Anna van der Gaag
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.
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
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.
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.
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.
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.
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.
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.
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.”
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.
Instead, safe regulation of alternative practitioners should be through:
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)
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 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
The much-delayed public consultation on the Pittilo report has just opened.
It is very important that as many people as possible respond to it. It’s easy to say that the consultation is sham. It will be if it is left only to acupuncturists and Chinese medicine people to respond to it. Please write to them before the closing date, November 2nd 2009. The way to send your evidence is here.
There is a questionnaire that you can complete, with the usual leading questions. Best do it anyway, but I’d suggest also sending written evidence as attachment too. I just got from DoH the email address where you can send it. They said
|if you have material you wish to send which you can’t easily “shoehorn” into the questionnaire, please send it to the following mailbox:
Here are three documents that I propose to submit in response to the consultation.I ‘d welcome criticisms that might make it more convincing. Use any parts of them you want in your own response.
- 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]
I’ve written quite a lot about the Pittilo report already, in particular A very bad report: gamma minus for the vice-chancellor, and in The Times (see also the blog version).
Intriguingly, these posts are at number 2 in a Google search for “Michael Pittilo”.
Briefly, the back story is this.
It is now over a year since the Report to Ministers from “The Department of Health Steering Group on the Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK” [download the report].
The chair of the steering group was Professor R. Michael Pittilo, Principal and Vice-Chancellor of The Robert Gordon University, Aberdeen. The reason thet the report is so disastrously bad in its assessment of evidence is that it was written entirely by people with vested interests.
The committee consisted of five acupuncturists, five herbalists and five representatives of traditional Chinese medicine (plus eleven observers). There was not a single scientist or statistician to help in the assessment of evidence. And it shows: The assessment of the evidence in the report was execrable. Every one of the committee members would have found themselves out of work if they had come to any conclusion other than that their treatment works, Disgracefully, these interests were not declared in the report, though they are not hard to find. The university of which the chair is vice-chancellor runs a course in homeopathy, the most discredited of the popular forms of alternative medicine. That tells you all you need to know about the critical faculties of Michael Pittilo.
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 normally be through a Bachelor degree with Honours
Let’s consider the virtue of these two recommendations.
Regulation by the Health Professions Council (HPC) breaks their own rules
For a start, this should be ruled out by the HPC’s own rules, which require “Practise based on evidence of efficacy” as a condition for registration. Since there is practically no “evidence of efficacy”, it follows that the HPC can’t regulate acupuncture, herbal and Chinese medicine as Pittilo recommends. Or so you’d think. But the official mind seems to have an infinite capacity for doublespeak. 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.
In other words, the HPC simply decided to ignore its own rules, Its excuse for doing so is that regulation would protect “public safety” . But it simply would not do that. It is ell known that some Chinese herbs are adulterated with dangerous substances, but laws against that already exist. Trading Standards are much more likely to take appropriate action than the HPC. The Medicines and Health Regulatory Authority (MHRA) already deals with the licensing of herbal medicines. and, despite the fact that it recently betrayed its trust by allowing them to be labelled in a misleading way, they are the people to do it, not the HPC.
The Pittilo report (page 11) says
In future, it is hoped that more Government funding can be allocated to research into traditional/herbal medicines and acupuncture and that grants will become available to encourage practitioners to undertake postgraduate research work.
So they are asking for more government money.
In March 2007, the Chinese Government pledged to spend over $130 million over the next five years on research into the effectiveness of traditional Chinese medicine. It is to be hoped that this money will be targeted effectively to evaluate TCM.
It seems to have escaped the notice of Pittilo that roughly 100 percent of trials of Chinese medicine done in China come out positive. Elsewhere, very few come out positive,(see Vickers et al., 1998, Controlled Clinical Trials, 19, 159-166: download reprint) The Department of Health would be unwise to rely on Chinese research. Remember that modern acupuncture was not so much a product of ancient wisdom, but rather it stems from nationalist propaganda by Mao Tse-Tung, who needed a cheap way to keep the peasants quiet, though he was too sensible to use it himself.
The HPC report (page 5) cites these with the words
” . . . a lack of evidence of efficacy should not prevent regulation but that the professions should be encouraged and funded to strengthen the evidence base.”
This sentence seems to assume that the outcomes of research will be to strengthen the evidence base. Thus far, precisely the opposite has been the case. The Pittilo group has apparently not noticed that the US National Institutes of Health has already spent a billion dollars on research in alternative medicine and failed to come up with a single effective treatment. There are better ways to spend money on health. See, for example $2.5B Spent, No Alternative Med Cures found. .An enornous amount of research has already been done and the outcomes have produced no good treatments,
The proposed regulation would endanger the public, not protect it.
The excuse given by the HPC for breaking its own rules is that it should do so to protect the public.
Likewise Ann Keen, Health Minister, said:
“Patient safety is paramount, whether people are accessing orthodox health service treatments or using alternative treatments”
So first we need to identify what dangers are posed by acupuncture, herbal medicine and traditional Chinese medicine.
- Acupuncture is fairly safe. Its biggest danger lies in the unjustified claims that are routinely made for what can be achieved by being impaled by needles. This poses a danger that people may use acupuncture in place of treatments that work
- Herbal medicines are unstandardised, so even the very few that may work are dangerous to patients because the dose of active principle is unknown and varies from one batch to another. Taking a herbal medicine is a bit like swallowing a random number of tablets, False health claims pose a danger to patients too, when they cause patients to avoid treatments that work.
- Traditional Chinese Medicine is probably the most dangerous. Like the other two, the medicines are unstandardised so the dose is never known. False health claims abound. And in addition to these dangers, many cases have been found of Chinese medicines being adulterated with poisonous substances or with conventional drugs.
The form of regulation proposed by Pittilo would do little or nothing to protect the public from any of these dangers.
The proposals accept the herbal and Chinese medicine as traditionally practised. Nothing would be done about one of the major dangers, the lack of standardisation. That is a problem that was solved by pharmacologists in the 1930s, when international standards were set for the biological activity of things like tincture of digitalis, and assays were devised so that different batches could be adjusted to the same potency. Now, 80 years later, it is being proposed by Pittilo that we should return to the standards of safety that existed at the beginning of the last century. That is a threat to public safety., but the proposed regulation would do nothing whatsoever to protect the public from this dangerous practice. On the contrary, it would give official government sanction to it.
The other major danger is that patients are deceived by false health claims. This is dangerous (as well as dishonest) because it can cause patients to avoid treatments that work better, The internet abounds with claims that herbs can cure anything from diabetes to cancer. Many are doubtless illegal, but regulators like the HPC have traditionally ignored such claims: they are left to Trading Standards, Advertising Standards and the Medicines and Health Regulatory Authority (MHRA) to deal with. The MHRA already also has responsibility for monitoring side effects. The HPC would not do this.
The analogy with chiropractic and the GCC
The foolishness of allowing statutory regulation for unproven treatments has recently been illustrated quite dramatically by the case of chiropractic. Chiropractors have had statutory regulation by the General Chiropractic Council, which was established by the Chiropractors Act of 1994. The British Chiropractic Association (BCA) recently decided to sue the science writer, Simon Singh, for defamation when he cast doubt on some of the claims made by chiropractors, in particular their claims to be able to cure colic and asthma in children. That led to close examination of the claims. In fact there is no reason to think that spinal manipulation works for asthma, or that it works for colic. In fact there is quite good evidence that the claims are false. The result was that about 600 well-justified complaints have been lodged with the GCC (enough to bankrupt the GCC if the complaints are dealt with properly).
The point of this story is that the statutory regulator had nothing whatsoever to prevent these false health claims being made. Two of the complaints concern practices run by the chair of the GCC. Worse, the GCC actually endorsed such claims. The statutory regulator saw its duty to defend chiropractic (apart from a handful of cases of sexual misdemeanours), not to protect the patient from false health claims. The respectability conferred by statutory regulation made false health claims easier and endangered the public. It would be a disaster if the same mistake were made again.
On 11th December 2008 I got a letter form the HPC which said
in our opinion a lack of evidence of efficacy would not impede our ability to set standards or deal with complaints we receive. The vast majority of cases we consider are related to conduct.
But perhaps that is because they haven’t tried “regulating” quacks before. Now that the public is far more conscious about health fraud than it used to be, one can predict confidently that the HPC would be similarly overwhelmed by a deluge of complaints about the unjustified health claims made by acupuncturists, herbal medicine and traditional Chinese medicine practitioners. There is no shortage of them to complain about.
The education problem
The Pittilo report recommends that the entry level for registration should be a bachelors degree with honours. At first sight it seems reasonable to ask that practitioners should be ‘properly qualified’, but when one looks at what is actually taught on these degrees it becomes clear that they endanger, rather than protect, the public,
There are two very big problems with this recommendation.
Firstly, you can’t have a bachelors degree with honours until after you have decided whether or not there is anything useful to teach. If and when any of the subjects under consideration and shown to work to a useful extent, then it would be quite reasonable to establish degrees in them. Even the report does not pretend seriously that that stage has been reached. The proposal to set up degrees in subjects, at least some of which are quite likely to have no more than placebo value, is self-evidently nonsense,
The time for degrees, and the time for government endorsement by statutory regulation, is after the therapies have been shown to work, not before.
The absurdity of thinking that the public will be protected because a practitioner has a degree in, say, acupuncture, is shown with startling clarity by a recently revealed examination paper in acupuncture’
You can download the entire exam paper. Here are a few highlights from it.
So students, in 2009, are being taught the crudest form of vitalism.
Teaching of traditional Chinese medicine is just as bad. Here are two slides from a course run by the University of Westminster.
The first ‘explains’ the mysterious and entirly mythical “Qi”.
So “Qi” means breath, air, vapour, gas, energy, vitalism. This is meaningless nonsense.
The second slide shows the real dangers posed by the way Chinese medicine is taught, The symptoms listed at the top could easily be a clue to serious illness, yat students are taught to treat them with ginger. Degrees like this endanger the public.
There are more mind-boggling slides from lectures on Chinese medicine and cancer: they show that what students are being taught is terrifyingly dangerous to patients.
It is entirely unacceptable that students are being taught these ancient myths as though they were true, and being encouraged to treat sick people on their basis. The effect of the Pittilo recommendations would be to force new generations of students to have this sort of thing forced on them. In fact the course for which this exam was set has already closed its doors. That is the right thing to do.
Here’s another example. The course leader for “BSc (Hons) Herbal Medicine” at the Univsrsity of Central Lancashire is Graeme Tobyn BA. But Tobyn is not only a herbalist but also an astrologer. In an interview he said
“At the end I asked her if I could cast her horoscope. She threw up her hands and said, ‘I knew this would happen if I came to an alternative practitioner.”
“I think the ruler of the ascendant was applying to Uranus in the ninth house, which was very pertinent.”
This would be preposterous even in the life style section of a downmarket women’s magazine, The Pittilo report wants to make degrees run my people like this compulsory. Luckily the Univerity of Central Lancashire is much more sensible and the course is being closed.
The matter is, in any case, being taken out of the hands of the government by the fact that universities are closing degrees in complementary medicine, including courses in some of those under discussion here, The University of Salford and the University of Central Lancashire have recently announced the closure of all the degree programmes in complementary and alternative medicine. The largest provider of such degrees, the University of Westminster has already shut down two of them, and the rest are being assessed at the moment. It is likely that the rest will be closed in the future.
The revelation that Westminster had been teaching its first year students that “amethysts emit high yin energy” and that students had been taught to diagnose disease and choose treatments by means of a dowsing pendulum, showed very clearly the sort of utter nonsense that undergraduates were being forced to learn to get a ‘bachelors degree with honours’. It stretches credulity to its limits to imagine that the public is protected by degrees like this. Precisely the opposite is true. The universities have recognised this, and shut the degrees. One exception is Professor Pittilo’s own university which continues to run a course in homeopathy, the most discredited of all the popular types alternative medicine.
A simpler, more effective and cheaper way to protect the public
I must certainly agree with the minister that protection of the public is an important matter. Having established that the Pittllo recommendations are more likely to endanger the public than protect them, it is essential to suggest alternative proposals that would work better.
Luckily, that is easy, because mechanisms already exist for dealing with the dangers that were listed above. The matter of adulteration, which is serious in traditional Chinese medicine, is a matter that is already the responsibility of the Office of Trading Standards. The major problem of false claims being made for treatment is also the responsibility of the Office of Trading Standards, which has a statutory duty to enforce the Unfair Trading Consumer Protection Regulations of May 2008. These laws state, for example, that
“One of the 31 commercial practices which are in all circumstances considered unfair is “falsely claiming that a product is able to cure illnesses, dysfunction or malformations”
The monitoring of false claims, and of side effects of treatments, is also the responsibility of the Medicines and Health Regulatory Authority (MHRA).
Rather than setting up complicated, expensive and ineffective ‘regulation’ by the HPC, all that need to be done is to ensure that the MHRA and/or Trading Standards have the funds to enforce existing laws. At the moment, they are not being implemented effectively, so I’d recommend that responsibility for enforcing the law against false health claims be transferred entirely to the MHRA, which has much more expertise in such matters than Trading Standards This would be both cheaper and more effective than the present system in which the responsibility is divided between the two organisations in an unclear way.
This proposal would protect the public against unsafe and adulterated treatments, and it would protect the public against false and fraudulent claims. That is what matters. It would do so more effectively,
more cheaply and more honestly than the Pittilo recommendations. There would be no reduction in patient choice either, There is no proposal to ban acupuncture, herbal medicine or traditional Chinese medicine. All that is necessary is to ensure that they don’t endanger the public.
Since the root of the problem lies in the fact that the evidence for the effectiveness is very weak. the question of efficacy, and cost-benefit ratio, should be referred to NICE. This was recommended by the House of Lords Report (2000). It is recommended again by the Smallwood report (sponsored by the Prince of Wales Foundation). It is baffling that this has not been done already. It does not seem wise to spend large amounts of money on new research at the moment, in the light of the fact that the US National Institutes of Health has already spent over $1 billion on such research without finding a single useful treatment.
The results of all this research has been to show that hardly any alternative treatment are effective. That cannot be ignored.
Recent events show that the halcyon days for alternative medicine are over. When the Pittilo report first appeared, it was greeted with derision in the media. For example, in The Times Alice Miles wrote
“This week came the publication of the Report to Ministers from the Department of Health Steering Group on the Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK. Otherwise known as twaddle.”
In the Independent, Dominic Lawson wrote
So now we will have degrees in quackery.
What, really, is the difference between acupuncture and psychic surgery?
People will no doubt continue to use it and that is their right and their responsibility. But if the government were to accept the recommendations of the Pittilo report it would be seen, quite rightly, as being anti-scientific and of posing a danger to the public.
Fortunately there is a better, and cheaper, way to protect the public.
Margaret McCartney’s blog in the Financial Times puts rhw view of a GP with her usual sense, humour and incisiveness.
“This report would, if implemented, create lots more nonsense exam papers funded by a lot more public money – and would produce practitioners without the absolutely crucial skill of how to assess evidence and reject or use it appropriately”
The Times has covered the story (with some interesting comments) Consultation on how to regulate complementary and alternative therapies
Times Higher Education UK-wide consultation on CAM regulation is launched Excellent response from Andy Lewis.
The Sun has by far the best coverage up to now, Jane Symons writes “Regulating quacks helps them prey on gullible patients“
The Health Professions Council (HPC) is yet another regulatory quango.
|The HPC’s strapline is
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.
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”.