UK Must Embrace Medicinal Cannabis, Say Experts
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It is time for the UK to change its attitudes towards medicinal cannabis, according to scientific experts from Imperial College London, the London School of Economics, and the independent scientific body Drug Science.
Writing in BMJ Open, the experts argue that the current concern over a lack of randomized controlled trial evidence supporting cannabis-based products for medicinal use (CBPMs) is “misplaced” given the wealth of patient-centered evidence available.
Barriers to accessing medical cannabis
Medical cannabis has been legal in the UK since November 1, 2018. Following that decision, it was widely assumed that CBPMs would quickly find their way into the National Health Service (NHS) and become available to the patients who require them.
Instead, in the nearly two years since the legalization of medical cannabis, only a handful of CBPMs have been prescribed on the NHS and zero NHS prescriptions have been written for full-extract cannabis oils. And while some CBMPs have been prescribed privately, the associated costs for private treatment make this route unviable for many struggling patients.
General access to medical cannabis in the UK is so difficult that it is thought there are now as many as 1.4 million British adults self-medicating with illicit cannabis to treat a diagnosed medical condition.
The reasons for this hold-up are complex and multifaceted. For example, the status of CBPMs as “unlicensed specials” requires the prescriber to shoulder full responsibility should a patient react badly to their dosage. Additionally, pharmacists and medical prescribing advisors usually resist the cost implications of approving new medicines to their local prescribing lists.
But the most commonly cited reason for this poor access situation is a notable lack of “gold standard” double-blind randomized controlled trials (RCTs) that have proven the therapeutic value of CBPMs.
Recognizing a more patient-centered approach
In their article, the British experts argue that, yes, while there may be relatively few RCTs into medical cannabis compared to some other medications, that does not mean that CBPMs should be dismissed out of hand. Instead, they ask that doctors and prescribers consider patients’ lived experiences when evaluating the effectiveness of cannabis medicine.
“While tens of thousands of individual patient reports of the therapeutic value of CBPMs as in the Canadian and Minnesota databases do not equate to the so-called gold-standard double-blind randomised controlled trial level of proof, they are highly suggestive of a pattern of evidence which should be taken seriously rather than summarily dismissed,” the authors write.
They propose that the patient information contained in these large-scale databases could be further analyzed to collate “patient-reported outcomes” and other metrics that might evidence the effectiveness of CBPMs. While these data wouldn’t be specific to Britain, they do note that Drug Science’s recently launched Project TWENTY21 – the largest medical cannabis registry in Europe – is aiming to soon create a structured body of evidence on medical cannabis using British patients.
The experts claim that prescribers are often placing too much importance on randomized trial data.
Quoting a 2008 speech from Sir Michael Rawlins, then-chair of the National Institute for Health and Care Excellence (NICE), they highlight that: “Randomised controlled trials (RCTs), long regarded at the ‘gold standard’ of evidence, have been put on an undeserved pedestal. Their appearance at the top of ‘hierarchies’ of evidence is inappropriate; and hierarchies, themselves, are illusory tools for assessing evidence. They should be replaced by a diversity of approaches that involve analysing the totality of the evidence base.”
They also point out the existence of more than 50 medicines licensed by either the US Food and Drug Administration and/or the European Medicines Agency that did not present RCT data, countering the often mistakenly-held belief among prescribers that they cannot prescribe medications without such trials.
Overcoming the access barrier
Individual patient cases, such as those of Billy Caldwell and Alfie Dingley, played a large part in the UK government’s decision to amend the law and legalize medical cannabis. Here, these patient-reported outcomes served as a powerful demonstration of the effects CBPMs can have on certain conditions.
If such patient-centered approaches can become more widely accepted by prescribers within the medical community, the experts believe they could go a long way towards improving the ease of access to CBPMs. In addition, the establishment and roll-out of medical cannabis education programs, such as those offered by Drug Science or The Academy of Medical Cannabis, could also prove essential in improving prescriber knowledge and confidence when working with prospective medical cannabis patients.
“The failure of the medical and pharmacy professions to embrace CBPMs despite their being made 'legal' over 18 months ago is a great worry to patients,” the experts conclude.
“We hope that this paper will help policymakers and prescribers understand the challenges to prescribing and so help them develop approaches to overcome the current highly unsatisfactory situation.”