Tuesday, 29 November 2016

The Society of Homeopaths and the Professional Standards Authority

This is a long story. 

For many years the Society of Homeopaths (SoH) have sought ways to enhance their standing and that of homeopathy overall. Several initiatives came to nothing. 

The SoH achieved Accredited Voluntary Register status with the Professional Standards Authority (PSA) in September 2014.

Professional Standards Authority
The PSA was created under the auspices of the NHS Reform and Health Care Professions Act 2002, subsequently amended by the Health and Social Care Act (2012). The latter gave the PSA responsibility for accredited voluntary registers.

The PSA used to be the Council for Healthcare Regulatory Excellence (CHRE) prior to the 2012 Act. Its main function then, and still is, oversight of statutory regulators, who are -

It was a Government decision to foist voluntary regulators on the PSA. For some of the voluntary registers, such as those associated with psychotherapy, accreditation could be regarded as a halfway house on the road to full statutory regulation. For others, it seems highly unlikely that they would desire statutory regulation and even if they did, stand zero chance of doing so. It requires legislation.

Accredited Voluntary Register
A voluntary register (VR) is just that. A list of people that can be signed up to. In the case of the SoH, if you meet their entry critieria and cough up the money, you can be on their register. 
Access to registration with the Society of Homeopaths is automatic for those who have qualified from one of the professional homeopathy courses recognised by the Society at the point when they qualified.
There is another route by which homeopaths can apply - evaluation of non-recognised qualifications and experience.

Registration does not seem to offer very much beyond discounted insurance. In theory, a register that has a Code of Ethics and Practice provides consumers with a certain amount of protection.

That a VR is accredited by the PSA apparently means - 
Accredited registers help people get better care by ensuring that the health practitioners they register are competent and trustworthy. They set standards for people working in unregulated health and care occupations, encourage them to meet them and take action to protect the public when necessary. They ensure that the information they and their registrants provide is clear and helps you to make informed choices about the practitioner you want to see and about the treatments, therapies, care and products they offer.
It also means they can use a "quality mark".

Accreditation Process and Approval
The PSA provide a guide on the accreditation process. In short, what happens is that an aspiring VR goes through a self-assessment process to see if meets the PSA's standards. If it feels it does, possibly after discussion with the PSA, it can complete an application form and populate a risk matrix and send them to the PSA along with payment.

The PSA will request that interested third parties submit information.

The PSA will review the documentation, make site visits, interview various senior staff of the VR, sit in on board meetings and (hopefully) sit in on a disciplinary hearing.

Then a panel will make a decision. A negative decision does not prevent a VR from applying again.

The PSA do not consider plausibility or efficacy of therapies in the accreditation process. Those questions are legally beyond their remit. The PSA have said at various points that they also lack the skills/knowledge to make judgments about efficacy.

The PSA can also make suggestions for changes to how a VR operates. They can also impose conditions on membership - changes that have to be made by the (next) review or accreditation 

Unfortunately neither the original approval document or the third party submissions are available on the PSA website. The only document is the current Review. Copies of the original accreditation have been obtained (via a Freedom of Information Act (FOIA) request). It makes for partially interesting reading. It is a long document, much of which is very dull. only some of which will be quoted. But first, Andy Lewis did make a submission to the PSA which he documents here. Returning to the PSA document...
The Panel considered whether homeopathy, as practiced by the Society’s registrants, could be defined as a health occupation. The Panel noted Call for Information submissions arguing that homeopathy is without a basis in evidence and not a health care practice, therefore unable to meet this Standard. The Panel noted that it is not its role to determine the efficacy of a therapy but to decide whether the Accreditation Standards are met.
Whilst this may have been disappointing to some, it is consistent with the legal framework that the PSA operates in.
The Panel discussed the division between the six professional and three lay members on the Society’s Board of Directors, noting that the statutory health and care professions regulators require 50% of each. The Panel emphasized that accredited voluntary registration is not statutory regulation and that the required outcome was to demonstrate that through effective lay involvement the public would be protected.
This is unsurprising. There are historical questions about SoH governance and its Board of Directors not always acting as such. Additional lay members could help with that.
The Panel considered a Call for Information response alleging that members of the Society had been associated with the ‘Andrew Wakefield / MMR vaccine’ controversy and related public health risks, such as ‘Steiner schools as unvaccinated communities’ leading to increased occurrences of disease outbreaks. The Panel noted the damage to public confidence in the Society that such allegations could cause. The Panel noted relevant actions carried out by the Society such as introducing guidelines for registrants and placing a public position statement on its website stating that it does not endorse the use of homeopathic medicines as an alternative to vaccination for the prevention of serious infectious diseases.
Could cause? Certainly the "prescribing" of homeopathic remedies to prevent malaria (homeoprophylaxis in the term used and it is highly controversial even among homeopaths) damaged the reputation of the SoH. Even more in terms of how it dealt with the subsequent complaints. If some members of the SoH do still offer homeoprophylaxis that clearly does represent a risk. 
The Panel noted Call for Information responses suggesting a risk that Society registrants have insufficient medical training to diagnose conditions that should be referred for medical treatment. The Panel noted that the Society’s risk matrix addressed those concerns, as their training requires ‘each course to provide a substantial amount of education in Anatomy and Physiology, Pathology and Disease, and to ensure that this knowledge and understanding is reinforced and integrated in the Clinical Education of students’. The Panel also noted the Society’s Code of Ethics and Practice states that ‘registered and student clinical members must be aware of their professional competence and where appropriate, will refer to other practitioners ensuring that the practitioner to whom they refer is suitably qualified’.
"Substantial" is debatable. Given that there are tensions between homeopathic concepts of "dis-ease" and what disease actually is, the value of such education is questionable. As for members being aware of their competence, there is evidence to suggest that some SoH members are not.
The Panel also noted the adjudication decision made by the Advertising Standards Authority (ASA) in July 2013 which instructed the Society ‘not to discourage essential treatment for conditions for which medical supervision should be sought, including offering specific advice on or treatment for such conditions.’ The Panel noted that the AVR team had contacted the MHRA, ASA and the GPhC to ensure they had no ongoing or further concerns.
Which seems strange. No concerns about who? The SoH or its members? Presumably the former as it seems very likely that at least the ASA would have ongoing complaints about SoH members' advertising.
The Panel noted a reduction in the Society’s reserves which it had attributed to the current economic climate, an aging core membership and expenditures such as its website re-design. The Panel noted however that the Society’s reserves were still in excess of their minimum requirements and that it aimed to build these further over the next year. The Panel noted that the Society’s financial sustainability would be reviewed again at annual review, if accreditation was obtained.
Worries about an aging core membership imply that the SoH has a recruitment problem. This could be due to a drop in the numbers of those studying homeopathy or it could be that joining the SoH is less attractive than other trade associations or not joining a trade association at all.
The Panel considered a concern raised about a YouTube link posted by the Society’s former Chair on Twitter, entitled ‘Homeopathy for Health in Africa – HIV/AIDS – Finding the Genus Epidemicus’ and whether this could impact the public’s confidence in the Society’s ability to manage its register. The Panel noted that the AVR team as part of its due diligence had confirmed the former Chair had posted the link after stepping down from that position but was still a registrant of the Society. The team suggested that posting this link did not appear to be in breach of the Code of Ethics and Practice or the ASA’s adjudication decision.
On the face of it, astonishing but it relates to the posting of the link. It is likely that the person concerned is Jeremy Sherr. Homeopathy for Health in Africa is chilling to look at but Sherr proposed a hugely unethical medical trial. This has been documented elsewhere (and do read the comments). Sherr would no longer appear to be a member of the SoH.
The Panel referred to a Call for Information response that suggested that homeopaths may prescribe products not licensed by the MHRA. The Society advised that although the advertising of unlicensed homeopathic remedies is prohibited, the supply of unlicensed remedies via pharmacies is not prohibited. The Society referred to a letter from Earl Howe, Parliamentary Under Secretary of State for Quality, writing on behalf of both the Department of Health and the MHRA in July 2012 regarding the Medicines Act 1968. The letter states: 
Section 10(4)(a) broadly exempts the pharmacist from the requirements for a manufacturer’s license to be able to prepare the product, and for a product license, to be able to supply the product to the patient. 
Section 10(3) of the Act on the other hand provides an exemption to pharmacists from the requirement for a product or manufacturer’s license, for the supply of a medicinal product prepared the specification of the client of the pharmacist.
The Society advised that manufacturers of unlicensed homeopathic remedies in the United Kingdom are pharmacies who are under the remit of the GPhC. The Panel noted that the AVR team contacted the GPhC to clarify if it had any concerns with regard to this issue and the Society. The GPhC responded that any of its registrants involved in the preparation, sale or supply of homeopathic remedies/medicines must ensure that they meet its Standards and the requirements of other regulators, as well as any legal requirements. GPhC registrants must practise only in areas in which they are competent and refer to others if needed. The GPhC would investigate complaints about the sale of homeopathic products where the individual or practice was considered to be in breach of its standards and refer aspects regarding the licensing or illegal sale of these products to the MHRA in the first instance.
This is in many ways the most troublesome element of the document. It may help to see Section 10 (3) and (4) of the Medicines Act 1968.
(3)Those restrictions do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist in accordance with a specification furnished by the person to whom the product is or is to be sold or supplied, where—

(a)the product is prepared or dispensed for administration to that person or to a person under his care, or 
(b)the product, not being a vaccine, plasma or serum, is prepared or dispensed for administration to an animal or herd which is in the possession or under the control of that person.
(4)Without prejudice to the preceding subsections, the restrictions imposed by sections 7 and 8 of this Act do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of—

(a)preparing or dispensing a medicinal product for administration to a person where the pharmacist is requested by or on behalf of that person to do so in accordance with the pharmacist’s own judgment as to the treatment required, and that person is present in the pharmacy at the time of the request in pursuance of which that product is prepared or dispensed, or 
(b)preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) or subsection (3) of this section or in paragraph (a) of this subsection provided that such stock is prepared with a view to retail sale or to supply in circumstances corresponding to retail sale and the preparation is done with a view to such sale or supply either at that registered pharmacy or at any other registered pharmacy forming part of the same retail pharmacy business;
As can be seen, there are considerable differences between what is quoted from the Lord Howe letter and the actual legislation. The Lord Howe letter seems to omit that 10 (4) relates to activities that happen on the pharmacy premises involving a patient and the pharmacist. 10 (3) is a lot less clear in terms of what it means. It does not specify where the transaction can take place. The definition of a "person under his care" is a question that much of the legality of UK lay homeopathy revolves around. This will be examined in more depth in another post.

The GPhC's response is problematic but has no bearing on the SoH's accreditation.

It is also important to note that homeopathic remedies are registered not licensed. 
The Panel discussed Call for Information responses suggesting instances where registrants’ websites could potentially breach ASA guidelines or otherwise have potential to mislead the public. It noted examples provided that could be perceived as a breach of the Cancer Act 1939 or where homeopathy was being recommended as an alternative treatment to conventional therapies rather than a complementary one. The Society confirmed that its policy, when advised of such websites, was to contact the owner and advise them to change the disputed areas accordingly and that it would take action if they did not. 
The Panel noted that the Society had contacted the owners of the named sites which had since either removed or modified the pages in question accordingly. The Panel noted the Society’s current proposals for a process to monitor registrants’ websites and published guidelines for advertising. The Panel restated that the Society would be expected to act if a registrant appeared to be in breach of its Codes.
The SoH confirms that it will take action against non-compliant member websites.
The Panel noted the Board’s ratification of Adjudication Panel and Appeals Panel decisions. The AVR team had been informed that this was intended to be a procedural review of the handling of complaints. The team had advised the Society that ratification of complaints decisions by the Board of Directors may impact on the independence and impartiality of the Society’s complaints procedure and it is not good practice. The Panel noted that the Society was considering removing the requirement for ratification of such decisions and introducing an independent reviewer to provide oversight of Adjudication and Appeals Panel decisions. The Panel decided to make this an instruction.
The SoH is instructed to remove Board ratification of complaint decisions to ensure greater impartiality.

First Review of Society of Homeopaths Accreditation
Every year, the PSA go through a review of the VRs that are accredited with them. The VR has to complete an application form, update risk information, respond to any Call for Information and pay a fee. The review can, in theory, result in removal of accreditation. It can also impose conditions on retaining accreditation.

The first review was conducted in September 2015. Again, it is a long document that only has short sections of interest.
The Panel reviewed a call for information response stating that ‘homeopathy cannot be considered a health care occupation and therefore the accreditation and re-accreditation of the Society is ultra vires’ (beyond the Authority’s legal power or authority). The response questioned whether the Panel could accept ‘health claims’ made about homeopathy as a form of health care as laid down in the National Health Service Reform and Health Care Professions Act 2002. The Panel disagreed that its initial decision was ultra vires, noting that homeopathy is used by the public as a form of healthcare and is provided by the NHS. The Panel restated that questions of efficacy are outside the remit of the Accredited Registers programme.
Again, the PSA confirms that certain matters are outside of its remit.
When reviewing Standard 2 the Panel noted previous and future planned changes to the Society’s governance including the introduction of a Head of Professional Standards role and recruitment of two new independent (lay) members for its Professional Standards Committee. The Panel also noted that the Society has developed 'Guidelines for Safeguarding Children' and Fitness to Practise guidelines for registrants.
In theory, this should result in more impartial and less doctrinal decisions. The theme of conflicts of interest and lack of impartiality crop up more than once in all the PSA documents.
When reviewing Standard 8 the Panel noted amendments to the Society’s Code of Ethics and Practice including its requirements regarding Advertising and Media. The Codes state registrants must ensure they ‘do not allow misleading advertising and information about their practice’ and must comply with relevant laws relating to advertising. The Panel noted that the revision of the Codes stated ‘the Society may also take into account ... relevant clauses of The UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing’ (the CAP Code) when investigating breaches of the Code. The Panel considered that the Advertising Standards Authority’s guidelines and CAP Code reflect good practice in advertising and that it would expect Accredited Registers to follow these. The Panel decided to issue an instruction for the Society to replace ‘may also take into account’ with ‘will also take into account’ to be implemented within three months. In making its decision the Panel considered the impact of the decision on the Society and noted that the Committees of Advertising Practice (CAP) is reviewing its Advertising Guidance (previously Help Notes) on health claims in due course.
Replacing words may not seem terribly significant.
The Panel noted concerns raised within a Call for Information response about sections of the Society’s amended Professional Conduct Procedure. Section 2.1 of the procedure provides a list of who can raise a complaint against a registrant, which might be seen to limit or prevent concerns from being raised. The Panel noted that Section 3.1 states that the Society may accept complaints received outside of those requirements and noted this is not limited to any particular source of concerns, such as through news or social media. The Panel noted this section allows the Society the discretion to investigate concerns outside the criteria of Section 2.1. The Panel noted the Society’s confirmation that it will investigate any concern raised in order to see if it has any validity. The outcome of the investigation will determine if it becomes a formal complaint.
This document shows contains the offending section.
2.1 A complaint can only be brought by: 
a) a member of the public who has sought or received a service provided by a registered member of the Society; or  
b) a current registered member of the Society who may bring complaints for services sought or received directly from another registered member; or who has witnessed poor practice delivered by another registered member; or on behalf of another where their written permission has been obtained, and where that person is unable to bring the complaint on their own behalf (explanation is required in writing as to the nature of the inability); or 
c) a legal guardian or other appropriately authorised adult on behalf of a minor and/or an adult lacking legal capacity for services sought or received; or  
d) a third party who can demonstrate sufficient interest and who has been directly affected by the actions of the practitioner.
Which should also be read in conjunction with
2.2 All complaints will be treated seriously, however under these rules a complaint may be rejected at any time, if in the PCO or PIP’s opinion, the complaint is “frivolous, or vexatious”
Lastly
The Panel noted a reduction in Society registrants since its initial accreditation and the Society’s plans to promote registration and the occupation it registers accordingly. The Society raised its registration fee by £5 in 2015 and had not yet decided on any changes for 2016. The Panel noted changes implemented by the Society since its initial accreditation will assist it to provide benefits to service users and the public through the information provided on its register and website.
The number of registrants has been in decline for a number of years.

Second Review of Society of Homeopaths Accreditation
This was completed in September 2016. It can be found on the PSA website but it may well disappear when the 2017 review is published.

The team checked that the Society’s Code of Ethics and Practice (August 2015) had been amended and published on the Society’s website, as required by this Instruction, within the required timeframe. This section of the Code has also been amended to reflect other updated guidance such as the Blue Guide: advertising and promotion of medicines in the UK as noted under Standard 3 of the annual review form. The code states that: 
'40) Members should ensure that they do not allow misleading advertising and information about their practice. Advertising should be honest, decent, legal and truthful, and must comply with the relevant laws relating to advertising including The Trade Descriptions Act 1968; The Consumer Protection from Unfair Trading Regulations 2008 and The Blue Guide from the Medicines and Healthcare Products Regulatory Agency (MHRA). Examples of Codes the Society will also take account of are the relevant clauses of The UK Code of Non-Broadcast Advertising, Sales Promotion and Direct Marketing (CAP Code), and the current guidelines of the Society. See also paragraph 34.’ 
The Society advised the team that no other changes to the Code of Ethics and Practice had been made over the past year.

Mentioning the MHRA Blue Guide is important.
The Society had invited the public to debate the use of data from animal research in the field of homeopathy and provided links to articles on this matter. The Society will provide further guidance this year following a membership poll held in July 2016.
Vaguely interesting.
As part of its due diligence the team conducted its own spot check of Society registrants to check adherence to the Society’s standards for advertising. The team identified one example of a website that might be in breach of those standards and referred it to the Society. The Society confirmed the breach and advised that in the first instance, in line with its process, it would attempt to work with the registrant to improve the information provided. Should the registrant fail to cooperate the Society will initiate its Professional Conduct Procedures and may refer to Trading Standards.
May refer?
The Society advised the team in December 2015 that it had been contacted by the Committee of Advertising Practice (CAP). CAP advised it would contact homeopathic practitioners in 2016, providing a one-month deadline for practitioners to meet the standards of the Advertising Standards Authority (ASA) (as outlined in CAP’s ‘Guidance for Advertisers of Homeopathic Services’). After this period, CAP would conduct extensive spot-checks and refer breaches to Trading Standards where necessary. CAP urged the Society as the largest homeopathy trade body, and as an Accredited Register, to support the ASA’s position and work with CAP to enforce practitioners’ compliance with its guidelines. The Society responded that it could not support the one-month deadline but would work with CAP to ensure registrants were compliant with reasonable guidelines. 
The Society advised that it had held meetings with the ASA/CAP team to discuss an approach and develop further guidance for homeopaths, which could be used as a national standard. The Society’s board had approved the guidance and was awaiting further contact from the ASA/CAP team before launching the guidance, with further support for registrants such as FAQ’s in the members’ area.
It is not clear if the CAP spot-check process is under way. This will be discussed in a later post.

Voluntary Regulation <> No Regulation
One implication of the above is that the SoH has to act as a regulator. It has to ensure, to the best of their ability, the compliance of its members and if they do not, take remedial or even disciplinary action against them. If they do not, the PSA has the ultimate sanction of removing accreditation. 

The burden is much heavier that it might first appear.

In effect, the SoH has to take on the role of the ASA with regard to the advertising of its members. If you take a look at an ASA ruling on advertising by a homeopath such as this one you'll notice that it only raises a small number of issues. From experience, there can be many more issues with a website. The SoH will have to exhaustively examine and investigate a website for non-compliance with the CAP Code, possibly social media accounts that link to/from the website and email newsletters and so on. If non-compliance with the CAP Code remains an issue, the SoH may have to have to move to a model where advertising is subject to vetting pre-publication. 

One area of advertising that is particularly awkward is the promotion of unregistered homeopathic medicines. Only those few homeopathic medicines registered with the MHRA can be mentioned and only those registered under the National Scheme can be discussed in terms of what they can be used for and only then in terms of the indications that appear on the packaging, patient information leaflet, etc. Those registered under the Simplified Scheme can be mentioned but with no discussion of what they can be used for. More generally, the SoH will have to refer to the MHRA Blue Guide and the Human Medicines Regulations 2012 when dealing with complaints.

The SoH also have to take consider matters covered by the Consumer Protection from Unfair Trading Regulations 2008 but not explicitly covered by the CAP Code. The Regulations 2008 are a lot clearer about matters such as the omission of important information being misleading. 

In the past there have been complaints that members of the SoH have acted outside of their competence which were brushed aside, attempting to prevent/treat serious medical conditions. This is no longer possible. Determining the boundaries of an individual's competence is not a simple matter but appropriate training is often a consideration. 

It may also be the case that the SoH are no longer in a position to let criticism of individual members that is not in the form of a direct complaint pass them by. Rather react to submitted complaints, if they become aware of possible non-compliance through, for example, something like the Newsnight investigation into homeopaths offering homeoprophylaxis, they may have to proactively investigate without the prompt of a complaint.

What is not clear is that beyond the sanctions open to the SoH, what they would do the case of non-compliant members when questions of illegality are raised. They say they may refer non-compliant members to Trading Standards but what about other authorities? 

There are tensions between an organisation serving the interests of its members and regulating them. Sometimes, there is conflict. Membership can lose faith in a distant corporate body that seems unsympathetic to their interests and frequently acts against them or their peers. In the case of a VR, members can simply walk away. 

A Rock and a Hard Place
The PSA would be placed in a difficult position if the SoH do not achieve sufficient member compliance. So far, the PSA has not had to remove accreditation from a VR. If they did it could be seen as a failure of the whole business of accrediting fringe groups. If they don't, it could be seen as a failure of the PSA to uphold the rigourous standards they stand for. Both would undermine public confidence in the PSA.

It's not only the SoH that pose this problem for the PSA. The Complementary and Natural Healthcare Council (CNHC) do as well. Their accreditation did draw some criticism. The CNHC does have a peculiar history - which is outside of the scope of this blog.

However, the public at large are unlikely to be aware of the PSA and its role and powers. It tends not to interact directly with the public. What probably matters more are the PSA's relationships with other VRs, statutory regulators such as the General Medical Council, professional trade bodies in regulated profession (eg Royal College of Physicians) and Parliament who ultimately have oversight over the PSA. They can also be summoned by the Health Committee to answer questions (see an example - homeopathy is discussed and it is illuminating - the issue of homeoprophylaxis yet again). The video mentions that the fees from each VR are ringfenced and the intention is that the oversight of each VR will become self-funding.

Would a VR that struggles with compliance be more costly to oversee or are the costs of oversight fixed?


Friday, 25 November 2016

Qualified to judge?

One of the claims that is frequently made by some homeopaths is that the ASA has used expert witnesses who are not in a position to draw conclusions about homeopathy because they have no qualifications in homeopathy. It is often an accusation made of anyone who criticises homeopathy.

Not Occult
Occult can be defined as "knowledge of the hidden". It seems apt in this context as some have accused homeopathy of being "occult" in the common sense of the word.

The idea put forward that homeopathy can only be judged by those "qualified" in homeopathy is strange. There is a vast amount of "information" (some of which is wildly contradictory) on homeopathy in the public domain. Many out-of-copyright books can be found on the internet, including those by Hahnemann, etc. There are many other resources too that cast light on the various modern practices of homeopathy. Also, there is David Colquhoun's FOIA request which obtained course materials from a now defunct BSc Homeopathy course.

Whether one accepts the tenets of homeopathy, there is nothing mysterious about it. Gaining a "qualification" in homeopathy (certainly in the UK) does not confer some special status. Homeopathy is not a mystery religion nor is it an esoteric order with levels of initiation. There is no secret knowledge imparted on "qualification". At best, you get to put a few letters after your name of questionable status.

Homeopathy is in reality a form of vitalism

Plausibility
There are three elements in considering plausibility.

Firstly, the vitalistic homeopathic concept of "dis-ease" -
...they are solely spirit-like (dynamic) derangements of the spirit-like power (the vital principle) that animates the human body.
Hanhnemann posited that disease was caused by invisible, intangible forces called miasms (apologies for the gnomic language), which is not quite like miasmatic theory. Hahnemann died before germ theory had become accepted. Whether he would have revised his thinking in the light of the work of Pasteur and Koch is moot. But what is clear is that many of his followers did not revise their thinking. James Tyler Kent said -
The microbe is not the cause of disease. We should not be carried away by these idle allopathic dreams and vain imaginations but should correct the √Član vital.
and
The bacteria is an innocent feller, and if he carries disease he carries the Simple Substance which causes disease, just as an elephant would.
The degree to which modern homeopaths reject germ theory varies and there does seem to be tremendous confusion in some - miasms get mixed up with germ theory, genetic conditions and other causes in an opaque and muddied mishmash. There is also the problem of a public that largely accepts germ theory (and other causes) even if vitalism still has some hold on the popular imagination (qv Star Wars and its concept of the "Force").

Secondly the linked concepts "susceptibility" and "suppression".

There is nothing particularly controversial in stating various factors such as genetics, environment, lifestyle and current health status play a role in the likelihood of developing a certain condition. These factors can make you more susceptible to contracting disease. For example, if you have lowered immune system function, the more likely you are to develop pathogenic infections and the more likely to experience serious symptoms whilst others maybe be totally asymptomatic. However, the homeopathic concept of susceptibility is somewhat different. Do read that article carefully as clearly demonstrates how different the ideas are. Some other homeopaths would also stress the moral/spiritual aspects of susceptibility - the "vital force" is essentially spiritual. Morality and spirituality are strongly linked in some minds.

Again, homeopaths can become very confused between modern ideas of risk factors in health and the homeopathic notion of susceptibility.

Suppression is basically the idea that if you treat a symptom with conventional medicine, you do not address the cause. That cause left untreated will manifest itself in more and probably more serious symptoms. For example, if you apply a soothing cream to an itchy rash, you will develop a more serious "dis-ease" like psoriasis. This idea is at the heart of many homeopaths antipathy towards conventional medicine. Of course, when a homeopathic remedy is used to alleviate a symptom, it does not cause suppression.

Some conditions have no cure. Often the best that conventional medicine can do is help manage the condition in such a way as allow the best quality of life for the patient. This can involve lifestyle advice, etc. There can be conflict between the concept of homeopathy being able to cure almost anything if only the right remedy can be found and acknowledging medical reality.

Thirdly, the theory of homeopathic "cure".  At the heart of it, yes, correcting imbalances in the vital force caused by miasmatic influence but how? Especially in the light of how homeopathic remedies are prepared? It is assumed that most readers will know - if you do not, follow the link. A few theories (in no particular order) associated with homeopathic cure -
  • "Like cures like" or the law of similars - the concept that a substance that causes symptoms in a healthy individual can cure disease with the same symptoms.
  • Law of Simplex - only a single remedy to be given in a period of time (which is a matter of debate how long it should be).
  • Minimum dose - The quantity of a medicine which is though smallest in quantity produces the least possible excitation of the "vital force" and yet sufficient to effect the necessary change in it. Or something along those lines.
  • Potentisation - A "process by which the medicinal properties which are latent in natural substances while in their crude state, become awakened and developed into activity to an incredible degree." The "energetic essence" or "dematerialised spiritual force" is transferred from the original substance by a process of sequential dilution and mechanical agitation. This aspect of homeopathy that draws the most criticisms regarding plausibility. Homeopathic remedies are often created from substances that have been so diluted that the probability of them containing even a single molecule of the original substance is infinitesimal - for practical purposes zero. This linked to the idea that the more dilution occurs, the more powerful the remedy is, which draws even more criticism.
  • Doctrine of Proving - This needs to be considered in the context of the Law of Similiars. "Proving" is a not a clinical trial in the common sense of the phrase. There are no controls, the "symptoms" recorded not only relate to the physical but also the emotional and psychological. Indeed, many homeopaths place great store on dreams experienced.
  • Direction of Cure - This is linked to the idea that homeopathy often doesn't "cure" with use of a single remedy. Over time, different remedies are given, alleviating different symptoms. More recent symptoms are "cured" first, older symptoms later. "Cure" often works from vital organs to less vital organs, from the centre to the circumference, from above downwards. "Dis-ease" if often seen as being like an onion, "cure" peels away layers of symptoms and causation.
  • Aggravation - The justifications of aggravations are too long to go into here. In short, selecting the wrong remedy or wrong potency can induce "artificial disease". Most would call these side effects.
  • Healing Crisis - In homeopathic terms, this could be thought of the appearance of suppressed symptoms. It can be thought of terms of feeling worse as a result of toxins (actual or spiritual/moral) being released before they are expelled from the body. Certain medical treatments can do this but it is called a side effect.
  • Totality of Symptoms - Homeopathic remedies are often selected on the basis of comparing a patient's symptoms, one by one, with symptoms listed in a Repertory. Suggested remedies for each symptom are compared (of which there can be many) and in theory the remedy that is listed with the majority of symptoms is chosen. Computerised repertories exist which reduce the need to trawl through pages of a book. However, the symptoms used can be as baroque as the ones mentioned in provings and many of them would be thought by most to be irrelevant.
The Man on the Clapham omnibus is a legal fiction who is a reasonably educated and intelligent but nondescript person, against whom the defendant's conduct can be measured. It would be reasonable to ask the question as to whether such an individual when presented with a concise description of core homeopathic theories would find them plausible? Would they not see contradictions in them or the disdain for conventional medicine? If the line is taken that such a person lacks the "qualifications" to make such a judgment then either the explanation is insufficient clear or a piece of information is missing. The point is made again that there is nothing particularly mysterious about the tenets of homeopathy.

It is possible to ignore the question of plausibility. Some homeopaths say they do not know how homeopathy works, but they insist that it does. A pragmatic viewpoint even if does invalidate much of what homeopaths are taught - it involves ditching all the theory. Pragmatically, if homeopathic remedies are efficacious, who cares how they work?

Efficacy
Efficacy is a difficult concept for some. It has a specific meaning in this context -
It is used in pharmacology and medicine to refer to both the maximum response achievable from a pharmaceutical drug in research settings, and to the capacity for sufficient therapeutic effect or beneficial change in clinical settings.
Effectiveness, whilst synonymous with efficacy in the common sense of the word, also has a specific meaning -
Effectiveness refers to "how the drug works in a real-world situation," and is "often lower than efficacy because of interactions with other medications or health conditions of the patient, sufficient dose or duration of use not prescribed by the physician or followed by the patient, or use for an off-label condition that had not been tested."
Efficacy is determined by clinical trials. They can take various forms but the "gold standard" is considered the Randomised Controlled Trial (RTC). There are forms of clinical trials as well but they are considered less powerful (although they can provide useful results). A fuller discussion of clinical trials is beyond the scope of this blog. Nevertheless, the quality of a clinical trial is down to two main factors - the design of the trial to eliminate potential bias (although this does not help with reporting bias) and the size of the trial. It also helps if the outcomes are physically measurable as opposed to subjective scoring of subject experience - quantitative rather that qualitative.

The Man on the Clapham omnibus certainly would lack the specialist skills and knowledge to evaluate a trial design, detect any problems with bias, and interpret the results as would a member of the ASA or the vast majority of homeopaths (if any) for that matter. So obviously, it would make sense for the ASA to use an external expert. If the objection is again raised of lack of homeopathic "qualifications" and accusations of bias are made, the difficult is that some with homeopathic "qualifications" would be unlikely to have the right skills and knowledge and even if they did, they would be open to questions of confirmation bias especially in assessing trials that had confirmation bias themselves.

Effectiveness? There are ways to study this but without the benchmark of efficacy, the measure would have little meaning. Off-label use is another matter though and beyond the scope of this blog.

Clinical trials - a bad fit?
It is often said that clinical trials, especially RCTs are a bad fit for homeopathy. Homeopathy treats the person not the disease, the totality of symptons, etc or whatever any of that means. There is some truth in that designing a trial/study to measure the efficacy of homeopathy is difficult - which will be discussed later.

One problem with any clinical trial of homeopathy is cost. Organisations that provide research grants have criteria in assessing any potential trial. Plausibility certainly is one.  Whilst some homeopathic medicine manufacturers are large and extremely profitable, they do not seem to disburse funds for large scale trials. Smaller trials are possible but would lack statistical power.

Another problem with any clinical trial are the ethics of giving patients with a more serious pre-existing condition a placebo. This would limit clinical trials to minor self-limiting conditions.

It may also be the case that some homeopaths believe that a single positive study that has sufficient size, statistical power and significance would validate the whole of homeopathy, especially if it was replicated. However unlikely this might appear, even if it happened it would not. It would apply to a single remedy. Such a trial might be better as a three-armed trial - placebo, remedy A and remedy B.

One of the problems with trials of homeopathy is that is very likely that the consultation would enhance any potential effect from the remedies (placebo or not). This study comes to the conclusion that homeopathy remedies have no effect in patients with rheumatoid arthritis but the consultation does, albeit on secondary outcomes. It has been long suggested that this might well be the case (see here for another take on that). A homeopathic consultation is much longer than a GP appointment, for example, and has a much broader scope. The validity of the trial is not a question to be addressed here (for one thing it is small) but certainly it does provide a potential model for future trials involving other conditions. It would also be useful to compare, perhaps, homeopathic consultations with a sham homeopathic consultation or talking therapies.

Certainly not a conclusion that would please some homeopaths. 

There are homeopathic medicines that are widely available over the counter (OTC) and can be sold by any retail outlet - they are on the General Sales List (GSL). Some even have indications for use. The Human Medicines Regulations 2012 allow this without any need for evidence of efficacy. This is unlikely to change - there is no requirement for them to undergo clinical trails. But a homeopathic medicine that made claims beyond "traditionally used in homeopathy for minor self-limiting condition X" would need to. 

Homeopathy has a concept of the genus epidemicus. Unfortunately, it is difficult to find a succinct definition but...
A remedy which is found to be curative in the majority of cases of the same disease (e.g. epidemics). Hahnemann taught that the genus epidemicus remedies should be chosen by the uncommon characteristic symptoms of all the patients not the common symptoms of the epidemic disease.
Which would certainly be amenable to RCTs although the ethics of performing one during an epidemic would highly question. The concept of the genus epidemicus is often associated with homeoprophylaxis.
Homeoprophylaxis (HP) is the use of potentized substances in a systematic manner to prevent the development of the characteristic symptoms of disease.
In other words, homeopathic immunisation. Again, amenable to RCTs although there would be ethical problems. Homeoprophylaxis is very controversial even amongst homeopaths. Trials have been done, the ethics of which raise serious questions.

Confirmation bias and cognitive dissonance
It is clear that in presenting evidence of the efficacy of homeopathy, many homeopaths are very selective in which trials and studies they pick and ignore all the rest. The quality of the trials and studies they pick are immaterial to them, that is even if they have the ability to determine the quality of them. Of the eight homeopaths mentioned in the Quackometer blog, none appear to have any kind of biomedical qualification.

It also seems to be the case that anyone who presents evidence contrary to their point of view is presumed to be biased. Either you are with them, or against them. Which is a false dichotomy. Saying that there is currently, on balance, no compelling evidence that homeopathic remedies have any effect greater than placebo is in fact a neutral position. It leaves open the door to future evidence. "Homeopathy does not work" is not a neutral position. Saying that the purported mechanism of action is implausible as it would violate what is currently known of physics, chemistry and biology is also a neutral position. 

The letter on the Quackometer blog could be read to imply conspiracy on the part of some. It is not unknown for homeopaths to invoke conspiracy theories, especially regarding vaccination and "Big Pharma" (although that is not to discount the malfeasance on the part of pharmaceutical companies). The psychology of conspiracy theories is interesting in itself.

The letter also contains ad hominem criticisms that are irrelevant to the question of whether speech is being restricted. Ad hominem tu quoque.

Homeopathy on trial?
Whilst there have been UK court cases that have involved homeopaths either as defendants or witnesses, research has not revealed a case where a homeopath has been put on trial for the practice of homeopathy. Research has not revealed a case where a non-medically qualified (lay) homeopath has been called as an expert witness. Nor has it revealed a case where a court has been asked to decide on the validity of homeopathy.

There is unlikely ever to be one. The practice of homeopathy in itself is not illegal.

Solutions
Obviously anyone who wishes to make a judgment on homeopathy needs a "qualification" in homeopathy. Fortunately, there are several ways to do this. Boiron offer online training. It's also possible to purchase qualifications up to a Ph.D from a diploma mill. Or you could knock one up on your computer using grandiloquent language, print it out and frame it. This would remove any objections by homeopaths, surely? There are homeopaths practicing who do have diploma mill "qualifications".

Joking aside, homeopaths need to understand the different between pure and commercial speech, promotion and editorial, fact and opinion. That there is a need to self-censor when promoting homeopathic services and medicines to the public. It is the price of doing business. Separation of activities is key. Write books, articles, forum posts, etc and they are free speech (subject to the legal limitations - and be careful of unbalanced coverage of unlicensed homeopathic medicines in more public fora though). It is linkage that is the problem. Also beware that email newsletters can be problematic.

Returning to the question of "qualifications" - publicly stating that someone is in no position to make judgments on the plausibility and efficacy of homeopathic services and medicines can have the effect of reducing your own credibility with potential consumers. It also implies that consumers can not rationally choose a homeopathic service or medicine without in depth knowledge of homeopathy. It is better not to make such statements.

Wednesday, 23 November 2016

Antipathy towards the Advertising Standards Authority #1

Whilst it is understandable that homeopaths and other alternative therapists may be unhappy that ASA rulings may go against them and that the CAP Codes and advertising guidance does place limitations on the claims that can be made, the level of antipathy shown by some is less understandable. To a reasonable observer, it can appear irrational to say the least.

What Homeopaths say
The kind of statements that certain homeopaths are making about the ASA include (in no particular order) -
  • The ASA disregards positive evidence for the efficacy of homeopathy
  • The ASA is biased against homeopathy
  • The ASA has no legal authority
  • The ASA has no moral authority
  • The ASA misrepresents itself as a branch of government
  • The ASA is guilty of bullying homeopaths. Harassment is also mentioned
  • The ASA is guilty of criminal offences
  • The CAP Codes do not represent the legislation that covers advertising (and thus have no force)
  • The ASA is unduly influenced by groups such as Sense about Science and the Nightingale Collaboration who are in turn financed by the pharmaceutical industry
  • Subject matter experts used by the ASA have no expertise in homeopathy and thus unqualified to give an opinion
  • The ASA is part of a conspiracy
  • The ASA's actions are a breach of the right to free speech and a form of censorship
  • The ASA is anti-competitive
Probably some more as well. Skepticat discusses some of the above here. The ASA is more than capable of defending itself as well. The focus of this post is different though...

Free Speech and Advertising
It is sometimes claimed that the ASA are somehow restricting freedom of speech. However, if you are advertising or marketing something, free speech no longer applies (in full). Although the UK is not the US, because they have a written constitution and the First Amendment protects free speech, there have been some Supreme Court judgments that do aid in understanding. In the UK, until the Human Rights Act 1998 (HRA), there was no explicit right to free speech. Instead, there was a situation where there were a number of laws that restricted free speech in certain circumstances but beyond that, nothing. UK law can work on the principle that was is not expressly forbidden is permitted whereas other jurisdictions work under the principle of what is not expressly permitted is forbidden. Whilst it can be argued that the HRA materially changes nothing regarding the right to free speech, it does make explaining things easier!

The HRA places the European Convention on Human Rights (ECHR) into UK law. The ECHR, despite the perceptions of many comes from the Council of Europe (CoE) rather than the EU. No member state of the EU is not a member of the CoE but there are members of the CoE (Russia for example) that are not members of the EU. The European Court of Human Rights (ECtHR) represents the ultimate court of appeal.

Some homeopaths have quoted -
Article 10 – Freedom of expression
1. Everyone has the right to freedom of expression. This right shall include freedom to hold opinions and to receive and impart information and ideas without interference by public authority and regardless of frontiers.
But that's not the whole of it...
Article 10 – Freedom of expression
1. Everyone has the right to freedom of expression. This right shall include freedom to hold opinions and to receive and impart information and ideas without interference by public authority and regardless of frontiers. This article shall not prevent States from requiring the licensing of broadcasting, television or cinema enterprises.

2. The exercise of these freedoms, since it carries with it duties and responsibilities, may be subject to such formalities, conditions, restrictions or penalties as are prescribed by law and are necessary in a democratic society, in the interests of national security, territorial integrity or public safety, for the prevention of disorder or crime, for the protection of health or morals, for the protection of the reputation or rights of others, for preventing the disclosure of information received in confidence, or for maintaining the authority and impartiality of the judiciary.
Which is rather different. 

The EU has corresponding legislation - the Charter of Fundamental Rights of the European Union. The European Court of Justice (ECJ) represents the ultimate court of appeal. Some homepaths have quoted -
Title II - Freedoms  
Article 11 Freedom of expression and information 
1. Everyone has the right to freedom of expression. This right shall include freedom to hold opinions and to receive and impart information and ideas without interference by public authority and regardless of frontiers. 
2. The freedom and pluralism of the media shall be respected.
And then fail to read further down.
Title VII - General provisions governing the interpretation and application of the Charter  
Article 52 Scope and interpretation of rights and principles 
1. Any limitation on the exercise of the rights and freedoms recognised by this Charter must be provided for by law and respect the essence of those rights and freedoms. Subject to the principle of proportionality, limitations may be made only if they are necessary and genuinely meet objectives of general interest recognised by the Union or the need to protect the rights and freedoms of others.
Which does effectively mirror 2. above although it does not explicitly spell out the justifications for limitation.

Whilst the ECtHR and ECJ are separate bodies, it is certainly true that in some cases the ECJ takes note of ECtHR rulings in coming to its own determinations. 

The US Supreme Court in Valentine v. Chrestensen established the notion of commercial speech which is a much more useful concept than advertising or marketing - some of those with ASA rulings against them have stated that they did not regard what they have written as advertising. That they holding an opinion and imparting information and ideas. There is no explicit definition of commercial speech in either the ECHR or EU law but...

A definition of commercial speech (expression) can be found in Opinion of Mr Fennelly — Cases C-376/98 And C-74/99.
The case-law of the European Court of Human Rights indicates that all forms of expression merit protection by virtue of Article 10(1) of the Convention. This includes what is commonly known as commercial expression, that is, the provision of information, expression of ideas or communication of images as part of the promotion of a commercial activity and the concomitant right to receive such communications.
"as part of the promotion of a commercial activity" is key.

Free speech is not absolute
As mentioned above, there may be limitations to free speech in law - varying from jurisdiction to jurisdiction. Whilst there is a moral duty and responsibility not to abuse the right to free speech, many do abuse. The laws that set these limitations (and court decisions that arise) can seem arbitrary or wrong - indeed some of them have been challenged in the ECJ and ECtHR and governments have been ruled against.

To quote from Wikipedia, the UK limitations on free speech are -
...threatening, abusive or insulting words or behaviour intending or likely to cause harassment, alarm or distress or cause a breach of the peace (which has been used to prohibit racist speech targeted at individuals), sending another any article which is indecent or grossly offensive with an intent to cause distress or anxiety (which has been used to prohibit speech of a racist or anti-religious nature), incitement, incitement to racial hatred, incitement to religious hatred, incitement to terrorism including encouragement of terrorism and dissemination of terrorist publications, glorifying terrorism, collection or possession of a document or record containing information likely to be of use to a terrorist, treason including advocating for the abolition of the monarchy (which cannot be successfully prosecuted) or compassing or imagining the death of the monarch, sedition, obscenity, indecency including corruption of public morals and outraging public decency, defamation, prior restraint, restrictions on court reporting including names of victims and evidence and prejudicing or interfering with court proceedings, prohibition of post-trial interviews with jurors, time, manner, and place restrictions, harassment, privileged communications, trade secrets, classified material, copyright, patents, military conduct, and limitations on commercial speech such as advertising.
Commercial speech is subject to more limitations that "ordinary" or "pure" speech. Consumer protection is the most obvious.

The Consumer Protection from Unfair Trading Regulations 2008
This is the primary legislation that controls commercial speech amongst other things. Other legislation exists (and there is a lot of it) but is often industry/product specific.

Even though it is much clearer than the legislation it replaces, it is not easy to read. In short, this is where the legal, honest and truthful requirements come from. Rather cut and paste chunks of the legislation, SCHEDULE 1 - Commercial practices which are in all circumstances considered unfair has several clauses that are of particular relevance.
9. Stating or otherwise creating the impression that a product can legally be sold when it cannot. 
17. Falsely claiming that a product is able to cure illnesses, dysfunction or malformations.
It is worth pointing out that the Regulations do implement various EU Directives, so parts of them can not be changed without changes first to the EU Directives or securing a UK opt-out.

The Human Medicines Regulations 2012
This is the legislation that kicked up a stink among homeopaths although for different reasons that the restrictions it places on what they can say. It's a consolidation (bar one section - which is extremely problematic) of prior legislation. Again, much clearer than what it replaces but still difficult to read.

What is considered advertising by the Regulations?


PART 1 General

Advertisements relating to medicinal products

7.—(1) In these regulations “advertisement”, in relation to a medicinal product, includes anything designed to promote the prescription, supply, sale or use of that product.
(2) This includes, in particular, the following activities—
(a)door-to-door canvassing;
(b)visits by medical sales representatives to persons qualified to prescribe or supply medicinal products;
(c)the supply of samples;
(d)the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefitor bonus, whether in money or in kind, except where the intrinsic value of such inducements is minimal;
(e)the sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products; and

(f)the sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products, including the payment of their travelling and accommodation expenses in that connection.



There are exemptions but the key thing is the anything designed to promote the prescription, supply, sale or use of that product. This is both broad in scope yet talks about a "product".


PART 4Requirement for authorisation

Requirement for authorisation

46.—(1) A person may not sell or supply, or offer to sell or supply, an unauthorised medicinal product.
(2) A person may not sell or supply, or offer to sell or supply, a medicinal product otherwise than in accordance with the terms of—
(a)a marketing authorisation;
(b)a certificate of registration;
(c)a traditional herbal registration; or
(d)an Article 126a authorisation.
(3) A person may not possess an unauthorised medicinal product if the person knows or has reasonable cause to believe that the product is intended to be sold or supplied to another person within the European Economic Area.
(4) A person may not in the circumstances mentioned in paragraph (5)—
(a)manufacture or assemble a medicinal product; or
(b)procure the sale, supply, manufacture or assembly of a medicinal product.
(5) Those circumstances are that the person knows or has reasonable cause to believe that the medicinal product has been or is intended to be sold or supplied contrary to paragraph (1).
(6) For the purposes of this regulation a medicinal product is unauthorised if none of the following is in force for the product—
(a)a marketing authorisation;
(b)a certificate of registration;
(c)a traditional herbal registration; or
(d)an Article 126a authorisation.


It is the offer to sell or supply that is key here in terms of what can be said. The restrictions on sale or supply are well known but will be revisited in a future post. Many homeopathic medicines are not registered.


PART 14Advertising

CHAPTER 2Requirements relating to advertising

General

Products without a marketing authorisation etc
279.  A person may not publish an advertisement for a medicinal product unless one of the following is in force for the product—
(a)a marketing authorisation;
(b)a certificate of registration;
(c)a traditional herbal registration; or
(d)an Article 126a authorisation.
General principles
280.—(1) A person may not publish an advertisement for a medicinal product with a marketing authorisation, traditional herbal registration or Article 126a authorisation unless the advertisement complies with the particulars listed in the summary of the product characteristics.
(2) A person may not publish an advertisement for a medicinal product unless the advertisement encourages the rational use of the product by presenting it objectively and without exaggerating its properties.

(3) A person may not publish an advertisement for a medicinal product that is misleading. 

280.(2) is problematic. It depends on an understanding of the terms "rational", "objective" and "exaggeration". Misleading speaks for itself.

Advertising to the public

Material relating to diagnosis
286.—(1) A person may not publish an advertisement relating to a medicinal product that states, or implies, that a medical consultation or surgical operation is unnecessary.
(2) A person may not, in particular, publish an advertisement relating to a medicinal product that offers to provide a diagnosis or suggest a treatment by post or by means of an electronic communications network within the meaning of the Communications Act 2003.
(3) A person may not publish an advertisement relating to a medicinal product that might, by a description or detailed representation of a case history, lead to erroneous self-diagnosis. 

286.(3) is problematic for some.
Material about effects of medicinal product
287.—(1) A person may not publish an advertisement relating to a medicinal product that suggests that the effects of taking the medicinal product—
(a)are guaranteed;
(b)are better than or equivalent to those of another identifiable treatment or medicinal product; or
(c)are not accompanied by any adverse reaction.
(2) A person may not publish an advertisement relating to a medicinal product that uses in terms that are misleading or likely to cause alarm pictorial representations of—
(a)changes in the human body caused by disease or injury; or
(b)the action of the medicinal product on the human body.
(3) A person may not publish an advertisement relating to a medicinal product that refers in terms that are misleading or likely to cause alarm to claims of recovery.
(4) A person may not publish an advertisement relating to a medicinal product that suggests that—
(a)the health of a person who is not suffering from any disease or injury could be enhanced by taking the medicinal product; or
(b)the health of a person could be affected by not taking the medicinal product.

(5) Paragraph (4)(b) is subject to regulation 292 (exception for approved vaccination campaigns). 

(4).(a) has implications for "constitutional remedies".


Homoeopathic medicinal products

Advertisements for registered homoeopathic medicinal products
301.—(1) A person may not publish an advertisement relating to a homoeopathic medicinal product to which a certificate of registration relates unless the advertisement meets the following conditions.
(2) Condition A is that the advertisement does not mention any specific therapeutic indications.
(3) Condition B is that the advertisement does not contain any details other than those mentioned in Schedule 28 (labelling requirements for registrable homoeopathic medicinal products).
(4) Nothing in regulation 291(2) (form and content of advertisement), 294 (general requirements) or 295 (abbreviated advertisements) requires an advertisement relating to a homoeopathic medicinal product to which a certificate of registration relates to contain any detail not specified in Schedule 28.

Yes, there are some other chapters and paragraphs that have some bearing on the advertising of homeopathic medicines but the above are the most relevant. But all this dry legislation relates to "products". How does that relate to homeopathic "services"?

Again, it is worth pointing out that the Regulations do implement various EU Directives, so parts of them can not be changed without changes first to the EU Directives or securing a UK opt-out.

Interpretation - The Blue Guide
The Medicines and Healthcare product Regulatory Agency (MHRA) helpfully provide a guide for advertisers (and others) - the Blue Guide. It is quite easy to understand and spells out the implications of legislation on advertising in very clear terms. It even has a section on homeopathy and the very clear statement -


5. Advertising homeopathy services Homeopathic practitioners may promote the service they provide for the public, e.g. the availability of a homeopathic consultation service. Details of products in any advertising must be limited to those licensed by the MHRA and must comply with the requirements set out in section 4 above.  
These restrictions apply equally to advertising on the internet. Product information, including sales material and any online purchase facility, may only be provided for licensed products.  
Any service that offers advice about treatment options based on answers to questions online should ensure that it does not suggest that a medical consultation is unnecessary. Only licensed products for minor, self limiting conditions may be offered without an individual consultation with a homeopathic practitioner.  
For more information, the Borderline Unit has provided specific guidance on how a company can give customers information on websites without making medicinal claims.
Which raises the thorny question of the definitions of "medical consultation" and "homeopathic practitioner". The latter will be discussed in a later post.

Interpretation - CAP Codes and specific ASA guidance
The Committee for Advertising Practice (CAP) produce the CAP Code. Quoting from the Preface -
The Committee of Advertising Practice (CAP) is the self-regulatory body that creates, revises and enforces the Code. CAP's members include organisations that represent the advertising, sales promotion, direct marketing and media businesses. Through their membership of CAP member organisations, or through contractual agreements with media publishers and carriers, those businesses agree to comply with the Code so that marketing communications are legal, decent, honest and truthful and consumer confidence is maintained.
It also says -
The Code supplements the law, fills gaps where the law does not reach and often provides an easier way of resolving disputes than by civil litigation or criminal prosecution. In many cases, self-regulation ensures that legislation is not necessary. Although advertisers, promoters and direct marketers (marketers), agencies and media may still wish to consult lawyers, compliance with the Code should go a long way to ensuring compliance with the law in areas covered by both the Code and the law.
It is certainly the case that most of the Code mirrors legislation and also the MHRA Blue Guide. Perhaps not in exact wording but certainly in meaning. Note the CAP Code fills gaps in legislation as well, removing the need for specific legislation. Where these gaps are is not always clear.

There is no point in reproducing huge chunks of the CAP Code given that more detailed guidance was given back in 2011(!) - and that in September 2016 a letter and a FAQ was sent to homeopaths (and others) prompting them to look at the CAP Code again (which now specifically mentions homeopathy).

To quote from the detailed guidance -
The need for evidence One of the key rules in the CAP Code is that advertisers need to hold evidence for ‘objective’ claims made in marketing communications. These are claims that consumers are likely to regard as objective i.e. they have a factual basis. The Code states the following: 
  • 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
The words ‘before... publication’ are crucial. As the marketer, you have a pre-publication responsibility for ensuring that your claims are borne out in fact and, where necessary, supported by robust evidence. Rule 3.7 is further clarified in the section specific to medicines and health-related products:
  • 12.1 Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. If relevant, the rules in this section apply to claims for products for animals. Substantiation will be assessed on the basis of the available scientific knowledge.
And later -

Claims to avoid In the simplest terms, you should avoid using efficacy claims, whether implied or direct, that aren’t supported by robust evidence. If you are stating or implying that you, your service or a product can be effective in doing something, you need to ensure that you have the evidence to prove the claim. 
If you are making claims for a homeopathic product, or for a treatment based on a specific product, or combination of products, you may only make such claims as are permitted by the product licence(s). You will need to consult the MHRA for advice on this point. 
To date, the ASA has have not seen persuasive evidence to support claims that homeopathy can treat, cure or relieve specific conditions or symptoms. We understand this position is in line with other authoritative reviews of evidence. 
We therefore advise homeopathy marketers to avoid making specific claims of efficacy for treatments where robust evidence is not held to substantiate them. 
Even if a specific product is not cited, marketers of homeopathy services should not state or imply that conditions or symptoms can be relieved or cured by homeopathy. This means marketing of homeopathy services should not use words such as ‘cure’ or ‘treat’, nor list medical conditions because the ASA has a long-standing position that, by doing so, readers are likely to infer that the conditions or symptoms listed can be alleviated. We advise that these claims are not used either directly or indirectly, including through the use of imagery.
And further on still - 
Telling consumers about published research on homeopathy The online environment has greater scope for providing information in a discursive or detailed way. Providing links to information such as published research is likely to fall outside the remit of the ASA if they are presented in a section of the website that is not directly connected with the sale or supply of your products or service. For example, under a separate tab labelled ‘research’ or ‘further reading’.
The guidance is very clear. Much clearer than the SoH guidance referenced below.

Interpretation - Society of Homepaths Code of Ethics and Practice and specific Guidance
The Society of Homeopaths Code of Ethics and Practice have undergone changes over the years (some of which stem from compliance with the Professional Standards Authority requirements - see here). The most recent version is dated August 2015 but it seems likely that it will require further updating. A lot of the content is irrelevant to advertising and promotion. Firstly -
Section 4 - Legal Obligations  
Criminal and civil law  
34) Registered and student clinical members are required to comply with the criminal and relevant civil law of the country, state or territory where they are practising.  
35) Registered and student clinical members must observe and are responsible for keeping up to date with all legislation and regulations relating directly or indirectly to the practice of homeopathy. 
36) 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 obviously cover the Consumer Protection from Unfair Trading Regulations 2008 and the Human Medicines Regulations 2012. The latter says something interesting though.

Misleading actions

5.—(1) A commercial practice is a misleading action if it satisfies the conditions in either paragraph (2) or paragraph (3).
(2) A commercial practice satisfies the conditions of this paragraph—
(a)if it contains false information and is therefore untruthful in relation to any of the matters in paragraph (4) or if it or its overall presentation in any way deceives or is likely to deceive the average consumer in relation to any of the matters in that paragraph, even if the information is factually correct; and
(b)it causes or is likely to cause the average consumer to take a transactional decision he would not have taken otherwise.
(3) A commercial practice satisfies the conditions of this paragraph if—
(a)it concerns any marketing of a product (including comparative advertising) which creates confusion with any products, trade marks, trade names or other distinguishing marks of a competitor; or
(b)it concerns any failure by a trader to comply with a commitment contained in a code of conduct which the trader has undertaken to comply with, if—
(i)the trader indicates in a commercial practice that he is bound by that code of conduct, and

(ii)the commitment is firm and capable of being verified and is not aspirational,


Which basically means that if a member of the SoH states that they abide by the SoH Code and does not, they are in breach of consumer protection regulations although technically, they may breach other regulations in order to breach the SoH Code.

Returning to the SoH Code -


Advertising and Media  
40) Members should ensure that they do not allow misleading advertising and information about their practice. Advertising should be honest, decent, legal and truthful, and must comply with the relevant laws relating to advertising including The Trade Descriptions Act 1968; The Consumer Protection from Unfair Trading Regulations 2008 and The Blue Guide from the Medicines and Healthcare products Regulatory Agency (MHRA). Examples of Codes the Society will also take account of are the relevant clauses of The UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing (CAP Code), and the current guidelines of the Society. See also paragraph 34.  
41) Professional advertising must be factual and not seek to mislead or deceive, or make unrealistic or extravagant claims. Advertising may indicate special interests but must not make claims of superiority or disparage professional colleagues or other professionals. No promise of cure, either implicit or explicit, should be made of any named disease. All research should be presented clearly honestly and without distortion; all speculative theories will be stated as such and clearly distinguished.  
42) Under the Cancer Act 1939, it is a criminal offence to take any part in the publication of an advertisement (which is likely to include electronic publications, such as websites, emails and social media) containing any offer to treat any person for cancer, or to prescribe any remedy for it, or to give any advice in connection with the treatment of cancer.  
43) Advertising content and the way it is distributed must not put prospective patients under pressure to consult or seek treatment from a registered or student clinical member.  
44) No registered or student clinical member may use their Society registration status in the advertisement or promotion of any product or remedy.
The SoH have also released more specific guidance on advertising. The first is dated December 2013 - which predates the current SoH Code. A key quote from the document...
Please note that this guidance applies to the ways in which we advertise and promote homeopathy: it does not necessarily cover the provision of information or education to patients and the public, unless this is linked with marketing and promotion.
The concept of linkage is important. The document does go on to discuss other matters - mainly revolving around there being insufficient scientific evidence to substantiate any claims to treat, cure or alleviate illness, etc. It offers some suggestions as to permissible content.

The second piece of guidance is dated July 2016. If anything, it is less thorough and less clear than the first guidance document.

Promotion
The implication of all of the above is that a website that exists to promote the homeopathic practice of an individual will be considered promotion in its entirely, perhaps with the exception of links to research (although discussing the research maybe considered promotion) and what is clearly opinion unrelated to homeopathy or health issues in general. Commenting on wider social issues, for example, Brexit would not be considered part of the "promotion".

What can be said on such a website is subject to legal limitation without a doubt.

Social media also can be considered promotion especially if it links (either via profile or individual posts) to a website that promotes the homeopathic practice of an individual. 

Information
To quote from an email sent out by various homeopaths (see the Quackometer blog for further information) -
ASA and CAP Ltd. are attempting to prevent homeopaths from communicating lawful information of their lawful trade to members of the public who have a legal right to know.
Lawful information? Of course, information about products and services is permitted (and omission can be misleading) but the information presented has to be substantiated as websites that contain the offer of homeopathic services would be considered promotion.

It is clear from the examination of the websites of certain members of the Society of Homeopaths that not only do they make unsubstantiated claims for the efficacy of homeopathy, they also make demonstratably false statements about other medical and healthcare issues, some of which are denigratory. The later is particular true of those vehemently opposed to conventional medicine.

In another context (eg a publication with an intended audience of homeopaths or perhaps a private forum), those comments would be permissible (assuming they were not libelous or breaching other restrictions on "pure" speech as opposed to commercial speech). But placing them on a website designed to promote a homeopathic service necessarily places more restrictions on speech.

Does the ASA restrict free speech?
Strictly speaking, no, not in the case of homeopathy and especially members of the SoH.

It neither makes the laws nor enforces them. It is a voluntary regulator. Whilst it has some sanctions available to it, ultimately a non-compliant advertiser would be referred to a statutory regulator who has the powers to seek injunctions on publication and even to prosecute under criminal law.

If one believes that the ASA restricts free speech then it could argued that the Society of Homeopaths restricts the free speech of its members to an even greater extent in that it has the sanctions of disciplinary action up to and including expulsion. It could also be argued that the Professional Standard Authority restricts free speech in that it is a condition of accreditation of a voluntary register that the members abide by the CAP Code. The PSA has the sanction of removing accreditation if it feels that the voluntary register has not met its conditions and standards.

Next?
The next post will consider the question of who is "qualified" to make judgments on homeopathy.