More twists to Avandia saga

A peer reviewer for the New England Journal of Medicine leaked a damaging report on the diabetes drug Avandia before its publication, Nature journal reported today.

The reviewer, Dr Steven Haffner of the University of Texas Health Science Centre, has admitted he faxed his copy of the article to an employee of GlaxoSmithKline 17 days before the study was published on May 21 last year.

The report, a meta-analysis by Dr Steve Nissen, found that Avandia increased the risk of heart attack by 43 per cent in patients using the drug long-term.

Avandia is now dispensed with a lengthy safety alert warning of the dangers.

Haffner told Nature that he didn't understand his own actions at the time.

"Why I sent it is a mystery," he said. "I don't really understand it. I wasn't feeling well. It was bad judgment."

In a letter to GSK, US Senator Chuck Grassley, who serves on the US Senate Committee on Finance that oversees the publicly funded Medicare and Medicaid programs, stated that according to documents filed with the FDA, GSK had paid Haffner $75,000 in consulting fees and speaking services in the last nine years.

Grassley has asked to see any documents or records about the leak, including a list of GSK employees who learned of the results prior to the study's publication.

He has also requested data from GSK's RECORD trial of Avandia, an interim analysis of which was published in the NEJM on June 5 by GSK-sponsored researchers.

"Dr Haffner told Committee investigators that no one at GSK asked him to send them this study about Avandia." Grassley wrote. "Nonetheless, I am interested in what GSK did after receiving the study.

"Did GSK return the study to Dr Haffner? Did GSK contact the NEJM to report this violation of publishing ethics?

"I would appreciate a detailed description of what GSK did after receiving the unpublished study regarding one of their leading drugs."

In a statement to the Committee, Grassley wrote: "Not only did Dr Haffner breach his agreement with the New England Journal of Medicine to properly peer review the Nissen study, but he violated practically every tenet of independence and integrity held sacred by the major medical journals."

The New York Times today reported an interesting quote from Haffner to the online medical publication theheart.org, while criticising the publication of Nissen's damaging May 21 analysis.

"The three major medical journals are becoming more like British tabloid newspapers - all they lack is a bare-chested woman on page 3," Haffner was quoted as saying.

A spokeswoman for the NEJM told Nature that peer reviewers who break confidentiality are banned from future reviewing and from contributing editorials and review articles.