Memorandum submitted by Professor John
C McLachlan (HO 06)
Response to the Consultation on Government policy
on licensing of homoeopathic products, Government policy on the
funding of homoeopathy through the NHS, and the evidence base
on homoeopathic products and services.
I will consider the topics listed for consultation
in reverse order, since the evidence base is paramount.
THE EVIDENCE
BASE ON
HOMOEOPATHIC PRODUCTS
AND SERVICES
1. Currently, regulated health professions
are bound by the requirement for evidence based treatment. The
GMC states[3]
"In providing care you must provide effective treatments
based on the best available evidence". The Code of the
Nursing and Midwifery Council[4]
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 license 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".[5]
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 homoeopathyso
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[6]
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,[7]
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 itbecause 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.[8]
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.[9]
The prosecutor said that the parents ignored advice to return
her to hospital and sought homoeopathic 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".[10]
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.[11]
"Ms A" died after a doctor with homoeopathic beliefs
asked Ms A, to follow only "homoeopathic remedies".
The GMC found the doctor guilty of professional misconduct.[12]
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"[13]
10. Further examples of risks posed by validation
of homoeopathic remedies by government are that homoeopaths may
advise travellers that their remedies act prophylactically against
malaria[14]
or advising patients not to get vaccinated.[15]
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".[16]
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 five
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 four females and three 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 homoeopathic 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 accident-related
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,[17]
barn owl feathers,[18]
AIDS infected blood,[19]
and mobile phone radiation.[20]
GOVERNMENT POLICY
ON THE
FUNDING OF
HOMOEOPATHY 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.[21]
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 homoeopathic 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.[22]
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
3 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 Back
4
http://www.nmc-uk.org/aArticle.aspx?ArticleID=3056 Back
5
Explanatory memorandum to the medicines for human use (national
rules for homoeopathic products) regulations 2006. Back
6
http://www.library.nhs.uk/CAM/ViewResource.aspx?resID=317091 Back
7
http://hawk-handsaw.blogspot.com/2007/11/whats-wrong-with-shang-et-al.html Back
8
http://www.dynamis.edu/new/HomeoforAIDS4UKrevlores.pdf Back
9
Daily Telegraph 6 November 1993. Back
10
Daily Telegraph 5 April 2000. Back
11
http://www.smh.com.au/national/parents-guilty-of-manslaughter-over-daughters-eczema-death-20090605-bxvx.html Back
12
http://news.bbc.co.uk/1/hi/england/london/6255356.stm Back
13
Robert Wilson, chairman of Nelsons, quoted BMJ 2009;338:b2055 Back
14
http://news.bbc.co.uk/1/hi/programmes/newsnight/5178122.stm Back
15
Ernst E. Rise in popularity of complementary and alternative medicine:
reasons and consequences for vaccination. Vaccine 2002; 20: S90-S93. Back
16
http://www.interhomeopathy.org/index.php/journal/entry/trituration_proving_of_the_light_of_saturn/ Back
17
http://www.homoeopathy.co.uk/resources.htm Back
18
http://www.welshschoolofhomoeopathy.org.uk/proovings.htm Back
19
http://www.hominf.org/aids/aidsfr.htm Back
20
http://www.littlemiracle.freeuk.com/£Proving%20of%20Mobile%20Phone%20Radiation Back
21
MHRA Memorandum, 2006. Back
22
http://abcnews.go.com/Business/wireStory?id=7804031 Back
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