April 12, 2005
The new report -- which was prepared at the request of Sen. Tom Coburn (R-Okla.) -- criticizes FDA for not publicizing scientific evidence and information showing that nonoxynol-9 does not protect against HIV. "Since FDA is still in the process of completing warning label changes for N-9 vaginal contraceptive products and condoms, the public may be left in doubt about the appropriate uses of these products until FDA finalizes these warnings," the report says, adding, "Further, the public may be at risk if the products are used inappropriately." FDA said it could not comment on the GAO report or proposed label changes, the Post reports.
"The FDA is derelict," Coburn said, adding, "They've known nonoxynol-9 increases your risk of HIV, and every day they don't put that out they are harming people." He also said that FDA and CDC have an "institutional bias" toward "safe sex rather than responsible sexual activity," adding, "My definition of responsible sexual activity is monogamy with limited partners and delayed onset of sexual activity." In the past, Coburn has encouraged health agencies to "cast condoms in a dramatically different light," saying that public health officials should warn consumers about the misuse of condoms and their failure rates for preventing pregnancy and STDs, according to the Post. For example, Coburn has said that no evidence exists to show that condoms protect against certain STDs, including human papillomavirus, which causes most cases of cervical cancer (Washington Post, 4/12). NIH in 2001 released a report saying that there is insufficient evidence that male latex condoms prevent transmission of STDs other than HIV and gonorrhea (Kaiser Daily HIV/AIDS Report, 6/20/01).
Some Companies No Longer Use N-9
The World Health Organization and UNAIDS also have raised concerns about the use of nonoxynol-9 in condoms. As a result, several companies -- including SSL International, the maker of Durex condoms; Johnson & Johnson, which makes K-Y brand personal lubricant; and Mayer Labs, which makes the Kimono brand of condom -- have stopped manufacturing condoms with nonoxynol-9 (Kaiser Daily HIV/AIDS Report, 1/21/04).
Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2004 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.