Thursday, September 10, 2009

FDA Panel Recommends Approval for Men 9-26

Today, an FDA panel recommended that the cancer vaccine Gardasil be approved for use in men and boys aged 9-26.

According to Anna Giuliano, an independent scientist at Moffit Cancer Center in Tampa, Florida, and the trials' principal investigator, "The data clearly demonstrates that there was a benefit to men in receiving Gardasil. Overall, we saw a 90 percent reduction in disease -- genital warts and pre-cancerous lesions -- caused by HPV in men and an 89 percent reduction in genital warts incidence.

Get that, a 90% reduction in pre-cancerous lesions for the types of cancers under study.

The FDA will likely follow the panel's recommendation. This is great news, let's be clear. This is a vaccine for some types of cancer, it's appears to be quite safe and appears to be effective in men. (As was true with women, the focus of early research has been on younger age cohorts, the lack of a recommendation for men above 26 does not mean that there's evidence against its use at ages above 26, it means that there's simply not significant data there yet.)

This is also good news epidemiologically. If you want to wipe out a virus that causes at least a half-dozen types of cancer (cancer-causing HPV strains have been linked to cancer of the cervix, throat, mouth, anus, penis and neck), and the disease is sexually-transmitted, you're going to have a lot easier time if you don't exclude half the population you're trying to protect. To be clear, I'm not criticizing caution and this phased approach to using the vaccine, but in the long run, the more the vaccine is used across wider parts of a population the more that everyone (at least anyone that ever comes into contact with anyone else) will benefit.

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