Prof Sir Rory Collins

Benefits of statins outweigh risks, says medicines regulator

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MHRA says evidence from clinical trials shows statins can save lives by reducing risk of heart attacks and need for surgery
Statin pills
Statin pills. 

Millions of people prescribed cholesterol-reducing statins should continue to take them because the benefits outweigh the risks, Britain’s medicines regulator said on Friday. The Medicines and Healthcare products Regulatory Agency (MHRA)issued a safety update following a row over the frequency of side effects from the drugs. It said evidence from large clinical trials showed statins could save lives by reducing the risk of heart attacks, strokes and the need for heart surgery.

Its advice to health professionals said at least 450 deaths from heart attacks, stroke or vascular failure would be prevented for every 10,000 patients treated, if patients with a 20% risk or more of suffering such a cardiovascular event over a 10-year period took statins for at least five years.

The update came after the British Medical Journal(BMJ) commissioned an independent panel to report on how claims that 18-20% of people on statins suffered adverse events were published in the journal last year .

The verdict is expected by the end of July. The authors of two articles using the figure, John Abramson, from Harvard medical school, and Aseem Malhotra, a UK cardiologist, have withdrawn statements on the frequency of side effects following a charge from Prof Sir Rory Collins of Oxford University that the information was inaccurate and could endanger lives.

Collins, a leading advocate of statins, has argued that both articles should be withdrawn completely, saying they had caused uncertainty in patients. He suggested they could lead to far more harm than the scare over the MMR vaccine caused by the now discredited Andrew Wakefield.

Statins are currently being taken in Britain by about 7 million people who have at least a 20% risk of a heart attack or stroke in the next 10 years. The National Institute for Health and Care Excellence (Nice) recommended in February that statins should be given to people at only 10% risk – a move that could dramatically increase the number of people taking them.

Professor who sparked statins row says government should intervene

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Prof Sir Rory Collins says he has little confidence in British Medical Journal’s inquiry into papers on side-effects of drugs
Prof Sir Rory Collins
Prof Sir Rory Collins said fears over statins could cause ‘very large numbers of unnecessary deaths from heart attacks and strokes’. 

The Oxford professor who triggered a public row over statins says the Department of Health and other authorities should intervene to ensure the public gets accurate information on the risks and benefits of the potentially life-saving drugs.

Prof Sir Rory Collins said he had little confidence in an inquiry convened by the British Medical Journal to decide whether two papers it published last year that made an error on the extent of side-effects should be completely withdrawn.

The papers published by the BMJ were by John Abramson, a clinician working at Harvard medical school, and Aseem Malhotra, a cardiologist in the UK. Abramson said statins in low-risk patients did not reduce mortality. Both authors said that in the low-risk group the side-effects meant they sometimes did more harm than good.

The authors have retracted statements on the frequency of side-effects but Collins said that as long as the papers were in circulation, they would wrongly undermine confidence in the drugs, and he did not believe the inquiry was truly independent. He said: “I don’t think it is appropriate for the British Medical Journal to investigate itself,” and called on the General Medical Council, the Academy of Medical Sciences or the Department of Health to investigate.

He said when the BMJ “gets things wrong, it doesn’t correct them properly; when it’s shown it gets things wrong, it doesn’t make that clear – for example blaming the peer reviewers when it wasn’t the peer reviewers’ fault – and they shouldn’t be in a position where they are investigating themselves. That wouldn’t be happening in any other sphere.”

Cholesterol-lowering statins are life-savers, helping prevent heart attacks and strokes in people who have already had one and so are at high risk of another. But the battle now raging is over the use of the drugs in healthy people at low risk.

Draft guidance from the National Institute for Health and Care Excellence (Nice) has recommended that everybody with a risk as low as 10% over 10 years (rather than 20% as now) should be eligible for statins from their GP. About 7 million middle-aged people are now taking a daily statin and the regulator’s proposed guidance could extend that to 5 million more.