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Researcher Alleges Paxil Study was Ghostwritten

Jul 21, 2011 | Parker Waichman LLP

Five psychiatrists, including a Harvard doctor, have been accused of scientific misconduct for allegedly allowing their names to appear as authors on a ghostwritten Paxil study, though the article's content was in actuality controlled by the drug's maker.  The allegation was made by Dr. Jay Amsterdam, a psychiatry professor at University of Pennsylvania, who has filed a complaint with the U.S. Office of Research Integrity.

Amsterdam's complaint names Dr. Gary Sachs of Harvard-affiliated Massachusetts General Hospital, as well as Dr. Dwight Evans, chairman of the psychiatry department at the University of Pennsylvania; Dr. Laszlo Gyulai, associate professor of psychiatry at University of Pennsylvania; Dr. Charles Nemeroff, chairman of the psychiatry department at the University of Miami; and Dr. Charles Bowden, chairman of the psychiatry department at the University of Texas.

The Paxil study in question was published in the American Journal of Psychiatry in 2001, and purported to show that the antidepressant was an effective treatment for bipolar disorder.  According to the Boston Globe, the study has since been cited in hundreds of medical journal articles, textbooks, and practice guidelines.

According to Amsterdam's complaint, which was filed on July 8, a company called  Scientific Therapeutics Information was hired by SmithKline Beecham, now GlaxoSmithKline, to write the Paxil article.  That fact was never revealed to readers.   Amsterdam, who was a "co-principal investigator," was excluded from the final data review, analysis and publication."   He further alleges that the named authors were not able to review the article before publication.  According to a letter written by his lawyer and submitted to the U.S. Office of Research Integrity, the published article was "biased in its conclusions, made unsubstantiated efficacy claims and downplayed the adverse-event profile of Paxil."

Emails Amsterdam submitted with his complaint also suggest that Scientific Therapeutics was deeply involved in publication of the research, the Boston Globe said.

In a statement responding to Amsterdam's allegations, Glaxo said:

"The proper use of medical writers serves a legitimate role in facilitating the timely analysis and presentation of clinical trial data for public consideration. They may assist with assembling or preparing initial drafts, tables and figures, collating co-author comments and revising the document to incorporate those comments. Given the workloads of clinical investigators (external and internal), manuscripts might not be written in a timely manner absent the project management-like functions of medical writers."

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