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    Thursday, December 01, 2005

    Rashomon Medicine: One study, so many interpretations:

    In California, the Los Angeles Times says Study Defends Abortion Pill Safety:

    Government researchers investigating the deaths of four California women who contracted infections after taking RU-486 and another drug to induce abortion have found that the risk of infection from the controversial drug combination is 'low,' according to a study released today.

    The scientists also found nothing to link the deaths of the four women, who were prescribed the drugs at different clinics in Northern and Southern California between 2003 and 2005

    And the San Francisco Chronicle reports that U.S. calls abortion pill risk low despite deaths:

    Government investigators studying the deaths of four California women who took the RU-486 abortion pill played down the risks to other users Wednesday and said the fatal infection that caused the deaths wasn't particular to women taking the drug.

    In an article in the New England Journal of Medicine, the investigators described the risk of the Clostridium sordellii infection as low and said it could occur after taking the pill, undergoing a surgical abortion or giving birth.

    Their findings angered conservative opponents of the abortion pill who have been urging federal drug regulators to suspend sales as a grave threat to women's health. Liberals, who increasingly have worried that the Food and Drug Administration might buckle to political pressure and restrict access to the drug, welcomed the report.

    But in Boston, they see it differently - Article to kindle abortion pill fight :

    An article in today's New England Journal of Medicine could increase pressure on the Food and Drug Administration to restrict the sale of abortion pills associated with four fatal infections in California.

    As does Reuters -Abortion drugs linked to rare fatal infection. Others take a more neutral approach to presenting the study's results.

    The study is more accurately a post mortem investigation into the deaths of four young, healthy California women who died suddenly and unexpectedly after taking the "abortion pill" which is really two medications - mifepristone, known as RU-486, and misoprostol, also known as Cytotec. Mifepristone is the agent that causes the abortion to occur, and misoprostol acts to open up the door to the uterus to let the products of conception out. Contrary to the Los Angeles Times, the women all have many things in common. They all used the misoprostol vaginally instead of the FDA recommended oral route. (See also here - scroll down to the directions for use. Evidently, the non-approved route is not uncommon.) And they all died from the same infection - a fulminant clostridial infection. (Clostridia bacteria are known vaginal dwellers.)

    In the discussion section, the authors note that there have been an estimated 460,000 medical abortions in the United States, based on the sales figures provided by the company. There could have been fewer - there's no way to know how many of those sold pills were used. There have been 4 known deaths in women from sepsis after using it - an incidence of 0.0009%. No one knows how many women die from the same infection after childbirth, miscarriage, or surgical abortion, but the overall rate of death from infections of any type is lower in all three cases. For childbirth, it's 0.0007%, for miscarriage 0.0004%, and for surgical abortion 0.0002%.

    What's especially disturbing about the deaths is how easily the infection can be overlooked. All of the women presented with abdominal pain - an expected reaction to the abortion pill. Their physical exams were all rather benign. They had somewhat low blood pressures, but not low enough to be unusual for young women in their late teens and early twenties. They had mildly elevated heart rates - also not unusual for someone in pain or who might be anxious. None of them had a fever. The only way anyone was alerted to a problem was a striking increase in white blood cells on their blood work. This is not something that would normally be noted with their sort of presentation in any setting other than an emergency room, where blood work is done routinely on everyone. In a doctor's office, where lab work is usually only ordered if there's evidence for a need, a patient with no fever, a benign exam, and symptoms that would be expected after taking the abortion pill, this would likely be missed. It also is not clear that early intervention would have made any difference. All of these women died, even the ones who were on antibiotics and in an intensive care setting. The bacteria kills by producing a toxin, which is difficult to counteract.

    I know I would be reluctant to use a medication that killed four women in the prime of life. Especially when a safer surgical alternative is available. At the very least, I'd avoid the vaginal use of misoprostol and stick with the recommendations to use it orally.

    But casual readers of the San Francisco Chronicle and the Los Angeles Times might still think it's perfectly safe.

    posted by Sydney on 12/01/2005 08:57:00 AM 0 comments


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