By Dr. Terry Maguire, a Northern Irish Community Pharmacist, senior lecturer at School of Pharmacy (Queens University Belfast) and Belfast LCG member.
The Emerging Credibility of Homeopathy? – Published previously in Pharmacy in Focus
Through anger borne of frustration I have decided to write to PSNI. Why are homeopathic medicines allowed? They are viewed as innocuous remedies incapable of causing any harm but it is obvious to anyone with two or more neurones that homeopathic remedies could be used to treat conditions for which they are ineffective and for this reason real harm might result. Concern is already documented on use of homeopathic remedies for malaria prophylaxis and treatment which any right thinking person would consider inappropriate. Yet there are many pharmacists who remain undeterred in their support.
The UK drugs regulator, MHRA, was asked by the Sunday Telegraph to investigate a London based pharmacy for selling a homeopathic remedy to treat swine flu and called “Swine Flu Formula”. I applaud the public spirit of the newspaper for bringing this issue to public attention but I was bitterly disappointed with the outcome.
The MHRA investigated and concluded that, in the promotion of a homeopathic medicine for treatment of swine flu, no law had been broken. MHRA awards marketing authorisations for medicines but few appreciate that MHRA also license homeopathic medicines. This could be viewed, as was expressed in an article in Lancet, as a conflict of interest and which may serve to reduce MHRA’s credibility as an objective regulator of medicines. A colleague, stimulated into action by the Lancet paper, corresponded with the MHRA, concerned that perhaps the public might assume that regulation would assure in the eyes of the consumer an element of safety, quality and efficacy of homeopathic medicines.
The Central Enquiry Pointat MHRA replied, stating that;
“Homeopathy has a long tradition in Europe and homeopathic medicinal products are included in the Medicines Act 1968 and therefore have to be regulated”.
Indeed a European Directive, to be precise Article 1(5) of European Directive 2001/83 EC, defines a homeopathic medicinal product and it was this definition that the author of the Lancet article was mainly concerned with.
The MHRA response went on to say “the [regulation] procedure is regarded as simplified because there is no requirement in the Directive for data to demonstrate clinical efficacy”. Having cleared this one up the MHRA then goes on to tell us that “The Simplified Scheme does not permit therapeutic indications to be stated on the product label and requires the statement ‘Homeopathic medicinal product without approved therapeutic indications’ to be included on the label”.
In the case of homeopathic remedy Arnica, where labelling with therapeutic indications was granted, my colleague was told that the dossier submitted to the Advisory Board on the Registration of Homeopathic products, a part of the MHRA, contained “homeopathic provings… and sufficient evidence to demonstrate that UK homeopathic practitioners would accept the use of the homeopathic product within the homeopathic tradition for the indications sought.” No mention was made of whether this was acceptable to the majority of clinicians, or indeed the general public. If you have not seen “provings” listed in the accepted hierarchy of evidence I suggest you look at the Homeopathic Information Service (www.hominf.org). You will be amazed and hopefully horrified.
Even without a right to label with a therapeutic indication, calling a product “Swine Flu Formula” might give a slight hint as to the indication for use would it not? This product was offered for sale in a pharmacy in Westminster; a region of London not know for its abundance of swine, it is unlikely that the product was being supplied to treat pigs. Indeed, if it were for treatment of swine rather than humans then that raises a whole new list of questions given recent changes in the licensing of veterinary medicinal products. But we won’t go there. It’s quite clear to me having viewed a photograph of the homeopathic medicine bottle that “an indication” was stated.
The story then gets even more bizarre. The MHRA, like Pontius Pilot washing his hands of Jesus, handed the matter over to the body responsible for regulating pharmacists, pharmacy technicians and pharmacies, yes, the Pharmaceutical Society (RPSGB). The MHRA, unable to detect a broken law, perhaps felt that professional misconduct might be the best route to address the problem.
An investigation by the RPSGB concluded that nothing unprofessional had occurred. It seems a shop assistant, someone not on their register, made the supply; nothing therefore to do with the RPSGB and thus no case to answer.
In my view serious issues have been raised by this story. At the start of what could be the worst flu pandemic for 80 years, where the mortality rate could reach 10% of those infected, where is the public protection from charlatans and profiteers? The MHRA failed to stop the product being offered for sale and the RPSGB seem uninterested in what is sold in a pharmacy when sold by a non-registrant. For a regulator charged with the protection of the public this is just not good enough. The question now is will PSNI support the science and rule that pharmacists selling homoeopathic remedies must ensure that patients using them know that they are no more effective than placebo?
