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This post was written for the Spectator Health section, at short notice after the release of the spider letters. The following version is almost the same as appeared there, with a few updates. Some of the later sections are self-plagiarised from earlier posts.

Picture: Getty

The age of enlightenment was a beautiful thing. People cast aside dogma and authority. They started to think for themselves. Natural science flourished. Understanding of the natural world increased. The hegemony of religion slowly declined. Eventually real universities were created and real democracy developed. The modern world was born.

People like Francis Bacon, Voltaire and Isaac Newton changed the world for the better. Well, that’s what most people think. But not Charles, Prince of Wales and Duke of Cornwall.

In 2010 he said

"I was accused once of being the enemy of the Enlightenment,” he told a conference at St James’s Palace. “I felt proud of that.” “I thought, ‘Hang on a moment’. The Enlightenment started over 200 years ago. It might be time to think again and review it and question whether it is really effective in today’s conditions."

It seems that the Prince preferred things as they were before 1650. 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, a venture that got its Royal Charter from King Charles II in1622.

I suppose that the Prince cannot be blamed for his poor education. He may have been at Trinity College Cambridge, his 2.2 degree is the current euphemism for a fail (it seems that he even failed to learn the dates of the enlightenment).

His behaviour has brought to the fore the question of the role of the monarchy.

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 real 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. The Prince of Wales has been unusually public in expressing his views. His views bear directly on government policy in many areas: medicine, architecture, agriculture and the environment. These are mostly areas that involve at least an elementary knowledge of science. But that is something that he lacks. Worse still, he seems to have no consciousness of his ignorance.

The Royal family should clearly have no influence whatsoever on government policies in a democracy. And they should be seen to have no influence. The Queen is often praised for her neutrality, but the fact is that nobody has the slightest idea what happens at the weekly meetings between the Prime Minister and the Queen. I doubt that she advises the prime minister to create a National Health Service, or to tax the rich. We shall never know that. We should do.

Almost the only light that has been thrown on the secret activities of Charles was the release, on 13 May, of 27 letters that the Prince wrote to government ministers in the Blair government between 2004 and 2005. It has take 10 years of effort by the Guardian to get hold of the letters. It was ike getting blood from a stone. When the Information Commissioner ruled that the letters should be made public, the decision was vetoed by the Conservative attorney general, Dominic Grieve. He said. of the "particularly frank" letters,

" Disclosure of the correspondence could damage The Prince of Wales’ ability to perform his duties when he becomes King."

That, of course, is precisely why the documents should be revealed.

If Charles’ ability to perform his duty as King is damaged, should his subjects be kept unaware of that fact? Of course not.

In this case, the law prevailed over the attorney general. After passing through the hands of 16 different judges, the Supreme Court eventually ruled, in March, that the government’s attempts to block release were unlawful. The government spent over £400,000 in trying, and failing, to conceal what we should know. The Freedom of Information Act (2000) is the best thing that Tony Blair did, though he, and Jack Straw, thought it was the worst. I expect they are afraid of what it might reveal about their own records. Transparency is not favoured by governments of any hue.

What do the letters say?

You can read all the letters on the Guardian web site. They give the impression of being written by a rather cranky old man with bees in his bonnet and too much time on his hands. The problem is that not all cranky old men can write directly to the prime minister, and get an answer.

Not all the letters are wrong headed. But all attempt to change government policy. They represent a direct interference in the political process by the heir to the throne. That is unacceptable in a democracy. It disqualifies him from becoming king.

Some letters verged on the bizarre.

 21 October 2004 To Elliot Morley (Minister for the Environment) I particularly hope that the illegal fishing of the Patagonian Toothfish will be high on your list of priorities because until the trade is stopped, there is little hope for the poor old albatross.

No doubt illegal fishing is a problem, but not many people would write directly to a minister about the Patagonian Toothfish.

Others I agree with. But they are still attempts to influence the policies of the elected government. This one was about the fact that supermarkets pay so little to dairy farmers for milk that sometimes it’s cheaper than bottled water.

 To Tony Blair 8 September 2004 ". . . unless United Kingdom co-operatives can grow sufficiently the processors and retailers will continue to have the farmers in an arm lock and we will continue to shoot ourselves in the foot! You did kindly say that you would look at this . . . ". Yours ever, Charles

He wrote to the minister of education to try to influence education policy.

 22 February 2005 Ruth Kelly "I understand from your predecessor, Charles Clarke, that he has spoken to you about my most recent letter of 24th November, and specifically about the impact of my Education Summer School for teachers of English and History. This Programme, which involves up to ninety state school teachers each year, has been held over the past three years in Dartington, Devon, at Dunston, in Norfolk and at Buxton, in Derbyshire. I believe that they have added fresh inspiration to the national debate about the importance of English Literature and History in schools." Despite having made substantial progress, as you may be aware I remain convinced that the correct approaches to teaching and learning need to be challenged

It’s interesting that the meeting was in Dartington. That’s near Totnes ("twinned with Narnia") and it’s a centre for the bizarre educational cult promoted by the mystic and racist, Rudolf Steiner.

Then we get a reference to one of Charles’ most bizarre beliefs, alternative medicine.

 24 February 2005 Tony Blair Dear Prime Minister,  We briefly mentioned the European Union Directive on Herbal Medicines, which is having such a deleterious effect on complementary medicine sector in this country by effectively outlawing the use of certain herbal extracts. I think we both agreed this was using a sledgehammer to crack a nut. You rightly asked me what could be done about it and I am asking the Chief Executive of my Foundation for Integrated Health to provide a more detailed briefing which I hope to be able to send shortly so that your advisers can look at it. Meanwhile, I have given Martin Hurst a note suggesting someone he could talk to who runs the Herbal Practitioner’s Association. Yours ever, Charles

In this he opposes the EU Directive on Herbal Medicines. All this directive did was to insist that there was some anecdotal evidence for the safety of things that are sold to you. It asked for no evidence at all that they work, and it allowed very misleading labels. It provided the weakest form of protection from the deluded and charlatans. It was put into effect in the UK by the Medicines and Healthcare Products Regulatory Authority (MHRA). They even allowed products that were registered under this scheme to display an impressive-looking “kite-mark”. Most people would interpret this as a government endorsement of herbal medicines.

This got a sympathetic response from Tony Blair, someone who, along with his wife, was notoriously sympathetic to magic medicine.

 30 March 2005 Response from Tony Blair Dear Prince Charles Thanks too for your contacts on herbal medicines who have been sensible and constructive. They feel that the directive itself is sound and the UK regulators excellent, but are absolutely correct in saying that the implementation as it is currently planned is crazy. We can do quite a lot here: we will delay implementation for all existing products to 2011; we will take more of the implementation upon ourselves; and I think we can sort out the problems in the technical committee – where my European experts have some very good ideas. We will be consulting with your contacts and others on the best way to do this we simply cannot have burdensome regulation here. Yours ever, Tony

Note "absolutely correct in saying that the implementation as it is currently planned is crazy. We can do quite a lot here: we will delay implementation for all existing products to 2011".

Government support for acupuncture and herbal medicine was made explicit in a letter from Health Secretary, John Reid (February 2005). He assures the prince that government is taking action to "enhance the status of the herbal medicine and acupuncture professions".

Nothing could reveal more clearly the clueless attitude of the then government to quackery. In fact, after 15 years of wrangling, the promised recognition of herbalism by statutory regulation never happened. One is reminded of the time that an equally-clueless minister, Lord (Phillip) Hunt, referred to ‘psychic surgery’ as a “profession”.

We got a preview of the Prince’s letters a month before the release when Max Hastings wrote in the Spectator

I have beside me a copy of a letter allegedly written by him some years ago to a cultural institution, asserting the conviction that ‘there is a DIVINE Source which is ultimate TRUTH… that this Truth can be expressed by means of numbers… and that, if followed correctly, these principles can be expressed with infinite variety to produce Beauty’.

You can’t get much barmier than that.

Are the letters harmless?

That has been the reaction on the BBC. I can’t agree. In one sense they so trivial that it’s amazing that the government thought it was a good use of £400,000 to conceal them. But they are all the evidence that we’ll get of the Prince’s very direct attempts to influence the political process.

The Prince of Wales is more than just a crank. He has done real harm. Here are some examples.

When the generally admirable NHS Choices re-wrote their advice on homeopathy (the medicines that contain no medicine) the new advice took two years to appear. It was held up in the Department of Health while consultations were made with the Prince’s Foundation for Integrated Health. That’s Charles’ lobby organisation for crackpot medicine. (The word "integrated" is the euphemism for alternative medicine that’s in favour with its advocates.) If it were not for the fact that I used the Freedom of Information Act to find out what was going on, the public would have been given bad advice as a direct result of the Prince’s political interference.

The Prince’s Foundation for Integrated Health (FIH) folded in 2010 as a result of a financial scandal, but it was quickly reincarnated as the "College of Medicine". It was originally going to be named the College of Integrated Medicine, but it was soon decided that this sounded too much like quackery, so it was given the deceptive name, College of Medicine. It appears to be financed by well-known outsourcing company Capita. It’s closely connected with Dr Michael Dixon, who was medical advisor to the FIH, and who tried to derail the advice given by NHS Choices.

Perhaps the worst example of interference by the Prince of Wales, was his attempt to get an academic fired. Prof Edzard Ernst is the UK’s foremost expert on alternative medicine. He has examined with meticulous care the evidence for many sorts of alternative medicine.Unfortunately for its advocates, it turned out that there is very little evidence that any of it works. This attention to evidence annoyed the Prince, and a letter was sent from Clarence House to Ernst’s boss, the vice-chancellor of the University of Exeter, Steve Smith. Shamefully, Smith didn’t tell the prince to mind his ow business, but instead subjected Ernst to disciplinary proceedings, After subjecting him to a year of misery, he was let off with a condescending warning letter, but Ernst was forced to retire early. In 2011and the vice-chancellor was rewarded with a knighthood. His university has lost an honest scientist but continues to employ quacks.

Not just interfering but costing taxpayers’ money

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 Patients’ Guide (I produced a better version for nothing). And he was paid an astonishing £900,000 by DH to prepare the ground for the setting up of the hapless self-regulator, the Complementary and Natural Healthcare Council (CNHC, also known as Ofquack).

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.

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 he 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 royal warrant for a firm that sells "meningitis vaccine" that contains nothing

Ainsworth’s homeopathic pharmacy is endorsed by both Prince Charles and the Queen: it has two Royal Warrants, one from each of them.  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 who 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 was commented, justly, that

"Children will be harmed by this inaction. Children will die. And the fault must lie with Professor Sir Kent Woods, chairman of the regulator "

But the regulator has to fight the political influence of the Queen and Prince Charles. They lost.

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.

The Prince’s petulant outbursts not only endanger patients. They endanger the monarchy itself.  Whether that matters depends on 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. It would help if they refrained from using their influence on matters that are beyond their intellectual grasp..

If I wanted to know the winner of the 2.30 at Ascot, I’d ask a royal. For any other question I’d ask someone with more education.

Follow-up

The Times had a front page story "Revealed: how Charles got Blair to alter health policy" [pdf]

The British Medical Journal wrote "Prince Charles delayed regulation of herbal medicines" [pdf]

For me, the most shocking item was an interview given by Jack Straw, on Radio 4’s Today Programme. He was Home Secretary from 1997 to 2001 and Foreign Secretary from 2001 to 2006 under Tony Blair. From 2007 to 2010 he was Lord Chancellor. His response to the letters sounded like that of a right-wing conservative.

Like Blair. he deplored the Freedom of Information Act that his own government passed. He defended the secrecy, and supported the Conservative attorney-general’s attempt to veto the release of the letters. Perhaps his defence of secrecy is not surprising, He has a lot to hide, His involvement in the mendacity that led to the Iraq war, the dodgy dossier, his role in covering up torture (the "rendition" scandal). And He was suspended by the Labour party in February 2015 due to allegation of cash bribes.

He is certainly a man with plenty of things to hide.

Listen to the interview, with John Humphrys

This discussion seemed to be of sufficient general interest that we submitted is as a feature to eLife, because this journal is one of the best steps into the future of scientific publishing. Sadly the features editor thought that " too much of the article is taken up with detailed criticisms of research papers from NEJM and Science that appeared in the altmetrics top 100 for 2013; while many of these criticisms seems valid, the Features section of eLife is not the venue where they should be published". That’s pretty typical of what most journals would say. It is that sort of attitude that stifles criticism, and that is part of the problem. We should be encouraging post-publication peer review, not suppressing it. Luckily, thanks to the web, we are now much less constrained by journal editors than we used to be.

Here it is.

Scientists don’t count: why you should ignore altmetrics and other bibliometric nightmares

David Colquhoun1 and Andrew Plested2

1 University College London, Gower Street, London WC1E 6BT

2 Leibniz-Institut für Molekulare Pharmakologie (FMP) & Cluster of Excellence NeuroCure, Charité Universitätsmedizin,Timoféeff-Ressowsky-Haus, Robert-Rössle-Str. 10, 13125 Berlin Germany.

Jeffrey Beall is librarian at Auraria Library, University of Colorado Denver.  Although not a scientist himself, he, more than anyone, has done science a great service by listing the predatory journals that have sprung up in the wake of pressure for open access.  In August 2012 he published “Article-Level Metrics: An Ill-Conceived and Meretricious Idea.  At first reading that criticism seemed a bit strong.  On mature consideration, it understates the potential that bibliometrics, altmetrics especially, have to undermine both science and scientists.

Altmetrics is the latest buzzword in the vocabulary of bibliometricians.  It attempts to measure the “impact” of a piece of research by counting the number of times that it’s mentioned in tweets, Facebook pages, blogs, YouTube and news media.  That sounds childish, and it is. Twitter is an excellent tool for journalism. It’s good for debunking bad science, and for spreading links, but too brief for serious discussions.  It’s rarely useful for real science.

Surveys suggest that the great majority of scientists do not use twitter (7 — 13%).  Scientific works get tweeted about mostly because they have titles that contain buzzwords, not because they represent great science.

What and who is Altmetrics for?

The aims of altmetrics are ambiguous to the point of dishonesty; they depend on whether the salesperson is talking to a scientist or to a potential buyer of their wares.

At a meeting in London , an employee of altmetric.com said “we measure online attention surrounding journal articles” “we are not measuring quality …” “this whole altmetrics data service was born as a service for publishers”, “it doesn’t matter if you got 1000 tweets . . .all you need is one blog post that indicates that someone got some value from that paper”.

These ideas sound fairly harmless, but in stark contrast, Jason Priem (an author of the altmetrics manifesto) said one advantage of altmetrics is that it’s fast “Speed: months or weeks, not years: faster evaluations for tenure/hiring”.  Although conceivably useful for disseminating preliminary results, such speed isn’t important for serious science (the kind that ought to be considered for tenure) which operates on the timescale of years. Priem also says “researchers must ask if altmetrics really reflect impact” .  Even he doesn’t know, yet altmetrics services are being sold to universities, before any evaluation of their usefulness has been done, and universities are buying them.  The idea that altmetrics scores could be used for hiring is nothing short of terrifying.

The problem with bibliometrics

The mistake made by all bibliometricians is that they fail to consider the content of papers, because they have no desire to understand research. Bibliometrics are for people who aren’t prepared to take the time (or lack the mental capacity) to evaluate research by reading about it, or in the case of software or databases, by using them.   The use of surrogate outcomes in clinical trials is rightly condemned.  Bibliometrics are all about surrogate outcomes.

If instead we consider the work described in particular papers that most people agree to be important (or that everyone agrees to be bad), it’s immediately obvious that no publication metrics can measure quality.  There are some examples in How to get good science (Colquhoun, 2007).  It is shown there that at least one Nobel prize winner failed dismally to fulfil arbitrary biblometric productivity criteria of the sort imposed in some universities (another example is in Is Queen Mary University of London trying to commit scientific suicide?).

Schekman (2013) has said that science

“is disfigured by inappropriate incentives. The prevailing structures of personal reputation and career advancement mean the biggest rewards often follow the flashiest work, not the best.”

Bibliometrics reinforce those inappropriate incentives.  A few examples will show that altmetrics are one of the silliest metrics so far proposed.

The altmetrics top 100 for 2103

The superficiality of altmetrics is demonstrated beautifully by the list of the 100 papers with the highest altmetric scores in 2013    For a start, 58 of the 100 were behind paywalls, and so unlikely to have been read except (perhaps) by academics.

The second most popular paper (with the enormous altmetric score of 2230) was published in the New England Journal of Medicine.  The title was Primary Prevention of Cardiovascular Disease with a Mediterranean Diet.  It was promoted (inaccurately) by the journal with the following tweet:

Many of the 2092 tweets related to this article simply gave the title, but inevitably the theme appealed to diet faddists, with plenty of tweets like the following:

The interpretations of the paper promoted by these tweets were mostly desperately inaccurate. Diet studies are anyway notoriously unreliable. As John Ioannidis has said

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

This sad situation comes about partly because most of the data comes from non-randomised cohort studies that tell you nothing about causality, and also because the effects of diet on health seem to be quite small.

The study in question was a randomized controlled trial, so it should be free of the problems of cohort studies.  But very few tweeters showed any sign of having read the paper.  When you read it you find that the story isn’t so simple.  Many of the problems are pointed out in the online comments that follow the paper. Post-publication peer review really can work, but you have to read the paper.  The conclusions are pretty conclusively demolished in the comments, such as:

“I’m surrounded by olive groves here in Australia and love the hand-pressed EVOO [extra virgin olive oil], which I can buy at a local produce market BUT this study shows that I won’t live a minute longer, and it won’t prevent a heart attack.”

We found no tweets that mentioned the finding from the paper that the diets had no detectable effect on myocardial infarction, death from cardiovascular causes, or death from any cause.  The only difference was in the number of people who had strokes, and that showed a very unimpressive P = 0.04.

Neither did we see any tweets that mentioned the truly impressive list of conflicts of interest of the authors, which ran to an astonishing 419 words.

“Dr. Estruch reports serving on the board of and receiving lecture fees from the Research Foundation on Wine and Nutrition (FIVIN); serving on the boards of the Beer and Health Foundation and the European Foundation for Alcohol Research (ERAB); receiving lecture fees from Cerveceros de España and Sanofi-Aventis; and receiving grant support through his institution from Novartis. Dr. Ros reports serving on the board of and receiving travel support, as well as grant support through his institution, from the California Walnut Commission; serving on the board of the Flora Foundation (Unilever). . . “

And so on, for another 328 words.

The interesting question is how such a paper came to be published in the hugely prestigious New England Journal of Medicine.  That it happened is yet another reason to distrust impact factors.  It seems to be another sign that glamour journals are more concerned with trendiness than quality.

One sign of that is the fact that the journal’s own tweet misrepresented the work. The irresponsible spin in this initial tweet from the journal started the ball rolling, and after this point, the content of the paper itself became irrelevant. The altmetrics score is utterly disconnected from the science reported in the paper: it more closely reflects wishful thinking and confirmation bias.

The fourth paper in the altmetrics top 100 is an equally instructive example.

 This work was also published in a glamour journal, Science. The paper claimed that a function of sleep was to “clear metabolic waste from the brain”.  It was initially promoted (inaccurately) on Twitter by the publisher of Science.  After that, the paper was retweeted many times, presumably because everybody sleeps, and perhaps because the title hinted at the trendy, but fraudulent, idea of “detox”.  Many tweets were variants of “The garbage truck that clears metabolic waste from the brain works best when you’re asleep”.

But this paper was hidden behind Science’s paywall.  It’s bordering on irresponsible for journals to promote on social media papers that can’t be read freely.  It’s unlikely that anyone outside academia had read it, and therefore few of the tweeters had any idea of the actual content, or the way the research was done.  Nevertheless it got “1,479 tweets from 1,355 accounts with an upper bound of 1,110,974 combined followers”.  It had the huge Altmetrics score of 1848, the highest altmetric score in October 2013.

Within a couple of days, the story fell out of the news cycle.  It was not a bad paper, but neither was it a huge breakthrough.  It didn’t show that naturally-produced metabolites were cleared more quickly, just that injected substances were cleared faster when the mice were asleep or anaesthetised.  This finding might or might not have physiological consequences for mice.

Worse, the paper also claimed that “Administration of adrenergic antagonists induced an increase in CSF tracer influx, resulting in rates of CSF tracer influx that were more comparable with influx observed during sleep or anesthesia than in the awake state”.  Simply put, giving the sleeping mice a drug could reduce the clearance to wakeful levels.  But nobody seemed to notice the absurd concentrations of antagonists that were used in these experiments: “adrenergic receptor antagonists (prazosin, atipamezole, and propranolol, each 2 mM) were then slowly infused via the cisterna magna cannula for 15 min”.  Use of such high concentrations is asking for non-specific effects.  The binding constant (concentration to occupy half the receptors) for prazosin is less than 1 nM,  so infusing 2 mM is working at a million times greater than the concentration that should be effective. That’s asking for non-specific effects.  Most drugs at this sort of concentration have local anaesthetic effects, so perhaps it isn’t surprising that the effects resembled those of ketamine.

The altmetrics editor hadn’t noticed the problems and none of them featured in the online buzz.  That’s partly because to find it out you had to read the paper (the antagonist concentrations were hidden in the legend of Figure 4), and partly because you needed to know the binding constant for prazosin to see this warning sign.

The lesson, as usual, is that if you want to know about the quality of a paper, you have to read it. Commenting on a paper without knowing anything of its content is liable to make you look like an jackass.

A tale of two papers

Another approach that looks at individual papers is to compare some of one’s own papers.  Sadly, UCL shows altmetric scores on each of your own papers.  Mostly they are question marks, because nothing published before 2011 is scored.  But two recent papers make an interesting contrast.  One is from DC’s side interest in quackery, one was real science.  The former has an altmetric score of 169, the latter has an altmetric score of 2.

 The first paper was “Acupuncture is a theatrical placebo”, which was published as an invited editorial in Anesthesia and Analgesia [download pdf].  The paper was scientifically trivial. It took perhaps a week to write.  Nevertheless, it got promoted it on twitter, because anything to do with alternative medicine is interesting to the public.  It got quite a lot of retweets.  And the resulting altmetric score of 169 put it in the top 1% of all articles altmetric have tracked, and the second highest ever for Anesthesia and Analgesia.  As well as the journal’s own website, the article was also posted on the DCScience.net blog (May 30, 2013) where it soon became the most viewed page ever (24,468 views as of 23 November 2013), something that altmetrics does not seem to take into account.

Compare this with the fate of some real, but rather technical, science.

 My [DC] best scientific papers are too old (i.e. before 2011) to have an altmetrics score, but my best score for any scientific paper is 2.  This score was for Colquhoun & Lape (2012) “Allosteric coupling in ligand-gated ion channels”.  It was a commentary with some original material.   The altmetric score was based on two tweets and 15 readers on Mendeley.  The two tweets consisted of one from me (“Real science; The meaning of allosteric conformation changes http://t.co/zZeNtLdU ”). The only other tweet as abusive one from a cyberstalker who was upset at having been refused a job years ago.  Incredibly, this modest achievement got it rated “Good compared to other articles of the same age (71st percentile)”.

Bibliometricians spend much time correlating one surrogate outcome with another, from which they learn little.  What they don’t do is take the time to examine individual papers.  Doing that makes it obvious that most metrics, and especially altmetrics, are indeed an ill-conceived and meretricious idea. Universities should know better than to subscribe to them.

Although altmetrics may be the silliest bibliometric idea yet, much this criticism applies equally to all such metrics.  Even the most plausible metric, counting citations, is easily shown to be nonsense by simply considering individual papers.  All you have to do is choose some papers that are universally agreed to be good, and some that are bad, and see how metrics fail to distinguish between them.  This is something that bibliometricians fail to do (perhaps because they don’t know enough science to tell which is which).  Some examples are given by Colquhoun (2007) (more complete version at dcscience.net).

Eugene Garfield, who started the metrics mania with the journal impact factor (JIF), was clear that it was not suitable as a measure of the worth of individuals.  He has been ignored and the JIF has come to dominate the lives of researchers, despite decades of evidence of the harm it does (e.g.Seglen (1997) and Colquhoun (2003) )  In the wake of JIF, young, bright people have been encouraged to develop yet more spurious metrics (of which ‘altmetrics’ is the latest).  It doesn’t matter much whether these metrics are based on nonsense (like counting hashtags) or rely on counting links or comments on a journal website.  They won’t (and can’t) indicate what is important about a piece of research- its quality.

People say – I can’t be a polymath. Well, then don’t try to be. You don’t have to have an opinion on things that you don’t understand. The number of people who really do have to have an overview, of the kind that altmetrics might purport to give, those who have to make funding decisions about work that they are not intimately familiar with, is quite small.  Chances are, you are not one of them. We review plenty of papers and grants.  But it’s not credible to accept assignments outside of your field, and then rely on metrics to assess the quality of the scientific work or the proposal.

It’s perfectly reasonable to give credit for all forms of research outputs, not only papers.   That doesn’t need metrics. It’s nonsense to suggest that altmetrics are needed because research outputs are not already valued in grant and job applications.  If you write a grant for almost any agency, you can put your CV. If you have a non-publication based output, you can always include it. Metrics are not needed. If you write software, get the numbers of downloads. Software normally garners citations anyway if it’s of any use to the greater community.

When AP recently wrote a criticism of Heather Piwowar’s altmetrics note in Nature, one correspondent wrote: "I haven’t read the piece [by HP] but I’m sure you are mischaracterising it". This attitude summarizes the too-long-didn’t-read (TLDR) culture that is increasingly becoming accepted amongst scientists, and which the comparisons above show is a central component of altmetrics.

Altmetrics are numbers generated by people who don’t understand research, for people who don’t understand research. People who read papers and understand research just don’t need them and should shun them.

But all bibliometrics give cause for concern, beyond their lack of utility. They do active harm to science.  They encourage “gaming” (a euphemism for cheating).  They encourage short-term eye-catching research of questionable quality and reproducibility. They encourage guest authorships: that is, they encourage people to claim credit for work which isn’t theirs.  At worst, they encourage fraud.

No doubt metrics have played some part in the crisis of irreproducibility that has engulfed some fields, particularly experimental psychology, genomics and cancer research.  Underpowered studies with a high false-positive rate may get you promoted, but tend to mislead both other scientists and the public (who in general pay for the work). The waste of public money that must result from following up badly done work that can’t be reproduced but that was published for the sake of “getting something out” has not been quantified, but must be considered to the detriment of bibliometrics, and sadly overcomes any advantages from rapid dissemination.  Yet universities continue to pay publishers to provide these measures, which do nothing but harm.  And the general public has noticed.

It’s now eight years since the New York Times brought to the attention of the public that some scientists engage in puffery, cheating and even fraud.

Overblown press releases written by journals, with connivance of university PR wonks and with the connivance of the authors, sometimes go viral on social media (and so score well on altmetrics).  Yet another example, from Journal of the American Medical Association involved an overblown press release from the Journal about a trial that allegedly showed a benefit of high doses of Vitamin E for Alzheimer’s disease.

This sort of puffery harms patients and harms science itself.

We can’t go on like this.

What should be done?

Post publication peer review is now happening, in comments on published papers and through sites like PubPeer, where it is already clear that anonymous peer review can work really well. New journals like eLife have open comments after each paper, though authors do not seem to have yet got into the habit of using them constructively. They will.

It’s very obvious that too many papers are being published, and that anything, however bad, can be published in a journal that claims to be peer reviewed .  To a large extent this is just another example of the harm done to science by metrics  –the publish or perish culture.

Attempts to regulate science by setting “productivity targets” is doomed to do as much harm to science as it has in the National Health Service in the UK.    This has been known to economists for a long time, under the name of Goodhart’s law.

Here are some ideas about how we could restore the confidence of both scientists and of the public in the integrity of published work.

• Nature, Science, and other vanity journals should become news magazines only. Their glamour value distorts science and encourages dishonesty.
• Print journals are overpriced and outdated. They are no longer needed.  Publishing on the web is cheap, and it allows open access and post-publication peer review.  Every paper should be followed by an open comments section, with anonymity allowed.  The old publishers should go the same way as the handloom weavers. Their time has passed.
• Web publication allows proper explanation of methods, without the page, word and figure limits that distort papers in vanity journals.  This would also make it very easy to publish negative work, thus reducing publication bias, a major problem (not least for clinical trials)
• Publish or perish has proved counterproductive. It seems just as likely that better science will result without any performance management at all. All that’s needed is peer review of grant applications.
• Providing more small grants rather than fewer big ones should help to reduce the pressure to publish which distorts the literature. The ‘celebrity scientist’, running a huge group funded by giant grants has not worked well. It’s led to poor mentoring, and, at worst, fraud.  Of course huge groups sometimes produce good work, but too often at the price of exploitation of junior scientists
• There is a good case for limiting the number of original papers that an individual can publish per year, and/or total funding. Fewer but more complete and considered papers would benefit everyone, and counteract the flood of literature that has led to superficiality.
• Everyone should read, learn and inwardly digest Peter Lawrence’s The Mismeasurement of Science.

A focus on speed and brevity (cited as major advantages of altmetrics) will help no-one in the end. And a focus on creating and curating new metrics will simply skew science in yet another unsatisfactory way, and rob scientists of the time they need to do their real job: generate new knowledge.

It has been said

“Creation is sloppy; discovery is messy; exploration is dangerous. What’s a manager to do?
The answer in general is to encourage curiosity and accept failure. Lots of failure.”

And, one might add, forget metrics. All of them.

Follow-up

17 Jan 2014

This piece was noticed by the Economist. Their ‘Writing worth reading‘ section said

"Why you should ignore altmetrics (David Colquhoun) Altmetrics attempt to rank scientific papers by their popularity on social media. David Colquohoun [sic] argues that they are “for people who aren’t prepared to take the time (or lack the mental capacity) to evaluate research by reading about it.”"

20 January 2014.

Jason Priem, of ImpactStory, has responded to this article on his own blog. In Altmetrics: A Bibliographic Nightmare? he seems to back off a lot from his earlier claim (cited above) that altmetrics are useful for making decisions about hiring or tenure. Our response is on his blog.

20 January 2014.

Jason Priem, of ImpactStory, has responded to this article on his own blog, In Altmetrics: A bibliographic Nightmare? he seems to back off a lot from his earlier claim (cited above) that altmetrics are useful for making decisions about hiring or tenure. Our response is on his blog.

23 January 2014

The Scholarly Kitchen blog carried another paean to metrics, A vigorous discussion followed. The general line that I’ve followed in this discussion, and those mentioned below, is that bibliometricians won’t qualify as scientists until they test their methods, i.e. show that they predict something useful. In order to do that, they’ll have to consider individual papers (as we do above). At present, articles by bibliometricians consist largely of hubris, with little emphasis on the potential to cause corruption. They remind me of articles by homeopaths: their aim is to sell a product (sometimes for cash, but mainly to promote the authors’ usefulness).

It’s noticeable that all of the pro-metrics articles cited here have been written by bibliometricians. None have been written by scientists.

28 January 2014.

Dalmeet Singh Chawla,a bibliometrician from Imperial College London, wrote a blog on the topic. (Imperial, at least in its Medicine department, is notorious for abuse of metrics.)

29 January 2014 Arran Frood wrote a sensible article about the metrics row in Euroscientist.

2 February 2014 Paul Groth (a co-author of the Altmetrics Manifesto) posted more hubristic stuff about altmetrics on Slideshare. A vigorous discussion followed.

5 May 2014. Another vigorous discussion on ImpactStory blog, this time with Stacy Konkiel. She’s another non-scientist trying to tell scientists what to do. The evidence that she produced for the usefulness of altmetrics seemed pathetic to me.

7 May 2014 A much-shortened version of this post appeared in the British Medical Journal (BMJ blogs)

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

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

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

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

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

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

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

As I said at the time

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

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

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

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

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

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

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

The criteria for accreditation state

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

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

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

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

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

It is very clear that the CNHC fails standard 6.

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

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

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

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

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

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

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

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

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

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

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

The current Skills for Health entry for reflexology says

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

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

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

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

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

The training problem.

The PSA’s criteria for accreditation say

Standard 9: education and training

The organisation:

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

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

and later

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

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

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

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

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

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

What’s wrong with regulators?

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

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

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

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

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

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

What can be done?

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

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

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

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

But they don’t, and it isn’t.

Follow-up

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Follow-up

30 August 2013

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

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

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

The 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".

The absurdness of allowing statutory regulation of herbal medicines, both Western and Chinese has already been pointed out here, in Government lends credibility to quacks and charlatans, and by Andrew Lewis in  “How to Spot Bad Regulation of Alternative Medicine

The harm done by the government’s endorsement of herbal products could be ameliorated if they were labelled honestly. The labelling is a matter for the Medicines and Healthcare products Regulatory Authority (MHRA), and for a while I have been writing to the head of the MRH, Kent Woods, and to Richard Woodfield (head of MHRA herbal medicine policy), in an attempt to work out their reasons for not telling the consumer the simple truth.

A similar (but even worse) problem arises in the labels that have been allowed by the MHRA for homeopathic pills. That has been discussed in Pseudo-regulation: another chance to save the MHRA from looking idiotic . The matter is not yet decided, but on past performance, I’m pessimistic about whether the MHRA will listen to scientists.

The Traditional Herbal Registration (THR) scheme allows herbal medicines that are registered on this scheme to be sold if they are safe, and have been in use for 30 years. There is need to supply any information whatsoever about whether they work or not. That itself is very odd, given that the MHRA’s strap line says

"We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe."

In the case of herbals, the bit about ensuring that medicines work has been brushed under the carpet.

A typical dishonest label

Take "Echina Cold Relief". The Traditional Herbal Regulation document specifies the label.

Note, first of all, the therapeutic claim in the brand name itself. This is blatant practice for most herbals and appears to be unregulated. The label says

 It is my contention that most people would interpret this label as a claim that the tablets would have a beneficial effect on the symptoms of "common cold and influenza type infections". The impression is reinforced by the government stamp of approval on the package. The MHRA tell me that no tests have been done to discover how shoppers interpret these words. They should have been done.

Why is there nothing on the label that tells the plain, unvarnished truth? Perhaps something like this

"There is no evidence that this product works for the indications mentioned".

Or

"Clinical trials have shown this product to be ineffective for xxx "

or, at a minimum

"The MHRA kite mark does not imply that this product is effective"

Some Evidence

Echinacea is a generous choice of example because, unlike most herbs, there is a bit of evidence about its effectiveness. A Cochrane review says

Sixteen trials including a total of 22 comparisons of Echinacea preparations and a control group (19 placebo, 2 no treatment, 1 another herbal preparation) met the inclusion criteria. All trials except one were double-blinded. The majority had reasonable to good methodological quality. Three comparisons investigated prevention; 19 comparisons investigated treatment of colds. A variety of different Echinacea preparations were used. None of the prevention trials showed an effect over placebo. Comparing an Echinacea preparation with placebo as treatment, a significant effect was reported in nine comparisons, a trend in one, and no difference in six. Evidence from more than one trial was available only for preparations based on the aerial parts of Echinacea purpurea (E. purpurea).

“It seems that some preparations based on the herb of Echinacea purpurea might be effective for this purpose in adults, while there is no clear evidence that other preparations are effective or that children benefit. Side effects were infrequent but rashes were reported in one trial in children.”

The US agency NCCAM has spent over a billion dollars on testing various sorts of alternative treatment, and has failed to find a single useful treatment, They say

"Two NCCAM-funded studies did not find a benefit from echinacea, either as Echinacea purpurea fresh-pressed juice for treating colds in children, or as an unrefined mixture of Echinacea angustifolia root and Echinacea purpurea root and herb in adults."

So the evidence is a mess. There is no evidence that Echinacea can prevent colds, and, at the very best, it might shorten slightly the time for which cold symptoms last. The most likely interpretation of the mixture of contradictory results, many negative trials with a handful of small positive effects, is that for practical purposes, echinacea is useless. There is NO treatment known that affects the duration of a cold to any useful extent.

I wrote to Kent Woods in February 2011

 Hello Sorry to bother you again, but recent events have caused me to think about a rather fundamental question, and I have never seen it discussed in any official documents.  I suspect it needs to be answered at the highest level. Question,  Do you make any distinction between (a) herbs that have unknown efficacy (most of them). and (b) herbs that have been shown in good trials to have no useful effect (like echinacea)? It is one thing to say “traditionally used for …” when you don’t know whether it is true or not. It is quite another thing to say “traditionally used for. . . ” when you know it is untrue No such distinction seems to be made at the moment. Is that because the distinction has never been considered by the MHRA? Or is it because it has been considered, but dismissed as unimportant? Or is it considered important but you are prevented from doing anything about it (and, if this is the case, what prevents you?) Best wishes David

His reply was, essentially, that herbs come in so many different forms that they can’t all be tested so it is never possible to say that a herb “does not work to any useful extent”

 . . . Based on our experience of regulating herbal medicines, we think it unlikely for the foreseeable future that there would be available for particular herbs a comprehensive body of published studies that meet medicines regulatory standards and cover systematically the numerous possible permutations as to type of extract, plant species and part of plant. Consequently, it is unlikely that evidence would be available for MHRA to know that a traditional herbal product did not have efficacy. In summary, you suggest an interesting scenario the handling of which would be worthy of further consideration in the event of major advances in the range and quality of clinical trials of herbal medicines – but for the foreseeable future we would see the dilemma as largely a theoretical one. Regards Kent Woods

This strikes me as a cop-out. It amounts to saying that it’s impossible ever to say that a treatment us useless. If NICE took the same view, no medicine would ever be ruled out as having no useful effect.

Then I asked about a press release from the MHRA, dated 18 March 2011.

 Hello I really must object to the wording of today’s press release http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON111687 It says (my emphasis) "The growth of the THR scheme means that consumers will have access to a wide choice of over-the-counter herbal medicines made to assured standards. "The current signs are that the market will be lively and competitive. The key difference for consumers is that in future they will be in the driving seat and able to make an informed choice when they wish to use these medicines. " Since the main sort of information that people want about a medicine is whether it works, and you have explicitly ruled out any information about that, the description "informed choice" seems to me to be exaggerated to the point of dishonesty. This raises another question.  Many people think that the wording that you approve is deceptive.  can you tell me whether you have yet done tests to discover whether or not the average consumer interprets your wording as suggesting effectiveness?  This was raised (apropos oh homeopathics) with Kent Woods at the SciTech enquiry and they were assured such tests had been done.  Still nobody has seen the result of such tests.  Please will you let me know if they have been done, and, if they have, what the results were?  if they have not been done, why not? Best regards David Colquhoun

The legal requirement

In response to my letter, Richard Woodfield said

"Specifically on the question of wording affecting efficacy, we have to comply with the requirements of the herbals Directive which specifies the required product information about the traditional basis of the registration. We have not user tested the required statement in the Directive.
"

The European Herbals directive 2004/24/EC [download it] does make it mandatory to include the words used by the MHRA

“In addition to the requirements of Articles 86 to 99, any advertisement for a medicinal product registered under this chapter shall contain the following statement: Traditional herbal medicinal product for use in specified indication( s) exclusively based upon long-standing use.”

Telling the truth on the label

I asked the MHRA whether there was any legal reason why they could not add the following notice to the wording required by the European Directive. I had to ask the question several times before I got a straight answer, but the answer eventually turned out to be that there is no legal reason that bars honest labels. Eventually Richard Woodfield told me there was no legal reason.

 Dear Prof Colquhoun There is no specific bar in the European Directive that would definitely preclude requiring additional statements that were consistent with the Directive. Obviously one would have to look at the specifics of what was proposed. The main bar is that of Government policy.  Under the previous Administration when the scheme was set up there was a strong policy of avoiding gold plating of European legislation – and this would clearly be a case of gold plating.  Under the new Government that policy of avoiding gold plating has been strengthened further.  And added to that there is now a presumption that wherever possible Directives should be transposed by “copy out” of the text rather than elaborating upon the requirements of the Directive. The onus would be on those seeking gold plating to demonstrate that it was necessary.  In the present absence of evidence of significant detriment under the THR scheme to consumers who for example choose to take a THR to help with a condition such as mild indigestion we have no present plans to propose the introduction of a form of retrospective gold plating of this legislation. As recognised in your last email, I think that is about as far as we can usefully comment on the issue for the time being. Regards Richard Woodfield

So, at last we have the answer. And pretty pathetic it is. “Gold-plating” is a term that is used by the anti-European lobby to describe the process of not simply implementing European law but making it more strict that is essential. In this case, I would claim that making the label honest was the opposite of gold-plating, The European law is obviously designed to encourage the herbal industry by disguising the lack of evidence for the herbs. The MHRA should correct that deficiency but has declined to do so.

Safety

The herbal medicine business, especially the Chinese Traditional medicine, is riddled with impure, contaminated and sometimes lethally toxic rubbish. Of course it is right that the public should be protected from this. Probably it is a job that should be done by Trading Standards officers, but sadly they have shown themselves time and time again to be incompetent and unwilling to enforce the law when it comes to false health claims. The MHRA make a reasonably good job on this front, but that is no reason for them to endorse misleading labels. Statutory regulation by the HPC will do nothing to help: on the contrary it will endorse courses that teach dangerous nonsense.

The MHRA’s Herbal Medicines Advisory Committee should have resisted this misleading labelling, but they do not seem to have not done so (it’s hard to tell because the published minutes are totally free of any useful information). The chairman of that committee is Professor Philip A Routledge OBE MB BS MD FRCP FRCPE. If I had been in his position, I would have resigned. I believe that he has let down honest science, and potentially endangered patients by not insisting on honest labels. I do hope that this was not a result of pressure from the Prince of Wales. We know he has lobbied Kent Woods and Philip Routledge. Incidentally, Routledge is president elect of the British Pharmacological Society. Quackery has crept in even there.

What can be done

There us no reason why, even now, the MHRA could not change the labels to something honest. I expect the government is pressing them to support the herbal industry, and big business usually wins over regulators (as with banks).

Freedom of choice by consumers was mentioned several times by the MHRA. That’s fine. Nobody wants to ban echinacea. The whole point of labels is to ensure that it is informed choice. Labels that mislead do not help anyone. They hurt the consumer and they are disastrous for the reputation for integrity of the MHRA.

We should keep up the pressure on the MHRA. Here are a couple of my recent efforts, on BBC Breakfast TV.

The second interview was joint with Dick Middleton. It should have been made clear that Middleton is a pharmacist who is technical director of Schwabe Pharma, a company that sells expensive herbal pills, so has a vested financial interest in disguising the lack of evidence for efficacy,

Follow-up

1 May 2011. The new herbal regulations have come into effect. Radio 5 put me up against the herbal industry representative, Michael McIntyre (chair of the European Herbal & Traditional Medicine Practitioners Association). I was pleased to get the chance to debate directly with him, because he has been misrpresenting the evidence for years. See, for example, Some truly appalling reporting of science by the BBC. and Government lends credibility to quacks and charlatans. I was able, at last, to ask him directly, which herb had the best evidence for its efficacy. He repeatedly refused to answer: “I’m not going to get into detail”. Eventually he resorted to the argument that herbalists treat people not diseases. I pointed out that the MHRA-approved labels list all sorts of diseases. No response. He then misquotes Sackett, who did NOT say that experience was as good as RCTs.

McIntyre goes on to misrepresent the BMJ Clinical Evidence paper which, he says, shows that 46% of all treatments are not proven to be effective. It is hard to be believe that McIntyre is really unaware that a large proportion of those that were not shown to be effective are CAM treatments, herbal medicine and the like. Professor John Garrow has pointed this out (see, also Healthwatch). Either he doesn’t read the literature or he deliberately misrepresents it.

Then a caller came in to swear that Chinese Medicine had cured his prostate problem and his wife’s hair. Of course he hadn’t any idea of how is prostate would have progressed if he hadn’t taken the Chinese medicine. Luckily for him, he didn’t have prostate cancer (the people who take Chinese medicine for cancer are probably dead so they can’t appear on the radio). These people are difficult to deal with without appearing rude, by saying they are gullible and deceived. I tried. Interestingly McIntyre did not leap to the defence of Chinese herbs.

The long-awaited government decision concerning statutory regulation of herbalists, traditional Chinese medicine (TCM) and acupuncture came out today.

Get the Department of Health (DH) report [pdf]

It is not good news. They have opted for statutory regulation by the Health Professions Council (HPC). This is much what was recommended by the disgraceful Pittilo report, about which I wrote a commentary in the Times (or free version here), and A very bad report: gamma minus for the vice-chancellor.

The DH report is merely an analysis of responses to the consultation, but the MHRA says

"The Health Professions Council (HPC) has now been asked to establish a statutory register for practitioners supplying unlicensed herbal medicines. The proposal is, following creation of this register, to make use of a derogation in European medicines legislation (Article 5 (1) of Directive 2001/83/EC) that allows national arrangements to permit those designated as “authorised healthcare professionals” to commission unlicensed medicines to meet the special needs of their patients."

The MHRA points out that this started 11 years ago with the publication of the  House of Lords report (2000). Both that report, and the government’s response to it, set the following priorities. Both state clearly

“… we recommend that three important questions should be addressed in the following order . .

• (1) does the treatment offer therapeutic benefits greater than placebo?
• (2) is the treatment safe?
• (3) how does it compare, in medical outcome and cost-effectiveness, with other forms of treatment?

The report of DH and the MHRA’s response have ignored totally two of these three requirements. There is no consideration whatsoever of whether treatments work better than placebo (point one) and there is no consideration whatsoever of cost-effectiveness (point 3). These two important recommendations in the Houss of Lords report have simply been brushed under the carpet.

Needless to say, herbalists are head over heels with joy at this sign of official endorsement (here is one reaction)

Here are my first reactions. The post will be updated soon.

The DH report is, in a sense, democratic. They have simply counted the responses, for and against each proposal. They seem to be quite unaware that most of the responses come from High Street herbailsts whose main aim is to gain respectability. The response of the Academy of Royal Medical Colleges counts as one vote, just the same as the owner of a Chinese medicine shop. This is not how health policy should be determined. Some intervention of the brain is needed, but that isn’t apparent in the report.

At present the HPC regulates Arts therapists, biomedical scientists, chiropodists/podiatrists, clinical scientists, dietitians, occupational therapists, operating department practitioners, orthoptists, paramedics, physiotherapists, prosthetists/orthotists, radiographers and speech & language therapists. I shudder to think what all these good people will think about being lumped together with people who practice evidence-free medicine (or, worse, forms of medicine where there is good evidence that they don’t work).

The vast majority of herbalists, traditional Chinese medicine (TCM) and acupuncture has no good evidence that it works, In the case of soem herbal medicines and acupuncture, there is good evidence that they don’t work. Yet the HPC has, as one of its criteria, that aspiring to be regulated by them requires

"practise based on evidence of efficacy"

The Department of Health seems to have quietly forgotten about this criterion. It cannot possibly be met. The HPC has already expressed its willingness to go along with this two-faced approach (see Health Professions Council ignores its own rules: the result is nonsense )

Another mistake made by the Department of Health regards the value of "training". The report (page 11) says

Would statutory regulation lessen the risk of harm? (Q2)
Again, the vast majority of respondents thought it would. Reasons given were that statutory regulation would ensure that herbal practitioners and acupuncturists are carefully and thoroughly trained. That training is subject to accreditation, evaluation and periodic review by independent educational and training professionals, and disciplinary oversight by a regulating body. Incompetent or unscrupulous practitioners could be struck off the register and prevented from practising.

Although it is pointed out to them in several responses, the Department of Health seems quite incapable of understanding a simple and obvious truth. Spending three years training people to learn things that are not true, safeguards nobody. On the contrary, it endangers the public. Training in nonsense is obviously a nonsense.

At the end of the report is a list of organisations who responded, As expected, they are predominantly trade bodies that have a vested interest in allowing thinks to be sold freely regardless of whether they work or not. The first four are Alliance of Herbal Medicine Practitioners. European herbal and Traditional Medicine Practitioners Association (ETMPA), Association Chinese Medicine Practitioners (UK) (ACMP) and Acupuncture Society. And so on.

More coming soon.

Follow-up

16 February 2011. Later the same day, we see one reason why Michael Mcintyre, chair of the European Herbal Practitioners Association, got what he wanted to promote his trade. They had evidently hired a PR Agency, Cogitamus, to push their case. Now they are crowing about their victory. And of course his profits were not harmed by the free publicity that was given to his cause by the BBC,

The pinheads in the Department of Health are more easily persuaded by a PR agency than by any number of people who know a lot more about it, and who have no profit motive.

17 February 2011.

The herbal problem was front page news in the London free paper, the Metro: Chinese medicine and herbal ban to see Britain defy EU laws

The Daily Telegraph covered the story: Herbal medicine to be regulated, says Andrew Lansley. The comments featured some pretty mad rants from herbalists, to which I tried to reply.

The Metro article elicited a fine bit of abuse from a Lynda Kane. I’m constantly amazed at the downright viciousness of cuddly holistic therapists when they get found out. I guess it is just another bad case of cognitive dissonance. I can’t resist a few quotations.

Sir,

“I have just come across your asinine comments quoted in the London Metro newspaper re the EU herbal medicine directive. For a supposed scientist your mis-informed, closed-minded, unsubstantiated bigotry leaves me speechless”

“As a scientist myself, I abide by the virtues of open-minded neutrality and accepting the hypothesis until proven otherwise by null-hypothesis based research.”

“How many of the innumerable studies on the efficacy of herbal medicine have you read? “

“Perhaps in your ‘day’ professors could say whatever they liked and be listened to. That day is long gone, as you must know from the various law-suits you have been party to.”

I love the idea that statistics allow you to accept any hypothesis whatsoever until someone shows it to be wrong.

This would be funny if it were not so sad (and rather painful). As always I replied politely and referred her to NCCAM’s Guide to Herbs, so she can check up on that plethora of evidence that she seems to think exists.

This is Lynda Kane of energyawareness.org. I can recommend her web site, if you want some truly jaw-dropping woo. She’ll sell you a “White Jade Energy Egg – may provide up to 5 times as much protection from wifi and from other peoples’ energies – costs £47.00”. Hmm, sounds good. How does it work? Easy.

“The human energy or “qi” field is shaped like an egg. It is being attacked by many forms of natural and man-made environmental stress 24 hours a day.”

I guess that’s OK according to Ms Kane’s interpretation of statistics which allows you to accept any hypothesis whatsoever until someone shows it to be wrong.

Anyone for Trading Standards or the ASA?

17 February 2011. The excellent Andy Lewis has posted on similar problems “How to Spot Bad Regulation of Alternative Medicine

.20 July 2013

Nothing visible happened after this announcement. Until the government’s resident medical loon, David Tredinnick MP forced a debate on the matter. His introduction to the debate was his usual make-believe. Sadly it made much of an exhibit at the Royal Society Summer Science exhibition -a bit of bait and swich by aromatherapists.

After ploughing your way through pages of nonsense, you get to the interesting bit. At 10.38 am, The Parliamentary Under-Secretary of State for Health, Dr Daniel Poulter, announced what was happening. It seems that there may, after all, have been some effect of all the sensible submissions which pointed out the impossibility of regulating nonsense. The question of regulation has, yet again, been postponed.

"To ensure that we take forward the matter effectively, we want to bring together experts and interested parties from all sides of the debate to form a working group that will gather evidence and consider all the viable options in more detail,"

One wonders who will be on this working group? If they don’t choose the right people, it could be as bad as the Pittilo report. It wasn’t reassuring to read

" we want to set up a working group and to work with my hon. Friend [Tredinnick], and herbalists and others, to ensure that the legislation is fit for purpose."

I hate to be forced to return to the world’s most boring delusion, homeopathy. It is boring because the battle to inform people how daft it is has been almost won. Now not a single Bachelors degree in homeopathy appears in UCAS, compared with at least five in 2007. But the battle is not quite won with the UK Government. This post is not so much about homeopathy as about the failures of the Government and the MHRA.

The Medicines and Health Regulatory Authority (MHRA), has just launched yet another consultation and I have felt obliged to waste an entire Sunday writing a response to it, I can’t imagine that any scientist would disagree much with what I have written, but most of them have far better ways to spend their time than bothering about the lunatic fringes of medicine. No doubt most of the responses will come from people who make money from homeopathy, Not just the homeopaths on the High Street, but also the very rich companies like Boiron and Weleda who make enormous profits from selling pills that contain nothing but a bit of sugar.

The documents

The consultation concerns what should be done, about homeopathy in the wake of the scarifying report of the House of Commons Select Committee [get pdf], and the governments response to that report [get pdf].

The MHRA’s request for consultation is here. Download the consultation document. You can download my full response [get pdf], Please write your own response and send it to andreafarmer@mhra.gsi.gov.uk before February 17th. Feel free to plagiarise anything you find here.

Now I’ll filll in some of the background and outline why I think the MHRA still hasn’t understood.

The Medicines Act 1968 and PLRs

The Medicines Act (1968) was passed in the wake of the thalidomide disaster. It required evidence that medicines work and that they are safe. It was not possible to check all existing medicines by the time the Act was implemented in 1971, so, as a temporary measure, many medicines, including homeopathic stuff, were give a "public licence of right" (PLR). Forty years later they have mostly vanished. But not for homeopathy. The PLR is the licence that allows homeopaths to break all the rules. They still exist.

MHRA cocked it up in 2006

The story starts with the National Regulation Scheme for homeopathic junk that was introduced by the MHRA in 2006. This allowed, for the first time, indications to be put on the labels of the bottles of sugar pills. There were howls of outrage from just about every scientific organisation (the medical establishment was, as usual, more pusillanimous, with some honourable exceptions). The history is related here in the following posts.

The Royal Society speaks out on CAM

Learned Societies speak out against CAM, and the MHRA

The MHRA loses the plot: it allows mislabelling of Arnica gel

House of Lords slams homeopathy and the MHRA

The Science and Technology Select Committee report

This was an admirable effort, It extracted, with some difficulty, admissions from Boots’ professional standards director that the sold pills while knowing that they didn’t work. It also squeezed out of the then Health Minister, Mike O’Brien an admission that they don’t work, Less surprisingly, the head of the MHRA agreed that they don’t work. So it is unanimous (apart, of course, from those who make money from selling things that don’t work).

If you want to know more about Boots’ Professional standards, take a look at Mis-education at Boots the Chemist, or The Vitamin B scam. Don’t trust Boots, or Boots reaches new level of dishonesty with CoQ10 promotion, to name but a few. The oral sessions of the committee were notable for the squirming evasiveness of most of the answers to simple questions. An account can be found in Comedy gold in parliament and tragedy from Prince of Wales: editorial in British Medical Journal

The Government’s response to the report was mostly as truly pathetic bit of official waffle, like those letters you get when you write to your Member of Parliament. But it did contain one good thing."In order for the public to make informed choices, it is therefore vitally important that the scientific evidence base for homeopathy is clearly explained and available." (though even that statement is attributed to John Beddington, the Government’s Chief Scientific advisor, rather than something the Government thinks essential).

"“The MHRA will review the labelling requirements under the NRS to ensure that these deliver clarity as to the status of products and their composition."

The proposals in the MHRA Consultation document’

There are a couple of good things in the proposals. The MHRA proposes to end PLRs (decades overdue, but nonetheless welcome).

The MHRA proposes to stop ‘regulating’ (ho ho) “Bach Flower Remedies” as medicines (but seems happy to classify them as food Supplements, another weasel description to evade sensible regulation). That’s sensible because they aren’t medicines. Homeopathic pills most certainly aren’t medicines either but the MHRA seems to have difficulty grasping that, and wants to treat them quite differently from “Flower remedies”

More honest labelling was about the only sensible thing recommended by the Government’s response. On this topic the MHRA proposals verge on the laughable

At present the labelling allowed under the NRS includes

“A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of ….”

It is proposed to change this to

“A homeopathic medicinal product licensed only on the basis of safety, quality and use within the homeopathic tradition”

“A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of……”

Spot the difference!

The is utterly inadequate. In fact it verges on the pathetic (and on the dishonest). Here is an extract from my full response.

"Sad to say these proposals to remedy the labelling problem are wholly inadequate. They are almost as deceptive as the originals. These labels don‘t come anywhere near to fulfilling the requirement in the government‘s response which said

In order for the public to make informed choices, it is therefore vitally important that the scientific evidence base for homeopathy is clearly explained and available

Why, oh why, cannot the MHRA bring itself to simply tell the truth? It seems to be so stifled by some perversion of political correctness that it is unable to do what it must know is right.

Nothing indicates more clearly the ludicrous state of the NRS than the label approved for Arnica 30C pills.

The approved label says

"ACTIVE INGREDIENT
Each pill contains 30C Arnica Montana
Also contains: lactose and sucrose"

The MHRA must decide whether or not it believes Avogadro‘s number or not.

How many people in the general public realise the ―Each pill contains 30C Arnica Montana‖ means that the ―pills contain no Arnica whatsoever‖? The very mention of the words ―active ingredient‖ will suggest to most people that there is an active ingredient when there is not. This wording alone is both dishonest and deceptive.

The rest of the approved label consists largely of make-believe too.

"If you are pregnant or breastfeeding consult your doctor before use"

What is your doctor meant to advise you about the dangers of taking a few mg of sugar when you are pregnant?

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

Unless the MHRA has disavowed Avogadro‘s number, an overdose is impossible. To allow a label like this makes the MHRA a laughing stock

Labels should tell the truth in plain language. For example they should say

This product contains no Arnica

There is no evidence that it works for any condition, other than as a placebo

Some comments on regulation of magic medicine

Governments like to regulate things. They should have regulated the banks a bit more. The problem arises when you try to regulate things that are myths. Like homeopathy.

Andy Lewis has recently written a superb account of the problems on his Quackometer blog, When the Regulator Believes in Fairies, Who Protects the Public?

The government appears to believe that "training" will solve all the problems. Training people to believe things that aren’t true can never solve problems. On the contrary, it creates problems. Organisations like the Complementary and Natural Health Care Council (CNHC)do nothing to protect the public, They endanger the public (see Why the CNHC can’t succeed). Their excuse for rejecting complaints that members were making false claims was not to deny that the claims were false, but to say that it didn’t matter because that is what they had been trained to say. That is make-believe regulation.

Follow-up

.This is Andy Lewis’s version of an honest label. It looks quite accurate to me.

27 January 2011

News today makes one despair of the morality of governments. Remember those obviously fraudulent bomb detectors, no more than a dowsing rod? Although they are now the subject of a fraud investigation, they are still being sold. The government has banned their export to Iraq and Afghanistan, but NOT to anywhere else, This suggests not only that the government is (or at least was) quite happy to believe in dowsing. It also implies that even when they realise that it’s fraud they take the view that that business is far more important than even the most basic morality. No doubt they will allow fraudulent labelling of medicines in order to protect the homeopathic industry

Does politics have to be quite so disgusting?

28 January 2011. An excellent post on a similar topic is that referred to in a comment below. The MHRA and the non-regulation of homeopathy explains the European background better that I have done.

11 February 2011. Here is a characteristically beautiful response to the consultation by Prof John C. McLachlan, who has allowed me to post it here [download pdf].

 Yesterday I was fired from the Conduct and Competence Committee of the CNHC. That is the organisation that was very quickly dubbed Ofquack in the blogosphere.  So now I am free to write what I like about about it.

It has now become clear that voluntary self-regulation can not work. Recent events at the CNHC show how it has become a victim of its own rules [skip the background].

Background

The CNHC was the product of the late unlamented Prince of Wales’ Foundation for Integrated Health. The Prince’s Foundation was paid a large amount of taxpayers’ money, £900,000, by the Department of Health to come up with a scheme for voluntary self-regulation of various sorts of alternative medicine.

There is, as usual, an enormous amount of relevant information can be found on the ebm-first site.

I posted a bit about Ofquack just before I joined them.  There were two main points. One was to draw attention to the wonderful account of CNHC by Polly Toynbee, "Quackery and superstition – available soon on the NHS",   The other was to point out an obvious problem with the job they were supposed to do.

“What won’t work is to insist that homeopaths are “properly trained”. If one takes the view that medicines that contain no medicine can’t work, then years of being trained to say that they do work, and years spent memorizing the early 19th century mumbo-jumbo of homeopathy, does not protect the public, it imperils them.”

On 25 September 2008, someone sent me an advertisement for a job on the conduct and competence committee. The job description seemed to fit me quite well, so I applied. I presumed they wouldn’t take me, and then I could write a blog about it. But after a phone interview with co-chair Maggy Wallace, I was amazed to be offered the job.

Since joining them I haven’t actually done anything whatsoever, apart from offering a few general ideas, because no cases have actually reached the Conduct and Competence Committee.

This was the first time I had encountered a quango at first hand. Several of the members seemed to have no great interest in medicine, or even in alternative medicine. They were more interested in regulation per se, or at least the sort of pseudo-regulation that most of these bodies mostly seem to offer. They seem to suffer from the well-known delusion that you can manage/regulate something without knowing anything about it.  In cases such as this one, where what is being regulated is largely nonsense, there are bound to be problems.

There were two people, whom I did come to like particularly, Maggy Wallace and John Lant. They were both willing to talk and to listen.

The anonymous emails

The alternative medicine community took a surprisingly long time to notice my presence, but on 19 May 2010 a pretty vicious anonymous email arrived at the CNHC, complaining about me.  Here it is.

Nobody seems to know the real name of Sara Glougan (aka Sam McGlougan.  The letter is, I suppose, fair enough. I did say most of those things.  What’s objectionable is that the anonymous writer seems to think that my opinions disqualify me from judging dispassionately a Conduct and Competence case.  What this letter really says is that "we don’t want anyone who cares about the truth of claims to have any power over us".  They just don’t want to be regulated in any effective way.  The co-chair, Maggy Wallace, is a bit more sensible than that.  The reason that I was appointed by her was because of my knowledge about how to assess evidence. But that isn’t a topic that interests alternative medicine advocates.

The fact of the matter is that the CNHC has been signing up people at a far slower rate than it hoped originally.  It is in dire financial trouble (see, for example, Will the government bail out Ofquack?>, and CNHC’s report to the Department of Health in June 2009, obtained under the Freedom of Information Act.. The last thing they can afford is anything like this letter, which might reduce the registration rate still further. So it was inevitable that they had to get rid of me. Initially I was invited to resign on grounds of bad health. I didn’t, so on 10 August 2010 I was asked to appear before the board to be fired (in the nicest possible way). The CNHC now has nobody with any statistical expertise. Needless to say I’m not heartbroken about it. It was a waste of time for me, but it did provide a valuable insight into how voluntary self-regulation works, or rather fails to work.

The complaints against reflexologists

The CNHC has a complaints procedure, though its operation is somewhat tortuous.. As soon as they started to register reflexologists, several complaints were sent by the indefatigable Simon Perry (read his account)

“The ad suggests that reflexology is suitable for treating babies with colic, IBS and arthritis. She also claims to have experience in treating fertility issues. There is no reliable evidence to suggest that reflexology is capable of treating [these] issues.”

This complaint never came to to the Conduct and Competence Committee. It didn’t get past the preliminary Investigating Committee (chaired by John Lant), the job of which is to see if there is a case to answer. They decided that the advertisements in question did indeed breach paragraph 15 of the CNHC’s Code of Conduct, Performance and Ethics (see below). All 14 of Simon Perry’s complaints were upheld. However the Investigating Committee Panel’s report went on to say, apparently on the advice of the ‘Profession specific boards’ that

“The ICP found that the registrants’ Fitness to Practise was not impaired, because they did not deliberately seek to mislead their clients or to exaggerate the benefits of the therapy which they described in good faith. However they found that the registrants had made claims about the therapy offered which appeared to imply more efficacy than evidence necessarily provides.”

That, presumably, is why the complaints never reached the Conduct and Competence Committee. There was no case to answer.

One must admire Maggy Wallace’s statement that she “place on formal record their thanks to Simon Perry for bringing this matter to their attention.”.   Never the less the problem is glaringly obvious and it shouldn’t have need a complaint.

Why ofquack can never work

The complaint episode is fascinating. The CNHC has clearly painted itself into a corner. It has brought to the fore all the contradictions that are inherent in what they are trying to do.

They have decided that reflexologists make false claims about what they can achieve.

But they decided it wasn’t the fault of the reflexologists because that is what they had been taught

Therefore the CNHC has judged that fitness of reflexologists to practise is not affected by the fact that they make false health claims.

That means that the CNHC judges that the public safety is not affected by whether their members make false health claims. That seems ludicrous enough, but it goes further

In the initial publicity it was often said that the job of the CNHC was safety -their job to protect the public, not to judge whether treatments worked or not. That sort of statement is contradicted directly by paragraph 15 of their Code of Conduct, Performance and Ethics, which reads thus.

Any advertising you undertake in relation to your professional activities must be accurate. Advertisements must not be misleading, false, unfair or exaggerated. You must not claim that your personal skills, equipment or facilities are better than anyone else’s.

If you are involved in advertising or promoting any other product or service, you must make sure that you use your knowledge, healthcare skills, qualifications and experience in an accurate and professionally responsible way. You must not make or support unjustifiable statements relating to particular products or services. Any potential financial rewards to you should be made explicit and play no part at all in your advice or recommendations of products and services that you give to patients, clients and users.

This paragraph places on the CNHC the responsibility for judging whether or not a treatment does what’s claimed for it. With my departure, there is really nobody left who is well-qualified to do that,
but nonetheless, their judgement on claims made by reflexologists was quite right.

The assertion by the CNHC that the false claims were OK because that is what reflexologists are taught is a direct admission that the courses that ‘train’ reflexologists are teaching them to say things that are not true. Of course the rest of the world knew that already, but to have it admitted by the CNHC is amazing.

Part of the job of the CNHC is to judge whether registrants are properly trained. But they have just decided that courses for reflexologists teach them to say things that aren’t true, That leaves the CNHC it an impossible position. By accepting reflexologists, they are saying that it doesn’t really matter that they are taught to make false claims, The criteria for entry include

“Have undertaken a programme of education and training which meets, as a minimum, the National Occupational Standards for that profession/discipline”

This shifts the responsibility for deciding what’s acceptable to National Occupational Standards and Skills for Health. Neither of these quangos is in the least concerned about what’s true and what isn’t. That’s not surprising when you realise who drafted all the HR style nonsense to be found at Skills for Health? None other than the late Prince of Wales’ Foundation. The stuff produced by them isn’t worth the paper it’s written on. There is something about Skills for Health in the post where I recount a phone call with them, When I asked whether they would produce standards for talking to trees, I was referred, in all seriousness, to LANTRA, the Land based skills council. You couldn’t make it up.

The National Occupational Standards (NOS) directory leads to the NOS for reflexology.  The preamble says

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

There is, if course, not a shred of reason to think that “areas in the feet and hands that relate to corresponding parts of the body”. This statement alone would fail the CNHC’s code of conduct. National Occupational Standards in this area are simply a farce.

What will the CNHC do about these paradoxes? The complaint report said

“The ICP have asked Maggie Dunn, the CNHC Registrar, to initiate, as a matter of priority, discussions with the CNHC’s Profession Specific Boards and the Professional Fora to agree advice to registrants in relation to paragraph 15.”

I was told that this might take between 3 and 5 years to do. But I have a strong feeling that it will never be done in any effective way. If the CNHC prevented training courses from teaching students to make claims that aren’t justified by evidence, just about every course would close and the CNHC would crumble to dust. The result would be the ultimate irony. Alternative medicine would be abolished, not by skeptics, but by the CNHC.

That follows inevitably from the complaint judgement combined with paragraph 15 of the code of conduct.

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

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

Follow-up

Interview for Pod Delusion on the CNHC case

Snow on December 18th                             Roaring fire

Lindy contributes acute comments regularly here.  She is also an accomplished musician.  She has kindly allowed me to post here four of her re-written carols.

The Middle English dialect is not easy to follow. In fact Wikipedia reveals that it is oit even standard Middle English, but Macaronic English. The original words are reproduced in the right hand column.  The original, sung by choir of King’s College Chapel, is on YouTube.

 Atoms lay y’bounden In primordial soup; Six billion years did pass A’fore they could regroup. For first had bin a big bang The universe was shook; Though through milennia For god it was mistook. Then particles of light did shine, ema- -nating from the sun. Out of soup arose archaea And so life was begun. Thanks be to the man This mystery did solve; Through him we celebrate how we Did from the bugs evolve. Adam lay ybounden, Bounden in a bond: Four thousand winter Thought he not too long. And all was for an apple, An appil that he took, As clerkè finden Written in their book. Ne had the apple taken been, The appil taken been, Ne had never our lady Abeen heavenè queen. Blessèd be the time That appil taken was, Therefore we moun singen, Deo gracias! .

Hark the Herald Angels sing.

This version is for Simon Singh. If you haven’t yet signed the new peition, please do it here.

Mark this very dang’rous thing,

Story is of Simon Singh.

He got chiropractors riled,

“Sod it! We have been defiled!

Ployful all ye woosters rise,

Subluxations are our game”

Christ, they all with one accord

Took young Simon off to court.

“We’ll put you before a judge,

Since we always bear a grudge

‘Gainst all those who say our modus

Operandi is all bogus;

Mark the words of justice Eady,

Gave his ruling oh so speedy.

Mark the case of Simon Singh

With support the web does ring.

Ditch draconian libel laws,

Without which they’d have no cause

To sue those who would speak freely,

Truth, opinion-and reason really

Should prevail o’er all such things,

Surely he his case must win.

The Holly and the Ivy

Dedicated to the Prince of Wales, certain vice-chancellors and other champions of the endarkenment.

The folly and the lies, see

How they’ve become full-blown;

The braying of th’quackti’tioner Roy-

Al, th’enlightenment has flown.

Refrain: For deriding all the data

(Such stunning stuff we hear)!

The displaying of such cherry pick-

-Ing, beats bringing in Chi square.

The folly hears no critics

It makes you quite struck dumb,

Just put a poison substance in,

And dilute to kingdom come.

For deriding all the data etc.

The folly so does blossom,

Beguiles you with its charm,

Just make some movements with your wrist

And it will do no harm.

For deriding all the data etc.

The folly’s given credence

If you are qualified

With a BSc in pseudosci-

-Ence, th’endarkenment is nigh!

For deriding all the data etc.

The folly bears a burden

Now it has fallen down;

F.O.I requests and publicity

Have giv’n D.C. the crown.

For deriding all the data etc.

The folly is so fickle,

How did they have the gall

To tell us how their remedies

Were here to treat us all?

For deriding all the data etc.

The folly and the lies, see

How they must surely fail

We’ll drink a toast to good evidence

And let real science prevail!

Alternative refrain:

Oh the rising of the Reiki,

Of acupuncture too,

All Rolfering* and Tuina-ish,

They all amount to woo.

*The names Rolf and Roger seem remarkably similar in some circumstances so I get a little confused.

Merry gentlemen

Here is Lindy’s version of "god rest ye merry gentleman", composed in the wake of the admission by the Professional Standards director of Boots the Chemists that they sell homeopathic pills despite being aware of the fact that there is no reason to think they work.

I arrest you merry gentlemen,

For you are selling sugar pills

For which the people pay;

We’re from the Trading Standards and through courts we’ll find a way

To stop your profit-making ploy, Profiting ploy,

The chemists calmly did defend

Themselves though they were riled;

“The people do demand these pills

Because they’re not defiled

With molecules (nor ‘owt at all), despite the claims so wild;

We’ll continue our profiteering ploy, Profiting ploy,

We’ll continue our profiteering ploy”.

To make more money, though if you

Persist with bogus claim

To cure disease with sugar pills,

We’ll put you all to shame!

We are stopping your profiteering ploy, Profiting ploy,

We are stopping your profiteering ploy”.

“You breach the regulations by selling pills, you see,

Which claim to contain ‘aqua’ (dilute to 30C),

Or ‘dolphin song’ or ‘canine testes’ – even ‘ATP’!

So you’ll stop all this profiteering ploy, profiting ploy,

So you’ll stop all this profiteering ploy”.

The Dept of Health bangs on and on

But all good people must condemn

These lies with one great voice.

We dream of days when fibs are gone and we can all rejoice

‘Cos they’ve stopped all their profiteering ploy, Profiting ploy,

‘Cos they’ve stopped all their profiteering ploy

The Yuletide edition of the BMJ carries a lovely article by Jeffrey Aronson, Patent medicines and secret remedies. (BMJ 2009;339:b5415).

I was delighted to be asked to write an editorial about it, In fact it proved quite hard work, because the BMJ thought it improper to be too rude about the royal family, or about the possibility of Knight Starvation among senior medics. The compromise version that appeared in the BMJ is on line (full text link).

The changes were sufficient that it seems worth posting the original version (with links embedded for convenience).

The cuts are a bit ironic, since the whole point of the article is to point out the stifling political correctness that has gripped the BMA, the royal colleges, and the Department of Health when it comes to dealing with evidence-free medicine. It has become commonplace for people to worry about the future of the print media, The fact of the matter is you can often find a quicker. smarter amd blunter response to the news on blogs than you can find in the dead tree media. I doubt that the BMJ is in any danger of course. It has a good reputation for its attitude to improper drug company influence (a perpetual problem for clinical journals) as well as for clinical and science articles.  It’s great to see its editor, Fiona Godlee, supporting the national campaign for reform of the libel laws (please sign it yourself).

The fact remains that when it comes to the particular problem of magic medicine, the action has not come from the BMA, the royal colleges, and certainly not from the Department of Health, It has come from what Goldacre called the “intrepid, ragged band of bloggers”. They are the ones who’ve done the investigative journalism, sent complaints and called baloney wherever they saw it. This article was meant to celebrate their collective efforts and to celebrate the fact that those efforts are beginning to percolate upwards to influence the powers that be.

It seems invidious to pick on one example, but if you want an example of beautiful and trenchant writing on one of the topics dealt with here, you’d be better off reading Andrew Lewis’s piece "Meddling Princes, Medical Regulation and Licenses to Kill” than anything in a print journal.

I was a bit disappointed by removal of the comment about the Prince of Wales.  In fact I’m not particularly republican compared with many of my friends.  The royal family is clearly good for the tourist industry and that’s important.  Since Mrs Thatcher (and her successors) destroyed large swathes of manufacturing and put trust in the vapourware produced by dishonest and/or incompetent bankers, it isn’t obvious how the UK can stay afloat.  If tourists will pay to see people driving in golden coaches, that’s fine.  We need the money.  What is absolutely NOT acceptable is for royals to interfere in the democratic political process.  That is what the Prince of Wales does incessantly.  No doubt he is well-meaning, but that is not sufficient.  If I wanted to know the winner of the 2.30 at Newmarket, it might make sense to ask a royal.  In medicine it makes no sense at all.  But the quality of the advice is irrelevant anyway.  The royal web site itself says “As a constitutional monarch, the Sovereign must remain politically neutral.”. Why does she not apply that rule to her son? Time to put him over your knee Ma’am?

Two of the major bits that were cut out are shown in bold, The many other changes are small.

BMJ editorial December 2009

Secret remedies: 100 years on

Time to look again at the efficacy of remedies

Jeffrey Aronson in his article [1] gives a fascinating insight into how the BMA, BMJ and politicians tried, a century ago, to put an end to the marketing of secret remedies.  They didn’t have much success.

The problems had not improved 40 years later when A.J. Clark published his book on patent medicines [2]. It is astounding to see how little has changed since then.  He wrote, for example, “On the other hand the quack medicine vendor can pursue his advertising campaigns in the happy assurance that, whatever lies he tells, he need fear nothing from the interference of British law. The law does much to protect the quack medicine vendor because the laws of slander and libel are so severe.”>  Clark himself was sued for libel after he’d written in a pamphlet “ ‘Cures’ for consumption, cancer and diabetes may fairly be classed as murderous”. Although he initially tried to fight the case, impending destitution eventually forced him to apologise [3].  If that happened today, the accusation would have been repeated on hundreds of web sites round the world within 24 hours, and the quack would, with luck, lose [4].

As early as 1927, Clark had written “Today some travesty of physical science appears to be the most popular form of incantation” [5].  That is even more true today.  Homeopaths regularly talk utter nonsense about quantum theory [6] and ‘nutritional therapists’ claim to cure AIDS with vitamin pills or even with downloaded music files.  Some of their writing is plain delusional, but much of it is a parody of scientific writing. The style, which Goldacre [7] calls ‘sciencey’, often looks quite plausible until you start to check the references.

A 100 years on from the BMA’s efforts, we need once again to look at the efficacy of remedies.  Indeed the effort is already well under way, but this time it takes a rather different form.  The initiative has come largely from an “intrepid, ragged band of bloggers” and some good journalists, helped by many scientific societies, but substantially hindered by the BMA, the Royal Colleges, the Department of Health and a few vice-chancellors.  Even NICE and the MHRA have not helped much.  The response of the royal colleges to the resurgence in magic medicine that started in the 1970s seems to have been a sort of embarrassment.  They pushed the questions under the carpet by setting up committees (often populated with known sympathizers) so as to avoid having to say ‘baloney’.  The Department of Health, equally embarrassed, tends to refer the questions to that well-known medical authority, the Prince of Wales (it is his Foundation for Integrated Health that was charged with drafting National Occupational Standards in make-believe subjects like naturopathy [8].

Two recent examples suffice to illustrate the problems.

The first example is the argument about the desirability of statutory regulation of acupuncture, herbal and traditional Chinese medicine (the Pittilo recommendations) [9].

Let’s start with a definition, taken from ‘A patients’ guide to magic medicine’ [10]. “Herbal medicine: giving patients an unknown dose of an ill-defined drug, of unknown effectiveness and unknown safety”.

It seems to me to be self-evident that you cannot start to think about a sensible form of regulation unless you first decide whether what you are trying to regulate is nonsense, though this idea does not seem to have penetrated the thinking of the Department of Health or the authors of the Pittilo report.  The consultation on statutory regulation has had many submissions [11] that point out the danger to patients of appearing to give official endorsement of treatments that don’t work.  The good news is that there seems to have been a major change of heart at the Royal College of Physicians.  Their submission points out with admirable clarity that the statutory regulation of things that don’t work is a danger to patients (though they still have a blank spot about the evidence for acupuncture, partly as a result of the recent uncharacteristically bad assessment of the evidence by NICE [12]).  Things are looking up.  Nevertheless, after the public consultation on the report ended on November 16th, the Prince of Wales abused his position to make a well-publicised intervention on behalf of herbalists [13]Sometimes I think his mother should give him a firm lesson in the meaning of the term ‘constitutional monarchy’, before he destroys it.

The other example concerns the recent ‘evidence check: homeopathy’ conducted by the House of Commons Science and Technology Select Committee (SCITECH). First the definition [10]: “Homeopathy: giving patients medicines that contain no medicine whatsoever”.  When homeopathy was dreamt up, at the end of the 18th century, regular physicians were lethal blood-letters, and it’s quite likely that giving nothing saved people from them.  By the mid-19th century, discoveries about the real causes of disease had started, but homeopaths remain to this day stuck in their 18th century time warp.

In 1842 Oliver Wendell Holmes said all that needed to be said about medicine-free medicine [14].  It is nothing short of surreal that the UK parliament is still discussing it in 2009.  Nevertheless it is worth watching the SCITECH proceedings [15].  The first two sessions are fun, if only for the statement by the Professional Standards Director of Boots that they sell homeopathic pills while being quite aware that they don’t work.  I thought that was rather admirable honesty.  Peter Fisher, clinical director of the Royal Homeopathic Hospital, went through his familiar cherry-picking of evidence, but at least repeated his condemnation of the sale of sugar pills for the prevention of malaria.

But for pure comedy gold, there is nothing to beat the final session.  The health minister, Michael O’Brien, was eventually cajoled into admitting that there was no good evidence that homeopathy worked but defended the idea that the taxpayer should pay for it anyway.  It was much harder to understand the position of the chief scientific advisor in the Department of Health, David Harper.  He was evasive and ill-informed.  Eventually the chairman, Phil Willis, said “No, that is not what I am asking you. You are the Department’s Chief Scientist. Can you give me one specific reference which supports the use of homeopathy in terms of Government policy on health?”.  But answer came there none (well, there were words, but they made no sense).

Then at the end of the session Harper said “homeopathic practitioners would argue that the way randomised clinical trials are set up they do not lend themselves necessarily to the evaluation and demonstration of efficacy of homeopathic remedies, so to go down the track of having more randomised clinical trials, for the time being at least, does not seem to be a sensible way forward.”  Earlier, Kent Woods (CEO of the MHRA) had said “the underlying theory does not really give rise to many testable hypotheses”.  These two eminent people seemed to have been fooled by the limp excuses offered by homeopaths.  The hypotheses are testable and homeopathy, because it involves pills, is particularly well suited to being tested by proper RCTs (they have been, and when done properly, they fail).  If you want to know how to do it, all you have to do is read Goldacre in the Guardian [16].

It really isn’t vert complicated.   “Imagine going to an NHS hospital for treatment and being sent away with nothing but a bottle of water and some vague promises.”  “And no, it’s not a fruitcake fantasy. This is homeopathy and the NHS currently spends around £10million on it.”

That was written by health journalist Jane Symons, in The Sun [17].  A Murdoch tabloid has produced a better account of homeopathy than anything that could be managed by the chief scientific advisor to the Department of Health.  And it isn’t often that one can say that.

These examples serve to show that the medical establishment is slowly being dragged, from the bottom up, into realising that matters of truth and falsehood are more important than their knighthoods.  It is all very heartening, both for medicine and for democracy itself.

David Colquhoun.

Declaration of interests. I was A.J. Clark chair of pharmacology at UCL, 1985 – 2004.

1.  Aronson, JK BMJ 2009;339:b5415

2.  Clark, A,J, (1938) Patent Medicines FACT series 14, London.  See also Patent medicines in 1938 and now  http://www.dcscience.net/?p=257
(A.J. Clark FRS was professor of Pharmacology at UCL from 1919 to 1926, and subsequently in Edinburgh).

3.  David Clark “Alfred Joseph Clark, A Memoir” (C. & J. Clark Ltd 1985 ISBN 0-9510401-0-3)

4.  Lewis, A. (2007) The Gentle Art of Homeopathic Killing

5.  A.J. Clark (1927) The historical aspect of quackery, BMJ October 1st 1927

6.  Chrastina, D  (2007) Quantum theory isn’t that weak,  (response to Lionel Milgrom).

7  Goldacre, B. (2008) Bad Science. HarperCollins

8. Skills for Health web site
The ‘competences’ have been revised since the account at http://www.dcscience.net/?p=215#sfh, but are still preposterous make believe.

10. A Patients’ Guide to Magic Medicine,  and also in the Financial Times.

13. BBC news 1 December 2009 Prince Charles: ‘Herbal medicine must be regulated’.

14.  Oliver Wendell Holmes (1842) Homeopathy and Its Kindred Delusions.

15.  House of Commons Science and technology committee. Evidence check: homeopathy. Videos and transcripts available at  http://www.viewista.com/s/fywlp2/ez/1

16.  Goldacre, B.  A Kind of Magic  Guardian  16 November 2007.

17.   Homeopathy is resources drain says
Jane Symons.  The Sun 2 December 2009.

Follow-up

There is a good account of the third SCITECH session by clinical science consultant, Majikthyse, at The Three Amigos.

16 December 2009.. Recorded an interview for BBC Radio 5 Live. It was supposed to go out early on 17th.

17 December 2009.  The editorial is mentioned in Editor’s Choice, by deputy editor Tony Delamothe. I love his way of putting the problem "too many at the top of British medicine seem frozen in the headlights of the complementary medicine bandwagon".  He sounds remarkably kind given that I was awarded (by the editor, Fiona Godlee, no less) a sort of booby prize at the BMJ party for having generated a record number of emails during the editing of a single editorial (was it really 24?). Hey ho.

17 December 2009.  More information on very direct political meddling by the Prince of Wales in today’s Guardian, and in Press Association report.

17 December 2009Daily Telegraph reports on the editorial, under the heading “ ‘Nonsense’ alternative medicines should not be regulated“. Not a bad account for a non-health journalist.

17 December 2009. Good coverage in the excellent US blog, Neurologica, by the superb Steven Novella.’ “Intrepid, Ragged Band of Bloggers” take on CAM‘ provides a chance to compare and contrast the problems in the UK and the USA.’

18 December 2009.  Article in The Times by former special advisor, Paul Richards. “The influence of Prince Charles the lobbyist is out of hand. Our deference stops us asking questions.”

“A good starting point might be publication of all correspondence over the past 30 years. Then we will know the extent, and influence, of Prince Charles the lobbyist.”

Comments in the BMJ Quite a lot of comments had appeared by January 8th, though sadly they were mostly from the usual suspects who appear every time one suggests evidence matters. A reply was called for, so I sent this (the version below has links).

After a long delay, this response eventually appeared in the BMJ on January 15 2010.

It’s good to see so many responses, though somewhat alarming to see that several of them seem to expect an editorial to provide a complete review of the literature.  I ‘ll be happy to provide references for any assertion that I made.

I also find it a bit odd that some people think that an editorial is not the place to express an opinion robustly.  That view seems to me to be a manifestation of the very sort of political correctness that I was deploring.  It’s a bit like the case when the then health minister, Lord Hunt, referred to psychic surgery as a “profession” when he should have called it a fraudulent conjuring trick.  Anything I write is very mild compared with what Thomas Wakley wrote in the Lancet, a journal which he founded around the time UCL came into existence. For example (I quote)

“[We deplore the] “state of society which allows various sets of mercenary, goose-brained monopolists and charlatans to usurp the highest privileges…. This is the canker-worm which eats into the heart of the medical body.” Wakley, T. The Lancet 1838-9, 1

I don’t think it is worth replying to people who cite Jacques Benveniste or Andrew Wakefield as authorities.  Neither is it worth replying to people who raise the straw man argument about wicked pharmaceutical companies (about which I am on record as being as angry as anyone).  But I would like to reply directly to some of the more coherent comments.

Sam Lewis and Robert Watson. [comment] Thank you for putting so succinctly what I was trying to say.

Peter Fisher [comment].  I have a lot of sympathy for Peter Fisher.  He has attempted to do some good trials of homeopathy (they mostly had negative outcomes).  He said he was "very angry" when the non-medical homeopaths  were caught out recommending their sugar pills for malaria prevention (not that this as stopped such dangerous claims which are still commonplace).  He agreed with me that there was not sufficient scientific basis for BSc degrees in homeopathy.  I suppose that it isn’t really surprising that he continues to cherry pick the evidence.  As clinical director of the Royal London Homeopathic Hospital and Homeopathic physician to the Queen,  just imagine the cognitive dissonance that would result if he were to admit publicly that is all placebo after all.  He has come close though. His (negative) trial for homeopathic treatment of rheumatoid arthritis included the words "It seems more important to define if homeopathists can genuinely control patients’ symptoms and less relevant to have concerns about whether this is due to a ‘genuine’ effect or to influencing the placebo response” [2]. [download
the paper
].  When it comes to malaria, it matters a lot.

Adrian White [comment] seems to be cross because I cited my own blog.   I did that simply because if he follows the links there he will find the evidence.  In the case of acupuncture it has been shown time after time that "real" acupuncture does not differ perceptibly from sham.  That is true whether the sham consists of retractable needles or real needles in the "wrong" places.  A non-blind comparison between acupuncture and no acupuncture usually shows some advantage for the former but it is, on average, too small to be of much clinical significance [3]. I agree that there is no way to be sure that this advantage is purely placebo effect but since it is small and transient it really doesn’t matter much.  Nobody has put it more clearly than Barker Bausell in his book, Snake Oil Science [4]

White also seems to have great faith in peer review.  I agree that in real science it is probably the best system we have.  But in alternative medicine journals the "peers" are usually other true believers in whatever hocus pocus is being promoted and peer reveiw breaks down altogether.

R. M. Pittilo [comment] I’m glad that Professor Pittilo has replied in person because I did single out his report for particular criticism.  I agree that his report said that NHS funding should be available to CAM only where there is evidence of efficacy.  That was not my criticism.  My point was that in his report, the evidence for efficacy was assessed by representatives of Herbal Medicine, Chinese Medicine and Acupuncture (four from each).  Every one of them would have been out of work if they had found their subjects were nonsense and that, no doubt, explains why the assessment was so bad.  To be fair, they did admit that the evidence was not all that it might be and recommended (as always) more research   I’d like to ask Professor Pittilo how much money should be spent on more research in the light of the fact that over a billion dollars has been spent in the USA on CAM research without producing a single useful treatment.  Pittilo says "My own view is that both statutory regulation and the quest for evidence should proceed together" but he seems to neglect the possibility that the quest for evidence might fail. Experience in the USA suggests that is exactly what has, to a large extent, already happened.

I also find it quite absurd that the Pittilo report should recommend, despite a half-hearted admission that the evidence is poor, that entry to these subjects should be via BSc Honours degrees.  In any case he is already thwarted in that ambition because universities are closing down degrees in these subjects  having realised that the time to run a degree is after, not before, you have some evidence that the subject is not nonsense.  I hope that in due course Professor Pittilo may take the same action about the courses in things like homeopathy that are run by the university of which he is vice-chancellor.  That could only enhance the academic reputation of Robert Gordon’s University.

George Lewith [comment]  You must be aware that the proposed regulatory body, the Health Professions Council, has already broken its own rules about "evidence-based practice" by agreeing to take on, if asked, practitioners of Herbal Medicine, Chinese Medicine and Acupuncture.  They have (shamefully) excluded the idea that claims of efficacy would be regulated.  In other word they propose to provide exactly the sort of pseudo-regulation which would endanger patients   They are accustomed to the idea that regulation is to do only with censoring practitioners who are caught in bed with patients.  However meritorious that may be, it is not the main problem with pseudo-medicine, an area in which they have no experience.  I’m equally surprised that Lewith should recommend that Chinese evaluation of Traditional Chinese medicine should be included in meta-analyses, in view of the well-known fact that 99% of evaluations from China are positive: “No trial published in China or Russia/USSR found a test treatment to be ineffective” [5]. He must surely realise that medicine in China is a branch of politics.  In fact the whole resurgence in Chinese medicine and acupuncture in post-war times has less to do with ancient traditions than with Chinese nationalism, in particular the wish of Mao Tse-Tung to provide the appearance of health care for the masses (though it is reported that he himself preferred Western Medicine).

1. Lord Hunt thinks “psychic surgery” is a “profession”. http://www.dcscience.net/?p=258

2. Fisher, P. Scott, DL. 2001 Rheumatology 40, 1052 – 1055.   [pdf file]

3. Madsen et al, BMJ 2009;338:a3115  [pdf file]

4. R, Barker Bausell, Snake Oil Science, Oxford University Press, 2007

5. Vickers, Niraj, Goyal, Harland and Rees (1998, Controlled Clinical Trials, 19, 159-166) “Do Certain Countries Produce Only Positive Results? A Systematic Review of Controlled Trials”. [pdf file]

15 January 2010. During the SciTech hearings, Kent Woods (CEO of the MHRA) made a very feeble attempt to defend the MHRA’s decision to allow misleading labelling of homeopathic products. Now they have published their justification for this claim. It is truly pathetic, as explained by Martin at LayScience: New Evidence Reveals the MHRA’s Farcical Approach to Homeopathy. This mis-labelling cause a great outcry in 2006, as documented in The MHRA breaks its founding principle: it is an intellectual disgrace, and Learned Societies speak out against CAM, and the MHRA.

22 January 2010 Very glad to see that the minister himself has chosen to respond in the BMJ to the editorial

 Rt Hon. Mike O’Brien QC MP, Minister of State for Health Services I am glad that David Colquhoun was entertained by my appearance before the Health Select Committee on Homeopathy. But he is mistaken when he says, “you cannot start to think about a sensible form of regulation unless you first decide whether or not the thing you are trying to regulate is nonsense.” Regulation is about patient safety. Acupuncture, herbal and traditional Chinese medicine involve piercing the skin and/or the ingestion of potentially harmful substances and present a possible risk to patients. The Pittilo Report recommends statutory regulation and we have recently held a public consultation on whether this is a sensible way forward. Further research into the efficacy of therapies such as Homeopathy is unlikely to settle the debate, such is the controversy surrounding the subject. That is why the Department of Health’s policy towards complementary and alternative medicines is neutral. Whether I personally think Homeopathy is nonsense or not is besides the point. As a Minister, I do not decide the correct treatment for patients. Doctors do that. I do not propose on this occasion to interfere in the doctor-patient relationship.

Here is my response to the minister

Both the minister’s response, and my reply, were reformatted to appear as letters in the print edition of the BMJ, as well as comments on the web..

It seems very reasonable to suggest that taxpayers have an interest in knowing what is taught in universities.  The recent Pittilo report suggested that degrees should be mandatory in Acupuncture, Herbal Medicine and Traditional Chinese Medicine. So it seems natural to ask to see what is actually taught in these degrees, so one can judge whether it protects the public or endangers them.

Since universities in the UK receive a great deal of public money, it’s easy.  Just request the material under the Freedom of Information Act.

Well, uh, it isn’t as simple as that.

Every single application that I have made has been refused.  After three years of trying, the Information Commissioner eventually supported my appeal to see teaching materials from the Homeopathy "BSc" at the University of Central Lancashire.  He ruled that every single objection (apart from one trivial one) offered by the universities was invalid.  In particular, it was ruled that univerities were not "commercial" organisations for the purposes of the Act.

So problem solved?  Not a bit of it.  I still haven’t seen any of the materials from the original request because the University of Central Lancashire appealed against the decision and the case of University of Central Lancashire v Information Commissioner is due to be heard on November 3rd, 4th and 5th in Manchester. I’m joined (as lawyers say) as a witness. Watch this space.

UCLan  is not the exception.  It is the rule.  I have sought under the Freedom of Information Act, teaching materials from UClan (homeopathy), University of Salford (homeopathy, reflexology and nutritional therapy), University of Westminster (homeopathy, reflexology and nutritional therapy), University of West of England, University of Plymouth and University of East London, University of Wales (chiropractic and nutritional therapy), Robert Gordon University Aberdeen (homeopathy), Napier University  Edinburgh (herbalism).

In every single case, the request for teaching materials has been refused. And that includes the last three, which were submitted after the decision of the Information Commissioner.  They will send things like course validation documents, but these are utterly uninformative box-ticking documents.  They say nothing whatsoever about what is actually taught.

The fact that I have been able to discover quite a lot about what’s being taught owes nothing whatsoever to the Freedom of Information Act. It is due entirely to the many honest individuals who have sent me teaching materials, often anonymously. We should be grateful to them. Their principles are rather more impressive than those of their principals.

Since this started about three years ago, two of the universities, UCLan and Salford, have shut down entry to all of their CAM courses. And Westminster has shut two of them, with more rumoured to be closing soon. They are to be congratulated for that, but is far from being the end of the matter. The Department of Health, and some of the Royal Colleges, have yet to catch up with the universities, The Pittolo report, which recommends making degrees compulsory, is being considered by the Department of Health. The consultation ends on November 2nd:  if you haven’t yet responded, please do so now (see how here, and here).

A common excuse: the university does not possess teaching materials (yes, really)

Several of the universities claim that they cannot send teaching materials, because they have no access to them. This happens when the university has accredited a course that is run by another, privately run, institution. The place that does the actual teaching, being private, is exempt from the Freedom of Information Act.

The ludicrous corollary of this excuse is that the university has accredited the course without checking on what is taught, and in some cases without even having seen a timetable.

The University of Wales

In fact the University of Wales doesn’t run courses at all. Like the (near moribund) University of London, it acts as a degree-awarding authority for a lot of Welsh Universities. It also validates a lot of courses in non-university institutions, 34 or so of them in the UK, and others scattered round the world.

Many of them are theological colleges. It does seem a bit odd that St Petersburg Christian University, Russia, and International Baptist Theological Seminary, Prague, should be accredited by the University of Wales.

The 34 UK institutions include the Scottish School of Herbal Medicine,  the Northern College of Acupuncture and the Mctimoney College of Chiropractic.

The case of the Nutritional Therapy course has been described already in Another worthless validation: the University of Wales and nutritional therapy. It emerged that the course was run by a grade 1 new-age fantasist. It is worth recapitulating the follow up.

What does the University of Wales say? So far, nothing. Last week I sent brief and polite emails to Professor Palastanga and to

Professor Clement to try to discover whether it is true that the validation process had indeed missed the fact that the course organiser’s writings had been described as “preposterous, made-up, pseudoscientific nonsense” in the Guardian.

So far I have had no reply from the vice-chancellor, but on 26 October I did get an answer from Prof Palastanga.

 As regards the two people you asked questions about – J.Young – I personally am not familiar with her book and nobody on the validation panel raised any concerns about it. As for P.Holford similarly there were no concerns expressed about him or his work. In both cases we would have considered their CV’s as presented in the documentation as part of the teaching team. In my experience of conducting degree validations at over 16 UK Universities this is the normal practice of a validation panel.

I have to say this reply confirms my worst fears. Validation committees such as this one simply don’t do their duty. They don’t show the curiosity that is needed to discover the facts about the things that they are meant to be judging. How could they not have looked at the book by the very person that they are validating? After all that has been written about Patrick Holford, it is simply mind-boggling that the committee seems to have been quite unaware of any of it.

It is yet another example of the harm done to science by an unthinking, box-ticking approach.

Incidentally, Professor Nigel Palastanga has now been made Pro Vice-Chancellor (Quality) at the University of Wales and publishes bulletins on quality control. Well well.

The McTimoney College of Chiropractic was the subject of my next  Freedom of Information request to the University of Wales. The reasons for that are, I guess, obvious. They sent me hundreds of pages of validation documents, Student Handbooks (approx 50 pages), BSc (Hons) Chiropractic Course Document. And so on. Reams of it. The documents mostly are in the range of 40 to 100 pages. Tons of paper, but none of it tells you anyhing whatsover of interest about what’s being taught. They are a testament to the ability of universities to produce endless vacuous prose with
very litlle content.

They did give me enough information to ask for a sample of the teaching materials on particular topics. But I gor blank refusal, on the grounds that they didn’t possess them. Only McTimoney had them. Their (unusually helpful) Freedom of Information officer replied thus.

“The University is entirely clear about the content of the course but the day to day timetabling of teaching sessions is a matter for the institution rather than the University and we do not require or possess timetable information. The Act does not oblige us to request the information but there is no reason you should not approach McTimoney directly on this.”

So the university doesn’t know the timetable. It doesn’t know what is taught in lectures, but it is " entirely clear about the content of the course".

This response can be described only as truly pathetic.

Either this is a laughably crude form of obstruction of my request, or perhaps, even more frighteningly, the university really believes that its endless box-ticking documents actually provide some useful control of quality. Perhaps the latter interpretation is more charitable. After all, the QAA, CHRE, UUK and every HR department share similar delusions about what constitutes quality.

Perhaps it is just yet another consequence of having science run largely by people who have never done it and don’t understand it.

Validation is a business. The University of Wales validates no fewer than 11,675 courses altogether. Many of these are perfectly ordinary courses in universities in Wales, but they validate 594 courses at non-Welsh accredited institutions, an activity that earned them £5,440,765 in the financial year 2007/8. There’s nothing wrong with that if they did the job properly. In the two cases I’ve looked at, they haven’t done the job properly. They have ticked boxes but they have not looked at what’s being taught or who is teaching it.

The University of Kingston

The University of Kingston offers a “BSc (Hons)” in acupuncture. In view of the fact that the Pittilo group has recommended degrees in acupuncture, there is enormous public interest in what is taught in such degrees, so I asked.

They sent the usual boring validation documents and a couple of sample exam papers . The questions were very clinical, and quite beyond the training of acupuncturists.  The validation was done by a panel of three, Dr Larry Roberts (Chair, Director of Academic Development, Kingston University), Mr Roger Hill (Accreditation Officer, British Acupuncture Accreditation Board) and Ms Celia Tudor-Evans (Acupuncturist, College of Traditional Acupuncture, Leamington Spa).   So nobody with any scientific expertise, and not a word of criticism.

 Further to your recent request for information I am writing to advise that the University does not hold the following requested information: (1) Lecture handouts/notes and powerpoint presentations for the following sessions, mentioned in Template 3rd year weekend and weekday course v26Aug2009_LRE1.pdf (a) Skills 17: Representational systems + Colour & Sound ex. Tongue feedback 11 (b) Mental Disease + Epilepsy Pulse feedback 21 (c) 18 Auricular Acupuncture (d) Intro. to Guasha + practice Cupping, moxa practice Tongue feedback 14 (2) I cannot see where the students are taught about research methods and statistics. I would like to see Lecture handouts/notes and PowerPoint presentations for teaching in this area, but the ‘timetables’ that you sent don’t make clear when or if it is taught. The BSc Acupuncture is delivered by a partner college, the College of Integrated Chinese Medicine (CICM), with Kingston University providing validation only. As such, the University does not hold copies of the teaching materials used on this course. In order to obtain copies of the teaching materials required you may wish to contact the College of Integrated Chinese Medicine directly. This completes the University’s response to your information request.

So again we see that Kingston has validated the course but has not seen a timetable, far less what is taught.  My reply was thus

 Yes I am exceedingly unhappy about it.  The university attaches its name to the course so it must obviously be able to get the material simply by asking for it (I’m surprised that the university should endorse a course without knowing what is taught on it, but that’s another matter). I request formally that you obtain this material.  If necessary please read this as a formal appeal.

I await with interest. In every single case so far, the internal review has merely confirmed the initial refusal.  It means a bit of a delay before the case goes to the Information Commisssioner’s Office.

Napier University Edinburgh

Napier University runs a "BSc (Hons) Herbal medicine". (brochure here).  Since herbal medicine is a subject of the Pittilo recommendations, there is enormous public interest in what they teach. So I asked, under the Freedom of Information (Scotland) Act (2002).  They sent quite quickly validation and accreditation documents, some examination papers, timetables and lecture lists.

The validation was the usual vacuous box-ticking stuff though it did reveal that the course “made extensive use of techniques such as tongue and pulse diagnosis”, which are well known phoney diagnosis methods, about as much use as a pendulum (as used at Westminster University).

As at Kingston University, the exam papers they chose to send were mostly "pretend doctor" stuff. One of them was

Discuss the herbal practitioner’s role in the management of IHD [ischaemic heart disease)

How one would like to see what the students said, and, even more one would like to see the model answer.  Amateurs who try to treat potentially serious conditions are a danger to the public.

So then we got to the interesting bit, the request for actual teaching materials.

 I have looked at the material that you sent and I’d now like to make the following supplementary request (A) Lecture notes/handouts and powerpoint slides for the following small smaple of lectures HRB09102 Materia Medica 4 (1) Zingiber officinalis, Eleutherococcus senticosus, Valeriana officinalis (2) Gelsemium sempervirens, Cimicifuga racemosa, Datura stramonium, Piscidia erythrina (3) Betula pendula, Capsella bursa-pastoris, Ephedra sinica, Solidago virgaurea Materia Medica 3 HRB08103 (1) Cardiovascular system (2) Nervous system Clinical Medicine and Diagnosis 4 (HRB09104) (1) Neuro-sensory deficits, paraesthesiae, head pain HRB09100 Materia Medica & Herbal Practice Week 7  Compiling a therapeutic plan and prescription building BSc Herbal Medicine : Materia Medica HRB07102 Week 3   History of Herbal Medicine Gothean tasting session Week 10  Energetics  the basic concepts Ayurveda Lastly, I can see nowhere in the timetable, lectures that deal with Research methods, clinical trial design and statistics. If such lectures exist, please send notes and powerpoints for them too

No prizes for guessing the result   Total refusal to send any of them.  To make matters worse, the main grounds for refusal were the very "commercial interests" which, after careful legal examination, the Information Commissioner (for England and Wales) had decided were invalid.  They say too that "The public interest in withholding the information is greater than the public interest in its release".. It is hard to see how the public interest is served by concealing from the people who pay for the degrees what is taught on degrees that Pittilo wants to make compulsory. [Download the whole response]

The matter is now under internal appeal (read the appeal) and eventually we shall find out whether the Scottish Information Commissioner backs the judgement.

Robert Gordon University Aberdeen

This case has particular interest because the Vice-Chancellor of Robert Gordon University is Professor Michael Pittilo, chair of the highly contentious steering group that recommended degress in CAM.  Robert Gordon University (RGU) does not teach herbal medicine or acupuncture. But they do run An Introduction to Homeopathy. All the degrees in homeopathy have closed. It is perhaps the daftest and most discredited of all the popular forms of Magic Medicine.  But Professor Pittilo thinks it is an appropriate subject to teach in his university.

So again I asked for information under the Freedom of Information (Scotland) Act 2002. They sent me quite quckly a list of the powerpoint presentations used on the courses [download it]. I asked for a small sample of the powerpoints.  And again the university did not possess them!

 I should like to see only the following three powerpoint presentations in the first instance, please. Please can you let me know also who produced the powerpoints. (1) Evidence for homeopathy (2) First aid remedies (3) Allergies I note that you will have to request them but since they are being offered as part of a course offered by RGU, so RGU is responsible for their quality, I presume that this should cause no problem.

The request was refused on much the same grounds as used by Napier University.  As usual, the internal review just confirmed the initial proposal (but dropped the obviously ludicrous public interest defence).  The internal review said

“it is mainly the quality of our courses (including course material) and teaching which has given us the position of "the best modern university in Scotland"

I am bound to ask, if the university is so proud of its course material, why is it expending so much time and money to prevent anyone from seeing a small sample of it?

My appeal has been sent to the Scottish Information Commissioner [download the appeal].

I find it very difficult to imagine what is going through the heads of vice-chancellors who run courses in mumbo-jumbo.   Most of them don’t believe a word of it (though Michael Pittilo might be an exception) yet they foist it on their students. How do they sleep at night?

Recently the excellent Joe Collier wrote a nice BMJ blog which applauded the lack of respect for authority in today’s students, Joe Collier says good riddance to old-fashioned respect. I couldn’t resist leaving a comment.

 I couldn’t agree more. There is nothing quite so unnerving as being addressed as “Sir”. It is an advantage of age that you realise what second-rate people come to occupy very grand positions. Still odder since, if occasionally they are removed for incompetence, they usually move to an even grander position. I guess that when I was an undergraduate, I found vice-chancellors somewhat imposing. That is, by and large, not a view that survives closer acquaintance.

Should teaching materials be open to the public?

There is only one university in the world that has, as a matter of policy, made all of its teaching material open to the public,  that is the Massachusetts Institute of Technology (MIT).  I can recommend strongly course 18.06, a wonderful set of lectures on Linear Algebra by Gilbert Strang.  (It is also a wonderful demonstration of why blackboards may be better than Powerpoint for subjects like this). Now they are on YouTube too.

A lot of other places have made small moves in the same direction, as discussed recently in Times Higher Education, Get it Out in the Open

Now the OU is working with other British universities to help them develop and share open course materials. In June, at the celebrations for the 40th anniversary of the OU, Gordon Brown announced funding to establish the Support Centre for Open Resources in Education at the OU, as part of a £7.8 million grant designed to enhance the university’s national role.

The funding follows a separate grant of £5.7 million from the Higher Education Funding Council for England for universities across the sector to make thousands of hours of free learning materials available.

Much material is available on the web, when individual teachers choose to place it there, but at the same time there is a move in the other direction. In particular, the widespread adoption of Moodle has resulted in a big decrease in openness. Usually you have to be registered on a course to see the material. Even other people in the university can’t see it. I think that is a deplorable development (so, presumably, does HEFCE).

Conclusion

I was told by the Univerity of Kingston that

“The course is one which the University has validated and continues to be subject to the University’s quality assurance procedures, such as internal subject reviews, annual monitoring and external examining”

The only conclusion to be drawn from this is that “quality arrurance procedures” work about as well in universities as they did in the case of baby Peter. No doubt they were introduced with worthy aims. But in practice they occupy vast amounts of time for armies of bureaucrats, and because the brain does not need to be engaged they end up endorsing utter nonsenes. The system is broken.

Resistance is futile.  You can see a lot of the stuff here

It is hard to keep secrets in the internet age. Thanks to many wonderful people who have sent me material. you can see plenty of what is taught, despite the desperate attempts of vice-chancellors to conceal it.  Try these links.

What is actually taught

Chinese medicine -acupuncture gobbledygook revealed
http://www.dcscience.net/?p=1950

Consultation opens on the Pittilo report: help top stop the Department of Health making a fool of itself
http://www.dcscience.net/?p=2007

Why degrees in Chinese medicine are a danger to patients
http://www.dcscience.net/?p=2043

More make-believe from the University of Westminster. This time its Naturopathy
http://www.dcscience.net/?p=1812

The last BSc (Hons) Homeopathy closes! But look at what they still teach at Westminster University.
http://www.dcscience.net/?p=1329

The opposite of science
http://www.dcscience.net/?p=1191

Bad medicine. Barts sinks further into the endarkenment.
http://www.dcscience.net/?p=1143

A letter to the Times, and progress at Westminster
http://www.dcscience.net/?p=984

Nutritional Fairy Tales from Thames Valley University
http://www.dcscience.net/?p=260

Westminster University BSc: amethysts emit high yin energy
http://www.dcscience.net/?p=227

References for Pittilo report consultation

A very bad report: gamma minus for the vice-chancellor
http://www.dcscience.net/?p=235

The Times (blame subeditor for the horrid title)
http://www.timesonline.co.uk/tol/comment/columnists/guest_contributors/article4628938.ece

Some follow up on the Times piece
http://www.dcscience.net/?p=251

The Health Professions Council breaks its own rules: the result is nonsense
http://www.dcscience.net/?p=1284

One month to stop the Department of Health endorsing quackery.  The Pittilo questionnaire,
http://www.dcscience.net/?p=2310

An excellent submission to the consultation on statutory regulation of alternative medicine (Pittilo report)
http://www.dcscience.net/?p=2329

Follow-up

Two weeks left to stop the Department of Health making a fool of itself. Email your response to tne Pittilo consultation to this email address HRDListening@dh.gsi.gov.uk

I’ve had permission to post a submission that has been sent to the Pittilo consultation. The whole document can be downloaded here. I have removed the name of the author. It is written by the person who has made some excellent contributions to this blog under the pseudonym "Allo V Psycho".

The document is a model of clarity, and it ends with constructive suggestions for forms of regulation that will, unlike the Pittilo proposals, really protect patients

Here is the summary. The full document explains each point in detail.

The first two recommendations for effective regulation are much the same as mine, but the the third one is interesting. The problem with the Cancer Act (1939), and with the Unfair Trading regulations, is that they are applied very erratically. They are the responsibility of local Trading Standards offices, who have, as a rule, neither the expertise nor the time to enforce them effectively. A Health Advertising Standards Authority could perhaps take over the role of enforcing existing laws. But it should be an authority with teeth. It should have the ability to prosecute. The existing Advertising Standards Authority produces, on the whole, excellent judgements but it is quite ineffective because it can do very little.

A letter from an acupuncturist

I had a remarkable letter recently from someone who actually practises acupuncture. Here are some extracts.

 “I very much enjoy reading your Improbable Science blog. It’s great to see good old-fashioned logic being applied incisively to the murk and spin that passes for government “thinking” these days.” “It’s interesting that the British Acupuncture Council are in favour of statutory regulation. The reason is, as you have pointed out, that this will confer a respectability on them, and will be used as a lever to try to get NHS funding for acupuncture. Indeed, the BAcC’s mission statement includes a line “To contribute to the development of healthcare policy both now and in the future”, which is a huge joke when they clearly haven’t got the remotest idea about the issues involved.” “Before anything is decided on statutory regulation, the British Acupuncture Council is trying to get a Royal Charter. If this is achieved, it will be seen as a significant boost to their respectability and, by implication, the validity of state-funded acupuncture. The argument will be that if Physios and O.T.s are Chartered and safe to work in the NHS, then why should Chartered Acupuncturists be treated differently? A postal vote of 2,700 BAcC members is under-way now and they are being urged to vote “yes”. The fact that the Privy Council are even considering it, is surprising when the BAcC does not even meet the requirement that the institution should have a minimum of 5000 members (http://www.privy-council.org.uk/output/Page45.asp). Chartered status is seen as a significant stepping-stone in strengthening their negotiating hand in the run-up to statutory regulation.” “Whatever the efficacy of acupuncture, I would hate to see scarce NHS resources spent on well-meaning, but frequently gormless acupuncturists when there’s no money for the increasing costs of medical technology or proven life-saving pharmaceuticals.” “The fact that universities are handing out a science degree in acupuncture is a testament to how devalued tertiary education has become since my day. An acupuncture degree cannot be called “scientific” in any normal sense of the term. The truth is that most acupuncturists have a poor understanding of the form of TCM taught in P.R.China, and hang on to a confused grasp of oriental concepts mixed in with a bit of New Age philosophy and trendy nutritional/life-coach advice that you see trotted out by journalists in the women’s weeklies. This casual eclectic approach is accompanied by a complete lack of intellectual rigour. My view is that acupuncturists might help people who have not been helped by NHS interventions, but, in my experience, it has very little to do with the application of a proven set of clinical principles (alternative or otherwise). Some patients experience remission of symptoms and I’m sure that is, in part, bound up with the psychosomatic effects of good listening, and non-judgemental kindness. In that respect, the woolly-minded thinking of most traditional acupuncturists doesn’t really matter, they’re relatively harmless and well-meaning, a bit like hair-dressers. But just because you trust your hairdresser, it doesn’t mean hairdressers deserve the Privy Council’s Royal Charter or that they need to be regulated by the government because their clients are somehow supposedly “vulnerable”.”

Earlier postings on the Pittilo recommendations

A very bad report: gamma minus for the vice-chancellor http://www.dcscience.net/?p=235

Article in The Times (blame subeditor for the horrid title)
http://www.timesonline.co.uk/tol/comment/columnists/guest_contributors/article4628938.ece

Some follow up on The Times piece
http://www.dcscience.net/?p=251

The Health Professions Council breaks its own rules: the result is nonsense
http://www.dcscience.net/?p=1284

Chinese medicine -acupuncture gobbledygook revealed
http://www.dcscience.net/?p=1950

Consultation opens on the Pittilo report: help top stop the Department of Health making a fool of itself  http://www.dcscience.net/?p=2007

Why degrees in Chinese medicine are a danger to patients  http://www.dcscience.net/?p=2043

One month to stop the Department of Health endorsing quackery.  The Pittilo questionnaire, http://www.dcscience.net/?p=2310

Follow-up

First the MHRA lets down the public by allowing deceptive labelling of sugar pills (see here, and this this blog). Now it is the turn of NICE to betray its own principles.

The National Institute for Health and Clinical Excellence (NICE) describes its job thus

“NICE is an independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health.”

Its Guidance document on Low Back Pain will be published on Wednesday 27 May 2009, but the newspapers have already started to comment, presumably on the assumption that it will have changed little from the Draft Guidance of September 2008. These comments may have to be changed as soon as the final version becomes available.

The draft guidance, though mostly sensible, has two recommendations that I believe to be wrong and dangerous. The recommendations include (page 7) these three.

• Consider offering a course of manual therapy including spinal manipulation of up to 9 sessions over up to 12 weeks.
• Consider offering a course of acupuncture needling comprising up to 10 sessions over a period of up to 12 weeks.
• Consider offering a structured exercise programme tailored to the individual.

All three of this options are accompanied by a footnote that reads thus.

“A choice of any of these therapies may be offered, taking into account patient preference.”

On the face if it, this might seem quite reasonable. All three choices seem to be about as effective (or ineffective) as each other, so why not let patients choose between them?

Actually there are very good reasons, but NICE does not seem to have thought about them. In the past I have had a high opinion of NICE but it seems that even they are now getting bogged down in the morass of political correctness and officialdom that is the curse of the Department of Health. It is yet another example of DC’s rule number one.

Never trust anyone who uses the word ‘stakeholder’.

They do use it, often.

So what is so wrong?

For a start, I take it that the reference to “spinal manipulation” in the first recommendation is a rather cowardly allusion to chiropractic. Why not say so, if that’s whar you mean? Chiropractic is mentioned in the rest of the report but the word doesn’t seem to occur in the recommendations. Is NICE perhaps nervous that it would reduce the credibility of the report if the word chiropractic were said out loud?

Well, they have a point, I suppose. It would.

That aside, here’s what’s wrong.

The Evidence

I take as my premise that the evidence says that no manipulative therapy has any great advantage over the others.  They are all more or less equally effective.  Perhaps I should say, more or less equally ineffective, because anyone who claims to have the answer to low back pain is clearly deluded (and I should know: nobody has fixed mine yet).  So for effectiveness there are no good grounds to choose between exercise, physiotherapy, acupuncture or chiropractic.  There is, though, an enormous cultural difference.  Acupuncture and chiropractic are firmly in the realm of alternative medicine.  They both invoke all sorts of new-age nonsense for which there isn’t the slightest good evidence. That may not poison your body, but it certainly poisons your mind.

Acupuncturists talk about about “Qi”, “meridians”, “energy flows”. The fact that “sham” and “real” acupuncture consistently come out indistinguishable is surely all the evidence one needs to dismiss such nonsense. Indeed there is a small group of medical acupuncturists who do dismiss it. Most don’t. As always in irrational subjects, acupuncture is riven by internecine strife between groups who differ in the extent of their mystical tendencies,

Chiropractors talk of “subluxations”, an entirely imaginary phenomenon (but a cause of much unnecessary exposure to X-rays). Many talk of quasi-religious things like “innate energy”. And Chiropractic is even more riven by competing factions than acupuncture. See, for example, Chiropractic wars Part 3: internecine conflict.

The bait and switch trick

This is the basic trick used by ‘alternative therapists’ to gain respectability.

There is a superb essay on it by the excellent Yale neurologist Steven Novella: The Bait and Switch of Unscientific Medicine. The trick is to offer some limited and reasonable treatment (like back manipulation for low back pain).  This, it seems, is sufficient to satisfy NICE.  But then, once you are in the showroom, you can be exposed to all sorts of other nonsense about “subluxations” or “Qi”.  Still worse, you will also be exposed to the claims of many chiropractors and acupuncturists to be able to cure all manner of conditions other than back pain.  But don’t even dare to suggest that manipulation of the spine is not a cure for colic or asthma or you may find yourself sued for defamation.  The shameful legal action of the British Chiropractic Association against Simon Singh (follow it here) led to an addition to DC’s Patients’ Guide to Magic Medicine.
(In the face of such tragic behaviour, one has to be able to laugh).

Libel: A very expensive remedy, to be used only when you have no evidence. Appeals to alternative practitioners because truth is irrelevant.

NICE seems to have fallen for the bait and switch trick, hook line and sinker.

The neglected consequences

Once again, we see the consequences of paying insufficient attention to the Dilemmas of Alternative Medicine.

The lying dilemma

If acupuncture is recommended we will have acupuncturists telling patients about utterly imaginary things like “Qi” and “meridians”. And we will have chiropractors telling them about subluxations and innate energy.  It is my opinion that these things are simply make-believe (and that is also the view of a minority of acupuncturist and chiropractors).   That means that you have to decide whether the supposed benefits of the manipulation are sufficient to counterbalance the deception of patients.

Some people might think that it was worth it (though not me).  What is unforgivable is not to consider even the question.  The NICE guidance says not a word about this dilemma.  Why not?

The training dilemma

The training dilemma is even more serious.  Once some form of alternative medicine has successfully worked the Bait and Switch trick and gained a toehold in the NHS, there will be an army of box-ticking HR zombies employed to ensure that they have been properly trained in “subluxations” or “Qi”.   There will be quangos set up to issue National Occupational Standards in “subluxations” or “Qi”. Skills for Health will issue “competences” in “subluxations” or “Qi” (actually they already do). There will be courses set up to teach about “subluxations” or “Qi”, some even in ‘universities’ (there already are).

The respectability problem

But worst of all, it will become possible for aupuncturists and chiropractors to claim that they now have official government endorsement from a prestigious evidence-based organisation like NICE for “subluxations” or “Qi”.  Of course this isn’t true.  In fact the words “subluxations” or “Qi” are not even mentioned in the draft report.  That is the root of the problem. They should have been.  But omitting stuff like that is how the Bait and Switch trick works.

Alternative medicine advocates crave, above all, respectability and acceptance.  It is sad that NICE seems to have given them more credibility and acceptance without having considered properly the secondary consequences of doing so,

How did this failure of NICE happen?

It seems to have been a combination of political correctness, failure to consider secondary consequences, and excessive influence of the people who stand to make money from the acceptance of alternative medicine.

Take, for example, the opinion of the British Pain Society. This organisation encompasses not just doctors. It
includes
“doctors, nurses, physiotherapists, scientists, psychologists, occupational therapists and other healthcare professionals actively engaged in the diagnosis and treatment of pain and in pain research for the benefit of patients”. Nevertheless, their response to the draft guidelines pointed out that the manipulative therapies as a whole were over-represented.

 Manipulation The guidelines assess 9 large groups of interventions of which manual therapies are only one part. The full GDG members panel of 13 individuals included two proponents of spinal manipulation/mobilisation (P Dixon and S Vogel). In addition, the chair of the panel (M Underwood) is the lead author of the UKBEAM trial on which the positive recommendation for manipulation/mobilisation seems to predominately rest. Proponents of spinal manipulation/mobilisation were therefore over-represented in the generation of these guidelines, which, in turn could have generated the over-optimistic conclusion regarding this intervention.

It seems that the Pain Society were quite right.

LBC 97.3 Breakfast Show (25 May 2009) had a quick discussion on acupuncture (play mp3 file). After I had my say, the other side was put by Rosey Grandage. She has (among other jobs) a private acupuncture practice so she is not quite as unbiassed as me).  As usual, she  misrepresents the evidence by failing to distinguish between blind and non-blind studies. She also misrepresented what I said by implying that I was advocating drugs. That was not my point and I did not mention drugs (they, like all treatments, have pretty limited effectiveness, and they have side effects too). She said “there is very good evidence to show they (‘Qi’ and ‘meridians’] exist”.  That is simply untrue.

There can’t be a better demonstration of the consequences of falling for bait and switch than the defence mounted by Rosey Grandage. NICE may not mention “Qi” and “meridians”; but the people they want to allow into the NHS have no such compunctions.

I first came across Rosey Grandage when I discovered her contribution to the Open University/BBC course K221. That has been dealt with elsewhere.  A lot more information about acupuncture has appeared since then.  She doesn’t seem to have noticed it.  Has she not seen the Nordic Cochrane Centre report? Nor read Barker Bausell, or Singh & Ernst?  Has she any interest in evidence that might reduce her income?  Probably not.

Where to find out more

An excellent review of chiropractic can be found at the Layscience site. It was written by the indefatigable ‘Blue Wode’ who has provided enormous amounts of information at the admirable ebm-first site (I am authorised to reveal that ‘Blue Wode’ is the author of that site). There you will also find much fascinating information about both acupuncture and about chiropractic.
I’m grateful to ‘Blue Wode’ for some of the references used here.

Follow-up

The Health Professions Council (HPC) is yet another regulatory quango.

 The HPC’s strapline is “Working with health professionals to protect the public”

At present the HPC regulates; Arts therapists, biomedical scientists, chiropodists/podiatrists, clinical scientists, dietitians, occupational therapists, operating department practitioners, orthoptists, paramedics, physiotherapists, prosthetists/orthotists, radiographers and speech & language therapists.

These are thirteen very respectable jobs. With the possible exception of art therapists, nobody would doubt for a moment that they are scientific jobs, based on evidence. Dietitians, for example, are the real experts on nutrition (in contrast to “nutritional therapists” and the like, who are part of the alternative industry).  That is just as well because the ten criteria for registration with the HPC say that aspirant groups must have

“Practise based on evidence of efficacy”

But then came the Pittilo report, about which I wrote a commentary in the Times, and here, A very bad report: gamma minus for the vice-chancellor, and here.

Both the Pittilo report, the HPC, and indeed the Department of Health itself (watch this space), seem quite unable to grasp the obvious fact that you cannot come up with any sensible form of regulation until after you have decided whether the ‘therapy’ works or whether it is so much nonsense.

In no sense can “the public be protected” by setting educational standards for nonsense.  But this obvioua fact seems to be beyond the intellectual grasp of the quangoid box-ticking mentality.

That report recommended that the HPC should regulate also Medical Herbalists, Acupuncturists and Traditional Chinese Medicine Practitioners. Even more absurdly, it recommended degrees in these subjects, just at the moment that those universities who run them are beginning to realise that they are anti-scientific subjects and closing down degrees in them.

How could these three branches of the alternative medicine industry possibly be eligible to register with the HPC when one of the criteria for registration is that there must be “practise based on evidence of efficacy”?

Impossible, I hear you say.  But if you said that, I fear you may have underestimated the capacity of the official mind for pure double-speak.

The HPC published a report on 11 September 2008, Regulation of Medical Herbalists, Acupuncturists and Traditional Chinese Medicine Practitioners.

The report says

1. Medical herbalists, acupuncturists and traditional Chinese medicine practitioners should be statutorily regulated in the public interest and for public safety reasons.

2. The Health Professions Council is appropriate as the regulator for these professions.

3. The accepted evidence of efficacy overall for these professions is limited, but regulation should proceed because it is in the public interest.

But the last conclusion contradicts directly the requirement for “practise based on evidence of efficacy”.  I was curious about how this contradiction
could be resolved so I sent a list of questions.  The full letter is here.

The letter was addressed to the president of the HPC, Anna van der Gaag, but with the customary discourtesy of such organisations, it was not answered by her but by Michael Guthrie, Head of Policy and Standards   He said

“Our Council considered the report at its meeting in July 2008 and decided that the regulation of these groups was necessary on the grounds of public protection. The Council decided to make a recommendation to the Secretary of State for Health that these groups be regulated.
http://www.hpc-uk.org/assets/documents/100023FEcouncil_20080911_enclosure07.pdf
“.

This, of course, doesn’t answer any of my questions. It does not explain how the public is protected by insisting on formal qualifications, if the qualifications
happen to teach mythical nonsense. Later the reply got into deeper water.

“I would additionally add that the new professions criteria are more focused on the process and structures of regulation, rather than the underlying rationale for regulation – the protection of members of the public. The Council considered the group’s report in light of a scoring against the criteria. The criteria on efficacy was one that was scored part met. As you have outlined in your email (and as discussed in the report itself) the evidence of efficacy (at least to western standards) is limited overall, particularly in the areas of herbal medicines and traditional Chinese medicine. However, the evidence base is growing and there was a recognition in the report that the individualised approach to practice in these areas did not lend themselves to traditional RCT research designs.”

Yes, based on process and structures (without engaging the brain it seems). Rather reminiscent of the great scandal in UK Social Services. It is right in one respect though.

The evidence base is indeed growing, But it is almost all negative evidence. Does the HPC not realise that? And what about “at least by Western standards”?   Surely the HPC is not suggesting that UK health policy should be determined by the standards of evidence of Chinese herbalists?  Actually it is doing exactly that since its assessment of evidence was based on the Pittilo report in which the evidence was assessed (very badly) by herbalists.

One despairs too about the statement that

“there was a recognition in the report that the individualised approach to practice in these areas did not lend themselves to traditional RCT research designs”

Yes of course the Pittilo report said that, because it was written by herbalists! Had the HPC bothered to read Ben Goldacre’s column in the Guardian they would have realised that there is no barrier at all to doing proper tests. It isn’t rocket science, though it seems that it is beyond the comprehension of the HPC.

So I followed the link to try again to find out why the HPC had reached the decision to breach its own rules. Page 10 of the HPC Council report says

3. The occupation must practise based on evidence of efficacy This criterion covers how a profession practises. The Council recognizes the centrality of evidence-based practice to modern health care and will assess applicant occupations for evidence that demonstrates that:

• Their practice is subject to research into its effectiveness. Suitable evidence would include publication in journals that are accepted as
learned by the health sciences and/or social care communities
• There is an established scientific and measurable basis for measuring outcomes of their practice. This is a minimum—the Council welcomes
evidence of there being a scientific basis for other aspects of practice and the body of knowledge of an applicant occupation
• It subscribes to the ethos of evidence-based practice, including being open to changing treatment strategies when the evidence is in favour
of doing so.

So that sounds fine. Except that research is rarely published in “journals that are accepted as learned by the health sciences”. And of course most of the good evidence is negative anyway. Nobody with the slightest knowledge of the literature could possibly think that these criteria are satisfied by Medical Herbalists, Acupuncturists and Traditional Chinese Medicine Practitioners.

So what does the HPC make of the evidence?  Appendix 2 tells us. It goes through the criteria for HPS registration.

“Defined body of knowledge:  There is a defined body of knowledge, although approaches to practice can vary within each area.”

There is no mention that the “body of knowledge” is, in many cases, nonsensical gobbledygook and, astonishingly this criterion was deemed to be “met”!.

This shows once again the sheer silliness of trying to apply a list of criteria without first judging whether the subject is based in reality,

Evidence of efficacy. There is limited widely accepted evidence of efficacy, although this could be partly explained by the nature of the professions in offering bespoke treatments to individual patients. This criterion is scored part met overall.

Sadly we are not told who deemed this criterion to be “part met”. But it does say that “This scoring has been undertaken based on the information outlined in the [Pittilo] report”. Since the assessment of evidence in that report was execrably bad (having been made by people who would lose their jobs if
they said anything negative). it is no wonder that the judgement is overoptimistic!
Did the HPC not notice the quality of the evidence presented in the Pittilo report?   Apparently not.  That is sheer incompetence.

Nevertheless the criterion was not “met”, so they can’t join HPC, right?   Not at all. The Council simply decided to ignore its own rules.

On page 5 of the Council’s report we see this.

The Steering Group [Pittilo] argues that a lack of evidence of efficacy should not prevent regulation but that the professions should be encouraged and funded to strengthen the evidence base (p.11, p. 32, p.34).

This question can be a controversial area and the evidence base of these professions was the focus of some press attention following the report’s publication. An often raised argument against regulation in such circumstances is that it would give credibility in the public’s eyes to treatments that are not proven to be safe or efficacious.

This second point is dead right, but it is ignored. The Council then goes on to say

In terms of the HPC’s existing processes, a lack of ‘accepted’ evidence of efficacy is not a barrier to producing standards of proficiency or making decisions about fitness to practise cases.

This strikes me as ludicrous, incompetent, and at heart, dishonest.

There will be no sense in policy in this area until the question of efficacy is referred to NICE.  Why didn’t the HPC recommend that?  Why has it not been done?

One possible reason is that I discovered recently that, although there are two scientific advisers in the Department of Health,. both of them claim that it is “not their role” to give scientific advice in this area.  So the questions get referred instead to the Prince of Wales Foundation. That is no way to run a ship.

The fact of the matter is that the HPC, like so many other regulatory agencies, fails utterly to protect the public from fraudulent and incompetent practitioners. In fact it actually protects them, in the same way that the financial ‘regulators’ protected fraudulent bankers.  They all seem to think that ticking boxes and passing exams is an effective process. Even if the exams require you to memorise that amethysts “emit high Yin energy so transmuting lower energies and clearing and aligning energy disturbance as all levels of being”.