Project Twenty21, Trying to Prove the Case for Medical Cannabis in the U.K.

By Oliver Bennett, Special Contributor to New Frontier Data

Project Twenty21 is a United Kingdom (U.K.)-based medical cannabis project intended to collect the country’s largest aggregation of data and evidence about the effectiveness and tolerability of medical cannabis. Monitored by Drug Science, its findings will provide evidence for NHS funding where the benefits of affordable medical cannabis treatment for eligible patients is proven to outweigh potential risks.

New Frontier Data interviewed Professor Michael Barnes, Project Twenty21’s clinical director. A consultant neurologist, Barnes is also author of The Beginner’s Guide to Medical Cannabis (2019).

“Project Twenty21 was set up in 2019 as part of Drug Science, a non-profit organisation started by David Nutt in 2009 to look at drug policy,” Barnes explained. “The biggest such trial in the world, the idea is to collect data about the efficacy of medical cannabis from 20,000 patients by the end of 2021 – although because of [COVID-19] it now looks likely to take until the end of 2022.”

With approximately 800 patients registered, the effort expects soon to top 1,000. But with a 20% increase month over month, they expect to involve between 12,000-15,000 patients by year’s end, and by the close of 2022, they may swell to 30,000-40,000 patients.

“The point of Twenty21 is to collect data that we desperately need to convince authorities and the NHS (the U.K.’s National Health Service) that medical cannabis is worth prescribing,” Barnes said. “At present there are roughly 6,000 medical cannabis patients in the U.K., and all but three rely on the private sector.”

While patients typically pay between £400-£500 a month, plus consultation fees, their being enrolled in Project Twenty21 saves them money as patient costs are typically capped around £150 a month. With a dozen medical cannabis producers operating in the U.K., Project Twenty21 is engaged with four providers of a range of flower and oil.

The companies – Bod from AustraliaKhironCellen and Lyphe Group – each pay a fee to participate in the programme, with all of the dispensing performed by about 50 doctors participating through six existing clinics which provide data for analysis every few months.

“The project is U.K.-based, but there is talk of setting it up as an international project,” Barnes explained. “As far as I’m aware, no one else is doing such a trial. The 20,000 patients with outcome measures will be a brilliant amount of real-world data, and it’ll be globally important [as] the biggest audited study in the world by a long way.”

To date, there are seven conditions being studied through Project Twenty21: chronic pain, post-traumatic stress disorder (PTSD), anxiety, multiple sclerosis (MS), Tourette syndrome, epilepsy, and substance-use disorder. Barnes estimates that those comprise approximately 85% of the program’s ordinary caseload, while Project Twenty21 wants to look at these more supported indications.

“We have to balance claims that cannabis is a wonderful cure-all, which it clearly isn’t,” Barnes explains, “but perhaps in a year or so there will be more areas it could move into: Crohn’s disease, colitis, cancer management, etc.”

While Project Twenty21 strives to provide an evidence base, “sadly, the British medical establishment is very conservative and stuck on the medical paradigm that nothing that can be brought to market without a double-blind, placebo-controlled, pharmaceutical-type study,” Barnes bemoans, noting that because of such reticence, “some of my medical colleagues actually complain to the GMC (General Medical Council) about doctors who prescribe cannabis.”

Barnes fundamentally disagrees with that approach, by asserting that cannabis is a plant with natural variability and hundreds of different components – 100 terpenes and 147 cannabinoids in 2,500 varieties of cannabis – which might all have a role. While isolates like GW Pharmaceuticals’ Sativex and Epidiolex are good, he says, a full plant is more efficacious due to the entourage effect.

“Project Twenty21 should bring oversight to quality control and licencing,” Barne said. “Like the Netherlands’ Office of Medicinal Cannabis, there’s a need for a body in the U.K. We’re setting up a Cannabis Industry Council so that we speak with one voice to the government. On 16 April, we launch a discussion paper on the U.K. cannabis industry, making a strong case to the government that post-COVID-19 and Brexit it will create a lot of jobs and generate tax income, so the money doesn’t go into the criminal fraternity. It will secure the supply chains, and make us less dependent on Bedrocan from the Netherlands.”

Barnes concedes that while the U.K. trails each Germany, Canada, and the United States regarding prescriptions, he noted that the pattern has been for medical establishments to be reluctant for two years, before softening after three years, and in years four then five seeing the benefits.

“I would be keen to see the dispensary model develop here,” he said, “with doctors approving prescriptions and dispensing to a properly trained cannabis pharmacy, which you see in some parts of the U.S. It is a better system for the patient.”

For now, Barnes said, “Project Twenty21 is trying to keep out of the recreational debate. Although it is perfectly reasonable, it muddies the medical arguments, as does CBD, which mixes medicinal properties with ‘wellness’. There’s nothing wrong with a CBD bath bomb, but it dilutes the medical message, and while 1.2 million people buy CBD for anxiety and sleep, they don’t know what dose they need, and untrained salespeople can’t tell them. We think CBD companies should be able to back up their claims.”

“The CBD industry did need regulation, but the Novel Food [Catalogue] designation is a sledgehammer to crack a nut,” Barnes said. “It has driven small artisanal and innovative companies out of business as they can’t afford it, and as a result CBD is dominated by big companies – which is a shame.”

Barnes summarizes that while it is a good thing that investment is happening, and that cannabis companies can float on the stock exchange, it remains a difficult sector.

“We were trying to open a bank account recently and couldn’t, while on the other hand we have to be careful that we don’t follow Canada and artificially inflate prices,” he said. “In the paper, we argue that cannabis needs a health economic analysis. Fundamentally, cannabis is cheaper than expensive medicines like anti-convulsants and antipsychotics. I was the doctor who got the first medical cannabis licence in the country, for Alfie Dingley – a Schedule 1 licence with the Home Office. Alfie went 48 times to the ICU – at £3,000 a night – and since getting medical cannabis he hasn’t been once. Cannabis would save on opioid deaths, allow people to get back to work, and need less care. By such means I know we can deliver cannabis to NHS at net cost or even a profit – and for all these reasons I very much hope that by the end of 2022 we have NHS prescriptions of medical cannabis.”