Now, Dr. Jay Amsterdam, a psychiatrist at UPenn, has filed a new complaint with the federal Office of Research Integrity (ORI), charging that Dr. Dwight Evans, UPenn's psychiatry chair, and four colleagues (including then psychiatry kingpin Charles Nemeroff) engaged in scientific misconduct by allowing their names to be appended to a manuscript that was drafted by the same ghostwriter for GlaxoSmithKline that wrote the editorial for Evans. Amsterdam also alleges the ghost-written paper misrepresented information from a study on the use of Paxil in bipolar depression. The study in question was funded by GlaxoSmithKline and a grant from the NIMH and published in the American Journal of Psychiatry in June 2001.
In his complaint, which can be found here, Amsterdam, who was one of study 352's principal investigators, alleges that the published manuscript did not acknowledge the medical ghostwriter's contribution or the extent of Glaxo's involvement in preparing the paper. The study itself, he says, made unsubstantiated claims about Paxil's effectiveness and downplayed some serious side effects. For example, study 352 suggested that Paxil was beneficial in the treatment of bipolar disorder, when in fact it failed to show efficacy over an older antidepressant on at least one primary outcome measure. The manuscript also did not report that Paxil may have induced mania in some patients, which is a well-known side effect not only of Paxil but other SSRI antidepressants.
Dr. Amsterdam also alleges that even though he was a principal investigator of the study, he was excluded from the final data review, analysis and publication of the paper by the ghostwriter, Scientific Therapeutics Inc (STI). STI has a longstanding history of ghostwriting medical articles under contract to GSK and other drug companies. STI was the same company that ghost-wrote the notorious Paxil study 329, as detailed in Side Effects. Indeed, study 329 was included as one of the egregious examples of ghostwriting in POGO's letter to Collins last November, which I blogged about here.
Back in 2001, when Amsterdam repeatedly complained about not being included in the publication of his own study, one of the junior psychiatrists who had been named as an author in his place apologized to him, explaining that "control of the paper had been taken away from him and that GSK published the paper without circulating the draft to all the participants..." Amsterdam continued to assert that some sort of reprimand was necessary to ensure that "plagiarism" of a colleague's data didn't happen again. But his complaints were brushed off by Evans and other colleagues at UPenn.
In his letter to ORI, Amsterdam's attorney notes that even though study 352 was published 10 years ago, it continues to be referenced in medical journals, most recently as this year. He called on the Office of Research Integrity to conduct a thorough investigation to ensure that similar misconduct never happens again and to prevent further use of study 352 "to support the dangerous prescription of Paxil to patients diagnosed with bipolar depression."
And now back to Amy Gutmann. As chair of the presidential commission on bioethics, UPenn's president is supposed to be working to promote ethical behavior in scientific and medical research. Last November, when POGO released its letter to NIH citing the ghostwriting incident involving UPenn's psychiatry chair, the university student newspaper jumped on the story. At the time, a university spokesman was quoted in the student paper saying that allegations of ghostwriting in Evans' editorial were "unfounded." Yet documents unsealed in a lawsuit show evidence that STI prepared a draft of the editorial for Evans. Amsterdam's attorney sent Gutmann a copy of his official complaint last week; see here.
In its missive to President Obama, POGO writes:
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. Until the University concludes a sincere and transparent investigation of these charges and takes decisive action to deter future ghostwriting, we feel that Dr. Gutmann should be removed as Chair of the Commission.