WASHINGTON – With two new deaths linked to the abortion drug RU-486, the leading congressional opponent to the drug stepped up his call to yank it off the market, saying manufacturers have made pregnancy "a near fatal disease."
At his news conference Wednesday, Rep. Roscoe Bartlett, R-Md., held aloft a picture of 18-year-old Holly Patterson, who died after taking the drug. He urged an immediate vote on his bill, HR 1079, "Holly's Law," which would force the Food and Drug Administration to remove the drug from the market for further investigation.
"If it were any other drug company, the manufacturer would have pulled it from the market. However, RU-486’s manufacturer, DANCO was deliberately set up as a nonprofit. The last time the FDA pulled a drug from the market over the objections of a manufacturer was 1976 – 30 years ago. The FDA’s continued timid treatment is leaving American women vulnerable to deadly infections," Bartlett said.
Calling Holly's Law, "common sense legislation," Rep. Joe Pitts, R-Pa., added that "pregnancy is not a disease."
"Too many girls have been lured into the masquerade that RU-486 is an easy fix," said Rep. Jean Schmidt, R-Ohio.
Seven women in North America have died of a severe toxic reaction to the bacteria Clostridium sordellii after taking the drug.
"It's known that a certain percentage of women have this kind of bacteria hanging around in their genital tract," without causing any harm, said Michael Greene, professor of obstetrics, gynecology and reproductive biology at Harvard Medical School.
"These unlucky women had this bacteria hanging around and it climbed up into their uterus and set up housekeeping," Greene said.
Greene published a paper in The New England Journal of Medicine analyzing the earlier deaths, where he estimated that the risk of death from infection is about one in 100,000. A woman giving birth to conjoined twins is of a similar likelihood, according to several peer-reviewed journals.
This does not make the women's death insignificant.
"Whenever people are dying from elective procedures — that's significant," he said.
RU-486 is used extensively throughout France and Great Britain, with no reports of similar deaths, although there is a difference in treatment style: In the United States women typically take the second part of the medication, a companion drug called misoprostol, vaginally instead of orally, Greene said.
"It could just be a coincidence temporally and geographically," Greene said of another possible explanation.
Planned Parenthood Federation of America changed its protocol to coincide with this new information.
"Our health centers no longer provide the second drug . . . by the vaginal, only the oral or buckle," (between the gum and teeth), said Vanessa Cullins, vice president for medical affairs for Planned Parenthood.
The organization, which has prescribed the drug treatment to more than 200,000 women since January 2001, is one of the largest providers of medical abortions in the country.
"We decided to change our protocol but we definitely stand behind (RU-486) abortions," Cullins said.
To help get to the bottom of the fatal infections, the Centers for Disease Control and Prevention is holding a conference with the Food and Drug Administration and the National Institute of Allergy and Infectious Diseases this May.
"There's a lot we still don't know about that pathogen. We're bringing together the best minds on these pathogens to make better decisions," said Jennifer Morcone, spokeswoman for the CDC.
Those at the news conference were not mollified by the prospect of the upcoming conference. Deirdre McQuade, director of planning and information at the secretariat for pro-life activities of the U.S. Conference of Catholic Bishops said, "The workshop is hardly a substitute for the provisions in Holly's Law."
Capital News Service contributed to this report.