Saturday 28 September 2019

Prevalence of anti-vaccination sentiment

"Many parents who normally prefer natural immunity for their children with a healthy diet and constitutional treatment, have become disconcerted by the recent media hyped health scare. The issue of vaccinations is difficult for natural health practitioners to talk about as it has become a religious taboo – i.e. you are plainly irresponsible if you don’t do what the ‘officially sanctioned’ scientists tell you. My response is that everyone must make an INFORMED decision based on FACTS AND NOT FEAR and that is what I support for my clients."   
Meike Lawrence RSHom.
A previous post talked about Society of Homeopaths (SoH) members who had been identified as being anti-vaccination. However, identification was based on obvious membership of certain groups. Confirmation was based on very obvious public anti-vaccination statements.

The overall prevalence of anti-vaccination sentiment among SoH members is to a degree unknowable. If a member is silent on the issue, who knows what their position is? But a sampling exercise has been conducted to evaluate how common openly expressed anti-vaccination sentiment is on SoH member websites (or easily found from there). The reasons are explained here.

Context
Without waiting to labour the point, it is very clear that medically unqualified lay homeopaths have no authority whatsoever to talk about vaccination in a healthcare setting. Legally, they are medically unqualified lay persons with no special knowledge. Whilst everyone is entitled to a personal opinion, in many situations it would be highly unprofessional to express them, let alone act on them. Whilst some lay homeopaths may beg to differ, without doubt, it is beyond their competence to discuss vaccinations in any way with (potential) clients. This includes what is said in marketing.

It is suspected that some SoH board members are ideologically opposed to dealing with vaccination issues in any meaningful way.

Important clarification
Anticipating what some homeopaths and their supporters might say, none of the below is in violation of the General Data Protection Regulation (GDPR). The data used is in the public domain. I am not a business entity. Scientific and statistical analysis is excluded from the GDPR. 

Criteria for Inclusion
The SoH has very slightly over 1000 members. The vast majority are based in the UK. Those who are not tend to be UK ex-pats (which can be tricky). There are a very small number who are also regulated medical professionals.

A list of SoH members was obtained using a combination of web scraping tools. The list was loaded into Microsoft Excel. Minimal cleansing of data was performed. Around 52% of members have one or more websites listed. A sample of 200 SoH members and their websites were selected at random.

Those websites that no longer work, are "under construction", have no content or otherwise non-functional are excluded. No attempt was made to determine if members had another functioning website.

Also excluded are those websites that belong to a clinic with multiple practitioners. The reasoning is that the SoH member may not have control of precisely what goes into their advertising. Sites that are run by two (in one case three) homeopaths are included.

One website was excluded on the basis of being in Japanese with no English content.

This left 147 members and their websites.

Website content
The contents of the members' website were evaluated for vaccine related content. None of the websites reviewed had anything positive to say about vaccination.

One of the problems with evaluating whether the statements of a homeopath are anti-vaccination or not is that they often use unclear language. Some words appear to have different meanings in the world of homeopathy. The determination of whether content is clearly anti-vaccination or not is trickier than it may seem.

Some of those in the sample are known to (have) practice(d) CEASE therapy. They are per force anti-vaccination. However, in terms of the claims made, "vaccines cause autism" is treated as anti-vaccination but lesser claims not involving vaccination are not.

Naive comments likening the mechanism of action of homeopathy to that of immunisation were not regarded as evidence of anti-vaccination sentiment in themselves. If would be odd to make such a statement and then say vaccines are bad.

Something that did crop up on a couple of websites' Frequently Asked Questions was "are homeopaths anti-vaccination?" A straight answer would be - yes, some definitely are - but a straight answer was not given. This was treated as anti-vaccination.

It was also noted that some homeopaths had attended talks/training by known anti-vaccinationists. However, it is extremely unlikely that consumers would recognise this. Nor is mere attendance an outright signifier of anti-vaccination sentiment.

17 websites contained anti-vaccination statements.

"Useful" links
Some member websites have dedicated pages of "useful" links but this also includes links to external websites in any context where it is clear that the intention is that consumers can follow them to obtain further information.

The most commonly linked to sites were Arnica, Informed Parent and the CEASE therapy website. In a few cases more aggressively anti-vaccination websites were linked.

No links were made to NHS information on vaccination.

17 websites had these links.


Social Media
Where a website linked directly to a member's Facebook or Twitter account, those were examined. No attempt was made to find social media accounts not linked to. Whilst a few homeopaths did link to other social media such as Instagram, Pinterest and LinkedIn these were ignored. There was a distinct preference for posting on Facebook as opposed to Twitter. 

Some social media posts were obviously anti-vaccination. Sharing of anti-vaccination stories often involved anti-vaccination comments made by the member but when comments were not made, it was still treated as anti-vaccination. Being familiar with Twitter, yes, sometimes uses are ironic in their retweeting but this is not what is going on here.

No pro-vaccination posts were made. Nor were there any critical comments when sharing anti-vaccination content. 

19 websites linked to social media with anti-vaccination content.

Overall
When any indicator of anti-vaccination sentiment is considered, 41 websites were anti-vaccination. That's around 27%.

Because some of those in the sample who don't meet the criteria for being anti-vaccination are known through other sources to be anti-vaccination and in some cases extremely so, the actual prevalence of anti-vaccination sentiment among homeopaths with an online presence is going to be higher than 27%. How high? Impossible to estimate based on current information.

Ouch
To quote again from a blogpost from the (now former) CEO of the SoH Mark Taylor -
The current threat from the Good Thinking Society (Chair, Simon Singh) to pursue a judicial review against the Professional Standards Authority (PSA) is a case in point. Their accompanying statement is a quite deliberate one-eyed commentary, ignoring the evidence and containing statements that are simply false. 
One example: ‘A patient could, via the PSA’s list of accredited practitioners, find themselves consulting with a homeopath who discourages vaccination and believes they can cure children of autism.’ That is simply not true.
How consumers find homeopaths is a bit of a mystery but if they were selecting them at random from the SoH's website they would have >27% chance of ending up with one who is anti-vaccination.

Whilst some might find this amuses, it does present the SoH with a very difficult problem. To quote from their position statement - 
The Society supports informed decision making in regard to vaccination. We recommend that patients seek advice from their GP, as well as organisations that specialise in providing information about this complex issue, so they can make an informed choice for themselves and their children.
This is meaningless. In the section on homeoprophylaxis they also say -
Currently there is no homeopathic alternative to vaccination or anti-malarial drugs which has been proven beyond doubt to be clinically effective. It is therefore unethical for a homeopath to advise a patient against the use of conventional vaccines or anti-malarial drugs.
So, potentially >27% of their members are potentially acting unethically?
The Society expects its members to comply with its Code of Ethics and the above position statements at all times, and any breaches may be treated as disciplinary matters. In order to ensure patient safety and in line with our guidelines, we will check the websites and marketing of all our members on a regular basis to ensure they are adhering to this statement.
This is difficult to believe. 

Further research
It would be possible to increase the sample size by looking at all SoH member sites. This might include determining whether members with non-functioning websites had other functioning websites.

It might also be possible to look at social media that isn't directly linked to by a member's website. It might also be possible to look at claims that they might have made on clinic websites and also third party directories.

Various automated techniques could be applied to the analysis of website content etc. Whilst this would not remove all need for inspection by a human being, it could, for example rule out websites that that have no vaccine related content.

It would be possible to expand the research to members of other homeopathy associations such as the Alliance of Registered Homeopaths, the Homeopathic Medical Association and the Faculty of Homeopathy. There are other associations that register homeopaths too. The constraining factor here is the difficulty of web scraping. Different websites can require different technical approaches. 


Tuesday 24 September 2019

Judicial Review and things

The Good Thinking Society's (GTS) application for judicial review of the Professional Standards (PSA) Authority decision to re-accredit the Society of Homeopaths (SoH) has not yet been granted. The judicial review process is described here but relevant parts will be repeated (it is worth reading in full). The date of hearing of the application is currently unknown. Permission should be granted but there are no guarantees.

Reaction
The GTS made their announcement just after Prince Charles became Patron of the Faculty of Homeopathy. This may explain why there wasn't much of a reaction from the media. There was one media story but that was about it. If permission is granted, it may well be become a media story and it certainly will if the judicial review is heard. Lack of media interest may explain why homeopaths were not up in arms - they tend to be reactive and rarely look outside of their bubble.

This from SoH CEO Mark Taylor is as odd as his pronouncements generally are. 
“GTS is a body that often gets its facts wrong about homeopathy and there are also question marks over how it is funded. It has always opposed the idea of the credibility that PSA accreditation provides for homeopaths.” 
The Society will not be involved in any proceedings and will not incur costs, he added. 
“But we will be giving the PSA all the support that we can to rebuff this challenge.”
Actually, the SoH have already incurred costs. This blogpost from Taylor reveals that he simply doesn't get it.
The current threat from the Good Thinking Society (Chair, Simon Singh) to pursue a judicial review against the Professional Standards Authority (PSA) is a case in point. Their accompanying statement is a quite deliberate one-eyed commentary, ignoring the evidence and containing statements that are simply false. 
One example: ‘A patient could, via the PSA’s list of accredited practitioners, find themselves consulting with a homeopath who discourages vaccination and believes they can cure children of autism.’ That is simply not true.
It is true that a patient could find themselves consulting with a homeopath who discourages vaccination and actively promotes anti-vaccination propaganda. CEASE therapy does claim that autism can be cured and some SoH members did repeat those claims. OK, those claims may have been removed from member websites but there is still a lot of linking to the CEASE therapy website and other places where those claims are made. What an individual member believes is not always apparently from their online advertising, especially when that member is aware than there are restrictions on the claims that they can make.

Taylor goes on to say about Simon Singh (Chair of the GTS) -
He was perfectly convivial but he simply didn’t get it. He seemed to treat the whole issue as a game, something from the university debating society, shocked at my assertion he was part of number of campaigns that could put thousands of people out of work.
A ludicrous assertion to say the least. Taylor goes on to say -
Why in a world where things are never set, where questions have to be asked about everything and compromise is always required, do this handful of sceptics feel able to refuse to listen, whip up unfounded hysteria and be selective with the truth?
The answer, I suspect, lies with them, not us.
It is they who have developed an irrational antipathy to homeopathy, who have become addicted to recreational outrage, and who spend too much time on social media.
So, next time you see another hyperbolic statement or a frenzied rant, be comforted that it is homeopaths who are the professionals, who are constantly using and referring to evidence and working within strict guidelines laid down by agencies to ensure patient protection.
It is the sceptics who have no patients, no understanding of homeopathy and no willingness to compromise, adapt, listen or learn.
The SoH has been furnished with ample evidence of problematic behaviours of members that directly contradicts Taylor. And of course, the whole point of the legal challenge is that patient protection has not been ensured.

The SoH board report from July 2019 says -
MT reported on the possible judicial review being undertaken by the Good Thinking Society against the PSA concerning their accreditation of SoH. While this concerns the Society, it does not involve the Society directly and should not incur costs. MT would seek legal advice on the Society’s position. The whole process is likely to take many months. 
It was agreed that, if the review does go ahead, the Society needs to be prepared for a decision that is not in its favour.
MT = Mark Taylor. Unless the SoH get legal advice for free, they have already incurred costs. 
An invitation only meeting would be held in September to discuss the issues around CEASE. LW would chair and SH would attend. Invitees would all be RSHoms, some CEASE practitioners and some not. Any recommendations or options from this meeting would go to the Board. Some of the issues would be wrapped up in the Scope of Practice Review that was currently being undertaken.
LW = Linda Wicks. SH = Selina Hatherley (and note Vega testing). It is unlikely that any of the attendees understand the issues involved. Mention of Scope of Practice is interesting although because lay homeopathy is not regulated there is no actual legally defined scope of practice. It is not the kind of language that the SoH use and it is likely they mean something else but it is the kind of language used in this blog and in communications with the SoH and other bodies. 

Why Judicial Review?
Whilst the initial decisions to accredit the SoH and other registers such as the Complementary and Natural Healthcare Council (CNHC) and the Federation of Holistic Therapists (FHT) were widely criticised, the PSA's hands were tied by weaknesses in legislation. It claims that it is not allowed to consider the validity of the therapies that an accredited register covers. To do so would be ultra vires.

The PSA's decision to re-accredit the SoH is highly questionable on a whole number of grounds that have nothing to do with the validity of homeopathy. 

It is important to note that there is no direct mechanism for a third party to challenge PSA decisions regarding accredited registers. The registers themselves can appeal decisions but not anyone else. Surprisingly, the PSA are not directly answerable to the Department of Health and Social Care (DHSC) even though it partly funds the accredited registers scheme (it is supposed to be self-financing but it is years away from that at best). It is "answerable to Parliament" but this is not a route of appeal. There is not an Ombudsman with the correct remit either.

The Pre-Action Protocol for Judicial Review from the Ministry of Justice stresses that court should be a last resort and alternative dispute resolution should be pursued. Theoretically, the PSA are able to mount a targeted review of an accredited register. This might satisfy the grievances of the GTS and to quote from PSA guidance -
3.3 If the Accreditation team’s in-year monitoring raises sufficient concerns, or if information is shared with us that raises concerns, a targeted review may be initiated. The process and possible outcomes of this targeted review are the same as for a targeted review initiated at annual review. An in-year targeted review will not negate the need for an annual review. 
The PSA have not instigated a targeted review. It would appear that concerns raised were insufficient in their view to do so.

Legal Duty?
To quote from the GTS Crowd Justice page 
The PSA has said that they have a very limited role in accrediting organisations such as the Society – which is focused on governance and administration. We have responded to reiterate that when deciding whether to accredit the PSA is obliged to consider whether organisations such as the Society include individuals who offer harmful and discriminatory therapies, such as CEASE therapy. This is extremely important because PSA accreditation provides a stamp of respectability and endorsement which – in the PSA’s own words – enables the public to “avoid bad apples”. In fact, the PSA’s stamp of approval is likely to be directing more desperate parents towards CEASE therapy which is precisely the opposite of what should be happening.
As has been discussed before, the PSA must have due regard for the Equality Act 2010. They have a Public Sector Equality Duty. There is no explicit general duty on public sector bodies regarding public health or public safety beyond the Health and Safety at Work etc. Act 1974. There is a public health duty on the NHS, local authorities and the Secretary of State for Health and Social Care but the PSA is no longer answerable to the Secretary of State. 

As stated in the National Health Service Reform and Health Care Professions Act 2002 with regards to the statutorily regulated professions -
(2)The general functions of the Authority are— 
(a)to promote the interests of users of health care, users of social care in England, users of social work services in England and other members of the public in relation to the performance of their functions by the bodies mentioned in subsection (3) (in this group of sections referred to as “regulatory bodies”), and by their committees and officers, 
(b)to promote best practice in the performance of those functions, 
(c)to formulate principles relating to good professional self-regulation, and to encourage regulatory bodies to conform to them, and 
(d)to promote co-operation between regulatory bodies; and between them, or any of them, and other bodies performing corresponding functions.
  
(2A)The over-arching objective of the Authority in exercising its functions under subsection (2)(b) to (d) is the protection of the public.

The remit of the PSA was expanded to cover accredited registers by the Health and Social Care Act 2012. It was one of the most contentious attempts to "reform" the NHS ever undertaken. It states that the functions of the PSA re accredited registers are -
1) The Authority has the following functions— 
(a) to promote the interests of users of health care, users of social care in England, users of social work services in England and other members of the public in relation to the performance of voluntary registration functions,
(b) to promote best practice in the performance of voluntary registration functions, and 
(c) to formulate principles of good governance in the performance of voluntary registration functions and to encourage persons who maintain or operate accredited voluntary registers to conform to those principles.

There is no over-arching objective of protection of the public written into it. 

Risk Matrix
One of the papers for the PSA September board meeting is their risk matrix.  One risk identified is reputational damage to due to -
Criticism of the Authority in the face of poor practice / controversial therapies by one or more accredited regulators.
This risk has existed since the start of the scheme. The PSA see the likelihood of this risk as increasing. Mitigation?
Robust accredited registers processes, including QA checks 
Clear explanation of the programme’s role – accrediting registers not therapies 
Regular engagement with the organisations 
Active management of the media when necessary
Perhaps the first might have some effect on mitigating the risk but the others?

But...
It is probably better to let the judicial review play out than speculate on what might or might not happen during/as a result of it. Whilst there are all sorts of potential implications for the PSA and the accredited registers scheme, there is only one certainty.

At some point, the SoH will have to go through the accreditation process again. Whether it is part of a targeted review, a re-run of the annual review or just an annual review doesn't matter that much. What matters more is if it goes before a moderator or a full accreditation panel.

The SoH have recently indicated their intention to renew accreditation.

Re-running the accreditation process
The PSA would be ill-advised to take the same approach to accreditation as they did the last time around. It would increase the risk of reputational damage.

Being focused on "governance and administration" is all very well but the same criticisms of, for example, the ISO 9000 standard could be levelled at the accredited registers scheme.
If you just want the certificate on the wall, chances are you will create a paper system that doesn't have much to do with the way you actually run your business.
This might be said of certain registers.

It is suggested the PSA pay special attention to Standard 2 of the Standards for Accredited Registers -
Standard 2: the organisation demonstrates that it is committed to protecting the public and promoting public confidence in the occupation it registers.
The organisation will need to demonstrate that its purpose and directives are focused on public protection. Additionally, the organisation will need to show that in carrying out its voluntary register functions public interest is paramount and that professional interests do not dominate or unintentionally subvert that interest. 
Evidence of this might include board or committee discussions where issues have been debated and conflicts of interest identified or the ethical interests of parties weighed in the balance; decisions made about admittance to the register where the documented rationale shows due consideration of public protection; outcomes of complaints; particularities of governance arrangements. 
Having meetings, setting up committees, conducting reviews etc are not in themselves evidence of focus on public protection or that public interest is paramount. Too often leadership does these things to satisfy some external requirement. They can be tactics to delay making a decision. The setting up of committees/reviews can be about leadership distancing themselves from something unpopular.

Yes, the SoH were forced by the PSA to (grudingly) implement an action plan to deal with members offering CEASE. But the plan has not achieved overall compliance. This was going on when the ASA enforcement notice was sent out, which both the PSA and SoH knew about before it was sent.

It is all very well for the SoH to have (weasel-worded) position statement on CEASE, homeoprophylaxis and vaccination but if it does not enforce them, they aren't worth very much.

One additional problem for the SoH is that more information has come to light about both the potential risks posed by their members and their prevalence. "Bad apples" have been identified. It's not just CEASE therapy and Homeopathic Detox Therapy. Homeoprophylaxis is openly promoted by only a few members but anti-vaccination propaganda is not uncommon. Questions have been asked about the competence of members to deal with mental health issues. The business of offering bizarre therapies other than homeopathy is awkward for the SoH but is not something that will excite the media in itself (but doesn't help when there is reporting for other reasons).

Homeoprophylaxis is rare. Exactly how prevalent anti-vaccination sentiment is among SoH members is unknown. It's not always openly expressed. Unlike with CEASE therapy, there isn't a list of those who've signed up for training in anti-vaccination disinformation. Of course, CEASE is anti-vaccination but not all of those who are anti-vaccination offer CEASE. 

Another is problem that is it clear that the SoH are either ineffective in mitigating/managing these risks or simply don't want to. In particular, no obvious action has been taken against identified "bad apples", they remain members and the problematic behaviours continue.  One result of taking action could be to lose members, either through expulsion or voluntarily leaving because they don't like the direction the SoH is taking. 

Whilst it is unlikely a new CEASE therapy/HDT is going to come along soon, it's clear that the SoH did not recognise CEASE as a risk and to some extent promoted it. They should have recognised it as a risk as soon as they applied for PSA accreditation. It is questionable whether they would recognise new risks or if an existing risk is increasing.

Some might say that the SoH has no reputation worth speaking of to be damaged. This isn't strictly true if you accept that PSA accreditation leads public credibility to them. It is unknown what mitigations the SoH have in place re reputational damage but this recent article about dealing with the media includes - 
Pamela Stevens, the Society’s Marketing Manager, said the My Voice guidance was aimed at helping members whose experience of the media may be limited. 
“Homeopathy makes the national news from time to time and recently some members have had particularly negative experiences. We’ve compiled this guidance to equip our members to deal with journalists who may be seeking a sensational story so they can avoid feeling under pressure and, where appropriate, respond with authority.”
It is unknown what the guidance says. Although the risk is external, a main causes are the claims of members and the SoH's failure to combat them.

Of course, the reputation of the SoH is not something that directly impinges on the PSA. It's not something that it can control either. 


Outcomes
Not re-accrediting the SoH might be a bridge too far for the PSA. It's unknown how much store the DHSC or politicians place in the accredited registers scheme but it might not be politically palatable. It would likely raise questions about why the SoH was accredited in the first place.

It is difficult to judge whether the SoH would appeal such a decision. The SoH make a big deal out of accreditation but the June 2018 board report states -
SC asked whether there would be a point when it was not feasible for the Society to continue with the re-accreditation process. The feedback currently from  members was generally positive and members did value the Society being accredited by the PSA. 
Further discussion took place about the advantages and disadvantages and the organisational structure of the PSA. 
MT proposed that it would be sensible to analyse and reassess the whole accreditation process at some point. This would be something to consider inserting into the Strategic Plan.
SC = Sue Crump.

It's important to note that the decision to remove accreditation is made when "the Accreditation Panel finds that the organisation does not and cannot continue to meet one or more of the Standards." Read one way, accreditation is only removed if a register has a complete inability to meet one or more Standards. This is very clear cut in the case of financial non-viability, less so for other issues. 


The PSA has a number of options open to it in terms of dealing with a problem register short of removing accreditation. It can can suspend accreditation whilst the register fixes things. This may involve the register and its members having to remove mention of PSA accreditation and the logo from advertising. If it can't provide evidence of fixing the problem within 10 days, accreditation will be removed.

Alternatively, the PSA can accredit conditionally as it did with the SoH in 2018. If a register does not meet the Conditions, it can have its accreditation removed or suspended. The PSA hasn't placed Conditions on any register recently. There could be a number of reasons for this - for example, registers that have been accredited for a number of years have addressed major shortcoming. Even so, conditional accreditation of the SoH is a strong possibility. But what kind of Conditions? How long would the SoH have to meet them? Very difficult to say. 

An adverse Court ruling against PSA accreditation of the SoH because of CEASE would force the PSA into a position of demanding that the SoH prohibit it if they want to retain accreditation. But even without such a ruling because of the ASA enforcement notice, the associated media reporting and other factors, issuing mere Recommendations would invite criticism. Nor would it look good if the PSA accept SoH fiddling around with changing the name of CEASE etc as dealing with the issues.

Would prohibition of CEASE be too much for the SoH?

How anti-vaccination disinformation is dealt with is going to be very interesting. It gives nothing away to say that a website sampling exercise is being conducted to gauge how prevalent openly expressed anti-vaccination sentiment is. 











Tuesday 17 September 2019

Antipathy Towards the Advertising Standards Authority #4

This blog has looked at homeopaths' dislike of the Advertising Standards Authority (ASA - but use here may include Committees of Advertising Practice (CAP)) several times before (here, here and here). It also discussed the ASA statement on CEASE as well as the associated enforcement action (here and here). Nothing has really changed but a few things have come to light that add a new perspective.

Steve Scrutton
Some readers will be familiar with Scrutton and his problematic grasp on reality. Scrutton is a director of the Alliance of Registered Homeopaths (ARH). Supposedly he has responsibility for "Media and Communications". Scrutton has an ASA ruling against him. Which he chose to ignore.

Scrutton has a blog. He recently posted something about the ASA ruling. It really needs to be read in full to understand how pompous Scrutton is but...
Some of my detractors use my confrontation with the Advertising Standards Authority (ASA) to attack me, so it might be useful to outline what happened - not to defend myself, that's unnecessary, but to demonstrate how homeopathy deniers work in order to support the conventional medical establishment, and to undermine homeopathy, and other natural therapies.
It would be possible to make a sarcastic comment. This is telling though -
The ARH decided that it was not going to cave in, although we would check to our own satisfaction that adverts conformed with our well established advertising guidelines. Facing up to ASA was to be a personal decision by each individual homeopath, but any homeopath who decided to stand firm against them would be fully supported in doing so.
As far as is known, despite numerous complaints to the ARH over many years, they have never taken any action against advertising by their members. The threat of referral to Trading Standards re CEASE claims has lead to some modifying their claims but some holdouts exist. In terms of the "well established advertising guidelines", well, they don't seem to have any bar what are in their Code of Ethics -
36 All advertising must be published in a way that conforms to the law and to the guidance issued in the British Code of Advertising Practice. 
37 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. 
Oops. The ARH effectively endorsed non-compliance with their own Code of Ethics by members. 

It's known that the Society of Homeopaths (SoH) did have meetings with the ASA but Scrutton's blog tells us that the ARH was present at some, if not all, of those meetings. Scrutton then goes on to reveal how deeply invested in conspiracy theories he is -
What difference did the adjudication make? None whatsoever, as far as I could judge. Many of my patients knew about it, and they recognised the adjudication for what it was - the machinations of a pharmaceutical industry in which they had no trust or confidence it. So I know that the 'authority' of ASA has been damaged, far more than my reputation! 
Moreover, I hold ASA in complete and utter contempt for allowing themselves to becomes the creature of the dishonest and corrupt pharmaceutical industry
Scrutton does have a reputation but it is not what he thinks. ASA rulings do have an impact on larger marketers in terms of adverse publicity and also some media will refuse their advertising. The Post Office refuse to deliver mail shots and so on. 

Scrutton comes out with the usual line about the ASA being a limited company with no legal powers and so on. It is true that the ASA is funded by a levy on some types of advertising but does so at a distance. The Courts view it as independent even if Scrutton does not. 

The advertising of prescription only medicines (POM) to the public is not permitted - although it is permitted to specialist audiences. The advertising of General Sales List medicines (GSL - also known as over the counter) is permitted but is mostly for branded products. The advertising of medicines is partly controlled by the Human Medicines Regulation 2012 which is the remit of the Medicines and Healthcare Product Agency (MHRA). In practice, the MHRA deal with advertising of POMs, the ASA advertising of GSL products (although if it comes to prosecution, that is the remit of the MHRA). Also, many GSL manufacturers are members of the Proprietary Association of Great Britain (PAGB). PAGB produces lots of guidance on advertising compliance. It also pre-vets member advertising. The ASA do rule against "big pharma" as this ruling against Pfizer shows but it is rare because the industry has a good understanding of what claims are permitted. Perhaps the reason that there are so many rulings against CAM practitioners and products is due to a lack of understanding of rules?

Scrutton claims "The biggest advertisers are the pharmaceutical industry, and related industries, so no doubt the dominant source of ASA's income." Really? Far from it. This isn't even true in the US.

There is something else Scrutton doesn't understand which will be discussed later.

More moaning
The late Richard Eaton was a barrister but retired at some point. He was involved in the running of his wife's reiki business. Eaton was involved with the College of Medicine (aka the Mike Dixon Show). Despite Eaton's legal background, he displayed a very odd attitude to advertising regulation. 

This article appeared on the Positive Health website but is likely to have appeared in other places in a modified form. It's tedious to read but it moots change to the way that the ASA is run but the last paragraph -
I hope this Article is perceived as a first step towards a strategy to regulate and bring up to date the exercise of power by the ASA, both to protect the businesses of CAM practitioners and to preserve the rights of CAM Patients to have access to a CAM practitioner and treatment of their choice.
Eaton recognises that the ASA is the established means of dealing with misleading advertising. His arguments are different from those of the SoH members who wanted to mount a legal challenge against the ASA as the established meanings and set up one or more others. Even so, Eaton is suggesting that CAM practitioners deserve special treatment.

The All Party Parliamentary Group for Integrated Healthcare (PGIH) released a particularly poor report Integrated Healthcare: Putting the Pieces TogetherIt is worth pointing out that All Party Parliamentary Groups (APGs) are informal bodies. They have no official standing (although some APGs are influential and well regarded). They are not Select Committees. Some have tried to exaggerate the importance of the report despite it saying -
This is not an official publication of the House of Commons or Lords. It has not been approved by either House or its committees. All-Party Groups are informal groups of Members of both Houses with a common interest in particular issues. The views expressed in this report are those of the Group.
PGIH invited CAM bodies, practitioners and patients to make submissions for the report. It's essentially a cobbled together wish list combined with weak self-justifications. The report makes much of potential savings to the NHS but there is nothing in the way of financial analysis to justify this. Whilst the SoH's submission is no longer on their website this article gives some indication of what was in it. Whether the SoH are typical of those other CAM bodies is unknown. What is in the report is far less strident. Among the headline recommendations -
The ASA should ensure it is fully transparent in decision-making regarding complementary, traditional and natural healthcare therapies, taking advice from independent experts in the field, whilst allowing reasonable claims to be made based on qualitative research, documented case studies and patient testimonies. The government should ensure that information produced on this sector is balanced and objective, and based on a broader view of evidence, to help patients obtain accurate information through official sources instead of those of unknown validity and quality.
In more detail -
Advertising is a common way for patients to seek services. Advertising controls are necessary, and it is fair to insist that therapists do not make unrealistic claims and are accurate about qualifications. However, there are concerns that advertising regulations are too restrictive and are limiting how complementary, traditional and natural healthcare practitioners can describe their treatment, how they can display client personal outcomes from treatment, and whether it has traditional usage. 
And -
As such, the Committees on Advertising Practice (CAP) and the Advertising Standards Authority (ASA) should adopt a pragmatic approach that accepts other forms of evidence other than double-blind RCTs. It should allow reasonable claims to be made based on qualitative research, documented case studies and patient testamonies where no incentive has been given and it represents a true account of the patient’s own experience.
Again, the plea for special treatment. Reasonable? That word has multiple means but just, rational, appropriate, ordinary or usual in the circumstances are some of them. It would not be just, rational or appropriate to allow one industry sector special consideration when others are not. It is a plea to allow the subjective as evidence.
In addition, it would be advisable, as the ASA has no specific expertise in complementary, traditional and natural therapies, to ensure that it is fully transparent in decision making and takes advice from unbiased and independent experts in the field when setting guidance in this area.
It is likely that PGIH et al defintions of "unbiased" and "independent" differ from most. As for transparency? It is not clear what is meant by this but it is suspected homeopaths etc want to know the identity of any expert who's opinion called on and scream "biased!" 

Actegy Ltd
Actegy sell medical devices that they make dubious claims for. They have been the subject of four separate ASA rulings - 
Actegy initially failed to gain permission for judicial review of the 2018 ruling. Permission was later granted but Charles Bourne QC found the ASA had no case to answer. Also in question was the decision of the Independent Reviewer not to review the ruling. The ruling whilst not related to homeopathic services or products is instructive.

Judicial review? As the ruling explains, it has long been accepted that although the ASA is a non-statutory body, independent of both the government and the advertising industry, it rulings are amenable to judicial review. This is unusual but the argument is that the ASA is carrying out the functions of a public body. This article is helpful - see 19.

The ruling sets out the legislative background for medical devices. Medical device regulation was discussed on this blog in a different context. It then goes on to discuss advertising regulation and the underpinning legislation. Interestingly, it concentrates mostly on the Unfair commercial practices directive - Directive 2005/29/EC (UPCD) rather than the Unfair Trading Regulations 2008 which is its transposition into UK law. The Regulations 2008 do say in Section 19.
(4) In determining how to comply with its duty of enforcement every enforcement authority shall have regard to the desirability of encouraging control of unfair commercial practices by such established means as it considers appropriate having regard to all the circumstances of the particular case.
"Established means" is understood to mean the ASA.

The challenge was made on the basis that -
    i) The ASA maintains a test or approach for assessing whether or not efficacy claims made for a medical device in an advertisement are substantiated which is not required by the CAP Code and is anyway disproportionate and/or unreasonable.
    ii) The ASA applied a disproportionate, irrational and/or unfair approach and/or standard when assessing whether or not there was adequate substantiation for the efficacy claims made in the advertisement.
    iii) The ASA's conclusion that the efficacy claims made in the advertisement were not adequately substantiated was irrational.
What does the CAP Code say about substantiation? 
CAP 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.
CAP/ASA guidance on substantiation is copious but here is a good place to start.

Bourne QC in response to claim 1 states that Actegy's lawyer would have to prove that the ASA's evidence requirements were incompatible with the UPCD and interfere with Actegy's rights under EU law. The arguments are quite laboured but Bourne concluded -
Having found that the ASA's approach in general is proportionate because it does not depart from the requirements of the UCPD, I also find, unsurprisingly, that it satisfies the test of rationality. It cannot be said that no reasonable regulatory authority could impose a requirement of rigorous and relevant evidence to substantiate claims made for the efficacy of medical devices.
Bourne considered claims 2 and 3 together. The arguments made by Actegy's lawyer are less interesting but Bourne's responses are -
The issues which the ASA identified – equivalence of devices, mode of use and consumer groups targeted, methodological issues including blinding and sample sizes – were genuine issues acknowledged by both experts. Dr Heller's evidence at least shows that there is expert support for the conclusions reached by the ASA on those issues. I therefore consider that those conclusions were rational in the Wednesbury sense. I see no unfairness in the way in which they were reached. I have already explained why I do not consider that a proportionality test needs to be applied but even if it were, it would not produce a different result. The ASA's analysis of the evidence was in pursuit of the legitimate objective of consumer protection, was a suitable or appropriate means of pursuing that objective and was necessary in that it was not more restrictive than any alternative and suitable means of pursuing that objective, no other such alternative having in fact been identified. 
Nor was there any legal error in the ASA's refusal to be persuaded of the device's effectiveness by its CE certification. It was, in the end, common ground that such certification for the purposes of the MDD does not automatically satisfy the requirements of the UCPD, not least because of the considerable differences in the way in which the evidence is assessed for the purposes of those two regimes. It was therefore lawful for the ASA to carry out its own assessment. 
The second and third grounds of challenge therefore fail.
What is interesting here is that claims included in the certification of medical devices can be found to be misleading. Effectively, the requirements of the UPCD trump the Medical Devices Directive. 

Thought experiment 1
The likelihood of an individual homeopath challenging an ASA ruling against them via judicial review is extremely low. The vast majority do not have the money and it is even more unlikely that they would be granted Legal Aid. The various homeopathic practitioner associations do not have the money either and they are unlikely to come to the financial aid of a member. Whilst the British Homeopathic Association (BHA) and the Friends of the Royal London Hospital for Integrated Medicine do have considerable reserves, they are very unlikely to fund an further judicial reviews given the BHA's experiencesBut imagine that an application for judicial review was made and permission was granted...

As will be explained, even if judicial review were granted, a ruling against the ASA is extremely unlikely (which may be another reason why it has not be attempted). Humiliating failure is a more likely outcome. 

For those interested here are some ASA rulings involving homeopathy (also see Steve Scrutton above) -
Rulings do not stay on the ASA website forever. For example, there was a ruling against Steve Scrutton in 2012 that is no longer there. The rulings against the SoH and Homeopathy: Medicines for the 21st Century are qualitatively different from those against practitioners. They deal with much broader issues for one thing.

The ASA generally only rule on what is complained about. From experience, the more extensive a homeopath's website, the more they use social media, the greater the number of problem claims (although sometimes they are just verbose and self-important). The more claims the ASA has to investigate, the longer a ruling will take.

If a homeopath disagrees with a ruling, they can appeal to the Independent Reviewer. Indeed, there is an expectation that all routes of alternative dispute resolution are explored before judicial review is applied for.

Responses, if any are made, are very naive. "I was only providing information" and free speech arguments have been seen. These arguments do not apply to advertising. What is considered advertising can be unclear in some cases but when a website, email, leaflet etc promotes the business of a homeopath it is advertising. Whether or not it paid for does not come into it. A challenge on those grounds would be futile.

Rulings can involve discouraging essential treatment. The ASA does understand that there are risks of potential harm. The relevant section of the CAP Code states -
CAP 12.2 
Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered (see rule 12.11).

Health professionals will be deemed suitably qualified only if they can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of members' skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.
A homeopath could challenge a ruling on that point. A member of the SoH might point to its accreditation by the Professional Standards Agency (PSA) as being sufficient to be deemed as a "suitably qualified health professional". This has been a source of concern. Not just about SoH members - this also applies to members of the Complementary and Natural Healthcare Council (CNHC) and the Federation of Holistic Therapists (FHT). Is it a "get out of jail free card" or is it more nuanced than that? The word "relevant" may be important. It must be remembered that many members of the SoH, CNHC and FHT offer therapies that are not covered/validated by these bodies. In law, certain acts are restricted to certain statutorily regulated professions.

The claim of an individual to be able to treat a certain condition doesn't necessarily specify with what therapy. Consider the case of a doctor who claims that they can treat/prevent malaria. Given that there are pharmaceutical treatments, this is not an unreasonable claim. But if that doctor claimed to treat/prevent malaria with homeopathy?

Even if the ASA do regard members of PSA accredited registers as health professionals, they would not regard other medically unqualified lay persons as such (although there may be a few exceptions). Members of PSA accredited registers are probably less likely to discourage essential treatment than those who are not.

To a very large degree advertising that discourages essential treatment is also making claims that can not be substantiated. Either in terms of actually discouraging treatment (eg claiming that medical treatments are harmful) and/or suggesting erroneously a therapy can be used for treatment of a certain condition. Substantiation is at the heart of every complaint about homeopaths. ASA rulings on homeopaths tend to focus on (direct or implied) claims made for treatment of named conditions by homeopathy rather than claims made for a particular homeopathic remedy (which tend to address a range of symptoms rather than conditions).

Remember that an ASA ruling would likely be regarding claims to treat a specific condition(s). Homeopaths might point to individual peer reviewed randomised controlled trials (RCTs) or systematic reviews (SRs) as evidence of efficacy for that condition. The problem there is that there are no compelling RCTs or SRs for any condition. They tend of be of very low quality and biased. Also, homeopaths have a habit of regarding inconclusive results as positive and ignoring negative evidence. Cherry-picking.

The ASA (or an expert used by them) is going to look beyond one positive RCTs. It is going to consider quality, bias, etc. Challenging a decision by the ASA made on the (sort of) totality of evidence would have to be about ASA acting unreasonably/irrationally in giving undue weight to certain RCTs. It is important to remember that witnesses are rarely called and cross-examined in judicial review hearings. Parties would normally submit reports by expert witnesses which both sides see. Rebuttal of a pro-homeopathy expert report would not be difficult.

A challenge as per Actegy that the ASA sets the bar too high in quality of evidence could be made. That it goes beyond the requirements of the UPCD and interferes with their rights under EU law. The latter might introduce the issue of lay homeopathy being prohibited in many EU member states and even where it is permitted there can be restrictions on advertising that do not stem from consumer protection legislation but it is unlikely to have direct bearing on any hearing. 

That kind of challenge might revolve around the contention that homeopathy is not amenable to RCTs, thus the ASA's requirement for them is unreasonable etc. The argument tends to run along the lines of "oh RCTs test single remedies!" whereas homeopaths will use different remedies for the same condition in different people. This is nonsense. It is perfectly possible to design a double blinded trial of homeopathy with individualised remedy selection and they do exist.

The argument that RCTs are not suitable for homeopathy often goes hand in hand with arguments that other forms of evidence should be considered. The ASA do not require RCTs for substantiation of many types of claim but they are objective, specific in scope, quantifiable and thus verifiable claims. A good example would be any claim that relates to the physical characteristics of a product. But what kind of evidence do homeopaths want to be considered?

There is a thing called the "evidence pyramid" or hierarchy of evidence -

Evidence-based medicine pyramid. The levels of evidence are appropriately represented by a pyramid as each level, from bottom to top, reflects the quality of research designs (increasing) and quantity (decreasing) of each study design in the body of published literature. For example, systematic reviews are higher quality and more labor intensive to conduct, so there is a lower quantity published. 


This submission from a homeopath to as part of the Science and Technology Committee Evidence Check 2: Homeopathy is possibly indicative of the kind of evidence homeopaths would like to see considered. Some of the cited papers aren't directly concerned with measuring actual outcomes. There are a couple of observational studies with comparison groups but the often cited Homeopathic Treatment for Chronic Disease: A 6-Year, University-Hospital Outpatient Observational Study doesn't even bother with comparisons which is a fundamental weakness (although it has multiple other weaknesses).

The NHS makes some use of Patient Reported Experience Measures (PREMs) and Patient Reported Outcome Measures (PROMs). A good explanation of them can be found here. Another weakness of that study is that the PROMs were completed during consultation. It states -
Collecting the data poses additional challenges that should be considered. On site feedback collects data when the patients may not be in a physical or psychological state to give accurate opinions of their experience of health status, in addition to missing information relating to discharge and recovery. Patients may also be concerned about the negative impact of their answers on the care given by health care providers and adjust their responses accordingly. Post-contact feedback relies upon an adequate sample size of patients filling out the questionnaires, with potential for low-response rates. Time constraints may also affect the data collection process, with disruptions to outpatient and inpatient clinical encounters in order to distribute the questionnaires. To reduce bias, completing the questionnaires at home, in the patient’s own time may be beneficial.
That Bristol study? The outcomes were recorded during consultation by clinicians. 

Case reports and case series are useful in a medical context but their weaknesses are well understood. Case reports by homeopaths are often couched in esoteric and meaningless terms. There are also a growing number of predatory journals that publish case reports and series.

There is considerable irony that expert opinion is at the bottom of the pyramid when the plaintiff would almost certainly depend on an expert to write a report to justify the lowering of the evidence bar.

Something that might crop up is that homeopathic remedies registered under the National Rules Scheme are permitted indications. The bar in terms of evidence is lowered considerably compared to pharmaceutical products. It might thought that a homeopath could make claims based on those indications but -
You can claim that your product is used within the homeopathic tradition for the relief or treatment of minor symptoms and conditions which don’t require the supervision of a doctor.
Such restrictions applied to the practice of homeopathy would necessarily limit permitted claims to those made for National Rules Scheme products and de facto require disclaimers. It is unlikely to be considered relevant though.

Thought Experiment 2
Are the decisions by the ASA to carry out enforcement actions amenable to judicial review? Very probably.

In the case of the CEASE enforcement action, the non-permitted claims were spelled out very clearly but there was a prior enforcement letter in 2016 that was much broader in scope.
The ASA’s current position, which was established through a number of ASA rulings, is that homeopaths may not currently make either direct or implied claims to treat medical conditions. 
In arriving at this position, the ASA considered a significant body of evidence which sought to demonstrate the efficacy of homeopathy in treating a range of medical conditions. On the basis of expert advice, the ASA concluded that the evidence was insufficient to support any advertising efficacy claims.
As the letter explains and also mentioned above, they did "work" with the SoH (but not the ARH) on this. How much warning the SoH (and ARH) got before the letter was sent is unknown but application for judicial review could have been made. Potentially this could have stopped the letter being send until the application had been considered but the ASA might have pressed on anyway (because application would have been very unlikely to be granted).

The arguments that could be presented are largely the same as for challenging an individual ruling but it might be thought that the position that evidence was insufficient for any claim of efficacy might be more vulnerable. If there was compelling evidence of efficacy for just one condition, then the whole ASA position is invalid? It's a hypothetical question as such evidence doesn't exist. Major SRs would have picked it up if there were.

As for a challenge based on the supposed setting of too high an evidence bar for homeopathy? Trying to argue that as a whole, for all conditions is a non-starter. To be clear, lowering the bar for certain series conditions simply can't be done. Especially conditions in which survival is dependent on regular medication. Type 1 diabetes is the most well-known example but there are others. Varying required levels of evidence for evidence for different conditions is impractical for many different reasons if for no other reason that individual conditions can vary in severity, even those that are thought of as mild.

No even slightly credible expert that homeopaths might call on would take the position that homeopathy is efficacious for every condition. Indeed, some come out very strongly against certain claims (see the late Dr Peter Fisher here).

The business of homeopathic remedies registered under the National Rules Scheme being permitted indications might be thought relevant but again, they are not claims of efficacy. 

Some homeopaths said that the letter was "threatening" and "bullying". What does it say that is so menacing?
We must emphasise that it is our objective to work with and support advertisers to achieve compliance, and the application of sanctions against those advertisers who are unwilling or unable to comply will always be our last resort. 
However, if you are unwilling or unable to appropriately amend your advertising, possible sanctions could include featuring your name and non-compliance on a dedicated section of the ASA website and, if necessary, in an ASA advertisement appearing on an appropriate page of an internet search website. We can also ask internet search engines to disable your paid-search ads, where those ads link directly to non-compliant content. 
The ultimate sanction is referral by the ASA to the Trading Standards under the Consumer Protection from Unfair Trading Regulations 2008. Trading Standards is the legal backstop for the ASA. What this means is that where the threat or application of our sanctions have failed to achieve compliance, the matter may be formally referred to Trading Standards. Trading Standards will consider cases to determine if there are breaches of relevant legislation and take appropriate action in accordance with its own enforcement policy.
Could this "bullying" letter be challenged? Whilst the sending out of the letter represents a decision, the above text does not. It's a statement of the ASA approach.

Thought Experiment 3
As described here, many homeopaths offer even less evidenced therapies in addition to homeopathy. Whilst there may some evidence for adjunctive use of some therapies (including homeopathy) alongside conventional treatment, there doesn't seem to be any for adjunctive use of other CAM therapies alongside homeopathy.

As discussed above, the homeopathic associations would be unlikely to fund application for judicial review on the behalf of a member but there is the question of whether they would be even less likely in the case of a ruling against re multiple therapies? There is the curious business of the SoH saying on one hand that they will support members but on the other than they will not concern themselves with the offering of other services.


Putting ideas in their heads?
Possibly, if the idea had not occurred to them (or their legal advisors - if they took advice) before. But the costs involved and almost certainty of failure should be deterrent against applying for judicial review.

It might excite the likes of the homeopaths mentioned here and Homeopathy International (HINT). Two of the homeopaths firstly mentioned have left the SoH and now belong to HINT. Whilst fringe homeopaths did convince the SoH to seek legal advice in the past, whether they could convince an association now is unknown.

Homeopathy does have self-defeating and even self-destructive tendencies though...