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On 1st September 2006, new regulations allowed homeopathic products to be marketed alongside conventional medicines while exempting them from providing scientific evidence of efficacy. The motivation for these new regulations, according to the Regulatory Impact Assessment of the Medicines and Healthcare products Regulatory Agency (MHRA), was to eliminate old-style licences and to facilitate the expansion of the homeopathic industry in the UK through new products. The changes have been denounced by many doctors and scientists.
"MHRA's new homeopathy regulations in trouble." A critical commentary from Professor David Colquhoun (Dept. Pharmacology, University College London) on the annulment debate which took place in the House of Lords on 26th October 2006. Includes quotations from Lord Taverne, Lord Rees of Ludlow (Martin Rees, President of the Royal Society), The 30th Countess of Mar, Lord Colwyn, and Lord Warner.
States that homeopathy is not evidence-based medicine; that the new Medicines and Healthcare products Regulatory Agency (MHRA) regulations on homeopathic products compromise standards of evidence and clear labelling; that the policy change is damaging to patients' best interests; that evidence-based medicine is essential to public health; that the growth of the homeopathic industry does not contribute to public health; and that rules for the regulation of medicines should not allow homeopathic products to make unsubstantiated health claims. (Sense About Science website) [pdf]
"They [the MHRA] have just utterly betrayed the important job with which they are charged, "ensuring that medicines . . . work", by allowing homeopathic products to be labelled with indications without requiring any evidence that the claims are true (they aren't). The MHRA chief executive, Professor Kent Woods, should be fired immediately for dereliction of the duty of the MHRA to protect the public from medicines that don't work." Critical comments from David Colquhoun, FRS, A. J. Clark Professor of Pharmacology, University College London. He also reveals that the MHRA group responsible for advising on whether or not medicines work consists of one pharmacologist, one psychiatrist, a representative an organisation devoted to "crackpot medicine", a nurse and three accountants/bankers/marketers with strong industry connections (the members are identified).
"The Biosciences Federation supports policy-making underpinned by sound scientific evidence, therefore the MHRA's decision to accept homeopathic 'provings' as data on efficacy is of extreme concern to the Federation. The new regulations do not comply with the MHRA's duty to ensure the safety and efficacy of medicines, and to provide clear, honest advice to the public. It is vital that the decisions of regulatory bodies are free form political, special interest, or media influence, and that they are based on the best available evidence. In this case it would seem that the MHRA has bowed down to industry pressure." [pdf]
Critique of the second oral evidence session of the House of Commons Science and Technology Committee held on 30th November 2009. Majikthyse blogspot (9th December 2009)
Critique of the oral session for the evidence check on homeopathy, called by the House of Commons Science and Technology Committee. Majikthyse blogspot (26th November 2009)
"Why the MHRA do not prosecute for straightforward fraudulent trading I just do not know." The Quackometer (2nd September 2009)
"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." David Colquhoun, DC Science (11th June 2009)
The Government's Chief Scientific Adviser, John Beddington, criticises the use of homoeopathy within the National Health Service. Article by Zoë Corbyn, Times Higher Education (20th May 2009)
"…the license comes despite experts saying there is no evidence the product has any benefit." Article by Nigel Praities, Pulse (12th May 2009)
Giving evidence to the Commons innovation, university and skills committee, Sir David King (UK government Chief Scientific Adviser) said anyone relying on homeopathic remedies to treat a serious health problem risked doing more harm than good. Sir David told MPs: "There is not one jot of evidence supporting the notion that homeopathic medicines are of any assistance whatsoever. Therefore I would say they are a risk to the population because people may take them expecting they are dealing with a serious problem." He added concerns that the Medicines Health and Regulatory Authority allows homeopathic remedies to be labelled with what ailments they will treat, with little scientific evidence backing up the claims. Sir David said: "How can you have homeopathic medicines labelled by a department which is driven by science?" politics.co.uk (7th December 2007)
A critical commentary on the MHRA's new homeopathy regulations by Les Rose, Consultant in Clinical Science, Biologist (1st February 2007) [Adapted for Healthwatch with the publication's permission]
"The Physiological Society is concerned with the scientific investigation of how the body works…It is our view that "alternative medicine" has, with very few exceptions, no scientific foundation, either empirical or theoretical. As an extreme example, many homeopathic medicines contain no molecules of their ingredient, so they can have no effect (beyond that of a placebo). To claim otherwise it would be necessary to abandon the entire molecular basis of chemistry. The Society believes that any claim made for a medicine must be based on evidence, and that it is a duty of the regulatory authorities to ensure that this is done." Comment on the MHRA's new regulations from The Physiological Society, Physiology News No.65 (Winter 2006) [pdf]
More critical comments on the MHRA's new regulations from James Randi. (3rd November 2006)
"Homeopathic remedies are now allowed to indicate what sort of symptoms they can relieve, although this is limited to minor ailments such as colds, coughs and hay fever. But under the rules, manufacturers don't have to provide evidence of efficacy from clinical trials and need to show any that the product has been used to treat those particular conditions within the homeopathic industry. Which? Health policy expert Frances Blunden warned "This approach gives homeopathic products the veneer of efficacy. Claims for any homeopathic products ought to be based on independently verified and reliable evidence of their efficacy. Without this there's a danger that consumers are being misled and ultimately ripped off. Consumers shouldn't be fooled that despite homeopathic medicines being 'alternative' there is still a significant profit-making industry behind them"." Which? (26th October 2006)
"With these new rules, for the first time in its history the regulation of medicines has moved away from science and away from clear information for the public. The College is deeply alarmed by these developments… the endorsement of such therapies without appropriate pre-clinical tests and clinical trials and without rigorous safety and efficacy data may encourage patients to use them as an alterative to conventional treatments. We do not believe that this is in the patient's best interests." Professor Adrian Newland, President, The Royal College of Pathologists (22nd October 2006) [pdf]
Critical comments from James Randi on the MHRA's licensing of homeopathic remedies. (22nd September 2006)
"The MHRA has accepted homeopathic 'provings' as evidence of efficacy in order to protect the commercial interests of the homeopathic industry, and with disregard for the truth, or the health interests of the public. It was under no obligation to do so." Professor John Garrow, Vice-chairman of Health Watch (18th September 2006) [pdf]