The international research organization Healthy Skepticism has called on Brown University to help convince a psychiatric journal to retract the controversial Paxil trial that I wrote about in Side Effects, according to the Brown Daily Herald. The principal investigator of this multi-center study is Brown professor of psychiatry Martin Keller, the former chief of psychiatry at Brown School of Medicine.
As the Herald notes:
Healthy Skepticism expressed concern that the study, which identified the drug Paxil as an effective combatant of depression in children, “seriously misrepresented both the effectiveness and the safety” of the drug. The authors added that the study’s continued citation was harmful to children, since some children committed suicide after being prescribed Paxil.
As I’ve blogged about here, The Journal of the American Academy of Child and Adolescent Psychiatry has so far refused to retract the trial, known as study 329, despite evidence of misrepresented data, ghostwriting and failure to disclose conflicts of interest on the part of its authors.
According to the Daily Herald, the dean of the medical school has declined to comment on whether Brown has even opened an investigation into Healthy Skepticism’s contention of scientific misconduct in the study. But Paul Thacker, the former Congressional aide who investigated Keller’s conflicts of interest for the Senate Finance committee, noted that even if University officials found evidence of misconduct, “they would likely ignore them, since Keller’s research has provided a steady source of University funding,” the Herald reported. Thacker went on to say that “he does not think the University should continue to receive any federal funding if it does not publicly address the Keller case.”
In case you missed it, GlaxoSmithKline, the maker of Paxil, was hit with a massive $3 billion fine earlier this month for the deceptive and off-label marketing of Paxil and other drugs in the United States. The $3 billion settlement is intended to cover a number of criminal and civil investigations into the off-label marketing of Paxil, Avandia (its anti-diabetes drug) and seven other drugs, and is the largest recorded fine against a pharmaceutical company to date, according to The Washington Post.
As I and others have pointed out, study 329 was among the deceptive marketing materials used by the Glaxo sales force to promote the use of Paxil in children and make it into a blockbuster drug.
Full disclosure: I’m quoted in the Daily Herald article.