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.