Approved drugs mixed to mimic the abortion pill

October 11, 1994|By New York Times News Service

The so-called abortion pill from France, RU-486, is still illegal in this country, but a New York gynecologist has used two drugs already on the market -- but approved for other purposes -- to perform more than 100 abortions without surgery.

Richard Hausknecht, a longtime abortion-rights crusader, has been criticized by medical researchers for using the method in his private practice before its safety and efficacy are determined in clinical trials, which are under way in three U.S. cities. And drug-induced abortions draw immediate fire from anti-abortion activists, who argue they are experimental and exploitative.

But Dr. Hausknect insists -- and authorities seem inclined to agree -- that he is doing nothing illegal by offering the $500 drug treatments. He argues that the method should be available immediately to give women an alternative to surgical abortions and acknowledges a political motive.

"My goal is to show the medical community that there is a safe, simple, effective, legal technique of terminating pregnancies that private and inexpensive," said Dr. Hausknecht, who helped found the National Abortion and Reproductive Rights Action League and establish the first independent abortion clinic in New York City.

"There are parts of this country where abortion simply isn't available, where patients have to travel hundreds of miles and face picket lines at clinics. This technique can be performed in a local doctor's office or even by a nurse practitioner."

Like RU-486, this technique works by inducing a miscarriage in two stages. First, the woman, who must be no more than eight weeks pregnant for the drug to be effective, receives an injection of methotrexate, a drug that inhibits tissue growth and has been used for decades to treat cancer tumors, arthritis, psoriasis and ectopic pregancies.

Four days later, tablets of misoprostol -- a drug approved for preventing stomach ulcers that has also been used in pregnant women to hasten labor -- are inserted in the vagina. The woman goes home and usually expels the embryo within three days.

Dr. Hausknecht said he has performed 126 abortions in this way. Of those, he said, 121 were successful using the drugs; in five cases surgery was needed to complete the procedure.

His work was unsupervised and was not a formal scientific study, he acknowledged, but he said his results were roughly comparable to those found with RU-486, which is widely used in Europe but still not approved in the United States. He said he was willing to make his results public.

'Off label' purposes

Introduction of RU-486 was delayed for years by threats from the anti-abortion movement to boycott its manufacturer, Roussel Uclaf.

As a result of intervention from the Clinton administration, testing of RU-486 is scheduled to begin this fall, but it is not expected to be approved for general use before 1996.

The generic drugs used by Dr. Hausknecht are available by prescription in pharmacies and cost less than $10 per abortion.

Although neither has been approved by the Food and Drug Administration for abortions, once a drug is on the market physicians are generally allowed to use it for "off label" purposes as well.

"It's perfectly legal and appropriate for a physician to prescribe an approved drug for any use that he or she feels is appropriate," said Lawrence Bachorick, a spokesman for the FDA.

"But we think it's important that patients make an informed choice about the product. In Dr. Hausknecht's case, we think the women should know it's an experimental procedure, and we would prefer that the treatment be monitored by outside observers."

Researchers who are studying these drugs for use in abortions have also expressed concern about Dr. Hausknecht's treatment. The most critical has been Dr. Mitchell Creinin, an assistant professor at the University of Pittsburgh School of Medicine, who has been conducting clinical trials of the drugs.

"What he's doing is unethical . . .," Dr. Creinin said. "It's true that the drugs are very safe in the low doses being used, but just because something is safe doesn't mean you can use it for your own experiments. He shouldn't be doing an experiment without the approval of the FDA and the oversight of an institutional review board, and he shouldn't be charging people for it."

Anti-abortion activists also have attacked Dr. Hausknecht's methods.

He's "using women like guinea pigs," says Carey Garst, a spokeswoman and lobbyist for Maryland Right to Life. "That seems to me to be highly dangerous and exploitative -- not to mention that a child dies as a result."

Ongoing clinical trials

Clinical trials of hundreds of women are still going on -- final results are expected in a year -- but the researchers say their preliminary findings have been encouraging.

"Methotrexate seems to be very effective for abortion," said Dr. Eric Schaff, an associate professor at the University of Rochester School of Medicine. "The side effects are minimal, and the women's satisfaction seems to be very high."

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