'Abortion pill': new data, new markets.

'Abortion pill': New data, new markets

In the largest study of its kind, the controversial French pill RU 468 appears safe and effective as a means of terminating pregnancies of less than seven weeks' duration, its developers say. Moreover, the so-called contragestive--approved in France in September 1988--may soon become available in some other European countries, says endocrinologist Etienne-Emile Baulieu of the University of Paris-South, who oversaw the drug's development.

Researchers and family-planning experts say the new data and the drug's move beyond French borders will excalate an already-heated debate about RU 486's potential role in the United States, where doctors perform 1.6 million abortions each year. Despite an estimated $1 billion U.S. market, no drug company has applied for FDA approval of RU 486, in part because anti-abortion activists have threatened to wreak financial ruin upon any group attempting to sell the drug here.

The new data -- which Baulieu says will appear soon in the NEW ENGLAND JOURNAL OF MEDICINE -- indicate the pill successfully induced abortion in 96 percent of more than 2,000 women studied, and in only one case triggered bleeding severe enough to require a blood transfusion. Previous studies showed about the same success rate but about twice the rate of serious bleeding. About 40,000 French women have taken the drug regimen, which costs the equivalent of about $45 and today accounts for about one-third of the abortions performed in France, Baulieu said in Boston this week at a symposium on "New Birth Control in the 1990s."

The pill blocks the action of progesterone, a sex hormone required for fetal survival. Women must return to their doctor 48 hours after taking the pill for a follow-up dose of prostaglandin, which triggers uterine muscle contractions. Expulsion of the fetus generally follows within a few hours. The new study indicates that pregnancy continued in 1 percent of the women. Most of the remaining failures resulted from incomplete expulsion requiring medical intervention.

"I think this compound is going to enter the USA very soon," Baulieu says. While some U.S. observers remain skeptical, others say growing demand for such a pill and the lack of any evidence of toxicity virtually ensure its eventual arrival in the United States. According to Baulieu, the drug's manufacturer will soon apply for permission to market RU 486 in England, Holland and Scandinavia and expects the drug to be available in those countries by the end of the year.