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And cancer. And depression. And Dengue Fever, Japanese Encephalitis, Yellow Fever, hayfever, allergies, fungal infections, Crohn's disease, ADHD, IBS…
The list of conditions this device from Bicom can treat is long. With that and their cheap, 48-hour home blood test kit that only requires a drop of your blood, it's a wonder every hospital doesn't have one, particularly since Bicom claim many of these diseases have been treated successfully for over 30 years in humans. It must be a well-kept secret.
A well-kept secret that Bicom tells everyone about on their website. On multiple websites in fact. On the World-Wide Web. And trains people to use it in the twelve UK training courses they have scheduled for this year. Maybe we all need to tell our GP about it.
But maybe doctors already know, but don't tell you for some reason?
Alternatively, there may be very good reasons why doctors don't tell you about this miraculous machine and the blood tests.
We came across an advert for the Bicom device and the home blood test kits in the September 2014 issue of What Doctors Don’t Tell You (WDDTY).
We wondered whether the advertiser would be able to substantiate the claims made in the ad and on his websites: www.reson8.uk.com and www.blood-test.co.uk related to the ad and another one owned by the same company, www.ebolatreatments.com so we submitted a complaint to the Advertising Standards Authority.
Their adjudication is published today, upheld on all six points.
The ad in WDDTY said:
WHAT DOCTORS CAN'T TELL YOU We can, with Bioresonance, treat the cause and not the symptoms by working at cellular level! Allergy Food Intolerance Bacterial and fungal infections Virus and toxins The above items and many more have been treated successfully for over 30 years in humans and over 10 years with animals. Many experience complete recovery without the side effects of drugs…48HR TEST RESULT Can Save Your Life! Try our Home BLOOD TEST Kits Blood test from own home Easy to use kit 48 hour returned results Only need a drop of blood (unlike other tests) Allergies, Parasites, Toxins, Virus's [sic] and many other tests available.
For the www.reson8.uk.com website, the ASA quoted some of the claims and said:
"Disorders Hayfever & Allergies Cancer Depression Smoking Weight Gain Electronic Smog Asthma Digestive Skin problems Gastro-intestinal diseases Auto Immune diseases Infectious diseases Neurological disorders Dental Pain Sports Injury Migraine". A video on the website gave details about how the treatment worked and featured individuals, some of which were introduced as medical professionals, talking about how the treatment had helped a number of conditions including gut problems, irritable bowel syndrome, Crohn's disease, allergies, neurodermatitis or ADHD and dental purposes. On a page, entitled "Bio-resonance treatment options for Ebola", text stated, "BICOM bioresonance therapy has been able to help many patients with just three or four sessions. Could this proven method of testing and treatment help people with Ebola and disable the virus early? Lets [sic] hope so…
Claims on www.blood-test.co.uk stated:
Home Blood Testing… Allergy testing in the UK has never been easier…During the testing, the frequencies of most known substances are measured against your blood sample. Upon detection, frequency patterns that match emit a "resonance" which is then recorded. The substances which contribute to your stress, or are likely to cause stress, or that may have caused stress in the past are rendered identifiable…For a fast, affordable, reliable and convenient home blood test service you need look no further than Blood Test UK…Order a free allergy test kit now
But perhaps most worryingly, on www.ebolatreatments.com:
Ebola Treatments and Testing: Give hope to those who need it most without medication! Bioresonance has not been tested or verified with the Ebola Virus, however it has been very successful with other hemorrhagic virus's [sic]. It is hoped that medical institutions in affected areas can apply our treatment protocols listed on this site and register their successful outcomes. We only use Class 2A medical devices such as the Bicom Optima which also is CE approved.
Further text on a page entitled Vaccine stated:
Ebola Vaccine No proven vaccine currently exists but…A bioresonance company in Australia has had some success preparing travellers against other pathogens like Bird Flu, Dengue, Japanese Encephalitis, Yellow Fever etc, in fact many pathogens can be used in a single tablet. The pathogenic frequencies are inverted and stored in pill form and taken during the trip.
Just to repeat those last few words:
The pathogenic frequencies are inverted and stored in pill form and taken during the trip.
You can see why we were concerned about these adverts — and we weren't the only ones. Someone else also complained, but of course, due to ASA confidentiality, we have no idea who that was.
The issues identified by the ASA were mostly concerned about whether the advertiser could substantiate the claims and whether the ads 'discouraged essential treatment for conditions for which medical supervision should be sought.' Like Ebola.
When asked by the ASA to substantiate the claims made, the advertiser, Bicom UK LLP, said:
…the claims were carefully worded, not making reference to the effectiveness of the treatment, and a disclaimer on their websites encouraged people to visit their doctor if they had a serious condition. They said that the listed disorders were being treated on a daily basis by 15,000 practitioners. They provided a 2009 press release following a German court case, which cited a decision not to impose an injunction on Bicom's claim to treat allergies, and an academic paper, which explored the electromagnetic effects on humans.
Needless to say, this 'evidence' did not satisfy the ASA's high standards. To understand how the ASA came to their decision to uphold all six points, please read their assessment of this 'evidence'.
The ASA decided the ads breached the CAP Code on a total of 18 counts and the advertiser was told:
The ads must not appear in their current form. We told Bicom to ensure that they held adequate substantiation for the efficacy claims made in their advertising and did not offer treatment or discourage essential treatment for conditions for which medical supervision should be sought.
Since the ad included claims about cancer, the ASA have referred the matter to Trading Standards (TS) for further investigation. It should be noted that TS have had a lot of success in prosecuting those making cancer claims. See Jo Brodie's blog post: Cancer Act 1939 convictions in the UK for full details.
We noticed that Bicom had stated that:
We only use Class 2A medical devices such as the Bicom Optima which also is CE approved.
This is a technical point about compliance with the EU Medical Devices Directive (MDD) 93/42/EEC and CE marking of a device. This CE marking is what is seen on many household items these days from electrical goods to toys and is a declaration by manufacturer or EU importer that the product meets the essential requirements of all applicable EU Directives, such as safety. For medical devices this is the MDD and there are several Classes, depending on the product and its function. Bicom are claiming their device is Class IIa, but we doubted this was correct and that they could substantiate this. The ASA took this up and told us:
We requested that they provided evidence to substantiate the claims “Class 2a” and “CE approved” appearing on www.ebolattreatments.com. Further to this, the advertiser provided some documentation to substantiate the claims. As we were not initially certain were the certifications were legitimate, we contacted the Medical Healthcare Regulatory Agency (MHRA) who confirmed that they were and, therefore, that the evidence did substantiate the claims.
However, the MHRA have decided to investigate the advertiser on the basis that they may not be using the device in the certified way. Unfortunately, due to statutory confidentiality restrictions, the MHRA will not be able to provide any further information about their investigation or update us on its progress.
Although the MHRA are investigating, this highlights two problems: how such a device ever came to be classified under IIa and the secrecy under which the MHRA operate.
Dealing with the first point, under the MDD, a manufacturer has to provide a dossier to a Notified Body to check everything is in order and it looks like the MHRA have checked this and decided the paper work was all present and correct. We believe there is a serious problem with how this works and the ease with which devices can appear to be compliant with the MDD with no evidence that they actually work. Possibly the worst example of this we have found was ear candles marked as Class I medical devices. This was a few years ago and the MHRA dealt with it, but this brings us on to the second issue: that of MHRA secrecy.
We don't know the details in this case, but the MHRA sometimes cite Article 20 of the MDD on confidentiality:
Without prejudice to the existing national provisions and practices on medical confidentiality, Member States shall ensure that all the Parties involved in the application of this Directive are bound to observe confidentiality with regard to all information obtained in carrying out their tasks.
There are certainly arguments to be made about treating possibly commercially sensitive information that the MHRA obtains from a manufacturer in the course of an investigation, but we believe that this cannot be interpreted as covering all information relating to a complaint or investigation, including whether a complaint had any merit, whether the MHRA investigated, what they found and concluded and what action they took or sanctions they imposed in order to fulfil their duty to enforce the MDD and protect the public.
This is certainly something we will return to at a later date.
We didn't say much about it at the time, but we had also submitted a complaint about another advert in the September 2014 issue of What Doctors Don't Tell You. This one was informally resolved by the ASA and only the advertiser's name and brief details were published on the ASA's website on 5 November 2014.
The products being advertised were various models of sauna, with these claims:
Japanese studies have shown that Far Infrared Saunas are beneficial for arthritis, fibromyalgia, chronic fatigue, diabetes, insomnia, stress, psoriasis, chronic pain and can aid detoxification, weight loss, and fitness.
As with the Bicom WDDTY ad above, we also looked at this advertiser's website www.firzone.co.uk. We included some examples of the claims made on the website in our complaint, including:
Its application is suitable for slimming, detoxification, complementary cancer therapy (hyperthermia), cardio vascular fitness, treatment of aches & pains, healing, or as a pre massage treatment to relax muscles and increase blood flow.
Health Benefits of Infrared Sauna
- Treat muscular aches and & sprains
- Improve circulation
- Promote weight loss
- Have healthy looking radiant skin
- Relax mind and body
- Enhance detoxification processes
- Improve cardiovascular conditioning and fitness levels
- Treatment of aches and pains
- General fitness
We don't know if the advertiser provided the evidence they mentioned in the ad or any other evidence they might have had, or whether they just agreed to remove the claims the ASA were unhappy about. All we know is that they removed these claims from their website: it's always interesting to see how an advertiser tries to substantiate claims, but removing the claims is still a good result.
Because of the cancer claims, we brought this to the attention of Trading Standards (via the Citizens Advice Bureau's webform) who investigated. Once the advertiser had removed the claims, TS closed the case.
We found other adverts in What Doctors Don't Tell You — and on those advertisers' websites — we were concerned about and submitted comprehensive complaints about those as well. They are still being investigated by the ASA, but we'll bring you the details when the outcomes are published.
It is however, very disappointing, despite the large number of previous adjudications and informally resolved cases about adverts published in WDDTY, that its publishers continue to carry ads making misleading claims and that some of their advertisers have been found to be publishing ads that are not only misleading, but are also irresponsible.
28 January 2015
The report recommends that:
NHS Lanarkshire should cease new referrals of Lanarkshire residents to the CIC as of 31 March 2015 on the basis of the lack of clinical effectiveness evidence for homoeopathy, and other health interventions noted in this paper, delivered by the CIC.
It is expected that the Board will accept its recommendations this afternoon at their extraordinary meeting.
[Updated at 14:55] NHS Lanarkshire have just announced their Board's decision to accept the report's recommendation to stop all referrals to the Glasgow Homeopathic Hospital after next March.
Their Director of Public Health and Health Policy, Dr Harpreet Kohli, and his team (which included the homeopath and Lead Clinician at the GHH, Dr Bob Leckridge) conducted a thorough review:
In reaching a consensus on recommendations for the future of the homoeopathy service, the Group considered all the evidence gathered during the course of the review and also took account of A Healthier Future and NHS Scotland’s Strategy Ambitions.
Following full consideration and deliberation, the Group concluded that, whilst the subjective evidence from patients expressing benefit from and support for the service was strong, there was clear and unambiguous evidence that homoeopathy and associated services were lacking in terms of therapeutic benefit. In addition there was a strength of clinical opinion across the UK that homeopathic treatments should not be provided by the NHS. On that basis, the Group’s view was not to recommend referral to the CIC, which offers homoeopathy and associated services.
They conducted a literature review for the treatments provided by the GHH, concluding:
The literature reviewed in relation to homoeopathic care for various conditions including fibromyalgia (coping with pain and depression), prevention and treatment of influenza and influenza-like illness, therapy for preventing or treating the adverse effects of cancer treatment, attention deficit/hyperactivity disorder (ADHD) and insomnia, found insufficient or no evidence to support homoeopathy.
Mindfulness-based cognitive therapy
Reviews of MBCT for the treatment of various conditions including fibromyalgia, chronic diseases, stress reduction for breast cancer, chronic fatigue syndrome and anxiety and depression concluded that there is some evidence that MBCT improves psychological health in breast cancer patients and improves mental health and symptom management in patients with chronic disease.
No systematic reviews or meta-analyses were identified for HeartMath.
Mistletoe for cancer symptoms
Reviews of mistletoe extracts for cancer patients had differing results – a Cochrane Review concluded that there was insufficient evidence while two other studies concluded that mistletoe extract may be associated with better survival and that there was some evidence to support the effects on quality of life. Limitations of the studies were highlighted however and a caveat added to treat the findings with caution.
Music and movement therapy
Some reviews of music and movement therapy, while concluding that listening to music may help to reduce anxiety, reduce pain and respiratory rate and have a beneficial effect on the quality of life for people in end-of-life care, did not have strong evidence. The therapy appeared to have benefit for patients with Parkinson’s disease but concluded that future studies should include greater numbers of patients.
For homeopathy, their Homeopathy Review Group built on the work carried out by the House of Commons Science and Technology Select Committee in their Evidence Check on homeopathy, looking at appropriate evidence published since then, up to October 2014. They found that the report's conclusions were unaffected by any new evidence.
As well as surveying existing patients and GPs, and visiting the GHH and its outreach clinics in Coatbridge and Carluke, a public consultation was also carried out by NHS Lanarkshire — the results of that have also just been published. Nearly 6,000 responses were received with the majority in favour of continuing to refer to the GHH. Our response to the consultation can be read here.
However, the report notes that there had been a concerted campaign to 'Save the Glasgow Homeopathic Hospital', including an online petition, instigated by homeopath Louise Mclean of the Homeopathy Heals website. It also noted that an analysis showed most signers were from outwith Lanarkshire. We have been made aware that Mclean has called for supporters intending to demonstrate outside the building where this afternoon's meeting is being held and to write to MSPs and the Scottish Health Minister to complain.
Of the responses expressing support, the main themes were:
Of the responses expressing no support, the main themes were:
Despite the praise for the services (mostly from those not actually using them), we commend NHS Lanarkshire for going with the best evidence rather than popularity in deciding what treatments to provide.
Patients will not be left high and dry by this decision. New referrals will cease on 30 March 2015, but those currently attending the GHH or the two outreach clinics will continue to receive the treatments.
New patients from April will be able to receive a wide range of conventional, evidence-based, treatments such as those provided by psychosocial services, the addictions service and a number of condition-specific services already provided by NHS Lanarkshire.
Overall, this is a damning indictment of the services provided by the GHH. It can only be an embarrassment to NHS Greater Glasgow and Clyde to have a 'hospital' that is providing treatments for which their Lanarkshire colleagues have concluded there is no good evidence.
After the closure of its pharmacy in 2011, the withdrawal of referrals from NHS Highland in 2010 and from NHS Lothian in 2013 and the decline in outpatient attendances over the last ten years, this must surely be the final nail in the coffin of the Glasgow Homeopathic Hospital.
09 December 2014
There seems to be widespread use of the term ‘primary healthcare/contact practitioner/profession/provider’ by chiropractors. Some of the many variations include:
Chiropractic is a primary health-care profession that specialises in the diagnosis, treatment and overall management of conditions that are due to problems with the joints, ligaments, tendons and nerves, especially related to the spine. (Source)
The perception of Chiropractic is often limited to the treatment of back, or neck pain, but as Primary Healthcare Providers Chiropractors are consulted about a whole range of conditions. (Source)
Chiropractic is a primary health care profession which emphasises the inherent recuperative power of the human body to heal itself without the use of drugs or surgery. (Source)
As primary healthcare practitioners we are perfectly situated to help you within our areas of expertise and point you towards other specialists as appropriate. (Source)
Chiropractic is the third largest primary health care profession in the world after medicine and dentistry. (Source)
Chiropractors are primary contact, primary healthcare practitioners – as such, no form of referral is required as a prerequisite to visit a chiropractor. (Source)
A Chiropractor is trained to diagnose and treat your condition and will refer you to another healthcare professional if necessary. (Source)
Chiropractors are neuro-musculoskeletal specialists, trained as primary healthcare practitioners – meaning that no matter what the ailment, each patient will receive the appropriate care or referral as necessary. (Source)
There are some common themes in these, but we were concerned that members of the public might see chiropractors as a first port of call for a variety of medical conditions, rather than their GP.
Why would we think this might be a problem? We already know the evidence for chiropractic spinal manipulations is scant, even for their 'trade mark' condition of non-specific lower back pain (LBP). And it's not without specific and non-specific harms either, of course.
But maybe it wouldn't be a great problem if their advertising was restricted to a few musculoskeletal conditions such as LBP and were fully informed?
There are problems, however.
For example, one website claims:
Chiropractic care can also help children with:
- prolonged crying
- sleeping and feeding problems
- breathing difficulties
- frequent infections especially in the ears
These are some of the more common musculo-skeletal conditions which nearly everyone suffers from at some time in their life. Many conditions start as minor ailments which can progress to more severe and longer lasting episodes of pain if left untreated or ignored. Our goal is to get you out of pain as soon as possible, whilst improving joint movement. Failure to restore normal function usually means that any pain relief is temporary.
After the British Chiropractic Association (BCA) dropped their libel case against Simon Singh for an article he wrote in 2008 for the Guardian in which he highlighted chiropractors making claims for many of these same childhood conditions, it's surprising to see them still being made.
Many websites were changed as a result of this and my 524 complaints submitted to the statutory regulator, the General Chiropractic Council; this resulted in the ASA revising their guidance on claims made by chiropractors — and that guidance certainly doesn't include asthma, colic, bed-wetting etc!
So why are such claims still being made? And, more importantly, what is a member of the public supposed to think when they see claims like these?
But for some chiropractors (certainly not all), claims like these are perfectly acceptable and, indeed, an integral and utterly necessary and inescapable part of chiropractic 'philosophy' as invented by DD Palmer. Some are taught that 'dysfunction' of vertebrae in the spine can cause 'nerve interference' that in turn can cause all sorts of medical problems and that what's needed is a chiropractic adjustment to correct the displacement and so allow proper nerve flow, permitting the body's vital force to heal itself. There is, of course, no good evidence that this dysfunction — or vertebral subluxation complex (VSC) in their parlance — even exists or that it results in any pressure on the nerves never mind that any adjustment of the spine can somehow alleviate anything.
So, even claims such as those above are seen as musculoskeletal issues that chiropractic can treat — as that chiropractor states.
We also are aware of concerns about the attitude of some chiropractors to the medical profession in general and things like vaccinations in particular. Prof Ernst warns of such non-evidence based attitudes in the US, but it doesn't take much effort to find similar attitudes in the UK.
We saw the use of the terms incorporating 'primary' as potentially misleading to the general public, particularly those not familiar with chiropractic or health and medicine in general, so we submitted a complaint to the ASA.
We argued that the various phrases used by chiropractors that referred to 'primary healthcare'. We included a definition by the World Health Organisation. In its Declaration of Alma-Ata, the World Health Organisation defined primary care as:
…essential health care based on practical, scientifically sound and socially acceptable methods and technology made universally accessible to individuals and families in the community…It forms an integral part both of the country's health system, of which it is the central function and main focus, and of the overall social and economic development of the community. It is the first level of contact of individuals, the family and community with the national health system bringing health care as close as possible to where people live and work, and constitutes the first element of a continuing health care process.
The Health and Social Care Information Centre (HSCIC) introduce Primary Care:
As many people's first point of contact with the NHS, around 90 per cent of patient interaction is with primary care services. In addition to GP practices, primary care covers dental practices, community pharmacies and high street optometrists.
The Department of Health defines the essential attributes of Primary Care as:
- co-ordinates the care of the many people with multiple, complex health needs
- delivers care closer to people, increasing convenience, especially in areas remote from hospitals.
- is a first point of contact for patients to facilitate the early detection of illness, and thereby improves outcomes.
- provides a long-term perspective to support disease prevention and healthy lifestyles.
- provides more cost-effective treatment for minor illnesses and injuries than hospitals
The primary care systems for the 21st century are built on the foundations of:
- multi-disciplinary teams of healthcare professionals trained for family medicine
- suitable facilities and infrastructure, integrating digital healthcare, to provide a range of access options and support dispersed populations
- clinical pathways for consistent and effective care, with referral processes for specialist consultations
- information systems including electronic patient records to optimise clinical activity
We did not see chiropractic as fitting any of these criteria and therefore believed any association with 'primary healthcare' to be misleading.
But it's not what we think that's important. We don't make the rules or enforce them. In this case, because this was all about adverts on the websites of chiropractors, we submitted a complaint to the Advertising Standards Authority (ASA), providing them with quotes from 12 websites and inviting them to choose whichever they felt best covered the issues.
They considered our complaint and, as we had suggested, chose just to investigate the wording on one website, Kingsbridge Chiropractic Clinic. They considered two points and decided that there had been no breach of the advertising code. However, we don't think the two points fully covered the issues we complained about.
The ASA's adjudication is published today.
The ASA decided:
The ASA understood that the term "primary healthcare practitioners" was not protected and did not have a fixed definition; although we acknowledged that the term "primary healthcare" was generally used in the health sector to refer to the first point of contact for the public to access healthcare in the community, such as GPs, dentists and optometrists. We considered that the average consumer was likely to have an awareness that chiropractic focussed on musculoskeletal conditions and considered that, in the context of the ad, consumers were likely to understand the term "primary healthcare practitioners" to refer to their ability to access chiropractic treatment directly, without referral. We did not consider the term implied that chiropractors held general medical qualifications, that they were able to treat a wide variety of conditions (beyond musculoskeletal conditions) or that they could act as a primary contact for those with general health concerns. We also did not consider the term was likely to discourage essential treatment for conditions for which medical supervision should be sought. We therefore concluded the claim did not breach the Code.
Their assessment rested on the assumption that "average consumer was likely to have an awareness that chiropractic focussed on musculoskeletal conditions". The ASA are generally good at understanding how a member of the general public would regard adverts and what they would take wording to mean. However, we think that the public are not as aware as the ASA assume.
We cited research conducted by the General Chiropractic Council in 2012: Research into Patients Views and Expectations of Chiropractic Care 2012 that concluded:
The majority of patients in the national survey rated their knowledge of chiropractic prior to treatment towards the lower end of the scale i.e. ‘I knew very little’.
We also cited an older study: Consulting the Profession: A Survey of UK Chiropractors, 2004. The GCC has asked chiropractors what they treated: as well as musculoskeletal conditions, other conditions included (number and percentage of chiropractors who believe this can be treated or managed by chiropractors):
26.58% believed they could treat the following range of conditions (some are musculoskeletal, but the majority are not):
We believe this amply demonstrates that chiropractors represent themselves are treating a lot more than just "musculoskeletal conditions".
However, the ASA was not convinced by our arguments and did not uphold the complaint.
Although we didn't win the adjudication, we now have the ASA's view on what an average member of the public would be likely to understand by the phrase "primary healthcare practitioner":
…consumers were likely to understand the term "primary healthcare practitioners" to refer to their ability to access chiropractic treatment directly, without referral.
This now gives us something concrete to work on and, no doubt, we will refer to this in future complaints.
As a result of this adjudication, we have updated our Results page. The following chart shows our ASA record so far:
"Daniel David Palmer" by Unknown - http://www.palmer.edu/PFCH/hometowngallery/3-family-dd.jpg. Licensed under Public domain via Wikimedia Commons.
12 November 2014
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 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.
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…
More worrying were the claims about cancer.
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.
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.
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:
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.
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.
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.
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.
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.
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:
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.
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 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.
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.
The 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.
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.
At 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:
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?
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.
The Too Long; Did Not Read version…
07 December 2014
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.
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.
In terms of the rental and other costs:
We 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.
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 Foot, hypnotherapy, western 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:
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!
But back to the acupuncture clinic.
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.
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.
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.
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.
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.
20 August 2014
We 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.
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.
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.
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:
It's clear where they are headed.
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…
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.
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.
The BHH claimed:
Homeopathy is useful in the management of:
- Allergic conditions
- 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.
Our 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.
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.
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