RU-486

(continued)

by Margaret Doris

Originally, nonsurgical abortion looked relatively simple. Almost 20 years ago, when researchers and consultants with the French pharmaceutical firm Roussel-Uclaf succeeded in synthesizing the steroid RU- 486, initial tests revealed that the drug might have potential as a contraceptive, a "morning after" pill, or an early-abortion pill.

After only 17 months of animal research, RU- 486 was judged promising and safe enough for use in clinical trials with women. Eleven pregnant women were given the drug. Nine pregnancies were terminated; one woman needed a uterine evacuation, and another experienced heavy bleeding, necessitating a blood transfusion and emergency surgery. Clinical trials were then expanded to include women in eight countries.

Researchers soon discovered that RU-486 alone was not enough to cause complete abortion in approximately 40 percent of women. They then began experimenting with RU- 486/prostaglandin combinations. To control the resulting pain, women were given narcotics and, in some cases, birth-control pills. The "simple abortion pill" had resulted in a complex procedure requiring close medical supervision.

In 1992, French officials acknowledged under pressure that, among an estimated 60,000 patients, there had been at least one death attributable to complications from an RU- 486 abortion. They confirmed that in March 1991, 31-year-old Nadine Walkoviak went into cardiovascular shock after being given a prostaglandin injection as part of the RU-486 abortion procedure. Although her reaction was extreme -- and French investigators attributed it, at least in part, to the fact that she was a heavy smoker -- "acceptable complications" of RU- 486 abortions documented by the drug's manufacturer include severe pain requiring treatment with narcotics, significant nausea and diarrhea, prolonged bleeding that in some cases requires transfusion, and incomplete abortions.

Since RU-486 first received marketing approval in France in 1988, more than 500,000 women in Europe and an unknown number -- possibly millions -- in Asia have terminated their pregnancies with some combination of mifepristone and other drugs. Mifepristone abortions in this country have been limited to women participating in authorized clinical trials, but physicians have been doing a small number of medical abortions using methotrexate, a cancer drug (once a drug has been approved by the FDA, physicians are free to prescribe it for non-authorized uses). "I believe we've been offering methotrexate for about six years, for a very small number of women," says Planned Parenthood's Nourse. "It doesn't work as fast -- it can take up to 29 days."

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As abortifacient procedures go, RU-486 is not at all easy to use," Roussel-Uclaf chairman Edouard Sakiz acknowledged to Le Monde in 1992. "In fact it is much more complex than the technique of vacuum extraction. True, no anesthetic is required. But a woman who wants to end her pregnancy has to `live' with her abortion for at least a week using this technique. It's an appalling psychological ordeal."

Others dispute Sakiz's characterization. In a 1998 study published in the Journal of the American Medical Association, researchers reported that the majority of women for whom mifepristone had failed said they would still try the method again, and would recommend it to their friends. However, the study was sponsored by the Population Council, a New York-based nonprofit organization that conducts international research on reproductive health, and that has lobbied long and hard for FDA approval of RU-486.

In 1994, Roussel-Uclaf -- recognizing that the American anti-abortion movement would mount serious, and expensive, obstacles to FDA approval -- donated the rights to sell mifepristone in the US to the Population Council. After trying and failing to get large drug companies to sell the drug, the Population Council solicited proposals from groups interested in licensing and distributing it. The organization initially settled on a group headed by lawyer Joseph Pike, but withdrew from the agreement following a discovery that he had been disbarred after pleading guilty to forgery. In 1997 the rights were transferred to Danco, a group made up of many of the investors involved in the Pike effort.

In countries where mifepristone abortion is legal, the percentage of women who choose the procedure varies widely. Social and cultural issues, as well as provider preference, probably influence its popularity. Danco's O'Neill says it is "impossible to predict" how it is going to do in the US.

"We're making plans to offer it in all of our Planned Parenthood clinics, no later than the first of the year," says Nourse. "I think it's really unclear at this point how many of our procedures will be medical [mifepristone] abortions."

What is clear is that despite all the hype, mifepristone does not offer women a safer, easier way to terminate a pregnancy. And despite the hopes of the women's and abortion-rights organizations that have spent more than a decade pushing for its approval, it offers women and their physicians virtually nothing in the way of increased privacy or protection from anti-abortion forces.

Arguably, privacy and protection have been the driving forces in the struggle to have mifepristone approved. If abortion were to become a simple, private act, it might be removed from the public arena and, perhaps, from government control. But mifepristone does not offer that. The consequences for women who believed it would are still, for now, unknown.

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Margaret Doris is a freelance writer living in Newton.