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...

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