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A group of doctors, including the head of one royal college and the former head of another, is calling for a rethink on an NHS proposal that people at low risk of heart disease should be prescribed statins.
Sir Richard Thompson, president of the Royal College of Physicians, and Clare Gerada, a past chair of the Royal College of GPs, are two of the eight signatories of a letter to the National Institute for Health and Care Excellence (Nice) and the health secretary, Jeremy Hunt.
The signatories are concerned that up to five million healthy individuals will be "medicalised". The Nice guidelines, which are still in draft form, propose that anyone with a 10% or greater risk of developing cardiovascular disease in the next 10 years should be eligible for treatment with the cholesterol-busting drugs.
But the appeal was firmly rejected by Nice. "Cardiovascular disease [CVD] maims and kills people through coronary heart disease, peripheral arterial disease and stroke. Together, these kill one in three of us. Our proposals are intended to prevent many lives being destroyed," said Prof Mark Baker, director of the centre for clinical practice at Nice.
The eight doctors say they do not believe the benefits of statins outweigh the side-effects. The doctors point out that all the trial data comes from pharmaceutical company trials, which have not been put in the public domain. "The overdependence on industry data raises concerns about possible biases. Extensive evidence shows that industry-funded trials systematically produce more favourable outcomes than non-industry sponsored ones," they write.
Nice says the draft guideline does not propose that GPs automatically prescribe pills. Baker says doctors and patients should explore the options for stopping smoking, losing weight, eating more healthily, drinking less alcohol and becoming more active.
"The independent committee of experts found that if a patient and their doctor measure the risk and decide statins are the right choice, the evidence clearly shows there is no credible argument against their safety and clinical effectiveness for use in people with a 10% risk of CVD over 10 years," Baker said.
"Because the price of statins has fallen, it is also cost-effective to use them to reduce the risk of cardiovascular disease at a lower threshold than Nice has previously recommended.
"This guidance does not medicalise millions of healthy people. On the contrary, it will help prevent many from becoming ill and dying prematurely. We recognise that strong views are held by some on both sides of the argument about the best way to use statins, but our job is to reach a balanced judgement. Concerns about hidden data and the bias that the pharmaceutical industry may or may not have are important issues and need to be resolved. Nice is part of the effort to do that but just as the signatories to the letter will have done in their professional careers, we need to act in the best interests of patients on the basis of what we know now.
"Finally, it's worth noting that other countries, most notably the US, have looked at the same evidence and reached similar conclusions about the prescription of statins."
The other signatories of the letter are Prof Simon Capewell, clinical epidemiologist at the University of Liverpool, Prof David Haslam, chair of the National Obesity Forum, GP Dr Malcolm Kendrick, cardiologist Dr Aseem Malhotra, Dr JS Bamrah, medical director of Manchester Mental Health and Social Care Trust, and Prof David Newham, director of clinical research at the Mount Sinai School of Medicine in New York.
They say they are also concerned that GPs have lost confidence in the drugs for low-risk patients, citing a survey by Pulse magazine and a resolution of the general practitioners committee of the British Medical Association, which called on Nice to refrain from recommending statins for this group "unless this is supported by evidence derived from complete public disclosure of all clinical trials' data".
The letter is published as the British Medical Journal convenes an inquiry into the publication of two papers – one of them written by Malhotra – on statins, which made claims for the scale of side-effects which were later publicly retracted.
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