17 October 2008

RCTs “placed on an undeserved pedestal” – head of NICE

I can’t find any other reference to this information apart from as reported by Pharmatimes:

[update: also here and The Independent  ‘Statistics can help but doctors must also use their judgement’ which includes the pleasing statement: ‘It is scientific judgement – conditioned by the totality [my bold] of the evidence – that lies at the heart of making decisions about the benefits and harms of therapeutic interventions]

‘The chairman of the UK’s National Institute for Health and Clinical Excellence (NICE) has suggested randomised controlled trials (RCTs) should no longer be seen as the be-all and end-all of clinical research.

In a speech last night to the Royal College of Physicians, Professor Sir Michael Rawlins said such studies had been placed “on an undeserved pedestal”. He called for other types of research, including observational studies, to be given greater attention.

Professor Rawlins presides over an organisation that has regularly indicated its discontent with clinical evidence supplied by drug manufacturers. For its part, industry has been vocal in its criticisms of NICE’s cost-effectiveness models. More recently, Professor Rawlins has sharply criticised industry pricing practices
for new drugs.

All the same, some may be surprised at his willingness to question the value of RCTs, generally seen as the most rigorous tests for a new medicine, and talk up the benefits of other types of study.

In his speech Professor Rawlins said clinical trials were:

* Virtually impossible to conduct properly when studying treatments for rare diseases with very few patients

* Often prohibitively expensive. He cited a recent study of 153 trials completed in 2005 and 2006, which showed a median cost of over £3 million, with one trial costing £95 million. One manufacturer has estimated that the average cost per patient of a clinical trial rose from £6,300 in 2005 to £9,900 in 2007

* Even “unnecessary” when, as in the case of Novartis’ Glivec (imatinib) for chronic myeloid leukaemia , a treatment produced a particularly “dramatic” benefit

However, Professor Rawlins also expressed concern about the growing tendency, especially in cancer research, for clinical trials to be stopped early.

“The desire to stop trials early is understandable, but the possibility that an interim analysis is a ‘random high’ may be difficult to avoid,” he said. Moreover, there was “no consensus among statisticians as to how best to handle the problem”.

Prof Rawlins also had some criticism for his medical colleagues, many of whom adopted too rigid an approach to clinical research, he claimed, particularly in the trend towards ranking different types of clinical trial in terms of importance.

Hierarchies attempt to replace judgment with an over-simplistic, pseudo-quantitative, assessment of the quality of the available evidence,” he commented.

Accoording to Professor Rawlins, observational studies, historical controlled trials and case-control studies are also important sources of information.

What is needed 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 judgment“, he concluded.’

30 June 2008

Randomised Controlled Trials are the worst of medicine

Over at spiked-online there is a debate on the Best and Worst of Medicine.  Unsurprisingly, skeptics have nominated homeopathy as one of the worst, but the sheer volume of messages of support for homeopathy managed to get a nomination for best as well.

The debate for the worst of medicine is due on the 17th July.  A clinician sums up the current fundamentalist scientistic backlash against CAM with a damning criticism of the RCT and of those who narrowly support it:

Randomised Controlled Trials are the worst 28 May 2008

The worst thing to happen to medicine is undoubtedly the Randomised Clinical Trial (RCT) – not for the information it does and doesn’t give us but for the way it has been used by government and tunnel visioned researchers to qualify some ridiculous practices under the heading “Evidence Based Medicine”.

As clinicians we are ‘encouraged’ (read ‘forced’) to ignore our clinical skills and acumen in favor of flow chart diagnosis and prescribing. It is virtually never mentioned how much morbidity and mortality modern medicine directly causes – recent analysis in the USA places iatrogenic problems as the country’s third biggest killer!

In addition we are using medicines on complicated people, often with multiple diagnoses and on a variety of drugs – RCTs are conducted in strict (non-clinical) settings using young, relatively fit and healthy people. I am always flabbergasted at the conclusions drawn from these to ‘inform’ normal clinic practice – the information is barely ever transferable!

The best thing to happen to modern medicine is the shake-up of the rigid paradigm that is now being forced on the ‘establishment’ by hoards of patients and practitioners giving a huge range of complementary practices their attention and confidence.

The narrow-minded view taken by a radical few is that we don’t know how these modalities work, therefore they can’t work. This attitude clearly needs to be counterbalanced by the many hundreds of thousands of people who use these treatments and (RCT be damned) find that they work!

Scientific curiosity, informed by actually hearing what people are saying, is the only way forward. Retire any ‘scientist’ who is not actively demonstrating a flexible and curious approach to investigating these complementary therapies, suspending thier predjudice and bias – after all, is this not the DEFINITION of a real scientist?

Geoff Woodin, UK

Edzard Ernst, take note.

4 June 2008

Edzard Ernst’s uncritical endorsement of EBM is ’empirical quackery’

Dr Michael Fitzpatrick’s review of the book ‘Trick or Treatment’ by Simon Singh and Edzard Ernst at  spiked-online (they say: “an independent online phenomenon dedicated to raising the horizons of humanity by waging a culture war of words against misanthropy, priggishness, prejudice, luddism, illiberalism and irrationalism in all their ancient and modern forms”) makes the following observations and criticisms of interest:

“Despairing of their capacity to engage with serious adversaries or big issues, former left-wingers are inclined to re-fight the battles of the past and to seek out soft targets for their invective: current favourites include neo-fascists, creationists and conservative religionists. Though any small success of these forces is trumpeted as a menace to civilisation, in reality they are as marginal as they have ever been. Exaggerating these threats enables liberals to imagine a return to their glory days, and allows them to evade the real problems of the present.”

“Alternative medicine, the focus of a new critique titled Trick or Treatment? by the science writer Simon Singh and Edzard Ernst, ‘the world’s first professor of complementary medicine’, has become another target of the radical backlash. Following the spectacular success of a series of works promoting militant secularism, a spate of books and blogs now signals a new crusade against alternative medicine.”

“it is light on references”

“My reservations about Trick or Treatment? concern its uncritical endorsement of what the health policy expert Rudolph Klein has characterised as the ‘new scientism’ of ‘evidence-based medicine’ (1), its incoherent advice to doctors on telling the truth and its curiously paternalistic approach towards patients.

According to Singh and Ernst, ‘evidence-based medicine’, a term coined by the epidemiologist David Sackett in 1992, has ‘revolutionised medical practice’. They acknowledge that ‘prior to the development of evidence-based medicine, doctors were spectacularly ineffective’. However, ‘once the medical establishment had adopted such simple ideas as the clinical trial, then progress became swift’. As a result, ‘today’, less than two decades later, according to this remarkable telescoping of the familiar narrative of progress from darkness to enlightenment, ‘the clinical trial is routine in the development of new treatments and medical experts agree that evidence-based medicine is the key to effective health care’.

While it is true that evidence-based medicine (EBM) has made some useful contributions to contemporary medical practice, notably in the systematic use of randomised controlled trials in the study of therapeutic interventions, it is nonsense to claim that it has played a major role in the successes of modern medicine (such as vaccines, antibiotics, steroids, anaesthetics, surgical techniques) which arose from developments in the basic medical sciences.”

“To some of its critics, in its disparagement of theory and its crude number-crunching, EBM marks a return to ‘empiricist quackery’ in medical practice.”

“Why are so many GPs tolerating, promoting or even using bogus treatments?’ is the provocative question posed by Singh and Ernst to my colleagues in primary health care. They consider various possibilities (though they do not seem to apply their commitment to an evidence-based approach to their speculations in this area). Could it be that GPs are simply ignorant of the facts that alternative medicine is useless? They raise the possibility that some GPs may be true believers in alternative therapies, but – understandably – find this too terrifying a subject to investigate further. They believe that many GPs are so inconsiderate towards their patients that this drives them into the sympathetic, empathetic arms of alternative therapists. But for them the most likely explanation is that GPs are simply lazy and respond to their patients’ relentless minor complaints by ‘fobbing them off with placebos’, in the form of ‘bogus remedies’ and referrals to alternative therapists.”

“Singh and Ernst criticise GPs for ‘encouraging patients’ to seek out alternative therapists. In a bizarre parallel with the world of drug addiction, they argue that ‘introducing patients to alternative therapists in relation to a minor condition could act as a gateway to a longer-term reliance’. One taste of a (tasteless) homeopathic pill or twist of an acupuncture needle could lead to a serious habit, and they may end up refusing vaccinations and stopping prescription drugs.

This is getting silly.”

I have received the following further comments from Ralf Jeutter PhD RSHom:

“The quotes from the book presented by Fitzpatrick show how superficial Singh and Ernst’s critique is. It is primarily based on the assumption that EBM is a reliable tool with which to judge treatments, totally ignoring that EBM is far from accepted as that.  Fitzpatrick calls it ‘incoherent advice to doctors’; the ‘founder’ of EBM, Sackett, wrote: ‘EBM … never replaces clinical skills, clinical judgment and clinical experience’, thus refuting in one single sentence everything Ernst claims: that EBM is the most reliable and generally accepted standard for assessing clinical effectiveness.

Ernst is a dramatiser who has lost perspective of real academic/scientific issues when he writes that ‘prior to the development of evidence-based medicine, doctors were spectacularly ineffective.’ If he really means this it is clear that he has an utterly uncritical enthusiasm for what is only the latest fashion in medicine, one that is neither established nor universally accepted. The one appeal it has is its mind numbing simplicity, which totally ignores clinical realities.

The review also highlights how desperate Ernst is to find ANYTHING to discredit CAM: apparently it is habit forming on a par with, well, seriously habit forming things. Rightly Fitzpatrick says: ‘This is silly’.

Ernst loses academic credibility by refusing to acknowledge the real complexity of research into CAM. Moreover he refuses to acknowledge that most conventional treatments and interventions are not evidence based. He has found a way of making headlines by propagating very crude science indeed. His academic status is further undermined by acting much more like a quackbuster of recent years than as somebody who should be encouraging more research (including research methodologies into CAM) to benefit the profession and patients.

It really does not become a Professor of CAM to dismiss such a longstanding and successful practice like homeopathy as ‘bogus’ and ‘nonsense’. As an academic he has had to make a determined effort to ignore the plethora of research which has grown around homeopathy over the last 200 years: pre-clinical fundamental research; fundamental research into physics and chemistry as far as it has a bearing on homeopathy; experiments on plants with ultra-high dilutions; experiments on animals and animal tissue with ultra-high dilutions; in-vitro studies; clinical studies, be they observational or comparative studies; controlled studies of nosological clinical homeopathy to randomised clinical isopathic and epidemiological studies. He has also ignored the dedicated hard work of many researchers into CAM and associated fields: dismissing all of this as useless activity which has yielded nothing and will never yield anything. I think it would suit Prof. Ernst to show more respect to his colleagues and a modicum of modesty.

Ernst has come to the conclusion that homeopathy doesn’t work by cherry-picking what he considers to be state-of-the-art research methodologies, which conflict in many instances with clinical realities.

It appears that it is Ernst’s desire to call a premature end to homeopathy which informs his understanding of ‘science’. Homeopathy has survived many fads, fashions and detractors, and will no doubt survive this latest attempt at discrediting it. In my own modest predicition, Ernst, in all likelihood, will become a footnote in the history of homeopathy, like so many before him.  He is an academic who mistakes scientific models with reality.”

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