• The Works

The Bell Tolls for Quack Charities?

So after nearly five years of effort, I am rewarded with a response from the Charity Commission regarding charities which make misleading claims about the treatment of ill health. Is it what I wanted? The answer is “partly”, but it depends on how the Commission applies its new guidance.

But first, a recap. After years of frustration, with the Commission repeatedly brushing off my complaints, my friends at The Good Thinking Society stepped in and issued a legal challenge. This was on the basis that the Commission was failing in its statutory duty to enforce The Charities Act 2011. The Commission didn’t deny this, but made excuses about priorities and resources, with which one could not entirely disagree. But the Act does not provide scope to pick and choose which bits of enforcement to carry out. So the Commission undertook a public consultation, and promised to publish a report and updated operational guidance. Some 18 months later than their promise, this actually happened on 11th December. See my previous posts for more detailed history.

My fundamental argument was that if a charity existed to provide and/or promote an approach to ill health which lacked robust evidence, then the legal requirement to provide public benefit must have been breached. I should mention in passing that The Charities Act defines charitable purposes and public benefit separately. Permissible purposes include “the advancement of health or the saving of lives”. However this is not sufficient to establish that the organisation is a charity. The Act states that “it is not to be presumed that a purpose of a particular description is for the public benefit”, ie that said benefit must be established separately. The Act also confirms the primacy of the Commission’s guidance, as to its role in defining what is meant by public benefit. This aspect is crucial in the interpretation of the Commission’s latest publications.

My initial reaction to these documents was negative. I naturally started with the Outcome Report, and this contains a great deal of what I have called before weasel words. Yet the opening paragraphs give cause for optimism. For example:

The changes we are making will mean that we may ask for different information from some new applicants for registration, and we will need to consider whether any currently registered CAM charities may be affected as a result.

But I am worried about this:

Second, our review has established that evidence of medical efficacy (such as findings generated from scientific trials) that a certain treatment has measurable beneficial medical impact is not the only way in which a CAM organisation might demonstrate that it provides public benefit.

By mentioning `scientific trials’ it appears that unscientific approaches might be acceptable. This to an extent parrots the quack argument that science is not appropriate for assessing CAM. But in the next paragraph we have:

In such situations, evidence of benefit may come in the form of outcome reports by patients, or observational studies based on patient responses.

This sounds dangerously like patient testimonials, in other words anecdotes. Is this what is meant? Not if the following paragraph is to be believed, where the Commission cites “robust patient reported outcome studies”. I’ll have more to say about this later. I am rather more worried by this catch-all statement:

As our updated guidance makes clear, the categories of evidence we will consider are not exhaustive, and we will consider any evidence which is appropriate and relevant to the claims which an applicant makes.

This sounds as if the Commission will decide itself what evidence is appropriate, without taking expert advice.

This paragraph on page 5 could be a rod for the quacks’ backs:

Our safeguarding strategy makes clear that a charity should be a safe and trusted environment. With regard to CAM organisations registered as charities, we will take very seriously any concerns about the safeguarding and treatment of people, including in the way that a treatment and its benefits are described to potential beneficiaries. So while registration as a charity is a meaningful and important recognition of the potential public benefit provided by an organisation, it in no way precludes our taking regulatory action where we have concerns about a charity’s activities and operations or about trustees’
oversight of their charity’s work.

As has been covered by the excellent blog UK Homeopathy Regulation, there is a huge safeguarding issue with homeopaths who practise so-called CEASE therapy, and/or claim to treat autism. Any charities who work with such homeopaths will fall foul of this principle.

There does not seem to be a great deal of commitment to cleaning up the Commission’s act regarding CAM charities:

Our preliminary view is that, for the vast majority of registered CAM charities, no action will be needed, either because the efficacy of the relevant treatment has already been established under our previous approach, or because it is clear that benefit can be demonstrated under the current approach.

So if the previous approach was in any way lacking (obviously, otherwise why have a new approach?), this doesn’t matter? All charities have to do is to launder what they put on their registration:

In some cases, it may be that we recommend that a registered CAM charity amend its objects, so that they are limited to what can clearly be demonstrated by the available evidence.

Surely what matters is what the charity does rather than what it tells the Charity Commission?

It is well worth carefully reading the Commission’s Legal Framework on CAM charities. For example, faith healing is not a permitted public benefit:

The courts have recognised some purposes relating to the promotion of faith healing as charitable. The Commission does not consider that these cases provide a legal basis for accepting purposes which include the advancement of faith healing (or any other form of therapy) otherwise than as purposes for the advancement of religion. This is because, on the modern understanding of the public benefit requirement, the analysis applied in these cases would not be sufficient to establish that a health benefit has been demonstrated.

There are about 250 charities that have been registered with `healing’ in their titles. Why? They do not comply with the law. The Framework also has useful discussion of the placebo effect, with emphasis on the balance between benefit and harm. The Commission understands that the placebo effect depends on the patient’s misunderstanding of the health condition and the `treatment’, and that this may affect the benefit to risk balance.

The Framework ends with an unfortunate and artificial division between complementary and alternative therapies. In practice these are not easily separated, and practitioners rarely state to which group they subscribe. It is fertile ground for the `bait and switch’ tactic.

But it is as I have said clear that the operational guidance (OG304) is what governs the enforcement of the Act, and this contains rather less wriggle room. I’ll just pick out some significant points, rather than exhaustively analyse the guidance. The foundation stone is laid in the second paragraph:

Public benefit is based on evidence.

Yet four lines later we have:

Benefit may arise, for example in palliative relief, even where scientific efficacy of a medical effect has not been established.

So does this require evidence or not? Or is such evidence unscientific but still OK? Confused? Join the club. This is just within the overview section, so hopefully things will be clearer in the main body:

Section 1 expands on the differentiation between complementary and alternative. I have already highlighted the difficulties surrounding this, and CAM charities are warned here that:

….where a method is intended to be used as a complementary method we would expect an organisation to use it for this purpose and not as an alternative to conventional medicine. If this was found to be the case in respect of an existing registered charity then further regulatory assessment and action may be needed.

Note that this refers to what the charity does rather than what it says it does. Any charity which suggests an unproven `alternative’ to evidence based treatment is vulnerable to this rule. A good example is the Vaccine Awareness Network, a charity which is virulently anti-vaccination and recommends homeopathy instead. This is a very clear breach of the Act.

The guidance defines the terms “therapy” and “palliative”, but again in practice the differentiation will be difficult. Under “therapy” is the term “alleviate”, but how is this separate from “palliative”?

Section 2 sets out the difference between charitable purpose and public benefit. I am a bit puzzled that to demonstrate the latter “evidence (where necessary)” will be required. I can only surmise that evidence will not be necessary if no claims are made.

The guidance quite rightly again considers the potential for harm, and I revisit the matter of CEASE therapy. Harm is a central part of this practice, as effects such as persistent diarrhoea are welcomed as part of the treatment. Charities will need to ensure that they are not encouraging such abuse, even unwittingly.

Section 3 seems at odds with earlier statements about where evidence is required:

In considering the claimed benefit it is necessary to consider specifically whether the claimed benefit relates to a specific illness or symptoms or is claimed to provide a generic benefit in respect of suffering and if so how. In either case evidence will be required to establish the benefit (my emphasis).

Previously we had evidence on an “if required” basis, but now it seems it is always required. This confusion needs cleaning up. The categories of effect – curative, diagnostic, and palliative – are perfectly reasonable.

I don’t have much to say about section 4, which covers charitable purposes. It strikes me though that “the advancement of education” might be problematical if what is being taught is nonsense. How could knowledge about homeopathy for example be a public benefit?

Section 5 covers evidence of benefit in commendable detail. I don’t think it is unreasonable to say that “benefit may be sufficiently obvious that it is not necessary to require further evidence”. Scientific tests are only required when the expected outcome is in doubt, and the classical example is splinting broken limbs. It is extremely important that the guidance firmly places the burden of proof on the applicant. Some regulators, such as Trading Standards, take the opposite view, which is wrong. Under sources of evidence (section 5.2) I am a bit doubtful about citing the US  National Center for Complementary and Integrative Health, which has for years been largely an apologist for CAM. I am even more at a loss as to why the guidance would refer readers to the The Complementary and Natural Healthcare Council, which is not remotely interested in asking registrants for evidence.

The Commission has clearly taken expert advice about types of evidence and their weight. If this guidance is followed, case workers will need quite extensive training. For years the Commission has persistently told me that they are not medical experts and not in a position to judge whether a claim is valid. Of course they are not, but perhaps the penny has dropped, We now have the pretty momentous statement that:

In some cases it may be necessary to seek an independent expert review of the evidence.

One hopes that experts will be carefully chosen. We would not want the situation that prevails with quack “medical journals”, where the peer reviewers are other quacks. Most of the time it won’t be necessary, as there are copious amounts of authoritative guidance, such as The Desktop Guide to Complementary and Alternative Medicine by Edzard Ernst.

Section 5.6 is generally well written. A distinction is again drawn between overt claims to cure a disease, or to improve clearly measurable parameters, and vague effects on wellbeing. It’s good to see the word “robust” used in relation to evidence. This to me means properly designed and conducted trials, but I’m not sure whether that is what the writer meant. At least patient testimonials are ruled out. Patient Reported Outcome Measures (PROMs), discussed in a bit of detail, are a completely different thing, and HealthWatch has clarified this point in a response to a BMJ editorial.

It’s interesting to see that mechanism of action can be taken into account when evidence of efficacy is doubtful (section 5.7). As by definition all CAM is based on imaginary mechanisms, some fascinating challenges might be on the cards.

The arguments in section 6.0 have largely been carried over from the old guidance, and perpetuate mostly similar dangers. It depends on what is meant by “consensus”. In a scientific sense it means agreement by a majority of authoritative scientists, and that would be OK. No point in reading all the original research again if knowledgeable people have already done that and agreed what it means. The danger is that it might be confused with noise level and “argumentum ad populum”. I’m not happy with the use of chiropractic and osteopathy as examples of therapies already accepted as effective. These practitioners commonly make wild claims way outside the relatively weak evidence for the core indication of low back pain.

The discussion of potential harm in section 7.0 is pretty good. CAM supporters bang on about how it’s always free of side effects, but (a) that’s not at all true, and (b) the Commission fully understands the harm from eschewing treatment that works. I note that in this section, and earlier, reference is made to what applicants have to demonstrate. This is what the Commission will ask anyone wanting to register a new CAM charity.

What happens to the many already registered, and who wilfully mislead the public? This should be explained in section 8.0 (Regulation), but isn’t. It is highly misleading to claim that the Professional Standards Authority and the Complementary and Natural Healthcare Council are anywhere near being effective regulators. Neither asks any registrant for evidence of effective treatment. Evidence based practice is not mentioned either within the standards of the Health and Care Professions Council.

Overall, the new guidance is an important step forward. The previous guidance was not all bad, but the Charity Commission steadfastly resisted applying it when complaints were made. Now that a public commitment has been made as a result of a valid legal challenge, the Commission is on notice to start acting as a real regulator. Government would be well advised to resource the Commission to enable that to happen.

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