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Merck Seeks Approval for Use of Gardasil for Men

By L. K. Regan

This month, the pharmaceutical company Merck requested Federal Drug Administration (FDA) approval for the use of its vaccine Gardasil in men. Gardasil protects against the human papillomavirus, or HPV. Whether it will gain approval for this expanded use remains unknown, as recent efforts to expand the vaccine's range have met with resistance.

Gardasil was approved in 2006 for use in girls and young women as an effective preventative for HPV. According to the Centers for Disease Control and Prevention (CDC), HPV infects some 20 million Americans, with 6.2 million new infections per year. For most people, the infection will be brief and resolve on its own. As the CDC puts it, "At least 50% of sexually active men and women acquire genital HPV infection at some point in their lives." But amongst the over 40 varieties of HPV are a group of strains that cause problems: specifically, genital warts, and cancer.

Historically, these cancer-causing strains of the virus have been the leading cause of cervical cancer in women, who are encouraged to be tested annually with a Pap-smear to check for the presence of problematic cervical cells as a result of the virus. Both men and women are at risk for genital warts from HPV (though the strains of the virus that cause warts are different from those that cause cancer). It is a less well-known fact that men are also at risk for cancers as a result of HPV, though these cancers are less common than the cervical variety. HPV infects mucous membranes and skin. It can take up residence, therefore, anywhere where there is skin-to-skin contact. So, gay men are at risk for anal cancer from HPV, and HIV+ men are particularly at risk. A study conducted in 2005, in fact, found that 95 percent of HIV+ men had HPV, and 50 percent of them had lesions that are known precursors to anal cancer.

Gardasil, Merck's vaccine for HPV, which protects against the four most common cancer and wart-causing strains, has only been approved for use in young women—until now. Last year, Merck requested expansion of the vaccine's approval to include older women. Last week, the FDA delayed a judgment on that request pending the completion of a trial testing the vaccine on women aged 27 through 45. Since Merck anticipates submitting those results late this year, there is not likely to be an answer until 2010. Meanwhile, Merck has foundered on disappointing sales of the drug which, after an initial sales boom immediately following its FDA approval, has tapered off, despite the prevalence of HPV. Thus the pharmaceutical company has sought new customers for the vaccine, including older women, and men. Last week, after the FDA's disappointing delay of the approval for the vaccine in older women, Merck also re-assigned the vice president responsible for Gardasil, and admitted to low expectations for Gardasil's growth in 2009.

In November of last year, scientists reported at a meeting in France that Gardasil reduced genital warts and lesions among 4,000 subjects, all boys and young men aged between 16 and 26, by 90 percent. On the strength of this study and others showing similar results, Merck requested FDA approval for Gardasil's use in boys aged nine to 26—the same age group approved for girls and young women. In the UK, for instance, this use of HPV vaccines is already approved. Whether the vaccine will be approved in the US, however, remains in doubt, and unfortunately, the faltering of the approval process for older women does not encourage optimism.