Memorandum submitted by Professor John C McLachlan HO 06

 

Response to the Consultation on Government policy on licensing of homeopathic products, Government policy on the funding of homeopathy through the NHS, and the evidence base on homeopathic products and services

I will consider the topics listed for consultation in reverse order, since the evidence base is paramount.

The evidence base on homeopathic products and services

1. Currently, regulated health professions are bound by the requirement for evidence based treatment. The GMC states[1] "In providing care you must provide effective treatments based on the best available evidence". The Code of the Nursing and Midwifery Council[2] states "You must deliver care based on the best available evidence or best practice". Even in government, one of the Essential Professional Skills for Government competencies is: "Analysis and use of evidence: Links evidence with specific outputs to challenge decision-making and identify ways to improve its quality and use". Evidence-based medicine and public health have radically improved health, and continue to do so. It is hard to understand why this requirement should be arbitrarily abandoned for alternative medicine practices. Yet despite the MHRA claiming that they 'ensure medicines work', they licence homoeopathic products for which there is no evidence of efficacy, and indeed, evidence that they do not work.

 

2. It is sometimes erroneously claimed that the rules of evidence do not apply to homoeopathic medicine. Indeed the MHRA state so explicitly : "Because of the philosophy of homoeopathy and the nature of the products, it is difficult to establish efficacy for homoeopathic products by way of clinical trials"[3]. This is quite untrue. The nature of homoeopathic products (frequently, pillules indistinguishable other than by the label) render them particularly well suited to randomised controlled trials: the argument that treatments are individualised is irrelevant, since a patient can be prescribed an individualised homoeopathic treatment, then entered into an allocation process by which they are randomised to either the homoeopathic or placebo arm. It is not philosophy or the nature of products which renders efficacy difficult to establish: it is lack of efficacy.

 

3. This line of argument by homoeopaths can be summarised as 'Evidence does not support homoeopathy - so let us attack the concept of evidence'. However, since homoeopathic advocates cite the outcomes of randomised trials when they believe they are favourable, and only denigrate them when they are not, this argument is used inconsistently. If the normal standard for statistical significance is set at p < 0.05, then some false positives are inevitable, even with inert substances. It is consistent performance which is important, and I do not know of any examples of consistent efficacy for homoeopathic remedies in double blind randomised controlled trials. NHS Evidence [4] on Complementary and Alternative Medicine, despite being led by a homoeopath practitioner, produces a paltry handful of debatable findings each year. Although meta-analyses showing no effects of homoeopathy have been criticised by homoeopaths[5], they then rather miss the observation that any effects which are present are too small to be meaningful.

 

4. Accepting homoeopathic beliefs about the consequences of dilution also requires acceptance that the basic rules of physics and chemistry are held in abeyance. If this were true, it would be a revolution in physics thinking comparable with that of relativity. Yet no serious physicist is interested in everlasting fame by exploring it - because none assess it as other than fatuous.

 

5. The MHRA may have been misled by the view that homoeopathic remedies must be harmless, since they contain no active ingredients. And indeed, homoeopathy is only dangerous if you believe in it. The dangers that arise if you truly believe are two fold.

 

6. Danger 1. Misdiagnosis by homoeopaths. It might be thought that homoeopathy merely operates as a placebo effect and for conditions which are chronic, difficult to diagnose or difficult to treat, and therefore does not pose potential harms. However, to tell which conditions are treatable by rational means requires training in evidence based methods, and misdiagnosis can be lethal.

7. Danger 2. Withdrawal from rational treatment. As private practitioners, homoeopaths have a vested interest in patients using their services. Alternative practitioners frequently attack rational evidence based medicine in a variety of ways, often tacitly, but sometimes explicitly. The natural outcome is for clients under their care to abandon evidence based methods for methods which do not require evidence. The consequences for this can be lethal, as in promoting homoeopathy for the treatment of HIV/AIDS[6]. Some case histories are adduced to support this.

 

8. Nine year old Nahkira Harris died of diabetes after she did not receive insulin treatment which would have preserved her life[7]. The prosecutor said that the parents ignored advice to return her to hospital and sought homeopathic remedies. The judge also criticised a GP, author of a book called "How to use homoeopathy effectively", who was later severely admonished by the General Medical Council. Nahkira's parents were convicted of manslaughter. Six months old Cameron Ayres 'died from a rare disorder after being denied conventional care by his parents who held strong beliefs in alternative medicine'[8]. The Telegraph headed the story "Homeopathy couple refused help for their dying baby'. Nine month old Gloria Thomas died from an eminently treatable condition (eczema) because her parents, adherents of homoeopathy, withdrew her from rational treatment[9]. 'Ms A' died after a doctor with homoeopathic beliefs asked Ms A, to follow only "homeopathic remedies". The GMC found the doctor guilty of professional misconduct[10].

 

9. The MHRA have lent credibility to homoeopathic remedies, increasing the risks of such outcomes. As a leading homoeopathic manufacturer commented "The fact that therapeutic indications may now be included on the packaging of licensed homoeopathic medicines not only opens the practice of homoeopathy up to new users but also gives it added credibility....[11] "

 

10. Further examples of risks posed by validation of homeopathic remedies by government are that homeopaths may advise travellers that their remedies act prophylactically against malaria[12] or advising patients not to get vaccinated [13].

11. The MHRA has indicated that they are prepared to accept 'homoeopathic provings' as evidence. What does this mean? An article called "Trituration Proving of the Light of Saturn" by Patricia Maher was recently published in the e-journal "Interhomeopathy[14]'. It says "The remedy was made by exposing powdered milk sugar to a powerful telescope in Boston, Massachusetts while it was focused on the planet Saturn during April 2009". After exposure to the remedy, seven 'provers' (two of whom knew what the 'remedy was) recorded their conversations. There was a long conversation in which provers named their 5 favourite Beatle songs. From the start, conversation was filled with erotic double‐entendres ("How's my technique?" ). One prover demonstrated a seductive way of eating a sandwich: "if I could get food that way I would never be hungry....I want to draw you naked..." Now, given that there were 4 females and 3 males present, mild flirtation does not seem so surprising. Nonetheless, some physical symptoms were recorded. "The female provers especially experienced a great deal of itchiness: Head, nose, eyes itchy. Head itchy. Back itchy, breasts itchy, thighs. Desire to yawn and stretch". Yet clear therapeutic conclusions could be drawn. "From a homeopathic point of view, both the physical symptoms that appeared and the content of the discussion during the proving suggest that this remedy might be effective for accidentrelated trauma, bone and nerve damage. This remedy may also be effective for allergies, in light of all the itching that occurred". These quotations are of course selected: read the entire article lest you think I am parodying it. Of course, Venus does not emit light but merely reflects sunlight, and so this proving is as rational as astrology. Other provings (presumably acceptable to the MHRA) have been conducted for cobwebs [15], Barn owl feathers [16], AIDS infected blood [17], and mobile phone radiation [18].

 

Government policy on the funding of homeopathy through the NHS

 

12. It follows from the foregoing that Government should not fund treatments which have zero efficacy, and pose hazards of misdiagnosis and withdrawal from treatment. Particularly regrettable is the attempt to hijack the term 'integrative' to conceal the nature of alternative treatments. The positive aspects of integrative medicine are already a key part of the curricula of modern medical schools, and are a routine part of the armoury of good doctors and health care practitioners.

13. It might be argued that the placebo effect of homoeopathy is sufficiently valuable to be worth paying for. However there is a profound dilemma relating to this use of NHS funds. If the practitioner believes that homoeopathy is a placebo, then prescribing it requires her/him to lie to the patient, and this runs contrary to ethical practice in health care. If the practitioner believes that homoeopathy works as advertised, then they are a danger to the patient as the case histories above (frequently involving qualified medical personnel) demonstrate. Further, whether or not the practitioner believes in homoeopathy, the patient who is being misled might reasonably choose to believe in it, since it was endorsed by the NHS, and subsequently choose to take advice on vaccination from a homoeopath, for instance.

 

Government Policy on the Regulation of Homoeopathic Products

14. Policy should be based on evidence of efficacy as required for other products making medicinal claims. It is particularly regrettable that the MHRA should think it has a role in promoting this particular industry[19]. The MHRA stated "Although the development of national rules by Member States under the 2001 Directive is optional, failing to introduce the scheme would inhibit the expansion of the homeopathic industry". This solicitude is not extended to any other industry.

15. Arguments might be made to the effect that more research needs to be done. However, the US National Centre for Complementary and Alternative Medicine has spent $2.5 billion dollars on alternative medicine research, and achieved no significant benefits[20].

 

 

Conflicts of interest

16. The author is John McLachlan, Professor of Medical Education and Associate Dean of Medicine at the University of Durham, although he writes here in a private capacity. He does not earn money from pharmaceutical industries, provision of health care, homoeopathic practice, or sale of homoeopathic products.

 

November 2009



[1]GMC Good Medical Practice - Delivering Good Clinical Care. Para 3. In GMC documents "must" means that it is obligatory, as opposed to "should". http://www.gmc-uk.org/guidance/good_medical_practice/index.asp

[2] http://www.nmc-uk.org/aArticle.aspx?ArticleID=3056

[3] Explanatory memorandum to the medicines for human use (national rules for homoeopathic products) regulations 2006

[4] http://www.library.nhs.uk/CAM/ViewResource.aspx?resID=317091

[5] http://hawk-handsaw.blogspot.com/2007/11/whats-wrong-with-shang-et-al.html

[6] http://www.dynamis.edu/new/HomeoforAIDS4UKrevlores.pdf

[7] Daily Telegraph Nov 6th 1993

[8] Daily Telegraph 5th April 2000

[9] http://www.smh.com.au/national/parents-guilty-of-manslaughter-over-daughters-eczema-death-20090605-bxvx.html

[10] http://news.bbc.co.uk/1/hi/england/london/6255356.stm

[11] Robert Wilson, chairman of Nelsons, quoted BMJ 2009;338:b2055

[12] http://news.bbc.co.uk/1/hi/programmes/newsnight/5178122.stm

 

[13] Ernst E. Rise in popularity of complementary and alternative medicine: reasons and consequences for vaccination. Vaccine 2002; 20: S90-S93

[14] http://www.interhomeopathy.org/index.php/journal/entry/trituration_proving_of_the_light_of_saturn/

[15] http://www.homoeopathy.co.uk/resources.htm

[16] http://www.welshschoolofhomoeopathy.org.uk/proovings.htm

[17] http://www.hominf.org/aids/aidsfr.htm

[18] http://www.littlemiracle.freeuk.com/#Proving%20of%20Mobile%20Phone%20Radiation

[19] MHRA Memorandum, 2006

[20] http://abcnews.go.com/Business/wireStory?id=7804031