Challenging misleading healthcare claims

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WDDTY #2 - The Second Wave

Another two informally resolved cases and our first adjudication against an advert in What Doctors Don't Tell You.

That now makes four informally resolved cases for seven adverts and one adjudication upheld against two ads.

The latest two cases the Advertising Standards Authority (ASA) were able to informally resolve with the advertiser without having to resort to a formal investigation were published last week. These were against four ads by the General Naturopathic Council Ltd and one ad by Asthma Care Kent.

gnc-1General Naturopathic Council

The General Naturopathic Council (GNC) had four ads in the two issues of What Doctors Don't Tell You (WDDTY) we complained about. They were 'case studies' and told about:

  • a degenerative marking on the area of the iris that relates to the pancreas, found by a naturopathic iridologist;
  • an infection of Borrelia Burgdorferi bacteria, suggestive of Lyme Disease, determined by a naturopath;
  • an iris examination suggesting sub-optimal functioning of the pituitary gland, influence on the spleen emanating from the liver, subluxation of no less than four cervical vertebrae that could be impinging on nerve supply;
  • a case history taken by a 'Naturopathic Nutritionist Therapist' who identified factors that could influence the release of histamine or inhibit its degradation in the body.

Needless to say, most of these could be helped with dietary adjustments, osteopathic adjustments, herbal products or the ubiquitous supplements.

The General Naturopathic Council is a small voluntary regulator made up of a number of trade bodies (and the University of Westminster) that claims its aim is:

…to regulate and support naturopathic practitioners in order to ensure the safety and wellbeing of the public. Prevention is better than cure!

Naturopathy covers a wide range of alternative therapies:

The Naturopathic Practitioner makes use of supportive physical forces and agents such as: light, water, air, thermal effects, magnetism, earth, electricity or vibration; and seeks to harness the patient's own life force more directly with massage, through rest, by exercise, by stimulating reflexes, by making dietary prescriptions, by psychotherapeutic interventions or by employing the patient's own heterostatic capacity. The Naturopathic Practitioner may achieve alterative effects by a number of therapeutic approaches, for example: acupressure, acupuncture, colonic hydrotherapy, homeopathy, hydrotherapy, iridology, kinesiology, massage therapy, nutritional therapy, osseous manipulative therapy, phytotherapy (herbal medicine).

We challenged whether these 'case studies' were genuine and that the iridology and iris examinations were valid diagnostic techniques. The ASA told the advertiser to outline proposed amendments to their ads so they complied with the CAP Code.

Since we don't know what was said between the ASA and the General Naturopathic Council, we will need to wait to see their next ad (if any) in WDDTY to find out how they've had to change to comply.

Powered by results

However, it's interesting to note that members of the GNC have to abide by their Code of Ethics and Practice, as set out in the GNC Handbook. In relation to advertising, it includes the following:

The Principles of Advertising
57. The following principles will be applied by the Professional Conduct Sub-Committee and Committee in relation to advertisements by Naturopaths:
c. Advertising shall not contain claims of superiority, specialism or curability and any other claims made shall be capable of substantiation.
d. Advertising shall not be false, fraudulent, misleading, deceptive, self-laudatory, extravagant or sensational.
f. Advertising shall comply both with legal requirements and with the British Code of Advertising Practice [the ASA's CAP Code].

It would have been hoped that the GNC would have applied those same rules to its own advertising on behalf of its members.

asthma care kentAsthma Care Kent

This was another ad for the Buteyko method of breathing that claims to significantly improve asthma. Some of its proponents claim that asthma is caused by 'over-breathing' and that asthma can be helped by breathing less using their proprietary method.

The claims by Asthma Care Kent included:

  • Stop asthma controlling your life
  • Up to 90% less reliever and 50% less preventer
  • Less coughing and less wheezing
  • Better sleep
  • More energy
  • Better safer control
  • More physical activity
  • Improved quality of life

We challenged all these claims, saying we doubted the advertiser could substantiate them. The ASA told Asthma Care Kent to remove all the efficacy claims for the Buteyko technique.

comra devicecoMra™

All the cases so far have been informally resolved by the ASA. This means that the ASA simply told the advertisers to remove claims they considered were not allowed by the CAP Code.

Our first ASA adjudication against advertisers in What Doctors Don't Tell You is published today.

This was an ad for something called a coMra™ 'delta laser' device that provides coMra™ (coherent multi-radiance) therapy. The company that manufactures and sells this device is Radiant Life Technologies.

There were two different ads: a full-page ad in the September issue and a half-page ad in the October issue.

This is a medically-looking device and, according to their website:

coMra-Therapy is a non-invasive therapy, which combines an infrared laser with a magnetic field, ultrasound and colour LEDs in a fully coherent treatment.

We'll leave it to you to work out what the attachments on the right of the picture are used for…

The ads claimed:

the latest towards holistic, medical self-sufficiency

Free yourself from the allopathic medical system!

We believe that the power to heal belongs in your hands! Not in hands of a corrupt system.

We believe in freedom!

The claims in their ads included:

  • allergies
  • arthritis
  • asthma
  • autoimmune
  • blood
  • bones
  • cystitis
  • dental
  • dermographia
  • diabetes
  • eczema
  • fibromyalgia
  • glands
  • helping with long-standing, chronic conditions
  • immune system
  • injuries
  • ischemia
  • joints
  • kidneys
  • mastitis
  • multiple sclerosis
  • muscles
  • neurology
  • organs
  • osteoporosis
  • polyarthritis
  • reducing pain
  • skin
  • speeding up recovery
  • sports injuries
  • stress
  • strokes

And if that wasn't enough:

  • and many more

But the list of 'treatments' on their website is even more impressive.

We challenged whether they could substantiate those claims and whether the three testimonials they gave in the larger ad were genuine.

Competent Authority

Radiant Life Technologies should already have been well aware of what they are and are not allowed to claim in ads: they had fallen foul of the ASA last year and the adjudication against them is well worth reading.

This time, when the ASA contacted them for evidence to substantiate the claims we challenged, they responded:

Radiant Life Technologies said they could substantiate the testimonials to any competent authority should the need arise. However, they declined to supply a substantive response to the ASA's enquiries.

Needless to say, in the absence of evidence for the claims, the ASA upheld our complaint.

But we couldn't leave it at that. 

The ASA is considered the 'established means' for gaining compliance with the Consumer Protection from Unfair Trading Regulations 2008, which governs how businesses interact with consumers and the Business Protection from Misleading Marketing Regulations 2008, which governs how businesses advertise to each other. This means that the law itself is not usually enforced formally through the courts; instead the ASA is first allowed to tackle any problems under the Advertising Codes. This approach works well in the overwhelming majority of cases. They can take matters further, of course, by referring advertisers who refuse to work with them and persistently make misleading claims to the Office of Fair Trading (OFT) for legal action.

However, in this case, we have an alternative route and we wanted to give Radiant Life Technologies the opportunity to provide their evidence to a suitable 'competent authority', even if they didn't think the ASA worthy of such an accolade.

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe, ie that they comply with the Medical Devices Directive and other legislation. The MHRA is an executive agency of the Department of Health:

The MHRA is the competent authority (CA) for the UK. On behalf of the Secretary of State for Health, we administer and ensure compliance with medical device legislation in England, Northern Ireland, Scotland and Wales. The MHRA meets its CA functions in the following ways:

Enforces the regulations by:
investigating allegations received about possible non-compliance with the regulations

We wondered if the MHRA were competent enough for Radiant Life Technologies, so a complaint about the coMra™ device is now in their hands.

We'll let you know the outcome.

12 December 2012

WDDTY #1 - The First of Many

Back in October, we told you of the complaints about the 26 adverts in the first two issues of the new monthly magazine What Doctors Don't Tell You we submitted to the Advertising Standards Authority (ASA).

The ASA have been working on resolving our complaints and have started dealing with just about all of them.

Many will be informally resolved by the advertiser agreeing to remove the claims the ASA find unacceptable.

Others are being fully investigated by the ASA, asking the advertiser for the evidence to substantiate the claims made — remember that an advertiser must hold that evidence at the time the claim is made, not just come up with it later when challenged. If they cannot supply that evidence or it is not up to the ASA's standards, they are likely to lose the adjudication with full details published on the ASA's website for all to see.


Today, the first two of the informally resolved cases are published.

learnbuteyko.co.uklearnbuteyko.co.uk

The Buteyko Breathing Method purports to be a breathing technique that can help with conditions such as asthma.

The claims this ad in WDDTY made went well beyond this:

For optimal physical and mental health and the reversal of chronic disease

The Classical Buteyko Breathing Method is an effective drug free approach to bringing about optimal health and managing chronic symptoms such as:

  • allergies
  • depression
  • hormonal disorders
  • insomnia
  • anxiety and panic attacks
  • eczema
  • hypertension
  • weight problems
  • asthma
  • hayfever
  • fatigue
  • pain and more

The ad appeared in the September issue of WDDTY. There were smaller, 1/8-page ads in the first three issues, but these made no claims.

We questioned these claims. The ASA agreed with us that we had a valid point and told the advertiser to change their ad, instructing them to remove all efficacy claims for the technique.

Because it was informally resolved, all the ASA publishes is basic details of the case — but the advertiser is still named.

Similar claims are made on the learnbuteyko.co.uk website and we hope the advertiser will take this opportunity to ensure the website also complies with the ASA's CAP Code.

Wholistic Research 1Wholistic Research

There were two different ads in the first issue and one of them repeated in the second, all making the same claims. The ads were by Wholistic Research for their water filter product.

They stated:

Clean up your polluted drinking water and make sure you drink lots of pure water to hydrate and cleanse your cells…

We challenged the claims and said we believed it could make readers worry unnecessarily about their drinking water and put undue pressure on them to buy the product.

The ASA initially decided to investigate and ask the advertiser for evidence. However, the advertiser agreed to change the wording in future ads to resolve our complaint.

The advertiser should now be well aware of the ASA's CAP Code and I hope they will ensure that the ad on their website for their water filters also complies.

Future issues

There are many more informally resolved complaints and adjudications to come and it will no doubt take some time, but we will let you know the progress.

Meantime, we will not be complaining about any of the ads in the latest (November) issue. The ASA need time to do their job and deal with the advertisers — and with the magazine publishers if necessary — to ensure that the ads in any future issue comply with the CAP Code.

However, we are keeping a detailed tally of the ads. In the September issue there were 38, 35 in October and 35 in November. Many of these ads are the same or very similar, but what is interesting is that there are only 39 different advertisers in total over the three issues. Out of 100 pages per issue, that doesn't seem like very many.

14 November 2012

The continuing saga of Holland and Barrett

This really should have been very simple — and sorted out a long time ago.

Holland and Barrett advertises the Nelsons homeopathic products it sells in its stores. The advertising of these products is controlled by regulations and enforced by the medicines regulator, the MHRA. The advertiser should already have known and understand those regulations and what is and isn't permitted when advertising these products.

But it seems they didn't know. After a complaint from us, the MHRA told them to ensure they complied and Holland and Barrett told the MHRA they would take action to rectify the situation. That was at the start of 2012.

Then in July, we found out that they were still not complying with the regulations, so we submitted another complaint to the medicines regulator.

We sent them photographs sent in by our supporters from eight Holland and Barrett stores up and down the country that still had the point-of-sale advertising that the MHRA had told them was not permitted.

Richmond (07 July 2012) 2

Richmond (07 July 2012)

Bury St Edmunds (20 June 2012)

Bury St Edmunds (20 June 2012)

Camb Lion Yard

Cambridge Lion Yard (25 May 2012)

Cambridge Grafton (25 May 2012)

Cambridge Grafton (25 May 2012)

Kensington High Street (25 June 2012)

Kensington High Street (25 June 2012)

Saffron Walden (29 April 2012) -1

Saffron Walden (29 April 2012)

Trafford Centre (30 July 2012) -03

Trafford Centre (30 July 2012)

Stortford (7 June 2012) -3

Stortford (7 June 2012)

Stortford (7 June 2012) -2

Stortford (7 June 2012)

 

Note the different format of the advertising in the Stortford store.

This sorry tale started last December — and it's still not successfully concluded.

As reported on The Twenty-First Floor, and although it took the MHRA some time — and some prompting — their ruling on our last complaint was finally published on their website today:

Advertising homeopathic products in Holland and Barrett stores, July 2012

Advertising investigations

22 October 2012

The Nightingale Collaboration complained to the MHRA about point of sale advertising of Nelson's homeopathic products in six Holland and Barrett stores and advertising on their website. The complainant was concerned that the advertising included indications for use but the products were not licensed with indications. A similar complaint investigated in November 2011 concerning the same point of sale materials and website was upheld and Holland and Barrett had agreed to withdraw the materials from all stores and review their website.

The MHRA upheld this complaint. Holland and Barrett stated that the advertising materials were displayed in a small number of stores due to a miscommunication. They issued another communication to withdraw the advertising from their stores and amended the information on their website.

Date case raised: 12 July 2012
Date action agreed: 9 August 2012
Date of publication: 22 October 2012

When the MHRA informed me of the outcome at the start of last month, they said:

We have once again been in correspondence with Holland and Barrett again and have completed our investigations. You may wish to know that the point of sale materials were mistakenly displayed in Holland and Barrett stores and have now been withdrawn from the stores.

Holland and Barrett have agreed that we can make a copy of their response to your complaint available to you. This is enclosed and provides their comments on this advertising feature and addresses the concerns raised in your email of 12 July 2012.

In Holland and Barrett's response to the MHRA, they stated:

We were made aware around middle of July 2012 that a very few H&B shops had not removed the booklets as we had instructed late last year. It had come apparent that this was due to some stores having another booklet that was not displayed to customers but was sent out by the suppliers 'Nelson' previously to help our store staff with knowledge of the products. Hence certain stores assumed that this was the booklet referred into the recall and not the one that was displayed.

Therefore we re- issued a new memo to the stores clearly advising of the booklet displayed on the shelves next to the products that need to be removed. Please see attached a copy of the memo sent. We have called all the stores listed in the complaint letter and they have all removed the displayed booklet and sent it back to depot since this revised memo was issued.

It was all a mix-up and miscommunication, apparently.

But at least this new memo made everything clear:

URGENT MEMO

NELSONS HOMEOPATHIC BOOKLET

"WHICH REMEDY DO I NEED"

 

To:                  H&B / NW Stores

From:              Technical Services

Date:               24th July 2012

Subject:           Nelsons Homeopathic Booklet "Which Remedy do I Need"

Reason:           MHRA Complaint – Booklet is making medicinal claims that are not allowed

 

A recall was put on pulse back in December 2011 for these booklets to be removed and returned back to depot, however it has been bought to our attention not all were removed and/or returned.

Therefore can you please check if your store still has this booklet on display or is still available in your store.

If so, remove the booklet from display/store immediately and also any other POS notices with the Nelsons range products that have a reference to the booklet.

 

Product

Nelsons Homeopathic Booklet "Which Remedy do I Need"

 

Action Required – Please check to see if you still have the above booklet in your store next to the Nelsons Homeopathic products or in store, if you do then remove immediately, place in an envelope (with your store name and number on the front) and return to the warehouse with your delivery driver for the attention of Technical Services.

You'd have thought that that would be the end of it and that all Holland and Barrett stores would all now be complying with the medicines regulations.

Apparently not. 

Blogger Josephine Jones sent us a photograph she took in the Trafford Cernte in Manchester this morning:

Trafford Centre (22 October 2012)

Needless to say, a third complaint has been submitted to the MHRA.

22 October 2012

What They Don't Tell You

questionmarkMany of you will be aware that a new monthly magazine called What Doctors Don't Tell You is being sold in various retail outlets including WH Smith and many supermarkets.

We were dismayed to see that the magazines carry many adverts for products and services that we believe are making questionable claims, which could mislead the public.

There is, of course, a responsibility on all advertisers to comply with the Advertising Standards Authority's CAP Code and this publication and its advertisers are no exception.

In view of the seriousness of many of the claims being made, we have submitted complaints to the ASA about a number of adverts found in the first and second issues.

In the September 2012 issue, we counted a total of 37 ads, with 34 in the October issue. Some of these are duplicate ads for the same service or product.

We have submitted complaints about 26 adverts.

We believe this may be the greatest number of complaints submitted to the ASA for a single publication.

We'd like to remind our supporters that the ASA only need one complaint to investigate an advert — additional complaints about the same ads only places an unnecessary burden on the ASA and will not change the outcome. We believe we have covered the vast majority of questionable claims, so we would suggest there is no need for anyone else to submit any further complaints.

It is, of course, up to the ASA to investigate and decide whether or not any of the ads we've highlighted are in breach of the CAP Code and to rule accordingly.

We will let you know the outcome of our complaints in due course and we will, of course, be monitoring all future issues for similar questionable claims.

04 October 2012

Still Being in Stillness

Late last year, we reported that the Advertising Standards Authority (ASA) had adjudicated on the Being in Stillness (BIS) website, which was one of the three websites in our 'master' complaint about the promotion of craniosacral therapy (CST).

The ASA identified ten points in our complaint and upheld them all.

Independent Review

ReviewBIS asked that the adjudication be reviewed by the ASA's Independent Reviewer, Sir Hayden Phillips.

There are just two grounds for a review: the person requesting the review must be able to establish that a substantial flaw of process or adjudication is apparent, or show that additional relevant evidence is available.

The details of requests for review are not published, so all we know is that the request was rejected by Sir Hayden, presumably because the request met neither of these grounds.

While a review is in progress, the ASA removes the adjudication from their website. It has now been republished.

Second complaint

Meanwhile, we noted that, in spite of the adjudication, the website remained much as it was. Additionally, some new text had appeared denying that the website contained any claims; rather, that it carried a "a genuine description" of the experience of many practitioners and clients of craniosacral therapy together with the standard protestation that the scientific method can't be applied to complementary therapies and that "the mention of certain conditions is not intended to imply or guarantee a 'cure' for those conditions; nor any others; and nothing in this website is intended to discourage you from seeking medical advice where applicable".

Further text argued that CST works with "our underlying vitality" and supports "our body's innate healing and self-repair" (though no explanation of how it does this was provided). Thus, it was claimed that CST "may be of help with almost any situation", specifying a long list of conditions that included depression, M.E., recurrent infections, digestive problems, menstrual disorders, tonsillitis, asthma, autism and babies' colic.

There was also a claim that CST may be useful in supporting older people in their various ailments and women through pregnancy and childbirth.

So we submitted a second complaint and the adjudication on this is today published on the ASA's website.

As expected, our complaint was upheld on both counts: that the claims implied that CST was effective in treating the conditions named and that people could be discouraged from seeking essential treatment.

Response

In response, BIS had argued that the website doesn't state that CST can treat conditions, in fact, it states that they do not guarantee a cure for any ailment. They held the view that visitors to the website will not see the anecdotal claims as objective and capable of substantiation.

The ASA, however, considered that the text implied that a cure was at least possible through CST, even if not guaranteed. They also considered that claiming to work with "the whole person rather than conditions" and with "many different situations and conditions" followed by a list of medical conditions did indeed imply that CST could treat those conditions and that this could discourage readers from seeking essential treatment for them.

The full adjudication is quite lengthy but worth reading as an illustration of how some practitioners think they can avoid compliance with the advertising regulations and how the ASA sees right through them.

Responsibilities

Like it or not, all advertisers have a responsibility to abide by the CAP Code and ASA adjudications. It is the level playing field that ensures that the public are not misled by advertising and the ASA provide an independent means for claims to be challenged and for advertisers to present their evidence for their claims. Responsible advertisers know that and are happy to abide by the Code and adjudications, even if the result is not what they might have liked.

We note that the list of conditions and the other claims the ASA has deemed misleading have now been removed from the craniosacral page on the BIS website (for comparison, the page we complained about is cached here) and we welcome this. However, the page now contains a longer section on the ASA and its decision and tries to argue that CST does not lend itself to scientific investigation.

In light of this adjudication, we now hope that other craniosacral therapists will review their own websites to make sure they are on the right side of the ASA's CAP Code and their guidance on craniosacral therapy. We also hope that the CST trade bodies take responsible action to help and encourage their members to do the same.

If they are still in any doubt about what they can and cannot say, there is always the ASA's free Copy Advice service.

01 August 2012

Accrediting nonsense

accredited homeopath

Our response to the CHRE's Accredited Register scheme

Last time, we asked for your help in making sure the Council for Healthcare Regulatory Excellence (CHRE) didn't allow alternative therapy organisations on to its new Accredited Registers scheme. We believe this could pave the way for alternative therapists to claim they are 'officially accredited' or 'Goverment accredited', particularly if they display the schemes 'quality mark'.

We believe this would simply mislead the public into thinking these therapies are legitimate and have a Government seal of approval.

Many of you wrote to the CHRE and sent us a copy of your submissions. Our thanks to everyone who did and we hope the CHRE will take note.

accredited crystal healerWe also submitted our response. We wrote it with several aims in mind. Firstly, since the CHRE oversee a number of statutory regulators of health care professionals (as well as chiropractors and osteopaths), we wanted to make sure that they knew what they would be getting into and what the implications might be for their credibility and that of legitimate health care professionals.

We highlighted the reason many occupations are considered alternative is that they do not have robust evidence to substantiate what they do and the claims frequently made about them by their practitioners and trade bodies. Another common feature is that they frequently have no plausible mechanism of action — as exemplified by homeopathy and crystal healing.

Additionally, we illustrated that, even though many alternative therapies are, in themselves, fairly harmless, there are indirect harms and risks that need to be considered. These include a frequent disdain or even outright antipathy for the many health professionals — particularly medical doctors — whose statutory regulator falls within the CHRE's remit and we drew attention to the distrust of vaccines by many alternative therapists.

We also highlighted many of the clauses in the standards proposed and how they needed to be strengthened so the public are better protected.

You can read our full submission here, but we concluded:

1. We strongly recommend that the CHRE do not allow onto their Accredited Register any organisation whose registrants provide alternative therapies that do not meet the basic requirements of having a robust evidence base or that does not have an assessment of safety that ensures that the public will be properly protected.

We believe that to do so would be detrimental to:

  • the CHRE’s reputation;
  • public confidence in the CHRE and its regulated professions;
  • public health and safety;
  • the reputation of other Accredited organisations.

2. We strongly recommend that the standards ensure that the public are given independent and unbiased information about the evidence base for treatments.

3. We strongly recommend that the standards ensure that the public are given independent and unbiased information about the risks associated with treatments.

This scheme is supposed to be up and running in November and we'll let you know when the CHRE publish their final eligibility criteria and standards.

Holland & Barrett update

As a result of further information we received from our supporters about point-of-sale advertising for homeopathic products in Holland & Barrett stores, we decided that writing to their head office wasn't sufficient to get this issue resolved once and for all.

It appears that some store managers have been told by their head office that there was nothing wrong with the advertising, despite the MHRA's previous ruling on our complaint.

So, we have submitted another comprehensive complaint to the MHRA, including many of the photographs of the POS advertising you sent to us.

It will no doubt take the MHRA some time to deal with this, but we are confident of the outcome. We'll let you know in a future newsletter.

Kensington High Street London 25-6-12

Holland & Barrett, Kensington High Street, London

23 July 2012

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