Glaxo Letter May Have Sealed Avandia's Fate
FDA regulators had ordered GlaxoSmithKline, the makers of Avandia, to send a letter to doctors that explained the results of a hearing that took place in July. At that hearing, an expert advisory board talked about the risks of the controversial drug that is used to treat type 2 diabetes.
The letter that was produced but raised some controversy of its own when federal officials and members of the panel claimed that the letter is misleading and could cause some patients danger. This all happened only a couple of weeks before the FDA decided to use strict warnings on the labels and restrict the wide availability of the drug.
And these moves come on the heels of a trial that conducted by GSK, comparing Avandia's risks to that of Actos (made by Takeda). The study had revealed that Avandia posed the higher risk via heart attacks and strokes by its users and Avandia since has been forced into severe restrictions by the FDA after further investigations into GSK's research tactics were reported.
The letter that GSK produced at the time is said to be biased. Dr. David Graham, a medical officer at the FDA, begged that the study be stopped because he said that thousands of patients in the trial were being exploited. This is a fact that was not included in the letter.
“This summary is biased, misleading and not truthful,” Graham notes. “The whole purpose of this letter is so that they can reassess whether this is an ethical trial going forward, but the step-by-step ethical flaws and problems with the Tide trial are not even referenced.”
Many doctors on the panel have made statements that the letter was untruthful, misleading and very Avandia-friendly. As to whether this letter actually had a lot to do with the FDA's decision to apply severe restrictions on Avandia and prevent the drug from being widely used, no one can say for sure. However, with complaints that GSK blatantly hid test data, this letter certainly didn't offer a dispute.
