Steve Nissen Accused Of ‘Data Snooping’
Make a commentBy Ed Silverman // June 26th, 2007 // 7:25 am
That was the accusation made during a panel debate attended by thousands of doctors at the American Diabetes Association meeting in Chicago yesterday afternoon. The charge was leveled by Philip Home, a professor of diabetes at Newcastle University in the UK and a member of the Glaxo steering committee for one of the Avandia studies included in Nissen’s analysis.
“I think this is data snooping on quite a big scale,” says Home, who is a lead investigator on a separate, ongoing 4,400-patient trial funded by Glaxo. And while he maintains that Avandia should be part of the “glucose-lowering armoury,” he also acknowledged that a clinically significant rise in heart attacks not causing death “cannot be ruled out.”
For his part, Nissen didn’t deny being a snoop.
“The FDA rushed to approve this new (drug),” he says. “In my view that was a regulatory mistake. A strong safety signal of excess (cardiovascular events) was ignored…When you see this kind of consistency in data, it makes you believe that something real is going on…We want you and others who treat these patients to be aware of the findings…What was the alternative? Not to know? The alternative was unacceptable: to keep the scientific community in the dark.”
Sources: Reuters and CNNMoney.com
Hat tip to PharmaGossip