Penn psychiatrist alleges misconduct by colleagues

A University of Pennsylvania psychiatry professor has filed a complaint with the federal Office of Research Integrity charging that two of his colleagues engaged in research misconduct by allowing their names to be placed on a study published 10 years ago that was ghostwritten by a "medical communications company."

The study, which was funded by what is now GlaxoSmithKline and the National Institutes of Health, looked at the impact of GSK's antidepressant drug Paxil on depression in patients with bipolar disorder.

The complaint by Jay D. Amsterdam, 62, alleges that "the published manuscript was biased in its conclusions, made unsubstantiated efficacy claims and downplayed the adverse event profile of Paxil." It also says that Amsterdam, who was a "co-principal investigator," was excluded from the final data review, analysis and publication."

While the initial report is a decade old, Amsterdam and his Los Angeles-based attorney Bijan Esfandiari argue that the case is important because the study is still being cited in medical journals.

The complaint alleges that Dwight Evans, chair of Penn's psychiatry department, and Laszlo Gyulai, an associate professor of psychiatry, engaged in misconduct. It also names Charles Nemeroff, a psychiatry professor at the University of Miami; Gary Sachs, a psychiatry professor at Harvard University, and Charles Bowden, chair of the department of psychiatry at the University of Texas.

Meanwhile, the Project on Government Oversight, a nonprofit watchdog group that forwarded information about Amsterdam's complaint to news organizations, also wrote President Obama this week to ask that Penn's president Amy Gutmann be removed from her position as chair of the Presidential Commission for the Study of Bioethical Issues because she has not been tough enough on ghostwriting.

"We do not understand how Dr. Gutmann can be a credible chair of the commission when she seems to ignore bioethical problems on her own campus," the group said.

Evans did not return a phone call and Gyulai referred calls to the university's public relations office. In a written statement, Penn said "we take allegations of research misconduct seriously, and will investigate the matter thoroughly . . ." It said that, while Evans and Gyulai believe allegations in the complaint are unfounded, they will cooperate fully with the investigation.