Wednesday, December 1, 2010

Government oversight agency calls on NIH to ban ghost-writing

Much has been written about the insidious practice of ghost-writing in medical research in this and other blogs and news articles. Even Dr. Francis Collins, the director of the National Institutes of Health (NIH), expressed dismay over the problem in a C-SPAN interview last year, calling it a threat to the "integrity of science." So far, however, not much has been done to curb such abuses.

In an open letter to the NIH yesterday, the Project on Government Oversight dialed up the pressure on Collins and the NIH by calling attention to several particularly egregious examples of ghost-writing. In the first, two psychiatrists, Dr. Charles Nemeroff and Dr. Alan Schatzberg, (whose ties to the pharmaceutical industry and conflicts of interest have been well-publicized) signed their names to a psychiatric textbook for primary care physicians that was in fact ghost-written by a contractor for SmithKline Beecham, now known as GlaxoSmithKline. As Duff Wilson reports in The New York Times, not only did SmithKline pay for the contractor to develop the outline and text for the two named authors but in emails obtained by PGO and the Times, the contractor also said it planned to show drafts and page proofs of the book to the drug company for sign off and final approval. Yet such company control was never disclosed in the textbook, which doesn't come as any particular surprise, since Nemeroff and Schatzberg have a history of failing to fully disclose their ties to the drug industry; see here.

Another ghostwriting example that the Program on Government Oversight highlights in its letter to NIH is one that I exposed in Side Effects: that a study of Paxil, spearheaded by Dr. Martin Keller, then chief of psychiatry at Brown University, was in fact ghost-written by the same contractor that ghost-wrote the psychiatric textbook mentioned above. According to documents that I obtained and posted here, this particular clinical trial, known as study 329, was skewed to downplay the suicidal risks of Paxil in adolescents and to make the drug seem more effective than it really was. According to email correspondence obtained by a law firm suing Glaxo, the contractor also sent this study to the drug company for final approval before it was published. In Side Effects, I quote an employee of Brown's department of psychiatry saying, “Everybody knew we had to keep [SmithKline] happy and give them the results they wanted."

While Keller has stepped down as chair of psychiatry at Brown, he remains a full professor there and is still receiving lucrative NIH grants. As the PGO letter notes, "Currently, [Keller] is the primary investigator on two NIH grants, with funding in 2010 of $1,341,493. Over the last five years, the NIH has given Dr. Keller $7 million in grants."

This is unacceptable. Keller has been accused of manipulating scientific data not only in my book but in scientific journals as well; see here and here. It's high time that the NIH stepped up to the plate and did as the Project on Government Oversight asked: "implement new policies that will require institutions to ban ghostwriting and make NIH funding contingent upon periodic certification from institutions that ghostwriting is strictly prohibited..."

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