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March 28, 2001
CONTACT:
Sean Tipton
202-863-2494
stipton@asrm-dc.org
Safety Concerns Render any Attempt at Human Cloning Unethical
Testimony before the Subcommittee on Oversight and Investigations Committee on Energy and Commerce U.S. House of Representatives
Presented by Michael R. Soules, MD
President,
American Society for Reproductive Medicine
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 is 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.