Intended for healthcare professionals

Views & Reviews No Holds Barred

How the UK drug regulator became the herbalists’ marketeer

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3194 (Published 09 May 2014) Cite this as: BMJ 2014;348:g3194

This article has a correction. Please see:

  1. Margaret McCartney, general practitioner, Glasgow
  1. margaret{at}margaretmccartney.com

Devil’s claw, arnica flower, palmetto fruit, and feverfew are among herbs recently endorsed as meeting standards of “safety, quality, and efficacy” by the Medicines and Healthcare Products Regulatory Agency (MHRA).1 Yes: the supposedly serious governmental regulator of drugs and devices in the United Kingdom has approved the use of a bunch of non-evidence based interventions.2

But devil’s claw (harpagoside) has not been shown to be effective or safe for long term use.3 Evidence is insufficient to back the use of arnica,4 and if it does work it is likely to have more side effects than topical ibuprofen.5 Palmetto does not improve the urinary symptoms for which the agency allows it to be used.6 And there is not enough evidence that feverfew can improve migraine.7

The regulator’s bizarre test for herbal medicines is not the randomised controlled trial that you would expect, designed to show effectiveness and side effects. No, the “normal requirement for medicines to be proven to be efficacious” is instead “replaced by a requirement to demonstrate 30 years’ traditional use for the required indication.”

This means simply that the herbs have been around for the past few decades and that the regulator will accept “testimony of recognised experts on herbalism” as proof of their effectiveness.8 Any real expert would tell the MHRA that eminence is a poor sort of evidence.

The agency started approving ineffective remedies to stay within European law, in a move that it said would “remove the differences which create obstacles to the free movement of medicinal products in the European Union, while ensuring protection for public health.”9 Really?

Despite the regulator’s claim that it aims to “protect and improve the health of millions of people every day” through regulation “underpinned by science and research,”10 this licensing double standard means people may well be misled into thinking that the herbal products the MHRA approves might work when they don’t—wasting time, effort, and taxpayers’ money.

Worse, it teaches two standards of evidence. How can the regulator use the criteria of tradition alone for one type of healthcare (herbal medicines) while applying a completely different set of criteria based on clinical trials for everything else?

The truth is that it doesn’t matter whether something is picked under a full moon from an organic field, or produced in a chemical factory. The standards that we should expect of the MHRA’s approved healthcare interventions should be the same, regardless of their provenance. It’s simply not good enough to approve an intervention because it happens to be old, rather than because it works.

Notes

Cite this as: BMJ 2014;348:g3194

Footnotes

  • Competing interests: I have read and understood the BMJ Group policy on declaration of interests and declare the following interests: I am an NHS GP partner, with income partly dependent on QOF points. I am a part time undergraduate tutor at the University of Glasgow. I have authored a book and earned from broadcast and written freelance journalism. I am an unpaid patron of Healthwatch. I make a monthly donation to Keep Our NHS Public. I am a member of Medact. I am occasionally paid for time, travel, and accommodation to give talks or have locum fees paid to allow me to give talks, but never for any drug or public relations company. I was elected to the national council of the Royal College of General Practitioners in 2013.

  • Provenance and peer review: Commissioned; not externally peer reviewed.

  • Follow Margaret McCartney on Twitter, @mgtmccartney

References