Memorandum submitted by Dr Andy Lewis
(HO 11)
GOVERNMENT POLICY
ON LICENSING
OF HOMEOPATHIC
PRODUCTS
1. Currently, the licensing of homeopathic
products is not made on the basis of evidence. This is in stark
contrast to how other medicinal products are licensed in this
country. Indeed, it would only be possible to give MHRA licences
to homeopathic products if the requirement of evidence of efficacy
were dropped as these products are not medicinal products but
pseudomedical products based on magical thinking and pre-scientific
ideas.
2. The MHRA allow sellers to submit evidence
from homeopathic "provings" as evidence. A proving is
where a homeopath takes a new type of homeopathic pill to see
what symptoms it generates. Homeopaths believe "like cures
like", so an onion, which makes your eyes stream, can cure
hayfeverallegedly. However, homeopathic pills have been
so diluted that no ingredients actually remain. What homeopaths
"prove" is plain sugar pillsany symptoms they
note are either coincidental or imaginary. There is no good evidence
to suggest that homeopathic proving are a reliable means of generating
a homeopathic "symptom picture". The largest ever controlled
homeopathic proving showed that there were no observable effects.[30]
This is consistent with proving being nonsense and MHRA rules
relying on nonsense methods to show efficacy.
3. Despite the regulations, many homeopathic
pharmacists continue to sell homeopathic pills with specific indications
without a license. To test this, last year, visited London's Nelson's
Homeopathic Pharmacy just off Oxford Street. I went in and said
I needed something for an upset stomach and that I had diarrhoea.
"Do you have anything like Imodium?" I was told that
the stuff they had would not just "suppress my symptoms"
4. I was given a tub of pills with the following
label:
TRAVELLER'S DIARRHOEA
RELIEVES SYMPTOMS OF DIARRHOEA & VOMITING DUE TO CONSUMPTION
OF UNWASHED FRUITS, VEGETABLES, BAD MEAT OR FISH. DOSAGE. TAKE
2 TABLETS EVERY HOUR UNTIL BETTER ARSENICUM 30/PODOPHYLUM
30/PYROGEN 6/CARBO VEG 30/NUX VOMICA 30 EXP 12/12 KEEP OUT
OF CHILDRENS REACH NELSON'S HOMEOPATHIC PHARMACY 73 DUKE
STREET, LONDON W1K 5BY 020 7629 3118 P
5. On 28 March 2008, I submitted an
enquiry to the MHRA suggesting that this might be an illegal product
as it had no marketing authorisation. On 14 April 2008 I
was told that the case had been passed onto the MHRA's Enforcement
and Intelligence Group. I finally got a reply some 17 months
later to tell me that "The outcome of the investigation is
that following advice from the Enforcement Unit, Nelson's have
removed the product you mentioned from their display shelves."
6. To date, the product is still available
for sale[31]
on the Nelson's web site along with many other similar products
with specific indications. You can also see other similar products
that are intended to cure constipation, accident & injury,
allergic reactions, bites & stings, hangover & indigestion,
heat exhaustion, jet lag, and sun exposure. All are similarly
ineffective.
7. Whilst these conditions may be relatively
minor, other homeopathic pharmacies sell remedies for much more
serious conditions. Neal's Yard Remedies were selling sugar pills
to customers and telling them that these could prevent malaria.
The BBC undertook an investigation and interviewed their "Medicines"
Director, who stormed out of the meeting after being asked if
this was ethical and legal.[32]
After the BBC forwarded on their evidence, the MHRA investigated
and merely slapped their wrists. This is despite the fact that
this product has the potential to kill if taken in the place of
a real malaria prophylactic.
8. It would appear that the MHRA take a
very light touch and piecemeal approach to investigating this
widespread abuse of the regulatory system.
Examples of other products are: Migraine Headaches
(Helps with migraine symptoms.)
http://www.nelsonshomeopathy.com/shop-online/Migraine-Headaches_prod1628.aspx
9. Homeopathic pharmacies are full of products
with direct and implied claims. In order to understand the extent
of the problem it is necessary to understand mainstream homeopathic
beliefs. The pharmacies are stocked with products that are often
derived directly from diseased tissues, vaccines and infectious
samples. These are designed to treat or prevent the diseases they
are derived from. Visiting a homeopathic pharmacy web site will
show many products with implied indications.[33]
These are often in the form of what homeopaths call nosodes
where some diseases tissue or some other "infectious"
agent is taken and serially diluted and shaken and probably banged
against a leather bible many times to create the homeopathic pill.
The remedy lists of Ainsworths show products for each Influenza
strain going back 20 years. You will find homeopathic replacements
for Measles vaccine, Parotitis vaccine (mumps) and Rubella. You
find homeopathic sugar pills for all forms of Hepatitis, strains
of TB, and Typhoid, as well as the usual comedy remedies such
as shipwreck, trout and Ayres rock.
10. These products are making implicit claims
to be alternatives to real vaccines. They would appear to be all
unlicensed remedies.
11. In my opinion, it is a mistake to regulate
homeopath products as if they were medicines, with or without
different levels of evidence for efficacy. Homeopathy is not a
medicine. It is a pseudo-medicine with believers who belong to
more of a cult than a profession. It is a disgrace that these
products can appear on the same shelf-space as real medicinal
products with misleading claims ratified by the MHRA. Claims made
or implied by homeopaths should be subject to Trading Standards
laws rather than given the false legitimacy of MHRA approval.
12. It is wrong to allow this to continue
on the basis of consumer "choice". Choice can only be
meaningfully be exercised when it is informed. In buying medicines,
we so often have to defer to expertswe cannot always check
all claims all the timewe are all "vulnerable"
consumers in this context. The MHRA has an overriding duty to
ensure it is not helping to mislead consumers when they are making
their choices about medicines.
THE EVIDENCE
BASE ON
HOMEOPATHIC PRODUCTS
AND SERVICES.
13. It is absurd to continue to question
the evidence base of homeopathy. The question was settled in the
1830's. It is only homeopaths who continue to believe that there
is something special going on in their pills. If homeopathy had
not been invented around 1800 but turned up today, would
be seriously be considering funding this with millions of pounds
in the NHS? The concept would appear absurd and the work of fevered
imaginations. It is mere familiarity of this delusion that stops
us taking this approach now.
14. Homeopaths continue to press that there
is an evidence base. This is usually based on the following fallacies:
(a) A "wealth" of positive evidence.
Of course, it is possible to make a case for any absurd proposition
if you only present positive evidence. Clinical research can very
often create false positive results by chance, poor study design
or fraud. In order, to evaluate a proposition, all evidence must
be taken into accountpositive, negative and neutral. Homeopathy
does not stand up to such scrutiny.
(b) Selective quoting of review conclusions.
Many systematic reviews have show the weakness of the evidence
base. However, within such reviews there have been some hints
of positive results. It is now thought that such hints are the
result of poor input studiesgarbage in, garbage out. As
the years have gone by, the reviews have become more sophisticated
and clearly shown that studies with better methodologies and larger
numbers of participants fail to show positive effects for homeopathy.
Shang (2005) is the most definitive here.[34]
Homeopaths have attempted to discredit Shang. They
have failed. They assert that Shang would have come to different
conclusions if different studies or different criteria were included.
This is self evident and irrelevant. Shang could be discredited
if homeopaths could show a quality reanalysis that came to a conclusion
opposite to that giventhey have not been able to do so.
(c) Claims of success in distant lands and distant
times. Very often claims exist that homeopathy cured the 1918 flu
epidemic or is used successfully in Cuba. These are anecdotal
stories with no hard evidence to back them up.
(d) Claims of physical experiments that show
genuine effects of the "memory of water". None of these
experiments have been taken seriously and have not been authoritatively
replicated.
(e) Claims that quantum mechanics hold the answer.
A few academics have fiddled with the language of quantum theory
and tortured it into the world of magic medicine. It is muddled
and unconvincing and the authors involved appear to have a very
poor grasp of the quantum theory.
DECLARATION OF
INTERESTS
I am a writer about quackery on the web site
quackometer.net. It is a hobby. I have no financial interest matters
relating to medicine or pseudomedicine.
November 2009
30 Ultramolecular homeopathy has no observable clinical
effects. A randomized, double-blind, placebo-controlled proving
trial of Belladonna 30C. Brien S, Lewith G, Bryant T. Br J Clin
Pharmacol. 2003 November;56(5):562-8. Back
31
http://www.nelsonshomeopathy.com/shop-online/The-Nelsons-Travellers-Companion_prod1731.aspx Back
32
http://news.bbc.co.uk/1/hi/england/devon/7385718.stm Back
33
http://www.ainsworths.com/site/combination.aspx Back
34
Are the clinical effects of homoeopathy placebo effects? Comparative
study of placebo-controlled trials of homoeopathy and allopathy.
Lancet. 2005 August 27-September 2;366(9487):726-32. Back
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