LOB-vs
Download Lectures on Biostatistics (1971).
Corrected and searchable version of Google books edition

Download review of Lectures on Biostatistics (THES, 1973).

Latest Tweets
Categories
Archives

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The new draft guidance on low back pain was released on 24 March 2016.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

Jump to follow-up

This is a very important book.

Buy it now (that link is to Waterstone’s Amazon don’t pay tax in the UK, so don’t use them).

When you’ve read it, do something about it. The book has lots of suggestions about what to do.

bg gif

Stolen from badscience.net

 

Peter Medawar, the eminent biologist, in his classic book Advice to a Young Scientist, said this.

 “Exaggerated claims for the efficacy of a medicament are very seldom the consequence of any intention to deceive; they are usually the outcome of a kindly conspiracy in which everybody has the very best intentions. The patient wants to get well, his physician wants to have made him better, and the pharmaceutical company would have liked to have put it into the physician’s power to have made him so. The controlled clinical trial is an attempt to avoid being taken in by this conspiracy of good will.”

There was a lot of truth in that 1979, towards the end of the heyday of small molecule pharmacology.  Since then, one can argue, things have gone downhill.

First, though, think of life without general anaesthetics, local anaesthetics, antibiotics, anticoagulants and many others.  They work well and have done incalculable good.  And they were developed by the drug industry.

But remember also that remarkably little is known about medicine.  There are huge areas in which neither causes nor cures are known.  Treatments for chronic pain, back problems, many sorts of cancer and almost all mental problems are a mess.  It just isn’t known what to do.  Nobody is to blame for this.  Serious medical research has been going on for little more than 60 years, and it turns out to be very complicated.  We are doing our best, but are still ignorant about whole huge areas. That leads to a temptation to make things up. Clutching at straws is very evident when it comes to depression, pain and Alzheimer’s disease, among others.

In order to improve matters, one essential is to do fair tests on treatments that we have.  Ben Goldacre’s book is a superb account of how this could be done, and how the process of testing has been subverted for commercial gain and to satisfy the vanities of academics.

Of course there is nothing new in criticisms of Big Pharma.  The huge fines levied on them for false advertising are well known.  The difference is that Goldacre’s book explains clearly what’s gone wrong in great detail, documents it thoroughly, and makes concrete suggestions for improving matters.

Big Pharma has undoubtedly sometimes behaved appallingly in recent years. Someone should be in jail for crimes against patients.  They have behaved in much the same way that bankers have. In any huge globalised industry it is always possible to blame someone in another department for the dishonesty.  But they aren’t the only people to blame.  None of the problems could have arisen with the complicity of academics, universities, and a plethora of regulatory agencies and professional bodies.

The biggest scandal of all is missing data (chapter 1).  Companies, and sometmes academics, have suppressed of trials that don’t favour the drugs that they are trying to sell.  The antidepressant drug, reboxetine, appeared at first to be good. It had been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and there was at least one good randomized placebo-controlled trial (RCT) showing it worked.  But it didn’t.  The manufacturer didn’t provide a complete list of unpublished trials when asked for them.  After much work it was found in 2010 that, as well as the published, favourable trial, there were six more trials which had not been published and all six showed reboxetine to be no better than placebo .  In comparisons with other antidepressant drugs three small studies (507 patients) showed reboxetine to be as good as its competitors.  These were published. But it came to light that data on 1657 patients had never been published and these showed reboxetine to be worse than its rivals.

When all the data for the SSRI antidepressants were unearthed (Kirsch et al., 2008) it turned out that they were no better than placebo for mild or moderate depression. This selective suppression of negative data has happened time and time again. It harms patients and deceives doctors, but, incredibly, it’s not illegal.

Disgracefully, Kirsch et al. had to use a Freedom of Information Act request to get the data from the FDA.

“The output of a regulator is often simply a crude, brief summary: almost a ‘yes’ or ‘no’ about side effects. This is the opposite of science, which is only reliable because everyone shows their working, explains how they know that something is effective or safe, shares their methods and their results, and allows others to decide if they agree with the way they processed and analysed the data.”

 

“the NICE document discussing whether it’s a good idea to have Lucentis, an extremely expensive drug, costing well over £ 1,000 per treatment, that is injected into the eye for a condition called acute macular degeneration. As you can see, the NICE document on whether this treatment is a good idea is censored. Not only is the data on the effectiveness of the treatment blanked out by thick black rectangles, in case any doctor or patient should see it, but absurdly, even the names of some trials are missing, preventing the reader from even knowing of their existence, or cross referencing information about them.Most disturbing of all, as you can see in the last bullet point, the data on adverse events is also censored.”

nice

 

The book lists all the tricks that are used by both industry and academics. Here are some of them.

  • Regulatory agencies like the MHRA, the European Medicines Agency (EMA) and the US Food and Drugs Administration (FDA) set a low bar for approval of drugs.
  •  Companies make universities sign gagging agreements which allow unfavourable results to be suppressed, and their existence hidden.
  • Accelerated approval schemes are abused to get quick approval of ineffective drugs and the promised proper tests often don’t materialise
  • Disgracefully, even when all the results have been given to the regulatory agencies (which isn’t always). The MHRA, EMA and FDA don’t make them public. We are expected to take their word.
  • Although all clinical trials are meant to be registered before they start, the EMA register, unbelievably, is not public.  Furthermore there is no check that the results if trials ever get published.  Despite mandates that results must be published within a year of finishing the trial, many aren’t.  Journals promise to check this sort of thing, but they don’t.
  • When the results are published, it is not uncommon for the primary outcome, specified before it started, to have been changed to one that looks like a more favourable result.  Journals are meant to check, but mostly don’t.
  • Companies use scientific conferences, phony journals, make-believe “seed trials” and “continuing medical education” for surreptitious advertising.
  • Companies invent new diseases, plant papers to make you think you’re abnormal, and try to sell you a “cure”.  For example, female sexual dysfunction , restless legs syndrome and social anxiety disorder (i.e. shyness).  This is called disease-mongering, medicalisation or over-diagnosis. It’s bad.
  • Spin is rife. Companies, and authors, want to talk up their results. University PR departments want to exaggerate benefits. Journal editors want sensational papers. Read the results, not the summary. This is universal (but particularly bad in alternative medicine).
  • Companies fund patient groups to lobby for pills even when the pills are known to be ineffective.  The lobby that demanded that Herceptin should be available to all on the breast cancer patients on the NHS was organised by a PR company working for the manufacturer, Roche.  But Herceptin doesn’t work at all in 80% of patients and gives you at best a few extra months of  life in advanced cases.
  • Ghostwriting of papers is serious corruption.  A company writes the paper and senior academics appear as the authors, though they may never have seen the original data.  Even in cases where academics have admitted to lying about whether they have seen the data, they go unpunished by their universities. See for example, the case of Professor Eastell.
  • By encouraging the funding of “continuing medical education” by companies, the great and the good of academic medicine have let us down badly.

This last point is where the book ends, and it’s worth amplification.

“So what have the great and good of British medicine done to help patients, in the face of this endemic corruption, and these systematic flaws? In 2012, a collaborative document was produced by senior figures in medicine from across the board, called ‘Guidance on Collaboration Between Healthcare Professionals and the Pharmaceutical Industry’. This document was jointly approved by the ABPI, the Department of Health, the Royal Colleges of Physicians, Nursing, Psychiatrists, GPs, the Lancet, the British Medical Association, the NHS Confederation, and so on. ”

“It contains no recognition of the serious problems we have seen in this book. In fact, quite the opposite: it makes a series of assertions about them that are factually incorrect.”

“It states that drug reps ‘can be a useful resource for healthcare professionals’. Again, I’m not sure why the Royal Colleges, the BMA, the Department of Health and the NHS Confederation felt the need to reassert this to the doctors of the UK, on behalf of industry, when the evidence shows that drug reps actively distort prescribing practices. But that is the battle you face, trying to get these issues taken seriously by the pinnacle of the medical establishment.”

This is perhaps the most shameful betrayal of all.  The organisations that should protect patients have sold them out.

You may have been sold out by your “elders and betters”, but you can do something. The “What to do” sections of the book should be produced as a set of flash cards, as a reminder that matters can be improved.

It is shameful that this book was not written by a clinical pharmacologist, or a senior doctor, or a Royal College, or a senior academic.  Why has the British Pharmacological Society said nothing?

It is shameful too that this book was not written by one of the quacks who are keen to defend the $60 billion alternative medicine industry (which has cured virtually nothing) and who are strident in their criticism of the 600 billion dollar Pharma industry.  They haven’t done the work that Goldacre has to analyse the real problems.  All they have done is to advocate unfair tests, because that is the only sort their treatments can pass.

It’s weird that medicine, the most caring profession, is more corrupt than any other branch of science.  The reason, needless to say, is money. Well, money and vanity.  The publish or perish mentality of senior academics encourages dishonesty. It is a threat to honest science.

Goldacre’s book shows the consequences: harm to patients and huge wastage of public money.

Read it.

Do something.

 

Follow-up

7 October, 2012, The Observer

Goldacre wrote

"I think it’s really disappointing that nobody, not the Royal Colleges, the Academy of Medical Sciences, the British Pharmacological Society, the British Medical Association, none of these organisations have stood up and said: selective non-publication of unflattering trial data is research misconduct, and if you do it you will be booted out. And I think they really urgently should."

Exactly.

This is a slightly-modified version of the article that appeared in BMJ blogs yesterday, but with more links to original sources, and a picture. There are already some comments in the BMJ.

The original article, diplomatically, did not link directly to UCL’s Grand Challenge of Human Wellbeing, a well-meaning initiative which, I suspect, will not prove to be value for money when it comes to practical action.

Neither, when referring to the bad effects of disempowerment on human wellbeing (as elucidated by, among others, UCL’s Michael Marmot), did I mention the several ways in which staff have been disempowered and rendered voiceless at UCL during the last five years. Although these actions have undoubtedly had a bad effect on the wellbeing of UCL’s staff, it seemed a litlle unfair to single out UCL since similar things are happening in most universities. Indeed the fact that it has been far worse at Imperial College (at least in medicine) has probably saved UCL from being denuded. One must be thankful for small mercies.

There is, i think, a lesson to be learned from the fact that formal initiatives in wellbeing are springing up at a time when university managers are set on taking actions that have exactly the opposite effect. A ‘change manager’ is not an adequate substitute for a vote.  Who do they imagine is being fooled?

BMJ blogs logo
Click logo to go to BMJ

The A to Z of the wellbeing industry
From angelic reiki to patient-centred care

Nobody could possibly be against wellbeing. It would be like opposing motherhood and apple pie. There is a whole spectrum of activities under the wellbeing banner, from the undoubtedly well-meaning patient-centred care at one end, to downright barmy new-age claptrap at the other end.  The only question that really matters is, how much of it works? 

Let’s start at the fruitcake end of the spectrum.

One thing is obvious. Wellbeing is big business. And if it is no more than a branch of the multi-billion-dollar positive-thinking industry, save your money and get on with your life.

In June 2010, Northamptonshire NHS Foundation Trust sponsored a “Festival of Wellbeing” that included a complementary therapy taster day. In a BBC interview one practitioner used the advertising opportunity, paid for by the NHS, to say “I’m an angelic reiki master teacher and also an angel therapist.” “Angels are just flying spirits, 100 percent just pure light from heaven. They are all around us. Everybody has a guardian angel.” Another said “I am a member of the British Society of Dowsers and use a crystal pendulum to dowse in treatment sessions. Sessions may include a combination of meditation, colour breathing, crystals, colour scarves, and use of a light box.” You couldn’t make it up.
 
The enormous positive-thinking industry is no better. Barbara Ehrenreich’s book, Smile Or Die: How Positive Thinking Fooled America and the World, explains how dangerous the industry is, because, as much as guardian angels, it is based on myth and delusion. It simply doesn’t work (except for those who make fortunes by promoting it). She argues that it fosters the sort of delusion that gave us the financial crisis (and pessimistic bankers were fired for being right). Her interest in the industry started when she was diagnosed with cancer.  She says

”When I was diagnosed, what I found was constant exhortations to be positive, to be cheerful, to even embrace the disease as if it were a gift. If that’s a gift, take me off your Christmas list,”

 It is quite clear that positive thinking does nothing whatsoever to prolong your life (Schofield et al 2004;   Coyne et al 2007; 2,3), any more than it will cure tuberculosis or cholera. “Encouraging patients to “be positive” only may add to the burden of having cancer while providing little benefit” (Schofield et al 2004). Far from being helpful, it can be rather cruel.

Just about every government department, the NHS, BIS, HEFCE, and NICE, has produced long reports on wellbeing and stress at work. It’s well known that income is correlated strongly with health (Marmot, M., 2004). For every tube stop you go east of Westminster you lose a year of life expectancy (London Health Observatory).  It’s been proposed that what matters is inequality of income (Wilkinson & Pickett, 2009). The nature of the evidence doesn’t allow such a firm conclusion (Lynch et al. 2004), but that isn’t really the point. The real problem is that nobody has come up with good solutions. Sadly the recommendations at the ends of all these reports don’t amount to a hill of beans. Nobody knows what to do, partly because pilot studies are rarely randomised so causality is always dubious, and partly because the obvious steps are either managerially inconvenient, ideologically unacceptable, or too expensive.

Take two examples:

Sir Michael Marmot’s famous Whitehall study (Marmot, M., 2004)  has shown that a major correlate of illness is lack of control over one’s own fate: disempowerment. What has been done about it? 

In universities it has proved useful to managers to increase centralisation and to disempower academics, precisely the opposite of what Marmot recommends.

As long as it’s convenient to managers they are not going to change policy. Rather, they hand the job to the HR department which appoints highly paid “change managers,” who add to the stress by sending you stupid graphs that show you emerging from the slough of despond into eternal light once you realise that you really wanted to be disempowered after all. Or they send you on some silly “resilience” course.

change diagram
Pyschobabble from UCL’s HR department

A second example comes from debt. According to a BIS report (Mental Capital and Wellbeing), debt is an even stronger risk factor for mental disorder than low income. So what is the government’s response to that? To treble tuition fees to ensure that almost all graduates will stay in debt for most of their lifetime. And this was done despite the fact that the £9k fees will save nothing for the taxpayer: in fact they’ll cost more than the £3k fees. The rise has happened, presumably, because the ideological reasons overrode the government’s own ideas on how to make people happy.

Nothing illustrates better the futility of the wellbeing industry than the response that is reported to have been given to a reporter who posed as an applicant for a “health, safety, and wellbeing adviser” with a local council. When he asked what “wellbeing” advice would involve, a member of the council’s human resources team said: “We are not really sure yet as we have only just added that to the role. We’ll want someone to make sure that staff take breaks, go for walks — that kind of stuff.”

The latest wellbeing notion to re-emerge is the happiness survey. Jeremy Bentham advocated “the greatest happiness for the greatest number,” but neglected to say how you measure it. A YouGov poll asks, “what about your general well-being right now, on a scale from 1 to 10.” I have not the slightest idea about how to answer such a question. As always some things are good, some are bad, and anyway wellbeing relative to whom?  Writing this is fun. Trying to solve an algebraic problem is fun. Constant battling with university management in order to be able to do these things is not fun. The whole exercise smacks of the sort of intellectual arrogance that led psychologists in the 1930s to claim that they could sum up a person’s intelligence in a single number.  That claim was wrong and it did great social harm.

HEFCE has spent a large amount of money setting up “pilot studies” of wellbeing in nine universities. Only one is randomised, so there will be no evidence for causality. The design of the pilots is contracted to a private company, Robertson Cooper, which declines to give full details but it seems likely that the results will be about as useless as the notorious Durham fish oil “trials”(Goldacre, 2008).

Lastly we get to the sensible end of the spectrum: patient-centred care. Again this has turned into an industry with endless meetings and reports and very few conclusions.  Epstein & Street (2011) say

“Helping patients to be more active in consultations changes centuries of physician-dominated dialogues to those that engage patients as active participants. Training physicians to be more mindful, informative, and empathic transforms their role from one characterized by authority to one that has the goals of partnership, solidarity, empathy, and collaboration.”

That’s fine, but the question that is constantly avoided is what happens when a patient with metastatic breast cancer expresses a strong preference for Vitamin C or Gerson therapy, as  advocated by the YesToLife charity. The fact of the matter is that the relationship can’t be equal when one party, usually (but not invariably) the doctor, knows a lot more about the problem than the other. 

What really matters above all to patients is getting better.  Anyone in their right mind would prefer a grumpy condescending doctor who correctly diagnoses their tumour, to an empathetic doctor who misses it. It’s fine for medical students to learn social skills but there is a real danger of so much time being spent on it that they can no longer make a correct diagnosis.  Put another way, there is confusion between caring and curing. It is curing that matters most to patients. It is this confusion that forms the basis of the bait and switch tactics (see also here) used by magic medicine advocates to gain the respectability that they crave but rarely deserve.

If, as is only too often the case, the patient can’t be cured, then certainly they should be cared for. That’s a moral obligation when medicine fails in its primary aim. There is a lot of talk about individualised care. It is a buzzword of quacks and also of the libertarian wing which says NICE is too prescriptive. It sounds great, but it helps only if the individualised treatment actually works.

Nobody knows how often medicine fails to be “patient-centred.”. Even less does anyone know whether patient-centred care can improve the actual health of patients. There is a strong tendency to do small pilot trials that are as likely to mislead as inform. One properly randomised trial (Kinmonth et al., 1998) concluded

“those committed to achieving the benefits of patient centred consulting should not lose the focus on disease management.”

Non-randomised studies may produce more optimistic conclusions (e.g. Hojat et al, 2011), but there is no way to tell if this is simply because doctors find it easy to be empathetic with patients who have better outcomes.

Obviously I’m in favour of doctors being nice to patients and to listening to their wishes. But there is a real danger that it will be seen as more important than curing. There is also a real danger that it will open the doors to all sorts of quacks who claim to provide individualised empathic treatment, but end up recommending Gerson therapy for metastatic breast cancer. The new College of Medicine, which in reality is simply a reincarnation of the late unlamented Prince’s Foundation for Integrated Health, lists as its founder Capita, the private healthcare provider that will, no doubt, be happy to back the herbalists and homeopaths in the College of Medicine, and, no doubt, to make a profit from selling their wares to the NHS.

In my own experience as a patient, there is not nearly as much of a problem with patient centred care as the industry makes out. Others have been less lucky, as shown by the mid-Staffordshire disaster (Delamothe, 2010),  That seems to have resulted from PR being given priority over patients. Perhaps all that’s needed is to save money on all the endless reports and meetings (“the best substitute for work”), ban use of PR agencies (paid lying) and to spend the money on more doctors and nurses so they can give time to people who need it.  This is a job that will be hindered considerably by the government’s proposals to sell off NHS work to private providers who will be happy to make money from junk medicine.

Reference

Wilkinson. R & Pickett, K.  2009 , The Spirit Level, ISBN 978 1 84614 039 6


A footnote on Robertson Cooper and "resilience"

I took up the offer of Robertson Cooper to do their free "resilience" assessment, the company to which HEFCE has paid an undisclosed amount of money.

guff

The first problem arose when it asked about your job. There was no option for scientist, mathematician, university or research, so I was forced to choose "education and training". (a funny juxtaposition since training is arguably the antithesis of education). It had 195 questions. mostly as unanswerable as in the YouGov happiness survey. I particularly liked question 124 "I see little point in many of the theoretical models I come across". The theoretical models that I come across most are Markov models for the intramolecular changes in a receptor molecule when it binds a ligand (try, for example, Joint distributions of apparent open and shut times of single-ion channels and maximum likelihood fitting of mechanisms). I doubt the person who wrote the question has ever heard of a model of that sort. The answer to that question (and most of the others) would not be worth the paper they are written on.

The whole exercise struck me as the worst sort of vacuous HR psychobabble. It is worrying that HEFCE thinks it is worth spending money on it.

Follow-up

Jump to 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 on

Time 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  http://www.dcscience.net/?p=257
(A.J. Clark FRS was professor of Pharmacology at UCL from 1919 to 1926, and subsequently in Edinburgh).

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
   The ‘competences’ have been revised since the account at http://www.dcscience.net/?p=215#sfh, but are still preposterous make believe.

9. A very bad report: gamma minus for the vice-chancellor

10. A Patients’ Guide to Magic Medicine,  and also in the Financial Times.

11.  An excellent submission to the consultation on statutory regulation of alternative medicine (Pittilo report)

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
Jane Symons.  The Sun 2 December 2009. 

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 2009Daily 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”. http://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..

Jump to follow-up

Peter Dixon is a chiropractor. He is chair of the General Chiropractic Council (GCC). He was also a member of the hotly-disputed NICE low back pain guidance group that endorsed (you guessed it) the use of chiropractic, a decision that has led to enormous criticism of the standards of the National Institute of health and Clinical Excellence (NICE).

As a consequence largely of the decision of the British Chiropractic Association (BCA) to sue Simon Singh for defamation, there has been an unprecedented interest taken in the claims made by chiropractors in general.

Peter Dixon has a problem because something like 600 individual complaints about unjustified health claims have been sent to the GCC. Even when a web site does not claim to be able to benefit things like asthma and colic, a phone call may reveal that claims are made in private (one of the many complaints to the GCC concerns such behaviour by two practices belonging to, ahem, Peter Dixon Associates).

The crucial question is, as always, one of evidence. The BCA claim to have a plethora of evidence for their claims, but they have been strangely reluctant to produce it. In fact evidence is cited on the “Your first visit” page on Dixon’s site.

first visit

At the bottom we see “How effective is Chiropractic?”.

Meade paper

That sounds very impressive indeed: . ” . . . patients who received chiropractic treatment improved by 70% more than those given hospital out-patient.”

But hang on. If we look at the paper, Meade et al., 1990 [download reprint], we see that Figure 2 looks like this.

Meade 1990 Fig 2

Several things jump out. First, the Oswestry disability index scale runs for 0 to 100, but scores are plotted only from 0 to 35, so the size of the effects are exaggerated. Second, there are no error bars on the points. Third there is essentially no advantage for chiropractic at all when all patients are taken together (top graph). Fourth, and most important, the patients who were followed up for two years (bottom graph) seem to show a slight advantage for chiropractic but on average, the effect is 7 percent (on the 100 point scale, NOT 70 percent as claimed on the web site of Peter Dixon Associates.

What sort of mistake was made?

The abstract of the paper itself says “A benefit of about 7% points on the Oswestry scale was seen at two years.” How did this become “improved by 70% more”?

It could have been simple a typographical error, but that seems unlikely, Who’d boast about a 7% improvement?

Perhaps it is a question of relative versus absolute change. The Figure does not show the actual scores on the 100 point scale, but rather the change in score, relative to a questionnaire given just before starting treatment. If we look at the lower part of the Figure, restricted to those patients who stayed with the trail for 2 years (by this time 28% of the patients had dropped out), we see that there is a reduction in score (improvement) of about 10 points on the 100 point scale with hospital treatment (not a very impressive response). The improvement with those sent to private chiropractic clinics was about seven points bigger. So a change from 10 to 17 is a 70 percent change. What’s wrong with that?

What’s wrong is that it is highly misleading, as relative changes often are. Imagine that the hospital number had been 7 points and the chiropractic number had been 14 (both out of 100). That would mean that both treatments had provided very modest benefits to the patients. Would it then be fair to describe the chiropractic patients as have improved by 100 percent more than the hospital patients, when in fact neither got much benefit? Of course it would not. To present the results in this way would be highly deceptive.

Put another way, a 70% increase in a trivial effect is still pretty trivial.

That isn’t all either. The paper has been analysed in some detail on the ebm-first site. The seven point difference on a 100 point scale, though it may be real, is too small to be ‘clinically significant’ In other words the patient would scarcely notice such a small change. Another problem lies in the nature of the comparison. Patients were, quite properly, allocated at random to chiropractic or to to hospital treatment. BUT the comparion was very from blind. one group was treated in hospital. The other group was sent to private chiropractic clinics. The trivial 7 point difference could easily be as much to do with the thickness of the carpets rather than any effect of spinal manipulation.

What this paper really tells you is that neither treatment is very effective and that there is little to choose between them.

It is really most unfortunate that the chairman of the GCC should show himself to be so careless about evidence at a time when the evidence for the claims of chiropractors is under inspection as never before. It does not add to their case for criticising Simon Singh and it does not add to one’s confidence in the judgement of the NICE guidance group.

free debate

Follow-up

The Pain Society revolt. A letter has been sent from several distinguished members of the British Pain Society to its President and Council.

“We, the undersigned, call upon the President of the British Pain Society to issue a statement to NICE and to the press condemning outright the conclusions of the recent UK National Institute for Health and Clinical Excellence (NICE) guidelines . . .”

The sigificance of this letter is that the present president of the British Pain Society is Professor Paul Watson who was a member of the NICE guidance group that produced the recommendations which have engendered such criticism. He was clinical advisor to the guidance group. There is a video of Paul Watson talking about back pain, that seems to me to illustrate very well the problem with the guidance. He says it is a huge problem (everyone knows that) and that something must be done, but he doesn’t say what. There is no admission that, in very many cases, nobody knows what to do. It is exactly this sort of hubris that that makes the NICE report so bad,

One caustic comment on the letter says

“We are led by a physiotherapist! A Professor who cannot even interpret straight forward evidence when it is presented to him on a plate.
Who’s going to be the next BPS President? A Hospital Porter?”

Jump to 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.

Published 9 June 2009, doi:10.1136/bmj.b2333
Cite this as: BMJ 2009;338:b2333

Letters

Homoeopathic product licence

MHRA label seems to be illegal

The 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

  1. Cohen D. Drugs agency grants its first licence to homoeopathic product. BMJ 2009;338:b2055. (20 May.)

    [Free Full Text]

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.

Jump to follow-up

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]

Jump to follow-up

Two days ago I wrote NICE falls for Bait and Switch by acupuncturists and chiropractors: it has let down the public and itself

Now the official ‘guidance’ is out, and it is indeed quite as bad as the draft.

The relevant bits now read thus.

  • Offer one of the following treatment options, taking into account patient preference: an exercise programme, a course of manual therapy or a course of acupuncture. Consider offering another of these options if the chosen treatment does not result in satisfactory improvement.
  • Consider offering a structured exercise programme tailored to the person:
    • This should comprise of up to a maximum of 8 sessions over a period of up to 12 weeks.
    • Offer a group supervised exercise programme, in a group of up to 10 people.
    • A one-to-one supervised exercise programme may be offered if a group programme is not suitable for a particular person.
  • Consider offering a course of manual therapy, including spinal manipulation, comprising up to a maximum of nine sessions over a period of up to 12 weeks
  • Consider offering a course of acupuncture needling comprising up to a maximum of 10 sessions over a period of up to 12 weeks.

The summary guidance still doesn’t mention chiropractic explicitly, just a coy reference to “spinal manipulation”. At a time when the British Chiropractic Association is busy trying to suppress free speech via the law courts, I guess it isn’t surprising that they don’t like to use the word.

The bias in the recommendations is perhaps not surprising because the guidance development group had a heavy representation from alternative medicine advocates, and of people with a record of what, is, in my view, excessive tolerance of mumbo-jumbo.

Royal College of General Practitioners (RCGP) played a large part in writing the guidance. That is an organisation thar has steadfastly refused to make any sort of sensible statement of policy about magic medicine.   It isn’t long since I was told by a senior person at the RCGP that there was nothing odd about neuro-linguistic programming. That does not bode well.

Professor Martin Underwood, Professor of Primary Care Research Warwick Medical School, University of Warwick. Underwood chaired the guidance development group. Martin Underwood is also a GP in Coventry See also the British Osteopathic Association. Underwood was lead author of the BEAM trial (download reprint). It is well worth reading the comments on this trial too. It was a randomised trial (though not, of course, blind).

Our main aim was to estimate, for patients consulting their general practitioner with back pain, the effectiveness of adding the following to best care in general practice: a class based exercise programme (“back to fitness”), a package of treatment by a spinal manipulator (chiropractor, osteopath, or physiotherapist), or manipulation followed by exercise

Conclusions
Relative to “best care” in general practice, manipulation followed by exercise achieved a moderate benefit at three months and a small benefit at 12 months; spinal manipulation achieved a small to moderate benefit at three months and a small benefit at 12 months; and exercise achieved a small benefit at three months but not 12 months.

In other words, none of them worked very well. The paper failed to distinguish between manipulation by physiotherapists, chiropractors and osteopaths and so missed a valuable chance to find out whether there is an advantage to employing people from alternative medicine (the very problem that this NICE guidance should have dealt with)

Steve Vogel, another member of the guidance development group, is an osteopath. Osteopathy has cast off its shady origins better than chiropractic, but it remains a largely evidence-free zone, and is still usually classified as alternative medicine.

Peter Dixon DC FCC FBCA is chairman of the General Chiropractic Council and founder of Peter Dixon Associates. They run six chiropractic clinics. The claims made by these clinics on their web site are mostly related to musculo-skeletal conditions (not, all spine-related however). But they also include

“Chiropractic is also suitable for relieving the symptoms of stress, and optimizing the way the body works is one of the best ways of enhancing health and wellbeing.”

I wonder how they could justify that claim? Then we get

A chiropractor is always willing to discuss individual conditions or answer questions in order to assess whether chiropractic may be of benefit.

Thanks for the invitation. I accepted it. After the first two phone calls, I had learned all I needed.

The first of Peter Dixon’s clinics that I called, was asked about my son who was suffeiing from perpetual colic.  I asked for advice. I was put through to the chiropractor. Here are some extracts from the conversation.

“I think now it’s termed irritable baby syndrome. . . . . We’ve found chiropractic is very effective for colic . . . . £50 up to 3/4 hour which would involve taking a case history, examining the baby, with regard to seeing how the joints in the spine work because often colic is down to, er um, faulty movement patterns in the spine. We deal with an awful lot of things to do with the frame -how the spine moves -and it’s often problems with the way that the bones of the spine move in infants and babies that is the underlying cause in colicky symptoms. . . usually on the whole, I’ve shot myself in the foot by saying this in the past, if there are -um when I say back problems they’re usually temporary issues -when they are there the response for most babies is quite quick . . . it depends on how it’s related to what’s gone on in the birth process -there is usually some traumatic cause and it usually sets up a problem in the upper neck or the mid-back and that will drive those colic symptoms. . . . Yes it’s quite a straightforward thing we just check the baby’s spine and see if it’s problem we can deal with or not.”

Yes, I think you just shot yourself in the foot again. I have no idea in what fraction of cases a chiropractor would fail to claim that it was a case that they could deal with. At least that possibility was envisaged. But when I asked where he’d refer me to in such case I was told it might be a result of bottle feeding -“what they consume”. So I expect it would have been sent to some sort of “nutritional therapist” who would have used one of their usual battery of unreliable tests for food allergies.

I tried a second clinic in Peter Dixon’s empire and asked if chiropractic could help with asthma.”It can do, depending on what type of asthma you have".    After some questions I was asked

“Do you have any general aches and pains otherwise, any tension .problems round the rib cage or thoracic spine . . . There are two things we’d look as chiropractors as to whether we could help or not and that would include the tension round the rib cage -in any type of asthma you’ll become tight round the rib cage and merely by keeping that area loose you’d help to stop the asthma from becoming quite as bad. And the second part is we’d look at the neck area with you to see if there is any restriction there -which houses the nerve supply to the lungs which can be indicated in some asthma cases also.”

I was invited to come for a free screen, so I asked if it usually worked quickly, “It depends what the problem is but you’d need a course I suspect”.  £45 for the first appointment then £28 per session. “In most cases you’d need to look at a six to eight session course”.

Would anyone with experience of crying babies or of asthma like to comment on these proposed treatments? They are not my idea of evidence-based treatments and I find it quite surprising that someone who sponsors them is thought appropriate to write guidance for NICE.

This sort of ‘sting’ always makes me feel a bit uneasy, but it seems to be the only way to find out what actually goes on. And what goes on has all the appearance of classic bait and switch. You go in for your backache, and before you know where you are you are being sold a course of treatment to stop your baby crying.

Media follow-up after the NICE announcement

Sadly, I heard that the Today programme (my favourite news programme) was pretty wet. if only their science reporting was as good as their politics reporting.

The 27th May was certainly pretty busy for me, Apart from a couple of local paper interviews, this is what happened,

Sky News TV. Richard Suchet and two cameraman came to UCL and filmed a lot of stuff out of which a 20 second clip was used. And then they grumble that they don’t make money.

BBC TV 6 o’clock News. Similar, but at least only two people this time. Both TV stations spent ages showing pictures of people having needles pushed into them and very little time discussing the problems. A pathetically bad attempt at science reporting. Radio, on the whole, did much better

BBC Three Counties Radio (09.20) Host Ronnie Barbour, The daytime talk shows may be appalling to some of us, but the hosts did a far better job of airing the problems than TV [download the mp3].

Radio 5 Live Victoria Derbyshire [download the mp3]

BBC Radio Sheffield (12.05) was the best talk show by far.  First speaker was Steve Vogel, the osteopath from the guidance development group. Although invited by the rather sensible host, Rony, to respond to the idea that a secondary consequence of the guidance would be to introduce hocus-pocus, he steadfastly refused to answer the question. At the end a rather sensible GP summed up the view from the coalface. [play the mp3]

Radio 4 PM programme This excellent early evening news programme is run by Eddie Mair. It was the best interview yet. The other side was put by Martin Underwood, chair of the guidance development group [play the mp3]

Underwood said “the evidence shows that it [acupuncture] works”. I disagree. The evidence shows that acupuncture, in a non-blind comparison with no acupuncture shows a small, variable additional effect that doesn’t last and is of marginal clinical significance, That is not what I call “works”. Underwood then indulges in the subgroup analysis fallacy by asserting that a few people get a large benefit from acupuncture. Or perhaps a few people just happen to get better that day. I was not convinced.

More 4 News TV 20.20 was an interview, with the other side being put by my old friend, George Lewith.

During the introduction, an acupuncturist. Lisa Sherman, ‘explained’ acupuncture in the usual sort of utterly meaningless words that illustrate perfectly the problem.

George Lewith said that “we don’t have a good pretend form of acupuncture”. “We don’t have a good placebo and we can demonstrate that acupuncture is literally twice as effective as conventional care”. The first is simply nonsense: huge efforts have gone into developing good controls in acupuncture studies (see, for example, Barker Bausell’s book, Snake Oil Science). And I hope that George will send the references for his “twice as effective” claim. It seems to me to be nothing short of preposterous.

My conclusions

So what went wrong?

One problem could be regarded as medical arrogance. The fact is that the problem of low back pain has not been solved, either by drugs or anything else. It is a failure of medicine (and of pharmacology). That should be the premise of all discussions, and it smacks of arrogance not to tell people straight out. Of course there are some cases when causes can be identified, and perhaps remedied, usually by surgery, but these are the exceptions not the rule.

One consequence of the inability of medicine to help much is that patients get desperate, and willing to try anything. And of course if they happen to have a remission, that is attributed to the treatment, however preposterous that treatment may have been. Conditions like back pain that come and go unpredictable are a gift for quacks.

Another consequence, for researchers rather than patients, is to clutch at straws. Even small and inconsistent effects are seized on as ‘successes’. This phenomenon seems to be part of the reason for the NICE guidance. Another reason is, almost certainly, the grinding of axes by some of the people who wrote it.

What should be done now?

Professor Sir Michael Rawlins is a sensible chap. He cares about evidence, But it does seem that in this case, he might have taken his eye off the ball, for once. In my opinion, he should restore the reputation of NICE by withdrawing this guidance and starting again.

Follow-up

An interesting document has come my way. It shows the responses of the guidance group to the consultation on the draft guidance. Many people made comments not unlike mone, but they were all brushed aside in a way that looks to me rather partisan. The document appears to have vanished from NICE’s web site, but you can download it here.

Friday 29th May. The Times prints a letter from two consultants in pain medicine, Joan Hestor and Stephen Ward. It says, inter alia

“As experienced pain specialists we feel that NICE has lost its way in publishing these guidelines.”

“We are saddened that NICE has chosen to ignore our important role and promote seemingly unworkable and for the most part clinically ineffective treatments”

Friday 29th May. NICE has had a good reputation in the USA for its important, and usually high-quality, attempts to assess what works and what doesn’t. That makes it all the sadder to see it condemned already from the USA for its latest effort. The excellent Yale neurologist, Steven Novella, has written about it on his Neurologica blog.

Friday 29th May. A correspondent points out that the costings of the guidance can be found on the NICE web site. Table 1 has a strong air of make-believe.

The Daily Mail (29 May 2009). Their article quotes serious criticisms of NICE.

Dr Ron Cooper, past chairman of the group and a consultant pain specialist in Northern Ireland, said: ‘I have never known so many pain medicine specialists to be so furious. More patients will end up having more expensive surgery, which is unnecessary, risky and has worse results.

‘NICE made it difficult for us to submit evidence to a committee on which there was not one experienced pain physician.

‘The guidelines will make us the laughing stock of Europe, Australia and the U.S. where pain specialists will continue to have full access to a wide range of treatments.’

Chirowatch suspended.  30 May 2009.  The invaluable chiro-watch site, http://www.chirowatch.com, run by Dr Canadian physician, Dr Tom Polevoy, has been “suspended”. In fact the whole of his domain, healthwatcher.net, has been disabled. It seems that this was the result of a legal threat to his ISP, not by chiropractors this time, but by William O’Neill of the Canadian Cancer Research Group, which is far from being what the respectable-sounding title suggests, according to Dr Stephen Barrett. The site will be back soon, I’m told. Meanwhile you can read the suspended page here, and the only result of their hamfisted bullying will be to vastly increase the number of people who read it. You can read lots more at Quackwatch’s chirobase and at ebm-first.

A new blog, Not as NICE as you think appeared on May 30th. It is written by a pain physician, Stephen Ward. and is devoted to pointing out the serious problems raised by NICE’s guidance. It starts with the (very critical) World Institute of Pain Press Release.

British Medical Journal has more flak for the NICE guidelines

And the BMJ has published a letter signed by 50 consultants in pain medicine, NICE guidelines on low back pain are flawed.(this will probably appear as a letter in the print edition of the BMJ).

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.

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
manipulation/mobilisation seems to predominately rest. Proponents of spinal manipulation/mobilisation were therefore over-represented in the generation of these guidelines, which, in turn could have generated the over-optimistic conclusion regarding this intervention.

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.

Follow-up

Recent Comments