Evidence-Based Medicine or Ignorance-Based Evidence
September 28, 2011
New peer reviewed papers published today Wednesday September 28th 2011 in the International Journal of Person Centered Medicine reveal Evidence-Based Medicine [EBM], the reigning medical paradigm for the practice of modern medicine for the past 30 years, as an inevitable failure from its inception and that the “Gold Standard” of evidence in modern medicine, randomised controlled trials [RCTs] as currently practised should be abandoned. The irony of EBM’s failure is that its proponents over the past 30 years simultaneously claimed the scientific high ground whilst having failed to adopt a scientific approach to EBM’s foundations. EBM is fatally philosophically wounded.
Penston, J (2011). “The Irrelevance of Statistics-Based Research to Individual Patients”, The International Journal of Person Centered Medicine 1, 2, 240-249.
Miller, CG; Miller, DW “The Real World Failure of Evidence-Based Medicine” IJPCM 2011 1,2 295-300
The second of the above cited papers is by Clifford Miller and Professor Donald Miller. It asks whether EBM “may have to be consigned to the wastebasket of medical mistakes, alongside bleeding people in the 17th and 18th centuries and treating syphilis with mercury in the 19th and early 20th centuries”.
This puts in question the reliability of the formal medical journal published evidence base underpinning modern medical research and practice. The impact is on medicine and its practice is at every level internationally. Evidence-Based Medicine was doomed from its inception, lacking logical, scientific and theoretical foundations. Large scale RCTs are used universally to prove the safety and efficacy of new drugs but commonly used to claim “small” treatment effects. This means in that in the majority of recipients, the drugs are shown to have no effect. In only small numbers are effects claimed and those claims are shown now to be based on flawed premises where even the claimed effect may not exist.
Randomised controlled trials and epidemiological studies provide the grounds for much of clinical medicine and consequently affect the lives of millions of patients around the world. But this statistics-based research offers little to individual patients.
The ability to generalise the results of these studies to the wider population of patients is unsuccessful. External validity is brought into question by the selection involved in the recruitment process and in the participation in clinical trials. Thus, we cannot know with any confidence to whom the results apply and this has obvious implications for individual patients. Yet, there is a further problem: conventional statistical analysis involves the frequentist approach which entails that probabilities only apply to classes. Hence, the results of this type of research are not strictly applicable to individuals.
But even if we set aside the difficulties associated with external validity, there is a more important problem which relates to the size of the treatment effect. Large-scale studies entail that any treatment effect detected will be very small. While this is often hidden by the use of relative risk reductions, once the absolute treatment difference is presented, the paltry size of the benefit becomes clear. This has little importance or relevance to the lives of individual patients and, as is argued, has doubtful meaning.
Current medical practice encourages patients’ participation in decisions regarding their care and this includes providing them with sufficient information to enable them to make informed choices about their treatment. However, were they to be told about the problems with external validity and the true size of the benefit – not to mention the many other problems with statistics-based research – it is likely that far fewer would accept treatment than is currently the case.
Further reference may be had to the recent book by British NHS medical doctor Dr James Penston “Stats.con – How we’ve been fooled by statistics-based research in medicine.” The London Press. London, November 2010.
As a way to make medical decisions, Evidence-Based Medicine (EBM) has failed. EBM’s failure arises from not being founded on real-world decision-making. EBM aspires to a scientific standard for the best way to treat a disease and determine its cause, but it fails to recognise that the scientific method is inapplicable to medical and other real-world decision-making. EBM also wrongly assumes that evidence can be marshaled and applied according to an hierarchy that is determined in an argument by authority to the method by which it has been obtained. If EBM had valid theoretical, practical or empirical foundations, there would be no hierarchy of evidence. In all real-world decision-making, evidence stands or falls on its inherent reliability. This has to be and can only be assessed on a case-by-case basis applying understanding and wisdom against the background of all available facts—the “factual matrix.” EBM’s failure is structural and was inevitable from its inception. EBM confuses the inherent reliability and probative value of evidence with the means by which it is obtained.
EBM is therefore an ad hoc construct and is not a valid basis for medical decision-making. This is further demonstrated by its exclusion of relevant scientific and probative real-world decision-making evidence and processes. It draws upon a narrow evidence base that is itself inherently unreliable. It fails to take adequate account of the nature of causation, the full range of evidence relevant to its determination, and differing approaches to determining cause and effect in real-world decision-making. EBM also makes a muddled attempt to emulate the scientific method and it does not acknowledge the role of experience, understanding and wisdom in making medical decisions.