PART 2: Should rosuvastatin (Crestor®) be withdrawn from the market?
FDA's approval of rosuvastatin was largely based on a flawed trial prompting experts to call for the drug to be banned.
NOTE TO READERS: In early January, Sidney Wolfe, physician and co-founder of Public Citizen’s Health Research Group tragically passed away. Prior to his death, I had the honour of speaking with Dr Wolfe about his efforts to have rosuvastatin withdrawn from the market.
Crestor® (generic name rosuvastatin) was initially approved in 2003 by the US Food and Drug Administration (FDA) for the treatment of high cholesterol.
But the manufacturer AstraZeneca, had yet to prove that its drug could do more than just lower cholesterol. It also had to show that rosuvastatin could reduce heart attacks and strokes like its competitors.
Rosuvastatin was put through its paces in a series of randomised controlled trials - CORONA, GISSI-HF and AURORA - but all three failed to demonstrate a benefit in clinical outcomes for various patient populations.
So all hopes were on the JUPITER trial -- could rosuvastatin reduce heart attacks in apparently healthy people with normal cholesterol levels and no evidence of prior heart disease (known as primary prevention)?
Trial participants were also selected for having raised levels of C-Reactive Protein (CRP), believed to be a marker of inflammation.
The trial would turn out to be one of the most controversial studies of its time.