British Advertising Standards Authority
Adjudication on Ainsworths (london) Ltd
27 July 2011
Ainsworths (London) Ltd t/a
Ainsworths Homeopathic Pharmacy
Lower Coombe Street
Sector: Health and beauty
Number of complaints: 2
Complaint Ref: 105098
Date: 27 July 2011
Sector: Health and beauty
Number of complaints: 1
Complaint Ref: A11-148070
A leaflet that offered "Homeopathic Travel Prophylaxis" made a number of claims about the ways that homeopathic products could help people when they travelled abroad. Under the heading "HOMEOPATHIC PROPHYLAXIS", text stated "Conventional holiday vaccination involves injecting a foreign protein into the blood. Homeopathic prevention is more subtle and relies on an oral dose of the same material in a highly diluted and potentised form. We offer homeopathic alternatives to conventional travel immunisations, depending on which areas you are travelling to. Examples of diseases travellers often encounter are: Typhoid, Diphtheria, Tetanus, Polio, Yellow Fever, Meningitis, Japanese Encephalitis, Tick-Bourne [sic] Encephalitis, Dengue Fever and Malaria. 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 the anecdotal evidence of those who have chosen to use them successfully throughout the world". The leaflet went on to refer to the uses, benefits and suggested doses of a number of products and concluded with text that stated "AINSWORTHS TRAVEL KIT An indispensible aid for your holiday. 10 important remedies in a pocket leather wallet, at a special price of £33.00 (value of separate items and wallet over £66.00)".
One member of the public, who later became associated with the Nightingale Collaboration, objected to the leaflet and challenged whether:
1. It misleadingly implied that homeopathic products acted as prophylactics and were safer and less invasive than "conventional holiday vaccinations".
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.
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.
4. The references to "dose", "tablet", "exposure" and "active cases" misleadingly implied that homeopathic products were equivalent to conventional medicines.
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.
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.
8. The claim "An indispensible 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.
Ainsworths (London) Limited t/a Ainsworths Homeopathic Pharmacy (Ainsworths) stated that they were one of only three pharmacies in the UK that specialised exclusively in homeopathic medicines and that their customers had therefore already made a choice to consider options that did not conform to the conventional concept of medicine. They stated that they did not advertise and that the leaflet was not intended to be a stand-alone source of information. They said the leaflet consolidated information given, in person or by telephone, by a highly trained member of staff and that it formed only one small part of their travel advice. They said staff offered balanced advice on customers' individual circumstances before any remedy was dispensed in order to ensure customers could make an informed choice between homeopathic and conventional treatment and that they were encouraged to follow conventional vaccination opportunities first unless there was specific reason not to do so. They advised that the leaflet had already been withdrawn because they felt it required revision.
1. Ainsworths advised that the concept of homeoprophylaxis (homeopathic disease prevention) had featured as a central tenet of homeopathy since the practice first began. They said the implied claim that homeopathic products were effective prophylactics was evidenced by the founding principles of homeopathy, supported by a body of literature, reference texts, animal studies and human trials. They said that there had been 142 peer-reviewed randomised controlled trials into the efficacy of homeopathy generally and that 44% reported positive findings (8% reported negative findings and 48% were inconclusive). They said there had been five major reviews of these trials of which only one had concluded that homeopathy did not perform better than a placebo.
Ainsworths stated that homeoprophylaxis was effective for a short period of time with no side effects and that it enhanced individuals' immune systems. They advised that conventional vaccination introduced a foreign protein into the body in order to stimulate an antibody response. They believed that while this method had been shown to work in clinical trials, it also negatively impacted on individuals' overall health because it undermined the immune system's capacity to respond to epidemic disease. They believed this rendered individuals more susceptible to chronic disease and more serious health problems than they were before receiving the vaccine. They believed practitioners of conventional medicine ignored this fact. They referred to an article that appeared in the British Medical Journal on 9 June 2007 that questioned whether the use of the human papillomavirus vaccine Gardasil in the USA and Australia was responsible for three deaths and 1,637 other adverse reactions. They also provided a research paper which reported damage to pets as a result of routine annual vaccination and data from the Veterinary Medicines Directorate which showed that routine vaccination was the most common cause of adverse reactions, accounting for approximately 30% of total adverse reports.
2. Ainsworths referred back to their response to point 1. They believed that, from the evidence they had obtained, the homeopathic products they offered were as effective as conventional vaccinations. They said homeopathic products were a short term alternative to conventional vaccinations for people who were liable to encounter epidemic disease. They referred to a recent trial of 2.5 million people in Cuba which they said demonstrated that the introduction of homeopathic methods of disease prevention resulted in an 80% reduction in the incidence of Leptospirosis between 2007 and 2008. They believed the validity of the principles of homeoprophylaxis had been borne out in relation to many other diseases.
3. Ainsworths stated that randomised controlled trials were not required to support therapeutic claims for homeopathic products licensed (and issued with a marketing authorisation) by the Medicines and Healthcare products Regulatory Agency (MHRA). They had nevertheless considered it appropriate to inform readers that no clinical evidence existed to support the claims made for the products mentioned in the leaflet. They believed this disclaimer made it clear to readers that they could balance the information contained in the leaflet with information available from their GP regarding conventional vaccines before making a decision. They said the issue of the evidence base for their products would be discussed in depth before products were sold so that customers were in no doubt regarding this.
4. Ainsworths said homeopathy formed part of the NHS and that homeopathic products were licensed by the MHRA. They advised that homeopathic products were manufactured under the same "good manufacturing practice" conditions as conventional drugs and that they were prepared by specialist homeopathic pharmacies. They believed that homeopathic products were clearly medicinal and that in this regard the complaint made a distinction between homeopathic and conventional medicine that did not exist.
5. Ainsworths stated that, as part of the balanced advice given by highly trained staff to all customers before products were sold, these statements would have been substantiated by clinical findings referenced from the homeopathic Materia Medica. They advised that bibliographic evidence from traditional reference sources such as the Materia Medica was sufficient for the MHRA to license a homeopathic product. They also advised that, as a registered pharmacy, they were entitled to dispense unlicensed products to individuals on request under the supervision of a pharmacist in terms of section 10 of the Medicines Act 1968. They said the remedies referred to in the leaflet were natural substances that could be prepared at a customer's request and they believed providing information about these substances was different from promoting a specific product with a determined pharmaceutical form.
6. Ainsworths referred back to their response to point 5.
7. Ainsworths referred back to their response to point 5. They believed that neither Apis 30C nor Histamine 200x bore close relation to any known brand name drug. They advised that all homeopathic products were named after the natural substances they contained.
8. Ainsworths stated that 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. They pointed out that the travel kit advertised in the leaflet contained remedies for minor ailments for which no claims were made and that it did not contain the homeoprophylaxis remedies described in the leaflet.
The ASA understood that the leaflet was intended to be supplemental to travel advice given in person by Ainsworths staff. We considered, however, that the oral information was unlikely to contradict the claims made for homeoprophylaxis in the leaflet and we noted that the leaflet could be retained by individuals and the travel kit could then be bought on the company's website at a later date. We acknowledged that Ainsworths staff was trained to advise customers to first pursue conventional options available from their physician. We noted that the leaflet had been withdrawn.
We noted that there was a large volume of information that had been gathered over the last few hundred years in support of the effectiveness of homeopathic medicine. We noted that Ainsworths believed this information demonstrated that homeopathic products could successfully protect individuals against serious infectious diseases. We noted, however, 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 noted that the number of randomised controlled trials involving homeopathy was very small and this was cited by the The British Homeopathic Association in the evidence it provided to the House of Commons Science and Technology Committee as one of a number of factors that limited the value of any comprehensive review of those trials. Furthermore, we understood that there had been more than the five reviews of those trials that Ainsworths referred to and that many of the reviews they had omitted reported negative outcomes for homeopathy.
We understood that there was currently no generally accepted scientific rationale for assuming that homeopathic products, which lacked pharmacologically active molecules, could produce clinical effects. We considered that there was no broad acceptance of the evidence supporting the efficacy of homeopathy and we noted that this was the position adopted by the Science and Technology Committee in its recent report "Evidence Check 2: Homeopathy". We considered that Ainsworths 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.
We understood that adverse reactions to conventional vaccines could occur in some individuals and we noted the terms of the BMJ article and the other resources that Ainsworths referred to. We understood that homeopathic products were generally designed to be ingested, rather than delivered directly into the bloodstream, and that they had been shown to have no side-effects. We considered, however, that readers would infer from the leaflet as a whole that homeopathic products were viable alternatives to conventional holiday vaccines and that they were in fact preferable because they were safer and less invasive. We noted that the leaflet did not state that customers should follow conventional vaccination opportunities first unless there was specific reason not to do so. We therefore considered that the leaflet was irresponsible, because it was likely to discourage readers from seeking medical advice regarding conventional vaccination against serious infectious diseases.
On this point the leaflet breached CAP Code (Edition 12) rules 1.3 (Social responsibility), 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1, 12.2 and 12.6 (Medicinal claims).
We understood that a homeopathic medicine had been used as part of the treatment of Leptospirosis in Cuba and that during the same year and years that followed, it had been reported that incidences of the disease had decreased significantly. We considered that in order to fully understand the role of homeopathy in the treatment of a disease, clinical evidence would need to demonstrate how that remedy acted upon the disease within the body, before then demonstrating how that remedy could be used in the field. 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 did not regard this report as having demonstrated the efficacy of homeopathic products in the treatment of Leptospirosis in clinical conditions and we had not seen any evidence to support Ainsworths 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. We considered that Ainsworths 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.
On this point the leaflet breached CAP Code (Edition 12) rules 1.3 (Social responsibility), 3.1 (Misleading advertising), 3.7 (Substantiation), 3.11 (Exaggeration) and 12.1, 12.2 and 12.6 (Medicinal claims).
We noted that Ainsworths considered they had acted responsibly by stating that the effectiveness of their products had not been established in clinical trials. We accepted that the efficacy of homeopathic products did not need to be demonstrated in randomised controlled trials in order to obtain an MHRA marketing authorisation; but we understood that the product indications allowed by the marketing authorisations they issued were limited to the relief or treatment of minor symptoms or minor conditions.
We noted that the disclaimer "Since these products have not been tested in clinical trials we are unable to make claims for the effectiveness of this method of disease prevention" was immediately qualified by the statement that Ainsworths relied instead on the testimony of those that had used the products "successfully throughout the world". We considered that the statement contradicted the disclaimer and implied a widespread acceptance of the effectiveness of the products in non-clinical conditions. We had not seen evidence to suggest that such broad acceptance of the effectiveness of these products existed. In the context of a leaflet that referred to serious infectious diseases, we considered that the disclaimer, which was immediately qualified, was insufficient to make readers suitably aware of the limitations of the advertised products. We concluded that the leaflet was misleading and irresponsible, because it could discourage readers from seeking medical advice regarding conventional vaccination against serious infectious diseases.
On this point the leaflet breached CAP Code (Edition 12) rules 1.3 (Social responsibility), 3.1 (Misleading advertising), 3.7 (Substantiation), 3.9 (Qualification) and 12.1, 12.2 and 12.6 (Medicinal claims).
4. Not upheld
We accepted that some homeopathic products were licensed by the MHRA and that homeopathy was an established part of the NHS. We therefore considered that it was appropriate to use terms such as "dose", "tablet", "exposure" and "active cases" in relation to homeopathic products.
On this point we investigated the leaflet under CAP Code (Edition 12) rules 3.1 and 3.6 (Misleading advertising), 3.7 (Substantiation) and 12.1, 12.2 and 12.6 (Medicinal claims) but did not find it to be in breach.
5 & 6. Upheld
The MHRA stated that homeopathic products must be licensed before they could be advertised, even in leaflets which were available only at the point of sale. We were advised by the MHRA that unlicensed homeopathic products could be dispensed in registered pharmacies under the supervision of a pharmacist in certain circumstances but nevertheless considered that that was irrelevant in relation to the marketing of unlicensed homeopathic products.
We considered that the claims made in relation to Chelidonium 6X, Ceanothus 6X and the "Anti-Bite Tincture" implied that those three remedies had a physiological effect on the body and were effective for the medicinal uses stated in the leaflet. We understood that these were natural substances that would be made into a finished product at a customer's request but we did not consider that this effected Ainsworths obligation to provide scientific evidence to substantiate the claimed medicinal uses; and they had not provided scientific evidence to support the claims made. Furthermore, we had not seen evidence from Ainsworths that they held an MHRA marketing authorisation for Chelidonium 6X, Ceanothus 6X or the "Anti-Bite Tincture". We therefore considered that the leaflet had made unsubstantiated medicinal claims for unlicensed products, which was a breach of the code, and that it was misleading.
On these points the leaflet breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation), 3.11 (Exaggeration), 12.1, 12.2 and 12.6 (Medicinal claims) and 12.20 (Homeopathic medicinal products).
We noted that homeopathic products were named after the natural products from which they were made. We understood that a number of conventional medicines were collectively referred to as "antihistamines", but we were not aware of any conventional brand name drug that could be confused with Histamine 200x, or with Apis 30C.
We noted that the MHRA had issued a marketing authorisation for Apis 30C but that there were no approved indications for the product. We considered that the product information given in the leaflet should therefore have been confined to what appeared on the product label. We had not seen evidence from Ainsworths that they held a marketing authorisation for Histamine 200x. We concluded that the leaflet made unauthorised medicinal claims in respect of both products, which was a breach of the Code, and that it was misleading.
On this point the leaflet breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation), 3.11 (Exaggeration), 12.1, 12.2 and 12.6 (Medicinal claims) and 12.20 (Homeopathic medicinal products).
We noted that the travel kit contained remedies for minor ailments only, but we considered that the leaflet implied the travel kit contained the homeoprophylaxis remedies that had been mentioned and that it had recommended those products as an alternative to conventional vaccinations for the purpose of protecting customers against serious infectious diseases. In that context, we considered that reference to the products as "indispensible" and "important" reinforced the impression that the remedies mentioned were effective in preventing those diseases. 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.
On this point the leaflet breached CAP Code (Edition 12) rules 1.3 (Social responsibility), 3.1 and 3.6 (Misleading advertising), 3.11 (Exaggeration), 12.2 and 12.6 (Medicinal claims) and 12.20 (Homeopathic medicinal products).
We understood that the leaflet had already been withdrawn. We told Ainsworths 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 the MHRA marketing authorisation.
This page was posted on July 27, 2010.