The University of Pennsylvania has concluded that the chairman of its psychiatry department and a colleague let their names be listed among the authors reviewing a medicine in a journal article that was actually written by the drug’s manufacturer.
The university, however, has decided to take no punitive action against the chairman, Dwight L. Evans, and an associate professor of psychiatry, Laszlo Gyulai, for the 2001 article in The American Journal of Psychiatry. Penn noted that the article was published before new university rules and journal standards expressly forbidding ghostwriting went into effect.
The actions by Dr. Evans and Dr. Gyulai did not constitute “a deviation from accepted practices as they were understood at the time,” Susan E. Phillips, a spokeswoman for the university’s medical school, told The Chronicle in a written statement.
The university reached the decision after an internal investigation of several months that followed a complaint against Dr. Evans and Dr. Gyulai by a fellow professor of psychiatry at the medical school, Jay D. Amsterdam. The federal government’s Office of Research Integrity is now reviewing what action it might take in the case.
The matter is among a series of high-profile ghostwriting allegations in recent years, prompted in many instances by lawsuits from patients who claim harm from a medical treatment and then work to trace the chain of research that led to professional acceptance of a particular drug or device.
Ethics experts outside the University of Pennsylvania acknowledged the toughening of rules in recent years but questioned the degree to which that should absolve a case of ghostwriting. The International Committee of Medical Journal Editors, which sets authorship guidelines, revised its rules in 2009 to make clear that listed authors should have made “substantive intellectual contributions” to an article. The University of Pennsylvania also has tightened its authorship rules since Amy Gutmann became its president, in 2004.
Those revisions mean authors writing in 2001 were subject to different rules than would be applied now, said Lisa S. Lehmann, an assistant professor of medicine and medical ethics at Harvard University. “On some level,” she said of the university’s rationale, “there is some truth to that.”
Yet written rules might not be the only standard that could be applied, said Dr. Lehmann, who serves as director of the Center for Bioethics at Brigham and Women’s Hospital. Dr. Lehmann said she was not familiar with the details of the University of Pennsylvania case and could not comment directly on it. But she said students in grade school are taught the basic ethics of plagiarism. Even before the rule changes in recent years, she said, “there’s some common-sense expectations about what it means to put your name on a paper.”
Dr. Lehmann’s counterpart at the University of Pennsylvania, Arthur L. Caplan, said he doesn’t comment on colleagues at Penn. But Mr. Caplan, a professor of medical ethics and director of the Center for Bioethics at Penn, spoke out against ghostwriting as early as 1999. A reader “has a right to expect that the person whose name is on an article in a scientific journal is the person who wrote it,” he said in a report in a July 1999 issue of The Lancet.
A Call for Common Sense
In this instance, Dr. Amsterdam said his complaint had been motivated by his exclusion from the published study even though he felt he had initiated the research project. He produced e-mails and other documents showing that the June 2001 article in The American Journal of Psychiatry, which he described as overstating the benefits and understating the risks of the antidepressant drug Paxil, had largely been produced by GlaxoSmithKline, the maker of Paxil.
The journal article listed eight authors. The first five were university researchers, including Dr. Evans and Dr. Gyulai. The last three were employees of a medical-communications company hired by GlaxoSmithKline, whose affiliation was not stated.
The article has been cited hundreds of times in other journal articles, Dr. Amsterdam said in a complaint to the Office of Research Integrity. Eliot L. Spitzer, while serving as New York’s attorney general, reached a legal settlement with GlaxoSmithKline over his contention that the company had engaged in a series of such attempts to market the drug and play down its negative effects on children, including a possible increase in suicidal acts.
Neither Dr. Evans nor Dr. Gyulai responded to requests for comment. The Project on Government Oversight, a nonpartisan watchdog group, called last summer for Ms. Gutmann to step down from her role as chairman of the Presidential Commission for the Study of Bioethical Issues until she resolved the ghostwriting allegations against Dr. Evans and Dr. Gyulai. The group also cited evidence that Dr. Evans was involved in a separate ghostwriting episode in 2003.
Ms. Gutmann declined to resign, and the Obama administration last month appointed her to a new term as chairman of the bioethics panel, which recently spent several months evaluating the ethics of American doctors who intentionally infected hundreds of people in Guatemala with gonorrhea and syphilis as part of a public-health experiment in the 1940s. Asked this week outside a conference in Houston about the university’s handling of Dr. Evans, Ms. Gutmann walked away, referring the matter to a spokeswoman.
The university’s vice president for communications, Stephen J. MacCarthy, later issued a written response in which he said Ms. Gutmann had no involvement in reviewing the case against Dr. Evans. Mr. MacCarthy also noted that new university rules require the acknowledgment of the assistance of an outside writer.
“But that wasn’t the case when this paper was written, and the university simply cannot punish someone when they complied with the rules that were in place at the time,” he said. “It would be like giving someone a traffic ticket for running a red light 10 years ago when there was no stop light until years later.”
A lawyer for Dr. Amsterdam, Bijan Esfandiari, said Penn’s conclusion defies common sense, given warnings against ghostwriting by Mr. Caplan and others well before 2001. Mr. Esfandiari said he was preparing “a detailed point-by-point response” for presentation to the Office of Research Integrity and to a U.S. Senate committee investigating the matter. A spokeswoman for the federal office said she could not comment on the status of any investigation in progress.
