Challenging misleading healthcare claims

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We need your help!

The new Government register could be a way for unproven and disproven therapies to gain undeserved recognition. Help us make sure it's not abused.

not_accredited

Last time, we mentioned the consultation by the Council for Healthcare Regulatory Excellence (CHRE) on their Accredited Register scheme that will be launched in November. This scheme 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 list of organisations that have expressed an interest is growing and comprises many well-respected medical professions such as Cardiothoracic Surgical Assistants, Genetic Nurses and Counsellors and Anaesthesia Assistants.

Yet there are others, including homeopaths, acupuncturists, osteomyologists, anthroposophists, naturopaths, reiki-ists and even crystal healers. On top of that, there are several organisations that register alternative therapists of all flavours, including reflexologists, aromatherapists, bowen therapists, ear candlers, kinesiologists, stone therapists — just about the whole gamut of alternative therapists.

And, of course, the Complementary and Natural Healthcare Council (CNHC).

We don't know what the CHRE's attitude to alternative therapy organisations is, but we can easily see how alternative therapists, if they were to become CHRE accredited and entitled to display the Accredited Register's 'quality mark', could easily trumpet the accreditation and the mark as a symbol of legitimacy.

This does not enhance the protection of the public because it will simply confound informed consumer choice.

When is endorsement not endorsement?

The CHRE say that all they are doing is ensuring those organisations are committed to good practice in the way they operate. But even the best run register of practitioners of an unproven alternative therapy still leaves its members practising that unproven therapy on an unsuspecting public.

Also, since the idea is to have the registers online on the CHRE's website, they aim to make it easier for consumers to find practitioners.

However, they are at pains to point out that:

It will not be an endorsement of the therapeutic validity or effectiveness of any particular discipline or treatment.

But there is nothing in the draft standards that obliges organisations or their members to make this absolutely clear to their prospective customers.

Is it possible to endorse a register of practitioners of unproven therapies without being seen to endorse that unproven therapy?

We don't think so. And that is why this proposal is so dangerous.

Even if it is made clear, we believe it will not serve to protect the public. On the contrary, we believe being accredited by the CHRE — a statutory Government body — will simply and inevitably mislead the public.

Maintaining standards

Some of the proposed eligibility criteria and standards are interesting. To be eligible, an organisation must be able to:

…demonstrate that there either is a sound knowledge base underpinning the profession or it is developing one and makes that explicit to the public. (A.7)

There are some obvious problems with this. The first is that it talks about a 'knowledge base' but not an 'evidence base'. Homeopaths (or whoever) may well believe there to be a 'sound knowledge base' for their therapy, but it is really a scientifically unsound knowledge base. The danger here is that we don't know how the CHRE might want to interpret this criterion; we don't know if they will be disposed to allowing homeopathy to pass this test, so we have to make sure that this criterion is made far more robust.

But if a profession is just developing this sound knowledge base (and no doubt some alternative therapists might claim that), the question has to be asked how consumers can possibly be protected when subjected to a treatment by practitioners who haven't even yet got that 'sound knowledge base'?

One of the standards an organisation has to meet is:

C.2 The organisation promotes ethical practice

When it comes to unproven or disproven alternative therapies such as homeopathy, reiki and crystal healing, it cannot be ethical to subject a customer to these 'treatments', telling them it will align their chakras, balance your Qi, remove negative energy, that it's an 'energy' medicine that works holistically with your body's innate healing or that it works because of 'laws' invented 200 years ago, but which are entirely contrary to everything else we know about physics, chemistry and biology. Will they tell them there is no good evidence that it will help them?

Within the confines of the homeopathic, reiki or other make-believe 'paradigm', we have to worry that the CHRE might be tempted to accept that these are just different 'modalities'; different ways of looking at the body and different ways of healing, when they are all just pseudo scientific nonsense.

If the CHRE is to genuinely protect the consumer — and seen to be doing so — all such post-modern nonsense must be given short shrift and we need to ensure the CHRE have robust standards in place to rule out the possibility of alternative therapies ever being given the credibility that being CHRE-accredited will confer on them.

Another standard:

G.1 The organisation provides clear, helpful, easy to access information. It ensures that information provided by the organisation and by its registrants helps consumers to make informed choices and exercise informed consent.

An alternative therapy trade body may well provide clear, helpful and easy to access information, but is it credible to believe they will give their customers the information necessary for them to make truly informed decisions? Will they tell them it's not been independently tested and that there is no good reason to believe it can help/treat/cure/alleviate their condition?

Aims

One thing that must be remembered is that the CHRE aims:

…to promote the health, safety and well-being of patients and other members of the public and to be a strong, independent voice for patients in the regulation of health professionals throughout the UK.

They can't do this if they allow alternative therapies to hitch a ride and gain undeserved credibility; they need to protect patients and be seen to protect patients.

 

We've picked out just a few of the problems with the proposed standards, but there are many more that, depending on how they are interpreted, could allow many pseudo scientific, unproven or disproven therapies to be unleashed onto an unsuspecting public with the false imprimatur of Government accreditation.

What we need our supporters to do

fence

We need you to make your voice heard and make the CHRE aware of your concerns about allowing alternative therapists into the Accredited Register scheme.

We would urge you to submit a full response to the CHRE, replying to all the criteria and standards you think need to be strengthened.

Alternatively, complete the survey the CHRE have helpfully provided that has the eight questions the consultation is seeking responses on or submit the questionnaire included in the consultation document and send it to them by email or post.

But if you don't have time for that, please just drop the CHRE This email address is being protected from spambots. You need JavaScript enabled to view it., saying that you think alternative therapists should not be allowed onto the Accredited Register, ideally giving brief reasons why.

If you do submit a response, please let us know, but remember the deadline for submissions to the CHRE is Tuesday 10 July 2012.

Your help is greatly appreciated!

14 June 2012

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.

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