Saturday, 13 May 2017

Homeopathy and Autism - Ireland - Part One

There are a surprising number of homeopaths in Ireland who offer CEASE therapy. CEASE therapy is equally as problematic there as it is the UK. Also, Ireland seems to be suffering more than the UK from the activities of anti-vaccination groups. Some members of these groups engage in dubious tactics. As the arguments are largely the same as for the UK, reading previous posts will be of help.

Medicines Regulation
Medicines regulation in Ireland was covered in a previous post. As in the UK, there are questions about the legal supply of unregistered homeopathic medicines to lay homeopaths and supply by them to clients.

Irish Society of Homeopaths
They say -
We are the voice of homeopathy in Ireland, with a specially trained media team and spokespeople who deal with the media on our behalf. Also, as CAM therapies are self-regulating, the Irish Society of Homeopaths is the regulating body for homeopaths in Ireland.
This is a different situation from the UK the UK SoH is one of a number of trade bodies whilst the ISoH would appear to be the only one in Ireland. The ISoH has a Code of Ethics but what is interesting is the statement that "We take our Code of Ethics very seriously and every member signs a contract to abide by the Code at all times." In terms of elements of the Code that are of particular interest...

1.15 Practise only within the boundaries of their own competence 
1.16 Respond promptly and constructively to concerns, criticisms and complaints  
1.17 Respect the skills of other health care professionals and where possible work in co-operation with them  
1.18 Never disparage or speak disrespectfully of fellow Homeopaths, either in public or to patients  
1.19 Comply with current legislation of the country.  
1.20 Practice in accordance with this code and any other codes or documents as agreed by the committee of the ISH  
1.21 Advise the Professional Conduct Officer if a situation arises that may result in a complaint being made against them
As CEASE therapy etc often involve nutritional supplements -
2.6.1 Where members offer other complementary therapies, they must inform the patient prior to treatment about the other therapy and indicate their relevant qualifications, registration with the relevant registering body and adherence to a separate Code of Conduct. They should be very clear that this therapy is not Homeopathy. 
2.6.2 They must receive permission from the patient to perform this other treatment on the patient and record such consent in the patient notes
In theory, this would require ISoH to also be registered with the Nutritional Therapists of Ireland
3.1.1 Members are required to comply with the criminal and relevant civil law of the country, state or territory where they are practising  
3.1.2 Members must observe and keep up to date with all legislation and regulations relating directly or indirectly to the practice of homeopathy  
3.1.3 References to any legislation or regulations throughout this code shall include any amendments or other alterations, repeals or replacements made in law since the date they came into force. Any reference to the singular shall include the plural and references to the feminine shall include the masculine.
 This would include consumer protection legislation as well as medicines regulation.
2.14.1 Homeopaths who do not have full conventional medical training are not qualified to make a medical diagnosis 
2.14.2 Members will be aware of the limits of their professional competence and where appropriate will refer to other practitioners or health care professionals where: 
a) The case is beyond their clinical competence b) Where a patient would benefit from another form of treatment c) The patient exhibits symptoms that suggests an underlying condition which requires further investigation and medical diagnosis
Would the prohibit on making a diagnosis include making claims about the "underlying causes" of ASD? Would it include making statements about "vaccine damage"? Lay homeopaths in many countries seem to have problems with identifying the limits of their competence.

3.4.1 Members should ensure that they do not allow misleading advertising and information about their practice. Advertising should be ‘legal, decent, honest and truthful’ as defined by the Advertising Standards Authority for Ireland  
3.4.2 Professional advertising and marketing communications: 
a) Must be factual and not seek to mislead or deceive or make unrealistic or extravagant claims b) May indicate special interests but must not make claims of superiority or disparage professional colleagues or other professionals c) Make no promise of cure, either implicit or explicit, of any named disease d) All research should be presented clearly honestly and without distortion; all speculative theories will be stated as such and clearly distinguished 
3.4.3. Advertising content and the way it is distributed must not put prospective patients under pressure to consult or seek treatment from a member
Speculative theories will be clearly distinguished? CEASE therapy etc are not just based on speculative theories, they are based on discredited theories. The very phrase "Complete Elimination of Autism Spectrum Expression" is an implied cure. Anti-vaccination discussion often involves disparagement of professionals.

Advertising Standards Authority for Ireland
The ASAI are the advertising self-regulator. As the per the UK ASA, its function is partly one of dealing with problematic advertising without the need for expensive and time consuming legal action. Whilst the ASAI do not enforce consumer protection law, their Code can be understood as an accepted interpretation of consumer protection law and other industry specific law that affects advertising.

The particularly relevant parts of the Code include -
(h) A claim can be direct or implied, written, verbal or visual. The name of a product can constitute a claim.
This is particularly important in the case of CEASE therapy.
Advertisers have primary responsibility for ensuring that their marketing communications are in conformity with the law. A marketing communication should not contain anything that breaks the law or incites anyone to break it, nor omit anything that the law requires. The determination as to whether or not a marketing communication is legal is a matter for the courts or other appropriate regulatory authorities.

Advertisers should not state or imply that a product can legally be sold if it cannot. It is not a matter, however, for the ASAI to determine whether a product can or cannot be legally sold in Ireland.
Medicines regulations make the sale of certain products illegal, well, outside of limited situations.
Fear and Distress 
3.23A marketing communication should not cause fear or distress without good reason, such as for example, the encouragement of prudent behaviour or the discouragement of dangerous or ill-advised actions. In such cases, the fear aroused should not be disproportionate to the risk.
The anti-vaccination messages that go along with CEASE therapy etc could well fall foul of this provision.
A marketing communication should not mislead, or be likely to mislead, by inaccuracy, ambiguity, exaggeration, omission or otherwise.

Obvious untruths, exaggeration (“puffery”) or deliberate hyperbole that are unlikely to mislead, incidental minor inaccuracies and unorthodox spellings are not necessarily in conflict with the Code provided they do not affect the accuracy or perception of the marketing communication in any material way.

Claims such as “up to” and “from” should not exaggerate the value or the range of benefits likely to be achieved in practice by consumers. 
Advertisers should not exploit the credulity, inexperience or lack of knowledge of consumers.

The design and presentation of marketing communications should allow them to be easily and clearly understood.

Disclaimers, asterisked, footnoted or “small print” information should not contradict more prominent aspects of the message. Such information should be of sufficient size and/or prominence and be located and presented in such a manner as to be clearly and easily legible and/or audible; where appropriate such information should be linked to the relevant part of the main copy.

Whether the presentation of information is insufficient or likely to mislead depends on the context, the medium and, if the medium of the marketing communication is constrained by time or space, the measures that the advertiser takes to make that information available to the consumer by other reasonably accessible means. 
Matters of Opinion 
Advertisers may state an opinion about the quality or desirability of a product provided that it is clear that what they are expressing is their own opinion rather than a matter of fact and there is no likelihood of consumers being misled about any matter that is capable of objective assessment. Assertions or comparisons that go beyond subjective opinions should be capable of substantiation. 
A marketing communication should not contain claims – whether direct or indirect, expressed or implied – which a consumer would be likely to regard as being objectively true unless the objective truth of the claims canbe substantiated.

Before offering a marketing communication for publication, advertisers should satisfy themselves that they will be able to provide documentary evidence to substantiate all claims that consumers are likely to regard as objective. Relevant evidence should be sent without delay if requested by the ASAI and should be adequate to support both detailed claims and the overall impression created by the marketing communication.

If there is a significant division of informed opinion about any claim made in a marketing communication, the claim should not be portrayed as universally accepted.

Marketing communications should not present statistics in such a way as to exaggerate the validity of an advertising claim nor give the unjustified impression that there is validity to the claim.

Marketing communications should not:(a) misuse, mischaracterise or misleadingly cite any technical data, e.g. research results or quotations from technical and scientific publications;or(b) use scientific terminology or vocabulary in such a way as to suggest falsely or misleadingly that an advertising claim has scientific validity.

Marketing communications should not exaggerate the value, accuracy or usefulness of claims contained in books, tapes, videos, DVDs and the like that have not been independently substantiated.
This is all very clear. Claims for CEASE therapy etc would fall foul of them.

The section on Health and Beauty is too long to reproduce in full but is worth reading in full. The key issues are those of substantiation, discouragement of medical treatment, claims to cure and also the professional status of a practitioner. Interestingly,
11.17Marketing communications for medicinal products should not contain any offer to diagnose, advise, prescribe or treat by correspondence (correspondence includes by phone, post, internet, email and fax).
prohibits the offer to "treat" in any other than a face-to-face context. It is certainly the case that many homeopaths offer things like Skype consultations in their marketing.

How the ASAI interpret the Code can be seen through their adjudications. Firstly, there is one against the Irish Society of Homeopaths. A key findings is -
HPRA advised the ASAI that currently under this scheme (NRS) there is only one licensed product for the treatment of colds and flu like symptoms. All other homeopathic products currently licensed in Ireland are under the Simplified Registration Scheme, with no indications.
Effectively, Irish lay homeopaths are limited to claiming to be able to treat colds and flu like symptoms.

However, that seems to be the only adjudication that relates specifically to homeopathy.

Consumer Protection
The Competition and Consumer Protection Commission (CCPC) enforces consumer protection legislation. One of the fundamental differences between the UK and Ireland is that consumer protection in the UK is devolved to local authorities whilst in Ireland it is centralised. It would appear that the CCPC has sweeping powers.

The most important piece of legislation is the Consumer Protection Act 2007 but there are others. A lot of is very dull reading and involves the setting up of a statutory body. Section 3 is were the important information starts. The below covers the most important aspects re CEASE therapy etc marketing.

Chapter 4 
Prohibited Commercial Practices 
55.—(1) A trader shall not engage in any of the following commercial practices: 
(a) a representation that the trader has an approval, authorisation or endorsement that the trader does not have, or making such a representation when the trader is not in compliance with that approval, authorisation or endorsement;
(b) a representation that the trader is signatory to a code of practice, if the trader is not;
(d) a representation that a product has an approval, authorisation or endorsement that it does not have, or making such a representation when the trader is not in compliance with that approval, authorisation or endorsement;
(f) a representation that supply of a product is legal, if it is not, or creating such an impression;
(g) a representation that a product is able to cure an illness, dysfunction or malformation, if it cannot;
Whilst the rest of the Act does make for interesting reading, the above provides sufficient information for the purposes of this post and the following one.

Next post?
The next post will look at the claims of individual Irish lay homeopaths has regards to homeopathy and autism.

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