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Safety Concerns Render any Attempt at Human Cloning
Unethical
Testimony before the Subcommittee
on Presented by Michael R. Soules,
MD 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:
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. Return to Press Releases
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