Goldacre, Ben

Smeeth, Liam

B. Goldacre

L. Smeeth

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Mass treatment with statins

LSHTM Research Online

Goldacre, B; Smeeth, L (2014) Mass treatment with statins. BMJ(Clinical research ed), 349. g4745. ISSN 0959-8138 DOI: 10.1136/bmj.g4745Downloaded from: http://researchonline.lshtm.ac.uk/1848498/DOI: 10.1136/bmj.g4745Usage GuidelinesPlease refer to usage guidelines at http://researchonline.lshtm.ac.uk/policies.html or alterna-tively contact researchonline@lshtm.ac.uk.Available under license: Creative Commons Attribution Non-commercialhttp://creativecommons.org/licenses/by-nc/2.5/Mass treatment with statinsTrue informed choice will require wholesale changes to the way we gather and communicateevidenceBen Goldacre research fellow in epidemiology, Liam Smeeth professor of clinical epidemiologyLondon School of Hygiene and Tropical Medicine, London WC1E 7HT, UKIn broad terms, statins are cheap and more likely to do goodthan harm. But broad terms may no longer be sufficient. TheUK National Institute for Health and Care Excellence (NICE)now recommends offering a statin to anyone with more than a10% 10 year risk of a cardiovascular event, estimated to be 25%of the population aged 30-85 years.1Whenwe offer a preventivedrug to such large numbers of healthy people, we are a longway from the doctor treating a sick patient. In some respects,we are less like doctors and more like a life insurance salesteam: offering occasional, possibly life changing, benefits, manyyears from now, in exchange for small ongoing inconvenienceand cost. This represents a new kind of medicine, and deliveringinformed choice that reflects differing patient preferences willrequire wholesale structural improvements in how we gatherand communicate research evidence.The current data on statins have many avoidable shortcomings.Important questions on comparative efficacy, and efficacy indifferent risk strata, have never been adequately answered.2 3We still do not know the difference, for example, in mortalitybenefits and side effects between high and low dose atorvastatintreatment in the new primary prevention population at 10% risk.Perhaps more importantly, we lack reliable information fromrandomised trials on common symptomatic side effects ofstatins.4-6This persisting uncertainty about the precise risks and benefitsof statins is a serious barrier to informed patient choice; aftertwo decades of widespread statin prescription, it also shows thatwe have so far failed to implement the core principles ofevidence based medicine. Cardiovascular disease is the mostcommon cause of death in the United Kingdom, the outcomesare comparatively straightforward to ascertain, and statins arethe most commonly prescribed class of drug in the NHS. Thatshould be enough motivation and clinical experience to resolveany uncertainty.Gathering evidence of benefit from modestly effectivepreventive treatments in low risk participants poses specificchallenges for researchers. It requires large numbers ofparticipants and long follow-up times, which both drive up costs.Here, however, the NHS offers a unique opportunity forinnovation.7 When comparing widely used treatments that areknown to be safe and effective, it should be trivial to embedrandomised trials unobtrusively into routine clinical activity,using cheap, routinely collected electronic health record datafor outcomes. A comparison of high and lower intensity statintreatment in a low risk population would be one such example.We recently attempted a similar trial but faced numerousexpensive regulatory barriers that were disproportionate to therisks.8There are also important challenges around communicatingevidence effectively. Here, even NICE falls short. Althoughdoctors are told they must give clear information to patients onthe benefits of treatment, at high and low intensity, at each levelof risk, this information cannot be found in the 302 pageguideline. Yet such data are vital, because different people givediffering weights to different aspects of risk and benefit: somewant longevity at any cost, for example, while others regardeven mild side effects as an affront.The best solution is likely to involve decision makingtools9 10—numerical printouts that are tailored to patients’ ownrisks—if these can be integrated seamlessly into electronic healthrecord systems, validated, and made into attractive and helpfulproducts.11 Sadly, such tools do not receive funding or attentionon the same scale as even generic drugs. Consequently, theiruse is patchy and often requires laborious manual data entry. IfNICE recommended the information as clearly as it recommendsthe pill, this might help create a demand, a market, and fundingwithin the NHS.Currently, however, NICE seems ambiguous about its corerecommendations. The press release and promotional activityaround the guideline emphasised lifestyle changes and the needfor patients to receive clear information on the benefits oftreatment.12 However, the guideline itself has a differentemphasis: of eight “key priority recommendations” forimplementation, four focus on which tool best identifies patientsfor treatment, and four focus on atorvastatin. None mentionslifestyle or communicating evidence on treatment options. NICEsummarises large numbers of randomised trials on interventionsthat target individuals to improve diet and encourage exercise,most with negative results, yet it still recommends theseinterventions. Lifestyle change is likely to deliver large healthben.goldacre@lshtm.ac.ukFor personal use only: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribeBMJ 2014;349:g4745 doi: 10.1136/bmj.g4745 (Published 23 July 2014) Page 1 of 2EditorialsEDITORIALSbenefits well beyond lipid lowering, but there is no goodevidence that people eat better diets, or domore exercise, simplybecause they are told to. They are more likely change theirbehaviour when changes in their economic, social, and culturalcontext make it easy for them to do so. This requires majorshifts in—for example—national policy, driven by public health.Such shifts are harder to deliver and fund than drugs or advice.There are similar challenges in delivering the informationrevolution necessary for informed choice on mass prescription.Doctors are unlikely to start giving patients clear numericalinformation simply because they are told to do so. They mightdo so if NICE can recommend information tools with the sameforce as when it recommends drugs, and if it becomes as easyto give contextual numerical advice as it is to print aprescription. Similarly, history shows that trials on importantdifficult questions will not appear simply because we needknowledge. They will flow more freely if we can removedisproportionate regulatory barriers, reduce the cost ofinformation, and make trial participation convenient anduncomplicated.Mass prescription for modest individual benefit is new. Trulyinformed choice will require more than good intentions. Wewill need better data, from bigger trials, and better riskcommunication than for conventional medical treatment.Delivering this will require us to embed the gathering,communication, and implementation of evidence as seamlesslyand cheaply as possible into the everyday routine of medicine.Without such innovation in the use of medical data, we can sayonly that statins are—broadly speaking—likely to domore goodthan harm. That is not good enough.Competing interests: We have read and understood BMJ policy ondeclaration of interests and declare the following interests: BG receivesincome from writing and speaking for lay audiences on problems inevidence based medicine. LS and BG are involved in various projectsaround the use of low cost trials in the NHS.Provenance and peer review: Commissioned; not externally peerreviewed.1 National Institute for Health and Care Excellence. National costing report: lipid modification(CG181). 2014. www.nice.org.uk/guidance/cg181/resources/cg181-lipid-modification-update-costing-report2.2 National Institute for Health and Care Excellence. Lipid modification: cardiovascular riskassessment and the modification of blood lipids for the primary and secondary preventionof cardiovascular disease. CG181. 2014. www.nice.org.uk/guidance/CG181/.3 Rabar S, Harker M, O’Flynn N, Wierzbicki AS. Lipid modification and cardiovascular riskassessment for the primary and secondary prevention of cardiovascular disease: summaryof updated NICE guidance. BMJ 2014;349: g4356.4 McPherson K. Concerns about the latest NICE draft guidance on statins. BMJ2014;349:g4130.5 Goldacre B. Meta-analysis of side effects of statins shows need for trial transparency.BMJ 2014;348:g2940.6 Wise J. Open letter raises concerns about NICE guidance on statins.BMJ 2014;348:g3937.7 Staa TP, Goldacre B, Gulliford M, Cassell J, Pirmohamed M, Taweel A, et al. Pragmaticrandomised trials using routine electronic health records: putting them to the test. BMJ2012;344:e55.8 Van Staa TP, Dyson L, McCann G, Padmanabhan S, Belatri R, Goldacre B, et al. Theopportunities and challenges of pragmatic point-of-care randomised trials using routinelycollected electronic records: evaluations of two exemplar trials. Health Technol Assess2014;18:1-146.9 Stacey D, Légaré F, Col NF, Bennett CL, Barry MJ, Eden KB, et al. Decision aids forpeople facing health treatment or screening decisions. Cochrane Database Syst Rev2014;1:CD001431.10 Mayo Clinic. Cardiovascular prevention decision aids. 2012. http://shareddecisions.mayoclinic.org/decision-aids-for-chronic-disease/cardiovascular-prevention/.11 Elwyn G, Laitner S, Coulter A, Walker E, Watson P, Thomson R. Implementing shareddecision making in the NHS. BMJ 2010;341:c5146.12 National Institute for Health and Care Excellence. Taking further steps to tackle the riskfrom heart attacks and strokes. 2014. www.nice.org.uk/News/Press-and-Media/taking-further-steps-to-tackle-the-risk-from-heart-attacks-and-strokes.Cite this as: BMJ 2014;348:g4745© BMJ Publishing Group Ltd 2014For personal use only: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribeBMJ 2014;349:g4745 doi: 10.1136/bmj.g4745 (Published 23 July 2014) Page 2 of 2EDITORIALS

Mass treatment with statins.

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Mass treatment with statins.

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