Avandia Study Leaked by Glaxo-Paid ReviewerJan 31, 2008 | Parker Waichman LLP
The Avandia study that touched off a firestorm over the diabetes drug’s cardiac side effects was leaked to GlaxoSmithKline ahead of its publication in the New England Journal of Medicine (NEJM). According to a report in the Wall Street Journal, a physician who was helping peer-review the Avandia article broke NEJM confidentiality rules and faxed a copy of the article to Glaxo 17 days before it was published. The physician who leaked the study has received substantial speaking and consulting fees from Glaxo, and now one law maker wants to know if this relationship played a role in the Avandia study leak.
Avandia has been a subject of controversy since May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. In June 2007, Congress held hearings to discuss Avandia and the Food & Drug Administration's (FDA) handling of its safety issues. At those hearings, it was revealed that in 2005 GlaxoSmithKline had informed the FDA of a study it had conducted that produced similar results. However, both the agency and the manufacturer felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues. Thus, the public was not made aware of the Avandia heart attack risk until the publication of the Cleveland Clinic article
It was that article that Steven Haffner, a physician at the University of Texas Health Science Center at San Antonio admittedly leaked to Glaxo. Haffner faxed a copy of the study 17 days before it was published to Alexander Cobitz, a Glaxo employee he knew from working on an earlier clinical trial of the drug.
Haffner was one of those asked by the journal to "peer-review" the Cleveland Clinic Avandia study. Major medical and scientific journals subject the studies they publish to this process, under which experts in the field assess the validity of a study’s conclusions. Peer reviewers promise to keep the research confidential until it is published.
Haffner told the journal “Nature” that he does not know why he chose to break the rules and forward the study to Glaxo, and called his conduct “bad judgment.” Whatever the reason, Glaxo used the advanced warning of the study to prepare its response to the Avandia scandal.
The news of the Avandia study leak has one Congressman asking questions. Senator Charles Grassley (R-Iowa), a ranking member of the Senate Finance Committee has written Glaxo, asking for more information on the breach of confidentiality, as well as payments Haffner received from the drug maker.
"According to documents filed at the FDA, GSK has paid Dr. Haffner around $75,000 in consulting fees and speaking honoraria since 1999. 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?"
Haffner told “Nature” that "I didn't do it to raise my income or anything like that.” But without a better explanation for his conduct, the Avandia leak will only raise more questions about the conflicts-of –interest created by drug company payments to scientists involved in drug research.