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The ill-fated TGN1412 phase I study and Prince Charles versus the medical establishment over complementary therapies recently pushed evidence-based medicine and clinical trials into prominence. For a society with poor vocabulary about probability, risk and uncertainty, and which increasingly blurs boundaries between well and ill, moving the debates forward, and in unity, will be tough.
Prince Charles called for orthodox medicine to learn from alternative, telling the World Health Assembly in Geneva ‘The proper mix of proven complementary, traditional and modern remedies, which emphasizes the active participation of the patient, can help to create a powerful healing force in the world’. Which begs the question ‘What's the proof?’. In parallel, 13 eminent doctors wrote to acute and primary care trusts urging them to review practices with regard to ‘ways in which unproven or disproved treatments are being encouraged for general use in the NHS’.1
About half of all general practitioners refer patients to alternative practitioners, and should stop if it is pointless. As clinical scientist Leslie Rose said, the letter was to ‘instill equal vigour in gathering evidence for every treatment prescribed to NHS patients’, adding that a business plan for refurbishing the Royal London Homoeopathic Hospital—which cost £20m to set up—put no emphasis on evidence. £20m can buy a lot of what works, and such support begs questions about government consistency in calling for hard evidence for healthcare.
The hospital's Dr Peter Fisher described the letter as an attempt to introduce ‘medical apartheid’ into the National Health Service, and Terry Cullen, of the British Complementary Medicine Association, said: ‘There is so much anecdotal evidence that thousands of people gain benefit from using complementary medicines. We shouldn't dismiss that’.
He is right: which is where a major problem arises—confusing treating illness with ‘gaining benefit’, and indeed anecdote with evidence. The World Health Organization defines health as ‘a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity’.2. But the NHS has enough to do without being charged—in both senses—with creating this nirvana. Hoards of sensible, bright people swear by various blends of snake oil for multiple malaises, from back pain to itchy skin to mild melancholy. And maybe it is more powerful. But we need hard evidence that we can cure cancer, bypass a heart or silence schizophrenic voices with homeopathy, reiki, reflexology or aromatherapy. That is not to say they are not useful adjuncts to conventional treatment, or, more importantly, that conventional care equals medicines: the evidence base for talking treatments in some mental illness is excellent.3 But when a hard-pressed NHS has to look after the really unwell, it has got no moral or practical choice but to start by offering what works, and probably to stop there before the money runs out.
Among the very real inherent difficulties in evidence-based medicine is being able to integrate what is best for the individual with what it says in the less personal book of evidence. This takes skill, care and that rare commodity, time: a good clinician will keep one hand on their evidence-based medicine touchstone, while recognizing that what works for him may well not work for me, and may also throw unscientific, non-evidence-based human kindness into the mix, if they can find a moment. A tough but possible call.4 More prosaically, even Homer nods: busy clinicians cannot always be experts in everything, while, in parallel, patients may need to acknowledge that health as defined by the WHO is not the job of the NHS.
An invaluable recent addition to understanding these topics is a book for non-professional readers written by a medical journalist, a breast cancer patient and a medical researcher. Testing Treatments: Better Research For Better Healthcare5 asks about how we know whether a drug or treatment really works, about trial bias, and whether research is really focused on patient benefit.
The book explains why trials are essential to embedding healthcare in evidence. Its ‘blueprint’, distillable into honesty about uncertainty, integrity of industry and more accessible information for all about the state of play, is in part set out in an article by one of its co-authors, Sir Iain Chalmers, former Director of the first Cochrane Centre.6 He is a founder of the James Lind Alliance (Lind was the naval surgeon who carried out a controlled trial of scurvy treatments in 1747),7,8 which is promoting partnerships between patients and professionals to identify important uncertainties about treatments. Chalmers is passionate about the importance of clinical trials, and determined that priorities be influenced by the imperatives of patients and clinicians, as well as academics and industry. He is also working to get the trials concept embedded in the public consciousness through a ‘testing treatments card’. Like an organ donor card, it would state that the holder wishes to be entered into registered, necessary and, ultimately, well-disseminated trials.
It will be interesting to see what emerges, in parallel with the UK Clinical Research Collaboration's work to push clinical trials up the agendas of public awareness and professional feasibility. As long as the curious and potentially dangerous paradox pertains—that it is easier to give a nonevidence-based unlicensed treatment to all your patients than to half of them, because setting up a proper trial can be a bureaucratic nightmare, or because you cannot recruit patients as they do not understand the score—something must be wrong.
Competing interests The author will not gain personally from publication of this article, and these views do not necessarily reflect those of the Association of Medical Research Charities.