The Bleakest Day for Homeopathy
The much anticipated House of Commons report into the Evidence Check on Homeopathy has now been published and it may well be the report that changes the face of homeopathy in the UK. But more than that, its implications will also be felt around the world.
In a thorough appraisal of the issues and evidence that will become required reading for any health official looking at the public funding and provision of homeopathy, the MPs conclude,
By providing homeopathy on the NHS and allowing MHRA licensing of products which subsequently appear on pharmacy shelves, the Government runs the risk of endorsing homeopathy as an efficacious system of medicine. To maintain patient trust, choice and safety, the Government should not endorse the use of placebo treatments, including homeopathy. Homeopathy should not be funded on the NHS and the MHRA should stop licensing homeopathic products.
The Evidence Check was called to look at the evidence base that has influenced government policy regarding homeopathy. The policy areas focussed on two main issues: the specific funding of homeopathy centres within the NHS and the regulation and labelling of homeopathic products. MPs called for submissions from interested parties about the nature of evidence and how it was influencing policy.
Both areas have come under intense criticism from the MPs. Of course, the central question of evidence into the policy concerning such areas must be the evidence of the effectiveness of homeopathic treatment. The evidence submitted by homeopaths was a complete ragbag, ranging from the selective, the misleading, the irrelevant to the bizarre.
"It is unacceptable for the MHRA to license placebo products—in this case sugar pills—conferring upon them some of the status of medicines."
As such, homeopathy will be under more pressure than it could have conceived possible. It may not be that this government acts on this report – elections are looming – but that is not important. Within PCTs, the NHS will start rethinking and no doubt start unwinding provision for it. There will be a ratchet effect. Bit by bit, funding will stop, never to return. West Kent PCT has done so. The likes of Liverpool, Glasgow, Bristol and London will surely follow. The Medicines Regulator will be under strong pressure to review its stance as it is clearly complicit in misleading the public with how it allows homeopathic products to be labelled.
So, what does the report conclude?
It appears to be a very well thought out document. Firstly, it sets out what its expectations of government would be for making policy on homeopathy:
Our expectations of the evidence base relevant to government policies on the provision of homeopathy are straightforward. We would expect the Government to have a view on the efficacy of homeopathy so as to inform its policy on the NHS funding and provision of homeopathy. Such a view should be based on the best available evidence, that is, rigorous randomised controlled trials and meta-analyses and systematic reviews of RCTs. If the effects of homeopathy can be primarily attributed to the placebo effect, we would expect the Government to have a view on the ethics of prescribing placebos.
The report then starts to look at the evidence, starting with the plausibility problem. It damns homeopathy before dilutions are even mentioned:
We conclude that the principle of like-cures-like is theoretically weak. It fails to provide a credible physiological mode of action for homeopathic products. We note that this is the settled view of medical science.
Water memory and the dilution problem are rejected outright. Furthermore, calls for more research into the hypothesis are questioned, "Research funding is limited and highly competitive. The Government should continue its policy of funding the highest quality applications for important scientific research determined on the basis of peer review."
They leave the decision to government funding to be settled by the chief scientists.
We recommend that the Government Chief Scientific Adviser and Professor Harper, Chief Scientist at the DH, get together to see if they can reach an agreed position on the question of whether there is any merit in research funding being directed towards the claimed modes of action of homeopathy.
On the question of clinical evidence, the MPs assess the overall conclusions of the best reviews and conclude simply: "In our view, the systematic reviews and meta-analyses conclusively demonstrate that homeopathic products perform no better than placebos."
However, the Chief Scientist at the Department of Health came under particular criticism for being equivocal about the evidence and appearing to suggest that there was a “lack of agreement between experts working in the field”. The MPs could find no evidence of such a lack of agreement.
And so, again, the MPs ask the Chief Scientists to get together and form an opinion as to whether there is any real controversy here.
On the evidence submitted by homeopaths, they are damning,
We regret that advocates of homeopathy, including in their submissions to our inquiry, choose to rely on, and promulgate, selective approaches to the treatment of the evidence base as this risks confusing or misleading the public, the media and policy- makers.
On the question of funding more clinical research, the MPs again are clear,
There has been enough testing of homeopathy and plenty of evidence showing that it is not efficacious. Competition for research funding is fierce and we cannot see how further research on the efficacy of homeopathy is justified in the face of competing priorities.
Even more damningly, they question the ethics of homeopathy trials,
It is also unethical to enter patients into trials to answer questions that have been settled already. Given the different position on this important question between the Minister and his Chief Scientist, we recommend that the Government Chief Scientific Adviser, Professor John Beddington, investigate whether ministers are receiving effective advice and publish his own advice on this question.
The MPs anticipate the reaction of homeopaths that homeopathy works in ‘real life’ scenarios. They look at the various ‘satisfaction surveys’ that come out of homeopathic hospitals and conclude,
We do not doubt that homeopathy makes some patients feel better. However, patient satisfaction can occur through a placebo effect alone and therefore does not prove the efficacy of homeopathic interventions.
(I suspect strongly we shall see some homeopaths quote mining this section!)
It is therefore inevitable that the MPs should ask the NHS PCTs to consider whether spending money on homeopathy is cost effective,
We recommend that the Department of Health circulate NHS West Kent’s review of the commissioning of homeopathy to those PCTs with homeopathic hospitals within their areas. It should recommend that they also conduct reviews as a matter of urgency, to determine whether spending money on homeopathy is cost effective in the context of competing priorities.
Given that it is almost certain that homeopathy is nothing but a placebo, should doctors still be allowed to prescribe it? There are feelings that a placebo may well help some patients. However, the MPs again were very straightforward here in their conclusions about prescribing placebos: "When doctors prescribe placebos, they risk damaging the trust that exists between them and their patients."
One of the central arguments from homeopaths is that the NHS should provide the choice to be treated with homeopathy. ‘Choice’ is the big buzz word in health at the moment. The MPs again do not see homeopathy providing extra real choices for patients,
For patient choice to be real choice, patients must be adequately informed to understand the implications of treatments. For homeopathy this would certainly require an explanation that homeopathy is a placebo. When this is not done, patient choice is meaningless. When it is done, the effectiveness of the placebo—that is, homeopathy—may be diminished. We argue that the provision of homeopathy on the NHS, in effect, diminishes, not increases, informed patient choice.
This thinking is extended to the new concept of ‘personal health budgets’ that are being trialed at the moment: "We recommend that if personal health budgets proceed beyond the pilot stage the Government should not allow patients to buy non-evidence-based treatments such as homeopathy with public money."
And quite critically, the MPs recognised that NHS funding of homeopathy could harm people by appearing to endorse nonsensical treatments. They noted that most people do not understand what homeopathy is – thinking it is a ‘herbal’ treatment.
When the NHS funds homeopathy, it endorses it. Since the NHS Constitution explicitly gives people the right to expect that decisions on the funding of drugs and treatments are made “following a proper consideration of the evidence”, patients may reasonably form the view that homeopathy is an evidence-based treatment.
The overall conclusion must be the bleakest conclusion for the supporters of homeopaths in the UK.
We conclude that placebos should not be routinely prescribed on the NHS. The funding of homeopathic hospitals—hospitals that specialise in the administration of placebos—should not continue, and NHS doctors should not refer patients to homeopaths.
The Royal London Homeopathic Hospital is probably the most famous state funded homeopathy clinic in the world. Its closure will be a bitter blow to all supporters of this quackery. However, it will be a very good thing to all those subjected to quack medicine in India and Africa where homeopaths use the UK state funding of homeopathy as an endorsement for their own dangerous policies and practices. This is a good day for the health of the poor and exploited.
The MPs move on the the licensing of homeopathic remedies and how the MHRA handle it. This is an area I am particularly interested in as I submitted evidence of the failure of the MHRA to uphold their own rules. The first blow to the homeopathic industry is the call for the ending of the Public License of Right which gave exemptions to homeopathic products when the Medicines Act was introduced,
We are concerned that homeopathic products were, and continued to be, exempted from the requirement for evidence of efficacy and have been allowed to continue holding Product Licences of Right. We recommend that no PLRs for homeopathic products are renewed beyond 2013.
This will send shock waves through the manufacturers of sugar pills. My guess is that this is a far more deeply reaching conclusion that they were expecting.
The MPs conclusions about the MHRAs position are quite amusing…
The absence of a requirement to show evidence of efficacy means that the MHRA’s current arrangements would allow a person to seek, for example, a licence for a confectionary product as long as he or she persuaded a number of people that it was a homeopathic product with therapeutic effects. Such a development would, rightly, bring the licensing arrangements into disrepute. We are concerned that the lack of rigour in the MHRA’s licensing processes by, for example, allowing the use of provings is allowing homeopathic products to build medical claims unsupported by any evidence. We conclude that the MHRA should seek evidence of efficacy to the same standard for all the products examined for licensing which make medical claims and we recommend that the MHRA remove all references to homeopathic provings from its guidance other than to make it clear that they are not evidence of efficacy.
The testing of the publics’ understanding of the labeling of homeopathic products was found to be ‘flawed’ "the MHRA’s testing of the public’s understanding of the labelling of homeopathic products is defective."
As I suggested a few weeks ago, the MPs suggest that if there are to be new labels, they should make it clear that there is no active ingredient,
If the MHRA is to continue to regulate the labelling of homeopathic products, which we do not support, we recommend that the tests are redesigned to ensure and demonstrate through user testing that participants clearly understand that the products contain no active ingredients and are unsupported by evidence of efficacy, and the labelling should not mention symptoms, unless the same standard of evidence of efficacy used to assess conventional medicines has been met.
The role of pharmacists in selling these products was questioned.
Pleasingly for me, the MPs directly address my concern about the lack of enforcement of the existing rules. They quote me on how Ainsworths sell remedies for mumps, measles, typhoid and TB and appear to be getting away with it,
Although it goes wider than the scope of this Evidence Check inquiry we must put on record our concern about the length of time the RPSGB appears to be taking to investigate and reach conclusions on cases where it has been alleged that its guidelines on the sale of homeopathic products have been breached. We recommend that the Government enquires into whether the RPSGB, and from the 2010 handover, the General Pharmaceutical Council, is doing an adequate job in respect of the time taken to pursue complaints.
The overall conclusion is damning for the industry and there must be very many worried homeopathic sugar pill retailers,
It is unacceptable for the MHRA to license placebo products—in this case sugar pills—conferring upon them some of the status of medicines. Even if medical claims on labels are prohibited, the MHRA’s licensing itself lends direct credibility to a product. Licensing paves the way for retail in pharmacies and consequently the patient’s view of the credibility of homeopathy may be further enhanced. We conclude that it is time to break this chain and, as the licensing regimes operated by the MHRA fail the Evidence Check, the MHRA should withdraw its discrete licensing schemes forhomeopathic products.
This will indeed be the bleakest day for homeopathy.
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