Reviewer leaks confidential NEJM study to GSK

WALTHAM, Mass. A peer reviewer for The New England Journal of Medicine broke confidentiality by leaking a damaging report to GlaxoSmithKline about its diabetes drug Avandia, according to published reports.

Avandia came under heavy scrutiny after May 21, 2007, when the NEJM published online an analysis of other studies into the drug’s efficacy and safety. The results showed that the drug increased the risk of heart attack by 43 percent in people who took it for at least 24 weeks. The report garnered widespread media attention, prompting the Food and Drug Administration to issue a safety alert.

But 17 days earlier, the reviewer, diabetes researcher Steven Haffner of the University of Texas Health Science Center at San Antonio, had faxed his copy of the article to Alexander Cobitz, a GSK employee whom Haffner knew from working on an earlier clinical trial of the drug. “Why I sent it is a mystery,” an article in scientific journal Nature quoted Haffner as saying. “I don’t really understand it. I wasn’t feeling well. It was a bad judgment.”

Nancy Pekarek, a spokeswoman for GSK, says that the company did not offer any input to Haffner on the analysis, and that she was not aware of anyone at GSK informing the NEJM of the confidentiality breach. The company has said that it had already been in contact with the FDA regarding potential cardiovascular side effects when Haffner sent the report.

Sen. Charles Grassley of Iowa, who has been investigating GSK’s handling of Avandia, said yesterday that he has sent a letter to GSK asking it to detail what action, if any, the company took after receiving the advance copy. He asked GSK to provide details of when it began examining the Record results, which was a study GSK used to answer questions concerning the risks of Avandia. The study showed that Avandia was just as safe as other diabetic medications on the market.

In November, after being ordered to do so by the FDA, GSK added a black-box warning on Avandia packaging.