A University of Pennsylvania psychiatry professor has accused his department chairman and four colleagues of publishing an article that was ghostwritten on behalf of a pharmaceutical company and made unsupported claims for one of its best-selling drugs.
The medical-journal article, published in 2001, "was biased in its conclusions" and "made unsubstantiated efficacy claims and downplayed" negative side effects of the antidepressant drug Paxil, according to a complaint filed by lawyers for Jay D. Amsterdam, a professor of psychiatry at Penn.
Dr. Amsterdam's complaint was filed with the Office of Research Integrity of the U.S. Department of Health and Human Services, which investigates allegations of misconduct in federally financed medical research. The research cited by Dr. Amsterdam was supported both by the National Institutes of Health and by the maker of Paxil, now known as GlaxoSmithKline.
An article reporting the research appeared in the June 2001 issue of the American Journal of Psychiatry with eight listed authors. The complaint accuses five of them: Dwight L. Evans, a professor and chairman of psychiatry at Penn; Laszlo Gyulai, an associate professor of psychiatry at Penn; Charles B. Nemeroff, a professor and chairman of psychiatry at the University of Miami; Gary S. Sachs, an associate clinical professor of psychiatry at Harvard University; and Charles L. Bowden, a professor and chairman of psychiatry at the University of Texas Health Sciences Center at San Antonio.
The other three authors—Ivan P. Gergel, Rosemary Oakes, and Cornelius D. Pitts—are not identified by any affiliation in the published article. They are GlaxoSmithKline employees, said Paul D. Thacker, an investigator with the Project on Government Oversight, a nonpartisan watchdog group.
Penn, in a written statement of response, said it took the allegations seriously and would investigate them. "Both Penn faculty members 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, which they hope will be resolved expeditiously," the university said.
The allegations by Dr. Amsterdam, who has been on leave from the Penn medical faculty since August 2010, represent the latest incident in a series of cases in which GlaxoSmithKline has been accused of overstating the benefits and understating the risks of Paxil, and university researchers, including Dr. Nemeroff, have been accused of helping them.
It's also the second recent case involving the University of Pennsylvania. The Project on Government Oversight, or POGO, last November produced evidence of four instances of federally financed researchers' signing their names to journal articles favorable to Paxil that were written by a company paid by GlaxoSmithKline.
One of the four cases concerned an editorial in a 2003 issue of Biological Psychiatry that listed its authors as Dr. Evans and Dennis S. Charney, then an NIH official and now dean of the Mount Sinai School of Medicine, in New York. POGO obtained e-mail correspondence in which Sally K. Laden, an author affiliated with the medical-writing company Scientific Therapeutics Information, pressed a GlaxoSmithKline official for payment for having written the article for Dr. Evans. The published article had credited Ms. Laden with providing only "editorial support."
Sharply Worded E-Mails
POGO, in a letter to President Obama, asked that he remove Amy Gutmann, president of the University of Pennsylvania, from her position as chairman of the Presidential Commission for the Study of Bioethical Issues, until the two cases involving Dr. Evans are fully investigated and resolved.
A spokesman for the Department of Health and Human Services declined to comment directly on the future of the bioethics panel, but said in a written statement that the Office of Research Integrity would review the complaint submitted by Dr. Amsterdam.
The University of Pennsylvania also promised a review. "We take allegations of research misconduct seriously," Penn said in its statement, "and will investigate the matter thoroughly under the university's and the School of Medicine's well-defined processes and procedures."
Documents obtained by POGO show that Dr. Amsterdam, in a series of sharply worded e-mails with his colleagues at Penn in 2001, repeatedly complained about being omitted from the list of authors of the article that appeared in the American Journal of Psychiatry. In the complaint filed this month by his lawyers, he contends that "data from his study was effectively stolen from him, manipulated, and used in a ghostwritten article" designed "to advance a marketing scheme by GlaxoSmithKline to increase sales of Paxil."
A university official, speaking on the condition of anonymity, cast doubt on the primacy of Dr. Amsterdam's role in the study. Dr. Amsterdam did enroll the largest number of patients in the study, but only in a supporting role after other researchers in charge of the trial had had trouble finding enough recruits, the official said.
The published article, which noted Dr. Amsterdam only as a contributor, "was biased in its conclusions, made unsubstantiated efficacy claims, and downplayed the adverse event profile of Paxil," he said in his complaint to the Office of Research Integrity.
Karl Rickels, a professor of psychiatry at Penn who at the time headed the department’s Mood and Anxiety Disorders Section, said in one 2001 e-mail to Dr. Amsterdam that the university researchers listed as participants apparently "never had a chance to review or even just see the manuscript" prepared by GlaxoSmithKline.
Dr. Nemeroff declined to comment. Dr. Bowden said he was traveling and couldn't immediately discuss the matter, though he said all authors listed on the 2001 study had roles that would warrant their inclusion. Dr. Amsterdam and the other researchers he named in his complaint did not immediately respond to requests for comment.
A spokeswoman for GlaxoSmithKline, Sarah Alspach, said the cases cited by POGO were too old for the company to have significant information on the circumstances of its participation. GlaxoSmithKline's financial support for the 2001 article was noted in the publication, even though the company affiliation of three of its authors was not, Ms. Alspach said.
"This article, of course, was published 10 years ago," she said. "Under current standards, their affiliation with GSK would be noted."
The article's findings, suggesting that Paxil may be beneficial in the treatment of bipolar depression, have now been cited in "hundreds of medical-journal articles, textbooks, and practice guidelines," Dr. Amsterdam’s complaint says.