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Healthy Skepticism Library item: 14499

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Rawlins criticises traditional methods of assessing evidence
PM Live 2008 Oct 15
http://www.pmlive.com/pharm_market/news.cfm?showArticle=1&ArticleID=7115


Full text:

In this year’s Harveian Oration, delivered before the Fellows of The Royal College of Physicians of London on Thursday October 16, 2008, Professor Sir Michael Rawlins, Chair of the National Institute for Health and Clinical Excellence (NICE), argues that a new approach to analysing clinical evidence is required.

According to Sir Michael’s oration, randomised controlled trials (RCTs) have been put on an undeserved pedestal. Despite being billed as “the gold standard” for demonstrating (or refuting) the benefits of a particular intervention, Sir Michael claims RCTs have important limitations and imperfections, including inappropriateness, utility of the null hypothesis, theories of probability, generalisability of the results and resource implications. He states that their appearance at the top of “hierarchies” of evidence is inapt; and hierarchies, themselves, are illusory tools for assessing evidence.

Sir Michael recommends that RCTs be replaced by a diversity of approaches that involve analysing the totality of the evidence-base. In his opinion, observational studies are useful and, with care in the interpretation of the results, can provide an important source of evidence about both the benefits and harms of therapeutic interventions. In particular these include historical controlled trials and case-control studies, but other forms of observational data can also reveal important issues.

Sir Michael rejects the trend towards grading various kinds of clinical trials and studies on scales of merit, which he says have come to dominate the development of some aspects of clinical decision-making.

Arguments about the relative importance of different kinds of evidence are an unnecessary distraction, he claims. What is needed instead is for “investigators to continue to develop and improve their methodologies; for decision makers to avoid adopting entrenched positions about the nature of evidence; and for both to accept that the interpretation of evidence requires judgement”.

In conclusion, Sir Michael states: “I am aware that those who develop and use hierarchies of evidence are attempting to replace judgements with what, in their eyes, is a more reliable and robust approach to assessing evidence. All my experience tells me they are wrong. It is scientific judgement – conditioned, of course, by the totality of the available evidence – that lies at the heart of making decisions about the benefits and harms of therapeutic interventions”.

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909