What statins tell us about the mess in evidence based medicine

June 30th, 2014 by Ben Goldacre in evidence | 12 Comments »

Sorry to be absent, I’ve about a zillion big things shortly coming to fruition, at which point expect a deluge.

Everyone is having kittens about statins and the BMJ at the moment. Here’s what I wrote as a rabid response on the latest BMJ editorial about it, and a disco soundtrack to keep your attention focused:

www.bmj.com/content/348/bmj.g3306/rr/759401

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 in preference 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
ben.goldacre@lshtm.ac.uk

[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.

I might expand this with a colleague for a longer piece.

Also, I’m thinking of rattling out a very quick 90 page book on statins: they are the single most commonly prescribed treatment in the entirety of the developed world. If we fail on statins, then documenting those shortcomings is the roadmap to perfection, and getting 100 million patients involved in that discussion is one way to jolt two of my professions (academia and medicine) out of our complacency.

Lastly, we have an interesting new trial in the pipeline in this area, on which more shortly.


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12 Responses



  1. muscleman said,

    July 1, 2014 at 4:10 pm

    If it’s perfection we are after we could, in a very great proportion of cases, not require statins at all by improving diet, lifestyle* and taking more proper exercise (not walking the dog).

    Statins are nothing if not an unmistakeable admission of defeat by the medical profession. Defeat in terms of getting their patients to do any of the above, let alone all of them sufficiently.

    I know, I know, I’m a freak never smoking, eating well within my constraints, being a distance runner and drinking only very moderately and only occasionally (it interferes with the running, and the gout).

    We know all this, but instead we debate a better ambulance at the bottom of the cliff, or are statins a series of ledges part way down?

    *Meaning eating three regular meals with regular bedtimes (no long weekend lie-ins after late nights) and drinking only very moderately if at all. These things matter. A chaotic lifestyle, burning the candle at both ends and drinking too much are major risk factors for Type II diabetes and of course Alzheimers in later life.

  2. SimonWaters said,

    July 1, 2014 at 11:22 pm

    I don’t think statins are an admission of defeat, you won’t win all the wars. Compliance averages 60%, and mostly that is “just take these pills”, it falls further when it is “take 2.5 hours out of your week to exercise”. Statins are just one more device they can use if appropriate.

    Similar comments would apply to other preventative interventions including exercise.

    Whilst exercise is reasonably well studied, and evidence based guideline recommend it, and recommend doctors recommend it, and even recommend how to recommend it effectively, we don’t understand the full risk/benefit of saying jogging, especially where there are complications like prior heart disease. We have ample clinical experience, but that hasn’t been turned into actionable data.

    All patients remain different, I work with support groups for Graves’ disease, and amongst the first advice to the newly diagnosed is “DON’T EXERCISE TILL YOUR DOCTOR SAYS IT IS SAFE TO DO SO”.

  3. Ben Goldacre said,

    July 1, 2014 at 11:35 pm

    With the best will in the world, muscleman’s comment feels like another example of empathy failure, and the same phenomenon that I described among doctors in my post. Not everyone is like you, not everyone will agree with your priorities and choices, not everyone will even be capable of doing so. Medicine isn’t for perfect people, or people like us, it’s for everyone.

  4. David Bailey said,

    July 3, 2014 at 6:24 pm

    Ben,

    I really don’t think most patients who are put on statins are actually told that they stand a 1 in 200 chance of benefiting! I know I wasn’t, and while everything was going well, I naively interpreted my doctors enthusiasm for statins as at least a 30% reduction in risk!

    I actually wonder how many GP’s realise that 1 in 200 figure!

    Not being upfront with patients is a form of deception. Another is that awful euphemism, “muscle pains” – which suggests something you might get after a long hike! It took me 9 months after I stopped Simvastatin – taking diclofenac – to get over my muscle pains! I have also talked with people on Dr Kendrick’s site who have found their muscles never recovered!

    Is it possible that a few patients don’t get statin side effects, but report some “trivial niggles”, while others do get muscle side effects that are much more severe?

    I mean, I have talked to a number of people with similar experiences to mine, and they speak of cramps, difficulty walking, joint pains etc.

    It is actually incredibly easy to hear horror stories about statin side-effects – just ask a bunch of over-60’s!

    As you say, maybe some patients really would take statins if they were told of the 0.5% gain and the potential for nasty problems – and if they want to make that informed decision, all well and good!

  5. Ben Goldacre said,

    July 3, 2014 at 6:35 pm

    You’re mistaken. The benefit for each individual from statins depends on their preexisting cardiovascular risk. I have no idea what your cardiovascular risk is (and I don’t want to know, since I’m not your doctor) so I’ve no idea what benefit you would get, it may well be rather large.

  6. David Bailey said,

    July 3, 2014 at 8:11 pm

    Well to whom does your figure of 1 in 200 apply? I have no history of CV disease, am a life long non-smoker, aged 64, and I take tablets for hypertension. I also exercise pretty regularly.

    I don’t really want to discuss my case, I am trying to get at the general issue – no actual numbers were discussed when I was prescribed Simvastatin, and I am guessing that is typical.

    I can’t believe many people would take a pill for the rest of their lives unless it offered at least a 10% reduction in risk in their circumstances. If there really are such people, fine, but I don’t think people are given the information in such a form.

  7. David Lloyd-Jones said,

    July 6, 2014 at 12:29 pm

    Many people will find the Star Wars Disco an inadequate replacement for statins, perhaps because of the time required to put on the gold or black uniforms required by the senseitachi.

    Such people might like to consider the alternative, somewhat Canadian way of dong things, shown at taichicentral.com/all-the-tai-chi-in-the-world-cannot-prepare-you-for-some-things/

    -dlj.

  8. peajay32 said,

    July 11, 2014 at 5:28 pm

    As someone coming under pressure from my GP to take a statin for elevated total cholesterol and LDL, I would read any book you write on statins with great interest.

    I’m doubtful of the reliability of total cholesterol and LDL as indicators of CAD risk. I’m also concerned about statin side-effects as, so it seems, these can be buried by pharma-sponsored trials and I’m hearing so much anecdotal evidence of problems.

    I wonder if your epidemiology perspective might shed light on some other important questions, too. For instance, whether statins, even if they do reduce heart disease/stroke/CAD risk as is claimed, do so by another mechanism than reducing cholesterol? And could it be that average (or even higher-than-average) cholesterol can be protective overall (so that statins, by reducing cholesterol, might actually increase the risk of other life-shortening/debilitating conditions like cancer and Alzheimer’s)?

  9. bt0558 said,

    July 28, 2014 at 8:26 pm

    Sorry to be a nuisance but I am both a teacher and a potential recipient of statins (at 56). This post is about evidence based medicine but also has implications I think for evidence based teaching.

    I have wondered how evidence from RCTs and meta analyses could be useful for me as a teacher, as my students are all different.

    In Ben’s reply (5) above he explains that….

    “The benefit for each individual from statins depends on their preexisting cardiovascular risk. I have no idea what your cardiovascular risk is (and I don’t want to know, since I’m not your doctor) so I’ve no idea what benefit you would get, it may well be rather large.”

    The implication seems to be that it is the individual that will determine whether statins are appropriate so why bother with the large scale trials etc. The large scale trials surely cannot tell us about the individual.

    I am thinking about evidenced based teaching and the issue appears to be similar. I can find out that maybe 70% of people benefit from using mindmaps, but I need to know whether mindmaps are effective for each of the people I teach. This is why Ben’s “you are mistaken” concerns me.

    Will RCTs etc also tell me which individuals will benefit or do I apply to everyone knowing that for X% it wont work, but only experience will tell me which 30%.

    I hope that makes sense.

    Does anyone have recommended reading that may illuminate for me?

  10. bt0558 said,

    July 28, 2014 at 9:50 pm

    Just found this paper by Ben…

    media.education.gov.uk/assets/files/pdf/b/ben%20goldacre%20paper.pdf

    Seems to be just what I need. Will read and inwardly digest.

  11. Joan said,

    August 10, 2014 at 9:22 am

    I found this very helpful and am sharing with friends, many if whose cardiologists want to put them on statins, even though they’re low risk according to guidelines. I’m switching cardiologists as I’m having the same problem with my previously wonderful cardiologist of 10 years. I’m low risk with a calcium score of 1 (up from 0 after 5 years) and my lipids are all within normal limits, though my HDL could be higher and more bubbly. But my cardiologist, a healthy normal weight woman who gets regular aerobic exercise, has joined her colleagues and is now on statins – the miracle fountain of youth pill. She wants to put me on statins if my LDL gets too high, even if nothing else changes. This is not good medical practice to me and the ongoing conflict has greatly reduced my trust. Unfortunately, I don’t think my experience is atypical from talking with my friends.

  12. gers said,

    September 11, 2014 at 11:53 pm

    so, when do we learn where the figure of 1 in 200 comes from? on June 30th Ben says 1/200. On July 3rd he says ” it could be rather large” . Obviously, the whole piece depends upon this single figure of risk. what is it, on average?

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