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

              MEDICAL SCIENCE AND BIOETHICS: ATTACK OF THE CLONES?

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

                                    HEARING

                                   before the

                       SUBCOMMITTEE ON CRIMINAL JUSTICE,
                        DRUG POLICY AND HUMAN RESOURCES

                                     of the

                                  COMMITTEE ON
                               GOVERNMENT REFORM

                            HOUSE OF REPRESENTATIVES

                          ONE HUNDRED SEVENTH CONGRESS

                                 SECOND SESSION

                                   __________

                                  MAY 15, 2002

                                   __________

                               Serial No. 107-194

                                   __________

           Printed for the use of the Committee on Government Reform

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

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                         COMMITTEE ON GOVERNMENT REFORM

                         DAN BURTON, Indiana, Chairman
    BENJAMIN A. GILMAN, New York         HENRY A. WAXMAN, California
    CONSTANCE A. MORELLA, Maryland       TOM LANTOS, California
    CHRISTOPHER SHAYS, Connecticut       MAJOR R. OWENS, New York
    ILEANA ROS-LEHTINEN, Florida         EDOLPHUS TOWNS, New York
    JOHN M. McHUGH, New York             PAUL E. KANJORSKI, Pennsylvania
    STEPHEN HORN, California             PATSY T. MINK, Hawaii
    JOHN L. MICA, Florida                CAROLYN B. MALONEY, New York
    THOMAS M. DAVIS, Virginia            ELEANOR HOLMES NORTON, Washington,
    MARK E. SOUDER, Indiana                  DC
    STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
    BOB BARR, Georgia                    DENNIS J. KUCINICH, Ohio
    DAN MILLER, Florida                  ROD R. BLAGOJEVICH, Illinois
    DOUG OSE, California                 DANNY K. DAVIS, Illinois
    RON LEWIS, Kentucky                  JOHN F. TIERNEY, Massachusetts
    JO ANN DAVIS, Virginia               JIM TURNER, Texas
    TODD RUSSELL PLATTS, Pennsylvania    THOMAS H. ALLEN, Maine
    DAVE WELDON, Florida                 JANICE D. SCHAKOWSKY, Illinois
    CHRIS CANNON, Utah                   WM. LACY CLAY, Missouri
    ADAM H. PUTNAM, Florida              DIANE E. WATSON, California
    C.L. ``BUTCH'' OTTER, Idaho          STEPHEN F. LYNCH, Massachusetts
    EDWARD L. SCHROCK, Virginia                      ------
    JOHN J. DUNCAN, Jr., Tennessee       BERNARD SANDERS, Vermont
    ------ ------                            (Independent)

                          Kevin Binger, Staff Director
                     Daniel R. Moll, Deputy Staff Director
                         James C. Wilson, Chief Counsel
                         Robert A. Briggs, Chief Clerk
                     Phil Schiliro, Minority Staff Director

       Subcommittee on Criminal Justice, Drug Policy and Human Resources

                       MARK E. SOUDER, Indiana, Chairman
    BENJAMIN A. GILMAN, New York         ELIJAH E. CUMMINGS, Maryland
    ILEANA ROS-LEHTINEN, Florida         ROD R. BLAGOJEVICH, Illinois
    JOHN L. MICA, Florida,               BERNARD SANDERS, Vermont
    BOB BARR, Georgia                    DANNY K. DAVIS, Illinois
    DAN MILLER, Florida                  JIM TURNER, Texas
    DOUG OSE, California                 THOMAS H. ALLEN, Maine
    JO ANN DAVIS, Virginia               JANICE D. SCHAKOWKY, Illinois
    DAVE WELDON, Florida

                                   Ex Officio

    DAN BURTON, Indiana                  HENRY A. WAXMAN, California
                       Christopher Donesa, Staff Director
                    Roland Foster, Professional Staff Member
                              Conn Carroll, Clerk
                      Julian A. Haywood, Minority Counsel

                                C O N T E N T S

                                  ----------
                                                                       Page
    Hearing held on May 15, 2002.....................................     1
    Statement of:
        Kelly, James, patient advocate; Elizabeth Howard, patient
          advocate; and Judy Norsigian, Boston Women's Health Book
          Collective.................................................    55
        Usala, Anton-Lewis, M.D., Brody School of Medicine, East
          Carolina University; Bryan Cowan, M.D., department of OB/
          GYN, University of Mississippi Medical Center; and
          Panayiotis Zavos, the Andrology Institute of America.......    10
    Letters, statements, etc., submitted for the record by:
        Cowan, Bryan, M.D., department of OB/GYN, University of
          Mississippi Medical Center, prepared statement of..........    19
        Howard, Elizabeth, patient advocate, prepared statement of...    69
        Kelly, James, patient advocate, prepared statement of........    59
        Norsigian, Judy, Boston Women's Health Book Collective,
          prepared statement of......................................    78
        Souder, Hon. Mark E., a Representative in Congress from the
          State of Indiana, prepared statement of....................     4
        Usala, Anton-Lewis, M.D., Brody School of Medicine, East
          Carolina University, prepared statement of.................    13
        Zavos, Panayiotis, the Andrology Institute of America,
          prepared statement of......................................    39

              MEDICAL SCIENCE AND BIOETHICS: ATTACK OF THE CLONES?

                                  ----------

                            WEDNESDAY, MAY 15, 2002

                      House of Representatives,
     Subcommittee on Criminal Justice, Drug Policy and
                                       Human Resources,
                                Committee on Government Reform,
                                                        Washington, DC.
        The subcommittee met, pursuant to notice, at 1:05 p.m., in
    room 2154, Rayburn House Office Building, Hon. Mark E. Souder
    (chairman of the subcommittee) presiding.
        Present: Representatives Souder, JoAnn Davis of Virginia,
    Weldon, and Cummings.
        Staff present: Chris Donesa, staff director and chief
    counsel; Roland Foster, professional staff member; Conn
    Carroll, clerk; Julian A. Haywood, minority counsel; and Earley
    Green, minority assistant clerk.
        Mr. Souder. The subcommittee will now come to order.
        We will start with my opening statement. Good afternoon and
    thank you all for being here today. Today's hearing will
    examine the scientific, medical, and ethical issues related to
    human cloning, and examine the need for Federal law in this
    area.
        Scientists stunned the world 5 years ago when they
    announced the creation of the world's first clone, a sheep
    named Dolly. In the short time since, cattle, goats, mice,
    rabbits, and a cat have also been cloned. Efforts are now
    underway in the United States and elsewhere to create a cloned
    human being.
        The President, the public, religious leaders, and many
    scientists have all expressed their disapproval of efforts to
    conduct human cloning for any reason, and the House of
    Representatives overwhelmingly approved legislation last year,
    authored by Dr. David Weldon, a member of this subcommittee, to
    prohibit all human cloning.
        Opposition to human cloning is based upon both ethical and
    scientific considerations. All clones so far have been found to
    suffer from severe abnormalities, premature aging, and early
    death. In addition to these problems, cloning also poses
    significant health risks to the mother of a clone and to the
    women from whom the eggs necessary for cloning are harvested.
        These dangers have not, however, deterred some from
    attempting to produce cloned humans. We know scientists, such
    as Dr. Panos Zavos, who is with us today, are pursuing cloning
    as a means of producing live human offspring, while others seek
    to create cloned human embryos in order to destroy them for
    scientific research, with the hopes that such research may
    potentially yield treatments or cures.
        Regardless of the goals of those who are attempting to
    manufacture human clones, the fact is that cloning, for
    whatever purpose, creates human life.
        There is no difference between a cloned human embryo
    created for procreation or for research purposes. Whether or
    not the newly created embryo is implanted with the intent of
    reproduction or destroyed for the purpose of research is
    irrelevant to the fact that a cloned human being has been
    created. Therefore, a prohibition on cloning that is limited
    only to preventing the implantation of a cloned embryo, as some
    have suggested, in effect legalizes human cloning, and raises
    additional ethical dilemmas.
        A ban that permits embryonic clones to be created but
    forbids them to be implanted in utero legally requires the
    destruction of human life and criminalizes efforts to preserve
    and protect such life, once created.
        Under a partial ban that permits the creation of cloned
    embryos for research, human embryos would be manufactured in
    numerous laboratories around the country. Once cloned embryos
    are available, it would be virtually impossible to monitor or
    control what is done with them.
        Stockpiles of embryonic human clones could be produced,
    bought, and sold. Implantation of cloned embryos, an easy
    procedure, could take place out of sight, and not even the most
    elaborate and intrusive regulations and policing could detect
    or prevent the initiation of a clonal pregnancy.
        Scientists agree that once begun, a clonal pregnancy would
    be almost impossible to detect or differentiate from a routine
    pregnancy, and if detected, what could the government do? Would
    a woman with a clonal pregnancy be forced or coerced with
    severe penalties to abort the child? Allowing human cloning for
    research brings us further down the slippery slope that
    devalues the sanctity of human life.
        Not even a year ago, this subcommittee held a hearing on
    research involving the destruction of human embryos. At that
    time, supporters of embryonic stem cell research, which
    requires the destruction of a human embryo, found ``extremely
    troubling'' the announcement that embryos were being created in
    order to conduct stem cell research. There was a consensus
    among opponents and supporters of embryonic stem cell research
    that embryos should never be created solely and specifically
    for research. But now that is exactly what the proponents of
    research cloning are demanding.
        If we now permit the manufacturing of human embryos for
    research, where do we draw the line? Do we allow cloned embryos
    to grow for 5 days before they are destroyed in the process of
    extracting their stem cells? What about removing tissues from
    5-week-old embryos? Should we consider harvesting the organs
    from 5-month-old fetuses? What will those who support
    destructive research next claim is necessary in the name of
    research?
        We must finally draw the line that stops the exploitation
    of any form of human life. Cloning, regardless of intent,
    reduces human life to a commodity that is created and destroyed
    for convenience. And despite the claims to the contrary, there
    is no evidence that cloning can or ever will cure diseases.
    Such statements are purely speculative, and pursuing cloning
    merely diverts limited resources away from more promising
    research that is already producing promising results.
        It is clear that a ban that applies only to reproductive
    cloning is a false ban, which merely creates an illusion that
    human cloning has been prohibited. The fact is that all cloning
    is reproductive cloning, and therefore human cloning for any
    reason should be banned.
        Thank you all for being here today. We look forward to
    hearing the testimony of each of our witnesses.
        [The prepared statement of Hon. Mark E. Souder follows:]

        [GRAPHIC] [TIFF OMITTED] T6435.001

        [GRAPHIC] [TIFF OMITTED] T6435.002

        [GRAPHIC] [TIFF OMITTED] T6435.003

        [GRAPHIC] [TIFF OMITTED] T6435.004

        Mr. Souder. I yield to Dr. Weldon for an opening statement.
        Dr. Weldon. Thank you, Mr. Chairman, and thank you for
    calling this very important hearing.
        As a physician who still sees patients on a regular basis,
    I have a keen interest in developing cures for diseases that
    plague so many of my patients. We all have family members who
    suffer from diseases, and we all hope for cures for these
    conditions.
        I have been and remain a supporter of the NIH, and I have
    been pleased to take an active role in doubling the funding for
    NIH so we can pursue the necessary cures.
        Scientists have announced they are working to clone human
    beings. Today we will hear testimony from one such researcher.
    The complete ban on human cloning passed the House on last July
    and was supported by a wide bipartisan margin, 265 to 162. It
    was supported by liberals, progressives, conservatives, pro-
    life, pro-choice Members, and many supporters, I will note, of
    embryo stem cell research.
        Clearly, the support for a complete ban on human cloning is
    very broad-based support. Why is that so? Because human cloning
    is a threat to society. Human cloning moved from science
    fiction to reality when researchers in 1997 cloned Dolly the
    sheep. For the first time, we had the power to redesign human
    beings at a basic level.
        Human cloning is not about procreation, it is about baby
    manufacture. It does not produce a child with two parents, it
    creates a duplicate of an existing human being. Human cloning
    is not a reproductive right, it is about eugenics and depriving
    children of their genetic individuality.
        No one has the right to alter the human species in such a
    fundamental way. No one has the right to turn human procreation
    into baby manufacture, and no one has the right to create
    children to their own specifications.
        This is why it is very important that the other body pass a
    complete ban like the ban that passed the House. This is why
    the Senate needs to stop delaying and act on this very, very
    important issue.
        I just want to underscore a very, very important point that
    I think we need to make. I was hoping that we would have a
    Justice Department witness at this hearing today. As I
    understand it, they were unable on the short notice to provide
    someone, but they have provided us a statement. I think this is
    a very, very important point, Mr. Chairman.
        There are several proposals in the other body that are
    similar to some of the ideas that were floated here in the
    House of Representatives last year that entailed various bans
    on just so-called reproductive cloning, banning the
    implantation of a cloned embryo into a woman, but allowing
    unfettered embryo cloning for either scientific purposes or
    other purposes.
        The concern that I have had--and I have a statement from
    the Justice Department validating this--is that these
    proposals, such as proposal S. 2439 introduced by Senators
    Specter, Feinstein and Kennedy, along with others, are
    essentially unenforceable.
        Specifically, what the Justice Department talks about in
    their statement is that what they attempt to make illegal, the
    implantation of a cloned embryo into a woman for reproductive
    purposes, is actually a procedure that is occurring daily all
    over the country on a regular basis in fertility clinics, where
    these fertility clinics are taking sexually fertilized embryos
    and implanting them in women.
        Let me just quote from the statement from the Justice
    Department. ``hence, there is no visible difference between the
    prohibited activity and the permitted activity, both of which
    would presumably be conducted within the privacy of a hospital
    or medical office. Entrusted with enforcing such a limited ban,
    law enforcement would be in the unenviable position of having
    to impose new and unprecedented scrutiny over doctors and
    fertility clinics and/or research facilities to ensure that
    only fertilized embryos were being transferred to would-be
    mothers.''
        This is a very, very critical point, and a point I made in
    argument and debate in the House, and it is an important point
    that the supporters of the Kennedy-Feinstein approach have not
    really successfully addressed: How on Earth would law
    enforcement enforce such a ban as they are proposing?
        Mr. Chairman, I would just like to ask that we strongly
    consider the possibility of having a second hearing next month
    and bringing the Justice Department in here to elaborate on
    this. As I understand it, the vote in the Senate has been put
    off again, so this issue I think is still very, very timely and
    very much worth discussion.
        Mr. Souder. I thank the gentleman from Florida. We will
    certainly work hard on the calendar to see if we can
    accommodate both the Justice Department and possibly HHS in an
    enforcement hearing.
        Dr. Weldon. I thank the chairman. Might I also ask
    unanimous consent to insert this statement in the record.
        Mr. Souder. Hearing no objection, so ordered.
        Before proceeding, I would like to take care of a couple of
    procedural matters.
        First, I ask unanimous consent that all Members have 5
    legislative days to submit written statements and questions for
    the hearing record, and that any answers to written questions
    provided by the witnesses also be included in the record.
        Without objection, it is so ordered.
        Second, I ask unanimous consent that all exhibits,
    documents, and other materials referred to by Members and the
    witnesses may be included in the hearing record, and that all
    Members be permitted to revise and extend their remarks.
        Without objection, it is so ordered.
        If each of the witnesses on the first panel could stand and
    raise your right hand, I will administer an oath. This is an
    oversight committee, so it is standard practice that everyone
    has to take the oath.
        [Witnesses sworn.]
        Mr. Souder. Let the record show the witnesses have each
    answered in the affirmative.
        Witnesses will each be asked to now summarize your opening
    statements. You have 5 minutes for testimony. Your full
    statement will be included in the record as well as any other
    materials that you wish to submit.
        At this time, we will start with Dr. Usala.

        STATEMENTS OF ANTON-LEWIS USALA, M.D., BRODY SCHOOL OF
        MEDICINE, EAST CAROLINA UNIVERSITY; BRYAN COWAN, M.D.,
    DEPARTMENT OF OB/GYN, UNIVERSITY OF MISSISSIPPI MEDICAL CENTER;
        AND PANAYIOTIS ZAVOS, THE ANDROLOGY INSTITUTE OF AMERICA

        Dr. Usala. Chronic disease states, such as Type 1 diabetes,
    Parkinson's Disease, and spinal cord injury result from the
    destruction of specific cells. Replacement of these tissues may
    provide immense relief, and possibly cure of the disease. One
    approach to replace these tissues is to find acceptable
    transplantation sources and implant donor cells into a patient.
    If these cells are derived from a source other than the
    patient, there will be problems with rejecting the foreign
    transplant material. Cloned patient cells, that is, cells that
    are induced to replicate with the same DNA template as the
    patient's, do not have foreign markers and theoretically would
    not be rejected. However, cloned cells, as well as other cells,
    still must overcome the problem of appropriate integration into
    the transplant site in order to replace the function of the
    destroyed tissues.
        Shortly after conception, the human being has a unique DNA
    template from which all other cells are generated. A
    differentiated heart cell has the same DNA template as a
    differentiated skin cell, and they both have the same DNA
    template as the undifferentiated cells currently in
    embryogenesis.
        Different areas of the DNA template are promoted and
    repressed, resulting in different cell functions. Which area of
    the DNA template is promoted and repressed is largely
    determined by environmental factors outside the cell. Thus, it
    is hypothetically possible to induce any cell to become any
    other kind of cell if the right environment were provided.
        The mass of cells that begins this replication and
    differentiation, either shortly after conception or induction
    through nuclear transfer, defines the beginning of any mammal's
    life. The continuum of human life thus starts at the beginning
    of the complex, explosive process of cellular DNA
    differentiation during embryogenesis and continues throughout a
    person's life until death. One cannot stop the continuum at any
    one point and say it is not human life simply because it lacks
    the ability to do certain functions.
        When the mass of cells has feelings or reason is subject to
    debate. When it begins as human life is a biologic fact. The
    developing embryo is surrounded by different proteins and
    factors than later in development, but the DNA template remains
    the same throughout the person's life.
        My hypothesis was that if the correct embryonic environment
    could be duplicated, a patient's cells may be able to be
    induced to regenerate within a given site, as they rapidly did
    earlier in the patient's life, during embryogenesis. This would
    result in totally compatible, integrated replacement tissue for
    the disease being treated.
        I tested this concept in an FDA-monitored feasibility
    study. Human patients with diabetic foot ulcers were injected
    with an artificially made copolymer I designed that resembled
    early embryonic proteins. It needs to be emphasized that no
    cells were transplanted into the patients. Their ulcers were
    injected only with the copolymer protein structure.
        If I could have the first slide.
        Shown here is the first large animal which I injected the
    copolymer into. This was a spontaneously diabetic dog that was
    brought to a veterinarian for euthanasia. After 2 months of IV
    antibiotic therapy and efforts at surgical closure, the dog's
    diabetic ulcers persisted. This is very similar to what we see
    in human patients with diabetic foot ulcers. After many years
    of diabetes, the circulation is damaged and healing can no
    longer take place effectively.
        Up on the left panel we see the ulcer. That was there for 2
    months. You can see part of the elbow bone poking through. That
    was before the injection, which we injected around the
    periphery and through the center. Two days later, as you can
    see, the ulcer became very, very erythematous but not swollen.
    This was not inflammation. We knew from earlier studies that we
    induced rapid, explosive growth of new blood vessels with new
    red blood cells in them.
        By 6 days, the animal's chronic ulcer was completely
    closed, and you can see the new hair follicles growing. Again,
    no cells were injected. This was just induction of what each
    one of our cells contains: the power to regenerate if put in
    the proper environment.
        Next slide, please.
        After review, the FDA allowed us to try a feasibility
    trial. We took six patients with chronic diabetic foot ulcers
    at the University of North Carolina at Chapel Hill to their
    chronic wound care center.
        This is a photo of an ulcer that was 4 years in duration.
    This patient was treated every 2 weeks for 4 years in an
    attempt to get this ulcer to close.
        Next slide, please.
        This is the ulcer 15 minutes after the initial injection of
    the copolymer matrix. You can see it looks a little different.
    You can see the spots where the needle was placed to inject one
    time this scaffolding.
        Next slide, please.
        Here you have 7 days. You can see what happened, the
    explosive regeneration that has filled the ulcer that was there
    for 4 years. This is very delicate tissue, and it is highly
    vascularized. How do we know? The surgeon poked it and you can
    see the blood exuding out.
        Next slide, please.
        This was day 14. It continued to grow with the
    keratinization occurring.
        Next slide.
        This was at 1 month.
        Next slide.
        The same patient at 2 months.
        There he was at 3 months.
        Four weeks later, this man was able to dance at his
    daughter's wedding. He was not able to walk for the previous 4
    years.
        Transplantation strategies, whether derived from foreign
    donors or cloned cells from the patients themselves, are
    clearly not the only approach to replace damaged tissue. Other
    avenues are much further along in clinical trials and should be
    considered as a first approach for study.
        Claims that only human embryonic stem cells or cloned
    tissues can overcome problems of rejection are false. Indeed,
    the patient's existing cells provide the most rational source
    for fully integrating replacement tissue, as occurs during
    embryogenesis.
        Thank you.
        Mr. Souder. Thank you very much.
        [The prepared statement of Dr. Usala follows:]

        [GRAPHIC] [TIFF OMITTED] T6435.005

        [GRAPHIC] [TIFF OMITTED] T6435.006

        [GRAPHIC] [TIFF OMITTED] T6435.007

        Dr. Cowan.
        Dr. Cowan. Good afternoon, Mr. Chairman and members of the
    committee. Thank you for holding this important hearing and for
    inviting us to participate.
        I am Dr. Bryan Cowan, professor of obstetrics and
    gynecology at the University of Mississippi Medical Center in
    Jackson, Mississippi. I am here today representing the American
    Society of Reproductive Medicine, ASRM. ASRM is a national
    professional organization whose nearly 9,000 members are
    dedicated to advancing knowledge and expertise in reproductive
    medicine and biology and treating infertility. Our membership
    is made up of physicians, reproductive biologists, laboratory
    directors, nurses, and mental health professionals, all of whom
    are dedicated to advancing the cause of reproductive medicine.
        ASRM supports a ban on reproductive cloning at this time
    but endorses somatic cell nuclear transfer for research. And
    let me tell you why. ASRM is on record as opposing attempts at
    human reproductive cloning since the announcement of the
    successful cloning of a sheep in 1997. In November 2000, our
    ethics committee released a very thoughtful report on somatic
    cell nuclear transfer, both therapeutic and reproductive
    cloning, and concluded that human reproductive cloning was not
    safe and efficacy of the procedure had not been established.
        We have learned how to use cloning with microscopic
    organisms, and any of us who gardens knows how cloning works.
    Some species of animals, such as frogs and mice, can be cloned
    quite successfully. It appears that in larger, more complicated
    animals, cloning can be made to work but is not yet reliable.
    Cows and sheep have been cloned, but there have been many
    problems that, while unfortunate in animals, are completely
    unacceptable in human beings.
        Until there are better results in animals, we have no
    business even considering reproductive cloning in human beings.
    Thus, we feel it would be entirely appropriate for the Congress
    to make human reproductive cloning illegal. We are concerned,
    however, that much of the proposed legislation, including the
    bill passed by this body last summer, simply goes too far.
        Research using somatic cell nuclear transfer holds
    tremendous promise. If we take an egg, remove its nucleus and
    thus the genetic material, replace that nucleus with the DNA
    from the donated somatic cell, spark that cell to artificially
    begin cell division and use the resultant stem cell, we may
    unlock the cures for diabetes, Parkinson's Disease,
    cardiovascular disease and spinal cord injury, just to name a
    few conditions. This science is in its infancy. To slam the
    door shut before we understand it would be unconscionable.
        This view, to prohibit reproductive cloning but to allow
    research into somatic cell nuclear transfer, is not just my
    view and not just the view of the ASRM. Rather, it is without
    question the view of nearly every serious scientific and
    medical group that has examined the issue.
        The ASRM is a founding member of the Coalition for the
    Advancement of Medical Research, a coalition that supports this
    view. Members include the American Society for Cell Biology,
    the American Association of Neurological Surgeons, the Congress
    of Neurologic Surgeons, the American Society of Hematology, and
    the American Medical Association, just to name a few.
        In addition, the National Academy of Sciences, a Blue
    Ribbon Commission in California, and a letter signed by 40
    Nobel Laureates, concluded that the scientific and medical
    communities are clear: reproductive cloning should be banned,
    but research utilizing related techniques must be allowed to go
    forward.
        Yes, there are individual scientists who would defend
    reproductive cloning, as well as individuals who would support
    a prohibition even on related research, but there is a clear
    consensus in the mainstream scientific community that the
    potential advantages of somatic cell nuclear transfer are so
    great that the ethical concerns of a minority must not be used
    to prohibit it. Instead, we should develop wise policy
    decisions that can solve these ethical concerns.
        We have seen firsthand in the United States how fear and
    unwise policy decisions can make it extremely difficult for us
    to improve the treatments we have available to offer our
    patients. The decision to deny Federal funds for research
    involving human IVF has harmed the millions of Americans
    suffering from infertility. History is replete with examples of
    government attempts to block scientific and medical
    advancement, almost always with negative results.
        In the 17th century, Galileo was arrested for arguing that
    the planets revolved around the sun. In the 19th century, the
    Church of England argued that providing anesthesia during
    childbirth violated Biblical tenets, and attempted to outlaw
    it. Today, organ transplantation and IVF were hugely
    controversial upon their introduction, and we were greeted with
    the same objections raised here against cloning. Thankfully,
    this knowledge was not made illegal, and today we can
    successfully use these advances to help patients every single
    day.
        There have also been concerns raised about the use of
    donated eggs for therapeutic cloning. We have been using egg
    donation to assist reproduction for more than 10 years. To date
    in the United States, more than 15,000 children have been born
    into loving families using this important therapy.
        Over the years, the ASRM has developed a strict set of
    guidelines on how to go about egg donation and how to protect
    egg donors. There is no reason these standards cannot be
    applied to all eggs used for somatic cell nuclear transfer
    research and guarantee patient privacy and protection.
        The real goal of most of this research would be to develop
    a better understanding of how an egg works. Once we know how an
    egg deregulates the DNA after somatic transfer, this knowledge
    would obviate or even eliminate the need for more eggs to be
    used to develop stem cells. Any claims as to the number of eggs
    that would be needed are, frankly, speculation.
        I am fearful that a negative decision may be made on
    somatic cell nuclear transfer that will cause needless
    suffering for patients with heart disease, diabetes,
    Parkinson's, or others. Please do not make their situations
    worse by enacting a new and unneeded prohibition on research
    just because those techniques might allow reproductive cloning
    to occur. As a physician, I must tell you how important hope is
    to our patients. By outlawing this very promising research, you
    would be denying hope to millions of Americans and their loved
    ones.
        I thank you for your time, and would be happy to answer any
    questions. Thank you.
        Mr. Souder. Thank you.
        [The prepared statement of Dr. Cowan follows:]

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        Mr. Souder. Dr. Zavos.
        Mr. Zavos. Good afternoon, everyone. Thank you, Mr.
    Chairman, for inviting me for this very interesting session.
        I am a reproductive specialist and scientist that has
    dedicated the last 24 years of my life in helping infertile
    couples have children and complete their biological cycle. I
    care about couples suffering from infertility. Do you care
    about infertility?
        Infertility affects approximately 10 to 15 percent of the
    couples of reproductive age throughout the developing world.
    There are 10 to 12 million infertile couples in the United
    States alone. Assisted reproductive technologies have played a
    major role in treating various causes of infertility. In fact,
    about 65 percent of the couples who seek medical help will
    eventually succeed in having a child. However, in cases where
    there are no sperm or eggs present, possibly due to loss of
    testicular or ovarian function, for those couples, they must go
    to other options such as sperm donation, oocyte donation, or
    adoption.
        If you care about these unfortunate infertile couples, why
    are you considering legislation that would make both them and
    the people that are trying to help them criminals?
    Criminalizing human reproductive cloning in the United States
    will only make it less safe and more costly for these infertile
    couples. They will be forced to travel outside the United
    States to pursue their dream of creating a family.
        After all, according to the Americans with Disabilities
    Act, infertility is a disability, and reproduction is major
    life activity for purposes of the ADA. In light of this, it is
    the right of each and every American citizen to bear a child.
        Cloning cannot be curbed. Mr. Chairman, experts state
    repeatedly, and history proves the point very clearly, that
    scientists will clone, even if President Bush and the Congress
    will ban it. The House of Representatives may vote against
    human cloning, but that will not stop scientists from doing it
    and people from wanting it.
        In the words of an infertility patient who wants her own
    genetic baby so badly that she would go wherever she had to in
    order to clone either herself or her husband, ``If they called
    me right now and said, `We are paying for everything and giving
    you the chance to have your own genetic child,' I would be on
    the plane so fast it is not even funny.''
        In the words of a bioethicist, ``The best way to control
    this research is to fund it by the Federal Government, because
    then you create rules and regulate it.''
        In my words, Mr. Chairman, the genie is out of the bottle
    and it keeps getting bigger every day. There is no way this
    genie is going back into the bottle. Let us find ways to
    develop it properly and disseminate it safely.
        If you are concerned about the risks of human cloning, the
    proper approach is to fund it and then institute regulations
    that will ensure that human cloning is done properly, with a
    minimum of risks to the baby, just as is done in other medical
    and drug innovations. This is what our team is working on, and
    we will not go forward with human cloning until the risks are
    comparable with other IVF procedures.
        We have no intentions of doing this in the U.S.A., whether
    any legislation is passed for or against this technology.
    Furthermore, Mr. Chairman, we have no intentions of breaking
    the laws of this country or any other country to accomplish
    this. We are law-abiding citizens of this great Nation of ours,
    but we are a compassionate group of people that wish to help
    our fellow men and women to have the gift of life, the gift of
    life that most of us have been so fortunate to have to enjoy
    and take for granted. Let us not be so uncompassionate and so
    insensitive to tell those people that we are not willing to
    listen to them and are unwilling to help them. This is not what
    our country's Constitution and principles are all about. We
    believe in creating families, not preventing them. In God we
    trust.
        Reproductive Regeneration as a Means of Infertility
    Treatment. It is quite evident to us, along with other
    competent human reproductive specialists, that with further
    elucidation of the mechanisms involved during the process of
    embryogenesis, careful tailoring of subsequently developed
    culture conditions and manipulation strategies, and appropriate
    screening methods, will eventually allow infertile couples to
    safely have healthy, genetically related children through
    somatic cell nuclear transfer methods.
        The Opponents of Human Cloning or Reproductive
    Regeneration. The most prominent opponents to human
    reproductive regeneration and spokesmen for animal cloning are
    Drs. Ian Wilmut from the Roslin Institute and Rudolph Jaenisch
    from the Massachusetts Institute of Technology, MIT, who have
    misled and have misdirected the public and its leadership for
    their very own gains, whatever those gains might be.
        If one reviews the animal cloning literature, which is so
    eloquently alluded to as being totally destructive in your
    opening statements today, Mr. Chairman, I must tell you that
    one can deduce that the poor cloning success rates noted by
    ``the animal cloners'' are mainly due to experiments that are
    poorly designed, poorly executed, approached, understood, and
    interpreted, and these experiments were mostly done under
    nonsterile and uncontrolled conditions and environments and
    having a hit-and-miss type of an outcome.
        According to a recent article in Time Magazine, Wilmut and
    Jaenisch stated that animal cloning is inefficient and is
    likely to remain so for the foreseeable future. On the
    contrary, a number of studies have already demonstrated far
    higher rates of success, and in some cases, matching or
    exceeding success noted in human IVF today.
        Interestingly enough, and this is especially for the
    Congressman from Florida to listen, the Roslin Institute
    scientists who cloned Dolly the sheep and had so many problems
    with the sheep that they have cloned that they have changed
    their agenda today on the cloning subject and have stated
    recently that they plan to seek permission to experiment on
    cloned human embryos for medical purposes. What are their true
    motives? What are they?
        Animal Cloning vs Human Reproductive Regeneration. It has
    been very clearly shown that animal cloning and its
    difficulties appear to be species-specific. The data cannot be
    extrapolated with a great degree of accuracy to the human
    species. In a recent study by scientists from Duke University,
    it was demonstrated that it may be technically easier and safer
    to reproduce somatic cell nuclear transfers in humans than in
    sheep, cows, pigs, and mice because humans possess a genetic
    benefit that prevents fetal overgrowth, one of the major
    obstacles in cloning animals.
        The Political Status on Cloning. The political situation
    with cloning in general remains very fluid, Mr. Chairman, today
    mainly because of the inability of the politicians to
    understand, comprehend, and act decisively on the issues that
    cloning presents to society. After all, their inability to act
    decisively may have a great deal to do with their resistance to
    debate and face the facts that humans will be cloned.
        Recent statements by the President of the U.S.A., Mr.
    George Bush, in his speech to the American public President
    Bush made an appeal for a global ban on cloning, whether it may
    be for therapeutic or reproductive cloning, on the basis that
    we should not use people for spare parts and we should not
    manufacture people.
        Reproductive cloning, Mr. Chairman, does neither. Quoting
    President Bush, ``Life is a creation, not a commodity. Our
    children are gifts to be loved and protected, not products to
    be designed and manufactured. Allowing cloning would be taking
    a significant step toward a society in which human beings are
    grown for spare body parts and children are engineered to
    custom specifications, and that's not acceptable.''
        And that is not acceptable to us either, Mr. Chairman. We
    agree with President Bush on the sanctity of human life.
    Reproductive cloning does not involved a destruction of human
    embryos, nor does it modify or engineer the genetic code to
    custom modifications. Reproductive cloning is nothing more than
    another modality for the treatment of human infertility and
    giving the gift of life to childless couples that have
    exhausted all other choices for having a child. What is so
    wrong about that?
        History tends to repeat itself. This is not the first time
    that the scientific community has had to deal with
    controversial issues regarding new technologies. Exactly the
    same thing happened with IVF in the Kennedy Institute in
    Washington in 1978, when Professor Robert Edwards and Dr.
    Patrick Steptoe were faced with such criticism; 24 years later,
    the exact opposite of everything the experts predicted
    happened: IVF today is synonymous to sliced bread.
        In conclusion, Mr. Chairman, I would like to say the
    following. As Professor Robert Edwards, the great English
    scientist, who I have great respect for and who helped create
    the world's first test tube baby, Louise Brown, in 1978, so
    eloquently prophesied recently, saying the following,
    ``Cloning, too, will probably come to be accepted as a
    reproductive tool if it is carefully controlled.''
        It is your responsibility, Mr. Chairman, to control this,
    with the guidelines via which this can be developed, but it
    will be developed. Mr. Chairman, science has been very good to
    us, and we should not abandon it now. Consider why America has
    the best medical care in the world. It is because we have the
    freedom to investigate, research, and market the latest medical
    techniques, all within proper procedures and safeguards.
        This is not the time to panic and try to turn back the
    clock. The genie is already out of the bottle. Let us make sure
    it works for us, not against us. Let us do it right, and let us
    do it here. By banning cloning, America will be showing the
    world that she is hesitant and/or reluctant to take the lead in
    this new arena of technological advancement. The world today is
    looking at the most powerful Nation on Earth for leadership on
    this issue. And walking away from it, banning it, is not a sign
    of leadership but cowardice.
        Do not let the future of this technology slip away from our
    fingers because we are too afraid to embrace it. I believe that
    it is the right of the American people to choose whether or not
    they want to have this technology available to them. Let us
    educate ourselves and debate the issues, and not make
    irrational decisions based upon fear of a new technology.
        Banning this technology would not only give our enemies
    license to use it to their advantage, and that is really pretty
    much one of the important aspects of it, but let us learn from
    history, Mr. Chairman and forge ahead in this brave new world
    as leaders, not spectators. That is the American way. Thank you
    very much.
        Mr. Souder. Thank you.
        [The prepared statement of Mr. Zavos follows:]

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        Mr. Souder. I want to thank each of you for your testimony.
    Nobody can accuse us of not hearing all sides of debate in the
    first panel.
        I am next going to yield to the ranking member, Mr.
    Cummings, for his opening statement, and then we will move to
    questions.
        Mr. Cummings. Thank you, Mr. Chairman.
        Back in 1995, Congress passed legislation banning the use
    of Federal funds for human cloning research. Two years later,
    the birth of Dolly the sheep gave immediacy to the unsettling
    prospect of thinking, feeling, human clones also walking the
    Earth.
        In recent years, a vigorous debate has ensued over the
    medical and ethical implications of all aspects of human
    cloning research. Last July, that debate reached the floor of
    the House of Representatives. When all was said and done, the
    House had passed legislation that would render all human
    cloning research efforts a criminal enterprise, including those
    aimed not at reproduction but exploring the potential for new
    medical therapies and cures to human diseases and ailments.
        During the House debate, a substantial minority of Members,
    including myself, questioned whether closing the door to
    therapeutic or research cloning activity in the United States
    was timely or prudent. These concerns were expressed through
    support of a substitute amendment by Representative James
    Greenwood of Pennsylvania. That substitute amendment failed.
        The U.S. Senate is now about to embark on a similar debate
    in which the same central issue will be aired: should a ban on
    human cloning extend to therapeutic or reproductive cloning
    research?
        Dr. Zavos, we, too, take it very, very seriously. As a
    matter of fact, I think it is one of the most wrenching issues
    that we deal with in this Congress, because we have a debate,
    and on the one hand--and a lot of it is based upon religion--a
    lot of people feel you should not interfere with life. There
    are others who feel that we should try to address the issue and
    provide, I think as you are talking about, possible cures to
    diseases and trying to open up the door for research that might
    very well do a lot of good.
        It is a wrenching issue. In this very hearing room not very
    long ago, we had a couple who testified they had two young
    children who actually needed certain--or could have benefited
    possibly from certain research of this nature. And it was clear
    that they had very little likelihood of surviving without it.
    They, by the way, were testifying against cloning, and it was
    very interesting.
        On the other hand, we had some folks who felt very strongly
    that there was--they wanted to allow research to help other
    people. So this is a tough, tough issue. I do not want anyone
    here to go for 1 second thinking that we do not consider this
    matter to be a very, very serious matter.
        Those who support a ban on therapeutic cloning raise a
    variety of objections to this research, ranging from the
    morality of creating embryos for research purposes to the
    practicality of the research to whether a partial ban can
    effectively be enforced.
        There are, of course, counterarguments to each of these
    objections. Today we will hear from witnesses whose views cover
    the spectrum, as we have already heard, from support for
    reproductive cloning at one end to a categorical opposition to
    all human cloning research at the other.
        We will also hear testimony proposing some intermediate
    approaches not embodied in the current legislative proposals. I
    hope that the members of the subcommittee and Members of the
    Senate who may be paying attention will listen with an open
    mind.
        Ultimately, this debate is about whether Congress will
    close off an avenue of scientific research that some reputable
    scientists believe may offer immense benefits to millions of
    people in and beyond this country, ladies and gentlemen, people
    who are suffering and people who will suffer in the future from
    a range of life-threatening and severely debilitating diseases
    and ailments, including diabetes, Parkinson's Disease, and
    spinal cord injury, to name just a few. This we should not do
    rashly. I think the House did act rashly last July, and I hope
    therefore that today's hearing will serve the constructive
    purpose of establishing a more thorough record that will
    provide for a more informed and thoughtful debate in the
    Senate.
        To all our witnesses, we thank you. I have often said it is
    so pleasing to see so many young people in the room, because I
    have often said that our children are the living messages we
    send to a future we will never see. This is an issue that they
    will have to grapple with. We are grappling with it today, but
    they will grapple with it in future generations, so we have a
    duty to give it our very, very best thought, our very, very
    best research, and come to our very, very best conclusions.
    With that, I thank all of you for being here. Good day.
        Mr. Souder. Thank you.
        Just so you understand, this is being carried over our
    Government Reform channel, so that Members and their staff can
    see it in their offices, in addition to later on on C-Span and
    others. The House is in session, so it is not on regular C-Span
    right now.
        I would like to start the questioning with Dr. Zavos.
        Have you as yet produced a cloned human embryo?
        Mr. Zavos. I'm sorry?
        Mr. Souder. Have you as yet produced a cloned human embryo?
        Mr. Zavos. No, sir.
        Mr. Souder. Do you expect to be capable of impregnating a
    woman with a cloned human embryo in the future, the near
    future?
        Mr. Zavos. The answer to that is yes.
        Mr. Souder. The near future?
        Mr. Zavos. There is obviously very high speculation, as you
    may have read in the news recently, that there may be three
    women pregnant already with a cloned embryo. Therefore, there
    might be some children born soon via reproductive cloning, as
    my former associate, Severino Antinori from Rome, has stated
    recently.
        Mr. Souder. Are you saying you have women who are currently
    impregnated, or just your former colleague from Rome?
        Mr. Zavos. I have no cloned pregnancies to announce, and I
    have never produced a cloned embryo as yet.
        Mr. Souder. Do you expect to be able to do so in the near
    future?
        Mr. Zavos. Yes. Our team is ready to carry on the process,
    and we feel like we are quite confident that we can carry this
    successfully.
        Mr. Souder. Do you believe the reports from Rome are true?
        Mr. Zavos. I'm sorry, with those cameras here----
        Mr. Souder. Do you believe the reports from Rome are true?
        Mr. Zavos. I don't believe those reports from Rome, no.
    Obviously, I have my reasons for that, and you know, obviously,
    I may have been born elsewhere, outside the United States, but
    I am still from Missouri.
        Mr. Souder. The ``show me'' State, for those who may be too
    young to know that.
        Mr. Zavos. Yes.
        Mr. Souder. Would it be possible to distinguish between
    natural pregnancy and a clonal pregnancy, in your mind? In
    other words, how would the government be able to tell the
    difference?
        Mr. Zavos. No. To my knowledge, no. The only way,
    obviously, is to DNA-test the offspring and the DNA donor, if
    they concede to that, of course.
        Mr. Souder. So you believe if the bill passed that
    authorized reproductive cloning, there really would not be a
    functional way to tell the difference?
        Mr. Zavos. No, not really. After we create an embryo, after
    that embryo is cloned or sexually produced via IVF or whatever,
    they cannot be told apart. Therefore, you know, all this
    speculation that goes around that we are going to be able to
    supervise it and do this and do that reminds me of the 1940's,
    of the Germans, somewhere. I hope that America does not come to
    that.
        Mr. Souder. Dr. Usala, do you think the money spent on
    human cloning takes away research on more realistic and
    promising avenues for cures that could actually treat a large
    number of people? We have been having this debate in the halls
    of Congress and literally meeting in the hall. We have had this
    debate among a number of Members on the zero sum game. How do
    you think this plays out?
        Dr. Usala. I feel very strongly that it would detract. I
    feel very strongly that if cloning were allowed, there would be
    a landslide of funding from the NIH and other sources to only
    go that route. The reason is that my colleague, Dr. Cowan, was
    saying, talking about Galileo. Galileo was the odd man out. He
    was viewed as an extremist.
        The way funding really works in this country, those with
    original ideas do not participate in the funding from
    government sources.
        I was part of a private company that developed this
    technology. I didn't ask for NIH funding until I didn't need it
    anymore, and the reason for that is that researchers will go
    where the review committees will approve grants. If cloning, if
    human embryonic stem cell research is viewed as a promising
    area, whether or not it really is, academic scientists will be
    drawn to it.
        As an example, before 1992, the NIH and the American
    Diabetes Association said that there is no real evidence that
    type blood sugar control prevents complications in Type one
    diabetes. Well, we now know that wasn't true.
        I have had diabetes since I was 1 year of age, and I am
    currently 43. The children I grew up with with diabetes are all
    dead because the scientists that were very respected at the NIH
    and the American Diabetes Association said that no control
    doesn't make any difference, and as a result of that, research
    wasn't geared for developing therapies that could help keep
    blood sugars in the normal range.
        Now, again, I was viewed as an extremist for taking insulin
    shots before 10 years of age, but I am alive to tell you about
    this. But my point is that if we decide as a society that a
    therapy may be useful, and particularly if the Federal
    Government allows funding for it, all efforts seem to go in
    that direction. And it is only, ``the extremists,'' that take
    others.
        I have shown you preliminary data that was reviewed by the
    FDA, and I can assure you that FDA standards are far more
    stringent than just the peer review process of article
    publication. I was only interested in finding a cure of medical
    therapy for my patients; and as a result, I obtained funding
    from other sources.
        In summation, Mr. Chairman, I think that if we do allow
    cloning to occur, we will be going down a path that will
    require years of research on only speculation.
        Mr. Souder. Thank you.
        Mr. Cummings.
        Mr. Cummings. Doctor, as I listen to you, I just couldn't
    help but think that you were the one who fought sort of out of
    the box; is that right?
        Dr. Usala. Correct, sir.
        Mr. Cummings. And you would have been viewed as somebody
    who may have been a little radical; am I right?
        Dr. Usala. That's correct.
        Mr. Cummings. At 43, you are still here to tell us about
    it. And I'm just thinking, when I look at Dr. Zavos I think he
    would be looked at perhaps today as being a little radical. And
    as I listen to you, you almost make the argument for making
    sure that we do try to look at things outside the box. And help
    me with that.
        Dr. Usala. Well, I think that the Federal Government might
    not--it might not be the correct place for it to go down a path
    that seems to favor one form of therapy or another. Certainly
    we can't discuss the scientific validity of any of our
    approaches here. That would take days, weeks, months, years,
    and we still wouldn't come to a conclusion. But I think what we
    have to always remember is, is this consistent with our
    society?
        The problem I have with using cloning for research purposes
    is that a human life is destroyed, and it is as simple as that.
    And the paradox of creating life and then mandating by law that
    you have to destroy it to prevent what Dr. Zavos would like to
    do seems to me total contradictory to the fabric of American
    society.
        So that is my largest objection against the therapeutic
    cloning issue.
        Mr. Cummings. Thank you.
        Dr. Zavos, has the existing regulatory framework, namely
    the FDA, been the reason why you are pursuing cloning outside
    the United States; and will your plans change if a ban on
    cloning is made into law?
        Dr. Zavos. We don't have any intentions of changing our
    plans at this moment. I think we are not in the business of
    pitching tents anywhere that people sort of show us to do that.
    It is the responsible way, I think, for us as a team. We
    already have two places that we could be executing this
    particular type of research and this project. And, therefore,
    we are not interested, and we have decided that.
        And I testified before the Congress last year that we had
    decided from the beginning that America is not the best place
    to do this, the reason being that I think our society is the
    best society in the world to live in. But when it comes to
    subjects like that, we cannot get the Americans to agree on too
    many things. Therefore--there is a great deal of diversity in
    this country, and I don't think that we can unite the Americans
    on this issue. And I respect that. And we cannot afford to be
    disrupted by the politics and the so-called ``ethical'' and
    other rules and variables that are thrown at us.
        Obviously, we remain focused on this subject and that is to
    clone a human for reproductive purposes, because I think it is
    time for that to happen. And there is no way of turning back.
    There are five teams in this world that I know of that are
    doing this right now; and I think that we--and I happen to
    believe that, because I know the depth of our team, we're the
    best ones to do this.
        Mr. Cummings. Dr. Cowan, we seem to have some difference of
    opinion among the scientists here. It gets a little hard for us
    to sort out these things. You are all the experts and we have
    to rely on you, and you all are kind of saying different
    things.
        Should we give all of these perspectives equal weight?
        Dr. Cowan. In my opinion, the differences that you hear are
    based on both the extremes and the main frame of research work
    in the United States. And I think that you have to bring all of
    this information together to form the opinion, but in fact,
    pick the straightforward pathway of what the main contingency
    in the United States brings forward.
        The debate that emerges from the outside--no research, no
    cloning, all the way to cloning and research--allow us to fold
    this information together. And these debates are very
    important. It is certainly very important to hear this
    information, but I think that the main thrust of the
    information will come from the medical scientific community,
    yes, sir.
        Mr. Cummings. I know you don't have a crystal ball, but if
    you could, based upon what you hear and see today and the
    research you have done, what do you see in 20 years?
        Dr. Cowan. On this subject, we will be done with embryo
    cloning. That process will have brought us new technology, so
    we don't need to take an embryo and try to clone it. We will
    have developed substantial treatments for our patients. If this
    research is allowed to go forward, we'll have developed
    substantial treatments for our patients.
        Mr. Cummings. Thank you all very much.
        Mr. Souder. Dr. Weldon?
        Dr. Weldon. Thank you, Mr. Chairman.
        Dr. Cowan, you said in your testimony on page 2, human
    reproductive cloning would be wrong at this time--I am quoting
    you there--at this time.
        Dr. Cowan. That's correct.
        Dr. Weldon. On page 3 you said, ``Until there are better
    results in animals, we have no business even considering it in
    humans.''
        The gentleman to your left has no problem with trying with
    humans right now. Am I reading and understanding your testimony
    correctly to say that the society you represent feels that once
    the proper research is done and that this could be developed
    safely in humans, that your professional association would
    support reproductive cloning?
        Dr. Cowan. I do not know what the professional society will
    ultimately recommend. At the present time, however, we know
    only a small part of cloning from animal work, and that work
    tells us that it is not safe. We have no controls in place, and
    we do not recommend it for clinical care.
        Dr. Weldon. You are the president; is that right?
        Dr. Cowan. I am sorry?
        Dr. Weldon. You are the Director of the American Society of
    Reproductive Medicine.
        Dr. Cowan. No, sir, I am not. I am on the board of
    directors.
        Dr. Weldon. But you kind of leave the door open. That's the
    impression I get. You say, at this time, until there are better
    results in animals; I can't help but conclude that at least in
    your opinion and the position of many members of your
    professional association that you may come out ultimately in
    support of Dr. Zavos' position that we should allow
    reproductive cloning.
        Dr. Cowan. Yes, sir. It is a difficult position. Certainly,
    at this time though, we don't recommend it; but times can
    change. Times have changed for all of us, and we may very well
    see the position for reproductive cloning in the future. Rather
    than close this door, we would prefer to say, leave it open
    until we know more about it.
        Dr. Weldon. Would you not agree that this would raise some
    very serious ethical issues that extend far beyond the original
    debate associated with IVF, issues of paternity, who's the
    mother, who's the father, inheritance, legal issues, whole
    hosts of moral and ethical issues.
        Dr. Cowan. Yes, Dr. Weldon, I would.
        Dr. Weldon. You further made statements about tremendous
    potential for cures. You know, I am a physician, and I'm sure
    you're aware of that. I treat persons with diabetes and
    Parkinson's disease.
        I remember the great debate we had in this country back in
    the early 1990's about the so-called tremendous potential of
    fetal tissue research and all of the attempts at transplanting
    neuronal tissues to treat Parkinson's disease were a dismal
    failure. Why are you coming as a physician before this
    committee contending that there is great promise in this arena?
        I read the New England Journal of Medicine every month--it
    comes out every week; I read the JAMA every week. I haven't
    seen any articles that suggest that there is the great
    potential that you claim in your testimony.
        Where are you coming from on this? Are you doing research
    that we don't know about?
        Dr. Cowan. No, sir, I am not doing any stem cell research
    or somatic transfer research at all. But I do believe that this
    research is a very important tool for us to investigate and
    learn the answers to the questions that you're asking--will it
    help us treat these patients?
        If we fail, we fail, but it offers hope to our patients for
    the treatments of the diseases.
        Dr. Weldon. I want to interrupt you on that. You say it
    offers hope. In my opinion, it offers false hope because there
    are millions of people who listen to these debates and hear
    what people like you are saying, and they think this is around
    the corner.
        But I met with the--I think he is the president of the
    Research Division of the Juvenile Diabetes Foundation, a Dr.
    Goldstein, I think his name was. They have over $100 million
    budget. They're spending zero on cloning.
        You get the impression out there that there's all these
    great breakthroughs that are on the horizon when you say, we
    have to do this research. And, you know, what I'm saying to you
    is you could just as easily make the argument that you're
    creating blatant false hopes.
        And, you know--I was so intrigued by your testimony, Dr.
    Usala. I can't tell you how many diabetic ulcers I have
    treated. And the outcome of your kind of research is really
    fantastic. It is cutting edge, it's on the horizon. I assume
    you can use this product in other tissues; it is not limited to
    diabetic ulcers. You can do research in heart tissue and
    neuronal tissue to stimulate growth; is that correct?
        Dr. Usala. This particular product, Dr. Weldon, induces
    regeneration of mesenchymally derived tissues, deep skin, bone,
    cartilage and blood vessels. Again, I am just looking to how
    nature does it. Nature spent several hundred million years
    coming up with the template for how this works. I have
    currently formed another company, ECTOcell, trying to find a
    similar scaffolding that will induce ectodermally derived
    tissues.
        But the concept, I believe, is a valid one because we all
    know as scientists the chaperone proteins really modulate the
    expression of the DNA template. And those chaperone proteins
    are modulated by cytoplasma factors which are modulated by the
    external environment. During embryogenesis there are particular
    proteins that come into play naturally, and what I am trying to
    do is find artificial analogues of those to induce the same
    effect.
        In answer to your question, this, I believe--and we have--
    the company that I left has data to support that tissues
    derived from the mesodermal layer can be induced to regenerate
    with this material.
        Dr. Weldon. I know my time has expired with you, but could
    you explain to the people on this committee what you're talking
    about, ``mesoderm'' and ``ectoderm,'' because I know what
    you're talking about, but----
        Mr. Souder. I have no idea.
        Dr. Weldon. I yield back after he answers that question.
        Dr. Usala. There are three basic germ layers that evolve
    during embryogenesis, mesoderm which gives rise to kind of
    connective tissue structures, like blood vessels, bone,
    cartilage, deep skin, ectoderm, which gives rise to all of your
    neural tissue and the outer layer of skin; and endoderm, which
    gives rise primarily to the internal organs.
        And basically all these cells from the different germ
    layers, have the same DNA. Well, why is it that they
    differentiate into different things? And so what I try to do is
    to mimic what I thought was the structure that surrounded the
    different tissue layers, to tell those cells to become blood
    vessels, to tell those cells to become nerves.
        I think I hit it right with the mesodermal layer; at least
    in the feasibility trial, when I left, it--you could call Dr.
    Bill Morriston at the University of North Carolina. It was
    pretty spectacular stuff.
        And we don't have to go through the mental ``what if'' or
    we don't have to go through the--perhaps with enough funding,
    on a very limited budget, we were able to bring this to human
    clinical trials and achieve good results.
        Mr. Souder. Next we go to Congresswoman Davis of Virginia.
        Mrs. Jo Ann Davis of Virginia. Thank you, Mr. Chairman.
        And, gentlemen, I apologize. I wasn't here to hear your
    testimony, but I was chairing another committee.
        Dr. Zavos, I did come in in time to hear that I think you
    said: You haven't already impregnated a woman with a cloned
    embryo, but you would expect to in the future. Can you tell me
    when?
        Dr. Zavos. No. I can't answer that, obviously. We are doing
    this, but it's our plan and we obviously are not ready to
    release that. And when? Sometime in the future.
        Mrs. Jo Ann Davis of Virginia. I have had people in my
    office telling me that China has already cloned humans. Have
    you heard anything to that effect?
        Dr. Zavos. I am familiar with what the Chinese are doing,
    the Russians are doing, the Europeans are doing. I know of
    several teams that are making a great deal of progress on this
    issue, and their goal is to clone a human being; so there's
    obviously no shortcut on this one. And the Chinese will
    obviously be successful in probably--by passing us very
    significantly.
        And I wanted to refer to Congressman Weldon's comment in
    reference to, why are we keeping the doors open? There is a
    reason why we keep doors open, until we can see quite vividly
    that this technology is a total disaster or it holds a great
    deal of promise.
        My question is why are the British legislating in favor of
    therapeutic cloning? Why did the Australians just pass a law
    allowing that? And that is a very big issue.
        Mrs. Jo Ann Davis of Virginia. I don't mean to cut you off,
    but I have limited time, and I would like to ask some more
    questions.
        I am not sure who this would be for, but how many eggs have
    to be harvested to clone a human embryo?
        Dr. Zavos. We don't know that except to say that our
    experience with our team doing cloning in mice and cows have
    yielded a very high success in creating embryos via somatic
    cell nuclear transfer. The recent events at ACT, Advanced Cell
    Technology, they have attempted to--out of six anucleated
    embryo host sites they were able to do two human embryos, which
    is a 33 percent success rate in creating embryos.
        So this technology is developing very fast and it's
    developing by the day, not by----
        Mrs. Jo Ann Davis of Virginia. Thank you, Dr. Zavos. I want
    to go to Dr. Usala now.
        Why do you think the adult stem cell research has not
    gotten the attention that the embryo stem cells have? I mean,
    it seems to me that if we are going to set up a bank that you
    know someone could deposit the stem cells in, why does that not
    work or why are we not getting the attention there?
        Dr. Usala. I am not sure, Congresswoman Davis. It is
    speculation at best, and I would not be able to speculate for
    you.
        I think that those who have brought the human embryonic
    stem cell debate to our attention, even the people that really
    did the initial work on it, do not believe you can grow parts
    from it. What has happened is, I think this has been taken up
    by others who are more peripherally involved; and it seems just
    intuitively that if you take something at an earlier stage of
    development, you should be able to get it to do what you want.
    And I think that it's more complex than that, as we found out--
    the same issues as Dr. Weldon brought up.
        In the early 1990's they said, we can cure diabetes if we
    take fetal islets because they are less developed. They should
    be easier to take. And we don't hear about it anymore; it is a
    dismal failure.
        I believe the human--in the case of adult stem cells, it is
    not quite as intuitive that they would work, but in fact, they
    do. And in fact, the adult stem cells probably will work better
    because they are in the environment of the actual patient that
    they are trying to get to induce some tissue replacement with.
        So I think it's basically--and I think this is unfortunate
    to say, but I think it just has to do with the way it has been
    marketed. And, again, that is speculation.
        Mrs. Jo Ann Davis of Virginia. And, again, I am just still
    trying to learn about this, so if I am hearing you right then,
    adult stem cell has worked and embryonic stem cell has not
    worked?
        Dr. Usala. Human embryonic stem cells, to date, have not
    worked well. And in animal models they haven't worked--or some
    of them have worked in small animals; in large animals they
    really haven't. And there have been some very profound
    complications, including uncontrolled growth, cancer.
        With the adult stem cells we don't seem to see that.
        Mrs. Jo Ann Davis of Virginia. Thank you, Mr. Chairman.
        Thank you, gentlemen.
        Mr. Souder. Thank you.
        We have been joined by the distinguished gentleman from New
    York, Mr. Gilman.
        Mr. Gilman. Thank you very much. I regret I was delayed at
    another hearing.
        Let me ask the panelists, what is the benefit in scientific
    research of cloning? Do any of the panelists care to answer
    that?
        Dr. Cowan. I guess I'll take that one.
        And the question is, what is the benefit of therapeutic
    cloning?
        Mr. Gilman. For medical research.
        Dr. Cowan. Well, I can't specifically identify any
    particular disease. We have had some diseases discussed; spinal
    cord injury, Parkinson's disease, diabetes, these are diseases
    that are discussed.
        The issue for research to me, however, is the ability to
    probe the cells, probe the therapeutic modalities and develop
    understanding about the cell process, as well as therapeutic
    options for our patients. We all dream that we're going to do a
    therapeutic investigation, but most of these dreams actually do
    not come forward for us conducting medical research. Instead we
    learn just a small piece of that helps us go further and
    further down the road.
        I don't know if that is the answer to your question, but
    it's what we seem to understand today.
        Mr. Gilman. Do any of the other panelists wish to comment
    on that?
        Dr. Usala. I think that what cloning will do is provide
    perhaps hundreds of millions of dollars for NIH grants, for
    career development.
        I am not sure I agree with my colleague that oftentimes
    this does not relate in any therapy. On $6 million, I brought
    from animal trials into human clinical trials, FDA-monitored,
    done under the very strict FDA regulations of both product
    production, clinical protocol.
        I think that--well, it is like the movie, Animal House,
    knowledge is good. And I think sometimes the funding isn't
    really given for medical therapy, but rather as an end in and
    of itself. In my view, there really isn't any goal on the
    horizon of medical therapy. It really would just be interesting
    knowledge.
        Mr. Gilman. Does any other panelist care to comment?
        Dr. Zavos. There is no doubt that there is a great deal of
    potential, and we haven't really sort of touched this topic
    yet. I think we have a long way to go.
        And I think the evidence I can provide, Mr. Congressman, is
    the fact that governments such as England, Australia and others
    have already passed legislation regulating the exploitation of
    this technology, of this science. And there's obviously--are
    they smaller than we are? I don't think so. They are more
    opportunistic than we are.
        I think we are walking a very tight rope here calling
    ourselves ethically and morally better than they are, and we
    are going to pay a hefty price to buy that technology 10, 20
    years down the road. And we're making a big mistake.
        Mr. Gilman. Thank you very much.
        Thank you, Mr. Chairman.
        Mr. Souder. Before we move to the second panel, first let
    me thank each of you for taking the time to come here today. We
    will have additional written questions from some of us and some
    followup. This has been our second hearing. We're clearly
    intending to have a third as this issue continues to work. We
    have oversight of both the Department of Health and Human
    Services and the Justice Department.
        Dr. Zavos, we have asked you a couple of times, and I
    understand that this isn't the time or place where you want to
    release any particular announcement, do you have a rough
    timeframe? When I first asked you the question of when there
    might be a clonal pregnancy, you suggested that it would be
    sooner rather than later. Do you have a rough timeframe? Is
    that 3 months, 1 month?
        Dr. Zavos. My notion is that it will happen. A pregnancy
    can take place this year, 2002. A birth will be 2003. So all
    indication is that 2002 could be the year of the clones.
        Mr. Souder. Do you think that will be outside the United
    States?
        Dr. Zavos. Oh, definitely it will be outside the United
    States.
        Mr. Souder. I thank you for coming today and look forward
    to talking to you.
        If the second panel could now come forward.
        Each raise your right hands.
        [Witnesses sworn.]
        Mr. Souder. Let the record show that each of the witnesses
    responded in the affirmative.
        As you heard, we ask you to try to summarize your testimony
    within 5 minutes, and your full statement will be inserted into
    the record, as well as any other materials.
        Dr. James Kelly is a patient advocate, and activist
    probably, and we would appreciate you starting with your
    testimony.

    STATEMENTS OF JAMES KELLY, PATIENT ADVOCATE; ELIZABETH HOWARD,
      PATIENT ADVOCATE; AND JUDY NORSIGIAN, BOSTON WOMEN'S HEALTH
                            BOOK COLLECTIVE

        Mr. Kelly. Mr. Chairman, I just want to say for the record,
    I am not a doctor.
        Mr. Souder. We made you an honorary doctor today. Can you
    pull the mic a little closer? You are recognized for 5 minutes.
        Mr. Kelly. Five years ago----
        Mr. Souder. Your promotion got you so excited you got
    distracted there.
        Mr. Kelly. Five years ago, I had an auto accident and I
    became paralyzed with a spinal cord injury.
        And right off the bat, because I was a troubleshooter for
    19 years for the railroad industry and eventually a train
    dispatcher, I took Dr. Zavos' advice and I educated myself
    concerning what it was going to take to get me out of my
    condition to return my body. And I did this by spending
    literally thousands of hours a year reading PubMed and MEDLINE,
    medical journals, in speaking with the leading researchers in
    the country in neuroscience, to find out just exactly what it
    was going to take to cure spinal cord injury, because I wanted
    to support the researchers that were doing the kind of research
    that was going to lead to the cure that I needed.
        I didn't want to just support research, blank research or a
    blank check on research, because the way that you fix anything,
    whether it's the way Dr. Usala fixes people with diabetic foot
    ulcers or the way you fix a diesel locomotive, you do it by
    finding out what needs to be done and you take care of what has
    to be done.
        With that said, every year 26 million Americans are
    diagnosed with conditions that stem cells are expected to some
    day cure. Many more millions already suffer from these life
    threatening conditions or crippling conditions. Therefore, it
    is not farfetched to say, even a year's delay in the
    availability of cures for these conditions will result in
    millions of Americans needlessly suffering catastrophic
    impairment or enduring needless misery. Their loved ones will
    know profound sadness and grief.
        Americans are being told that cloning has the potential to
    play a large part in curing disease. Americans are believing
    what they are being told, and therefore they are speaking out
    in defense of their cures.
        But in my opinion, the question we should be asking
    ourselves is not, does cloning have therapeutic potential, but
    rather, will cloning--giving cloning research the green light
    speed the availability of medical cures, or will it slow or
    block their progress?
        After many months of investigation into the--sorry; I am
    jumping around and I'm losing my place--into the safety,
    performance and marketing potentials of embryonic stem cells,
    adult stem cells and cloned embryonic stem cells, I've arrived
    at a definite conclusion regarding the question that I think we
    should be asking; and I would like to present what I learned.
        I hope each of you will draw your own conclusions from this
    information and will speak up for your future where you have a
    chance; but please do so while considering the following points
    because this issues outcome will soon be a matter of life and
    death for millions. I want to emphasize that my only intention,
    or my only priority in getting involved in this investigation
    was that people with things like cancer, heart disease, spinal
    cord injury, Parkinson's, Alzheimer's, Rett disease will not
    have to suffer and die needlessly.
        I want the cures that everybody else wants. I want out of
    this wheelchair. I want Dr. Usala to be cured of Type 1
    diabetes. I want Dr. Usala's two children to be cured of Type 1
    diabetes. I want you to know what my priorities are.
        This is the information I learned about cloning. Embryonic
    stem cells taken from cloned embryos have safety and
    performance obstacles that need to be overcome before they can
    be medically tested in humans, including short- and long-term,
    genetically patience and reliability, a tendency to form tumors
    when injected into the host animals, and unexpectedly foreign
    tissue rejection. In other words, stem cells taken from cloned
    embryos, even though they have the patient's DNA, can still be
    rejected.
        The whole point is, it's supposed to not be rejected, but
    it will be rejected as a recent study in cell pointed out, and
    I will get to that later here if I have time.
        Another thing that is a problem with cloned embryonic stem
    cells is, they may offer questionable benefits regarding the
    potential to medical conditions with a genetic basis. In his
    March 5th testimony to the Senate, Dr. Stuart Newman of New
    York Medical College noted genetically matched cells from
    cloning may well be useless in treating conditions with a
    genetic basis, such as juvenile diabetes, for these cells will
    have the same genetic defect to cause the problem in the first
    place.
        Unfortunately, ma'am, I am sorry to say the same thing is
    true with Retts disease, because I want the same thing you
    want. I want your daughter cured. And I hope you understand the
    points I just said there. Do you?
        Cloned embryonic stem cells have yet to play a necessary
    part in treating any condition that improves a live animal or a
    human's medical condition. Cloned embryonic stem cells would
    require 15 million women's eggs to cure all diabetic Americans
    if attempting--if every attempt to clone was successful.
    However, most sources now claim that 100 attempts are needed to
    create a single cloned embryo able to yield usable stem cells,
    with each attempt needing another egg. Therefore 1.5 billion
    eggs would be required to use cloning for diabetic uses alone.
    Heart disease would require five to seven times more with 21
    million new cases of heart disease a year.
        There are a couple of quotes here I would like to quote of
    leading scientists who--where I got this information. Thomas
    Okarma is the chief executive of Geron Corp., a self-therapy
    company. He says he has no interest in using cloned embryos to
    produce customized treatments for disease. The odds favoring
    success ``are vanishingly small,'' he says. The costs are
    daunting. Okarma explains that it would take thousands of eggs
    on an assembly line to produce a custom therapy for a single
    person. ``the process is a nonstarter commercially,'' he says.
    In the previously--and that came out of an L.A. Times article.
        In the same article, Lutz Giebel, CEO of CyThera, a cell
    therapy company in San Diego, points out, ``Quality control
    presents another hurdle...the FDA can't regulate it'' and ``no
    one could afford the treatment.'' Giebel calls therapeutic
    cloning a research tool only.
        Also the embryonic stem cells are not expected by
    scientific supporters to have the potential for leading the
    medically available cures for a very long time. Scientist Janet
    Rowley is a pro-cloning member of the President's Council on
    Bioethics. In speaking of the therapeutic potential of cloned
    embryonic stem cells, she recently cautioned, ``I think it's
    not fair to say that the promise will not be realized, but I
    think it is fair to say that the promise may take a very long
    time.'' And I want to point out that we began our war on cancer
    with the notion it was going to be over in 10 to 20 years, and
    we are far from it.
        Mr. Souder. Mr. Kelly, we have let you go over some. We
    will insert into the record your information on adult stem
    cells, and if you would like to do a conclusion, then we'll
    draw more out.
        Mr. Kelly. What would you like me to do?
        Mr. Souder. If you want to just make a few concluding
    comments, then we'll ask you further questions, and we'll put
    into the record the adult stem cell material.
        Mr. Kelly. It was my fault. I am very sorry.
        My closing statement, what I would like to say is, I did
    not look at the ethical or the moral sides of this because my
    primary and my only concern was what was going to lead to cures
    faster, OK?
        After I came to the conclusion that banning cloning of
    humans was going to actually keep funds from being diverted
    from more promising avenues, I was then able to look at the
    moral and ethical issues involved, and I came to the conclusion
    that it actually is wrong to use human life at any stage for
    any purpose, especially if you are using that human life with
    the idea that you are going to destroy it.
        And what I would like to say finally is, most of us are
    instinctively horrified--what I want to say is, this is a very
    important--very, very important. This issue is going to
    determine the life and the quality of life and even the life
    and death of many millions of Americans. It is actually
    probably one of the most important issues
    that our Senate and our Congress has faced for very many years,
    and we need to get it right.
        We need to understand what is going on and we need to get
    it right.
        [The prepared statement of Mr. Kelly follows:]

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        Mr. Souder. We appreciate your passion, and it is personal
    and it is an addition for people you work with; and we
    appreciate that passion. Because often we can look at these
    things in a detached way, and it is important for us to see how
    you feel it and to see the impact on individuals, as well as
    for us to theoretically understand it. So I appreciate the
    emotion that you have brought to it in addition to the personal
    research that you have done.
        Thank you for your testimony.
        Ms. Howard.
        Ms. Howard. Good afternoon, chairman and members of the
    committee. It is good to see someone from my home State of
    Virginia here. Thank you for the opportunity to testify on the
    importance of somatic cell nuclear transfer, also known as
    therapeutic cloning or regenerative medicine.
        My name is Elizabeth Howard, and I am here on behalf of the
    Coalition for the Advancement of Medical Research. The
    Coalition consists of over 70 universities, scientific and
    academic societies, patient organizations and other groups that
    are dedicated to supporting and advancing stem cell research.
        Today, I know I am speaking for millions of Americans
    living with MS, spinal cord injuries, ALS, Parkinson's disease
    and many other less known illnesses that are equally as tragic,
    who may benefit from therapeutic cloning. I entered this debate
    from the patients' perspective. I do not profess to have a
    scientific or medical background, but I do have a background in
    watching suffering without the ability to help.
        Almost 3 years ago, I gave birth to a beautiful, healthy
    girl named Allison, and Allison is with me here today. My
    pregnancy and delivery were textbook perfect. Everything about
    Allison checked out fine and there was great joy in my family
    about this new life and its promise.
        Back then, in June 1999, I was oblivious that all expectant
    mothers are at risk of having a Rett syndrome daughter, that I
    might be one of those moms who had watched in horror as her
    happy, healthy baby girl did not develop properly and would
    lose a few acquired skills from which she derived joy and
    contact with the outside world.
        Rett syndrome strikes girls very early in their
    development, anywhere between the first 6 to 18 months of life.
    In 1999, it was discovered that Rett syndrome arises from a
    noninherited mutation in the MeCP2 gene on the X chromosome.
    MeCP2 plays an important role in brain growth and function.
    Because Allison's Rett syndrome onset was particularly early,
    she has never crawled, walked or talked.
        After undergoing numerous tests for over 2 years, involving
    many big needles, she began continuous compulsive hand-
    wringing, which is the hallmark of this syndrome. We finally
    had a diagnosis, but with this, learned that Allison might be
    trapped at the 6-month developmental level forever at best.
        Sadly, it is easier to point out the short list of
    abilities Allison does have than enumerate the long list of
    skills that she should have attained by now, but hasn't. She
    still manages to chew food with assistance. She can no longer
    use her hands. She can sit up very slouched, but still falls
    over. She has a contagious laugh and beams a wonderful smile.
        Finally, she makes excellent eye contact. It is with her
    penetrating blue eyes that Allison speaks to me, urging me to
    do everything I can to make her life less traumatic and more
    whole. She compels me to push me for advances in science, like
    SCNT, that hold promise to protect her from the many, many
    dreadful manifestations of Rett syndrome. These include
    seizures that can significantly set back development; breathing
    abnormalities that can be so intense the girls pass out; GI
    problems, which typically lead to feeding tubes; curvature of
    the spine, frequently resulting in complicated scoliosis
    surgery and/or dying suddenly while sleeping for no obvious or
    immediate reason.
        Despite all the important and vast advances in medical
    research over the last 20 to 30 years, there is still no cure
    or treatment for Rett syndrome.
        Let me state for the record that the Coalition for the
    Advancement of Medical Research supports efforts to prohibit
    human reproductive cloning. However, it is imperative that
    advancements in SCNT not be stifled or outlawed, since this may
    be one of the best avenues for ensuring that girls like Allison
    and the millions of Americans suffering from other disorders
    might some day live a more meaningful life and future
    generations of people afflicted by these disorders, perhaps our
    very own children and their children, might never have to
    endure what this current generation has suffered through.
        It is not my intent to exaggerate the promise or timing of
    SCNT research, but how can I look into my daughter's sparkling
    blue eyes and not assure her that scientists and lawmakers are
    embarking upon an area of research supported by 40 scientific
    Nobel Laureates that might allow her to have a happier ending.
        During the first panel, the American Society for
    Reproductive Medicine spoke to the science involved in the SCNT
    process. So in the interest of time, I won't explain it again.
    But let me just reiterate there is a critical distinction
    between the use of cloning technology to create a baby, which
    is reproductive cloning, and therapeutic cloning techniques
    central to the production of breakthrough medicines,
    diagnostics and potential vaccines to treat various diseases.
        Due to its promise to enhance the quality of life of both
    the young and the old suffering from various devastating, often
    life-threatening, disorders, how can we not allow this research
    to advance? The present momentum in biomedical research and the
    profound implications of what we are learning will inevitably
    raise public concerns. Yet an across-the-board ban on all types
    of human cloning would significantly set back advances in
    research that offer hope for Rett syndrome girls and the
    numerous Americans struggling on a daily basis just to make it
    past another uncontrollable seizure or tremor, to breathe
    without pain, to use their eyes as the onset of blindness
    occurs, and to continue walking before the amputation of their
    legs is required.
        On behalf of the Coalition for the Advancement of Medical
    Research and the countless Americans who stand to benefit from
    therapeutic cloning and the family members and friends who love
    them, I again thank the committee for its deliberations and for
    the opportunity to speak on this issue.
        Mr. Souder. We thank you for your testimony.
        [The prepared statement of Ms. Howard follows:]

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        Mr. Souder. Ms. Norsigian.
        Ms. Norsigian. Thank you, Mr. Chairman, and others on the
    committee. I am Judy Norsigian, the Executive Director of the
    Boston Women's Health Book Collective, and coauthor of ``Our
    Bodies, Ourselves,'' now in its 7 edition. There are now 4.5
    million copies in print in over 20 editions around the world
    with seven more on the way. It is the book that is the mainstay
    of the global women's health movement.
        First, I want to note that we do support embryo stem cell
    research that utilizes not only existing cell lines, but also
    embryos originally produced for use in IVF clinics. At the same
    time, along with other women's health and reproductive rights
    advocates, we have raised serious concerns about the wisdom of
    allowing embryo cloning, even for research purposes, at this
    point in time.
        We also believe, after a number of conversations with
    knowledgeable scientists, that today's most pressing challenges
    in the field of embryo stem cell research do not require access
    to embryo cloning. Despite much media hype to the contrary,
    there really have not been compelling arguments to allow embryo
    cloning now, especially in light of the serious and profound
    consequences of developing this particular technology.
        I have attached earlier Senate testimony that addresses a
    number of our concerns.
        But today I would like to underscore just two of the
    reasons that warrant a far more cautious approach than that
    adopted by the Sector/Kennedy/Feinstein/Hatch bill, permitting
    embryo cloning for research purposes, and the Dorgan/Johnson
    bill which does not even totally ban implantation of a clonal
    embryo. Most importantly, neither bill would adequately protect
    the women who would be donating eggs for somatic cell nuclear
    transfer.
        First, embryo cloning is a key element in the development
    of germline genetic modifications including modifications that
    go far beyond the realm of curing diseases into the world of
    so-called ``designer babies.'' The matter of germline
    modification, selecting for traits that would be passed on to
    future generations, is a separate discussion from human
    reproductive cloning and must take place before embryo cloning
    is allowed to go forward, and be refined in an environment with
    completely inadequate regulation of human germline genetic
    modification.
        Second, there are substantial risks to women's health posed
    by Lupron, the most common drug used to hyperstimulate the
    ovaries in the process of gathering eggs for somatic cell
    nuclear transfer. And unlike situations where individual women
    might benefit directly from using this drug, as could be the
    case when undergoing IVF or in treating endometriosis or in
    treating anemia-associated fibroids, women who take this drug
    solely for the purpose of providing eggs for research do not
    benefit personally.
        At this point, it is not clear they would be benefiting
    relatives or loved ones either.
        As of the spring of 1999, the FDA, the Food and Drug
    Administration, had received 4,228 reports of adverse drug
    effects from women using Lupron. Interestingly, they also
    received 2,943 such reports from men who used the drug in
    prostate cancer treatment; and despite the differences in age,
    sex and indication for use, the complaints were remarkably
    similar. 325 adverse events reported for women resulted in
    hospitalization, and additionally, 25 deaths were reported.
    Whether these deaths are directly attributable to Lupron
    remains to be determined, and I have recently asked FDA staff
    to look into this more carefully.
        Although the FDA cannot now provide more detailed data on
    adverse reports for women over the past 3 years--and there have
    been thousands--nor data on how many of these problems were
    long-lasting, rather than transient, FDA staff have indicated
    they will be reviewing these data in the near future. Our
    office, meanwhile, has received numerous complaints over the
    past decade from women who have had persistent joint pain,
    headaches and other serious problems many months and even years
    after their last Lupron shot. I am attaching a list of problems
    that have been reported to the FDA and in the medical
    literature.
        By the way, given our current problems with under-resourced
    and inadequate IRBs, we cannot now expect most IRBs to protect
    the women who would be providing eggs for research purposes.
    Once the FDA has completed its analysis of the many additional
    adverse reports on this drug, we will certainly have a more
    complete picture of the risks than we do now. But until such a
    time when more reassuring data might become available, or
    different drugs developed with a better safety profile have a
    longer track record, it is unethical to move forward with
    somatic cell nuclear transfer.
        Parenthetically, I do want to note that scientists in Italy
    and possibly elsewhere claim to have already perfected
    techniques for freezing eggs, something I have been told has
    not yet been done with success in this country. If unused,
    frozen eggs harvested initially for the purposes of IVF were to
    become available for subsequent somatic cell nuclear transfer,
    then of course you would not be exposing those same women to
    risks for the purpose of research only.
        Just at the practical level, it makes little sense to
    pursue clone cures for the diseases most often mentioned in
    media reports. Parkinson's and Alzheimer's diseases alone
    affect 5 million American and would require, minimally, 250
    million eggs to produce individualized therapy that would match
    the patient's own genome. This figure of 250 million assumes
    that at least 50 eggs would be needed per patient. And since,
    on average, about 10 viable eggs are likely to be collected
    from each individual woman who is a donor, 25 million women
    would be needed as donors, about half of all women of
    reproductive age, and that is just for these two diseases.
        The specter of such massive use of ovarian
    hyperstimulation, coupled with laparoscopic surgery, makes no
    sense, especially when other fruitful and less problematic
    approaches to developing therapies are already under way.
        In closing, I would like to note recent articles by
    Professor George Annas of the Boston University School of
    Public Health in both the Boston Globe April 21 and the New
    England Journal of Medicine last week. Professor Annas is not
    opposed to research cloning, but he does recommend that three
    features are essential to any bill that would effectively
    prevent human reproductive cloning: first, a prohibition on the
    stockpiling of embryos by outlawing the freezing and storage of
    research embryos; two, a prohibition on the purchase and sale
    of human eggs or embryos; and three, disqualifying of, ``anyone
    who is involved in activities related to in vitro fertilization
    or other infertility treatments'' from doing research with
    cloned embryos.
        These three elements are absent from all bills I mentioned
    earlier that permit embryo cloning for research purposes, and
    it would seem that their inclusion would have been an obvious
    thing to do to minimize the likelihood of human reproductive
    cloning.
        Professor Annas also notes that a compromise position which
    calls for a moratorium on embryo research cloning could also
    make it possible to pass legislation that would ban human
    reproductive cloning. Last June, a statement on cloning, signed
    by over 100 individuals and organizations and posted at our Web
    site, has called for such a moratorium on the use of cloning to
    create human embryos for research purposes.
        We recognize that no current legislative proposals embody
    this position, but we do believe that it still remains the best
    public policy. And during such a moratorium the FDA could more
    completely analyze the problems with drugs used for ovarian
    hyperstimulation, and the public could have a more thorough
    discussion of the scientific, regulatory and ethical issues at
    stake. This moratorium would be prudent and reasonable policy
    when faced with a technology of such profound consequence.
        Thank you very much.
        [The prepared statement of Ms. Norsegian follows:]

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        [GRAPHIC] [TIFF OMITTED] T6435.046

        Mr. Souder. I want to thank each of you.
        And once again we have a very diverse panel with different
    approaches to this same concern, which is how best to help
    people in this country.
        Let me ask Ms. Norsigian, would it be--without the last
    three restrictions you have, in other words, one of the things
    that is likely to happen if, in fact, that many women were
    needed, much like other things, even blood donation, wouldn't
    this likely also skew to those who are low income as far as
    donors and often younger people who are needing money?
        Ms. Norsigian. Absolutely. There is actually quite a bit of
    literature on this issue of excessive incentives and in
    situations of poverty. We have got worldwide examples where
    women have been exposed to unacceptable research risks or
    treatment risks because of the incentives that were offered.
        There would be an incentive. Mostly low-income women, women
    of color, would probably be candidates. But I think when you
    are looking at creating public policy of this sort, I think the
    safety issues are the paramount issues. And the other ethical
    issues, this would be a problem.
        But there are other examples where we have passed
    legislation, where we have public policy that lends itself to
    this. Already, when we look at the situation where women
    provide eggs for women who are undergoing IVF procedures, young
    women, coeds across the country are being paid $5,000 on up for
    providing eggs for IVF clinics.
        Some argue those are inappropriate incentives. Others say
    they are not inappropriate. But in those situations, you can
    definitely say there is a potential for benefiting somebody.
        In the case of research cloning, the individual women who
    are going to provide the eggs do not have any conceivable
    chance right now of benefiting someone. It is a very distant
    prospect of cures given the state of research we have right
    now.
        Mr. Souder. What is the potential scale?
        Ms. Norsigian. The scale would be enormous, that is true.
    Of course, there are scientists who are saying ultimately we
    would do away with cloning. We, of course, would develop better
    approaches. From a business point of view it doesn't make
    sense.
        But I do not think we justify a path from here to there
    that is littered with the bodies of women who have been
    damaged, whose health has been seriously damaged because we
    think there may be an end point that we cannot guarantee,
    especially when we have other avenues that, as people today
    have pointed out, seem to be much more promising.
        Mr. Souder. Thank you.
        Mr. Kelly, we have asked this a couple of different times,
    and it was suggested in the first panel, as well as our last
    hearing; and certainly in debate of when we spend the money on
    human cloning, does that take money from research from more
    realistic and promising avenues for cures that actually help
    people with different disabilities such as your own, or
    different diseases.
        Could you elaborate on what you've learned from some of
    your research?
        Mr. Kelly. Thank you for asking me that. I can definitely
    elaborate on that.
        I want to say something right off the bat, OK, if any
    money--if any money at all is spent on cloning, it will
    definitely take away money from avenues that could lead to
    cures for my condition. I can say that without a doubt. And the
    reason why I can say that is because cloning doesn't offer
    anything for my condition, all right?
        People with spinal cord injury--Christopher Reeve, for
    example, they are being led to believe that cloning is going to
    cure them. Cloning is not going to cure a spinal cord injury,
    because they don't know what it takes to cure a spinal cord
    injury.
        What cloning offers is specialized cell replacement,
    neurons and oligodendrocytes. Oligodendrocytes are the cells in
    the central nervous system that remyelinate the central nervous
    system axons or the nerves in the central nervous system.
        Christopher Reeve testified to the Senate that he needs
    remyelination in order to be cured. He told the Senate that
    embryonic stem cells are the only way you can do that.
        That is not true. There are four adult cell types that
    remyelinate the central nervous system. Two of them are in
    clinical trial. One is in a clinical trial at Yale; and the
    other is going to clinical trial at the NIH, and it's called
    bone marrow stem cells.
        But remyelination is not the main obstacle to curing spinal
    cord injury. The main obstacle is getting nerves to grow across
    the injury site. That has nothing to do with specialized cell
    replacement. Neurons won't grow across the injury site.
    Oligodendrocytes won't grow across it.
        There are dozens of avenues that are being developed to try
    to get nerves to grow across that lesion. It is called a
    lesion, and is what's called a gleal scar, and the gleal scar
    is very inhibitory to nerve regeneration. And cloning in any
    way cannot help get nerves to go across that lesion. And any
    money that goes to cloning will definitely impede the progress
    of research for spinal cord cures.
        Now, just to finalize this, the leading researcher in the
    United States has, per Time Magazine--his name is Wise Young;
    he is the neuroscience director of Rutgers University, and by
    the way, he is in favor of anything the NIH is in favor of. He
    is in favor of cloning because he is in favor of research for
    the sake of research, I believe--in my opinion.
        But he did say on his on-line forum to the SCI community--
    when asked, what are the prime motivations of researchers, what
    motivates scientists and researchers, he said, Most scientists
    that I know of work for recognition by other scientists; we
    have been trained this way.
        Funding is, of course, important to scientists. Many
    scientists will go to great lengths to get funding from the NIH
    and other organizations, including changing their experiments
    and even changing their fields to get funding. The NIH has
    great influence over science in the United States for this
    reason.
        What many people do not understand is, the NIH runs mostly
    through peer review, i.e., scientists who decide which
    applications have sufficient scientific merit to be funded.
    Only 20 percent of the grants are funded. Therefore, the
    competition is fierce and publications are important to decide
    funding. Therefore, if scientists around the United States and
    researchers around the United States decide the best way to get
    funded by the NIH is to fund what they think the NIH wants to
    fund, they will change their research to do it.
        You could have somebody that works on adult stem cells,
    which are right now very close to clinical trials for many
    conditions; and if they think--if they turn in a couple grant
    applications and they get turned down for whatever reason, they
    think they might be able to get it approved by submitting grant
    applications for cloning, Dr. Young is saying that they will do
    it.
        And I know that they will do it. I know it because Dr.
    Young, in 1985, wrote a letter to the FDA--and I have it here
    also. And in this letter to the FDA, he told the FDA that he
    was working on an avenue for my condition, spinal cord injury,
    that resulted in 78 percent of the treated animals being able
    to walk independently 4 months after having their spinal cords
    severely crushed. And he pointed out in his letter to the FDA
    that this was better than anything he had ever seen in his lab,
    including methylprednisolone and maxillim, which he pointed out
    was in a multicenter clinical trial by the NIH.
        Two months after submitting this letter to the FDA, he
    abandoned this line of research, which he had been working on
    for 7 years, because the NIH would not fund it. And he took
    over the methylprednisolone national clinical trial that the
    NIH was conducting. And he conducted that clinical trial for 12
    years, all right?
        The NIH looked into methylprednisolone and that is what
    they backed for 12 years. And Dr. Young admits that he had a
    more promising research avenue that was not funded by the NIH
    and was abandoned because it was not funded by the NIH.
        And now in the year 2000, here we are in the year 2000,
    these scientists publish and they say that the national acute
    spinal cord injury studies, 2 and 3, which were the NIH
    clinical trials, often cite as evidence that high dose
    methylprednisolone is an efficacious intervention in the
    management of acute spinal cord injury.
        Neither of these studies convincingly demonstrates the
    benefits of steroid. There are concerns about the statistical
    analysis randomization and clinical end points. Even if the
    punitive gains are statistically valid, the clinical benefits
    are questionable. Furthermore, the benefits of this innovation
    may not warrant the possible risk.
        The point is, there are other studies that back this up,
    and I cited them in my presented paper. The point is, the NIH
    turned its back on promising research in the past that
    scientists had compelling evidence was better than what the NIH
    was backing. And what they did in doing that was they spent 12
    years on this other avenue methylprednisolone that scientists
    now say not only does not improve the condition of people with
    spinal cord injury, but it causes more damage.
        Now what is going to happen--I am telling you this with
    total certainty of everything that I have put in my paper--I am
    sorry I am such a poor speaker. What's going to happen is what
    happened in 1985 that probably led to as many as half of the
    people paralyzed today being unnecessarily paralyzed. And now
    what is going to happen in cloning, history is going to repeat
    itself, but it's not going to be 300,000 Americans that are
    going to be affected, it is going to be 100 million Americans.
        Mr. Souder. Well, thank you for that. I am going to yield
    to Dr. Weldon in just a minute, but let me reinforce from our
    end what you have shown in your studies. I know from being in
    the legislative end--first as a staffer, now as a Member of
    Congress--and also with friends in different agencies that we
    get what we ask for.
        We get what we ask for. I work not in the health field so
    much but in the education area; and when we say we want this
    kind of research and we put that in legislation or when
    somebody in the department does it or, as in one case in one
    bill where a Member had gone to a conference and thought this
    education idea sounded good so it got written in a bill and
    then the research dollars were diverted to that form of
    education based on one Member having gone to a conference, that
    is how the research dollars get driven, from our end.
        What you have done is put it in the reverse. In other
    words, you said here you saw it, that the researchers will
    respond to where the money flows and that the policies that
    seem to be asked for out of Congress or are media-driven may
    not be based on science.
        There has been this false dichotomy today that implies that
    this is a scientific decision that is being made, and I don't
    believe it is. This is our second hearing, and we have yet to
    hear, after 20-some years of research in embryonic stem cell
    research and other things, of anyone seeing any information
    where we have other promising results. In fact, in talking with
    a number of my colleagues who favor this type of research, they
    admit they do not have it.
        We are trying to look for a less politically charged way,
    because they are acknowledging the potential diversion of huge
    amounts of dollars from things that in fact are working.
        This is not science versus nonscience. It is ridiculous to
    compare it to Galileo about the flat earth, for crying out
    loud. This is science versus science and where do we put the
    dollars to most effectively help people like yourself and your
    daughter and that we are getting caught up in, roughly, name-
    calling about how best to do this.
        I believe ethics are a key variable to this, but
    particularly when the ethics is debatable, the science is
    screaming out that there is research on one side, it is
    baffling to me why we continue to debate this when there is no
    hope but a false hope. I have not heard anything specific other
    than that.
        Mr. Kelly. Sir, unbelievably, what I am finding, without a
    doubt, is it is not science versus science, it is science
    versus cures, OK? There is definitely science out there that
    offers hope for cures. There definitely is. But cloning is not
    that science.
        It does not offer it for several reasons. Not only does it
    have huge technical obstacles that are going to take decades to
    overcome, and the scientists I have quoted in my paper--I am
    not just pulling these numbers off the top of my head, but it
    is going to take decades to overcome them, if they can be
    overcome. And they even say that, that they are not even sure
    they can be.
        But, on top of that, the cost of overcoming these obstacles
    and the cost of the treatment itself is going to be so
    astronomically high.
        James Thomson--that's where I got that number--is the
    father of embryonic stem cells. He admits that the cost of many
    types of therapies that could come from cloning could be
    astronomically high. Nobody could afford it. And if you cannot
    afford it, where are people getting the word therapeutic for
    cloning if there is not going to be any therapy? If I cannot
    afford it, the government cannot afford it and the insurance
    companies cannot afford it, who is going to afford it? It is
    not going to happen.
        We are being used. We are being misled. We are--and when I
    say ``we,'' I mean the disabled communities--we are slitting
    our own throats by trying to back cloning, and we are doing it
    out of desperation.
        Mr. Souder. Thank you very much.
        Dr. Weldon.
        Dr. Weldon. Thank you, Mr. Chairman.
        I want to thank all of our witnesses and Ms. Norsigian in
    particular. Your testimony was excellent and to the point.
        I got the impression that you would like to see a
    moratorium, but there are no moratoriums currently being
    debated in the Senate. As you know, we passed a ban in the
    House. Understanding that, the political reality, of the two
    bills to come out of the Senate, which one would you prefer,
    the Brownback-Landrieu version or the Kennedy-Feinstein version
    of the bill? Which would be better for women's rights, would
    you say?
        Ms. Norsigian. If I had to choose, I would choose the
    Brownback-Landrieu, because I know if the evidence were to
    emerge that would convince me that this was a promising line of
    research, we could revisit the issue.
        I know the bill asks for a revisitation of the issue, and
    new scientific progress or discoveries could be considered, and
    the ban could be overturned. In the meantime, women would be
    protected.
        I want to caution everybody who might go to an IVF clinic
    and be told that Lupron is perfectly safe or that it is fine
    and we do not have problems, it is a bit of a sleeping giant
    here. I want to use an analogy.
        Some of you remember what happened with genetically
    engineered insulin. You know that it finally caused the animal-
    based insulin to be taken off the market, and those who were
    forced to use the genetically engineered insulin had some
    serious problems. There is a Canadian woman named Colleen
    Fuller who went into a coma several times. She is not the only
    one. Many, many people did.
        It took a long time before physicians and the government
    recognized that there really was a problem associated with
    genetically engineered insulin, and it took the people who
    suffered quite a long time to have this recognized. In the end,
    animal-based insulin came back on the market, so those people
    who could not use the genetically engineered insulin had
    another choice.
        This is not dissimilar in that we have many women--they
    have formed the Lupron Victims Network. Many of them have been
    sharing information on the Internet. I have talked to several
    people who work at IVF clinics who have seen these problems.
    But, in some cases, the women do not go back to the clinics
    because they have had such a bad experience with Lupron they do
    not trust the physician who gave it to them to begin with, so
    physicians do not see those women again.
        Dr. Weldon. Let me make sure I understand you clearly,
    though.
        Ms. Norsigian. What I am saying is there is a need to
    protect women from what I think right now are fairly
    substantial risks, and the FDA has yet to do the job we want it
    to do. That is such a great need that we need to take the
    legislative route that will not allow somatic cell nuclear
    transfer now for research purposes.
        Dr. Weldon. Your position, though, is you support the use
    of Lupron in the setting where a woman wants to become
    pregnant, wants to go through the IVF process and has been
    properly counseled on the potential side effects of Lupron? You
    are opposed to the potential wide-scale large numbers of women
    who would be exposed to this drug in the setting of somatic
    cell nuclear transfer?
        Ms. Norsigian. ``Support'' is maybe too strong a term. I
    wish we had better safety data on this particular drug before
    it became in widespread use. It is in widespread use. The cat
    is out of the bag.
        I do not agree with Dr. Zavos that cloning human beings is
    absolutely inevitable, it is just going to come, and we should
    just learn to accept it. This is a case where there might be
    better drugs. We might develop them.
        I am not so sure that I am happy about the way Lupron has
    been used for off-label use. It has never been approved for
    this purpose in IVF clinics. I am not happy about this, but I
    am happy for the many women, some of whom are my good friends,
    were able to use IVF to become mothers. So for those women, and
    they are a minority, but for those women who were successful,
    even knowing there were more risks than they were told, they
    would have taken those risks to have a baby.
        It is a very different risk-benefit ratio from a research
    setting where providing eggs for research cloning would have
    nothing to do with the opportunity of becoming a mother or
    treating a disease.
        Dr. Weldon. Just for the record, and I know we have
    discussed this privately, you do come at this cloning issue
    from a pro-choice perspective? You support abortion rights, is
    that correct?
        Ms. Norsigian. Absolutely. I did not even think I had to
    say that because Our Bodies, Ourselves is so well-known. We
    have been strong reproductive rights advocates for many, many
    years. But we also believe in having a strong FDA and having a
    strong system of regulation. We are very concerned about the
    inability of IRBs to monitor research protocols adequately.
        I also serve on the board of directors of Public
    Responsibility in Medicine and Research, which is doing a fair
    amount if not most of the training of IRB members in the
    country. So I am deeply concerned with research issues.
        I support research, and I want to say that I come from that
    position, but that it is not to be construed as accepting any
    and all research simply because it can be done.
        Dr. Weldon. I thank the gentlewoman.
        If the chairman could just indulge me for a little longer,
    Ms. Howard--and by the way, I am very sympathetic to the
    problem that you are facing with your daughter. I have had the
    opportunity to take care of some patients with Rett's disease,
    and I understand fully the challenge that you face.
        Have you been led specifically to believe that there are
    researchers who have clinical applications of cloning
    technology specifically designed for the use in Rett syndrome,
    or are you just taking the position that you want to see all
    kinds of research go forward that might have a potential?
        I am just curious. As a physician, I have never seen
    anything across my desk on a clinical application of cloning
    methods in Rett's, specifically.
        Ms. Howard. Thanks for the question.
        Let me say this, that after about a 20-year search, the
    Rett gene was finally found only 2 years ago, so there is a lot
    still unknown about Rett syndrome. Cystic fibrosis is a gene
    that I understand is a gene that was discovered in 1989, and
    therefore people in that field have had a much longer period to
    investigate how that gene works, unlike Rett syndrome, which
    actually was discovered after my daughter was born, in fact.
        So my role as I see it in this debate is, since there is
    still so little known about how that gene works, what the
    remedies for Rett syndrome could ultimately be, I believe
    strongly that this avenue should be kept open. Because at the
    end of the day, it might best----
        Dr. Weldon. But you have not seen any evidence----
        Ms. Howard. I have not. I have not seen any evidence that
    any other pharmaceutical products could ultimately help, that
    any other--even knowing we are in the 21st century and medical
    science has advanced significantly, there is really nothing
    that can help Rett syndrome.
        So I want this avenue kept open, since this may be
    ultimately the best avenue. I do not know that for certain.
        Dr. Weldon. Just from a clinical perspective, I would argue
    that cloning is extremely unlikely to ever be beneficial to
    your daughter, but gene therapy would have the potential to
    help the victims of Rett syndrome. I don't want to burden the
    committee hearing with a lengthy scientific discussion of that.
        Now, you are representing the Coalition for the Advancement
    of Medical Research, correct?
        Ms. Howard. Yes.
        Dr. Weldon. Their basic position is that they want to see
    this move forward just because it might have some potential,
    but they do not have any knowledge that it has any specific
    applications in any of the conditions they are concerned about,
    correct?
        Ms. Howard. Correct. Let me speak to that.
        First off, let me just say generally that I recognize that
    we are at a very new juncture in terms of science and that this
    is inevitably going to raise a lot of questions, all of which
    are good ones.
        But, yes, indeed, the true application of therapeutic
    cloning has not fully been realized. But 40 Nobel Laureates
    believe it holds a lot of promise.
        Let me also mention this point, that I know there is
    discussion in the Senate about potentially just putting a
    temporary ban on therapeutic cloning while we investigate
    further what its real promise is. But what you do then is take
    a significant amount of momentum out of the focus on
    therapeutic cloning now, and even a 1-year ban or a 2-year ban
    could sap resources out of biomedical research companies, could
    make scientists go overseas.
        So if one does want to realize the ultimate potential of
    therapeutic cloning, stopping it even for a year or two would
    set back significantly ever finding out the potential of
    therapeutic cloning.
        I will not ever profess to have been or I do not think this
    is ultimately the cure. I am just looking for some potential to
    help my daughter and other people that are suffering.
        Dr. Weldon. I could go on and on, but I see my time has
    well expired.
        I just want to mention for the record, Mr. Chairman, the 40
    Nobel Laureates who signed the letter, 31 of them signed a
    letter 1 year ago stating that they would oppose or they would
    only support embryo stem cell on excess embryos from fertility
    clinics, 31 of the 40, and that they would oppose creating
    embryos for this type of research, and 31 of these 40 in 12
    months have changed their position and now support the creation
    of embryos for this kind of research, I think just essentially
    making the case that this is a tremendous slippery slope.
        I yield back. Thank you, Mr. Chairman.
        Mr. Souder. Mr. Cummings.
        Mr. Cummings. Thank you very much. I apologize for being
    out of the room. We have another hearing going on at the same
    time. I apologize.
        Ms. Howard, what do you say to those who argue that cloning
    embryos is immoral?
        Ms. Howard. First off, it is important to look at the
    difference between reproductive and therapeutic cloning. I
    think the differences between the two have been lost in the
    debate.
        Also, as I understand it, some of this original debate
    arose out of knowing that there were embryos at fertility
    clinics that were not being used and, instead of just throwing
    them away in the trash bin, actually using them because they
    held some promise--again, promise. I understand that I am not
    saying that there is a solution, that therapeutic cloning is
    going to cure my daughter a year from now. I don't ever want to
    make that statement falsely.
        Mr. Cummings. But there is a possibility. You are looking
    at the possibility, I take it.
        We have had extensive testimony on what you just talked
    about, the embryos that would normally be discarded. But go
    ahead.
        Ms. Howard. OK. And then the idea, again, is to use an
    unfertilized egg and take the nucleus out and mix it with the
    person who has troubles, including my daughter--with their own
    DNA, mixing them together. I do think it is important to
    emphasize again that it is an unfertilized egg we are
    discussing.
        Mr. Cummings. Do you think there is a moral problem?
        Let us deal with the therapeutic. You know, you have this
    group of people who are very, very emphatic about the fact that
    you should not mess with life. They do not care whether it is
    therapeutic or otherwise--or reproductive.
        I was just wondering, before your daughter--or before you
    knew about your daughter's illness, did you have a position and
    has your position changed as a result of that?
        Ms. Howard. My position has not changed at all. Even before
    Allison was born--and I think sometimes the point on pro-life
    is lost on people. I am pro quality of life for those who
    actually are alive now, and that is the extent to which I would
    extend my so-called pro-life position, is enhancing the quality
    of life of those who are suffering.
        My daughter has the potential in the next year to 5 years
    of dying suddenly, and that is why I take this moral position
    to work with her and hope that there are treatments for her,
    including potentially this one, that could extend her life.
        I don't think that fact should be lost on people, that this
    is not only about the life of the embryo, ultimately, but also
    the life of those who have made it through the gestation period
    and now have serious problems, as my daughter does.
        Mr. Cummings. Since we are seeing that you make the same
    argument that I have made, I can appreciate that. I mean, when
    we see people who stand the possibility of suffering for the
    rest of their lives or dying and if there is a possibility, I
    guess as a parent, I share with you, I guess I would try to go
    to the ends of the Earth to try to save my child. So I can
    understand that.
        How do you respond to the notion that what is therapeutic
    cloning is basically offering some type of false hope? We have
    had some testimony about that today. There are some people who
    claim it is false hope. How do you feel about that?
        Ms. Howard. In my testimony, I pointed out that there are
    lots of false hopes I could be chasing, not only therapeutic
    cloning, but there could be false hope that a pharmaceutical
    product is going to help my daughter.
        After this juncture, after 20 or 30 years of miraculous
    advances in science in this country and overseas, there still
    is no cure for my daughter. So I am not walking around hopeful
    that there may be a cure next week or within 2 or 3 years.
        Actually, even if it takes 20 or 30 years for this science
    to ultimately bloom and come to fruition, I, as a mom, would
    hope that the next generations of mothers who have Rett
    syndrome daughters could have a cure that I do not actually
    have for my daughter.
        So if I am not here in this generation in the beginning of
    the 21st century able to help my daughter, I am hoping that
    science at least advances or I am pushing science along for the
    next 20 or 30 years so future generations do not have to cope
    with what I am coping with.
        Mr. Cummings. Dr. Kelly, if therapeutic cloning research
    produced, directly or indirectly, a cure for spinal cord
    injury, would you avail yourself of it?
        Mr. Kelly. That is a really good question. That is a really
    good question. I appreciate your asking that.
        As a matter of fact, I definitely would avail myself of it.
    At least I would--I thought I would several months ago, because
    I refused to look at the moral science of the question. I
    thought to myself, you know, let us not look at the moral
    science of it, because what happens if it turns out you need
    this to get cured? That is what led me to not look at the moral
    aspects of it.
        Now I have come to the conclusion that, No. 1, it is not
    going to lead to a cure for spinal cord injuries, for reasons I
    have already told the panel. No. 2, I have come to the
    conclusion that it is morally wrong, OK?
        I have also looked at myself. I said, now, Jim, would you
    have the guts to stand up for your convictions, your moral
    convictions? If something came out next week for--and I don't
    believe it is going to happen, I don't think it is even
    possible it could happen, I don't think it is possible it could
    happen in 10 or 20 years--but if there was a miracle and
    somebody came out next week and the cure was with cloning, if
    that is what you are asking me, right----
        Mr. Cummings. Yes, sir.
        Mr. Kelly [continuing]. I will tell you the truth, I don't
    think I would have my guts to turn my back on it, all right?
        Now, having said that, having said that, you have to
    understand that I must really believe that it is not going to
    happen or else I would not be coming in front of you today and
    trying to talk whoever is listening to this panel, this
    testimony, talk you into backing Senator Brownback's bill and
    fully banning human cloning.
        I would not be doing that, because I am fully admitting
    that I would avail myself of the cure if it was here. And I
    know it is im immoral. I am admitting it is immoral, and I am a
    weak person. I have a wife who would hate me, I know she would,
    because she does not have my moral views on this matter, and
    she would hate me if I told her, honey, you would have to stay
    with me the way I am, because I am not going to take the cure.
    I know that, if that is what it was. I will tell you, sir, I
    don't think I have the moral courage. But it is not going to
    happen.
        Mr. Cummings. Well, let me just leave you with this, then,
    with the Chair's indulgence. I think, when I look at science,
    when I look at something as simple as the computer, and the
    idea that maybe 20 or 30 years ago, 40 years ago, somebody
    could have easily said, one day we are going to be able to fax
    things across the wire and we are going to be able to have
    computers that talk to each other, I think or I am sure there
    were people who were naysayers and saying, it will never
    happen. Yet, it is happening, and things that I never imagined,
    never imagined, are happening.
        I will never forget the first time I saw a fax coming over
    a fax machine, I could not believe it.
        So I think that I often say it is the people who are the
    misfits that make a difference in our society, the ones that
    step out of the box. We are enjoying a lot of the benefits that
    come from people who have been misfits.
        Mr. Kelly. Sir, can I say something about that?
        Mr. Cummings. Yes.
        Mr. Kelly. You made the same comment as Dr. Usala, if I am
    not mistaken, about out-of-the-box thinking and misfits, right?
        Supposedly, what is supposed to be so revolutionary about
    cloning, what it might be able to do, is offer embryo stem
    cells that have the patient's own DNA, right? OK. And what you
    are saying, if I understand correctly, is if you can use out-
    of-the box thinking, then maybe that might lead to a cure that
    nobody thinks is even possible. Maybe I don't think it is
    possible. My research is telling me it is not possible. Maybe I
    am wrong, OK?
        I am glad you used the word ``out-of-the-box.'' The reason
    why is what Dr. Usala does is he started out in his research 10
    years ago with the theory that he proved later on in clinical
    trials, you saw that, that the cells respond to the environment
    that is around it. But not only do the cells do that, but now
    they are finding out in cloning that the nucleus of the cells
    respond to the cytoplasm, which is the yoke of an egg, OK, or
    the yoke of a cell. They are finding that the nucleus responds
    to that.
        So now they have come to the point, Dr. Wise Young, I
    mentioned, the Director of the Rutgers University Neuroscience
    Department, he wrote to me and he said that there is ``a
    growing consensus in the field that the most desirable cells
    for transplantation are cells that are far enough along the way
    to differentiating into desirable cells, such as neurons,
    insulin-secreting cells, radial glial or olfactory ensheathing
    glial cells, that they have a high likelihood of producing such
    cells.''
        OK, that is not really what I wanted to say, here. What
    that is saying is that embryo stem cells--early stage embryonic
    stem cells which cloning can lead to are not even considered
    the most attractive cells for implantation anymore.
        But that is not what I want to say. He wrote to me, and he
    said, ``The other recent finding that has really turned a lot
    of heads in the regenerative field is the study showing that
    skin cells can be turned into lymphocytes by using a chemical
    to permeabilitize the skin cells and soak them in lymphocyte
    cytoplasm.''
        OK, now I know this is very confusing. What this is saying
    here is that they found out that if you take the yoke of an
    egg, what they are calling the cytoplasm, and if you inject
    that into a skin cell, what that does is it bathes the nucleus
    of that cell.
        Instead of taking the nucleus out and putting in an embryo
    to make a clone in order to get stem cells, now they have found
    out that they can take the cytoplasm out of the embryo, the
    yoke out of it, or even the yoke out of another stem cell and
    put it into your skin cells, and that will bathe that nucleus
    in the skin cell, and that skin cell will turn into a stem cell
    or an embryo or whatever cytoplasm you put in it.
        Now that is completely out of the box. Because, if you want
    to call an egg a box, you are taking the yoke out of the box
    and you are putting it in there. So what you are doing now is
    making--basically, what they are after with cloning, they are
    after embryonic stem cells with a patient's DNA. What he is
    telling us here is that you can make embryonic stem cells with
    the patient's DNA, and you don't have to make an embryo to do
    it. Now that is out-of-the-box thinking.
        He also says that it is cheaper, it is safer, and it is
    more effective than going with the cloning process, and this
    man is in favor of cloning.
        Mr. Cummings. Thank you very much.
        Mr. Souder. Thank you.
        I appreciate your patience, Mrs. Davis, for letting us each
    go over on our time here.
        I yield to Congresswoman Davis.
        Mrs. Jo Ann Davis of Virginia. Thank you, Mr. Chairman.
        Ms. Howard, you said a moment ago, I believe, and you
    stressed it several times, that the cloned human embryo would
    be not fertilized. Is that correct?
        Ms. Howard. Yes.
        Mrs. Jo Ann Davis of Virginia. President Clinton's National
    Bioethics Advisory Commission, in its 1997 Report on Cloning
    Human Beings, stated that the Commission began its discussions
    fully recognizing that any effort in humans to transfer a
    somatic cell nucleus into an enucleated egg involves the
    creation of an embryo with the apparent potential to be
    implanted in utero and developed to term.
        If it is a nonfertilized egg, why would it be planted in
    utero and then come to full term?
        Ms. Howard. I am not going to--I am not here to talk about
    eggs that would be implanted in utero. I am here to talk about
    growing cells in a petri dish for 3 or 4 days that could----
        Mrs. Jo Ann Davis of Virginia. I understand that, but you
    stated, and you emphasized it more than once, that it was a
    nonfertilized egg. I am trying to find out why you think that a
    cloned human embryo was a nonfertilized egg.
        Ms. Howard. Go ahead.
        Ms. Norsigian. I was just mentioning to her that we were
    talking about asexual reproduction, but it is still potential
    reproduction. So you are right, it has the potential of being
    implanted and becoming maybe a malformed human being, but a
    human being.
        So I think most people who look at this accept that somatic
    cell nuclear transfer introduces the possibility of having
    human reproductive cloning, and that is why we are having this
    discussion and why the Justice Department is looking at the
    question of enforcement.
        I think it is also very important to get back to what you
    were saying, Mr. Cummings, about the question of, you know,
    research and the potential and do you say no.
        There is a researcher at Johns Hopkins, Dr. Gerhart, who
    has demonstrated that he has been able to solve one of the
    problems with embryo stem cells. Two of the major problems are
    the tumorogenicity and the inability to control
    differentiation, and if he in an animal model lets the embryo
    grow to a fetus and it is at the 8- or 9-week-old stage and he
    harvests germ line cells--these are no longer embryo stem
    cells, but they are still stem cells--he harvests germ cells,
    he has been able to inject that into tissue and avoid the
    problem of creating tumors.
        So that creates an example of the type of slippery slope we
    would be facing. If we knew we could have cures or we might
    potentially develop cures, do we then say, OK, we are not going
    to say 7 or 14 days is the limit, we are going to let ourselves
    grow embryos in an artificial setting to a later stage of
    development because we think we could have an effective cure?
        It does create huge moral and ethical issues to simply say,
    because we can do it, maybe we should.
        Ms. Howard. Let me speak----
        Mrs. Jo Ann Davis of Virginia. I would like to reclaim my
    time so I can ask all the questions I need to ask.
        Ms. Howard. OK, but you did ask a question. Can I explain
    briefly how to----
        Mrs. Jo Ann Davis of Virginia. If the chairman will indulge
    me and let me go over my time, sure.
        Ms. Howard. In SCNT, somatic cell nuclear transfer, i.e.,
    therapeutic cloning, the nucleus of the donor's unfertilized
    egg is removed and replaced with the nucleus of a patient's own
    cells, like skin, heart, or nerve cells. These types of cells
    are called somatic cells. No sperm is used in this procedure.
    The cells are not transplanted into the womb. The unfertilized
    egg cells are stored in a petri dish to become a source of stem
    cells that can be used to treat life-threatening medical
    conditions.
        What I think would be important to get you more background
    about----
        Mrs. Jo Ann Davis of Virginia. Is that a human cloned
    embryo?
        Ms. Howard. This is an unfertilized egg. I am not sure--let
    me say this. I know that in both bills people have raised
    questions about the definition of what an embryo even is. I am
    not going to be here to tell you--to get into that. I will not
    have a definitional debate with you, but I think it is
    important for you to see the material that the coalition has
    put out about how they hope SCNT would be used.
        Mrs. Jo Ann Davis of Virginia. I am short on my time here.
        As I understand it, the only difference in therapeutic
    cloning and reproductive cloning is simply the purpose, what
    they are used for. So I guess that is why I am having the
    confusion if it is nonfertilized.
        I guess, Ms. Norsigian, I would ask you, do you think that
    approving and permitting therapeutic cloning would then lead to
    reproductive cloning when there is effectually no difference
    except for the purpose for which they are used?
        Ms. Norsigian. I think people who have--especially the
    statement that we heard read earlier, or parts of it that were
    read by the Chair, are very good comments about how it would be
    almost impossible to enforce a ban on human reproductive
    cloning if we allowed clonal embryos to be produced en masse,
    ostensibly for research purposes, but you would never be able
    to know that they would not be, and they could be fairly easily
    used in other ways, especially given the other bills that have
    absolutely no protections of the sort that might even reduce
    that likelihood.
        So you are absolutely right, it is really the intent that
    matters here. But when you create a clonal embryo, it is an
    embryo that is capable of becoming a human being. We just would
    rely on people's good will not to do so, if there was a ban
    against human reproductive cloning.
        Mrs. Jo Ann Davis of Virginia. If you just stated that if
    you clone an embryo it has the potential to become a human
    being, then you disagree with the nonfertilized----
        Ms. Norsigian. Of course I disagree. If you have asexual
    reproduction, it is still reproduction. The fact that you are
    not using sperm is really not that relevant in terms of the
    issue of whether you can create a human being or not. It is
    very unusual, and there are people wondering, you know, this
    talk about the post-human future and all of that. But it is
    still the potential reproduction, even though it is not your
    classic fertilization the way we have always known it.
        Mrs. Jo Ann Davis of Virginia. Thank you, Mr. Chairman. I
    would yield to you, Doctor, but I don't have any time left.
        Dr. Weldon. From a biological perspective, when you put a
    nucleus from a somatic cell into an egg and it begins to divide
    and form an embryo, you have a human embryo. It has the full
    potential, if it were introduced into a woman, to grow into a
    human baby. Just like Dolly the sheep was created, the same
    way, that is what they are talking about, in using humans.
        What I think the gentlelady was trying to somehow imply is
    that it is somehow not human because you did not use a sperm to
    create it, that it is not an embryo somehow. The quote you have
    from the Bioethics Advisory Committee, President Clinton's
    Bioethics Advisory Committee, states very categorically that it
    is an embryo. That is because any biologist with his head
    screwed on right knows it is a human embryo. Despite some of
    the linguistic gymnastics that some people are trying to engage
    in on this issue, it is a human embryo.
        Mrs. Jo Ann Davis of Virginia. Thank you, Doctor, because
    it was very confusing to me.
        Thank you, Mr. Chairman.
        Mr. Souder. I want to thank this panel, as well as the
    first panel, for taking the time to come here to Washington. We
    may have additional written questions. I want to do a couple of
    things in summing up.
        One is that I thought Mr. Kelly did a good job of pointing
    out the ``box'' question. In fact, cloning is inside the box.
    It is the currently PC term. It is the term that is the trendy
    thing to do. What we need are the creative proposals that we
    have heard at all the hearings that actually have produced
    results, and that research has basically been outside the box
    and shorter in duration than the types of research that have
    not been productive.
        The question we need to be asking is, why is so much being
    driven toward nonproductive research and away from dollars that
    could be productive research? ``outside of the box'' is
    reversed on its head. There is a difference between a promise
    which is based on something and a possibility based on a hope
    that does not have any scientific evidence.
        I think as we move forward in these hearings we continue to
    look for--and as we can see from today's hearing, we had--wide
    diversity. This was not an ethics of the debate hearing.
        The second point, in one of these hearings we are going to
    get into the ethics more. I found Dr. Zavos' statement
    extremely troubling. That was what he said, we cannot be
    distracted by ethics. We are entering an era in the world where
    we had better be distracted by ethics, because these are very
    difficult questions. Individuals may disagree about when
    precisely life begins, how to define that life, how we should
    relate to each other, but just like here in the origins of
    life, we have to be concerned about ethics, and we are going to
    get into this in bioterrorism and when is a terrorist attack
    justified and not justified.
        We need to have ethics as part of the public debate. It is
    scary to think it would not be part of the public debate.
        Last, because I am sure anybody watching today is going to
    be very confused, because terminology in Washington changes
    based on kind of who wants to spin something for what time
    period, we have seen a dramatic change in the argument toward
    research cloning from human cloning.
        But somatic cell nuclear transfer, as has been stated here,
    is still a human embryo. It is a human embryo that is not
    necessarily being implanted. It is human cloning for research
    purposes, as opposed to human cloning for growing a future
    human being, but it is still human cloning, and it is just a
    different form. Changing a name to somatic cell nuclear
    transfer does not mean it is not human cloning, but it has a
    different purpose to the human cloning.
        We are debating today about the different types of human
    cloning. We crossed two different types of human cloning, but
    we were still debating human cloning and not human cloning; and
    inside human cloning, two types, one just for research
    purposes, and one Dr. Zavos was arguing was for actually
    creating future, living human beings.
        I want to once again thank all of the panelists who came
    forward today. If you have additional comments you want to
    insert for the record, or additional materials, you may.
        I want to thank all the Members who participated and look
    forward to working with you in the future.
        With that, our hearing stands adjourned.
        [Whereupon, at 3:35 p.m., the subcommittee was adjourned.]
        [Additional information submitted for the hearing record
    follows:]

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