Thousands of patients are using medical cannabis for conditions where there is ‘debatable’ clinical evidence – a new paper highlights why regulators must take real-world data into account.
A new study highlights the potential of cannabis to treat a broad range of conditions from chronic pain and intractable epilepsy, to mental illnesses such as anxiety, depression and schizophrenia.
But despite thousands of patients using cannabis for these conditions, the data around many of them remains “controversial”.
Researchers are now calling for Real-World Evidence (RWE) databases to be developed in order to “bridge current evidence gaps” for the use of medical cannabis.
A team from Drug Science, the UK-based charity behind the paper, has published an in-depth summary of the latest developments in cannabis research, taking in account findings from global registry databases, major reviews and patient-reported outcomes.
It concludes that conditions which see the highest numbers of patients turning to medical cannabis, often have ‘debatable’ clinical evidence but good RWE.
Prescription registries reveal large numbers of patients are using cannabis to treat their arthritis, sleep disturbances, depression and anxiety, despite the limited RCT evidence.
The strongest, most conclusive data to support the efficacy of cannabis based medicines is in conditions with relatively small patient numbers, such as intractable epilepsy, multiple sclerosis (MS), cancer-related nausea, and appetite stimulation in wasting disorders.
Other, less common conditions, including fibromyalgia, schizophrenia, migraine, glaucoma and Tourette’s syndrome were found to have “limited proof of concept RCT or observational data” to support the use of medical cannabis, which the authors say warrants more research.
Dr Anne Katrin Schlag, head of research at Drug Science tells, Cannabis Health: “When you look at the RCT evidence base for some of these conditions, it is in some ways controversial – it’s not as strong as many scientists and doctors would like it to be.
“But there are thousands upon thousands of patients globally, who have been using medical cannabis successfully to treat these conditions, which is really building a pattern of evidence.
She continues: “There are many conditions, which have quite a low strength of RCT evidence and also have low numbers of patients, but that evidence base is developing, which is very exciting.
“We argue that the evidence base should be widened to include these patient-reported outcomes.”
The nature of cannabis products, which are made up of many different combinations of compounds, makes conducting RCTs – which are widely viewed as the “gold-standard” of medical trials – challenging and time-consuming.
Research also shows that many patients with the conditions which could benefit most from cannabis treatments, also live with a number of co-morbidities, such as anxiety, depression and insomnia, which would make them ineligible for clinical trials.
“RCTs are the gold standard in medicine but in relation to medical cannabis that’s quite a challenge,” Dr Schlag continues.
“To complete RCTs for all the variations of potential cannabis based medicinal products and all the conditions cannabis is potentially useful for would take years, when many patients can benefit from the medicine now.”
Dr Schlag and her co-authors would like to see a systematic network of databases, with international guidelines for collecting RWE on cannabis medicines, which could help build this “pattern of data”.
“It’s really important that we pull these databases together in order to have a systematic collection of data, which could provide more support for medical cannabis,” she adds.
But even where the paper deems there to be a “high strength of data” for treatment with medical cannabis, for instance neuropathic pain, cancer-related pain and chronic pain, access remains limited for UK patients.
The International Association for the Study of Pain does not endorse the general use of cannabinoids to treat pain, due to a “lack of evidence from high quality research” , and the National Institute for Health and Care Excellence (NICE) in the UK does not recommend doctors prescribe cannabis medicines for chronic pain.
A recent multi-criteria decision analysis by Drug Science found that medical cannabis improves patients’ quality of life more than any other treatment for chronic neuropathic pain, when compared to 12 of the most commonly prescribed prescription medications.
The researchers say NICE and other regulators should take these findings into account.
“The evidence based globally has shown again and again that a large number of chronic pain patients are using medical cannabis to treat the condition, this is already out there, it’s already happening,” adds Dr Schlag.
“It’s time to have a discussion of how to incorporate these findings into decision-making.”
Fair Trials and Last Prisoner Project seek to launch global cannabis justice project
Fair Trials’ Global CEO Norman L. Reimer to discuss the project at Cannabis Europa Conference in London on June 29.
A new initiative from Fair Trials and the Last Prisoner Project aims to redress the harm caused by cannabis prohibition and to secure relief for those in prison for cannabis-related convictions.
The criminal justice reform NGO, Fair Trials hopes that the industry will support its work in countries across the globe where cannabis laws are being liberalised. Through collaboration with local partners in appropriate jurisdictions, the Fair Trials project will identify people in need of legal assistance, and recruit, train and match volunteer lawyers to take on their cases.
Fair Trials has enlisted the help of the Last Prisoner Project, a coalition of cannabis industry leaders, executives and artists dedicated to bringing restorative justice to the cannabis sector.
More and more jurisdictions are allowing adults to use and distribute medical and recreational cannabis. But after decades of prohibition, countless people remain behind bars or continue to suffer the collateral consequences of a cannabis conviction.
“The injustice of cannabis prohibition has resulted in millions of people worldwide serving time in prison or being saddled with a cannabis conviction, which brings with it a lifetime of harmful consequences, ranging from education and employment opportunities to immigration status and parental rights,” said Fair Trials Global CEO, Norman L Reimer.
“Of course, these harmful effects of prohibition not only impact the individuals charged, but also their families and communities. And those effects have been borne disproportionately by minorities, communities of colour, and the socio-economically disadvantaged. Legalising cannabis alone does not equal justice. Together, we must address the ongoing harms of past prohibition and leave no cannabis prisoner behind.”
The project will be modelled on the US Cannabis Justice Initiative, a collaborative effort between the cannabis industry and volunteer lawyers in the United States. When Norman Reimer was the Executive Director of the National Association of Criminal Defense Lawyers (NACDL), he partnered with the Last Prisoner Project to establish the initiative.
“Key to the success of the initiative has been generous donations from legal cannabis companies and consumers nationwide,” said Last Prisoner Project Co-Founder Steve DeAngelo. “Fair Trials, with its global reach as the world’s criminal justice watchdog, is uniquely positioned to build and house the infrastructure that’s going to be needed.”
Tomorrow (29 June), Norman Reimer will address the Cannabis Europa Conference discussing the project. Mr Reimer will be part of a panel entitled ‘Leave No Cannabis Prisoner Behind,’ and will be joined on that panel by Mary Bailey, Managing Director at the Last Prisoner Project; Dr. Laura Garius, Policy Lead at Release; and Denzel Uba, an individual impacted by criminal cannabis prohibition.
TOWIE star Amy Childs launches CBD range in honour of Jorja Foundation
The product range sees a portion of the proceeds going to the Jorja Foundation.
TOWIE star Amy Childs launched her new CBD range this week, with a star-studded event that shone a spotlight on the story of six-year-old Jorja Emerson.
Amy Childs was joined by former Love Islanders, Amy Hart and Cara Delahoyde-Massey, alongside her co-stars, Frankie Essex, Tom Skinner, Carina Lepore, Saffron Lempriere and Mark Ferris, for a heart-warming event celebrating the launch of her new CBD Infused beauty range, Jorja Botanicals.
The signature collection sees a portion of the proceeds going to the Jorja Foundation, which was set up in honour of six-year-old medical cannabis patient, Jorja Emerson.
The event saw The Only Way Is Essex star Frankie Essex, break down in tears as she heard Jorja’s story. Frankie, who gave birth to twins four weeks ago, wiped her eyes when Robin Emerson, Jorja’s father, showed videos of the life-threatening seizures his daughter was suffering before they discovered medical cannabis.
Love Island star, Amy Hart has since taken to Instagram to spread the word about the latest political campaign that sees Childs and Emerson petitioning to make medical cannabis more widely available on the NHS.
The Jorja Botanicals range was inspired by Jorja, who was diagnosed with a rare chromosome abnormality called 1q43q44 deletion, which has a side effect of life-threatening seizures. Her illness resulted in her being admitted to intensive care on two separate occasions, where Robin was told that she may not make it.
To save his daughter’s life, Emerson knew that he had to dig deep and find a treatment that would not only help Jorja but ultimately go on to help others.
At the time it was still illegal to prescribe cannabis in the UK. Emerson joined the campaign to see medical cannabis legalised in the UK in November 2018, and Jorja’s was among the first children to be legally prescribed medicinal cannabis.
In 2021 he went on to create the Jorja Foundation – a charity set up to help other families and children going through the same battles that Robin had to face.
The Jorja Foundation’s core principles are to fund special needs equipment that is not funded through the health system, fund family counselling, private appointments and tests when a second opinion is needed, as well s cannabis-based treatment for children in the UK and to continue to campaign and educate for wider NHS access in the UK for cannabis-based medications.
Childs commented: “When I saw Robin & Jorja’s story on social media it broke my heart.
“As a mum, I couldn’t imagine the pain of being told to take my child home to say goodbye to them. I love that Robin has fought for Jorja & is now helping other families with the Jorja Foundation.
“I’m so happy that I can help the foundation by being the Creative Director of Jorja Botanicals. We have created some beautiful products for the whole family to enjoy. We will be donating a percentage of the proceeds to the foundation so that we can help as many families as possible. ”
Emerson added: “ This is the fruition of a lot of hard work over many months and I am extremely proud to launch what is the first family brand in this category. In the coming weeks, we will also be launching a ‘parent’ focused cosmetic range in partnership with our creative director Amy Childs and our premium line of tincture oils.”
South Africa launches first trial of cannabis for chronic pain
The study will test whether cannabis can replace opioids in the management of chronic pain.
South Africa’s first cannabis trial has launched after initial results “show promise” for the treatment as a replacement for opioids.
The study will involve 1,000 participants who have been taking opioids for pain management for at least three months and are prepared to switch to cannabis as an alternative.
Biodata is the brainchild of Dr Shiksha Gallow, a cannabis clinician and the principal investigator in the trial which took over 18 months to get official clearance.
Dr Gallow said the trial is set to be ground-breaking as South Africa’s first real-world study of medical cannabis. Researchers predict that it will provide much-needed insight into the link between cannabis genetics and patient outcomes.
Dr Gallow told Cannabiz Africa: “We are currently recruiting patients, and data-capturing all the questionnaires and feedback from the patients for the live Study. It has been fairly slow. However, more options have been introduced, as suggested by the patients in the pilot study.
“The pilot results of the study were very promising, as it showed 98 per cent of the patients have some sort of pain relief from the cannabis.
“We were able to wean these patients off their opioid treatment. In the pilot group of patients below the age of 55, it was shown this group preferred to smoke cannabis and patients older than 55 years preferred oil. The patients who smoked the cannabis had relief almost immediately, while the oil took some time to alleviate their pain.”
“Once we reach the sample size required and all of the relevant data has been collated, the results of the study will be published. We have currently renewed this study for another year, due to the initial slow uptake of research participants.”
Patients can apply to be research participants through the Biodata website.
Labat is expanding its footprint over the next few months with the introduction of CannAfrica kiosks in major shopping malls.
The company believes these will be the “ideal locations for physical sign-up points for the study”.
Labat said the kiosks will also serve as Biodata dispensaries and is engaging with a number of vape stores to do the same, although these would have to be subject to South African Health Products Regulatory Authority’s pharma-ethics requirements.
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