Penn prof files complaint over ghostwritten Paxil study

A University of Pennsylvania professor has opened up a big can of worms with accusations that 5 psychiatrists, including one Harvard Medical School professor, lent their bylines to a journal article but ceded control of the content to drugmaker SmithKline Beecham. The ghostwriting allegations involve an article suggesting that the antidepressant Paxil might work as a treatment for bipolar depression.

In an official complaint filed with the U.S. Office of Research Integrity, Penn's Jay Amsterdam said the 5 doctors allowed a medical writing firm, Scientific Therapeutics, to pen the journal article under their names. The complaint states that SmithKline, now part of GlaxoSmithKline, did not allow all the named authors to review the article before publication. The paper was published in 2001; Paxil was first approved as an antidepressant in U.S. in 1992.

"The published manuscript was biased in its conclusions, made unsubstantiated efficacy claims and downplayed the adverse-event profile of Paxil," Amsterdam's lawyer wrote in a letter to the ORI.

In a statement in response to Amsterdam's complaint, GSK says that its employees were involved in drafting the article and the company financially supported the study, the Harvard Crimson reports. The company also said that, as a general rule, the primary authors of a paper have final approval and that "substantive assistance" from employees is disclosed. "This article was written more than 10 years ago and we do not have details about the development of the manuscript," the company said. "GSK is committed to complete transparency regarding clinical and case studies."

Massachusetts General Hospital, where one of the named psychiatrists works, says it is looking into the allegations. "Massachusetts General Hospital takes allegations of research misconduct very seriously and will handle the matter in compliance with our policy to determine if there's any validity to the complaint," spokesperson Kristen Stanton told the Crimson. Meanwhile, the University of Pennsylvania is also investigating; one of the 5 accused is the chair of its psychiatry department.

- read the Crimson article
- check out the Nature coverage

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