When I discovered a homeopath admitting on camera that she believed she and her fellow homeopaths had managed to unblind a triple-blinded homeopathy trial they were taking part in, I submitted a complaint to the journal that published the paper on the trial, the university of the researcher who had conducted the trial and the current university of the homeopath who had subsequently moved into research.

The paper concerned is the 2004 paper by Weatherley-Jones et al. A randomised, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome. This was published in the Journal of Psychosomatic Research.

The homeopath was Clare Relton, currently Senior Lecturer in Clinical Trials at the Centre for Primary Care and Public Health at Queen Mary University of London and Honorary Senior Research Fellow, School of Health and Related Research at the University of Sheffield.

She gave a presentation at the 2019 conference of the Homeopathy Research Institute. Billed as an International Homeopathy Research Conference, it was subtitled, Cutting edge research in homeopathy. The videos of the conference were sponsored by homeopathy manufacturing giant, Boiron.

My complaint email (see below) explains what I discovered and sets the context. As a result of the investigation by the journal, the current editor along with two former editors have just published a peer-reviewed paper on my complaint and their investigation:

When is lack of scientific integrity a reason for retracting a paper? A case study

Misconduct and unethical behaviour

It's worth noting how serious the Journal of Psychosomatic Research considered the misconduct they identified by Relton and others. From the Results section of the paper:

We found the presentation by Dr. Relton disturbing on multiple grounds. This admission of unethical behavior calls her scientific integrity into question. The premise for her actions rests on an errant assumption widespread among clinicians, based on anecdotal experience, that one possesses an ultimate knowledge of what works and doesn’t work without the need for rigorous study. The history of medicine, unfortunately, has been littered by countless treatments that practitioners believed in and dispensed, only to be later found not beneficial or even harmful [4]. This underscores the importance of rigorous study for treatments where equipoise exists in the scientific community, as it arguably did for the use of homeopathy for chronic fatigue syndrome. Dr. Relton likely did not hold that equipoise herself, but if she had ethical concerns about the study, the appropriate action would have been to not participate in it. Instead, she purports to have enlisted colleagues to deliberately and systematically undermine the study.

In watching the presentation, the purpose of this admission seemed to be to discount the results of a rigorous but essentially negative study in the context of promoting her own ideas related to trial design. While we cannot know for certain that her motivation was to discount the results of this study, what she said clearly seeks to undermine the credibility of a trial whose results challenged her firmly held but untested beliefs about the benefit of a treatment that she had high allegiance to. Regardless of her intent or what actually happened during the trial, Dr. Relton’s presentation is ipso facto evidence of either an admitted prior ethical breach or is itself an ethical breach for the following reasons. Either she indeed undermined an ambitious effort to study of the efficacy of homeopathy for chronic fatigue syndrome, negating the work of all other investigators, study staff, and participants involved in the study as well as the investment of the public, or she is conducting a late and inappropriate attack on the study’s credibility. Her presentation certainly warrants formal censure from the scientific community, and this paper may contribute to that. Despite this clear indictment, after discussing and considering the complaint of Mr. Henness for several months, we ultimately decided not to retract the paper.

They decided not to retract the paper but instead use it for ethical reflection. However, they concluded I had highlighted "undisputable evidence of scientific misconduct" by the homeopaths concerned:

When is lack of scientific integrity a reason for retracting a paper? A case study

Objective: The journal received a request to retract a paper reporting the results of a triple-blind randomized placebo-controlled trial. The present and immediate past editors expand on the journal's decision not to retract this paper in spite of undisputable evidence of scientific misconduct on behalf of one of the investigators.

Methods: The editors present an ethical reflection on the request to retract this randomized clinical trial with consideration of relevant guidelines from the committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE) applied to the unique contextual issues of this case.

Results: In this case, scientific misconduct by a blinded provider of a homeopathy intervention attempted to undermine the study blind. As part of the study, the integrity of the study blind was assessed. Neither participants nor homeopaths were able to identify whether the participant was assigned to homeopathic medicine or placebo. Central to the decision not to retract the paper was the fact that the rigorous scientific design provided evidence that the outcome of the study was not affected by the misconduct. The misconduct itself was thought to be insufficient reason to retract the paper.

Conclusion: Retracting a paper of which the outcome is still valid was in itself considered unethical, as it takes away the opportunity to benefit from its results, rendering the whole study useless. In such cases, scientific misconduct is better handled through other professional channels.

Ethical misconduct

The authors had additional ethical concerns:

Apart from the intention of ‘circumventing the blind’, there is another unethical aspect to the behavior of Dr. Relton, namely the fact that patients were systematically subject to an intervention (carcinosin administration) that was not part of the original research protocol and to which they did not consent as part of the study. Although the systematic administration of carcinosin was not part of the study protocol, it was administered only to patients taking part in the study, and because they took part in the study. Presumably, these patients were not properly informed, or maybe even misinformed, about the rationale of a double-blind trial design and/or the true reason for administrating carcinosin. Apparently, ‘deep listening and deep understanding’ does not necessarily need to be accompanied by an honest and open attitude towards patients that participate in research. Dr. Relton stated in her lecture ‘I’m not trained to be deceiving people’, but that is exactly what she did. Not only did she deceive patients, but also the researchers and study leaders that she is supposed to collaborate with as a colleague. [emphasis in original]

Sanctions

The authors said:

The authors are of the opinion that in case the misconduct was not conducted by or on behalf of the principal investigator - as is the case here -, the initiative for further action should lie with them. Not only is the principal investigator the one that was deceived, but they are in a better position to report the misconduct to the institution and funding body. If the principal investigator is responsible for the misconduct, the editor is probably the only one that can initiate further action, in which case the researcher’s institution should be informed and requested to take appropriate action.

It will be interesting to see what further action, if any, is taken by Weatherley-Jones as is suggested.

I had already brought my concerns to the attention of both the University of Sheffield and Queen Mary University of London. The former concluded:

This is to confirm that the University of Sheffield has now completed its assessment of this matter, and it has been agreed that it would not be appropriate for the University of Sheffield to undertake a research misconduct investigation of the allegation against Clare Relton, since she is not a current member of University staff, nor was she a member of staff at the time of the clinical trial in question.

In relation to the potential concerns about the reliability of the published research findings, the University is satisfied that the Journal of Psychosomatic Research is consulting with the authors and taking steps to address the concerns as appropriate. The University will therefore be taking no further action.

I received no response from Queen Mary University of London, despite their Principal being copied in on all the relevant correspondence.

I will be writing again to both and Weatherley-Jones now the paper has been published.

Acknowledgements

My thanks to Jess G. Fiedorowicz, Editor, Journal of Psychosomatic, for his thorough investigation of my complaint.

My complaint

Hi

The results of a trial were published in the Journal of Psychosomatic Research in 2004 (see attached copy):

A randomised, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome

doi:10.1016/S0022-3999(03)00377-5

Elaine Weatherley-Jones a,*, Jon P Nicholl a, Kate J Thomas a, Gareth J Parry a, Michael W McKendrickb, Stephen T Green b, Philip J Stanley c, Sean PJ Lynch d

a Medical Care Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK
b Communicable Diseases Directorate, Royal Hallamshire Hospital, Sheffield, UK
c Seacroft Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK
d St. James’s University Hospital, University of Leeds, Beckett Street, Leeds, UK

* Corresponding author. Tel.: +44-114-222-0744; fax: +44-114-222-0749.
E-mail address: e.weatherley-jones@sheffield.ac.uk (E. Weatherley-Jones)

The paper is indexed in PubMed here.

Elaine Weatherley-Jones is listed as the Corresponding author at the Medical Care Research Unit, School of Health and Related Research, University of Sheffield as are others.

One of the homeopaths involved in providing treatment was Clare Relton, currently Senior Lecturer in Clinical Trials at the Centre for Primary Care and Public Health at Queen Mary University of London.

The full list of those involved in providing treatment during the trial is given as:

The Homeopathic Trials Group: Homeopaths— Gill de Boer, MBChB, MFHom, Maryjoan Foster, RSHom, Susanne Hartley, RSHom, Jane Howarth, BRCPHom, Pat Mayborne RSHom, Georgina Ramsayer RSHom, Clare Relton, RSHom, Pat Strong, MBBS, MFHom, Angela Zajac, BSc, RSHom, BRCPHom.

Dr Relton gave a talk at the Conference in London of the Homeopathy Research Institute held 14 to 16 June 2019. The video of her talk has recently been published: https://www.hrilondon2019.org/films/#clip=eitxmhl1ilss. I have a copy of this video.

I invite you to watch all 30 minutes of it.

At about five minutes in, she begins to discuss the above trial, having just said she was a non-medical homeopath at the Wellforce Clinic in Sheffield. She is currently listed as Chair of Directors.

She then goes on to describe how she took part as one of the homeopaths in the trial and relates how she came up with "a cunning way of circumventing the blinding".

I offer the following transcript of the segment of her talk where she discusses this (all transcription errors are mine):

Timestamp 05:12

So while I was still a homeopath in the Wellforce clinic, a researcher from the University of Sheffield which was actually only five minutes away from my clinic which was really handy came along and said, “I've got some money from Lord Sainsbury to do a trial of chronic fatigue syndrome of homoeopathy” and she described the design and I remember thinking, “not sure what that's going to show”.

But anyway there were ten homeopaths recruited in Sheffield and Leeds and we saw patients with chronic fatigue syndrome.

A lot of us were getting patients with chronic fatigue syndrome anyway and particularly if they were never been well since glandular fever couple of doses of carcinosin 30 or 200 and they seem to make a really good recovery.

So we're pretty confident about taking part in this trial.

So there were 130 or 140 patients recruited to the trial and then allocated to the homeopaths: there were five at our clinic and I was one of them.

Patients would arrive; you would do the normal thing, have the consultation with them. They seemed a bit standoffish, they were quite distant - I couldn't work out why.

And then at the end of the consultation I had to say to them “well there’s a 50% chance that whatever I prescribe you is going to be a placebo”, which sort of sort of lowered the temperature in the in the in the Consulting room because you know they came because they have chronic fatigue; they came... didn't come because they wanted to take part in an experimental game.

So we would ring the pharmacy up and tell them our prescription. Helios Pharmacy would then send out either placebo or the real remedy according to the allocation of the patient.

The patient would come back four weeks later and if they were better, great and if they weren't it was really, really difficult. So, had I got the wrong prescription or were they on placebo?

So after about six months of this we started working out there was a cunning way of circumventing the blinding and we worked out, well if we give them all a dose of carcinosin they're going to have some reaction: there’s going to be a dream there’s going to be some change and if when they come back at the second appointment they haven't changed then we know they’re on placebo. So don't bother doing all that trying to find the right remedy; just use all your other amazing skills you have as a homeopath: the deep listening we have the deep understanding of what we know about what's toxic in our systems, about diet and counselling.

So that's what we did. Because we're homeopaths. We’re trained to treat people I'm not trained to be deceiving people. That's what I do, that's what I did then; that's what all my colleagues did.

So ok, so the trial ended and at the end the results came out I'm sure quite a few of us are familiar with it.

There were two groups, so there was a group... everybody in the patient… everybody in the trial received treatment... a course of treatment by a homeopath and 50% of them received a placebo remedy 50% the real remedy, the verum.

And the results... both groups got better and the group that received the real remedy improved better than the group that received the placebo but was the difference clinically significant? Not quite. How many trials do we have that? So this trial was so much realisation, so many questions came out of my experience being inside, inside a double-blind placebo randomised controlled trial. What is seen as the... you know the... summit of evidence-based medicine in terms of rigorousness, I  just thought “what is this doing?” I don't know what... I don't know what this has shown.

This is what’s called an explanatory trial and I thought well it’s explaining nothing to me, apart from the fact that the system for designing and conducting randomised controlled trials at the moment isn't working.

So lots of questions.

Timestamp 09:02

The paper states:

Patients were successfully blinded to their group allocation, and therefore we have assumed that whatever the reasons for nonresponse, they are the same for the treatment arm and the placebo arm and that the data are comparable. Therefore, intention to treat analyses was done on actual data plus imputed missing item data, but all unit missing data were excluded from analyses.

and:

Checking of double blinding showed that prediction of treatment group was made by neither homeopaths (j =. 07, P c.60) nor patients (j = 0.11, P c.48).

The trial was of a triple-blind design but there is no mention of the deliberate attempts to circumvent the blinding in the paper. The effects on participants by the actions - inadvertent or otherwise - of Relton and her colleagues are not considered and not known.

I believe the actions of Relton, the other four homeopaths at her clinic whom she clearly implicates in this circumvention of blinding, and possibly the remaining four homeopaths if they were all known to each other and in contact with each other since they were all in the same area of Leeds/Sheffield, compromised the trial design, rendered the results unreliable and seriously undermined the integrity of the paper and its conclusions. I do not believe it matters whether or not they were in fact able to circumvent the blinding, but it does matter that Relton and others believed they had because she admits it led to different behaviour on their part resulting in contamination of the results.

I believe the actions amount to misconduct.

I note additional criticism of this paper by Prof Edzard Ernst (see attached).

I ask that Sheffield University investigate this matter and that along with Queen Mary University of London and the Editor-in-chief of the Journal of Psychosomatic Research, Jess Fiedorowicz, MD, PhD, decide what actions to take. I ask that consideration is given to retracting this unsound paper.

Please consider this email as a formal complaint against Dr Clare Relton and others.

Please acknowledge receipt by return and keep me informed of your progress in investigating this matter and of your conclusions and outcome.

If you require any further information, please do not hesitate to contact me.

Best regards.
Alan Henness

16 March 2021

England

Continuing its decline, the number of prescriptions for homeopathy products dispensed in community pharmacies in England plummeted 25% in 2017 to just 5,105. The cost to the NHS of these prescriptions dropped 32% from £92,412 to £62,124, according to data published two weeks ago by NHS Digital, further cutting the income and profit of manufacturers.

The number of prescriptions is now just 3% of what it was at the height of its popularity in the mid-1990s.

The decline is to be expected given the ending of funding by CCGs in Liverpool, the Wirral, Enfield and elsewhere.

The effects of more recent guidance to CCGs by NHS England to end the funding of homeopathy will add to the woes of homeopaths this year. CCGs in Bristol are currently consulting (for a second time) on the ending of funding of homeopathy, but we would expect them to follow the same path as other CCGs and NHS England. NHS England has also recommended that the Department of Health add homeopathy to the blacklist of products the NHS provides.

The admission a few weeks ago by the Royal London Hospital for Integrated Medicine that they would no longer be providing homeopathy consultations or dispensing NHS homeopathy prescriptions can only be a further source of acute embarrassment to what used to be homeopathy's NHS flagship.

Scotland

The NHS in Scotland collects their data on a different timescale, publishing data for the previous financial year rather than the calendar year of the NHS in England. The latest data for Scotland was published last September, covering the year to April 2017 (in the chart, the data are assigned to the year of the start of the period).

Wales

Primary Care Services Wales also publish prescription data. Selecting homeopathy (by BNF chapter, section, subsection 19, 02, 03) gives:

Curiously, in 2017, the only item categorised as homeopathic is called Zota Swedish Bitters. This appears to be a herbal product, not homeopathic, but it is the only item listed last year (and the few other months' data going back to 2015 we checked) under the BNF section for homeopathy products. This appears to be an error by the NHS in Wales: either this herbal product has been wrongly categorised as homeopathic or they have simply used Zota Swedish Bitters as some kind of a default text for this field in their database. It could be that they have no homeopathic products at all, but we will assume these are homeopathic — because of the relatively low numbers compared to England and Scotland, they won't make much difference to the overall totals below.

Northern Ireland

The Business Services Organisation of the Department of Health in Northern Ireland publish their own similar data on prescriptions. There was a massive increase in the number of homeopathic prescription items in 2016 compared to previous years: from 2000 to 2015 there had been precisely zero items but this jumped up to two in 2016! These were packets of 'Teetha Homeopathic Granules 7G Sachets Sugar Free Homeopathic Granules 6c'. This is a product manufactured by Nelsons that used to have a Product Licence of Right, but that has now been cancelled by the MHRA. At least this product only contained Chamomile (in a declared dilution of one part in 1,000,000,000,000) and not the Belladonna found in some US products. (A future newsletter will cover suspected adverse events in the UK from homeopathic teething products.)

The United Kingdom

Now we have the data from all the constituent parts of the UK, what does the overall picture look like?

Ignoring the slightly different annual periods, the number of prescription items for the whole of the UK is:

The total cost of these prescriptions amounts to £113,729 in 2017. That is just the cost of the prescriptions themselves and does not include any other costs such as salaries and fixed and variable overheads that the NHS has to bear just to provide these products.

Homeopathy, and the legitimacy given to it by its provision on the NHS, has been diluted and diluted over the years. It's difficult to see how it can ever recover from this decline.

Additional reading

If you are interested in many of the regulatory aspects of homeopathy in the UK as well as in Ireland, the US and India, the blog UK Homeopathy Regulation is an excellent resource and fount of detailed information.

29 March 2018

Complaints

Our complaints arose from a visit we paid to Nelsons Homeopathic Pharmacy in Mayfair, London on 12 May 2015. We were appalled by what we saw there and, in summary, we submitted the following complaints about the pharmacy, their pharmacy website and their Nelsons Natural World website, each complaint following the previous because we felt they were not dealt with properly:

Complaint 1: 28 May 2015 Joint complaint to the MHRA and GPhC about Nelsons' pharmacy and website.

Complaint 2: 28 July 2016 Second joint complaint to the MHRA and GPhC about Nelsons' pharmacy.

Complaint 3: 28 November 2016 Third joint complaint to the MHRA and GPhC about Nelsons' pharmacy.

For the background to all this, see:

Nelsons Homeopathic Pharmacy #1

Nelsons Homeopathic Pharmacy #2

Rubbing salts into the wounds of homeopathy

So far, so good. But a major part of our complaint about Nelsons Homeopathic Pharmacy concerned the General Pharmaceutical Council (GPhC), the regulator for pharmacists and pharmacies. 

Our complaint was submitted to both the GPhC and the medicines regulator, the MHRA, in May 2015. We weren't sure what specific aspects each would deal with and neither, it seems, did they. The GPhC had to discuss the case with the MHRA and decide what their remit was and took legal advice.

What were we complaining about?

Our complaint covered a number of issues that concerned us (including the kits of homeopathic products that were on sale, tissue/cell salts, point of sale (POS) advertising, various herbal products and their price list) but we will focus on the main one here: on our first visit to Nelsons premises, Maria self-selected a tube of a homeopathic product labelled 'Diarrhoea'.

Why was this a problem?

This product is not registered and not authorised by the MHRA. As such, it is essentially an unlicensed medicine (technically, the MHRA had not determined its status but it clearly was not a registered and not an authorised homeopathic product), it should not have had indications (in this case diarrhoea), should not have been advertised, should not have been available for self-selection by a customer and should not have been sold other than in very limited circumstances — more on that later.

This tube was just one of many:

The labels on the front of the boxes tells us they contained homeopathic products for:

[row][column size="1/3"]Aching legs
Acidity & heartburn
Alert mind
Arthritis & Rheumatism
Back ache & sciatica
Bites and stings
Bloating
Boils & carbuncles
Catarrh
Chesty cough
Cold sore relief
Computer eye strain
Concentration
Constipation[/column] [column size="1/3"]Cystitis
Detox support
Diarrhoea
Dizziness
Dry cough
Flu relief
Food poisoning
Gout relief
Grief and Bereavement
Haemorrhoids
Hangover
Hayfever & allergy
Healing combo
Healthy hair[/column] [column size="1/3"]Jet lag
Lactation blend
Mastitis
Menopause relief
Mens [sic] health
Migraine headaches
Morning sickness
Mouth ulcers
Nervous anxiety
Post flu tiredness
Rheumatism
Sports injuries
Womens [sic] health
Youthful skin[/column][/row]

That's quite a list of medical conditions, but the one we selected was labelled:

NELSONS HOMEOPATHIC PHARMACY
SINCE 1860
DIARRHOEA
Relieves symptoms of diarrhoea & vomiting due to consumption of unwashed fruits, vegetables, bad meat or fish.
Take 2 pills every hour until better.
Arsenicum 30C, Podophyllum 30C, Pyrogen 6C, Carbo Veg 30C, Nux Vom 30C
Expires End 06/18
Batch D1653 Approx 84 PILLS
Take away from food and drink
Keep out of the reach of children
CONSULT YOUR PRACTITIONER IF SYMPTOMS PERSIST 

That is a very bold therapeutic claim: as well as breaching the medicines regulations, we believed this was highly irresponsible. Note that it doesn't say to consult your GP if symptoms, just your (homeopathic) practitioner.

Ingredients

The most interesting ingredient here is the Podophyllum: also known as May Apple, Devil’s Apple, Wild Lemon and Indian podophyllum, it is a herbaceous perennial plant in the family Berberidaceae, and is poisonous. As such, it is designated as a banned and restricted herbal ingredient by the MHRA and medicines containing it are classed as Prescription Only Medicines (POM).

The label on the diarrhoea product claims it is diluted to 30C, that is, one part in 1,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000, but, of course, that depends on it having been properly manufactured. The MHRA decided it wasn't a POM because it was diluted so much.

That out of the way, the GPhC turned to dealing with our complaint.

Eventually, in February 2016, we were told the case was going to be sent to their Investigating Committee. It took a while to get our witness statements sorted out but they eventually took our statements, our full complaint, the video we had taken and the MHRA's decision to their committee. We didn't get their decision on the complaint until May 2016, one full year after we had submitted our complaint. They said:

The GPhC has reviewed all of the available information and we have concluded that the matter you have made a complaint about is not a matter that requires regulatory action. Accordingly this case file has been closed.

Considering the seriousness of the issues we complained about, we found this dismissal astonishing. However, the four reasons they gave for this decision were, we believed, entirely spurious and erroneous:

1. There is no requirement for the pharmacist to identify herself, other than to display an Responsible Pharmacist notice. The video you supplied shows the Responsible Pharmacist notice behind the person serving Ms MacLachlan. In addition, the pharmacy produced the Responsible Pharmacist log to the GPhC confirming the pharmacist who was on duty that day.
2. The medicines were not used inappropriately and no harm was caused.
3. There is no information to suggest the sale and display of homeopathic medicine was in breach of any legislations [sic].
4. The issue regarding the leaflets is a matter for the advertising unit of the MHRA, but do not breach regulations relating to the sale and supply of POMS.

The incompetence here is quite astounding. Addressing each of these points briefly (and this really didn't cover all of our complaint):

1. This was irrelevant because Maria was sold an unauthorised medicinal product by someone who wasn't a pharmacist and without a prescription. We had never questioned the identity of the pharmacist.
2. Goodness knows what they deemd appropriate use of the sugar pills, but we never said — and were never asked — whether we had taken any of the product or whether we had been harmed, so we had no idea how the GPhC had arrived at their conclusion.
3. We provided clear video evidence of the multiple breaches — and they could easily have verified it with a site visit if they had wanted — so we are at a loss to understand this.
4. None of the homeopathic products were POMs but were unauthorised medicines.

We complained again, taking apart this wholly inadequate decision, and this was passed to the investigator's line manager to deal with. We got his response a few months later in July 2016. It was confusing and totally unhelpful in understanding the original decision and simply raised more questions than it answered.

It really did beggar belief that a statutory regulator could have produced such a sloppy and ill-reasoned response.

Needless to say, it essentially upheld the original decision. However, on the point of the unauthorised medicines being on sale, the manager decided there was now enough evidence and has issued 'formal advice' to the Superintendent Pharmacist at Nelsons, Suzanne Haar — this was to be kept on record and referred to whenever the site is next due for a routine inspection. We were not given a copy of this advice despite attempts to find out so we could better understand the legal position regarding these unlicensed products.

Complaint 2

Because we were completely unsatisfied with this response, we paid Nelsons another on 28 July 2016. Guess what Maria was able to purchase? Exactly the same diarrhoea product she did the first time. We also noticed the same unauthorised products on sale as well as unauthorised tissue salts products. Perhaps the most galling thing was that the booklet Which remedy do I need? that was banned by the MHRA from Holland and Barrett was still there despite that being part of our complaint. It's not believable that Nelsons were not aware of our three MHRA complaints on this and the MHRA's decision.

It appears that despite our complaints to the MHRA and the GPhC and despite their investigations and the formal advice given to them, absolutely nothing had changed.

So, we responded to both the MHRA and the GPhC again with all we found and we were told that they were both considering this as new complaints against Nelsons and the pharmacist/pharmacists.

As we said in the last instalment, we kept it as a joint MHRA/GPhC complaint because we didn't want anything to fall through the cracks. We have copied correspondence to both regulators throughout: that seems to have been a wise move. We said:

We're sure you will be as concerned and as disappointed as we are that despite previous rulings that the POS [Point of Sale] material was not permitted and despite your previous action, this and other materials are still being used and that unauthorised medicines are being displayed and sold. It is difficult to understand why these obvious breaches have not been properly addressed by all concerned long before now and that we have had to submit a further complaint.

In summary, our concerns are that Nelsons are still:

1. selling unauthorised medicinal products (with indications) in breach of the regulations.
2. offering for sale on their premises and on their website unauthorised medicinal products (including herbal mother tinctures), many with indications.
3. using point of sale materials that have indications for homeopathic medicinal products for which indications are not permitted.
4. offering for sale Schuessler Salts products with indications in breach of your ruling on this after our previous complaint - I was unable to verify whether they were described as homeopathic or whether their dilution was given in homeopathic terms.
5. offering for sale Dr Reckeweg 'tissue salts' products that are labelled with a 'homeopathic' dilution.
6. advertising in their price list unauthorised medicinal products (including herbal mother tinctures), many of which have indications.
7. advertising in their price list unauthorised kits of homeopathic products with indications.
   …

We sincerely hope that our complaints will now be fully and thoroughly investigated and that any breaches of the regulations are finally dealt with.

 Some of these points relate to the complaint to the MHRA so read the previous newsletter to find out what they are all about. The GPhC seemed a tad confused:

It is unclear at this stage whether these new concerns relate to the same matters that we have addressed in our recent investigation. Once we have conducted a full review of the documentation we will confirm whether we will be opening a new case. We will also consider if any aspects of your new concerns should be referred to the MHRA for further investigation.

It's difficult to understand what was unclear.

While we were waiting for the GPhC to deal with this, we received a reply from the MHRA telling us they had received confirmation from Nelsons that they had taken action to address points 1, 2, 3, 4, 5 and 7. We wanted to check to see what had changed, so we paid them another visit.

Complaint 3

We told both the MHRA and the GPhC:

We are sure you will be as disappointed and frustrated as we are to discover that they still do not appear to have addressed all the issues.

Maria visited the shop this afternoon:

1. She self-selected and purchased yet another tube of 'Diarrhoea Relief' homeopathic product.
2. It is not known whether the member of staff who sold the Diarrhoea Relief product to Maria was a pharmacist or not (but we are certain it was not the Superintendent Pharmacist, Suzanne Haar), but she was asked no questions whatsoever about the product, who it was for or for what medical condition it was being purchased. The till receipt (see attached scan) gives the name 'Marlyn Hap'.
3. The clear plastic boxes of these unauthorised medicinal products with lists of indications on the front were on two shelves in the same place in the shop as before and fully accessible to members of the public.
4. There were two notices attached to the edge of the lower shelf. One said: 'Not for self selection' and the other said: 'Please ask a member of staff for help. Thank you' but it was not clear whether this referred to the products on the shelf to which it was attached or those on the shelf below. The upper shelf of unauthorised medicinal products had no such notices.
5. The 'Which remedy do I need?' wire-bound point of sale promotional material for their registered and authorised homeopathic products was still attached to the rack of products.
6. The Schuessler Tissue Salts products on the shelves gave the potency as a numeric value such as 6X on the front of the label. The display shelving unit (that housed all the above-mentioned products) was labelled 'Homeopathy' at the top.

 This was our third complaint to both statutory regulators about the exact same issues. It has taken eighteen months thus far. We said:

As we said, it was disappointing that we had to submit a complaint the first time (and we would remind you that was on 28 May 2015). The various regulations surrounding the advertising, sale and supply of homeopathic products and unauthorised medicinal products are straightforward and it is the responsibility of the Pharmacists and Nelsons to ensure compliance. We are at a loss to understand why - after eighteen months and two previous complaints about essentially the same breaches - that these issues have not been fully and properly resolved. Your previous actions against Nelsons have clearly been wholly inadequate and it is disappointing that it has been necessary to submit yet another complaint.

We sincerely hope that the combined efforts of the MHRA and the GPhC will - this time - ensure that Nelsons Homeopathic Pharmacy finally comply with all the various regulations they must know they have to comply with.

We also said to the GPhC:

Now that the MHRA has concluded their second investigation and ruled that Nelsons Homeopathic Pharmacy have again breached various regulations concerning the advertising and supply of both unauthorised medicinal products and registered homeopathic products and herbal products, we would ask that you take these into account in your consideration of our previous complaint about the Registered Pharmacists at Nelsons Homeopathic Pharmacy and our further complaint detailed above.

It beggars belief that Nelsons thought that putting up a notice on the shelf saying 'Not for self selection' would be considered anywhere near adequate: the products were still available for self-selection.

Decision

The GPhC eventually referred the case to their Investigating Committee (IC) and a further eight months later in July 2017, we received their outcome. The allegations they considered were:

On 22 June 2017, the Investigating Committee considered the following allegations against Nelsons pharmacy, [Navreet Chaewla and Susanne Haar]:

• From 27 January 2014 to December 2016 the Pharmacy did not move all unlicensed medication as instructed from the front of the premises so that they were not available for self-selection in accordance with:

The action plan issued by the GPhC inspector on 27 January 2014; and

GPhC guidance, as set out in the letter dated 12 May 2016.

• Failed to ensure that the counter staff of Nelsons Pharmacy asked sufficient questions to determine that the treatment is suitable for the patient before the sale is completed

Haar is the Superintendent Pharmacist at Nelsons Homeopathic Pharmacy and, as such, takes responsibility for the way in which a company carries out its professional pharmaceutical activities. The decision they came to included:

In this case, the Investigating Committee decided to issue a warning to Susanne Haar and to give advice to Navreet Chaewla. This means that the Investigating Committee has concluded that the allegations need not be considered by the Fitness to Practise Committee. The Committee felt that it would be appropriate for the matter to be disposed of by the Investigating Committee.

In order to receive the warning, the committee had to adjourn and inform the registrant that that was what they were minded to do and gave the registrant the opportunity to make submissions about the proposed course of action or, if the registrant wished, to have the case heard by the Fitness to Practise Committee. In this case the registrant accepted a warning.

Please note that the letter of warning is a formal sanction that will stay on the registrant’s legal history with the GPhC for 5 years and on the public register for 2 years, and may be taken into consideration if any further allegations are made about the registrant.

We have also shared the outcome of the Investigating Committee with our local inspectors who may consider this as intelligence as part of any future inspection.

The warning placed on Haar's record is:

On 22 June 2017 the General Pharmaceutical Council’s Investigating Committee considered an allegation in relation to Mrs Susanne Skovgaard HAAR, registration number: 2039122 and determined to issue the registrant concerned with a warning in relation to the conduct alleged.

The warning has been issued to ensure public confidence in the profession and the regulatory process and to protect the public by reminding the registrant concerned to adhere to all legal and professional obligations in their practice in the future.

So despite all the issues we found, the multiple failings by Nelsons to abide by the regulations and to heed advice given to them by the regulators, it was not deemed to be a fitness to practice issue.

Although we received this last July, we were waiting for the MHRA to publish their final decision notice, which they did last week.

Three years, a 22-page initial complaint, two further complaints, two statutory regulators, multiple occasions where we had to chase both regulators and multiple occasions where we had to correct their misunderstandings and errors, but we finally got there.

Lessons

We did not do this to have anyone punished: we started this as an attempt to discover and understand precisely what pharmacies and pharmacists were and were not permitted to do in terms of selling homeopathic products and to test the statutory regulators' resolve to enforce those rules and regulations. The failures of Nelsons Homeopathic Pharmacy to implement the guidance provided by the regulators are what have caused this to have dragged on so long. But a complaint should never have been necessary in the first place: understanding the Human Medicines Regulations, the Medicines Act and all the other legislation surrounding the operation of pharmacies are part of the responsibilities of pharmacists. There can be no excuses. It should not have taken one complaint, never mind three, and it should not have taken nearly three years to resolve these very simple and straightforward issues.

What can we learn from this? What can homeopaths and homeopathic pharmacies learn from this? What, precisely, can pharmacies do in terms of selling homeopathic products, whether authorised, registered or neither?

This exercise has revealed a lot about all that, but that's for the next instalment.

26 February 2018

The last time we looked at Nelsons, we told you of our complaint against them that the medicines regulator, the MHRA, upheld. This concerned their advertising on their websites of homeopathy products that were not within the terms of their registrations.

We briefly mentioned that this was part of a larger complaint: our MHRA complaint ran in parallel with another complaint we had submitted to the General Pharmaceutical Council (GPhC), the regulator for pharmacists and pharmacies. That was completed some months ago but we were waiting for the MHRA to announce their decision on their part of that complaint.

Yesterday the publication by the MHRA of their decision on that complaint so we can now reveal that and regale you with the catalogue of errors and mishandling by the GPhC now everything has been properly — and finally — resolved.

We submitted our original complaint on 28 May 2015 — nearly three years ago. It's just as well we are determined and patient!

Although the two stories are closely intertwined, for simplicity, we will detail the MHRA parts of the complaints here and will address the GPhC complaints in a subsequent newsletter. As you will appreciate, this is a long and involved story, but we feel it's necessary to put much of it into the public domain.

Complaints

Our complaints arose from a visit we paid to Nelsons Homeopathic Pharmacy in Mayfair, London on 12 May 2015. We were appalled by what we saw there and, in summary, we submitted the following complaints about the pharmacy, their pharmacy website and their Nelsons Natural World website, each complaint following the previous because we felt they were not dealt with properly:

Complaint 1: 28 May 2015 Joint complaint to the MHRA and GPhC about Nelsons' pharmacy and website. 

Complaint 2: 20 July 2016 Second joint complaint to the MHRA and GPhC about Nelsons' pharmacy.

Complaint 3: 28 November 2016 Third joint complaint to the MHRA and GPhC about Nelsons' pharmacy.

Complaint 1

The MHRA and GPhC took some nine months just to sort out among themselves what parts of the complaint came under their respective remits: it wasn't until January 2016 that the GPhC contacted us to progress the complaint.

However, the website parts of the complaint are the responsibility of the MHRA. They dealt with this and this was what we wrote about in our earlier newsletter: Nelsons Homeopathic Pharmacy #1 in August 2015. Another part of that complaint was about Schuessler Tissue/Cell Salts products that were on sale in the pharmacy. This was also dealt with separately by the MHRA as it raised different issues. For further details, see: Rubbing salts into the wounds of homeopathy and see below.

Although the MHRA upheld these parts of the complaint, they failed to mention what we believed to be issues concerning the pharmacy premises that we understood fell within their remit. We therefore submitted a second complaint.

Complaint 2

The GPhC were still dealing with our first complaint but this is an extract from our second joint complaint, submitted after a second visit to Nelsons. We kept it as a joint MHRA/GPhC complaint because we didn't want anything to fall through the cracks.

We're sure you will be as concerned and as disappointed as we are that despite previous rulings that the POS [Point of Sale] material was not permitted and despite your previous action, this and other materials are still being used and that unauthorised medicines are being displayed and sold. It is difficult to understand why these obvious breaches have not been properly addressed by all concerned long before now and that we have had to submit a further complaint.

In summary, our concerns are that Nelsons are still:

1. selling unauthorised medicinal products (with indications) in breach of the regulations.
2. offering for sale on their premises and on their website unauthorised medicinal products (including herbal mother tinctures), many with indications.
3. using point of sale materials that have indications for homeopathic medicinal products for which indications are not permitted.
4. offering for sale Schuessler Salts products with indications in breach of your ruling on this after our previous complaint - I was unable to verify whether they were described as homeopathic or whether their dilution was given in homeopathic terms.
5. offering for sale Dr Reckeweg 'tissue salts' products that are labelled with a 'homeopathic' dilution.
6. advertising in their price list unauthorised medicinal products (including herbal mother tinctures), many of which have indications.
7. advertising in their price list unauthorised kits of homeopathic products with indications.

…

We sincerely hope that our complaints will now be fully and thoroughly investigated and that any breaches of the regulations are finally dealt with. 

Some of these points relate to the complaint to the GPhC so read the next newsletter to find out what they are all about.

The MHRA duly dealt with this and told us:

We have received confirmation from Nelsons that they have taken action to address points 1-5 & 7 above.

Great. All sorted then…

Complaint 3

However, we paid their premises a third visit and found the 'Which remedy do I need?' wire-bound point of sale promotional material for their registered and authorised homeopathic products was still attached to the rack of products. We also found Schuessler Tissue/Cell Salts products on the shelves that gave the potency as a numeric value such as 6X on the front of the label. These were clearly against what the MHRA had ruled for these products, had told Nelsons and what Nelsons had supposedly addressed, so we had to submit a third complaint.

The MHRA published their decision on that complaint yesterday.

Decision

As we've mentioned before, what the MHRA publishes on their website about the outcome of complaints can, at best, be described as sketchy. We did mention this to the MHRA and we're pleased to see this latest report has significantly more detail:

It has taken them over two months just to publish this,

In their 'final' letter to us for this complaint they gave more details on each of the points we identified above:

Thank you for your email of 28 July 2016 concerning the promotion of homeopathic medicines by Nelsons Pharmacy.

We have been in correspondence with Nelsons and have completed our investigations. We provided the following guidance on our interpretation of the law, numbered as per your original complaint, and requested confirmation that the necessary action has been completed:

1&2 Under Section 10 of the Medicines Act a pharmacist may supply unlicensed medicines when requested to do so by a patient. These products may not be advertised. We also understand from colleagues in Regulatory Advice that unlicensed medicines supplied under section 10 of the Medicines Act should not be available for self-selection.

3 Point of sale material should not promote unlicensed homeopathic remedies or provide indications for those registered without indications.

4&5 Tissue Salts/Schuessler Salts are generally considered to be medicinal products if any of the following appear in promotional material or product labelling:

a. the terms ‘homeopathic remedy’, and/or ‘homeopathy’ and/or ‘homeopathically prepared’

b. a numerical value for the potency e.g. 6X and/or the word ‘potency’ itself

c. indications for use in a medical condition

If they are not licensed or registered and any of the above appear then such products would be likely to be considered unlicensed medicines and should therefore not be advertised. Our advice above would also apply.

6 Any claims for registered/licensed medicinal products must comply with the product SPC, including the specified indication wording for homeopathic remedies and traditional herbal medicines. Listings for unlicensed medicines (including unregistered homeopathic remedies) must not include any product claims.

7 Our advice above will also apply to these products.We have received confirmation from Nelsons that they have taken action to address points 1-5 & 7 above. They have also confirmed that, in line with point 6, all material will be further reviewed and amended as necessary to ensure that all promotional material is compliant with the SPC for licensed/registered medicines by the end of 2016.

Essentially, it took three complaints and several years to get this sorted. Nelsons should now be in no doubt of their responsibilities under the Human Medicines Regulations 2012 (HMR) and the Medicines Act 1968 as they relate to the following distinct areas:

A. The supply, sale and advertising of unauthorised homeopathic medicinal products (as the HMR calls them), ie those homeopathic products that are not authorised under the National Rules (NR) Scheme or not registered under the Homeopathic (Simplified) Rules (HR) Scheme — we can ignore any Product Licences of Right as they effectively no longer exist.

B. The supply, sale and advertising of Schuessler Tissue/Cell Salts.

C. The terms of the authorisation or registration of NR and HR scheme products.

There is more to be said about these, particularly the first one, but we first need to look at our complaints to the GPhC, how they dealt with them and what the outcomes were. We hope to publish that comedy of errors in the few days.

To be continued…

 23 February 2018

Homeopathy is under severe pressure in the UK with what little credibility it had, destroyed. The ending of referrals from GPs in Liverpool and the Wirral over the last year or so and consultations on the future of homeopathy in Clinical Commissioning Groups in Bristol and Enfield, and more recently by NHS England, have piled on top of the decline by 96% of NHS prescriptions for homeopathy in England in the past 20 years.

We have also seen the recent announcement that Weleda (a supplier of homeopathic and anthroposophic products to the NHS) is ending the production of their ‘bespoke’ homeopathic products. The pending outcome of a consultation by the Charity Commission on CAM charities could add yet more woe.

We could be seeing the final death throes of homeopathy on the NHS with possible knock-on effects on the businesses of lay homeopaths: many relying on the false imprimatur leant to it by the NHS.

In November, the Council of the Royal College of Veterinary Surgeons (RCVS) issued a position statement including ‘Homeopathy exists without a recognised body of evidence for its use. Furthermore, it is not based on sound scientific principles.’

This followed a statement in September 2017 from the European Association of Science Advisory Councils, which represents the national science academies of 27 countries, concluding that homeopathy ‘can actually be harmful: by delaying or deterring a patient from seeking appropriate, evidence-based, medical attention and by undermining patient and public confidence in scientific evidence.’

Homeopaths are also under pressure from the Advertising Standards Authority to make sure their advertising is ‘legal, decent, honest and truthful’, but many still seem to have difficulty with those principles. To protect the public from misleading claims, the ASA rightly sets a high standard of evidence — one clearly too high for homeopaths. But the ASA make it easy for homeopathy advertisers, stating: “Practitioners should therefore avoid making direct or implied claims that homeopathy can treat medical conditions.” Crystal clear.

Whether it concerns human or animal health, the debate is clearly about the consideration of the best available scientific evidence; to that battle, homeopaths come unarmed.

After the Bristol Homeopathic Hospital closed in January 2013, homeopathy continued to be provided by a small clinic at the South Bristol Community Hospital. Just three years later, in October 2015, this too closed to be replaced by a private clinic, the Portland Centre for Integrative Medicine. That is not part of the NHS but is contracted by the CCGs to provide homeopathy services.

Now the group of CCGs wants to end all homeopathy referrals to that clinic.

The consultation consists essentially of just two simple questions:

• Do you understand the reasons for our proposal to stop NHS funding for homeopathy treatment? Yes|No
• Do you agree or disagree with our proposal to cease NHS funding for homeopathy? Agree|Disagree

…with the opportunity to explain your answers and provide further information.

The consultation closes next Tuesday, 15 August 2017 so plenty of time to submit your response, but don't leave it too late!

Homeopaths and their trade bodies (including the Faculty of Homeopathy and the British Homeopathic Association) have been urging their members to respond: we know decisions should not be made on the popularity of a treatment but on the best evidence, but the more the CCGs hear about the evidence-based position, the easier it will be for them to make the right decision.

We will be submitting our own comprehensive response to the CCGs and we will publish it later in the year.

There is another consultation running at the moment, this time by NHS England that would effectively blacklist homeopathy, but that doesn't close until October so we'll leave that for another time.

It'll only take you a minute to respond to this consultation: why not do it right now?

10 August 2017

Continuing its inexorable two-decade decline from its peak in 1996, the number of prescriptions for homeopathy products supplied in community pharmacies in England fell by 23% in 2016.

Data released today by NHS Digital show that homeopathy prescriptions fell from 8,894 in 2015 to 6,821 last year, a drop of 96% since its peak in 1996:

This drop is a welcome sign that the NHS continues to understand the need for robust evidence for treatments and that it does not exist for homeopathy. Although the mantra of choice is frequently repeated by supporters of homeopathy, providing a treatment for which there is no good evidence of specific patient benefit does not provide a choice to patients: they deserve better.

The House of Commons Science and Technology Select Committee in its Evidence Check on homeopathy concluded:

157. By providing homeopathy on the NHS and allowing MHRA licensing of products which subsequently appear on pharmacy shelves, the Government runs the risk of endorsing homeopathy as an efficacious system of medicine. To maintain patient trust, choice and safety, the Government should not endorse the use of placebo treatments, including homeopathy. Homeopathy should not be funded on the NHS and the MHRA should stop licensing homeopathic products.

In the most comprehensive review to date of the evidence for homeopathy, the Australian National Health and Medical Research Council concluded:

Based on the assessment of the evidence of effectiveness of homeopathy, NHMRC concludes that there are no health conditions for which there is reliable evidence that homeopathy is effective. Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments. 

With such damning conclusions, patient choice cannot be heralded as sacrosanct. Consumers are perfectly free to buy their own homeopathy products, but it behoves the NHS to provide treatments that are based on robust scientific evidence.

Rising costs

The drop in the number of prescriptions is not matched by a corresponding fall in the total cost of those prescriptions: the number fell by 23% but the overall cost of these prescriptions only fell by 2%. How can this be?

For some reason, the average cost for each homeopathy item jumped by 28% to £13.55 compared to the previous year's £10.60. This is a substantial rise and may have been due to a jump in the cost of raw sugar… or maybe the suppliers wanted to try to compensate for the decreased sales volume? Looking at what happened in 2010, there could be a pattern.

Scotland

The next release of data for Scotland will be in June and will cover prescriptions from 01 April 2016 to 31 March 2017. There's no reason to suppose a similar decline won't be seen there too, particularly given the closure of the final seven in-patient beds at the Glasgow Homeopathic Hospital tomorrow: the legitimacy given to homeopathy by the NHS is slowly but surely being removed.

Popularity

Proponents of homeopathy frequently state that it's used by 10% of the population. They usually don't cite any evidence to substantiate that figure, but it could come from the statement made by Prof Kent Woods — the then Chief Executive of the MHRA — when giving evidence to the Select Committee in 2009 (Q182, Ev 65):

From the point of view of evidence, certainly from a regulatory perspective, it is very important evidence that something like ten per cent of the population have used a homeopathic remedy or have gone to a homeopath in the previous 12 months, and that I think is a starting point for deciding what is the public health significance of this phenomenon.

He didn't provide a source for that figure and it's always been contentious. Now, however, we have a more up-to-date figure from the European Social Survey. In their 2014 survey, they asked questions about the use of a number of CAM practices (acupressure, acupuncture, Chinese medicine, chiropractics, herbal treatment, homeopathy, hypnotherapy, massage therapy, osteopathy, physiotherapy, reflexology and spiritual healing) in the previous 12 months in 21 countries. For homeopathy, they found that only 1.3% of people had used it:

Ranking fifth, the UK compares very favourably with the other countries surveyed, and the usage is considerably less than previously claimed. It is also likely that even this is an over-estimate as the survey didn't provide any guidance to participants about what homeopathy was, so it's likely respondents may have included the use of all sorts of herbal or home remedies rather than just homeopathic products.

The same survey gives a picture of the usage of other practices in the UK:

However, for homeopathy on the NHS, it's difficult not to come to the conclusion that it's dying.

30 March 2017

Like all other advertisers, osteopaths have to comply with the ASA's CAP Code and the ASA/CAP publish specific guidance to help them — in addition to the more general guidance on health claims and their substantiation.

However, it seems that some osteopaths thought the CAP Code and guidance required some clarification.

Today, the ASA have published even more detailed guidance for those advertising osteopathy services.

This new document provides that clarity and further restricts the claims they can make about the use of osteopathy with pregnant women, children and babies, particularly non-musculoskeletal conditions such as colic and problems allegedly caused by 'birth trauma'.

A cursory glance at osteopaths' websites will find many such claims. See, for example, the results returned by this simple search for colic: osteopathy clinic site:.uk colic. This is a widespread problem.

Initiative

The new guidance is yet another joint initiative by the ASA and the osteopaths' statutory regulator, the General Osteopathic Council (GOsC) to reign in their registrants and they have written to all 4,800 UK of them informing them of the new guidance and the consequences of failing to comply:

The Osteopathic Practice Standards place a duty on all osteopaths to ensure their advertising complies with the CAP Code (Standard D14). Failing to comply with the Code and associated guidance or rulings could result in GOsC fitness to practise proceedings.

The GOsC and the osteopaths' trade body, the Institute of Osteopathy (IO) will be following this up with further communications and articles in various magazines and the GOsC will also be contacting the various osteopathy training organisations to make sure students are fully aware of their responsibilities. We hope that many students will ask questions of their tutors about why they are being taught something they are not allowed to advertise because of the lack of good evidence. Perhaps the GOsC should be asking themselves the same questions and revist their educational requirements.

Claims

There is a lot of work to be done by osteopaths.

For example, the Osteopathic Centre for Children — part of the Foundation for Paediatric Osteopathy whose tag line is "Paediatric osteopathy is the gold standard in holistic healthcare for children" — state:

Babies

An osteopathic check-up following the birth can help pin-point potential problems and helps to ease the dramatic transition from life inside the womb to the outside world. This initial adjustment involves many bodily systems such as breathing and digestion.

Stresses and strains from the labour or pregnancy can lead to unsettled behaviour and difficulties with feeding, winding, bowel movements and sleeping. Relieving any physical strains with gentle osteopathic treatment can be very helpful and relaxing. The care of the entire family unit is of the utmost concern for an osteopath.

Toddlers

This is a time when children learn to crawl, walk, run and communicate and are keen to explore their environment and to interact socially. It is desirable to monitor the progress of these early developmental milestones and to address the effects of any major physical mishaps or developmental lag to prevent problems developing in future.

In many ways these are mild claims; one osteopath's website more worryingly states:

OSTEOPATHY FOR BABIES AND CHILDREN

In the birthing process babies are subjected to enormous forces during their passage through the birth canal. Small amounts of movement exist in the infant skull to permit the baby’s head to adapt to these forces of labour. However when birth is difficult, unduly slow or fast, or complicated by the need for forceps ventouse or cesarean section delivery, the infant head may not fully recover from this distortion. If the baby is unable to resolve the stressors and strains naturally through breathing and suckling, these pressures with in the skull may lead to problems settling, feeding difficulties, disturbed sleep patterns and recurrent infections. Osteopathic treatment using a variety of gentle non invasive techniques may help improve the function of the musculoskeletal system and aid in the reduction of these symptoms.

During childhood, in addition to any earlier trauma or strains the body has to adapt with the growth and development of the bones and muscles. Postural changes and activity level changes with participation in sports can also produce aches and pains which may be eased with manual therapy. Restrictions in the musculoskeletal system can sometimes cause delay reaching developmental milestones for behaviour, speech and learning and may benefit from osteopathic assessment and treatment.

What parent would not be distressed by such stark warnings and sign their new-born up for immediate (and life-long?) treatment?

ASA guidance

Getting back the the ASA's new guidance on osteopathy, it states:

Following a review by CAP of the Bronfort et al Review in 2010, CAP accepts that osteopaths may claim to help a variety of medical conditions, including:

• generalised aches and pains,
• joint pains including hip and knee pain from osteoarthritis as an adjunct to core OA treatments and exercise
• arthritic pain,
• general, acute & chronic backache, back pain (not arising from injury or accident)
• uncomplicated mechanical neck pain (as opposed to neck pain following injury i.e. whiplash)
• headache arising from the neck (cervicogenic) / migraine prevention
• frozen shoulder/ shoulder and elbow pain/ tennis elbow (lateral epicondylitis) arising from associated musculoskeletal conditions of the back and neck, but not isolated occurrences
• circulatory problems,
• cramp,
• digestion problems,
• joint pains, lumbago,
• sciatica,
• muscle spasms,
• neuralgia,
• fibromyalgia,
• inability to relax,
• rheumatic pain,
• minor sports injuries and tensions.

The Bronfort review was commissioned by the General Chiropractic Council (GCC) in 2009 after I submitted 523 complaints to the GCC about claims being made by chiropractors on their websites — the GCC needed the review because they didn't have a clue about the evidence for the claims their registrants had been making. It was little more than a quick literature review carried out by chiropractors in the US.

Even though Bronfort et al. considered all manner of treatments including reflexology, massage and chiropractic manipulations and not just osteopathic techniques specifically, it did look at various paediatric conditions. In terms of the non-musculoskeletal conditions, Bronfort identified a number of systematic reviews and additional RCTs for these conditions. None was positive for any treatment.

However, it only gave results for the treatment of manual therapies for musculoskeletal conditions for adults and is silent on pregnant women, children and babies, so it's quite a leap to extrapolate to those patient groups from adults.

The National Council for Osteopathic Research (NCOR), funded by osteopaths and the GOsC, is currently undertaking a systematic review of manual therapies in the treatment of children and babies. It'll be interesting to see what they finally publish.

Meanwhile, it seems that the ASA believe that osteopaths are trained to treat pregnant women, children and babies and that they should therefore be allowed to make claims about these patient groups, despite being no good evidence that osteopathy is effective for these conditions. This simply raises the question as to what they are being taught if there is no good evidence it is effective for those groups in the first place.

The question of dose response is not addressed either nor the potential for harm — particularly the many claims that it is 'safe and gentle'.

However, that only applies to musculoskeletal conditions: the new guidance prevents them from directly or indirectly referring to conditions such as colic, growing pains, excessive crying and those allegedly caused by 'birth trauma'. As we have shown above, these are frequent claims.

Regulated

Because they are statutorily regulated, the ASA states osteopaths may: 

…refer to conditions for which medical supervision should be sought if they hold convincing evidence of the efficacy of their treatments (Rules 12.1 and 12.2).

The caveat of holding the necessary standard of evidence is important, but it is not clear to us why statutory regulation should confer any special privileges: whilst the Osteopaths Act 1993 does provide for a means of regulating some aspects, it's primarily a means of protecting the title 'osteopath', ensuring registrants are appropriately insured and that there's a code of conduct and a complaints procedure. Notably, the Act does not prescribe any scope of practice, nor proscribe any treatments. This leaves the public open to being misled.

Principles

The new guidance sets out four principles:

Principle 1: Marketing claims

Claims made on osteopaths’ websites that serve the purpose of encouraging consumers to make a transactional decision (i.e. claims that directly or indirectly invite individuals to consider seeking osteopathic treatment for themselves or someone else must comply with the Advertising Code.

Principle 2: References to treating medical conditions

As healthcare practitioners regulated by statute, osteopaths may offer advice on, diagnosis of and treatment for conditions for which medical supervision should be sought. Those claims should be limited, however, to those for which the ASA or CAP has seen evidence for the efficacy of osteopathy for the particular condition claimed, or for which the advertiser holds suitable substantiation (references to conditions which the ASA or CAP accept osteopathy can help with should be understood on this basis, the ASA acknowledges that new evidence may emerge).² The ASA retains the right to ask to review evidence for the purposes of resolving complaints should it consider the need to do so. Osteopaths should therefore ensure that they have access to substantiation before making such claims, including implied claims to treat a particular condition.

Principle 3: Substantiation for treatment claims

Where the efficacy of osteopathy for treating a particular condition has already been established, treatment claims that do not stray beyond the principles set out in the CAP Guidance will be considered compliant with the Code.

Principle 4: Osteopathy for general and specific patient populations

Osteopaths may make claims to treat general as well as specific patient populations, including pregnant women, children and babies provided they are qualified to do so. Osteopaths may not claim to treat conditions or symptoms presented as specific to these groups (e.g. colic, growing pains, morning sickness) unless the ASA or CAP has seen evidence for the efficacy of osteopathy for the particular condition claimed, or for which the advertiser holds suitable substantiation. Osteopaths may refer to the provision of general health advice to specific patient populations, providing they do not make implied and unsubstantiated treatment claims for conditions.

The principles don't say anything new, but the fourth one is important: osteopaths can claim to treat pregnant women, children and babies, but they can only do so in terms of the conditions listed above and it clearly states the conditions they should not claim to treat.

The guidance also gives some examples of claims that are likely and unlikely to be acceptable. The ASA, quite rightly, steer clear of saying outright what is and isn't acceptable: every claim has to be analysed individually in its proper context. We hope that osteopaths will take note of these carefully and not try to take advantage of any perceived equivocation.

Example claims which are unlikely to be acceptable:

• Osteopaths often work with crying, unsettled babies (Implies colic, which is not supported by evidence)
• Birth is a stressful process for babies
• Babies’ skulls are susceptible to strain or moulding, leading to asymmetrical or flattened head shapes. This usually resolves quickly but can sometimes be retained. Osteopathy can help
• If your baby suffers from excessive crying, sometimes known as colic, osteopathy might help
• Children often complain of growing pains in their muscles and joints; your osteopath can treat these pains
• Osteopathy can help your baby recover from the trauma of birth; I will gently massage your baby’s skull
• If your baby is having difficulty breastfeeding, osteopathy might be able to help
• Osteopathy can also play an important preventative role in the care of a baby, child or teenager and bring the body back to a state of balance in health
• In assessing a newborn baby, an osteopath checks for asymmetry or tension in the pelvis, spine and head, and ensures that a good breathing pattern has been established
• Cranial osteopathy releases stresses and strains in the skull and throughout the body
• Osteopaths can feel involuntary motion and mechanisms within the body
• Cranial osteopathy aims to reduce restrictions in movement

It might take osteopaths a while to clean up their websites.

All in the head

The weakest point of the new guidance is what it permits to be claimed about cranial osteopathy/craniosacral technique. It is a frequent treatment of choice by osteopaths for babies and children. Prof Ernst describes it:

Craniosacral therapy (CST), which, confusingly, is sometimes also called ‘cranial osteopathy’, was invented less than half a century ago by an osteopath. He thought that the spinal fluid is pulsating, the cranial bones are sufficiently movable to enable a therapist feel this pulse from the outside, and that it is possible to influence this process with very gentle manual manipulations which, in turn, would restore health in sick individuals. According to the inventor, the CST-practitioner uses his or her own hands to evaluate the craniosacral system by gently feeling various locations of the body to test for the ease of motion and rhythm of the   fluid pulsing around the brain and spinal cord. Soft-touch techniques are then used to release restrictions in any tissues influencing the craniosacral system.

It's entirely fanciful, of course, but many osteopaths seem to believe it is effective for many childhood conditions and is seen by some as the 'bait and switch' used by some osteopaths to get new customers from a very early age.

But at least now they cannot claim that they can feel these movements nor that they can then manipulate the skull to alleviate anything.

Right direction

This guidance is a great step forward. Osteopaths now have absolute clarity about what they can and cannot claim for pregnant women, children and babies and we hope to see speedy changes to websites.

We also welcome the actions taken by the General Osteopathic Council to ensure their registrants stop misleading the public and we hope they will follow through when they are made aware of non-compliant websites; we also hope they will be pro-active in this and not simply wait around for others to submit complaints.

We now hope the ASA and the General Chiropractic Council will now do the same for chiropractors — it is long overdue and, arguably, a much larger problem. The list of allowed chiropractic claims will be shorter, of course, and the list of unacceptable claims longer. Much longer.

02 December 2016

Little more than a month ago, the Society of Homeopaths (SoH) issued new advertising guidance to all their members. It was far from perfect and, we believe, strays some distance from the guidance laid down by the Advertising Standards Authority (ASA/CAP), but, being generous, at least it was a step in the right direction in curbing the worst excesses of its members' advertising claims.

The ASA should now be checking the websites of SoH members and other homeopaths for compliance and taking appropriate action against those that fall short:

The ultimate sanction is referral by the ASA to the Trading Standards under the Consumer Protection from Unfair Trading Regulations 2008. Trading Standards is the legal backstop for the ASA. What this means is that where the threat or application of our sanctions have failed to achieve compliance, the matter may be formally referred to Trading Standards. Trading Standards will consider cases to determine if there are breaches of relevant legislation and take appropriate action in accordance with its own enforcement policy.

These are serious consequences for any homeopath and it may look like the SoH has faced up to its responsibilities and taken the responsible course of action in trying to help its members comply with the CAP Code and consumer protection legislation.

However, we now know that the SoH is not only supporting an anti-ASA campaign by some of its members, it is also seeking advice on the legality of the ASA's actions with a view to challenging them in the courts.

Legal challenge

Andy Lewis of The Quackometer has highlighted that the Society of Homeopaths (SoH) intend to fight the Advertising Standards Authority (ASA) over the advertising guidance they issued recently.

They're not doing this by providing high quality scientific evidence that substantiate claims for homeopathy made by their members, of course, but by trying to find a legal basis to undermine the ASA's legitimacy as the UK's independent advertising regulator.

They are also supporting a protest against the ASA, encouraging their members to complain to the Competition and Markets Authority and local Trading Standards. They seem to want them to:

…investigate allegations of illegal bias against homeopaths and homeopathy by the Advertising Standards Authority Ltd, in breach of Consumer Protection Regulations.

The 6 RSHoms claim that the ASA has no legal basis for what it is doing and is acting unreasonably in targeting homeopaths.

They are not clear on what consumer protection regulations they believe the ASA has breached, but it's odd that in their previous guidance to their members on complying with the ASA guidance, they stated:

The practical approach of the guidance, combines previous publications published by the Society of Homeopaths, CAP and ASA, and should allow further scope as to what is deemed acceptable, whilst remaining within current legislation, regulation and the Society’s Codes of Ethics. The document lays out a proposal, which has been cross-referenced against the following legislative and national statutory guidance sources. Most of the following are non-homeopathy specific and therefore applicable to all services across all industries:

This admission that the 'legislative and national statutory guidance' are not written specifically to cover errant homeopaths but are laws and regulations that are designed to protect consumers from misleading practices by any and all traders is interesting.

Their arguments against the ASA are well-worn and have been thoroughly refuted. They do try the old 'the ASA is only a limited company' meme and refer to them as the ASA Ltd: perhaps we should refer to the SoH by their own corporate title, The Society of Homeopaths Ltd?

Serious initiative

Anyway, in their guidance to their members, the SoH made several interesting statements with reference to the Professional Standards Authority (PSA) who legitimises them by placing them on their list of Accredited Registers. We submitted a Freedom of Information Act (FOIA) request to the PSA for details of all information held by the PSA relating to the SoH's guidance.

This provided several documents including an email from the SoH to the Director of Standards and Policy at the PSA, dated 07 December 2015:

Sorry to chase you but I wanted to update you on a serious initiative by ASA/CAP. See attached letter [download here].

In short, with no notice or consultation at all, they want to impose guidelines on us, send them out inside a month and then chase all our members to make sure they have complied within a month! You will not be surprised to hear that we have refused to co-operate but we have said that, if they pause the process, we are more than happy to meet with them and see if we can work out a way forward that ensures our members are compliant to reasonable guidelines. We need to be working with them in the long run, rather than working against them.

As far as I am aware, no other accredited register has been targeted. I am guessing they will be in time!

The belligerent nature of their language puts into context the SoH's latest pronouncement about taking legal action against the ASA and the assumption of being singled out by the ASA for special treatment speaks volumes. No doubt such a line would play nicely to their vexed members.

That the SoH refused to even cooperate with the ASA is extraordinary (even if they did recognise they will have to cooperate eventually) and we sincerely hope it raised more than a few eyebrows at the PSA.

The PSA themselves state:

Standard 8 requires registers to set standards of business practice, including advertising (and to comply with the Advertising Standards Authority’s requirements).

The PSA's 2015 decision to accredit the SoH gave the following instruction to the SoH:

The Society must replace the section of its Code of Ethics and Practice relating to Advertising and Media which states ‘Examples of Codes the Society may also take account of are the relevant clauses of The UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing (CAP Code), and the current guidelines of the Society’ with ‘will take into account’. This action to be completed within three months.

The PSA's views of the necessity of complying with the ASA's rules could not be clearer, but here we have am Accredited Register not only wanting special, more 'reasonable' — presumably less stringent — privileges but actively seeking to take legal action against them.

Five years notice

But why this talk of 'no notice or consultation'? The ASA's remit was extended to cover traders' websites on 01 March 2011. The ASA issued clear guidance specifically for homeopaths in September 2011. The ASA's adjudication against the SoH themselves was published on 03 July 2013. There can surely be no excuse for the SoH not to be aware of their obligations under the CAP Code yet they and their members have already been given five years to comply. What have they not complied already? How much more time do they need?

It does seem to us that the SoH were looking to the PSA for some protection from those baddies at the ASA. However, other than an informal discussion between them on 12 January, no more appears to have been said. Hopefully the PSA will have reminded the SoH at that meeting of their responsibilities under the Accredited Register scheme.

But it seems the SoH were successful to some extent in delaying the ASA's action: their letter finally went out to homeopaths up and down the country in September this year and they were given a full five weeks in which to get their websites in order — five years eight months after the rules came into force for websites.

Hearsay

But returning to the SoH's guidance, we felt that what they said about testimonials was particularly interesting:

Testimonials

When referring to testimonials, it is wise to encourage people to seek independent medical advice and stay in close contact with their mainstream healthcare professionals. This supports an open dialogue, choice and informed, integrated care. The below was agreed by the Preliminary Investigation Panel, the Professional Standards Authority have also seen this statement, and appear happy with its use.

Declaring that the PSA 'appear happy' with their interpretation of the ASA's guidance on testimonials seemed rather odd and informal language to us: did the PSA fully agree with the statement or did they not? Did they even have a view on whether such a disclaimer would adequately protect them from the ASA?

We asked the PSA:

1. What communication has there been with the SoH on this?

The testimonials were discussed as part of last year’s reaccreditation process, in particular the annual review report, we sent all of the information except the information we consider exempt to you in November 2015. There have been no further discussions about the testimonials since this date.

2. What does the statement that you 'appear happy' with the use of these statements mean?

It is our understanding that this relates to the statement in the published panel decision in 2015. The decision reflects the fact that the panel was made aware of the above but made no specific comment for or against it.

3. Can you confirm that you told the SoH that the use of these statements by their registrants in their advertising was acceptable to you?

We have made no specific comment about this matter beyond what is said in the 2015 decision. This is because we consider this to be a matter for the ASA.

The 2015 decision referred to is no longer on the PSA's website, but in relation to the ASA and testimonials, it says:

The Society [of Homeopaths] also found guidelines relating to testimonials were restrictive and could prevent registrants from providing sufficient information for service users to make informed decisions. The Panel noted the Society has provided a disclaimer for registrants’ websites to make clear testimonials are not intended to make any false claims about homeopathy.

It's not at all clear to us how the SoH interpreted that as saying that the PSA 'appear happy' with the SoH's disclaimer, but now that the PSA have made it clear they believe it to be a matter not for them but for the ASA, we sincerely hope the SoH will update their guidance to clarify the PSA's position on this and update their guidance to bring it in line with the ASA's.

The SoH's advertising guidance does go on to say:

Please note: Any claims made within a testimonial are subject to the CAP Code. Therefore, if a testimonial makes an efficacy claim, the author’s permission should be sought to edit out the relevant parts.

Although this is an important part in the ASA's guidance on testimonials and endorsements, it is but one part of it. Overall, the SoH could have saved themselves a lot of bother by simply referring their members directly to the ASA's own comprehensive and clearly written guidance rather than regurgitating it and interpreting it, changing it in the process, inadvertently or otherwise.

Trade directories

As well as writing to thousands of homeopaths, we have been made aware that the ASA have also contacted at least one trade directory, informing them of the requirements to comply with the CAP Code. 

Therapy Directory lists some 3,855 practitioners and premises in 34 different categories, including homeopaths. We were sent a copy of the text of an email from them, sent originally to a homeopath, explaining their decision to comply with the ASA's guidance:

I can appreciate how you and other Homeopaths currently feel and I hope that this email will help your understanding as to why we have made these changes.

Because this is now a legal requirement for advertising, as a marketing platform, we must abide by it. CAP were the ones that contacted us about the changes which is why we have actioned it.

I can see that you have already complied [sic] a detailed document raising your concerns, but please also have a look here: http://www.homeopathy-soh.org/images/ASASept2016/ASA-Guidance-6.pdf [the SoH's advertising guidance] as this may prove helpful for you when addressing this with the ASA / CAP. I would recommend contacting CAP as they are the ones that have implemented these changes and are therefore the ones to speak with.

Unfortunately, because we are a marketing platform and not therapists ourselves, as mentioned before we must adhere to these changes and won't be challenging this with either the ASA or CAP.

Please do keep us updated, I believe that you will receive a great amount of support from other Homeopaths that are currently experiencing the same.

It's good to see the ASA taking such a comprehensive approach to cleaning up this sector and Therapy Directory's responsible action to comply with the ASA's rules.

We hope all homeopaths, their trade bodies and other trade directories follow this responsible lead.

Crossroads

But to return to the SoH in particular: is there really a conflict between representing your members best interests and complying with the rules, regulations and laws they are supposed to?

That depends on what you believe is in your members' best interests. The SoH seemed to have taken a responsible approach to persuade its members to comply, but the other face they now show wants to challenge the ASA in the courts.

It'll be interesting to see how far they get, but it would be perverse if it was believed that continuing to defy the advertising regulator and face possible conviction under consumer protection regulations was in the best interests of any homeopath or of the SoH itself.

The Society of Homeopaths Ltd are at a crossroads: they need to grapple with the choice they face and decide whether they will go down the path of challenging the ASA or finally face up to their responsibilities as a supposed professional regulator, overseen by the Professional Standards Authority.

This will also be a challenge for the PSA: how they deal with a wayward SoH will be a test of their willingness and ability to properly oversee their Accredited Registers and properly protect the public.

22 November 2016

In March 2011, our very first campaign was against the misleading advertising claims made by homeopaths on their websites. That was six years ago, and we gave the Advertising Standards Authority a huge headache: how to persuade homeopaths to abide by the same rules all advertisers have to abide by.

Without those advertising rules (in the form of the CAP Code), advertisers would have free rein to make whatever claims they wanted; it would be a wild-west for all sorts of cowboys and quacks and one where the poor consumer would suffer.

Homeopaths have featured in the ASA's list of adjudications and informally resolved cases over the years, but the ASA have recently preferred to let their Compliance Team deal with homeopathy advertisers because they had already extensively reviewed the evidence — notably through complaints about the Society of Homeopaths and homeopath Steve Scrutton, Media & Communications person at the Alliance of Registered Homeopaths — and had an established position on it. Read more about these adjudications in: Landmark decisions for homeopaths.

A few advertisers have been somewhat recalcitrant, believing they could face down the ASA. Some even seemed to think the ASA could be ignored, but many have found that is not a sensible course of action and one that's not good for their business.  However, many advertisers of complementary and alternative therapies appear in the ASA's list of Non-compliant online advertisers and others have been referred to Trading Standards (TS).

Trading Standards have now successfully prosecuted 'Electronic Healing' (a provider of complementary and alternative therapies and devices) who had been referred to them by the ASA. TS have also had numerous websites taken down: they cannot be ignored.

We have no doubt that many homeopaths were just not aware of the advertising rules or the need to abide by them. Many will now comply because they understand the need for rules to protect consumers and are responsible traders who want to stay on the right side of the law. But not all.

Action

Today, the ASA announced that they have written to homeopaths across the UK to remind them of the rules that govern what they can and can’t say in their marketing materials, including on their websites. This included their previous Guidance for Advertisers of Homeopathic Services and FAQs about advertising regulation and the sanctions the ASA can impose.

It also builds on the advertising guidance published by the Society of Homeopaths (SoH) a few days ago, which had been reviewed by the ASA. You may remember that the SoH themselves fell foul of the ASA three years ago and an adjudication against numerous claims they made on Twitter and on their website found they had breached the CAP Code on multiple counts. Read more about the adjudication in: Landmark decisions for homeopaths.

While we generally welcome the guidance from the SoH, we believe this guidance is incorrect and misleading in places and goes beyond what we believe the CAP Code allows, but at least it's a step in the right direction. Whether they ensure their members now comply with the CAP Code remains to be seen.

With the ASA's letter to thousands of homeopaths, their published guidance on compliance and the SoH's letter to their members, there really is now no excuse whatsoever for homeopaths to continue to make misleading claims.

The ASA has given them a deadline of 03 November 2016 to change their websites to become compliant:

After the expiration of this period, we will carry out extensive monitoring spot checks. Homeopathy practices that have failed to comply will be contacted again. After this time, we will consider the application of appropriate sanctions.

Campaigning continues

This is the culmination of six years of campaigning for us — our initial campaign and the occasional prodding of the ASA and submitting the odd strategic complaint. Although there is much more still to do, we've done our bit to highlight the many issues with homeopathy advertising: it is now up to homeopaths to take the responsible action they know they must.

Perhaps the Society of Homeopaths could set a good example to its members by having a thorough review of its own website?

29 September 2016

We've previously looked at how homeopathy in the English NHS has plummeted 95% in the last two decades. We now focus on what's been happening is Scotland.

The NHS in Scotland is separate from the NHS in England and they collate their prescription data separately, provided by the Information Services Division, a division of National Services Scotland, part of NHS Scotland. (Wales NHS and Health and Social Care in Northern Ireland are also separate and we may look at these in the future.)

Their Prescription Cost Analysis (PCA) data since 2001 (shortly after devolution in 1999) are available on one handy webpage, making them easier to find, with each spreadsheet covering the financial year from 01 April up to 31 March of the year given in the filename. The latest spreadsheet, PCA_2016.xlsx, therefore covers 01 April 2015 to 31 March 2016. Note that for consistency with the data for England, we have attributed the Scottish data for the year in the filename to the previous year in the charts below, ie the 2015/2016 data are attributed with 2015 to match the way the data for England have been attributed.

Tab 3 - BNF sub-section gives the data we need. As with the NHS Digital (the re-branded name for the HSCIC) data for England, the data relate to the NHS prescriptions dispensed in community pharmacies and by Dispensing Doctors in Scotland.

The prescription data are listed by BNF chapter, section and sub-section and the one for homeopathic (homoeopathic before 2013) preparations is 19.02.03. The data provided include the number of dispensed items, the Gross Ingredient Cost and the cost per item. Note that the costs given in the English data are called Net Ingredient Costs (NIC) but they are directly comparable: the Publication Report explains:

Comparability

The main measures of drug ingredient cost and volumes of items dispensed in the community are comparable across the UK countries. However it should be noted that the gross ingredient cost (GIC) within Scotland is equivalent to the net ingredient cost (NIC) in England, i.e. the reimbursement cost of drugs before any pharmacy discounts are applied.

Collating these data from each of the years gives the following:

A spreadsheet with these data can be downloaded here.

Anomaly

But why the small rise in prescriptions in 2012 and 2013? Was there a resurgence in public demand for homeopathy? Perhaps more GPs became convinced of its curative power? Maybe some new, compelling evidence for homeopathy hit the headlines?

Probably not. The answer is more prosaic: the closure of the pharmacy at the Glasgow Homeopathic Hospital (re-branded the Centre for Integrative Care (CIC) recently) in 2011 will have caused a small increase in the number of prescriptions dispensed in community pharmacies.

When Andy Lewis revealed the closure of the pharmacy in November 2011, he said:

The ratchet on NHS homeopathy continues to turn. It would appear that the homeopathic pharmacy at the Glasgow Homeopathy Hospital has been closed.

A note to local GPs is reminding them that they have no obligation to fill the hole left by this closure by prescribing homeopathy if patients ask for it.

The Glasgow Local Medical Committee notes that there has been a sudden surge in requests from patients to prescribe homeopathic sugar pills after they have been unable to get them at the hospital.

The prescription numbers before 2011 don't include those dispensed at the GHH/CIC, but those after 2011 are inflated by the ones GHH/CIC patients have had go to their local community pharmacy to have dispensed.

But note that this blip is more than wiped out by the falls in 2014 and 2015, leaving an overall 62% drop in the past ten years.

The drop isn't as great as the 95% in England, but it is still very significant. Referrals to the GHH/CIC have been stopped by various Scottish Health Boards, putting pressure on them — it would seem unlikely that the long-term downward trend will be reversed.

Pressure

The number of patients at the GHH/CIC has been falling in recent years. Data from NHS Greater Glasgow and Clyde (GGC) — the health board that runs the GHH/CIC — show significant drops in the number of new inpatients from areas outside of GGCin recent years but that has been partially offset by an increase in numbers of referrals from within the GGC area. Overall, the number has still fallen 9% in the past four years to 332 in 2015 — about one new patient a day.

Similarly, falls in the number of new outpatients referred from areas outside GGC has been compensated by an increase in local referrals, leaving the number hovering around the 1,000 mark each year — in the order of three new patients a day. They also had 4,723 return appointments in 2015.

The hospital is currently facing the closure by GGC of its seven inpatient beds (which had previously been cut in 2010 from 15 beds Monday to Sunday to seven beds Monday afternoon to Friday morning), saving £190,000, putting it under further pressure.

In their proposal to close the seven inpatient beds, they said:

The proposal to close the CIC beds is based on the fact that:

• The Unit has reduced its inpatient service in recent years from a 15-bedded seven-day unit to only 7 beds, open 4 nights a week.
• The Centre has been very successful in developing an ambulatory model of care and all services are now available on that basis.
• Inpatient capacity is now underutilised delivering only 332 episodes of care each year. This will be further reduced by the continuing impact of decisions by other Boards to withdraw from the service, only 224 in patient episodes are provided for NHS GG and C residents.
• Inpatients account for only 5.2% of patient contacts for GGC residents. The majority of service delivery is already delivered in an outpatient setting.

Supporters of the GHH/CIC are campaigning to prevent its closure, including a Public Petition to the Scottish Parliament: PE01568: Funding, access and promotion of the NHS Centre for Integrative Care. The committee has been considering this for well over a year and seem to be making little progress; instead they seem keen to show their inability to understand scientific evidence.

If the closure is agreed by the GGC Board, this makes the GHH/CIC even less viable and it's not clear how long the hospital can last — its future is on a shoogly peg.

England and Scotland

As a reminder, the charts for England:

Combining these (from 2001 to 2015) give the following for England and Scotland together:

Homeopathy has been diluted to just 13% of its former self in the past 14 years.

Out of proportion

But looking at the data in more detail reveals something that looks odd: last year, there were 60% more prescriptions in total in Scotland than in England. The figures equate to 2.62 prescriptions per 1,000 population in Scotland but only 0.16 per 1,000 in England. But this has changed over the years: in 2001, it was the other way round with 2.7 times more prescriptions in England than in Scotland.

If it was simply down to population, you'd expect there to be more than ten times the number in England compared to Scotland.

Why is this not the case and why has it changed like this over the last 14 years?

One possible explanation might be to do with the number of NHS homeopathic 'hospitals' and the legitimacy they lend to homeopathy in general: there has only been the one in Scotland but there have been four in England in recent times: London, Bristol, Liverpool and Tunbridge Wells, plus a number of satellite clinics. Now, however, only the Royal London Hospital for Integrated Medicine remains, with the ones in both Liverpool and Bristol replaced by contracted private companies rather than being part of the NHS. The one in Tunbridge Wells closed in 2008. So, in its heyday around the turn of the century, Scotland was served by one but England was only served by four — proportionately far fewer considering the population.

So, with the only the London hospital now remaining — even though it no longer has a dedicated homeopathy service — the decline of prescriptions in England was perhaps inevitable, following the decline in the number of hospitals.

Good news

For those who do not believe public money should be spent on homeopathy, these figures will be welcome, but perhaps not so much for those in the homeopathy business as the false imprimatur given to homeopathy by the State plummets.

29 August 2016

New figures released today show that homeopathy on the English NHS has fallen to a new low. The number of NHS prescriptions for homeopathy in England, fulfilled in community pharmacies, dropped by a further 13% in 2015 from the previous year and is 95% down from its peak nearly 20 years ago.

The data are compiled by the Health and Social Care Information Centre (HSCIC) — the official source of data for the NHS — and published as their Prescription Cost Analysis (PCA) data set.*

The new figures for 2015 show that there were just 8,894 prescriptions, down from 10,238 in 2014. The total cost of these prescriptions has dropped to £94,313, the first time it has been below £100,000.

The complete data for these charts are (all these figures can be verified from the original HSCIC data):

This follows on from other recent blows to NHS homeopathy: the closure of the homeopathy clinic at the South Bristol Community Hospital in Bristol, the reviews by both Liverpool CCG and Wirral CCG on ending the funding of homeopathy via the Liverpool Medical Homeopathy Service and other successfully completed reviews.

And the forthcoming Department of Health review of the blacklisting of homeopathy could mean CCGs are no longer able to prescribe it — not that many do now anyway.

Dilution by dilution, succussion by succussion, sugar pill by sugar pill, homeopathy is slowly but surely being removed from the NHS.

This will not be welcomed by homeopaths who businesses rely on the (undeserved and unearned) legitimacy that being provided on the NHS lends to homeopathy, but it's the inevitable result of the their own failure to provide robust evidence of its efficacy.

Switzerland legitimises homeopathy

In other news, however, it was announced by the international service of the Swiss Broadcasting Corporation, SwissInfo.ch, as:

Swiss to recognise homeopathy as legitimate medicine

…but it would have been more accurate to say:

Swiss to recognise homeopathy as if it were legitimate medicine

That's because:

…the interior ministry said it had come to the conclusion that it was “impossible to provide such proof for these disciplines in their entirety”.

So, it's not that the Swiss authorities had come across good evidence that homeopathy (and the other treatments covered) were, indeed, effective; more that they gave in and decided to reimburse them anyway, despite the lack of evidence.

The saga of homeopathy in Switzerland goes back many years (see That ‘neutral’ Swiss homeopathy report). Full and permanent inclusion in the Swiss state health reimbursement scheme from 2017 onwards was supposed to be contingent on being provided with evidence of "efficacy, cost-effectiveness and suitability" by 2015. Not surprisingly, homeopaths seem to have failed at that and the Swiss Government have completely ignored the findings of the comprehensive report by the Australian National Health and Medical Research Council that concluded:

Based on the assessment of the evidence of effectiveness of homeopathy, NHMRC concludes that there are no health conditions for which there is reliable evidence that homeopathy is effective. Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.

It is therefore perverse that the Swiss Government should appear to bend over backwards to ignore the evidence and agree to pay homeopaths for dispensing their magic sugar pellets.

But it may not be as smooth a ride as the homeopaths might like. Reimbursement will only take place for treatments administered by certified medical doctors. Additionally, according to the official announcement in Komplementärmedizin soll anderen Fachrichtungen gleichgestellt werden, some criteria apply concerning tradition of usage and research, scientific evidence and medical experience and further education. Also, some treatments that are seen as critical are to be examined and potentially excluded from the reimbursement. It's not at all clear exactly what this will mean for the homeopaths, but this may not be the full endorsement from the Swiss Government they would like to believe.

Let's beware

This Sunday is the anniversary of the birth of the inventor of homeopathy, Samuel Hahnemann, heralding the start of World Homeopathy Awareness Week.

So as homeopathy on the NHS is in what must surely be its death throes, what better time to help others be aware of homeopathy?

Help spread the good news about homeopathy by sharing this newsletter and the following resources and further reading:

Discover Homeopathy

How does homeopathy work?

Homeopathy Awareness Week

Skeptic successes in homeopathy by Jo Brodie

NHS Homeopathy Legal Challenge by the Good Thinking Society

NHS Homeopathy Spending by the Good Thinking Society

Should Homeopathic Remedies Be Blacklisted On The NHS?&nbspby the Good Thinking Society

Follow us on Twitter and re-Tweet our Tweets on homeopathy throughout World Homeopathy Awareness Week.

Notes

* For details of how to extract the data on homeopathy from the (very large) HSCIC data set, see:  An idiot’s guide to understanding NHS homeopathy prescription data

07 April 2016

The last year or so has not been good for homeopathy. The comprehensive Australian National Health and Medical Research Council concluded that "there are no health conditions for which there is reliable evidence that homeopathy is effective." The FDA and the FTC in the US are considering their positions on the regulation and advertising of homeopathic products and will hopefully clamp down on the worst excesses of misleading claims made there. In the UK, homeopathy continues its downward spiral, it's being challenged in Liverpool and the Department of Health will consult next year of the complete blacklisting of homeopathy. 2016 is going to be a very interesting year for homeopathy.

Last August, we published details of our complaints against Nelsons Homeopathic Pharmacy. We're still waiting for the General Pharmaceutical Council to complete their investigation, but the medicines regulator, the MHRA, has already published their decision. In that newsletter, we said we were waiting for a further response from the MHRA. Although we're still waiting for a formal reply from them, the essence of what we were waiting for has just been published by them in yet another complaint about homeopathic products.

Schuessler Salts

Wilhelm Heinrich Schüßler (Schuessler) was a German medical doctor and naturopath. He concocted twelve biochemic 'cell salts' or 'tissue salts' (as he called them), intended to redress percieved bodily deficiencies in one mineral or another. Frequently referred to as 'microdoses' these are accepted as homeopathic by some homeopaths and rejected by others. When I asked one manufacturer, I was told:

Tissue Salts are not homeopathic but are homeopathically prepared micro dose minerals. Dr. Schuessler believed that it was most effective to follow the principles of homeopathy in their preparation – 1 part mineral to 9 parts lactose – mortar and pestle for 20 minutes bringing it up to a 1X and so on.  They can be touched by hand and work differently in the body navigating all that you eat and ingest where they need to be.  They are not as sensitive as homeopathics.  They can be taken alongside food, coffee etc.

And:

Tissue Salts are not Homeopathics but are micro dose minerals that follow the similar method used in preparation - they will not interfere with homeopathic Nat Mur - it is important to note that Minerals are not homeopathic, they are biochemic. They do not follow the rule of similarity as many consider but are prepared in the homeopathic manner in order to provide bioavailability. The system needs minerals in order to function in these minute doses. They are absorbed through the mucosa that enables them direct entry to the blood stream and the availability to the cells.

At least that's clear…

Whatever the different factions within homeopathy believe, Schuessler Salts are frequently labelled and sold as being homeopathic. But are they as ineffective as homeopathy? The Commissioner for Public Health in Australia looked into one of these salts and declared:

THE following report is issued under section 210 of the Health Act, 1911-1944:—It is claimed that the above "remedy" [Dr. Schuessler's Cell Salts, Kali Phos. 3X] is "indicated in loss of mental power, brain fag, paralysis of any part, nervous headaches, neuralgic pains, general disability and exhaustion and sleeplessness from nervous disorders." The "remedy" has been analysed and been found to contain potassium dihydrogen phosphate and lactose. The actual quantity of potassium dihydrogen phosphate in the "adult dose" is so minute that over 9,000 tablets would be necessary to give the minimum medicinal dose of this drug. Lactose is a sugar which is of no value in the treatment of any of the above-mentioned maladies. Dr. Schuessler's Cell Salts can therefore have no curative value. They will bring about no improvement in any of the illnesses for which they are said to be indicated. Any expenditure on the purchase of these salts will be money wasted.
— C. E. COOK, Commissioner of Public Health

That was in 1946.

One of the main brands of these products is an Australian company, Martin & Pleasance, but there are others, including the New Era range (once owned by the pharmaceutical giant, Merck through their Seven Seas brand, but now owned by the Italian company, Olimed Ltd, sold in the UK by Power Health Products Limited).

Nelsons

It was the Martin & Pleasance products we found being advertised on Nelson's website. Because they do not have a licence under the National Rules Scheme, an authorisation under the Homeopathic Rules Scheme nor even a (defunct) Product Licence of Right, we questioned whether these could be unlicensed medicines. The significance is that if the MHRA ruled they were unlicensed medicines, it would be a breach of the Human Medicines Regulations 2012 (HMR 2012) to advertise, supply or sell them.

Today, the MHRA published their decision on a complaint about the advertising of these or similar products by Homeopathy Express, Nutricentre and Health Stuff. Although these were not our complaints, the MHRA have now published what they told us previously about Schuessler products and what we've been trying to get them to state publicly:

MHRA guidance: Tissue Salts/Schuessler Salts are considered to be medicinal products if any of the following appear in promotional material:

• the terms ‘homeopathic remedy’, and/or ‘homeopathy’ and/or ‘homeopathically prepared’
• a numerical value for the potency eg 6X and/or the word ‘potency’ itself
• indications for use in a medical condition

All other cases will be reviewed on a case-by-case basis.

So, it's perfectly OK to advertise these products as long as it is not claimed that they are in any way homeopathic, they do not have a homeopathic 'potency' and they have no therapeutic indications. If they comply with all of these restrictions, they will not be medicines, but will simply be food supplements and have to comply with food regulations. This is essentially the same as when Bach Flower products were declared to be foods, not medicines nearly a year ago.

The standard labelling of these products (such as the one in the photograph) stated they were '6X' 'potency' and the mere mention of this is sufficient to bring it within the MHRA's definition of a homeopathic medicine. This is a direct consequence of the EU Directives and the HMR 2012: homeopathic 'medicines' are regulated and anything that is presented as being homeopathic is a medicine and has to comply with these rules.

If they are not presented in any way as homeopathic, then they are just foods, not medicines.

Quite rightly, the MHRA will review each product individually, but we think it's clear that this ruling applies to the following:

• Schuessler Tissue Salts
• Dr Reckeweg
• New Era
• Swanson
• Homeoforce

There may be others and if you spot any on sale in the UK that appear to be contravening the MHRA's new guidance, please let us know and consider submitting a complaint to the MHRA about them.

The aftermath

Before our complaint against Nelsons, their website said:

That page now says:

There is now no mention that these products are homeopathic.

But what about the websites of the three sellers mentioned in the MHRA's decision?

Homeopathy Express

This is advertising New Era Calc Sulph (No.3) Tissue Salts and Brittle Nails & Falling Hair (Comb - K), but both are currently not available and another page says they have been discontinued. It looks like they also used to sell the Dr Reckeweg brand of tissue salts but they have been removed.

Health Stuff

Whatever Schuessler/cell/tissue salt products they sold, they are no longer advertised on their website.

Nutricentre

Thirteen of the sixteen Schuessler products they advertise are currently out of stock.

For two of the three that are available, the description shows:

Combination J:

Congestion by Schuessler Tissue Salts. Kali Mur Nat Mur & Ferr Phos For relief from symptoms associated with Chest congestion Coughs Colds Available in tablets. Always read the label use only as directed. If symptoms persist consult your healthcare professional. For over 150...

Combination H:

Schuessler Combination H Tissue Salt is a complete natural formula for hayfever and allied conditions with mag phos nat mur and silica. Hayfever is an allergic condition of the mucous membranes of the nose eyes and upper respiratory tract and is common during spring when sensitivity to pollen is severe but it is very treatable by combination H particularly if treatment is started from six weeks before the expected onset of normal symptoms.

For Calc Fluor No 1, although out of stock, the product page states:

The cell salt Calcium fluoride is primarily a salt of the connective tissue

Also the bones and parts of the skin and blood vessels belong to the connective which is why Calcium fluoride can be used for all problems of these tissues

…

Ingredients: Calcium Fluoride 6X Lactose Monohydrate Calcium Hydrogen Phosphate Magnesium Stearate

Many of the others have similar information.

These would appear to be therapeutic indications and some refer to the potency as 6X, possibly contravening the MHRA's guidance so we'll be bringing these to their attention and hope that they will be corrected before the products return to stock.

This is another step forward for informed consumer choice, but another blow for homeopathy. Gradually, sellers of homeopathy and homeopathy products are being held to account. Homeopathy is taking a beating, perhaps fatally wounded.

Addendum

I have just come across this advert for New Era Tissue-Cell Salts in the February 1951 issue of the homeopathy magazine, Heal Thyself:

It's a pity the Advertising Standards Authority wasn't around then.

30 December 2015

Not that long ago there were five homeopathic hospitals in the UK: London, Tunbridge Wells, Bristol, Liverpool and Glasgow. The Tunbridge Wells and Liverpool hospitals have since closed and the pharmacy at the Glasgow one is no more.

As for the Bristol hospital, it started out in its own building near the centre of Bristol (Cotham Hill), then it became a small clinic in the new South Bristol Community Hospital. Earlier this month, just three years later, this too closed to be replaced by a private clinic, the Portland Centre for Integrative Medicine, that is no longer part of the NHS but that is now just contracted to provide homeopathy services to University Hospitals Bristol. It's situated in Litfield House Medical Centre, which offers private consulting rooms, some six miles from the hospital.

And then there were two

Today, there remains only the Royal London Hospital for Integrated Medicine (the re-named Royal London Homeopathic Hospital) and the Glasgow Homeopathic Hospital (aka the Centre for Integrated Care, as they like to call it).

NHS Lanarkshire was the latest of the Scottish health boards to end funding of all treatments at the Glasgow Homeopathic Hospital, and, in August, one of it's previous patients from Lothian lost her judicial review at the Court of Session of the earlier decision by NHS Lothian, finally putting an end to the homeopathy supporters' protracted battle.

But now we know that even the jewel in the homeopaths' crown, the RLHIM, no longer has a homeopathy service.

We've known this for some time as it was admitted by them in their response to a Freedom of Information Act request last year and this service has not been mentioned on their website for some time. It is now public thanks to someone else's FOIA request. All they provide now are:

• Acupuncture Services
• Adult Allergy Service
• Allergy Service
• Chronic Fatigue Service
• Children’s Service
• Complementary Cancer Care Service
• Fibromyalgia Syndrome Service
• General Medicine Service
• Hypnosis Service
• Insomnia Service
• Irritable Bowel Syndrome Service
• Musculoskeletal Medicine Service
• Nutrition and Dietetics
• Podiatry Service
• Rheumatology Service
• Skin Service
• Psychological Services
• Weight Loss Service
• Women’s Service

But no homeopathy service. For their flagship hospital, closing that down must have been a bitter sugar pill to swallow.

Even though homeopathy isn't mentioned they still provide it under the guise of other services. The list of services doesn't match those listed on their website (and there are some interesting differences), but some do include homeopathy:

• Complementary cancer care service
• Podiatry & Chiropody - The Marigold Clinic
• Skin Clinic

Of course, we've won several Advertising Standards Authority rulings and informally resolved cases against the RLHIM over claims they made on their website and in leaflets. In Homeopathy clinic toes the line, we briefly mentioned Prof David Colquhoun's blog post: Conflicts of interest at the Homeopathic Hospital. It's good to see that the RLHIM has since made this clearer:

And in overall terms, we also already know that the number of prescriptions for homeopathy products supplied by community pharmacies in England has fallen by 94% in the past 17 years.

We also know that very few Clinical Commissioning Groups fund homeopathy.

How much longer will NHS homeopathy survive this downward spiral?

Ainsworths

After Nelsons were reprimanded in August (as a result of our complaint), another homeopathy manufacturer was today admonished by the medicines regulator, the MHRA.

As part of MHRA’s regular review of advertising, we reviewed the Ainsworths website. Some unlicensed homeopathic remedies had the name of a commonly recognised disease or medicine. We were concerned that this could be seen as a claim to treat or prevent that disease. We were also concerned that remedy kits containing unlicensed remedies were being promoted for sale in the UK.

Ainsworths agreed to remove the name of the disease and the medicine names from unlicensed remedies on their price list and amend the web pages with remedy kits.

It's encouraging to see that the MHRA instigated this themselves rather then waiting for a complaint from a member of the public or a pharmacist, but it's disappointing that they have not given details of what products they were concerned about.

In terms of the kits, they have been in trouble before, so it's disappointing to see them being pulled up again, apparently for exactly the same breach of the medicines regulations.

Note that the decision is dated 10 June, yet the decision was only published today. It's therefore even more disappointing and concerning to see Ainsworths still advertising unlicensed remedies such as these:

We sincerely hope that Ainsworths will comply with the MHRA's instructions to remove all products with the name of a commonly recognised disease or medicine, and — in the interests of not misleading the public — products that have names very similar to commonly recognised diseases or medicines. We're sure Ainsworths would not want to mislead consumers but we hope the MHRA will continue to monitor their website and take further action as necessary to protect consumers.

Photo credit

The defunct Tunbridge Wells Homeopathic Hospital by Tannice Hemming.

22 October 2015

As usual, the MHRA give few details of the complaint, their investigation, what they found or what they decided:

Even though there is a link that purports to give more information, this simply links to the page where this decision is listed along with others for July. They even fail to give the proper name for the trader, Nelsons Homeopathic Pharmacy, or give the urls of the two websites involved: http://www.nelsonsnaturalworld.com and http://www.nelsonspharmacy.com/.

It's not clear to us why these decision notices are so void of any details that would help consumers: the Advertising Standards Authority (ASA) by contrast, when they publish an adjudication, give full details of the complaint, their investigation, the advertiser's response, their decision and the sanctions applied. For example see this ASA adjudication against another homeopathy manufacturer, Ainsworths.

The issues we highlighted to the MHRA were mostly about the advertising of homeopathic products that was not within the terms of the authorisation or registration for those products. For example, their Arnicare Arnica 6C product stated:

Indications: For the symptomatic relief of sprains, muscle aches, bruising and swelling after contusions.

However, this is a Homeopathic Rules (HR) scheme product and its registration does not permit therapeutic indications. Instead, all advertising for HR products must simply contain the text:

A homeopathic medicinal product without approved therapeutic indications.

It's a moot point whether the general public understands this to mean that there is not a jot of good evidence that these products have any therapeutic effects whatsoever, a point raised by the House of Commons Science and Technology Select Committee in their Evidence Check on homeopathy.

Another page advertising their Aconite 30C National Rules (NR) scheme product contained the following instructions:

They can even be dissolved in warm water if preferred.

However, the Public Assessment Report for ths product gives the posology and method of administration as:

Adults and children: Take 2 pillules every 2 hours for the first 6 doses, then 4 times daily until symptoms improve for up to a maximum of 7 days.

Pillules should either be chewed or placed under the tongue until dissolved.

Although it makes not the slightest difference to the 'effectiveness' of the homeopathic product, there is no mention of dissolving in warm water as a permitted method of administration.

The other issues covered by this decision were similar to these and we suspect they were simply oversights by Nelsons — they have now corrected them.

In total we identified eight issues with the advertising of their products on their websites, including the ones above. When the MHRA told us of their decision, we queried a couple of points and we're waiting for a further response from them. We'll let you know when these have been satisfactorily resolved.

However, the issues the MHRA have dealt with were just part of our larger complaint to both the MHRA and the General Pharmaceutical Council (GPhC), the statutory regulator for pharmacies and pharmacists. Once the GPhC have completed their investigations into all the other issues we raised, we'll let you know.

Meantime, we've added this MHRA decision to our growing list of published results.

14 August 2015

The April 2015 issue of What Doctors Don’t Tell You carried an advert by Life Long Products for their 'Stem Cell Therapy (SE2)' product that claimed it could improve the body's ability to:

• MAINTAIN optimal health
• BOOST your immune system
• PROTECT your nervous system

We know that boosting the immune system is a common claim made by advertisers of alternative therapies and supplements and something they might like us all to think is good for us. In fact, it turns out that boosting the immune system is not such a good idea at all.

The testimonial in the advert could also give the impression that arthritis sufferers using this product can stop using painkillers.

As has been noted elsewhere, there is frequently a connection between adverts and articles, and this one boasts:

StemTech as featured in WDDTY Jan & March Issues - by Vet Paul Boland

Can stem cell therapy provide these benefits? The product page on the advertiser's website states:

Stemtech’s SE2® is the world’s first all-natural supplement documented to support the release of adult stem cells from bone marrow. Our advanced supplement puts more stem cells in the bloodstream, and the effect lasts longer.

An advancement in Cellular Renewal – helping Nature do what it is designed to do

This 'advanced supplement' doesn't come cheap, of course: a bottle of 60 capsules costs £60.95 (plus shipping), but it might seem a bargain if the claims stood up to scrutiny.

But this product isn't regulated by the Human Fertilisation and Embryology Authority or even the Medicine and Healthcare products Regulatory Agency (MHRA): it isn't stem cell therapy derived from bone marrow, umbilical cord blood, etc, but simply a food supplement.

As a food supplement, the only claims permitted in advertising are those listed on the EU Register of nutrition and health claims and in the UK, those advertising claims are regulated by the Advertising Standards Authority (ASA).

Because we didn't believe the claims being made were authorised claims, we submitted a complaint to the ASA.

While we were at it, we looked further at the advertiser's website and included complaints about some of their other products: Jamu (cached), Forever Freedom® Aloe Vera Juice (cached), Serrapeptase (SerraEnzyme)- High Potency Capsules (cached) and PainSolv MkV Class IIa Medical Device (cached).

The page for the Jamu product no longer exists and the advertiser appears to have completely removed it from their website, but they had claimed:

Jamu (formerly Djamu) is traditional medicine in Indonesia. It is predominantly herbal medicine made from natural materials, such as parts of plants such as roots, bark, flowers, seeds, leaves and fruits. Materials acquired from animals, such as honey, milk, Ayam Kampung eggs and goat’s bile, are also often used.

…and they listed more than a dozen products in the range with descriptions such as 'Cholesterol Control', 'Naturally Lowers Blood Pressure', 'Naturally Dissolves Kidney Stones' and 'Naturally Reduces Blood Glucose Levels'.

ASA investigation

The ASA originally said they would contact Life Long Products and ask for their comments on several points they identified in the website advert for PainSolv references to pain reduction and management; some of the claims were made in a video on their website, but which is also within the ASA's remit. The advertiser could then provide the required evidence to substantiate the claims or agree with the ASA to remove the claims.

For the other points of the complaint about the supplements and Jamu herbal product, the ASA said those were sufficiently straightforward and would take them up informally with the advertiser, asking them to:

…remove the health and disease claims from their Stem Cell Therapy, Aloe Vera and Serrapeptase, and to remove the Jamu products from their marketing activity.

Although not stated, we believe the Jamu products were unlicensed medicines that would be a breach of the Human Medicines Regulations 2012 to advertise, supply or sell to the public and we're pleased to see that there is now no reference to these products on the advertiser's website.

Serrapeptase has, of course, been the subject of a previous complaint of ours against an advertiser in What Doctors Don't Tell You. That time, the ASA adjudicated on the evidence Good Health Naturally provided but ruled it was not adequate to substantiate the claims made. They upheld our complaint on all four points, identifying eight breaches of their CAP Code.

However, instead of providing evidence to substantiate their claims for PainSolv, the ASA notified us that the advertiser had agreed to:

…implement suitable changes to their website to bring it in line with the CAP Code.

So, instead of an adjudication, the ASA have today published the outcome of our complaint as an informally resolved case.

Except...

Except… although the advertiser has removed all mention of their Jamu products from their website, we see no other changes as yet.

If those pages don't change soon, we'll bring them to the attention of the ASA.

HealthWatch UK

The charity HealthWatch (not to be confused with the recent NHS organisation "Healthwatch England") has a study under way to test the effectiveness of consumer protection laws against misleading health claims.

A previous study by HealthWatch, Spurious Claims for Health-care Products: An Experimental Approach to Evaluating Current UK Legislation and its Implementation found some worrying results showing widespread variation in the application of consumer protection law and a reluctance to enforce it to protect consumers. Now is the time to build on that research with this bigger study.

Useful data are coming in, but more volunteers are urgently needed.

The study comprises these steps:

1. Request traders for evidence to support claims made on their websites. You will be provided with trader details, 5 for each volunteer.
2. Ask traders to stop making false claims.
3. Complain to Trading Standards, via the Consumer Direct website.
4. Follow up each complaint for six months.

All data are captured in a suite of online forms, and results will be submitted to a major journal.

If you are interested, please contact HealthWatch trustee Les Rose. Although it's not at all labour-intensive (so the current team reports), please only volunteer if you have the time.

12 August 2015