Saturday, July 24, 2010

Why FDA Will Likely Never Approve Gardasil® For Throat Cancers Prevention


The irrepressible Matt Herper has the whole story (though not in his usual venue) -- do go read all of his fine piece -- but here is a snippet:

. . . .The vaccine manufacturers aren't terribly hot on the idea. GlaxoSmithKline says it has no plans to study throat cancer. It adds that it is "committed to providing a vaccine specifically designed to protect against cervical cancer in girls and young women."

Merck, the maker of Gardasil, seemed more interested a couple of years ago. In 2008 it funded Maura Gillison, the Ohio State University researcher who established the HPV-throat-cancer link in 2000, to do a pilot study to show that test could reliably detect HPV infection in the throat. The pilot study was successful. By early 2009 Gillison says that a larger study of the vaccine in throat cancer looked close to being green lit.

But after Merck agreed to buy rival Schering-Plough for $41 billion in March 2009, interest in a big study seemed to evaporate, Gillison says. In a statement, Merck says that "due to competing research and business priorities, we decided not to move ahead with an efficacy study at this time. . . ."

Given some of the other FDA regulatory swirl surrounding Gardasil®, I suspect it will never be approved to prevent throat cancers in men.

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