RU Pissed Off Yet?

After 10 Long Years, American Women May Finally Get the Abortion Pill—With Restrictions that Could Obliterate All It Has to Offer

The protests might have been brushed off as mere annoyance. Instead, the hospital where the abortion was performed forbade the doctor involved from doing any more medical abortions, citing an increase in its malpractice insurance rates. Insurance prices likely did play a part in the hospital's decision. With standard rates for medical abortion not yet set, some doctors report being quoted prices that are higher for medical abortion than for delivering babies, which is far riskier.

Abortion opponents see such bureaucratic deterrents as the next frontier in the war against RU-486. "I don't think your average doctor is really going to want to be getting into this when he realizes the kinds of logistical problems involved," says Laura Echevarria, spokesperson for the National Right to Life Committee. "Do doctors really want to set themselves up for the possibility of lawsuits?"

Whether they want to or not, pro-choice attorneys are steeling themselves for the legal battles many think would inevitably follow approval. "They'll pull out their bag of tricks, try to obfuscate and intimidate and obstruct access to it," Donna Lieberman predicts of her pro-life opponents. Lieberman, who directs the New York Civil Liberty Union's Reproductive Rights Project, also expects that medical abortion will prove easier to defend against legal challenges than traditional surgical abortion, which is already regulated as to how and where it's performed. "What are they going to say—that you have to have a 600-square-foot operating room to give out a pill?" asks Lieberman. "That's just ridiculous. I think any judge would agree."

Until they do get to the courts, both sides are focusing on the upcoming election, which may determine whether the drug is even available to fight over. "A chief executive opposed to RU-486 would significantly decrease the chances that mifepristone would be approved," says Simon Heller, director of the Center for Reproductive Law and Policy's domestic program. If RU-486 isn't approved by election time, Heller says the president could influence the FDA through his choice of secretary of health and human services. If the drug were already approved, the president "might get the FDA to issue special, discriminatory restrictions on its distribution, saying that it can only be given out in hospitals, for example." Beyond that, Heller declined to comment, not wanting "to give them any ideas."

But ideas about how to stop RU-486 already abound. Both last year and this one, Oklahoma representative Tom Coburn, a Republican, sponsored amendments to the agricultural appropriations bill that would have banned the FDA from developing and approving mifepristone or any other abortifacients. The most recent amendment was voted down in July by a five-vote margin. Though he hasn't said how, George W. has also made it clear he'd do his best to stop RU-486. "It's abortion," Bush has explained.

Well, exactly. Opposition to abortion is what has kept RU-486 out of reach. And those who support women's right to choose may want to put up a big, French-style fuss until they get access to this simple medical innovation. Petitions and angry letters worked when RU-486 seemed doomed in France. If such an outcry doesn't get mifepristone approved here by September 30, pro-choice Americans can take the fight to the voting booth.

The Star Pill
An Abortion Drug Goes Underground While we're waiting around for RU-486 and its promise of safe and legal medical abortion, some American women have been using another pill without supervision or a prescription to end pregnancies. In its unregulated state, at least, this underground medication turns out to be not that safe—and not that legal. Cytotec is the brand name of misoprostol, a drug approved as an ulcer treatment in the U.S. and more than 72 other countries. It's also the pill taken (both orally and vaginally) along with RU-486 in U.S. clinical trials to induce abortion. If and when the FDA approves an RU-486 regimen, Cytotec is expected to be included as part of it to help make the uterus contract. Indeed, it turns out that Cytotec can often make the uterus contract—and cause an abortion—even without RU-486, a discovery that has made it one of the hottest drugs on the black market. Almost a third of more than 600 women recently interviewed in a Washington Heights clinic said they were familiar with Cytotec, which is known on the street as the star pill (because the tablet has five sides). Five percent of women in the study, which was published in the Journal of the American Medical Women's Association, said they had used Cytotec. Buying the star pill is perfectly legal—if you have a prescription for it. Without one, some women have been paying their pharmacists between $5 and $7 for a pill that costs about 35 cents when sold with a prescription. (RU-486 isn't approved for any purpose in the United States, so it doesn't show up on drugstore shelves.) In New York City, much of the Cytotec use seems to take place among immigrants from Latin America, where women have been inducing abortion with it for much of the past decade. Risking an unsupervised abortion with a black-market pill makes some sense in countries where abortion is illegal and women don't have better options. In fact, Cytotec is widely credited with bringing down Brazil's rate of complications from illegal abortions induced with herbal teas and inexpert attempts to get through the cervix. But taking Cytotec without knowing how to proceed or what to expect causes its own complications. Some women have taken too much of the drug, according to Brazilian reports; others took it too late in pregnancy, causing serious bleeding, incomplete abortions, and sometimes premature delivery. The star pill has caused its share of problems in the U.S. as well. Mark Rosing, the OB-GYN who conducted the JAMWA study, says he decided to investigate Cytotec after treating almost 50 women with post-Cytotec problems in only three months as an emergency-room resident. "I saw a number of patients coming in hemorrhaging, or with incomplete abortions, with portions of the pregnancy inside," says Rosing. "A lot of my colleagues saw and heard the same thing." Given the problems it's caused, Cytotec seems more of a hazard than a help in a country where other methods are legal. But, whether for financial reasons or because they were afraid to go to their doctor or just wanted to avoid the minor surgery involved in other types of abortions, some women seem to be taking the risk. For those without other options, Rosing hesitantly acknowledges a role for the less-than-perfect star pill. Says Rosing, "I'd rather see a 16-year-old who doesn't have access to a safe abortion use this than try something more drastic like a coat hanger or some sort of weird tea." —S.L.
Time Marches On
A Chronology of RU-486 1980: Roussel Uclaf, a French company, synthesizes mifepristone, which it dubs RU-486.
1981: First RU-486clinical trial is undertaken in Geneva.
1983: The U.S. Food and Drug Administration gives the Population Council, a nonprofit organization, a permit to test RU-486 as an early-abortion method in the U.S.
1987: A complete set of safety and efficacy information on RU-486 is compiled.
1988: A French application for RU-486 is approved.
1989: The FDA (under George Bush Sr.) puts RU-486 on the import ban list; individuals are allowed to bring other drugs into the country for their own use, but not RU-486.
1990: RU-486 becomes commercially available in France.
1991: The United Kingdom approves mifepristone.
1992: Sweden approves mifepristone. July—Federal agents seize a single dose of mifepristone from Leona Benton, a pregnant 29-year-old who tries to bring it into the United States from London. Benton isunsuccessful in her attempt to get the courts to order the pill returned to her and eventually has a surgical abortion.
1993: Upon entering office, President Clinton lifts the import ban and orders the Department of Health and Human Services to "promote the testing, licensing and manufacturing" of RU-486.
1994: The National Right to Life Committee launches a consumer boycott of Roussel Uclaf's American subsidiaries. Roussel Uclaf, having decided it does not want to get tangled up in American abortion politics, donates the licensing rights for RU-486 to the Population Council.
1994-1995: The Population Council conducts clinical trials involving more than 2000 women in the U.S.
1996: March—The Population Council submits a new drug application to the FDA for RU-486. The agency issues an "approvable letter," declaring the drug safe and effective but requesting additional information about labeling and manufacturing.
November—Joseph Pike, a businessman hired by the Population Council to head the effort to arrange for manufacture and marketing of mifepristone, admits he has been convicted of fraud and forgery.
1997: Gedeon Richter, the Hungarian manufacturer that had agreed to produce mifepristone in the U.S., backs out.
1999: Mifepristone is approved in Switzerland, Austria, Belgium, Denmark, Spain, Finland, Greece, Germany, the Netherlands, and Israel. The Population Council and Danco, a group of investors formed to market mifepristone, submit the requested information to the FDA. Approval is widely expected by early 2000.
2000: February—The FDA issues another approvable letter for the use of mifepristone in early abortions, but says more information is still needed. June—The Washington Post reports that the FDA is considering approving mifepristone with stringent restrictions. The agency sets another approval deadline for September 30. July—Representative Tom Coburn's amendment to an agriculture appropriations bill, which would forbid the approval of mifepristone, is voted down. September 30—By this date, if it holds to its schedule, the FDA will have approved, rejected, or requested still more information about mifepristone. —S.L.

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