In the privacy of her doctor's office, a woman takes mifepristone, also known as RU-486, to end a pregnancy of nine weeks or less. She returns two days later for misoprostol, waiting in the office till contractions expel the fetus. As with a
miscarriage, she experiences bleeding and cramping. Twelve days later, she returns for a check to make sure the medical abortion is complete.

No long drive from home to reach an abortion provider. No gauntlet of shouting protesters. No surgery.  No wonder anti-abortion activists have fought for 12 years to make RU-486 unavailable to American women.

In February, four years after declaring RU-486 to be safe and effective, the U.S. Food and Drug Administration said it would approve its use.  With restrictions.

Last week, the U.S. manufacturer, Danco Group, revealed what the FDA is considering:

Only doctors qualifies to perform surgical abortions who practice within an hour's drive of an emergency room could provide RU-486.  The doctor's names would appear on a registry -- creating a ready-made hit list for anti-abortion fanatics.

The FDA hasn't made anything official.  The final rules are due Sept. 30.

"There's no medical reason" for the restrictions, says Elizabeth Newhall.  As medical director of the Women's Health Center in Portland, Oregon, she conducted clinical trials of mifepristone and misoprostol.  "This is a very safe drug, a very effective drug, " says Newhall.  "There's no lack of data.  This is not about medicine."

What is it about?

Anti-abortion crusaders have failed to make abortion illegal, but they're succeeding at making it unavailable -- especially to women in rural areas.

The number of doctors doing surgical abortions is declining.  Many medical schools don't provide training in surgical abortion.  Some experienced doctors aren't willing to face death threats.  As a result, there is no abortion provider in 86 percent of countries.

The campaign against RU-486 has been fierce because it would expand access and restore privacy.

Only one quarter of gynecologists perform abortions, according to a survey by the Kaiser Family Foundation.  Of those who don't, a third say they'd provide RU-486 if it were legal.  In addition, a third of family practice physicians say they'd be likely to use it.

But if there's a registry, no doctor will want to be on it.

The FDA requires a doctors' registry for only one drug: thalidomide.  Notorious for causing horrible birth defects in the '60's , thalidomide is being used primarily for treatment of cancer patients.  As a very high risk drug, its use is strictly controlled.

RU-486 is not risk free.  No drug is.  But is has a better safety record than many other drugs that can be prescribed by any medical specialist, without dire warning labels.

Consider Viagra, blamed for dozens of fatal heart attacks in the brief time it's been on the market.  Optometrists, dermatologists and gynecologists can prescribe Viagra to eager octogenarians, no matter where the nearest emergency room is located.

In the past 12 years, half a million European women have used RU-486 to end an early pregnancy.  Early on, a Frenchwoman in her late 30's, a heavy smoker, had a fatal heart attack after receiving an injectable prostaglandin as the follow-up to RU-486.  Doctors stopped using injections, and later switched to misoprostol; no further cardiac problems were reported.

As the drug was adopted in Europe and Asia, anti-abortionists vowed to boycott any company that made it available in the U.S.   So the French manufacturer gave U.S. marketing rights to the non-profit Population Council, which conducted clinical trials proving it's just as safe for American women as it is for women abroad.

The complication rate is very low, says Newhall.  Only 1 out of 3000 women needs help for excessive bleeding.  "It's the same clinical picture as miscarriage," she says, and can be treated by any doctor who knows how to handle miscarriage.

About 2-4 percent of the time, the fetus isn't completely expelled, so surgical evacuation is required.  That sometimes is necessary in miscarriages, too.

Despite the bleeding, women in clinical trials, said they were very satisfied with the procedure in a follow-up survey, reports Marie Harvey, a public health professor at University of Oregon and an associate at the Pacific Institute for Women's Health in Los Angeles.  More than 94 percent of women said they'd recommend it to a friend who was seeking an abortion.

Because of the long wait for RU-486, some U.S. doctors have been prescribing methotrexate, a FDA approved cancer drug, to women seeking a non-surgical abortion.  Once a drug is approved, doctors can prescribe it for "off-label" uses.

Women also are satisfied with methotrexate, says Harvey.  But the drug isn't used for abortion in any other country.  They've got something better:  RU-486.

American women should have that choice, too.

© 2001 The Mercury News