The MHRA and their Double Failure over Homeopathy

nelsons The Medicines and Healthcare products Regulatory Agency (MHRA) have been heavily criticised in recent years for abandoning their core mission by allowing homeopathic sugar pills to contain statements about what symptoms and illnesses they can be used for without having to provide evidence that this is true.

The MHRA mission and values:

Mission
The MHRA’s mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe.

Values
In pursuing our mission we will strive to act with:

  • integrity;
  • openness;
  • courtesy;
  • responsiveness;
  • timeliness;
  • professionalism;
  • impartiality; and
  • consistency.

The MHRA allow sellers to submit evidence from homeopathic ‘provings’ as evidence. A proving is where a homeopath takes a new type of homeopathic pill to see what symptoms it generates. Homeopaths believe ‘like cures like’, so an onion, which makes your eyes stream, can cure hayfever – allegedly. However, homeopathic pills have been so diluted that no ingredients actually remain. What homeopaths ‘prove’ is plain sugar pills – any symptoms they note are either coincidental or imaginary. This is the first failure of the MHRA to allow such nonsense methods to act as a guide to efficacy.

In order for a homeopathic pharmacy to make claims, they must submit the evidence from their provings. So, far few submissions have been made. And yet, homeopathic pharmacists continue to sell many sugar pills, with indications, with no license and apparently with impunity. Is the MHRA even failing to uphold its own rules?

I tested this out.

Over a year ago I was invited to speak at London’s Skeptics in the Pub. I chose to speak about the dilemmas of regulating quackery. As part of my preparation, I visited London’s Nelson’s Homeopathic Pharmacy just off Oxford Street. I went in and said I needed something for an upset stomach and that I had diarrhoea. “Do you have anything like Imodium?” I was told that the stuff they has would not just ‘suppress my symptoms’ but get to the bottom of my problem – so to speak.

I was handed a little green container of white sugar pills labelled ‘Traveller’s Diarrhoea’. The full label read:

TRAVELLER’S DIARRHOEA

RELIEVES SYMPTOMS OF DIARRHOEA & VOMITING DUE TO

CONSUMPTION OF UNWASHED FRUITS, VEGETABLES, BAD MEAT

OR FISH. DOSAGE. TAKE 2 TABLETS EVERY HOUR UNTIL BETTER

ARSENICUM 30/PODOPHYLUM 30/PYROGEN 6/CARBO VEG 30/NUX

VOMICA 30

EXP 12/12 KEEP OUT OF CHILDRENS REACH

NELSON’S HOMEOPATHIC PHARMACY

73 DUKE STREET, LONDON W1K 5BY 020 7629 3118 P

The number 30 is significant because it means the ingredients have been diluted to 1 part in 10 to the power of 60. (that is 30 sequential dilutions of 1 part in 100). In other words – the pills I got were just plain sugar pills with no active ingredients.

Now, remember – like cures like. So being actually healthy at the time, if I had taken one of these pills I would have ‘proved’ the pill and developed the symptoms. Not wanting to do a crude experiment of n=1, during my talk at Skeptics in the Pub I handed them out to the crowd so that dozens of brave and selfless sceptics had the chance to develop a rather uncomfortable journey home.

We downed our pills, and thankfully, due to science, we all remained rather intact and the pub landlord did not have to clear up a rather horrible mess.

On the 28th of March 2008, I submitted an enquiry to the MHRA suggesting that this might be an illegal product as it had no marketing authorisation. On the 14th of April 2008 I was told that the case had been passed onto the MHRA’s Enforcement and Intelligence Group.

Now you may have noticed that the MHRA’s listed values include

  • responsiveness;
  • timeliness;
  • professionalism;
So, it may come as a bit of a shock when I say that I got an email response back last week that said (in its entirety),

25th August 2009

I have been informed by our Enforcement Unit that an investigation has taken place in response to your complaint below. The outcome of the investigation is that following advice from the Enforcement Unit, Nelson’s have removed the product you mentioned from their display shelves.

Regards,

Yes, timeliness in this case means 17 months.

It may also come as a bit of a shock to find this product still for sale on Nelson’s website. It may have been ‘removed from the shelves’ but is still advertised on the web. You can also see other similar products that are intended to cure constipation, accident & injury, allergic reactions, bites & stings, hangover & indigestion, heat exhaustion, jet lag, and sun exposure. All the same sugar pill.

In fact, the Nelson’s web site is riddled with products that make specific claims and that do not appear to have any marketing authorisation.

Some examples:

So, what’s the harm? On the face of it, all the consumer will be getting is some sugar pill placebos and so there can be no more harm than any other homeopathic remedy. But the harm comes when the purchaser may well be relying on specific effects.

We saw recently how Neal’s Yard Remedies were selling sugar pills to customers and telling them that these could prevent malaria. The BBC undertook an investigation and interviewed their ‘Medicines’ Director, who stormed out of the meeting after being asked if this was ethical and legal.

After the BBC forwarded on their evidence, the MHRA investigated and slapped their wrists. That was it. Despite the appallingly irresponsible nature of Neal’s Yard behaviour the MHRA saw fit not to prosecute. I for one, was quite shocked.

The MHRA appear to be quite tolerant of homeopathic pharmacies sales processes. Why should this be? Could the MHRA think it not worth the effort to better police this sector? Are they under other influences to tread softly here?

I do not know. But the problem is deeper and more entrenched than even these problems suggest. Homeopaths are a group explicitly opposed to real medicine. They define their product in terms of direct opposition to medicine. From its first invention, homeopathy made grand claims to universality and having found the true philosophy of curing illness. All other approaches were heresy and to be opposed. This is what makes the vipers nest of homeopathy so insidious as a source of anti-scientific thinking about disease which leads to more widespread problems such the stubbornly unreasonable anti-vaccine movement.

We can see this foundation of anti-vaccine thinking in many homeopathic products. A large fraction of the Ainsworths medicine cabinet consists of homeopathic versions of vaccines. These are often in the form of what homeopaths call nosodes where some diseases tissue or some other ‘infectious’ agent is taken and serially diluted and shaken and probably banged against a leather bible many times to create the homeopathic witchcraft pill. Look at the remedy lists of Ainsworths and you will see a product for each Influenza strain going back 20 years. You will find homeopathic replacements for Measles vaccine, Parotitis vaccine (mumps) and Rubella. You find homeopathic sugar pills for all forms of Hepatitis, strains of TB, and Typhoid, as well as the usual comedy remedies such as shipwreck, trout and Ayres rock.

These products are making implicit claims to be alternatives to real vaccines. All of them are the same useless sugar pill pulled from the same large tub at Ainsworths, some hocus pocus spouted over them, bottled, labelled and shipped.

Why the MHRA do not prosecute for straightforward fraudulent trading I just do not know.

***********************************************************************************

Update

18th September 2009

Simon Perry from the excellent Adventures in Nonsense blog wrote to the MHRA to see what their response to this criticism would be. I have also written, but not received a reply.

Dear Mr Perry,

Thank you for your recent enquiry to the MHRA and please accept our apologies for the wait you have experienced. We have liaised with our enforcement team and the investigator involved and we can confirm that our response to this blog post is as follows:

“This referral was allocated to an investigator and concluded by way of a compliance visit when the product was removed from the shelves. The matter of the product being available via the company internet site has been referred to our enforcement group to take the appropriate action.”

Please contact us again if you need further assistance with this, or any other queries.

Kind Regards,

Ben, on behalf of the

Central Enquiry Point

Information Centre

Medicines and Healthcare products Regulatory Agency

At the time of writting, Nelsons are still selling the product online.

On this theme…

25 Comments on The MHRA and their Double Failure over Homeopathy

  1. Hi Andy,

    I have complained to the MHRA about some of these products on Boots websites – one month later I have an acknowledgment email, but that's all.

    What is surprising is that the MHRA seem to be entirely reactive – you mention one product in Nelson's which has been removed. This should have prompted MHRA to look at the full Nelson's range and deal with all the products as a job lot, rather than follow the letter of the complaint.

    T

  2. I am actually quite pleasantly shocked that they did take action against Nelson's, even if you had to wait so long. Maybe if people keep filing complaints, they will have to withdraw more products and think up new fancy names to rebrand them. That'll play hell with their marketing plans!
    Seriously though, I think it's a viable approach – after all, if someone has to comply to one withdrawal request afetr another, how long would it take to realize thet all their products are bogus?

  3. "The 1:1060 dilution is a bit misleading; perhaps it should read 10^60?"

    Yes, of course. My editored displyed this correctly. The web page does not – html problem – so reworded.

  4. I'm not sure how much manpower the MHRA really has, but it does seem like it's ill-equipped to deal with a potential deluge of complaints by skeptics – not that I'm saying it isn't worth submitting a complaint, it's just that it's not too surprising that they took so long to get back to you.

    As for Nelson's, it's no wonder they contiune to market an otherwise discredited 'remedy' online – you can get away with all sorts of stuff on teh internets that simply isn't allowed in the real world…

  5. Has anyone ever calculated the tax revenues from alternative enterprises as the government need some replacement for the alleged fall in tobacco taxes? Smoking costs the NHS a fortune while alternative enterprises may actually save costs on the NHS by diverting those who wish to spend their cash on shaken sugar-water while nature heals naturally. I know some of the delays in seeking conventional medical care and certain contra-indications of swallowing quack medicines may cause harm but unfortunately there is no Quack Flu Pandemic indicating its deceit.

    I understand and fully support the legitimate pursuit to hold quack shysterism to account for contaminating the integrity of science etc. – but I suspect it earns the Treasury a useful sum which may encourage the governmemt regulatory systems to hold back.

  6. My research group's experience (and the experience of colleagues) is that the MHRA make clinical researchers jump through a number of expensive, time-consuming hoops, even for the smallest studies that reflect standard clincial practice. This has the effect of discourgaging only the most-dedicated from undertaking any drug studies.

    The fact they simultaneously tolerate these fruitbats demonstrates a frustating lack of consistency.

  7. Has anyone calculated the tax revenues from alternative enterprises? This may be enlightening as to why, perhaps, the government regulatory bodies appear reluctant to intervene?
    There is unfortunately no Quack Flu Pandemic exposing the gullibility of its customers to reveal the extent of alternative deceit and so it continues to make money.

    Knocking back attractively labelled tap-water may well be diverting many who would otherwise fill up GP and NHS waiting rooms and add extra costs to the NHS. The tax lost from the alleged reduction of smoking and black market gaspers has to be made up somehow?

  8. Indeed.

    Were I a homeopath, I'd also be pretty nervous about the implications of the recent Consumer Protection from Unfair Trading Regs. Ground 17 of the Schedule 1 (which sets out "commerical practices which are in all circumstances considered unfair"), for example, forbids:

    "Falsely claiming that a product is able to cure illnesses, dysfunction or malformations."

    And I'd have thought that a lot of their claims would fall foul of the defintion of "misleading actions" in r.5.

    There's also a duty on the OFT to enforce the regulations (r19).

    Actually, I may have some time on my hands over the next few month. I shall look into this further.

  9. I read through the European regulations on this a while ago. I'll preface this by saying I'm not in general a Eurosceptic.

    The European regulations for the licensing of medical products seemed set up to ensure that anything licensed in one part of the EU could be retailed in any other part. Which does make sense, except that the French and Germans are still really into Homoeopathy.

    With regard to homoeopathy, remedies can be licensed with a countries MHRA equivalent without proof of efficacy provided it is diluted to the point that no molecule of active ingredient remains and there is suitable QC on the product to ensure safety. I'm not clear if once this has been done in one country the licence must be honoured in all other EU countries.

    I wonder if the MHRA is genuinely stuck on the regulations here and if there is also a political aspect with free trade across Europe.

  10. Personally I'd be interested to know where Ainsworths got their 'Ayers Rock' from. The stuff they sell doesn't really have any in, of course, but if they're not just making it up then they presumably have a more concentrated version somewhere, which might have a measurable amount in. They also have Tyrannosaurus Rex (WTF!!!) and I've also seen things like 'stonehenge' or 'mummy' somewhere, which might be illegal to have, certainly illegal to buy these days. Anyway, it would be interesting to try to challenge them on those grounds, and see whether they admit that there isn't any of the substance in the 'remedy'. Perhaps someone could have a look through their lists for endangered species.

  11. Forgive me for being marked out as an idiot by choosing to remain anonymous pro tem, but I take re-assurance in the fact that there are those even more intellectually challenged than I that must be buying homeopathic remedies from a website that clearly states "Ainsworth's homeopathic products are without approved therapeutic indications"

  12. "Perhaps someone could have a look through their lists for endangered species".

    Well, they've got alligator on there, wish I could see them getting that one, and there's an unending list of spiders and reptiles, pig embryos etc. I'm afraid I didn't specifically look for endangered species. Some of the birds are probably on the risky list, but as only feathers seem to be used, I assume a homeopath just stands underneath until one falls out. I registered for a "provings" list,to give evidence to people who thought homeopathy was exclusively plant based. (I'm vegan). It now costs $25 dollars to belong to this register, which seems a bit expensive for the modest amusement it affords.

  13. A quote from http://www.helios.co.uk/technical.html

    "
    In 1994 after two years of research and development, Helios was proud to be the first British company to have its own high potency succussion machine. To make a high potency by hand would take weeks or months and is extremely labour intensive. In designing the Helios potentiser we have adhered as closely as possible to the human arm action of dilution and succussion "against a hard but elastic object" (aphorism 270 ) as per Hahnemann's instructions. The machine repeatedly empties and refills in a single vial (Korsakov method) until the desired potency is reached, the whole process being computer-controlled to ensure stability and accuracy. A constant supply of highly purified water is used as the diluent.

    "

    Presumably exactly 1/100 of the contents of the vial adhere to the inside of the vial when vial is upended and emptied down the sink!

    Presumably the contents of their skulls have also been emptied down the sink. 😀

  14. Billy Joe:
    Are you sure it is the "Korsakov method" and not "Korsakoff's Syndrome"?
    That would make far more sense, and explain an awful lot of their criminal confabulation.

  15. OT – Andy, are you familiar with quackometer.com? I just ended up there after clicking a link on Lay Scientist. Thought you'd been hacked.

  16. A homeopathic sugar pill has a negligible chance of containing a molecule of the claimed ingredient. But then any sugar pill, once taken from its container, also has a negligible chance of containing the same molecule. So legally there can't be any difference between the two.
    Anyone else tempted to start rebranding sugar pills and selling them online? If the MHRA come calling, change the packaging and sell it as something else…

  17. I am a chartered consultant engineer with a PhD, and both by profession and by nature I am sceptical of anything that cannot be explained empirically or scientifically. In my personal experience homeoepathic remedies can work, but not always. Two examples: From an early age I suffered from teeth-grinding when asleep, causing loss of sleep to my wife, and flattened teeth with chisel sharp edges. All my dentist could offer was a set of plastic caps to prevent teeth contact. Without much hope, and feeling a bit foolish, I consulted a recommended homeoepath. His first and only prescription took less than a week to cure the syndrome completely and permanently. Although my teeth have not re-grown, the edges are no longer sharp, but more importantly, I do not wake my wife by teeth-grinding – she should know. If it was a placebo effect then does that invalidate the cure? My second example is curing animals which presumably cannot be a placebo effect. I used to keep chickens, and these are prone to feather-pecking especially when bored in winter. I found a tablet of silicea (I think it was) in the drinking water often had an immediate beneficial effect. All I know is that life is full of inexplicable mystery and as Shakespeare so trenchantly put it “there are more things in this world than are dreamt of in your philosophy”.

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