Avandia caused 83,000 extra heart attacks — GSK hid the data and paid $3B

Avandia (rosiglitazone) was a diabetes drug launched by GlaxoSmithKline in 1999. It became a blockbuster with peak annual sales of $2.5 billion by 2006. In May 2007, a landmark meta-analysis by Dr Steven Nissen found that Avandia increased the risk of heart attack by approximately 40%. GSK's own internal analysis from 2006 had already found a 1.31-fold risk increase but was never disclosed to regulators or the public.

An FDA scientist estimated that Avandia caused approximately 83,000 excess heart attacks between 1999 and 2007. Compared to the alternative drug pioglitazone, rosiglitazone was associated with 170 extra myocardial infarctions and 649 extra cases of heart failure per 100,000 patients, as well as a 27% higher stroke risk in patients over 65. The drug was suspended across Europe in 2010 and heavily restricted in the US.

GSK faced over 13,000 lawsuits. In 2010, the company settled approximately 10,000 cases for $460 million. In July 2012, GSK agreed to pay $3 billion to the US Department of Justice — the largest health care fraud settlement in US history at the time — for concealing Avandia's cardiovascular risks between 2001 and 2007. The drug's reputation never recovered; sales collapsed from $2.5 billion to under $10 million within five years.

GSK concealed its own 2006 analysis showing a 1.31-fold heart risk, paying $3B to settle fraud charges.

GSK knew about the cardiovascular risk from its own 2006 analysis but did not disclose it — an internal risk ratio of 1.31 was kept from regulators and the public for over a year.

Avandia was a $2.5B blockbuster and GSK had no replacement — the financial incentive to suppress unfavourable data was strong enough to override patient safety.

GSK's concealment was systematic — the $3B DOJ settlement, the largest health care fraud penalty at the time, was for deliberately hiding safety data rather than for an error in the drug itself.

A drug that causes 83,000 heart attacks while its maker hides the data is not a blockbuster with a safety question — it is a fraud, and the $3 billion fine was the cost of keeping the sales going.