Challenging misleading healthcare claims

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Regulation of health care professionals

Thirty-one different health professions consisting of over 1.4 million professionals (from medical doctors and nurses to osteopaths and chiropractors) are currently statutorily regulated and overseen by ten regulatory bodies:

collage…the regulators operate within a wide variety of legal frameworks which have been agreed and amended by Parliament in different ways and at different times over the past 150 years. A complex legislative landscape has evolved on a piecemeal basis resulting in a wide range of idiosyncrasies and inconsistency in the powers, duties and responsibilities of each of the regulators. There are currently seven separate Acts of Parliament and three Orders made under section 60 of the Health Act 1999 which govern 10 regulatory bodies. These have all been amended extensively by 16 Orders made under the Health Act 1999 and a range of Acts of Parliament over the last 10 years.

In essence, it's a nightmare to administer, confusing to the public and the Department of Health wants to simplify this tangled mess.

So, the Law Commission, the Scottish Law Commission and the Northern Ireland Law Commission published a joint consultation setting out their proposals to consolidate the various Acts and Orders into one, with variations for different regulators only where necessary.

But note that this is simply consolidating the regulations, not the regulators themselves so there was no direct proposal to merge or abandon any of the regulators. However, having regulators all set up under the one common Act may well make merging some of them easier in the future.

The lengthy consultation document covered numerous aspects of the current regulations and how the Law Commissioners proposed to tackle them. It also asked for views on several key questions.

There are many differences between the regulators in what their duties are, the way they are constituted, the requirements they place on their registrants and the way they run complaints and fitness to practice panels.

We took the opportunity to make recommendations on some aspects as they applied to chiropractors and osteopaths.

The consultation ended last Thursday and the Council for Healthcare Regulatory Excellence has published their response. You can read our response here.

And another one…

accreditedThere's another consultation currently in progress that interests us.

The Council for Healthcare Regulatory Excellence (CHRE) — to be renamed the Professional Standards Authority for Health and Social Care in November — is setting up a register of registers.

The CHRE's new duty to set up this register was part of the Health and Social Care Act 2012 and it will:

…set standards for organisations that hold voluntary registers for people working in health and social care occupations and we will accredit the register if they meet those standards. It will then be known as an 'Accredited Register'.

The CHRE is the 'regulator of regulators' who:

…scrutinise and oversee the work of the nine regulatory bodies that set standards for training and conduct of health professionals.

The nine regulators are the ones the Law Commissioners are wanting to bring together under one Act.

Sixty-six organisations and trade bodies that have a register of health professionals have already expressed an interest in this accreditation scheme but this includes homeopaths, crystal healers, reiki practitioners, acupuncturists, anthroposophists and various organisations that cover a variety of alternative therapies.

Even the Complementary and Natural Healthcare Council are interested in the scheme.

Of course, an organisation accepted by the CHRE will be able to say that their register is accredited by the CHRE and some may even claim to be accredited or even regulated by the Government. Members of those registers would also be able to display a 'quality mark' to show they are part of this Government scheme.

There are standards that will have to be met, but it is not clear that these standards and the eligibility requirements are rigorous enough to prevent it being taken advantage of by practitioners of therapies for which there is not a jot of evidence.

We believe that being a CHRE Accredited Register will lend unearned and undeserved legitimacy to many alternative therapies — this can only mislead the public.

Further details of the consultation can be found on the CHRE's website.

We will be submitting our own response but we encourage our supporters to let the CHRE know their own views.

The CHRE have made this easy by providing a short online survey of the eight questions the consultation is seeking responses on and we strongly encourage our supporters to complete this or submit the questionnaire included in the consultation document and send it to them by email or post.

The closing date for your response is 10 July 2012 and we'll publish our response once we've submitted it.

03 June 2012

Homeopathy clinic toes the line

Tagetes ErectaA complaint submitted to the Advertising Standards Authority (ASA) 17 months ago has finally been resolved.

A leaflet entitled, Podiatry & Chiropody Marigold Clinic, found in the 'pharmacy' area of the Royal London Hospital for Integrated Medicine (RLHIM) — previously named the Royal London Homeopathic Hospital — claimed that:

Marigold Therapy is a research based medicine which provides gentle, effective treatment for foot problems.

Marigold Therapy is an integral part of homeopathic podiatry, comprising of specially formulated medication applied topically in conjunction with conventional podiatry treatment.

We understood from this that conditions were treated by topical treatments (creams or ointments) called 'Marigold Therapy' and this was confirmed by the Marigold Therapy website (cached), which points out that Marigold Therapy refers to a range of products that have been:

researched and developed over the past 35 years

…by Dr M Taufiq Khan who founded the RLHIM's Marigold Clinic in the early nineties. The family tradition continues with M Taufiq Khan's son, M Tariq Khan, now Director and Consultant Podiatrist (cached) at the clinic.

The RLHIM leaflet listed conditions treated at their Marigold Clinic (cached):

The Marigold Clinic specialises in the treatment of foot disorders including:

Skin

  • Athlete's foot
  • Corns, Callosities and Fissures
  • Chilblains
  • Dry eczema
  • Skin ulcers
  • Verrucae and Viral Warts
  • Epidermolysis Bullosa
  • Pachyonychia Congenita

Bones and joints

  • Bunion and other bone and joint conditions including gout
  • Post-operative complications
  • Sports injuries involving the feet

Nails

  • Thickened, dry, brittle, psoriatic and eczematic nails
  • Fungal infection

The Marigold Therapy website claims that:

the safety and efficacy of Marigold Therapy have been demonstrated through extensive clinical use in podiatry clinics and numerous studies and in randomised, double blind, placebo controlled trials

…but no references are given for any of these studies and simply lists three locations where these studies were allegedly conducted.

For this reason, we complained about the RLHIM leaflet to the ASA, challenging whether the efficacy claims made for Marigold Therapy to treat the medical conditions listed could be substantiated. When we did so, we pointed out that this leaflet was also available as a pdf download and in their 'interactive hospital service guide', though this was several months before the ASA extended its digital remit to include marketers' own websites.

It should have been a simple matter for the RHLIM or Tariq Khan to provide copies of the 'randomised, double-blind, placebo-controlled trials demonstrating the safety and efficacy of Marigold Therapy' as claimed for it on the Marigold Therapy website. In fact, he helpfully lists some studies he's co-written on the RHLIM's website: of the eleven listed, two specifically mention marigold therapy, five mention thuja and all but one are co-written by father and son. It's not clear whether these studies are the 'numerous' ones referred to nor whether the journals they are published in are peer reviewed.

After 17 months, the RLHIM has agreed with the ASA that the leaflet must be withdrawn and changes made before it is used again. So, instead of an adjudication, the University College London Hospitals — trading as The Royal London Hospital for Integrated Medicine — just get a mention in the ASA's list of informally resolved cases.

But what's important is that the leaflet with its misleading claims has now been removed from their website and pages 36 and 37 of the latest RLHIM service guide are no longer there.

Loose ends

Even though the misleading leaflet has had to be withdrawn, there are quite a few loose ends here and we hope to return to this at a later date, but you might like to read more about the Marigold Clinic in a blog post written by Prof David Colquhoun a few years ago: Conflicts of Interest at the Homeopathic Hospital.

Then there are all the other leaflets about the other treatments on offer at the RHLIM…but those will have to keep for later.

Red Tape Challenge response

paperworkThanks to all 190 of our supporters who responded to our Red Tape Challenge Survey!

This fantastic response helped us formulate our reply to the Red Tape Challenge and we were able to include many of your comments.

You can download a pdf of our full response here.

'Right-touch' regulation

It is clear that it is highly misleading for the medicines regulator to be lending legitimacy to homeopathic non-medicines. Unfortunately, regulation of homeopathic 'medicines' is mandated by EU Directives, but we can see no need for these to be regulated by the medicines regulator. We have recommended that the Government review 'right-touch' regulation of these products and asked that they consider a more appropriate body.

It is also clear that current regulation is not working to protect the public because it allows the labelling of homeopathic products to mislead consumers. We have recommended that this be reviewed so that consumers are able to make fully informed choices.

Double standards

When it comes to the regulation of herbal products, the situation is more complicated because some traditional herbal products can have pharmacological effects and can interfere with conventional medicines. It is appropriate that some measure of protection is afforded to consumers by good and effective regulation.

yellownote1However, the current regulations do not work to protect the consumer because of the double standard of the lax herbal regulation compared to the far more stringent Marketing Authorisation required by conventional medicines: herbal products are not required to demonstrate efficacy and the current regulations are certanly not burdensome. We have recommended that the Government looks at more appropriate regulation.

Like the labelling of homeopathic products, the labelling required by the traditional herbal regulations also does not work to allow consumers to make informed choices.

 

For further details, please read our full response.

 

Thanks again for all your support.

Red Tape Challenge Survey deadline extended

herbalpillsWe've had a great response to our Red Tape Challenge Survey on the regulation of homeopathic and traditional herbal products, despite the initial technical hitch!

Thanks to all our supporters who have completed the survey and given us their views — they will help us formulate our response to the Government's Red Tape Challenge.

Although the deadline for the Government's Challenge ends on 12 April, there is still time for more of our supporters to complete our survey so we're keeping the survey open until midnight on Tuesday 10 April.

Unfortunately, these consultations are frequently a bit of a numbers game, with weight given to quantity rather than quality when decisions should clearly be made on the strength of the evidence and argument, so if you are one of our supporters, make sure your voice is heard by completing our survey now.

Individual responses

But we also need as many supporters as possible to submit their individual views. We know you are all capable of it, so why not take some time out this holiday weekend and tell the Government what you think of the regulation of homeopathic and traditional herbal products?

You can do this by responding on the web pages for homeopathic products or traditional herbal products, perhaps challenging some of the views expressed there.

Alternatively, you can submit your response directly to the Red Tape Challenge.

Thanks again for all your support.

Our Red Tape Challenge Survey has now closed.

Thanks to all our supporters who contributed.

Red Tape Challenge

regulated

We need your help!

We are canvassing the views of our supporters so we can respond to the Government's Red Tape Challenge — they are looking at a lot of regulations, but the current focus is on medicines' legislation. The public are being asked:

…which regulations are working and which are not; what should be scrapped, what should be saved and what should be simplified.

We're particularly interested in the regulations surrounding homeopathic and herbal products.

For homeopathy, the regulation by the medicines' regulator the MHRA confers a degree of legitimacy onto products that have no robust evidence of efficacy. So, do you, our supporters, think the current regulation is a good idea? Are the labelling requirements misleading? Could these regulations be simplified or scrapped altogether?

Herbal products are different because they do contain potentially pharmacologically active ingredients. A case can be made for good regulation of them so that at least some measure of protection is afforded to the public. But since no evidence of efficacy is required for MHRA registration of traditional herbal products, does this regulation mislead more than it protects? If they are pharmacologically active, should they be regulated in the same stringent ways that pharmaceutical products are regulated? Or does the two-tier system provide acceptable protection to the public? Is the regulation onerous or is it essential protection to the public?

More information about each of these is given in our short survey.

Because responses to the Government's Red Tape Challenge have to be in by Thursday 12 April, we need our supporters to take our survey by Thursday 5 April — please take a few minutes now to complete it to give us time to analyse the results and finalise our submission.

We also urge you to submit your own response, sending it directly to the Red Tape Challenge — it's important to ensure your views are heard and taken into account by the Government.

If you are one of our supporters, please complete our Red Tape Challenge Survey.

Our Red Tape Challenge Survey has now closed.

Thanks to all our supporters who contributed.

Campaign News: January 2012

Misleading reflexology claims still not removed

Happy New Year!

We begin with an update of the Tamsin Marshall reflexology website we reported on in a previous newsletter.

This was one of the three websites for our master complaint on reflexology to the ASA. Although the website changed before the ASA's adjudication was published — removing a reference to cancer — many of the misleading claims we complained about remained (see right).

We are pleased to see that this list of misleading claims has finally been removed.

reflexology_claims

However, it's disappointing to see many of these claims are still there (cached) in a slightly different form:

Do you suffer from insomnia or fatigue? Are you prone to recurrent infections, mild or chronic illnesses? Are you trying for a baby, or currently pregnant? Are you suffering from hormonal imbalances or thyroid problems? If so, Reflexology may be just what you and your body needs.

If you would like to discuss your treatment or make an appointment please email.

And here (cached):

Reflexology encourages and supports the body in its own healing process, as well as improving blood circulation, assisting in the removal of toxins, inducing relaxation and restoring balance to organs and glands.

It is widely acknowledged that Reflexology is effective not only in helping the body to heal, but also as a source of preventative health care and improved physical fitness. By supporting the mind and body, Reflexology encourages optimum health.

Since these are virtually identical to the claims the ASA ruled were misleading, it looks like this reflexologist still has a lot of changes to make to comply with the adjudication against her. We have informed the ASA.

Ensuring compliance

There can't be many people who believe there is no need for an advertising regulator. A quick glance through the ASA's adjudications gives an indication of what it might be like if there was a free-for-all. Should advertisers of double glazing, car insurance, washing powder, weight-loss diets or penis enlargements be free to claim whatever they like about their product or service? Are exaggerations, half-truths and downright lies acceptable?

No, there needs to be effective regulation that protects the public from the excesses of the marketing machine.

There are several possible models for regulation including one set up under legislation with legal powers to ensure and enforce compliance. However, the ASA is set up as a non-statutory regulator:

We are independent of both the Government and the advertising industry…

They are, of course, funded by a levy on advertisers. How else could they be funded? Who else would be willing to pay for the essential work they do?

Advertisers can choose to pay this levy, but they cannot choose to comply with the Advertising Codes or the ASA's rulings — compliance is mandatory.

However, finance is raised by arm's-length boards (one for broadcast and one for non-broadcast) so that those who investigate and adjudicate on advertising are completely unaware of who has provided the funding.

That separation gives them the necessary independence and authority.

Their job is to:

…make sure all advertisements are legal, decent, honest and truthful.

Very simple requirements; and ones that the public has a right to expect in all advertising, regardless of what it's for or where it appears.

But even though the ASA is a non-statutory body, it has considerable weight — a point that would appear to need highlighting to some CAM advertisers, some of whom have even proclaimed that there is no need to comply with the ASA's CAP Code and advise others to ignore any letter from the ASA. Some have even involved their lawyers.

The ASA outlines the strong basis for their authority:

Interaction with the law

Across the European Union (EU) there is a unified piece of consumer protection legislation to prevent the use of misleading or unfair trading practices. This law, called the Unfair Commercial Practices Directive, has been translated into UK law to make sure that we have the same rules as all the other countries in the EU.

The ASA works within this legal framework to make sure that UK advertising is not misleading or unfair. The ASA is able to refer advertisers who refuse to work with us and persistently make misleading claims to the Office of Fair Trading (OFT) for legal action. The OFT is able to act under 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 govern how businesses advertise to each other.

The ASA is considered the ‘established means’ for gaining compliance with both these pieces of legislation. 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. The ASA is able to take action quickly and this avoids clogging up our court system.

Referral is rarely necessary, as most advertisers prefer to work with the self-regulatory system. Since 2000 around thirty advertisers have been referred to the OFT; in the same period the ASA has dealt with around 200,000 complaints.

In a nutshell: the vast majority of advertisers are responsible and work with the ASA, but the ASA have the option and authority to take strong action should that prove necessary.

Alternative regulation?

The Alliance for Natural Healthcare (a pressure group of herbal and supplement manufacturers, retailers and supporters) recently pronounced:

…the CAM community don’t regard the dissemination of information that relates to their practice as ‘marketing’ in the way interpreted by the ASA.

hurdle

That so many CAM practitioners have responded positively to complaints would suggest there are many in the CAM 'community' who would disagree with this generalisation and who realise that to be socially and ethically responsible, they have to abide by the ASA's rules.

However, other CAM practitioners demand that they be considered a special case; that they shouldn't be regulated to the same set of rules as everyone else.

To accept a lower hurdle for CAM would put the public in even more danger of being misled. Indeed, because of the possible effects on our health and wellbeing, a case could be made for a higher level for healthcare claims.

Responsible advertising

The ASA only demands that claims about CAM meet the same evidential requirements as all other advertisers. No special pleading is allowed because they think they work in some alternative paradigm.

It's clear that there are many CAM practitioners who agree that advertising should be legal, decent, honest and truthful and that advertising rules must be applied equally and fairly to all adverts — whatever they are for.

That is all the Nightingale Collaboration is seeking.

Sanctions

In addition to their existing sanctions, on-line advertisers who have failed to abide by the ASA's adjudications can be listed on their Non-compliant online advertisers page. However, they also have other sanctions available to them including:

  • Removal of paid-for search advertising — ads that link to the page hosting the non-compliant marketing communication may be removed with the agreement of the search engines.
  • ASA paid-for search advertisements — the ASA could place advertisements online highlighting an advertiser's continued non-compliance.

Since the ASA's agreements with search engines include Google, advertisers should not underestimate the effect these might have on visitors to their website.

Named and shamed

Five out of the 14 advertisers currently highlighted on their Non-compliant online advertisers page fall into the alternative therapy category and include one advertising detox foot pads, two advertising reiki and one advertising liquid chlorophyll. The latest additions include Ionic Balance and an 'osteomyologist'.

Ionic Balance were advertising a plastic bracelet, promising all sorts of medical benefits, saying it produced 'negative ions, far infrared rays [heat] and alpha waves'. It would require a source of power to produce any of those and there is no evidence that, even if it did emit these, it had the benefits claimed for it.

The osteomyologist, Back Trouble UK, claimed they could treat:

whiplash and arthritis and be effective for migraine, headaches, period pains, behavioural problems in children, diabetes, stress, asthma, glue ear, colic in babies, sleep disturbance, strokes and other neurological problems

These bear more than a passing resemblance to the types of medical conditions that some chiropractors and osteopaths have claimed. Many chiropractors have removed lots of claims — although there are still far too many questionable claims — so perhaps it's time for the osteomyologists to fall in line and abide by the rules?

Legal aid

As part of our plans for the coming year, we could do with some legal help. We need a lawyer who either already knows all about the Consumer Protection from Unfair Trading Regulations 2008 or who is willing to become familiar with them.

If you can help or know someone who might be able to assist us, please contact us.

06 January 2012

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