Zeno's Blog

It’s bad enough when homeopaths take good money from people, claiming they can cure their colds or clear up their eczema with sugar pills. It’s another thing entirely to claim to prevent or treat serious diseases with identical sugar pills.

But this is precisely what the BBC’s Newsnight programme discovered homeopaths were doing. Broadcast in January, Pallab Ghosh exposed the disgraceful behaviour of a north London homeopath and a homeopathic ‘pharmacy’ selling sugar pills as a malaria preventative.

Watch the whole sorry exposure, even if you’ve watched it before:

As Dr Simon Singh said on the programme:

Choice is fine as long as it’s based on accurate information. And the information that’s being given out by pharmacists, by celebrities endorsing homeopathy, by the NHS offering homeopathy — the implication here that homeopathy must be effective otherwise people wouldn’t sell it, profit from it or offer it in the high street. And I am utterly shocked that we have a woman here [Zofia Dymitr, Chairwoman of the Society of Homeopaths] saying that she’s not going to forbid her members from offering homeopathic prevention of malaria to the general public. There are people coming back from tropical countries with multiple organ failure having used homeopathy and yet this woman is not prepared to stop it.

I was here four years ago when Newsnight did your last investigation and BBC Scotland have done an investigation and BBC South West have done an investigation. The BBC are the only people regulating homeopathy at the moment, because the Society itself seems to be oblivious to its responsibility.

Dymitr responded:

I would disagree very strongly with you there, Simon. We are a responsible organisation and we do issue very clear guidance to members in relation to what they should say to patients who are seeking an alternative…

Wark interrupted:

Surely you should actually you presumably regard yourself as a professional body. As a professional body you should not be issuing guidance but saying “you will not be allowed to belong to any homeopathic organisation if you continue to offer people these supposed remedies for things like typhus and yellow fever”?

After Dymitr tried to introduce an anecdote — so favoured by the believers in magic sugar pills — an exasperated Wark asked:

Should you be saying to those involved in your association if you continue to promote the idea that homeopathic remedies simply by anecdotal evidence might be OK those people should not belong to your association?

Dymitr said:

We are very clear in the guidance that we offer our members and should any member of the public wish to make a specific complaint about any information given by one of our members in relation to advice about using remedies for malaria or any other condition we do have full professional conduct procedures in place.

…

It’s not actually appropriate for the Society to investigate an alleged statement made by a member from an edited clip played on Newsnight…What I would and I have said is that if that individual reporter wishes to make a complaint then by all means let her come to the Society and will put our full professional conduct procedures in place. I can absolutely assure you that would be the case.

Reassuring statements indeed.

After this dismal showing, the Society of Homeopaths (SoH) issued a press release that has been taken apart by Andy Lewis.

Complaints

Something needed to be done and I took up the gauntlet.

Since the person in charge of Ainsworths Homeopathic Pharmacy, Anthony Pinkus, was a registered pharmacist, I submitted a complaint to the statutory regulator of pharmacists, the General Pharmaceutical Council. I’ll save the gory details of how they dealt with my complaint for a future blog post.

The SoH weren’t willing to do anything about one of their members without an outsider lodging a complaint with them. I obliged. Again, I’ll save the details for another time.

For now, I’ll concentrate on the complaint I submitted to the Advertising Standards Authority.

Ainsworths gave the researcher a leaflet — you can see it at 4:35 into the video. Pallab Ghosh passed it to me to deal with. Titled Homeopathic Travel Prophylaxis, it is truly shocking.

The ASA’s adjudication is published today, upheld on all but one issue.

Click on each image to enlarge.

My complaint was comprehensive, but was lengthy because of the number of questionable claims being made, even in such a short leaflet.

After the Newsnight programme and after all the adverse publicity that Ainsworths and the Society of Homeopaths received, I find it incredible that Ainsworths chose to fight the complaint, rather than simply change or withdraw the leaflet.

But how Ainsworths fought the complaint is instructive and I recommend reading the full adjudication. However, I’ll highlight a few points.

The issues

The ASA distilled my complaint into eight issues, stating:

One reader objected to the ad and challenged whether:

Issue 1

1. It misleadingly implied that homeopathic products acted as prophylactics and were safer and less invasive than “conventional holiday vaccinations”

Ainsworths said that homeoprophylaxis (prevention of diseases using homeopathy) had been a central tenet of homeopathy since it was invented. The evidence, they maintained, was that it was in the founding principles of homeopathy, supported by all sorts of trials. They said there had been 142 peer-reviewed randomised controlled trials into the efficacy of homeopathy and that 44% reported positive findings, 8% negative and 48 inconclusive. This is the line taken by the SOH. It is also incorrect, of course. There are many explanations of why this evidence isn’t the evidence homeopaths like to think it is.[1. For example, see Discover Homeopathy, The Evidence For Homeopathy and A Beginner’s Guide To Homeopathy] The astute reader will appreciate that even if these trials did give the results Ainsworths wished, this is not evidence that homeoprophylaxis is effective; and certainly not up to the standard required by the ASA. The ASA considered the ‘evidence’ supplied, and said:

We noted that many of the human trials which reported positive outcomes for homeopathic products were based on patient self- assessment and did not examine the scientific rationale for any reported changes in the physiological or psychological health of patients. We understood that no scientific rationale existed for assuming that homeopathic products, which lacked pharmacologically active molecules, could produce clinical effects. We considered that Ainsworth’s had not provided sufficiently robust scientific evidence, including double-blind, placebo controlled clinical trials, to substantiate the implied claim that homeopathic products were effective prophylactics. We concluded that the leaflet was therefore misleading.

Their ‘evidence’ just wasn’t good enough.

Issue 2

2. It misleadingly implied that homeopathic products were as effective as conventional holiday vaccinations at treating or preventing typhoid, diphtheria, tetanus, polio, yellow fever, meningitis, Japanese encephalitis, tick-bourne [sic] encephalitis, dengue fever and malaria.

Ainsworths referred the ASA to what they said about the first issue. They also mentioned the oft-cited Cuba Leptospirosis trial of homeopathy. They claimed it involved 2.5 million people and that it demonstrated that the introduction of  ‘homeopathic methods of disease prevention’ resulted in an 80% reduction in the incidence of Leptospirosis in 2007 and 2008. That ‘trial’ demonstrated no such thing, of course — for a clinical dissection of  this ‘evidence’, see AP Gaylard’s Much ado about nothing.

The ASA didn’t think much of it either:

We noted evidence had not been supplied to demonstrate that the homeopathic medicine referred to in the report had been shown to be efficacious against Leptospirosis under clinical conditions. We also noted the report on the implementation of the epidemic control application did not show that any reduction in the disease was directly or in part attributed to the homeopathic treatment. Moreover, we considered that it had not been demonstrated that the reduction in reports of Leptospirosis were not due to an increase in education about the disease or any other external factors. We did not regard this report as having demonstrated the efficacy of homeopathic products in the treatment of Leptospirosis and we had not seen any evidence to support Ainsworth’s belief that homeoprophylaxis had been successful in relation to any other diseases.

We considered that, by making reference to serious infectious diseases such as typhoid, tetanus, polio, meningitis, Japanese encephalitis and malaria, the leaflet implied homeopathic products were effective in treating those conditions. As stated in our assessment of point 1 above, we understood that no scientific rationale existed to support the efficacy of homeopathic products. We considered that Ainsworth’s had not provided sufficiently robust scientific evidence to support the implied claim and we concluded that the leaflet was therefore misleading and irresponsible, because it could discourage readers from seeking medical advice regarding conventional vaccination against serious infectious diseases.

Although Pinkus has written about this homeopathic miracle, it’s not even clear if the homeopathic potion used in Cuba was the same as the one the leaflet is referring to. I can’t believe I’ve just written that — homeopathic potions above about 12C are identical regardless of the mother tincture used and regardless of the dilution — they are unlikely to contain even one molecule of the original substance. The homeopathic potions used in the Cuba ‘experiment’ used nosodes of the four Leptospirosis strains circulating at the time, firstly to 200C dilution and subsequently to a staggering 10M dilution (1:1000¹⁰ ie 1 with 30 zeros after it), just to make it more powerful, of course. And they threw in a Bach flower ‘remedy’ to help relieve stress after hurricane Ike hit the island.

This demolition of a pinnacle of homeopathic research is damning and worth savouring.

Issue 3

3. The disclaimer “Since these remedies have not been tested in clinical trials we are unable to make claims for the effectiveness of this method of disease prevention. Instead we rely on anecdotal evidence of those who have chosen to use them successfully throughout the world” was misleading and contradicted the rest of the ad, which the reader believed made both implicit and explicit claims about the capacity of homeopathic products to prevent or relieve the symptoms of the diseases mentioned.

Ainsworths believed they were being responsible in telling us there is no robust evidence for homeopathy. Well, we already  know that, but some members of the public may not, so that was good of them, wasn’t it?

And it’s good of them to make clear that they are relying on stories they’ve gleaned from anyone and anywhere. The ASA were not moved by this uncharacteristic openness and said that their claims were contradicted by the disclaimer and that it implied a wide acceptance of the effectiveness of homeopathy and the disclaimer, in the context of a leaflet extolling the virtues of homeopathy for serious infectious diseases, was ‘insufficient to make readers suitably aware of the limitations of the advertised products’. Those limitations are, of course, that homeopathic products don’t work.

Issue 4

4. The references to “dose”, “tablet”, “exposure” and “active cases” misleadingly implied that homeopathic products were equivalent to conventional medicines.

The ASA didn’t uphold this part of my complaint. The point I was making was that the judicious use of language can lead members of the public to think these sugar pills really are medicines, when they are little different from what you can buy far more cheaply from your local grocer. Although the ASA didn’t agree with me this time, I will be trying again in future complaints to convince them that such medical language places such products in a context that makes it misleading.

Issues 5 & 6

5. The claim that Chelidonium 6X and Ceanothus 6X could “maintain liver and spleen health and improve natural immunity when travelling” was misleading and could be substantiated.

6. The claim that the “Anti-Bite Tincture” could prevent or help to reduce the effects of mosquito bites was misleading and could be substantiated.

For these, Ainsworths cited ‘clinical findings referenced from the homeopathic Materia Medica‘ as if that was a respectable peer-reviewed scientific journal. They said that such evidence was sufficient to convince the MHRA to issue licences for sugar pills. This is utterly irrelevant, of course: the MHRA doesn’t require any evidence of efficacy for homeopathy before it dishes out authoritative-looking licence numbers. Moreover, although Ainsworths have no products that have a Product Licence of Right and have licences for just 33 (all identical, since they contain nothing other than lactose and sucrose) products under the National Rules Scheme, the ones mentioned in the leaflet aren’t listed![2. The Ainsworths‘ products that have MHRA licences under the National Rules Scheme are: aconite, allium cepa, apis, argent. nit., arnica, arsen. alb., belladonna, bryonia, cantharis, carbo veg., chamomilla, cocculus, drosera, euphrasia, ferrum phos., gelsemium, hepar sulp, hypericum, kali bich., ledum, mag phos., merc. sol., mixed pollens, nat. mur., nux vomica, passiflora co., phosphorus, pulsatilla, rhus tox., ruta, sepia, silica, sulphur. The ones mentioned in the leaflet as helping with malaria prevention are chelidonium and ceanothus.]

However, for some unfathomable reason, a registered homeopathic pharmacy is treated as if was a pharmacy selling proper medicines and is allowed to dispense unlicenced sugar pills. (The question that raises, of course, is whether anyone other than a registered pharmacy or a registered pharmacist is legally entitled to dispense unlicenced homeopathic products. This has been covered in detail on the blog The Land That Tim Forgot.)

The ASA emphasised that it was the responsibility of the advertiser to hold scientific evidence for claims made and, since Ainsworths hadn’t supplied any, the ASA concluded that ad was misleading.

Issue 7

7. The claim “Take Apis 30c if the bites become hot and inflamed. Histamine 200x taken twice daily can help reduce an allergic reaction to bites” was misleading and could be substantiated. The reader believed that the ad misleadingly compared homeopathic products with a conventional medical product of the same name.

Ainsworths protested that there was no medical product called histamine that their product could be confused with. I could perhaps have worded my complaint better, but nevertheless, the ASA upheld this point because the products mentioned were unlicenced homeopathic products and Ainsworths were therefore making unauthorised medicinal claims.

Issue 8

8. The claim “An indispensible [sic] aid for your holiday. 10 important remedies in a pocket leather wallet, at a special price of £33.00” misleadingly implied that homeopathic products were effective and useful for different and possibly serious medical conditions.

For some bizarre reason, Ainsworths, responded to this by saying:

…homeopathy had been part of the NHS since 1948 and that there were five national homeopathic hospitals in the UK, each with both in and outpatient wards. They believed that the history and practice of homeopathy in the UK justified the claim to the importance of homeopathy and homeopathic products.

An appeal to tradition fallacy of just 62 years! Not good enough. The ASA concluded:

We also considered that it implied the products were an essential purchase for those travelling abroad, which we concluded was irresponsible, because it could discourage readers from seeking medical advice regarding conventional vaccination against serious infectious diseases.

Breaches

It’s worth listing the ten CAP Code rules Ainsworths managed to breach — some several times — in this rather sparse leaflet:

• 1.3 (Social responsibility) four times
• 3.1 (Misleading advertising) seven times
• 3.6 (Misleading advertising) once
• 3.7 (Substantiation)  six times
• 3.9 (Qualification) once
• 3.11 (Exaggeration) five times
• 12.1 (Medicinal claims) six times
• 12.2 (Medicinal claims) seven times
• 12.6 (Medicinal claims) seven times
• 12.20 (Homeopathic medicinal products) four times

That’s an amazing 48 individual breaches in 489 words; one for every ten words. Is this a record?

It’s usual to see adjudications on adverts for alternative therapies breaching the rules on substantiation and medical claims, but the first one is relatively new and says:

Marketing communications must be prepared with a sense of responsibility to consumers and to society.

So, this leaflet was deemed to be irresponsible as well as misleading.

The ASA concluded:

Action

We understood that the leaflet had already been withdrawn. We told Ainsworth’s to ensure in future that no marketing communications referred to serious medical conditions. We told them no medicinal claims should be made for unlicensed homeopathic products and that medicinal claims for licensed homeopathic products should not include indications other than those allowed by its MHRA marketing authorisation.

Summary

This is a long and involved adjudication — particularly considering it’s about a leaflet of less than 500 words. But it’s an important one: Ainsworths claim they offer the largest range of homeopathic products and are one of only six meopathic ‘pharmacies’ that are registered with the General Pharmaceutical Council.

The fact that such pharmacies are given the imprimatur of statutory regulation is worrying to those who seek to ensure the public is not misled into believing sugar pills are real medicines.

But perhaps this statutory regulation could be a good thing? It might ensure that pharmacies don’t mislead the public and provide a way of taking the person responsible to task when they do. However, it hasn’t turned out quite like that, but, as I said above, I’ll save that for a future blog post.

I also complained to the Society of Homeopaths because Ainsworths‘ Superintendent pharmacist (ie the person who is responsible for setting out the standards and policies for the provision of pharmacy services) is one of their members. However, there doesn’t seem to be many reasons to be confident in their complaints process and their ability to protect the public.

It’s worth mentioning that the adjudication has undergone several drafts, with both myself and Ainsworths having the opportunity to comment on each one. There were a couple of points I could have raised that I didn’t think were quite right, but, although I did make come comments, I didn’t feel it was worth giving the ASA even more work when it looked as if they were going to uphold all but one issue.

You may also like to read Andy Lewis’ blogpost on the same subject: Ainsworths Pharmacy: Casual Disregard for the Law.

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