What is the real goal?
What is it with Avandia and reports being leaked to the media prior to publication? Today we learned of yet another study critical of Avandia that was reported on the Pharmalot blog. Just as the now famous meta-analysis that created this whole mess was leaked prior to publication, this latest report also suggests that Avandia increases the risk of adverse cardiovascular events.
Given that Avandia sales have fallen to the bottom of the ocean and the drug has been discredited, Diabetic Investor wonders why scientists continue to press forward doing more research. Exactly what good is going to come from all this? Will patients receive better treatment because of all this, unlikely. Will the FDA take even longer and be even more cautious when approving new treatments for diabetes, this is an unqualified YES. Has this attention increased patient awareness making them more compliant with the therapy regimen or given patients even more reasons not to be compliant; studies have shown this controversy has made patients even less compliant.
Just as the initial meta-analysis that marked the beginning of the end for Avandia, this study done by an FDA scientist will likely make matters worse for not just GlaxoSmithKline (NYSE:GSK) but the FDA as well. The fact is that any physician that continues to prescribe Avandia is either downright stupid or has lost all touch with reality. Given there are alternatives such as Actos there is no reason to keep patients on Avandia. Based on all available evidence one has to wonder why any insurance company would continue reimbursing for Avandia prescriptions.
Unless the FDA plans to recommend criminal charges be filed against GSK, why don’t they just get on with it already and pull the drug from the US market. That would only make sense, save time and save money. No, instead the FDA continues to allow their dirty laundry to be seen by all and once again we’ll have another round of public criticism that will only further discredit this already discredited agency.
This getting beyond ridiculous, at a time when patients and the physicians that treat them need more not less options to fight diabetes, the FDA continues to waste time and resources pursing an issue that’s already been decided. Just what do they really hope to accomplish here? What possible good will come from all this? Isn’t time to move on to more important matters?
The reality of the situation is everyone associated with this controversy should be ashamed of their behavior. While the initial goal may have been noble, this has now become a mess that has gone too far. Frankly there are no winners here and as has become all too common the biggest loser of all are the millions of patients with diabetes who need more not less options to treat their diabetes.
While everyone else is pointing fingers and trying to get their names in the papers or faces on television, patients continue to suffer. The agency that is supposed to protect them is dysfunctional, concerned more about protecting their turf than doing what’s right and in this case obvious. Diabetic Investor would like to say we’re surprised by all this, but we’re not. The sad fact is patients continue to get the short end of the stick.