Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
NICE
Of all types of alternative medicine, acupuncture is the one that has received the most approval from regular medicine. The benefit of that is that it’s been tested more thoroughly than most others. The result is now clear. It doesn’t work. See the evidence in Acupuncture is a theatrical placebo.
This blog has documented many cases of misreported tests of acupuncture, often from people have a financial interests in selling it. Perhaps the most egregious spin came from the University of Exeter. It was published in a normal journal, and endorsed by the journal’s editor, despite showing clearly that acupuncture didn’t even have much placebo effect.
Acupuncture got a boost in 2009 from, of all unlikely sources, the National Institute for Health and Care Excellence (NICE). The judgements of NICE and the benefit / cost ratio of treatments are usually very good. But the guidance group that they assembled to judge treatments for low back pain was atypically incompetent when it came to assessment of evidence. They recommended acupuncture as one option. At the time I posted “NICE falls for Bait and Switch by acupuncturists and chiropractors: it has let down the public and itself“. That was soon followed by two more posts:
NICE fiasco, part 2. Rawlins should withdraw guidance and start again“,
and
“The NICE fiasco, Part 3. Too many vested interests, not enough honesty“.
At the time, NICE was being run by Michael Rawlins, an old friend. No doubt he was unaware of the bad guidance until it was too late and he felt obliged to defend it.
Although the 2008 guidance referred only to low back pain, it gave an opening for acupuncturists to penetrate the NHS. Like all quacks, they are experts at bait and switch. The penetration of quackery was exacerbated by the privatisation of physiotherapy services to organisations like Connect Physical Health which have little regard for evidence, but a good eye for sales. If you think that’s an exaggeration, read "Connect Physical Health sells quackery to NHS".
When David Haslam took over the reins at NICE, I was optimistic that the question would be revisited (it turned out that he was aware of this blog). I was not disappointed. This time the guidance group had much more critical members.
The new draft guidance on low back pain was released on 24 March 2016. The final guidance will not appear until September 2016, but last time the final version didn’t differ much from the draft.
Despite modern imaging methods, it still isn’t possible to pinpoint the precise cause of low back pain (LBP) so diagnoses are lumped together as non-specific low back pain (NSLBP).
The summary guidance is explicit.
“1.2.8 Do not offer acupuncture for managing non-specific low back 7 pain with or without sciatica.”
The evidence is summarised section 13.6 of the main report (page 493).There is a long list of other proposed treatments that are not recommended.
Because low back pain is so common, and so difficult to treat, many treatments have been proposed. Many of them, including acupuncture, have proved to be clutching at straws. It’s to the great credit of the new guidance group that they have resisted that temptation.
Among the other "do not offer" treatments are
- imaging (except in specialist setting)
- belts or corsets
- foot orthotics
- acupuncture
- ultrasound
- TENS or PENS
- opioids (for acute or chronic LBP)
- antidepressants (SSRI and others)
- anticonvulsants
- spinal injections
- spinal fusion for NSLBP (except as part of a randomised controlled trial)
- disc replacement
At first sight, the new guidance looks like an excellent clear-out of the myths that surround the treatment of low back pain.
The positive recommendations that are made are all for things that have modest effects (at best). For example “Consider a group exercise programme”, and “Consider manipulation, mobilisation”. The use of there word “consider”, rather than “offer” seems to be NICE-speak -an implicit suggestion that it doesn’t work very well. My only criticism of the report is that it doesn’t say sufficiently bluntly that non-specific low back pain is largely an unsolved problem. Most of what’s seen is probably a result of that most deceptive phenomenon, regression to the mean.
One pain specialist put it to me thus. “Think of the billions spent on back pain research over the years in order to reach the conclusion that nothing much works – shameful really.” Well perhaps not shameful: it isn’t for want of trying. It’s just a very difficult problem. But pretending that there are solutions doesn’t help anyone.
Follow-up
The Yuletide edition of the BMJ carries a lovely article by Jeffrey Aronson, Patent medicines and secret remedies. (BMJ 2009;339:b5415).
I was delighted to be asked to write an editorial about it, In fact it proved quite hard work, because the BMJ thought it improper to be too rude about the royal family, or about the possibility of Knight Starvation among senior medics. The compromise version that appeared in the BMJ is on line (full text link).
The changes were sufficient that it seems worth posting the original version (with links embedded for convenience).
The cuts are a bit ironic, since the whole point of the article is to point out the stifling political correctness that has gripped the BMA, the royal colleges, and the Department of Health when it comes to dealing with evidence-free medicine. It has become commonplace for people to worry about the future of the print media, The fact of the matter is you can often find a quicker. smarter amd blunter response to the news on blogs than you can find in the dead tree media. I doubt that the BMJ is in any danger of course. It has a good reputation for its attitude to improper drug company influence (a perpetual problem for clinical journals) as well as for clinical and science articles. It’s great to see its editor, Fiona Godlee, supporting the national campaign for reform of the libel laws (please sign it yourself).
The fact remains that when it comes to the particular problem of magic medicine, the action has not come from the BMA, the royal colleges, and certainly not from the Department of Health, It has come from what Goldacre called the “intrepid, ragged band of bloggers”. They are the ones who’ve done the investigative journalism, sent complaints and called baloney wherever they saw it. This article was meant to celebrate their collective efforts and to celebrate the fact that those efforts are beginning to percolate upwards to influence the powers that be.
It seems invidious to pick on one example, but if you want an example of beautiful and trenchant writing on one of the topics dealt with here, you’d be better off reading Andrew Lewis’s piece "Meddling Princes, Medical Regulation and Licenses to Kill” than anything in a print journal.
I was a bit disappointed by removal of the comment about the Prince of Wales. In fact I’m not particularly republican compared with many of my friends. The royal family is clearly good for the tourist industry and that’s important. Since Mrs Thatcher (and her successors) destroyed large swathes of manufacturing and put trust in the vapourware produced by dishonest and/or incompetent bankers, it isn’t obvious how the UK can stay afloat. If tourists will pay to see people driving in golden coaches, that’s fine. We need the money. What is absolutely NOT acceptable is for royals to interfere in the democratic political process. That is what the Prince of Wales does incessantly. No doubt he is well-meaning, but that is not sufficient. If I wanted to know the winner of the 2.30 at Newmarket, it might make sense to ask a royal. In medicine it makes no sense at all. But the quality of the advice is irrelevant anyway. The royal web site itself says “As a constitutional monarch, the Sovereign must remain politically neutral.”. Why does she not apply that rule to her son? Time to put him over your knee Ma’am?
Two of the major bits that were cut out are shown in bold, The many other changes are small.
BMJ editorial December 2009
Secret remedies: 100 years onTime to look again at the efficacy of remedies Jeffrey Aronson in his article [1] gives a fascinating insight into how the BMA, BMJ and politicians tried, a century ago, to put an end to the marketing of secret remedies. They didn’t have much success. The problems had not improved 40 years later when A.J. Clark published his book on patent medicines [2]. It is astounding to see how little has changed since then. He wrote, for example, “On the other hand the quack medicine vendor can pursue his advertising campaigns in the happy assurance that, whatever lies he tells, he need fear nothing from the interference of British law. The law does much to protect the quack medicine vendor because the laws of slander and libel are so severe.”> Clark himself was sued for libel after he’d written in a pamphlet “ ‘Cures’ for consumption, cancer and diabetes may fairly be classed as murderous”. Although he initially tried to fight the case, impending destitution eventually forced him to apologise [3]. If that happened today, the accusation would have been repeated on hundreds of web sites round the world within 24 hours, and the quack would, with luck, lose [4]. As early as 1927, Clark had written “Today some travesty of physical science appears to be the most popular form of incantation” [5]. That is even more true today. Homeopaths regularly talk utter nonsense about quantum theory [6] and ‘nutritional therapists’ claim to cure AIDS with vitamin pills or even with downloaded music files. Some of their writing is plain delusional, but much of it is a parody of scientific writing. The style, which Goldacre [7] calls ‘sciencey’, often looks quite plausible until you start to check the references. A 100 years on from the BMA’s efforts, we need once again to look at the efficacy of remedies. Indeed the effort is already well under way, but this time it takes a rather different form. The initiative has come largely from an “intrepid, ragged band of bloggers” and some good journalists, helped by many scientific societies, but substantially hindered by the BMA, the Royal Colleges, the Department of Health and a few vice-chancellors. Even NICE and the MHRA have not helped much. The response of the royal colleges to the resurgence in magic medicine that started in the 1970s seems to have been a sort of embarrassment. They pushed the questions under the carpet by setting up committees (often populated with known sympathizers) so as to avoid having to say ‘baloney’. The Department of Health, equally embarrassed, tends to refer the questions to that well-known medical authority, the Prince of Wales (it is his Foundation for Integrated Health that was charged with drafting National Occupational Standards in make-believe subjects like naturopathy [8]. Two recent examples suffice to illustrate the problems. The first example is the argument about the desirability of statutory regulation of acupuncture, herbal and traditional Chinese medicine (the Pittilo recommendations) [9]. Let’s start with a definition, taken from ‘A patients’ guide to magic medicine’ [10]. “Herbal medicine: giving patients an unknown dose of an ill-defined drug, of unknown effectiveness and unknown safety”. It seems to me to be self-evident that you cannot start to think about a sensible form of regulation unless you first decide whether what you are trying to regulate is nonsense, though this idea does not seem to have penetrated the thinking of the Department of Health or the authors of the Pittilo report. The consultation on statutory regulation has had many submissions [11] that point out the danger to patients of appearing to give official endorsement of treatments that don’t work. The good news is that there seems to have been a major change of heart at the Royal College of Physicians. Their submission points out with admirable clarity that the statutory regulation of things that don’t work is a danger to patients (though they still have a blank spot about the evidence for acupuncture, partly as a result of the recent uncharacteristically bad assessment of the evidence by NICE [12]). Things are looking up. Nevertheless, after the public consultation on the report ended on November 16th, the Prince of Wales abused his position to make a well-publicised intervention on behalf of herbalists [13]. Sometimes I think his mother should give him a firm lesson in the meaning of the term ‘constitutional monarchy’, before he destroys it. The other example concerns the recent ‘evidence check: homeopathy’ conducted by the House of Commons Science and Technology Select Committee (SCITECH). First the definition [10]: “Homeopathy: giving patients medicines that contain no medicine whatsoever”. When homeopathy was dreamt up, at the end of the 18th century, regular physicians were lethal blood-letters, and it’s quite likely that giving nothing saved people from them. By the mid-19th century, discoveries about the real causes of disease had started, but homeopaths remain to this day stuck in their 18th century time warp. In 1842 Oliver Wendell Holmes said all that needed to be said about medicine-free medicine [14]. It is nothing short of surreal that the UK parliament is still discussing it in 2009. Nevertheless it is worth watching the SCITECH proceedings [15]. The first two sessions are fun, if only for the statement by the Professional Standards Director of Boots that they sell homeopathic pills while being quite aware that they don’t work. I thought that was rather admirable honesty. Peter Fisher, clinical director of the Royal Homeopathic Hospital, went through his familiar cherry-picking of evidence, but at least repeated his condemnation of the sale of sugar pills for the prevention of malaria. But for pure comedy gold, there is nothing to beat the final session. The health minister, Michael O’Brien, was eventually cajoled into admitting that there was no good evidence that homeopathy worked but defended the idea that the taxpayer should pay for it anyway. It was much harder to understand the position of the chief scientific advisor in the Department of Health, David Harper. He was evasive and ill-informed. Eventually the chairman, Phil Willis, said “No, that is not what I am asking you. You are the Department’s Chief Scientist. Can you give me one specific reference which supports the use of homeopathy in terms of Government policy on health?”. But answer came there none (well, there were words, but they made no sense). Then at the end of the session Harper said “homeopathic practitioners would argue that the way randomised clinical trials are set up they do not lend themselves necessarily to the evaluation and demonstration of efficacy of homeopathic remedies, so to go down the track of having more randomised clinical trials, for the time being at least, does not seem to be a sensible way forward.” Earlier, Kent Woods (CEO of the MHRA) had said “the underlying theory does not really give rise to many testable hypotheses”. These two eminent people seemed to have been fooled by the limp excuses offered by homeopaths. The hypotheses are testable and homeopathy, because it involves pills, is particularly well suited to being tested by proper RCTs (they have been, and when done properly, they fail). If you want to know how to do it, all you have to do is read Goldacre in the Guardian [16]. It really isn’t vert complicated. “Imagine going to an NHS hospital for treatment and being sent away with nothing but a bottle of water and some vague promises.” “And no, it’s not a fruitcake fantasy. This is homeopathy and the NHS currently spends around £10million on it.” That was written by health journalist Jane Symons, in The Sun [17]. A Murdoch tabloid has produced a better account of homeopathy than anything that could be managed by the chief scientific advisor to the Department of Health. And it isn’t often that one can say that. These examples serve to show that the medical establishment is slowly being dragged, from the bottom up, into realising that matters of truth and falsehood are more important than their knighthoods. It is all very heartening, both for medicine and for democracy itself. David Colquhoun. Declaration of interests. I was A.J. Clark chair of pharmacology at UCL, 1985 – 2004. 1. Aronson, JK BMJ 2009;339:b5415 2. Clark, A,J, (1938) Patent Medicines FACT series 14, London. See also Patent medicines in 1938 and now https://www.dcscience.net/?p=257 3. David Clark “Alfred Joseph Clark, A Memoir” (C. & J. Clark Ltd 1985 ISBN 0-9510401-0-3) 4. Lewis, A. (2007) The Gentle Art of Homeopathic Killing 5. A.J. Clark (1927) The historical aspect of quackery, BMJ October 1st 1927 6. Chrastina, D (2007) Quantum theory isn’t that weak, (response to Lionel Milgrom). 7 Goldacre, B. (2008) Bad Science. HarperCollins 8. Skills for Health web site 9. A very bad report: gamma minus for the vice-chancellor 10. A Patients’ Guide to Magic Medicine, and also in the Financial Times. 12. NICE fiasco, part 2. Rawlins should withdraw guidance and start again 13. BBC news 1 December 2009 Prince Charles: ‘Herbal medicine must be regulated’. 14. Oliver Wendell Holmes (1842) Homeopathy and Its Kindred Delusions. 15. House of Commons Science and technology committee. Evidence check: homeopathy. Videos and transcripts available at http://www.viewista.com/s/fywlp2/ez/1 16. Goldacre, B. A Kind of Magic Guardian 16 November 2007. 17. Homeopathy is resources drain says |
Follow-up
There is a good account of the third SCITECH session by clinical science consultant, Majikthyse, at The Three Amigos.
16 December 2009.. Recorded an interview for BBC Radio 5 Live. It was supposed to go out early on 17th.
17 December 2009. The editorial is mentioned in Editor’s Choice, by deputy editor Tony Delamothe. I love his way of putting the problem "too many at the top of British medicine seem frozen in the headlights of the complementary medicine bandwagon". He sounds remarkably kind given that I was awarded (by the editor, Fiona Godlee, no less) a sort of booby prize at the BMJ party for having generated a record number of emails during the editing of a single editorial (was it really 24?). Hey ho.
17 December 2009. More information on very direct political meddling by the Prince of Wales in today’s Guardian, and in Press Association report.
17 December 2009. Daily Telegraph reports on the editorial, under the heading “ ‘Nonsense’ alternative medicines should not be regulated“. Not a bad account for a non-health journalist.
17 December 2009. Good coverage in the excellent US blog, Neurologica, by the superb Steven Novella.’ “Intrepid, Ragged Band of Bloggers” take on CAM‘ provides a chance to compare and contrast the problems in the UK and the USA.’
18 December 2009. Article in The Times by former special advisor, Paul Richards. “The influence of Prince Charles the lobbyist is out of hand. Our deference stops us asking questions.”
“A good starting point might be publication of all correspondence over the past 30 years. Then we will know the extent, and influence, of Prince Charles the lobbyist.”
Comments in the BMJ Quite a lot of comments had appeared by January 8th, though sadly they were mostly from the usual suspects who appear every time one suggests evidence matters. A reply was called for, so I sent this (the version below has links).
After a long delay, this response eventually appeared in the BMJ on January 15 2010.
It’s good to see so many responses, though somewhat alarming to see that several of them seem to expect an editorial to provide a complete review of the literature. I ‘ll be happy to provide references for any assertion that I made.
I also find it a bit odd that some people think that an editorial is not the place to express an opinion robustly. That view seems to me to be a manifestation of the very sort of political correctness that I was deploring. It’s a bit like the case when the then health minister, Lord Hunt, referred to psychic surgery as a “profession” when he should have called it a fraudulent conjuring trick. Anything I write is very mild compared with what Thomas Wakley wrote in the Lancet, a journal which he founded around the time UCL came into existence. For example (I quote)
“[We deplore the] “state of society which allows various sets of mercenary, goose-brained monopolists and charlatans to usurp the highest privileges…. This is the canker-worm which eats into the heart of the medical body.” Wakley, T. The Lancet 1838-9, 1
I don’t think it is worth replying to people who cite Jacques Benveniste or Andrew Wakefield as authorities. Neither is it worth replying to people who raise the straw man argument about wicked pharmaceutical companies (about which I am on record as being as angry as anyone). But I would like to reply directly to some of the more coherent comments.
Sam Lewis and Robert Watson. [comment] Thank you for putting so succinctly what I was trying to say.
Peter Fisher [comment]. I have a lot of sympathy for Peter Fisher. He has attempted to do some good trials of homeopathy (they mostly had negative outcomes). He said he was "very angry" when the non-medical homeopaths were caught out recommending their sugar pills for malaria prevention (not that this as stopped such dangerous claims which are still commonplace). He agreed with me that there was not sufficient scientific basis for BSc degrees in homeopathy. I suppose that it isn’t really surprising that he continues to cherry pick the evidence. As clinical director of the Royal London Homeopathic Hospital and Homeopathic physician to the Queen, just imagine the cognitive dissonance that would result if he were to admit publicly that is all placebo after all. He has come close though. His (negative) trial for homeopathic treatment of rheumatoid arthritis included the words "It seems more important to define if homeopathists can genuinely control patients’ symptoms and less relevant to have concerns about whether this is due to a ‘genuine’ effect or to influencing the placebo response” [2]. [download
the paper]. When it comes to malaria, it matters a lot.
Adrian White [comment] seems to be cross because I cited my own blog. I did that simply because if he follows the links there he will find the evidence. In the case of acupuncture it has been shown time after time that "real" acupuncture does not differ perceptibly from sham. That is true whether the sham consists of retractable needles or real needles in the "wrong" places. A non-blind comparison between acupuncture and no acupuncture usually shows some advantage for the former but it is, on average, too small to be of much clinical significance [3]. I agree that there is no way to be sure that this advantage is purely placebo effect but since it is small and transient it really doesn’t matter much. Nobody has put it more clearly than Barker Bausell in his book, Snake Oil Science [4]
White also seems to have great faith in peer review. I agree that in real science it is probably the best system we have. But in alternative medicine journals the "peers" are usually other true believers in whatever hocus pocus is being promoted and peer reveiw breaks down altogether.
R. M. Pittilo [comment] I’m glad that Professor Pittilo has replied in person because I did single out his report for particular criticism. I agree that his report said that NHS funding should be available to CAM only where there is evidence of efficacy. That was not my criticism. My point was that in his report, the evidence for efficacy was assessed by representatives of Herbal Medicine, Chinese Medicine and Acupuncture (four from each). Every one of them would have been out of work if they had found their subjects were nonsense and that, no doubt, explains why the assessment was so bad. To be fair, they did admit that the evidence was not all that it might be and recommended (as always) more research I’d like to ask Professor Pittilo how much money should be spent on more research in the light of the fact that over a billion dollars has been spent in the USA on CAM research without producing a single useful treatment. Pittilo says "My own view is that both statutory regulation and the quest for evidence should proceed together" but he seems to neglect the possibility that the quest for evidence might fail. Experience in the USA suggests that is exactly what has, to a large extent, already happened.
I also find it quite absurd that the Pittilo report should recommend, despite a half-hearted admission that the evidence is poor, that entry to these subjects should be via BSc Honours degrees. In any case he is already thwarted in that ambition because universities are closing down degrees in these subjects having realised that the time to run a degree is after, not before, you have some evidence that the subject is not nonsense. I hope that in due course Professor Pittilo may take the same action about the courses in things like homeopathy that are run by the university of which he is vice-chancellor. That could only enhance the academic reputation of Robert Gordon’s University.
George Lewith [comment] You must be aware that the proposed regulatory body, the Health Professions Council, has already broken its own rules about "evidence-based practice" by agreeing to take on, if asked, practitioners of Herbal Medicine, Chinese Medicine and Acupuncture. They have (shamefully) excluded the idea that claims of efficacy would be regulated. In other word they propose to provide exactly the sort of pseudo-regulation which would endanger patients They are accustomed to the idea that regulation is to do only with censoring practitioners who are caught in bed with patients. However meritorious that may be, it is not the main problem with pseudo-medicine, an area in which they have no experience. I’m equally surprised that Lewith should recommend that Chinese evaluation of Traditional Chinese medicine should be included in meta-analyses, in view of the well-known fact that 99% of evaluations from China are positive: “No trial published in China or Russia/USSR found a test treatment to be ineffective” [5]. He must surely realise that medicine in China is a branch of politics. In fact the whole resurgence in Chinese medicine and acupuncture in post-war times has less to do with ancient traditions than with Chinese nationalism, in particular the wish of Mao Tse-Tung to provide the appearance of health care for the masses (though it is reported that he himself preferred Western Medicine).
1. Lord Hunt thinks “psychic surgery” is a “profession”. https://www.dcscience.net/?p=258
2. Fisher, P. Scott, DL. 2001 Rheumatology 40, 1052 – 1055. [pdf file]
3. Madsen et al, BMJ 2009;338:a3115 [pdf file]
4. R, Barker Bausell, Snake Oil Science, Oxford University Press, 2007
5. Vickers, Niraj, Goyal, Harland and Rees (1998, Controlled Clinical Trials, 19, 159-166) “Do Certain Countries Produce Only Positive Results? A Systematic Review of Controlled Trials”. [pdf file]
15 January 2010. During the SciTech hearings, Kent Woods (CEO of the MHRA) made a very feeble attempt to defend the MHRA’s decision to allow misleading labelling of homeopathic products. Now they have published their justification for this claim. It is truly pathetic, as explained by Martin at LayScience: New Evidence Reveals the MHRA’s Farcical Approach to Homeopathy. This mis-labelling cause a great outcry in 2006, as documented in The MHRA breaks its founding principle: it is an intellectual disgrace, and Learned Societies speak out against CAM, and the MHRA.
22 January 2010 Very glad to see that the minister himself has chosen to respond in the BMJ to the editorial
|
Rt Hon. Mike O’Brien QC MP, Minister of State for Health Services I am glad that David Colquhoun was entertained by my appearance before the Health Select Committee on Homeopathy. But he is mistaken when he says, “you cannot start to think about a sensible form of regulation unless you first decide whether or not the thing you are trying to regulate is nonsense.” Regulation is about patient safety. Acupuncture, herbal and traditional Chinese medicine involve piercing the skin and/or the ingestion of potentially harmful substances and present a possible risk to patients. The Pittilo Report recommends statutory regulation and we have recently held a public consultation on whether this is a sensible way forward. Further research into the efficacy of therapies such as Homeopathy is unlikely to settle the debate, such is the controversy surrounding the subject. That is why the Department of Health’s policy towards complementary and alternative medicines is neutral. Whether I personally think Homeopathy is nonsense or not is besides the point. As a Minister, I do not decide the correct treatment for patients. Doctors do that. I do not propose on this occasion to interfere in the doctor-patient relationship. |
Here is my response to the minister
|
I am very glad that the minister himself has replied. I think he is wrong in two ways, one relatively trivial but one very important. First, he is wrong to refer to homeopathy as controversial. It is not. It is quite the daftest for the common forms of magic medicine and essentially no informed person believes a word of it. Of course, as minister, he is free to ignore scientific advice, just as the Home Secretary did recently. But he should admit that that is what he is doing, and not hide behind the (imagined) controversy. Second, and far more importantly, he is wrong, dangerously wrong, to say it I was mistaken to claim that “you cannot start to think about a sensible form of regulation unless you first decide whether or not the thing you are trying to regulate is nonsense". According to that view it would make sense to grant statutory regulation to voodoo and astrology. The Pittilo proposals would involve giving honours degrees in nonsense if one took the minister’s view that it doesn’t matter whether the subjects are nonsense or not. Surely he isn’t advocating that? The minister is also wrong to suppose that regulation, in the form proposed by Pittilo, would do anything to help patient safety. Indeed there is a good case to be made that it would endanger patients (not to mention endangering tigers and bears). The reason for that is that the main danger to patients arises from patients being given “remedies” that don’t work. The proposed regulatory body, the Health Professions Council, has already declared that it is not interested in whether the treatments work or not. That in itself endangers patients. In the case of Traditional Chinese Medicine, there is also a danger to patients from contaminated medicines. The HPC is not competent to deal with that either. It is the job of the MHRA and/or Trading Standards. There are much better methods of ensuring patient safety that those proposed by Pittilo. In order to see the harm that can result from statutory regulation, it is necessary only to look at the General Chiropractic Council. Attention was focussed on chiropractic when the British Chiropractic Association decided, foolishly, to sue Simon Singh for defamation. That led to close inspection of the strength of the evidence for their claims to benefit conditions like infant colic and asthma. The evidence turned out to be pathetic, and the result was that something like 600 complaints were made to the GCC about the making of false health claims (including two against practices run by the chair of the GCC himself). The processing of these complaints is still in progress, but what is absolutely clear is that the statutory regulatory body, the GCC, had done nothing to discourage these false claims. On the contrary it had perpetrated them itself. No doubt the HPC would be similarly engulfed in complaints if the Pittilo proposals went ahead. It is one thing to say that the government chooses to pay for things like homeopathy, despite it being known that they are only placebos, because some patients like them. It is quite another thing to endanger patient safety by advocating government endorsement in the form of statutory regulation, of treatments that don’t work. I would be very happy to meet the minister to discuss the problems involved in ensuring patient safety. He has seen herbalists and other with vested interests. He has been lobbied by the Prince of Wales. Perhaps it is time he listened to the views of scientists too. |
Both the minister’s response, and my reply, were reformatted to appear as letters in the print edition of the BMJ, as well as comments on the web..
Chiropractors are getting very touchy indeed, all over the world. And no wonder, because their claims are being exposed as baseless as never before, in the wake of their attempts to stifle criticism by legal action..
In March, Shaun Holt appeared on Breakfast TV in New Zealand. Holt has done a lot of good work on TV in debunking some of the preposterous claims made by quacks. See him on YouTube.
This time he talked about chiropractic. Here is the video.
One could argue that he was over generous to chiropractic, especially when talking about their effectiveness in treating low back pain. He said, quite rightly, that chiropractors are no better than physiotherapists at treating low back pain.
But a recent trial suggests that neither are much good. “A randomised controlled trial of spinal manipulative therapy in acute low back pain” (Juni et al., 2009 in the BMJ; see also coverage in Pulse). This trial compared standard care with standard care plus spinal manipulative therapy (SMT). The results were negative, despite the fact that this sort of A + B vs B design is inherently biassed in favour of the treatment (see A trial design that generates only ”positive” results, Ernst & Lee 2008, Postgrad Med J.).
"SMT was performed by a specialist in manual medicine, chiropractice and rheumatology (GH), a specialist in physical medicine (DV) or an osteopath (RvB), all proficient in SMT."
"Conclusions: SMT is unlikely to result in relevant early pain reduction in patients with acute low back pain."
Admittedly, the trial was quite small (104 patients, 52 in each group) so it will need to be confirmed. but the result is entirely in line with what we knew already.
It also adds to the evidence that the recommendation by NICE of SMT by chiropractors constitutes their biggest failure ever to assess evidence properly. If NICE don’t amend this advice soon, they are in danger of damaging their hitherto excellent record.
Despite the moderate tone and accuracy of what Holt said on TV, the New Zealand Chiropractors’ Association made a formal complaint. That is what they like to do, as I learned recently, to my cost. It is so much easier than producing evidence.
Quite absurdly the New Zealand Broadcasting Standards Authority (BSA) has upheld some of the complaints. Their judgement can be read here.
The BSA consists of four people, two lawyers and two journalists. So not a trace of scientific expertise among them. Having people like that judging the claims of chiropractors makes as much sense as having them judged by Mr Justice Eady. They seem to be the sort of people who think that if there is a disagreement, the truth must lie half-way between the opposing views.
One of the BSA members, Tapu Misa, has used her newspaper column to quote approvingly the views of the notorious Dr Mercola web site on flu prevention “Your best defence, it says, is to eat right, get lots of sleep, avoid sugar and stress, load up on garlic, Vitamin D and krill oil”. (Snake oil is said to be good too.) There are some odd attitudes to science in some of her other columns too (e.g. here and here). Not quite the person to be judging the evidence for and against chiropractic, I think.
In fact the TV show in question was more than fair to chiropractors. It adopted the media’s usual interpretation of fair and balanced: equal time for the flat earthers. A Chiropractor was invited to reply to Holt’s piece. Here he is.
The chiropractor, Doug Blackbourn, started very plausibly, though a tendency to omit every third syllable made transcription hard work. He established that if you cut yourself you get better (without any help). He established that nerves run down the spinal cord. So far, so good. But then he quickly moved on to the usual flights of fancy.
"We have two premises. The body heals itself and the nervous system runs the body. Now the nervous system runs the body, travels down through the spinal cord so chiropractic is not based on the belief that, you know, energy flows, it’s based on the fact that your nervous system runs the body and [inaudible] affects the overall health of the body"
This statement is totally vague. It has nothing whatsoever to do with the main question, can chiropractors do anything useful. It is sheer flannel.
We’re seeing people, heck, diabetes. I had a quadriplegic come in one time for adjustment, we’ve got stroke people, we’ve got all sorts of conditions. We’re not treating the condition, We’re allowing, checking the spine to see if there’s any interference there that will slow the body down"
“Interference”? “slowing the body down”? These are utterly meaningless phrases that simply serve to distract from the only question that matters.
"Chiropractice is the most safest [sic] profession to go to to get your spine adjusted"
Hmm I thought it was the only job that uses the word ‘adjustment’.
Worst of all was his response to a question about asthma.
Presenter: "So chiropractors are not out there claiming they will cure asthma for example?". Chiropractor: "No"
This is simply untrue, both in New Zealand and in the UK. For a start, just look at what Blackbourn’s own web site says about asthma.
"The challenge, of course, with allergy and asthma medication is there is no end-point. There is no cure. Asthma and allergies, for the most part, are lifelong conditions requiring lifelong medication. Might there be a better way, an alternative solution?
“Alternative” is the key word. Medical treatment is designed to combat symptoms, and is successful to a certain extent with allergies and asthma. Underlying causes are not addressed, however, and symptoms continue year after year. What else might be done?
Enter chiropractic care. Chiropractic health care, with its unique comprehensive approach, is able to offer positive benefit to a variety of conditions and ailments. In the case of allergies and asthma, these “hypersensitivity conditions” may respond well to therapy designed to normalize the body’s flow of nerve signals. To use a metaphor, chiropractic treatment removes roadblocks to the body’s natural healing abilities. Restoring these imbalances may help reduce such hypersensitivity reactions."
Blackbourn’s web site describes him thus
"As a Doctor of Chiropractic, Dr. Doug Blackbourn . . ."
But the qualifications of “Dr” Blackbourn are B.App.Sc (Chiro) M.N.Z.C.A , the same as those of “Dr” Brian Kelly.
After a performance like this, perhaps someone should submit a complaint to the New Zealand Broadcasting Standards Authority.
After all, I notice that they have dismissed complaints from one chiropractor, Sean Parker, after a TV programme looked at the business practices of his private chiropractic practice, The Spinal Health Foundation. Perhaps the BSA understands business better than it understands science.
Follow-up
Is chiropractic crumbling in New Zealand? The New Zealand College of Chiropractic featured in my editorial in the New Zealand Medical Journal, and in the fallout from that article, It’s principle, “Dr” Brian Kelly (B App Sci (Chiro)) seems to be getting desperate. His college is now canvassing for recruits in Canada. They are promised all the woo.
- Subluxation centered techniques – Gonstead, Toggle Recoil, Thompson, Diversified
- Traditional philosophy featuring vitalism and innate healing – congruent curriculum
Perhaps Canada is a good place to recruit, gven the $500 million class action being brought against chiropractors in Canada, after Sandra Nette became tetraplegic immediately after a chiropractor manipulated her neck, Canadian chiropractors must be looking for somewhere to hide.
Stuff and Nonsense. jdc described this story at the time the complaint was lodged.
Shaun Holt’s own blog follows the action.
New Zealand Doctor covers the story.
Bay of Plenty Times “Bay researcher slams television complaint ruling“
Acupuncture has been in the news since, in a moment of madness, NICE gave it some credence,
Some people still seem to think that acupuncture is somehow more respectable than, say, homeopathy and crystal healing. If you think that, read Barker Bausell’s book ot Trick or Treatment. It is now absolutely clear that ‘real’ acupuncture is indistinguishable from sham, whether the sham control uses retractable needles, or real needles in the ‘wrong’ places. There has been no clear demonstration of long-lived benefits in any condition, and it is likely that it is no more than a theatrical placebo.
In particular, the indistinguishability of ‘real’ and sham acupuncture shows, beyond reasonable doubt that all the stuff about “energy flow in meridians” is so much hokum.
There is a small group of ‘medical acupuncturists‘ that believes that it is hokum. but who nonetheless maintain that acupuncture works, despite the evidence to the contrary. But most acupuncturists go for the wholesale gobbledygook.
If you don’t believe that, take a look at the exam paper that has come into my possession. It is this year’s exam from the University of Salford. Salford has, very sensibly, now decided to stop all its degrees in alternative medicine, so don’t hold this against the university too much.
You can download the entire exam paper. Here are a few highlights.
So students, in 2009, are being taught the crudest form of vitalism.
Oh really. Perhaps protons neutrons and electrons?
OK I’d fail that one because the words have no obvious meaning at all.
Perhaps an elementary textbook of embryology would help?
How one would love to see a set of model answers for these questions.
All this is ancient hokum being taugh to hapless students in the 21st century as though it were fact. The University of Salford has understood that and closed the course. All we need now is for NICE and the Department of Health to understand what it is that they are promoting.
NICE neglected the cultural cost of their guidance
When National Institute for Health and Clinical Excellence (NICE) included an acupuncture option on their low back pain guidance, they quite forget that one effect of their decision would be to ensure that new generations of students would have their minds poisoned with intellectual junk like this. That is why NICE really must think again. . See also
NICE falls for bait and switch by acupuncturists and chiropractors
NICE fiasco part 2 Rawlins should withdraw guidance and start again
NICE fiasco Part 3. Too many vested interests, not enough honesty
Pittilo and statutory regulation
Public consultation is due to open shortly on the appalling report of the Department of Health Steering Group on the Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK (see also, The Times)
One of the recommendations is that acupuncture and Chinese herbal medicine should have statutory regulation by the Health Professions Council (HPC), despite the fact that that would involve the HPC breaking its own rules. Another recommendation of Pittilo is that entry to the “profession” (his word, not mine) should be by means of honours degree only. So he wants to impose on students exams like this one in order to “protect the public”? The absurdity of that proposal should be obvious now. This exam paper will form part of my evidence to the consultation.
And there is one other small problem. Universities are busy shutting down their degrees in alternative medicine, now that the ridiculousness of what is taught has been exposed. They have shut down entirely at the University of Salford and at the University of Central Lancashire, And even the University of Westminster is working on closing them.
All we need now is for the common sense and integrity that has been shown by these universities to spread to the Department of Health (and NICE).
Follow-up
This is another short interruption in the epic self-destruction of chiropractors. In a sense it is more serious. One expects quacks to advocate quackery. What you don’t expect is that the National Institute of Clinical Excellence (NICE) will endorse it. Neither do you expect the Medicines and Healthcare products Regulatory Agency (MHRA) to betray its mandate to make sure that medicines work.
The saga of the NICE low back pain guidance has been the subject of a deluge of criticism, It seems doubtful that the guidance can survive, not least because of its absurd endorsement of chiropractic, at a time when chiropractic is undergoing self-immolation as a consequence of the persecution of Simon Singh by the British Chiropractic Association (see here, and here, and here, and here and thousands of other sites).
The other betrayal has come to the for after the MHRA approved highly misleading labelling of a homeopathic preparation. At the time,
in 2006, when the principle was approved by the MHRA, just about every scientific organisation, even the Royal Society, condemned the action. What was discouraging that the clinical organisations all stayed silent. It is still a mystery why the MHRA made this enormous mistake, Some said that European regulations required it, but that is quite untrue, as Les Rose has shown. It appears to have been the result of a pusillanimous MHRA bowing to pressure from a deeply unscientific Department of Health (a letter from Caroline Flint at the time borders on the surreal).
On 20 May 2009, the British Medical Journal printed an article Drugs agency grants its first licence to homoeopathic product by Deborah Cohen (available free). The comments were mostly highly critical of the MHRA. The BMJ asked, as it does from time to time, for my comment to be converted to a letter
for the print edition. That isn’t freely available, so here it is.
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Published 9 June 2009, doi:10.1136/bmj.b2333 LettersHomoeopathic product licenceMHRA label seems to be illegalThe strap line for the Medicines and Healthcare products Regulatory Agency (MHRA) is “We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe.” Yet the MHRA has made mockery of its own aims by ignoring the bit about “ensuring that medicines work” and allowing Arnica 30C pills to be labelled: “a homoeopathic medicinal product used within the homoeopathic tradition for the symptomatic relief of sprains, muscular aches, and bruising or swelling after contusions.”1 This label should be illegal anyway because the pills contain no trace of the ingredient on the label, but this deceit has been allowed through a legal loophole for a long time now. If you sold strawberry jam that contained not a trace of strawberry you’d be in trouble. But I can see no legal loophole that allows the manufacturers of Arnica 30C to evade the provisions of the Consumer Protection from Unfair Trading Regulations 2008. One of the 31 commercial practices which are in all circumstances considered unfair is “falsely claiming that a product is able to cure illnesses, dysfunction, or malformations.” The consumer protection laws apply to the way that “the average consumer” will interpret the label. The average consumer is unlikely to know that “used within the homoeopathic tradition” is a form of weasel words that actually means “there isn’t a jot of evidence that the medicine works.” Since there is not the slightest evidence that Arnica 30C pills provide symptomatic relief of sprains, etc, the labelling that the MHRA has approved seems to be illegal. The MHRA is not selling anything itself, so I presume that it won’t find itself in court, but anyone who follows its advice could well do so. Cite this as: BMJ 2009;338:b2333 David Colquhoun, research professor1 University College London, London WC1E 6BT Competing interests: None declared. References |
It is, I suppose, just a sign of the chaos that reigns in the multiple agencies and quangos responsible for ‘regulation’ that one arm of government proposes action that a different branch would consider illegal. That is an inevitable consequence of trying to regulate something without first deciding whether it is nonsense or not. The Department of Health appears to be quite incapable of grasping this simple and obvious fact.
Follow-up
Health: best treatments. The Guardian seems to the be picking up BMJ stories and ran this one.
The first post was NICE falls for Bait and Switch by acupuncturists and chiropractors: it has let down the public and itself.
That was followed by NICE fiasco, part 2. Rawlins should withdraw guidance and start again.
Since then, something of a maelstrom has engulfed NICE, so it’s time for an update.
It isn’t only those who are appalled that NHS should endorse voodoo medicine on the basis of very slim evidence who are asking NICE to rethink their guidance on low back pain. Pain specialists are up in arms too, and have even started a blog, ‘Not Nearly as NICE as you think …‘, to express their views. Equally adverse opinions are being expressed in the Britsh Medical Journal. A letter there is signed by over 50 specialists in pain medicine. It ends thus
“Because of these new guidelines patients will continue to experience unnecessary pain and suffering and their rights to appropriately individually tailored treatment have been removed on the basis of a flawed analysis of available evidence. We believe the guidelines do not reflect best practice, remove patient choice and are not in our patients’ best interests.”
In a contribution headed “NICE misguidance”. Dr Michel Vagg ends
It seems to me that this guideline has been used as a propaganda vehicle to allow cherry-picked evidence to be enshrined as doctrine. This is an abuse of the guideline development process . . . ”
I have to say, though, that it seems to me that some of these people are promoting their own interests as much as chiropractors and acupuncturists. The evidence that spinal injections produce worthwhile benefits seems to be as thin as the evidence that chiropractic and acupuncture produce worthwhile benefits. But no doubt the injections are good for the budgets of PCTs or private practice doctors.. Could it perhaps be the case that some of the clinicians’ anger is being generated by doctors who are rushing to defend their own favourite ineffective treatment?
Why, oh why, can’t either NICE or the pain consultants bring themselves to state the obvious, that nothing works very well. The only thing that can be said for most of the regular treatments is that although they may not be much more effective than acupuncture or chiropractic, at least they don’t come with the intellectually-offensive hokum that accompanies the latter. Very sensible attempts have been made to identify the cause of low back pain [reviewed here], Occasionally they succeed. Mostly they don’t.
One clinician’s letter deserves special attention because it goes into the evidence, and the costs, in some detail. Its conclusions are very different from those in the NICE guidance.
The letter, a Review of NICE guidance, is from Dr C.J.D. Wells [download the whole letter]. He is a pain relief consultant from Liverpool.
Let’s look at some highlights.
Wells points out the absurdity of the cost estimates
“In the pricing section, they estimate that this will require an increase of facilities so that 3,500 patients can be treated instead of 1,000 at present (again see comments on pricing). This is not many treatments for the 20 million sufferers, of whom we can estimate that at least 2 million will have significant long-term disability and psychological distress”
And that is without even costing all the secondary costs of miseducating a new generation of students in fables about “Qi”, meridians, energy flow, subluxations and innate intelligence.
“The abysmal ignorance of the committee is reflected in the poor overall advice. So if you have a committee with special interests in Exercise, Manipulation, PMP’s, and Surgery, and you call an expert on Acupuncture, you get advice to use Exercise, Manipulation, Acupuncture, PMP’s and Surgery. Amazing.”
Another pain consutant, Charles Guaci, says in a comment in the Daily Mail.
I am a Pain Consultant of 30 years experience, have published two books (one translated into different languages).
NICE never asked me for my opinion.
This is the most ridicuculous pseudo-scientific document I have ever seen.
The panel consisted of a surgeon, psychologist, osteopath, acupuncturist a physiotherapist and an academic; not one pain consultant! The conclusions are simply a means of increasing the employment of their friends!
All evidence submitted to NICE was ignored.
It is almost certain than unless NICE rethink their ideas that Pain Consultants will be seeking a judicial review as well as full disclosure of how the panel arrived at their bizarre findings under the Freedom of information act.
Patients should realise that they are being taken for a ride.
Despite the outcry from opponents of magic medicine and from pain specialists, the assessment by the normally excellent NHS Choices site was disappointing. It made no mention at all of the secondary consequences of recommending CAM and described the assertions of the guidance group quite uncritically.
The reputation of NICE
NICE has been criticised before, though usually unjustly. In the past I have often supported them. For example. when NICE said that treatment of dementia with anticholinesterase drugs like galantamine was ineffective, there was a great outcry, but NICE were quite right. There is little or no rationale for such treatments, and more importantly, very little evidence that they work. But patients, especially when they are desperate, have greater faith in drug treatments than most pharmacologists, They want to clutch at straws. A bit like the NICE guidance committee, faced with a bunch of treatments most of which are almost ineffective, clutched at the straws of acupuncture and chiropractic. But this time it isn’t only the patients who are cross. It is most of the medical and scientific world too.
One interpretation of these bizarre events is that they represent a case of medical/scientific arrogance. Ben Goldacre wrote of another aspect of the same problem thus week, in Dodgy academic PR [download the paper on which this is based].
The first job of a scientist is to say openly when the answer to a question is not known. But scientists are under constant pressure to exaggerate the importance of their results. Last year we published an article which I feel may, if verified, turn out to be the second most important that I have ever been an author on. Because it happened to be published in Nature (not because of its quality), a press release was written (by an arts graduate!). It took some argument to prevent the distorted and exaggerated account being imposed on the public. This is typical of the sort of thing reported in Goldacre’s column. I reported a similar case a while ago, Why honey isn’t a wonder cough cure: more academic spin.
If NICE does not reconsider this guidance, it is hard to see how it can be taken seriously in the future. I hope that when NICE’s director, Professor Sir Michael Rawlins, returns from his trips abroad, he will find time to look at the case himself.
Indirectly, then, it can be argued that NICE’s bizarre guidance is just another manifestation of the management of science being passed from the hands of scientists into the hands of administrators and spin experts. It is yet another example of DC’s rule
Never trust anyone who uses the word ‘stakeholder’
Some bone-headed bureaucrat decides that any charlatan or quack is a ‘stakeholder’ in the provision of NHS care and gives them a quite disproportionate say in how taxpayers’ money is spent. The bureaucrats are so busy following processes and procedures, ticking boxes, and so deficient in scientific education, that they failed to notice that they’ve been caught out by the old trick of used car salesmen, bait and switch.
The consequences
The expected consequences have already started to materialise. The Prince of Wales’ Foundation for Magic Medicine is jubilant about having been endorsed by NICE. And I’m told that “The chiropractors have now just written letters to all health boards in Scotland asking for contracts for their services to deal with back pain”.
There could hardly have been a worse time for NICE to endorse chiropractic. We are in the middle of a storm about free speech because of the disgraceful action of the British Chiropractic Associaton in suing one of our best science writers, Simon Singh, for defamation because he had the temerity to express an opinion, Of course, even if the BCA wins in court, it will be the overall loser, because chiropractic claims are now being scrutinised as never before (just look at what they told me).
Follow-up
A much-cited paper. The paper that is most often cited by chiropractors who claim to be able to cure colic by spinal manipulation is Klougart N, Nilsson N and Jacobsen J (1989) Infantile Colic Treated by Chiropractors: A Prospective Study of 316 Cases, J Manip Physiol Ther,12:281-288. This is not easy to get hold of but Steve Vogel has sent me s scanned copy which you can download here. As evidence it is about as useless as the infamous Spence study so beloved of homeopaths. There was no control group at all. It simply follows 316 babies and found that most of them eventually got better. Well, they do, don’t they? It is a sign of the pathetic standard of reaearch in chiropractic that anyone should think this paper worth mentioning at all.
June 6 2009. More flak for NICE from the Royal College of Anaesthetists, and more adverse comment in the BMJ. And of course the blogs. for example, “If this is “evidence based medicine” I want my old job back“.
“Acupuncture on the NHS: a dangerous precedent”: a good analysis at counterknowledge.com.
June 6 2009, Comment sent to the BMJ. The comment was submitted, as below, early on Friday 5th June. The BMJ said it was a “sensitive issue” and for the next five days lawyers pondered over it.
Underwood and Littlejohns describe their guidance as being a “landmark”. I can only agree with that description. It is the first time that NICE has ever endorsed alternative medicine in the face of all the evidence. The guidance group could hardly have picked a worse moment to endorse chiropractic. Chiropractors find it so hard to find evidence for their practices that, when one of our finest science writers, Simon Singh, asked to see the evidence they sued him for defamation. I suggest that the guidance group should look at the formidable list of people who are supporting Singh, after his brave decision to appeal against this iniquitous persecution.
Of course I’m sure this bizarre decision has nothing to do with the presence on the guidance group of Peter Dixon, chair of the General Chiropractic Council. Nevertheless, I am curious to know why it is that when I telephoned two of the practices belonging to Peter Dixon Associates, I was told that they could probably treat infantile colic and asthma. Such claims have just been condemned by the Advertising Standards Authority.
The low back pain guidance stands a good chance of destroying NICE’s previously excellent reputation for dispassionate assessment of benefits and costs. Yes, that is indeed a landmark of sorts.
If NICE is ever to recover its reputation, I think that it will have to start again. Next time it will have to admit openly that none of the treatments work very well in most cases. And it will have to recognise properly the disastrous cultural consequences of giving endorsement to people who, when asked to produce evidence, resort to legal intimidation.
Eventually, on Wednesday 10 June the comment appeared in the BMJ, and it wasn’t greatly changed. Nevertheless if is yet another example of legal chill. This is the final version.
Underwood and Littlejohns describe their guidance as being a “landmark”. I can only agree with that description. It is the first time that NICE has ever endorsed alternative medicine in the face of all the evidence. The guidance group could hardly have picked a worse moment to endorse chiropractic. Chiropractors are so sensitive about criticisms of their practices that, when one of our finest science writers, Simon Singh, queried the evidence-base for their therapeutic claims they sued him for defamation. I suggest that the guidance group should look at the formidable list of people who are supporting Singh, after his brave decision to appeal against an illiberal court ruling in this iniquitous persecution.
One wonders whether this bizarre decision by NICE has anything to do with the presence on the guidance group of Peter Dixon, chair of the General Chiropractic Council. I am also curious to know why it is that when I telephoned two of the practices belonging to Peter Dixon Associates, I was told that chiropractic could be effective in the treatment of infantile colic and asthma. Similar claims about treating colic have just been condemned by the Advertising Standards Authority.
The low back pain guidance stands a good chance of destroying NICE’s previously excellent reputation for dispassionate assessment of benefits and costs. Yes, that is indeed a landmark of sorts.
If NICE is ever to recover its reputation, I think that it will have to start again. Next time it will have to admit openly that none of the treatments works very well in most cases. And it will have to recognise properly the disastrous cultural consequences of giving endorsement to people who, instead of engaging in scientific debate, resort to legal intimidation.
Bait and switch. Oh dear, oh dear. Just look at this. British Chiropractic Association tell their members to hide their sins from prying eyes.
Excellent round-up of the recent outburst of writing about “chiroquacktic” (Tut, tut, is there no respect?).
Dr Crippen writes “NICE recommends a cure for all known disease” [Ed some exaggeration, surely]
First the MHRA lets down the public by allowing deceptive labelling of sugar pills (see here, and this this blog). Now it is the turn of NICE to betray its own principles.
The National Institute for Health and Clinical Excellence (NICE) describes its job thus
“NICE is an independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health.”
Its Guidance document on Low Back Pain will be published on Wednesday 27 May 2009, but the newspapers have already started to comment, presumably on the assumption that it will have changed little from the Draft Guidance of September 2008. These comments may have to be changed as soon as the final version becomes available.
The draft guidance, though mostly sensible, has two recommendations that I believe to be wrong and dangerous. The recommendations include (page 7) these three.
- Consider offering a course of manual therapy including spinal manipulation of up to 9 sessions over up to 12 weeks.
- Consider offering a course of acupuncture needling comprising up to 10 sessions over a period of up to 12 weeks.
- Consider offering a structured exercise programme tailored to the individual.
All three of this options are accompanied by a footnote that reads thus.
“A choice of any of these therapies may be offered, taking into account patient preference.”
On the face if it, this might seem quite reasonable. All three choices seem to be about as effective (or ineffective) as each other, so why not let patients choose between them?
Actually there are very good reasons, but NICE does not seem to have thought about them. In the past I have had a high opinion of NICE but it seems that even they are now getting bogged down in the morass of political correctness and officialdom that is the curse of the Department of Health. It is yet another example of DC’s rule number one.
Never trust anyone who uses the word ‘stakeholder’.
They do use it, often.
So what is so wrong?
For a start, I take it that the reference to “spinal manipulation” in the first recommendation is a rather cowardly allusion to chiropractic. Why not say so, if that’s whar you mean? Chiropractic is mentioned in the rest of the report but the word doesn’t seem to occur in the recommendations. Is NICE perhaps nervous that it would reduce the credibility of the report if the word chiropractic were said out loud?
Well, they have a point, I suppose. It would.
That aside, here’s what’s wrong.
The Evidence
I take as my premise that the evidence says that no manipulative therapy has any great advantage over the others. They are all more or less equally effective. Perhaps I should say, more or less equally ineffective, because anyone who claims to have the answer to low back pain is clearly deluded (and I should know: nobody has fixed mine yet). So for effectiveness there are no good grounds to choose between exercise, physiotherapy, acupuncture or chiropractic. There is, though, an enormous cultural difference. Acupuncture and chiropractic are firmly in the realm of alternative medicine. They both invoke all sorts of new-age nonsense for which there isn’t the slightest good evidence. That may not poison your body, but it certainly poisons your mind.
Acupuncturists talk about about “Qi”, “meridians”, “energy flows”. The fact that “sham” and “real” acupuncture consistently come out indistinguishable is surely all the evidence one needs to dismiss such nonsense. Indeed there is a small group of medical acupuncturists who do dismiss it. Most don’t. As always in irrational subjects, acupuncture is riven by internecine strife between groups who differ in the extent of their mystical tendencies,
Chiropractors talk of “subluxations”, an entirely imaginary phenomenon (but a cause of much unnecessary exposure to X-rays). Many talk of quasi-religious things like “innate energy”. And Chiropractic is even more riven by competing factions than acupuncture. See, for example, Chiropractic wars Part 3: internecine conflict.
The bait and switch trick
This is the basic trick used by ‘alternative therapists’ to gain respectability.
There is a superb essay on it by the excellent Yale neurologist Steven Novella: The Bait and Switch of Unscientific Medicine. The trick is to offer some limited and reasonable treatment (like back manipulation for low back pain). This, it seems, is sufficient to satisfy NICE. But then, once you are in the showroom, you can be exposed to all sorts of other nonsense about “subluxations” or “Qi”. Still worse, you will also be exposed to the claims of many chiropractors and acupuncturists to be able to cure all manner of conditions other than back pain. But don’t even dare to suggest that manipulation of the spine is not a cure for colic or asthma or you may find yourself sued for defamation. The shameful legal action of the British Chiropractic Association against Simon Singh (follow it here) led to an addition to DC’s Patients’ Guide to Magic Medicine.
(In the face of such tragic behaviour, one has to be able to laugh).
Libel: A very expensive remedy, to be used only when you have no evidence. Appeals to alternative practitioners because truth is irrelevant.
NICE seems to have fallen for the bait and switch trick, hook line and sinker.
The neglected consequences
Once again, we see the consequences of paying insufficient attention to the Dilemmas of Alternative Medicine.
The lying dilemma
If acupuncture is recommended we will have acupuncturists telling patients about utterly imaginary things like “Qi” and “meridians”. And we will have chiropractors telling them about subluxations and innate energy. It is my opinion that these things are simply make-believe (and that is also the view of a minority of acupuncturist and chiropractors). That means that you have to decide whether the supposed benefits of the manipulation are sufficient to counterbalance the deception of patients.
Some people might think that it was worth it (though not me). What is unforgivable is not to consider even the question. The NICE guidance says not a word about this dilemma. Why not?
The training dilemma
The training dilemma is even more serious. Once some form of alternative medicine has successfully worked the Bait and Switch trick and gained a toehold in the NHS, there will be an army of box-ticking HR zombies employed to ensure that they have been properly trained in “subluxations” or “Qi”. There will be quangos set up to issue National Occupational Standards in “subluxations” or “Qi”. Skills for Health will issue “competences” in “subluxations” or “Qi” (actually they already do). There will be courses set up to teach about “subluxations” or “Qi”, some even in ‘universities’ (there already are).
The respectability problem
But worst of all, it will become possible for aupuncturists and chiropractors to claim that they now have official government endorsement from a prestigious evidence-based organisation like NICE for “subluxations” or “Qi”. Of course this isn’t true. In fact the words “subluxations” or “Qi” are not even mentioned in the draft report. That is the root of the problem. They should have been. But omitting stuff like that is how the Bait and Switch trick works.
Alternative medicine advocates crave, above all, respectability and acceptance. It is sad that NICE seems to have given them more credibility and acceptance without having considered properly the secondary consequences of doing so,
How did this failure of NICE happen?
It seems to have been a combination of political correctness, failure to consider secondary consequences, and excessive influence of the people who stand to make money from the acceptance of alternative medicine.
Take, for example, the opinion of the British Pain Society. This organisation encompasses not just doctors. It
includes “doctors, nurses, physiotherapists, scientists, psychologists, occupational therapists and other healthcare professionals actively engaged in the diagnosis and treatment of pain and in pain research for the benefit of patients”. Nevertheless, their response to the draft guidelines pointed out that the manipulative therapies as a whole were over-represented.
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Manipulation The guidelines assess 9 large groups of interventions of which manual therapies are only one part. The full GDG members panel of 13 individuals included two proponents of spinal manipulation/mobilisation (P Dixon and S Vogel). In addition, the chair of the panel (M Underwood) is the lead author of the UKBEAM trial on which the positive recommendation for |
It seems that the Pain Society were quite right.
LBC 97.3 Breakfast Show (25 May 2009) had a quick discussion on acupuncture (play mp3 file). After I had my say, the other side was put by Rosey Grandage. She has (among other jobs) a private acupuncture practice so she is not quite as unbiassed as me). As usual, she misrepresents the evidence by failing to distinguish between blind and non-blind studies. She also misrepresented what I said by implying that I was advocating drugs. That was not my point and I did not mention drugs (they, like all treatments, have pretty limited effectiveness, and they have side effects too). She said “there is very good evidence to show they (‘Qi’ and ‘meridians’] exist”. That is simply untrue.
There can’t be a better demonstration of the consequences of falling for bait and switch than the defence mounted by Rosey Grandage. NICE may not mention “Qi” and “meridians”; but the people they want to allow into the NHS have no such compunctions.
I first came across Rosey Grandage when I discovered her contribution to the Open University/BBC course K221. That has been dealt with elsewhere. A lot more information about acupuncture has appeared since then. She doesn’t seem to have noticed it. Has she not seen the Nordic Cochrane Centre report? Nor read Barker Bausell, or Singh & Ernst? Has she any interest in evidence that might reduce her income? Probably not.
Where to find out more
An excellent review of chiropractic can be found at the Layscience site. It was written by the indefatigable ‘Blue Wode’ who has provided enormous amounts of information at the admirable ebm-first site (I am authorised to reveal that ‘Blue Wode’ is the author of that site). There you will also find much fascinating information about both acupuncture and about chiropractic.
I’m grateful to ‘Blue Wode’ for some of the references used here.