The Abortion Pill's Grim Progress
News: Anti-abortion protesters, gun-shy drug companies, and timid politicians have stymied RU 486 for a decade. This year, all that may change.
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In 1988, Mother Jones announced a "birth control breakthrough" on its cover, describing the development of a promising new "abortion pill"—RU 486—and asking why, if it worked so well for French, Chinese, Swedish, and Dutch women, it wasn't available in the United States. The physicians, feminists, and family-planning experts I interviewed then predicted that, given the political climate surrounding abortion, it could be 10 years before RU 486, or mifepristone, would be approved for use by American women.
Eleven years later, U.S. doctors still can't prescribe the drug. But if all goes smoothly, they may get to sometime this year. The FDA has given mifepristone preliminary approval, and, equally significant, manufacturers have been identified. Don't hold your breath, though: Formidable political obstacles have long kept mifepristone from pharmacy shelves, and plenty more could arise.
If and when mifepristone does become available, it will remove many of the political and practical barriers that have made it difficult for U.S. women to get abortions—and for many physicians to perform them. A survey of physicians conducted by the Kaiser Family Foundation and published in September found that 54 percent of all obstetricians and gynecologists, including 45 percent of those who don't currently perform abortions, said they would offer mifepristone if it were available.
The greatest victory of the anti-abortion movement has been to move a straightforward procedure out of the medical schools, out of the hospitals, and into freestanding, sitting-duck clinics. Mifepristone's promise is that it can bring abortion back into the mainstream and into the hands of the family physician or small-town gynecologist. In a country where 86 percent of counties have no known abortion providers, there's no doubt mifepristone would make abortion more accessible. "We're talking about expanding the pool of providers from literally a handful to many, many, many," says Eric Schaff, an associate professor at the University of Rochester, who is conducting clinical trials of mifepristone.
It isn't as if mifepristone will completely defuse the abortion controversy. Even if the drug is approved, many women will still need surgical abortions. Mifepristone works early by blocking the hormone progesterone from reaching uterine cell receptors. Without progesterone, the uterine lining can't grow and nourish the fertilized egg, which then detaches. A day or two later, women take a second drug, misoprostol, a prostaglandin that causes the uterus to contract, expelling its contents as in a normal menstrual period. The procedure works best within seven weeks of the woman's last period. In the United States, more than half of all abortions—or 736,000 per year—are performed by nine weeks, according to the Alan Guttmacher Institute, which tracks abortion statistics. It isn't clear how many of these women would choose a medical abortion over a surgical one-but one can guess. "All we know," says Heather O'Neill of the Danco Group, which is seeking to market the drug, "is that, given the option, one-third of French women chose to have a medical abortion."
Women who have tried mifepristone have been satisfied with the results, saying they find it less physically and emotionally invasive than surgery. Ninety-six percent of women in one U.S. clinical trial said they'd recommend the medication to others who needed an abortion, according to a study published in the Archives of Family Medicine. Of the women who had also experienced a surgical abortion, three-quarters preferred the drug. Even among women for whom the drug failed (8 percent at the seven-week mark in one clinical trial), 70 percent said they'd try it again if needed. The procedure isn't without side effects— including nausea, vomiting, headaches, and diarrhea—but it is remarkably safe. Among the estimated 2 million women who have used mifepristone worldwide, there has been only one reported death, and that was due to a type of prostaglandin no longer in use, not mifepristone. Currently, an estimated 80,000 women die annually from botched abortions around the globe.
Once approved, mifepristone will likely have many other uses. Numerous studies have proved it safe and effective, and have suggested it may be helpful in treating other women's health concerns, such as endometriosis, fibroid tumors, difficult labors, and a type of brain tumor. Most of those studies have stopped as researchers have run out of the drug, but will continue once it's available again.
Despite mifepristone's likely popularity, the anti-abortion movement has succeeded in keeping it off the U.S. market. Since 1982, when researchers for the French company Roussel Uclaf reported that the drug could terminate pregnancy, abortion foes have worked on several fronts to stop it. In 1988, when the French minister of health approved the general use of the drug, opponents assailed RU 486 as a "chemical weapon" against the unborn. They organized protest marches through Paris and temporarily succeeded in getting Roussel to withdraw the pill from the market. The French government, which owned 36 percent of Roussel, muscled it back (hailing it as the "moral property of women"), but Hoechst, the company's parent—which had about $7 billion in annual pharmaceutical sales in the United States and a devout Catholic president—was daunted by the possibility of similar boycotts here.
Feminist groups, particularly the Feminist Majority Foundation, lobbied Roussel to bring RU 486 to the United States, but to no avail. In 1990, the American Medical Association argued that the drug should be made available in the United States on the grounds that an equally effective noninvasive procedure is always preferable to a surgical one. Conservative Republicans, however, kept pressure on the Bush administration to ban the drug's introduction.
With Bill Clinton in office, things began to give. In 1993, Clinton issued an executive memorandum to Health and Human Services Secretary Donna Shalala to investigate possibilities for bringing mifepristone into this country. Then, in 1994, Roussel Uclaf donated the U.S. patent rights for mifepristone to the Population Council, a nonprofit research group, which promptly began a clinical trial. In 1996, reviewing the data, the FDA issued qualified approval of the drug, pending information on labeling and manufacturing.
But finding a manufacturer has also proved difficult. Pharmaceutical companies were largely unwilling to take on a relatively small-revenue drug that carries a high risk of political fallout—and not just from anti-abortion protesters. Several mutual funds with anti-abortion agendas have said they will exclude manufacturers of mifepristone from their portfolios. "If we invest in companies," says Frank Rauscher, CEO of the Aquinas Funds, "we want to make sure the companies are involved in ethical and legitimate activities." He adds that Merck, Johnson & Johnson, Schering-Plough, Pharmacia & Upjohn, and Pfizer have all told him they will not manufacture the drug.
Last year, the Population Council licensed the Danco Group to market mifepristone. Danco has, at long last, found manufacturers—which it would not identify—willing to do the job. "We expect to make [mifepristone] available to women in the U.S. sometime in 1999," says the Danco Group's O'Neill.
Regardless of when the drug is approved, the trend toward earlier, more accessible abortions seems clear. Several Planned Parenthood clinics now offer abortions induced with methotrexate—a cancer drug that works more slowly than mifepristone and is not approved by the FDA as an abortifacient. Also, more physicians are offering earlier, less invasive surgical abortions, using manual suction techniques and a syringe instead of a machine vacuum. "Regardless of how soon mifepristone becomes available," says Paul Blumenthal, medical director for Planned Parenthood of Maryland, "women will have more choices for terminating an unwanted pregnancy."
Still, it may not be smooth sailing. Last year, Rep. Tom Coburn (R-Okla.) added an amendment to an agriculture bill that would have kept the FDA from using any funds to approve an abortifacient; Republicans also tried to block the confirmation of FDA Commissioner Jane Henney because of her supposed support of the drug. Though both efforts were dropped, there's no telling—despite the success of pro-choice candidates in the fall elections—what else will materialize. In part, the fate of mifepristone lies in the hands of women who believe that a medical abortion should be a matter of choice.
