[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:]

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    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:]

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    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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    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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