The Conservative Drug Policy Reform Group (CDPRG): Part B of the UK Review of Medicinal Cannabis
NeuroSight has provided CDPRG with written evidence on medicinal cannabis based on in-house research. Evidence outlines recommendations and opinions on policy objectives, the current regulatory framework, policy changes and standards of evidence.
Other than the three policy goals identified in (2) above [safe access, evidence generation, risk minimisation], what primary objectives do you think should be prioritised by policymakers?
Information dissemination: What impact could this policy choice have on the knowledge of healthcare professionals regarding how to prescribe cannabis-based medicinal products?
The regulations on medical cannabis in the UK are extraordinarily liberal making no restrictions on eligible conditions or sourcing of unlicenced products, yet most doctors are resistant to prescribing medical cannabis over one year after its legalisation. This is because the current policy is designed to give doctors the discretion to prescribe CBPMs, instead of integrating them into the medical practice with the right resources for doctors to prescribe with confidence.
One of the key obstacles to the successful implementation of the medical cannabis policy is the lack of education of health professionals on this topic. The cannabis plant has been used medicinally for thousands of years but the discovery of the endocannabinoid system was only around 1992.[1] This means that most specialist doctors already graduated from medical school by the time it was discovered. Therefore, they did not receive formal training about the role of this system in the body and how it relates to diseases. In fact, anecdotal evidence indicates that doctors in senior positions greatly resist the use of medical cannabis, while junior doctors show a lot more interest.[2]
Research carried out at the University of Glasgow School of Medicine with the involvement of Drugs and Me and NeuroSight shows that 89% of medical students agreed or strongly agreed with the statement that they are aware of cannabinoids as a class of drug and their general characteristics. Although this study was limited regarding its generalisability due to its small sample, it suggests that current medical students are proactive in learning about cannabinoids despite the lack of cannabinoid pharmacology in the medical curriculum. Still, this study only measured the ‘perceived’ knowledge of medical students and a lack of standards when it comes to cannabinoid pharmacology is concerning.
An e-learning package by NHS England,[3] and a CPD course by The Academy of Medical Cannabis[4] are now available, however not all doctors are aware of their existence. Yet, the dissemination of knowledge on medical cannabis to all healthcare professionals is very important because the prescription of CBPMs is not up to individual doctors as the prescription of unlicenced medicines has to be cleared by local governance bodies. Senior professionals also need to understand medical cannabis to support the prescription.
Although generating more evidence will contribute to the confidence of health professionals to prescribe or approve CBPMs, having a sufficient and good quality evidence base does not necessarily translate into its acknowledgment. Therefore, dissemination of the available information on CBPMs should also be prioritised by policymakers.
Which Government department do you think is best suited to be responsible for cannabis policies?
Department of Health and Social Care. The fact that the Home Office is currently responsible for cannabis policies creates the perception that cannabis is a dangerous street drug that needs to be criminalised. In fact, its scheduling defines cannabis as a drug with high risk of abuse and no therapeutic value. On the other hand, the legislation states that cannabis-based products have medicinal value for various conditions. This is confusing, as these two narratives contrast with each other causing barriers to the integration of cannabis into medical practice. The negative connotations of cannabis lead to the over-perception of its related risks, especially in comparison to its benefits. What’s more, this situation can result in the stigmatisation of patients by their doctors when patients demand medical cannabis.[5]
Does the current regulatory framework for the manufacture, importation, distribution, supply, prescription and use of licenced CBM (e.g. Sativex) and unlicenced CBPM (e.g. Bedrocan products):
Provide safe and affordable access where clinically appropriate?
Contribute to the development of the evidence base on product safety, quality, efficacy and/or effectiveness? Effectively minimise risks and harms to individuals and to society?
Otherwise meet the needs of policymakers, regulators, prescribers, patients, producers and/or other industry stakeholders?
The current regulatory framework gives health professionals the discretion to prescribe CBPMs, leaving them with a lot of liability in terms of the safety and wellbeing of patients. Consequently, health professionals prefer not to prescribe, nor approve a prescription because of the gaps in the evidence, and the contrasting narratives surrounding cannabis, which has predominantly presented cannabis as a harmful street drug. This preference is a professional choice as they act according to their professional ideologies which is not doing something that has a potential to harm. In turn, health professionals’ reluctance to use their discretion has been legitimised within the professional community.
Only specialist doctors can prescribe CBPMs, and the prescription of unlicenced products (i.e. specials) needs to be cleared by local governance structures where senior clinicians act like gatekeepers. As it’s mentioned above (3-5), most senior health professionals had not studied cannabinoid pharmacology at school and it’s likely that they haven’t completed the e-learning package or the CPD course which were available only recently. Since they are less likely to be aware of or convinced by the efficacy of CBPMs, this places further barriers against the accessibility of CBPMs.
Unlicenced CBPMs are much less likely to be prescribed compared to licenced products (table 1) and most CBPMs are still unlicenced in the UK. The report by the Health and Social Care Committee[6] complains about how the industry should take more initiative if they want their products to be licenced and prescribed. However, undertaking research with CBPMs is very expensive and does not necessarily pay off because of the difficulties in obtaining a patent for cannabis-based products.[7] Furthermore, the industry might think that their unlicenced products will eventually be prescribed anyways because of the patients’ needs and demands. Meanwhile, businesses can generate revenue by selling their products abroad which means that they have less incentive to collaborate with the health sector in the UK.
Doing research with the cannabis plant itself, which is necessary to exploit its full potential for novel drug development, is even harder because the cannabis plant is still in Schedule 1. This causes research costs to be ten times higher compared to studying an uncontrolled drug[8] and bureaucratically more difficult in terms of obtaining necessary licences and product supply. Therefore, the current framework doesn’t only hinder the research necessary to prove the efficacy and safety of unlicenced products, but also the research that could produce potentially more effective products which could be less harmful to patients.
Table 1. Number of prescriptions by the NHS[9]
Our survey[10], which was conducted in April 2020 to understand the impact of COVID-19 on recreational drug use, provides some insights on people’s motivations for illicit cannabis use as well as their potentially unmet needs of medicinal cannabis. The results show that 47.8% of people who have ever taken cannabis in the UK were using it every day (Figure 1), and that 51.8% of everyday-users were using illicit drugs to self-medicate (Figure 2). Our data cannot answer whether they were using cannabis or other drugs to self-medicate, however, the everyday use strongly suggests that they were self-medicating with cannabis. The astonishingly high numbers regarding self-medication might be due to the consequences of the pandemic. Still, our findings suggest that people already use cannabis medicinally without professional supervision.
Furthermore, of those who were smoking cannabis every day and reported self-medicating, most reported self-medicating to alleviate anxiety, insomnia and symptoms of depression (Figure 3). This suggests a demand for these conditions to be better treated, potentially due to a lack of alternative treatments that are effective or that have less side effects. While the current guidelines do not recommend CBMPs to treat anxiety, insomnia or depression, our data suggests that cannabis might help treat these conditions. This calls for the urgent improvement of regulatory frameworks that allow access to more people to treat a greater variety of conditions.
Finally, our findings show that people who use cannabis more frequently are more likely to use illicit drugs for self-medication (Figure 4). This relationship suggests that people whose medical needs are not met by other treatments end up self-medicating with illicit cannabis. This is concerning, since cannabis obtained from the illicit market and consumed without medical supervision leads to more risk and harm for the individual.
If you think the current policy on cannabis-based medicines and products for medicinal use does not satisfactorily achieve any of the above, what policy changes do you think should be considered to improve outcomes?
Facilitate the research process: The Home Office should consider moving cannabis plant from schedule 1 to 2, which would allow researchers to study the plant’s full potential without high costs and complicated bureaucratic processes. If the Government has reservations about this option, the licence fees to study cannabis for medicinal reasons, not recreational reasons, should be discounted and a fast track scheme to obtain such licences should be offered.
Explore the knowledge and attitudes of healthcare clinicians: Clinicians’ views on cannabis is essential for the successful implementation of medical cannabis policies. By conducting a survey, NHS England can monitor their knowledge and attitudes about medical cannabis. Alternatively, more studies like the one we carried out (4) can be used to inform the design of other policies.
Educate healthcare professionals: NHS England should ensure that all clinicians are aware of the existence of the NHS e-learning package and the CPD course on CBMPs. Furthermore, health professionals should be encouraged to complete these programmes. Cannabinoid pharmacology should also be included in the medical curriculum by the General Medical Council.
Encourage champions to speak up: Healthcare champions, especially private clinics, can play the icebreaker role in prescribing medical cannabis. The medical community would respond to its own members better than it would to patients or politicians. These champions should be encouraged and supported to speak up, in which the media can play an important role. The results of new research and outcomes of prescriptions should be shared transparently. Transparency shows that champions are confident in their actions and can face criticism, which will undermine the legitimisation of not prescribing medicinal cannabis.
In particular: As compared to other medicinal products, should a lower or otherwise different standard of evidence be required of cannabis-based products for: market authorisation in the UK; evaluation of cost-effectiveness; or prescribing decisions?
A different or lower standard of evidence should be required of cannabis-based products for market authorisation and prescribing decisions in the UK. Both market authorisation and prescribing decisions are different ways of risk regulation. The current regulatory framework focuses on the so-called ‘known knowns’ and ‘known unknowns’, in other words, the risks and benefits for which clinical evidence already exist, and evidence on areas we know is missing such as the efficacy of a product for a certain condition. The current framework is also designed to be precautious towards the ‘unknown unknowns’, which are especially challenging uncertainties to deal with during a stereotypical drug development process as they refer to the risks that are unknown to us.
Cannabis-based products differ from other medicinal products at a very fundamental level. They are not entirely new chemicals that are developed in the lab and given to patients for the first time. Cannabis has been used for many years and any severe or rare risk would have emerged throughout this time or be detected by studies that investigated its recreational use. Hence, cannabis-based products have relatively fewer ‘unknown unknowns’, meaning that their regulatory framework can afford to be less precautious. Accordingly, standards of clinical evidence can be lowered, particularly for conditions that can be life-threatening or where the alternative treatment has severe adverse effects such as epilepsy.
The dependence on randomised controlled trials (RCTs) for the development and assessment of evidence base gives rise to ethical and practical problems. Generating all necessary evidence through RTCs is a slow process that takes years to conclude. Denying access to a treatment that might prevent deaths or significantly reduce harm, which can be due to the disease itself or its available treatment, while waiting for results is not ethical, especially when the product is known to be efficacious because patients tried it elsewhere. Similarly, giving a placebo treatment in this case faces the same ethical dilemma.
The use of RCTs is also practically problematic. Cannabis is a very complex plant and its efficacy depends on the combinations and ratios of its very diverse chemical content. The ideal combinations and ratios of these compounds are different for every condition, and they even can be different for every patient with the same condition. Hence, finding out the ideal product through RCTs to prove that a certain cannabis-based product has a better risk/benefit ratio than an existing treatment is practically not feasible.
As our data shows (Figure 3), people are already using cannabis to medicate different conditions. These illicit users are likely to have the knowledge on the strains of cannabis, administration routes and dosing schedules that work the best for their conditions. Such knowledge should not be ignored while developing the evidence base of CBMPs.
The current regulatory framework can be improved to acknowledge these “unknown knowns”. Scientists are discovering ways of how to most reliably and rigorously utilise this knowledge that already exists regarding which strains, dosing schedules or administration routes are most effective. For instance, a micro-dosing study on psychedelics has designed a methodology that allows self-blinding and the use of placebos for use at home.[11] In this context, evidence from self-medication studies should be allowed to inform decisions about market authorisation and prescription. Requiring clinical trials to meet certain standards that can be derived from real-world data wastes the resources of both the public and private sector, and withhold treatments from patients which can be more beneficial or less harmful for their conditions.