Further documents have been published after the House of Commons held its enquiry into the evidence base for government policy on homeopathy. There are some real treats in there, but I am most concerned about new evidence from the Medicines and Healthcare Products Regulatory Agency (the MHRA) on how they test the public’s understanding of the labeling of homeopathic products.
The new document was submitted to the enquiry after Professor Kent Woods (pictured) was challenged over how the regulator allows homeopathic products to make claims on their labels when it is known that these claims are false. The concern is that a customer could walk into Boots the Chemist and see two products for, say, hayfever and be unaware that the homeopathic product has no active ingredient, is just a sugar pill and will not help the relief of any symptoms. Clearly, this is a very unsatisfactory situation, where the medicines regulator is charged with ensuring medicines are safe and do what they claim but appears to wave homeopathic products through without regard to these principles. The public are being badly misled by the people charged with protecting them.
In the enquiry, Evan Harris MP asked a very pertinent question of Professor Woods,
Do you think that people reading that will think that it works for symptomatic relief of those minor conditions, or do you think that label that you have read out – and please feel free to read it out again – would make the average person think, which is the truth, as far as you are concerned, that there is no evidence of efficacy backing it up. Which of those two do you think is most likely, for the average person?
At is issue is the question of how far the MHRA go to ensure that the public are not being misled by the labeling they authorize on homeopathic products.
Professor Woods response was,
Well, fortunately, by law all packaging and patient information leaflets are subjected to user testing to ensure that they are comprehensible to the man in the street, and indeed that seems to be a very straightforward statement of the reality. This is a homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of sprains, muscular aches and bruising or swelling after contusions. That is what it says and the user testing is part of the approval of that leaflet, has the labeling been tested on the average man in the street.
This did not satisfy the MP, Dr Harris,
Sadly my question was not “What does it say? Has it been tested?” My question is, and maybe it is the result of this testing and you need to tell me, does the average person think that that label suggests that it is going to be useful for the symptomatic relief of those indications?
This is an important question. Does the MHRA care if the public are misled by homeopathic labeling or not? What do people make of the labels?
The new documents posted on the House of Commons web site shed light on this question.
It is worth reporoducing the test questions that are used to establish what people make of the labeling on a homeopathic product:
Three rounds of user testings were carried out with ten participants in each testing. Twelve questions relating to the key safety messages were asked and were designed to assess whether the respondent was able to find the information, understand it and use the information. The questions asked were as follows:
1. Can you tell me the name of this medicine?
2. What does the label say that this medicine is for?
3. If you take too much of this product (overdose) what does the label tell you to do?
4. Is there any advice on the label for women who are pregnant or breast feeding?
5. What does the label say is the active ingredient in this medicine?
6. If you have missed a dose of this medicine, what does the label tell you to do?
7. Once you have opened your medicine, how does the leaflet tell you that you should store it?
8. This medicine contains Arnica Montana 30C. What are the other ingredients in this medicine?
9. How many pillules are there in the Clikpak container?
10. This medicine contains lactose and sucrose which are types of sugar. If you have an intolerance to some sugars, what does the pack tell you to do before taking this product?
11. How many pillules does the pack say that you should take in a dose and how many times a day should you take them?
12. The pillules in this medicine are contained in a plastic Clikpak to help protect them. What instructions does the label give you as to how to dispense the pillules from the Clikpak?
These questions fail to address the central concern that labeling homeopathic products for the relief of specific symptoms is going to mislead patients into thinking that there is reason to believe this is true and that there is evidence to back up the stated claims. In my opinion, the MHRA is complicit in supporting a fraud on the public.
Question 2 is quite insidious in my view. It tests to see if the subject understands the medicine is targeted at specific conditions, when there is no evidence to suggest that the medicine can help. What would the answer to the question mean? Question 5 implies there is an active ingredient in the pill. If the test subject answered ‘Arnica’ would the MHRA conclude that the patient has been deceived by the packaging or has just read the label and concluded that it is telling the truth?
Question 8 explicitly states that the pill contains “Arnica Montana 30C”. Only someone with a good understanding of the nonsensical production methods of homeopathy would appreciate that this means that the pill does not contain any Arnica (it has all been diluted away). What would the average customer on the street conclude? In the original hearing, Professor Woods states that the labeling is designed for people who believe in homeopathy,
To begin with the fact that this is a homeopathic remedy, we are making provision for a group of people who believe in homeopathic remedies and, therefore, the first thing to establish is that this particular remedy is recognised by homeopathic practitioners as a homeopathic remedy. That is the essence of what we are trying to prove.
This is simple nonsense, as the products are likely to end up on the shelves of Boots where people may simply misread ‘homeopathic’ as ‘natural’ rather than ‘batshit magic pseudo-medicine’, the wording that ought to be on the label.
The MHRA appear to completely miss the point over homeopathy. As I have written before, they fail twice over. Firstly, they endorse misleading labels on homeopathic products and fail in their primary mission to “ensure that medicines and medical devices work.” Secondly, they appear to be blind to the blatant abuses that do go on in the creation of homeopathic medicines where claims are made explicitly and implicitly without even seeking MHRA approval.
The mistake that all regulatory efforts from this government has made is to attempt to regulate alternative medicines as if they were medicines. They are not: they are pseudo-medicines and need a different style of thinking. Trading Standards should take a more leading role in prosecuting misleading claims as they would with any other consumer product. The MHRA need to stop feeling they need to treat homeopathy as if it were medicine and give special dispensations in the claims that they can make. As with any other medicine, homeopathy should only be allowed to make claims if they can back them up with sound evidence.
I understand that there are some efforts within the MHRA to look into the issues I have raised with them. It has been several months since I last heard from the investigating officer involved. My first enquiry took 17 months for a response. In the meantime, I hope the the upcoming publication of the House of Commons Evidence Check report into homeopathy will be severely critical of them for presiding over a regulatory regime that endorses the homeopathic trade in misleading the public.