Truth, falsehood and evidence: investigations of dubious and dishonest science

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 “Statistical regression to the mean predicts that patients selected for abnormalcy will, on the average, tend to improve. We argue that most improvements attributed to the placebo effect are actually instances of statistical regression.” “Thus, we urge caution in interpreting patient improvements as causal effects of our actions and should avoid the conceit of assuming that our personal presence has strong healing powers.”

In 1955, Henry Beecher published "The Powerful Placebo". I was in my second undergraduate year when it appeared. And for many decades after that I took it literally, They looked at 15 studies and found that an average 35% of them got "satisfactory relief" when given a placebo. This number got embedded in pharmacological folk-lore. He also mentioned that the relief provided by placebo was greatest in patients who were most ill.

Consider the common experiment in which a new treatment is compared with a placebo, in a double-blind randomised controlled trial (RCT). It’s common to call the responses measured in the placebo group the placebo response. But that is very misleading, and here’s why.

The responses seen in the group of patients that are treated with placebo arise from two quite different processes. One is the genuine psychosomatic placebo effect. This effect gives genuine (though small) benefit to the patient. The other contribution comes from the get-better-anyway effect. This is a statistical artefact and it provides no benefit whatsoever to patients. There is now increasing evidence that the latter effect is much bigger than the former.

How can you distinguish between real placebo effects and get-better-anyway effect?

The only way to measure the size of genuine placebo effects is to compare in an RCT the effect of a dummy treatment with the effect of no treatment at all. Most trials don’t have a no-treatment arm, but enough do that estimates can be made. For example, a Cochrane review by Hróbjartsson & Gøtzsche (2010) looked at a wide variety of clinical conditions. Their conclusion was:

“We did not find that placebo interventions have important clinical effects in general. However, in certain settings placebo interventions can influence patient-reported outcomes, especially pain and nausea, though it is difficult to distinguish patient-reported effects of placebo from biased reporting.”

In some cases, the placebo effect is barely there at all. In a non-blind comparison of acupuncture and no acupuncture, the responses were essentially indistinguishable (despite what the authors and the journal said). See "Acupuncturists show that acupuncture doesn’t work, but conclude the opposite"

So the placebo effect, though a real phenomenon, seems to be quite small. In most cases it is so small that it would be barely perceptible to most patients. Most of the reason why so many people think that medicines work when they don’t isn’t a result of the placebo response, but it’s the result of a statistical artefact.

Regression to the mean is a potent source of deception

The get-better-anyway effect has a technical name, regression to the mean. It has been understood since Francis Galton described it in 1886 (see Senn, 2011 for the history). It is a statistical phenomenon, and it can be treated mathematically (see references, below). But when you think about it, it’s simply common sense.

You tend to go for treatment when your condition is bad, and when you are at your worst, then a bit later you’re likely to be better, The great biologist, Peter Medawar comments thus.

 "If a person is (a) poorly, (b) receives treatment intended to make him better, and (c) gets better, then no power of reasoning known to medical science can convince him that it may not have been the treatment that restored his health" (Medawar, P.B. (1969:19). The Art of the Soluble: Creativity and originality in science. Penguin Books: Harmondsworth).

This is illustrated beautifully by measurements made by McGorry et al., (2001). Patients with low back pain recorded their pain (on a 10 point scale) every day for 5 months (they were allowed to take analgesics ad lib).

The results for four patients are shown in their Figure 2. On average they stay fairly constant over five months, but they fluctuate enormously, with different patterns for each patient. Painful episodes that last for 2 to 9 days are interspersed with periods of lower pain or none at all. It is very obvious that if these patients had gone for treatment at the peak of their pain, then a while later they would feel better, even if they were not actually treated. And if they had been treated, the treatment would have been declared a success, despite the fact that the patient derived no benefit whatsoever from it. This entirely artefactual benefit would be the biggest for the patients that fluctuate the most (e.g this in panels a and d of the Figure).

Figure 2 from McGorry et al, 2000. Examples of daily pain scores over a 6-month period for four participants. Note: Dashes of different lengths at the top of a figure designate an episode and its duration.

The effect is illustrated well by an analysis of 118 trials of treatments for non-specific low back pain (NSLBP), by Artus et al., (2010). The time course of pain (rated on a 100 point visual analogue pain scale) is shown in their Figure 2. There is a modest improvement in pain over a few weeks, but this happens regardless of what treatment is given, including no treatment whatsoever.

FIG. 2 Overall responses (VAS for pain) up to 52-week follow-up in each treatment arm of included trials. Each line represents a response line within each trial arm. Red: index treatment arm; Blue: active treatment arm; Green: usual care/waiting list/placebo arms. ____: pharmacological treatment; – – – -: non-pharmacological treatment; . . .. . .: mixed/other.

The authors comment

"symptoms seem to improve in a similar pattern in clinical trials following a wide variety of active as well as inactive treatments.", and "The common pattern of responses could, for a large part, be explained by the natural history of NSLBP".

In other words, none of the treatments work.

This paper was brought to my attention through the blog run by the excellent physiotherapist, Neil O’Connell. He comments

"If this finding is supported by future studies it might suggest that we can’t even claim victory through the non-specific effects of our interventions such as care, attention and placebo. People enrolled in trials for back pain may improve whatever you do. This is probably explained by the fact that patients enrol in a trial when their pain is at its worst which raises the murky spectre of regression to the mean and the beautiful phenomenon of natural recovery."

O’Connell has discussed the matter in recent paper, O’Connell (2015), from the point of view of manipulative therapies. That’s an area where there has been resistance to doing proper RCTs, with many people saying that it’s better to look at “real world” outcomes. This usually means that you look at how a patient changes after treatment. The hazards of this procedure are obvious from Artus et al.,Fig 2, above. It maximises the risk of being deceived by regression to the mean. As O’Connell commented

"Within-patient change in outcome might tell us how much an individual’s condition improved, but it does not tell us how much of this improvement was due to treatment."

In order to eliminate this effect it’s essential to do a proper RCT with control and treatment groups tested in parallel. When that’s done the control group shows the same regression to the mean as the treatment group. and any additional response in the latter can confidently attributed to the treatment. Anything short of that is whistling in the wind.

Needless to say, the suboptimal methods are most popular in areas where real effectiveness is small or non-existent. This, sad to say, includes low back pain. It also includes just about every treatment that comes under the heading of alternative medicine. Although these problems have been understood for over a century, it remains true that

 "It is difficult to get a man to understand something, when his salary depends upon his not understanding it." Upton Sinclair (1935)

Responders and non-responders?

One excuse that’s commonly used when a treatment shows only a small effect in proper RCTs is to assert that the treatment actually has a good effect, but only in a subgroup of patients ("responders") while others don’t respond at all ("non-responders"). For example, this argument is often used in studies of anti-depressants and of manipulative therapies. And it’s universal in alternative medicine.

There’s a striking similarity between the narrative used by homeopaths and those who are struggling to treat depression. The pill may not work for many weeks. If the first sort of pill doesn’t work try another sort. You may get worse before you get better. One is reminded, inexorably, of Voltaire’s aphorism "The art of medicine consists in amusing the patient while nature cures the disease".

There is only a handful of cases in which a clear distinction can be made between responders and non-responders. Most often what’s observed is a smear of different responses to the same treatment -and the greater the variability, the greater is the chance of being deceived by regression to the mean.

For example, Thase et al., (2011) looked at responses to escitalopram, an SSRI antidepressant. They attempted to divide patients into responders and non-responders. An example (Fig 1a in their paper) is shown.

The evidence for such a bimodal distribution is certainly very far from obvious. The observations are just smeared out. Nonetheless, the authors conclude

"Our findings indicate that what appears to be a modest effect in the grouped data – on the boundary of clinical significance, as suggested above – is actually a very large effect for a subset of patients who benefited more from escitalopram than from placebo treatment. "

I guess that interpretation could be right, but it seems more likely to be a marketing tool. Before you read the paper, check the authors’ conflicts of interest.

The bottom line is that analyses that divide patients into responders and non-responders are reliable only if that can be done before the trial starts. Retrospective analyses are unreliable and unconvincing.

Senn, 2011 provides an excellent introduction (and some interesting history). The subtitle is

"Here Stephen Senn examines one of Galton’s most important statistical legacies – one that is at once so trivial that it is blindingly obvious, and so deep that many scientists spend their whole career being fooled by it."

The examples in this paper are extended in Senn (2009), “Three things that every medical writer should know about statistics”. The three things are regression to the mean, the error of the transposed conditional and individual response.

You can read slightly more technical accounts of regression to the mean in McDonald & Mazzuca (1983) "How much of the placebo effect is statistical regression" (two quotations from this paper opened this post), and in Stephen Senn (2015) "Mastering variation: variance components and personalised medicine". In 1988 Senn published some corrections to the maths in McDonald (1983).

The trials that were used by Hróbjartsson & Gøtzsche (2010) to investigate the comparison between placebo and no treatment were looked at again by Howick et al., (2013), who found that in many of them the difference between treatment and placebo was also small. Most of the treatments did not work very well.

Regression to the mean is not just a medical deceiver: it’s everywhere

Although this post has concentrated on deception in medicine, it’s worth noting that the phenomenon of regression to the mean can cause wrong inferences in almost any area where you look at change from baseline. A classical example concern concerns the effectiveness of speed cameras. They tend to be installed after a spate of accidents, and if the accident rate is particularly high in one year it is likely to be lower the next year, regardless of whether a camera had been installed or not. To find the true reduction in accidents caused by installation of speed cameras, you would need to choose several similar sites and allocate them at random to have a camera or no camera. As in clinical trials. looking at the change from baseline can be very deceptive.

Statistical postscript

Lastly, remember that it you avoid all of these hazards of interpretation, and your test of significance gives P = 0.047. that does not mean you have discovered something. There is still a risk of at least 30% that your ‘positive’ result is a false positive. This is explained in Colquhoun (2014),"An investigation of the false discovery rate and the misinterpretation of p-values". I’ve suggested that one way to solve this problem is to use different words to describe P values: something like this.

 P > 0.05 very weak evidence P = 0.05 weak evidence: worth another look P = 0.01 moderate evidence for a real effect P = 0.001 strong evidence for real effect

But notice that if your hypothesis is implausible, even these criteria are too weak. For example, if the treatment and placebo are identical (as would be the case if the treatment were a homeopathic pill) then it follows that 100% of positive tests are false positives.

### Follow-up

12 December 2015

It’s worth mentioning that the question of responders versus non-responders is closely-related to the classical topic of bioassays that use quantal responses. In that field it was assumed that each participant had an individual effective dose (IED). That’s reasonable for the old-fashioned LD50 toxicity test: every animal will die after a sufficiently big dose. It’s less obviously right for ED50 (effective dose in 50% of individuals). The distribution of IEDs is critical, but it has very rarely been determined. The cumulative form of this distribution is what determines the shape of the dose-response curve for fraction of responders as a function of dose. Linearisation of this curve, by means of the probit transformation used to be a staple of biological assay. This topic is discussed in Chapter 10 of Lectures on Biostatistics. And you can read some of the history on my blog about Some pharmacological history: an exam from 1959.

 Maurice Nathan Saatchi, Baron Saatchi is an advertising man who, with his brother, Charles Saatchi ("‘why tell the truth when a good lie will do?), became very rich by advertising cigarettes and the Conservative party. After his second wife died of cancer he introduced a private members bill in the House of Lords in 2012. The Medical Innovation Bill came back to the Lords for its second reading on 24 October 2014.

The debate was deeply depressing: very pompous and mostly totally uninformed. You would never have guessed that the vast majority of those who understand the problem are against the bill. The Bill has failed to win the support of The British Medical Association, The Motor Neurone Disease Association, the Royal College of Physicians, the Royal College of Surgeons, the Medical Research Society, the Royal College of Radiologists, The Medical Defence Union, the Academy of Medical Sciences, the Royal College of Pathologists, the Royal College of General Practitioners, the Academy for Healthcare Science, the Wellcome Trust, Action Against Medical Accidents, and patient advocacy charities Health Watch and the Nightingale Collaboration, and others. Conservative MP Sarah Wollaston, a former GP, has “very serious concerns” about it.

Grief is not a good basis for legislation. In the Daily Telegraph, Lord Saatchi attributes the lack of a "cure for cancer" to fear of litigation.

“Any deviation by a doctor is likely to result in a verdict of guilt for medical negligence. The law defines medical negligence as deviation from that standard procedure. But as innovation is deviation, non-deviation is non-innovation. This is why there is no cure for cancer.”

This statement is utterly bizarre. Evidently Lord Saatchi knows much more about how to sell cigarettes than he does about how to discover new drugs. The reason there is no cure is that it’s a very difficult problem. It has nothing to do with litigation

Almost every medical organisation, and many lawyers, have pointed out the flaws in his ideas,. But slick, and often mendacious, advertising of his cure has deceived many of our scientifically-illiterate parliamentarians, and the bill is making progress

Lord Saatchi’s Bill would allow uncontrolled testing of treatments on any patient. It is not limited to cancer, nor to terminally ill patients (though some amendments, yet to be accepted, might change that). This sort of uncontrolled experimentation is likely to impede advances in treatment rather than to help them. And the vagueness of the wording of the bill could lead to an increase in litigation, rather than the intended decrease.

It is no coincidence that the legion of cancer quacks is in favour of the bill. It opens the door to their nonsense. Big pharma is likely to benefit too, because they will be able to sell improperly tested drugs with little or no effectiveness and immunity from prosecution if they do harm.

For more information about the Bill, see the excellent site, Stop the Saatchi Bill. There are sections on Dispelling Myths, on Professional Concerns, and on the many good articles and blogs that have pointed out the many problems with the bill.

Two recent articles are well worth reading

Saatchi’s ‘Medical Innovation Bill’ will benefit lawyers and charlatans, not patients, by neurologist David Nicholl. And it’s particularly interesting that the Telegraph’s arch-conservative, Peter Oborne has come out strongly against the bill, in The ‘Saatchi Bill’ is dangerous and will bring nothing but harm. I can’t agree with his opening words ("Lord Saatchi is rightly regarded as a national treasure. In his early days he was the advertising genius who played a fundamental role in selling the Thatcherite message"), but I agree entirely with

“The PR campaign distorts the facts, exploiting ignorance and desperation to plant false hope in the rich soil of multiple fallacies.”

“Quacks will be given free rein. No “treatment” is so loopy (or potentially dangerous) that the Saatchi Bill won’t protect doctors who prescribe or administer it from prosecution.”

“The propagation of falsehoods and fallacies surrounding and arising from this Bill will have a corrosive effect on medical ethics and society as a whole.”

Lord Saatchi, who proposed the bill said “To prevent more needless cancer deaths, doctors must be free to innovate”. This statement shows he has no idea of the efforts that go into cancer research. We are doing our best, but it is a very hard problem. In some areas (like breast cancer) there have been big advances. In others areas (e.g. pancreatic or ovarian cancer) there has not yet been any perceptible progress. It will take many more years of hard scientific work. Individual doctors tinkering with speculative untested treatments will not solve the problem.

• The only people who will benefit from the bill will be lawyers, quacks and big pharma.
• “Innovation” is undefined –the bill is based on the myth that there exists a miraculous cure waiting to be found. Sadly, the probability of this happening is vanishingly small.
• To some extent, medicine is victim of its own hype. The public feels it has a right to demand the latest miracle cure. Too often, they don’t exist.
• There is no need for the bill because doctors can already prescribe whatever they want. The Medical Defence Union says it has no reason to think that doctors are deterred from innovating by the fear of litigation.
• The bill won’t help to discover new cures –in fact it is more likely to hinder it, especially if it deters people from joining properly organised clinical trials. The bill will generate many separate anecdotes which may or may not be published. That’s the worst possible way to do research.
• The bill removes protections from patients and is more likely to increase litigation than reduce it.
• Anyone unlucky enough to get cancer is immediately a target for a legion of quacks trying to sell you crazy “treatments”. There is nothing to stop even the lunatic fringe of alternative medicine, homeopaths, promoting their sugar pills. There are, disgracefully, several hundred homeopaths with medical degrees –all a quack has to do is to ask another quack doctor to endorse their daft ideas.
• For untested treatments there is, by definition, no reason to think they’ll do more good than harm. The cancer surgeon, Michael Baum said, rightly, that in cases of terminal cancer "there will be many patients we can’t help. but none we can’t harm".

As a result of tweeting about the bill, I got a call on 21 October from RT TV (UK) asking me speak on the Saatchi Bill. That was a pleasure. Here it is (done from home, on Skype).

And on the day of the Lords debate (24 October 2014) I was asked to talk again about the Saatchi Bill, on the flagship Radio 4 morning news programme, Today. It was only a 3 minute interview with Mishal Husain, but it was unopposed so I managed to get in the main points.

Click to play interview

This is the Today Programme studio.

The BBC doesn’t pay you, but it’s good at driving you to/from the studio, though the cars are unnecessarily posh. On the way home, I had my first ever ride in an all-electric Tesla. It does 0 – 60 in 4.2 seconds but costs £50k -more than twice the price of a Prius.

### Follow-up

25 October 2014 A summary of the misunderstandings in yesterday’s House of Lords debate: What the Lords Missed.

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.

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"

### 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".

 “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.

 This is a very important book. Buy it now (that link is to Waterstone’s Amazon don’t pay tax in the UK, so don’t use them). When you’ve read it, do something about it. The book has lots of suggestions about what to do. Stolen from badscience.net

Peter Medawar, the eminent biologist, in his classic book Advice to a Young Scientist, said this.

“Exaggerated claims for the efficacy of a medicament are very seldom the consequence of any intention to deceive; they are usually the outcome of a kindly conspiracy in which everybody has the very best intentions. The patient wants to get well, his physician wants to have made him better, and the pharmaceutical company would have liked to have put it into the physician’s power to have made him so. The controlled clinical trial is an attempt to avoid being taken in by this conspiracy of good will.”

There was a lot of truth in that 1979, towards the end of the heyday of small molecule pharmacology.  Since then, one can argue, things have gone downhill.

First, though, think of life without general anaesthetics, local anaesthetics, antibiotics, anticoagulants and many others.  They work well and have done incalculable good.  And they were developed by the drug industry.

But remember also that remarkably little is known about medicine.  There are huge areas in which neither causes nor cures are known.  Treatments for chronic pain, back problems, many sorts of cancer and almost all mental problems are a mess.  It just isn’t known what to do.  Nobody is to blame for this.  Serious medical research has been going on for little more than 60 years, and it turns out to be very complicated.  We are doing our best, but are still ignorant about whole huge areas. That leads to a temptation to make things up. Clutching at straws is very evident when it comes to depression, pain and Alzheimer’s disease, among others.

In order to improve matters, one essential is to do fair tests on treatments that we have.  Ben Goldacre’s book is a superb account of how this could be done, and how the process of testing has been subverted for commercial gain and to satisfy the vanities of academics.

Of course there is nothing new in criticisms of Big Pharma.  The huge fines levied on them for false advertising are well known.  The difference is that Goldacre’s book explains clearly what’s gone wrong in great detail, documents it thoroughly, and makes concrete suggestions for improving matters.

Big Pharma has undoubtedly sometimes behaved appallingly in recent years. Someone should be in jail for crimes against patients.  They have behaved in much the same way that bankers have. In any huge globalised industry it is always possible to blame someone in another department for the dishonesty.  But they aren’t the only people to blame.  None of the problems could have arisen with the complicity of academics, universities, and a plethora of regulatory agencies and professional bodies.

The biggest scandal of all is missing data (chapter 1).  Companies, and sometmes academics, have suppressed of trials that don’t favour the drugs that they are trying to sell.  The antidepressant drug, reboxetine, appeared at first to be good. It had been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and there was at least one good randomized placebo-controlled trial (RCT) showing it worked.  But it didn’t.  The manufacturer didn’t provide a complete list of unpublished trials when asked for them.  After much work it was found in 2010 that, as well as the published, favourable trial, there were six more trials which had not been published and all six showed reboxetine to be no better than placebo .  In comparisons with other antidepressant drugs three small studies (507 patients) showed reboxetine to be as good as its competitors.  These were published. But it came to light that data on 1657 patients had never been published and these showed reboxetine to be worse than its rivals.

When all the data for the SSRI antidepressants were unearthed (Kirsch et al., 2008) it turned out that they were no better than placebo for mild or moderate depression. This selective suppression of negative data has happened time and time again. It harms patients and deceives doctors, but, incredibly, it’s not illegal.

Disgracefully, Kirsch et al. had to use a Freedom of Information Act request to get the data from the FDA.

“The output of a regulator is often simply a crude, brief summary: almost a ‘yes’ or ‘no’ about side effects. This is the opposite of science, which is only reliable because everyone shows their working, explains how they know that something is effective or safe, shares their methods and their results, and allows others to decide if they agree with the way they processed and analysed the data.”

 “the NICE document discussing whether it’s a good idea to have Lucentis, an extremely expensive drug, costing well over £ 1,000 per treatment, that is injected into the eye for a condition called acute macular degeneration. As you can see, the NICE document on whether this treatment is a good idea is censored. Not only is the data on the effectiveness of the treatment blanked out by thick black rectangles, in case any doctor or patient should see it, but absurdly, even the names of some trials are missing, preventing the reader from even knowing of their existence, or cross referencing information about them.Most disturbing of all, as you can see in the last bullet point, the data on adverse events is also censored.”

The book lists all the tricks that are used by both industry and academics. Here are some of them.

• Regulatory agencies like the MHRA, the European Medicines Agency (EMA) and the US Food and Drugs Administration (FDA) set a low bar for approval of drugs.
•  Companies make universities sign gagging agreements which allow unfavourable results to be suppressed, and their existence hidden.
• Accelerated approval schemes are abused to get quick approval of ineffective drugs and the promised proper tests often don’t materialise
• Disgracefully, even when all the results have been given to the regulatory agencies (which isn’t always). The MHRA, EMA and FDA don’t make them public. We are expected to take their word.
• Although all clinical trials are meant to be registered before they start, the EMA register, unbelievably, is not public.  Furthermore there is no check that the results if trials ever get published.  Despite mandates that results must be published within a year of finishing the trial, many aren’t.  Journals promise to check this sort of thing, but they don’t.
• When the results are published, it is not uncommon for the primary outcome, specified before it started, to have been changed to one that looks like a more favourable result.  Journals are meant to check, but mostly don’t.
• Companies use scientific conferences, phony journals, make-believe “seed trials” and “continuing medical education” for surreptitious advertising.
• Companies invent new diseases, plant papers to make you think you’re abnormal, and try to sell you a “cure”.  For example, female sexual dysfunction , restless legs syndrome and social anxiety disorder (i.e. shyness).  This is called disease-mongering, medicalisation or over-diagnosis. It’s bad.
• Spin is rife. Companies, and authors, want to talk up their results. University PR departments want to exaggerate benefits. Journal editors want sensational papers. Read the results, not the summary. This is universal (but particularly bad in alternative medicine).
• Companies fund patient groups to lobby for pills even when the pills are known to be ineffective.  The lobby that demanded that Herceptin should be available to all on the breast cancer patients on the NHS was organised by a PR company working for the manufacturer, Roche.  But Herceptin doesn’t work at all in 80% of patients and gives you at best a few extra months of  life in advanced cases.
• Ghostwriting of papers is serious corruption.  A company writes the paper and senior academics appear as the authors, though they may never have seen the original data.  Even in cases where academics have admitted to lying about whether they have seen the data, they go unpunished by their universities. See for example, the case of Professor Eastell.
• By encouraging the funding of “continuing medical education” by companies, the great and the good of academic medicine have let us down badly.

This last point is where the book ends, and it’s worth amplification.

“So what have the great and good of British medicine done to help patients, in the face of this endemic corruption, and these systematic flaws? In 2012, a collaborative document was produced by senior figures in medicine from across the board, called ‘Guidance on Collaboration Between Healthcare Professionals and the Pharmaceutical Industry’. This document was jointly approved by the ABPI, the Department of Health, the Royal Colleges of Physicians, Nursing, Psychiatrists, GPs, the Lancet, the British Medical Association, the NHS Confederation, and so on. ”

“It contains no recognition of the serious problems we have seen in this book. In fact, quite the opposite: it makes a series of assertions about them that are factually incorrect.”

“It states that drug reps ‘can be a useful resource for healthcare professionals’. Again, I’m not sure why the Royal Colleges, the BMA, the Department of Health and the NHS Confederation felt the need to reassert this to the doctors of the UK, on behalf of industry, when the evidence shows that drug reps actively distort prescribing practices. But that is the battle you face, trying to get these issues taken seriously by the pinnacle of the medical establishment.”

This is perhaps the most shameful betrayal of all.  The organisations that should protect patients have sold them out.

You may have been sold out by your “elders and betters”, but you can do something. The “What to do” sections of the book should be produced as a set of flash cards, as a reminder that matters can be improved.

It is shameful that this book was not written by a clinical pharmacologist, or a senior doctor, or a Royal College, or a senior academic.  Why has the British Pharmacological Society said nothing?

### Follow-up

The comments that appeared in The Atlantic on this piece were mostly less than enlightening -not quite what one expected of an intellectual magazine. Nevertheless I tried to answer all but the plain abusive comments.

More interesting, though, was an editorial by Jennie Rothenberg Gritz, the Atlantic Senior Editor who asked me to contribute. The Man Who Invented Medical School. It picked up on my mention of Abraham Flexner, and his famous 1910 report [download from Carnegie Foundation] which first put US medial education on a form rational footing. based on science. Now, 100 years later that’s being unpicked both in the USA and here. ms Gritz seemed to think that Flexner would have approved of Dean Ornish. In a response I begged to differ. I’m pretty sure that Felxner would have been furious of he could have seen the reecent march of quackademia, particularly, but not exclusively, in the USA. It is exactly the sort of thing his report set out, successfully, to abolish. He wrote, for example,

“the practitioner is subjected, year in, year out, to the steady bombardment of the unscrupulous manufacturer, persuasive to the uncritical, on the principle that “what I tell you three times is true.” Against bad example and persistent asseveration, only precise scientific concepts and a critical
appreciation of the nature and limits of actual demonstration can protect the young physician.” (Flexner report, 1910, pp 64-65)

It is this very “appreciation of the nature and limits of actual demonstration” that is now being abandoned by the alternative medicine industry. despite the fact that real medicine was in its infancy at the time he w as writing, he was very perceptive about the problems. Perhaps Freedman should read the report.

David Katz seems to have spotted my piece in The Atlantic, and has responded at great length in the Huffington Post (quite appropriate, given the consistent support of HuffPo for nonsense medicine). HuffPo allows only short comments with no links so I’ll reply to him here.

I fear that Dr Katz doth protest a great deal too much. He seems to object to a comment that I made about him in The Atlantic.

“… [He] listed a lot of things he’d tried and which failed to work. His conclusion was not that they should be abandoned, but that we needed a ‘a more fluid concept of evidence.'”

You don’t have to take my word for it. You can take it from the words of Dr Katz.

"What do we do when the evidence we have learned, or if we care to be more provocative, with which we have been indoctrinated, does now fully meet the needs of our patients"

It seems odd to me to regard teaching about how you distinguish what;s true and what isn’t as "indoctrination", though I can understand that knowledge of that subject could well diminish the income of alternative practitioners. You went on to say

"Some years ago the CDC funded us with a million dollars to do what they referred to initially as a systematic review of the evidence base for complementary and alternative medicine,  Anybody who’s ever been involved in systematic reviews knows that’s a very silly thing. . . . Well we knew it was silly but a million dollars sounded real [mumbled] took the money and then we figurered we’d figure out what to do with it [smiles broadly]. That’s what we did ". . .

I do hope you told the CDC that you did not spend the million dollars for the sensible purpose for which it was awarded.

This infusion of calcium, magnesium and D vitamins and vitamin C ameliorates the symptoms of fibromyalgia.  . . .  We did typical placebo controlled randomized double-blind trial for several months . . . we saw an improvement in both our treatment and placebo groups . . .

You then describe how you tested yoga for asthma and homeopathy for attention deficit hyperactivity disorder, Neither of them worked either. Your reaction to this string of failures was just to say “we need a more fluid concept of evidence”

After telling an anecdote about one patient who got better after taking homeopathic treatment you said £I don’t care to get into a discussion of how, or even whether, homeopathy works”.  Why not?  It seems it doesn’t matter much to you whether the things you sell to patients work or not.

You then went on to describe quite accurately that anti-oxidants don’t work and neither do multivitamin supplements for prevention of cardiovascular problems,  And once again you fail to accept the evidence, even evidence you have found yourself. Your response was

“So here too is an invitation to think more fluidly about of evidence. Absence of evidence is not evidence of absence.”

That last statement is the eternal cry of every quack.  It’s true, of course, but that does not mean that absence of evidence gives you a licence to invent the answer.  But inventing the answer is what you do, time after time, You seem quite incapable of saying the most important thing that anyone in your position should. I don’t know the answer.

One wonders about the standards of peer review at the British Journal of General Practice. The June issue has a paper, "Acupuncture for ‘frequent attenders’ with medically unexplained symptoms: a randomised controlled trial (CACTUS study)". It has lots of numbers, but the result is very easy to see. Just look at their Figure.

There is no need to wade through all the statistics; it’s perfectly obvious at a glance that acupuncture has at best a tiny and erratic effect on any of the outcomes that were measured.

But this is not what the paper said. On the contrary, the conclusions of the paper said

 Conclusion The addition of 12 sessions of five-element acupuncture to usual care resulted in improved health status and wellbeing that was sustained for 12 months.

How on earth did the authors manage to reach a conclusion like that?

The first thing to note is that many of the authors are people who make their living largely from sticking needles in people, or advocating alternative medicine. The authors are Charlotte Paterson, Rod S Taylor, Peter Griffiths, Nicky Britten, Sue Rugg, Jackie Bridges, Bruce McCallum and Gerad Kite, on behalf of the CACTUS study team. The senior author, Gerad Kite MAc , is principal of the London Institute of Five-Element Acupuncture London. The first author, Charlotte Paterson, is a well known advocate of acupuncture. as is Nicky Britten.

The conflicts of interest are obvious, but nonetheless one should welcome a “randomised controlled trial” done by advocates of alternative medicine. In fact the results shown in the Figure are both interesting and useful. They show that acupuncture does not even produce any substantial placebo effect. It’s the authors’ conclusions that are bizarre and partisan. Peer review is indeed a broken process.

That’s really all that needs to be said, but for nerds, here are some more details.

How was the trial done?

The description "randomised" is fair enough, but there were no proper controls and the trial was not blinded. It was what has come to be called a "pragmatic" trial, which means a trial done without proper controls. They are, of course, much loved by alternative therapists because their therapies usually fail in proper trials. It’s much easier to get an (apparently) positive result if you omit the controls. But the fascinating thing about this study is that, despite the deficiencies in design, the result is essentially negative.

The authors themselves spell out the problems.

“Group allocation was known by trial researchers, practitioners, and patients”

So everybody (apart from the statistician) knew what treatment a patient was getting. This is an arrangement that is guaranteed to maximise bias and placebo effects.

"Patients were randomised on a 1:1 basis to receive 12 sessions of acupuncture starting immediately (acupuncture group) or starting in 6 months’ time (control group), with both groups continuing to receive usual care."

So it is impossible to compare acupuncture and control groups at 12 months, contrary to what’s stated in Conclusions.

"Twelve sessions, on average 60 minutes in length, were provided over a 6-month period at approximately weekly, then fortnightly and monthly intervals"

That sounds like a pretty expensive way of getting next to no effect.

"All aspects of treatment, including discussion and advice, were individualised as per normal five-element acupuncture practice. In this approach, the acupuncturist takes an in-depth account of the patient’s current symptoms and medical history, as well as general health and lifestyle issues. The patient’s condition is explained in terms of an imbalance in one of the five elements, which then causes an imbalance in the whole person. Based on this elemental diagnosis, appropriate points are used to rebalance this element and address not only the presenting conditions, but the person as a whole".

Does this mean that the patients were told a lot of mumbo jumbo about “five elements” (fire earth, metal, water, wood)? If so, anyone with any sense would probably have run a mile from the trial.

"Hypotheses directed at the effect of the needling component of acupuncture consultations require sham-acupuncture controls which while appropriate for formulaic needling for single well-defined conditions, have been shown to be problematic when dealing with multiple or complex conditions, because they interfere with the participative patient–therapist interaction on which the individualised treatment plan is developed. 37–39 Pragmatic trials, on the other hand, are appropriate for testing hypotheses that are directed at the effect of the complex intervention as a whole, while providing no information about the relative effect of different components."

Put simply that means: we don’t use sham acupuncture controls so we can’t distinguish an effect of the needles from placebo effects, or get-better-anyway effects.

"Strengths and limitations: The ‘black box’ study design precludes assigning the benefits of this complex intervention to any one component of the acupuncture consultations, such as the needling or the amount of time spent with a healthcare professional."

"This design was chosen because, without a promise of accessing the acupuncture treatment, major practical and ethical problems with recruitment and retention of participants were anticipated. This is because these patients have very poor self-reported health (Table 3), have not been helped by conventional treatment, and are particularly desperate for alternative treatment options.".

It’s interesting that the patients were “desperate for alternative treatment”. Again it seems that every opportunity has been given to maximise non-specific placebo, and get-well-anyway effects.

There is a lot of statistical analysis and, unsurprisingly, many of the differences don’t reach statistical significance. Some do (just) but that is really quite irrelevant. Even if some of the differences are real (not a result of random variability), a glance at the figures shows that their size is trivial.

My conclusions

(1) This paper, though designed to be susceptible to almost every form of bias, shows staggeringly small effects. It is the best evidence I’ve ever seen that not only are needles ineffective, but that placebo effects, if they are there at all, are trivial in size and have no useful benefit to the patient in this case..

(2) The fact that this paper was published with conclusions that appear to contradict directly what the data show, is as good an illustration as any I’ve seen that peer review is utterly ineffective as a method of guaranteeing quality. Of course the editor should have spotted this. It appears that quality control failed on all fronts.

### Follow-up

In the first four days of this post, it got over 10,000 hits (almost 6,000 unique visitors).

Margaret McCartney has written about this too, in The British Journal of General Practice does acupuncture badly.

The Daily Mail exceeds itself in an article by Jenny Hope whch says “Millions of patients with ‘unexplained symptoms’ could benefit from acupuncture on the NHS, it is claimed”. I presume she didn’t read the paper.

The Daily Telegraph scarcely did better in Acupuncture has significant impact on mystery illnesses. The author if this, very sensibly, remains anonymous.

Many “medical information” sites churn out the press release without engaging the brain, but most of the other newspapers appear, very sensibly, to have ignored ther hyped up press release. Among the worst was Pulse, an online magazine for GPs. At least they’ve publish the comments that show their report was nonsense.

The Daily Mash has given this paper a well-deserved spoofing in Made-up medicine works on made-up illnesses.

“Professor Henry Brubaker, of the Institute for Studies, said: “To truly assess the efficacy of acupuncture a widespread double-blind test needs to be conducted over a series of years but to be honest it’s the equivalent of mapping the DNA of pixies or conducting a geological study of Narnia.” ”

There is no truth whatsoever in the rumour being spread on Twitter that I’m Professor Brubaker.

Euan Lawson, also known as Northern Doctor, has done another excellent job on the Paterson paper: BJGP and acupuncture – tabloid medical journalism. Most tellingly, he reproduces the press release from the editor of the BJGP, Professor Roger Jones DM, FRCP, FRCGP, FMedSci.

"Although there are countless reports of the benefits of acupuncture for a range of medical problems, there have been very few well-conducted, randomised controlled trials. Charlotte Paterson’s work considerably strengthens the evidence base for using acupuncture to help patients who are troubled by symptoms that we find difficult both to diagnose and to treat."

Oooh dear. The journal may have a new look, but it would be better if the editor read the papers before writing press releases. Tabloid journalism seems an appropriate description.

Andy Lewis at Quackometer, has written about this paper too, and put it into historical context. In Of the Imagination, as a Cause and as a Cure of Disorders of the Body. “In 1800, John Haygarth warned doctors how we may succumb to belief in illusory cures. Some modern doctors have still not learnt that lesson”. It’s sad that, in 2011, a medical journal should fall into a trap that was pointed out so clearly in 1800. He also points out the disgracefully inaccurate Press release issued by the Peninsula medical school.

Some tweets

Twitter info 426 clicks on http://bit.ly/mgIQ6e alone at 15.30 on 1 June (and that’s only the hits via twitter). By July 8th this had risen to 1,655 hits via Twitter, from 62 different countries,

@followthelemur Selina
MASSIVE peer review fail by the British Journal of General Practice http://bit.ly/mgIQ6e (via @david_colquhoun)

@david_colquhoun David Colquhoun
Appalling paper in Brit J Gen Practice: Acupuncturists show that acupuncture doesn’t work, but conclude the opposite http://bit.ly/mgIQ6e
Retweeted by gentley1300 and 36 others

@david_colquhoun David Colquhoun.
I deny the Twitter rumour that I’m Professor Henry Brubaker as in Daily Mash http://bit.ly/mt1xhX (just because of http://bit.ly/mgIQ6e )

@brunopichler Bruno Pichler
http://tinyurl.com/3hmvan4
Made-up medicine works on made-up illnesses (me thinks Henry Brubaker is actually @david_colquhoun)

@david_colquhoun David Colquhoun,
HEHE RT @brunopichler: http://tinyurl.com/3hmvan4 Made-up medicine works on made-up illnesses

@psweetman Pauline Sweetman
Read @david_colquhoun’s take on the recent ‘acupuncture effective for unexplained symptoms’ nonsense: bit.ly/mgIQ6e

@bodyinmind Body In Mind
RT @david_colquhoun: ‘Margaret McCartney (GP) also blogged acupuncture nonsense http://bit.ly/j6yP4j My take http://bit.ly/mgIQ6e’

@abritosa ABS
Br J Gen Practice mete a pata na poça: RT @david_colquhoun […] appalling acupuncture nonsense http://bit.ly/j6yP4j http://bit.ly/mgIQ6e

amusing!RT @david_colquhoun: paper in Brit J Gen Practice shows that acupuncture doesn’t work,but conclude the opposite http://bit.ly/mgIQ6e

@kashfarooq Kash Farooq
Unbelievable: acupuncturists show that acupuncture doesn’t work, but conclude the opposite. http://j.mp/ilUALC by @david_colquhoun

@NeilOConnell Neil O’Connell
Gobsmacking spin RT @david_colquhoun: Acupuncturists show that acupuncture doesn’t work, but conclude the opposite http://bit.ly/mgIQ6e

@euan_lawson Euan Lawson (aka Northern Doctor)
Aye too right RT @david_colquhoun @iansample @BenGoldacre Guardian should cover dreadful acupuncture paper http://bit.ly/mgIQ6e

@noahWG Noah Gray
Acupuncturists show that acupuncture doesn’t work, but conclude the opposite, from @david_colquhoun: http://bit.ly/l9KHLv

8 June 2011 I drew the attention of the editor of BJGP to the many comments that have been made on this paper. He assured me that the matter would be discussed at a meeting of the editorial board of the journal. Tonight he sent me the result of this meeting.

 Subject: BJGP From: “Roger Jones” To: Dear Prof Colquhoun We discussed your emails at yesterday’s meeting of the BJGP Editorial Board, attended by 12 Board members and the Deputy Editor The Board was unanimous in its support for the integrity of the Journal’s peer review process for the Paterson et al paper – which was accepted after revisions were made in response to two separate rounds of comments from two reviewers and myself – and could find no reason either to retract the paper or to release the reviewers’ comments Some Board members thought that the results were presented in an overly positive way; because the study raises questions about research methodology and the interpretation of data in pragmatic trials attempting to measure the effects of complex interventions, we will be commissioning a Debate and Analysis article on the topic. In the meantime we would encourage you to contribute to this debate throught the usual Journal channels Roger Jones Professor Roger Jones MA DM FRCP FRCGP FMedSci FHEA FRSA Editor, British Journal of General Practice Royal College of General Practitioners One Bow Churchyard London EC4M 9DQ Tel +44 203 188 7400

It is one thing to make a mistake, It is quite another thing to refuse to admit it. This reply seems to me to be quite disgraceful.

20 July 2011. The proper version of the story got wider publicity when Margaret McCartney wrote about it in the BMJ. The first rapid response to this article was a lengthy denial by the authors of the obvious conclusion to be drawn from the paper. They merely dig themselves deeper into a hole. The second response was much shorter (and more accurate).

 Thank you Dr McCartney Richard Watson, General Practitioner Glasgow The fact that none of the authors of the paper or the editor of BJGP have bothered to try and defend themselves speaks volumes. Like many people I glanced at the report before throwing it away with an incredulous guffaw. You bothered to look into it and refute it – in a real journal. That last comment shows part of the problem with them publishing, and promoting, such drivel. It makes you wonder whether anything they publish is any good, and that should be a worry for all GPs.

30 July 2011. The British Journal of General Practice has published nine letters that object to this study. Some of them concentrate on problems with the methods. others point out what I believe to be the main point, there us essentially no effect there to be explained. In the public interest, I am posting the responses here [download pdf file]

Thers is also a response from the editor and from the authors. Both are unapologetic. It seems that the editor sees nothing wrong with the peer review process.

I don’t recall ever having come across such incompetence in a journal’s editorial process.

Here’s all he has to say.

 The BJGP Editorial Board considered this correspondence recently. The Board endorsed the Journal’s peer review process and did not consider that there was a case for retraction of the paper or for releasing the peer reviews. The Board did, however, think that the results of the study were highlighted by the Journal in an overly-positive manner. However,many of the criticisms published above are addressed by the authors themselves in the full paper.

If you subscribe to the views of Paterson et al, you may want to buy a T-shirt that has a revised version of the periodic table.

5 August 2011. A meeting with the editor of BJGP

Yesterday I met a member of the editorial board of BJGP. We agreed that the data are fine and should not be retracted. It’s the conclusions that should be retracted. I was also told that the referees’ reports were "bland". In the circumstances that merely confirmed my feeling that the referees failed to do a good job.

Today I met the editor, Roger Jones, himself. He was clearly upset by my comment and I have now changed it to refer to the whole editorial process rather than to him personally. I was told, much to my surprise, that the referees were not acupuncturists but “statisticians”. That I find baffling. It soon became clear that my differences with Professor Jones turned on interpretations of statistics.

It’s true that there were a few comparisons that got below P = 0.05, but the smallest was P = 0.02. The warning signs are there in the Methods section: "all statistical tests were …. deemed to be statistically significant if P < 0.05". This is simply silly -perhaps they should have read Lectures on Biostatistics. Or for a more recent exposition, the XKCD cartoon in which it’s proved that green jelly beans are linked to acne (P = 0.05). They make lots of comparisons but make no allowance for this in the statistics. Figure 2 alone contains 15 different comparisons: it’s not surprising that a few come out "significant", even if you don’t take into account the likelihood of systematic (non-random) errors when comparing final values with baseline values.

Keen though I am on statistics, this is a case where I prefer the eyeball test. It’s so obvious from the Figure that there’s nothing worth talking about happening, it’s a waste of time and money to torture the numbers to get "significant" differences. You have to be a slavish believer in P values to treat a result like that as anything but mildly suggestive. A glance at the Figure shows the effects, if there are any at all, are trivial.

I still maintain that the results don’t come within a million miles of justifying the authors’ stated conclusion “The addition of 12 sessions of five-element acupuncture to usual care resulted in improved health status and wellbeing that was sustained for 12 months.” Therefore I still believe that a proper course would have been to issue a new and more accurate press release. A brief admission that the interpretation was “overly-positive”, in a journal that the public can’t see, simply isn’t enough.

I can’t understand either, why the editorial board did not insist on this being done. If they had done so, it would have been temporarily embarrassing, certainly, but people make mistakes, and it would have blown over. By not making a proper correction to the public, the episode has become a cause célèbre and the reputation oif the journal will suffer permanent harm. This paper is going to be cited for a long time, and not for the reasons the journal would wish.

Misinformation, like that sent to the press, has serious real-life consequences. You can be sure that the paper as it still stands, will be cited by every acupuncturist who’s trying to persuade the Department of Health that he’s a "qualified provider".

There was not much unanimity in the discussion up to this point, Things got better when we talked about what a GP should do when there are no effective options. Roger Jones seemed to think it was acceptable to refer them to an alternative practitioner if that patient wanted it. I maintained that it’s unethical to explain to a patient how medicine works in terms of pre-scientific myths.

I’d have love to have heard the "informed consent" during which "The patient’s condition is explained in terms of imbalance in the five elements which then causes an imbalance in the whole person". If anyone had tried to explain my conditions in terms of my imbalance in my Wood, Water, Fire, Earth and Metal. I’d think they were nuts. The last author. Gerad Kite, runs a private clinic that sells acupuncture for all manner of conditions. You can find his view of science on his web site. It’s condescending and insulting to talk to patients in these terms. It’s the ultimate sort of paternalism. And paternalism is something that’s supposed to be vanishing in medicine. I maintained that this was ethically unacceptable, and that led to a more amicable discussion about the possibility of more honest placebos.

It was good of the editor to meet me in the circumstances. I don’t cast doubt on the honesty of his opinions. I simply disagree with them, both at the statistical level and the ethical level.

30 March 2014

I only just noticed that one of the authors of the paper, Bruce McCallum (who worked as an acupuncturist at Kite’s clinic) appeared in a 2007 Channel 4 News piece. I was a report on the pressure to save money by stopping NHS funding for “unproven and disproved treatments”. McCallum said that scientific evidence was needed to show that acupuncture really worked. Clearly he failed, but to admit that would have affected his income.

Watch the video (McCallum appears near the end).

One of my first posts about nonsense taught in universities was about the University of Westminster (April 2008): Westminster University BSc: “amethysts emit high yin energy”. since then, there have been several more revelations.

 Professor Petts The vice-cnancellor of Westminster, Professor Geoffrey Petts, with whom the buck stops, did have an internal review but its report was all hot air and no action resulted (see A letter to the Times, and Progress at Westminster). That earned Professor Petts an appearence in Private Eye Crystal balls. Professor Petts in Private Eye (and it earned me an invitation to a Private Eye lunch, along with Francis Wheen, Charlie Booker, Ken Livingstone . . ). It also earned Petts an appearence in the Guardian (The opposite of science).

By that time Salford University had closed down all its CAM, and the University of Central Lancashire was running an honest internal review which resulted in closure of (almost) all of their nonsense degrees. But Westminster proved more resistant to sense and, although they closed down homeopathy, they still remain the largest single provider of degrees in junk medicine. See, for example More make-believe from the University of Westminster. This time it’s Naturopathy, and
The last BSc (Hons) Homeopathy closes! But look at what they still teach at Westminster University.

It’s interesting that Westminster always declined to comply with Freedom of Information requests, yet I had more from them than from most places. All the information about what’s taught at Westminster came from leaks from within the university. Westminster has more moles than a suburban garden. They were people with conscience who realised that the university was harming itself. They would claim that they were trying to save the university from some remarkably bad management. I claim also that I’m working in the interests of the university.

In the wake of the victory at the Information Tribunal, I sent a Freedom of Information Act (FOIA) request for for samples of teaching materials from all of their courses. This time they couldn’t legally refuse. The first batch has just arrived, so here are a few selected gems of utter nonsense. Well, it is worse than nonsense because it endangers the health of sick people.

### A letter to the university from a student

Before getting on to the slides, here’s a letter that was supplied under FOIA. It was sent anonymously to the university. I was told that this was the only letter of complaint but I happen to know that’s not true so I’ve asked again. This one was forwarded to the vice-chancellor in 2008, and to the review committee. Both seem to have ignored it. Judging from the wording, one would guess that it came from one of their own undergraduates. :Here are some extracts.[download whole letter]

 It is a flagrant contradiction of a ‘science’ in the BSc to have these practices, but it also jeopardises our profession, which is under DoH review and being constantly attacked in the media Gustifiable I suggest). We are taught that simply tasting plant tinctures can tell us which part of the body they work. on and what they do in the body. We are given printed charts with an outline of the body on to record our findings on. This is both nonsense, but is dangerous as it implies that the pharmacology of plant tinctures can be divined by taste alone. In class we are taught that we can divine the drug actions or use of an unknown plant simply by tasting an alcohol extract. Science? or dangerous fantasy. There are lecturers taking clinics who allow students to dowse and partake themselves in dowsing or pendulums to diagnose and even to test suitability of plant drugs. Dowsing is taught to us by some lecturers and frowned upon by others but we feel it brings the herbal medicine into a poor light as it is unscientific and bogus nonsense. We are concerned that we have seen the course leader brush over this practice as though she is frightened to make a stand.

The letter seems to refer to a course in herbal medicine. That is a subject that could be studied scientifically, though to do so would leave students unemployed because so few herbal treatments have been shown to work. It obviously is not being studied scientifically: but even teaching students about dowsing and pendulums does not seem to have stirred the vice-chancellor into action.

### David Peters: wishful thinking?

David Peters is a nice man. He’s the Clinical Director of Westminster’s School of Integrated Health. I debated with him on the excellent Radio 4 Programme, Material World.

His lecture on "Complementary Healthcare in the NHS" showed some fine wishful thinking.

It shows the progress of the euphemisms that quacks use to try to gain respectability, but little else. Interestingly, later slides show a bit more realism.

So he has noticed that the tide has turned and that a lot of people are no longer willing to be palmed off with new age gobbledygook. And yes, courses are shutting. Perhaps his course will be the next to shut?

According to an internal Westminster email that found its way to me,

The following courses have been closed/identified for closure due to poor recruitment :

• BSc degrees in Homeopathy and Remedial Massage & Neuromuscular Therapy, students completing by September 2011
• MA degrees in International Community development, Community development and Faith-based Community development, students completing by September 2011
• BSc degree Complementary Medicine
• Graduate diploma BMS

The following courses have been identified as ‘at risk’ (School definition) and will be discussed at the APRG and University Review Group2, due to poor recruitment and high cost of delivery:

• Integrated Health Scheme: BSc Complementary Medicine, Naturopathy; BSc Chinese Medicine; BSc Nutritional Therapy; BSc Herbal Medicine

### The BSc (Hons) degree in naturopathy

Naturopathy us pretty bizarre, because it consists largely of doing nothing at all, beyond eating vegetables . Being ill is good for you.

Perhaps the best source to judge claims is the US National Center for Complementary and Alternive Medicine (NCCAM), a branch of the National Institutes of Health. This is the outfit that has spent over a billion dollars of US taxpayers’ money testing alternative medicines and for all that money has not come up with a single useful treatment. They never link to any sort of critical comment, and are nothing if not biassed towards all things alternative. If they can’t come up with evidence. nobody can. Two useful links to NCCAM are Herbs at a glance, and Health Topics A – Z.

Uses of herbal teas in naturopathic dietary care

I was sent a set of over 50 slides on "Herbal Teas/Decoctions (3CMWS03, 1/02, Uses of herbal teas in naturopathic dietary care). About half of them amount to little more than ‘how to make a cup of tea’. but then we get onto uses, but then a lot of fantasy ensues.

What NNCAM says about dandelion. There is no compelling scientific evidence for using dandelion as a treatment for any medical condition.

What Westminster says

Well I know what a diuretic is, but "blood purifier" and "liver tonic" are meaningless gobbledygook. We’ve been through this before with Red Clover (see Michael Quinion’s .look at the term "blood cleanser"). Using words like them is the very opposite of education.

What NCCAM says.about chamomile: Chamomile has not been well studied in people so there is little evidence to support its use for any condition.

What Westminster says

So, judging by NCCAM, these claims are unjustified. It’s teaching folk-lore as though it meant something.

More dangerous advice comes when we get to the ‘repertories’.

Infections can kill you, They are one of the modest number of things that pharmacology can usually cure, rather than treat symptomatically. If you go to a Westminster-trained naturopath with a serious infection and follow their advice to put garlic in your socks, you will not just be smelly, You could die.

Allergy and Intolerance 3CMwS03 18/02

 Treating allergies, misdiagnosed by fraudulent tests, is very big business for the ‘health food industry’, This lecture, by R. Newman Turner ND, DO, BAc, started tolerably but descended to a nadir when it mentions, apparently seriously, two of the best known fraudulent methods of allergy diagnosis, the Vega test and "Applied Kinesiology". Kinesiology Sounds sort of sciencey, but Applied Kinesiology is actually a fraudulent and totally ineffective diagnostic method invented by (you guessed) a chiropractor.   It has been widely used by alternative medicine to misdiagnose food allergies. It does not work (Garrow, 1988: download reprint).

Could this be the same R Newman Turner who wrote a book on Naturopathic First Aid? The mind boggles.

Naturopathic Detoxification 23 CMES03 25/02 Detox Myth of Fact

 This lecture was the responsibility of Irving S Boxer ND DO MRN LCH, a naturopath, homeopath and osteopath in private practice. Don’t be fooled by the implied question in the title. It might have been taken to suggest a critical approach. Think again. There is all the usual make-believe about unspecified and imaginary toxins that you must get rid of with enemas and vegetables.

 The skin brushing does not quite plumb the depths of Jacqueline Young’s Taking an air bath , but presumably it is something similar. "Liver activation" by castor oil packs is pure unadulterated gobblydygook. The words mean nothing. Their attempt to divide all foods into those that cleanse and those that clog sounds reminiscent of the Daily Mail’s ontological oncology project.

The practice of healing (3CMSS01 2/12)

Next we retreat still further into fantasy land

All pure hokum, of course’ She could have added "craniosacral therapy" (at present the subject of a complaint against the UCL Hospitals Trust (that’s the NHS, not UCL) to the Advertising Standards Authority,

Is that definition quite clear?

In fact this sort of nonsense about rays coming from your hands was disproved experimentally, in a rather famous paper, the only paper in the Journal of the American Medical Association to have been written by a 9-year old. Emily Rosa. She (with some help from her parents) devised a simple test for her 4th (US) grade science fair project. It was later repeated under more controlled conditions and written up for JAMA [download reprint] . It showed that the claims of ‘therapeutic touch" practitioners to be able to detect "auras" were totally false. No subsequent work has shown otherwise. Why, then, does the University of Westminster teach it as part of a Bachelor of Science degree?

You can see Emily Rosa herself explain why “therapeutic touch is bullshit” with Penn and Teller, in Penn and Teller Expose Therapeutic Touch.

Environmental stress

The last bit of hokum (for the moment) is one of the best. This one has every myth under the sun (including some I hadn’t heard of).

 The lecturer, Val Bullen, was also responsible for the infamous "Amethysts emit high Yin energy" slide. One of her own students desribes her as "sweet but deluded". I have nothing against Ms Bullen, She can believe whatever she wants. My problem is with the vice-chancellor, Prof Geoffrey Petts, who seems to think that this sort of stuff is appropriate for a BSc.

 Everything barmy is here. Mobile phones, power lines, underwater streams, ley lines, sick building syndrome, are all reasons why you don’t feel 100 percent, Actually my reason is having to read this junk. The "definitions" are, as always, just meaningless words.

But don’t despair. Help is at hand.

Just in case you happen to have run out of Alaskan Calling All Angels Essence, you can buy it from Baldwin’s for £19.95. It’s "designed to invoke the nurturing, uplifting and joyful qualities of the angelic kingdom.", and what’s more "can also use them any time to cleanse, energize, and protect your auric field." Well that’s what it says.in the ad.

Yarrow Environmental Solution looks like good stuff too. Only £7.95 for 7.5 ml. For that you get a lot. It will

" . . strengthen and protect against toxic environmental influences, geopathic stress, and other hazards of technology-dominated modern life. This includes the disruptive effects of radiation on human energy fields from X-rays, televisions, computer monitors, electromagnetic fields, airplane flights or nuclear fall-out."

OK stop giggling. This is serious stuff, taught in a UK university as part of a BSc degree, and awarded a high score by the Quality Assurance Agency (QAA).

Professor Petts, are you listening? I believe it is you, not I, who is bringing your university into disrepute.

The slides shown here are copyright of the University of Westminster or of the author of the lecture. They are small sample of what I was sent and are reproduced under the “fair quotation” provision, in the public interest.

### Follow-up

5 May 2011. By sheer coincidence, Emily and Linda Rosa were passing through London. They called for lunch and here’s a picture (with Ben Goldacre) in UCL’s (endangered) Housman room. Linda kindly gave me a copy of her book Attachment Therapy on Trial: The Torture and Death of Candace Newmaker. [Download reprint of Rosa’s paper..]

.

6 May 2011. Talking of the “vibrational medicine” fantasy, I had an email that pointed out a site that plumbs new depths in fantasy physics. It’s on the PositiveHealthOnline website: A post there, Spirals and Energy in Nature, was written by Robert McCoy. He claims to have worked on microprocessor layout design, but anyone with school physics could tell that the article is sheer nonsense. In a way it is much more objectionable that the silly slides with coloured rays used in the Westminster course. McCoy’s post seeks to blind with sciencey-sounding language, that in fact makea no sense at all. Luckily my retweet of the site attracted the attention of a real physicist, A.P. Gaylard, who made a very welcome return to blogging with Fantasy physics and energy medicine. He dismantles the physics, line-by-line, in a devastating critique. This sort of junk physics is far more dangerous than the perpetual motion pundits and the cold-fusion fantasists. At PositiveHealthOnline it is being used to push pills that do you no good and may harm you. It is a danger to public health.

This is a slightly-modified version of the article that appeared in BMJ blogs yesterday, but with more links to original sources, and a picture. There are already some comments in the BMJ.

The original article, diplomatically, did not link directly to UCL’s Grand Challenge of Human Wellbeing, a well-meaning initiative which, I suspect, will not prove to be value for money when it comes to practical action.

Neither, when referring to the bad effects of disempowerment on human wellbeing (as elucidated by, among others, UCL’s Michael Marmot), did I mention the several ways in which staff have been disempowered and rendered voiceless at UCL during the last five years. Although these actions have undoubtedly had a bad effect on the wellbeing of UCL’s staff, it seemed a litlle unfair to single out UCL since similar things are happening in most universities. Indeed the fact that it has been far worse at Imperial College (at least in medicine) has probably saved UCL from being denuded. One must be thankful for small mercies.

There is, i think, a lesson to be learned from the fact that formal initiatives in wellbeing are springing up at a time when university managers are set on taking actions that have exactly the opposite effect. A ‘change manager’ is not an adequate substitute for a vote.  Who do they imagine is being fooled?

Click logo to go to BMJ

The A to Z of the wellbeing industry
From angelic reiki to patient-centred care

Nobody could possibly be against wellbeing. It would be like opposing motherhood and apple pie. There is a whole spectrum of activities under the wellbeing banner, from the undoubtedly well-meaning patient-centred care at one end, to downright barmy new-age claptrap at the other end.  The only question that really matters is, how much of it works?

Let’s start at the fruitcake end of the spectrum.

One thing is obvious. Wellbeing is big business. And if it is no more than a branch of the multi-billion-dollar positive-thinking industry, save your money and get on with your life.

In June 2010, Northamptonshire NHS Foundation Trust sponsored a “Festival of Wellbeing” that included a complementary therapy taster day. In a BBC interview one practitioner used the advertising opportunity, paid for by the NHS, to say “I’m an angelic reiki master teacher and also an angel therapist.” “Angels are just flying spirits, 100 percent just pure light from heaven. They are all around us. Everybody has a guardian angel.” Another said “I am a member of the British Society of Dowsers and use a crystal pendulum to dowse in treatment sessions. Sessions may include a combination of meditation, colour breathing, crystals, colour scarves, and use of a light box.” You couldn’t make it up.

The enormous positive-thinking industry is no better. Barbara Ehrenreich’s book, Smile Or Die: How Positive Thinking Fooled America and the World, explains how dangerous the industry is, because, as much as guardian angels, it is based on myth and delusion. It simply doesn’t work (except for those who make fortunes by promoting it). She argues that it fosters the sort of delusion that gave us the financial crisis (and pessimistic bankers were fired for being right). Her interest in the industry started when she was diagnosed with cancer.  She says

”When I was diagnosed, what I found was constant exhortations to be positive, to be cheerful, to even embrace the disease as if it were a gift. If that’s a gift, take me off your Christmas list,”

It is quite clear that positive thinking does nothing whatsoever to prolong your life (Schofield et al 2004;   Coyne et al 2007; 2,3), any more than it will cure tuberculosis or cholera. “Encouraging patients to “be positive” only may add to the burden of having cancer while providing little benefit” (Schofield et al 2004). Far from being helpful, it can be rather cruel.

Just about every government department, the NHS, BIS, HEFCE, and NICE, has produced long reports on wellbeing and stress at work. It’s well known that income is correlated strongly with health (Marmot, M., 2004). For every tube stop you go east of Westminster you lose a year of life expectancy (London Health Observatory).  It’s been proposed that what matters is inequality of income (Wilkinson & Pickett, 2009). The nature of the evidence doesn’t allow such a firm conclusion (Lynch et al. 2004), but that isn’t really the point. The real problem is that nobody has come up with good solutions. Sadly the recommendations at the ends of all these reports don’t amount to a hill of beans. Nobody knows what to do, partly because pilot studies are rarely randomised so causality is always dubious, and partly because the obvious steps are either managerially inconvenient, ideologically unacceptable, or too expensive.

Take two examples:

Sir Michael Marmot’s famous Whitehall study (Marmot, M., 2004)  has shown that a major correlate of illness is lack of control over one’s own fate: disempowerment. What has been done about it?

In universities it has proved useful to managers to increase centralisation and to disempower academics, precisely the opposite of what Marmot recommends.

 As long as it’s convenient to managers they are not going to change policy. Rather, they hand the job to the HR department which appoints highly paid “change managers,” who add to the stress by sending you stupid graphs that show you emerging from the slough of despond into eternal light once you realise that you really wanted to be disempowered after all. Or they send you on some silly “resilience” course. Pyschobabble from UCL’s HR department

A second example comes from debt. According to a BIS report (Mental Capital and Wellbeing), debt is an even stronger risk factor for mental disorder than low income. So what is the government’s response to that? To treble tuition fees to ensure that almost all graduates will stay in debt for most of their lifetime. And this was done despite the fact that the £9k fees will save nothing for the taxpayer: in fact they’ll cost more than the £3k fees. The rise has happened, presumably, because the ideological reasons overrode the government’s own ideas on how to make people happy.

Nothing illustrates better the futility of the wellbeing industry than the response that is reported to have been given to a reporter who posed as an applicant for a “health, safety, and wellbeing adviser” with a local council. When he asked what “wellbeing” advice would involve, a member of the council’s human resources team said: “We are not really sure yet as we have only just added that to the role. We’ll want someone to make sure that staff take breaks, go for walks — that kind of stuff.”

The latest wellbeing notion to re-emerge is the happiness survey. Jeremy Bentham advocated “the greatest happiness for the greatest number,” but neglected to say how you measure it. A YouGov poll asks, “what about your general well-being right now, on a scale from 1 to 10.” I have not the slightest idea about how to answer such a question. As always some things are good, some are bad, and anyway wellbeing relative to whom?  Writing this is fun. Trying to solve an algebraic problem is fun. Constant battling with university management in order to be able to do these things is not fun. The whole exercise smacks of the sort of intellectual arrogance that led psychologists in the 1930s to claim that they could sum up a person’s intelligence in a single number.  That claim was wrong and it did great social harm.

HEFCE has spent a large amount of money setting up “pilot studies” of wellbeing in nine universities. Only one is randomised, so there will be no evidence for causality. The design of the pilots is contracted to a private company, Robertson Cooper, which declines to give full details but it seems likely that the results will be about as useless as the notorious Durham fish oil “trials”(Goldacre, 2008).

Lastly we get to the sensible end of the spectrum: patient-centred care. Again this has turned into an industry with endless meetings and reports and very few conclusions.  Epstein & Street (2011) say

“Helping patients to be more active in consultations changes centuries of physician-dominated dialogues to those that engage patients as active participants. Training physicians to be more mindful, informative, and empathic transforms their role from one characterized by authority to one that has the goals of partnership, solidarity, empathy, and collaboration.”

That’s fine, but the question that is constantly avoided is what happens when a patient with metastatic breast cancer expresses a strong preference for Vitamin C or Gerson therapy, as  advocated by the YesToLife charity. The fact of the matter is that the relationship can’t be equal when one party, usually (but not invariably) the doctor, knows a lot more about the problem than the other.

What really matters above all to patients is getting better.  Anyone in their right mind would prefer a grumpy condescending doctor who correctly diagnoses their tumour, to an empathetic doctor who misses it. It’s fine for medical students to learn social skills but there is a real danger of so much time being spent on it that they can no longer make a correct diagnosis.  Put another way, there is confusion between caring and curing. It is curing that matters most to patients. It is this confusion that forms the basis of the bait and switch tactics (see also here) used by magic medicine advocates to gain the respectability that they crave but rarely deserve.

If, as is only too often the case, the patient can’t be cured, then certainly they should be cared for. That’s a moral obligation when medicine fails in its primary aim. There is a lot of talk about individualised care. It is a buzzword of quacks and also of the libertarian wing which says NICE is too prescriptive. It sounds great, but it helps only if the individualised treatment actually works.

Nobody knows how often medicine fails to be “patient-centred.”. Even less does anyone know whether patient-centred care can improve the actual health of patients. There is a strong tendency to do small pilot trials that are as likely to mislead as inform. One properly randomised trial (Kinmonth et al., 1998) concluded

“those committed to achieving the benefits of patient centred consulting should not lose the focus on disease management.”

Non-randomised studies may produce more optimistic conclusions (e.g. Hojat et al, 2011), but there is no way to tell if this is simply because doctors find it easy to be empathetic with patients who have better outcomes.

Obviously I’m in favour of doctors being nice to patients and to listening to their wishes. But there is a real danger that it will be seen as more important than curing. There is also a real danger that it will open the doors to all sorts of quacks who claim to provide individualised empathic treatment, but end up recommending Gerson therapy for metastatic breast cancer. The new College of Medicine, which in reality is simply a reincarnation of the late unlamented Prince’s Foundation for Integrated Health, lists as its founder Capita, the private healthcare provider that will, no doubt, be happy to back the herbalists and homeopaths in the College of Medicine, and, no doubt, to make a profit from selling their wares to the NHS.

In my own experience as a patient, there is not nearly as much of a problem with patient centred care as the industry makes out. Others have been less lucky, as shown by the mid-Staffordshire disaster (Delamothe, 2010),  That seems to have resulted from PR being given priority over patients. Perhaps all that’s needed is to save money on all the endless reports and meetings (“the best substitute for work”), ban use of PR agencies (paid lying) and to spend the money on more doctors and nurses so they can give time to people who need it.  This is a job that will be hindered considerably by the government’s proposals to sell off NHS work to private providers who will be happy to make money from junk medicine.

Reference

Wilkinson. R & Pickett, K.  2009 , The Spirit Level, ISBN 978 1 84614 039 6

A footnote on Robertson Cooper and "resilience"

I took up the offer of Robertson Cooper to do their free "resilience" assessment, the company to which HEFCE has paid an undisclosed amount of money.

The first problem arose when it asked about your job. There was no option for scientist, mathematician, university or research, so I was forced to choose "education and training". (a funny juxtaposition since training is arguably the antithesis of education). It had 195 questions. mostly as unanswerable as in the YouGov happiness survey. I particularly liked question 124 "I see little point in many of the theoretical models I come across". The theoretical models that I come across most are Markov models for the intramolecular changes in a receptor molecule when it binds a ligand (try, for example, Joint distributions of apparent open and shut times of single-ion channels and maximum likelihood fitting of mechanisms). I doubt the person who wrote the question has ever heard of a model of that sort. The answer to that question (and most of the others) would not be worth the paper they are written on.

The whole exercise struck me as the worst sort of vacuous HR psychobabble. It is worrying that HEFCE thinks it is worth spending money on it.