Saturday, 11 March 2017

Regulation of Veterinary Homeopathy #2

This post is about the ethics and some of the practicalities of veterinary homeopathy. It also needs with animal welfare issues and some specific legislation that relates animal husbandry. Some readers may have difficulties with some of the news stories linked to that involve neglect.

Animals are not Humans
This may seem rather obvious but is worth stating the obvious at times. The ethics of treating animals are different to those of treating humans - especially consenting adults. The law is different and perhaps most importantly, if homeopathy works on animals that absolutely proves that isn't placebo, surely?

The law is very clear. A full discussion of the ethics of the treating animals would be far too lengthy to include here but, perhaps, the fact that animals can not legally consent to treatment places an onus on owners and veterinary surgeons to act in the best interests of an animal. Owners do not always act in the best interests of their animals which places a duty on veterinary surgeons to at least suggest that owners should not act in a certain way, not be complicit in the owner's action. A vet going along with an owner's preference for homeopathic treatment could be seen as complicit.

The arguments against homeopathy in general were discussed in a previous post. All of these still apply and if anything, the low numbers of trials of veterinary homeopathy and their even poorer quality makes any claim of efficacy beyond placebo less credible. But a key part of homeopathy is the detailed consultation process. This would be impossible with an animal. Veterinary homeopathy is thus even more implausible that its use in humans.

Legislation covering Veterinary Surgeons
As mentioned in the previous post,  the Veterinary Surgeons Act 1966 is the most important piece of legislation. To quote from Act 1966 -
An Act to make fresh provision for the management of the veterinary profession, for the registration of veterinary surgeons and veterinary practitioners, for regulating their professional education and professional conduct and for cancelling or suspending registration in cases of misconduct; and for connected purposes.
The Act gives various powers to the Royal College of Veterinary Surgeons (RCVS) including setting standards for professional conduct and enforcing them. The RCVS is a statutory regulator.

  1. Code of Professional Conduct for Veterinary Surgeons
  2. The RVCS provide their code here along with supporting guidance. The Code is not a lengthy document. 

Professional responsibilities
Veterinary surgeons have professional responsibilities in the following areas:

1. Veterinary surgeons and animals
1.1 Veterinary surgeons must make animal health and welfare their first consideration when attending to animals. 
1.2 Veterinary surgeons must keep within their own area of competence and refer cases responsibly. 
1.3 Veterinary surgeons must provide veterinary care that is appropriate and adequate. 
1.4 Veterinary surgeons in practice must take steps to provide 24-hour emergency first aid and pain relief to animals according to their skills and the specific situation. 
1.5 Veterinary surgeons who prescribe, supply and administer medicines must do so responsibly 
1.6 Veterinary surgeons must communicate with each other to ensure the health and welfare of the animal or group of animals. 
1.7 Veterinary surgeons must ensure that clinical governance forms part of their professional activities. 
2. Veterinary surgeons and clients 
2.1 Veterinary surgeons must be open and honest with clients and respect their needs and requirements. 
2.2 Veterinary surgeons must provide independent and impartial advice and inform a client of any conflict of interest. 
2.3 Veterinary surgeons must provide appropriate information to clients about the practice, including the costs of services and medicines. 
2.4 Veterinary surgeons must communicate effectively with clients, including in written and spoken English, and ensure informed consent is obtained before treatments or procedures are carried out. 
2.5 Veterinary surgeons must keep clear, accurate and detailed clinical and client records. 
2.6 Veterinary surgeons must not disclose information about a client or the client’s animals to a third party, unless the client gives permission or animal welfare or the public interest may be compromised. 
2.7 Veterinary surgeons must respond promptly, fully and courteously to clients’ complaints and criticism.

3. Veterinary surgeons and the profession
3.1 Veterinary surgeons must take reasonable steps to address adverse physical or mental health or performance that could impair fitness to practise; or, that results in harm, or a risk of harm, to animal health or welfare, public health or the public interest. 
3.2 Veterinary surgeons who are concerned about a professional colleague’s fitness to practise must take steps to ensure that animals are not put at risk and that the interests of the public are protected. 
3.3 Veterinary surgeons must maintain and develop the knowledge and skills relevant to their professional practice and competence, and comply with RCVS requirements on the Professional Development Phase (PDP) and continuing professional development (CPD). 
3.4 Veterinary surgeons must ensure that all their professional activities are covered by professional indemnity insurance or equivalent arrangements. 
3.5 Veterinary surgeons must not hold out themselves or others as specialists or advanced practitioners unless appropriately listed with the RCVS, or as veterinary nurses unless appropriately registered with the RCVS.

4. Veterinary surgeons and the veterinary team
4.1 Veterinary surgeons must work together and with others in the veterinary team and business, to co-ordinate the care of animals and the delivery of services. 
4.2 Veterinary surgeons must ensure that tasks are delegated only to those who have the appropriate competence and registration. 
4.3 Veterinary surgeons must maintain minimum practice standards equivalent to the Core Standards of the RCVS Practice Standards Scheme. 
4.4 Veterinary surgeons must not impede professional colleagues seeking to comply with legislation and the RCVS Code of Professional Conduct. 
4.5 Veterinary surgeons must communicate effectively, including in written and spoken English, with the veterinary team and other veterinary professionals in the UK. 
5. Veterinary surgeons and the RCVS 
5.1 Veterinary surgeons must be appropriately registered with the RCVS. 
5.2 Veterinary surgeons must provide the RCVS with their PDP and CPD records when requested to do so. 
5.3 Veterinary surgeons, and those applying to be registered as veterinary surgeons, must disclose to the RCVS any caution or conviction, including absolute and conditional discharges and spent convictions, or adverse finding which may affect registration, whether in the UK or overseas (except for minor offences excluded from disclosure by the RCVS). 
5.4 Veterinary surgeons, and those applying to be registered as veterinary surgeons, must comply with reasonable requests from the RCVS as part of the regulation of the profession, and comply with any undertakings they give to the RCVS. 
6. Veterinary surgeons and the public 
6.1 Veterinary surgeons must seek to ensure the protection of public health and animal health and welfare, and must consider the impact of their actions on the environment. 
6.2 Veterinary surgeons must certify facts and opinions honestly and with due care, taking into account the 12 Principles of Certification. 
6.3 Veterinary surgeons promoting and advertising veterinary products and services must do so in a professional manner. 
6.4 Veterinary surgeons must comply with legislation relevant to the provision of veterinary services. 
6.5 Veterinary surgeons must not engage in any activity or behaviour that would be likely to bring the profession into disrepute or under­mine public confidence in the profession
There is no specific mention of homeopathy in this or the associated guidance. However, it is clear from the above and the guidance that use of homeopathy and homeopathic medicines by veterinary surgeons would raise difficult questions

Details of disciplinary cases by the RCVS can be found here

The RVCS did investigate vet Roger Meacock for misleading advertising. The grounds were bringing the veterinary profession into disrepute. This is a landmark case. Whether there will be further cases of this kind is moot - complaints would have to be brought first. The charges against Meacock involved claims relating to -
It is understood from sources that Meacock has been the subject of multiple complaints to the RCVS. Whilst the action did not involve specific mention of homeopathy, the implications of that the RCVS even looked at the case compared to other regulators is interesting. A full analysis of Meacock's activities are beyond the scope of this post and some might be considered sub judice. 

The "Cascade"
The prescribing cascade is a fundamental issue in veterinary practice. Because of the economics of approval of veterinary medicines, there can be circumstances in which a veterinary surgeon finds there is a not a medicine that is approved for treatment of a certain condition in a certain species. But there is a route to providing treatment - the "cascade". Guidance on legislation states -
The steps, in descending order of suitability, are:
  • a veterinary medicine authorised in the UK for use in another animal species, or for a different condition in the same species
If there is no such product, either:
  • a medicine authorised in the UK for human use, or
  • a veterinary medicine not authorised in the UK, but authorised in another member state for use in any animal species in accordance with the Special Import Scheme; in the case of a food-producing animal the medicine must be authorised in a food producing species
  • a medicine prescribed by the vet responsible for treating the animal and prepared especially on this occasion (known as an extemporaneous preparation or special) by a vet, a pharmacist or a person holding an appropriate manufacturer’s authorisation (so called specials manufacturers)
  • in exceptional circumstances, medicines may be imported from outside Europe via the Special Import Scheme
You or the person acting under your supervision may administer a product prescribed under the cascade; however, the prescription and use of the product remains your responsibility.
Where veterinary homeopathic medicines fall in the cascade is unclear. They are registered with not authorised by the VMD (or in the case of human medicines, the MHRA). 

The least generous interpretation of the cascade would prohibit the use of veterinary homeopathic medicines by veterinary surgeons and confine its use to owners. A slightly more generous would allow the use of homeopathic "specials". The most generous interpretation would treat registered homeopathic medicines as authorised but that would still leave the problem of them have no permitted therapeutic indications or target species. Justifying the use of veterinary medicines as a first choice treatment is extremely problematic when an authorised medicine exists as they will have therapeutic indications and likely a target species.

The VMD did not grandfather in nosodes and sarcodes. Nor will they register these homeopathic medicines. They seem to fall outside of the cascade. If this the case then their use by veterinary surgeons is not permitted. It is also the case that nosodes and sarcodes have been illegally placed on the market by vendors.

Review of Guidance on CAM
Current RCVS guidance on CAM states -
As the regulator of the veterinary profession, we emphasise the importance of evidence-based veterinary medicine. We recommend that there should therefore be a cautious approach to homeopathy for animals and that normal evidential standards be applied to complementary treatments. We believe it is also essential that such treatments, until they can be proved, are complementary rather than ‘alternative’ and that they are therefore used alongside conventional treatment.

However, whatever views there may be within the veterinary profession, it is clear that there is a demand from some clients for complementary therapies for their animals. It is better that they should seek advice from a veterinary surgeon - who is qualified to make a diagnosis, and can be held to account for the treatment given - rather than turning to a practitioner who does not have veterinary training.
Furthermore, homeopathy is currently accepted by society and recognised by UK medicines legislation and does not, in itself, cause harm to animals. While this is the case it is difficult to envisage any justification for banning a small number of veterinary surgeons from practising homeopathy.
The reasons mentioned for the review are changes to NHS position on homeopathy and the line taken by the ASA but it has also been reported that Meacock is another of the motivations. It is also the case that attitudes towards CAM in the veterinary professional have become somewhat firmer on the issues. There are signs that human homeopathy is in decline. It is suspected that one reason for this is that homeopathy practitioners are retiring and new practitioners are increasingly fewer in number. This might also apply to veterinary profession. 

Food Animals and Organic Certification
As mentioned in the previous post, there are restrictions on the medicines that can be used on food animals and how the permitted ones can be used. It would appear that homeopathic medicines are permitted for food animals but the above comments regarding the cascade would also apply.

Whilst many might think that organic is a good thing, organic certification of food animals places additional limitations on what medicines can be used. Organic certification bodies implement EU standards but the EU standards are difficult to read. Fortunately, the Soil Association publish their standards. Section 10.9 deals with veterinary treatment. It is far too long to reproduce here but - 
10.9.1 If you need to use veterinary treatments you must use complementary therapies and trace elements, preferably with professional veterinary guidance, and provided that their healing effect works for the species and the condition you are treating. 
10.9.2 You may only use other veterinary treatments, as advised by your vet, if: - complementary therapies and trace elements don’t work or are unlikely to work effectively and you need to treat to avoid suffering or distress to your animal, or- you have identified a disease risk which prevents you from keeping your animals healthy through management alone. We would, for example, allow the use of cyromazin for fly strike, when this is known to be a problem. You must detail known disease risks in your health plan. 
10.9.3 You must:- use veterinary treatments for your animals, buildings, equipment and facilities if national or EU legislation requires it, even if this means your animals will lose their organic status- have veterinary approval for using unlicensed herbal preparations. 
10.9.4 You must not:- use veterinary medicines as a preventative treatment without our permission - use substances (such as antibiotics or coccidiostats) to increase the growth rate or production of your animals, or- use surgical or chemical procedures on any animal unless it is to improve their health or well-being or that of the group.
The rules are for farmers. As soon as a veterinary surgeon becomes involved, the cascade comes into play as does the RCVS position on CAM, which may change as a result of their review. And what vet would approve the use of unlicensed herbal preparations? There is a concern that farmers will resort to ineffective CAM treatments to preserve organic status when an effective authorised veterinary medicine exists thus, at best, prolonging the suffering of an animal.

Biodynamic certification doubtless is even more restrictive.

Animal Welfare Legislation
The Animal Welfare Act 2006 is the over arching legislation but there is other legislation that covers more specific matters. The Act 2006 does not mention homeopathy or CAM treatment of any kind but there are some provisions in that do cover neglect and the causing of unnecessary suffering and the use of CAM can be considered neglect in some cases.

The Royal Society for the Prevention of Cruelty to Animals (RSPCA) can and do mount private prosecutions against animal cruelty. And some of them have involved homeopathy. Fortunately, they are few and far between. Be aware that some of the listed stories contain upsetting images - 

This story is somewhat different - it is about the potential consequences. There could have been an outbreak of parvovirus. One thing that is not clear is the status of the dog breeder. Dog breeders are covered by the Breeding and Sale of Dogs (Welfare) Act 1999, Breeding of Dogs Act 1991 and Breeding of Dogs Act 1973. To quote from the Act 1973 -
(4) In determining whether to grant a licence for the keeping of a breeding establishment for dogs by any person at any premises, a local authority shall in particular (but without prejudice to their discretion to withhold a licence on other grounds) have regard to the need for securing—

(a)that the dogs will at all times be kept in accommodation suitable as respects construction, size of quarters, number of occupants, exercising facilities, temperature, lighting, ventilation and cleanliness;

(b)that the dogs will be adequately supplied with suitable food, drink and bedding material, adequately exercised, and visited at suitable intervals;

(c)that all reasonable precautions will be taken to prevent and control the spread among dogs of infectious or contagious diseases;

(d)that appropriate steps will be taken for the protection of the dogs in case of fire or other emergency;

(e)that all appropriate steps will be taken to secure that the dogs will be provided with suitable food, drink and bedding material and adequately exercised when being transported to or from the breeding establishment;
And not abiding by these conditions can lead to suspension, loss of license and even prosecution. Vaccination of dogs is a reasonable precaution and there have been prosecutions of breeders who have not vaccinated animals. The idea that homeopathy can be used to vaccinate animals is NOT reasonable. However, if the numbers of litters/puppies is below a certain limit, a license may not be required (but the Animal Welfare Act 2006 would still apply).

There is similar legislation for the boarding of animals, the Animal Boarding Establishments Act 1963. Some boarding establishments are known to accept "certificates" of homeopathic vaccination from vets. This would only breach the terms of the boarding kennel's license, it would raise difficult questions about the vet in question. There is also the Riding Establishments Act 1964 that requires local authority licensing has has similar provisions.

For livestock, there is the Welfare of Farmed Animals (England) Regulations 2007. It does not have anything that particularly adds to the Animal Welfare Act 2006 except - 
1.  Animals must be cared for by a sufficient number of staff who possess the appropriate ability, knowledge and professional competence. 
Competence? There is a course but the claim "Teaching the responsible use of homeopathy on the farm since 2001" seems odd when there is extensive mention of use of nosodes in their newsletter although to be fair, nosodes are always used in "homeopathic vaccination". The legality of supply question is raised again.

There is mention of Bovine TB in reducing the stress experienced by animals during testing.

The Animal Welfare Act 1981 has draconian powers. It is intended to prevent the spread of infectious diseases that can have a devastating effect on livestock. Non-compliance is a criminal matter. The Act 1981 has been amended several times. There is a list of diseases that must be reported to the authorities. This page has a list in a very unhelpful format but Bovine TB is there. Note that it can be passed onto humans and animals. Control of Bovine TB is an emotive subject because of badger culling. There are other approaches to the problem but organic certification can get in the way of, say, setting up a ring fence of vaccinated cattle. Also other countries do ban import of UK animal products such as happened with BSE.

There is no intended implication that any of these farmers would not report Bovine TB or any other notifiable disease if it were detected. There is routine, mandatory testing for Bovine TB.

Because some of the law and guidance is unclear, unfortunately clarification can only be gained by testing both. 

In some ways it would be better for animals, owners, vendors and veterinary surgeons to take a very precautionary approach as view veterinary homeopathic medicines as as a secondary complementary therapy of unknown value. Using veterinary homeopathic medicines as a first-line exclusive treatment is not ethically tenable. Veterinary surgeons could face disciplinary action for doing so by the RSVC and possible criminal prosecution. Breeders, boarding kennels and riding establishments face loss of licence and possible criminal prosecution. Owners risk prosecution if their animals do not get better and they don't seek veterinary treatment.

The most important vendors of non-grandfathered/unregistered veterinary homeopathic medicines are registered pharmacies. They risk suspension and being struck off by the General Pharmaceutical Council (GPhC).

But most of all for all of the above, the UK is an animal loving nation and the stench of bad publicity does not go away.

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