# DC's Improbable Science

## We know little about the effect of diet on health. That’s why so much is written about it

#### November 18th, 2013 · 20 Comments

One of my scientific heroes is Bernard Katz. The closing words of his inaugural lecture, as professor of biophysics at UCL, hang on the wall of my office as a salutory reminder to refrain from talking about ‘how the brain works’. After speaking about his discoveries about synaptic transmission, he ended thus.

 "My time is up and very glad I am, because I have been leading myself right up to a domain on which I should not dare to trespass, not even in an Inaugural Lecture. This domain contains the awkward problems of mind and matter about which so much has been talked and so little can be said, and having told you of my pedestrian disposition, I hope you will give me leave to stop at this point and not to hazard any further guesses." Drawing ©Jenny Hersson-Ringskog

The question of what to eat for good health is truly a topic about "which so much has been talked and so little can be said"

That was emphasized yet again by an editorial in the Brirish Medical Journal written by my favourite epidemiologist. John Ioannidis. He has been at the forefront of debunking hype. Its title is “Implausible results in human nutrition research” (BMJ, 2013;347:f6698.
Get pdf
).

The gist is given by the memorable statement

"Almost every single nutrient imaginable has peer reviewed publications associating it with almost any outcome."

and the subtitle

Definitive solutions won’t come from another million observational papers or small randomized trials“.

Being a bit obsessive about causality, this paper is music to my ears. It vindicates my own views, as an amateur epidemiologist, on the results of the endless surveys of diet and health.

There is nothing new about the problem. It’s been written about many times. Young & Karr (Significance, 8, 116 – 120, 2011: get pdf) said "Any claim coming from an observational study is most likely to be wrong". Out of 52 claims made in 12 observational studies, not a single one was confirmed when tested by randomised controlled trials.

Another article cited by Ioannidis, "Myths, Presumptions, and Facts about Obesity" (Casazza et al , NEJM, 2013), debunks many myths, but the list of conflicts of interests declared by the authors is truly horrendous (and at least one of their conclusions has been challenged, albeit by people with funding from Kellogg’s). The frequent conflicts of interest in nutrition research make a bad situation even worse.

The quotation in bold type continues thus.

"On 25 October 2013, PubMed listed 291 papers with the keywords “coffee OR caffeine” and 741 with “soy,” many of which referred to associations. In this literature of epidemic proportions, how many results are correct? Many findings are entirely implausible. Relative risks that suggest we can halve the burden of cancer with just a couple of servings a day of a single nutrient still circulate widely in peer reviewed journals.

However, on the basis of dozens of randomized trials, single nutrients are unlikely to have relative risks less than 0.90 for major clinical outcomes when extreme tertiles of population intake are compared—most are greater than 0.95. For overall mortality, relative risks are typically greater than 0.995, if not entirely null. The respective absolute risk differences would be trivial. Observational studies and even randomized trials of single nutrients seem hopeless, with rare exceptions. Even minimal confounding or other biases create noise that exceeds any genuine effect. Big datasets just confer spurious precision status to noise."

And, later,

"According to the latest burden of disease study, 26% of deaths and 14% of disability adjusted life years in the United States are attributed to dietary risk factors, even without counting the impact of obesity. No other risk factor comes anywhere close to diet in these calculations (not even tobacco and physical inactivity). I suspect this is yet another implausible result. It builds on risk estimates from the same data of largely implausible nutritional studies discussed above. Moreover, socioeconomic factors are not considered at all, although they may be at the root of health problems. Poor diet may partly be a correlate or one of several paths through which social factors operate on health."

Another field that is notorious for producing false positives, wirh false attribution of causality, is the detection of biomarkers. A critical discussion can be found in the paper by Broadhurst & Kell (2006), "False discoveries in metabolomics and related experiments".

"Since the early days of transcriptome analysis (Golub et al., 1999), many workers have looked to detect different gene expression in cancerous versus normal tissues. Partly because of the expense of transcriptomics (and the inherent noise in such data (Schena, 2000; Tu et al., 2002; Cui and Churchill, 2003; Liang and Kelemen, 2006)), the numbers of samples and their replicates is often small while the number of candidate genes is typically in the thousands. Given the above, there is clearly a great danger that most of these will not in practice withstand scrutiny on deeper analysis (despite the ease with which one can create beautiful heat maps and any number of ‘just-so’ stories to explain the biological relevance of anything that is found in preliminary studies!). This turns out to be the case, and we review a recent analysis (Ein-Dor et al., 2006) of a variety of such studies."

The fields of metabolomics, proteomics and transcriptomics are plagued by statistical problems (as well as being saddled with ghastly pretentious names).

### What’s to be done?

Barker Bausell, in his demolition of research on acupuncture, said:

[Page39] “But why should nonscientists care one iota about something as esoteric as causal inference? I believe that the answer to this question is because the making of causal inferences is part of our job description as Homo Sapiens.”

The problem, of course, is that humans are very good at attributing causality when it does not exist. That has led to confusion between correlation and cause on an industrial scale, not least in attempts to work out the effects of diet on health.

More than in any other field it is hard to do the RCTs that could, in principle, sort out the problem. It’s hard to allocate people at random to different diets, and even harder to make people stick to those diets for the many years that are needed.

We can probably say by now that no individual food carries a large risk, or affords very much protection. The fact that we are looking for quite small effects means that even when RCTs are possible huge samples will be needed to get clear answers. Most RCTs are too short, and too small (under-powered) and that leads to overestimation of the size of effects.

That’s a problem that plagues experimental pyschology too, and has led to a much-discussed crisis in reproducibility.

"Supplements" of one sort and another are ubiquitous in sports. Nobody knows whether they work, and the margin between winning and losing is so tiny that it’s very doubtful whether we ever will know. We can expect irresponsible claims to continue unabated.

The best thing that can be done in the short term is to stop doing large observational studies altogether. It’s now clear that inferences made from them are likely to be wrong. And, sad to say, we need to view with great skepticism anything that is funded by the food industry. And make a start on large RCTs whenever that is possible. Perhaps the hardest goal of all is to end the "publish or perish" culture which does so much to prevent the sort of long term experiments which would give the information we want.

Ioannidis’ article ends with the statement

"I am co-investigator in a randomized trial of a low carbohydrate versus low fat diet that is funded by the US National Institutes of Health and the non-profit Nutrition Science Initiative."

It seems he is putting his money where his mouth is.

Until we have the results, we shall continue to be bombarded with conflicting claims made by people who are doing their best with flawed methods, as well as by those trying to sell fad diets. Don’t believe them. The famous "5-a-day" advice that we are constantly bombarded with does no harm, but it has no sound basis.

As far as I can guess, the only sound advice about healthy eating for most people is

• don’t eat too much
• don’t eat all the same thing

You can’t make much money out of that advice.

No doubt that is why you don’t hear it very often.

## Yet another incompetent regulator. The General Pharmaceutical Council is criminally negligent

#### November 4th, 2013 · 4 Comments

The General Pharmaceutical Council (GPhC) has been the statutory body responsible for the regulation of pharmacy since 2010. It’s status is similar to that of the GMC and. heaven help us, the GCC. Before that the regulator was the same as the professional body, the Royal Pharmaceutical Society of Great Britain (RPS). The RPS proved to be as useless as most other regulators, as documented in detail in my 2008 post, At around the time it stopped being a regulator, the RPS started to condemn quackery more effectively, but by then it had lost the power to do much about it (I hope the latter wasn’t the cause of the former). The body that could do something, the GPhC has done essentially nothing. as described in this post.

I did a 2 year apprenticeship in Timothy White’s and Taylor’s Homeopathic (yes, really) Chemists in the 1950s.
My first degree was in pharmacy. I got my interest in pharmacology from reading Martindale’s Extra Pharmacopoeia in the shop. I soon decided that I didn’t really want to spend the rest of my life selling lipstick and Durex. The latter was quite a big seller because the Boots across the road didn’t sell contraceptives (they changed their minds in the 1960s).

In those days, we spent quite a lot of time making up (almost entirely ineffective) ‘tonics’ and ‘cough mixtures’. Now the job consists largely of counting pills. This has exacerbated the ‘chip on the shoulder’ attitude that was present even in the 1950s. For a long time now, pharmacists have wanted to become the a ‘third tier’ in the NHS, alongside GP practices and hospitals., after hospitals and doctors". . Here are a few comments on this proposition.

First let me say that I’ve met some very good and ethical pharmacists. I did a vacation job in a hospital pharmacy where the boss had an encyclopaedic knowledge of the effects and side effects of drugs, and of their dosage. His advice was often sought by doctors, and rightly so. He had no way of knowing at the time that his advice to replace barbiturates with thalidomide would lead to such a tragedy, because the evidence had been concealed by the manufacturer. Some of the problems alluded to here have already been highlighted by two excellent pharmacists, Anthony Cox and @SparkleWildfire, neither of whom work in pharmacists shops. They are absolutely spot on but they seem to be in a minority among pharmacists.

The problems seem to lie mostly in retail shops. Their shelves are laden with ineffective pills and potions. And the pharmacist has every incentive to sell them. His/her income depends on it directly if it’s a privately owned pharmacy. And his/her standing with head office depends on it in chain store pharmacies. This conflict of financial interest is the prime reason why pharmacists are not qualified to form a third tier of healthcare. The avoidance of conflicts of interest among doctors was one of the great accomplishments of the NHS. In the USA there are huge scandals when, as happens repeatedly, doctors order expensive and unnecessary treatments from which they profit. It’s no consolation that such problems are creeping back in the UK as a result of the government’s vigorous efforts to sell it off.

Here are few examples of things that have gone wrong, and who is to blame. Then I’ll consider what can be done.

Ineffective medicines

In any pharmacy you can see ineffective ‘tonics’ and ‘cough medicines’, unnecessary supplements with dishonest claims and even, heaven help us, the ultimate scam, homeopathic pills.

What’s worse, if you ask a pharmacist for advice, it’s quite likely that they’ll recommend you to buy them.

 I was amazed to discover that a number of old-fashioned ‘tonics’ and ‘cough medicines’ still have full marketing authorisation. That’s the fault of the Medicines and Healthcare Regulatory Auhority (MHRA) who are supposed to assess efficacy and totally failed to do so, Read about that in “Some medicines that don’t work. Why doesn’t the MHRA tell us honestly?” . It’s hard to blame a pharmacist for the bad advice given by the MHRA, but a good one would tell patients to save their money.

Big corporate pharmacies

Companies like Boots seem to have no interest whatsoever in ethical behaviour. All that matters is sales. They provide “(mis)educational” materials that promote nonsense They advertise ridiculous made-up claims in the newspapers, which get shot down regularly by the Advertising Standards Authority, but by that time the promotion is over so they don’t give a damn. See for example, CoQ10 scam and the ASA verdict on it. And "Lactium: more rubbish from Boots the Chemists. And a more serious problem". And "The Vitamin B scam. Don’t trust Boots"

Recently the consumer magazine Which? checked 122 High Street pharmacies. They got unsatisfactory advice from 43% of them, a disastrously bad performance for people who want to be the third tier of healthcare.

 Even that’s probably better than my own experience. Recently, when I asked a Sainsbury’s pharmacist about a herbal treatment for prostate problems, he pointed to the MHRA’s kite mark and said it must work because the MHRA approved it -he was quite unaware that you get the THR kite mark without having to present any evidence at all about efficacy.

Of course that is partly the fault of the MHRA for allowing misleading labels, but nevertheless, he should have known. See “Why does the MHRA refuse to label herbal products honestly? Kent Woods and Richard Woodfield tell me” for more on how the MHRA has betrayed its own standards.

When I’ve asked Boots’ pharmacists advice about persistent diarrhoea in an infant, saying I wanted a natural remedy, I’ve usually been guided to the homeopathic display. Only once was I told firmly that I should use rehydration not homeopathy (something every good parent knows) and when I asked that good pharmacist where she’d been educated, she said in Germany (mildly surprising given the amount of junk available in German pharmacies)

### Regulators

Anthony Cox, a pharmacist who has been consistently on the side of right, says

"This is something that needs to be dealt with at a regulatory and professional body by the whole profession, and I am certain we have the majority of the UK pharmacy profession on side."

But the regulator has done nothing, and it isn’t even clear that there is a majority on his side.

At a 2009 meeting of Branch Representatives of the RPS a motion was proposed:

“…registration as a pharmacist and practice as a homeopath are not compatible, and that premises registered with the Society should not be used for the promotion of homeopathy”

Although that is obviously sensible to most people, the proposal was followed by a speaker from Leicester who thought it right to keep an open mind about Avogadro’s number and the motion was defeated. So much for the "scientists on the High Street" aspiration.

There have been two major scandals surrounding homeopathy recently. Both were revealed first by bloggers, and both came to wide notice through television programs. None were noticed by the regulators, and when they were brought to the attention of the regulator, nothing effective was done.

The malaria scandal

A lot has been wriitten about this here and on other blogs e.g. here and here. The idea that sugar pills can prevent or cure malaria is so mind-bogglingly dangerous that it was condemned by the Queen’s Homeopathic Physician, Peter Fisher. It was exposed on a BBC Newsnight programme in 2006. Watch the video.

The Gentle Art of Homeopathic Killing was an article that originally appeared on the excellent Quackometer blog produced by Andy Lewis. "The Society of Homeopaths were so outraged about one of their members flouting the code of ethics so blatantly that they took immediate action. That action was, as expected, not to do anything about the ethics breach but to threaten Andy and his hosting ISP with legal action for defamation. The article is reproduced here as a public service".

Some of the people involved in this bad advice were pharmacists, Very properly they were referred to the RPS in 2006 qnd 2009, the regulator at that time. They sat on the complaint so long that eventually the RPS was replaced by the GPhC as regulator. Nothing much has happened.

The GPhC did precisely nothing. Read their pathetic response.

Homeopathy for meningitis

An equally murderous fraud, "homeopathic vaccines" by Ainsworth’s has long been targeted by bloggers. In January 2013, Samantha Smith made an excellent BBC South West programme about it. Watch it and get angry.

Anthony Pinkus, pharmacist at Ainsworths, has been referred to the then regulator, the RPS, in 2006 and 2009. It’s said that he took "remedial action", though there is little obvious change judged by the video above. No doubt some of the most incriminating stuff has been removed from his web site to hide it from the ASA. It’s safer to mislead people by word of mouth. Since the last video more complaints have been made to the GPhC. So far, nothing but silence.

### Why doesn’t the regulator regulate?

This pamphlet is reproduced from the July 2011 Quackometer post, “Ainsworths Pharmacy: Casual Disregard for the Law

 It’s almost as though those royal warrants, enlarged on right, acted as a talisman that puts this dangerous company outside the grasp of regulators. I hope that the GPhC Council , and Duncan Rudkin (its chief executive and registrar), are not so worried about their knighthoods that they won’t risk upsetting the royal family, just to save patients from malaria and meningitis. Their CEO, Robert Nicholls is only a CBE so far.

Another reason for their inaction might be that the GPhC Council members, and Duncan Rudkin (its chief executive and registrar), lack critical faculties. Perhaps they have not been very well educated? Many of them aren’t even pharmacists, but that curious breed of professional administrators who inhabit the vast number of quangos, tick their boxes and do harm. Or perhaps they are just more interested in protecting the income of pharmacists than in protecting their customers?

Education

The solution to most problems is education. But there is no real knowledge of how many pharmacists in the UK are educated in the critical assessment of evidence. A recent paper from the USA did not give cause for optimism. It’s discussed by the excellent US pharmacist, Scott Gavura, at Science-based medicine. The results are truly horrifying.

“Few students disagreed with any CAM therapy. There was the greatest support for vitamins and minerals (94%, mean 4.29) which could include the science-based use these products. But there was strong support for demonstrably ineffective treatments like acupuncture, with 64% agreeing it was acceptable. Even homeopathy, which any pharmacy student with basic medicinal chemistry skills ought to know is absurd, was supported by over 40% of students.”

If the numbers are similar in the UK, the results of the Which? magazine survey are not so surprising. And if they are held by the GPhC Council. their inaction is to be expected. We just don’t know, and perhaps someone should find out.

I suspect that sympathy for quackery may sometimes creep in through that old-fashioned discipline known as pharmacognosy. It is about the botany of medicinal plants, and it’s still taught, despite the fact that very few drugs are now extracted from plants. At times, it gets dangerously close to herbalism. For example, at the School of Pharmacy (now part of UCL) a book is used Fundamentals of Pharmacognosy and Phytotherapy  by Michael Heinrich, Joanne Barnes, Simon Gibbons and Elizabeth M. Williamson, ot the Centre for Pharmacognosy and Phytotherapy at the School of Pharmacy. The introductory chapter says.

“TRADITIONAL CHINESE MEDICINE (TCM) The study of TCM is a mixture of myth and fact, stretching back well over 5000 years. At the time, none of the knowledge was written down, apart from primitive inscriptions of prayers for the sick on pieces of tortoise carapace and animal bones, so a mixture of superstition, symbolism and fact was passed down by word of mouth for centuries. TCM still contains very many remedies, which were selected by their symbolic significance rather than proven effects; however, this does not necessarily mean that they are all ‘quack’ remedies!”

Well, not necessarily. But as in most such books, there are good descriptions of the botany, more or less good accounts of the chemical constituents followed by uncritical lists of things that the herb might (or might not) do. The fact that even the US National Institutes of Health quackery branch, NCCAM, doesn’t claim that a single herbal treatment is useful tells you all you need to know.

Joanna Barnes is Associate Professor in Herbal Medicines, School of Pharmacy, University of Auckland, New Zealand. She has written a book, Herbal Medicines (“A useful book for learning holistic medicine”) that is desperately uncritical about the alleged theraputic effectiveness of plants. ("Simon Gibbons is on the editorial board of The Chinese Journal of Natural Medicine. Elizabeth Williamson is editor of the Journal of Phytotherapy Research, a journal that has a strong flavour of herbalism (take the infamous snoring remedy). These people aren’t quacks but they are dangerously tolerant of quacks.

The warning is in the title. "Phytotherapy" is the current euphemism for herbalism. It’s one of those red light words that tells you that what follows is unlikely to be critical. Exeter’s fantasy herbalist, Simon Mills, now describes himself as a phytotherapist. What more warning could you need?

Perhaps this explains why so many pharmacists are unworried by selling things that don’t work. Pharmacy education seems not to include much about the critical assessment of evidence. It should do.

Chemist and Druggist magazine certainly doesn’t help. It continually reinforces the idea that there is a debate about homepathy. There isn’t. And in one of its CPD modules Katherine Gascoigne says

"Homeopathic remedies are available, but are best prescribed by a homeopath"

Ms Gascoigne must be living on another planet.

### Conclusions

The main conclusion from all of this is that the General Pharmaceutical Council is almost criminally negligent. It continues to allow pharmacists, Anthony Pinkus among them, to endanger lives. It fails to apply its own declared principles. The members of its Council, and Duncan Rudkin (its chief executive and registrar), are not doing their job.

Individual pharmacists vary a lot, from the superb to those who believe in quackery. Some, perhaps many, are embarrassed by the fact that their employer compels them to sell rubbish. It’s too much to expect that they’ll endanger their mortgage payments by speaking out about it, but the best ones will take you aside and explain that they can’t recommend it.

The GPhC itself is regulated by the Professional Standards Authority, the subject of my last post. We can’t expect anything sensible from them.

In the USA there is a shocking number of pharmacists who seem to believe in quackery. In the UK. nobody knows, though judging by their failure to vote against the daftest of all scams, homeopathy, there is no cause for complacency here.

It seems that there will have to be big improvements in pharmacy education before you can have much confidence in the quality of the advice that you get in a pharmacy.

### Follow-up

Yesterday a talk was given at the School of Pharmacy, organised by the “The Centre for Homeopathic Education” (an oxymoron if there ever was one). The flyer had all the usual nonsense. Its mention of “Remedies & Tonics for Cancer Recovery” might well have breached the Cancer Act (1939). When I asked whether the amount received in room rental was sufficient to offest the damage to the reputation of the School of Pharmacy resulting from hosting a nutty (and possible illegal) event, I had the greatest difficulty in extracting any sort of response from the school’s director, Duncan Craig. I’m told that he considers “the policy on space rental to be a UCL management issue, rather than a matter of discussion on scientific ethics with a colleague”. Oh dear.

## One incompetent regulator, the Professional Standards Authority, approves another, the CNHC

#### October 13th, 2013 · 10 Comments

The consistent failure of ‘regulators’ to do their job has been a constant theme on this blog. There is a synopsis of dozens of them at Regulation of alternative medicine: why it doesn’t work, and never can. And it isn’t only quackery where this happens. The ineptitude (and extravagance) of the Quality Assurance Agency (QAA) was revealed starkly when the University of Wales’ accreditation of external degrees was revealed (by me and by BBC TV Wales, not by the QAA) to be so bad that the University had to shut down.

Here is another example that you couldn’t make up.

Yes, the Professional Standards Authority (PSA) has agreed to accredit that bad-joke pseudo-regulator, the Complementary & Natural Healthcare Council (CNHC, more commonly known as Ofquack)

Ofquack was created at the instigation of HRH the Prince of Wales, at public expense, as a means of protecting the delusional beliefs of quacks from criticism. I worked for them for a while, and know from the inside that their regulation is a bad joke.

When complaints were made about untrue claims made by ‘reflexologists’, the complaints were upheld but they didn’t even reach the Conduct and Competence committee, on the grounds that the reflexologists really believed the falsehoods that they’d been taught. Therefore, by the Humpty Dumpty logic of the CNHC, their fitness to practise was not affected by their untrue claims. You can read the account of this bizarre incident by the person who submitted the complaints, Simon Perry.

In fact in the whole history of the CNHC, it has received a large number of complaints, but  only one has ever  been considered by their Conduct and Competence Committee.  The rest have been dismissed before they were considered properly.  That alone makes their claim to be a regulator seem ridiculous.

The CNHC did tell its registrants to stop making unjustified claims, but it has been utterly ineffective in enforcing that ruling. In May 2013, another 100 complaints were submitted and no doubt they will be brushed aside too: see Endemic problems with CNHC registrants..

As I said at the time

It will be fascinating to see how the CNHC tries to escape from the grave that it has dug for itself.

If the CNHC implements properly its own code of conduct, few people will sign up and the CNHC will die. If it fails to implement its own code of conduct it would be shown to be a dishonest sham.

In February of this year (2013), I visited the PSA with colleagues from the Nightingale Collaboration. We were received cordially enough, but they seemed to be bureaucrats with no real understanding of science. We tried to explain to them the fundamental dilemma of the regulation of quacks, namely that no amount of training will help when the training teaches things that aren’t true. They were made aware of all of the problems described above. But despite that, they ended up endorsing the CNHC.

### How on earth did the PSA manage to approve an obviously ineffective ‘regulator’?

The job of the PSA is said to be “. . . protecting users of health and social care services and the public”. They (or at least their predecessor, the CHRE), certainly didn’t do that during the saga of the General Chiropractic Council.

The betrayal of reason is catalogued in a PSA document [get local copy]. Here is some nerdy detail.

It is too tedious to go through the whole document, so I’ll deal with only two of its many obvious flaws, the sections that deal with the evidence base, and with training.

The criteria for accreditation state

Standard 6: the organisation demonstrates that there is a defined knowledge base underpinning the health and social care occupations covered by its register or, alternatively, how it is actively developing one. The organisation makes the defined knowledge base or its development explicit to the public.

The Professional Standards Authority recognises that not all disciplines are underpinned by evidence of proven therapeutic value. Some disciplines are subject to controlled randomized trials, others are based on qualitative evidence.  Some rely on anecdotes. Nevertheless, these disciplines are legal and the public choose to use them. The Authority requires organisations to make the knowledge base/its development clear to the public so that they may make informed decisions.

Since all 15 occupations that are “regulated” by the CNHC fall into the last category. they “rely on anecdotes”, you would imagine the fact that “The Authority requires organisations to make the knowledge base/its development clear to the public” would mean that the CNHC was required to make a clear statement that reiki, reflexology etc are based solely on anecdote. Of course the CNHC does no such thing. For example, the CNHC’s official definition of reflexology says

Reflexology is a complementary therapy based on the belief that there are reflex areas in the feet and hands which are believed to correspond to all organs and parts of the body

There is, of course, not the slightest reason to think such connections exist, but the CNHC gives no hint whatsoever of that inconvenient fact. The word “anecdote” is used by the PSA but occurs nowhere on the CNHC’s web site.

It is very clear that the CNHC fails standard 6.

But the PSA managed to summon up the following weasel words to get around this glaring failure:

“The professional associations (that verify eligibility for CNHC registration) were actively involved in defining the knowledge base for each of the 15 professions. The Panel further noted that Skills for Health has lead responsibility for writing and reviewing the National Occupational Standards (NOS) for the occupations CNHC registers and that all NOS have to meet the quality criteria set by the UK Commission for Employment and Skills (UKCES), who are responsible for the approval of all NOS across all industry sectors. The Panel considered evidence provided and noted that the applicant demonstrated that there is a defined knowledge base underpinning the occupations covered by its registers. The knowledge base was explicit to the public”.

The PSA, rather than engaging their own brains, simply defer to two other joke organisations, Skills for Health and National Occupational Standards. But it is quite obvious that for things like reiki, reflexology and craniosacral therapy, the “knowledge base” consists entirely of made-up nonsense. Any fool can see that (but not, it seems, the PSA).

Skills for Health lists made-up, HR style, “competencies” for everything under the sun. When I got them to admit that their efforts on distance-healing etc had been drafted by the Prince of Wales’ Foundation, the conversation with Skills for Health became surreal (recorded in January 2008)

DC. Well yes the Prince of Wales would like that. His views on medicine are well known, and they are nothing if not bizarre. Haha are you going to have competencies in talking to trees perhaps?

“You’d have to talk to LANTRA, the land-based organisation for that.”

DC. I’m sorry, I have to talk to whom?

“LANTRA which is the sector council for the land-based industries uh, sector, not with us sorry . . . areas such as horticulture etc.”

DC. We are talking about medicine aren’t we? Not horticulture.

“You just gave me an example of talking to trees, that’s outside our remit ”

You couldn’t make it up, but it’s true. And the Professional Standards Authority rely on what these jokers say.

The current Skills for Health entry for reflexology says

“Reflexology is the study and practice of treating reflex points and areas in the feet and hands that relate to corresponding parts of the body. Using precise hand and finger techniques a reflexologist can improve circulation, induce relaxation and enable homeostasis. These three outcomes can activate the body’s own healing systems to heal and prevent ill health.”

This is crass, made-up nonsense. Of course there are no connections between “areas in the feet and hands that relate to corresponding parts of the body” and no reason to think that reflexology is anything more than foot massage. That a very expensive body, paid for by you and me, can propagate such preposterous nonsense is worrying. That the PSA should rely on them is even more worrying.

National Occupational Standards is yet another organisation that is utterly dimwitted about medical matters, but if you look up reflexology you are simply referred to Skills for Health, as above.

UK Commission for Employment and Skills
(UKCES)
is a new one on me. The PSA says that “the UK Commission for Employment and Skills (UKCES), who are responsible for the approval of all NOS across all industry sectors” It is only too obvious that the UKCES leadership team have failed utterly to do their job when it comes to made-up medicine. None of them know much about medicine. It’s true that their chairman did once work for SmithKline Beecham, but as a marketer of Lucozade, a job which anyone with much knowledge of science would not find comfortable..

You don’t need to know much medicine to spot junk. I see no excuse for their failure.

The training problem.

The PSA’s criteria for accreditation say

Standard 9: education and training

The organisation:

9a) Sets appropriate educational standards that enable its registrants to practise competently the occupation(s) covered by its register. In setting its standards the organisation takes account of the following factors:

• The nature and extent of risk to service users and the public
• The nature and extent of knowledge, skill and experience required to provide
service users and the public with good quality care

and later

9b) Ensures that registrants who assess the health needs of service users and provide any form of care and treatment are equipped to:

• Recognise and interpret clinical signs of impairment
• Recognise where a presenting problem may mask underlying pathologies
• Have sufficient knowledge of human disease and social determinants of health to identify where service users may require referral to another health or social care professional.

Anyone who imagines for a moment that a reflexologist or a craniosacral therapist is competent to diagnose a subarachnoid haemorrhage or malaria must need their head examining. In any case, the CNHC has already admitted that their registrants are taught things that aren’t true, so more training presumably means more inculcation of myths.

So how does the PSA wriggle out of this? Their response started

“The Panel noted that practitioners must meet, as a minimum, the National Occupational Standards for safe and competent practice. This is verified by the professional associations, who have in turn provided written undertakings to CNHC affirming that there are processes in place to verify the training and skills outcomes of their members to the NOS”

Just two problems there. The NOS standards themselves are utterly delusional. And checking them is left to the quacks themselves. To be fair, the PSA weren’t quite happy with this, but after an exchange of letters, minor changes enabled the boxes to be ticked and the PSA said “The Panel was now satisfied from the evidence provided, that this Standard had been
met”.

### What’s wrong with regulators?

This saga is typical of many other cases of regulators doing more harm than good. Regulators are sometimes quacks themselves, in which case one isn’t surprised at their failure to regulate.

But organisations like the Professional Standards Authority and Skills for Health are not (mostly) quacks themselves. So how do they end up giving credence to nonsense? I find that very hard to comprehend, but here are a few ideas.

(1) They have little scientific education and are not really capable of critical thought

(2) Perhaps even more important, they lack all curiosity. It isn’t very hard to dig under the carapace of quack organisations, but rather than finding out for themselves, the bureaucrats of the PSA are satisfied by reassuring letters that allow them to tick their boxes and get home.

(3) A third intriguing possibility is that people like the PSA yield to political pressure. The Department of Health is deeply unscientific and clearly has no idea what to do about alternative medicine. They have still done nothing at all about herbal medicine, traditional Chinese medicine or homeopathy, after many years of wavering. My guess is that they see the CNHC as an organisation that gives the appearance that they’ve done something about reiki etc. I wonder whether they applied pressure to the PSA to accredit CNHC, despite it clearly breaking their own rules. I have sent a request under the Freedom of Information Act in an attempt to discover if the Department of Health has misbehaved in the way it did when it attempted to override NHS Choices.

The responsibility for this cock-up has to rest squarely on the shoulders of the PSA’s director, Harry Cayton. He was director of the CHRE from which PSA evolved and is the person who so signally failed to do anything about the General Chiropractic Council fiasco,

### What can be done?

This is just the latest of many examples of regulators who not only fail to help but actually do harm by giving their stamp of approval to mickey mouse organisations like the CNHC. Most of the worst quangos survived the “bonfire of the quangos”.. The bonfire should have started with the PSA, CNHC and Skills for Health. They cost a lot and do harm.

There is a much simpler answer. There is a good legal case that much of alternative medicine is illegal. All one has to do is to enforce the existing law. Nobody would object to quacks if they stopped making false claims (though whether they could stay in business if they stopped exaggerating is debatable). There is only one organisation that has done a good job when it comes to truthfulness. That is the Advertising Standards Authority. But the ASA can do nothing apart from telling people to change the wording of their advertisements, and even that is often ignored.

The responsibility for enforcing the Consumer Protection Law is Trading Standards. They have consistently failed to do their job (see Medico-Legal Journal, Rose et al., 2012. “Spurious Claims for Health-care Products“.

If they did their job of prosecuting people who defraud the public with false claims, the problem would be solved.

But they don’t, and it isn’t.

### Follow-up

The indefatigable Quackometer has wriiten an excellent account of the PSA fiasco

## A review of Do You Believe in Magic, by Paul Offit. And a fine piece of timidity from Nature Medicine

#### August 27th, 2013 · 5 Comments

Despite the First Amendment in the US and a new Defamation Act in the UK, fear of legal threats continue to suppress the expression of honest scientific opinion.

I was asked by Nature Medicine (which is published in the USA) to write a review of Paul Offit’s new book. He’s something of a hero, so of course I agreed. The editor asked me to make some changes to the first draft, which I did. Then the editor concerned sent me this letter.

 Thank you for the revised version of the book review. The chief editor of the journal took a look at your piece, and he thought that it would be a good idea to run it past our legal counsel owing to the strong opinions expressed in the piece in relation to specific individuals. I regret to say that the lawyers have advised us against publishing the review.

After that I tried the UK Conversation. They had done a pretty good job with my post on the baleful influence of royals on medicine. They were more helpful then Nature Medicine, but for some reason that I can’t begin to understand, they insisted that I should not name Nature Medicine, but to refer only to "a leading journal". And they wanted me not to name Harvard in the last paragraph. I’m still baffled about why. But it seemed to me that editorial interference had gone too far, so rather than have an editor re-write my review, I withdrew it.

It is precisely this sort of timidity that allows purveyors of quackery such success with their bait and switch tactics. The fact that people seem so terrified to be frank must be part of the reason why Harvard, Yale and the rest have shrugged their shoulders and allowed nonsense medicine to penetrate so deeply into their medical schools. It’s also why blogs now are often better sources of information than established journals.

Here is the review. I see nothing defamatory in it.

### Do You Believe in Magic? The Sense and Nonsense of Alternative Medicine

 Paul A. Offit Harper, 2013 336 pp., hardcover $26.99 ISBN: 0062222961 Reviewed by David Colquhoun Research Professor of Pharmacology, UCL. Here’s an odd thing. There is a group of people who advocate the silly idea that you can cure all ills by stuffing yourself with expensive pills, made by large and unscrupulous Pharma companies. No, I’m not talking about pharmacologists or doctors or dietitians. They mostly say that stuffing yourself with pills is often useless and sometimes harmful, because that’s what the evidence says . Rather, the pill pushers are the true believers in the alternative realities of the “supplement” industry. They seem blithely unaware that the manufacturers are mostly the same big pharma companies that they blame for trying to suppress “natural remedies”. Far from trying to suppress them, pharma companies love the supplement industry because little research is needed and there are few restrictions on the claims that can be made. Paul Offit’s excellent book concentrates on alternative medicine in the USA, with little mention of the rest of the world. He describes how American pork barrel politics have given supplement hucksters an almost unrestricted right to make stuff up. Following the thalidomide tragedy, which led to birth defects in babies in the 1950s and 60s, many countries passed laws that required evidence that a drug was both effective and safe before it could be sold. This was mandate by the Kefauver-Harris amendment (1961) in the USA and the Medicines Act (1968) in the UK. Laws like that upset the quacks, and in the UK the quacks got a free pass, a ‘licence of right‘, largely still in existence.  In order to sell a herbal concoction in the UK you need to present no evidence at all that it works, just evidence of safety, in return for which you get a reassuring certification mark and freedom to use misleading brand names and labels. Tradional herbal mark In the USA the restrictions didn’t last long. Offit describes how a lobby group for vitamin sellers, the National Health Federation, had a board made up of quacks, some of whom, according to Offit (page 73) had convictions. They found an ally in Senator William Proxmire who introduced in 1975 an amendment that banned the Food and Drugs Administration (FDA) from regulating the safety of megavitamins. Tragically, this bill was even supported by the previously-respected scientist Linus Pauling. Offit tells us that “to Proxmire” became a verb meaning to obstruct science for political gain. The author then relates how the situation got worse with the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994. It was passed with the help of ex-vitamin salesman Senator Orin Hatch and lots of money from the supplement industry. This act iniquitously defined a “supplement” as “a product intended to supplement the diet that bears or contains one or more of the following ingredients: a vitamin, a mineral, an herb or other botanical, or an amino acid”. At a stroke, herbs were redefined as foods. There was no need to submit any evidence of either efficacy or even of safety, before marketing anything. All a manufacturer had to do to sell almost any herbal drug or megadose vitamin was to describe it as a “dietary supplement”. The lobbying to get this law through was based on appealing to the Tea Party tendency –get the government’s hands off our vitamins. And it was helped by ‘celebrities’ such as Sissy Spacek and Mel Gibson (it’s impossible to tell whether they really believed in the magic of vitamins, or whether they were paid, or had Tea Party sympathies). Offit’s discussion of vaccination is a heartbreaking story of venom and misinformation. As co-inventor of the first rotavirus vaccine he’s responsible for saving many lives around the world. But he, perhaps more than anyone, suffered from the autism myth started by the falsified work of Andrew Wakefield. The scientific community took the question seriously and soon many studies showed absolutely no link between vaccination and autism. But evidence did not seem to interest the alternative world. Rather than Offit being lauded as a saver of children’s lives, he describes how he was subjected to death threats and resorted to having armed guards at meetings. Again, Offit tells us how celebrities were able to sway public opinion For example (chapter 6), the actress Jenny McCarthy and talk-show hostess Oprah Winfrey promoted, only too successfully, the vaccine-autism link despite abundant evidence that it didn’t exist, and promoted a number of theories that were not supported by any evidence, such as the idea that autism can be “cured” by mega-doses of vitamins and supplements. Of course vaccines like the one for rotavirus can’t be developed without pharmaceutical companies because, as Offit says, only they "have the resources and expertise to make a vaccine. We can’t make it in our garage". When the Children’s Hospital of Philadelphia sold its royalty stake in the rotavirus vaccine for$182 million, Offit received an undisclosed share of the intellectual property, “in the millions ”.

That’s exactly what universities love. We are encouraged constantly to collaborate with industry, and, in the process, make money for the university. It’s also what Wakefield, and the Royal Free Hospital where he worked, hoped to do.  But sadly, these events led to Offit being called names such as “Dr Proffit” and “Biostitute” (to rhyme with “prostitute”) by people like Jenny McCarthy and Robert F. Kennedy Jr.  The conspiritorialist public lapped up this abuse, but appeared not to notice that many quacks have become far richer by peddling cures that do not work.

One lesson from this sad story is that we need to think more about the potential for money to lead to good science being disbelieved, and sometimes to corrupt science.

Everyone should buy this book, and weep for the gullibility and corruption that it describes.

I recommend it especially to the deans of US Medical schools, from Harvard downwards, who have embraced “integrative medicine” departments. In doing so they have betrayed both science and their patients.

Abraham Flexner, whose 1910 report first put US medicine on a sound scientific footing, must be turning in his grave.

### Follow-up

30 August 2013

Quack lobby groups got a clause inserted into Obamacare that will make any attempt to evaluate whether a treatment actually works will leave insurance companies open to legal action for "discrimination".

"Discrimination? Yes! We must not allow the government to exclude health care providers just because those providers don’t cure anything."

The latest piece of well-organised corporate corruption by well-funded lobbyists is revealed by Steven Salzberg, in Forbes Magazine. The chaos in the US health system makes one even more grateful for the NHS and for the evaluation of effectiveness of treatments by NICE.

## The Quacktitioner Royal is a threat to constitutional government and to the health of the nation

#### July 30th, 2013 · 6 Comments

This article has appeared, in nearly identical form, on the UK Conversation . You can leave comments there or here.

A constitutional monarch is purely ceremonial and plays no part in politics.  Well actually in the UK it isn’t quite as simple as that. The first problem is that we have no constitution.  Things haven’t changed much since the 19th century when Walter Bagehot said "the Sovereign has, under a constitutional monarchy… three rights—the right to be consulted, the right to encourage, the right to warn."

These are not inconsiderable powers in a country which is meant to be run by elected representatives.  But nobody knows how these powers are used: it is all done in secret.  Well, almost all. Charles, Prince of Wales, has been unusually public in expressing his views.  He told a conference at St James’s Palace “I was accused once of being the enemy of the Enlightenment” “I felt proud of that.”  That’s a remarkable point of view for someone who, if he succeeds, will become the patron of that product of the age of enlightenment, the Royal Society.

I have no doubt that Prince Charles means well.  He can’t be blamed for his lack of education.  But his views on medicine date from a few centuries ago, and he has lost no opportunity to exploit his privileged position to proclaim them.

Euphemisms for quackery

He set up the Prince’s Foundation for Integrated Health (PFIH) to promote his views. ( “Integrated”, in this context, is, of course, just the latest euphemism for “alternative” or “quack”.)   When the Foundation collapsed because of a financial scandal in 2010, it was replaced by the “College of Medicine”.  The name changed, but not the people behind it.  Initially this phoenix was to be named the “College of Integrated Health”, but by this time the prince’s views on medicine had become sufficiently discredited that the word “integrated” was quickly dropped.  This might be thought less than frank, but it is just employment of the classic bait and switch technique, beloved by used car salesmen.

His views were well publicised in a PFIH publication, “Complementary Healthcare: a Guide for Patients”. That volume either omitted or misrepresented the evidence about the one question that matters most to patients – does the treatment work or not?  It caused me to write a much shorter, but more accurate, version, the Patients’ Guide to Magic Medicine.  The PFIH guide was arguably a danger to public health. When, very properly, it was criticised by Edzard Ernst, a letter was sent from from the prince’s private secretary to Ernst’s vice-chancellor, Steve Smith.  Instead of defending Ernst’s public spirited action, Smith instituted disciplinary proceedings against Ernst that lasted for a year.  The prince had intervened directly in the affairs of the university.  Steve Smith was rewarded with a knighthood in 2011.

None of this criticism has dimmed the prince’s enthusiasm for barmy medical ideas.  He is well known to write many letters to government ministers to try to persuade them to adopt his ideas in a whole range of areas.  In July 2013, the Minister of Health, Jeremy Hunt, visited the prince at Clarence House.  The visit was reported to be to persuade the minister to defend homeopathy, though it was more likely to have been to press the case to confer a government stamp of approval on herbalists and traditional Chinese Medicine practitioners by giving them statutory regulation.  This is a matter that was recently raised again in parliament by Charles’ greatest ally, David Tredinnick MP (Con, Bosworth) who got into trouble for charging astrology software to expenses.  We shall never know what pressure was applied.  A ruling of the Information Commissioner judged, reasonably enough, that there was public interest in knowing what influences were being brought to bear on public policy.  But the Attorney General overruled the judgement on the grounds that “Disclosure of the correspondence could damage The Prince of Wales’ ability to perform his duties when he becomes King.”  That, of course, is exactly what we are worried about.

Influence on politics

The prince’s influence seems to be big in the Department of Health (DH).  He was given £37,000 of taxpayers’ money to produce his guide, and an astonishing £900,000 to prepare the ground for the setting up of the hapless self-regulator, the Complementary and Natural Healthcare Council (CNHC, also known as Ofquack).  When NHS Choices (itself set up by DH to assess evidence) tried to rewrite its web page about that most discredited of all forms of quackery, homeopathy, officials in DH referred the new advice to Michael Dixon, the medical director of the Prince’s Foundation and, were it not for the Freedom of Information act, the DH would have caused inaccurate information to be provided. The DH has a chief medical officer and two scientific advisors, but prefers to take the advice of the Prince of Wales.

The Prince of Wales’ business, Duchy Originals, has been condemned by the Daily Mail, (of all places) for selling unhealthy foods. And when his business branched into selling quack “detox” and herbal nonsense he found himself censured by both the MHRA and the Advertising Standards Authority (ASA) for making unjustifiable medical claims for these products.

Ainsworth’s homeopathic pharmacy is endorsed by both Prince Charles and the Queen: it has two Royal Warrants.  They sell “homeopathic vaccines” for meningitis, measles, rubella and whooping cough. These “vaccines” contain nothing whatsoever so they are obviously a real danger to public health.  Despite the fact that Ainsworth’s had already been censured by the ASA in 2011 for selling similar products, Ainsworth’s continued to recommend them with a “casual disregard for the law”. The regulator (the MHRA) failed to step in to stop them until it was eventually stirred into action by a young BBC reporter, Sam Smith, made a programme for BBC South West.  Then, at last, the somnolent regulator was stirred into action.  The MHRA “told Ainsworths to stop advertising a number of products” (but apparently not to stop making them or selling them).  They still sell Polonium metal 30C and Swine Meningitis 36C, and a booklet that recommends homeopathic “vaccination”. Ainsworth’s sales are no doubt helped by the Royal Warrants.  The consequence is that people may die of meningitis. In 2011, the MHRA Chief Executive Professor Kent Woods, was knighted.

It runs in the family

The Prince of Wales is not the only member of the royal family to be obsessed with bizarre forms of medicine. The first homeopath to the British royal family, Frederick Quin, was a son of the Duchess of Devonshire (1765-1824).  Queen Mary (1865-1953), wife of King George V, headed the fundraising efforts to move and expand the London Homeopathic Hospital.

King George VI was so enthusiastic that in 1948 conferred the royal title on the London Homeopathic Hospital.  The Queen Mother loved homeopathy too (there is no way to tell whether this contributed to her need for a colostomy in the 1960s).

The present Queen’s homeopathic physician is Peter Fisher, who is medical director of what, until recently was called the Royal London Homeopathic Hospital (RLHH).  In 2010 that hospital was rebranded as the Royal London Hospital for Integrated Medicine (RLHIM) in another unsubtle bait and switch move.

 The RLHIM is a great embarrassment to the otherwise excellent UCLH Trust.  It has been repeatedly condemned by the Advertising Standards Authority for making false claims.  As a consequence, it has been forced to withdraw all of its patient information. The patron of the RLHIM is the Queen, not the Prince of Wales.  It is hard to imagine that this anachronistic institution would still exist if it were not for the influence, spoken or unspoken, of the Queen.  Needless to say we will never be told. The Queen and Peter Fisher Observer 8 April 2007

The attorney general, while trying to justify the secrecy of Charles’ letters, said

“It is a matter of the highest importance within our constitutional framework that the Monarch is a politically neutral figure”.

Questions about health policy are undoubtedly political, and the highly partisan interventions of the prince in the political process make his behaviour unconstitutional. They endanger the monarchy itself.  Whether that matters depends on how much you value tradition and how much you value the tourist business generated by the Gilbert & Sullivan flummery at which royals excel.

The least that one can ask of the royal family is that they should not endanger the health of the nation.  If I wanted to know the winner of the 2.30 at Ascot, I’d ask a royal. For any question concerning science or medicine I’d ask someone with more education.

Here is some more interesting reading

Michael Baum’s “An open letter to the Prince of Wales: with respect, your highness, you’ve got it wrong”

Gerald Weissman’s essay Homeopathy: Holmes, Hogwarts, and the Prince of Wales.

Channel 4 TV documentary HRH “meddling in politics”

Observer April 2007 "Royals’ favoured hospital at risk as homeopathy backlash gathers pace. The Queen loves it. But alternative medicine centre’s future looks uncertain as more NHS trusts axe funding"

## Connect Physical Health sells quackery to NHS

#### June 10th, 2013 · 15 Comments

A constant theme of this blog is that the NHS should not pay for useless treatments. By and large, NICE does a good job of preventing that. But NICE has not been allowed by the Department of Health to look at quackery.

I have the impression that privatisation of many NHS services will lead to an increase in the provision of myth-based therapies. That is part of the "bait and switch" tactic that quacks use in the hope of gaining respectability. A prime example is the "College of Medicine", financed by Capita and replete with quacks, as one would expect since it is the reincarnation of the Prince’s Foundation for Integrated Health.

One such treatment is acupuncture. Having very recently reviewed the evidence, we concluded that "Acupuncture is a theatrical placebo: the end of a myth". Any effects it may have are too small to be useful to patients. That’s the background for an interesting case study.

A colleague got a very painful frozen shoulder. His GP referred him to the Camden & Islington NHS Trust physiotherapy service. That service is now provided by a private company, Connect Physical Health.

That proved to be a big mistake. The first two appointments were not too bad, though they resulted in little improvement. But at the third appointment he was offered acupuncture. He hesitated, but agreed, in desperation to try it. It did no good. At the next appointment the condition was worse. After some very painful manipulation, the physiotherapist offered acupuncture again. This time he refused on the grounds that "I hadn’t noticed any effect the first time, because there is no evidence that it works and that I was concerned by her standards of hygiene". The physiotherapist then became "quite rude" and said that she would put down that the patient had refused treatment.

The lack of response was hardly surprising. NHS Evidence says

"There is no clinical evidence to show that other treatments, such as transcutaneous electrical nerve stimulation (TENS), Shiatsu massage or acupuncture are effective in treating frozen shoulder."

In fact it now seems beyond reasonable doubt that acupuncture is no more than a theatrical placebo.

According to Connect’s own web site “Our services are evidence-based”. That is evidently untrue in this case, so I asked them for the evidence that acupuncture was effective.

I’d noticed that in other places, Connect Physical Health also offers the obviously fraudulent craniosacral therapy (for example, here) and discredited chiropractic quackery. So I asked them about the evidence for their effectiveness too.

This is what they said.

 Many thanks for your comments via our web site. In response, we thought you might like to access the sources for some of the evidence which underpins our MSK services: Integrating Evidence-Based Acupuncture into Physiotherapy for the Benefit of the Patient – you can obtain the information you require from www.aacp.org.uk The General Chiropractic Council www.gcc-uk.org/page.cfm We have also attached a copy of the NICE Guidelines.

So, no Cochrane reviews, no NHS Evidence. Instead I was referred to the very quack organisations that promote the treatments in question, the Acupuncture Association of Chartered Physiotherapists, and the totally discredited General Chiropractic Council.

The NICE guidelines that they sent were nothing to do with frozen shoulder. They were the guidelines for low back pain which caused such a furore when they were first issued (and which, in any case, don’t recommend chiropractic explicitly).

When I pointed out these deficiencies I got this.

So, "don’t blame us, blame the PCT". A second letter asked why they were shirking the little matter of evidence.

 In response to your last email, I would like to say that Connect does not wish to be drawn into a debate over two therapeutic options (acupuncture and craniosacral therapy) that are widely practiced [sic] within and outside the NHS by very respectable practitioners. You will be as aware, as Connect is, that there are lots of treatments that don’t have a huge evidence base that are practiced in mainstream medicine. Connect has seen many carefully selected patients helped by acupuncture and manual therapy (craniosacral therapy / chiropractic) over many years. Lack of evidence doesn’t mean they don’t work, just that benefit is not proven. Furthermore, nowhere on our website do we state that ALL treatments / services / modalities that Connect offer are ‘Evidence Based’. We do however offer many services that are evidence based, where the evidence exists. We aim to offer ‘choice’ to patients, from a range of services that are safe and delivered by suitably trained professionals and practitioners in line with Codes of Practice and Guidelines from the relevant governing bodies. Connect’s service provision in Camden is meticulously assessed and of a high standard and we are proud of the services provided.

This response is so wrong, on so many levels, that I gave up on Mr Philpott at this point. At least he admitted implicitly that all of their treatments are not evidence-based. In that case their web site needs to change that claim.

If, by "governing bodies" he means jokes like the GCC or the CNHC then I suppose the behaviour of their employees is not surprising. Mr Philpott is evidently not aware that "craniosacral therapy" has been censured by the Advertising Standards Authority. Well he is now, but evidently doesn’t seem to give a damn.

Next I wrote to the PCT and it took several mails to find out who was responsible for the service. Three mails produced no response so I sent a Freedom of Information Act request. In the end I got some

"Connect PHC provide the Community musculoskeletal service for Camden. The specification for the service specifically asks for the provision of evidence based management and treatments see paragraph on Governance page 14 of attached.. Patients are treated with acupuncture as per the NICE Guidelines (May 2009) for  the management of low back pain … . .. Chiropractors are not employed in the service and craniosacral therapy is not provided as part of the service either."

Another letter, pointing out that they were using acupuncture for things other than low back pain got no more information. They did send a copy of the contract with Connect. It makes no mention whatsoever of alternative treatments. It should have done, so part of the responsibility for the failure must lie with the PCT.

The contract does, however, say (page 18)

The service to be led by a lead clinician/manager who can effectively demonstrate ongoing and evidence-based development of clinical guidelines, policies and protocols for effective working practices within the service

In my opinion, Connect Physical Health are in breach of contract

Another example of Connect ignoring evidence

The Connect Physical Health web site has an article about osteoarthritis of the knee

Physiotherapy can be extremely beneficial to help to reduce the symptoms of OA. Treatments such as mobilizations, rehab exercises, acupuncture and taping can help to reduce pain, increase range of movement, increase muscle strength and aid return to functional activities and sports.

There is little enough evidence that physiotherapy does any of these things, but at least it is free of mystical mumbo-jumbo. Although at one time the claim for acupuncture was thought to have some truth, the 2010 Cochrane review concludes otherwise

Sham-controlled trials show statistically significant benefits; however, these benefits are small, do not meet our pre-defined thresholds for clinical relevance, and are probably due at least partially to placebo effects from incomplete blinding.

This conclusion is much the same as has been reached for acupuncture treatments of almost everything. Two major meta-analyses come to similar conclusions. Madsen Gøtzsche & Hróbjartsson (2009) and Vickers et al (2012) both conclude that if there is an effect at all (dubious) then it is too small to be noticeable to the patient. (Be warned that in the case of Vickers et al. you need to read the paper itself because of the spin placed on the results in the abstract.). These papers are discussed in detail in our recent paper.

Why is Connect Physical Health not aware of this?

Their head of operations told me (see above) that

"Connect does not wish to be drawn into a debate [about acupuncture and craniosacral therapy]".

That outlook was confirmed when I left a comment on their osteoarthritis post. This is what it looked like almost a month later.

Guess what? The comment has never appeared..

The attitude of Connect Physical Health to evidence is simply to ignore it if it gets in the way of making money, and to censor any criticism.

### What have Camden NHS done about it?

The patient and I both complained to Camden NHS in August 2012. At first, they simply forwarded the complaints to Connect Physical Health with the unsatisfactory results shown above. It took until May 2013 to get any sort of reasonable response. That seems a very long time. In fact by the time the response arrived the PCT had been renamed a Clinical Commissioning Group (CCG) because of the vast top-down reorganisation inposed by Lansley’s Health and Social Care Act.

On 8 May 2013, this response was sent to the patient, Here is part of it.

This response raises more questions than it answers.

For example, what is "informed consent" worth if the therapist is his/herself misinformed about the treatment? It is the eternal dilemma of alternative medicine that it is no use referring to well-trained practitioners, when their training has inculcated myths and untruths.

There is not a "growing body of evidence supporting the use of acupuncture". Precisely the opposite is true.

And the statement "until such time as there is specific evidence against it I don’t think we would be absolutely against the practice of this modality alongside" betrays a basic misunderstanding of the scientific process.

So I sent the writer of this letter a reprint of our paper, "Acupuncture is a theatrical placebo: the end of a myth" (the blog version alone has had over 12,000 page views). A few days later we had an amiable lunch together and we had a constructive discussion about the problems of deciding what should be commissioned and what shouldn’t.

It seems to me to be clear that CCGs should take better advice before boasting that they commission evidence-based treatments.

Postscript

Stories like this are worrying to the majority of physiotherapists who don’t go in for mystical mumbo-jumbo of acupuncture. One of the best is Neil O’Connell who blogs at BodyInMind. He tweeted

It isn’t clear how many physiotherapists embrace nonsense, but the Acupuncture Association of Chartered Physiotherapists has around 6000 members, compared with 47,000 chartered physiotherapists (AACP), so it’s a smallish minority. The AACP claims that it is “Integrating Evidence-Based Acupuncture into Physiotherapy”. Like most politicians, the term “evidence-based” is thrown around with gay abandon. Clearly they don’t understand evidence.

### Follow-up

12 June 2013

The Advertising Standards Authority has, one again, upheld complaints against the UCLH Trust, for making false claims in its advertising. This time, appropriately, it’s about acupuncture. Just about everything in their advertising leaflets was held to be unjustifiable. They’ve been in trouble before about false claims for homeopathy, hypnosis and craniosacral "therapy".

Of course all of these embarrassments come from one very small corner of the UCLH Trust, the Royal London Hospital for Integrated Medicine (previously known as the Royal London Homeopathic Hospital).

Why is it tolerated in an otherwise excellent NHS Trust? Well, the patron is the Queen herself (not Charles, aka the Quacktitioner Royal), She seems to exert more power behind the scenes than is desirable in In a constitutional monarchy

29 June 2013

I wrote to Dr Gill Gaskin about the latest ASA judgement against RLHIM. She is the person at the UCLH Trust who has responsibility for the quack hospital. She previously refused to do anything about the craniosacral nonsense that is promoted there. This time the ASA seems to have stung them into action at long last. I was told

 In response to your question about proposed action: All written information for patients relating to the services offered by the Royal London Hospital for Integrated Medicine are being withdrawn for review in the light of the ASA’s rulings (and the patient leaflets have already been withdrawn). It will be reviewed and modified where necessary item by item, and only reintroduced after sign-off through the Queen Square divisional clinical governance processes and the Trust’s patient information leaflet team. With best wishes Gill Gaskin Dr Gill Gaskin Medical Director Specialist Hospitals Board UCLH NHS Foundation Trust

It remains to be seen whether the re-written information is accurate or not.

Homeopathy The CAP advice and 2013 update

## Blogs lead in critical thinking, but newspapers still matter

#### June 10th, 2013 · 4 Comments

Here is a record of a couple of recent newspaper pieces. Who says the mainstream media don’t matter any longer? Blogs may be in the lead now when it comes to critical analysis. The best blogs have more expertise and more time to read the sources than journalists. But the mainstream media get the message to a different, and much larger, audience.

The Observer ran a whole page interview with me as part of their “Rational Heroes” series. I rather liked their subtitle [pdf of article]

“Professor of pharmacology David Colquhoun is the take-no-prisoners debunker of pseudoscience on his unmissable blog”

It was pretty accurate apart from the fact that the picture was labelled as “DC in his office”. Actually it was taken (at the insistence of the photographer) in Lucia Sivilotti’s lab.

Photo by Karen Robinson.

The astonishing result of this was that on Sunday the blog got a record 24,305 hits. Normally it gets 1,000-1,400 hits a day . between posts, fewer on Sunday, and the previous record was around 7000/day

A week later it was still twice normal. It remains to be seen whether the eventual plateau stays up.

I also gained around 1000 extra followers on twitter, though some dropped away quite soon, and 100 or so people signed for email updates. The dead tree media aren’t yet dead. I’m happy to say.

3 June 2013

Perhaps as a result of the foregoing piece, I got asked to write a column for The Observer, at barely 48 hours notice. This is the best I could manage in the time. The web version has links.

This attracted the usual "it worked for me" anecdotes in the comments, but I spent an afternoon answering them. It seems important to have a dialogue, not just to lecture the public. In fact when I read a regular scientific paper, I now find myself looking for the comment section. That may say something about the future of scientific publishing.

It is for others to judge how succesfully I engage with the public, but I was quite surprised to discover that UCL’s public engagement unit, @UCL_in_public, has blocked me on twitter. Hey ho. They have 1574 follower and I have 7597. I wish them the best of luck.

## Acupuncture is a theatrical placebo: the end of a myth

#### May 30th, 2013 · 22 Comments

Anesthesia & Analgesia is the official journal of the International Anesthesia Research Society. In 2012 its editor, Steven Shafer, proposed a head-to-head contest between those who believe that acupuncture works and those who don’t. I was asked to write the latter. It has now appeared in June 2013 edition of the journal [download pdf]. The pro-acupuncture article written by Wang, Harris, Lin and Gan appeared in the same issue [download pdf].

Acupuncture is an interesting case, because it seems to have achieved greater credibility than other forms of alternative medicine, despite its basis being just as bizarre as all the others. As a consequence, a lot more research has been done on acupuncture than on any other form of alternative medicine, and some of it has been of quite high quality. The outcome of all this research is that acupuncture has no effects that are big enough to be of noticeable benefit to patients, and it is, in all probablity, just a theatrical placebo.

After more than 3000 trials, there is no need for yet more. Acupuncture is dead.

### Acupuncture is a theatrical placebo

David Colquhoun (UCL) and Steven Novella (Yale)

Anesthesia & Analgesia, June 2013 116:1360-1363.

Pain is a big problem. If you read about pain management centres you might think it had been solved. It hasn’t. And when no effective treatment exists for a medical problem, it leads to a tendency to clutch at straws.  Research has shown that acupuncture is little more than such a straw.

Although it is commonly claimed that acupuncture has been around for thousands of years, it hasn’t always been popular even in China.  For almost 1000 years it was in decline and in 1822 Emperor Dao Guang issued an imperial edict stating that acupuncture and moxibustion should be banned forever from the Imperial Medical Academy.

Acupuncture continued as a minor fringe activity in the 1950s.  After the Chinese Civil War, the Chinese Communist Party ridiculed traditional Chinese medicine, including acupuncture, as superstitious.  Chairman Mao Zedong later revived traditional Chinese Medicine as part of the Great Proletarian Cultural Revolution of 1966 (Atwood, 2009).  The revival was a convenient response to the dearth of medically-trained people in post-war China, and a useful way to increase Chinese nationalism.  It is said that Chairman Mao himself preferred Western medicine. His personal physician quotes him as saying “Even though I believe we should promote Chinese medicine, I personally do not believe in it. I don’t take Chinese medicine” Li {Zhisui Li. Private Life Of Chairman Mao: Random House, 1996}.

The political, or perhaps commercial, bias seems to still exist. It has been reported by Vickers et al. (1998) (authors who are sympathetic to alternative medicine) that

"all trials [of acupuncture] originating in China, Japan, Hong Kong, and Taiwan were positive"(4).

Acupuncture was essentially defunct in the West until President Nixon visited China in 1972.  Its revival in the West was largely a result of a single anecdote promulgated by journalist James Reston in the New York Times, after he’d had acupuncture in Beijing for post-operative pain in 1971. Despite his eminence as political journalist, Reston had no scientific background and evidently didn’t appreciate the post hoc ergo propter hoc fallacy, or the idea of regression to the mean.

After Reston’s article, acupuncture quickly became popular in the West. Stories circulated that patients in China had open heart surgery using only acupuncture (Atwood, 2009). The Medical Research Council (UK) sent a delegation, which included Alan Hodgkin, to China in 1972 to investigate these claims , about which they were skeptical.  In 2006 the claims were repeated in 2006 in a BBC TV program, but Simon Singh (author of Fermat’s Last Theorem) discovered that the patient had been given a combination of three very powerful sedatives (midazolam, droperidol, fentanyl) and large volumes of local anaesthetic injected into the chest.  The acupuncture needles were purely cosmetic.

Curiously, given that its alleged principles are as bizarre as those on any other sort of pre-scientific medicine, acupuncture seemed to gain somewhat more plausibility than other forms of alternative medicine.  The good thing about that is that more research has been done on acupuncture than on just about any other fringe practice.

The outcome of this research, we propose, is that the benefits of acupuncture, if any, are too small and too transient to be of any clinical significance.  It seems that acupuncture is little or no more than a theatrical placebo.  The evidence for this conclusion will now be discussed.

Three things that are not relevant to the argument

There is no point in discussing surrogate outcomes such as fMRI studies or endorphine release studies until such time as it has been shown that patients get a useful degree of relief. It is now clear that they don’t.

There is also little point in invoking individual studies.  Inconsistency is a prominent characteristic of acupuncture research: the heterogeneity of results poses a problem for meta-analysis.  Consequently it is very easy to pick trials that show any outcome whatsoever.  Therefore we shall consider only meta-analyses.

The argument that acupuncture is somehow more holistic, or more patient-centred, than medicine seems us to be a red herring.  All good doctors are empathetic and patient-centred.  The idea that empathy is restricted to those who practice unscientific medicine seems both condescending to doctors, and it verges on an admission that empathy is all that alternative treatments have to offer.

There is now unanimity that the benefits, if any, of acupuncture for analgesia, are too small to be helpful to patients.

Large multicenter clinical trails conducted in Germany {Linde et al., 2005; Melchart et, 2005; Haake et al, 2007, Witt et al, 2005), and in the United States {Cherkin et al, 2009) consistently revealed that verum (or true) acupuncture and sham acupuncture treatments are no different in decreasing pain levels across multiple chronic pain disorders: migraine, tension headache, low back pain, and osteoarthritis of the knee.

If, indeed, sham acupuncture is no different from real acupuncture the apparent improvement that may be seen after acupuncture is merely a placebo effect.  Furthermore it shows meridians don’t exist, so the "theory" memorized by qualified acupuncturists is just myth. All that remains to be discussed is whether or not the placebo effect is big enough to be useful, and whether it is ethical to prescribe placebos.

Some recent meta-analyses have found that there may be a small difference between sham and real acupuncture.  Madsen Gøtzsche & Hróbjartsson {2009) looked at thirteen trials with 3025 patients, in which acupuncture was used to treat a variety of painful conditions.  There was a small difference between ‘real’ and sham acupuncture (it didn’t matter which sort of sham was used), and a somewhat bigger difference between the acupuncture group and the no-acupuncture group.  The crucial result was that even this bigger difference corresponded to only a 10 point improvement on a 100 point pain scale.  A consensus report (Dworkin, 2009) that a change of this sort should be described as a “minimal” change or “little change”.  It isn’t big enough for the patient to notice much effect.

The acupuncture and no-acupuncture groups were, of course, not blind to the patients and neither were they blind to the practitioner giving the treatment.  It isn’t possible to say whether the observed difference is a real physiological action or whether it’s a placebo effect of a rather dramatic intervention.  Interesting though it would be to know this, it matters not a jot, because the effect just isn’t big enough to produce any tangible benefit.

Publication bias is likely to be an even greater problem for alternative medicine than it is for real medicine, so it is particularly interesting that the result just described has been confirmed by authors who practise, or sympathise with, acupuncture.  Vickers et al. (2012) did a meta-analysis for 29 RCTs, with 17,922 patients.  The patients were being treated for a variety of chronic pain conditions. The results were very similar to those of Madsen et al.{2009).  Real acupuncture was better than sham, but by a tiny amount that lacked any clinical significance.  Again there was a somewhat larger difference in the non-blind comparison of acupuncture and no-acupuncture, but again it was so small that patients would barely notice it.

Comparison of these two meta-analyses shows how important it is to read the results, not just the summaries.  Although the outcomes were similar for both, the spin on the results in the abstracts (and consequently the tone of media reports) was very different.

An even more extreme example of spin occurred in the CACTUS trial of acupuncture for " ‘frequent attenders’ with medically unexplained symptoms” (Paterson et al., 2011).  In this case, the results showed very little difference even between acupuncture and no-acupuncture groups, despite the lack of blinding and lack of proper controls.  But by ignoring the problems of multiple comparisons the authors were able to pick out a few results that were statistically significant, though trivial in size.  But despite this unusually negative outcome, the result was trumpeted as a success for acupuncture.  Not only the authors, but also their university’s PR department and even the Journal editor issued highly misleading statements.  This gave rise to a flood of letters to the British Journal of General Practice and much criticism on the internet.

From the intellectual point of view it would be interesting to know if the small difference between real and sham acupuncture found in some, but not all, recent studies is a genuine effect of acupuncture or whether it is a result of the fact that the practitioners are never blinded, or of publication bias.  But that knowledge is irrelevant for patients. All that matters for them is whether or not they get a useful degree of relief.

There is now unanimity between acupuncturists and non-acupuncturists that any benefits that may exist are too small to provide any noticeable benefit to patients.  That being the case it’s hard to see why acupuncture is still used.  Certainly such an accumulation of negative results would result in the withdrawal of any conventional treatment.

Specific conditions

Acupuncture should, ideally, be tested separately for effectiveness for each individual condition for which it has been proposed (like so many other forms of alternative medicine, that’s a very large number).  Good quality trials haven’t been done for all of them.  It’s unlikely that acupuncture works for rheumatoid arthritis, stopping smoking, irritable bowel syndrome or for losing weight.  And there is no good reason to think it works for addictions, asthma, chronic pain, depression, insomnia, neck pain, shoulder pain or frozen shoulder, osteoarthritis of the knee, sciatica, stroke or tinnitus and many other conditions (Ernst et al., 2011).

In 2009, the UK’s National Institute for Clinical Excellence (NICE) did recommend both acupuncture and chiropractic for back pain. This exercise in clutching at straws caused something of a furore.  In the light of NICE’s judgement the Oxford Centre for Evidence-based medicine updated its analysis of acupuncture for back pain.  Their verdict was

“Clinical bottom line. Acupuncture is no better than a toothpick for treating back pain.”

The paper by Artus et al. (2010) is of particular interest for the problem of back pain.  Their Fig 2 shows that there is a modest improvement in pain scores after treatment, but much the same effect, with the same time course is found regardless of what treatment is given, and even with no treatment at all.  They say

“we found evidence that these responses seem to follow a common trend of early rapid improvement in symptoms that slows down and reaches a plateau 6 months after the start of treatment, although the size of response varied widely. We found a similar pattern of improvement in symptoms following any treatment, regardless of whether it was index, active comparator, usual care or placebo treatment”.

It seems that most of what’s being seen is regression to the mean. And that is very likely to be the main reason why acupuncture sometimes appears to work when it doesn’t.

Although the article by Wang et al (2012) was written to defend the continued use of acupuncture, the only condition for which they claim that there is any reasonably strong evidence is for post-operative nausea and vomiting (PONV).  It would certainly be odd if a treatment that had been advocated for such a wide variety of conditions turned out to work only for PONV.  Nevertheless, let’s look at the evidence.

The main papers that are cited to support the efficacy of acupuncture in alleviation of PONV are all from the same author: Lee & Done (1999), and two Cochrane reviews, Lee & Done (2004), updated in Lee & Fan (2009).  We need only deal with this latest updated meta-analysis.

Although the authors conclude “P6 acupoint stimulation prevented PONV”, closer examination shows that this conclusion is very far from certain.  Even taken at face value, a relative risk of 0.7 can’t be described as “prevention”.  The trials that were included were not all tests of acupuncture but included several other more or less bizarre treatments (“acupuncture, electro-acupuncture, transcutaneous nerve stimulation, laser stimulation, capsicum plaster, an acu-stimulation device, and acupressure”).  The number needed to treat varied from a disastrous 34 to a poor 5 for patients with control rates of PONV of 10% and 70% respectively.

The meta-analysis showed, on average, similar effectiveness for acupumcture and anti-emetic drugs.  The problem is that the effectiveness of drugs is in doubt because an update to the Cochrane review has been delayed (Carlisle, 2012) by the discovery of major fraud by a Japanese anesthetist, Yoshitaka Fujii (Sumikawa, 2012). It has been suggested that metclopramide barely works at all (Bandolier, 2012; Henzi, 1999).

Of the 40 trials (4858 participants) that were included; only four trials reported adequate allocation concealment. Ninety percent of trials were open to bias from this source. Twelve trials did not report all outcomes.  The opportunities for bias are obvious. The authors themselves describe all estimates as being of “Moderate quality” which is defined this:Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate”.  That being the case, perhaps the conclusion should have been “more research needed”.  In fact almost all trials of alternative medicines seem to end up with the conclusion that more research is needed.

Conclusions

It is clear from meta-analyses that results of acupuncture trials are variable and inconsistent, even for single conditions.  After thousands of trials of acupuncture, and hundreds of systematic reviews (Ernst et al., 2011), arguments continue unabated.  In 2011, Pain carried an editorial which summed up the present situation well.

“Is there really any need for more studies? Ernst et al. (2011) point out that the positive studies conclude that acupuncture relieves pain in some conditions but not in other very similar conditions. What would you think if a new pain pill was shown to relieve musculoskeletal pain in the arms but not in the legs? The most parsimonious explanation is that the positive studies are false positives. In his seminal article on why most published research findings are false, Ioannidis (2005) points out that when a popular but ineffective treatment is studied, false positive results are common for multiple reasons, including bias and low prior probability.”

Since it has proved impossible to find consistent evidence after more than 3000 trials, it is time to give up.  It seems very unlikely that the money that it would cost to do another 3000 trials would be well-spent.

A small excess of positive results after thousands of trials is most consistent with an inactive intervention.  The small excess is predicted by poor study design and publication bias. Further, Simmons et al (2011) demonstrated that exploitation of "undisclosed flexibility in data collection and analysis" can produce statistically positive results even from a completely nonexistent effect.  With acupuncture in particular there is documented profound bias among proponents (Vickers et al., 1998).  Existing studies are also contaminated by variables other than acupuncture – such as the frequent inclusion of "electroacupuncture" which is essentially transdermal electrical nerve stimulation masquerading as acupuncture.

The best controlled studies show a clear pattern – with acupuncture the outcome does not depend on needle location or even needle insertion. Since these variables are what define "acupuncture" the only sensible conclusion is that acupuncture does not work. Everything else is the expected noise of clinical trials, and this noise seems particularly high with acupuncture research. The most parsimonious conclusion is that with acupuncture there is no signal, only noise.

The interests of medicine would be best-served if we emulated the Chinese Emperor Dao Guang and issued an edict stating that acupuncture and moxibustion should no longer be used in clinical practice.

No doubt acupuncture will continue to exist on the High Streets where they can be tolerated as a voluntary self-imposed tax on the gullible (as long as they don’t make unjustified claims).

 REFERENCES 1. Acupuncture Centre. . About Acupuncture. Available at: http://www.acupuncturecentre.org/aboutacupuncture.html. Accessed March 30, 2013 2. Atwood K. “Acupuncture Anesthesia”: a Proclamation from Chairman Mao (Part IV). Available at: http://www.sciencebasedmedicine.org/index.php/acupuncture-anesthesia-a-proclamation-from-chairman-mao-part-iv/. Accessed September 2, 2012 3. Li Z Private Life of Chairman Mao: The Memoirs of Mao’s Personal Physician. 1996 New York: Random House 4. Vickers A, Goyal N, Harland R, Rees R. Do certain countries produce only positive results? A systematic review of controlled trials. Control Clin Trials. 1998;19:159–66 Available at: http://bit.ly/WqVGWN. Accessed September 2, 2012 5. Reston J. Now, About My Operation in Peking; Now, Let Me Tell You About My Appendectomy in Peking … The New York Times. 1971 Available at: http://select.nytimes.com/gst/abstract.html?res=FB0D11FA395C1A7493C4AB178CD85F458785F9. Accessed March 30, 2013 6. Atwood K. “Acupuncture anesthesia”: a proclamation from chairman Mao (part I). Available at: http://www.sciencebasedmedicine.org/index.php/acupuncture-anesthesia-a-proclamation-of-chairman-mao-part-i/. Accessed September 2, 2012 7. Linde K, Streng A, Jürgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for patients with migraine: a randomized controlled trial. JAMA. 2005;293:2118–25 8. Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Hummelsberger J, Irnich D, Weidenhammer W, Willich SN, Linde K. Acupuncture in patients with tension-type headache: randomised controlled trial. BMJ. 2005;331:376–82 9. Haake M, Müller HH, Schade-Brittinger C, Basler HD, Schäfer H, Maier C, Endres HG, Trampisch HJ, Molsberger A. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 2007;167:1892–8 10. Witt C, Brinkhaus B, Jena S, Linde K, Streng A, Wagenpfeil S, Hummelsberger J, Walther HU, Melchart D, Willich SN. Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet. 2005;366:136–43 11. Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med. 2009;169:858–66 12. Madsen MV, Gøtzsche PC, Hróbjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ. 2009;338:a3115 13. Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009;146:238–44 14. Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012;172:1444–53 15. Paterson C, Taylor RS, Griffiths P, Britten N, Rugg S, Bridges J, McCallum B, Kite G. Acupuncture for ‘frequent attenders’ with medically unexplained symptoms: a randomised controlled trial (CACTUS study). Br J Gen Pract. 2011;61:e295–e305 16. . Letters in response to Acupuncture for ‘frequent attenders’ with medically unexplained symptoms. Br J Gen Pract. 2011;61 Available at: http://www.ingentaconnect.com/content/rcgp/bjgp/2011/00000061/00000589. Accessed March 30, 2013 17. Colquhoun D. Acupuncturists show that acupuncture doesn’t work, but conclude the opposite: journal fails. 2011 Available at: http://www.dcscience.net/?p=4439. Accessed September 2, 2012 18. Ernst E, Lee MS, Choi TY. Acupuncture: does it alleviate pain and are there serious risks? A review of reviews. Pain. 2011;152:755–64 19. Colquhoun D. NICE falls for Bait and Switch by acupuncturists and chiropractors: it has let down the public and itself. 2009 Available at: http://www.dcscience.net/?p=1516. Accessed September 2, 2012 20. Colquhoun D. The NICE fiasco, part 3. Too many vested interests, not enough honesty. 2009 Available at: http://www.dcscience.net/?p=1593. Accessed September 2, 2012 21. Bandolier. . Acupuncture for back pain—2009 update. Available at: http://www.medicine.ox.ac.uk/bandolier/booth/painpag/Chronrev/Other/acuback.html. Accessed March 30, 2013 22. Artus M, van der Windt DA, Jordan KP, Hay EM. Low back pain symptoms show a similar pattern of improvement following a wide range of primary care treatments: a systematic review of randomized clinical trials. Rheumatology (Oxford). 2010;49:2346–56 23. Wang S-M, Harris RE., Lin Y-C, Gan TJ. Acupuncture in 21st century anesthesia: is there a needle in the haystack? Anesth Analg. 2013;116:1356–9 24. Lee A, Done ML. The use of nonpharmacologic techniques to prevent postoperative nausea and vomiting: a meta-analysis. Anesth Analg. 1999;88:1362–9 25. Lee A, Done ML. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2004:CD003281 26. Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2009:CD003281 27. Carlisle JB. A meta-analysis of prevention of postoperative nausea and vomiting: randomised controlled trials by Fujii etal. compared with other authors. Anaesthesia. 2012;67:1076–90 28. Sumikawa K. The results of investigation into Dr.Yoshitaka Fujii’s papers. Report of the Japanese Society of Anesthesiologists Special Investigation Committee. http://www.anesth.or.jp/english/pdf/news20120629.pdf 29. Bandolier. . Metoclopramide is ineffective in preventing postoperative nausea and vomiting. Available at: http://www.medicine.ox.ac.uk/bandolier/band71/b71-8.html. Accessed March 30, 2013 30. Henzi I, Walder B, Tramèr MR. Metoclopramide in the prevention of postoperative nausea and vomiting: a quantitative systematic review of randomized, placebo-controlled studies. Br J Anaesth. 1999;83:761–71 31. Hall H. Acupuncture’s claims punctured: not proven effective for pain, not harmless. Pain. 2011;152:711–2 32. Ioannidis JP. Why most published research findings are false. PLoS Med. 2005;2:e124 33. Simmons JP, Leif DN, Simonsohn U. False-positive psychology: undisclosed flexibility in data collection and analysis allows presenting anything as significant. Psychol Sci. 2011;22:1359–66

### Follow-up

30 May 2013 Anesthesia & Analgesia has put the whole paper on line. No paywall now!

## The election of Prince Andrew to the Royal Society. What Fellows think.

#### May 25th, 2013 · 9 Comments

A recent post, A right royal cock-up, got a lot more press attention than I’d expected. Perhaps I should have realised that the mainstream media are fascinated with anything that involves royalty. Here is my last word on that topic.

My reasons for writing about it had very little to do with royalty. I was elected to the Royal Society in 1985 and I’ve tolerated the odd voting forms, and the election of Royal Fellows, in silence for the last 27 years. What made me speak out this time was almost entirely to do with Andrew’s record of dubious behaviour. For me, it was a moral question, not a question of royalty per se.

The election of Prince Andrew (as a "Royal Fellow", not on scientific grounds) attracted 171 votes and 1128 non-responders. I was curious to know why so many people failed to vote. I was also curious about the statement made to the Sunday Times

"David’s [Colquhoun] views about our royal connections are very much in a minority"

Since I don’t recall being asked, I’m baffled about what data (if any) on which that statement was based. There was only one way to find out. To ask. The following email was sent at around 5 pm on Friday 17 May.

 Subject: A very quick question about the election of Royal Fellows In the light of the recent publicity surrounding the “election” of Prince Andrew as a Royal Fellow, I thought that, because so few people voted, it would be interesting to know the views of all fellows on this tradition.  This mail is being sent to the 1197 fellows whose email address is given in the Year Book. All you need to do is to hit reply and put YES or NO next to the following two questions. Only the total numbers are interesting. I promise not to reveal how anyone voted.  1) Do you think that the time has come to discontinue the tradition of electing Royal Fellows?  2) Do you think the election of Prince Andrew, in particular, has harmed the reputation of the Royal Society? NB  These questions do not refer to the monarch as patron (but if you have an opinion about that. please say so). Best regards David Colquhoun

The intention was to word it as neutrally as possible. Few people expressed an opinion about the monarch as patron. I see no harm in continuing that tradition myself.

What happened?

First, the Year Book is out of date. 106 emails bounced, several were "out of office", and a few recipients had died. So about 1080 emails should have arrived. I have no way of knowing how many were opened and read.

After one week, 324 replies had arrived, almost twice as many as the 171 votes cast in the original ballot. A couple of responses were surprisingly abusive. More were supportive. Most made no comment. 70% of those mailed didn’t respond. The 30% return rate is certainly a flaw, tnough not as big a flaw as the 13% return rate in the orginal poll,

Perhaps 30% isn’t so surprising. A weekly newsletter goes out to all UCL staff, and it has interesting information, though a bit too PR-like for my taste. But I’m told that 50% of emails sent out are never even opened, never mind read.

The results were as follows.

Of 302 who answered question 1, 131 (43%) said YES

Of 284 who answered question 2, 151 (53%) said YES

It was noticeable that those who work outside the UK were distinctly more likely to say NO. Perhaps they are unaware of the extensive press coverage about Andrew in the UK? 54 answers were received from people with .edu addresses, 32% yes for question 1, and 38% yes on question 2. If these are excluded on the grounds that they are unlikely to be aware of the problems, the results are

Of 248 who answered question 1, 114 (46%) said YES

Of 239 who answered question 2, 134 (56%) said YES

It might also be relevant almost half the fellows are 70 years old or older and 80% of fellows are 60 or older. That’s not surprising because very few people are elected at younger than 40, many are much older, and once in, you are in for life.

What can we conclude?

(1) 70% of those mailed have little interest in the politics of the RS, and there is no way to know whether they even opened my mail,

(2) Roughly half of those who expressed an opinion agreed with me

so

(3) it is not true that "David’s [Colquhoun] views about our royal connections are very much in a minority".

It seems to me that these numbers provide a good case for the RS Council to consider whether or not it is a good idea to continue to nominate Royal Fellows.

One more thing

The Sunday Times was also told

"The Duke of York is beloved by the tabloids but he has always had a robust defence in these issues . . . I think David is quite wrong to raise that"

It is most certainly not true that Andrew’s reputation is bad only in tabloid newspapers.

Try this leader in the Times (March 2011) “Undiplomatic Envoy. Prince Andrew’s friendship with a convicted US financier is an embarrassment. He should resign as a trade envoy“. [pdf]There are many more reports like that in the Times.

The most royalist of Conservative broadsheets, the Daily Telegraph, broke the story of abuse of aircraft and published Timeline: the Duke of York’s questionable friends. And the Telegraph’s chief reporter wrote "Sack the Duke of York as trade envoy, says former ambassador". And in 2012, the Telegraph wrote "Money laundering probe puts spotlight on the £15 million sale of the Duke of York’s home"

In March 2011, Channel 4 News wrote “Prince Andrew: ‘Cheerleader in chief for the arms industry

The Guardian has been critical since 2004. And of course it was the Guardian who published  the cables  that revealed Andrew’s curious attitude to bribery in arms deals.

These are not tabloids. The fact that every newspaper has written this sort of thing is what caused me to worry that his election would not go down well with the public. One of the most alarming aspects of the affair was the comments left by readers on the various newspaper articles. They did not give the impression that the public was as impressed by the Royal Society as its fellows tend to be. That is bad for everyone because the society does much good work, in funding science (in particular the excellent University Research Fellowships which give young scientists five years of independence).

Postscript

I do sometimes wonder about the value of prizes and honours. My attitude to them is very much like that of one of my great scientific heroes, Richard Feynman. Watch this.

### Follow-up

26 May 2013 The Sunday Times was onto the story quickly again, with a short piece. The cartoon isn’t totally appropriate (for me) since I’ve said repeatedly that it is Andrew’s morals that worry me, far more than his royalty.

## A curious letter from David Tredinnick MP, the government’s resident medical loon

#### May 15th, 2013 · 3 Comments

It’s hard to know what to make of  David Tredinnick MP (Cons, Bosworth). He is certainly an extreme example of the scientific ignorance of our parliamentary representatives, but he isn’t alone in that. Our present minister of Education, Michael Gove, memorably referred to Newton’s Laws of Thermodynamics, blissfully unaware that thermodynamics was a 19th century development. And our present Minister of Health seems to think that magic water cures diseases.

But Mr Treddinick breaks every record for anti-scientific nonsense. That, no doubt, is why he was upset by the recent revision of come NHS Choices web pages, so that they now give a good account of the evidence (that’s their job, of course). They did that despite two years of obstruction by the Department of Health. which seemed to think that it was appropriate to take advice from Michael Dixon of the Prince’s Foundation for integrated Health. That shocking example of policy based evidence was revealed on this blog, and caused something of a stir.

Treddinick’s latest letter

A copy of a letter from Mr Tredinnick to the Minister of Health, Jeremy Hunt, has some into my possession by a tortuous route [download the letter]. It’s a corker. Here are a few quotations.

"1. UKIP moving onto our ground
Attached is an extract from a recent UKIP policy statement. The position which UKIP has taken is one with which most of our Daily Mail reading supporters of complementary medicine would agree."

It seems that Treddinick’s preferred authority on medicine is now Nigel Farage, leader of the UK’s far right party. UKIP’s policy on health is appended to the letter, and it’s as barmy as most of the other things they say.

"2. Herbal Medicine
. . .there is very real concern that the Government will not regulate Herbal Medicine and Traditional Chinese Medicine. The current situation is unacceptable, because herbal practitioners need regulation and cannot function as herbal therapists, nor can they cannot obtain stocks of their herbal remedies, without it.

This refers to a saga that has been running for at least 10 years. Herbalists are desperate to get a government stamp of approval by getting statutory regulation, much like real doctors have, despite the fact that they make money by selling sick people "an unknown dose of an ill-defined drug, of unknown effectiveness and unknown safety" (as quoted recently in the House of Lords).

Even  the US National Center for Complementary and Alternative Medicine (NCCAM) doesn’t claim that a single herbal treatment is useful. The saga of herbal regulation is long and tedious. The short version is that a very bad report, The Pittilo report, recommended regulation of herbalists. After years of prevarication, Andrew Lansley ignored the impartial scientific advice and yielded to the pressure from the herbal industry to accept the Pittilo report. But still nothing has happened.

Could it be that even Jeremy Hunt realises, deep down, that the regulation of nonsense is a nonsense that would harm the public?

We can only hope that a letter from Mr Tredinnick is the kiss of death. Perhaps his continuous pestering will only reinforce the doubts that seem to exist at the Department of Health.

Then Tredinnick returns (yawn) to his obsession with magic water. He vents his rage at the now excellent NHS Choices page on homeopathy.

3. Homeopathy

"Recently this wording has been removed and instead a comment by the Chief Medical Officer that homeopathy is placebo inserted in its place, as well as links to external organisations which campaign against homeopathy. For instance, there is a link to the Sense About Science website, and Caroline Finucane, who is Editor of new content at NHS Choices, also writes for the Sense About Science website. This is an organisation which has no expertise in homeopathy and traces its roots back to the ultra-left Revolutionary Communist Party (RCP)."

"I respectfully suggest that the original wording be reinstated and these links to external organisations be removed or changed to ensure a balanced view.".

So it seems that he prefers the medical views of Nigel Farage and the Prince of Wales to those of the Chief Medical Officer and the government’s chief scientist. Disgracefully, Tredinnick picks out one particular employee of NHS Choices among many, and one who does an excellent job. And he raises the hoary old myth that Sense About Science is a communist organisation. Odd, since others accuse it of being neo-libertarian. The actual history is here. The organisation that is a bit too libertarian for my taste is Spiked Online. I haven’t agreed with every word that Sense about Science has printed, but they have a totally honest belief in evidence.

To drag in the name of one person out of many, and to justify it by a false history shows, once again, how very venomous and vindictive the advocates of delusional medicine can be when they feel cornered.

This is what the BBC News profile says about him.

 David Tredinnick is an old style Conservative MP, being an Eton-educated former Guards officer, who has sat in the Commons since 1987. However, his ambition for high office was thwarted by his role in one of the sleaze stories which helped to sink the Major government. He accepted £1,000 from an undercover reporter to ask parliamentary questions about a fictitious drug. He was obliged to resign from his role as a PPS and was suspended from the Commons for 20 sitting days. He has not sat on the frontbench since. He is an orthodox Conservative loyalist, though he is more supportive of the European Union than many of his colleagues. He has, however, carved himself a niche as the Commons’ most enthusiastic supporter of complementary medicine. He has wearied successive health secretaries with his persistent advocacy of any and all homeopathic remedies. He has also supported their use in prisons and even suggested them as an aid in alleviating the foot and mouth crisis.

 Tredinnick has also asserted that he was aware of a psychiatric hospital that doubled its staff at full moon (this is an old urban myth, and is, of course, quite untrue). His advocacy of homeopathic borax as a way to control the 2001 epidemic of foot and mouth diease can be read here. Luckily it was ignored by the government. I hope his latest letter will be treated similarly. Picture of David Tredinnick MP from the Conservative Party

## A right Royal cock-up. Prince Andrew elected to the Royal Society

#### May 3rd, 2013 · 26 Comments

Today the Royal Society elected Andrew, Duke of York, as a “Royal Fellow”. Well, to be exact. 11% of them did. The numbers, which the Society has not made public, were as follows (as fraction of the electorate, 1300 Fellows)

Yes                                  147     (11%)
No                                   24        (2%)
Blank ballot                       1       (0.08%)
Failed to vote              1128      (87%)

Hardly resounding support, then.

When I heard that the Society’s Council had nominated the Duke of York, I was sufficiently outraged to write a piece along the lines below. I was thinking about breaking the rules and going public with it before the election. I’m not particularly republican, but I do think that the Royal family still have too much influence on politics (as well as pernicious social effects).

On Monday 8th April I discussed the matter with the president, Paul Nurse. He was charm itself, but he didn’t explain what the advantages to the society were, and he didn’t agree to my proposal to mail my views to all Fellows. It seems odd that fellows have no way to communicate with each other , but that is how it is. But he did agree to set up an internal web site where Fellows could discuss the nomination in private. Most of them didn’t bother, but those who did were unanimous in supporting my views, apart from three members of Council, which had nominated him. Some people think that it is better to not to air disagreements in public. I don’t agree. I think it should be known that few people voted for this move. So here is what I wrote,

A curious fellow

The Royal Society has, on the whole, some pretty bright Fellows.  It’s been around for 360 years and that, no doubt, is why it also has some quaintly archaic customs.  One of them is the election of “Royal Fellows”.  They are described as “Members of the Society by virtue of royal blood”, though ‘royal blood’ is a curiously unscientific idea.

The Royal Society was founded in 1660, and was granted a royal charter by Charles 2nd.  The Society was a manifestation of the age of enlightenment.  It might be seen as a harmless eccentricity that one of the present royal fellows said that he was rather proud to have been accused of being an enemy of the enlightenment.  That, of course, was the Prince of Wales (known affectionately in the blogosphere as the Quacktitioner Royal).

The Royal Society was founded to advocate the idea that observation was what mattered, not deference to authority.  The exception to that seems to be deference to “royal blood”.

But I believe it is taking deference too far to elect Prince Andrew.  Not believing in science is one thing.  Accusations of bribery and corruption in the sales of arms to dictators are quite another.  From the leak of US diplomatic cables in 2010 we know, through cables from the US Ambassador to Kyrgyzstan, some unsavoury facts.  During discussions of bribery in Kyrgyzstan and the investigation into the Al-Yamamah arms deal, the Duke “railed at British anti-corruption investigators, who had had the "idiocy" of almost scuttling the Al-Yamama deal with Saudi Arabia”. He was talking about kickbacks to a senior Saudi royal had allegedly received in exchange for a huge arms contract with BAE Systems.  The cable went on "He then went on to ‘these (expletive) journalists, especially from the National [sic] Guardian, who poke their noses everywhere’ and (presumably) make it harder for British businessmen to do business. The crowd practically clapped!".  There could hardly be stronger evidence that bribery to sell arms had the approval of the Duke of York. The affair was hushed up when Tony Blair’s government shut down the investigation into the affair by the Serious Fraud Office, but the head of the SFO said that the decision to stop the investigation may have damaged "the reputation of the UK as a place which is determined to stamp out corruption". The USA was less squeamish.  A judge said that BAE’s conduct involved "deception, duplicity and knowing violations of law, I think it’s fair to say, on an enormous scale".   This is what the Duke of York was so eager to hide from the eyes of “these (expletive) journalists”.

Earlier in 2010 it was discovered that the billionaire son-in-law of Kazakhstan’s President paid the Duke of York’s representatives £15m via offshore companies, for the Duke’s mansion, Sunninghill Park. That was investigated by prosecutors  in Italy and Switzerland.

It doesn’t end there.  In 2011 the Duke of York got yet more bad press after revelation of his close friendship with Jeffrey Epstein, who was convicted in Florida for soliciting an underage girl for prostitution.  In July 2011, the Duke’s role as a trade representative was ended.

As recently as 2012, the Duke was criticised for his close friendship with the president of Azerbaijan, Ilham Aliyev, who is regarded as one of the most brutal and corrupt rulers in the world.  By this time, Prince Andrew had He lost the support of even the most Royalist newspapers.

A record like that makes the Duke of York an unsuitable person to be a member of any club, never mind election as a fellow of the Royal Society.

There is one section of society which regards scientists as amoral automatons, willing to shut their eyes to wrongdoing if it is in their own interest to do so. I have met very few such people, but the election of Prince Andrew can only reinforce that view.

The citation sent to me by the Royal Society mentioned none of his unsavoury history.  It referred only to the ‘benefits’ that election would have for the Society. What exactly these benefits are has never been explained. They seem to amount to chairing a few meetings and dinners. Many of us would prefer not to have dinner with him. The nomination was a good example of that prime scientific crime, cherry-picking the evidence.

The proposal was accompanied by a ballot form. The form had a single box, labelled “I support the election of HRH the Duke of York KG GCVO as a Royal Fellow of the Royal Society”.

That’s the sort of ballot form used for senior posts in the Royal Society.  It would be popular in Kazakhstan or Saudi Arabia.

### Follow-up

5 May 2013. The Sunday Times was on to this story quickly, and it was on their front page.

The story [download pdf] quotes past president Robert May, and Peter Lawrence (prof of Molecular Biology, LMB, Cambridge) who supported my views.

5 May 2013. I had the best laugh for years when I read the post by James Wilsdon who is now professor of science and democracy at the University of Sussex, but was previously director of science policy at the Royal Society, so he has had an inside view. His post makes mine look gentle.

"But now, Prince Andrew has been invited into the Royal Society’s ranks. And a fair number of his fellow Fellows aren’t happy. First off the blocks was David Colquhoun, UCL’s most famous pipe-smoking pharmacologist, who on Friday launched a full-frontal attack on his blog on what he called a “right Royal cock-up”. And today, the story has hit the front pages of the Sunday Times, with even the society’s former president, Bob May, reportedly “dismayed” over Andrew’s election. "

"Controversy surrounding his role as a UK trade envoy, and his equally unsavoury association with a convicted US sex offender led to him resigning his role as “Airmiles Andy” in July 2011. Ministers and senior officials within the Foreign Office privately breathed a sigh of relief.

It was around this time that Prince Andrew started popping up more regularly at Royal Society events, offering to chair meetings and lend his support. (I was still working there at the time as director of science policy). The sensible response would have been to steer well clear, but as I witnessed at first hand, for such an incredibly clever bunch of people, elected themselves on merit (the very antithesis of hereditary royal privilege) many fellows of the Royal Society were susceptible to feudal levels of swooning at the merest flash of royal ermine. The centrepiece of its 350th anniversary celebrations in 2010 was an orgy of obsequiousness at the Festival Hall, with no fewer than seven Royals and 2000 guests in attendance to see Prince William receive his Royal Fellowship (no doubt for his outstanding services to art history, geography and steering helicopters)."

"Full credit to David Colquhoun for shining a light into one of the darker recesses of the scientific establishment. Of course, defenders of the decision will point out that this is the “Royal” Society, and a bit of old-fashioned bowing and scraping is part of its unique British charm. But there are plenty of equally prestigious institutions with a rich royal history that have modernised those networks of patronage, and aren’t spending the 21st century with their heads rammed quite so firmly up the Windsor arse. Nullius in verba, old chaps, nullius in verba…"

As we say in the blogosphere, ROFL.

The Guardian had a lot of coverage too. James Wilsdons piece appeared also in Guardian blogs: Royal society row over election of Prince Andrew as fellow. There is also a piece on the same topic by Peter Walker, “Royal Society scientists angered by Prince Andrew’s election as fellow“.

6 May 2013. There is an account in the Daily Mail by Nick Fagge. I won’t link to it because it is a shameless cut and paste job from the Sunday Times, with several mistakes added. The Mail at its worst.

The Independent asked for an op-ed column from me on Sunday. It appeared the next day. Mostly it was a shortened version of this blog, with the links removed (I wish they wouldn’t do that). But I did get in a comment that I often make in private.

“Certainly monarchs in recent times have shown little interest in science. If I wanted a tip for the winner of the 14.30 at Newmarket, I’d ask a royal. For most other questions, I wouldn’t.”

The Independent also carried a piece by Kate Morris on the same topic.

The Times had an interesting piece, by Hannah Devlin. They quote James Wilsdon

“James Wilsdon, Professor of Science and Democracy at the University of Sussex and formerly head of policy at the Royal Society, described the appointment on Twitter as “needless establishment toadying”. “Plenty of institutions with a royal history that aren’t spending the 21st century with their heads lodged quite so firmly up the Windsor a***,” he tweeted yesterday.”

and

“Richard Horton, editor of the medical journal The Lancet said that the decision to “grovel to royal patronage” was an “embarrassment for science” and “symptomatic of Britain’s corrupt honours system”.”

The Financial Times had a short report too.

International coverage

The story quickly went international. Stories appeared in the Gulf Times, the Economic Times, the Statesman (India), the Kashmir Times, the Indian Express

USA News Online reproduced both the Guardian article and James Wilsdon’s feisty piece in the Guardian.

7 May 2013

There is a report today in Paris MatchAndrew trop Royal pour la Royal Society

8 May 2013.

Alice Thomson writes in the Times "One more reform for the Queen: her family. She needs to streamline ‘the Firm’, especially when the Royal Society treats a minor royal with absurd deference".

Here are a few quotations.

"Yet the Fellows (or rather 11 per cent of these illustrious academics) have elected the grand young Duke of York to their number, a man who may have many hidden talents but who paddles at the shallower end of the intellectual pool."

"it seems extraordinary that they have elected a minor member of the Royal Family who once piloted helicopters and knows more about golf than genomes.

The RS is obviously royal as well as a society but they already have Prince Philip, the Prince of Wales, the Princess Royal and Prince William. Any more and they will start looking like the Sandringham Christmas shoot. They stopped electing prime ministers after Margaret Thatcher but seem incapable of excluding the fourth in line to the throne.

This makes the Fellows appear antiquated and obsequious; but the bigger problem is what to do with these minor Royals."

"But his tenure as special trade envoy has not been a success. He managed to turn the fairytale of the Princess and the Pea into the nightmare of the Prince and the Paedophile when he befriended the sex offender Jeffrey Epstein. "

"No 10 increasingly don’t know what to do with him. “No one knows whether to bow, shake his hand or quietly slip out of the room when he arrives,” says one minister. The Queen tried to make amends by bestowing on him the Knight Grand Cross of the Royal Victorian Order, which allows him to wear a red, white and blue sash. "

"The Royal Society was set up as a manifestation of the age of enlightenment. Nearly 360 years later, we should be enlightened enough to enjoy our constitutional monarchy — but we should not be bowing and scraping to the minor players in the Royal Family. They should have retired from the national stage long ago."

This all seems very sensible to me. Incidentally, Alice Thomson is great-granddaughter of the famous physicist, J. J. Thomson, who was president of the Royal Society from 1915 to 1920.

10 May 2013 The affair has even reached Have I Got News for You. Here is the clip.

The Daily Mirror also weighed in, in fine tabloid style

Cack Andy-ed

The Royal Society, Britain’s top scientists’ club, has elected Prince Andrew a member.

Why? Nobody would ever accuse the Duke of York of being an intellectual. He’s as dim as a Toc H lamp.

The ballot paper permitted only a “Yes” vote, and 90% of members declined to back him.

A right royal farce. Only really clever people could make such common fools of themselves.

The nation’s best brains should stop tugging their forelock and drop “royal” from their title.

The royals don’t know a ­hypotenuse from a hyphen. Why not just call it The Science Society?

An interview on Voice of Russia Listen here

## Another update. Red meat doesn’t kill you, but the spin is fascinating

#### April 13th, 2013 · 3 Comments

The latest news: eating red meat doesn’t do any harm. But why isn’t that said clearly? Alarmism makes better news, not only for journalists but for authors and university PR people too.

In May 2009 Diet and health. What can you believe: or does bacon kill you? based on the WCRF report (2007).

In March 2012 How big is the risk from eating red meat now? An update.

In the first of these I argued that the evidence produced by the World Cancer Research Fund (WCRF) for a causal relationship was very thin indeed. An update by WCRF in 2010 showed a slightly smaller risk, and weakened yet further the evidence for causality, though that wasn’t reflected in their press announcement.

The 2012 update added observations from two very large cohort studies. The result was that the estimates of risk were less than half as big as in 2009. The relative risk of dying from colorectal cancer was 1.21 (95% Confidence interval 1.04–1.42) with 50 g of red or processed meat per day, whereas in the new study the relative risk for cancer was only 1.10 (1.06-1.14) for a larger ‘dose’, 85 g of red meat. Again this good news was ignored and dire warnings were issued.

This reduction in size of the effect as samples get bigger is exactly what’s expected for spurious correlations, as described by Ioannidis and others. And it seems to have come true. The estimate of the harm done by red meat has vanished entirely in the latest study.

The EPIC study

This is the European Prospective Investigation into Cancer and Nutrition, another prospective cohort study, so it isn’t randomised [read the original paper]. And it was big, 448,568 people from ten different European countries. These people were followed for a median time of 12.7 years, and during follow-up 26,344 of them died.

The thing that was different about this paper was that red meat was found to pose no detectable risk, as judged by all-cause mortality. But this wasn’t even mentioned in the headline conclusions.

Conclusions: The results of our analysis support a moderate positive association between processed meat consumption and mortality, in particular due to cardiovascular diseases, but also to cancer.

To find the result you have to dig into Table 3.

So, by both methods of calculation, the relative risk from eating red meat is negligible (except possibly in the top group, eating more than 160 g (7 oz) per day).

There is still an association between intake of processed meat and all-cause mortality, as in previous studies, though the association of processed meat with all-cause mortality, 1.09, or 1.18 depending on assumptions, is, if anything, smaller than was observed in the 2012 study, in which the relative risk was 1.20 (Table 2).

Assumptions, confounders and corrections.

The lowest meat eaters had only 13% of current smokers, but for the biggest red meat eaters it was 40%, for males. The alcohol consumption was 8.2 g/day for the lowest meat eaters but 23.4 g/day for the highest-meat group (the correlations were a bit smaller for women and also for processed meat eaters).

These two observations necessitate huge corrections to remove the (much bigger) effects of smoking and drinking if we want find the association for meat-eating alone. The main method for doing the correction is to fit the Cox proportional hazards model. This model assumes that there are straight-line relationships between the logarithm of the risk and the amount of each of the risk factors, e.g smoking, drinking, meat-eating and other risk factors. It may also include interactions that are designed to detect whether, for example, the effect of smoking on risk is or isn’t the same for people who drink different amounts.

Usually the straight-line assumption isn’t tested, and the results will depend on which risk factors (and which interactions between them) are included in the calculations. Different assumptions will give different answers. It simply isn’t known how accurate the corrections are when trying to eliminate the big effect of smoking in order to isolate the small effect of meat-eating. And that is before we get to other sorts of correction. For example, the relative risk from processed meat in Table 3, above, was 9% or 18% (1.09, or 1.18) depending on the outcome of a calculation that was intended to increase the accuracy of food intake records ("calibration").

The Conclusions of the new study don’t even mention the new result with red meat. All they mention is the risk from processed meat.

In this population, reduction of processed meat consumption to less than 20 g/day would prevent more than 3% of all deaths. As processed meat consumption is a modifiable risk factor, health promotion activities should include specific advice on lowering processed meat consumption.

Well, you would save that number of lives if, and only if, the processed meat was the cause of death. Too many epidemiologists, the authors pay lip service to the problem of causality in the introduction, but then go on to assume it in the conclusions. In fact the problem of causality isn’t even metnioned anywhere in either the 2012 study, or the new 2013 EPIC trial.

So is the risk of processed meat still real? Of course I can’t answer that. All that can be said is that it’s quite small, and as sample sizes get bigger, estimates of the risk are getting smaller. It wouldn’t be surprising if the risk from processed meat were eventually found not to exist, just as has happened for red (unprocessed) meat

The Japanese study

Last year there was another cohort study, with 51,683 Japanese. The results were even more (non-) dramatic [Nagao et al, 2012] than in the EPIC trial. This is how they summarise the results for the relative risks (with 95% confidence intervals).

"…for the highest versus lowest quintiles of meat consumption (77.6 versus 10.4 g/day) among men were 0.66 (0.45 — 0.97) for ischemic heart disease, 1.10 (0.84 — 1.43) for stroke and 1.00 (0.84 — 1.20) for total cardiovascular disease. The corresponding HRs (59.9 versus 7.5 g/day) among women were 1.22 (0.81 — 1.83), 0.91 (0.70 — 1.19) and 1.07 (0.90 — 1.28). The associations were similar when the consumptions of red meat, poultry, processed meat and liver were examined separately.

CONCLUSION: Moderate meat consumption, up to about 100 g/day, was not associated with increased mortality from ischemic heart disease, stroke or total cardiovascular disease among either gender."

In this study, the more meat (red or processed) you eat, the lower your risk of ischaemic heart disease (with the possible exception of overweight women). The risk of dying from any cardiovascular disease was unrelated to the amount of meat eaten (relative risk 1.0) whether processed meat or not.

Of course it’s possible that things which risky for Japanese people differ from those that are risky for Europeans. It’s also possible that even processed meat isn’t bad for you.

The carnitine study

The latest meat study to hit the headlines didn’t actually look at the effects of meat at all, though you wouldn’t guess that from the pictures of sausages in the headlines (not just in newspapers, but also in NHS Choices). The paper [reprint] was about carnitine, a substance that occurs particularly in beef, with lower amounts in pork and bacon, and in many other foods. The paper showed that bacteria in the gut can convert carnitine to a potentially toxic substance, trimethylamine oxide (TMAO). That harms blood vessels (at least in mice). But to show an effect in human subjects they were given an amount of carnitine equivalent to over 1 lb of steak, hardly normal, even in the USA.

The summary of the paper says it is an attempt to explain "the well-established link between high levels of red meat consumption and CVD [cardiovascular disease] risk". As we have just seen, it seems likely that this risk is far from being “well-established”. There is little or no such risk to explain.

It would be useful to have a diagnostic marker for heart disease, but this paper doesn’t show that carnitine or TMAO) is useful for that. It might also be noted that the authors have a maze of financial interests.

Competing financial interests Z.W. and B.S.L. are named as co-inventors on pending patents held by the Cleveland Clinic relating to cardiovascular diagnostics and have the right to receive royalty payments for inventions or discoveries related to cardiovascular diagnostics from Liposciences. W.H.W.T. received research grant support from Abbott Laboratories and served as a consultant for Medtronic and St. Jude Medical. S.L.H. and J.D.S. are named as co-inventors on pending and issued patents held by the Cleveland Clinic relating to cardiovascular diagnostics and therapeutics patents. S.L.H. has been paid as a consultant or speaker by the following companies: Cleveland Heart Lab., Esperion, Liposciences, Merck & Co. and Pfizer. He has received research funds from Abbott, Cleveland Heart Lab., Esperion and Liposciences and has the right to receive royalty payments for inventions or discoveries related to cardiovascular diagnostics from Abbott Laboratories, Cleveland Heart Lab., Frantz Biomarkers, Liposciences and Siemens.

The practical significance of this work was summed up the dietitian par excellence, Catherine Collins, on the BBC’s Inside Health programme.

Listen to Catherine Collins on carnitine.

She points out that the paper didn’t mean that we should change what we already think is a sensible diet.

At most, it suggests that it’s not a good idea to eat 1 lb steaks very day.

And the paper does suggest that it’s not sensible to take the carnitine supplements that are pushed by every gym. According to NIH

"twenty years of research finds no consistent evidence that carnitine supplements can improve exercise or physical performance in healthy subjects".

Carnitine supplements are a scam. And they could be dangerous.

### Follow-up

Another blog on this topic, one from Cancer Research UK also fails to discuss the problem of causality. Neither does it go into the nature (and fallibility) of the corrections for counfounders like smoking and alcohol,. Nevertheless that, and an earlier post on Food and cancer: why media reports are often misleading, are a good deal more realistic than most newspaper reports.

## The exploitation of cancer patients is wicked. Carrot juice for lunch, then die destitute

#### March 25th, 2013 · 10 Comments

The time when I lose patience with quacks is when they make unjustified claims about serious diseases. Giving false hope to the desperate (often at a high price) is plain wicked. If the patient stops more effective treatment, it’s homicide. Homeopaths have been jailed for that. Sometimes it’s a result of wishful thinking. Sometimes it’s to make money. The latter is morally more despicable. Both are culpable.

 One example was the Totnes (aka Narnia) to “offer real alternatives to the conventional approach to cancer health care“. Another case, the Dove Clinic, was investigated in the Sunday Times, by Jon Ungoed-Thomas and Justin Stoneman: Clinics mislead patients over cancer ‘cure‘.

There is yet another cancer conference, Back2Health, coming up in April (remember that "integrative", in this context, is a euphemism for quackery).

The speakers are listed on the left, as they were when I first noticed the conference in December 2012. On the right are the speakers as of February 2013,

Spot the difference

 18 December 2012 28 February 2013

Yes, the one respectable oncologist on the programme, Robert Thomas, has withdrawn from the meeting.

I came across Robert Thomas because it was pointed out to me that he spoke at a meeting of YesToLife, an organisation that advocates all sorts of treatments that are unsupported by evidence. That seemed like an odd thing for a respectable oncologist to be doing, so I wrote to him, to point out some of the bizarre beliefs of his fellow speakers. Most are familiar names in made-up medicine, but probably not widely known among real oncologists.

Professor Thomas seemed unaware of this because he told me

"Thank you for your email and pointing out the vitamin C issues which of course, as you say has no scientific basis and should be outlawed along with many other practices."

Nevertheless he thought it was too late to pull out of the YesToLife meeting, so went ahead.

After this Robert Thomas wrote to me again (18 December 2012) to ask for advice about another conference he’d been invited to speak at, the Back2health event. Again he seemed unaware of the reputations of his fellow speakers, just about all of whom have a track record of advocating treatments for which there is no good evidence. Many of them are purveyors of false hope, often at a high price. I’ll deal with only three of them.

Dr Rosy Daniel is there. She’s featured several times on this blog. I met her, with Karol Sikora,here. Her course in quackery was ditched by the University of Buckingham after a year..

Chris Woollams of CancerActive is also there. As readers of this blog will know, I accept he is an honest man and I do feel a great deal of sympathy for him having lost his daughter. This doesn’t mean I am any closer to accepting his views on cancer treatment.

Next to Thomas’s picture is Barbara Wren. She was secretly filmed by the BBC claiming "to have cured thyroid cancer by applying external compresses, half an hour with castor oil and half an hour with your own urine". You can’t get much barmier than that.

Then there is a nurse, Patricia Peat, who runs a private "integrative" cancer consultancy, Cancer Options. She’s a prominent supporter of YesToLife which, since at least February 8th 2013, has been promoting a video, "Cancer is Curable Now", which makes totally irresponsible claims (and is illegal in the UK under the Cancer Act, 1939). Among other baseless treatments she has advocated high dose Vitamin C.

“The first of these people is the proprietor of Cancer Options. Cancer Options is a private consultancy offering advice to cancer patients. It is run by Patricia Peat who is a qualified nurse. My dad went to see her and she told him the good news, if he followed her advice he could be tumour free in 3 to 4 years. She advised him to have intravenous vitamin C, to have oxygen therapy, heat therapy and to take a myriad of supplements.”

I have heard that the cost of these useless recommendations over a three months would have been £4,640, plus the considerable cost of moving to Brighton, to the Vision of Hope hospital. That includes, for example, a telephone consultation (£175), supplement pills (£400) and intravenous vitamin C (£3000). There is no good evidence that any of these would help the patient. Not only would this have destituted his family and taken the patient away from them: it would also have made his last days an unnecessary misery. For Christmas he would have been condemned to a vegan diet, no wheat, sugar or alcohol, and to live on five glasses of raw juice and two jars of sprouts a day (see "Would you kick a dying man" for a real life experience).

Patricia Peat appears prominently on another web site too, Self Help Cancer. There she’s partnered by Dr Chris Etheridge (an ex biochemist, turned herbalist, with no medical qualifications). On that site you’ll find every kind of barminess endorsed. It even takes seriously the notorious Burzynski clinic about which so much has been written, both here and in the USA.

Recommending a bit of foot massage or reiki as a way to relax distraught patients is harmless enough if you like that sort of thing. Recommending you to ignore real doctors is quite another. Patricia Peat is on record as saying (my emphasis).

"Also detoxification is as important as what goes in – the rapid removal of toxins from the body would be massively beneficial in reducing the side effects. If someone is on chemotherapy, its very important to get any herbal preparations checked out by a qualified practitioner, to make sure there are no interactions, with the chemotherapy. A lot of nutritional and herbal supplements are very strong, and it is dangerous to suppose that because they are natural, they can do no harm. Probably the worst person to ask about this is your oncologist "

There is, of course, no reason to think that "detoxification" is anything other than a figment of the imagination. There is no reason to think that (never-named) toxins are important, and no reason to think that the procedures get rid of anything.

If you want sound advice about diet, go to somewhere like the American Cancer Society. There you will find that most of the things that quack nutritionists love to sell you just don’t work. The ACS asks "Will a vitamin a day keep cancer away?". Their answer is

"Can popping vitamin pills prevent cancer? The simple answer is no, based on what we know so far. In fact, some vitamin supplements have even shown harm."

The journalist, John Diamond, described movingly the way that the alternative industry moved in on him when it became known that he had cancer. His book, Snake Oil and Other Preoccupations was never finished before he died. These extracts from the foreword to the book, by Richard Dawkins, sum it up.

"When the pathologist has read the runes; when the oracles of X-ray, CT scan and biopsy have spoken and hope is guttering low; when the surgeon enters the room accompanied by ‘a tallish man … looking embarrassed … in hood and gown with a scythe over his shoulder’, it is then that the ‘alternative’ or ‘complementary’ vultures start circling. This is their moment. This is where they come into their own, for there’s money in hope: the more desperate the hope, the richer the pickings. And. to be fair, many pushers of dishonest remedies are motivated by an honest desire to help. Their persistent importunings of the gravely ill, their intrusively urgent offers of pills and potions, have a sincerity that rises above the financial greed of the quacks they promote. "

"They are targets that deserve to be hit hard, targets whose neutralisation would leave the world a better place: cynical charlatans (or honest foolish dreamers) who prey on gullible unfortunates. And the best part is that although this gallant man is dead, his guns are not silenced"

Shortly before he died, John Diamond said something that I think is one of the most perceptive comments that I’ve ever read. Some of the blame for the rise of the profitable alternative industry lies with the hype of real medicine. It’s worth quoting at length.

 "But we expected more. Hell, we’d been promised more. Just as we’d learned, rightly, to expect that the political system could be arranged to provide a roof over the head and food in the stomach of all of us, so, we believed, could the medical system be arranged to give us all health and happiness. It was our right, dammit. And the medical establishment, flattered by all those pieces in the popular press describing the latest miracle cure which was just about —always just about — to arrive at the local surgery, joined in with the celebrations and connived with the scam. Indeed, if the boom in alternative medicine is anybody’s fault it’s that of orthodox medicine. It was the orthodoxy -helped by the media and our own vanity – which allowed us to believe that we could all be healthy and happy, that there was a pill for every problem and that if we died too early or too painfully it was an act of some agency other than capricious old God. The orthodoxy allowed us to expect miracles and then, when it couldn’t provide them, got annoyed when we started looking elsewhere. And the elsewhere we looked to was the alternative practitioners. They were only too willing to take our custom . . ." John Diamond, Snake Oil and other preccupations,(2001, Vintage) pp 20 – 21

I have no way of knowing whether the people at this conference are "cynical charlatans" or "honest foolish dreamers". I impute no motives. But I can say that their treatments are very expensive and for the most part they don’t work.

There is an interesting question about the extent to which charities like YesToLife function as charities, and the extent to which they act as agencies that channel desperate patients into the hands of private hucksters. I don’t pretend to know tha answer. I’d like to.

 “It is difficult to get a man to understand something, when his salary depends upon his not understanding it.” Upton Sinclair

### Follow-up

1 April 2013. The Times contacted me shortly after this came out, about some of the (illegal) nonsense to be found on sale at Amazon. One of their journalists, Kat Lay, did a good write-up, and they contacted the MHRA and stirred it into action. [download pdf].

5 April 2013. I quoted some of Patricia Peat’s views on diet from a page on Woollams’ blog. I notice that the copyright conditions on that page changed

" This content may be copied, in full or in part", has been changed to " No content may be reproduced, in whole or in part".

It’s curious that there should be an attempt to ban the reproduction of content, of which he authors are presumably proud, and which appears on a public web site. Of course it is also baseless in law, because copyright law has always allowed reproduction of parts of any document for the purposes of fair comment or in the public interest.

20 May 2012

In the USA, the first amendment allows the most outrageous claims to be made. But when they do decide the law has been broken, they do something about it. Their law enforcement is not as pathetically impotent as in the UK.

A Dr Christine Donald treated patients with cancer with an expensive herbal concoction, from her Wellness Clinic in San Fernando Valley. She promised 60 – 80% success rate. she was trusted because she was also a Pentecostal minister.

She was convicted of four counts of mail and wire fraud, six counts of tax evasion and one count of witness tampering she was found guilty of in September 2011

She was sentenced to 14 years in jail and a fine of $1.2 million. One wonders why that never happens in the UK 26 May 2013 I noticed another incredible assertion by Patricia Peat. “One could be forgiven for thinking how does anyone manage to die from cancer when the answers to curing it are actually so simplistic and one dimensional.” So that’s solved, then. 10 June 2013. I have just come across a good source of information about all sorts of alternative cancer treatments. "CAM-Cancer" was originally funded by the European Commission (EC) within the Framework 5 Programme, it is now hosted by the National Information Center for Complementary and Alternative Medicine (NIFAB) at the University of Tromsø, Norway. ## The British Pharmacological Society and the MHRA don’t help the cause of honest science. They hinder it. #### February 27th, 2013 · 9 Comments Jump to follow-up The bulletin of the British Pharmacological Society, Pharmacology Matters, declined to publish the following article. Sadly the Society seems to be more interested in "reputation management" than in truth. Luckily, it is not easy to suppress criticism these days. A version of the article has appeared in Research Fortnight where it will be seen by far more people than it would have been in Pharmacology Matters. This is the original version that I submitted to them. They would not allow me to quote Lewis’s comment (apropos of the sale of homeopathic meningitis vaccine) “Children will be harmed by this inaction. Children will die. And the fault must lie with Professor Sir Kent Woods, chairman of the regulator [MHRA].” If a child were to die of whooping cough or meningitis as a result of buying the fraudulent "vaccines", that would be true. It’s a sad reflection on the state of defamation law that journals are not willing to say so. Blogs are fast becoming the best source of reliable information. Stop press. The BPS has now signed up to Alltrials (too late for the printed version) ### Pharmacology society does little to defend its subject David Colquhoun Over the past few years a courageous group of writers, researchers and activists has worked to expose the truth about the medicines we are sold, be they conventional or alternative. Thanks, above all, to Ben Goldacre (1), more people than ever know that the big pharma companies have been concealing evidence of the harm that their products do, or the good they fail to do. Thanks to a small army of bloggers the preposterous claims made by peddlers of homeopathic remedies and other quackery are less likely to go unchallenged. And yet, the organization charged with safeguarding the good name of pharmacology in this country, the British Pharmacological Society (BPS), has remained silent throughout. The pharmaceutical industry The BPS, rather than helping, became actively complicit when, along with much of the medical establishment, it signed an agreement with the ABPI (2). This document, developed under the aegis of the Ethical Standards in Health & Life Sciences Group (ESHLSG), contained two objectionable clauses: “Industry plays a valid and important role in the provision of medical education” And “Medical representatives can be a useful resource for healthcare professionals” Given that clinical “education” has long been part of Pharma’s marketing strategy, this seems disgraceful. And most of the doctors I know and respect refuse to see reps altogether. It is hopelessly optimistic to think that can an industry person can teach clinical pharmacology without bias in favour of his own company’s products. The BPS has many members who teach pharmacology. Can they really cope so badly that we need to have industry to educate clinicians? It’s fine, and sometimes desirable, for academics and industry to work together on drug development. But only as long as the industry partner has no say in how, or whether, the results are published. Without that proviso we can expect more corruption of the sort that’s been seen at the University of Sheffield (3). This is very sad, because I have great reason to like the drug industry. I’ve benefitted from several of their products myself. But the industry is in trouble. Many of its products provide only marginal benefits. Furthermore, some of the things that seemed to be useful, like SSRI antidepressants, have turned out to be next to useless once hidden trials were revealed (4). The MHRA’s learning module on SSRIs doesn’t seem to have caught up with this yet. Sadly, the reaction of industry has been to resort to dishonesty, to hide unfavourable data and to increase yet more what it spends on marketing. Between 2009 and 2012, fines of at least 10 billion dollars (5) have been imposed on some of the most eminent companies. They include Lilly, Pfizer, AstraZeneca, Merck, Abbott and GlaxoSmithKline (GSK). The biggest fine of all ($3 bn, in July 2012) went to a British company, GSK.  This succession of large fines seems to be regarded by the companies as mere marketing expenses.

All these fines were levied in the USA.  Where, one might ask, are the regulators in the UK?  Why have there been no fines here? Why, indeed, are some of the senior managers of these companies not in jail?  Why has the BPS remained silent about the prostitution of its subject?  And why have the MHRA done so little to stop it?

I suggest that you support the petition for release of the results of all trials (6). It’s been supported by many individuals and a lot of organisations, including the BMJ and the Royal Statistical Society.  But, disgracefully, not by the BPS.

Quackery

At least in the case of the pharmaceutical industry some of its products work.  But pharmacologists should also be concerned about the quackery industry, worth about 60 billion dollars per year (as opposed to \$600 bn for the pharmaceutical industry).  Virtually none of their products work (7). Why has the BPS said so little about it?  It has, along with most of the medical and university establishment, shrugged its shoulders about the fact that students at Westminster University have been shown dowsing with a pendulum as a method for selection of herbal “remedies”, as part of a Bachelor or “Science” degree.  It is an area in which every regulatory agency has failed to ensure even minimal levels of honesty (8).  And the BPS has just shrugged.

The MHRA has been worse than useless in this area: it has been actively unhelpful (9).  The senior staff of the MHRA are members of the BPS which has, as usual, said next to nothing.  The MHRA’s herbal medicine committee has allowed misleading labels that give indications to be put on herbal potions, and these labels fail to make it clear that no evidence whatsoever of efficacy is required to get the MHRA kitemark.  The wording was suggested (not required) by European law, but that law does not prevent the MHRA from saying, as it should, “there is no reason to think that this product is effective for any of the indications on the label” (10).  Arguably, the MHRA is in breach of Consumer Protection law (11, 12).

At the time, the BPS did make some objection to the labelling (13), but only under great pressure from me (indeed I wrote it) .  That has not been followed up, and I can no longer find it on the BPS web site.  Indeed Philip Routledge, one of the people who is responsible for the misinformation in his capacity as chair of the MHRA Herbal Medicines Advisory Committee, is, at present the president of the BPS.

The MHRA has also been responsible for misleading labelling of the products of the most obviously fraudulent products of the lot: homeopathic pills, the medicines that contain no medicine.  Most of the pills (anything beyond 12x dilution) contain not a single molecule of the substance on the label.  Yet they have been given a get-out clause that enables them to evade prosecution by Trading Standards (an organisation that consistently fails to apply consumer protection laws.  Rose et al (2011) (12) concluded

"EU directive 200s5/29/EC is largely ineffective in preventing misleading health claims for consumer products in the UK".

It is simply bizarre that the people at the MHRA, many of who are BPS members, have sat round a table and approved the following label. This example is for Arnica 30C pills, which, of course, contain no trace of arnica (14, 8). The outcome of their deliberations is simply surreal (see the actual labels here).

"Used within the homeopathic tradition for the symptomatic relief of sprains, muscular ache; and bruising or swelling after contusions."

This will deceive the naïve into thinking that it will have some effect on sprains etc. It won’t. And the MHRA have declined to test how the label is perceived by the public, though it took some effort to get them to admit it.

"If you are allergic to any of the ingredients in this medicine, consult your doctor before taking this medicine."

The ingredients aren’t stated apart from “contains lactose and sucrose”. That’s all they contain. No arnica.

"If pregnant or breastfeeding consult your doctor before use."

Why should a few mg of lactose and sucrose have the slightest effect on a pregnant or breast-feeding mother. This is pure make-believe

"If you forget to take this product, continue to take your usual dose at the usual time, it does not matter if you have missed a dose. Do not take a double dose to make up for a missed dose."

This statement is even more bizarre. There is nothing in the pills.

"If you take too much of this product (overdose) speak to a doctor or pharmacist and take this label with you."

And this is the ultimate in nonsense. The 1023 campaign regularly swallows whole bottles, and of course nothing happens. You can’t overdose on nothing. The fact that the MHRA can insist on this label, with a straight face, is the ultimate betrayal of science and reason.

"When asked to comment, as part of the consultation on these rules, this was the response from the BPS."

This is extracted from page 16 of the “selected response” provided by the MHRA under a Freedom of Information Act request [download all]

Things have changed little since A.J. Clark wrote his book on Patent Medicines in 1938 (15).  And the BPS has done next to nothing to help. Neither has the MHRA. In fact both have colluded in the failures of both honesty and reason.

A BBC South West program recently revealed that a pharmacist was selling “homeopathic vaccines” for whooping cough and meningitis (16).  The MHRA have know about his homicidal practice for years, but have done nothing.  The General Pharmaceutical Council let him off with a rap on the knuckles.  It has been left to bloggers and TV reporters to focus attention on these scoundrels. The well-respected blogger, Andy Lewis, wrote (17)

“Children will be harmed by this inaction. Children will die. And the fault must lie with Professor Sir Kent Woods, chairman of the regulator [MHRA].”

And the full clinical data for Tamiflu are still being concealed by Roche (18).

I think that is rather shameful.

I have been a member of the BPS for all my working life. I was happy when they made me an honorary fellow. But I now find myself asking if I can remain a member of an organisation that has done so little to defend honest scientific behaviour.

References

(1) Ben Goldacre’s Bad Pharma. Buy it now. Then do something. http://www.dcscience.net/?p=5538

(2)  ABPI 2012 Guidance on collaboration between healthcare professionals and the pharmaceutical industry.   http://www.abpi.org.uk/our-work/library/guidelines/Pages/collaboration-guidance.aspx

(3) Colquhoun, D. (2007)  The Corporate Corruption of Higher Education: part 2 http://www.dcscience.net/?p=193

(4) Kirsch,I., B.J.Deacon, T.B.Huedo-Medina, A.Scoboria, T.J.Moore, and B.T.Johnson. 2008. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS. Med. 5:e45.  http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050045

(5) Groeger, L. (2012) Big Pharma’s Big Fines http://www.propublica.org/special/big-pharmas-big-fines

(6) All trials registered. All results reported, http://www.alltrials.net/supporters/

(7) Singh,S. and E.Ernst. 2009. Trick or Treatment. Corgi. http://en.wikipedia.org/wiki/Trick_or_Treatment

(8) Colquhoun, D. (2012) Regulation of alternative medicine: why it doesn’t work, and never can. http://www.dcscience.net/?p=5562

(9)  Colquhoun, D, (2006) The MHRA breaks its founding principle: it is an intellectual disgrace.  http://www.dcscience.net/?p=32

(10)  Colquhoun, D. (2011). Why does the MHRA refuse to label herbal products honestly? Kent Woods and Richard Woodfield tell me. http://www.dcscience.net/?p=4269

(11) Colquhoun, D. (2009) Most alternative medicine is illegal. http://www.dcscience.net/?p=30

(12) Rose,L.B., P.Posadzki, and E.Ernst. 2012. Spurious claims for health-care products: an experimental approach to evaluating current UK legislation and its implementation. Med. Leg. J. 80:13-18. http://www.dcscience.net/Rose-medico-legal-2012.pdf

(13) Colquhoun, D. (2006) Learned Societies speak out against CAM, and the MHRA. http://www.dcscience.net/?p=30

(14) MHRA Arnicare Arnica 30c pillules NR 01175/0181 http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con049307.pdf

(15)  Colquhoun, D. (2008) Patent medicines in 1938 and now: A.J.Clark’s book. http://www.dcscience.net/?p=257

(16) BBC South West on the evils of homeopathic "vaccines"  http://www.youtube.com/watch?v=TZf9mUzI4RI

(17) Why Does the MHRA Not Close Down these Homeopaths? The regulators have known of serious problems for years, Nothing is done. http://www.quackometer.net/blog/2013/01/why-does-the-mhra-not-close-down-these-homeopaths.html

(18)  Payne, D. (2012). Tamiflu: the battle for secret drug data http://www.bmj.com/content/345/bmj.e7303

### Follow-up

25 February 2013 This post has some follow-up even before it appeared on Research Research. I noticed on the BPS web site a press release “BPS announces intention to sign All Trials Petition“. It was dated 20th February, but I didn’t notice it until after the printed edition went to press. It was expressed as a future intention to sign, though in fact they signed almost straight away (though over 100 organisations had already done so). That’s good. I suspect that when my old friend, Humphrey Rang, who is president elect of the BPS, takes charge, the Society may start to take its responsibilities to the public more seriously than it has in the past.

 The MHRA, on the other hand, is still evading its self-declared job of ensuring the public that drugs work.

13 March 2013. A reply to this piece appeared in red on Research Research, The British Pharmacological Society champions its science. It was written by Humphrey Rang who, as president elect of the BPS naturally felt obliged to defend its record. He defends the BPS membership of ESHLSG, but fails to mention that first the Lancet and then the BMA withdrew their support. Nor does he mention that medical students and doctors launched a campaign, BadGuidelines.org, against the agreement. The Medical Schools Council, which also signed the agreement, said "the scrutiny of the guidance has ‘identified deficiencies in the current statement". Didn’t they read it before signing? Rang says that the BPS is also working to improve the joint statement with the ABPI. That’s good, but one must wonder why the BPS signed up to the original form.

On the points about quackery, Rang sites the BPS statement on homeopathy (now vanished) but fails to mention that that statement was written by me in an attempt to wake the BPS from it’s slumbers on the matter of medicines that don’t work. But he doesn’t mention at all the matter of mislabelling of both homeopathic and herbal preparations.

Of course, the BPS does many good things. But like most organisations, it is too reluctant to speak out when it sees wrongdoing, and too reluctant to say "sorry we made a cock-up that time".

## Policy-based evidence. Department of Health and Prince’s Foundation censor accurate information about magic medicines

#### February 13th, 2013 · 34 Comments

 “In causing NHS Choices to publish content that is less than completely frank about the evidence on homeopathy, the DH have compromised the editorial standards of a website that they themselves established”. . . “. . . they have failed the general public, by putting special interests, politics, and the path of least resistance (as they saw it) before the truth about health and healthcare.” David Mattin, lately of NHS Choices

NHS Choices is usually a good source of information for the public. But there is one exception: the information they provide about alternative medicine is poor. A Freedom of Information Act request has revealed that the attempt of NHS Choices to rewrite their pages more accurately was censored by the Department of Health in conjunction with the late Prince’s Foundation for Integrated Health. The Department of Health (DH) has misled the public.

The earliest version of the homeopathy information page recorded by the Wayback Machine was November 12 2007. It was still there on December 5 2010. The comments were mostly critical. One said, quite correctly,

 I find it most regrettable that the way NHS has covered this subject is to give uncritical voice to the claims of homoeopathy without giving readers the information they need to evaluate those claims. To refer readers to the websites of the British Homeopathy Association is like settling the question of the shape of planet by a reference to the website of the Flat Earth Society

There were a lot of complaints, and to the credit of NHS Choices, the page vanished. Throughout 2011, and up to October 2012 the information page on homeopathy read

 Introduction Content on homeopathy has been removed from the website pending a review by the Department of Health policy team responsible for complementary and alternative medicines. Homeopathy is not part of mainstream medicine. Instead it is defined as a complementary or alternative medicine. If you are considering using homeopathy, talk to your GP first. For more information about homeopathy see the House of Commons Science and Technology Committee report on homeopathy published on 8 February 2010 and the Department of Health response to that report published in July 2010 (PDF, 69KB).

Then, at the end of 2012, the page reappeared. It was a bit better than the original, but not much. Many of the comments criticise the misleading nature of the information (as well as the usual “it worked for me” comments). The “useful links” still has six links to flat-earth organisations like the Society of Homeopaths, and only one to a sensible source, the excellent pamphlet from Sense about Science. They do link at the end to the 2010 Science and Technology Committee Report: Evidence Check 2: Homeopathy (PDF, 1.61Mb), and to the Government Response to the Science and Technology Committee Report, Evidence Check 2: Homeopathy (PDF, 69kb) but no comment is made on the findings.

Policy-based evidence

I wondered why the NHS Choices page, after an absence of almost two years, had returned in such an unsatisfactory form. So I asked them. After a reminder, I was told that my queries were being dealt with not by NHS Choices, but had been referred to Dr Sunjai Gupta “the DH official with responsibility for this area”. Dr Sunjai Gupta OBE is Deputy Director of Public Health Strategy and Social Marketing, Department of Health.

Dr Gupta is not obviously sympathetic to woo. It’s hard to tell since he doesn’t seem to have published much. But one is not reassured by an article that he wrote for the Journal of Holistic Healthcare. It appears straight after an article by fantasy herbalist, Simon Mills.

Despite assurances that I’d hear from Dr Gupta shortly, nothing happened. So I sent a request for the correspondence under the Freedom of Information Act (2000). Although the request was addressed to NHS Choices, a public body, strenuous efforts were made to divert it to the Department of Health. These were resisted. Nevertheless when, after a long delay, the material arrived, it came not from NHS Choices, but from DH, who had evidently vetted it,. The emails were rather shocking [download all].

A mail dated 1 December 2009 said

This is the most direct statement I’ve seen that, in the Department of Health, policy dictates evidence. NHS Choices is meant to provide evidence, but what they say has to be checked by DH to make sure they “don’t clash with any policy messages”.

The re-written page

The original version of the re-written page was sent to me by David Mattin, who worked for NHS Choices until September 2012. You can download the whole draft here. It is an enormous improvement on the original page. For example, it says

 “Does it work? Many independent experts would respond to this question ‘no, homeopathy does not work’ There is no good quality clinical evidence to show that homeopathy is more successful than placebo in the treatment of any type of condition. A placebo is the unusual but well-documented psychological effect that sometimes occurs when a person is given a ‘dummy’ medication, such as a sugar pill. They feel better after taking the pill because they think that they are being given real medication. Furthermore, if the principles of homeopath were true it would violate all the existing theories of science that we make use of today; not just our theory of medicine, but also chemistry, biology and physics.

This original draft was sent to Mattin on 29 January 2010. After editing it for length Mattin sent it to DH for approval. Over the next two years, DH removed much of the accurate content.  Mattin’s own comments on this evisceration are reproduced below.

The DH emails

All the names have been redacted. Needless to say, nobody is willing to take responsibility. But the number of people who support magic medicine is really quite small so the main players were easy to identify.

During the nearly 2 year absence of the homeopathy page, dozens of changes were made by DH. It seems that the policy message with which the NHS Choices draft failed to comply were those of the Prince’s Foundation for Integrated Health, and its successor (after April 2010), the College of Integrated Health, now known as the College of Medicine.

NHS Choices sought advice about their redrafted pages from the right person, Sir Iain Chalmers, one of the founders of the Cochrane Collaboration. On 3 Nov 2009, Chalmers advised

  The most reliable source in the country - and one of the most reliable in the world - is Professor Edzard Ernst, professor of Complementary Medicine at the Peninsular Medical School,

Ernst returned his suggestions in July 2010, but it seems that few of them survived the subsequent 18 months of revisions by DH.

On 2 December 2009, a mail from the NHS headquarters (Quarry House, Leeds) was sent to NHS Choices

This makes it perfectly clear that DH regards the Prince’s Foundation, and the equally flaky Complementary and Natural Healthcare Council (CNHC: known on the web as Ofquack) as appropriate guides for public health policy. The fact of the matter is that regulation of magic medicine by the government has been a total disaster, because, it seems, DH regards the Prince of Wales as a reliable source.

On 29 December 2009, the Prince’s Foundation went on the attack.

On 10th January 2010, two more letters were sent to DH by the Prince’s Foundation. At 13.48 they wrote

And at 22.14 on the same day, it was followed up with

The references to Devon and to Thought Field Therapy, make it very obvious that these letters were written by Dr Michael Dixon OBE, who was medical director of the Prince’s Foundation, and who is now a director of the “College of Medicine”. And the object of Dixon’s bile is obviously Edzard Ernst (the quotation is from his book, Trick or Treatment).

I find it fascinating to see just how venomous quacks become when the evidence contradicts their views. The cuddly “holistic” veneer quickly vanishes.

It gets worse. On 21 January 2010, a mail from NHS Choices to DH said

The only person in the country who fits this description is the (in)famous George Lewith. It is simply mind-boggling that DH regards him as an appropriate person to advise on anything.

After that, NHS Choices kept asking DH to sign off the documents, and changes continued to be made. Almost two years later, DH were still stalling.

The admission that “We are a bit short of doctors within DH these days” is interesting.

A bit short of anyone capable of critical thinking would be more accurate.

The most interesting document that I got from DH was an intermediate draft of the rewritten page on homeopathy (undated). Download the document. Here are a couple of extracts.

It’s a story of two years of meddling and procrastination. The end result misinforms the public.

Right at the start, the NHS Choices draft says, reasonably enough

A House of Commons Science and Technology Committee report said that homeopathic remedies perform no better than placebos and that the principles on which homeopathv is based are “scientifically implausible”.

But a comment, added apparently by DH, says

Can we remove this statement? This report is really quite contentious and we may well be subject to quite a lot of challenge from the Homeopathic community if published.

What on earth? The DH seems to think that that its job is not to present the evidence, but to avoid challenges from the homeopathic community! And true enough, this piece is missing from the final version.

A bit later, the NHS Choices draft was censored again

“A 2010 Science and Technology Committee report said that scientific tests had shown that homeopathic treatments don’t work”

But again this doesn’t appear in the final version. The comment, apparently from DH, says

“The DH response to this report (point 24) doesn’t support this statement though”

That’s a gross distortion of point 24, which actually concludes

“The Government Chief Scientific Adviser cannot envisage scientifically credible proposals for funding for research into homeopathy in the future”

NHS Choices was not happy with the result

Shortly before the revised page was published, Paul Nuki, Editor in Chief of NHS Choicea, sent an email to DH.

 Date: 7th September 2011 Time: 3:33:42 pm Hi I’ve been through the CAM articles and asked that we publish them asap as requested. XYZ has asked that we get a couple of points checked …. For the record, we will be publishing these pieces outside of the normal editorial process. Although originally signed off by a suitably qualified clinician, the time lapse and policy changes have been so substantial as to render that null and void. We also don’t have a formal written policy sign off from XYZ and you should be aware that the process followed is unlikely to satisfy the of the Information Standard were the file to be audited.

It doesn’t need much reading between the lines to see that he was unhappy with the result. It will be interesting to see whether the Information Standard people at the Royal Society for Public Health do anything about it.

The Department of Health has not just ignored evidence but actively opposed it.

That’s the only possible conclusion from the documents that I was sent. And it’s pretty shocking that the DH has preferred advice from the Prince’s Foundation and its handful of acolytes (in particular Michael Dixon and George Lewith) to the findings of the Science and Technology Select Committee and the views of the Chief Scientific Advisor.

In January this year, the Chief medical Officer, Dame Sally Davies, said, in a rare outburst of candour

 ‘I’m very concerned when homeopathic practitioners try to peddle this way of life to prevent malaria or other infectious disease,” she said. “I am perpetually surprised that homeopathy is available on the NHS.” Dame Sally, who is England’s most senior doctor, concluded by remarking that homeopathy “is rubbish”.

So one part of DH is working to contradict another part. the Chief Medical Officer. Perhaps Sally Davies should have a word with Dr Gupta.

This all predates the advent of Jeremy Hunt (and known defender of homeopathy) as health minister. But the sympathies of some DH people are made obvious by the presence on the DH web site of an article “Personal health budgets: A new way of accessing complementary therapies?”. This astonishing piece confirms the worst fears that quacks will see personal health budgets as a commercial opportunity to peddle their wares. The article is by Jim Rogers of Lincoln University. What his paper does not mention is Rogers’ conflict of interest. He’s a homeopath, and he has a paper in the International Journal of High Dilution Research (yes, there is a journal for every form of make-believe). You can download a reprint of this paper. It advocates more research into homeopathic provings, something that even George Lewith seems to have given up on.

It’s about time that the DH started to listen to the Chief Medical Officer. As it is, some people at DH seem to prefer the advice of the Prince’s Foundation, and to actively suppress employees who prefer evidence to anecdote.

One thing is clear. The DH is an unholy mess. Parts of it are intent on producing policy-based evidence.

Comment by David Mattin, who edited the first draft for NHS Choices

David Mattin left NHS Choices in September, 2012. He edited the new version and lived through the two years of wrangling with DH during which much of the best content was eviscerated. He sent me this statement about the affair.

### Follow-up

13 February 2013 The Guardian version of this story, written by Sarah Boseley, is Prince’s charity lobbied government to water down homeopathy criticism. It’s fine as far as it goes but it doesn’t name any names. There are some good comments though.

14 February 2013. The printed Guardian gave the story full 5 column-width coverage. [download print version]

And news has reached the USA: there’s an account of the affair on the Neurologica blog: Politics trumping science at the NHS.

On 14 February, the Guardian version was Editor’s Choice by lunchtime, and the Guardian web version already had 414 comments, mostly sensible (though this blog got far more referrals from twitter than from the Guardian)

And news has reached the USA: there’s an account of the affair on the Neurologica blog: Politics trumping science at the NHS.

15 February 2013. The Daily Mail had very fair coverage of the story.

The Guardian closed the comments on the story when it had got 642 comments, most of them very sensible. And this page got almost 6000 hits in 24 hours. The majority of the referrals came from Twitter rather than from the Guardian, despite the direct link to the page from the Guardian.

18 February 2013. The affair featured in BMJ News [download the reprint]. The item featured prominently on the BMJ news page.

19 February 2013 Only six days of this post, the NHS Choices page has been re-written again, in a much improved form. That looks like bloggers 1, DH 0. It is baffling that it’s left to bloggers, working for nothing, to extract a bit of sense from the highly-paid civil servants at the Department of Health. But at least they listened this time, which is a lot more than happens often. Paul Nuki, who runs NHS Choices, deserves congratulations. Of course the revised page still doesn’t call a spade a spade, but it gets close at times. I like the way it starts "Homeopathy is a ‘treatment’ based". Notice the quotation marks.

Reputation management?

Incidentally, NHS Choices is outsourced to the (in)famous company, Capita. And the moderation of the comments on their site is outsourced again to Tempero, which describes itself as a "reputation management" company. Each of them creams off money meant of patient care. This discovery might explain why I and others have had comments rejected by NHS Choices several times. "Reputation management" is the antithesis of evidence. It is public relations, i.e. paid lying. That is quite wrong for a site that is meant to provide dispassionate information.

21 February 2013. Sadly a step backwards. Part of the improved page was removed. This bit.

The Chief Medical Officer, Professor Dame Sally Davies, has said there is no scientifically plausible way that homeopathy can prevent or cure diseases. She has made it clear she is particularly concerned about the use of homeopathy in developing countries as a so-called cure for malaria.

We can only speculate why this was removed, because it was true. In fact she accurately described homeopathy as "rubbish". Why she should not be quoted beats me.