FDA Approves Gardasil Vaccine to Prevent Anal Cancer in Men

[emeraldize]

 
FDA Approves Vaccine to Prevent Anal Cancer in Men;
GMHC Commends FDA for Policy Change Based on Science

Washington, DC -- On December 22, 2010, the Food and Drug Administration (FDA) approved the human papillomavirus (HPV) vaccine, known as Gardasil, for boys and men ages 9 to 26 to prevent anal cancer. Previously, Gardasil had only been approved for girls and women ages 9 to 26 to prevent HPV, the virus that can lead to cervical and anal cancer. The FDA's move is a great stride forward in preventing anal cancer in high-risk populations, including people with HIV and gay and bisexual men. 
 
HPV is thought to be the cause of 90% of anal cancers. Anal cancer is a rare cancer in the U.S., with an average of two cases per 100,000. However, gay men are 20 times more likely than the general population to get anal cancer, and HIV-positive gay and bisexual men are up to 40 times more likely than the general population to develop anal cancer.
 
In early 2009, in its federal policy agenda, Gay Men's Health Crisis (GMHC) called on the FDA to thoroughly evaluate Gardasil for prevention of anal cancer in boys and men. In November 2010, the FDA's Vaccines and Related Biological Products Advisory Committee convened to address this issue and voted in favor of implementing the change. GMHC was one of a small number of organizations to provide testimony at the convening in favor of the new policy.
 
"We commend the FDA for acknowledging the severe impact of anal cancer, especially among gay and bisexual men living with HIV," said Marjorie J. Hill, PhD, Chief Executive Officer of GMHC.  "We look forward to working with the FDA to ensure thorough access to Gardasil so that all young men and women can benefit from the vaccine."
 
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GMHC is a not-for-profit, volunteer-supported and community-based organization committed to national leadership in the fight against AIDS.  We provide prevention and care services to men, women and families that are living with, or affected by, HIV/AIDS in New York City.  We advocate for scientific, evidence-based public health solutions for hundreds of thousands worldwide.  For more information, please visit www.gmhc.org.