Challenging misleading healthcare claims

News

News items will be published here, but also sign up to our Newsletters — see the form on the right.

You can receive updates from the News feed, either to your RSS reader or via email.

Campaign News: May 2011

Homeopathy

In March, we tackled homeopathy websites. We had a tremendous response from our supporters and the Advertising Standards Authority are still dealing with the websites we all complained about. They are also working with the various homeopathy trade bodies to ensure they fully understand their obligations and responsibilities under the ASA's CAP Code and this is communicated to their members.

Once their members become aware of what they can — and cannot — say on their websites and other advertising materials, we expect to see a huge reduction in misleading claims being made.

The ASA gave the homeopaths a further three months to comply and change their websites:

We are giving you three months to review and amend the claims you make on your website. At three months, we will monitor compliance. We think this provides all advertisers with sufficient time to make the necessary changes. We will visit your website, along with all the other advertisers' complained about after 1 July 2011. If your website does not comply with the Code in the ways outlined in this letter we may have to take action.

Just in case the message doesn't get out properly, or some are reluctant or tardy in changing their websites, we will be focusing on them again. This won't be another ASA complaints campaign — we want to allow the ASA to take whatever action they see fit to obtain industry-wide compliance — but it will be something that we will need will need a lot of help with and we will let you know later how you can become involved.

More details nearer the time.

Craniosacral Therapy

Again, we've had a fantastic response from our supporters and we believe we have some excellent example CST websites to send to the ASA. We will use the ones with the worst misleading claims as 'test' cases and submit the remainder to illustrate to the ASA the extent of the problem. We will also give the ASA full details of the various trade bodies that have CST members. We anticipate this will help the ASA in ensuring industry-wide complaince, as they are doing with the homeopathy trade bodies. It is hoped that these trade bodies will take responsible and decisive action to ensure their members comply with the CAP Code.

We will keep you informed of our progress.

Other projects

We are working on several other projects including having discussions with the Medicines and Healthcare products Regulatory Agency (MHRA) on several topics of interest including homeopathy, herbals and another one we'd like to keep to ourselves for the time being!

Herbal products

This is a good time to say a bit about the regulation of herbal products.

Herbal products are significantly different from most other forms of alternative therapies in that they frequently contain pharmacologically active chemicals that can cause physiological effects in humans and other animals. They can therefore be dangerous: either intrinsically or because they have been contaminated or adulterated during or after the manufacturing process. It is therefore essential to safeguard the public that these products are regulated.

It's a long and complicated story, but a hot topic of discussion amongst herbalists — whether western, traditional Chinese or ayurvedic — is the ending of a very long transition period on 30 May. This transition period has to do with the implementation of the EU Traditional Herbal Medicinal Products Directive (2004/24/EC). We wouldn't recommend you try to understand it unless you have a penchant for such legalese, but a good, simple summary of what it means to the advertising and selling of herbal products has been produced by the EU: Q&A: Registration of Traditional Herbal Medicinal Products.

Essentially, after 30 May, it will be illegal to sell over-the-counter manufactured herbal products that are not registered by the MHRA under their Traditional Herbal Medicines Registration Scheme (THMRS). There are just over 100 licences that been issued by the MHRA and these will be the only herbal products making medicinal claims that will be allowed to be sold. Other herbal products will be allowed to be sold, but only if they are sold as food supplements, do not make medicinal claims and do not have a physiological or immunological effect.

The MHRA publish Public Assessment Reports for each of the THMRS licences they issue. It's worth looking through one of these to get an idea of what data are required to comply with the THMRS. Taking this one for a Black cohosh product as an example, the main body of the assessment comprises a scant nine pages. It includes:

No clinical efficacy data are required for registration of Traditional Herbal Medicinal Products (THMP).

No studies have been carried out to determine if drug interaction occur with this product.

The safety of the product during pregnancy and lactation has not been established, therefore it should not be used during pregnancy or lactation or by women attempting to become pregnant.

No studies on the effect of this product on the ability to drive or use machinery have been performed.

Pharmacodynamic properties: Not required.

Pharmacokinetic properties: Not required.

Preclinical safety data: The preclinical toxicology data are limited. Tests on reproductive toxicity, genotoxicity and carcenogenicity have not been performed.

However, herbalists are up in arms about this restriction, seeing it as an unwarranted intrusion into their right to freely choose to purchase whatever herbal products they wish. Essentially all the THMRS does is ensure some safety aspects of the products through Good Manufacturing Practice. No evidence of efficacy is required and the scheme is a pale imitation to the requirements that pharmaceutical companies have to comply with to obtain MHRA Marketing Authorisation. But it seems that even this two-tiered system is too much for some herbalists and many are so incensed that they have collected £90,000 to mount an eleventh-hour legal challenge against the EU Directive.

So, if we find unlicensed herbal products that are making medicinal claims for sale in May, can we complain and who to?

Unfortunately, it's not quite that simple. Although the transitional period ends on 30 May, unlicensed products that are already in the supply chain can continue to be sold until they are used up. What is not allowed is for a manufacturer or EU importer to place on the market any unlicensed product after 30 May. The full details of this can be found in the MHRA's guidance.

What this means is that we cannot be certain that any unlicensed product on a shop shelf or being sold on the Internet is illegal. Not knowing the details of a typical supply chain, it's impossible to estimate when unlicensed product placed on the market before 1 June will be used up.

However, we will be monitoring the situation and we will let you know when we think it would be a good time to do some checking. We will also keep you informed of the Government consultation to regulate herbal practitioners.

Focus of the Month

Because of all this activity and planning that's going on behind the scenes, we've decided that we won't have a Focus of the Month for May.

But don't worry, there will be plenty of opportunities to help challenge misleading claims in the near future!

ASA adjudications

The following recent ASA health related adjudications may be of interest:

Comfort Click Ltd

LighterLife UK Ltd

Nuga Best UK & Ireland

Equine America (UK) Ltd

The International Centre for Nutritional Excellence Ltd

Vitabiotics Ltd

Coca-Cola Great Britain

Dr Batra's Positive Health Clinic (UK) Ltd (see here for further details)

The Maperton Trust

Tony Ferguson UK Ltd

Focus of the Month — April 2011: craniosacral therapy (CST)

01 April 2011

Our first Focus of the Month has been a remarkable success and thanks to everyone who has supported our focus on homeopathy by submitting complaints to the ASA and particularly to those who've let us know about the complaints they submitted. (We regret that because of a server problem for a day or so last week, not all of these received acknowledgement but rest assured they were all received and recorded by us.)

We believe that we've done enough for the time being to ensure that homeopaths nationwide are being alerted to the requirement to comply with the ASA's Code of Advertising Practice. The ASA have told complainants that a further three month grace period is being allowed to practitioners to remove misleading claims from their websites (see previous news for further details).

It is encouraging that the ASA are telling advertisers of homeopathy that:

We have seen the most recent, authoritative and comprehensive review of the scientific evidence by the House of Commons Science and Technology Committee entitled “Evidence Check 2: Homeopathy”. This provided an analysis of evidence and opinion submitted by a range of proponents and opponents of homeopathy, including some of the organisations representing homeopathy in the UK and practising homeopaths. The conclusion made clear that there was a lack of objective scientific evidence to substantiate the efficacy of homeopathy. Because the documents submitted for the “Evidence Check 2: Homeopathy” report provided a comprehensive collection of data for assessment, and homeopaths and the various bodies that represent them were invited to submit evidence as part of a consultation process, we do not intend to duplicate that process or assess the evidence again. We know that some studies suggest a positive effect from homeopathy; however, we understand that the evidence, when taken as a whole, does not support the conclusion that homeopathy in and of itself is proven to help or treat health conditions.

The ASA told all the complainants that they believed the best way to achieve industry-wide compliance — something the ASA has considerable experience in doing — was to work with the various trade bodies. They said:

We will however publish specific, up-to-date advice to the industry and its representative bodies in due course and we will work with them to ensure that advertising for homeopathy is compliant with the Code.

We believe this is the right approach. While there are many practitioners who will not be members of a trade body, the message will be heard by a large number of them and will undoubtedly spread to others.

We think the most efficient way forward is not to send any more complaints about homeopathy to the ASA at present but to give them time to complete their ongoing investigations and compliance monitoring.

April 2011: craniosacral therapy (CST)

So, for our new focus of the month — craniosacral therapy — we'd like to try a different approach.

Instead of submitting complaints directly to the ASA, we'd like you to gather the information about CST websites and send it to us so we can submit 'test' cases to the ASA.

arroworangeTo find out how you can help, click here.

arroworangeTo find out more about craniosacral therapy, click here.

ASA respond to complaints about homeopathy websites

The Nightingale Collaboration's first Focus of the month concerned misleading claims made on homeopathy websites. Many of you told us about the websites you complained about and the misleading claims you had found.

The ASA has already responded to those first complaints, revealing that they received over 150 complaints about misleading claims on homeopathy websites. In an email sent to those who complained, they said:

ADVERTISING CLAIMS ON HOMEOPATHY WEBSITES

Thank you for your recent complaint.

As you may know, the Advertising Standards Authority (ASA) has received over a hundred and fifty complaints about over a hundred different websites for homeopathy. Complaints cover a range of issues from specific claims made by individual advertisers to general concerns about the sector as a whole. Because of the volume of complaints, we are sending this letter to everyone who contacted us on these issues to let you know what action we intend to take.

The ASA has an established position on claims that can be made, and those claims that are not likely to be acceptable for homeopathy, based on the requirements set out in the CAP Code and previous ASA adjudications. Although we have not historically received many complaints about advertising for homeopathy, the Code has general requirements for substantiation of claims in the health sector and the Committee of Advertising Practice (CAP) offers specific advice on marketing health-related products and services. Further information about the requirements of the advertising Code is available on our website www.asa.org.uk and from www.copyadvice.org.uk.

We are seeking to enforce compliance with the Code even-handedly across the sector by contacting all of the advertisers we have received complaints about as well as the bodies that represent homeopaths and homeopathy in the UK. We will be explaining the Code's requirements, giving advice on how to ensure advertising claims do not breach the Code, and asking advertisers to remove any claims which do not comply. More information about what that means in practice is provided in the CAP Help Notes on Substantiation for Health, Beauty and Slimming claims and Health, Beauty and Slimming Marketing Communications that Refer to Medical Conditions. You can find these documents on our Copy Advice website, as indicated above. Because the ASA has only been regulating websites since 1 March many of the advertisers we contact will not be familiar with us or the work we do and will need help and assistance from us. For that reason, we plan to monitor compliance 3 months after making our expectations of them clear. We feel that this will give advertisers, some of whom are very small and have limited resources, sufficient time to make the necessary changes.

The ASA will not be publishing individual adjudications on this occasion. We will however publish specific, up-to-date advice to the industry and its representative bodies in due course and we will work with them to ensure that advertising for homeopathy is compliant with the Code.

Thank you for taking the trouble to contact us. While you will not see immediate results please be assured that we are working hard in the background to resolve the issues that have been complained about.

We commend the ASA for responding so quickly to the large number of complaints. We know that many misleading claims have already been taken down from homeopathy websites and we expect that any remaining misleading claims will be removed once the ASA has written to the individual advertisers.

This is a fantastc result and this is what the Nightingale Collaboration is all about — ensuring that members of the public are not presented with healthcare claims that cannot be substantiated.

It is not essential that formal adjudications are published for these complaints: all that matters is that misleading claims are removed.

Grace period

Although the ASA rules only came into force on 1st March, they were fully announced over six months ago with pre-announcements about the ASA's digital remit extension long before that. This six-month period was specifically given and announced as a 'period of grace' so that advertisers had time to understand the ASA's rules, to seek advice from the ASA's free Copy Advice service or attend one of the ASA's training or advice seminars on offer and to change websites accordingly.

However, because of the extent of the problem, the ASA have decided to give homeopathy advertisers an additional three months in which to comply. It is unfortunate that the public may have to wait even longer before misleading claims are removed, but we appreciate that this is a pragmatic decision by the ASA.

Awareness

Whilst it is possible that some homeopaths might have missed the ASA's own advertising campaign — which included extensive commercial radio ads — it seems unlikely that the various homeopathy trade bodies were unaware of the impending requirement for websites to comply with the ASA's CAP Code. It would have been reasonable to assume that they had already taken action to inform their members. However, some of the recent ASA complaints were about misleading claims made by some of the leading members of these trade bodies on their own websites!

This is particularly surprising given that the Code of Ethics of one of the main homeopathy trade bodies, the Society of Homeopaths, who claim to represent 'professional homeopaths', have a clear requirement for their members to abide by ASA guidance:

All advertising must be published in a way that conforms to the law and to (the guidance issued in the British Code of Advertising Practice) [sic].

We can only hope that they will now start to take their responsibilities seriously and help ensure their members are not the subject of any further complaints.

In the ASA's email, they say they will be working with these organisations to ensure their members' websites comply with the CAP Code. It remains to be seen just how vigilant and thorough they and their members are. Given their past failings, there is not much to be optimistic about.

However, it goes without saying that those websites will be diligently monitored by others.

Latest ASA adjudications: 9 March 2011

The Advertising Standards Authority published five adjudications on 9 March 2011 that concern advertisers making health claims.

 

British Institute for Allergy and Environmental Therapy

Result: Upheld on all five points

BIAET had published a leaflet making claims about their 'Allergy Testing and Treatment' and the ASA asked them to substantiate those claims. They supplied some details of a 'trial' conducted by Glasgow Homeopathic Hospital. However, the ASA decided it did not meet their standards for substantiation, saying:

We noted the article on homeopathy provided by BIAET, but we also noted that the article was a general discussion and profile of homeopathy, and did not assess whether homeopathy could treat the symptoms of hay fever.

Because we considered we had not seen suitable evidence to substantiate the claims made by BIAET that their product could treat hay fever, we concluded that the ads were misleading.

Another part of the complaint was that the ad breached the Code because it implied that the treatment was safe merely because it was natural. The advertiser maintained:

They believed that the word natural would be understood by patients to be associated with homeopathy and herbalism. They considered the ad made clear that the product was natural because it did not have side effects and did not use chemical drugs.

The ASA took a different view:

We considered that consumers would understand the claim to imply that there were no side effects from taking the remedy because the remedy was natural, and that it was therefore safe to use. Because we considered the ad implied that the remedy was safe merely because it was natural, we concluded the ad breached the Code.

This is significant because many adverts for alternative health products make the implied or blatant claim that because their product is 'natural', it is inherently safe. This is clearly false.

arrowgreenRead the adjudication for full details.

 


Magno-Pulse Ltd

Result: Upheld on all six points

Magno-pulse advertised their knee support in the national press that had 'patented directional plates to reflect the heat back into the knee and to offer soothing support to gently relieve aches and painful areas' and mentioned various medical conditions and cited testimonials form 'satisfied' customers.

The advertiser withdrew the ad and did not supply any evidence to the ASA to substantiate the claims.

arrowgreenRead the adjudication for full details.

 


Metabolics Ltd

Result: Upheld on all four points

A leaflet for food supplements featured products called "Bright Eyes", "Colon Cleanse" and "Memory Recall".

Although a complainant challenged one of the claims being made, the ASA added three others. The advertiser agreed to remove the phrase "detoxifies the bowel" from future ads.

For their Memory Recall Formula, the advertiser argues that 'the ad did not make any health claims in relation to this product, or any claims that the product improved memory function'. The ASA disagreed with their interpretation and said that, because the advertiser had not provided evidence to substantiate the claim, it was misleading.

For the third issue, the advertiser said that it had been shown that age-related macular degeneration was in part caused by a deficiency of certain substances. Their product claimed to supply these substances. However, although the advertiser supplied some evidence, the ASA decided that:

Metabolics had not proved that a supplement containing these ingredients would be absorbed and utilised by the body in the same way as the ingredients in their naturally occurring states.

So, just because a condition may be caused by a deficiency of a chemical, supplying that chemical in a supplement does not necessarily mean that the condition will improve. Since the advertiser supplied no evidence to support the assertion that it could, the ASA upheld the complaint on this point.

The final issue was:

the heading "Is your eyesight deteriorating?" for the Bright Eyes product, implied a medicinal claim that the product could be used to prevent or cure deterioration of the eyes, and therefore required marketing authorisation from the MHRA.

The advertiser 'did not believe the heading "Is your eyesight deteriorating?" implied the product could help deterioration of the eyes'. The ASA considered

that most readers would understand from the question posed in the heading "Is your eyesight deteriorating?" that the product being advertised could help people whose eyesight was deteriorating.

Because we considered this was an unauthorised medicinal claim, we considered that the ad had breached the Code.

arrowgreenRead the adjudication for full details.

 


Natures Naturals Ltd

Result: Upheld on both points

This was a complaint about an email:

for Immuno-AID and Magnesium Oil Spray natural health products, stated "Immuno-AID™is a natural product formulated to provide the body with the components that modulate the immune system so that it is healthy, strong and in a constant state of readiness to protect us against pathogenic diseases created by viral and bacterial infections should they occur” and “Magnesium Oil Spray helps relieve the symptoms of Insomnia, Restless Leg Syndrom [sic], Night Cramps, Stress and Travel Fatigue, Reduces muscle spasms cramping and relaxes tired bodies”.

The complaint was about the name of the product being misleading and whether the advertiser could substantiate the claims made. Regarding the former of these, the advertiser stated that:

the Intellectual Property Office had approved the Immuno-AID trademark.

This did not convince the ASA:

We noted that the Intellectual Property Office had approved the Immuno-AID trademark, but did not consider the trademark to be evidence for the products efficacy.

For the second issue complained about, the advertiser supplied an article from the British Medical Journal:

British Medical Journal article found magnesium deficiency was present in approximately a quarter of patients with restless leg syndrome, it also stated "This is not the same as saying that everyone who has restless legs will benefit from magnesium".

Overall, the advertiser failed to provide scientific evidence that substantiated the claims they were making, so the complaint was upheld.

arrowgreenRead the adjudication for full details.

 


Rodial Ltd

Result: Upheld on both points

The ad was an email offering a weight loss aid that stated:

"BEAT THE BLOAT THIS Christmas. TUMMY TUCK STICKS, £48".

A complainant challenged the efficacy claims and the ASA challenged whether:

"Tummy Tuck Sticks" misleadingly implied that the product could achieve weight loss from a specific area of the body.

In an attempt to substantiate their claims, the advertiser supplied the ASA with an information sheet about the ingredients and their properties. However, the ASA did not consider this to be the 'robust, scientific evidence, such as clinical trials conducted on people' required to substantiate those claims, so they concluded that the ad was misleading.

The ASA noted that the CAP Code stated that ads should not contain claims that weight or fat can be lost from specific parts of the body and they considered that the name of the product itself was an implied claim to this effect and therefore considered that the ad breached the Code.

There is a problem here because the product name appears to be a registered trade mark:

Because we understood the name "Tummy Tuck Sticks" was a registered trade mark, we told Rodial to include a disclaimer in future ads that made clear that the product had not been proven to aid weight loss from the stomach.

So, we should expect to see this disclaimer on all marketing communications for this product from Rodial from now on.

arrowgreenRead the adjudication for full details.

Response to MHRA consultation on homeopathy

19 February 2011

The Medicines and Healthcare products Regulatory Agency (MHRA) consulted the public on several aspects of their regulation of homeopathic products.

This consultation was prompted by the Government’s response to the House of Commons Science and Technology Committee report ‘Evidence Check 2: Homeopathy. The public meetings that the Committee held can be viewed online:

Session 1

Session 2

The Committee's report contains a full transcript of these sessions, along with all written submissions.

In its response, the Government asked the MHRA to look at several issues raised by the Report and this resulted in the MHRA's consultation:

Review of Medicines Act 1968: Informal consultation on issues relating to the product licences of right (PLR) regime and homeopathy

There are several issues the MHRA are tackling with this consultation:

  1. The complete abolition of PLRs for homeopathic products, proposed for April 2013.
  2. The complete removal of all PLRs for Bach flower products.
  3. The complete removal of all PLRs for anthroposophic products.
  4. The abolition of the Non Orthodox Practitioner scheme.
  5. The mandatory wording used on products licensed under the NRS

The consultation ended on 18 February 2011 and the Nightingale Collaboration submitted a response.

The summary of our recomendations is:

  • To protect the public, homeopathic products should be properly defined.
  • All PLRs should be revoked at the earliest opportunity.
  • The normal fees for the transfer of PLRs to other licence categories should be charged to the manufacturers, saving the MHRA some £250,000 to £700,000.
  • The warning labels on all homeopathic products should be revised so that the public have the information necessary to make fully informed choices.

To find out more, please read the full submission.

Announcement

Misinformation about complementary and alternative therapies is rife on the Internet, in newspapers and magazines and on the high street and this misinformation misleads the public. It is particularly important that the public have accurate information about healthcare so they can make informed choices.

This misleading information won't disappear by itself: it needs to be challenged.

Complaints about chiropractors' website claims, made by Alan Henness, Simon Perry and others, have shown that it is possible to confront and highlight misleading information, have it withdrawn and those responsible held to account.

The Nightingale Collaboration will continue this work and will share knowledge and best practice with others and give them support and encouragement.

Florence Nightingale is well known for her commitment to using robust evidence to decide what worked in improving healthcare. As the first woman to be elected to the Royal Statistical Society and on the centenary of her death in 1910, the Nightingale Collaboration acknowledges her great legacy.

Aims

The Nightingale Collaboration will work to improve the protection of the public by ensuring claims made about complementary and alternative therapies are not misleading. We will do this by:

  • challenging misleading claims made by practitioners on their websites, in adverts and in their promotional and sales materials and subjecting these to scrutiny by the appropriate regulatory bodies;
  • striving to ensure that organisations representing complementary and alternative practitioners have robust codes of conduct for their members that protect the public and that these are rigorously enforced.

Methods

There are several different methods of working that will be used to achieve the Aims:

A. Nightingale Collaboration Campaigns: conducted by Nightingale Collaboration personnel, gathering information, planning and executing the campaign, with the support of volunteers where required. This type of campaign would clearly be carried out in the name of the Nightingale Collaboration.

B. Associated Campaigns: we will collaborate with volunteers on campaigns by providing advice and guidance to ensure maximum impact and probability of success. These campaigns will be publicised as being conducted in association with the Nightingale Collaboration.

C. The Nightingale Collaboration will make tools and resources available so that others can pursue their own individual campaigns with maximum effect. These campaigns will be entirely separate from the Nightingale Collaboration.

Volunteer Collaboration

Volunteer roles

There will be differing roles for volunteers, allowing for varying levels of commitment. Volunteers will be able to contribute according to their skills and whatever time commitment suits them.

It will be very much a collaborative effort.

Possible tasks include:

1. Locating misleading information, whether that is on the Internet, in national or local press, in local clinics, etc.

2. Gathering this misleading information in a legal and diligent manner.

3. Coordinating local campaigns.

4. Submitting complaints to the appropriate regulatory bodies.

Volunteer training

The Nightingale Collaboration will provide training for key volunteers to help them in their roles.

Tools and resources

There will be Nightingale Collaboration tools, resources, advice and guidance available to volunteers, some of which will also be publicly available to anyone who wants to act wholly independently.

Code of Conduct

There will be a code of conduct on how we obtain information and how we deal with others so we maintain the moral high ground and keep within the law. All personnel and volunteers will be required to abide by it.

Experts

We will have access to various experts who can advise us on legal matters and supply authoritative advice on scientific evidence to use in our campaigns.

The Nightingale Collaboration

The Nightingale Collaboration must be seen to be ethical, legal, authoritative, thorough and tenacious. This is so that we attract good volunteers and so that the Nightingale Collaboration is taken seriously — providers of misinformation must be clearly aware that we mean business. We must gain a reputation for effectiveness.

More information will be released on the website over the coming weeks and months. To be kept informed, please subscribe to our Newsletter and follow @NightingaleC on Twitter.

Alan Henness & Maria MacLachlan

Directors, The Nightingale Collaboration

October 2010

Gravityscan Badge

Newsletter

To subscribe to our Newsletter, enter your details below and click Subscribe.
You will receive a confirmation email. Please click on the link in the email to confirm your subscription.