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

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

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

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

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

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

Chinese medicine -acupuncture gobbledygook revealed

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

Why degrees in Chinese medicine are a danger to patients

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

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

The submission

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

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

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

The questionnaire

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

Harm

No Harm

Unsure

Comment

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

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

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

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

Yes

No

Unsure

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

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

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

Significant benefit

Some benefit

No benefit

Unsure

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

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

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

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

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

Justified

Not Justified

Unsure

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

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

Yes

No

Unsure

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

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

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

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

Significant effect

Some effect

No effect

Unsure

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

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

Voluntary self-regulation

Accreditation of voluntary bodies

Statutory or voluntary licensing

Unsure

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

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

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

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

Acupuncture

Herbal Medicine

TCM

Unsure

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

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

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

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

Yes

No

Unsure

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

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

Yes

No

Unsure

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

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

Yes

No

Unsure

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

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

HPC

GPC/PSNI

Unsure

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

Q16: If neither, who should and why?

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

Q17:

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

Yes

No

Unsure

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

Yes

No

Unsure

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

(b) Yes

Q18.

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

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

Yes

No

Unsure

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

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

Yes

No

Unsure

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

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

Yes

No

Unsure

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

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

Yes

No

Unsure

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

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

Significant impact

Some impact

No impact

Unsure

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

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

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

Jump to follow-up

The Prince of Wales’ Foundation for Integrated Health (FiH) is a propaganda organisation that aims to persuade people, and politicians, that the Prince’s somewhat bizarre views about alternative medicine should form the basis of government health policy.

His attempts are often successful, but they are regarded by many people as being clearly unconstitutional.



The FiH’s 2009 AnnualConferen ce conference was held at The King’s Fund, London 13 – 14 May 2009. It was, as always, an almost totally one-sided affair devoted to misrepresentation of evidence and the promotion of magic medicine.  But according to the FiH, at least, it was a great success.  The opening speech by the Quacktitioner Royal can be read here. It has already been analysed by somebody who knows rather more about medicine than HRH.    He concludes

“It is a shocking perversion of the real issues driven by one man; unelected, unqualified and utterly misguided”.

We are promised some movie clips of the meeting. They might even make a nice UK equivalent of “Integrative baloney @ Yale“.

This post is intended to provide some background information about the speakers at the symposium. But let’s start with what seems to me to be the real problem. The duplicitous use of the word “integrated” to mean two quite different things.

The problem of euphemisms: spin and obfuscation

One of the problems of meetings like this is the harm done by use of euphemisms.   After looking at the programme, it becomes obvious that there is a rather ingenious bit of PR trickery going on.  It confuses (purposely?) the many different definitions of the word “integrative”  . One definition of “Integrative medicine” is this (my emphasis).

” . . . orienting the health care process to engage patients and caregivers in the full range of physical, psychological, social, preventive, and therapeutic factors known to be effective and necessary for the achievement of optimal health.”

That is a thoroughly admirable aim. And that, I imagine, is the sense in which several of the speakers (Marmot, Chantler etc) used the term.  Of course the definition is rather too vague to be very helpful in practice, but nobody would dream of objecting to it.

But another definition of the same term ‘integrative medicine’ is as a PR-friendly synonym for ‘alternative medicine’, and that is clearly the sense in which it is used by the Prince of Wales’ Foundation for Integrated Health (FIH), as is immediately obvious from their web site.
The guide to the main therapies supports everything from homeopathy to chiropractic to naturopathy, in a totally uncritical way. Integrated service refers explicitly to integration of ‘complementary’ medicine, and that itself is largely a euphemism for alternative medicine. For example, the FIH’s guide to homeopathy says

“What is homeopathy commonly used for?

Homeopathy is most often used to treat chronic conditions such as asthma; eczema; arthritis; fatigue disorders like ME; headache and migraine; menstrual and menopausal problems; irritable bowel syndrome; Crohn’s disease; allergies; repeated ear, nose, throat and chest infections or urine infections; depression and anxiety.”

But there is not a word about the evidence, and perhaps that isn’t surprising because the evidence that it works in any of these conditions is essentially zero.

The FIH document Complementary Health Care: A Guide for Patients appears to have vanished from the web after its inaccuracy received a very bad press, e.g. in the Times, and also here.   It is also interesting that the equally widely criticised Smallwood report (also sponsored by the Prince of Wales) seems to have vanished too).

The programme for the meeting can be seen here, for Day 1, and Day 2

Conference chair Dr Phil Hammond, GP, comedian and health service writer. Hammond asked the FIH if I could speak at the meeting to provide a bit of balance. Guess what? They didn’t want balance.

09:30 Opening session

Dr Michael Dixon OBE

09:30   Introduction: a new direction for The Prince’s Foundation for Integrated Health and new opportunities in integrated health and care. Dr Michael Dixon, Medical Director, FIH

Michael Dixon is devoted to just about every form of alternative medicine. As well as being medical director of the Prince’s Foundation he also runs the NHS Alliance. Despite its name, the NHS Alliance is nothing to do with the NHS and acts, among other things, as an advocate of alternative medicine on the NHS, about which it has published a lot.

Dr Dixon is also a GP at College Surgery, Cullompton, Devon, where his “integrated practice” includes dozens of alternative practitioners. They include not only disproven things like homeopathy and acupuncture, but also even more bizarre practitioners in ‘Thought Field Therapy‘ and ‘Frequencies of Brilliance‘.

To take only one of these, ‘Frequencies of Brilliance’ is bizarre beyond belief. One need only quote its founder and chief salesperson.

“Frequencies of Brilliance is a unique energy healing technique that involves the activation of energetic doorways on both the front and back of the body.”

“These doorways are opened through a series of light touches. This activation introduces high-level Frequencies into the emotional and physical bodies.  It works within all the cells and with the entire nervous system which activates new areas of the brain.”

Or here one reads

“Frequencies of Brilliance is a 4th /5th dimensional work.   The process is that of activating doorways by lightly touching the body or working just above the body.”

“Each doorway holds the highest aspect of the human being and is complete in itself. This means that there is a perfect potential to be accessed and activated throughout the doorways in the body.”

Best of all, it can all be done at a distance (that must help sales a lot). One is reminded of the Skills for Health “competence” in distant healing (inserted on a government web site at the behest (you guessed it) of the Prince’s Foundation, as related here)

“The intent of a long distance Frequencies of Brilliance (FOB) session is to enable a practitioner to facilitate a session in one geographical location while the client is in another.

A practitioner of FOB that has successfully completed a Stage 5 Frequency workshop has the ability to create and hold a stable energetic space in order to work with a person that is not physically present in the same room.

The space that is consciously created in the Frequencies of Brilliance work is known as the “Gap”. It is a space of nonlinear time. It contains ”no time and no space” or  respectively “all time and all space”. Within this “Gap” a clear transfer of the energies takes place and is transmitted to an individual at a time and location consciously intended. Since this dimensional space is in non-linear time the work can be performed and sent backward or forward in time as well as to any location.

The Frequencies of Brilliance work cuts through the limitations of our physical existence and allows us to experience ourselves in other dimensional spaces. Therefore people living in other geographic locations than a practitioner have an opportunity to receive and experience the work.

The awareness of this dimensional space is spoken about in many indigenous traditions, meditation practices, and in the world of quantum physics. It is referred to by other names such as the void, or vacuum space, etc.”

This is, of course, preposterous gobbledygook.  It, and other things in Dr Dixon’s treatment guide, seem to be very curious things to impose on patients in the 21st century.

Latest news.  The Mid-Devon Star announces yet more homeopathy in Dr Dixon’s Cullompton practice.  This time it comes in the form of a clinic run from the Bristol Homeopathic Hospital.  I guess they must be suffering from reduced commissioning like all the other homeopathic hospitals, but Dr Dixon seems to have come to their rescue. The connection seems to be with Bristol’s homeopathic consultant, Dr Elizabeth A Thompson.   On 11 December 2007 I wrote to Dr Thompson, thus

In March 2006, a press release http://www.ubht.nhs.uk/press/view.asp?257 announced a randomised trial for homeopathic treatment of asthma in children.

This was reported also on the BBC http://news.bbc.co.uk/1/hi/england/bristol/4971050.stm .

I’d be very grateful if you could let me know when results from this trial will become available.

Yours sincerely

David Colquhoun


The reply, dated 11 December 2007, was unsympathetic

I have just submitted the funders report today and we have set ourselves the deadline to publish two inter-related papers by March 1st 2007.

Can I ask why you are asking and what authority you have to gain this information. I shall expect a reply to my questions,

I answered this question politely on the same day but nevertheless my innocent enquiry drew forth a rather vitriolic complaint from Dr Thompson to the Provost of UCL (dated 14 December 2007).  In this case, the Provost came up trumps. On 14 January 2008 he replied to Thompson: “I have looked at the email that you copied to me, and I must say that it seems an entirely proper and reasonable request. It is not clear to me why Professor Colquhoun should require some special authority to make such direct enquiries”.  Dr Thompson seems to be very sensitive. We have yet to see the results of her trial in which I’m still interested.

Not surprisingly, Dr Dixon has had some severe criticism for his views, not least from the UK’s foremost expert on the evidence for efficacy,  Prof Edzard Ernst.   Accounts of this can be found in Pulse,
and on Andrew Lewis’s blog.

Dixon is now (in)famous in the USA too.  The excellent Yale neurologist,  Steven Novella, has written an analysis of his views on Science Based Medicine. He  describes Dr. Michael Dixon as  “A Pyromaniac In a Field of (Integrative) Straw Men

Peter Hain

09:40 Politics and people: can integrated health and care take centre stage in 2009/2010? Rt Hon Peter Hain MP

It seems that Peter Hain was converted to alternative medicine when his first baby, Sam, was born with eczema. After (though possibly not because of) homeopathic treatment and a change in diet, the eczema got better. This caused Hain, while Northern Ireland Secretary to spend £200,000 of taxpayers’ money to set up a totally uninformative customer satisfaction survey, which is being touted elsewhere in this meeting as though it were evidence (see below). I have written about this episode before:  see Peter Hain and Get Well UK: pseudoscience and privatisation in Northern Ireland.

I find it very sad that a hero of my youth (for his work in the anti-apartheid movement) should have sunk to promoting junk science, and even sadder that he does so at my expense.

There has been a report on Hain’s contribution in Wales Online.

09:55 Why does the Health Service need a new perspective on health and healing? Sir Cyril Chantler, Chair, King’s Fund, previous Dean, Guy’s Hospital and Great Ormond Street

Cyril Chantler is a distinguished medical administrator. He also likes to talk and we have discussed the quackery problem several times. He kindly sent me the slides that he used.   Slide 18 says that in order to do some good we “need to demonstrate that the treatment is clinically effective and cost effective for NHS use”.  That’s impeccable, but throughout the rest of the slides he talks of integrating with  complementary” therapies, the effectiveness of which is either already disproved or simply not known.

I remain utterly baffled by the reluctance of some quite sensible people to grasp the nettle of deciding what works. Chantler fails to grasp the nettle, as does the Department of Health. Until they do so, I don’t see how they can be taken seriously.

10.05 Panel discussion

The Awards

10:20 Integrated Health Awards 2009 Introduction: a review of the short-listed applications

10:45 Presentations to the Award winners by the special guest speaker

11:00 Keynote address by special guest speaker

Getting integrated

Dr David Peters

12:00 Integration, long term disease and creating a sustainable NHS. Professor David Peters, Clinical Director and Professor of Integrated Healthcare, University of Westminster

I first met David Peters after Nature ran my article, Science Degrees without the Science. .One of the many media follow-ups of that article was on Material World (BBC Radio 4). This excellent science programme, presented by Quentin Cooper, had a discussion between me and David Peters ( listen to the mp3 file).


There was helpful intervention from Michael Marmot who had talked, in the first half of the programme, about his longitudinal population studies.

Marmot stressed the need for proper testing.  In the case of
homeopathy and acupuncture, that proper testing has largely been done.  The tests were failed.

The University of Westminster has, of course, gained considerable notoriety as the university that runs more degree programmes in anti-scientific forms of medicine than any other.  Their lecture on vibrational medicine teaches students that amethysts “emit high Yin energy so transmuting lower energies and clearing and aligning energy disturbances at all levels of being”.   So far their vice-chancellor, Professor Geoffrey Petts, has declined to answer enquiries about whether he thinks such gobbledygook is appropriate for a BSc degree.

But he did set up an internal enquiry into the future of their alternative activities. Sadly that enquiry seems to have come to the nonsensical conclusion that the problem can be solved by injection of good science into the courses, as reported here and in the Guardian.
It seems obvious that if you inject good science into their BSc in homeopathy the subject will simply vanish in a puff of smoke.

In 2007, the University of Westminster did respond to earlier criticism in Times Higher Education, but their response seemed to me to serve only to dig themselves deeper into a hole.

Nevertheless, Westminster has now closed down its homeopathy degree (the last in the country to go) and there is intense internal discussion going on there. I have the impression that Dr Peters’ job is in danger.  The revelation of more slides from their courses on homeopathy, naturopathy and Chinese herbal medicine shows that these courses are not only barmy, but also sometimes dangerous.

Professor Chris Fowler

12:10 Educating tomorrow’s integrated doctors. Professor Chris Fowler, Dean for Education, Barts and The London School of Medicine and Dentistry

I first came across Dr Fowler when I noticed him being praised for his teaching of alternative medicine to students at Barts and the London Medical School on the web site of the Prince’s Foundation. I wrote him a polite letter to ask if he really thought that the Prince of Wales was the right person to consult about the education of medical students.  The response I got was, ahem, unsympathetic. But a little while later I noticed that two different Barts students had set up public blogs that criticised strongly the nonsense that was being inflicted on them.

At that point, I felt it was necessary to support the students who, it seemed to me, knew more about medical education than Professor Fowler. It didn’t take long to uncover the nonsense that was being inflicted on the students: read about it here.

There is a follow-up to this story here.  Fortunately, Barts’ Director of Research, and, I’m told, the Warden of Barts, appear to agree with my view of the harm that this sort of thing can do to the reputation of Barts, so things may change soon,

Dame Donna Kinnair

12:30 Educating tomorrow’s integrated nurses.
Dame Donna Kinnair, Director of Nursing, Southwark PCT

As far as I can see, Donna Kinnair has no interest in alternative medicine. She is director of nursing at Southwark primary care trust and was an adviser to Lord Laming throughout his inquiry into the death of Victoria Climbié.  I  suspect that her interest is in integrating child care services (they need it, judging by the recent death of ‘Baby P’).  Perhaps her presence shows the danger of using euphemisms like ‘integrated medicine’ when what you really mean is the introduction of unproven or disproved forms of medicine.

Michael Dooley

12:40 Integrating the care of women: an example of the new paradigm. Michael Dooley, Consultant Obstetrician and Gynecologist

DC’s rule 2. Never trust anyone who uses the word ‘paradigm’.   It is a sure-fire sign of pseudoscience.  In this case, the ‘new paradigm’ seems to be the introduction of disproven treatment.  Dooley is a gynaecologist and Medical Director of the Poundbury Clinic.  His clinic offers a whole range of unproven and disproved treatments.  These include acupuncture  as an aid to conception in IVF. This is not recommended by the Cochrane review, and one report suggests that it hinders conception rather than helps.

12.40   Discussion

13.00 – 14.00  Lunch and Exhibition

15.30    Tea

Boo Armstrong and Get Well UK

16.00   Integrated services in action: The Northern
Ireland experience: what has it shown us and what are its implications?
Boo Armstrong of Get Well UK with a team from the NI study

I expect that much will be made of this “study”, which, of course, tells you absolutely nothing whatsoever about the effectiveness of the alternative treatments that were used in it. This does not appear to be the view of Boo Armstrong,   On the basis of the “study”, her company’s web site proclaims boldly

“Complementary Medicine Works

Get Well UK ran the first government-backed complementary therapy project in the UK, from February 2007 to February 2008″

This claim appears, prima facie, to breach the Unfair Trading Regulations of May 2008.   The legality of the claim is, at the moment, being judged by a Trading Standards Officer.  In any case, the “study” was not backed by the government as a whole, but just by Peter Hain’s office.  It is not even clear that it had ethical approval.

The study consisted merely of asking people who had seen an alternative medicine practitioner whether they felt better or worse.  There was no control group; no sort of comparison was made.  It is surely obvious to the most naive person that a study like this cannot even tell you if the treatment has a placebo effect, never mind that it has any genuine effects of its own.  To claim that it does so seems to be simply dishonest.  There is no reason at all to think that the patients would not have got better anyway.

It is not only Get Well UK who misrepresent the evidence.  The Prince’s
Foundation itself
says

“Now a new, year long trial supported by the Northern Ireland health service has . . . demonstrated that integrating complementary and conventional medicine brings measurable benefits to patients’ health.”

That is simply not true. It is either dishonest or stupid. Don’t ask me which, I have no idea.

This study is no more informative than the infamous Spence (2005) ‘study’ of the same type, which seems to be the only thing that homeopaths can produce to support their case.

There is an excellent analysis of the Northern Ireland ‘study’ by Andy Lewis, The Northern Ireland NHS Alternative Medicine ‘Trial’.  He explains patiently, yet again, what constitutes evidence and why studies like this are useless.

His analogy starts

” . . . the Apple Marketing Board approach the NHS and ask for £200,000 to do a study to show the truth behind the statement ‘An apple a day keeps the doctor away’. The Minister, being particularly fond of apples, agrees and the study begins.”

16.30 Social enterprise and whole systems integrated care.  Dee Kyne, Sandwell PCT and a GP.  Developing an integrated service in secondary care

Dee Kyne appears to be CEO of KeepmWell Ltd (a financial interest that is not mentioned).

Peter Mackereth, Clinical Lead, Supportive Services, Christie Hospital NHS Foundation Trust

I had some correspondence with Mackereth when the Times (7 Feb 2007) published a picture of the Prince of Wales inspecting an “anti-MRSA aromatherapy inhaler” in his department at the Christie. It turned out that the trial they were doing was not blind   No result has been announced anyway, and on enquiry, I find that the trial has not even started yet.  Surprising, then to find that the FIH is running the First Clinical Aromatherapy Conference at the Christie Hospital,  What will there be to talk about?

Much of what they do at the Christie is straightforward massage, but they also promote the nonsensical principles of “reflexology” and acupuncture.

The former is untested.  The latter is disproven.

Parallel Sessions

Developing a PCT funded musculoskeletal service Dr Roy Welford, Glastonbury Health Centre

Roy Welford is a Fellow of the Faculty of Homeopathy, and so promotes disproven therapies. The Glastonbury practice also advertises acupuncture (disproven), osteopathy and herbal medicine (largely untested so most of it consists of giving patients an unknown dose of an ill-defined drug, of unknown effectiveness and unknown safety).

Making the best of herbal self-prescription in integrated practice: key remedies and principles. Simon Mills, Project Lead: Integrated Self Care in Family Practice, Culm Valley Integrated Centre for Health, Devon

Simon Mills is a herbalist who now describes himself as a “phytotherapist” (it sounds posher, but the evidence, or lack of it, is not changed by the fancy name). Mills likes to say things like “there are herbs for heating and drying”, “hot and cold” remedies, and to use meaningless terms like “blood cleanser”, but he appears to be immune to the need for good evidence that herbs work before you give them to sick people. He says, at the end of a talk, “The hot and the cold remain the trade secret of traditional medicine”.  And this is the 21st Century.

Practical ways in which complementary approaches can improve the treatment of cancer. Professor Jane Plant, Author of “Your life in your hands” and Chief Scientist, British Geological Society and Professor Karol Sikora, Medical Director, Cancer Partners UK

Jane Plant is a geologist who, through her own unfortunate encounter with breast cancer, became obsessed with the idea that a dairy-free diet cured her.  Sadly there is no good evidence for that idea, according to the World Cancer Research Fund Report, led by Professor Sir Michael Marmot.   No doubt her book on the subject sells well, but it could be held that it is irresponsible to hold out false hopes to desperate people.   She is a supporter of the very dubious CancerActive organisation (also supported by Michael Dixon OBE –see above) as well as the notorious pill salesman, Patrick Holford (see also here).

Karol Sikora, formerly an oncologist at the Hammersmith Hospital, is now Dean of Medicine at the University of Buckingham (the UK’s only private university).  He is also medical director at CancerPartners UK, a private cancer company.

He recently shot to fame when he appeared in a commercial in the USA sponsored by “Conservatives for Patients’ Rights”, to pour scorn on the NHS, and to act as an advocate for the USA’s present health system. A very curious performance.  Very curious indeed.

His attitude to quackery is a mystery wrapped in an enigma.  One was somewhat alarmed to see him sponsoring a course at what was, at first, called the British College of Integrated Medicine, and has now been renamed the Faculty of Integrated Medicine That grand title makes it sound like part of a university.  It isn’t.




The alarm was as result of the alliance with Dr Rosy Daniel (who promotes an untested herbal conconction, Carctol, for ‘healing’ cancer) and Dr Mark Atkinson (a supplement salesman who has also promoted the Qlink pendant.  The Qlink pendant is a simple and obvious fraud designed to exploit paranoia about WiFi killing you.

The first list of speakers on the proposed diploma in Integrated Medicine was an unholy alliance of outright quacks and commercial interests.  It turned out that, although Karol Sikora is sponsoring the course, he knew nothing about the speakers.  I did and when I pointed this out to Terence Kealey, vice-chancellor of Buckingham, he immediately removed Rosy Daniel from directing the Diploma.  At the moment the course is being revamped entirely by Andrew Miles.  There is hope that he’ll do a better job.  It has not yet been validated by the University of Buckingham. Watch this space for developments.

Stop press It is reported in the Guardian that Professor Sikora has been describing his previous job at Imperial College with less than perfect accuracy. Oh dear. More developments in the follow-up.

The role of happy chickens in healing: farms as producers of health as well as food – the Care Farm Initiative Jonathan Dover, Project Manager, Care Farming, West Midlands.

Apparently,

“Care farming is a partnership between farmers, participants and health & social care providers. It combines the care of the land with the care of people, reconnecting people with nature and their communities.”

Sounds lovely, I wonder how well it works?

What can the Brits learn from the Yanks when it comes to integrated health? Jack Lord, Chief Executive Humana Europe

It is worth noticing that the advisory board of Humana Europe includes Micheal Dixon OBE, a well known advocate of alternative medicine (see
above
).  Humana Europe is a private company, a wholly owned subsidiary of Humana Inc., a health benefits company with 11 million members and 22,000 employees and headquarters in Louisville, Kentucky.  In 2005 it entered into a business partnership with Virgin Group. Humana was mentioned in the BBC Panorama programme “NHS for Sale”. The company later asked that it be pointed out that they provide commissioning services, not clinical services [Ed. well not yet anyway].

Humana’s document “Humana uses computer games to help people lead healthier lives” is decidedly bizarre.  Hang on, it was only a moment ago that we were being told that computer games rewired your brain.

Day 2 Integrated health in action

09.00 Health, epidemics and the search for new solutions. Sir Michael Marmot, Professor of Epidemiology and Public Health, Royal Free and University College Medical School

It is a mystery to me that a distinguished epidemiologist should be willing to keep such dubious company. Sadly I don’t know what he said, but judging my his publications and his appearence on Natural World, I can’t imagine he’d have much time for homeopaths.

9.25 Improving health in the workplace. Dame Carol Black, National Director, Health and Work, Department of Health

This is not the first time that Dame Carol has been comtroversial.

9.45 Integrated health in focus: defeating obesity. Professor Chris Drinkwater, President, NHS Alliance.

The NHS Alliance was mentioned above.   Enough said.

10.00 Integrated healthcare in focus: new approaches to managing asthma, eczema and allergy. Professor Stephen Holgate, Professor of Immunopharmacology, University of Southampton

10.15 Using the natural environment to increase activity. The Natural England Project: the results from year one. Dr William Bird and Ruth Tucker, Natural England.

10.30 Panel discussion

10.45 Coffee

Self help in action

11.10    Your health, your way: supporting self care through care planning and the use of personal budgets. Angela Hawley, Self Care Lead, Department of Health

11.25    NHS Life Check: providing the signposts to
integrated health. Roy Lambley, Project Director, NHS LifeCheck Programme

This programme was developed with the University of Westminster’s “Health and Well-being Network”. This group, with one exception, is separate from Westminster’s extensive alternative medicine branch (it’s mostly psychologists).

11.45    The agony and the ecstasy of helping patients to help themselves: tips for clinicians, practices and PCTs. Professor
Ruth Chambers, FIH Foundation Fellow.

11.55    Providing self help in practice: Department of Health Integrated Self Help Information Project. Simon Mills, Project Lead: Integrated Self Care in Family Practice, Culm Valley Integrated Centre for Health, Devon and Dr Sam Everington, GP, Bromley by Bow.

The Culm  Valley Integrated Centre for health is part of the College Surgery Partnership, associated with Michael Dixon OBE (yes, again!).

Simon Mills is the herbalist who says “The hot and the cold remain the trade secret of traditional medicine” .

Sam Everington, in contrast, seems to be interested in ‘integration’ in the real sense of the word, rather than quackery.

Integrated health in action


How to make sense of the evidence on complementary approaches: what works? What might work? What doesn’t work?
Dr Hugh MacPherson, Senior Research Fellow in Health Sciences, York University and Dr Catherine Zollman, Bravewell Fellow

Hugh MacPherson‘s main interest is in acupuncture and he publishes in alternative medicine journals. Since the recent analysis in the BMJ from the Nordic Cochrane Centre (Madsen et al.,  2009) it seems that  acupuncture is finally dead. Even its placebo effect is too small to be useful. Catherine Zollman is a Bristol GP who is into homeopathy as well as acupuncture.  She is closely connected with the Prince’s Foundation via the Bravewell Fellowship. That fellowship is funded by the Bravewell Collaboration, which is run by Christie Mack, wife of John Mack (‘Mack the Knife’), head of Morgan Stanley (amazingly, they still seem to have money). This is the group which, by sheer wealth, has persuaded so many otherwise respectable US universities to embrace every sort of quackery (see, for example, Integrative baloney @ Yale)

The funding of integrated services

14.15 How to get a PCT or practice- based commissioner to fund your integrated service. A PCT Chief Executive and a Practice-Based Commissioning lead.

14.30 How I succeeded: funding an integrated service. Dr John Ribchester, Whitstable

14.45 How we created an acupuncture service in St Albans and Harpenden PBC group. Mo Girach, Chief Executive, STAHCOM

Uhuh Acupunture again. Have these people never read Bausell’s
book
?  Have they not read the BMJ?  Acupuncture is now ell-established to be based on fraudulent principles, and not even to have a worthwhile placeobo effect.  STAHCOM seem to be more interested in money than in what works.

Dragon’s Den. Four pitchers lay out their stall for the commissioning dragons

And at this stage there is no prize for guessing that all four are devoted to trying to get funds for discredited treatments

  • An acupuncture service for long-term pain. Mike Cummings Chair, Medical Acupuncture Association
  • Manipulation for the treatment of back pain Simon Fielding, Founder Chairman of the General Osteopathic Council
  • Nigel Clarke, Senior Partner, Learned Lion Partners Homeopathy for long term conditions
  • Peter Fisher, Director, Royal Homeopathic Hospital

Sadly it is not stated who the dragons are. One hopes they will be more interested in evidence than the supplicants.

Mike Cummings at least doesn’t believe the nonsense about meridians and Qi. It’s a pity he doesn’t look at the real evidence though.
You can read something about him and his journal at BMJ Group promotes acupuncture: pure greed.

Osteopathy sounds a bit more respectable than the others, but in fact it has never shaken off its cult-like origins. Still many osteopaths make absurd claims to cure all sorts of diseases. Offshoots of osteopathy like ‘cranial osteopathy’ are obvious nonsense. There is no reason to think that osteopathy is any better than any other manipulative therapy and it is clear that all manipulative therapies should be grouped into one.

Osteopathy and chiropractic provide the best ever examples of the folly of giving official government recognition to a branch of alternative medicine before the evidence is in.

Learned Lion Partners is a new one on me. It seems it is
part of Madsen Gornall Ashe Chambers (‘MGA Chambers’) “a grouping of top level, independent specialists who provide a broad range of management consultancy advice to the marketing community”.  It’s a management consultant and marketing outfit.    So don’t expect too much when it comes to truth and evidence. The company web site says nothing about alternative medicine, but only that Nigel Clarke

“. . . has very wide experience of public affairs issues and campaigns, having worked with clients in many sectors in Europe, North America and the Far East. He has particular expertise in financial, competition and healthcare issues. “

However, all is revealed when we see that he is a Trustee of the Prince’s Foundation where his entry says

“Nigel Clarke is senior partner of Learned Lion Partners. He is a director of Vidapulse Ltd, Really Easy Ltd, Newscounter Ltd and Advanced Transport Systems Ltd. He has worked on the interfaces of public policy for 25 years. He has been chair of the General Osteopathic Council since May 2001, having been a lay member since it was formed. He is now a member of the Council for Healthcare Regulatory Excellence”

The Council for Healthcare Regulatory Excellence is yet another quango that ticks boxes and fails absolutely to grasp the one important point, does it work?.  I came across them at the Westminster Forum, and they seemed a pretty pathetic way to spend £2m per year.

Peter Fisher is the last supplicant to the Dragons.  He is clinical director of the Royal London Homeopathic Hospital (RLHH), and Queen’s homeopathic physician,  It was through him that I got an active interest in quackery. The TV programme QED asked me to check the statistics in a paper of his that claimed that homeopathy was good for fibrositis (there was an elementary mistake and no evidence for an effect).  Peter Fisher is also remarkable because he agreed with me that BSc degrees in homeopathy were not justified (on TV –see the movie).   And he condemned homeopaths who were caught out recommending their sugar pills for malaria.  To that extent Fisher represents the saner end of the homeopathic spectrum.  Nevertheless he still maintains that sugar pills work and have effects of their own, and tries to justify the ‘memory of water’ by making analogies with a memory stick or CD.  This is so obviously silly that no more comment is needed.

Given Fisher’s sensible condemnation of the malaria fiasco, I was rather surprised to see that he appeared on the programme of a conference at the University of Middlesex, talking about “A Strategy To Research The Potential Of Homeopathy In Pandemic Flu”.   The title of the conference was Developing Research Strategies in CAM.   A colleague, after seeing the programme, thought it was more like “a right tossers’ ball”.

Much of the homeopathy has now vanished from the RLHH as a result of greatly reduced commissioning by PCTs (read about it in Fisher’s own words). And the last homeopathy degree in the UK has closed down. It seems an odd moment for the FIH to be pushing it so hard.

Follow-up

Stop press It is reported in the Guardian (22 May 2009) that Professor Sikora has been describing his previous job at Imperial College with less than perfect accuracy. Oh dear, oh dear.

This fascinating fact seems to have been unearthed first by the admirable NHS Blog Doctor, in his post ‘Imperial College confirm that Karol Sikora does not work for them and does not speak on their behalf‘.

Jump to follow-up

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”.

The regulations state

(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

Jump to follow-up

We know all about the sixteen or so universities that run “BSc” degrees in hokum. They are all “post-1992” universities, which used to be polytechnics. That is one reason why it saddens me to see them destroying their own attempts to achieve parity with older universities by running courses that I would regard as plain dishonest.

Older universities do not run degree courses in such nonsense. Academics (insofar as they still have any influence) certainly would not put up with it if they tried. But nevertheless you can find quackery in some of the most respected universities, and it gets there not via academics but (guess what) via Human Resources.  It creeps in through two routes.  One is the “training courses” that research staff now have to do (the “Roberts agenda”).  The other route is through occupational health services.

Quackery in training courses

It isn’t easy to find out what happens elsewhere, but I was certainly surprised to find out that UCL’s own HR department was offering a course that promised to teach you the “core principles” of Brain Gym and  Neurolinguistic Programming, both totally discredited bits of psycho-babble, more appropriate to the lifestyle section of a downmarket.women’s magazine than a university.  I gather that HR’s reaction after I brought this to light was not to ask what was wrong with it, but just to get angry.

In a spirit of collegiality I offered to run a transferable skills course myself.  I even offered to do it for nothing (rather than the rumoured £700 per day charged by the life style consultants).  I proposed a course in ‘How to read critically’ (subtitle ‘How to detect bullshit’).  This seems to me to be the ultimate transferable skill. Bullshit occurs in every walk of life. My proposal was moderately worded and perfectly serious.

Guess what?  Despite several reminders, I have never had any response to my suggestion.  Well, I suppose that HR people now regard themselves as senior to mere professors and there is really no need to reply to their
letters.

Quackery in occupational health. Leicester sets a good example

If you work at a university, why not search the university’s web site for “complementary medicice” or complementary therapies”. If it is a real university, you won’t find any degrees in homeopathy, or in amethysts
that emit high yin energy
.  But some quite surprising places are found to be recommending magic medicine through their Occupational Health service, which usually seems to be part of HR.  In fact at one time even UCL was doing it, but no soon had somebody sent me the link than it disappeared. As a matter of historical record, you can see it here (it had all the usual junk, as well as harmless stuff like yoga and pilates).

While looking for something else I stumbled recently some other cases.  One was at the University of Leicester, a very good university (and alma mater to the great David Attenborough who must have done more to point out the beauty of science than just about anyone).  But we find on their staff wellbeing site, alongside some perfectly sensible stuff, a link to complementary therapies.

The list of ‘therapies’ includes not only the usual placebos, acupuncture, reiki, reflexology, but, even more exotically, a fraudulent Russian device called SCENAR therapy. They have a nice leaflet that explains all these things in words that run the whole gamut from meaningless gobbledygook to plain wrong.  Here are some examples from the leaflet.

Reflexology

“In the feet, there are reflex areas corresponding to all the parts of the body and these areas are arranged in such a way as to form a map of the body in the feet”

Reflexology has been shown to be effective for:

  • Back Pain
  • Migraine
  • Infertility
  • Arthritis

Well no, there are no such areas in your feet. That is sheer imagination.  And reflexology has not “been shown to be effective” for any of those conditions.  These claims for therapeutic efficacy are not only lies.  They are also illegal.

Reiki

Each hand position is held for a few minutes, and during this time healing energy will flow into you, balancing your energy system, releasing stress, soothing pain, and promoting your body’s natural ability to heal itself.”

This is sheer idiotic mumbo-jumbo. The “flow of healing energy” is totally imaginary. Such talk is offensive to anyone with half a brain. Insofar as they claim to heal anything, it is also illegal.  The comes SCENAR.

What is SCENAR?

SCENAR is an acronym for Self Controlled Energo- Neuro Adaptive Regulator. It is a reflex biofeedback device which when used by a qualified practitioner, can help to alleviate acute and chronic pain. It is licensed in the UK for pain relief but experience has shown that it is helpful in a wide variety of conditions.”

This is even more seriously nuts than the others.  The term “licensed” means merely that it is electrically safe. It certainly does not mean that it works.  Pubmed shows only three publications about the SCENAR device, all in Russian,

One sales site (apparently Russian) makes the following modest claim.

“A prime goal of the Russian Space Program was to provide space travelers with a portable  medical device that would become their “universal medical assistant” in space. So from the beginning, the SCENAR was designed to replace an entire medical hospital, with all its staff, diagnostic and treatment facilities, even the pharmacy. A universal, non-invasive, portable regulator of body functions (among other things) was envisaged.”

The SCENAR device (right) looks like a TV remote control (perhaps it IS a TV remote control -we aren’t anywhere told in comprehensible terms what’s in the box.  The Russian site sells also the rather baffling accessory on the right. The mind boggles.

SCENAR device

Remote rectal-vaginal electrode for SCENAR

How does this rubbish get onto the web site of a good university?

I presume that it is just another sign of what happens when universities come to be run by non-academics.  No doubt the occupational health people are well meaning and kind, but just scientifically illiterate. What about the HR person in charge of them?  They are not known for scientific literacy either (which would not matter if they stuck to their job).  But perhaps they just didn’t notice.  There is only one way to find out. Ask.  So I sent this letter.on 10th September.

Hello

I am a pharmacologist and I have a side interest in public understanding of science, alternative medicine.and medical fraud

I was quite surprised when Google led me unexpectedly to your complementary therapies page at http://www.le.ac.uk/staffwellbeing/complementary_therapy.html

There is, sad to say, a great deal of information on these pages that is simply not true. For example it has NOT been shown that reflexology has been shown to be effective in any of the conditions which you list, as far as I know
(please send me references if you think I’m wrong) “Reflexology has been shown to be effective for: Back Pain Migraine Infertility Arthritis Sleep disorders Hormonal imbalances Sports injuries Digestive disorders Stress-related condition ”

To take only one more example from this page, the SCENAR device is an even more extreme example. It is well known to be fraudulent. and has been investigated by the Washington State Attorney General.

This sort of thing is not what one would expect from a very respectable university, and it must be a great embarrassment to your excellent medical scientists.

Apart from the many scientific inaccuracies (which greatly impede the efforts of those of us who try to improve public understanding of science), you are, I hope, aware that there is a legal aspect.

Since May this year, new regulations have made it illegal to make claims for health benefits if evidence cannot be produced to show that the claims are justified.  I would like to put it to you that many of the claims made on this page are not only immoral, but also illegal.

I wondered whether you , or your HR department, would like to make any comments

Best regards

David Colquhoun


I got an immediate and very sympathetic response from the Director of HR and a week later, on17th September, he wrote

“Hi David,

I have discussed the matter with my manager of Staff Counselling and Welfare and have agreed that it is probably safest that we remove the references to ‘complimentary’[sic] therapies from the site entirely.

Thank you for your helpful input and the recommendations for reading matter.”

So there is a lesson here.  If you find this sort or stuff on your own institution’s web site, all that may be needed is a simple letter that points out what nonsense it is.  Admittedly the HR man seemed rather more worried about whether the claims were illegal than whether they were true, but either way, it worked.

Only one little snag.  As of 6 October the pages still have not been removed.

On the assumption that they eventually will be removed, I have kept copies of the Wellbeing page, of the Complementary Therapies page, and of the ‘explanatory leaflet’. They stand as part of a historical record that
shows, once again, what can happen when scientific matters get into the hands of HR. Fortunately Leicester University has an HR director who is willing to listen to advice.

Follow-up

Something seems to have gone seriously wrong. Despite the rapid response, virtually all the nonsense is still there on 13th October. It seems not to be so simple after all.

And despite several reminders, the advertisement for SCENAR ‘therapy’ is still on  the University web site on December 14th.  I know that no decision by HR can be made with fewer than 25 meetings and an awayday in Majorca, but this is getting ridiculous.


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