In case the Canadian Medical Association Journal wasn’t clear on the harms of the RU486 drug cocktail they call “the gold standard” for abortions, this will help. Celeste McGovern, an excellent investigative journalist, had this piece a few years back. Misopristol is the drug used in combination with mifepristone to make up the RU486 regime. Misopristol was designed to address gastric ulcers, it was never intended for “pregnancy termination.”
Just weeks before the FDA approved RU- 486, G.D. Searle, the manufacturer of misopristol, issued a “physician alert” to the FDA and to every obstetrician and gynecologist in the USA, warning that misopristol “is not approved for the induction of labor or abortion.”
The Peapack, N.J.-based subsidiary of Pharmacia Inc. said that misopristol, sold under the shelf name Cytotec, was developed and clinically tested only to treat gastric ulcers. Searle warned, “Serious adverse events reported following off-label use of Cytotec in pregnant women include maternal or fetal death, uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy … amniotic fluid embolism, vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.”
The FDA, which had recommended that misopristol be used in combination with mifepristone as part of RU-486 treatment, posted Searle’s warning letter on its Web site, but did not withdraw its recommendation. The Population Council would not release a copy of the informed-consent papers women in the trial signed before taking part in the Canadian study, and Horzepa refused to say if the women in the trial were aware of the Searle letter.
Roslyn Tremblay, a spokeswoman for Canada’s federal health department, also declined to confirm if the women in the study were aware of the warning. “Within the Canadian context, any research information is proprietary information and would have to be released by the company,” said Tremblay.
But abortionist Wiebe disclosed that none of the women were informed about Searle’s physician alert.
Ellen Wiebe was the woman in charge of the first Canadian trial of RU486.
Really, where are the feminists when you need them?
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