Tuesday, 12 June 2018

Homeopathic Treatment of Autism - Evidence #5

That the Society of Homeopaths (SoH) finally managed to meet the Conditions placed by the Professional Standards Authority (PSA) on their reaccreditation does suggest suggest that it is worth looking at members websites and so on.

It is worth pointing out that some further analysis has been done on CEASE and the related Homeopathic Detox Therapy (HDT) practitioners. This is worth blogging about in its own right but one thing it did reveal is that the numbers of SoH members potentially offering these bogus therapies is higher than initially thought. There are more than 110 of them. Given that the SoH has roughly 1,100 members - including students - this is a significant proportion of their membership.

Previously mentioned
Whether is too soon to expect members to have begun the process of voluntarily updating their websites depends on your point of view but it is at least a week since the SoH will have informed members via their email newsletter. Of course, members may not read the newsletter and if the history of the SoH is anything to go by, it seems unlikely that the SoH will have taken any steps to draw members attention to it.

This post mentions Usula Kraus-Harper and as it points out, it is likely that she would not be happy about being told to amend her website. It would appear she has not made any attempt to do so. This post mentions Jennifer Hautman and again, there seems to be no attempt to amend claims relating to autism.

Yvonne Stone
Stone is highly problematic. On her About Me web page she talks about training as a nurse after leaving school but -
I quickly realised I was not willing to take orders all day long, so I trained to become a midwife as they were more able to make independent decisions. I soon realised I wanted to be totally in charge of my own workload, so I went to work on the community and then I recognised that I also liked things done the ‘proper way’, so I became a manager.
Which suggests she make not take too kindly being told what claims she can and can not make by the SoH. Not that she makes many on her website for CEASE therapy - from the same webpage -
My most recent training was to become a Certified CEASE therapist. I can help children and adults whose health has deteriorated since having vaccines, anaesthetics, anitbitoics or other medication. 
However, this web page reveals Stone to be an anti-vaccationist. This is not permitted by the SoH. Stone says -
I am a Certified CEASE therapist and I have found that homeopathic medicines and good nutrition can help restore your child's good health. I co-run an Arnica Group in Colliers Wood. We meet once a month to talk about how to help our children grow up healthy and strong.  
Stone also links to the Informed Parent website describing it as "excellent" - it is extremely anti-vaccination even it pretends not to be. It is full of misinformation and scaremongering.

Worse still Stone co-authored with Liz Bevan-Jones the No Nonsense Vaccine Handbook. What exactly is in that book is unknown but this document  suggests it will be full of all sorts of bogus information. The decision to vaccinate is a no-brainer in the vast majority of situations. It contains "advice" such as -
It is unnecessary to vaccinate your baby (while you are still breast-feeding) for any disease you had naturally. Breast milk contains long-chain sugars necessary to develop a healthy immune system. The mother’s antibodies last for 3 months beyond the time she finishes breast-feeding.
The UK vaccination schedule includes vaccinations for some very serious diseases. Breast  milk may not contain significant, if any, levels of antibodies to most of these diseases. But worse -
Use homeopathic nosodes to protect your children from diseases which are epidemic. They are simple to take and enable the immune system to operate as nature intended without toxicity or unpleasant side-effects. See pages on Homeopathic Prophylaxis and Nosodes. Further information on nosodes can be found in the No Nonsense Travel Vaccine Handbook. 
Use of homeoprophylaxis is described in by the SoH as -
Currently there is no homeopathic alternative to vaccination or anti-malarial drugs which has been proven beyond doubt to be clinically effective. It is therefore unethical for a homeopath to advise a patient against the use of conventional vaccines or anti-malarial drugs.
Stone would appear to be in breach of this in spades.

Stone offers Mannatech products. Mannatech is notorious for bogus marketing claims as well being a multi-level marketing scam. The claims made for these products are not compatible with EU regulations and it is questionable whether they are legal in the UK.

Amanda Bate
Bate does not say a great deal about CEASE therapy or autism on her website. Here she talks about tautopathy -
This therapy is helpful if long term use of a drug or vaccination has caused a problem. I would discuss this methodology with you should I think you would benefit from it. It is a different way of using remedies. This method of homeopathy is used for some patients  with Autistic Spectrum Disorder or Aspergers or patients who have suffered side effects from The Pill, steroids, antidepressants and other medications.
Tautopathy is just another word for isopathy that is used in CEASE. Bate is implying very strongly that autism is caused by drugs or vaccination.

ASD and "vaccination side effects" appear in a list of conditions that patients come to see her about. Of course, the SoH seem to be taking the line these days that this is perfectly permissible as long as no claim to treat/cure is made.

Bate is an anti-vaccinationist and very open about it. She is an Arnica group leader. On her website there is a document Vaccination Choices. It is full of hearsay and anecdote - which is very much how groups like Arnica work. There is also this blog post. Bate also has a Facebook page where she is much more active in terms of post compared to the blog on her website. She seems very keen on the Children's Medical Safety Reasearch Institute - which is nothing of the sort. It is extremely anti-vaccination to the point of funding bogus research. It strongly pushes the line that vaccines cause autism but most disturbing of all are the attitudes of some of those that write for it. Bates may be blindly posting things without understanding any of this.

Arunjot Mushiana
Mushiana doesn't make any mention of CEASE on her website except to say that she's had "training". But she does make mention of it elsewhere, eg on her (probably abandoned) blog, on the Thames Valley Homeopaths website and just in passing on a couple of other websites. Her Twitter timeline does make relatively recent mention of homeopathy and autism though as well as recommending the Amy Lansky "Impossible Cure" book. Her entry on the CEASE therapy website is worrying.

Hi, I am a UK registered homeopath, having qualified from The London College of Homeopathy in1995. I have a busy local practice in Slough where I see patients from all over England as well as having international clients from countries including Sri Lanka, India, USA, Canada & Dubai. Although my first language is English I also speak fluent Punjabi. Please take a look at my website and feel free to write to me with your questions or to arrange a 15 min free Skype consultation.
International clients? Unless Mushiana is flying around the world or her clients are flying to her, does this mean she is conducting consultations with autistic children via Skype? This would be problematic to say the least as was discussed in this post in regards to Sian Collister.

Mushiana's website starts that she is an Arnica group in the Windsor and Slough area. It appears that is the co-leader is Sylvia Giunta - another member of the SoH and CEASE practitioner. How active this group this is impossible to tell and this tends to be the case with all local Arnica groups. Some have closed Facebook groups. There is a Yahoo group. Others may communicate by email.

Liz Bevan-Jones
Bevan-Jones' website no longer works and hasn't done for a number of years. However, online mentions of her do say that she has a busy clinic. On the other hand, there are some indications that she may no longer be practicing but it isn't terribly clear. She would still appear to be a member of the SoH.

Bevan-Jones did a seminar with Yvonne Stone in addition to writing a book with. Stone offers appointments at the same location as Bevan-Jones did. Arnica still shows Bevan-Jones as a local organiser for Colliers Wood although no mention is made of Stone.

In addition to CEASE, Bevan-Jones would appeared to be trained in HDT.

Sarah Kaiper-Holmes
Kaiper-Holmes mentions autism on her Rainbow Homeopathy website but no mention of CEASE therapy. However, she mentions her intention (obviously carried out) to study CEASE therapy on her Rainbow Babies website.
Sarah graduated in 2009 from The Centre for Homeopathic Education in London with a BSc(Hons) Homeopathy. 
Whilst studying for this degree, she completed her Masters degree in Autism during which she carried out a small-scale research project looking at using Homeopathy to improve the behavioural aspects of children with Autism.
This seems odd. BSc and MA at the same time? Kaiper-Holmes already had a first degree as well as a Postgraduate Certificate in Education so entry to the Sheffield Hallam part time MA Autism Spectrum course or whatever course came before it would not be an issue. The Centre for Homeopathic Education (CHE) no longer offer a BSc - Middlesex University removed accreditation - but even the full time version would likely few teaching hours.

The current MA Autism Spectrum course doesn't seem to have a research element. It seems unlikely that the "research" was part of her MA. The ethics of conducting medical trials on children are difficult and those on autistic children even more difficult. The likelihood of a university ethics board approving research using a treatment with no plausibility on vulnerable children is extremely low even if the treatment is harmless.

Arguably, the MA should mean that Kaiper-Holmes is competent to work with autistic children and adults but treating them? There is no way that the MA transforms a bogus therapy into a real one.
She spent four years running monthly homeopathy clinics at The Hesley Village & Fullerton House School (part of The Hesley Group) where children and adults have a range of special needs within the autistic spectrum.
The Helsey Group seem very sensible overall and homeopathy seems out of place. But they do not currently seem to offer anything of the kind.

Kaiper-Holmes makes the mistake of claiming that homeopathy can treat a list of conditions -

  • Acne, Arthritis, Allergies, Asthma, Autism, ADHD, Anxiety
  • Bruises, Bed-wetting, Bites & Stings
  • Constipation, Colic, Coughs & Colds, Childbirth, Cystitis, Chicken pox
  • Depression, Drug withdrawal, Diarrhoea
  • Eczema, Ear infections
  • Fertility issues, ‘Flu, Fever, Fatigue
  • Gynaecological problems, Gout, Grief, Gastric problems
  • Hayfever, Headaches, Heartburn
  • IBS, Insomnia
  • Labour, Lethargy
  • Menopause, Menstrual problems, Migraines, Measles, Mumps
  • Pregnancy, PMS, Panic attacks
  • Respiratory complaints, Rashes
  • Sports injuries, Shock, Sunburn/sunstroke, Stress, Sore throats
  • Tantrums, Teething, Tonsillitis
  • Vomiting, Verrucae & Warts
This is not permitted by the SoH.

The Rainbow Babies website reveals that she is a local Arnica group leader. The group seems active in that it meets monthly on a social basis. Given Kaiper-Holmes' business interests, this likely gives her access to a ready market for her services. The role of this kind of social network, mouth of mouth recommendations, and so forth can not be underestimated. It may explain why some SoH members do not advertise online, especially if the are part time.

Again, it is impossible to know if Kaiper-Holmes actively offers CEASE therapy within these groups but they are likely to be receptive.

Silvia Giunta
Giunta does make mention of CEASE therapy and autism on this page. She links to the CEASE therapy website. She also states -
Silvia Giunta is a Homeopath & Neurodevelopment practitioner working with : Dyslexia, ADD, Neurodevelopmental Delay, Hypermobility
"Neurodevelopment practitioner"? Neurodevelopmental practitioner is a term used to describe some highly specialist paediatricians (especially those involved with the diagnosis of autism) but Giunta is not one of those. Neurodevelopmental delay is an odd term - generally the term neurodevelopmental disorder is used - and is often a euphasism for autism.

Giunta also mentions CEASE on the Thames Valley Homeopaths website which does seem to be a nest of CEASE practitioners. Giunta is also qualified in HDT. Giunta would also appear to be a Brain Buzz practitioner as well as offering Sensory Activation Solutions therapy. To top it all, she uses the bogus Asyra machine (which is very similar to the ZYTO machine). What the SoH will make of such machines is unknown, given the illegality of the claims made for them. 

It's worth pointing out that Giunta charges a lot for consultations - even relatively short Skype ones. Giunta also seems to be involved with a purveyor of bizarre diets and valueless tests.

Sophie Knock
Knock has a page on CEASE. It does not make for good reading. Nor does the Asyra nonense or the involvement with Arnica. It's a full on claim for the bogus "benefits" of CEASE with multiple links to the CEASE therapy website,. The kind of thing that the SoH are supposedly concerned about.
CEASE Therapy stands for Complete Elimination of Autistic Spectrum Expression . Step by step all causative factors (vaccines, regular medication, toxic exposures, etc.) are detoxified with the homeopathic diluted and potentized substances that caused the autism.
Perhaps Knock did not get the email? Knock also links to various articles about the bogus trial in Cuba that involved homeoprophylaxis against leptospirosis. Some of the links don't work and those that do - well, the articles are as poor as you might imagine. But this one is interesting in terms of the comments and who turns up there. Gina Tyler for example - a US homeopath who is deeply anti-vaccination

Thursday, 7 June 2018

NHS Homeopathy #6 - British Homeopathic Association lose Judicial Review

The British Homeopathic Association's (BHA) application for judicial review of NHS England's (NHSE) consultation Items which should not be routinely prescribed in primary care: A Consultation on guidance for CCGs (Consultation)  and subsequent guidance was discussed here at great length.

The application was accepted. The hearing took place between 01/05/2018 and 04/05/2018. The ruling of Justice Supperstone was published on 05/06/2018.

Supperstone ruled against the BHA.

Preliminary detail
The ruling reveals the BHA made application for judicial review on 20/10/2017 and that the rolled up hearing was ordered by "Yip J" on 20/12/2017. It must be stressed that granting of a rolled up hearing - where the application for judicial review and the review itself are (potentially) heard together - is unusual and potentially wasteful.

As part of the judicial review process, both sides will have made written submissions to the Court - which they also would have to share with each other. These submission can be obtained by Freedom of Information Act 2000 (FOIA) requests but it is unlikely that they would add much. However, the ruling does contains some hints of the what was in them. Interested third parties could, in theory, also have made submissions at this point. It is unknown whether this is the case. Two interested third parties - the Patients and Friends of Anthroposophic Medicine and the Friends of the Royal London Hospital for Integrated Medicine - are mentioned but did not actively take part in the hearing.

The BHA amended their application on 22/01/2018. They also effectively made another amendment on 16/04/2018.

Legislative and Factual Background
The ruling contains information on the relevant legislation but it is very dry reading. There is also a section that details the process of the Consultation. There is nothing particularly remarkable about this if one is familiar with how public consultations work.

Grounds for Judicial Review
The BHA started off with nine grounds but (likely on legal advice) these were reduced to four, which are -
  1. NHSE failed to consult fairly by failing to provide consultees with sufficient information to enable them to give a meaningful response to the consultation and failing fairly to summarise the homeopathy issues the consultation was considering and/or NHSE misled consultees and/or failed to consult on alternatives
  2. NHSE failed to consult at a time when proposals were still at a formative stage and/or there was a substantial risk that it had pre-determined its decision to withdraw support for homeopathy
  3. NHSE has breached the public sector equality duty contrary to s.149 of the 2010 Act
  4. NHSE has no power to issue the Guidance under s.14Z10 of the 2006 Act
Point 4 was added very late in the day. Point 1 is the crux of the BHA's argument and merits further discussion. There are several elements to it -
  1. NHSE has failed to give sufficient reasons for its proposal to permit of intelligent consideration and response
  2. NHSE failed fairly to summarise the homeopathy issue the consultation was considering
  3. Having placed reliance upon the 2010 Report of the House of Commons Science and Technology Committee ("the 2010 report") NHSE failed to place the report properly in context
  4. NHSE misled consultees and/or failed to consult on possible alternatives to its proposal
The ruling then goes onto discuss several important cases revolve around fairness.

Something interesting to note is that the BHA did want to an "expert" witness statement from Dr Peter Fisher to be considered as part of their submission, yet this was withdrawn during the hearing.

Submissions and discussion
Typically, in a judicial review hearing, the complainant's barrister talks through their client's submission, then the defendant's barrister will talk through their's and finally the complainant's barrister will speak again. Remember, that both parties will have seen the other's submission. No cross examination will take place.

The ruling is not a transcript (transcripts tend to make for very dull reading). What is does do is examine the points in the BHA's submission, NHSE's response to them and discusses them before making a specific judgment about the point.

Perhaps the BHA's position on Point 1. fairness is best summarised by -

  1. Summarising the Claimant's case on day one of the hearing, at the outset of his oral submissions, Mr Clayton described it as a fairness challenge to the consultation based on the view in the consultation document that homeopathy is not clinically effective. He said that the consultation process was unfair because it misrepresented the true position; there is, he contended, plain evidence that homeopathy treatment does work in particular cases; and what the case boils down to is a debate about scientific method.
Richard Clayton was the barrister representing the BHA. Much was made of the NHSE's "reliance" on the 2010 Report of the House of Commons Science and Technology Committee (Report 2010) and that it somehow misrepresented understanding of homeopathy. That there was a failure to mention the Government response or that there had been an Early Day Motion signed by a number of MPs. Clayton stated that the Report 2010  "was seriously unbalanced and inaccurate and NHS England acted unfairly in failing to provide a fair summary of the complex issues it was consulting upon."

The original consultation document did state that - 
In 2010 a report by the House of Commons Science and Technology Committee, found that the use of homeopathy was not evidence based and any benefits to patients was down to placebo effect. The group agreed with the findings of the committee for the lack of evidence and considered homeopathy suitable for inclusion in the proposed guidance. 
The opinion that the Report 2010 is "seriously unbalanced and inaccurate" is a minority one and the NHSE consultation document is a fair reflection of the conclusions. The consultation document does not say anything that is out of line with medical and scientific consensus.

Clayton goes on to claim that referring to the Report 2010 is problematic for a whole host of other reasons such as "not intelligible to the ordinary consultee". Clayton also made arguments over the meaning of words and phrases such as "efficacy" and "clinical effectiveness".

Supperstone did not agree.

  1. I reject Mr Clayton's submissions on the Gunning (2) criteria, essentially for the reasons advanced by Mr Jonathan Moffett QC, who appears for NHSE. I agree that the information that was provided to consultees was sufficient to enable them to give a meaningful response. Supporters of homeopathy could not have been left in any doubt that they needed to provide NHSE with evidence that homeopathy actually works; and this is exactly what the Claimant sought to do.
Moffett was the barrister for NHSE. And later.
  1. It was made clear to consultees that the reason why NHSE was proposing to include homeopathy on the list of items that should not routinely be prescribed by GPs was the lack of robust evidence that it actually works. Consultees therefore knew that, if they opposed the proposal, they should point to evidence that homeopathy actually works, and they were afforded the opportunity to submit such evidence. The fact that the Claimant did exactly this indicates that certainly it had sufficient information to provide an informed response.
Particularly telling is -
  1. Mr Clayton argues that there is "a legitimate scientific debate" as to whether homeopathy works. However I agree with Mr Moffett that it would not be appropriate for the court to pass judgment on the legitimacy or otherwise of the view that homeopathy works. NHSE accepts that there is a body of opinion, to which some practicing clinicians adhere, that homeopathy works (and that there is evidence to that effect), as the Select Committee report made clear. On the other hand, as Mr Moffett points out, representatives of professional organisations such as the Royal College of General Practitioners, the Royal College of Pharmacists, the British Medical Association and the Academy of Royal Medical Colleges sat on the Working Group and were involved in the development of the guidance. In any event the legitimacy or otherwise of the debate is not relevant to the issues before the court. What NHSE was consulting on was its provisional view that there was no robust evidence that homeopathy actually works.
This has implication for the context and scope of the hearing. Homeopathy is not "on trial".

As for Point 2, that NHSE had already come to a determination, Clayton's arguments revolved partly around a Radio 4 interview given by Simon Stevens, NHSE's chief executive on 31/03/2017 (several months prior to the official launch of the consultation and before any decision as to include homeopathy in it) in which when asked a direct question about homeopathy responded that homeopathy was ineffective and a waste of money. They also revolved around wording in the press release of 21/07/2017 that homeopathy is "at best a placebo and a misuse of scarce NHS funds". Clayton argued that both represented determination and the Stevens' statements represented the corporate opinion of NHSE.

Supperstone stated -
  1. I reject this submission. In circumstances where NHSE was putting forward the proposal to consultees on the basis of an assessment of the evidence as to whether homeopathy actually works, I consider that NHSE was entitled to form a view on the state of the evidence before going out to consultation. It does not follow from that that NHSE had closed its mind to any further evidence that might be provided by consultees or that it would not objectively assess that evidence if it were received. The evidence is that NHSE engaged with the Claimant during the consultation exercise (see para 25 above), that the Claimant's written response was given careful consideration and that the SPS was instructed to conduct a specialist review of it (see para 27 above). Ultimately the decision of NHSE was made at a Board meeting and each Board member agreed with the decision. It has not been suggested that Mr Stevens exerted any undue influence over other members of the Board.
Point 3 about Public Sector Equality Duty (PSED) is quite tortuous to read but some interesting points appear. The basis of Point 3 -
    i) The consultation process was exclusively online and, therefore, excluded some people with protected characteristics from answering the online consultation and from attending face to face events because the only way to find out about them or book a place was online.
    ii) NHSE failed properly to inform itself and to take the necessary reasonable steps to gather relevant information in relation to specific protected groups.
    iii) The EIA at no stage considered the impact of removing the exemption on paying NHS prescriptions on those with protected characteristics, particularly the elderly and those with disabilities.
    iv) The consultation did not differentiate between removing single items of medication which treat one or two conditions from the prescribed list and removing the entire range of homeopathic treatments which are used to treat a very significant number of conditions.
    v) The EIA failed to identify the increased impact on those with protected characteristics which results from de-prescribing homeopathic treatments, unlike other medications listed in the consultation paper, for which one or more identified alternatives are readily available.
It would appear that one of the BHA's ideas was that NHSE should examine every single prescription to determine whether patients were exempt from prescription charges. This would be impractical for a whole host of reasons as well as being incredible expensive.

Supperstone was more than satisfied that NHSE had fulfilled PSED. This is particularly interesting -
  1. Mr Moffett makes the point that the first of these criticisms, that the consultation process was exclusively online, can only be a challenge to the decision as to how the consultation exercise was to be carried out. That decision was taken by the Board at its meeting on 21 July 2017. However, that aspect of the Board's decision was not challenged in the claim filed in October 2017; it was not raised until the amended grounds were filed on 22 January 2018, six months after the relevant decision. The explanation for the delay given by Mr Clayton is that it was not until shortly before the filing of the claim that the Claimant received letters from two individuals which put it on notice as to the problem. However this does not explain why the claim was not amended to include this complaint long before it was. The Burkett principle, on which Mr Clayton relies, does not assist the Claimant in the present case where the decision to consult took effect when the consultation commenced. I would therefore dismiss this ground of challenge on grounds of delay alone.
It would be foolhardy to speculate on why there was such a delay. 
  1. As for the other three criticisms made by the Claimant (see para 78(iii)-(v) above) it is clear that the EIA did consider the impact of removing the exemption on paying NHS prescriptions on those with protected characteristics. The analysis proceeded on the basis that the effect of the guidance would be that patients who were previously prescribed homeopathic treatments would instead be prescribed the most effective medications that would achieve the best outcomes. That accords with the Claimant's consultation response which stated that patients who no longer receive homeopathic treatments on prescription will continue to use NHS services and move on to other prescription medications. The Claimant has not identified any further information that should have been obtained in relation to persons with conditions that are specific to particular protected characteristics.

  2. I am satisfied that NHSE was rigorous in the discharge of the duty to have "due regard" to relevant matters, and that it was entitled, on the evidence before it, to conclude that the Guidance would not have an adverse impact on the statutory equality objectives, but rather, as the Analysis found, "would [enable] patients to have access to the most effective medications to achieve the best outcomes". That being so, I agree with Mr Moffett, it was not necessary to consider mitigation measures, it being NHSE's view that there would not be any discrimination.
These paragraphs are particularly damning. Whilst the homeopathy is not on trial, the implication is that patients currently receiving homeopathy will benefit by being prescribing the most effective medication and that thus homeopathy is of no effectiveness beyond placebo.

Justice Supperstone's ultimate decision was -
  1. I consider that the grounds of challenge advanced at this hearing are arguable, albeit in the case of the vires ground, only just arguable. Permission will be granted on all four grounds. However, for the reasons I have given, none of the grounds of challenge are made out. Accordingly this claim is dismissed.
The language here is confusing. This is because the hearing was rolled up. The first two sentences effectively allow the application. The latter two effectively throw the judicial review out.

No mention is made of costs but it is possible that the BHA may have to pay NHSE's legal costs as they lost. Whilst the £30k+ the BHA raised via crowdfunding etc may (mostly) cover their own legal costs, it would not cover NHSE's and they can only be guessed at (although FOIA request could obtain them).

It is worth pointing out that the cost to NHSE goes beyond legal costs. Some staff will have been diverted from their normal duties to deal with this. 

It is unlikely that the BHA will appeal. Leave for appeal is unlikely to be granted and even if it were, unless they can magic up more compelling arguments an appeal would be extremely unlikely to suceed. There would also be the matter of costs - which would likely be higher than for judicial review. Whether supporters would fund an appeal is moot given the BHA's failure.

Whilst the BHA seem largely indifferent to negative publicity, losing in Court twice is unlikely to endear them even to the staunchest supporters of homeopathy.

There has been some media reporting of the BHA's failure. The Independent has a story as do the Daily Telegraph and Daily Mail. There also has been reporting in specialist media. Most of the stories quote Stevens -
There is no robust evidence to support homeopathy which is at best a placebo and a misuse of scarce NHS funds. So we strongly welcome the High Court’s clear-cut decision to kick out this costly and spurious legal challenge.
As previously mentioned, no mention of costs has been made. What is interesting is that some stories still paint the consultation results as a ban when it is clear that only blacklisting would be a ban. 

Social media reaction has been predictable. Critics see it as a victory for common sense and science, supporters of homeopathy are more mixed but some have invoked conspiracy theories as well as protraying the BHA as "brave". Bravery should not be confused with hubris. In relation to other NHSE matters, much has been made of Stevens having worked for UnitedHealth Group - some identify him with the "creeping privatisation of the NHS" but is has not been picked up. But both groups tend to forget that the judicial review concerned itself with whether the Consultation had been conducted correctly, not the validity of homeopathy as a treatment.

The BHA themselves describe themselves as brave in this statement
The BHA believed it had identified serious flaws in the way the health commissioning authority consulted the public on this issue and sought a judicial review.
Belief is one thing, the reality of the ruling something completely different. The whole statement is divorced from reality. Margaret Wylie, the chair of the BHA bizarrely stated -
It appears NHS England can fail to engage with patients properly on removing services and get away with it. That is not good enough, for it is important to remember that the real losers in this case are the patients who are now being refused a treatment on which they have come to depend.
There was also a statement on their crowdfunding page which covers much of the same ground.

The Society of Homeopaths contributed money to the BHA appeal that it call ill afford. Their news item has little to add but Mark Taylor as per usual had something to say -
It is hugely disappointing but it was encouraging to see the homeopathic community pull together to make the case. Through 4Homeopathy, we will ensure that the campaign to promote homeopathy and enable patient choice will continue.
The Friends of the Royal London Hospital for Integrated Medicine regurgiate a message from the BHA.

The ruling can only been seen a humiliating defeat for the BHA and CEO Cristal Sumner. It can also be seen as a defeat for UK homeopathy and its supporters. However, homeopathy is a fringe interest and NHS homeopathy represents a fraction of UK homeopathy. The BHA's defeat is unlikely to be of great interest to the public and only of passing interest to the media.

Critics of homeopathy have never regarded the BHA in a particularly favourable way but they have zero influence on the day-to-day activities of the BHA. They have some marginal influence when it comes to things like public consultations that the BHA become involved with but generally critics are less concerned in those circumstances with the reputation of the BHA and more the arguments they present.

Supporters of homeopathy tend to be uncritical of the actions of trade associations and bodies like the BHA. There is a tendency to support the "cause" even at various costs - including broader reputational damage as long as the key message plays to the core constituency. But in terms of financial support? The BHA are currently largely dependant on bequests and it's unpredictable income at best. They appear to have little in the way of active fundraising outside of that. True, they managed a crowdfunding campaign but on a very specific issue that they mislead supporters on.

What is going to hurt to hurt the most? Unknown, but several things but all will hurt.

From an activist point of view, it would be very easy to undermine the BHA in any future interactions that they might have with public bodies. There are some complicated legal arguments involved but the BHA have been shown to be not credible and unreliable.

Monday, 28 May 2018

Reaccreditation of the Society of Homeopaths

As discussed previously, the Professional Standards Authority (PSA) imposed conditions on the reaccreditation of the Society of Homeopaths (SoH). The PSA are now satisfied that the conditions have been met. There's more to this than meets the eye...

To recap, the conditions imposed on the SoH were -
1. The Society must:  
a. Develop and submit to the Panel for review its position statement on the use of CEASE therapy by registrants, including advertising this. This must be submitted to the Panel for review and published within three months  
b. Develop mechanisms to ensure that registrants who use and advertise CEASE therapy follow the Society’s position and do not breach its Code of Ethics and Practice. An action plan outlining how this will be achieved must be submitted to the Panel within one month  
c. Review risks related to CEASE and other therapies additional to registrants’ regular scope of practice, as part of its ongoing risk assessments. This must be incorporated into the Society’s risk matrix within three months.
Condition 1.b was met some time ago. A Freedom of Information Act request obtained the "action plan". Without getting bogged down in the detail, as to be expected the SoH did complain about timescales and how the "action plan" would be implemented. To quote -

There are four key points to the the plan:
  1. The establishment and the publicising of the Society's position on aspects of CEASE therapy
  2. The collection of data showing the Society which of it[s] members advertise and practice CEASE
  3. The surveying of the advertising and website claim by members who claims they are CEASE practitioners
  4. Providing clarity on what actions the Society will take for those members who contravene its stated position.
Point 1 is pretty dull but -

Once the wording of the statement is agreed then, within one month, the Society will:
  • Place the statement on the public area of the website
  • Run a news story on the home page of the website, including a statement of whare require of members
  • Inform all members in our weekly newsletter of the Society's position on CEASE accompanies by a copy of the statement
Oh dear. That's not what the condition (b) stipulated. Misreading by the SoH is not uncommon. It seems to be a common trait in homeopathy. 

Regarding Point 2, the SoH complains that it does not know which members have had CEASE training or how many of them practice it. The SoH accepted that it needs to monitor websites etc to ensure compliance. The SoH says that Point 3 is difficult - from experience, it isn't and the correct tools can make the job a lot easier. What is much more difficult is determining whether members actually practice CEASE therapy and to what extent they actively promote medical neglect. Some may simply have had the training and never had any interaction with autistic children. It's also said that lay homeopaths can pick up trade by word of mouth, personal recommendation etc without the need to invest in a website. It's known that some of these recommendations occur in closed Facebook groups (including Arnica ones).

Point 4 is where things start to get interesting.
  • Those members whose websites are found to be in breach of guidelines are contacted by e-mail, highlighting the concerns requesting that changes are made within 30 days.
  • If the member refuses to make changes and the issues are in breach of the Society's policies and/or Code of Ethics, the matter is referred to the Society's Preliminary Investigation Panel for further investigation as per the Society's Professional Conduct Procedures.
  • Ultimately members who refuse to comply can be removed from the register.
Something that needs to be pointed out here is that the SoH has a poor history of dealing with all but the most serious breaches of their Code of Ethics. It was only under pressure that they acknowledged that CEASE therapy is a problem and even then, squirmed.

Accepting Risks
The SoH did eventually accept that CEASE therapy advocates harmful practices yet asserted that members did not engage in them. How it knew this when it also claimed that it did not know that which members engaged in CEASE therapy is moot. It appears an over optimistic assumption. The evidence collected on this blog (see this and Jennifer Hautman in particular) suggests very strongly that there are UK lay homeopaths who do engage in harmful and unethical practices. There is evidence that has not been published here yet.

At the time of writing the SoH is yet to publically announce their position statement on CEASE therapy but this bullish blogpost by CEO Mark Taylor in response to a Guardian story (which broke as the SoH were having their Annual General Meeting) is problematic. To quote -
What is the perfect antidote to spending most of a day grappling with a journalist who wants to run a simplistic and lazy attack on homeopathy in a national newspaper?
Whilst the message may have been aimed at SoH members, it appears in a public area of the SoH website and was written at a time when presumably the SoH were still coming up with their position. "simplistic and lazy attack"? Public reaction as demonstrated on this Mumsnet thread was one of "surely this is child abuse?" and "how is this legal?" Taylor is clearly very out of touch with public sentiment. Taylor goes onto say -
Websites are also meeting places, allowing members to gather news and information, learn, research and discuss – largely away from prying and hostile eyes.
Taylor is obviously discomforted by scrutiny. The SoH can not be described as transparent. It is very likely that it is poor at communicating with members.

The SoH had previously agreed with the PSA that it would conduct an audit of a sample (30) of member websites biannually. The audit essentially checks that websites comply with the CAP Code. The SoH wanted to deal with a number CEASE therapy websites as part of this. The PSA were insistent that this would take far too long (2+ years) and would potentially leave the public (especially children) at risk. Notionally, the audit of members offering CEASE therapy will be complete by the end of 2018.

But these audits are problematic. The SoH appear to be taking the line that is permissable for members to make reference for named conditions (except for notifiable conditions). This would appear to be based on the notion that the Advertising Standards Authority somehow recognise PSA accreditation of the SoH as meaning that members are somehow "suitably qualified" (something given credence by this CAP statement). This is problematic as legally, such claims are not permitted (see here) for homeopathic products - and thus by extension by homeopathic practitioners. This places the SoH at odds with its own Code of Ethics that makes Blue Guide compliance mandatory. These audits only concern themselves with breach of a somewhat convenient interpretation of voluntary advertising regulations rather than legal compliance. Looking at member website that mention CEASE therapy is not just about marketing claims, it's very much about visible event of risky behaviour and non-compliance with mandatory guidelines on practice - a very different thing. (It's also bizarre that the ASA might permit advertising from a SoH member but rule against identical advertising from a non-member with equivalent "qualifications".)

Position Statement
The FOIA return did not include any detail on likely back and forth between the SoH and PSA (this is being awaited). It is expected that the SoH would aim for the least damaging wording. It appears on a webpage with other position statements (on homeoprophylaxis - bogus homeopathic preventatives - and vaccination. This page and its antecedants have been more or less visible over time. The statement on CEASE therapy merits dissection -
The Society of Homeopaths appreciates that its registered members use different methodologies and adjunctive approaches and embraces diversity within the homeopathic community. We consider diversity to be healthy and appropriate to the demands of an informed public.
Embraces diversity? Anyone familiar with the history of homeopathy will know that a lot of it consists of arrogant men claiming they do homeopathy right and everyone else is doing it wrong. Adjunctive approaches? Many homeopaths do not see homeopathy as adjunctive (complementary) - they see it as an alternative to conventional medicine and CEASE therapy as per Smits is very anti-conventional medicine. If the statement relates to the use of nutritional supplements etc in CEASE therapy, there's the issue of lack of training in nutritional science (as opposed to bogus "nutritional therapy").
CEASE is a therapy designed by Dr Tinus Smits in the Netherlands. A number of Society members have been trained in CEASE and make reference to it in their marketing. While this is acceptable, members should be aware the title, meaning ‘Complete Elimination of Autistic Spectrum Expression’ is misleading. RSHoms must not suggest that they are capable of a complete cure of autism as this would be unethical and in breach of the Code of Ethics.
No. In terms of what the law says, it is not just "cure" that is the problem, it is the (implied or explicit) claim to treat autism. It is possible that the SoH will provide more detailed guidance to to members but, again, given the history of the SoH, they may not.
The Society does not endorse any aspects of CEASE therapy contrary to NHS guidance and nor should RSHoms. In particular on vaccination, homeopathic prophylaxis, and the use of dietary supplements. It is beyond standard homeopathic practice to provide advice on the use of supplements and therefore any guidance given should be in line with the NHS Guidelines
Does the business of NHS guidance on supplements apply more broadly? What about other NHS guidance? This guidance states that "Currently, NICE doesn't recommend that homeopathy should be used in the treatment of any health condition." and "If you choose health treatments that provide only a placebo effect, you may miss out on other treatments that have been proven to be more effective." Does that apply?
The Society expects its members to comply with its Code of Ethics and statements on vaccination and homeopathic prophylaxis at all times, and any breaches may be treated as disciplinary matters. In order to ensure patient safety and In line with our guidelines, we will check the websites and marketing of all our members on a regular basis to ensure they are adhering to this statement.
The SoH are unlikely to be the only people checking on websites and marketing.

Best Practice
Yes, the position statement falls far short of what would be considered best practice in health and social care settings. There's no mention of safeguarding, autism awareness or competency for example. It must be pointed out that the PSA was not aware of them at the time that conditional reaccreditation occured. It can also be argued that the PSA is not in the position to impose best practice - it is really up to registers to adopt it - the PSA are more concerned with standards that relate to how registers are run.

However, as was made clear in this discussion of National Occupational Standards and the previously mentioned discussion of the reacrreditation, the SoH's Code of Ethics does place duties on the SoH and its members. There is a certain irony that by aping the forms of regulated healthcare professions in an attempt to gain credibility, the SoH has lost credibility by failing to live up to them. 

Even if the SoH do not adopt (all) best practice principles, there is nothing to stop individual members doing so. For example, the National Autistic Society offer online autism awareness training at the very reasonable price of £36 per module. The SoH should recognise this as Continuing Professional Development (CPD). The NAS even offer a safeguarding module. Of course, there are other training providers. There are also CPD courses in self-evaluation that are well suited to some working in health and social care. And so on. It is worth pointing out that these courses are often cheaper than CEASE therapy et al training.

In short, CEASE therapy is not safe. By extension homeopathy as a whole is not as safe as it is made out to be. The SoH have been forced to admit this.

The SoH often shows one face regulators et al, another to members. It is obvious that as a body it craves "official" recognition and so forth. But it is losing members, it is running at a deficit and whilst it has sufficient financial reservers to weather recruitment problems, reduction in income and increased costs for a few years, there are questions over its long term viability. The face that the SoH presents to the public is partly governed by a joint strategy by various homeopathic trade associations (via the 4Homeopathy group). Much is made of the safety and lack of side-effects of homeopathy. The SoH makes a great deal out of PSA accreditation but it is likely that consumer awareness of the PSA is very low and it is unlikely to make a difference to consumer behaviour.

It's odd that the SoH makes so much out of PSA accreditation to differentiate themselves from trade associations yet uses the Findahomeopath website - which includes other non-accredited registers. Yes, the SoH have it's own little page that mentions accreditation etc but the search facility makes no mention of this. If the SoH really believed that accreditation somehow embues members with superiority, why both with the website? It's is noted that the SoH has at times expressed disappointment that the PSA doesn't do more to promote accredited registers. This is a misunderstanding of the PSA's function. It is an exexcutive body of Government whose primary responsibility is the oversight of regulators of the legally recognised professions - not a commercial organisation that exists to promote the interests of accredited registers whose members are not legally recognised in anyway.

Given this, the PSA forcing the SoH to make a statement on CEASE therapy is humiliating but such is the price of retaining accreditation. It must be particularly humiliating for Mark Taylor. Whilst doubtless the Society will attempt put a positive spin on things, the media (who are very likely to pick up the story) will not. Social media has not really picked this up but this is partly because other media stories regarding CEASE therapy have grabbed popular attention in particularly this Canadian story and to quote -
B.C.'s top doctor says there are "huge potential harms" connected to a homeopathic treatment based on the unfounded claim that vaccines cause most cases of autism. 
Three registered B.C. naturopaths are the subject of a complaint to the College of Naturopathic Physicians because of the treatment, known as CEASE therapy — "complete elimination of autism spectrum expression." 
Provincial health officer Dr. Bonnie Henry told CBC News she was concerned to learn that CEASE is being offered in B.C. 
"It's certainly not based on science. It's based on a belief system," Henry said. "My big concern is that it really misleads parents into believing that immunizations are a cause of their child's autism."
That someone almost equivalent to Professor Dame Sally Davies speaks out against CEASE therapy is telling.

The SoH has been slowly losing members over time and the vast majority of its income is from membership fees. The SoH has engaged in a number of initiatives to stabilise/increase membership and thus revenue but has not had much success. These initiatives cost money. The SoH also commissioned a new website. It is currently running a deficit. Whilst it may have sufficient reserves to run at a deficit for several years with current membership levels, its financial future is by no means secure.

The SoH likely hopes that all members offering CEASE therapy will voluntarily comply with its position statement. Some may - especially if they have had few/no takers for CEASE - but some others? The SoH may well face dissent from certain members (including some mentioned here). The SoH if it wishes to be re-accredited in the future can not afford to indulge dissenters. It can not afford any delaying tactics, challenges to the position statement and its enforcement. If dissenters do not comply, the SoH will have to take disciplinary action. This will consume resources and potentially cost money - especially if lawyers become involved. If a member is expelled by the SoH, they do have a right of appeal. Again, this consumes resources and it is more likely that lawyers could become involved. It is worth pointing out that large numbers of complaints/disciplinary proceedings can 

The PSA are likely to take a keen interest in any disciplinary proceedings as are critics of homeopathy. If the SoH don't deal with things effectively, accreditation is at risk.

There is supposedly an agreement between the homeopathic trade associations that if a member is expelled from one, they can not join another. This would also have the effect of them no longer being listed on the Findahomeopath website (the value of a listing is moot). There are some other trade associations that have broader scope than just homeopathy that might admit them but not PSA accredited ones.

Dissenting members could simply resign and go join another trade association. Indeed, the Alliance of Registered Homeopaths (ARH) was originally formed by dissenters from the SoH.

Whatever happens, the SoH is faced with a loss of members with no real prospect of increasing membership. It is impossible to estimate numbers. The SoH may be forced to raise membership fees but as Mark Taylor said in his bullish statement about some members of the SoH -
They are often sole traders, struggling to make a living and don’t have the luxury or the budgets to travel and pay for corporate-style ‘networking’.
If this is true (and homeopaths are prone to exaggeration), such members are likely very sensitive to cost increases. The SoH might alternatively or additionally look to cut costs. This could include reducing staff costs. It might involve relocation.

As has been pointed out in numerous previous posts, the SoH are well aware of the illegality of lay homeopaths supplying unlicensed medicines. The "detox" remedies used in CEASE therapy are unlicensed medicines. The Medicines and Healthcare Product Regulatory Agency (MHRA) has the power to completely stop the supply of these remedies if it so wished. This would effectively kill CEASE therapy in the UK. The MHRA forbade the open advertising of these remedies some time ago. Other international medicines regulators have forbidden the supply of these remedies or are in the process of investigating them.

All potential UK suppliers have been written to pointing out the nature of CEASE therapy, the illegality of supply to UK lay homeopaths and the MHRA instruction not to advertise. Not that this communication has any legal force but it does place any UK supplier in an ethically difficult position - if they did not already know what the remedies were used for they now do and they will know that CEASE therapy is neglect and a safeguarding issue.

One key question is whether the SoH can do enough to be re-accredited next year? It's committed itself to doing a number of things in order to meet the conditions of this year's re-accreditation. Reading between the lines, re-accreditation may prove difficult if it fails to achieve those.

Reading between the lines, the re-accreditation of the SoH has been a learning experience for the PSA. It is likely that the business of CEASE therapy has brought the safeguarding risks associated with Complementary and Alternative Medicine (CAM) to their attention. What applies to CEASE therapy is also likely to apply to other practices of SoH members.

In essence, if the SoH wish to retain PSA accreditation in the future, they may well have to place more restrictions on what members can say and do. Whatever the SoH and its members might like to think, there is likely a de facto scope of practice for lay homeopathy. What that might look like would be better dealt with a separate post but it would likely result in the loss of even more members.

What applies to the SoH also applies to other accredited registers. Some registers such as the Complementary and Natural Healthcare Council and Federation of Holistic Therapists are just as vulnerable as the SoH.

UPDATE 01/06/2018
After a delay of a week, the SoH finally did publish a news item regarding CEASE therapy. It is unfortunate to say the least.
The Society has published a position statement on CEASE within the Patients section of the website. CEASE was developed in the Netherlands by the late Dr Tinus Smits and is a powerful homeopathic protocol for deeply treating and clearing toxicity in the body. 
Commenting, the Chief Executive of the Society, Mark Taylor, said ‘ this statement is the result of a long process of negotiation and debate with the Professional Standards Authority and involving a number of prominent CEASE practitioners. It contains nothing that is really new. Members may offer CEASE therapy providing they avoid making misleading claims or make recommendations that breach NHS Guidelines’.
The irony of the news item making a misleading claim may be lost on the SoH. The SoH have never been particularly good at public relations but Taylor's comment is indicative of a failure to grasp issues of competence and safeguarding. Why on earth would the SoH be involving those who offer CEASE therapy? They are the problem - they are the people who lack the competence to treat autistic children, advocate a bogus therapy and do not seem to grasp safeguarding issues. It's the sort of thing that the media could make a great deal out of.

It is assumed that the news item was timed to coincide with the email newsletter that the SoH sends members every Friday. What it says is unknown but it is of concern.

On the other hand, it seems like a few SoH members are dropping mention of CEASE therapy and/or autism. Of course, marketing claims are not necessarily indicative of the actual risks posed to children by a practitioner, but even so. Perhaps some members are more acutely aware of the potential impacts of negative publicity?