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Peter Reynolds

The life and times of Peter Reynolds

Archive for the ‘Science’ Category

What Is The Matter With Doctors About The Use Of Cannabis As Medicine?

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In the UK, most doctors, and the medical profession as a whole, are ignorant and bigoted about cannabis.

Their ignorance is not entirely their own fault.  For 50-odd years, since cannabis tincture was last available from UK pharmacies, they have been subject to the same relentless tide of propaganda from the Home Office, successive governments, the tabloid press and rabble-rousing politicians as the rest of society.  Many still regard cannabis as a dangerous drug consumed by degenerates that almost inevitably leads to mental illness.  The idea that it could be a safe and effective medicine which offers real benefits in a wide range of conditions is regarded as laughable.

However, there is no excuse for such laziness amongst a profession that regards itself as scientific.  And this is the charge – indolence, carelessness and laziness – that needs to be laid at those doctors at NHS England, the Royal College of Physicians and the British Paediatric Neurologists Association, that are responsible for the disgraceful ‘guidelines’ published two weeks ago.

Throughout Europe, Israel, Canada and the USA there are thousands of doctors who have made the effort to learn about cannabinoid medicine.  They have had to make extraordinary effort to do because even the most basic science is still rarely taught.  The endocannabinoid system is on the syllabus of very few medical schools, anywhere in the world, despite the fact we now know that it is the largest neurotransmitter network in the body and affects almost every aspect of our health and all medical conditions.  This is a dreadful indictment of the medical establishment but particularly of doctors in the UK, very few of whom have made any effort at all.

So while, to a degree, the ignorance can be forgiven, the bigotry cannot. It is cowardice. These doctors prefer to cover their own backs, protect themselves and prefer an absurd level of caution to doing what is in their patients’ best interests.  The incredibly low risk attached to cannabis in any form, at any age and particularly when under medical supervision, is simply overlooked.

Yes, the medical profession is known to be ‘conservative’ but in the case of cannabis this is an excuse.  Yes, we live in an increasingly litigious society but any truly professional doctor would not be cowed by such fear when the evidence is widely available, if they could be bothered to look. And what is this ‘conservatism’ of?  Modern medicine is barely a century old.  It is new in the history of our species and while the reductionist approach has brought great benefit and made huge advances, it is at the expense of thousands of years of human experience which has been dismissed as valueless.

These doctors may feel that the reforms have been foisted on them with no consultation and little notice but this is not a political game, it affects the lives of millions, from the youngest baby to the oldest, most senior citizens.  These doctors are failing in their professional duty.  For too long they have enjoyed being regarded with ultimate respect, rarely being questioned or challenged by their patients but those days are gone.  Most of the population is now far better informed than ever before, largely because of the internet and although this may cause doctors some problems, they have to learn to live with it.  They have to respect their patients, parents and carers and recognise more than ever before that healthcare is about co-operation, about working together. They have to come down from their ivory towers and start delivering truly patient-centred medicine.

 

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Written by Peter Reynolds

November 13, 2018 at 4:57 pm

The Medical Establishment Shows Its True Colours On Cannabis. A Betrayal of Patients.

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NHS England has today published what it describes as prescribing guidance – ‘Cannabis-based products for medicinal use: Guidance to clinicians‘.

The actual guidance is buried within a mountain of bureaucratic doublespeak and requires downloading PDFs from the Royal College of Physicians (download here) and the British Paediatric Neurology Association (download here). In both cases, aside from chemotherapy-induced nausea, the guidance amounts to ‘do not prescribe’. This is a travesty of the intention of these reforms and demonstrates how the medical establishment is more interested in protecting its self-interest than in helping patients gain the benefits of cannabis as medicine. Cowardly and scared are the two words which best sum this up.

It’s no surprise that doctors in the UK are ignorant about the use of cannabis as medicine. They have been subject to the same relentless torrent of reefer madness propaganda from government and media as the rest of society. They have been prevented even from learning about the endocannabinoid system by the authoritarian policy of prohibition and any doctor in the UK who has any experience of cannabis as medicine will have been in breach of professional ethics as well as the law.

But it’s deeply disappointing that the authors of these documents have made no effort to understand the excellent work that is being done by medical professionals in other countries.  The Royal College of Physicians and the BPNA will be a laughing stock across the world in the many more enlightened and educated jurisdictions where patients are gaining great benefit. But of course, this isn’t a laughing matter. In fact, these two so-called professional bodies are making it a tragedy.

Clearly, what is in the best interests of patients is that we must bring in expertise from overseas.  There are eminent doctors abroad who will be glad to step in, particularly in private practice, and pick up this baton which the NHS has fumbled and dropped in the most clumsy fashion.

This is a huge opportunity for those in private medicine who can set aside these cowardly excuses and make the most of the new regulations for patients who are fortunate enough to be able to afford it.

For the average Briton with chronic pain, Crohn’s Disease or an epilpetic child this is a kick in the teeth from the profession that is supposed to care for them.

Written by Peter Reynolds

October 31, 2018 at 6:14 pm

Cannabis Advocates Really Need To Stop Accusing Doctors of Being Bribed By Pharmaceutical Companies.

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There may well be some doctors who are corrupt and there are still, despite much improvement, serious questions over the relationship between pharma companies and doctors but the idea that every member of the Faculty of Pain Medicine who signed that letter to the Times is taking bribes is ridiculous.

The real reason is ignorance and that’s not an attack on doctors, it’s a reason.  They have been subject to the same relentless torrent of reefer madness propaganda from government and media as the rest of society.  They have been prevented even from learning about the endocannabinoid system by the authoritarian policy of prohibition and any doctor in the UK who has any experience of cannabis as medicine will have been in breach of professional ethics as well as the law.

CLEAR has been working with some of the very few enlightened doctors since way before the cause of cannabis as medicine became fashionable.  Working with members, their MPs and doctors, we have organised lobbying of ministers and MPs over more than the past 10 years. In several instances we had doctors, both GPs and consultants, contact the Home Office to enquire about obtaining a licence for a specific patient.  In at least three instances these doctors were then contacted by Home Office officials who warned them off using threats and intimidation.  Shocking but completely true.

It is and it always has been government – stupid, prejudiced, bigoted and self-opinionated politicians – who have prevented access to cannabis, even in the face of overwhelming evidence.  This means that there has been no education at all and doctors are as poorly informed as everyone else. They’re also, and understandably, worried, even scared.  They don’t understand cannabis, many will not even have heard of the endocannabinoid system and they are concerned about being sued, professionally disgraced, losing their job and now of being swamped by patients demanding cannabis about which they know nothing.

Of course, it was thoroughly stupid to assert in the letter that “the evidence suggests that the prescribing of cannabis (containing the psychoactive and addictive tetrahydrocannabinol component) will provide little or no long-term benefit in improving pain and may be associated with significant long-term adverse cognitive and mental-health detriment.”

There is no reasonable interpretation of the evidence that supports this. THC can be addictive in a very modest sense but the withdrawal symptoms and negative effects are trivial compared to those from opioids which doctors prescribe readily and frequently.  There is excellent evidence from many sources that cannabis containing THC and CBD benefits pain and while there may be some cognitive and mental health effects, to suggest they are significant or even come remotely close to those from opioids is false and in opposition to the evidence.

I repeat, doctors aren’t saying this because they are bribed by pharmaceutical companies, it’s because they have no idea what they are talking about.

The urgent requirement now is medical education.  It is amazing how radical the new regulations are and many people still don’t seem to realise how far the government has gone.  They go much further than we at CLEAR had even dared to dream and the definition of cannabis-derived medicinal product (CDMP) is very broad.  When we were consulted on it by the Department of Health and MHRA we never thought they would accept all our recommendations.  They enable the prescription of every form of cannabis, including flower, oil and concentrate, provided they meet quality standards.

So the problem with the law is gone. Literally, it is all over. It is absolute and total victory. Now two big problems remain. Education is the first but this is being addressed.  NICE has acted commendably fast to start recruiting a panel to advise on prescribing guidelines and Professor Mike Barnes, CLEAR’s scientific and medical advisor has already developed a series of introductory online training modules. Early in November his Medical Cannabis Clinicians Society launches and this will be an important forum for the future.

The second big problem is supply.  Where are the CDMPs to come from?  Sativex falls into the definition and this was GW Pharma’s big opportunity to act responsibly and imaginatively.  The possibility still exists that it will substantially reduce the absurd, rip-off price that it has been charging for Sativex since 2010.  If it had the imagination it could very easily turn over some of its production to unlicensed CDMPs for which there is now a ready market. I fear that it is wedded to licensed products only, hugely expensive and, in my judgement, unnecessary clinical trials and very high prices for its end products.  If so, then I will be selling my shares.  I admire the company for its courage, innovation and high standards but if it does not seize this opportunity then I believe it is failing in its duty to shareholders and also to Britain, which let’s remember has gifted it a privileged and unique opportunity in the world.  Fail now to provide for the needs of UK patients and that amounts to betrayal.

So for now the only possible sources of supply that meet the definition will be Bedrocan in the Netherlands and some of the Canadian licensed producers. US companies cannot export.  Neither can the Israeli companies and they would also face a thoroughly deserved boycott of their products even if Netanyahu was to issue export licences.  Bedrocan can barely meet demand from its existing customers and there is talk of it having difficulties with a ceiling on its export licenses. Only some Canadian producers meet the required GMP quality standards and they too are facing shortages as they also supply the recently legalised recreational market which is seriously short of product.

So the Home Office has to act and start issuing domestic production licences and it has to do so immediately.  Whether it will, remains to be seen.  Its drugs licensing department is a shambles, staffed by officials who do not even understand the law they are supposed to administrate, who regularly give different, contradictory answers on different days and exceed their lawful authority as a matter of course.  If there is a ‘hostile environment’ for immigration in the Home Office, for drugs licensing and cannabis production it has been hostile but also aggressive, paranoid and stupid ever since the Misuse of Drugs Act 1971.

The urgent need is for prospective British cannabis producers to mobilise their MPs and for immediate pressure to be brought on the Home Office at the highest level.  Sajid Javid has shown he can act decisively.  Expanding domestic cannabis production is the inevitable next step in what he has already achieved.  He must act now.

So the future in the UK for those who need cannabis as medicine is brighter than could ever have been imagined.  The next steps are challenging but nowhere near as difficult as the campaign to reform the law that CLEAR has fought for nearly 20 years.  Don’t blame doctors, continue to blame the government and hold their feet to the fire until they act on medical education and cannabis production as they must.

British Doctors Don’t Understand Cannabinoid Medicine. They’ve Been Denied Education In The Basic Science.

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Today’s letter to the Times from a group of pain medicine consultants (reproduced below) is is an astonishing display of evidence-free ignorance from a profession that needs to challenge its own prejudice.

To compare the addiction potential of cannabis with opioids is ridiculous and demonstrates just how detached from the science and evidence are those making this claim.

Doctors will understandably feel challenged by a medicine that upturns many of their conventional habits. They have been prevented from understanding the science of cannabis as medicine by prohibition policy. Most doctors have received no education at all about the endocannabinoid system which we now know is the largest neurotransmitter network in the body and is the mechanism by which cannabis exerts its therapeutic effects.

Understanding cannabis as a medicine requires a new attitude and mindset which looks at the patient’s overall health and physiological stability or homeostasis. Modulating the endocannabinoid system with cannabis can effect many factors which contribute to illness including pain, mood, memory and perception. It’s actually a much more complex model rather than the simplistic, reductionist theories that modern medicine is based on.

‘Holistic’ is a fashionable but much misused word that is truly expressed in cannabinoid medicine. There are a few progressive doctors in the UK, including some pain consultants, who through experience and self-education have learned how this new approach to medicine works.

Outside the UK, in jurisdictions which have taken a more enlightened approach, cannabinoid medicine is much better understood by many more doctors. The profession in UK needs to open its mind and its doors to education and training from overseas. Then they will start to understand this much more rounded and broadly-based approach which can lead to a long-term, preventative approach with fewer side effects and better outcomes for nearly all patients.

 

Letter to The Times, 26th October 2018

CANNABIS PAIN RELIEF

Sir, We, as a group of pain medicine consultants, are concerned that the Home Office and NHS England propose to allow specialist doctors to prescribe cannabis for chronic pain from next month. We know only too well the unmet burden of chronic pain and that pain is cited by our patients as a frequent reason to take cannabis.

While there are clear limitations in studying the effects of past illicit cannabis use, caution is required, as the evidence suggests that the prescribing of cannabis (containing the psychoactive and addictive tetrahydrocannabinol component) will provide little or no long-term benefit in improving pain and may be associated with significant long-term adverse cognitive and mental-health detriment.

We are also concerned that it will be difficult to deny cannabis prescriptions to patients in pain who might be coerced into diverting cannabis into the community where it will remain illegal and have street value.

We have suffered an opioid crisis and foresee history about to repeat itself. Ironically, the likely cost of medical cannabis will be greater than the saving achieved by the inexplicable decision of NHS England to restrict the use of the clinically effective 5 per cent lidocaine plasters.

We support the change in the law to encourage cannabis research. However, we are concerned that in the interests of political expediency, this mandate to allow prescribing of cannabis for pain relief is premature. That cannabis is an effective treatment for chronic pain is not supported by the evidence and may be associated with significant harm.

Dr Rajesh Munglani, consultant in pain medicine London; Dr Andrew Baranowski, consultant in pain medicine, University College London Hospitals NHS Trust; Dr Stephen Ward, consultant in pain medicine Brighton and Sussex Hospital Trust; Dr Arun Bhaskar, consultant in pain medicine Imperial College NHS Trust; Dr Cathy Price, consultant in pain medicine St Mary’s Portsmouth Solent NHS Trust; Dr Jonathan Bannister, consultant in pain medicine NHS Tayside Scotland; Dr Ilan Lieberman, consultant in pain medicine University Hospital of South Manchester; Dr Dalvina E Hanu-Cernat, consultant in pain medicine Queen Elizabeth Hospital Birmingham; Dr Pravin Dandegaonkar, consultant in anaesthesia and pain medicine; Calderdale and Huddersfield NHS Foundation Trust; Dr Sarang Puranik, consultant in pain management and anaesthesia Kingston Hospital, Surrey; Dr Mike W Platt, consultant in pain medicine Imperial College Healthcare NHS Trust; Dr Jon Valentine, consultant in pain medicine Norwich; Dr Teodor Goroszeniuk, consultant in pain medicine, London W1, UK; Dr Michael Coupe consultant in anaesthesia, pain medicine and intensive care Royal United Hospitals NHS FT; Dr Hadi Bedran, consultant in pain medicine St Georges University Hospitals NHS Trust; Dr Karen H Simpson, consultant in pain medicine Leeds; Dr Aditi Ghei, consultant in pain medicine, West Herts NHS Trust; Dr Kiran Koneti, consultant in pain management City Hospitals Sunderland NHS Trust; Dr Tim McCormick, consultant in pain medicine Oxford pain Management Centre; Dr Sadiq Bhayani, consultant in pain medicine University Hospitals Leicester NHS Trust; Dr Nicholas M Hacking, consultant anaesthetist, Lancashire Teaching Hospitals NHS Trust; Dr Joshua Adedokun, consultant in pain medicine, The Pennine Acute NHS Trust; Dr Neil Collighan, consultant in pain medicine East Kent Hospital NHS Trust; Dr Bela Vadodaria, consultant in anaesthesia and pain management The Hillingdon Hospital; Dr Fraser Duncan, consultant anaesthetist and pain specialist Birmingham; Dr Hoo Kee Tsang, consultant in anaesthesia and pain medicine, Royal Liverpool and Broadgreen University Hospitals NHS Trust; Dr Richard Gordon-Williams, APT, University College London Hospitals NHS Trust; Dr A Tameem, consultant in anaesthesia and pain management Dudley group of hospitals; Dr Marcia Schofield, pain sPecialist West Suffolk NHS Trust Bury St Edmunds; Dr Giancarlo Camilleri, consultant Ashford & St Peter’s Foundation NHS Trust Chertsey; Dr Joseph Azzopardi, consultant in pain medicine London; Dr Dick Atkinson, retired consultant in pain medicine Central Sheffield University Hospitals; Dr Basil Almahdi, consultant in pain medicine London; Dr Katharine Howells, consultant in pain medicine, RUH Bath NHS Foundation Trust; Dr G Baranidharan, consultant in pain medicine, Leeds Teaching Hospitals NHS Trust; Dr Philippa Armstrong, consultant in anaesthesia and pain medicine, York Teaching Hospitals NHS Trust; Dr Lourdes Gaspar, consultant in pain medicine Orthopaedic Hospital Oswestry; Dr Carolyne Timberlake, consultant in pain medicine Kings College Hospital NHS Trust; Dr Intazar Bashir, consultant in pain medicine Worthing; Dr Mark Sanders,consultant in pain medicine at Norfolk and Norwich University Hospital; Dr Andrzej Krol, consultant in pain medicine St George’s Hospital London; Dr Peter Hall, consultant in pain Management York Hospitals NHS Trust; Dr Susmita Oomman, consultant in pain and Anaesthetic Withybush General Hospital Hywel Dda NHS Trust; Dr Sue Jeffs, consultant in anaesthesia and pain Management Abergavenny Wales; Dr Murali-Krishnan, consultant in pain medicine Northampton; Dr Sabina Bachtold, ST7 pain medicine (APT)/anaesthesia London; Dr A Ravenscroft, consultant in pain Management Nottingham University Hospitals; Dr Sanjay Kuravinakop , consultant in pain medicine Dartford and Gravesham NHS Trust; Dr Nicolas Varela, consultant in pain medicine Royal National Orthopaedic Hospital NHS Trust; Dr Michael Atayi, consultant in pain medicine George Eliot Hospital; Dr Carl TJ Broadbridge, consultant in pain medicine and anaesthesia Salisbury District Hospital; Dr Ramy Mottaleb, Kingston NHS Foundation Trust; Dr Richard Sawyer, consultant in anaesthesia and pain management, Oxford University Hospitals NHS foundation Trust; Dr Rajesh Menon, consultant in pain medicine Calderdale and Huddersfield NHS Trust; Dr Jeremy Weinbren, consultant in Anaesthetics and pain medicine Hillingdon Hospital; Dr Paul Rolfe,consultant in pain medicine Cambridge; Dr Brian Culbert, consultant in pain medicine East Yorkshire Hospitals NHS Trust; Dr Rokas Tamosauskas, consultant in pain medicine Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust; Dr David Gore ST6 Advanced pain Trainee, Oxford University Hospitals; Dr Manohar Sharma, consultant in pain medicine The Walton Centre NHS Foundation Trust, Liverpool; Dr Jayne Gallagher, consultant in pain medicine Barts Health Trust London; Dr Raju Bhadresha, consultant in pain medicine and anaesthesia East Kent Hospitals University Foundation Trust; Dr Owen Bodycombe, consultant anaesthesia and pain medicine Gloucestershire Hospital’s NHSFT; Dr Ramy Mottaleb,consultant in pain medicine Kingston NHS Foundation Trust; Dr Christian Egeler, consultant in anaesthesia and pain medicine, Swansea ABMU HB; Dr Deepak Malik, consultant in pain Management University Hospitals Birmimgham NHS Foundation Trust; Dr Mohjir Baloch, consultant in pain Management Frimley Park Hospital; Dr Martyna Berwertz, consultant in pain medicine Sheffield Teaching Hospital NHS Foundation Trust; Dr Ron Cooper, consultant pain medicine & anaesthesia Causeway Hospital, Coleraine, N Ireland; Dr Ashish Shetty, consultant in pain medicine, University College London Hospitals; Dr S J Law, consultant in pain medicine West Suffolk Hospital; Dr M Mali, consultant in pain medicine Darent Valley Hospital; Dr S James consultant and Lead Clinician Chronic pain Services NHS Lanarkshire; Dr Sarah Aturia,consultant pain and Anaesthetics Milton Keynes University Hospital NHS Foundation Trust; Dr Henriette van Schalkwyk, consultant in pain medicine North Hampshire hospital Basingstoke; Dr Shamim Haider, consultant in pain medicine East Suffolk & North Essex NHS Foundation Trust Colchester & Ipswich; Dr Simon Thomson, consultant in pain medicine and Neuromodulation, Basildon; Dr Danielle Reddi, Locum consultant in pain medicine University College London Hospitals NHS Trust; Dr Thomas Samuel, consultant in pain medicine East and North Herts NHS Trust; Dr Arindam De, pain Management consultant University Hospitals of Morecambe Bay (UHMB); Dr Evan Weeks, consultant in anaesthesia & pain medicine Addenbrooke’s Hospital, CUHFT; Dr Ravi M Kare, consultant in pain Management and anaesthesia Norfolk & Norwich University Hospitals; Dr Niranjan Chogle, consultant in pain medicine Ulster Hospital, Northern Ireland; Dr William Campbell, consultant Emeritus and Past President British pain Society, Ulster Hospital Dundonald; Dr Subramanian Ramani, consultant in pain medicine Northampton General Hospital; Dr Adrian Searle, consultant in anaesthesia and pain medicine, Derby; Dr Sameer Gupta, consultant in anaesthesia and pain Management DRG Health Clinic Doncaster; Dr Diana Dickson, Retired consultant in pain medicine, Leeds; Dr Attam Singh, consultant in pain medicine West Hertfordshire NHS Trust; Dr James Wilson, consultant in anaesthesia & pain medicine Maidstone & Tunbridge Wells NHS Trust; Dr Sharmila Edekar, pain Specialist Glangwili Hospital Hywel Dda HB; Dr Bernard Nawarski, consultant in pain medicine Frimley Health; Dr Sridevi Ramachandran, consultant in pain medicine, Anglian Community Enterprise; Dr John Wiles, consultant in pain medicine The Walton Centre NHS Foundation Trust; Dr A T Arasu Rayen, consultant in pain Management, Sandwell and West Birmingham NHS Trust; Dr John Titterington, consultant pain Management, Leeds Teaching Hospitals; Dr Deepak Subramani, consultant in anaesthesia and pain Management George Eliot Hospital; Dr Ian D Goodall, consultant in pain medicine, Chelsea and Westminster Hospital NHS Trust; Dr Seshu Babu Tatikola, consultant In pain medicine & Anaesthesia, Hull and East Yorkshire Hospitals NHS trust; Dr Kevin Markham, consultant in pain medicine Surrey Heath Community pain Clinic; Dr Husham Al-Shather ,consultant in pain medicine Royal Berkshire NHS Foundation Trust; Dr K.Dhandapani, York Hospitals NHS foundation Trust York; Dr Chris Naylor, consultant in pain medicine, Southend University Hospital NHS Trust; Dr Sally Ghazaleh, Locum pain consultant Royal Berkshire hospital; Dr Bala Veemarajan ,Sherwood Forest Hosp NHS trust; Dr GR Towlerton, consultant in pain medicine, Chelsea & Westmister Hospital; Dr Mandar Joshi, consultant in anaesthesia and pain medicine, Aneurin Bevan University Health Board; Dr Ashish Wagle,consultant Anaesthetist and pain specialist Cwm Taf University Health Board Wales; Dr A Doger, consultant University Hospitals Birmingham & Associate Medical Director John Taylor Hospice; Dr Salmin Aseri, consultant in pain medicine & Anaesthesia; St Helens & Knowsley Teaching Hospitals NHS Trust; Dr George Harrison, consultant in pain medicine, Birmingham Queen Elizabeth Hospital; Dr Rashmi Poddar, pain consultant Kettering General Hospital; Dr Ashish Gulve; consultant in pain Management The James Cook University Hospital Middlesbrough; Dr Yaser Mehrez,consultant in pain medicine and anaesthesia Milton Keynes University Hospital NHS Trust; Dr Victoria Tidman, consultant in pain medicine University College London Hospitals NHS Trust; Dr Tacson Fernandez,consultant in pain medicine Royal National Orthopaedic Hospital; Dr Kim Carter, consultant Anaesthetist & pain Northampton General Hospital; Dr Anand Natarajan, consultant in pain Management Wirral University Teaching Hospitals; Dr Dominic Aldington consultant in pain medicine Royal Hampshire County Hospital; Dr Emma Chojnowska, consultant in pain medicine and anaesthesia Chichester; Dr Liza Tharakan, consultant in pain medicine and Anaesthesia; Royal Orthopaedic Hospital; Dr Moein Tavakkoli, consultant in pain medicine University College London Hopsital (NHNN); Dr Manojit Sinha ,consultant pain medicine King’s College Hospital NHS Foundation Trust; Dr Sanjay Varma,consultant in pain Management Sunderland Royal Hosptal Sunderland; Dr Shravan Tirunagari, consultant anaesthesia and pain Management, East and North NHS Trust Hospitals; Dr Monica Chogle, consultant in Anaesthetics and pain Northern Health and Social Care Trust Northern Ireland; Dr Subhash Kandikattu, consultant in pain Management, Peterborough City Hospital North West Anglia NHS FT; Dr Jan Rudiger, consultant in Anaesthetics and pain medicine, Redhill; Dr Arun Sehgal, consultant in pain medicine and Anaesthesia,Peterborough and Stamford Hospitals; Dr Matthew LLoyd Hamilton, consultant in anaesthesia and pain medicine, Homerton University Hospital NHS Foundation Trust, London Dr Athmaja Thottungal, consultant and Trust Clinical lead for pain management, East Kent Hospitals NHS Trust; Dr Rubina Ahmad, Title: Locum consultant, work place; Brighton and Sussex University Hospital NHS Trust: Dr Sean White, consultant in pain medicine, London pain Service; Dr Anup Bagade, consultant in pain medicine East and North Herts NHS Trust; Dr Tom Smith, consultant in pain medicine London; Dr Jason Brooks, consultant pain medicine Belfast Health and Social Care Trust; Dr Vinay Anjana Reddy, consultant in pain and anaesthesia University Hospital Lewisham; Dr S Murugesan, consultant in anaesthesia and pain management, Wrightington Wigan and Leigh NHS Foundation Trust; Dr Nancy Cox, APT, University Hospital Coventry and Warwick NHS Trust; Dr Ashwin Mallya, Northern Lincolnshire and Goole Hospital NHS Trust; Dr M Serpell, consultant & Senior Lecturer in pain medicine & anaesthesia Greater Glasgow & Clyde NHS; Dr Srinivas Bathula, consultant in pain Management Heart of England NHS Trust University Hospital, Birmingham; Dr Ann-Katrin Fritz, consultant Alain Management Norfolk & Norwich University Hospital; Dr Ashok Puttappa, consultant in anaesthesia and Chronic pain University Hospital North Midlands Stoke on Trent; Dr Tom Bendinger, consultant in anaesthesia and pain medicine Sheffield Teaching Hospitals; Dr Sumit Gulati,consultant in pain medicine and anaesthesia Walton Centre NHS FT, Liverpool UK;Dr Arun Natarajan, consultant in pain medicine Hillingdon Hospital; Dr Katrina Dick, consultant in anaesthesia and pain medicine Ayrshire and Arran; Dr Shefali Kadambande , consultant in anaesthesia and pain management University Hospital of Wales; Dr Nick Roberts, consultant in pain Management Kettering General Hospital; Dr Somnath Bagchi, consultant in pain medicine University Hospitals Plymouth UK; Dr Lakshman Radhakrishnan, consultant in pain management Royal Lancaster Infirmary; Dr Stephan Weber, consultant in pain Management BMI Goring Hall Hospital; Dr Kiran Sachane consultant in pain medicine NHS Lothian pain Service, Edinburgh Scotland; Dr James Blackburn, consultant in pain medicine, St George’s Healthcare NHS Trust; Dr Srinivas Bathula, consultant in pain medicine, University Hospitals Birmingham NHS FT; Dr Ravi Srinivasagopalan, consultant in pain Management and anaesthesia The Hillingdon Hospitals NHS FT; Dr John Goddard, consultant in Paediatric pain medicine Sheffield Children’s Hospital; Dr Chad Taylor, pain medicine consultant, Jersey (Channel Islands UK); Dr Udaya Kumar Chakka, consultant in pain medicine, Coventry; Dr Pallav Desai, Neuromodulation Fellow, James Cook University Hospital; Dr Azfer Usmani, Dartford and Gravesham NHS Trust; Dr Neal Evans, consultant in pain medicine Bucks Hosps NHS Trust; Dr Kanar Al-Quragooli, Associate Specialist in anaesthesia and pain medicine , Manchester FT; Dr Valentina Jansen, consultant in pain and anaesthetics Glangwili General Hospital Hywel Dda NHS Trust; Professor Emeritus Sam H Ahmedzai, University of Sheffield; Dr Mike Hudspith, consultant in pain medicine Norfolk & Norwich University Hospital;

Written by Peter Reynolds

October 26, 2018 at 9:46 am

CLEAR Advises Department of Health and MHRA on Definition of Cannabis-Derived Medicinal Products.

with 5 comments

Last week, CLEAR was invited to participate in a teleconference with representatives of the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA).  This followed our written submissions made over the last few weeks.

The teleconference included two representatives from each party. The DHSC was represented by the Medicines Pharmacy and Industry section. The MHRA was represented by the Licensing Division.

CLEAR has now submitted a summary of all the advice offered which is reproduced below.

1. The definition of cannabis-derived medicinal products (CDMP) is for products that will be re-scheduled in the Misuse of Drugs Regulations out of schedule 1 and ostensibly into schedule 2.  These products will be available for prescription by doctors.

2. With the exception of Sativex, a whole plant cannabis extract with a THC:CBD ratio of 1:1, there are no cannabis-derived medicinal products available in the UK which have been licensed by the granting of a marketing authorisation (MA) or a Traditional Herbal Registration (THR). THR licensing is for minor ailments only that do not require the supervision of a doctor. MA licensing would be required for any CDMP aiming to treat most of the conditions for which cannabis is currently being used illicitly unless such CDMPs are prescribed as an unlicensed medicine.

3. In every other jurisdiction in the world where CDMPs are legally available, governments have recognised that licensing regimes designed to regulate single molecule pharmaceutical medicines synthesised in a lab are not suitable for regulating CDMPs. All such governments have either established entirely new cannabis regulators or created a specialist division within the existing medicines regulator.  If there is a genuine intent to enable legal access to CDMPs by the estimated one million people currently using illicit cannabis as medicine, this is the only practical route forwards. The cost and length of time involved in obtaining an MA makes them prohibitive for a plant-based medicine. Given the experience of using cannabis as medicine over many millennia, its non-toxic nature and very low risk profile, the rigorous approach of an MA is unnecessary.

Recommendation 1. A CDMP regulator should be established encompassing genuine expertise in the use of cannabis as medicine. The Cannabis Trades Association UK (CTA) is already in the process of developing the Cannabis Products Directive (CPD) in co-operation with the MHRA and FSA.

4. There is no justification or evidence that can support cannabis being in such a restrictive schedule as schedule 2 alongside opioids and cocaine.  The potential for causing social harm, which is the criterion used to determine the correct schedule, is several orders of magnitude greater with all existing schedule 2 drugs. They are all demonstrated to produce far higher levels of problematic dependence and long-term health harms than cannabis.

Recommendation 2. CDMPs should be re-scheduled into schedule 4 alongside Sativex.

5. The primary objective of the definition should be to ensure that the products are safe. Cannabis is non-toxic with no practical lethal dose and any harmful health or social effects are only likely with sustained and abusive use. In normal, moderate and especially medical use the potential for any harm is extremely low, certainly no higher than with common over-the-counter medicines. The main safety considerations are therefore the risk of contamination during cultivation and in subsequent processes such as extraction and refinement of oils, arising from the use of pesticides, herbicides, nutrients and solvents.

6. The definition should be wide enough to encompass all cannabis products that are produced to specified quality standards. It should not be so narrow as to prohibit high THC and/or low CBD products that may well be appropriate in individual circumstances. Prescribing guidelines should be issued to enable doctors to make appropriate clinical judgements on appropriate THC:CBD ratios for different conditions. These guidelines must be compiled by experts in the use of cannabis as medicine, not by the ‘non-experts’ who have been appointed to the expert panel on cannabis-derived medicine.  FOI Requests have revealed that none of the members of the panel have any knowledge, experience or expertise in the use of cannabis as medicine.

7. The definition should be wide enough to provide for a future in which doctors can vary THC:CBD ratios and terpene content in accordance with evidence for therapeutic effect. For example, in paediatric epilepsy, CBD has been shown to be the most important compound but some children require a small percentage of THC for it to become effective.  Doctors should be free to vary dosage in the same way as they do with many licensed medicines in accordance with the way the patient responds.

8. Regulators/authorities will properly require some independent assessment of the safety of products as defined above. The only such assessments currently available are Good Manufacturing Practice (GMP) and certification by the Cannabis Trades Association UK (CTA). By definition, these certifications are only available for products that are legally available and CTA only operates within the UK where only exempt, low-THC products (known as CBD products) are legally available. GMP certification is available on some cannabis products legally available outside the UK.

9. Cannabis consists of around 500 molecules including approx. 110 cannabinoids, 120 terpenes and 20 flavonoids which provide the important therapeutic effects, most effectively, when working together in what is known as ‘the entourage effect’. The most significant cannabinoids are believed to be THC and CBD. THC has long been demonised as the principal psychoactive component but it has very important therapeutic effects, notably as an analgesic, an anti-spasmodic and an appetite stimulant. CBD works as an analgesic, anti-inflammatory, anxiolytic and anti-psychotic.  It is beyond doubt that they work best together as they enhance each other’s positive effects and ameliorate any side effects. It is vital that cannabis for medical use contains a balance of both.  In some conditions, THC is more important than CBD and in others the reverse will be the case. We recommend that for medical use the ratio of THC:CBD should ideally not be less than 10:1.  This will protect against any negative effects of THC which a very small proportion of patients may be vulnerable to. In most instances, for medical use, the ideal THC:CBD ratio will be 1:1. Doctors should however be free to prescribe outside these parameters including high THC and high CBD products, subject to prescribing guidelines.

Recommendation 3. The definition of CDMPs should be primarily concerned with safety in the production process. CDMPs should have either a. GMP certification b. CTA certification c. an existing MA d. an existing THR. The composition and cannabinoid ratios of CDMPs should be a matter for determination by doctors in accordance with prescribing guidelines.

Recommendation 4. Prescribing guidelines for CDMPs should be developed by experts in the use of cannabis as medicine, not by the ‘non-experts’ who have been appointed to the expert panel on cannabis-derived medicine. 

10. Cannabis has traditionally been smoked and millions of people have gained great benefit from it over many centuries. The principal benefits of smoking, which are extremely important, without any of the negative effects, can now be achieved through vaporising. The benefits are rapid onset of therapeutic effect and accurate self-titration of dose.  When ingested, either through the GI system or absorbed through the mucus membranes, onset is much slower, the effect is prolonged and accurate titration is very difficult to achieve. Vaporisers are already in widespread use and a variety of different types are available.  The Storz and Bickel ‘Volcano’ has a CE mark and is a licensed medical device in Canada and Israel. The Teva Pharma ‘Syqe’  has completed three clinical trials with positive outcomes for safety and efficacy.

11. Vaporised, pharmaceutical-quality, standardised herbal cannabis with consistent cannabinoid and terpene levels is the gold standard in the use of cannabis as medicine.  Presently the only way to achieve this in Europe is with GMP-certified cannabis produced by Bedrocan BV, the Netherlands government officially contracted producer.  Some Canadian producers are also GMP certified.

Recommendation 5. Vaporisers should be made available on loan, for subsidised purchase or free-of-charge in accordance with existing provision for those in receipt of benefits.

12. The DHSC should prevail on GW Pharmaceuticals to reconsider its pricing strategy on Sativex which is presently under a ‘do not prescribe’ edict from NICE on the grounds that it is not cost-effective. The price of Sativex is extraordinarily high and products which, for all practical considerations of safety and efficacy, are identical are available over-the-counter for one-tenth of the price in US cannabis dispensaries. There is no justification for the price of Sativex except for the recovery of the cost of clinical trials which GW Pharma was required to engage in in order to obtain a marketing authorisation.  GW Pharmaceuticals should also be encouraged to make herbal cannabis products available as an alternative to Bedrocan, something it should be able to achieve within a few months with little difficulty.

13. Cannabis extracts and oils will be required for some patients, particularly children, and those that cannot or do not wish to use inhalation via a vaporiser.  Prescribing guidelines must recognise that the pharmacology of cannabis is totally different when ingested through the GI system or absorbed through the mucus membranes.  Absorption of oil through suppositories has also been found to a valuable method of ingestion.

14. While CLEAR fully supports decriminalisation of domestic cultivation of cannabis for personal use, homegrown cannabis should never be considered part of a therapeutic programme under the supervision of medical professionals.  The potential for contamination and poor quality is far too high.

Recommendation 6. In the short term, aside from low-THC exempt products known as CBD products, the only CDMPs readily available are from GW Pharmaceuticals, Bedrocan BV or Canadian producers, notably Tilray. Standardised herbal cannabis for vaporising or oils for other methods of ingestion should be available from these producers immediately.

15. Originally Nick Hurd MP, the Home Office minister, wrote in The Times, 29th June 2018, that cannabis would be rescheduled and could be prescribed by GPs whenever a benefit could be identified. Without any explanation that now appears to have morphed into ‘specialist’ or ‘senior’ clinicians and only in cases of ‘exceptional clinical need’.  As well as a broken promise which is causing widespread consternation, this is irrational, as are suggestions that cannabis should be regarded as a medicine of last resort.  The safety profile of cannabis is such that any rational, evidence-based policy would suggest cannabis as a medicine well before many analgesics, anxiolytics and anti-depressants which are widely, readily and regularly prescribed by doctors without any concern.

16. A workable definition of CDMPs together with well-informed prescribing guidelines that enable prescription by GPs for any condition where a benefit is identified is essential. Unless this is satisfactorily achieved, the one million people in the UK currently using cannabis as medicine will continue to do outside the law, outside any form of medicines regulation and without any medical supervision.  The likelihood is that this cohort of patients will continue to expand rapidly as knowledge of the therapeutic benefits of cannabis and its use in other countries becomes more widespread. The implications of failing to establish a proper regime are very significant for health, patient-doctor relationships, the criminal market in cannabis, the police and the criminal justice system. This is a nettle that must be grasped.

Recommendation 7. CDMPs should be available in accordance with the Home Office’s initial commitment, that is on prescription by GPs for any condition where a benefit can be identified

The Definition Of A Cannabis-Derived Medicinal Product Must Include Standardised Herbal Cannabis Or Sajid Javid’s Reform Will Fail.

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Bedrocan, the Netherlands government’s official producer, grows cannabis in which the cannabinoid and terpene content is standardised and consistent. It does this by very careful cultivation techniques which include clonal propagation, continuous analysis and gamma irradiation to eliminate contamination with potentially harmful microbes. Its production facility is Good Manufacturing Practice (GMP) certified.

With the exception of Sativex, which NICE has declared as not cost effective, the Bedrocan range offers the only medicinal cannabis products which could be readily available in the UK.  They are also available as oils extracted directly from the raw herbal flowers.

It’s very simple, unless Bedrocan products come within the definition of a ‘cannabis-derived medicinal product’, the very welcome reform announced today by Sajid Javid will fail and most people will have no option but to continue sourcing their medicine from the illegal market.

There is no doubt that the gold standard in safety, efficacy and self-titration is vaporised herbal cannabis of Bedrocan-standard quality.  Cannabis that is ingested as oil, either sub-lingually or through the gastrointestinal system, has a substantially different pharmacology and is very difficult to titrate accurately or to deliver its beneficial effects promptly.

Bedrocan provides an immediate solution.  GW Pharmaceuticals could also easily turn to providing a similar range of products.  One hopes that it could also be prevailed upon to reconsider its pricing of Sativex. It is essential however that new, domestic production facilities are established quickly.  Up to now the Home Office has rejected all efforts to set up such facilities, even applications from extremely reputable international businesses that already have licences elsewhere.  This policy must be immediately revised.

Dame Sally Davies advised that “only cannabis or derivatives produced for medical use can be assumed to have the correct concentrations and ratios”. The ACMD agreed with this, stating that “raw cannabis (including cannabis-based preparations) of unknown composition should not be given the status of medication.”  Bedrocan products fully comply with these requirements and it is essential that they are re-scheduled and made available on prescription.

Written by Peter Reynolds

July 26, 2018 at 5:57 pm

An ‘Expert Panel’ On Medicinal Cannabis Without A Single Expert On It?

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Dr Michael McBride, Chair of the Cannabis-based Medicines Expert Panel

To be fair, the members of the expert panel are hardly a surprise.  It’s the medical establishment writ large.  The chairman, Dr John McBride, was, according to Charlotte Caldwell, “instrumental” in stopping Billy’s medicine being prescribed, despite the original prescription coming from a consultant neurologist specialising in paediatric epilepsy.

A government which has denied any medicinal value in cannabis for nearly 50 years needs ‘cover’ for its long overdue U-turn.  Surely though, there needs to be at least one member of the panel who has some expertise in the subject? It’s doubtful that any of the members have ever seen a vaporiser or could tell the difference between weed, hash and a concentrate. They’d probably just call them all ‘skunk’.

Professor Dame Sally Davies, Chief Medical Officer

The intention is probably to turn ‘medicinal cannabis’ into a pill or a bottle of medicine, a nice square peg that these bureaucrats can slot into their square hole. Such servants of the status quo are incapable of considering that modern medicine might have anything to learn from traditional, plant-based medicine that has been used successfully for millennia, instead of barely a century of the simplistic, reductionist theory that they represent.  Of course it shouldn’t be a matter of either/or, we should use the best of both theories because both have much to offer to the health of the nation.

It’s instructive that Professor Dame Sally Davies managed to find “overwhelming” evidence of the medicinal value of cannabis in about 24 hours flat. The evidence has been wilfuly ignored by every government and the self-serving individuals who have held the role of Home Secretary since 1971.

It’s astonishing though that in her review, delivered at lightning speed, she’s come up with this pejorative term “grown cannabis” yet seems enthusiastic about synthetic cannabinoids on which there is precious little clinical research and strong evidence of severe, even life-threatening side effects, totally different from the natural product.

Dame Sally writes: “Cannabis has many active chemicals and only cannabis or derivatives produced for medical use can be assumed to have the correct concentrations and ratios. Using other forms, such as grown or street cannabis, as medicine for therapeutic benefit is potentially dangerous.”

Where else does cannabis come from if it isn’t ‘grown’?  It has to be synthesised in a lab. Why on earth would Dame Sally want to go down that route when no other jurisdiction enabling legal access to medicinal cannabis has done so? Bedrocan products are grown specifically for medical use and standardisation of “correct concentrations and ratios” is exactly what the company is focused on.

This is a clash between two different approaches to medicine which, as I say should be regarded as complementary, not contradictory but we cannot possibly move forward if the only ‘experts’ have no expertise!

To be fair, this is all unfolding at breakneck speed.  Imagine Theresa May hovering in the wings, the hard line prohibitionist eager for any opportunity to kick this back into touch. As it stands, the expert panel will fail, it’s bound to.  We have to give Dame Sally a chance to adjust to the new reality.  With the assistance of Professor Mike Barnes, CLEAR will be keeping a close watch on progress and we will keep Dame Sally apprised.  We have already written to her twice this week setting out our concerns and we will do so on a regular basis.

 

 

 

 

Written by Peter Reynolds

July 5, 2018 at 7:06 pm