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This piece is almost identical with today’s Spectator Health article.

This week there has been enormously wide coverage in the press for one of the worst papers on acupuncture that I’ve come across. As so often, the paper showed the opposite of what its title and press release, claimed. For another stunning example of this sleight of hand, try Acupuncturists show that acupuncture doesn’t work, but conclude the opposite: journal fails, published in the British Journal of General Practice).

Presumably the wide coverage was a result of the hyped-up press release issued by the journal, BMJ Acupuncture in Medicine. That is not the British Medical Journal of course, but it is, bafflingly, published by the BMJ Press group, and if you subscribe to press releases from the real BMJ. you also get them from Acupuncture in Medicine. The BMJ group should not be mixing up press releases about real medicine with press releases about quackery. There seems to be something about quackery that’s clickbait for the mainstream media.

As so often, the press release was shockingly misleading: It said

Acupuncture may alleviate babies’ excessive crying Needling twice weekly for 2 weeks reduced crying time significantly

This is totally untrue. Here’s why.

 Luckily the Science Media Centre was on the case quickly: read their assessment. The paper made the most elementary of all statistical mistakes. It failed to make allowance for the jelly bean problem. The paper lists 24 different tests of statistical significance and focusses attention on three that happen to give a P value (just) less than 0.05, and so were declared to be "statistically significant". If you do enough tests, some are bound to come out “statistically significant” by chance. They are false postives, and the conclusions are as meaningless as “green jelly beans cause acne” in the cartoon. This is called P-hacking and it’s a well known cause of problems. It was evidently beyond the wit of the referees to notice this naive mistake. It’s very doubtful whether there is anything happening but random variability. And that’s before you even get to the problem of the weakness of the evidence provided by P values close to 0.05. There’s at least a 30% chance of such values being false positives, even if it were not for the jelly bean problem, and a lot more than 30% if the hypothesis being tested is implausible. I leave it to the reader to assess the plausibility of the hypothesis that a good way to stop a baby crying is to stick needles into the poor baby. If you want to know more about P values try Youtube or here, or here.

One of the people asked for an opinion on the paper was George Lewith, the well-known apologist for all things quackish. He described the work as being a "good sized fastidious well conducted study ….. The outcome is clear". Thus showing an ignorance of statistics that would shame an undergraduate.

On the Today Programme, I was interviewed by the formidable John Humphrys, along with the mandatory member of the flat-earth society whom the BBC seems to feel obliged to invite along for "balance". In this case it was professional acupuncturist, Mike Cummings, who is an associate editor of the journal in which the paper appeared. Perhaps he’d read the Science media centre’s assessment before he came on, because he said, quite rightly, that

"in technical terms the study is negative" "the primary outcome did not turn out to be statistically significant"

to which Humphrys retorted, reasonably enough, “So it doesn’t work”. Cummings’ response to this was a lot of bluster about how unfair it was for NICE to expect a treatment to perform better than placebo. It was fascinating to hear Cummings admit that the press release by his own journal was simply wrong.

Listen to the interview here

Another obvious flaw of the study is that the nature of the control group. It is not stated very clearly but it seems that the baby was left alone with the acupuncturist for 10 minutes. A far better control would have been to have the baby cuddled by its mother, or by a nurse. That’s what was used by Olafsdottir et al (2001) in a study that showed cuddling worked just as well as another form of quackery, chiropractic, to stop babies crying.

Manufactured doubt is a potent weapon of the alternative medicine industry. It’s the same tactic as was used by the tobacco industry. You scrape together a few lousy papers like this one and use them to pretend that there’s a controversy. For years the tobacco industry used this tactic to try to persuade people that cigarettes didn’t give you cancer, and that nicotine wasn’t addictive. The main stream media obligingly invite the representatives of the industry who convey to the reader/listener that there is a controversy, when there isn’t.

Acupuncture is no longer controversial. It just doesn’t work -see Acupuncture is a theatrical placebo: the end of a myth. Try to imagine a pill that had been subjected to well over 3000 trials without anyone producing convincing evidence for a clinically useful effect. It would have been abandoned years ago. But by manufacturing doubt, the acupuncture industry has managed to keep its product in the news. Every paper on the subject ends with the words "more research is needed". No it isn’t.

Acupuncture is pre-scientific idea that was moribund everywhere, even in China, until it was revived by Mao Zedong as part of the appalling Great Proletarian Revolution. Now it is big business in China, and 100 percent of the clinical trials that come from China are positive.

if you believe them, you’ll truly believe anything.

### Follow-up

29 January 2017

Soon after the Today programme in which we both appeared, the acupuncturist, Mike Cummings, posted his reaction to the programme. I thought it worth posting the original version in full. Its petulance and abusiveness are quite remarkable.

I thank Cummings for giving publicity to the video of our appearance, and for referring to my Wikipedia page. I leave it to the reader to judge my competence, and his, in the statistics of clinical trials. And it’s odd to be described as a "professional blogger" when the 400+ posts on dcscience.net don’t make a penny -in fact they cost me money. In contrast, he is the salaried medical director of the British Medical Acupuncture Society.

It’s very clear that he has no understanding of the error of the transposed conditional, nor even the mulltiple comparison problem (and neither, it seems, does he know the meaning of the word ‘protagonist’).

I ignored his piece, but several friends complained to the BMJ for allowing such abusive material on their blog site. As a result a few changes were made. The “baying mob” is still there, but the Wikipedia link has gone. I thought that readers might be interested to read the original unexpurgated version. It shows, better than I ever could, the weakness of the arguments of the alternative medicine community. To quote Upton Sinclair:

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

It also shows that the BBC still hasn’t learned the lessons in Steve Jones’ excellent “Review of impartiality and accuracy of the BBC’s coverage of science“. Every time I appear in such a programme, they feel obliged to invite a member of the flat earth society to propagate their make-believe.

### Acupuncture for infantile colic – misdirection in the media or over-reaction from a sceptic blogger?

26 Jan, 17 | by Dr Mike Cummings

So there has been a big response to this paper press released by BMJ on behalf of the journal Acupuncture in Medicine. The response has been influenced by the usual characters – retired professors who are professional bloggers and vocal critics of anything in the realm of complementary medicine. They thrive on oiling up and flexing their EBM muscles for a baying mob of fellow sceptics (see my ‘stereotypical mental image’ here). Their target in this instant is a relatively small trial on acupuncture for infantile colic.[1] Deserving of being press released by virtue of being the largest to date in the field, but by no means because it gave a definitive answer to the question of the efficacy of acupuncture in the condition. We need to wait for an SR where the data from the 4 trials to date can be combined.
On this occasion I had the pleasure of joining a short segment on the Today programme on BBC Radio 4 led by John Humphreys. My protagonist was the ever-amusing David Colquhoun (DC), who spent his short air-time complaining that the journal was even allowed to be published in the first place. You can learn all about DC care of Wikipedia – he seems to have a surprisingly long write up for someone whose profession career was devoted to single ion channels, perhaps because a significant section of the page is devoted to his activities as a quack-busting blogger. So why would BBC Radio 4 invite a retired basic scientist and professional sceptic blogger to be interviewed alongside one of the journal editors – a clinician with expertise in acupuncture (WMA)? At no point was it made manifest that only one of the two had ever been in a position to try to help parents with a baby that they think cries excessively. Of course there are a lot of potential causes of excessive crying, but I am sure DC would agree that it is unlikely to be attributable to a single ion channel.

So what about the research itself? I have already said that the trial was not definitive, but it was not a bad trial. It suffered from under-recruiting, which meant that it was underpowered in terms of the statistical analysis. But it was prospectively registered, had ethical approval and the protocol was published. Primary and secondary outcomes were clearly defined, and the only change from the published protocol was to combine the two acupuncture groups in an attempt to improve the statistical power because of under recruitment. The fact that this decision was made after the trial had begun means that the results would have to be considered speculative. For this reason the editors of Acupuncture in Medicine insisted on alteration of the language in which the conclusions were framed to reflect this level of uncertainty.

DC has focussed on multiple statistical testing and p values. These are important considerations, and we could have insisted on more clarity in the paper. P values are a guide and the 0.05 level commonly adopted must be interpreted appropriately in the circumstances. In this paper there are no definitive conclusions, so the p values recorded are there to guide future hypothesis generation and trial design. There were over 50 p values reported in this paper, so by chance alone you must expect some to be below 0.05. If one is to claim statistical significance of an outcome at the 0.05 level, ie a 1:20 likelihood of the event happening by chance alone, you can only perform the test once. If you perform the test twice you must reduce the p value to 0.025 if you want to claim statistical significance of one or other of the tests. So now we must come to the predefined outcomes. They were clearly stated, and the results of these are the only ones relevant to the conclusions of the paper. The primary outcome was the relative reduction in total crying time (TC) at 2 weeks. There were two significance tests at this point for relative TC. For a statistically significant result, the p values would need to be less than or equal to 0.025 – neither was this low, hence my comment on the Radio 4 Today programme that this was technically a negative trial (more correctly ‘not a positive trial’ – it failed to disprove the null hypothesis ie that the samples were drawn from the same population and the acupuncture intervention did not change the population treated). Finally to the secondary outcome – this was the number of infants in each group who continued to fulfil the criteria for colic at the end of each intervention week. There were four tests of significance so we need to divide 0.05 by 4 to maintain the 1:20 chance of a random event ie only draw conclusions regarding statistical significance if any of the tests resulted in a p value at or below 0.0125. Two of the 4 tests were below this figure, so we say that the result is unlikely to have been chance alone in this case. With hindsight it might have been good to include this explanation in the paper itself, but as editors we must constantly balance how much we push authors to adjust their papers, and in this case the editor focussed on reducing the conclusions to being speculative rather than definitive. A significant result in a secondary outcome leads to a speculative conclusion that acupuncture ‘may’ be an effective treatment option… but further research will be needed etc…

Now a final word on the 3000 plus acupuncture trials that DC loves to mention. His point is that there is no consistent evidence for acupuncture after over 3000 RCTs, so it clearly doesn’t work. He first quoted this figure in an editorial after discussing the largest, most statistically reliable meta-analysis to date – the Vickers et al IPDM.[2] DC admits that there is a small effect of acupuncture over sham, but follows the standard EBM mantra that it is too small to be clinically meaningful without ever considering the possibility that sham (gentle acupuncture plus context of acupuncture) can have clinically relevant effects when compared with conventional treatments. Perhaps now the best example of this is a network meta-analysis (NMA) using individual patient data (IPD), which clearly demonstrates benefits of sham acupuncture over usual care (a variety of best standard or usual care) in terms of health-related quality of life (HRQoL).[3]

30 January 2017

I got an email from the BMJ asking me to take part in a BMJ Head-to-Head debate about acupuncture. I did one of these before, in 2007, but it generated more heat than light (the only good thing to come out of it was the joke about leprechauns). So here is my polite refusal.

 Hello Thanks for the invitation, Perhaps you should read the piece that I wrote after the Today programme http://www.dcscience.net/2017/01/20/if-your-baby-is-crying-what-do-you-do-stick-pins-in-it/#follow Why don’t you do these Head to Heads about genuine controversies? To do them about homeopathy or acupuncture is to fall for the “manufactured doubt” stratagem that was used so effectively by the tobacco industry to promote smoking. It’s the favourite tool of snake oil salesman too, and th BMJ should see that and not fall for their tricks. Such pieces night be good clickbait, but they are bad medicine and bad ethics. All the best David

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 is a web version of a review of Peter Gotzsche’s book. It appeared in the April 2014 Healthwatch Newsletter. Read the whole newsletter. It has lots of good stuff. Their newsletters are here. Healthwatch has been exposing quackery since 1989. Their very first newsletter is still relevant.

 Most new drugs and vaccines are developed by the pharmaceutical industry. The industry has produced huge benefits for mankind. But since the Thatcherite era it has come to be dominated by marketing people who appear to lack any conscience. That’s what gave rise to the Alltrials movement. It was founded in January 2013 with the aim of ensuring that all past and present clinical trials are registered before they start and that and their results are published The industry has been dragged, kicking and screaming, towards a new era of transparency, with two of the worst offenders, GSK and Roche, now promising to release all data. Let’s hope this is the beginning of real open science.

This version is not quite identical with the published version in which several changes were enforced by Healthwatch’s legal adviser. They weren’t very big changes, but here is the original.

### Deadly Medicines and Organised Crime

By Peter Gøtzsche, reviewed by David Colquhoun
ISBN-10: 1846198844 ISBN-13: 978-1846198847

As someone who has spent a lifetime teaching pharmacology, this book is a bitter pill to swallow.  It makes Goldacre’s Bad Pharma seem quite mild.

In fairness, the bits of pharmacology that I’ve taught concern mostly drugs that do work quite well.  Things like neuromuscular blocking agents, local anaesthetics, general anaesthetics, anticoagulants, cardiac glycosides and thyroid drugs all do pretty much what is says on the label.

Peter Gøtzsche is nothing if not evidence man.  He directs the Nordic Cochrane group, and he talks straight.  His book is about drugs that don’t work as advertised.  There is no doubt whatsoever that the pharmaceutical industry has behaved very badly indeed in the last couple of decades.  You don’t have to take my word for it, nor Peter Gotzche’s, nor Ben Goldacre’s.  They have told us about it themselves.  Not voluntarily of course, but in internal emails that have been revealed during court proceedings, and from whistleblowers.

Peter Rost was vice president marketing for the huge pharmaceutical company, Pfizer, until he was fired after the company failed to listen to his complaints about illegal marketing of human growth hormone as an anti-ageing drug.  After this he said:

“It is scary how many similarities there are between this industry and the mob. The mob makes obscene amounts of money, as does this industry. The side effects of organized crime are killings and deaths, and the side effects are the same in this industry. The mob bribes politicians and others, and so does the drug industry … “

The pharmaceutical industry is the biggest defrauder of the US federal government under the False Claims Act.  Roche led a cartel that, according to the US Justice Department’s antitrust division, was the most pervasive and harmful criminal antitrust conspiracy ever uncovered.  Multibillion dollar fines have been levied on all of the big companies (almost all in the USA, other countries have been supine), though the company’s profits are so huge they are regarded as marketing expenses.

It’s estimated that adverse effects of drugs kill more people than anything but cancer and heart disease, roughly half as many as cigarettes.  This horrifying statistic is announced at the beginning of the book, though you have to wait until Chapter 21 to find the data.  I’d have liked to see a more critical discussion of the problems of causality in deciding why someone died, which are just as big as those in deciding why somebody recovered.  Nevertheless, nobody seems to deny that the numbers who are killed by their treatments are alarmingly high.

Gøtzsche’s book deals with a wide range of drugs that don’t do what it says on the label, but which have made fortunes because of corruption of the scientific process. These include non-steroidal anti-inflammatory drugs (NSAIDs), an area described as “a horror story filled with extravagant claims, bending of the rules, regulatory inaction, . . .”.  Other areas where there has been major misbehaviour include diabetes (Avandia), and the great Tamiflu scandal. and the great Tamiflu scandal. It took five years of pressure before Roche released the hidden data about Tamiflu trials. It barely works. Goldacre commented “government’s Tamiflu stockpile wouldn’t have done us much good in the event of a flu epidemic”

But the worst single area is psychiatry.

Two of the chapters in the book deal with psychiatry.  Nobody has the slightest idea how the brain works (don’t believe the neuroscience hype) or what causes depression or psychosis.  Treatments are no more than guesses and none of them seems to work very well.

The problems with the SSRI antidepressant, paroxetine (Seroxat in UK, Paxil in USA) were brought to public attention, not by a regulator, but by a BBC Panorama television programme.  The programme revealed that a PR company, which worked for GSK, had written

"Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results.  Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicise."

This referred to the now-notorious study 329. It was intended to show that paroxetine should be recommended for adolescent depression.  The paper that eventually appeared in 2001 grossly misrepresented the results.  The conclusions stated “Paroxetine is generally well tolerated and effective for major depression in adolescents”, despite the fact that GSK already knew this wasn’t true. The first author of this paper was Martin Keller, chair of psychiatry at Brown University, RI, with 21 others.

But the paper wasn’t written by them, but by ghost authors working for GSK. Keller admitted that he hadn’t checked the results properly.

That’s not all. Gøtzsche comments thus.

“Keller is some character. He double- billed his travel expenses, which were reimbursed both by his university and the drug sponsor. Further, the Massachusetts Department of Mental Health had paid Brown’s psychiatry department, which Keller chaired, hundreds of thousands of dollars to fund research that wasn’t being conducted. Keller himself received hundreds of thousands of dollars from drug companies every year that he didn’t disclose.”

His department received $50 million in research funding. Brown University has never admitted that there was a problem. It still boasts about this infamous paper The extent of corruption at Brown University rivals the mob. The infamous case of Richard Eastell at Sheffield university is no better. He admitted in print to lying about who’d seen the data. The university did nothing but fire the whistleblower. Another trial, study 377, also showed that paroxetine didn’t work. GSK suppressed it. “There are no plans to publish data from Study 377” (Seroxat/Paxil Adolescent Depression. Position piece on the phase III clinical studies. GlaxoSmithKline document. 1998 Oct.) Where were the regulatory agencies during all this? The MHRA did ban use of paroxetine in adolescents in 2003, but their full investigation didn’t report until 2008. It came to much the same conclusions as the TV programme six years earlier about the deceit. But despite that, no prosecution was brought. GSK got away with a deferential rap on the knuckles. Fiona Godlee (editor of the BMJ, which had turned down the paper) commented “We shouldn’t have to rely on investigative journalists to ask the difficult questions” Now we can add bloggers to that list of people who ask difficult questions. The scam operated by the University of Wales, in ‘validating’ external degrees was revealed by my blog and by BBC TV Wales. The Quality Assurance Agency came in only at the last moment. Regulators regularly fail to regulate.  Despite all this, the current MHRA learning module on SSRIs contains little hint that SSRIs simply don’t work for mild or moderate depression. Neither does the current NICE guidance. Some psychiatrists still think they do work, despite there being so many negative trials. The psychiatrists’ narrative goes like this. You don’t expect to see improvements for many weeks (despite the fact that serotonin uptake is stopped immediately). You may get worse before you get better. And if the first sort of pill doesn’t work, try another one. That’s pretty much identical with what a homeopath will tell you. The odds are that its meaning is, wait a while and you’ll get better eventually, regardless of treatment. It’s common to be told that they must work because when you stop taking them, you get worse. But, perhaps more likely, when you stop taking them you get withdrawal symptoms, because the treatment itself caused a chemical imbalance. Gøtzsche makes a strong case that most psychiatric drugs do more harm than good, if taken for any length of time. Marcia Angell makes a similar case in The Illusions of Psychiatry. Gøtzsche will inevitably be accused of exaggerating. Chapter 14 ends thus. “Merck stated only 6 months before it withdrew Vioxx that ‘MSD is fully committed to the highest standards of scientific integrity, ethics, and protection of patient’s wellbeing in our research. We have a tradition of partnership with leaders in the academic research community. Great. Let’s have some more of such ethical partnerships. They often kill our patients while everyone else prospers. Perhaps Hells Angels should consider something similar in their PR: We are fully committed to the highest standards of integrity, ethics and protection of citizens’ well- being when we push narcotic drugs. We have a tradition of partnership with leaders in the police force”. But the evidence is there. The book has over 900 references. Much of the wrongdoing has been laid bare by legal actions. I grieve for the state of my subject. The wrongdoing by pharma is a disgrace. The corruption of universities and academics is even worse, because they are meant to be our defence against commercial corruption. All one can do is to take consolation from the fact that academics, like Gøtzsche and Goldacre, and a host of bloggers, are the people who are revealing what’s wrong. As a writer for the business magazine, Fortune, said “For better or worse, the drug industry is going to have to get used to Dr. Peter Rost – and others like him.” At a recent meeting I said that it was tragic that medicine, the caring profession, was also the most corrupt (though I’m happy to admit that other jobs might be as bad if offered as much money). At present there is little transparency. There is no way that I can tell whether my doctor is taking money from pharma, data are still hidden from public scrutiny by regulatory agencies (which are stuffed with people who take pharma money) as well as by companies. Governments regard business as more important than patients. In the UK, the Government continued promotion of the fake bomb detector for many years after they’d been told it was fake. Their attitude to fake medicines is not much different. Business is business, right? One side effect of the horrific corruption is that it’s used as a stick by the alternative medicine industry. That’s silly of them, because their business is more or less 100% mendacious marketing of ineffective treatments. At least half of pharma products really do work. Fines are useless. Nothing will change until a few CEOs, a few professors and a few vice-chancellors spend time in jail for corruption. Read this book. Get angry. Do something. ### Follow-up 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 The consistent failure of ‘regulators’ to do their job has been a constant theme on this blog. There is a synopsis of dozens of them at Regulation of alternative medicine: why it doesn’t work, and never can. And it isn’t only quackery where this happens. The ineptitude (and extravagance) of the Quality Assurance Agency (QAA) was revealed starkly when the University of Wales’ accreditation of external degrees was revealed (by me and by BBC TV Wales, not by the QAA) to be so bad that the University had to shut down. Here is another example that you couldn’t make up. Yes, the Professional Standards Authority (PSA) has agreed to accredit that bad-joke pseudo-regulator, the Complementary & Natural Healthcare Council (CNHC, more commonly known as Ofquack) Ofquack was created at the instigation of HRH the Prince of Wales, at public expense, as a means of protecting the delusional beliefs of quacks from criticism. I worked for them for a while, and know from the inside that their regulation is a bad joke. When complaints were made about untrue claims made by ‘reflexologists’, the complaints were upheld but they didn’t even reach the Conduct and Competence committee, on the grounds that the reflexologists really believed the falsehoods that they’d been taught. Therefore, by the Humpty Dumpty logic of the CNHC, their fitness to practise was not affected by their untrue claims. You can read the account of this bizarre incident by the person who submitted the complaints, Simon Perry. In fact in the whole history of the CNHC, it has received a large number of complaints, but only one has ever been considered by their Conduct and Competence Committee. The rest have been dismissed before they were considered properly. That alone makes their claim to be a regulator seem ridiculous. The CNHC did tell its registrants to stop making unjustified claims, but it has been utterly ineffective in enforcing that ruling. In May 2013, another 100 complaints were submitted and no doubt they will be brushed aside too: see Endemic problems with CNHC registrants.. As I said at the time It will be fascinating to see how the CNHC tries to escape from the grave that it has dug for itself. If the CNHC implements properly its own code of conduct, few people will sign up and the CNHC will die. If it fails to implement its own code of conduct it would be shown to be a dishonest sham. In February of this year (2013), I visited the PSA with colleagues from the Nightingale Collaboration. We were received cordially enough, but they seemed to be bureaucrats with no real understanding of science. We tried to explain to them the fundamental dilemma of the regulation of quacks, namely that no amount of training will help when the training teaches things that aren’t true. They were made aware of all of the problems described above. But despite that, they ended up endorsing the CNHC. ### How on earth did the PSA manage to approve an obviously ineffective ‘regulator’? The job of the PSA is said to be “. . . protecting users of health and social care services and the public”. They (or at least their predecessor, the CHRE), certainly didn’t do that during the saga of the General Chiropractic Council. The betrayal of reason is catalogued in a PSA document [get local copy]. Here is some nerdy detail. It is too tedious to go through the whole document, so I’ll deal with only two of its many obvious flaws, the sections that deal with the evidence base, and with training. The criteria for accreditation state Standard 6: the organisation demonstrates that there is a defined knowledge base underpinning the health and social care occupations covered by its register or, alternatively, how it is actively developing one. The organisation makes the defined knowledge base or its development explicit to the public. The Professional Standards Authority recognises that not all disciplines are underpinned by evidence of proven therapeutic value. Some disciplines are subject to controlled randomized trials, others are based on qualitative evidence. Some rely on anecdotes. Nevertheless, these disciplines are legal and the public choose to use them. The Authority requires organisations to make the knowledge base/its development clear to the public so that they may make informed decisions. Since all 15 occupations that are “regulated” by the CNHC fall into the last category. they “rely on anecdotes”, you would imagine the fact that “The Authority requires organisations to make the knowledge base/its development clear to the public” would mean that the CNHC was required to make a clear statement that reiki, reflexology etc are based solely on anecdote. Of course the CNHC does no such thing. For example, the CNHC’s official definition of reflexology says Reflexology is a complementary therapy based on the belief that there are reflex areas in the feet and hands which are believed to correspond to all organs and parts of the body There is, of course, not the slightest reason to think such connections exist, but the CNHC gives no hint whatsoever of that inconvenient fact. The word “anecdote” is used by the PSA but occurs nowhere on the CNHC’s web site. It is very clear that the CNHC fails standard 6. But the PSA managed to summon up the following weasel words to get around this glaring failure: “The professional associations (that verify eligibility for CNHC registration) were actively involved in defining the knowledge base for each of the 15 professions. The Panel further noted that Skills for Health has lead responsibility for writing and reviewing the National Occupational Standards (NOS) for the occupations CNHC registers and that all NOS have to meet the quality criteria set by the UK Commission for Employment and Skills (UKCES), who are responsible for the approval of all NOS across all industry sectors. The Panel considered evidence provided and noted that the applicant demonstrated that there is a defined knowledge base underpinning the occupations covered by its registers. The knowledge base was explicit to the public”. The PSA, rather than engaging their own brains, simply defer to two other joke organisations, Skills for Health and National Occupational Standards. But it is quite obvious that for things like reiki, reflexology and craniosacral therapy, the “knowledge base” consists entirely of made-up nonsense. Any fool can see that (but not, it seems, the PSA). Skills for Health lists made-up, HR style, “competencies” for everything under the sun. When I got them to admit that their efforts on distance-healing etc had been drafted by the Prince of Wales’ Foundation, the conversation with Skills for Health became surreal (recorded in January 2008) DC. Well yes the Prince of Wales would like that. His views on medicine are well known, and they are nothing if not bizarre. Haha are you going to have competencies in talking to trees perhaps? “You’d have to talk to LANTRA, the land-based organisation for that.” DC. I’m sorry, I have to talk to whom? “LANTRA which is the sector council for the land-based industries uh, sector, not with us sorry . . . areas such as horticulture etc.” DC. We are talking about medicine aren’t we? Not horticulture. “You just gave me an example of talking to trees, that’s outside our remit ” You couldn’t make it up, but it’s true. And the Professional Standards Authority rely on what these jokers say. The current Skills for Health entry for reflexology says “Reflexology is the study and practice of treating reflex points and areas in the feet and hands that relate to corresponding parts of the body. Using precise hand and finger techniques a reflexologist can improve circulation, induce relaxation and enable homeostasis. These three outcomes can activate the body’s own healing systems to heal and prevent ill health.” This is crass, made-up nonsense. Of course there are no connections between “areas in the feet and hands that relate to corresponding parts of the body” and no reason to think that reflexology is anything more than foot massage. That a very expensive body, paid for by you and me, can propagate such preposterous nonsense is worrying. That the PSA should rely on them is even more worrying. National Occupational Standards is yet another organisation that is utterly dimwitted about medical matters, but if you look up reflexology you are simply referred to Skills for Health, as above. UK Commission for Employment and Skills (UKCES) is a new one on me. The PSA says that “the UK Commission for Employment and Skills (UKCES), who are responsible for the approval of all NOS across all industry sectors” It is only too obvious that the UKCES leadership team have failed utterly to do their job when it comes to made-up medicine. None of them know much about medicine. It’s true that their chairman did once work for SmithKline Beecham, but as a marketer of Lucozade, a job which anyone with much knowledge of science would not find comfortable.. You don’t need to know much medicine to spot junk. I see no excuse for their failure. The training problem. The PSA’s criteria for accreditation say Standard 9: education and training The organisation: 9a) Sets appropriate educational standards that enable its registrants to practise competently the occupation(s) covered by its register. In setting its standards the organisation takes account of the following factors: • The nature and extent of risk to service users and the public • The nature and extent of knowledge, skill and experience required to provide service users and the public with good quality care and later 9b) Ensures that registrants who assess the health needs of service users and provide any form of care and treatment are equipped to: • Recognise and interpret clinical signs of impairment • Recognise where a presenting problem may mask underlying pathologies • Have sufficient knowledge of human disease and social determinants of health to identify where service users may require referral to another health or social care professional. Anyone who imagines for a moment that a reflexologist or a craniosacral therapist is competent to diagnose a subarachnoid haemorrhage or malaria must need their head examining. In any case, the CNHC has already admitted that their registrants are taught things that aren’t true, so more training presumably means more inculcation of myths. So how does the PSA wriggle out of this? Their response started “The Panel noted that practitioners must meet, as a minimum, the National Occupational Standards for safe and competent practice. This is verified by the professional associations, who have in turn provided written undertakings to CNHC affirming that there are processes in place to verify the training and skills outcomes of their members to the NOS” Just two problems there. The NOS standards themselves are utterly delusional. And checking them is left to the quacks themselves. To be fair, the PSA weren’t quite happy with this, but after an exchange of letters, minor changes enabled the boxes to be ticked and the PSA said “The Panel was now satisfied from the evidence provided, that this Standard had been met”. ### What’s wrong with regulators? This saga is typical of many other cases of regulators doing more harm than good. Regulators are sometimes quacks themselves, in which case one isn’t surprised at their failure to regulate. But organisations like the Professional Standards Authority and Skills for Health are not (mostly) quacks themselves. So how do they end up giving credence to nonsense? I find that very hard to comprehend, but here are a few ideas. (1) They have little scientific education and are not really capable of critical thought (2) Perhaps even more important, they lack all curiosity. It isn’t very hard to dig under the carapace of quack organisations, but rather than finding out for themselves, the bureaucrats of the PSA are satisfied by reassuring letters that allow them to tick their boxes and get home. (3) A third intriguing possibility is that people like the PSA yield to political pressure. The Department of Health is deeply unscientific and clearly has no idea what to do about alternative medicine. They have still done nothing at all about herbal medicine, traditional Chinese medicine or homeopathy, after many years of wavering. My guess is that they see the CNHC as an organisation that gives the appearance that they’ve done something about reiki etc. I wonder whether they applied pressure to the PSA to accredit CNHC, despite it clearly breaking their own rules. I have sent a request under the Freedom of Information Act in an attempt to discover if the Department of Health has misbehaved in the way it did when it attempted to override NHS Choices. The responsibility for this cock-up has to rest squarely on the shoulders of the PSA’s director, Harry Cayton. He was director of the CHRE from which PSA evolved and is the person who so signally failed to do anything about the General Chiropractic Council fiasco, ### What can be done? This is just the latest of many examples of regulators who not only fail to help but actually do harm by giving their stamp of approval to mickey mouse organisations like the CNHC. Most of the worst quangos survived the “bonfire of the quangos”.. The bonfire should have started with the PSA, CNHC and Skills for Health. They cost a lot and do harm. There is a much simpler answer. There is a good legal case that much of alternative medicine is illegal. All one has to do is to enforce the existing law. Nobody would object to quacks if they stopped making false claims (though whether they could stay in business if they stopped exaggerating is debatable). There is only one organisation that has done a good job when it comes to truthfulness. That is the Advertising Standards Authority. But the ASA can do nothing apart from telling people to change the wording of their advertisements, and even that is often ignored. The responsibility for enforcing the Consumer Protection Law is Trading Standards. They have consistently failed to do their job (see Medico-Legal Journal, Rose et al., 2012. “Spurious Claims for Health-care Products“. If they did their job of prosecuting people who defraud the public with false claims, the problem would be solved. But they don’t, and it isn’t. ### Follow-up The indefatigable Quackometer has wriiten an excellent account of the PSA fiasco 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., hardcover$26.99 ISBN: 0062222961 Reviewed by David Colquhoun Research Professor of Pharmacology, UCL.

Here’s an odd thing. There is a group of people who advocate the silly idea that you can cure all ills by stuffing yourself with expensive pills, made by large and unscrupulous Pharma companies.  No, I’m not talking about pharmacologists or doctors or dietitians.  They mostly say that stuffing yourself with pills is often useless and sometimes harmful, because that’s what the evidence says .

Rather, the pill pushers are the true believers in the alternative realities of the “supplement” industry. They seem blithely unaware that the manufacturers are mostly the same big pharma companies that they blame for trying to suppress “natural remedies”.  Far from trying to suppress them, pharma companies love the supplement industry because little research is needed and there are few restrictions on the claims that can be made.

Paul Offit’s excellent book concentrates on alternative medicine in the USA, with little mention of the rest of the world. He describes how American pork barrel politics have given supplement hucksters an almost unrestricted right to make stuff up.

Following the thalidomide tragedy, which led to birth defects in babies in the 1950s and 60s, many countries passed laws that required evidence that a drug was both effective and safe before it could be sold.  This was mandate by the Kefauver-Harris amendment (1961) in the USA and the Medicines Act (1968) in the UK.  Laws like that upset the quacks, and in the UK the quacks got a free pass, a ‘licence of right‘, largely still in existence.

 In order to sell a herbal concoction in the UK you need to present no evidence at all that it works, just evidence of safety, in return for which you get a reassuring certification mark and freedom to use misleading brand names and labels. Tradional herbal mark

In the USA the restrictions didn’t last long.  Offit describes how a lobby group for vitamin sellers, the National Health Federation, had a board made up of quacks, some of whom, according to Offit (page 73) had convictions.  They found an ally in Senator William Proxmire who introduced in 1975 an amendment that banned the Food and Drugs Administration (FDA) from regulating the safety of megavitamins.  Tragically, this bill was even supported by the previously-respected scientist Linus Pauling.  Offit tells us that “to Proxmire” became a verb meaning to obstruct science for political gain.

The author then relates  how the situation got worse with the passage of the  Dietary Supplement Health and Education Act (DSHEA) in 1994. It was passed with the help of ex-vitamin salesman Senator Orin Hatch and lots of money from the supplement industry.

This act iniquitously defined a “supplement” as “a product intended to supplement the diet that bears or contains one or more of the following ingredients: a vitamin, a mineral, an herb or other botanical, or an amino acid”.  At a stroke, herbs were redefined as foods.  There was no need to submit any evidence of either efficacy or even of safety, before marketing anything. All a manufacturer had to do to sell almost any herbal drug or megadose vitamin was to describe it as a “dietary supplement”.  The lobbying to get this law through was based on appealing to the Tea Party tendency –get the government’s hands off our vitamins. And it was helped by ‘celebrities’ such as Sissy Spacek and Mel Gibson (it’s impossible to tell whether they really believed in the magic of vitamins, or whether they were paid, or had Tea Party sympathies).

Offit’s discussion of vaccination is a heartbreaking story of venom and misinformation. As co-inventor of the first rotavirus vaccine he’s responsible for saving many lives around the world.  But he, perhaps more than anyone, suffered from the autism myth started by the falsified work of Andrew Wakefield.

The scientific community took the question seriously and soon many studies showed absolutely no link between vaccination and autism.  But evidence did not seem to interest the alternative world.  Rather than Offit being lauded as a saver of children’s lives, he describes how he was subjected to death threats and resorted to having armed guards at meetings.

Again, Offit tells us how celebrities were able to sway public opinion   For example (chapter 6), the actress Jenny McCarthy and talk-show hostess Oprah Winfrey promoted, only too successfully, the vaccine-autism link despite abundant evidence that it didn’t exist, and promoted a number of theories that were not supported by any evidence, such as the idea that autism can be “cured” by mega-doses of vitamins and supplements.

Of course vaccines like the one for rotavirus can’t be developed without pharmaceutical companies because, as Offit says, only they "have the resources and expertise to make a vaccine. We can’t make it in our garage".  When the Children’s Hospital of Philadelphia sold its royalty stake in the rotavirus vaccine for $182 million, Offit received an undisclosed share of the intellectual property, “in the millions ”. That’s exactly what universities love. We are encouraged constantly to collaborate with industry, and, in the process, make money for the university. It’s also what Wakefield, and the Royal Free Hospital where he worked, hoped to do. But sadly, these events led to Offit being called names such as “Dr Proffit” and “Biostitute” (to rhyme with “prostitute”) by people like Jenny McCarthy and Robert F. Kennedy Jr. The conspiritorialist public lapped up this abuse, but appeared not to notice that many quacks have become far richer by peddling cures that do not work. One lesson from this sad story is that we need to think more about the potential for money to lead to good science being disbelieved, and sometimes to corrupt science. Everyone should buy this book, and weep for the gullibility and corruption that it describes. I recommend it especially to the deans of US Medical schools, from Harvard downwards, who have embraced “integrative medicine” departments. In doing so they have betrayed both science and their patients. Abraham Flexner, whose 1910 report first put US medicine on a sound scientific footing, must be turning in his grave. ### Follow-up 30 August 2013 Quack lobby groups got a clause inserted into Obamacare that will make any attempt to evaluate whether a treatment actually works will leave insurance companies open to legal action for "discrimination". "Discrimination? Yes! We must not allow the government to exclude health care providers just because those providers don’t cure anything." The latest piece of well-organised corporate corruption by well-funded lobbyists is revealed by Steven Salzberg, in Forbes Magazine. The chaos in the US health system makes one even more grateful for the NHS and for the evaluation of effectiveness of treatments by NICE. Jump to follow-up Anesthesia & Analgesia is the official journal of the International Anesthesia Research Society. In 2012 its editor, Steven Shafer, proposed a head-to-head contest between those who believe that acupuncture works and those who don’t. I was asked to write the latter. It has now appeared in June 2013 edition of the journal [download pdf]. The pro-acupuncture article written by Wang, Harris, Lin and Gan appeared in the same issue [download pdf]. Acupuncture is an interesting case, because it seems to have achieved greater credibility than other forms of alternative medicine, despite its basis being just as bizarre as all the others. As a consequence, a lot more research has been done on acupuncture than on any other form of alternative medicine, and some of it has been of quite high quality. The outcome of all this research is that acupuncture has no effects that are big enough to be of noticeable benefit to patients, and it is, in all probablity, just a theatrical placebo. After more than 3000 trials, there is no need for yet more. Acupuncture is dead. ### Acupuncture is a theatrical placebo David Colquhoun (UCL) and Steven Novella (Yale) Anesthesia & Analgesia, June 2013 116:1360-1363. Pain is a big problem. If you read about pain management centres you might think it had been solved. It hasn’t. And when no effective treatment exists for a medical problem, it leads to a tendency to clutch at straws. Research has shown that acupuncture is little more than such a straw. Although it is commonly claimed that acupuncture has been around for thousands of years, it hasn’t always been popular even in China. For almost 1000 years it was in decline and in 1822 Emperor Dao Guang issued an imperial edict stating that acupuncture and moxibustion should be banned forever from the Imperial Medical Academy. Acupuncture continued as a minor fringe activity in the 1950s. After the Chinese Civil War, the Chinese Communist Party ridiculed traditional Chinese medicine, including acupuncture, as superstitious. Chairman Mao Zedong later revived traditional Chinese Medicine as part of the Great Proletarian Cultural Revolution of 1966 (Atwood, 2009). The revival was a convenient response to the dearth of medically-trained people in post-war China, and a useful way to increase Chinese nationalism. It is said that Chairman Mao himself preferred Western medicine. His personal physician quotes him as saying “Even though I believe we should promote Chinese medicine, I personally do not believe in it. I don’t take Chinese medicine” Li {Zhisui Li. Private Life Of Chairman Mao: Random House, 1996}. The political, or perhaps commercial, bias seems to still exist. It has been reported by Vickers et al. (1998) (authors who are sympathetic to alternative medicine) that "all trials [of acupuncture] originating in China, Japan, Hong Kong, and Taiwan were positive"(4). Acupuncture was essentially defunct in the West until President Nixon visited China in 1972. Its revival in the West was largely a result of a single anecdote promulgated by journalist James Reston in the New York Times, after he’d had acupuncture in Beijing for post-operative pain in 1971. Despite his eminence as political journalist, Reston had no scientific background and evidently didn’t appreciate the post hoc ergo propter hoc fallacy, or the idea of regression to the mean. After Reston’s article, acupuncture quickly became popular in the West. Stories circulated that patients in China had open heart surgery using only acupuncture (Atwood, 2009). The Medical Research Council (UK) sent a delegation, which included Alan Hodgkin, to China in 1972 to investigate these claims , about which they were skeptical. In 2006 the claims were repeated in 2006 in a BBC TV program, but Simon Singh (author of Fermat’s Last Theorem) discovered that the patient had been given a combination of three very powerful sedatives (midazolam, droperidol, fentanyl) and large volumes of local anaesthetic injected into the chest. The acupuncture needles were purely cosmetic. Curiously, given that its alleged principles are as bizarre as those on any other sort of pre-scientific medicine, acupuncture seemed to gain somewhat more plausibility than other forms of alternative medicine. The good thing about that is that more research has been done on acupuncture than on just about any other fringe practice. The outcome of this research, we propose, is that the benefits of acupuncture, if any, are too small and too transient to be of any clinical significance. It seems that acupuncture is little or no more than a theatrical placebo. The evidence for this conclusion will now be discussed. Three things that are not relevant to the argument There is no point in discussing surrogate outcomes such as fMRI studies or endorphine release studies until such time as it has been shown that patients get a useful degree of relief. It is now clear that they don’t. There is also little point in invoking individual studies. Inconsistency is a prominent characteristic of acupuncture research: the heterogeneity of results poses a problem for meta-analysis. Consequently it is very easy to pick trials that show any outcome whatsoever. Therefore we shall consider only meta-analyses. The argument that acupuncture is somehow more holistic, or more patient-centred, than medicine seems us to be a red herring. All good doctors are empathetic and patient-centred. The idea that empathy is restricted to those who practice unscientific medicine seems both condescending to doctors, and it verges on an admission that empathy is all that alternative treatments have to offer. There is now unanimity that the benefits, if any, of acupuncture for analgesia, are too small to be helpful to patients. Large multicenter clinical trails conducted in Germany {Linde et al., 2005; Melchart et, 2005; Haake et al, 2007, Witt et al, 2005), and in the United States {Cherkin et al, 2009) consistently revealed that verum (or true) acupuncture and sham acupuncture treatments are no different in decreasing pain levels across multiple chronic pain disorders: migraine, tension headache, low back pain, and osteoarthritis of the knee. If, indeed, sham acupuncture is no different from real acupuncture the apparent improvement that may be seen after acupuncture is merely a placebo effect. Furthermore it shows meridians don’t exist, so the "theory" memorized by qualified acupuncturists is just myth. All that remains to be discussed is whether or not the placebo effect is big enough to be useful, and whether it is ethical to prescribe placebos. Some recent meta-analyses have found that there may be a small difference between sham and real acupuncture. Madsen Gøtzsche & Hróbjartsson {2009) looked at thirteen trials with 3025 patients, in which acupuncture was used to treat a variety of painful conditions. There was a small difference between ‘real’ and sham acupuncture (it didn’t matter which sort of sham was used), and a somewhat bigger difference between the acupuncture group and the no-acupuncture group. The crucial result was that even this bigger difference corresponded to only a 10 point improvement on a 100 point pain scale. A consensus report (Dworkin, 2009) that a change of this sort should be described as a “minimal” change or “little change”. It isn’t big enough for the patient to notice much effect. The acupuncture and no-acupuncture groups were, of course, not blind to the patients and neither were they blind to the practitioner giving the treatment. It isn’t possible to say whether the observed difference is a real physiological action or whether it’s a placebo effect of a rather dramatic intervention. Interesting though it would be to know this, it matters not a jot, because the effect just isn’t big enough to produce any tangible benefit. Publication bias is likely to be an even greater problem for alternative medicine than it is for real medicine, so it is particularly interesting that the result just described has been confirmed by authors who practise, or sympathise with, acupuncture. Vickers et al. (2012) did a meta-analysis for 29 RCTs, with 17,922 patients. The patients were being treated for a variety of chronic pain conditions. The results were very similar to those of Madsen et al.{2009). Real acupuncture was better than sham, but by a tiny amount that lacked any clinical significance. Again there was a somewhat larger difference in the non-blind comparison of acupuncture and no-acupuncture, but again it was so small that patients would barely notice it. Comparison of these two meta-analyses shows how important it is to read the results, not just the summaries. Although the outcomes were similar for both, the spin on the results in the abstracts (and consequently the tone of media reports) was very different. An even more extreme example of spin occurred in the CACTUS trial of acupuncture for " ‘frequent attenders’ with medically unexplained symptoms” (Paterson et al., 2011). In this case, the results showed very little difference even between acupuncture and no-acupuncture groups, despite the lack of blinding and lack of proper controls. But by ignoring the problems of multiple comparisons the authors were able to pick out a few results that were statistically significant, though trivial in size. But despite this unusually negative outcome, the result was trumpeted as a success for acupuncture. Not only the authors, but also their university’s PR department and even the Journal editor issued highly misleading statements. This gave rise to a flood of letters to the British Journal of General Practice and much criticism on the internet. From the intellectual point of view it would be interesting to know if the small difference between real and sham acupuncture found in some, but not all, recent studies is a genuine effect of acupuncture or whether it is a result of the fact that the practitioners are never blinded, or of publication bias. But that knowledge is irrelevant for patients. All that matters for them is whether or not they get a useful degree of relief. There is now unanimity between acupuncturists and non-acupuncturists that any benefits that may exist are too small to provide any noticeable benefit to patients. That being the case it’s hard to see why acupuncture is still used. Certainly such an accumulation of negative results would result in the withdrawal of any conventional treatment. Specific conditions Acupuncture should, ideally, be tested separately for effectiveness for each individual condition for which it has been proposed (like so many other forms of alternative medicine, that’s a very large number). Good quality trials haven’t been done for all of them. It’s unlikely that acupuncture works for rheumatoid arthritis, stopping smoking, irritable bowel syndrome or for losing weight. And there is no good reason to think it works for addictions, asthma, chronic pain, depression, insomnia, neck pain, shoulder pain or frozen shoulder, osteoarthritis of the knee, sciatica, stroke or tinnitus and many other conditions (Ernst et al., 2011). In 2009, the UK’s National Institute for Clinical Excellence (NICE) did recommend both acupuncture and chiropractic for back pain. This exercise in clutching at straws caused something of a furore. In the light of NICE’s judgement the Oxford Centre for Evidence-based medicine updated its analysis of acupuncture for back pain. Their verdict was “Clinical bottom line. Acupuncture is no better than a toothpick for treating back pain.” The paper by Artus et al. (2010) is of particular interest for the problem of back pain. Their Fig 2 shows that there is a modest improvement in pain scores after treatment, but much the same effect, with the same time course is found regardless of what treatment is given, and even with no treatment at all. They say “we found evidence that these responses seem to follow a common trend of early rapid improvement in symptoms that slows down and reaches a plateau 6 months after the start of treatment, although the size of response varied widely. We found a similar pattern of improvement in symptoms following any treatment, regardless of whether it was index, active comparator, usual care or placebo treatment”. It seems that most of what’s being seen is regression to the mean. And that is very likely to be the main reason why acupuncture sometimes appears to work when it doesn’t. Although the article by Wang et al (2012) was written to defend the continued use of acupuncture, the only condition for which they claim that there is any reasonably strong evidence is for post-operative nausea and vomiting (PONV). It would certainly be odd if a treatment that had been advocated for such a wide variety of conditions turned out to work only for PONV. Nevertheless, let’s look at the evidence. The main papers that are cited to support the efficacy of acupuncture in alleviation of PONV are all from the same author: Lee & Done (1999), and two Cochrane reviews, Lee & Done (2004), updated in Lee & Fan (2009). We need only deal with this latest updated meta-analysis. Although the authors conclude “P6 acupoint stimulation prevented PONV”, closer examination shows that this conclusion is very far from certain. Even taken at face value, a relative risk of 0.7 can’t be described as “prevention”. The trials that were included were not all tests of acupuncture but included several other more or less bizarre treatments (“acupuncture, electro-acupuncture, transcutaneous nerve stimulation, laser stimulation, capsicum plaster, an acu-stimulation device, and acupressure”). The number needed to treat varied from a disastrous 34 to a poor 5 for patients with control rates of PONV of 10% and 70% respectively. The meta-analysis showed, on average, similar effectiveness for acupumcture and anti-emetic drugs. The problem is that the effectiveness of drugs is in doubt because an update to the Cochrane review has been delayed (Carlisle, 2012) by the discovery of major fraud by a Japanese anesthetist, Yoshitaka Fujii (Sumikawa, 2012). It has been suggested that metclopramide barely works at all (Bandolier, 2012; Henzi, 1999). Of the 40 trials (4858 participants) that were included; only four trials reported adequate allocation concealment. Ninety percent of trials were open to bias from this source. Twelve trials did not report all outcomes. The opportunities for bias are obvious. The authors themselves describe all estimates as being of “Moderate quality” which is defined this:Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate”. That being the case, perhaps the conclusion should have been “more research needed”. In fact almost all trials of alternative medicines seem to end up with the conclusion that more research is needed. Conclusions It is clear from meta-analyses that results of acupuncture trials are variable and inconsistent, even for single conditions. After thousands of trials of acupuncture, and hundreds of systematic reviews (Ernst et al., 2011), arguments continue unabated. In 2011, Pain carried an editorial which summed up the present situation well. “Is there really any need for more studies? Ernst et al. (2011) point out that the positive studies conclude that acupuncture relieves pain in some conditions but not in other very similar conditions. What would you think if a new pain pill was shown to relieve musculoskeletal pain in the arms but not in the legs? The most parsimonious explanation is that the positive studies are false positives. In his seminal article on why most published research findings are false, Ioannidis (2005) points out that when a popular but ineffective treatment is studied, false positive results are common for multiple reasons, including bias and low prior probability.” Since it has proved impossible to find consistent evidence after more than 3000 trials, it is time to give up. It seems very unlikely that the money that it would cost to do another 3000 trials would be well-spent. A small excess of positive results after thousands of trials is most consistent with an inactive intervention. The small excess is predicted by poor study design and publication bias. Further, Simmons et al (2011) demonstrated that exploitation of "undisclosed flexibility in data collection and analysis" can produce statistically positive results even from a completely nonexistent effect. With acupuncture in particular there is documented profound bias among proponents (Vickers et al., 1998). Existing studies are also contaminated by variables other than acupuncture – such as the frequent inclusion of "electroacupuncture" which is essentially transdermal electrical nerve stimulation masquerading as acupuncture. The best controlled studies show a clear pattern – with acupuncture the outcome does not depend on needle location or even needle insertion. Since these variables are what define "acupuncture" the only sensible conclusion is that acupuncture does not work. Everything else is the expected noise of clinical trials, and this noise seems particularly high with acupuncture research. The most parsimonious conclusion is that with acupuncture there is no signal, only noise. The interests of medicine would be best-served if we emulated the Chinese Emperor Dao Guang and issued an edict stating that acupuncture and moxibustion should no longer be used in clinical practice. No doubt acupuncture will continue to exist on the High Streets where they can be tolerated as a voluntary self-imposed tax on the gullible (as long as they don’t make unjustified claims).  REFERENCES 1. Acupuncture Centre. . About Acupuncture. Available at: http://www.acupuncturecentre.org/aboutacupuncture.html. Accessed March 30, 2013 2. Atwood K. “Acupuncture Anesthesia”: a Proclamation from Chairman Mao (Part IV). Available at: http://www.sciencebasedmedicine.org/index.php/acupuncture-anesthesia-a-proclamation-from-chairman-mao-part-iv/. Accessed September 2, 2012 3. Li Z Private Life of Chairman Mao: The Memoirs of Mao’s Personal Physician. 1996 New York: Random House 4. Vickers A, Goyal N, Harland R, Rees R. Do certain countries produce only positive results? A systematic review of controlled trials. Control Clin Trials. 1998;19:159–66 Available at: http://bit.ly/WqVGWN. Accessed September 2, 2012 5. Reston J. Now, About My Operation in Peking; Now, Let Me Tell You About My Appendectomy in Peking … The New York Times. 1971 Available at: http://select.nytimes.com/gst/abstract.html?res=FB0D11FA395C1A7493C4AB178CD85F458785F9. Accessed March 30, 2013 6. Atwood K. “Acupuncture anesthesia”: a proclamation from chairman Mao (part I). Available at: http://www.sciencebasedmedicine.org/index.php/acupuncture-anesthesia-a-proclamation-of-chairman-mao-part-i/. Accessed September 2, 2012 7. Linde K, Streng A, Jürgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for patients with migraine: a randomized controlled trial. JAMA. 2005;293:2118–25 8. Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Hummelsberger J, Irnich D, Weidenhammer W, Willich SN, Linde K. Acupuncture in patients with tension-type headache: randomised controlled trial. BMJ. 2005;331:376–82 9. Haake M, Müller HH, Schade-Brittinger C, Basler HD, Schäfer H, Maier C, Endres HG, Trampisch HJ, Molsberger A. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 2007;167:1892–8 10. Witt C, Brinkhaus B, Jena S, Linde K, Streng A, Wagenpfeil S, Hummelsberger J, Walther HU, Melchart D, Willich SN. Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet. 2005;366:136–43 11. Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med. 2009;169:858–66 12. Madsen MV, Gøtzsche PC, Hróbjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ. 2009;338:a3115 13. Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009;146:238–44 14. Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012;172:1444–53 15. Paterson C, Taylor RS, Griffiths P, Britten N, Rugg S, Bridges J, McCallum B, Kite G. Acupuncture for ‘frequent attenders’ with medically unexplained symptoms: a randomised controlled trial (CACTUS study). Br J Gen Pract. 2011;61:e295–e305 16. . Letters in response to Acupuncture for ‘frequent attenders’ with medically unexplained symptoms. Br J Gen Pract. 2011;61 Available at: http://www.ingentaconnect.com/content/rcgp/bjgp/2011/00000061/00000589. Accessed March 30, 2013 17. Colquhoun D. Acupuncturists show that acupuncture doesn’t work, but conclude the opposite: journal fails. 2011 Available at: http://www.dcscience.net/?p=4439. Accessed September 2, 2012 18. Ernst E, Lee MS, Choi TY. Acupuncture: does it alleviate pain and are there serious risks? A review of reviews. Pain. 2011;152:755–64 19. Colquhoun D. NICE falls for Bait and Switch by acupuncturists and chiropractors: it has let down the public and itself. 2009 Available at: http://www.dcscience.net/?p=1516. Accessed September 2, 2012 20. Colquhoun D. The NICE fiasco, part 3. Too many vested interests, not enough honesty. 2009 Available at: http://www.dcscience.net/?p=1593. Accessed September 2, 2012 21. Bandolier. . Acupuncture for back pain—2009 update. Available at: http://www.medicine.ox.ac.uk/bandolier/booth/painpag/Chronrev/Other/acuback.html. Accessed March 30, 2013 22. Artus M, van der Windt DA, Jordan KP, Hay EM. Low back pain symptoms show a similar pattern of improvement following a wide range of primary care treatments: a systematic review of randomized clinical trials. Rheumatology (Oxford). 2010;49:2346–56 23. Wang S-M, Harris RE., Lin Y-C, Gan TJ. Acupuncture in 21st century anesthesia: is there a needle in the haystack? Anesth Analg. 2013;116:1356–9 24. Lee A, Done ML. The use of nonpharmacologic techniques to prevent postoperative nausea and vomiting: a meta-analysis. Anesth Analg. 1999;88:1362–9 25. Lee A, Done ML. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2004:CD003281 26. Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2009:CD003281 27. Carlisle JB. A meta-analysis of prevention of postoperative nausea and vomiting: randomised controlled trials by Fujii etal. compared with other authors. Anaesthesia. 2012;67:1076–90 28. Sumikawa K. The results of investigation into Dr.Yoshitaka Fujii’s papers. Report of the Japanese Society of Anesthesiologists Special Investigation Committee. http://www.anesth.or.jp/english/pdf/news20120629.pdf 29. Bandolier. . Metoclopramide is ineffective in preventing postoperative nausea and vomiting. Available at: http://www.medicine.ox.ac.uk/bandolier/band71/b71-8.html. Accessed March 30, 2013 30. Henzi I, Walder B, Tramèr MR. Metoclopramide in the prevention of postoperative nausea and vomiting: a quantitative systematic review of randomized, placebo-controlled studies. Br J Anaesth. 1999;83:761–71 31. Hall H. Acupuncture’s claims punctured: not proven effective for pain, not harmless. Pain. 2011;152:711–2 32. Ioannidis JP. Why most published research findings are false. PLoS Med. 2005;2:e124 33. Simmons JP, Leif DN, Simonsohn U. False-positive psychology: undisclosed flexibility in data collection and analysis allows presenting anything as significant. Psychol Sci. 2011;22:1359–66 ### Follow-up 30 May 2013 Anesthesia & Analgesia has put the whole paper on line. No paywall now! 9 June 2013. Since this page was posted on May 30, it has had over 20,000 page views. Not bad. 26 July 2013. The Observer had a large double-page spread about acupuncture. It was written by David Derbyshire, largely on the basis of this article. 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. It’s hard to know what to make of David Tredinnick MP (Cons, Bosworth). He is certainly an extreme example of the scientific ignorance of our parliamentary representatives, but he isn’t alone in that. Our present minister of Education, Michael Gove, memorably referred to Newton’s Laws of Thermodynamics, blissfully unaware that thermodynamics was a 19th century development. And our present Minister of Health seems to think that magic water cures diseases. But Mr Treddinick breaks every record for anti-scientific nonsense. That, no doubt, is why he was upset by the recent revision of come NHS Choices web pages, so that they now give a good account of the evidence (that’s their job, of course). They did that despite two years of obstruction by the Department of Health. which seemed to think that it was appropriate to take advice from Michael Dixon of the Prince’s Foundation for integrated Health. That shocking example of policy based evidence was revealed on this blog, and caused something of a stir. Treddinick’s latest letter A copy of a letter from Mr Tredinnick to the Minister of Health, Jeremy Hunt, has some into my possession by a tortuous route [download the letter]. It’s a corker. Here are a few quotations. "1. UKIP moving onto our ground Attached is an extract from a recent UKIP policy statement. The position which UKIP has taken is one with which most of our Daily Mail reading supporters of complementary medicine would agree." It seems that Treddinick’s preferred authority on medicine is now Nigel Farage, leader of the UK’s far right party. UKIP’s policy on health is appended to the letter, and it’s as barmy as most of the other things they say. "2. Herbal Medicine . . .there is very real concern that the Government will not regulate Herbal Medicine and Traditional Chinese Medicine. The current situation is unacceptable, because herbal practitioners need regulation and cannot function as herbal therapists, nor can they cannot obtain stocks of their herbal remedies, without it. This refers to a saga that has been running for at least 10 years. Herbalists are desperate to get a government stamp of approval by getting statutory regulation, much like real doctors have, despite the fact that they make money by selling sick people "an unknown dose of an ill-defined drug, of unknown effectiveness and unknown safety" (as quoted recently in the House of Lords). Even the US National Center for Complementary and Alternative Medicine (NCCAM) doesn’t claim that a single herbal treatment is useful. The saga of herbal regulation is long and tedious. The short version is that a very bad report, The Pittilo report, recommended regulation of herbalists. After years of prevarication, Andrew Lansley ignored the impartial scientific advice and yielded to the pressure from the herbal industry to accept the Pittilo report. But still nothing has happened. Could it be that even Jeremy Hunt realises, deep down, that the regulation of nonsense is a nonsense that would harm the public? We can only hope that a letter from Mr Tredinnick is the kiss of death. Perhaps his continuous pestering will only reinforce the doubts that seem to exist at the Department of Health. Then Tredinnick returns (yawn) to his obsession with magic water. He vents his rage at the now excellent NHS Choices page on homeopathy. 3. Homeopathy "Recently this wording has been removed and instead a comment by the Chief Medical Officer that homeopathy is placebo inserted in its place, as well as links to external organisations which campaign against homeopathy. For instance, there is a link to the Sense About Science website, and Caroline Finucane, who is Editor of new content at NHS Choices, also writes for the Sense About Science website. This is an organisation which has no expertise in homeopathy and traces its roots back to the ultra-left Revolutionary Communist Party (RCP)." "I respectfully suggest that the original wording be reinstated and these links to external organisations be removed or changed to ensure a balanced view.". So it seems that he prefers the medical views of Nigel Farage and the Prince of Wales to those of the Chief Medical Officer and the government’s chief scientist. Disgracefully, Tredinnick picks out one particular employee of NHS Choices among many, and one who does an excellent job. And he raises the hoary old myth that Sense About Science is a communist organisation. Odd, since others accuse it of being neo-libertarian. The actual history is here. The organisation that is a bit too libertarian for my taste is Spiked Online. I haven’t agreed with every word that Sense about Science has printed, but they have a totally honest belief in evidence. To drag in the name of one person out of many, and to justify it by a false history shows, once again, how very venomous and vindictive the advocates of delusional medicine can be when they feel cornered. A bit more information about Mr Treddinick This is what the BBC News profile says about him.  David Tredinnick is an old style Conservative MP, being an Eton-educated former Guards officer, who has sat in the Commons since 1987. However, his ambition for high office was thwarted by his role in one of the sleaze stories which helped to sink the Major government. He accepted £1,000 from an undercover reporter to ask parliamentary questions about a fictitious drug. He was obliged to resign from his role as a PPS and was suspended from the Commons for 20 sitting days. He has not sat on the frontbench since. He is an orthodox Conservative loyalist, though he is more supportive of the European Union than many of his colleagues. He has, however, carved himself a niche as the Commons’ most enthusiastic supporter of complementary medicine. He has wearied successive health secretaries with his persistent advocacy of any and all homeopathic remedies. He has also supported their use in prisons and even suggested them as an aid in alleviating the foot and mouth crisis.  Tredinnick has also asserted that he was aware of a psychiatric hospital that doubled its staff at full moon (this is an old urban myth, and is, of course, quite untrue). His advocacy of homeopathic borax as a way to control the 2001 epidemic of foot and mouth diease can be read here. Luckily it was ignored by the government. I hope his latest letter will be treated similarly. Picture of David Tredinnick MP from the Conservative Party ### Follow-up Jump to follow-up 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 “Any advertising you undertake in relation to your professional activities must be accurate. Advertisements must not be misleading, false, unfair or exaggerated”. 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. Trading Standards offices and the Office of Fair Trading. 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). Astoundingly, Trading Standards officers refused to do anything about it. 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.” Jump to follow-up  This is a very important book. Buy it now (that link is to Waterstone’s Amazon don’t pay tax in the UK, so don’t use them). When you’ve read it, do something about it. The book has lots of suggestions about what to do. Stolen from badscience.net Peter Medawar, the eminent biologist, in his classic book Advice to a Young Scientist, said this. “Exaggerated claims for the efficacy of a medicament are very seldom the consequence of any intention to deceive; they are usually the outcome of a kindly conspiracy in which everybody has the very best intentions. The patient wants to get well, his physician wants to have made him better, and the pharmaceutical company would have liked to have put it into the physician’s power to have made him so. The controlled clinical trial is an attempt to avoid being taken in by this conspiracy of good will.” There was a lot of truth in that 1979, towards the end of the heyday of small molecule pharmacology. Since then, one can argue, things have gone downhill. First, though, think of life without general anaesthetics, local anaesthetics, antibiotics, anticoagulants and many others. They work well and have done incalculable good. And they were developed by the drug industry. But remember also that remarkably little is known about medicine. There are huge areas in which neither causes nor cures are known. Treatments for chronic pain, back problems, many sorts of cancer and almost all mental problems are a mess. It just isn’t known what to do. Nobody is to blame for this. Serious medical research has been going on for little more than 60 years, and it turns out to be very complicated. We are doing our best, but are still ignorant about whole huge areas. That leads to a temptation to make things up. Clutching at straws is very evident when it comes to depression, pain and Alzheimer’s disease, among others. In order to improve matters, one essential is to do fair tests on treatments that we have. Ben Goldacre’s book is a superb account of how this could be done, and how the process of testing has been subverted for commercial gain and to satisfy the vanities of academics. Of course there is nothing new in criticisms of Big Pharma. The huge fines levied on them for false advertising are well known. The difference is that Goldacre’s book explains clearly what’s gone wrong in great detail, documents it thoroughly, and makes concrete suggestions for improving matters. Big Pharma has undoubtedly sometimes behaved appallingly in recent years. Someone should be in jail for crimes against patients. They have behaved in much the same way that bankers have. In any huge globalised industry it is always possible to blame someone in another department for the dishonesty. But they aren’t the only people to blame. None of the problems could have arisen with the complicity of academics, universities, and a plethora of regulatory agencies and professional bodies. The biggest scandal of all is missing data (chapter 1). Companies, and sometmes academics, have suppressed of trials that don’t favour the drugs that they are trying to sell. The antidepressant drug, reboxetine, appeared at first to be good. It had been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and there was at least one good randomized placebo-controlled trial (RCT) showing it worked. But it didn’t. The manufacturer didn’t provide a complete list of unpublished trials when asked for them. After much work it was found in 2010 that, as well as the published, favourable trial, there were six more trials which had not been published and all six showed reboxetine to be no better than placebo . In comparisons with other antidepressant drugs three small studies (507 patients) showed reboxetine to be as good as its competitors. These were published. But it came to light that data on 1657 patients had never been published and these showed reboxetine to be worse than its rivals. When all the data for the SSRI antidepressants were unearthed (Kirsch et al., 2008) it turned out that they were no better than placebo for mild or moderate depression. This selective suppression of negative data has happened time and time again. It harms patients and deceives doctors, but, incredibly, it’s not illegal. Disgracefully, Kirsch et al. had to use a Freedom of Information Act request to get the data from the FDA. “The output of a regulator is often simply a crude, brief summary: almost a ‘yes’ or ‘no’ about side effects. This is the opposite of science, which is only reliable because everyone shows their working, explains how they know that something is effective or safe, shares their methods and their results, and allows others to decide if they agree with the way they processed and analysed the data.”  “the NICE document discussing whether it’s a good idea to have Lucentis, an extremely expensive drug, costing well over £ 1,000 per treatment, that is injected into the eye for a condition called acute macular degeneration. As you can see, the NICE document on whether this treatment is a good idea is censored. Not only is the data on the effectiveness of the treatment blanked out by thick black rectangles, in case any doctor or patient should see it, but absurdly, even the names of some trials are missing, preventing the reader from even knowing of their existence, or cross referencing information about them.Most disturbing of all, as you can see in the last bullet point, the data on adverse events is also censored.” The book lists all the tricks that are used by both industry and academics. Here are some of them. • Regulatory agencies like the MHRA, the European Medicines Agency (EMA) and the US Food and Drugs Administration (FDA) set a low bar for approval of drugs. • Companies make universities sign gagging agreements which allow unfavourable results to be suppressed, and their existence hidden. • Accelerated approval schemes are abused to get quick approval of ineffective drugs and the promised proper tests often don’t materialise • Disgracefully, even when all the results have been given to the regulatory agencies (which isn’t always). The MHRA, EMA and FDA don’t make them public. We are expected to take their word. • Although all clinical trials are meant to be registered before they start, the EMA register, unbelievably, is not public. Furthermore there is no check that the results if trials ever get published. Despite mandates that results must be published within a year of finishing the trial, many aren’t. Journals promise to check this sort of thing, but they don’t. • When the results are published, it is not uncommon for the primary outcome, specified before it started, to have been changed to one that looks like a more favourable result. Journals are meant to check, but mostly don’t. • Companies use scientific conferences, phony journals, make-believe “seed trials” and “continuing medical education” for surreptitious advertising. • Companies invent new diseases, plant papers to make you think you’re abnormal, and try to sell you a “cure”. For example, female sexual dysfunction , restless legs syndrome and social anxiety disorder (i.e. shyness). This is called disease-mongering, medicalisation or over-diagnosis. It’s bad. • Spin is rife. Companies, and authors, want to talk up their results. University PR departments want to exaggerate benefits. Journal editors want sensational papers. Read the results, not the summary. This is universal (but particularly bad in alternative medicine). • Companies fund patient groups to lobby for pills even when the pills are known to be ineffective. The lobby that demanded that Herceptin should be available to all on the breast cancer patients on the NHS was organised by a PR company working for the manufacturer, Roche. But Herceptin doesn’t work at all in 80% of patients and gives you at best a few extra months of life in advanced cases. • Ghostwriting of papers is serious corruption. A company writes the paper and senior academics appear as the authors, though they may never have seen the original data. Even in cases where academics have admitted to lying about whether they have seen the data, they go unpunished by their universities. See for example, the case of Professor Eastell. • By encouraging the funding of “continuing medical education” by companies, the great and the good of academic medicine have let us down badly. This last point is where the book ends, and it’s worth amplification. “So what have the great and good of British medicine done to help patients, in the face of this endemic corruption, and these systematic flaws? In 2012, a collaborative document was produced by senior figures in medicine from across the board, called ‘Guidance on Collaboration Between Healthcare Professionals and the Pharmaceutical Industry’. This document was jointly approved by the ABPI, the Department of Health, the Royal Colleges of Physicians, Nursing, Psychiatrists, GPs, the Lancet, the British Medical Association, the NHS Confederation, and so on. ” “It contains no recognition of the serious problems we have seen in this book. In fact, quite the opposite: it makes a series of assertions about them that are factually incorrect.” “It states that drug reps ‘can be a useful resource for healthcare professionals’. Again, I’m not sure why the Royal Colleges, the BMA, the Department of Health and the NHS Confederation felt the need to reassert this to the doctors of the UK, on behalf of industry, when the evidence shows that drug reps actively distort prescribing practices. But that is the battle you face, trying to get these issues taken seriously by the pinnacle of the medical establishment.” This is perhaps the most shameful betrayal of all. The organisations that should protect patients have sold them out. You may have been sold out by your “elders and betters”, but you can do something. The “What to do” sections of the book should be produced as a set of flash cards, as a reminder that matters can be improved. It is shameful that this book was not written by a clinical pharmacologist, or a senior doctor, or a Royal College, or a senior academic. Why has the British Pharmacological Society said nothing? It is shameful too that this book was not written by one of the quacks who are keen to defend the$60 billion alternative medicine industry (which has cured virtually nothing) and who are strident in their criticism of the 600 billion dollar Pharma industry.  They haven’t done the work that Goldacre has to analyse the real problems.  All they have done is to advocate unfair tests, because that is the only sort their treatments can pass.

It’s weird that medicine, the most caring profession, is more corrupt than any other branch of science.  The reason, needless to say, is money. Well, money and vanity.  The publish or perish mentality of senior academics encourages dishonesty. It is a threat to honest science.

Goldacre’s book shows the consequences: harm to patients and huge wastage of public money.

Do something.

### Follow-up

7 October, 2012, The Observer

Goldacre wrote

"I think it’s really disappointing that nobody, not the Royal Colleges, the Academy of Medical Sciences, the British Pharmacological Society, the British Medical Association, none of these organisations have stood up and said: selective non-publication of unflattering trial data is research misconduct, and if you do it you will be booted out. And I think they really urgently should."

Exactly.

Although many university courses in quackery have now closed, two subjects that hang on in a few places are western herbalism, and traditional Chinese medicine (including acupuncture). The University of Westminster still runs Chinese medicine, and Western herbal medicine (with dowsing). So do the University of Middlesex and University of East London.

Since the passing of the Health and Social Security Act, these people have been busy with their customary bait and switch tactics, trying to get taxpayers’ money. It’s worth looking again at the nonsense these people talk.

Take for example, the well known herbalist, Simon Mills. At one time he was associated with the University of Exeter, but no longer. Perhaps his views are too weird even for their Third Gap section (the folks who so misrepresented their results in a trial of acupuncture). Unsurprisingly, he was involved in the late Prince’s Foundation for Magic Medicine, and, unsurprisingly, he is involved with its successor, the "College of Medicine", where he spoke along similar lines. You can get a good idea about his views from the video of a talk that he gave at Schumacher College in 2005. It’s rather long, and exceedingly uncritical, so here’s a shorter version to which some helpful captions have been added.

That talk is weird by any standards. He says, apparently with a straight face, that "all modern medicines are cold in the third degree"..And with ginger and cinnamon "You can stop a cold, generally speaking, in its tracks" (at 21′ 30" in the video). This is simply not true, but he says it, despite the fact that the Plant Medicine with site (of which he’s a director) which he is associated gives them low ratings

Simon Mills is also a director of SustainCare. Their web site says

SustainCare Community Interest Company is a social enterprise set up to return health care to its owners: “learning to look after ourselves and our families in ways that make sense and do not cost the earth“. It is founded on the principle that one’s health is a personal story, and that illness is best managed when we make our health care our own. The enterprise brings clinical expertise, long experience of academia, education and business, and the connections and resources to deliver new approaches.

"As its own social enterprise contribution to this project Sustaincare set up and supported Café Sustain as a demonstration Intelligent Waiting Room at Culm Valley Integrated Centre for Health in Devon". (yes, that’s Michael Dixon, again]

In the talk (see video) Mills appears to want to take medicine back to how it was 1900 years ago, in the time of Galen. The oblique speaking style is fascinating. He never quite admits that he thinks all that nonsense is true, but presumably it is how he treats patients. Yet a person with these bizarre pre-scientific ideas is thought appropriate to advise the MHRA

It’s characteristic of herbalists that they have a very long list of conditions for which each herb is said to be good. The sort of things said by Mills differ little from the 1900-year old ideas of Galen, io the 17th century ideas of Culpepper.

You can see some of the latter in my oldest book, Blagrave’s supplement to Culpepper’s famous herbal, published in 1674.

See what he has to say about daffodils

It is "under the dominion of Mars, and the roots hereof are hot and dry almost in the third degree".

"The root, boyled in posset drink, and drunk, causeth vomiting, and is used with good successe in the beginning of Agues, especiallyTertians, which frequently rage in the spring-time: a plaister made of the roots with parched Barley meal, and applied to swellings and imposthumes do dissolve them; the juice mingled with hony, frankincense, wine and myrrhe, and dropped into the Eares, is good against the corrupt filth and running matter of the Eares; the roots made hollow and boyled in oyl doth help Kib’d heels [or here]: the juice of the root is good for Morphew, and discolourings of the skin."

It seems that daffodils would do a lot in 1674. Even herbalists don’t seem to use it much now. A recent herbal site describes daffodil as "poisonous".

But the descriptions are very like those used by present day herbalists, as you can hear in Simon Mills’ talk.

Chinese medicine is even less tested than western herbs. Not a single Chinese herb has been shown to be useful for treating anything (though in a very few case, they have been found to contain drugs that are useful when purified, notably the anti-malarial compound, artemesinin). They are often contaminated, some are dangerously toxic. And they contribute to the extinction of tigers and rhinoceros because of the silly myths that these make useful medicines. The cruelty of bear bile farming is legendary.

In a recent report in China Daily (my emphasis).

In a congratulation letter, Vice-Premier Li Keqiang called for integration of TCM and Western medicine.

TCM, as a time-honored treasure of Chinese civilization, has contributed to the prosperity of China and brought impacts to world civilization, Li said.

He also urged medical workers to combine the merits of TCM with contemporary medicine to better facilitate the ongoing healthcare reform in China.

The trade in Chinese medicines survives only for two reasons. One is that thay are a useful tool for promoting Chinese nationalism. The other is that they are big business. Both are evident in the vice-premier’s statement.

I presume that it’s the business bit that is the reason why London South Bank University (ranked 114 ou ot 114) that led to one of their main lecture theatres being decorated with pictures like this.“Mr Li Changchun awarding 2010 Confucius Institute of the year to LSBU Vice Chancellor” . I’ll bet Mr Li Changchun uses real medicine himself, as most Chinese who can afford it do.

Presumably, what’s taught in their Confucius Institute is the same sort of dangerous make-believe nonsense.that’s taught on other such courses.

The "College of Medicine" run a classical bait and switch operation. Their "First Thursday lectures" have several good respectable speakers, but then they have Andrew Flower, He is "a former president of the Register of Chinese Herbal Medicine, a medical herbalist and acupuncturist. He has recently completed a PhD exploring the role of Chinese herbal medicine in the treatment of endometriosis". He’s associated with the Avicenna Centre for Chinese Medicine, and with the University of Southampton’s quack division The only bit of research I could find by Andrew Flower was a Cochrane review, Chinese herbal medicine for endometriosis. The main results tell us

"Two Chinese RCTs involving 158 women were included in this review. Both these trials described adequate methodology. Neither trial compared CHM with placebo treatment."

But the plain language summary says

"This review suggests that Chinese herbal medicine (CHM) may be useful in relieving endometriosis-related pain with fewer side effects than experienced with conventional treatment."

It sounds to me as though people as partisan as the authors of this should not be allowed to write Cochrane reviews.

Flower’s talk is followed by one from the notorious representative of the herbal industry, Michael McIntyre, talking on Herbal medicine: A major resource for the 21st century. That’s likely to be about as objective as if they’d invited a GSK drug rep to talk about SSRIs.

The people at Kings College London Institute of Pharmaceutical Sciences are most certainly not quacks. They have made a database of chemicals found in traditional Chinese medicine. It’s sold by a US company, Chem-TCM and it’s very expensive (Commercial license: $3,740.00. Academic/government license:$1,850.00). Not much open access there. It’s a good idea to look at chemicals of plant origin, but only as long as you don’t get sucked into the myths. It’s only too easy to fall for the bait and switch of quacks (like TCM salespeople). The sample page shows good chemical and botanical information, and predicted (not observed) pharmacological activity. More bizarrely, it shows also analysis of the actions claimed by TCM people.

It does seem odd to me to apply sophisticated classification methods to things that are mostly myth.

The multiple uses claimed for Chinese medicines are very like the make-believe claims made for western herbs by Galen, Culpepper and (with much less excuse) by Mills.

They are almost all untrue, but their proponents are good salesmen. Don’t let them get a foot in your door.

### Follow-up

10 June 2012. No sooner did this post go public when I can across what must be one of the worst herbal scams ever: “Arthroplex

31 July 2012. Coffee is the subject of another entry in the 1674 edition of Blagrave.

Blagrave evidently had a lower regard for coffee than I have.

“But being pounded and baked, as do it to make the Coffee-liquor with, it then stinks most loathsomly, which is an argument of some Saturnine quality in it.”

“But there is no mention of an medicinal use thereof, by any Author either Antient of Modern”

Blagrave says also

“But this I may truly say of it [coffee]: Quod Anglorum Corpora quae huic liquori, tantopere indulgent, in Barbarorum naturam degenerasse videntur,”

This was translated expertly by Benet Salway, of UCL’s History department

“that the bodies of the English that indulge in this liquor to such an extent seem to degenerate into the nature of barbarians”

My boss, Lucia Sivolotti got something very like that herself. Be very impressed.

Salway suggested that clearer Latin would have been “quod corpora Anglorum, qui tantopere indulgent huic liquori, degenerasse in naturam barbarorum videntur”.

I’d have passed that on to Blagrave, but I can’t find his email address.

I much prefer Alfréd Rényi’s aphorism (often misattributed to Paul Erdös)

“A mathematician is a machine for turning coffee into theorems”

Our undercover investigation finds evidence of nutritional therapists giving out advice that could seriously harm patients’ health

That’s the title of an article in February’s Which? magazine. (That’s similar to Consumer Reports in the USA).

“When Which? sent researchers to investigate the quality of advice from nutritional therapists, some was so bad that patients’ health was put at risk. One nutritional therapist advised against surgery and radiotherapy to treat cancer, while another ‘diagnosed’ a problem with adrenal glands without any blood-test results. Some also used unproven testing, such as iridology or mineral testing, to identify problems or diagnose conditions.”

 This sort of sting operation may seem a bit mean but there is no option. It’s the only way to discover what’s actually happening and it is very much in the public interest to know about that. "Our panel of medical experts rated six of our 15 consultations as ‘dangerous fails’ – potentially endangering the health of our researchers – with a further eight rated as ‘fails’. Only one consultation of the 15 was deemed a borderline pass by our experts.”

"We sent five undercover researchers to visit three nutritional therapists each. Every researcher was equipped with a specific health-related scenario: Helen (46) and Sarah (40), recently diagnosed with Ductal Carcinoma In Situ (DCIS), the most common type of non-invasive breast cancer; Mark (56) and Linda (52), suffering with serious fatigue for the past three months; and Emily (31), trying unsuccessfully to conceive for more than a year."

 Sarah, posing as a patient diagnosed with DCIS, visited a nutritional therapist who advised her to delay treatment recommended by her oncologist (a lumpectomy and a course of radiotherapy). The therapist suggested that Sarah follow a no-sugar diet for three to six months and told her, ‘cancer lives off sugar; if you feed it sugar it’s going to thrive. If we starve the cancer of sugar then you have a better opportunity of the cancer going away’. When Sarah asked whether the cancer could progress during this time the therapist said it was a ‘gamble’. Dr Margaret McCartney, from our panel of experts, says: ‘If cancer treatment were as simplistic as cutting out sugar, surely we would have discovered a cure. This advice is highly irresponsible.’ Our experts rated this consultation as a ‘dangerous fail’." The Patients’ Guide to magic medicine defined “Nutritional therapy: self-styled ‘nutritionists’ making untrue claims about diet in order to sell you unnecessary supplements”. That turned out to be pretty accurate. They are part of the alternative medicine fringe. The Universities Admission Service (UCAS) no longer lists any BSc/MSc degrees in "Nutritional Therapy" or "Nutritional medicine". Westminster University closed its BSc Nutritional Therapy during last year. We still don’t know the fate of the notorious (or should I say hilarious) course run at the Northern College of Acupuncture and validated (after a fashion) by the late University of Wales, but it isn’t listed for entry in 2012. [We do now: see follow-up‘] But there are a large number of university courses called "Nutrition". How many of them teach properly, and how many of them teach the nonsense that prevails in "nutritional therapy", I don’t know. The term ‘nutrition’ has turned into a dangerous minefield. It can mean almost anything, because the term is undefined. Anyone can, and does, describe themselves as a nutritionist. At one extreme you have slick pills salesman like ‘not-a-Dr’ Gillian McKeith and Patrick Holford. At the other extreme you have a fascinating and respectable subject for study. The one thing that you need to get clear is that if you want advice about nutrition, go to a dietitian not a "nutritionist". Dietitians are the properly qualified people who work in the NHS, and who are (mostly) free of crackpot ideas.

I suppose that one should not be surprised at the poor, and sometimes dangerous, advice that was given by nutritional therapists. Their training contains much nonsense so it isn’t surprising that they did so badly. Some of it has been revealed here. See, for example,

The level of knowledge of both physiology and chemistry shown my some of the therapists was shocking. One recommended avoiding margarine, because it’s “two chemical bonds away from pure plastic”. Another said that Flora margarine contains lots of trans fat, which has not been true for a long time.

One graduate ot the late Thames Valley University course said “”advantage of the wholemeal or the wholegrain … is that they contain more fibre and the fibre stops the sugars being absorbed quite as quickly”. Not so. Brown and white bread have much the same glycaemic index (60 – 70).

Quack diagnosis

One alarming fact was that several therapists offered methods of diagnosis for allergy and for deficiencies that have been known for many years not to work. There isn’t anything controversial about iridology, hair mineral analysis, taste tests. kinesiology. or the Vega test. They are pure quackery.

“Professor David Colquhoun, from our panel of experts, said: ‘Sadly, nutritional therapy is plagued by “diagnostic tests” that are little more than quackery; they are tools to aid sales, rather than tools to diagnose deficiencies. Iridology and hair analysis simply don’t work.”

Unnecessary treatments

One therapist advised a researcher to have an optimum nutritional evaluation test, costing £312, and a cellular nutrition profile, costing £156. Apparently, these would allow the therapist to give a
more targeted service by establishing what vitamin and mineral deficiencies he had.
Our experts were not convinced by these tests and certainly didn’t think they were worth the money; any necessary testing

In 12 of the 15 consultations, researchers were prescribed a huge range of supplements, costing up to £70 per month. It was not revealed whether or not the prescriber made money from this, but usually you were asked to give the prescriber’s name "to get a discount". So it’s a fair guess that they got kickbacks.

British Association for Applied Nutrition & Nutritional Therapy (BANT)

Despite the low standards of advice, 13 out of the 14 therapists who were visited were registered with BANT, the British Association for Applied Nutrition & Nutritional Therapy. This is what passes for a professional association for nutritional therapists, though like all such bodies in alternative medicine, it is entirely ineffective as a regulator. Rather it serves to protect whatever untrue claims they make. BANT’s code of practice says that its members won’t diagnose, but in fact many of the therapists diagnosed conditions and created treatment plans. You can be confident that BANT will do nothing to stop this bad practice.

You can find out a lot about BANT from these sources:

Only 3 of the 14 therapists were registered with the Complementary and Natural Healthcare Council (the CNHC, more commonly know as Ofquack). They are meant to be the official regulator, launched with a good chunk of taxpayers’ money, but registration is voluntary and not many have volunteered. As a requlator, Ofquack is a bad joke.

Conclusion

 "Dr Margaret McCartney says: ‘This investigation appears to show that high street nutritional therapists are a waste of money. If you have symptoms please see your GP, not someone who can’t diagnose accurately.’ If you’re looking for tailored dietary advice, visit a registered dietitian. "

There is a discussion of this topic on the Which? magazine site.

### Follow-up

The excellent Quackometer has posted simultaneously on the great nutritional therapy scam.

16 January 2012 The British Dietetic Association issued a press release that describes very clearly the many differences between a real dietitian and a "nutritional therapist". Download Leading UK Nutrition Association Urges Awareness Between Dietitians and Nutritionists (pdf).

16 January 2012 BANT issued a press release. Download Are Nutritional Therapists Gambling with Your Health?. It answers none of the serious questions raised by the Which? investigation.   BANT moans that that Which?  “did not provide all the promised transcripts/questionnaires in a timely fashion”.   In fact they got them before Christmas and were given until January 15th to respond.

16 January 2012. BBC Radio 4 programme, You and Yours, had an item with Jenny Driscoll from Which? magazine and BANT chairperson, Catherine Honeywell. She did, inter alia, admit that some of the behaviour of the therapists were irresponsible. It remains to be seen if they do anything about it. don’t hold your breath. Hear it on BBC iPlayer.

16 January 2012. There was pretty god coverage of the story, even in the Daily Mail.

17 January 2012 Another question answered. I just learned that the ludicrous course in Nutritional Therapy, previously validated by the University of Wales (and a contributor to its downfall), is now being validated by, yes, you guessed, Middlesex University. Professor Driscoll seems determined to lead his univerity to the bottom of the academic heap. His new partnership with the Northern college of Acupuncture is just one of a long list of validations that almost rivals that of the late University of Wales. The course has, of course, an enthusiastic testimonial, from a student. It starts

I work full time as a team leader for a pension company but I am also a kinesiologist and work in my spare time doing kinesiology, reiki and Indian head massage.

Evidently she’s a believer in the barmiest and totally disproved forms of magic medicine. And Middlesex University will give her a Master of Science degree. I have to say I find it worrying that she’s a team leader for a pension company. Does she also believe in the value of worthless derivatives. I wonder?

17 January 2012 The discussion is going on at the Which? web site. A Chris James cast doubt on the reaults because ot the small sample size, and asked for confidence limits, so I gave them.

Chris James

It is easy enough to calculate limits yourself -you don’t even need to be able to do the maths -there are web calculators that do it for you, e.g. http://www.causascientia.org/math_stat/ProportionCI.html

14/15 = 93% failed. 95% confidence limits for this are 69.8% to 98.4%

6/15 = 40% gave dangerous advice 95% confidence limits 19.7% to 64.6%

So despite the small sample size we can say that it’s likely that at least 70% (and possibly 98%) of nutritional therapists fail.

And it is likely that at least 20% (and possibly 65%) of nutritional therapists give dangerous advice.

These results give real cause for concern, despite the small sample size.

For statistical enthusiasts, these limits are Bayesian with a uniform prior. Very much the same result is given by the standard analysis which is explained in section 7.7 of Lectures on Biostatistics [download pdf 10.5 Mb]

18 January 2012. BANT has, at last, produced an “updated response”. The good thing is that it starts by saying

” . . it is completely outside the BANT Code of Practice to advise a client to withhold any treatment for cancer for any period of time in order to follow a nutritional approach. Were a client to be advised in such a way we would expect to receive a complaint against the practitioner.”

I hope that this will happen. This statement, the only admission of guilt in BANT’s response, is rather spoiled by a later suggestion that no such recommendation was made. It looked very clear to both Which? magazine and to the three members of the expert panel.

The rest of the response admits no fault of any sort.

I’m sorry to say that the response by BANT shows very clearly what is wrong in nutritional therapy. Any organisation which can see nothing wrong in the advice given in 14 of the 15 consultations is, I’d argue, a threat to the health of the nation. Rather than saying we’ll try to improve, they just deny everything.

The response seems to show that the professional organisation for nutritional therapists is not part of the solution. Rather it is part of the problem.

Since writing about anti-scientific degrees in Nature (March 2007), much has been revealed about the nonsense that is taught on these degrees. New Year’s day seems like a good time to assess how far we’ve got, five years on.

At the beginning of 2007 UCAS (the universities central admission service) offered 45 different BSc degrees in quackery, at 16 universities.

Now there are only 24 such degrees.

If you exclude chiropractic and osteopathy, which all run at private colleges, with some sort of "validation" from a university, there are now only 18 BSc/MSc courses being offered in eight universities.

Degrees in homeopathy, naturopathy and "nutritional therapy", reflexology and aromatherapy have vanished altogether from UCAS.

In the race to provide BScs in anti-science, Middlesex University has now overhauled the long-standing leader, Westminster, by a short head.

 Michael Driscoll, vice-chancellor of Middlesex Geoffrey Petts, vice-chancellor of Westminster

Let’s see what’s gone.

The University of Central Lancashire (UCLAN) was the first to see sense. In August 2008 they announced closure of their “BSc” degree in homeopathy. On September 2008 they announced an internal review of their courses in homeopathy. herbalism and acupuncture. The report of this review closed down all of them in July 2009. I first asked for their teaching materials in July 2006. I finally got them in December 2010, after winning an appeal to the Information Commissioner, and then winning an appeal against that decision at an Information tribunal . By the time I got them, the course had been closed for over two years. That is just as well, because it turned out that UCLAN’s students were being taught dangerous nonsense. No wonder they tried so hard to conceal it.

Salford University was the next to go. They shut down their courses in complementary medicine, homeopathy and acupuncture. In January 2009 they announced " they are no longer considered “a sound academic fit” ". Shortly afterwards. a letter appeared in The Times from three heavyweights (plus me) congratulating the vice-chancellor on his decision.

University of Westminster

For many years, Westminster was the biggest supplier of BSc degrees in quackery. At the beginning of 2007 they offered 14 different BSc degrees in homeopathy, naturopathy, nutritional therapy, "complementary therapies", (western) herbal medicine and traditional Chinese medicine with acupuncture. Some of their courses were so bizarre that some of the students and even staff sent me slides which taught things like "amethysts emit high Yin energy". Like UCLAN, Westminster also held an internal review. Unlike UCLAN it came to the absurd conclusion that all would be well if they injected more science into the courses. The incompetence of the review meant that those who wrote it hadn’t noticed that if you try to put science into homeopathy or naturopathy, the whole subject vanishes in a puff of smoke. Nevertheless Westminster closed down entry to BSc homeopathy in March 2009 (though the subject remained as part of other courses).

Three years after the Nature article, all five BSc homeopathy degrees had shut their doors.

During 2011, Westminster shut down Naturopathy, Nutritional therapy, Therapeutic bodywork and Complementary Medicine. See, for example,
More dangerous nonsense from the University of Westminster: when will Professor Geoffrey Petts do something about it?

University of Westminster shuts down naturopathy, nutritional therapy, but keeps Acupuncture and Herbal Medicine

Now Westminster has only four courses in two subjects. They still teach some dangerous and untrue things, but I suspect the writing is on the wall for these too.

I have seen a document, dated 11 April 2011, which states

“The following courses have been identified as ‘at risk’ (School definition) and will be discussed at the APRG and University Review Group2, due to poor recruitment and high cost of delivery:
 Integrated Health Scheme: BSc Complementary Medicine, Naturopathy; BSc Chinese Medicine; BSc Nutritional Therapy; BSc Herbal Medicine”

All but Chinese medicine and Herbal medicine have already gone. Almost there.

University of Wales

Since my first post in 2008 about the validation scam operated by the University of Wales, and some good investigations by BBC Wales TV, the outcome was the most spectacular so far. The entire institution collapsed. They no longer "validate" external degrees at dodgy business colleges, loony religious colleges or magic medicine colleges.

Another worthless validation: the University of Wales and nutritional therapy (October 2008) This is a ‘degree’ in nutrtional therapy. It is even more hilarious than usual, but it passed the validation anyway.

Scandal of the University of Wales and the Quality Assurance Agency (November 2010). This post followed the BBC Wales TV programme. At last the QAA began to notice, yet further confirmation of its utter ineptitude.

The University of Wales disgraced (but its vice chancellor is promoted) (October, 2011) The eventual collapse of the university was well-deserved. But it is very weird that the people who were responsible for it have still got their jobs. In fact the vice-chancellor, Marc Clement, was promoted despite his mendacious claim to be unaware of what was going on.

It remains to be seen how many of the many quack courses that were validated by the University of Wales will be taken on by other universities. The McTimoney College of Chiropractic is owned by BPP University (so much for their quality control, as explained in Private Eye). but still claims to be validated by Wales until 2017.

Some of the more minor players

Edinburgh Napier University. After an FOI request (rejected), Napier closed their herbal medicine degree in 2010.

As expected, the Scottish Information Commissioner agreed with that for England and Wales and ordered material to be sent. Edinburgh Napier University teaches reflexology, aromatherapy and therapeutic touch. Scottish Information Commissioner says you should know. Some of the horrors so discovered appeared in Yet more dangerous nonsense inflicted on students by Edinburgh Napier University. The embarrassment seems to have worked. Their remaining degrees in aromatherapy and reflexology have now vanished from UCAS too. All that remains is a couple of part time “Certificates of Credit” for aromatherapy and reflexology

Anglia Ruskin Univerity Not only have BSc degrees gone in aromatherapy and reflexology, but their midwifery degree now states "We are unable to accept qualifications in aromatherapy, massage and reflexology."

University of Derby Reflexology and aromatherapy have gone, though doubtless Spa management therapies have much nonsense left

University of Greenwich. BSc in Complementary Therapies (Nutritional Health) and BSc in Complementary Therapies (Nutritional Health) have been shut. The BSc Acupuncture is listed on their web site but it is under review, and is not listed in UCAS for 2012. (Acupuncture is run at International College of Oriental medicine, validated by Greenwich.). Only osteopathy (MOst) is still running, and that is a validation of an external course run at The European School of Osteopathy, in Maidstone

Thames Valley University was renamed the University of West London in 2010. The nonsense that was run there (e.g. Nutritional Fairy Tales from Thames Valley University) seems to have vanished. Their previous alt med guru, Nicola Robinson, appears now to be at London South Bank University (ranked 116 out of the 116 UK universities)

### What’s left?

Chiropractic Surprisingly, given the total discreditation of chiropractic in the wake of the Simon Singh affair, and the internecine warfare that followed it, none of the chiropractic courses have shut yet. Some are clearly in trouble, so watch this space.

Osteopathy has also had no course closures since 2007. Like chiropractic it also suffers from internecine warfare. The General Osteopathic Council refuses to disown the utter nonsense of "craniosacral" osteopathy. But the more sensible practitioners do so and are roughly as effective as physiotherapists (though there are real doubts about how effective that is).

Excluding chiropractic and osteopathy, this is all that’s left. It now consists almost entirely of Chinese medicine and a bit of herbal.

Glyndwr university (Known as North East Wales Institute until 2008)   Ranked 104 out of 116 UK universities

BSc Acupuncture (B341) BSc
BSc Complementary Therapies for Healthcare (B343)

Cardiff Metropolitan University (UWIC) (Known as University of Wales Institute Cardiff (UWIC) until Nov 2011.)   The vice-chancellor of Cardiff Metropolitan, Antony Chapman, is in the QAA’s board of directors, so perhaps it isn’t surprising that the QAA has done nothing.

BSc Complementary Therapies (3 years) (B390)
BSc Complementary Therapies (4 yrs inc Foundation) (B300)

University of Lincoln

Acupuncture (B343) 3FT Hon BSc
Herbal Medicine (B342) 3FT Hon BSc

University of East London   Ranked 113 out of 116 UK universities

Acupuncture (B343) 3FT Hon BSc

London South Bank University   Ranked 116 out of 116 UK universities

Acupuncture (B343) 4FT Deg MCM

The Manchester Metropolitan University   Ranked 93 out of 116 UK universities

Acupuncture (B343) 3FT Hon BSc

Middlesex University

Acupuncture (B348) 3FT Hon BSc
Ayurvedic Medicine (A900) 4FT Oth MCM
Herbal Medicine (B347) 3FT Hon BSc
Traditional Chinese Medicine (BT31) 4FT Hon BSc

University of Westminster

Chinese Medicine: Acupuncture (B343) 3FT Hon BSc
Chinese Medicine: Acupuncture with Foundation (B341) 4FT/5FT Hon BSc/MSci
Herbal Medicine (B342) 3FT Hon BSc
Herbal Medicine with Foundation Year (B340) 4FT/5FT Hon BSc/MSci

It seems that acupuncture hangs on in universities that are right at the bottom of the rankings.

Manchester Metropolitan gets the booby prize for actually starting a new course, just as all around are closing theirs. Dr Peter Banister, who was on the committee that approved the course (but now retired), has told me ” I am sceptical in the current economic climate whether it will prove to be successful”. Let’s hope he’s right.

But well done Westminster. Your position as the leader in antiscientific degrees has now been claimed by Middlesex University. Their "degrees" in Ayurveda mark out Middlesex University as the new King of Woo.

Over to you, Professor Driscoll. As vice-chancellor of Middlesex University, the buck stops with you.

Both still teach Chinese and herbal medicine, which are potentially dangerous. There is not a single product from either that has marketing authorisation from the MHRA, though the MHRA has betrayed its trust by allowing misleading labelling of herbal medicines without requiring any evidence whatsoever that they work, see, for example

Sub-degree courses

In contrast to the large reduction in the number of BSc and MSc degrees, there has actually been an increase in two year foundation degrees and HND courses in complementary medicine, at places right near the bottom of the academic heap. The subject is sinking to the bottom. With luck it will vanish entirely from universities before too long.

Research-intensive Universities

Although all of the degrees in magic medicine are from post-1992 universities, the subject has crept into more prestigious universities. Of these, the University of Southampton is perhaps the worst, because of the presence of George Lewith, and his defender, Stephen Holgate. Others have staunch defenders of quackery, including the University of Warwick, University of Edinburgh and St Batholomew’s.

### Why have all these courses closed?

One reason is certainly the embarrassment caused by exposure of what’s taught on the courses. Professors Petts (Westminster) and Driscoll (Middlesex) must be aware that googling their names produces references to this and other skeptical blogs on the front page. Thanks to some plain brown emails, and, after a three year battle, the Freedom of Information Act, it has been possible to show here the nonsense that has been foisted on students by some universities. Not only is this a burden on the taxpayer, but, more importantly, some of it is a danger to patients.

When a course closes, it is often said that it is because of falling student numbers (though UCLAN and Salford did not use that excuse). Insofar as that is true, the credit must go to the whole of the skeptical movement that has grown so remarkably in the last few years. Ben Goldacre’s "ragged band of bloggers" have produced a real change in universities and in society as a whole.

The people who should have done the job have either been passive or an active hindrance. The list is long. Vice-chancellors and Universities UK (UUK), the Quality Assurance Agency (QAA), the Hiigher Education Funding Council England (HEFCE), Skills for Health, the Medicines and Health Regulatory Authority ( MHRA) , the Health Professions Council (HPC), the Department of Health, the Prince of Wales and his reincarnated propaganda organisation, the "College of Medicine", the King’s Fund, the Universities and Colleges Union (UCU), OfQual, Edexcel, National Occupational Standards and Qualifications and the Curriculum Authority (QCA).

Whatever happened to that "bonfire of the quangos"?

### Follow-up

2 January 2012 The McTimoney College of Chiropractic (owned by BPP University) claims that its “validation” by the University of Wales will continue until 2017. This contradicts the statement from UoW. Watch this space.

3 January 2012. Thanks to Neil O’Connell for drawing my attention to a paper in Pain. The paper is particularly interesting because it comes from the Southampton group which has previously been sympathetic to acupuncture. Its authors include George Lewith. It shows, yet again that there is no detectable difference between real and sham acupuncture treatment. It also shows that the empathy of the practitioner has little effect: in fact the stern authoritarian practitioner may have been more effective.

Patients receiving acupuncture demonstrated clinically important improvements from baseline (i.e., a 29.5% reduction in pain), but despite this, acupuncture has no specific efficacy over placebo for this group of patients. The clinical effect of acupuncture treatment and associated controls is not related to the use of an acupuncture needle, nor mediated by empathy, but is practitioner related and may be linked to the perceived authority of the practitioner.”

Sadly. the trial didn’t include a no-treatment group, so it is impossible to say how much of the improvement is regression to the mean and how much is a placebo effect. The authors admit that it could be mostly the former.

Surely now the misplaced confidence in acupuncture shown by some medical and university people must be in tatters.

In yet another sign that even acupuncture advovates are beginning to notice that it doesn’t work, a recent article Paradoxes in Acupuncture Research: Strategies for Moving Forward, shows some fascinating squirming.

3 January 2012.  The Daily Telegraph has carried a piece about closure of university courses, written by Michael Hanlon. On 31 January they carried a much longer piece.

3 January 2012.  It is a great pity that some physiotherapists seem to have fallen hook, line and sinker for the myths of acupuncture. Physiotherapists are, by and large, the respectable face of manipulative therapy. Their evidence base is certainly not all one would wish, but at least they are free of the outrageous mumbo humbo of chiropractors. Well, most of them are, but not the Acupuncture Association of Chartered Physiotherapists (AACP), or, still worse, The Association of Chartered Physiotherapists in Energy Medicine, a group that is truly away with the fairies. These organisations are bringing a very respectable job into disrepute. And the Health Professions Council, which is meant to be their regulator, has, like most regulators, done nothing whatsoever to stop it.

5 January 2012. Times Higher Education gives a history of the demise of the University of Wales, Boom or Bust. It’s a useful timeline, but like so many journalists, it’s unwilling to admit that bloggers were on to the problem long before the BBC, never mind the QAA.

There was also a leader on the same topic, Perils of the export business. It again fails to take the QAA to task for its failures.

Interviews for Deutsche Welle and Middle East Broadcasting Center TV.

17 January 2012 Another question answered. I just learned that the ludicrous course in Nutritional Therapy, previously validated by the University of Wales (and a contributor to its downfall), is now being validated by, yes, you guessed, Middlesex University. Professor Driscoll seems determined to lead his univerity to the bottom of the academic heap. His new partnership with the Northern college of Acupuncture is just one of a long list of validations that almost rivals that of the late University of Wales. The course has, of course, an enthusiastic testimonial, from a student. It starts

I work full time as a team leader for a pension company but I am also a kinesiologist and work in my spare time doing kinesiology, reiki and Indian head massage.

Evidently she’s a believer in the barmiest and totally disproved forms of magic medicine. And Middlesex University will give her a Master of Science degree. I have to say I find it worrying that she’s a team leader for a pension company. Does she also believe in the value of worthless derivatives. I wonder?

18 January 2012. the story has gone international, with an interview that I did for Deutsche Welle, UK universities drop alternative medicine degree programs. I’m quoted as saying “They’re dishonest, they teach things that aren’t true, and things that are dangerous to patients in some cases”. That seems fair enough.

There is also an interesting item from July 2010 about pressure to drop payment for homeopathy by German health insurance

31 January 2012

The Daily Telegraph carried a prominent 1200 word account (the title wasn’t mine). The published version was edited slightly.

Almost all the revelations about what’s taught on university courses in alternative medicine have come from post-1992 universities. (For readers not in the UK, post-1992 universities are the many new univerities created in 1992, from former polytechnics etc, and Russell group universities are the "top 20" research-intensive universities)

It is true that all the undergraduate courses are in post-1992 universities, but the advance of quackademia is by no means limited to them. The teaching at St Bartholomew’s Hospital Medical School, one of the oldest, was pretty disgraceful for example, though after protests from their own students, and from me, it is now better, I believe.

Quackery creeps into all universities to varying extents. The good ones (like Southampton) don’t run "BSc" degrees, but it still infiltrates through two main sources,

The first is via their HR departments, which are run by people who tend to be (I quote) "credulous and moronic" when it comes to science.

The other main source is in teaching to medical students. The General Medical Council says that medical students must know something about alterantive medicine and that’s quite right, A lot of their patients will use it. The problem is that the guidance is shockingly vague .

“They must be aware that many patients are interested in and choose to use a range of alternative and complementary therapies. Graduates must be aware of the existence and range of such therapies, why some patients use them, and how these might affect other types of treatment that patients are receiving.” (from Tomorrow’s Doctors, GMC)

In many medical schools, the information that medical students get is quite accurate. At UCL and at King’s (London) I have done some of the familiarisation myself. In other good medical schools, the students get some shocking stuff. St Bartholomew’s Hospital medical School was one example. Edinburgh University was another.
But there is one Russell group university where alternative myths are propagated more than any other that I know about. That is the University of Southampton.

In general, Southampton is a good place, I worked there for three years myself (1972 – 1975). The very first noise spectra I measured were calculated on a PDP computer in their excellent Institute of Sound and Vibration Research, before I wrote my own programs to do it.

But Southanpton also has a The Complementary and Integrated Medicine Research Unit . Oddly the unit’s web site, http://www.cam-research-group.co.uk, is not a university address, and a search of the university’s web site for “Complementary and Integrated Medicine Research Unit” produces no result. Nevertheless the unit is “within the School of Medicine at the University of Southampton”

Notice the usual euphemisms ‘complementary’ and ‘integrated’ in the title: the word ‘alternative’ is never used. This sort of word play is part of the bait and switch approach of alternative medicine.

The unit is quite big: ten research staff, four PhD students and two support staff It is headed by George Lewith.

### Teaching about alternative medicine to Southampton medical students.

The whole medical class seems to get quite a lot compared with other places I know about. That’s 250 students (210 on the 5-year course plus another 40 from the 4-year graduate-entry route).

Year 1:  Lecture by David Owen on ‘holism’ within the Foundation Course given to all 210 medical students doing the standard (5-year) course.

Year 2: Lecture by Lewith (on complementary medicine, focusing on acupuncture for pain) given within the nervous systems course to the whole medical student year-group (210 students).

Year 3 SBOM (scientific basis of medicine) symposium: The 3-hour session (“Complementary or Alternative Medicine: You Decide”). I’m told that attendance at this symposium is often pretty low, but many do turn up and all of them are officially ‘expected’ to attend.

There is also an optional CAM special study module chosen by 20 students in year 3, but also a small number of medical students (perhaps 2 – 3 each year?) choose to do a BMedSci research project supervised by the CAM research group and involving 16-18 weeks of study from October to May in Year 4. The CAM research group also supervise postgraduate students doing PhD research.

As always, a list of lectures doesn’t tell you much. What we need to know is what’s taught to the students and something about the people who teach it. The other interesting question is how it comes about that alternative medicine has been allowed to become so prominent in a Russell group university. It must have support from on high. In this case it isn’t hard to find out where it comes from. Here are some details.

Year 1 Dr David Owen

David Owen is not part of Lewith’s group, but a member of the Division of Medical Education headed by Dr Faith Hill (of whom, more below). He’s one of the many part-time academics in this area, being also a founder of The Natural Practice .

Owen is an advocate of homeopathy (a past president of the Faculty of Homeopathy). Homeopathy is, of course, the most barmy and discredited of all the popular sorts of alternative medicine. Among those who have discredited it is the head of the alt med unit, George Lewith himself (though oddly he still prescribes it).

And he’s also a member of the British Society of Environmental Medicine (BSEM). That sounds like a very respectable title, but don’t be deceived. It is an organisation that promotes all sorts of seriously fringe ideas. All you have to do is notice that the star speaker at their 2011 conference was none other than used-to-be a doctor, Andrew Wakefield, a man who has been responsible for the death of children from measles by causing an unfounded scare about vaccination on the basis of data that turned out to have been falsified. There is still a letter of support for Wakefield on the BSEM web site.

The BSEM specialises in exaggerated claims about ‘environmental toxins’ and uses phony allergy tests like kinesiology and the Vega test that misdiagnose allergies, but provide en excuse to prescribe expensive but unproven nutritional supplements, or expensive psychobabble like "neuro-linguistic programming".

Other registered "ecological physicians" include the infamous Dr Sarah Myhill, who, in 2010, was the subject of a damning verdict by the GMC, and Southampton’s George Lewith.

If it is wrong to expose medical students to someone who believes that dose-response curves have a negative slope (the smaller the dose the bigger the effect -I know, it’s crazy), then it is downright wicked to expose students to a supporter of Andrew Wakefield.

David Owen’s appearance on Radio Oxford, with the indomitable Andy Lewis appears on his Quackometer blog.

Year 2 Dr George Lewith

Lewith is a mystery wrapped in an enigma. He’s participated in some research that is quite good by the (generally pathetic) standards of the world of alternative medicine.

In 2001 he showed that the Vega test did not work as a method of allergy diagnosis. "Conclusion Electrodermal testing cannot be used to diagnose environmental allergies", published in the BMJ .[download reprint].

In 2003 he published "A randomized, double-blind, placebo-controlled proving trial of Belladonna 30C” [download reprint] that showed homeopathic pills with no active ingredients had no effects: The conclusion was "”Ultramolecular homeopathy has no observable clinical effects" (the word ultramolecular, in this context, means that the belladonna pills contained no belladonna).

In 2010 he again concluded that homeopathic pills were no more than placebos, as described in Despite the spin, Lewith’s paper surely signals the end of homeopathy (again). [download reprint]

What i cannot understand is that, despite his own findings, his private practice continues to prescribe the Vega machine and continues to prescribe homeopathic pills. And he continues to preach this subject to unfortunate medical students.

Lewith is also one of the practitioners recommended by BSEM. He’s a director of the "College of Medicine". And he’s also an advisor to a charity called Yes To Life. (see A thoroughly dangerous charity: YesToLife promotes nonsense cancer treatments).

3rd year Student Selected Unit

The teaching team includes:

• David Owen – Principal Clinical Teaching Fellow SoM, Holistic Physician
• George Lewith – Professor of Health Research and Consultant Physician
• Caroline Eyles – Homeopathic Physician
• Elaine Cooke – Chiropractic Practitioner
• Phine Dahle – Psychotherapist
• Keith Carr – Reiki Master
• Christine Rose – Homeopath and GP
• David Nicolson – Nutritionalist
• Shelley Baker – Aromatherapist
• Cheryl Dunford – Hypnotherapist
• Dedj Leibbrandt – Herbalist

More details of the teaching team here. There is not a single sceptic among them, so the students don’t get a debate, just propaganda.

In this case. there’s no need for the Freedom of Information Act. The handouts. and the powerpoints are on their web site. They seem to be proud of them

Let’s look at some examples

Chiropractic makes an interesting case, because, in the wake of the Singh-BCA libel case, the claims of chiropractors have been scrutinised as never before and most of their claims have turned out to be bogus. There is a close relationship between Lewith’s unit and the Anglo-European Chiropractic College (the 3rd year module includes a visit there). In fact the handout provided for students, Evidence for Chiropractic Care , was written by the College. It’s interesting because it provides no real evidence whatsoever for the effectiveness of chiropractic care. It’s fairly honest in stating that the view at present is that, for low back pain, it isn’t possible to detect any difference between the usefulness of manipulation by a physiotherapist, by an osteopath or by a chiropractor. Of course it does not draw the obvious conclusion that this makes chiropractic and osteopathy entirely redundant -you can get the same result without all the absurd mumbo jumbo that chiropractors and osteopaths love, or their high-pressure salesmanship and superfluous X-rays. Neither does it mention the sad, but entirely possible, outcome that none of the manipulations are effective for low back pain. There is, for example, no mention of the fascinating paper by Artus et al [download reprint]. This paper concludes

"symptoms seem to improve in a similar pattern in clinical trials following a wide
variety of active as well as inactive treatments."

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

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

This sort of critical thinking is conspicuously absent from this (and all the other) Southampton handouts. The handout is a superb example of bait and switch: No nonsense about infant colic, innate energy or imaginary subluxations appears in it.

Acupuncture is another interesting case because there is quite a lot of research evidence, in stark contrast to the rest of traditional Chinese medicine, for which there is very little research.

 There is a powerpoint show by Susan Woodhead (though it is labelled British Acupuncture Council). The message is simple and totally uncritical. It works.

(1) Real acupuncture and sham acupuncture have been found to be indistinguishable in many trials. This is the case regardless of whether the sham is a retractable needle (or even a toothpick) in the "right" places, or whether it is real needles inserted in the "wrong" places. The latter finding shows clearly that all that stuff about meridians and flow of Qi is sheer hocus pocus. It dates from a pre-scientific age and it was wrong.

(2) A non-blind comparison of acupuncture versus no acupuncture shows an advantage for acupuncture. But the advantage is usually too small to be of any clinical significance. In all probability it is a placebo effect -it’s hard to imagine a more theatrical event than having someone in a white coat stick long needles into you, like a voodoo doll. Sadly, the placebo effect isn’t big enough to be of much use.

Needless to say, none of this is conveyed to the medical students of Southampton. Instead they are shown crude ancient ideas that date from long before anything was known about physiology as though they were actually true. These folks truly live in some alternative universe. Here are some samples from the acupuncture powerpoint show by Susan Woodhead.

Well this is certainly a "different diagnostic language", but no attempt is made to say which one is right. In the mind of the acupuncurist it seems both are true. It is a characteristic of alternative medicine advocates that they have no difficulty in believing simultaneously several mutually contradictory propositions.

As a final exmple of barminess, just look at the acupuncture points (allegedly) on the ear The fact that it is a favoured by some people in the Pentagon as battlefield acupuncture, is more reminiscent of the mad general, Jack D. Ripper, in Dr Strangelove than it is of science.

There is an equally uncritical handout on acupuncture by Val Hopwood. It’s dated March 2003, a time before some of the most valuable experiments were done.

The handout says "sham acupuncture
is generally less effective than true acupuncture", precisely the opposite of what’s known now. And there are some bits that give you a good laugh, always helpful in teaching. I like

“There is little doubt that an intact functioning nervous system is required for acupuncture to produce
analgesia or, for that matter, any physiological changes”

and

Modern techniques: These include hybrid techniques such as electro-acupuncture . . . and Ryadoraku [sic] therapy and Vega testing.

Vega testing!! That’s been disproved dozens of times (not least by George Lewith). And actually the other made-up nonsense is spelled Ryodoraku.

It’s true that there is a short paragraph at the end of the handout headed "Scientific evaluation of acupuncture" but it doesn’t cite a single reference and reads more like excuses for why acupuncture so often fails when it’s tested properly.

Homeopathy. Finally a bit about that most boring of topics, the laughable medicine that contains no medicine, homeopathy. Caroline Eyles is a member for the Society of Homeopaths, the organisation that did nothing when its members were caught out in the murderous practice of recommending homeopathy for prevention of malaria. The Society of Homeopaths also endorses Jeremy Sherr, a man so crazy that he believes he can cure AIDS and malaria with sugar pills.

The homeopathy handout given to the students has 367 references, but somehow manages to omit the references to their own boss’s work showing that the pills are placebos. The handout has all the sciencey-sounding words, abused by people who don’t understand them.

"The remedy will be particularly effective if matched to the specific/particular characteristics of the individual (the ‘totality’ of the patient) on all levels, including the emotional and mental levels, as well as just the physical symptoms. ‘Resonance’ with the remedy’s curative power will then be at it’s [sic] best."

The handout is totally misleading about the current state of research. It says

"increasing clinical research confirms it’s [sic] clinical effectiveness in treating patients, including babies and animals (where a placebo effect would be hard to justify)."

 The powerpont show by Caroline Eyles shows all the insight of a mediaeval vitalist

Anyone who has to rely on the utterly discredited Jacques Benveniste as evidence is clearly clutching at straws. What’s more interesting about this slide the admission that "reproducibility is a problem -oops, an issue" and that RCTs (done largely by homeopaths of course) have "various methodological flaws and poor external validity". You’d think that if that was the best that could be produced after 200 yours, they’d shut up shop and get another job. But, like aging vicars who long since stopped believing in god, but are damned if they’ll give up the nice country rectory, they struggle on, sounding increasingly desperate.

### How have topics like this become so embedded in a medical course at a Russell group university?

The details above are a bit tedious and repetitive. It’s already established that hardly any alternative medicine works. Don’t take my word for it. Check the web site of the US National Center for Complementary and Alternative Medicine (NCCAM) who, at a cost of over \$2 billion have produced nothing useful.

A rather more interesting question is how a good university like Southampton comes to be exposing its medical students to teaching like this. There must be some powerful allies higher up in the university. In this case it’s pretty obvious who thay are.

Professor Stephen Holgate MD DSc CSc FRCP FRCPath FIBiol FBMS FMed Sci CBE has to be the primary suspect, He’s listed as one of Southampton’s Outstanding Academics. His work is nothing to do with alternative medicine but he’s been a long term supporter of the late unlamented Prince of Wales’ Foundation, and he’s now on the advisory board of it’s successor, the so called "College of Medicine" (for more information about that place see the new “College of Medicine” arising from the ashes of the Prince’s Foundation for Integrated Health, and also Don’t be deceived. The new “College of Medicine” is a fraud and delusion ). His description on that site reads thus.

"Stephen Holgate is MRC Clinical Professor of Immunopharmacology at the University of Southampton School of Medicine and Honorary Consultant Physician at Southampton University Hospital Trust. He is also chair of the MRC’s Populations and Systems Medicine Board. Specialising in respiratory medicine, he is the author of over 800 peer-reviewed papers and contributions to scientific journals and editor of major textbooks on asthma and rhinitis. He is Co-Editor of Clinical and Experimental Allergy, Associate Editor of Clinical Science and on the editorial board of 25 other scientific journals."

Clearly a busy man. Personally I’m deeply suspicious of anyone who claims to be the author of over 800 papers. He graduated in medicine in 1971, so that is an average of over 20 papers a year since then, one every two or three weeks. I’d have trouble reading that many, never mind writing them.

Holgate’s long-standing interest in alternative medicine is baffling. He’s published on the topic with George Lewith, who, incidentally, is one of the directors of the "College of Medicine"..

It may be unkind to mention that, for many years now, I’ve been hearing rumours that Holgate is suffering from an unusually bad case of Knight starvation.

The Division of Medical Education appears to be the other big source of support for. anti-scientific medicine. That is very odd, I know, but it was also the medical education people who were responsible for mis-educating medical students at. St. Bartholomew’s and at Edinburgh university. Southampton’s Division of Medical Education has a mind-boggling 60 academic and support staff. Two of them are of particular interest here.

Faith Hill is director of the division. Her profile doesn’t say anything about alternative medicine, but her interest is clear from a 2003 paper, Complementary and alternative medicine: the next generation of health promotion?. The research consisted of reporting anecdotes from interviews of 52 unnamed people (this sort of thing seems to pass for research in the social sciences). It starts badly by misrepresenting the conclusions of the House of Lords report (2000) on CAM. Although it comes to no useful conclusions, it certainly shows a high tolerance of nonsensical treatments.

Chris Stephens is  Associate Dean of Medical Education & Student Experience. His sympathy is shown by a paper he wrote In 2001, with David Owen (the homeopath, above) and George Lewith: Can doctors respond to patients’ increasing interest in complementary and alternative medicine?. Two of the conclusions of this paper were as follows.

"Doctors are training in complementary and alternative medicine and report benefits both for their patients and themselves"

Well, no actually. It wasn’t true then, and it’s probably even less true now. There’s now a lot more evidence and most of it shows alternative medicine doesn’t work.

"Doctors need to address training in and practice of complementary and alternative medicine within their own organisations"

Yes they certainly need to do that.

And the first thing that Drs Hill and Stephens should do is look a bit more closely about what’s taught in their own university, I hope that this post helps them,

### Follow-up

4 July 2011. A correspondent has just pointed out that Chris Stephens is a member of the General Chiropractic Council. The GCC is a truly pathetic pseudo-regulator. In the wake of the Simon Singh affair it has been kept busy fending off well-justified complaints against untrue claims made by chiropractors. The GCC is a sad joke, but it’s even sadder to see a Dean of Medical Education at the University of Southampton being involved with an organisation that has treated little matters of truth with such disdain.

A rather unkind tweet from (ex)-chiropractor @RichardLanigan.

“Chris is just another light weight academic who likes being on committees. Regulatory bodies are full of them”