July 7th, 2014

Statins Are a Mess: We Need Better Data, and Shared Decision Making

The following open letter was originally published on The British Medical Journal‘s editorial page regarding the adverse effects of statins for patients with low risk of cardiovascular disease. It was written in response to an analysis by Abramson et al, and more information on the subject can be found here.

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 (see related article here). 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.

4 Responses to “Statins Are a Mess: We Need Better Data, and Shared Decision Making”

  1. Floyd Casaday, MD says:

    Bravo! Couldn’t agree more.

  2. Donald M Lloyd-Jones, MD, ScM says:

    I agree wholeheartedly with the sentiment that shared decision-making, bolstered by the best available evidence and, crucially, considering the patient’s individual preferences, must be the cornerstone of our approach to primary prevention (especially primary prevention!). In fact, this is why we recommended exactly that approach in the recent ACC/AHA prevention guidelines (finally published in hard copy July 1 in Circulation and JACC). And I note that the JBS prevention guidelines also firmly recommend this.

    However, I dispute the author’s implication that statins would reduce the risk of a heart attack by 1 in 200 for every patient. For the same reasons that the author argues that we should remember that every patient is different with regard to their preferences, we should remember that patients also differ with regard to their expected benefit from a statin. This is why risk-based approaches are important, since risk drives the expected benefit — the higher the patient’s risk, the greater the potential benefit in absolute risk reduction from a statin. This has been shown beautifully by the Cholesterol Treatment Trialists. The low 0.5% absolute risk reduction posited by the author would accrue to a patient with a predicted 10-year risk of about 2%, far below the threshold recommended by any of the current guidelines. Patients at higher risks would expect greater absolute benefit. It is only by lining up absolute risk with expected absolute benefit, and potential absolute risks of harms from statins (as we did in the ACC/AHA full cholesterol treatment report), that we can have the kind of shared decision-making with our patients that we desire. We will never have perfect information to satisfy the need in every clinical scenario. But we do already have the data needed to provide for well-informed, quantitative discussions with our patients that can allow them to live comfortably with their decision to take a statin (or not).

  3. Maarten Vasbinder, MD says:

    Agree 100%. As long evidence based medicine has turned into evidence biased medicine, we have to be extremely careful in prescribing all kinds of so called “must” medicines (m&m). M&M works many times better and is for many people must tastier.

  4. Totally agree with Dr Goldacre.
    I would add that in all my longue medical career I cannot find a similar example of shameless, aggressive, unscrupulous, interminable
    promotion campaign as the pharmaceutical companies had waged for statins during decades. And no matter how convincing the statistics were, I know that many of our colleagues prescribed them because everyone else did.
    Maybe us, physicians, should be less accommodating with the advertising of medicines, and use more our critical faculties and our own experience, even if that means contradicting the actual trend or loss of some appealing benefits.