The other day, Martin wrote about the MHRA’s label test for Arnica 30C. I think that perhaps he was a touch unfair. This was only a label test, and not intended to be anything else. The purpose is to ensure that the label is clear to consumers (you can’t have patients when the ‘medicine’ is just magic water) and that it accurately conveys what is supposed to be in the bottle.

Admittedly, this is logically redundant since homeopathic tinctures are only distinguishable by the label, so whatever it says is what’s in it (for a given (infinitesimally small) value of ‘in’); but I suppose that for the sake of fairness to the poor deluded fools who are putting their faith in this magic water, it’s only right that they ought to be able to tell what was once in the same factory as a drop of water which once shared a continent with the bottle they are looking at.

To be a successful civil servant, it is necessary sometimes to embrace the ridiculous. As Disraeli might have put it, ‘Damn your principles! Stick to the process’. Once the decision has been taken to permit licenses for homeopathic potions, the processes to follow flow naturally, and so we end up in logical dead-ends like this.

To be fair to the MHRA, their decision on homeopathy is merely a logical conclusion of the decision, taken in around 1992 to make medicines part of the free market (Directorate General (DG): Enterprise & Industry) rather than healthcare (DG: Sanco), a decision which has recently been rectified, and the ramifications of which (including some fascinating analysis of one of the Lisbon treaties!) I'll blog about tomorrow(ish).

Of course, just because one is following the process to its logical conclusion, it doesn’t mean that one is doing so well. Regarding the actual clarity of the label, Dr Evan Harris completely skewered Professor Woods on the misleading nature of the permitted claims. Here’s an excerpt from the uncorrected transcript of oral evidence. My favourite is Q229, but the whole document (and in particular this extract) makes for entertaining reading:

Q226 Dr Harris: Professor Woods, let's take this arnica example since 2006. I think you accepted that you do not require any evidence of efficacy before allowing a health claim to be made for the indication for that product, is that right? Because provings, you said, were not an indication of efficacy.
Professor Woods: They are not in any sense analogous to evidence of efficacy.

Q227 Dr Harris: So you do not require any evidence of efficacy before allowing an indication on that label under this National Rule Scheme?
Professor Woods: The descriptor on the packet says, which is agreed with the Regulator: "A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of sprains, muscular aches, bruising and swelling". That is what we wish to confirm and this is used within the homeopathic tradition for that purposes. It is not the same as us accepting it as evidence.

Q228 Dr Harris: It is helpful to have that on the record. Now, if you could answer my question, you do not require any evidence of efficacy for that to have been agreed to be the wording on the label?
Professor Woods: No.

Q229 Dr Harris: 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?
Professor Woods: 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 labelling been tested on the average man in the street.

Q230 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?
Professor Woods: I cannot really speak for everybody who reads that --

Q231 Dr Harris: What about the testing you did? What is the result of the testing? Did most people read that as saying "This is not going to work but I might try it anyway", or that it might be useful? What?
Professor Woods: The testing was that the messages attached to this were clearly understood.

Q232 Dr Harris: But what was the understanding, because you cannot tell if they are clearly understood unless you find out what the understanding is, unless we are in a parallel universe?
Professor Woods: 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. We are not trying to make any statement whatever as to whether it works or not. I would add, however, that there are several other things relating to the package of information. One is, as you see, the explicit statement this is homeopathic. Secondly, there is the requirement on the packaging that if the condition persists for longer than seven days they seek a clinician's advice.

Q233 Dr Harris: I will come back to that because what it does not say is there is probably no active molecule if this is beyond 14C dilution active, which many of them are, so it does not explain what homeopathy is. So let's work on the assumption that a label that says: "This is used for the symptomatic relief" makes the average person think that it is useful for the symptomatic relief, and I would put it to you that that is not a huge leap. So do you think the public is helped, and that is your mission, by patients being led to believe that something is useful for a symptom when there is no evidence that it is useful for a symptom? Is that something that makes you as a clinician happy, your organisation having that effect?
Professor Woods: You are asking me two questions, one about regulation and one about what I personally believe. I have practised medicine for 30 years and I have never deliberately prescribed a patient a placebo, but the point is that there is a significant group of people who accept and choose to believe the homeopathic tradition. If you take a simple example, somebody with a sprain who is going to get better from a minor inconvenience can walk down to their chemist and either buy themselves this product or a bottle of aspirin, and within a week the sprain will have got better anyway. Which of those two courses of action is the greater risk to their health?

Subsequent to Prof Woods’ appearance before the committee, the MHRA’s 2005 public consultation on the regulation of homeopathy was released. Martin hit the nail on the head with his criticism of this, and I’m grateful that he blogged about it and brought it to my attention. I’m mainly grateful because I’m a bit of a EU legislation geek.

In response to a number of replies asking for some statement regarding the lack of proof of efficacy (numbers 4 & 26), the MHRA provided the following answer:

Homeopathic products must be labelled in accordance with Article 54 (labelling requirements), Article 59 (package insert requirements) and Article 68 (which requires that the homeopathic nature of the product is clearly stated) of the European Directive. There is no provision in the Directive for any other information to be included. In order to make the user aware that of the homeopathic nature of the product, they are clearly labelled ‘Homeopathic medicinal product’ and the indication is state as ‘A homeopathic medicinal product used within the homeopathic tradition to relieve…’

I’m going to focus on what I see as the misinterpretation of the EU legislation.

The Directive they refer to is Directive 2001/83/EC, as amended. The points on articles 54 & 59 are not the most relevant – Article 69 makes it clear that homeopathic ‘medicines’ aren’t to be labelled like real ones, however since Kent reckons that they’re relevant, I’ll treat them as though they are, and show just where I’d enforce appropriate labelling. If you’re not turned on by analysis of EC Directives, and want to get to the meat of the MHRA’s non-compliance, then skip ahead to Article 69…

Article 54 states

The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:
(a) the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the product contains up to three active substances, the international nonproprietary name (INN) shall be included, or, if one does not exist, the common name;
(b) a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;

The particulars go up to (n), but I’ll leave it there, as this covers the important parts.
In Article 54, the word “only” is noticeable by its absence. The lack of this word allows, for example, manufacturers logos, or pictures of a tablet targeting a particular area, or whatever else the companies want to put on there. It would also allow a regulator to impose additional restrictions, such as having a phrase relating to the lack of any proven efficacy. Notable by its presence is paragraph (b), in particular the following words “a statement of the active substances expressed qualitatively…” If that doesn’t permit a phrase about how there’s literally nothing in it, then I really don’t know what does.

Article 59 deals with the package insert. It’s on page 41 of the directive if you wish to read it for yourself. I’m just going to highlight, with context, the points where I think a valid argument could be made for including references to the lack of any active ingredient or evidence for efficacy:

1. The package leaflet shall be drawn up in accordance with the summary of the product characteristics; it shall include, in the following order:
(a) for the identification of the medicinal product:
(i) the name of the medicinal product followed by its strength …
(b) the therapeutic indications;
(c) a list of information which is necessary before the medicinal product is taken: …
(iv) special warnings; (nb: this is normally for particularly relevant facts relating to things like drowsiness & driving, however one could, if one so desired, put other special warnings here, such as one relating to the total lack of any proof of efficacy)
(f) a reference to the expiry date indicated on the label, with: …
(iv) the full qualitative composition (in active substances and excipients) and the quantitative composition in active substances, using common names, for each presentation of the medicinal product;

Now we come to Article 68, which states, in its entirety

Without prejudice to the provisions of Article 69, homeopathic medicinal products shall be labelled in accordance with the provisions of this title and shall be identified by a reference on their labels, in clear and legible form, to their homeopathic nature.

For some reason, Kent Woods didn’t make any mention of Article 69. If he had, then maybe the MHRA’s decision to permit indications would have been shown to be erroneous.
Article 69

1. In addition to the clear mention of the words ‘homeopathic medicinal product’, the labelling and, where appropriate, the package insert for the medicinal products referred to in Article 14(1) shall bear the following, and no other, information:
- the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in accordance with Article 1(5); if the homeopathic
medicinal product is composed of two or more stocks, the scientific names of the stocks on the labelling may be supplemented by an invented name,
- name and address of the registration holder and, where appropriate, of the manufacturer,
- method of administration and, if necessary, route,
- expiry date, in clear terms (month, year),
- pharmaceutical form,
- contents of the sales presentation,
- special storage precautions, if any,
- a special warning if necessary for the medicinal product,
- manufacturer's batch number,
- registration number,
- ‘homeopathic medicinal product without approved therapeutic indications’,
- a warning advising the user to consult a doctor if the symptoms persist.

This means that, although one couldn’t have a statement saying that there’s literally nothing but water in a 30C dilution, the line I've emboldened means you also can’t have a statement saying “used within the homeopathic tradition for the symptomatic relief of sprains, muscular aches, bruising and swelling”.

The whole of Kent Woods’ arguments that articles 54 & 59 are the really relevant ones is rendered false at a stroke, and the decision to permit an indication, is clearly in breach of the requirements under Directive 2001/83/EC.

All things being considered, the MHRA’s actions on homeopathy and their justifications for same can only be described as perverse in the extreme. The only possible reason I can think for them having taken such a course of action is a belief that there is significant potential income to be derived from homeopathic licenses. Unfortunately, since only Arnica 30C has been licensed, and since they’ve had to pay for a focus group to assess the labelling, it seems that the net income will only be in homeopathic doses.

Tom

PS – I’m moderately excited to say that this is my first ever blog post. It’s only taken 4 months for me to find a topic where I actually have some expertise and something to add to what others have already written about.
PPS - I should say that although I've given Kent a hard time here, I've been for a drink with him in the recent past, and he is actually a very nice guy and also fantastically intelligent.