HPV Vaccine Fails to Get Nod for Routine Use in Boys

October 21, 2009

October 21, 2009 — Despite hearing impassioned pleas to protect both men and women from cancer, a federal advisory panel today declined to recommend that a human papillomavirus (HPV) vaccine be routinely administered to boys to prevent genital warts.

Instead, the Advisory Committee on Immunization Practices (ACIP) issued a "permissive" recommendation stating that physicians have the option of vaccinating boys with the HPV vaccine Gardasil (Merck) for genital-wart protection. ACIP noted that boys should receive the vaccine "before exposure to HPV through sexual contact."

In 2006, the US Food and Drug Administration (FDA) approved Gardasil for use in girls and young women to prevent cervical and other cancers as well as precancers caused by HPV types 16 and 18. Last week, the FDA also approved Gardasil for use in males aged 9 through 26 to prevent genital warts.

In making its recommendation today, ACIP appeared to be swayed in part by published research questioning the cost-effectiveness of routine vaccination of boys with Gardasil. The committee's decision has far-reaching economic effects because third-party payers typically pay for vaccinations that are recommended for routine use, but not those coming with a permissive recommendation.

More at Stake Than Genital Wart Prevention

Proponents of routine vaccination of boys with Gardasil told the committee Wednesday during the public comment period that more was at stake than merely preventing genital warts. They underlined the need to also prevent oral, throat, penile, and anal cancers caused by HPV.

David Hastings, a spokesperson for the Oral Cancer Foundation, said his ability to hear, taste, and produce saliva was impaired after "brutal and barbaric" treatment for oral cancer, which was triggered by an HPV-16 infection. Oral cancer, he said, claimed more lives than cervical cancer, and HPV was the fastest-growing cause of this disease.

"I urge the committee to give this vaccine its strongest and broadest recommendation so that one day HPV will be eliminated as an etiology of cancer and as a killer of our children, their children, and their children," said Hastings.

Ellen Daley, PhD, an assistant professor of community and family health at the University of South Florida College of Public Health, said a recommendation for the routine use of Gardasil in boys would not only protect them from genital warts and cancer, but also female partners who might contract HPV from men during sex. "Women and girls shouldn't have the full burden of receiving the vaccine, but should share it with males," said Dr. Daley, adding that she hoped her own 16-year-old son would be vaccinated.

Jason Schneider, MD, immediate past president of the Gay and Lesbian Medical Association, told the ACIP that a permissive recommendation for Gardasil would hinder gay youth from receiving the vaccine. "For the [gay, lesbian, bisexual, and transgendered] community, the people most at risk...are the least likely to afford the out-of-pocket costs independent of [insurance] coverage," said Dr. Schneider.

However, Diane Solomon, MD, a researcher at the National Cancer Institute, said she opposed a routine recommendation for Gardasil "because we shouldn't spend money on interventions that aren't cost-effective."

"I urge the committee to keep its eye on the ball, which is the responsible stewardship of public health funds," Dr. Solomon said during the public-comment period. She noted she was speaking for herself, not for the National Cancer Institute.

The ACIP recommendation awaits approval by the US Centers for Disease Control and Prevention.

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