The failure of the Food and Drug Administration to update warning labels on products containing the spermicide Nonoxynol-9 may increase the risk of contracting the AIDS virus among those who use the products, analysts at the Government Accountability Office have found.
In a report scheduled for release today, Congress's investigative arm traced the confused history of the spermicide known as N-9 and took the FDA to task for not publicizing scientific evidence that it does not protect against HIV, contrary to earlier studies.
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"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 GAO concluded. "Further, the public may be at risk if the products are used inappropriately."
The FDA said it could not comment on the proposed label changes or the GAO report.
The analysis was prepared at the request of Sen. Tom Coburn (R-Okla.), who said the findings reflect an "institutional bias" at the FDA and its sister agency, the Centers for Disease Control and Prevention, toward "safe sex rather than responsible sexual activity."
In his view, "the safe-sex mantra says there are no consequences to sexual activity as long as you use a condom," Coburn said. "That's not true."
Coburn has been pressing public health agencies to cast condoms in a dramatically different light, arguing that medical experts need to warn the public about possible misuse and failure rates. There is no evidence to date, he noted, that condoms protect against certain sexually transmitted diseases, such as the human papillomavirus.
"My definition of responsible sexual activity is monogamy with limited partners and delayed onset of sexual activity," said Coburn, who is a physician. "I can guarantee, you won't get a sexually transmitted disease if you are monogamous and your partner is monogamous."
In 1988, the surgeon general announced that condoms containing N-9 might provide additional protection against HIV. Health agencies such as the FDA, the CDC and the National Institutes for Health followed suit. A decade later, however, the CDC, armed with more research, revised its guidelines, and by 2000, CDC publications warned that "N-9 may actually increase the risk of contracting HIV when used frequently."
Although the FDA reached a similar conclusion two years ago, the agency has yet to issue new warning labels.
"The FDA is derelict," Coburn said in an interview. "They've known Nonoxynol-9 increases your risk of HIV, and every day they don't put that out, they are harming people."
Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America, agreed that the FDA has a responsibility to disseminate the latest information on N-9. But she said the spermicide is safe for women who use it to prevent pregnancy.
Three years ago, Planned Parenthood stopped producing condoms with N-9 "and we stopped recommending Nonoxynol-9 in any way to protect against sexually transmitted infections," she said. "It's disappointing FDA has not taken note of the fact that in certain circumstances Nonoxynol-9 can increase the transmissability of HIV."
Problems with N-9 are not a reason to discontinue using condoms or spermicidal products, she said. According to the NIH, condoms "provide a highly effective barrier to transmission of particles of similar size to those of the smallest STD viruses."