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We can't win them all...

Our critics commonly allege that either we are the puppets of the ASA or we have the ASA in our pockets. The latest adjudication on one of our complaints gives the lie to that.

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:

  • asthma
  • colic
  • prolonged crying
  • sleeping and feeding problems
  • breathing difficulties
  • hyperactivity
  • bedwetting
  • 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?

Nerve interference

Daniel David PalmerBut 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.

Primary claims

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. 

What the public thinks

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):

  • Asthma 491 (57.49%)
  • Digestive disorders 461 (53.98%)
  • Infant colic 539 (63.11%)
  • Menstrual pains 542 (63.46%)
  • Sciatica 826 (96.72%)

26.58% believed they could treat the following range of conditions (some are musculoskeletal, but the majority are not):

  • Arthritis
  • Biomechanical disorders
  • Growing pains
  • Cervicogenic H/A
  • Epilepsy
  • Carpal tunnel
  • Pregnancy care – pre and post natal problems
  • Neurodevelopmental problems in children, ADD, ADDH, COCD, dyslexia, dysproxia, nocturia, podiatric conditions, bed wetting, growth, behaviour, developmental
  • Dyspraxia
  • ME, FMS, MS
  • Allergies/intolerances including hay fever, eczema
  • Scoliosis and Kyphosis
  • Menstrual irregularities
  • Disc, whiplash
  • RPT
  • RSI
  • TMJ
  • SPD
  • Plagiocephely
  • Tinnitus, vertigo, dizziness, balance disorders, visual problems
  • Fibromyalgia
  • Enuresis
  • Chronic upper respiratory infection
  • Palliative relief for incurable conditions such as osteoporosis, cancer, multiple sclerosis
  • Depression
  • Post operative
  • Hypertension, stress, chronic fatigue syndrome
  • Vertigo
  • Parkinson’s
  • Stroke
  • Immune system
  • Correct nervous system dysfunction to enable the body to heal itself – do not treat specific medical conditions
  • Promotion of optional health – wellbeing/preventative care

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.

Setting the precedent

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.

Successes

As a result of this adjudication, we have updated our Results page. The following chart shows our ASA record so far:

ASA Summary - 12 November 2014

Attributions

"LondonAmbu" by gwire - Flickr.com - image description page. Licensed under CC BY 2.0 via Wikimedia Commons.

"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


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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