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A flood of complaints against chiropractors has arrived at the General Chiropractic Council (GCC) in the wake of the British Chiropractic Association (BCA) v Singh affair. It is really rather beautiful that people have put some such enormous effort into writing complaints for no gain to themselves.

My own paltry two complaints to the GCC produced an interesting reaction. Yesterday I was told by the GCC

“Under the provisions of the General Chiropractic Council (Investigating Committee) Rules

2000 (“the Rules”), the Committee is required to invite you to make a statement of evidence in relation to your complaint by way of statutory declaration or affidavit. If you wish to, you can discuss your complaint with a solicitor who acts on behalf of the Committee who could help you draft a statement of evidence that meets the requirements of the Rules. The General Chiropractic Council will pay for the Investigating Committee solicitor’s costs and will reimburse you for any fee you subsequently pay for having your witness statement sworn at a location convenient to you.”

Naturally I shall take up this offer. If the same offer is made to everyone who complained (must be approaching 600), the legal fees incurred by the GCC would presumably be enough to bankrupt them. No wonder they are wriggling.

Here is a letter sent by the GCC’s Chief Executive and Registrar, Margaret Coats, a couple of days ago. It reached me by more than one route, but it is already on the web anyway, on Richard Lanigan’s site, Told you the General Chiropractic Council would find a way to dismiss the complaints. “Protecting the public” my arse! Protecting themselves more like it.. (The GCC has been under attack from within for some time, though mainly because some chiropractors think it regulates too much, not too little)

The bit that is especially interesting is para 2

In quangos like the GCC, complaints don’t necessarily get considered at all. First they go to an investigating committee (IC) which has to decide if there is a ‘case to answer’. Now the GCC wants that criterion to be changed to ‘realistic prospect of success’. Given the GCC’s attitude to evidence it is hard to imagine that any complaint will have a ‘realistic prospect of success’.

The second idea is even more grotesque. The GCC want to be able to dismiss without consideration rafts of complaints where in their opinion, referral to the Professional Conduct Committee (PCC) ‘is not required in the public interest. Or, more likely, not required in the interests of the GCC.

Will the Privy Council acquiesce in this disgraceful attempt to evade complaints? Wel, until January 2008, Graham Donald was a senior civil Servant at the Privy Council bit he now works for the GCC. That must help.

The GCC has been contacted by several Trading Standards Offices too, after complaints made to them about chiropractors. . A response was sent by the GCC on 5 June [download the whole response]. It includes

“It is important to emphasise that the GCC doesn’t claim that chiropractors ‘treat’ asthma, headaches (including migraine) and infant colic. It is possible that chiropractic care may help to alleviate the symptoms of some of these conditions.”

What on earth is that meant to mean?

One hopes that Trading Standards officers are too smart to be taken in by weasel words like that.

The attitude of the GCC to evidence is amply illustrated by the fact that they have said that the rather crude myths known as craniosacral therapy and applied kinesiology fall within their definition of evidence-based care.

Any organisation that can say that is clearly incompetent.

### 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.

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

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.

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.

### 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?”

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

## 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.)

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.

That isn’t my title. It is the title of a post by Richard Lanigan, with whom I’ve been corresponding. He has a major grudge against the General Chiropractic Council. And in particular he is disaffected about the GCC’s chair, Peter Dixon, about whom he has written a lot, I can’t judge the details of his complaints, but they are laid out in detail on his blog, http://chiropracticlive.com/

Particular interest attaches to his recent revelation of a letter that was sent on July 8th to its members by the McTimoney Chiropractic Association. The McTimoney sect of chiropractic are the ‘true believers’ in the most mystical codswallop aspects of the subject. Oddly enough their College has been validated by the University of Wales, I’ve put in a Freedom of Information Act reguest to the University of Wales to see how that happened. Watch this space.

My interpretation of this letter is that it is as near as you can get to an admission, by chiropractors themselves, that many chiropractors make claims that are against the law. And worse still, that the McTimoney Chiropractic Assocation is well aware of that.

News travels fasts in the blogosphere. This item has already appeared today on The Quackometer, The Lay Scientist and Gimpy and on Zeno’s blog. Let’s hope that the news spreads far and wide.

### Follow-up

The deleted pages are here. Thanks again to quackometer, here is where you can see the pages that might have been taken down as a result of McTimoney’s letter. I hope they won’t grumble. Really, they sjould never have put them up if they weren’t true, should they?.

 Simon Singh is a great science writer and communicator. He is author of The Big Bang, The Code Book, Fermat’s Last Theorem, and, with Edzard Ernst, Trick or Treatment. They are superb books (buy from Amazon).

When Singh had the temerity to express an honest opinion, based on the evidence, about that very curious branch of alternative medicine known as chiropractic, the British Chiropractic Association sued Singh for defamation.This was their substitute for producing evidence for their bizarre claims.

Chiropractors seem to be particularly fond of litigation, perhaps because they are so short of evidence. Having had legal threats from them myself, I know how scary it can be, Luckily I was saved by a feisty a journal editor.  Singh wasn’t so lucky.  The history is recounted here,

The legal aspects of the case are being described by the lawyer who writes under the name of Jack of Kent. He has regular updates on progress.

Put briefly, Libel: A very expensive remedy, to be used only when you have no evidence. Appeals to alternative practitioners because truth is irrelevant

The iniquitous nature of England’s libel law has been described eloquently by Nick Cohen, in the Observer. It is used regularly by rogues and criminals from all over the world to silence their critics. All they need is money. Truth is irrelevant. It is a disgrace to a civilised country.

The cost of defamation cases in the UK is vastly greater than in any other country in Europe:: look at the graph.

With enormous courage, Simon Singh has decided to appeal against the ruling by Mr Justice Eady. Scientists and journalists everywhere should rally to support him, if they value the right to express an honest opinion without being bankrupted by a law court. Singh is taking a great risk on behalf of anyone who values freedom of speech.

The charity, Sense abour Science (SaS), has started a campaign to Keep the Libel Laws out of Science.

Read the statement about the campaign on the SaS site, and the current list of signatories. The list of supporters is already very impressive. It includes, for example, professor Lord (Martin) Rees, president of the Royal Society and Astronomer Royal, to Dr Philip Campbell Editor-in-Chief of Nature, David Starkey Historian, Stephen Fry Broadcaster and Author and Baroness Helena Kennedy QC Barrister.

You can sign the statement yourself there. Do it. Now!

You can also get code for the button (above) to link your own web site to the campaign.

In 1894, a local Iowa newspaper, The Davenport Leader, wrote of the founder of chripractic, D.D. Palmer, thus.

“A crank on magnetism has a crazy notion hat he can cure the sick and crippled with his magnetic hands. His victims are the weak-minded, ignorant and superstitious, those foolish people who have been sick for years and have become tired of the regular physician and want health by the short-cut method he has certainly profited by the ignorance of his victim. His increase in business shows what can be done in Davenport, even by a quack.” [quoted in Rose
Shapiro’s book, Suckers
]

Today, in the UK, no newspaper would dare to express an opinion like that.

We all hope that Singh will win the appeal.  But even if he doesn’t win in the law courts, he will have scored an enormous moral victory.  What’s more, chiropractic is now under scrutiny as never before.  There is going to be a chiro-fest that will make the British Chiropractic Association rue the day that it decided to use legal bullying in place of reason.

They may even have signed their own death warrant.

Follow up will be posted here regularly

### Follow-up

There is a good roundup of activity up to June 3rd here.

The Wall Street Journal (June 4th) discusses the case under the title Britain Chills Free Speech.

British Medical Journal editorial by Evan Harris (Lib dem member of parliament and doctor), Science in Court

Bait and switch. Oh dear, oh dear. Just look at 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]

On 23rd May 2009, the Financial Times magazine published a six-page cover story about pseudo-scientific degrees by Richard Tomkins. The online version has the text but doesn’t do justice to the prominence that it was given. The print version had a much better title too, The Retreat from Reason. This article, which was some time in gestation, appeared shortly afte the last degree in homeopathy in the UK closed its doors. So perhaps it should have been called The Return of Reason. What’s interesting is that it has become commonplace for the mainstream newspapers to print articles like this and to dump some of their whackier lifestyle articles.

The print version had a much better title too, The Retreat from Reason, with a two-page spread..

They published the entire ‘Patients’ Guide to Magic Medicine‘ as a sidebar on page 4.

To these has now been added, inspired by Jack of Kent,

Libel: A very expensive remedy, to be used only when you have no evidence. Appeals to alternative practitioners because truth is irrelevant

One part of the article that I particularly enjoyed is this.

George Lewith, professor of health research at the University of Southampton’s medical school, is also director of the Centre for Complementary and Integrated Medicine, a private practice with ­clinics in Southampton and London’s West End, so it is no surprise that he is ready to speak out in support of complementary therapies. In fact, Southampton University – a member of the elite Russell Group – does not offer degree courses in complementary medicine, but Lewith defends the idea of offering them in principle, on the basis that, done properly, they produce better-trained practitioners. “Without the new universities’ involvement we might be faced with the quackery we saw in the 1940s and 1950s, when these people were outside medicine and were practising in an alternative fringe culture,” he says.

Sorry George, you are still an “alternative fringe culture”. And universities are realising that, and shutting down courses all over the place.

### A response in the Finacial Times

The FT published one response in its letter column, A bilious attack on complementary medicine.

“Sir, Like many journalists, Richard Tomkins has been over-impressed by the scientific credentials of Professors David Colquhoun and Edzard Ernst as they carry on their absurdly over-stated, arrogant and irresponsible campaign against complementary medicine (“The retreat of reason”, May 23)”

and then the trump card

“Absence of evidence is not evidence of absence”

That’s the line used by quacks again and again and again (see, for example, integrative baloney @ Yale). I guess they have never heard of type 1 and type 2 errors. But that is a bit technical for homeopaths, so put it more simply. There is a quite remarkable absence of evidence for tooth fairies. So they must exist. Get it?

The letter is from Allen Parrott of Yeovil. Could that be the Allen Parrott of the British Acupuncture Accreditation Board? If so he is “is an adult educationist who was Dean of Adult and Community Education at Yeovil College and a lecturer in the School of Education at Exeter University. As well as his work for the Board, he is currently working as an educational adviser for the Kent, Surrey and Sussex Deanery in the NHS.”. So no reason to worry about the standards of education in Yeovil, then.

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]

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].

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

 The Prince of Wales’ Foundation for Integrated Health (FiH) is a propaganda organisation that aims to persuade people, and politicians, that the Prince’s somewhat bizarre views about alternative medicine should form the basis of government health policy. His attempts are often successful, but they are regarded by many people as being clearly unconstitutional.

The FiH’s 2009 AnnualConferen ce conference was held at The King’s Fund, London 13 – 14 May 2009. It was, as always, an almost totally one-sided affair devoted to misrepresentation of evidence and the promotion of magic medicine.  But according to the FiH, at least, it was a great success.  The opening speech by the Quacktitioner Royal can be read here. It has already been analysed by somebody who knows rather more about medicine than HRH.    He concludes

“It is a shocking perversion of the real issues driven by one man; unelected, unqualified and utterly misguided”.

We are promised some movie clips of the meeting. They might even make a nice UK equivalent of “Integrative baloney @ Yale“.

This post is intended to provide some background information about the speakers at the symposium. But let’s start with what seems to me to be the real problem. The duplicitous use of the word “integrated” to mean two quite different things.

### The problem of euphemisms: spin and obfuscation

One of the problems of meetings like this is the harm done by use of euphemisms.   After looking at the programme, it becomes obvious that there is a rather ingenious bit of PR trickery going on.  It confuses (purposely?) the many different definitions of the word “integrative”  . One definition of “Integrative medicine” is this (my emphasis).

” . . . orienting the health care process to engage patients and caregivers in the full range of physical, psychological, social, preventive, and therapeutic factors known to be effective and necessary for the achievement of optimal health.”

That is a thoroughly admirable aim. And that, I imagine, is the sense in which several of the speakers (Marmot, Chantler etc) used the term.  Of course the definition is rather too vague to be very helpful in practice, but nobody would dream of objecting to it.

But another definition of the same term ‘integrative medicine’ is as a PR-friendly synonym for ‘alternative medicine’, and that is clearly the sense in which it is used by the Prince of Wales’ Foundation for Integrated Health (FIH), as is immediately obvious from their web site.
The guide to the main therapies supports everything from homeopathy to chiropractic to naturopathy, in a totally uncritical way. Integrated service refers explicitly to integration of ‘complementary’ medicine, and that itself is largely a euphemism for alternative medicine. For example, the FIH’s guide to homeopathy says

“What is homeopathy commonly used for?

Homeopathy is most often used to treat chronic conditions such as asthma; eczema; arthritis; fatigue disorders like ME; headache and migraine; menstrual and menopausal problems; irritable bowel syndrome; Crohn’s disease; allergies; repeated ear, nose, throat and chest infections or urine infections; depression and anxiety.”

But there is not a word about the evidence, and perhaps that isn’t surprising because the evidence that it works in any of these conditions is essentially zero.

The FIH document Complementary Health Care: A Guide for Patients appears to have vanished from the web after its inaccuracy received a very bad press, e.g. in the Times, and also here.   It is also interesting that the equally widely criticised Smallwood report (also sponsored by the Prince of Wales) seems to have vanished too).

The programme for the meeting can be seen here, for Day 1, and Day 2

Conference chair Dr Phil Hammond, GP, comedian and health service writer. Hammond asked the FIH if I could speak at the meeting to provide a bit of balance. Guess what? They didn’t want balance.

09:30 Opening session

### Dr Michael Dixon OBE

09:30   Introduction: a new direction for The Prince’s Foundation for Integrated Health and new opportunities in integrated health and care. Dr Michael Dixon, Medical Director, FIH

Michael Dixon is devoted to just about every form of alternative medicine. As well as being medical director of the Prince’s Foundation he also runs the NHS Alliance. Despite its name, the NHS Alliance is nothing to do with the NHS and acts, among other things, as an advocate of alternative medicine on the NHS, about which it has published a lot.

Dr Dixon is also a GP at College Surgery, Cullompton, Devon, where his “integrated practice” includes dozens of alternative practitioners. They include not only disproven things like homeopathy and acupuncture, but also even more bizarre practitioners in ‘Thought Field Therapy‘ and ‘Frequencies of Brilliance‘.

To take only one of these, ‘Frequencies of Brilliance’ is bizarre beyond belief. One need only quote its founder and chief salesperson.

“Frequencies of Brilliance is a unique energy healing technique that involves the activation of energetic doorways on both the front and back of the body.”

“These doorways are opened through a series of light touches. This activation introduces high-level Frequencies into the emotional and physical bodies.  It works within all the cells and with the entire nervous system which activates new areas of the brain.”

“Frequencies of Brilliance is a 4th /5th dimensional work.   The process is that of activating doorways by lightly touching the body or working just above the body.”

“Each doorway holds the highest aspect of the human being and is complete in itself. This means that there is a perfect potential to be accessed and activated throughout the doorways in the body.”

Best of all, it can all be done at a distance (that must help sales a lot). One is reminded of the Skills for Health “competence” in distant healing (inserted on a government web site at the behest (you guessed it) of the Prince’s Foundation, as related here)

“The intent of a long distance Frequencies of Brilliance (FOB) session is to enable a practitioner to facilitate a session in one geographical location while the client is in another.

A practitioner of FOB that has successfully completed a Stage 5 Frequency workshop has the ability to create and hold a stable energetic space in order to work with a person that is not physically present in the same room.

The space that is consciously created in the Frequencies of Brilliance work is known as the “Gap”. It is a space of nonlinear time. It contains ”no time and no space” or  respectively “all time and all space”. Within this “Gap” a clear transfer of the energies takes place and is transmitted to an individual at a time and location consciously intended. Since this dimensional space is in non-linear time the work can be performed and sent backward or forward in time as well as to any location.

The Frequencies of Brilliance work cuts through the limitations of our physical existence and allows us to experience ourselves in other dimensional spaces. Therefore people living in other geographic locations than a practitioner have an opportunity to receive and experience the work.

The awareness of this dimensional space is spoken about in many indigenous traditions, meditation practices, and in the world of quantum physics. It is referred to by other names such as the void, or vacuum space, etc.”

This is, of course, preposterous gobbledygook.  It, and other things in Dr Dixon’s treatment guide, seem to be very curious things to impose on patients in the 21st century.

Latest news.  The Mid-Devon Star announces yet more homeopathy in Dr Dixon’s Cullompton practice.  This time it comes in the form of a clinic run from the Bristol Homeopathic Hospital.  I guess they must be suffering from reduced commissioning like all the other homeopathic hospitals, but Dr Dixon seems to have come to their rescue. The connection seems to be with Bristol’s homeopathic consultant, Dr Elizabeth A Thompson.   On 11 December 2007 I wrote to Dr Thompson, thus

 In March 2006, a press release http://www.ubht.nhs.uk/press/view.asp?257 announced a randomised trial for homeopathic treatment of asthma in children. This was reported also on the BBC http://news.bbc.co.uk/1/hi/england/bristol/4971050.stm . I’d be very grateful if you could let me know when results from this trial will become available. Yours sincerely David Colquhoun

The reply, dated 11 December 2007, was unsympathetic

 I have just submitted the funders report today and we have set ourselves the deadline to publish two inter-related papers by March 1st 2007. Can I ask why you are asking and what authority you have to gain this information. I shall expect a reply to my questions,

I answered this question politely on the same day but nevertheless my innocent enquiry drew forth a rather vitriolic complaint from Dr Thompson to the Provost of UCL (dated 14 December 2007).  In this case, the Provost came up trumps. On 14 January 2008 he replied to Thompson: “I have looked at the email that you copied to me, and I must say that it seems an entirely proper and reasonable request. It is not clear to me why Professor Colquhoun should require some special authority to make such direct enquiries”.  Dr Thompson seems to be very sensitive. We have yet to see the results of her trial in which I’m still interested.

Not surprisingly, Dr Dixon has had some severe criticism for his views, not least from the UK’s foremost expert on the evidence for efficacy,  Prof Edzard Ernst.   Accounts of this can be found in Pulse,
and on Andrew Lewis’s blog.

Dixon is now (in)famous in the USA too.  The excellent Yale neurologist,  Steven Novella, has written an analysis of his views on Science Based Medicine. He  describes Dr. Michael Dixon as  “A Pyromaniac In a Field of (Integrative) Straw Men

### Peter Hain

09:40 Politics and people: can integrated health and care take centre stage in 2009/2010? Rt Hon Peter Hain MP

It seems that Peter Hain was converted to alternative medicine when his first baby, Sam, was born with eczema. After (though possibly not because of) homeopathic treatment and a change in diet, the eczema got better. This caused Hain, while Northern Ireland Secretary to spend £200,000 of taxpayers’ money to set up a totally uninformative customer satisfaction survey, which is being touted elsewhere in this meeting as though it were evidence (see below). I have written about this episode before:  see Peter Hain and Get Well UK: pseudoscience and privatisation in Northern Ireland.

I find it very sad that a hero of my youth (for his work in the anti-apartheid movement) should have sunk to promoting junk science, and even sadder that he does so at my expense.

There has been a report on Hain’s contribution in Wales Online.

09:55 Why does the Health Service need a new perspective on health and healing? Sir Cyril Chantler, Chair, King’s Fund, previous Dean, Guy’s Hospital and Great Ormond Street

Cyril Chantler is a distinguished medical administrator. He also likes to talk and we have discussed the quackery problem several times. He kindly sent me the slides that he used.   Slide 18 says that in order to do some good we “need to demonstrate that the treatment is clinically effective and cost effective for NHS use”.  That’s impeccable, but throughout the rest of the slides he talks of integrating with  complementary” therapies, the effectiveness of which is either already disproved or simply not known.

I remain utterly baffled by the reluctance of some quite sensible people to grasp the nettle of deciding what works. Chantler fails to grasp the nettle, as does the Department of Health. Until they do so, I don’t see how they can be taken seriously.

10.05 Panel discussion

The Awards

10:20 Integrated Health Awards 2009 Introduction: a review of the short-listed applications

10:45 Presentations to the Award winners by the special guest speaker

11:00 Keynote address by special guest speaker

Getting integrated

### Dr David Peters

12:00 Integration, long term disease and creating a sustainable NHS. Professor David Peters, Clinical Director and Professor of Integrated Healthcare, University of Westminster

I first met David Peters after Nature ran my article, Science Degrees without the Science. .One of the many media follow-ups of that article was on Material World (BBC Radio 4). This excellent science programme, presented by Quentin Cooper, had a discussion between me and David Peters ( listen to the mp3 file).

There was helpful intervention from Michael Marmot who had talked, in the first half of the programme, about his longitudinal population studies.

Marmot stressed the need for proper testing.  In the case of
homeopathy and acupuncture, that proper testing has largely been done.  The tests were failed.

The University of Westminster has, of course, gained considerable notoriety as the university that runs more degree programmes in anti-scientific forms of medicine than any other.  Their lecture on vibrational medicine teaches students that amethysts “emit high Yin energy so transmuting lower energies and clearing and aligning energy disturbances at all levels of being”.   So far their vice-chancellor, Professor Geoffrey Petts, has declined to answer enquiries about whether he thinks such gobbledygook is appropriate for a BSc degree.

But he did set up an internal enquiry into the future of their alternative activities. Sadly that enquiry seems to have come to the nonsensical conclusion that the problem can be solved by injection of good science into the courses, as reported here and in the Guardian.
It seems obvious that if you inject good science into their BSc in homeopathy the subject will simply vanish in a puff of smoke.

In 2007, the University of Westminster did respond to earlier criticism in Times Higher Education, but their response seemed to me to serve only to dig themselves deeper into a hole.

Nevertheless, Westminster has now closed down its homeopathy degree (the last in the country to go) and there is intense internal discussion going on there. I have the impression that Dr Peters’ job is in danger.  The revelation of more slides from their courses on homeopathy, naturopathy and Chinese herbal medicine shows that these courses are not only barmy, but also sometimes dangerous.

### Professor Chris Fowler

12:10 Educating tomorrow’s integrated doctors. Professor Chris Fowler, Dean for Education, Barts and The London School of Medicine and Dentistry

I first came across Dr Fowler when I noticed him being praised for his teaching of alternative medicine to students at Barts and the London Medical School on the web site of the Prince’s Foundation. I wrote him a polite letter to ask if he really thought that the Prince of Wales was the right person to consult about the education of medical students.  The response I got was, ahem, unsympathetic. But a little while later I noticed that two different Barts students had set up public blogs that criticised strongly the nonsense that was being inflicted on them.

At that point, I felt it was necessary to support the students who, it seemed to me, knew more about medical education than Professor Fowler. It didn’t take long to uncover the nonsense that was being inflicted on the students: read about it here.

There is a follow-up to this story here.  Fortunately, Barts’ Director of Research, and, I’m told, the Warden of Barts, appear to agree with my view of the harm that this sort of thing can do to the reputation of Barts, so things may change soon,

### Dame Donna Kinnair

12:30 Educating tomorrow’s integrated nurses.
Dame Donna Kinnair, Director of Nursing, Southwark PCT

As far as I can see, Donna Kinnair has no interest in alternative medicine. She is director of nursing at Southwark primary care trust and was an adviser to Lord Laming throughout his inquiry into the death of Victoria Climbié.  I  suspect that her interest is in integrating child care services (they need it, judging by the recent death of ‘Baby P’).  Perhaps her presence shows the danger of using euphemisms like ‘integrated medicine’ when what you really mean is the introduction of unproven or disproved forms of medicine.

### Michael Dooley

12:40 Integrating the care of women: an example of the new paradigm. Michael Dooley, Consultant Obstetrician and Gynecologist

DC’s rule 2. Never trust anyone who uses the word ‘paradigm’.   It is a sure-fire sign of pseudoscience.  In this case, the ‘new paradigm’ seems to be the introduction of disproven treatment.  Dooley is a gynaecologist and Medical Director of the Poundbury Clinic.  His clinic offers a whole range of unproven and disproved treatments.  These include acupuncture  as an aid to conception in IVF. This is not recommended by the Cochrane review, and one report suggests that it hinders conception rather than helps.

12.40   Discussion

13.00 – 14.00  Lunch and Exhibition

15.30    Tea

### Boo Armstrong and Get Well UK

16.00   Integrated services in action: The Northern
Ireland experience: what has it shown us and what are its implications?
Boo Armstrong of Get Well UK with a team from the NI study

I expect that much will be made of this “study”, which, of course, tells you absolutely nothing whatsoever about the effectiveness of the alternative treatments that were used in it. This does not appear to be the view of Boo Armstrong,   On the basis of the “study”, her company’s web site proclaims boldly

“Complementary Medicine Works

Get Well UK ran the first government-backed complementary therapy project in the UK, from February 2007 to February 2008″

This claim appears, prima facie, to breach the Unfair Trading Regulations of May 2008.   The legality of the claim is, at the moment, being judged by a Trading Standards Officer.  In any case, the “study” was not backed by the government as a whole, but just by Peter Hain’s office.  It is not even clear that it had ethical approval.

The study consisted merely of asking people who had seen an alternative medicine practitioner whether they felt better or worse.  There was no control group; no sort of comparison was made.  It is surely obvious to the most naive person that a study like this cannot even tell you if the treatment has a placebo effect, never mind that it has any genuine effects of its own.  To claim that it does so seems to be simply dishonest.  There is no reason at all to think that the patients would not have got better anyway.

It is not only Get Well UK who misrepresent the evidence.  The Prince’s
Foundation itself
says

“Now a new, year long trial supported by the Northern Ireland health service has . . . demonstrated that integrating complementary and conventional medicine brings measurable benefits to patients’ health.”

That is simply not true. It is either dishonest or stupid. Don’t ask me which, I have no idea.

This study is no more informative than the infamous Spence (2005) ‘study’ of the same type, which seems to be the only thing that homeopaths can produce to support their case.

There is an excellent analysis of the Northern Ireland ‘study’ by Andy Lewis, The Northern Ireland NHS Alternative Medicine ‘Trial’.  He explains patiently, yet again, what constitutes evidence and why studies like this are useless.

His analogy starts

” . . . the Apple Marketing Board approach the NHS and ask for £200,000 to do a study to show the truth behind the statement ‘An apple a day keeps the doctor away’. The Minister, being particularly fond of apples, agrees and the study begins.”

16.30 Social enterprise and whole systems integrated care.  Dee Kyne, Sandwell PCT and a GP.  Developing an integrated service in secondary care

Dee Kyne appears to be CEO of KeepmWell Ltd (a financial interest that is not mentioned).

Peter Mackereth, Clinical Lead, Supportive Services, Christie Hospital NHS Foundation Trust

I had some correspondence with Mackereth when the Times (7 Feb 2007) published a picture of the Prince of Wales inspecting an “anti-MRSA aromatherapy inhaler” in his department at the Christie. It turned out that the trial they were doing was not blind   No result has been announced anyway, and on enquiry, I find that the trial has not even started yet.  Surprising, then to find that the FIH is running the First Clinical Aromatherapy Conference at the Christie Hospital,  What will there be to talk about?

Much of what they do at the Christie is straightforward massage, but they also promote the nonsensical principles of “reflexology” and acupuncture.

The former is untested.  The latter is disproven.

Parallel Sessions

Developing a PCT funded musculoskeletal service Dr Roy Welford, Glastonbury Health Centre

Roy Welford is a Fellow of the Faculty of Homeopathy, and so promotes disproven therapies. The Glastonbury practice also advertises acupuncture (disproven), osteopathy and herbal medicine (largely untested so most of it consists of giving patients an unknown dose of an ill-defined drug, of unknown effectiveness and unknown safety).

Making the best of herbal self-prescription in integrated practice: key remedies and principles. Simon Mills, Project Lead: Integrated Self Care in Family Practice, Culm Valley Integrated Centre for Health, Devon

Simon Mills is a herbalist who now describes himself as a “phytotherapist” (it sounds posher, but the evidence, or lack of it, is not changed by the fancy name). Mills likes to say things like “there are herbs for heating and drying”, “hot and cold” remedies, and to use meaningless terms like “blood cleanser”, but he appears to be immune to the need for good evidence that herbs work before you give them to sick people. He says, at the end of a talk, “The hot and the cold remain the trade secret of traditional medicine”.  And this is the 21st Century.

Practical ways in which complementary approaches can improve the treatment of cancer. Professor Jane Plant, Author of “Your life in your hands” and Chief Scientist, British Geological Society and Professor Karol Sikora, Medical Director, Cancer Partners UK

Jane Plant is a geologist who, through her own unfortunate encounter with breast cancer, became obsessed with the idea that a dairy-free diet cured her.  Sadly there is no good evidence for that idea, according to the World Cancer Research Fund Report, led by Professor Sir Michael Marmot.   No doubt her book on the subject sells well, but it could be held that it is irresponsible to hold out false hopes to desperate people.   She is a supporter of the very dubious CancerActive organisation (also supported by Michael Dixon OBE –see above) as well as the notorious pill salesman, Patrick Holford (see also here).

Karol Sikora, formerly an oncologist at the Hammersmith Hospital, is now Dean of Medicine at the University of Buckingham (the UK’s only private university).  He is also medical director at CancerPartners UK, a private cancer company.

He recently shot to fame when he appeared in a commercial in the USA sponsored by “Conservatives for Patients’ Rights”, to pour scorn on the NHS, and to act as an advocate for the USA’s present health system. A very curious performance.  Very curious indeed.

His attitude to quackery is a mystery wrapped in an enigma.  One was somewhat alarmed to see him sponsoring a course at what was, at first, called the British College of Integrated Medicine, and has now been renamed the Faculty of Integrated Medicine That grand title makes it sound like part of a university.  It isn’t.

The alarm was as result of the alliance with Dr Rosy Daniel (who promotes an untested herbal conconction, Carctol, for ‘healing’ cancer) and Dr Mark Atkinson (a supplement salesman who has also promoted the Qlink pendant.  The Qlink pendant is a simple and obvious fraud designed to exploit paranoia about WiFi killing you.

The first list of speakers on the proposed diploma in Integrated Medicine was an unholy alliance of outright quacks and commercial interests.  It turned out that, although Karol Sikora is sponsoring the course, he knew nothing about the speakers.  I did and when I pointed this out to Terence Kealey, vice-chancellor of Buckingham, he immediately removed Rosy Daniel from directing the Diploma.  At the moment the course is being revamped entirely by Andrew Miles.  There is hope that he’ll do a better job.  It has not yet been validated by the University of Buckingham. Watch this space for developments.

Stop press It is reported in the Guardian that Professor Sikora has been describing his previous job at Imperial College with less than perfect accuracy. Oh dear. More developments in the follow-up.

The role of happy chickens in healing: farms as producers of health as well as food – the Care Farm Initiative Jonathan Dover, Project Manager, Care Farming, West Midlands.

“Care farming is a partnership between farmers, participants and health & social care providers. It combines the care of the land with the care of people, reconnecting people with nature and their communities.”

Sounds lovely, I wonder how well it works?

What can the Brits learn from the Yanks when it comes to integrated health? Jack Lord, Chief Executive Humana Europe

It is worth noticing that the advisory board of Humana Europe includes Micheal Dixon OBE, a well known advocate of alternative medicine (see
above
).  Humana Europe is a private company, a wholly owned subsidiary of Humana Inc., a health benefits company with 11 million members and 22,000 employees and headquarters in Louisville, Kentucky.  In 2005 it entered into a business partnership with Virgin Group. Humana was mentioned in the BBC Panorama programme “NHS for Sale”. The company later asked that it be pointed out that they provide commissioning services, not clinical services [Ed. well not yet anyway].

Humana’s document “Humana uses computer games to help people lead healthier lives” is decidedly bizarre.  Hang on, it was only a moment ago that we were being told that computer games rewired your brain.

### Day 2 Integrated health in action

09.00 Health, epidemics and the search for new solutions. Sir Michael Marmot, Professor of Epidemiology and Public Health, Royal Free and University College Medical School

It is a mystery to me that a distinguished epidemiologist should be willing to keep such dubious company. Sadly I don’t know what he said, but judging my his publications and his appearence on Natural World, I can’t imagine he’d have much time for homeopaths.

9.25 Improving health in the workplace. Dame Carol Black, National Director, Health and Work, Department of Health

This is not the first time that Dame Carol has been comtroversial.

9.45 Integrated health in focus: defeating obesity. Professor Chris Drinkwater, President, NHS Alliance.

The NHS Alliance was mentioned above.   Enough said.

10.00 Integrated healthcare in focus: new approaches to managing asthma, eczema and allergy. Professor Stephen Holgate, Professor of Immunopharmacology, University of Southampton

10.15 Using the natural environment to increase activity. The Natural England Project: the results from year one. Dr William Bird and Ruth Tucker, Natural England.

10.30 Panel discussion

10.45 Coffee

Self help in action

11.10    Your health, your way: supporting self care through care planning and the use of personal budgets. Angela Hawley, Self Care Lead, Department of Health

11.25    NHS Life Check: providing the signposts to
integrated health. Roy Lambley, Project Director, NHS LifeCheck Programme

This programme was developed with the University of Westminster’s “Health and Well-being Network”. This group, with one exception, is separate from Westminster’s extensive alternative medicine branch (it’s mostly psychologists).

11.45    The agony and the ecstasy of helping patients to help themselves: tips for clinicians, practices and PCTs. Professor
Ruth Chambers, FIH Foundation Fellow.

11.55    Providing self help in practice: Department of Health Integrated Self Help Information Project. Simon Mills, Project Lead: Integrated Self Care in Family Practice, Culm Valley Integrated Centre for Health, Devon and Dr Sam Everington, GP, Bromley by Bow.

The Culm  Valley Integrated Centre for health is part of the College Surgery Partnership, associated with Michael Dixon OBE (yes, again!).

Simon Mills is the herbalist who says “The hot and the cold remain the trade secret of traditional medicine” .

Sam Everington, in contrast, seems to be interested in ‘integration’ in the real sense of the word, rather than quackery.

Integrated health in action

How to make sense of the evidence on complementary approaches: what works? What might work? What doesn’t work?
Dr Hugh MacPherson, Senior Research Fellow in Health Sciences, York University and Dr Catherine Zollman, Bravewell Fellow

Hugh MacPherson‘s main interest is in acupuncture and he publishes in alternative medicine journals. Since the recent analysis in the BMJ from the Nordic Cochrane Centre (Madsen et al.,  2009) it seems that  acupuncture is finally dead. Even its placebo effect is too small to be useful. Catherine Zollman is a Bristol GP who is into homeopathy as well as acupuncture.  She is closely connected with the Prince’s Foundation via the Bravewell Fellowship. That fellowship is funded by the Bravewell Collaboration, which is run by Christie Mack, wife of John Mack (‘Mack the Knife’), head of Morgan Stanley (amazingly, they still seem to have money). This is the group which, by sheer wealth, has persuaded so many otherwise respectable US universities to embrace every sort of quackery (see, for example, Integrative baloney @ Yale)

The funding of integrated services

14.15 How to get a PCT or practice- based commissioner to fund your integrated service. A PCT Chief Executive and a Practice-Based Commissioning lead.

14.30 How I succeeded: funding an integrated service. Dr John Ribchester, Whitstable

14.45 How we created an acupuncture service in St Albans and Harpenden PBC group. Mo Girach, Chief Executive, STAHCOM

Uhuh Acupunture again. Have these people never read Bausell’s
book
?  Have they not read the BMJ?  Acupuncture is now ell-established to be based on fraudulent principles, and not even to have a worthwhile placeobo effect.  STAHCOM seem to be more interested in money than in what works.

Dragon’s Den. Four pitchers lay out their stall for the commissioning dragons

And at this stage there is no prize for guessing that all four are devoted to trying to get funds for discredited treatments

• An acupuncture service for long-term pain. Mike Cummings Chair, Medical Acupuncture Association
• Manipulation for the treatment of back pain Simon Fielding, Founder Chairman of the General Osteopathic Council
• Nigel Clarke, Senior Partner, Learned Lion Partners Homeopathy for long term conditions
• Peter Fisher, Director, Royal Homeopathic Hospital

Sadly it is not stated who the dragons are. One hopes they will be more interested in evidence than the supplicants.

Mike Cummings at least doesn’t believe the nonsense about meridians and Qi. It’s a pity he doesn’t look at the real evidence though.
You can read something about him and his journal at BMJ Group promotes acupuncture: pure greed.

Osteopathy sounds a bit more respectable than the others, but in fact it has never shaken off its cult-like origins. Still many osteopaths make absurd claims to cure all sorts of diseases. Offshoots of osteopathy like ‘cranial osteopathy’ are obvious nonsense. There is no reason to think that osteopathy is any better than any other manipulative therapy and it is clear that all manipulative therapies should be grouped into one.

Osteopathy and chiropractic provide the best ever examples of the folly of giving official government recognition to a branch of alternative medicine before the evidence is in.

Learned Lion Partners is a new one on me. It seems it is
part of Madsen Gornall Ashe Chambers (‘MGA Chambers’) “a grouping of top level, independent specialists who provide a broad range of management consultancy advice to the marketing community”.  It’s a management consultant and marketing outfit.    So don’t expect too much when it comes to truth and evidence. The company web site says nothing about alternative medicine, but only that Nigel Clarke

“. . . has very wide experience of public affairs issues and campaigns, having worked with clients in many sectors in Europe, North America and the Far East. He has particular expertise in financial, competition and healthcare issues. “

However, all is revealed when we see that he is a Trustee of the Prince’s Foundation where his entry says

“Nigel Clarke is senior partner of Learned Lion Partners. He is a director of Vidapulse Ltd, Really Easy Ltd, Newscounter Ltd and Advanced Transport Systems Ltd. He has worked on the interfaces of public policy for 25 years. He has been chair of the General Osteopathic Council since May 2001, having been a lay member since it was formed. He is now a member of the Council for Healthcare Regulatory Excellence”

The Council for Healthcare Regulatory Excellence is yet another quango that ticks boxes and fails absolutely to grasp the one important point, does it work?.  I came across them at the Westminster Forum, and they seemed a pretty pathetic way to spend £2m per year.

Peter Fisher is the last supplicant to the Dragons.  He is clinical director of the Royal London Homeopathic Hospital (RLHH), and Queen’s homeopathic physician,  It was through him that I got an active interest in quackery. The TV programme QED asked me to check the statistics in a paper of his that claimed that homeopathy was good for fibrositis (there was an elementary mistake and no evidence for an effect).  Peter Fisher is also remarkable because he agreed with me that BSc degrees in homeopathy were not justified (on TV –see the movie).   And he condemned homeopaths who were caught out recommending their sugar pills for malaria.  To that extent Fisher represents the saner end of the homeopathic spectrum.  Nevertheless he still maintains that sugar pills work and have effects of their own, and tries to justify the ‘memory of water’ by making analogies with a memory stick or CD.  This is so obviously silly that no more comment is needed.

Given Fisher’s sensible condemnation of the malaria fiasco, I was rather surprised to see that he appeared on the programme of a conference at the University of Middlesex, talking about “A Strategy To Research The Potential Of Homeopathy In Pandemic Flu”.   The title of the conference was Developing Research Strategies in CAM.   A colleague, after seeing the programme, thought it was more like “a right tossers’ ball”.

Much of the homeopathy has now vanished from the RLHH as a result of greatly reduced commissioning by PCTs (read about it in Fisher’s own words). And the last homeopathy degree in the UK has closed down. It seems an odd moment for the FIH to be pushing it so hard.

### Follow-up

Stop press It is reported in the Guardian (22 May 2009) that Professor Sikora has been describing his previous job at Imperial College with less than perfect accuracy. Oh dear, oh dear.

This fascinating fact seems to have been unearthed first by the admirable NHS Blog Doctor, in his post ‘Imperial College confirm that Karol Sikora does not work for them and does not speak on their behalf‘.

I’m perfectly happy to think of alternative medicine as being a voluntary, self-imposed tax on the gullible (to paraphrase Goldacre again). But only as long as its practitioners do no harm and only as long as they obey the law of the land.  Only too often, though, they do neither.

When I talk about law, I don’t mean lawsuits for defamation.  Defamation suits are what homeopaths and chiropractors like to use to silence critics. heaven knows, I’ve becomes accustomed to being defamed by people who are, in my view. fraudsters, but lawsuits are not the way to deal with it.

I’m talking about the Trading Standards laws   Everyone has to obey them, and in May 2008 the law changed in a way that puts the whole health fraud industry in jeopardy.

The gist of the matter is that it is now illegal to claim that a product will benefit your health if you can’t produce evidence to justify the claim.

I’m not a lawyer, but with the help of two lawyers and a trading standards officer I’ve attempted a summary.  The machinery for enforcing the law does not yet work well, but when it does, there should be some very interesting cases.

The obvious targets are homeopaths who claim to cure malaria and AIDS, and traditional Chinese Medicine people who claim to cure cancer.

But there are some less obvious targets for prosecution too.   Here is a selection of possibilities to savour..

• Universities such as Westminster, Central Lancashire and the rest, which promote the spreading of false health claims
• Hospitals, like the Royal London Homeopathic Hospital, that treat patients with mistletoe and marigold paste. Can they produce any real evidence that they work?
• Edexcel, which sets examinations in alternative medicine (and charges for them)
• Ofsted and the QCA which validate these exams
• Skills for Health and a whole maze of other unelected and unaccountable quangos which offer “national occupational standards” in everything from distant healing to hot stone therapy, thereby giving official sanction to all manner of treatments for which no plausible evidence can be offered.
• The Prince of Wales Foundation for Integrated Health, which notoriously offers health advice for which it cannot produce good evidence
• Perhaps even the Department of Health itself, which notoriously referred to “psychic surgery” as a profession, and which has consistently refused to refer dubious therapies to NICE for assessment.

The law, insofar as I’ve understood it, is probably such that only the first three or four of these have sufficient commercial elements for there to be any chance of a successful prosecution.  That is something that will eventually have to be argued in court.

But lecanardnoir points out in his comment below that The Prince of Wales is intending to sell herbal concoctions, so perhaps he could end up in court too.

### The laws

We are talking about The Consumer Protection from Unfair Trading Regulations 2008.  The regulations came into force on 26 May 2008.   The full regulations can be seen here,  or download pdf file. They can be seen also on the UK Statute Law Database.

The Office of Fair Trading, and Department for Business, Enterprise & Regulatory Reform (BERR) published Guidance on the Consumer Protection from Unfair Trading Regulations 2008 (pdf file),
Statement of consumer protection enforcement principles (pdf file), and
The Consumer Protection from Unfair Trading Regulations: a basic guide for business (pdf file).

Has The UK Quietly Outlawed “Alternative” Medicine?

On 26 September 2008, Mondaq Business Briefing published this article by a Glasgow lawyer, Douglas McLachlan.   (Oddly enough, this article was reproduced on the National Center for Homeopathy web site.)

“Proponents of the myriad of forms of alternative medicine argue that it is in some way “outside science” or that “science doesn’t understand why it works”. Critical thinking scientists disagree. The best available scientific data shows that alternative medicine simply doesn’t work, they say: studies repeatedly show that the effect of some of these alternative medical therapies is indistinguishable from the well documented, but very strange “placebo effect” ”

“Enter The Consumer Protection from Unfair Trading Regulations 2008(the “Regulations”). The Regulations came into force on 26 May 2008 to surprisingly little fanfare, despite the fact they represent the most extensive modernisation and simplification of the consumer protection framework for 20 years.”

The Regulations prohibit unfair commercial practices between traders and consumers through five prohibitions:-

• General Prohibition on Unfair Commercial
Practices (Regulation 3)
• Prohibition on Misleading Actions (Regulations 5)
• Prohibition on Misleading Omissions (Regulation 6)
• Prohibition on Aggressive Commercial Practices (Regulation 7)
• Prohibition on 31 Specific Commercial Practices that are in all Circumstances Unfair (Schedule 1).  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 definition of “product” in the Regulations includes services, so it does appear that all forms medical products and treatments will be covered.

Just look at that!

 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”

Section 5 is equally powerful, and also does not contain the contentious word “cure” (see note below)

5.—(1) A commercial practice is a misleading action if it satisfies the conditions in either paragraph (2) or paragraph (3).

(2) A commercial practice satisfies the conditions of this paragraph—

(a) if it contains false information and is therefore untruthful in relation to any of the matters in paragraph (4) or if it or its overall presentation in any way deceives or is likely to deceive the average consumer in relation to any of the matters in that paragraph, even if the information is factually correct; and

(b) it causes or is likely to cause the average consumer to take a transactional decision he would not have taken otherwise.

These laws are very powerful in principle, But there are two complications in practice.

One complication concerns the extent to which the onus has been moved on to the seller to prove the claims are true, rather than the accuser having to prove they are false. That is a lot more favourable to the accuser than before, but it’s complicated.

The other complication concerns enforcement of the new laws, and at the moment that is bad.

### Who has to prove what?

That is still not entirely clear.  McLachlan says

“If we accept that mainstream evidence based medicine is in some way accepted by mainstream science, and alternative medicine bears the “alternative” qualifier simply because it is not supported by mainstream science, then where does that leave a trader who seeks to refute any allegation that his claim is false?

Of course it is always open to the trader to show that his the alternative therapy actually works, but the weight of scientific evidence is likely to be against him.”

On the other hand, I’m advised by a Trading Standards Officer that “He doesn’t have to refute anything! The prosecution have to prove the claims are false”.  This has been confirmed by another Trading Standards Officer who said

“It is not clear (though it seems to be) what difference is implied between “cure” and “treat”, or what evidence is required to demonstrate that such a cure is false “beyond reasonable doubt” in court. The regulations do not provide that the maker of claims must show that the claims are true, or set a standard indicating how such a proof may be shown.”

The main defence against prosecution seems to be the “Due diligence defence”, in paragraph 17.

Due diligence defence

17. —(1) In any proceedings against a person for an offence under regulation 9, 10, 11 or 12 it is a defence for that person to prove—

(a) that the commission of the offence was due to—

(i) a mistake;

(ii) reliance on information supplied to him by another person;

(iii) the act or default of another person;

(iv) an accident; or

(v) another cause beyond his control; and

(b) that he took all reasonable precautions and exercised all due diligence to avoid the commission of such an offence by himself or any person under his control.

If “taking all reasonable precautions” includes being aware of the lack of any good evidence that what you are selling is effective, then this defence should not be much use for most quacks.

Douglas McLachlan has clarified, below, this difficult question

### False claims for health benefits of foods

A separate bit of legislation, European regulation on nutrition and health claims made on food, ref 1924/2006, in Article 6, seems clearer in specifying that the seller has to prove any claims they make.

Article 6

Scientific substantiation for claims

1. Nutrition and health claims shall be based on and substantiated by generally accepted scientific evidence.

2. A food business operator making a nutrition or health claim shall justify the use of the claim.

3. The competent authorities of the Member States may request a food business operator or a person placing a product on the market to produce all relevant elements and data establishing compliance with this Regulation.

That clearly places the onus on the seller to provide evidence for claims that are made, rather than the complainant having to ‘prove’ that the claims are false.

On the problem of “health foods” the two bits of legislation seem to overlap.  Both have been discussed in “Trading regulations and health foods“, an editorial in the BMJ by M. E. J. Lean (Professor of Human Nutrition in Glasgow).

“It is already illegal under food labelling regulations (1996) to claim that food products can treat or prevent disease. However, huge numbers of such claims are still made, particularly for obesity ”

“The new regulations provide good legislation to protect vulnerable consumers from misleading “health food” claims. They now need to be enforced proactively to help direct doctors and consumers towards safe, cost effective, and evidence based management of diseases.”

In fact the European Food Standards Agency (EFSA) seems to be doing a rather good job at imposing the rules. This, predictably, provoked howls of anguish from the food industry There is a synopsis here.

“Of eight assessed claims, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected seven for failing to demonstrate causality between consumption of specific nutrients or foods and intended health benefits. EFSA has subsequently issued opinions on about 30 claims with seven drawing positive opinions.”

“. . .  EFSA in disgust threw out 120 dossiers supposedly in support of nutrients seeking addition to the FSD’s positive list.

If EFSA was bewildered by the lack of data in the dossiers, it needn’t hav been as industry freely admitted it had in many cases submitted such hollow documents to temporarily keep nutrients on-market.”

Or, on another industry site, “EFSA’s harsh health claim regime

“By setting an unworkably high standard for claims substantiation, EFSA is threatening R&D not to mention health claims that have long been officially approved in many jurisdictions.”

Here, of course,”unworkably high standard” just means real genuine evidence. How dare they ask for that!

### Enforcement of the law

19. —(1) It shall be the duty of every enforcement authority to enforce these Regulations.
(2) Where the enforcement authority is a local weights and measures authority the duty referred to in paragraph (1) shall apply to the enforcement of these Regulations within the authority’s area.

Nevertheless, enforcement is undoubtedly a weak point at the moment. The UK is obliged to enforce these laws, but at the moment it is not doing so effectively.

A letter in the BMJ from Rose & Garrow describes two complaints under the legislation in which it appears that a Trading Standards office failed to enforce the law. They comment

” . . . member states are obliged not only to enact it as national legislation but to enforce it. The evidence that the government has provided adequate resources for enforcement, in the form of staff and their proper training, is not convincing. The media, and especially the internet, are replete with false claims about health care, and sick people need protection. All EU citizens have the right to complain to the EU Commission if their government fails to provide that protection.”

This is not a good start.   A lawyer has pointed out to me

“that it can sometimes be very difficult to get Trading Standards or the OFT to take an interest in something that they don’t fully understand. I think that if it doesn’t immediately leap out at them as being false (e.g “these pills cure all forms of cancer”)  then it’s going to be extremely difficult. To be fair, neither Trading Standards nor the OFT were ever intended to be medical regulators and they have limited resources available to them. The new Regulations are a useful new weapon in the fight against quackery, but they are no substitute for proper regulation.”

Trading Standards originated in Weights and Measures.   It was their job to check that your pint of beer was really a pint. Now they are being expected to judge medical controversies. Either they will need more people and more training,  or responsibility for enforcement of the law should be transferred to some more appropriate agency (though one hesitates to suggest the MHRA after their recent pathetic performance in this area).

### Who can be prosecuted?

Any “trader”, a person or a company. There is no need to have actually bought anything, and no need to have suffered actual harm. In fact there is no need for there to be a complainant at all. Trading standards officers can act on their own. But there must be a commercial element. It’s unlikely that simply preaching nonsense would be sufficient to get you prosecuted, so the Prince of Wales is, sadly, probably safe.

Universities who teach that “Amethysts emit high Yin energy” make an interesting case. They charge fees and in return they are “falsely claiming that a product is able to cure illnesses”.
In my view they are behaving illegally, but we shan’t know until a university is taken to court.  Watch this space.

The fact remains that the UK is obliged to enforce the law and presumably it will do so eventually. When it does, alternative medicine will have to change very radically. If it were prevented from making false claims, there would be very little of it left apart from tea and sympathy

### Follow-up

New Zealand must have similar laws.
Just as I was about to post this I found that in New Zealand a

“couple who sold homeopathic remedies claiming to cure bird flu, herpes and Sars (severe acute respiratory syndrome) have been convicted of breaching the Fair Trading Act.”

### Is the solution government regulation?

In New Zealand the law about misleading the public into believing you are a medical practitioner already exists. The immediate problem would be solved if that law were taken seriously, but it seems that it is not.

It is common in both the UK and in New Zealand to suggest that some sort of official government regulation is the answer. That solution is proposed in this issue of NZMJ by Evans et al2. A similar thing has been proposed recently in the UK by a committee headed by Michael Pittilo, vice-chancellor of Robert Gordon’s University, Aberdeen.

I have written about the latter under the heading A very bad report. The Pittilo report recommends both government regulation and more degrees in alternative medicine. Given that we now know that most alternative medicine doesn’t work, the idea of giving degrees in such subjects must be quite ludicrous to any thinking person.

The magazine Nature7 recently investigated the 16 UK universities who run such degrees. In the UK, first-year students at the University of Westminster are taught that “amethysts emit high yin energy” . Their vice chancellor, Professor Geoffrey Petts, describes himself a s a geomorphologist, but he cannot be tempted to express an opinion about the curative power of amethysts.

There has been a tendency to a form of grade inflation in universities—higher degrees for less work gets bums on seats. For most of us, getting a doctorate involves at least 3 years of hard experimental research in a university. But in the USA and Canada you can get a ‘doctor of chiropractic’ degree and most chiropractic (mis)education is not even in a university but in separate colleges.

Florida State University famously turned down a large donation to start a chiropractic school because they saw, quite rightly, that to do so would damage their intellectual reputation. This map, now widely distributed on the Internet, was produced by one of their chemistry professors, and it did the trick.

Other universities have been less principled. The New Zealand College of Chiropractic [whose President styles himself “Dr Brian Kelly”,though his only qualification is B. App Sci (chiro)] is accredited by the New Zealand Qualifications Authority (NZQA). Presumably they, like their UK equivalent (the QAA), are not allowed to take into account whether what is being taught is nonsense or not. Nonsense courses are accredited by experts in nonsense. That is why much accreditation is not worth the paper it’s written on.

Of course the public needs some protection from dangerous or fraudulent practices, but that can be done better (and more cheaply) by simply enforcing existing legislation on unfair trade practices, and on false advertising. Recent changes in the law on unfair trading in the UK have made it easier to take legal action against people who make health claims that cannot be justified by evidence, and that seems the best
way to regulate medical charlatans.

### Conclusion

For most forms of alternative medicine—including chiropractic and acupuncture—the evidence is now in. There is now better reason than ever before to believe that they are mostly elaborate placebos and, at best, no better than conventional treatments. It is about time that universities and governments recognised the evidence and stopped talking about regulation and accreditation.

Indeed, “falsely claiming that a product is able to cure illnesses, dysfunction, or malformations” is illegal in Europe10.

Making unjustified health claims is a particularly cruel form of unfair trading practice. It calls for prosecutions, not accreditation.

Competing interests: None.
NZMJ 25 July 2008, Vol 121 No 1278; ISSN 1175 8716

Author information: David Colquhoun, Research Fellow, Dept of Pharmacology, University College London, United Kingdom (http://www.ucl.ac.uk/Pharmacology/dc.html)

Correspondence: Professor D Colquhoun, Dept of Pharmacology, University College London, Gower Street, London WC1E 6BT, United Kingdom. Fax: +44(0)20 76797298; email: d.colquhoun@ucl.ac.uk

References:

1. Gilbey A. Use of inappropriate titles by New Zealand practitioners of acupuncture, chiropractic, and osteopathy. N Z Med J. 2008;121(1278). [pdf]

2. Evans A, Duncan B, McHugh P, et al. Inpatients’ use, understanding, and attitudes towards traditional, complementary and alternative therapies at a provincial New Zealand hospital. N Z Med J. 2008;121(1278).

3 Shapiro. Rose. Suckers. How Alternative Medicine Makes Fools of Us All Random House, London 2008. (reviewed here)

4. Singh S, Ernst E. Trick or Treatment. Bantam Press; 2008 (reviewed here)

5. Bausell RB. Snake Oil Science. The Truth about Complementary and Alternative Medicine. (reviewed here)
Oxford University Press; 2007

6. Colquhoun D. Science degrees without the Science, Nature 2007;446:373–4. See also here.

7. Long PH. Stroke and spinal manipulation. J Quality Health Care. 2004;3:8–10.

8. Libin K. Chiropractors called to court. Canadian National Post; June21, 2008.

9. Goldacre B. A menace to science. London: Guardian; February 12, 2007/

10. Department for Business Enterprise & Regulatory Reform (BERR). Consumer Protection from Unfair Trading Regulations 2008. UK: Office of Fair Trading.