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General News    H4'ed 9/20/10

The Rise and Fall of Provigil -" Part I

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Evelyn Pringle
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Again in 2005, when Biederman began another trial, sponsored by Cephalon, to run from September 2005 to September 2006, he disclosed no financial relationship with the firm. But in March 2008, Grassley learned that Cephalon had paid him $11,000 for honoraria in 2005, and an additional $24,750 in 2006.

In fact, all total, Biederman had earned about $1.6 million from drug companies between 2000 and 2007, but failed to report about $1.4 million on forms filed with Harvard.

In disclosures at the end of his reply letter, Biederman listed fourteen drug companies, including Cephalon. In December 2008, Mass General announced that Biederman would no longer be participating in several drug company funded trials and would limit his speaking and consulting activities, pending the outcome of an inquiry of his potential conflict of interests and disclosure obligations.

As mentioned by Kruszewski in his letters to the editor, Cephalon had applied for approval of modafinil (in a larger dose formulation called Sparlon), to treat children and adolescents with ADHD, in December 2004.

However, Biederman was out giving talks promoting off-label use with kids long before it came up for approval. On May 26, 2005, in Doctors Guide Dispatch, Bruce Sylvester reported on a May 24th presentation titled, "Modafinil Pediatric Formulation Has Early and Sustained Effect in ADHD," given by Biederman at the annual meeting of the "American Psychiatric Association," on a study funded by Cephalon and led by Biederman, which claimed Sparlon was effective for children aged 6 to 17 with ADHD.

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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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