MIFEPRISTONE; WHAT’S HAPPENED TO RU-486 DURING ITS FIRST YEAR IN THE U.S.?

Results

According to the Kaiser Family Foundation 2001 national survey, which was given to 595 gynecologists and 195 general practice physicians over the phone, 6 percent of gynecologists and 1 percent of general practitioners offered drug-induced (also referred to as medical) abortions. Another 16 percent of gynecologists and 7 percent of general practitioners say they are “likely” to begin offering the drug in the next year.

About 27 percent of gynecologists said they perform surgical abortions, with 10 percent doing so “routinely.” Of general practice doctors, only 1 percent do surgical abortions.

The study also revealed that less than half the doctors who refrain from medical abortions do so because they “personally oppose” the practice. Other reasons cited included lack of patient demand, concerns of protest or violence, a lack of interest in performing abortions, inadequate office space set-up and the political controversy surrounding abortion.

The study also interviewed more than 1,000 adults who were not doctors about mifepristone. Of that number, about 61 percent of women of childbearing years (ages 18 to 44) had heard of it, but only 14 percent properly identified it as a nonsurgical abortion option. Almost half – 42 percent – confused it with emergency contraceptive pills used to prevent pregnancy following unprotected sex or contraceptive failure such as condom breakage.

When the Food and Drug Administration finally approved mifepristone -otherwise known as RU-486 – upheaval was predicted in the abortion arena.

Those in favor saw the passage as a safe, private procedure for unwanted pregnancies and a vindication of women’s rights. Those against saw this as an all-too-easy recourse to abortion and a further erosion of the rights of the unborn.

In general, the abortion rate has been declining. From 1992-97 (the last years for which figures are available), the rates decreased from 1.5 million to 1.2 million. But abortion still remains a common health concern for women – one in four pregnancies ends in abortion or, in other numbers, about 43 percent of American women will have an abortion by age 45. Of these women, nearly half are age 25 and older.

One year after the FDA’s approval, a Kaiser Family Foundation study has found that mifepristone’s availability has had little impact either way and that only a tiny number of private physicians have begun administering the nonsurgical option.

“The reality is, for all medical innovations, it takes a time for the clinical community to adapt anything,” says Dr. Felicia Stewart, the co-director of the Center for Reproductive Health Research and Policy at UC San Francisco. “Overnight we had Viagra, but that will not be the case for the typical medication.”

The response is in line with what was expected, says Vicki Saporta, executive director of the National Abortion Federation.

“It’s actually very similar to what we have been saying all along. Initially mifepristone would be available through current abortion providers, then others would gradually offer these services to women.”

Shipped last November

Danco Laboratories had begun shipping the pills – under the brand name Mifeprex – to physicians on Nov. 20, 2000. As with intrauterine devices, Mifeprex requires that the doctor, not a pharmacist, dispense the pills. According to the Danco Laboratories’ Web site (www.earlyoptionpill.com)[VHC4], the procedure entails three visits. On the first visit, the woman receives three tablets; on the second, two days later, she takes two tablets of misoprostol (to expel the embryo and uterine lining), and a final follow-up appointment occurs about 12 days later.

Mifepristone has been more available in the Bay Area than other parts of the country. One of its primary dispensers has been Planned Parenthood. In the first three months this year, affiliates nationwide performed about 2,000 mifepristone abortions.

The Shasta-Diablo branch of Planned Parenthood – which covers Alameda, Contra Costa, Butte and Solano counties – began offering it as an option not long after FDA approval, in part because the branch has been one of the sites for a clinical study of methotrexate, another new medical abortion drug.

Methotrexate – a medication used in chemotherapy, rheumatism arthritis and psoriasis – stops the development of the placenta, explains Leslie [MBC5]Barron-Johnson, vice president of center services at Planned Parenthood Shasta-Diablo. Mifeprex, on the other hand, blocks the hormone progesterone, thereby causing the embryo to detach from the uterine lining.

Of the 3,000 abortions done per year in Contra Costa County by Planned Parenthood Shasta-Diablo, about 175 are medical abortions, both mifepristone and methotrexate. “We also provide approximately 70,000 services other than abortion a year in Contra Costa County,” Barron-Johnson adds.

Mifepristone has attracted inquiries from women and doctors alike. The National Abortion Federation had to increase its hotline hours by another four every weekday and added weekend hours. Nationwide, one out of three callers inquired about medical abortion in the first six months; nearly half of California callers had questions about mifepristone. But whether on a national or local level, the increased number of calls inquiring about the procedure has not translated to an increase in the overall number of abortions.

While interest exists, several factors prevent mifepristone’s widespread acceptance. Among them is the $400 to $450 price tag for the five-pill dosage and doctor or clinic visits. Medicaid funding in most states covers abortion only in cases of rape, incest or medical necessity, and about 31 percent of women with employer-based insurance have abortion coverage.

Another drawback lies in the pill’s narrow window of efficacy. Although the latest figures show mifepristone to be effective up to 63 days or the ninth week of pregnancy, the standard prescription advises use within the first seven weeks. By the time a woman realizes she is pregnant – and if she has not waited two menstrual cycles to notice or make sure – she has less than a month to make her decision.

“No matter what, it’s important to give yourself the time and thoughtfulness to make a wise decision about pregnancy. It’s an important decision; it’s not a trivial decision,” Stewart says. “That being said, the risks and complications that can occur with abortion are very strongly related with the time of pregnancy when it’s done.”

However, she says, by the time they find out, most women already know what they want to do.

Another consideration is time. Medical abortions generally take two days, which can involve cramps and bleeding, and three office visits over the course of about two weeks. A surgical procedure takes place the same day and, with anesthesia, little pain.

Limited access

Although administering a pill attracts less public attention – about half of the gynecologists surveyed had cited concerns about protest, violence and political controversy – abortion providers are still small in number, and abortion services in general are not available for women in 86 percent of all U.S. counties.

“Access to abortion is now a very severely constrained health service for women, and that certainly includes medical abortion,” Stewart explains.

Bay Area clinics and hospitals – even those already providing surgical abortions – are adopting a wait-and-see attitude.

“Our physicians are very interested,” says Frank Puglisi, executive director of the Contra Costa Regional Medical Center in Martinez. Currently, the center, with clinics throughout the county, has about seven or eight physicians who do therapeutic abortions. “There are some protocols that have to be put in place – For example, the physician who prescribes the medication also has to have privileges to do an emergency procedure if necessary.”

Stewart points out that since 15 percent of pregnancies end up in spontaneous miscarriage, such medical backup is standard. Mifepristone’s failure rate is 5 percent, as opposed to surgical abortion’s 1 percent.

“To me, the real issue is the regulatory attitude,” says Walnut Creek physician Dr. Judith Hartman. “Even though abortions are perfectly legal, they’re forcing it underground, and I think that’s unfortunate. – The number of providers has really decreased because of fear, and that worries me more than whether it’s medical or surgical.”

Vera H-C Chan is the Times event editor. She can be reached at 925-977-8428 or at vchan@cctimes.com.

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