Counteroffensive on RU-486
Critics allege safety concerns overlooked in FDA approval process
Stan Guthrie | posted 6/11/2001 12:00AM
Mark Louviere, a physician in Waterloo, Iowa, is not likely to forget the events of November 29, 1994. He was on call when the emergency room staff of Allen Memorial Hospital paged him. When Louviere arrived at the ER, he immediately examined a woman who had a racing pulse. Her body was in shock with dangerously low blood pressure. But it was her massive loss of blood that received the ER team's urgent attention. The woman was severely hemorrhaging from what appeared to be either a botched surgical abortion or a miscarriage.It was neither. The patient's husband quickly informed Louviere that she was part of a clinical trial of RU-486, the French abortion pill, through Planned Parenthood in Des Moines. The woman had lost over half of her blood, and Louviere immediately took her into surgery for treatment. After two days of recovery and the transfusion of four units of blood, the woman went home, shaken, but with no long-term complications.
Such rare but harrowing cases may decide the final fate of RU-486, which the U.S. Food and Drug Administration (FDA) approved last fall as "safe and effective." While the sole American distributor, Danco Laboratories, reports heavy initial demand, abortion-pill critics seek to impose distribution restrictions that the FDA examined but declined to adopt. Ultimately, they hope that the new administration of President Bush, which is sympathetic to prolife concerns, will halt the drug's use over safety concerns.
"Regardless of whether you're prochoice or prolife, there are some significant public-health concerns related to the approval and use of this," says W. David Hager, M.D., director of the Women's Care Center of Lexington, Kentucky, and a professor in the Department of Obstetrics and Gynecology at the University of Kentucky.
On the Fast TrackAfter years of opposition from prolife groups, the FDA last September approved RU-486 for ending pregnancies with gestations of no more than 49 days. In the United States, RU-486 is now called Mifepristone or Mifeprex (its trade name). RU-486 was approved for use in France—where it was developed and manufactured—in 1988, in the United Kingdom in 1991, and in Sweden in 1992. More than 600,000 women have used it worldwide.In May 1994, while secretary of the U.S. Department of Health and Human Services, Donna Shalala encouraged Roussel-Uclaf, the French firm that had developed Mifepristone, to donate the U.S. rights to the Population Council. Clinical trials of 859 American women, including the woman in Iowa, occurred in 1994 and 1995.
The Population Council, a New York-based nonprofit organization focusing on reproductive and population issues, initially sought the FDA's imprimatur in March 1996. The agency granted conditional approval later that year. It wasn't until the waning days of the Clinton administration, however, that the FDA gave its official approval to Mifepristone under an "accelerated approval" process involving shorter studies than for most drugs. The accelerated approval process was designed to streamline the introduction of new drugs that fight life-threatening disease or illness. Not until RU-486 had it been used in connection with a normal condition. Accelerated approval includes careful follow-up studies and provisions to limit the drug's distribution.
Several snags delayed the approval process, including the Population Council's delays in submitting results of the clinical trials and difficulty in finding an overseas manufacturer for the abortion pill. (No American drugmaker was prepared to weather the prospects of prolife protests and boycotts.)
June 11 2001, Vol. 45, No. 8
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