Tempest in a Pill Box: FDA balks at approving RU-486
Family-planning issues in the United States always seem to provoke a
fight. The newest battle is over the Food and Drug Administration's approval of the French
drug RU-486, which would provide American women access to safe early abortions.
Anti-abortion activists in the United States have called RU-486 a "human
pesticide." George W. Bush has vowed to prevent its use if he's elected president.
And now the FDA is showing signs that politics rather than sound science will decide
whether American women will ever have access to this birth control alternative.
Designed for women 49 days pregnant or less, RU-486-also known as mifepristone-has been
used by more than a half million women in France, Sweden, and Great Britain since 1988.
Since its approval, RU-486 has accounted for one-third of all abortions in France, though
the total number of abortions in that country has not increased. The drug is also widely
available in China, where Planned Parenthood estimates that it has been used to terminate
as many as 3 million unwanted pregnancies since 1988.
RU-486 works by making it difficult for a fertilized egg to remain attached to the
uterus; a second drug, misoprostol, is then used to trigger contractions. The pill removes
the need for surgery and can be taken in the privacy of one's home-something advocates
hail as a way to remove abortion clinics, healthcare providers, and patients as targets of
anti-abortion activists. The drug also promises to offer more reproductive choice:
Currently, 86 percent of U.S. counties have no available abortion services. But a recent
study by the Kaiser Family Foundation found that one in three gynecologists who do not now
perform surgical abortions would offer RU-486.
After clinical trials in the United States, the FDA declared in 1996 that RU-486 was
safe and effective, though it also said it needed additional information on manufacturing
practices and distribution. Pro-choice advocates believed that the FDA was on track to
approve the drug by the beginning of 2000.
In June, however, the FDA told the Population Council-a private, nonprofit
family-planning research group with U.S. patent rights to RU-486-that it was considering
approval of the controversial drug, but with tight restrictions. According to Vicki
Saporta, executive director of the National Abortion Federation, the FDA has proposed that
only doctors trained in surgical abortions be permitted to prescribe the drug. Also,
providers would have to have hospital admitting privileges and be based within one hour of
an emergency room in case of complications, and doctors would have to be specially
licensed and trained.
"Viagra has fewer restrictions and more than thirty men have died using that
drug," says Saporta. "No women, in Europe or the United States, have died from
Family-planning advocates worry that the proposed restrictions would erase the drug's
promise of accessibility. According to Gloria Feldt, president of Planned Parenthood, such
rules would "so violate physicians' privacy and security concerns that mifepristone
could be approved by the agency but never really be on the market." The restrictions
would essentially wipe out broader access to the drug, since so few U.S.
physicians-whether from fear of anti-abortion violence or for other reasons-currently
perform surgical abortions.
The National Abortion Federation's Saporta adds, "These restrictions can only be
viewed as politically motivated, and the FDA should be above the political fray."
The FDA has until September 30 to decide on approval for the drug-with or without tight
restrictions-or call for a further delay. For more information, see www.earlyoptions.org/. by Marilyn Berlin Snell
Who knew fresh veggies could be so popular? The organic salad bar at Malcolm X
Elementary School in Berkeley, California, is a big hit with the kids. Thanks to
Berkeley's school board, which passed an organic food policy last year, all of the
district's 10,000 students are being introduced to the joys of non-irradiated,
non-bioengineered, pesticide-free food-some of which students grow themselves in school
gardens. Berkeley's Center for Ecoliteracy received a grant from the U.S. Department of
Agriculture and is spearheading the effort.
A year into the program, 12 of the district's 15 schools (including Malcolm X) have
organic gardens. The goal is for schools to grow 25 percent of the organic produce needed,
with local family farms that practice sustainable agriculture providing the rest. -M.B.S.
Energy to Burn!
Switching from an average car to a 13-miles-per-gallon sport utility vehicle for one
year would waste more energy than if you . . . . . .
left the refrigerator door open for 6 years
had your color TV turned on for 28 years
kept a bathroom light burning for 30 years