Tuesday, 24 October 2017

More on CEASE Therapy

The nature of CEASE Therapy was discussed in a previous post. There was also a post listing some UK practitioners and also another post listing Irish practitioners.

Whilst the latter two posts were not intended as "name and shame", it is disappointing to note that none of the mentioned practitioners seem to have amended their claims. Of course, it is entirely possible that they are unaware of these posts.

This will be a short post for this blog.

This website was analysed in quite some depth in the first linked post, so it makes little point repeating here. However, it is important to note that linkage to this website does have repercussions in the degree to which a practitioner's website is in compliance with their trade association's Codes of Ethics, advertising regulation, consumer protection law and even medicines regulation.

The Stichting Reclame Code (SRC) is the Dutch Advertising regulation, very much like the UK ASA. It recently published a ruling against the website - unfortunately in Dutch but in summary -
The complaint refers to a website on which the CEASE-therapy is proposed as a "very effective way to treat autism with amazing results". This is explained by saying that the CEASE-therapy ‘detoxes’ all causes of autism with a homeopathic prepared substance. On the website, there’s a possibility to order books about the CEASE-therapy and to take a course about this therapy. Also the nearest “Cease therapist” is shown. Because of this all, the website has to be considered as an advertisement for the CEASE-therapy and falls therefore within the meaning of article 1 of the Dutch Advertising Code (NRC). Not relevant is that, according to defendant, there is no financial or commercial interest in the website nor that the website is only meant as an opinion about the CEASE-therapy.

Defendant has not substantiated that the CEASE-therapy is an effective way to treat autism and that the CEASE-therapy can treat autism with "amazing results". The average consumer will perceive this as 'Healing'. Therefore, defendant is falsely claiming that the product may cure illnesses, ailments or malformations as referred to number 16 of annex 1 to article 8.5 NRC.

Further, the defendant didn’t substantiate that autism can be caused by vaccinations of children or their parents. As a causal link between vaccination and autism is not proven, the advertisement appeals without justifiable reasons to feelings of anxiety as referred to in article 6 NRC.
The SRC has instructed the owner of the website to make amendments to comply with the Dutch advertising code. Amendments have yet to be made. If they are not, the SRC can contact the Autoriteit Consument & Markt (ACM) - which has the legal powers to enforce consumer protection legislation.

It's not clear how the website can comply. The links promoting the book, training courses and the practitioner directory would have certainly have to be removed but even then much of the content could well be considered advertisement.

It's problematic enough for UK and Irish practitioners to link to the CEASE therapy website but some have quite detailed entries on the practitioner lists which would place them in breach of regulations etc even if their own websites are compliant.

Given that in several jurisdictions it has been established that promotion of CEASE therapy is question able to say the least, the practitioner lists do potentially provide a list of people to be reported to regulators, trade associations, etc. Assuming anyone was motivated to do that.

As seen in previous posts, promotion of CEASE therapy on a website is often associated with other non-compliance. Any reporting of CEASE therapy could well result in scrutiny that would bring that to light.

Thursday, 12 October 2017

Letter to Twitter

Twitter, Inc.
c/o Trust & Safety – Legal Policy
1355 Market Street Suite 900
San Francisco, CA 94103

To whom it may concern,

Violations of (Indian) The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and The Homoeopathic Practitioners - (Professional Conduct, Etiquette & Code of Ethics) Regulations 1982

It has come to my attention that there are many Indian homeopaths and homeopathic medicines manufacturers who use Twitter as a form of promotion for their business. Some examples would include -

  • @HomeoPositive - Positive Homeopathy
  • @homeosure - Homeosure
  • @drcarehomeopath - Dr. Care Homeopathy
  • @drsantoshhealt2 - dr.SantoshHealthcare
  • @HomoeopathyDr - Dr. Naik Homoeopathy
  • @drrajneesh - Dr. Rajneesh Sharma
  • @Baksons - Bakson's Homoeopathy
  • @ShreeHomoeo - Shree Homoeo
  • @homeohealer - Dr.Ramesh Bhardwaj

There are many more of them. It is clear that all of them are in breach of Indian legislation and regulations. It is also likely that there are in breach of Twitter standards in that they are using the platform for illegal advertising. In some cases, it would appear that Twitter is in breach of Indian legislation by providing a platform.

Homoeopathic Practitioners Regulations
The Homoeopathic Practitioners Regulations (http://www.cchindia.com/homoeopathic-practitioners-professional-conduct-etiquette-code-of-ethics-regulations-1982-as-amended-upto-july-2014/) effectively bar all forms of advertising beyond simple listings if changes to address, etc, occur. It also prohibits publication of case details outside of specialist media. To quote section 6.

  1. Advertising Solicitation of patients directly or indirectly by a practitioner of Homoeopathy either personally or by advertisement in the newspapers, by placards or by the distribution of circular cards or handbills is unethical. A practitioner of Homoeopathy shall not make use of, or permit others to make use of, him or his name as a subject of any form or manner of advertising or publicity through lay channels which shall be of such a character as to invite attention to him or to his professional position or skill or as would ordinarily result in his self-aggrandisement provided that a practitioner of Homoeopathy is permitted formal announcement in press about the following matters, namely :-
i) the starting of his practice;
ii) change of the type of practice;
iii) change of address;
iv) temporary absence from duty;.
v) resumption of practice
vi) succeeding to another’s practice.

  1. He shall further not advertise himself directly or indirectly through price lists or publicity materials of manufacturing firms or traders with whom he may be connected in any capacity, nor shall he publish cases, operations or letters of thanks from patients in non-professional newspapers or journals provided it shall be permissible for him to publish his name in connection with a prospectus or a director’s or a technical expert’s report
Additionally, the Regulations mention the need to comply with legislation.

Physician to obey law and regulation:-

A physician, –

  1. shall not act contrary to the laws regulating the practice of Homoeopathy;
  2. shall not assist others to disobey the law regulating the practice of Homoeopathy;
  3. shall act in aid of the  enforcement of sanitary laws and regulations in the interest of public health;
  4. shall comply with the  provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940), Drugs and Cosmetics Rules, 1945; the Pharmacy Act, 1948 (8 of 1948); the Narcotic Drugs and Psychotropic Substances Act 1985 (61 of 1985); the Medical Termination of Pregnancy Act, 1971 (34 of 1971), the Transplantation of Human Organ Act, 1994 (42 of 1994); the Persons with Disabilities (Equal Opportunity and Full Participation) Act, 1995 (1 of 1996) and Biomedical Waste (Management and Handling) Rules, 1998 and such other related Acts, Rules, of the Central Government or the State Government  or the Local Administrative bodies relating to protection and promotion of public health.

The Central Council for Homeopathy is the statutory body responsible for enforcement of these regulations. However, it has devolved them to State level bodies.

Drugs and Magical Remedies Act
Although the Regulations do not specifically mention it, it is clear that compliance with the Act (http://lawmin.nic.in/ld/P-ACT/1954/A1954-21.pdf) is a requirement.

This is arguably the most important piece of legislation covering advertising of homeopathic medicines as it places absolute prohibition on advertising medicines for certain diseases.

3. Prohibition of Advertisement of Certain Drugs for Treatment of Certain Diseases and Disorders.–
Subject to the provisions of this Act, no person shall take any part in the publication of any advertisement referring to any drug in terms which suggest or are calculated to lead to the use of that drug for –  
a) the procurement of miscarriage in women or prevention of conception in women; or  
b) the maintenance or improvement of the capacity of human beings for sexual pleasure; or
c) the correction of menstrual disorder in women; or  
d) the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule, or any other disease, disorder or condition (by whatsoever name called) which may be specified in the rules made under this Act:  
Provided that no such rule shall be made except,–
(i) in respect of any disease, disorder or condition which requires timely treatment in consultation with a registered medical practitioner or for which there are normally no accepted remedies, and  
(ii) after consultation with the Drugs Technical Advisory Board constituted under the Drugs and Cosmetics Act, 1940 (23 of 1940) and, if the Central Government considers necessary, with such other persons having special knowledge or practical experience in respect of Ayurvedic or Unani systems of medicines as that Government deems fit.

The Schedule lists the following conditions -

1. Appendicitis
2. Arteriosclerosis
3. Blindness
4. Blood poisoning
5. Bright’s disease
6. Cancer
7. Cataract
8. Deafness
9. Diabetes
10. Diseases and Disorders of brain
11. Diseases and Disorders of the optical system  
12. Diseases and Disorders of the uterus  
13. Disorders of menstrual flow  
14. Disorders of the nervous system
15. Disorders of the prostatic gland
16. Dropsy
17. Epilepsy
18. Female diseases (in general)
19. Fevers (in general)  
20. Fits
21. Form and structure of the female bust
22. Gall stones, kidney stones and bladder stones  
23. Gangrene
24. Glaucoma
25. Goitre
26. Heart diseases
27. High/Low Blood Pressure
28. Hydrocele
29. Hysteria
30. Infantile paralysis
31. Insanity
32. Leprosy
33. Leucoderma
34. Lockjaw
35. Locomotor ataxia
36. Lupus
37. Nervous debility
38. Obesity
39. Paralysis
40. Plague
41. Pleurisy
42. Pneumonia
43. Rheumatism
44. Ruptures
45. Sexual impotence
46. Smallpox
47. Stature of persons
48. Sterility in women
49. Trachoma
50. Tuberculosis
51. Tumours
52. Typhoid fever
53. Ulcers of the gastro-intestinal tract
54. Venereal diseases, including syphilis, gonorrhoea, soft chancre, venereal granuloma and lympho granuloma.

Some of the terms have very broad scope and potentially cover many different conditions/diseases. Asthma and AIDS were added at a later date.

“Any drug” must be understood in more broad terms than “any specific drug”. In the context of homeopathy, it is the claim to treat a condition with homeopathic medicines.

4. Prohibition of Misleading Advertisements Relating to Drugs.– Subject to the provisions of this Act, no person shall take any part in the publication of any advertisement relating to a drug if the advertisement contains any matter which a) directly or indirectly gives a false impression regarding the true character of the drug; or b) makes a false claim for the drug; or c) is otherwise false or misleading in any material particular.

Twitter, by publishing what is advertisments in the form of tweets would be in breach.

6. Prohibition of Import into, and Export from, India of Certain Advertisements.– No person shall import into, or export from, the territories to which this Act extends any document containing an advertisement of the nature referred to in section 3, or section 4, or section 5, and any documents containing any such advertisement shall be deemed to be goods of which the import or export has been prohibited under section 19 of the Sea Customs Act, 1878 (8 of 1878) and all the provisions of that Act shall have effect accordingly, except that section 183 thereof shall have effect as if for the word ‘shall’ therein the word ‘may’ were substituted.

Whilst this was written before the advent of the internet etc, Tweets, Twitter profiles and linked-to webpages could be considered “documents” in that they contain text. The uploading/creation of such “documents” could be considered export if the platform is based outside of India and/or the “documents” can be seen outside of India.

Twitter Terms
As Twitter makes clear -

  • Unlawful use: You may not use our service for any unlawful purposes or in furtherance of illegal activities. International users agree to comply with all local laws regarding online conduct and acceptable content.
As both the Regulations and the Act place prohibitions on promotion by Indian homeopaths, use of Twitter, except in very limited ways, would place them in breach of this.

Suggested Actions
Twitter could very easily remove offending tweets, remove links from profiles of Indian homeopaths and Indian vendors of homeopathic medicines. Twitter could also suspend accounts until the users are compliant with Twitter’s terms and conditions of use. Detecting violations of T&Cs is not difficult and suspect tweets and accounts could be easily identified.

Twitter would do well to engage with the Advertising Standards Council of India (ASCI).

It is also important to note that reporting breaches of local law regarding illegal marketing claims is almost impossible via Twitter’s tweet reporting system.

Tuesday, 3 October 2017

NHS Homeopathy #1 - GP Prescribing

There have been a number of stories about proposed cuts to NHS homeopathy in England. Not just in specialist media but also in mainstream national media. There has also been considerable interest on social media.

One of common theme of both is that the reporting or reaction is often substantially wrong in detail or that key details are missing. This is not surprising given the complex structure of the NHS and its complex processes.

However, the inaccuracies of these reports/reactions pales beside how wrong supporters of homeopathy can be...

"Save NHS Homeopathy and Herbal Medicines!!!"
The 4Homeopathy group have a poster that can be found here although other branded versions appear on the British Homeopathic Association website, Friends Royal London Hospital for Integrated Medicine website and is linked to by many other websites, social media posts and email newsletters.

It states -

The NHS is deep into a consultation aiming to abolish prescriptions of homeopathic and herbal medicines
Act now before it affects your choice of all complimentary and alternative medicines
The consultation ends on the 21st October. Act before it's too late to save Homeopathy and Complementary Medicine on your NHS
1. Complete the consultation document
2. Sign the petition
3. Write to your MP
4. Help spread the word: share this with your friends
CAM can reduce NHS prescribing costs of £9.2bn
70% of patients reported positive health changes following homeopathic treatment
Bullying tactics a small group of activists is campaigning to deprive you of choice in NHS treatments 
The thin end of the wedge Once NHS services disappear they're gone for good
Homeopathy gives you a safe and natural choice 

There is much that is incorrect here.

The consultation is called Items which should not be routinely prescribed in primary care: A Consultation on guidance for CCGs. It is being carried out by NHS England. Scotland and Wales have their own NHS services. In Northern Ireland, social care and healthcare are integrated, but that doesn't matter. What matters is that this is NHS England.

The consultation's focus is very broad. To describe it as "aiming to abolish prescriptions of homeopathic and herbal medicines" is misleading to say the least. It is essentially about reducing NHS England prescribing costs and homeopathic and herbal medicines represent a tiny proportion of the potential savings.
Often patients are receiving medicines which have been proven to be ineffective or in some cases dangerous, for which there are other more effective, safer and/or cheaper alternatives.
Cheaper means cheaper to the NHS and it is not just about providing an alternative medicine via the NHS, it can be advising the patient to purchase the medicine over-the-counter. Indeed, this can often lead to a cost saving for the patient.

The title of the consultation includes the word "guidance". NHS England does not have the power to prevent the prescribing of any medicines in the consultation. The power to blacklist medicines resides with the Department of Health (DH) via the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004. A list of prohibited products can be found in Schedule 1 of the Regulations but is periodically updated by amendments. At the time of writing, no homeopathic medicine was on that list. This will be discussed later.

Clinical Commissioning Groups (CCGs) are effectively a local tier below NHS England. CCGs have guidelines on medicines that should only be prescribed by GPs in certain circumstances or not all. The term "locally agreed formulary" or similiar is often used. An example can be found here. And these formularies cover much of the same ground as the Consultation.

Note that again, CCGs have no power to enforce what are essentially guidelines. As the next post will show, in the case of homeopathic medicines, many CCGs have had zero prescribing for years and in reality the majority of the prescriptions are written by a handful of GPs.

CAM can reduce prescription costs
There is no compelling evidence of this despite literature. Although some supporters of homeopathy will cite the French EPI-3 cohort studies, the studies only make mention of lower usuage of certain other classes of drugs by GPs qualified in homeopathy vs those not. This does not translate to lower costs. And France is not England.

In England, the standard prescription charge is now £8.60. The linked to article explains some are exempt from the charge. Prescription charges do generate income for NHS England, but the cost implications are complicated. What is simple to understand that many patients, if drug costs less than the prescription charge and it available over the counter, a GP will almost always advise a patient to do this.

A previous post explains the complexities of medicines regulations but in short, from the perspective of this post, there are two sorts of homeopathic medicines - registered ones that can be bought over the counter in many outlets and unregistered ones which can only be legally obtained from specialist pharmacies/manufacturers (and are treated as "specials").

The registered products are those most often used (unsurprisingly) and their costs vary but the majority of them seem to be around the £5-6 range. Certainly less than the prescription charge. So clearly, for many it would make economic sense to buy them themselves. This is also true for the unregistered products although generally a mail order will need to place and there maybe a delivery cost but even so.

The actual cost of prescribing a medicine to NHS England is complicated - this is a simplified explanation. It is important to understand that Community Pharmacies are not part of NHS England. They are private businesses contracted to fulfill NHS prescriptions (and sometimes other NHS services). They may process the prescription charge but it goes to NHS England. NHS England pays community pharmacies for a notional of an item of medicine determined by the Drug Tarrif. If the medicine is not in Tarrif (homeopathic medicines aren't), the pharmacy is effectively paid the cost of the medicine (but the process is more complicated). A browse of the Tarrif will reveal that many medicines cost less than homeopathic medicines do (see here).

The Tarrif also determines the fees paid to pharmacies for dispensing the medicines. This is currently £1.25. However, whilst this fee would be payable on registered homeopathic medicines, it would not on unregistered. They would attract a "specials" fee of £20.00. The proportion of registered/unregistered products is not currently known but it is certainly the case that unregistered homeopathic medicines are de facto more expensive than many medicines. 

Reported Positive Health Changes
The 70% figure comes from an observational study Homeopathic Treatment for Chronic Disease: A 6-Year, University-Hospital Outpatient Observational Study conducted at the Bristol Homeopathic Hospital (which no longer exists and actually an outpatient clinic not a "hospital" in itself) from 2003. Unfortunately the study is behind a paywall.

Bullying Tactics
This would appear to relate the Good Thinking Society. It is true that they have lobbied against NHS homeopathy but to describe that as "bullying" implies that NHS bodies are likely to be moved by lobby groups. Homeopathy supporters have discovered this not to be the case.

Thin End of the Wedge
This is a meaningless statement.

The misreprestation of the nature of the Consultation and suggesting NHS England could implement a ban is either scaremongering or represents a failure to understand how the NHS works. Neither is exactly good PR for UK homeopathy supporters.

The unevidenced claim that homeopathy etc could contribute to a reduction in NHS England prescribing costs is not good PR either. Again, this seems to represent a failure to understand how the NHS works.

The next post will analyse some of the prescription data.

Government has responded to the petition that was started by supporters of homeopathy. It's very clear that the details of the petition are wrong and the the government's response is predictable - 

It is for local NHS organisations to decide on the commissioning and funding of these healthcare treatments. NHS England’s consultation on low value prescription items includes homeopathic treatments.

Information from NHS England (NHSE) shows that in 2015, the cost for all prescriptions dispensed in primary care, not including any dispensing costs or fees, was £9.27 billion, a 4.7% increase on the previous year. Due to the increasing cost, NHSE is leading a review of medicines which can be considered as being of low clinical value and develop new guidance for Clinical Commissioning Groups (CCGs).

On 21 July, NHSE launched a three month consultation on the draft guidance on low value prescription items which is based on the latest clinical evidence, including that from the National Institute of Health and Care Excellence (NICE). Careful consideration has been given to ensure that particular groups of people are not disproportionately affected, and that principles of best practice on clinical prescribing are adhered to.

The commissioning guidance, upon which NHSE is consulting, will be addressed to CCGs to support them to fulfil their duties around the appropriate use of prescribing resources. This will need to be taken into account by CCGs in adopting or amending their own local guidance to their clinicians in primary care.

The aim of this consultation is to provide individuals with information about the proposed national guidance and to seek people’s views about the proposals. NHSE welcomes the views of the public, patients, clinicians, commissioners and providers through this consultation process to help inform the final guidance. The consultation ends on 21 October. Links to the consultation can be found here:
https://www.england.nhs.uk/2017/07/medicine-consultation/ and
It is the responsibility of local NHS organisations to make decisions on the commissioning and funding of any healthcare treatments for NHS patients, such as homeopathy, taking account of issues to do with safety, clinical and cost-effectiveness and the availability of suitably qualified and regulated practitioners.

Complementary and alternative medicine (CAMs) treatments can, in principle, feature in a range of services offered by local NHS organisations. A treating clinician would take into account an individual’s circumstances and medical history in deciding what would be the most appropriate treatment for their condition. CCGs will have specific policies on the commissioning and funding of CAMs, and may have also developed local policies on priorities with regards to the funding of treatments. A GP would have to work within such policies in providing any treatments on the NHS. 
The Department of Health supports an approach to evidence-based prescribing which does not support the commissioning of services which are not clinically and cost effective. We are not aware of any evidence that demonstrates the therapeutic effectiveness of homeopathic products. The National Institute for Health and Care Excellence (NICE) does not currently recommend that homeopathy should be used in the treatment of any health condition, whilst primary care prescribing data shows that there has been a significant decline in the prescribing of homeopathic products over the last 10 years. Furthermore, a good number of NHS organisations are reviewing their funding of homeopathic treatments and some have already stopped funding such treatment altogether.

As mentioned before, CCGs not have the power to enforce local policies on GPs. The Department of Health do have the power to black list products but seem not to want to. One cynical interpretation is that the DH want local CCGs to take the blame for unpopular decision whilst Government sits on its hands. It has been suggested that this may be due to politicians' erroneous perception that policy on CAM is important to many voters. In reality, this not the case as the low response rate to the petition shows.