Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
CHRE
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.”
The King’s Fund recently published Assessing complementary practice Building consensus on appropriate research methods [or download pdf].
It is described as being the “Report of an independent advisory group”. I guess everyone knows by now that an “expert report” can be produced to back any view whatsoever simply by choosing the right “experts”, so the first things one does is to see who wrote it. Here they are.
- Chair: Professor Dame Carol Black
- Harry Cayton, Chief Executive, Council for Healthcare Regulatory Excellence
- Professor Adrian Eddleston, then Vice-Chairman, The King’s Fund
- Professor George Lewith, Professor of Health Research, Complementary and Integrated Medicine Research Unit, University of Southampton
- Professor Stephen Holgate, MRC Clinical Professor of Immunopharmacology, University of Southampton
- Professor Richard Lilford, Head of School of Health and Population Sciences, University of Birmingham
We see at once two of the best known apologists for alternative medicine, George Lewith (who has appeared here more than once) and Stephen Holgate.
Harry Cayton is CEO of Council for Healthcare Regulatory Excellence (CHRE) which must be one of the most useless box-ticking quangos in existence. It was the CHRE that praised the General Chiropractic Council (GCC) for the quality of its work. That is the same GCC that is at present trying to cope with 600 or so complaints about the people it is supposed to regulate (not to mention a vast number of complaints to Trading Standards Offices). The GCC must be the prime example of the folly of giving government endorsement to things that don’t work. But the CHRE were not smart enough to spot that little problem. No doubt Mr Cayton did good work for the Alzheimer’s Society. His advocacy of patient’s choice may have helped me personally. But it isn’t obvious to me that he is the least qualified to express an opinion on research methods in anything whatsoever. According to the Guardian he is “BA in English and linguistics from the University of Ulster; diploma in anthropology from the University of Durham; B Phil in philosophy of education from the University of Newcastle.”
Adrian Eddlestone is a retired Professor of Medicine. He has been in academic administration since 1983. His sympathy for alternative medicine is demonstrated by the fact that he is also Chair of the General Osteopathic Council, yet another “regulator” that has done nothing to protect the public
from false health claims (and which may, soon, find itself in the same sort of trouble as the GCC).
Richard Lilford is the only member of the group who has no bias towards alternative medicine and also the only member with expertise in clinical research methods His credentials look impressive, and his publications show how he is the ideal person for this job. I rather liked also his article Stop meddling and let us get on.. He has written about the harm done by postmodernism and relativism, the fellow-travellers of alternative medicine.
Most damning of all, Lewith, Eddlestone and Holgate (along with Cyril Chantler, chair of the King’s Fund, and homeopaths, spiritual healers and Karol Sikora) are Foundation Fellows of the Prince of Wales Foundation for Magic Medicine, an organisation that is at the forefront of spreading medical misinformation.
I shall refer here to ‘alternative medicine’ rather than ‘complementary medicine’ which is used in the report. It is not right to refer to a treatment as ‘complementary’ until such time as it has been shown to work. The term ‘complementary’ is a euphemism that, like ‘integrative’, is standard among alternative medicine advocates whose greatest wish is to gain respectability.
The Report
The recommendations
On page 10 we find a summary of the conclusions.
The report identifies five areas of consensus, which together set a framework for moving forward. These are:
- the primary importance of controlled trials to assess clinical and cost effectiveness.
- the importance of understanding how an intervention works
- the value of placebo or non-specific effects
- the need for investment and collaboration in creating a sound evidence base
- the potential for whole-system evaluation to guide decision-making and subsequent research.
The first recommendation is just great. The rest sound to me like the usual excuses for incorporating ineffective treatments into medical practice. Notice the implicit assumption in the fourth point
that spending money on research will establish “a sound evidence base". There is a precedent, but it is ignored. A huge omission from the report is that it fails to mention anywhere that a lot of research has already been done.
Much research has already been done (and failed)
The report fails to mention at all the single most important fact in this area. The US National Institutes of Health has spent over a billion dollars on research on alternative medicines, over a period
of more than 10 years. It has failed to come up with any effective treatments whatsoever. See, for example Why the National Center for Complementary and Alternative Medicine (NCCAM) Should Be Defunded; Should there be more alternative research?; Integrative baloney @ Yale, and most recently, $2.5B Spent, No Alternative Med Cures found. .
Why did the committee think this irrelevant? I can’t imagine. You guess.
The report says
“This report outlines areas of potential consensus to guide research funders, researchers, commissioners and complementary practitioners in developing and applying a robust evidence base for complementary practice.”
As happens so often, there is implicit in this sentence the assumption that if you spend enough money evidence will emerge. That is precisely contrary to the experence in the USA where spending a billion dollars produced nothing beyond showing that a lot of things we already thought didn’t work were indeed ineffective.
And inevitably, and tragically, NICE’s biggest mistake is invoked.
“It is noteworthy that the evidence is now sufficiently robust for NICE to include acupuncture as a treatment for low back pain.” [p ]
Did the advisory group not read the evidence used (and misinterpeted) by NICE? It seems not. Did the advisory group not read the outcome of NIH-funded studies on acupuncture as summarised by Barker Bausell in his book, Snake Oil Science? Apparently not. It’s hard to know because the report has no references.
George Lewith is quoted [p. 15] as saying “to starve the system of more knowledge means we will continue to make bad decisions”. No doubt he’d like more money for research, but if a billion dollars
in the USA gets no useful result, is Lewith really likely to do better?
The usual weasel words of the alternative medicine industry are there in abundance
“First, complementary practice often encompasses an intervention (physical treatment or manipulation) as well as the context for that intervention. Context in this setting means both the physical setting for the delivery of care and the therapeutic relationship between practitioner and patient.” [p. 12]
Yes, but ALL medicine involves the context of the treatment. This is no different whether the medicine is alternative or real. The context (or placebo) effect comes as an extra bonus with any sort of treatment.
“We need to acknowledge that much of complementary practice seeks to integrate the positive aspects of placebo and that it needs to be viewed as an integral part of the treatment rather than an aspect that should be isolated and discounted.” [p. 13]
This is interesting. It comes very close (here and elsewhere) to admitting that all you get is a placebo effect, and that this doesn’t matter. This contradicts directly the first recommendation of the House of Lords report (2000).. Both the House of Lords report on Complementary and Alternative Medicine, and the Government’s response to it, state clearly
“. . . we recommend that three important questions should be addressed in the following order”. (1) does the treatment offer therapeutic benefits greater than placebo? (2) is the treatment safe? (3) how does it compare, in medical outcome and cost-effectiveness, with other forms of treatment?.
The crunch comes when the report gets to what we should pay for.
“Should we be prepared to pay for the so-called placebo effect?
The view of the advisory group is that it is appropriate to pay for true placebo (rather than regression to the mean or temporal effects).” [p 24]
Perhaps so, but there is very little discussion of the emormous ethical questions:that this opinion raises:
- How much is one allowed to lie to patients in order to elicit a placebo effect?
- Is is OK if the practitioner believes it is a placebo but gives it anyway?
- Is it OK if the pratitioner believes that it is not a placebo when actually it is?
- Is it OK for practitioners to go degrees taught by people who believe that it is not a placebo when actually it is?
The report fails to face frankly these dilemmas. The present rather absurd position in which it is considered unethical for a medical practitioner to give a patient a bottle of pink water, but
perfectly acceptable to refer them to a homeopath. There is no sign either of taking into account the cultural poison that is spread by telling people about yin, yang and meridians and such like preposterous made-up mumbo jumbo. That is part of the cost of endorsing placebos. And just when one thought that believing things because you wished they were true was going out of fashion
Once again we hear a lot about the alleged difficulties posed by research on alternative medicine. These alleged difficulties are, in my view, mostly no more than excuses. There isn’t the slightest
difficulty in testing things like herbal medicine or homeopathy, in a way that preserves all the ‘context’ and the ways of working of homeopaths and herbalists. Anyone who reads the Guardian knows
how to do that.
In the case of acupuncture, great ingenuity has gone into divising controls. The sham and the ‘real’ acupuncture always come out the same. In a non-blind comparison between acupuncture and no acupuncture the latter usually does a bit worse, but the effects are small and transient and entirely compatible with the view that it is a theatrical placebo.
Despite these shortcomings, some of the conclusions [p. 22] are reasonable.
“The public needs more robust evidence to make informed decisions about the use of complementary practice.
Commissioners of public health care need more robust evidence on which to base decisions about expenditure of public money on complementary practice.”
What the report fails to do is to follow this with the obvious conclusion that such evidence is largely missing and that until such time as it is forthcoming there should be no question of the NHS paying for alternative treatments.
Neither should there be any question of giving them official government recognition in the form of ‘statutory regulation’. The folly of doing that is illustrated graphically by the case of chiropractic which is now in deep crisis after inspection of its claims in the wake of the Simon Singh defamation case. Osteopathy will, I expect, suffer the same fate soon.
In the summary on p.12 we see a classical case of the tension
Controlled trials of effectiveness and cost-effectiveness are of primary importance
We recognise that it is the assessment of effectiveness that is of primary importance in reaching a judgement of different practices. Producing robust evidence that something works in practice – that it is effective – should not be held up by the inevitably partial findings and challenged interpretations arising from inquiries into how the intervention works.
The headline sounds impeccable, but directly below it we see a clear statement that we should use treatments before we know whether they work. “Effectiveness”, in the jargon of the alternative medicine business, simply means that uncontrolled trials are good enough. The bit about “how it works” is another very common red herring raised by alternative medicine people. Anyone who knows anything about pharmacology that knowledge about how any drug works is incomplete and often turns out to be wrong. That doesn’t matter a damn if it performs well in good double-blind randomised controlled trials.
One gets the impression that the whole thing would have been a lot worse without the dose of reality injected by Richard Lilford. He is quoted as a saying
“All the problems that you find in complementary medicine you will encounter in some other kind of treatment … when we stop and think about it… how different is it to any branch of health care – the answer to emerge from our debates is that it may only be a matter of degree.” [p. 17]
I take that to mean that alternative medicine poses problems that are no different from other sorts of treatment. They should be subjected to exactly the same criteria. If they fail (as is usually the case) they should be rejected. That is exactly right. The report was intended to produce consensus, but throughout the report, there is a scarcely hidden tension between believers on one side, and Richard Lilford’s impeccable logic on the other.
Who are the King’s Fund?
The King’s Fund is an organisation that states its aims thus.
“The King’s Fund creates and develops ideas that help shape policy, transform services and bring about behaviour change which improve health care.”
It bills this report on its home page as “New research methods needed to build evidence for the effectiveness of popular complementary therapies”. But in fact the report doesn’t really recommend ‘new research methods’ at all, just that the treatments pass the same tests as any other treatment. And note the term ‘build evidence’. It carries the suggestion that the evidence will be positive. Experience in the USA (and to a smaller extent in the UK) suggests that every time some good research is done, the effect is not to ‘build evidence’ but for the evidence to crumble further
If the advice is followed, and the results are largely negative, as has already happened in the USA, the Department of Health would look pretty silly if it had insisted on degrees and on statutory regulation.
The King’s Fund chairman is Sir Cyril Chantler and its Chief Executive is Niall Dickson. It produces reports, some of which are better than this one. I know it’s hard to take seriously an organisation that wants to “share its vision” withyou, but they are trying.
“The King’s Fund was formed in 1897 as an initiative of the then Prince of Wales to allow for the collection and distribution of funds in support of the hospitals of London. Its initial purpose was to raise money for London’s voluntary hospitals,”
It seems to me that the King’s Fund is far too much too influenced by the present Prince of Wales. He is, no doubt, well-meaning but he has become a major source of medical misinformation and his influence in the Department of Health is deeply unconstitutional. I was really surprised to see thet Cyril Chantler spoke at the 2009 conference of the Prince of Wales Foundation for Integrated Health, despite having a preview of the sort of make-believe being propagated by other speakers. His talk there struck me as evading all the essential points. Warm, woolly but in the end, a danger to patients. Not only did he uncritically fall for the spin on the word “integrated”, but he also fell for the idea that “statutory regulation” will safeguard patients.
Revelation of what is actually taught on degrees in these subjects shows very clearly that they endanger the public.
But the official mind doesn’t seem ever to look that far. It is happy ticking boxes and writing vacuous managerialese. It lacks curiosity.
Follow-up
The British Medical Journal published today an editorial which also recommends rebranding of ‘pragmatic’ trials. No surprise there, because the editorial is written by Hugh MacPherson, senior research fellow, David Peters, professor of integrated healthcare and Catherine Zollman, general practitioner. I find it a liitle odd that the BMJ says “Competing Interests: none. David Peters interest is obvious from his job description. It is less obvious that Hugh MacPherson is an acupuncture enthusiast who publishes mostly in alternative medicine journals. He has written a book with the extraordinary title “Acupuncture Research, Strategies for Establishing an Evidence Base”. The title seems to assume that the evidence base will materialise eventually despite a great deal of work that suggests it won’t. Catherine Zollman is a GP who is into homeopathy as well as acupuncture. All three authors were speakers at the Prince of Wales conference, described at Prince of Wales Foundation for magic medicine: spin on the meaning of ‘integrated’.
The comments that follow the editorial start with an excellent contribution from James Matthew May. His distinction between ‘caring’ and ‘curing’ clarifies beautifully the muddled thinking of the editorial.
Then a comment from DC, If your treatments can’t pass the test, the test must be wrong. It concludes
“At some point a stop has to be put to this continual special pleading. The financial crisis (caused by a quite different group of people who were equally prone to wishful thinking) seems quite a good time to start.”