Wednesday, July 1, 2009

MHRA publish public assessment of homeopathic arnica, admit it does nothing, but license it anyway

Just off so no time to blog this properly, but back in May I blogged about the Medicines and Healthcare Products Regulatory Agency giving their blessing to Nelson's selling homeopathic arnica with therapeutic indications.

The full report is now published and can be found here.

A few choice quotes for your discussion:

The homeopathic medicinal product consists of white to off-white spherical pillules
for oral administration, containing 30c (GHP) Arnica montana. It is used for the
symptomatic relief of sprains, muscular aches and bruising and swelling after
contusions. Two pillules should be taken every 2 hours for the first six doses, then
four times daily until symptoms improve for up to a maximum of 7 days.


The excipients used to manufacture the homeopathic medicinal product are lactose,
sucrose and purified water.
Oh, no arnica then?
This bit is utterly laughable:
Published scientific literature review
The applicant has provided a bibliographic reference documenting a summary of
clinical trials using arnica in homeopathic dilutions. The summary refers to studies
where Arnica had been administered in a number of clinical conditions.
The applicant has also provided further details of eleven published clinical studies
investigating the clinical effects of arnica. The studies were performed under
randomised, double blind conditions and were carried out to investigate the post
operative clinical actions of arnica, such as pain relief and bruising.
The results of the clinical trials and studies provided were not conclusive in
establishing the clinical effects of arnica but indicated that there may be a trend
towards demonstrating some beneficial effects of arnica in some situations.

I'll be contacting the MHRA as they seem to have omitted an important safety concern - how do I know that what is in the pack is what is on the label? Both you, I, MHRA and Nelson's know it is impossible to tell.

20 comments:

  1. All of it is 'utterly laughable' and a lot more besides.

    I await with interest for their reply.

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  2. That's the very question that's been going through my mind - how do you know what you're getting?

    If I buy Ibuprofen pills and find they have Paracetamol in them instead, then I can lodge a formal complaint and the chances are there will be a mass withdrawal of the product and maybe a lawsuit and compensation.

    But if I buy any homeopathic product and suffer any ill-effects then, providing the label is "correct", there's no way to tell if the wrong pills were given to me.

    It seems the only way a truly homeopathic product can be "wrong" is if it actually does contain something beyond the base solvents or sugar pill.

    It would be interesting to see what the response is if someone were to return some pills complaining they were the wrong product.

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  3. I'm a bit brain-fuddled at the m oment but reading through the document I find this:

    The applicant has applied to authorise a 30c potency of Arnica, diluted to 10**30

    (that's 10 to the power of 30 - can't use "sup" tag here)

    Wouldn't a 30C be 10 to the power of 60 since each dilution is x100, not x10?

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  4. Andy wrote, "Wouldn't a 30C be 10 to the power of 60 since each dilution is x100, not x10?"

    Yes, it would.

    Perhaps they thought that saying it is a 10 to the power 60 dilution would look silly. ;)

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  5. I suppose precision is irrelevant once there's no ingredient left.

    24C, 30C, 60C, 200C - all the same really.

    It's also interesting to note that dilutions above 24X are automatically assumed to be safe. It's almost like they know it's got nothing in it :)

    I wonder on what grounds they determine it isn't fraud?

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  6. In my view the label is illegal under the Consumer Protetction Unfair Trading regulations (May 2008). Unfortunately Trading Standards officers seem remarkably reluctant to enforce these laws.

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  7. I entirely agree, David, that it has to be illegal. They are misleading and deliberately designed to mislead the public.

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  8. Andy said, "It's also interesting to note that dilutions above 24X are automatically assumed to be safe. It's almost like they know it's got nothing in it"

    Under the special scheme introduced for homoeopathy in the 90s (the one that didn't allow "therapeutic indications") one of the criteria was that the remedy be sufficiently dilute to guarantee safety. In effect this meant sufficiently dilute to guarantee it didn't do anything at all. I'm not sure if there is a similar provision in the new scheme.

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  9. Thanks for your comments everyone.

    I have written the following complaint to the MHRA - I'll let you know the response:

    Dear Sir/Madam,

    Homeopathic seller Nelson's recently applied for and obtained a homeopathic marketing authorisation for the homeopathic
    medicinal product Arnicare Arnica 30c pillules (homeopathic marketing authorisation number: NR 01175/0181).

    I have two issues with this report and I would request that they are addressed seperately and given seperate complaint references

    1. The public assessment report was recently posted on the MHRA website, containing the line:

    "The applicant has applied to authorise a 30c potency of Arnica, diluted to 10^30 and currently holds a homeopathic registration certificate for dilutions of Arnica 4x to 200c inclusive for oral use, fulfilling criteria (b) and (c) above."

    I understand this to be incorrect, as a 30c potency is a 10^60 dilution and not 10^30. I am surprised that this basic mistake was not picked up by Nelsons or the medical writers at MHRA, as the dilution level is an important part of the homeopathic belief system.

    Please advise your course of remedial action.

    2. The amount of work involved in diluting materials to this length is non-trivial, and I am interested how the MHRA police this in order to ensure that homeopathic companies are indeed diluting to the level stated on the packet. I am not aware of a method which describes how two homeopathic pillules, e.g. one of 15c (10^30 dilution) and 30c (10^60 dilution) can be distinguished. Please advise how you will ensure that Nelson's are indeed diluting the mother tincture to the level described, so that you can be certain that the product inside the packaging matches the description on the outside of the packet.

    I look forward to your responses on these two seperate complaints.

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  10. Could you explain your objection about not being able to tell whats in it further? I agree with your general objections to homeopathy, but I simply don't understand this one, and would appreciate you fleshing it out.

    Andy writes: "If I buy Ibuprofen pills and find they have Paracetamol in them instead [...]"

    How would you find that out?

    One way would presumably be with a chem lab. But is it the pharmaceutical company's job to describe the process you would need to follow to test their preparations? If not, why should a homepath be required to provide equivalent protocols? (Perhaps it is required; I don't know the regulations.)

    Another way would be to observe the manufacturing processes, but that would technique apply equally to homeopathic preparations.

    A third way would be to observe the effect of the chemicals on people or animals. (e.g. your Ibuprofen triggers an allergic response from someone allergic to paracetemol - if such an allergy exists). Homeopathy wins here by never triggering a different response no matter what the preparation.

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  11. Hi Julian,

    I would not want to rely on the pharmaceutical companies telling me what's in a drug. It's too easy to take out the expensive bits and put in cheap bits.

    One of the angles of the MHRA is ensuring what is supposed to be in a certain medication. Everything is agreed to beforehand - the packaging, the script, the information, the product, the manufacturing process - everything.

    Hence, MHRA can grab some of the product at a later stage and check to make sure that the drug company is held to account.

    For these homeopathic sugar pills, there is no way of telling the difference between the virgin sugar pill, a 30c, 60c, 100c or whatever. So how do we know that Nelson's have bothered to do the succussion? Couldn't they just say "No-one can tell the difference, just chuck in a load of sugar pills"?

    Well, yes they coould, because apart from taking Nelson's word for it, there is no way of distinguishing them.

    Can you imagine saying to Pfizer - "Do you promise to put in active ingredient in your viagra and not just chalkdust?" and then not being able to check? Obviously in this case there would be em.. physical signs but with homeopathy, the vast majority of evidence points to it being indistinuishable from placebo, so no dice.

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  12. It's an odd discussion for me, because (a) I have no experience with the responsibilities of the MHRA and (b) I have to think about this under two scenarios:

    In the real world, where homeopathic sugar pills = sugar pills, there is no issue. Test the pills contain sugar and you are done. Nelson's can skip the succussion with no effect on their patients. There's a lot to be upset about with homeopathic manufacturers, but this seems an odd thing to get caught up about.

    In a fantasy land, where homeopathy works and unicorns graze in fields, there's an issue. If someone claims that 30C unicorn horn has an effect like Viagra, then it makes sense to be sure that they are using unicorn horn rather than the rather cheaper rhinoceros horn. However, I would have thought the onus would be on the regulatory authority, rather than the manufacturer, to come up with a test. Are Pfizer required to produce protocols for measuring the sildenafil content in their blue pills, or is that the responsibility of the MHRA?

    Further, if it is the responsibility of the MHRA, then are they at liberty to deny a license merely because they don't have the expertise or equipment to measure the memory of water (which we are taking as a given in this scenario)?

    I guess I am still trying to understand your motivation to chase this issue down given that I can't see how it makes a difference in the real or the fantasy world. If there is a way in which this issue will effectively trap the MHRA into doing the right thing, then I applaud your diligence and please keep up the good fight - however, in my ignorance of the MHRA, I can't see how that can eventuate.

    p.s. If this comment gets past your spam filters, despite the drug mentions, I will be most impressed.

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  13. There's a lot to be upset about with homeopathic manufacturers, but this seems an odd thing to get caught up about.

    Oh, I don;t think so. They are asking to be treated as 'licensed drug manufacturers'. The MHRA have crumbled and given them a cloak of respectability that they do not deserve. The argument in this case is "OK, if they want to be treated like a drug company, then we'll treat them like adrug company" and demand the same paper trail as any other drug manufacturer.

    In this case, they are unable to do it - noone can tell the difference between two of their products, yet they are allowed to sell them as 'drugs'. That to me is a huge problem for the MHRA. And an angle I'll keep trying.

    See above - DC is trying to contact the trading standards alon similar lines.

    Are Pfizer required to produce protocols for measuring the sildenafil content in their blue pills, or is that the responsibility of the MHRA?

    My understanding is Pfizer - although the full details have to be given to the MHRA who will then do checks as necessary (although I must admit, I don't know exactly the protocol).

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  14. Ah, it surprises me that the onus is on the manufacturer, but if Pfizer has to provide the process, then, yes, so should the homeopaths.

    Go for it!

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  15. Julian, let's look at it this way. Imagine that the MHRA - or anyone - decides to run a test to see what's in various "medications". I imagine the UK have consumer groups or investigative journalists, like we do in Oz, that do this sort of thing occasionally.

    So they test a bunch of products and find that the homeopaths have seemingly put the same thing in every bottle. This news is trumpeted, or should be, across the headlines.

    How would the manufacturer properly respond to the claim and prove that they are not cheating? Merely demonstrating their process isn't enough - or shouldn't be.

    Theoretically they should recall the affected products until they can discover what went wrong.

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  16. Andy,

    This news is trumpeted, or should be, across the headlines.

    Errr... my reaction here is to simply refer to reality. To the best of our chemical knowledge, homeopaths DO put the same water into every bottle. It DOESN'T make headlines.

    How would the manufacturer properly respond to the claim [...] ?

    With hand-waving, referral to memory of water and use of the word "quantum" a lot, or at least that is what I have seen.

    My coda to this story: I found out last night that my housemate (coincidentally, I'm also in Oz!) spent $AU120 on herbal remedies, after $AU80 worth of advice from a naturopath. The drugs come in a bottle that is labelled with the patient's name and dosage instructions, but has absolutely no mention of the ingredients, beyond "Herbal Solution". No risk of a recall there!

    My housemate reported feeling buzzed and happy after the herbs. No idea if it was placebo, caffeine, or something else.

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  17. Actually, I have a new coda to this story.

    Last night, I met a woman at a party who organises clinical trials for a pharmaceutical company here in Australia

    She confirmed that the pharmaceutical companies develop the protocols to test the drug contents. Her pharmaceutical company perform regular tests on random samples of drugs that they import. They share the protocols with the TGA (Therapeutic Goods Administration) to allow them to perform the tests, but the TGA don't have the money to actually perform them regularly.

    In Australia, homeopathic remedies are not TGA-registered, and therefore don't need to comply to these rules.

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  18. To get a herbal/homeopathic licence you have to go through the same quality and safety assessment protocols based on EU Common Techincal Document Formats (CDTs) as a pharmaceutical drug does.i.e 6months of batch analysis on 10% of your batch (say 100,100 units) chemotography, assay testing carried out by a Qualified Person in a MHRA recongised lab, it is very complex and no mean feat to get one of these licenses. These stringent tests prove the products stability, that it is free from any toxins, meets Good Manufacturing Guidelines (GMP) etc. The MHRA product assessment summaries are narrowed down from say a 300 page application to the much more readable public version the MHRA produces at the end. It costs a company between £50-£150k to do this, as a result many homeopathic and herbal product businesses have gone out of business or will do be post April 2011, yippee more UK unemployed! Do I hear you shout hurray!!? Your comments are based on analysis of a summary and no concept of the regulatory licencing marathon that is registering a homeopathic or herbal product. I can assure you that the product by the time it is licensed is completely safe. These products do not have to legally prove efficacy, just safety and quality. This is most upsetting, because then members of the public go out and buy them and some of them find them effective god dammit, they should not have the right to buy the things you people don't approve of them buying!! should they? If only you guys ruled the world eh.

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  19. HI Avena,

    What is chemotography?

    T

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    Replies
    1. I think "chromatography" is likely what Avena meant; although, chemotography is actually a sub-type of chromotography (chemotype chromatography) used in oncological pharmacology for chemogenomic data visualization.

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