Make no mistake, the Avandia brawl has nothing to do with science, except that in no instance have the anti-Avandia forces -- and that's what they are -- presented any evidence of a biological mechanism explaining why there might be a higher risk of heart problems. After pouring through the the 700 pages of additional data about Avandia and combining it with clinical outcomes from BARI-2 and ACCORD study -- both finding no heart risk associated with the drug -- the choice about whether to use Avandia boils down to clinical judgment and the needs of the individual patient.
As a commentary in this week's Biocentury suggests, the FDA's public hearing on Avandia being held this week is stacked in favor of Steve Nissen and David Graham, the two most public and vociferous critics of the drug. Something tells me that forces within and outside the FDA are seeking to force FDA commissioner's Peggy Hamburg's hand.
If the advisory committee votes to pull Avandia it will be hard for the FDA not to concur. And that will be the beginning of the end of the FDA's science-based regulatory authority, at least under this administration. It will mean that that marauders who react to any safety signal can run to the media and members of Congress to slow down or delay a product's approval or kill it's sales. It's means that meta-analysis, which has become a powerful data dredging tool for generating risks and diverting attention from benefits by producing spurious statistical association will triumph over biologically based outcomes.
Fearmongering requires new and unexpected risks. It must eliminate efforts to individualize treatment based on risks and benefits.
Nissen and Graham along with their fellow travelers on the one side. Dr. Hamburg and the FDA's future is on the other.
The decision on Avandia will decision which way regulatory science and the FDA will go for years to come.
As a commentary in this week's Biocentury suggests, the FDA's public hearing on Avandia being held this week is stacked in favor of Steve Nissen and David Graham, the two most public and vociferous critics of the drug. Something tells me that forces within and outside the FDA are seeking to force FDA commissioner's Peggy Hamburg's hand.
If the advisory committee votes to pull Avandia it will be hard for the FDA not to concur. And that will be the beginning of the end of the FDA's science-based regulatory authority, at least under this administration. It will mean that that marauders who react to any safety signal can run to the media and members of Congress to slow down or delay a product's approval or kill it's sales. It's means that meta-analysis, which has become a powerful data dredging tool for generating risks and diverting attention from benefits by producing spurious statistical association will triumph over biologically based outcomes.
Fearmongering requires new and unexpected risks. It must eliminate efforts to individualize treatment based on risks and benefits.
Nissen and Graham along with their fellow travelers on the one side. Dr. Hamburg and the FDA's future is on the other.
The decision on Avandia will decision which way regulatory science and the FDA will go for years to come.
