Regulating Snake Oil

It is a rare privilege to be able to do something like this, but today the Ministry of Truth has the distinct pleasure of bringing you one of the leading candidates for this year’s most unintentionally hilarious document – the new Complementary & Natural Health Council’s Code of Conduct, Performance and Ethics (pdf, 129kb).

Even before it opened its doors to the world on Monday, the CNHC already possessed all the hallmarks of a classic Whitehall farce. A few years ago, the Prince’s Foundation for Integrated Health (PFIH) screwed £900,000 out of the Department of Health and a further £1 million from the Kings Fund to set up a ‘regulatory framework’ for practitioners of complementary and alternative medicines.

How?

Well, the clue’s in the name, the Prince’s Foundation for Integrated Health. Yes, this is all the ‘brainchild’ of HRH The Prince of Wales, or as he’s known to fans of evidence-based medicine, the Quacktitioner Royal. The very idea of regulating a bunch of self-style ‘professions’, pitifully few of which can produce any substantive evidence to show that their patent remedies perform any better than a placebo might seem to be almost beyond satire, but this hasn’t stopped the Daily Mash from giving it a go and coming up with a cracker of a take on the whole farrago:

STRICT standards must be applied to alternative medicine, according to the voodoo priest who will run the UK’s complimentary therapy watchdog.

Haitian born Papa Limba said his first task as chairman of the Complementary and Natural Healthcare Council would be to identify which therapists were righteous shamans and which had the bad juju.

But the witch doctor stressed the therapists would be judged not on the effectiveness of their treatments but on the strength of their mogambo.

In some respects, that pretty much all you need to know about the background to the CNHC. £1.9 million, a little less than half of which came from the taxpayer, handed over a lobby group to enable it to set up a new organisation to regulate the sale of snake oil.

Bizarre?

Maybe, but then there’s always the fine example of the Press Complaints Commission to draw on a precendent for this kind of thing, so maybe its not quite as odd as it seems after all.

But it gets better because thus far, of all the many varieties of woo the CNHC could be ‘regulating’, only two have signed up thus far; massage therapy and nutritional therapy, although we’re assured that, later in the year, the CHNC will be opening its doors to practitioners of Alexander technique, Aromatherapy, Bowen technique, Cranial therapy, Homeopathy, Naturopathy, Reflexology, Reiki, Shiatsu and Yoga therapy.

Be still my beating heart.

Getting on for around half of everything that the CNHC will be ‘regulating’ by the end of the year involves some kind of massage, and this means that we can usefully illustrate the absurdity of the premise on which this entire organisation is based simply by lifting a few relevant quotations from a Wikipedia section on the benefical effects of massage:

Peer-reviewed medical research has shown that the benefits of massage include pain relief, reduced trait anxiety and depression, and temporarily reduced blood pressure, heart rate, and state anxiety.

The associated citation is a meta-analytical study of massage therapy by Moyer et al (2004) which found statistically significant evidence for the three beneficial effects of a single massage, reduced state anxiety and temporarily reduced blood pressure and heart rate.

Congratulations, we now have peer reviewed evidence which tells us that a massage is relaxing.

As for a course of massage, the study found evidence for pain relief which may be consistent with the theory that massage may provide some pain relief by promoting restorative sleep, while the evidence for reductions in trait anxiety and depression are benchmarked against the effects of psychotherapy, which is not the recommendation it might seem.

But, there’s an important of qualifying information coming up next…

Massage is hindered from reaching the gold standard of scientific research which includes placebo-controlled and double blind clinical trials. Developing a “sham” manual therapy for massage would be difficult since even light touch massage could not be assumed to be completely devoid of effects on the subject. It would also be difficult to find a subject that would not notice that they were getting less of a massage and it would be impossible to blind the therapist.

So we can’t test massage against a placebo but, looking at the beneficial effects it seems we could, hypothetically, carry out a pretty reasonable trial by comparing the efficacy of massage against, say, a nice hot bath, a good chat and a decent night’s sleep, the cost which will be considerably less than that of massage therapy provided you aren’t having to rely on premium rate phone lines for the chat.

Looking on the bright side, there is at least some useful evidence for the efficacy of massage within definable limits; a massage in relaxing and relaxation is a good thing, but where it all goes pear-shaped is when all the new age crap about meridians and chakras is layered on top and the unverifiable claims start flying. The Shiastu Society claims on its website that some of the common conditions that can be helped by Shiatsu include, amongst other things, menstrual problems, digestive problems and asthmatic symptoms, claims that the site, naturally, fails to support by including, on the same page, any citations or links to evidence supporting these claims.

There is, however a research page on the site which directs readers to two interesting studies, a 2008 Cross-European study for which this information is provided by the site.

The development of the study design took particular account of the fact that Shiatsu practice occurs between the practitioner and the client, that it is intuitive in nature, and that it is broad in its guiding philosophy and scope of application. The findings summarised below speak volumes about this ancient art. They validate an intuitive but practical system with contemporary and rational tools, bridging longstanding cultural gaps. These findings are now offered in service to the public, the profession, researchers, policy makers and health care providers.

Economic Implications; A reduction in physician/hospital visits over time alongside a reduction in use of conventional medication was evident.

Symptom Changes; A statistically significant reduction in symptom severity was found for all of the symptom groups.

I could easily spend several enjoyable hours picking the study apart, for starters its a self-reporting study, a methodology which is inherently open to bias, but for now I’ll pick out just one example which raises particular concerns, the set-up for which lies in this description of the ‘theoretical framework’ underpinning the study:

Understanding the underlying philosophical framework of health and healing within the Zen or Masunaga model of shiatsu practice, as an energy-based CAM modality, provides an important backcloth to interpret the study findings and to help cast light on the range of effects that shiatsu could be expected to have. In particular, this was the case for the data relating to clients’ comments on their hopes from shiatsu treatment and any negative responses experienced.

All of which leads to this commentary on the negative responses reported by clients.

Safety and Negative Responses

The prevalence of client-perceived negative responses varied from 12% to 22%, with rates being very similar across all three countries. Rates were highest at ‘4-6 days’ after the initial treatment (18-21%) and lowest at six months (12-17%) follow-up.

Over four-fifths (82%) of the client-expressed ‘negative’ responses were classified as ‘transitional’ effects, that is, an initially negative-seeming response which turned to become positive, either as expressed directly by the client or as part of the healing process predicted within shiatsu theory. A very small proportion (3%, relating to ten client episodes) of the negative responses could be classified as ‘an undesired, potentially adverse event or effect that may represent a risk to client safety’.

Got that?

Depending on the country from which the data was drawn, anything from 12-22% of participants in the study reported some kind of adverse effect 4-6 days after undergoing a Shiatsu session, but that nothing at all to be concerned about because, when these effects were evaluated by the practitioners, they decided that 82% of the reports were ‘transitional effects’, the reasoning being that if you feel like shit a few days afterwards that proves that your last dose of woo is working.

now, you might argue that conventional medicines can have side effects but conventional medicines also have both evidence to demonstrate that they work that doesn’t rely on interpreting side effects as evidence of they efficacy and doctors don’t bullshit their patients by telling them not to worry about the side effect because that just proves that the treatment is working. What is crap about ‘transitional effects’ amounts to is equivalent to an oncologist telling a cancer patient who’s just received chemotherapy not to worry about their hair falling out as this proves that their cancer is going into remission.

That’s the standard of both the research and general ethical standards we’re dealing with here.

The other is referred to as a ‘systematic evidence review‘ but as the researcher struggled to find much evidence relating to Shiatsu (only 5 studies) they decided to throw in 22 studies of acupressure on top, just to give them something to review.

According the site, this study “critically appraises 5 scientific trials of Shiatsu”, which turn out, when you read the full paper, to be three uncontrolled studies and two ‘quasi-experimental’ studies, none of which could be pooled as each of them looked at the use of Shiatsu for a different condition and all of them failed to provide any evidence of a beneficial outcome, not even something that could be accounted for simply as a placebo effect…

…and these were the studies that passed the appraisal for inclusion in the review – there were 13 others that failed and were excluded.

This is the kind of thing that the CNHC has been set up to ‘regulate’… well, sort of ‘regulate’, if that’s what you can call what it actually does.

The thing is that registration with the CNCH is entirely voluntary, so no one is under any compulsion to sign up even if their particular brand of woo is one of the one’s that the CNHC is ostensibly supposed to ‘regulate’, so not signing up makes absolutely no difference whatsoever as to whether you can call yourself by a particular title or practice or inflict a particular variety of woo on your punters.

If you do sign up then you are supposed to abide by the CNHC’s code of conduct and if you don’t you can be ejected from its register, all of which has no bearing whatsoever on whether or not you can continue to call yourself by a particular title and inflict a particular variety of woo on your punters.

As regulatory systems go, this one is about much use as a chocolate teapot, and that’s before we get to the laughable code of conduct, which is where we’re heading next.

It’s a little difficult to say quite what could be considered the most ridiculous statement in the code of conduct but I have to say that this one is my own personal favourite:

You must get informed consent to give treatment (except in an emergency)

I must admit that I am really struggling to think of any possible emergency situation in which anyone of sound mind and body would ring their alternative therapist instead of calling 999.

“Damn it! I’ve just caught my hand in the bacon slicer. Quick, send for my naturopath”

I suspect (and sincerely hope) that the bit about ‘except in an emergency’ is completely redundant and was thrown in solely to add to the thin veneer of legitimacy that the CNHC are trying to artificially engineer, which is what all this is really about.

Getting back to the contents of the ‘code of conduct’, what do you reckon is has to say on the subject of evidence?

If you guessed ‘nothing’ then you’d be correct. Quacktitioners signing up to this sham ‘regulator’ are told only that, under provisions which require them to act within ‘the limits of their knowledge, skills and experience’, they must “only provide the treatment or advice if [they] believe this is appropriate”.

And if those beliefs have no basis or foundations in reality?

It doesn’t matter.

All that matters is how successfully the manage to themselves off from the real world behind an edifice constructed from bullshit and all the complex ethical and legal questions that they might otherwise face disappear into the aether.

They’re also told, somewhat hilariously that:

You must limit your work or stop practising if your performance or judgement is affected by your physical, emotional or mental health

But not, obvious, if they performance or judgment is limited by near absolute self-deception, and that to cap it all off, the last two clauses of the code of conduct warn quacktitioners that:

13. You must carry out your duties in a professional and ethical way.

You must carry out your duties and responsibilities in a professional and ethical way. Patients, clients and users are entitled to receive good and safe standards of practice and care. The CNHC seeks to protect the public from unprofessional and unethical behaviour, and to make sure that registrants know the standards expected of them.

14. You must behave with integrity and honesty.

You must make sure that you behave with integrity and honesty and keep to high standards of personal and professional conduct at all times.

Yeah, right…

Let’s deal with in the form of a question…

When when a punter wanders in to see the CNHC registered quacktitioner and presents them with a vague collection of symptoms to work with, will the quacktitioner?

a) treat the patient in an honest and ethical manner, sit them down and explain to them that they haven’t first fucking clue what the problem is and even if they did there’s no evidence to show that their particular brand of woo will be any more helpful than a good chat and sugar pill, or

b) tell them the chakras are obviously blocked, regale them with a bunch of quasi-mystical bullshit for half an hour and then tell them to pop back next week for their first course of ‘treatment’ and hand them a bill for £60.

In any other arena, but for religion – churches are the biggest con-artists of the lot – we’d be calling this fraud and sending the Rozzers round to have a word, not handing over public money to help them shore up the wall of bullshit that been steadily falling to pieces in recent years, even since doctors and scientists starting calling them out and asking them to provide evidence to support their claims.

Mind you, if you really want something to laugh at in all this, then nothing quite tops the message sent to the CNHC by Health Minister, Ben Bradshaw:”

I welcome the opening of the Complementary and Natural Healthcare Council (CNHC) register. Now that the Council is open for business, there will be a single voluntary registration body encompassing a wide range of complementary and alternative therapies, to which the public can turn for help.

“Members of the public who use these therapies will be able to check whether the practitioner they’re seeing is registered with the CNHC. If they are, they have the reassurance of knowing that they have had to meet minimum standards of qualification and that they have signed up to a rigorous code of conduct. Practitioners too will benefit by increased public confidence.

“Public safety is paramount. Registration, whether voluntary or statutory, is about protecting patients, and I am pleased to see this important milestone in voluntary registration. People should always seek their GP’s advice to ensure that any other therapy they use does not conflict with orthodox treatment”

Quacktitioners will what, Ben? “Benefit by increased public confidence”?

So you’re not just handing over public money to set up this whole sham, you’re actually happy for the Department of Health to play an active part in facilitating the con?

I swear, there are days when even ‘cunt’ isn’t enough to cover it.