Evidence Check 2: Homeopathy - Homeowatch

Evidence Check 2: Homeopathy 33Our expectation is that being “fully informed” requires the consumer to have anunderstanding of the content and efficacy of the homeopathic product and, moreover, notto be misled by the label. Therefore we would expect user-testing of labels for homeopathicproducts to test whether the participants could determine from the label that:• the product did not contain any active ingredient (or contained only a few molecules);and• the product was not proven to be efficacious in the treatment of any medical complaint.The Evidence CheckEvidence of efficacy123. In Chapter 2 we reached the conclusion that homeopathy was not efficacious and anyperceived effectiveness was in fact solely due to the placebo effect. When we took oralevidence from Professor Woods, Chief Executive of the MHRA, we asked his view on theefficacy of homeopathy and he responded:One has to look at the totality of the evidence and in my view there is no single pieceof evidence that gives that reassurance. […] In aggregate I do not think there isanything there that one would take as robust evidence of an effect over and above theplacebo effect. 146124. Professor Woods claimed that the MHRA does not seek evidence of efficacy under theNRS 147 yet the MHRA’s guidance on the NRS states:The applicant must submit data on the efficacy of the product which is the subject ofthe application. 148The guidance continues:It should be noted that results of clinical trials are not required to supportapplications for marketing authorizations under the National Rules Scheme.However, the applicant must provide one or more of the following:• Study reports in relation to the product which is the subject of the application;• Published scientific literature;• Homeopathic provings. 149125. The RPSGB expressed concern that “homeopathic literature can be used as evidencefor medical claims despite the fact that it may not have been subjected to the same level145 Ev 63, para 31146 Q 182147 Qq 227–28148 “The Homeopathic National Rules Scheme: Brief Guidance for Manufacturers and Suppliers”, Medicines andHealthcare products Regulatory Agency, 2006149 As above