Despite
royal support, homeopathy is having a bad press, writes Dr Neville Goodman.
Back in 2005, the Lancet challenged the Department of Health after a systematic
review of placebo-controlled trials [1] found the effects of homeopathy were
no more than placebo. Then in 2006, a group of academics wrote a letter to primary
care trusts (PCTs) asking them to review their funding of alternative medicine
[2]. Now the campaign is gathering speed.The academics have written again. Concentrating this time on homeopathy, Professor Gustav Born of the William Harvey Institute, and a group of similarly learned colleagues, wrote, “a number of trusts have reduced their provision of homeopathic services through commissioning arrangements to reflect the need for greater scientific scrutiny”, and invited them to review their own trust’s positions [3]. Many of the newspapers picked up on the story. Professor Michael Baum’s well argued critical article in the Daily Mail [4] was a welcome change from that newspaper’s usual slant on the medical fringe.
Another of the signatories, Professor Ray Tallis (who has, incidentally, agreed to accept this year’s HealthWatch award), featured in a discussion on the BBC Radio 4 Today programme [5] with Dr Peter Fisher. Dr Fisher is the clinical director of the Royal London Homeopathic Hospital, and has been very busy recently defending homeopathy, but I find these “discussions” unsatisfactory. The only way properly to lay out evidence is dispassionately and logically, with proper citation and interpretation. Of course, some evidence - in any walk of life - can be interpreted in more than one way, but it is just too easy for radio discussions to descend into, “Yes it is”; “No it isn’t.”
Published “debates” are often little better. Hospital Doctor’s recent debate [6], “Should homeopathy hospital survive?” - was between Dr Fisher (arguing “yes”) and Professor Baum (“no”), but I suspect they were given their briefs in isolation. Dr Fisher mentions homeopathy just once, to say it is only one of a wide range of therapies, whereas Professor Baum focuses on it, so the two sides of the debate talk of different things. However, Dr Fisher appears somewhat ill-informed when he writes of the therapies they offer that, “all are supported by some evidence”. Homeopathy is supported only by selective evidence. Dr Fisher also uses the common ploy of finding reasons why alternative therapies are at a disadvantage. He admits that the level of evidence is not as high as for conventional therapies, but implies that this is only because, “treatments are rarely patentable, and so not of interest to ‘big pharma’”. He writes, “observational outcome studies show clinical improvement and reduction of medication across a wide range of conditions”, but what sort of evidence is that? He cites no references; Professor Baum does.
The Guardian’s take on the academics’ letter provoked correspondence[7]
from Andrew Kirk, who is the Chairman of the Society of Homeopaths. In it, all
the old arguments emerge. “Substantial savings could be made by introducing
homeopathy into general practice” true: because too many drugs are prescribed
when they are not needed. “The NHS spends £466m a year treating
adverse effects from medicines” while, “Homeopathy’s track
record for safety is excellent”: true - but unsurprising seeing as it
contains no active substance. And is it entirely safe? What of the homeopaths
who advocate homeopathy for malarial prophylaxis? The recipients won’t
suffer side-effects from the homeopathic preparation but they may well contract
malaria.
Andrew Kirk then says that “describing homeopathy as ‘unsupported
by evidence’…turns a blind eye to the excellent outcomes from homeopathic
treatment”. This “evidence” is an outcome study of 6500 patients,
70% of whom “reported an improvement to their health following homeopathy”,
and for many of these patients, “conventional medicines had failed to
help”.
I don’t need to explain to readers of this newsletter why this is not very good evidence, but nor do I need to explain how it will be taken, by those who wish to do so, as the perfect counter to anything Ray Tallis or Michael Baum might choose to say. Which is why I would never wish to find myself in a studio with Dr Fisher.
One thing, though, is undeniable. Homeopathic medicines are extremely cheap. In The Times [8], they explained that, with its limited resources, the NHS should only cover treatments properly shown to be effective. Much though I would like to see homeopathy consigned to the medical history books as an interesting hypothesis of its time that died from lack of evidence, I’m afraid it will take the funding of a large number of homeopathic preparations to cover the cost of the expensive new cancer drug that the Times chose to feature. In my view, the savings from not allowing homeopathy on the NHS is a secondary consideration to the main one: there is no place for treatment based on nonsense.
Michael Baum was not completely negative, though. He asked that the Royal London Homeopathic Hospital be rebranded as a centre for supportive and palliative care, offering complementary therapies that do work, such as psychological counselling, group therapy, therapeutic massage, and music and art therapy. There is a challenge for the medical homeopaths: forget Hahnemann’s outdated notions of infinite dilutions, and concentrate on what they do best, which is achieving rapport with the patients and making them feel better and more able to deal with their problems.
Neville Goodman
Consultant Anaesthetist, Southmeads Hospital, Bristol
References
“Insulin
Murders - True Life Crimes” is written by Professor Vincent Marks, critically
acclaimed author of Panic Nation and a world authority on insulin, together
with Caroline Richmond, a leading medical journalist. Richmond remains an active
member of the HealthWatch Committee, with an article in this issue (page 6),
while Marks has only recently retired.
Their book, published by the Royal Society of Medicine, details legal cases over the last 50 years, and offers exclusive access to the medical aspects of the Von Bulow case, the first court case to be broadcast in its entirety on US television, as well as featuring other real life crime cases from the UK to New Zealand. See below for ordering details and a full review of this fascinating new book.
On page 22 we are told that, “the American Medical Association recommends that all adults take a multivitamin supplement”. In an article by Sarah Brewer earlier in the magazine [1] we are told a subtly different story; the conclusion of a review of 150 clinical trials was that “pending strong evidence from randomised trials, it appears prudent for all adults to take vitamin supplements”.
In fact, the reference cited was not to the scientific review [2], but to a
three page paper discussing the clinical applications of the literature review
[3]…
David A Bender
Department of Biochemistry and Molecular Biology
University College London
References
GERONTOLOGIST,
philosopher and prolific author Professor Raymond Tallis will be the speaker
and award-winner at HealthWatch’s nineteenth AGM and Open Meeting this
October. The meeting, which is free and open to all, will take place on Thursday
18th October 2007 at The Medical Society of London at 11 Chandos Street, W1G
9EB.
THE COMPULSIVELY readable Improbable Science website run by Professor David Colquhoun, the distinguished University College London pharmacologist, was moved recently to http://www.dcscience.net/quack.htmlfollowing a complaint from a herbalist, but we have just learned that it will shortly be restored back to its original home at the UCL server.
Another website that will fascinate anyone interested in the follies of some alternative psychological approaches to health is run by the Association of Skeptical Enquiry, whose chairman is Chartered Clinical Forensic Psychologist Dr Michael Heap. In-depth and well-written articles, packed with enthralling and bizarre case histories, explore issues such as psychic healing and hypnosis. See http://www.aske.org.uk/
New and updated position papers are being prepared by HealthWatch experts on a number of subjects and are a useful reference source. Along with Les Rose’s paper on homeopathy which appears above new papers are expected shortly on subjects including cancer. See http://www.healthwatch-uk.org/position.html
John
Garrow uses a fictional scenario to subject an “expert’s”
claim to scientific scrutiny…WHO is in a situation similar to that of the fictional Prof Klaames: there is a need to provide effective remedies in regions (such as western Nepal) where remedies of proven efficacy are too expensive to provide, so placebos (such as homeopathy) must be considered. When the WHO report is published in full detail it will be possible to compare it with Dr Fisher’s account, and apply the critical tests to see if the conclusions are biased in the manner discussed above. I hope by the time the next issue of the HealthWatch Newsletter is published The Editor will find space for a brief account of what the WHO thinks about the efficacy of homeopathy.
Meanwhile, there are several other public statements that deserve close scrutiny about the proven efficacy of treatments, to answer the question “CIBeT?”. But I promise that in future CIBeT reviews I will never again lead you astray with fictional scenarios.
John Garrow
Emeritus Professor of Human Nutrition, University of London
The new regulations stem from a desire to resolve this obviously anomalous situation, driven by a European Directive. The Medicines and Healthcare products Regulatory Agency (MHRA), issued a consultation on its proposals in February 2005. Four options were offered. Essentially these were
The MHRA states that the consultation responses were in favour of the last option, and this is now embodied in Statutory Instrument 2006 number 1952. The new regulations were laid before Parliament four days before the summer recess, and came into force on 1st September 2006, over five weeks before the new session, giving no opportunity for debate. Interestingly, the MHRA says that there were no strong public health reasons for taking any action, and that the only reason for rejecting the first option was the expectation of agitation by the homeopathy companies.
Although one purpose of the regulations might have been to encourage manufacturers to transfer efficacy claims from serious conditions to minor conditions only, a by-product is to allow such claims without the need to provide any supporting evidence. Instead, the MHRA will accept what it calls “non-scientific data” - its own words. In its explanatory notes, the MHRA admits that homeopathic products “have difficulty in demonstrating efficacy in clinical trials”. This is no different from saying “they do not work”. Data now acceptable can come from homeopathic “provings”. It cannot be over emphasised that “provings” have nothing at all to do with efficacy, and are carried out by giving healthy people undiluted homeopathic stocks. These may be of plant, animal, or mineral origin. The symptoms elicited by this process are imagined to indicate the diseases which the ultra-dilute finished product is able to treat, on the principle of “like cures like”. This, the so-called “law of similars”, is not supported by any scientific evidence. Indeed, since the new regulations appeared, a meta-analysis has appeared which shows that there is no consistency or reliability for studies of provings published from 1945 to 1994 [2]. Thus the already scientifically invalid basis for the MHRA’s proposals is also invalidated by the homeopaths themselves. The other main principle of homeopathy is the “law of infinitesimals”, the idea that medicines become more potent the more they are diluted. There is of course no evidence to support this either, and it is in conflict with all that we know about pharmacology, therapeutics, and indeed physics and chemistry themselves.
In addition, the new regulations accept as evidence, proof that the product has been used for the claimed indication “within the homeopathic tradition”. Obviously neither this requirement, nor “provings”, is anywhere near a definitive test of efficacy. The regulations do not list any other types of evidence as acceptable. Potential sources of data were listed as including homeopathic pharmacopoeiae and materiae medicae, and bibliographies, such that they would be accepted by homeopathic practitioners. In other words, all that is necessary is to convince homeopaths, and it is not necessary to win over anyone with a more scientific view of medicine.
The MHRA prefaced its consultation by stating quite clearly that clinical trial evidence was lacking. Interestingly, not one of the various homeopathy organisations which responded enthusiastically to the consultation even suggested that such a view might not be correct, despite vociferous claims from many homeopaths that clinical trials do show efficacy. It is not too difficult to find such positive trials if one ignores the matter of methodological quality. This might explain why, despite two centuries of use, the clinical evidence for homeopathy actually gets weaker over time [3]. The key question which any scientist, and the MHRA in particular, should ask is: “After 200 years why are we still arguing about the efficacy of homeopathy?”.
The MHRA published a summary of responses to the consultation [4], but omitted to mention that three medical Royal Colleges strongly criticised homeopathy. The Royal College of Physicians stated that, “it is important that unsubstantiated or false claims of efficacy are absolutely prohibited”. The other critical Royal Colleges were those of General Practitioners, and of Physicians (Edinburgh). Certain other groups, such as the National Eczema Society, voiced very similar objections. However the Royal College of Radiologists very warmly supported option (4), while all along mistaking homeopathy for herbal medicine. The Royal College of Nursing was even more enthusiastic, but the response was written by a homeopath. Several other organisations issued critical statements, including the Royal Society, The Academy of Medical Sciences, the Biosciences Federation, the Medical Research Council, and the Royal Society. The British Pharmacological Society (of which the MHRA’s chief executive and chairman are both members) said:
“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 1st September (Statutory Instrument 2006 1952), will regard non-scientific data as evidence of efficacy.”
By now, readers may be wondering what is driving such a bizarre move. The answer might be found in the MHRA’s own Regulatory Impact Assessment [5]. It is stated there that not to act thus would “inhibit the expansion of the homeopathic industry”. This is the first time that the MHRA has admitted to a commercial remit. It is not in its mission statement, but this is:
“We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.”
Les Rose BSc CBiol MIBiol FICR MAPM
HealthWatch committee member
Acknowledgement: Adapted with the publication’s permission from Rose, L British health care regulation moves away from science. Biologist 2007; 54 (1): 3-5.
References
As a regular reader of detective stories I was delighted to review this “true life” book of fourteen short stories taken from Professor Vincent Marks’ fascinating personal casebook. Professor Marks is a renowned world expert on clinical biochemistry with a special interest in nutrition, diabetes and the effects of insulin.
He is also a long-standing and active member of HealthWatch who invited Caroline Richmond, a well-known medical journalist and a fellow founder member of HealthWatch to collaborate with him in the presentation of some of his most challenging and high profile cases…
Diana Brahams
Barrister and HealthWatch Committee Member
Insulin Murders: true life cases is published by the Royal Society of Medicine Press. It is available from good booksellers or can be ordered online direct from http://www.rsmpress.co.uk
There was little or no Internet material in those days. I rapidly found a book called Everyone’s Guide to Cancer Therapy by Dollinger and others, then in its first edition. It is now in its fourth, and is excellent.
One of the first things I read was that my type of lymphoma is incurable, and I can recall the thonk as my heart hit my shoes…
Caroline Richmond
Medical Journalist and HealthWatch Committee Member
If a treatment helps people to feel better, then is it not reasonable to use it? Whilst alternative therapies may not be able to provide rigorous scientific evidence to support their use, surely the fact that so many report feeling better on them is a sufficient reason to justify their use. So what, if they are merely working by a placebo effect? HealthWatch is about effective treatments, and alternative therapies are often effective placebos - what is wrong with that?
This type of argument is very common not just with lay people, but with clinical doctors. It is indeed difficult to argue against. If one replies that the claims for efficacy are simply not true, the argument is, “Well so what, if it makes them feel better?”. Why deny people this help at least? Orthodox scientific methods could be cast as cold and uncaring in comparison to the holistic benefits of alternative medicine. When orthodox medicine no longer has anything to offer, why not use alternative medicines or complementary medicines as they are now called? The placebo effect, at its worst becomes some sort of “noble lie”, a way of comforting people regardless of whether there is any demonstrable medical benefit, partly through an irrational faith that there will be benefit.
There is a problem with this argument, and it is a profound problem…
James May
Lambeth Walk Group Practice
Kennington, London
The
saying attributed to Hippocrates, “Let your food be your medicine and
your only medicine be your food” is frequently invoked by nutritional
therapists to justify unproven and untested supplements and diets. Nevertheless,
there is convincing evidence from many epidemiological studies and randomized
controlled trials that in the area of chronic non-communicable diseases such
as cancer, hypertension and atherosclerosis, diet is indeed an important factor,
and relatively modest changes in diet may be beneficial…
David A Bender
Department of Biochemistry and Molecular Biology
University College London