Judge tosses lawsuit over controversial Paxil ‘Study 329’

A judge has dismissed a legal challenge aimed at forcing Elsevier to retract a long-criticized study that concluded the antidepressant Paxil was safe and effective for teens.

The 2001 paper, published in the Journal of the American Academy of Child & Adolescent Psychiatry (JAACAP), has faced scrutiny for more than 20 years by critics who say the study has led to unwarranted and potentially harmful prescribing of the drug to youth. As we reported last October, the journal placed an expression of concern on the paper shortly after a lawsuit was filed by attorney George W. Murgatroyd III against the journal’s owner, the American Academy of Child and Adolescent Psychiatry (AACAP), and Elsevier, which publishes the title.

In his complaint, filed in the Superior Court of the District of Columbia, Murgatroyd claimed the journal is violating the D.C. Consumer Protection Procedures Act (CPPA) by continuing to “publish, distribute, and sell a fraudulent scientific article that contains material facts” that mislead the public and endanger adolescent mental health and safety. AACAP and Elsevier are profiting from the article by charging readers to buy access to the paper, according to the complaint. 

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Controversial Paxil “Study 329” earns expression of concern after critic sues publisher

After more than 20 years of criticism and calls for retraction, a journal has placed an expression of concern on a study of the antidepressant Paxil in teens that critics say has led to unwarranted and potentially harmful prescribing of the drug to youth. 

The 2001 paper, published in the Journal of the American Academy of Child & Adolescent Psychiatry (JAACAP), reported findings from a randomized trial known as “Study 329,” which concluded the antidepressant Paxil was safe and effective in kids ages 12 to 18. 

In 2012, Paxil maker GlaxoSmithKline agreed to pay $3 billion to settle civil and criminal charges that included “unlawful promotion” of the drug for adolescents, for whom the product was never approved, and allegations the company “participated in preparing, publishing and distributing a misleading medical journal article” — the JAACAP paper.  A reanalysis in 2015 found the drug was “ineffective and unsafe” for the age group studied.

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Re-analysis of controversial Paxil study shows drug “ineffective and unsafe” for teens

downloadThe antidepressant Paxil isn’t safe or effective for teens after all, says a re-analysis of a 2001 study published today in The BMJ.

The original 2001 paper in Journal of the American Academy of Child and Adolescent Psychiatry — study 329, as it’s known — helped greenlight use of the drug (generically known as paroxetine) in young people. But it’s faced accusations of ghostwriting, undisclosed conflicts of interest, and issues with data analysis since publication.

According to a BMJ feature, also published today: Continue reading Re-analysis of controversial Paxil study shows drug “ineffective and unsafe” for teens