Monday, July 14, 2008

The Ties that Bind (Continued)

Senator Charles Grassley (R-Iowa) is now investigating Martin Keller, chief of psychiatry and the subject of my book,Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial, according to Pharmalot.

I first wrote about Keller in a 1996 page-one article for The Boston Globe, revealing that his department at Brown had received hundreds of thousands of dollars from the Massachusetts Department of Mental Health for research that apparently wasn't being conducted. (Brown eventually returned more than $300,000 to Massachusetts state officials after they threatened to sue the university). In 1999, I published the news in The Boston Globe that Keller was earning hundreds of thousands of dollars from the very drug companies whose drugs he was studying and touting in medical journals.

My new book, Side Effects, chronicles the story of two women -- a prosecutor and a whistleblower -- who exposed the deception behind the making of the bestselling drug, Paxil. As it turns out, Keller was the principal investigator of a controversial study that was widely used to promote Paxil as safe and effective in adolescents. However, as Rose Firestein, a prosecutor for the New York State Attorney General's office, discovered, the actual data in this clinical trial showed that Paxil was no more effective than placebo in treating depression in adolescents and had far more severe side effects than the placebo did. Indeed, this particular study was one of three cited by the New York Attorney General in its landmark lawsuit accusing GlaxoSmithKline, the maker of Paxil, of “repeated and persistent fraud” in deceiving physicians and consumers about the safety and effectiveness of Paxil.

As Side Effects reveals, there is also evidence that Keller and his co-researchers misrepresented the data to make Paxil look safer than it really was. When I was researching the book, Brown said it was standing behind Keller and "the scientific integrity" of his research. Now that Congress is pointing its high beams at Brown's chief of psychiatry, I wonder if the university's tune will, finally, change.

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