Corrected and searchable version of Google books edition

Download review of Lectures on Biostatistics (THES, 1973).

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‘We know little about the effect of diet on health. That’s why so much is written about it’. That is the title of a post in which I advocate the view put by John Ioannidis that remarkably little is known about the health effects if individual nutrients. That ignorance has given rise to a vast industry selling advice that has little evidence to support it.

The 2016 Conference of the so-called "College of Medicine" had the title "Food, the Forgotten Medicine". This post gives some background information about some of the speakers at this event. I’m sorry it appears to be too ad hominem, but the only way to judge the meeting is via the track record of the speakers.

Quite a lot has been written here about the "College of Medicine". It is the direct successor of the Prince of Wales’ late, unlamented, Foundation for Integrated Health. But unlike the latter, its name is disguises its promotion of quackery. Originally it was going to be called the “College of Integrated Health”, but that wasn’t sufficently deceptive so the name was dropped.

For the history of the organisation, see

The new “College of Medicine” arising from the ashes of the Prince’s Foundation for Integrated Health

Don’t be deceived. The new “College of Medicine” is a fraud and delusion

The College of Medicine is in the pocket of Crapita Capita. Is Graeme Catto selling out?

The conference programme (download pdf) is a masterpiece of bait and switch. It is a mixture of very respectable people, and outright quacks. The former are invited to give legitimacy to the latter. The names may not be familiar to those who don’t follow the antics of the magic medicine community, so here is a bit of information about some of them.

The introduction to the meeting was by Michael Dixon and Catherine Zollman, both veterans of the Prince of Wales Foundation, and both devoted enthusiasts for magic medicne. Zollman even believes in the battiest of all forms of magic medicine, homeopathy (download pdf), for which she totally misrepresents the evidence. Zollman works now at the Penny Brohn centre in Bristol. She’s also linked to the "Portland Centre for integrative medicine" which is run by Elizabeth Thompson, another advocate of homeopathy. It came into being after NHS Bristol shut down the Bristol Homeopathic Hospital, on the very good grounds that it doesn’t work.

Now, like most magic medicine it is privatised. The Penny Brohn shop will sell you a wide range of expensive and useless "supplements". For example, Biocare Antioxidant capsules at £37 for 90. Biocare make several unjustified claims for their benefits. Among other unnecessary ingredients, they contain a very small amount of green tea. That’s a favourite of "health food addicts", and it was the subject of a recent paper that contains one of the daftest statistical solecisms I’ve ever encountered

"To protect against type II errors, no corrections were applied for multiple comparisons".

If you don’t understand that, try this paper.
The results are almost certainly false positives, despite the fact that it appeared in Lancet Neurology. It’s yet another example of broken peer review.

It’s been know for decades now that “antioxidant” is no more than a marketing term, There is no evidence of benefit and large doses can be harmful. This obviously doesn’t worry the College of Medicine.

Margaret Rayman was the next speaker. She’s a real nutritionist. Mixing the real with the crackpots is a standard bait and switch tactic.

Eleni Tsiompanou, came next. She runs yet another private "wellness" clinic, which makes all the usual exaggerated claims. She seems to have an obsession with Hippocrates (hint: medicine has moved on since then). Dr Eleni’s Joy Biscuits may or may not taste good, but their health-giving properties are make-believe.

Andrew Weil, from the University of Arizona
gave the keynote address. He’s described as "one of the world’s leading authorities on Nutrition and Health". That description alone is sufficient to show the fantasy land in which the College of Medicine exists. He’s a typical supplement salesman, presumably very rich. There is no excuse for not knowing about him. It was 1988 when Arnold Relman (who was editor of the New England Journal of Medicine) wrote A Trip to Stonesville: Some Notes on Andrew Weil, M.D..

“Like so many of the other gurus of alternative medicine, Weil is not bothered by logical contradictions in his argument, or encumbered by a need to search for objective evidence.”

This blog has mentioned his more recent activities, many times.

Alex Richardson, of Oxford Food and Behaviour Research (a charity, not part of the university) is an enthusiast for omega-3, a favourite of the supplement industry, She has published several papers that show little evidence of effectiveness. That looks entirely honest. On the other hand, their News section contains many links to the notorious supplement industry lobby site, Nutraingredients, one of the least reliable sources of information on the web (I get their newsletter, a constant source of hilarity and raised eyebrows). I find this worrying for someone who claims to be evidence-based. I’m told that her charity is funded largely by the supplement industry (though I can’t find any mention of that on the web site).

Stephen Devries was a new name to me. You can infer what he’s like from the fact that he has been endorsed byt Andrew Weil, and that his address is "Institute for Integrative Cardiology" ("Integrative" is the latest euphemism for quackery). Never trust any talk with a title that contains "The truth about". His was called "The scientific truth about fats and sugars," In a video, he claims that diet has been shown to reduce heart disease by 70%. which gives you a good idea of his ability to assess evidence. But the claim doubtless helps to sell his books.

Prof Tim Spector, of Kings College London, was next. As far as I know he’s a perfectly respectable scientist, albeit one with books to sell, But his talk is now online, and it was a bit like a born-again microbiome enthusiast. He seemed to be too impressed by the PREDIMED study, despite it’s statistical unsoundness, which was pointed out by Ioannidis. Little evidence was presented, though at least he was more sensible than the audience about the uselessness of multivitamin tablets.

Simon Mills talked on “Herbs and spices. Using Mother Nature’s pharmacy to maintain health and cure illness”. He’s a herbalist who has featured here many times. I can recommend especially his video about Hot and Cold herbs as a superb example of fantasy science.

Annie Anderson, is Professor of Public Health Nutrition and
Founder of the Scottish Cancer Prevention Network. She’s a respectable nutritionist and public health person, albeit with their customary disregard of problems of causality.

Patrick Holden is chair of the Sustainable Food Trust. He promotes "organic farming". Much though I dislike the cruelty of factory farms, the "organic" industry is largely a way of making food more expensive with no health benefits.

The Michael Pittilo 2016 Student Essay Prize was awarded after lunch. Pittilo has featured frequently on this blog as a result of his execrable promotion of quackery -see, in particular, A very bad report: gamma minus for the vice-chancellor.

Nutritional advice for patients with cancer. This discussion involved three people.
Professor Robert Thomas, Consultant Oncologist, Addenbrookes and Bedford Hospitals, Dr Clare Shaw, Consultant Dietitian, Royal Marsden Hospital and Dr Catherine Zollman, GP and Clinical Lead, Penny Brohn UK.

Robert Thomas came to my attention when I noticed that he, as a regular cancer consultant had spoken at a meeting of the quack charity, “YestoLife”. When I saw he was scheduled tp speak at another quack conference. After I’d written to him to point out the track records of some of the people at the meeting, he withdrew from one of them. See The exploitation of cancer patients is wicked. Carrot juice for lunch, then die destitute. The influence seems to have been temporary though. He continues to lend respectability to many dodgy meetings. He edits the Cancernet web site. This site lends credence to bizarre treatments like homeopathy and crystal healing. It used to sell hair mineral analysis, a well-known phony diagnostic method the main purpose of which is to sell you expensive “supplements”. They still sell the “Cancer Risk Nutritional Profile”. for £295.00, despite the fact that it provides no proven benefits.

Robert Thomas designed a food "supplement", Pomi-T: capsules that contain Pomegranate, Green tea, Broccoli and Curcumin. Oddly, he seems still to subscribe to the antioxidant myth. Even the supplement industry admits that that’s a lost cause, but that doesn’t stop its use in marketing. The one randomised trial of these pills for prostate cancer was inconclusive. Prostate Cancer UK says "We would not encourage any man with prostate cancer to start taking Pomi-T food supplements on the basis of this research". Nevertheless it’s promoted on Cancernet.co.uk and widely sold. The Pomi-T site boasts about the (inconclusive) trial, but says "Pomi-T® is not a medicinal product".

There was a cookery demonstration by Dale Pinnock "The medicinal chef" The programme does not tell us whether he made is signature dish "the Famous Flu Fighting Soup". Needless to say, there isn’t the slightest reason to believe that his soup has the slightest effect on flu.

In summary, the whole meeting was devoted to exaggerating vastly the effect of particular foods. It also acted as advertising for people with something to sell. Much of it was outright quackery, with a leavening of more respectable people, a standard part of the bait-and-switch methods used by all quacks in their attempts to make themselves sound respectable. I find it impossible to tell how much the participants actually believe what they say, and how much it’s a simple commercial drive.

The thing that really worries me is why someone like Phil Hammond supports this sort of thing by chairing their meetings (as he did for the "College of Medicine’s" direct predecessor, the Prince’s Foundation for Integrated Health. His defence of the NHS has made him something of a hero to me. He assured me that he’d asked people to stick to evidence. In that he clearly failed. I guess they must pay well.

### Follow-up

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

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

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

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

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

### A letter to the university from a student

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

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

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

### David Peters: wishful thinking?

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

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

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

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

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

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

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

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

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

### The BSc (Hons) degree in naturopathy

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

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

Uses of herbal teas in naturopathic dietary care

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

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

What Westminster says

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

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

What Westminster says

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

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

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

Allergy and Intolerance 3CMwS03 18/02

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

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

Naturopathic Detoxification 23 CMES03 25/02 Detox Myth of Fact

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

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

The practice of healing (3CMSS01 2/12)

Next we retreat still further into fantasy land

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

Is that definition quite clear?

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

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

Environmental stress

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

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

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

But don’t despair. Help is at hand.

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

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

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

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

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

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

### Follow-up

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

.

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

There is no topic more widely discussed than what one should eat in order to stay healthy. And there are few topics where there evidence is so lacking in quality. This post isn’t about quackery, but about something much more important. it is about the real science (if it merits that description) behind dietary advice.  I’m not an expert in nutrition, but I do know a bit about the nature of evidence. I’m continually astonished by the weakness of the evidence for some things that have become received truths, and nowhere is that more true than in nutrition.

 The BMJ used my review of Gary Taube’s book, The Diet Delusion, to start off their new Round Table feature [full text link to BMJ]. The published version had some big cuts so I publish the original version here.  Taubes was kind enough to send me a copy of the book after I’d mentioned his wonderful New York Times piece in my previous excursion into the murky world of diet and health, Diet and health. What can you believe: or does bacon kill you?

The biggest omission in the BMJ version was Taubes’ own ten point summary of his conclusions (on page 454).

"“As I emerge from this research, though, certain conclusions seem inescapable to me, based on existing knowledge

1. Dietary fat, whether saturated or not, is not a cause of obesity, heart disease, or any other chronic disease of civilization
2. The problem is the carbohydrates in the diet, their effect on insulin secretion, and thus the hormonal regulation of homeostasis – the entire harmonic ensemble of the human body.  The more easily digestible and refined the carbohydrates, the greater the effect on our health, weight, and well-being.
3. Sugars – sucrose and high-fructose corn syrup specifically – are particularly harmful, probably because the combination of fructose and glucose simultaneously elevates insulin levels while overloading the liver with carbohydrates.
4. Through their direct effect on insulin and blood sugar, refined carbohydrates, starches, and sugars are the dietary cause of coronary heart disease and diabetes.  They are the most likely dietary causes of cancer, Alzheimer’s disease, and the other chronic diseases of civilization.
5. Obesity is a disorder of excess fat accumulation, not overeating, and not sedentary behaviour.
6. Consuming excess calories does not cause us to grow fatter, any more than it causes a child to grow taller.  Expending more energy than we consume does not lead to long-term weight loss; it leads to hunger.
7. Fattening and obesity are caused by an imbalance – a disequilibrium – in the hormonal regulation of adipose tissue and fat metabolism.  Fat synthesis and storage exceed the mobilization of fat from the adipose tissue and its subsequent oxidation.  We become leaner when the hormonal regulation of the fat tissue reverses this balance.
8. Insulin is the primary regulator of fat storage.  When insulin levels are elevated – either chronically or after a meal – we accumulate fat in our fat tissue.  When insulin levels fall, we release fat from our fat tissue and use it for fuel.
9. By stimulating insulin secretion, carbohydrates make us fat and ultimately cause obesity.  The fewer carbohydrates we consume, the leaner we will be.
10. By driving fat accumulation, carbohydrates also increase hunger and decrease the amount of energy we expend in metabolism and physical activity.”

It is on these bases that Taubes suggests that the increase in obesity is, in part, a consequence of the recommendation of a  low fat, and hence high sugar diet.

If length had allowed, there should certainly have been a reference here to Robert Lustig of UCSF. He is an academic nutritionist who supports the main thesis of Taubes’ book. See, for example, his 2005 review, Childhood obesity: behavioral aberration or biochemical drive? Reinterpreting the First Law of Thermodynamics [full
]. Lustig’s slide show, The Trouble with Fructose is available in the NIH web site.

There are a couple of other articles by Taubes that are well worth reading. The Scientist and the Stairmaster Why most of us believe that exercise makes us thinner—and why we’re wrong. Gary Taubes, in New York Magazine, and We can’t work it out, in the Guardian.

You can see Taubes in action on YouTube, for example in “on Cholesterol and Science Practices“, and “on Carbohydrates and Degenerative Diseases“. There is also a video of Taubes on medical grand rounds at Dartmouth-Hitchcock Medical Center in June 2009. You can see Robert Lustig on YouTube too: “Sugar: The Bitter Truth“.

### Follow-up

22 December.2009,  Unlike the serious questions dealt with in the Diet Delusion, this concerns merely another bit of the ubiquitous nutribollocks that crops up in the media,  While writing this I was listening to the excellent early evening news programme, PM, run by Eddie Mair, when a diet-related topic came up,  it was nonsense about how a cocktail made with vodka, cointreau, acai juice and pomegranate juice would not give you a hangover.  I suppose it was meant as christmas fun but  whenever I hear the words ‘antioxidant‘ or ‘superfood; I feel an email coming on.  It seems that Eddie Mair liked the fact that the email contained the words ‘quack’ and ‘codswallop’  because the next thing I knew I was asked to give an interview on next day’s programme.  The mp3 is here.

We have listed many reasons hear why you should never trust Boots.  Here are the previous ones.

This post is about a "functional food".  That is about something a bit more serious than homeopathy, though I’ll return to that standing joke in the follow-up, because of Boots’ latest shocking admission..

Alternative medicine advocates love to blame Big Pharma for every criticism of magic medicine.  In contrast, people like me, Ben Goldacre and a host of others have often pointed out that the differences seem to get ever smaller between the huge Alternative industry (about $60 billion per year), and the even huger regular pharmaceutical industry (around$600 billion per year),

Boots are as good an example as any.  While representing themselves as ethical pharmacists, they seem to have no compunction at all in highly deceptive advertising of medicines and supplements which are utterly useless rip-offs.

The easiest way to make money is to sell something that is alleged to cure a common, but ill-defined problem, that has a lot of spontaneous variability.. Like stress, for example.

The Times carried a piece Is Boots’s new Lactium pill the solution to stress?. Needless to say the question wasn’t answered.  It was more like an infomercial than serious journalism.  Here is what Boots say.

 What does it do? This product contains Lactium, a unique ingredient which is proven to help with the stresses of every day life, helping you through a stressful day. Also contains B vitamins, magnesium and vitamin C, which help to support a healthy immune system and energy levels. Why is it different? This one a day supplement contains the patented ingredient Lactium. All Boots vitamins and suppliers are checked to ensure they meet our high quality and safety standards.

So what is this "unique ingredient", Lactium?  It is a produced by digestion of cow’s milk with trypsin. It was patented in 1995 by the French company, Ingredia, It is now distributed in the USA and Canada by Pharmachem. which describes itself as “a leader in the nutraceutical industry.”  Drink a glass of milk and your digestive system will make it for you.  Free.  Boots charge you £4.99 for only seven capsules.

### What’s the evidence?

The search doesn’t start well. A search of the medical literature with Pubmed for "lactium" produces no results at all. Search for "casein hydrolysate" gives quite a lot, but "casein hydrolysate AND stress" gives only seven, of which only one looks at effects in man, Messaoudi M, Lefranc-Millot C, Desor D, Demagny B, Bourdon L. Eur J Nutr. 2005.

There is a list of nineteen "studies" on the Pharmachem web site That is where Boots sent me when I asked about evidence, so let’s take a look.

Of the nineteen studies, most are just advertising slide shows or unpublished stuff. Two appear to be duplicated. There are only two proper published papers worth looking at, and one of these is in
rats not man.  The human paper first.

Paper 1  Effects of a Bovine Alpha S1-Casein Tryptic Hydrolysate (CTH) on Sleep Disorder in Japanese General Population, Zara de Saint-Hilaire, Michaël Messaoudi, Didier Desor and Toshinori Kobayashi [reprint here]   The authors come from France, Switzerland and Japan.

This paper was published in The Open Sleep Journal, 2009, 2, 26-32, one of 200 or so open access journals published by Bentham Science Publishers.

It has to be one of the worst clinical trials that I’ve encountered.  It was conducted on 32 subjects, healthy Japanese men and women aged 25-40 and had reported sleeping disorders.  It was double blind and placebo controlled, so apart from the fact that only 12 of the 32 subjects were in the control group, what went wrong?

The results were assessed as subjective sleep quality using the Japanese Pittsburg Sleep Quality Index (PSQI-J).  This gave a total .score and seven component scores: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.

In the results section we read, for total PSQI score

"As shown in Table 2, the Mann-Whitney U-test did not show significant differences between CTH [casein tryptic hydrolysate] and Placebo groups in PSQI-J total scores at D0 (U=85; NS), D14 (U=86.5; NS), D28 (U=98.5; NS) and D35 (U=99.5; NS)."

Then we read exactly similar statements for the seven component scores.  For example,. for Sleep Quality

As shown in Table 3, the Mann-Whitney U-test did not show significant differences between the sleep quality scores of CTH and Placebo groups at D0 (U=110.5; NS), D14 (U=108.5; NS), D28 (U=110; NS) and D35 (U=108.5; NS).

The discussion states

"The comparisons between the two groups with the test of Mann-Whitney did not show significant differences, probably because of the control product’s placebo effect. Despite everything, the paired comparisons with the test of Wilcoxon show interesting effects of CTH on sleep disorders of the treated subjects. "

Aha, so those pesky controls are to blame! But despite this negative result the abstract of the paper says

"CTH significantly improves the PSQI total score of the treated subjects. It particularly improves the sleep quality after two weeks of treatment, decreases the sleep latency and the daytime dysfunction after four weeks of treatment.

Given the antistress properties of CTH, it seems possible to relate the detected improvement of sleep aspects to a reduction of stress following its’ chronic administration."

So there seems to be a direct contradiction between the actual results and the announced outcome of the trial. How could this happen?  The way that the results are presented make it hard to
tell.  As far as I can tell, the answer is that, having failed to find evidence of real differences between CTH and placebo, the authors gave up on the placebo control and looked simply at the change
from the day 0 basleine values within the CTH group and, separately, within the placebo group.  Some of these differences did pass statistical significance but if you analyse it
that way. there is no point in having a control group at all.

How on earth did such a poor paper get published in a peer-reviewed journal?  One answer is that there are now so many peer-reviewed journals, that just about any paper, however poor, can get published
in some journal that describes itself as ‘peer-reviewed’.  At the lower end of the status hierarchy, the system is simply broken.

Bentham Science Publishers are the publishers of the The Open Sleep Journal. (pity they saw fit to hijack the name of UCL’s spiritual founder, Jeremy Bentham). They publish 92 online and print journals, 200 plus open access journals, and related print/online book series. This publsher has a less than perfect reputation.  There can be no scientist of any age or reputation who hasn’t had dozens of emails begging them to become editors of one or other of their journals or to write something for them. They have been described as a "pyramid scheme” for open access.  It seems that every Tom, Dick and Harry has been asked.  They have been described under the heading Black sheep among Open Access Journals and Publishers.  More background can be found at Open Access News..

Most telling of all, a spoof paper was sent to a Bentham journal, The Open Information Science Journal.  . There is a good account of the episode the New Scientist, under the title “CRAP paper accepted by journal”.  It was the initiative if a graduate student at Cornell University. After getting emails from Bentham, he said “”It really painted a picture of vanity publishing”. The spoof paper was computer-generated rubbish, but it was accepted anyway, without comment.  Not only did it appear that is was never reviewed but the editors even failed to notice that the authors said the paper came from the "Center for Research in Applied Phrenology", or CRAP.  .The publication fee was \$800, to be sent to a PO Box in the United Arab Emirates. Having made the point, the authors withdrew the paper.

Paper 5 in the list of nineteen stidies is also worth a look.  It’s about rats not humans but it is in a respectable journal The FASEB Journal Express Article doi:10.1096/fj.00-0685fje (Published online June 8, 2001) [reprint here].
Characterization of α-casozepine, a tryptic peptide from bovine αs1-casein with benzodiazepine-like activity. Laurent Miclo et al.

This paper provides the basis for the claim that digested milk has an action like the benzodiazepine class of drugs, which includes diazepam (Valium).  The milk hydrolysate, lactium was tested in rats and found to have some activity in tests that are alleged to measure effects on anxiety (I haven’t looked closely at the data, since the claims relate to humans)..  The milk protein, bovine αS1 casein contains 214 amino acids.  One of the many products of its digestion is a 10-amino-acid fragment (residues 91 -100) known as α-casozepine and this is the only product that was found to have an affinity for the γ-amino-butyric acid (GABA) type A receptors, which is where benzodiazepines are thought to act.  There are a few snags with this idea.

• The affinity of α-casozepine peptide had 10,000-fold lower affinity for the benzodiazepine site of the GABAA than did diazepam, whereas allegedly the peptide was 10-fold more potent than diazepam in one of the rat tests.
• The is no statement anywhere of how much of the α-casozepine peptide is present in the stuff sold my Boots, or whether it can be absorbed
• And if digested milk did act like diazepam, it should clearly be callled a drug not a food.

### What’s the conclusion about lactium?

Here is what I make of it.

Does it relieve stress?  The evidence that it works any better than drinking a glass of milk is negligible. Tha advertising is grossly misleading and the price is extortionate.

Corruption of science.  There is a more interesting aspect than that though.  The case of lactium isn’t quite like the regular sort of alternative medicine scam.  It isn’t inherently absurd, like homeopathy.  The science isn’t the sort of ridiculous pseudo-scientific ramblings of magic medicine advocates who pretend it is all quantum theory The papers cited here are real papers, using real instruments and published in real journals,

What is interesting about that is that they show very clearly the corruption of real science that occurs at its fringes,  This is science in the service of the dairy industry and in the service of the vast supplements industry.  These are people who want to sell you a supplement for everything.

Medical claims are made for supplements, yet loopholes in the law are exploited to maintain that they are foods not drugs.  The law and the companies that exploit it are deeply dishonest.  That’s bad enough. but the real tragedy is when science itself is corrupted in the service of sales.

Big Pharma and the alternative industry. Nowhere is the slose alliance between Big Pharma and the alternative medicine industry more obvious than in the supplement and nutriceutical markets. Often the same companies run both. Their aim is to sell you thinks that you don’t need, for conditions that you may well not have, and to lighten your wallet in the process. Don’t believe for a moment that the dark-suited executives give a bugger about your health. You are a market to be exploited.

If you doubt that, look from time to time at one of the nutraceutical industry web sites, like nutraingredients.com. They even have a bit to say about lactium.  They are particularly amusing at the moment because the European Food Safety Authority (EFSA) has had the temerity to demand that when health claims are made for foods, there is actually some small element of truth in the claims.  The level of righteous indignation caused in the young food industry executives at the thought that they might have to tell the truth is everywhere to see. For example, try Life in a European health claims wasteland.  Or, more relevant to Lactium, Opportunity remains in dairy bioactives despite departures. Here’s
a quotation from that one.

“Tage Affertsholt, managing partner at 3A Business Consulting, told NutraIngredients.com that the feedback from industry is that the very restrictive approach to health claims adopted by the European Food Safety Authority (EFSA) will hamper growth potential.”

“Affertsholt said: “Some companies are giving up and leaving the game to concentrate on more traditional dairy ingredients.”

### Science and government policy

It may not have escaped your notice that the sort of low grade, corrupted, fringe science described here, is precisely the sort that is being encouraged by government policies. You are expected to get lots of publications, so never mind the details, just churn ’em out;  The hundreds of new journals that have been created will allow you to get as meny peer-reviwed publications as you want without too much fuss, and you can very easily put an editorship of one of them on your CV when you fill in that bit about indicators of esteem.  The box tickers in HR will never know that it’s a mickey mouse journal.

### Follow-up

Boots own up to selling crap

Although this post was nothing to do with joke subjects like homeopathy, it isn’t possible to write about Boots without mentioning the performance of their  professional standards director, Paul Bennett, when he appeared before the Parliamentary Select Committee for Science and Technology..  This committee was holding an “evidence check” session on homeopathy (it’s nothing short of surreal that this should be happening in 2009, uh?).  The video can be seen here, and an uncorrected transcript.   It is quite fun in places.  You can also read the written evidence that was submitted.

Even the Daily Mail didn’t misss this one. Fioana Macrae wrote Boots boss admits they sell homeopathic remedies ‘because they’re popular, not because they work’

“It could go down as a Boot in Mouth moment.

Yesterday, the company that boasts shelf upon shelf of arnica, St John’s wort, flower remedies and calendula cream admitted that homeopathy doesn’t necessarily work.

But it does sell. Which according to Paul Bennett, the man from Boots, is why the pharmacy chain stocks such products in the first place.

Mr Bennett, professional standards director for Boots, told a committee of MPs that there was no medical evidence that homeopathic pills and potions work.

‘There is certainly a consumer demand for these products,’ he said. ‘I have no evidence to suggest they are efficacious.

‘It is about consumer choice for us and a large number of our customers believe they are efficacious.’

His declaration recalls Gerald Ratner’s infamous admission in 1991 that one of the gifts sold by his chain of jewellers was ‘total crap’.”

The Times noticed too, with Boots ‘labels homeopathy as effective despite lack of evidence‘.

Now you know that you can’t trust Boots. You heard it from the mouth of their professional standards director.

A commentary on the meeting by a clinical scientist summed up Bennett’s contribution thus

"Paul Bennett from Boots had to admit that there was no evidence, but regaled the committee with the mealy-mouthed flannel about customer choice that we have come to expect from his amoral employer."

Well said

The third session of the Scitech evidence check can be seen here, and the uncorrected transcript is here.  It is, in a grim way, pure comedy gold, More of that later.