There are growing calls for wider access to medical cannabis, but a lack of hard evidence surrounding its safety means many doctors are unwilling to prescribe without randomised controlled trials.
In November 2018 new UK legislation came into force making cannabis-derived medicinal products available on prescription by a limited number of specialist doctors.
The move meant cannabis changed from a Schedule 1 classification under the Misuse of Drugs Act 1971 (MDA) – which includes drugs not used medicinally such as LSD and ecstasy – to Schedule 2, which includes opiates like morphine and methadone that can be prescribed under strict regulations.
The change was welcomed by patients, campaign groups and industry who say cannabis-based medicinal products (CBMPs) offer new ways to treat anything from genetic disorders to childhood epilepsies, multiple sclerosis (MS), psychiatric conditions and even chronic musculoskeletal or cancer pain. Furthermore, this new route enables the doctors concerned to prescribe medicines which have not yet been authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) – as noted below, only two products, Sativex and Epidiolex, both produced by GW Pharmaceuticals, have received MHRA marketing authorisations so far, following a lengthy, and expensive, authorisation process.
The change in law came after ministers were made aware of the plight of children such as Alfie Dingley, whose families had long campaigned to allow NHS doctors to prescribe medical cannabis to treat their severe types of epilepsy.
Global growth industry
While the UK medical cannabis market is embryonic, production and research is a global growth industry, with entrepreneurs expecting significant returns. By 2025 the worldwide medicinal cannabis market is projected to be worth anything from £33.64bn, (according to research firm Research and Markets), to £62.6bn (according to Prohibition Partners) which provides intelligence on the cannabis market).
While the UK CBMP industry is small, it is significant. In 2010 the MHRA authorised Cambridge- based GW Pharmaceuticals’ Sativex oral spray as an add-on treatment for symptom improvement in patients with muscle spasms and stiffness due to MS.
Sativex contains two active ingredients derived from the cannabis plant – CBD and tetrahydrocannabinol (THC). THC raises concerns as it is the main psychoactive component of marijuana which gives the ‘high’ and has been linked to agitation, hallucinations and paranoia.
Potential complications
The Royal College of Psychiatrists said in a statement issued in November 2019: “The propsychotic and anxiogenic properties of THC mean that CBMPs containing THC are unlikely to be helpful for any psychiatric condition. If such products are prescribed in other health settings, clinicians must be aware of potential psychiatric complications.”
The National Institute for Health and Care Excellence (NICE), which produces drug and treatment guidelines for the NHS, had ruled out Sativex on cost-effectiveness grounds. But in November 2019, after negotiating a hefty discount, it approved Sativex, and another GW Pharmaceuticals drug, Epidiolex.
With concerns about psychiatric complications and other factors in mind, NICE ruled that Sativex may only be used to treat spasticity – in which muscles are continually contracted – in MS. Epidiolex, whose main active ingredient is CBD, may only be used to treat two types of severe epilepsy, Lennox Gastaut syndrome and Dravet syndrome, which cause multiple seizures. Campaigners were disappointed, however, that NICE ruled out either drug for chronic musculoskeletal or cancer pain due to lack of evidence of efficacy.
While doctors on a specialist register have been allowed to prescribe unlicensed CBMPs as a ‘specials medicine’, which can be prescribed to just one specific named patient, since November 2018, figures provided in response to a Parliamentary Question in June 2019 reveal that they account for fewer than 250 prescriptions a month.
Unmet patient needs
NHS GP Dr Leon Barron believes that GPs are uniquely positioned to prescribe medical cannabis for patients with an unmet clinical need and that cannabis-based medicines should be treated in a similar fashion to any other prescribed unlicensed medications. He believes these treatments should be available through the NHS and that an evidence base made up of observational data can be built in real time whilst serving the most in-need patients. General Practitioners make up a significant proportion of prescribers in the 50+ countries where cannabis for medical use has been made legal and are prescribing for a wide range of conditions.
“Looking at data from overseas, cannabis-based medicines seem to be a really useful tool to help some patients improve overall quality of life and symptom control,” he says.
But Dr Barron says many NHS trusts reject requests to prescribe on cost grounds. “Patients who can afford it have been forced to pay hundreds of pounds or more a month for private prescriptions. Costs have been disproportionately high because up until very recently, cannabis- based medicines have needed to be imported on a named patient basis. It is known as a ‘specials medicine’ which requires Home Office licences and approval by the MHRA, and doctors are only allowed to prescribe 28 days’ worth under controlled drugs regulations.”
Hannah Deacon became a passionate advocate of CBMPs following her successful fight to get NHS treatment for her eight-year-old son, Alfie. She says medical cannabis suffers as a result of the ‘demonisation’ of cannabis in general.
She says: “We must accept medical cannabis as exceptional as it does not fit into a pharmaceutical model. Until this is accepted, and a new framework is developed and research is carried out based on a real world data approach, we will struggle to move forward.
If patients are currently on private prescriptions of medical cannabis and they show huge improvement, NHS doctors should be supported through more balanced guidance from NICE and feel able to prescribe; currently that is not happening.”
In July 2019 the House of Commons Health Select Committee issued a report on medical cannabis which called for the Government to act swiftly to support more trials, including large scale Randomised Controlled Trials (RCTs). These are seen as the gold standard in terms of assuring safety and efficacy, but the Select Committee also welcomed smaller, faster and more nuanced trials with patients who are already seeing benefits.
NHS England has listened to patients and clinicians, and in August 2019 produced a report looking at barriers to accessing CBMPs which made a series of recommendations around guidelines on usage. It also called for further research, led by the National Institute for Health Research (NIHR), with the aim being to engage with parents and clinicians who have argued for observational trials, not just RCTs, to “explore all ways to improve the evidence base”.
Dearth of hard evidence
But in the meantime, most doctors are reluctant to prescribe unlicensed products for which there is a dearth of hard evidence.
Professor Andrew Goddard, the President of the Royal College of Physicians, says a meta- analysis of the limited number of RCTs of medicinal cannabis around the world showed a measurable benefit “of around 3mm on a 100mm pain scale.”
In October 2018, the College produced guidelines on the limited use of medical cannabis with the Royal College of Radiologists and the Faculty of Pain Medicine of the Royal College of Anaesthetists.
“If medicinal cannabis was entirely safe and cost 10p per pop,” Professor Goddard says, “it would be used fairly freely in the NHS. But when you have drugs costing £10,000 a year per patient, the benefits would have to be pretty compelling in order to make it cost-effective."
The MHRA’s authorisation made Sativex the first natural cannabis-based derivative to gain market approval in any country. Worldwide sales of Sativex have promoted GW Pharmaceuticals to number two in the top ten cannabis firms in the world by market capitalisation. The business is currently valued at around $3.6bn, according to the Prohibition Partners report.
Public health imperative
George McBride, chief executive at Hanway Associates, a strategic consultancy working with the cannabis industry, says there is a “public health imperative” to ensure access to safer and cheaper domestically grown products, and calls for Government backing in terms of financial and other support for industry and research.
Unlike other countries that have reformed their laws, McBride says the UK is trying to shoehorn medical cannabis into its “existing model of healthcare through existing pharmaceutical standards and healthcare channels – that is not what other countries have done.” And he reiterates calls for reassurances that the UK Proceeds of Crime Act 2002 (POCA) would not apply to legitimate UK firms doing business with legitimate cannabis companies abroad.
McBride says that while the licensing system treats CBMPs like unlicensed new pharmaceuticals which are “for good reason” tightly restricted, “in this case we have a product where the lions’ share of patients are already obtaining it from the black market”.
