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The "supplement" industry is a scam that dwarfs all other forms of alternative medicine. Sales are worth over $100 billion a year, a staggering sum. But the claims they make are largely untrue: plain fraudulent. Although the industry’s advertisements like to claim "naturalness". in fact most of the synthetic vitamins are manufactured by big pharma companies. The pharmaceutical industry has not been slow to cash in on an industry in which unverified claims can be made with impunity.

When I saw advertised Hotshot, "a proprietary formulation of organic ingredients" that is alleged to cure or prevent muscle cramps, I would have assumed that it was just another scam. Then I saw that the people behind it were very highly-regarded scientists, Rod MacKinnon and Bruce Bean, both of whom I have met.

The Hotshot’s website gives this background.

"For Dr. Rod MacKinnon, a Nobel Prize-winning neuroscientist/endurance athlete, the invention of HOTSHOT was personal.

After surviving life threatening muscle cramps while deep sea kayaking off the coast of Cape Cod, he discovered that existing cramp remedies – that target the muscle – didn’t work. Calling upon his Nobel Prize-winning expertise on ion channels, Rod reasoned that preventing and treating cramps began with focusing on the nerve, not the muscle.

Five years of scientific research later, Rod has perfected HOTSHOT, the kick-ass, proprietary formulation of organic ingredients, powerful enough to stop muscle cramps where they start. At the nerve.

Today, Rod’s genius solution has created a new category in sports nutrition: Neuro Muscular Performance (NMP). It’s how an athlete’s nerves and muscles work together in an optimal way. HOTSHOT boosts your NMP to stop muscle cramps. So you can push harder, train longer and finish stronger."  

For a start, it’s pretty obvious that MacKinnon has not spent the last five years developing a cure for cramp. His publications don’t even mention the topic. Neither do Bruce Bean’s.

I’d like to thank Bruce Bean for answering some questions I put to him. He said it’s "designed to be as strong as possible in activating TRPV1 and TRPA1 channels". After some hunting I found that it contains

Filtered Water, Organic Cane Sugar, Organic Gum Arabic, Organic Lime Juice Concentrate, Pectin, Sea Salt, Natural Flavor, Organic Stevia Extract, Organic Cinnamon, Organic Ginger, Organic Capsaicin

The first ingredient is sugar: "the 1.7oz shot contains enough sugar to make a can of Coke blush with 5.9 grams per ounce vs. 3.3 per ounce of Coke".[ref].

The TRP (transient receptor potential) receptors form a family of 28 related ion channels,Their physiology is far from being well understood, but they are thought to be important for mediating taste and pain, The TRPV1 channel is also known as the receptor for capsaicin (found in chilli peppers). The TRPA1 responds to the active principle in Wasabi.

I’m quite happy to believe that most cramp is caused by unsychronised activity of motor nerves causing muscle fibres to contract in an uncordinated way (though it isn’t really known that this is the usual mechanism, or what triggers it in the first place), The problem is that there is no good reason at all to think that stimulating TRP receptors in the gastro-intestinal tract will stop, within a minute or so, the activity of motor nerves in the spinal cord.

But, as always, there is no point in discussing mechanisms until we are sure that there is a phenomenon to be explained. What is the actual evidence that Hotshot either prevents of cures cramps, as claimed? The Hotshot’s web site has pages about Our Science, Its title is The Truth about Muscle Cramps. That’s not a good start because it’s well known that nobody understands cramp.

So follow the link to See our Scientific Studies. It has three references, two are to unpublished work. The third is not about Hotshot, but about pickle juice. This was also the only reference sent to me by Bruce Bean. Its title is ‘Reflex Inhibition of Electrically Induced
Muscle Cramps in Hypohydrated Humans’, Miller et al,, 2010 [Download pdf]. Since it’s the only published work, it’s worth looking at in detail.

Miller et al., is not about exercise-induced cramp, but about a cramp-like condition that can be induced by electrical stimulation of a muscle in the sole of the foot (flexor hallucis brevis). The intention of the paper was to investigate anecdotal reports that pickle juice and prevent or stop cramps. It was a small study (only 10 subjects). After getting the subjects dehydrated, they cramp was induced electrically, and two seconds after it started, they drank either pickle juice or distilled water. They weren’t asked about pain: the extent of cramp was judged by electromyograph records. At least a week later, the test was repeated with the other drink (the order in which they were given was randomised). So it was a crossover design.

There was no detectable difference between water and pickle juice on the intensity of the cramp. But the duration of the cramp was said to be shorter. The mean duration after water was 133.7 ± 15.9 s and the mean duration after pickle juice was 84.6 ± 18.5 s. A t test gives P = 0.075. However each subject had both treatments and the mean reduction in duration was 49.1 ± 14.6 s and a paired t test gives P = 0.008. This is close to the 3-standard-deviation difference which I recommended as a minimal criterion, so what could possibly go wrong?.

The result certainly suggests that pickle juice might reduce the duration of cramps, but it’s far from conclusive, for the following reasons. First, it must have been very obvious indeed to the subjects whether they were drinking water or pickle juice. Secondly, paired t tests are not the right way to analyse crossover experiments, as explained here, Unfortunately the 10 differences are not given so there is no way to judge the consistency of the responses. Thirdly, two outcomes were measured (intensity and duration), and no correction was made for multiple comparisons. Finally, P = 0.008 is convincing evidence only if you assume that there’s a roughly 50:50 chance of the pickle-juice folk-lore being right before the experiment was started. For most folk remedies, that would be a pretty implausible assumption. The vast majority of folk remedies turn out to be useless when tested properly.

Nevertheless, the results are sufficiently suggestive that it might be worth testing Hotshot properly. One might have expected that would have been done before marketing started, It wasn’t.

Bruce Bean tells me that they tried it on friends who said that it worked. Perhaps that’s not so surprising: there can be no condition more susceptible than muscle cramps to self-deception because of regression to the mean

They found a business partner, Flex Pharma, and Mackinnon set up a company. Let’s see how they are doing.

Flex Pharma

The hyperbole in the advertisements for Hotshots is entirely legal in the USA. The infamous 1994 “Dietary Supplement Health and Education Act (DSHEA)” allows almost any claim to be made for herbs etc as long as they are described as a "dietary supplement". All they have to do is add in the small print:

"These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease".

Of course medical claims are made: it’s sold to prevent and treat muscle cramp (and I can’t even find the weasel words on the web site).

As well as Hotshot, Flex Pharma are also testing a drug, FLX-787, a TRP receptor agonist of undisclosed structure.  It is hoping get FDA approval for treatment of nocturnal leg cramps (NLCs) and treatment of spasticity in multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS) patients. It would be great if it works, but we still don’t know whether it does,

The financial press doesn’t seem to be very optimistic. When Flex Pharma was launched on the stock market at the beginning of 2015, its initial public offering, raised $$86.4 million, at $16 per share. The biotech boom of the previous few years was still strong. In 2016, the outlook seems less rosy. The investment advice site Seeking Alpha had a scathing evaluation in June 2016. Its title was "Flex Pharma: What A Load Of Cramp". It has some remarkably astute assessments of the pharmacology, as well as of financial risks. The summary reads thus:

  • We estimate FLKS will burn at least 40 million of its $84 million in cash this year on clinical trials for FLX-787 and marketing spend for its new cramp supplement called “HOTSHOT.”
  • Based on its high cash burn, we expect a large, dilutive equity raise is likely over the next 12 months.
  • We believe the company’s recent study on nocturnal leg cramps (NLCs) may be flawed. We also highlight risks to its lead drug candidate, FLX-787, that we believe investors are currently overlooking.
  • We highlight several competitive available alternatives to FLKS’s cramp products that we believe investors have not factored into current valuation.
  • Only 2.82% of drugs from companies co-founded by CEO Westphal have achieved FDA approval.

The last bullet point refers to Flex Pharma’s CEO, Christoph Westphal MD PhD (described bi Fierce Biotech as "serial biotech entrepreneur"). Only two out of his 71 requests for FDA approval were successful.

On October 13th 2016 it was reported that early trials of FLX-787 had been disappointing. The shares plunged.

fp1

On October 17th 2016, Seeking Alpha posted another evaluation: “Flex Pharma Has Another Cramp“. Also StreetInsider,com. They were not optimistic. The former made the point (see above) that crossover trials are not what should be done. In fact the FDA have required that regular parallel RCTs should be done before FLX-787 can be approved.

Summary

Drug discovery is hard and it’s expensive. The record for small molecule discovery has not been good in the last few decades. Many new introductions have, at best, marginal efficacy, and at worst may do more harm than good. In the conditions for which understanding of causes is poor or non-existent, it’s impossible to design new drugs rationally. There are only too many such conditions: from low back pain to almost anything that involves the brain, knowledge of causes is fragmentary to non-existent. This leads guidance bodies to clutch at straws. Disappointing as this is, it’s not for want of trying. And it’s not surprising. Serious medical research hasn’t been going for long and the systems are very complicated.

But this is no excuse for pretending that things work on tha basis of the flimsiest of evidence, Bruce Bean advised me to try Hotshot on friends, and says that it doesn’t work for everybody. This is precisely what one is told by homeopaths, and just about every other sort of quack. Time and time again, that sort of evidence has proved to be misleading,

I have the greatest respect for the science that’s published by both Bruce Bean and Rod MacKinnon. I guess that they aren’t familiar with the sort of evidence that’s required to show that a new treatment works. That isn’t solved by describing a treament as a "dietary supplement".

I’ll confess that I’m a bit disappointed by their involvement with Flex Pharma, a company that makes totally unjustified claims. Or should one just say caveat emptor?

Follow-up

Before posting this, I sent it to Bruce Bean to be checked. Here was his response, which I’m posting in full (hoping not to lose a friend).

"Want to be UK representative for Hotshot? Sample on the way!"

"I do not see anything wrong with the facts. I have a different opinion – that it is perfectly appropriate to have different standards of proof of efficacy for consumer products made from general-recognized-as-safe ingredients and for an FDA-approved drug. I’d be happy for the opportunity to post something like the following your blog entry (and suffer any consequent further abuse) if there is an opportunity".  

  " I think it would be unfair to lump Hotshot with “dietary supplements” targeted to exploit the hopes of people with serious diseases who are desperate for magic cures. Hotshot is designed and marketed to athletes who experience exercise-induced cramping that can inhibit their training or performance – hardly a population of desperate people susceptible of exploitation. It costs only a few dollars for someone to try it. Lots of people use it regularly and find it helpful. I see nothing wrong with this and am glad that something that I personally found helpful is available for others to try. "

     " Independently of Hotshot, Flex Pharma is hoping to develop treatments for cramping associated with diseases like ALS, MS, and idiopathic nocturnal leg cramps. These treatments are being tested in rigorous clinical trials that will be reviewed by the FDA. As with any drug development it is very expensive to do the clinical trials and there is no guarantee of success. I give credit to the investors who are underwriting the effort. The trials are openly publicly reported. I would note that Flex Pharma voluntarily reported results of a recent trial for night leg cramps that led to a nearly 50% drop in the stock price. I give the company credit for that openness and for spending a lot of money and a lot of effort to attempt to develop a treatment to help people – if it can pass the appropriately high hurdle of FDA approval."

     " On Friday, I sent along 8 bottles of Hotshot by FedEx, correctly labeled for customs as a commercial sample. Of course, I’d be delighted if you would agree to act as UK representative for the product but absent that, it should at least convince you that the TRP stimulators are present at greater than homeopathic doses. If you can find people who get exercise-induced cramping that can’t be stretched out, please share with them."

6 January 2017

It seems that more than one Nobel prizewinner is willing to sell their names to dodgy businesses. The MIT Tech Review tweeted a link to Imagine Albert Einstein getting paid to put his picture on tin of anti-wrinkle cream. No fewer than seven Nobel prizewinners have lent their names to a “supplement” pill that’s claimed to prolong your life. Needless to say, there isn’t the slightest reason to think it works. What posesses these people beats me. Here are their names.

Aaron Ciechanover (Cancer Biology, Technion – Israel Institute of Technology).

Eric Kandel (Neuroscience, Columbia University).

Jack Szostak (Origins of Life & Telomeres, Harvard University).

Martin Karplus (Complex Chemical Systems, Harvard University).

Sir Richard Roberts(Biochemistry, New England Biolabs).

Thomas Südhof (Neuroscience, Stanford University).

Paul Modrich (Biochemistry, Duke University School of Medicine).

Then there’s the Amyway problem. Watch this space.

Jump to follow-up

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

Can you trust Boots?
Don’t Trust Boots
Boots reaches new level of dishonesty with CoQ10 promotion

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.

Boots rubbish

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.

Jump to follow-up

Today is a good day for anyone who deplores dangerous confidence tricksters. In particular it is a good day for Ben Goldacre, and for the Guardian which defended him at potentially enormous expense.

Matthias Rath, the Dutch (or is it German) vitamin salesman has dropped his libel action against the  Guardian. He is the man who is, without doubt, responsible for many deaths form AIDS in Africa, as a result of peddling vitamin pills as cures.  The action was taken after Goldacre said, in the Guardian, that Rath  aggressively sells his message to Aids victims in South Africa that Rath vitamin pills are better than medication”.

Here is some of what has appeared already today

Fall of the doctor who said his vitamins would cure Aids – from The Guardian, with a video of the villain.

Goldacre’s Badscience blog article on his victory .

Leader from The Guardian .

Profile of Zackie Achmat – from The Guardian, Mr Achmat is the founder of the Treatment Action Campaign , instrumental in exposing Rath.

Extract from witness statements from the defence in the trial .

And a lot of publicity from Gimpyblog (“Ben Goldacre and The Guardian triumph over murderous Matthias Rath”), Holfordwatch , Quackometer and jdc325 blogs.

Then more in the Guardian the next day, Chris McGreal investigates the Rath Foundation

Nutritional therapist?

Let’s be clear about what the words mean.  Nutritional therapists are not like dietitians, and they are not like nutritionists.  Nutritional therapists are solidly in the camp of alternative medicine practitioners,  Don’t
take my word for it. They say so themselves.

“For nutritional therapists (who practise Complementary and Alternative Medicine) optimum nutrition encompasses individual prescriptions for diet and lifestyle in order to alleviate or prevent ailments and to promote optimal gene expression through all life stages. Recommendations may include guidance on natural detoxification, procedures to promote colon health, methods to support digestion and absorption, the avoidance of toxins or allergens and the appropriate use of supplementary nutrients, including phytonutrients.”

They love to use imaginary words like “detoxification”, and, much more dangerously, they love to pretend that they can cure diseases by changes in diet. As long as you buy from them a stack of expensive “supplement” pills, of course. That means they are selling medicines, but by pretending they are selling food supplements they manage to evade the law that requires medicines to be safe and effective.  That will not be so easy under new legislation though, and we can look forward to a few prosecutions soon.

Guess who runs an “Honours BSc degree” in Nutritional Therapy. No prizes for realising it is the UK’s leading university purveyor of woo.

The University of Westminster

On their web site we learn that the Course Leader is Heather Rosa, and the Deputy Course Leader is Val Harvey.  Harvey qualified in the subject at the Institute  of Optimum Nutrition, the private college run by none other than the famous pill-peddler, Patrick Holford, about whom so very much has been written (try Holfordwatch, or the masterly chapter in Goldacre’s Bad Science)

We don’t know much about what is taught on the Nutritional Therapy course because the University of Westminster has refused repeated requests to say (but watch this space).. One can only assume that,  whatever it is, they are not very proud of it.  It seems a little unlikely that they will go as far as Matthias Rath and claim to cure AIDS -we’ll just have to wait and see.  Meanwhile we can get an inkling by looking elsewhere.

Course leader, Heather Rosa, pops up for example, on the expert panel of a web site called Supplements Compared.com. “Supplements Compared is designed to help you find the best dietary supplement product for your health needs.”   And what sort of advice do you find there?  Try the page that compares 10 brands of CoQ10 (that is the stuff I wrote about recently, in “Boots reaches new level of dishonesty with CoQ10 promotion” – their advertising was deemed improper by the ASA ).  It isn’t a recommended treatment for anything at all, but you certainly wouldn’t guess that from what is written by the ‘expert panel’.  The winners are, according to the ‘expert panel’, Boots’ CoQ10 and Holland and Barrett’s CoQ10.   Winners?   Perhaps the explanation for that comes elsewhere, under “How are we funded?”.   “Manufacturers who are awarded “best product” and “worth a look” are given the opportunity to promote this fact throughout the site for an additional fee.”. Well well.

Deputy Course leader, Val Harvey has her own web site and business (I do hope thar Westminster does not pay these people a full time salary too). What can we glean from there? It has the usual scare tactics “Why
you are at risk?
“. Never fear; buy enough vitamin pills and you’ll be saved.

Her home page makes some pretty drastic claims.

“Potential health benefits of your nutritional programme

An appropriate Nutritional Programme can benefit many conditions including:

Allergies

Arthritis

Asthma

Bloating, indigestion

Chronic degenerative diseases

Chronic fatigue, ME

Constipation, diarrhoea

Cystitis

Depression, mood swings

Digestive or bowel problems

Eczema, psoriasis, other skin problems

Food sensitivities

Frequent infections

Hormone imbalance
Hypertension or elevated cholesterol

Irritable bowel syndrome

Low energy

Menopausal symptoms

Migraines, headaches

Parasitic and fungal infections

Pre-conceptual issues

Premenstrual syndrome (PMS)

Sinus congestion

Stress

Thrush

Weight problems

and many others ….



These are just some of the wide range of health problems that may be helped by nutritional therapy. Even those who consider themselves well and healthy may be able to enhance their physical and mental health, as well as their performance, including athletic performance, by improving their nutrition.”

There is, in my view, not the slightest bit of good evidence that swallowing vitamin pills can benefit most of these conditions.

But at least the list doesn’t contain AIDS, so is all this really relevant to the case of Matthias Rath?

Yes, I believe it is. The University of Westminster may well not support the views of Matthias Rath (they won’t say), but we have heard no choruses of protests about him from any nutritional therapists, as far as I’m aware. There is no mention of him at all on the web site of the British Association of Nutritional Therapists (BANT), the UK club for these people.  BANT, by the way, has a rather curious code of ethics. It allows its members to take undisclosed financial kickbacks for the pills they prescribe to patients. If doctors were caught doing that they’d be struck off the register.

It is the existence of degrees in subjects like “nutritional therapy” that gives the subject a spurious air of respectability which allows seriously dangerous people like Rath to flourish with very little criticism.  In an indirect way, the vice-chancellors who allow it to flourish (and Universities UK who do nothing about it) must bear some small part of the responsibility for the deaths of thousands of people from AIDS.

It is about time they did something about it.

Follow-up

ANH. The first reaction from the supplement-peddling industry comes from the Alliance for Natural Health on 16th September. It contains not one word of condemnation for Rath’s murderous activities. It’s hard to believe how low they will sink.

The Prince’s Foundation for Integrated Health remains totally silent about Rath. HRH’s concern for health seems to dry up if things don’t suit his views.

The British Association of Nutritional Therapists shows it’s total irresponsibility after a letter was sent to them to ask about their reaction. Their answer , on jdc325’s weblog was “The association has no opinion to offer on Dr Raths vitamin trials.”.


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