Questions Raised About Safety of Abortion Method

In the last couple of years, four women in California have died after undergoing abortions with a two-pill regimen that had, until recently, an unblemished safety record.

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Scientists gathered in Atlanta yesterday for a government-sponsored meeting to try to sort out something of importance of both opponents and supporters of abortion right. That's the role of medically induced abortions in the deaths of half-a-dozen women or more. By the end of the day, the only thing clear was that the situation remains unclear.

NPR's Joanne Silberner reports.

JOANNE SILBERNER reporting:

The mystery started with a report last year that four California women had died after taking the two drug abortion pill combination, Mefipristone, sometimes called RU486, and Misoprostol. They'd all died infections caused by supposedly rare bacterium called Clostridium Sordellii, just a few days after their abortions. The deaths appeared to be a horrific side effect of the drugs. But Paul Seligman of the Food and Drug Administration said it's not likely to be that simple.

Dr. PAUL SELIGMAN (Office of Pharmacoepidemiology and Statistical Science, Food and Drug Administration) But this combination of drugs is used around the world, in many more patients than in the United States. Why, then, are these are the cases only here? And why now, and only in the western United States?

SILBERNER: And how could a bacterium that been found to live harmlessly in some people, kill others?

Marc Fischer is with the Unexplained Deaths Project, a part of the Centers for Disease Control and Prevention. His job is to figure out what kills people. All he can say in these cases was what didn't.

Mr. MARC FISCHER (Unexplained Deaths Project, Centers for Disease Control and Prevention): There were no epidemiologic links identified between the patients. Each woman had received their medications from a different clinic and healthcare provider, and the medications received were from different manufacturing lots.

SILBERNER: And tests showed they weren't contaminated. As for what happened to the four California women, there were as many theories as there were panelists.

Perhaps the women weren't alone, and other deaths just went uncounted. Maybe the blood and fetal tissue passing through the vagina during the medical abortion, makes the area more prone to infection.

Esther Sternberg of the National Institutes of Health suggested one of the pills inhibits the immune response, allowing the bacteria to grow, which raised more questions. Why just this one?

Sandra Kweder of the FDA says there are a number of reasons why the mystery is going to be difficult to solve.

Dr. SANDRA KWEDER (Deputy Director, Center for Drug Evaluation and Research, Office of New Drugs, FDA): I would say that one of the things that makes it very difficult is that the cases are very rare.

SILBERNER: There have been four well-documented cases and more than 500,000 instances of American women taking mifepristone, or RU486. Several more are under investigation. All told, not enough to see a pattern. Another difficulty...

Dr. KWEDER: It's always difficult to investigate cases surrounding pregnancy or the peripartum period, a lot because of confidentiality concerns, and particularly when you get into areas of having to delve into the area of abortions. There are a lot of sensitivities around that, and so obtaining information can be a challenge.

SILBERNER: The federal authorities rely on doctors and hospitals to report the deaths and give the details. They don't have to. In the face of these difficulties, Kweder says you can't even say for sure that there is a connection between the C. sordellii deaths and medical abortion. Women have developed the infections after miscarriages and after giving birth, and there are non-pregnancy deaths as well. One panelist described a four-year-old boy who died after he broke his arm and an infection started under his cast.

Kweder says her agency, which could force the abortion drugs off the market, will now consider what it's heard, including information on two new deaths after medical abortions. One woman was infected, not by C. sordellii, but a similar bacterium called C. perfringens. The other woman had taken, not mifepristone, or RU486, but a different drug to induce abortion.

Joanne Silberner, NPR News, Atlanta.

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