If you recently arrived from another planet and picked up a newspaper within the last few weeks, you'd think the American
population is in imminent danger of dropping dead from unsafe, untested, unmonitored pharmaceuticals. This might also be your
opinion if you are a card-carrying member of Public Citizen, or are named David Graham or Marsha Angell. But, as the saying
goes, everything you read in the paper is true except for things you know about personally. Such is the case for the drug
safety imbroglio currently surrounding the Food & Drug Administration.
Peter J. Pitts
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
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."