Today (13th August 2019), the independent scientific body Drug Science has responded with disappointment to a decision by the National Institute for Health and Care Excellence (NICE), relating to cannabis-related medical products.
In November 2018, the then Home Secretary Sajid Javid introduced regulations so that cannabis-derived medicinal products would be available on prescription. This change followed high profile cases of children with intractable epilepsy being denied access to cannabis oil, in order to control their seizures (including those of 12-year old Billy Caldwell and six-year old Alfie Dingley).
However, last week – on 8th August 2019 – NICE published its draft recommendation on the use of cannabis-based medicinal products for such cases, stating it was ‘unable to make a recommendation about the use of [such medicines] for severe treatment-resistant epilepsy because ‘there was a lack of clear evidence that these treatments provide any benefits’. (1)
Drug Science questions both NICE’s decision and this statement. The chair of the organisation’s scientific committee, Professor David Nutt says:
“This is very disappointing for the tens of thousands of patients and carers having to break the law every day to obtain black-market medical cannabis, which puts them at risk of criminalisation and into contact with more harmful forms of cannabis, such as ‘skunk’ and ‘spice’.”
Professor Nutt also questions the fact that NICE’s decision has been based, to a great extent, on Randomised Control Trials (RCT) that use placebo (with some patients being given a cannabis-derived medicine and others not).
“The total reliance on placebo-controlled RCT trial data by NICE reveals a deep lack of appreciation of the complex and varied nature of medical evidence. Sir Michael Rawlins, the previous head of NICE, and the Medicines and Healthcare products Regulatory Agency (MHRA) made this clear when he previously stated that RCTs ‘have been put on an undeserved pedestal’ and described them as ‘illusory tools for assessing evidence.”(2)
Professor Nutt argues that;
“Clinicians want to practice evidence-based medicines and do what is best for their patients. That’s why patient experience and effectiveness trials are vital for a proper understanding of the real-world value of medical cannabis. NICE should have taken these into account, as the Health Minister Matt Hancock said to the Health Select Committee only last month. This failure of mature and balanced leadership from the Department of Health is very distressing.”
In September 2019, Professor Nutt and the charity Drug Science will be launching its own ‘real-world data’ research pilot project into the prescription of cannabis-based medicinal products. By studying the health, lives and experiences of 20,000 patients, it will help to develop a body of evidence, using real-world data to document efficacy of such medicines, their safety and patient reported outcomes.
NOTES TO EDITORS
For more information on this release, and on Drug Science’s work, please call Elliot Elam on 07984 406512.
About Drug Science
Founded in 2010, Drug Science is the leading independent scientific body on drugs in the UK. We work to provide clear, evidence-based information without political or commercial interference.