Saturday, July 22, 2006

FDA Overreaches

In a case that is sure to have far-reaching consequences, a doctor is arrested for using a drug off-label.

Off-label use of medications occurs all the time. Even aspirin, used for years as a mainstay therapy for myocardial infarction (heart attack) because of its anti-platelet effects, was never approved by the FDA for this use. And yet over the years aspirin administration in the setting of myocardial infarction has become a "best practice guideline" therapy.
"F.D.A. rules allow doctors to prescribe federally approved drugs for any purpose, even if it is not indicated on the medicine’s label. ... And at least one former F.D.A. official says that the government appears to be overreaching in going after Dr. Gleason and may chill a common and legitimate form of medical discussion. “This is a very, very scary development,” said Daniel E. Troy, a partner at Sidley Austin and the former chief counsel of the F.D.A."
This issue goes beyond drugs as well. Perhaps one of the most obvious recent examples of this was in the early-development years of catheter ablation (burning electrical short circuits in the heart using a wire threaded there through a vein). With the development of radiofrequency energy to perform catheter ablation, it was clear to doctors that therapy using steerable ablation catheters (wires) posed less risk to their patients than subjecting them to open heart surgery for the same treatment. Thousands of patients underwent catheter ablation procedures without FDA approval of the steerable ablation catheters used in the procedure. Doctors discussed the risks and benefits of these catheters for years in a public forum known as the North American Society of Pacing and Electrophysiology (NASPE). Finally, the FDA realized they could not move as quickly as medical developments and issued their "Catheter Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for Industry" document on 1 July 2002, written with the guidance of doctors who had used off-label catheters for years.

While illegal use of controlled substances should be diligently prosecuted, doctors must have the right of free speech that is unencumbered by intrusive government intervention. To do otherwise will stifle creative innovation and important public discourse in medicine.


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