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Widener Univ. School of Law

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Monday, January 14, 2008

"Drug Approved. Is the Disease Real?"

That's the provocative title of Alex Berenson's article today covering the recent FDA approval of Lyrica's new indication for fibromyalgia.  As the story notes, some researchers are not convinced that fibromyalgia in fact exists -- and suggest that calling it an official disease encourages additional complaints of pain by those diagnosed with it.  Those researchers do not question whether the patients are actually in pain, but whether it can be classified as a separate disease.

The drug in question has some interesting regulatory history that could be relevant to any future litigation:

The F.D.A. reviewers who initially examined Pfizer’s application for Lyrica in 2004 for diabetic nerve pain found those results unimpressive, especially in comparison to Lyrica’s side effects. The reviewers recommended against approving the drug, citing its side effects.

In many patients, Lyrica causes weight gain and edema, or swelling, as well as dizziness and sleepiness. In 12-week trials, 9 percent of patients saw their weight rise more than 7 percent, and the weight gain appeared to continue over time. The potential for weight gain is a special concern because many fibromyalgia patients are already overweight: the average fibromyalgia patient in the 2007 survey reported weighing 180 pounds and standing 5 feet 4 inches.

But senior F.D.A. officials overruled the initial reviewers, noting that severe pain can be incapacitating. “While pregabalin does present a number of concerns related to its potential for toxicity, the overall risk-to-benefit ratio supports the approval of this product,” Dr. Bob Rappaport, the director of the F.D.A. division reviewing the drug, wrote in June 2004.

As of today, there don't appear to be any lawyers advertising via Google's sponsored ads, though there are a number of firms who seem to be looking for clients in connection with suicidality.

--BC

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