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Summary of Testimony
of Thomas Okarma, MD, PhD
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BIO opposes human reproductive cloning. It is too
dangerous technically and raises too many ethical and social questions. The
voluntary moratorium on human reproductive cloning should remain in place and
no federal funds should be used for human reproductive cloning.
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The Food and Drug Administration (FDA) has publicly
stated that it has jurisdiction over human reproductive cloning experiments and
that it would not approve them. BIO supports that view.
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It is critical to distinguish use of cloning technology
to create a new human being (reproductive cloning) from other appropriate and
important uses of the technology such as cloning specific human cells, genes
and other tissues that do not and cannot lead to a cloned human being
(therapeutic cloning). These techniques are integral to the production of
breakthrough medicines, diagnostics and vaccines to treat heart attacks,
various cancers, Alzheimer's, diabetes, hepatitis and other diseases.
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My company, Geron, as well as many other companies and
academic laboratories, use cloning technology for many beneficial
purposes. They include: regenerative medicine; predictive toxicology
and drug discovery; and agriculture.
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In addition to the scientific obstacles, human
reproductive cloning raises numerous ethical and social concerns. Many of these
issues strike at the heart of beliefs and values that are inherent in the human
condition. Reproductive cloning could be perceived to devalue human beings by
depriving them of their own uniqueness.
TESTIMONY OF
THOMAS OKARMA, MD, PhD
PRESIDENT AND CEO OF GERON CORPORATION
ON BEHALF OF
THE BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO)
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
COMMITTEE ON ENERGY AND COMMERCE
US HOUSE OF REPRESENTATIVES
MARCH 28, 2001
Good
afternoon. My name is Thomas Okarma. I am the President and CEO of Geron
Corporation in Menlo Park, California. Geron is a biopharmaceutical company
focused on discovering, developing, and commercializing therapeutic and
diagnostic products for applications in oncology, drug discovery and
regenerative medicine. Geron's product development programs are based upon
three patented core technologies: telomerase, human pluripotent stem cells, and
nuclear transfer.
I am
testifying today on behalf of my company and the Biotechnology Industry
Organization (BIO). BIO represents more than 950 biotechnology companies,
academic institutions, state biotechnology centers and related organizations in
all 50 U.S. states and 33 other nations. BIO members are involved in the
research and development of health care, agricultural, industrial and
environmental biotechnology products.
Mr.
Chairman, and members of the Subcommittee, thank you for the opportunity to
testify today at this important hearing on cloning. Let me start by making our
position perfectly clear: BIO opposes human reproductive cloning. It is simply
too dangerous technically and raises far too many ethical and social questions.
That's
why BIO wrote to President Bush last month and urged him to extend the
voluntary moratorium on human reproductive cloning which was instituted in
1997. I would respectfully ask for this letter to be included in the hearing
record.
It
would be extremely dangerous to attempt human reproductive cloning. In fact, in
most animals, reproductive cloning has no better than a 3-5% success rate. That
is, very few of the cloned animal embryos implanted in a surrogate mother
animal survive. The others either die in utero - sometimes at very late stages
of pregnancy - or die soon after birth. Only in cattle have we begun to achieve
some improvements in efficiency.
However, scientists have been attempting to clone many other species for
the past 15 years with no success at all. Thus, we cannot extrapolate the data
from the handful of species in which reproductive cloning is now possible to
humans. This underlines that this would be an extremely dangerous procedure.
It
is simply unacceptable to subject humans to those risks.
The
Food and Drug Administration (FDA) has publicly stated that it has jurisdiction
over human reproductive cloning experiments and that it would not approve them.
BIO supports that view.
Beneficial
Uses of Cloning Technology – Therapeutic Cloning
It
is critical to distinguish use of cloning technology to create a new human
being (reproductive cloning) from other appropriate and important uses of the
technology such as cloning specific human cells, genes and other tissues that
do not and cannot lead to a cloned human being (therapeutic cloning). These techniques
are integral to the production of breakthrough medicines, diagnostics and
vaccines to treat heart attacks, various cancers, Alzheimer's, diabetes,
hepatitis and other diseases. This type of therapeutic cloning could also
produce replacement skin, cartilage and bone tissue for burn and accident
victims, and result in ways to regenerate retinal and spinal cord tissue.
My
company, Geron, as well as many other companies and academic laboratories, use
cloning technology for many beneficial purposes. Let me explain how we use it
to develop products that could revolutionize medicine and improve the lives of
people suffering from serious illnesses.
Regenerative
Medicine
Many
diseases result in the disruption of cellular function or destruction of tissue.
Heart attacks, strokes, and diabetes are examples of common conditions in which
critical cells are lost to disease.
Today’s medicine is unable to completely restore this loss of function. Regenerative medicine, a new therapeutic
paradigm, holds the potential to cause an individual's currently malfunctioning
cells to begin to function properly again or even to replace dead or
irreparably damaged cells with fresh healthy ones, thereby restoring organ
function.
The
goal of Geron's regenerative medicine program is to produce transplantable
cells that provide these therapeutic benefits without triggering immune
rejection of the transplanted cells. This could be used to treat numerous
chronic diseases such as diabetes, heart disease, stroke, Parkinson's Disease
and spinal cord injury.
At
Geron, therapeutic cloning technology is one of the techniques we use to create
pure populations of functional new cells that can replace damaged cells in the
body. For example, we are learning how to turn undifferentiated human
pluripotent stem cells into neurons, liver cells and heart muscle cells. Thus far, these human replacement cells
appear to function normally in vitro, raising
the possibility for their application in the treatment of devastating chronic
diseases affecting these tissue types. This would, for instance, allow patients
with heart disease to receive new heart muscle cells that would improve cardiac
function. Cellular cloning techniques are a critical and necessary step in the
production of sufficient quantities of vigorous replacement cells for the
clinical treatment of patients.
Predictive
Toxicology/Drug Discovery
Geron
is also developing research tools to facilitate the safe development of new
drugs. The use of normal, cloned human
liver cells to test new drugs under development for certain toxic metabolites
would reduce the danger of human clinical trials by eliminating such compounds
before human testing. This process could streamline and make safer the drug
development process, thereby reducing by several years drug development time,
bringing drugs to patients sooner and with greater safety, and reduce the
reliance upon animal testing.
Agriculture
Geron
uses cloning technology for applications in agriculture as well. These include
producing animals with desirable qualities such as disease resistance,
longevity, or improved product quality. Animals can also be cloned to produce
proteins for human therapeutic use such as human antibodies, allowing for
large-scale production of vaccines.
Ethical Concerns of Reproductive Cloning
In addition to the
scientific obstacles, human reproductive cloning raises numerous ethical
and social concerns. When the moratorium was imposed in 1997, scientists,
ethicists, and policy makers believed that the various ethical issues raised by
human cloning had not been resolved. At the time, the National Bioethics
Advisory Commission (NBAC) called human cloning "morally
unacceptable".
Mr.
Chairman, that is still true. Not only is there no consensus in our society
about how to resolve the ethical concerns implicated by human reproductive
cloning, these issues have not yet even been adequately discussed. Many of
these issues strike at the heart of beliefs and values that are inherent in the
human condition. What does it mean to be an individual? How should we view our
parents, brothers, sisters, and children? How does the world around us
influence our intellectual, physical and spiritual development? These are just
a few of the questions raised by human cloning. In my view, reproductive cloning would devalue human beings by
depriving them of their own uniqueness.
To
allow human reproductive cloning without a full and fair discussion of these
and other moral issues would be irresponsible. Worse yet, it could lead to a
backlash that would stifle the numerous beneficial applications of therapeutic
cloning technology - some of which I have described today - that could lead to
cures and treatments for some of our most deadly and disabling diseases.
Conclusion
Mr.
Chairman, human reproductive cloning remains unsafe. Moreover, the ethical
issues it raises have not been fully debated throughout our society. Therefore,
the voluntary moratorium on human reproductive cloning should remain in place
and no federal funds should be used for human reproductive cloning.
Thank
you. I'd be happy to answer any questions.
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