Thursday, May 11, 2006

Bacterial Infection in Medical Abortion Cases May Occur More Broadly, Scientists to Discuss Mechanisms and Safety

I'm not finding an announcement on the CDC or FDA websites, but according to reports, scientists are scheduled to meet today to discuss the safety of RU-486 and the C. sordelli bacteria that was previously associated with recent deaths of medical abortion patients (see previous post for related and background material).

From the CNN/AP coverage:
  • "Scientists from the U.S. Centers for Disease Control and Prevention, National Institutes of Health and FDA are meeting Thursday in Atlanta to decide what research is needed to better understand the emerging threat posed by C. sordellii and a second bacterium, Clostridium difficile. The second germ is not linked to the abortion pill but is growing in prevalence in hospitals and nursing homes, and is increasingly resistant to antibiotics."

  • "The risk posed by C. sordellii remains murky. In studies and letters published in the New England Journal of Medicine in December and April, researchers detail eight other women who died of C. sordellii infection after giving birth, vaginally or by Caesarean section. Also counted are two additional deaths following miscarriages and a final death linked to infection during the woman's menstrual period. 'That's 11 other cases that have nothing to do with abortion -- they're other obstetric events,' said Dr. Beverly Winikoff, a women's health advocate who worked to bring the abortion pill to the United States.

  • "The abortion pill might suppress the immune system, which would increase susceptibility to bacteria already present in the vaginal canal, according to a study published last year by Dr. Ralph Miech of Brown University. However, pregnancy naturally suppresses the immune system, too. Dilation of the cervix, whether because of abortion, childbirth or miscarriage, also may let bacteria penetrate deeper into the body, Miech and others have proposed."

  • "In addition to the highly publicized deaths, the FDA said it has received reports of 950 cases of adverse reactions to the pill, including 18 cases of severe infections in women who required hospitalization and antibiotics. Nearly 600,000 women in the U.S. have used Mifeprex since its approval in 2000, according to Danco Laboratories. An estimated 1.5 million other women in Europe have used the drug."


    From the New York Times coverage:
  • "Some scientists say the vaginal insertion may introduce bacteria along with the drug. After examining many studies, the F.D.A. in 2000 approved a protocol that requires women to take misoprostol orally. But abortion providers have instead instructed women to insert misoprostol vaginally. 'The tablets are small, and women don't necessarily know where their vagina begins and ends,' said Dr. Phillip G. Stubblefield, a professor of obstetrics and gynecology at Boston University. If women are not careful, Dr. Stubblefield said, they can easily drag the tablet across the perineum, between the rectum and vagina, and contaminate the vagina with the bacteria. Other experts dismissed the contamination idea. 'I'm still using the vaginal route,' said Dr. Mitchell Creinin, director of family planning at the University of Pittsburgh."

  • "Dr. James McGregor, a visiting professor of obstetrics and gynecology at the University of Southern California, said RU-486 might make women more susceptible to Clostridium sordellii in part because the drug may inhibit mechanisms that moderate immunity. In cases of toxic shock, the body's immune response becomes lethal."


    From the Washington Post/Reuters coverage:
  • "Dr. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America, said the meeting should not drift into politics.'This meeting ... needs to be focused on the science,' she told Reuters.

    Still, it has drawn the attention of conservative groups who say there is enough evidence to ban the drug.

    'We hope this is just a first step,' Concerned Women for America President Wendy Wright said.

    Dozens of U.S. lawmakers, mostly Republican, back legislation calling for the Mifeprex's withdrawal. Three anti-abortion groups also filed a petition with the FDA in 2002 seeking its withdrawal."
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