Copyright 2001 eMediaMillWorks, Inc.
(f/k/a Federal
Document Clearing House, Inc.)
Federal Document Clearing House
Congressional Testimony
June 19, 2001, Tuesday
SECTION: CAPITOL HILL HEARING TESTIMONY
LENGTH: 2024 words
COMMITTEE:
HOUSE JUDICIARY
SUBCOMMITTEE: CRIME
HEADLINE: HUMAN CLONING BAN
TESTIMONY-BY: THOMAS OKARMA, PHD, MD, PRESIDENT AND CEO
OF
AFFILIATION: GERON CORPORATION ON THE BEHALF OF THE
BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO)
BODY:
June 19, 2001
Testimony of Thomas
Okarma, PhD, MD President
and CEO of Geron Corporation
On behalf of the Biotechnology Industry
Organization (BIO)
Before the Subcommittee on Crime, House Judiciary
Committee
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 earlier this
year 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. It took over 270 attempts before Dolly was
successfully cloned. 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. Rogue and grandstanding
so-called scientists who claim they can - and will - clone humans for
reproductive purposes insult the hundreds of thousands of responsible, reputable
scientists who are working hard to find new therapies and cures for millions of
individuals suffering from a wide range of genetic diseases and conditions.
The Food and Drug Administration (FDA) has publicly stated that it has
jurisdiction over human reproductive cloning experiments and that it will not
approve them. BIO supports that view and hopes that the next FDA commissioner -
whoever that might be - will assert FDA's current statutory authority
forcefully.
There are also many ethical concerns raised by the specter
of cloning. As noted in BIO's letter to the President, "Cloning humans
challenges some of our most fundamental concepts about ourselves as social and
spiritual beings. These concepts include what it means to be a parent, a
brother, a sister and a family.
"While in our daily lives we may know
identical twins, we have never experienced identical twins different in age or,
indeed, different in generation. As parents, we watch with wonder and awe as our
children develop into unique adults. Cloning humans could create different
expectations. Children undoubtedly would be evaluated based on the life, health,
character and accomplishments of the donor who provides the genetic materials to
be duplicated. Indeed, these factors may be the very reasons for someone wanting
to clone a human being."
As you can see, Mr. Chairman, 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 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 will describe
today - that could lead to cures and treatments for some of our most deadly and
disabling diseases.
Beneficial Uses of Cloning Technology
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 many diseases. They 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.
Let me briefly explaining a
cloning technology - somatic cell nuclear transfer - and how it is used for
research purposes. First, the nucleus of an egg cell is removed. In its place,
we insert the nucleus of an already differentiated cell (a cell that performs a
specific function in the body). Chemicals are added to stimulate the egg to
start dividing. At about 3-5 days, a blastocyst is formed which contains an
inner cell mass comprised of undifferentiated, pluripotent cells. These cells
are removed and used for research. The research value of these cells is
enormous. These stem cells have the potential to form any cell in the body and
can replicate indefinitely. Studies in animals demonstrate that this could lead
to cures and treatments for millions of Americans who suffer from diseases and
disabilities such as diabetes, stroke, Parkinson's Disease, heart disease, and
spinal cord injury.
As exciting as that is - it's only a part of the
story. The full potential of this technology comes from its use in regenerative
medicine.
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.
Somatic cell nuclear transfer research
is essential if we are to achieve our goals in regenerative medicine. We must
understand the biological properties of the egg cell (and the transferred
nucleus) that cause a differentiated cell to turn into a pluripotent cell. This
process is called "re-programming" - and we're still not sure how it works.
That's why we need to continue to perform research.
At Geron, our aim is
to harness and therapeutically apply the power of this biology. Once we fully
understand re-programming we will be able to develop specific cells for
transplantation without immune rejection. We'll do that by taking a
differentiated cell from a particular individual and re- programming it to form
a pluripotent cell from which we can produce the differentiated cells we need
for transplantation back into that individual. By using the patient's own cells
as starting material, we will avoid complications due to immune response
rejection.
However, this is precisely the research that would be banned
by the Weldon bill. Because the Weldon bill does not distinguish between
reproductive cloning and use of cloning for research purposes, it will cut off
this work and prevent its therapeutic applications from reaching patients. In
contrast, the bi-partisan bill introduced by Reps. Greenwood, Deutsch, and
others bans reproductive cloning but allows the continuation of research. BIO
supports Greenwood/Deutsch because it strikes the appropriate balance between
prohibiting acts that are unsafe and unethical, while promoting vital medical
research.
It is important to emphasize that once we understand the
molecular biology of re-programming, we will no longer need to use egg cells or
create blastocysts. Therefore, this technology is likely to be used only for a
short, finite period of time. Moreover, understanding the biology re-programming
is a critical step to improve the usefulness of adult stem cells. Ironically,
therefore, the Weldon bill will also be a setback to adult stem cell research.
Conclusion
As the current Congress pursues legislative
prohibitions on human reproductive cloning, we urge caution and a distinction
between reproductive and therapeutic cloning. We all agree that given the
current safety and social factors, human reproductive cloning is repugnant.
However, it is critical that in our enthusiasm to prevent reproductive cloning,
we not ban vital research, turning wholly legitimate biomedical researchers into
outlaws, and thus squelching the hope of relief for millions of suffering
individuals.
Our nation is on the cusp of reaping the long dreamed of
rewards from our significant investment in biomedical research. The U.S. biotech
industry is the envy of much of the world, especially our ability to turn basic
research at NIH and universities into applied research at biotech companies and
in turn, into new therapies and cures for individual patients. Using somatic
cell nuclear transfer and other cloning technologies, biotech researchers will
continue to learn about cell differentiation, re- programming, and other areas
of cell and molecular biology. Armed with this information, they can eventually
crack the codes of diseases and conditions that have plagued us for hundreds of
years, indeed, for millennia.
In conclusion, Mr. Chairman, human
reproductive cloning remains unsafe, and the ethical issues it raises have not
been reasonably resolved. It should be prohibited. However, as Congress seeks to
outlaw reproductive cloning, it must not write legislation that will stop
research using cloning technology. Unfortunately, the Weldon bill fails that
test. Simply put, enactment of the Weldon bill will stop critical therapeutic
research in its tracks. Only Greenwood/Deutsch strikes the right balance.
Thank you for the opportunity to testify. I'll be happy to answer any
questions.
LOAD-DATE: June 20, 2001