The GlaxoSmithKline Ghostwriting Documents, Part Two
How the NIH Can Stop Ghostwriting in Commercial Research
Posted Dec 01, 2010
On Tuesday, the New York Times reported on how SmithKline Beecham paid a marketing company, Scientific Therapeutics Information (STI), to ghostwrite a medical textbook on psychopharmacology for family physicians, with Charles Nemeroff and Alan Schatzberg then signing off as authors of that textbook. The Project on Government Oversight (POGO), which is a non-profit group that seeks to "expose corruption" in the federal government, first fleshed out this story, posting documents on its website, and those documents tell of a ghostwriting enterprise that supported the selling of Paxil for more than a decade. This also was an enterprise that involved a number of prominent academic psychiatrists, who -- as the POGO documents reveal -- continue to receive large grants from the National Institutes of Health.
According to the documents posted by POGO, in early October 1993, STI laid out a ghostwriting plan to help SmithKline Beecham market its new antidepressant, Paxil. This would begin, STI proposed, with a meeting of SmithKline's "Psychiatrist Advisory Board" on November 5-7 in Palm Beach, Florida. STI had recruited ten well-known psychiatrists for the board, which was to be chaired by Nemeroff, and STI promised to recruit ten more. All of the psychiatrists on the advisory board were to be flown first class to Florida, and paid between $2,500 and $5,000 for the weekend event.
At the opening session, STI promised, Nemeroff would discuss how to "generate information for use in promotion/education" of Paxil.
Over the next ten years, SmithKline Beecham (now GlaxoSmithKline) paid STI to ghostwrite editorials, journal articles and at least one medical textbook (the 1999 text "authored" by Nemeroff and Schatzberg.) The draft of that textbook was written by two STI writers, Sally Laden and Diane Coniglio, with SmithKline Beecham signing off on the final text. Together, Schatzberg and Nemeroff have received $23.3 million in NIH funding since FY 2006.
In a November 29 letter sent to Francis Collins, director of the National Institutes of Health, POGO also detailed the following instances of ghostwriting by STI for GlaxoSmithKline.
• In 2001, STI's Sally Laden helped write a scientific article on "study 329," which was published in the Journal of the Academy of Child & Adolescent Psychiatry. In that paper, lead author Martin Keller of Brown University Medical School and 21 other prominent child psychiatrists reported that the study provided "evidence of the efficacy and safety of the SSRI, paroxetine, in the treatment of adolescent major depression." They drew this conclusion even though internal GlaxoSmithKline documents confessed that "the study did not really show [Paxil] was effective in treating adolescent depression, which is not something we want to publicize." The ghostwriters had turned a failed study into a positive one, and the academic psychiatrists signed off on that scientific fraud. Dr. Keller has received $7 million in NIH funding since FY 2006.
• In 2002, STI's Sally Laden and another STI employee ghostwrote a study for Kimberly Yonkers, from Yale School of Medicine. When STI sent the draft to Yonkers for her review, it reminded her to remove evidence of STI's involvement in writing the paper before submitting it to a journal, Psychopharmacology Bulletin. Dr. Yonkers has received $6.4 million in NIH funding since FY 2006.
• In 2003, STI's Sally Laden ghostwrote an editorial, which was published in Biological Psychiatry, for Dwight Evans, chairman of the psychiatry department at the University of Pennsylvania School of Medicine, and for Dennis Charney, who at that time was an NIH employee and today is dean of research at the Mt. Sinai School of Medicine at New York University. Evans and Charney have received $30.6 million in NIH funding since FY 2006.
The POGO documents reveal aspects of the extensive ghostwriting enterprise that supported the marketing of Paxil. The full tale of ghostwriting involved in the promotion of Paxil undoubtedly has many more chapters, which perhaps will be revealed in the future. But the point that POGO made in its letter to Francis Collins is this: Prominent academic psychiatrists signed their names to those ghostwritten papers, and yet today they continue to receive generous NIH grants.
One "would think NIH policies would prevent such practices," wrote POGO authors Danielle Brian and Paul Thacker. "You must set policies that require NIH-funded academic centers to ban ghostwriting to strengthen scientific integrity."
That seems like a reasonable solution to me. If academic scientists sign their names to ghostwritten articles, with that ghostwriting paid for by a pharmaceutical firm, then they shouldn't be allowed to subsequently obtain NIH research funds. That rule, I believe, would shut down the commercial ghostwriting enterprise quickly, much to the long-term benefit of American science.