Editor's Choice

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

Response to the rapid response from Shah Ebrahim and George Davey Smith

I congratulate Shah Ebrahim and George Davey Smith for changing their minds in response to new information. I look forward to having the opportunity of doing the same when the anonymised individual patient data (IPD) and clinical study reports (CSRs) from the statin trials have been made available for independent review. This is what others have called for[1] and what I have asked the Chief Medical Officer to make happen.[2]

I agree that your Cochrane review was independent of industry and of the trialists, but you didn’t have access to these raw data. Nor, so far as I am aware, have you sought access or called for the data to be made available. You relied on the CTT collaborators analysis, which itself had only half of the IPD from the trials: the half relating to benefits of statins, not their harms. Via Twitter you have said that the Cochrane review of statins is no different in this to many other systematic reviews: why pick on statins?[3] Because they are one of the most widely prescribed class of drugs in the western world; because there is new guidance in the US and the UK proposing that their use should be extended to large numbers of healthy people;[4] [5] because this new guidance has created international controversy about the true balance of benefits and harms in people at low risk of heart disease; because this controversy has added to existing widespread concerns about the side effects of statins and is fuelling public confusion, including among people at higher risk of heart disease and stroke who stand to benefit most from taking statins;[6] and because, in my experience, when the IPD, CSRs and other regulatory documents are thoroughly scrutinised by fresh expert eyes, new and useful information emerges that can better guide patients and doctors in their decisions, as well as informing future research.[7]

For the moment I acknowledge that I am instinctively sceptical about the wisdom of medicating large numbers of healthy people, especially when alternatives to drug treatment exist.[8] I can think of no better outcome of this exchange than that you will put yourselves forward as one of the groups willing to review the anonymised IPD and other materials once these are made available.

1. Krumholz H. Statins evidence: when answers also raise questions. BMJ 2016;354:i4963. http://www.bmj.com/content/354/bmj.i4963

2. Hawkes N. BMJ editor asks chief medical officer to set up inquiry into statin risks and benefits. BMJ 2016;354:i5046. http://www.bmj.com/content/354/bmj.i5046

3. @fgodlee @cochranecollab nor do huge number of other reviews you with much less data you don't quibble with (and publish sometimes)
Original Tweet: https://twitter.com/mendel_random/status/776785709441187840

4. National Institute for Health and Care Excellence. Cardiovascular disease: risk assessment and reduction, including lipid modification. Clinical guideline [CG181]. NICE guidance 2014. https://www.nice.org.uk/guidance/cg181

5. Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014;63(25_PA):2889-2934. doi:10.1016/j.jacc.2013.11.002. http://content.onlinejacc.org/article.aspx?articleid=1879710

6. Matthews A, Herrett E, Gasparrini A, Van Staa T, Goldacre B, Smeeth L, et al. Impact of statin related media coverage on use of statins: interrupted time series analysis with UK primary care data. BMJ 2016;353:i3283. http://www.bmj.com/content/353/bmj.i3283

7. Jefferson T, Jones M, Doshi P, Spencer EA, Onakpoya I, Heneghan CJ. Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments. BMJ 2014;348:g2545. http://www.bmj.com/content/348/bmj.g2545

8. Tong TYN, Wareham NJ, Khaw K-T, Imamura F, ForouhiNG. Prospective association of the Mediterranean diet with cardiovascular disease incidence and mortality and its population impact in a non-Mediterranean population: the EPIC-Norfolk study. BMC Medicine 2016;14:135. DOI: 10.1186/s12916-016-0677-4. http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0677-4

Competing interests: I am the Editor in Chief of The BMJ and responsible for all that it contains. The BMJ campaigns for access to the data from clinical trials and against overdiagnosis and overtreatment, through its Open Data and Too Much Medicine campaigns.

30 September 2016
Fiona Godlee
Editor in Chief
The BMJ, London WC1H 9JR