By Kim Coghill

Washington Editor

WASHINGTON - Following a hearing Wednesday, at least three members of the House said they are considering submitting legislation this year making it illegal to clone a human.

And Ari Fleischer, spokesman for President Bush, said the president opposes such cloning and will work with Congress to pass a bill banning such science.

Six hours of testimony on both sides of the issue didn't do much to change the minds of members of the House Energy and Commerce Committee's Oversight and Investigations Subcommittee. Chairman Rep. James Greenwood (R-Pa.) said he or Rep. Peter Deutsch (D-Fla.), the ranking member, probably will introduce legislation this spring placing a ban on the practice. Rep. Bill Tauzin (R-La.) chairman of the House Committee on Energy and Commerce, also said he will consider introducing such a measure. (See BioWorld Today, March 29, 2001.)

If a ban passes, the U.S. will join the ranks of Ireland, Israel, Spain and Italy as countries that put a stop to cloning. Korea, Canada, New Zealand and Russia have legislation on the way.

With bans popping up all over the world, scientists such as Rael, leader of the religious Raelian Movement, and his colleague Brigitte Boiseelier, visiting assistant professor of Chemistry at Hamilton College in Clinton, N.Y., are at a disadvantage when trying to make a case for the usefulness of their research.

Rael's religious movement believes 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 movement believe Jesus' resurrection was a cloning performed by the ELOHIM.

Rael's human cloning company, CLONAID, is based in the Bahamas and has labs in the U.S. In mid-March, Rael released a statement saying the company may soon be listed on a stock market.

"The interest of investors is overwhelming, and we received an offer from several venture capital companies to buy 5 percent of CLONAID shares for $5 million U.S.," a statement released by Rael said. "This means that the company is worth $100 million U.S."

Rael's statement said CLONAID has been contacted by 1,000 potential customers ready to pay $200,000 each for a clone.

But during the hearing Wednesday, in the interest of safety, neither Rael nor Boiseelier would say in which lab the first clone would be made.

If others in Congress follow the lead of Greenwood and President Bush, Rael will not clone a human in the U.S.

Even two fertility experts looking to create a clone by the end of the year say they likely will look outside the U.S. to find a location for their clinic.

The two 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.

And even without a law that bans cloning human beings, it is not likely that a scientist could get FDA approval to conduct the research anyway.

"I can assure the members of this committee and the American public that FDA views the use of cloning technology to clone a human being as a cause for public health concern," said Kathryn Zoon, director for the FDA's Center for Biologics Evaluation and Research.

"Because of the unresolved safety questions on the use of cloning technology to clone a human being, FDA would not permit the use of cloning technology to clone a human being at this time, she said."

But Tauzin said he's not sure the FDA has jurisdiction over cloning. "I frankly do not find it obvious that a human fetus is a drug," he said.

Zoon said cloning would be subject to both the biologics provisions of the Public Health Service Act and the drug and device provisions of the Federal Food, Drug, and Cosmetic Act.

"Before any cloning research can begin, the researcher must submit an IND request to FDA, which FDA would review to determine if such research could proceed," Zoon said.

Following the reports about cloning of Dolly the sheep in 1997, there were reports in the media that scientists were contemplating using cloning technology to clone human beings, Zoon said. The FDA responded by notifying professional organizations, institutional review boards and several individuals with an interest in using somatic cell nuclear transfer to clone a human being that clinical research could proceed only when an IND was in effect.

The letter stated that until significant safety issues are appropriately addressed, FDA would not permit any such investigation to proceed, Zoon said.

In 1997, former President Bill Clinton placed a ban on use of federal funds for cloning and encouraged Congress to pass legislation addressing the research. Hearings were held, but no legislation was introduced. n

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