Top doctors criticise NICE proposals to significantly expand statin use
A group of leading doctors have criticised plans to advise millions more people to take cholesterol-reducing statins.
The drugs are currently offered to as many as seven million people in the UK who have a 20% risk of developing cardiovascular disease within 10 years.
Draft guidance from the National Institute for Health and Care Excellence (NICE) has called for the NHS to widen this to cover people with just a 10% risk.
“The recent statin recommendations are deeply worrying”
But a number of prominent clinicians have written a letter to health secretary Jeremy Hunt to express their concerns.
The signatories, including the president of the Royal College of Physicians and a former chair of the Royal College of General Practitioners, claim that the latest guidance is based almost entirely on studies funded by the pharmaceutical industry.
The group cite findings from non-industry sponsored studies which include an increased risk of developing diabetes in middle aged women taking statins.
Other side effects include fatigue, psychiatric symptoms and erectile dysfunction, the clinicians warn.
They also claim that the “medicalisation of millions of healthy individuals” is unjustified.
One of the signatories is Professor Simon Capewell, professor of clinical epidemiology at the University of Liverpool. He said: “Two decades of research has confirmed the obvious: doctors receiving drug industry funding produce recommendations favouring the industry.
“NICE urgently need to develop a better mechanism for controlling these conflicts of interests,” he said. “The recent statin recommendations are deeply worrying, effectively condemning all middle aged adults to lifelong medications of questionable value.”
Another signatory London cardiologist Dr Aseem Malhotra said: “Although there is good evidence that the benefits of statins outweigh the potential harms in those with established heart disease, this is clearly not the case for healthy people.
“For example a doctor wouldn’t give chemotherapy to a patient who didn’t have cancer or prescribe insulin to someone without diabetes.
“When you add up doctors’ appointments, unnecessary suffering for those who experience side effects that interfere with the quality of life, the illusion of protection of taking a drug that won’t reduce the risk of death in healthy people - and the increasing burden of chronic disease which is predominantly lifestyle-related - prescribing statins to millions of healthy people would increase costs to the NHS, not reduce it.”
“Our proposals are intended to prevent many lives being destroyed”
But Professor Mark Baker, director of the centre for clinical practice at NICE, insisted that the draft guidance does not propose that statins should be used instead of lifestyle adjustments by people at risk of cardiovascular disease.
He said: “Cardiovascular disease 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.
“We have consulted on these proposals and the results of this consultation are currently being reviewed prior to publication of our final recommendations next month. Our proposals are also being independently peer reviewed to ensure they are reliable and evidence-based.”
Professor Baker stressed that NICE guidance is developed by independent expert committees and none of them support the recommendations to make money for themselves.
He added: “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.”
The full list of signatories:
- Sir Richard Thompson, president of the Royal College of Physicians
- Professor Clare Gerada, former chairman of the Royal College of General Practitioners
- Professor David Haslam, GP and chairman of the National Obesity Forum
- Dr J S Bamrah, consultant psychiatrist and medical director of Manchester Mental Health and Social Care Trust
- Dr Malcolm Kendrick, GP and member of the British Medical Association’s General Practitioners sub-committee
- Dr Aseem Malhotra, London Cardiologist
- Dr Simon Poole, GP
- David Newman, assistant professor of emergency medicine and director of clinical research, Mount Sinai School of Medicine, New York
- Professor Simon Capewell, professor of clinical epidemiology, University of Liverpool