By Kim Coghill

Washington Editor

WASHINGTON - Most members of the House Energy and Commerce Committee's Oversight and Investigations Subcommittee Wednesday approached with skepticism a hearing to examine the safety and ethical questions surrounding human cloning.

"For most of its 80 years, 'Brave New World' [written by Aldous Huxley] could be seen as a disturbing work of science fiction," subcommittee Chairman Rep. James Greenwood (R-Pa.) said in his opening remarks. "But that is no longer the case. The possible cloning of human beings is no longer relegated to the world of fiction. And the question this generation must ask is this: 'What should we do with the science?' That is what brings us here today."

Witnesses testifying represented a range of members of the scientific community, including the likes of Rael, leader of the Raelian Movement and founder of the Bahamas-based CLONAID, the first human cloning company. Others on the list were Arthur Caplan, director of the Center of Bioethics at the University of Pennsylvania in Philadelphia, and Thomas Okarma, president and CEO of Menlo Park, Calif.-based Geron Corp. Okarma testified on behalf of the Washington-based Biotechnology Industry Organization.

Greenwood said the cloning debate started picking up steam in 1997 after Scottish scientist Ian Wilmut and his colleagues successfully cloned a sheep named Dolly from a single cell of an adult sheep.

"To date, mice, sheep, cows, goats, pigs and a wild ox have been cloned," Greenwood said. "To our knowledge, primates have not been cloned."

And that could all change fairly soon.

But the question is: Should cloning be stopped? And if it shouldn't, does the government have to pay for it?

Greenwood said federally funded human cloning research is prohibited. However, private funding of such research is perfectly legal. And on top of that, there is no definitive federal statute governing privately funded human cloning experiments.

Not All Agree FDA Has Jurisdiction

The FDA claims to have jurisdiction over human cloning based on the Public Health Service Act and the Food, Drug and Cosmetic Act. However, some legal observers have raised questions about whether the FDA's authority would be upheld by the courts, Greenwood said.

"We support the FDA and want to assist the FDA in brining its considerable skills to overseeing this matter," said Rep. Billy Tauzin (R-La.), chairman of the House Committee on Energy and Commerce. "However, FDA's jurisdictional claim may suffer from being a square peg in a round hole. FDA says it can regulate human cloning because the agency has interpreted old federal laws to cover new cloning activities. The FDA argues these old federal laws regulating new drugs cover a human cell or a human fetus. I frankly do not find it obvious that a human fetus is a drug."

Regardless of who regulates human cloning, some organizations such as BIO think someone needs to step in.

"BIO opposes human reproductive cloning," Okarma said. "It is simply too dangerous technically and raises far too many ethical and social questions. That's why BIO wrote President Bush last month and urged him to extend the voluntary moratorium on human reproductive cloning, which was instituted in 1997."

In the letter to Bush, BIO President Carl Feldbaum said, "We support cloning of specific human cells, genes and other tissues that do not and cannot lead to a cloned human being. 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. This type of cloning could also produce replacement skin, cartilage and bone tissue for burn and accident victims, and result in ways to regenerate retinal and spinal cord tissue."

The letter further states that BIO was among the first to support a moratorium on cloning human beings because that specific cloning technology is viewed by the organization as unsafe and because the prospect of cloning humans raises profound moral, religious and bioethical concerns.

"It would be extremely dangerous to attempt human reproductive cloning," Okarma said. "In fact, in most animals, reproductive cloning has no better than a 3 [percent] to 5 percent success rate - that is, very few of the cloned animal embryos implanted in a surrogate mother animal survive. The others die in utero, sometimes at very late stages of pregnancy, or die at birth."

He also said some scientists have been attempting to clone many other species for the past 15 years without success. "We cannot extrapolate the data from the handful of species in which reproductive cloning is now possible to humans," he said. "This underlines that this would be an extremely dangerous procedure. It is simply unacceptable to subject humans to those risks."

Cloning Is Imminent, Safeguards Are Not

But not everyone agrees.

Two fertility experts, Panos Zavos of the Andrology Institute of America in Lexington, Ky., and Severino Antinori, a fertility doctor in Rome, say they want to clone humans to help infertile couples.

In his testimony Wednesday, Zavos said, "Human cloning is around the corner and more accurately, as I stated over and over, when it comes to human cloning - the genie is out of the bottle. The technology for cloning a human being exits and it almost exists in every in vitro fertilization high-tech laboratory across the world."

Zavos said the questions that members of Congress should be asking are, Who should develop this technology and what quality controls will be necessary in order to make the technology safe?

Another cloning supporter, Rael, is founder of the religious organization, the Raelian Movement, which believes that life on earth was created scientifically in laboratories by extraterrestrials whose name, ELOHIM, is found in the Hebrew Bible and was mistranslated to the word "God." Members of the Raelian Movement claim Jesus' resurrection was a cloning performed by the ELOHIM.

Rael's company, CLONAID, has an operational laboratory in the U.S. and four scientists currently working at cloning the first America baby. n

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