Cannabis Health issue five by aspectpublishing

ISSUE 05

Covering cannabis medicine and wellbeing from every angle

Why women in pain are turning to cannabis medicines

‘Medical cannabis was my daughter’s last hope’

Do CBD users feel less stressed?

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Living well in the new normal with CBD and medical cannabis CH-Q1IS05-2509

Over the next decade the cannabis industry is set to be one of the fastestgrowing, dynamic and controversial parts of the world economy. Medical cannabis, plant-based lifestyle products and recreational liberalisation are not hypothetical concepts anymore - they are facts of life. After several months of planning and preparation, our new website ‘Cannabis Wealth’ is now live and ready to be your one-stop shop for news on cannabis-based business, investment and all the big policy and regulatory updates.

Why are we different? Created and run by experienced journalists, we’ll dig deeper than press releases and ask important questions about the industry. You may already know our sister-title, Cannabis Health, a go-to read for people interested in the wellness potential of cannabis-based products.

In the coming weeks and months we’ll be launching new sections, features and bringing on board guest columnists from across the industry.

You can visit Cannabis Wealth by going to

www.cannabiswealth.co.uk @Cannabis_Wealth

Got a story? Get in touch with the editor at sean@handwmedia.co.uk or Twitter: @seddonnews

Do you have a commercial query? Contact gary@handwmedia.co.uk

WELCOME

Covering medical cannabis from every angle in print and online. Cannabis Health is delivered every quarter to people across the UK interested in the potential health benefits of cannabis medicines and wellbeing products. It is supported by an editorial panel of experts. Our directors and editorial advisors include:

Hannah Deacon

Hannah successfully campaigned to enable her epileptic son Alfie Dingley to legally receive cannabis medicine. She continues to campaign to help more families access medicinal cannabis in the UK. and is director of the Medical Cannabis Clinicians Society

Professor Mike Barnes

Mike obtained the first medicinal cannabis licence in the UK for Alfie Dingley, and has been involved in efforts to assist many others. He is the founder of the Medical Cannabis Clinicians Society.

For a free* postal subscription visit cannabishealthnews.co.uk For advertising enquiries contact gary@handwmedia.co.uk Send your stories and opinions to sarah@handwmedia.co.uk

Also on the Cannabis Health team: Andrew Mernin, Editor-in-Chief | andrew@handwmedia.co.uk Sarah Sinclair, Managing Editor | sarah@handwmedia.co.uk Gary Wilding, Head of Advertising | gary@handwmedia.co.uk Paul Newton, Operations and Finance Manager Millie Newton, Social Media Contributors: Joe Roberts, Sean Seddon, Jenn Brown

For regular updates on all things medical cannabis visit cannabishealthnews.co.uk

WELCOME

Editor's comment If the past year has taught us anything it’s the value of our health, writes Sarah Sinclair. A year on from the first UK-wide lockdown and we are slowly beginning to emerge from the darkness, but the real toll that the pandemic has taken on our health is only just beginning to show. Figures from the Government’s Covid-19 Mental Health and Wellbeing Surveillance Report found that average mental distress was 8.1 percent higher in April 2020 than it was between 2017 and 2019. The proportion of people experiencing sleep problems has unsurprisingly also increased, with loneliness, health anxiety, financial worries and too much screen-time all to thank. Being young and female also had the strongest link to psychological distress and one study found that adults with long term physical health conditions reported worse levels of depressive symptoms than those without. We’re still to see the true extent of the cancelled operations, delayed appointments and missed check-ups due to the pressure Covid has placed on the NHS. And then there’s the physical impact of a year spent working from make-shift offices in spare bedrooms and on sofas (she writes hunched over a laptop). Many of those who have had the privilege of a job they can do from home now have the back ache to prove it. With mental health services on their knees and waiting lists only getting longer, more people than ever are looking for another option. A US survey of 20,000 CBD users released in April 2021 revealed that 89 percent used the supplement for the first time during the past six months. UK companies have also seen CBD sales soar since the first lockdown, with the majority using it to help with insomnia and anxiety. Pain relief isn’t far behind. Women, particularly those living with long-term, complex conditions are increasingly turning to alternative therapies, with cannabis often cropping up as one of the most effective. Gender bias in traditional medicine means this demographic are more likely to have their pain dismissed and as a result

female-specific conditions often go untreated and undiagnosed. We will explore this in a new webinar series beginning in May, on the role of medical cannabis in women’s health. With a panel of expert clinicians and patients sharing their lived experience, we hope it will be the first of many live events lifting the lid on this exciting new field of medicine and informing more patients and prescribers about what could be potentially lifechanging treatments. The first event will take place on Wednesday 12 May at 7pm, you can find out more on page 52. Hope to see some of you there.

For more regular content and to sign for your free subscription to the magazine visit www.cannabishealthnews.co.uk and follow us: @CannabisHNews @cannabishealthmag for daily updates. Sarah Sinclair, editor, Cannabis Health sarah@handwmedia.co.uk

Cannabis Health is produced by H&W Media Ltd. Registered company in England and Wales (number 12235652 / registered office: 11 Lansdowne Terrace, Newcastle upon Tyne, NE3 1HN) DISCLAIMER: This publication is intended for an 18+ audience. The comments and opinions given by contributors, quoted sources and interviewees are not the views of the editorial team or publisher unless otherwise stated. This is an editorial magazine, not a peerreviewed medical journal. Anyone interested in accessing medicinal cannabis is urged to consult their GP first. Cannabis Health cannot accept liability for any issues or comments raised by individuals featured in this publication.

CONTENTS

08 N E W S

3 6 B R E A K I N G BA R R I E R S

The biggest news from the UK medical cannabis sector and beyond

Parents welcome new NICE guidelines

4 2 T H E OT H E R E P I D E M I C Is access to cannabis the key to tackling the opioid crisis?

4 8 M Y DAU G H T E R’ S L A S T H O P E One mother’s journey to get her daughter life-changing medicine

CONTENTS

5 2 WO M E N I N PA I N

70 L I V I N G W E L L

Why women living with chronic pain are looking for another option

How CBD is helping us cope with the new normal 7

SELL

6 2 PAT I E N T VO I C E S Patients reveal what medical cannabis means to them

76 G R E E N R US H What next for the cannabis industry?

BUY

NEWS IN BRIEF

The biggest news from the UK medical cannabis sector and beyond. 8

New industry report demands ‘meaningful change’ A new in-depth report looking at the state of medical cannabis in the UK has set out a ten-point programme of reform for the Government. The paper, jointly published by Maple Tree Consultants and Mackrell Solicitors, calls on policymakers to ‘make meaningful, progressive changes to the outdated laws and regulations hindering the industry’. It also warns that without significant reform, the industry is at ‘serious risk of being subject to a pharmaceutical monopoly’ by a handful of large firms with the resources to navigate the UK’s stringent restrictions. Recommendations include reforming the high-THC cultivation license system, allowing CBD brands to make justifiable wellness claims, reassessing NICE guidelines and permitting GPs to prescribe medical cannabis. Read the 10 recommendations for Government at: www.mapletreeconsultants.co.uk/ten recommendations

MPs campaign to end ‘50 years of drug failure’ A campaign to overhaul the Misuse of Drugs Act ahead of the 50th anniversary of its passage into law has won cross-party support. The controversial act was passed on 21 May, 1971 and still serves as the cornerstone of British drugs legislation. After half a century, the Transform Drug Policy Foundation says it is time for a rethink. More than 40 MPs and peers of all political persuasions are supporting the campaign’s calls to overhaul domestic drug laws, including former Green Party leader Caroline Lucas and Conservative MP Dan Poulter

Without reform the industry is at ‘serious risk’ of being subject to a pharmaceutical monopoly

NEWS IN BRIEF

UK is world’s largest medical cannabis producer The United Kingdom has been singled out as a major producer of medical cannabis by a United Nations (UN) report. The International Narcotics Control Board estimates that the UK produces about 320 tonnes of cannabis for pharmaceutical purposes. The UN body described the UK as a ‘major’ player in the industry but the Government is accused of hypocrisy by campaigners over how few patients can actually access the products. The report also slammed the Government for not providing full data when requested, leaving the report’s authors needing to devise estimations of UK production.

Parkinson’s patients report benefits of cannabis More than half of patients with Parkinson’s disease who consume cannabis have found it to be beneficial, according to a German survey. Over eight percent of patients with the disease reported using cannabis products and more than half of those (54 percent) reported a beneficial clinical effect, according to results published in the Journal of Parkinson’s Disease. Researchers performed a nationwide, questionnairebased survey among members of the German Parkinson Association. Over 40 percent of users reported that it helped manage pain and muscle cramps, and more than 20 percent of users reported a reduction of stiffness, freezing, tremor, depression, anxiety, and restless legs.

Love Hemp gets ahead of the game UK CBD and hemp product supplier, Love Hemp Group secured an exclusive multi-million-dollar global partnership deal with Ultimate Fighting Championship (UFC). The partnership, which will come into play on 1 June, 2021 includes marketing and sponsorship opportunities, set to put Love Hemp in the top tier of international brands. UFC boasts more than 625 million fans worldwide, with programming that is broadcast to over 170 countries and territories, in 40 different languages, to over 900 million TV households.

GW Pharma sells for $7.2 billion In what has been described as a “turning point” for the industry, GW Pharmaceuticals has been bought by JAZZ Pharma for $7.2 billion. GW Pharma has held the monopoly on the UK market, as the producer of one of the few licensed cannabis- derived medicines, Epidiolex. Nawan Butt, Portfolio Manager of The Medical Cannabis and Wellness UCITS fund – Europe’s first Exchange Traded Fund (ETF) focused on cannabis – said the deal marked a “notable turning point” for the sector and predicted this would be the first of more acquisitions to come.

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The Jiu Jitsu enthusiast tackling CBD stigma in Black and Asian communities Syed Das, a Brazilian Jiu Jitsu enthusiast, found CBD helped him recover from an arduous training regime and introduced his parents to it after they were involved in a serious car accident. Now through his company, CBD Britanicare, he’s tackling the taboo of CBD amongst black and Asian communities. 10

Nine years ago, Syed’s parents were involved in a major car accident. Amongst a number of serious injuries, his mother suffered from an open fracture in her forearm and underwent surgery on her wrist. Syed recalls she was prescribed heavy medications, including Gabapentin and Tramadol, which came with a range of crippling side effects, including severe anxiety which later led to suicidal thoughts. “She wasn’t herself; she was in a daze most of the time and was really short tempered,” Syed tells Cannabis Health. At this point, CBD was still relatively unknown. Syed first heard about the cannabidiol compound while studying for his master’s degree in pharmaceutical science at University College London and later started using creams and oils after intense sessions of MMA and Brazillian Jiu Jitsu (BJJ) training.

The 33-year-old has been practicing the martial art for six years, training as often as three or four times a week at the Grappler’s Den in South London. He recently earned his BJJ purple belt, regarded as one of the toughest ranks to reach in the sport. With such a physically demanding hobby, Syed has had his fair share of injuries over the years, but he says CBD has helped him stay on top form and maintain his health and wellbeing. He uses CBD oil to improve his sleep and aid his recovery, while CBD-infused creams offer more targeted relief when recovering from injuries, he says. Several years after the accident, as his mother continued to suffer from the side effects of her medication, Syed suggested she try CBD. “She had all these injuries and nothing was working for her,” Syed says. “She suffered from a lot of anxiety just from travelling in a car and had nightmares and insomnia as well. “It was quite extreme at that point, so I was exploring alternatives to your typical over the counter and prescription medicines.” It was an incredibly difficult time for his family, Syed said, but his mother did eventually find relief with CBD, which allowed her to come off the opioid medications that were having such a detrimental impact on her life and wellbeing. Seeing how much his mother had benefited from the supplement, Syed was “spurred on’’, to start his own company, CBD Britanicare, and “share CBD with the nation”. “It has really helped her and now, I want to share that with as many people as possible,” Syed adds. With a professional background in pharmaceutical

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regulation, Syed was well-equipped to start his own premium CBD company which he launched in the midst of the coronavirus pandemic. He began his career working for the pharmaceutical giant, Nurofen in Hull, before moving on to work for niche pharmaceutical firms in London. He primarily dealt with patient safety, medical writing and substantiating patient information for a range of different medications and food supplements. Having been embedded in pharmaceutical regulation for just under a decade, he says his background has helped him build CBD Britanicare on solid foundations. “With my background, I think I was able to register all the information quicker and in greater depth,” Syed says. “I’ve seen some people in the industry make quite a few mistakes, so I’m very careful with the advertising and marketing of the products. “We want to reassure the public that we’re following regulations and guidelines from the government and the Food Standards Agency, while ensuring that all our products are lab tested and manufactured to the highest standard.” CBD Britanicare produces a range of oils, from isolates to full spectrum using an olive oil base sourced from Greece and Hemp from the UK. The family-run business also produces capsules, cosmetics, e-liquids and hempinfused teas. Although Syed’s mother was willing to give CBD a try, his father was sceptical. Coming from a British Asian background, Syed says CBD and medicinal cannabis is “looked down upon” in the British Asian community and his dad was against the

idea of using a product associated with the illegal drug. However, after being diagnosed with early-stage bowel cancer last year, he eventually came around to the idea and started taking his son’s own products to help him during treatment. His father’s distrust of CBD is common amongst black and Asian communities, Syed says. With the launch of CBD Britanicare, one of his primary aims is to eradicate the taboo so more people like his parents can discover the benefits of CBD. “Cannabis is viewed as something negative, particularly amongst the older black and Asian communities in the UK,” he says. “With CBD Britanicare, I really wanted to do away with that stigma and introduce CBD into these communities.” CBD Britanicare is teaming up with influencers from black and Asian communities to help promote CBD, including Solomon Lefleur, Queensbury Boxing Champion & ISKA World Champion Kickboxer, and Ajmal Khurram, a social media influencer, personal trainer and wellness coach. Alongside its new partners, CBD Britanicare aims to tackle the stigma and get more people using the supplement who may have otherwise dismissed it. Syed adds: “We’ve already partnered with influencers across the country who have built up a big following; mainly people in the communities who are into sports, bodybuilding and MMA. They’ve used and reviewed our products, and many were surprised themselves at how much they benefitted.” With the passion and determination to tackle misconceptions, CBD Britanicare is one to watch! For more information about the company and products visit www.cbdbritanicare.co.uk and keep up to date by following them on all social media platforms.

NEWS IN BRIEF

Novel foods leaves CBD industry in limbo

Europe’s cannabis market to hit €3.2 billion by 2025

The CBD industry has been plunged into a state of confusion by the Food Standards Agency’s (FSA) handling of the novel foods process. Companies scrambled to get dossiers of safety and quality data ready for the 31 March deadline, ahead of the imposition of new rules on the sector. On 19 April, the FSA published its first public register of products which have been ‘validated’, meaning they can continue to be sold in the UK pending a further decision on full authorisation. But stakeholders were shocked to discover just 23 products from three different companies were included on the first public register. The FSA has confirmed to Cannabis Health that the register will be updated weekly and they don’t expect it to be completed until June, leaving companies facing the prospect of being stuck in regulatory limbo for weeks or months. At the time of going to print, just four brands have been successfully added to the list.

Industry consultants Prohibition Partners expect greater patient access across the continent to fuel a 64 percent growth rate over the next four years. Germany will continue to dominate the European market until 2024 but the UK and France are predicted to make up a bigger share towards the end of the period. The UK medical cannabis market could show the most significant growth of any country in Europe by 2025 if regulations continue to open up, the analysis finds. Around 60,000 European patients accessed medicinal cannabis products for the first time in 2020, bringing the total number of patients on the continent to 185,000.

The CBD industry has been plunged into a state of confusion

NEWS IN BRIEF

Scotland’s first cannabis clinic opens Sapphire Medical Clinic has become the first cannabis clinic to be approved by Scottish regulators in a landmark and potentially “life-changing” moment for patients. The award-winning clinic is now authorised to provide safe access to medical cannabis for patients in Scotland after receiving Healthcare Improvement Scotland (HIS) registration. The clinic is located in One Allan Park Wellbeing Clinic, Stirling, in the central belt of Scotland with initial appointments taking place from March. 13

In other news for Sapphire Medical Clinics, it has partnered with Europe’s largest independent cannabis company, EMMAC Life

Sciences, to bring the first UK-manufactured flower to patients. The partnership will initially see EMMAC launch a new cannabis flower product, followed by a further range later this year, in response to identified patient demand.

More than half of Brits back legalisation Results from a YouGov poll conducted in April, showed that 52 percent of British people would be in favour of cannabis legalisation. Just 32 percent of respondents said they would oppose the legislation, while 15 percent answered that they didn’t know. It came after London Mayor Sadiq Khan said he would launch a review looking into decriminalising the drug if reelected on 6 May.

NEWS IN BRIEF

Cannabis reduces need for prescription meds in MS patients

Firms reject 0.03 percent THC recommendations In March, the Association for the Cannabinoid Industry (ACI), Centre for Medical Cannabis (CMC) and the Conservative Drug Policy Reform Group released a paper suggesting a 0.03 percent THC limit should be adopted by the UK Home Office. Under the proposals, CBD products and hemp strains below those levels would be exempted from controlled status. But a letter by four key industry bodies representing over 1,000 businesses warns the move would be a “disaster” and is too stringent to allow the UK hemp sector to grow. The letter is co-signed by the British Hemp Alliance, Cannabis Trade Association, Northern Ireland Hemp Association and Scottish Hemp Association.

The majority of multiple sclerosis (MS) patients who consume medical cannabis report that it offsets symptoms of the disease and reduces their need for prescription medications, according to survey data published in the journal Multiple Sclerosis and Related Disorders. A team of investigators from the Yale University-Griffin Prevention Research Center surveyed 115 MS patients about their consumption of cannabis. Respondents were most likely to report that cannabis was effective in reducing symptoms of pain, insomnia, muscle cramps and spasms, as well as improving mood. Consistent with studies of other patient populations, “a significant proportion of respondents” reported having either “stopped or reduced” their use of prescription medications after finding cannabis to be more effective for symptom management.

Cannabis in the courtroom The world’s first industrial hemp wig will see cannabis make its mark in the courtroom for all the right reasons. Vegan trainee barrister Samuel March has partnered with hemp textile designer Laura Bossom, to create the first locally-made industrial hemp wig. Set to be manufactured in the UK this year, the wig will be rolled out as legal wear to be worn in courts around the country.

The majority of MS patients who consume medical cannabis report that it offsets symptoms of the disease

NEWS IN BRIEF

Northern Leaf secures license to grow high-THC medical cannabis A Channel Islands firm has successfully obtained the first commercial UK medical cannabis license for over 20 years. Jersey company Northern Leaf Ltd has secured the first full THC cultivation license to produce EU-GMP grade medical cannabis for the UK and European market. The license, issued by the Jersey government under the guidance of the UK Home Office, is the first to be granted since GW Pharmaceuticals in 1998. Commercial production is set to commence in 2021 at Northern Leaf, with a 75,000 square ft operational facility already built and the capacity to increase its greenhouse cultivation area to over 600,000 square ft.

Cannabis to generate £3 million annual boost for Isle of Man Leaders on the Isle of Man have backed a licensing system for the cultivation of medical cannabis on the island. The Isle of Man’s parliament, Tynwald, voted unanimously in January to approve the regulations which will allow for the cultivation of medicinal cannabis. The sector is estimated to generate around £3 million in annual benefit in the coming years, however the framework only relates to an export industry and there are no changes to domestic legality of prescription medicinal cannabis or the legality of non-medical adult use of cannabis in the Isle of Man.

Cannabliss opens bricks and mortar dispensary

The sector is estimated to generate £3 million in annual benefit

UK-based medical cannabis group Cannabliss, has secured a pharmacy licence for dispensing medical cannabis through its online platform and announced it would be opening a brick and mortar site in Preston in April 2021. The store will sell legal, over-the-counter cannabisbased products and also offer advice and guidance to people who are seeking to secure a medical cannabis prescription.

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The clinical trials roadmap Established in 2018, with medicinal cannabis cultivation & processing facilities established in Lesotho and under construction in Portugal, EuroCan is in the vanguard of the fast-growing, legalised medicinal cannabis industry. In this article, EuroCan’s Chief Technical Officer, Miguel Fagundes, a qualified pharmacist specialising in the pharmaceutical industry, gives his insight on the process of clinical trialing of new medical interventions, a topic which is of great relevance in the developing legal cannabis sector, from over-the-counter CBD products to pharmaceutical products prescribed by specialist medical professionals. 16

What is a clinical trial? A clinical trial is a research study conducted in humans with the goal of answering specific questions about new therapies, vaccines, diagnostic procedures or new ways of using known treatments (together referred to as “interventions”). Carefully conducted clinical trials are the fastest and safest way to find effective treatments that help people. Clinical trials are an integral part of the drug and diagnostics discovery and development process. Before a new intervention can be made available, evidence of its safety and efficacy must be proved by well-designed, well-controlled, and carefully monitored clinical studies in consenting participants. Randomized controlled study is the most reliable medicine study design.

What is measured in a clinical trial? Clinical trials are performed in human volunteers to provide answers to questions such as “does a treatment work?”, “does it work better than other treatments?” and “does it have side effects?” The plan/protocol for clinical trials will describe the results (“endpoints”) that will be measured and the type of information to collect; this is then shared with regulatory authorities to obtain marketing approval, which - when granted allows a company to market its product for sale. Clinical trials also provide important information on the cost-effectiveness of a treatment, the clinical value of a diagnostic test and how a treatment improves quality of life.

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How many phases are needed in a clinical trial? Clinical trials are conducted in phases. Each phase is designed to answer certain questions, while taking steps necessary to safeguard participants. Every treatment is usually tested in three phases of clinical trials (conducted according to Good Clinical Practice (GCP) guidelines)

before regulatory agencies consider the product to be safe and effective. Clinical trials for the drug candidate commence only after pharmacokinetics and pharmacodynamics have been studied. An overview of the phases of clinical trials can be summarised as follows:

Phase 1

Phase 2

Phase 3

Post-Marketing Surveillance Trials

What happens to the compound in the body from a safety & tolerability point of view

Safest and most effective dosing regimen for the medicine

Adequately confirm the benefit and safety of the medicine

Evaluate the long-term effects of the medicine

6-10 participants

20-300 participants

300 - 3,000 participants

Anyone seeking treatment

Using a small number of healthy participants, the goal is to study what happens to the investigational compound in the body from a safety and tolerability point of view. Study participants are monitored for the occurrence and severity of side effects.

Once the initial safety of the study drug has been confirmed in Phase I trials. Participants are given various doses of the compound and closely monitored to compare the effects and to determine the safest and most effective dosing regimen.

These studies allow for the safety and efficacy of the new investigational drug to be compared to other available treatments or placebo. As well as being tested in combination with other therapies. Information obtained is used to determine how the compound is best prescribed to patients in the future.

Once the medicine has received regulatory approval (or market authorization) these studies are designed to evaluate the long-term effects of the drug (broader efficacy and safety information). Under these circumstances, less common adverse events may be detected.

Relevance to cannabinoids? Until recently, despite the therapeutic qualities of cannabis which have been well known for many centuries, it has not been easy to carry out testing or research into medicinal cannabis products due to the prevailing legal restrictions. With the liberalisation of legislative and societal attitudes towards cannabis we expect that growing scientific interest will further explore the clinical relevance of the various

A DIVISION OF BOTANICAL HOLDINGS PLC www.botanicalholdings.com info@euro-can.eu / www.euro-can.eu

cannabinoids found within the cannabis plant, through clinical trials. As these controlled and scientifically designed studies and trials progress, we anticipate a range of positive results which will demonstrate product safety, efficacy and the potential to improve quality of life for patients, whilst also further educating both scientists and the general public into the potential benefits of cannabinoids.

NEWS

How high-CBD cannabis extracts could treat Covid-19 The anti-inflammatory properties of CBD could potentially be used to prevent and treat Covid-19, according to a new study.

Researchers reported that Cannabis sativa, especially extracts high in the anti-inflammatory CBD, has been found to alter gene expression and inflammation and harbour anti-cancer and anti-inflammatory properties. Working under a Health Canada research license, the authors of Aging-US developed over 800 new Cannabis sativa cultivars and hypothesised that high-CBD Cannabis sativa extracts may be used to reduce ACE2 expression in target COVID-19 tissues. ACE2 is a protein found on the surface of many cell types, which acts as the receptor for the coronavirus and allows it to infect the cell. Using artificial 3D human models of oral, airway and intestinal tissues, they identified 13 high-CBD extracts that decrease ACE2 protein levels. Some Cannabis sativa extracts also suppressed serine protease TMPRSS2, another critical protein. The study is important for future analyis of the effects of medical cannabis on Covid-19. The extracts of the researcher’s most successful novel high-CBD Cannabis sativa lines, pending further investigation, may become a useful and safe addition to the prevention and treatment of Covid-19 alongside other therapies. Similar to other respiratory pathogens, Covid-19 is

NEWS

Every possible theraputic opportunity needs to be considered and researched

transmitted through droplets from coughing and sneezing. However, aerosol transmission and closecontact transmission cannot be ruled out as means of disease spread. ACE2 is expressed in oral mucosa and enriched in the epithelial cells of the tongue. High levels of ACE2 expression in oral epithelial tissues suggests that the oral cavity could be highly susceptible to coronavirus infection, making them an important target for prevention strategies. Similarly, numerous studies have reported high levels of ACE2 in the lower respiratory tract. Higher levels of ACE2 expression, such as those seen in smokers and patients with chronic obstructive pulmonary disease, are associated with higher Covid-19 predisposition and enhanced disease severity. The research team, led by Dr Olga Kovalchuk and Dr Igor Kovalchuk, concluded: “While our most efficacious extracts require further validation through large-scale analyses, our study is important for future analyses of the effects of medical cannabis on Covid-19. “Given the current dire and rapidly developing epidemiological situation, every possible therapeutic opportunity needs to be considered and researched.” The study was published in Aging-US

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Largest human trial seeks to prove safety of full-spectrum CBD 20

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. 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 EIHA 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.”

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They are completely ignoring 30 years of literature around cannabis

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 five. 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 EIHA 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, adds Romanese. “The future of hemp could be bright. It’s 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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Giving consumers the full-spectrum With more and more health-minded consumers turning to CBD products, producers are asking a crucial question: What do customers want?

SpectrumLeaf have spent a long time thinking about this and have arrived at a conclusion which defines their products: Accuracy, simplicity and discretion. Their new Elevar Leafs product allows CBD users to take a highly accurate dose quickly and efficiently without any cumbersome packaging, any place, any time. Their proprietary technology involves introducing specific and carefully measured quantities of water-soluble CBD to a piece of microfilm no larger than a postage stamp. The consumer simply places the tab in their mouth and waits for it to dissolve, a quick and discreet way to take a 25mg dose of the compound. CEO Felix Sundström - who is based in Stockholm, Sweden

- told Cannabis Health why the customer’s perspective dominates how their new Elevar Leafs product works. He said: “From a consumer point of view, we want to offer people a product that is accessible and simple. “We try and avoid simply repeating what everybody else in the sector is doing and think of better ways of delivering CBD. We believe the functional aspect is very important and will only get more important going forward.” Elevar Leafs come in three flavours - fresh mint, mint berry and lavender - and retails at less than £11 for five doses. The discreet, carefully designed packaging could easily be mistaken for a business card, perfect for people who use CBD but don’t necessarily want to shout about it. Based in Poland and with production in Las Vegas and California, SpectrumLeaf is already selling into 16 different European markets including the UK. Launched two-and-a-half years ago and selling a range of products in 1,000 different outlets across the continent, the company is already making a splash in the UK market. So why do people keep coming back for more? Felix said: “With our product, the consumer knows exactly how much they’re taking every time they use it. “We have three flavours and they all taste great - my favourite is the lavender - and they’re very discreet, they fit right into any pocket or bag and it’s easy to share with others too. “There is a lack of CBD products out there which prioritise accuracy and discretion and we believe there’s a clear gap in the market for this. “The packaging is very stylish too, it looks different and fresh.”

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Perceptions are definitely changing around CBD, awareness of the benefits is going up day by day Making sure you are taking an accurate dose is a key concern for CBD customers looking to monitor the effects the product has on them. Each 25 microgram dose is individually packaged in order to allow for a rigorous quality checking process that is carried out before products hit the shelves. This delivery system also ensures users know exactly what they’re getting and are then able to alter the dose as needed. The company recommends between 25 and 50mg per day but ultimately it is the customer who is in control. Felix said: “Accuracy on dosing is very important because most people who use CBD are taking it for a specific purpose and want to be able to work out for themselves what is the right regular dose for them.

“When you look at other products like tinctures and oils, it is quite difficult to make sure you are taking the same amount every time and it’s easy to over or under dose. “You can take more than one tab if necessary and I even know some people cut a tab in half if they want a smaller dose. “This product gives you confidence you are taking the same amount of the product every time and you can easily take it with you if you need to travel or take your dose at an irregular time. “That’s precisely why I use it myself - I think having that control over how much CBD you are consuming is essential to everyone.” The company makes its extensive lab testing data available on its website to further ensure customer confidence in every product. And unlike some CBD products, Elevar Leafs have a long shelf life too. You can keep them in a drawer for as long as a year and they will still be usable. Products paid for securely over the company’s website can be shipped far and wide and usually arrive within one to four business days. Repeat customers can sign up to a loyalty scheme and build up points in order to secure discounts. As the CBD market expands, more and more consumers are coming round to the benefits of CBD. Felix said: “Perceptions are definitely changing around CBD, awareness of the benefits to consumers and usage is going up day by day.” elevarhemp.com

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“ We’re building the tools to empower patients” 24

Hundreds of patients have signed up to the UK’s largest legal medical cannabis identification system, which is giving them a say in the future of the sector.

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The UK’s largest legally prescribed medical cannabis patient validation system, MedCannID launched its pilot scheme in September last year. Since then, over 500 legally prescribed cannabis patients have registered for the scheme, with an almost 100 percent take-up rate, and the pilot scheme ended as a fully operational system for patients was launched earlier this year. The MedCannID card offers simple and effective identification for medical cannabis patients with a unique tamper-proof holographic physical photo ID card and accompanying app. It means patients, who have been legitimately prescribed cannabis medicines by their doctor, no longer have to live in fear of being subjected to police checks. The card is also a vital tool for helping tackle the stigma patients may face and opens up a conversation about medical cannabis, such as in the workplace, out in the community or with landlords or estate agents. “MedCannID provides a voice for legal patients so they no longer have to live in fear, as well as raising awareness of medical cannabis with the relevant authorities,” says founder, Mario Panteli, who has over 20 years experience in cannabis advocacy and patient support services.

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His company, Numeds provided the first medical cannabis prescription to an adult patient in the UK in November 2018. “The response since we launched the pilot scheme has been fantastic and we are starting to see it being really beneficial to the group of patients, but we have only just scratched the surface,” he continues. “There are many more areas to be tackled, such as inequality in the workplace once they have taken the legal route.” As well as the physical confirmation of a patient’s legal status, the MedcannID membership gives patients access to the UK’s largest legally prescribed medical cannabis patients group, with patient related information, shared resources and a patient forum coming soon. To sign up patients need to register, upload and verify a copy of their latest prescription – they may need a referral letter from a current doctor, or may be able to self-refer with their own medical records. The MedCannID app then contains details on the amount and type of cannabis that has been prescribed to the patient, with a direct link to a copy of the prescription. The team behind it believe this data will have a significant influence on the types of new products which are developed for the market and the sector as a whole. “We’re trying to build the tools to empower patients,” Marios continues. “Currently there is nowhere patients can access a list of cannabis-based medicines on the market, but through MedCannID we can compile a list of what products are actually available, to enable patients to be more active in their choices.” Following its success in the UK, MedCannID will shortly be expanding across Europe, with conversations happening in countries such as Poland, Portugal and Greece, where access to cannabis medicines is improving. “I don’t think there’s a scheme like this in Europe, in the way we are tracking access to cannabis and allowing patients to shape the industry,” Marios adds. “Ultimately, the cannabis industry should be patient-led and it’s the patients that drive our mission at MedCannID.” For more information visit www.medcannid.com

MedcannID provides a voice for legal patients so they no longer have to live in fear

Pharmacy backs scheme to stamp-out harassment In March, Lyphe Group, the company behind the UK’s first expert medical cannabis dispensary announced its support for the validation scheme to protect patients from discrimination and harassment. According to Lyphe Group, in a recent survey, 77 percent of patients under its care reported improvements to their quality of life across a spectrum of treatable conditions. However, there are still areas where policies need deeper consideration – specifically at local levels of governance, in councils, police departments and workplaces. It revealed that there have been a number of “avoidable” incidents where “significant errors” were made by the authorities in subjecting patients to discrimination due to their medication. “At Lyphe Group we recognise that medical cannabis patients can sometimes experience unfair treatment or harassment by certain authorities, who are unaware that the medication has been legally prescribed,” the company said in a statement. “One of the main areas of concern for the safety of medical cannabis patients is in the need for educating local police forces. This is in order to adjust areas of misconception and ensure that legal patients aren’t being harassed, or receiving unfair treatment when carrying their medication on them. “There have already been a few completely avoidable incidents in which medical cannabis patients have been inappropriately put under pressure, both in cases of law enforcement overreach and in discrimination in the contexts of employment and housing,” the group continued. “In every case, significant errors were made on the part of respective authorities and this is something the MedCannID is working towards providing clarification on to avoid these circumstances repeating themselves. Dispensary Green will now provide patients with all of the necessary information as soon as it is requested following the dispensing of their medication. The company concluded: “Patients deserve and need to undertake their treatments completely free of concern of harassment. With close cooperation and a constructive approach, we’re sure that the work of MedCannID is definitely a step in the right direction for a workable and sustainable environment for patients and authorities.”

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Medical cannabis comes out on top for chronic pain Medical cannabis improves patients’ quality of life more than any other treatment for chronic pain, says a panel of leading experts. 26

Medical cannabis is among the most effective treatments for people with long-term, problematic neuropathic pain, according to the new paper. Researchers used the latest assessment methods to measure the effectiveness of commonly used drugs at managing pain and improving patients’ quality of life, against side effects. Medical cannabis was found to have the best overall benefit-safety balance for patients with chronic neuropathic pain (CNP). The paper also finds that it is safer overall than other commonly prescribed medications, and that patients taking cannabis-based medications would be less likely to experience many of the side effects associated with more established treatments. One in 11 people in the UK suffer from CNP – including conditions such as nerve damage, sciatica or severe numbing in hands and feet – that substantially impacts on their quality of life. A panel made up of international clinicians, experts and patients, used a multicriteria decision analysis (MCDA) model to compare the safety of cannabis products to those of the nine drugs that are most commonly prescribed for CNP. Cannabis-based products containing a 1:1 ratio of THC and CBD, were found to have a higher benefitsafety profile than commonly used medications such as Amitriptyline and Tramadol.

The patient’s perspective Authors concluded that medical cannabis contributes more to CNP patients’ quality of life and is more favourable in terms of side-effects such as cognitive impairment, dizziness, constipation, affect disorders, overdose toxicity, respiratory depression, withdrawal, and dependency. Patient representative Abby Hughes, who took part in the study, said the patient contribution was “crucial” in highlighting the importance of quality of life compared to reduction in pain. “It is crucial patients were able, for the first time in an MCDA setting, to share their lived-experience in a study identifying the benefit-safety balance of neuropathic pain medications. After all, we are the ones experiencing pain and seeking pain relief for a better quality of life,” said Hughes. “Sharing our experiences equated to the difference in quality of life actually being judged as more clinically important to patients than the difference in pain relief.” She continued: “Interestingly, with the benefits of 12 neuropathic pain medications mapped out, cannabis takes the lead. “The safety was also mapped out, identifying adverse and serious adverse events, from constipation to overdose toxicity. “Cannabis came out as equal or better in safety. Whilst Ibuprofen came out as just as safe, it was also least

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effective, weighted as zero for pain relief and quality of life benefits.” “Controversial” conclusions The report comes just weeks after the International Association for the Study of Pain (IASP) said it could ‘not endorse’ the general use of cannabinoids to treat pain, due to a lack of evidence from ‘high quality research’. The Faculty of Pain Medicine at the Australian and New Zealand College of Anaesthetists (ANZCA) has also advised against prescribing cannabis for patients with chronic, non-cancer pain unless they are enrolled in a clinical trial. A co-author of the CNP and cannabinoids study, Professor Mike Barnes, who has been critical of the IASP statement, said these findings go some way to “refute” its conclusions. “I wish those writing such reports actually spoke to real patients deriving real benefit from cannabinoids for chronic pain,” said Prof Barnes. “They should try to move beyond the narrow pharmaceutical paradigm, understand the plant

and not forget that a doctors’ primary duty is to help their patients. “This study illustrates the efficacy and safety of cannabis and goes some way to refute the conclusions of the report of the IASP which said there was insufficient evidence to prescribe cannabinoids for pain.” His co-author, Dr Anne Katrin Schlag, head of research for Drug Science, the UK-based charity which commissioned the paper, told Cannabis Health the team anticipated that the findings would be “controversial”. “This is another way of broadening the scientific evidence base, rather than solely sticking to randomised control trial (RCT) data,” said Dr Schlag. “What is very important here is that the study is a comparison between different pain medications, including medical cannabis. “While medical cannabis was not found to be the best at reducing pain, when taking quality of life into account and patients being able to function, eat and sleep well, then for the average person, cannabinoids tend to work better than the opioids, which can have serious side effects.”

They should not forget that a doctor’s primary duty is to help their patients

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There are thousands of patient reported outcomes from those who are using cannabis successfully to treat pain 28

Another blow for chronic pain patients Last week, in another blow for chronic pain patients, the National Institute of Health and Care Excellence (NICE) released new guidance advising UK doctors not to prescribe conventional painkillers including opioids and paracetamol for chronic primary pain. Instead it is recommended that patients with these conditions are offered a “range of treatments” to manage their pain, including exercise, CBT and acupuncture. With access to cannabis medicines still restricted in the UK, there has been backlash from patients who fear being left without any viable options. Dr Schlag continued: “For patients experiencing severe chronic pain there should be the option of opioid based pain medications. “Exercise and psychological therapies all have a place and will have lots of benefits for some people, but it is likely there will always be people who need stronger medications.” She added: “At Drug Science we would like to see cannabis added to the current pharmacotherapy in relation to pain. “There are thousands of patient reported outcomes from those who are using cannabis and cannabinoid products successfully to treat pain, including from our own forthcoming Project Twenty21 findings which are due to be published shortly.”

Building a convincing case Project Twenty 21, which launched in November 2019, is Drug Science’s landmark study which aims to widen access to medicinal cannabis, enrolling up to 20,000 patients to build Europe’s largest body of evidence for its safety and efficacy. Drug Science CEO, David Badcock said he hoped this latest paper would encourage regulatory bodies to consider the growing evidence behind medical cannabis and take steps to improve access for patients. “Since being made legal in 2018, many patients suffering from neuropathic pain have told us that cannabis based medicinal products are effective in reducing their pain and its negative impacts on their everyday lives,” he commented. “We are pleased to say that this paper corroborates what many patients have been saying for years, and helps to build a convincing case for more widespread prescription of medical cannabis on the NHS.” Hughes, who is able to access a prescription for medical cannabis through Project Twenty21, echoed these sentiments, adding: “It is hoped NICE will consider reevaluating their guidelines on medical cannabis, recognising that for many patients cannabis provides a better quality of life, provides better pain relief, and has a better safety profile than many other neuropathic pain medications currently prescribed.”

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“You don’t need cannabis to impact your endocannabinoid system” 30

Cannabis Health catches up with psychologist, researcher and Chief Scientific Officer at Endoverse, Simon Weissenberger, to hear more about a complex and often misunderstood area of medicine: the endocannabinoid system.

The endocannabinoid system (ECS) was discovered in the early 1990s by Israeli scientist, Raphael Mechoulam, during his research on the cannabis plant and its effects on the mind and body. Although the system is inexorably linked with the cannabis plant, its function extends far beyond the plant. The ECS is thought to keep our body in a state of balance both physiologically and cognitively, however, most people have never heard of it. A Manchester-based company, Endoverse is seeking to educate medical professionals and the general public about the benefits of the recently established field of ‘endocannabinology’ and demonstrate that there is more to this complex system than its association with cannabis. Existing evidence suggests that endocannabinology could be a useful tool for treating various health conditions, including metabolic syndrome, diabetes, hypertension, anxiety, depression, obesity and other eating disorders. Since launching in 2019, Endoverse has launched a training course that teaches medical professionals about the system and how they can introduce endocannabinology into their practice. The company is now rolling out a number of new services, including a post-Covid programme that aims to use the endocannabinoid system to help people overcome the symptoms of lingering and ‘long’ Covid-19.

The company also has plans in the works for a new arm of the business which will develop solutions for monitoring the status of the endocannabinoid system by measuring the level of endocannbinoids in the body. Cannabis Health: What is the ECS? Simon Weissenberger: There are two main receptors that are known - CB1 and CB2. In the fast-paced, high-stress society that we live in where people are always connected to their phones, we have an overstimulation of the CB1 receptor. This can be associated with anxiety, stress, as well as with things like looking for food or needing a dopamine hit. The point is to have a balance and overall, in our society today, it’s better to keep CB1 under-stimulated rather than overstimulated. Some of the examples of what helps here are things like polyunsaturated fatty acids found in oils like olive oil, hemp seed oil and CBD of course. CB2 is more associated with the immune system which is something that isn’t straightforward or black and white. For instance, it’s not ideal to have an overactive immune system. If your immune system is constantly on the lookout, it’s going to start attacking yourself. This is called autoimmune disorder. CBD, for example, tends to lower immune function and that’s why it’s good for something like multiple sclerosis or other autoimmune disorders

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The ECS is a relatively new discovery in medicine but it’s a crucial component of every day health

people who are studying it are misperceived. Very often [researchers] are working for the cannabis industry and we have no problem with that whatsoever; we’re just trying to make it a little bit more scientific. The big myth that we’re trying to debunk is that you need cannabis in order to impact your endocannabinoid system. The basic fact is that the endocannabinoid system is associated more with fatty acid metabolism in our body than it is with the cannabis plant. CH: Aside from cannabis what other factors can come into play? CH: Why is the ECS so important? SW: The ECS is important because it regulates so many of our physiological functions. The endocannabinoid system is a relatively new discovery in medicine, but it is such a crucial component of everyday health because it regulates things like neural signalling, immune function and a whole variety of things like thermogenesis [maintaining a constant body heat], immunity, homeostatic regulation, hunger, general mood and even pain regulation. It is a system which is in the background, but there are so many bodily functions, physiological functions and mental health issues that are intrinsically connected to it. When we take common sense approaches to health and wellbeing like exercise, getting enough sun and diet, it is all intertwined with the balancing of the endocannabinoid system. CH: What is the connection between cannabis and ECS? The discovery of the ECS and its importance in overall health came about thanks to the cannabis plant, which has been both a blessing and a curse. The legality of the cannabis plant varies around the world and it’s mostly illegal, so it gives the system a bad rep and

SW: Exercise, diet and overall lifestyle all play a significant role. We want to move the perception away from cannabis equalling the endocannabinoid system, get the public to understand how other factors play a part, and then introduce certain health, counselling and dietary interventions to improve people’s wellbeing. CH: What role do fatty acids play in the ECS? SW: The power that fatty acids have on our health is immense and they are essential for the ECS. The ligands (fat) connect to the receptors and are the building blocks of the ECS; the ECS needs that fat to be built. We’re focusing on educating the public about the fact that fats and fatty acids are necessary for human health. There are these misconceptions that low fat diets are good for you. But most people don’t know that there is a biosynthesis effect, so even if you are eating a low-fat diet, your body is producing fat and saturated fat. CH: Your primary focus of research is ADHD. Where does the ECS fit into this area of your work?

There were claims made in the past about omega-3 supplements, and how they help with ADHD. There is now

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CH: What do Endoverse’s training courses for medical professionals entail?

research to confirm that. If you supplement with omega-3 and you take your normal medication, you will have a better outcome than somebody who, for example, is just taking Ritalin and not eating well. Changing diet and integrating exercise are examples of things that people can do to improve their symptoms of ADHD. We now know that these factors are working on the ECS. CH: What is the potential of the ECS moving forward? SW: There is definitely a huge potential and I see it primarily on two fronts. Number one is the research aspect, so understanding in greater depth how this complex system works and how we can improve our health, while being cognisant of the ECS. The second is just as important, which is delivering therapeutic interventions for people that are aware of the ECS. It is a shame that it has been ignored for so long. CH: Why has the ECS flown under people’s radar for the past three decades? SW: One of the main reasons is that its discovery is so recent. In medicine and science, you work on the shoulders of giants. We knew that there were some receptors that connect with cannabis, but then all of a sudden, we’re hearing that these are actually fundamental. It’s like discovering a hidden treasure which you have been trained not to look at. We know more about the ECS now, but it is still not in the paradigm of medicine yet. The thing that is hard to get with the system is that it’s all-encompassing, but it’s also subtle. I’ve spoken to medical doctors who say you need to decondition from standard medical training which is based on very black and white thinking. You need to get away from that and start thinking more holistically and that’s when it starts to make more sense.

SW: Our training focuses on the physiology of the ECS and helps medical professionals understand what is regulated by the ECS the human body, in what way and what the impacts are on the functioning of the system. CH: Who can take the courses and what can participants do with the qualification? SW: People who take our courses should already have some background in either medicine or counselling; something with a scientific background. Through learning about the ECS, you gain the knowledge you need to integrate endocannabinology within your field. For example, a client who is in counselling which integrates the Endoverse model would have blood tests, they would have a diet log, and we would take all that into account within the framework. It could be somebody who has low self-esteem along with some health issues. We would work with their diet and the ECS and maybe introduce CBD as well. CH: What projects do you have coming up? SW: One of the relevant things I will be focusing on is the post COVID or long COVID symptoms, and how they can be managed passively by endocannabinoids like CBD and things like this, but also how these are impacting the ECS, how is it related. Up to 60 percent of people who experienced Covid-19, have some kind of prolonged symptoms that might be manifested as insomnia, anxiety, breathing problems, and so on. These people need some kind of post-Covid care. We are preparing post-Covid online programs, individual and group consultations and we are working on a postCovid retreat. CH: What is Endoverse’s vision? SW: The vision is to educate the public on the ECS, and to provide certain interventions or ways that we can look at balancing the ECS holistically - through fatty acids for diet, exercise and other lifestyle changes.

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Medical cannabis insurance at “fraction of the cost”

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The UK’s society of cannabis clinicians has secured the first master insurance policy for doctors, lowering costs and making it easier for them to prescribe.

The Medical Cannabis Clinicians Society (MCCS) has teamed up with Towergate Insurance on what is thought to be the first master policy for doctors prescribing in the UK. All members can now access coverage at a fraction of the cost of other premiums available to make it more straightforward and affordable to begin prescribing. The development removes another barrier preventing patients from easily accessing unlicensed cannabis medicines in the UK. Doctors working for NHS trusts and health and social care bodies are provided with indemnity insurance through the Clinical Negligence Scheme for Trusts (CNST), or similar. As cannabis medicines are only available privately, doctors working outside of the NHS – often for the first time – need to have their own insurance in order to prescribe. The General Medical Council states that doctors working in private practice in the UK must have “adequate and appropriate insurance or indemnity arrangements in place covering the full scope of your medical practice”. This means that even if doctors are working privately within an NHS or health and social care body premises, they still need to be covered. According to the MCCS, doctors report conflicting information about costs and availability of medical malpractice insurance to cover medical cannabis, with some being quoted over £4,000 per year. This is another barrier which prevents doctors from taking the step to prescribe these medicines for patients in the UK. Professor Mike Barnes, chair of the MCCS explained: “Apart from two specific medications, Sativex and Epidiolex, medical cannabis – along with many other treatments – is at present classed as an unlicensed medicine.

“Doctors prescribing unlicensed products take full clinical responsibility for any consequences of the prescription and might not be covered by professional indemnity insurance. This is something that causes many clinicians concerns and prevents more widespread prescribing.” He added: “Medical cannabis is a safe treatment with often significant benefits and few side effects. Clinicians can be reassured that if they prescribe within the legal parameters, then they are very safe – although they still need insurance cover.” The Medical Malpractice Liability Insurance gives members £1,000,000 of coverage, with premiums calculated based on the number of weekly sessions. Richard Cupit, head of business development at Towergate Insurance Brokers told Cannabis Health that the firm believes in the importance of cannabis as a medicine and hopes that taking this step would help shift perceptions and improve access to treatment. “Access to cannabis-based medicines is vital for patients, but there has previously been a bit of a barrier to entry for prescribers, due to the stigma that still exists around medical cannabis in the eyes of many insurers,” said Cupit. “I’m proud to partner with the MCCS and to be affiliated with the great work they are doing. The minimum premiums can be quite high in the insurance market for medical cannabis, but by working with the society and its members we have been able to offer their members cover at a fraction of the standard costs, which is something that we are really excited to be able to do.” Cupit added: “We hope to help to change attitudes and perceptions of this vital medicine, increasing the number of doctors who see prescribing as a viable option and allow for wider access to treatment in the UK and beyond.” The policy covers medicinal cannabis work only and doctors must complete the MCCS prescriber’s training course within three months of becoming a covered party. Visit www.ukmccs.org for more information

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The parents of three-year-old Charlie Hughes have welcomed new guidelines clarifying that UK clinicians can prescribe medical cannabis.

“Breaking down barriers”:

Parents welcome new NICE guidelines on medical cannabis Matt and Ali Hughes have reached a settlement in their fight with the UK’s health regulator NICE (National Institute for Health and Care Excellence). On Friday 26 March, NICE issued further guidance making it clear that clinicians can prescribe medicinal cannabis in appropriate cases. The Nowrich couple brought a legal challenge against the regulatory body in 2020, after their local NHS Trust indicated that guidance on cannabis-based medicines prevented clinicians from prescribing the medicines to their son, Charlie. Charlie has a rare form of treatment-resistant epilepsy called West syndrome, which saw him suffering up to 120 seizures a day and on a regime of four anti-epileptic

drugs at any one time before they discovered cannabis medicines in May 2019. The couple have seen Charlie’s life transformed by the treatment, with dramatic reductions in his seizures and developmental improvements, but have been unable to access the medicine on the NHS. In November 2019, NICE issued guidance stating that there was insufficient evidence to make a population-wide recommendation for the use of cannabis-based medicines in patients with severe epilepsy. Matt and Ali’s legal challenge set out to clarify this and ensure that doctors are aware that they are not barred from prescribing medicinal cannabis. They wanted clinicians and NHS decision-makers to

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recognise these patients as individuals with treatmentresistant refractory epilepsy and that a population-wide recommendation from NICE is not needed to prescribe on an individual basis. NICE has now agreed to issue further guidance clarifying the guidelines it released in 2019 and Charlie’s judicial review claim has been settled on this basis. The claim was due to be decided in court later this year. Matt and Ali have welcomed the move, which offers hope to dozens of other families denied cannabis medicines on the NHS. “We are very pleased that finally this court case has come to a satisfactory end and we hope this will give paediatric doctors more confidence in prescribing on the NHS, on an individual basis for patients like Charlie who have shown amazing results on medicinal cannabis,” they said in a statement. “This clarification makes it very clear that in individual circumstances clinicians can prescribe if they just weigh up the benefits versus risk.” However, this is just one of several hurdles which are currently preventing Charlie and other patients from accessing their medication on the NHS. The Refractory Epilepsy Specialist Clinical Advisory Service (RESCAS) which is made up of leading neurologists was launched in 2020 to deal with complex epilepsy cases, but so far has only recommended the continuation of cannabis-based medicines for one child. Charlie was referred to RESCAS but refused a prescription for cannabis on the basis that there was no evidence of its efficacy or safety. “There isn’t any one fix, especially in paediatrics, it’s about breaking down all these barriers and trying to understand why this is continuing to be blocked,” Matt told Cannabis Health. “All our focus now is on getting clarity from RESCAS and the British Paediatric Neurology Association (BPNA) as to what it actually takes to get a prescription for a medicine which is helping so many children. “No, we don’t fully understand everything about cannabis at the moment, but if a child has an 80 percent decrease in seizures on cannabis medicines, that’s a really good

We hope this will give paediatric doctors more confidence in prescribing on the NHS, on an individual basis for patients like Charlie, who have shown amazing results on medical cannabis

outcome in relation to the small risks of THC.” He added: “I’d like to see neurologists standing up for the child and actually looking at the evidence that’s there in front of them. “It’s going to be a long process but this is a very good step moving forward.” The couple thanked their counsel Tom Cross and Katherine Taunton, and solicitors from Irwin Mitchell and Herbert Smith Freehills, who have spent hours supporting the case. Hannah Deacon, mother of Alfie Dingley and director of the Medical Cannabis Clinicians Society, was also instrumental in bringing the case. NICE’s clarified guidance states as follows (among other things): “3.2 The fact that NICE made no such population-wide recommendation should not…be interpreted by healthcare professionals as meaning that they are prevented from considering the use of unlicensed cannabis-based medicinal products where that is clinically appropriate in an individual case. Patients in this population can be prescribed cannabis based medical products if the healthcare professional considers that it would be appropriate on a balance of benefit and risk and in consultation with the patient, and their families and carers… 3.3 There is no recommendation against the use of cannabis based medical products.”

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No evidence of liver toxicity in adults using CBD 38

A first-of-its-kind study has found no evidence of liver toxicity in more than 800 adults consuming CBD.

Following seven months of clinical investigation, researchers have reported no preliminary evidence of liver disease in the 839 adults taking CBD as part of the trial. Validcare, which conducts patient-centered clinical trials, announced that its team of investigators met with members of the US Food and Drug Administration’s Cannabis Product Council (formerly known as the Cannabis Work Group) to share initial findings from the industry sponsored, human safety study. Preliminary findings show no evidence of liver disease in the participants and no increase in the prevalence of elevated liver function tests when compared to a population with a similar incidence of medical conditions. The study was commissioned in response to the FDA’s requests for science-based data, so it can confidently determine the appropriate regulatory path for hemp derived CBD products. “Our primary endpoint in this study is to observe potential liver effects in adults ingesting oral forms of hemp derived CBD for a minimum of 60 days,” explained coinvestigator Jeff Lombardo PharmD, BCOP. “What we observed to date is no clinical evidence of liver disease in any participants. We observed slight, clinically insignificant elevations of liver function tests in less than 10 percent of consumers irrespective of age, product

composition and form and the amount consumed. “Three of the 839 participants had three times the normal levels of the liver enzyme ALT. These three consumers are taking prescription medications that are known to elevate liver enzymes, and we are investigating whether prescribed medications or other factors contribute to these outliers.” Investigators were surprised to find that almost 70 percent of study participants reported having a medical condition and taking medications, without an increase in adverse events. Studies of similar populations demonstrate an 11 percent elevation in liver function tests, while this research demonstrated less or equal to nine percent. “This unexpected, positive finding makes the data even more compelling and provides significant data to consider secondary safety measurements in the general population,” added Keith Aqua, MD, co-principal investigator. “We are encouraged by these findings and hopeful this study provides the FDA with sufficient science-based data to determine and take action on a safe regulatory path forward. We will continue to analyse these real world data and are adding a second cohort to this study to increase statistical certainty for liver safety and secondary measures across diverse populations and consumers with

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various medical conditions.” Principal investigators met with the FDA on 15 March and reviewed preliminary liver safety study results in the form of an abstract. The parties also discussed establishing a direct communication feed to FDA so it can receive raw, data for its analysis. Twelve major CBD companies led the industry in this initial study; Asterra Labs, Care by Design, CBDistillery, CBD American Shaman, Charlotte’s Web, Columbia Care, Global Widget, HempFusion, Infinite CBD, Kannaway, Medterra CBD and SunMed CBD. Each brand provided funding, product, certificates of authenticity, and assisted with recruitment of adult US based consumers. Consumers completed the study between August 2020 and February 2021. Use of Validcare’s decentralised clinical research platform and partnership with national laboratories enabled participants and principal investigators to successfully complete this first cohort, despite the pandemic, and compile and deliver results to brands and FDA within six weeks.

Patrick McCarthy, CEO of Validcare, commented: “Congressional leadership asked Validcare almost 18 months ago to engage industry help collect safety data for the FDA. “We understand the significance, importance and immediate need for CBD safety research for the FDA, industry and the US consumer. “This first of its kind, industry led, multi-branded study required trust, collaboration, operational excellence, innovation, and resilience. It demonstrates the incredible potential for decentralized clinical research to increase participant access and accelerate results – even during the most challenging times” McCarthy added: “We are excited for our principal investigators to continue, expand and report out on this foundational work in the next few months. Once completed, safety results of this study will be shared with participating brands and FDA. The investigators also plan to publish in a peer reviewed journal.”

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Spelling out the science behind CBD 40

The duo behind CBD brand NOT THC have found a way to combine a background in science with a desire to do good, in a way that makes perfect sense. You have a background in science, you want to start a business but you don't really know where to direct your efforts - what do you do? CBD, naturally. That's what happened to Ngoni Madinga and Iza Mavuru, the duo behind CBD brand NOT THC, a company based in the North of England offering a range of products. Set up in May 2020, the company already has a portfolio of offerings designed to make CBD a seamless part of everyday life. The company was created as a business venture that put the founder's experience of working in laboratories to good use. Ngoni told Cannabis Health: "We knew we wanted to start a business that incorporated our backgrounds in science with our sincere ambitions to try and help other people. "When we set out, we didn't know what that would be, it was just a concept we had. "Then we came across CBD and did some research and learned more about it. "We both thought this is something that is definitely helpful and as scientists we are able to understand how it functions and then explain that to people. It seemed like an appropriate fit for our vision."

At the centre of the company is the idea that you need to be able to explain the science behind the products to consumers who might be wary about trying something new. Iza said: "We come from industries and backgrounds that deal with data analysis and explaining things through science in a way that makes sense to people. "That has given us an advantage to be able to connect with people" She added: "CBD can very easily look like a sham or a scam product when you are new to it. "It's very important to have people in the industry who understand how it works at a scientific level and people with personal stories that can share their knowledge." The pair met six years ago and formed a close personal relationship which turned into a business relationship after working together in different labs on and off over the years. Both Ngoni and Iza are originally from Zimbabwe but have spent much of their lives in the north of England where the company is headquartered. Their flagship product is a blueberry kush oil which is based on the well known cannabis strain but is lab tested to ensure it contains

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no THC, the prohibited compound in the plant that produces the 'high'. But for customers looking for a more seamless way of consuming CBD, NOT THC also offers teas and creams that can be substituted into your daily routine. Speaking about their signature Lemon Che-tea and Khulula Cream, Iza said: "We wanted to give a great offering to our customers. Our goal is for CBD to be used on a daily basis to improve overall health and wellbeing. "Something like our tea is accessible - it's a gorgeous, nice tasting tea but you're getting a 35mg dose of CBD from a tea bag. "You don't need to think about too much, but you're still getting the benefits. "And the cream is amazing - we recommend it as a hand and face lotion but to be honest it can be applied anywhere on the body. "It's incredible in terms of the effects it has on the skin, it's very enriching and has a unique, lovely smell." NOT THC is currently running a sale until June 21, with plenty to buy one, get one half price and buy two, get one free offer. They also offer a 15 percent discount on the first Saturday of every month.

0113 328 1118 • info@notthc.life www.not-thc.com

It’s important to have people in the industry who understand how it works at a scientific level

REPORT

Is cannabis the key to tackling the opioid crisis? Increasing evidence is pointing towards the fact that access to medical cannabis is leading to a decline in opioid-use, Joe Roberts reports.

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While the world battles the Covid-19 pandemic, The US and Canada are continuing to fight an epidemic of their own; the ‘Opioid Crisis’. Declared a public health emergency in 2017 by the US Department of Health and Human Services, an estimated 10.3 million people misused prescription opioids in 2018. The opioid crisis is thought to date back to the late 1990s when pharmaceutical companies claimed patients would not become addicted to opioid pain relief medications. Prescription rates soared and, in turn, an increasing number of Americans became addicted to painkillers such as OxyContin. According to the US National Centre for Health Statistics, the death rate from drug overdose more than tripled between 1999 and 2016. The UK has shown signs of following North America’s footsteps as it faces a growing issue of opioid dependency. The latest figures show that the number of people dying from opioid-related drug misuse has reached a record high in England and Wales, and last year, the UK government strengthened opioid addiction warnings. With opioid deaths rising, medical cannabis has become a beacon of hope as a possible alternative for opioid-based drugs.Recent research, for example, found that half of medical cannabis patients stop using opioids for pain management after just 12 months. A team of Canadian researchers assessed self-reported opioid consumption patterns over time in a cohort of medical cannabis patients who suffered from pain-related issues. Researchers reported that many subjects tapered their use of opioids following medical cannabis initiation. The primary outcomes studied were pain intensity and pain-related interference scores assessed at three month intervals for a period of 12 months. The team also assessed anxiety, depression, quality of life, general health symptoms, neuropathic pain, self-reported opioid consumption, and adverse events. “The proportion of individuals who reported using opioids decreased by half, over a period of twelve months,” they determined. In addition, the participants’ “pain intensity and painrelated interference” scores were reduced and quality of life and general health improved. The study came only weeks after a separate Canadian study reported that patients prescribed opioids were able to reduce their opioid dosage by a staggering 78 percent following the consumption of medical cannabis. Published in the journal of the American Academy of Pain Medicine, the ‘Tilray Observational Patient Study’ analysed 1,145 medical cannabis patients over a six-month period. Patients were monitored from 21 medical clinics across Canada, which is second to America in its opioid consumption. Conservative MP and member of Conservative Drug Policy

A 78 percent reduction in opiates within six months is extraordinary

Reform Group (CDPRG), Crispin Blunt, told Cannabis Health: “Evidence is very strong on the benefits of substituting opiates for cannabis-based medicines. A 78 percent reduction in opiates within six months is extraordinary. “Increasing numbers of people worldwide are experiencing the potential benefits of cannabis-based treatment as an opiate alternative that are evidenced so profoundly in this study.” “As clinicians continue to demonstrate cannabis’ medicinal potential in empirical frameworks, the case for changing public policy to enable widespread medical access to it becomes overwhelming.” The scientists behind the study say that the observed reductions in opioid use suggests that cannabis has the potential to play a “harm reduction role” in the opioid crisis. The excessive prescribing of opioids for treating pain in the US has led to a staggering number of deaths linked to overdose. In just one year (June 2019 to June 2020), the US reported just over 48,000 deaths attributed to synthetic opioid overdose. In parts of the US, this figure is falling and research suggests that this could be in part due to the opening of legal cannabis dispensaries across the country. Some studies have suggested that increased access to cannabis stores, which are legally authorised to sell medical and recreational cannabis, may help to reduce opioid related deaths, however the evidence so far is mixed. To explore this further, one group of researchers examined relationships between medical and recreational cannabis stores and opioid related deaths from 2014 to 2018. Their findings were based on data for 812 counties within the 23 US states that allowed legal cannabis dispensaries to operate by the end of 2017. Information on state level cannabis legislation was combined with county level data on licensed dispensaries and opioid related mortality rates. After controlling for population characteristics and other potentially influential factors, the researchers found that counties with a higher number of active cannabis

REPORT

dispensaries were associated with reduced opioid related mortality rates. According to this estimate, an increase from one to two dispensaries in a county was associated with an estimated 17 percent reduction in all opioid related mortality rates. An increase from two to three dispensaries was associated with a further 8.5 percent reduction. This study was the first to examine the association between active cannabis dispensary operations and opioid related mortality rates at the more fine grained county level. However, the results are observational, meaning that they can’t establish the cause. The researchers stress that while cannabis is generally less addictive than opioids, it still carries potential harms and public safety risks should not be ignored. They did, however, say their findings suggest “a potential association between increased prevalence of medical and recreational cannabis dispensaries and reduced opioid related mortality rates.” In a linked editorial, researchers argued that cannabis liberalisation “cannot be regarded as a remedy to the opioid crisis until a robust evidence base is available.” Although some may interpret these findings as evidence supporting cannabis liberalisation to address the opioid crisis, they point out that “such conclusions are currently premature without evidence of causality.” Despite this growing body of research demonstrating the potential of cannabis-based medicine, there remains a lack of clinical data to prove its efficacy and provide clinicians with peace of mind when prescribing the drug. In an effort to close the knowledge gap, one group of researchers published a paper in the international Journal of Clinical Practice offering clinician’s practical advice for prescribing cannabis for chronic pain.

Cannabis may be part of the toolbox that we can use to help shift the course of this devastating trajectory.

REPORT

Supported by one of the world’s leading cannabis companies, Canopy Growth Corporation, and its medical cannabis division, Spectrum Therapeutics, the consensus paper gathered recommendations from twenty-three clinicians from around the world who had experience using cannabis in their practice. The paper sets out guidance based on these recommendations, explaining when and how to safely prescribe cannabinoids when opioids are a being used for chronic pain. The paper also includes suggestions on how to decrease patients’ dosage of opioids when on a course of cannabis-based medication. “[The paper] was very much about distilling physicians’ clinical experience into a pragmatic consensus document that clinicians can have in their back pockets,” Dr Mark Ware, chief medical officer at Canopy Growth, told Cannabis Health. “If they choose to prescribe cannabis-based medicines, they will have some kind of recipe to follow. “The general takeaway was that this is an approach to take for patients who are on opioids with chronic pain but aren’t getting the kinds of outcomes that you would want to see. “The consensus was to start with low doses of CBDpredominant cannabinoid therapies to begin with, and then potentially introducing the THC-containing compounds.” As a pain physician himself, Dr Ware said he would feel confident turning to the consensus if he chose to treat one of his patients with cannabis-based medical products. Although clinical research remains incomplete, millions of people across the world are self-medicating with cannabis to ease their chronic pain. “One thing we know is that these cannabinoid compounds, from a scientific background, are remarkable drugs in the way that they act in the human body,” Dr. Ware said. “We know that they can co-interact with opioids to improve pain control in animal models, and we know from largescale follow up studies that people who use cannabis in their self-management of pain are able to reduce their use of opioids. Despite demonstrating potential for lessening patients’ dependency on opioids, Dr. Ware stressed that cannabis alone will not solve the opioid crisis. “Different ways of prescribing and approaching chronic pain have to come into play,” he said. “Cannabis may be part of that toolbox of things that we can use to help shift the course of this very devastating trajectory. But it wouldn’t be right to say that this is the solve – it may just be one part of it.” For decades, cannabis has been branded as a ‘gateway drug’; a drug that leads individuals, especially younger users, to harder substances like cocaine, heroin and methamphetamine.

However, some research is disputing this claim. Since the introduction of laws in Colorado and Washington legalising the sale of adult-use cannabis, research has found that there has been no increase in the number of teens and young adults seeking treatment for substance abuse of either opioids, cocaine, or methamphetamine. Researchers from Temple University in Philadelphia and the University of Tennessee in Knoxville compared pre- and post-legalisation trajectories of substance abuse treatment admissions rates in Colorado and Washington to a set of other US states that did not legalise recreational cannabis use. Specifically, investigators assessed treatment admissions for opioids, cocaine, and methamphetamine among those between 12 and 24 years of age. According to the data published in the Journal of Substance Abuse Treatment, authors did not identify any rise in drug treatment admissions in either state following legalisation. Additionally, the treatment trajectories in those states did not significantly differ from comparable states that did not liberalise their cannabis laws. Commenting on the study’s findings in a press release, Norml’s deputy director Paul Armentano said: “This data further undermines long standing claims that marijuana acts as any sort of a ‘gateway’ to the abuse of other controlled substances – an allegation that has, historically, largely guided prohibitionist-based marijuana policies in the United States despite a lack of hard evidence.”

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Inside Project Twenty21 Drug Science’s 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. Cannabis Health speaks to a patient and prescriber about their experience on the project so far.

Project Twenty21 was 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. Drug Science aims to build Europe’s largest body of data on the safety and efficacy of cannabis and help more people gain access to the medicine legally.

Cannabis Health: What got you interested in medical cannabis? Dr Rebecca Moore: 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.

The prescriber

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: 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.

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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.

The patient Matthew Taylor lives with a number of debilitating conditions including degenerative disc disease, spinal stenosis and osteoarthritis. He has struggled for years with both chronic pain and mobility issues which, up until now, he has managed through traditional pain medication. CH: What medication were you using before you were prescribed cannabis? Matthew Taylor: Before medical cannabis, I was on a combination of opiates, opioids, muscle relaxants and general painkillers. They made me feel very distant and detached. I wasn’t able to communicate with people very well at all and I used to feel very nauseous most of the time.

I was able to get away from that with medical cannabis. The fentanyl I was previously on was nowhere near as effective as a painkiller as medical cannabis has been. CH: How did you find out about Project Twenty21? MT: I found out about it through another medical cannabis advocate, who I was introduced to through my local MP. CH: How have you benefited from medical cannabis? MT: Medical cannabis has certainly changed my life for the better. I’ve been able to come off medications that severely impacted how I was able to participate in daily activities. Even things as simple as communicating with my kids and my wife. We play board games, I help them with their homework a lot more; my head is so much cleaner and pain is reduced incredibly. I would say 50 percent of my pain has gone from my first two inhales of medical cannabis. I wouldn't be able to sit in this room on this particular chair without medical cannabis. There's only one chair that I could sit in for more than 10 minutes and it cost 400 pounds. The difference in my life is remarkable. I feel like me again, as if I’ve come back from a long sleep. I wasn't me for a good 10 years, to the point where I was using SSRI medications for depression, which I am currently coming off at the moment. CH: What do you think needs to change for patients? MT: Medical cannabis needs to become available for more patients, as it can help with a range of medical conditions, as I'm sure will become apparent from the results of Project 2021 when they come out. I think many people just simply don't understand medical cannabis as a medicine. They are afraid of stories that they’ve heard over the years. Misinformation claiming that it can make people psychotic, it can make people become violent or dangerous. And that is simply not the case. There's a doctor there alongside you during the project to make sure that you can take the medicine appropriately and it is helping your condition.They're extremely helpful for that. I hope that many other patients do go ahead and sign up to come on board the project because it will help with regards to fully accepting medical cannabis in the UK. To find out how you can join Project Twenty21 as either a prescriber or a patient, visit www.drugscience.org.uk/projecttwenty21

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“Medical cannabis was my daughter’s last hope”

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Cannabis medicine was Tannine’s last hope when she boarded a plane to the Netherlands with her severely epileptic daughter. But now Brexit regulations threaten to take that away, she tells Sarah Sinclair. Indie-Rose, now six, had her first seizure in her high chair at four months old. “I’d never seen anything like it in my life. I was petrified annd I didn’t know what to do,” says Indie’s mum Tannine Montgomery. Doctors reassured Tannine it was just a febrile convulsion, a fit that can happen in babies as a result of a fever or spike in temperature. Although she was shaken by it, she wasn’t overly concerned. “I was really scared about what I had seen, but we took

her home and I thought to myself she’s going to be fine, it’s just one of those things,” she says. “But Indie didn’t stop seizing. The seizures progressed quickly and she was soon having a lot of them. We were constantly calling an ambulance.” Even when doctors told Tannine that they thought her daughter had epilepsy, she was still hopeful that she would lead a relatively normal life. “I knew nothing about epilepsy at the time, I’d never seen anyone have an epileptic seizure, but I thought we would get some medicine and Indie would be able to live a normal life. I was quite hopeful that’s what would happen,” she admits. Indie was prescribed various antiepileptic drugs, none of

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We could see straight away how this was helping her interact and function so much better

which managed to keep her seizures under control, and underwent a number of tests, from MRI scans to lumbar punctures while still just a few months old. Her doctors eventually discovered a gene mutation related to Dravet syndrome, a rare but severe form of epilepsy, which along with uncontrollable seizures causes a number issues such as cognitive decline, hypermobility and problems with movement and walking. By the age of two Indie’s development had halted and she lost her ability to talk. But it was the contrast seizures which were leaving her most at risk. “By the time Indie was three, we were eight antiepileptic drugs down and still nothing stopped her seizures. We were still calling ambulances constantly and I just couldn’t see that for her for the rest of her life,” says Tannine. For the next year Tannine dedicated any spare time that she could to researching medical cannabis. “I’d heard it could help but if I was going to give it to my daughter I wanted to make sure I was giving her something safe and that I was being legal – I didn’t want to risk my daughter being taken off me,” she says. Tannine eventually met the founders of a UK CBD company, who showed her around the facility, explained the extraction process and gave her some oil to try with Indie. “For three weeks it sat in my cupboard, because I was too scared to use it,” she remembers. “Finally, Indie had this awful night, with so many seizures. I opened the cupboard to get her normal medication and saw the CBD oil. I thought, ‘I’ve got nothing to lose’.” Ten days later Indie ran down the garden for the first time. “It was amazing, we’d never seen her run,” says Tannine. “Indie’s dad and I just looked at each other and realised this was actually helping her. “From that point on we started trying to get her a

prescription, so we had guidance from doctors and could make sure we were giving her a therapeutic dose.” With cannabis still illegal in the UK, even for medical purposes, Tannine contacted the Erasmus Hospital in Rotterdam, where a paediatrician agreed to prescribe Indie the whole plant cannabis oil Bedrolite. With Indie’s condition at its worst Tannine left her 11-month-old son with his grandmother and travelled to the Netherlands in a bid to save her daughter. “She was having seizures on the aeroplane. I was petrified, but I felt like it was my last hope,” she says. “As much as people could say it was unsafe to take her, Indie had seizures every day. I would never have got her out of the country and I needed to get access to this treatment.” The next day Tannine took Indie to her appointment with the pediatric neurologist and collected her prescription from a local pharmacy. “It was just a regular pharmacy selling paracetamol and other medicines, it was amazing that we could just go to and collect it,” she adds. After one day on the medicine Indie slept through the night. After four days she had had no seizures at all. When Tannine’s partner arrived to join them with their son, Indie played with her little brother for the first time. “I remember him standing at the doorway of this Airbnb and she ran up to him to tickle him. Up until then it was like she hadn’t even known he existed,” says Tannine. “We could see straight away how this was helping her interact and function so much better.” The family put their lives on hold and spent three months in the Netherlands, unable to return to the UK with Indie’s medicine. Tannine describes the experience as like “living in lockdown”. “We were there for just over three months, but it felt like forever,” she says. “It was traumatic, it certainly wasn’t a holiday. We didn’t have money to spend on sightseeing, it was all for Indie’s medicine and the whole time I was fundraising to be able to afford to keep her on it, because it’s not cheap.” Eventually Indie was granted a licence to import Bedrolite to the UK through a private prescription and in November 2018 the law changed to legalise medical cannabis. But Tannine continued to campaign for NHS access, with no option but to rely on donations for Indie, having spent over £30,000 on her prescription fees to date. It was this that drove her to launch Sweet Pink CBD last year to help fund Indie’s medicine, as well as supporting others in similar circumstances. “Unfortunately, when a bottle of Bedrolite oil is £160 for 10ml and your child’s using two of them a week, that’s not attainable for anyone who’s just holding down a normal job,” she says. “I didn’t feel like I was getting anywhere with the government and I didn’t want to have to rely on fundraising forever.”

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Tannine saved up out of her benefits and began making her own products, using a 10 percent cannabis oil, similar to Bedrolite, but with lower levels of THC and legal in the UK. “I had a lot of good feedback and that’s when I decided that this is something I could do to provide Indie with what she needs and help people at the same time. I wanted to create an authentic company built on love for my child and my desire to help other people who have to suffer the way she does,” she says. “This isn’t prescription medication, but each person is so individual in what works for them when it comes to cannabis, it’s always worth trying something. When I get a text message from a mother who says her daughter stood up for the first time, it makes my day. “There isn’t anything in this world that can make me feel better than improving a child’s life.” Indie hasn’t been hospitalised for three years since she began taking the Bedrolite, she hasn’t needed any rescue medication or pharmaceuticals and last year her attendance in school was 96 percent. However, Brexit left Indie and dozens of other patients at risk of losing access to the life-saving medication. The family were given just two weeks notice after the Department of Health and Social Care (DHSC) sent a

letter to importers, clinics and patient groups, stating that prescriptions issued in the UK ‘can no longer be lawfully dispensed in an EU Member State’ from 1 January, 2021. Those prescribed Bedrocan oils through the Transvaal pharmacy based in the Netherlands, were advised to find “alternatives”. But as many experts have warned, switching these children’s medications could be lifethreatening. Plant and cannabis expert Dr Callie Seaman told Cannabis Health that with over 565 different secondary metabolites in cannabis plants, each batch is subtly different, let alone each product or supplier. And consistency is vital in the treatment of severe epilepsy. “For patients taking medical cannabis for palliative care and other diseases, a switch in oil is not the end of the world, but what’s needed with epilepsy is consistency,” she explained. “Any neurologist will tell you that when you find something which works, you have to stick with it. As soon as you start changing things that’s when the issues arise, and any seizure comes with the risk of death.” Dutch authorities have agreed to continue to supply Bedrocan oils to UK patients until July 2021, while a more permenant, “long-term” soltution is reached. Indie still lives with disabilities as a result of her condition, but the seizures she has are much less severe. The fact her medication could be at risk again is an added worry for Tannine, who says if a permenant solution surrounding the import of cannabis medicines from the Netherlands isn’t found, her condition could worsen. “She’s doing so much better than she was,” she adds. “I couldn’t dream of taking it away from her now.”

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Why women in pain are turning to cannabis medicines 52

The current medical system sees women’s pain routinely dismissed, while complex conditions are often left undiagnosed and untreated for years. Now, many are looking for another option, writes Sarah Sinclair.

“From when I started my period aged 11, until my early 20s, was a decade where I honestly didn’t feel listened to at all,” says Laura. “My doctors would blame it on puberty and hormones and repeatedly prescribe me the contraceptive pill. But even on the pill I would soak through the heaviest Tampax and night time sanitary towel within an hour.” She adds: “I was definitely made to feel that I was exaggerating my pain and being dramatic about it.” Laura, 29, was dismissed by her doctors for years as just having “bad periods”. By the time she was in her late teens she was regularly missing school. Once at university, she would find herself bed bound in excruciating pain everytime she got her period. Then sex became painful too. “About six years ago it got too much and I went back to the doctor,” she recalls. “As I started explaining he immediately said, ‘oh well women who are promiscuous often have these issues’. “I hadn’t told him my sexual history at all, to be automatically labelled as being promiscuous when I wasn’t even sexually active due to the pain was a real slap in the face.

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“It was so unprofessional. Why would he think it was okay to speak to me like that?” After a full sexual health check and a transvaginal ultrasound Laura was later told she had a thickening of the uterus. It wasn’t until a few months later at a routine pill check-up that the nurse asked if she was on the pill for her endometriosis. “I had no idea what she was talking about,” she says. “She showed me on the screen the doctor’s notes that I had suspected endometriosis. They had known for six months and no one had thought to tell me.” The body is a battleground Endometriosis is the second most common gynecological condition in the UK, affecting around one in 10 women – although frequent misdiagnosis and a lack of understanding in the medical profession mean this figure is likely to be higher. Although there is no known cause, the condition is characterised by tissue similar to the lining of the womb that starts to grow in other places, such as the ovaries and fallopian tubes.

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I was definitely made to feel that I was exaggerating my pain

It is commonly associated with pelvic or abdominal pain, but can also cause significant pain elsewhere in the body and lead to other symptoms, including painful sex, reduced fertility and fatigue. These can be completely debilitating and significantly impact a woman’s quality of life. Laura’s case is far from unique. On average it takes seven and a half years from the onset of symptoms for a woman to receive a diagnosis of endometriosis. This is exacerbated by the fact it can only be diagnosed for definite by a laparoscopy, a surgery used to examine the organs inside the abdomen. When Laura was finally referred to a gynecologist and underwent the surgery, she was diagnosed with stage four - the most severe form of endometriosis - on her uterus, ovaries, bladder and pouch of Douglas. “I’ve been told that the pain will never go away because of where the lesions were,” says Laura, who is now a reproductive health advocate and blogger through The Endo Monologues, a satirical diary about her experience, from the point of view of her uterus. “Once I was referred to my gynaecologist she was amazing, she took me seriously. She said I should have been referred months, if not years ago.” Like many women living with complex, undiagnosed health conditions, Laura was made to believe that there was something wrong with her, that it was “just the way her body was”.

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“My mum, auntie and grandmother all had heavy periods, and from a young age my mum had always told me I would probably start them young,” she says. “I think subconsciously I’d been mentally prepared for that, and the fact that it was blamed on my hormones, I was made to believe that was just how it was going to be. It was just my body.” There is a long history of women’s pain being treated differently to that of men. Countless women feel they have been dismissed, not taken seriously and ‘medically gaslighted’ - a term which has recently been used to refer to healthcare professionals downplaying symptoms with non-medical or emotional reasons - into believing their pain isn’t real. It’s all in your head There are biological differences in how women and men experience pain. Women supposedly experience more severe and frequent levels of pain, for a longer duration than men and are more likely to report migraines, musculoskeletal pain, and pain from osteoarthritis, rheumatoid arthritis, and fibromyalgia. Despite this women are taken less seriously and are more likely to have their pain discounted as “emotional” or “psychogenic” and, therefore, “not real. Women often have to make more visits to the doctor than men in order to be referred to a specialist and a 2014 Swedish study found that once in A&E women waited longer to be seen and were less likely to be classed as urgent. If women aren’t taken seriously for conditions which affect both sexes, there is little hope for those with female-specific conditions such as endometriosis, which aren’t widely studied in medical school unless specialising in gynecology. The current model of medicine has largely ignored the complexity of the female body and many women are still unaware of female health conditions such as pelvic inflammatory syndrome (PIS) or vulvodynia, which often go undiagnosed and untreated for years. In her book, Sex Matters, Dr Alyson McGregor points out that out “male-centric medical system” doesn’t allow for the subtlety and complexity of female-specific health issues. “We have blanket terms for women’s symptoms (like PMS) but we don’t have a system for delving into those issues in a way that can consistently result in accurate diagnoses,” writes McGregor. A report published in the Guardian in April, revealed that women were twice as likely to be prescribed strong opioid medications such as codeine and tramadol, with female sources telling the newspaper they felt “fobbed off” by painkillers while doctors failed to investigate the underlying causes.

Last year a Government inquiry uncovered that serious medical conditions were commonly dismissed as “women’s problems”, contributing to a string of healthcare scandals over several decades. Dr Sally Ghazaleh, female pain consultant at Integro Medical Clinics, and pain management consultant at Whittington Hospital, and the National Hospital of Neurology and Neurosurgery in London, believes a lack of knowledge among GPs, plus a stigma that still exists around women’s health, is to blame. “A lack of knowledge at a primary care setting and perhaps women being met with scepticism, a lack of comprehension and feeling rejected, ignored, or blamed for their condition and experiencing a stigma towards women’s health, all contribute to conditions such as PIS and vulvodynia being undiagnosed and untreated for many years,” she says. “At the same time doctors want to ensure there is no underlying cause that could be the source of the pain. Therefore patients will be referred to a specialist and it can take a very long time to be seen, time, which can have a huge psychosocial impact on women’s health.” The UK government is now launching a review in an attempt to better understand women’s experiences of the modern healthcare system, including how pain is treated, which it says will create the first-ever government-led Women’s Health Strategy.

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Seeking validation In the meantime, many women are looking for alternative options. Laura has used CBD to manage her symptoms for around two years and now has a private prescription for medical cannabis subsidised through Drug Science’s Project Twenty21. Cannabis allows her to manage her pain without the debilitating side effects of opioids. “I vividly remember after my first surgery, they pumped so much morphine into me, it made me hallucinate,” she says. “I had no idea a prescription would even be an option for me until someone suggested it. It would have been so much easier for me to go to the doctor and say I need some opioid based medication, than it was for me to get medicinal cannabis, but I don’t particularly like taking pharmaceuticals. I’d much rather take cannabis daily than morphine.” Speaking to Cannabis Health earlier this year, Dr Rebecca Moore,a psychiatrist who specialises in trauma, anxiety and mood disorders, particularly related to women’s health, said she believes that the gender bias in the medical system drives women to look for another option. “A lot of people come to us with stories of not being heard and of being dismissed, particularly from young women presenting with pain and perhaps unusual symptoms, with some form of mood component,” said Moore, who has supported hundreds of patients to access cannabis medicines since leaving her role in the NHS in 2018. “There’s definitely something about the way medicine is gendered, that does bring people to look for another option. “A lot of women have been told they’re depressed when clearly they are not, or they have been told that their pain can’t exist… I think it drives them to see cannabis as a route where they might be validated.”

Thirty-six-year-old women’s rights advocate, Freya Papworth, was diagnosed with fibromyalgia only two years ago despite being in pain since the age of 13. As a teenager doctors blamed her pain on the fact she carried her rucksack on one shoulder, then said it was the effects of a car accident she was involved in aged 21. At 23, Freya broke her back when she was thrown from a horse, but medics promised she would bounce back “even stronger” despite her medical history. She spent the next decade believing she was “going mad”, suffering from severe pain, major fatigue and constant sickness, before finally getting a diagnosis through a private clinic. “I’ve been sent to a psychologist multiple times, rather than a specialist, because I must be crazy rather than have doctors take my pain seriously,” says Freya, who is currently self-medicating with cannabis while she explores the possibility of getting a prescription. “You can see why more women are turning to alternative therapies, we are routinely ignored and disbelieved. “Medicine is routinely not tested on women and we are often let down by the healthcare system, so we look for other ways. “Then we are ridiculed for trying mindfulness or essential oils, when we’re just in pain and want find something that works.” Increasing numbers of women are finding cannabis medicines helpful in managing their health conditions. Since the legalisation of medical cannabis in 2018, many patients have discovered that the rebalancing of their endocannabinoid system can be effective in the management of conditions such as endometriosis, bladder and nerve pain, gynaecological pain and PMS, as well as mental health conditions such as anxiety, insomnia and depression. “The endocannabinoid system plays a major role in many bodily functions, including sleep, stress, emotions, pain and immune responses,” explains Dr Ghazaleh. “There are a multitude of cannabis receptors and endocannabinoids in the uterus and female reproductive system. That is why cannabis affects men and women differently and women appear to be much more sensitive than men to many aspects of phytocannabinoid action.” Endometriosis has been linked to endocannabinoid deficiency, with a 2017 study finding that women with the condition have fewer cannabinoid receptors in their pelvis. Their body isn’t equipped with the tools that would normally prevent the growth of aberrant cells and destroy them. Studies have shown that when certain cannabinoid receptors are activated (either by the body’s endocannabinoids or THC found in cannabis) this could prevent cells from multiplying, while cannabinoids such as CBD may stop the cells from migrating.

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On top of this cannabis is an effective painkiller, with its anti-inflammatory properties and ability to desensitize pain receptors around the body. Dr Ghazaleh adds: “In view of the significance of the endocannabinoid system in female reproductive systems, medication that may interfere with cannabinoid action are now considered alternative options for women’s health.”

for a prescription,” she says. “Women are made to jump through hoops to get a diagnosis. Whether it’s a gynaecological issue or not, we are not as high on the radar as men are and the gender pain gap is a real issue. “I think it’s important for women to know that cannabisbased therapies are available and that they might be more suitable for them.”

Beyond the stigma But many women are still reluctant to be open about their use of cannabis medicines. Freya says: “It’s interesting the amount of women who are curious about trying it, just normal suburban women. “I don’t think many of us are being honest with our GP’s we’re worried about the stigma of being seen as a drug addict.” Apart from her followers online - to whom she remains anonymous - only Laura’s mum and partner know that she has a medical cannabis prescription. Due to the nature of her job she is unable to disclose that she takes cannabis daily, despite the fact her prescription is legal. “There’s still a stigma about cannabis in this country, she says. “A lot of people don’t even realise they could be eligible

Laura and Dr Sally Ghalzaleh, will take part in an upcoming webinar series, exploring the role of cannabis medicines in women’s health. The first episode on Wednesday 12 May at 7.30pm will focus on women in pain and their battle to get a diagnosis. Other speakers include Abby Hughes, outreach director of PLEA and an endometriosis patient and Sarah Higgins CNS with over 10 years’ experience working in the NHS and women’s health lead for Cannabis Patients Advocacy and Support Services (CPASS). The event is hosted by Cannabis Health in association with Integro Medical Clinics and CPASS, find out more and sign up for free: www.cannabishealthnews.co.uk/why-women-in-painare-turning-to-medical-cannabis/

“I feel hugely let down by the system”

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Medical cannabis patients report being left without medication, as supply issues become a “major concern” for the UK sector, reports Sarah Sinclair. 59

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

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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 medication. “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 UKmanufactured 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.

More people are aware of cannabis medicines now, but unfortunately that means my care is decreasing

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

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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 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 laserfocused on constantly improving our services and moving

The current supply is coming under extreme pressure and there’s only one victim - the patient

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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Patient voices PLEA’s recently-formed Patient Working Group is committed to ensuring patient’s voices are amplified as the UK medical cannabis sector develops - but it’s also at the heart of a much-needed community, free from stigma and shame. 62

“When I first joined I didn’t know what they were talking about,” says Eppie who became a member of the Patient Working Group (PWG) earlier this year. “I’d only ever smoked cannabis, I had so much to learn, but everyone was so welcoming and they encouraged me to ask questions. “It was so positive to see people of all ages and backgrounds talking about cannabis.” One of the core aims of PLEA (Patient-Led Engagement for Access) is to empower patients to share their experiences with medicinal cannabis. Founded in 2020, it was borne out of the need for an independent, non-profit organisation which could stand up for patients and challenge the inequalities in accessing cannabis in the UK. As the industry develops, the PWG is a natural next-step in bringing together patients to ensure their needs are always at the heart of the sector. “PLEA has been built by patients for patients,” says chair and outreach director Abby Hughes, a medical cannabis patient herself. “We wanted to create something that was genuine, where there was no hierarchy, just a group of patients leading the way. “We should be centred and amplified in this sector and that is exactly what we are doing by giving patients an opportunity to share their stories.” Members are encoruaged to attend monthly virtual meetings where the latest opportunities in patient advocacy are shared, as well as personal experiences.

In March the PWG launched its new patient resources platform, offering a step-by-step guide to accessing a prescription, including videos of their own advice and experiences. It also features the first independent clinic directory where patients can compare their options and make informed decisions about their treatment, something which they felt the sector was desperately lacking. Speaking to members of the PWG it’s clear they all share the same mission - to improve access to cannabis for patients on the NHS - but what they also have in common is the value they have found in getting to know other patients. And of course, having a community which is from the stigma they face out in wider society. “I didn’t know any other patients and it was hard to find out about the different treatments,” says Gillian. “It’s helped massively to know that there are other people in the same position.” Margaret had recently lost her job and was struggling to find the right medicine when she joined the PWG. Now she has taken on a role on the organisation’s management committee to help drive their mission forward. “Having that peer support helped me realise that there were other options if something wasn’t working,” she says. “In the cannabis space, there can be a lot of competing motivations and it can get really overwhelming. Having a group of people around you, who share the same goals is important. It gives you a safe space.” For more information on the PWG and resources, visit www.pleacommunity.org.uk/patient-working-group

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Eppie Louise, 26

I was diagnosed with Type 1 diabetes aged eight and have a number of other conditions such as gastroparesis and anxiety and depression. I’m also a carer for my mum and a support worker for patients with brain injuries and mental health issues. Cannabis gives me an appetite to ensure I can maintain my blood sugars, as well as helping my sleep and managing my anxiety and depression. But not having a prescription means I live with the uncertainty of fluctuating prices and inconsistent products. With the support of the Patient Working Group I am exploring the options of a legal prescription. It’s so positive to see people of all different ages talking about cannabis. The way that it is so normal for them is really refreshing. It’s actually helped me become more accepting of my own cannabis use.

Gillian, 39

I was diagnosed with fibromyalgia in 2018, but only after six years of living with debilitating, unexplained pain. Since I have had a prescription for cannabis I can take the kids to school again, I can make them dinner and spend time with them doing things we enjoy. It’s definitely made me a better mother, but I was still nervous about speaking out due to the fear of facing backlash. I joined PLEA’s Patient Working Group to connect with other patients and it’s helped massively to know that there are other people in the same position. People don’t talk about cannabis, it is frowned upon. I can’t bring up my vaporiser with mums in the playground, even though it’s perfectly normal to joke about opening the wine at 11am.

Margaret, 39

I’d been sick for a really long time when I was diagnosed with Ehlers-Danlos syndromes (EDS) aged 34. It was a relief to get a diagnosis but there’s not many treatment options available. As an immigrant, moving over to the UK from the US three years ago, taking the risk in accessing cannabis on the street was never an option for me, so when Project Twenty21 launched last year I thought I could finally afford to give it a go and try to get some quality of life back. My cannabis journey wasn’t a straightforward one, it took time and effort to find what works for me. Six months

on I actually understand the epiphany of sorts many patients experience. My mood, baseline pain levels, activity levels, focus, sleep quality, and digestion are all much improved and my gastroparesis is the most well managed it’s been in at least 10 years. There are some very strong opinions in the cannabis space about how patients should be able to access these medications, but every patient has their own story and it’s important for us to work together, because we all have the same end goal.

Jonathan, 28

I started consuming cannabis about six years ago when I was having trouble sleeping. I didn’t understand why it helped at the time, until I went to see a doctor while living in Israel who diagnosed me with PTSD. Having that conversation was a huge relief and it would never have happened if I had not been able to speak openly about my cannabis use with that doctor. When I came home I self-referred to a medical cannabis clinic in the UK. It’s hard to describe what it means to have a prescription, it has enabled me to live a normal life and to enjoy England without feeling like I have to suppress a part of myself. Getting a prescription gave me such a boost I wanted to talk to other people about it. It sounds a bit old school, but cannabis can bring people together.

Abby, 32

Cannabis has always been a part of my life, but I didn’t know I was consuming it medicinally until I was diagnosed with endometriosis in 2012. I was eventually diagnosed with EhlersDanlos syndromes in 2017 and all of the symptoms that I was experiencing started to make sense. It’s only now that I’m realising the extent of the impact cannabis has had on my life. I recently found out that I am autistic and have been diagnosed with ADHD - looking back I believe I have been masking for years with cannabis. I’ve used it to cope with work and social situations, it’s how I got on in the world. I’ve got so many different symptoms but the one thing they all have in common is that cannabis helps. Getting a prescription in 2020 was life-changing for me. I work on PLEA every day - there isn’t a day off for us - but I’m a patient too, I’ve got to look after myself first to be able to do that and it’s cannabis that enables me to do that.

Read their stories in full as part of the Patient Voices series at www.cannabishealthnews.co.uk

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“ I am still at the bottom of a mountain trying to climb my way to the top” During Endometriosis Awareness Month this March, Sarah Sinclair spoke to LA author and BuzzFeed editor Lara Parker about living with the condition and finding relief in cannabis.

When BuzzFeed editor Lara Parker opened up about living with endometriosis in an article in 2014, she learned that there was power in numbers. She received the diagnosis less than a year before. But she had been battling excruciating cramps, painful sex and a raft of other debilitating – and unexplained – symptoms since her teens. It took seven years for Lara to be diagnosed with endometriosis. If that seems like a long time, it’s not, relatively speaking. Seven and a half years is the average length of time it takes for a patient to be diagnosed, despite the fact that the condition affects around 1.5 million women in the UK. Since that first article Lara has become something of an icon for tens of thousands living with endometriosis and chronic illness – particularly women who feel silenced, disbelieved and let down by gender bias in the medical system. In 2020 her first book came out, aptly named Vagina Problems, chronicling her journey in an attempt to provide for others what she wished had been available to her.

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But there’s another reason Lara’s 50,000 plus Instagram followers show up (apart from the steamy shots). She openly, unashamedly, shares the therapeutic effects that cannabis has on her symptoms and overall health and wellbeing. Living in Los Angeles she has widespread access to legal cannabis, but has still faced stigma and hid it from her doctors initially. Speaking to Cannabis Health, she reveals how the plant has changed her view of conventional medicine and helped her take control of her own health.

It’s hard to overstate the impact that cannabis has had on my life

CH: Can you tell me a little bit about your current diagnoses and what the journey was like to get to this point? Lara: My current diagnoses are endometriosis, adenomyosis, and overall pelvic floor dysfunction. It was a really long and difficult journey to receive these answers. I started experiencing severe symptoms that were disrupting my life when I was just a teenager — around 15 years old. It wasn’t until nearly six years later that I was given my first diagnosis of endometriosis after insisting that a doctor perform a laparoscopic surgery. Since then, it’s been a constant uphill battle to not only find doctors who are knowledgeable about these conditions, but who believed that I deserved relief.

CH: How is your health at the moment and how do your symptoms impact your day to day life? Lara: My health is up and down. I had a second surgery in January of 2020 to treat my endometriosis and my appendix was removed during this procedure. In some ways, I notice a positive change in my health since the surgery, but in many other ways, I am still struggling. I was put on an excessive amount of prescription drugs prior to the surgery and have spent the last eight plus months attempting to wean off of them. This has added so much stress and symptoms onto my life. In the midst of Covid-19, I was living in the epicentre of the world for the virus for several months. I had to forgo getting care for my illnesses because of my fear of getting Covid and adding yet another health issue on top. The reality of the situation is that there is no cure for endometriosis. I am maybe better than I have been in the past, but I am still at the bottom of a mountain trying to climb my way to the top. CH: How did you first discover the medicinal benefits of cannabis? Lara: It was by accident, really. I just happened to be dating someone who enjoyed smoking cannabis and

would do it fairly often. One day, I was having a horrific pain day when he suggested I try it out and see how I felt. The relief was immediate. I had never experienced anything like it before. After that I began to explore more. I went to dispensaries and asked them questions and I tested out any products that I could get my hands on. CH: How has it improved things for you? Lara: The better question would be how hasn’t it improved things for me? Cannabis has given me an appetite when absolutely nothing else has, it has given me an ability to orgasm in the midst of pelvic pain, it has helped my stress and anxiety levels in the midst of dealing with chronic illnesses, and has helped my pain levels like nothing else ever has. It’s hard to overstate the impact that cannabis has had on my life.

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CH: Did you speak to your doctors about it and were they supportive? Lara: At first, they were not. I was so excited to have found something that genuinely seemed to help me that I could not understand why my doctors weren’t feeling the same enthusiasm. I sort of stopped bringing it up and almost consumed it in secret for a while, but the more I experimented with it and the more it helped me, the more angry I became. I eventually chose to stop seeing any of the doctors who were unsupportive of my cannabis use. Now, when I assemble a new team of doctors or visit a new one I am very firm. I use this plant. It helps me. If you have a problem with that or make condescending comments about it, I will walk and I will no longer be a patient of yours – and I will make sure no one in my circle is either. It’s past time for doctors to realise the medicinal benefits that can be found in this plant. CH: Has it changed your opinion on pharmaceutical drugs and conventional medicine? 66

Lara: Yes, unequivocally. I was never a huge fan of ‘big pharma’ prior to discovering cannabis simply because it never really seemed to work for me. I was always left with an intense side effect or two which would then have to be treated with more pharmaceutical drugs. I was starting at a level of being in pain and felt like I just kept adding on layers and layers of other issues and it was extremely demoralising. I support ‘big pharma’ if it works for you, it’s absolutely someone’s own personal choice. What bothers me, however, is that many people aren’t even allowed access to cannabis to even see if it could help them in place of pharmaceuticals. It’s quite disgusting, really and I hope I see it change in my lifetime. CH: Living in LA where cannabis is easy to access, how does it make you feel that many other patients don’t have this?

mail with a bunch of pictures of me smoking cannabis with the words “Are you proud?” written on each one. CH: As someone with a large following on social media, how do you deal with people offering unsolicited advice and telling you how to manage your own health? Lara: I have had to learn how to set boundaries and stick to them. I have had so many people get angry with me simply because I say to them, ‘I didn’t ask for your medical advice, and I don’t want it’. But it’s been absolutely crucial for me to do so. It’s very difficult to be inundated with commentary on your body constantly. If I wanted advice or help, I would certainly ask for it. CH: You’ve chosen to use your platform to help others, what impact does that have on you as a patient yourself? Lara: It has given me the greatest gift of all; to know that I am not alone and that no matter where I am in my struggle, someone else is right there with me. There is power in numbers and I believe that our community is just getting started. CH: What needs to change about how healthcare treats people with endometriosis and other invisible conditions?

Lara: It’s enraging. It’s mind-boggling that we have access to such an amazing plant and that others don’t simply because their elected officials don’t know how to read books and use their brains.

Lara: So much, we need a complete rehaul of medicine. We need patient-forward care. We need holistic approaches. We need medicare for all. We need western doctors to drop the narcissism and admit that they actually don’t have all the answers, not even close.

CH: You’re very open about your cannabis consumption, have you experienced stigma because of it?

CH: What is one thing you would like people to know about endometriosis?

Lara: Certainly, but not at a level that someone who was not white would, I am sure. I grew up in a very small, conservative town in the midwest and a lot of people there still associate cannabis with being some sort of murderer or dangerous person. This past weekend, actually, my parents received an anonymous note in the

Lara: It is a whole body disease that impacts every single part of someone’s life. It needs to be treated as such. Vagina Problems: Endometriosis, Painful Sex and Other Taboo Topics is available now. Follow Lara on Instagram @laraeparker

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Covering CBD from every angle

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“CBD gives me clarity”

Gary Brennan ‘died’ three times in a freak motorbike accident, undergoing 54 operations to fix his broken body. Eleven years on he reveals how CBD allows him to function in order to help other victims of trauma.

On 28 February 2010, father-of-four, Gary Brennan was on his way home from the supermarket when he 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. His injuries were so severe that he was initially declared dead at the scene. Paramedics were eventually able to resuscitate him before he was helicoptered to Leeds General Infirmary to undergo emergency surgery. But during the operation, his heart stopped twice and his family were warned that he may have just a few hours to live. Gary was placed in an induced coma, relying on a life support machine to breathe. Miraculously, Gary survived. Undergoing a total of 54 operations and battling injuries that doctors deemed barely survivable, he was administered a plethora of drugs to keep the pain under control. “The accident was life-changing to say the least,” says the 63-year-old who had run a successful bakery business for 20 years.

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“I got through the operations, but 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 was “destroying” his brain. Bed-bound with pain and suffering from a relentless medication plan, Gary slipped into a period of depression and even at one point considered suicide. “It brings tears to my eyes just thinking about it,” he says. “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” 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 adds. Knowing he had to find an alternative, he began to research CBD. Although he was sceptical at first and questioned whether the benefits were merely a placebo effect, he found that the cannabinoid was helping reduce his pain while still allowing him to keep a “clear” head. “Now I’ve got clarity. I can get out of bed in the morning,” he continues. “The pain is always going to be there, but it’s handled in a different way. CBD 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 his 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. 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 such as 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,” he says. “You have to use stronger and stronger doses in order to get it into your bloodstream.” Being able to function better has also meant that Gary can focus on helping other patients who have suffered major trauma and their families. Spurred on by the huge mental and financial toll that the accident had on their family, Gary and wife Shirley set up Day One Major Trauma Support. “There was very little help there that we knew about, but what was there we had to find out about ourselves. There was no one around to tell us where to go,” he says. “It was horrendous for Shirley, if there had been help there for her, someone to talk to, it would have eased her burden.” The charity, which is now rolling out its services to all 27 major trauma centres in the UK, provides financial assistance, legal advice and practical and emotional support for patients and their loved ones. Last year it received a £1 million donation from the Wyss Foundation to help the charity continue its work. “Help is there first-hand, no matter what, so nobody’s left in the lurch,” Gary adds. “In the hospital I just wanted to give Shirley and the kids a big hug. Although I was the badly injured one, in many ways they were more injured than me, close families are like that.”

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Almost all CBD users feel less stressed New data shows that people are most likely to report using CBD products to reduce feelings of stress and anxiety, as well as to improve their quality of sleep, but THC also has a role to play in finding “mental equilibrium”. 70

A team of researchers from the UK and Denmark conducted an online survey of 387 subjects experienced with the use of CBD. Participants in the survey resided primarily in the UK, Denmark, and the US. Mitigating anxiety was the top-ranked reason for the use of CBD with 43 percent of respondents reporting that they take CBD for this reason. Of these, 87 percent said they felt less anxious afterwards. This was followed by sleep problems – with 43 percent reporting that they used CBD to help them sleep better, to reduce stress (37 percent), and for purposes of “general health and well-being” (37 percent), with 92 percent of those reporting reduced stress levels afterwards. Seventy percent of those surveyed reported having only initiated the use of CBD within the past 12 months. Writing in the Journal of Cannabis Research, authors concluded: “CBD is used for a wide range of physical and mental health symptoms and improved general health and well-being. A majority of the sample surveyed in this study found that CBD helped their symptoms, and they often used doses below 50 mg. Out of the four most common symptoms, three were related to mental health. “Self-perceived stress, anxiety, and sleep problems constitute some of society’s biggest health problems, but we lack adequate treatment options. Further research is needed into whether CBD can efficiently and safely help treat these symptoms.” The survey was led by Dr Julie Moltke, a prescriber of medical cannabis in Denmark and author of A Quick Guide to CBD. Specialising in pain, stress and mental health, Dr Moltke has carried out extensive work into stress reduction and has seen cannabis help many of her patients find “mental equilibrium”.

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She told Cannabis Health that while she has experienced first-hand the benefits of CBD for relieving stress and anxiety, THC also has a role to play. “Cannabis is an extremely promising drug for the treatment of mental health concerns,” said Dr Moltke. “I tend to use CBD a lot for anxiety and for stress, but I also work with many people with chronic pain who use medical cannabis containing THC, and there’s no doubt that this also has great effects on their quality of life and anxiety.” She continued: “The tendency to overthink and worry is removed by cannabis. I have a lot of patients who are really benefiting from the combination of THC and CBD, which seems to establish that mental equilibrium and have a balancing effect on their mental health.” Although no psychiatric diagnoses are approved for treatment with cannabis-based medicines yet in Denmark, many of Dr Moltke’s patients living with chronic pain and fibromyalgia also display symptoms of anxiety and Complex PTSD (CPTSD), which is caused by social trauma, such as emotional abuse or a traumatic event in childhood. “Often in young people with fibromyalgia and unexplained chronic pain there is some kind of trauma at the root of their PTSD and mental suffering,” said Dr Moltke. “This group of patients respond best to medical cannabis because it can help their pain but it also helps balance the endocannabinoid system and treat the chemical imbalances that have been triggered by the trauma. “We see a lot of people self-medicating with cannabis to treat the symptoms of PTSD and social anxiety, but as we are not authorised to use cannabis for these conditions, we can only look at it as a secondary outcome.”

Four tips for avoiding burnout

‘Burnout’ may have become something of a millennial buzzword, but it’s not to be taken lightly – ignoring the signs can lead to serious mental and physical symptoms. ‘Burnout’ is a severe stress condition that can lead to serious physical, mental and emotional exhaustion. Although the symptoms are not always easy to spot, they are brought on by continuous stressful situations, for example caring for ill family members, working long hours or receiving upsetting news. The physical symptoms of a burnout include feeling drained, lowered immunity and a change in appetite or sleep habits, paired with the sense of failure, loss of motivation and detachment.

Turn to others

Reaching out to those closest to you doesn’t make you a burden. Most friends and family will be on hand for you to confide in and help to resolve the issue. Although we have spent the past year in lockdown, being more sociable with those around you can be a great distraction and ease any worries that you’re alone or disconnected. Going for walks with friends or taking part in online group calls can help you to realise who is there for you.

Change your outlook on work

If your job feels like you’re underappreciated or drowning in work, an effective way to combat job burnout is by speaking to your colleagues and management. Speaking with your manager about the overload of assignments and the effects of your current situation, most executives will take this on board and help relieve you of the amount of work, offer a holiday or do what they can to make you feel happy in the workplace. Finding a balance is also important. You need to be able to find the middle ground between work, hobbies, family and friends.

Tech detox

Although technology is a wonderful thing, we can often find ourselves scrolling for hours without realising the impact it has on our mental health. Excessive use can cause feelings of anxiety, depression and isolation. Make sure you take frequent breaks from technology when you can. Putting the phone down and picking up a book or enjoying some fresh air can massively boost your mood. You may not realise how reading the negative news stories or feeling FOMO (fear of missing out) can impact you. And remember, social media often isn’t real life.

Try CBD products

CBD products can help reduce anxiety and lift your mood. Particularly last year, anxiety and stress were highly reported due to the Covid-19 pandemic, where people resorted to CBD products to manage such stressors. It may assist you to relax and rest without feeling like you’re on the edge and from burning out while trying to be productive.

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The chaos of the Covid-19 pandemic has disrupted what were already pretty shaky sleep patterns for millions of people in the UK alone. Could CBD be the answer? 72

Just a dream? A good night’s sleep is crucial for both our physical and mental health, with ongoing sleep deficiency being linked to a number of high-risk health issues such as heart disease, diabetes and stroke. Despite National Sleep Foundation guidelines advising that healthy adults should aim for between seven and nine hours, previous studies have shown that, on average, Brits are only getting around six hours and twenty minutes shut-eye each night. The Covid-19 pandemic and tolls of the past year have only wrecked further havoc on our sleep patterns. Research from a team at Southampton University found a sharp rise in the number of Britons suffering from insomnia and anxiety-induced sleep problems.

According to a survey of 800 UK residents by CBD brand Trip, a staggering 85 percent believe the most recent lockdown has negatively affected their sleeping habits, with over two thirds saying that 2020 was the most stressful year of their life. Financial worries, lack of a social life and spending too long watching TV or on our phones have been named as the top three reasons we are struggling to get our eight hours every night. But nearly 80 percent of those surveyed said they would be open to trying CBD products to help them sleep better, and just under 15 percent said they already had done and believed it worked. This correlates with findings from ecommerce marketplace Alphagreen, which recently found that sleep was the third most common reason that shoppers were turning to CBD. Following a survey of 5,000 CBD users - the largest in the UK to date - the platform estimates around 2.17 million people could be using it to help them sleep. While the effect of cannabis on sleeping patterns remains an underdeveloped area of research, interest is certainly growing as we search for natural alternatives to potentially addictive sleep aids such as Valium and zolpidem. The most common sleep condition in adults is insomnia, which is thought to affect around a third of people in the UK. The symptoms of insomnia can be caused by a number of external factors, such as too much caffeine or noise, but the most common cause is thought to be stress and anxiety. The stress hormone, cortisol, is usually at its highest level in the morning, however those with insomnia or other similar conditions will likely experience higher than normal levels at night.

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Early research into this area looks promising, with a 2019 study which reviewed monthly documentation of anxiety and sleep quality in 103 adult patients, finding that anxiety scores decreased within the first month in 80 percent of patients, and sleep scores improved within the first month in 67 percent. Meanwhile, a paper published in the Journal of Psychopharmacology found that systemic acute administration of CBD appears to increase total sleep time, in addition to increasing sleep latency in the light period of the day of administration. It has also been noted that in smaller doses, CBD stimulates alertness and reduces daytime sleepiness. While it may seem counter-productive to increase alertness in insomniacs, this is actually very important for daytime performance and to improve strength and consistency of the sleep-wake cycle, therefore improving sleep patterns. A review from 2017 echoed these sentiments, with researchers noting that preliminary research into CBD has found that CBD “may have therapeutic potential for the treatment of insomnia” and that it “may hold promise for REM sleep behaviour disorder and excessive daytime sleepiness”. Another way in which CBD may help those suffering from poor sleep is by aiding relaxation. While CBD won’t get you high like THC, the main psychoactive ingredient cannabinoid found in cannabis, it can provide similar feelings of relaxation. CBD is a CB1 antagonist, meaning it blocks or modulates intoxicating or euphoric effects, leading many to believe that the remedy is a good way to decrease the negative side effects of THC and instead help users relax and destress, which can be crucial when it comes to getting a good night’s sleep. While it’s clear more research is needed to determine the exact effects CBD has on sleep, it’s important to note that preliminary findings are heading in the right direction to show that it could be an alternative, natural remedy for those suffering with disorders.

How to take CBD for a good night’s sleep Find the right method for you

One of the most common ways to take CBD is as an oil, but other, more recently-developed, products include gummies, beverages, lotions, salves, and cosmetics. If you are looking for a general mood enhancer, a dietary supplement might be a good option, whereas if you’re looking to target a specific condition – such as insomnia taking an oil, capsule or gummy might be a better way to obtain a higher, more concentrated dose. There is even now a range of CBD-infused bedding on the market, filled with microcapsules of CBD which burst throughout the night to continually release microdoses of the cannabinoid.

Start low, go slow

Whatever you’re using CBD for, it’s important to start low and go slow, and sleep is no exception. A good place to start is with 10 to 20mg a day. First-timers should start with this dose for a week to ensure that it is well-tolerated with no unwanted effects or an allergic reaction. If this doesn’t feel like it’s working, try upping the dose by 5mg a week until you hit the sweet spot – it is thought that 25mg a day is a realistic goal for treating insomnia. The Food Standards Agency (FSA) – which is responsible for regulating CBD as a novel food – recommends that healthy adults take no more than 70mg a day, unless under medical direction.

Other factors

CBD can help promote relaxation to facilitate a good night’s sleep, but it’s not a magic cure-all. Make sure you’re taking other measures to help your mind and body switch off. Avoiding screens after a certain time, establishing a calming routine including a hot bath or breathing exercises, adjusting the room temperature and light and investing in a supportive mattress and pillows will all help you to drift off peacefully.

CBD may have ‘theraputic potential for the treatment of insomnia’

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A Lady in the bedroom Having secured a foot in the door in the world of wellbeing, Alexandra Dunhill, the great-granddaughter of the luxury goods brand founder, Alfred Dunhill, is launching her own range of CBD intimacy products. 74

After seeing how much CBD was helping her son Piers, Alexandra Dunhill became “fascinated” with the cannabis plant. “Growing up Piers suffered from anxiety. He had trouble concentrating and was at times a challenging child. ” says the mother-of-three. “We’d been to a few different doctors who tried him on various medications, none of which worked for him.” After school, Piers moved to Los Angeles and began working at a cannabis publication. It was whilst visiting him in 2017, that Alexandra was first introduced to the potential health and wellbeing benefits of CBD. “I noticed the difference in Piers and how much CBD was helping his anxiety, general health and that’s what motivated me to start on this journey,” she says. “It was very early days, but I attended various conferences and events over there and wanted to share this amazing experience back at home in the UK.” After spending time sourcing the right manufacturer and suppliers and perfecting her branding, her CBD wellness range Lady A, launched at the end of 2019. Following in her great-grandfather’s footsteps, Lady A is a cut above. Where Alfred Dunhill designed luxury menswear and accessories, Alexandra has created a luxury, femalefocused range of tinctures, gel capsules, balms and vapes, that she would be proud to pull out of her handbag or display on the dressing table. She wanted the brand to be void of any stigma still associated with cannabis and ultimately aim to help

people live a happier, healthier and balanced life whatever their age or background. And there is no reason why men can’t use the range too. “I noticed there was a gap in the market, a lot of brands were very masculine and sports-focused,” she explains. Alexandra has been taking CBD herself since returning from America, saying she has never liked taking pharmaceuticals unless absolutely necessary. “I’m quite an active person and believe if you can find a natural route to health issues that works for you all the better.” When people comment on how well she looks she always puts it down to CBD, believing it may even have helped prepare her body to beat coronavirus last year. “I’ve been taking it for quite a long time and people always comment that I look so well and calm, so it must affect your overall balance,” she says. “I caught Covid last year and didn’t even know I had it. I never know if it’s just being healthy or maybe it’s the CBD.” Increasing numbers of women are finding that CBD is helpful for complaints such as stress and anxiety, period pain and stomach cramps, as well as regulating hormone levels and managing some of the symptoms of menopause. In particular, women living with endometriosis and other gynaecological conditions report it helps relieve pain, inflammation and painful sex. The latest addition to Lady A, launching this spring, is an intimacy range called After Dusk - including a CBD

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lubricant, massage oil and silk eye-mask - designed to be “fun and a little bit sexy” while also having potential benefits for both partners in the bedroom. “Sex is an important part of life and overall wellbeing. As a female-focused wellness brand this is an area that I couldn’t ignore,” says Alexandra The anti-inflammatory effects of CBD are thought to help if there is any discomfort and pain during sex, as well as increasing blood flow and sensitivity in the area. A few drops of CBD oil beforehand may also reduce any anxiety and aid relaxation so the whole experience is more enjoyable for everyone. “Intimacy can be quite a barrier for some, so I wanted to create products that people may find helpful,” she adds. “The range has been designed to look beautiful, discrete and not embarrassing to have lying around or to receive as a gift.” The business is still very much a family affair, with all helping out to get things off the ground and the children haven’t been too embarrassed by their mother bringing out an intimacy line. Lady A launched in Selfridges last year and is stocked in it’s new in-store dedicated wellbeing space which opened on 26 April. Alexandra is currently looking at extending the cosmetics range further, she adds: “Covid has probably helped with the popularity of the wellness industry, we’re all stressed and worried and the pandemic has given us more time to concentrate on our wellbeing.” www.ladya.health

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Green rush More than six months after a landmark decision to let cannabis firms into the heart of the UK’s financial establishment, what next? Asks Sean Seddon, editor of our sister publication, Cannabis Wealth.

In September 2020, the Financial Conduct Authority (FCA) responded to a surge of interest from companies hoping to list on the London Stock Exchange by clarifying entry requirements for cannabis companies. It meant the door was opened for medical cannabis and CBD companies with valid Home Office licences to raise funding via the LSE. The FCA also established a process allowing overseas companies to prove their operations wouldn’t constitute ‘proceeds of crime’ under UK law, providing a landing strip for international firms looking for a new home. It marked a major breakthrough for firms denied the opportunity to raise capital on the financial markets by a conservative regulatory regime. A guidance consultation will take place in due course – a start date is yet to be confirmed by the FCA – but the move has already changed the outlook for cannabis firms looking for investment. Since then, three companies have listed on the LSE, with Australia-based biopharma firm MGC Pharma making history on 9 February by becoming the first. It was joined a week later by Kanabo, an Israeli-based firm which entered the market via a reverse takeover by Spinnaker Opportunities. Cellular Goods – the first UK-based company to list, buoyed by public interest in star-backer David Beckham – floated on the LSE on 26 February. Each time, shares were described as ‘significantly oversubscribed’ with prices soaring, settling and holding steady since. But who’ll be next to take the leap? After a trio in quick succession, more than a month has now passed without a further listing. Jersey-based Northern Leaf Limited – which has a rare commercial licence to grow and sell medical grade cannabis – recently announced they have raised £14m

ahead of a planned LSE listing later in the year, while CBD brand Love Hemp has also signalled its intentions to list. Will there be a larger influx of companies looking to London in the months ahead? Alastair Moore, director of Hanway Associates, thinks so. The industry expert says moves are afoot which could see more cannabis companies heading to the LSE. He told Cannabis Wealth: “There is a flurry of activity behind the scenes as anyone with a decent operation is considering the possibility of listing. “Access to private capital has been tough for a lot of UK cannabis companies so the LSE offers a very real chance to raise the kind of money these fast growing companies need.” Robert Jappie, a partner at law firm Ince and expert in cannabis regulation, shares this optimism and expects to see a flurry of activity over the coming months. He credited the trio of companies to list already with ‘paving the way’, adding their ‘phenomenal reception’ proves there is an appetite for more. He said: “I have clients who started their businesses really early and have been working hard to build them up for years. “I hope the next 12-18 months will see people rewarded for that hard work. “Businesses will be in a good position to take it to the next level. It’s a really exciting time.” The allure of a seat at the big boys’ table can not be overstated in the world of finance. Moore – whose consultancy firm specialises in supporting cannabis firms – said the seal of legitimacy conferred by the LSE would continue to attract to interest. “An LSE listing is essentially a stamp of mainstream approval for a company operating in what is perceived as a risky sector.

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SELL

BUY

An LSE listing is essentially a stamp of mainstream approval for a company “Not only is it better optics for investors, there is a high level of compliance and due diligence they will have had to go through. It is a positive for the sector as a whole, as it creates institutional trust.” Key directors in the industry will also hope that seal of approval filters up to the people writing regulations. When Kanabo announced it was listing in London, founder Avihu Tamir said he believed it would ‘game-changer’ for the sector and demonstrated that the UK could be following in the footsteps of North America in its acceptance of medicinal cannabis. He told Cannabis Wealth earlier this month: “There is going to be a swift change in Europe. I think that what we saw starting in the US and Canada around like five years ago is now reaching Europe. “Once you have the public market in a certain country being opened, you suddenly see the shift in how the cannabis industry is being perceived by decision-makers.” The feeling of progress in the UK has been bolstered by moves abroad which has opened up huge new markets and pointed to opportunities in the future. France recently launched its first medical cannabis trial, possibly presaging an overhaul of laws across the channel. Across the Atlantic, New York politicians agreed a deal to legalise recreational use and Mexico became the world’s largest state to go for full liberalisation, sure signs of a global market which is changing rapidly. With a positive mood music pervading the industry internationally, Moore believes London could be well placed to benefit: “With the recent listings and FCA clarifications the City has made it clear it wants to be an important part of what is fast becoming a global industry. “I’ve always thought the UK had the right ingredients to be the best place for progressive cannabis companies to operate

– a heritage of world-class pharmaceutical companies, a global finance hub, it’s an English language destination for North Americans entering the European market, and there are leading creative and professional services.” Closer to home, the vexed issue of CBD products being designated as novel foods has hung over the sector throughout 2021. But with validations set to start being signed off in April and ‘heads turned’ by the success of medical cannabis firms on the LSE, there could be a renewed spring in the industry’s step going forward. Jappie said: “The thing that is most important is for the LSE is that they have confident businesses listing with them are compliant with the law. “That’s straightforward for a medical cannabis company. With CBD it’s always been a bit more difficult but the novel foods process should effectively clear that up and provide a clear route to compliance.” The changes also helped to keep London competitive with competing exchanges like Frankfurt – and as London continues to define its investing environment post-Brexit, the shift could be seen as an attempt to prepare the city for competition over the fast-growing sector. “Brexit is causing huge disruption in terms of moving products around internationally”, Jappie told Cannabis Wealth. “There needs to be some benefits – making the UK the best place in Europe for cannabis companies to operate could be a vital one. “If businesses don’t see support from regulators here they will go elsewhere to places like Germany – but things have started to change here.” For more business news and anaylsis from across the global cannabis industry visit www.cannabiswealth.co.uk

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Inside Scotland’s first medical cannabis production facility 78

With a 120,000 square foot facility under development, Hilltop Leaf is well on the way to becoming one of the largest medical cannabis production companies in the UK. Cannabis Health hears about its groundbreaking new cultivation facility on the Scottish borders.

The UK-based private cultivation and extraction business, Hilltop Leaf is constructing Scotland’s very first medical cannabis cultivation and production facility. Once completed, the company will become one of the UK’s first domestic cannabis brands. The UK currently has an estimated 1.4 million medical cannabis users, the majority of whom source their products from imports via private clinics, the illicit market or from plants grown at home. Hilltop is aiming to change this. With its £15 million facility located in Dumfries, the company says it is on a mission to produce cannabis-based medical products, including full spectrum cannabinoid oils and Active Pharmaceutical Ingredients (APIs), that are suitable for specialist prescription in the UK. The 120,000 square feet site will contain both a cultivation and extraction facility allowing the company to produce cannabis-based medicines that are grown, processed and manufactured in the UK, reducing the country’s reliance on imports. “One of the biggest issues that we face in the UK is access to cannabis products, which I think is one of the reasons

why the market has developed so slowly,” Hilltop CEO and co-founder, Hamish Clegg, tells Cannabis Health. Having built relationships with clinics and distributors including Sapphire Medical Clinic, Lyphe Group and Health House, Hilltop says its cannabis medicines could be prescribed to UK patients by early 2022. The site is built in an undisclosed, “secluded” area on the Scottish borders. Sheltered, free of pesticides and with an abundant clean water supply, the facility is situated in an ideal location for producing products that meet the EU’s rigorous GMP standards. The site also has potential to harness renewable energy to power its operations. Behind it is a wind farm which the company intends to utilise alongside its own running water to create a fully carbon-neutral facility. Having finished construction of the early shell, Hilltop is now progressing licence applications with both the Home Office and Medicines and Healthcare products Regulatory Agency (MHRA). It also plans to run a pilot in the coming months ahead of its application for a commercial cultivation licence. “We can’t go into immediate all-out production, we need

We have a desire to contribute to the scientific development of medicines to help people in this country

to solve the route to market first. This will enable us to define our products and select our genetic strains. “Our plan is to do something small; define our product with a pilot, which will be a modular grid within our facility. The end product initially will be destroyed but the plan is that once we’ve defined our products, we will then be able to apply for a commercial cultivation license,” Clegg says. The early stages of construction have been supported by £735,000 of Government funding from South of Scotland Enterprise, which Clegg says has “put the wind in its sails”. Hilltop is now embarking on an external capital raise to fund the next stage of the project. The company has EIS Advanced Assurance from HMRC for its ongoing seed round which aims to raise between one and two million for the engineering, design and early construction of the site. This will be followed by a series A equity funding round to finance site construction, QMS validation and staffing. Hilltop Leaf was launched in 2019 by Clegg, a former investment banker, and agricultural experts, Neil and William Ewart. Despite the lack of sun in Scotland, building a production site in the UK was important to Hamish and his team. “I want to help build the UK medicinal cannabis industry and be one of the early movers in that,” Clegg says. “We’re not in it for a quick buck. We’re investing hard cash, to develop infrastructure, develop relationships and develop supply chains, so that this is something to stay. “We’re proud to be a British company and we want to build a British industry to that standard.” As owners of the land on which the new facility is being built, co-founders Neil and William Ewart have strong connections to the local area. The south of Scotland is known to have higher-than-

We’re not in it for a quick buck, we’re investing hard cash

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average rates of unemployment compared to the rest of the UK and as the region also faces a number of healthcare issues, Hilltop hopes that the site will support the local people and the economy. Clegg adds: “There’s a big unemployment problem in the south of Scotland and it has many healthcare demands in that part of the country that could be helped by introducing medicinal cannabis as a clinical option. “We have tonnes of local support. The community, councillors and local MPs all wanted to build a medicinal cannabis business in the area that we’re [based] in. “We hope to be a big employer and someone who’s developing the local community in an environmentally friendly way.” Starting with an early headcount of less than 20 with roles across security, administration and quality assurance, Hilltop eventually expects to employ upwards of 50 people. Local contractor Paul Davison has already been enlisted to help with civil works, and with support from locally-based firm Mark Seed Forest and Land Management on the initial planning application, the project has largely been welcomed by the local community, according to Clegg. Alongside its plans to produce medical-grade cannabis medicines, Hilltop intends to import products to the UK. The company is working in partnership with MG Health, a medical cannabis cultivator and manufacturer based

When you see 1.4 million people going to the black market every day to selfmedicate you realise there is a massive need

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in Lesotho. The landlocked country bordering South Africa has become a hotspot in recent years for cannabis cultivation. Hilltop aims to bring MG Health’s products which are grown in the mountains two thousand metres above sea level - to the UK. COO of MG Health, Francois Ferreira described the UK as an “under-devloped” compared to other European countries such as Germany where cannabis-based medicines are more widely available, but the company sees a “real need” for the medicine amongst British patients. “When you see 1.4 million people going to the black market every day to self-medicate, you realise there is a massive need,” Ferreira says. “At some point, it has got to give. “If we are able to play a role in that, we’d like to. We’d like to be able to support the efforts of people campaigning for easier access, and we believe we have a product that can be unbelievably beneficial to people and to their lives in this country.” The first product that Hilltop and MG Health plan to bring to the UK is a high-THC flower containing 20 percent THC, a range of terpenes and other cannabinoids. “One of the reasons we want to partner with MG Health is because I’ve watched their journey in terms of quality assurance and quality plans and procedures,” Clegg adds. “Everything from their growing facilities, the way the

plants are treated and cared for, the consistency that is bought in; everything is done to good agricultural practice and EU GMP compliance. “We’ve got the partner, we’ve got the quality products here, it’s got the certification and we are in the stages of planning the supply routes from Lesotho to the UK, to the secure storage facility and to eventually get to the point where we can show this to clinicians, so they can prescribe it to patients.” With forecast revenues of £30.5 million per annum by 2023, Hilltop Leaf has ambitious plans to become one of the UK’s leading medical cannabis suppliers. The company estimates that by 2023, the total addressable UK market will amount to £360 million and with the support of its patient access partners, Hilltop aims to take 15 percent market share. According to Clegg, the company also plans to support the NHS develop the science surrounding medicinal cannabis. “We have the desire to contribute to the scientific development of medicines to help people in this country,” Clegg says. “We feel that as a medicine, cannabis and cannabinoids are very under researched and under explored. The NHS hasn’t adopted cannabinoids as a widespread source of product for patients yet, but I think that’s developing.”

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The heart of the industry Cryptocurrency, state of the art cold press technology and an AI drone that allows cultivators to produce up to five times the yield of an average farm: Cannabis Health speaks to the CBD company that is on a path to revolutionise the sector.

Hemp cultivators will know that only female plants can grow flowers; the component from which cannabinoids are extracted to make CBD products. Male plants on the other hand only produce pollen sacs, a useful tool for breeding but detrimental for farmers seeking to produce a high yield of usable hemp. In the 1970s, cannabis and hemp growers discovered that growing only female plants or removing male plants before they matured boosted both the yield and potency of their end product. They found that the longer a female plant is left unpollinated, the larger it will grow, meaning farmers can produce a greater number of flowers with a higher yield of cannabinoids. A 1998 study confirmed this, revealing that pollination of female plants resulted in a yield 56 percent lower than an unpollinated crop. To maximise their profits, some farmers inject a huge amount of time and resources into identifying and removing male plants before they release their pollen. However, distinguishing between the two sexes is a near impossible task. Male and female plants look almost identical until the flowering stage, at which point it is too late to prevent pollination. Farmers can buy feminised seed to sidestep this issue, however very few can justify the significantly higher costs compared to scattered seeds which contain both genders. But Irish company Greenheart CBD has partnered with Canadian technology firm, Zenadrone, to develop an artificial intelligence drone that can solve the problem. The six-foot drone features a robotic arm that can pinpoint and remove the male plants before pollination. The result is a crop consisting only of unpollinated female plants with space to grow to their maximum size. According to Greenheart co-founder, Paul Walsh, an average

farmer in Ireland would expect to produce around 200kg of dried flower per acre. Using its drone technology, Greenheart is able to yield 1,000kg per acre. “There’s nothing else like it in the world, it’s completely groundbreaking,” said Walsh. “It’s like when the tractor first came to the farm - well this is the new tractor.” The drone also serves as a security tool, with camera systems which are connected to a mobile app meaning farmers can monitor their crop 24 hours a day. And as well as boosting profitability by allowing for a higher yield, it also collects data throughout the process, ensuring full traceability of the hemp plants from the farm, through its production facility, where cold press technology is used to extract cannabinoids and terpenes from crops. As opposed to the more popular methods of extraction using CO2 or ethanol, cold press technology subjects hemp flower to high pressures at relatively low temperatures to produce an extract that contains the entire spectrum of cannabinoids and terpenes. Greenheart has now developed several cosmetic products along with three flavours of CBD-infused popcorn, with a new range of protein-based CBD products under development.

It’s like when the tractor first came to the farm

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Before venturing into the cannabis and CBD sector, Walsh built a career in blockchain technology, working for a number of multinational tech companies, including PayPal. After several years in the sector, he decided to return to his home country of Ireland to integrate the cryptocurrency system into the Irish hemp sector. In 2019, he teamed up with fellow entrepreneur, Mark Canavan, and the duo set out to address some of the key challenges faced by the sector. “When I was researching for a previous company, I was noticing that a lot of farmers were in a bad state of affairs,” Walsh said. “A couple were taking the risk and trying to grow hemp. When I got to them and asked them what the problems were, they had no infrastructure, they had no sales channels, they really didn’t know what they were doing or how to get this crop to market. “They could grow an absolutely fabulous crop, but when it came to the processing of the crop, and getting it to the market it was something that they were lacking [expertise] in.” The strict laws and regulations surrounding cannabis has led to CBD companies facing various issues with banking and payment processes. Many struggle to build relationships with mainstream payment providers and instead have to rely on high-risk payment processors with high fees to sell their products. In an effort to tackle these issues, Greenheart CBD made the bold decision to launch its own cryptocurrency called Punt, named after the old Irish currency. Through Greenheart’s mobile application, customers can buy its products and earn rewards and exclusive discounts for using the Punt. “It solves a lot of issues,” Walsh said. “There are lower transaction fees and it is very adaptable for our customers. The benefits of this cryptocurrency is that as the project grows, the price grows.” With the data gathered from the AI drone, coupled with the financial data collected through its mobile app, Greenheart is able to trace all of its products back to the original source and make the information available to the end-consumer. “We have a completely transparent chain, literally from the farm itself to the currency,” Walsh explained. “In our mobile app we have a QR code scanner so on every product that you get, you can scan the QR code and get access to all the information about the plants, the farm where it was grown, the processes it went through, the blend that it went through, what it was mixed with and the travel lifecycle of the product. “All the information needed for you to make a sound decision on whether this product is high quality, and whether it’s worth the money.” Greenheart’s efforts to bring cutting edge tech into the hemp sector hasn’t gone unnoticed. This year, the company

received an All-Star Award from the All-Ireland Business Foundation and Walsh was accredited as a thought-leader in innovation, technology and sustainability. Greenheart has experienced exponential growth since its launch and is now shipping its products to 49 countries. In its first year, the company grew by 500 percent and is expected to grow by a further 1,000 percent in 2021. The team is now developing a “plug and play system” so other farmers can use the innovative technology. The 40ft container can be installed on any farm and allows cultivators to immediately start growing their own hemp crops, manufacture products and get their products out to market. “This technology is very low cost and efficient,” Walsh said. “We’re taking all this technology and combining it together, making a plug and play system that you can drop onto any farm or any location in the world.” The young company now has its sights set on international expansion with a new production facility under construction in New Jersey, USA and plans to build another facility in Queensland, Australia. “We’ve grown exponentially and now we’re looking to expand globally to any farm or location in the world,” added Walsh. “This will enable farmers to start growing the hemp crop and producing a high quality product and with the drone recording the data we can relay that back to any government or government agency which requires full transparency.”

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Women leading the way in cannabis Sarah Sinclair meets the women challenging a lack of diversity in the cannabis industry, by launching an all-female networking group to encourage collaboration, tackle stigma and improve access for patients. 84

It was only my second day in the job when the invite landed in my inbox. At the time, the Women in Cannabis Leadership group met over Zoom every three weeks, with names such as Hannah Deacon and Vera Twomey among those in the email chain. Alongside them were leading researchers, prescribers, patients and the brains behind groundbreaking schemes such as Project Twenty21. Its founders, Dr Mala Mawkin, a former NHS doctor and now head of product development at chronic pain clinic, Cellen and Sophie Thompson, a communications professional at Aurora Healthcare, had met through an industry conference a few weeks earlier, at which both were struck by the lack of women represented. The pair took the bold move of sending out a mass email to every woman they knew working in the space, inviting them for a virtual coffee. “People started coming back to us, saying what an amazing idea it was,” recalls Mala. “There were some huge names in the industry, who felt they were lacking this group of people around them.” “The boys all had their networking groups and this was a way of democratising that and finding a way that we too could be leaders in the field.” The middle of a global pandemic, when travel was restricted and most of us were still confined to our homes, might seem like a strange time to launch a women’s networking group, but Sophie and Mala believe Covid-19 has actually been a “blessing in disguise”. “We would never have found the time every three weeks to meet in person and we wouldn’t have thought to do it on Zoom,” says Sophie.

We’ve already started stereotyping roles and no one is challenging this

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As a group we can hold people to account and get people to take cannabis seriously again

“We’ve got working mums in the group who are trying to juggle children, so I think it’s helped us that we’ve all been able to carve out this time to quickly join a call, even if it’s just for half an hour. “It’s amazing the power that you can get from just talking to each other.” Now with an active WhatsApp group, virtual meetings take place every three months. But it’s not all women sending love heart emojis back and forth (although there is a lot of that too) there is a much bigger strategy at play, in a bid to tackle some of the major challenges in the cannabis industry today. The group’s mission is to support patient access to medicinal cannabis therapy by building a partnership of women from key organisations in the medical cannabis space. Its vision is to see a world within the next five to 10 years, where medical cannabis is considered part of mainstream treatment in the UK. “There have been a lot of false promises in this industry and it’s people’s lives that are at stake here,” says Mala. “As a group we can hold people to account, call out bad practice and get people to take cannabis seriously again.” Made up of women who are considered to be leading the way in science, research, healthcare and patient advocacy, it aims to leverage the combined expertise of its members to improve education and raise awareness, to challenge barriers and limit stigma for patients requiring cannabis treatment. “One of the things I’m keen to do is make sure we’re broadening the people who are involved and addressing any gaps within the group, so we can maximise our impact across the industry with people from every cross-section,” continues Sophie. “It's not something that you’re going to change overnight, a perception is something that you’ve got to change through lots of small activities that build up how people talk about cannabis in medicine.” It goes without saying that the other driving force behind

the group is to improve diversity in the sector and pave the way for other women and minority groups to see cannabis as an accessible industry. “It’s not just about women, it’s about having people from all different backgrounds to bring different skill-sets and working approaches to the role,” says Sophie. Mala agrees: “In the cannabis industry, if you imagine a patient advocate you imagine a woman, if you imagine an investor, you imagine a man. We’ve already started stereotyping these roles and no one’s challenging this.” Both see the emergence of the cannabis sector as an opportunity to tackle gender stereotypes and challenge perceptions of traditional male and female roles in the workplace and wider society. As well as a chance to show younger generations that cannabis is legitimate business. “There are so many stereotypes we need to batter-down and having serious examples of different people in different roles is going to be the best thing to encourage the next generation to look at this industry as a serious career prospect,” adds Mala. “If you’re going to start something from scratch, why would you create the same thing again? We have an opportunity to reinvent the wheel here.”

The Women in Cannabis Leadership group currently meets every three months via Zoom and is always keen to welcome new members. Contact Mala and Sophie at: mala@ cellenhealth.com and Sophie.Thompson@auroracomms.com

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Cannabis questions answered

Cannabis scientist, Dr Callie Seaman answers common questions relating to the medicinal cannabis market and how pharmaceutical products differ from those found in the wellness industry. What are Terpenoids, Flavonoids and Cannabinoids?

Terpenoids are a class of organic chemicals that include cannabinoids and terpenes. Terpenes are aromatic, volatile compounds that create the smell and flavour of plants but also have medicinal qualities. Cannabinoids are the more widely known about secondary metabolite within cannabis. They include THC, CBD, CBN and many others. Phytocannabinoids are found within plants; they mimic endocannabinoids that are produced within the human body such as Anandamide and 2AG (2-Arachidonoyl Glycerol). Can you eliminate THC from your medicine? THC generates a fair amount of fear for many people, but the reality is it does have medicinal properties. It’s true that it’s what gets you high, inducing a euphoric feeling. But THC isn’t toxic, so you can’t overdose from it although it can produce a very overwhelming sensation. Many strains of cannabis have been bred to have higher levels of CBD and very low levels of THC. Similarly, THC can be removed through the various extraction processes. Isolate vs full plant extract. Maybe the easiest way to explain this is to look at the example of sugar. Sugar beets grow in the ground before being dug up and turned into molasses; a thick, brown solution that contains a mix of all the sugars that can be taken from a sugar beet. This is a ‘full plant extract’ of the sugar beet. Molasses can then be further refined into granulated sugar; the fine white powder we’re used to seeing in the supermarket. This is an isolate; a single compound of sucrose in an ultra-pure form. In what forms are cannabis-based medicines (CBM) available? CBM comes in many forms. ‘Flower’ and ‘floss’ are both names for the dried cannabis flower, which is prescribed across Europe

and North America. This is generally used for pain relief and is smoked or vapourised. Quite often patients prefer a liquid or tablet which they’re more comfortable taking. This can come in the form of tinctures, balms, juicing solutions and concentrated cannabis oil. Similarly, CBM can be formulated into suppositories, cremes and topicals. What’s the difference between cannabis from clinics and online or high-street CBD? All cannabis can be medicinal, but there are diseases that require a high standard of product which is consistent and free from microbes. THC and CBN, being psychotropic, are Schedule 1 drugs that require a doctor’s prescription, so they aren’t available on the wellness market. CBD on the wellness market can often be a hemp oil, missing the breadth of compounds that can be found in pharmaceutical grade products. What are the steps taken to keep products safe for consumption? Aspergillus lives between the cells of a plant. Smoking the plant can introduce it into the lungs, potentially causing lung disease. Testing in a clinical setting can prevent it from getting into the system. E.coli, salmonella and other human pathogenic disease can live in soil, on surfaces and on our hands so the strict cleaning regimes practiced by pharmaceutical facilities help to ensure the cultivation process prevents the spread of these diseases. Other issues found in untested CMB that can be hazardous to human health include heavy metals, pesticides and residual solvents. Dr Callie Seaman is an experienced cannabis scientist and founding director of Aqua Laboratories Limited – a formulator and producer of specialist hydroponic nutrients. She became passionate about medicinal cannabis when she was first diagnosed with epilepsy over 20 years ago.

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