Posted On: July 20, 2011 by Carey, Danis & Lowe, L.L.C.

Paxil Study Accused of 'Unduly Promoting the Drug'

The drug-industry’s influence when it comes to medical research writing has been a controversial issue for some time, and another debate erupted on the University of Pennsylvania’s campus this week when a new Paxil study conducted by GlaxoSmithKline was accused of bias and unduly promoting Paxil.

It all started when a psychiatry professor accused several colleagues of letting their names be included in the manuscript even though the controlling party was Glaxo, the makers of the controversial antidepressant Paxil. Professor Jay Amsterdam is also claiming that the manuscript was actually written by a contractor (ghostwriter) that wasn’t mentioned in the credit. The manuscript can be located at C. Nemeroff et al. Am. J. Psychiatr. 158, 906-912; 2001.

"The published manuscript was biased in its conclusions, made unsubstantiated efficacy claims and downplayed the adverse-event profile of Paxil," Amsterdam’s lawyer said in a letter to the Office of Research Integrity (ORI) on July 8. ORI is responsible for investigating any misconduct when it comes to gathering and posting research findings with the U.S. Public Health Service agencies.

Documents in support of Amsterdam’s complaint claim that Glaxo specifically chose which of his colleagues to include in the study to give it some credibility and to ensure that the document would place Paxil in a good light. Karl Rickels, a psychiatrist who was not involved with the study, has said that "apparently ... (academic) participants never had a chance to review or even just see the manuscript before it went to press."

While it is no wonder that Glaxo would want to promote studies that downplay the negative side effects associated with Paxil, the act itself has been condemned. In total, 5 authors were accused by Amsterdam: Dwight Evans, department chair; Charles Nemeroff, chairman of psychiatry at the University of Miami in Florida; Laszlo Gyulai, retired psychiatrist at from the University of Pennsylvania; 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.