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FROM THE FRONTLINE Evidence based medicine is broken Des Spence general practitioner, Glasgow Evidence based medicine (EBM) wrong footed the drug industry for a while in the 1990s. We could fend off the army of pharmaceutical representatives because often their promotional material was devoid of evidence. But the drug industry came to realise that EBM was an opportunity rather than a threat. Research, especially when published in a prestigious journal, was worth more than thousands of sales representatives. Today EBM is a loaded gun at clinicians’ heads. “You better do as the evidence says,” it hisses, leaving no room for discretion or judgment. EBM is now the problem, fueling overdiagnosis and overtreatment. 1 You see, without so called “evidence” there is no seat at the guideline table. This is the fundamental “commissioning bias,” the elephant in the room, because the drug industry controls and funds most research. So the drug industry and EBM have set about legitimising illegitimate diagnoses and then widening drug indications, and now doctors can prescribe a pill for every ill. The billion prescriptions a year in England in 2012, up 66% in one decade, 2 do not reflect a true increased burden of illness nor an ageing population, 3 just polypharmacy supposedly based on evidence. The drug industry’s corporate mission is to make us all sick however well we feel. 4 As for EBM screening programmes, these are the combine harvester of wellbeing, producing bails of overdiagnosis and misery. Corruption in clinical research is sponsored by billion dollar marketing razzmatazz and promotion passed off as postgraduate education. By contrast, the disorganised protesters have but placards and a couple of felt tip pens to promote their message, and no one wants to listen to tiresome naysayers anyway. How many people care that the research pond is polluted, 5 with fraud, sham diagnosis, short term data, poor regulation, surrogate ends, questionnaires that can’t be validated, and statistically significant but clinically irrelevant outcomes? Medical experts who should be providing oversight are on the take. Even the National Institute for Health and Care Excellence and the Cochrane Collaboration do not exclude authors with conflicts of interest, who therefore have predetermined agendas. 67 The current incarnation of EBM is corrupted, let down by academics and regulators alike. 8 What do we do? We must first recognise that we have a problem. Research should focus on what we don’t know. We should study the natural history of disease, research non-drug based interventions, question diagnostic criteria, tighten the definition of competing interests, and research the actual long term benefits of drugs while promoting intellectual scepticism. If we don’t tackle the flaws of EBM there will be a disaster, but I fear it will take a disaster before anyone will listen. Competing interests: I have read and understood the BMJ Group policy on declaration of interests and have no relevant interests to declare. Provenance and peer review: Commissioned; not externally peer reviewed. 1 Moynihan R. Preventing overdiagnosis: how to stop harming the healthy. BMJ 2012;344:e3502. 2 Health and Social Care Information Centre. Prescription cost analysis England 2012. April 2013. https://catalogue.ic.nhs.uk/publications/prescribing/primary/pres-cost-anal-eng- 2012/pres-cost-anal-eng-2012a-rep.pdf. 3 Spijker J. Population ageing: the timebomb that isn’t? BMJ 2013;347:f6598. 4 Centers for Disease Control and Prevention. Mental health basics. 2011. www.cdc.gov/ mentalhealth/basics.htm. 5 Cohen D. FDA official: “clinical trial system is broken”. BMJ 2013;347:f6980. 6 The Cochrane Collaboration. Conflicts of interest and Cochrane Reviews. August 2013. www.cochrane.org/editorial-and-publishing-policy-resource/conflicts-interest-and-cochrane- reviews. 7 National Institute for Health and Clinical Excellence. Advisory body recruitment pack. September 2007. www.nice.org.uk/media/134/39/CodePractice2AdvisoryBodyQuickGuide. pdf. 8 Light DW. Risky drugs: why the FDA cannot be trusted. Harvard University Edmond J. Safra Center for Ethics. www.ethics.harvard.edu/lab/blog/312-risky-drugs. [email protected] For personal use only: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribe BMJ 2014;348:g22 doi: 10.1136/bmj.g22 (Published 3 January 2014) Page 1 of 2 Views & Reviews VIEWS & REVIEWS

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Page 1: Evidence based medicine is broken

FROM THE FRONTLINE

Evidence based medicine is brokenDes Spence general practitioner, Glasgow

Evidence basedmedicine (EBM)wrong footed the drug industryfor a while in the 1990s. We could fend off the army ofpharmaceutical representatives because often their promotionalmaterial was devoid of evidence. But the drug industry cameto realise that EBM was an opportunity rather than a threat.Research, especially when published in a prestigious journal,was worth more than thousands of sales representatives. TodayEBM is a loaded gun at clinicians’ heads. “You better do as theevidence says,” it hisses, leaving no room for discretion orjudgment. EBM is now the problem, fueling overdiagnosis andovertreatment.1

You see, without so called “evidence” there is no seat at theguideline table. This is the fundamental “commissioning bias,”the elephant in the room, because the drug industry controls andfunds most research. So the drug industry and EBM have setabout legitimising illegitimate diagnoses and then wideningdrug indications, and now doctors can prescribe a pill for everyill. The billion prescriptions a year in England in 2012, up 66%in one decade,2 do not reflect a true increased burden of illnessnor an ageing population,3 just polypharmacy supposedly basedon evidence. The drug industry’s corporate mission is to makeus all sick however well we feel.4 As for EBM screeningprogrammes, these are the combine harvester of wellbeing,producing bails of overdiagnosis and misery.

Corruption in clinical research is sponsored by billion dollarmarketing razzmatazz and promotion passed off as postgraduateeducation. By contrast, the disorganised protesters have butplacards and a couple of felt tip pens to promote their message,and no one wants to listen to tiresome naysayers anyway.How many people care that the research pond is polluted,5 withfraud, sham diagnosis, short term data, poor regulation, surrogateends, questionnaires that can’t be validated, and statisticallysignificant but clinically irrelevant outcomes? Medical expertswho should be providing oversight are on the take. Even theNational Institute for Health and Care Excellence and theCochrane Collaboration do not exclude authors with conflictsof interest, who therefore have predetermined agendas.6 7 Thecurrent incarnation of EBM is corrupted, let down by academicsand regulators alike.8

What dowe do?Wemust first recognise that we have a problem.Research should focus on what we don’t know.We should studythe natural history of disease, research non-drug basedinterventions, question diagnostic criteria, tighten the definitionof competing interests, and research the actual long term benefitsof drugs while promoting intellectual scepticism. If we don’ttackle the flaws of EBM there will be a disaster, but I fear itwill take a disaster before anyone will listen.

Competing interests: I have read and understood the BMJ Group policyon declaration of interests and have no relevant interests to declare.Provenance and peer review: Commissioned; not externally peerreviewed.

1 Moynihan R. Preventing overdiagnosis: how to stop harming the healthy. BMJ2012;344:e3502.

2 Health and Social Care Information Centre. Prescription cost analysis England 2012. April2013. https://catalogue.ic.nhs.uk/publications/prescribing/primary/pres-cost-anal-eng-2012/pres-cost-anal-eng-2012a-rep.pdf.

3 Spijker J. Population ageing: the timebomb that isn’t? BMJ 2013;347:f6598.4 Centers for Disease Control and Prevention. Mental health basics. 2011. www.cdc.gov/

mentalhealth/basics.htm.5 Cohen D. FDA official: “clinical trial system is broken”. BMJ 2013;347:f6980.6 The Cochrane Collaboration. Conflicts of interest and Cochrane Reviews. August 2013.

www.cochrane.org/editorial-and-publishing-policy-resource/conflicts-interest-and-cochrane-reviews.

7 National Institute for Health and Clinical Excellence. Advisory body recruitment pack.September 2007. www.nice.org.uk/media/134/39/CodePractice2AdvisoryBodyQuickGuide.pdf.

8 Light DW. Risky drugs: why the FDA cannot be trusted. Harvard University Edmond J.Safra Center for Ethics. www.ethics.harvard.edu/lab/blog/312-risky-drugs.

[email protected]

For personal use only: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribe

BMJ 2014;348:g22 doi: 10.1136/bmj.g22 (Published 3 January 2014) Page 1 of 2

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Cite this as: BMJ 2014;348:g22 © BMJ Publishing Group Ltd 2014

For personal use only: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribe

BMJ 2014;348:g22 doi: 10.1136/bmj.g22 (Published 3 January 2014) Page 2 of 2

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