Pharmas Market with Mike Huckman

GSK's Avandia: Analyzing The Analyzer (Dr. Nissen)

Yep, you probably could have called this one, but researchers have done an analysis of Dr. Steven Nissen's controversial meta-analysis that started the Avandia safety scare.

Their findings are published in the Annals of Internal Medicine and touted and brought to my attention in an email from a GlaxoSmithKline PR person. A meta-analysis is what one of our contacts called "a mish-mash" of a bunch of clinical trials.

Two doctors from Cedars-Sinai in L.A. did the review. In the publication, Drs. George Diamond and Sanjay Kaul say they have no financial conflicts to disclose. The pair conclude that "the risk for myocardial infarction (heart attack) and death from cardiovascular disease for diabetics taking (Avandia) is uncertain. Neither increased nor decreased risk is established."

An FDA Advisory Committee disagrees voting overwhelmingly last week that Avandia raises the risks of having a heart attack. It is now up to the FDA to decide whether that risk will be put in a so-called "Black Box" on the Avandia label--the agency's harshest safety warning. But the GSK campaign to try to prevent that has clearly begun.

Questions?  Comments?