Food & Drug Administration Enters Cloning Fray

January 19, 1998

WASHINGTON (AP) -- The Food and Drug Administration has a warning for the Chicago physicist who wants to clone a human: The agency will shut down anyone who tries without its permission.

Richard Seed's cloning plans have sparked a public outcry and a race by Congress and more than a dozen states to ban cloning. With the FDA filling what critics had called a regulatory vacuum, scientists say lawmakers should take more time to ensure vaguely worded anti-cloning bills don't also ban lifesaving medical research.

"It's been a public and media assumption that there is nothing on the books that would even slow or stop Dr. Seed," said Carl Feldbaum of the Biotechnology Industry Organization, which represents biotechnologists involved in cloning research. FDA intervention "creates at least some breathing space."

FDA investigators plan to make clear to Seed that federal regulations require that he file for FDA approval to attempt cloning -- permission highly unlikely.

"We're not only able to move, we're prepared to move," said Dr. Michael Friedman, FDA's acting commissioner, noting the agency can go to court to stop unauthorized cloning attempts.

"The scientific issues are far from clear and ... there are some significant ethical concerns that have to be dealt with," added Friedman, noting that the first cloning success -- the Scottish sheep Dolly -- took 277 tries. For safety reasons, "We're more interested in the 277 failures than in the success."

Seed did not return a call for comment, but he has said he plans to clone a person within 18 months. A physicist, Seed has no medical degree, no laboratory backing and little money, so scientists aren't taking him seriously.

But President Clinton urged Congress to ban human cloning, congressional leaders have pledged quick action after they return next week, and bills are pouring into state legislatures.

Scientists say broadly worded bills already pending in Congress would ban cloning-related research that could one day grow replacement organs, mend spinal-cord injuries and better treat infertility. The key, they say, is banning only baby-making by cloning.

"One man who's on the fringe has drawn a lot of attention in Washington and state capitals," said Dr. Benjamin Younger of the American Society for Reproductive Medicine. "If they are going to do this, come up with legislation that bans cloning but protects research."

But scientists' biggest alarm came from Florida, where a bill proposed making any cloning of human DNA a felony -- even though cloning human genetic material is standard practice in genetics research, the making of critical medicines and even police DNA fingerprinting. The bill was withdrawn after its authors "realized this would have stopped biomedical research in Florida in its tracks," Feldbaum said.

After Dolly's creation last year, Clinton proposed a narrow ban: a five-year moratorium on creating humans through "somatic cell nuclear transfer technology," the Dolly method. That involves creating a pregnancy solely by replacing an egg cell's nucleus with the nucleus of another cell. No lawmaker is yet sponsoring Clinton's bill, and Congress didn't act last year because few members then thought human cloning attempts were close.

California, however, banned human cloning effective January 1, using wording similar to Clinton's.

But it isn't free of critics: Some doctors say the somatic cell definition is worded so vaguely that it could inhibit research to make older women's eggs more fertile by simply housing their genetic contents inside a younger woman's egg.

Rep. Vernon Ehlers, R-Michigan, wrote the bill that has moved furthest in Congress, and denies that it is too broad. It would ban federal funding of any "research that involves the use of a human somatic cell" to clone. It also bans embryo research, another issue.

Ehlers, a nuclear physicist, argues that his bill would allow cloning non-embryo cells, plants and animals. "They should be grateful there's a scientist offering this legislation who is in support of most of what they are trying to do," he said.

But at least a half-dozen other lawmakers are writing their own cloning bills. It's unclear yet which one will prove "the best way to deal with this threat," said Rep. Thomas Bliley, R-Virginia, whose House Commerce Committee must approve any ban.