News Analysis: The Marvelous And Unapproved Condom

By Todd Heywood

IC Editor's note: Story has been updated May 15, 2014 to include links to research discussed.

It's the HIV prevention gospel. Use a condom, correctly and consistently each and every time you have sex.

But what if that message is myth? New information shows that for anal sex, the gospel may in fact be flawed. Latex or other synthetic male condoms have never been approved by the FDA for use in anal sex. Not once. Not ever.

FDA officials say that's because no condom manufacturer has ever submitted a medical device application for such approval. Submissions require not only the submission, but science to support the approval.

And until just last year, there were not studies showing the efficacy of correct and consistent condom use in anal sex. That's when a researcher from the CDC released a review of condom efficacy in anal sex. Her findings? Correct and consistent use of condoms in anal sex every time prevents seven out of ten HIV infections. That reflects the findings of a 1989 study, the only other condoms in anal sex efficacy study. But the researcher also found that not using condoms 100 percent of the time resulted in an efficacy 4.4 percent better than never using condoms at all.

That study also found one in six men who have sex with men reported using condoms 100 percent of the time. This is much worse than other studies which show about half of men who have sex with men didn't use condoms in their last episode of anal sex.

Obviously, experts say, these findings do not mean throw caution to the wind and stop using condoms. They are an effective tool in preventing HIV infections; however they are not as effective as the condom gospel would have everyone believe.

This news raises another concern. Recommending medical devices and medicines for a use the FDA has not approved is called "off-label use." As a result, condom manufacturers are prohibited from promoting or advertising the use of their condoms in anal sex.

Medical practioners can recommend off-label use, but they cannot do so with the support of the manufacturer. That is exactly what is happening in Michigan and across the country. Public health officials are continuing to preach the condom gospel because CDC funding for HIV prevention and sexually transmitted infection work require condom messaging.

That makes condoms unique in Michigan. Angela Minicuci, spokesperson for MDCH - which oversees all HIV programming, STI programming and the state's Medicaid program - says the department does not recommend any other medical device or medicine for off label uses. Just condoms.

So why is there a dearth of science related to anal sex and HIV transmission prevention over 30 years into the epidemic? Blogger Josh Robbins published the text of a 1987 statement to Congress by former Surgeon General C. Everett Koop. The document shows the statement was edited to avoid referring to anal sex, instead focusing only on vaginal sex. And the FDA website cites Koop from 1987 saying anal sex was "too dangerous."

There was once an attempt to get condoms approved for anal sex. Reality condom manufacturers - the company that created the "female" condom, an internal condom - submitted information to get a similar internal pouch condom for anal sex approved in the early 1990s. It was rejected. But reality, the "female" condom was approved.

On condom studies, the 1989 cohort study: The only large longitudinal study of condom efficacy in gay men was published back in 1989.Its findings were affected by the sexual risk behaviour paradox we noted above. The Multi-AIDS Cohort Study (MACS), the oldest HIV cohort study in the world, found that, amongst 2914 initially HIV negative gay men, the six-month incidence rate in men who claimed 100% condom use was 0.7% and amongst men who never used condoms it was 2.9%. This yields a condom efficacy of 'never' versus 'always' of approximately 70%, somewhat lower than that seen in studies in heterosexuals, probably because anal sex is less forgiving of occasional exposure. However the six-month incidence in men who 'sometimes' used condoms was 4.3%, meaning that men who seroconverted were 79% more likely to sometimes use condoms than not to use them at all. Again, this is probably because men who never used condoms were likely to include monogamous men and ones who had less anal sex. Actual study: Detels R et al. Seroconversion, sexual activity, and condom use among 2915 HIV seronegative men followed for up to 2 years. J Acquir Immune Defic Syndr 2:77-83, 1989
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