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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However, Romanese believes that these guidelines are “wrong, old and outdated”.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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Ireland to fund patient’s medical cannabis up front

Campaigner Vera Twomey described “relief” that her determination has finally paid off.

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Ava Barry medical cannabis patient
Vera Twomey's daughter, Ava Barry has a severe from of epilepsy which is helped by medical cannabis

Campaigner Vera Twomey has described her “relief” as the Irish Government agrees to fund medical cannabis patient’s prescriptions up front.

Eligible medical cannabis patients in Ireland will now have their medication paid for up front, after months of pressure on the Government from campaigners. 

Health Minister Stephen Donnelly announced on Monday 19 July that the refund system for patients who obtain their prescribed cannabis-based products from the Netherlands, will now be replaced by a direct payment system.

The HSE will pay the dispensing pharmacy in the Netherlands directly, rather than the burden falling to the patients and their families, who were then required to apply for a refund.

Vera Twomey, whose daughter Ava Barry, 11, has a severe form of epilepsy known as Dravet syndrome, is among 40 patients who have now been granted an individual ministerial licence to import Bedrocan oil to Ireland.

But the family were paying 10,000 Euros up front every three months for Ava’s prescription and waiting up to five weeks for it to be refunded.

Campaigner Vera Twomey is “delighted” by the news

Twomey, who has four other children, has previously spoken of the huge financial strain this system placed on her family.

Over the last 16 months she has relentlessly called for action, making dozens of phone calls daily to politicians and lobbying ministers on social media with the backing of thousands of supporters in Ireland and across the world.

Twomey, who received a phone call from Ireland’s Prime Minister, Micheál Martin on Monday confirming the news, says she is “delighted” that her determination has finally paid off.

“There’s a sense of relief that we have accomplished this, but also a little bit of shock because we have been trying to resolve it for so long,” she told Cannabis Health.

Twomey’s activism gained national attention in 2017 when she walked from her home in Cork to Leinster House in Dublin to ask former Health Minister Simon Harris to grant access to medical cannabis for her daughter. 

Initially having to travel to the Netherlands to collect the prescription herself, during the pandemic Twomey successfully campaigned to secure the permanent delivery of Bedrocan oils for Ava and other patients.

Now she says she is looking forward to focusing on her family and putting the phone down for a while.

“I don’t think anybody who has gone through this fight, seeing the injustice that we have had to deal with could ever walk away,” she said.

“But at the same time, I’ve made a lot of sacrifices and for the moment at least, I need to give 100 percent to my other children, to do normal things and be a family.”

But the fight in Ireland isn’t over.

The Irish Government announced the provision of funding for the Medical Cannabis Access Programme (MCAP) in January – almost two years after it was introduced – but only four low dose cannabis-based medicines are covered by the programme, for people living with one of three qualifying conditions.

“There are other issues – we still need expansion and improvement in medical cannabis access, the journey is over by any means, but we’re at the beginning and getting Bedrocan recognised as a medicine that is funded up front is very important.

“I think the Irish are actually miles ahead of the British on this one and I hope [politicians] will take notice and catch up.” 

She added: “The greatest gift you’ll ever receive is to lose your fear, then you can accomplish anything with focus and determination.

“If you have the determination to keep going you will get there. It’s not going to be easy, they are not going to make it easy but it can be done.”

Patients eligible for the direct payment system are those suffering from one of three stated conditions; spasticity associated with multiple sclerosis, intractable nausea and vomiting associated with chemotherapy and severe, refractory (treatment-resistant) epilepsy. 

The HSE says it will be contacting patients directly.

Health Minister, Mr Donnelly, commented: “I am delighted that the HSE and Transvaal Apotheek in the Netherlands are implementing a new process which will give peace of mind to the seventeen patients and their families who until now have been using the refund process.”

 

 

 

 

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Kanabo’s cannabis vaporiser for metered dosing launches in UK

The VapePod will give thousands of UK patients access to pain relief in a metered dose.

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Kanabo cannabis Vapepod
The VapePod can administer a measured dose of cannabis extract

Cannabis company Kanabo’s new extract formula and vaporiser will give thousands of UK patients access to pain relief in a metered dose.

UK patients will be the first in Europe to have access to Kanabo’s vaporiser, the VapePod, and its new extract formula when is it delivered later this month.

The deal, in conjunction with LYPHE Group, will see patient’s of LYPHE Group’s ecosystem, including The Medical Cannabis Clinic and Dispensary Green, able to access the VapePod under the brand name NOIDECS.

Under the agreement, PharmaCann and Kanabo established a customised production line for Kanabo’s VapePods cartridges.

An alternative to cannabis flower

The VapePod is a medical-grade, handheld vaporiser which enables accurate and precise micro doses of cannabis extract, dispensing 1mg of formula for each inhalation.

This will benefit to patients as inhaling extracts rather than tinctures and oils allows for faster onset and higher bioavailability.

It will also allow clinicians to more confidently prescribe and monitor a patient’s dosage, as well as providing more accurate patient data.

Previously, cannabis patients in the UK have only been able to access medical cannabis dry flower and oil tinctures for which the majority of patients consume via inhalation due to fast onset time.

Kanabo’s medical line aims to enable patients to move away from the harmful act of smoking medical cannabis flowers as they can now take their medicine without inhaling soot, tar and carcinogens into the lungs.

Kanabo founder, Avihu Tamir

Avihu Tamir, Kanabo’s CEO, said: “The VapePod is a world first allowing specialist consultants to prescribe a metered dose of medicinal cannabis that is healthier for patients than the alternative, which is typically smoking.

“Medical cannabis is a safer alternative to the conventional opiate solutions and other pain management treatments. This announcement ensures that thousands of UK patients have access to the most effective medicinal cannabis delivery system.

“The fact that the VapePod gives exactly 1mg on every inhalation is crucial for GPs because they can prescribe an exact dose which they haven’t been able to do before. For patients who want the similarity to smoking but know they are not inhaling soot and tar. There’s also the bioavailability factor too.

“The reason GPs haven’t been prescribing is the issue of dosing and flowers – they don’t feel comfortable asking patients to smoke. With Kanabo, they can prescribe exact dosing in a safe and consistent way.”

The medical extract formula, which is based on the Israeli medical cannabis pharmacopoeia as a recommendation for the treatment of pain management, has a purity of 70 percent THC with 15 percent minor cannabinoids and terpenes.

Earlier this year Kanabo became the second cannabis company to list on the London Stock Exchange.

Dean Friday, LYPHE’s CEO commented: “Kanabo are experts in novel delivery with their VapePod greatly improving onset times, and for our chronic pain patients we now have an alternative to flower vaporisation. This is the start of a revolution in medical cannabis application and we are delighted to be supplying it under the NOIDECS brand.”

 

 

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Mental health

Cancer survivors turn to cannabis for physical and mental health – study

Cancer survivors are more likely to use cannabis to help pain, anxiety, sleep and nausea. 

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cancer
Cancer survivors are more likely to use cannabis to help pain, anxiety, sleep and nausea. 

Cancer survivors are frequently using cannabis to manage physical and mental health symptoms, says a new study.

Research from the US indicates that cancer survivors are more likely to use cannabis for symptoms such as pain, anxiety, trouble sleeping and nausea. 

A team of investigators analysed results from a Covid-19 cannabis health study to examine changes to cannabis use, methods of cannabis delivery, and coping strategies among cancer survivors since the pandemic.

They found that individuals with a history of cancer are more likely to report cannabis use to manage mental health and pain symptoms.

This group of people were also more likely to report fear of a Covid-19 diagnosis, compared to adults without a history of cancer.

Data was collected from 158 responses between 21 March 2020 and 23 March 2021, from cancer survivors who identified as medicinal cannabis users.

These were then compared to medicinal cannabis users without a history of cancer of the same age.

According to the study, cancer survivors were more likely to report using cannabis as a way of managing nausea/vomiting, headaches or migraines, seizures, sleep problems or as an appetite stimulant.

Specifically, self-reported symptoms most frequently managed by medicinal cannabis among respondents included anxiety and pain. 

Sixty one percent of respondents with a history of cancer used cannabis to manage anxiety symptoms and 54 percent for chronic pain.

Forty eight percent said they used it to manage depressive symptoms and 25 percent for PTSD, while smaller numbers used it for symptoms of another autoimmune disease, and irritable bowel syndrome. 

While there were no differences in how often they used cannabis or their method of administration, cancer survivors were “more likely to have an advanced supply of cannabis”. 

The findings support the need for more conversations between doctors and their patients about the use of cannabis, say those behind the study.

The authors concluded: “Overall, we observed that cancer survivors are frequently reporting the use of cannabis to manage both physical and mental health symptoms associated with their cancer diagnosis and that cancer survivors are more likely to report fear of a Covid-19 diagnosis compared to those without a history of cancer. 

“Given the frequency of mental and physical health symptoms reported among cancer survivors during the Covid-19 pandemic period, clinician–patient interactions should include questions around cannabis use, particularly those with a history of cancer.”

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