The hearing consisted of a committee of MPs:
Dr Sarah Wollaston (Chair)
Dr Philippa Whitford
Dr Paul Williams
Three panels of “experts” were giving testimony.
The first of these comprised Alette Addison, NHS England and Professor Dame Sally Davies, Chief Medical Officer for England. This session was mostly Sally, explaining her role, limited as it was to rescheduling and setting out the lamentable nature of CBMP trials to date. The key takeaways were that there is a necessity for quality trials and in the meantime urgent patient access should be facilitated.
One aspect of this that does appear to have been missed by most reports on this session, is that whilst “Gold Standard RCTs” can cost huge amounts of money and take anything up to 3 years to complete, it is also possible that where there is obvious evidence of success (or failure), trials can be stopped on moral grounds (no longer morally correct to keep a placebo group on placebo if you can be certain that the drug being trialled would be of benefit to their health) and as such, these trials could take just a few months to complete before a medicine can be approved.
The second panel consisted of Genevieve Edwards, Director of External Affairs, MS Society, Peter Carroll, Campaign Director, End Our Pain, and Professor Mike Barnes, Chair, Medical Cannabis Clinicians’ Society
Questioning was polite and sympathetic, particularly from those of the committee with medical training, who produced reasoned arguments around the necessity for RCTs. Perhaps unsurprisingly, with the Parents of 16 children in the audience, the panel members focused almost entirely upon the immediate needs, here and now, which may have come across as a rather narrow approach as a result. In addition, both Peter and Mike were questioned by the panel of MPs at some length about conflicts of interest and sources of funding.
There was some discussion relating to the lack of prescriptions to date along with the difficulty and misinformation surrounding fulfilling them, and Mike cited the current lack of education across the medical profession as being the single biggest reason for the “slow take-up” by doctors.
Mike raised a number of excellent points around the uniqueness of cannabis as a plant based medicine which does not fit comfortably with the concept of randomised, controlled trials:
“We're trying to force medical cannabis down a pharmaceutical route, but it doesn't comfortably work. We should consider an alternative licensing model so that doctors do not have to take personal liability for prescribing medicinal cannabis”
The final panel had Dr Imran Malik (Royal College of Psychiatrists), Professor Helen Cross (Head of Developmental Neurosciences, UCL GOS Institute of Child Health) and Professor Sanjay Sisodiya, Chair of the Epilepsy Advisory Group, Association of British Neurologists.
Here the discussions centred more upon the difficulties that are encountered with CBMPs and associated risks with patients suffering from multiple symptoms. Given that the prescription of unlicensed medicines constitutes a personal risk to the prescriber and the potential for adverse drug interaction, this constitutes a major impediment to current prescriptions by specialists.
Prof Helen Cross (paediatric neurology) pointed out that CBD has always been Schedule 4, and as a result was unaffected by the changes of 2018, and as a result had enjoyed the opportunity for research, resulting in being a recognised treatment option in childhood epilepsy syndromes. The immediate relating issue now centres around the addition of THC and the dangers flagged by some research in animal models, and the need to adequately prove potential additional risk balancing benefits .
It is anticipated that CBMPs may well be effective in wider epilepsy, but since epilepsy is a symptom relating to many diseases, many unrecognised, proof is required as to where CBMPs are likely to be of use.
Also of great importance is her recognition that there are opportunities in epilepsy for the deployment of “rare disease protocols” to RCTs, that will tend to expedite future availability of CBMP treatment if successful.
It was noted that currently there is no credible evidence at all for CBMP efficacy in psychiatric conditions.
All in all, I thought the session had many positive aspects, not least of which was the informed and educated questions that the panel of MPs were asking which shows that real and measurable progress, albeit way too slowly, is being made and our medical professionals along with our parliamentary representatives are starting to learn.
That said, it does seem that it is going to take quite some time before these products will be readily available on the NHS and that the fastest and best way to get the most patients access in the shortest time will almost certainly be through clinical trials.
Rest assured that United Patients Alliance, Families 4 Access and The Centre for Medicinal Cannabis are already working with a number of licensed producers from around the world and with the National Institute for Health Research (NIHR) to get some trials designed, funded and initiated - so watch this space!
The second Oral Evidence session will take place on 26th March at 2:30 pm and will hear testimony given by:
Professor Andrew Goddard, President, Royal College of Physicians
Professor Finbar O'Callaghan, President, British Paediatric Neurology Association
Baroness Blackwood, Parliamentary Under Secretary of State
Professor Chris Whitty, Chief Scientific Advisor, Department for Health and Social Care
Nick Hurd MP, Minister of State for Policing and the Fire Service, Home Office
Dr Keith Ridge, Chief Pharmaceutical Officer, NHS England
Jon Liebling - Political Director
United Patients Alliance