Dissecting Merck's "Gardasil for Boys" FDA Application
Merck has filed an application with the FDA for the use of the HPV vaccine Gardasil in boys. The move was predicted by BNET on Nov. 14. It will likely spur two debates, one over the safety of the vaccine and another over whether Gardasil is actually cost-effective enough to be required by the government.
The safety debate has been clouded by lousy media reporting and shrill activism. Multiple studies have shown the vaccine to be safe, but journalists occasionally use outdated information suggesting it’s not.
The more interesting debate is over cost-effectiveness. In boys, HPV is largely symptomless and non-fatal, raising the question of whether it’s worth treating at all. In girls, it’s not symptomless and occasionally fatal, but not fatal enough to make the dollar numbers show a clear benefit in favor of vaccination.
One interested party that definitely sees this as cost-effective is Merck. As BNET noted recently, Merck’s vaccine divisions are struggling to get product out the door, and they need extra indications for drugs that are mandated and often funded by government. That is why you will continue to see a drumbeat of stories featuring data that show Gardasil could be effective for boys, and for increasingly yucky diseases.
Here’s one, right on schedule! The Star Gazette tells us that “HPV not just a threat to women, research shows … January is Cervical Cancer Awareness Month.” The Star Gazette piece is hitting on all cylinders, because not only does it push forward the Gardasil-for-boys debate it also raises the new and unusual HPV concerns that Merck wants taken into account:
In men, HPV may cause genital warts and cancer. Although cervical cancer is more prevalent than the penile and anal cancers that arise in men due to HPV, men are nonetheless afflicted by these cancers. More common, however, are the cases of head and neck cancers in men that are linked to the virus.
Head and neck cancer? Makes me wistful for the days when it was just genital warts.
Photo by Fickr user Ciao Chow, CC.
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.
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