RU-486: Study Finds Drug Effective And Safe
A study in today's issue of the New England Journal of Medicine found the French "morning-after pill," known as RU-486 or mefipristone, "effective in terminating pregnancies" when taken with misoprostol, an FDA-approved prostaglandin drug. The researchers administered 600mg of the drug to 2,015 women, followed by 400 micrograms of misoprostol two days later. Among the subjects, "pregnancy was terminated in 762 of the 827 women pregnant for 49 days or less (92%), 563 of the 678 women pregnant for 50 to 56 days (83%), and 395 of the 510 women pregnant for 57 to 63 days (77%) (Spitz et al, 4/30 issue). The Boston Globe notes that the pregnancy termination "occurred within four hours of taking misoprostol in nearly half of the women studied and within 24 hours for 75%." Some women experienced such side effects as nausea, abdominal pain, diarrhea or vomiting. Despite these effects and being required to "make three visits to a health clinic over 15 days to receive the medications and to be sure the abortion was complete, [the subjects] were satisfied with the procedure," according to Dr. Beverly Winikoff, program director for reproductive health at New York-based Population Council, "a nonprofit health research organization that holds the U.S. patent" on mefipristone (Foreman, 4/30).
Long Time Coming
The New York Times reports that the study's results are similar to findings in France, where the drug was effective in 95% of cases (Kolata, 4/30). The reason for the slightly lower success rate was attributed to "surgical intervention by U.S. doctors who were not yet comfortable with the amount of bleeding caused by the medication," the Los Angeles Times reports. In addition, one of the study authors, Dr. Ann Robbins of the Population Council's Center for Biomedical Research, "noted that the success rate was 2% to 3% lower in women who had undergone a prior abortion." This may have impacted the outcome of the study because "51% of the women in the U.S. study had already had an abortion, compared to 25% to 27% in European studies" (Maugh, 4/30). The AP/Washington Post reports that the "FDA declared the drug safe and effective in 1996, after reviewing European data and hearing preliminary results from the U.S. study," but held off on full approval until "additional studies of its safety and effectiveness could be done in the" U.S. (Haney, 4/30).
Slow To Market
The Los Angeles Times reports that the study lays the "groundwork for the widespread use of the drug in this country," but the Population Council "has had difficulty finding a company willing to manufacture the drug in the face of boycott threats from antiabortion groups" (4/30). NPR's Noah Adams noted, "American researchers blame the political power of the anti-abortion movement for stalling the drug's entry into the U.S. market." Eleanor Smeal, president of the Feminist Majority, said, "Every roadblock that could be thrown in front of us has been. ... And what is so amazing to me is here is a drug that is very safe, very effective and would make it so that abortions are at the earliest stage, at the embryonic stage, not invasive, certainly better for women and we've had so much trouble" ("All Things Considered," (4/29). The Los Angeles Times reports that a spokesperson for the National Right To Life Committee "said the organization had not yet seen the study and had no comment on it" (4/30).
NPR's Patricia Neighmond reported that the Population Council has hired a pharmaceutical firm, the Danco Group, "to help them locate another manufacturer. Council officials say they're close to finding one, though they won't disclose any names. They say they hope to make RU-486 available to women in the U.S. by 1999." The National Right to Life Committee's Wanda Franz "says that when the name of that company is known, the committee will institute another boycott" ("All Things Considered," 4/30).