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BMJ withdraws statements on side effects of statins



The British Medical Journal has become embroiled in a row with a leading academic over the retraction of two studies which mistakenly concluded that statin side effects occur in 18%-20% of patients.

Professor Rory Collins, professor of medicine and epidemiology at Oxford, has called for the articles – which re-analysed data from a collaboration led by him – to be retracted after they both cited data from a separate, uncontrolled, observational study.

The authors of the two studies – Dr John Abrahamson from Harvard University and UK-based cardiologist Dr Aseem Malhotra – have agreed to withdraw their statements that statins side effects occur in 18%-20% of cases, which was based on the incorrect, unobserved study.

However, they and the BMJ stand by their main conclusion: that there is no mortality benefit associated with treatment of people with a less than 20% risk of developing cardiovascular disease over the next ten years.

Professor Collins’ study argued that patients a much lower risk than this could benefit, and NICE sided with him in February by recommending in February that statins should be given to patients with a 10% risk.

Professor Collins said: ‘If people at elevated risk stop taking their statins – or don’t start taking their statins – then they will have unnecessary heart attacks and strokes. There will be unnecessary deaths from vascular causes. This is a serious disservice to medicine.’

BMJ editor-in-chief Fiona Godlee has asked an independent panel – led by former RCGP president Dr Iona Heath – to assess whether the articles should retracted in full. 

In an editorial, she said: ‘The BMJ will continue to debate the important questions raised in both of these articles; whether the use of statins should be extended to a vastly wider population of people at low risk of cardiovascular disease, and the role of saturated fat in heart disease.’

This comes after a large meta-analysis of randomised controlled trials concluded there was no increase in the rate of commonly reported side effects of statins when compared with placebo.

GP leaders have previously warned that the proposal could bring a risk of over-treating older patients, as well as diverting too much of their time onto healthier patients at the cost of managing needier patients.

Editorial: BMJ 2014;348:g3306