As the debate over Avandia enters its second day, more controversy is sure to erupt. With both sides clinging to inexplicable minutiae as much as they are to the major points defining this hefty FDA review, the outcome will probably say a lot about the process that leads to it. The latest salvos from Day 1?
An FDA scientist, speaking of GSK’s studies of the drug minimizing risk: You can’t trust it, and if we do trust it, we’re engaging in the willing suspension of disbelief.
GSK’s VP of Clinical Development: Our studies provide the most robust and reliable data to assess Avandia’s safety, and those studies have found no evidence to suggest the drug increases the risk of heart attack or stroke in its users.
Testimony continues today with a decision expected on whether to pull the drug or apply restrictions to its use.
Originating from Saint Paul, Minnesota, [doctorpundit.com] is a weblog about the policy of healthcare and where it intersects with politics and public opinion; it is edited by Michael Douglas, MD, MBA. Welcome, and please consider my take on what is Healthcare 2.0, complemented by a few of my thoughts on my personal avocations and guilty pleasures: music, prose, and writing. Follow Doctor Pundit via RSS above.
DOCTOR PUNDIT @ ONE YEAR | An occasional DP series from 2010 highlighting healthcare policy trends over the period from 2009-2010 in a compare/contrast format.