Drug Combination May Offer Abortion Option : Medicine: New use of substances previously approved by FDA was 96% effective in early pregnancies, study finds.
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.â€
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.â€
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.â€
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.â€
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.â€
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.
At a news conference Wednesday, Hausknecht urged that doctors do as he says, not as he has done: He wants them to wait until other clinical studies have been completed and the drug combination is approved for abortion by the FDA before they use the method.
The FDA’s Pendergast says, “We encourage women and their doctors†who want to administer the drugs for abortion to do so in a “scientific trial. This is still experimental.â€
In Hausknecht’s study, overseen by the Mt. Sinai School of Medicine and the FDA, he administered the two drugs to 178 healthy women who had been pregnant for no more than nine weeks. The women, from 18 to 47 years old, were first injected with methotrexate, whose side effects can include vomiting, diarrhea and cold sores.
After five to seven days, the women returned for a vaginal suppository of misoprostol, which usually causes cramps and bleeding. Hausknecht says 88% of the women aborted the “products of conception,†as he put it, within 24 hours. Eight percent of the women required a second dose of misoprostol several days later to complete the process. Seven women, or 4%, who did not abort even after a repeated dose underwent a surgical abortion using suction.
While ob/gyn researchers are generally encouraged, Creinin said Hausknecht’s study may be overstating the drugs’ effectiveness. That’s because two-thirds of the women were pregnant for no more than six weeks--and the shorter the pregnancy, the better the drugs work, he said. Also, Creinin said, the study neglected to account for the 15% of women who spontaneously miscarry in the first weeks of pregnancy. All in all, he said, the effectiveness of methotrexate and misoprostol may be as low as 90%.
Creinin also questions whether the two-drug regimen would be quite the boon to abortion rights that Hausknecht and other advocates have described. Most women seeking an abortion may be too far along in their pregnancy to use the drugs, he said, and will turn to surgical abortion, which is generally legal through the second trimester.
“I think it’ll be a very important part of the way abortions are done,†Creinin said. “It’s not an answer. It’s an option.â€
Whether most women would prefer the drug over the surgical method, which is considered 99% effective, is unclear.
Ballard of USC said, “Some women may just want to come in for an operation and get it over with.â€
