To: Lizzie Tudor who wrote (45673 ) 10/13/2000 2:41:34 PM From: Shoot1st Read Replies (2) | Respond to of 769670 Concerned Drugmaker Could Effectively Block Abortion Pill Friday, October 13, 2000 By Adam Pasick NEW YORK — The rollout of the recently approved "abortion pill" may be held up by unexpected source: the manufacturer of a drug used in the controversial treatment. The Searle pharmaceutical company, which makes misoprostol, an anti-ulcer medicine that is essential for drug-induced abortions, has warned doctors not to use the product in tandem with the abortion drug commonly known as RU-486. Doctors who honor Searle's request could not prescribe RU-486, which will be sold under the name Mifeprex, because it cannot be used on its own. Mifeprex actually detaches the fetus from the uterus, but women must also take misoprostol to expel the dead fetus. On Aug. 23, more than a month before RU-486 was approved by the Food and Drug Administration, Searle sent out a strongly worded letter, with the cooperation of the FDA, saying misoprostol "is not approved for the induction of labor or abortion." The letter said misuse of the drug can cause adverse effects such as a ruptured uterus, vaginal bleeding and "maternal or fetal death." Misoprostol has been used for at least seven years as a cheap and effective way to induce labor, independent of its role in drug-induced abortions. But despite Searle's objections, the FDA approved use of the drug in conjunction with RU-486, touching off a debate among supporters and opponents of the abortion pill treatment program. Searle's action "will cripple the use of RU-486" if it is honored by doctors, charged Dr. Charles Lockwood, chair of the obstetrics committee at the American College of Obstetricians and Gynecologists (ACOG). "We're very concerned by the timing of the letter, coming within weeks of the approval of RU-486 by the FDA." Searle declined to comment on the non-ulcer uses of misoprostol. And despite the company's concerns, doctors may continue prescribing the medicine as they like. "To be fair to Searle, they're being placed right in the middle of a maelstrom," Lockwood said. "They created a wonderful ulcer drug, and that was all they wanted. But it turns out to be a great drug for obstetrics" — and for abortion. RU-486 opponents argue the Searle letter proves their argument the drug-induced abortion method is simply too dangerous. Sen. Tim Hutchinson, R-Ark., and Rep. Tom Coburn, R-Okla., have introduced a bill that would create additional restrictions on the process. "The debate has more to do with how the FDA steamrolled the process," said Coburn's press secretary, John Hart. "The FDA wrote the letter to give Searle legal protection in future lawsuits from women who will be harmed by the two-drug combination." ACOG sent Hutchinson and Coburn a letter Thursday insisting misoprostol "helps ensure the delivery of healthy babies and helps ensure the health and the life of the mother." According to ACOG's Marsha Simon, "The unintended victim, perhaps of the [Mifeprex] approval process, has been women's access to misoprostol for the uses of labor induction and post-partum bleeding." But that argument wasn't working with RU-486 opponents. Simon's argument is simply "a cover story to promote access to abortion," according to Hart.