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Drug Combination May Offer Abortion Option : Medicine: New use of substances previously approved by FDA was 96% effective in early pregnancies, study finds.

August 31, 1995|TERENCE MONMANEY | TIMES MEDICAL WRITER

American women seeking an abortion but wary of surgical procedures or violence-prone clinics may soon have another option, according to a new study showing that a two-drug combination was 96% effective in inducing abortion in the first nine weeks of pregnancy.

The study, conducted by a New York City gynecologist and self-described abortion crusader, promises to affect not only the way doctors terminate pregnancies but also America's ceaseless, soul-wrenching, sometimes murderous debate over the right to legal abortion.

Unlike the so-called French abortion pill, RU-486, which is limited in the United States to just a few medical researchers, these two drugs are widely available here, having previously won Food and Drug Administration approval for other uses.

They are methotrexate, an anti-cancer drug that is toxic to fast-multiplying tissue, including fetal tissue, and misoprostol, an anti-ulcer drug that causes uterine contractions, which can expel an embryo.

Although the FDA has not approved the drugs for abortion, the agency doesn't stop private physicians from prescribing drugs for reasonable "off-label" purposes, said FDA Deputy Commissioner Mary Pendergast.

Dr. Mitchell D. Creinin, a pioneering abortion drug researcher at the University of Pittsburgh School of Medicine, said the new research "makes an important contribution to the medical literature and the medical community."

The study appears in today's New England Journal of Medicine and was conducted by Dr. Richard U. Hausknecht. Saying that "social and political factors have blocked medical approaches to pregnancy termination in the United States," Hausknecht concluded that this two-drug approach "makes it possible to integrate a woman's personal choice about her pregnancy into the everyday practice of medicine."

Kate Michelman, president of the National Abortion and Reproductive Rights Action League, called the findings "very, very promising." An advantage of this method over the standard surgical technique, she said, is that all sorts of doctors could administer the drugs, thwarting abortion protesters who target designated clinics.

"This would enable women who need an abortion to have that medical service accomplished through visits to their family doctor or internist as well as their ob/gyn," she said.

Anti-abortion forces are deeply critical of the drug approach. The National Right to Life Committee "strongly opposes" the drugs "because they kill unborn children and because the long-term side effects for women are unknown," NRLC President Wanda Franz said in a news release. She added, "It is a tragedy that pro-abortion advocates want to use women as guinea pigs."

Methotrexate, in addition to being used against cancer, psoriasis and rheumatoid arthritis, was first used as an abortifacient a decade ago to end ectopic pregnancy, a life-threatening condition in which an embryo lodges in the Fallopian tubes. Since then, said USC ob/gyn researcher Dr. Charles A. Ballard, "methotrexate has almost become the standard of care in ectopic pregnancies."

Doctors are concerned about the potential for adverse effects of methotrexate, but the doses used to end pregnancy are only a fraction of those for treating cancer, they say. And researchers have not documented lasting harmful effects in the many women with ectopic pregnancy who have been given the drug.

Misoprostol also has been used alone to induce abortion. A misoprostol black market thrives in Brazil, where abortion is illegal. Recently, U.S. studies have revealed that it's about 50% effective when used alone.

It was in January, 1993, that researchers led by Creinin, then at UC San Francisco, first used methotrexate and misoprostol together to end a normal pregnancy. Last fall, in the Journal of the American Medical Assn. Creinin and a co-author published a study that showed that the two drugs effectively induced abortion in 90% of the 31 women tested.

A 30-year-old woman who underwent a methotrexate-and-misoprostol abortion at San Francisco General Hospital, where that smaller study was done, said she preferred the drugs to the surgical abortion she had undergone previously. "It was so much easier on me and my family," the woman said. "Emotionally I didn't feel like I was being ripped apart. [And physically] I didn't feel violated."

Last fall, Hausknecht captured wide publicity when news reports said he had performed more than a hundred abortions using the drugs. Praised by some doctors for offering women a choice, he was criticized by others for conducting a study lacking institutional oversight, which ensures that patients are adequately informed of, and protected from, the risks of undergoing experimental treatments.

Indeed, the first paper that Hausknecht submitted to the New England Journal was rejected because he had no such oversight, said Editor-in-Chief Dr. Jerome Kassirer.

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