The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will next meet tomorrow. In the afternoon session, the committee will "make recommendations on the safety and effectiveness of vaccinating males with Merck's Gardasil®, a vaccine against Human Papillomavirus. . ." (HPV). Gardasil is already approved as an HPV vaccine for women.
Merril Goozner, in an inaugural edition of what looks to be a new offering of his, discusses whether vaccinating men against HPV makes any macro-economic sense. Do go read it all, as he also offers a thoughtful analysis of the HPV vaccine's cost for women, as well:
. . . .Several Harvard researchers who recently took a look at those numbers and estimated the total health benefit including reduced cancers concluded that vaccinating young men was not a cost-effective prevention strategy. They told the CDC's ACIP committee in June that adding an HPV vaccine for young men to the government-approved schedule would cost more than $100,000 for every quality-adjusted life year (QALY) saved. That's more than twice the $50,000 per QALY benchmark usually used by health care economists to judge whether an intervention is deemed "cost-effective."Merck immediately challenged those numbers, according to Bloomberg News, which covered the meeting. But Merck used a cost of $400 per vaccination with universal protection, while the Harvard study put the cost of vaccination at $500 per child and a 75 percent protection rate. It should be noted that even the Harvard effectiveness number was more generous than the 67 percent reduction shown in the pivotal clinical trial. . . .
There is certain to be more "heat, than light" on this subject -- out of Whitehouse Station's representatives -- at the FDA's VRBPAC, tomorrow afternoon.
All the background materials (large PDF file) are now posted on the FDA's advisory committee's website.
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