Doc leaked Avandia study to GSK
Here's a new twist to the Avandia story. A peer reviewer for The New England Journal of Medicine broke confidentiality by leaking the infamous Avandia-increases-heart-attack-risk study to GlaxoSmithKline, weeks before the article was published.
That study, remember, was the opening of Pandora's box. It led to months of negative publicity, safety reviews by drug regulators, new warnings on the drugs' label, and restrictions on its use by everyone from HealthCanada to the U.S. Department of Veterans Affairs. Along the way, GSK's stock fell by 13 percent.
Diabetes researcher Steven Haffner of the University of Texas Health Science Center in San Antonio faxed his copy of the article to a GSK employee he knew. "Why I sent it is a mystery," Haffner told Nature (rather disingenuously, if you ask us). "I don't really understand it. I wasn't feeling well. It was bad judgment."
Now, Sen. Charles Grassley has fired off a letter to GSK's U.S. president, Christopher Viehbacher (photo), demanding to know what the company did when it received the study results. Did GSK, for instance, notify the NEJM that confidentiality had been breached? A company spokesperson told Nature that the company didn't give Haffner any feedback on the study, nor did anyone tell NEJM about the leak. For what it's worth, Haffner had done consulting work and speaking engagements for GSK; he declines to say how much he was paid, but Grassley says it was at least $75,000.
Avandia - Top 10 Warnings and Recalls of 2007
RStudy: Avandia breaks down bones
New Avandia warning 'a muddle'
Avandia cleared FDA by one vote
FDA adds to drumbeat of bad news for Avandia