MIXED MESSAGES ON GARDASIL

JAMA, FDA, CDC Speak in Many Voices

The Gardasil vaccine has been mired in controversy pretty since its introduction three years ago. Merck lobbied very hard to make the vaccine mandatory in many states, and very nearly succeeded in a number of them. Were it not for the arm-twisting/pocket-lining suggested by Merck's tactics, and the Vioxx legacy, the company would almost certainly have succeeded.

This week, we have heard a range of messages about the vaccine. JAMA reported on overall safety to date. The summary conclusion was that even the most serious events following administration of the vaccine--including about 30 cases of ALS--could not be causally linked to the vaccine. That said, a JAMA editorial raised the question of whether even this degree of risk was outweighed by the benefits of the vaccine. See

http://jama.ama-assn.org/cgi/content/full/302/7/795

In the meantime, the same JAMA article chastised Merck for promotional tactics (same old, same old) particularly through various medical societies. See Fierce Pharma's summary at:

http://www.fiercepharma.com/story/jama-gardasil-safe-promos-questionable/2009-08-19

In the wake of all of this, both the FDA and CDC have pronounced the vaccine safe for use based on current data available. But essentially no one is pushing anymore for mandatory vaccination, as was the case two years ago.