Penn professor accuses colleagues of research misconduct

A University of Pennsylvania psychiatry professor has filed a complaint with federal officials alleging that two of his colleagues, including the chair of Penn's psychiatry department, 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, funded by what is now GlaxoSmithKline and the National Institutes of Health, looked at the impact of Glaxo's antidepressant drug Paxil on depression in patients with bipolar disorder.

The complaint filed Friday 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 adds 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.

Esfandiari called Amsterdam "a man of integrity" who hopes to prevent future abuses. Such articles can be used to promote off-label use of drugs, he said.

The complaint was filed with the federal Office of Research Integrity. It 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 Amsterdam's complaint to news organizations, wrote President Obama this week asking that Penn 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.