The push for statins cannot be described as evidence based until the raw data surrounding its trials is made public, a group of leading experts have claimed.
The experts, including cardiologist Dr. Aseem Malhotra and vascular surgeon Professor Sherif Sultan, said the claim that lowering cholesterol by 2mmol/L confers a benefit is based on ‘projections, not fact.’
The authors of the editorial in the Prescriber claims that ‘gross exaggeration’ of benefits and downplaying of side-effects has ‘likely led to the overmedication of millions of people across the world’.
It follows a meta-analysis in the Lancet that claimed that for every 10,000 people taking the equivalent of atorvastatin 40mg daily – lowering LDL cholesterol by about 2 mmol/L or 77 mg/dL- for five years, 500 would be spared a first ever CV event.
But the editorial in the Prescriber said: ‘The clinical studies included in the Cholesterol Treatment Trialists’ (CTT) meta-analysis upon which this claim is based did not achieve even half that level of cholesterol reduction in people whose risk of heart attack or stroke is less than 20% over the next five years. So there is no scientific evidence for the magnitude of benefit of 2mmol/L reduction in a low-risk population.’
They added: ‘The time is long past for the underlying data to be made available for independent analysis, so the public can receive the full benefit of medical science regarding statins and other cholesterol-lowering medication.
‘In conclusion, we believe that unless access to the raw clinical trial data is released, any claims about the true efficacy and harms of statins cannot be considered to be evidence based.’
Dr Malhotra said: ‘Decades of misinformation on cholesterol and the gross exaggeration of statin benefits with downplaying of side effects has likely led to the overmedication of millions of people across the world.’
Professor Iona Heath, former president of the RCGP, said: ‘The continuing controversy into the usefulness of statins risks undermining public trust in biomedical science. The controversy will only be resolved if all the existing research data is made widely available for review by genuinely independent researchers.’