Public Health Recommendations

Merck & Co. is increasing efforts to market its human papillomavirus vaccine Gardasil to boys. A new ad for the vaccine notes, “Boys can be affected by HPV disease too,” and urges parents to protect “both your son and daughter.” So far, only one in four teenage girls under age 18 have completed the three-shot vaccine series, which protects against HPV strains linked to 70 percent of cervical cancers. In late 2009, Gardasil was approved for males ages nine to 26; the vaccine’s direct health benefit was reducing the risk of genital warts. But just two in 1,000 men are diagnosed with genital warts each year. “It seems like a lot of effort for little return,” said Dr. Glen Stream, president-elect of the American Association of Family Physicians. Recent research, however, shows that some of the strains targeted by Gardasil — HPV types 16 and 18 — are linked to anal cancer, penile cancer and head and neck cancers. Merck has submitted data to a CDC advisory panel in the hope of a national recommendation making HPV vaccination routine for males. A Merck trial of several hundred men who have sex with men found that three years after vaccination, three of 194 (1.54 percent) who received Gardasil developed high-grade precancerous abnormalities, compared with 13 of 208 (6.25 percent) who received placebo shots. MSM will benefit more from the vaccine’s protective effect, because their risk of anal cancer is higher than that of heterosexual men; women are even more likely to develop the cancer. But singling out MSM as a campaign target is questionable. Gardasil is most effective when given prior to the start of sexual activity. Most young men do not realize they are gay “until after they’ve been sexually active, usually with multiple partners, and then it’s much less beneficial to vaccinate them,” said Dr. Debbie Saslow, director for breast and gynecological cancers at the American Cancer Society. No clinical trials are underway to assess Gardasil’s effect on oral cancers, which are strongly affected by alcohol use and smoking.

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