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.

NOT YOUR FATHER'S FDA

Sweeping Changes in Store

It happens in small steps, but every day we learn another bit about the changes the Hamburg/Sharfstein team are bringing to an FDA saddled in dysfunction, corruption, and incapacity. Most recently, they have announced a program that would bring much more transparency to decisons on NDAs and applications for new indications that could unearth material on drugs and devices that are normally not surfaced except in litigation. Read about it in the New York Times:

http://www.nytimes.com/2009/06/02/health/policy/02fda.html?emc=tnt&tntemail1=y

After years of having to put up with an FDA leadership that wanted mostly to hide under rocks or their jockey shorts of their benefactors, it is almost difficult to believe we are seeing this much change. I still wonder how many dead-enders there are who will offer pockets of resistance--and maybe more--as reform goes on. Old and corrupt regimes die hard, as the last eight years have taught us, even at their most grotesque.

One interesting tidbit I didn't know. After the scam around the CLASS study was uncovered, and JAMA learned that it had been given the only part of the data set, the journal explicitly disowned the article. Neverthless, detailers continued to use it to sell Celebrex. I never get tired of quoting what Bob Temple said at the time: That the hype from the JAMA article will always have greater impact than our labeling does.