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Statins: we need an independent review

BMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i4992 (Published 15 September 2016) Cite this as: BMJ 2016;354:i4992
Documents relating to a complaint about ​The BMJ ​made to COPE - updated in November 2016

Re: Statins: we need an independent review

In 1992 one of us called for a moratorium on the use of cholesterol lowering drugs in primary prevention in the BMJ1, based on a review of intervention trials at that time. Statins – which have a much greater cholesterol lowering effect than earlier agents – had only been recently introduced and long-term large-scale treatment trials had not been completed thus the conclusion that given “the current uncertainty surrounding the benefits and risks of cholesterol lowering drugs in primary prevention we suggest that their general use ... should await the results of [statin] trials”.

The trials duly appeared and it became clear that benefits existed at considerably lower thresholds of coronary heart disease risk than was the case for earlier treatments. In 2011 we published a Cochrane Review on statins for primary prevention of cardiovascular disease.2 This review concluded “caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk” based on limited reporting of potential adverse events in the statin trials, and lack of evidence of effects on quality of life. By 2013, with evidence from new trials and a re-analysis of the individual patient data from the Cholesterol Treatment Trialists 2012 report, our updated Cochrane review concluded: “The totality of evidence now supports the benefits of statins for primary prevention. The individual patient data meta-analyses now provide strong evidence to support their use in people at low risk of cardiovascular disease. Further cost-effectiveness analyses are now needed to guide widening their use to these low risk groups.” 3

In the famous words attributed (not entirely reliably) to John Maynard Keynes, “When my information changes, I alter my conclusions. What do you do, sir?” Assimilating and updating the evidence systematically is a major strength of Cochrane reviews, resulting in changes in conclusions in light of new evidence. Fiona Godlee, editor of the BMJ, has now called for the Chief Medical Officer to set up an independent inquiry into statin risks and benefits. She considers an inquiry would “need to be International and authoritative, independent of financial and academic conflicts of interest, and committed to transparency and a patient centred approach”. 4 Cochrane reviews on statins would appear to meet Godlee’s requirements but, curiously, are ignored. It may be that from her viewpoint we have got the wrong answer. It is to be hoped that the Chief Medical Officer, who supports the Cochrane Collaboration, will not overlook the value of using the resources she invests in to make decisions on health policy. Is it not time for Godlee to change her mind?

Shah Ebrahim & George Davey Smith

1. Davey Smith G, Pekkanen J. Should there be a moratorium on the use of cholesterol lowering drugs? BMJ 1992;304:431-4
2. Taylor F, Ward K, Moore THM, Burke M, Davey Smith G, Casas J-P, Ebrahim S. Statins for the primary prevention of cardiovascular disease. Cochrane Database of Systematic Reviews 2011 , Issue 1 . Art. No.: CD004816. DOI: 10.1002/14651858.CD004816.pub4
3. Taylor F, Huffman MD, Macedo AF, Moore THM, Burke M, Davey Smith G, Ward K, Ebrahim S. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD004816. doi: 10.1002/14651858.CD004816.pub5.
4. Hawkes N. BMJ editor asks chief medical officer to set up inquiry into statins risks and benefits. BMJ 2016;354:i5046.

Competing interests: No competing interests

21 September 2016
Shah B. Ebrahim
Honorary Professor of Public Health
George Davey Smith
London School of Hygiene & Tropical Medicine
LSHTM, Keppel Street, London WC1E 7HT
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