File this under “What a difference patient-level data can make.”
In 2007, controversy flared over the safety of a widely used diabetes pill called Avandia after an analysis found increased heart attack risks. The results led to congressional hearings about regulatory oversight, the Food and Drug Administration required more demanding studies for similar drugs, and GlaxoSmithKline (GSK) was accused of allegedly manipulating data in a concurrent safety trial of its own.
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