Merck Seeks FDA Approval for Gardasil Use in Males

Prescription drug manufacturer Merck has now asked the Food & Drug Administration to approve the Gardasil vaccine for use in boys ages 9 to 26. Currently, Gardasil is administered to females to protect against HPV and cervical cancer.

Gardasil first hit the market in 2006, and was recommended for girls age 12 to 26, and due to some aggressive marketing the drug quickly became one of the companies top-selling vaccines. In 2007 sales topped $1.5 billion. Sales slowed in 2008, however, after a Harvard study showed that it wasn't cost effective to administer it to women in their 20s.

Merck has long had plans to release a vaccine for males. Men are simply not just carriers of HPV, and those men infected with HPV run the risk of developing cancer of the genitals or mouth, and genital warts. In initial testing, Merck found that Gardasil prevented 90% of cases of penile cancer and genital warts in the 4,000 males (16-26) that received the vaccine.

Before Gardasil can be made available to the general male public, the FDA has to approve Merck's request. Such a process can take up to a year to complete.

The drug is also not without controversy. Last year several reports of deaths believed to be linked to Gardasil surfaced, leading news outlets to claim that Gardasil was a factor. The Centers for Disease Control & Prevention, however, contends that the deaths are unrelated to the vaccine. There is also resentment against the vaccine, which is required for all immigrant women seeking a green card.