The Science and Technology Select Committee have published two new documents submitted by the MHRA as part of their homeopathy 'evidence check'; a public consultation from 2005 which the MHRA used to argue that there was "widespread support for the introduction of national rules for the authorisation of homeopathic medicinal products"; and a document describing how labels for the homeopathic remedy 'Arnica 30C' was tested.
Parts of the MHRA's evidence are so bizarre that I'm almost tempted to stop writing this post, in case it turns out that I've actually just imagined them in some weird, fucked-up dream I had last night.
I'll start with the labels first. Arnica 30C was the first and only homeopathic remedy licensed by the MHRA, and in achieving this it had to pass stringent guidelines on labels. In particular, labels had to clearly convey to the public what was in the 'medicine'. In order to test this, the MHRA employ focus groups, and ask them questions.
The full list of questions can be found here, but two are worth pointing out:
5. What does the label say is the active ingredient in this medicine?
8. This medicine contains Arnica Montana 30C. What are the other ingredients in this medicine?
What the what now?!
The medicine is homeopathy, diluted to 30C, and therefore there is no active ingredient in it. An accurate label would look something like the following:
Question 5 is easy to answer correctly - the label says the active ingredient is Arnica 3OC. It isn't, but incredibly the MHRA test doesn't check that, it just checks that people can read the words 'Arnica 30C' on a label. You could have an MHRA focus group consisting entirely of three-year-old toddlers and their pet gerbils, and Arnica could still pass what the MHRA laughably refer to as a 'test'.
If that's bad, question 8 is a farce: "This medicine contains Arnica Montana 30C." The MHRA's label test is predicated on the idea that homeopathic remedies have mystical ingredients that violate the laws of physics. By this nonsensical approach, I could sell bottles of air claiming that there was mystic energy inside, label 'mystic energy' as the active ingredient, and the MHRA would apparently find this perfectly acceptable.
It's hard to follow up something as farcical as the label test, but the 2005 consultation document gives it a good go. It was used by the MHRA to argue that homeopathy had significant support, but until today has never been published. Phil Willis, the Select Committee Chairman, neatly summed it up during MHRA head Professor Kent Woods' appearance at the committee hearings as follows:
"Out of the 32 responses you got two were not publicly available because of commercial sensitivity; one was regarding a totally different consultation on herbal medicines; five were acknowledgements which simply said "No comment"; three were concerned with the inclusion of anthroposophic medicines; one was from the Royal College of Radiologists in support but they mistook what the consultation was about herbal medicine; and of the remaining 20 that were concerned with the licensing of homeopathic products the members of the public referred to are two vets and the editor of a US website who all strongly objected to the proposals. The British Veterinary Association, the Royal College of General Practitioners, the Royal College of Physicians, and the Royal College of Obstetricians and Gynaecologists all opposed homeopathy, yet your recommendation to the Minister was there was widespread support for the introduction of National Rules"
Woods' attempt to protest this went badly:
Professor Woods: But you mentioned to me in the list a number of active homeopathic organisations whom I am quite sure were supportive of the National Rule Scheme.
Q222 Chairman: Of course they would be.Professor Woods: Of course, but the consultation covered the whole spectrum.
Q223 Chairman: It is like saying "Do jockeys like horse racing?"
Willis went on to ask whether Woods found "it a little strange that you seem to have rejected [the arguments] of anyone who was opposed?" The release of the consultation shows the rejections, and the strangeness that Willis refers to is immediately apparent.
For example, the Royal College of Physicians made the point that homeopathy is unsupported by evidence, and that this should be made clear on product labels:
"RCP think that factually correct statements in the product information or labelling regarding traditional use should be compulsory qualified by statement to be agreed with regulator along the lines of 'but there is not evidence that it is more effective than dummy treatment'."
The MHRA responded with the following (my bold):
"The suggestion comments regarding making users aware that there is no evidence for the use of homeopathic products has been noted. 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. Consequently the suggested statement would not be permitted."
Sorry, what? Are the MHRA seriously saying that there is some sort of ban on information like this being included on homeopathic labels? I plan to investigate this further when I have time (if anyone else does, please twitter me at @mjrobbins or leave a comment and I'll link to you), but if true this would be incredible.
The British Veterinary Association gave a very strongly-worded response, virtually equating homeopathy with animal abuse:
No genuine “provings” of homeopathic remedies have ever successfully been performed in animals. Wild extrapolation of disproven human therapeutic modality to animals is therefore an offence to animal welfare.
The MHRA's response was one line: "The National Rules scheme to be set up is intended for Human use." Well, yes, but the exact same criticism surely applies to humans? The point that the 'medicines' licensed are "wild extrapolation of disproven human therapeutic modality" are simply ignored.
You can read the rest of the consultation yourself, but one final example comed from the Royal College of General Practitioners who note that:
...a more scientific alternative would have been to withdraw all PLRs with indications unless there was proven evidence of effectiveness.
The MHRA response notes that "...information must be provided in order to demonstrate the pharmaceutical quality and safety of the products." But how is this possible? Arnica 30C is not a pharmaceutical product, it contains no active ingredients and it has no demonstrable clinical effect.
But none of this seems to matter to the MHRA - an organization that simply don't seem to get it. Their approach to science and evidence borders on the wilfully obtuse, and the tests they apply to licensing applications are so basic and obviously flawed that one wonders what exactly you would have to do to fail them.
Normally I'd try to finish on a snappy conclusion, but I'm lost for words. Fortunately, in my role publicizing the 10:23 campaign, I have a rare opportunity to bring homeopathy to the attention of the national media at the end of this month. I plan to put some strong questions to the MHRA over the weekend. Feel free to do the same over at their contact page, and let me know how you get on.
- - - - - - - - - - - - - - -
The 10:23 Campaign goes public this weekend. Please visit the website and sign up to join our protest against homeopathy.
http://layscience.net/trackback/895
Apart from the medical colleges, the scientific learned societies were also opposed to the change in labelling. See Prof David Colquhoun's blog for a summary. To take a typical example, here is the Physiological Society:
‘The Physiological Society is concerned with the scientific investigation of how the body works … It is our view that "alternative medicine" has, with very few exceptions, no scientific foundation, either empirical or theoretical. As an extreme example, many homeopathic medicines contain no molecules of their ingredient, so they can have no effect (beyond that of a placebo). To claim otherwise it would be necessary to abandon the entire molecular basis of chemistry. The Society believes that any claim made for a medicine must be based on evidence, and that it is a duty of the regulatory authorities to ensure that this is done.’
This is simultaneously very important and worrying and also rather amusing and bizarre ;)
The label test sounds more like the last phase of a series of tests (where the first tests have been missed perhaps).
For example, whenever a new document is written at work (eg about a new treatment, test or something to do with healthcare) it is written by medically or scientifically competent people, then proofread by someone else with med/sci background. It's also checked so that it is consistent with our other documents and our 'message'. After that it is sent to the publishing teams who proofread it in a different way - they look for spelling mistakes, weed out phrases or terms that we don't use, and make sure it's in tune with our 'tone'. Presumably this is a method that lots of other publishers use.
What may be missing in this case is the sci / med testing, what we seem to have here is an acceptance that the word arnica is spelled correctly ;) Well.. not much more than that!
But, Go Physiological Society!
Anyway I've done a teeny bit of market research, for a 'big pharma' and these were pretty much the same questions the interviewer asked me - it was solely to ensure that a patient information leaflet was understandable, rather than packet labelling, but I expect they tested that too. I'd have to assume they did separate work in demonstrating that the drug actually worked though!
Do these products (the ones with lactose) highlight that they're not suitable for people with lactose intolerance? Or is there so little lactose in them too I wonder...
Jo
Astonishing, a real insight into how homeo-woos reject evidence that is not aligned with their ideology - and moreover, further evidence that the SciTech committee is one of the most important bodies in the battle against pseudo-scientific nonsense.
Right. Let's see. Articles 68 and 69 of this Directive: 2001/83/EC (PDF) seem relevant.
This only applies to homeopathic remedies that are "subject to a special, simplified registration procedure." Among the conditions imposed on remedies registered using the special, simplified procedure are that the remedies are sufficiently dilute and that "no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto." (The only other condition is that they are administered orally or externally.)
So for those dilute homeopathic remedies that do not have medicinal claims, it really does look as if the Directive forbids labelling such remedies with additional details to those provided in Article 69.
I's almost like the MHRA are in the pocket of Alt-Pharma.
The MHRA were, I think, persuaded (by a combination of lobbying from the public, the supplement industry, AltMed enthusiasts within medicine, Clarence House, and elements of the Govt, at a guess), that "natural remedies" in general was largely a consumer choice issue. This was certainly the Blessed Tony (Blair's) take on homeopathy. When the learned societies were lobbying against the rule chances it was quite clear the Govt didn't see what they/we were getting exercised about. To paraphrase the general message:
"People want this stuff, it's been around ages, if it doesn't poison them then what's the harm? And it's creating British jobs. You scientists should stick to lobbying on big stuff like climate change and stem cell research"
The idea that by legitimising nonsense there you opened the door to it in all sorts of other ways was quite lost on the politicians.
Another difficulty was that the changes let the Alties make clear medical claims (with only the ludicrous and feeble caveat of having to say "traditional use") and the politicos got the MHRA to sign all this off, thereby traducing the organisation and forcing it to indulge in the ridiculous DoubleThink of "You have to have evidence to make claims for real medicines but NOT to make claims for herbals etc".
One does wonder how hard the MHRA tried to resist this. I suspect they were probably told:
"Look, shouldn't you be doing the safety assessment? You are the "things-taken-as-medicine safety-people", after all"
(Appeal to "Professionalism" plus a bit of flattery)
and
"It'll add to your organisation's portfolio... plus if you don't sign on it'll happen anyway"
(Carrot and stick)
I think the key to how homeopathic remedies are being dealt with by legislation is that this is something determined by EC member states. As homeopathy, for example, is popular in France and Germany there probably will be businesses and politicians interested in maintaining the homeopathy trade in those countries. Anyway, EU Directives are meant to harmonise rules in a way that protects the public, but does not hinder trade. From 2001/83:
A lot of it's about removing hindrances which affect "the functioning of the internal market." [See points (2) to (6) of the preamble to 2001/83.] PDF link.
If that's so then the rules are appallingly drafted.
I personally don't see why the label shouldn't say:
"This product has traditionally been used in herbal medicine [or whatever] for X, and has be shown to be safe. However, there is no modern scientific or medical evidence that supports its effectiveness"
This is, in effect, what Mrs Dr Aust (as a practicing medic) tells her patients who come enquiring about the Black Bishbosh root that the neighbour told them helped with their hot flushes, or whatever.
Anyway, if the law precludes that, then the law is wrong-headed. Such a wording would not, IMHO,
"...hinder the development.. of the trade in medicinal products".
In fact, it would arguably encourage this development. Any company who could produce a believable clinical trial to support their product would be able to say so on the label and thereby gain an advantage in the marketplace - so there would be a real incentive to do proper trials.
I'd be interested in the answer to Q.6. 'If you have missed a dose of this medicine, what does the label tell you to do?'
What on earth do you do if you've taken less than you should of a remedy with nothing in it in the first place?
"What on earth do you do if you've taken less than you should of a remedy with nothing in it in the first place?"
Call your homeopath inmediately: is a clear case of overdosis ;-)
I'm not surprised and I think James is right. EU directives are more important than any MHRA public consultation.
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I wonder if Article 69 was intended to stop companies making claims on the packaging?
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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), 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 during the use of the medicinal product. 2. Notwithstanding paragraph 1, Member States may require the use of certain types of labelling in order to show: the price of the medicinal product, the conditions for refunds by social security bodies.
(my bold)
Doesn't this line state that the packaging must have this phrase on it? And doesn't that phrase essentially mean - this is woo, it can't treat anything - or have i got the wrong end of the stick.
The wording does suggest that phrase should appear. The problem is that the phrase is in rather technical language. Think of the warnings on packets of cigarettes and the ways they have been progressively re-worded over the years to make the meaning more obvious.
One could, for instance, read the phrase:
"homeopathic medicinal product without approved therapeutic indications"
- as meaning:
"There is no one particular illness which this is especially good for"
- which is rather different to
"This has not been shown to work for anything at all, including what you are being told by the packaging it is good for"
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