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Pseudo-regulation: another chance to save the MHRA from looking idiotic

January 26th, 2011 · 19 Comments

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I hate to be forced to return to the world’s most boring delusion, homeopathy. It is boring because the battle to inform people how daft it is has been almost won. Now not a single Bachelors degree in homeopathy appears in UCAS, compared with at least five in 2007. But the battle is not quite won with the UK Government. This post is not so much about homeopathy as about the failures of the Government and the MHRA.

The Medicines and Health Regulatory Authority (MHRA), has just launched yet another consultation and I have felt obliged to waste an entire Sunday writing a response to it, I can’t imagine that any scientist would disagree much with what I have written, but most of them have far better ways to spend their time than bothering about the lunatic fringes of medicine. No doubt most of the responses will come from people who make money from homeopathy, Not just the homeopaths on the High Street, but also the very rich companies like Boiron and Weleda who make enormous profits from selling pills that contain nothing but a bit of sugar.

The documents

The consultation concerns what should be done, about homeopathy in the wake of the scarifying report of the House of Commons Select Committee [get pdf], and the governments response to that report [get pdf].

The MHRA’s request for consultation is here. Download the consultation document. You can download my full response [get pdf], Please write your own response and send it to andreafarmer@mhra.gsi.gov.uk before February 17th. Feel free to plagiarise anything you find here.

Another good response is from Healthwatch, [download pdf]

And an excellent response  by Prof John C. McLachlan [download pdf].

Now I’ll filll in some of the background and outline why I think the MHRA still hasn’t understood.

The Medicines Act 1968 and PLRs

The Medicines Act (1968) was passed in the wake of the thalidomide disaster. It required evidence that medicines work and that they are safe. It was not possible to check all existing medicines by the time the Act was implemented in 1971, so, as a temporary measure, many medicines, including homeopathic stuff, were give a "public licence of right" (PLR). Forty years later they have mostly vanished. But not for homeopathy. The PLR is the licence that allows homeopaths to break all the rules. They still exist.

MHRA cocked it up in 2006

The story starts with the National Regulation Scheme for homeopathic junk that was introduced by the MHRA in 2006. This allowed, for the first time, indications to be put on the labels of the bottles of sugar pills. There were howls of outrage from just about every scientific organisation (the medical establishment was, as usual, more pusillanimous, with some honourable exceptions). The history is related here in the following posts.

The MHRA breaks its founding principle: it is an intellectual disgrace 

The Royal Society speaks out on CAM

Learned Societies speak out against CAM, and the MHRA

The MHRA loses the plot: it allows mislabelling of Arnica gel

House of Lords slams homeopathy and the MHRA

MHRA admits herbal medicines unproven

The Science and Technology Select Committee report

This was an admirable effort, It extracted, with some difficulty, admissions from Boots’ professional standards director that the sold pills while knowing that they didn’t work. It also squeezed out of the then Health Minister, Mike O’Brien an admission that they don’t work, Less surprisingly, the head of the MHRA agreed that they don’t work. So it is unanimous (apart, of course, from those who make money from selling things that don’t work).

If you want to know more about Boots’ Professional standards, take a look at Mis-education at Boots the Chemist, or The Vitamin B scam. Don’t trust Boots, or Boots reaches new level of dishonesty with CoQ10 promotion, to name but a few. The oral sessions of the committee were notable for the squirming evasiveness of most of the answers to simple questions. An account can be found in Comedy gold in parliament and tragedy from Prince of Wales: editorial in British Medical Journal

The Government’s response to the report was mostly as truly pathetic bit of official waffle, like those letters you get when you write to your Member of Parliament. But it did contain one good thing."In order for the public to make informed choices, it is therefore vitally important that the scientific evidence base for homeopathy is clearly explained and available." (though even that statement is attributed to John Beddington, the Government’s Chief Scientific advisor, rather than something the Government thinks essential).

"“The MHRA will review the labelling requirements under the NRS to ensure that these deliver clarity as to the status of products and their composition."

The proposals in the MHRA Consultation document’

There are a couple of good things in the proposals. The MHRA proposes to end PLRs (decades overdue, but nonetheless welcome).

The MHRA proposes to stop ‘regulating’ (ho ho) “Bach Flower Remedies” as medicines (but seems happy to classify them as food Supplements, another weasel description to evade sensible regulation). That’s sensible because they aren’t medicines. Homeopathic pills most certainly aren’t medicines either but the MHRA seems to have difficulty grasping that, and wants to treat them quite differently from “Flower remedies”

More honest labelling was about the only sensible thing recommended by the Government’s response. On this topic the MHRA proposals verge on the laughable

At present the labelling allowed under the NRS includes

“A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of ….”

It is proposed to change this to

“A homeopathic medicinal product licensed only on the basis of safety, quality and use within the homeopathic tradition”

“A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of……”

Spot the difference!

The is utterly inadequate. In fact it verges on the pathetic (and on the dishonest). Here is an extract from my full response.

"Sad to say these proposals to remedy the labelling problem are wholly inadequate. They are almost as deceptive as the originals. These labels don‘t come anywhere near to fulfilling the requirement in the government‘s response which said

In order for the public to make informed choices, it is therefore vitally important that the scientific evidence base for homeopathy is clearly explained and available

Why, oh why, cannot the MHRA bring itself to simply tell the truth? It seems to be so stifled by some perversion of political correctness that it is unable to do what it must know is right.

Nothing indicates more clearly the ludicrous state of the NRS than the label approved for Arnica 30C pills.

The approved label says

"ACTIVE INGREDIENT
Each pill contains 30C Arnica Montana
Also contains: lactose and sucrose"

The MHRA must decide whether or not it believes Avogadro‘s number or not.

How many people in the general public realise the ―Each pill contains 30C Arnica Montana‖ means that the ―pills contain no Arnica whatsoever‖? The very mention of the words ―active ingredient‖ will suggest to most people that there is an active ingredient when there is not. This wording alone is both dishonest and deceptive.

The rest of the approved label consists largely of make-believe too.

"If you are pregnant or breastfeeding consult your doctor before use"

What is your doctor meant to advise you about the dangers of taking a few mg of sugar when you are pregnant?

"If you take too much of the product (overdose) speak to a doctor / pharmacist and take this label with you,."

Unless the MHRA has disavowed Avogadro‘s number, an overdose is impossible. To allow a label like this makes the MHRA a laughing stock

http://www.dcscience.net/wp-admin/edit-tags.php?taxonomy=category

Labels should tell the truth in plain language. For example they should say

This product contains no Arnica

There is no evidence that it works for any condition, other than as a placebo

Some comments on regulation of magic medicine

Governments like to regulate things. They should have regulated the banks a bit more. The problem arises when you try to regulate things that are myths. Like homeopathy.

Andy Lewis has recently written a superb account of the problems on his Quackometer blog, When the Regulator Believes in Fairies, Who Protects the Public?

The government appears to believe that "training" will solve all the problems. Training people to believe things that aren’t true can never solve problems. On the contrary, it creates problems. Organisations like the Complementary and Natural Health Care Council (CNHC)do nothing to protect the public, They endanger the public (see Why the CNHC can’t succeed). Their excuse for rejecting complaints that members were making false claims was not to deny that the claims were false, but to say that it didn’t matter because that is what they had been trained to say. That is make-believe regulation.

Follow-up

.This is Andy Lewis’s version of an honest label. It looks quite accurate to me.

quackometer

27 January 2011

News today makes one despair of the morality of governments. Remember those obviously fraudulent bomb detectors, no more than a dowsing rod? Although they are now the subject of a fraud investigation, they are still being sold. The government has banned their export to Iraq and Afghanistan, but NOT to anywhere else, This suggests not only that the government is (or at least was) quite happy to believe in dowsing. It also implies that even when they realise that it’s fraud they take the view that that business is far more important than even the most basic morality. No doubt they will allow fraudulent labelling of medicines in order to protect the homeopathic industry

Does politics have to be quite so disgusting?

28 January 2011. An excellent post on a similar topic is that referred to in a comment below. The MHRA and the non-regulation of homeopathy explains the European background better that I have done.

11 February 2011. Here is a characteristically beautiful response to the consultation by Prof John C. McLachlan, who has allowed me to post it here [download pdf].

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Tags: Boots · CNHC · homeopathy · MHRA · regulation

19 responses so far ↓

  • 1 pberry // Jan 26, 2011 at 14:23

    When the regulatory body is toothless or apathetic, what realistic course of action is there?

    (To that end, I admire your continued efforts, though it’s fair to say it’s the scientific equivalent of shooting fish in a barrel.)

  • 2 Tweets that mention Pseudo-regulation: another chance to save the MHRA from looking idiotic -- Topsy.com // Jan 26, 2011 at 14:28

    […] This post was mentioned on Twitter by Crispian Jago, Blue Wode, annabel bentley, annabel bentley and others. annabel bentley said: Pseudo-regulation @david_colquhoun on: "another chance to save the MHRA frm looking idiotic" http://bit.ly/eRo2K1 […]

  • 3 lecanardnoir // Jan 26, 2011 at 16:21

    I would suggest to the MHRA that if they receive responses from homeopaths suggesting that they are happy with the proposed form of words to be put on labels, then that is a very good indication that they have gotit wrong.

  • 4 warhelmet // Jan 26, 2011 at 17:57

    I think that this is edge embroidery. It really doesn’t address one of the most awkward regulatory issues. A high proportion of homeopathic medicines on the UK market are unlicensed medicines. Unlicensed medicines are strictly controlled. Yet they are illegally sold every day by the homeopathic industry. (I confess to have an intimate knowledge of the subject.)

    Tackling PLRs asks the question of whether the MHRA have any real interest in regulation or just want to be seen to go through the motions.

  • 5 David Colquhoun // Jan 27, 2011 at 00:07

    @lecanardnoir
    Good idea. I’ve heard the homeopaths are quite happy with the tiny changes. The problem is that the MHRA may well not interpret that the way that you and I do.

    @warhelmet
    The easiest way out for the MHRA would surely have been to treat homeopath like “Bach Flower remedies” and stop treating them as medicines (because they aren’t).
    My proposal is that they should do that, but at the same time ensure that existing consumer protection laws are enforced (which they are not at present) so that anyone making outrageous claims could be prosecuted.

  • 6 enSKog // Jan 27, 2011 at 00:27

    As well as deleting the ‘medicinal’ from the proposed labelling I would suggest that the word ‘quality’ also needs to go.
    How do they measure the quality of these products. Do they check to make sure there really is no active ingredient present? What is the accuracy of the dilution – is 30C anywhere between 29.5 and 30.5? (As if it would make any difference!)

  • 7 skepp // Jan 28, 2011 at 03:25

    Don’t shoot at the UK administration or other national governments. They have to accept shaken water as medication. The culprit is the European parliament that has voted special laws baptising homeopathy as medication. No need for proof of efficacy, not requirement to advertise the content in verifiable units, they can mention a medical indication if was mentioned in a homeopathic publication.
    I have witten a more detailed article on it that can be found on the website of the European skeptics http://www.ecso.org/
    Please use it as you like and do not hesitate to write your national EP members. I can provide their adresses and emails if you ask me. Write to skeppATtelenet.be

  • 8 David Colquhoun // Jan 28, 2011 at 11:47

    @skepp
    Thanks very much for that valuable link. Thanks too for the list of MEPs [download the excel file]

    Stupid though the European rules are, I really don’t think that either the UK Government or the MHRA can escape responsibility as easily as you suggest. There is some flexibility in the way the rules are implemented. We have a National Rules scheme, after all. I’m not sure that we were forced to make it as duplicitous as it is.

    As a minimum the government and the MHRA are free to say “we know this is junk but we are forced to do it”. That is not what they say, and that is a disgrace.

  • 9 tomc // Feb 11, 2011 at 21:09

    I know nothing about 30C Arnica Montana or arnica but I do know about consumer and advertising law. If your statement…

    “How many people in the general public realise the ―Each pill contains 30C Arnica Montana‖ means that the ―pills contain no Arnica whatsoever‖?

    … is correct then you are equally correct – the labelling is deceptive and misleading. Someone should perhaps consider filing a complaint with the ASA (www.asa.org.uk). If (and it’s hard to imagine it wouldn’t be), the complaint was upheld, would the MHRA not have to taken even more notice of the blindingly obvious… Just a thought. Peace.

  • 10 David Colquhoun // Feb 11, 2011 at 21:52

    @tomc
    The ASA has a good record in judging such complaints, but it can do next to nothing about it.

    It is the job of Trading Standards Officers to enforce the Consumer Protection Regulations 2008, but they consistently fail to do their statutory duty. See. for example, The Esperanza scandal. Office of Trading Standards useless, and
    Most alternative medicine is illegal

  • 11 zeno // Feb 16, 2011 at 19:34

    @tomc

    Yes, it is misleading, but the ASA won’t touch it because the MHRA allow it. CAP Code:

    12.11
    Medicines must have a licence from the MHRA before they are marketed. Marketing communications for medicines must conform with the licence and the product’s summary of product characteristics. For the avoidance of doubt, by conforming with the product’s indicated use, a marketing communication would not breach rule 12.2.

  • 12 David Colquhoun // Feb 16, 2011 at 23:58

    @zeno
    Thanks for pointing out that loophole.
    But surely the Consumer Protection regulations (2008) and the cancer act (1939) still stand and could, in principle be used. See Most alternative medicine is illegal.

    The biggest gap in regulation is the fact that the Trading Standards people are failing entirely in their statutory duty to enforce these rather good laws.

  • 13 zeno // Feb 17, 2011 at 01:41

    I can understand why the ASA won’t get involved with the advertising of proper medicines that have been licenced by the MHRA: the MHRA are the experts on them so they should be regulating advertising.

    However, this was yet another side-effect of the MHRA giving quack products unearned and undeserved legitimacy.

  • 14 In case of overdose, consult a lifeguard | Ben Goldacre World Bad News : World Bad News // Feb 19, 2011 at 11:27

    […] on and do anyway. At midnight, a Medicines and Healthcare Regulatory Authority (MRHA) sealed a consultation on how it should tag homeopathy sugarine pills. You might not consider this is a formidable task, […]

  • 15 A ciência e a homeopatia | 10:23 Portugal // Feb 20, 2011 at 18:26

    […] passada a MHRA -Medicines and Healthcare produts Regulatory Agency – no Reino Unido recebeu propostas para alterar as etiquetas dos produtos homeopáticos: “Para o público poder tomar decisões […]

  • 16 Checking homeopathy – fat chance | Not ranting – honestly // Feb 22, 2011 at 10:17

    […] so I won’t re-hash it again. If you aren’t , you can get some of the background at David Colquhoun’s blog. Or you can read an editorial I wrote for Physiology News about this back in […]

  • 17 Moochie // Feb 27, 2011 at 16:45

    I think any mention of “placebo” might confuse people more. Is there a clear and succinct definition of “placebo”? eg, “This medicine is nonsense. If nonsense makes you feel better, then good.”

  • 18 David Colquhoun // Feb 27, 2011 at 18:19

    @Moochie
    I don’t think that there is any difficulty in defining a placebo, specially when pills are involved. But there is sometimes a problem in putting into practice.

    In the case of something totally barmy like homeopathy, the placebo is easy to devise, but since it is identical with the treatment, it’s not worth spending any more time on it.

    Herbal medicine is different. There are real ingredients. But the few that have been tested have almost all failed. It has become a hobby now to ask every herbalist to tell me the single herbal treatment for which the best evidence of efficacy exists. I still have not had a single reply. Herbalists don’t seem to give a damn about evidence. They just want to sell you a bottle.

  • 19 Why does the MHRA refuse to label herbal products honestly? Kent Woods and Richard Woodfield tell me. // Apr 1, 2011 at 11:42

    […] in the labels that have been allowed by the MHRA for homeopathic pills. That has been discussed in Pseudo-regulation: another chance to save the MHRA from looking idiotic . The matter is not yet decided, but on past performance, I’m pessimistic about whether the […]

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