Challenging misleading healthcare claims

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The final reflexology ASA master complaint

feet2The Advertising Standards Authority (ASA) has published its adjudication on the third and final of our reflexology master complaints.

The website of Tamsin Marshall Reflexology was chosen as one of three reflexology websites for our master complaint because of the broad range of questionable claims being made. Two of the pages carried long lists of conditions under the claim that reflexology "can be used in the treatment and relief from" them.

Given that reflexology apparently involves nothing more than pressing different areas of the feet and hands, we challenged whether this therapy could actually help the conditions named and whether the claims on the website could have the consequence of discouraging people from seeking essential medical treatment.

The ASA additionally challenged whether the efficacy claims in the customer testimonials could be substantiated.

The evidence submitted by the website owner in support of the claims on her website did not meet the standard required by the ASA and the complaint was upheld on all four points, identifying a total of 24 breaches of the CAP Code.

Making changes

We note that some amendments to the main text of the Tamsin Marshall Reflexology website have been made recently and that cancer has been removed from the list of conditions on the About Reflexology (cached) page. However, the website still carries the claim that reflexology can be used in the treatment of many serious conditions including asthma, "eye and ear disorders", endometriosis and polycystic ovary syndrome. It also still carries the customer testimonials that the ASA had objected to.

As it is now eight months since the ASA's remit was extended to include websites, some six months since this practitioner was notified of the complaints and a fortnight since she was notified of the adjudication, it is surprising that she has made little progress in making her website comply with the standards of truthfulness required by the ASA, so that we as consumers are better able to make an informed choice.

We are encouraged, however, to note that the first of the reflexology websites we challenged, Jackie Ginger Reflexology, which was adjudicated on two months ago, has now been amended accordingly, which shows it can be done. The other website we complained about, The Reflex Clinic, is still down at the time of writing.

The ASA continue to work with those responsible for the long list of other reflexology websites we supplied and with the relevant reflexologist trade bodies. This process will take time, but we are confident that the ASA will succeed in ensuring that these websites become legal, decent, honest and truthful — as they should be.

Credit

handsWe seem to be getting the credit for quite a lot of the complaints being made to the ASA about misleading websites, even if the complaints weren't submitted by us!

For example, we came across a blog called Reiki Medicine [sic] with the story of complaints made to the ASA about the website of a reiki practitioner in Newcastle. We are told that the complaints are believed by the practioner in question to have "originated with the Nightingale Collaboration" and that she "expressed concern about skeptic groups in effect dictating the work of the ASA because of personal beliefs rather than in the best interest of the general public".

We don't know whether the complaints about this particular website were inspired by the Nightingale Collaboration or if the complainant was assisted by the information on our website. What is clear is that there were a number of very questionable claims on this particular website, beginning with, "Reiki is believed to have many beneficial effects by: Treating the symptoms and causes of illness…" and that one or more members of the public objected enough to take the time to complain about them.

The result is that these claims have now been removed from that website, whose owner advises other practitioners receiving complaints:

…to not take it personally, and to view it as a challenge rather than as an attack… This is an opportunity to be clear about our own information and intention, and to demonstrate a professional and reasoned attitude to both complainants and the ASA… It is possible to play the game and remove taboo words, not list conditions, and be more creative with language.

Good advice, on the whole, though we are a bit dismayed to see promoting a healthcare therapy in a way that is honest and decent and unlikely to mislead people who may be ill and vulnerable being described as "a game".

No indications allowed: how you can help!

Boots Pharmacies had their knuckles rapped recently for listing medical conditions in their in-store, point-of-sale (POS) advertising of homeopathic products by the medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

POSDisplayThe products — made for Boots by A Nelson & Co Ltd — are not licensed with therapeutic indications, ie they are not allowed to say what medical conditions the manufacturers think they can be used to treat.

This isn't because — as many homeopathists would have us believe — there is some big conspiracy against homeopathy, but because, for the homeopathic products registered with the MHRA, not one jot of scientific evidence of their efficacy is required as part of that registration. Advertising the products with therapeutic indications would therefore be misleading.

This advertising, found in many Boots stores, took the form of a booklet of next to a rack of homeopathic products. The booklet listed indications, symptoms and corresponding homeopathic products. Boots have now agreed to remove all such advertising from their stores.

But Boots aren't the only shops that sell homeopathic products and many others have similar POS advertising that lists medical conditions for those products: we've seen it in branches of high street 'health' food shops, particularly for Nelsons own-branded products.

How can you help?

We are sure that Boots will take their responsibilities seriously and remove all such advertising. But what if you find a store that hasn't? What do you do if you find a health food shop with a similar booklet?

You could politely ask to speak to the manager or the Superintendent Pharmacist and make them aware of the MHRA's decision against Boots and ask them if they will review their advertising.

But if you're not confident about doing that, we have produced an information sheet that you can download and print out (in black and white or colour) to help you.

We've made the sheet informative and non-confrontational: it simply gives details of the MHRA's decision and asks that the shop reviews its in-store advertising to make sure it complies with the MHRA requirements.

If you are successful in persuading a shop to remove these unlicensed indications, please let us know; if you find that the advertising hasn't been removed, please also let us know.

 

POS_advertising_of_homeopathic_products

Working within the "cranial paradigm"

The Advertising Standards Authority (ASA) published another of our 'master' complaints today. This time it was about claims being made on a website advertising craniosacral therapy, Being in Stillness (BIS). The full adjudication can be found here, but it's worth considering some of its points.

As part of their general response, BIS stated that they:

…worked within the cranial paradigm, rather than a conventional scientific paradigm.

The didn't, however, explain in any understandable terms what this different paradigm was other than to claim:

[craniosacral therapists] worked with the subtle energies of the individual, which represented and seemed to correspond to physical tissues and emotions. Practitioners, experienced in their hands certain sensations, or ‘energy fields’, around the client, which was in turn experienced by the client as subtle movements in the body, or various emotions and insights. BIS said that was a highly subjective experience and each practitioner may experience the work differently.

None of this is evidence-based, of course. The BIS website explains further:

'Being in Stillness' means resting in a place of deep peace and wholeness that encourages profound relaxation of the body, mind, emotions and energy, and enhances our natural healing, self-repair and self-correction abilities, reminding us who we are underneath the conditioning of our day to day lives and unresolved experiences. It is inherently non-judgmental, honouring our body's present perception of how things feel.

Recognise this for what it is: non-specific yet possibly sciency-sounding to some and typical of far too many webpages promoting alternative therapies.

However, it's a huge leap from talk of relaxation to claims that this can treat any illness or condition, never mind serious ones like the ones mentioned by BIS: autism, learning difficulties, epilepsy, recurrent infections, migraines, headaches and asthma that need proper medical attention, as well as all the usual suspects of colic, feeding problems, poor sleep and 'failure to thrive'.

But another recurrent theme on many sites advertising alternative therapies is 'birth trauma'. This is certainly a favourite of many chiropractors and suchlike, but preys on women at a time when they are understandably concerned about the well-being of their baby. BIS stepped up the pressure:

During birth the baby's head is subjected to strong compressive forces. Particularly with a long or difficult labour, forceps or ventouse [suction] intervention, there may be residual effects which need some help to clear. Craniosacral therapy recognises the subtle effects of birth trauma on the still-forming bones of the skull which if left untreated may lead to more persistent problems.

Fully upheld

The ASA identified 10 points in our complaint and upheld them all, including one that the ad could discourage people from seeking essential treatment for conditions for which medical supervision should be sought.

However, it is disappointing to note that, although the page on craniosacral therapy (cached) on the BIS website has changed in light of the ASA's adjudication and some text has been altered, the website now contains three disclaimers in what would appear to be an attempt to comply with the adjudication, but without removing many of the claims or the long list of medical conditions. The ASA have been notified of this.

Regulatory paradigm

In the regulatory paradigm, claims made have to be evidence-based and the ASA require that evidence be robust and scientific. The ASA demand this because their remit is to protect the public from being misled: if an advertiser makes a claim, the advertiser should be prepared to substantiate that claim with robust evidence. If they cannot substantiate it, then they should remove the claim.

Now that this adjudication adds to the CAP Code and previous adjudications on craniosacral therapy, there can even less excuse for craniosacral therapists to make misleading claims.

BIS should have been well aware of these requirements: the therapist at BIS is Amanda Biggs and she is a member of the Craniosacral Therapy Association of the UK. The reason the CSTA know all about the ASA's rules is because of the adjudication against them just over a year ago after a complaint by Al Grant. The ASA have also told us that they had informed the CSTA of our current complaint.

As part of our complaint, we supplied the ASA with a list of several hundred other cranisacral therapy websites and the ASA will now be contacting them to ensure they are well aware of the rules they have to abide by. They will now also be contacting the CSTA again and another trade body, the Upledger Institute, to inform them of their decision and to work with them to help seek compliance by their members.

We sincerely hope that both trade bodies will realise their professional responsibilities and cooperate fully with the ASA to bring their members into line with the CAP Code.

Boots told to stop making medical claims for pills with no active ingredient

Boots Pharmacies have been told to stop listing medical conditions in their in-store advertising of homeopathic products by the medicines regulator, following a complaint by Simon Perry.

The point-of-sale advertising in Boots stores recommended homeopathic products as suitable treatments for a wide range of medical conditions including allergies, infections, insect bites, headaches and earaches. But homeopathic products contain only sugar — they have no active ingredients.

The products Boots were advertising (manufactured by A Nelson & Co Ltd of Wimbledon) are prohibited from indicating any medical conditions by the Medicines and Healthcare products Regulatory Agency (MHRA), which is the statutory body charged with regulating medicines and homeopathic products.

The Boots products are registered under the MHRA's Simplified Scheme for homeopathic products. This does not require the manufacturer to provide any evidence that they actually work — unlike the conventional medicines licensed by the MHRA.

Alan Henness, Director of the Nightingale Collaboration, which campaigns against misleading healthcare advertising to the general public, said:

This is a victory for informed consumer healthcare choice. These products are frequently displayed near the pharmacy areas and could mislead members of the public into thinking they were effective medicinal products. However, as well as being biologically improbable, there is no good scientific or medical evidence that any homeopathic product has any effect over placebo.

Boots came under pressure in 2009 after telling a House of Commons Select Committee they sold homeopathic products despite having no evidence or belief that they were effective for any condition. This admission prompted consumer demonstrations against the high street store, with the 10:23 Campaign protesting sales of the products by publicly overdosing on Boots-brand homeopathy.

Mike Marshall, co-founder of the 10:23 Campaign said:

When we set up the 10:23 Campaign, we appealed to, and petitioned, Boots to remove homeopathic products from their stores — as a responsible and respected healthcare provider we strongly believe they should value their customers enough not to sell them ineffective so-called 'medicines'. With many people considering Boots synonymous with good-quality health advice, their sale and advertisement of useless treatments to trusting customers ought to be utterly unacceptable.

As such, we wholeheartedly welcome this ruling from the MHRA — hopefully it should result in fewer people being fooled into believing that homeopathy is effective, and ensure there's less time and money wasted on products which have been comprehensively demonstrated to be ineffective.

Alan Henness went on to say:

Manufacturers of homeopathic products are being put under increasing pressure by regulators to abide by the same rules that other advertisers have to abide by. While anyone is free to make their own healthcare decisions, they must be given full and impartial information about those choices. Misleading information can be dangerous and must be challenged.

Notes

  1. The MHRA stated:
  2. The Advertising Standards Unit has recently taken action in response to a complaint from a member of the public about specific advertisements in Boots stores.  The complainant was concerned that the advertisements included indications for use but the products were not licensed with indications.  The MHRA upheld the complaint.  Boots withdrew the advertisements from their stores.
  3. The Nightingale Collaboration was set up to challenge misleading claims in healthcare advertising and to encourage anyone who is concerned at protecting the public from misinformation in healthcare promotion to join them in challenging it.
  4. The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency that is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health.
  5. Boots have over 2,000 pharmacies in the UK.
  6. The MHRA state:
  7. The Simplified Scheme

    In 1992 Directive 92/73/EC introduced a Simplified Scheme for homeopathic products. It is regarded as simplified because although the safety and quality of products has to be demonstrated, products are not permitted to make medical claims. The Scheme is restricted to products for oral and external use and does not allow indications (the descriptions of diseases or conditions for which the medicine is intended to be used). In order to qualify for registration the products must:

    • be for oral or external use - this includes all methods of administration with the exception of injections

    • be sufficiently dilute to guarantee their safety

    • make no therapeutic claims.

    Another reflexology complaint upheld

    The Advertising Standards Authority (ASA) today published its adjudication on the second of our reflexology master complaints, following on from the first against Jackie Ginger Reflexology four weeks ago.

    Our complaint was upheld on the three issues we raised as well as one the ASA themselves added.

    The Nightingale Collaboration challenged whether the:

    1. efficacy claims for reflexology were misleading and could be substantiated;

    2. disclaimer contradicted, rather than clarified the main text on the website;

    3. website discouraged essential medical treatment for conditions where medical supervision should have been sought.

    The ASA challenged whether the:

    4. efficacy claims in the testimonials could be substantiated.

    feetThe ad on the website of The Reflex Clinic (www.reflexclinic.com)1 made numerous claims about reflexology and we doubted the advertiser held the necessary robust scientific evidence required by the ASA.

    Their website has been completely taken down, but pages are still in Google's cache. However, we had taken snapshots of the pages we submitted to the ASA and their home page can be seen here. You can also see a comprehensive list of medical conditions mentioned in the ad in the ASA's adjudication. This included:

    Fertility Issues, Pregnancy Issues, Prostate Problems; Glandular System - Metabolic - Hormone Imbalances, Thyroid Imbalance, and Adrenal Stress; Circulatory System - Hypertension, Stress, Poor Circulation and Oedema; Respiratory System - Asthma, Hay Fever and Sinusitis; Immune System - Viruses (M.E., glandular fever, Epstein Barr), Cancer…

    Disclaimer

    The Reflex Clinic were obviously aware of the ASA and even mentioned them in their ad in a disclaimer. However, the ASA were not impressed by it, deciding that the disclaimer contradicted the claims made in the main text and that, particularly in relation to the claims made for cancer, depression and auto-immune disorders, they therefore:

    …did not consider the disclaimers were sufficient to ensure individuals were not discouraged from seeking medical advice.

    Overall, the ASA found the website breached the CAP Code on 18 counts.

    Reflexology portal

    What is very interesting is that The Reflex Clinic said:

    …they were a reflexology portal, offering reflexologists a fully managed website service, and providing information about reflexology to the public. They said they had 2,000 web pages nationally.

    Since the website has now been completely taken down, that's potentially a very large number of claims that are no longer misleading the public.

    However, we will be monitoring the website and will be looking at it closely if and when it reappears.

    Compliance

    This adjudication adds to the ASA's existing guidance and previous adjudications for the advertisers of reflexology and there should be no excuse for anyone to making misleading, or dangerous, claims.

    Of course, if they are in any doubt about what they can say in their ads, the ASA's free Copy Advice service is available.

    Negative ions, far infrared rays and alpha waves…

    Black TourmalineAn adjudication against Ionic Balance was also published today. Although this was not as a result of a complaint made by ourselves, it makes an interesting read.

    Ionic Balance sell Power Balance-like silicone bracelets that they claim has all sorts of benefits including enhancing immune function, boosting metabolism, stabilising blood pressure and regulated serotonin levels. How does their product achieve this? Well, it doesn't have a hologram in it like the Power Balance; it has a tourmaline gemstone in it, which emits "negative ions, far infrared rays [ie heat] and alpha waves", apparently.

    The advertiser provided the ASA with 28 documents that they believed substantiated the claims that "negative ions, far infrared rays and alpha waves" had beneficial effects on health. The documents fell short of the ASA's requirements for all sorts of reasons and the ASA obviously spent some considerable time wading through them. However, if tourmaline did indeed emit negative ions and heat, it may be a contender to resolve the world's energy problems as well as improving health. We won't speculate on the effects of a gemstone emitting alpha waves.

    But there is no mention in the ASA's adjudication that the advertiser had provided any evidence that their product did, in fact, emit negative ions or heat or alpha waves, so it's not clear to us why the ASA even bothered with evaluating the 28 documents!

    Regardless, the ASA found the ad breached the CAP Code on no less than 22 counts.

    26 October 2011

    __________

    1 Not to confused with The Reflexology Clinic (www.reflexclinic.co.uk).

    Reflexology complaints

    reflexologyThe first Advertising Standards Authority (ASA) adjudication on a complaint submitted formally by the Nightingale Collaboration is published today.

    Complaints against three reflexology websites were submitted in June as 'master complaints'. From the many websites we perused, these three were selected as containing very clear and typical examples of the kind of questionable claims widely made on UK reflexology websites.

    It was notable that — no doubt emboldened by recent articles in the Dail Mail1,2 — a great many practitioners claim that reflexology (or 'reproreflexology') can in assist conception in couples undergoing fertility treatment. (Searching for 'reflexology infertility site:.uk' on Google gave us over 36,000 hits.)

    And, much like homeopaths and other alternative and complementary therapists, reflexologists also frequently include lists of named conditions — many of them serious — on their websites and either imply or state in no uncertain terms that they can treat these conditions.

    In the adjudication against Jackie Ginger Reflexology, the ASA Council upheld our complaints about the claims made by the practitioner to be able to treat the conditions named on her website, firstly, were unsupportable and, secondly, might discourage people from seeking necessary medical treatment.

    Testimonials

    Customer testimonials of the kind expressly disallowed by the ASA Code of Advertising Practice (the CAP Code) also featured on many of the sites we looked at. The CAP Code does not allow marketers to use customer testimonials as a way of making claims that they would not otherwise be permitted to make and, in this case, the ASA treated the claims made in the patient testimonials on Jackie Ginger Reflexology as a separate item and challenged these claims on their own behalf.

    Unsurprisingly, this challenge was also upheld by the Council.

    The full adjudication can be viewed here and we expect the other adjudications to be published shortly as well as our master complaints for other therapies.

    Compliance

    We hope that other reflexologists will take serious note of this decision because it sets a precedent and adds to the ASA's existing guidance on reflexology.

    We also supplied the ASA with a list of reflexologist trade bodies (including the International Federation of Reflexologists, the Association of Reflexologists, the British Reflexology Association and the Complementary and Natural Healthcare Council) and a list of their members' websites. We sincerely hope that these trade bodies will now inform their members of this decision and the requirement to abide by the ASA's guidance and adjudications. We also expect them to take whatever steps are necessary to ensure that their members abide by that guidance.

    The ASA publish clear guidance on many different therapies as well as general advice on what is, and what is not, acceptable. If any advertiser is in any doubt, the ASA's Copy Advice service can give specific and individual advice, which is free of charge.

    New ASA guidance

    Last week, in response to "the marked increase in the number of complaints received by the Advertising Standards Authority (ASA) relating to websites advertising alternative health and particularly homeopathy services and products", the ASA Copy Advice team published some concise and helpful guidance materials for website owners.

    Hopefully these will be read and followed by all practitioners who are marketing their services directly to the public. It would certainly make our job easier but in the meantime, they also serve as a useful resource for consumers who might be considering challenging the questionable claims that continue to appear on thousands of UK websites.

    The guidance can be accessed from here.

    Ask for Evidence

    Finally, we are pleased to help publicise a new campaign by the Sense About Science charity. Launched a couple of weeks ago, Ask for Evidence encourages people to demand evidence for scientific and medical claims. Advertisers, companies, Government bodies and other organisations get away with making misleading claims that, despite the good efforts of regulators, crop up again and again. To address this, Sense About Science are striving to equip people to ask questions about evidence for themselves.

    Visit the website for examples of evidence hunting about claims and for tips about how to respond to claims. The charity has over 5,000 scientists and hundreds of organisations on hand to help.

    To find out more about the campaign, click on the button:

    btn_ask-evidence_webbutton_2011_Aug_31

    ____________________

    1 "Is reflexology the new cure for infertility? | Mail Online", http://www.dailymail.co.uk/health/article-20980/Is-reflexology-new-cure-infertility.html

    2 "Reflexology: can it aid fertility? | Mail Online", http://www.dailymail.co.uk/health/article-172952/Reflexology-aid-fertility.html

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