July 14th, 2011

The Professor, A Paxil Study & Misconduct Charges

Pharmalot

A University of Pennsylvania psychiatry professor is alleging that several colleagues - including his department chair - allowed their names to be added to a medical journal manuscript but gave control of the contents to GlaxoSmithKline. The study, which was funded by the drugmaker and the National Institutes of Health, looked at the impact of the Paxil antidepressant on patients with bipolar disorder.

Moreover, the professor, Jay Amsterdam, also claims the 2001 study, which was published by the American Journal of Psychiatry (see here), was ghostwritten by Scientific Therapeutics Information. The same firm has previously been cited for ghostwriting activities in connection with Paxil, including a book that was published in 1999 by the American Psychiatric Association (read this). The published study did not acknowledge that STI played any role.

And so, Amsterdam, 62, has filed a complaint with the federal Office of Research Integrity charging scientific misconduct. In a letter to the ORI, he alleges “the published manuscript was biased in its conclusions, made unsubstantiated efficacy claims and downplayed the adverse event profile of Paxil.” He also claims he was a co-principal investigator, but was excluded from the final data review, analysis and publication (here is the letter).

The letter accuses the published authors of engaging in scientific misconduct by allowing their names to be attached to the study, which has since been cited more than 250 times over the past decade (here is a partial list). The lead author was Charles Nemeroff, who was a poster boy for undeclared conflicts of interest among academic researchers (see this) and a purported co-author of the ghostwritten book.

Along with the letter, Amsterdam attached numerous documents that he sent as evidence that “most, if not all” of the authors were chosen by Glaxo. The documents indicate that Amsterdam, who actively enrolled many patients in the study, protested his exclusion from the review and publication to another of the authors, Dwight Evans, who chairs the Penn psychiatry department, and was his supervisor.

The protests failed. As Amsterdam wrote at one point, he was met with “radio silence” (read this). Although in one letter written in April 2001 to Amsterdam, Karl Rickels, who was chief of mood and anxiety disorders section at the Penn psychiatry department, acknowledged that, “apparently these participants never had a chance to review or even just see the
manuscript” (see here).

Rickels also wrote him that STI chose another colleague, Laszlo Gyulai, another Penn psychiatrist, as the paper’s first author and that Glaxo then decided to replace him with Nemeroff. In addition to Nemeroff and Evans, Amsterdam also charged misconduct was committed by Gyulai, who is now retired; 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.

A Penn spokeswoman writes us that an investigation will take place and both Evans and Gyulai “have been advised of the allegations in the complaint and while they believe them to be unfounded, have made clear to the university that they will fully cooperate with the investigation”. Bowden tells Nature: “I provided input that was incorporated into the manuscript…I never had any sense that the manuscript was ‘ghostwritten’.”

A Glaxo spokeswoman writes us to say that Glaxo employees were involved developing the manuscript and were listed as authors…but the “article was written more than 10 years ago and we do not have details about the development of the manuscript.” She adds that Amsterdam’s involvement in the study is noted in the acknowledgments section of the published manuscript.

“The proper use of medical writers serves a legitimate role in facilitating the timely analysis and presentation of clinical trial data for public consideration,” she writes, adding that Glaxo is committed to transparency in c. “They may assist with assembling or preparing initial drafts, tables and figures, collating co-author comments and revising the document to incorporate those comments….”

Meanwhile, the Project on Government Oversight, a watchdog group that has tracked the NIH and conflicts of interest, wrote President Obama this week to ask 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.

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