Gardasil Approved for Men—But Is It for You?
Published Jan 05, 2011
Gardasil is a vaccine, developed by Merck, that defends against human papillomavirus, or HPV. This virus is incredibly common—very many of us will encounter it at some point in our lifetime, and shed it easily. But some strains of the virus can linger, and cause cancer. The virus is transmitted by genital or skin-to-skin contact and particularly easily to some kinds of mucous tissues, so Gardasil was originally approved for younger women, to prevent primarily cervical, as well as vulvar and vaginal, cancers. This is also not the first time Gardasil has been used for men—it is approved for both sexes for prevention of genital warts. That’s because HPV does not discriminate by gender, and can attack pretty much any susceptible tissue it contacts. In the anus, for example, or the throat.
That is why this FDA decision matters for gay men. Though HPV does not discriminate between genders, the drug approval process can and does. But, while anal cancer is not common in general (5,260 new cases per year, the American Cancer Society says), and while more of these cases are women than men, gay men are disproportionately represented among those stricken. So, though only 1.6 Americans per 100,000 develop anal cancer, among gay men that number is 40 per 100,000. And among HIV-positive gay men the rate is twice even that higher number. Indeed, in making its research case for FDA approval of Gardasil for anal cancer, Merck studied 602 men who self-identified as having sex with other men. And among those subjects, it found that Gardasil was 78% effective in preventing the anal cancers and precancerous lesions associated with two strains of HPV. Since HPV is associated with, by some estimates, 90% of anal cancers, getting Gardasil to gay men could make a substantial difference.
The remaining question is who, exactly, should be vaccinated. “Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. Yet vaccines cannot protect someone who has already been exposed to the cancer-causing strains of the virus. This is why Gardasil is only approved for use in people, whether men or women, aged 9 to 26.
The young age limit, along with the focus on gay men, has led to some overblown media reports suggesting that all young, gay-seeming men need to be vaccinated—or even all young men in general. But in fact, even an older man who has never been exposed to these strains of HPV may be successfully vaccinated, just as a young man considering his sexual future may want to take precautions. Hopefully, with a bit of sanity and some self-knowledge, this vaccine could be a useful tool in a responsible adult gay man’s personal health care plan.