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Journal Refuses to Retract GlaxoSmithKline (GSK)'s Controversial Paxil Study


1/9/2013 8:12:51 AM

Last summer, GlaxoSmithKline agreed to plead guilty and pay $3 billion to resolve criminal and civil charges in connection with off-label promotion of several drugs, failing to report safety data and reporting false prices. One infraction, in particular, concerned a controversial study that was conducted for the Paxil antidepressant. Specifically, the feds noted the drugmaker participated in preparing, publishing and distributing what was called a “misleading medical journal article” because the results misreported that a Paxil clinical trial demonstrated efficacy in treating depression in patients under age 18, when the study failed to demonstrate efficacy. The trial, known as Study 329, missed its endpoints. The allegations concerning the study had, in fact, been known for some time. Originally published in 2001, Study 329 was one of three studies cited by former New York Attorney General Eliot Spitzer, who filed a lawsuit charging Glaxo (GSK) with “repeated and persistent fraud,” alleging the drugmaker promoted positive findings, but did not publicize unfavorable data. Just the same, the Journal of the American Academy of Child and Adolescent Psychiatry had repeatedly refused to issue a retraction. After the settlement with Glaxo, however, several detractors hoped this presented a fresh opportunity to convince the journal to issue a retraction. As it turns out, the journal has again declined to do so, according to an e-mail exchange with an academic who has previously pushed for retraction. In a Dec. 21, 2012, e-mail, AACAP editor-in-chief and Yale University psychiatry professor Andres Martin wrote that the “journal’s editorial team undertook a thorough evaluation of the article, the legal settlement and related materials. The authors of the article were contacted and asked to respond to the questions and concerns raised by the settlement.

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