Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
This is another short interruption in the epic self-destruction of chiropractors. In a sense it is more serious. One expects quacks to advocate quackery. What you don’t expect is that the National Institute of Clinical Excellence (NICE) will endorse it. Neither do you expect the Medicines and Healthcare products Regulatory Agency (MHRA) to betray its mandate to make sure that medicines work.
The saga of the NICE low back pain guidance has been the subject of a deluge of criticism, It seems doubtful that the guidance can survive, not least because of its absurd endorsement of chiropractic, at a time when chiropractic is undergoing self-immolation as a consequence of the persecution of Simon Singh by the British Chiropractic Association (see here, and here, and here, and here and thousands of other sites).
The other betrayal has come to the for after the MHRA approved highly misleading labelling of a homeopathic preparation. At the time,
in 2006, when the principle was approved by the MHRA, just about every scientific organisation, even the Royal Society, condemned the action. What was discouraging that the clinical organisations all stayed silent. It is still a mystery why the MHRA made this enormous mistake, Some said that European regulations required it, but that is quite untrue, as Les Rose has shown. It appears to have been the result of a pusillanimous MHRA bowing to pressure from a deeply unscientific Department of Health (a letter from Caroline Flint at the time borders on the surreal).
On 20 May 2009, the British Medical Journal printed an article Drugs agency grants its first licence to homoeopathic product by Deborah Cohen (available free). The comments were mostly highly critical of the MHRA. The BMJ asked, as it does from time to time, for my comment to be converted to a letter
for the print edition. That isn’t freely available, so here it is.
|
Published 9 June 2009, doi:10.1136/bmj.b2333 LettersHomoeopathic product licenceMHRA label seems to be illegalThe strap line for the Medicines and Healthcare products Regulatory Agency (MHRA) is “We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe.” Yet the MHRA has made mockery of its own aims by ignoring the bit about “ensuring that medicines work” and allowing Arnica 30C pills to be labelled: “a homoeopathic medicinal product used within the homoeopathic tradition for the symptomatic relief of sprains, muscular aches, and bruising or swelling after contusions.”1 This label should be illegal anyway because the pills contain no trace of the ingredient on the label, but this deceit has been allowed through a legal loophole for a long time now. If you sold strawberry jam that contained not a trace of strawberry you’d be in trouble. But I can see no legal loophole that allows the manufacturers of Arnica 30C to evade the provisions of the Consumer Protection from Unfair Trading Regulations 2008. One of the 31 commercial practices which are in all circumstances considered unfair is “falsely claiming that a product is able to cure illnesses, dysfunction, or malformations.” The consumer protection laws apply to the way that “the average consumer” will interpret the label. The average consumer is unlikely to know that “used within the homoeopathic tradition” is a form of weasel words that actually means “there isn’t a jot of evidence that the medicine works.” Since there is not the slightest evidence that Arnica 30C pills provide symptomatic relief of sprains, etc, the labelling that the MHRA has approved seems to be illegal. The MHRA is not selling anything itself, so I presume that it won’t find itself in court, but anyone who follows its advice could well do so. Cite this as: BMJ 2009;338:b2333 David Colquhoun, research professor1 University College London, London WC1E 6BT Competing interests: None declared. References |
It is, I suppose, just a sign of the chaos that reigns in the multiple agencies and quangos responsible for ‘regulation’ that one arm of government proposes action that a different branch would consider illegal. That is an inevitable consequence of trying to regulate something without first deciding whether it is nonsense or not. The Department of Health appears to be quite incapable of grasping this simple and obvious fact.
Follow-up
Health: best treatments. The Guardian seems to the be picking up BMJ stories and ran this one.
7 Responses to The Medicines and Health Regulatory Authority breaks the law?
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All that is needed now is a friendly Trading Standard officer wanting to test this out.
Quite. Working on that one.
Unfortunately, though, Trading Standards Offices mostly seem to be ill-equipped to deal with enforcement of the law. One TS officer recently told me (apropos of a different case) that if all the changes to claims were made there would be no business left. He seemed to regard this as a reason for doing very little.
David
We could report all the bottles of Arnica 30C to the MHRA as counterfeit. There is a convenient place on their website, see:
http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Adviceandinformationforconsumers/Counterfeitmedicinesanddevices/index.htm
[…] to Professor David Colquhoun, yes, it is. You must read his letter to the British Medical Journal regarding the MHRA’s decision to register Nelsons Arnicare […]
David,
Further to your link to the Guardian story, you may be interested to know that the BMJ Group runs a news service for the public, which is published by the Guardian.
Declaration of interest: employee of the BMJ group and writer of the story in question. Thanks for the link!
Philip
Ah good. I guess ‘Do alternative treatments really work for back pain?‘ is part of the same series. I thought that was quite good on the evidence, but ignored entirely the secondary consequences that will follow if alternative, and not very effective, treatments like acupuncture and chiropractic are given a stamp or respectability.
[…] for any of the indications on the label” (10). Arguably, the MHRA is in breach of Consumer Protection law (11, […]