Intended for healthcare professionals

News

Drugs agency grants its first licence to homoeopathic product

BMJ 2009; 338 doi: https://doi.org/10.1136/bmj.b2055 (Published 20 May 2009) Cite this as: BMJ 2009;338:b2055
  1. Deborah Cohen
  1. 1BMJ

    The United Kingdom’s drugs agency has given a licence to the makers of a homoeopathic product, despite scientists and researchers saying that no evidence shows that it works.

    Since September 2006 the Medicines and Healthcare Products Regulatory Agency (MHRA) has been allowed to grant licences to traditional therapies if their use “is plausible on the basis of long standing use and experience” and no evidence shows that they cause harm.

    At the end of last month, Nelsons Arnicare Arnica 30c pillules became the first product in the UK to be given such a licence by the agency, which will enable its manufacturers to make therapeutic claims for it.

    Edzard Ernst, the UK’s only professor of complementary medicine, said that the agency’s national rules scheme was “making a mockery of evidence based medicine.”

    On the packaging, the makers will be able to describe the product as “a homoeopathic medicinal product used within the homoeopathic tradition for the symptomatic relief of sprains, muscular aches, and bruising or swelling after contusions.”

    Professor Ernst says that the remedy based on the plant Arnica montana has been subject to more controlled clinical trials than any other homoeopathic treatment.

    “There is no good evidence for arnica,” he said. “It is so very ironic that arnica should be the first with a licence able to claim therapeutic benefits for things [for] which it doesn’t work or there’s no evidence for.”

    Two independent systematic reviews of homoeopathic arnica found no evidence that it was clinically more effective than placebo. A 1998 systematic review published in the Archives of Surgery concluded, “The claim that homoeopathic arnica is efficacious beyond placebo effect is not supported by rigorous clinical trials” (1998;133:1187-90).

    The next year Carstens-Stiftung, a German foundation dedicated to the “promotion and support of complementary medicine,” conducted a systematic review that found that there was “no clear evidence in favour of homoeopathic arnica” (www.carstens-stiftung.de/wissen/hom/pdf/klin_wilkens_jb5.pdf).

    Professor Ernst added that no trial conducted after 1999 has been robust enough to undermine the conclusions of the two previous systematic reviews.

    Describing the regulation for homoeopathic products as “balmy,” Professor Ernst is concerned about lack of a need to provide rigorous data on the efficacy of homoeopathic products.

    However, according to the drugs agency the results of clinical trials are not required to support applications for marketing authorisation under the national rules scheme.

    Guidance for the manufacturers of homoeopathic products says, “Because of the philosophy of homoeopathy and the nature of the products, it is difficult to establish efficacy for homoeopathic products by way of clinical trials.”

    Instead it requires reports to “sufficiently demonstrate that UK homoeopathic practitioners would accept the efficacy of the product for the indications sought.”

    The guidance also states that indications are limited to the relief or treatment of minor symptoms or minor conditions because “the rules do not require rigorous clinical data.”

    A spokesperson for the agency said that as “the applicant [Nelsons] was able to meet the above mentioned criteria for their application, the indication was accepted.”

    The national rules scheme is based on a 2001 European Directive, which said, “The long tradition of the medicinal product makes it possible to reduce the need for clinical trials, in so far as the efficacy of the medicinal product is plausible on the basis of long-standing use and experience. Pre-clinical tests do not seem necessary, where the medicinal product on the basis of the information on its traditional use proves not to be harmful in specified conditions of use.”

    When the scheme was first announced in 2006, many academics and societies, including the Royal Society, the Medical Research Council, and the British Pharmacological Society, raised concern about the implications for evidence based medicine and science.

    “I suspect there are very powerful lobby groups, who might have argued that homoeopathic treatments cannot be tested for efficacy in the conventional way. I don’t believe to be true,” Professor Ernst said pointing to the fact that there are over 200 clinical trials of homoeopathic remedies. “Sadly, these trials don’t support what homoeopaths believe.”

    Other academics and organisations have joined Professor Ernst in criticising the scheme. Simon Maxwell, from the British Pharmacological Society, says that the products under the national rules scheme have not been submitted to the same scrutiny and efficacy that other medicinal products have been through.

    “The national rules scheme simply doesn’t apply the rigorous standards of testing that apply to other conventional medicinal products that are licensed to be prescribed by health professionals or sold by pharmacists,” he said.

    However, the scheme has got broad support from the homoeopathy industry. Robert Wilson, chairman of Nelsons, said, “The fact that therapeutic indications may now be included on the packaging of licensed homoeopathic medicines not only opens the practice of homoeopathy up to new users but also gives it added credibility as a safe and natural complement to conventional medicine.”

    A spokesperson for the drugs agency agreed: “We feel that our work benefits both the general public, by strengthening the public health protection of users of homoeopathic medicinal products, and the homoeopathic industry by levelling the playing field and increasing the range of products that can be marketed.”

    But the willingness of the agency to grant licences for such products concerns David Colquhoun, professor of pharmacology at University College London. “The MHRA is not doing its job. They are supposed to regulate quality, safety, and efficacy,” he said. “The MHRA are giving products credibility that don’t have the necessary evidence base to back them up.”

    In a letter to Professor Colquhoun in 2007, the agency admitted that there was no evidence that many herbal medicines work. “The vast majority of herbal products currently on the UK market without claims are of unproven benefit,” it said.

    Professor Colquhoun commented, “The products are supposed to say ‘used in the tradition.’ But will the average consumer really understand this? They are weasel words that will be taken by the consumer that a product works,” he added.

    “What’s more I don’t think it’s the job of the MHRA to support any type of industry,” he said.

    Notes

    Cite this as: BMJ 2009;338:b2055

    View Abstract