Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
Universities
The latest Cochrane review finds no good evidence that acupuncture or acupressure are effective for stopping smoking
Read more on the original IMPROBABLE SCIENCE page
The Health Supplements Information Service (HSIS) is a spin organisation for the supplements industry. I came across them when they attempted to discredit a report that supplements could actually increase mortality. In that case Ann Walker spoke for HSIS.
The same Ann Walker wrote an editorial for the British Journal of General
Practice (January 2007), “Potential micronutrient deficiency lacks recognition in diabetes”. The conclusion is “Although still considered to be controversial by some, taking a daily multinutrient supplement would bridge the gap between intake and requirements and ensure that nutrient target intakes are met”. The affiliation given is senior lecturer in nutrition at the University of Reading, where she has a one-tenth full time appointment. No competing interests are declared. The University of Reading tells me that she has “consultancies for two supplement companies and for the Health Supplement Information Service. Dr Walker has also declared a private patients clinic”.
Ann Walker is also course director for an organisation called New Vitality. And she “operates a Clinic from her home on two days a week, using a combination of nutritional therapy and herbal medicine to treat patients with a wide variety of conditions.” All this sounds rather less academic.And so it is. Take red clover. New Vitality’s view is shown on the right What on earth is a “blood cleanser” or a “cleanser of the lymphatic system”. This is so much meaningless gobbledygook. The term “blood cleanser” means nothing whatsoever.
An enquiry about what “blood cleanser” means has yet to produce a reply.
The description of red clover on the New Vitality site
And is red clover really good for “symptoms of the menopause”? There is quite a different view on Medline Plus. This is an information service run by the US National Library of Medicine and National Institutes of Health. They say, of red clover for menopausal symptoms,
“most of the available human studies are poorly designed and short in duration (less than 12 weeks of treatment).As results of published studies conflict with each other, more research is needed before a clear conclusion can be drawn.”
Medline Plus lists six other indications for red clover that have been suggested
by herbalists. The conclusion in all seven cases is “Unclear scientific evidence for this use”
Likewise, New Vitality says of elderflower
“The primary use of elderflowers is for colds and influenze where its anti-viral properties come into play.”
But Medline Plus says
“it remains unclear whether there is truly any benefit from elder for this condition. Additional research is needed in this area before a firm conclusion can be reached. Elder should not be used in the place of other more proven therapies, and patients are advised to discuss influenza vaccination with their primary healthcare provider. It should be noted that the berries must be cooked to prevent nausea or cyanide toxicity.”
Thia item was posted originally on the old IMPROBABLE SCIENCE page
Twenty-five hospitals from London and southern and eastern England have already either stopped sending any patients to the Royal London Homeopathic Hospital or agreed to fund only a handful A campaign has started o save it, but the arguments are far from convincing.
This is reposted from the original IMPROBABLE SCIENCE page
The news is out. It was in February this year when I first saw some “Commissioning Intentions 2007-08” documents from several London NHS Primary Care Trusts (PCT), indicating their intention to break their contracts with the RLHH on the very reasonable grounds that homeopathy doesn’t work. It seemed better to wait for the intentions to be implemented before saying much, because of the inevitable outcry from those who want sugar pills at the taxpayers’ expense.
Then, in March 2007, the Health Services Journal carried a story “PCTs consider alternative to homeopathic hospitals” (free registration, or read it here).
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On 8 April 2007, The Observer carried a special report, prominently featured on page 3.
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 Fisher and Queen, Observer 8 April 2007 |
Peter Fisher, clinical director of the RLHH, is quoted as saying
“Twenty-five hospitals from London and southern and eastern England have already either stopped sending any patients to the RLHH or agreed to fund only a handful.”
“Prince Charles is sympathetic, supportive and concerned. But he doesn’t feel it’s appropriate to intervene in any way because there’s been some adverse publicity before about him ‘meddling’. ”
Fisher attributes this to the letter sent to PCTs by 13 of us, last May, in which we advocated that the NHS should not be paying for “unproven or disproved treatments”. The leading signatory on this letter, Professor Michael Baum, is quoted in the Observer thus.
“If the Royal London were to close because of PCT deficits we would scarcely miss it”.
“Homeopathy is no better than witchcraft. It’s no better than a placebo effect. It’s patronising and insulting for adults.”
“Instead you could have a centre for palliative and supportive care, which would be of greater benefit and involve half the cost. Rather than losing something, we would gain something.”
The backlash
The reaction seems to have started with a letter from homeopath Carol Boyce. Her letter starts thus.
| ROYAL LONDON HOMEOPATHIC HOSPITAL UNDER SIEGE “Death by stealth. The Royal London Homeopathic Hospital (RLHH) – the visible presence of homeopathy within Britain’s NHS – an institution putting homeopathy in the public mind for the last 150 years – the place where homeopathy was seen to perform so well in the cholera epidemic of the 1840s – is being dealt a DEATH BLOW” |
I’d guess the very first sentence must be something of an embarrassment to the RLHH’s clinical director, who is far too sensible to believe that cholera can be cured by homeopathic sugar pills.
The red herring about cholera is repeated ad nauseam on hundreds of homeopathy sites (though most are curiously silent about whether they really believe that sugar pills can cure cholera). It is based on the report that during the London Cholera epidemic of 1854, of the 61 cases of cholera treated at the London Homeopathic Hospital, 10 died (16.4%), whereas the neighbouring Middlesex Hospital reported 123 deaths out of 231 cases of cholera (53.2%). Apart from the lack of any knowledge of the state of the patients on entry to hospital, it was also the case at the time that conventional medicine was no more based on evidence than homeopathy. Indeed the initial popularity of homeopathy could well have resulted not only from wishful thinking, but also because doing nothing at all (i.e. homeopathy) was less harmful than blood letting. The fallacy of the argument was spotted very early on by Oliver Wendell Holmes (senior) in his famous essay, Homeopathy and its Kindred Delusions.
But medicine moved on and homeopathy didn’t. The history of cholera, like that of tuberculosis, contrary to what is suggested by homeopaths, is a triumph for evidence based medicine. The epidemic was halted not by homeopaths but by the careful observations of John Snow that led to his removing the handle of the Broad Street pump. If medicine had been left to homeopaths, people would still be dying of these diseases.
Carol Boyce invites you to write directly to Queen Elizabeth II, to save the RLHH. She has also started an e-petition on the UK government site. The petition includes the words
| ROYAL LONDON HOMEOPATHIC HOSPITAL UNDER SIEGE
“The RLHH has been part of the Health Service for 150 years. ” “In 2005, 67% of GPs and 85% of practices in it’s [sic] Primary Care Trust, referred patients to the hospital. The hospital provides effective and most importantly, COST-EFFECTIVE treatments.” |
Ms Boyce seems not to have noticed that the Prince of Wales’ own Smallwood report decided that there was not enough evidence to come to firm conclusions about cost-effectiveness.
Peter Fisher himself has appealed for the survival of the RLHH in a letter dated 9 March 2007 [download copy of letter].
“The Royal London Homoeopathic Hospital needs your support
09/03/2007By Dr. Peter Fisher, Homeopath to Her Majesty, the Queen.
There is no silly talk about cholera here, but there is a useful list of Trusts who have decided to abandon "unproven and disproved treatments". Fisher recommends you to read Marcia Angell’s book to learn about the deficiencies of the drug industry. I recommend that too. I also recommend Dan Hurley’s book on the even greater deficiencies of the quackery industry.
Fisher suggests you write to your MP to prevent closure of the RLHH.
I suggest you write to your MP to support closure of the RLHH.
The Times Higher Education Supplement (THES) published another bash at BSc degrees in anti-science. This one was accompanied by a defence from Brian Isbell, head of the department of complementary therapies at Westminster University. Isbell’s defence was different from Westminster’s first defence, but every bit as unsatisfactory, in my view.
Following the kerfuffle caused by Nature, THES asked for 800 words on the same topic, Bachelor of Science degrees in subjects that are anti-science (read it here). Every time I read an official validation document I am reminded inexorably of the inimitable Laurie Taylor, which is why the article starts thus.
| The vice-chancellor of Poppleton University is pleased to announce that the university’s finances have been transformed since the conversion of its old-fashioned department of physics and astronomy into the new department of alternative physics and astrology. Quality is ensured by the course validation and top Quality Assurance Agency rating, both awarded by a distinguished panel of academics with appropriate expertise in astrology. (Apologies to Laurie Taylor.) |
As it happens, Laurie Taylor’s column in the same issue of THES is on “Maintaining Standards”, and is as grimly hilarious as always. And his column in the following week (13th April) was about the report of the external examiner, Professor J.K.L. Anonymous, on the Universlity of Poppleton’s BSc in palmistry (“There were 36 first-class papers, 22 upper seconds and only one marginal failure”. Well, there’s a coincidence.
My piece ends thus.
| If a few vice-chancellors appear to value bums on seats more than honest science they should justify their views in public. |
THES plans soon to bring us some responses from the hitherto elusive vice chancellors. That should be interesting. Well they should have been interesting, but all but four of the sixteen letters that were sent by THES were ignored entirely, and the four replies that were received were deemed to be too boring to publish.
| This was accompanied by an article by Brian Isbell, who is head of the department of complementary therapies at Westminster University. He presumably had a hand in the (unsigned) response of Westminster to the Nature article, but this time the response was rather different (could that be because he’d read my comments on the original response?). This time there was no quoting of bad evidence, or the Society of Homeopaths, but rather a defence based on the fact that BSc degrees in CAM include some real scientific content. Let’s take a look at this new response. Isbell says |  Brian Isbell |
| “The shared philosophy across Westminster’s range of complementary therapy degrees is that students need a compulsory core of health sciences. This includes anatomy, physiology, biochemistry, pathology and differential diagnosis. Phytochemistry and pharmacology are included for degrees in herbal medicine and nutritional therapy.” Brian Isbell |
So on Mondays and Thursdays (for example) the students must believe that response increases with dose, but on Tuesdays and Fridays they are called upon to believe that response decreases with dose.
Isbell admits as much himself when he says “at times students have to work with conflicting scientific models that may not always fit with their clinical practice”. What he does not say is how this absurd conflict is resolved, or how it can be made compatible with science or simple common sense. The course evidently teaches you how to believe several mutually contradictory things at the same time, or at least on alternating days. You don’t need to be a scientist to see that is plain daft.
Not only are some of the doctrines of CAM incompatible with science or common sense, but they are often also incompatible with each other. Homeopaths subscribe to the bizarre doctrine that the less you give the bigger the effect, but herbalists do not. Herbal medicine is nothing other than pharmacology, albeit pharmacology as practised at the beginning of the 20th century, before biological standardisation was introduced to assure constant potency of medicines. So they want to give a sensible dose, but don’t know what it is. Nutritional therapists go to the opposite extreme and want to give huge (and sometimes toxic) doses.
I have been told that herbal medicine students at Westminster are instructed not to talk to the homeopaths in another part of Isbell’s school, because they talk rubbish. They even have separate sections on the university’s intranet, so that one sort of CAM can’t be polluted by the beliefs of a different sort of CAM. Likewise, students of reflexology are taught that a small area on the big toe is connected with the pituitary gland. Not only is this incompatible with physiology, but it is also incompatible with homeopathy, herbal medicine and nutritional therapy.
The department of complementary therapies seems to resemble a collection of religious sects at war with each other, rather than anything recognisable as science.
The second plank in Isbell’s new defence is that students are taught to develop research skills. Homeopathy students get one course (out of 22) called “Methods of Research in Complementary Medicine”, and a project, “Research in Practice”. It is impossible to know what is taught on these courses because the university refuses to release any of the course materials. But I find it hard to imagine that the courses are very critical when the official response from the university cited the Spence (2005) study as though it provided evidence for the efficacy of homeopathy.
If that is the best the teachers can do, what hope is there for the students?
The day after “Science degrees without the Science“ appeared in Nature, the University of Westminster issued a statement . In my view, their statement provides the strongest grounds so far to believe that the BSc is inappropriate.
Let’s take a look at it.
| “The BSc (Hons) Health Sciences: Homeopathy is a fully validated degree that satisfies internal and external quality assurance standards.” |
Well, since the University has so far refused to release any of the documents, it is hard to judge that that validation is worth. The validation documents will, no doubt, appear eventually. Watch this space.One mechanism that is intended to maintain the standard of degrees is the external examiner. Their identities, like almost everything else, are kept secret. In the case of the Westminster BSc in homeopathy, however, we are in luck. According to the Teaching Quality Information (TQI) site, their external examiner is the “Chair of the Society of Homoeopaths”. Since April 2004, that has been Andy Kirk RSHom, a homeopath in private practice, with no degree and no scientific qualifications. He, I imagine, is not likely to question the bizarre homeopathic doctrine that the smaller the dose you give, the bigger effect you get.Correction (4 April 2007). It seems that Westminster supplied wrong information to the TQI site, and the external examiner is not Kirk. They refuse to say who it is. But watch this space.
| “The University’s stance received the backing of the Society of Homeopaths, the UK’s largest register of professional homeopaths”. |
Yes, I’m sure it did. The Society of Homeopaths is an organisation for homeopaths who have no medical qualification. Their scientific credentials can be judged from this quotation from their web site.
“If they are so dilute, how can they work?
After each dilution the mixture is vigorously agitated in a machine that delivers a calibrated amount of shaking. This is called succussion. It is thought that this process imprints the healing energy of the medicinal substance throughout the body of water (the diluent) as if a message is passed on. The message contains the healing energy.”
This is pure gobbledygook. The word “energy” is being used in a way unknown to science. It is mere armwaving in an attempt to ‘explain’ a phenomenon that almost certainly doesn’t occur anyway.
| “In fact there is considerable evidence demonstrating the clinical effectiveness of homeopathic treatment, including a large outcomes study published in 2005, of an analysis of over 23,000 outpatient consultations at the Bristol Homeopathic Hospital, in which more than 7 per cent reported clinical improvement,” |
(Notice the Freudian slip. That should be 70%)
The study to which they allude here has to be the worst paper ever published. It is the infamous Spence (2005) study. Oddly enough, this paper is one that Westminster students were asked to assess critically. Sadly, though, it hasn’t been possible to see any marked answers.
The fact that this is the best evidence that the University can produce in response to criticisms is, perhaps, the best reason ever to think that the material being taught is not, in any sense, science, and is not appropriate for a BSc. It seems that they are hoist by their own petard.
A TV company funded a rather uninformative study of omega-3 fish oil by Prof Basant Puri if Imperial College and the Hammersmith Hospital. The media reports on the study were totally misleading It was not revealed that Prof Puri is named as “inventor” on a paten for the fish oil formulation, as discovered by Ben Goldacre.
Read more on the original IMPROBABLE SCIENCE page
The media reports on the alleged advantages of drinking purple grape juice were uniformly misleading. The study by Alan Crozier did not measure health benefits but was a chemical analysis. Its interpretation in terms of health were arguably over-optimistic.
Read more on the original IMPROBABLE SCIENCE page
This is reposted from the old IMPROBABLE SCIENCE page
The British Medical Journal (2007, 337, 508 – 509) held a debate on whether or not CAM should be referred for evaluation to the National Institute for Clinical Excellence (NICE) [see it here]. Two of the comments that followed the debate were as follows
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John R King, Consultant Psychiatrist David Colquhoun (“NICE should not have to evaluate alternative medicine”) makes a better case than Linda Franck et al. Space researchers do not, after all, waste time trying to disprove the beliefs of flat- earthists. Neither would it be helpful for a Nobel prizewinning chemist to stride into a church and denounce the holy water there as nothing more than H2O. There is a very large and ever expanding array of alternative treatments, some more bizarre than others, which could tie up the resources of NICE for an indefinite period. But if people want to believe in them – or in fairies or leprechauns – they should be left in peace to do so. It is no concern of scientific medicine. |
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David Colquhoun, UCL Nobody is proposing to ban fairies or leprechauns. It would be both undesirable and impossible. There does seem to be a case, though, for not providing leprechauns at the tax payers’ expense. And really all leprechauns that are sold to the public should have labels that don’t make false claims for their powers. Unfortunately the MLRA (Medicines and Leprechauns Regulatory Agency) has let us down in the matter of labelling. I suspect infiltration of the Department of Health by little green men |
Channel 4 TV, Monday 12th March. This is the title of the Channel 4 TV documentary, Dispatches.
Lord Wedderburn, QC, a life peer and Emeritus Professor of Law at the London School of Economics, tells the programme:
“If, in fact, nothing changed and he became King, then there would be a most almighty fuss and controversy, and eventually the whole fabric of the constitutional monarchy could be threatened.”
The Prince’s Foundation for Integrated Health (FIH) is the Prince’s lobby group which attempts to make the hard-pressed NHS spend more money on unproven and disproved treatments. The FIH publishes “Complementary Healthcare: a Guide for Patients”. This document is not just barmy, but positively dangerous. In the rebuttal of the programme on the FIH web site, they claim that they do not promote alternative medicine, but elsewhere on the site they state their aim as “makes safe and effective complementary therapies available to patients in conjunction with conventional healthcare”.
Which would be all very well if they didn’t consistently ignore the evidence for effectiveness.
The MHRA recently, for the first time, betrayed its brief to nake sure that medicines work and are safe. This action has been condemned by just about every professional organisation. Nobody knows exactly what caused them to lose their heads in this way, but it is clear that they were under pressure from both the Department of Health and from the Prince of Wales. The Department of Health is clearly sympathetic to quackery, as shown by the letter below, and by their refusal to allow alternative medicine to be referred to NICE for assessment.
| The MHRA admit to having had at least seven letters form the Prince of Wales, and we know that an MHRA member has met the Prince at Clarence House at least once. But all the contents are secret from the public. The Chairman of the MHRA Agency Board, Prof Alasdair Breckenridge, and chairman of their Herbal Medicines committee, Prof Philip Routledge, have both admitted to me to having had pressure from the Prince of Wales, but neither will give any details, despite having been condemned by their own professional organisation, the British Pharmacological Society. |  |
The Pharmacological Society’s statement read thus.
| The British Pharmacological Society believes that any claim made for a medicine must be based on evidence, and that it is the duty of the regulatory authorities, in particular the MHRA, to ensure that no claims can be made for the efficacy of any form of medicine unless there is good evidence that the claim is true. Despite many years of investigation, we have no convincing scientific evidence that homeopathic remedies work any better than placebo. Pharmacologists have noted frequently that most homeopathic products are diluted to the extent that they contain no molecule of active ingredient, that is, no medicine, which is highly misleading to consumers who are unlikely to recognise the expression “30C” for example. Furthermore, there are serious concerns, even in cases where they are used for minor ailments, that officially endorsed use of such remedies may put patients at risk of delayed diagnosis. The Society is therefore surprised that the national rules scheme for licensing homeopathic products, which came into force on 1 September (Statutory Instrument 2006 1952), will regard non-scientific data as evidence of efficacy. |
An excellent article on this topic was published by Rose in The Biologist, British health care regulation moves away from science.
The appalling treatment of Professor Edzard Ernst
| Edzard Ernst was the UK’s first professor of complementary medicine, and he is rather unusual in that field because he is totally honest, and very careful about evidence (something that has not always endeared him to the alternative medicine industry).
A letter was sent from Clarence House to the vice-chancellor of Exeter University, Steve Smith. The letter alleged a breach of confidence by Ernst. Having been sent a draft of the Smallwood report, Ernst was so horrified by the scientific standards in that document, he felt obliged, in the public interest, to speak out about it. Ernst was contacted by a newspaper, which had a copy of the draft, and described the initial findings as “outrageous and deeply flawed”. He added: “It is based on such poor science, it’s just hair-raising. The Prince … also seems to have overstepped his constitutional role” |
Prof Edzard Ernst. |
Prof Ernst was doing exactly what academics are meant to do. As a result he was subjected to a very prolonged disciplinary procedure, and for a year it was not obvious whether he’d keep his job. For a Prince, in a constitutional monarchy, to put pressure on a university to silence a conspicuously honest academic is just not acceptable.
The Prince of Wales behaviour was bad enough, but, to be generous, he is perhaps, a well-meaning but poorly educated man, filling in his time as best he can.
| In the story of Edzard Ernst, the behaviour of the Vice-Chancellor of Exeter University, Prof Steve Smith seems to me to be unforgivable. Instead of supporting his staff, and supporting academic freedom, he appeared to cower before the Clarence House letterhead. After keeping Prof Ernst on tenterhooks for an entire year he eventually deigned not to fire him in the most grudging and unpleasant way imaginable. |
 Prof. Steve Smith, Vice chancellor. |
That is illustrated by the end of Smith’s letter to Professor Ernst on 13th October 2006. It was shown on the TV programme, and is reproduced below.
Click to enlarge
The Daily Mail also has features on the healthiness of HRH’s own food lines, after his criticism of MacDonalds, Dutchy Original Sins, and here.
They are worth reading because the advice comes from Catherine Collins, a real dietician, not a nutribollocks guru.
Some responses The story was reported round the world.
Max Hastings (Guardian)
“To make good use of evidence, it is essential to possess not only intelligence, but a capacity for disciplined analysis. The prince has considerable virtues, a good heart notable among them. But he has always lacked discipline in his life and in his treatment of issues. Again and again, he gets himself into trouble by seeking to address matters that are, frankly, beyond his intellectual reach.”
This post has been transferred from the old IMPROBABLE SCIENCE page.
Two interesting papers. One shows popular anti-oxidant ‘supplements’, beta carotene, and vitamins A and D, far from making you live longer, have the opposite effect. Another shows that garlic does not lower cholesterol. And some publicity for Dan Hurley’s book, Natural Causes. An update looks at the activities of the supplements industry spokesperson. Dr Ann Walker, who seems sometimes to forget to declare her interests.
First let’s reiterate the myth of antioxidants
Nutribollocks: the antioxidant myth
“Nutritional supplements” are one of the most profitable scams (see, for example, Healthwatch, Quackwatch, and Holfordwatch).
There is a nice article by Lisa Melton on The Antioxidant Myth: a medical fairy tale in tne New Scientist (and see here), [download as pdf] . Here are some quotations.
| Cranberry capsules. Green tea extract. Effervescent vitamin C. Pomegranate concentrate. Beta carotene pills. Selenium. Grape seed extract. High-dose vitamin E. Pine bark extract. Bee spit.You name it, if it’s an antioxidant, we’ll swallow it. According to some estimates around half of US adults take antioxidant pills daily in the belief that they promote good health and stave off disease. . . . In 1992 researchers at the US National Cancer Institute set about testing beta carotene. The trial was set to run for 6 years, but two-thirds of the way through the researchers pulled the plug after discovering, to their surprise and horror, that those taking supplements were doing worse than the controls. They had developed 28 per cent more cases of lung cancer, and their overall death rate was 17 per cent higher. It’s a similar story with the world’s most popular antioxidant. Vitamin E shot to fame in the early 1990s, after two large studies involving more than 127,000 people in total found that those with a diet high in vitamin E were significantly less likely to suffer cardiovascular disease. Use of vitamin E supplements soared. In 1990, almost nobody took vitamin E; by the end of the decade an estimated 23 million US citizens were knocking back daily doses. |
“Treatment with beta carotene, vitamin A, and vitamin E may increase mortality”
That is the conclusion of a recent paper in the Journal of the American Medical Association, “Mortality in Randomized Trials of Antioxidant Supplements for Primary and Secondary Prevention” Systematic Review and Meta-analysis”, [Get the full text].
This isn’t original research, but a meta analysis that attempts to collate existing data taking into account the reliability of each source. The aim was to analyze the effects of antioxidant supplements (beta carotene, vitamins A and E, vitamin C [ascorbic acid], and selenium) on deaths (from any cause) in adults. The analysis seems to have been done well, and the results are startling. They aren’t just a waste of money, but some of them are actually bad for you. In 47 low-bias trials with 180 938 participants, beta carotene increased death rates by 7 per cent, vitamin A by 16 per cent, and vitamin E by 4 per cent (when taken separately). Vitamin C gave contradictory results and selenium showed no detectable effect.
This work got an excellent write-up in The Times, by their health correspondent, Nigel Hawkes. This was followed by a predictably silly defence of nutribollocks by the Times’ Dr Thomas Stuttaford (known in Private Eye as Dr Utterfraud). Luckily, this was neutralised by a second piece on the same page by Nigel Hawkes, “Phooey. Sensible balanced diet is the best investment”:
“ In nutrition, a plausible idea and a little bit of evidence are all that is needed to create a market. And such is the megaphone of marketing and the influence of countless “healthy eating” articles that these ideas, even the half-baked ones, can lodge very firmly in the national psyche.”
It’s a nice coincidence that this study came out while I was reading Dan Hurley’s book, Natural Causes (see below). This book sets out dramatically the harm, sometimes serious harm, that untested “supplements” have done to some individuals. But for me the most interesting part is the revelation of the political lobbying by this $20 billion supplement industry, with the aim (largely successful) of undermining the FDA and escaping from any effective regulation of its absurd, but exceedingly profitable, claims. The supplements industry puts the Prince of Wales in the shade when it comes to subverting common sense and good science.
The Health Supplements Information Service (HSIS)
Needless to say, the supplements industry has already organised vilification of this excellent bit of work.
According to their web site,
“HSIS is funded by The Boots Company PLC, Bayer PLC, Perrigo, Seven Seas Ltd and Wyeth Consumer Healthcare. The campaign is co-ordinated by PAGB (Proprietary Association of Great Britain)”.
So it’s no surprise that their spokesperson. Dr Ann Walker, immediately tried to discredit the study, saying “The results of these mixed-sample metaanalyses are worthless” (The Times).
This same Ann Walker recently wrote and editorial in the British Journal of General Practice (January 2007). The editorial concludes “Although still considered to be controversial by some, taking a daily multinutrient supplement would bridge the gap between intake and requirements and ensure that nutrient target intakes are met.” But in this editorial her affiliation is given as Senior Lecturer in Human Nutrition, University of Reading. No mention at all of her role as spokesperson for the Supplements industry. Tut tut.
Patrick Holford too
Needless to say, supplement salesman Patrick Holford has weighed into the vilification. His objections have been dealt with nicely on the cutely named web site stopholfordtalkingrubbish.blogspot.com. Find the answers here.
Holford is the man who, in the BMJ said “Competing interests: none declared”, when promoting his supplements.
No interests? Holford himself has said
“any product, be it a publication, seminar, food or supplement, that is authored/invented by me has my name on it and earns me a royalty/payment. That is how I live and fund my research.”
So what about the galaxy of supplements being sold at “Health products for Life”? They say “we only supply supplements, foods and drinks that are recommended by nutrition expert, Patrick Holford.” And at the bottom of the page it says “©Copyright 2007 Holford and Associates. All Rights Reserved”. Companies House lists the sole shareholder in ‘Health Products for Life’ as P.J. Holford.
Garlic is no good either
Another interesting recent paper has appeared in Archives of Internal Medicine
Garlic is widely promoted as a cholesterol-lowering agent, but the evidence so far has been lousy. In this trial, 192 adults with low-density lipoprotein cholesterol (LDL-C) concentrations of 130 to 190 mg/dL (3.36-4.91 mmol/L) were randomly assigned to one of the following four treatment arms: raw garlic, powdered garlic supplement, aged garlic extract supplement, or placebo.
“Conclusions None of the forms of garlic used in this study, including raw garlic, when given at an approximate dose of a 4-g clove per day, 6 d/wk for 6 months, had statistically or clinically significant effects on LDL-C or other plasma lipid concentrations in adults with moderate hypercholesterolemia.”
Another purveyor of nutribollocks who has been dissected and exposed by Ben Goldacre. His views on AIDS are a menace to humanity. And, incredibly his course has been accredited by the University of Bedfordshire (formerly known as the University of Luton).
Read full entry on the original IMPROBABLE SCIENCE page.
BBC’s You and Yours programme (a lunchtime consumer programme) ran a good piece on “Helps Stop Snoring”, a dubious herbal “remedy” for snoring. They picked up the story from my site. Listen to the programme [mp3 file]
“Helps stop snoring” claims to work on the basis of a clinical trial. But the trial is flawed in many ways. In addition the author, Dr Andrew Prichard, seems to have quite forgotten to mention that a Helen Prichard who lives at the same address holds 2000 shares in the company that makes this wonder cure. [transferred from old improbable science page].
My pharmacological curiosity was stirred by a TV advertisement for a spray that, it was claimed, could stop you snoring. It’s hardly a life threatening condition, but it can be marriage-threatening. But what’s in it, and does it work?
A visit to the web site of Essential Health Products Limited looks promising. Their claim is this.
“CLINICAL TRIALS
Many products claim to have undergone tests, but Helps Stop Snoring is the only natural snoring remedy in the UK have undergone to a full, double blind clinical trial, conducted by a practicing Ear,Nose and Throat Consultant Surgeon.
Lasting over 18 months, the trial involved 140 snorers and their partners, and the results showed a headline success rate of 82%. The trial was conducted by Andrew Pritchard FRCS, Ear Nose and Throat Consultant at the Royal Shrewsbury Hospital and one of the UK`s leading specialists in the field of snoring and sleep disorders.
In a further first for a snore remedy the results of the trial were published in Phytology Research, an international journal, in October 2004.”
This claim was not so easy to check because the manufacturer mis-spells both the name of the author and the name of the journal. The paper in question seems to be this. Prichard AJ., The use of essential oils to prevent snoring Phytother Res. 2004 18(9), 696-9 [get the pdf].
Sadly this paper is not very convincing. The paper does describe the work as “preliminary”, but the manufacturer’s web site does not. There’s a surprise. For those who are interested, here are a few details.
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140 adult snorers were recruited to the study via a snoring clinic. Snorers were randomly allocated to receive a metered dose of “Stop snoring “gargle, “Stop snoring ” spray or placebo gargle (there was no placebo spray at all). It isn’t obvious what placebo could mimic the peppermint, lemon, clove, thyme, eucalyptus and pine oils that the “remedy” contains (among other things). Their concentrations aren’t stated. The paper makes no mention of what was used as placebo, but Dr Prichard tells me “The content of the placebo could not be an essential oil. I have been told by the manufacturer that we used a sugar type mix”. Actually it contained water, sodium saccharin, polysorbate 20, potassium sorbate and citric acid. It would be have been obvious tor the patient whether they got the placebo or not.
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The comparison that is made is before and after in each treatment group, rather than comparing the groups. The eminent statistician, Stephen Senn, has some trenchant criticisms of this sort of experimental design.
Senn points out that “Having made the mistake of using the within treatment group to baseline comparison he ought to then use the Wilcoxon signed ranks test rather than the rank sum but he doesn’t say which”. The results are pretty odd too. In the placebo group, 4 out of 11 patients show a big reduction in snoring severity (Fig. 4). In the spray group, a smaller proportion, 5 out of 28 show a big improvement (Fig 2). The changes in the rest of the patients are mostly very small, but there are more slight improvements in the spray group than in the placebo group. The percent of patients that “improve” (by any amount, however small, is therefore bigger in the spray group than control, but the difference in mean snoring severity was much smaller
Financial interests in the snoring study
Sadly, it is essential to consider vested interests in drug assessment, as I have noted below (and here, and here). Prichard’s paper states openly that it was “Sponsored by Essential Health Products Ltd, 4 Top Farm Barns, Pitchford, Shropshire, SY5 7DW, UK.” That doesn’t mean it’s wrong, though the bias associated with sponsorship is well known,
But there is no mention of shareholdings
Companies House will, only £1, sell you company reports. The records show that Helen Jane Prichard, holds 2000 shares in Essential Health Products Ltd.
Is this just a coincidence of names? I think not. If you look up. Dr Andrew Prichard in the phone book, you see that his address is exactly the same as that of Helen Jane Prichard.
Oh dear: looks like yet another undisclosed financial interest in a clinical study.
Many thanks to the inimitable Ben Goldacre fot the totally over-the-top link to this item: it has done wonders for my hit rate.
Boots the Chemists is selling the same stuff True to their philosophy of making money and never mind the evidence, the “Boots Alternatives” range of snake oil products has, for £14.99, exactly the same stuff. They claim the Boots |
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Enquiries to Boots about this product have not been answered or have been answered inaccurately. See also below for Boots miseducation pages.
And here’s the ironical bit. Boots web site makes a big point about CSR (Corporate Social Responsibility). (Thanks to Sean
Kehoe for spotting this.)
“TRUST BOOTS
As you may have noticed, that’s the tagline which in 2005 we adopted as the sign-off to all our advertising. But it’s much more than just a slogan. It’s a concise statement of our entire corporate strategy. Our aim is to make Boots the world’s best health and beauty retailer, and we’re 100% clear that the unique trust in which we are held provides the key to achieving this. Which means, of course, that those two words are also the rationale for all our CSR activities. Everything we do that builds trust is good for our business; anything which could compromise it, a risk we can’t afford to take.”
Trust Boots to provide straight answers.
They must be joking.
BBC’s Panorama programme broadcast the content of secret emails. They show that GSK was aware of evidence the Seroxat increased risk of suicide in young patients, and suppressed it. They also showed that Prof Martin Keller’s paper on the topic was ghost-written by a PR firm working for GSK.
Moved to this blog from the old IMPROBABLE SCIENCE page: see Universities Inc
A debate was held at the Natural History Museum on “Does Homeopathy Work?â€. You can see it on streaming video. Peter Fisher gave a talk which, after shameless cherry-picking of the evidence, went on to explain that if a memory stick can hold a lot of information, so can water (I’m not kidding).
Read full entry on the original IMPROBABLE SCIENCE page.
The MHRA’s new policy towards CAM has already received a well-deserved drubbing in the House of Lords. Now have the first example of the MHRA allowing totally misleading labels to be put on over-the-counter treatements.
A press release dated November 8th 2006 gives the shocking news.
MHRA grants landmark registration for Traditional Herbal MedicineThe Medicines and Healthcare products Regulatory Agency (MHRA) has granted the first UK product registration under the European Directive on traditional herbal medicinal products. . Professor Kent Woods, Chief Executive of the MHRA said:“This first product registration is an important landmark. We hope that Atrogel Arnica Gel will be the first of many products to receive a traditional herbal registration. Our aim is to enable those consumers who wish to take herbal medicines to make an informed choice from a wide range of products which have been made to assured standards of safety, quality and patient information.” |
What is the evidence that Arnica Gel does the slightest good for the conditions that will appear on the label? The answer is essentially none. There are only two papers in Medline. The first shows no detectable effect of arnica gel (compared with vehicle alone) (Alonso D, Lazarus MC, Baumann L., Effects of topical arnica gel on post-laser treatment bruises. Dermatol Surg. 2002 Aug;28(8):686-8.)
The second paper claims a positive effect, but it is worthless because it was an open trial with no proper controls. (Knuesel O, Weber M, Suter A. Arnica montana gel in osteoarthritis of the knee: an open, multicenter clinical trial. Adv Ther. 2002 Sep-Oct;19(5):209-18.). The last author on this paper, incidentally, gives his address as Bioforce AG.
So yes, the MHRA’s press release is indeed a landmark. It is the first time that they have allowed a medicine to be labelled with a therapeutic claim when there is no reason to believe it to be true.
The bottom of the press release says (my emphasis) “The MHRA is the government agency that is responsible for ensuring that medicines and medical devices work, . . .”.
Uhm, surely some inconsistency there.
But no, Kent Woods tells me “The strap-line you refer to is a highly simplified statement of our role in making regulatory judgements based on risk/benefit analysis in the real world. ”
The bizarre behaviour of the MHRA is based on European Directive 2004/24/EC.This contains (para 6) the following prime example of pre-enlightenment thought.
“The long tradition of the medicinal product makes it possible to reduce the need for clinical trials, in so far as the efficacy of the medicinal product is plausible on the basis of long-standing use and experience. Pre-clinical tests do not seem necessary, where the medicinal product on the basis of the information on its traditional use proves not to be harmful in specified conditions of use.â€
Evidently the MHRA have decided to go along with the licence for snake-oil salesman that this provides. It isn’t clear that they were compelled to do so (MHRA’s response here).
This is what the packet looks like. On the right, one panel is enlarged. The claim “It helps relieve symptoms including:” is quite outrageous. There isn’t the slightest reason to believe anything of the sort. I know the bit above that says “based exclusively on long-standing use”, but it certainly won’t be obvious to most shoppers that this is meant to imply that the clear claim that “it helps to relieve symptoms” may be so much nonsense.
