An early UK trial suggests that cannabis-based drug Sativex, used alongside chemotherapy, could improve life-expectancy in patients with severe brain cancer.
An oral spray containing cannabis-derived chemical extracts is well tolerated and may extend life-expectancy in patients with recurrent glioblastoma, when used in combination with chemotherapy.
In a new phase 1b trial, researchers led by Professor Susan Short at the University of Leeds assessed the safety and potential effectiveness of adding the cannabis-based drug Sativex to temozolomide, for patients with a newly recurrent glioblastoma (GBM).
While the study observed better one-year survival in the group receiving Sativex, the researchers caution that a larger, randomised trial is needed to assess whether adding Sativex to temozolomide could offer additional life-extension.
The study also showed that Sativex did not appear to interfere with temozolomide treatment.
Sativex – also known as nabiximols – is a complex botanical formulation containing cannabinoids THC and CBD, alongside other components.
It is currently licensed and used in treating muscle stiffness and spasms in certain people with multiple sclerosis.
In the first part of the study, six patients received a personalised regime of Sativex of up to 12 sprays per day, alongside their temozolomide therapy – and the side-effects were recorded and reviewed.
The most common side-effects reported were fatigue, headache, vomiting and nausea, which were mostly classed as being mild-moderate in severity.
In the second part of the study, 21 patients randomly received either Sativex with temozolomide (12 patients) or placebo with temozolomide (9 patients) for a total duration of 12 months.
Ten out of 12 (83.3 percent) of the patients receiving Sativex were still alive after one year, compared to four out of nine (44.4 percent) patients who were given a placebo.
However, two patients in the placebo arm died within 40 days of enrolling and the researchers caution that these patients may have been predisposed to a shorter survival due to features of their tumour, which could skew the comparison.
The findings come as The Brain Tumour Charity has launched a grant round with a view to funding a phase II/III multi-centre placebo-controlled clinical trial of cannabinoids in the treatment of high-grade gliomas later this year.
The charity has welcomed the developments and called for urgent further research into the potential of cannabinoids to provide new treatments and “new hope” for patients.
“These are really promising findings and we now urgently need to see a larger clinical trial to understand whether adding cannabinoids to chemotherapy could offer precious extra time to live for people living with a glioblastoma,” commented Sarah Lindsell, CEO at The Brain Tumour Charity.
“With so few options available, thousands affected by a glioblastoma in the UK each year are in urgent need of new treatments, and of new hope.
“It’s fantastic to see that Sativex could be well-tolerated alongside temozolomide, and that this combination is showing promise in potentially improving outcomes.”
Lindsell added: “We know there is significant interest among our community about the potential activity of cannabinoids in helping relieve symptoms and as a treatment, and we need to do all we can to accelerate these answers and to drive progress.
“A cure really can’t wait – and we are really excited to be launching an exceptional grant round to fund a major clinical trial in the UK later this year to fully understand the potential of cannabinoids.”
The study is published in the British Journal of Cancer (BJC).
In an accompanying editorial, leading UK experts argue the findings “warrant urgent exploration of the combination of temozolomide and nabiximols in a sufficiently powered larger study” alongside research to identify any biomarkers that could help predict their effectiveness for individuals.
The BJC editorial, by Dr Gary Doherty at Cambridge University Hospitals NHS Trust and Dr Bruno de Paula at the University of Cambridge, also cautions against the use of off-label nabiximols or other cannabinoid products in patients with GBM until sufficient high-quality evidence supports their use, particularly given the significant side-effect profile.
The Brain Tumour Charity recommends that any supplements, alternative or complementary treatments that patients wish to use are discussed with their medical team.
Anyone affected by a glioblastoma can speak to the charity on 0808 800 0004 or by emailing firstname.lastname@example.org.
“I feel hugely let down by the system”: Patients fall victim to UK’s cannabis supply issues
Medical cannabis patients report being left without medication, as supply issues become a “major concern” for the UK sector.
A surge in demand for cannabis medicines, combined with the increased red-tape facing importers has led to patients experiencing severe delays to their prescriptions and even running out of medication entirely.
One patient, Sam*, said she had been without medication for 10 days after her prescription didn’t show up.
In February, the pharmacy had been unable to fulfil her regular prescription and arranged for a replacement product containing lower levels of THC.
The next month’s prescription, which was due to be delivered on 16 March, never arrived and Sam claimed that she struggled to make contact with anyone at the dispensary to find out why. When Cannabis Health spoke to her on 25 March she had still not received it, but was expecting a delivery the next day.
“My anxiety is through the roof,” said Sam, who is prescribed cannabis for PTSD, and struggles with anxiety and depression, as well as living with symptoms of systemic lupus, fibromyalgia and chronic fatigue.
“I had managed to control it for many months with cannabis, but I need the continuity. All of the strides that I had made with my mental health have taken a backward step.”
She continued: “I’m not sleeping any more, my nightmares are back and I’m struggling to regulate my emotions.
“All of my physical issues are getting worse again because cannabis is a big help with the inflammation. But my main concern is my mental health, physically I can be falling apart, but if my mental health isn’t right, what’s the point?”
The stress and uncertainty around what was going on with her prescription made matters worse for Sam.
“These are things I can’t control. I can’t get any communication from anyone at the clinic and I still haven’t gotten any information out of [the dispensary] whatsoever,” she said.
“I do feel hugely let down by the system. This is something that should be helping me and instead it has created huge amounts of anxiety.
“I came off antidepressants because I was able to live a normal life thanks to cannabis but I can’t imagine that the NHS would ever leave someone without mental health medicine.”
As the awareness of medical cannabis grows and demand increases, Sam believes that the current system is unable to cope and the care patients are receiving is suffering as a result.
“I don’t think that the process was fully thought through [when the law changed],” she added.
“It seems like more people are aware of cannabis medicines now and are seeking them out, but unfortunately that means my care is decreasing.
“Resolving the supply chain and ensuring that there are checks are in place to ensure that the patient isn’t being left without is hugely important.”
Hannah Deacon, co-founder of the Medical Cannabis Clinicians Society and cannabis consultancy firm Maple Tree, whose son Alfie Dingley relies on a prescription for medical cannabis, was recently faced with a similar prospect.
Following the end of the Brexit transition period, Bedrocan products from the Netherlands could no longer be legally imported into the UK, leaving dozens of patients who rely on these oils for severe epilepsy at risk of losing access to their medication.
The Dutch government confirmed it would continue to supply these medicines until July while a “long-term” solution was reached. But there is still uncertainty about what will happen after this date.
As the UK cannabis industry continues to grow, Hannah believes companies must put patients first and their needs should be at the heart of the sector.
“The creation of the cannabis sector is vitally important for many millions of patients in the UK, she said.
“However currently, the supply of products to patients is coming under extreme pressure due to many factors and sadly there’s only one victim – the patient.
“It is imperative that the sector does all it can to put patients first and ensure supply is available when needed and patients are not left without supply.
“We must not see the promise of products which then aren’t available as this is detrimental to the sector but mostly to the patients who rely on it.”
The cannabis patient advocacy group, PLEA (Patient-Led Engagement for Access) also says that supply issues have become a “major concern” for UK patients, with members of its Patient Working Group reporting similar experiences to Sam.
Advocacy director Lucy Stafford told Cannabis Health that there was an “urgent need” for changes in regulations to allow for mass importation of cannabis medicines into the country. But equally important is that products can be grown and manufactured on UK soil.
“Supply issues and delays are a major concern for medical cannabis patients,” she commented.
“Without consistent access to medication, patients can experience significant distress from the uncertainty and can quickly experience the return of debilitating symptoms, impacting health outcomes and quality of life.
“To resolve these issues, patients need access to a wide range of cannabis-based medicines on prescription. There is also an urgent need for changes in regulations to allow mass importation of cannabis-based medicines, as well as access to medications grown and processed in the UK.”
Last month it was announced that major European cannabis company EMMAC Life Sciences had partnered with Sapphire Medical Clinic to bring the first UK-manufactured EU GMP medical cannabis flower to patients. The company says it will use data collected from the clinic’S Real-World Evidence platform to inform its production and supply chain.
The UK Medical Cannabis Registry captures patient and product data and will allow EMMAC to respond to product effectiveness and increasing patient demands.
Meanwhile the digital chronic pain clinic Cellen, which has access to flower-based products, is said to be “working on solutions” with dispensaries to ensure supplies are consistent.
Clinical Associate Sarah Marten says the current issues are down to the amount of regulation importers are required to follow, which have been compounded by Brexit.
“There have been a lot of issues getting products into the UK recently, caused by the amount of regulation importers are required to follow to get these medicines to patients, she told Cannabis Health.
“It’s also my understanding that some changes in the working relationships with the European manufacturers and suppliers post-Brexit has made things more difficult.
Sarah also reports that patients have reached out to Cellen after struggling to get hold of these medicines from its competitors.
“We’re hearing stories of patients being left without their supply, and many are unaware that there’s another option,” she continued.
“At Cellen we think it is important that prescribers know what products are available and are working on a number of solutions with the dispensaries to ensure access to supply is consistent.
“As with any medication if it’s helping you to control your symptoms and it’s suddenly taken away, it can have repercussions. It’s vital that we make sure patients can get consistent access to their medications and we want to help wherever we can to get people these life-changing drugs.”
The very least patients deserve
Lyphe Group, which owns Dispensary Green, the pharmacy responsible for Sam’s prescription, is now piloting a new online ordering system which it says will provide “unparalleled levels of transparency”.
The digital system will allow patients to see exactly where their medicines are, from prescription to secure delivery, as well as itemising how much of each medicine is to be taken and how frequently.
“Patients deserve transparency and an easy pathway to receive their medication once they have their prescription. After all they have been through it is the very least they deserve,” said managing director, Jonathan Nadler.
The company, which has managed more than 75 imports from countries across the globe admits there has been “teething issues” with the industry, but expects things to improve quickly, as it now has access to all flower-based products on the official list of cannabis medicines.
“Since the industry in the UK began, the supply of medical cannabis to patients has been fragmented. There have been issues around every corner with producers and regulators but Lyphe are the leaders in the space, we help the most patients in the UK get to this medicine as efficiently as possible,” he said.
“We have also been the leading supplier of products on a wholesale basis to other operators in the industry where they have been unable to procure products. We are laser-focused on constantly improving our services and moving the industry forward, and won’t stop until every patient, who needs it, has access to medical cannabis.
“Moving large volumes of legal cannabis across the globe is hugely complex. However, we have now managed more than 75 imports from countries like Israel, Australia, Canada, and a few EU member states.”
Lyphe is also expanding its patient support service team, which currently has 28 members, to meet demand.
“Our team is working around the clock to help thousands of patients every month – they are the heroes who are committed to overcoming daily adversity to help our patients through the process,” said Jonathan.
“Sometimes patients will have to wait for their medication to arrive longer than expected. This is always out of our control and usually down to regulators responsible for export, however we fully appreciate the impact this has on patients and we work quickly to overcome these instances directly with the patient.
“As product supply improves – we have stock of every flower on the formulary – which it now has, these teething issues will fade away very quickly.”
PLEA added that any patients experiencing supply issues should contact their prescribing doctor who can assist in finding a suitable alternative medication.
*Sam’s name has been changed to protect her identity
“CBD allows me to function” – biker ‘died’ three times after freak road accident
After a serious motorbike accident, Gary Brennan almost lost his life, undergoing 54 operations to fix his broken body. Gary speaks to Cannabis Health about the “life-changing” accident and how CBD helps to manage the pain 11 years on.
On February 28th 2010, Gary Brennan collided with a car while riding his motorbike.
He broke both shoulder blades, tore his liver, crushed his kidney, shattered his pelvis fractured his spine and suffered from bleeding on the brain and a collapsed lung.
These are just some of the life-threatening injuries that he sustained in the accident.
So severe were his injuries that he was declared dead at the scene of the incident. Paramedics were able to resuscitate him before he was helicoptered to Leeds General Infirmary where he underwent emergency surgery.
During the operation, his heart stopped twice and his family were told that he may have just a few hours to live. He was put into an induced coma and relied on a life support machine to breathe.
Miraculously, Gary survived.
His condition stabilised enough to come out of the coma, but since then he has undergone a total of 54 operations.
When Gary’s condition stabilised enough to come out of the coma he was in excruciating pain. Having battled injuries that doctors deemed barely survivable, the 63-year-old was administered a plethora of drugs to keep the pain under control and has since undergone a total of 54 operations.
“The accident was life-changing to say the least,” Gary told Cannabis Health.
“I got through the operations and everything else, and then I got to the stage where I was lying in bed, zoomed out my head every day of my life with the drugs that I was taking.”
The cocktail of medications including morphine and ketamine kept the pain at bay but according to the father-of-four, it was “destroying” his brain.
Bed-bound, in pain and suffering from a relentless medication plan, Gary slipped into a period of depression and at one point considered suicide.
“I don’t say this lightly,” he said. “It brings tears to my eyes just thinking about it; that I actually even considered it having been a fit, active father-of-four and grandfather-of-six.
“But that was what the drugs were doing to me.”
Gary recalls waking up in the morning “groggy as hell” and in agonising pain until he took his medication.
“All it would do was numb my mind so that I didn’t feel the pain,” he added.
Knowing he had to find an alternative, he looked into CBD.
Although he was sceptical at first and questioned whether the benefits were merely a placebo effect, Gary found that CBD was helping reduce the pain while still allowing him to keep a “clear” head.
“Now I’ve got clarity, I’ve got a clear head, I can get out of bed in the morning. I still get the twinges but it’s not as severe pain,” he continued.
“The pain is always going to be there, but it’s handled in a different way. It doesn’t numb your brain, but the actual place that’s aching. It gives me relief and allows me to function.
“It changed my outlook on pharmaceutical drugs.”
Gary has now come off all prescription drugs apart from one, which he takes “now and then” to lower his blood pressure. Instead, he takes four capsules of CBD each day, equating to 720 milligrams.
Eleven years on from the crash, he has founded his own CBD brand, Brain Body Balance, and is working with US company, Ananda Scientific, to bring its patented Liquid Structure CBD formulation to the UK.
Ananda claims that the nano-sized technology makes its CBD formulation up to 20 times more bioavailable in the first 30 minutes than standard CBD. This is down to its “non-destructive” shell which contains the CBD and is able to pass through the gut and liver without being broken down. The shell only disintegrates when it reaches the small intestine, allowing for a greater amount of CBD to enter the bloodstream.
Ananda’s pharmaceutical-grade CBD is currently undergoing clinical trials to test its efficacy for treating pain, diabetes and mental health conditions including PTSD and anxiety.
Meanwhile, the nutraceutical arm of the company has launched over-the-counter products in the UK and the US through brands like Brain Body Balance.
For Gary, producing a product with high bioavailability was a priority.
“I knew the product itself worked, but actually getting it into the bloodstream where it does its job is the hardest thing to do,” Gary said.
“You have to use stronger and stronger doses in order to get it into your bloodstream.”
Alongside his CBD venture, Gary set up the charity, Day One Major Trauma Support to limit the impact of trauma on patients and families in hospitals across Leeds and the wider Yorkshire area.
“When I was lying in hospital, the doctors would come around once a day and say, ‘how are you feeling, Gary?’, ‘can you feel your toes?’. Then they would say, ‘see you tomorrow’ and off they go,” he said.
“The nurse comes around, gives you your pills, then your family come in, pat you on the head and say it’ll be okay. Basically, that’s all you get.”
Aware of the lack of support, Gary set out to create a service that helped those like him who had suffered from major trauma. The charity provides financial assistance, legal advice and practical and emotional support.
Off the back of its success at Leeds General Infirmary, the charity will now be rolling out its services in all 27 major trauma centres in the UK.
Gary added: “Any help is there first-hand, no matter what, so nobody’s left in the lurch.”
My experience as a medical cannabis prescriber on Project Twenty21
In the second of a two-part series, Cannabis Health speaks to Dr Rebecca Moore about her experience as a prescriber on Drug Science’s Project Twenty21.
Project Twenty21 is a landmark scheme that seeks to widen access to medicinal cannabis and build Europe’s largest body of evidence for its efficacy.
Launched in November 2019 by the UK drug advisory committee, Drug Science. In August 2020, the patient registry handed out its first medical cannabis prescription.
A medical cannabis prescription is notoriously difficult to access on the NHS. In fact, an Advisory Council for the Misuse of Drugs (ACMD) report from 2020 revealed that less than five have been handed out by the health service. Meanwhile, those who can afford private healthcare can sometimes be left forking out thousands of pounds per month for a prescription.
The prescriber’s perspective
Dr Rebecca Moore, a consultant psychiatrist specialising in trauma and PTSD, is one of the doctors prescribing through the scheme. With a particular interest in women’s mental health, Dr Moore co-founded Make Birth Better, a campaigning group on a mission to make women’s experience of pregnancy better.
CH: What got you interested in medical cannabis?
RM: I’ve been aware of medical cannabis for quite a few years now. At university, I had a friend who had a cancer diagnosis. I watched her use cannabis and saw how helpful that she found it for her symptoms.
My expertise is in general psychiatry, but particularly around trauma and PTSD. I think that’s why I was drawn to medicinal cannabis prescribing; I’ve seen a lot of research around its use with trauma.
During my training, and more recently, I’ve been lucky enough to be able to go and shadow some colleagues in America and see them prescribing medicinal cannabis.
And I was really astounded at the efficacy of that for people. People coming back and reporting that it had helped them with so many different aspects of their life: pain, sleep mood. I was really interested and intrigued by that, and wanted to be part of this when it was possible in the UK.
CH: What kind of patients do you work with as part of Project Twenty21?
RM: I see a wide range of patients coming to see me in the clinic. They often have a very long history of contact with mental health services or with their GP and might be presenting with anxiety, low mood, trauma and lots of other presentations.
What is often a common theme is people that have tried lots and lots of things in the past and never really felt that they have been particularly helpful for them. They might have tried numerous prescribed medications, different types of therapy, exercise, but never really found the right thing that they felt controlled all their symptoms or improved their quality of life.
I really feel that medicinal cannabis is something that we should be talking about with people because for many people, it can be a really good choice in their treatment.
CH: Why were you excited to get involved with Project Twenty21?
RM: I felt really passionate [about the project] because I had seen how helpful medicinal cannabis could be for many, many people. And as it’s very new in the UK, it was really exciting to be part of something that is at the forefront of what I believe is going to be one of the most important fields of medicine over the next decade.
CH: What is the importance of data in prescribing medical cannabis?
RM: It was really important for me to be part of this project because of all the amazing data that this is going to give us as it progresses.
I think one of the key things as a medicinal cannabis prescriber is being asked about data and where the evidence is. The fact that we have this wonderful project that’s capturing data from people presenting lots of different conditions is so important to me because I want to be able to give people this evidence about how cannabis might help them and how it might help with particular symptoms.
CH: What are your hopes for Project Twenty21?
RM: The people that I’m working with really like feeling that they’re part of this project and they’re contributing to something that’s going to be really helpful for others. There’s a real sense of people wanting to help.
I hope that it means that we have this amazing array of data, which we can use to transform the way that medicinal cannabis is prescribed. And clearly, the end goal for me is that I would really like this to be available for people on the NHS so that there is equity of access for anybody who wants to consider it as a choice.
And alongside that, there’ll be data that can be published so that everybody across the world can learn from this.
If you’re a clinician who would like to know more about becoming a medical cannabis prescriber with Project Twenty21, please email email@example.com
Matthew Taylor shares his experience as a patient on Project Twenty21 here
Find out more about joining here
- “I feel hugely let down by the system”: Patients fall victim to UK’s cannabis supply issues
- Does CBD affect endometriosis?
- “CBD allows me to function” – biker ‘died’ three times after freak road accident
- How much CBD should I take?
- My experience as a medical cannabis prescriber on Project Twenty21
- More than half Americans don’t know the difference between CBD and THC
News9 months ago
NHS lines up cannabis medicine manufacturing
News5 months ago
Community extends support to cannabis icon Rick Simpson
Case Studies1 year ago
CBD oil and fibromyalgia – a case study
Feature10 months ago
Medical cannabis could help long-term effects of COVID-19, says David Nutt
Insight6 months ago
I’ve gone from a wheelchair to walking thanks to cannabis
News7 months ago
Cancer survivor claims cannabis oil helped her beat brain tumour
News7 months ago
“I’m not a bad person” – chronically ill woman convicted of growing medical cannabis
Industry2 months ago
Cannabliss to open brick and mortar dispensary