Did Cephalon cross the off-label line in promoting its narcolepsy drug Provigil? That's the focus of this article from Business Week Online, which mentions that J&J and Genentech also are under the microscope for potential violations. And, as is increasingly common these days, CME is one of the "promotional methods" being examined.
It is a slipperly slope, isn't it, when faculty aren't allowed to talk about a particular off-label use in their formal presentation, but they can during the Q&A. As one scientific affairs officer recently told me, they manage to slip it in somewhere. From the article:
- Cephalon on several occasions has paid Dr. Fletcher B. Taylor, a physician in Tacoma, Wash., to meet with small groups of doctors to give talks on Provigil. Taylor did an early study on his own looking at the use of Provigil in ADHD, and got positive results. He says he does not bring up the use of Provigil for ADHD in his talks, but he answers questions -- as he is permitted to do -- if one of the doctors in the group brings it up. "Usually people do ask," Taylor says. Cephalon says it never instructs doctors on what to say at such meetings.
There are other forums to get the word out on Provigil. Doctors attend sessions called "continuing medical education" aimed at providing them with the latest information on certain diseases and treatments. These CMEs are often paid for by drug manufacturers and run by independent companies that select the speakers and curriculum without the input of the drugmaker. Still, by funding CMEs on certain topics, drugmakers have a good shot at spreading news on their products to a broad audience.
Cephalon has funded CMEs that touch on unapproved uses for Provigil. One recent program focused on treating excessive daytime sleepiness in patients with Parkinson's disease. Given the limited options for treating that sleepiness, the program detailed how Provigil might be a useful therapy. The sponsor of the program, a firm called Projects in Knowledge Inc., said that Cephalon paid for the program but had no input on the material discussed.
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