Last week (8th August) NICE published their latest thoughts, based on an NHS England review, on prescribing medical cannabis. And much to the disappointment, anger and frustration of campaigners the only group of sufferers for whom they approved the prescribing of medical cannabis was adults with chemotherapy-induced nausea and vomiting which hasn’t responded to conventional licensed medicines.
The use of the licensed product Sativex for treating spasticity in people with MS was regarded as insufficiently good value to be licensed – while the committee were unable to make a recommendation about the use of cannabis-based medicines for severe treatment-resistant epilepsy because there was a lack of clear evidence that these treatments provide any benefits.
Both NHS England and NICE’s objections were based on the lack of evidence about the long term safety and effectiveness of medicinal cannabis – and the report calls for clinical trials to be set up. But…..
What sort of evidence are we talking about here?
In their report NHS England state that:
The vast majority of the clinicians we spoke to told us that the lack of good quality randomised control trial (RCT) data demonstrating adequate safety and clinical-cost effectiveness of CBPMs for all indications is a major hurdle to prescribing.
Surprise, surprise.
- Since medical cannabis was illegal until November of last year, there have been no RCT trials so it is no surprise that there are none demonstrating safety and cost effectiveness. You cannot get the evidence without the trial.
- In any case, RCT trials are designed to test single substances. Medical cannabis plants contain over a 100 compounds which work synergistically together. While it is possible to isolate individual compounds such as CBD or THC (and CBD compounds have been isolated and subjected RCT trials), it is using the whole plant that delivers the most effective results. RCT trials are not designed to test the whole plant.
But meanwhile, what about case studies and anecdotal or observational evidence? Does the experience of those who have used medical cannabis and have derived significant, indeed sometimes life changing benefits from it, count for nothing?
Childhood epilepsy
Almost every week newspapers carry stories about children with rare forms of treatment-resistant epilepsy whose seizures have been all but eliminated by the use of medical cannabis. Without cannabis these children not only have up to several hundred seizures a day but have a significantly higher risk of sudden unexpected death. Even when they do not cause sudden death, some of the non-cannabis treatments on offer are thought to shorten life expectancy without delivering any significant benefit.
Multiple sclerosis
The MS Society says that one in five of its members uses cannabis to help ease pain and stiffness. Given that they are currently having to pay thousands of pounds to get it, surely that would suggest that it works and that maybe NICE should therefore be looking for some way to fund it that would be more cost effective.
Pain control
As with MS, patients are prepared to spend up £1500 a month to buy ‘illegal’ cannabis because it reduces their pain and their need to take opioids. Indeed, evidence suggest that 25% of those taking opioids for pain relief have been able to dramatically reduce, if not eliminate, their use of opioids once they started taking medical cannabis.
Given the current crisis over the use of opioids, is that not enough on its own to suggest that a wider use of medical cannabis would be desirable?
Education rather than – or at least in parallel with – clinical trials.
Effectively, clinicians were telling NHS England that they did not know enough about medical cannabis to prescribe it. Perfectly reasonable objection. So might a better approach not be to combine a serious educational programme for potentially prescribing doctors with some further trials? At least that would move the process forward. Waiting for trial results before moving forward could a delay of five years or more.
(Clinicians wanting to know more now should check in with the Medical Cannabis Clinicians Society who provide ‘high quality, balanced education and expert support in order to inform clinicians about the current state of evidence with regard to the efficacy of cannabis and its side effects.’)
And of course there is also the safety issue
It is perfectly reasonable – and indeed right – for NHS England and NICE to be cautious about licensing new drugs – and let us for the sake of this argument accept medical cannabis as a drug. However they seem to be being unreasonably cautious about a plant based medicine which presents very little in the way of risk. Unlike many of the drugs, especially the pain killing drugs, that clinicians are currently prescribing.
Medicines, even when they have been through every RCT trial under the sun, are not always safe. Indeed, far from it. The UK Office for National Statistics reported that in 2018 in the UK alone, around 4,000 people died from taking opioids. In the US more people are now dying each year from using prescription drugs than were killed by the Aids epidemic at its height.
Medical cannabis (as opposed to recreational cannabis) is very safe and is not known to have ever killed anyone. It also apparently offers very significant benefits to those who use it.
One really has to ask to what extent NHS England and NICE are being leant on by the drug companies whose products could be pushed off the shelves were medical cannabis to be licensed on a wider scale.
For NHS England’s full report see here. For NICE’s recommendations see here. For the consultation – it is open until 5th September if you want to have your say– see here.
If you want to learn more about medical cannabis, try Professor Mike Barnes’ Beginner’s Guide available as an ebook or in print at Amazon here.
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