. Kass. No.
    Ms. DeGette. And where--how do we figure out where that 
line should be, Dr. Kass?
    Mr. Kass. Of course not, no. Thank you very much for the 
question.
    Ms. DeGette. You are welcome.
    Mr. Kass. It is very important, I think, that we not see 
this isolated--this issue before us out of the larger context. 
We are in the midst of acquiring wonderful powers for the 
treatment of disease and the relief of suffering.
    Some of those techniques have other uses that go beyond 
therapy----
    Ms. DeGette. Right.
    Mr. Kass. [continuing] and we should wake up to that fact.
    Ms. DeGette. Right.
    Mr. Kass. Professor Fukuyama said that in most of the areas 
that we will have to make decisions, legislative ban is a blunt 
and inappropriate instrument.
    Ms. DeGette. Right.
    Mr. Kass. It is the wrong way to do most things because the 
good--the benefits and the harms are very closely linked, and 
one needs more sophisticated means of doing the regulation.
    However, here you have an issue where, in fact, for all our 
moral pluralism, the poles continue--and I am not--I don't take 
my moral compass from the Pope, but the American----
    Ms. DeGette. And thank God for that.
    Mr. Kass. Well, the American people want to see 
reproductive cloning stopped. And if we don't act--and this--
Congressman Strickland, if I might, Congress' silence this time 
will be acquiescence if somebody does it while we are silent.
    Ms. DeGette. Well, Doctor, everybody here would agree, 
reproductive cloning should----
    Mr. Kass. Fine.
    Ms. DeGette. [continuing] be banned.
    Mr. Kass. Okay.
    Ms. DeGette. But let us say we could----
    Mr. Bilirakis. Well----
    Ms. DeGette. [continuing] we could somehow stop research--
or reproductive cloning without stopping the research----
    Mr. Bilirakis. I apologize----
    Ms. DeGette. [continuing] cloning. Would that be----
    Mr. Bilirakis. [continuing] to the gentlelady----
    Ms. DeGette. [continuing] acceptable?
    Mr. Bilirakis. [continuing] but we have about 5 minutes 
left for a vote. We are going to have to get going there. Can 
you take 30 seconds to respond?
    Ms. DeGette. Thank you.
    Mr. Kass. I am very long-winded. No, I think--this is so 
serious that I think we should not--we should lock the barn 
door before the embryo clones get out into reproductive places.
    Ms. DeGette. Thank you.
    Mr. Bilirakis. Honestly, I agree with Ms. DeGette. This was 
a terrific panel. We hold these hearings hopefully without pre-
deciding, hopefully to learn. If anyone sitting in on these 
hearings has not learned an awful lot about this subject, I 
think they have had their ears bottled up.
    We appreciate you being here very, very much. We will have 
questions in writing to you. We would hope that you would be 
willing to respond to those in a timely fashion.
    And second of all, any other ideas that you all have that 
might be helpful in terms of helping us make our decisions on 
this very complex and significant subject, we would welcome 
them with open arms. And again, our gratitude. Thank you. This 
hearing is now adjourned.
    [Whereupon, at 2:22 p.m, the subcommittee was adjourned.]
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