Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
hot stone
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.”
I’m perfectly happy to think of alternative medicine as being a voluntary, self-imposed tax on the gullible (to paraphrase Goldacre again). But only as long as its practitioners do no harm and only as long as they obey the law of the land. Only too often, though, they do neither.
When I talk about law, I don’t mean lawsuits for defamation. Defamation suits are what homeopaths and chiropractors like to use to silence critics. heaven knows, I’ve becomes accustomed to being defamed by people who are, in my view. fraudsters, but lawsuits are not the way to deal with it.
I’m talking about the Trading Standards laws Everyone has to obey them, and in May 2008 the law changed in a way that puts the whole health fraud industry in jeopardy.
The gist of the matter is that it is now illegal to claim that a product will benefit your health if you can’t produce evidence to justify the claim.
I’m not a lawyer, but with the help of two lawyers and a trading standards officer I’ve attempted a summary. The machinery for enforcing the law does not yet work well, but when it does, there should be some very interesting cases.
The obvious targets are homeopaths who claim to cure malaria and AIDS, and traditional Chinese Medicine people who claim to cure cancer.
But there are some less obvious targets for prosecution too. Here is a selection of possibilities to savour..
- Universities such as Westminster, Central Lancashire and the rest, which promote the spreading of false health claims
- Hospitals, like the Royal London Homeopathic Hospital, that treat patients with mistletoe and marigold paste. Can they produce any real evidence that they work?
- Edexcel, which sets examinations in alternative medicine (and charges for them)
- Ofsted and the QCA which validate these exams
- Skills for Health and a whole maze of other unelected and unaccountable quangos which offer “national occupational standards” in everything from distant healing to hot stone therapy, thereby giving official sanction to all manner of treatments for which no plausible evidence can be offered.
- The Prince of Wales Foundation for Integrated Health, which notoriously offers health advice for which it cannot produce good evidence
- Perhaps even the Department of Health itself, which notoriously referred to “psychic surgery” as a profession, and which has consistently refused to refer dubious therapies to NICE for assessment.
The law, insofar as I’ve understood it, is probably such that only the first three or four of these have sufficient commercial elements for there to be any chance of a successful prosecution. That is something that will eventually have to be argued in court.
But lecanardnoir points out in his comment below that The Prince of Wales is intending to sell herbal concoctions, so perhaps he could end up in court too.
The laws
We are talking about The Consumer Protection from Unfair Trading Regulations 2008. The regulations came into force on 26 May 2008. The full regulations can be seen here, or download pdf file. They can be seen also on the UK Statute Law Database.
The Office of Fair Trading, and Department for Business, Enterprise & Regulatory Reform (BERR) published Guidance on the Consumer Protection from Unfair Trading Regulations 2008 (pdf file),
Statement of consumer protection enforcement principles (pdf file), and
The Consumer Protection from Unfair Trading Regulations: a basic guide for business (pdf file).
Has The UK Quietly Outlawed “Alternative” Medicine?
On 26 September 2008, Mondaq Business Briefing published this article by a Glasgow lawyer, Douglas McLachlan. (Oddly enough, this article was reproduced on the National Center for Homeopathy web site.)
“Proponents of the myriad of forms of alternative medicine argue that it is in some way “outside science” or that “science doesn’t understand why it works”. Critical thinking scientists disagree. The best available scientific data shows that alternative medicine simply doesn’t work, they say: studies repeatedly show that the effect of some of these alternative medical therapies is indistinguishable from the well documented, but very strange “placebo effect” ”
“Enter The Consumer Protection from Unfair Trading Regulations 2008(the “Regulations”). The Regulations came into force on 26 May 2008 to surprisingly little fanfare, despite the fact they represent the most extensive modernisation and simplification of the consumer protection framework for 20 years.”
The Regulations prohibit unfair commercial practices between traders and consumers through five prohibitions:-
- General Prohibition on Unfair Commercial
Practices (Regulation 3)- Prohibition on Misleading Actions (Regulations 5)
- Prohibition on Misleading Omissions (Regulation 6)
- Prohibition on Aggressive Commercial Practices (Regulation 7)
- Prohibition on 31 Specific Commercial Practices that are in all Circumstances Unfair (Schedule 1). 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 definition of “product” in the Regulations includes services, so it does appear that all forms medical products and treatments will be covered.
Just look at 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” |
Section 5 is equally powerful, and also does not contain the contentious word “cure” (see note below)
Misleading actions
5.—(1) A commercial practice is a misleading action if it satisfies the conditions in either paragraph (2) or paragraph (3).
(2) A commercial practice satisfies the conditions of this paragraph—
(a) if it contains false information and is therefore untruthful in relation to any of the matters in paragraph (4) or if it or its overall presentation in any way deceives or is likely to deceive the average consumer in relation to any of the matters in that paragraph, even if the information is factually correct; and
(b) it causes or is likely to cause the average consumer to take a transactional decision he would not have taken otherwise.
These laws are very powerful in principle, But there are two complications in practice.
One complication concerns the extent to which the onus has been moved on to the seller to prove the claims are true, rather than the accuser having to prove they are false. That is a lot more favourable to the accuser than before, but it’s complicated.
The other complication concerns enforcement of the new laws, and at the moment that is bad.
Who has to prove what?
That is still not entirely clear. McLachlan says
“If we accept that mainstream evidence based medicine is in some way accepted by mainstream science, and alternative medicine bears the “alternative” qualifier simply because it is not supported by mainstream science, then where does that leave a trader who seeks to refute any allegation that his claim is false?
Of course it is always open to the trader to show that his the alternative therapy actually works, but the weight of scientific evidence is likely to be against him.”
On the other hand, I’m advised by a Trading Standards Officer that “He doesn’t have to refute anything! The prosecution have to prove the claims are false”. This has been confirmed by another Trading Standards Officer who said
“It is not clear (though it seems to be) what difference is implied between “cure” and “treat”, or what evidence is required to demonstrate that such a cure is false “beyond reasonable doubt” in court. The regulations do not provide that the maker of claims must show that the claims are true, or set a standard indicating how such a proof may be shown.”
The main defence against prosecution seems to be the “Due diligence defence”, in paragraph 17.
Due diligence defence
17. —(1) In any proceedings against a person for an offence under regulation 9, 10, 11 or 12 it is a defence for that person to prove—
(a) that the commission of the offence was due to—
(i) a mistake;
(ii) reliance on information supplied to him by another person;
(iii) the act or default of another person;
(iv) an accident; or
(v) another cause beyond his control; and
(b) that he took all reasonable precautions and exercised all due diligence to avoid the commission of such an offence by himself or any person under his control.
If “taking all reasonable precautions” includes being aware of the lack of any good evidence that what you are selling is effective, then this defence should not be much use for most quacks.
Douglas McLachlan has clarified, below, this difficult question
False claims for health benefits of foods
A separate bit of legislation, European regulation on nutrition and health claims made on food, ref 1924/2006, in Article 6, seems clearer in specifying that the seller has to prove any claims they make.
Article 6
Scientific substantiation for claims
1. Nutrition and health claims shall be based on and substantiated by generally accepted scientific evidence.
2. A food business operator making a nutrition or health claim shall justify the use of the claim.
3. The competent authorities of the Member States may request a food business operator or a person placing a product on the market to produce all relevant elements and data establishing compliance with this Regulation.
That clearly places the onus on the seller to provide evidence for claims that are made, rather than the complainant having to ‘prove’ that the claims are false.
On the problem of “health foods” the two bits of legislation seem to overlap. Both have been discussed in “Trading regulations and health foods“, an editorial in the BMJ by M. E. J. Lean (Professor of Human Nutrition in Glasgow).
“It is already illegal under food labelling regulations (1996) to claim that food products can treat or prevent disease. However, huge numbers of such claims are still made, particularly for obesity ”
“The new regulations provide good legislation to protect vulnerable consumers from misleading “health food” claims. They now need to be enforced proactively to help direct doctors and consumers towards safe, cost effective, and evidence based management of diseases.”
In fact the European Food Standards Agency (EFSA) seems to be doing a rather good job at imposing the rules. This, predictably, provoked howls of anguish from the food industry There is a synopsis here.
“Of eight assessed claims, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected seven for failing to demonstrate causality between consumption of specific nutrients or foods and intended health benefits. EFSA has subsequently issued opinions on about 30 claims with seven drawing positive opinions.”
“. . . EFSA in disgust threw out 120 dossiers supposedly in support of nutrients seeking addition to the FSD’s positive list.
If EFSA was bewildered by the lack of data in the dossiers, it needn’t hav been as industry freely admitted it had in many cases submitted such hollow documents to temporarily keep nutrients on-market.”
Or, on another industry site, “EFSA’s harsh health claim regime”
“By setting an unworkably high standard for claims substantiation, EFSA is threatening R&D not to mention health claims that have long been officially approved in many jurisdictions.”
Here, of course,”unworkably high standard” just means real genuine evidence. How dare they ask for that!
Enforcement of the law
Article 19 of the Unfair Trading regulations says
19. —(1) It shall be the duty of every enforcement authority to enforce these Regulations.
(2) Where the enforcement authority is a local weights and measures authority the duty referred to in paragraph (1) shall apply to the enforcement of these Regulations within the authority’s area.
Nevertheless, enforcement is undoubtedly a weak point at the moment. The UK is obliged to enforce these laws, but at the moment it is not doing so effectively.
A letter in the BMJ from Rose & Garrow describes two complaints under the legislation in which it appears that a Trading Standards office failed to enforce the law. They comment
” . . . member states are obliged not only to enact it as national legislation but to enforce it. The evidence that the government has provided adequate resources for enforcement, in the form of staff and their proper training, is not convincing. The media, and especially the internet, are replete with false claims about health care, and sick people need protection. All EU citizens have the right to complain to the EU Commission if their government fails to provide that protection.”
This is not a good start. A lawyer has pointed out to me
“that it can sometimes be very difficult to get Trading Standards or the OFT to take an interest in something that they don’t fully understand. I think that if it doesn’t immediately leap out at them as being false (e.g “these pills cure all forms of cancer”) then it’s going to be extremely difficult. To be fair, neither Trading Standards nor the OFT were ever intended to be medical regulators and they have limited resources available to them. The new Regulations are a useful new weapon in the fight against quackery, but they are no substitute for proper regulation.”
Trading Standards originated in Weights and Measures. It was their job to check that your pint of beer was really a pint. Now they are being expected to judge medical controversies. Either they will need more people and more training, or responsibility for enforcement of the law should be transferred to some more appropriate agency (though one hesitates to suggest the MHRA after their recent pathetic performance in this area).
Who can be prosecuted?
Any “trader”, a person or a company. There is no need to have actually bought anything, and no need to have suffered actual harm. In fact there is no need for there to be a complainant at all. Trading standards officers can act on their own. But there must be a commercial element. It’s unlikely that simply preaching nonsense would be sufficient to get you prosecuted, so the Prince of Wales is, sadly, probably safe.
Universities who teach that “Amethysts emit high Yin energy” make an interesting case. They charge fees and in return they are “falsely claiming that a product is able to cure illnesses”.
In my view they are behaving illegally, but we shan’t know until a university is taken to court. Watch this space.
The fact remains that the UK is obliged to enforce the law and presumably it will do so eventually. When it does, alternative medicine will have to change very radically. If it were prevented from making false claims, there would be very little of it left apart from tea and sympathy
Follow-up
New Zealand must have similar laws.
Just as I was about to post this I found that in New Zealand a
“couple who sold homeopathic remedies claiming to cure bird flu, herpes and Sars (severe acute respiratory syndrome) have been convicted of breaching the Fair Trading Act.”
They were ordered to pay fines and court costs totalling $23,400.
A clarification form Douglas McLachlan
On the difficult question of who must prove what, Douglas McLachlan, who wrote Has The UK Quietly Outlawed “Alternative” Medicine?, has kindly sent the following clarification.
“I would agree that it is still for the prosecution to prove that the trader committed the offence beyond a reasonable doubt, and that burden of proof is always on the prosecution at the outset, but I think if a trader makes a claim regarding his product and best scientific evidence available indicates that that claim is false, then it will be on the trader to substantiate the claim in order to defend himself. How will the trader do so? Perhaps the trader might call witness after witness in court to provide anecdotal evidence of their experiences, or “experts” that support their claim – in which case it will be for the prosecution to explain the scientific method to the Judge and to convince the Judge that its Study evidence is to be preferred.
Unfortunately, once human personalities get involved things could get clouded – I could imagine a small time seller of snake oil having serious difficulty, but a well funded homeopathy company engaging smart lawyers to quote flawed studies and lead anecdotal evidence to muddy the waters just enough for a Judge to give the trader the benefit of the doubt. That seems to be what happens in the wider public debate, so it’s easy to envisage it happening a courtroom.”
The “average consumer”.
(3) A commercial practice is unfair if—
(a) it contravenes the requirements of professional diligence; and
(b) it materially distorts or is likely to materially distort the economic behaviour of the average consumer with regard to the product.
It seems,therefore, that what matters is whether the “average consumer” would infer from what is said that a claim was being made to cure a disease. The legal view cited by Mojo (comment #2, below) is that expressions such as “can be used to treat” or “can help with” would be considered by the average consumer as implying successful treatment or cure.
The drugstore detox delusion. A nice analysis “detox” at .Science-based Pharmacy
It may be only post-1992 universities that run degrees in nonsense, but you can find plenty even in the highest places. Like St Bartholomew’s (founded in 1123). That well known source of misleading medical advice, The Prince’s Foundation for Integrated Health (FiH), published last March, “Teaching integrated health at Barts and the London“. This consists of an interview with two members of staff from what is now known as the Barts and The London School of Medicine and Dentistry (SMD)..
| Dr Mark Carroll BSc (Hons), PhD, FHEA is Associate Dean (Education Quality) in the Centre for Medical Education (SMD), specialising in all aspects of quality assurance in the SMD |  |
| Prof Chris Fowler BSc MA MS FRCP FRCS(Urol) FEBU is Dean of Education |  |
They say they are dubious about alternative medicine, but rather keen on integrated medicine. Seems odd, since the latter is really just a euphemism for the former.
After seeing the FiH posting, I wrote to Carroll and Fowler to get more information.
From Carroll 20 March
We are at an early stage in the planning process for the “Integrated Health & Wellbeing” strand in our new MBBS curriculum. I can send you our ideas (attached). Much will depend on whether we can make a new appointment of someone who can lead on the planning
From Fowler 25 March 2008
Our discussions with the PFIH [Prince’s Foundation for Integrated Health] have only progressed to the stage of indicating an indicative curriculum for integrated health. We don’t have the sort of detail that you are asking for at present. We are hoping that they will work with us to get someone to champion the development.
. . .
Your views would be welcome
So I sent them some views on 26 March (read them here). I also said “I find it quite astonishing that a respectable medical school should feel it appropriate to have parts of its curriculum in the hands of the Prince of Wales.”. It seems, though, that only one sort of view was wanted. On 27 March. Fowler wrote
“I find your insinuation unnecessary and insulting. We have been working on a serious response to the GMC’s requirement that we teach medical students about the range of options available to patients. It is fatuous to suggest that the Prince of Wales is personally involved in any practical sense. The Prince’s Foundation for Integrated Health is an important stakeholder and I think that it entirely reasonable both to talk to them and to seek funding to help us to develop an area that is deficient in our current provision.”
Uhuh, not a very nice response to a rather moderate letter. Lesson 1: never trust anyone who uses the word “stakeholder”.
It does seem very odd that a medical school like Barts should turn to the Prince of Wales’ Foundation for advice on medicine. After all, the bad advice given by the “Patients Guide” is rather well documented (see also here). If messrs Fowler and Carroll were really unaware of that, I’d argue that they aren’t doing their job properly.
It seems that Barts, like Edinburgh, has over-reacted to pressure from the General Medical Council (GMC). Actually all that the GMC require is that
“They must be aware that many patients are interested in and choose to use a range of alternative and complementary therapies. Graduates must be aware of the existence and range of such therapies, why some patients use them, and how these might affect other types of treatment that patients are receiving.” (from Tomorrow’s Doctors, GMC)
There is nothing there about saying that they work. Certainly medical students need to be familiar with alternative medicine, given the number of theit patients that use it. That is a job I have done myself, both at UCL and at Kings College London. I’d argue that I am marginally better qualified to assess the evidence than the Prince of Wales.
Oddly enough, the bad education in Edinburgh came also from a Professor of Medical Education and Director of Undergraduate Learning and Teaching,
The result is manifested in two ways. Barts has a “Science in Medicine” course that has resulted in medical students being placed with homeopaths. And it has a Special Studies Module in Ayurvedic Medicine. Let’s take a look at them.
An Introduction to Ayurvedic Medicine
| The aims of this Special Study Module are “To introduce the concepts and principles which underpin Ayurvedic medicine. To introduce Year 1 and 2 medical students to the Ayurvedic approach to patient assessment, diagnosis and treatment”, and to “Critically evaluate the evidence base for Ayurvedic treatments and yoga therapy”. Just one small snag there. There is next to no evidence base to be assessed. |  Click to enlarge |
The module is given by Professor Shrikala Warrier, who is Dean of MAYUR: The Ayurvedic University of Europe. That sounds quite grand. But the web site of The Ayurvedic University of Europe is rather unusual for a university. It lists two courses but has no list of staff. Could it be that Professor Shrikala Warrier is the staff? Neither is it clear where Professor Warrier’s professorial title comes from. Her own private university perhaps?
The two courses it offers are B.Sc.(Hons) Ayurveda and B.Sc.(Hons) Yoga. It says that the course the “BA(Hons)Ayurvedic Studies is a three year programme of study developed in collaboration with Thames Valley University in London”. That’s odd too, because there is no mention of it on the Thames Valley University web site (and TVU is not in London, it’s in Slough). Elsewhere it is stated that the “programme has been validated by MAHE, which is also the degree awarding body”. MAHE is not explained but it appears to refer to the Manipal Academy of Higher Education, in Goa, India. That looks like a pretty good place. It does not offer degrees in Ayurveda, though there is a small Department of Ayurvedic medicine within the otherwise entirely conventional Kasturba Medical College-Manipal. Their first year physiology exam would tax our students.
Elsewhere we see the same address, 81 Wimpole Street, listed as The Manipal Ayurvedic University of Europe (a joint venture between The Manipal University and the Ayurvedic Company of Great Britain) Prof. S. Warrier, B.A.(Hons), M.A., Ph.D., MILT, Dean of Academic Planning.
If one checks Mayur Ltd at Companies House, one finds that it has two directors, Lady Sarah Morritt and Professor Shrikala Warrier. The company report shows that no accounts have been filed up to now and their 2008 accounts are overdue.
The business history of ayurveda is nothing if not tortuous. The London Gazette (May 2008) notifies us that
AYURVEDA HOLDINGS LIMITED (chairman Lady Sarah Morritt) was passed a Special Resolution: “That the company be wound up voluntarily.”
If you email the Ayurvedic University of Europe, the reply comes not from a University address but from unififiedherbal.com. That seems to be some sort of marketing company, at the same address, 81 Wimpole Street. But efforts to find out more about it from Companies House show that UnifiedHerbal.com was dissolved on 3 October 2006.
Several of the links are broken on the web site of Ayurvedic University of Europe, but one that does work is ‘products’. That takes you to the sales pages of http://www.drwarrier.co.uk/. That doesn’t look much like a university, but no prizes for guessing the address. Yes, it’s 81 Wimpole Street again. They will sell you all sorts of cosmetics, though Companies House lists Dr Warrier Limited, and tells us
Last Accounts Made Up To : 31/08/2007 (DORMANT) and
Next Return Due : 26/09/2008 OVERDUE. Their registered office is
at Harold House, Waltham Cross EN8 7AF.
From drwarrier.co.uk you can buy, for example,
The most commonly prescribed Ayurvedic formula. Triphala is an effective blood purifier that detoxifies the liver, helps digestion and assimilation, and reduces serum cholesterol and lipid levels.
Blood purifier? Detox? Where have we seen this sort of utter gobbledygook before? Or perhaps she can sell you some
Traditionally used for obesity and overweight, and reducing and preventing accumulation of cholesterol (LDL). Its anti-inflammatory and detoxifying actions help reduce arthritic pain and swelling.
There isn’t the slightest evidence for these effects in man. Hence, no doubt, the usual weasel words. “traditionally used for . . . ”
The sales department alone casts rather a large doubt on Prof Warrier’s ability to teach medical students how to “critically evaluate the evidence base for Ayurvedic treatments”.
It does seem a bit surprising that a top flight medical school should think that this is an appropriate place to educate its students.
Medicine in Society
The syllabus at Barts includes something called Medicine and Society. Page 5 of the second year Tutor Guide mentions “complementary therapies” as part of the course. There is little hint about what that means in practice.
It turns out that the alt med placements are at the Greenwich Natural Health Centre. Nothing is too barmy for them Acupuncture. Cranial Osteopathy, Craniosacral Therapy, Herbal Therapy, Homeopathy, Hot Stone Therapy and Nutritional therapy to name but a few of the preposterous make-believe stuff that is on offer.
Medical students are having to spend their time listing to stuff like this, on ‘hot stone therapy’.
“Hot stone therapy / massage is a kind of massage that uses treated volcanic rocks such as basalt and basinite that are believed to promote relaxation as well as eliminating negative energy within the client’s body, mind and soul.”
“These stones are carefully gathered and handcrafted for various sizes, shapes and weights according to what part of the body it will be use on.”
Or this, on ‘nutritional therapy’.
“Many of us lack the basic raw materials (from food and drink) to function at our best. Intensive farming, pollution, stress, stimulants and an over-reliance on processed foods are just some of the reasons for us being deficient in vital nutrients. As a result, we may develop serious degenerative diseases like cancer or arthritis.”
“Some clients may experience reactions like headaches, skin eruptions or bad breath during the first stage of treatment. These are quite normal and are due to detoxification, which is usually followed by a sense of well-being and increased energy.”
That must be about as close as you can get to claiming you can prevent cancer by taking vitamin pills. It is wrong and it is dangerous,
Sigh. What century are we living in?
According to Barts’ second year Tutor Guide, “Placement tutors are responsible for student assessment”.
What sort of grade will the student get if they tell their tutor in homeopathy or ‘Nutritional therapy’ that they are talking nonsense?
What do the students think?
Could the Ayurvedic course be the very same course that is referred to by a second year medical student on the Unprotected Text blog?
“When I found out my friend had been attached to a “doctor” in Ayurvedic “medicine” for the year I was horrified, as was she, and the school would not allow her to change claiming that the point is not to learn the medicine but its role in the multidisciplinary healthcare team.
I don’t believe that there is such a role.
The very fact that a student is forced to put up with this as a part of their education is appalling.”
A comment left on Unprotected Text by someone writing as ‘Barts Medic’ said
“I was HORRIFIED to hear that some of my friends have their medsoc placements
at such RUBBISH places too!last week, they were forced into a room one by room to be touched up (‘massaged’)
by the ‘doctor-person’ to HEAL them. she rubbed them all over, and CHANTED! WTF.if i was given a CRAPPY placement like that, i wouldnt turn up either”.
And there is an excellent statement about “holistic medicine” on Unprotected Text. Better, perhaps, than you’d get from the GMC.
“Holistic medicine is in fact a world away from homeopathy, although the two are often confused predominantly by homeopaths trying to validate their branch of “medicine”. Much of what is taught in medical school is in fact, holistic, and so it should be. The importance of mentality, or spirituality in medicine should not be used to excuse homeopathy.”
“That doesn’t seem to add up” is another blog that relates the experiences of another student who has been exposed to “Enforced quackery Day 1, “, “Enforced quackery Day 2“, “Enforced quackery Days 3 and 4“. He says
“. . .by the end of day 3 the students *still* hadn’t seen any patients and that, when confronted with this fact the person in charge is reported to have said that this was because she was scared of what the students might say to the patients… Apart from this being a massive insult to the professionalism of the students, it is at least an encouraging sign that they have not been very effectively indoctrinated.”
It seems that we shall soon have some more documentary evidence. It is truly impressive to find that Barts’ medical students are so bright and that they have the courage to speak up about it.
So there is one good thing. We have some very perspicacious medical students in London.
Pity that one can’t say the same thing of their teachers.
Follow-up
I have it on good authority that the unhappy students who were placed at the Greenwich Natural Health Centre were presented with one of the more absurd documents ever to be produced by homeopaths, “An Overview of positive homeopathy research and surveys“.
There is no need to argue about whether homeopaths cherry-pick the evidence. The selective use of evidence is announced proudly, right there in the title.
What excuse can Bart’s have for exposing medical students to such profoundly anti-educational stuff as this?
Later there appeared on the That doesn’t seem to add up blog, Enforced
Quackery – the literature. The unfortunate students who were pushed into a homeopathic placement were give a print out of a page from Sue Young’s homeopathic web site. It is merely a bit of phony history that attempts to link Pasteur with homeopathy.
Sue Young, incidentally, is a homeopath who has consistently breached the Code of Ethicsof the Society of Homeopaths by claiming to treat serious diseases, though needless to say the Society did nothing about it. She is also the person who wrote a wholly inaccurate account of the reasons why my blog left the UCL server (see alse here and here). She didn’t, needless to say, ask me, but luckily she was soon corrected on quackometer and in the Guardian.
Incidentally, the Unprotected Text blog continues to provide a fascinating student view on medical education. Students show more sense than their teachers not only about alternative nonsense but also about other gimmicks like ‘problem based learning’.