On March 28, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing to examine how well the Food and Drug Administration (FDA) is overseeing efforts to clone humans.
“The issue of human cloning and these announced experiments raise scientific, medical, ethical, moral, and ultimately, policy questions that we as a country must confront,” stated Energy and Commerce Committee Chair Billy Tauzin (R-LA).
The subcommittee heard controversial and widely disparate testimony from several scientists. Dr. Thomas Okarma of the Biotechnology Industry Organization (BIO) stated, “BIO opposes human reproductive cloning. It is simply too dangerous technically and raises far too many ethical and social questions.” He added that the success rate for animal reproductive cloning was less than 3 to 5 percent.
Dr. Panos Michael Zavos of the Andrology Institute of America, who intends to pursue human cloning, said that the failure rate was due to “other people’s incompetence in cloning,” adding: “We have a technology that will inevitably be developed….The genie is out of the bottle. The question is how do you put the genie back in the bottle and disseminate it safely?”
Noting that cloning technology could be used for therapeutic cloning, or the cloning of cells, genes, and other tissues, Dr. Okarma said, “These techniques are integral to the production of breakthrough medicines, diagnostics and vaccines to treat heart attacks, various cancers, Alzheimer’s, diabetes, hepatitis, and other diseases.”
Dr. Mark E. Westhusin of the Texas A&M University, College of Veterinary Medicine, also noted, “Proponents of human cloning as a means of assisted reproduction have pointed out that even with accepted practices of assisted reproduction such as in vitro fertilization, success rates are low and pregnancy losses higher than in natural reproduction. This is indeed the case, but hardly to the extent seen in cloning where only 1-5 percent of the procedures performed result in offspring, and a significant number of these either die at birth or require intensive care for several weeks to keep them alive.”
Dr. Rudolf Jaenishch of the Massachusetts Institute of Technology agreed, saying, “The experience with animal cloning allows us to predict with a high degree of confidence that few humans will survive to birth and of those, the majority will be abnormal.”
Expressing her concern about the unknown consequences of human cloning, Rep. Diana DeGette (D-CO) asked several panel members, “Who is going to bear the financial burden of genetic abnormalities?” None of the witnesses offered a clear answer to the question.
Reiterating and clarifying the FDA’s role in regulating human cloning, Dr. Kathryn Zoon of the FDA stated, “The FDA views the use of cloning technology for human cloning as a cause for public health concern.” She further stated that the FDA does not permit the use of cloning technology for human cloning at this time, and that professional organizations, institutional review boards, academia, scientists, and others were notified of the ban on human cloning in 1998.
Dr. Zoon also told the subcommittee that the FDA continues to notify individuals expressing an interest in human cloning that such experiments are not currently permitted. Such notification has been presented to Dr. Brigitte Boiseelier of Hamilton College, who told the subcommittee that she is overseeing the work of five scientists in their attempts to clone a human. Individuals interested in conducting such research must first submit an Investigational New Drug (IND) application to the FDA. However, Dr. Boiseelier’s group has not yet submitted an IND.
