THE VIRGINIAN-PILOT
Copyright (c) 1996, Landmark Communications, Inc.
DATE: Saturday, July 20, 1996 TAG: 9607200217
SECTION: FRONT PAGE: A1 EDITION: FINAL
SOURCE: FROM WIRE REPORTS
LENGTH: 92 lines
RU-486, the controversial ``abortion pill,'' is safe and effective and should be made available to American women, an advisory panel of the Food and Drug Administration concluded Friday.
Seven of eight voting members of the FDA's Reproductive Health Drugs Advisory Committee voted that the medical abortion method was safe for use in the United States, although they warned that ``safe'' is not the same as ``risk-free.''
The scientists said women must understand RU-486 can be painful, cause bleeding and must be used carefully - requiring three separate doctor exams.
The FDA is not bound by the recommendations of its advisory committees, but usually follows them. FDA Commissioner David Kessler said after the meeting that the panel had given him ``a very strong signal'' that the drug should be approved, and added, ``We take that advice very, very seriously.''
RU-486, or mifepristone, is an antiprogestin, one of a family of drugs that blocks the action of the hormone progesterone, needed to maintain pregnancy. If approved, it would be administered in two stages. Patients who have been pregnant for less than 49 days would take a 600-milligram oral dose of mifepristone one day, and return two days later for a 200-microgram dose of misoprostol, a ``prostaglandin'' drug already approved by the agency that triggers uterine contractions. The combination induces an abortion without surgery.
Most abortions occur within four hours of taking misoprostol. The regimen outlined in the application calls for the patient to spend those four hours in the clinic or doctor's office, and also includes monitoring after the fact. The treatment is expected to cost several hundred dollars.
In French and American studies, the drug combination is successful in 95 percent of cases. Women in whom it fails should have a surgical abortion, because the drugs might cause birth defects, said representatives of the Population Council, the New York-based research organization that applied for the drug's approval.
Mifepristone was developed by French researchers in 1980 and approved in France in 1988. Nearly 200,000 women have had medical abortions using the drug in France, the United Kingdom and Sweden and other countries. Twenty-one births have been reported after unsuccessful medical abortion attempts. Three of those children were born with birth defects: one with a club foot, one with ``abnormal fingernails,'' and one with an immune system deficiency that proved fatal.
Because mifepristone could constitute an advance over existing therapy, the FDA considers it a ``priority drug'' and has a statutory goal of acting on the application within six months.
The panel reviewed data from two French clinical trials that enrolled 2,480 women, and an American trial with 2,121 women, conducted as part of the application for U.S. approval. The American data, however, were preliminary and have not been thoroughly verified or reviewed.
In all three studies, the drug combination produced abortions in at least 95 percent of cases. Patients experienced side effects including cramps, nausea, and vomiting - symptoms also common to miscarriage and abortion. As many as 82 percent of patients reported painful contractions; as many as 30 percent reported that their symptoms were ``severe.'' More infrequent side effects included headache, dizziness and, very rarely, heart palpitations and toothache.
Wanda Franz, president of the National Right to Life Committee, expressed disappointment in the advisory committee vote. ``Unfortunately, the committee, which was stacked with abortion supporters, brushed aside serious health concerns for women who take this drug,'' Franz said.
One FDA 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.
Proponents of the drug's approval said that surgical abortion is safe, but insisted the medical alternative could be safer still - and not just in medical terms. Susan Hill of the National Women's Health Organization, recounted working with colleague David Gunn, the doctor shot and killed in 1993 for his work performing abortions. Approval of a medical option, she said, could ``stop the ghettoization of abortion providers'' and provide greater privacy for patients.
If approved by the FDA, the drug would be sold by Advances in Health Technology, a nonprofit organization created late last year to market this and future reproductive drugs. A representative of AHT said the drug could be available next year.
The Population Council estimates that a patient's cost for the abortion, including follow-up visits, would be around $200 - about the lower-end cost for a surgical abortion. MEMO: This story was compiled from reports by The Washington Post,
Knight-Ridder News Service and The Associated Press.
ABOUT RU-486
Since 1988, RU-486, the abortion pill developed in France, has been
used by more than 200,000 women in Europe to terminate pregnancies. Some
advocate the drug as an important option for women who want to avoid
surgery or who desire an abortion at a very early stage of pregnancy
before surgical abortion is medically feasible. by CNB