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General News    H4'ed 9/21/10

The Rise and Fall of Provigil - Part II

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Evelyn Pringle
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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.

However, in an editorial in the same issue, Dr Robert Basner, director of ColumbiaUniversity's Cardiopulmonary Sleep and VentilatoryDisordersCenter, said the researchers' data showed only slight improvements in workers wakefulness and productivity with Provigil, and the drug seemed to exacerbate insomnia for some patients.

"That's not a very robust endorsement of the drug coming from the investigators themselves," Basner wrote. "This drug is little better than nothing in terms of making them less sleepy during shift work at night."

For the February 2007 program, "20/20" wanted to find out how well Provigil worked in studies not funded by Cephalon, which led them to the sleep labs of the US Army and research psychologist, Nancy Wesensten, who studies drugs to help soldiers stay awake.

In studying Provigil for the army, Wesensten compared it to caffeine in terms of how well soldiers performed on tests, how alert they were, and side effects. "In our hands, at the dosages we tested, modafinil did not work any better than caffeine," she told 20/20.

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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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