Message Problems: One Key Lesson from the Cox-2 Advisory Panel

As important as the news that came out of the Cox-2 advisory panel hearings was the subtext: the industry's increasing loss of control over its marketing messages.

As we go to press, the dust hasn't completely settled on the remarkable three-day advisory panel extravaganza on the Cox-2s since no final decisions on the drugs have been heard from the FDA. But as important as the news out of the panel—recommendations on specific label procedures, for example, the votes recommending that celecoxib (Celebrex) and valdecoxib (Bextra) remain on the market, even the squeaker decision in favor of a rofecoxib (Vioxx) return—was the subtext: the drug industry's increasing loss of control over messaging.

This was heard in two mutually reinforcing subjects: the panel's recognition of the limited but undoubted value of observational data—the kind of non-randomized, retrospective trials drug companies and most FDA...

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