New Pill Ends 85% of Early Pregnancies, French Report
In a breakthrough with profound social implications, French researchers reported today that an experimental pill could be safely used to terminate 85% of early pregnancies.
If taken within days of a missed menstrual period, the drug can cause the uterus to expel the fertilized egg, according to a report in the New England Journal of Medicine.
The compound, known as RU 486, works by blocking the action of the sex hormone progesterone, which is necessary for the development of the fetus and its attachment to the uterus.
“This is an exciting new breakthrough,” said Dr. Wayne Bardin, director of the Center for Biomedical Research of the Population Council in New York City. “It is the most effective drug for the early termination of pregnancy.”
The drug could provide a potential alternative to many of the 40 million to 50 million abortions performed worldwide each year. In addition to offering increased privacy, the pill would eliminate potential complications associated with abortions, such as anesthesia, infection and psychological trauma, the researchers said.
In an editorial accompanying the journal report, Dr. William Crowley of the Massachusetts General Hospital noted that the drug would “at once provide new options, yet force further difficult choices, onto a society already bitterly divided about the medical termination of pregnancy.”
One of its drawbacks is that it can cause heavy bleeding, they said. The drug also is less effective later in pregnancy.
There are other experimental drugs that terminate pregnancy, such as prostaglandins. These drugs cause contractions of the uterus, but the pain often associated with these contractions may limit their usefulness.
RU 486 also is undergoing tests in this country--at the USC School of Medicine; University of California, San Diego; Eastern Virginia Medical College, and the Population Council.
“Very early in pregnancy it is medically safer for a woman to take this pill than to have a surgical termination of pregnancy,” according to Dr. Daniel R. Mishell Jr. of USC, who has tested the drug on about 150 patients.
The drug’s manufacturer, Roussel-UCLAF of Paris, is expected to seek marketing approval for RU 486 as a prescription medicine in France next year.
Despite the potential benefits, Roussel-UCLAF has no plans to seek approval for the drug in the United States, Mishell said. This is largely because of the anticipated strong objections from anti-abortion groups.
“We are not opposed to contraception, but we would strongly oppose the marketing of a drug which would terminate pregnancy no matter how early it was,” said Mark DeMoss, a spokesman for the Rev. Jerry Falwell’s Liberty Federation in Lynchburg, Va.
The French study, conducted at the Bicetre Hospital in Bicetre, involved 100 women who were seeking abortions. They were treated with various doses of the medicine within 10 days of missing a menstrual period.
The drug induced uterine bleeding in all of the patients within four days, and the bleeding continued for an average of 11.6 days, or comparable to the amount of bleeding in a heavy but painless menstrual period, the report said.
But follow-up tests confirmed expulsion of the developing embryo in only 85% of patients; the others required surgical abortions.
Side effects included abnormally heavy bleeding in 18% of the patients who responded to the medicine and painful uterine contractions in 26% of these patients.
Researchers have thought for nearly 20 years that anti-progesterone drugs might have many medical uses. But no such compounds exist in nature, according to Bardin.
It was not until the early 1980s that Dr. Etienne Emile Baulieu, one of the authors of the new French study, synthesized RU 486. It is the first in a series of such drugs that have subsequently been discovered.
RU 486 differs from so-called morning-after pills, which are effective in terminating possible pregnancy only if taken within 72 hours of sexual intercourse. These drugs are usually nothing more than large doses of birth control pills, and they work by interfering with the initial attachment of the fertilized egg to the uterus.
Currently, all of the several hundred patients in the United States who have received RU 486 have been studied extensively with medical exams, blood tests and ultrasound studies, under strict protocols approved by the U.S. Food and Drug Administration.
In the future, researchers hope that such extensive evaluations will be unnecessary; indeed a women might be able to take the drug without actually knowing whether she is pregnant.
Ongoing studies, including those at USC and the UC San Diego Medical Center, are designed to determine the optimum dose of the drug and the benefit of combining it with other medicines, such as prostaglandins.
