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Neil menzies, healthcare analyser London SW6
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It is easy for Godlee and Ernst to deride the 'evidence' provided by the chiropractors. By current standards it doesn't stand up to scrutiny as ably illustrated by Ernst. But what conclusions should we draw from this? Does it mean that chiropractic is base quackery out to dupe a gullible public and use legal muscle to avert dissent? Personally I think not. Ernst has for a long time gunned for chiropractic, over-stating the dangers and understating the benefits. Should treatment be allowed only if it satisfies an RCT, the gold standard, and all other evidence be ignored, as seems to be Ernst's approach? If so, then outlaw the 87% of common medical treatments that are unproven as beneficial (http://clinicalevidence.bmj.com/ceweb/about/knowledge.jsp). Would this be in patients best interest? If not, then perhaps clinicians need "to withstand the domination of authority" from non-clinicians and assert what is obvious daily, namely that, while research evidence is essential and helps inform clinical practice, individual patients require an individual approach, and that most treatments are unsuitable for assessment by RCT. Where is the evidence that a treatment approach based purely on RCTs results in better patient outcomes? It seems that we all are required to believe in science as we once believed in religion and to see science as the source of wisdom rather than the tool it is and should be. Beware, as Hannah Arendt remarked in "The Origins of Totalitarianism ": 'Ideological thinking becomes emancipated from the reality that we perceive with our five senses, and insists on a "truer" reality concealed behind all perceptible things, dominating them from this place of concealment'. Clearly chiropractors find in their clinical practice that some paediatric conditions can be helped safely and we must assume that they go about this in a professional manner. The truly scientific approach would be to try and find out more rather than take an arbitrary standard and then seek to denigrate them. Competing interests: None declared |
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Lionel R Milgrom, sientist, writer, homeopath NW2 3ES
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The Guardian newspaper may well have invited the BCA to lay out its evidence ‘stall’ for chiropractic, but what Fiona Godlee's editorial fails to mention is that Dr Singh’s original article alleged the BCA promotes 'bogus' treatments.1 It is this statement that the judge agreed was libellous, because by being ‘factually wrong, defamatory, and a damaging allegation that could be seen to adversely affect the professional reputations of individuals or organisations’,2 it implied chiropractors are knowingly mendacious. The BCA went to court because Dr Singh refused to retract this statement not, as your editorial seems to suggest, to wage a campaign against freedom of expression or proper scientific debate. Indeed, perpetuating this myth demonstrates the difficulty of having any reasoned debate about CAM. Real debate is a balance of opposing views, and in the media these are hardly allowed column inches or air-time. The evidence base for CAM, particularly as it exists in complex clinical settings is dismissed out of hand when it is thought to contradict one particular version of scientific thinking. Dr Singh and Prof Ernst are well known for their views on CAM, most of which they excoriate as unscientific; unproven; even dangerous and downright deadly. These are demonstrably false claims that go relatively unchallenged, especially as they exist in a climate where conventional medical blunders are commonplace.3 Such unrelenting bias against CAM does not lend itself to constructive debate or free speech. Much of Dr Singh’s and Prof Ernst’s ire against CAM stems from a particular scientific mind set (logical positivism) which they appear to regard as incontrovertible truth.4 For understanding the workings of washing machines, guns, and rockets, etc, it is perfectly adequate. When applied to medicine (as much an art as it is a science) however, it effectively downgrades or ignores other important less scientifically defined forms of evidence. The result is that clinical decisions are now supposed to be based solely on the scientific evidence, which incidentally was never the intention of those who originally formulated the tenets of Evidence-Based Medicine (EBM).5 The irony here is that if such a draconian approach was to be enforced throughout medicine, nearly half of all current procedures would have to be withheld until much time and expenditure had ‘proven’ their effectiveness.6 Such a procedure could turn out to be a double-edged sword. Trials of one of the biggest selling drugs Prozac, for example recently found it to be no better than placebo.7 Interestingly one does not hear Dr Singh or Prof Ernst campaigning for the removal of Prozac, as they do so vociferously against CAM. Fortunately, wiser councils in medicine may still prevail, and not all (e.g., chair of NICE, Sir Michael Rawlins) subscribe to the kind of scientific ‘fundamentalism’ Dr Singh and Prof Ernst would wish to see foisted upon them.8 Indeed, as cancer clinician Karol Sikora has trenchantly remarked, they do not take kindly to being lectured to by ‘inexperienced’, ‘armchair physicians’.9 Lastly, in the case of Dr Singh, your call for readers to sign up to ‘organised scepticism’ misses a rather important point. The campaign to keep the libel laws out of science, if successful, would in effect result in the conflation of what is now considered libellous comment with serious scientific criticism. Under these circumstances, such a campaign could quite easily be interpreted as an attempt to place scientists and science writers above the law: as if science in the UK isn't presently in enough difficulty that it needs to go adding hubris to its list of woes. Yours Sincerely Lionel R Milgrom LCH MARH MRHom BSc MSc PhD CChem FRSC References 1. Singh S. Beware the spinal trap, The Guardian. Saturday, 19th April 2008. The original Guardian piece was withdrawn. This version from the website, http://svetlana14s.narod.ru/Simon_Singhs_silenced_paper.html was accessed 10th June 2009. 2. See, http://www.chiropractic-uk.co.uk/default.aspx?m=1&mi=1. Accessed 10th June 2009. 3. Leigh E. A safer place for patients: Learning to improve patient safety. 51st report of session 2005–06 report, together with formal minutes, oral, and written evidence. House of Commons papers 831 2005–06, TSO (The Stationery Office). July 6, 2006. 4. Okasha S. Philosophy of science: a very short introduction. Oxford University Press, 2002. 5. Sackett, D.L. et al. (1996) Evidence based medicine: what it is and what it isn't. BMJ 312 (7023), 13 January, 71-72. 6. See, http://clinicalevidence.bmj.com/ceweb/about/knowledge.jsp. Accessed 11th July 2009. 7. Kirsch I, Deacon BJ, Huendo-Medina T, Scoboria A, Moore TJ, Johnson BT. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med 2008;5(2): e45. 8. Rawlins M. De Testimonio: Harveian Oration Delivered to the Royal College of Physicians, London 16th October 2008. http://www.rcplondon.ac.uk/news/news.asp?PR_id_422. Accessed November 1, 2008. 9. Sikora K. Complementary medicine does help patients. Times Online, February 3rd 2009. Online document at: www.timesonline.co.uk/tol/life_and_style/court_and_social?article5644142.ece Accessed February 18, 2009. Competing interests: None declared |
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Richard Rawlins, Consultant orthopaedic Surgeon Dartmouth TQ6 0BS
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The proposal that the BMA should monitor this matter was on the Agenda for the recent BMA ARM, but time did not allow debate. Nevertheless it is much to be hoped that Council will develop policies to enable members and the profession generally to express views and opinions about the efficacy of health care interventions without fearing legal action from those who find such opinions unfavourable. Surely it should be a given that in discussions about health care interventions 'evidence' should be credible and scientifically sound, and not simply accepted on the basis that someone somewhere thinks they have identified an effect. Surely that would be an inadmissible use of the term. Even the courts do not recognize inadmissible evidence. Let us hypothesize that a scientist/doctor who is investigating health care treatments finds not a jot of (admissible) evidence for claims of efficacy being made about a certain intervention, and that rational healthcare practitioners who are still in good standing with their regulatory body demonstrably know of the same lack of admissible evidence - then surely any claims based on that evidence must be false. In other words - 'bogus' and with the potential to mislead patients. In those circumstances, what should the scientist/doctor do? Remain silent? In the present case of chiropractic the issue is not whether such intervention works or not, nor for what conditions, but the meaning and nature of 'evidence' and 'truth/falsehood'. Important considerations, but metaphysical not scientific, and the courts are no place for metaphysics. The Collins Dictionary defines 'defamation' as "to attack the good reputation of someone by making unfavourable statements about them". So, if a doctor/practitioner makes a statement that "x has a beneficial effect on y", then any statement in refutation must necessarily be unfavourable to the original proponent. By suggesting they are intellectually wrong, there will be an attack on their reputation for honesty. The BMJ contains numerous articles making statements which are unfavourable to various practitioners. That is the nature, indeed, purpose of medical publishing. Given the Collins' definition, by the very fact of articles being unfavourable, such articles are defamatory. But if that were not to be tolerated, the BMJ, and all scientific journals would have to cease publication. It must be bourn in mind that most members of the public do not understand the nature of 'evidence'. So how are they to be informed about claims which are false, which are promoted by professional practitioners who know of the baselessness and therefore bogusness of the claims? I call for honesty in health care. Science, not semantics. 'Science' is not perfect, but tries to be. It is a means to an end, not an end in itself. But it is the best system we have. Never mind libel, keep metaphysics out of the courts! Competing interests: None declared |
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Trisha Greenhalgh, Professor of Primary Health Care University College London
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The title of Fi's piece - keep libel out of science - is spot on. The rapid response discussion so far seems to be hinging on whether SS calling the BCA's activity 'bogus' was or wasn't libel. That is not the issue. Had I been sent SS's original piece to peer review, I would probably have said something like "I fully accept the author's case that there appears to be limited RCT evidence for the efficacy of chiropractic in particular conditions, but the use of the term 'bogus' seems both unprofessional and unscholarly. The argument would be stronger if expressed in more reserved terms." In other words, I would have applied the norms and standards of academic scholarship, not some legal benchmark of defamation. Let's redraw the battle lines from libel/non-libel to professional/unprofessional or scholarly/unscholarly. I'm sure we'd then have a more frutiful debate, since the key unresolved issue is surely whether and how scientific critique should be censored. Competing interests: None declared |
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Joe Magrath, Retired chemist N/A
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Neil Menzies, above, makes a few mistakes; I will address one. The scientific support for medical procedures is closer to 80%: http://www.shef.ac.uk/scharr/ir/percent.html http://www.veterinarywatch.com/CTiM.htm Most of the rest of the procedures are based in anatomy and physiology. For example, if a person has lost a lot of blood one does not need a clinical trial to know that a transfusion is in order. It would be unethical to conduct a placebo-controlled trial for insulin treatment of type-1 diabetes. The same goes for setting and immobilizing a broken bone. Those procedures are in the 40% "unknown" in the chart Mr. Menzies cites. There is also no reason for him to dismiss the "likely to be beneficial" (23%) group on the chart. Competing interests: None declared |
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John S Garrow, retired physician 93 Uxbridge Road, Rickmansworth, WD3 7DQ
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Predictably, proponents of chiropractic (and other CAM therapies) claim that "87% of common medical treatments that are unproven as beneficial". This is derived from the false assumption that all the "common medical treatments" relate to conventional medical practice, but in fact they are all the 2500 treatments (both conventional and CAM)that were included in the study (see further explanation in the HealthWatch Newsletter issue 68, January 2008). If 13% of 2500 treatment have good evidence of efficacy that means that there are 325 proven effective treatments. How many of these 325 effective treatments were chiropractic for childhood asthma, otitis, colic, feeding problems, sleeping problems, and prolonged crying? You guess it: answer zero. We can extend this comparison of evidence of efficacy to all forms of CAM. How many of the 325 effective treatments are CAM treatment? I cannot do the calculation, but am confident that the proportion will be far less than 13%. I think that proponents of CAM should refrain from deriding evidence of efficacy in conventional medicine until they can show that they have a significant proportion (>13%) who have good evidence of efficacy for CAM treatments. Competing interests: None declared |
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Hazel Thornton, Honorary Visiting Fellow, Department of Health Sciences, University of Leicester. "Saionara", 31 Regent Street, Rowhedge, Colchester. CO5 7EA
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It seems we are losing the art of engaging constructively and civilly in scientific debate. It seems we`ve forgotten how to fight cleanly in the pages of a medical journal, expressing ourselves in a professional, scholarly manner. Perhaps it is because `civility` and `politeness` are thought by many people today to be unnecessary trappings? It is evident from the contributions to this debate, [1] and from those to the concurrent one about over-diagnosis in mammography screening in these pages, [2] that respondents resort too readily to ad hominem attacks instead of contributing to the argument. Indeed, `the argument` is not always correctly identified: in this case [1] the suitability of the British Chiropractic Association resorting to law in an attempt to silence their critic rather than engaging in open scientific debate. As we can see, both in the libel case itself, and in rapid responses to debates in these pages, an ill chosen word or two can wreak havoc. Cultivating `disinterestedness` (one of the four principles of good science quoted by Fiona Godlee) - when we try not to be influenced by personal feelings in the way we express ourselves - will not only improve the tone of debates, but help drive the caution that is currently necessary in the UK to avoid claims of defamation. [1] Godlee F. Keep libel laws out of science. BMJ 2009; 339:b2783. [2] Jorgensen KJ, Goetzsche PG. Overdiagnosis in publicly organised mammography screening programme: systematic review of screening trends. BMJ 2009; 339:b2587 [3] Marcovitch H. Libel in the law. BMJ 2009; 339:b2759 Competing interests: None declared |
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John Marks, Former Chairman of Council BMA,Retired 62 Eyre Court London NW8 9TU
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The Editor, British Medical Journal Keep libel laws out of science One “Editor’s choice”[1], one editorial[2],, and two articles [3],[4], in one edition of the BMJ demonstrate the importance of this subject. I can empathise with Simon Singh, who is being threatened with a libel case, because I was sued to punish me for telling the truth about a self styled “holistic” doctor whose practice was based on a theory of “Psychic Pain”. Dr Hickey was first arraigned before a misuse of drugs Tribunal in 1987 following the the death of one of his patients through his negligent prescribing of “Diconal”. A year later he was removed from the Register by the General Medical for that and other instances of dangerous practice. An appeal to the Privy Council failed. At that time I was a member of the GMC but had no knowledge of the case. Six years later the BBC made a series of programmes, “Doctors in the dock,” about doctors who claimed they had been wrongly removed from the Register. I was asked to advise the BBC on the complexities of Dr Hickey’s case and agreed to take part in the programme. During the broadcast I made the absolutely true statements that Dr Hickey had “got out of his depth through ignorance”[4] and “he used potentially lethal drugs with no idea of how to handle them”. [5] Two weeks later I received a writ for libel. Dr. Hickey was a wealthy man who could afford to sue me. He did not sue the BBC, two other doctors who made similar remarks on the programme, nor Jean Robinson, a lay member of the GMC who also appeared. He claimed that I alone had been “malicious”. English libel law required that I prove my innocence I was faced with a potentially ruinous bill from lawyers, but fortunately the Medical Protection Society decided to defend me. In June 1995, after a week in court, we won [6]. My intense relief lasted two weeks - Dr. Hickey appealed - but after another two years of anxiety for me he lost again.[7] In his judgement Mr Justice Gray said that what I had said consisted of “defamatory statements of fact”, but they were “substantially justified” and “in the public interest.” These subjective criteria are not those that should be used in the evaluation of scientific evidence. The law of libel, or the threat of it, has no place in that process. John Marks, Former Chairman of Council, BMA. Competing interests nil. 1. Godlee. F. Keep libel laws out of science;BMJ2009;339:b2783 2. Marcovitch. H. Libel law in the UK. BMJ 2009;339:b2759 3. Brow. R. Chiropractors; clarifying the issues. BMJ 2009;338:b2782 4. Edzard. E. Chiropractic for paediatric Conditions. BMJ 2009;339:b2766 5. BBC: Doctors in the dock – a fatal prescription. 7 December 1995 6. Dyer. C. GP looses libel action. BMJ 1999;318(7197);1510 7. Marks. J. The NHS: beginning ,middle, and end? Radcliffe publications:2008. --------------------------------------------------------------------- ----------- Competing interests: none |
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Leslie B Rose, Clinical science consultant Salisbury, SP2 8NJ, UK
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Dr Milgrom's eloquent discourse is marred by several misconceptions, misrepresentations, and misquotations. Rather than address every one of these at tedious length, I will focus on one which has been frequently seized upon by opponents of scientific evidence. Sir Michael Rawlins in his Harveian Oration (1) did not seek to elevate other forms of evidence above the randomised controlled trial. Indeed he was quick to correct widespread misinterpretations of his oration with the following words: “I fully accept that randomised controlled trials have played a major role in 20th century medicine and I expect them to continue to make equally important contributions in the 21st century.” (2) It is interesting that Dr Milgrom proclaims his profession as a homeopath. This is what Sir Michael said on the same occasion: “As far as homeopathy is concerned it breaks every rule in the evidential base! It is biologically implausible; it is almost always used to treat conditions where the natural history is unpredictable; and the signal to noise ratio is close to one!” (2) Perhaps Dr Milgrom was unaware of Sir Michael's position on homeopathy, or was cherry-picking his sources. References: 1.Rawlins M. De Testimonio: Harveian Oration Delivered to the Royal College of Physicians, London 16th October 2008. 2.Rawlins M 2008. Personal communication (with kind permission to quote) Competing interests: None declared |
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Nick Ross, Journalist W2 4XT
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Simon Singh is not the only rational sceptic to be attacked with a libel suit. The whole process of scientific debate - and even peer review - is threatened. See the case of Peter Wilmshurst, a good, honest and diligent critic of poor methodology who is being sued for an assessment that did not fit the vested interests of a company. HealthWatch, the charity which promotes evidence-based medicine, has also been threatened with law suits in the past. Nor can one be confident in the English legal process. I spent part of yesterday at the High Court watching the libel case that ex- pornographer and Daily Express publisher Richard Desmond is bringing against the biographer Tom Bower. Half the evidence was so dull that even court officials, let alone jurists, were struggling to stay awake; the other half was theatrical flourish. There are two defences in libel. The first, of course, is truth. If what scientists write is fundamentally true then there is no defamation. The second-tier of defence follows where there are some factual inaccuracies, but where they do not substantially lower the plaintiff's reputation in the eyes of "right-thinking people" Simon Singh's case, therefore, might come to rest on whether most right-thinking people believe that chiropractic has been riddled with pseudoscience, false assumptions and poor oversight. His lawyers must persuade the jury that his comments on chiropractic would not lower the plaintiff's public reputation, and obviously it would help greatly if anyone who has evidence of bad practice by chiropractitioners would post it on message boards where Simon Singh's legal team can access it to build their case. Competing interests: President, HealthWatch |
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David J Eedy, Consultant Dermatologist Southern Health and Social Care Trust, Portadown, Northern Ireland, BT63 5QQ.
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British Medical Journal, Dear Madam, I refer to the advert in the 11th July 2009 issue of the British Medical Journal for betesil medicated plaster. The advert contains the scene of a consultation between a young lady and a doctor and the caption states “All Joan wanted to hear was that there was a better way, all Dr Brown wanted was to smother her in cream.” This seems totally inappropriate advert for the BMJ to accept for a professional medical journal. This advert did not covey to me a clear and accurate description of what the product was about and I found it offensive that the advert alluded to sexual overtones, which seem to denigrate both the patient and the doctor, and undermines the confidence the public always should have in the inviolability of the professional relationship. Those who have designed this advert have done so presumably to make us remember this product through surprise or inappropriate intrigue rather than imparting product information. It is not about applying a topical agent to heal skin disease or addressing medical issues, but rather presenting patients as a potential object of sexual attraction and this totally inappropriate and unacceptable. Medicine is a moral profession and an advert of this kind is clearly unethical and should immediately be retracted by the journal with an appropriate apology to the readers. David J Eedy
Competing interests: None declared |
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Lionel R Milgrom, scientist, writer, homeopath NW2 3ES
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Mr Rose’s fear of tedium is a singular excuse for responding to my article in such a way that is more concerned with homeopathy - something my article never even mentioned - than the substantive points I was making. So be it. Of course Sir Michael Rawlins would defend the role of RCTs in medicine: why shouldn’t he? As Chair of NICE, not to do so could be seen as a dereliction of his duty. However, that is neither a necessary or sufficient condition for attempting to play down the fact that his Harveian Oration [1] did quite clearly call for the development of ways of assessing evidence in medicine, other than from RCTs: it was also mentioned in media reports of his talk [2]. To suggest on my part misquotation, misconception or misrepresentation is simply wrong; as is his assertion that I am an ‘opponent of scientific evidence’. As for homeopathy’s ‘biological implausibility’, this appears to be the real reason for Mr Rose’s response [3]. Regardless of whether he has the kind permission to quote Sir Michael’s agreement with him on this, it is a patently obvious conclusion derived from a logical positivist mind- set. Implausible however, is not impossible, and while at present there may well be a shortage of pragmatic evidence in this field, it is an area that is constantly developing. Indeed, good evidence is now emerging for the effectiveness of homeopathy in fibromyalgia [4], a condition where conventional medicine has little to offer. In addition, reputable German studies suggest that homeopathy is not only a powerful therapeutic modality for the long-term treatment of chronic conditions [5, 6], it is also extremely cost effective. Perhaps Mr Rose is unaware of homeopathy’s growing evidence base; or that cherry picking is an accusation probably best directed at the 2005 Lancet meta-analysis of homeopathic trials [7}, loudly proclaimed at the time as the ‘death of homeopathy’. A recent re-analysis [8] suggests this is precisely what the authors of the Lancet meta-analysis did. References [1] Rawlins M. De Testimonio: Harveian Oration Delivered to the Royal College of Physicians, London 16th October 2008. [2] See for example, http://www.independent.co.uk/opinion/commentators/michael-rawlins- statistics-can-help-but-doctors-must-also-use-their-judgement-962607.html [3] See, http://www.timesonline.co.uk/tol/life_and_style/health/article1827553.ece [4] Relton C, Smith C, Raw J, Walters C, Adebajo AO, Thomas KJ, Young TA. Healthcare provided by a homeopath as an adjunct to usual care for Fibromyalgia (FMS): results of a pilot randomised controlled trial. Homeopathy. 2009, 98(2):77-82. [5] Witt CM, Lüdtke R, Baur R, Willich SN. Homeopathic treatment of patients with chronic low back pain – a prospective observational study with 2 years follow-up. Clinical Journal of Pain 2009;25(4):334-9. [6] Witt CM, Lüdtke R, Willich SN. Homeopathic treatment of patients with psoriasis – a prospective observational study with 2 years follow-up. Journal of the European Academy of Dermatology and Venereology 2009;23(5):538-43. [7] Shang A, Huwiler-Müntener K, Nartey L, Juni P, Dorig S, Sterne JA, et al. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy Lancet 2005;366:726–32. [8] Ludtke R, Rutten AL. The conclusions on the effectiveness of homeopathy highly depend on the set of analyzed trials. Journal of Clinical Epidemiology. 2008, 61(12):1197-204. Competing interests: None declared |
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Richard Bartley, Physiotherapist Wales
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Having had the good fortune to co-operate with chiropractors in my working life I can testify to their skills and dedication to patients. However, their business model has always been profit-based. In contrast, my profession’s business model is primarily based on public service. This is borne out by business training undertaken at under-graduate level on many chiropractic courses, something completely off the curriculum in physiotherapy training. The chiropractic profession has more to lose than just pride when attacked either fairly or unfairly by commentators. Competing interests: None declared |
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David Colquhoun, Research professor UCL WC1E 6BT
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Thanks for an excellent editorial. I doubt that it's worth replying to Lionel Milgrom whose fantasy physics has been totally demolished by real physicists. Trisha Greenhalgh is, though, someone whose views I'd take very seriously. She raises an interesting question when she says "bogus" is an unprofessional word to use. Two things seem relevant. First, there is little point in writing rational scholarly articles for a group of people who do not seem to accept the ordinary rules of evidence or scholarship. You can point out to your heart's content that "subluxations" are figment of the chiropractors' imagination, but they don't give a damn. Throughout my lifetime, pharmacologists and others have been writing scholarly articles about how homeopathy and other sorts of alternative medicine are bogus. All this effort had little effect. What made the difference was blogs and investigative journalism. When it became possible to reveal leaked teaching materials that taught students that "amethysts emit high yin energy", and name and shame the vice-chancellors who allow that sort of thing to happen (in this case Prof Geoffrey Petts of Westminster University), things started to happen. In the last few years all five "BSc" degrees in homeopathy have closed and that is undoubtedly a consequence of the activities of bloggers and can assess evidence but who work more like investigative journalists. When the BCA released, 15 months after the event, its "plethora of evidence" a semi-organised effort by a group of bloggers produced, in less than 24 hours, thoroughly scholarly analyses of all of them (there is a summary here). As the editorial says, they didn't amount to a hill of beans, They also pointed out the evidence that was omitted by the BCA. The conventional press just followed the bloggers. I find it really rather beautiful that a group of people who have other jobs to do, spent a lot of time doing these analyses, unpaid, in their own time, simply to support Singh, because they believed it is the right thing to do. Simon Singh has analysed the data coolly in his book. But In the case that gave rise to the lawsuit he was writing in a newspaper. It was perfectly clear from the context what 'bogus' meant. but Mr Justice Eady (aided by a disastrous law) chose to ignore entirely the context. The description 'bogus'. as used by Singh, seems to be entirely appropriate for a newspaper article. To criticise him for using "unprofessional" language is inappropriate because we are not dealing with professionals. At least there are some laughs to be had from the whole sorry affair. Prompted by that prince among lawyers known as Jack of Kent there was a new addition to my 'Patients' Guide to Magic Medicine', as featured in the Financial Times. Libel: A very expensive remedy, to be used only when you have no evidence. Appeals to alternative practitioners because truth is irrelevant. Competing interests: None declared |
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Lionel R Milgrom, scientist, writer, homeopath NW2 3ES
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Nick Ross’ expressed lack of confidence in the English legal process and his hope that the resolution of Dr Singh’s case could ultimately depend on what most ‘right-thinking’ people might believe about chiropractic, misses two important points. First, it doesn’t matter whether chiropractic or any CAM are thought to be ‘unscientific’ or to ‘lack evidence’; the point at issue here is that Dr Singh alleged chiropractors promote ‘bogus’ treatments. That this was thought tantamount to accusing them of lying was the reason why he was sued: it has nothing to do with science. If it had, then Fiona Godlee’s point that this is an argument that should be taking place in the pages of academic journals, and not in a court room, is well made. Second, the campaign which arose out of the result of Dr Singh’s case - to ‘keep the libel laws out of science’ – is completely understandable but flawed. For if such a campaign was successful, what might now be considered libellous statements could very well be equated with serious scientific criticism. Under the circumstances, this could lead to the impression however mistaken, that science is like a religion and that those who ply their trade in it consider themselves above the law. This could do great damage to science’s public understanding and reputation at a time when it can ill afford it. Finally; a word of advice to Dr Singh’s legal team. Caution should be exercised in the use of the word ‘pseudo-science’ when describing chiropractic or indeed any CAM. This word has yet to be properly defined within the philosophy of science: indeed, ‘a simple criterion for demarcating science from pseudo-science is unlikely to be found’ [1]. [1] Okasha S. Philosophy of science: a very short introduction. Oxford University Press, 2002, pp13-17. Competing interests: None declared |
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Richard D Rawlins, Consultant Orthopaedic Surgeon Hon Sec South Devon Division, BMA TQ6 0BS
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Given his approach to CAM, would Dr Milgrom then join with me in repeating South Devon (Torquay) Division BMA's call for NICE to review and report on whether homeopathic remedies should be funded by the NHS? I am not concerned whether they 'work' or not, but whether the NHS should fund them. Agreed? Competing interests: None declared |
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Edzard Ernst, Director Complementary Medicine Peninsula Medical School 25 Victoria Park Rd Exeter EX2 4NT UK
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Neil Menzies, the “healthcare analyser” who provided the very first comment in this illuminating exchange, states that I have “for a long time gunned for chiropractic …” He does not provide a single reference to support this accusation. Anyone who cares to read my critique of chiropractic e.g.(1) will, I think, confirm that it uses logic rather than guns. Is it a sign of the irrationality of the debate on chiropractic that critical assessment is now being called “gunning for chiropractic”? Reference List (1) Ernst E. Chiropractic for paediatric conditions. BMJ 2009; 339:79. Competing interests: None declared |
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Austin C Elliott, Lecturer in Physiology University of Manchester M13 9PT
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I have a great deal of respect for Professor Greenhalgh, but I think her comment about Simon Singh's use of the word "bogus" slightly misses the point in at least one respect. It would indeed not be a word one would use in a scientific article - but this was something different, a brief piece in a newspaper.
Apart from anything else, I think one has to see Singh's much-discussed Guardian article in the context of the literally hundreds of newspaper pages devoted annually to uncritical promotion of alternative therapies, mostly in "Health and Lifestyle" sections. For instance, a couple of years ago my local newspaper ran an article headed "Alternative cures for autism" which reported the use of chiropractic on a severely autistic boy. The chiropractor treating the autistic child was quoted as stating: "I treated [his] spine for mechanical problems, which we could be certain would benefit his health" (italics mine). The same newspaper has latterly had a regular health column where a homeopath can be found enthusiastically recommending things like cranial osteopathy for childhood asthma, and homeopathy for practically everything. None of this typically appears with any meaningful kind of counterbalancing voice.
Against this kind of background, one might suggest that saying "the BCA promote therapies for which the clinical trial evidence is very weak" is simply not "pungent" enough to get the message across to the target audience of newspaper readers.
Back in the professional arena, it is laudable that we have proper attempts to get to the bottom of which CAM interventions have real effects. (Professor Ernst's work has been outstanding in this context, making the repeated digs at him by CAM advocates like Lionel Milgrom all the more snide and unworthy.) However, the CAM advocates have to play by the same rules as the rest of science and medicine. To me this would include accepting:
(i) that underlying "biological plausibility" is a real issue, and that this ought to be used to inform the overall verdict extrapolated from the (usually sparse) evidence from trials on CAM;
(ii) that there is a real ever-present possibility - or even likelihood - that much of CAM represents placebo therapy; and
(iii) that in science and medicine, better-quality evidence "outranks" worse-quality evidence, even if it disagrees with your cherished beliefs.
I have to say that from where I am standing the evidence that the CAM enthusiasts are doing this is, to put it mildly, sparse. Manchester Evening News online edition on Aug 17th 2007: Alternative cures for autism. Carmel Thomason http://www.manchestereveningnews.co.uk/lifestyle/health_and _beauty/health_and_beauty_feature/s/1013/1013378_ alternative_cures_for_autism.html Competing interests: None declared |
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Joan McClusky, Medical writer New York, NY 10003
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Most of the people I know who use complementary medicine do so for a couple of reasons, but one of the most important is their dislike of physicians. And this is cultural as much as anything else. The notion that a person with years of education and training might have a leg up on someone without these attributes--at least in the area of expertise--is viewed as some sort of undesirable "elitism." Kurt Vonnegut's 1961 short story "Harrison Bergeron" (part of "Welcome to the Monkey House") captures this well--and was also prescient of the way society was headed. Anyone more athletic, beautiful, or intelligent than average has to be handicapped to the lowest common level. Harrison has to carry extra weight, disguise his good looks, and wear noisy earphones. He meets a similarly disguised ballerina, they both disgard their leveling accoutrements, and dance together. They are both shot dead by the Handicapper General. Modern medicine--and practitioners--appear to under the gun of numerous self-appointed Handicapper Generals. And one way they continue to stay in power is by dismissing science, and scientific evidence. Competing interests: None declared |
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Simon Carley, Professor of Emergency Care Manchester, M13 9WL, Bernard Foex
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The Editor, British Medical Journal. The Simon Singh case raises concerns for many of us who aspire to practice on the basis of ‘evidence’. BestBETs (1) (Best Evidence Topics) is an online repository of over 1500 evidence based reviews that has always advocated debate and discussion across all aspects health care, alternative and conventional alike. Indeed, BestBETs has published articles on many alternative therapies including acupuncture, chiropractic, osteopathy and homeopathy. Selected BETs are subsequently published in the Emergency Medicine Journal, Archives of Disease in Childhood and the Interactive Cardiovascular and Thoracic Surgery journals. Indeed, BestBETs and Archives of Diseases in Childhood have published a review on the use of chiropractic for infantile colic (2). Our approach is designed to encourage and empower clinicians to search, appraise and debate the evidence for all aspects of healthcare. The prospect that such a debate might be restricted by the threat of libel is terrifying. Our strategy in supporting clinicians by sharing their interpretation of evidence is strengthened through argument and debate. Whilst our approach has been controversial at times, even from within the clinical community (3), we have always seen such controversy as a strength and certainly not something that should be feared. It has been argued that Simon Singh has found himself in trouble because of the language used. Terms such as ‘bogus’ would not typically pass the editorial controls of scientific websites or journals. However, the underlying principle is that any assertion in relation to healthcare can, and should be, challenged. History has shown that patients ultimately benefit when both established and novel treatments are put to the test and debated freely by the clinical community. If that is in any way impeded by the imposition of libel laws then it is not just clinicians and journalists who will suffer, it will be our patients. Simon Carley
Bernard A Foëx
1. http://www.bestbets.org 2. Archives of Disease in Childhood 2002;86:382-384 3. http://emj.bmj.com/cgi/content/abstract/22/12/887-a Competing interests: None declared |
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Leslie B Rose, Clinical Science Consultant Salisbury, UK, SP2 8NJ
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I will resist the temptation to discuss homeopathy further with Dr Milgrom in this discussion thread, but assure him that I am more than willing to do so elsewhere. My purpose was not to divert the discussion away from chiropractic, but to provide context for his appeal to authority by citing Sir Michael Rawlins. I wonder if Dr Milgrom has actually read Sir Michael's Oration? I am particularly drawn to Dr Milgrom's suggestion that Sir Michael argued for the use of evidence `other than' RCTs. If `other than' means as an alternative, this is not true. The oration made the important point that RCTs have limitations, some methodological, and they sometimes have limited generalisability. Supporters of evidence based medicine do not deny this. Therefore the recruitment of lower grade evidence can be helpful when making clinical decisions. The problem with chiropractic and virtually all other forms of CAM is that they mostly lack the bedrock of RCT evidence, and no amount of intellectual Polyfilla is going to fill the gaps. I am astonished that Dr Milgrom should appeal to the authority of the lay media. The Oration was very widely misinterpreted, even by the BBC. A bit ironic, when the subject of all these responses is the use of words describing science in the lay media. Competing interests: None declared |
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Lionel R Milgrom, scientist, writer, homeopath NW2 3ES
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I am no lawyer and presumably neither is Mr Rawlins, but conflating law and metaphysics in order to suggest negative trials published in the peer reviewed literature could be considered defamatory is just a little extreme, and no-one is suggesting it. Mr Rawlins then issues an interesting challenge. I preface my response with the following:- a. Total NHS spending on ALL homeopathic prescriptions in 2007 = £321,000. b. Total drug spend by ONE NHS hospital in NW London in 2007 = £86,000,000. Combine this with the previously-mentioned emerging evidence of homeopathy’s therapeutic and cost effectiveness in the treatment of chronic long-term chronic conditions (e.g., fibromyalgia [1]), and it would be nice were NICE to conclude that NHS funding of homeopathic remedies is excellent value for money and should continue. As with acupuncture for lower back-pain, it is not inconceivable that NICE could recommend this to the NHS but as Mr Rawlins well knows, it is PCTs which determine how money is spent, and this feeds into the more general problem of patchy local provision of therapies/procedures (Mr Rose and his colleagues might wish to take credit for PCT decline homeopathy provision, but it had started well before their letter to the Times [2]). So I wish Mr Rawlins good luck in repeating his South Devon BMA chapter’s call to NICE, but I will not be joining him. I also thank Mr Rose for his encouraging comments about the shortcomings of RCTs, and can assure him that not only have I have read Sir Michael Rawlins’ Harveian Oration, but that my use of the word ‘other’ in the context of forms of evidence means complementary, not alternative. In many respects, Sir Michael was echoing the original definition of Evidence-Based Medicine as ‘….an approach to health care that promotes the collection, interpretation, and integration of…. patient-reported, clinician-observed, and research-derived evidence. The best available evidence, moderated by patient circumstances and preferences, is applied to improve the quality of clinical judgments.’ [3], a view suggesting that within EBM, the RCT was originally envisaged as part of an evidence ‘package’ derived from multiple sources. Indeed, David Sackett (one of EBM’s founders) later went further, ‘Evidence-based medicine is not restricted to randomised trials and meta- analyses. It involves tracking down the best external evidence with which to answer our clinical questions.....if no randomised trial has been carried out for our patient’s predicament, we follow the trail to the next best external evidence and work from there’ [4]. This suggests that as far back as 1996, Sackett was concerned EBM might be in danger of turning into an evidence ‘mono-culture’, where the primacy of an ‘ideal’ scientifically-determined efficacy would subsume other no less important forms of evidence, to the possible detriment of patient and clinician concerns. Mr Rose’s use of the terms ‘bedrock’ and ‘lower grade’ to describe respectively RCT and ‘other’ forms of evidence, it could be argued is the extent to which Sackett’s concerns have been realised. Indeed, ten years later, voices were raised within the nursing profession concerning EBM’s intolerance of therapeutic pluralism in healthcare systems [5]. As with everything, ‘It begins with a blessing, and ends with a curse….’ [6]. References 1. Relton C, Smith C, Raw J, et al. Healthcare provided by a homeopath as an adjunct to usual care for Fibromyalgia (FMS): results of a pilot randomised controlled trial. Homeopathy. 2009, 98(2):77-82. 2. Baum M, Ashcroft F, Berry C, et al. Use of “Alternative Medicine” in the NHS. The Times, May 19, 2006. 3. McKibbon, KA, Wilczynski N, Hayward RS, et al. The medical literature as a resource for evidence based care. Working paper from the Health Information Research Unit, McMaster University, Ontario, Canada, 1995. http://hiru.mcmaster.ca/hiru/medline/asis-pap.htm. 4. Sackett, DL., Rosenberg WMC, Muir Gray JA, et al. (1996) Evidence based medicine: what it is and what it isn't. BMJ 1996; 312 (7023): 71-2. 5. Holmes D, Murray SJ, Perron A, Rail G. Deconstructing the evidence- based discourse in health sciences: Truth, power, and fascism. International Journal of Evidence Based Healthcare 2006;4:180. 6. ‘Why are we sleeping?’, Lyrics by Kevin Ayres, The Soft Machine ca 1968. Competing interests: None declared |
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Simon J Baker, Veterinary Surgeon House & Jackson Veterinary Surgeons, Blackmore, Essex, CM4 0LE
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In his enthusiastic espousal of Sir Michael Rawlins' idea that EBM should be more open to forms of evidence other than RCTs, Lionel Milgrom seems to have missed the fundamental qualification made by Rawlins in advocating the use of the "totality of the available evidence". Rawlins said, "other ways to establish the benefits of an intervention" are applicable "where the effects are substantial and ‘dramatic’", which is not true of any CAM therapy. Ironically for Dr Milgrom, Rawlins criticises the frequentist approach to statistical analysis in RCTs, but that weakness is especially true of those RCTs performed on CAM therapies, which we often see touted in various media. I think that we can safely say that the Reverend Bayes' methods and the involvement of prior probability in the analysis of trial data would be even more damning of CAM. I think many would argue that it is only by a narrowly inappropriate application of frequentist methods that CAM advocates ever manage to trawl together enough evidence to fill their web pages: run 20 tests at p=0.05 and publicise the one that was 'positive'. Rawlins is careful to review the idea of "hierarchies of evidence", but his arguments should not be turned into an excuse to use only the weakest forms of evidence and, very particularly, they are not an excuse to ignore high-quality evidence if it is available. Dr Milgrom appears to skate around the unavoidable and, presumably for him, uncomfortable implication, that, when high-quality evidence contradicts low-quality evidence, it is the high-quality evidence that has the veto and practitioners of every therapy should aspire to obtain evidence that is as high-quality as possible. Does he agree with Professor Ernst that the BCA's "plethora" omitted some important and high-quality evidence when it was placed in the public domain? Is it my imagination or do the advocates of CAM appear to dig through all the good apples sitting at the top of the barrel in order to find the bottom and give it a good scrape looking for what they really wanted? Competing interests: None declared |
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Noel B Thomas, Semi retired NHS GP, homeopath(NHS only ) Bron y Garn, Maesteg, Wales CF34 9AL
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A sensible editorial, penned by female hand, has been followed by a stream of male responses. A few have taken little notice of Hazel Thornton’s contribution. Hers is one of only three, calm, female responses. It is said that John F Kennedy had a framed quotation in the Oval Office, “Always try to put yourself in your opponent’s position. Avoid self righteousness like the devil.” A sentiment that may have helped to avoid nuclear war during the Cuban missile crisis, but is of little interest to men of stature nowadays. The BCA may in time regret its mistaken recourse to the Court, the recent judgement in its favour notwithstanding. In the rush to attempt reversal of that judgement, it might be sensible to open our minds a little, and see the issues in a wider context. Acknowledging, for a start, that material in peer reviewed journals is not necessarily our rock and our ammunition. Readers of The New York Review of Books (1) will have been surprised to read the recent comments of Marcia Angell, “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgement of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as editor of The New England Journal of Medicine.” (1) Angell, M. ,The New York Review of Books, Volume LV1, Number 1 Yours sincerely Competing interests: None declared |
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Lionel R Milgrom, scientist, writer, homeopath NW2 3ES
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It could be my imagination but when it comes to discussing the evidence for CAM, is there among some of the contributors to this thread, an increasing pre-occupation with fruit (e.g., cherry picking, scraping the apple barrel etc)? If so, then unfortunately Simon Baker is on very shaky ground indeed. The 2005 Lancet meta-analysis [1] which sceptics of homeopathy continuously refer to as evidence that homeopathy is no better than placebo, has been shown quite conclusively to be a prime example [2, 3] of the data 'cherry-picking' Simon Bates and others seem to be suggesting CAM advocates indulge in. Indeed, if he were to check, he would find that meta -analysis was in clear breach of the Lancet's very own stringent guidelines on methodological and publication transparency [4], leading one to seriously question why it ever appeared in such an eminent journal in the first place. As for scraping the barrel, perhaps Simon Bates could explain why sceptics of CAM seem to ignore their own perfectly good apples. I refer to the trial of one of the world's top-selling drugs, the antidepressant Prozac, which was found to be no better than placebo [5]. With an effect size of only d ~ 0.3 (by the way, NICE recommends a minimum of d = 0.5 for the 'Michelin Star' of clinical efficacy), would Simon Bates agree that urgent calls should go out for Prozac's immediate withdrawal through 'lack of efficacy'? Of course he wouldn't. With regard to his faith in the RCT as the strongest form of evidence, Simon Bates seems to be guilty of the very thing Sir Michael Rawlins was warning against in his Harveian Oration, i.e., "RCTs, long regarded as the 'gold standard' of evidence, have been put on an undeserved pedestal. Their appearance at the top of hierarchies of evidence is inappropriate; and hierarchies are illusory tools for assessing evidence. They should be replaced by a diversity of approaches that involve analysing the totality of the evidence base." [6] References 1. Shang A, Huwiler-Muntener K, Nartey L, Juni P, Dorig S, Sterne JA, et al. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy Lancet 2005;366:726-32: 2. Ludtke R and Rutten ALB. The conclusions on the effectiveness of homeopathy highly depend on the set of analyzed trials. Journal of Clinical Epidemiology 2008;61(12):1197-1204: 3. Chaplin M. Water structure and behaviour; regularly updated online document at www.lsbu.ac.uk/water/: 4. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta- analyses Lancet 1999;354:1896-900: 5. Kirsch I, Deacon BJ, Huendo-Medina T, Scoboria A, Moore TJ, Johnson BT. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PloS Med 2008;5(2): e45: 6. Rawlins M. De Testimonio: On the evidence for decisions about the use of therapeutic interventions.The Harveian Oration, delivered before the Royal College of Physicians of London, 16th October 2008, ISBN 978-1-86016-3470. Competing interests: None declared |
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Stephen F Hayes, GP, GOwSI in dermatology 66A Portsmouth road, Southamoton, SO19 9HJ
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Long term readers of Private Eye magazine, which as well as poking fun (sometimes unkindly) at various targets has broken several important stories, including the Bristol heart surgery scandal, was almost closed down by a libel award for £250,000 won by the late Robert Maxwell. I was one of the many readers who sent a tenner to stop the Eye's closure. Later, it turned out that Maxwell, as well as his other disagreeable qualities, had been stealing his employees pensions funds on a truly massive scale. He slapped libel writs on many journalists, apparrently to scare them off from. The English libel laws helped conceal his nefarious and illegal activities by terrorising investigative journalists. I was astounded when the libel laws remained intact after all this came to light. Britain is in dire need of a constitutional right to free speech with precious few limits. Competing interests: None declared |
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Leslie B Rose, Clinical Science Consultant Salisbury, UK, SP2 8NJ
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I should apologise to Dr Milgrom for not replying to his contributions at comparable length. I simply don't have the time. But I am grateful to him for helping me to focus on one of his points which seems unclear. If Sackett said "if no randomised trial has been carried out for our patient’s predicament, we follow the trail to the next best external evidence and work from there" (1), how does this apply to the present debate? The problem with the claims of the British Chiropractic Association is that, according to Ernst (2), RCTs have been carried out, but are either of execrable quality or showed no effect and were ignored by the BCA. The supporteers of CAM continually wail that research hasn't been carried out on their treatments. This is not true of chiropractic (neither is it true of homeopathy which has been researched almost literally to death). Sackett's point is, what do you do when RCT evidence isn't there? He was not saying "Well if RCTs have been carried out and the evidence is weak or negative it's perfectly OK to use other evidence". I am worried that debates like this often gravitate into fusillades of appeals to authority, as if an authority cited is 100% correct. We do not need to follow slavishly the dictats of charismatic individuals, but rather should take note of their wisdom and reach balanced conclusions. References 1. Sackett, DL., Rosenberg WMC, Muir Gray JA, et al. (1996) Evidence based medicine: what it is and what it isn't. BMJ 1996; 312 (7023): 71-2. 2. Ernst, E. (2009) Chiropractic for paediatric conditions: substantial evidence? BMJ 2009;339:b2766. Competing interests: None declared |
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Edzard Ernst, Director of Complementary Medicine Peninsula Medical School, Universities of Exeter & Plymouth, 25 Victoria Park Road, Exeter, EX2 4NT.
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L.R. Milgrom does not like cherry picking? Neither do I. That’s why, some years ago, I summarized all the systematic reviews/meta-analysis of homeopathy 1. At the time, there were 17 articles that fulfilled the inclusion criteria. Collectively, they did not provide strong evidence in favour of homeopathy. My conclusion was that “the best clinical evidence for homeopathy available to date does not warrant positive recommendations for its use in clinical practice” 1. Meanwhile, homeopaths produced “an overview of positive homeopathy research” 2 – and guess what? Its conclusion was positive! I do wonder who does the cherry picking. Reference List (1) Ernst E. A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol 2002; 54:577-582. (2) European Network of Homeopathy Researchers. An overview of positive homeopathy research and surveys. ENHR 2007; March:1-21. Competing interests: None declared |
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Lionel R Milgrom, scientist, writer, homeopath NW2 3ES
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I thank Mr Rose for his gracious apology and am glad that my previous response has helped him focus. In turn, I offer my own apology for imposing on his time to reply at length and with appeals to ‘authority’. Old habits unfortunately, die hard. Mr Rose’s complaint that supporters of CAM ‘continually wail’ not enough research has been done is somewhat egregious, as many of them are actually hard at work, uncomplainingly investigating CAM, and in a research environment that is generally less well financed than most. The only wailing to be heard is from various contributors to this and earlier threads demanding a halt to further CAM research because of the presumption that in many cases, ‘it shouldn’t work, therefore it cannot work’. This is especially so with homeopathy, and it might interest Mr Rose to know that far from being ‘researched almost literally to death’, it is actually very much alive. Not only is there growing evidence of homeopathy’s therapeutic [1] and cost effectiveness [2, 3] (e.g., in the treatment of long-term chronic conditions such as fibromyalgia), but over 500 clinical studies of homeopathy and over 1000 trials in biological and physical systems have been performed world-wide of which around 60% show evidence of efficacy [4]. Concerning RCTs - a technique by the way, which was first pioneered by homeopaths as far back as the 1830’s [5] - of 134 published, 59 (44%) were positive (i.e., showed an effect beyond placebo); 67 (50%) were either inconclusive or showed a small positive effect; while 8 (6%) were negative. Of 23 systemic reviews published 10 have shown an overall positive effect for homeopathy; 8 were inconclusive and 5 showed little or no evidence of efficacy [6]. The odds here are generally in favour of homeopathy’s efficacy, but perhaps Mr Rose was correct when in an earlier response, he pointed out that RCTs have their limitations; an observation made rather more forcefully by Smith and Pell in the conclusion to their paper on the use of parachutes to prevent death by falling: ‘As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials. Advocates of EBM have criticised the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of EBM organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute [7]. The points Mr Rose makes about Sackett’s statement suggest our differences here could well hinge on how one interprets ‘….following the trail to the next best external evidence and working from there’. This depends on the emphasis placed on the statement’s previous clause ‘if no RCT has been carried out for our patient’s predicament….’ [8]. Mr Rose chooses to emphasise RCTs, but what about the phrase ‘our patient’s predicament’? For what Sackett in a recondite way is saying (and which has been pointed out previously in this thread) is that doctors, therapies, even RCTs and Evidence-based Medicine (EBM) exist for the benefit of patients and not the other way around. No doubt Mr Rose would agree with this and might even think that I am unnecessarily splitting hairs. But as Sackett was implying, the RCT was originally intended as part of an evidence package within EBM that could include patient-reported, and clinician observed evidence [9]. The elevation of the RCT to an exclusively worshipped ‘golden calf’ of evidence goes against the first part of what Sackett was saying and that Mr Rose left out, ‘Evidence-based medicine is not restricted to randomised trials and meta- analyses. It involves tracking down the best external evidence with which to answer our clinical questions.....’, something that chimes with the thrust of Sir Michael Rawlins’ Harveian oration [10]. So, we should ask ourselves: are we trying to answer clinical questions for the benefit of our patient’s predicament, or are we serving a scientific (perhaps even scientistic? [11]) ‘ideal’ of what some think medicine ought to be? From this perspective, one can perhaps detect a note of compassion in Sackett’s original formulation of EBM that now seems sadly lacking in those who insist RCTs are the only acceptable form of evidence of efficacy. Finally, I agree wholeheartedly with Mr Rose that we should not follow the dictats of charismatic individuals, nor are authorities to whom one might appeal necessarily 100% correct. Dr Noel B Thomas’s quote from Marcia Angell, the ex-editor of the New England Journal of Medicine about her lack of belief in published clinical research provides a sobering reminder of that [12]. And as the Enlightenment empirical philosopher John Locke pointed out 320 years earlier, ‘For where is the man that has uncontestable evidence of the truth of all that he holds, or of the falsehood of all he condemns; or can say that he has examined to the bottom all his own or other men’s opinions? The necessity of believing without knowledge, nay often upon very slight grounds, in this fleeting state of action and blindness we are in should make us more busy and careful to inform ourselves than to restrain others….There is reason to think that if men better instructed themselves, they would be less imposing on others’ [13]; a suggestion that perhaps those who might wish to ‘enforce’ RCTs on medicine [14] as the sole arbiter of a modality’s efficacy – something which could ultimately deny patients their right of therapeutic choice within the NHS - might usefully meditate upon. References 1. Relton C, Smith C, Raw J, et al. Healthcare provided by a homeopath as an adjunct to usual care for Fibromyalgia (FMS): results of a pilot randomised controlled trial. Homeopathy. 2009, 98(2):77-82: 2. Witt CM, Lüdtke R, Baur R, Willich SN. Homeopathic treatment of patients with chronic low back pain – a prospective observational study with 2 years follow-up. Clinical Journal of Pain 2009;25(4):334-9: 3. Witt CM, Lüdtke R, Willich SN. Homeopathic treatment of patients with psoriasis – a prospective observational study with 2 years follow-up. Journal of the European Academy of Dermatology and Venereology 2009;23(5):538-43: 4. van Wijk R, Albrecht H. Proving and therapeutic experiments in the HomBRex basic homeopathy research database. Homeopathy 2007;96:252–257: 5. Kaptchuk T (2004). Early use of blind assessment in a homoeopathic scientific experiment. The James Lind Library, www.jameslindlibrary.org: 6. See, www.anhcampaign.org/practitioners/homeopathy: 7. Smith GCS and Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of RCTs. BMJ 2003;327:1459- 1451: 8. Sackett, DL., Rosenberg WMC, Muir Gray JA, et al. (1996) Evidence based medicine: what it is and what it isn't. BMJ 1996; 312 (7023): 71-2.: 9. McKibbon, KA, Wilczynski N, Hayward RS, et al. The medical literature as a resource for evidence based care. Working paper from the Health Information Research Unit, McMaster University, Ontario, Canada, 1995: 10. Rawlins M. De Testimonio: On the evidence for decisions about the use of therapeutic interventions.The Harveian Oration, delivered before the Royal College of Physicians of London, 16th October 2008, ISBN 978-1-86016-3470: 11. Okasha S. Philosophy of science: a very short introduction. Oxford University Press, 2002, pp13-17: 12. Angell, M. ,The New York Review of Books, Volume LV1, Number 1; January 15th, 2009: 13. Locke J. Essay concerning human understanding, edited with an introduction by Nidditch PH, Oxford University Press (paperback) 1979: 14. Holmes D, Murray SJ, Perron A, Rail G. Deconstructing the evidence- based discourse in health sciences: Truth, power, and fascism. International Journal of Evidence Based Healthcare 2006;4:180. Competing interests: None declared |
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Richard D Rawlins, Consultant Orthopaedic Surgeon TQ6 0BS
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As part of the general debate about libel I earlier commented that the BMA is calling on NICE to review and report on whether homeopathic remedies should be funded by the NHS. On 18th July Dr L. Milgrom states he notes this call but will not be joining in. Why not? Surely he agrees with me that access to homeopathic remedies by NHS patients is patchy and very much a 'post-code lottery' as to whether patients who wish to have homeopathic remedies are funded by their PCT. Is that not to be deprecated? Given the current expenditure on homeopathy by the NHS, (as pointed out by Dr Milgrom), is it not time that NICE gave a considered opinion as to whether the NHS should fund these remedies? Failure to support such a reasonable action by NICE might open up concerns that Singh could have a point, and this could weaken the BCA's position in the ongoing legal action. Competing interests: These discussions are about CAM and libel. I have interests in honesty in healthcare, and the application of science rather than semantics. This may conflict with the approaches taken by some others in these pages. |
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Lionel R Milgrom, scientist, writer, homeopath NW2 3ES
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Mr Rawllins (oddly) lists as competing interests, ‘honesty in healthcare and the application of science rather than semantics.’ Prof Ernst wonders ‘who does the cherry picking’. Very well. In the August issue of Prospect [1], writer and broadcaster John Naish exposes the horrendous scale of endemic, systematic fraud that occurs in medical and pharmacological research [2]. Apparently, this is not an unknown phenomenon. The prestigious journal Nature, so Naish tells us, reported in 2008 that ‘in the US around 1000 incidents of suspected fabrication, falsification, and plagiarism go unreported every year’ [3]. In the UK, the Committee on Publication Ethics estimates that there are about 50 cases per year of serious fraud in biomedical research. Alarmingly, Naish continues, it appears academia tries to cover up this abuse of science. He concludes, ‘We may have to wait for fresh scandals before anyone acts. Until then, patients will remain in real danger of taking expensive drugs whose risk of harm or inability to cure, have been fraudulently suppressed.’ Given the vast billions spent annually marketing the pharmaceutical industry’s products, and the clear evidence of existing harm perpetrated by conventional medical practice both in the UK [4] and elsewhere [5], one wonders why so much energy is expended trying to demonstrate CAMs and those who practice them, are ‘unproven, unscientific, deadly and dangerous’. Honesty in healthcare? Mr Rawlins could perhaps begin thumping the tub for full disclosure of biomedical misdemeanours. Cherry picking? Perhaps Profs Ernst, Colqhoun, and Dr Singh might usefully employ their undoubted talents campaigning to expose mendacity and lack of professionalism within their own backyard. After all, to avoid further tarnishing science’s already damaged reputation in the mind of the public, would it not be wise for those militating to ‘keep the libel laws out of science’ [6] to carefully consider their campaign cuts both ways? References 1. Naish J. Faking it. Prospect, August 2009, p63: 2. Fanelli D How Many Scientists Fabricate and Falsify Research? A Systematic Review and Meta- Analysis of Survey Data. PLoS ONE 2009;4(5):e5738. doi:10.1371/journal.pone.0005738: 3. Titus SL, Wells AJ, Rhoades LJ. Repairing research integrity. Nature 453, 980-982 (19 June 2008) | doi:10.1038/453980a: 4. Leigh E. A safer place for patients: Learning to improve patient safety. 51st report of session 2005–06 report, together with formal minutes, oral, and written evidence. House of Commons papers 831 2005–06, TSO (The Stationery Office). July 6, 2006: 5. See, http://www.health-care-reform.net/causedeath.htm: 6. Godlee F. Keep the libel laws out of science. BMJ 2009;339:b2783. Competing interests: None declared |
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William Alderson, Homeopath Poppyseed Cottage PE33 9SF
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Edzard Ernst does not like cherry-picking, he claims. He does have other predilections when it comes to research, however. For example, his standards of "rigour" include using a non- existent trial (unreferenced), which turns out to be two trials he has conflated. (1,2,3) His standards of "authority" include using an unreferenced study of gullibility which did not meet any of the standards he considers indispensable in the case of a trial of homeopathy. (4) His standards of "independence" include using an unreferenced "1999 survey of British newspapers by Professor Edzard Ernst”, in which he “sampled four broadsheet newspapers on eight separate days”, yet was somehow unable to provide the criteria for selecting these days and newspapers. (5,6) Even now he has provided references online to only the first two examples, so his own research is still unverifiable. What these examples have in common is the fact that they supported his views, views which he maintained offered "an unparalleled level of rigour, authority and independence”. (7) If these examples represent his standards, and the rest of his book on alternative medicine does nothing to undermine such a view, then any conclusions he may draw from his investigations into the research of others has little credibility, and any criticism he may offer of other researchers is laughable. William Alderson RSHom (1) William Alderson, Halloween Science: The truth about Trick or Treatment? by Simon Singh and Edzard Ernst (Stoke Ferry: Homeopathy: Medicine for the 21st Century, 2009), pp. 106-107, available at <http://www.hmc21.org>. (2) Simon Singh and Edzard Ernst, Trick or Treatment? Alternative medicine on trial (London: Bantam Press, 2008), p. 265. (3) Missing references for Trick or Treatment? for 'Page 320' supplied at <http://www.trickortreatment.com/references_6.html>. (4) Missing references for Trick or Treatment? for 'Page 323' supplied at <http://www.trickortreatment.com/references_6.html>. (5) Alderson, 2009, p. 106. (6) Singh and Ernst, 2008, p. 265. (7) Singh and Ernst, 2008, p. 3. Competing interests: None declared |
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William Alderson, Homeopath Poppyseed Cottage PE33 9SF
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Austin C Elliott distinguishes between “science and medicine” in his contribution to this debate, an important distinction in the context of the libel case. If Simon Singh had only ‘generally accepted medical evidence’ rather than ‘scientific evidence’ to support his claim, he faces trial not for holding scientific views but for promoting unfounded opinions. Elliott reinforces the division between science and medicine with his list of rules, which need addressing in some detail: (i) “Biological plausibility” may be “a real issue”, but only for those who are convinced that their body of knowledge is unchallengeable, which often seems to be case with opponents of CAM. For the rest of us it is not a scientific term, but an acknowledgement of ignorance, since it is a statement that current knowledge does not have an explanation for what has been allegedly observed. Inexplicable observations are not irrelevant nonsense but the starting point of scientific investigation, and when such observations which have been made systematically over hundreds of years (as is the case for homeopathy), open-minded investigation is a scientific necessity. (ii) That “much of CAM represents placebo therapy” is another interesting position which distiguishes medicine from science. Edzard Ernst, whose “work has been outstanding” (according to Elliott) notes that “scientists strive to establish the scientific basis of the placebo effect”. (1) To base criticism of CAM on an effect without a scientifically established mechanism of action is unscientific, especially if your criticism of CAM includes claims that its mechanism of action is “implausible”. In fact the mechanism of action for homeopathy (for example) is better developed than that of the placebo effect, is based on the use of the scientific method, and incorporated germ theory, evolution and the need for medical and public hygiene from 30 to 100 years before “modern” medicine. (2,3) (iii) When it comes to supporting “better-quality evidence”, it is essential to provide a standard for measuring the quality. Elliott, like Ernst (and Singh), makes the assumption that RCTs are better than clinical obvservation, but Ernst himself points out that “there was still no guarantee that a treatment that had succeeded during a set of trials would cure a particular patient”. (4) Clearly RCTs are not “better-quality evidence” but only an incomplete part of the necessary totality of evidence, the position of proponents of EBM. (5) The problem is not with the RCT, which is an extremely good scientific tool, but with those who seem to think that it produces ‘truth’ in the abstract because that ‘truth’ accords with “their cherished beliefs” (as Elliott puts it). If your definitions of effectiveness and of what you are treating are not scientifically valid, then the result of any trial based on those definitions will be useless. Ernst and Singh (“both trained scientists”) note this (6), but fail to provide the necessary definitions in their extensive, but therefore useless, study of alternative medicine. (7) Simon Singh stated that he based his remarks about the BCA on this study, (8) so he does indeed face trial not for holding scientific views but for promoting unfounded opinions. (1) Simon Singh and Edzard Ernst, Trick or Treatment? Alternative medicine on trial (London: Bantam Press, 2008), p. 62. (2) William Alderson, Halloween Science: The Truth about Trick or Treatment? by Simon Singh and Edzard Ernst (Stoke Ferry: Homeopathy: Medicine for the 21st Century, 2009), pp. 38-45. (3) Samuel Hahnemann (trans. William Boericke MD), The Organon of Medicine, 6th edn, finished in 1842 (Calcutta: Roy Publishing House, repr. edn 1972), § 81 p. 160. (4) Singh and Ernst, 2008, p. 23. (5) Sackett, David L, William M C Rosenberg, J A Muir Gray, R Brian Haynes, W Scott Richardson, ‘Evidence based medicine: what it is and what it isn't’, BMJ, 312 (1996), 71-72 (13 January). (6) Singh and Ernst, 2008, p. 3. (7) Alderson, 2009, p. 127. (8) Simon Singh, ‘Beware the spinal trap’, The Guardian, 19 April 2008. Competing interests: None declared |
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Richard Rawlins, Consultant Orethopaedic Surgeon TQ6 0BS
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Dr Milgrom might be right about flaws in much published literature, the work of some researchers and difficulties in obtaining scientifically credible evidence, but I have not raised those issues. I simply want him to join with me (and South Devon Division, BMA) in urging NICE to review the considerable literature on the benefits of homeopathy, to which Dr Milgrom refers, and to decide whether those benefits are of sufficient value to be worthy of funding by the NHS. Surely that would assist all practitioners who have to help patients decide about treatments, and the patients themselves? Easy. Will Dr Milgrom confirm he supports such a review by NICE? His support, which must be for the benefit of patients, would be appreciated. Thank you. Competing interests: None declared |
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Petter Viksveen, ENHR Coordinator 4008 Stavanger, Viksveen Petter
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On 21 July Ernst referred to “cherry picking” and stated that “homeopaths produced “an overview of positive homeopathy research” – and guess what? Its conclusion was positive! I do wonder who does the cherry picking.” Ernst refers to a document developed by the European Network of Homeopathy Researchers (ENHR) (1) when discussing systematic reviews/meta- analysis of homeopathy. The ENHR document clearly states in the introduction that it "contains a sample of brief summaries of positive homeopathy research". Hence, this document does NOT claim to provide a systematic review or meta-analysis, and it is unclear why Ernst would refer to it in this context. What Ernst COULD have referred to is eight literature reviews and meta-anslysis (2-9) which DID conclude in favour of homeopathy in one way or another. Reference list 1. European Network of Homeopathy Researchers. An overview of positive homeopathy research and surveys. ENHR 2007; March:1-21. 2. Jonas, W. B., Kaptchuk, T. J., & Linde, K. 2003b, "A critical overview of homeopathy", Ann.Intern.Med., vol. 138, no. 5, pp. 393-399. 3. Cucherat, M., Haugh, M. C., Gooch, M., & Boissel, J. P. 2000, "Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic Medicines Research Advisory Group", Eur.J.Clin.Pharmacol., vol.. 56, no. 1, pp. 27-33. 4. Mathie, R. The research evidence base for homeopathy: a fresh assessment of the literature. Homeopathy 92: 84-91. 2003. 5. Linde K, Clausius N, Ramirez G, et al. Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 1997;350:834-43. 6. Report to the European Commission directorate general XII: science, research and development. Vol 1. Brussels: European Commission, 1996:16-7. 7. Kleijnen J, Knipschild P, Ter Riet G. Clinical trials of homoeopathy. British Medical Journal. 1991b;302:316-23. 8. Linde K. Jonas WB, Melchart D, Worku F, Wagner H, Eital F. Critical Review and Meta-Analysis of Serial Agitated Dilutions in Experimental Toxicology. Human and Experimental Toxicology. 1994;13:481- 492. 9. Reilly D, Taylor MA, Beattie NGM, Campbell JH, McSharry C, Aitchison TC, Carter R, Stevenson RD. Is evidence for homoeopathy reproducible? Lancet. 1994;344:1601-1606. Competing interests: None declared |
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Simon J Baker, Veterinary Surgeon House & Jackson Veterinary Surgeons, Blackmore, Essex, CM4 0LE
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This thread seems to have become colonised by homeopaths and homeopathy, so does risk deviating from its original purpose. However, Petter Viksveen's commentary on cherry-picking really does demand a response given that it perpetuates one of the most egregious examples of that very thing. Linde's (1997) (1) meta-analysis seems very close to the heart of many homeopaths, but less often do we see citations for Linde's (1999) re- analysis of their previous data (2). Viksveen has conformed to that pattern by omitting the later paper. Here is a quotation from the 1999 paper; "The evidence of bias weakens the findings of our original meta-analysis [7]. Since we completed our literature search in 1995, a considerable number of new homeopathy trials have been published. The fact that a number of the new high-quality trials (e.g. [14,15]) have negative results, and a recent update of our review for the most “original” subtype of homeopathy (classical or individualized homeopathy [16]), seem to confirm the finding that more rigorous trials have less-promising results. It seems, therefore, likely that our meta-analysis [7] at least overestimated the effects of homeopathic treatments." [original bibliographical citations retained, 7 represents their own 1997 paper] While homeopaths have lined up here to demand a fair representation of their literature, I would dearly like Viksveen to explain why he did not mention Linde's (1999) work and properly reflect upon its results. Furthermore, and in response to William Alderson (3), where there is sufficient evidence from well-controlled trials that a given therapy is useless, nothing can be gained by continuing to appeal to "clinical observation", we already know all that is being observed clinically are placebo responses and spontaneous changes. This, after all, is pretty much why controlled trial methodologies were developed in the first place: to sift real therapeutic effects from coincidence and wishful- thinking.. 1. Klaus Linde, Nicola Clausius, Gilbert Ramirez, Dieter Melchart, Florian Eitel, Larry V. Hedges, and Wayne B. Jonas. Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled trials. The Lancet 350 (9081) 834-843 (1997) 2. Klaus Linde, Michael Scholz, Gilbert Ramirez, Nicola Clausius, Dieter Melchart, and Wayne B. Jonas. Impact of Study Quality on Outcome in Placebo-Controlled Trials of Homeopathy. J. Clin. Epidemiol. 52 (7) 631- 636 (1999) 3. http://www.bmj.com/cgi/eletters/339/jul08_4/b2783#217596 Competing interests: None declared |
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E Ernst, Director Complementary Medicine Peninsula Medical School 25 Victoria Park Rd Exeter EX2 4NT UK
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I don't think that W Alderson has understood the difference between what he calls "research" and what i would call a popular book for lay people. The latter rarely contains references and frequently has to compromise between scientific precision and readability/accessability. If he wants to criticise my research, he should choose from one of my many papers in the peer-reviewed literature, not our book "Trick or Treament? Alternative Medicine on Trial". Competing interests: None declared |
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Hywel Thomas, Software Test Engineer 2, ME20 6AH
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My lay opinion is that there plenty of clever and/or eloquent people wasting time debating this. The likes of Ernzt and Singh, of course, must act as a defence against all this nonsense. Alternative medicine should be investigated and either become just medicine or have been investigated to death. The problem seems to be not that they can't be scientifically disproved or dismissed, but that they continue to be believed in despite being investigated to death. I can understand this more with chiropractic than with homeopathy, because at least chiropractors appear to do something : it's nonsense, but not plainly so. Homepathy, without any need of investigation or deep thought, is plainly nonsense of the highest order. I don't think it's necessary to understand the mechanics of medicine of proven efficacy. That is, we know it works, but don't know how : We can figure out the how later. I do think it's unnecessary, and appalling, to waste time and money on treatments that we already know don't work. As for the 'bogus' part, Singh qualified its meaning in the original article. A meaning that Eady ignored. Singh said the Snake Oil was bogus. He did not say that the Salesmen were. Even with the appalling existing libel laws, this case should have been dismissed immediately. Ultimately though, I hope good will come of it. The profile of chiropractic (along with homeopathic, reflexology etc) has been raised considerably among rational and sceptical people. Already the BCA has advised its members to remove claims of efficacy for asthma and infant colic from their websites. Competing interests: None declared |
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