What alternative health practitioners might not tell you

Are UK homeopaths abiding by these rules on advertising Homeopathic Registration products?

See page 22. [pdf]

The MHRA's list of licenced homeopathic products [pdf]

MHRA — promoting homeopathy

"Here we have a completely ludicrous system of medicine that does not work, a government regulatory agency which is meant to ensure that medicines are not only safe but that they work, and yet that very government agency is not only supporting, but promoting, the use of bogus medicine!" John Jackson (UK Skeptics)

MHRA’s draft guidance on advertising homeopathic medicines

Designed to “provide clarity about the rules governing the advertising of homeopathic medicines licensed under the three regulatory schemes available”.  (2nd March 2011)

Pretending that evidence is difficult and complicated

“At midnight last night, the Medicines and Healthcare Regulatory Authority closed its consultation on how they should label homeopathy sugar pills without misleading the public. You may not think this is a difficult task, but politics makes it so.   To recap: homeopathy pills don’t work better than placebo dummy pills in trials. They are made by taking one drop of the original substance and diluting it in...

1,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000, 000,000,000,000 drops of water

...then taking one drop of that solution, which is now just water, and shaking it near some pills, which you then buy to treat an illness.  Current MHRA wording says: “a homeopathic medicinal product used within the homeopathic tradition for the treatment of [whatever condition]”. Homeopaths like this because it’s ambiguous. Their internal lobbying document (which I have helpfully posted on the internet for everyone to read), explains that this wording “avoids the need to prove the science” and so “allows us to practise as normal”. 

Can the MHRA walk the line between evidence, politics, and clarity? Quack remedies are in their own world of silliness, but we are entitled to have higher expectations of regulators, since they themselves expect to be taken more seriously.”  Ben Goldacre, Bad Science (19th February 2011)

Write the MHRA label for homeopathy - a science communication challenge

The results of Ben Goldacre’s invitation to members of the public to write the label better than MHRA - see comments section. Ben Goldacre’s Posterous (17th February 2011)

Pseudo-regulation: another chance to save the MHRA from looking idiotic

"The Medicines and Health Regulatory Authority (MHRA), has just launched yet another consultation…The consultation concerns what should be done, about homeopathy in the wake of the scarifying report of the House of Commons Select Committee, and the government’s response to that report...More honest labelling was about the only sensible thing recommended by the Government’s response. On this topic the MHRA proposals verge on the laughable. At present the labelling allowed under the NRS includes:

“A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of ...”

It is proposed to change this to:

“A homeopathic medicinal product licensed only on the basis of safety, quality and use within the homeopathic tradition”

“A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of…”

Spot the difference!

The is utterly inadequate. In fact it verges on the pathetic (and on the dishonest)…Why, oh why, cannot the MHRA bring itself to simply tell the truth? It seems to be so stifled by some perversion of political correctness that it is unable to do what it must know is right.”

Professor David Colquhoun, DC Science (26th January 2011)

The MHRA and the Labeling of Homeopathic Products

“The MHRA say they test the public's understanding of homeopathic labeling; they do not such thing…The MHRA appear to completely miss the point over homeopathy. As I have written before, they fail twice over. Firstly, they endorse misleading labels on homeopathic products and fail in their primary mission to “ensure that medicines and medical devices work.” Secondly, they appear to be blind to the blatant abuses that do go on in the creation of homeopathic medicines where claims are made explicitly and implicitly without even seeking MHRA approval. The mistake that all regulatory efforts from this government has made is to attempt to regulate alternative medicines as if they were medicines. They are not: they are pseudo-medicines and need a different style of thinking. Trading Standards should take a more leading role in prosecuting misleading claims as they would with any other consumer product. The MHRA need to stop feeling they need to treat homeopathy as if it were medicine and give special dispensations in the claims that they can make. As with any other medicine, homeopathy should only be allowed to make claims if they can back them up with sound evidence.” The Quackometer (15th January 2010)

The Three Amigos

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)

Evidence: It's whatever you want it to be

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)

The MHRA and their Double Failure over Homeopathy

"Why the MHRA do not prosecute for straightforward fraudulent trading I just do not know." The Quackometer (2nd September 2009)

MHRA publish public assessment of homeopathic arnica, admit it does nothing, but license it anyway

Thinking Is Dangerous blogspot (1st July 2009)

The Medicines and Health Regulatory Authority breaks the law?

"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)

Licence to homeopathic remedy 'makes mockery of medicines watchdog's own rules'

Article by Kate Devlin, Medical Correspondent, Telegraph (10th June 2009)

Chief scientist takes a stand

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)

Arnica pill the first homeopathic remedy to get MHRA licence

"…the license comes despite experts saying there is no evidence the product has any benefit." Article by Nigel Praities, Pulse (12th May 2009)

Government support for homeopathy 'risking lives'

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)

British health care regulation moves away from science

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]

Homeopathic 'mumbo-jumbo'

"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]

Relaxing the rules

More critical comments on the MHRA's new regulations from James Randi. (3rd November 2006)

UPDATE: 27th October 2006

"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.

Doctors hit out at homeopathy move

"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)

MHRA Press Release: National Rules Scheme for homeopathic medicines

Statutory Instrument 2006 No.1952

The Medicines for Human Use (National Rules for Homeopathic Products) Regulations 2006 [pdf]

The Medicines for Human Use (National Rules for Homeopathic Products) Regulations 2006

Explanatory memorandum [pdf]

Critical comments on the new regulations

From Professor Michael Baum (Emeritus Professor of Surgery, University College London), Dr Evan Harris MP (Liberal Democrat Science Spokesman), Professor David Colquhoun (Professor of Pharmacology, University College London), Professor Edzard Ernst (Professor of Complementary Medicine, University of Exeter), Professor Gustav Born (Emeritus Professor of Pharmacology, Kings College London), Professor John Garrow (Emeritus Professor of Human Nutrition, University of London), and Tracey Brown (Director, Sense About Science). Comments published by Sense About Science.

Statement on Evidence-Based Medicine and The Medicines for Human Use (National Rules for Homeopathic Products) Regulations 2006

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]

Friends In High Places'

"…..the MHRA, and the bodies that came before it, are serious regulatory bodies that are engaged in serious business, checking that medicines are safe, and that pharmaceutical companies do not make unreasonable claims. They brought in the Yellow Card System as a response to things like Thalidomide. And here their credibility is, in my mind, undermined. This change will be exploited by quacks to suggest that their treatments have received tacit endorsement, as has happened many times before." A critical commentary on the new regulations from Ben Goldacre, MD (Bad Science)

'The MHRA breaks its founding principle: it is an intellectual disgrace'

"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).

Comment on The Medicines for Human Use (National Rules for Homeopathic Products) Regulations 2006 from the Biosciences Federation

"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]

MHRA Regulations on homeopathic products

"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]

A win for quackery in the UK'

Critical comments from James Randi on the MHRA's licensing of homeopathic remedies. (22nd September 2006)

The Medicines for Human Use (National Rules for Homeopathic Products) Regulations

"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]

Fears over homeopathy regulation

"Patients will be put at risk by a new regulatory system being brought in for homeopathic medicine, critics say. The Medicines and Healthcare products Regulatory Agency (MHRA) is introducing rules to allow remedies to specify the ailments for which they can be used. But critics argue the treatments will not be rigorously tested as they do not need to undergo the clinical trials orthodox drugs do to get a licence." BBC News (1st September 2006) [Includes a video link entitled "How the new labelling system will help customers".]

Homeopathic licensing alarms doctors

"Packaging on homeopathic products will be allowed to describe the illnesses they claim to be able to treat under a controversial licensing scheme introduced by the government today. The National Rules System is designed to bring homeopathic remedies into line with licensed medicines — but doctors and scientists say it will legitimise products that have no scientific evidence to support their claims." Alok Jha, science correspondent, The Guardian (1st September 2006)

Doctors attack natural remedy claims

"Regulations on homoeopathic remedies that come into force today have infuriated scientists and doctors. For the first time, homoeopathic treatment will be allowed to claim efficacy measured by their own methods, not by the much tougher standards applied to conventional medicines, and will be able to list on their labels what conditions they are supposed to treat." Nigel Hawkes and Mark Henderson, Timesonline (1st September 2006)