A School of Medicine faculty member has been accused of signing her name to a ghostwritten study, a practice that many believe amounts to plagiarism and undermines scientific integrity.
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The nonprofit watchdog Project on Government Oversight (POGO) claims that School of Medicine associate professor Kimberly Yonkers signed her name to work that was not her own in a 2003 report on the antidepressant Paxil. POGO executive director Danielle Brian and investigator Paul Thacker sent a letter Nov. 29 to the director of the National Institutes of Health, the organization which POGO said funds some of Yonkers’ research, identifying about four separate cases of alleged ghostwriting. One of these was Yonkers’ study, which POGO claims was part of a promotion scheme by pharmaceutical company GlaxoSmithKline to increase Paxil sales. But Yonkers says she was extensively involved in writing and editing the report.
When asked about POGO’s accusation against Yonkers by the News Thursday morning, School of Medicine Dean Robert Alpern said this was the first he had heard of it. He said the administration will need to look at the allegations further before deciding whether or not to investigate.
“We will examine the situation thoroughly before we make a decision to investigate,” Alpern said.
In the letter he sent to the NIH, Thacker included documents he found after they had been made public in the course of courtroom litigation regarding Paxil.
The documents related to Yonkers’ study include the cover page of the first draft the medical publishing company Scientific Therapeutics Information produced showing favorable results of the drug, Thacker said. The draft’s cover lists the Scientific Therapeutics Information writers who prepared the document as well as Yonkers, but the published study does not credit the Scientific Therapeutics Information writers who drafted the report for their contribution, nor does it refer to their company.
Thacker said that, based on the documents included in POGO’s letter — which refer to two other studies and a textbook apparently ghostwritten and attributed to other academic medical professionals — GlaxoSmithKline used Scientific Therapeutics Information and the medical professionals attributed as authors of these texts to fuel an “extensive ghostwriting program” meant to increase Paxil sales in the 1990s.
“Companies are not in the business of funding education,” Thacker said. “They’re in the business of spending money on marketing.”
Daniel Carlat, a former spokesperson for Wyeth Pharmaceuticals, said GlaxoSmithKline seems to have used Yonkers as a “mouthpiece” to help promote Paxil.
Carlat said ghostwriting is dangerous and unethical when a medical professional includes her name as an identified author on a document written by a ghostwriter hired by a third party with a promotional agenda.
But he added that ghostwriting can be used ethically in medical publishing as long as the researcher hires someone to help write papers who reflects the researchers’ own results and conclusions.
“No one will expect the principle investigator to sit down and write up all 10 papers,” Carlat said. “So it’s certainly ethical for a researcher in that case to seek help to get important research out into the literature.”
Thacker claimed this is not, however, applicable to the case of Yonkers.
But Yonkers says she did not simply sign her name to the study.
Yonkers said she was contacted in 2002 to help GlaxoSmithKline assemble a report for publishing in Psychopharmacology Bulletin on the use of Paxil to treat premenstrual dysphoric disorder — an illness she had previously researched. Yonkers then began collaborating with Scientific Therapeutics Information to produce the report, which reviewed previous research done on the topic, she said.
In an interview with the News, Yonkers said because the report was published several years ago, she cannot remember the specific order of her correspondence with Scientific Therapeutics Information, but that she did send them text she had written about the disorder and that Scientific Therapeutics Information writers sent her an outline of the report.
When STI finally sent her a manuscript of the report, she said, she had to edit and rewrite the draft several times to produce the final report.
Furthermore, though in the copy of the report included in Monday’s letter to NIH, she said the work was “supported by an unrestricted educational grant” from GlaxoSmithKline, Yonkers said she did not receive any money from the pharmaceutical company for her involvement in the report.
SCHOOL OF MEDICINE POLICY
The Yale policy on authorship at the time Yonkers’ study was published required faculty to have contributed significantly published works in order to be listed as authors. Faculty must have been directly involved in planning or interpreting a large component of the work, writing a draft or revising its “intellectual content” and reviewing and approving the manuscript prior to publication in order to be considered co-authors, according to an email sent by Alpern on Dec. 3.
Carlat said many academic institutions have recently updated their policies regarding ghostwriting.
Yale School of Medicine is one of them.
This fall Alpern sent a campuswide e-mail informing faculty, staff and students of Yale Medical Group’s revised guidelines — now a Universitywide policy — regarding interactions between Yale Medical Group physicians and the pharmaceutical industry. The guidelines state that physicians involved in clinical activity wth pharmaceutical companies should not be listed as authors of articles related to this research unless they make a “substantive contribution” to the articles’ content.
Alpern said the Provost has incorporated the Yale Medical Group’s updated authorship guidelines into the Universitywide policy. Both University and Yale Medical Group policies now explicitly prohibit ghostwriting, which is defined as the “practice of being named as an author on an article that contains substantial portions written by someone who is not listed as an author.”
Though these guidelines now explicitly outlaw ghostwriting, Alpern said he believes the Yale University policy has always regarded ghostwriting as inappropriate.
“We don’t sanction ghostwriting,” Alpern said. “I don’t condone it.”
According to a study published in February by the journal PLoS Med, 13 of the top 50 medical schools in the U.S. have an explicit policy against ghostwriting.