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Avandia the Defective Drug and its Maker GlaxoSmithKline Under Heat Lamp

Jul 31, 2007 | Parker Waichman LLP

Patients using Avandia do face a greater risk of heart attack, and the diabetes drug should bear the strictest Food & Drug Administration (FDA) warning possible, said an FDA Advisory Panel investigating the medication’s safety.  But the panel stopped short of recommending that Avandia be pulled from the market, even as one of its own members urged it to do so.

That member, FDA Safety Reviewer Dr. David Graham, contended that any increased cardiac risk was unacceptable.  In the past, Dr. Graham has blasted Avandia safety trails conducted by GlaxoSmithKline as being “useless”.  In his testimony, Dr. Graham argued that because most diabetes patients will eventually die from heart problems, any drug that raises heart attack risk is too dangerous.  

Avandia has been under scrutiny since May 21, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack.  During yesterday’s hearing, GlaxoSmithKline defended Avandia, saying that its own clinical trails showed that the drug posed no more risk of heart attack than other drugs.

In the past, Dr. Graham has attacked those studies, which were funded by GalxoSmithKline.  In documents he posted on the FDA website on June 26, Dr. Graham argued that GlaxoSmithKline's studies “suffer from a profound lack of statistical power” because one did not include a placebo group, and because doctors knew what drug their patients were taking.  Dr. Graham wrote that the design of the trials rendered them “useless”.

The advisory panel voted 22-1 to recommend that Avandia remain on the market.  In doing so, they asserted that the findings of the Cleveland Clinic study were not conclusive enough, especially since other trails – notably GlaxoSmithKline’s – came to different conclusions.  “We're being asked today to take a very draconian action based on studies that have very significant weaknesses and are inadequate for us to make that kind of decision," said Rebecca Killion, a diabetic and the panel's patient representative.  

Still, the panel voted 20-3 that Avandia did carry a risk of heart attack.  They recommended that the drug be given a warning label about the cardiac problems.   The panel also said that there was a need for more studies on the issue.  The FDA is not bound by any of the panel’s recommendations.

Dr. Graham, who has been outspoken in the past on safety issues surrounding other drugs like Vioxx, asserted that the panel’s decision made no sense, saying that it “violates the principle taught us all in medical school ... 'First, do no harm.'

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