Friday, 22 September 2017

EASAC statement on Homeopathy

Here, dated September 2017:
EASAC – the European Academies' Science Advisory Council – is formed by the national science academies of the EU Member States to enable them to collaborate with each other in giving advice to European policy-makers. It thus provides a means for the collective voice of European science to be heard.
EASAC, the European Academies’ Science Advisory Council, is publishing this Statement to build on recent work by its member academies to reinforce criticism of the health and scientific claims made for homeopathic products. The analysis and conclusions are based on the excellent science-based assessments already published by authoritative and impartial bodies. The fundamental importance of allowing and supporting consumer choice requires that consumers and patients are supplied with evidence-based, accurate and clear information. It is, therefore, essential to implement a standardised, knowledge-based regulatory framework to cover product efficacy, safety and quality, and accurate advertising practices, across the European Union (EU).
Our Statement examines the following issues:
Scientific mechanisms of action—where we conclude that the claims for homeopathy are implausible and inconsistent with established scientific concepts.
Clinical efficacy—we acknowledge that a placebo effect may appear in individual patients but we agree with previous extensive evaluations concluding that there are no known diseases for which there is robust, reproducible evidence that homeopathy is effective beyond the placebo effect. There are related concerns for patient-informed consent and for safety, the latter associated with poor quality control in preparing homeopathic remedies.
Promotion of homeopathy—we note that this may pose significant harm to the patient if incurring delay in seeking evidence-based medical care and that there is a more general risk of undermining public confidence in the nature and value of scientific evidence.
Veterinary practice—we conclude similarly that there is no rigorous evidence to substantiate the use of homeopathy in veterinary medicine and it is particularly worrying when such products are used in preference to evidence-based medicinal products to treat livestock infections.
We make the following recommendations.
1. There should be consistent regulatory requirements to demonstrate efficacy, safety and quality of all products for human and veterinary medicine, to be based on verifiable and objective evidence, commensurate with the nature of the claims being made. In the absence of this evidence, a product should be neither approvable nor registrable by national regulatory agencies for the designation medicinal product.
2. Evidence-based public health systems should not reimburse homeopathic products and practices unless they are demonstrated to be efficacious and safe by rigorous testing.
3. The composition of homeopathic remedies should be labelled in a similar way to other health products available: that is, there should be an accurate, clear and simple description of the ingredients and their amounts present in the formulation.
4. Advertising and marketing of homeopathic products and services must conform to established standards of accuracy and clarity. Promotional claims for efficacy, safety and quality should not be made without demonstrable and reproducible evidence.

Our purpose is not to seek the prohibition of homeopathic products, and we recognise the fundamental importance of allowing and supporting consumer choice. Rather, we aim to explore the policy dimensions for ensuring informed patient choice with the emphasis on ‘appropriately informed’, and for achieving a standardised knowledge-based, robust regulatory framework and sound advertising practices across the EU, which can apply equitably to all medicinal products, whatever their origins and whatever their mechanisms.

The continuing popularity of homeopathic products worldwide might be taken as demonstrating an unfortunate point – that scientific evidence is not always relevant to the policy maker nor understood by the public-at-large. In this eventuality, there might be only limited room for optimism that EASAC and others – in reiterating that homeopathic products and practices lack proof of efficacy– could influence the present situation. 

Any claimed efficacy of homeopathic products in clinical use can be explained by the placebo effect or attributed to poor study design, random variation, regression towards the mean, or publication bias. Among these, the placebo effect can be of value to the patient but there are no known diseases for which there is robust, reproducible evidence that homeopathy is effective beyond the placebo effect.
• Homeopathy raises issues of concern for patient-informed consent if health practitioners recommend products that they know are biologically ineffective.
• There are also potential safety concerns for homeopathic preparations because of poorly monitored production methods, and these require greater attention to quality control and assessment of adverse effects.
• The scientific claims made for homeopathy are implausible and inconsistent with established concepts from chemistry and physics. In particular, the memory effects of water are too short-range and transient (occurring within the nanometre and nanosecond range) to account for any claimed efficacy.
• The promotion and use of homeopathic products risks significant harms. First, by incurring delay in the patient seeking appropriate, evidence-based, medical attention or, even worse, deterring the patient from ever doing so. Secondly, by generally undermining patient and public confidence in the nature and value of scientific evidence for decision making in health care and other societal priorities.
• In the absence of similarly robust evidence for homeopathic products in veterinary medicine, it is an error to require organic farmers to use these products in preference to prevention or treatment for which there is demonstrable efficacy and an established mode of action.


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