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Men's Health News: FDA Approves Gardasil for Boys and Young Men

By L. K. Regan

This week the Food and Drug Administration (FDA) decided to approve the vaccine Gardasil for use in boys and young men. Gardasil prevents human papillomavirus, but was originally approved only for use in women, who can contract cervical cancer from the virus. The same virus causes genital warts, however, and can cause anal cancer in gay men who have receptive anal sex with an infected partner. Gardasil's approval for men may lead to lower infection rates—and potentially greater awareness around this important men's health issue.

Human papillomavirus (HPV) will infect the majority of men at some point in their lives. There are some 100 variants of the virus, most of which will have no discernible effect on an infected person. A few strains of the virus can be seriously destructive, however, causing genital warts and cancer, and it is against the four most aggressive of these strains that Gardacil protects. Until now, Gardacil was only FDA approved for use in women, since HPV causes the vast majority of cervical cancers. This week the FDA expanded its approval of Gardisil's efficacy to genital warts in men. Since one percent of sexually active American men have genital warts at any given time, this is a substantial number of men who might be impacted. (Note that HPV is transmitted by skin-to-skin contact, not fluids, so a condom, while it offers some protection, will not completely prevent HPV.)

The FDA's advisory committee voted seven to none (with one abstaining vote) that Gardasil was effective in preventing genital warts, and seven to one that it was safe for males aged nine to 26. In making their decision, the committee reviewed three studies of Gardasil's effectiveness that involved more than 5,000 boys and men in three countries. The studies found that Gardasil was 89 percent effective in preventing genital warts, though less so in people who had already been exposed to HPV—hence the young age of the approved category, which targets men before they become sexually active.

The FDA was particularly considering Garadisil for preventing genital warts, but while warts are the primary way in which HPV impacts men, they are not the only way. The same virus that will cause cervical cancer in women will occasionally cause cancer elsewhere in men: penile cancer; anal cancer in receptive partners in anal sex; or throat cancer in receptive partners of fellatio. Clearly, some men are more at risk than others. Gay and bisexual men are 17 times more likely to develop anal cancer than heterosexual men. And men with HIV—many of whom are gay—are more likely to have very severe cases of genital warts or to develop anal cancer than HIV-negative men (95 percent of HIV-positive men have some form of HPV). All of which means that gay men may want to consider a Gardisil injection. Unfortunately, at nearly $400 for a three-shot series, it isn't cheap, and it remains to be seen which insurance carriers will cover it.