Having served as associate commissioner at the agency responsible for regulating more than 30 percent of the US economy, I find the accusations that the FDA has a cavalier attitude toward safety to be untrue, unfair, unjust—and just plain revolting. It was only last year that Nobel Laureate Milton Friedman said FDA was "obsessed" with safety. And that "obsession" is rightly viewed as a badge of honor. At FDA, science rules, and safety is mission-critical.
Truth be told (because it's about time that it was), the circus surrounding the recall of Vioxx demonstrates three important things. The first (contrary to C-SPAN bloviating) is that the system works. The second is that the general public (along with some of our elected officials) doesn't understand how FDA works. And third, the twin terms of "safety" and "risk" need to be more clearly communicated to both physicians and patients.Strange as it sounds, one of the reasons that the vox populi, which heretofore considered FDA to be the world's gold standard for safety and effectiveness, has morphed into the Vioxx Populi, is precisely because the system works—but is misunderstood.
Is there a drug safety problem? Is it systemic? Or are we simply coming up against the difficult fact that drugs have both benefits and risks, and that safety is in the eye of the beholder? Is it a problem that the most crucial, appropriate, and responsible arbiter of safety for both indicated and off-label usage is the prescribing physician? When it comes to patient trust, it shouldn't be a choice between politics and public health, but those battle lines are being drawn. Unfortunately, complex systems—even ones that work—make for bad media coverage, while simplistic, dramatic demagoguery makes for sexy headlines and potent fund-raising letters. As Winston Churchill said, "A fanatic is one who can't change his mind and won't change the subject." Responsible regulators and physicians can't afford that luxury.
Americans woke up on the morning of the Vioxx recall and were shocked to discover that drugs have risks. How was that allowed to happen!? Prior to the one for Vioxx, most drug recalls didn't affect the average American—but almost everyone knows someone on a COX-2 drug. So all of a sudden safety is a relative concept? When did that happen? Ignorance may be bliss, but it's also no excuse—particularly not for those who know (or should know) better. Churchill defined democracy as "the worst form of government except for all the others that have been tried." The same can be said for FDA.
And, as if on cue, a congressional inquiry, a disgruntled employee qua whistle blower, a press corps smelling blood in the water, tort lawyers throwing blood in the water, and a cry to reform FDA! Only in America.
There's an apt Japanese proverb that bears repeating: "Don't fix the blame. Fix the problem." Unfortunately, the recent FDA-bashing isn't about making things better. It's about making headlines, making money, settling old scores, and generally pursuing various agendas—none of which is designed to "make drugs safer."