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Fact check

Is it true: GSK Avandia CV risk concealment (1999–2010)?

Confirmed5% confidence

Yes — this is confirmed.

Senate Finance Committee (February 2010) found GSK had internal cardiovascular risk data on Avandia from 1999 onward, including an internal 2006 meta-analysis that preceded Nissen's NEJM publication by a year, and did not disclose it to the FDA. Nissen NEJM 2007: 43% increased MI risk (42-trial meta-analysis). FDA restricted Avandia in 2010. European Medicines Agency suspended it in 2010. DOJ $3 billion settlement (2012, then-largest healthcare fraud settlement in US history) covered Avandia safety data concealment and unlawful promotion.

The claim

GlaxoSmithKline's diabetes drug Avandia (rosiglitazone) was approved by the FDA in 1999. A 2007 meta-analysis by cardiologist Steven Nissen, published in the New England Journal of Medicine, found tha

Key evidence

Nissen NEJM 2007: 43% elevated myocardial infarction risk

FDA reversed Avandia restrictions in 2013 after RECORD re-analysis

Read the full evidence file

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