A Drug Science response to the Advisory Council on the Misuse of Drugs (ACMD) Report:
Cannabis-based products for medicinal use (CBPMs) in humans (November 2020)
In February 2019 the then-Home secretary commissioned the ACMD to conduct a longer-term review of cannabis-based products for medicinal use in humans. The aim was to assess the impact of rescheduling (in November 2018) cannabis-based products for medicinal use (CBMPs) to Schedule 2 so this report marks two years since the restoration of cannabis as a medicine under British law.
Drug Science welcomes this new ACMD Report on CBPMs in humans and agrees that data collection on the impacts of re-scheduling CBPMs continues to prove challenging because of the lack of homogeneity in data collection across each administration in the UK and across different sectors (NHS and private).
In the UK, there is a perceived lack of safety and efficacy data for many unlicensed CBPMs by the medical profession; yet in many other countries globally, these medicines have been successfully prescribed to large numbers of patients, where cannabis has been shown to have an excellent safety profile.
Whilst we agree that the clinical evidence generated through randomized controlled trials (RCTs) is strong for the three licensed cannabis-based medicines (Sativex, Nabilone, Epydiolex) which are now available in the UK and approved by the National Institute for Health and Care Excellence (NICE) for four main conditions, we would like to highlight three main concerns:
1. Patients globally are successfully using various CBPMs for a much broader range of indications than the limited conditions recommended by NICE. In all databases and surveys, pain (chronic and neuropathic) is the condition most frequently treated with CBPMs, followed by psychiatric conditions, including anxiety and depression. We suggest that these global findings ought to be taken into account in addition to the RCT evidence. A peer reviewed article detailing this Real World Evidence (RWE) has been prepared by Drug Science for publication in 2021.
2. RCTs are not the only, or indeed the best path to evidence collection on CBPMs. Please see e.g. Nutt et al. (2020) for further details, including ways of how to incorporate RWE in policy making.
3. The range of licensed products in the UK is too limited for many patients, who would benefit much more from different products. Drug Science has collated evidence from 20 children with treatment-resistant epilepsies to support their use of Bedroccan/Bedica/Bedrolite, rather than Epydiolex. Some of these patients who were treated successfully with these unlicensed products, had to revert to a less effective CBPMs due to cost reasons, causing their children’s seizures to return. No parent should have to do this. Whilst there are options of private prescriptions, as the ACMD reports, costs are prohibitive for most of these families with a chronically ill child. A peer reviewed article incorporating these case studies is currently in press (Zafar et al., In Press).
Drug Science strongly agrees with the ACMD conclusion that the development of a CBPM patient registry is a crucial step in allowing for a careful analysis of the extent and pattern of prescription of CBPMs and their benefits and risks. This is why in 2020 Drug Science launched Project TWENTY21, aiming to collect data of up to 20,000 medical cannabis patients over the next two years. Details of our project and its contributors can be found here.
We hope that our CBPM patient registry will provide the evidence for CBPMs in the UK. We have had discussions with the government about our vision and have offered to support and interact with the Government’s registry and to be able to collate both private and NHS prescription data.
Further, it is essential that the National Institute for Health Research (NIHR) funds research into the medicinal use of cannabinoids, licensed cannabis-based medicines and unlicensed CBPMs, so that peer-reviewed research can continue to determine the benefits and harms of these products. Drug Science will publish the first peer reviewed article on the initial findings of Project TWENTY21 early next year and will continue to contribute to this vital task over the coming years.
In addition to the benefits and harms of CBPMs, Drug Science has also done (and continues to do) research on the regulation of medical cannabis. In 2019, Drug Science published a review of international approaches to legislation facilitating the medicinal usage of cannabis-based medicines. The full report and peer reviewed article can be found here.
Since developments in both medical cannabis science as well as regulation have been rapid in 2020, we welcome the suggestion of an updated regulatory report.
Regarding the impacts on public knowledge and attitudes towards cannabis and CBPMs, and on professional education, Drug Science suggests looking to Canada and the US for increasing evidence indicating that the rescheduling of CBPMs has not had a negative impact on the prevalence of illicit cannabis use (please see e.g. https://www.cdc.gov/pcd/issues/2020/20_0156.htm)
In agreement with the ACMD report, Drug Science welcomes (and can contribute to) further research to assess the impacts of the UK rescheduling of CBPMs on public knowledge and attitudes towards medical cannabis and to explore the safety, quality and efficacy of unlicensed CBPMs, licensed CBPMs and licensed cannabis-based medicines so that these medicines can reach patients in need.