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

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

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

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

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

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

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

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

Lorenza Romanese, managing director at EIHA

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

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

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

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

However, Romanese believes that these guidelines are “wrong, old and outdated”.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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New research refutes ‘gateway drug’ fears over cannabis legalisation

Young adults consumed less alcohol, cigarettes and other substances following cannabis legalisation in Washington State.

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New research refutes cannabis as 'gateway drug' theory
Adult-use cannabis has been legal in Washington State since 2012

Young adults consume less alcohol, cigarettes and other substances following cannabis legalisation, according to a new study.

A paper published earlier this month by researchers at the University of Washington, found that young people consumed less alcohol, nicotine, and non-prescribed pain medication, after cannabis was legalised for adult-use. 

Researchers assessed trends in alcohol, nicotine, and non-prescribed pain reliever use among a cohort of over 12,500 young adults (ages 18 to 25) in Washington State following legalisation in 2012.

Contrary to concerns about the detrimental effects on wider society, according to the study, “the implementation of legalised non-medical cannabis coincided with decreases in alcohol and cigarette use and pain reliever misuse.”

The findings show that prevalence of alcohol use, heavy episodic drinking and cigarette use in the past month, as well as prevalence of past-year pain reliever misuse decreased. 

While the prevalence of substance use other than cannabis was “higher among occasional and frequent cannabis users compared to cannabis non-users”, associations between cannabis and pain reliever misuse and heavy episodic drinking “weakened over time”. 

However the team did find that the prevalence of past-month e-cigarette use had increased post-legalisation.

They concluded: “Our findings add to evidence that the legalisation of non-medical cannabis has not led to dramatic increases in the use of alcohol, cigarettes, and non-prescribed opioids.

“The findings indicate that the most critical public health concerns surrounding cannabis legalisation and the evolution of legalised cannabis markets may be specific to cannabis use and related consequences.”

Commenting on the study’s findings, NORML’s Deputy Director Paul Armentano said: “Real-world data from legalisation states disputes longstanding claims that cannabis is some sort of ‘gateway’ substance. In fact, in many instances, cannabis regulation is associated with the decreased use of other substances, including many prescription medications.”

Cannabis legalisation in the UK

Cannabis legalisation is a hot topic in the UK at the moment, following London Mayor Sadiq Khan’s fact-finding trip to LA last week. He subsequently announced that he would be launching a review panel to explore the possibility of decriminalisation in the UK. 

This has sparked debate among politicians, media personalities and the general public alike. 

While Home Secretary Priti Patel shared her thoughts that cannabis can “ruin communities, tear apart families and destroy lives”, Policing Minister Kit Malthouse described it as an “entry level drug”. 

And even Labour refused to get behind Khan, saying the party “does not support changing the law on drugs.”

But recent polling suggests the politicians may be out of touch with the public. YouGov polls show that more than half of Londoners support the mayor’s proposals. 

Meanwhile a poll last year revealed that 52 per cent of the population either ‘strongly supported’ or  ‘tended to support’ legalisation. 

 

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Medical cannabis in the mainstream – the top headlines this week

Get up to date on the week’s headlines.

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Medical cannabis in the mainstream - the top headlines this week

This week the media has been dominated with responses to Sadiq Khan’s controversial fact-finding mission to LA and plans for cannabis decriminalisation.

Although stories of police raids and cannabis farm busts continue to make up the majority of major cannabis headlines, the mainstream media is increasingly covering new developments in the cannabis space, from policy to patient stories.

Over the past few days, MPs have been responding to Sadiq Khan’s controversial trip to LA cultivators and dispensaries, while the Daily Express reported on a new study about a cannabis-based product aiming to treat chronic pain. Here are the week’s five top cannabis headlines not to miss.

The medical cannabis clinic banner

New study into cannabis for chronic pain

Daily Express spoke to the managing director of LVL Health, Tony Samios, about the company’s feasibility study which explores the effects of a cannabis-based product for chronic pain. The study will use cannabis flower in pre-filled cartridges and aims to build the data and evidence needed to improve patient access on the NHS.

Samios told the Express that the study is set to be a “game-changer in bridging the gap between evidence and making change using a rigorous scientific approach” providing “reliable data that is essentially missing”.

Sadiq Khan’s time would be “better spent focusing on knife and drug crime”, says Patel

Priti Patel made her thoughts on Sadiq Khan’s plan to consider cannabis legalisation in London clear in a Twitter post last week.

“Sadiq Khan’s time would be better spent focusing on knife and drug crime in London. The Mayor has no powers to legalise drugs. They ruin communities, tear apart families and destroy lives,” Patel said in the Tweet.

Her rebuke comes after Sadiq Khan’s recent trip to the US which included a fact-finding mission to LA to understand more about an international evidence-based approach to reducing drug-related harm in the capital. The London mayor also announced the launch of a new London Drugs Commission.

Policing Minister Kit Malthouse expressed a similar view to Patel. Last week he told The Sun: “I find it baffling that just last week, the Mayor of London thought it appropriate to stage a photoshoot in a cannabis farm in LA, to reiterate his support for the legalisation of this entry level drug. I profoundly wish he would focus on knife crime and violence taking place in the capital instead.”

Khan initially made his plans clear last year prior to his re-election, saying that he would consider decriminalising cannabis in the capital if he were to be voted in as mayor for a second term.

The Labour party’s response to Khan’s cannabis plan

The likes of Huffington Post, Daily Mail and iNews reported on the Labour party’s response to Sadiq Khan’s plans for cannabis law reform last week.

The party’s stance was made clear in a statement that stated: “Labour does not support changing the law on drugs. Drugs policy is not devolved to mayors and under Labour would continue to be set by national Government.”

HuffPost UK reported that a number of shadow cabinet members were “furious” at Khan’s comments, including Yvette Cooper. “Yvette is furious about it,” a Labour source told HuffPost UK. “People are just rolling their eyes because it definitely is not the official party line.”

Although it goes against his party’s official stance, Khan’s plan reflects data gathered by YouGov which has found that the majority of UK citizens are in support of cannabis legalisation.

Another source told the online outlet: “Sadiq has positioned himself as a progressive mayor on the side of the public prepared to take on the tough questions to genuinely tackle crime rather than pointless posturing that isn’t even popular anyway.”

Meanwhile, iNews reported that Labour MPs “let rip” in a private WhatsApp group. “This is going to go down like a bucket of cold sick in my bit of the suburbs just now… Crime up, police numbers still way below where people think they should be, so Labour is going to have a chat about drugs… Inspired,” said Gareth Thomas, the Shadow International Trade minister.

Not all Labour MPs have responded negatively, however. The Daily Mail reported on Shadow Cabinet minister Ed Miliband’s response to Khan’s plans. Although he highlighted that Khan did not reflect the Party’s position, he said Labour “welcome[s] Sadiq looking at these issues because this debate should carry on”.

“Cannabis ruins lives and legalising it won’t help”

In response to Sadiq Khan’s US visit, journalist and campaigner Louise Perry offered her opinion in an article for the London Evening Standard. While she said she would be “happy” to see possession of small amounts of cannabis made legal, but added that legalising the cannabis industry is “another matter entirely”.

The article is unlikely to sit well with cannabis campaigners and advocates thanks to its comparison between cannabis and tobacco, a focus on the dangers of psychosis and the lack of attention given to studies showing the positive effects of cannabis on health and wellbeing.

“Industries employ lobbyists to disguise the harmful effects of the products they sell,” Perry writes. “This has happened many times before.

“By the early 50s, the scientific evidence was clear: tobacco was killing people. And yet it would be 20 years until warning signs appeared on the side of cigarette packets sold in the UK. This tardiness was the result of lobbying by the tobacco industry, which opposed health authorities every step of the way.”

Patient faces dispute with council over housing

A man living in Norwich who holds a private cannabis prescription says he is facing difficulties finding a new place to live after being told by the city council to disclose his indoor cannabis use to landlords.

As reported by Norwich Evening News, Danny Wilson is prescribed legal cannabis by TMCC Medical Clinic for chronic pain, ADHD and anxiety. Wilson – who is currently on universal credit and personal independence payments due to his condition – pays between £700 and £1,000 per month for his medication.

Mr Wilson said: “I’ve repeatedly told them forcing me to go around approaching landlords and agents this way is causing me trauma but they ignored me.”

Despite never having being in prison, the city council offered him a place at House of Genesis, a rehoming initiative for ex-offenders.

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Medical cannabis in the mainstream – the UK’s top stories

All your cannabis news in one place

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There has been a mix of cannabis-related stories in the media over the past week. In case you missed them, we’ve compiled some of the headlines.

This week, news outlets such as The Guardian and The Telegraph have reported on UK medical cannabis labs, cannabis use for fibromyalgia and a rise in drug-driving cases amongst medical consumers.

Inside one of the UK’s first medical cannabis labs

The Guardian’s Julia Kollewe visited a growing lab owned by Celadon Pharmaceuticals, one of the first cultivation sites to be granted a home office licence to grow high-THC medical cannabis in the UK. The site is based in the West Midlands and grows cannabis predominantly for chronic pain. It is one of the only cannabis cultivators in the country to use an indoor lab rather than greenhouses.

According to The Guardian, Celadon is planning to ramp up production, aiming to grow 10 to 15 tonnes a year and supply up to 50,000 patients. At full capacity, the lab could generate £90m in annual revenues.

Founder James Short said: “I speak to patients on a regular basis who can’t work and are in terrible pain each day, that don’t want to be on opioids. Some are having to pay hundreds of pounds each month for medicinal cannabis. It really does work.”

US research programme studies cannabinoids in ovarian cancer

“Massive injustice” – medical cannabis patients facing driving offences

In a less positive story, The Telegraph reported that medicinal cannabis patients are increasingly being prosecuted for drug driving with arrests reportedly doubling in the last four years.

Those taking cannabis may face a positive result in police roadside testing up to 72 hours after taking the drug. Although studies have shown driving capabilities are not impaired after this length of time, patients still face prosecution.

Since 2016, arrests linked with drug driving have increased by 140 per cent, according to police figures obtained by The Telegraph.

But while medical cannabis patients are at risk of arrest, those taking opiate-based prescription drugs are permitted to drive even if they are over the lawful limit, provided they follow their doctor’s advice.

The Telegraph spoke to one patient, David Dancy, who was being prosecuted for drug driving despite the fact he had taken his prescription 12 hours prior to getting in his car. The 33-year-old said the prosecution is “a massive injustice”.

Fibromyalgia and arthritis patient on how cannabis changed her life

Andrea Wright, a medical cannabis patient from Bristol, spoke to The Guardian about her ongoing battle with psoriatic arthritis and fibromyalgia. The 39-year-old was diagnosed in 2016, suffering from constant pain and severe lack of sleep. She eventually was forced to leave her job due to her ill health.

“I had to stop work because the pain was too much. It’s been very depressing; I really enjoyed my job. I tried so many different therapies and managed to get my arthritis under control but for fibromyalgia, there isn’t anything, no magical pill,” Wright told The Guardian.

After trying medical cannabis as part of a study run by LVL Health, she found she was able to get her first “proper night’s sleep” since 2012. She is now back at work and now aiming to reduce her reliance on opioid painkillers.

300 campaigners march through streets of Cardiff

Campaigners calling for the legalisation of cannabis in the UK marched through Cardiff city centre this weekend, WalesOnline reported on Saturday (7 May).  This was the first protest to take place in Wales since before the pandemic.

The march was organised by Terry Wakefield, who has been involved in cannabis campaigning since 1999. She told WalesOnline that the stigma surrounding cannabis was pushing the trade further underground.

“Cannabis is my medicine. I suffer complex PTSD and this march might sometimes be the only time I’m outside,” she said. “If I was in a position where I could go to my GP and ask for a prescription I would do.

“If we are able to consume cannabis in the UK then we should have a right to grow our own. The more this stays illegal the more it will be pushed underground and the more gangs and slaves in Britain.”

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