Nelson’s homeopathic arnica: no evidence of efficacy but wins licence
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Strange but true.. the UK’s medicines regulators have bent over backwards to help CAM remedies become licensed - so much so, however, that even CAM supporters are wondering if they’ve gone too far.
This month the MHRA has given Nelson’s the UK’s first ever licence for a homeopathic medicine.
It is the first licence to be awarded under a controversial new MHRA scheme which allows homeopathic remedies to side-step proof of efficacy required for other medicines.
Critics say the approval by the Medicines and Healthcare Products Regulatory Agency gives consumers the impression that the MHRA is saying that homeopathy is scientifically proven. And Ironically, arnica is one of the most contentious homeopathic remedies, as several clinical trials and a systemic review by Prof Edzard Ernst’s team at the University of Exeter have found no evidence that homeopathic arnica works any better than placebo.
The MHRA has granted Nelson’s Arnicare 30c pillules a licence for the relief of sprains or bruising, allowing the product label to state: “A homeopathic medicinal product used within the homeopathic tradition for symptomatic relief of sprains, muscular aches and bruising or swelling after contusions.” Robert Wilson, chair of Nelsons, said: “The fact that therapeutic indications may now be included on the packaging of licensed homeopathic medicines not only opens the practice of homeopathy up to new users but also gives it added credibility as a safe and natural complement to conventional medicine.”
And it is that added credibility that has roused the ire of scientists. Prof Ernst said that homeopathic arnica has been tested more often than any other homeopathic remedy and does not work: “There is no biological plausibility, so this is a cynical mockery of evidence-based medicine”, he said.
The licence has been awarded under the MHRA’s new Homeopathic National Rules Scheme, introduced in September 2006 to facilitate licencing of remedies. However, critics say the Scheme has made licencing too easy, as it explicity states that homeopathic remedies can be awarded licences without having to demonstrate that they work.
The MHRA says: “The purpose of the Scheme is to enable homoeopathic medicinal products to be registered with indications for the relief or treatment of minor symptoms and conditions (those that can ordinarily be relieved or treated without the supervision or intervention of a doctor)”. As long as the conditions or symptoms being treated are minor, says the MHRA, “the rules do not require rigorous clinical data”.
Amazingly, the MHRA accepts homeopathic provings in considering efficacy.
The rules for submission of a product for licencing say manufacturers must come up with evidence of quality and safety and “one or more” of the following:
• Study reports in relation to the product which is the subject of the application,
• Published scientific literature;
• Homoeopathic provings.
In an podcast interview with the British Medical Journal, Prof Ernst commented: “I’m sure the product by Nelson’s is of good quality and is entirely safe; it actually doesn’t contain any arnica because it is too highly dilute to contain any arnica, so it’s got to be safe. And proof of efficacy in the traditional way is not required, therefore it can obtain a licence. All this simply shows that the regulation for homeopathic products is barmy.”
* The Homeopathic National Rules Scheme, Brief Guidance for Manufacturers and Suppliers, September 2006 MHRA: www.mhra.gov.uk
* Evidence for, evidence against, BMJ Podcast, 15 May 2009, by Birte Twisselmann: www.bmj.com
Why cancer screening isn’t all it’s cracked up to be - by Prof Baum
Well worth a read is Prof Michael Baum’s new essay “Why I am still a screening sceptic”, now up on the Spiked website.
Highlights:
‘The largest threat posed by American medicine is that more and more of us are being drawn into the system not because of an epidemic of disease, but because of an epidemic of diagnoses. The real problem with the epidemic of diagnoses is that it leads to an epidemic of treatments. Not all treatments have important benefits, but almost all can have harms.’ (Actually a quote from other writers: “What’s Making Us Sick Is an Epidemic of Diagnoses”, H GIlbert Welch, Lisa Schwartz and Steven Woloshin, New York Times, January 2, 2007).
“More recently, last weekend The Sunday Times reported that more and more women are angry about having had needless breast cancer operations, after research showed that ‘10 patients will be treated unnecessarily for every life saved’. The paper reported my view that, instead of breast-screening the whole female population over the age of 50 every three years, women should be tested ‘according to their level of risk’ - an argument I will expand on in this essay (3).”
“Although it seems counterintuitive, a growing body of informed opinion is moving in the direction of exposing early detection of cancer as just that: possibly a ‘bad thing’.”
“As a result, the overall mastectomy rate rises after any country implements screening in contrast to the message in the NHSBSP leaflet - ‘Breast Cancer: The Facts’ (10) - which implies that screening saves breasts. It doesn’t.”
“I want to argue that some of these earliest stages of ‘cancer’, if left unperturbed, would not progress to a disease with lethal potential.”
“…you would need to screen 1,400 men for 10 years to save one prostate cancer death at the expense of over-diagnosing 48 cases of cancer that would be treated with radical surgery that frequently leads to impotence and incontinence and on rare occasions death from the complications of surgery.”
Save the ‘people’s medicine’ : sign herbal medicine petition
An anonymous herbal medicine practitioner has launched a petition in support of herbal medicine which is up for signing at the online website GoPetition.
The petition highlights UK Government moves to statutorily regulate medical herbalists and changes to the regulation of herbal medicines, both of which, says the petition, will “reduce access, increase costs, decrease patient choice, encourage a black market and send experienced herbalists underground, crucify our indigenous tradition and diversity of available healthcare”.
Phew! I can’t help but agree. Beneficiaries of the changes are unlikely to be the general public, but the pharmaceutical industry.
* Read the full premble and then electronically sign the petition here.
New voluntary register opens today
Press release from the British Complementary Medicine Association:
“The British Government has long wanted complementary practitioners to organise themselves in a way that could enable complementary medicine to be more readily accepted as a further aid to health care within the structure of the Health Service as well as the private medicine sector.
“To date two Voluntary Self Regulation councils have evolved, but the British Complementary Medicine Association has always had reservations about their choice of philosophy. As a result, the BCMA initiated the development of a new Council, the British Complementary Therapies Council (BCTC) that will open its register on 1st May to practitioners who wish to be recognised as meeting the requirements of the House of Lords Report but to date, have not found a council that meets their requirements.
“So, how is the BCTC different? The answer is that first and foremost, all the standards and requirements a practitioner must meet are in straightforward, plain English that everybody will easily understand. This is essential when you want practitioners to make a voluntary decision to apply for registration. The second important thing is that all therapies regulated by the BCTC will have a representative for that therapy as part of the council. This, we believe, is the most appropriate way to protect the public in a way that does not risk undermining the quality of the therapy itself.”
Further information is available on the BCTC website) or the BCMA website. Alternatively you can speak to an admin representative on 0845 345 5977
