Last summer, Jay D. Amsterdam, a Penn professor who also had been involved in the study of the effect of the antidepressant Paxil on depression in patients with bipolar disorder, filed a complaint with the federal Office of Research Integrity about the study. He alleged that "the published manuscript was biased in its conclusions, made unsubstantiated efficacy claims, and downplayed the adverse event profile of Paxil."
He also was upset that he was not listed as an author.
The Office of Research Integrity, which investigates for the Department of Health and Human Services, has not announced a decision on Amsterdam's complaint, which also named professors at three other universities.
Penn has sent its report to the research office, and Bijan Esfandiari, Amsterdam's lawyer, said he planned to send a point-by-point response. Esfandiari said the report, which was not made available, supported his claim that GlaxoSmithKline, which makes Paxil, and a medical writing firm it hired were involved in writing the study.
In a written statement, Penn's School of Medicine said a faculty inquiry committee found that, "Drs. Evans and Gyulai satisfied all authorship criteria and the publication presented the research findings accurately. Drs. Evans and Gyulai performed the research, analyzed the results, and contributed to the paper." The statement pointed out that the study results were negative, a finding reflected in an article in the American Journal of Psychiatry.
The committee also concluded that "Amsterdam's contributions to patient recruitment and data collection did not meet with the journal's guidelines for authorship."
Susan Phillips, a spokeswoman for the medical school, did not respond to a question about whether the medical writing firm wrote the study or edited the researchers' writing. Though current policy would call for acknowledging that assistance in the paper, "the committee concluded that guidelines in place in 2001 did not."
Three study authors worked for Glaxo. Penn said the "manuscript submitted to the journal included the institutional affiliation of the authors, but the journal removed that information from the publication."
Esfandiari disputed Penn's claim that its investigation was "thorough." He questioned the university's claim that the professors were not guilty of any violations because ghostwriting was considered an acceptable practice at the time. He said Penn bioethicist Arthur Caplan, who does not set university policy, was critical of ghostwriting in 1999.
"It is disappointing that an Ivy League school which claims to be driven by a credo of ethics has given sanctuary to such conduct," Esfandiari said.
Last summer, the Project on Government Oversight, a nonprofit watchdog group, called for the removal of Penn president Amy Gutmann from her position as chair of the Presidential Commission for the study of Bioethical Issues because she had not been tough enough on ghostwriting. She was recently reappointed.
Joe Newman, the oversight project's spokesman, said Thursday he thought the university's statement did not go far enough. "There should be at least a strong statement that, marching forward, the university is going to hold itself to the highest standards and what happened shouldn't have happened," he said.
Penn banned ghostwriting by medical school faculty in 2010.
Contact staff writer Stacey Burling at 215-854-4944 or email@example.com.