BMJ 2014;348:g3937 doi: 10.1136/bmj.g3937 (Published 11 June 2014)

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NEWS Open letter raises concerns about NICE guidance on statins Jacqui Wise London

A group of leading doctors have written an open letter to David Haslam, chairman of the National Institute for Health and Care Excellence (NICE), and to the health secretary, Jeremy Hunt, raising serious concerns about the latest draft guidance on statins.1 The letter was signed by Richard Thompson, president of the Royal College of Physicians, and Clare Gerada, former chairwoman of the Royal College of General Practitioners. The letter said, “We urge you to withdraw the current guidance on statins for people at low risk of cardiovascular disease until all the data are made available. The potential consequences of not doing so are worrying: harm to many patients over many years, and the loss of public and professional faith in NICE as an independent assessor. Public interests need always to be put before other interests, particularly [those of] Pharma.” The draft guidance from NICE, published in February, recommended lowering the threshold for treatment with statins to include people who had a 10% or higher 10 year risk of developing cardiovascular disease.2 3 Consultation on the guidance closed on 26 March, and final guidance is due to be published in July.

The letter said that the benefits of statins in a low risk population did not justify putting five million healthy people on a drug that must be taken for life. It raised six major concerns: the medicalisation of millions of healthy people; conflicting levels of adverse events; hidden data; industry bias; loss of professional confidence; and conflicts of interest. Other signatories to the letter included Simon Capewell, clinical epidemiologist at the University of Liverpool; David Haslam, chairman of the National Obesity Forum; Malcolm Kendrick, a GP; Aseem Malhotra, a London cardiologist; and David Newman, director of clinical research at Mount Sinai School of Medicine in New York. The letter raised concerns that the guidance was based almost entirely on pharmaceutical sponsored studies. It said that the data for these studies were not available for review by independent researchers but only by those who worked for the Oxford Cholesterol Treatment Trialists’ Collaboration—which itself had commercial agreements with drug companies. The letter called for other researchers, such as the Cochrane Stroke Group and the Cochrane Heart Group, to be able to assess all of the data independently. The letter also expressed serious concerns about potential conflicts of interest, as eight members of NICE’s panel of 12 For personal use only: See rights and reprints

experts for its latest guidance had direct financial ties to drug companies that manufactured statins. Some members of the guideline panel were also involved in the next generation of more expensive cholesterol lowering drugs, the letter said.

Another concern was that the levels of adverse events reported in statin trials contained worrying anomalies. For example, in the West of Scotland coronary prevention study (WOSCOPS) the cumulative incidence of myalgia was 0.06% in the statin arm and the placebo arm, whereas the METEOR study found an incidence of myalgia of 12.7% in the rosuvastatin arm and 12.1% in the placebo arm.

The letter said, “Without access to the raw data, it is difficult to understand how statin related adverse events and placebo related adverse events can mirror each other so precisely, whilst the absolute rates can vary thirtyfold (almost three thousand per cent). These data most certainly require analysis by a third party with appropriate expertise.”

Simon Capewell, professor of clinical epidemiology at the University of Liverpool, commented, “The recent statin recommendations are deeply worrying, effectively condemning all middle aged adults to lifelong medications of questionable value. They steal huge funds from a cash strapped NHS, and they steal attention from the major responsibilities that the government and food industry have to promote healthier life choices for ourselves and our children.” Malcolm Kendrick, a GP and member of the BMA’s General Practitioners Committee, said, “Mass ‘statination’ is the triumph of statistics over common sense. Treating millions at a cost of billions, all based on data we are not allowed to see, is another example of the corporatisation of medicine and will result in a public health disaster.”

David Newman, assistant professor of emergency medicine and director of clinical research at Mount Sinai School of Medicine in New York, said, “I am always embarrassed when I have to tell patients that our treatment guidelines were written by a panel filled with people who stood to gain financially from their decisions. The UK certainly appears to be no different [from] . . . the United States.” Mark Baker, director of the Centre for Clinical Practice at NICE, responded to the letter by saying, “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 Subscribe:

BMJ 2014;348:g3937 doi: 10.1136/bmj.g3937 (Published 11 June 2014)

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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.”

Baker 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 judgment. 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

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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.” 1 2

3 NICE statin letter: concerns about the latest NICE draft guidance on statins. 10 June 2014. National Institute for Health and Care Excellence. Lipid modification: cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease. NICE guideline draft for consultation. 12 February 2014. http: // Wise J. NICE recommends wider use of statins in draft guidelines. BMJ 2014;348:g1518.

Cite this as: BMJ 2014;348:g3937 © BMJ Publishing Group Ltd 2014


Open letter raises concerns about NICE guidance on statins.

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