Memorandum submitted by Royal Pharmaceutical
Society of Great Britain (HO 37)
PREAMBLE
The Royal Pharmaceutical Society of Great Britain
(RPSGB) is the professional body for pharmacists and the regulatory
body for pharmacists and pharmacy technicians in England, Scotland
and Wales. The primary objectives of the Society are to lead,
regulate, develop and represent the profession of pharmacy.
The RPSGB leads and supports the development
of the profession within the context of the public benefit. This
includes the advancement of science, practice, education and knowledge
in pharmacy. In addition, it promotes the profession's policies
and views to a range of external stakeholders in a number of different
forums.
Following the publication in 2007 of the
Government White Paper Trust, Assurance and Safety—The
Regulation of Health Professionals in the 21st Century, the
Society is working towards the demerger of its regulatory and
professional roles. This will see the establishment of a new General
Pharmaceutical Council and a new professional body for pharmacy
in 2010.
The Society welcomes the opportunity to respond
to the invitation of the House of Commons Science and Technology
Committee to submit evidence to their enquiry on homeopathy. In
this document the Royal Pharmaceutical Society has provided responses
to the three issues highlighted by the Committee.
SUMMARY OF
RECOMMENDATIONS
Recommendation 1: research needs to be
undertaken to develop alternative and robust methodology to assess
clinical interventions involving homeopathic treatments.
Recommendation 2: unless or until such
a time as efficacy of a homeopathic product can be proven using
appropriate methodology (as for conventional medicines) claims
of efficacy should be removed from the label of a homeopathic
product. This recommendation includes any homeopathic products
with PLR when they come up for review by the MHRA in the near
future.
Recommendation 3: Unless or until such
a time as efficacy of a homeopathic product can be proven using
appropriate methodology (as for conventional medicines) labelling
on the homeopathic product should make it very clear that the
efficacy of the homeopathic preparation has not be proven.
Recommendation 4: Patients are made aware
of the fact that there is no scientific basis for the use of homeopathy.
Recommendation 5: research should urgently
be undertaken to determine how effective homeopathic remedies
are and whether it is the whole package of care provided by homeopathic
treatment that is beneficial for the patient rather than the product
per se.
Recommendation 6: homeopathic remedies
should be reviewed by NICE if they are to be used within the NHS
to ensure that they give value for money and to ensure that the
funding of conventional medicines is not compromised by their
use.
Recommendation 7: the cost-benefit ratio
for homeopathic interventions should be established.
Recommendation 8: if homeopathy continues
to be made available on the NHS all homeopaths must be
registered with an appropriate body and governed by a Code of
Ethics.
RESPONSE
1. Government policy on licensing homeopathic
products
1.01 Between 1971 and 2006 it
was not possible to make a claim about effectiveness of a new
homeopathic product, product registration was made solely on the
basis of quality and safety.
1.02 The introduction of UK National Rules
in September 2006 (as permissible under European legislation)
allowed limited medical claims such as "for the relief of…."
for new homeopathic preparations provided there is "suitable
evidence that the product has been used as a homeopathic treatment
in the indications sought. Information provided should be in the
form of provings, excerpts from homeopathic material medica or
other bibliographic data and should be sufficient to demonstrate
that homeopathic practitioners would accept the efficacy of the
products for those indications".
1.03 It should be noted that products registered
under the UK National Rules are intended for over-the-counter
sale and are indicated for the relief of self-limiting minor symptoms
and minor conditions. For these purposes, minor symptoms are defined
by the MHRA as those, which can ordinarily and with reasonable
safety, be relieved or treated without the supervision or intervention
of a doctor. Serious conditions such as diabetes, epilepsy, cancer
and prevention and treatment of malaria are excluded from the
scheme.
1.04 Significantly the UK National Rules
go against the findings of the 2000 UK Parliamentary Select
Committee on Science and Technology on complementary and alternative
medicine in reported that "any therapy that makes specific
claims for being able to treat specific conditions should have
evidence of being able to do this above and beyond the placebo
effect".
1.05 One consequence of the 2006 UK
National Rules is that there is no requirement for rigorous clinical
data to demonstrate efficacy of a new homeopathic medicine as
is understood in the context of conventional pharmaceutical medicines
where clinical efficacy is demonstrated using pre-clinical tests
and clinical trials.
1.06 Homeopathic provings (ie where healthy
volunteers are given the potential homeopathic substance to elicit
the same symptoms as the illness that is to be treated) can now
be used as evidence for medical claims despite the fact that they
do not prove efficacy. Furthermore the homeopathic literature
can also be used as evidence for medical claims despite the fact
that it may not have been subjected to the same level peer review
as more main stream scientific literature. The reliance on such
evidence for homeopathic preparations is in stark contrast to
the stringent tests that conventional medicines must undergo prior
to obtaining a licence.
1.07 When the UK joined the European Community
in 1973, a review of all products covered by Product Licences
of Right (PLR) awarded under the 1968 Medicines Act became
mandatory. Many homeopathic products had been awarded Product
Licences of Right (PLR) and were able to claim efficacy if the
product had been previously used for this purpose. However, it
was recognised by the regulatory authorities that providing proof
of efficacy for homeopathic products would pose a difficulty,
and as a consequence homeopathic medicines were exempted from
the review and many PLRs remain in place. The MHRA has however
stated that it will review all PLR by 2013 and remove "any
unsuitable indications", although under current UK National
Rules it is unlikely that many homeopathic preparations will not
be granted licences.
1.08 The RPSGB is concerned that, under
the current UK National Rules, the patient will not realise that
the regulatory regime for homeopathic products is not the same
as that for conventional pharmaceutical medicines and may understand
the phrase "for the relief of or treatment of….."
on the label to imply an endorsement of efficacy (by the MHRA)
where none has actually been proven. Indeed while it is acknowledged
that homeopathic manufacturers are advised under National Rules
to include a statement on all labels and product literature along
the lines that "A homeopathic medicinal product used within
the homeopathic tradition for the relief of or treatment of …."
and a statement advising the consumer to consult a medical practitioner
if symptoms persist, our concern is that this is not a clear enough
message to the patient.
1.09 The RPSGB believes that any medicinal
claim for a product must be based on sound scientific and clinical
evidence and that it is the duty of the regulatory authorities
to ensure that no claims for efficacy for any form of a medicine
(homeopathic or otherwise) are made unless there is good scientific
and clinical evidence for doing so.
1.10 It has long been claimed by the homeopathic
community that current randomised controlled clinical trial methodology
is inappropriate for assessing any benefit arising from a homeopathic
intervention (Weatherley et al Homeopathy (2004) 93, 186-189;
Chanda and Furnham Focus on Alternative and Complementary Therapies
(2008) 13, 157-167).
Recommendation 1: research needs to be
undertaken to develop alternative and robust methodology to assess
clinical interventions involving homeopathic treatments
Recommendation 2: unless or until such
a time as efficacy of a homeopathic product can be proven using
appropriate methodology (as for conventional medicines) claims
of efficacy should be removed from the label of a homeopathic
product. This recommendation includes any homeopathic products
with PLR when they come up for review by the MHRA in the near
future
Recommendation 3: Unless or until such
a time as efficacy of a homeopathic product can be proven using
appropriate methodology (as for conventional medicines) labelling
on the homeopathic product should make it very clear that the
efficacy of the homeopathic preparation has not be proven
1.11 The RPSGB recognises the UK Government
view that consumers should be free to make informed choices that
involve non-conventional approaches to the relief of certain symptoms
or conditions. It is essential therefore that the patient is given
the appropriate information to make these informed choices and
as a consequence it should be clear to the patient that there
is no scientific evidence for homeopathy (contrary to what is
sometimes stated on homeopathic web-sites) and that the claims
of efficacy made for homeopathic medicines (on their labels) are
not made on the same stringent basis as conventional medicines.
1.12 The RPSGB is concerned that the current
Government policy of allowing indications for homeopathic preparations
intended for over the counter sale, may be seen to legitimising
the practice of homeopathy and may prompt some patients to use,
for example, homeopathic preparations for malaria prophylaxis,
treatment of HIV, TB, influenza, childhood diarrhoea or in place
of immunisation, practices which have been condemned earlier this
year by the WHO (British Medical Journal (2009) 339, 479).
Recommendation 4: Patients are made aware
of the fact that there is no scientific basis for the use of homeopathy
2. Government policy on funding homeopathy
through the NHS
2.01 The NHS currently supports 4 homeopathic
hospitals in Bristol, London, Liverpool and Glasgow. Until March
2009 NHS patients could be referred to the homeopathic hospital
in Tunbridge Wells. It is reported that the four NHS homeopathic
hospitals currently treat 55,000 patients per year referred
by GPs, PCTs and NHS specialists. In addition there are over 400 GP's
practising homeopathy and who are regulated by the GMC and are
members of the Faculty of Homeopathy. They treat 200,000 NHS
patients a year with homeopathy. GPs are able to refer NHS patients
to qualified and regulated homeopaths. However, it is not clear
what the cost of homeopathy currently is to the NHS.
2.02 Although there is no scientific or
definitive clinical trial evidence for the benefit of homeopathy,
there is anecdotal evidence of patients gaining benefit from such
treatment. For example an analysis of 23,000 out-patient
consultations at the Bristol Homeopathic Hospital from 1997 to
2003, suggested that over 70% of patients followed up reported
positive health changes following homeopathic treatment (Spence
et al Journal of Alternative and Complementary Medicine (2005)
11, 793-798). Furthermore there are instances after treatment
using homeopathy that for some illnesses patients no longer required
conventional treatment. For example the London homeopathic hospital
report that "specific projects on childhood asthma and eczema
showed a decrease in the use of steroid inhalers as well as the
use of topical steroids in 60% of the children" (London
Homeopathic Hospital web-site, http://www.uclh.nhs.uk/GPs+ healthcare+professionals/Clinical+services/Homeopathy+%28Royal+London+Homoeopathic+
Hospital%29/Homeopathy+-+Childrens+Clinic/accessed 9 November
2009).
2.03 Homeopathy involves a holistic approach
to the treatment of patients, which requires an assessment of
the physical, mental and emotional state of the patient as well
as the symptoms they present with. Whether the benefits patients
gain when taking homepathic preparations is due to a counselling
effect ie someone just giving the time to listen to a patients
problems and talk them through as many experts believe (a typical
initial homeopathic consultations takes about 45-60 minutes,
follow up ones slightly less), a psychological effect due to the
belief by the patient they will get better, or the actual homeopathic
remedy itself, is not clear.
2.04 It must be also realised that homeopathic
treatment on the NHS rarely means solely homeopathic remedies
as it usually used in conjunction with conventional medicine and
sometimes other complimentary medicines. Indeed homeopaths frequently
state that homeopathy should not be used instead of conventional
medical treatment, but that it should be used in conjunction with
it.
Recommendation 5: research should urgently
be undertaken to determine how effective homeopathic remedies
are and whether it is the whole package of care provided by homeopathic
treatment that is beneficial for the patient rather than the product
per se
Recommendation 6: homeopathic remedies
should be reviewed by NICE if they are to be used within the NHS
to ensure that they give value for money and to ensure that the
funding of conventional medicines is not compromised by their
use
Recommendation 7: the cost-benefit ratio
for homeopathic interventions should be established
Recommendation 8: if homeopathy continues
to be made available on the NHS all homeopaths must be
registered with an appropriate body and governed by a Code of
Ethics
3. The evidence on homeopathic products and
services
3.01 Homeopathy has been used in Britain
for about 150 years, and has always been available through
the NHS since its inception in 1948 although it has gained
increasing prominence with the general public over the last 20
years, mainly because it is generally viewed as being safe (being
prepared from plant, mineral or animal), not producing serious
adverse reactions (other than aggravations, ie an initial worsening
of symptoms following administration of the homeopathic remedy,
or in individuals who have a lactose sensitivity when lactose
is used as diluent), and not interacting with conventional medicines.
(It is worth commenting that homeopathic and herbal medicines
are often confused in the Public's mind.) Despite the longevity
of homeopathy no plausible scientific reason has yet been proposed
as to why it should work. Further, as yet no unambiguous clinical
trial data has been presented as evidence for the effectiveness
of a homeopathic preparation.
3.02 Homeopathy is proposed to work on the
principle of "treating like with like" and uses extremely
dilute amounts of the homeopathic substance to treat an illness
with symptoms that large doses of the same substance would actually
cause in healthy patients. The philosophy of homeopathy that a
substance becomes more potent as it is diluted goes against the
conventional theory of the pharmacological action of compounds
in the body, which increase in activity with concentration. Homeopathic
preparations are made by repeated diluting and vigorous shaking
(succusion) of a stock until there is little, if indeed any,
of the original substance left. Successive succusion and dilution
steps are required to potentise the preparation.
3.03 Such is the extent of dilution used
in homeopathy that even the most concentrated homeopathic preparation
generally used (ie a 6C preparation) contains only one picogram
of homeopathic substance. (Conventional medicines are usually
administered in milligram or microgram, ie 106 or 103 higher amounts.)
The most commonly used preparation (a 30C preparation) is diluted
to such an extent that only one molecule of the homeopathic substance
would be present in a sphere the size of the orbit of the planet
Neptune. As a consequence of their extreme dilution, most high
dilution/potency homeopathic remedies do not contain a single
active molecule. The administration of a preparation containing
substance at such large dilutions leads to a RPSGB view that such
preparations will not produce clinical effects.
3.04 To explain the activity of the homeopathic
preparation, homeopaths state that the homeopathic substance leaves
a molecular "imprint" in the preparation that triggers
your body's healing mechanisms, that the dilution and succusion
steps are essential to the efficacy of the remedy, and that the
more dilute the preparation, the more effective it becomes. However
there is no robust scientific evidence to suggest that differences
can be detected between ultra dilute homeopathic remedies and
the diluent used to prepare the remedy in terms of their physical
properties and behaviour.
3.05 In 1986, an RPSGB Council Statement
on homeopathic products stated that with regard to homeopathic
remedies, there was no scientific evidence for their efficacy,
only anecdotal or subjective reports. A 2006 Law and Ethics
bulletin reported that there was no scientific proof that homeopathic
remedies were effective in preventing malaria.
3.06 In 1999, the RPSGB submitted a report
on complementary and alternative medicine to the House of Lords
Science and Technology Committee. In the report, a literature
review of the efficacy of homeopathic medicines was presented
which considered two recent meta-analyses. In summarising the
available evidence, it was noted "the equivocal outcome of
these two meta-analyses, which represent the best cumulative evidence
on homeopathic remedies to date, together with the absence of
a scientific basis for efficacy, implies that there is no scientific
basis for the use of homeopathy to treat any specific clinical
condition. However, a non-pharmacological therapeutic benefit
from the administration of a homeopathic remedy in an individual
patient can not be ruled out."
3.07 An Information Sheet produced on Homeopathy,
which forms part of the "Pharmacists—the scientists
in the high street" series was commissioned by the RPSGB's
Science Committee, the most recent update of which was produced
in June 2007. In reviewing the research on homeopathic remedies,
it stated "there is no sound pharmacological or scientific
basis for their activity. Conversely, there are many anecdotal
accounts of effectiveness."
3.08 A literature review of the evidence
to date for homeopathy carried out in 2009 for RPSGB's Science
Committee came to a very similar conclusion (see Appendix 1).
The main points that came out of this summary were
(1) Relatively few randomised, controlled clinical
trials (RCTs) have been carried out in the field of homeopathy.
(2) Of the many systematic reviews and meta-analyses
of homeopathy RCTs, the majority showed that either there was
no convincing evidence that homeopathy was superior to placebo,
or that there was not enough evidence to draw conclusions.
(3) A recent Cochrane review reports preliminary
data to support the use of specific homeopathic preparations to
treat adverse effects of cancer treatments. Meta-analyses of homeopathy
RCTs suggest that homeopathy may also be of some benefit in postoperative
ileus and acute pollinosis, and possibly in childhood diarrhoea.[1]
(4) High quality RCTs tend to show that the effects
of homeopathy are similar to placebo; lower quality trials tend
to show an effect for homeopathy superior to placebo.
(5) Arguments regarding the design and methodology
used for RCTs are made by both proponents and opponents of homeopathy.
(6) The placebo effect can be powerful and should
not be underestimated, but is only effective for relatively minor
ailments.
(7) There is evidence that patients receiving
individualised homeopathic treatment report clinical improvements.
(8) More high quality research in homeopathy
is required to increase the knowledge base. This includes RCT's
covering the treatment of specific clinical conditions, as well
as the effects of specific remedies. Furthermore, methodologies
that encompass the holistic or individualised care approach of
homeopathy need to be developed.
3.09 However as homeopathy is a whole person
treatment it does not lend itself well to testing through the
placebo-controlled randomised trial since significant components
of the treatment may be the interaction and trust building with
patients that may be compromised if the patient has a chance of
receiving a placebo. The classic homeopathic approach of one treatment
per one person contrasts with the conventional approach of one
or more therapies per disease, which may make many of the randomised
controlled study designs inappropriate for homeopathic research.
Despite this, most trials of homeopathic medicines do not individualise
treatments for patients. Interestingly results from meta analyses
suggest that in cases of individualised treatment, homeopathy
may have an effect over placebo.
3.10 While there is no sound pharmacological
or scientific basis for the activity of homeopathic remedies,
there are many anecdotal accounts of effectiveness. In this context
the placebo effect can be powerful and should not be underestimated,
but is only effective for relatively minor ailments.
In conclusion there is no scientific or clinical
evidence to support homeopathy, although in spite of this, patients
still report beneficial effects, especially from individualised
patient treatments.
November 2009
1 Since this document was produced in May 2009, further
examination of the references cited in the Cochrane review suggest
that although the Calendula product showing benefit in the treatment
of the adverse effects of cancer was produced according to a homeopathic
pharmacopoeia, its characteristics were more akin to a herbal
preparation. Back
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