One of the most tendentious and unproductive battles to divide this country in the last 30 years could cool down considerably if the U.S. Food and Drug Administration would make the abortion pill RU 486 available to American women.
Women in much of Europe have had it for more than a decade, and it recently became available in Spain, the Netherlands, Australia and Israel. For American women to be denied access to a nonsurgical method of early abortion is simply unconscionable. It's bad medicine, bad science and venal politics.
RU 486 (also known as mifepristone) is given to a woman up to the 49th day of pregnancy in most countries (the 63rd day in Sweden and the United Kingdom) and blocks growth of the placenta. That is followed in 24 to 72 hours by a second drug, misoprostol, which triggers contractions. The combination was deemed "approvable," in terms of safety and efficacy, four years ago by the FDA, and abortion rights activists have been lobbying for it to be made available ever since. It has been used by more than 500,000 women around the world, with only a small percentage of women reporting excessive bleeding or other complications.
In the United States, however, RU 486 has become a hostage in the abortion war, with anti- choice activists determined to keep it out of the hands of American women. A chief mischief-maker on this front has been Rep. Tom Coburn (R-Okla.), an obstetrician, who has succeeded twice in attaching a rider to the House version of the agricultural appropriations bill that forbids the FDA from testing, developing or approving "any drug for the chemical inducement of abortion." The amendment passed the House by three votes last year, but was dropped in the conference committee. The House is expected to revisit the question very soon.
"My feeling is it's absolutely critical that we work as hard as we can to defeat it," says Rep. Nita M. Lowey (D-N.Y.), who has been a leader in the fight against the rider. "In France, the minister of health called it the moral property of women. The FDA should be able to do its job free from right-wing intimidation. What [the amendment] would do is deny women a safe, effective, early and private option.
"It would also stop dead in its tracks the research that's begun on RU 486 for other uses. For example, it's been tested as a therapy for breast cancer, metastatic prostate cancer, benign brain tumors, Cushing's syndrome, the induction of labor, and fibroid tumors. What's most important is the federal drug approval process must be based on science, not politics."
Another threat to the availability of RU 486 came this month when the FDA proposed making the treatment available in the United States with restrictions that paralyze the mind. These include a certification process for all doctors prescribing the drug, which means a list, which means those doctors would be exposed to the same homicidal lunatics who have attacked abortion clinics. Such a list could carry all the top-secret stamps in the world and it would still get out. If we can't keep nuclear weapons secrets at Los Alamos, it's a pretty safe bet we can't keep a list of doctors at the FDA secret.
Under the FDA proposal, doctors prescribing the drug would have to have privileges at a hospital within one hour of their offices, and only doctors trained in providing surgical abortions would be allowed to prescribe the drug. The number of doctors who meet that last requirement has been steadily diminishing. Many have given up performing abortions because of the anti-abortion terrorists.
The FDA declined to give the reasons for the restrictions, offering the usual mealy-mouthed quotes of an anonymous spokesman who talked about how "we also focus on how a product can be used safely." At this point, the agency is involved in discussions with the New York-based Population Council, a private nonprofit family planning research group, which has U.S. rights to the drug, and with Danco Laboratories LLC, which has the right to manufacture and distribute the drug here.
Advocates who want to make RU 486 widely available to American women hope to persuade the FDA to take a more reasonable stance. All parties seem to agree that providers need specific training in how to administer this drug, counsel patients on its use and provide surgical backup in case there are complications or the drug fails to work, which happens in about 5 percent of cases.
It is absurd for American women not to have access to this drug when other women around the world do. Underscoring the folly is that we already have a "chemical inducement of abortion," and it is used in clinics around the country. It's called methotrexate, and it was approved for use as a chemotherapy agent by the FDA in 1953.
Once a drug is approved for one use, physicians can use it for other "off-label" treatments. It has been used to induce thousands of abortions in recent years, although most women do not know of its availability.
RU 486 would be preferable to methotrexate because it is 95 to 97 percent effective, compared with 90 to 92 percent effective for methotrexate, and it acts much more quickly and predictably, according to George Huggins, a professor of obstetrics and gynecology at Johns Hopkins University, who chairs the Planned Parenthood of America Federation.
Gloria Feldt, president of Planned Parenthood, predicts the approval and availability of RU 486 will be comparable to the arrival of the birth control pill 40 years ago. It will give women an early, private and safe way to terminate a pregnancy and help return this decision to a woman and her doctor.
Then this country can start putting this awful abortion fight behind us.