Wednesday, 20 December 2017

NHS Homeopathy #4 - Outcome of Consultation

Previous blogposts (here, here and here) have discussed the NHS England Items which should not be routinely prescribed in primary care: A Consultation on guidance for CCGs in some depth. Not only have they discussed that NHS England does not have the legal power to prevent GPs from prescribing homeopathic medicine, they also discussed how reporting of and reaction to the Consultation is often wildly wrong.

Responses to Consultation
The report of findings from the Consultation can be found here. It is a long document and most of it does not relate to homeopathy. The Consultation asked whether respondants agreed with two statements (as well as invititing further comment) -
  • Advise CCGs that prescribers in primary care should not initiate Homeopathy for any new patient
  • Advise CCGs to support prescribers in deprescribing Homeopathy in all patients and, where appropriate, ensure the availability of relevant services to facilitate this change
Of those that expressed an opinion to the first statement, only 46% agreed. With the second statement, only 50% agreed.




As the various homeopathy bodies mounted an astroturfing campaign, these figures must be taken with a pinch of salt. The clinician numbers look wrong to be begin with. It seems unlikely that there are circa 150 clinicians who support GP prescribing of homeopathic medicines. It could well be that lay homeopaths said they were "clinicians" in their response. Likewise, it could also be the case that clients of lay homeopaths have described themselves as "patients".Given that only 2440 items were prescribed in 2016 and that many would have been repeats, it is difficult to believe that 875 figure. If correct, it represents an incredible level of patient engagement.

There is further analysis but it merely confirms that supporters of homeopathy are more likely to be older and female. Nana medicine.

The verbatim comments quoted are in line with expectations. One CCG stated -
“These should be blacklisted to enable a consistent and equitable approach across the country on these medicines of very limited clinical value.”
The British Medical Association (BMA) stated -
[Homeopathy is] better dealt with by inclusion in the blacklist of drugs unavailable on the NHS.
So, some respondants are clearly aware of the limitations of NHS England's powers to prevent prescription.

Submissions #1 - Homeopathy Research Institute
The Homeopathic Research Institute (HRI) submitted this document. HRI is a charity set up by one Alex Tournier. One of the research "projects" it funds is the Water Research Laboratory strangely run by Alex Tournier. From the statement -

It is apparent from the list of member organisations provided (CD Appendix1, p.29) that there is not a single party within this working group with the relevant and necessary specialist knowledge and expertise to assess homeopathic medicines.
Again, the canard that somehow evaluation of the evidence for the efficacy needs specialist knowledge. This is not the case and has been dealt with here.

It is also clear that the HRI has a limited understanding of the NHS, ethics and economics. It also engages in whataboutism.

The HRI suggest that prescribing of homeopathic medicines could only be prescribed by "specialists". This is nonsensical given that i) homeopathy is not recognised as a speciality and ii) it would have to be done in secondary care, which would have to be commissioned by CCGs locally. The latter will be discussed in greater depth in a future post but these services no longer exist in England except at the Portland Centre of Integrative Medicine (PCIM) in Bristol and the Royal London Hospital for Integrated Medicine (RHLIM) and thus are not accessible to the majority of the population. It will not come as a surprise that Elizabeth Thompson, head of the PCIM, is a trustee of the HRI. Peter Fisher of the RHLIM sits on their "scientific" panel - they have a vested interest in this model. Although the costs of such provision are not precisely known, the Good Thinking Society (GTS) came up with some figures - comparing these with a previous post the comissioning of secondary care homeopathic services costs NHS England a lot more than GP prescribing. Rather than save money, the HRI are de facto suggesting more money should be spent.

The HRI makes some statements about the ethics of stopping GP prescribing of homeopathic medicines yet fails to tackle the thorny issue of the ethics of prescribing placebo.

  • It is only ethical to remove homeopathic medicines if an alternative treatment option is provided which gives similar or superior clinical benefits.
  • It is only economically justified to remove homeopathic medicines if the replacement treatment options cost the same or less than homeopathic prescriptions.
The problem is that given there is no evidence of efficacy beyond placebo for homeopathic medicines and it could be argued that prescribing almost anything else (including not prescribing anything) would be more effective. Given what is known about medicines costs and dispensing fees, many medicines cost NHS England a lot less than homeopathic ones.

The most bizarre statements regard "equality".

  • It is only legal if NHS E’s actions comply with the Equality Act 2010 (see below).
Which is followed by

4. Evidence that removing homeopathic medicines will not put NHS E in breach of the Equality Act 2010 (a risk identified in Appendix 3, CD p.33). This requires an assessment of patients currently using homeopathy in terms of ‘age, disability, gender reassignment, race, religion or belief, sex, sexual orientation, marriage and civil partnership, pregnancy and maternity’.  
But it has to a large degree. NHS England did conduct a health equality assessment which is sufficient to satisfy best practice guidance for public consultation. The responses to Consultation also provided additional data on patients, putting aside the question of astroturfing. As discussed previously, the only major potential impact is on patients who are exempt from prescription charges and then only those who are economically deprived - eg many pensioners have a decent income and could easily afford the prescription charge. Note no mention of this in the above statement.

From practical experience such an assessment would be difficult, time consuming and expensive. For one thing, GP prescribing data held by NHS England does not contain unique patient identifiers, which would be required to link to other data held elsewhere. It is very possible that the results of any such analysis would not be to the liking of supporters of homeopathy. Nana medicine for one thing.

It is worth pointing out that the British Homeopathic Association (BHA) did try this approach when applying for a judicial review in the past and it failed.

One key message from the HRI submission is it that it fails to understand the concept that its extraordinary claims require extraordinary evidence. It attempts to hold NHS England to a standard that the HRI falls well short of.

Submissions #2 - Society of Homeopaths
The submission from the Society of Homeopaths (SoH) cites a number of cherry-picked studies. The Nightingale Collaboration examined some of these here although they were responding to a SoH intiative to help individual members promote their businesses.

They also mention "patient choice" -

Homeopathy has been part of the NHS service in the UK for over 60 years and is a popular choice for many patients and parents. In 2013 homeopathy was the second most popular complementary therapy in the UK (Watson, Leala KPosadzki, Alotaibi, and Ernst 2013). Orthodox medicine does not meet the needs of every patient (Franzel et al. 2013; Posadzki et al. 2013).The inclusion of homeopathy extends the range of patient choice and supported self-care within the NHS. 
UK NHS patients come from many cultures and ethnic origins, including those from countries such as India, France and Switzerland where homeopathy is widely used as part of the primary healthcare system. Recommending the de-prescribing of homeopathy on the NHS cannot claim to be in the interests of equality and diversity, and certainly not in the interest of patient choice. 
The French are also very keen on suppository forms of some analgesics. The suggestion that homeopathy is a "popular" choice is largely unfounded. The choice between medicine and placebo is not a choice though. And the NHS is more utilitarian in nature than being driven by notions of "patient choice" which is relatively recent concept - arguably first rose in importance under Tony Blair, although some of the nonsense about "internal markets" popped up earlier. Whilst it is difficult to swallow for many, what most people want is decent local provision of services at a high standard rather than "choice".

Submissions #3 - British Homeopathic Association
Given that the British Homeopathic Association have been arguably the most aggressive group in terms of challenging the NHS England consultation, it is strange that their grounds for challenge aren't exactly transparent. It is known that they made a submission but it doesn't seem to appear anywhere on the internet. It is known that it contained "evidence".


The Special Pharmacy Service was asked to review the evidence the BHA submitted. The results of that review can be found here.

Outcome of Consultation
On 30/11/2017, the NHS England board met. The agenda can be found here. As can be seen, it considered other matters than just the Consultation. The outcome can be found in this document. The most important part is this -
38. Having considered the wide range of responses to our consultation, and taking into account of the findings of the SPS review, the clinical working group was of the view that the scientific review of the evidence should be preferred to the anecdotal evidence from patients and, notwithstanding what we perceive to be marginal cost issues, that the initial recommendations should stand.
The intial recommendations being -
  • That prescribers in primary care should not initiate Homeopathy for any new patient
  • To support prescribers in deprescribing Homeopathy in all patients
Then -
43.In relation to a number of drugs, the consultation feedback included requests that the particular drug should be formally placed on the 'blacklist'. This is not a matter for NHS England, but rather one for the Secretary of State to consider. Subject to the Board’s agreement to the recommendations in this report, it is proposed that NHS England recommends that the Secretary of State formally consider blacklisting the following drugs:
  • Co-proxamol
  • Glucosamine and Chondroitin
  • Herbal Treatments
  • Homeopathy
  • Lutein and Antioxidants
  • Omega-3 Fatty Acid Compounds
  • Rubefacients (excluding topical NSAIDS) 
44.If the Secretary of State decides to proceed with any such recommendation, there will be a further formal consultation on the proposals.
This press release shows that the NHS England Board approved these recommendations.

Reaction
Mainstream media reaction was quite muted and reporting quite accurate although some did get confused between NHS England recommending products be blacklisted and them actually being blacklisted. The only major concerns raised in reporting was that some would be unable to afford OTC products that were previously prescribed for free but this applies to all OTC products, not just homeopathic medicines.

As might be expected supporters of homeopathy were up in arms. With one curious exception from the Faculty of Homeopathy
Although disappointing, this decision was not unexpected. The gradual withdrawal by CCG’s of funding for homeopathy has resulted in patients finding it increasingly difficult in recent years to access the therapy through the health service. And while removing homeopathy from NHS prescribing is a blow to morale, its actual impact will be negligible on the majority of Faculty members. This is because most members are in private practice, many of whom report an increase in the number of patients they are seeing. Evidence from various market research surveys support what Faculty members are experiencing, with forecasts showing an increase in sales of homeopathic medicines in the coming years. It could also be argued that the slow demise of NHS homeopathy removes the “waste of valuable NHS resources” argument frequently used by our opponents. This is not to say that we are abandoning our support for NHS homeopathy, and I can assure all members who work at the Royal London Hospital for Integrated Medicine and the Portland Centre for Integrative Medicine in Bristol, the Faculty remains committed to defending the valuable services they provide.
The statement goes onto say -
Nevertheless, it would be remiss of me as chief executive and of the Faculty council if we were not to take a pragmatic view and make plans for a future where possibly homeopathy is no longer available on the NHS. To this end we a have already investigated opportunities to work more closely with other organisations promoting the use of complementary therapies as part of an integrative approach to healthcare. Furthermore, while we are beset with challenges here in the UK, homeopathy receives a less hostile reception in other parts of the world. Therefore, the Faculty is looking to build on its enthusiastic international membership, where we hope to see our global influence in matters relating to the training and practice of homeopathy increase. 
An example of leadership rarely seen in the world of homeopathy. 

As discussed in previous posts, the guidance is not binding and only the Department of Health has the power to blacklist medicines and the outcome of the consultation makes this very clear. This was something that many got very wrong but no mention is made of this.

The Society of Homeopaths response can be found here and it still gets things wrong.
Mark Taylor, Chief Executive of the Society of Homeopaths, said: “Our original argument still stands: the consultation process was flawed and it seems unjust for NHS England to press ahead until the case for a judicial review has been heard.”
The British Homeopathy Association response is here. It contains the following statement -
Instead of listening to patients who have benefited from the therapy, or to the doctors who have treated them, NHS England chooses to base its decision on the discredited House of Commons Science and Technology Committee’s report from 2010 and the 2015 study by Australia’s National Health and Medical Research Council, which is so flawed it is currently being investigated by the Commonwealth Ombudsman, facts NHS England conveniently failed to mention in the reams of documentation it produced for its board meeting.
The STC report is not discredited. The story behind the statement that the NHMRC is under investigation is very murky as there is there no sign of any submission to the Ombudsman. Apparently, it was prepared by the HRI.
The BHA is still going ahead with its legal challenge calling for a judicial review of NHS England’s consultation.
Which is strange given that NHS England has very firmly put the ball into the DH's court regarding blacklisting. Even assuming that leave was granted for judicial review, and even assuming that a judgment was made to overturn the findings of the Consultation, surely the BHA et al should be more concerned by what the DH intend to do next and whether they will consult on the blacklisting of homeopathy?

Next Steps
What is likely to happen now is that NHS England will start to put together the actual guidance. It is unclear what form it will take but it has to -
  1. Explain very clearly to GPs why they should not prescribe homeopathic medicines in terms that even Anthroposophists understand
  2. Provide GPs with the necessary supporting information to be used to convince patients that they do not need homeopathic medicines - even Nana.
Whether the handful of GPs who routinely prescribe homeopathic medicines will comply with the guidance is moot although the existence of the OpenPrescribing tool makes non-compliance highly visible to the public. It is known that various persons/organisation do use the tool to monitor GP prescribing even within the NHS.

Blacklisting
The willingness of the Department of Health (DH) to blacklist homeopathic medicines is not known. That NHS England recommends that they do is difficult to ignore. At the very least, the DH need to consider the matter and in time issue a statement. Historically, the DH and in particular Secretary of State for Health Jeremy Hunt have given very mixed messages - phrases like "patient choice" and "clinical freedom" are said along side the need for "evidence based practice".

The more cynical will point to a more "hands off" approach by the DH to bodies under their control such as NHS England as essentially an attempt to distance the current Government from politically unpalatable realities, shifting blame. This is a question beyond the scope of this blog.

However, NHS England asking the DH to do something it wants but lacks the legal power to do is somewhat different from the usual political arguments over funding and closures of services. That the DH has devolved many powers to NHS England is one thing but that it has not devolved the power to control GP prescribing is remiss. 

Although the NHS England states that if the Secretary of State wishes to proceed with blacklisting a further consultation would be required, this is not strictly true. It is good practice but not a legal requirement. Of course, the decision to act without consultation could be subject to judicial review but the irony is that the decision not to act at all could also be subject to judicial review and much more likely to suceed. The Good Thinking Society have in the past stated that they would seek judicial review if the DH did not act but called off the action. It could be argued that given the low value of homeopathic medicines now prescribed on the NHS, it is an expensive route to nowhere.

The DH powers to blacklist derive from the National Health Service Act 2006 et al and most importantly the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004 and any following Regulations. Notionally, the Regulations should be updated on a regular basis but the last was in 2014.

It is important to note that the Regulations are a Statutory Instrument - secondary legislation that does not need to be approved by a vote in Parliament. A Statutory Instrument is subject to Parliamentary control either by a negative resolution procedure or affirmative resolution procedure. The former requires that the instrument is published and will come into law unless resolution is passed to annul the instrument but this first requires that an MP raises a motion to annul. However, unless a large number of MPs sign the motion, there is no guarantee that a debate will be granted and a vote made. The latter is much rarer and does require that the Government raises a motion itself.

In both cases, it is extremely rare for instruments not to make their way into law. The last time this happened was in 2000.

If such a Statutory Instrument did become law then there is still the possibility of legal challenge via the Supreme Court which has the power to overturn secondary legislation if found ultra vires but technically, this would not be the case as powers to blacklist well within the remit of the Act. However, the Supreme Court also has the power to make a declaration of incompatibility with Human Rights legislation. Other courts have the power to do this too but they often refer upwards on matters of legislation. It would be difficult to argue for a human right infringement.

Beyond that, an appeal to the European Court of Justice would be possible but difficult, slow and very unlikely to suceed - it would be hard to make a cases that blacklisting infringes EU law. Likewise, an appeal to the European Court of Human Rights would be difficult to make.


UPDATE
The British Homeopathic Association submission to consultation recently appeared on their website. As might be expected, it has some problems. But to begin with -
The British Homeopathic Association (BHA) is a charity which was founded in 1902. Its overall objective is to ensure that homeopathy is available to all by means of (amongst other things) ensuring patients have access to homeopathy. The BHA feels this consultation as put forward by NHS England is fundamentally flawed for reasons set out in detail in our legal correspondence with NHS England. The consultation has among other things, not taken in to proper consideration the evidence for homeopathy’s use nor considered the negative impact on patients and the NHS if it is removed from prescribing.
The "legal correspondence" has not been seen. What it consists of is unknown.
The BHA also participated in the NHS England open meeting on the 5th of September in London where detailed feedback and information was shared with NHS England about our views about the consultation, the value of homeopathy and evidence to back its use. We were given assurances that this feedback will be reviewed and captured in detail and fed into the consultation for consideration.
Open meetings were part of the consultation. The BHA attended one and shared their "views". Assurances of review do not guarantee a particular outcome.
We have submitted our consultation response at this late stage of the consultation due to the fact that we have been awaiting substantive feedback from NHS England regarding concerns we have raised legally about the consultation process (which has not been forthcoming) and following an engagement meeting with NHS England which was held on 18th of October. At this meeting information and evidence was shared with the NHS England team. We were given assurances what was shared both in print and verbally would be considered. NHS England staff also explained what information NHS England would find useful in reviewing homeopathy, enabling us to better prepare our response. 
Again, stress the point about "assurances". It is worth pointing out that any legal correspondance between the BHA and NHS England as well as the record of any meetings are amenable to Freedom of Information Act (FOIA) requests. The exact nature of the BHA's legal objections is still not clear. It is hoped that FOIA responses from NHS England will makes this clear. At the time of writing, a date has not been set for the BHA's application for judicial review. Their legal arguments will need to set out then.

The rest of the submission is as poor as might be expected. It makes a great deal out of a patient survey conducted by the long defunct Bristol Homeopathic Hospital. There is some very questionable analysis of costs that are essentially whataboutism. There are appeals to popularity based on numbers of respondants to the flawed petition that the BHA set up. There are quotes from and links to the Homeopathy Research Institute. But...
In addition, the NHS England proposals for homeopathy and herbal treatments are inclusive of the whole therapy, not medicine specific. It is not Arnica 30c for homeopathy or St John’s Wort in herbal treatments being proposed for removal it is the whole of the medicine type. The equivalent would be all pain relievers or all antidepressants being proposed for removal. This is not equitable, appropriate and is harmful to the patients and clinician that depend on homeopathy, given no alternatives to treatment have been identified. 
This argument needs to be understood in the context that homeopathy is promoted as a whole. It is also the case that supporters of homeopathy often seem to believe that if a trial of a particular homeopathic medicine showed efficacy beyond placebo that validates the whole of homeopathy. 

There is also a lengthy appendix - an article by Dr Peter Fisher.

1 comment:

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