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This is my version of a post which I was asked to write for the Independent. It’s been published, though so many changes were made by the editor that I’m posting the original here (below).

Superstition is rife in all sports. Mostly it does no harm, and it might even have a placebo effect that’s sufficient to make a difference of 0.01%. That might just get you a medal. But what does matter is that superstition has given rise to an army of charlatans who are only to willing to sell their magic medicine to athletes, most of whom are not nearly as rich as Phelps.

So much has been said about cupping during the last week
that it’s hard to say much that’s original. Yesterday I did six radio interviews and two for TV, and today Associated Press TV came to film a piece about it. Everyone else must have been on holiday. The only one I’ve checked was the piece on the BBC News channel. That one didn’t seem to go too badly, so it’s here

### BBC news coverage

It starts with the usual lengthy, but uninformative, pictures of someone being cupped, The cupper in this case was actually a chiropractor, Rizwhan Suleman. Chiropractic is, of course a totally different form of alternative medicine and its value has been totally discredited in the wake of the Simon Singh case. It’s not unusual for people to sell different therapies with conflicting beliefs. Truth is irrelevant. Once you’ve believed one impossible thing, it seems that the next ones become quite easy.

The presenter, Victoria Derbyshire, gave me a fair chance to debunk it afterwards.

Nevertheless, the programme suffered from the usual pretence that there is a controversy about the medical value of cupping. There isn’t. But despite Steve Jones’ excellent report to the BBC Trust, the media insist on giving equal time to flat-earth advocates. The report, (Review of impartiality and accuracy of the BBC’s coverage of science) was no doubt commissioned with good intentions, but it’s been largely ignored.

Still worse, the BBC News Channel, when it repeated the item (its cycle time is quite short) showed only Rizwhan Suleman and cut out my comments altogether. This is not false balance. It’s no balance whatsoever. A formal complaint has been sent. It is not the job of the BBC to provide free advertising to quacks.

After this, a friend drew my attention to a much worse programme on the subject.

The Jeremy Vine show on BBC Radio 2, at 12.00 on August 10th, 2016. This was presented by Vanessa Feltz. It was beyond appalling. There was absolutely zero attempt at balance, false or otherwise. The guest was described as being am "expert" on cupping. He was Yusef Noden, of the London Hijama Clinic, who "trained and qualified with the Hijama & Prophetic Medicine Institute". No doubt he’s a nice bloke, but he really could use a first year course in physiology. His words were pure make-believe. His repeated statements about "withdrawing toxins" are well know to be absolutely untrue. It was embarrassing to listen to. If you really want to hear it, here is an audio recording.

This programme is one of the worst cases I’ve heard of the BBC mis-educating the public by providing free advertising for quite outrageous quackery. Another complaint will be submitted. The only form of opposition was a few callers who pointed out the nonsense, mixed with callers who endorsed it. That is not, by any stretch of the imagination, fair and balanced.

It’s interesting that, although cupping is often associated with Traditional Chinese Medicine, neither of the proponents in these two shows was Chinese, but rather they were Muslim. This should not be surprising as neither cupping nor acupuncture are exclusively Chinese. Similar myths have arisen in many places. My first encounter with this particular branch of magic medicine was when I was asked to make a podcast for “Things Unseen”, in which I debated with a Muslim hijama practitioner and an Indian Ayurvedic practitioner. It’s even harder to talk sense to practitioners of magic medicine who believe that god is on their side, as well as believing that selling nonsense is a good way to make a living.

An excellent history of the complex emergence of similar myths in different parts of the world has been published by Ben Kavoussi, under the title "Acupuncture is astrology with needles".

Now the original version of my blog for the Independent.

## Cupping: Michael Phelps and Gwyneth Paltrow may be believers, but the truth behind it is what really sucks

The sight of Olympic swimmer, Michael Phelps, with bruises on his body caused by cupping resulted in something of a media feeding-frenzy this week. He’s a great athlete so cupping must be responsible for his performance, right?  Just as cupping must be responsible for the complexion of an earlier enthusiast, Gwyneth Paltrow.

The main thing in common between Phelps and Paltrow is that they both have a great deal of money, and neither has much interest in how you distinguish truth from myth.  They can afford to indulge any whim, however silly.

And cupping is pretty silly. It’s a pre-scientific medical practice that started in a time when there was no understanding of physiology, much like bloodletting. Indeed one version does involve a bit of bloodletting.  Perhaps bloodletting is the best argument against the belief that it’s ancient wisdom, so it must work. It was a standard part of medical treatment for hundreds of years, and killed countless people.

It is desperately implausible that putting suction cups on your skin would benefit anything, so it’s not surprising that there is no worthwhile empirical evidence that it does.  The Chinese version of cupping is related to acupuncture and, unlike cupping, acupuncture has been very thoroughly tested. Over 3000 trials have failed to show any benefit that’s big enough to benefit patients. Acupuncture is no more than a theatrical placebo.  And even its placebo effects are too small to be useful.

At least it’s likely that cupping usually does no lasting damage.. We don’t know for sure because in the world of alternative medicine there is no system for recording bad effects (and there is a vested interest in not reporting them).  In extreme cases, it can leave holes in your skin that pose a serious danger of infection, but most people probably end up with just broken capillaries and bruises.  Why would anyone want that?
The answer to that question seems to be a mixture of wishful thinking about the benefits and vastly exaggerated claims made by the people who sell the product.

It’s typical that the sales people can’t even agree on what the benefits are alleged to be.  If selling to athletes, the claim may be that it relieves pain, or that it aids recovery, or that it increases performance.  Exactly the same cupping methods are sold to celebs with the claim that their beauty will be improved because cupping will “boost your immune system”.  This claim is universal in the world of make-believe medicine, when the salespeople can think of nothing else. There is no surer sign of quackery.  It means nothing whatsoever.  No procedure is known to boost your immune system.  And even if anything did, it would be more likely to cause inflammation and blood clots than to help you run faster or improve your complexion.

It’s certainly most unlikely that sucking up bits of skin into evacuated jars would have any noticeable effect on blood flow in underlying muscles, and so increase your performance.  The salespeople would undoubtedly benefit from a first year physiology course.

Needless to say, they haven’t tried to actually measuring blood flow, or performance. To do that might reduce sales.  As Kate Carter said recently “Eating jam out of those jars would probably have a more significant physical impact”.

The problem with all sports medicine is that tiny effects could make a difference. When three hour endurance events end with a second or so separating the winner from the rest, that is an effect of less than 0.01%.   Such tiny effects will never be detectable experimentally.  That leaves the door open to every charlatan to sell miracle treatments that might just work.  If, like steroids, they do work, there is a good chance that they’ll harm your health in the long run.

You might be better off eating the jam.

Here is a very small selection of the many excellent accounts of cupping on the web.

There have been many good blogs. The mainstream media have, on the whole, been dire. Here are three that I like,

 In July 2016, Orac posted in ScienceBlogs. "What’s the harm? Cupping edition". He used his expertise as a surgeon to explain the appalling wounds that can be produced by excessive cupping. Photo from news,com.au

Timothy Caulfield, wrote "Olympic debunk!". He’s  Chair in Health Law and Policy at the University of Alberta, and the author of Is Gwyneth Paltrow Wrong about Everything.

“The Olympics are a wonderful celebration of athletic performance. But they have also become an international festival of sports pseudoscience. It will take an Olympic–sized effort to fight this bunk and bring a win to the side of evidence-based practice.”

Jennifer Raff wrote Pseudoscience is common among elite athletes outside of the Olympics too…and it makes me furious. She works on the genomes of modern and ancient people at the University of Kansas, and, as though that were not a full-time job for most people, she writes blogs, books and she’s also "training (and occasionally competing) in Muay Thai, boxing, BJJ, and MMA".

"I’m completely unsurprised to find that pseudoscience is common among the elite athletes competing in the Olympics. I’ve seen similar things rampant in the combat sports world as well."

What she writes makes perfect sense. Just don’t bother with the comments section which is littered with Trump-like post-factual comments from anonymous conspiracy theorists.

### Follow-up

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

It makes a nice change to be able to compliment an official government report.

 Ever since the House of Lords report in 2000, the government has been vacillating about what should be done about herbalists. At the moment both western herbalists and traditional Chinese medicine (TCM) are essentially unregulated. Many (but not all) herbalists have been pushing for statutory regulation, which they see as government endorsement. It would give them a status like the General Medical Council.

A new report has ruled out this possibility, for very good reasons [download local copy].

### Back story (abridged!)

My involvement began with the publication in 2008 of a report on the Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine . That led to my post, A very bad report: gamma minus for the vice-chancellor. The report was chaired by the late Professor Michael Pittilo BSc PhD CBiol FIBiol FIBMS FRSH FLS FRSA, Principal and Vice-Chancellor of The Robert Gordon University, Aberdeen. The membership of the group consisted entirely of quacks and the vice -chancellor’s university ran a course in homeopathy (now closed).

The Pittilo report recommended statutory regulation and "The threshold entry route to the register will normally be through a Bachelor degree with Honours". It ignored entirely the little problem that you can’t run a BSc degree in a subject that’s almost entirely devoid of evidence. It said, for example that acupuncturists must understand " yin/yang, 5 elements/phases, eight principles, cyclical rhythms, qi ,blood and body fluids". But of course there is nothing to "understand"! They are all pre-scientific myths. This “training dilemma” was pointed out in one of my earliest posts, You’d think it was obvious, but nonetheless the then Labour government seemed to take this absurd report seriously.

In 2009 a consultation was held on the Pittilo report. I and many of my friends spent a lot of time pointing out the obvious. Eventually the problem was again kicked into the long grass.

The THR scheme

Meanwhile European regulations caused the creation of the Traditional Herbal Registration (THR) scheme. It’s run by the Medicines and Healthcare products Regulatory Authority (MHRA). This makes it legal to put totally misleading claims on labels of herbal concoctions, as long as they are registered with THR, They also get an impressive-looking certification mark. All that’s needed to get THR registration is that the ‘medicines’ are not obviously toxic and they have been in use for 30 years. There is no need to supply any information whatsoever about whether they work or not. This appears to contradict directly the MHRA’s brief:

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

After much effort, I elicited an admission from the MHRA that there was no reason to think that any herbal concoctions were effective, and that there was nothing to prevent them from adding a statement to say so on the label. They just chose not to do so. That’s totally irresponsible in my opinion. See Why does the MHRA refuse to label herbal products honestly? Kent Woods and Richard Woodfield tell me. Over 300 herbal products have been registered under the THR scheme (a small percentage of the number of products being used). So far only one product of Tibetan medicine and one traditional Chinese medicine have been registered under THR. These are the only ones that can be sold legally now, because no herbs whatsoever have achieved full marketing authorisation -that requires good evidence of efficacy and that doesn’t exist for any herb.

### The current report

Eventually, in early 2014, the Tory-led government set up yet another body, "Herbal Medicines and Practitioners Working Group " (HMPWG). My heart sank when I saw its membership (Annex A.2). The vice-chair was none other that the notorious David Tredinnick MP (Con, Bosworth). It was stuffed with people who had vested interests. I wrote to the chair and to the few members with scientific credentials to put my views to them.

But my fears were unfounded, because the report of the HMPWG was not written by the group, but by its chair only. David Walker is deputy chief medical officer and he had clearly listened. Here are some quotations.

The good thing about the European laws is that

"This legislation effectively banned the importation and sale of large-scale manufactured herbal medicine products. This step severely limited the scope of some herbal practitioners to continue practising, particularly those from the Traditional Chinese Medicine (TCM) and Ayurvedic traditions."

The biggest loophole is that

"At present under UK law it is permitted for a herbal practitioner to see individual patients, offer diagnoses and prepare herbal treatments on their own premises, as long as these preparations do not contain banned or restricted substances. This is unchanged by the Traditional Herbal Medicinal Products Directive. "

Walker recognised frankly that there is essentially no good evidence that any herb, western or Chinese, works well enough to make an acceptable treatment. And importantly he, unlike Pittilo, realised that this precludes statutory regulation.

"There are a small number of studies indicating benefit from herbal medicine in a limited range of conditions but the majority of herbal medicine practice is not supported by good quality evidence. A great deal of international, primary research is of poor quality. "

"ts. Herbal medicine practice is therefore currently based upon traditional practice rather than science. It is difficult to differentiate good practice from poor practice on the basis of this evidence in a way that could establish standards for statutory regulation"

The second problem was the harms done by herbs. Herbalists, western and Chinese, have no satisfactory way of reporting side effects

" . .   . there is very limited understanding of the risks to patient safety from herbal medicines and herbal practice. A review of safety data was commissioned from HMAC as part of this review. This review identified many anecdotal reports and case studies but little systematically collected data. Most herbal medicine products have not been through the rigorous licensing process that is required of conventional pharmaceutical products to establish their safety and efficacy. Indeed, only a small proportion have even been subject to the less rigorous Traditional Herbal Registration (THR) process. "

"The anecdotal evidence of risk to patients from herbal products in the safety review highlighted the prominence of manufactured herbal medicines in the high profile serious incidents which have been reported in recent years. Many of these reports relate to harm thought to be caused by industrially manufactured herbal products which contained either dangerous herbs, the wrong constituents, toxic contaminants or adulterants. All such industrially manufactured products are now only available under European regulations if their safety is assured through MHRA licensing or THR
accreditation; and specific dangerous herbs have been banned under UK law. This has weakened the case for introduction of statutory regulation as a further safety measure. "

Then Walker identified correctly the training dilemma. Although it seems obvious, this is a big advance for a government document. Degrees that teach nonsense are not good training: they are miseducation.

"The third issue is the identification of educational standards for training practitioners and the benchmarking of standards for accrediting practitioners. With no good data on efficacy or safety, it is difficult for practitioners and patients to understand or quantify the potential benefits and risks of a proposed therapeutic intervention. Training programmes could accredit knowledge and skills in some areas including pharmacology and physiology, professional ethics and infection control but without a credible evidence base relating to the safety and effectiveness of herbal medicine it is hard to see how they could form the basis of accreditation in this field of practice.

There are a number of educational university programmes offering courses in herbal medicine although the number has declined in recent years. Some of these courses are accredited by practitioner organisations which is a potential governance risk as the accreditation may be based on benchmarks established by tradition and custom rather than science.
"

"The herbal medicine sector is in a dilemma" is Walker’s conclusion.

"Some practitioners would like to continue to practise as
they do now, with no further regulation, and accept that their practice is based on tradition and personal experience rather than empirical science. The logical consequence of adopting this form of practice is that we should take a precautionary approach in order to ensure public safety. The public should be protected through consumer legislation to prevent false claims, restricting the use of herbal products which are known to be hazardous to health"

The problem with this is, if course, is that although there is plenty of law, it’s rarely enforced : see Most alternative medicine is illegal Trading Standards very rarely enforce the Consumer Protection Regulations (2008) but Walker is too diplomatic to mention that fact.

"The herbals sector must recognise that its overall approach (including the rationale for use of products and methods of treatment, education and training, and interaction with the NHS) needs to be more science and evidence based if in order to be established as a profession on the same basis as other groups that are statutorily regulated."

### So what happens next?

In the short term nothing will happen.

The main mistake has been avoided: there wil be no statutory regulation.

The other options are (a) do nothing, or (b) go for accreditation of a voluntary register (AR) by the Professional Standards Authority for Health and Social Care (PSA). Walker ends up recommending the latter, but only after a lot more work (see pages 28-29 of report). Of particular interest is recommendation 5.

"As a first step it would be helpful for the sector organisations to develop an umbrella voluntary register that could support the development of standards and begin to collaborate on the collection of safety data and the establishment of an academic infrastructure to develop training and research. This voluntary register could in due course seek accreditation from the Professional Standards Authority for Health and Social Care (PSA)."

So it looks as though nothing will happen for a long time, and herbalists and TCM may end up with the utterly ineffectual PSA. After all, the PSA have accredited voluntary registers of homeopaths, so clearly nothing is too delusional for them. It’s very obvious that, unlike Walker, the PSA are quite happy to ignore the training dilemma.

### Omissions from the report

Good though this report is, by Department of Health standards, it omits some important points.

Endangered species and animal cruelty aren’t mentioned in the report. Traditional Chinese medicine, and its variants, are responsible for the near-extinction of rhinoceros, tiger and other species because of the superstitious belief that they have medicinal value. It’s not uncommon to find animal parts in Chinese medicines sold in the UK despite it being illegal

And the unspeakably cruel practice of farming bears to collect bile is a direct consequence of TCM.

A bile bear in a “crush cage” on Huizhou Farm, China (Wikipedia)

Statutory regulation of Chiropractors

The same arguments used in Walker’s report to deny statutory regulation of herbalism, would undoubtedly lead to denial of statutory regulation of chiropractors. The General Chiropractic Council was established in 1994, and has a status that’s the same as the General Medical Council. That was a bad mistake. The GCC has not protected the public, in fact it has acted as an advertising agency for chiropractic quackery.

Perhaps Prof. Walker should be asked to review the matter.

### Follow-up

You can also read minutes of the HMPWG meetings (and here). But, as usual, all the interesting controversies have been sanitised.

Edzard Ernst has also commented on this topic: Once again: the regulation of nonsense will generate nonsense – the case of UK herbalists.

This post is the original version of a post by Michael Vagg. It was posted at the Conversation but taken down within hours, on legal advice. Sadly, the Conversation has a track record for pusillanimous behaviour of this sort. It took minutes before the cached version reappeared on freezepage.com. I’m reposting it from there in the interests of free speech. La Trobe "university" should be ashamed that it’s prostituted itself for the sake of 15 m. La Trobe’s deputy vice-chancellor, Keith Nugent, gives a make-believe response to the resignation of Ken Harvey in a video. It is, in my opinion, truly pathetic. Update, The next day, the article was reposted at the Conversation. The changes they’d made can be seen in a compare document. The biggest change was removal of "has just decided to join the ranks of the spivs and hucksters of the vitamin industry". This seems to me to be perfectly fair comment. It should not have been censored by the Conversation. The recent memorandum of understanding signed between supplement company Swisse and La Trobe University to establish a Complementary Medicine Evidence Centre (CMEC) looks to me like the latest effort by a corporation to cloak their business interests in a veil of science. Unlike the UTS Sydney Australian Research Centre in Complementary and Integrative Medicine (ARCCIM), which at least has significant NHMRC funding, the La Trobe version will undertake “independent research” into complementary and alternative medicine (CAM) products that are made by the major (and so far only) donor to the Centre. Southern Cross University also has a very close relationship with the Blackmores brand of CAM products, due to the personal interest of Marcus Blackmore, the company Chairman. Blackmores claims to spend a lazy couple of million a year on their branded research centre. The Blackmores Research Centre studies Blackmores products. Presumably this situation (so similar to the proposed La Trobe model) is a coincidence since the research centre is providing completely “independent” research. The conflict of interest in such research centres is so laughably obvious that A/Prof Ken Harvey, a leading campaigner against shonky health products, a life member of Choice andThe Conversation contributor, has resigned his appointment at La Trobe in protest. Ken clearly points out in his letter of resignation that by accepting the money from Swisse, he believes La Trobe has unacceptably compromised its integrity. His letter cites multiple instances of non-compliance with TGA regulations by Swisse, as well as their disrespect for the regulatory process that governs corporate truth-telling in their industry.This story from last year gives a bit of background to the quixotic battle Harvey has fought against the massive coffers and unscrupulous business practices of Big Supplement. He has been more effective than the TGA itself at hindering the rampant gaming of the TGA Register of Therapeutic Goods by supplement and vitamin manufacturers. Clearly as a man of principle, he could not be expected to continue his association with a university that has a close relationship to a company with such a history of regulatory infringements. The untenability of Ken’s position is underlined by the fact that La Trobe itself republished on their website one of his TC articles about Swisse’s regulatory tapdancing only the previous year! Ken has been sued, traduced and generally railed against by a multi-billion dollar industry for the hideous crime of insisting that they tell the truth about their products and not mislead consumers. We need another hundred like him. That his own university has decided to take the money on offer from Swisse must be a bitter blow to him. It would be interesting to know whether any other universities were approached by Swisse in a similar way and had the courage to decline the offer. The infiltration of academia by privately funded CAM institutes is old news in the United States. The Science Based Medicine blog has christened the phenomenon “quackademic medicine” and written about it at some length. It seems the Australian CAM industry has no need to hide behind astroturfing organisations like the American group the Bravewell Collaborative to get its agenda attended to. Companies like Blackmores and Swisse can seemingly just offer to fund research institutes and cash-strapped tertiary institutions can’t resist. Friends of Science in Medicine and others have had a bit to say about the irresponsibility of educational institutions lending credibility to pseudoscience and how this practice damages universities’ standing as exemplars of scholarship and intellectual leaders within their communities. I can say without qualification that none of the much-maligned Big Pharma companies have their own fully-funded research centres at any university. Let alone a branded one where the studies are restricted to a single company’s products. It would be utterly unacceptable for the integrity of any university for such an outrageously conflicted institution to be given any support. What would it be like if GSK or Pfizer founded a research institute at a university and forced the researchers to only study their own products? Imagine the outrage. Imagine what a laughing stock such a research centre would be. That’s medical research in clown shoes. That’s academic credibility in a cheap suit trying to sell you steak knives. Vitamin and supplement companies will always be profitable because their sales pitch is based on psychological flaws that everyone has. Just ask the gaming, alcohol and tobacco companies. All of them are massively profitable. Sometimes their cash can even do good, but there’s always an angle by which they profit. Look at these guys up close, and the warts appear. All of them seek to improve their image by splashing money on hanging around with the glamorous, the successful, the smart and the credible. They hope that the magic dust of celebrity and academia will disguise the stench of the swamp they crawled out from. La Trobe Uni has just decided to join the ranks of the spivs and hucksters of the vitamin industry, and they will now have to live with having a research centre with the academic and professional credibility of the Ponds Institute. Sadly for La Trobe, they won’t have Ken Harvey to keep things reality-based. ### Follow-up 8 February 2014. Deputy vice-chancellor, Keith Nugent, tried to defend the university’s decision to take money from the "spivs and hucksters of the vitamin industry" in The Age. I sent the following letter to The Age. Let’s hope they publish it.  Keith Nugent, deputy vice-chancellor of La Trobe University, has offered a defence of the university’s decision to take a large amount of money from vitamin and herb company, Swisse. He justifies this by saying that we need to know whether or not the products work. Nugent seems to be unaware that we already know. There have been many good double-blind randomized trials and they have just about all shown that dosing yourself with vitamins and minerals does most people no good at all. Some have shown that high doses actually harm you. Perhaps the university should have checked what’s already known before taking the money. Perhaps Nugent is also unaware that trials with industry sponsorship tend to come out favourable to the companies’ product. For that reason, the results are treated with scepticism by the scientific community. If the research is worth doing, then it will be funded from the normal sources. There should be no need to take money from a company with a very strong financial interest in the outcome. D. Colquhoun FRS Professor of Pharmcology University College London Jump to follow-up One of my scientific heroes is Bernard Katz. The closing words of his inaugural lecture, as professor of biophysics at UCL, hang on the wall of my office as a salutory reminder to refrain from talking about ‘how the brain works’. After speaking about his discoveries about synaptic transmission, he ended thus.  "My time is up and very glad I am, because I have been leading myself right up to a domain on which I should not dare to trespass, not even in an Inaugural Lecture. This domain contains the awkward problems of mind and matter about which so much has been talked and so little can be said, and having told you of my pedestrian disposition, I hope you will give me leave to stop at this point and not to hazard any further guesses." Drawing ©Jenny Hersson-Ringskog The question of what to eat for good health is truly a topic about "which so much has been talked and so little can be said" That was emphasized yet again by an editorial in the British Medical Journal written by my favourite epidemiologist. John Ioannidis. He has been at the forefront of debunking hype. Its title is “Implausible results in human nutrition research” (BMJ, 2013;347:f6698. Get pdf ). The gist is given by the memorable statement "Almost every single nutrient imaginable has peer reviewed publications associating it with almost any outcome." and the subtitle Definitive solutions won’t come from another million observational papers or small randomized trials“. Being a bit obsessive about causality, this paper is music to my ears. The problem of causality was understood perfectly by Samuel Johnson, in 1756, and he was a lexicographer, not a scientist. Yet it’s widely ignored by epidemiologists. The problem of causality is often mentioned in the introduction to papers that describe survey data, yet by the end of the paper, it’s usually forgotten, and public health advice is issued. Ioannidis’ editorial vindicates my own views, as an amateur epidemiologist, on the results of the endless surveys of diet and health. There is nothing new about the problem. It’s been written about many times. Young & Karr (Significance, 8, 116 – 120, 2011: get pdf) said "Any claim coming from an observational study is most likely to be wrong". Out of 52 claims made in 12 observational studies, not a single one was confirmed when tested by randomised controlled trials. Another article cited by Ioannidis, "Myths, Presumptions, and Facts about Obesity" (Casazza et al , NEJM, 2013), debunks many myths, but the list of conflicts of interests declared by the authors is truly horrendous (and at least one of their conclusions has been challenged, albeit by people with funding from Kellogg’s). The frequent conflicts of interest in nutrition research make a bad situation even worse. The quotation in bold type continues thus. "On 25 October 2013, PubMed listed 291 papers with the keywords “coffee OR caffeine” and 741 with “soy,” many of which referred to associations. In this literature of epidemic proportions, how many results are correct? Many findings are entirely implausible. Relative risks that suggest we can halve the burden of cancer with just a couple of servings a day of a single nutrient still circulate widely in peer reviewed journals. However, on the basis of dozens of randomized trials, single nutrients are unlikely to have relative risks less than 0.90 for major clinical outcomes when extreme tertiles of population intake are compared—most are greater than 0.95. For overall mortality, relative risks are typically greater than 0.995, if not entirely null. The respective absolute risk differences would be trivial. Observational studies and even randomized trials of single nutrients seem hopeless, with rare exceptions. Even minimal confounding or other biases create noise that exceeds any genuine effect. Big datasets just confer spurious precision status to noise." And, later, "According to the latest burden of disease study, 26% of deaths and 14% of disability adjusted life years in the United States are attributed to dietary risk factors, even without counting the impact of obesity. No other risk factor comes anywhere close to diet in these calculations (not even tobacco and physical inactivity). I suspect this is yet another implausible result. It builds on risk estimates from the same data of largely implausible nutritional studies discussed above. Moreover, socioeconomic factors are not considered at all, although they may be at the root of health problems. Poor diet may partly be a correlate or one of several paths through which social factors operate on health." Another field that is notorious for producing false positives, wirh false attribution of causality, is the detection of biomarkers. A critical discussion can be found in the paper by Broadhurst & Kell (2006), "False discoveries in metabolomics and related experiments". "Since the early days of transcriptome analysis (Golub et al., 1999), many workers have looked to detect different gene expression in cancerous versus normal tissues. Partly because of the expense of transcriptomics (and the inherent noise in such data (Schena, 2000; Tu et al., 2002; Cui and Churchill, 2003; Liang and Kelemen, 2006)), the numbers of samples and their replicates is often small while the number of candidate genes is typically in the thousands. Given the above, there is clearly a great danger that most of these will not in practice withstand scrutiny on deeper analysis (despite the ease with which one can create beautiful heat maps and any number of ‘just-so’ stories to explain the biological relevance of anything that is found in preliminary studies!). This turns out to be the case, and we review a recent analysis (Ein-Dor et al., 2006) of a variety of such studies." The fields of metabolomics, proteomics and transcriptomics are plagued by statistical problems (as well as being saddled with ghastly pretentious names). ### What’s to be done? Barker Bausell, in his demolition of research on acupuncture, said: [Page39] “But why should nonscientists care one iota about something as esoteric as causal inference? I believe that the answer to this question is because the making of causal inferences is part of our job description as Homo Sapiens.” The problem, of course, is that humans are very good at attributing causality when it does not exist. That has led to confusion between correlation and cause on an industrial scale, not least in attempts to work out the effects of diet on health. More than in any other field it is hard to do the RCTs that could, in principle, sort out the problem. It’s hard to allocate people at random to different diets, and even harder to make people stick to those diets for the many years that are needed. We can probably say by now that no individual food carries a large risk, or affords very much protection. The fact that we are looking for quite small effects means that even when RCTs are possible huge samples will be needed to get clear answers. Most RCTs are too short, and too small (under-powered) and that leads to overestimation of the size of effects. That’s a problem that plagues experimental pyschology too, and has led to a much-discussed crisis in reproducibility. "Supplements" of one sort and another are ubiquitous in sports. Nobody knows whether they work, and the margin between winning and losing is so tiny that it’s very doubtful whether we ever will know. We can expect irresponsible claims to continue unabated. The best thing that can be done in the short term is to stop doing large observational studies altogether. It’s now clear that inferences made from them are likely to be wrong. And, sad to say, we need to view with great skepticism anything that is funded by the food industry. And make a start on large RCTs whenever that is possible. Perhaps the hardest goal of all is to end the "publish or perish" culture which does so much to prevent the sort of long term experiments which would give the information we want. Ioannidis’ article ends with the statement "I am co-investigator in a randomized trial of a low carbohydrate versus low fat diet that is funded by the US National Institutes of Health and the non-profit Nutrition Science Initiative." It seems he is putting his money where his mouth is. Until we have the results, we shall continue to be bombarded with conflicting claims made by people who are doing their best with flawed methods, as well as by those trying to sell fad diets. Don’t believe them. The famous "5-a-day" advice that we are constantly bombarded with does no harm, but it has no sound basis. As far as I can guess, the only sound advice about healthy eating for most people is • don’t eat too much • don’t eat all the same thing You can’t make much money out of that advice. No doubt that is why you don’t hear it very often. ### Follow-up Two relevant papers that show the unreliability of observational studies, "Nearly 80,000 observational studies were published in the decade 1990–2000 (Naik 2012). In the following decade, the number of studies grew to more than 260,000". Madigan et al. (2014) “. . . the majority of observational studies would declare statistical significance when no effect is present” Schuemie et al., (2012) 20 March 2014 On 20 March 2014, I gave a talk on this topic at the Cambridge Science Festival (more here). After the event my host, Yvonne Noblis, sent me some (doubtless cherry-picked) feedback she’d had about the talk. Jump to follow-up 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., hardcover26.99 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.

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

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

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

### Acupuncture is a theatrical placebo

David Colquhoun (UCL) and Steven Novella (Yale)

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

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

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

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

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

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

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

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

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

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

Three things that are not relevant to the argument

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

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

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

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

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

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

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

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

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

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

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

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

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

Specific conditions

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

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

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

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

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

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

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

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

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

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

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

Conclusions

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

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

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

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

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

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

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

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Arch Intern Med. 2007;167:1892–8 10. Witt C, Brinkhaus B, Jena S, Linde K, Streng A, Wagenpfeil S, Hummelsberger J, Walther HU, Melchart D, Willich SN. Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet. 2005;366:136–43 11. Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med. 2009;169:858–66 12. Madsen MV, Gøtzsche PC, Hróbjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ. 2009;338:a3115 13. Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009;146:238–44 14. Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012;172:1444–53 15. Paterson C, Taylor RS, Griffiths P, Britten N, Rugg S, Bridges J, McCallum B, Kite G. Acupuncture for ‘frequent attenders’ with medically unexplained symptoms: a randomised controlled trial (CACTUS study). Br J Gen Pract. 2011;61:e295–e305 16. . Letters in response to Acupuncture for ‘frequent attenders’ with medically unexplained symptoms. Br J Gen Pract. 2011;61 Available at: http://www.ingentaconnect.com/content/rcgp/bjgp/2011/00000061/00000589. Accessed March 30, 2013 17. Colquhoun D. Acupuncturists show that acupuncture doesn’t work, but conclude the opposite: journal fails. 2011 Available at: http://www.dcscience.net/?p=4439. Accessed September 2, 2012 18. Ernst E, Lee MS, Choi TY. Acupuncture: does it alleviate pain and are there serious risks? A review of reviews. Pain. 2011;152:755–64 19. Colquhoun D. NICE falls for Bait and Switch by acupuncturists and chiropractors: it has let down the public and itself. 2009 Available at: http://www.dcscience.net/?p=1516. Accessed September 2, 2012 20. Colquhoun D. The NICE fiasco, part 3. Too many vested interests, not enough honesty. 2009 Available at: http://www.dcscience.net/?p=1593. Accessed September 2, 2012 21. Bandolier. . Acupuncture for back pain—2009 update. Available at: http://www.medicine.ox.ac.uk/bandolier/booth/painpag/Chronrev/Other/acuback.html. Accessed March 30, 2013 22. Artus M, van der Windt DA, Jordan KP, Hay EM. Low back pain symptoms show a similar pattern of improvement following a wide range of primary care treatments: a systematic review of randomized clinical trials. Rheumatology (Oxford). 2010;49:2346–56 23. Wang S-M, Harris RE., Lin Y-C, Gan TJ. Acupuncture in 21st century anesthesia: is there a needle in the haystack? Anesth Analg. 2013;116:1356–9 24. Lee A, Done ML. The use of nonpharmacologic techniques to prevent postoperative nausea and vomiting: a meta-analysis. Anesth Analg. 1999;88:1362–9 25. Lee A, Done ML. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2004:CD003281 26. Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2009:CD003281 27. Carlisle JB. A meta-analysis of prevention of postoperative nausea and vomiting: randomised controlled trials by Fujii etal. compared with other authors. Anaesthesia. 2012;67:1076–90 28. Sumikawa K. The results of investigation into Dr.Yoshitaka Fujii’s papers. Report of the Japanese Society of Anesthesiologists Special Investigation Committee. http://www.anesth.or.jp/english/pdf/news20120629.pdf 29. Bandolier. . Metoclopramide is ineffective in preventing postoperative nausea and vomiting. 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### Follow-up

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

26 December 2013

Over christmas the flow of stuff that misrepresents the "thousands of years" of Chinese medicine has continued unabated. Of course one expects people who are selling Chinese herbs and acupuncture to lie. All businesses do. One does not expect such misrepresentation from British Columbia, Cardiff University School of medicine, or from Yale University. I left a comment on the Yale piece. Whether it passes moderation remains to be seen. Just in case, here it is.

One statement is undoubtedly baseless ““If it’s still in use after a thousand years there must be something right,” It’s pretty obvious to the most casual observer that many beliefs that have been round for a thousand years have proved to be utterly wrong.

In any case, it’s simply not true that most “Traditional” Chinese medicine has been around for thousands of years. Acupuncture was actually banned by the Emperor Dao Guang in 1822. The sort of Chinese medicine that is sold (very profitably) to the west was essentially dead in China until it was revived by Mao as part of the great proletarian cultural revolution (largely to stir up Chinese nationalism at that time). Of course he didn’t use it himself.

This history has been documented in detail now, and it surprises me to see it misrepresented, yet again, from a Yale academic.

Of course there might turn out to be therapeutically useful chemicals in Chinese herbs (it has happened with artemesinin). But it is totally irresponsible to pretend that great things are coming in the absence of good RCTs in human patients.

Yale should be ashamed of PR like this. And so should Cardiff University. It not only makes the universities look silly. It corrupts the whole of the rest of these institutions. Who knows how much more of their PR is mere puffery.

18 January 2014. I checked the Yale posting and found that the comment, above, had indeed been deleted. There is little point in having comments if you are going to delete anything that’s mildly critical. It is simply dishonest.

The Scottish Universities Medical Journal asked me to write about the regulation of alternative medicine. It’s an interesting topic and not easy to follow because of the veritable maze of more than twenty overlapping regulators and quangos which fail utterly to protect the public against health fraud. In fact they mostly promote health fraud. The paper is now published, and here is a version with embedded links (and some small updates).

We are witnessing an increasing commercialisation of medicine. It’s really taken off since the passage of the Health and Social Security Bill into law. Not only does that mean having NHS hospitals run by private companies, but it means that “any qualified provider” can bid for just about any service.  The problem lies, of course, in what you consider “qualified” to mean.  Any qualified homeopath or herbalist will, no doubt, be eligible.  University College London Hospital advertised for a spiritual healer. The "person specification" specified a "quallfication", but only HR people think that a paper qualification means that spiritual healing is anything but a delusion.

### The vocabulary of bait and switch

First, a bit of vocabulary.  Alternative medicine is a term that is used for medical treatments that don’t work (or at least haven’t been shown to work).  If they worked, they’d be called “medicine”.  The anti-malarial, artemesinin, came originally from a Chinese herb, but once it had been purified and properly tested, it was no longer alternative.  But the word alternative is not favoured by quacks.  They prefer their nostrums to be described as “complementary” –it sounds more respectable.  So CAM (complementary and alternative medicine became the politically-correct euphemism.  Now it has gone a stage further, and the euphemism in vogue with quacks at the moment is “integrated” or “integrative” medicine.  That means, very often, integrating things that don’t work with things that do.  But it sounds fashionable.  In reality it is designed to confuse politicians who ask for, say, integrated services for old people.

Put another way, the salespeople of quackery have become rather good at bait and switch. The wikepedia definition is as good as any.

Bait-and-switch is a form of fraud, most commonly used in retail sales but also applicable to other contexts. First, customers are “baited” by advertising for a product or service at a low price; second, the customers discover that the advertised good is not available and are “switched” to a costlier product.

As applied to the alternative medicine industry, the bait is usually in the form of some nice touchy-feely stuff which barely mentions the mystical nonsense. But when you’ve bought into it you get the whole panoply of nonsense. Steven Novella has written eloquently about the use of bait and switch in the USA to sell chiropractic, acupuncture, homeopathy and herbal medicine: "The bait is that CAM offers legitimate alternatives, the switch is that it primarily promotes treatments that don’t work or are at best untested and highly implausible.".

The "College of Medicine" provides a near-perfect example of bait and switch. It is the direct successor of the Prince of Wales’ Foundation for Integrated Health. The Prince’s Foundation was a consistent purveyor of dangerous medical myths. When it collapsed in 2010 because of a financial scandal, a company was formed called "The College for Integrated Health". A slide show, not meant for public consumption, said "The College represents a new strategy to take forward the vision of HRH Prince Charles". But it seems that too many people have now tumbled to the idea that "integrated", in this context, means barmpottery. Within less than a month, the new institution was renamed "The College of Medicine". That might be a deceptive name, but it’s a much better bait. That’s why I described the College as a fraud and delusion.

Not only did the directors, all of them quacks, devise a respectable sounding name, but they also succeeded in recruiting some respectable-sounding people to act as figureheads for the new organisation. The president of the College is Professor Sir Graham Catto, emeritus professor of medicine at the University of Aberdeen. Names like his make the bait sound even more plausible. He claims not to believe that homeopathy works, but seems quite happy to have a homeopathic pharmacist, Christine Glover, on the governing council of his college. At least half of the governing Council can safely be classified as quacks.

So the bait is clear. What about the switch? The first thing to notice is that the whole outfit is skewed towards private medicine: see The College of Medicine is in the pocket of Crapita Capita. The founder, and presumably the main provider of funds (they won’t say how much) is the huge outsourcing company, Capita. This is company known in Private Eye as Crapita. Their inefficiency is legendary. They are the folks who messed up the NHS computer system and the courts computer system. After swallowing large amounts of taxpayers’ money, they failed to deliver anything that worked. Their latest failure is the court translation service.. The president (Catto), the vice president (Harry Brunjes) and the CEO (Mark Ratnarajah) are all employees of Capita.

The second thing to notice is that their conferences and courses are a bizarre mixture of real medicine and pure quackery. Their 2012 conference had some very good speakers, but then it had a "herbal workshop" with Simon Mills (see a video) and David Peters (the man who tolerates dowsing as a way to diagnose which herb to give you). The other speaker was Dick Middleton, who represents the huge herbal company, Schwabe (I debated with him on BBC Breakfast), In fact the College’s Faculty of Self-care appears to resemble a marketing device for Schwabe.

### Why regulation isn’t working, and can’t work

There are various levels of regulation. The "highest" level is the statutory regulation of osteopathy and chiropractic. The General Chiropractic Council (GCC) has exactly the same legal status as the General Medical Council (GMC). This ludicrous state of affairs arose because nobody in John Major’s government had enough scientific knowledge to realise that chiropractic, and some parts of osteopathy, are pure quackery,

The problem is that organisations like the GCC function more to promote chiropractic than to regulate them. This became very obvious when the British Chiropractic Association (BCA) decided to sue Simon Singh for defamation, after he described some of their treatments as “bogus”, “without a jot of evidence”.

In order to support Singh, several bloggers assessed the "plethora of evidence" which the BCA said could be used to justify their claims. When, 15 months later, the BCA produced its "plethora" it was shown within 24 hours that the evidence was pathetic. The demolition was summarised by lawyer, David Allen Green, in The BCA’s Worst Day.

In the wake of this, over 600 complaints were made to the GCC about unjustified claims made by chiropractors, thanks in large part to heroic work by two people, Simon Perry and Allan Henness. Simon Perry’s Fishbarrel (browser plugin) allows complaints to be made quickly and easily -try it). The majority of these complaints were rejected by the GCC, apparently on the grounds that chiropractors could not be blamed because the false claims had been endorsed by the GCC itself.

My own complaint was based on phone calls to two chiropractors, I was told such nonsense as "colic is down to, er um, faulty movement patterns in the spine". But my complaint  never reached the Conduct and Competence committee because it had been judged by a preliminary investigating committee that there was no case to answer. The impression one got from this (very costly) exercise was that the GCC was there to protect chiropractors, not to protect the public.

The outcome was a disaster for chiropractors, wno emerged totally discredited. It was also a disaster for the GCC which was forced to admit that it hadn’t properly advised chiropractors about what they could and couldn’t claim. The recantation culminated in the GCC declaring, in August 2010, that the mythical "subluxation" is a "historical concept " "It is not supported by any clinical research evidence that would allow claims to be made that it is the cause of disease.". Subluxation was a product of the fevered imagination of the founder of the chiropractic cult, D.D. Palmer. It referred to an imaginary spinal lesion that he claimed to be the cause of most diseases. .Since ‘subluxation’ is the only thing that’s distinguished chiropractic from any other sort of manipulation, the admission by the GCC that it does not exist, after a century of pretending that it does, is quite an admission.

The President of the BCA himself admitted in November 2011

“The BCA sued Simon Singh personally for libel. In doing so, the BCA began one of the darkest periods in its history; one that was ultimately to cost it financially,”

As a result of all this, the deficiencies of chiropractic, and the deficiencies of its regulator were revealed, and advertisements for chiropractic are somewhat less misleading. But this change for the better was brought about entirely by the unpaid efforts of bloggers and a few journalists, and not at all by the official regulator, the GCC. which was part of the problem. not the solution. And it was certainly not helped by the organisation that is meant to regulate the GCC, the Council for Health Regulatory Excellence (CHRE) which did nothing whatsoever to stop the farce.

At the other end of the regulatory spectrum, voluntary self-regulation, is an even worse farce than the GCC. They all have grand sounding "Codes of Practice" which, in practice, the ignore totally.

The Society of Homeopaths is just a joke. When homeopaths were caught out recommending sugar pills for prevention of malaria, they did nothing (arguably such homicidal advice deserves a jail sentence).

The Complementary and Natural Healthcare Council (CNHC) is widely know in the blogosphere as Ofquack. I know about them from the inside, having been a member of their Conduct and Competence Committee, It was set up with the help of a £900,000 grant from the Department of Health to the Prince of Wales, to oversee voluntary self-regulation. It fails utterly to do anything useful.. The CNHC code of practice, paragraph 15 , states

When Simon Perry made a complaint to the CNHC about claims being made by a CNHC-registered reflexologist, the Investigating Committee upheld all 15 complaints.  But it then went on to say that there was no case to answer because the unjustified claims were what the person had been taught, and were made in good faith.
This is precisely the ludicrous situation which will occur again and again if reflexologists (and many other alternative therapies) are “accredited”.  The CNHC said, correctly, that the reflexologist had been taught things that were not true, but then did nothing whatsoever about it apart from toning down the advertisements a bit. They still register reflexologists who make outrageously false claims.

Once again we see that no sensible regulation is possible for subjects that are pure make-believe.

The first two examples deal (or rather, fail to deal) with regulation of outright quackery. But there are dozens of other quangos that sound a lot more respectable.

European Food Standards Agency (EFSA). One of the common scams is to have have your favourite quack treatment classified as a food not as a medicine. The laws about what you can claim have been a lot laxer for foods. But the EFSA has done a pretty good job in stopping unjustified claims for health benefits from foods. Dozens of claims made by makers of probiotics have been banned. The food industry, needless to say, objects very strongly to be being forced to tell the truth. In my view, the ESFA has not gone far enough. They recently issued a directive about claims that could legally be made. Some of these betray the previously high standards of the EFSA. For example you are allowed to say that "Vitamin C contributes to the reduction of tiredness and fatigue" (as long as the product contains above a specified amount of Vitamin C. I’m not aware of any trials that show vitamin C has the slightest effect on tiredness or fatigue, Although these laws do not come into effect until December 2012, they have already been invoked by the ASA has a reason not to uphold a complaint about a multivitamin pill which claimed that it “Includes 8 nutrients that can contribute to the reduction in tiredness and fatigue”

The Advertising Standards Authority (ASA). This is almost the only organisation that has done a good job on false health claims. Their Guidance on Health Therapies & Evidence says

"Whether you use the words ‘treatment’, ‘treat’ or ‘cure’, all are likely to be seen by members of the public as claims to alleviate effectively a condition or symptom. We would advise that they are not used"

"Before and after’ studies with little or no control, studies without human subjects, self-assessment studies and anecdotal evidence are unlikely to be considered acceptable"

"Before and after’ studies with little or no control, studies without human subjects, self-assessment studies and anecdotal evidence are unlikely to be considered acceptable"

They are spot on.

The ASA’s Guidance for Advertisers of Homeopathic Services is wonderful.

"In the simplest terms, you should avoid using efficacy claims, whether implied or direct,"

"To date, the ASA has have not seen persuasive evidence to support claims that homeopathy can treat, cure or relieve specific conditions or symptoms."

That seems to condemn the (mis)labelling allowed by the MHRA as breaking the rules.. Sadly, though, the ASA has no powers to enforce its decisions and only too often they are ignored. The Nightingale collaboration has produced an excellent letter that you can hand to any pharmacist who breaks the rules

The ASA has also judged against claims made by "Craniosacral therapists" (that’s the lunatic fringe of osteopathy). They will presumably uphold complaints about similar claims made (I’m ashamed to say) by UCLH Hospitals.

The private examination company Edexcel sets exams in antiscientific subjects, so miseducating children. The teaching of quackery to 16 year-olds has been approved by a maze of quangos, none  of which will take responsibility, or justify their actions. So far I’ve located no fewer than eight of them. The Office of the Qualifications and Examinations Regulator (OfQual), Edexcel, the Qualifications and Curriculum Authority (QCA), Skills for Health, Skills for Care, National Occupational Standards (NOS), private exam company VTCT and the schools inspectorate, Ofsted.. Asking any of these people why they approve of examinations in imaginary subjects meets with blank incomprehension. They fail totally to protect tha public from utter nonsense.

The Department of Education has failed to do anything about the miseducation of children in quackery. In fact it has encouraged it by, for the first time, giving taxpayers’ money to a Steiner (Waldorf) school (at Frome, in Somerset). Steiner schools are run by a secretive and cult-like body of people (read about it). They teach about reincarnation, karma, gnomes, and all manner of nonsense, sometimes with unpleasant racial overtones. The teachers are trained in Steiner’s Anthroposophy, so if your child gets ill at school they’ll probably get homeopathic sugar pills. They might well get measles or mumps too, since Steiner people don’t believe in vaccination.

Incredibly, the University of Aberdeen came perilously close to appointing a chair in anthroposophical medicine. This disaster was aborted by bloggers, and a last minute intervention from journalists. Neither the university’s regulatory mechanisms. nor any others, seemed to realise that a chair in mystical barmpottery was a bad idea.

It is the statutory duty of Trading Standards to enforce the Consumer Protection Regulations (2008) This European legislation is pretty good. it caused a lawyer to write " Has The UK Quietly Outlawed “Alternative” Medicine?". Unfortunately Trading Standards people have consistently refused to enforce these laws. The whole organisation is a mess. Its local office arrangement fails totally to deal with the age of the internet. The situation is so bad that a group of us decided to put them to the test. The results were published in the Medico-Legal Journal, Rose et al., 2012. "Spurious Claims for Health-care Products: An Experimental Approach to Evaluating Current UK Legislation and its Implementation". They concluded "EU directive 2005/29/EC is
largely ineffective in preventing misleading health claims for consumer products in
the UK"

Skills for Health is an enormous quango which produces HR style "competences" for everything under the son. They are mostly quite useless. But those concerned with alternative medicine are not just useless. They are positively harmful. Totally barmy. There are competences and National Occupational Standards for every lunatic made-up therapy under the sun. When I phoned them to discover who’d written them, I learned that the had been drafted by the Prince of Wales’ Foundation for Magic Medicine. And when I joked by asking if they had a competence for talking to trees, I was told, perfectly seriously, “You’d have to talk to LANTRA, the land-based organisation for that.”

That was in January 2008. A lot of correspondence with the head of Skills for Health got nowhere at all. She understood nothing and it hasn’t improved a jot.

This organisation costs a lot of taxpayers’ money and it should have been consigned to the "bonfire of the quangos" (but of course there was no such bonfire in reality). It is a disgrace.

The Quality Assurance Agency (QAA) is supposed to ensure the quality of university courses. In fact it endorses courses in nonsense alternative medicine and so does more harm than good. The worst recent failure of the QAA was in the case of the University of Wales: see Scandal of the University of Wales and the Quality Assurance Agency. The university was making money by validating thousands of external degrees in everything from fundamentalist theology to Chinese Medicine. These validations were revealed as utterly incompetent by bloggers, and later by BBC Wales journalist Ciaran Jenkins (now working for Channel 4).

The mainstream media eventually caught up with bloggers. In 2010, BBC1 TV (Wales) produced an excellent TV programme that exposed the enormous degree validation scam run by the University of Wales. The programme can be seen on YouTube (Part 1, and Part 2). The programme also exposed, incidentally, the uselessness of the Quality Assurance Agency (QAA) which did nothing until the scam was exposed by TV and blogs. Eventually the QAA sent nine people to Malaysia to investigate a dodgy college that had been revealed by the BBC. The trip cost £91,000. It could have been done for nothing if anyone at the QAA knew how to use Google.

The outcome was that the University of Wales stopped endorsing external courses, and it was soon shut down altogether (though bafflingly, its vice-chancellor, Marc Clement was promoted). The credit for this lies entirely with bloggers and the BBC. The QAA did nothing to help until the very last moment.

Throughout this saga Universities UK (UUK), has maintained its usual total passivity. They have done nothing whatsoever about their members who give BSc degrees in anti-scientific subjects. (UUK used to known as the Committee of Vice-Chancellors and Principals).

Council for Health Regulatory Excellence (CHRE), soon to become the PSAHSC,

Back now to the CHRE, the people who failed so signally to sort out the GCC. They are being reorganised. Their consultation document says

"The Health and Social Care Act 20122 confers a new function on the Professional Standards Authority for Health and Social Care (the renamed Council for Healthcare Regulatory Excellence). From November 2012 we will set standards for organisations that hold voluntary registers for people working in health and social care occupations and we will accredit the register if they meet those standards. It will then be known as an ‘Accredited Register’. "

They are trying to decide what the criteria should be for "accreditation" of a regulatory body. The list of those interested has some perfectly respectable organisations, like the British Psychological Society. It also contains a large number of crackpot organisations, like Crystal and Healing International, as well as joke regulators like the CNHC.

They already oversee the Health Professions Council (HPC) which is due to take over Herbal medicine and Traditional Chinese Medicine, with predictably disastrous consequences.

Two of the proposed criteria for "accreditation" appear to be directly contradictory.

Para 2.5 makes the whole accreditation pointless from the point of view of patients

2.5 It will not be an endorsement of the therapeutic validity or effectiveness of any particular discipline or treatment.

Since the only thing that matters to the patient is whether the therapy works (and is safe), accrediting of organisations that ignore this will merely give the appearance of official approval of crystal healing etc etc. This appears to contradict directly

A.7 The organisation can demonstrate that there either is a sound knowledge base underpinning the profession or it is developing one and makes that explicit to the public.

A "sound knowledge base", if it is to mean anything useful at all, means knowledge that the treatment is effective. If it doesn’t mean that, what does it mean?

It seems that the official mind has still not grasped the obvious fact that there can be no sensible regulation of subjects that are untrue nonsense. If it is nonsense, the only form of regulation that makes any sense is the law.

Please fill in the consultation. My completed return can be downloaded as an example, if you wish.

Medicines and Healthcare products Regulatory Agency (MHRA) should be a top level defender of truth. Its strapline is

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

The MHRA did something (they won’t tell me exactly what) about one of the most cruel scams that I’ve ever encountered, Esperanza Homeopathic Neuropeptide, peddled for multiple sclerosis, at an outrageous price ( £6,759 for 12 month’s supply). Needless to say there was not a jot of evidence that it worked (and it wasn’t actually homeopathic).

The MHRA admit (when pushed really hard) that there is precious little evidence that any of the herbs work, and that homeopathy is nothing more than sugar pills. Their answer to that is to forget that bit about "ensuring that medicines … work"

Here’s the MHRA’s Traditional Herbal Registration Certificate for devils claw tablets.

The wording "based on traditional use only" has to be included because of European legislation. Shockingly, the MHRA have allowed them to relegate that to small print, with all the emphasis on the alleged indications. The pro-CAM agency NCCAM rates devil’s claw as "possibly effective" or "insufficient evidence" for all these indications, but that doesn’t matter because the MHRA requires no evidence whatsoever that the tablets do anything. They should, of course, added a statement to this effect to the label. They have failed in their duty to protect and inform the public by allowing this labelling.

But it gets worse. Here is the MHRA’s homeopathic marketing authorisation for the homeopathic medicinal product Arnicare Arnica 30c pillules

It is nothing short of surreal.

Since the pills contain nothing at all, they don’t have the slightest effect on sprains, muscular aches or bruising. The wording on the label is exceedingly misleading.

If you "pregnant or breastfeeding" there is no need to waste you doctor’s time before swallowing a few sugar pills.

"Do not take a double dose to make up for a missed one". Since the pills contain nothing, it doesn’t matter a damn.

"If you overdose . . " it won’t have the slightest effect because there is nothing in them

And it gets worse. The MHRA-approved label specifies ACTIVE INGREDIENT. Each pillule contains 30c Arnica Montana

No, they contain no arnica whatsoever.

It truly boggles the mind that men with dark suits and lots of letters after their names have sat for hours only to produce dishonest and misleading labels like these.

When this mislabeling was first allowed, it was condemned by just about every scientific society, but the MHRA did nothing.

### The Nightingale Collaboration.

This is an excellent organisation, set up by two very smart skeptics, Alan Henness and Maria MacLachlan. Visit their site regularly, sign up for their newsletter Help with their campaigns. Make a difference.

### Conclusions

The regulation of alternative medicine in the UK is a farce. It is utterly ineffective in preventing deception of patients.

Such improvements as have occurred have resulted from the activity of bloggers, and sometime the mainstream media. All the official regulators have, to varying extents, made things worse.

The CHRE proposals promise to make matters still worse by offering "accreditation" to organisations that promote nonsensical quackery. None of the official regulators seem to be able to grasp the obvious fact that is impossible to have any sensible regulation of people who promote nonsensical untruths. One gets the impression that politicians are more concerned to protect the homeopathic (etc, etc) industry than they are to protect patients.

Deception by advocates of alternative medicine harms patients. There are adequate laws that make such deception illegal, but they are not being enforced. The CHRE and its successor should restrict themselves to real medicine. The money that they spend on pseudo-regulation of quacks should be transferred to the MHRA or a reformed Trading Standards organisation so they can afford to investigate and prosecute breaches of the law. That is the only form of regulation that makes sense.

### Follow-up

The shocking case of the continuing sale of “homeopathic vaccines” for meningitis, rubella, pertussis etc was highlighted in an excellent TV programme by BBC South West. The failure of the MHRA and the GPC do take any effective action is a yet another illustration of the failure of regulators to do their job. I have to agree with Andy Lewis when he concludes

“Children will die. And the fault must lie with Professor Sir Kent Woods, chairman of the regulator.”

The College of Medicine is well known to be the reincarnation of the late unlamented Prince of Wales Foundation for Integrated Health. I labelled it as a Fraud and Delusion, but that was perhaps over-generous. It seems to be morphing into a major operator in the destruction of the National Health Service through its close associations with the private health industry.

Their 2012 Conference was held on 3rd May. It has a mixture of speakers, some quite sound, some outright quacks. It’s a typical bait and switch event. You can judge its quality by the fact that the picture at the top of the page that advertises the conference shows Christine Glover, a homeopathic pharmacist who makes a living by selling sugar pills to sick people (and a Trustee of the College of Medicine).

Her own company’s web site says

 "Worried about beating colds and flu this winter? We have several approaches to help you build your immune system." The approaches are, of course, based on sugar pills. The claim is untrue and dangerous. My name for that is fraud.

When the "College of Medicine" started it was a company, but on January 30th 2012, it was converted to being a charity. But the Trustees of the charity are the same people as the directors of the company. They are all advocates of ineffective quack medicine. The contact is named as Linda Leung, who was Operations Director of the Prince’s Foundation until it closed, and then became Company Secretary for the “College of Medicine”.

The trustees of the charity are the same people who were directors of the company

• Dr Michael Dixon, general practitioner. Michael Dixon was Medical Director of the Prince’s Foundation until it closed down.
• Professor George Lewith, is Professor of Health Research in the Complementary Medicine Research Unit, University of Southampton. He was a Foundation Fellow of the Prince’s Foundation until it closed down. Much has been written about him here.
• Professor David Peters. is Professor of Integrated Healthcare and Clinical Director at the University of Westminster’s School of Integrated Health; He’s famous for allowing dowsing with a pendulum as a method of diagnosis for treatment with unproven herbal medicines,
He was a Foundation Fellow of the Prince’s Foundation until it closed down.
• Mrs Christine Glover is a pharmacist who sells homeopathic pills. She was a Foundation Fellow of the Prince’s Foundation until it closed down.

### The involvement of Capita

According to their web site

"A Founder of the College of Medicine is Capita."

Still more amazingly, the CEO of the College of Medicine is actually an employee of Capita too.

"Mark Ratnarajah is interim CEO of the College of Medicine as well as Business Director at Capita Health and Wellbeing."

 That isn’t the end of it. The vice-president of the College of Medicine is Dr Harry Brunjes. There is an article about him in the May 2012 issue of Director Magazine. It has to be said that he doesn’t sound like a man with much interest in the National Health Service..

Within 9 years of graduating he set up in private practice in Harley Street. Five years later he set up Premier Medical, which, after swallowing a couple of rivals, he sold to Capita for £60 million. He is now recorded in a Companies House document as Dr Henry Otto Brunjes, a director of Capita Health Holdings Limited. This company owns all the shares in Capita Health and Wellbeing Limited, and it is, in turn, owned by Capita Business Services Limited. And they are owned by Capita Holdings Limited. I do hope that this baroquely complicated array of companies with no employees has nothing to do with tax avoidance.

Capita is, of course, a company with a huge interest in the privatisation of health care. It also has a pretty appalling record for ripping off the taxpayer.

It has long been known in Private Eye, as “Crapita” and “the world’s worst outsourcing firm”.

Capita were responsible for of the multimillion pound failed/delayed IT project for the NHS and HMRC. They messed up on staff administration services at Leicester Hospitals NHS Trust and the BBC where staff details were lost.  They failed to provide sufficient computing systems for the Criminal Records Bureau, which caused lengthy delays.  Capita were also involved in the failure of the Individual Learning Accounts following a £60M over-spend. And most recently, they have caused the near collapse of court translation services after their acquisition of Applied Language Services.

With allies like that, perhaps the College of Medicine hardly needs enemies. No doubt Capita will be happy to provide the public with quackery for an enormous fee from the taxpayer.

 One shouldn’t be surprised that the College is involved in Andrew Lansley’s attempts to privatise healthcare. Michael Dixon, Chair of the College of Medicine, also runs the "NHS Alliance", almost the only organisation that supported the NHS Bill. The quackery at his own practice defies belief (some it is described here).

One would have thought that such a close association with a company with huge vested interests would not be compatible with charitable status. I’ve asked the Charity Commission about that. The Charity commission, sadly, makes no judgements about the worthiness of the objects of the charities it endorses. All sorts of dangerous quack organisations are registered charities, like, for example, Yes to Life.

### Secrecy at the College of Medicine

One of the big problems about the privatisation of medicine and education is that you can’t use the Freedom of Information Act to discover what they are up to. A few private companies try to abide by that act, despite not being obliged to do so. But the College of Medicine is not one of them.

Capita They refuse to disclose anything about their relationship with Capita. I asked I asked Graeme Catto, who is a friend (despite the fact that I think he’s wrong). I got nothing.

"Critical appraisal" I also asked Catto for the teaching materials used on a course that they ran about "critical appraisal". Any university is obliged, by the decision of the Information Tribunal, to produce such material on request. The College of Medicine refused, point blank. What, one wonders, have they got to hide? Their refusal strikes me as deeply unethical.

The course (costing £100) on Critical Appraisal, ran on February 2nd 2012. The aims are "To develop introductory skills in the critical appraisal of randomised controlled trials (RCTs) and systematic reviews (SRs)". That sounds good. Have they had a change of heart about testing treatments?

But, as always, you have to look at who is running the course. Is it perhaps a statistician with expertise in clinical trials? Or is it a clinician with experience in running trials? There are plenty of people with this sort of expertise. But no, It is being run by a pharmacist, Karen Pilkington, from that hotbed of unscientific medicine, the University of Westminster.

Pilkington originally joined the University of Westminster as manager for a 4-year project to review the evidence on complementary therapies (funded by the Department of Health). All of her current activities centre round alternative medicine and most of her publications are in journals that are dedicated to alternative medicine. She teaches "Critical Appraisal" at Westminster too, so I should soon have the teaching materials, despite the College’s attempts to conceal them.

### Three people who ought to know better

Ore has to admire, however grudgingly, the way that the quacks who run the College of Medicine have managed to enlist the support of several people who really should know better. I suppose they have been duped by that most irritating characteristic of quacks, the tendency to pretend they have the monopoly on empathetic treatment of patients. We all agree that empathy is good, but every good doctor has it. One problem seems to be that senior medical people are not very good at using Google. They don’t do their homework.

 Professor Sir Graeme Catto MD DSc FRCP FMedSci FRSE is president of the College of Medicine. He’s Emeritus Professor of Medicine at the University of Aberdeen. He was President of the General Medical Council from 2002 to 2009, Pro Vice-Chancellor, University of London and Dean of Guy’s, King’s and St Thomas’ medical school between 2000 and 2005. He’s nice and well-meaning chap, but he doesn’t seem to know much about what’s going on in the College.

 Professor Sir Ian Kennedy LLD, FBA, FKC, FUCL, Hon.DSc(Glasgow), Hon.FRCP is vice-president of the College. Among many other things he is Emeritus Professor of Health Law, Ethics and Policy at University College London. He was Chair of the Healthcare Commission until 2003, when it merged with other regulators to form the Care Quality Commission. No doubt he can’t be blamed for the recent parlous performence of the CQC.

 Professor Aidan Halligan MA, MD, FRCOG, FFPHM, MRCPI Since March 200y he has been Director of Education at University College London Hospitals. From 2003 until 2005, he was Deputy Chief Medical Officer for England, with responsibility for issues of clinical governance, patient safety and quality of care. He’s undoubtedly a well-meaning man, but so focussed on his (excellent) homelessness project that he seems immune to the company he keeps. Perhaps the clue lies in the fact that when I asked him what he thought of Lansely’s health bill, he seemed to quite like it.

It seems to me to be incomprehensible that these three people should be willing to sign a letter in the British Medical Journal in defence of the College, with co-signatories George Lewith (about whom much has been written here) and the homeopath Christine Glover. In so doing, they betray medicine, they betray reason, and most important of all, they betray patients. Perhaps they have spent too much time sitting on very important committees and not enough time with patients.

The stated aims of the College sound good.

"A force that combines scientific knowledge, clinical expertise and the patient’s own perspective. A force that will re-define what good medicine means − renewing the traditional values of service, commitment and compassion and creating a more holistic, patient-centred, preventative approach to healthcare."

But what they propose to do about it is, with a few exceptions, bad. They try to whip up panic by exaggerating the crisis in the NHS. There are problems of course, but they result largely from under-funding (we still spend less on healthcare than most developed countries), and from the progressive involvement of for-profit commercial companies, like Capita. The College has the wrong diagnosis and the wrong solution. How do they propose to take care of an aging population? Self-care and herbal medicines seem to be their solution.

 The programme for the College’s workshop shows it was run by herbalist Simon Mills and by Dick Middleton an employee of the giant herbal company, Schwabe. You can see Middleton attempting to defend misleading labelling of herbal products on YouTube, opposed by me.

It seems that the College of Medicine are aiding and abetting the destruction of the National Health Service. That makes me angry.(here’s why)

I can end only with the most poignant tweet in the run up to the passing of the Health and Social Care Act. It was from someone known as @HeardInLondon, on March 15th

"For a brief period during 20th century, people gave a fuck and looked after each other. Unfortunately this proved unprofitable."

Unprofitable for Crapita, that is.

### Follow-up

5 May 2012. Well well, if there were any doubt about the endarkenment values of the College, I see that the Prince of Wales, the Quacktitioner Royal himself, gave a speech at the College’s conference.

"”I have been saying for what seems a very long time that until we develop truly integrated systems – not simply treating the symptoms of disease, but actively creating health, putting the patient at the heart of the process by incorporating our core human elements of mind, body and spirit – we shall always struggle, in my view, with an over-emphasis on mechanistic, technological approaches.”

Of course we all want empathy. The speech, as usual, contributes precisely nothing.

12 June 2012. Oh my, how did I manage to miss the fact the the College’s president, Professor Sir Graeme Catto, is also a Crapita eployee. It’s over a year since he was apponted to Capita’s clinical governance board he says "  In a rapidly growing health and wellbeing marketplace, delivering best practice in clinical governance is of utmost importance. I look forward to working with the team at Capita to assist them with continuing to adopt a best in class approach.". The operative word is "marketplace".

The offering of quack cancer treatments at an exorbitant price is simple cruelty. The nature of the Burzynski clinic has been known for some time. But it has come to a head with some utterly vile threatening letters sent to the admirable Andrew Lewis, because he told a few truths about Stanislaw Burzynskis despicable outfit. Please read his original post, The False Hope of the Burzynski Clinic.

I have to add by two-pennorth worth to the row that has blown up in the blogosphere at the outrageous behaviour of Burzynski. I hope other bloggers will do the same. There is safety in numbers. We need a Streisand effect to face down these pathetic bullies. It’s the "I am Spartacus" principle.

I won’t repeat all the details. They have spread like wildfire round the web. Briefly, it was sparked off by tragic case of a 4-year old girl, Billie Bainbridge who has a rare form of brain cancer. Well-intentioned pop stars have been trying to raise £200,000 to "enrol her into a clinical trial" at Burzynski clinic in Texas, despite the fact that Dr Stanislaw Burzynski has already been on trial for cancer fraud. In fact his clinic is not allowed to treat cancer patients, but it has evaded that ban, for many years, by pretending to run clinical trials. Normally patients volunteer for clinical trials. Sometimes they are paid a modest amount. Never, in the civilised world, are people asked to pay hundreds of thousands of pounds to be a guinea pig. Dorothy Bishop has written about The Weird World of US ethics regulation.

There is nothing new about this. The Cancerbusters site won the Anus Maximus Award for the year 2000. The award was announced in the following words:

The top award this year goes to the acolytes of Dr Stanislaw Burzynski who have created an advertising site at www.cancerbusters.com using a five-year-old boy named Thomas Navarro. Thomas is dying of cancer and this site exploits that tragedy to try and get the law changed so that quacks can have the untrammelled right to deceive desperate, sick people by promising them magic cures for cancer, AIDS and other diseases for which no cure is yet available. While this site is specifically a Burzynski promotion, his competitors support the site and mention it because if the campaign is successful it will dramatically increase the size of the market for quackery and therefore their opportunities to make money. [The boy died in November 2001]

The letters sent to Andrew Lewis are unspeakably nasty. They come from someone who calls himself "Marc Stephens" who claims to represent the company.

Then later, at the end of another “foam-flecked angry rant”

 . . . If you had no history of lying, and if you were not apart of a fraud network I would take the time to explain your article word for word, but you already know what defamation is.    I’ve already recorded all of your articles from previous years as well as legal notice sent by other attorneys for different matters.  As I mentioned, I am not playing games with you.  You have a history of being stubborn which will play right into my hands.  Be smart and considerate for your family and new child, and shut the article down..Immediately.  FINAL WARNING. Regards, Marc Stephens

Despite the attempt at legal style, "Marc Stephens" is not registered as an attorney in Texas.

Andy Lewis did not yield to this crude bullying. His post is still there for all to read. Before the days of the internet he would have been on his own. But now already dozens of blogs have drawn attention to what’s going on. Soon it will be hundreds. Burzynski can’t sue all of us. It’s the Streisand effect, or the "I am Spartacus" response.

Come on. Marc Stephens, make my day.

Some notes on the science

The Burzynski treatment is piss. Literally. A mixture of substances extracted from the patient’s own urine is dubbed with the preoposterous pseudoscientific name "antineoplastons". There are no such things as "neoplastons". And the chemicals are now made in the lab like any other drug.

 The main component seems to be a simple organic chemical, phenylacetic acid (PA). It is produced in normal metabolism but the liver copes with it by converting it to phenylacetyl glutamine (PAG), which is excreted in the urine.

Saul Green has summarised the evidence

Burzynski has never demonstrated that A-2.1 (PA) or “soluble A-10” (PA and PAG) are effective against cancer or that tumor cells from patients treated with these antineoplastons have been “normalized.” Tests of antineoplastons at the National Cancer Institute have never been positive. The drug company Sigma-Tau Pharmaceuticals could not duplicate Burzynski’s claims for AS-2.1 and A-10. The Japanese National Cancer Institute has reported that antineoplastons did not work in their studies. No Burzynski coauthors have endorsed his use of antineoplastons in cancer patients.

Cancer Research UK has a summary of the current evidence, Hope or false hope?

Despite it being illegal to advertise cancer cures in most country, the list of people who flout the law to make money from the desperate is enormous/ You can find a list of them at Quackwatch. Burzynski isn’t the only one but he could well be the most expensive.

Latest developments

You can follow the ever-growing list of publications by people who are determined to resist Burzynski at Josephine Jones "Stanislaw, Streisand and Spartacus". There is also a list at anarchic_teapot’s blog

### Follow-up

Monday 28 November The Streisand effect is developing rapidly. The definitive lists of posts are here and here. But there are two that I must mention.

Today Rhys Morgan has published Threats from The Burzynski Clinic. The same “Marc Stephens” has made the same sort of threats against him as he made against Lewis. Rhys Morgan is still at school, and is now 17 years old. He was the hero of the MMS scandal.

David Gorski, a real oncologist, has gone into the evidence in excellent detall with Stanislaw Burzynski: Bad medicine, a bad movie, and bad P.R.

It is a good thing that clinical trials have to be registered, but is not good that there is no obligation to reveal the outcome. Many are never published. Nobody knows quite why they are not published but clearly it is a source of ‘publication bias’ if results that somebody doesn’t like, whether for financial or ideological reasons, simply vanish.

That has been a problem with the pharmaceutical industry, as discussed by Ben Goldacre in This is a very broken system. For example, It has turned out that the SSRI antidepressants are essentially ineffective in mild/moderate depression, but that fact was concealed because negative trials were hidden by the drug companies. Likewise, it must be very tempting for homeopaths and other advocates of magic medicine, to quietly forget about trials that don’t come out as they wish. Nobody knows how often that happens, and Homeopaths certainly don’t always bury negative results. Peter Fisher has published trials with negative results. So has George Lewith. Both, needless to say, continue to prescribe it.

It seemed until this month that burial had been the fate of a trial of homeopathy at the Bristol Homeopathic Hospital, run by Dr Elizabeth Thompson.

Dr Thompson was also an author of the infamous paper, Spence et al (2005) paper [download pdf]. This paper was no more than a customer satisfaction survey. Half the patients felt better or much better after a visiting the Homeopathic Hospital, but there was no control group and so not the slightest reason to think that they felt better because of the homeopathic treatment. This pathetic apology for a trial is, needless to say, widely cited by homeopaths. Children with asthma were the group who most often said they felt better, and that might have been taken as a hint ro do a proper trial.

That isn’t what happened though. A small unblinded trial was proposed and it was run between January 1st 2005 and September
30th 2007. In March 2006 the University Hospitals Bristol NHS Trust announced a trial that was being run by Dr Elizabeth Thompson at the Bristol Homeopathic Hospital. The press release has now vanished, but it was reported by the BBC in May 2008.

But no results appeared. Soon people stared asking where the results were. It was discussed on the UKSKeptics forum in October 2006, and on the James Randi Educational Forum. I wrote to Dr Thompson in December 2007 to ask if their results of the asthma study were available yet, and got a rather rude reply (some details below). I was also told by Dr Thompson that

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

But it still didn’t appear. I and others wrote to the Hospital Trust but got nowhere. Two years later, In 2009, a Freedom of Information Act request was sent to the Hospital Trust (not by me) to try to discover what the still unpublished results were. In February 2010, the Hospital’s lawyers declined to provide the information on the grounds that publication was "imminent".

Then, at last, in July 2011,four years after it was promised, the paper appeared, in the journal Homeopathy. UCL does not, thank heavens, subscribe to that journal, but a request on Twitter produced three copies in no time: twitter is great for crowd-sourcing. The paper is The feasibility of a pragmatic randomised controlled trial to compare usual care with usual care plus individualised homeopathy, in children requiring secondary care for asthma.

It’s not surprising that publication was delayed. The results are completely negative. In fact it shows that the homeopathic treatment didn’t even produce a placebo effect, never mind an effect of its own.

### Some details of the paper

The paper compared ‘usual treatment’ with ‘usual treatment plus homeopathic treatment’ for children with asthma. Children were allocated randomly to one treatment or the other (good) but of course they were aware of what treatment they were getting (not good). Ernst has pointed out that this sort of trial can never give a negative result unless the homeopathic treatment is actually harmful. The usual care plus homeopathy group can only benefit from any placebo effect produced by the homeopathic consultation.

The pills used were all 12C dilutions or even weaker, so none of them contained anything whatsoever.

The remarkable thing about this trial was that there was no detectable difference between the ‘usual treatment’ and ‘usual treatment + homeopathy’ groups.

The homeopathic treatment was not just ineffective in itself, but it didn’t even have any detectable placebo effect.

In that respect, the result resembles those in a recent paper in the British Journal of General Practice that showed acupuncture didn’t even produce any useful placebo effect.

The trial was quite small, 39 children aged 7 – 14 years, with moderate or severe asthma were divided into the two groups, and 35 finished the trial. The follow-up periods was 16 weeks which should be enough to show any substantial effect on asthma. Twelve different outcomes were measured and none showed any difference between the two groups (despite the fact that no allowance was made for multiple comparisons, and no primary outcome was specified in advance).

A cost-benefit analysis was done. There was no benefit but there was certainly a cost. On average, each of the children in the usual care group cost the NHS £323, but when homeopathy was added, the cost was £937. That’s an extra cost of £615 for no benefit.

The authors’ conclusions are simple

Conclusions: A future study using this design is not feasible,

That’s pretty feeble. They don’t state the conclusion as "homeopathy doesn’t work", far less that "homeopathy doesn’t even have a placebo effect". Just the eternal cry after every failed trial of magic medicine: the trial design was wrong and more research is needed. An excuse was offered in the form

"A further limitation was the length of the study period which may have needed to be longer in order for homeopathic treatment to make an impact in a complex disease with high variabilitythrough the year."

This is a paraphrase of the typical homeopathic modus operandi. Keep trying a different pill until the patient gets better anyway, then claim the credit.

### Some details of the attempts to discover the results

Some of this was recounted in 2007, but it’s so bizarre I’ll repeat it here.

On 11 December 2007 I wrote to Dr Thompson, thus

 In March 2006, a press release http://www.ubht.nhs.uk/press/view.asp?257 announced a randomised trial for homeopathic treatment of asthma in children. This was reported also on the BBC http://news.bbc.co.uk/1/hi/england/bristol/4971050.stm . I’d be very grateful if you could let me know when results from this trial will become available. Yours sincerely David Colquhoun

The reply, dated 11 December 2007, was unsympathetic

 I have just submitted the funders report today and we have set ourselves the deadline to publish two inter-related papers by March 1st 2007. Can I ask why you are asking and what authority you have to gain this information. I shall expect a reply to my questions,

I answered this question politely on the same day, 11th December.

 I know we disagree about the strength of the existing evidence, but nevertheless I was surprised by the strength of your reaction, and the rather abusive stance about my scientific credentials. I’m rather interested in evidence (my first academic work was a text book on statistics), and I’m always eager to see new data. From little I could learn it seemed that your data might be rather better quality than usual. If the evidence is good enough, I’m quite happy to change my mind. That’s how science works isn’t it? With best regards David Colquhoun

Nevertheless my innocent enquiry drew forth a rather vitriolic complaint from Dr Thompson to the Provost of UCL (dated 14 December 2007). Despite the fact that I’d replied on December 11th, she said to the provost (with a lot more invective)

"As yet I have not received a reply from Professor Colquhoun as to the authority he is using to make direct enquiries to me about my research. I would be grateful if you could reassure me th~t UCL have really thought through the implications of having someone, with such strong opinions that seem to extend beyond reason, promoting their opinions at such a high profile".
Dr. E. A. Thompson, BA Oxon, MBBS, MRCP, FFHom,
Honorary Senior Lecturer in Palliative Medicine

In this case, the Provost came up trumps. On 14 January 2008 he replied to Thompson:

“I have looked at the email that you copied to me, and I must say that it seems an entirely proper and reasonable request. It is not clear to me why Professor Colquhoun should require some special authority to make such direct enquiries”.

Dr Thompson seems to be very sensitive. Now we have seen the results of her trial, perhaps it’s not surprising

### Follow-up

An email yesterday alerted me to YesToLife. This outfit seemed to me to be so dangerous that a word of warning is in the public interest.

Their own description says “YES TO LIFE is a new charitable initiative to open up a positive future for people with cancer in the UK by supporting an integrative* approach to cancer care”. That sounds sort of cuddly but lets look below the surface.

As so often, the funding seems to have been raised as the result of the death of an unfortunate 23 year old woman. Instead of putting the money into real research, yet another small charity was formed. My correspondent pointed out that “I came across them at St Pancras Station on Friday afternoon — they had a live DJ to draw in the crowd and were raising funds through bucket collections”. No doubt many people just see the word ‘cancer’ and put money in the bucket, without realising that their money will be spent on promoting nonsensical and ineffective treatments.

The supporters list.

The list of supporters tells you all you need to know, if you are familiar with the magic medicine business, though it might look quite convincing if you don’t know about the people. Sadly the list starts with some celebrities (I didn’t know before that Maureen Lipman was an enthusiast foir quackery -how very sad). But never mind the air-head celebrities. The more interesting supporters come later.

• Dr Rosy Daniel of Health Creation is an old friend. After I complained about her promotion of some herbal concoction called Carctol to “heal cancer”, she was reprimanded by Trading Standards for breaching the Cancer Act 1939, and forced to change the claims (in my view she should have neen prosecuted but, luckily of her, Trading Standards people are notoriously ineffective). There is, of course not the slightest reason to to think that Carctol works (download Carctol: Profits before Patients?). Read also what Cancer Research UK say about carctol.
Dr Daniel is also well known because ran a course that was, for one year, accredited by the University of Buckingham. But once the university became aware of the nonsense that was being taught on the course, they first removed her as the course director, and then removed accreditation from the course altogether. She then tried to run the course under the aegis of the Prince’s Foundation for Integrated Health, but even they turned her down. Now it is running as a private venture, and is being advertised by YesToLife.
• Boo Armstrong, “Chief Executive of The Prince’s Foundation for Integrated Health and Founder and Executive Director GetWellUK”. The web site is out of date since the Prince’s Foundation shut its doors a year ago. She runs a private company, GetWellUK, that was responsible for a very poor study of alternative medicine in Northern Ireland. So she has a vested interest in promoting it. See Peter Hain and GetwellUK: pseudoscience and privatisation in Northern Ireland
• Professor George Lewith. This is beginning to look like the usual list of suspects. I’ve had cause to write twice about the curious activities of Dr Lewith. See Lewith’s private clinic has curious standards, in 2006, and this year George Lewith’s private practice. Another case study. The make up your own mind about whether you’d trust him.
• Dr Michael Dixon OBE, Chairman NHS Alliance and Medical Director The Prince’s Foundation for Integrated Health. Again the job description is a year out of date. You can read about Dr Dixon at Prince of Wales Foundation for magic medicine: spin on the meaning of ‘integrated’. He seems to be a well meaning man for whom no new-age idea is too barmy.

In fact both Dixon and Lewith have moved to a reincarnation of the Prince’s Foundation known as the “College of Medicine” (actually it’s a couple of offices in Buckingham Street). See Don’t be deceived. The new “College of Medicine” is a fraud and delusion.
It seems to me incomprehensible that people such as Sir Graeme Catto, Sir Cyril Chantler and Sir Muir Grey are willing to be associated with people who behave like this.
• Charlotte Grobien, Managing Director, Give it Away. This seems to be a fund-raising organisation that has supported YesToLife. The lesson seems to be, never give money to fundraisers unless you know exactly where your money is going.

The Help Centre

YesToLife has a help centre. But beware, There is no medical person there. Just Traditional Chinese medicine (rather dangerous), acupuncture, osteopath and naturopathy (which means, roughly, do nothing and hope for the best).

Patrick Holford,

There can be no better indication of the standard of advice to be expected from YesToLife than the fact they are advertising a lecture by Holford, with the enticing title "Say no to cancer"."Through learning about the effects of diet and nutrition, people with cancer or at risk of developing cancer can be empowered to say Yes to Life and No to Cancer". Would that it were so easy. It will cost you £15.00.

Just in case there is still nobody who has heard of Holford, he is the media nutritionist who has an entire chapter devoted to him in Ben Goldacre’s Bad Science book, He has a whole website that has exposed his dubious advice, the excellent HolfordWatch. And you can find quite a lot about him on this blog. Try, for example, Patrick Holford’s CV: the strange case of Dr John Marks, and Response to a threatening letter from Mr Holford, or Holford’s untruthful and unsubstantiated advertisement

The treatments directory

Now we get to the truly scary bit of YesToLife, their treatment directory. Try searching for ‘cancer type’ and then "breast (metastatic)".. We find no mention of the advances in understanding of the genetics of breast cancer, nor ot real therapies like tamoxifen. What we find are four "alternative treatments".

• Neuroimmunomodulation Therapy It sounds impressive until you learn that its only proponent is a an 82 year old Venezuelan doctor with a clinic in Caracas. Even YesToLife doesn’t pretend that there is any evidence that it works
• Vitamin C Therapy The old chestnut cure-all Vitamin C Again even YesToLife don’t pretend there is any good evidence but it is still offered; treatment cost £3140.00 (what? Vitamin C is very cheap indeed)
• Dendritic Cell Therapy Said by YesToLife to be "well-researched", though that isn’t so for breast cancer (metastatic). Although possibly not as barmy as the other things that are recommended, it is nevertheless not shown to be effective for any sort of cancer,
• Gerson Therapy It is a sign of the extreme unreliability of advice given by YesToLife that they should still recommend anything as totally discredited as Gerson Therapy.Although YesToLife describes it as "well-researched" that is simply not true: there are no proper clinical trials. Cancer Research UK say

"Overall, there is no evidence to show that Gerson therapy works as a cure for cancer. "
"Available scientific evidence does not support claims that Gerson therapy can treat cancer. It is not approved for use in the United States. Gerson therapy can be very harmful to your health. Coffee enemas have been linked to serious infections, dehydration, constipation, colitis (inflammation of the colon), and electrolyte imbalances. In some people, particular aspects of the diet such as coffee enemas have been thought to be responsible for their death."

Recommended reading: The (Not-So-)Beautiful (Un)Truth about the Gerson protocol and cancer quackery, by David Gorski (breast cancer surgeon, writing in Science-based Medicine.

Conclusion

The information supplied by YesToLife is more likely to kill you than to cure you.

The next time you see somebody collecting for a "cancer charity" be very careful before you give them money.

### Follow-up

November 2012. It gets worse.

I had an email from someone who was distressed because a friend was trying to raise £15,000 to cover the cost of treatments recommended by YesToLife. The treatment is high-dose intravenous Vitamin C infusion. This is pure quackery. There isn’t the slightest reason to think it will affect the course of cancer, or the wellbeing of the patient. It is exploitation of the desperate. My heart sinks at the thought that a “charity” can be quite so wicked.

 Last year the Royal London Homeopathic Hospital was rebranded as the Royal London Hospital for Integrated Medicine (RLHIM). The exercise seems to have been entirely cosmetic. Sadly, they still practise the same nonsense, as described in Royal London Homeopathic Hospital rebranded. But how different will things be at the Royal London Hospital for Integrated Medicine?. Recently I came across a totally disgraceful pamphlet issued by the RLHIM [download pamphlet]. If you haven’t come across craniosacral therapy (and who could blame you, a new form of nonsense is invented daily), try these sources. EBM-first has an up-to-date collection of references. Why Cranial Therapy Is Silly, by Stephen Barrett, M.D. What is Craniosacral Therapy? Wikipedia gives the history and criticisms And the ASA Adjudication on Craniosacral Therapy Association

In short, it is yet another weird invention of an eccentric American osteopath, dating from the 1930s. Like Osteopathy and Chiropractic, there is no ancient wisdom involved, just an individual with an eye for what makes money.

### What the UCLH pamphlet claims

 The claims made in this pamphlet are utterly baseless. In fact there isn’t the slightest evidence that craniosacral therapy is good for anything. And its ‘principles’ are pure nonsense. No doubt that is why the Advertising Standards Authority has already delivered a damning indictment of rather similar claims made in a leaflet issued by the Craniosacral Therapy Association (CSTA)

" . . the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health and beauty products and therapies)."

"We noted that the CSTA believed that the leaflet was merely inviting readers to try CST to see if it could alleviate some of their symptoms and did not discourage them from seeing a doctor. However, we considered that the list of serious medical conditions in the ad, and the references to the benefit and help provided by CST, could encourage readers to use CST to relieve their symptoms rather than seek advice from a medical professional. We therefore concluded that the ad could discourage readers from seeking essential treatment for serious medical conditions from a qualified medical practitioner.

### Complaint through the official channels. It took 3 months to extract “No comment” from Dr Gill Gaskin

Given that I have every reason to be grateful to UCL Hospitals for superb care, i was hesitant to leap into print to condemn the irresponsible pamphlet issued by one of their hospitals. It seemed better to go through the proper channels and make a complaint in private to the UCL Hospitals Trust.

On 21st December 2010 I wrote to the directors of UCLH Trust

 I have just come across the attached pamphlet. “Craniosacral” therapy is a preposterous made-up invention. More to the point, there is no worthwhile evidence for the claims made in the pamphlet. The leaflet is, I contend, illegal under the Consumer protection regulations 2008. It is also deeply embarrassing that UCLH should be lending its name to this sort of thing. If you can think of any reason why I should not refer the pamphlet to the Advertising Standards Association, and to the office of Trading Standards, please let me know quickly. Best regards David Colquhoun

On 7th January 2011 I got an acknowledgment, which told me that my letter had been forwarded to the Medical Director for Specialist Hospitals for a response.

The Specialist Hospitals of the Trust include the Eastman Dental Hospital, The Heart Hospital, The National Hospital for Neurology & Neurosurgery (the famous Queen’s Square hospital) and, yes, The Royal London Hospital for Integrated Medicine. I’ve been a patient at three of them and have nothing but praise, Queen’s Square and the UCLH baby unit saved the life of my wife and my son in 1984 (see Why I love the National Health Service).

The Medical Director for Specialist Hospitals is Dr Gill Gaskin, and it is to her that my letter was forwarded. Of course it is not her fault that, in 2002, the Royal London Homeopathic Hospital (as it then was) was acquired by the UCLH Trust in 2002, The excuse given at the time was that the space was needed and the nonsense espoused by the RLHH would be squeezed out. That hasn’t yet happened.

After that nothing happened so I wrote directly to Dr Gaskin on 14th February 2011

 Dear Dr Gaskin The letter below was sent to the Trust on 20 December last year. I am told it was forwarded to you. I’m disappointed that I have still had no reply, after almost two months.  It was a serious enquiry and it has legal implications for the Trust. Would it help to talk about it in person? David Colquhoun

I got a quick reply, but sadly, as so often, the complaint had simply been forwarded to the object of the complaint. This sort of buck-passing is standard procedure for heading off complaints in any big organisation, in my experience.

 From: To: Cc: , Dear Professor Colquhoun   I received your email in January. I have now received the response from the Associate Clinical Director of the Royal London Hospital for Integrated Medicine, which is as set out below.   The brochure makes no claims of efficacy for Craniosacral Therapy (CST).  In terms of safety, only two randomised trials have reported adverse effects, neither found an excess of adverse effects of CST over control interventions (disconnected magnetotherapy equipment and static magnets respectively):   (Castro-Sanchez A et al.  A randomized controlled trial investigating the effects of craniosacral therapy on pain and heart rate variability in fibromyalgia patients. Clin Rehabil 2011 25: 25–35.  published online 11 August 2010 DOI: 10.1177/0269215510375909 Mann JD et al. Craniosacral therapy for migraine: Protocol development for an exploratory controlled clinical trial.   BMC Complementary and Alternative Medicine 2008, 8:28 published 9 June 2008 doi:10.1186/1472-6882-8-28) The only reports of adverse effects of CST relate to its use in traumatic brain injury.  (Greenman PE, McPartland JM. Cranial findings and iatrogenesis from craniosacral manipulation in patients with traumatic brain syndrome. J Am Osteopath Assoc 1995;95:182-88). The RLHIM does not treat this condition and it is not mentioned in the brochure.  The Craniosacral Therapy Association is planning a safety audit, to be launched later this year.  The RLHIM intends to participate in this. With best wishes   Gill Gaskin Dr Gill Gaskin Medical Director Specialist Hospitals Board UCLH NHS Foundation Trust

I don’t know who wrote this self-serving nonsense because there is no sign on the web of a job called "Associate Clinical Director of the Royal London Hospital for Integrated Medicine".

It is absurd to say that the leaflet makes “makes no claims of efficacy”. It says "Craniosacral therapy can be offered to children and adults for a variety of conditions:" and then goes on to list a whole lot of conditions, some of which are potentially serious, like "Recurrent ear infections and sinus infections, glue ear " and "Asthma". Surely anyone would suppose that if a UCLH Hopsital were offering a treatment for conditions like these, there would be at least some evidence that they worked. And there is no such evidence. This reply seemed to me to verge on the dishonest.

Remember too that this response was written on 16th February 2011, long after the Advertising Standards Association had said that there is no worthwhile evidence for claims of this sort, on 8th September 2010.

I replied at once

 Thanks for the reply, but I thought that this was your responsibility. Naturally the RLHIM will stick up for itself, so asking them gets us nowhere at all.  The buck stops with the Trust (in particular with you, I understand) and it is for you to judge whether pamphlets such as that I sent bring the Trust into disrepute . . .. I’d be very pleased to hear your reaction (rather than that of the RLHIM) to these comments.  It seems a reasonable thing to ask for, since responsibility for the RLHIM rests with you David Colquhoun

On the 13th March, after a couple of reminders, Dr Gaskin said "I will respond to you tomorrow or Tuesday,". No such luck though. On 25th March, more than three months after I first wrote, I eventually got a reply (my emphasis).

 I do not wish to comment further on the matter of the leaflets as a complaint to the advertising standards authority would be dealt with formally. I am aware of your views on complementary medicine, and of course am entirely open to you pointing out areas where you believe there is misleading information, and I ask colleagues to review such areas when highlighted. I would make several additional comments: – patients are referred into NHS services by their GPs (or occasionally by consultants in other services) and cannot self-refer – patients attending the Royal London Hospital for Integrated Medicine report positively on NHS Choices – GPs continue to make referrals to the Royal London Hospital for Integrated Medicine and many request that patients stay under follow-up, when UCLH seeks to reconfirm this – UCLH is engaging with North Central London NHS commissioners on work on their priorities, and that includes work on complementary medicine (and combinations of conventional and complementary approaches) I think you will understand that I will not wish to engage in lengthy correspondence, and have many other competing priorities at present. With best wishes Gill Gaskin

So, after three months’ effort, all I could get was ‘no comment‘, plus some anecdotes about satisfied customers -the stock in trade of all quacks.

I guess it is well known that complaints against any NHS organisation normally meet with a stonewall. That happens with any big organisation (universities too). Nevertheless it strikes me as dereliction of duty to respond so slowly, and in the end to say nothing anyway.

There are plans afoot to refer the UCLH pamphlet to the the Office of Trading Standards.IIt is for them to decide whether to prosecute the UCLH Trust for making false health claims. It is sad to have to say that they deserve to be prosecuted.

### Follow-up

28 March 2011. Two days after this post went up, a Google search for “Dr Gill Gaskin” brought up this post as #5 on the first page. Amazing.

On 25 May, the same search alluded to this post in positions 2, 3, 4 and 5 on the first page of Google.

29 June 2013

Despite several judgements by the Advertising Standards Authority (ASA) against claims made for craniosacral therapy, nothing was done.
But after UCLH Trust was comprehensively condemned by the ASA for the claims made for acupuncture by the RLHIM, at last we got action. All patient pamphlets have been withdrawn, and patient information is being revised.

. It isn’t obvious why this has taken more that two years (and one can only hope that the revised information will be more accurate)

The Prince of Wales’ Foundation for Integrated Health shut down amidst scandal in April 2010. In July, we heard that a new “College of Medicine” was to arise from its ashes. It seemed clear from the people involved that the name “College of Medicine” would be deceptive.

Now the College of Medicine has materialised, and it is clear that one’s worst fears were well justified.

At first sight, it looks entirely plausible and well-meaning. Below the logo one reads

“There is a new force in medicine. A force that brings patients, doctors, nurses and other health professionals together, instead of separating them into tribes.”

"That force is the new College of Medicine. Uniquely, it brings doctors and other health professionals together with patients and scientists.”

It is apparent from the outset that the well-meaning words fall into the trap described so clearly by James May (see What ‘holistic’ really means). It fails to distinguish between curing and caring.

As always, the clue lies not in the words, but in the people who are running it.

### Who is involved?

After a bit of digging on the web site, you find the names of the people on the Science Council of the “College of Medicine”, The preamble says

“Good medicine must be grounded in good science as well as compassion. The College’s Science Council brings a depth of knowledge from many senior figures.”

But then come the names. With the odd exception the “science council” is like a roll-call of quacks, the dregs left over from the Prince’s Foundation. The link (attached to each name) gives the College’s bio, My links tell a rather different story.

It seems that the "Scientific Council" of the College of Medicine could more properly be called an "Antiscientific Council".

There are a few gaps in this table, to be filled in soon. One can guarantee that a great deal more will appear about the College on the web, very soon.

The Governing Council of the College is equally replete with quacks (plus a few surprising names). It has on it, for example, a spiritual healer (Angie-Buxton King), a homeopath (Christine Glover), a herbalist (Michael McIntyre). Westminster University’s king of woo (David Peters), not to mention the infamous Karol Sikora. Buxton-King offers a remarkable service to heal people or animals at a distance.

Meanwhile, it seemed worthwhile to provide a warning that the title of the College is very deceptive. It hides an agenda that could do much harm.

It is, quite simply, the Prince of Wales by stealth.

### Follow-up

28 October 2010

Professor Sir Graeme Catto, who has, disgracefully, allowed his name to be used as president of this “College” has said to me “There are real problems in knowing how to care for folk with chronic conditions and the extent of the evidence base for medicine is pretty limited”.

Yes of course that is quite true. There are many conditions for which medicine can still do little. There is a fascinating discussion to be had about how best to care for them. The answer to that is NOT to bring in spiritual healers and peddlers of sugar pills to deceive patients with their fairy stories. The “College of Medicine” will delay and pervert the sort of discussion that Catto says, rightly, is needed.

29 October 2010

I need a press card. I see that the BMJ also had a piece about the “College of Medicine” yesterday: Prince’s foundation metamorphoses into new College of Medicine, by Nigel Hawkes. He got the main point right there in the title.

As was clear since July, the driving force was Michael Dixon, Devon GP and ex medical director of the Prince’s Foundation. Hawkes goes easy on the homeopaths and spiritual healers, but did spot something that I can’t find on their web site. The “Faculties” will include

“in 2011, neuromusculoskeletal care. Two of the six strong faculty members for this specialty are from the British Chiropractic Association, which sued the author Simon Singh for libel for his disobliging remarks about the evidence base for their interventions.”

The College certainly picks its moment to endorse chiropractic, a subject that is in chaos and disgrace after they lost the Singh affair.

One bit of good news emerges from Hawkes’ piece, There is at least one high profile doubter in the medical establishment, Lord (John) Walton (his 2000 report on CAM was less than blunt, and has been widely misquoted by quacks) is reported as saying, at the opening ceremony

“I’m here as a sceptic, and I’ve just told my former houseman that,” he said. The target of the remark was Donald Irvine, another former GMC president and a member of the new college’s advisory council.”

31 October 2010. I got an email that pointed out a remarkable service offered by a member of College’s Governing Council. Angie Buxton-King, a “spiritual healer” employed by UCLH seems to have another web site, The Beacon of Healing Light that is not mentioned in her biography on the College’s site. Perhaps it should have been because it makes some remarkable claims. The page about distant healing is the most bizarre.

Absent Healing/Distant Healing

"Absent healing is available when it is not possible to visit the patient or it is not possible for the patient to be brought to our healing room. This form of healing has proved to be very successful for humans and animals alike."

"We keep a healing book within our healing room and every night spend time sending healing to all those who have asked for it. We have found that if a picture of the patient is sent to us the healing is more beneficial, we also require a weekly update to monitor any progress or change in the patients situation. Donations are welcome for this service."

I wonder what the Advertising Standards people make of the claim that it is “very successful”? I wonder what the president of the College makes of it? I’ve asked him.

### Other blogs about the “College of Medicine”

30 October 2010. Margaret McCartney is always worth reading. As a GP she is at the forefront of medicine. She’s written about the College in The Crisis in Caring and dangerous inference. She’s also provided some information about a "professional member" of the College of Medicine, in ..and on Dr Sam Everington, at the Bromley by Bow Centre….

It is one of the more insulting things about alternative medicine addicts that they claim to be the guardians of caring (as opposed to curing), They are not, and people like McCartney and Michael Baum are excellent examples.

19 January 2011

Prince of Wales to become honorary president of the “College of Medicine?”

Last night I heard a rumour that the Prince of Wales is, despite all the earlier denials, to become Honorary President of the “College”. If this is true, it completes the wholesale transformation of the late, unlamented, Prince’s Foundation for Integrated Medicine into this new “College”. Can anybody take it seriously now?

Text messages to Graeme Catto and Michael Dixon, inviting them to deny the rumour, have met with silence.

### Herbal nonsense at the College

29 July 2011. I got an email from the College if Medicine [download it]. It contains a lot of fantasy about herbal medicines, sponsered by a company that manufactures them. It is dangeroous and corrupt.

 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