Memorandum submitted by Les Rose (HO 10)
1.1 The National Rules Scheme
This allows homeopathic products to bear therapeutic
indications, and is not based on any evidence at all. The MHRA
consultation which preceded the new legislation, MLX312, openly
admitted that "homeopathic products have difficulty in demonstrating
efficacy in clinical trials". As the MHRA rightly insists
on clinical trial evidence for orthodox drugs, this was the clearest
admission that the MHRA knew homeopathic products to be ineffective.
One reason that the MHRA gave for forcing though the rules was
that to do nothing would have inhibited the expansion of the homeopathic
industry. It is not at all clear as to why this was important
to the MHRA, or why it was in the public interest to be offered
an increasing number of ineffective productsand to be lied
to about their lack of effect. However the MHRA is not funded
by taxation but by fees, and it is certain that not issuing new
licences would have cut off an income stream.
1.2 Double Standards
The MHRA's report on the MLX312 consultation
minimised opposition and emphasised support from industry. Yet
the new legislation does not comply with classical homeopathic
teaching, which is that treatment must be individualised. The
labelling regulations cater for pre-packaged products available
in retailers such as (and especially) Boots, which are of course
not individualised. There can be absolutely no possibility of
the careful recording of history and symptoms which are the homeopath's
stock in trade. Yet the homeopathy companies supported the regulations
enthusiastically. This shows the level of duplicity endemic in
the practice of homeopathy.
Curiously, the first product to receive a licence
under the new rules was homeopathic arnica, which has most recently
been tested in clinical trials and found to be ineffective. Also,
it violates the "like cures like" principle of homeopathy,
so makes no sense even under the bizarre requirements of the new
2.1 Cash Costs
I have submitted a separate report on primary
care trust funding trends. There are however other costs of homeopathy.
For example, central government paid some £20 million
for the refurbishment of the Royal London Homeopathic Hospital.
The business case for this project said nothing at all about the
clinical outcomes that would result from this expenditure.
2.2 Potential Cost Savings
The actual amount of money spent on homeopathy
is a small part of the NHS budget. But it has the effect of undermining
the effort to make evidence based practice (EBP) the norm. Critics
of orthodox medicine state that a large proportion of it is not
evidence based. This is not true to the extent claimed, but apart
from falling victim to the tu quoque fallacy, it misses
the point. The NHS could make very large savings by progressing
more rapidly towards full EBP. There would be no better demonstration
of such a commitment than to close its homeopathic hospitals as
soon as possible.
Yet it is astonishing to see that the NHS seems
determined to repudiate EBP. It has just been announced that the
pilot patient budgets scheme will allow the money to be spent
on complementary medicine, including homeopathy. If the idea of
this scheme was to put patients in control of their health, what
message does this transmit? Here was an opportunity to educate
patients about cost-effectiveness, but instead they are put in
charge of wasting public money. Patients will therefore demand
the right to spend their budgets on whatever they like. There
is a virtually endless choice of medical fads and fashions to
feed that demand.
3.1 The Quality of Evidence
It is important to focus on the best quality
evidence. Randomised controlled trials (RCTs) provide the most
rigorous test of a therapeutic claim. Homeopaths either denigrate
RCTs as inappropriate for their speciality, or select poor quality
RCTs that spuriously show positive results. They also cite uncontrolled
observational studies which are no more than customer satisfaction
surveys. It is true that a broad and inclusive approach needs
to be taken to clinical evidence. Thus pragmatic trials and observational
studies are part of the mix. But it is a serious mistake to rely
on these and to dismiss RCTs. Evidence based medicine is one of
the greatest achievements of science. It has the RCT at its core.
RCT evidence has overturned many accepted practices, often by
showing them to be harmful, and commonly by showing them to be
3.2 Spurious Evidence
Homeopaths claim that substances diluted beyond
Avogadro's number have specific therapeutic effects. RCTs, especially
when assembled into meta-analyses and systematic reviews, clearly
show that this is not true. Some homeopaths argue that specific
and non-specific effects cannot be separated (as do some sociologists).
These arguments try to recruit support from unrelated fields such
as quantum mechanics. For example, long papers have been written
on "patient-practitioner entanglement". No experimental
or observational evidence has been offered to support these ideas.
They are no more than a smokescreen to hide the fact that specific
effects of homeopathic dilutions do not exist.
3.3 The Ethical Dilemma
There is a serious ethical problem if treatments
that are effectively placebos are to be offered to patients. Doctors
are required by the terms of their registration to give treatments
that they reasonably expect to be effective. By any scientific
test, homeopathic products are ineffective, placing them outside
EBP. Also, doctors have to obtain informed consent for treatment.
Therefore to prescribe homeopathy doctors must inform patients
that they are giving them a placebo. They must convey to patients
what the scientific evidence is. This is a principle that is extremely
poorly enforced by the GMC and the medical Royal Colleges. The
various professional bodies for homeopaths ignore EBP altogether,
as does the voluntary regulation scheme launched by the Complementary
and Natural Healthcare Council. This is dishonest, and demeaning
for patients. If patient choice is to mean anything, it must be
I am a freelance clinical science consultant
with over 30 years of experience in clinical research. I
do voluntary work for two charities, Sense About Science and HealthWatch,
in support of evidence based medicine. I do not receive any payments,
in cash or in kind, for these activities. Most of my professional
clients are pharmaceutical companies, but they have no connections
with this voluntary work.
Les Rose BSc CBiol FSB