Gardiner Harris has GSK all but sued...no big surprise there since the trial attorneys have been putting together their game plan for months. But Avandia off the market?
Maybe I and others are fighting an uphill battle and Avandia will get creamed. Certainly the number crunchers take a "take no chances" approach to the TZDs which would mean depriving people of use of these drugs based on a fear of uncertainty which is in turn based on a lack of data. I think in this environment that might be enough to crush the TZD's into a purgatory.
What is disgusting is the double standard -- accusing the FDA of not acting fast enough when it is apparent that the process of constructing long term trial and evaluating it takes a long time and raising second guessers and sloppy studies from Nissen and Graham to heroic standards.
For what it's worth here are comments from other reviewers that sparked hope that the FDA might, just might, show some cojones....
"Finally, the observation that longer term studies in the meta-analysis had similar risks between rosiglitazone and comparators highlights the importance of looking to these long-term controlled studies to confirm this finding..."
And in a nod that some folks in the FDA know the value of a real world studies compared to churning claims data (that's you, long suffering Dr. Graham)....
"The interim results (mean followup of 3.75 years) from RECORD show that 6% of patients in the rosiglitazone group and 11% of patients in the metformin + sulfonylurea group have been switched to insulin.
The protocol does not specify the rationale for discontinuing rosiglitazone upon initiation of insulin, but the most likely explanation is that combination rosiglitazone and insulin therapy is contraindicated in the European Union.
Exposures to rosiglitazone may be longer than exposures to the comparator drugs (metformin and sulfonylurea), because rosiglitazone-treated patients can be treated with three oral anti-diabetic agents before switching to insulin whereas the non-rosiglitazone treated patients initiate insulin upon failing dual combination therapy"
This amendment was added because some patients strongly expressed reluctance to initiate insulin therapy. The protocol does not discuss how study personnel should manage other CV risk factors during the course of the study (e.g., blood pressure, lipids, and the use of aspirin). Because this is an open-label trial, differential management of these CV risk factors in the rosiglitazone and non-rosiglitazone treated patients could bias results."
In other words, insulin and Avandia combos were being avoided in the real world to begin with. As for the other risks, it would appear they are manageable by physicians but they may never get the chance and neither may GSK.
The killer is not the drug, its the politics of uncertainy. It's the risk of lawsuits and the limited tolerance of risk which I predict will drive up overall death due to diabetes if the SSRI policy by fear model applies here.
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