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PSA re-affirms official approval of the CNHC

Last year, we had concerns whether the Complementary and Natural Healthcare Council really had public protection at the heart of what they did. Despite failing to deal properly with our complaints, the Professional Standards Authority has just re-accredited them.

Note: this newsletter covers events that have taken place over the last 19 months and is necessarily long, detailed and involved. Even though this is a cut-down version, we believe it is important that the events are recorded and made public. But if all you need is a summary, jump to the end.

In May 2013, we said:

The CNHC recently applied to the Professional Standards Authority (PSA) to join their statutory Accredited Voluntary Register (AVR). With these revelations of the widespread and reckless claims being made by CNHC registrants, we suggest the PSA drop their application and have nothing further to do with them until the CNHC are able to fully demonstrate their ability to control their registrants and protect the public.

We had already begun testing the CNHC to see how they measured up to their own standards by submitting a sample batch of 100 complaints highlighting claims that our supporters were concerned about. We would like to thank all of those who helped us gather the details.

It was a long, slow process, but what was not ever clear was what that process actually was. One of the fundamentals of having a complaints procedure is that both the complainant and the complainee must know beforehand what process will be followed, how the complaint will be handled and how decisions will be reached. Transparency is everything if justice is to be done and seen to be done. We should expect no less from an organisation whose stated aim is to act in the public interest. There should be nothing done behind closed doors, out of the eye of public scrutiny lest there be accusations of favouritism, vested interests and putting members' interests before that of the public.

These are just the concerns that no doubt were in the minds of those drafting the Health and Social Care Act 2012 (HSCA) when they made provision for what was to be called the Accredited Voluntary Register. And no doubt there are worthy recipients of AVR accreditation. We do not believe, however, on the basis of past performance and on the way our current complaints have been handled, that the CNHC have met those expectations. Therefore we do not believe they deserve accreditation by a statutory regulator.

The OfQuack Paradox

The problem with organisations such as the CNHC is what has been called the OfQuack Paradox. OfQuack is the name many skeptics have given to the CNHC and — as we were told by Maggie Dunn, CEO of the CNHC over dinner several years ago — it is a moniker that has occasionally even been used by the CNHC themselves. There is also a parody Twitter account @OfQuack that claims to be the real regulator of quackery.

The OfQuack paradox goes something like this:

If a regulator of complementary/alternative/natural therapies were to do all they could to protect the public from misleading claims and treatments that had no good evidence base, their rules about what their members could claim or do would be so limited, no therapist would want to be a member, thus creating a perfect storm ending in their own demise.

There were signs that the CNHC were trying to do the job of a regulator properly when they wrote to Simon Perry five years ago. As Simon relates:

[Maggie Dunn, Chief Executive Officer] told me that as a regulator, the CNHC sees it as their duty to get in contact with alternative health course providers and authors. Given the nature of my original complaint, I expect this will enforce the view that claims must be justifiable.

What would a course on reflexology consisting only of justifiable claims cover exactly? How to spell reflexology?

This is so important, and so surprising I feel I need summarise in bullet points:

  • CNHC will tell practitioners to remove claims they cannot justify.
  • CNHC will conduct a review of evidence base for regulated therapies.
  • CNHC will contact all registrants to instruct them not to make claims without justification.
  • CNHC will contact complementary health course providers and authors to instruct them not to make claims without justification.

It is my view that adhering to the CNHC’s guidelines will make it impossible to practice complementary medicine.

It was clear to us that they had failed in this.

The only positive outcome of the external pressure that has been put on them has been the publishing of their 'Therapy Descriptors'. These are essentially information sheets about the various therapies they register and the claims the Advertising Standards Authority (ASA) would allow their members to make in their adverts. They are, because of the lack of good evidence for just about everything the CNHC's registrants do, somewhat bland.

However, as we found out when we asked our supporters to send us details of members' websites, these were being comprehensively ignored on a basis so widespread as to be endemic.

This is not the way an organisation purporting to uphold the requirements of the PSA's AVR standards should be acting, surely?

It was because of these endemic problems that we decided to bring them to the attention of the CNHC in the hope they would deal with them efficiently, swiftly, transparently and decisively in keeping with their aim of protecting the public.

We were to be disappointed.

We submitted our batch of 100 complaints on 28 May 2013.

CNHC Complaints Form

Example claims

To give just two examples, the claims we complained about included:

The Bowen Technique has been reported to help the following conditions: Back pain, sciatica and postural problems - Problems relating to the joints, including neck, hips, knee and shoulder - Asthma and hayfever - Frozen shoulder, tennis elbow - RSI, carpal tunnel syndrome -  Sports injuries - Arthritis - Headaches, migraines, anxiety, stress and insomnia - multiple Sclerosis and Parkinson's Disease - Respiratory problems - Digestive problems and IBS - Hormonal problems such as PMS and menopausal problems - Chronic fatigue, ME and low energy...

Craniosacral Therapy Can Also Help to Alleviate Arthritis, Asthma, Autism, Back Pain, Birth Trauma, Bronchitis, Cerebral Palsy, Colic, Depression, Digestive Problems, Drug Withdrawal, Dyslexia, Exhaustion, Effects of Cancer Treatment, Flatulence, Frozen Shoulder, Hormonal Imbalances, Hyperactivity, Immune System Disorders, Insomnia, Lethargy, Menstrual Pain, PMS, Migraine, Post-operative Problems, Post Traumatic Stress Disorder, Problems During and After Pregnancy, Reintegration After Accidents, Sciatica, Sinusitis, Spinal Curvature, Sports Injuries, Stress Related Illnesses, Tinnitus and Middle Ear Problems, TMJ (jaw) Disorders, Visual Disturbances, Whiplash Injuries. This is not an exhaustive list of conditions that may be helped by Craniosacral Therapy…

We thought all of these claims were questionable and certainly well outside the CNHC's Therapy Descriptors for Bowen Therapy and Craniosacral Therapy and the ASA's CAP Code.

More worrying were the claims about cancer.

Cancer claims

Amongst those 100 websites were six who were making claims about cancer. We decided the best way to resolve these and to discover how the CNHC would deal with them was to include them in our complaints.

The CNHC took swift action, contacting their members, requesting that they removed the claims and then passing the details on to their local Westminster Trading Standards to deal with as potential breaches of the Cancer Act 1939.

Yes, the CNHC reported six of their own members to Trading Standards.

We applaud them for that and for ensuring that the claims were removed as soon as possible. But they have not told us whether they preserved the evidence of the claims for cancer before they asked their members to remove them, so we don't know if Trading Standards had anything left to investigate.

Despite several requests, we have not been informed of the outcomes of any Trading Standards investigation, nor whether it resulted in any prosecutions.

The outcome of this was that the CNHC published new guidance on the Cancer Act to its members. It's a pity that their members needed to be reminded of their legal responsibilities.

But issuing guidance isn't enough unless there is a will to make sure it is adhered to.

Procedure? What procedure?

In dealing with the complaints, the CHNC's problems started with the fact that they had published two separate confusing and contradictory documents. The first was their Procedure for processing Complaints referred to the Complementary and Natural Healthcare Council (CNHC), dated December 2008 and 22 pages long. The second is titled Complaints Handling Process, also dated December 2008 but just four pages.

The much larger document contains detailed steps that are supposed to be taken at the various stages of a complaint and gives the procedures to be followed by the various committees when dealing with a complaint. The second document appears to be a brief summary of the main procedure.

We'll refer to the former as their detailed procedure document and the latter as their summary document below.

The problem is that the shorter one does not mirror the full procedure: it contradicts it in places and seems to describe a different process. A summary may well be a useful overview of how a complaint will be handled, but it is not — and cannot ever be — the definitive document, particularly when they don't actually agree. The longer, detailed document has to be the definitive one and the one any reasonable person would expect to be followed.

Does this matter? Well, yes it does. As I said above it is important that the procedure that is followed is the one that has been published for all to see so that both registrants and complaints know beforehand how a complaint will be dealt with. Chopping and changing rules and making them up as you go along don't fit in with the concept of natural justice. And we don't think it fulfils the requirements of the PSA's AVR Standard 11 a):

Provides clear information about its arrangements for handling complaints and concerns about a) its registrants and b) itself.

We believe we were correct in assuming and expecting the CNHC to follow their detailed, published complaints procedure.

They didn't.

Informally resolved

We submitted our 100 complaints in ten batches of ten, all clearly numbered and labelled, such as Group A-01-0001 <name> (<CNHC Registration number>).

After many emails back and forth where we tried to get the CNHC to tell us a) why they weren't following their detailed procedure document and b) what process they were following, they were adamant that they wanted to pursue all our complaints 'informally'. This meant that they were avoiding treating them as formal complaints despite the seriousness of many of the claims and simply wanted to sort things out quietly with their registrants without any fuss being made and, presumably, without having to say anything about it on their website.

Their detailed procedure made no mention of any process for informally resolving complaints nor any criteria by which it could be decided a complaint might be suitable of informal resolution.

But what it does say is:

PART III

COMPLAINTS

14 Procedure upon receipt of information about a Registrant

14.1 On receipt of information about a Registrant, the Council shall first consider whether such information is a Complaint.

14.2 Information shall only be considered to be a Complaint if such information:

a. relates to an identifiable Registrant; and

b. makes a specific allegation or allegations relating to the fitness to practice of a Registrant.

14.3 If the information is not considered to be a Complaint, the Council shall inform the provider of the information that no further action will be taken and that the matter will be closed.

14.4 In order to assist the Council in making a decision under 14.2 above, the Council may request further evidence from any relevant party.

14.5 If the information is considered to be a Complaint, the Council shall refer the case the Investigating Committee. The Complainant will be sent a copy of the Council’s guidance about making a Complaint and may also be informed of alternative methods of resolving disputes.

We believed we had fulfilled the requirements of 14.2 a) and b): these are the only two criteria stated that will be used to determine whether 'information about a Registrant' is to be considered a complaint or not a complaint. We were never told that we had not met those criteria.

Our arguments fell on deaf ears.

What we were told was:

CNHC’s view is that in the first instance it will attempt to seek to resolve these complaints through appropriate intervention and advice [though see (17) below in respect of clear breaches of the Cancer Act 1939].  Given the number of complaints you have made, consideration is being given to how best to achieve this.

and:

I re-iterate that in the first instance (in line with the general principle of proportionality) CNHC will seek informal resolution of the complaints.

The 'principle of proportionality' sound like a good idea, but it is not in their procedures and we believed the serious claims being made by their registrants merited a proportionally serious response by the CNHC. Having a quiet, off-the-record word with registrants doesn't do justice to the seriousness of the complaints.

Instead, they made it clear that they wanted to take a course of action other than that defined in their detailed complaints procedure.

But they did seem rather confused about their own procedures. We were told:

As I trust I made clear in my previous response, the published Complaints Procedure applies following a decision to refer a complaint to the Investigating Committee.  I also explained that in the first instance, in line with our published Complaints Handling Process, CNHC will be seeking to resolve your complaints through appropriate intervention and advice.  Your interpretation of my response, therefore, does seem to be somewhat of a misrepresentation.

Clearly, the published complaints procedure says no such thing: it defines how a decision to refer a complaint to the Investigating Committee (IC) is made and 14.5 states that a complaint meeting the two criteria will then and only then be referred to the IC. It is not — as the CNHC claimed — the procedure to be followed after a complaint has been referred. Indeed, if it was the case that the whole procedure applied only to IC referred complaints, in what other document are the criteria that define what invokes their detailed procedures?

The CNHC may well argue that their summary document does just that, but here, the CHNC simply get into deeper water. Their (summary) Complaints Handling Process document states:

How can a complaint be made?

Complaints referred to the CNHC will only be considered if the complaint is received on a CNHC completed complaints form addressed to the Registrar. Complaints received by the Registrar will be processed through an initial preliminary enquiry procedure to ensure that matters referred to the Council are within the remit of the CNHC.

Investigating Committee’s role

If the matter under consideration is within the remit of the CNHC it will be referred to an Investigating Committee (IC). The IC will initiate a screening process and examine all the evidence relating to the complaint.

The first paragraph defines a criterion that a complaint must be within the remit of the CNHC. To be expected, of course, but it requires no more than that.

The second paragraph clearly states that a complaint, if adjudged to be within the CNHC's remit will be passed to the IC who will then examine the evidence relating to the complaint.

None of our complaints ever reached the Investigating Committee.

One by one

The CNHC started to 'informally resolve' the complaints and told us about the first of them in August 2013, but they didn't complete them all until 31 January 2014, nearly 11 months after we submitted our complaints.

(We were told that three registrants had let their registration lapse prior to complaints about their websites being resolved, leaving 97.)

Each time, we were told:

I attach herewith copies of a further xx complaints that have been resolved informally ie either the wording complained of has been removed from the relevant website or has been amended in line with advice that the registrant has sought from the Committee of Advertising Practice Copy Advice Team.

At least all these websites had been checked, claims removed or amended on according to advice from the ASA.

A good job (eventually) well done.

Except…

A few months later, we decided to look at a small sample of the supposedly amended websites to see what they now said. 

Guess what we found?

This, from just two websites:

Abscess, Acne, Alcoholism, Anaemia, Angina, Anxiety, Arthritis, Asthma, Bloated Stomach / Wind, Breast Pain / Cysts, Blood Sugar Imbalance, Blood Pressure, Bruises, Candidiasis, Fungal Infections & Yeast, Cellulite, Cholesterol, Circulation, Coeliac Disease, Cold Sores, Colds & Flu, Colitis , Constipation, Crohn's, Cystitis, Dandruff, Diabetes Mellitus, Diarrhoea, Depression, Diverticulitis, Exhaustion / Fatigue/Tiredness, Endometriosis, Eczema, Electromagnetic Sensitivity, Gallstones, Glue Ear, Gout, Halitosis, Hayfever, Hot Flushes, Herpes Simplex, Heart & Arteries, Headache, Hypoglycaemia, IBS, Impotence, Immunity, Insomnia, Lymphatic Congestion or Lymphoedema, Libido, Lyme Disease, ME - Chronic Fatigue Syndrome, Mood Swings, Migraine, Menopause, Memory / Concentration Loss, Muscle Pain, Nausea, Osteoporosis / Porous Bones, Overweight, Parasites, Prostate, Polycystic Ovaries (PCOS), Premenstrual Tension - PMT, Periods, Psoriasis, Sinusitis, Stress, Thyroid - Hypothyroidism - Underactive Thyroid, Thyroid Unexplained Weight Gain, Toxin Elimination.

Asthma, Asthma revisit, Babies, Back Pain, Bear Grylls' battle with back pain, Bell's Palsy, Birth Traumas, Born Survivor, Bowen , Integration and Wholeness, Bowen and Health Care, Bowen Technique, an effective complement, Braces and loss of wellbeing, Cerebral Palsy, Children and anxiety, Drug and alcohol abuse help, Eczema, Engaging the immune system, Exercise induced tachycardia, Fibromyalgia, Giving the Right Signals, Healing Power of Gentle Touch, Hydrocephalus and hemiplegia, Knee and ankle study, Lingering symptoms, Lump in the throat, Lymphatic drainage, Lymphoedema, Ménière’s disease, Migraine help, Migraines, Mind-body integration, Mothers and Babies, Motor Neurone disease, Neck pain becomes history, Pain and Anxiety, Pain Control, Parkinson’s Disease, Pelvic area treatment, Peripheral Neuropathy, Post head-injury problems, Respiratory treatment with Bowen, Rheumatoid arthritis, Seasonal Allergic Rhinitis, Sinus – chronic problems, Sleep problems, Slipped discs, Sound Learning Centre, Sport and Bowen, Tinnitus, TMJ Syndrome, Veterans – help with recovery.

These are serious claims and we expected complaints about these to be treated seriously, particularly since we had already pointed these out to the CNHC and was assured everything had been sorted.

Down to ten

We gave the CNHC a list of just ten websites and asked them to confirm whether they were confident all the pages of these websites were now compliant with their Code of Conduct, Performance and Ethics, their advertising and Cancer Act guidance and Therapy Descriptors.

After consulting their Board, we were eventually told:

…the Board can assure you that at the time when your complaints against 100 CNHC registrants were resolved informally, it is confident that the identified websites complied with the Cancer Act 1939 and the Committee of Advertising Practice (CAP) Code

That answered a question we didn't ask; we wanted to know whether the CNHC believed they were complaint now, not six months to a year ago.

We think a responsible regulator would at least have looked at the websites we gave them and taken action on anything it found; it should certainly not have to wait for a member of the public to complain. We do not know whether the CNHC even looked at the websites.

Since it seemed the CNHC didn't want to do anything with the information we gave them, we felt we needed to make these complaints formal, even though we considered them to be a continuation of the original complaint that had not been properly dealt with.

The CNHC wanted the complaints on their special form and a 'hard or scanned copy of the website pages' we were complaining about. Neither of these requirements are specified in their detailed complaints procedure and we hadn't provided any hard copies of web pages in the original complaints.

However…

We supplied the complaints on their special form, including a list of the urls of the specific pages we had concerns about.

The CNHC wanted us to identify the specific wording on each page we were complaining about.

We argued that the words needed to be seen in the context of each page and that we were therefore concerned about all the wording on the pages we listed.

The CNHC still wanted the 'specific wording' that was the subject of our complaint.

We supplied a large file that contained screenshots of the webpages with specific wording identified with a yellow highlight on each page, but we reiterated that we were concerned about all the wording on those pages.

The CNHC seemed surprised at the number of screenshots we provided; we don't know why, since it corresponded to the number of pages whose urls we had already supplied to them. There were a lot of pages and a lot of highlighted text because these were the claims being made by their registrants! There is not — nor should there be — a word limit on the number of misleading claims being complained about.

Some of the text we highlighted was single words or phrases; sometimes paragraphs and sometimes complete pages:

Highlighted text

Click image to enlarge

As you can see, context is everything and it would have been trying to extract any few words out of any of these. In all these files, we had highlighted some text on every page, but, given the nature of some of the pages and documents, the claims being made and the context in which they were being made, some pages had most of the text highlighted. We were not comfortable picking out any specific words and felt that it was not our responsibility to isolate concerns about just a few specific words and expected the CNHC to have taken responsibility for doing that as part of their formal process.

If we had isolated some words, we believed that the CNHC would look only at those few words themselves, ignoring the rest. We had been given an assurance that claims would be looked at in context, but we had no confidence that this would be done such it covered all the areas we were concerned about. We were therefore left with no option but to try to insist that the CNHC accept our complaints as we had submitted them without weakening them by cutting back on the words we were concerned about.

As we understood the complaints process, it was the responsibility of the CNHC’s Investigating Committee to take the complaint information, examine the evidence provided and identify any potential breaches of their Code and, from that, determine if there was a case to answer and to then derive Formal Allegations to be presented to their Conduct and Competence Panel.

The onus cannot be placed on a complainant to identify and formulate specific and detailed allegations; all that a complainant should be required to do is to present information to the CNHC and for them to decide whether or not, after due investigation and consideration, that information was sufficient evidence with which to proceed with a complaint and that there was a case to answer.

Think of a customer who was not satisfied with the treatment received. It might have been possible for her to have formulated her complaint such that it isolated the very specific concerns she had and to detail how the Code of Conduct, Performance and Ethics had been breached, but it is entirely right, reasonable and appropriate for the CNHC, with their knowledge and expertise, to make all efforts to understand the issues and to help her formulate a complaint that highlighted those issues.

In our case, the CNHC seemed to expect us to isolate specific words that breached their Code, to the possible detriment of ignoring everything else.

Vexatious?

The CNHC still maintained that we had 'to identify in each case the specific wording that is the subject of your complaint'.

We believed we had already done that and pointed this out yet again to the CNHC.

On 17 July 2014, the CNHC told us:

You state you have provided “...just one file per url”. I have made a quick check and in one instance the file provides individual links to 75 pages. In total there appear to be links to 180 or so pages. Bearing in mind this and your reiterated statement that all of the text on all the pages specified are the subject of your complaint, I will be asking the CNHC Board to consider whether your complaints should be categorised as vexatious, on the following grounds

• you have failed to specify precisely what you are complaining about

• you are seeking to make unreasonable demands on CNHC resources

The next meeting of the Board is scheduled for 6 August and I will be in touch with you again after that.

We were at a loss to understand what it was going to take to get the CNHC to take complaints about their registrants making the claims such as the ones above seriously and act in the public interest?

In one final attempt, we reiterated many of the claims we had found on those websites and that the ASA's guidance on Health Therapies and Evidence QA (Sept 2011) states:

Marketers should be mindful that merely listing medical conditions could imply their treatment or therapy is effective.

We didn't know how to make this any clearer. We had given them 'information about a registrant' as required by their complaints procedure; we had provided the complaints of their own forms; we had listed the website pages; we had specified what wording concerned us; we had provided screenshots of those pages.

What does it take to get a regulator to consider serious complaints about serious issues of public protection?

The final six

The CNHC informed us that four more registrants had let their membership lapse: we were now down to just six complaints.

We had fully expected the CNHC to rule our six complaints vexatious and to dismiss them, but they surprised us on 12 August by giving us one last chance to identify the specific wording (even though we had already done so).

Oh, and they created a new document, dated 08 August 2014: Policy for dealing with Vexatious Complaints and Abusive Complainants.

Meanwhile…

A few weeks before we submitted our initial 100 complaints in March 2013, the CNHC applied to the statutory Professional Standards Authority for Health and Social Care for accreditation for their Accredited Voluntary Register scheme that was set up under the Health and Social Care Act 2012 (HSCA).

This seeks to ensure the public are protected by ensuring accredited organisations meet certain standards in relation to their operation. They say they make no judgement on the efficacy of any treatment provided by any organisation who is accredited, but the implication is there that an organisation backed by a statutory body — and the same one that oversees the GMC, GDC, etc — must be of high quality and provide good treatments.

We did not believe then that the CNHC could meet the required standards and that accrediting them would do no more than give members of the public a misleading and false impression that the CNHC would deal effectively in the best interests of the public.

We responded to the PSA's Call for information on the CNHC's application, giving our reasons.

One of our main objections was that the AVR was intended to cover ''health and/or social care occupations’. We analysed what the HSCA actually said in its convoluted way and argued that occupations that had no good evidence of any healthcare benefit (as the vast majority of the occupations that the CNHC register) could not meet the requirement of being a 'health and/or social care occupations’ and therefore could not be accredited.

The PSA disagreed but never really rebutted our objections; overall, they did not agree with our recommendation that the CNHC not be accredited.

However, we know from their Panel Decision report that the CNHC did not have an easy time of it, partly due to our response and partly to what others told the PSA about their concerns — it took the PSA six months to consider the application. They gave several recommendations:

Recommendation 1: Quality Assurance Project – participation of verifying organisations (VOs) in the quality assurance project is essential and should therefore be mandatory. CNHC should provide a plan highlighting when it will receive and review evidence submitted by all VOs.

Recommendation 2: Integrity of the Register – CNHC should have a mechanism in place to ensure that all its registrants comply with its education and training standards, particularly those who had been practising for four years or less at the time of initial registration with CNHC.

The Panel considered two scenarios: a) the evidence submitted through the quality assurance project may demonstrate that a specific verifying organisation might not have appropriately applied the standards required for CNHC registration (non-compliant case); b) some verifying organisations are not engaged in the quality assurance project so CNHC is unable to assure that its criteria are being applied appropriately (non-engaged case). In both cases, CNHC should have a mechanism in place to assure itself that registrants verified by non-compliant and non-engaged verifying organisations still meet its education and training requirements.

Recommendation 3: Enforcing and Promoting standards – CNHC should have a plan in place that demonstrates how it will proactively promote and enforce its Code of Conduct amongst registrants, particularly, sections related to misleading advertisement. The plan should include active promotion of its advertising guidelines and other relevant codes/advice from the Committee of Advertising Practice and Advertising Standards Authority.

The first two are essentially technical ones to do with how the CNHC rely on VOs to check potential registrants are 'properly' trained. This could be the subject of a future newsletter.

But the third demands that the CNHC has a plan to 'proactively promote and enforce its Code of Conduct amongst registrants, particularly, sections related to misleading advertisements'.

They also imposed the following conditions:

Condition 1: CNHC must have a single complaints procedure where the criteria for handling and recording of these complaints both informally or formally are explicitly clear to the public and explain the types of complaints for which informal resolution is not suitable (e.g. dishonesty, fraud, repeated complaints and so forth). Its criteria and process for escalating complaints from informal to formal procedures must also be clear to the public.

Condition 2: The 110 complaints discussed in the resubmitted application must be assessed according to procedure and either resolved informally where appropriate or escalated to formal resolution, i.e. sent to the Investigating Committee. The AVR team should be notified when all complaints have been resolved or escalated to formal resolution. A plan for resolution of all complaints should be provided with notification.

CNHC had until the 31st of October 2013 to comply with conditions.

CNHC-AVR logoThe first is an attempt to clear up the confusion of having different complaints documents saying different things — just as we have described above.

The second condition of accreditation was that they should have a plan to deal with our then 100 complaints. Disappointingly, it seems to accept that the CNHC can informally resolve complaints, despite this not being part of their published complaints process document.

As a result, the CNHC amended their documents.

AVR accreditation permits members of the organisation to use the AVR logo as a sign of respectability; any CNHC member can display their combined logo.

However, the accreditation has to be renewed every year and the annual call for information for their first renewal was announced on 04 July 2014. Their accreditation ended on 23 September, but is maintained while the annual re-appraisal is being undertaken if it has not finished before the previous accreditation expires.

Re-accreditation

We, of course, responded to the PSA's call for information, taking the opportunity to bring the PSA up to date on how the CNHC had still not dealt with our complaints and how — as far as we could see — none of the claims we had highlighted to the CNHC had been removed from websites of their registrants and why we still had serious concerns about claims being made on some of their members' websites. We included in that a complete record of our correspondence with the CNHC, amounting to some 30 pages, so they could see how the CNHC had dealt with our complaints.

That re-appraisal process has been completed and the PSA have now published their AVR Panel decision stating that the CNHC's accreditation is being renewed for another year.

PSA Accredited Register logoAt this point, it should be noted that the PSA have changed the name of their Accredited Voluntary Register. For reasons best known to them, they recently changed the name to Accredited Register, dropping the word 'Voluntary'. It is not clear why this could be seen as a step in the right direction at all; it simply hides that these registers are voluntary. It is possible that a member of the public will now see these registers as having the equivalent standing to the PSA's statutory registers it oversees such as the GMC, GDC, etc.

There are several interesting points to be made about the PSA's re-accreditation report, but we'll confine ourselves to what they say about our complaints here. The relevant section states:

The Panel then discussed the concerns related to six registrants’ websites allegedly in breach of advertising standards, CNHC’s Code and therapy descriptors. The Panel was informed that CNHC had asked for more specific information about the exact wording that was the cause of the complaint for each of the websites in line with their complaints procedure. The Panel was told that the complainant had submitted electronic links to CNHC (182 files in total) where sometimes whole paragraphs were highlighted as causing the complainant concern. The panel was also told that the complainant stated that their concern related to all the text on all the specified pages. CNHC Board had decided that in the interest of fairness and reasonableness it was right that registrants knew precisely what was being complained of. The Board had asked the Registrar to give the complainant another opportunity to specify the words they were complaining about otherwise the complaints would be classified as vexatious under CNHC’s recently published ‘Policy for dealing with vexatious Complaints and Abusive Complainants’. At the time of the panel meeting CNHC informed the Authority that it had contacted the complainant to inform them of the Board’s decision above.

After discussing the provided information the Panel decided to call CNHC’s Registrar during the meeting in line with AVR process to ask whether or not CNHC could assure itself and the Authority that the concerns raised did not identify any risk to public protection. The Registrar clarified that CNHC did not consider the concerns raised to be complaints as yet because they have not received the specific information they need in order to inform the registrant what was being complained about. The Panel agreed that in fair process registrants had a right to know what was being complained about and that CNHC was following their documented complaints procedure. Having considered the information provided by the Registrar the Panel decided that, not withstanding whether or not the concerns raised with them constituted formal complaints, the CNHC should satisfy themselves and the Authority that there were no issues with the websites that raised any risks to public protection and issued the Instruction set out above. CNHC was asked to provide an update to the Authority in three months from the date of the outcome letter.

There are two main points to be made here:

  1. The CNHC did not consider the concerns raised to be complaints as yet because they have not received the specific information they need in order to inform the registrant what was being complained about.
  2. The CNHC should satisfy themselves and the Authority that there were no issues with the websites that raised any risks to public protection.

Firstly, it beggars belief that the CNHC do not, as yet, consider our six complaints as complaints — despite having complied with what their detailed procedure document states — and that they won't do so until they have received what they deem to be the 'specific information'. In fact, we don't really even see them as new complaints at all, but as examples of the first 100 that have not yet been resolved.

Secondly, it also beggars belief that the CNHC — despite being made aware of the specific concerns we had last March — could not assure the PSA that that there were no issues with the websites that raised any risks to public protection and have to be given a further three month in which to do so.

It's difficult to fathom why claims such as those we have highlighted above could not be a serious cause for concern to any organisation that had one iota of concern for public protection. In what world does making claims for asthma, Diabetes Mellitus, depression, autism screening, ME, cerebral palsy, Ménière’s disease, Parkinson’s Disease, hydrocephalus and hemiplegia and post head-injury problems not raise concerns for public protection?

Serious questions

Remembering the OfQuack Paradox, we can perhaps expect this kind of behaviour from the CNHC, but what — and this is perhaps the more serious question — will it take for the PSA to stop giving legitimacy to such an organisation? How serious do claims have to be before they are beyond the pale even for the PSA?

In one of their FAQs, the PSA states:

Does accreditation mean that a particular therapy is better than others?

No. Accreditation does not validate the efficacy of a particular therapy. This means that the Authority will not test whether or not a particular therapy has better results than other therapies.

…or whether any therapy has any good evidence of efficacy at all.

This is a direct consequence of the HSCA because it has no explicit requirement that any therapies of accredited registers be evidence-based — or even reality-based.

But the PSA does have the power to act when an accredited regulator fails to follow its agreed procedures and fails to protect the public, yet it seems it won't act when serious concerns are raised and ignored by an accredited organisation.

So what would it take? Would they only act after someone has been harmed by misleading advice given out by a member of one of their accredited organisations. We just don't know.

However, although we have been at an impasse, we have now provided the CNHC with a spreadsheet containing the 'specific wording' they have asked for and we hope they will now properly deal with our complaints.

We will, of course, keep you informed.

TL;DNR

The Too Long; Did Not Read version…

  • We were concerned about claims being made by CNHC registrants that might mislead the public.
  • With the help of our supporters, we gathered details of claims being made and submitted complaints about 100 registrants to the CNHC.
  • The CNHC told us they wanted to resolve them 'informally, even though their published procedure didn't allow for this.
  • We were (eventually) told they had all been resolved.
  • We checked ten websites and were concerned at the claims still being made.
  • We tried to get the CNHC to deal with six of these complaints and they were on the verge of declaring them 'vexatious'.
  • Meanwhile, the statutory Professional Standards Authority (PSA) accredited the CNHC to their Accredited Voluntary Register, despite being made aware of serious concerns.
  • As part of their first annual re-accreditation process, we submitted our account of the way the CNHC had handled our complaints and our concerns over this, maintaining that the CNHC had breached the AVR Standards.
  • The PSA re-affirmed the CNHC's accreditation regardless.
  • We have now cut down the words we were concerned about and sent them to the CNHC.
  • We await the final acceptance of our serious concerns as complaints and to them being dealt with properly in a manner we expect of an organisation purporting to act in the public interest — and of one given the imprimatur of a statutory regulator.

07 December 2014


 

More needling

We had hoped that all acupuncturists would have got the point after the adjudication by the Advertising Standards Authority (ASA) that upheld our complaint against the Royal London Hospital for Integrated Medicine (RLHIM).

It seems we were too hopeful.

Although we didn't know it at the time, it looks as if the acupuncture treatments that the RLHIM were advertising might well have been provided by the British Medical Acupuncture Society, run as a private clinic on the third floor of the building.

We'll return to that below, but first, we'll look at what goes on in the RLHIM building.

Rented space

As part of our investigation into the RLHIM, we submitted a Freedom of Information Act (FOIA) request to UCL Hospitals NHS Foundation Trust (UCLH) and the neighbouring Great Ormond Street Hospital for Children (GOSH), which is run by a separate Hospital Trust. We wanted to find out about the RLHIM's hiring out of their building, how much was left for the RLHIM's own activities and what income they received from this. Of course, the RLHIM don't actually own the (seven-floor) building they use — it's owned by UCLH.

GOSH replied within the statutory 20 working days; UCLH were tardy in providing the information and exceeded the statutory 20 working days, but eventually replied.

RLHIMWe now know that:

  • GOSH rent all of the first, fourth and fifth floors and part of the second from the RLHIM.
  • The third floor is an outpatient clinic with consulting rooms used by the National Hospital for Neurology and Neurosurgery (NHNN), the RLHIM and the Eastman Dental Hospital (EDH).
  • The NHNN share the lower ground floor, ground and third floors with the RLHIM and uses part of the second floor for their Daycare Unit.
  • One room on the third floor has been rented out to the British Medical Acupuncture Society since 2005 (when the RLHIM had their £20 million makeover).

In terms of the rental and other costs:

  • The BMAS pay £6,469 per annum to the RLHIM.
  • The amount paid by GOSH in 2012/2013 was £448,071 annual service charge plus £153,734 rent giving a total of £601,805 per annum.
  • The total income to the RLHIM from renting out parts of the building in 2012/2013 was £608,274.
  • This GOSH arrangement started in 2005 and the total GOSH has paid the RLHIM is just under £5 million.
  • The RLHIM and the NHNN are part of the Queen Square Division of UCLH Trust, so there are no internal recharges for the use of the building.

RLHIM - mapWe were unaware that the BMAS rented a room at the RLHIM when we submitted our ASA acupuncture complaint, but even Google knew — click on the map! But I'm sure the irony of an organisation called the The Advertising Protection Agency (wrongly) shown as also being at the RLHIM will be lost on no one.

Sharing

This means the RLHIM shares the lower ground and ground floors, some of the consulting rooms on the third and has part of the second floor for its own use.

This also means that the RLHIM has no exclusive use of any of the seven floors of its own building. 

We have figures for the floor areas that GOSH rent and, making a few assumptions, we estimate that the RLHIM only uses about 60% of its own building, sharing it with others.

Into this, they squeeze the following clinics and facilities:

There may be a few other clinics there as well, but they seem to have withdrawn the advertising for their Marigold Foothypnotherapywestern herbal and, of course, their acupuncture clinics for some reason

(GOSH, of course, don't provide any treatments to children that are available at the RLHIM.)

CAMLIS must take up a good bit of space on the ground floor since it contains:

  • 4000+ books on open shelves (others can be fetched from the stacks)
  • 40+ current journals on the shelves (back files of another 200 journals in the stacks)
  • Computers for access to a broad range of medical databases, e-journals, e-books

But, what if the RLHIM was to shut up shop? Perhaps more space could be rented to other hospitals? Even at the rate paid by GOSH, this would earn UCLH just under £1 million a year; rent it out at commercial rates for the area of Bloomsbury and it could increase UCLH's coffers by a cool £2.8 million per annum. Just imagine what UCLH could do for patient care with that amount!

Acupuncture

But back to the acupuncture clinic.

The FOIA response told us the British Medical Acupuncture Society run an acupuncture clinic in a room on the third floor of the RLHIM building. They call it their London Teaching Clinic, claiming:

The BMAS runs an acupuncture teaching clinic in the centre of London. This clinic is established as a centre of excellence for acupuncture treatment in the heart of London and provides a training base for medical acupuncturists.

The BMAS is working to integrate acupuncture within the NHS. However, at present patients at the London Teaching Clinic are treated on a private basis. The Clinic operates on a not-for-profit basis and charges are relatively affordable.

Now, it may be that the RLHIM's Group Acupuncture clinic was run by RLHIM staff and not the BMAS, but, since the BMAS have run their private clinic in the RLHIM for some ten years, it seems highly unlikely that they were unaware of the ASA's investigation into the RLHIM's group acupuncture clinic. Indeed, the RLHIM submitted some 43 papers trying to substantiate the claims they were making — would they not have informed or consulted the BMAS, particularly when the latter claim to be:

…a nationwide group of about 2300 registered doctors and allied health professionals who practise acupuncture alongside more conventional techniques.

That would appear to be right up the RLHIM's street, since they claim to offer:

…a range of therapies which are fully integrated in to the NHS and with conventional medicine.

All therapies are provided by registered health professionals who have additional training in complementary medicine.

Anyway, the BMAS were claiming they can treat a range of conditions that were very similar to those claimed by the RLHIM.

In their London Teaching Clinic leaflet, they said:

What sort of conditions respond to acupuncture?

Acupuncture appears to be effective in a wide range of painful conditions and is commonly used to treat musculoskeletal pain: for example – back and leg pain, shoulder pain, neck and arm pain. It has been successfully used to treat headaches, migraines, trapped nerves, chronic muscle strains and various kinds of rheumatic and arthritic pain.

Some other situations in which acupuncture might be used are:

  • Functional bowel or bladder problems such as IBS or irritable bladder, and even mild forms of urinary incontinence
  • Menstrual and menopausal symptoms
  • Allergies such as hayfever, perennial allergic rhinitis, and some types of allergic rashes such as urticaria or prickly heat
  • Some other skin problems such as discrete rashes and ulcers, pruritus (itching), some forms of dermatitis, and some cases of excessive sweating
  • Sinus problems and chronic catarrh
  • Dry mouth and eyes
  • Smoking cessation.

This is not a complete list and many other conditions have been treated with acupuncture.

They also made claims about electroacupuncture for addictions, acupuncture for smoking cessation and weight loss.

They made almost identical claims in their Patient Info leaflet.

In the ASA's adjudication of the RLHIM's acupuncture clinic, they included both the Group Acupuncture clinic leaflet and their Traditional Chinese Acupuncture (TCM) [sic] leaflet. The ASA, after examining all the evidence the RLHIM provided and after consulting an expert, concluded that the RLHIM had not substantiated the claims they had made and were told to remove them all.

The TCM leaflet made claims about:

Women's health, including disturbances of the menstrual cycle, gynaecological disorders - Men's health, including prostatitis, urinary disorders, fertility - Emotional issues, stress, anxiety, depression, addictions - Headaches, migraines, tinnitus, dizziness, vertigo - Sleep disturbances - Immune system imbalances, allergies, Herpes zoster (Shingles) - Gastro-intestinal conditions - Musculoskeletal problems including joint pain, back pain - Upper respiratory disorders e.g. sinusitis, asthma - Hypertension (High blood pressure)".

And the other leaflet:

The acupuncture at RLHIM is Western Medical acupuncture. It has been proven to be effective in the treatment of pain and muscular spasm ... Group Acupuncture Clinics are offered for: - Chronic Knee Pain (including knee osteoarthritis) - Chronic Musculoskeletal pain (including back and neck pain) - Chronic Headache and Migraine - Menopausal complaints (including hot flushes) - Facial Pain".

We leave it to you to spot any similarities between these and the claims the BMAS were making.

Referrals

We also questioned the claims in their Acupuncture Referral Guidelines — many overlapped those in the other two leaflets, but this was a far longer list that started by stating:

The following is a list of conditions, diagnoses and symptoms for which acupuncture treatment can be used. The categories are placed roughly in order of response rate, starting with the highest.

They didn't say what evidence they used to determine the response rates.

However, the ASA concluded that it was not within their remit because it was addressed to medical practitioners rather than the general public. We argued that there was nothing to say it was and that it was available to anyone. The ASA were not convinced by our argument and so dropped this part of our complaint.

Outcome

The ASA intended to deal with our complaint under their formal investigations procedure, asking the BMAS to comment on our complaint and provide evidence to support their claims.

However, the BMAS eventually decided to simply assure the ASA that the claims investigated and similar claims would not appear again.

It might have been interesting to see what evidence the BMAS provided to the ASA and see if it was any different to that supplied by the RLHIM, but, in the end, the outcome would almost certainly have been the same: the misleading claims are removed.

So, today, the British Medical Acupuncture Society are listed on the ASA's website as having informally resolved the case.

Changes

But have the BMAS kept their promise to remove the claims?

A new London Teaching Clinic leaflet (cached) was created on 01 May 2014, very shortly after we submitted our complaint, but we don't know if changes were made because of our complaint. However, the new leaflet states:

What sort of conditions respond to acupuncture?

Acupuncture is proven to be effective in a wide range of painful conditions and is commonly used in short term relief of musculoskeletal pain, including chronic low back and neck pain, knee osteoarthritis pain, migraine and tension–type headache, and temporomandibular (jaw joint) disorders (TMD)

Some other situations in which acupuncture might be used are: the symptoms of overactive bladder syndrome; shoulder pain; nausea and vomiting.

Research has shown that there may be benefits to women’s health particularly in women with polycystic ovary syndrome. In this situation acupuncture can improve ovulation rates and beneficially alter hormone levels.

Clinical research has yet to confirm whether or not acupuncture is useful a useful therapy to aid weight loss, control appetite or help with smoking cessation.

Their Patient Info leaflet (cached) was also updated on the same day. The first and last sentences are the same, but the middle two are oddly different:

Some other situations in which acupuncture might be used are: improvement in the symptoms of overactive bladder syndrome; elbow and shoulder pain; facial and dental pain; nausea and insomnia.

Research has shown that there may be benefits to women’s health including treatment for painful periods; fertility issues and IVF; menopausal conditions such as hot flushes and night sweats.

The ASA's current guidance on acupuncture (which extensively cites our RLHIM adjudication) states:

In light of the evidence reviewed, CAP accepts that practitioners of acupuncture may provide the following:

  • Short-term improvement in the symptoms of overactive bladder syndrome (through electro-acupuncture at the SP6 point)
  • Short-term relief of tension type headaches
  • Short-term relief of migraine headache
  • Short-term relief of chronic low back pain
  • Short-term relief of neck pain or chronic neck pain
  • Short-term relief from temporomandibular (TMD/TMJ) pain
  • Temporary adjunctive treatment for osteoarthritis knee pain

CAP is unlikely to accept claims that acupuncture can treat tinnitus or can control appetite. Although commonly claimed, we have not seen evidence that acupuncture can either help quit smoking or aid weight loss (Chinese Medicine Centre, 14 January 2004). Claims that acupuncture can help detoxify the body, improve blood circulation, increase metabolism, boost energy, deal with feeling blue, general facial pain, trouble sleeping, elbow pain or shoulder pain are likely to be problematic.

It is possible to advertise the purely sensory effects of acupuncture and make claims about well-being and well-feeling or to use phrases such as “feel revitalised”, “more positive” or “relaxed”. The ASA is yet to be presented with appropriate evidence that acupuncture can be beneficial for those suffering from dental pain and nausea and advertisers should ensure they hold robust evidence before making such claims.

Their leaflets are certainly an improvement on the previous ones, but they still contains claims that don't match what the ASA says are acceptable.

We'll be bringing this to the attention of the ASA and let them decide if they agree with our concerns.

When they again update their leaflets, perhaps the BMAS will take the opportunity to make similar changes to other pages on their website — such as Patient Information and Questions?

20 August 2014 


 

More misleading claims at NHS Homeopathic Hospitals

The adjudications by the Advertising Standards Authority about claims made by homeopaths and the Royal London Hospital for Integrated Medicine have all been published, so why were the Glasgow and Bristol Homeopathic Hospitals still making questionable claims?

Drug Delivery at the Glasgow Homeopathic HospitalWe won ASA complaints last year over claims made by the Royal London Hospital for Integrated Medicine (RLHIM) about Medical and Clinical Hypnosis, Acupuncture, Western herbal medicine and marigold therapy. The ASA has also ruled on complaints about claims for homeopathy made by the Society of Homeopaths, homeopath Steve Scrutton (and again) and the homeopathy lobby group Homeopathy: Medicine for the 21st Century.

There's been the House of Commons Science and Technology Select Committee Evidence Check on homeopathy in 2010 that concluded:

11. In our view, the systematic reviews and meta-analyses conclusively demonstrate that homeopathic products perform no better than placebos.

The ASA also offer advertising advice about a wide range of alternative therapies and there are our other successful complaints to both the ASA and the medicines regulator, the MHRA.

So it comes as a surprise to find another two NHS hospitals making claims in a leaflet and on their websites for homeopathy, holistic approaches to cancer and depression, acupuncture, allergies and anthroposophic medicines (including mistletoe therapy for cancer).

The Glasgow Homeopathic Hospital (GHH) is one of just three hospitals left that are funded by the NHS — Tunbridge Wells Homeopathic Hospital closed in 2008 and the Homeopathic Hospital in Liverpool effectively disappeared a few years ago as well.

Part of NHS Greater Glasgow and Clyde, the GHH is located on the site of Gartnavel General Hospital. Like the Royal London Homeopathic Hospital, they are trying to re-brand themselves as the Centre for Integrative Care. It has its own website where you can take a tour of their very nice Healing Space (as they call it), opened in 1999 at a total capital and building cost of £2,780,189 and costing the NHS over £2 million per annum in running costs.

The Bristol Homeopathic Hospital (BHH), part of University Hospitals Bristol NHS Foundation Trust, was recently downgraded from a city centre location to a clinic, now only sharing space in the South Bristol Community Hospital.

Decline

We've already seen the decline in homeopathy prescriptions on the NHS in England and Wales and this was examined further by Nancy K on her Evidence-Based Skepticism blog: Homeopathic harms vol. 8: Opportunity costs.

An FOIA request in 2011 by A Cuerden revealed some interesting figures for the GHH. The following charts show the number of new outpatient attendances, drawn from all over Scotland. There is certainly a decline as expected, but what is also interesting is to look at the number of return attendances — or rather the ratio of total attendances to new attendances. This is shown in the second chart, along with the trend.

GHH Outpatients

The correlation coefficient between these two sets of data is -0.75. There could be several explanations for the increasing number of return attendances: one might be that their treatments are becoming less effective over time, requiring further sessions by patients, but other interpretations might spring to mind…

But it seems it's not just us who are pondering the future of the GHH: the building could be put to some good use as Scotland's first dedicated centre for chronic pain.

A similar FOIA request about the BHH tells us it costs around £350,000 per annum to run and gives some more interesting charts:

BHH stats

It's clear where they are headed.

Questionable claims

Getting back to the claims they were making, we were not convinced that the GHH or the BHH held the necessary evidence to substantiate them, so we submitted two complaints to the ASA: one about a GHH leaflet we obtained and a number of pages on their website and another complaint about claims on the BHH website.

The GHH say they provide a wide range of therapies: "Mindfulness Based Cognitive Therapy, Heartmath, Counselling, Art and Music Therapy, Physiotherapy, Therapeutic Massage, Allergy therapy and Anthroposophic medicine and complementary therapies such as Acupuncture, Homeopathy and Mistletoe Therapy." A few of these do have some good evidence behind them; others less so.

In their homeopathy leaflet, they stated:

out-patient homeopathic consultation

in out-patients, we see as full a range of conditions as a typical GP and are happy to treat any and multiple illnesses.

some examples of the problems we treat:

dermatology such as eczema, acne, psoriasis…

gynaecology such as pms, endometriosis, menopause…

gastroenterology such as IBS, IBD…

allergies at a specialist allergy clinic

childhood problems, such as behavioural difficulties, recurrent infections…

neurology, such as headaches, neuralgias, symptoms associated with MS…

psychiatry, such as anxiety, depression…

complementary cancer care, including Iscador

rheumatology, such as fibromyalgia, symptoms associated with, RA, OA…

cfs-me

We challenged all these claims, including their claim that they see "as full a range of conditions as a typical GP and are happy to treat any and multiple illnesses".

Our complaint about their website covered many claims made on their "Homepage", "Holistic Approach to Cancer", "Holistic Approach to Depression", "Acupuncture", "Allergy Service", "Anthroposophic Medicine", "Homeopathy" and "Mistletoe therapy" pages.

The ASA passed some of the points we made straight to their Compliance Team because they were clearly in breach of the ASA's guidance. They were going to fully investigate many of the other points we raised and asked the GHH for their response. However, that seems to have changed: they have now informally resolved the case with the ASA and have agreed to amend their website to comply with the ASA's guidance. The GHH is listed today on the ASA's website as one of their informally resolved cases, listed as NHS Greater Glasgow and Clyde.

We would have liked the ASA to have produced an adjudication so we could see how the GHH tried to substantiate their claims, particularly for mistletoe therapy, Heartmath, anthroposophic medicine as well as their more general claims. However, part of the ASA's job is to prevent the public from being misled and if it can do that by informally resolving complaints and having the claims withdrawn rather than by launching a full investigation, it usually means compliance is achieved more quickly. The end result is the same: misleading claims are removed.

Changes

The GHH have already made some minor changes to their website: their "Acupuncture", "Allergy Service" and "Anthroposophic Medicine" pages all changed on 01 April. We do not believe the pages are compliant yet and will continue to monitor them, so we may make further complaints to the ASA.

We'll let you know.

Bristol

The BHH claimed:

Homeopathy is useful in the management of:

  • Rheumatology
  • Allergic conditions
  • Asthma
  • Eczema and other dermatology conditions
  • Menstrual and menopausal problems
  • Digestive and bowel problems
  • Stress and mood disorders

Because the ASA had already had a settled view on the evidence for homeopathy for these conditions, it was referred immediately to their Compliance Team to deal with. They haven't yet removed these from their website, but we'll leave it to the ASA to deal with that. We will, however, continue to monitor their website.

So, these are another two wins for us to add to the growing list — it is just unfortunate it took a complaint from us for these misleading claims to be removed.

HealthWatch help needed

HealthWatch logoOur friends at the charity HealthWatch (they are in no way connected with any NHS Healthwatch body) ran a pilot study a few years ago on the effectiveness of consumer protection laws for regulating false claims of health benefits. They found that Trading Standards took very little decisive action, and avoided using the newest and most rigorous legislation.

A much larger study is now being set up, and this will require a lot more help from volunteers. HealthWatch needs maybe 50 people to submit complaints to Trading Standards and to monitor progress over six months, using an online system.

If you would like to participate in this exciting project, please contact HealthWatch trustee This email address is being protected from spambots. You need JavaScript enabled to view it..

And finally...

Ockham Award

Thanks to all who nominated and voted for us in the Skeptic magazine's Ockham Awards for Best Skeptic Campaign 2014. And, of course, thanks to Simon Singh for getting us set up and for his continuing support.

We were honoured to be presented with the award at the QED Conference in Manchester on 12 April by Robert Llewellyn, star of Red Dwarf and Scrapheap Challenge and evangelist for electric cars.

This was the third year running we had been nominated, but we managed to see off stiff competition from the other nominees: Guerrilla Skeptcism (US), the Houston Cancer Quack (US) and the Cosmic Genome (UK).

The award now takes pride of place on our bookshelf.

07 May 2014


 

The decline of homeopathy on the NHS

Homeopathy has long been provided on the National Health Service, but is it now in terminal decline?

Updated 03 April 2014

Even though homeopathy is to some extent tolerated within the NHS and despite there being three homeopathic 'hospitals', it is clear that it is in decline. We know that these hospitals have been branching out into other areas and have even been re-branding themselves to move away from their reliance on homeopathy.

But just because it's been a part of the NHS since 1948 does not mean that homeopathy is endorsed by the NHS or the Government as being an effective treatment.

As the House of Commons Science and Technology Select Committee, after looking at the evidence and numerous submissions and after questioning scientists, homeopaths and others, stated in 2010:

In our view, the systematic reviews and meta-analyses conclusively demonstrate that homeopathic products perform no better than placebos.

And concluded:

The Government should stop allowing the funding of homeopathy on the NHS. 

A very clear, concise and evidence-based conclusion. Unfortunately, the Government replied that it would leave it up to individual Primary Care Trusts (now effectively Clinical Commissioning Groups) to decide on the provision of homeopathy in their areas.

So how has homeopathy been faring?

We can get a good idea by looking at homeopathy prescriptions in the NHS in England.

Source data

Data on homeopathy prescriptions were obtained from Prescription Cost Analyses for England provided by the Health and Social Care Information Centre, with the help of a Freedom of Information Act request. These data may not show the total cost to the NHS as some items may be available via routes other than prescription. However, we believe they give a good indication of the number of prescriptions, the costs of these prescriptions and the average cost of a prescription.

Prescription Cost Analysis from 2004–2013

These data are published annually and can be found here. Homeopathic preparations are found under British National Formulary 19.2.3

Prescription Cost Analysis from 1998–2003

These data were published by the Department of Health and are available here.

Collectively, these data chart the decline in homeopathy on the NHS in England over the last 18 years:

The decline of homeopathy in the NHS number of prescription items

The decline of homeopathy on the NHS prescription costs

The rising cost of homeopathy in the NHS

We think these pictures speak a thousand words.

In the near future, we will be looking at where one particular homeopathic hospital gets a substantial chunk of its income from.

Update

03 April 2014

The data for 2013 were released today and the charts now include the new figures.

The downward trend of the last 17 years continues, with a further drop in the number of items prescribed of 15% from 2012 to 2013.

But the cost per item is still increasing, with inflation-busting price rises of 40%, 13% and 11% from 2010 and a further 15% increase from 2012 to 2013, giving a doubling of the cost per item since 2009.

The raw data for the charts can be downloaded here.

02 April 2014


Our published successes

A summary of our published complaint successes…so far

UpheldWe have had numerous successful complaints to the Advertising Standards Authority (ASA), the Medicines and Healthcare products Regulatory Agency (MHRA) and other regulators.

New pages on our website detail these successes to date and we'll update them as we win further complaints.

Note that in all cases, it is the regulator that decides whether any complaint is valid or not and it is the regulator that assesses the complaint and decides the outcome according to the criteria laid down in their rules, regulations and laws.

We have no say in deciding these outcomes or the sanctions applied.

Note also that any decision an advertiser makes about the future of their business or how they choose to conduct it after any complaint is entirely a matter for them. All we seek is compliance with the appropriate rules, regulations and laws.

Further details of these complaints can usually be found in our News section.

We will update our results list as new complaints are published.

Advertising Standards Authority

The full list of ASA adjudications and informally resolved cases can he found here.

In summary:

  • 15 upheld adjudications
  • 4 partly upheld adjudications
  • 18 informally resolved cases
  • 85 issues investigated
  • 231 instances of CAP Code breached identified
  • 17 instances of CAP Code not breached identified
  • 65 breaches of CAP Code 3.1 Misleading advertising
  • 62 breaches of CAP Code 3.7 Substantiation (ie where the advertiser was unable to substantiate the claims made)
  • 75 breaches of the CAP Codes on medical claims

The following chart shows the various sections of the CAP Code and the number of points found to be in breach and not in breach of these sections, as identified by the ASA. It also includes the number of informally resolved cases.

 

ASA Summary

Medicines and Healthcare products Regulatory Agency

Five notices of complaints investigations have been published by the MHRA, covering some 29 sellers of homeopathy products. The full list can be found here.

Trading Standards

We have had several successes with Trading Standards but, unfortunately, outcomes are not published — unless a case ends up in court.

For example, we had successful complaints concerning a number of conferences giving advice on cancer treatments and high street Chinese herbalists making claims in their shop windows. We hope to bring you full details in the near future.

Complementary and Natural Healthcare Council

Our 100 complaints have been 'informally resolved' to the satisfaction of the CNHC, but they have published nothing about this. We will bring you more on this later.

Other regulators

We have had successes with the Health and Care Professions Council with complaints about 39 podiatrists advertising the unlicensed Marigold Therapy, but unfortunately, they have not published the outcome on their website.

22 February 2014

 


 

Bach Flower Remedies: foods, not medicines

Medicines regulator cancels product licences for non-medicines — now covered by food regulations

BachThey look like medicines: they have a licence number after all and come in a little glass bottle with a dropper and lots of detailed instructions, precautions, restrictions and warnings and even Boots, that trusted pharmacist on the high street, is in no doubt what they are:

Boots-Bach

There are a very precise 38 'remedies' in the set of original Bach Flower Remedies, all made from different flowers, invented in the 1930s by Dr Edward Bach (pronounced 'Batch'), a medical doctor who studied at University College Hospital, London. However, it wasn't his medical training that led him to come up with these flower remedies. He was also a homeopath, working for some time at the then Royal London Homeopathic Hospital, and apparently believed that:

…early morning sunlight passing through dew-drops on flower petals transferred the healing power of the flower onto the water.

Exactly what healing power of the flower he was referring to is not clear but the remedies were:

…intuitively derived and based on his perceived psychic connections to the plants

He gave them all their own little description, like this one for Pine:

Pine

You feel guilty or blame yourself.

“For those who blame themselves. Even when successful they think they could have done better, and are never satisfied with the decisions they make. Would this remedy help me to stop blaming myself for everything?”

These have been used as indications of what 'problem' each product is supposed to address.

Manufactured

Bach Flower Remedies are made by soaking flowers in water and exposing them to full sunlight for three hours or by boiling them in water (and left to cool, outdoors of course). They are then diluted in "40% proof" [sic] brandy, diluted further with grape alcohol and then bottled. The final product typically contains 27% by volume of alcohol.

The most well known one is, of course, Rescue Remedy® (a combination of five different flower remedies), used by many to calm their nerves in times of stress, or as the manufacturer, Nelsons, puts it:

…provide comfort and reassurance for daily stressful situations.

There are even kits available such as the Emotional Eating Kit — and where would they be without their celebrity endorsements?

There are now over 50 producers of flower remedies in the UK, but Nelsons is probably the most well-known one, selling products under the Bach Original Flower Remedies brand name with their trade markedBach1®logo.

The 'remedies' are divided into seven categories and have been given new names in recent years:

Old nameNew name
Fear → Face your fears
Uncertainty → Know your own mind
Insufficient Interest in Present Circumstances → Live the day
Loneliness → Reach out to others
Oversensitivity to influences and ideas → Stand your ground
Despondency and Despair → Find joy and hope

The newer ones are even woollier than the old ones, but maybe the shift was to move them away from sounding too 'therapeutic'?

Bach finalised his set of 38 remedies in 1935. He died in 1936.

Do they work?

There is little doubt that someone who takes Flower Remedies may well believe they have an effect, but maybe there are placebo effects at play. What does the scientific evidence say?

There have been a few studies done:

A randomized, double-blind, placebo-controlled trial of a Bach Flower Remedy

It is concluded that ‘Five Flower Remedy’ had no specific effects in treating anxiety under these trial conditions.

Efficacy of Bach-flower remedies in test anxiety: a double-blind, placebo-controlled, randomized trial with partial crossover.

We conclude that Bach-flower remedies are an effective placebo for test anxiety and do not have a specific effect.

Healing With Bach® Flower Essences: Testing a Complementary Therapy

The results suggest that BFE Rescue Remedy may be effective in reducing high levels of situational anxiety.

This last conclusion might come as a surprise, particularly since the trial was double-blinded, randomised and controlled. However, Prof Ernst has roundly criticised this trial as 'data dredging', saying that the positive result is "clearly based on a post hoc analysis".

It is clear there is no good reason to think Flower Remedies have any specific effects and therefore should not be considered medicines.

The Advertising Standards Authority are clear on what they would allow in advertising:

This therapy is described as a “therapeutic system that uses specially prepared plant infusions to balance physical and emotional disturbance”. Normally, flower ‘remedies’ are ingested to provide ‘energy’ to overcome negative thoughts. CAP is unaware of a relevant trade body or regulatory organisation. The method seems to lack scientific rigour and is supported mainly by anecdotal reports. In the absence of more compelling evidence, marketers are advised not to make claims for the efficacy of this treatment (Rule 12.1).

Legal status

We've mentioned Product Licences of Right (PLR) before in relation to homeopathic 'medicines', but the same applies to Bach Flower Remedies: they were given a free pass over 40 years ago and allocated a PLR licence number. Like homeopathy, the manufacturers have not had to provide any evidence whatsoever for claims made for these products. It is an anachronism that can only mislead the public.

The MHRA launched an informal consultation in January 2011 to look at some of these issues, hoping to use the upcoming review of the Medicines regulations to scrap the PLR scheme for all products:

The MHRA considers that it would be undesirable to use the current review of the Medicines Act and associated legislation to further perpetuate the existence of PLRs. This kind of licence, by its nature is envisaged as a pragmatic, temporary arrangement until products are reviewed and, where appropriate, moved to an ongoing regulatory scheme where they meet the relevant standards. It is highly desirable that product licensing schemes should reflect current regulatory standards and not represent a hangover provision from a number of decades ago. The review of the Medicines Act provides a suitable opportunity to bring the PLR arrangement to a close. This would also have the benefit for homeopathic products of achieving improved consistency of regulatory provision for labelling and advertising. This will better enable MHRA to regulate the market for these products. Improved patient information will benefit the consumer and facilitate informed choice.

In considering Flower Remedies specifically, they said:

A number of PLRs are for Bach flower remedies. MHRA intends to take the position, against the criteria set down in European legislation, that such products should normally no longer be regulated as medicines. Indeed there are many Bach flower remedies on the UK market, (and we understand on the markets of other EU Member States) that are legally supplied under other regulatory categories, such as food supplements. This change would represent a useful simplification and create a more level playing field for suppliers of this kind of product.

This didn't happen: there was no mention of this in the consolidated medicines regulations.

However, the MHRA have not been idle. There may well have been lobbying from Flower Remedy manufacturers — we suspect there was, but we don't yet know. But as a result of an FOIA request we submitted a few months ago, we now know that Bach Flower Remedies are no longer classed as medicines and have been relegated to being just food.

We asked the MHRA:

Question 4: Can you confirm that you still agree with your proposal of January 2011 that Bach flower remedies no longer be regulated as medicinal products? If so, what are the timescales for this?

Response 4: The MHRA contacted Nelsons on 29 July 2013 to advise them that all Product Licenses of Right for Bach flower remedies would be cancelled and that products quoting Product License of Right reference numbers and that include homeopathic/medicinal references on their packaging must be cleared from warehouses within 6 months and must not be put on the market after 28 January 2014. However, such products already on the market may be sold through and will not need to be recalled.

So, as of today, Bach Flower Remedies are not allowed to be placed on the market with a PLR licence number and they must have no medicinal or homeopathic references. That includes therapeutic indications, but exactly what that means isn't too clear.

We should now (or at least after products have cleared the supply chain) no longer see Bach Flower products with misleading licence numbers and they should no longer have homeopathic/medicinal references in their packaging or their advertising.

Just foodstuffs

Since they are no longer medicines, they are just foods now and health and nutrition claims fall within the remit of EU Directive 1924/2006, as enforced by European Food Standards Agency (EFSA). In the UK, advertising claims under EFSA regulations are regulated by the Advertising Standards Authority.

So, if advertisers of Bach Flower Remedies use the same claims as they have in the past, are they likely to be EFSA-compliant?

Given the lack of evidence, it would seem unlikely: but it's very easy to check the EFSA Register on nutrition and health claims. The Bach Flower products are, of course, mostly alcohol, but even if the decoctions of the various flowers are in sufficient quantities to be considered ingredients, it would be easy to check the EFSA register for all 38.

But there is no need.

Foodstuffs that contain more than 1.2% by volume of alcohol are singled out specifically in the EFSA rules:

Beverages containing more than 1,2 % by volume of alcohol shall not bear:
(a) health claims;
(b) nutrition claims, other than those which refer to a reduction in the alcohol or energy content.

So, because Flower Remedies contain little more than alcohol, they are not allowed any health claims whatsoever. Whether the flower ingredients themselves warranted any authorised health claims is entirely moot.

But are the words in the category names implied health claims? Is the woolly description for each product a health claim? Can they still be called 'remedies'? What about 'Rescue Remedy'?

A German court gives us the answer.

In court

In Germany, there is no equivalent PLR scheme and in August 2013, a regional court in Bielefeld, Germany confirmed that Bach Flower products are indeed covered by the EFSA regulations (HCVO in German) and confirmed that medicinal claims were not allowed.

This was a case brought by a trade association against a pharmacist who was selling Bach Flower products online. The association claimed unfair competitor behaviour from the pharmacist by falsely advertising both "RESCUE® - The original Bach® Flower mix" and "original Bach Flower essences" in general with health claims. Note the slightly different product names used in Germany — they don't include the word 'remedy', although this is sometimes seen on Bach products in Germany directly imported from abroad.

The defending pharmacist was supported in their case by their supplier for these products, that in the court's judgement was referred to as "the German subsidiary of B. & Co. Ltd. from England", as "sister company of B. Ltd. - the producer of the original Bach Flower products", and as "the German sales branch for all their respective products". We believe this means that they were supported by Nelson GmbH in Hamburg, the German distribution subsidiary of A Nelson & Co Limited, the multi-million pound UK company that produces Nelsons homeopathic products.

The accused argued that they didn't make any actual health claims but only referred to "potential improvements in general well-being". The court wouldn't have any of this, as they said the advertisement clearly refers to specific circumstances of life where the Flower products "could be" helpful, and the HCVO regulation asks for a broad interpretation of "health claims" to make sure consumers are protected: "even unspecific indications with reference to health are to be considered health-related indications under the HCVO".

When the supplier argued to support the accused, they suggested their ordinary customer would not consider their claims as health-specific (which would require scientific evidence), but only expect that "those products were designed for and would have some impact on specific everyday emotional states". "These expectations are fulfilled by the Bach Flower products", they continued, "be it because of their energetic properties as ascribed to them by Edward Bach, or because of the reminder or suggestive function that accompanies their consumption." They would appear to be simply saying the products provide placebo effects and no more!

But the court ruled these were claims towards psychological support and hence qualified as health claims no matter how unspecific the manufacturer thinks the claims were.

So it does appear that even the woolly claims are not allowed, and the pharmacist was told to stop making them. If the pharmacist continues to make the stated claims, they can fine him up to €250,000 cash or send him to jail for up to two years if he doesn't pay the fine. That's worth repeating: up to €250,000 in fines or up to two years in jail.

The pharmacist has to pay for the trial costs, and the Bach Flower company, who supported him in his defence, has to cover their own costs.

How much this has cost the pharmacist and the German and UK Bach Flower companies we cannot know. Because of the importance of the case, we suspect it was fought hard. What we can do is look at the finances of the UK company:

BFRfinancialsData from Company Check

The future

It's good to see the MHRA finally catch up and cancel the PLRs for these non-medicines — even if it has taken 40 years — and we urge them to do the same for homeopathy PLR products so that the public are not misled into thinking they are medicines.

However, now Bach Flower products are just foods, we look forward to manufacturers and all others who supply and advertise these products to fully comply with the EFSA regulations, enabling the public to make fully informed choices.

We believe the German ruling sets a precedent that is binding in the UK, but if we have to test the various claims for Bach Flower Remedies with a complaint to the ASA, we will.

Acknowledgements

Thanks to Sven Rudloff for help in understanding the German ruling and Aribert Deckers for bringing it to our attention in the first place.

29 January 2014

Update

02 February 2014

The Advertising Standards Authority has now updated its guidance on Therapies: Bach and other flower remedies:

This section should be read in conjunction with the entry on ‘Therapies: General’.

Bach flower remedies are described as “a system of 38 Flower Remedies to help mankind achieve joy and happiness”. CAP understands that at the time the Medicines Act (1971) was implemented, Product Licences of Right (PLRs) were issued to all medicines, including homeopathic remedies, and that a number of PLRs were granted for Bach flower remedies.

In January 2014 the MHRA took the decision that Bach flower remedies would no longer be regulated as medicines but instead be classified as foods. Any health or nutrition claims made for foods must be made in accordance with those claims permitted on the EU Register and Annex.  CAP understands that some Bach flower remedies contain levels of alcohol which would preclude them from bearing health claims altogether (Rule 18.17).  While it may be possible for a flower remedy to carry a nutrition claim, the nutrition claims permitted for products containing alcohol are limited.

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