Penn Professor Accuses Colleagues of Research Misconduct

Penn Professor Accuses Colleagues of Research Misconduct [the Philadelphia Inquirer]

From Philadelphia Inquirer (PA) (July 13, 2011)

July 13--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.

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 Evans and Gyulai believed allegations in the complaint were unfounded and would cooperate fully with the investigation.

The statement says the university had 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. The commission also would not comment.

Nemeroff and Sachs did not return phone calls. While at Emory University, Nemeroff was banned from receiving National Institutes of Health grants after failing to tell the school about more than $1 million in payments from drug companies.

Bowden said that he believed a medical-writing firm was involved in the study to help with tasks such as assembling references and making sure syntax was proper. But he said that, to his knowledge, neither that firm nor Glaxo chose who the lead authors would be or shaped the final report. "This was as much in the hands of the academic collaborators in the study as one can conceive of," he said.

The study, he said, clearly stated that Paxil was not effective in most bipolar patients and is generally quoted by other scientists to show why antidepressants should not be used in this population.

A GlaxoSmithKline spokeswoman said the company did "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 journal article.

'Proper use'

In its written statement, Glaxo said: "The proper use of medical writers serves a legitimate role. . . .They may assist with assembling or preparing initial drafts, tables and figures, collating co-author comments and revising the document to incorporate those comments."

Three authors of the study worked for Glaxo and were not identified as drug-firm employees. Bowden said that information was in the study manuscript but the journal chose not to publish it.

George Annas, chair of the department of health law, bioethics, and human rights at Boston University's School of Public Health, said most journals required that firms involved in the writing of medical studies be identified.

While doctors often need editing, "there's no role for ghostwriting in medical studies, period," he said. Doctors could hire someone to help them, but they should not work with firms hired by drug companies.

"Obviously, it's not ethical to have the drug company that's sponsoring the trial write the report," he said. "Instead of getting a medical study, you get a piece of advertising."

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.

The study, which was published in the American Journal of Psychiatry, concluded that antidepressants could be helpful for bipolar patients taking low levels of lithium. Amsterdam contends that the paper did not focus on the primary outcome measure of the study: whether the drugs Paxil or imipramine were better than placebo at treating depression in bipolar patients. They were not. Instead, Amsterdam's lawyer says, smaller groups of patients were analyzed until a positive result could be found.

Mania

The paper does mention prominently that the overall results were negative.

Amsterdam also said the study did not properly analyze mania -- a potential side effect of antidepressants in bipolar patients.

By e-mail, Amsterdam wrote 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 in November on POGO's website that involved ghostwriting by Scientific Therapeutics Information of Springfield, N.J., in an editorial by Evans. That report says Scientific Therapeutics was paid by Glaxo.

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

Esfandiari said his law firm has proof that ghostwriters were involved in Amsterdam's study in sealed documents from other cases it has pursued.

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

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Posted: July 2011


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