Senior Scientist Cautions On The Label For Homeopathic Product

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Main Category: Complementary Medicine / Alternative Medicine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 12 Jun 2009 - 7:00 PDT

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In a letter published in this week´s BMJ, Professor David Colquhoun from the University College of London, says that the UK Medicines and Health Care Products Regulatory Agency (MHRA) "has made a mockery of its own aims" by allowing the labeling on the first homeopathic product that has gotten a license. It classifies the Arnica 30C pills as "a homoeopathic medicinal product used with the homoeopathic tradition for the symptomatic relief of sprains, muscular aches, and bruising or swelling after contusions". He claims this label should be illegal because it breaches the Unfair Trading Regulations.

Further on, Dr. Colquhon continues by stressing the point that the pills contain no trace whatsoever of the ingredient on the label. This dishonest behavior is how Arnica 30C manufacturers have gotten their way around for a long time through a legal loophole. As an example, he mentions that if someone sells strawberry jam that contained no trace of strawberries, that person would be deceiving customers and would surely get in trouble.

He sees no ambiguity that could allow the manufacturers of Arnica 30C to dodge the consumer protection laws which specifically ban "falsely claiming that a product is able to cure illnesses" and which apply to the way "the average consumer" understands the labels.

The typical buyer is unlikely to know that when using the terms "used with the homoeopathic tradition" the manufacturers are playing with the words which actually mean "there isn't a jot of evidence that the medicine works," he argues.

Further more, the legality of the labeling that the MHRA has approved cannot be substantiated since there is no evidence that Arnica 30C provides symptomatic relief of sprains, etc…

In support to these statements, Professor Stephen Evans from the London School of Hygiene and Tropical Medicine mentions that the MHRA could have waited in granting the license due to the reason that there is "good evidence against efficacy".

Professor Evans continues by warning that this product "may have major indirect harms, not only in individual patients who may not get benefit from the other effective remedies but also in a general sense by undermining the rational basis for medicine." All this mess about false labeling, he says, takes us back to the days before drug regulation was introduced, and partly to prevent hazards of snake-oil type remedies.

In a final letter, Nicholas Moore, a clinical pharmacologist at the University of Bordeaux says that "giving homoeopathy credit for any kind of demonstrable efficacy is ludicrous."

But Doctor Moore indicates that homoeopathy might be helpful as "a truly inactive placebo" for over-treated illnesses such as the common cold and insomnia. This "will not alter the course of the disease. But the patient will feel better, which is one of the aims of medicine's art, if not its science," he concludes.

"MHRA label seems to be illegal"
David Colquhoun
BMJ 2009; 338:b2333

"Back to square one"
Stephen J Evans
BMJ 2009; 338:b2332

"Being useless may be useful"
Nicholas Moore
BMJ 2009; 338:b2334
bmj.com

Written by Stephanie Brunner (B.A.)
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