<DOC>
[107th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:86435.wais]
MEDICAL SCIENCE AND BIOETHICS: ATTACK OF THE CLONES?
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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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WASHINGTON : 2003
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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
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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?
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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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