NEWS: Call to test new consumer law
New legislation that aims to protect UK consumers from being misled by unjustified health claims looks set to collide with the 2006 bill which allowed homeopathic medicines to claim they can cure disease. The consumer protection regulations that came into force on 26th May [1] this year target unfair selling to consumers by any business. The new bill will implement new pan-European rules on unfair commercial practices, and will also be the first of its kind to cover claims made on the Internet. Experts have welcomed the new legislation but wonder whether sufficient resources will be made available to enforce it.
Of specific interest to HealthWatch members is the fact that the new ruling will cover any items—such as pills, drinks or creams—that claim to have beneficial health effects. If a trader cannot prove scientifically that the product works, his activity will be treated as a commercial practice that is unfair to the consumer. The Office of Fair Trading (OFT) and Trading Standards will be expected to enforce the new rules, which could include substantial fines and jail sentences, depending on the seriousness of the offence.
Some experts doubt the legislation will have the intended impact. Jack Winkler, professor of nutrition policy at London Metropolitan University, writing in the British Medical Journal [2] said that, “offenders have deeper pockets than the upholders of the law. This is a generic problem that hobbles all the torrent of food legislation that has emerged from the EU since 1992, including the specific new rules on nutrition and health claims.” If the legislation is not strengthened and properly resourced at national level, he says, “then all their protestations of concern about obesity and other diet-related problems are just more empty rhetoric—a new type of political false claim.”
HealthWatch committee member, clinical scientist Les Rose, is keen to put the new legislation to the test, particularly with regard to homeopathic remedies whose labels could now be considered to breach it. “As most readers will know, new regulations introduced in September 2006 allow homeopathic products to carry indications for use without having to provide any evidence for that claim. Homeopathic manufacturers have until 2013 to comply fully but in the meantime, current licence holders can choose to accept a licence under the new rules, which allow indications for ‘mild, self-limiting conditions’ (i.e. ones that get better anyway). You might therefore continue to see ‘Homeopathic Insomnia Tablets’, with a product licence beginning with PLR (a licence of right issued under the Medicines Act 1968 when it came into force in 1971).”
So what happens if someone decides to challenge whether a homeopathic product works for insomnia under the new consumer legislation? Rose continues, “My guess is that Trading Standards will bounce the whole thing off to the Medicines and Health Products Regulatory Authority (MHRA). But I’m not at all sure, so I will be testing this pretty soon. I hope lots of HealthWatch members will do so too.”Rose is not convinced that the resources or indeed the will currently exist to enforce the new ruling. But he points out that EU member states firstly have a duty to enact legislation that has been passed by the European Parliament, by transposing EU Directives into national law. “You might remember that the Directives on Clinical Trials and Good Clinical Practice caused rather a stir at first, but the UK Statutory Instruments that enact them are now well established, and are enforced via the MHRA inspection team. Today, you can quite literally go to jail for persistent serious breaches of Good Clinical Practice. Has the government put anything in place to enforce the consumer legislation? There is no evidence yet to say yes to that.”
Les Rose raised the matter with his MEP Dr Caroline Jackson (Con), who said, “If you feel that the UK is not properly enforcing this legislation you can complain to the Secretary General of the European Commission, who highlight the fact that they welcome such complaints as a valuable form of monitoring EU law in Member States.” Les Rose concludes, “I strongly recommend that you all test the new law by notifying both Trading Standards and the Office of Fair Trading about spurious health claims. Please note that, for the first time, it is now clear that websites are within the scope of the legislation, as indeed are TV, radio, shop windows, point of sale promotions. If you have evidence that action is not being taken, complain to the European Commission and copy in your MEP. Handled properly, we have been given more weaponry against pseudoscience than we have ever had before.”
References
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NEWS: Dilute response to homeopathy campaignThe homeopathy awareness group H:MC21 has raised fewer than 5% of its target number of signatures for its “homeopathy works” campaign. H:MC21, short for “Homeopathy: Medicine for the 21st Century” has campaigned since September last year to raise 250,000 UK signatures to a declaration that states, “homeopathy worked for me”, by the target date of June 2008.
The campaign was designed to counter negative publicity against homeopathy, for example the extensive media coverage given to the May 2006 letter from 13 scientists to primary health care trusts asking them to restrict NHS spending to evidence-based treatments (see HealthWatch Newsletter issue 62, July 2006). Pressure brought by the letter and the resulting publicity has probably contributed to the threatened closure of a number of NHS homeopathy services and the withdrawal of NHS funding to the Tunbridge Wells homeopathic hospital from the end of last year.
The website,http://www.hmc21.org/, suggested that, “Everyone in the UK of any age who has benefited from homeopathy can add their name to this declaration”. As of Thursday 12 June 2008 (the date given on the website when HealthWatch’s editor accessed it on 23 June 2008) the petition had collected 3,289 written signatures, with another 8,037 online, altogether representing 4.5% of the target. H:MC21 now suggests on its website that it might be possible to reach the target by next June.
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ASA News
Wholegrain cereal and chiropractic ads “misled”
Wholegrain “3-a-day” recommendations could mislead, and chiropracters should not claim success in treating arthritis, were among the conclusions of the Advertising Standards Authority in June.
A television ad for Nestlé breakfast cereals, placed by Cereal Partners UK of Welwyn Garden City, Hertfordshire claimed, “Experts say you need three servings of wholegrain a day…”
The UK Food Standards Agency, advising the ASA, accepted that UK adults need to eat more fibre but found the claim, “Experts say…” contentious. In fact the claim is backed by some US experts, for example the American Dietetic Association state that adults should consume three 16 g portions of wholegrain foods per day. However because there are no formal UK Government recommendations on daily quantities of wholegrains the ASA upheld the complaint. They also considered viewers could confuse the “3-a-day” phrase used in the ad with the Government’s “5-a-day” recommendation for fruit and vegetables (ASA report, 11 June 2008).
A chain of chiropractic clinics are to be allowed to claim success in treating migraine, but not whiplash, arthritis or chronic pain. The regional press advertisement for BritChiro Clinics Ltd, of Horsham in West Sussex, stated, “When Getting Better Matters...” and targeted sufferers from ailments including those above.
On expert advice the ASA considered there was sufficient evidence to support the use of chiropractic for migraine. However the evidence submitted for whiplash and arthritis did not include any controlled studies, so there was no way of knowing if any effect was placebo. BritChiro Clinics agreed to remove references to whiplash, arthritis and also to chronic pain from future advertisements.
The ASA also considered that the use of the term “Dr” in relation to chiropracters who are not medically qualified doctors was likely to mislead and should be removed (ASA report, 28 May 2008).Details of ASA adjudications can be found online at: http://www.asa.org.uk/asa/adjudications/Public/
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News in brief
Glasgow GP and journalist Margaret McCartney is to be the sixteenth winner of the HealthWatch Annual Award for her articles, in publications including the Financial Times and the British Medical Journal, which have contributed to understanding of health issues. In an article in the BMJ recently she highlighted the dangers of the growing trend to halt clinical trials early because of initial good results. The award will be presented at the 2008 HealthWatch Annual General Meeting, to be held on Tuesday 14th October. Further details will be sent to members in due course.
Read her FT articles at:
The BBC has removed all the 40-odd alternative medicine pages from http://www.bbc.co.uk/health/, “as part of a wider review of all the health content in order to enable the BBC to focus its efforts on creating new and exciting content.” Read the full statement on: http://dcscience.net/?p=224
The popular use of gluten- and/or casein-free diets for autism is not supported by evidence of efficacy, says a Cochrane review published in April. The exclusion diets are widely used by parents in the belief that elements of their child’s autism might be explained by excessive opioid activity linked to peptides from gluten and casein. However the reviewers found only two reports of randomized controlled trials (totaling 35 subjects) that had mixed results and lacked important details. Full report on: http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD003498/frame.html
This follows the highly-publicised extensive Cochrane review concluding that “current evidence does not support the use of antioxidant supplements in the general population or in patients with certain diseases.” Access on: http://www3.interscience. wiley.com/cgi-bin/mrwhome/106568753/ CD007176.pdf
The rector of the Medical University of Vienna has asked researchers at his university to withdraw their two publications based on faked data supposedly showing that electromagnetic radiation from mobile phones causes DNA breakage in human tissue cells. The studies, published in 2005 and 2008, had caused alarm about the health risks from mobile phones. In a statement the university said a laboratory technician from the department of occupational medicine confessed to fabricating the data.
BMJ 2008; 336: 1270 (7 June)Public fears over a cancer link with MRI scanners are groundless, say experts from the British Institute of Radiology. The May 2008 publication by the Advisory Group on Non-Ionising Radiation (AGNIR) concluded that there is no evidence of harmful effects from static magnetic fields. However press coverage following the publication focussed on the plan to carry out studies amongst workers to collect detailed data. This, says the BIR, is good practice and not being done because of evidence pointing to any detrimental health effects. Access on: http://www.hpa.org.uk/webw/HPAweb&HPA webStandard/HPAweb_C/1211184025666?p=1199451989432 and http://www.bir.org.uk/mri_safety _news_concerns.html
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Research: Good science, bad science, fun science and the Kohn brothersTwo remarkable Polish scientists distinguished themselves in their fields yet will be remembered for the younger brothers’ contribution to scientific humour and an irreverent awards ceremony that is now a household name
Many readers will know of the Annals of Improbable Research and the Ig Nobel prizes: they are run by Marc Abrahams, a Harvard mathematician, but were founded by Alexander Kohn, an Israeli virologist who died in 1987. A chance remark by HealthWatch member Vincent Marks, that he knew Kohn’s brother Joachim, provoked my interest in the Kohns.
Joachim was born in Poland in 1912 and qualified in medicine at Lwow University in 1936. He served in the Polish army and was captured by the Soviets, who in 1939 took him and 22,000 others to Katyn, inside the Russian border, to be shot. The bodies of 4,500 of these officers were found in mass graves many years later; most had their hands tied behind their backs and all had a single bullet hole in the back of their head.
Joachim was one of the few who escaped. He was fluent in several languages, probably including Russian, and—in one of the most remarkable tales I have ever heard—made his way thousands of miles across Russia to the Bering Sea. It took him two years. He presumably was without money or possessions, and must have bartered his medical skills to survive. He crossed the Bering Islands to Canada and enlisted in British army in 1941.
His brother Alexander, seven years younger, was born in south-east Poland and emigrated to what was then Palestine in 1937. He studied microbiology at the Hebrew University in Jerusalem and was a member of the Hagana, the Jewish paramilitary organisation. Fearing the fate of the Jewish people in WWII he, too, joined the British army, probably in 1940. I do not know when the brothers discovered that each other was still alive and fighting in the same brigade. Alexander served in Israel, North Africa and Italy until 1946. Joachim served until 1947 in the Middle East and Italy as medical officer and then as commanding officer of a field ambulance company. He invented a first aid and transport burns dressing that became the standard for the British army. He was awarded two medals for bravery: the Polish Gallantry Cross and Silver Order of Merit with Swords.
Alexander resumed his studies at the Hebrew University and gained a PhD in 1952 for a thesis on the behaviour of microorganisms in the air. He did some of the research at Harvard medical school.
Many well-qualified Poles, perhaps including Joachim, found it difficult to get work in Britain after the war. In 1949, two years after he was demobbed and a year after the NHS was founded, he was appointed to the clinical pathology staff at Queen Mary’s Hospital, Roehampton, SW London. He became consultant in 1955, also working at the Institute of Cancer Research and St Anthony’s Hospital, Cheam. He set up support services for burns injuries, including establishing the Special Protein reference Centre at Putney Hospital and was its first director. He was member and chairman of the WHO Action Committee for supporting services on burns injuries, and did considerable research on the topic. He retired in 1977 and immediately became visiting professor of immunochemistry at Surrey University, where he taught and researched until days before his sudden death in 1987.
Known to his colleagues as Jim, his strong character was tempered by kindness and modesty. He is best known for inventing cellulose acetate electrophoresis but also made major contributions in clinical chemistry and immunology, thermal injury and diagnostic microbiology. He was fluent in half a dozen languages and could make himself understood in several others.
Alexander, nicknamed Leshek, joined the Israel Institute for Biological Research in 1952 and was made head of biophysics within two years. He then rose to professor of microbiology at Tel Aviv University and was director of the IIBR. He did sabbaticals in Berkeley, Chicago and London’s Institute of Cancer Research. He did important research on viral vaccines for human and poultry disease, virus–cell interactions, and fluxes of materials through membranes. The latter led to diagnostic materials made by Orgenics, an Israeli biotechnology company.
Alexander wrote six books including False Prophets: fraud and error in science and medicine, and Fortune or Failure: missed opportunities and chance discoveries in science. These were best-sellers and were translated into several languages.
He did some humorous science writing, and in 1955 started the Journal of Irreproducible Results with a colleague, Harry Lipkin. It fell into other hands and withered to near-extinction. In 1990, Marc Abrahams, a Harvard mathematician, mailed them some articles to see if they would print them. A few weeks later he got a phone call asking him to be the editor. Leshek Kohn had suggested the term Ignoble prize, and this led to the Ig Nobels, an annual award ceremony at Harvard for science that makes you laugh and then makes you think, AIR (the Annals of Irreproducible Results) and mini-AIR, the free monthly email version. The Ig Nobel show tours Britain every March.
Leshek worked until shortly before his death in 1994 of non-Hodgkin’s lymphoma.
Caroline Richmond
Author and Medical JournalistFurther reading
For more about the IgNobel awards, described by Nature as “arguably the highlight of the scientific calendar,” see:
The Annals of Improbable Research Web site on http://www.improbable.comFollow the online instructions to subscribe to free e-newsletter, mini-AIR.
A brief history of the IgNobel prizes as a celebration of the world’s wackiest scientific research:http://www.msnbc.msn.com/id/3088163/Read about last year’s IgNobel awards, at which a UK radiologist won first prize for a study into the side-effects of sword-swallowing, at http://www.guardian.co.uk/science/2007/oct/05/1
Past IgNobel prize winners are listed on:http://improbable.com/ig/ig-pastwinners.html
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TREATMENTS: Do you really need those antibiotics?
You cannot have failed to see, while sitting in your doctor’s surgery or waiting at the pharmacy counter, notices advising you that antibiotics are not effective against the common cold. Because of the many problems associated with the prescription of antibiotics which can give rise to significant side effects, and the development of resistant organisms (of which MRSA is the well known example), there is a concerted effort by the Department of Health to restrict their use.
In a 2007 issue of the Drugs and Therapeutics Bulletin [1] (the “Which” Guide for doctors), an article aiming to reduce the use of antibiotics in general medical practice outlines the ways in which their use can be restricted. Not only do the general public need education but also the prescribing practitioners. In the article antibiotics are referred to as antibacterials, which helps to emphasise the fact that they are not effective against viruses. In many conditions seen in primary care, antibiotic treatment is of limited value and the benefits are out-weighed by the potential unwanted effects of allergies, development of bacterial resistance and there is also a risk of death from anaphylactic shock. Conditions for which antibiotics might be inappropriately prescribed include the common cold, sore throat, acute earache, acute infective conjunctivitis, acute bronchitis and acute sinusitis. NICE [2] have considered the use of antibiotics for earache and they are not recommended routinely. (For those of us interested in evidence-based medicine it is good to read that not only are antibiotics not recommended, but neither is homeopathy, massage, cranial osteopathy or other alternative therapies.)
It is quite clear that, in areas where antibiotics are most used, there is an increase of organisms that are resistant to antibiotics. The number of prescriptions for antibiotics varies widely across Europe. For example in Greece 3% of the population is taking antibiotics on any one day. Whereas in the Netherlands, the figure is below 1% and England it is around 1.5% [3]. Although the prescribing rate for antibiotics has reduced from 1995 to 2000, this reduction has levelled off or may even be increasing again.
In an aim to reduce their use, both patient and practitioner education has been tried. In the Journal of Antimicrobial Chemotherapy [4,5] a survey was taken of the public attitude toward taking antibiotics. Although many patients realised that they are not effective against viruses, it is very difficult to convince them that antibiotics will not help them in some way. It is also obvious that although there are always clear instructions to complete a course of antibiotics, many patients do not do so, and keep a few spares to take in case they have another infection!
One of the most effective ways in General Practice to reduce the demand from patients is to advocate the use of delayed prescribing. At their initial appointment, the patients are given analgesics or similar medication for a week to reduce their symptoms and asked to return for antibiotic medication only if the symptoms have not cleared. This has reduced the number of antibiotics prescribed for the common cold, acute earache, sore throat or bronchitis.
The use of formularies, which guide doctors in prescribing habits, can have a limited effect on what is used. In Australia the costs of patients’ prescriptions are re-imbersed by the Health Insurance Commission. They noted that a particular type of antibiotic was being used inappropriately. Practitioners were informed that the Commission were going to look very closely at practitioners who continued to use it. As a result the number of courses of this particular drug dropped considerably, however at the same time the pharmaceutical companies were heavily promoting two other related drugs and—not surprisingly—their use increased reciprocally.
In dentistry there has been a sea change in the prophylactic use of antibiotics. For the last sixty years or more every dental student, every doctor and every cardiologist has been taught that any patient with a heart murmur or any heart lesion has to have antibiotic cover for dental extractions, even for a scale and polish. A child with the slightest heart murmur was therefore routinely given antibiotic cover when any dental extractions were to be carried out. The rationale behind this was that taking a tooth out causes a shower of bacteria to spread around the blood stream, with the possible risk that the bacteria settle on damaged heart valves and cause Infective Endocarditis. This is a rare condition and despite advances in treatment it is still a life threatening disease with a mortality of 20%. There have been many studies, however, which have thrown doubt as to whether dental extractions or scaling and polishing can in fact produce a bacteraemia sufficient to cause Infective Endocarditis. In fact it is now shown that even brushing your teeth can cause a shower of bacteria equal to that following an extraction. It is clearly implausible that an extraction would be more likely to cause infective endocarditis than tooth brushing.
In 2006 an editorial in the British Dental Journal [6] shook the dental world when it reported the advice of the British Society for Antimicrobial Chemotherapy which made it quite clear that there are only a few patients who require such antibiotic cover—those with some serious heart conditions. Those with heart murmurs, which are fairly common, do not require antibiotic cover for dental extractions or any advanced dental treatment. This produced a rash of letters to dental journals in the following months from practitioners, some of whom remembered a case where a patient had died from Infective Endocarditis following a dental extraction. Many wrote to explain that they prescribed antibiotic cover for extractions in such cases to ensure that they would not be liable for damages. In the past the General Dental Council admonished one dental practitioner who had treated a patient with a heart murmur and failed to give antibiotic prophylaxis. To confuse matters more there was conflicting advice from the British Cardiac Society, The European Society for Cardiology and the American Heart Association and College of Cardiology, all of which continued to recommend antibiotic cover for patients with an existing cardiac pathology. Unfortunately it was considered to be quite unethical to attempt to conduct double blind controlled studies. As a result of the considerable confusion in the dental and medical world by the conflicting advice, the Chief Dental Officer referred the matter to NICE and kicked the whole subject into touch.
NICE have now reported [7] and their recommendations are quite clear that there is little evidence to support the practice of antibiotic cover for dental extractions and other interventional procedures. It has not been proven to be effective. Indeed, cases have been reported where patients have been given prophylactic antibiotics for dental procedures and still developed Infective Endocarditis. In fact there is no close association between episodes of Infective Endocarditis and interventional procedures. Therefore antibiotic prophylaxis is no longer offered routinely for defined interventional procedures. There are a few patients with severe structural heart defects for which this may be indicated but these are in a considerable minority.
Now that NICE has reported, finally the Protection Societies (who insure doctors and dentists for their clinical work) have written a guidance note to all dental practitioners explaining that to prescribe antibiotics in these cases, far from being negligent, would render them culpable.
It is going to take time to change attitudes because patients with heart murmurs are used to being told that they should have antibiotic cover. They carry cards to tell them they should have antibiotic cover and dental practitioners are used to prescribing it. So if you do have a heart murmur and you are about to have a dental procedure, and antibiotics have been used for extractions in the past, please check with your Dentist or Doctor to find whether this still applies to you!References
Keith Isaacson
Senior Consultant Orthodontist
North Hampshire Hospital, BasingstokeTop of page
TESTING: Applied kinesiology and the DIY RCT
Twenty years ago a young catering manager at a tertiary educational college asked me for help. She was required to cater for about 150 resident students, but so many had food allergies that it was virtually impossible to devise menus that were tolerable to all of them. She told me that the diagnosis of food allergies had been made by a local GP who provided medical care on the NHS for the students.
He used applied kinesiology (AK) to make the diagnosis, and made no charge for this service. The students felt much better after excluding the detected toxic antigen (usually a food colour, cereal or dairy product) so they were unwilling to revert to their previous diet. What should she do?
I visited the GP to ask about the reliability of AK, which comes in several versions. His method, learned from another local GP, had the patient hold in his right hand a series of sealed glass vials that each contained a common food antigen. Weakness of the left arm signified a toxic effect of the antigen in that vial. From his own experience he was satisfied that the test was clinically useful and reproducible, and his tutor had tried to publish this research, but mainstream medical journals refused to do so. I asked if he would be willing to do a trial jointly: I was confident I could get it published somewhere if my statistical colleagues could design the test.
He agreed enthusiastically. Whenever he obtained a positive reaction in a patient to one or more of the 12 open label vials he should test the same subject with a set of vials containing the same antigens but which were labelled A to L, but arranged in a different order. I provided (at a cost to myself of £15 in 1988) the two sets of vials, and a chart on which to record positive reactions to both the open label and coded vials for 20 sequential patients. It took 11 weeks to complete the results chart. The GP was perplexed, since he could not find a consistent relationship between the open and coded responses. In fact the 12 coded vials contained (in random order) duplicates of the five most common antigens and two vials with saline but no antigen at all. My colleague Doug Altman meticulously analysed the data and failed to find any respect (apart from that expected from chance) in which the response in the open label vials agreed with the same antigen in a coded vial.
The GP accepted that AK, as practised by him, could not be a reliable method for diagnosing food intolerance, so he ceased to use it and the prevalence of intolerance decreased among the students in his practice. The caterer was happy, and it became easier to feed the students at the college. So the remaining challenge was for me to get the data published in an “orthodox” medical journal. I asked the GP if he wished to be lead author, but he was ambivalent about authorship in view of the (to him) surprising outcome. It was agreed that I should be sole author in any published report, but we were both named in a poster session of the Nutrition Society.
I submitted a short report to The Lancet and received a prompt reply from a friendly editor saying they had other copy with higher priority for publication. I met the editor concerned at the annual British Medical Journal Christmas party and was agreeing that his response was perfectly justifiable when our host, Richard Smith (who was soon to become editor of the British Medical Journal and much later winner of the 2004 HealthWatch Award), joined us and was told the story again. To my surprise he asked me to send him the short report. He published it [1].
his trivial Yuletide anecdote may have some relevance to our views on current evidence-based medicine, although in 1988 ‘EBM’ was an unknown topic. For example:
Despite a continuing lack of evidence of efficacy of AK it is still promoted
by kinesiologists. Indeed a few years ago Lord Baldwin invited me to a meeting
at the Houses of Parliament to demonstrate the usefulness of applied kinesiology
in detecting toxins in the parliamentary tap water. My suggestion was welcomed
that the demonstration would be much more compelling if a blind comparison was
made with control samples of non-toxic water, but so far as I know this has
never been done.
John Garrow
Emeritus Professor of Human Nutrition
University of London
Reference:
1. Garrow JS. Kinesiology and food allergy. BMJ 1988, 296: 1573.
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MEDIA: Alternative Therapies Revisited
The BBC’s second attempt at examining alternative medicine, screened on 17th, 24th and 31st March, was an interesting contrast to the first series which had attracted much criticism. It was clear that the Beeb was not going to take any risks this time, after it was found to have broadcast open heart surgery giving the impression that it was conducted solely under acupuncture anaesthetic.
The second episode dealt with reflexology. Professor Sykes revealed that, despite supposed links with thousand-year-old practices, the technique was actually invented by one Eunice Ingham in the 1930s. Next, an anatomist thoroughly dismissed the possibility of any connection between the sole of the foot and the organs that reflexologists claim are connected with it. An attempt was made to define the difference between anecdotal evidence from happy customers of reflexologists, and clinical trial evidence (there isn’t any), but there was rather too much time spent on the practice of a British lady who specialises in treating infertility. A garden party overrun with bouncing babies and beaming parents was a powerful image, except when Kathy speculated as to how many couples remained childless and thus didn’t qualify for the party.
It was refreshing to see an—albeit too short—interview with our good friend Ray Tallis, who made the important point that practices like reflexology are harmful in that they mislead people as to how science works, how the body works, and how the universe in general works.
Moving onto the subject of touch therapies, what emerges is that massage engenders relaxation and a feeling of well-being, whether it’s general body massage or just the feet. At Harvard, Ted Kaptchuk talked eloquently about the placebo effect, and of the powerful effects of context and ritual in patient interactions. Bodily contact was shown to generate changes in brain imaging which relate to reduction in stress.
Rather like the first episode, the last considered a modality which I would not normally consider alternative medicine. We have the Beatles to thank for bringing transcendental meditation into the public arena (yes, I am old enough to remember), and in all those years since the Swinging Sixties I have never thought of it in a physical health context. The programme kicked off with a sort of pilgrimage to ‘the happiest man in the world’, a Buddhist monk in Nepal who, rather disappointingly, turned out to be French. He tried to teach medication technique to Kathy who, refreshingly, could not suppress the odd giggle.The air miles continued to rack up as we whizzed off to North America for Kathy’s session on the couch, wired up to instruments which showed how her vital signs responded to stress, and dramatically improved when relaxed. Why didn’t I find this surprising? Then the programme descended into silliness, with a visit to the Maharishi Vedic City in Iowa. Population: 500 residents, and apparently all the houses are designed according to Vedic rules, to promote relaxation. But it was the yogic flying that got both Kathy and me laughing out loud. We were told quite seriously by a normal looking chap that levitation can be achieved, but that of course we wouldn’t be seeing that today. I suspect that Kathy was having too much trouble suppressing mirth to ask why. The demonstration consisted of a number of cross-legged men bouncing across a huge mattress on their bottoms. I did bristle a bit when I learned that the meditation course offered by the Maharishi Vedic City costs well over $2,000, and that the US government has given the organisation $20 million for ‘research’. We weren’t told about any of the research they are doing. Sounds a bit like the Men Who Stare at Goats to me.
Next, and for the first time in either series, we were told where to look for proper evidence. Both individual clinical trials and systematic reviews were very briefly explained, and PubMed searching demonstrated. You will not be surprised that Kathy didn’t find any solid evidence for the health claims of meditation. This was probably the most important bit of the programme, but I suppose most viewers will have found it the least interesting.
Back on the road again, to see some more brain imaging studies, this time quite intriguing and seeming to show that there really is something going on when people meditate. Not only does brain activity change in specific areas, but structural changes appear to have been demonstrated. But overall, the impression I got was that meditation devotees seem to spend a huge proportion of their lives doing nothing.
It was a bit disappointing that it took until the last of six programmes in the two series to provide any significant material on where to look for evidence of health claims. This should surely have been nearer the beginning, with all subsequent claims stacked against it. The message of the series, at least to my perception, was that various techniques can have profound effects on how we feel, which correlate with actual changes in the brain. I don’t see this as in any way surprising. The brain is what we are, in terms of personality. It is where we process sensory data and where we feel emotions. We certainly should be researching these effects, and looking for ways of using them to alleviate suffering. But I was continually looking for Kathy Sykes to ask whether it’s acceptable to lie to patients about how their body works—and she never did. The height of her indignation was the phrase “It troubles me....”, when considering groundless claims. She made it clear that the claims were groundless where this was the case, but there was no sense of outrage at the hijacking of science by people making money out of misleading the vulnerable. The series had substance, but lacked passion for the truth.Les Rose
Freelance Consultant Clinical Scientist
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Book review
TRICK OR TREATMENT? Alternative Medicine on Trial
Written by Simon Singh and Edzard Ernst. Hardcover, 352 pages.
Published by Bantam Press (2008) at £16.99 ISBN-10: 0593061292 ISBN-13: 978-0593061299Regular readers of the HealthWatch Newsletter have probably heard of this book already. The authors should need no introduction. Edzard Ernst is a previous winner of the Healthwatch award and is the world’s first professor of complementary medicine, based at Exeter University. Simon Singh is a well known science journalist and author. Both wanted to answer the question, “Is alternative medicine effective for treating disease?”
The book is good; very good. It is well researched and written with in a most readable style. The authors start with an introduction to science and scientific methods; by explaining the rationale of experiment the reader is introduced to randomised controlled trails, cohort and observational studies and the concept of evidence based medicine. I was most impressed that difficult concepts such as these were explained so clearly. They then study acupuncture, homeopathy, chiropractic therapy and herbal medicine in detail. Each has its own chapter where the origins of the therapy, its development, acceptance and practice are discussed. Then the therapy is scientifically evaluated and we discover whether there is any evidence that it works in treating disease. Each of these chapters has a short conclusion which summarizes the main points. The authors then discuss does the truth matter, the placebo effect and give their own Top Ten culprits of the promotion of unproven medicine. The appendix briefly reviews nearly all of the other alternative therapies.
The results are largely predictable; few of the alternatives work. However I was surprised to see that Echinacea does help in the treatment and prevention of the common cold and that garlic helps reduce high cholesterol. The book is a most useful source of detail on alternative treatments and is comprehensive in it coverage. Personally I would have liked to see more references.
The history of the development of alternative medicine and that of scientific thinking was fascinating. I was aware of Cochrane and Snow but had no knowledge of Florence Nightingales’s statistical prowess. You will have to read the book to discover how the first ever controlled clinical trial invented by Lind prevented the invasion of Britain by Napoleon. I was left wondering why he is not recognised as a national hero.
I have said that the book reads well but there is arrogance; in their introduction the authors describe the book as “the world’s most honest and accurate examination of alternative medicine”. They are also confident that their book offers an “unparalleled level of rigour authority and independence”.I was troubled by a sense of negativity throughout the book. Many chronic illnesses that cause much disability and loss of life have no validated treatment in conventional medicine. The authors dismiss the use of the placebo effect as unacceptable. Where does this leave many patients? I have known people with terminal cancer discharged from clinic “because we have no treatment which works”; hardly good care to send them away to die. The so called “heart sink” patients with chronic problems which cannot be treated with any conventional medication still need help; are we to dismiss them because we have nothing to offer? Medicine remains an art, not a science, and it’s not surprising given the time constraints within the NHS that many turn to alternative medicine where they perceive themselves to be listened to and understood. Easy to do if the patient is paying £100 an hour! The challenge, not addressed by this book, is how to manage these problems within the current health care system and stop the exploitation of the vulnerable.
Gillian Robinson
Associate Specialist in Sexual and Reproductive Health
St Giles Hospital, LondonEditor’s note:
“Trick or Treatment?” was extensively reviewed on the booksellers Amazon.co.uk website, where some members of the HealthWatch Committee also offered robust replies to those critical of the book.
Professor John Garrow described the book as a long-awaited, “thorough audit by competent unbiased clinical scientists to see if these myth-based treatments actually did the patient any good.”
Les Rose commented, “Nobody should consider any alternative therapy without reading this book. Of course, alternative therapists should as well, but they won’t and will just carry on condemning it.”
Former HealthWatch Awardwinner Professor Michael Baum, emeritus professor of surgery and visiting professor of medical humanities at University College London, praised the book’s description of the transparency and intellectual honesty of scientific method. He quotes Galileo, “The object of our science is not to open the doors to infinite wisdom but to set limits to our ignorance”, and concludes, “this book serves us well by setting a limit to our ignorance about the nature of disease and its palliation.”
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MORE NEW BOOKS ON THE CAM BOOKSHELF
“Trick or Treatment” is one of several books published recently on the subject of complementary and alternative medicine. Others include:
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LETTER TO THE EDITOR: Value of health treatments: a vexed issue
2007 HealthWatch Awardwinner Professor Raymond Tallis here concludes his discussion with Gillian Tindall. Our thanks to both writers for this thought-provoking exchange:
I am very grateful to Gillian Tindall for her letter, “On Tallis’ difficult moral questions” (HealthWatch Newsletter issue 69, April 2008) because it gives me the opportunity to make one or two points that could not be accommodated in an article which kept to the commissioned length.
The issue of cost-effectiveness is a very vexed one. It is difficult—but not impossible—to calculate comparative cost-effectiveness of different drugs or, more broadly, health technologies. If finite resources are available, then it is not merely appropriate but, or so it seems to me, morally imperative to ensure that more cost-effective technologies are favoured over less cost-effective ones. By that means, we will ensure that resources made available to the NHS deliver maximum health gain.
Of course, things are not quite so simple as that. Firstly, many treatments have slipped through “on the nod” without being exposed to cost-effectiveness evalution. Secondly, it is evident from NICE’s decisions that the use of NHS resources is not nakedly utilitarian. I am pretty sure that if we lowered the upper limit at which technologies are available on the NHS to below £30,000 per QALY, we would get more value for money. The world, however, would be a crueller place. Thirdly, there is the issue of 'orphan diseases' such as congenital enzyme deficiencies which, in virtue of their rarity, are always going to expensive to treat. (Drug companies will charge more for drugs for which there is a small market).
Finally, there is the politico-ethical question as to how much taxpayers are willing to pay in order to fund each others’ need for care. I discussed all these issues in a paper I gave to the Royal College of Physicians at a session chaired by our President Nick Ross. One of the conclusions I drew was that not even a John Rawls approach, based upon the notion of distributive justice, would solve the dilemmas faced by NICE. In the absence of a solution to the ethical issues, we have to be pragmatic and try to move towards the most cost-effective use of existing resources. Saying “Yes” to things that don’t work or offer very little would mean saying “No” to things that do work or work better.
As regards Gillian’s second point, I may have been misunderstood. I was not suggesting that we should sacrifice individuals to the greater good—we know where that leads—but acknowledge that a treatment that works extremely well in most people, and thus brings overall benefit to the population being treated, may have unacceptable adverse effects in a small minority. Where the media sometimes fail is that they may focus on the latter and overlook the former. I for example have had very unpleasant experiences with statins and cannot tolerate them. It would be wrong if, on the basis of my unhappy experiences, I were to launch a media campaign against statins which seem (so far) to be delivering huge health benefits to other people with high cholesterol. We should not ignore, or over-ride, individual experiences; indeed, the experience of those who feel a treatment has injured them or their loved ones should prompt review of the evidence of overall benefit.This is what post-marketing surveillance is all about.Yours sincerely
RAYMOND TALLISTop of page
Holford resigns Teesside University visiting professorship
Media nutritionist Patrick Holford has resigned from his post as Visiting Professor at Teesside University. A spokesman for the university told the HealthWatch Newsletter, “Due to changes in the academic structure of the University of Teesside’s School of Social Sciences & Law, Patrick Holford has chosen to resign from his status as a Visiting Professor.”
Holford, who has a BA in Psychology, is described on his own website as, “a pioneer in new approaches to health and nutrition, specialising in the field of mental health” and says that he, “is widely regarded as Britain’s best-selling author and leading spokesman on nutrition and mental health issues.”
Holford was conferred the Visiting Professorship in the university’s School of Social Sciences and Law last year.
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Opinions expressed in letters and articles published in the HealthWatch Newsletter belong to the authors and do not necessarily reflect the views of HealthWatch. The editor reserves the right to amend text if necessary but will, where possible, consult the author to ensure accuracy is maintained. Letters and articles for publication are welcomed and should be sent to the Editor by e-mail to: newsletter@healthwatch-uk.org
Copyright © 2008 HealthWatch.