CDC Group Backs Gardasil for Routine Use in Males

Thanks to a CDC committee recommendation, Merck could see a spike in sales of its HPV vaccine Gardasil. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention said boys 11 years and older should be vaccinated against human papillomavirus, the sexually transmitted virus that has been linked to several types of cancer.

HPV vaccination was initially targeted toward girls and young women because of the virus' known association with cervical cancer. That market seemed to be plenty big enough: As the first HPV shot to hit the U.S. market, Gardasil quickly took off. But sales soon sputtered, partly because some adults proved squeamish about vaccinating young girls against sexually transmitted disease. The vaccinations are also expensive, at more than $100 for each of the three required doses.

Merck turned to new indications as a source of future growth. The company won FDA approval for Gardasil use in males, as a preventive measure against genital warts, and then as a protectant against anal cancer. HPV has since been linked to head and neck cancers, too. Obviously, as the associations between HPV and cancer stack up, the case for vaccination grows.

The CDC committee was convinced. But members also recognized that the new recommendation could be controversial, given the fact that the types of cancer Gardasil could prevent in males are linked to anal sex and oral sex, and many of the HPV-caused cases of these cancers are found in homosexuals.

It's unclear whether the recommendation will offer a lasting increase in sales for Gardasil. As The New York Times points out, vaccination rates for girls have been disappointing despite CDC's backing. The sex question is likely to limit uptake in boys, too; it certainly doesn't make Merck's marketing an easy task.

It's ironic that a shot protecting against several cancer types would face such a challenge, committee experts said. "This is cancer, for Pete's sake," Dr. William Schaffner of Vanderbilt University School of Medicine, a nonvoting committee member, told the Times.

"A vaccine against cancer was the dream of our youth."