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Paxil Study was Ghostwriten, UPenn Prof Claims

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A professor of psychiatry at the University of Pennsylvania, is accusing several colleagues of lending their names to a manuscript while giving control of the content to drug maker GlaxoSmithKline. According to Jay Amsterdam, the five psychiatrists provided their bylines to a medical journal article which suggested that the antidepressant Paxil was effective for treatment of bipolar depression.

Allegations of ghostwriting are a reoccurring concern within the medial field; since over the past years, several articles have been ousted as being heavily influenced by industry funds.

Amsterdam claims the manuscript was written in conjunction with Scientific Therapeutics Information (SIT), a medical-communications company, which was paid by GlaxoSmithKline (GSK). He also contends that the authors of the article were handpicked by the pharmaceutical company in efforts to place Paxil in a favorable light.

According to a report by Nature magazine, the article acknowledged that GSK funded the study but there was no mention of STI being employed, or that three of the co-authors were employees of the pharmaceutical company while the study was conducted.

The clinical trial compared Paxil, another antidepressant and a placebo in the treatment of patients suffering from depression as a result of bipolar disorder.

Amsterdam argues that the study enrolled enough participants to ensure researchers achieved a definitive conclusion– one that claimed positive results for Paxil and played down the side effects of the drug.

His official complaint was filed with the U.S. Office of Research Integrity and also claims that GSK did not allow the authors to review the article prior to publication in 2001.

“The published manuscript was biased in its conclusions, made unsubstantiated efficacy claims and downplayed the adverse-event profile of Paxil,” Amsterdam’s attorney wrote in a letter to.

In 2010, Amsterdam was prompted to file the complaint after Evans lent his name to an editorial written by a writer at STI who was also being paid by GSK.

The five authors accused are Dwight Evans; Charles Nemeroff, now chairman of psychiatry at the University of Miami in Florida; Laszlo Gyulai, a psychiatrist at the University of Pennsylvania who has now retired; Gary Sachs, a psychiatrist at Massachusetts General Hospital in Boston and Charles Bowden, chairman of psychiatry at the University of Texas Health Science Center in San Antonio.

Ghostwriting is an ongoing issue with GSK.

In 2010, two authors published a book on how to treat psychiatric disorders, and acknowledged they received an “unrestricted educational grant” from GSK, then known as SmithKline Beecham, reported the New York Times.

The grant paid STI to develop the outline and text for the two authors and allowed the writing company to determine a timeline for providing the authors with a draft text and final page proofs for approval.

“That doesn’t sound unrestricted to me, that sounds like they have ultimate control,” said Dr. Bernard Lo, a medical ethicist.

Lo believes medical textbooks and handbooks should indicate the writer and editor of a first draft, in order to prevent further criticism and allegations of misconduct.

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