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Avandia Problems Should Result in Stop of Clinical Trial: Consumer Group

According to www.pharmalot.com, Public Citizen's Health Research Group is requesting an order to stop TIDE study. The clinical trial is comparing the health effects of GlaxoSmithKline PLC's Avandia with Actos, a diabetes drug distributed by Takeda Pharmaceuticals.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, and Dr. David Juurlink, a Toronto researcher, made the request in a letter to the FDA on May 11, 2010. The letter urges Commissioner Margaret A. Hamburg to immediately stop the TIDE study because "It is difficult to imagine that a patient would willingly participate in a trial involving a drug that, according to the American Diabetes Association and its European equivalent, has safety concerns that leave it with no present-day role in the management of type 2 diabetes."

In recent months, the movement to remove Avandia from the market altogether has grown, and defense of the drug by the manufacturer, GlaxoSmithKline PLC, has withered as sales have continued to diminish in the United States.

We handle Avandia cases and are still accepting new cases. If you or a family member took Avandia and you believe may have suffered a heart attack or death, please contact the head of the pharmaceutical practice area, Todd Hageman.

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