Remove Diabetes Drug Avandia From Market: FDA... (tific evidence and a recommendation by a...)

Remove Diabetes Drug Avandia From Market: FDA Documents

Date:2/20/2010

tific evidence and a recommendation by an independent advisory committee of experts convened by the FDA, the agency has ruled that Avandia remain available to patients for the treatment of Type 2 diabetes."

In the wake of the controversy, the drug company had been directed by the FDA to conduct a trial comparing rates of heart attacks, strokes and heart-linked deaths among users of Avandia, Actos or a placebo. But according to internal documents accessed by the Times, Graham and Gelperin characterized the study, called TIDE, as "unethical and exploitive," with patients being given Avandia despite the fact that it appears to come with greater risks and no added benefit over Actos.

One of the Graham/Gelperin reports -- dated October 2008 -- concludes that, "Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable."

However, other FDA officials overruled those concerns and TIDE is still enrolling patients, with preliminary results expected by 2014. Responding to the criticism, GlaxoSmithKline noted Saturday that, "TIDE has been approved by an independent review board and appropriate safety boards that are responsible for assessing the safety of conducting the trial."

The ongoing controversy has dampened patients' and physicians' enthusiasm for Avandia. According to the Times, while sales of the drug topped $3.2 billion in 2006, those numbers plummeted soon after the first studies suggesting risk emerged a year later.

Still, "hundreds of thousands" of people still take Avandia, the Times noted. GlaxoSmithKline's patent on the drug expires in 2012.

More information

Find out more about diabetes care at the American Diabetes Association.

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