GlaxoSmithKline posted a 30-page white paper online on February 23 in reaction to a report from the US Senate Finance Committee.
While the Senate report stated that the company knew that its diabetes drug Avandia could increase a patient's chance of a heart attack, the drugmaker countered that is not "accurate, balanced, or complete view" and denied that it had inappropriately marketed the drug. It also added two posts (here and here) on its More than Medicine blog to respond to questions from various stakeholders.
The Food and Drug Administration, which is saying that patients should not stop using Avandia, has scheduled an advisory panel meeting in July.
The agency must walk a delicate tightrope. It sees diabetes growing at epidemic rates and is acutely aware of the many comorbidities associated with diabetes. Two-thirds of all patients with diabetes are not adequately controlling the disease, and diabetes is not just a health care issue but an economic issue as well.
Given this set of circumstances the FDA must make a decision delicately balancing a drug's potential benefits with what can an unknown set of risk factors.