CARNAL NATION

Bloomberg reports that Gardasil, a vaccine used against cervical cancers caused by the human papillomavirus (HPV), has been found to be effective in preventing or reducing the risk for genital warts in boys and men. The vaccine, manufactured by Merck & Co., is currently only approved for use in women; however, the Food and Drug Administration (FDA) will hold a public meeting on September 9 to discuss its safety in men and boys. Gardasil and other HPV vaccines are already approved for use in males in more than 40 other countries worldwide.

In a study funded by Merck and published last year, 4,065 boys and men ages 16 to 26 received either the vaccine or a placebo. After 30 months, only three men in the vaccine group contracted genital warts compared with 28 men in the placebo group. The vaccine may also be effective in preventing penile cancer due to HPV, but the FDA is not scheduled to consider this particular indication for the vaccine at this time. If approved for use in males, Gardasil could be used in more than 350,000 boys and young men next year. Gardasil is already a U.S.-recommended routine vaccination for girls beginning at age 9. Gardisil is administered in three injections over a six-month period at a cost of $400.

More than 20 million Americans are infected with HPV, which has been linked to the development of cervical, penile, anal, and throat cancers. Appoximately 1 percent of men infected with HPV will develop genital warts, and there are 1 million cases of genital warts reported in the U.S. each year. Genital warts can lead to the development of cancer. Vaccination of both sexes with Gardasil and other similar vaccines may also have a prophylactic effect against HPV, either by preventing or retarding its transmission during sex.

[Update: On September 9, the FDA Advisory Committee decided to recommend the approval of Gardasil for use in boys and men.]