Margaret Talbot

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In her 2009 New Yorker article about neuroenhancers, Margaret Talbot explains the concept of “mission creep,” whereby a pharmaceutical created for one purpose is pushed into other more suspect treatment areas by drug companies looking to further monetize a product:

“The Lynches said that Provigil was a classic example of a related phenomenon: mission creep. In 1998, Cephalon, the pharmaceutical company that manufactures it, received government approval to market the drug, but only for ‘excessive daytime sleepiness’ due to narcolepsy; by 2004, Cephalon had obtained permission to expand the labelling, so that it included sleep apnea and ‘shift-work sleep disorder.’ Net sales of Provigil climbed from a hundred and ninety-six million dollars in 2002 to nine hundred and eighty-eight million in 2008.

Cephalon executives have repeatedly said that they do not condone off-label use of Provigil, but in 2002 the company was reprimanded by the F.D.A. for distributing marketing materials that presented the drug as a remedy for tiredness, ‘decreased activity,’ and other supposed ailments. And in 2008 Cephalon paid four hundred and twenty-five million dollars and pleaded guilty to a federal criminal charge relating to its promotion of off-label uses for Provigil and two other drugs. Later this year, Cephalon plans to introduce Nuvigil, a longer-lasting variant of Provigil. Candace Steele, a spokesperson, said, ‘We’re exploring its possibilities to treat excessive sleepiness associated with schizophrenia, bipolar depression, traumatic injury, and jet lag.’ Though she emphasized that Cephalon was not developing Nuvigil as a neuroenhancer, she noted, “As part of the preparation for some of these other diseases, we’re looking to see if there’s improvement in cognition.'”

Another post about Nuvigil:

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