Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Homeopathy and snake oil
- Stephen J Evans (22 May 2009)
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Harm from homeopathic preparations: the French drug agency is more cautious.
- Alain Braillon (25 May 2009)
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Homeopathic quality control: Homeopathic not only in name, but in nature.
- Peter J Flegg (26 May 2009)
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Homoeopathy and snake oil? Or study first and judge later?
- Dr Viera Scheibner (31 May 2009)
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Prior Plausibility is a Problem
- Michael F Vagg (1 June 2009)
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The labelling allowed by the MHRA is probably illegal
- David Colquhoun (2 June 2009)
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Re: Prior Plausibility is a Problem
- Neville W Goodman (3 June 2009)
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Homeopathy doesn't do anything, which may be useful
- Nicholas Moore (4 June 2009)
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Surprised by MHRA on Amica Homeopathy
- S Pervaiz (3 July 2009)
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Stephen J Evans, Prof of Pharmacoepidemiology LSHTM, London WC1E 7HT
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It is tragic that we now have a respected body, the MHRA, granting a license for a product for which there is not only no evidence of efficacy but for which there is good evidence against any efficacy.
I have some sympathy with the MHRA in the face of a European Directive which has to be obeyed but which is almost totally irrational.
However, I think that because "efficacy" appears in that Directive and where there is evidence AGAINST efficacy then they could have resisted granting a license.
This fiasco takes us back to the days before drug regulation was introduced, partly to prevent the hazards of snake-oil type remedies. While this product may have no benefit, it probably has no direct harm either, but may have major indirect harms. Not only in individual patients who may not get benefit from other effective remedies, but also in a general sense by undermining the rational basis for medicine.
Competing interests: Former employee of the UK Medicines Control Agency (now MHRA). Member of Pharmacovigilance Working Party of the CHMP at the European medicines Agency |
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Alain Braillon, Public Health Amiens France
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Deborah Cohen stressed that the Medicines and Healthcare Products Regulatory Agency decision to grant a licence to a homeopathic preparation, Nelsons Arnicare Arnica 30c pillules, was based upon: a) that use is plausible on the basis of long standing use and experience; b) that no evidence showed that they cause harm.(1) In contrast, the French Medicine Agency (AFSSAPS) is concerned by the second point. Indeed, it issued an official warning after a mix-up in the labelling of two homeopathic preparations: “Vials labelled Ginkgo biloba mother tincture contain Equisetum arvense mother tincture and vice- versa... AFSSAPS has said that “Pharmacists will have to report this information to the doctors in their neighbourhood likely to have prescribed these products...and to the patients known to have used one of these two products between May and October, 2007.”(2,3) In the UK the vast majority of primary care trusts have cut funding for homeopathic preparations and the number of prescriptions for these remedies dropped from 83,000 in 2005 to 49,300 in 2007, despite an increase in the number of prescriptions for medical treatments overall. In contrast, in France homeopathic preparations are reimbursed under the mandatory National Health Service scheme despite a high price (eg. a homeopathic preparation of Ginkgo biloba costs 0.53€ a day, captopril for hypertension is only 0.33 €, diuretics are even cheaper) and no evidence shows that it works. The European Medicines Agency must act to ban crackpot medicines from Europe. 1 Cohen D. Drugs agency grants its first licence to homoeopathic product. BMJ 2009;338:b2055 2. Attention mes amis! Homeopathic emergency in France! http://dcscience.net/?p=196#more-196 (accessed May25, 2009) 3. http://www.afssaps.fr/Infos-de-securite/Communiques-depresse/ Retrait-de-lots-de-Gingko-biloba-et-Equisetum-arvense (no longer available) Competing interests: None declared |
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Peter J Flegg, Consultant Physician Blackpool FY3 8NR
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Alain Brellon has referred to the farcical situation of a French homeopathic preparation being recalled because it was incorrectly labelled. Heaven forbid that one remedy might have been mistaken for another, when neither of them actually contained anything (however one must assume their placebo action was unaffected). It is time people realised that quality control in terms of homeopathic production seems to consist entirely of checks on whether the labelling equipment is working correctly. Effective quality control concerning the constituents themselves is non-existent. This point was conceded by the Society of Homeopaths to the House of Lords Science and Technology Committee in 2007, when their spokesperson replied to the question of how it is possible to distinguish between homeopathic therapies with the immortal words: “Only by the label”. (1) For those who are sufficiently deluded to believe homeopathy works the issue of quality control should matter greatly, but has never been addressed. The rest of us can continue to chuckle at the idiocy of it all (if we didn’t laugh, we’d cry). (1) See Q538 http://www.publications.parliament.uk/pa/ld200607/ldselect/ldsctech/166/7022105.htm Competing interests: None declared |
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Dr Viera Scheibner, Scientist (Retired)/Author Blackheath NSW Australia
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The real tragedy for humanity is that people who have not studied homoeopathy and the evidence for its effectiveness pass judgment about it, not realising that they are just revealing their unforgivable ignorance. An American orthodox doctor, Dr Constantine Herring, set out to debunk homoeopathy; he did the right thing and studied it first, and became a famous homoeopath (Scheibner: Australian Doctor; 2 May 2003). One of his contributions was Herring’s law of the appearance of symptoms. For example, in normal measles, a rash appears first behind the ears, on the forehead and the trunk and moves to the extremities. When the immune system is deranged (such as in atypical measles occurring in measles- vaccinated children), the rash first appears on the extremities and moves to the trunk, resulting in pneumonia, encephalitis or meningitis, which resists all (orthodox) treatment and carries 12-15% mortality rate. Vaccinated children do not develop immunity to measles, they remain susceptible to it. American chiropractors were taken to court by the American Medical Association but were granted a permanent injunction against the AMA. Why? When asked by the judge what chiropractic was, the AMA’s representative did not know. Homoeopathy is a scientific system of pharmacological medicine. It operates on many levels, one of which is submolecular (the number of molecules per 12gm being below Avogadro’s number which means that there is not a single molecule in the remedy) and understands the dose effect of medication (this can also be described as paradoxical effect such as has been observed with stimulants). Another principle is that of similia similibus curentur, i.e. when a substance elicits certain symptoms when administered to a healthy person at a normal dose, it will cure a person with those symptoms when administered at a submolecular level. A classical example is a homoeopathic quinine remedy in malaria: when taken by a healthy person at a normal dose, quinine causes heart irregularities, spiking fevers and shivers – the signs observed in malaria. Hence when quinine is administered by homoeopathic dose to a malaria sufferer, it will cure him/her of malaria. It will actually support the body’s own defences and curative mechanisms to deal with malaria. It does nothing to the parasite which cannot develop resistance to the structure of quinine as it does to orthodox treatments. The reason for its effectiveness is that a homoeopathic remedy is an electromagnetic imprint of the structure of the substance on the “soluent” (which usually is 86% alcohol or pure spring water). Administered correctly, by a trained homoeopath and not a medical doctor dabbling into homoeopathy (no offence, folks), there are no deleterious effects, unlike with orthodox medications administered at what are euphemistically called “therapeutic” doses which, from the homoeopathic perspective, are highly toxic provings and not curative. Nature also operates on many levels, one of which is submolecular and hence homoeopathic. This effect is particularly obvious in the profound effect of even minute contaminants (coming from the US piggeries after they “cleaned-up their act”) on sea water. Homoeopathy also understands the individuality of response, hence its remedies are based on personality profiles. The remedy is derived from the assessment of the whole person and the symptoms expressed, not just a standard treatment for a disease, regardless of the individual nature of the person. Hence this “homoeopathic product” that has been licensed will have only limited effectiveness. However (proper) homoeopathy is the pharma medicine of the 21st century. How can anybody think that they can debunk it with their ignorance? Competing interests: None declared |
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Michael F Vagg, Pain Specialist Geelong 3220 Australia
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Homeopaths can argue until they are blue in the face that they can't be proved wrong about homeopathy, but whatever RCTs may show, they don't take into account that the essential and fundamental principles of homeopathy cannot be correct in the universe in which we live. They are incompatible with known and well-verified scientific facts in physics, chemistry and biology. Scientists are only too happy to look at new research, and are open to new evidence which overturns existing hypotheses, but the onus is on homeopaths to produce better evidence than they have to date AND to demonstrate how their special pleadings about implausible mechanisms of action can be reconciled with known facts about the natural world. until then I and others of a similar mind will continue to regard them as irritating and occasionally dangerous sideshow acts. Competing interests: None declared |
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David Colquhoun, Research Professor UCL WC1E 6BT
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The strap line for the MHRA is "We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe." Yet the MHRA has made mockery of its own aims by ignoring the bit about "ensuring that medicines . . . work" and allowing Arnica 30C pills to be labelled "a homoeopathic medicinal product used within the homoeopathic tradition for the symptomatic relief of sprains, muscular aches, and bruising or swelling after contusions." This label should be illegal anyway because the pills contain no trace whatsoever of the ingredient on the label, but this deceit has been allowed through a legal loophole for a long time now. If you sold ‘strawberry jam’ that contained not a trace of strawberry you'd be in trouble. But I can see no legal loophole that allows the manufacturers of Arnica 30C to evade the provisions of The Consumer Protection from Unfair Trading Regulations (May 2008). These regulations state that one of the 31 commercial practices which are in all circumstances considered unfair is "falsely claiming that a product is able to cure illnesses, dysfunction or malformations" The consumer protection laws apply to the way that "the average consumer" will interpret the label. The average consumer is unlikely to know that "used within the homoeopathic tradition" is a form of weasel words that actually means ‘there isn't a jot of evidence that the medicine works’. Since there is not the slightest evidence that Arnica 30C pills provide symptomatic relief of sprains etc., the labelling that the MHRA has approved appears to be illegal. The MHRA is not selling anything itself, so I presume that they won't find themselves in court, but anyone who follows their advice could well do so. Competing interests: None declared |
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Neville W Goodman, Retired Anaesthetist Bristol, BS9 3LW, UK
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Sadly, the immediately preceding response to Michael Vagg's, from Dr Scheibner, illustrates perfectly why it is pointless trying to use science to dismiss homeopathy. If the science don't fit, they simply alter the science until it does. If it ain't molecules, it must be sub-molecules: yes - quarks, strangeness and charm come in homeopathic bottles. Competing interests: None declared |
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Nicholas Moore, Clinical pharmacologist 33076 University of Bordeaux
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As a clinical pharmacologist, I fully support and applaud all who state that homeopathy has the same scientific value as the flat earth theory, intelligent design or the moon being made of cheese. Others believe in magical stones, in chiromancy, in astrology or voodoo, which are also right sometimes, by chance. Giving homeopathy credit for any kind of demonstrable efficacy is ludicrous and we all know it, after several hundred well-done clinical trials (see Ben Goldacre's Bad Science). Acupuncture and traditional chinese medicine are not far behind, though since acupuncture and TCM may actually harm the patient, there is a remote chance they may also do something (1). On the other hand, a good placebo is an incredibly useful (and powerful) therapeutic tool, that should only be used with caution (2). In this context, and when there is a need to give something more to a patient than just good words, a truly inactive placebo, with little risk of harm, might actually be useful, if only to avoid giving more dangerous but still useless drugs. The first indication the NHS should consider for homeopathy would be the common cold, probably acute sinusitis (if it doesn't get better within a week, then use antibiotics), insomnia (as effective as benzodiazepines after 2 weeks, and much less addictive), and any number of uselessly overtreated illnesses. It should be offered in a choice of colours appropriate to the indication,(3) the content being irrelevant, with clear indications that this will not alter the course of the disease, but the patient will feel better, which is also one of the aims of the medical art, if not its science. 1) Moore N. Assessing drug safety. Bmj 2005;330(7490):539-40. 2) Moore ND. Placebos in medicine: Pain that is relieved by placebo is not therefore unreal. Bmj 2005;330(7481):45. 3)Jacobs KW, Nordan FM. Classification of placebo drugs: effect of color. Percept Mot Skills. 1979 Oct;49(2):367-72. Competing interests: I am a trained pharmacologist, and reject vehemently the use in the same sentence of homeopathy and pharmacology |
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S Pervaiz, sessional gp Wolverhampton/ W Midlands
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The Homeopathy tradition seems to be about diluting things to such a level that people are baffled by the label on the bottle, whilst natural or placebo healing takes place. I am surpised that MHRA agrees with the idea of total dilution - even of the facts. Competing interests: No competing interests |
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