Europe’s largest medicinal cannabis registry, Project Twenty21, is beginning to gather pace. Steve Jones spoke to Drug Science chief executive David Badcock ahead of the publication of its first data set.

In late February, the first data from what has been touted as Europe’s largest medicinal cannabis recruitment registry, Project Twenty21, is expected to be released.

The analysis will be published in the Journal of Psychopharmacology, and contain analysis from around 250 patients. The initial findings, while still under wraps, have been described as “interesting”.

Drug Science CEO David Badcock: ‘The data will be a great starting point.’

For UK-based Project Twenty21, or T21 as it is known, the publication will mark the first steps on a road to further the understanding of medicinal cannabis, and to demonstrate its efficacy and safety.

Through continuous gathering of real-world evidence, project leaders want to build a compelling case for medicinal cannabis to be more widely prescribed by GPs and, ultimately, to be available on Britain’s National Health Service.

“The data is going to be a great starting point,” said David Badcock, chief executive of Drug Science, the organisation behind T21.

“It’s the first data set that we have and it shows some interesting things. We’re really excited.”

The intention is to develop and publish rolling data “every few months”.

“As we progress, we’ll have follow-up data that hopefully will show improvements in patient outcomes,” he said.

The beginnings

Drug Science is an independent, science-led charity formed in 2010 by David Nutt, a respected Professor of Neuropsychopharmacology.

The idea for a registry of cannabis patients emerged in 2018 during a day-long conference where the paucity of evidence surrounding medical cannabis became a talking point.

It wasn’t until late 2019 that Project Twenty21 was formally launched, with Drug Science setting out ambitious goals to enrol 20,000 patients by the end of 2021.

Clinic networks were invited to participate, with a view to generating rolling data that, over time, could be presented to regulatory authorities to help shape future policy.

The registry aims to target and pull together data on six indications; anxiety disorder, chronic pain, MS, Post-Traumatic Stress Disorder, Substance Use Disorder (as a harm-reduction strategy) and Tourette’s syndrome. Patients wishing to be part of the study must have been prescribed two medications that have failed to work.

“We wanted a collaboration of industry partners to work together to help overcome the barriers for prescribing,” Badcock said. “We wanted to address the fact that there isn’t enough evidence in the UK, certainly not enough for our regulatory authorities.”

While acknowledging regulators, and the wider medical profession, have traditionally looked towards randomised controlled trials (RCTs) to guide and inform decision making, Badcock suggested they are becoming more open to the “reliable and robust” data that can be extracted from real-world observational studies.

“To be honest, RCTs are not going to happen. If we sit around and wait for them, nothing is going to happen. We’ll be waiting for years and years and years.”

Drug science ceo david badcock

The UKs TGA equivalent, the Medicines and Healthcare products Regulatory Agency (MHRA), has indicated as much, he said, while the Advisory Council on the Misuse of Drugs, another government agency, went even further in a recent report by concluding patient registries will be instrumental in determining the evidence base for effectiveness and safety.

Furthermore, randomised controlled trials for cannabis are simply unrealistic, Badcock said.

“To be honest, RCTs are not going to happen,” he said. “It’s just not possible to try and deliver RCTs with cannabis and the range of conditions it can treat, so observational data is the only way you can do it.

“RCTs are also very costly, timely and actually quite a narrow way to look at things. If we sit around and wait for them, nothing is going to happen. We’d be waiting years and years and years, and it would probably never happen.”

GP attitudes

Unlike Australian doctors – though not all given Tasmania’s primitive approach towards medicinal cannabis – GPs in the UK can only prescribe the medication under the supervision of specialist consultants.

But there are signs that attitudes are shifting, Badcock suggested, just as they are in Australia, with growing interest in the potential of medicinal cannabis.

Yet it’s clear the interest is still patient-driven, with consumers often better informed than their GP.

The problems in Britain mirror those in Australia, and elsewhere, with a lack of doctor training, enduring stigma and limited awareness responsible for “undoubted barriers”.

“A lot of doctors may have heard snippets of information, but they just don’t know enough about it and, quite understandably don’t have the confidence to even have a discussion with a patient who probably knows a lot more about it than they do,” Badcock said. “It is challenging for doctors and at Drug Science we are trying to change that with educational courses and engaging more with GPs.

“I think the tide is turning, and that’s certainly one of the aims of the project, to get more doctors to prescribe.”

Growing pains

If the education of GPs is still in its infancy, so too is Project Twenty21 itself.

Of the 20,000 patients it originally hoped to register by the end of this year, it so far has less than 700.

Not that Badcock is overly troubled at being so far behind initial targets.   

“It remains to be seen how many patients we’ll have by the end of the year, but if we get even a quarter of that 20,000, we’ll have some really powerful data at that point,” he said. “But we’re already happy with the data we are getting, and it will continue to grow.

“We’ve actually not really talked about the 20,000 figure. That’s very much an aspirational stretch target that we think we’ll get. We do have a timeframe in mind (for the 20,000) but we’re not saying publicly what that is. It’s not great to set a target you are beholden to, and we’ve learned from that. But we are hoping to see exponential growth. That’s certainly the idea.”

Among the fundamental challenges for T21 has been the generally low number of prescriptions being written for medicinal cannabis in the UK, while supply has also been somewhat erratic, Badcock said, a situation not helped by the onset of Covid at the start of 2020.

The pandemic prevented any progress being made in discussions with health authorities over importation regulations, something that posed a “real challenge”, Badcock said.

Nevertheless, he said project leaders were happy with the variety of licensed producers and cannabis products on its formulary.

Among the official suppliers are Bod Australia, UK firms Cellen Therapeutics and Lyphe Group and Khiron Life Sciences, T21’s Latin American supplier.

A fifth supplier, Toronto-based Jamaican Medical Cannabis Corporation, is due to start providing product in 2021.

Cann Group and Cannatrek said they too are supplying products for the observational study via their UK supply arrangements with Lyphe.

Badcock stressed that T21’s participating cannabis clinics – Sapphire Medical Clinics, Medical Cannabis Clinics and One Orthopaedics Pain Management – are under no obligation to prescribe medicines on its list.

“We clearly can’t force doctors to prescribe anything, it is always a clinical decision based on a clinical assessment,” he said. “Our formulary is pretty comprehensive and the majority of patients who want to be part of T21 are prescribed off the formulary. But our role is purely to observe what’s happening.”

While Drug Science instructs participating producers, such as Bod, to cap the cost of medicine at £150 (A$267) a month, it is arguably still out of reach for many patients, a fact acknowledged by Badcock.

Yet it would be unrealistic for suppliers not to cover their costs “at the very least”.

“One of the biggest barriers to medicinal cannabis is cost, and there’s no doubt some patients can’t afford £150,” he conceded. “And let’s not forget, that’s just the medication. There’s also the cost of the private consultation. But it’s just not possible to do something like this free of charge for patients. It’s an observational study, not a trial.

“But the interesting thing, and it’s something we’re proud of, is that when we started the project, the costs were really quite high, both in terms of medication and consultation fees that were in the region of £200 and £300. Since we launched, costs have come right down across the industry and I believe that’s a direct impact of T21 and the competition it has created.”

Appointments are now as little as £70, he said, even at clinics that are not part of the study.

Efforts to enrol more clinicians in Project Twenty21 are underway as it looks to expand the study and inch towards its 20,000 target.

While largely designed to convince UK regulators and prescribers of the merits of medicinal cannabis, global markets, Australia included, are keenly following the study.

“Our two big outcomes are GPs prescribing medicinal cannabis and the NHS paying for the treatment, so it’s free at the point of care, just like other medications,” Badcock said. “That’s the ultimate aim.”

For Badcock, and the Project Twenty21 team, publication of its first data set in February represents the first step in achieving those aims.

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