Hearing on Cloning Humans
by Earl Lane
Washington-With both an international group of scientists and a Canadian-based religious group devoted to UFOs talking about cloning human beings, Congress members on both sides of the aisle called yesterday for a federal law explicitly banning such attempts.
Rep. Billy Tauzin (R-La.), chairman of the House Energy and Commerce Committee, said he was troubled by what he called "tenuous" authority on the part of the Food and Drug Administration to regulate human cloning. The FDA would do so using its authority over experiments involving cells and cellular products.
"I'm deeply concerned whether that would hold up in court," Tauzin said during a hearing on cloning issues by his committee's subpanel on oversight and investigations.
"We should make clear that human cloning is not legally acceptable in the United States," said Rep. Peter Deutsch of Florida, the ranking Democrat on the oversight subcommittee. "I believe we will be able to craft legislation to that effect." At the White House yesterday, spokesman Ari Fleischer said President George W. Bush supports outlawing human cloning research in the United States. "The president will work with Congress" on a federal statute, Fleischer said. "The president believes that no research-no research-to create a human being should take place in the United States." Former President Bill Clinton issued an executive order in 1997 directing that no federal funds be spent for human cloning, a ban Fleischer said Bush supports.
Kathryn Zoon, director of the FDA's Center for Biologics Evaluation and Research, told the House hearing that her agency "would not permit the use of cloning technology to clone a human being at this time." But under questioning by Tauzin, she acknowledged FDA's authority is limited to insuring the safety of investigational drugs and procedures. If the safety of cloning was established, Tauzin asked, would the FDA be compelled to allow it? "Yes," Zoon responded.
The congressional hearing was called in the wake of media reports that a consortium of scientists led by Dr. Panos Zavos, a reproductive specialist formerly on the faculty of the University of Kentucky, and Dr. Severino Antinori, an Italian fertility specialist, are organizing an effort to clone a human in an undisclosed site abroad. There also have been reports that the Raelians, a religious group that believes aliens from another planet created all life on Earth, is organizing a cloning project called Clonaid that is to be based somewhere in the United States.
Rael, the leader of the group, attended the hearing in a flowing white jumpsuit and listened intently while one of his followers, a chemist named Brigitte Boisselier, defended the group's plans. She declined to say where the cloning might be attempted but said her group wants to do it in the United States. Boisselier said, however, that she had received a letter from the FDA on Monday telling her the agency will ban any studies of human cloning in this country, given the major unresolved safety questions. Asked whether Clonaid will apply for formal FDA approval of any cloning attempts here, Boisselier would say only that she will review the FDA letter with her attorney.
Zavos said his group does not seek to do any cloning in the United States and said the FDA should have authority to regulate such research.
In cloning, which has been accomplished with mixed success in five mammalian species-sheep, mice, goats, cows and pigs-the researchers extract the DNA-containing nucleus from an unfertilized egg, or ovum. They then insert into it a nucleus that has been extracted from a mature body cell of a donor. The egg is then implanted into an animal's uterus. If conditions are right, the DNA of the donor nucleus begins to direct the growth and development of an embryo that eventually grows to term as an essentially identical genetic copy of the donor animal.
Scientists who also testified yesterday questioned the credibility of the proposed human cloning efforts and said that the technology currently in use to produce cloned animals has had unpredictable and often devastating results.
Only a small percentage of cloning attempts produce viable embryos, they said, and many cloned animals who survive can be affected by a variety of problems, including obesity, heart and lung defects, and immune system deficiencies.
Zavos predicted that human cloning "is just around the corner" and said his group intends to do careful screening of potential clones to ensure that the embryos are viable before implantation in a woman's womb. He called cloning "a human right that should not be taken away from people because someone or some group of people have doubts about its development. We have no intentions to step over dead bodies or dead babies to accomplish this." But Rudolf Jaenisch, a specialist on mammalian development at the Whitehead Institute for Biomedical Research in Cambridge, Mass., told the House panel that even apparently healthy adult animal clones may have subtle defects, such as brain deficits, that cannot be easily recognized. "I believe there's probably not a normal clone around," Jaenisch said. He said the most likely cause of abnormal clones is faulty genetic reprogramming that cannot be detected using existing prenatal screening methods. "There are no methods available now or in the foreseeable future to assess whether the genome of a cloned embryo has been correctly reprogrammed," Jaenisch said. In an article in the journal Science this week, Jaenisch and Ian Wilmut-who cloned the first mammal, a sheep named Dolly-call human cloning "dangerous and irresponsible," and say any resulting babies likely would die early or suffer numerous abnormalities.
Even before yesterday's hearing, there had been bipartisan political agreement that human cloning should not proceed and major scientific organizations also backed such a ban in the wake of the successful cloning of Dolly in 1997. Congress considered anti-cloning legislation in 1998 after Chicago physicist Richard Seed announced his intention to market cloning techniques to infertile couples, a promise that has not yet come to pass.
But scientific organizations also lobbied against bills that they said were drawn too broadly and could hamper promising medical research using cloning-related techniques not aimed at producing embryos for implantation in the womb. The Senate eventually set aside a bill to outlaw human cloning.
Several states have passed anti-cloning legislation and it is pending in others.
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