New rules on doctors and Big Pharma

Michael Sloan

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When the "author" is a celebrity and the book is a memoir, everyone expects a ghostwriter. But when the putative author is a doctor and the publication is about pharmaceuticals, ghostwriting—especially by a pharmaceutical company—is highly controversial.

That's one of the conflict-of-interest issues addressed in a new policy adopted this summer by the Yale Medical Group (the School of Medicine's faculty practice) and the university as a whole. As it happened, not long after the policy was approved, a national watchdog group accused a Yale medical school professor of having attached her name to a ghostwritten article in 2003.

The new policy turns the school's existing guidelines (which date from 2006), plus a few additions, into binding rules. "The landscape has changed," says David J. Leffell '77, deputy dean for clinical affairs for the medical school and CEO of the Yale Medical Group. "The trend is to take a more critical and aggressive view of conflict-of-interest issues." Indeed, there has been much recent debate over the relationship between academic physicians and the pharmaceutical industry, including a U.S. Senate Finance Committee investigation. And issues that weren't even on the radar in 2006, including ghostwriting, are now hot-button topics. "We wanted to send the message that this policy reflects our values as an institution, and that if you're found to violate them, there will be penalties," Leffell says.

The policy, designed to ensure "principled interactions" between Yale clinicians and industry, places limits and restrictions on gifts, meals, consulting fees, drug samples, site access for sales representatives, industry support of continuing medical education, and authorship. It also mandates fuller disclosure and more stringent enforcement.

Other universities that have recently amended their policies include Harvard and the University of Minnesota. But one area where Yale has taken the lead is ghostwriting: only 10 of the top 50 medical schools prohibited the practice as of a February 2010 survey. Under Yale's new policy, faculty members are barred from being listed as authors unless they make a substantive contribution to the article.

In November, the Project on Government Oversight (POGO) wrote to the National Institutes of Health identifying what they believe to be four incidents of ghostwriting. Among them is a paper on the use of the antidepressant Paxil in the treatment of a premenstrual disorder. Yale physician Kimberly Yonkers is listed as author, but POGO argues that it was written by a marketing firm hired by GlaxoSmithKline. Yonkers disputed the charge, telling the Yale Daily News she was involved in writing, rewriting, and editing the paper. Medical school dean Robert Alpern says the school is "looking into the events that transpired."

While Leffell welcomes the new policy, he also acknowledges the significant role the pharmaceutical industry plays in funding biomedical research by universities. The medical school regularly receives research grants and contracts from drug companies. "It's disingenuous to suggest we don't have a relationship with the pharmaceutical industry," he said. "It's important not to paint Big Pharma as the black knight and we're the white knight. On the proper terms, we can be good partners."