Adverse effects of statins

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3306 (Published 15 May 2014) Cite this as: BMJ 2014;348:g3306

Statins are a mess: we need better data, and shared decision making

I have two observations to make on the statin wars.

Firstly: if there is any uncertainty at all about the risks and benefits of statins – and there is - then we have failed to competently implement the most basic principles of evidence based medicine. Statins are the single most commonly prescribed class of treatment in the developed world, taken by tens if not hundreds of millions of patients every day. That would be more than enough clinical experience to resolve any research questions, if we were competently identifying all outstanding uncertainties, and conducting well-designed trials to answer those questions in routine clinical care [1]. We need better data; better dissemination of that data; and better communication of that data, in ways that help people make decisions which reflect their wishes. Statins should be the crowning glory of evidence based medicine, our perfection incarnate: instead, they are a mess.

Secondly: while disputes over individual numbers are important, the leading protagonists in the statin wars seem, above all, to be suffering under a grand delusion that all patients think like they do. On the one hand, we have clinicians and researchers insisting that no sane patient would refuse a safe simple treatment that reduces their chances of a heart attack by one in 200; on the other, we have clinicians and researchers insisting that one in 200 is a laughable and trivial benefit, which no sensible patient could ever care about.

In reality, all patients are different, and we all – as doctors or as patients - weigh up different factors differently. Some want longevity at any cost; some think taking a pill every day is an affront to their independence. Some think aching muscles are a trivial niggle; some think that side effects - even when mild, well-documented, and carefully discussed - are proof that their doctor is a reckless idiot.

When we offer statins, or any preventive treatment, we are practicing a new kind of medicine, very different to the doctor treating a head injury in A&E. We are less like doctors, and more like a life insurance sales team: offering occasional benefits, many years from now, in exchange for small ongoing costs. Patients differ in what they want to pay now, in side effects or inconvenience, and how much they care about abstract future benefits. Crucially, the benefits and disadvantages are so closely balanced that these individual differences really matter.

Because of that, this new kind of medicine needs perfect information. We need clean, clear data showing the risks and benefits of preventive treatments, on real world outcomes, beyond any reasonable doubt, at every level of risk, and for as many subgroups as possible. We need shared decision making products that are universally available, carefully validated, and seamlessly integrated into routine clinical care, to help all patients make their own truly informed decisions. Lastly, we need to recognise that different patients have different priorities: different to each other and, sometimes, very different to our own.

Ben Goldacre
Research Fellow in Epidemiology
London School of Hygiene and Tropical Medicine
[email protected]

[1] Staa T-P, Goldacre B, Gulliford M, et al. Pragmatic randomised trials using routine electronic health records: putting them to the test. BMJ. 2012;344(feb07 1):e55-e55. doi:10.1136/bmj.e55.

Competing interests: I have a Wellcome Clinical Research Training Fellowship and receive income from talking and writing for public and professional audiences about problems in science and medicine.

30 June 2014
Ben M Goldacre
Research Fellow in Epidemiology
London School of Hygiene and Tropical Medicine
Keppel St, Bloomsbury, London WC1E 7HT
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