Abortion Pill May Join List Of New Drug-Based Options
April 03, 2011
RU-486, the abortion pill recommended for approval by a regulatory panel, isn't the only new abortion option for American women. Two other pharmaceutical methods for ending or preventing pregnancy may soon come into wider use -- in large part because they involve drugs already on the market for other purposes. The abortion pill cleared a major hurdle on Friday when an advisory panel recommended that the Food and Drug Administration approve the product. The FDA could approve RU-486, also known as mifepristone, for use in the U.S. by early fall. Three weeks ago, the same FDA advisory panel ruled that certain combinations of existing birth-control pills could safely and effectively be used as ``morning-after pills'' to prevent pregnancy when taken within 72 hours after sexual intercourse. Some antiabortion groups argue this process can amount to abortion. Meanwhile, the combination of methotrexate, a cancer and arthritis drug, and misoprostol, an ulcer drug, also has been found to induce abortion. Ricki Mortimer, an obstetrician at the Mount Sinai School of Medicine in New York, revealed in the New England Journal of Medicine last summer that the combination caused abortions in 171 of 178 patients, with side effects similar to RU-486. Since then, Dr. Mortimer says he has been besieged by calls from American doctors interested in the method, although most physicians aren't using the drug combination until larger clinical trials are completed. Delivery of these new alternatives will depend largely on doctors because drug companies are reluctant to market abortion-inducing drugs amid fears of product liability and political controversy. Methotrexate, for example, is available from various drug companies, including American Home Products Corp.'s Wyeth-Ayerst Laboratories unit, which also markets birth-control pills. But American Home isn't going to market the drug for abortions. An American Home spokeswoman says, ``We do not market, promote or research methods for use in early termination of pregnancy,'' and the company doesn't plan to do so. As for using birth-control pills as a morning-after remedy, she adds: ``We do not now and have no plans to market any birth-control pill formula for postcoital use in the U.S. The risk of litigation is our primary concern.'' Nevertheless, doctors are free to begin using the cancer drug and regular birth-control pills for abortions. That is because the FDA regulates only what drugs are allowed on the market and what companies can say about them; doctors are legally allowed to use approved drugs for unapproved purposes. Dr. Mortimer of Mount Sinai says a group of doctors eventually plan to submit an application for FDA approval of the use of methotrexate for abortion purposes. Usually, the FDA advisory panel takes requests for new uses from drug companies. The Population Council, a nonprofit research group in New York, received American patent rights for RU-486 from Roussel Uclaf SA, the French unit of Hoechst AG of Germany that developed RU-486 and markets it in Europe. The group has spent $12 million on clinical trials for the new drug application. It has tapped a new nonprofit organization in Washington, Advances in Health Technology Inc., to coordinate distribution and manufacturing. The group will sell the drug directly to doctors and health organizations and also train them to use it. Neither group will name the third-party manufacturer that will produce the drug, out of fear that it could face a boycott or violent protests. But both say the company has the capacity to produce an ``ample'' supply. The panel on Friday recommended that patients receive misoprostol in addition to RU-486; studies show that the two-step process is more effective than taking RU-486 alone. The new choices could put doctors back in the abortion business after a steady decline. Amid rancorous and sometimes violent protests of antiabortion groups, the number of doctors willing to perform the procedure had dropped to fewer than 2,400 by 1992, down almost 20% from a decade before, according to the Alan Guttmacher Institute, a nonprofit group that favors abortion rights. Federal officials say that 1.3 million abortions were performed in 1993, down from a high of 1.4 million in 1990; abortions are believed to have continued declining since then. But a recent survey by the Kaiser Family Foundation found that one-third of obstetricians who don't perform abortions would prescribe mifepristone if it became available. ``There is potential for considerable expansion,'' in the number of abortion providers, says Jami Tello, who heads the Office of Population Research at Princeton University. ``American women are slowly getting more options,'' says Glynda Raya, president of Planned Parenthood in New York. ``It's about time.'' Antiabortion groups counter, however, that all three methods could increase the frequency of an emotionally and physically painful procedure when other measures, such as prevention and adoption, should be pursued. And some critics charge that RU-486 can cause life-threatening bleeding. Doctors who conducted clinical trials of RU-486 admit that excessive bleeding is a rare complication of the abortion pill, but say that happens in less than 1 in 500 cases. They also note that hundreds of thousands of woman have taken it in France, England and Sweden for years with few major problems. --Sung Geddes contributed to this article.
