Web Special: Diabetes drug and conflicts of interest

So much for confidential peer review.

Last May, a controversial paper in the New England Journal of Medicine (NEJM) reported that a popular diabetes drug—rosiglitazone, sold under the brand name Avandia—substantially hikes a user’s risk of heart attack (SN: 6/23/07, p. 397). But according to an ongoing investigation by the U.S. Senate Committee on Finance, Avandia’s maker, the Philadelphia-based GlaxoSmithKline, knew about the study before it was published. The company was in possession of a leaked copy, courtesy of a scientist that NEJM had recruited for a peer review of the paper.

“The man who did this is Dr. Steven Haffner,” ranking member Sen. Charles E. Grassley (R-Iowa) reported yesterday on the Senate floor, referring to the investigation. Grassley added that Haffner, a physician with the University of Texas Health Science Center (UTHSC) in San Antonio, “confirmed to my investigators that he faxed a draft of the study to GlaxoSmithKline weeks before it was published.”

According to a statement issued late yesterday from William L. Henrich, dean of medicine at UTHSC-San Antonio, the charges have “just come to light on our campus. We are embarking on a complete investigation.” He added that if Grassley’s charges are confirmed the university expects to take “swift and appropriate action.”

Also yesterday, the senator sent an e-mail to Christopher Viehbacher, the president of GlaxoSmithKline U.S. Pharmaceuticals, asking the company to explain what actions it took after receiving the leaked study and to turn over by Feb. 15 any communications about the leak—such as documents, records, and telephone messages.

Most troubling, Grassley argues, is the reviewer’s role. By leaking unpublished data, Haffner “violated practically every tenet of independence and integrity held sacred by the major medical journals,” he says.

When Haffner received the UTHSC-San Antonio Presidential Distinguished Scholar Award last year, the university noted that, in terms of federal support, he is among its “highest-funded investigators.” He also received some $75,000 for consulting and speaking fees from GlaxoSmithKline, according to government filings that Grassley’s team uncovered.