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"Undisputable evidence of scientific misconduct" by homeopaths

Also published as a guest post on the blog of Prof Edzard Ernst.

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: [email protected]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

Yet another bad year for homeopathy

Homeopathy prescriptions on the NHS in England fell by another 25% in 2017

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 of homeopathy in the NHS in England 2017

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).

The decline of NHS homeopathy Scotland 2016

Wales

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

The decline of NHS homeopathy Wales 2017

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 decline of homeopathy in the NHS UK 2017

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

Nelsons Homeopathic Pharmacy #3

The previous instalments of this saga covered the MHRA's role in dealing with our complaints against Nelsons Homeopathic Pharmacy. Now the GPhC…

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

May 2015So 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:

tubes

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

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
Cystitis
Detox support
Diarrhoea
Dizziness
Dry cough
Flu relief
Food poisoning
Gout relief
Grief and Bereavement
Haemorrhoids
Hangover
Hayfever & allergy
Healing combo
Healthy hair
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

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.

19 July 2016Complaint 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.

28 November 2016Complaint 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

Nelsons Homeopathic Pharmacy #2

It's been over two-and-a-half years since Nelsons Homeopathic Pharmacy last featured here. The saga continues…

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:

MHRA Nelsons decision 22 February 2018

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

The Society of Homeopaths: failing to make the case for homeopathy

Homeopaths publish ten studies they claim affirm the ‘potential benefits of homeopathy for a range of health problems’, but do they withstand scrutiny?

sugarpills1Homeopathy 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.

Read more: The Society of Homeopaths: failing to make the case for homeopathy

The end of homeopathy on the NHS in Bristol?

Bristol, North Somerset and South Gloucestershire Clinical Commissioning Groups (CCGs) are consulting on their proposal to decommission all NHS-funded homeopathy.

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


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