Warning: fopen(/home/dcscience/public_html/wp-content/wflogs/rules.php): failed to open stream: No such file or directory in /home/dcscience/public_html/wp-content/plugins/wordfence/vendor/wordfence/wf-waf/src/lib/waf.php on line 325

Warning: flock() expects parameter 1 to be resource, boolean given in /home/dcscience/public_html/wp-content/plugins/wordfence/vendor/wordfence/wf-waf/src/lib/waf.php on line 326

Warning: include(/home/dcscience/public_html/wp-content/wflogs/rules.php): failed to open stream: No such file or directory in /home/dcscience/public_html/wp-content/plugins/wordfence/vendor/wordfence/wf-waf/src/lib/waf.php on line 328

Warning: include(): Failed opening '/home/dcscience/public_html/wp-content/wflogs/rules.php' for inclusion (include_path='.:/usr/share/php:/usr/share/pear') in /home/dcscience/public_html/wp-content/plugins/wordfence/vendor/wordfence/wf-waf/src/lib/waf.php on line 328

Warning: flock() expects parameter 1 to be resource, boolean given in /home/dcscience/public_html/wp-content/plugins/wordfence/vendor/wordfence/wf-waf/src/lib/waf.php on line 329

Warning: fclose() expects parameter 1 to be resource, boolean given in /home/dcscience/public_html/wp-content/plugins/wordfence/vendor/wordfence/wf-waf/src/lib/waf.php on line 330
Health Professions Council – DC's Improbable Science

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

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

Latest Tweets
Categories
Archives

Health Professions Council

It makes a nice change to be able to compliment an official government report.

Ever since the House of Lords report in 2000, the government has been vacillating about what should be done about herbalists. At the moment both western herbalists and traditional Chinese medicine (TCM) are essentially unregulated. Many (but not all) herbalists have been pushing for statutory regulation, which they see as government endorsement. It would give them a status like the General Medical Council.

A new report has ruled out this possibility, for very good reasons [download local copy].

Back story (abridged!)

My involvement began with the publication in 2008 of a report on the Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine . That led to my post, A very bad report: gamma minus for the vice-chancellor. The report was chaired by the late Professor Michael Pittilo BSc PhD CBiol FIBiol FIBMS FRSH FLS FRSA, Principal and Vice-Chancellor of The Robert Gordon University, Aberdeen. The membership of the group consisted entirely of quacks and the vice -chancellor’s university ran a course in homeopathy (now closed).

The Pittilo report recommended statutory regulation and "The threshold entry route to the register will normally be through a Bachelor degree with Honours". It ignored entirely the little problem that you can’t run a BSc degree in a subject that’s almost entirely devoid of evidence. It said, for example that acupuncturists must understand " yin/yang, 5 elements/phases, eight principles, cyclical rhythms, qi ,blood and body fluids". But of course there is nothing to "understand"! They are all pre-scientific myths. This “training dilemma” was pointed out in one of my earliest posts, You’d think it was obvious, but nonetheless the then Labour government seemed to take this absurd report seriously.

In 2009 a consultation was held on the Pittilo report. I and many of my friends spent a lot of time pointing out the obvious. Eventually the problem was again kicked into the long grass.

The THR scheme

Meanwhile European regulations caused the creation of the Traditional Herbal Registration (THR) scheme. It’s run by the Medicines and Healthcare products Regulatory Authority (MHRA). This makes it legal to put totally misleading claims on labels of herbal concoctions, as long as they are registered with THR, They also get an impressive-looking certification mark. All that’s needed to get THR registration is that the ‘medicines’ are not obviously toxic and they have been in use for 30 years. There is no need to supply any information whatsoever about whether they work or not. This appears to contradict directly the MHRA’s brief:

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

After much effort, I elicited an admission from the MHRA that there was no reason to think that any herbal concoctions were effective, and that there was nothing to prevent them from adding a statement to say so on the label. They just chose not to do so. That’s totally irresponsible in my opinion. See Why does the MHRA refuse to label herbal products honestly? Kent Woods and Richard Woodfield tell me. Over 300 herbal products have been registered under the THR scheme (a small percentage of the number of products being used). So far only one product of Tibetan medicine and one traditional Chinese medicine have been registered under THR. These are the only ones that can be sold legally now, because no herbs whatsoever have achieved full marketing authorisation -that requires good evidence of efficacy and that doesn’t exist for any herb.

The current report

Eventually, in early 2014, the Tory-led government set up yet another body, "Herbal Medicines and Practitioners Working Group " (HMPWG). My heart sank when I saw its membership (Annex A.2). The vice-chair was none other that the notorious David Tredinnick MP (Con, Bosworth). It was stuffed with people who had vested interests. I wrote to the chair and to the few members with scientific credentials to put my views to them.

But my fears were unfounded, because the report of the HMPWG was not written by the group, but by its chair only. David Walker is deputy chief medical officer and he had clearly listened. Here are some quotations.

The good thing about the European laws is that

"This legislation effectively banned the importation and sale of large-scale manufactured herbal medicine products. This step severely limited the scope of some herbal practitioners to continue practising, particularly those from the Traditional Chinese Medicine (TCM) and Ayurvedic traditions."

The biggest loophole is that

"At present under UK law it is permitted for a herbal practitioner to see individual patients, offer diagnoses and prepare herbal treatments on their own premises, as long as these preparations do not contain banned or restricted substances. This is unchanged by the Traditional Herbal Medicinal Products Directive. "

Walker recognised frankly that there is essentially no good evidence that any herb, western or Chinese, works well enough to make an acceptable treatment. And importantly he, unlike Pittilo, realised that this precludes statutory regulation.

"There are a small number of studies indicating benefit from herbal medicine in a limited range of conditions but the majority of herbal medicine practice is not supported by good quality evidence. A great deal of international, primary research is of poor quality. "

"ts. Herbal medicine practice is therefore currently based upon traditional practice rather than science. It is difficult to differentiate good practice from poor practice on the basis of this evidence in a way that could establish standards for statutory regulation"

The second problem was the harms done by herbs. Herbalists, western and Chinese, have no satisfactory way of reporting side effects

" . .   . there is very limited understanding of the risks to patient safety from herbal medicines and herbal practice. A review of safety data was commissioned from HMAC as part of this review. This review identified many anecdotal reports and case studies but little systematically collected data. Most herbal medicine products have not been through the rigorous licensing process that is required of conventional pharmaceutical products to establish their safety and efficacy. Indeed, only a small proportion have even been subject to the less rigorous Traditional Herbal Registration (THR) process. "

"The anecdotal evidence of risk to patients from herbal products in the safety review highlighted the prominence of manufactured herbal medicines in the high profile serious incidents which have been reported in recent years. Many of these reports relate to harm thought to be caused by industrially manufactured herbal products which contained either dangerous herbs, the wrong constituents, toxic contaminants or adulterants. All such industrially manufactured products are now only available under European regulations if their safety is assured through MHRA licensing or THR
accreditation; and specific dangerous herbs have been banned under UK law. This has weakened the case for introduction of statutory regulation as a further safety measure. "

Then Walker identified correctly the training dilemma. Although it seems obvious, this is a big advance for a government document. Degrees that teach nonsense are not good training: they are miseducation.

"The third issue is the identification of educational standards for training practitioners and the benchmarking of standards for accrediting practitioners. With no good data on efficacy or safety, it is difficult for practitioners and patients to understand or quantify the potential benefits and risks of a proposed therapeutic intervention. Training programmes could accredit knowledge and skills in some areas including pharmacology and physiology, professional ethics and infection control but without a credible evidence base relating to the safety and effectiveness of herbal medicine it is hard to see how they could form the basis of accreditation in this field of practice.

There are a number of educational university programmes offering courses in herbal medicine although the number has declined in recent years. Some of these courses are accredited by practitioner organisations which is a potential governance risk as the accreditation may be based on benchmarks established by tradition and custom rather than science.
"

"The herbal medicine sector is in a dilemma" is Walker’s conclusion.

"Some practitioners would like to continue to practise as
they do now, with no further regulation, and accept that their practice is based on tradition and personal experience rather than empirical science. The logical consequence of adopting this form of practice is that we should take a precautionary approach in order to ensure public safety. The public should be protected through consumer legislation to prevent false claims, restricting the use of herbal products which are known to be hazardous to health"

The problem with this is, if course, is that although there is plenty of law, it’s rarely enforced : see Most alternative medicine is illegal Trading Standards very rarely enforce the Consumer Protection Regulations (2008) but Walker is too diplomatic to mention that fact.

"The herbals sector must recognise that its overall approach (including the rationale for use of products and methods of treatment, education and training, and interaction with the NHS) needs to be more science and evidence based if in order to be established as a profession on the same basis as other groups that are statutorily regulated."

So what happens next?

In the short term nothing will happen.

The main mistake has been avoided: there wil be no statutory regulation.

The other options are (a) do nothing, or (b) go for accreditation of a voluntary register (AR) by the Professional Standards Authority for Health and Social Care (PSA). Walker ends up recommending the latter, but only after a lot more work (see pages 28-29 of report). Of particular interest is recommendation 5.

"As a first step it would be helpful for the sector organisations to develop an umbrella voluntary register that could support the development of standards and begin to collaborate on the collection of safety data and the establishment of an academic infrastructure to develop training and research. This voluntary register could in due course seek accreditation from the Professional Standards Authority for Health and Social Care (PSA)."

So it looks as though nothing will happen for a long time, and herbalists and TCM may end up with the utterly ineffectual PSA. After all, the PSA have accredited voluntary registers of homeopaths, so clearly nothing is too delusional for them. It’s very obvious that, unlike Walker, the PSA are quite happy to ignore the training dilemma.

Omissions from the report

Good though this report is, by Department of Health standards, it omits some important points.

Endangered species and animal cruelty aren’t mentioned in the report. Traditional Chinese medicine, and its variants, are responsible for the near-extinction of rhinoceros, tiger and other species because of the superstitious belief that they have medicinal value. It’s not uncommon to find animal parts in Chinese medicines sold in the UK despite it being illegal

And the unspeakably cruel practice of farming bears to collect bile is a direct consequence of TCM.

bile bear
A bile bear in a “crush cage” on Huizhou Farm, China (Wikipedia)

 

Statutory regulation of Chiropractors

The same arguments used in Walker’s report to deny statutory regulation of herbalism, would undoubtedly lead to denial of statutory regulation of chiropractors. The General Chiropractic Council was established in 1994, and has a status that’s the same as the General Medical Council. That was a bad mistake. The GCC has not protected the public, in fact it has acted as an advertising agency for chiropractic quackery.

Perhaps Prof. Walker should be asked to review the matter.

Follow-up

You can also read minutes of the HMPWG meetings (and here). But, as usual, all the interesting controversies have been sanitised.

Edzard Ernst has also commented on this topic: Once again: the regulation of nonsense will generate nonsense – the case of UK herbalists.

It’s hard to know what to make of  David Tredinnick MP (Cons, Bosworth). He is certainly an extreme example of the scientific ignorance of our parliamentary representatives, but he isn’t alone in that. Our present minister of Education, Michael Gove, memorably referred to Newton’s Laws of Thermodynamics, blissfully unaware that thermodynamics was a 19th century development. And our present Minister of Health seems to think that magic water cures diseases.

But Mr Treddinick breaks every record for anti-scientific nonsense. That, no doubt, is why he was upset by the recent revision of come NHS Choices web pages, so that they now give a good account of the evidence (that’s their job, of course). They did that despite two years of obstruction by the Department of Health. which seemed to think that it was appropriate to take advice from Michael Dixon of the Prince’s Foundation for integrated Health. That shocking example of policy based evidence was revealed on this blog, and caused something of a stir.

Treddinick’s latest letter

A copy of a letter from Mr Tredinnick to the Minister of Health, Jeremy Hunt, has some into my possession by a tortuous route [download the letter]. It’s a corker. Here are a few quotations.

"1. UKIP moving onto our ground
Attached is an extract from a recent UKIP policy statement. The position which UKIP has taken is one with which most of our Daily Mail reading supporters of complementary medicine would agree."

It seems that Treddinick’s preferred authority on medicine is now Nigel Farage, leader of the UK’s far right party. UKIP’s policy on health is appended to the letter, and it’s as barmy as most of the other things they say.

"2. Herbal Medicine
. . .there is very real concern that the Government will not regulate Herbal Medicine and Traditional Chinese Medicine. The current situation is unacceptable, because herbal practitioners need regulation and cannot function as herbal therapists, nor can they cannot obtain stocks of their herbal remedies, without it.

This refers to a saga that has been running for at least 10 years. Herbalists are desperate to get a government stamp of approval by getting statutory regulation, much like real doctors have, despite the fact that they make money by selling sick people "an unknown dose of an ill-defined drug, of unknown effectiveness and unknown safety" (as quoted recently in the House of Lords).

Even  the US National Center for Complementary and Alternative Medicine (NCCAM) doesn’t claim that a single herbal treatment is useful. The saga of herbal regulation is long and tedious. The short version is that a very bad report, The Pittilo report, recommended regulation of herbalists. After years of prevarication, Andrew Lansley ignored the impartial scientific advice and yielded to the pressure from the herbal industry to accept the Pittilo report. But still nothing has happened.

Could it be that even Jeremy Hunt realises, deep down, that the regulation of nonsense is a nonsense that would harm the public?

We can only hope that a letter from Mr Tredinnick is the kiss of death. Perhaps his continuous pestering will only reinforce the doubts that seem to exist at the Department of Health.

Then Tredinnick returns (yawn) to his obsession with magic water. He vents his rage at the now excellent NHS Choices page on homeopathy.

3. Homeopathy

"Recently this wording has been removed and instead a comment by the Chief Medical Officer that homeopathy is placebo inserted in its place, as well as links to external organisations which campaign against homeopathy. For instance, there is a link to the Sense About Science website, and Caroline Finucane, who is Editor of new content at NHS Choices, also writes for the Sense About Science website. This is an organisation which has no expertise in homeopathy and traces its roots back to the ultra-left Revolutionary Communist Party (RCP)."

"I respectfully suggest that the original wording be reinstated and these links to external organisations be removed or changed to ensure a balanced view.".

So it seems that he prefers the medical views of Nigel Farage and the Prince of Wales to those of the Chief Medical Officer and the government’s chief scientist. Disgracefully, Tredinnick picks out one particular employee of NHS Choices among many, and one who does an excellent job. And he raises the hoary old myth that Sense About Science is a communist organisation. Odd, since others accuse it of being neo-libertarian. The actual history is here. The organisation that is a bit too libertarian for my taste is Spiked Online. I haven’t agreed with every word that Sense about Science has printed, but they have a totally honest belief in evidence.

To drag in the name of one person out of many, and to justify it by a false history shows, once again, how very venomous and vindictive the advocates of delusional medicine can be when they feel cornered.

A bit more information about Mr Treddinick

This is what the BBC News profile says about him.

David Tredinnick is an old style Conservative MP, being an Eton-educated former Guards officer, who has sat in the Commons since 1987.

However, his ambition for high office was thwarted by his role in one of the sleaze stories which helped to sink the Major government. He accepted £1,000 from an undercover reporter to ask parliamentary questions about a fictitious drug. He was obliged to resign from his role as a PPS and was suspended from the Commons for 20 sitting days. He has not sat on the frontbench since.

He is an orthodox Conservative loyalist, though he is more supportive of the European Union than many of his colleagues.

He has, however, carved himself a niche as the Commons’ most enthusiastic supporter of complementary medicine. He has wearied successive health secretaries with his persistent advocacy of any and all homeopathic remedies. He has also supported their use in prisons and even suggested them as an aid in alleviating the foot and mouth crisis.

Tredinnick has also asserted that he was aware of a psychiatric hospital that doubled its staff at full moon (this is an old urban myth, and is, of course, quite untrue).

His advocacy of homeopathic borax as a way to control the 2001 epidemic of foot and mouth diease can be read here. Luckily it was ignored by the government. I hope his latest letter will be treated similarly.

Picture of David Tredinnick MP from the Conservative Party

tredinnick

Follow-up

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.”

Jump to follow-up

The long-awaited government decision concerning statutory regulation of herbalists, traditional Chinese medicine (TCM) and acupuncture came out today.

Get the Department of Health (DH) report [pdf]

It is not good news. They have opted for statutory regulation by the Health Professions Council (HPC). This is much what was recommended by the disgraceful Pittilo report, about which I wrote a commentary in the Times (or free version here), and A very bad report: gamma minus for the vice-chancellor.

The DH report is merely an analysis of responses to the consultation, but the MHRA says

"The Health Professions Council (HPC) has now been asked to establish a statutory register for practitioners supplying unlicensed herbal medicines. The proposal is, following creation of this register, to make use of a derogation in European medicines legislation (Article 5 (1) of Directive 2001/83/EC) that allows national arrangements to permit those designated as “authorised healthcare professionals” to commission unlicensed medicines to meet the special needs of their patients."

The MHRA points out that this started 11 years ago with the publication of the  House of Lords report (2000). Both that report, and the government’s response to it, set the following priorities. Both state clearly

“… we recommend that three important questions should be addressed in the following order . .

  • (1) does the treatment offer therapeutic benefits greater than placebo?
  • (2) is the treatment safe?
  • (3) how does it compare, in medical outcome and cost-effectiveness, with other forms of treatment?

The report of DH and the MHRA’s response have ignored totally two of these three requirements. There is no consideration whatsoever of whether treatments work better than placebo (point one) and there is no consideration whatsoever of cost-effectiveness (point 3). These two important recommendations in the Houss of Lords report have simply been brushed under the carpet.

Needless to say, herbalists are head over heels with joy at this sign of official endorsement (here is one reaction)

Here are my first reactions. The post will be updated soon.

The DH report is, in a sense, democratic. They have simply counted the responses, for and against each proposal. They seem to be quite unaware that most of the responses come from High Street herbailsts whose main aim is to gain respectability. The response of the Academy of Royal Medical Colleges counts as one vote, just the same as the owner of a Chinese medicine shop. This is not how health policy should be determined. Some intervention of the brain is needed, but that isn’t apparent in the report.

At present the HPC regulates Arts therapists, biomedical scientists, chiropodists/podiatrists, clinical scientists, dietitians, occupational therapists, operating department practitioners, orthoptists, paramedics, physiotherapists, prosthetists/orthotists, radiographers and speech & language therapists. I shudder to think what all these good people will think about being lumped together with people who practice evidence-free medicine (or, worse, forms of medicine where there is good evidence that they don’t work).

The vast majority of herbalists, traditional Chinese medicine (TCM) and acupuncture has no good evidence that it works, In the case of soem herbal medicines and acupuncture, there is good evidence that they don’t work. Yet the HPC has, as one of its criteria, that aspiring to be regulated by them requires

"practise based on evidence of efficacy"

The Department of Health seems to have quietly forgotten about this criterion. It cannot possibly be met. The HPC has already expressed its willingness to go along with this two-faced approach (see Health Professions Council ignores its own rules: the result is nonsense )

Another mistake made by the Department of Health regards the value of "training". The report (page 11) says

Would statutory regulation lessen the risk of harm? (Q2)
Again, the vast majority of respondents thought it would. Reasons given were that statutory regulation would ensure that herbal practitioners and acupuncturists are carefully and thoroughly trained. That training is subject to accreditation, evaluation and periodic review by independent educational and training professionals, and disciplinary oversight by a regulating body. Incompetent or unscrupulous practitioners could be struck off the register and prevented from practising.

Although it is pointed out to them in several responses, the Department of Health seems quite incapable of understanding a simple and obvious truth. Spending three years training people to learn things that are not true, safeguards nobody. On the contrary, it endangers the public. Training in nonsense is obviously a nonsense.

At the end of the report is a list of organisations who responded, As expected, they are predominantly trade bodies that have a vested interest in allowing thinks to be sold freely regardless of whether they work or not. The first four are Alliance of Herbal Medicine Practitioners. European herbal and Traditional Medicine Practitioners Association (ETMPA), Association Chinese Medicine Practitioners (UK) (ACMP) and Acupuncture Society. And so on.

More coming soon.

Follow-up

16 February 2011. Later the same day, we see one reason why Michael Mcintyre, chair of the European Herbal Practitioners Association, got what he wanted to promote his trade. They had evidently hired a PR Agency, Cogitamus, to push their case. Now they are crowing about their victory. And of course his profits were not harmed by the free publicity that was given to his cause by the BBC,

The pinheads in the Department of Health are more easily persuaded by a PR agency than by any number of people who know a lot more about it, and who have no profit motive.

17 February 2011.

The herbal problem was front page news in the London free paper, the Metro: Chinese medicine and herbal ban to see Britain defy EU laws

The Daily Telegraph covered the story: Herbal medicine to be regulated, says Andrew Lansley. The comments featured some pretty mad rants from herbalists, to which I tried to reply.

The Metro article elicited a fine bit of abuse from a Lynda Kane. I’m constantly amazed at the downright viciousness of cuddly holistic therapists when they get found out. I guess it is just another bad case of cognitive dissonance. I can’t resist a few quotations.

Sir,

“I have just come across your asinine comments quoted in the London Metro newspaper re the EU herbal medicine directive. For a supposed scientist your mis-informed, closed-minded, unsubstantiated bigotry leaves me speechless”

“As a scientist myself, I abide by the virtues of open-minded neutrality and accepting the hypothesis until proven otherwise by null-hypothesis based research.”

“How many of the innumerable studies on the efficacy of herbal medicine have you read? “

“Perhaps in your ‘day’ professors could say whatever they liked and be listened to. That day is long gone, as you must know from the various law-suits you have been party to.”

I love the idea that statistics allow you to accept any hypothesis whatsoever until someone shows it to be wrong.

This would be funny if it were not so sad (and rather painful). As always I replied politely and referred her to NCCAM’s Guide to Herbs, so she can check up on that plethora of evidence that she seems to think exists.

This is Lynda Kane of energyawareness.org. I can recommend her web site, if you want some truly jaw-dropping woo. She’ll sell you a “White Jade Energy Egg – may provide up to 5 times as much protection from wifi and from other peoples’ energies – costs £47.00”. Hmm, sounds good. How does it work? Easy.

“The human energy or “qi” field is shaped like an egg. It is being attacked by many forms of natural and man-made environmental stress 24 hours a day.”

I guess that’s OK according to Ms Kane’s interpretation of statistics which allows you to accept any hypothesis whatsoever until someone shows it to be wrong.

Anyone for Trading Standards or the ASA?

17 February 2011. The excellent Andy Lewis has posted on similar problems “How to Spot Bad Regulation of Alternative Medicine

.20 July 2013

Nothing visible happened after this announcement. Until the government’s resident medical loon, David Tredinnick MP forced a debate on the matter. His introduction to the debate was his usual make-believe. Sadly it made much of an exhibit at the Royal Society Summer Science exhibition -a bit of bait and swich by aromatherapists.

After ploughing your way through pages of nonsense, you get to the interesting bit. At 10.38 am, The Parliamentary Under-Secretary of State for Health, Dr Daniel Poulter, announced what was happening. It seems that there may, after all, have been some effect of all the sensible submissions which pointed out the impossibility of regulating nonsense. The question of regulation has, yet again, been postponed.

"To ensure that we take forward the matter effectively, we want to bring together experts and interested parties from all sides of the debate to form a working group that will gather evidence and consider all the viable options in more detail," 

One wonders who will be on this working group? If they don’t choose the right people, it could be as bad as the Pittilo report. It wasn’t reassuring to read

" we want to set up a working group and to work with my hon. Friend [Tredinnick], and herbalists and others, to ensure that the legislation is fit for purpose."

Two weeks left to stop the Department of Health making a fool of itself. Email your response to tne Pittilo consultation to this email address HRDListening@dh.gsi.gov.uk

I’ve had permission to post a submission that has been sent to the Pittilo consultation. The whole document can be downloaded here. I have removed the name of the author. It is written by the person who has made some excellent contributions to this blog under the pseudonym "Allo V Psycho".

The document is a model of clarity, and it ends with constructive suggestions for forms of regulation that will, unlike the Pittilo proposals, really protect patients

Here is the summary. The full document explains each point in detail.

Executive Summary
Statutory regulation lends prestige, but needs to be balanced by a requirement for practitioners to be competent, as is the case for doctors and nurses. Regulation almost exclusively deals with conduct, but the unique risks posed by alternative medicine are not addressed by this. The harms which will arise from licensing practitioners who are not required to show evidence of competence and efficacy are:

  • Harm 1. Misdiagnosis of serious conditions.  Alternative practitioners offer to diagnose illnesses without proper training. This can lead to avoidable death, such as treating an ectopic pregnancy with ginger.
  • Harm 2. Withdrawal from treatment. Clients of alternative practitioners risk being encouraged to withdraw from life saving treatments in favours of treatments without evidence, as in the death of baby Gloria Thomas.
  • Harm 3. Harms arising from the nature of the alternative practice, but not covered by the regulatory framework, such as adulterated herbal remedies.
  • Harm 4.  Lack of informed consent. If alternative practitioners are not required to study or show evidence of efficacy, how can they inform patients of their options?
  • Harm 5. Equity. Doctors and nurses have to use evidence based methods, but it is proposed that alternative practitioners are not held to this standard. Is this fair? Health Minsters should ask themselves if they advocate withdrawing the requirement for evidence based treatment from doctors and nurses. If not, why not? And if not, why should alternative practitioners be treated differently?
  • Harm 6. Promotion of irrationality. If no evidence of efficacy is required, where do you draw the line? Witch doctoring is a ‘traditional practice’ in communities in the UK, and astrology is used by some herbal healers.
  • Harm 7. Opportunity Costs. If no evidence of efficacy is required of alternative medicine, significant sums will be wasted by individuals and by the NHS.
  • Harm 8. Reputational harms for UK Higher Education. UK Honours Degrees are based on the ability to think critically and to assess evidence. Alternative medicine Degree programmes do not require this. These positions are not compatible.
  • Harm 9.  Health care futures. We are making slow but steady progress on health indicators through the use of evidence based methods. Why should the requirement for evidence be abandoned now?

Instead, safe regulation of alternative practitioners should be through:

  • The Medicines and Healthcare Products Regulatory Agency
  • The Office of Trading Standards via the Unfair Trading Consumer Protection Regulations,
  • A new Health Advertising Standards Authority, modelled on the successful Cancer Act 1939.

The first two recommendations for effective regulation are much the same as mine, but the the third one is interesting. The problem with the Cancer Act (1939), and with the Unfair Trading regulations, is that they are applied very erratically. They are the responsibility of local Trading Standards offices, who have, as a rule, neither the expertise nor the time to enforce them effectively. A Health Advertising Standards Authority could perhaps take over the role of enforcing existing laws. But it should be an authority with teeth. It should have the ability to prosecute. The existing Advertising Standards Authority produces, on the whole, excellent judgements but it is quite ineffective because it can do very little.

A letter from an acupuncturist

I had a remarkable letter recently from someone who actually practises acupuncture. Here are some extracts.

“I very much enjoy reading your Improbable Science blog. It’s great to see good old-fashioned logic being applied incisively to the murk and spin that passes for government “thinking” these days.”

“It’s interesting that the British Acupuncture Council are in favour of statutory regulation. The reason is, as you have pointed out, that this will confer a respectability on them, and will be used as a lever to try to get NHS funding for acupuncture. Indeed, the BAcC’s mission statement includes a line “To contribute to the development of healthcare policy both now and in the future”, which is a huge joke when they clearly haven’t got the remotest idea about the issues involved.”

“Before anything is decided on statutory regulation, the British Acupuncture Council is trying to get a Royal Charter. If this is achieved, it will be seen as a significant boost to their respectability and, by implication, the validity of state-funded acupuncture. The argument will be that if Physios and O.T.s are Chartered and safe to work in the NHS, then why should Chartered Acupuncturists be treated differently? A postal vote of 2,700 BAcC members is under-way now and they are being urged to vote “yes”. The fact that the Privy Council are even considering it, is surprising when the BAcC does not even meet the requirement that the institution should have a minimum of 5000 members (http://www.privy-council.org.uk/output/Page45.asp). Chartered status is seen as a significant stepping-stone in strengthening their negotiating hand in the run-up to statutory regulation.”

“Whatever the efficacy of acupuncture, I would hate to see scarce NHS resources spent on well-meaning, but frequently gormless acupuncturists when there’s no money for the increasing costs of medical technology or proven life-saving pharmaceuticals.”

“The fact that universities are handing out a science degree in acupuncture is a testament to how devalued tertiary education has become since my day. An acupuncture degree cannot be called “scientific” in any normal sense of the term. The truth is that most acupuncturists have a poor understanding of the form of TCM taught in P.R.China, and hang on to a confused grasp of oriental concepts mixed in with a bit of New Age philosophy and trendy nutritional/life-coach advice that you see trotted out by journalists in the women’s weeklies. This casual eclectic approach is accompanied by a complete lack of intellectual rigour.

My view is that acupuncturists might help people who have not been helped by NHS interventions, but, in my experience, it has very little to do with the application of a proven set of clinical principles (alternative or otherwise). Some patients experience remission of symptoms and I’m sure that is, in part, bound up with the psychosomatic effects of good listening, and non-judgemental kindness. In that respect, the woolly-minded thinking of most traditional acupuncturists doesn’t really matter, they’re relatively harmless and well-meaning, a bit like hair-dressers. But just because you trust your hairdresser, it doesn’t mean hairdressers deserve the Privy Council’s Royal Charter or that they need to be regulated by the government because their clients are somehow supposedly “vulnerable”.”

Earlier postings on the Pittilo recommendations

A very bad report: gamma minus for the vice-chancellor http://www.dcscience.net/?p=235

Article in The Times (blame subeditor for the horrid title)
http://www.timesonline.co.uk/tol/comment/columnists/guest_contributors/article4628938.ece

Some follow up on The Times piece
http://www.dcscience.net/?p=251

The Health Professions Council breaks its own rules: the result is nonsense
http://www.dcscience.net/?p=1284

Chinese medicine -acupuncture gobbledygook revealed
http://www.dcscience.net/?p=1950

Consultation opens on the Pittilo report: help top stop the Department of Health making a fool of itself  http://www.dcscience.net/?p=2007

Why degrees in Chinese medicine are a danger to patients  http://www.dcscience.net/?p=2043

One month to stop the Department of Health endorsing quackery.  The Pittilo questionnaire, http://www.dcscience.net/?p=2310
 

Follow-up

More boring politics, but it matters.  The two main recommendations of this Pittilo report are that

  • Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine should be subject to statutory regulation by the Health Professions Council
  • Entry to the register should normally be through a Bachelor degree with Honours

For the background on this appalling report, see earlier posts.

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

The Times (blame subeditor for the horrid title), and some follow up on the Times piece

The Health Professions Council breaks its own rules: the result is nonsense

Chinese medicine -acupuncture gobbledygook revealed

Consultation opens on the Pittilo report: help stop the Department of Health making a fool of itself 

Why degrees in Chinese medicine are a danger to patients

The Department of Health consultation shuts on November 2nd.  If you haven’t responded yet, please do.  It would be an enormous setback for reason and common sense if the government were to give a stamp of official approval to people who are often no more than snake-oil salesman.

Today I emailed my submission to the Pittilo consultation to the Department of Health, at HRDListening@dh.gsi.gov.uk

The submission

I sent the following documents, updated versions of those already posted earlier.

  • Submission to the Department of Health, for the consultation on the Pittilo report [download pdf].
  • What is taught in degrees in herbal and traditional Chinese medicine? [download pdf]
  • $2.5B Spent, No Alternative Med Cures [download pdf]
  • An example of dangerous (and probably illegal) claims that are routinely made by TCM practitioners [download pdf]f

I also completed their questionnaire, despite its deficiencies. In case it is any help to anyone, this is what I said:

The questionnaire

Q1: What evidence is there of harm to the public currently as a result of the activities of acupuncturists, herbalists and traditional Chinese medicine practitioners? What is its likelihood and severity?

Harm

No Harm

Unsure

Comment

The major source of harm is the cruel deception involved in making false claims of benefit to desperate patients. This applies to all three.

In the case of herbal and TCM there is danger from toxicity because herbal preparations are unstandardised so those that do contain an active ingredient are given in an unknown dose. This is irresponsible and dangerous (but would not be changed by the proposals for regulation).

In addition TCM suffers from recurrent problems of contamination with heavy metals, prescription drugs and so on. Again this would not be the business of the proposed form of regulation.

Q2: Would this harm be lessened by statutory regulation? If so, how?

Yes

No

Unsure

The proposed form of regulation would be no help at all. The HPC has already said that it is not concerned with whether or not the drug works, and, by implication, does not see itself as preventing false health claims (just as the GCC doesn’t do this). False claims are the responsibility of Trading Standards who are meant to enforce the Consumer Protection Unfair Trading Regulations (May 2008), though they do not at present enforce them very effectively. Also Advertisng Standards. The proposed regulation would not help, and could easily hinder public safety as shown by the fact that the GCC has itself been referred to the Advertisng Standards Authority.

The questions of toxicity and contamination are already the responsibility of Trading Standards and the MHRA. Regulation by the HPC would not help at all. The HPC is not competent to deal with such questions.

Q3: What do you envisage would be the benefit to the public, to practitioners and to businesses, associated with introducing statutory regulation?

Significant benefit

Some benefit

No benefit

Unsure

This question is badly formulated because the answer is different according to whether you are referring to the public, to practitioners or to businesses.

The public would be endangered by the form of regulation that is proposed, as is shown very clearly by the documents that I have submitted separately.

In the case of practitioners and businesses, there might be a small benefit, if the statutory regulation gave the impression that HM and TCM had government endorsement and must therefore be safe and effective.

There is also one way that the regulation could harm practitioners and businesses. If the HPC received a very large number of complaints about false health claims, just as the GCC has done recently, not only would it cost a large amount of money to process the claims, but the attendant bad publicity could harm practitioners. It is quite likely that this would occur since false claims to benefit sick people are rife in the areas of acupuncture, HM and TCM.

Q4: What do you envisage would be the regulatory burden and financial costs to the public, to practitioners, and to businesses, associated with introducing statutory regulation? Are these costs justified by the benefits and are they proportionate to the risks? If so, in what way?

Justified

Not Justified

Unsure

Certainly not justified. Given that I believe that the proposed form of regulation would endanger patients, no cost at all would be justified. But even if there were a marginal benefit, the cost would be quite unjustified. The number of practitioners involved is very large. It would involve a huge expansion of an existing quango, at a time when the government is trying to reduce the number of quangos. Furthermore, if the HPC were flooded with complaints about false health claims, as the GCC has been, the costs in legal fees could be enormous.

Q5: If herbal and TCM practitioners are subject to statutory regulation, should the right to prepare and commission unlicensed herbal medicines be restricted to statutorily regulated practitioners?

Yes

No

Unsure

I don’t think it would make much difference. The same (often false) ideas are shared by all HM people and that would continue to be the same with or without SR.

Q6: If herbal and TCM practitioners are not statutorily regulated, how (if at all) should unlicensed herbal medicines prepared or commissioned by these practitioners be regulated?

They could carry on as now, but the money that would have been spent on SR should instead be used to give the Office of Trading Standards and the MHRA the ability to exert closer scrutiny and to enforce more effectively laws that already exist. Present laws, if enforced, are quite enough to protect the public.

Q7: What would be the effect on public, practitioners and businesses if, in order to comply with the requirements of European medicines legislation, practitioners were unable to supply manufactured unlicensed herbal medicines commissioned from a third party?

Significant effect

Some effect

No effect

Unsure

European laws,especialliy in food area, are getting quite strict about the matters of efficacy. The proposed regulation, which ignores efficacy, could well be incompatible with European law, if not now, then soon. This would do no harm to legitimate business though it might affect adversely businesses which make false claims (and there are rather a lot of the latter).

Q8: How might the risk of harm to the public be reduced other than by orthodox statutory regulation? For example by voluntary self-regulation underpinned by consumer protection legislation and by greater public awareness, by accreditation of voluntary registration bodies, or by a statutory or voluntary licensing regime?

Voluntary self-regulation

Accreditation of voluntary bodies

Statutory or voluntary licensing

Unsure

I disagree with the premise, for reasons given in detail in separate documents. I believe that ‘orthodox statutory regulation’, if that means the Pittilo proposals, would increase, not decrease, the risk to the public. Strengthening the powers of Trading Standards, the MHRA and such consumer protection legislation would be far more effective in reducing risk to the public than the HPC could ever be.  Greater public awareness of the weakness of the evidence for the efficacy of these treatments would obviously help too, but can’t do the job on its own.

Q10: What would you envisage would be the benefits to the public, to practitioners, and to businesses, for the alternatives to statutory regulation outlined at Question 8?

It depends on which alternative you are referring to. The major benefit of enforcement of existing laws by Trading Standards and/or the MHRA would be (a) to protect the public from risk, (b) to protect the public from health fraud and (c) almost certainly lower cost to the tax payer.

Q11: If you feel that not all three practitioner groups justify statutory regulation, which group(s) does/do not and please give your reasons why/why not?

Acupuncture

Herbal Medicine

TCM

Unsure

None of them. The differences are marginal. In the case of acupuncture there has been far more good research than for HM or TCM. But the result of that research is to show that in most cases the effects are likely to be no more than those expected of a rather theatrical placebo. Furthermore the extent to which acupuncture has a bigger effect than no-acupuncture in a NON-BLIND comparison, is usually too small and transient to offer any clinical advantage (so it doesn’t really matter whether the effect is placebo or not, it is too small to be useful).

In the case of HM, and even more of TCM, there is simply not enough research to give much idea of their usefulness,  with a small handful of exceptions.

This leads to a conclusion that DH seems to have ignored in the past. It makes absolutely no sense to talk about “properly trained practitioners” without first deciding whether the treatments work or not. There can be no such thing as “proper training” in a discipline that offers no benefit over placebo. It is a major fault of the Pittilo recommendations that they (a) ignore this basic principle and (b) are very over-optimistic about the state of the evidence.

Q12: Would it be helpful to the public for these practitioners to be regulated in a way which differentiates them from the regulatory regime for mainstream professions publicly perceived as having an evidence base of clinical effectiveness? If so, why? If not, why not?

Yes

No

Unsure

It might indeed be useful if regulation pointed out the very thin evidence base for HM and TCM but it would look rather silly. The public would say how can it be that the DH is granting statutory regulation to things that don’t work?

Q13: Given the Government’s commitment to reducing the overall burden of unnecessary statutory regulation, can you suggest which areas of healthcare practice present sufficiently low risk so that they could be regulated in a different, less burdensome way or de-regulated, if a decision is made to statutorily regulate acupuncturists, herbalists and traditional Chinese medicine practitioners?

Yes

No

Unsure

As stated above, the.only form of regulation that is needed, and the only form that would protect the public, is through consumer protection regulations, most of which already exist (though they are enforced in a very inconsistent way). Most statutory regulation is objectionable, not on libertarian grounds, but because it doesn’t achieve the desired ends (and is expensive). In this case of folk medicine, like HM and TCM, the effect would be exactly the opposite of that desired as shown in separate documents that I have submitted to the consultation.

Q14: If there were to be statutory regulation, should the Health Professions Council (HPC) regulate all three professions? If not, which one(s) should the HPC not regulate?

Yes

No

Unsure

The HPC should regulate none of them. It has never before regulated any form of alternative medicine and it is ill-equipped to do so. Its statement that it doesn’t matter that there is very little evidence that the treatments work poses a danger to patients (as well as being contrary to its own rules).

Q15: If there were to be statutory regulation, should the Health Professions Council or the General Pharmaceutical Council/Pharmaceutical Society of Northern Ireland regulate herbal medicine and traditional Chinese medicine practitioners?

HPC

GPC/PSNI

Unsure

Neither. The GPC is unlikely to care about whether the treatments work any more than the RPSGB did, or the GCC does now. The problems would be exactly the same whichever body did it.

Q16: If neither, who should and why?

As I have said repeatedly, it should be left to Trading Standards, the MHRA and other consumer protection regulation.

Q17:

a) Should acupuncture be subject to a different form of regulation from that for herbalism and traditional Chinese medicine? If so, what?

Yes

No

Unsure

b) Can acupuncture be adequately regulated through local means, for example through Health and Safety legislation, Trading Standards legislation and Local Authority licensing?

Yes

No

Unsure

(a) No -all should be treated the same. Acupuncture is part of TCM

(b) Yes

Q18.

a) Should the titles acupuncturist, herbalist and [traditional] Chinese medicine practitioner be protected?

b) If your answer is no which ones do you consider should not be legally protected?

Yes

No

Unsure

No. It makes no sense to protect titles until such time as it has been shown that the practitioners can make a useful contribution to medicine (above placebo effect). That does not deny that placebos may be useful at times. but if that is all they are doing, the title should be ‘placebo practitioners’.

Q19: Should a new model of regulation be tested where it is the functions of acupuncture, herbal medicine and TCM that are protected, rather than the titles of acupuncturist, herbalist or Chinese medicine practitioner?

Yes

No

Unsure

No. This makes absolutely no sense when there is so little knowledge about what is meant by the ” functions of acupuncture, herbal medicine and TCM”.Insofar as they don’t work (better than placebo), there IS no function. Any attempt to define function when there is so little solid evidence (at least for HM and TCM) is doomed to failure.

Q20: If statutory professional self-regulation is progressed, with a model of protection of title, do you agree with the proposals for “grandparenting” set out in the Pittilo report?

Yes

No

Unsure

No. I believe the Pittilo report should be ignored entirely. The whole process needs to be thought out again in a more rational way.

Q22: Could practitioners demonstrate compliance with regulatory requirements and communicate effectively with regulators, the public and other healthcare professionals if they do not achieve the standard of English language competence normally required for UK registration? What additional costs would occur for both practitioners and regulatory authorities in this case?

Yes

No

Unsure

No. It is a serious problem, in TCM especially, that many High Street practitioners speak hardly any English at all. That adds severely to the already considerable risks. There would be no reliable way to convey what was expected of them. it would be absurd for the taxpayer to pay for them to learn English for the purposes of practising TCM (of course there might be the same case as for any other immigrant for teaching English on social grounds).

Q23: What would the impact be on the public, practitioners and businesses (financial and regulatory burden) if practitioners unable to achieve an English language IELTS score of 6.5 or above are unable to register in the UK?

Significant impact

Some impact

No impact

Unsure

The question is not relevant. The aim of regulation is to protect the public from risk (and it should be, but isn’t, an aim to protect them from health fraud). It is not the job of regulation to promote businesses

Q24: Are there any other matters you wish to draw to our attention?

I have submitted three documents via HRDListening@dh.gsi.gov.uk. The first of these puts the case against the form of regulation proposed by Pittilo, far more fluently than is possible in a questionnaire.
Another shows examples of what is actually taught in degrees in acupuncture, HM and TCM. They show very graphically the extent to which the Pittilo proposals would endanger the public, if they were to be implemented..

Jump to follow-up

.The University of Central Lancashire (UCLAN) is the first place I asked to see teaching materials that were used on its homeopathy “BSc” course. The request was refused, and subsequent internal appeals were refused too, Clearly UCLAN had something to hide.

UClan-logo

An appeal to the information commissioner took almost two years to be judged, but the case was won. The eventual decision by the Information
Commissioner rejected all the grounds that UClan had used to evade the Freedom of Information Act.

UClan appealed against the judgement and I still haven’t got the stuff but that hardly matters now, because the course in question shut its doors. In any case, plenty of stuff from similar courses has leaked out already.

Meanwhile, in September 2008, UCLAN announced an internal review of all its courses in magic medicine, The review seemed to be genuine. For a start they asked me to give evidence to the review (something that no other university has done). They also asked Michael Eslea to give evidence. He is the UCLAN psychologist, whose magnificent open letter probably tipped the authorities into holding the review.

Just in case it is useful to anyone, here is a copy of the written evidence that I sent [download pdf],

Report of the Working Party on the Review of issues associated with Homeopathy, Acupuncture and Chinese Herbal Medicine

1. Introduction

As a consequence of concerns expressed by some colleagues within the University of Central Lancashire (UCLan) Dr Malcolm McVicar, Vice Chancellor appointed a working party to review the issues associated with the University offering courses in Homeopathy, Acupuncture and Chinese Herbal Medicine.

MEMBERSHIP:

Eileen Martin (Chair)                Pro-Vice Chancellor and Dean of Faculty of Health and Social Care 
Professor Gordon Bromage      Head of Centre for Astrophysics
Professor Malcolm Edmunds    Emeritus; Built and Natural Environment
Professor Doris Schroeder        Director of Centre for Professional Ethics
Elaine Austin                               Project Manager, Faculty of Health and Social Care


The report was the subject of a special meeting of UCLAN’s Academic Board on 9th July 2009. The following resolutions were passed.

Resolutions

R1    That further minor revisions be made to the report prior to publication on the University’s website;

R2   That the University refrain from offering any practitioner-qualifying courses in Homeopathy, Acupuncture and Chinese Herbal Medicine until such disciplines have achieved statutory regulation status;

R3    That the University consider offering a limited number of postgraduate research studentships (leading to Masters by Research of PhD) to suitably qualified UCLan students and staff in these disciplines. They should have interdisciplinary supervisory teams to facilitate development of a broad range of research skills and to contribute to the generation of knowledge in CAM;

R4   That the University consider how more interdisciplinary teaching can be achieved, where appropriate, within both undergraduate and postgraduate teaching to facilitate greater exposure to subject expertise and different paradigms.

Resolutions 1, 3 and 4 say very little. Resolution 4 sounds thoroughly relativist. We are talking about medicine, about treating sick patients. There is only one “paradigm”. That is to find treatments that are as effective and safe as possible. There aren’t two sorts of medicine, regular and alternative. There is just medicine that works and medicine that doesn’t work. It’s a good illustration of DC’s rule number 2, “never trust anyone who uses the word paradigm”.

Resolution 2 is the really interesting one, because none if the topics, Homeopathy, Acupuncture and Chinese Herbal Medicine, is subject to statutory regulation.

If taken literally, resolution 2 means that all the UCLan courses in alternative medicine will close their doors. Bafflingly, this inevitable conclusion is not stated explicitly.

At least resolution 2 means that homeopathy, already closed, will stay closed. It is never likely to get statutory regulation.

For practical purposes, we can ignore for the moment the obvious fact that statutory regulation of nonsense subjects results only in nonsense. The only forms of alternative medicine that have got “statutory regulation” at the moment are chiropractic and osteopathy. The public has not been safeguarded by the General Chiropractic Council (GCC). The GCC, on the contrary, has endangered the public by allowing false health claims to be made with impunity. Perhaps the members of the review committee had not noticed that the Simon SIngh affair has resulted in almost 600 complaints being made to the GCC? The faith of the review in statutory regulation is clearly misplaced.

The Pittilo report is critical for what happens next

Acupuncture and Chinese Herbal Medicine are not subject to statutory regulation at present, so one would suppose that these degrees will close their doors too. However the infamous Pittilo report has proposed that they should become regulated by the Health Professions Council (HPC). The many problems of the Pittilo report have been documented here, in “A very bad report: gamma minus for the vice-chancellor“. There was also a high-profile critique of the report in The Times (and on this blog).

The HPC has, as one of its criteria for regulation, “evidence-based practice”. Disgracefully, the HPC has already shown its willingness to ignore its own rules and to act as statutory regulator for Acupuncture and Chinese Herbal medicine. This rather disgraceful behaviour is documented in “Health Professions Council ignores its own rules: the result is nonsense“.

The UCLAN report seems to assume that the recommendations of the Pittilo report will be accepted. But the long-awaited consultation has still not opened. We can be sure that when it does, the opposition to it will be very strong indeed.

The report in full

Here are a few comments on the report itself.    Download the full report (as of July 15th).

i have to say that when I visited Preston to give evidence, my views seem to be treated seriously, even sympathetically, so it was a great disappointment to see the outcome. So what’s wrong? The major disaster is declared early in the report.

Section 2, Context

The debate is centred on a number of key themes which relate to:-

1. The quality of and/or absence of an evidence base to support claims of the efficacy and benefits of such treatments, linked to issues of public safety/protection and professional regulation.

Sounds good. What matters about any sort of medicine is whether or not it works and whether it is safe. It therefore verges on the incredible that we read in section 4.1

“conclusions from research into the efficacy of the various CAM’s are outside the remit of this report.”

The whole point about CAM is that there is very little evidence that any of it works. So the review committee decided to ignore the most important problem of the lot.  I can’t see how any rational decision can be made without first deciding whether the treatment is better than placebo.  That, surely, is the main question, and it was dodged.

UCLAN has failed to grasp the nettle, just as the Department of Health has also consistently failed to do so.

Section 4,1  Efficacy   This section repeats the assertion, absurd to my mind, that it is possible to judge CAM courses while declining to assess whether they work or not.

Section 4.2 Role of Universities in Society.

There is universal agreement that critical thinking is crucial to the idea of a university, but the judgement of whether CAM teaches critical thinking is simply fudged. Again the report fails to grasp the nettle.

“Disagreements about critical thinking within CAMs arises because some will argue that such substantiation and assessment can occur within the discipline, whilst others will argue that the methodology for substantiation, that is evidence provision, is universal. As a result, the latter will demand that evidence is provided using methods from one field (e.g. randomised controlled trials) for use in another.”

Sadly, the report dodged the crucial judgement once again. The most obvious characteristic of every form of alternative medicine is their total lack of critical self-appraisal. It is very sad that the review committee could not bring itself to say so.

Section 4.4   Nomenclature of degrees

Recommendation
The nomenclature of courses, leading to a professional as well as an academic award, should reflect the professional route; for example Bachelor with Honours in Complementary Medicine, B Comp. Med.(Hons) or B Acupuncture (Hons).

This sounds to me like another truly pathetic fudge. What on earth is solved by changing the name of the degree? You’d still be teaching students the same load of gobbledygook and then letting them loose on sick people, whether you call it a Bachelor of Science, a Bachelor of Arts, or, as is recommended here, a Bachelor of nothing whatsoever.

Well, I suppose there is a (doubtless unintended) irony in calling CAM degrees “Bachelor of nothing whatsoever”.

Section 4.4   Ethical, non-harm and economic considerations

This section list a lot of reasons why teaching alternative medicine should be unethical. but nevertheless manages to conclude that

” . . . it is not unethical to offer courses in Homeopathy, Acupuncture and Chinese Herbal Medicine at a university.”

I find the logic by which this bizarre conclusion was reached quite impossible to follow. Like much of the rest of the report this conclusion seems to stem from a reluctance to grapple with the really important questions, like ‘does it work or not?’.

Despite this the recommendation is perhaps the most interesting of all.

Recommendation
• The University refrains from offering any CAM courses until such disciplines have achieved statutory regulation status.”

This recommendation was accepted, and passed as a resolution at Academic Board. If it is implemented now, than there will be no more alternative medicine degrees next year at the University of Central Lancashire. If and when this happens, the University must be congratulated on its return to rational medicine.

Follow-up

Michael Eslea, UCLAN’s hero in resisting nonsense from the inside, has posted on this topic.

17 July 2009. It seemed odd that that no announcement was made about the future if the remaining CAM courses at UCLAN. So I asked deputy Vice-Chancellor Patrick McGhee for clarification. After a couple of days, I got this response.

From: CTheobald@uclan.ac.uk

To: d.colquhoun@ucl.ac.uk
Subject: uclan clarification

Hi David,

I have been asked to respond to your question below on the running of acupuncture and Chinese herbal medicine at UCLan. It is correct to assume that UCLan will not be taking any new entrants onto these programmes until further notice.

Best Wishes

Chris

Chris Theobald
Corporate Communications
University of Central Lancashire

So the report may have been disappointing, but it has done the job. As several people have pointed out in comments, it would be asking too much to expect a university to say “sorry we just noticed that we have been running junk-science courses for years”. But they have done the right thing anyway.

The Health Professions Council (HPC) is yet another regulatory quango.

The HPC’s strapline is

“Working with health professionals to protect the public”

At present the HPC regulates; Arts therapists, biomedical scientists, chiropodists/podiatrists, clinical scientists, dietitians, occupational therapists, operating department practitioners, orthoptists, paramedics, physiotherapists, prosthetists/orthotists, radiographers and speech & language therapists.

These are thirteen very respectable jobs. With the possible exception of art therapists, nobody would doubt for a moment that they are scientific jobs, based on evidence. Dietitians, for example, are the real experts on nutrition (in contrast to “nutritional therapists” and the like, who are part of the alternative industry).  That is just as well because the ten criteria for registration with the HPC say that aspirant groups must have

“Practise based on evidence of efficacy”

But then came the Pittilo report, about which I wrote a commentary in the Times, and here, A very bad report: gamma minus for the vice-chancellor, and here.

Both the Pittilo report, the HPC, and indeed the Department of Health itself (watch this space), seem quite unable to grasp the obvious fact that you cannot come up with any sensible form of regulation until after you have decided whether the ‘therapy’ works or whether it is so much nonsense.

In no sense can “the public be protected” by setting educational standards for nonsense.  But this obvioua fact seems to be beyond the intellectual grasp of the quangoid box-ticking mentality.

That report recommended that the HPC should regulate also Medical Herbalists, Acupuncturists and Traditional Chinese Medicine Practitioners. Even more absurdly, it recommended degrees in these subjects, just at the moment that those universities who run them are beginning to realise that they are anti-scientific subjects and closing down degrees in them.

How could these three branches of the alternative medicine industry possibly be eligible to register with the HPC when one of the criteria for registration is that there must be “practise based on evidence of efficacy”?

Impossible, I hear you say.  But if you said that, I fear you may have underestimated the capacity of the official mind for pure double-speak.

The HPC published a report on 11 September 2008, Regulation of Medical Herbalists, Acupuncturists and Traditional Chinese Medicine Practitioners.

The report says

1. Medical herbalists, acupuncturists and traditional Chinese medicine practitioners should be statutorily regulated in the public interest and for public safety reasons.

2. The Health Professions Council is appropriate as the regulator for these professions.

3. The accepted evidence of efficacy overall for these professions is limited, but regulation should proceed because it is in the public interest.

But the last conclusion contradicts directly the requirement for “practise based on evidence of efficacy”.  I was curious about how this contradiction
could be resolved so I sent a list of questions.  The full letter is here.

The letter was addressed to the president of the HPC, Anna van der Gaag, but with the customary discourtesy of such organisations, it was not answered by her but by Michael Guthrie, Head of Policy and Standards   He said

“Our Council considered the report at its meeting in July 2008 and decided that the regulation of these groups was necessary on the grounds of public protection. The Council decided to make a recommendation to the Secretary of State for Health that these groups be regulated.
http://www.hpc-uk.org/assets/documents/100023FEcouncil_20080911_enclosure07.pdf
“.

This, of course, doesn’t answer any of my questions. It does not explain how the public is protected by insisting on formal qualifications, if the qualifications
happen to teach mythical nonsense. Later the reply got into deeper water.

“I would additionally add that the new professions criteria are more focused on the process and structures of regulation, rather than the underlying rationale for regulation – the protection of members of the public. The Council considered the group’s report in light of a scoring against the criteria. The criteria on efficacy was one that was scored part met. As you have outlined in your email (and as discussed in the report itself) the evidence of efficacy (at least to western standards) is limited overall, particularly in the areas of herbal medicines and traditional Chinese medicine. However, the evidence base is growing and there was a recognition in the report that the individualised approach to practice in these areas did not lend themselves to traditional RCT research designs.”

Yes, based on process and structures (without engaging the brain it seems). Rather reminiscent of the great scandal in UK Social Services. It is right in one respect though.

The evidence base is indeed growing, But it is almost all negative evidence. Does the HPC not realise that? And what about “at least by Western standards”?   Surely the HPC is not suggesting that UK health policy should be determined by the standards of evidence of Chinese herbalists?  Actually it is doing exactly that since its assessment of evidence was based on the Pittilo report in which the evidence was assessed (very badly) by herbalists.

One despairs too about the statement that

“there was a recognition in the report that the individualised approach to practice in these areas did not lend themselves to traditional RCT research designs”

Yes of course the Pittilo report said that, because it was written by herbalists! Had the HPC bothered to read Ben Goldacre’s column in the Guardian they would have realised that there is no barrier at all to doing proper tests. It isn’t rocket science, though it seems that it is beyond the comprehension of the HPC.

So I followed the link to try again to find out why the HPC had reached the decision to breach its own rules. Page 10 of the HPC Council report says

3. The occupation must practise based on evidence of efficacy This criterion covers how a profession practises. The Council recognizes the centrality of evidence-based practice to modern health care and will assess applicant occupations for evidence that demonstrates that:

  • Their practice is subject to research into its effectiveness. Suitable evidence would include publication in journals that are accepted as
    learned by the health sciences and/or social care communities
  • There is an established scientific and measurable basis for measuring outcomes of their practice. This is a minimum—the Council welcomes
    evidence of there being a scientific basis for other aspects of practice and the body of knowledge of an applicant occupation
  • It subscribes to the ethos of evidence-based practice, including being open to changing treatment strategies when the evidence is in favour
    of doing so.

So that sounds fine. Except that research is rarely published in “journals that are accepted as learned by the health sciences”. And of course most of the good evidence is negative anyway. Nobody with the slightest knowledge of the literature could possibly think that these criteria are satisfied by Medical Herbalists, Acupuncturists and Traditional Chinese Medicine Practitioners.

So what does the HPC make of the evidence?  Appendix 2 tells us. It goes through the criteria for HPS registration.

“Defined body of knowledge:  There is a defined body of knowledge, although approaches to practice can vary within each area.”

There is no mention that the “body of knowledge” is, in many cases, nonsensical gobbledygook and, astonishingly this criterion was deemed to be “met”!.

This shows once again the sheer silliness of trying to apply a list of criteria without first judging whether the subject is based in reality,

Evidence of efficacy. There is limited widely accepted evidence of efficacy, although this could be partly explained by the nature of the professions in offering bespoke treatments to individual patients. This criterion is scored part met overall.

Sadly we are not told who deemed this criterion to be “part met”. But it does say that “This scoring has been undertaken based on the information outlined in the [Pittilo] report”. Since the assessment of evidence in that report was execrably bad (having been made by people who would lose their jobs if
they said anything negative). it is no wonder that the judgement is overoptimistic!
Did the HPC not notice the quality of the evidence presented in the Pittilo report?   Apparently not.  That is sheer incompetence.

Nevertheless the criterion was not “met”, so they can’t join HPC, right?   Not at all. The Council simply decided to ignore its own rules.

On page 5 of the Council’s report we see this.

The Steering Group [Pittilo] argues that a lack of evidence of efficacy should not prevent regulation but that the professions should be encouraged and funded to strengthen the evidence base (p.11, p. 32, p.34).

This question can be a controversial area and the evidence base of these professions was the focus of some press attention following the report’s publication. An often raised argument against regulation in such circumstances is that it would give credibility in the public’s eyes to treatments that are not proven to be safe or efficacious.

This second point is dead right, but it is ignored. The Council then goes on to say

In terms of the HPC’s existing processes, a lack of ‘accepted’ evidence of efficacy is not a barrier to producing standards of proficiency or making decisions about fitness to practise cases.

This strikes me as ludicrous, incompetent, and at heart, dishonest.

There will be no sense in policy in this area until the question of efficacy is referred to NICE.  Why didn’t the HPC recommend that?  Why has it not been done?

One possible reason is that I discovered recently that, although there are two scientific advisers in the Department of Health,. both of them claim that it is “not their role” to give scientific advice in this area.  So the questions get referred instead to the Prince of Wales Foundation. That is no way to run a ship.

The fact of the matter is that the HPC, like so many other regulatory agencies, fails utterly to protect the public from fraudulent and incompetent practitioners. In fact it actually protects them, in the same way that the financial ‘regulators’ protected fraudulent bankers.  They all seem to think that ticking boxes and passing exams is an effective process. Even if the exams require you to memorise that amethysts “emit high Yin energy so transmuting lower energies and clearing and aligning energy disturbance as all levels of being”.