Despite the legalisation of medical cannabis back in 2018, access for patients with a multitude of conditions has remained extremely limited in the UK. A lack of acceptable, high-quality evidence is often cited as the reason for this.
In order to address this issue, DrugScience launched their large scale study – Project TWENTY21 – with an aim of recruiting 20,000 patients with a variety of conditions that can potentially be helped with medical cannabis treatment. We spoke to Dr Anne Katrin Schlag and Mags Houston to learn more about the aims of the study…
When and why was Project Twenty21 launched in the first place?
Dr Anne Katrin Schlag: It was launched as a response to the lack of access to medical cannabis here in the UK. As you will know, medical cannabis was legalised in November 2018, which gave hope for a lot of patients and medical cannabis users. They thought they’d be able to use it as a medicine but, unfortunately, it didn’t really materialise here.
So, after a year of fights, we tried to develop a process to prescribe medical cannabis in the UK, and Drug Science decided to set up Project TWENTY21 (T21), launched last year- to improve patient access in the UK, and to contribute to the scientific evidence on medical cannabis.
Right in the beginning, we need to mention that it is not a randomised clinical trial (RCT). Why did you choose to run a different sort of trial at T21? How successful is it already?
AKS: T21 is not an RCT – it is a large-scale observational study. We’re dealing with patient-reported outcomes, addressing a broad range of conditions, which can potentially be treated with medical cannabis.
RCTs are more suited when focusing on a single isolated product, rather than a full spectrum cannabis product for example – it would be almost impossible to do the RCT on all the different compounds and ratios in medical cannabis.
Also, most patients, who are registered with us, have more than one condition, i.e. various comorbidities. These patients often would have been excluded from an RCT due to their complexities.
So far, there are some very promising results. We’re still waiting for more long-term results and data, and we hope those will follow the same trajectory.
The original goal was to enrol 20,000 patients by the end of 2021 – but then the coronavirus pandemic hit. Has this impacted that target?
Mags Houston: That was a very ambitious task, which was originally set pre-pandemic time. There have been a lot of challenges and obstacles along the way, but I’d say that the ambition of 20,000 patients is still there.
This is a very new industry, and we learn as we go. We’re around a thousand patients at the moment, and we’re working with patient support groups to ensure any feedback we get, we are using it to make improvements.
Have you got any feedback from the patients yet?
MH: We’ve got loads of patient feedback saying how much medical cannabis has transformed their lives.
So, the benefit for the project is two-fold. First of all, we help them to get access to reduced priced medication. What we do is to work closely with licenced producers, and they provide us with the funding to run the project in exchange for providing data around their products. It’s really a win-win scenario. We acknowledge that the price – £150 – is still a lot of money for a lot of people. That’s why ultimately the goal is to open up access through the NHS so that people don’t have to pay hundreds of pounds each month.
The second really important benefit is that your data is being used to change policy, and it is feeding into all the research we’re doing. We know that the patients are really keen to be able to give us that data and take part in something truly ground-breaking.
AKS: We published our first paper in April that showed promising findings already, namely that medical cannabis did have a positive impact on the patients’ quality of life.
How much data do you need to start lobbying and eventually get adequate access for those in need of the treatment?
AKS: That’s a very good question. We don’t know for sure, but maybe you should ask the Health Secretary (The interview took place before Matt Hancock’s resignation). There are other international organisations as well who are providing data about the impact medical cannabis has on patients and which could be used as evidence.
MH: We often get asked ‘When will Project Twenty21 be finished?’ or ‘How much is enough data?’ As long as we have funding, we will keep going until we can open up access through the NHS – that is the ultimate goal. As Anne said, we need the Health Secretary to listen and look at the data because it speaks for itself.
We report on dozens of research reports, surveys, studies every month from the US where they claim that medical cannabis is working. Why do you think the UK is lagging behind?
AKS: Politics, regulations, the focus on RCT evidence and British exceptionalism- the perception that research needs to be conducted here to really count…
MH: Medical cannabis is still very much stigmatised in the UK, and it seems as though it is a very difficult narrative to undo here. It is a huge challenge as, just like Anne said, there is this narrative about how we need to provide our own evidence, and that is what we’re doing here with T21! We know that we need UK-based evidence to convince UK politicians that the policy needs to be reformed.
According to your website, with Project Twenty21 you’re targeting patients with some of the most severe conditions – Chronic Pain, Multiple Sclerosis, Post-Traumatic Stress Disorder, Substance Use Disorder, Tourette’s Syndrome, Adult Epilepsy. Would you be expanding the list in the future?
MH: To answer your question, yes, we do want to look to expand going forward!
Something we want to make clearer for people is that anxiety covers so many different things. You can have anxiety, for example, as a result of your cancer diagnosis. Also, you could be experiencing chronic pain from Crohn’s Disease or Endometriosis. So, I want to make it clear that people who are suffering from other conditions, and perhaps are having symptoms of chronic pain or anxiety, are still eligible for T21.
If you look at the website, you might realise that we don’t have Paediatric Epilepsy on the list. At the moment, we don’t have the paediatric neurologist to actually prescribe medical cannabis for the condition. We would love to be able to include childhood epilepsy, but first, we need the doctors to come forward.