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.

The statement says the university has long considered ghostwriting to be plagiarism, which is prohibited. In 2010, the university explicitly forbade ghostwriting by School of Medicine faculty.

The university said Gutmann would not comment on POGO's demand that she be removed from the bioethics commission chairmanship.

A GlaxoSmithKline spokeswoman said the company does "not have details about the development of the manuscript." Its current policy calls for acknowledgment of "substantive assistance" by a medical writer.

It said the limitations of this study, including its small sample size, were published in the American Journal of Psychiatry.

In its written statement, GSK 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."

Esfandiari said his client, who is on medical leave from Penn because of eyesight problems, did not want to do an interview. He said Amsterdam raised concerns about the study with his superiors before and after its publication, but never filed a formal complaint.

By email, Amsterdam said that he had not pursued the matter after receiving an apology from Gyulai and his supervisor, Karl Rickels, in July 2001. His interest in the case was renewed when he saw a report last November on POGO's website of ghostwriting in another study by Evans and Nemeroff.

In his complaint, Amsterdam said Rickels told him that that the ghostwriting firm, Scientific Therapeutics Information in Springfield, N.J., chose Gyulai as the paper's first author and that Glaxo then decided to replace him with Nemeroff.

Contact staff writer Stacey Burling at 215-854-4944 or sburling@phillynews.com.