Professor Mike Barnes has said that the draft guidance from the National Institute for Health and Care Excellence (NICE) on cannabis-based medical products (CBMPs) is “appalling”.
Published this week, NICE claims there is not enough evidence to recommend CBMPs as an alternative to established drugs, even in the case of severe treatment-resistant epilepsy. NICE called for more trials, but says patients with chronic pain should not be offered medication that uses tetrahydrocannabinol (THC) or mixtures of cannabidiol (CBD) and THC, unless the treatment is part of a clinical trial.
Barnes, who has set up two organisations in Britain to educate doctors about cannabis medicine, said the guidance would make it more difficult for doctors to issue prescriptions for cannabis, meaning the chance of that happening has “now diminished even further, to basically zero”.
In June, a UKCSC Freedom of Information request to the Medicines and Healthcare products Regulatory Agency (MHRA) revealed that only 87 prescriptions for cannabis-based medicines had been applied for since the law change last November. Only three have been prescribed by the NHS.
Barnes criticised NICE’s reliance on evidence from randomised controlled trials (RCTs), which as he has previously explained, cannot be applied to something like cannabis, which unlike compound pharmaceuticals is a family of medicines.
He added: “We do need more evidence – no-one’s ever said otherwise. But to say there’s not enough evidence to even think about prescribing it is appalling and to the huge disadvantage of hundreds of thousands of people in this country.”
In a press release issued alongside the guidance, Paul Chrisp, director of the centre for guidelines at NICE, said: “We recognise that some people will be disappointed that we have not been able to recommend the wider use of CBMPs. However, we were concerned when we began developing this guidance that a robust evidence base for these mostly unlicensed products was probably lacking.”
Meanwhile, NHS England and NHS Improvement have also published a report into current barriers to NHS prescription of CBPMs.
It concluded that “if CBPMs are to be routinely commissioned across the NHS, the science and the evidence base supporting use needs to be significantly better developed”.
Among ten recommendations in the NHS report, it says that although evidence for the use of CBPMs in severe treatment-resistant paediatric epilepsy should be generated though RCTs, an “alternative study design” should be considered to “enable evidence generation for those patients who cannot be enrolled into a standard RCT”.
The report also noted that the high cost of CBPMs, as well as the time consuming process of importation, may have created a barrier to access. It calls on NHS England and NHS Improvement to work with suppliers “to ensure that sufficient stock of good quality CBPMs are available and that the products available offer the best value for the NHS”. The report suggests that UK-based manufacture of CBPMs would help to overcome this.
Keith Ridge, chief pharmaceutical officer for England, led the NHS report with Stephen Powis, national medical director of NHS England.
Ridge said that “without sufficient evidence to help them balance potential benefits against potential harms when they are deciding whether to prescribe medicinal cannabis to children with very severe epilepsy, it is clear clinicians are very reluctant to prescribe”.
“We heard loud and clear the concerns and frustration the children’s families are feeling, but these recommendations aim to help us develop the evidence base to understand how safe these products are, and ensure education and expert advice is available to support clinicians across the UK.”