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The consistent failure of ‘regulators’ to do their job has been a constant theme on this blog. There is a synopsis of dozens of them at Regulation of alternative medicine: why it doesn’t work, and never can. And it isn’t only quackery where this happens. The ineptitude (and extravagance) of the Quality Assurance Agency (QAA) was revealed starkly when the University of Wales’ accreditation of external degrees was revealed (by me and by BBC TV Wales, not by the QAA) to be so bad that the University had to shut down.

Here is another example that you couldn’t make up.

psa logo
cnhc-logo

 

Yes, the Professional Standards Authority (PSA) has agreed to accredit that bad-joke pseudo-regulator, the Complementary & Natural Healthcare Council (CNHC, more commonly known as Ofquack)

Ofquack was created at the instigation of HRH the Prince of Wales, at public expense, as a means of protecting the delusional beliefs of quacks from criticism. I worked for them for a while, and know from the inside that their regulation is a bad joke.

When complaints were made about untrue claims made by ‘reflexologists’, the complaints were upheld but they didn’t even reach the Conduct and Competence committee, on the grounds that the reflexologists really believed the falsehoods that they’d been taught. Therefore, by the Humpty Dumpty logic of the CNHC, their fitness to practise was not affected by their untrue claims. You can read the account of this bizarre incident by the person who submitted the complaints, Simon Perry.

In fact in the whole history of the CNHC, it has received a large number of complaints, but  only one has ever  been considered by their Conduct and Competence Committee.  The rest have been dismissed before they were considered properly.  That alone makes their claim to be a regulator seem ridiculous.

The CNHC did tell its registrants to stop making unjustified claims, but it has been utterly ineffective in enforcing that ruling. In May 2013, another 100 complaints were submitted and no doubt they will be brushed aside too: see Endemic problems with CNHC registrants..

As I said at the time

It will be fascinating to see how the CNHC tries to escape from the grave that it has dug for itself.

If the CNHC implements properly its own code of conduct, few people will sign up and the CNHC will die. If it fails to implement its own code of conduct it would be shown to be a dishonest sham.

In February of this year (2013), I visited the PSA with colleagues from the Nightingale Collaboration. We were received cordially enough, but they seemed to be bureaucrats with no real understanding of science. We tried to explain to them the fundamental dilemma of the regulation of quacks, namely that no amount of training will help when the training teaches things that aren’t true. They were made aware of all of the problems described above. But despite that, they ended up endorsing the CNHC.

How on earth did the PSA manage to approve an obviously ineffective ‘regulator’?

The job of the PSA is said to be “. . . protecting users of health and social care services and the public”. They (or at least their predecessor, the CHRE), certainly didn’t do that during the saga of the General Chiropractic Council.

The betrayal of reason is catalogued in a PSA document [get local copy]. Here is some nerdy detail.

It is too tedious to go through the whole document, so I’ll deal with only two of its many obvious flaws, the sections that deal with the evidence base, and with training.

The criteria for accreditation state

Standard 6: the organisation demonstrates that there is a defined knowledge base underpinning the health and social care occupations covered by its register or, alternatively, how it is actively developing one. The organisation makes the defined knowledge base or its development explicit to the public.

The Professional Standards Authority recognises that not all disciplines are underpinned by evidence of proven therapeutic value. Some disciplines are subject to controlled randomized trials, others are based on qualitative evidence.  Some rely on anecdotes. Nevertheless, these disciplines are legal and the public choose to use them. The Authority requires organisations to make the knowledge base/its development clear to the public so that they may make informed decisions.

Since all 15 occupations that are “regulated” by the CNHC fall into the last category. they “rely on anecdotes”, you would imagine the fact that “The Authority requires organisations to make the knowledge base/its development clear to the public” would mean that the CNHC was required to make a clear statement that reiki, reflexology etc are based solely on anecdote. Of course the CNHC does no such thing. For example, the CNHC’s official definition of reflexology says

Reflexology is a complementary therapy based on the belief that there are reflex areas in the feet and hands which are believed to correspond to all organs and parts of the body

There is, of course, not the slightest reason to think such connections exist, but the CNHC gives no hint whatsoever of that inconvenient fact. The word “anecdote” is used by the PSA but occurs nowhere on the CNHC’s web site.

It is very clear that the CNHC fails standard 6.

But the PSA managed to summon up the following weasel words to get around this glaring failure:

“The professional associations (that verify eligibility for CNHC registration) were actively involved in defining the knowledge base for each of the 15 professions. The Panel further noted that Skills for Health has lead responsibility for writing and reviewing the National Occupational Standards (NOS) for the occupations CNHC registers and that all NOS have to meet the quality criteria set by the UK Commission for Employment and Skills (UKCES), who are responsible for the approval of all NOS across all industry sectors. The Panel considered evidence provided and noted that the applicant demonstrated that there is a defined knowledge base underpinning the occupations covered by its registers. The knowledge base was explicit to the public”.

The PSA, rather than engaging their own brains, simply defer to two other joke organisations, Skills for Health and National Occupational Standards. But it is quite obvious that for things like reiki, reflexology and craniosacral therapy, the “knowledge base” consists entirely of made-up nonsense. Any fool can see that (but not, it seems, the PSA).

Skills for Health lists made-up, HR style, “competencies” for everything under the sun. When I got them to admit that their efforts on distance-healing etc had been drafted by the Prince of Wales’ Foundation, the conversation with Skills for Health became surreal (recorded in January 2008)

DC. Well yes the Prince of Wales would like that. His views on medicine are well known, and they are nothing if not bizarre. Haha are you going to have competencies in talking to trees perhaps?

“You’d have to talk to LANTRA, the land-based organisation for that.”

DC. I’m sorry, I have to talk to whom?

“LANTRA which is the sector council for the land-based industries uh, sector, not with us sorry . . . areas such as horticulture etc.”

DC. We are talking about medicine aren’t we? Not horticulture.

“You just gave me an example of talking to trees, that’s outside our remit ”

You couldn’t make it up, but it’s true. And the Professional Standards Authority rely on what these jokers say.

The current Skills for Health entry for reflexology says

“Reflexology is the study and practice of treating reflex points and areas in the feet and hands that relate to corresponding parts of the body. Using precise hand and finger techniques a reflexologist can improve circulation, induce relaxation and enable homeostasis. These three outcomes can activate the body’s own healing systems to heal and prevent ill health.”

This is crass, made-up nonsense. Of course there are no connections between “areas in the feet and hands that relate to corresponding parts of the body” and no reason to think that reflexology is anything more than foot massage. That a very expensive body, paid for by you and me, can propagate such preposterous nonsense is worrying. That the PSA should rely on them is even more worrying.

National Occupational Standards is yet another organisation that is utterly dimwitted about medical matters, but if you look up reflexology you are simply referred to Skills for Health, as above.

UK Commission for Employment and Skills
(UKCES)
is a new one on me. The PSA says that “the UK Commission for Employment and Skills (UKCES), who are responsible for the approval of all NOS across all industry sectors” It is only too obvious that the UKCES leadership team have failed utterly to do their job when it comes to made-up medicine. None of them know much about medicine. It’s true that their chairman did once work for SmithKline Beecham, but as a marketer of Lucozade, a job which anyone with much knowledge of science would not find comfortable..

You don’t need to know much medicine to spot junk. I see no excuse for their failure.

The training problem.

The PSA’s criteria for accreditation say

Standard 9: education and training

The organisation:

9a) Sets appropriate educational standards that enable its registrants to practise competently the occupation(s) covered by its register. In setting its standards the organisation takes account of the following factors:

  • The nature and extent of risk to service users and the public
  • The nature and extent of knowledge, skill and experience required to provide
    service users and the public with good quality care

and later

9b) Ensures that registrants who assess the health needs of service users and provide any form of care and treatment are equipped to:

  • Recognise and interpret clinical signs of impairment
  • Recognise where a presenting problem may mask underlying pathologies
  • Have sufficient knowledge of human disease and social determinants of health to identify where service users may require referral to another health or social care professional.

Anyone who imagines for a moment that a reflexologist or a craniosacral therapist is competent to diagnose a subarachnoid haemorrhage or malaria must need their head examining. In any case, the CNHC has already admitted that their registrants are taught things that aren’t true, so more training presumably means more inculcation of myths.

So how does the PSA wriggle out of this? Their response started

“The Panel noted that practitioners must meet, as a minimum, the National Occupational Standards for safe and competent practice. This is verified by the professional associations, who have in turn provided written undertakings to CNHC affirming that there are processes in place to verify the training and skills outcomes of their members to the NOS”

Just two problems there. The NOS standards themselves are utterly delusional. And checking them is left to the quacks themselves. To be fair, the PSA weren’t quite happy with this, but after an exchange of letters, minor changes enabled the boxes to be ticked and the PSA said “The Panel was now satisfied from the evidence provided, that this Standard had been
met”.

What’s wrong with regulators?

This saga is typical of many other cases of regulators doing more harm than good. Regulators are sometimes quacks themselves, in which case one isn’t surprised at their failure to regulate.

But organisations like the Professional Standards Authority and Skills for Health are not (mostly) quacks themselves. So how do they end up giving credence to nonsense? I find that very hard to comprehend, but here are a few ideas.

(1) They have little scientific education and are not really capable of critical thought

(2) Perhaps even more important, they lack all curiosity. It isn’t very hard to dig under the carapace of quack organisations, but rather than finding out for themselves, the bureaucrats of the PSA are satisfied by reassuring letters that allow them to tick their boxes and get home.

(3) A third intriguing possibility is that people like the PSA yield to political pressure. The Department of Health is deeply unscientific and clearly has no idea what to do about alternative medicine. They have still done nothing at all about herbal medicine, traditional Chinese medicine or homeopathy, after many years of wavering. My guess is that they see the CNHC as an organisation that gives the appearance that they’ve done something about reiki etc. I wonder whether they applied pressure to the PSA to accredit CNHC, despite it clearly breaking their own rules. I have sent a request under the Freedom of Information Act in an attempt to discover if the Department of Health has misbehaved in the way it did when it attempted to override NHS Choices.

The responsibility for this cock-up has to rest squarely on the shoulders of the PSA’s director, Harry Cayton. He was director of the CHRE from which PSA evolved and is the person who so signally failed to do anything about the General Chiropractic Council fiasco,

What can be done?

This is just the latest of many examples of regulators who not only fail to help but actually do harm by giving their stamp of approval to mickey mouse organisations like the CNHC. Most of the worst quangos survived the “bonfire of the quangos”.. The bonfire should have started with the PSA, CNHC and Skills for Health. They cost a lot and do harm.

There is a much simpler answer. There is a good legal case that much of alternative medicine is illegal. All one has to do is to enforce the existing law. Nobody would object to quacks if they stopped making false claims (though whether they could stay in business if they stopped exaggerating is debatable). There is only one organisation that has done a good job when it comes to truthfulness. That is the Advertising Standards Authority. But the ASA can do nothing apart from telling people to change the wording of their advertisements, and even that is often ignored.

The responsibility for enforcing the Consumer Protection Law is Trading Standards. They have consistently failed to do their job (see Medico-Legal Journal, Rose et al., 2012. “Spurious Claims for Health-care Products“.

If they did their job of prosecuting people who defraud the public with false claims, the problem would be solved.

But they don’t, and it isn’t.

Follow-up

The indefatigable Quackometer has wriiten an excellent account of the PSA fiasco

Jump to follow-up

The Scottish Universities Medical Journal asked me to write about the regulation of alternative medicine. It’s an interesting topic and not easy to follow because of the veritable maze of more than twenty overlapping regulators and quangos which fail utterly to protect the public against health fraud. In fact they mostly promote health fraud. The paper is now published, and here is a version with embedded links (and some small updates).

We are witnessing an increasing commercialisation of medicine. It’s really taken off since the passage of the Health and Social Security Bill into law. Not only does that mean having NHS hospitals run by private companies, but it means that “any qualified provider” can bid for just about any service.  The problem lies, of course, in what you consider “qualified” to mean.  Any qualified homeopath or herbalist will, no doubt, be eligible.  University College London Hospital advertised for a spiritual healer. The "person specification" specified a "quallfication", but only HR people think that a paper qualification means that spiritual healing is anything but a delusion.

uclh-spirit

The vocabulary of bait and switch

First, a bit of vocabulary.  Alternative medicine is a term that is used for medical treatments that don’t work (or at least haven’t been shown to work).  If they worked, they’d be called “medicine”.  The anti-malarial, artemesinin, came originally from a Chinese herb, but once it had been purified and properly tested, it was no longer alternative.  But the word alternative is not favoured by quacks.  They prefer their nostrums to be described as “complementary” –it sounds more respectable.  So CAM (complementary and alternative medicine became the politically-correct euphemism.  Now it has gone a stage further, and the euphemism in vogue with quacks at the moment is “integrated” or “integrative” medicine.  That means, very often, integrating things that don’t work with things that do.  But it sounds fashionable.  In reality it is designed to confuse politicians who ask for, say, integrated services for old people.

Put another way, the salespeople of quackery have become rather good at bait and switch. The wikepedia definition is as good as any.

Bait-and-switch is a form of fraud, most commonly used in retail sales but also applicable to other contexts. First, customers are “baited” by advertising for a product or service at a low price; second, the customers discover that the advertised good is not available and are “switched” to a costlier product.

As applied to the alternative medicine industry, the bait is usually in the form of some nice touchy-feely stuff which barely mentions the mystical nonsense. But when you’ve bought into it you get the whole panoply of nonsense. Steven Novella has written eloquently about the use of bait and switch in the USA to sell chiropractic, acupuncture, homeopathy and herbal medicine: "The bait is that CAM offers legitimate alternatives, the switch is that it primarily promotes treatments that don’t work or are at best untested and highly implausible.".

The "College of Medicine" provides a near-perfect example of bait and switch. It is the direct successor of the Prince of Wales’ Foundation for Integrated Health. The Prince’s Foundation was a consistent purveyor of dangerous medical myths. When it collapsed in 2010 because of a financial scandal, a company was formed called "The College for Integrated Health". A slide show, not meant for public consumption, said "The College represents a new strategy to take forward the vision of HRH Prince Charles". But it seems that too many people have now tumbled to the idea that "integrated", in this context, means barmpottery. Within less than a month, the new institution was renamed "The College of Medicine". That might be a deceptive name, but it’s a much better bait. That’s why I described the College as a fraud and delusion.

Not only did the directors, all of them quacks, devise a respectable sounding name, but they also succeeded in recruiting some respectable-sounding people to act as figureheads for the new organisation. The president of the College is Professor Sir Graham Catto, emeritus professor of medicine at the University of Aberdeen. Names like his make the bait sound even more plausible. He claims not to believe that homeopathy works, but seems quite happy to have a homeopathic pharmacist, Christine Glover, on the governing council of his college. At least half of the governing Council can safely be classified as quacks.

So the bait is clear. What about the switch? The first thing to notice is that the whole outfit is skewed towards private medicine: see The College of Medicine is in the pocket of Crapita Capita. The founder, and presumably the main provider of funds (they won’t say how much) is the huge outsourcing company, Capita. This is company known in Private Eye as Crapita. Their inefficiency is legendary. They are the folks who messed up the NHS computer system and the courts computer system. After swallowing large amounts of taxpayers’ money, they failed to deliver anything that worked. Their latest failure is the court translation service.. The president (Catto), the vice president (Harry Brunjes) and the CEO (Mark Ratnarajah) are all employees of Capita.

The second thing to notice is that their conferences and courses are a bizarre mixture of real medicine and pure quackery. Their 2012 conference had some very good speakers, but then it had a "herbal workshop" with Simon Mills (see a video) and David Peters (the man who tolerates dowsing as a way to diagnose which herb to give you). The other speaker was Dick Middleton, who represents the huge herbal company, Schwabe (I debated with him on BBC Breakfast), In fact the College’s Faculty of Self-care appears to resemble a marketing device for Schwabe.

Why regulation isn’t working, and can’t work

There are various levels of regulation. The "highest" level is the statutory regulation of osteopathy and chiropractic. The General Chiropractic Council (GCC) has exactly the same legal status as the General Medical Council (GMC). This ludicrous state of affairs arose because nobody in John Major’s government had enough scientific knowledge to realise that chiropractic, and some parts of osteopathy, are pure quackery,

The problem is that organisations like the GCC function more to promote chiropractic than to regulate them. This became very obvious when the British Chiropractic Association (BCA) decided to sue Simon Singh for defamation, after he described some of their treatments as “bogus”, “without a jot of evidence”.

In order to support Singh, several bloggers assessed the "plethora of evidence" which the BCA said could be used to justify their claims. When, 15 months later, the BCA produced its "plethora" it was shown within 24 hours that the evidence was pathetic. The demolition was summarised by lawyer, David Allen Green, in The BCA’s Worst Day.

In the wake of this, over 600 complaints were made to the GCC about unjustified claims made by chiropractors, thanks in large part to heroic work by two people, Simon Perry and Allan Henness. Simon Perry’s Fishbarrel (browser plugin) allows complaints to be made quickly and easily -try it). The majority of these complaints were rejected by the GCC, apparently on the grounds that chiropractors could not be blamed because the false claims had been endorsed by the GCC itself.

My own complaint was based on phone calls to two chiropractors, I was told such nonsense as "colic is down to, er um, faulty movement patterns in the spine". But my complaint  never reached the Conduct and Competence committee because it had been judged by a preliminary investigating committee that there was no case to answer. The impression one got from this (very costly) exercise was that the GCC was there to protect chiropractors, not to protect the public.

The outcome was a disaster for chiropractors, wno emerged totally discredited. It was also a disaster for the GCC which was forced to admit that it hadn’t properly advised chiropractors about what they could and couldn’t claim. The recantation culminated in the GCC declaring, in August 2010, that the mythical "subluxation" is a "historical concept " "It is not supported by any clinical research evidence that would allow claims to be made that it is the cause of disease.". Subluxation was a product of the fevered imagination of the founder of the chiropractic cult, D.D. Palmer. It referred to an imaginary spinal lesion that he claimed to be the cause of most diseases. .Since ‘subluxation’ is the only thing that’s distinguished chiropractic from any other sort of manipulation, the admission by the GCC that it does not exist, after a century of pretending that it does, is quite an admission.

The President of the BCA himself admitted in November 2011

“The BCA sued Simon Singh personally for libel. In doing so, the BCA began one of the darkest periods in its history; one that was ultimately to cost it financially,”

As a result of all this, the deficiencies of chiropractic, and the deficiencies of its regulator were revealed, and advertisements for chiropractic are somewhat less misleading. But this change for the better was brought about entirely by the unpaid efforts of bloggers and a few journalists, and not at all by the official regulator, the GCC. which was part of the problem. not the solution. And it was certainly not helped by the organisation that is meant to regulate the GCC, the Council for Health Regulatory Excellence (CHRE) which did nothing whatsoever to stop the farce.

At the other end of the regulatory spectrum, voluntary self-regulation, is an even worse farce than the GCC. They all have grand sounding "Codes of Practice" which, in practice, the ignore totally.

The Society of Homeopaths is just a joke. When homeopaths were caught out recommending sugar pills for prevention of malaria, they did nothing (arguably such homicidal advice deserves a jail sentence).

The Complementary and Natural Healthcare Council (CNHC) is widely know in the blogosphere as Ofquack. I know about them from the inside, having been a member of their Conduct and Competence Committee, It was set up with the help of a £900,000 grant from the Department of Health to the Prince of Wales, to oversee voluntary self-regulation. It fails utterly to do anything useful.. The CNHC code of practice, paragraph 15 , states

“Any advertising you undertake in relation to your professional activities must be accurate. Advertisements must not be misleading, false, unfair or exaggerated”. 

When Simon Perry made a complaint to the CNHC about claims being made by a CNHC-registered reflexologist, the Investigating Committee upheld all 15 complaints.  But it then went on to say that there was no case to answer because the unjustified claims were what the person had been taught, and were made in good faith. 
This is precisely the ludicrous situation which will occur again and again if reflexologists (and many other alternative therapies) are “accredited”.  The CNHC said, correctly, that the reflexologist had been taught things that were not true, but then did nothing whatsoever about it apart from toning down the advertisements a bit. They still register reflexologists who make outrageously false claims.

Once again we see that no sensible regulation is possible for subjects that are pure make-believe.

The first two examples deal (or rather, fail to deal) with regulation of outright quackery. But there are dozens of other quangos that sound a lot more respectable.

European Food Standards Agency (EFSA). One of the common scams is to have have your favourite quack treatment classified as a food not as a medicine. The laws about what you can claim have been a lot laxer for foods. But the EFSA has done a pretty good job in stopping unjustified claims for health benefits from foods. Dozens of claims made by makers of probiotics have been banned. The food industry, needless to say, objects very strongly to be being forced to tell the truth. In my view, the ESFA has not gone far enough. They recently issued a directive about claims that could legally be made. Some of these betray the previously high standards of the EFSA. For example you are allowed to say that "Vitamin C contributes to the reduction of tiredness and fatigue" (as long as the product contains above a specified amount of Vitamin C. I’m not aware of any trials that show vitamin C has the slightest effect on tiredness or fatigue, Although these laws do not come into effect until December 2012, they have already been invoked by the ASA has a reason not to uphold a complaint about a multivitamin pill which claimed that it “Includes 8 nutrients that can contribute to the reduction in tiredness and fatigue”

The Advertising Standards Authority (ASA). This is almost the only organisation that has done a good job on false health claims. Their Guidance on Health Therapies & Evidence says

"Whether you use the words ‘treatment’, ‘treat’ or ‘cure’, all are likely to be seen by members of the public as claims to alleviate effectively a condition or symptom. We would advise that they are not used"

"Before and after’ studies with little or no control, studies without human subjects, self-assessment studies and anecdotal evidence are unlikely to be considered acceptable"

"Before and after’ studies with little or no control, studies without human subjects, self-assessment studies and anecdotal evidence are unlikely to be considered acceptable"

They are spot on.

The ASA’s Guidance for Advertisers of Homeopathic Services is wonderful.

"In the simplest terms, you should avoid using efficacy claims, whether implied or direct,"

"To date, the ASA has have not seen persuasive evidence to support claims that homeopathy can treat, cure or relieve specific conditions or symptoms."

That seems to condemn the (mis)labelling allowed by the MHRA as breaking the rules.. Sadly, though, the ASA has no powers to enforce its decisions and only too often they are ignored. The Nightingale collaboration has produced an excellent letter that you can hand to any pharmacist who breaks the rules

The ASA has also judged against claims made by "Craniosacral therapists" (that’s the lunatic fringe of osteopathy). They will presumably uphold complaints about similar claims made (I’m ashamed to say) by UCLH Hospitals.

The private examination company Edexcel sets exams in antiscientific subjects, so miseducating children. The teaching of quackery to 16 year-olds has been approved by a maze of quangos, none  of which will take responsibility, or justify their actions. So far I’ve located no fewer than eight of them. The Office of the Qualifications and Examinations Regulator (OfQual), Edexcel, the Qualifications and Curriculum Authority (QCA), Skills for Health, Skills for Care, National Occupational Standards (NOS), private exam company VTCT and the schools inspectorate, Ofsted.. Asking any of these people why they approve of examinations in imaginary subjects meets with blank incomprehension. They fail totally to protect tha public from utter nonsense.

The Department of Education has failed to do anything about the miseducation of children in quackery. In fact it has encouraged it by, for the first time, giving taxpayers’ money to a Steiner (Waldorf) school (at Frome, in Somerset). Steiner schools are run by a secretive and cult-like body of people (read about it). They teach about reincarnation, karma, gnomes, and all manner of nonsense, sometimes with unpleasant racial overtones. The teachers are trained in Steiner’s Anthroposophy, so if your child gets ill at school they’ll probably get homeopathic sugar pills. They might well get measles or mumps too, since Steiner people don’t believe in vaccination.

Incredibly, the University of Aberdeen came perilously close to appointing a chair in anthroposophical medicine. This disaster was aborted by bloggers, and a last minute intervention from journalists. Neither the university’s regulatory mechanisms. nor any others, seemed to realise that a chair in mystical barmpottery was a bad idea.

Trading Standards offices and the Office of Fair Trading.

It is the statutory duty of Trading Standards to enforce the Consumer Protection Regulations (2008) This European legislation is pretty good. it caused a lawyer to write " Has The UK Quietly Outlawed “Alternative” Medicine?". Unfortunately Trading Standards people have consistently refused to enforce these laws. The whole organisation is a mess. Its local office arrangement fails totally to deal with the age of the internet. The situation is so bad that a group of us decided to put them to the test. The results were published in the Medico-Legal Journal, Rose et al., 2012. "Spurious Claims for Health-care Products: An Experimental Approach to Evaluating Current UK Legislation and its Implementation". They concluded "EU directive 2005/29/EC is
largely ineffective in preventing misleading health claims for consumer products in
the UK"

Skills for Health is an enormous quango which produces HR style "competences" for everything under the son. They are mostly quite useless. But those concerned with alternative medicine are not just useless. They are positively harmful. Totally barmy. There are competences and National Occupational Standards for every lunatic made-up therapy under the sun. When I phoned them to discover who’d written them, I learned that the had been drafted by the Prince of Wales’ Foundation for Magic Medicine. And when I joked by asking if they had a competence for talking to trees, I was told, perfectly seriously, “You’d have to talk to LANTRA, the land-based organisation for that.”

That was in January 2008. A lot of correspondence with the head of Skills for Health got nowhere at all. She understood nothing and it hasn’t improved a jot.

This organisation costs a lot of taxpayers’ money and it should have been consigned to the "bonfire of the quangos" (but of course there was no such bonfire in reality). It is a disgrace.

The Quality Assurance Agency (QAA) is supposed to ensure the quality of university courses. In fact it endorses courses in nonsense alternative medicine and so does more harm than good. The worst recent failure of the QAA was in the case of the University of Wales: see Scandal of the University of Wales and the Quality Assurance Agency. The university was making money by validating thousands of external degrees in everything from fundamentalist theology to Chinese Medicine. These validations were revealed as utterly incompetent by bloggers, and later by BBC Wales journalist Ciaran Jenkins (now working for Channel 4).

The mainstream media eventually caught up with bloggers. In 2010, BBC1 TV (Wales) produced an excellent TV programme that exposed the enormous degree validation scam run by the University of Wales. The programme can be seen on YouTube (Part 1, and Part 2). The programme also exposed, incidentally, the uselessness of the Quality Assurance Agency (QAA) which did nothing until the scam was exposed by TV and blogs. Eventually the QAA sent nine people to Malaysia to investigate a dodgy college that had been revealed by the BBC. The trip cost £91,000. It could have been done for nothing if anyone at the QAA knew how to use Google.

The outcome was that the University of Wales stopped endorsing external courses, and it was soon shut down altogether (though bafflingly, its vice-chancellor, Marc Clement was promoted). The credit for this lies entirely with bloggers and the BBC. The QAA did nothing to help until the very last moment.

Throughout this saga Universities UK (UUK), has maintained its usual total passivity. They have done nothing whatsoever about their members who give BSc degrees in anti-scientific subjects. (UUK used to known as the Committee of Vice-Chancellors and Principals).

Council for Health Regulatory Excellence (CHRE), soon to become the PSAHSC,

Back now to the CHRE, the people who failed so signally to sort out the GCC. They are being reorganised. Their consultation document says

"The Health and Social Care Act 20122 confers a new function on the Professional Standards Authority for Health and Social Care (the renamed Council for Healthcare Regulatory Excellence). From November 2012 we will set standards for organisations that hold voluntary registers for people working in health and social care occupations and we will accredit the register if they meet those standards. It will then be known as an ‘Accredited Register’. "

They are trying to decide what the criteria should be for "accreditation" of a regulatory body. The list of those interested has some perfectly respectable organisations, like the British Psychological Society. It also contains a large number of crackpot organisations, like Crystal and Healing International, as well as joke regulators like the CNHC.

They already oversee the Health Professions Council (HPC) which is due to take over Herbal medicine and Traditional Chinese Medicine, with predictably disastrous consequences.

Two of the proposed criteria for "accreditation" appear to be directly contradictory.

Para 2.5 makes the whole accreditation pointless from the point of view of patients

2.5 It will not be an endorsement of the therapeutic validity or effectiveness of any particular discipline or treatment.

Since the only thing that matters to the patient is whether the therapy works (and is safe), accrediting of organisations that ignore this will merely give the appearance of official approval of crystal healing etc etc. This appears to contradict directly

A.7 The organisation can demonstrate that there either is a sound knowledge base underpinning the profession or it is developing one and makes that explicit to the public.

A "sound knowledge base", if it is to mean anything useful at all, means knowledge that the treatment is effective. If it doesn’t mean that, what does it mean?

It seems that the official mind has still not grasped the obvious fact that there can be no sensible regulation of subjects that are untrue nonsense. If it is nonsense, the only form of regulation that makes any sense is the law.

Please fill in the consultation. My completed return can be downloaded as an example, if you wish.

Medicines and Healthcare products Regulatory Agency (MHRA) should be a top level defender of truth. Its strapline is

"We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe."

The MHRA did something (they won’t tell me exactly what) about one of the most cruel scams that I’ve ever encountered, Esperanza Homeopathic Neuropeptide, peddled for multiple sclerosis, at an outrageous price ( £6,759 for 12 month’s supply). Needless to say there was not a jot of evidence that it worked (and it wasn’t actually homeopathic).

Astoundingly, Trading Standards officers refused to do anything about it.

The MHRA admit (when pushed really hard) that there is precious little evidence that any of the herbs work, and that homeopathy is nothing more than sugar pills. Their answer to that is to forget that bit about "ensuring that medicines … work"

Here’s the MHRA’s Traditional Herbal Registration Certificate for devils claw tablets.

vitabiotics

The wording "based on traditional use only" has to be included because of European legislation. Shockingly, the MHRA have allowed them to relegate that to small print, with all the emphasis on the alleged indications. The pro-CAM agency NCCAM rates devil’s claw as "possibly effective" or "insufficient evidence" for all these indications, but that doesn’t matter because the MHRA requires no evidence whatsoever that the tablets do anything. They should, of course, added a statement to this effect to the label. They have failed in their duty to protect and inform the public by allowing this labelling.

But it gets worse. Here is the MHRA’s homeopathic marketing authorisation for the homeopathic medicinal product Arnicare Arnica 30c pillules

It is nothing short of surreal.

hom1
hom2

Since the pills contain nothing at all, they don’t have the slightest effect on sprains, muscular aches or bruising. The wording on the label is exceedingly misleading.

If you "pregnant or breastfeeding" there is no need to waste you doctor’s time before swallowing a few sugar pills.

"Do not take a double dose to make up for a missed one". Since the pills contain nothing, it doesn’t matter a damn.

"If you overdose . . " it won’t have the slightest effect because there is nothing in them

And it gets worse. The MHRA-approved label specifies ACTIVE INGREDIENT. Each pillule contains 30c Arnica Montana

No, they contain no arnica whatsoever.

hom3
hom4

It truly boggles the mind that men with dark suits and lots of letters after their names have sat for hours only to produce dishonest and misleading labels like these.

When this mislabeling was first allowed, it was condemned by just about every scientific society, but the MHRA did nothing.

The Nightingale Collaboration.

This is an excellent organisation, set up by two very smart skeptics, Alan Henness and Maria MacLachlan. Visit their site regularly, sign up for their newsletter Help with their campaigns. Make a difference.

Conclusions

The regulation of alternative medicine in the UK is a farce. It is utterly ineffective in preventing deception of patients.

Such improvements as have occurred have resulted from the activity of bloggers, and sometime the mainstream media. All the official regulators have, to varying extents, made things worse.

The CHRE proposals promise to make matters still worse by offering "accreditation" to organisations that promote nonsensical quackery. None of the official regulators seem to be able to grasp the obvious fact that is impossible to have any sensible regulation of people who promote nonsensical untruths. One gets the impression that politicians are more concerned to protect the homeopathic (etc, etc) industry than they are to protect patients.

Deception by advocates of alternative medicine harms patients. There are adequate laws that make such deception illegal, but they are not being enforced. The CHRE and its successor should restrict themselves to real medicine. The money that they spend on pseudo-regulation of quacks should be transferred to the MHRA or a reformed Trading Standards organisation so they can afford to investigate and prosecute breaches of the law. That is the only form of regulation that makes sense.

 

Follow-up

The shocking case of the continuing sale of “homeopathic vaccines” for meningitis, rubella, pertussis etc was highlighted in an excellent TV programme by BBC South West. The failure of the MHRA and the GPC do take any effective action is a yet another illustration of the failure of regulators to do their job. I have to agree with Andy Lewis when he concludes

“Children will die. And the fault must lie with Professor Sir Kent Woods, chairman of the regulator.”

Our undercover investigation finds evidence of nutritional therapists giving out advice that could seriously harm patients’ health

Jump to follow-up

That’s the title of an article in February’s Which? magazine. (That’s similar to Consumer Reports in the USA).

“When Which? sent researchers to investigate the quality of advice from nutritional therapists, some was so bad that patients’ health was put at risk. One nutritional therapist advised against surgery and radiotherapy to treat cancer, while another ‘diagnosed’ a problem with adrenal glands without any blood-test results. Some also used unproven testing, such as iridology or mineral testing, to identify problems or diagnose conditions.”

This sort of sting operation may seem a bit mean but there is no option. It’s the only way to discover what’s actually happening and it is very much in the public interest to know about that.

"Our panel of medical experts rated six of our 15 consultations as ‘dangerous fails’ – potentially endangering the health of our researchers – with a further eight rated as ‘fails’. Only one consultation of the 15 was deemed a borderline pass by our experts.”

which-1

"We sent five undercover researchers to visit three nutritional therapists each. Every researcher was equipped with a specific health-related scenario: Helen (46) and Sarah (40), recently diagnosed with Ductal Carcinoma In Situ (DCIS), the most common type of non-invasive breast cancer; Mark (56) and Linda (52), suffering with serious fatigue for the past three months; and Emily (31), trying unsuccessfully to conceive for more than a year."

 

Sarah, posing as a patient diagnosed with DCIS, visited a nutritional therapist who advised her to delay treatment recommended by her oncologist (a lumpectomy and a course of radiotherapy). The therapist suggested that Sarah follow a no-sugar diet for three to six months and told her, ‘cancer lives off sugar; if you feed it sugar it’s going to thrive. If we starve the cancer of sugar then you have a better opportunity of the cancer going away’.

When Sarah asked whether the cancer could progress during this time the therapist said it was a ‘gamble’.

Dr Margaret McCartney, from our panel of experts, says: ‘If cancer treatment were as simplistic as cutting out sugar, surely we would have discovered a cure. This advice is highly irresponsible.’ Our experts rated this consultation as a ‘dangerous fail’."

The Patients’ Guide to magic medicine defined “Nutritional therapy: self-styled ‘nutritionists’ making untrue claims about diet in order to sell you unnecessary supplements”. That turned out to be pretty accurate. They are part of the alternative medicine fringe.

The Universities Admission Service (UCAS) no longer lists any BSc/MSc degrees in "Nutritional Therapy" or "Nutritional medicine". Westminster University closed its BSc Nutritional Therapy during last year. We still don’t know the fate of the notorious (or should I say hilarious) course run at the Northern College of Acupuncture and validated (after a fashion) by the late University of Wales, but it isn’t listed for entry in 2012. [We do now: see follow-up‘]

But there are a large number of university courses called "Nutrition". How many of them teach properly, and how many of them teach the nonsense that prevails in "nutritional therapy", I don’t know. The term ‘nutrition’ has turned into a dangerous minefield. It can mean almost anything, because the term is undefined. Anyone can, and does, describe themselves as a nutritionist. At one extreme you have slick pills salesman like ‘not-a-Dr’ Gillian McKeith and Patrick Holford. At the other extreme you have a fascinating and respectable subject for study.

The one thing that you need to get clear is that if you want advice about nutrition, go to a dietitian not a "nutritionist". Dietitians are the properly qualified people who work in the NHS, and who are (mostly) free of crackpot ideas.

scores

methods

I suppose that one should not be surprised at the poor, and sometimes dangerous, advice that was given by nutritional therapists. Their training contains much nonsense so it isn’t surprising that they did so badly. Some of it has been revealed here. See, for example,

Another worthless validation: the University of Wales and nutritional therapy
Nutritional Fairy Tales from Thames Valley University
College of Natural Nutrition: bizarre teaching revealed
Nutriprofile: useful aid or sales scam? 
Response to a threatening letter from Mr Holford
Food for the Brain: Child Survey. A proper job?
Teaching bad science to children: OfQual and Edexcel are to blame
The last BSc (Hons) Homeopathy closes! But look at what they still teach at Westminster University.

The level of knowledge of both physiology and chemistry shown my some of the therapists was shocking. One recommended avoiding margarine, because it’s “two chemical bonds away from pure plastic”. Another said that Flora margarine contains lots of trans fat, which has not been true for a long time.

One graduate ot the late Thames Valley University course said “”advantage of the wholemeal or the wholegrain … is that they contain more fibre and the fibre stops the sugars being absorbed quite as quickly”. Not so. Brown and white bread have much the same glycaemic index (60 – 70).

Quack diagnosis

One alarming fact was that several therapists offered methods of diagnosis for allergy and for deficiencies that have been known for many years not to work. There isn’t anything controversial about iridology, hair mineral analysis, taste tests. kinesiology. or the Vega test. They are pure quackery.

“Professor David Colquhoun, from our panel of experts, said: ‘Sadly, nutritional therapy is plagued by “diagnostic tests” that are little more than quackery; they are tools to aid sales, rather than tools to diagnose deficiencies. Iridology and hair analysis simply don’t work.”

Unnecessary treatments

One therapist advised a researcher to have an optimum nutritional evaluation test, costing £312, and a cellular nutrition profile, costing £156. Apparently, these would allow the therapist to give a
more targeted service by establishing what vitamin and mineral deficiencies he had.
Our experts were not convinced by these tests and certainly didn’t think they were worth the money; any necessary testing
could be done by a GP for free.

In 12 of the 15 consultations, researchers were prescribed a huge range of supplements, costing up to £70 per month. It was not revealed whether or not the prescriber made money from this, but usually you were asked to give the prescriber’s name "to get a discount". So it’s a fair guess that they got kickbacks.

British Association for Applied Nutrition & Nutritional Therapy (BANT)

Despite the low standards of advice, 13 out of the 14 therapists who were visited were registered with BANT, the British Association for Applied Nutrition & Nutritional Therapy. This is what passes for a professional association for nutritional therapists, though like all such bodies in alternative medicine, it is entirely ineffective as a regulator. Rather it serves to protect whatever untrue claims they make. BANT’s code of practice says that its members won’t diagnose, but in fact many of the therapists diagnosed conditions and created treatment plans. You can be confident that BANT will do nothing to stop this bad practice.

You can find out a lot about BANT from these sources:

British Association for Nutritional Therapy – when an organisation looks like a regulator, quacks like a regulator, but isn’t a regulator
Why it is easy to get the incorrect impression that BANT is a regulator
Nutritional Therapists Fail to Join Ofquack
BANT: A Profile
Matthias Rath drops his million pound legal case against me and the Guardian.

Only 3 of the 14 therapists were registered with the Complementary and Natural Healthcare Council (the CNHC, more commonly know as Ofquack). They are meant to be the official regulator, launched with a good chunk of taxpayers’ money, but registration is voluntary and not many have volunteered. As a requlator, Ofquack is a bad joke.

Conclusion

"Dr Margaret McCartney says: ‘This investigation appears to show that high street nutritional therapists are a waste of money. If you have symptoms please see your GP, not someone who can’t diagnose accurately.’ If you’re looking for tailored dietary advice, visit a registered dietitian.
"

There is a discussion of this topic on the Which? magazine site.

Follow-up

The excellent Quackometer has posted simultaneously on the great nutritional therapy scam.

16 January 2012 The British Dietetic Association issued a press release that describes very clearly the many differences between a real dietitian and a "nutritional therapist". Download Leading UK Nutrition Association Urges Awareness Between Dietitians and Nutritionists (pdf).

16 January 2012 BANT issued a press release. Download Are Nutritional Therapists Gambling with Your Health?. It answers none of the serious questions raised by the Which? investigation.   BANT moans that that Which?  “did not provide all the promised transcripts/questionnaires in a timely fashion”.   In fact they got them before Christmas and were given until January 15th to respond.

16 January 2012. BBC Radio 4 programme, You and Yours, had an item with Jenny Driscoll from Which? magazine and BANT chairperson, Catherine Honeywell. She did, inter alia, admit that some of the behaviour of the therapists were irresponsible. It remains to be seen if they do anything about it. don’t hold your breath. Hear it on BBC iPlayer.

16 January 2012. There was pretty god coverage of the story, even in the Daily Mail.

17 January 2012 Another question answered. I just learned that the ludicrous course in Nutritional Therapy, previously validated by the University of Wales (and a contributor to its downfall), is now being validated by, yes, you guessed, Middlesex University. Professor Driscoll seems determined to lead his univerity to the bottom of the academic heap. His new partnership with the Northern college of Acupuncture is just one of a long list of validations that almost rivals that of the late University of Wales. The course has, of course, an enthusiastic testimonial, from a student. It starts

I work full time as a team leader for a pension company but I am also a kinesiologist and work in my spare time doing kinesiology, reiki and Indian head massage.

Evidently she’s a believer in the barmiest and totally disproved forms of magic medicine. And Middlesex University will give her a Master of Science degree. I have to say I find it worrying that she’s a team leader for a pension company. Does she also believe in the value of worthless derivatives. I wonder?

17 January 2012 The discussion is going on at the Which? web site. A Chris James cast doubt on the reaults because ot the small sample size, and asked for confidence limits, so I gave them.

Chris James

It is easy enough to calculate limits yourself -you don’t even need to be able to do the maths -there are web calculators that do it for you, e.g. http://www.causascientia.org/math_stat/ProportionCI.html

14/15 = 93% failed. 95% confidence limits for this are 69.8% to 98.4%

6/15 = 40% gave dangerous advice 95% confidence limits 19.7% to 64.6%

So despite the small sample size we can say that it’s likely that at least 70% (and possibly 98%) of nutritional therapists fail.

And it is likely that at least 20% (and possibly 65%) of nutritional therapists give dangerous advice.

These results give real cause for concern, despite the small sample size.

For statistical enthusiasts, these limits are Bayesian with a uniform prior. Very much the same result is given by the standard analysis which is explained in section 7.7 of Lectures on Biostatistics [download pdf 10.5 Mb]

18 January 2012. BANT has, at last, produced an “updated response”. The good thing is that it starts by saying

” . . it is completely outside the BANT Code of Practice to advise a client to withhold any treatment for cancer for any period of time in order to follow a nutritional approach. Were a client to be advised in such a way we would expect to receive a complaint against the practitioner.”

I hope that this will happen. This statement, the only admission of guilt in BANT’s response, is rather spoiled by a later suggestion that no such recommendation was made. It looked very clear to both Which? magazine and to the three members of the expert panel.

The rest of the response admits no fault of any sort.

I’m sorry to say that the response by BANT shows very clearly what is wrong in nutritional therapy. Any organisation which can see nothing wrong in the advice given in 14 of the 15 consultations is, I’d argue, a threat to the health of the nation. Rather than saying we’ll try to improve, they just deny everything.

The response seems to show that the professional organisation for nutritional therapists is not part of the solution. Rather it is part of the problem.

Jump to follow-up

I hate to be forced to return to the world’s most boring delusion, homeopathy. It is boring because the battle to inform people how daft it is has been almost won. Now not a single Bachelors degree in homeopathy appears in UCAS, compared with at least five in 2007. But the battle is not quite won with the UK Government. This post is not so much about homeopathy as about the failures of the Government and the MHRA.

The Medicines and Health Regulatory Authority (MHRA), has just launched yet another consultation and I have felt obliged to waste an entire Sunday writing a response to it, I can’t imagine that any scientist would disagree much with what I have written, but most of them have far better ways to spend their time than bothering about the lunatic fringes of medicine. No doubt most of the responses will come from people who make money from homeopathy, Not just the homeopaths on the High Street, but also the very rich companies like Boiron and Weleda who make enormous profits from selling pills that contain nothing but a bit of sugar.

The documents

The consultation concerns what should be done, about homeopathy in the wake of the scarifying report of the House of Commons Select Committee [get pdf], and the governments response to that report [get pdf].

The MHRA’s request for consultation is here. Download the consultation document. You can download my full response [get pdf], Please write your own response and send it to andreafarmer@mhra.gsi.gov.uk before February 17th. Feel free to plagiarise anything you find here.

Another good response is from Healthwatch, [download pdf]

And an excellent response  by Prof John C. McLachlan [download pdf].

Now I’ll filll in some of the background and outline why I think the MHRA still hasn’t understood.

The Medicines Act 1968 and PLRs

The Medicines Act (1968) was passed in the wake of the thalidomide disaster. It required evidence that medicines work and that they are safe. It was not possible to check all existing medicines by the time the Act was implemented in 1971, so, as a temporary measure, many medicines, including homeopathic stuff, were give a "public licence of right" (PLR). Forty years later they have mostly vanished. But not for homeopathy. The PLR is the licence that allows homeopaths to break all the rules. They still exist.

MHRA cocked it up in 2006

The story starts with the National Regulation Scheme for homeopathic junk that was introduced by the MHRA in 2006. This allowed, for the first time, indications to be put on the labels of the bottles of sugar pills. There were howls of outrage from just about every scientific organisation (the medical establishment was, as usual, more pusillanimous, with some honourable exceptions). The history is related here in the following posts.

The MHRA breaks its founding principle: it is an intellectual disgrace 

The Royal Society speaks out on CAM

Learned Societies speak out against CAM, and the MHRA

The MHRA loses the plot: it allows mislabelling of Arnica gel

House of Lords slams homeopathy and the MHRA

MHRA admits herbal medicines unproven

The Science and Technology Select Committee report

This was an admirable effort, It extracted, with some difficulty, admissions from Boots’ professional standards director that the sold pills while knowing that they didn’t work. It also squeezed out of the then Health Minister, Mike O’Brien an admission that they don’t work, Less surprisingly, the head of the MHRA agreed that they don’t work. So it is unanimous (apart, of course, from those who make money from selling things that don’t work).

If you want to know more about Boots’ Professional standards, take a look at Mis-education at Boots the Chemist, or The Vitamin B scam. Don’t trust Boots, or Boots reaches new level of dishonesty with CoQ10 promotion, to name but a few. The oral sessions of the committee were notable for the squirming evasiveness of most of the answers to simple questions. An account can be found in Comedy gold in parliament and tragedy from Prince of Wales: editorial in British Medical Journal

The Government’s response to the report was mostly as truly pathetic bit of official waffle, like those letters you get when you write to your Member of Parliament. But it did contain one good thing."In order for the public to make informed choices, it is therefore vitally important that the scientific evidence base for homeopathy is clearly explained and available." (though even that statement is attributed to John Beddington, the Government’s Chief Scientific advisor, rather than something the Government thinks essential).

"“The MHRA will review the labelling requirements under the NRS to ensure that these deliver clarity as to the status of products and their composition."

The proposals in the MHRA Consultation document’

There are a couple of good things in the proposals. The MHRA proposes to end PLRs (decades overdue, but nonetheless welcome).

The MHRA proposes to stop ‘regulating’ (ho ho) “Bach Flower Remedies” as medicines (but seems happy to classify them as food Supplements, another weasel description to evade sensible regulation). That’s sensible because they aren’t medicines. Homeopathic pills most certainly aren’t medicines either but the MHRA seems to have difficulty grasping that, and wants to treat them quite differently from “Flower remedies”

More honest labelling was about the only sensible thing recommended by the Government’s response. On this topic the MHRA proposals verge on the laughable

At present the labelling allowed under the NRS includes

“A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of ….”

It is proposed to change this to

“A homeopathic medicinal product licensed only on the basis of safety, quality and use within the homeopathic tradition”

“A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of……”

Spot the difference!

The is utterly inadequate. In fact it verges on the pathetic (and on the dishonest). Here is an extract from my full response.

"Sad to say these proposals to remedy the labelling problem are wholly inadequate. They are almost as deceptive as the originals. These labels don‘t come anywhere near to fulfilling the requirement in the government‘s response which said

In order for the public to make informed choices, it is therefore vitally important that the scientific evidence base for homeopathy is clearly explained and available

Why, oh why, cannot the MHRA bring itself to simply tell the truth? It seems to be so stifled by some perversion of political correctness that it is unable to do what it must know is right.

Nothing indicates more clearly the ludicrous state of the NRS than the label approved for Arnica 30C pills.

The approved label says

"ACTIVE INGREDIENT
Each pill contains 30C Arnica Montana
Also contains: lactose and sucrose"

The MHRA must decide whether or not it believes Avogadro‘s number or not.

How many people in the general public realise the ―Each pill contains 30C Arnica Montana‖ means that the ―pills contain no Arnica whatsoever‖? The very mention of the words ―active ingredient‖ will suggest to most people that there is an active ingredient when there is not. This wording alone is both dishonest and deceptive.

The rest of the approved label consists largely of make-believe too.

"If you are pregnant or breastfeeding consult your doctor before use"

What is your doctor meant to advise you about the dangers of taking a few mg of sugar when you are pregnant?

"If you take too much of the product (overdose) speak to a doctor / pharmacist and take this label with you,."

Unless the MHRA has disavowed Avogadro‘s number, an overdose is impossible. To allow a label like this makes the MHRA a laughing stock

https://www.dcscience.net/wp-admin/edit-tags.php?taxonomy=category

Labels should tell the truth in plain language. For example they should say

This product contains no Arnica

There is no evidence that it works for any condition, other than as a placebo

Some comments on regulation of magic medicine

Governments like to regulate things. They should have regulated the banks a bit more. The problem arises when you try to regulate things that are myths. Like homeopathy.

Andy Lewis has recently written a superb account of the problems on his Quackometer blog, When the Regulator Believes in Fairies, Who Protects the Public?

The government appears to believe that "training" will solve all the problems. Training people to believe things that aren’t true can never solve problems. On the contrary, it creates problems. Organisations like the Complementary and Natural Health Care Council (CNHC)do nothing to protect the public, They endanger the public (see Why the CNHC can’t succeed). Their excuse for rejecting complaints that members were making false claims was not to deny that the claims were false, but to say that it didn’t matter because that is what they had been trained to say. That is make-believe regulation.

Follow-up

.This is Andy Lewis’s version of an honest label. It looks quite accurate to me.

quackometer

27 January 2011

News today makes one despair of the morality of governments. Remember those obviously fraudulent bomb detectors, no more than a dowsing rod? Although they are now the subject of a fraud investigation, they are still being sold. The government has banned their export to Iraq and Afghanistan, but NOT to anywhere else, This suggests not only that the government is (or at least was) quite happy to believe in dowsing. It also implies that even when they realise that it’s fraud they take the view that that business is far more important than even the most basic morality. No doubt they will allow fraudulent labelling of medicines in order to protect the homeopathic industry

Does politics have to be quite so disgusting?

28 January 2011. An excellent post on a similar topic is that referred to in a comment below. The MHRA and the non-regulation of homeopathy explains the European background better that I have done.

11 February 2011. Here is a characteristically beautiful response to the consultation by Prof John C. McLachlan, who has allowed me to post it here [download pdf].

Jump to follow-up

Having recently been fired from Ofquack, the Complementary and Natural Healthcare Council (CNHC). I found I was missing the constant dribble of double-speak, Then, as luck would have it, a friend emailed me to draw my attention to a lucrative job at Ninewells Hospital, Dundee.  On August 11th I put out a tweet, just in case any of my friends were interested.

How to save money. NHS Scorland (Tayside) advertises for homeopathic doctor http://bit.ly/9Ou9Yo Pathetic #fail

After the story appeared in the Daily Express it occurred to me that I should apply. It seems that NHS Scotland
Tayside) is determined to look idiotic in the eyes of the world.  They advertised for a homeopathic doctor,  The upper level of salary, £68,000 for two sessions a week, is a great deal more than I ever got paid as holder of the established chair of pharmacology at UCL,  Then I discovered that a crystallographer, David Briggs (@xtaldave on twitter) had applied for the job. If he can, why not I?   I found it hard to match the wit of his supporting statement, but just in case others want to apply, here’s my attempt. The more the merrier.
.

As a Fellow of the Royal Society for the last 25 years, and author of a textbook on statistics, I feel sure that I am capable of dealing with the intellectual rigours of handing out placebos to patients. I feel that my academic qualifications, and my authorship of many research papers, including several articles about homeopathy, should more than make up for my lack of formal qualifications in medicine or homeopathy. Indeed I have spent more time than I care to remember on reading the extensive literature on homeopathy.

Having some expertise in the statistical analysis of clinical trials, my reading of the literature has equipped me well to impress gullible patients with sciencey sounding words like “succussion”, “energy medicine” and “quantum theory”. As an additional qualification, I have read widely about crystal healing, magnetic bracelets, aura photography and other such fairground paraphernalia which are designed, like homeopathy, to impress those with no knowledge of science or medicine.

I have had over two years’ experience of serving on the Conduct and Competence Committee of the Complementary and Natural Healthcare Council, which has provided me with valuable insights into the world of alternative medicine. Indeed I have been told that my name is well known in Clarence House itself.

If appointed to this job, I should like to combine it with research in homeopathy. I would approach this by using systems biology, in the hope that proteomics and metabolomics would be able to explain the still mysterious ability of medicines that contain no medicine to satisfy patients. People whom I know at the University of Westminster have proposed to use systems biology to explain Traditional Chinese Medicine, and I imagine that its application to homeopathy will be every bit as successful as theirs. To have cutting edge research of this sort will, I believe, give NHS Scotland a reputation that will spread around the world.

I would also propose to save the Tayside PCT a lot of money, something not to be ignored in these hard times. At present, homeopathic pharmacies stock many thousands of sorts of pill. Recognising that the majority of them contain nothing at all, I’d retain the labels but fill all the bottles with sugar pills. This would save huge amounts of time and money, while having no effect at all on the outcome for patients.

Despite my lack of formal qualifications, I hope you will agree that I’m qualified intellectually to meet the rigours of your job.

 

Follow-up

I was not the only person to follow the example of David Briggs (@xtaldave). So far I’ve seen Dean Burnett (@garboy) on Science Digestive, Peter Harrison on Reality is My Religion, and Torgwen.

Three days on, there are at least eleven applications, and the three earliest ones have been read something like 12.000 times.

18 August 2010.  Astonished to receive by snail-mail a straight-faced acknowledgment of my application from NHS Tayside [download pdf]. They ask me to send four copies of my CV and fill in forms for Equal Opportunities and Fitness to Practise.  Does this mean I’ve been short-listed?  This gets more surreal by the minute.

Jump to follow-up

Yesterday I was fired from the Conduct and Competence Committee of the CNHC. That is the organisation that was very quickly dubbed Ofquack in the blogosphere.  So now I am free to write what I like about about it.

cnhc logo

It has now become clear that voluntary self-regulation can not work. Recent events at the CNHC show how it has become a victim of its own rules [skip the background].

Background | Complaints | Why CNHC won’t work |

Background

The CNHC was the product of the late unlamented Prince of Wales’ Foundation for Integrated Health. The Prince’s Foundation was paid a large amount of taxpayers’ money, £900,000, by the Department of Health to come up with a scheme for voluntary self-regulation of various sorts of alternative medicine.

There is, as usual, an enormous amount of relevant information can be found on the ebm-first site.

I posted a bit about Ofquack just before I joined them.  There were two main points. One was to draw attention to the wonderful account of CNHC by Polly Toynbee, "Quackery and superstition – available soon on the NHS",   The other was to point out an obvious problem with the job they were supposed to do.

“What won’t work is to insist that homeopaths are “properly trained”. If one takes the view that medicines that contain no medicine can’t work, then years of being trained to say that they do work, and years spent memorizing the early 19th century mumbo-jumbo of homeopathy, does not protect the public, it imperils them.”

On 25 September 2008, someone sent me an advertisement for a job on the conduct and competence committee. The job description seemed to fit me quite well, so I applied. I presumed they wouldn’t take me, and then I could write a blog about it. But after a phone interview with co-chair Maggy Wallace, I was amazed to be offered the job.

Since joining them I haven’t actually done anything whatsoever, apart from offering a few general ideas, because no cases have actually reached the Conduct and Competence Committee.

This was the first time I had encountered a quango at first hand. Several of the members seemed to have no great interest in medicine, or even in alternative medicine. They were more interested in regulation per se, or at least the sort of pseudo-regulation that most of these bodies mostly seem to offer. They seem to suffer from the well-known delusion that you can manage/regulate something without knowing anything about it.  In cases such as this one, where what is being regulated is largely nonsense, there are bound to be problems.

There were two people, whom I did come to like particularly, Maggy Wallace and John Lant. They were both willing to talk and to listen.

The anonymous emails

The alternative medicine community took a surprisingly long time to notice my presence, but on 19 May 2010 a pretty vicious anonymous email arrived at the CNHC, complaining about me.  Here it is.

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Thread-Topic: CNHC and Colquhoun

From: “Sara McGlouglan” <colquhounalertcnhc@gmail.com>


Colquhoun and the CNHC

(Complementary and Natural Health Care Council)

What is the CNHC and why does it exist?

REFLEXOLOGY IS BOLLOCKS!

Nutritional therapy self-styled ‘nutritionists’; making untrue claims about diet in order to sell you unnecessary supplements.

Reiki: tea and sympathy, accompanied by arm-waving.

Shiatsu uh? It seems the teacher is already committed to placebo medicine.

[All the above quotes; and many more stated by David Colquhoun, CNHC Panel member]

Contents

1: Colquhoun and CNHC

2: More statements from Colquhoun

3: Want some more!!!

4: What to do

1. Colquhoun and CNHC

Colquhoun is a man who has steadfastly attacked, denigrated and taken all steps he can to undermine those involved in natural health. Yet Colquhoun is now (and has been for more than a year) a member of the CNHC’s Conduct and Competence Committee.

The role of CNHC is to regulate the professions of their members. But what is the rational behind allowing an avowed critic of natural medicine onto the Conduct and Competence Committee. Isn’t this like asking racist to be objective about the circumstances of racist crime?

Would you, as a practitioner having to answer to a complaint, be happy to have one of the panel members think your profession is ‘bollocks’ or that everything you practice is fraudulent from the start?

Latest moves from the government now aim at putting all Herbal Practitioners under the authority of CNHC.

Do you want your personal and confidential data, and that of your patient/client in the hands of Colquhoun? What might happen to it?

Certainly every practitioner has to be responsible for their actions and practice but since when has it been standard practice to weigh the scales against you rather than be assessed by a panel of independent peers?

2. More statements by Colquhoun ‘ nonsense, untrue, unnecessary, rectal obsession, mystic barmpot, fraud, theatrical placebo

In his "Patients’ guide to Magic medicine” [https://www.dcscience.net/?page_id=733]

Colquhoun summarizes many of the CNHC members’ professional activities (and other professions too) as follows:

* Reflexology: plain old foot massage, overlaid with utter nonsense about non-existent connections between your feet and your thyroid gland.

* Nutritional therapy: self-styled ‘nutritionists’ making untrue claims about diet in order to sell you unnecessary supplements.

* Spiritual healing: tea and sympathy, accompanied by arm-waving.

* Reiki: ditto.

* Angelic Reiki. The same but with added Angels, Ascended Masters and Galactic Healers. Excellent for advanced fantasists.

* Colonic irrigation: a rectal obsession that fails to rid you of toxins which you didn’t have in the first place.

* Anthroposophical medicine: followers of the mystic barmpot, Rudolf Steiner, for whom nothing whatsoever seems to strain credulity

* Alternative diagnosis: kinesiology, iridology, vega test etc, various forms of fraud, designed to sell you cures that don’t work; for problems you haven’t got.

* Homeopathy: giving patients medicines that contain no medicine whatsoever.

* Herbal medicine: giving patients an unknown dose of an ill-defined drug, of unknown effectiveness and unknown safety.

* Acupuncture: a rather theatrical placebo, with no real therapeutic benefit in most if not all cases.

So what kind of organisation is CNHC and why have they put him on to their Conduct and Competence panel? Being a CNHC member seems to be like inflicting pain on yourself.

CNHC also received funding from the Prince’s Foundation for Integrated Health (FIH). Yet Colquhoun regularly lambasts the FIH and Prince Charles himself categorizing him as a ‘champion of endarkenment’ [https://www.dcscience.net/?p=2544] and calling the FIH the Foundation Fellows of the Prince of Wales Foundation for Magic Medicine, an organisation that is at the forefront of spreading medical misinformation. [https://www.dcscience.net/?p=2131]

Of course, no one expects that because an organisation provides funding it should be exempt from criticism but surely, if you are working for an organisation whose purpose is to represent standards in a certain field, why would you have someone on your management team who fires out carping criticism at the supporting organisation, its practitioners and its practices unless perhaps, it is your purpose to spread discord and cut the funding.

No wonder the CNHC has problems. Their business plan (contingent on funding) was initially to have more than 10,000 enrolled members. This has been revised down to 2,000 and by all counts they have not even made this. Not surprising if the practitioners whom you represent don’t have any trust in the organisation that is supposed to represent the standards of your profession.

3. Want some more!!! fantasists, wrong and dangerous, largely quackery, lies, mumbo-jumbo, made-up fantasies, placebo medicine

On nutritional therapy

It is interesting to compare the high standards of the Nutrition Society with the quite different standards of BANT (the British Association for Applied Nutrition and Nutritional Therapy).& They bill themselves as the “Professional Body for Nutritional Therapists”. Nutritional therapists are those fantasists who believe you can cure any ill by buying some supplement pills. [https://www.dcscience.net/?p=1391]

[On quotes taken from Nutritional Therapy text] That must be about as close as you can get to claiming you can prevent cancer by taking vitamin pills. It is wrong and t is dangerous,

Sigh. What century are we living in? [https://www.dcscience.net/?p=555]

Everyone is for good nutrition of course, but ‘nutritional medicine’, or ‘nutritional therapy’ pretends to be able to cure all sorts of diseases by changes in diet or by buying expensive nutritional supplement pills. It has no perceptible relationship to the very important subjects of ‘nutrition’ or ‘dietetics’.. ‘Nutritional therapy’ is very firmly part of alternative medicine, in other words it is largely quackery. If you don’t believe that, read on. https://www.dcscience.net/?p=260

On Reflexology

As usual, not many seemed to care very much about the secondary consequences of employing a ‘reflexologist’, namely that some poor kid has to memorise a bunch of lies to get the piece of paper demanded by HR (and the taxpayer has to fund it). https://www.dcscience.net/?page_id=237

What is the evidence about ‘spiritual healing’ ? Very little it seems.

No doubt, mumbo-jumbo can make some people feel better, and to that extent it is justified. But it can and should done be honestly (for example, foot massage is fine, ‘reflexology’ isn’t). Lies to patients should be minimised and universities should not be tempted to hand out certificates in mumbo jumbo. https://www.dcscience.net/?p=34

Michael McIntyre has the first of several long speeches, advocating more research. There was an advertisement for his web site “promotes best practice” (allegedly). He talks quite seriously about “reflexology” and so on, as though it were real subject (it isn’t; its “principles” are made-up fantasies). https://www.dcscience.net/?p=2813

Much of what they do at the Christie is straightforward massage, but they also promote the nonsensical principles of ‘reflexology’ and acupuncture. https://www.dcscience.net/?p=1466

The hilarious Radio 4 programme, The News Quiz had a good joke. Jeremy Hardy was asked which patients are hoping for a more robust constitution?. This referred to the £1m PR exercise mounted by the NHS to launch the NHS constitution. Hardy said that in the week when Barack Obama was inaugurated, and the word constitution have a whole different sort of gravitas in a week like that.

"I think the constitution should open with the words “We hold these truths to be self-evident REFLEXOLOGY IS BOLLOCKS" https://www.dcscience.net/?page_id=237

On Shiatsu

Shiatsu uh? It seems the teacher is already committed to placebo medicine. https://www.dcscience.net/?p=454

4. What to do

Why join an association that condones the above? Many have never joined CNHC because of this and other issues whilst existing CNHC members do not want to remain members.

1. Contact your professional association and insist that they do not join CNHC.

2. If your association is already a member then make a complaint and insist that your personal details are not supplied to CNHC.

3. There are other associations in existence that have the same purpose as CNHC. Find out about them. You (or your professional association) have the option to join them and
be represented by/answerable to them. CNHC is not the only option and one should wonder why they were chosen in the first place.

4. Please pass on this information to anyone else that you know. It is important that we are represented honestly and with integrity. The actions of CNHC do not add up.

ooOOoo

Nobody seems to know the real name of Sara Glougan (aka Sam McGlougan.  The letter is, I suppose, fair enough. I did say most of those things.  What’s objectionable is that the anonymous writer seems to think that my opinions disqualify me from judging dispassionately a Conduct and Competence case.  What this letter really says is that "we don’t want anyone who cares about the truth of claims to have any power over us".  They just don’t want to be regulated in any effective way.  The co-chair, Maggy Wallace, is a bit more sensible than that.  The reason that I was appointed by her was because of my knowledge about how to assess evidence. But that isn’t a topic that interests alternative medicine advocates.

The fact of the matter is that the CNHC has been signing up people at a far slower rate than it hoped originally.  It is in dire financial trouble (see, for example, Will the government bail out Ofquack?>, and CNHC’s report to the Department of Health in June 2009, obtained under the Freedom of Information Act.. The last thing they can afford is anything like this letter, which might reduce the registration rate still further. So it was inevitable that they had to get rid of me. Initially I was invited to resign on grounds of bad health. I didn’t, so on 10 August 2010 I was asked to appear before the board to be fired (in the nicest possible way). The CNHC now has nobody with any statistical expertise. Needless to say I’m not heartbroken about it. It was a waste of time for me, but it did provide a valuable insight into how voluntary self-regulation works, or rather fails to work.

The complaints against reflexologists

[skip the complaints.]

The CNHC has a complaints procedure, though its operation is somewhat tortuous.. As soon as they started to register reflexologists, several complaints were sent by the indefatigable Simon Perry (read his account)

“The ad suggests that reflexology is suitable for treating babies with colic, IBS and arthritis. She also claims to have experience in treating fertility issues. There is no reliable evidence to suggest that reflexology is capable of treating [these] issues.”

This complaint never came to to the Conduct and Competence Committee. It didn’t get past the preliminary Investigating Committee (chaired by John Lant), the job of which is to see if there is a case to answer. They decided that the advertisements in question did indeed breach paragraph 15 of the CNHC’s Code of Conduct, Performance and Ethics (see below). All 14 of Simon Perry’s complaints were upheld. However the Investigating Committee Panel’s report went on to say, apparently on the advice of the ‘Profession specific boards’ that

“The ICP found that the registrants’ Fitness to Practise was not impaired, because they did not deliberately seek to mislead their clients or to exaggerate the benefits of the therapy which they described in good faith. However they found that the registrants had made claims about the therapy offered which appeared to imply more efficacy than evidence necessarily provides.”

That, presumably, is why the complaints never reached the Conduct and Competence Committee. There was no case to answer.

One must admire Maggy Wallace’s statement that she “place on formal record their thanks to Simon Perry for bringing this matter to their attention.”.   Never the less the problem is glaringly obvious and it shouldn’t have need a complaint.

Why ofquack can never work

The complaint episode is fascinating. The CNHC has clearly painted itself into a corner. It has brought to the fore all the contradictions that are inherent in what they are trying to do.

They have decided that reflexologists make false claims about what they can achieve.

But they decided it wasn’t the fault of the reflexologists because that is what they had been taught

Therefore the CNHC has judged that fitness of reflexologists to practise is not affected by the fact that they make false health claims.

That means that the CNHC judges that the public safety is not affected by whether their members make false health claims. That seems ludicrous enough, but it goes further

In the initial publicity it was often said that the job of the CNHC was safety -their job to protect the public, not to judge whether treatments worked or not. That sort of statement is contradicted directly by paragraph 15 of their Code of Conduct, Performance and Ethics, which reads thus.

15. You must follow CNHC guidelines in relation to advertising your services

Any advertising you undertake in relation to your professional activities must be accurate. Advertisements must not be misleading, false, unfair or exaggerated. You must not claim that your personal skills, equipment or facilities are better than anyone else’s.

If you are involved in advertising or promoting any other product or service, you must make sure that you use your knowledge, healthcare skills, qualifications and experience in an accurate and professionally responsible way. You must not make or support unjustifiable statements relating to particular products or services. Any potential financial rewards to you should be made explicit and play no part at all in your advice or recommendations of products and services that you give to patients, clients and users.

This paragraph places on the CNHC the responsibility for judging whether or not a treatment does what’s claimed for it. With my departure, there is really nobody left who is well-qualified to do that,
but nonetheless, their judgement on claims made by reflexologists was quite right.

The assertion by the CNHC that the false claims were OK because that is what reflexologists are taught is a direct admission that the courses that ‘train’ reflexologists are teaching them to say things that are not true. Of course the rest of the world knew that already, but to have it admitted by the CNHC is amazing.

Part of the job of the CNHC is to judge whether registrants are properly trained. But they have just decided that courses for reflexologists teach them to say things that aren’t true, That leaves the CNHC it an impossible position. By accepting reflexologists, they are saying that it doesn’t really matter that they are taught to make false claims, The criteria for entry include

“Have undertaken a programme of education and training which meets, as a minimum, the National Occupational Standards for that profession/discipline”

This shifts the responsibility for deciding what’s acceptable to National Occupational Standards and Skills for Health. Neither of these quangos is in the least concerned about what’s true and what isn’t. That’s not surprising when you realise who drafted all the HR style nonsense to be found at Skills for Health? None other than the late Prince of Wales’ Foundation. The stuff produced by them isn’t worth the paper it’s written on. There is something about Skills for Health in the post where I recount a phone call with them, When I asked whether they would produce standards for talking to trees, I was referred, in all seriousness, to LANTRA, the Land based skills council. You couldn’t make it up.

The National Occupational Standards (NOS) directory leads to the NOS for reflexology.  The preamble says

Reflexology is the study and practice of treating reflex points and areas in the feet and hands that relate to corresponding parts of the body. Using precise hand and finger techniques a reflexologist can improve circulation, induce relaxation and enable homeostasis. These three outcomes can activate the body’s own healing systems to heal and prevent ill health. 

There is, if course, not a shred of reason to think that “areas in the feet and hands that relate to corresponding parts of the body”. This statement alone would fail the CNHC’s code of conduct. National Occupational Standards in this area are simply a farce.

What will the CNHC do about these paradoxes? The complaint report said

“The ICP have asked Maggie Dunn, the CNHC Registrar, to initiate, as a matter of priority, discussions with the CNHC’s Profession Specific Boards and the Professional Fora to agree advice to registrants in relation to paragraph 15.”

I was told that this might take between 3 and 5 years to do. But I have a strong feeling that it will never be done in any effective way. If the CNHC prevented training courses from teaching students to make claims that aren’t justified by evidence, just about every course would close and the CNHC would crumble to dust. The result would be the ultimate irony. Alternative medicine would be abolished, not by skeptics, but by the CNHC.

That follows inevitably from the complaint judgement combined with paragraph 15 of the code of conduct.

It will be fascinating to see how the CNHC tries to escape from the grave that it has dug for itself.

If the CNHC implements properly its own code of conduct, few people will sign up and CNHC will die. If it fails to implement its own code of conduct it would be shown to be a dishonest sham.

Follow-up

Interview for Pod Delusion on the CNHC case