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Largest human trial seeks to prove safety of full-spectrum CBD

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Current European guidelines on THC are based on two small studies conducted in 1993 and 2011

The European Industrial Hemp Association (EIHA) has launched the largest human trial on the toxicological effects of trace amounts of THC in food products – but will it be enough to persuade regulators to approve full-spectrum CBD?

With an investment of 1.6 million Euros, the EIHA will assess 200 participants across a 30-day period in an effort to demonstrate to European regulators that trace THC is safe to consume.

Results from the study are expected to be released in the summer of this year.

Last month, the EIHA submitted three novel food applications on behalf of its members to both the European Food Safety Association (EFSA) and the UK’s Food Standards Agency (FSA).

These included an application for isolate-based, synthetic and full-spectrum CBD products.

Although the EIHA are in full agreement with the European Commission that isolate-based CBD should be classed as a novel food, it argues that full-spectrum products should not fall under the same regulations.

Lorenza Romanese, managing director at EIHA

Managing director at EIHA, Lorenza Romanese, told Cannabis Health: “When it comes to low levels of cannabinoids in food, this has been sold on the market for 25 years.

“It is not novel. For us, these do not deserve any novel food application prior to putting them on the market.”

According to Romanese, the full-spectrum application will be the organisation’s biggest challenge. Full-spectrum products contain the entire range of compounds found in the hemp plant, including trace amounts of THC.

In some cases, full-spectrum CBD products contain a larger concentration of THC than what is permitted under current guidelines.

However, Romanese believes that these guidelines are “wrong, old and outdated”.

European guidelines on THC are based on just two studies. The first was conducted in 1993 with a cohort of thirty-one HIV patients. The second study, conducted in 2011, involved just eleven participants.

“They are completely ignoring 30 years of literature around cannabis,” she said.

“If we really believe that the full spectrum is the right product for the market, we need to tackle THC.”

With its ground-breaking study, the EIHC aims to fill the gap in scientific research surrounding the psychoactive compound found in hemp and cannabis.

“Full-spectrum is a challenge because there are some studies that are missing,” Romanese said.

“This is why we have decided to stick together and invest this money on behalf of our members, and in the name of the sector, to dig into this scientific topic that deserves toxicological studies.”

To ensure the results of the study are as safe and reliable as possible, the researchers will multiply its findings for uncertainty factors.

This number is fixed for certain substances.  For example, alcohol requires no multiplication. Meanwhile, Nicotine has an uncertainty factor of 4.4 and codeine has a factor of 5.

The uncertainty factor for THC, on the other hand, is between 20 and 40, almost ten times higher than nicotine and codeine.

Romanese hopes that the ongoing toxicological study will make regulators more comfortable with the concept of full-spectrum CBD and allow for its members to continue producing and selling products containing trace THC.

However, if its full-spectrum application is not accepted, the association says it will not stop there. Following the initial decision is a nine-month period referred to as ‘assessment’ in which applicants can negotiate and debate with decision-makers.

“What I hope is that [regulators] will not reject full spectrum on principle. I will be very upset if they are not embracing science.

“The application takes a lot of work so it should not be refused on principle. They have to [explain why]. It will then be a negotiation with them to understand their decision.”

The EIHC was formed to support the three main families of the hemp sector: farmers, processing companies and traders.

Alongside its efforts to support companies through the novel food application, the organisation is also promoting hemp as an agricultural product and working to establish a clear legislative framework for the hemp plant.

In 2019, the European Commission launched the Green Deal, a project that aims to make Europe more sustainable while continuing to grow economically. Romanese says hemp can play an integral role in these ambitions.

“Climate change is here, and we need to tackle it. Hemp means no pesticides and little, if no, fertilizer. And on top of that, hemp helps the soil, the biodiversity, the pollinators and it stocks a lot of CO2 in the soil.

“The future of hemp could be bright. It’s super beneficial for the entire planet and I feel very proud to represent something that is very green, clean and supportive for the objectives of the Green Deal.”

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“I feel hugely let down by the system”: Patients fall victim to UK’s cannabis supply issues

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Portrait of anonymous patient
UK medical cannabis patients report being left without medication as prescriptions are delayed

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.”

Brexit blockades

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.

Hannah Deacon and son Alfie Dingley.

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.”

Home-grown cannabis

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.

Another option

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

 

 

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“CBD allows me to function” – biker ‘died’ three times after freak road accident

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Gary Brennan pictured with wife Shirley
Gary Brennan and wife, Shirley set up a trauma support service after the 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.

Gary Brennan underwent more than 50 operations

“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.

Gary with one of his six grandchildren.

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.”

 

 

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My experience as a medical cannabis prescriber on Project Twenty21

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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 prescribers@drugscience.org.uk

Matthew Taylor shares his experience as a patient on Project Twenty21 here

Find out more about joining here

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