Copyright 2001 eMediaMillWorks, Inc.
(f/k/a Federal
Document Clearing House, Inc.)
Federal Document Clearing House
Congressional Testimony
March 28, 2001, Wednesday
SECTION: CAPITOL HILL HEARING TESTIMONY
LENGTH: 2334 words
COMMITTEE:
HOUSE ENERGY AND COMMERCE
HEADLINE:
TESTIMONY OVERSIGNT OF
HUMAN CLONING RESEARCH
TESTIMONY-BY: THOMAS B. OKARMA PH.D.M.D , PRESIDENT AND
CEO
AFFILIATION: GERON CORPORATION MENLO PARK,
CALIFORNIA ,94025
BODY: March 28, 2001 The House
Committee On Energy and Commerce W.J. "Billy" Tauzin, Chairman Dr. Thomas B.
Okarma Ph.D.,M.D. President and CEO Geron Corporation Subcommittee on Oversight
and Investigations Hearing Issues Raised by
Human Cloning
Research Dr. Thomas B. Okarma Ph.D.,M.D. President and CEO Geron Corporation
Summary of Testimony of Thomas Okarma, MD, PhD - 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. -
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. - 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. - 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. - 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.
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.
LOAD-DATE: March 30,
2001, Friday