Wednesday, July 14, 2010

Diabetes Drug Safety Under Ruling


A federal panel of advisors will take part in a series of votes this week on whether the controversial diabetes drug Avandia is safe enough to stay in the pharmaceuticals market.

The federal advisory panel was overwhelmed by conflicting information, both from the maker of Avandia, GlaxoSmithKline, and from researchers within the Food and Drug Administration. The debate is whether or not the data provided from GlaxoSmithKline's clinical trials is reliable. Federal panel advisers received evidence that participants in the trial of Avandia who were heart attack sufferers did not have their related cardio problems included in the study. Further, documents made public about GlaxoSmithKline's study show that the drug provider kept crucial data about Avandia’s safety concerns a secret.

Defective drug lawyers are already taking interest in the trials, compiling critical information that could provide valuable for future cases if the drug is to remain in the market. The questionable results from the study foreshadow the future potential for pharmaceutical drug lawyers.

FDA researchers said early this week that studies show that Avandia is much more dangerous to the heart than a comparable medication known as Actos, made by Takeda. However other reviewers mentioned that the studies offer little evidence that Avandia is actually harmful. GlaxoSmithKline scientists argued that the diabetes drug Avandia is a safe pharmaceutical option to help treat Type 2 diabetes.

Questions brought up from the advisory panel members expressed skepticism about GlaxoSmithKline’s honesty in the trail. But with a majority of the research presentations completed, members of the panel are expected to sound a greater voice of their perspective when the time comes to make a ruling. 


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