No human cloning without FDA approval
WASHINGTON (AP) -- A Chicago physicist's plan to clone a human
is propelling a race by Congress and more than a dozen states to ban
cloning, but Richard Seed already faces a big obstacle: The Food and
Drug Administration.
The FDA says it will shut down anyone who tries cloning without its
permission, an intervention that scientists welcomed Monday as a way
to give lawmakers more time to carefully word anti-cloning bills so they
don't inadvertently ban lifesaving medical research.
''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.''
FDA investigators are tracking down Seed to make clear to him 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, the 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, he said, ''we're more interested in the 277
failures than in the success.''
Seed did not return a call for comment, but says he plans to clone a
person within 18 months. A physicist, Seed has no medical degree, no
laboratory backing and little money, so many scientists aren't taking him
seriously. He and a brother, Randolph, a Chicago surgeon, did pioneer a
human embryo transfer technique during the 1980s, but their for-profit
company fizzled.
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.
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,'' said Carl Feldbaum of the
Biotechnology Industry Organization, which represents biotechnologists
involved in cloning research.
''It's been a public and media assumption that there is nothing on the
books that would even slow or stop Dr. Seed,'' Feldbaum said. FDA
intervention ''creates at least some breathing space.''
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 Jan. 1, using
wording similar to Clinton's.
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-Mich., a nuclear physicist, wrote the bill that
has made the most progress in Congress. 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.
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