Dithering as usual at the FDA

A conference on safety concerns regarding the abortifacient Mifeprex yields more questions and no answers.


Page Rockwell
May 12, 2006 4:17AM (UTC)

The Food and Drug Administration held its long-promised meeting to discuss the abortion pill Mifeprex today, but in true FDA style, the discussion generated more meandering disagreement than scientific consensus.

To recap: The FDA is investigating the deaths of several women who suffered toxic-shock-inducing infections of Clostridium sordellii bacteria after taking the drug. Anti-choice activists and lawmakers have piously insisted that, to protect women, the drug really should be banned from sale. Choice advocates have agreed that women's health and safety are paramount and the FDA should hop to determining whether the pill is safe, while cautioning against hasty backlash.

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Complicating the debate is the fact that the deadly bacterium has reportedly killed more women who didn't take Mifeprex than women who did. As the Associated Press noted yesterday, women's health experts say at least 11 women have died from Clostridium sordellii infections after giving birth or suffering miscarriages -- one woman even died of an infection related to her period. A conference participant further reported today that the Veteran Affairs Medical Center in Boise, Idaho, has seen 43 patients with Clostridium sordellii (31 of whom died), and only half the cases were women -- five of whom had taken Mifeprex and nine of whom developed infections postpartum.

Panelists at the FDA confab discussed Brown professor Ralph Miech's research suggesting that Mifeprex suppresses the immune system, leaving women who take it vulnerable to infection. (Clostridium sordellii is estimated to be present in the vaginal canals of 4 to 10 percent of women.) But since pregnancy also suppresses the immune system, it's hard to assess whether nonsurgical abortion poses a greater risk to women than just being pregnant. Mifeprex might pose an additional risk, since the drug induces contractions that could cause bacteria to be drawn into the uterus -- but then, being in labor might carry the same risks.

Ultimately, panelist Dr. Joseph MacGregor cited surgical abortion's lower risk of death compared with nonsurgical abortion (odds are around one in 80,000 versus one in a million), and recommended that mifespristone be limited or banned. National Right to Life employed predictable, only ostensibly pro-woman bluster. And former FDA Office of Women's Health head Dr. Susan Wood, who quit in protest of the administration's effective filibuster of Plan B, said the problem was likely a general Clostridium sordellii issue rather than a specific Mifeprex issue. At the end of the day, it was business as usual; as the FDA's Dr. Sandra Kweder said, "I don't think there's a consensus."

So, once again, the FDA is failing to answer women's questions on reproductive health. Tune in next week for the congressional hearing on a possible Mifeprex ban.


Page Rockwell

Page Rockwell is Salon's editorial project manager.

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