BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g22 (Published 3 January 2014)
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
- 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.6 7 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 r
- esearch 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.
Follow Des Spence on Twitter @des_spence1
0 Moynihan R. Preventing overdiagnosis: how to stop harming the healthy. BMJ2012;344:e3502. FREE Full Text
1 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.
2 Spijker J. Population ageing: the timebomb that isn’t? BMJ2013;347:f6598. FREE Full Text
3 Centers for Disease Control and Prevention. Mental health basics. 2011. www.cdc.gov/mentalhealth/basics.htm.
4 Cohen D. FDA official: “clinical trial system is broken”. BMJ 2013;347:f6980. FREE Full Text
5 The Cochrane Collaboration. Conflicts of interest and Cochrane Reviews. August 2013. www.cochrane.org/editorial-and-publishing-policy-resource/conflicts-interest-and-cochrane-reviews.
6 National Institute for Health and Clinical Excellence. Advisory body recruitment pack. September 2007. www.nice.org.uk/media/134/39/CodePractice2AdvisoryBodyQuickGuide.pdf.
7 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.
Derek K-H. Ho, FY1 Doctor
St Thomas' Hospital, Westminster Bridge Rd, London SE1 7EH: 4 January 2014
The author pointed out an important observation in modern medical research; that the drug industry has managed to exploit EBM for its own benefit. Indeed, it is well known that published researches funded by pharmaceutical companies are more likely to yield favourable outcomes, without displaying obvious methodological flaws that would otherwise alarm an average reader. (1-2) Reporting and publication biases have been suggested to play a key role in this.
The statement that 'Evidence based medicine is broken' seems rather unfair, however. To the healthcare professionals and the informed public, the ability to critically appraise a piece of research enables us to judge the evidence ourselves. Popular books by 'campaigners' such as Dr Ben Goldacre, and charity groups including Sense about Science and HealthWatch have been promoting just that for many years. (3-5)
While NICE and the Cochrane Collaboration do include studies by researchers with conflicts of interest in their reviews, it should be up to the reviewers and subsequent readers to make the interpretation. Assessing for conflicts of interest in included trials is a routine component of a Cochrane systematic review, and there was recently a debate whether to include funding source as a standard item in the risk of bias table. (6) Statistical approach such as the funnel plot is also helpful in detecting for publication bias. (7)
1. Schott et al. The Financing of Drug Trials by Pharmaceutical Companies and Its Consequences. Dtsch Arztebl Int 2010; 107(16): 279–85.
2. Lexchin et al. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003; 326: 1167.
6. Methods Symposium Quebec Colloquium 2013-Programme slides (http://methods.cochrane.org/node/56)
Competing interests: I am an author in the Cochrane Eyes and Vision Group. I am a trainee doctor committee member of HealthWatch charity.