ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Saturday, July 20, 1996 TAG: 9607220068
SECTION: NATIONAL/INTERNATIONAL PAGE: A-1 EDITION: METRO
DATELINE: GAITHERSBURG, MD.
SOURCE: Associated Press
NOTE: Below
Scientific advisers recommended Friday, with some conditions, that the controversial drug RU-486 become the first approved alternative to surgery for American women who have abortions.
The decision puts the French drug, which has been taken by 200,000 European women since 1988, a step closer to U.S. doctors' offices - but it came with certain caveats.
The scientists warned that women must understand RU-486 can be painful, cause bleeding and must be used carefully - requiring three separate exams by the woman's doctor.
``The term `safe' should not be misinterpreted as free of adverse events, and serious adverse events,'' said Dr. Diana Petitti of Kaiser Permanente Medical Care Program in Pasadena, Calif.
Still, as abortion foes protested, the advisers voted 6-0 with two abstentions that RU-486's benefits outweigh its risks, a recommendation that the Food and Drug Administration approve the drug.
If final analysis of a study on 2,100 American women, not yet complete, turns out differently from the French data on which the panelists based the decision, they have a chance to review the research again.
Abortion foes had urged the FDA's advisers to reject the drug, saying it endangered not just fetuses but mothers. But research on thousands of French women showed RU-486 causes an abortion 95.5 percent of the time, with rare complications.
The FDA is not bound by advisory panel decisions but usually follows them. FDA commissioner David Kessler said he hoped to make a decision on RU-486 within two months, but would not say which way he is leaning. ``It's fair to say there were certain strong and intense feelings'' expressed on RU-486, but ``the scientific portions of this meeting were no different today than at any other advisory committee.''
One panelist, who abstained from the vote, agreed with anti-abortion groups. The drug may benefit women ``but it's certainly no benefit to her baby whatsoever,'' argued Dr. Mary Jo O'Sullivan of the University of Miami.
``RU-486 is a human pesticide,'' said Rebecca Lindstedt of the American Life League. Outside the hearing, blocked by a line of police cars, a handful of protesters picketed with signs reading ``Stop Abortion Now.''
Countered Dr. Elizabeth Newhall, who tested RU-486 on 176 Oregon women as part of trials by the nonprofit Population Council: ``Abortion is not on trial here. A drug that offers a safe and effective alternative is.''
RU-486, known chemically as mifepristone, is 95.5 percent effective when used in the earliest weeks of pregnancy - 49 days from conception, according to studies of 2,480 French women.
A woman must take three tablets of RU-486, which blocks the development of a natural hormone essential for maintaining pregnancy.
Two days later, she takes two more pills, this time a hormone called misoprostol. Misoprostol causes uterine contractions to expel the embryo. Women experience contractions and bleeding strong enough they must stay in the clinic for four hours to ensure they are well. The vast majority will expel the embryo within 24 hours; for 8 percent of women, that could take a few more days.
A third exam is required to ensure the abortion worked. If not, the woman needs a surgical abortion, because continuing the pregnancy could risk bearing a malformed child.
Of 200,000 European women who have taken RU-486, 21 children have been born - one who had deformities so bad the baby died and two others with mild limb defects, said Population Council's Dr. Wayne Bardin.
While acknowledging that RU-486 is painful, the Population Council compared it to a miscarriage, not the intense pain of labor.
``Medical abortion felt more natural and less invasive than the surgical procedure,'' agreed Marie Head of Atlanta, who had an RU-486 abortion a year ago in Atlanta in a test case, and had a surgical abortion 10 years earlier. ``I felt like I had a heavy menstrual flow.''
But anti-abortionists say women could bleed to death from RU-486, citing a woman in Iowa who bled for two weeks before seeking hospital help.
That's rare, the Population Council insisted. Of the 2,480 French women tested, only four bled badly enough to need blood transfusions - as did another four in extra safety testing of 2,100 U.S. women. Thirty-two other Americans had minor surgery to stop heavy bleeding.
Almost all of the nation's 1.3 million abortions are surgical, although doctors last year began publicizing that a drug already on the market to treat cancer - methotrexate - can be used to induce abortion. RU-486, however, would be the first FDA-approved abortion drug.
LENGTH: Medium: 87 linesby CNB