A Father's Crusade: The Dangers of the Abortion Pill Mifeprex
Pills and Politics
By the time Patterson began his research, approximately 250,000 women in the United States had used mifepristone to end pregnancies, though the majority of women having abortions still chose vacuum aspiration, which is faster and often less painful. (Mifepristone has been called the "abortion pill," which makes it sound like a quick fix, but the reality is that it can cause a week or more of serious cramping and bleeding.) Battle lines over the drug were drawn. To pro-choice advocates, medication abortion was appealing because it could be performed very early -- in fact, it's recommended only up till seven weeks. (Some studies have found it to be effective for up to nine weeks.) But even more important, it was private: Women could abort at home, without the risk of being seen in public going to an abortion clinic -- thereby escaping the picketing and threats of violence that had become so common. It also was a safety net in case surgical abortion became unavailable: Between 1992 and 1996 the number of providers in America had declined by 14 percent.
What drew Patterson's attention to abortion opponents, who were against the drug on principle, was their view that the drug was unsafe. In August 2002, Concerned Women for America, a Washington, D.C.-based group whose stated goal is to "bring biblical principles into all levels of public policy," the American Association of Pro-Life Obstetricians and Gynecologists, and the Christian Medical Association joined forces to file a petition asking the FDA to stop distribution and marketing of mifepristone. Among their claims: that the FDA had rushed its approval of the drug by placing it in an accelerated approval program meant only for medications that treated life-threatening illness and that it had not been tested specifically on adolescent girls, though they would almost certainly use it. The coalition also said that the drug regimen being used in U.S. clinics was not what the FDA had approved. In order to give patients a lower dose of mifepristone, many providers were having them insert the misoprostol themselves at home, vaginally, rather than take it orally at the clinic.
Some of these allegations were disputed. Danco pointed out that approval of mifepristone wasn't granted for more than four years after the application was initially submitted, hardly a rush. And Planned Parenthood said that while it was true the regimen had been changed, studies and clinical practice had shown this method not only was safe but also preferable -- taken orally, misoprostol nauseated a lot of women.
But in April 2002, both Danco Laboratories and the FDA had acknowledged some real problems with the drug. A small number of women had suffered ruptured ectopic pregnancies after mifepristone was used (inappropriately) for termination; one of them had died. In addition, a young woman with a family history of heart disease had suffered a nonfatal heart attack and two women had developed bacterial infections. One of those women, a 26-year-old participating in drug trials in Canada, had died (Canadian drug trials were halted afterward). And it wasn't at all clear that that was all. It's voluntary for physicians to report a patient's bad drug reaction to the FDA; moreover, when complications occur days afterward the connection isn't always made. The FDA itself has estimated that no more than 10 percent of all adverse drug effects are ever reported.