Tropical Storm Safety

  • by: |
  • 06/23/2006

Owing to genuine concerns about pedigree and counterfeiting (courtesy of the FDA’s aggressive use of the Bully Pulpit), together with the successful rollout of the Part D drug benefit, the issue of foreign drug “re-importation” has lost much of its political allure and momentum. Most of the elected officials calling for the “legalization” of foreign drugs have since abandoned their incautious and dotty schemes. Aeternum vale!

But political bloviation abhors a vacuum. Taking the place of drugs are too expensive is the new clarion call of drugs are not safe. A sure-fire political winner. After all, who could be against “safety?” Safe = Good. Unsafe = Bad, right? Well, not exactly. As Dr. Mark Goldberger, director of FDA’s office of antimicrobial products commented, “It’s more complex than it seems at first glance.”

Safety has been hijacked. Safety is the new Re-Importation. But it’s the same old story.

And it sure plays in Peoria or, perhaps more appropriately, in Des Moines. Not surprisingly, the media loves it because; although the pressure point is different the “victim” (the patient) and “the villain” (the pharmaceutical industry) are the same. And, as everyone knows, it’s more than okay to kick the stuffing out of Big Pharma (or, if you prefer, “Big Pinata”). It’s a free hit. Sanctimonious quotes and macho strutting results in terrific headlines for the folks back home.

A little harmless politicking? Hardly. Just ask the people who no longer have access to the medicines they need (like Vioxx), or to those who will suffer needlessly in the wake of Tropical Storm Safety — since the inevitable result is a dearth of new medicines in the pipeline.

Is it safe? Ask the FDA. Is it politically safe? Ask a Senator. Is it remunerative? Ask an attorney.

What does “safe” mean, anyway? 100% safe? Certainly not. All drugs have risks as well as benefits. And more often than not the more serious the disease the more serious the risks associated with the treatment. Consider advanced non-small cell lung cancer. Then consider Iressa. Are such medicines risky? Indeed they are. Are the diseases they treat serious enough for patients to accept such risks? Decidedly. Consider Multiple Sclerosis. Then consider Tysabri.

But most importantly, consider the Precautionary Principle, the one-dimensional dogma that dictates that nothing should be done until everything is understood. Prudent? No, puerile. And the unintended consequences are fatal. Fatal like in no new medicines. Fatal like in death.

Is it time to recall Ivory Soap? Is it safe? After all, it’s only 99 44/100% pure.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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