So far, media reporting on the Avandia vote has been mostly accurate, but (IMHO) there are too many folks being quoted as to "why was this drug approved in the first place?" Such citations miss the entire point and further grease the skids downwards into the Land of the Precautionary Principle.
That being said, the 30,000 foot issue is -- Can the FDA own safety?
(The short answer is that it must -- and must work immediately with skill and diligence to achieve that goal.)
At present, politicians and pundits (not to mention trial lawyers) own safety. They're the ones talking about it. They're the ones the media goes to when they write about it. Have a look at a sampling of today's Avandia press coverage and see who's quoted and what they're saying.
The struggle over control of the drug safety story is, shall say, not going the right way for the agency.
And what about the role of Big PhRMA, the other group being flayed with the safety knout? What have we heard from them on the issue of safety? Some, but not enough.
Americans woke up the morning after the Vioxx recall and were amazed to discover that drugs have risks. Good lord. Who let that happen! Avandia, in that respect, was Son of Vioxx. And, like any sequel, new actors were brought in to spice up the story.
Truth be told (because itâ€™s about time that it is), the current "safety circus" demonstrates three important things. The first (contrary to political bloviating and various and sundry pilings on) is that the system works. Can it be made better? Of course. Must it be made better. Absolutely. The second is that the general public (and, it seems, some of our elected officials) doesnâ€™t understand how FDA works. And third, the twin terms of â€œsafetyâ€ and â€œriskâ€ need to be more clearly communicated to both physicians and patients (otherwise known as â€œconsumers").
Who does that and how it is done is where the rubber meets the road. After all, as the saying goes, everything you read in the paper is true except for those things you know about personally. Such is the case for the drug safety imbroglio currently surrounding the Food & Drug Administration.
When it comes to patient trust, it shouldnâ€™t be a choice between politics and public health â€“ but those battle lines are being drawn. Unfortunately complex systems make for bad media coverage, while simplistic, dramatic demagoguing makes for sexier headlines and potent fundraising letters.
Thereâ€™s an apt Japanese proverb that bears repeating â€“ â€œDonâ€™t fix the blame. Fix the problem.â€ Unfortunately, the recent FDA-bashing isnâ€™t about making things better â€“ itâ€™s about making headlines, making money, settling old scores, and generally pursuing various agendas â€“ none of which are designed to â€œmake drugs safer.â€
It's time for the grown-ups to step forward and take charge of the debate on drug safety.