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Last Friday, the medicines regulator (the MHRA), signaled its desire to finally end the 40-year anachronism of homeopathic Product Licences of Right (PLRs):
Guidance on the transfer of certain Product Licences of Right (PLRs) to homeopathic marketing authorisations under the National Rules Scheme or to registration certificates under the Simplified Registration Scheme.
A mouthful of a title, but its aim is clear: to encourage homeopathy manufacturers to transfer their PLR products to either the Simplified Homeopathic Rules (HR) Scheme or the National Rules (NR) scheme.
For the past 42 years, these products have been given a free ride in terms of not having to comply with the same rules as other products classed as medicines. As the MHRA says:
Product Licences of Right (PLRs) were issued to all medicinal products on the market at the time that the Medicines Act 1968 was implemented (in 1971). PLRs were envisaged as a temporary arrangement until products were reviewed and, where appropriate, moved to an ongoing regulatory scheme where they would meet the relevant standards. Most categories of medicine, except homeopathic medicines, which were exempted under Directive 75/319EEC, were subsequently reviewed by the early 1990’s and products were either granted a full Product Licence or the PLR was revoked.
Their announcement said:
Product Licences of Right (PLRs) holders are invited to transfer certain homeopathic products with PLRs to either homeopathic marketing authorisations under the National Rules Scheme or homeopathic registration certificates under the Simplified Registration Scheme.
Unfortunately, the MHRA has not given a deadline, and the MHRA say they will transfer for free (for the time being at least), so that the manufacturers will not even have the burden of the usual fees they would have to pay for HR or NR applications.
According to the MHRA's data (obtained through a Freedom of Information Request), there are 406 PLR products, most of which are homeopathic. These include 32 New Era products (that Seven Seas/Merck abandoned earlier this year), 319 Weleda, 54 Nelsons and one product from the (possibly now defunct) Anglo German Homeopathic Centre, based in Hereford.
In many ways this is good move: any PLR products that transfer to the HR scheme will not be allowed indications (ie to say what medical conditions they can be used for) and will all have to have the following text on the product:
Homeopathic medicinal product without approved therapeutic indications
Products that are transferred to the NR scheme will be allowed indications if the manufacturer can provide 'evidence' for therapeutic use for that indication. Of course, no actual evidence at all is required: they just have to show that it’s been used for whatever the condition by homeopaths in the past or provide a 'proving' for it.
However, this means they are brought under control to some extent and are more tightly controlled in terms of advertising. At least NR products have to carry the wording:
A homeopathic medicinal product used within the homeopathic tradition for the relief of or treatment of…
…followed by the conditions it can ‘treat’ as permitted by the product’s Public Assessment Report.
Take Nelsons Teetha Teething Gel that was authorised last year (not to be confused with Nelsons PLR Teetha teething granules, pictured above). This has the official-sounding NR authorisation number NR 01175/0184 and has the 'active ingredients' Chamomilla recutica, Aconitum napellus and Atropa belladonna. Although these may sound dangerous — particularly the belladonna — these are all at 12C dilution, so, as long as they are properly and carefully diluted, under an adequate quality regime, there is just a 60% probability of it containing just one molecule of the original material if one mole of the original substance was used. This product's Public Assessment Report (PAR) give details of the product and its assessment.
Under the heading Evidence supporting the proposed indication, it states:
No new clinical data were submitted and none are required for an application of this type. In support of this application details of homeopathic provings and published scientific literature have been provided. These are adequate evidence to support the indications for which a national rules authorisation is sought.
And what did this 'evidence' substantiate in terms of indications?
A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of teething pain and the symptoms associated with teething which are sore and tender gums, flushed cheeks and dribbling.
Anyway, at least this limits what therapeutic claims can be made, even if they are not based on any measure of credible evidence. The same will apply to any PLR products transferred to the NR scheme.
There are, of course, manufacturing standards to be met even for the HR scheme. Providing the dossier required by the MHRA for an application should be relatively trivial for any competent manufacturer, but some may well struggle. The contents of the dossier required for submission is given here: Homeopathic applications (Simplified Registration Scheme and the National Rules Scheme).
There are ongoing periodic fees, but the periodic fee for a NR product is the same as that for a PLR; this measly £80 is only a tiny fraction of the fee required by the MHRA for 'Big Pharma' medicines and the periodic fee for an HR scheme product is zero.
Allowing any homeopathic product to make therapeutic claims is hardly ideal and unwitting members of the public could still be misled into thinking these homeopathic products are real medicines, but at least this a step in the right direction for consumer protection.
At present, the MHRA have not said when they would like all PLRs to be either ended or withdrawn, but we urge them to scrap PLRs completely as soon as possible. There is no reason why this anachronism should be allowed to continue any longer and we hope that PLR products will finally be consigned to history.
A final word about 'provings': these are used to 'justify' the indications that are permitted for National Rules Scheme products.
However, the word is derived from the German Prüfung, meaning 'a test', and does not mean they provide any kind of proof that the product is effective for these indications. In the words of the Society of Homeopaths:
A pre-defined number of repeated doses of the homeopathic remedy are given to healthy volunteers until symptoms are experienced. These are collated by observers and distinctive symptoms common to multiple participants (which are most likely to be related to the medicine) are identified. According to the central homeopathic principle that ‘like cures like’, the remedy may have the potential to treat these specific characteristic symptoms.
Most readers will be able to spot rather obvious flaws in this thinking. They also like to call them 'homeopathic pathogenetic trials', but they are not clinical trials in the conventional sense or indeed in any meaningful sense.
We have more to say about provings and their status…but you'll need to wait for our next newsletter to find out!
10 November 2013
There are rules surrounding the advertising of medicines. There have to be to protect the public from misleading claims. It's illegal in the UK, for example, to advertise prescription medicines to the public. That protects the public being swayed by advertising gloss, spin and downright deception and probably saves many a GP from being bombarded by requests for medicines they do not need.
But there are also rules and regulations surrounding homeopathic medicines. These are enshrined in various EU Directives and transposed into UK laws and regulations. (Unfortunately, those same Directives call them 'medicines' — this is highly misleading in itself, of course, but, when discussing the regulations formally, it is easier to stick to the terms it uses.)
All medicines in the UK are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) and they publish their guidance on advertising in what they call their Blue Guide: Advertising and Promotion of Medicines in the UK. A special Annex gives guidance on the advertising of homeopathic medicines that also gives useful information on the underlying EU Declarations and legislation.
But first, some background on the categories of homeopathic products that the MHRA 'regulate':
There are no homeopathic medicines that have Market Authorisation because evidence of efficacy is required — a dizzy height homeopathy has never been able to reach, of course. Conventional medicines have MAs.
There are under 500 homeopathic products that have Product Licences of Right, but the only requirement they had to meet to gain this licence was that they were on sale in 1971 when the Medicines Act 1968 came into force: no proof of safety; no proof of efficacy. In fact, all medicines, homeopathic or not, were automatically given PLRs by the MHRA’s predecessor, the Medicines Control Agency. But, by the early 1990s, most conventional medicines had been reviewed and either given a full product licence (MA) if they met the criteria (including evidence for efficacy) or they were withdrawn from the market.
The MHRA allowed homeopathic medicines, Bach flower 'remedies' and Anthroposophic 'medicines' to remain with PLRs and continue to make claims about what medical conditions they can be used for. The MHRA was minded to remove this category a few years ago, but has unfortunately backtracked on that. One possible reason for this might have been pressure from the homeopathy industry, wanting to continue to freely make unevidenced claims about their products. We hope to say more about this and PLRs in a future newsletter.
The next category is the National Rules Scheme. Homeopathic medicines authorised in this category are permitted to say they can be used for the 'relief or treatment of minor symptoms or minor conditions in humans' — those that 'can ordinarily and with reasonable safety be relieved or treated without the supervision or intervention of a doctor'. In the jargon, they are allowed to claim 'therapeutic indications', but only those that have been permitted by the MHRA for each individual product as stated in their Public Assessment Report (eg this for Nelson's Teetha teething gel). For various reasons, there are just eight homeopathic medicines in this category, with most of them appearing in just this last year, despite the scheme being launched in 2006. The mandatory wording on the product is:
A homeopathic medicinal product used within the homeopathic tradition for the relief of or treatment of…
…followed by the permitted indications. Note that these indications come from historic homeopathic literature of what it's been used to treat or from 'provings'. These 'provings' (from the German Prüfung, meaning a test, not a proof), although called 'homeopathic pathogenetic trials' by some homeopaths, are not clinical trials in the conventional sense — but this yet another topic for a future newsletter.
The final category is Homeopathic Registration: the MHRA has issued fewer than 300 registrations to ten different homeopathy manufacturers. No evidence of efficacy is required, of course, but they are not allowed to make any therapeutic claims either — how could a regulated product be allowed to make claims when it's not been tested for those claims? Instead, they must have the following words on them:
A homeopathic medicinal product without approved therapeutic indications.
Whether or not an unsuspecting member of the public understands what this jargon means is a moot point.
A full list of all NR and HR homeopathic medicines is available from the MHRA.
Any homeopathic medicine not falling into one of the above categories is an unlicensed medicine. As such, there are strict rules on advertising them: it is illegal to advertise an unlicensed medicine to the public.
The double-standards and the extremely low hurdle to be achieved by homeopathic products should be obvious.
In summary, for homeopathic products:
However, we have found may sellers of homeopathic medicines advertising outside these restrictions. We've highlighted a few in the past, mainly Holland and Barrett, but we have been complaining about others too.
Because these have taken time to be resolved and have been resolved at different times, we've said little before now. However, now is the time to publicise our successes.
Several UK sellers were advertising Boiron's Oscillococcinum. This is an unlicensed medicine in the UK. The sellers included:
…and the following amazon.co.uk and/or ebay.co.uk sellers:
While many of these have been removed after being contacted by the MHRA, there are a few others, including several registered pharmacies, that have yet to make the necessary changes. Further action is being taken and we'll let you know the outcome in due course. Some of these complaints about registered pharmacies were passed to the statutory pharmacy regulator, the General Pharmaceutical Council. However, there are further issues they have yet to deal with.
However, the MHRA were unable to take action against one seller, Doc Simon, because, although they have a UK domain name and look to all intents and purposes like a UK company, they appear to be based in the Czech Republic. It is not illegal to import unlicensed medicines into the UK for your own personal use, so there was nothing the MHRA could do about this website, even though they are advertising and selling to the UK.
Unfortunately, the MHRA have not published the outcomes of these complaints, so it's been left to us to make people aware of them.
We will continue to monitor all those websites, of course.
Some of the major homeopathy manufacturers have already had to make changes to their websites after we submitted complaints to the MHRA, including Nelsons. We currently have several other complaints running — these are proving more time-consuming to resolve, but progress is being made and we will let you know when these are concluded.
We've submitted complaints to the MHRA about many other advertisers of homeopathic medicines, including one ebay seller, Wingate, where we questioned several aspects of their advertising, including incorrect labelling of re-branded products. Again, the MHRA chose not to publish the outcome of these complaints on their website.
However, the outcomes of our latest batch of complaints to the MHRA were recently published.
As we've seen, the MHRA do not always announce the results of their investigations, so we welcome this publication that stands as a marker for other sellers that they have to check that their advertising is compliant.
The common issues we found were:
The sellers we complained about included:
We have since checked these websites and have notified the MHRA that we believe some of them are still in breach of the advertising regulations. Others are no longer advertising any homeopathic products.
We believe this is good progress and we hope the MHRA will publish the outcomes of future complaints.
However, the MHRA is still dealing with some seven others, including some Registered Pharmacies and homeopathy manufacturer. Once these have been concluded, we'll publicise the results.
Out of this last batch, there are a couple of particular interest.
This website was one of the main sellers of a homeopathic product called Schüssler (Schuessler) Tissue Salts. These have been touted as the replacement to New Era — owned by Seven Seas, who in turn are owned by pharmaceutical giant Merck — tissue salts (which had a PLR) that were withdrawn earlier this year. The New Era brand seems to have been sold to Olimed Limited, a subsidiary of Italian company Named SpA, so we can probably expect to see these products re-appear in the future.
However, Schüssler products are not registered or authorised and are therefore unlicensed medicines. Many other retailers have been selling them, but this appears to be their main website in the UK. This shop now displays the message:
This website was selling products manufactured by Heel GmbH, but the shop facility closed after our complaint. This range includes all sorts of homeopathic products, some of which are injectable. As these are neither registered nor authorised by the MHRA, they are unlicensed medicines.
After our initial complaint, the owner, Sarah Bell, sent out an email to her mailing list (all typos as in the original):
Recently I have been hassled by the never ending growing body of rules and regulations which are set out here in the UK regarding homeopathic remedies and the Heel remedies. It is a vicious monster in my opinion and does a great deal of harm.
Fortunately we have set up a system which enables me to contiue to supply and help you obtain the Heel remedies. So, do not worry. I have your back.
Although I now understand why many practitioners in the UK baulk at the prospect as it is difficult and requries stamina to say the least. Thick skin?! I think so!
However this is my problem not yours.
I will continue to provide access to you of the complete Heel range of remedies. I may in future be updating the blog in the private shop site and not the public site in order to comply with their regulations.
I get very annoyed as due to their regulations they make it extremely difficult and expensive for most people to obtain what I think is an outstanding range of homeopthic remedies which go such a long way to helping people maintain phenomenal health - so how dare they do everything they can to make them extremely difficult to buy and obtain?
C'est la vie - we are in a society run by so many rules that they counteract all the good they are supposed to do.
The quote I read was:-
Every adversity, every failure, every heartache carries with it the seed of an equal or greater benefit. - Napolen Hill
Do you have any inspiring quotes that help you get through tough situations? If you do, just reply to this email! I'd love to hear what helps you when times are tough. I think of it as fighting an ongoing battle - you and I together.
We will live on another day and keep on fighting this battle!
And finally my "call to arms" - please pass on the private shop link to friends and family and colleagues. Help me continue to keep helping those who know drugs are not the answer.
"Never, ever, ever, ever, ever, ever, ever, give in. Never give in. Never give in. Never give in." - Winston Churchill (but you already knew that!)
She even Tweeted about her new 'private' shop:
Struggling with Bronchitis & chest infections? Contact me - I will send you a private shop link so you can buy Heel Homeopathic Remedies
So, instead of simply obeying the statutory medicines regulator, Bell opened up a new 'private' shop where she could carry on selling the unlicensed homeopathic medicines to her customers. We passed her email on to the MHRA; the shop facility no longer exists.
Although she is the main seller in the UK, Heel GmbH homeopathic products are still available from some other suppliers, so we’ve pointed these out to the MHRA.
As we have explained above, the regulation surrounding the advertising of homeopathic 'medicines' are fairly straightforward and easy to understand. They are not arbitrary and complying with them is not optional: they are legal requirements. That so many homeopathy traders and advertisers have been found to be non-compliant suggests a wide-spread disregard for the medicines regulations, which are there to protect the public from misleading, false and unsubstantiated claims.
All homeopathy manufacturers, advertisers and sellers have an ethical and legal obligation to abide by them — whether they like them or not.
01 November 2013
Of all the complementary and alternative therapies, herbalism remains much the odd one out — there is at least some prior probability that many plants or plant extracts will have a pharmacological effect on humans. Indeed, there is some evidence that some herbal products have beneficial effects. There is, of course, also good evidence that many herbal products are dangerous and can cause severe side effects, even death. And that's ignoring the adulterated and contaminated products.
The appeal to nature fallacy abounds amongst many promoters of herbal products, but natural implies neither efficacy nor safety — each claim must be looked at separately and the evidence considered.
When we came across a leaflet advertising the Western Herbal Medicine service of the Royal London Hospital for Integrated Medicine (part of UCL Hospital Foundation Trust), we wondered if they could substantiate the claims they were making. So we submitted a complaint to the Advertising Standards Authority (ASA), who regulate advertising.
That was three years ago, and, after a long and thorough investigation, the ASA's adjudication on our complaint is published today, upholding 10 out of 11 points.
The leaflet on Western Herbal Medicine stated:
Conditions particularly suitable for treatment by herbal medicine are:
- Digestive disorders
- Urinary disorders
- Women’s health
- Joint problems
- Skin conditions
- Hormonal conditions
- Fatigue syndromes
- Recurrent infections
Before looking at the evidence provided, it's worth pointing out the RLHIM's definition:
Western Herbal Medicine usually consists of a bottle of alcohol-based tinctures, with up to five different herbs mixed together.
This brings to mind Prof David Colquhoun's quip:
Herbal medicine: giving patients an unknown dose of an ill-defined drug, of unknown effectiveness and unknown safety.
We will have more to say about the quality of some herbal medicines used at a later date.
The ASA challenged each of eleven conditions and asked the RLHIM to provide evidence for all of them.
We can only assume, knowing what was at stake if they were to lose the adjudication, that RLHIM would have ensured that the best evidence available was provided. Indeed, RLHIM stated that:
…the body of evidence supported the claims that herbal medicine could be used to treat the listed conditions.
The ASA and their expert disagreed.
RLHIM provided a total of 69 papers in support of their claims.
For many of the claims, the ASA concluded that while some of the evidence provided supported some specific claims falling within rather broad categories, they concluded that the RLHIM had not provided enough robust evidence, covering a range of conditions that could be inferred from the broad categories listed. For example, for the first category of 'digestive disorders', the ASA rejected the evidence provided for inflammatory bowel disease but were happy with the evidence provided for irritable bowel syndrome and functional dyspepsia. However, the ASA didn't consider that those two latter conditions adequately covered the claim being made for 'digestive disorders'. Accordingly, the ASA concluded that the claim was unsubstantiated and misleading.
Many of the other claims were similarly unsubstantiated because of the broad nature of the claim: urinary disorders, allergies, joint problems, skin conditions and recurrent infections.
No doubt, if they re-publish the leaflet, they will be able to limit their claims to the specific conditions they have good evidence for, but, instead of the rather wide-ranging impression given on the original leaflet, a rewritten one might look a bit sparse.
It's instructive to note the assessment of many of the papers that the RLHIM provided. Remember that the ASA require an advertiser to hold — at the time they make it — robust scientific evidence for any claim. It's made very clear that unblinded, uncontrolled, non-randomised trials are likely to be unacceptable. Yet the ASA comments reveal what they thought of much of the RLHIM's evidence:
only a small number of patients and were of a short duration
none included power calculations to demonstrate conclusively whether the treatments were efficacious
all had flaws in their methodology
the test material was not precisely defined
The other RCT also lacked from precise product definition.
The systematic review was also lacking in detail and robustness.
We did not consider the general treatment review to be useful in supporting the claims in the ad because, unlike an RCT or a systematic review, it did not analyse any data
a general treatment review looking at complementary and alternative remedies
evidence for Chinese herbal medicine
some studies of poor methodological quality
overall the evidence was not sufficiently robust
half of the studies submitted lacked sufficient details on design, methodology and/or statistical analysis to be considered suitably robust.
Other weaknesses…included small sample sizes, short durations and populations that might not have been representative of the typical patient population
The evidence for the remaining herbal medicines was weak.
most of the studies provided were of a poor methodological quality, with limitations including flaws in the statistical analysis, small sample sizes and short treatment durations.
the authors of the ginseng study concluded that that study alone was not sufficient in demonstrating the overall efficacy of Siberian ginseng in reducing fatigue.
both studies contained a number of weaknesses that limited their usefulness as evidence for the claim: these weaknesses included: small study sizes; short study durations; lack of a demonstration of statistical significance; lack of power calculations and a lack of detail on methodology and randomisation.
the authors were unable to show data to demonstrate efficacy in other forms of acute respiratory infection
It is damning that this is the best evidence that an NHS hospital can come up with for the treatments it provides at the taxpayer's expense. But, even though there is at least a level of plausibility of herbal products, the RLHIM wasn't able to do much better than it was for acupuncture.
The RLHIM provided evidence that kava kava was effective for anxiety — even though this was for the claim about stress, not anxiety. However, that would be fine except that the medicines regulator banned the sale, supply and importation of any kava kava based product in 2002 because of widespread concerns about its hepatoxicity. So, even if it is effective, the RLHIM would not have been able to legally prescribe it. The ASA, rightly, rejected this as evidence for the claim.
But they were able provide evidence that satisfied the ASA for their claim about migraines, so the ASA did not uphold this point. However, the reports provided for migraine prophylaxis (ie prevention of migraines), not relief of migraines themselves. We argued that a reader would infer from the claim for migraines, that they could provide a herbal medicine that would alleviate a migraine headache. The ASA were not persuaded by our argument.
In an attempt to substantiate their claim about 'recurrent infections', the RLHIM provided evidence for acute bronchitis, acute rhinosinusitis, acute respiratory infection, the common cold and upper respiratory tract infections. The ASA accepted some of this (including the use of Echinacea for the common cold) and rejected others. However, the ASA noted that the claim was for the treatment of 'recurrent infections' not just these respiratory conditions. The ASA therefore ruled that the claim was misleading.
It should also be noted that, as an NHS hospital, referrals to the RLHIM for treatment can only come from your GP or an NHS consultant. It does not seem likely that a GP would refer you to the RLHIM just because you had a cold — recurrent or otherwise. After all, Echinacea products are easily available from any supermarket.
The ASA upheld the complaint on 10 of the 11 points, declaring that the RLHIM ad breached the CAP Code on no less that 30 counts.
The ASA told the RLHIM:
The claims investigated and found to be in breach of the Code must not be used again. We advised UCLH to take care in future advertising not to over claim when making general claims for services using herbal products.
But, having looked at the evidence supplied, they also said:
Conditions for which some herbal medicines were found to have some effect included: functional dyspepsia, IBS, premenstrual syndrome, back pain and OA, depression, some forms of acute infections including acute rhinosinusitis, the common cold, uncomplicated upper respiratory tract infections, influenza types A and B and migraine.
So, this should now form part of the guidance for advertisers and we expect CAP to update their guidance. All other advertisers of herbal products should now take note and ensure their websites, leaflets, etc comply.
We don't know exactly what papers the RLHIM submitted, although an FOIA request — or a bit of detective work on Pubmed — would disclose them. But some of the herbal extracts in those papers are identified in the ASA adjudication.
However, what the RLHIM provided was a list of papers that tried to substantiate the claims made in the leaflet: what is not entirely clear is whether the herbal products in those papers are actually the ones used by the RLHIM in their treatments. For all we know, they may provide completely different herbal treatments — indeed, that may be even quite likely given the difficulty they appear to have had in coming up with good evidence.
So, it is left as an exercise for the reader to marry up the products mentioned in their evidence with a list of herbal products stocked at the RLHIM, obtained through an FOIA request earlier this year — this spreadsheet contains all the data.
Now that we have had three adjudications and one informally resolved case covering four RLHIM leaflets, we can step back and look at how the RLHIM has fared:
Yes. 51 CAP Code breaches from just four leaflets.
The current phase of our complaints about claims made in leaflets published by the Royal London Hospital for Integrated Medicine (the Royal London Homeopathic Hospital as was) is nearing completion. We've already won complaints about their:
We did look at their leaflet advertising their homeopathy services, but it made no substantial claims about homeopathy.
This now leaves their website and their leaflet collection looking a little sparse — many website pages (such as their reflexology page) now only link to a login page so that the content is hidden from public view.
These successes have all been through complaints to the ASA. But we have also been using the medicines regulator, the MHRA, and the HCPC (the regulator of podiatrists and chiropodists and other healthcare professions) to ensure that the unlicensed Marigold Therapy products are only used and advertised by those legally entitled to do so. Since most podiatrists and chiropodists are not permitted to supply unlicensed medicines, we reported 39 websites advertising Marigold Therapy to the HCPC and we will report more on this part of the campaign in a future newsletter.
But of course, this is not just about the words they use in their leaflets or on their website.
At what must surely be the most prestigious and highest-profile organisation promoting and using all sorts of alternative therapies, it should have been straightforward for them to defend the claims they made. But as we've already seen, they were unable to provide the quality of evidence required by the advertiding regulator.
What is more worrying is the potential lack of good evidence for the treatments they use on their patients.
This cannot be good for the public who are referred to the RLHIM: if they don't have the evidence for the treatments they provide at the tax-payer's expense, then why are they providing these treatments at all?
And, as one of the hospitals within University College London Hospitals NHS Foundation Trust, their Board of Directors and Governing Body must now ask important and long-overdue questions about the evidence base for all treatments provided at the RLHIM.
They may have simply tolerated the historical anachronism that is the RLHIM up till now, but, after this latest round of embarrassment for UCLH, it is surely about time these fundamental and serious questions were asked and decisive action taken.
23 October 2013
Today sees the publication of two long-awaited adjudications by the Advertising Standards Authority (ASA).
One is the second of the ASA's 'master' homeopathy complaints, intended to set the precedent for future claims about homeopathy.
But this is no ordinary complaint about a homeopath making a few silly claims: it is an upheld adjudication against the Society of Homeopaths (SoH), the UK's most prominent homeopath membership organisation, boasting over 1,400 members.
The other is the revised adjudication of H:MC21's advert in New Statesman in 2010 after their appeal of the first ruling.
Although these rulings are not what homeopaths might have hoped for, they set the precedent for claims the ASA will and will not accept in adverts for homeopathy and the standard by which all others will now be judged.
Homeopaths now have the opportunity to finally fall into line and abide by the same rules as everyone else. The Society of Homeopaths have taken the lead by removing their What can homeopathy help? web page (cached).
But first, a look at these two crucial adjudications.
A long time ago, we suggested that our supporters submit complaints to the ASA about claims made on homeopathy websites. To cut a long story short, the ASA sent letters to these homeopaths (letter 1, letter 2 and letter 3) and then produced detailed guidance on advertising homeopathy services. After considering the matter, they also decided to investigate two 'master' complaints to examine all the evidence and to set a precedent for others to follow.
The first of these was Steve Scrutton Homeopathy and the ASA ruled that his website breached their CAP Code on four counts and stated:
The web pages must not appear again in their current form. We told Steve Scrutton to ensure he held robust evidence when making claims in future, and to ensure that he did not offer, in a marketing communication, specific advice on, or treatment for, conditions for which medical supervision should be sought. We advised him to contact CAP Copy Advice for advice on amending his marketing material.
We have been waiting for the ASA's final adjudication and it is published today.
This complaint was not submitted by us, so we had no idea which website was was being investigated; we now know it was the website and a Tweet of the Society of Homeopaths and the ASA identify themselves as challenger of the claims.
It used to make all sorts of claims about homeopathy, the 'growing body' of evidence for its efficacy and listed several medical conditions:
To date, conditions for which the majority of clinical trial findings have been positive include:
- Allergies and upper respiratory tract infections
- Ankle sprain
- Childhood diarrhoea; chronic fatigue
- Ear infections
- Hay fever
- Premenstrual syndrome
- Rheumatic diseases
The ASA asked for evidence to support these claims — and found it wanting; not measuring up to the high standards we expect and deserve from a body charged with protecting the public from misleading claims.
All in all, the ASA investigated 16 points — the 14 conditions specified and two points about discouraging medical treatment — and upheld all of them, ruling that the SoH breached the CAP Code on no less than 35 counts.
One interesting point is that they supplied some evidence not written in English. When asked to provide translations, the SoH didn't provide translations when requested.
For one claim, the SoH provided evidence for Boiron's Oscillococcinum product, claimed to help with flu symptoms. What is interesting is that Oscillococcinum is classed as an unlicensed homeopathic 'medicine' in the UK and as such, we understand, it can only be prescribed by medical doctors. We also understand it is illegal to advertise it.
The adjudication is thorough, describing how the SoH responded and what evidence they supplied to substantiate the claims made — it is well worth reading in full.
Overall, it is a resounding defeat for all homeopaths as well as the leading homeopaths' trade body; but it also is a resounding victory for consumer protection.
The other adjudication published today is the end of a long saga that started in 2010 when H:MC21 (Homeopathy: Medicine for the 21st Century) placed a full-page advert in the New Statesman. It attracted six complaints to the ASA. The ASA considered the complaint as 12 separate points and examined the evidence provided by the advertiser to substantiate their claims.
The ASA published their adjudication on 15 October 2011, upholding seven of the 12 points.
The points they didn't uphold included ones that denigrated Prof Edzard Ernst and the House of Commons Science and Technology Select Committee for their Evidence Check report on homeopathy. But that wasn't because they had not been denigrated by the advert, but simply because they did not fall within the categories of those protected from denigration under the ASA's CAP Code.
There were a couple of other more minor points that weren't upheld: we think they should have been upheld, but we felt that because it had already taken 12 months to investigate, it wasn't worth pursuing any further and wasting yet more of the ASA's time.
However, the main claims made by H:MC21 were about the the 'success' of homeopathy. They did provide lots of information about homeopathy and their beliefs about Evidence-Based Medicine and Randomised Controlled Trials, but didn't provide the necessary standard of evidence required by the ASA to substantiate the claims about homeopathy.
This should not have been unexpected: the ASA's standards for substantiation are very clear and well-known, so there can be no excuse for not understanding whether evidence is likely to meet the ASA's standards.
However, having not been provided with adequate evidence, the ASA upheld most of the points, ruling the ad breached the Code on no less than 20 counts.
As is their right, the advertiser requested that the case be referred to the Independent Reviewer, Sir Hayden Phillips. They supplied him with an 18-page document detailing the minutiæ of the ASA's handling of the case and what they believed was wrong with it as well as a copy of an article from the Radio Times and information from the British National Formulary about paracetamol.
The advertiser also supplied additional new 'evidence' for their claims, including the oft-cited and oft-misrepresented 'Swiss Health Technology Assessment' on homeopathy. The report, titled 'Homeopathy in Healthcare', was no such thing of course, and no matter how many times it's pointed out that the Swiss Government had to declare that it was not an HTA and that it was published 'without any consent of the Swiss government or administration', it is still represented by many homeopathists as being the definitive, independent, neutral, authoritative report on the 'effectiveness, appropriateness, safety and costs' of homeopathy. It most certainly is not.
Since this report was not published until long after the advert, it cannot be used to substantiate any claims: advertisers must hold the necessary substantiation at the time they publish the advert. Despite this, the ASA examined the report and in their revised adjudication, concluded:
After seeking expert advice, we considered that 'Homeopathy in Healthcare' did not move the case forward in favour of the efficacy of homeopathy in treating medical conditions, in light of conventional standards for efficacy. We noted that proponents of the homeopathic approach often objected to conventional medicine's focus on RCTs as the gold standard for assessing efficacy, and instead they favoured other forms of measurement in their assessment, such as patient self-analysis and outcome studies. Nevertheless, we continue to expect claims, that a particular medicine or approach could be used to treat medical conditions, be substantiated with a robust body of evidence, consisting of RCTs conducted on human subjects, where appropriate. We did not consider the alternatives put forward, such as patient self-analysis or outcome studies, alone to be suitably robust to support efficacy. because 'Homeopathy in Healthcare' did not include robust evidence, of the type we considered necessary, we considered it was insufficient to substantiate the efficacy claims made in the ad.
Sir Hayden considered all the evidence and new submissions. He asked the ASA to re-open the case and consider a few points. This they did and made some minor changes to their original adjudication, mostly consisting of small amendments to the wording surrounding H:MC21's submission and some clarification, spelling and grammatical corrections. But it essentially remained the same, with the same seven points being upheld.
Coincidentally, the revised adjudication is also published today.
Aware of the impending outcome, H:MC21 organised a protest outside the ASA's offices and a lobby of Parliament last week, trying to make this protest not just about their advert, but about restrictions on choice in medicine and seemingly wanting the ASA to consider anecdotes over more robust evidence.
They claim the ASA is denying the public the choice of homeopathy for their healthcare. That's completely wrong, of course: the ASA is there to prevent the public being misled by claims made in adverts. This is, unfortunately, much needed, whether it's an advert for washing powder, cheap flights, yoghurt or homeopathy and the same rules apply to everyone.
Regardless of what homeopathists might want the ASA's CAP Code to say, the same rules have been there for years: advertisers should have been perfectly aware of the conditions they needed to meet to ensure they were compliant and their adverts were 'legal, decent, honest and truthful'.
The issue of consumer 'choice' is just a common trope. The real issue is simply whether the advertiser can properly substantiate the claims made. And by ensuring advertisers can substantiate the claims they make, consumers are protected from misleading advertising that would otherwise deny them from making a fully informed choice. We want consumers to be allowed to make that informed choice.
H:MC21 used the following as a slogan in one of their protest leaflets:
Don't let advertisers restrict your choice in healthcare
That's something we wholeheartedly agree with, but we suspect that's not quite what H:MC21 meant. It is advertisers who restrict choice by giving misleading information or omitting vital information.
We have little doubt that these advertisers will have pulled out all the stops to provide the ASA with the best, most convincing evidence for homeopathy available from anywhere, whether RCTs, pilot studies, customer satisfaction surveys, magazine articles (peer reviewed or not), published in any journal, magazine, newspaper, leaflet or comic, and consulted the best homeopathy experts the world over.
They will have known what was at stake here: the claims that homeopaths will from now on be now able to make on their own websites, in adverts in magazines, in newspapers, in leaflets and in banner and search ads on the Internet.
We think the ASA has been very patient throughout this tedious process — it must have been a mammoth task for them and no wonder it has taken more than two years. But it's at an end now.
They have carefully examined all the evidence provided to them, rightly applying the same standards as they do to other advertisers, and have come to a decision that is no different to what we have known for a long time: there is no evidence of a sufficiently high standard for homeopathy that substantiates any claims for any medical condition.
To now make any such claim will be a breach of the rules.
Homeopaths must now understand that they have to live up to their responsibilities and abide by the CAP Code, ASA guidance and rulings and stop claiming that homeopathy is effective for any medical condition or other misleading claims.
But no one should misunderstand or misinterpret any of this: no one is stopping any homeopath from practising — not us; not the complainants; not the ASA. This isn't about stopping anyone calling him/herself a homeopath, earning a living from homeopathy, selling homeopathic products and it does not stop anyone from visiting a homeopath or buying these products and services if that's what they want to do.
What this is about — and what this is only about — is ensuring homeopaths comply with the same rules all other advertisers have to abide by.
Additionally, the ASA did not ask us our opinion of the evidence; nor did we expect them to. The ASA are perfectly capable of assessing scientific evidence and making these decisions themselves.
Now that the ASA's position is settled, we look forward to all homeopathy advertisers realising that they have no choice any more but to live up to their responsibilities and comply with the ASA's rulings and guidance and cease making misleading claims. The ASA's free Copy Advice Service might be useful.
We hope homeopaths will follow the good example set by the SoH and that the other homeopathy trade bodies will quickly follow suit and boldly face up to their responsibilities, issue clear instructions to all their members that they must abide by the ASA's guidance. And they must enforce it. No ifs; no buts; no woolly weasel words; no disclaimers; no abdication of responsibilities.
The public has been misled for long enough. It's time to stop.
03 July 2013
Nearly three years ago, a homeopathy advocacy group calling themselves H:MC21 (Homeopathy: Medicine for the 21st Century) placed an advert in the New Statesman. It attracted six complaints to the Advertising Standards Authority (ASA) about claims it made.
Rarely had I seen an advert so inaccurate and borderline libellous in a respected publication. The advert, which appeared to breach the British Code of Advertising, was by a lobby group called Homeopathy: Medicine for the 21st Century (H:MC21). It contained unjustified attacks on myself and colleagues, including statements that gave a dangerously false impression of homoeopathy's therapeutic value.
The ASA adjudicated on 12 points and their Council upheld seven of them. It was published on 5 October 2011.
H:MC21 requested a review of this decision by the Independent Reviewer, Sir Hayden Phillips. During the lengthy appeal process, the adjudication was removed from the ASA's website as is normal practice.
H:MC21 submitted a large number of points to be considered by Sir Hayden. After carefully considering these, he asked the ASA to re-assess the adjudication on some points. This they did and, because we were one of the six complainants, we now have the revised draft adjudication that will be presented to the Council and will be published shortly. However, because it has not yet been published, we cannot divulge any details. The ASA Council's new decision in now final, although H:MC21 say they would like to raise 'a fighting fund' to challenge it.
Suffice to say, H:MC21 have organised a protest outside the ASA's offices followed by a lobby of Parliament on Tuesday 25 June.
They have also asked supporters to write to their MP and local press, claiming that the ASA is not judging them fairly, is effectively denying patient choice and requesting that "this issue be raised in Parliament". They claim that the ASA:
…is not basing its decisions on "the available scientific knowledge" [for homeopathy]…Instead of looking at all the evidence in context, the ASA appears to be making decisions on the basis of a narrow ideological position. This position is in contradiction to scientific knowledge, in contradiction to the paradigm of evidence based medicine (EBM) and in contradiction to good medical practice.
They ask their supporters to tell their MP that they consider the ASA's approach to be:
…dangerous to the health of patients.
Our supporters will recognise the kind of arguments H:MC21 are trying to use and we doubt any critical-thinking MP would be persuaded by them as many are simply fallacious or have nothing to do with the question at hand: is their advert 'legal, decent, honest and truthful' and can the advertiser substantiate their claims?
Although we believe most MPs will be well aware of the independence, impartiality and well-deserved reputation of the ASA and will therefore not take what H:MC21 are saying about the ASA seriously, there is a possibility that they will be influenced by their constituents' emails.
So, we would like our supporters to contact their MP to make sure they are aware of the professionalism and impartiality of the ASA and their ability to critically evaluate scientific evidence.
Mass identical emails to MP are seldom effective, so we would like our supporters to write a short individual email.
Please use your own words as they will have the greatest impact, but to help, we would like to suggest a few points you might like to mention:
You can write to your MP directly, or use the convenient Write to Them website: all you have to do is enter your postcode below and click on Submit and you will be taken directly to the Write To Them website.
The protest and lobby are next Tuesday, so try to get your email sent before then!
If you see any letters or articles in your local press, please also consider replying to those.
20 June 2013
As previously reported, we won an Advertising Standards Authority (ASA) adjudication against the Royal London Hospital for Integrated Medicine (RLHIM) for claims they were making in their leaflet on hypnosis and an informally resolved case over their marigold therapy leaflet.
We have now had another complaint upheld — this time against claims in their leaflets on acupuncture.
Like the other complaints we have submitted, this one has taken a long time to resolve. Over two years, in fact.
Their Traditional Chinese Acupuncture leaflet claimed:
Who can benefit from TCM acupuncture?
Some of the conditions we treat include:
• Women’s health, including disturbances of the menstrual cycle, gynaecological disorders
• Men’s health, including prostatitis, urinary disorders, fertility
• Emotional issues, stress, anxiety, depression, addictions
• Headaches, migraines, tinnitus, dizziness, vertigo
• Sleep disturbances
• Immune system imbalances, allergies, Herpes zoster (Shingles)
• Gastro-intestinal conditions
• Musculoskeletal problems including joint pain, back pain
• Upper respiratory disorders e.g. sinusitis, asthma
• Hypertension (High blood pressure)
Their Group Acupuncture leaflet claimed:
At the Royal London Hospital for Integrated Medicine, Group Acupuncture Clinics are offered for:
• Chronic Knee Pain (including knee osteoarthritis)
• Chronic Musculoskeletal pain (including back and neck pain)
• Chronic Headache and Migraine
• Menopausal complaints (including hot flushes)
• Facial Pain
The RLHIM tried to defend the claims they were making in both leaflets and submitted 43 papers for the ASA and their expert to consider:
Through a Freedom of Information Act request, we now know what these documents were and we have some of the correspondence.
These documents covered chronic knee pain, chronic musculoskeletal pain including back and neck pain, chronic headache and migraine, menopausal complaints including hot flushes, overactive bladder syndrome, facial and dental pain, insomnia and medically unexplained physical symptoms.
They covered several conditions that they hadn't made claims for and certainly didn't cover all the ones they were making claims for! And we never questioned whether acupuncture was cost effective.
The ASA rejected some of the documents, saying:
- …we considered that, because those papers examined the cost-effectiveness rather than the efficacy of acupuncture as a treatment for conditions, the papers were not adequate evidence on which to base claims of efficacy for acupuncture
- We noted that RLHIM also provided a copy of NICE's guidance in relation to low back pain, which was a guidance document for NHS doctors. We understood that that document recommended acupuncture as a possible treatment option for patients with low back pain, but considered that it did not constitute adequate evidence on which to base claims of efficacy for acupuncture.
- We noted the contents of the BMJ article on evidence based medicine but it did not constitute evidence in support of the advertising claims.
Even though they tried to submit it as evidence, the NICE guidance on lower back pain  has been much criticised [2-4].
Although not published until well after the leaflets, the RLHIM submitted the 2012 Vickers et al. meta-analysis.  Because evidence cannot be 'back-dated', it was inadmissible as evidence for the claims they had made. Besides, this paper has been roundly criticised and has been grossly misrepresented by proponents of acupuncture. 
There were several other papers provided that were not published until after the leaflet and were therefore inadmissible.
The RLHIM offered to remove some of the claims:
RLHIM agreed that some of the claims in [the Traditional Chinese Acupuncture leaflet] could not be substantiated and offered to make amendments to or to remove some of the claims. They proposed to amend the claim relating to women's health so that it would not refer to disturbances of the menstrual cycle or gynaecological disorders but instead would state "Women's health, including hot flushes and period pain". They also offered to remove all other claims in [the Traditional Chinese Acupuncture leaflet] except for references to headache and migraine, sleep disturbances, and musculoskeletal problems including joint and back pain. They proposed that they would add the claim "improved wellbeing in chronic illnesses".
The ASA acknowledged RLHIM's offer to:
…remove references to a number of conditions from the the Traditional Chinese Acupuncture leaflet because they agreed they could not be substantiated by evidence, including; disturbances of the menstrual cycle, gynaecological disorders, men's health issues including prostatitis, urinary disorders and fertility, emotional issues, stress, anxiety, depression, addictions, tinnitus, dizziness, vertigo, immune system imbalances, allergies, Herpes zoster (Shingles), gastro-intestinal conditions, upper respiratory disorders such as sinusitis and asthma, and hypertension (high blood pressure). Because we had not seen evidence to substantiate the efficacy of acupuncture for those conditions, we concluded those claims were misleading. We welcomed RLHIM's willingness to remove those claims from the ad.
RLHIM had proposed to include in [the Traditional Chinese Acupuncture leaflet] a statement that acupuncture could provide “improved wellbeing in chronic illness”. We considered general claims that acupuncture could help “wellbeing” would not be problematic, but by linking “wellbeing” to “chronic illness” the statement implied that acupuncture could improve the conditions of patients with all types of chronic illnesses. We noted we had seen only limited evidence relating to a few types of chronic illness, much of which was not sufficient to support specific claims relating to those illnesses. We therefore concluded we had not seen evidence to support the proposed claim.
The ASA assessed the evidence provided for the remaining claims:
Of the remaining 35 papers, we assessed 15 and the remaining 20 were sent to an independent expert for their further assessment. Four of the papers sent by RLHIM were systematic reviews of acupuncture studies, undertaken by the Cochrane Collaboration. We understood that there were further systematic reviews of acupuncture studies by the Cochrane Collaboration which were relevant to the claims in the ads; we also sent those to the expert for assessment.
Missing out relevant evidence is never a good idea.
The ASA and their expert assessed the evidence and found serious issues with just about all of it as substantiation for the claims that the RLHIM had made.
Some examples of the flaws the ASA found with the evidence provided:
Because the paper was published after [the leaflets] were published, we concluded it could not be used as evidence for the advertising claims; notwithstanding that, we also considered that because the study participants were all breast cancer patients, it was not adequate evidence on which to base future general claims about the efficacy of acupuncture for menopausal hot flushes in otherwise healthy women.
We noted the review called for further trials and, furthermore, were concerned with its methodological rigour; it included five unpublished graduate dissertations, the majority of included RCTs were rated as having only a ‘fair’ methodological quality, and only eight of the included trials had any form of blinding.
We understood that those RCTs, and the RCTs included in the systematic reviews, only included patients with osteoarthritis of the knee, rather than those with other conditions which might cause knee pain.
With regard to shoulder pain, the expert concluded that although the two RCTs suggested acupuncture might be beneficial, the evidence from the Cochrane review conflicted with those findings, and therefore further well-designed studies were needed to confirm whether acupuncture was effective.
The expert identified that there may have been recruitment bias and anyway considered that because the Chinese medicine arm of the trial included a range of treatments rather than acupuncture alone, it was not suitable as evidence to support claims relating to acupuncture alone as a treatment for facial pain.
Some studies did provide some evidence for the short-term relief of some conditions, but, because the leaflets did not restrict the claims to short-term relief, the ASA did not consider they had provided the necessary evidence.
It is not clear why it was thought that such obviously flawed evidence would have been acceptable to the ASA. We can only assume — particularly given the length of time this investigation has taken and the prominence of the RLHIM — that they will have provided all the evidence they were able to find in an attempt to defend the claims. Even if they provided inadequate evidence at first, they had ample opportunity to submit better evidence to support their claims.
In summary, the RLHIM:
The ASA's adjudication is lengthy, running to some nine pages and four-and-a-half thousand words. In it, they carefully consider each of the claims made and whether the evidence provided was sufficient to substantiate them.
This adjudication now sets the standard for acceptable claims made for acupuncture and we expect to see the ASA's advice on acupuncture updated fairly soon.
Because all the claims in both leaflets were taken together as one point to be adjudicated on, there was just three breaches of the CAP Code overall:
The ads breached CAP Code rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty therapies).
The ASA concluded:
[The leaflets] must not appear again in their current form. We told RLHIM they should not state or imply that acupuncture was efficacious for conditions for which they did not hold adequate evidence.
The ASA's rules are there to protect the public from misleading claims.
We hope all acupuncturists now get the point.
1 NICE. 2013. “CG88 Low Back Pain: NICE Guideline.” Accessed June 11. http://publications.nice.org.uk/low-back-pain-cg88.
3 “NICE Fiasco, Part 2. Rawlins Should Withdraw Guidance and Start Again.” 2013. DC’s Improbable Science. Accessed June 11. http://www.dcscience.net/?p=1542.
4 “The NICE Fiasco, Part 3. Too Many Vested Interests, Not Enough Honesty.” 2013. DC’s Improbable Science. Accessed June 11. http://www.dcscience.net/?p=1593.
5 Vickers AJ, Cronin AM. 2012. “Acupuncture for Chronic Pain: Individual Patient Data Meta-analysis.” Archives of Internal Medicine 172 (19) (October 22): 1444–1453. doi:10.1001/archinternmed.2012.3654.
6 “An Acupuncture Meta-Analysis.” 2013. Science-Based Medicine. Accessed June 11. http://www.sciencebasedmedicine.org/index.php/an-acupuncture-meta-analysis/.
12 June 2013