Memorandum submitted by Dr Andy Lewis HO 11

 

Government policy on licensing of homeopathic products  

1. Currently, the licensing of homeopathic products is not made on the basis of evidence. This is in stark contrast to how other medicinal products are licensed in this country. Indeed, it would only be possible to give MHRA licenses to homeopathic products if the requirement of evidence of efficacy were dropped as these products are not medicinal products but pseudomedical products based on magical thinking and pre-scientific ideas.

2. The MHRA allow sellers to submit evidence from homeopathic 'provings' as evidence. A proving is where a homeopath takes a new type of homeopathic pill to see what symptoms it generates. Homeopaths believe 'like cures like', so an onion, which makes your eyes stream, can cure hayfever - allegedly. However, homeopathic pills have been so diluted that no ingredients actually remain. What homeopaths 'prove' is plain sugar pills - any symptoms they note are either coincidental or imaginary. There is no good evidence to sugges that homeopathic proving are a reliable means of generating a homeopathic 'symptom picture'. The largest ever controlled homeopathic proving showed that there were no observable effects.[1] This is consistent with proving being nonsense and MHRA rules relying on nonsense methods to show efficacy.

3. Despite the regulations, many homeopathic pharmacists continue to sell homeopathic pills with specific indications without a license. To test this, last year, visited London's Nelson's Homeopathic Pharmacy just off Oxford Street. I went in and said I needed something for an upset stomach and that I had diarrhoea. "Do you have anything like Imodium?" I was told that the stuff they has would not just 'suppress my symptoms'

4. I was given a tub of pills with the following label:

TRAVELLER'S DIARRHOEA

RELIEVES SYMPTOMS OF DIARRHOEA & VOMITING DUE TO

CONSUMPTION OF UNWASHED FRUITS, VEGETABLES, BAD MEAT

OR FISH. DOSAGE. TAKE 2 TABLETS EVERY HOUR UNTIL BETTER

ARSENICUM 30/PODOPHYLUM 30/PYROGEN 6/CARBO VEG 30/NUX

VOMICA 30

EXP 12/12 KEEP OUT OF CHILDRENS REACH

NELSON'S HOMEOPATHIC PHARMACY

73 DUKE STREET, LONDON W1K 5BY 020 7629 3118 P

5. On the 28th of March 2008, I submitted an enquiry to the MHRA suggesting that this might be an illegal product as it had no marketing authorisation. On the 14th of April 2008 I was told that the case had been passed onto the MHRA's Enforcement and Intelligence Group. I finally got a reply some 17 months later to tell me that "The outcome of the investigation is that following advice from the Enforcement Unit, Nelson's have removed the product you mentioned from their display shelves."

6. To date, the product is still available for sale[2] on the Nelson's web site along with many other similar products with specific indications. You can also see other similar products that are intended to cure constipation, accident & injury, allergic reactions, bites & stings, hangover & indigestion, heat exhaustion, jet lag, and sun exposure. All are similarly ineffective.

7. Whilst these conditions may be relatively minor, other homeopathic pharmacies sell remedies for much more serious conditions.  Neal's Yard Remedies were selling sugar pills to customers and telling them that these could prevent malaria. The BBC undertook an investigation and interviewed their 'Medicines' Director, who stormed out of the meeting after being asked if this was ethical and legal.[3] After the BBC forwarded on their evidence, the MHRA investigated and merely slapped their wrists. This is despite the fact that this product has the potential to kill if taken in the place of a real malaria prophylactic.

8. It would appear that the MHRA take a very light touch and piecemeal approach to investigating this widespread abuse of the regulatory system.

Examples of other products are: Migraine Headaches (Helps with migraine symptoms.) http://www.nelsonshomeopathy.com/shop-online/Migraine-Headaches_prod1628.aspx

Morning Sickness Relief (To help relieve symptoms of morning sickness....)http://www.nelsonshomeopathy.com/shop-online/Morning-Sickness-Relief_prod1629.aspx

PMT (To help relieve symptoms of premenstrual tension.) http://www.nelsonshomeopathy.com/shop-online/P.M.T._prod1634.aspx

Sore Throat (To help relieve symptoms of sore throat) http://www.nelsonshomeopathy.com/shop-online/Sore-Throat_prod1639.aspx

The Nelsons Quit Smoking Kit http://www.nelsonshomeopathy.com/shop-online/The-Nelsons-Quit-Smoking-Kit_prod1664.aspx

9. Homeopathic pharmacies are full of products with direct and implied claims. In order to understand the extent of the problem it is necessary to understand mainstream homeopathic beliefs. The pharmacies are stocked with products that are often derived directly from diseased tissues, vaccines and infectious samples. These are designed to treat or prevent the diseases they are derived from. Visiting a homeopathic pharmacy web site will show many products with implied indications. [4] These are often in the form of what homeopaths call nosodes where some diseases tissue or some other 'infectious' agent is taken and serially diluted and shaken and probably banged against a leather bible many times to create the homeopathic pill. The remedy lists of Ainsworths show products for each Influenza strain going back 20 years. You will find homeopathic replacements for Measles vaccine, Parotitis vaccine (mumps) and Rubella. You find homeopathic sugar pills for all forms of Hepatitis, strains of TB, and Typhoid, as well as the usual comedy remedies such as shipwreck, trout and Ayres rock.

10. These products are making implicit claims to be alternatives to real vaccines. They would appear to be all unlicensed remedies.

11. In my opinion, it is a mistake to regulate homeopath products as if they were medicines, with or without different levels of evidence for efficacy. Homeopathy is not a medicine. It is a pseudo-medicine with believers who belong to more of a cult than a profession. It is a disgrace that these products can appear on the same shelf-space as real medicinal products with misleading claims ratified by the MHRA. Claims made or implied by homeopaths should be subject to Trading Standards laws rather than given the false legitimacy of MHRA approval.

12. It is wrong to allow this to continue on the basis of consumer 'choice'. Choice can only be meaningfully be exercised when it is informed. In buying medicines, we so often have to defer to experts - we cannot always check all claims all the time - we are all 'vulnerable' consumers in this context. The MHRA has an overriding duty to ensure it is not helping to mislead consumers when they are making their choices about medicines.

The evidence base on homeopathic products and services.

13. It is absurd to continue to question the evidence base of homeopathy. The question was settled in the 1830's. It is only homeopaths who continue to believe that there is something special going on in their pills. If homeopathy had not been invented around 1800 but turned up today, would be seriously be considering funding this with millions of pounds in the NHS? The concept would appear absurd and the work of fevered imaginations. It is mere familiarity of this delusion that stops us taking this approach now.

14. Homeopaths continue to press that there is an evidence base. This is usually based on the following fallacies:

a. A "wealth" of positive evidence. Of course, it is possible to make a case for any absurd proposition if you only present positive evidence. Clinical research can very often create false positive results by chance, poor study design or fraud. In order, to evaluate a proposition, all evidence must be taken into account - positive, negative and neutral. Homeopathy does not stand up to such scrutiny.

b. Selective quoting of review conclusions. Many systematic reviews have show the weakness of the evidence base. However, within such reviews there have been some hints of positive results. It is now thought that such hints are the result of poor input studies - garbage in, garbage out. As the years have gone by, the reviews have become more sophisticated and clearly shown that studies with better methodologies and larger numbers of participants fail to show positive effects for homeopathy. Shang (2005) is the most definitive here. [5]

Homeopaths have attempted to discredit Shang. They have failed. They assert that Shang would have come to different conclusions if different studies or different criteria were included. This is self evident and irrelevant. Shang could be discredited if homeopaths could show a quality reanalysis that came to a conclusion opposite to that given - they have not been able to do so.

c. Claims of success in distant lands and distant times. Very often claims exist that homeopathy cured the 1918 flu epidemic or is used successfully in Cuba. These are anecdotal stories with no hard evidence to back them up.

d. Claims of physical experiments that show genuine effects of the 'memory of water'. None of these experiments have been taken seriously and have not been authoritatively replicated.

e. Claims that quantum mechanics hold the answer. A few academics have fiddled with the language of quantum theory and tortured it into the world of magic medicine. It is muddled and unconvincing and the authors involved appear to have a very poor grasp of the quantum theory.

Declaration of Interests

I am a writer about quackery on the web site quackometer.net. It is a hobby. I have no financial interest matters relating to medicine or pseudomedicine.

 

November 2009



[1] Ultramolecular homeopathy has no observable clinical effects. A randomized, double-blind, placebo-controlled proving trial of Belladonna 30C. Brien SLewith GBryant T. Br J Clin Pharmacol. 2003 Nov;56(5):562-8.

[2] http://www.nelsonshomeopathy.com/shop-online/The-Nelsons-Travellers-Companion_prod1731.aspx

[3] http://news.bbc.co.uk/1/hi/england/devon/7385718.stm

[4] http://www.ainsworths.com/site/combination.aspx

[5] Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet. 2005 Aug 27-Sep 2;366(9487):726-32.