The MHRA’s new policy towards CAM has already received a well-deserved drubbing in the House of Lords. Now have the first example of the MHRA allowing totally misleading labels to be put on over-the-counter treatements.
A press release dated November 8th 2006 gives the shocking news.
MHRA grants landmark registration for Traditional Herbal Medicine
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted the first UK product registration under the European Directive on traditional herbal medicinal products.
Professor Kent Woods, Chief Executive of the MHRA said:“This first product registration is an important landmark. We hope that Atrogel Arnica Gel will be the first of many products to receive a traditional herbal registration. Our aim is to enable those consumers who wish to take herbal medicines to make an informed choice from a wide range of products which have been made to assured standards of safety, quality and patient information.”
What is the evidence that Arnica Gel does the slightest good for the conditions that will appear on the label? The answer is essentially none. There are only two papers in Medline. The first shows no detectable effect of arnica gel (compared with vehicle alone) (Alonso D, Lazarus MC, Baumann L., Effects of topical arnica gel on post-laser treatment bruises. Dermatol Surg. 2002 Aug;28(8):686-8.)
The second paper claims a positive effect, but it is worthless because it was an open trial with no proper controls. (Knuesel O, Weber M, Suter A. Arnica montana gel in osteoarthritis of the knee: an open, multicenter clinical trial. Adv Ther. 2002 Sep-Oct;19(5):209-18.). The last author on this paper, incidentally, gives his address as Bioforce AG.
So yes, the MHRA’s press release is indeed a landmark. It is the first time that they have allowed a medicine to be labelled with a therapeutic claim when there is no reason to believe it to be true.
The bottom of the press release says (my emphasis) “The MHRA is the government agency that is responsible for ensuring that medicines and medical devices work, . . .”.
Uhm, surely some inconsistency there.
But no, Kent Woods tells me “The strap-line you refer to is a highly simplified statement of our role in making regulatory judgements based on risk/benefit analysis in the real world. ”
The bizarre behaviour of the MHRA is based on European Directive 2004/24/EC.This contains (para 6) the following prime example of pre-enlightenment thought.
â€œThe 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.â€
Evidently the MHRA have decided to go along with the licence for snake-oil salesman that this provides. It isn’t clear that they were compelled to do so (MHRA’s response here).
This is what the packet looks like. On the right, one panel is enlarged. The claim “It helps relieve symptoms including:” is quite outrageous. There isn’t the slightest reason to believe anything of the sort. I know the bit above that says “based exclusively on long-standing use”, but it certainly won’t be obvious to most shoppers that this is meant to imply that the clear claim that “it helps to relieve symptoms” may be so much nonsense.