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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. Michael R. Soules, Professor of Obstetrics and Gynecology, and Director
of the Division of Reproductive Endocrinology and Infertility at the University
of Washington in Seattle, Washington. Currently I am
President
of the American Society for 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; (ob/gyns, reproductive
endocrinologists, and urologists), reproductive biologists, laboratory
directors, nurses and mental health professionals, all of who are dedicated to
advancing the cause of reproductive medicine.
I
have 3 simple points I wish to make in my testimony today:
First,
that ASRM finds unacceptable any attempt at reproductive cloning of an existing
human being. At this time, there is no clinical, scientific, therapeutic or
moral justification for it. Put simply, this a technology that is not ready for
prime time.
Second,
that we are satisfied that the Food and Drug Administration already has the
legal authority to stop any such attempts, the FDA has made that clear to the
reproductive medicine community. Therefore we do not think there is a need for
new legislation, or new activity at the FDA, on this matter.
Third,
I want to provide some information to help the committee understand the
differences between reproductive cloning and sexual reproduction. These
differences are at one level obvious, but if one follows recent media reports,
often misunderstood.
THE
ASRM STANCE
ASRM
has been on record as opposing attempts at human cloning since the announcement
of the successful cloning of a sheep in 1997. We reiterated this stance in 1998
by leading the effort for a moratorium on human cloning by scientific groups.
That moratorium has now been joined by nearly every reputable and relevant
scientific organization of which we are aware. We have also assisted policy
makers in determining the best way to protect the public on this issue. We have
participated in earlier Congressional hearings and worked on cloning
legislation. In November of last year our ethics committee released a very
thoughtful report on somatic cell nuclear transfer (cloning), again concluding
that because the safety and efficacy of the
procedure
had not been established, it would be unethical at this time to attempt human
cloning. This year, in response to media reports and other non-scientific
events, we again stated our view that attempts at cloning are unethical.
Please
note we are not making a judgment on the ultimate ethical validity of human
cloning. It is possible that some form of cloning might, under some
circumstances, be warranted. We simply have not yet made that determination
within our professional society nor has the general public. More
information and indeed more discussion are needed. We welcome those discussions,
but at present we need not come to any conclusion. Until more is understood
about cloning in animals, there is no ethical justification for attempting it in
humans.
We
have learned how to use cloning with microscopic organisms and any of us who
gardens know cloning works with many plants (e.g., apple). 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 it 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 it in human beings.
FDA
CONTROL
Fortunately,
the very lack of scientific evidence that the procedure is safe or effective
(that leads us to conclude it is unethical to attempt human cloning), would
allow the FDA to stop any attempt at human cloning. The FDA has said quite
clearly that any attempt at human cloning would require a New Drug Application (NDA),
and I feel certain that such an application would not be approved given the
current scientific realities.
I
realize there have been calls for additional or more explicit legislative
prohibitions on human cloning. We feel these would be unnecessary and
potentially harmful.
We
have seen in other countries, in some of the states, and even in Congress
proposed legislation which, if enacted, would endanger research, deny therapies
and even hinder drug production in areas that have nothing whatsoever to do with
cloning.
The
very first tenant of medicine in the Hippocratic oath is "First, do no
harm." The Hippocratic oath appears to apply in this legislative
context as well. Existing law gives FDA the authority to stop human cloning.
Additional legislation will not deter rogue scientists from making an
ill-advised attempt at cloning outside U.S. jurisdiction. Therefore ASRM
supports current FDA policy and sees no need for new legislation.
ASSISTED
REPRODUCTION IS NOT CLONING
I
also want to provide the committee some assurance in regards to advanced
therapies for infertility. Despite what you might see in the news media, human
cloning is not easy, nor imminent. It presents many more scientific challenges
than have been generally portrayed. People have said that anyone could
take current technology used for assisted reproduction and apply it to human
cloning. This is simply not true.
First,
while we are constantly improving our ability to treat patients suffering from
the disease of infertility, it is still far from easy. The education, training,
and equipment required are extensive. Frankly, we resent the media reports that
make it appear that anyone could set up an IVF clinic in their garage. The
asexual replication in cloning is nothing like the Assisted Reproduction that
has helped provide families with more than 100,000 new children in the U.S.
alone.
More
significant however, there are huge fundamental differences between Cloning and
sexual reproduction, even if that reproduction occurs in a laboratory in both
instances. In an IVF procedure we help a sperm and an egg "get
together.” Just as with natural conception, half the genetic material
comes from the mother and half from the father. These gametes mix and
mingle and align themselves in new ways to form a new and unique genetic
combination. Cloning is the replication of an existing genome, and it’s simply
a copy. This is very, very different from the new being created through sexual
reproduction.
For
some primitive species, cloning is the main method of reproduction. However, it
is sexual reproduction that has given us the magnificent diversity of species we
have on our planet today. Many of the problems seen in recent attempts to
clone animals stem from the fact that these clones are replications and not new
combinations.
I
take care of infertile patients every day. I employ a range of medical
therapies, many of them quite complicated to help people have the children they
so desperately want. My colleagues and I are interested in helping our
patients have children and start families. Infertility is an emotional
devastating disease. Infertile patients are desperate. Anyone who
justifies cloning based on requests from infertile patients is pandering to a
vulnerable audience.
However,
we have seen first hand in the U.S., 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. I am fearful that a negative decision may be made on stem
cell research that will cause needless suffering for patients with heart
disease, diabetes or Parkinson’s disease. Please do not make these situations
worse by enacting new and unneeded prohibition on human cloning.
I
thank you for your time and will be happy to answer any questions.
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