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10 June 2014

NICE responds to criticisms of its draft guidance on statins

Responding to an open letter to NICE Chairman Professor David Haslam from a group of doctors about NICE's draft guidance on statins, Professor Mark Baker, Director of the Centre for Clinical Practice at NICE, said: "Cardiovascular disease maims and kills people through coronary heart disease, peripheral arterial disease and stroke. Together, these kill 1 in 3 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.

"The draft guideline does not propose that statins should be used instead of the lifestyle adjustments that people at risk of cardiovascular disease need to make - such as stopping smoking, being more active, drinking less alcohol, eating more healthily and losing weight. It encourages GPs to fully explore with their patients the ways in which people can reduce their risk of cardiovascular disease, presenting all the options promoted by the draft guidance, including lifestyle changes, blood pressure control, avoidance of diabetes and cholesterol (lipid) lowering, and to allow patients to make their own decisions.

"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 over ten years. 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.

"NICE guidance is developed by independent expert committees. They review all of the available evidence and their conclusions are subject to genuine public consultation. The committees are made up of clinicians, patients and others with the skills necessary to help interpret sometimes complex data. None of them have put their names to the recommendations to make money for themselves, as the American doctor, who co-signed the letter alleges.

"It is impossible to put together credible clinical practice guidance without drawing on the knowledge of those who understand and work with the drugs and other treatments involved.

"The approach we take to managing conflicts of interest has been developed over the 15 years that NICE has been developing guidance for the NHS. Our approach is transparent, rigorous and sensible. It plays its part in what is generally acknowledged is the gold standard for producing clinical practice guidance.

"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 have looked at the same evidence and reached similar conclusions about the prescription of statins."

ENDS

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Notes to Editors

About NICE's draft clinical guideline on lipid modification

The draft update of the NICE clinical guideline on lipid modification is available from the NICE website.

About NICE

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Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).

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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

Professor Mark Baker, Director of the Centre for Clinical Practice at NICE