What a pill: RU-486

Don't believe the hype. The 'morning after' drug does
not offer women in need of abortions a safe, private alternative to visiting a clinic

by Margaret Doris

SOMEWHERE TONIGHT, SOMEBODY will forget to take a pill. A condom will break, a diaphragm will be left on the bathroom shelf. Last call will be followed by lost judgment. It will be many days before the consequences are clear.

But a month from now, women will be able to make a choice about ending a pregnancy that women cannot make today. Last week, the federal Food and Drug Administration (FDA) approved the sale in this country of the abortion pill, mifepristone -- or RU-486, as it has been known for many years. Danco Laboratories, the small, private company that holds the US distribution rights to mifepristone (or "Mifeprex," as they call it), says it plans to ship the first drug orders to abortion providers in four weeks. Across the country, many women and their health-care providers are eagerly looking to mifepristone as a way to de-surgicalize the abortion procedure.

And why not? After all, an abortion pill is something a woman can take in her own home, isn't it? She would not have to cross protest lines at an abortion clinic, or cede control of her body to medical practitioners.

"Some women will prefer having an option that's noninvasive, that they perceive as more `natural,' " says Pam Nourse, public-affairs director for Planned Parenthood of Massachusetts. But, she acknowledges, "noninvasive" does not mean an at-home, do-it-yourself procedure.

Indeed, if the drug is administered according to the manufacturer's recommendations and FDA guidelines, mifepristone abortions require a minimum of three medical visits, at least one more drug, and additional medical procedures such as a vaginal ultrasound. When a woman is judged to be an acceptable candidate for the procedure, she is given the mifepristone in the form of three pills, which she may be required to swallow in the presence of a doctor or nurse. Thirty-six to 48 hours later, the woman returns to the clinic to receive prostaglandin, which in this country will be in the form of misoprostol, a drug originally approved by the FDA to treat ulcers. This blocks production of progesterone, a hormone that is necessary to maintain pregnancy. It will cause the uterus to contract, expelling the fetal tissue.

A little less than two weeks later, the woman must return again, so a physician can determine whether the abortion is complete. If not, it must be finished surgically. Mifepristone can be used only very early in pregnancy -- no more than nine weeks, and preferably seven weeks or fewer, into gestation (it is usually administered within 49 days from the beginning of a woman's last menstrual period). Bleeding or spotting can be expected to last an average of nine to 16 days, but may persist for 30 days or longer. One percent of women will have bleeding so heavy they need a surgical procedure called curettage to stop it. Approximately five to 10 percent of women who use mifepristone will fail to abort, and will need to have their pregnancies surgically terminated. And because the majority of mifepristone abortions will be arranged through abortion clinics (at least at first), women will not be protected from protest-line harassment.

Any number of pre-existing physical conditions -- such as adrenal insufficiency, the presence of an IUD, or a recent history of steroid use -- may make a woman ineligible for the procedure. In addition, caution is urged in using mifepristone in women older than 35, or in those who smoke. A vaginal ultrasound may be done to confirm fetal age and to rule out ectopic pregnancy.

It's unclear how many providers will be willing, or able, to offer the drug. "A woman will be able to go to her own health-care provider," says Heather O'Neill, director of public affairs for Danco. "All ob/gyns [and] many family practitioners could provide this service." But O'Neill's optimism may be premature. State laws governing abortion providers vary widely and may result in compliance problems, especially for doctors who don't already offer surgical abortions.

"I think it will be a problem as new providers want to add it to their practices," says Vicki Saporta, executive director of the National Abortion Federation (NAF). "Especially when you're talking about fetal remains." The recovery and disposal of such remains are governed by many states' abortion laws. Since women taking mifepristone usually expel the fetal tissue at home, will they be required to bring the tissue back to the provider? What will happen if the provider, in attempt to obey the law, requests the tissue but a patient does not comply? Other state laws regarding physical-plant structure, accommodations, and emergency equipment may also limit a physician's ability to offer the abortion pill. The NAF has received a grant from Danco to train health professionals who are interested in prescribing the pill. However, anecdotal evidence suggests that a significant percentage of providers who express interest in prescribing the drug decide not to do so once they learn it is a multi-step procedure, and that they may have to make special efforts to fulfill state abortion regulations.

"We do hope that eventually mifepristone will offer women more power," says Stephanie Mueller, spokesperson for the NAF, which represents clinics and other abortion providers. "Obviously women will still be accessing clinics and will still be facing harassment. Certainly the promise of mifepristone is the promise of eventual privacy, but we believe it will be gradual."

ORIGINALLY, NONSURGICAL abortion looked relatively simple. Almost 20 years ago, when researchers and consultants with the French pharmaceutical firm Roussel-Uclaf succeeded in synthesizing the steroid RU-486, initial tests revealed that the drug might have potential as a contraceptive, a "morning after" pill, or an early-abortion pill.

After only 17 months of animal research, RU-486 was judged promising and safe enough for use in clinical trials with women. Eleven pregnant women were given the drug. Nine pregnancies were terminated; one woman needed a uterine evacuation, and another experienced heavy bleeding, necessitating a blood transfusion and emergency surgery. Clinical trials were then expanded to include women in eight countries.

Researchers soon discovered that RU-486 alone was not enough to cause complete abortion in approximately 40 percent of women. They then began experimenting with RU-486/prostaglandin combinations. To control the resulting pain, women were given narcotics and, in some cases, birth-control pills. The "simple abortion pill" had resulted in a complex procedure requiring close medical supervision.

In 1992, French officials acknowledged under pressure that, among an estimated 60,000 patients, there had been at least one death attributable to complications from an RU-486 abortion. They confirmed that in March 1991, 31-year-old Nadine Walkoviak went into cardiovascular shock after being given a prostaglandin injection as part of the RU-486 abortion procedure. Although her reaction was extreme -- and French investigators attributed it, at least in part, to the fact that she was a heavy smoker -- "acceptable complications" of RU-486 abortions documented by the drug's manufacturer include severe pain requiring treatment with narcotics, significant nausea and diarrhea, prolonged bleeding that in some cases requires transfusion, and incomplete abortions.

Since RU-486 first received marketing approval in France in 1988, more than 500,000 women in Europe and an unknown number -- possibly millions -- in Asia have terminated their pregnancies with some combination of mifepristone and other drugs. Mifepristone abortions in this country have been limited to women participating in authorized clinical trials, but physicians have been doing a small number of medical abortions using methotrexate, a cancer drug (once a drug has been approved by the FDA, physicians are free to prescribe it for non-authorized uses). "I believe we've been offering methotrexate for about six years, for a very small number of women," says Planned Parenthood's Nourse. "It doesn't work as fast -- it can take up to 29 days."

AS ABORTIFACIENT procedures go, RU-486 is not at all easy to use," Roussel-Uclaf chairman Edouard Sakiz acknowledged to Le Monde in 1992. "In fact it is much more complex than the technique of vacuum extraction. True, no anesthetic is required. But a woman who wants to end her pregnancy has to `live' with her abortion for at least a week using this technique. It's an appalling psychological ordeal."

Others dispute Sakiz's characterization. In a 1998 study published in the Journal of the American Medical Association, researchers reported that the majority of women for whom mifepristone had failed said they would still try the method again, and would recommend it to their friends. However, the study was sponsored by the Population Council, a New York-based nonprofit organization that conducts international research on reproductive health, and that has lobbied long and hard for FDA approval of RU-486.

In 1994, Roussel-Uclaf -- recognizing that the American anti-abortion movement would mount serious, and expensive, obstacles to FDA approval -- donated the rights to sell mifepristone in the US to the Population Council. After trying and failing to get large drug companies to sell the drug, the Population Council solicited proposals from groups interested in licensing and distributing it. The organization initially settled on a group headed by lawyer Joseph Pike, but withdrew from the agreement following a discovery that he had been disbarred after pleading guilty to forgery. In 1997 the rights were transferred to Danco, a group made up of many of the investors involved in the Pike effort.

In countries where mifepristone abortion is legal, the percentage of women who choose the procedure varies widely. Social and cultural issues, as well as provider preference, probably influence its popularity. Danco's O'Neill says it is "impossible to predict" how it is going to do in the US.

"We're making plans to offer it in all of our Planned Parenthood clinics, no later than the first of the year," says Nourse. "I think it's really unclear at this point how many of our procedures will be medical [mifepristone] abortions."

What is clear is that despite all the hype, mifepristone does not offer women a safer, easier way to terminate a pregnancy. And despite the hopes of the women's and abortion-rights organizations that have spent more than a decade pushing for its approval, it offers women and their physicians virtually nothing in the way of increased privacy or protection from anti-abortion forces.

Arguably, privacy and protection have been the driving forces in the struggle to have mifepristone approved. If abortion were to become a simple, private act, it might be removed from the public arena and, perhaps, from government control. But mifepristone does not offer that. The consequences for women who believed it would are still, for now, unknown.