Sunday, August 22, 2010

FBI Agent, 19 Others Vote Against Narcolepsy Drug For Fibromyalgia, a Presumptive Condition for Gulf War Veterans

Written By Katherine Hobson, Wall Street Journal

(Wall Street Journal) - An FDA panel of outside experts — including an FBI agent! — voted against expanding the use of Jazz Pharmaceuticals’ narcolepsy drug to fibromyalgia, in part because of its potential as a street drug.

An illegal form of sodium oxybate is similar to the drug GHB, Dow Jones Newswires reports. As the NPR Shots Blog noted in the run-up to the meeting, GHB gained notoriety for its use as a date rape drug. Right now sodium oxybate is distributed for use against narcolepsy only under heavy restrictions, and while panel members agreed it seemed effective against fibromyalgia symptoms in some patients, they were concerned about the potential for its misuse.’s Adam Feuerstein, who live-blogged (and Tweeted) the advisory panel’s meeting, reported that an FBI agent was invited by the FDA to participate in the panel, presumably because of the questions about the drug’s way-way-way-off-label potential. She and 19 others voted no on the critical question of whether the benefits of marketing the drug to treat fibromyalgia outweighed the risks. Two panelists voted yes. (The company, obviously, said at the meeting that it believes the benefits do outweigh the risks, DJN reports.)

The panel didn’t shut the door forever on the drug, saying Jazz should keep working on it as a possible fibromyalgia therapy, DJN says. “While we are disappointed with the recommendation” of the committee, “we plan to work closely with FDA on the continuing review of our new drug application,” said Bruce Cozadd, chairman and CEO of Jazz, in a statement. The company will “carefully consider” the committee’s input as it “seeks to address the needs of fibromyalgia patients for new treatment options in a safe and reasonable way.”

The concerns about potential abuse and misuse were highlighted in the documents the FDA itself released earlier this week, in advance of this meeting. Say it together with feeling, everyone: The FDA usually, but doesn’t always, follows the advice of its advisory panels.

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