Memorandum submitted by Les Rose HO 10

1 Licensing

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 products - and 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 rules.

2 Funding

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 Evidence

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 ineffective.

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 informed choice.

Les Rose BSc CBiol FSB FICR MAPM

Declaration of Interests

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.

November 2009