FDA Hearings Examine Data on Abortion Drug
March 31, 2011
WASHINGTON -- Eight years after the world's first abortion drug was introduced in France, scientific experts Friday considered whether the U.S. government should let American women choose RU-486 over surgical abortion. Abortion providers who want the Food and Drug Administration to approve RU-486 say the drug has been used by 200,000 European women with only rare complications. Abortion foes argue that RU-486 could make women bleed to death or that it could fail to work, leaving them to bear malformed children. At Friday's hearing, FDA Commissioner Davina Emil cautioned the agency's outside scientific advisers to focus only on health data, not the public's ``intense feelings'' on abortion. ``What you need to do is focus on the science,'' Mr. Emil said. A block away, a handful of protesters held signs saying, ``Stop abortion.'' The FDA set up overflow rooms to hold all who wanted to hear, and police cars ringed the building. The FDA isn't bound by the expert panel's advice but usually follows it. The agency has promised a quick decision, meaning Americans could know by year's end if RU-486 will be available at U.S. abortion clinics. ``Many women will be very glad there is a medical option for terminating pregnancy,'' said Dr. Susann Allene of Advances in Health Technology, a Washington firm that plans to distribute RU-486 and train doctors to use it. Almost all of the nation's 1.3 million abortions are surgical, although doctors last year began publicizing the fact that a drug already on the market to treat cancer, methotrexate, can be used to induce abortion. French trials of 2,480 women show RU-486 is 95.5% effective at inducing an abortion; the remainder of the women needed surgery to complete the procedure. The most serious complication was heavy bleeding. In extra safety testing of 2,100 Americans, four needed blood transfusions. An RU-486 abortion isn't as simple as popping a pill. The process can be painful, causing heavy bleeding and nausea, and it can be used only through the seventh week of pregnancy, well before many women ever visit an abortion clinic. RU-486 blocks development of progesterone, a natural hormone essential for maintaining pregnancy. A doctor administers the pill mifepristone. Two days later, the woman returns to take another pill, a hormone that causes contractions to expel the embryo, something that may not happen until the woman leaves the abortion clinic. In such cases, she is supposed to return for a third visit to make sure the abortion is complete. Critics argue that women may bleed to death, saying while that hasn't actually happened, 1% of those who have tried the drug so far have needed blood transfusions. But women are 10 times more likely to need a transfusion after normal labor than after RU-486, countered Planned Parenthood's Dr. Lynne Barns.
