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GPs go forth

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

Readers' comments (8)

  • Vinci Ho

    There is always a situation of two schools- pro-statin and anti-statin
    I only go with common sense: no drug is not without side effect, question is how serious are the side effects , and can individual patient tolerate?
    End of the day , benefit against side effects means differently to different individuals . Trying to play parenting is not necessarily to the best interests of our patients and they could easily stop taking the drug anyway.

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  • Vinci Ho

    Correction : drug is without side effect.....

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  • The 'independent panel' needs to show no vested interest at all. Both Fiona and Iona are involved in a campaign against 'overdiagnosis'. The next conference is in September at Oxford. Fiona introduces Iona at meetings as 'my friend' is not necessary to compromise this investigation in this way. Neither Iona Heath nor Fiona Godlee are able to demonstrate independance .

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  • Prof Colin's is hugely conflicted.To date he refuses to share data of his research.How can he question other studies without disclosing his data?He need telling how much his research was funded by the Pharma!

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  • Come on Collins show us the data if there's nothing to hide.

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  • I agree with the Above comments. Professor Rory Collins said in the interview with the BBC when asked by the interviewer about his funding. He claimed that Big Pharma just gave him 'a donation'. A big business concern gives 'a donation' without expecting anything back.!!!!!! I don't think so .

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  • NICE in an earlier review of statins identified the problem of 'off label run in' this is done in trials to ensure compliance usually about5 to 10% drop out .In woscops the figure was 66% 4s 45% heart protection 60% with a further 18% of the trial group failing to comply but not the placebo group .In a recent study at kings by a colleague compliance with statins was to the order of 25% and in Hippesly cox's paper unwanted effects of statins 50% of statin users suffered from depression .these are wildley excessive figures and if you bother to check the ck about 10% will have elevation .No serious side effects! This is cloud cuckoo land

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  • When statins have been shown to cause pancreatitis in some patients, what alternative drug treatment is available when a low fat diet seems to have no effect whatsoever?

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