Wednesday, 18 April 2018

Suggestions on Naturopaty/Homeopathy in Canada

This is a very different post from the majority of the post on this blog. There is heightened concern about the activities of naturopaths in Canada. Naturopathy often includes the use of homeopathy - which explains the interest - as does some of them offering CEASE therapy. This blog post outlines some legal and regulatory aspects regarding naturopathy and practical steps that those concerned could take.

Some of steps are tactical and fairly immediate, some are more strategic and likely take a lot of time and effort to enact.

It is not intended to look too deeply at the regulation of homeopathic medicines. A future post will do this. Some understanding of the regulation of naturopathy and some other legislation is necessary before discussing potential actions.

What applies to naturopathy also applies to chiropractic.

Regulatory Framework

Six Canadian provinces license naturopathic doctors: Ontario, British Columbia, Manitoba, Saskatchewan, Alberta and Nova Soctia. Ontario also licenses homeopaths. They fall into two groups - laws that explicitly recognise naturopathy/homeopathy and those that enable the recognition of naturopathy/homeopathy. Some details will be glossed over.

The laws are -
Saskatchewan is problematic to deal with and will be ignored for now. Nova Scotia's legislation is minimal to say the least and again will be ignored. The various Acts will be referred to as HPA.

With the exception of Quebec, the Provinces/Territories that do not recognise naturopathy have low populations. In these provinces, naturopaths enjoy no special status other than as an ordinary citizen under common law. Their ability to prescribe certain medicines and perform certain procedures is that a member of the public.

Quebec is a civil law jurisdiction. Under such jurisdictions there is no "common law" right to "practice" medicine. Quebec has professional orders - each of which have their own remit and protected title. It would seem that naturopathy is tolerated to a degree in Quebec but naturopaths are often conducting activities that are reserved for professional orders. Illegal practice of medicine is dealt with by the Collège des médecins du Québec Inquiries Division. In essence, the practice of naturopathy by anyone other than a medical doctor is illegal and there have been convictions. Many naturopaths have left Quebec for Provinces that recognise Naturopathy or maintain registration there. Some patients travel to Ontario for treatment.

Naturopaths in Provinces/Territories where naturopathy is not recognised are campaigning for recognition. There is an opportunity for campaigners/activists to act before this happens.

Initial Application
Professions which wish to be recognised generally have to apply for recognition to the Provincial Minister of Health (although the Minister does have the power to consider the need for regulation without the need for application). The form that the application takes and the fees vary. Professions that seek recognition generally already have some form of organisation (tend to be called "colleges") but there may be more than one - consolidation would be required.

The Minister has the power to reject applications at this stage, if not rejected the application is passed to an Advisory Board, although the Minister does have the power to grant recognition without this step (but this could be subject to legal challenge).

However, some Provinces had pre-existing - now repealed - legislation regarding naturopathy. It is unclear if applications were actually made or previous legislation simply re-written. Nonetheless, the same kind of decision making process should have gone on. Simply transposing existing legislation into new legislation should never happen. Firstly, there would be little point in doing so and secondly, even minor amendments should require scrutiny as there can be unintended consequences.

Advisory Board
The composition of the Advisory Board may vary by Province as may whether they are permanent or temporarily recruited. The role of the Advisory Board is to advise the Minister - they make recommendations, they have no decision making powers themselves. Their basic duty is to determine whether a profession should be recognised. 

Factors that they may take into account include whether the "profession" is actually a profession (as opposed to say - a group of persons who claim to be of profession X but actually practice many disparate therapies - or not really a health profession at all), level of qualifications of the profession, the level of risk posed by the profession, the ability of the profession to regulate itself. There doesn't seem to be any emphasis on considering efficacy (beyond whether a profession is actually a healthcare profession), just (relative) safety.

Their powers vary but they can have the power to request information, hold hearings and so forth. In addition to recommending whether a profession be recognised, they can also make recommendations regarding the scope of practice - in other words what medical procedures are permitted/forbidden. Essentially, the scope of practice is a list of what are described as controlled acts under the HPA.

The recommendations will be provided to the Minister who will make the decision to recognise of not.

The recognised Colleges are -
Recognition gives colleges a number of powers and also imposes certain duties. The HPA also specifies how Colleges are structured in terms of Councils (governing body) and committees. It also specifies the make up of these bodies and who appoints them.

Most of the detail is dull and not particularly relevant.

Councils have the power to make bylaws. Bylaws relate to how the College functions and to a degree how members conduct themselves. 

Duties vary. One key duty is to provide the Minster of Health with an annual report. These annual reports, if not already in the public domain, should also be obtainable by FIPPA. What these annual reports must contain varies. Some Councils will produce reports that go beyond the mandatory minimum - after all, although not exactly a marketing tool, they can have an effect on public confidence. 

Reconsideration of Recognition etc
Some Provinces' laws could be read in such a way as indicating that once a profession is recognised, once a college is establised, end of story. Whilst a Minister may have the powers to remove College council members etc, they do not have the explicit power to remove recognition. If a College is failing to effectively regulate members, that might make sense, but if it becomes apparent that self-regulation simply isn't possible?

(Members who don't want to abide by regulation can always leave or be expelled. Some professions, such as Chiropractic are deeply divided - under regulatory pressure, it could fragment. Chiropractic has also spawned a number of off shoots that often see themselves as separate professions. Loss of members can have profound financial implications for a College.)

Also, in these cases, there appears to be no way to vary the scope of practice of a profession. This effectively prevents the prohibition of, say, a particular treatment that is new evidence suggests to be ineffective and dangerous. It could also prevent the adoption of novel new treatments treatments - although this is less likely as the scope of practice of naturopathy is very ill defined.

Ontario's law does have a provision that allows for reconsideration of recognition. 

Of course, making changes to scope of practice via reconsideration by an Advisory Board is cumbersome compared to simply changing the bylaws of a College - although this could only achieve further restriction on practice.

Scope of Practice
What naturopaths are permitted to do varies considerably. Arguably, British Columbia has the most lax, Ontario the most restrictive.

It is worth pointing out that historically, naturopathy often saw itself as "drugless medicine". It used therapies such as hydrotherapy, herbal medicine, homeopathy and eliminating overeating, tea, coffee and alcohol. Vitalistic beliefs were (and still seem to be amongst some) key. Benedict Lust is considered the Father of US (and by extension Canadian) naturopathy. Over time, some naturopaths have expanded way beyond this (although a few stick more closely to the original practice - with the addition of supplements). It is a trend that some wish to continue. At one point Ontario had a Drugless Practitioners Act.

The Regulated Health Professions Act contains a list of controlled actsOntario naturopathic Scope of Practice can be found in the Naturopathy Act linked to above. More detailed information can be found in Ontario Regulation 168/15. This is a long document. It lists which of the controlled acts are allowed for naturopaths.

It places limits on internal examinations. It places limits on drugs that can be injected/inhaled. Chelation would appear to be forbidden, from the list of drugs that can be prescribed. The number of drugs that can be prescribed/compounded/dispensed/sold is very limited. There are also limits placed on spinal manipulation including a long list of contraindicated conditions. It also mentions the limited number of blood tests that are permitted. No specific mention is made of hyperbaric therapy or ozone therapy - presumably they are forbidden. Certain controlled acts require additional qualifications. 

What is interesting that the Regulation places makes it mandatory to refer clients to physicians (ie real doctors), extended practice nurses and other registered health professions when i) client is in imminent danger ii) beyond the scope of naturopathy (which is not defined in clear terms iii) diagnostics are required unavailible to naturopaths and iv) if client (or their representatives request it).

British Columbia's Naturopathic Physicians Regulation is much more permissive. It allows chelation, it allows ozone therapy. It allows a much wider range of spinal manipulation and has no contraindicated  It even allows minor surgery. It allows much wider prescribing (including Tramadol!), ordering of tests, use of equipment (including fetal ultrasound imaging). Most worryingly, there is no mandatory requirement for referral. Essentially, it allows BC naturopaths to treat any disease.

Code of Ethics et al
There is a hierarchy of HPA, regulations, bylaws and then it gets a bit murky beyond that. Codes of Ethics exist, and notionally members of a College are supposedly contractually bound by those but considerable leeway is granted to disciplinary committees to intrepret. Below exist "guidance" and "best practice" - there is an expectation that certain things should be done and that there is a right way to do them but there is no means of enforcement. Of course, if a member of a College finds themselves in front of a disciplinary committee, it may or may not be taken into account.

As previously mentioned Bylaws relate mainly to the internal functioning of a College. 

Codes of Ethics vary. The Ontario one can be found here. The British Columbia one here. They tend to deal very much in generalities but both example cite the need to comply with legislation and regulations. They also both cite human rights - which obviously includes the rights of children and the disabled.

Other Legal and Similar Matters

Freedom of Information
Each Province has its own Freedom of Information legislation -

Acronyms may vary but FIPPA will be used. Whilst FIPPA does not extend to the Colleges themselves, it will cover correspondance between the Colleges and Federal and Provincial Government and their agencies. The are exemptions - Provinces may refuse to disclose on certain grounds but there is a right of appeal and a legal escalation route.

Child Protection
Each Province has its own Child Protection laws. They may vary in wording but not in intent. To quote from the Alberta Child, Youth and Family Enhancement Act -
(2.1)  For the purposes of subsection (2)(c), a child is neglected if the guardian
                           (a)    is unable or unwilling to provide the child with the necessities of life,
                           (b)    is unable or unwilling to obtain for the child, or to permit the child to receive, essential medical, surgical or other remedial treatment that is necessary for the health or well‑being of the child, or
 (c)    is unable or unwilling to provide the child with adequate care or supervision.

Certainly in Provinces where naturopathy is not recognised, reliance by parents on naturopathy as primary care would be considered neglect - naturopathy is not medical treatment. In those Provinces where it is recognised, the test would be "essential" treatment.

It is important to note that the law generally places the burden of liability on the parent(s)/guardians of a child. A naturopath would not be necessarily held liable for giving poor advice that resulted in harm although they would be if a prescribed drug or treatment did. That would be dealt with under separate legislation/regulations - medical negligence and there are lawyers who specialise in this.

Disability Rights
Where this really matters in the case of those unable to give consent due to mental incapacity. It is much the same as with Child Protection. Typically, this involves learning disabled adults and elderly with dementia.

Aboriginal Rights
Aboriginal healers/midwices are generally exempt from HPA etc. This does not mean that a naturopath who is an an aboriginal would be exempt - the use of the title "Naturopathic Doctor" would override that. 

Advertising Regulation
Canada does have a voluntary advertising regulator - Ad Standards. It has an Advertising Code and also publishes various guidance. The Code is not as highly specific as those of some European advertising regulators but it has made several key rulings against complementary and alternatively medicine provides under Clause 1 and Clause 8 of the Code.

The Code is essentially an understanding of consumer protection legislation. Like the US, consumer protection is a mix of Provincial/Federal legislation/agencies. The most important piece of legislation is the Federal Competition Act which is enforced by the Competition Bureau. The section of interest is PART VII.1 - Deceptive Marketing Practices - Europeans will be surprised at how sparse it it. The Competition Bureau has extensive powers though.

Specific Actions
The variations in the Codes etc of the Colleges and the differences between Provinces' laws make it difficult to be specific. 

Legal Challenges to Ministerial Decisions
The deliberations of the Advisory Board and the reasoning of the Minister in granting recognition should be available via FIPPA. 

One key question about the recognition of naturopathy/homeopathy would be whether (i) the Advisory Board carried out sufficient risk assessment, etc, of the profession and the therapies employed and (ii) if so, did the Minister fulfill their duty to public health in light of those recommendations? Another question would be whether a College misrepresented the nature of the profession and the therapies involved.

Scope of practice is likely more important. In the case of naturopathy, it is known unsupervised (by a real doctor) chelation is permitted (at least in some provinces) as well as ozone therapy. It is also known that some naturopaths practice CEASE therapy (see here for a UK perspective). Naturopaths are notorious for ordering all manner of expensive tests that often have little or no practical value. Some use bogus "diagnostic" machines.

Comparisons with other jurisdictions not granting recognition or imposing limits on scope of practice would be useful, especially if the deliberations involved could be gained by FIPPA type requests. Safety reviews, medical authorities (eg US FDA, UK NICE) rulings/guidance on individual therapies may also be helpful. 

Demonstrating evidence direct harm caused by a Minister's decision to grant recognition and/or not place appropriate limits on scope of practice is tricky. All procedures carry risk - the question is whether or not the potential benfits outweigh the risks in an overall context. If the Minister chose to ignore recommendation of the Advisory Board, and direct harm had then occurred, that would be much more clear cut.

Identifying potential risks and harms is relatively simple. However, the likelihood of such risks/harms is difficult to estimate. Legislating for the almost never might be considered over-kill.

In theory, petition (application) for Judicial Review of such decisions is possible on such grounds. It depends on the rules of the Provincial Court and/or associated legislation whether there is any time limit on petition for Judicial Review. For example in Alberta, the limit is 6 months. In British Columbia there is no limit. In any case, any future decisions to grant recognition etc of other professions or in different Provinces could be challenged.

Whether a Court would overturn the recognition of a College is unknown. An order for the College to re-apply, the Advisory Board to consider evidence and make new recommendations and the Minister to make a fresh decision. It may be the view of the Court that the other remedies (which will be discussed).

Application for Judicial Review requires the services of public law lawyers. This will require funding - crowd funding is an obvious solution. In terms of who makes the application, it would have to be a group with "standing". Preferably it would be someone who was adversely affected by recognition or the scope of practice of a College. Representative groups who represent potentially affected persons would have standing as likely would medical associations (they represent not just themselves - they also have a duty to public health).

The Colleges may be become involved if Judicial Review goes ahead - or even at the application stage. However, their involvement is likely to be limited. Judicial Review is not a normal court of law - it is mostly concerned about the decision made. The Court are unlikely to consider the efficacy of therapies offered by naturopaths - indeed it may well accept as fact that the overwhelming scientific and medical consensus is that most of the therapies have no efficacy beyond placebo.

It is not necessary to garner public support for this, except for funding.

Amendments could be made to HPA to include additional factors that include child protection, a greater emphasis on public health (including vaccination) in the deliberations of the Advisory Panel. 

Where no powers exists to review the recognition and Scope of Practice, they could be introduced.

Consideration of Scope of Practice could be expanded from just what is permitted in the way of medicines prescribed and procedures to include conditions and vulnerable groups. The Swedish Patientsäkerhetslag (Patient Safety Act) prevents non-medically qualified from treating certain diseases such as cancer and also vulnerable groups such as children and pregnant women - a criminal offence. Other Nordic countries such as Norway have laws like the Lov om alternativ behandling av sykdom mv (Law on Alternative Treatment etc) that place criminal liability on practitioners if a patient does not seek appropriate treatment as a result of their advice. It also does not permit ignorance as a defence if a patient is put at risk. Mandatory referral is an absolute must.

The duties on Colleges could be enhanced - partly to include considerations regarding child protection, public health and so on. A key enhancement would be to increase the amount of information in annual reports as well as other information that must be placed in the public domain. Adverse incident, complaint, etc reporting are important.

It would be difficult to argue against amendments to Provinces' laws that allowed periodic review scope of practice, recognition, etc. Such amendments would add to protection of the public. The only real argument against this is that it creates more bureacracy and an administrative burden. This could be mitigated in part by having different intervals between reviews for different professions - likely driven by scope of practice and the level of risk posed. It could also be mitigated by not so much set timetables for review but by setting criteria that trigger review. For example, increase in number of complaints received, adverse incidents, etc but setting such criteria could create an incentives for Colleges to suppress complaints.

Arguably, a permanent Advisory Board could fill that oversight role and it would look after all regulated professions including Doctors, Nurses, Dentists and so on. This is a very compelling argument. It really is about patient safety not just picking on Naturopaths. It seems very unlikely that the Colleges of actual medical professions would object to this - indeed, they may well be highly supportive and wish to be engaged.

Whilst there is no specific need for harmonisation of HPA, greater harmonisation would reduce the frequency of practitioners/patients moving between Provinces to practice/seek treatment. It could also be argued that could increase the mobility of labour.

This is likely to involve a lot of campaigning. There needs to a display of grassroots support for amendments to the law. "Skeptics" often lack the experience of effective campaigning nor are they particularly well organised. Patient advocacy groups and medical associations generally have more experience and are better organised. Effective campaigning costs money ultimately, but a lot can be done for very little - many people will give up their time for free. A large proportion of the public will be sympathetic to the issues but they are unlikely to be aware of them - raising awareness is key. Public support can be demonstrated in all sorts of ways - petitions, sending letters to politicians (although this can be counter-productive) and other potential individuals/groups who have influence on politicians and even public opinion surveys. However, it is important to have a consistent, factually correct and concise message. One observation of "quack" groups (especially homeopathic supporters) is that their campaigning is ineffective because it is often factually incorrect and indulges in whataboutery and paranoid conspiracy theories. "Big Pharma", doctors, critics of homeopathy are all part of an evil conspiracy. They often involve "rights" that simply do not exist in law.

Creating that message is key. The message needs to be seen as coming from a number of different groups in order to protect and enhance public health. It needs to be seen as protecting, especially vulnerable groups, not seeking to inhibit naturopathy simply because the authors of the message don't like it. Health and science educators with experience of successfully delivering messages to the public will need to be involved. Patient etc advocacy groups will need to be involved. The medical professions will also need to be involved.

Involving the media is also important although with the advent of social media, less so. At times someone with a large following can reach more people than conventional media. It can be dificult to get the media interested, 

It's not necessary to state what specific amendments are required to each Province's HPA should be. What needs to be done is create a "best practice" model of what the HPA should look like, what the role of the Advisory Board should be and so forth. Experience in drafting legislation would be useful but not essential.

Finding politicians who would be sympathetic to amending HPAs should not be too difficult. They will be the ones who will push through amendments to legislation. Patient etc advocacy groups will know who they are.

It is worth pointing that the Colleges will likely mount their own campaign to counter any amendments, especially the BC College. Their livelihoods are at stake. Naturopathy can be lucrative and potentially any campaign could be well-funded (but the Colleges themselves might not be). The Colleges may be able to call on support from other groups such as the "health freedom" movement - some organisations are well funded and organised. Some are essentially run by lawyers who make money from challenging public health protection laws. Supplement and alternative medicine manufacturers may offer financial support. There is also a considerable pool of disorganised anti-vaccinationists and "natural medicine" enthusiasts to call upon, not just in Canada but in the US too.

Consideration will need to to given as to what tactics the Colleges and their allies may employ. Lessons need to be learned from the campaigns that the Colleges may have mounted in order to gain recognition, campaigns that health freedom groups have mounted on issues such as mandatory vaccination, fluoridation and removing restrictions on the supplement market. There are likely to be some politicians who will be sympathetic to their campaign - but likely on the grounds of a free-market, anti-regulation, consumer "choice" stance rather than a special liking for naturopathy. It is very likely that any campaign will be couched in terms of portraying what is essentially a drive for greater consumer/public health protection as an "attack". 

There is an argument that naturopathy exists and that no legislation can make it disappear. The argument goes on to state that it is better to have sort of regulation than none at all. This ignores the fact that laws exist that prevent ordinary members of the public prescribing medicines, performing certain procedures and so on. 

Changes to College Codes etc
Convincing Colleges to change bylaws, Code of Ethics, etc likely to be difficult. If they took duties to public health, child protection and so on seriously, they would have done so already. It would be much quicker that amending legislation.

The kind of pressure - political, social and medical - that would need to be applied is enormous. Possibly greater than getting legislation amended and it would be political pressure that would be most effective. There has been some talk of reviews of self-regulation but they do not seem to have materialised. The value of such reviews are moot unless they concern themselves primarily with changes to legislation. The threat of changes to legislation might convince some Colleges to voluntarily change codes bylaws, codes, guidance etc but other Colleges might possibly passively/actively resist any pressures.

It's very much the same story as with campaigning for changes to legislation but with the additional twist that voluntary change could be presented in such as a way as a College acting responsibly. But such changes can be merely lip service. Without the will to enforce those changes, nothing really has change. Colleges would very likely lose members. They might face legal challenges from members that they discipline. The financial status of individual Colleges is unknown but some of them could face real difficulties.

Ignoring pressure? Naturopathy has a strong element of ignoring evidence that is contrary to its beliefs as well as a casual disregard for legislation and regulation. 

Complaining to the Colleges
Some say that this is pointless given the history of the Colleges' indifference to previous complaints. 

However, the UK experience is somewhat different. What happened to the UK chiropractic regulator, the General Chiropractic Council (GCC), as a result of British Chiropractic Association (BCA - a trade association - one of several) libel action against Simon Singh (over this article) is instructive. This Guardian article documents how the libel action started to backfire. Alan Henness and others made complaints to the GCC about BCA members. The numbers are astonishing. The effect on the GCC was dramatic to say the least. No regulator is equipped to deal with this number of complaints. The GCC had to employ more staff to deal with the number. The GCC's Annual Report for 2010 gives an idea of that impact. To it's credit, the GCC did take the complaints seriously - it has a legal duty to do so and also regulatory oversight by what is now the Professional Standards Agency. The GCC were never in any serious financial trouble but not every regulator is.

One thing that is clear is that the Colleges have a default position of "it's in the scope of practice" when concerns are raised about activities of members. Obviously this is not the most effective line of attack to take - even in British Columbia there is the lucidrous situation of naturopaths being permitted to treat any condition. 

Advertising is a definite weakness. Referring again to the case of the GCC, complaints were made on the basis of unsubstantiated claims. The Colleges do state that members must abide by legislation and this includes the Competition Act. It's important to realise it's not just the claims that are made for naturopathy that matter but also the claims against conventional medicine eg "vaccines cause autism". There is a presumption in HPA etc that Colleges are the first port of call for complaints. Making it known publically that complaints are being made can be effective, especially if the media pick up on it.

Complaints regarding unfair commercial practices such as "bait and switch" can also be effective. US chiropractors are notorious for these kind of practices - whether they have penetrated Canadian naturopathy is unknown.

Complaints based on child protection and the rights of the disabled are possible but likely tricky as legally because of issues of liability as previous discussed.

If there is a particular claim is common to many naturopaths, omnibus complaints can be made. As can be seen from the case of the UK GCC, these can be highly effective and have the potential to cause real problems for a College. Whether or not Canadian campaigners 

If a College doesn't deal effectively with complaints, this can create adverse publicity. Also, it's not the end of the road...

Complaining to Ad Standards
It isn't necessary to complain to Colleges first but it is likely Ad Standards would prefer that people do. Making mass complaints to Ad Standards is a possibility but flooding them with complaints would likely reduce their effectiveness.

What is likely to be more effective that mass complaints or omnibus complaints is making strategic complaints about single advertisers whose advertising contains one or more examplar problem claims. A ruling by Ad Standards on, say, a particular claim for a particular therapy could then be cited in complaints to colleges.

Ad Standards also allow complaints from Special Interest Groups. This is potentially very useful. For example, it's possible to imagine an association of Public Health professionals making a complaint about anti-vaccination propaganda in a naturopath's advertising. Likewise autism activist groups making complaints about claims for chelation, CEASE therapy, etc as treatment/cure for autism.

Ad Standards may also be amenable to issuing sector specific guidance. The UK Advertising Standards Authority (ASA) has done this for chiropractic and homeopathy.

Of course, Ad Standards is a voluntary regulator. If they rule against an individual naturopath, that should be enough for a College to act on but failing that complaining to the Competition Bureau is possible.

Complaining to Provincial Consumer Protection Agencies
It's very clear that these Agencies don't really want to deal with complaints about advertising. They are more concerned with unfair trading practices in certain business sectors. It's unlikely that they would be particularly interested in the healthcare sector as it mostly covered by HPA and the Colleges.

Complaining to Competition Bureau
The remit of the Competition Bureau does cover advertising. There are many remedies available to it. 

It has the powers to intiate prosecution. Although this Federal database doesn't turn up any particularly relevant rulings, there is an argument that a decisive Federal Court ruling on advertising of naturopathy would have dramatic effects. Even a Provinicial Court ruling would arguably set a precedent (although Quebec as a civil law jurisdiction less likely to take note).

Obviously, this can't cover everything. Comments are very much invited, especially questions. If people don't wish to comment on the blog and would rather ask questions directly, emails can be sent to ukhomeopathyregulation(at)

Friday, 13 April 2018

Homeopathic Treatment of Autism - Evidence #4

Forensic dissection of every UK lay homeopath's online utterances would be incredibly dull to read. A more thematic approach is taken.

Something that does appear in safeguarding guidelines is the issue of vaccination. A child not being up to date with vaccinations, or worse, never having been vaccinated at all is considered a potential sign of neglect. There is research to suggest that autistic children are at greater risk of neglect. Denying a child appropriate medical treatment is neglect.

It is not difficult to imagine an attitude that autistic children are some how of less value and thus less deserving treatment. Neglect due to this kind of indifference and is something that professionals should recognise.

Previous posts have highlighted that homeopaths who claim to treat autism are very anti-vaccination and along with that very against medical treatment. On the face of seeking homeopathic treatment does not look like neglect but it can be. Professionals unfamiliar with homeopathy and in particular treatments such CEASE therapy may not recognise it as such.

Sian Collister
Collister is a member of the Alliance of Registered Homeopaths (ARH). Collister's website home page offers "Homeopathy for Autism and Vaccine Injury Recovery". She offers CEASE therapy but also talks about Biodynamical Cranio-Sacral Therapy
I am a co-founder of Homeopaths Support Refugees, running day clinics in refugee camps in France and Greece and and supporting homeopathic projects in Kurdistan and Turkey since January 2016.
Additionally she has a sideline in Anthroposophy "inspired" wooden toys.

Collister doesn't say very much about autism or CEASE therapy but offering Skype consultations is concerning. How someone can guage the condition of a child who has potentially has communication difficulties without direct observation and examination is unclear. Offering Skype consultations to international clients is even more worrying. To begin with, there can be language issues. This notionally exists in many medical contexts which is why the NHS offers interpreters as well as publishing information in different languages. In a private setting, interpretation is rarely available and then often as an extra cost. Additionally, a practitioner may have no understanding of how to access other services in the client's locality. UK practitioners may not grasp that access to emergency services in some places can be difficult and or very expensive. And so on. To describe a UK homepath offering Skype consultation as telemedicine lends it too much credence but some of the same legal and ethical concerns do apply. 

However, in the context of CEASE therapy, it could be argued that no real consultation is needed as much of it consists of giving ineffective homeopathic remedies blindly in response to a history of "toxic exposures". This could be done in other ways without the need for an expensive consultation.

Collister has a blog. It has a post about homeopathic detox "reversing" autism. It is not impressive and worrying that the child had been subjected to hyperbaric therapy amongst other things. It mentions that "detox" of steroids was conducted first and then a "Childhood Poly Vaccination detox" which was repeated several times. So, instead of systematically (ahem) dealing with levels of "toxification" as per Smits, Collister treats for all possible ones. This was seen in the previous post with Anna Rayner.

There is another post about "treatment" of an autistic child. What Collister fails to point out is that there were obviously concerns on the part of doctors about maternal exposure to Tuberculosis. BCG vaccination is rarely given in the UK. Likewise with Hepatisis B and vaccination. Too little information is given to make conclusions but very worryingly -
I started Andrew’s treatment with a Bowel Nosode and Tuberculinum and followed this with a Poly Vaccination Homeopathic Detox. Organ support remedies were also prescribed to support the paths of elimination. Andrew was also seeing a nutritionist who had prescribed some supplements as support.
Tuberculinum is a "nosode" - what is made of seems to vary by manufacturer - some say made from TB bacteria but mostly likely from the sputum from someone with TB. Some homeopaths use it as homeoprophylaxis or treatment for TB but it is used for other purpose.
Andrew had a fever several times during the detox, after each fever he seemed slightly better – gained a word, wasn’t as hyper and easily angered. His diet was still limited and his desire for indigestible things continued.
Then worse.
It has been amazing to observe Andrew improve. His parents have trusted his body’s healing ability and allowed him to have fevers without suppressing them. Homeopathy has been gentle yet powerful for this young child.
The blog is difficult to navigate. Collister's website is likely not configured correctly. There are more posts claiming improvement in cases of autism but thankfully, they are likely difficult for the public to access unless they stumble across them via internet search.

Collister is an "advocate for informed consent and co-ordinate the Arnica East Herts Parent Support Network." Put another way, she is part of an organisation that is virulently anti-vaccination and a threat to public health. The Arnica Group disseminates all kinds of bogus information - it is not concerned with "vaccine safety". 

Jennifer Hautman
Hautman is a member of the Society of Homeopaths (SoH) styling herself as "The Essential Homeopath". 
My aim is to empower and teach you to be your own family physician -
to provide you with all the tools you need (including homeopathy and essential oils) and the confidence to use them. 
My mission is to create healers in as many homes as I can.

As discussed in a previous post, Hautman has issues with the Advertising Standards Authority (ASA) but has no issues with groups run by ScientologistsHautman is also a doula - a non-medical person who helps after the birth of a child, although some will attend birth. Hautman clearly offers this. Hautman is not a member of Doula UK - a voluntary organisation that . Hautman does not state what, if any, training she has had. One thing that is clear is that doulas do not offer medical treatment or advice. Hautman does this in spades as well as attempting to sell all sorts of products to her (potential) clients. Other doulas might find this unethical.

Although the law has been relaxed to allow anyone to attend birth, putting aside competence issues, there are possible implications for liability insurance. Specialist doula insurance does exist, but it would not cover use of therapies. Membership of the SoH requires liability insurance but it would not necessarily cover doula actitivies.

Hautman is a victim of an American multi-level marketing (MLM) scheme. Involvement with doTERRA essential oils does suggest a level of credulity and/or desperation. Most of those involved in MLM schemes fail to make any money. The products are vastly over priced. The importation of these products is legally dubious. doTERRA have been the subject of an FDA warning letter. In the US there are concerns regarding marketing of the products aimed at the parents of autistic children. Hautman offers "training" in the use of essential oils that she charges for. Hautman actively encourages people to sign up for the doTERRA scam.
Although I do not recommend it, you can purchase doTERRA oils retail through me. I highly encourage you to get your own doTERRA wholesale account to save 25% on all product purchases, but if you prefer you can purchase retial here.
Hautman offers "training" in fever. Information on how to treat fever and when to call for medical help is freely available as here on the NHS Choices website. The page links to a dubious paper that speculates autism may be due to suppressing fever (no evidence is provided) but Hautman believes this is proof!
Standard medical guidelines state that fever medicines (anti-pyretics) should not be used to try to reduce a temperature, as this has been found to prolong the duration of the illness, worsen the illness, and lead to an increased risk of allergies, asthma, eczema and autism.
The NHS Choices website actually says "give them paracetamol or ibuprofen if they're distressed or unwell." It also says not to "undress your child or sponge them down to cool them – this doesn't help reduce fever" which is often recommended.
At the end of it all, my aim is to teach you, in a very short amount of time, how to raise happier and healthier children, which will save you from future sick days off work & school, saving you more time & money to spend with your family, and, I hope, saving you from a lot of worry.

So the question is: Can you afford not to buy this course?

Her page on treatment of autism mentions that she practices CEASE therapy. It is deeply anti-vaccination - unsurprising given links for Arnica Group events etc found elsewhere on the website. Involvement with the Arnica Group is problematic for SoH members given that the SoH's stated position on vaccination (which is no longer visible to the public). The page contains a link to the now defunct Foresight Preconception - a spectacularly bogus "charity" whose dodgy hair analysis and vastly over priced supplements were much liked by some homeopaths. There is a link to the seemingly now defunct The Autism Clinic discussed in this article - it offered chelation, hyperbaric therapy and all sorts of dodgy tests. There are plenty of other links to anti-vaccination and bogus therapy websites.

Nowhere does Hautman state whether she has actually treated any autistic children. No mention is made of any "successes" and so on.

Thursday, 12 April 2018

NHS Homeopathy #5 - Update of British Homeopathic Association's Judicial Review Application

The British Homeopathy Association (BHA) now have a date for the Judicial Review and have launched a second crowd funding campaign. A statement on their website says -
We are launching the second part of our campaign to help fund the legal fees for our judicial review hearing which has been set for 1 May. Your support will help make NHS England more accountable, defend patient choice and, more importantly, ensure patients have genuine input on their access to cost-effective healthcare they use and need – in this case HOMEOPATHY!
That part of the statement is somewhat misleading. 

For one thing, as a previous post made very clear, there are not that many GP surgeries that that routinely prescribe homeopathic medicines and the majority of GPs that do so would seem to offer Anthroposophic medicine and likely are responsible for the majority of prescribing of herbal medicines as well. Anthoposophic medicine is viewed by its adherents as different from homeopathy and is steeped in esotericism in a way that homeopathy practiced by the likes members of the Faculty of Homeopathy generally isn't. Whether patients of these GPs or supporters of the BHA realise they are essentially supporting mystical doctors with very strange ideas is unknown but seems very unlikely. A discussion of Anthroposophic medicine is beyond the scope of this post but it has very strange ideas about diseases being essential to the "spiritual development" of children and advocates against vaccination and is implicated in various measles outbreaks.

The statement contains a link to the second crowd funding campaign which only near the very bottom states -
We have been granted a 'rolled up' hearing where the grounds for permission to bring the judicial review and the case will be heard at one time. This will be May 1-3, 2018 in the Administrative Court at the Royal Courts of Justice in London.
This is incorrect. The presiding judge will consider in camera the written application of the BHA's solicitors along with written submissions from NHS England's solicitors.The hearing can commence immediately if the judge accepts the application. It might be assumed that a "rolled up" hearing is only granted on the basis that the application is likely to succeed. They can be granted on the basis of urgency, complexity and also cost. If permission is granted, an immediate hearing after would potentially save costs but if permission is not granted then solicitors have done a lot of work in vain and barristers have been retained for no purpose.

Is permission likely to be granted?
It is difficult to say. Many potential applications for judicial review end up falling by the wayside before a judge even looks at the submission. Solicitors will advice clients that they simply do not have a case. It is unknown what exact advice the BHA would have been given but their solicitors should have told them that the majority of submissions are rejected.

The grounds on which application for judicial review discussed to some degree in this post. It raised the issue of "standing" but did not go into much detail - it assumed that readers would follow the links etc. It merits greater discussion. Much as it may annoy some, not just anyone can apply for judicial review simply because they disagree with the decision of a public body. Those that are considered to have "standing" are persons directly affected by the decision (or lack of decision). In English law, "person" has a broader meaning than individual human being - there is the concept of the "legal person" that applies to organisations. Trade unions have made applications representing their members. Groups that protect or campaign for certain public interests have been granted applications as well. Amnesty International have for example.

But does the BHA have "standing"? The BHA is both a registered charity and limited company (the latter is not unusual for charities and does not signify anything in itself). The BHA's stated "mission" from their website is -
To build greater awareness of homeopathy as an effective health care choice by the public through:

• promoting the value of homeopathy and its practice by statutorily regulated health professionals;
• promoting the advancement of the study of and training in homeopathy;
• research into homeopathy that will make an impact.
The BHA is not a membership organisation. Neither patients or doctors can join. Historically there seems to have been something called the "Friends of the BHA" but this seems to have disappeared and instead supporters can subscribe to a magazine. Thus it represents no-one, per se, more the abstract concept of homeopathy as healthcare.

Doctors who practice homeopathy have their own organisation - the Faculty of Homeopathy (FoH) - and the BHA exists mostly to promote them and fund their "training". The FoH would have definitely have standing to request judicial review were it not for the fact that those prescribing homeopathic medicines on the NHS are Anthroposophists, not medical homeopaths. Anthroposophists have their own voluntary regulator - the Council for Anthroposophic Health and Social Care (CAHCS) - and there is also the Anthroposophic Health, Education & Social Care Movement (AHaCS). Either of these groups might be regarded as having standing in terms of representing Anthoposophic GPs. Curiously, no Anthroposophic group seems to be bothered by the Consultation. 

There do not seem to be any formal homeopathic patient groups. Yes, groups like the Friends of the Royal London Hospital for Integrated Medicine exist but its scope is very limited. Individual patients of Anthroposophic GPs could in theory have standing but the picture painted of such patients by the BHA is that they can not afford private homeopathy so the likelihood of them being able to afford the legal costs involved in judicial review is practically zero. Of course, a crowd funding campaign would be possible but... 

The BHA has a history of "supporting" NHS homeopathy although that seems to consist mostly of stirring up supporters of homeopathy to respond to public consultations, sign petitions and write letters. It isn't clear what, if any, money it has put into this. It could be argued that the BHA does have standing on the basis of its stated aims on the Charity Commission website which includes campaigning and fundraising for "access to homeopathic services" but again the issue of Anthroposophic medicine rears its head. It is also worth pointing out that all things considered, the BHA has failed conspicuously in this "support". At best it may have managed to delay the decision of a few NHS bodies to remove homeopathic provision but not to prevent.

Other grounds for rejection were discussed in the previously mentioned post but there is another ground for dismissal of an application. The judicial review process is not one of fact finding (although this may take place). It concerns itself with matters of whether processes have been conducted legally, fairly and inline with any stated procedures/guidance. Cross-examination is rare. There is a "duty of candour" placed on parties - they are expected to be open and honest in their statements and dealings with the court. It is likely that a judge would take a dim view of "whataboutery". They are also expected to be honest about weaknesses in their case. Of course, the BHA are employing solictors to prepare their application however their solictors will be to a degree be dependent on the BHA for certain details - after all they are not experts in homeopathy, they are experts in public law.

As previous posts have pointed out, there are questions about the information that the BHA has presented to the public. They have uniformly depicted the Consultation as an attempt to "ban" NHS England prescribing of homeopathic and herbal medicine. Strictly speaking, the purpose of the Consultation was to produce guidance. NHS England and CCGs do not have the legal powers to prevent prescribing of such products - that lies with the Department of Health and Social Care and its ability to blacklist. The previously mentioned analysis of GP prescribing data shows prescribing happening despite CCG policies against. It is suggested that depicting prescribing by Anthroposophic GPs as "homeopathy" is a weakness in the BHA's case.

It might be thought that the lack of compelling evidence for homeopathy having any efficacy beyond that which is consistent with placebo is a weakness. The purpose the application and any resulting judicial review is not to determine the efficacy of homeopathy although the judge may think it pertinent.

There is no obvious case law to compare the BHA's application with. Whilst the dismissal of the application for judicial review by Honor Watt (acting, effectively as the BHA's proxy) may seem highly relevant, it related to the decommissioning a secondary care service by a local NHS body, not the issuing of prescribing guidance by a national NHS, which is arguably a much lesser thing.

It is worth pointing out that the granting of a rolled up process does blur the lines between the application for judicial review and the judicial review itself. Unfortunately, this makes discussion difficult in terms of exactly when in the process the Court may reach certain decision points.

To quote again from the crowd funding campaign -
The judicial review seeks, among other things, a declaration that NHS England has acted unlawfully in relation to its proposals and subsequent decision, on the basis of its failure to consult on them properly and to listen to patients!
This is a very aggressive statement. It seems very unlikely that any solictor would make such a statement. Arguably, the BHA are setting themselves up for failure and are making the assumption that their application will be accepted.

One element of the BHA's claim is that patients and "experts" have not been consulted. This seems strange in that this is the point of a Consultation. To claim that the Consultation paper itself should have been drafted with consultation with these groups is a baroque argument to say the least. That Anthroposophic GPs and their patients should enjoy some special consideration seems strange, unless the BHA has evidence (and the bar is set very low in terms of evidential standards) that there is a legal or procedural requirement to do. If the BHA has evidence that GPs who prescribed any of the other products and their patients recieved some sort of special consideration, there might be grounds for a claim of unfairness but that would not necessarily have any bearing on the outcome of the consultation.

The BHA do not specify who these "experts" are but it is clear that the BHA et al are dismissive of any one who does not agree with their assertion that homeopathy is effective.

The BHA assert that the Consultation "did not provide consultees with adequate information on which to provide a considered and informed response". Again, if the BHA has evidence to suggest that evaluation of homeopathy requires greater information compared to the other medicines/products included in the Consultation, or that consultees were provided with "adequate" information them, then there might be unfairness grounds for the application.

They go on to state -
We are also challenging NHS England’s decision to go ahead with the proposals and publish national guidance that homeopathic medicines should no longer be routinely prescribed by GPs.
On what grounds is unclear. It could be that the BHA believe that this is unreasonable action to take. Considered on its own, how could the decision to issue (unenforceable) guidance be seen as unreasonable in regard to the responses to the Consultation etc? Public consultations are not referendums. They are not popularity contests. It must be remembered that the BHA et al did mount campaigns to solicit Consultation responses from their supporters. Even if unfairness could be demonstrated above, that would not mean the decision unreasonable.
We are concerned that NHS England has failed to consider the effect of its decision on those patients with protected characteristics, in breach of the Public Sector Equality Duty (PSED).
This would look at first glance to be the mostly likely grounds on which an application might be granted. However, NHS England did carry out an equality and health inequalities analysis. It necessarily has limitations due to the nature of prescribing data. The raw does not include "protected characteristics" which are -
  • age
  • disability
  • gender reassignment
  • marriage or civil partnership (in employment only)
  • pregnancy and maternity
  • race
  • religion or belief
  • sex
  • sexual orientation
NHS England were able to use age and gender in their analysis. This explanation of "protected characteristics" is helpful. Not all of this data is routinely recorded by the NHS and the holding of this data and especially its usage is of concern qv Caldicott Report. From a pragmatic data analysis viewpoint, it would likely involve the use of GP clinical systems data and experience suggests that the cost involved would be considerable and would divert analytical resources from supporting NHS operations to defending NHS England against what is essentially a trivial concern from a fringe group.

It is not simply enough to wave around PSED as a justification for an application for judicial review. Again, it must be stressed that the evidential standards involved in the consideration of an application are quite low, but the BHA would need to be able to demonstrate that NHS England has not fulfilled PSED obligations - which would be difficult unless they had canvassed patients of Anthroposophic GPs for demographic data and de facto the BHA do not know those those persons are. The BHA et al can commission consumer research but what currently exists is very weak and can not form the basis of their argument. If they did commission research it would needed to be shared with NHS England.

Something that that is relevant to PSED arguments is that the majority of GP practices in the UK do not prescribe homeopathic medicines. 

Hang on a minute...
Something that needs to be understood is that as part of the application process is that the claimant (in this case the BHA and its solicitors) needs to share with the defendant (in this case NHS England) their submission, so that the defendant can can prepare their rebuttal. This may already have taken place. And the defendant needs to share their submission with the claimant. The claimant's solicitors could suggest to their client that the defendant's submission is too strong to argue against. Of course, a client has the right to press on regardless of advice, but ...

Rejection of Application etc
It is possible that the Court may take the view that as parties have already incurred legal costs preparing for a "rolled up" hearing they might as well be have their "day in court". The question of rejection may not arise. This would be odd - it is essentially a waste of court time. There are other reasons why the Court may grant permission but they are not necessarily positive. For example, the Court may grant permission for judicial review not on the merits of the arguments of the BHA but to protect NHS bodies from further actions by the BHA etc. This will be discussed later.

If the Court does reject the application, they will state the reasons. The claimant does have a right to verbal appeal but if the Court believes that the application is "totally without merit" that verbal appeal can be denied. There is no automatic right of appeal beyond this. The Court of Appeal can be approached to grant permission for judicial review but obviously this incurs further legal costs and the likelihood of success is obviously low. The Court of Appeal may well be minded to disregard approaches where the intial application was "totally without merit". Further appeal to the Supreme Court is possible but the bar is set very high in terms of matters they will consider.

Whether the BHA has the funds to pursue an appeal is moot. 

Judicial Review
As hinted at earlier, judicial review differs from other court proceedings. They are not trials. They are concerned with whether process has been conducted correctly rather than establishing the fact of guilty/liability. There is no jury, only a judge (although in unusual circumstances, a panel of judges is possible).

Typically, the claimants barrister will speak first, then the defendant's and finally the claimant's barrister will make a brief statement before the judge makes their decision. The skeleton of the arguments will have already have been submitted to the Court. There is an emphasis on efficiency - courtroom theatrics are frowned upon. Witnesses may be called but this is uncommon - generally, written submissions are considered sufficient. Cross-examination of witnesses is not forbidden but would be a rare departure from the established process. Judgement is generally not given on the day ("reserved") and tends to be in written form.

Whilst the BHA themselves may wish to call witnesses, it is likely that the kind of witnesses the BHA would favour would not be credible in the eyes of the Court.

The Court makes determination based on the facts presented to them. It is important to re-iterate that the Court will not concern itself with determining the efficacy of homeopathy - the Court is very likely to take the position that homeopathy's lack of efficacy has been sufficiently well established to be treated as fact.

(Homeopathy being "put on trial" is more likely to happen in negligence cases and even then may revolve around the negligence of a person than the use of homeopathy.)

No new ground will be covered in the hearing compared to the written submission - matters are simply discussed in greater detail, especially those of a more legal and/or technical nature.

Once judgement has been reached, applications for costs will be considered. The general rule is that the loser pays the winner's costs. Public bodies such as NHS England do necessarily have access to greater funding than bodies such the BHA (although they would rather not spend taxpayers' money in this way). Because of this, some arrangement regarding costs may be reached earlier in the process. Whilst the BHA has some crowd funding monies in place, in the case of them losing, these monies would not cover NHS England's costs. The BHA's solictors will have advised them of this.

The potential outcomes of judicial review were discussed in a previous post. Whilst the BHA stated that they wish for the Court to declare the Consultation illegal, from a more practical point of view, they probably want the decision of the NHS England Board to issue guidance to CCGs on the prescribing of homeopathic and herbal medicines quashed. If the arguments of their solicitors are not framed in the right way, this will not happen.

Similarly, whilst the BHA do not state it, they would probably want NHS England to withdraw their recommendation to the Department of Health and Social Care to "blacklist" homeopathic and herbal medicines. Again, this would depend on the framing of the application and submissions to the Court.

It is difficult to be certain as to the exact implications of any particular outcome except the BHA will certainly look bad if they lose. How bad will depend on the language of the judgement.

There is a question as to whether a judgement in favour of the BHA would open up questions about other elements of the Consultation and the decisions made and whether they would be then potentially subject to legal challenge. There do not seem to be any groups, say, actively campaigning for GPs to be able to prescribe dietary supplements but, in theory, if there were such a group with sufficient standing, it could challenge.

In the incredibly unlikely event that the Consultation and/or the decisions based on it were judged illegal, chaos would ensue. It would effectively raise the bar of the level of analysis that public bodies would have to do to ensure PSED was satisfied and effectively set a precedent allowing challenge of any recently made (or future) decisions made using that level of analysis. In the case of historical decisions, it would be more of a question of how policies are currently implemented.

Some CCGs have explicit policies against the prescribing of homeopathic and herbal medicines. Some have an implicit policy in that they have locally agreed formularies which do not include herbal and medicines. It is possible that certain judgements would allow these policies to be subject to judicial review. No judgement would have the power to undo these policies though. Whether the BHA has the appetite or funding to launch yet more judicial reviews is unknown.

It is important to remember that NHS England can not "unsay" the conclusions of the Consultation or the decisions of the Board. The Board could be prevented from issuing explicit guidance to CCGs but it would not prevent those CCGs that do not already have a de facto policy against prescribing homeopathic and herbal medicines from implementing one, although they might be more mindful of PSED requirements. The Board could be made to withdraw its recommendation that homeopathic and herbal medicines are "blacklisted". The Department of Health and Social Care's attitude towards "blacklisting" is unknown - the impact of withdrawal is moot.

Some of homeopathic and herbal products are on the General Sales List. They potentially can be dealt with by the OTC part of the Consultation etc without even invoking the words "homeopathic" or "herbal".

Both the claimant and the defendant have the right of appeal to the Court of Appeal - but again it is a matter of applying for appeal and the likelihood of an application being granted will depend very much on the language of the judgement (eg "totally without merit"). It would seem unlikely that the BHA could afford an appeal and whether supporters would want to contribute to yet another crowd funding campaign.

The BHA would find their position decreasingly tenable as costs increase. Essentially - why are they wasting supporters money when that money could be used to pay for the homeopathic medicines of those who can not afford them?

Whether NHS England would appeal would depend very much on the nature of the judgement. If it does not impinge on other aspects of the Consultation and the decisions made by the NHS England board, they make take the view that as prescribing is in decline, simply to allow that decline to continue. However, they might take the view that protecting CCGs from judicial review would be strategic.

Further Discussion
Of course, this raises all sorts of questions about the strategy and tactics of the BHA. It is proposed to discuss these in a further post. They were not discussed here - it would have distracted from the main point of the post.