Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
HPC
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
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.
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.
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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.
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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.”
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.
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Executive Summary
Instead, safe regulation of alternative practitioners should be through:
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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.
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“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 https://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
https://www.dcscience.net/?p=251
The Health Professions Council breaks its own rules: the result is nonsense
https://www.dcscience.net/?p=1284
Chinese medicine -acupuncture gobbledygook revealed
https://www.dcscience.net/?p=1950
Consultation opens on the Pittilo report: help top stop the Department of Health making a fool of itself https://www.dcscience.net/?p=2007
Why degrees in Chinese medicine are a danger to patients https://www.dcscience.net/?p=2043
One month to stop the Department of Health endorsing quackery. The Pittilo questionnaire, https://www.dcscience.net/?p=2310
Follow-up
This post has been translated into Belorussian..
Chinese medicine and herbal medicine are in the news at the moment. There is a real risk that the government could endorse them by accepting the Pittilo report.
In my view traditional Chinese medicine endangers people. The proposed ‘regulation’ would do nothing to protect the public. Quite on the contrary, it would add to the dangers, by giving an official stamp of approval while doing nothing for safety.
The government’s idea of improving safety is to make sure that practitioners are ‘properly trained’. But it is the qualifications that cause the danger in the first place. The courses teach ideas that are plain wrong and often really dangerous.
Why have government (and some universities) not noticed this? That’s easy to see. Governments, quangos and university validation committees simply don’t look. They tick boxes but never ask what actually goes on. Here’s some examples of what goes on for them to think about. They show clearly the sort of dangerous rubbish that is taught on some of these ‘degrees’.
These particular slides are from the University of Westminster, but similar courses exist in only too many other places. Watch this space for more details on courses at Edinburgh Napier University, Middlesex University and the University of East London
Just a lot of old myths. Sheer gobbledygook,
SO much for a couple of centuries of physiology,
It gets worse.
Plain wrong.
Curious indeed. The fantasy gobbledygook gets worse.
Now it is getting utterly silly. Teaching students that the brain is made of marrow is not just absurd, but desperately dangerous for anyone unlucky (or stupid) enough to go to such a person when they are ill.
Here’s another herbal lecture., and this time the topic is serious. Cancer.
Herbal approaches for patients with cancer.
I’ve removed the name of the teacher to spare her the acute embarrassment of having these dangerous fantasies revealed. The fact that she probably believes them is not a sufficient excuse for endangering the public. There is certainly no excuse for the university allowing this stuff to be taught as part of a BSc (Hons).
First get them scared with some bad statistics.
No fuss there about distinguishing incidence, age-standardisation and death rates. And no reference. Perhaps a reference to the simple explanation of statistics at Cancer Research UK might help? Perhaps this slide would have been better (from CDC). Seems there is some mistake in slide 2.
Straight on to a truly disgraceful statement in slide 3
The is outrageous and very possibly illegal under the Cancer Act (1939). It certainly poses a huge danger to patients. It is a direct incentive to make illegal, and untrue claims by using weasel words in an attempt to stay just on the right side of the law. But that, of course, is standard practice in alternative medicine,
Slide 11 is mostly meaningless. “Strengthen vitality” sounds good but means nothing. And “enhancing the immune system” is what alternative medicine folks always say when they can think of nothing else. Its meaning is ill-defined and there is no reason to think that any herbs do it.
The idea of a ‘tonic’ was actually quite common in real medicine in the 1950s. The term slowly vanished as it was realised that it was a figment of the imagination. In the fantasy world of alternative medicine, it lives on.
Detoxification, a marketing term not a medical one, has been extensively debunked quite recently. The use of the word by The Prince of Wales’ company, Duchy Originals recently fell foul of the Advertising Standards Authority, and his herbal ‘remedies’ were zapped by the MHRA (Medicines and Health Regulatory Authority).
And of course the antioxidant myth is a long-disproved hypothesis that has become a mere marketing term.
“Inhibits the recurrence of cancer”! That sounds terrific. But if it is so good why is it not even mentioned in the two main resources for information about herbs?
In the UK we have the National Library for Health Complementary and Alternative Medicine Specialist Library (NeLCAM), now a part of NHS Evidence. It was launched in 2006. The clinical lead was none other than Peter Fisher, clinical director of the Royal London Homeopathic Hospital, and the Queen’s homeopathic physician. The library was developed with the School of Integrated Health at the University of Westminster (where this particular slide was shown to undergraduates). Nobody could accuse these people of being hostile to magic medicine,
It seems odd, then, that NeLCAM does not seem to thnk to think that Centella asiatica, is even worth mentioning.
In the USA we have the National Center for Alternative and Complementary Medicine (NCCAM), an organisation that is so friendly to alternative medicine that it has spent a billion dollars on research in the area, though it has produced not a single good treatment for that vast expenditure. But NCCAM too does not even mention Centella asiatica in its herb list. It does get a mention in Cochrane reviews but only as a cosmetic cream and as an unproven treatment for poor venous circulation in the legs.
What on earth is a “lymph remedy”. Just another marketing term?
“especially valuable in the treatment of breast, throat and uterus cancer.“
That is a very dramatic claim. It as as though the hapless students were being tutored in doublespeak. What is meant by “especially valuable in the treatment of”? Clearly a desperate patient would interpret those words as meaning that there was at least a chance of a cure. That would be a wicked deception because there isn’t the slightest reason to think it works. Once again there this wondrous cure is not even mentioned in either NELCAM or NCCAM. Phytolacca is mentioned, as Pokeweed, in Wikipedia but no claims are mentioned even there. And it isn’t mentioned in Cochrane reviews either. The dramatic claims are utterly unfounded.
Ah the mistletoe story, again.
NHS Evidence (NeLCAM) lists three completed assessments. One concludes that more research is needed. Another concludes that “Rigorous trials of mistletoe extracts fail to demonstrate efficacy of this therapy”, and the third says “The evidence from RCTs to support the view that the application of mistletoe extracts has impact on survival or leads to an improved ability to fight cancer or to withstand anticancer treatments is weak”.
NCCAM says of mistletoe
- More than 30 human studies using mistletoe to treat cancer have been done since the early 1960s, but major weaknesses in many of these have raised doubts about their findings (see Question 6).
- Very few bad side effects have been reported from the use of mistletoe extract, though mistletoe plants and berries are poisonous to humans (see Question 7).
- The U.S. Food and Drug Administration (FDA) has not approved mistletoe as a treatment for cancer or any other medical condition (see Question 8).
- The FDA does not allow injectable mistletoe to be imported, sold, or used except for clinical research (see Question 8).
Cochrane reviews lists several reviews of mistletoe with similar conclusions. For example “The evidence from RCTs to support the view that the application of mistletoe extracts has impact on survival or leads to an improved ability to fight cancer or to withstand anticancer treatments is weak”.
Anthroposophy is one of the highest grades of fantasy you can find. A post on that topic is in the works.
“Indicated for cancers . . . colon/rectal, uterine, breast, lung“. A cure for lung cancer? That, of course, depends on how you interpret the weasel words “indicated for”. Even Wikipedia makes no mention of any claims that Thuja benefits cancer. NHS Evidence (NeLCAM) doesn’t mention Thuja for any indication. Neither does NCCAM. Nor Cochrane reviews. That is not the impression the hapless students of this BSc lecture were given. In my view suggestions that you can cure lung cancer with this tree are just plain wicked.
Pure snake oil, and not even spelled correctly, Harry Hoxsey’s treatment centres in the USA were closed by court order in the 1950s.
At least this time it is stated that there is no hard evidence to support this brand of snake oil.
More unfounded claims when it says “treated successfully many cancer patients”. No references and no data to support the claim. It is utterly unfounded and claims to the contrary endanger the public.
Gerson therapy is one of the most notorious and unpleasant of the quack cancer treatments. The Gerson Institute is on San Diego, but their clinics are in Mexico and Hungary. It is illegal in the USA. According to the American Cancer Society you get “a strict low-salt, low-fat, vegetarian diet and drinking juice from about twenty pounds of fresh fruits and vegetables each day. One glass of juice is consumed each hour, thirteen times a day. In addition, patients are given several coffee enemas each day. Various supplements, such as potassium, vitamin B12, pancreatic enzymes, thyroid hormone, and liver extracts, are used to stimulate organ function, particularly of the liver and thyroid.”. At one time you also got several glasses of raw calf liver every day but after infections killed several people] carrot juice was given instead.
Cancer Research UK says “there is no evidence to show that Gerson therapy works as a cure for cancer”, and “The Gerson diet can cause some very serious side effects.” Nobody (except perhaps the Price of Wales) has any belief in this unpleasant, toxic and expensive folk-lore.
Again patients are endangered by teaching this sort of stuff.
And finally, the usual swipe at vaccines. It’s nothing to do with herbalism. but just about every alternative medicine advocate seems to subscribe to the anti-vaccination lobby.. It is almost as though they have an active preference for things that are known to be wrong. They seem to believe that medicine and science are part of an enormous conspiracy to kill everyone.
Perhaps this dangerous propaganda might have been ameliorated if the students had been shown this slide (from a talk by Melinda Wharton).
Click to enlarge
Left to people like this, we would still have smallpox, diphtheria. tetanus and rabies, Take a look at Vaccine-preventable diseases.
This is the sort of ‘education’ which the Pittilo report wants to make compulsory.
Smallpox in Baltimore, USA, 1939. This man was not vaccinated.
Conclusion
This selection of slides shows that much of the stuff taught in degrees in herbal medicine poses a real danger to public safety and to public health.
Pittilo’s idea that imposing this sort of miseducation will help safety is obviously and dangerously wrong. The Department of Health must reject the Pittilo recommendations on those grounds.
Follow-up
The Health Professions Council (HPC) is yet another regulatory quango.
The HPC’s strapline is
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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”.