Patients on Project Twenty21 report improvements in quality-of-life measures, and ability to manage anxiety, insomnia and depression with medicinal cannabis prescriptions. Bod Australia – one of the producers involved in the study – delves into what this means for medical cannabis.
The first findings from the UK’s largest ever medical cannabis patient study, Project Twenty21, have been published in the esteemed journal Psychopharmacology.
These findings show that legally prescribed cannabis provides clinically significant improvements in the quality of life of patients living with conditions such as chronic pain, multiple sclerosis, Tourette’s syndrome, epilepsy, and Post Traumatic Stress Disorder (PTSD).
How does Project Twenty21 work?
Project Twenty21 is an observational study, established in 2019 by Drug Science, to provide a framework that pairs patients with specialist clinicians that are experienced with prescribing medicinal cannabis. The study gathers important patient data on the safety and tolerability of medicinal cannabis, while simultaneously improving patient access.
To support and fund the study, five licensed medical cannabis producers including Bod Australia, have adapted the costs of their medicines to allow more people to afford them and therefore access medical cannabis.
“We want to give people who suffer from chronic and severe conditions that haven’t had luck with conventional treatment options the chance to try something that could really alleviate their suffering,” said Jo Patterson, CEO of Bod.
Prospective participants were evaluated by trained clinicians and if deemed eligible, were prescribed medicinal cannabis. Patients enrolled in this study had at least two ‘failed treatments’ on their medical records, where commonly prescribed medications, such as opioids, had little to no effect on their ability to manage their conditions.
Participants’ health and progress on the medicines was assessed periodically using a standardised and validated questionnaire of health-related quality of life. This method is also used to study patients with other conditions, such as cancer, cardiovascular disease and dementia.
Findings from the study:
This is the first published Real World Data to be collected on medical cannabis in the UK. The major findings from the interim analysis of 678 participants show:
- Most patients in the study were prescribed medicinal cannabis for chronic pain, then anxiety, PTSD, multiple sclerosis, substance use disorder, Tourette’s syndrome and epilepsy.
- Using medicinal cannabis led to a fifty percent increase in patients’ self-reported health and ability to lead a more normal life.
- Significant improvements in patients’ ability to manage debilitating secondary conditions such as anxiety, insomnia and depression were also reported.
- Patients are now able to avoid criminality with legal prescriptions, as many have felt compelled to turn to illegal use in an attempt to manage their pain/ life-limiting conditions.
- Medicinal cannabis prescriptions provide an opportunity to reduce and stop reliance on widely available medicines, like opioids, that can come with serious side effects, including dependency.
“These results show that for some people with severe and debilitating conditions and who substantially poorer health, treatment with prescribed medicinal cannabis is providing relief and improving their health-related quality of life,” said Dr Adele Hosseini, chief scientific officer at Bod Australia.
“Patient access to medicinal cannabis remains an issue in both the UK and Australia. As doctors and regulatory bodies are calling for more evidence, collecting real-world data from patients using medicinal cannabis in Australia and the UK will help build the evidence base required to support doctors and improve patient access,” Dr Hosseini added.
Despite medicinal cannabis being legalized in the UK in 2018, access for patients remains a challenge due to numerous conditions, including prohibitive cost and doctor support.
Professor David Nutt, founder of Drug Science commented: “A lack of clinical evidence has made it difficult for doctors to confidently prescribe legal medical cannabis in the UK. These new findings provide a major step forward, and help to clarify the benefit these medicines can have for thousands of seriously ill patients.”
Why Real-World Data?
Due to the challenges of studying medical cannabis through rigorous randomised controlled trials (RCTs), Project Twenty21 was set up to develop evidence using real-world data to assess the effectiveness and efficacy of medical cannabis.
Dr Hosseini explained: “While RCTs are still necessary, real world data helps support and guide research efforts by casting a wide net and catching data that might be missed by RCTs.”
About Project Twenty21
Project Twenty21 aims to create a structured body of evidence for the effectiveness and tolerability of medical cannabis for a broad range of conditions, while simultaneously allowing eligible patients to access affordable medical cannabis treatment. This project will provide evidence for NHS funding where the benefits of treatment with medicinal cannabis is proven to outweigh the potential risks
About Bod Australia
Bod Australia is a cannabis-centric healthcare company, specialising in the development and manufacture of medicinal cannabis, CBD and hemp products for a range of therapeutic needs. Bod provides pharmaceutical-grade CBD-dominant medicinal cannabis, produced under Good Manufacturing Practice (GMP), that are being repeatedly prescribed in Australia and the United Kingdom. Bod also provide a range of non-prescription CBD and hemp seed health and skincare products for general health and well-being in Australia, UK, USA, Netherlands and Italy. More information on the clinical research being conducted by Bod Australia can be found here: https://bodpharmaceuticals.com/clinical-research/
Disclaimer: Bod Australia has no control over which products are entered into the Project Twenty 21 formulary or are prescribed by its clinicians. Neither does Bod Australia have any influence over the study’s outcomes.
“I could be a better father with cannabis as my medicine”
Dad-to-be can only afford to fund his prescription for two more months.
Dad-to-be, Leigh Hardwick believes his medical cannabis prescription will allow him to be a better father when the time comes, but unable to work to sustain the crippling costs, he faces a future reliant on opioids.
Fifteen years ago, Leigh Hardwick, was the victim of a violent attack.
In the early hours of the morning at the front door of his flat, he was hit on the head 20 to 30 times with a brick at the hands of a stranger.
At the hospital he was cleaned up and X-Rayed, but was never given a brain scan or offered any psychological support. He was sent home a few hours later with four stitches and a prescription for a packet of painkillers.
No one was ever changed with the attack, but the incident changed the course of Leigh’s life.
He experienced horrendous night terrors and turned to drink and drugs to self-medicate for symptoms which he now knows to be a result of PTSD.
The “impulsive behaviour” and a “lack of self control” he describes at the time, led to him getting in trouble with the police and serving two years in prison for drug-related offences.
“The mental health issues all started at the attack. The anxiety, depression, PTSD, addiction and recreational drug use was accelerated massively by my self-medicating to cope with the PTSD symptoms that I didn’t understand at the time,” says Leigh, now 36.
After experiencing pain since birth, Leigh had been diagnosed with idiopathic scoliosis at the age of 23. He used his time in prison to focus on his health, exercising and attending counselling where he was then diagnosed with PTSD.
But after injuring his back through training he was prescribed codeine, which he pinpoints as the beginning of his problem with pharmaceuticals.
“Upon release I worked hard but I had struggled mentally to adjust,” he recalls.
“After losing some very close relatives I had trouble sleeping again and started to abuse sleeping tablets and benzodiazepines for anxiety.
“My work was being affected and I had a six month absence due to panic attacks and stress, including suicidal thoughts. I was put onto anti-depressants, but nothing improved.”
Leigh sought help through his GP, but despite his scoliosis, doctors decided to detox him from all of his pain medication.
“Because of the addiction and part-substance dependence on the diazepam, it was treated as though every substance I was using I was addicted to unnecessarily. When actually, some of them were needed,” he says.
Leigh was prescribed the opioid substitute, Buprenorphine, leaving him with no pain relief.
“It was horrendous, I was in agony, but received no counselling or support and was continually disbelieved about the pain I was in,” he says.
“I was treated like an addict when really I needed a pain clinic.
“It’s very difficult once you are involved in a drug detox service you’re then tarred with that brush.”
Due to his pain, Leigh was unable to work and over the next few years his mental and physical health deteriorated.
After two years trying to get a referral he detoxed himself from Buprenorphine and a few months later re-presented to the doctor, clean but suffering debilitating pain.
He was referred to rheumatology for tests and a neurophysiological scan and his pain was treated with a cocktail of drugs including, dihydracodeine, gabbapentin and diazepam.
“I was back in front of him in agony, needing scans and painkillers, and so I started back on the carousel,” says Leigh.
“All together, I was prescribed 22 tablets per day at one time and I stuck to my prescriptions but I felt like a zombie. My symptoms were barely under control and I was unable to attend work most of the time.
“Over the four years I was taking these medications I lost touch with myself.
“The combination left me ‘existing’ but with no quality of life. I’d decided the world was better off without me and had zero interest in living.”
Then last year, Leigh’s wife and partner of 11 years, shocked him with the news that she was expecting their first child.
He aimed to get completely clean, using Rick Simpson Oil and THC flower illicitly to cope with the withdrawal symptoms, while he reduced his other medication.
“Cannabis helps with pain, but also with sleep, the muscle twitching and the IBS symptoms. It definitely helped me through the process,” he admits.
“I had no idea medical cannabis was legal at that point, until someone mentioned Project Twenty21 in a group chat, but I put off looking into it for fear of disappointment.”
In January of this year, Leigh had his first consultation with a leading pain specialist at The Medical Cannabis Clinics.
“In my initial consultation I was understood, I was listened to and treated like an adult. It was a really refreshing experience,” he says.
“It is not a cure. I’m not jumping around, by any means. I do still suffer pain most days and struggle with mobility, but it’s more about the lack of side effects from the other drugs that I was taking.”
But unable to work and relying on disability benefits, funding the monthly £680 private prescription long-term, is unsustainable for Leigh, even with the support of Project Twenty21.
His wife currently supports him with her income, but he only has enough savings for around two more months and has already had to go back on some of his prescription drugs to help reduce the costs.
Leigh also has to fund private mental health support and counselling, as he is no longer able to access NHS services due to his previous drug use.
“It’s just a matter of time until we’re unable to afford it anymore,” he says.
“If money wasn’t an issue and I could access as much cannabis as I need for my conditions, I believe I could probably function as a normal human being in society, albeit with pain issues.
“I could probably go back to work, if it was a part time job where I sitting down.”
He fears that if he has to go back to relying solely on opioids and depressants, he won’t be able to be the father he hopes to be to his soon-to-be-born daughter.
“My main focus and priority now is being the best father that I can be,” says Leigh.
“The best way that I can do that is with cannabis as my medicine. It’s definitely the way I am most in charge of my thoughts and the most competent.
“Previously, I was totally disinterested in life. I had a consistent mantra in my mind, that was, if anything goes wrong, at least I can kill myself. I was on the verge of that for years, but that option is gone now, because I’ve got a child and that’s also not what I want for myself or for my family.”
He adds: “The worry is, if I reduce the cannabis and take on other medications I may become disconnected again and that will emotionally close me off.”
During lockdown this year, Leigh connected with other medical cannabis patients and helped set up an online support group.
Along with his co-founders, Sylv, Ryan Holmwood and Dominic Stenning, he guides others through the process of approaching healthcare professionals and accessing a prescription, as well as campaigning for ‘fair access’ to cannabis-based medicines on the NHS and to change societal and cultural views.
But supporting other patients has had benefits for Leigh too, giving him something positive to focus on.
“I’ve contributed to negativity to society and I suppose this is my way of trying to make reparations for that, to try and swing the karma balance back a bit,” he adds.
“I’m really thankful to everyone we’ve supported, for their feedback and ongoing help that’s given me so much over the last four months.
“I don’t think there’s anything better you could do, than to help disabled people live a better life.”
Jane West – The mum who was fired for using cannabis built her own empire
The entrepreneur and founder of Women Grow is determined to change the narrative around cannabis
Made famous by her high-end cannabis-friendly events, Jane West was fired from her corporate job for consuming on TV. Now at the helm of her own cannabis empire, she is determined to change the industry narrative.
Jane West’s ideal Friday night is putting on a cocktail dress, going to a fancy restaurant or event and “getting high”.
“I’m an avid cannabis consumer,” she tells me from her home in Colorado, where cannabis has been legal for recreational use since 2012.
“I see it as part of a wellness routine.
“If I’m going to get a babysitter and go out on a Friday night and spend $100 at an event, I want to get dressed up and be fancy and also be high.”
In 2014, alongside her corporate job, West launched her own cannabis-friendly events, where adults could get together to consume socially.
The events took place in private art galleries, with live music and even hosted a fundraiser for the Colorado Symphony Orchestra held at the famed Red Rocks amphitheatre with 5,000 guests.
They also attracted international media coverage. A reporter from the UK Telegraph attended the first one, with the Daily Mail later describing them as ‘sophisticated cannabis soirees’ with ‘foodies for munchies’.
At her second event, a clip of West unashamedly telling the camera; ‘I’m a mum and I use marijuana, and that’s okay’ was so newsworthy it made the five o’clock evening news.
West was fired from her job when her bosses saw the clip.
“I’ve never been fired from everything in my life and I have had a job since I turned 15, so to have a career where you have a salary end like that was dramatic,” she recalls.
“I definitely did not intend that to happen, at the time was that people thought I was trying to get fired.
“The fact that the woman hosting the weed events got fired from her job became a whole new story.”
Even though cannabis is legal and easily accessible for many in Colorado, residents are not permitted to consume it publicly.
As West puts it: “Even though everyone has access to it, there’s very few places where you can go to consume it.”
Eventually one of West’s events was raided by police and she received criminal charges.
“They had me on probation and made it clear that if I did anything else they would put me straight in jail, so I had to figure out what I was going to do,” she says.
“My event company wasn’t going to work until we passed social legalisation.”
Even now, six years on there is little sign of this, with several bills which would permit social consumption businesses failing to get through in recent years.
West is hopeful though, that the need to restart the economy and hospitality sectors following the coronavirus pandemic may spur things on.
“Social use is going to be the last domino,” she says.
“I hope that this might come from the pandemic, in the next year or two as these, as we start to get back to normalcy and we have all these empty storefronts and restaurants and hotels.”
West adds: “One of the biggest issues, is that we don’t see people consuming cannabis like you see people drinking alcohol.
“A significant element of cannabis culture is those scenes of a dude sitting on a couch with a bong at his crotch, but that doesn’t reflect my cannabis experience. I want images of a woman, dressed up with a joint in a high-end setting, then people will start to think differently.
“With social use, that’s when people will actually be able to see people using cannabis and realise that it’s for everyone.”
Edible Events was over – at least for the time being – but West’s cannabis career was just starting to take seed.
“Women from all over the world were reaching out to me and asking how to get into the cannabis industry,” she says.
“I was like, ‘I don’t have a job anymore, I don’t grow weed and the events that I planned are completely illegal, I am not the person you should be asking’ – but no one else was paying attention to women.
“All of the legalisation groups and companies launching were led by men – mainly generationally wealthy white men, who had the money to get started.”
Under her new alias – Jane West – she founded the networking organisation Women Grow, to connect women with others in the industry and with the premise to create more female-owned cannabis companies.
“I realised that women need to change the way they think about cannabis, or uneducated stereotypes about it would to prevent them from entering the industry at exactly the time they should,” she says.
Over a quarter million people have attended Women Grow’s networking events and national conferences in Colorado since its inception, with members launching their own branches in 40 cities across the US.
By 2016, West was ready to dabble in cannabis entrepreneurialism herself, and having recruited the next generation of Women Grow leaders, she divested the vast majority of her interest in the company and it is now majority black female-owned, she tells me.
After testing the water with a limited edition range of glassware and smoking paraphernalia, West went on to raise $1.3 million in seed funding from 22 accredited investors, 80 percent of which is held by women and people of colour.
She spent the money developing her signature travel collection – a range of sleek, stylish and discreet vaporisers and pipes and now partners with minority and family-owned businesses across the US to supply Jane West-branded CBD products and whole-plant cannabis, which comes in two simple formulations; day and night.
“Cannabis is confusing and intimidating, which is unfortunate because it is a safer alternative to prescription medications and alcohol, which are the primary substances that people are consuming. We want to take that confusion away.” West explains.
“Our customers know that I vet and find great growers, so it makes them more confident and it simplifies the buying process.”
In 2020, the number of cannabis retailers carrying the Jane West brand tripled from the previous year and it has now secured licensed cannabis partners in 13 US states, and Canada.
West doubled her revenues last year and recently closed another round of seed funding, with thousands of investors from 42 countries.
But despite its success on paper, she insists the company is still in “start-up mode” – and that she really “didn’t know what she was doing”.
“I did my best to leverage the fact that my name was out there, but I definitely wasn’t trying to front anything,” she says.
“I was like ‘I think we should have this networking group, and I don’t know what I’m doing but I think we should make bongs.’
“The more candid you are about what you don’t know, the more transparent conversations end up being and the further you get. I think that’s important in cannabis now more than ever, we need more transparency.”
This might not have been the plan, but having built her own cannabis empire – and a space which empowers women to do the same – I can’t imagine West would change anything now?
“I don’t have any regrets… I helped women make the critical connections they needed to manage an extremely hostile unwelcoming business environment, but I wish I could point to more female-owned businesses and say that’s because of Women Grow,” she admits.
“In Illinois only 21 licenses to grow have been issued, in Colorado there’s 2,500. In most of the states in the US, women and minorities were not granted licences – why that occurred is up for question.”
West adds: “I wish I’d spoken up earlier about the inequality.
“The most important reason to keep talking about being a woman or a minority is to keep pointing out that you’re the only person in the room. This [industry] just started, it shouldn’t be so inequitable already.”
“It was like a miracle” – MS sufferer who supplied hundreds of patients with medical cannabis
Diagnosed with MS aged 21, Lezley Gibson supplied medical cannabis to patients across the country.
Over the past 25 years, Lezley and Mark Gibson have supplied £500,000 worth of cannabis-infused chocolate free of charge to MS patients across the country. Having faced prosecution five times, they are now both benefitting from a legal medical cannabis prescription.
In 1985, at the age of 21, Lezley Gibson was diagnosed with multiple sclerosis.
Her doctors told her that within five years she would be incontinent and in a wheelchair. Thirty six years later, Lezley is neither – and she believes she has cannabis to thank.
“Everything that I’d ever seen about MS was very gloomy”, Lezley said.
“I was destroyed when I was told about the diagnosis.”
At the time, Lezley was in the midst of starting a business, having just opened her own hair salon.
“I had big plans for myself, but then halfway through opening my own salon, I was diagnosed with MS and that was my career over. It’s very difficult to cut hair when you’re shaky and you can’t walk properly,” she said.
“It was a very hard time for me; I found it very difficult. I was your typical 21-year-old. I was into clothes and makeup, I was a hairdresser and I loved people and dancing. But that was the end of that.”
A year after her diagnosis, Lezley met her now-husband, Mark. As a recreational user at the time, Mark introduced Lezley to cannabis and she said the effect it had on her condition was “miraculous”.
“I had never really come across cannabis before, but I noticed when I was with Mark and his friends that I felt an awful lot better, not just because of the relationship but because I was consuming cannabis,” Lezley recalled.
Prior to taking cannabis, Lezley’s body felt tense and was prone to spasms.
“I never felt very comfortable,” she said.
“My body never really worked properly. But I noticed with the cannabis in my system, my body was calmer, my spasms disappeared and all the other little things faded into insignificance.”
The pain and nausea that she experienced on a daily basis began to fade as well. Meanwhile, her eyesight and speech, which she had begun to lose over the past few years, improved.
At the time, in the mid-1980s there was very little information about cannabis as a therapeutic drug, but Lezley was finding that consuming the plant was having a much more positive effect on her condition than the medications prescribed by her doctors.
“I’m not a fan of drugs of any description… they’re far too strong,” Lezley said.
“They put me on steroids, which made me double in weight and grow a beard, which was fantastic at 21. After that, it absolutely terrified me.
“With everything they offered me, they said ‘it might make you worse’, which wasn’t very appealing. But with cannabis, there weren’t any of the side effects. It was nothing like what the doctors were offering me.”
She added: “The only side effect I found with cannabis was it made me feel quite nice and there are not many things that do. I have MS so I don’t get to feel nice very often.”
As Lezley continued to benefit from taking cannabis, she decided not to keep it to herself. She wanted to make other people with MS aware of its benefits and how it had improved her condition.
In 1995, she was a guest on the popular BBC One chat show, Kilroy. On the show, she met other people like her, including Claire Hodges, an influential activist who campaigned for the therapeutic benefits of cannabis and later played an important role in GW Pharmaceuticals earning its licence to produce Sativex.
Lezley became good friends with Hodges and soon found herself in a circle of fellow MS-sufferers campaigning for the benefits of cannabis. One of these campaigners was Elizabeth Ivol, who was producing cannabis-infused chocolate from her home in Orkney.
Unfortunately, Ivol was raided by the police and soon lost the ability to continue producing the chocolate as her condition worsened. She asked Lezley and her husband, Mark to take over the operation.
The couple found themselves making cannabis chocolate for hundreds of people with MS. The very real possibility of them being raided by the police rarely left their mind, but they were determined to continue helping patients.
“There was success with the people who used our chocolate and this is why we kept going,” Lezley said.
“In one instance a lady from a nearby village wrote me a letter. She’d been bedridden for four years so her husband came knocking on my door to get some chocolate. Within a week of her using the chocolate, she was taking her grandchildren to the park and sewing curtains. It was like a miracle.”
Over a two year period, Mark and Lezley supplied 33,000 bars of THC chocolate, free of charge to MS patients across the country.
But such a large operation was difficult to conceal from the local police and the couple were raided three times between 1995 and 2003.
“I have a daughter and my poor daughter has witnessed all of this since it began,” Lezley said.
“It was a difficult time. When I did the school run you had all the women standing in little groups and it was definitely them and me. A lot of people thought I was just a ‘druggie’ which I can assure you I am not.
She added: “Even members of my own family had an opinion, but I had to do what I had to do – I had to be well and that was how I was well. If people didn’t believe me then that was their fault, not mine.”
In 2003, a police raid resulted in them being charged with conspiracy to supply £500,000 worth of the illicit chocolate.
It wasn’t their first run-in with the law. In 1999, Lezley had been charged with possession for carrying a small amount of cannabis flower. She successfully pleaded not guilty, arguing that using cannabis prevented an MS attack, with the jury accepting her argument.
This time, they weren’t so lucky.
The judge agreed that what they were running was an ‘altruistic enterprise’ with little to no money made during their time supplying cannabis to MS patients.
But unfortunately, the jury found them guilty and the couple along with a collaborator, Marcus Davies, were sentenced to 18 months in prison which was then suspended for two years due to Lezley’s condition and Mark’s responsibility as her primary carer.
Lezley and Mark kept their heads down for the next 15 years, but after the police were informed of the couple’s cannabis consumption, their home was raided once more in 2019.
The police only found three bars of cannabis chocolate for Lezley’s own personal use, but a discovery of Mark’s modest-sized grow room set off another court case.
In between being charged and appearing in court, Lezley became one of the first patients in the UK to receive a medical cannabis prescription, which Mark believes prompted the Crown Prosecution Service (CPS) to rethink their position.
Although Lezley and Mark both freely admitted possession and production of cannabis, the CPS decided not to offer any evidence and the couple were found not guilty in January 2020, a year after being arrested.
“To be found not guilty when you’re not denying any of the facts and you clearly are guilty in the eyes of the law, that’s a real seismic shift,” Mark added.
“We were both prepared to go to court, run it to the jury and stick to our principles and our staunch refusal to plead guilty. However tiring it is, sometimes you just have to stick to your guns and say you’re not going to bend.
“We did absolutely nothing wrong but treat our illnesses with an herbal remedy.”
Mark and Lezley both have a legal medical prescription now and although they believe things are headed in the right direction, they remain critical of a system that shuts many people out.
Mark continued: “What we’ve got now is what I would call economic legislation. Those who can afford it can have it, and those that can’t afford it can’t have it and that’s wrong.
“How is it fair to prosecute somebody around the corner who is medicating for an ailment and bought the cannabis illegally because they can’t afford the consultancy fee and prescription?”
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