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General News    H4'ed 9/21/10

The Rise and Fall of Provigil - Part II

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In December 2002, Cephalon sought to expand Provigil's label to cover excessive sleepiness, without regard to the patient's underlying medical condition. However, in January 2004, the FDA approved only a narrow expansion for excessive sleepiness associated with obstructive sleep apnea and shift work sleep disorder.

Harvard professor, Dr Charles Czeisler, chief of sleep medicine at Brigham and Women's Hospital, was lead investigator in the shift-worker study, which showed Provigil kept participants awake 1.7 minutes longer than a placebo. In September 2003, Czeisler went before the FDA to lobby for approval to treat shift-workers on behalf of Cephalon.

The FDA formally approved it for shift work disorder on January 23, 2004. Less than four months later, on May 21, 2004, Science Magazine reported that Cephalon was providing $2.75 million to fund an endowed chair at Harvard Medical School to be named after Cephalon's founder and CEO, Frank Baldino, and that Czeisler would hold the chair. Baldino was also on the advisory board of Harvard, Science noted.

Czeisler published a paper in the August 2005, "New England Journal of Medicine," and claimed night-shift workers remained more alert with Provigil. "I would characterize [Provigil] as the treatment of choice with patients with shift-work disorder," he said.

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Evelyn Pringle is an investigative journalist and researcher focused on exposing corruption in government and corporate America.
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