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Gut health and CBD – study

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CBD can alter the human gut, researchers have found, but they don’t yet know if these changes are beneficial or damaging to our long-term health.

The human gut is a complex part of the human body, and researchers are only just starting to uncover how much it affects human health.

Numerous studies, however, have demonstrated that a gut with a diverse variety of bacteria is associated with a healthier heart and lower risk of diseases, including diabetes type 2.

The bacteria in our guts is affected by many variants, including our diet, levels of exercise, even the air we breathe.

But despite CBD’s popularity, a group of researchers from the University of Arkansas say there’s very little research on its safety for long-term human ingestion.

‘Recent product quality surveys imply that CBD exposure from commercially available dosage forms may either be enhanced or lessened due to discrepancies between product label claims and actual CBD content,’ their paper states.

‘In addition, several phytocannabinoids have been shown to possess potent antibacterial properties.

Taken together, these elements prompted us to investigate the effects of prolonged CRCE administration on gut toxicology and ecology.’

The researchers set out to determine how CBD may affect our guts, and in turn, our general health.

They gave doses of CBD-rich cannabis extracts to mice in sesame oil, and found that it affected the mice’s guts.

Specifically, it led to a decline in the bacterial species, A. finegoldii, which is associated with several fermentation processes in the human gut, across all groups of mice.

This raises concerns, the researchers state, for the potential untoward effects CBD might have on the gut microbiome.

This is especially concerning for patients receiving CBD as a treatment, they add, since clinical doses are around four times higher than the doses used in this study.

Reductions in gut bacteria diversity, coupled with significant increases in A. muciniphila, which is considered a probiotic, might have negative repercussions for gut health, they write, as declines in this bacteria have been reported in patients with obesity and diabetes.

The paper, ‘Potential probiotic or trigger of gut inflammation’,published in the new issue of the Journal of Dietary Supplements, titled ‘Cannabidiol and Other Cannabinoids: From Toxicology and Pharmacology to Development of a Regulatory Pathway’, states that CBD causes ‘complex’ responses in the gut microbiome

But these consequences, they add, may be favourable or detrimental.

Increases of A. muciniphila can be considered beneficial, but on the other hand, increases in A. muciniphila are at the expense of other bacterial species.

The researchers also noticed several pro-inflammatory responses in the mice, which they say raises concerns about the potential long-term effects of CBD on human health.

Case Studies

‘NHS asking children to come off meds for clinical trials could kill them’

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Parents have warned that ‘washing out’ their children’s medication to enter into clinical trials could put their lives at risk.

The parents of children with severe, life-threatening epilepsy say that insisting that they come off their medication to take part in NHS trials is ‘unethical’.

It comes after the Department of Health appears to have reversed its position on observational trials, insisting that randomised control trials (RCTs) are held before medical cannabis is made more widely available on the NHS.

Following a review into the lack of access held by the Government department last year, the NHS proposed two RCTs and an observational study.

This would take into account the cases such as eight-year-old Murray Gray, who has been seizure-free for 17 months since taking medical cannabis.

A programme of two randomised controlled clinical trials is now being developed by the National Institute for Health Research, with ministers insisting this is the ‘best course of action’ to build evidence.

These trials would require participants to undergo a ‘washing out’ period beforehand, during which they would have to come off their current medication.

Joanne Griffiths, whose son Ben, 11, has treatment-resistant epilepsy has seen his condition improve significantly since he obtained a private prescription last year.

However, her local NHS trust and leading children’s hospital, Alder Hey Children’s NHS Foundation Trust, refuses to prescribe the medication until these trials have been carried out.

During a meeting last year lead neurologists and hospital bosses said they were ‘keen’ to be involved in upcoming trials.

However, Joanne was told that Ben and other children who have already had access to THC products, will be offered a ‘wash out’ period to be eligible for the study.

“Asking these children to wash out their current medicines could kill them, it’s putting their life at risk,” said Joanne.

When Ben was on epidiolex – a drug containing CBD which is prescribed for severe epilepsy – he was having up to 300 seizures a day and was ‘near death’.

“I wouldn’t swap my child from something that is working to something that possibly won’t,” she continued.

“It’s unethical what they are asking us to do.

“We’ve managed to reduce every single one of Ben’s antiepileptic drugs that were not working to control his hundreds of seizures. The only thing that is stopping him having seizures right now is cannabis, if we were to remove that from his system he could go back to having hundreds of seizures and could die.”

Elaine Levy’s daughter Fallon, 26, has been taking medical cannabis since 2018. She saw an instant deterioration in her condition when she tried a cheaper oil to help manage the costs.

“Taking these kids off their medicine they could end up being blue-lighted to hospital, they could die or they might just go back to smashing their head against the floor again,” said Elaine.

“They can’t do that to these children and young adults whose lives have been changed so dramatically thanks to medical cannabis.”

She added: “The whole thing is just astonishing, it’s just the hippocratic oath. You can’t take a person off of something that is working for them and then give them a placebo instead.”

More than 30 cross-party MPs have now signed a letter to Health Secretary Matt Hancock calling for him to release emergency funding to help families cover the costs of prescriptions until they become available on the NHS.

A spokesperson for Alder Hey Children’s NHS Foundation Trust said they could not comment on individual cases.

They said: “Alder Hey is at the forefront for children’s health research and is a founding partner of the NIHR Clinical Research Network for Children. The Trust will continue to engage in supporting any new, well designed and robust clinical trials that investigate the role of cannabis-based medicinal products in drug resistant paediatric epilepsy.

“All studies take into account safety considerations for all potential recruitment candidates and the safety of all patients remains paramount.”

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First Medical Cannabis Awareness Week launches in the UK – how you can get involved

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The first Medical Cannabis Awareness Week is calling for access to NHS prescriptions two years on from the landmark law change.

Taking place from 1-8 November 2020 the inaugural Medical Cannabis Awareness Week (MCAW) will bring together patients, doctors, advocates and organisations to call for fair access to medical cannabis on the NHS.

On 1 November 2018, the law changed to allow UK patients access to medical cannabis. But since then, only a handful of prescriptions have been issued by the NHS.

Patients are struggling to fund private prescriptions – costing several hundreds of pounds a month – and up to 1.4 million people are forced to turn to the illegal cannabis market.

Most patients prescribed medical cannabis live with chronic pain, neurological or psychiatric conditions, such as fibromyalgia, multiple sclerosis, epilepsy, anxiety & PTSD – yet many continue to face stigma in their day-to-day lives and from healthcare professionals when trying to access this treatment.

Launched by PLEA (Patient-Led Engagement for Access) – a community of medical cannabis patients and advocates – throughout the week patients from across the UK will share their stories about the life-changing impact of medical cannabis and their difficulties in accessing a prescription.

Individuals and organisations from across the sector will take part in online events including a tour of a legal cannabis growing facility, and conversations with patients and doctors.

PLEA advocacy director Lucy Stafford took addictive opiate-based painkillers nearly every day of her teenage years to cope with the debilitating symptoms of the connective tissue disorder called Ehlers Danlos Syndrome.

“I had to drop out of school and live with the horrendous side effects. I was a shadow of myself,” she said.

“When I was prescribed medical cannabis, it changed everything. I’ve learnt to walk after years using a wheelchair and now attend university – I’ve got my life back. All patients in need should have the same chance to live a better quality of life – we need NHS access.”

The PLEA Community will host MCAW during the first week of November each year.

As part of the awareness week, people are encouraged to talk about medical cannabis with  their friends and family, record and share their own story, write to their MPs and even play medical cannabis bingo (have you been called a stoner when talking about your medicine? Has anyone ever suggested you’re just after a legal high?)

“It’s time to end the inequality and ensure everyone who needs it has the opportunity to benefit from medical cannabis treatment,” said Abby Hughes, PLEA outreach director.

“During MCAW, we’re calling for fair access, we’re promoting medical cannabis education for all and we’re directly addressing the stigma faced by patients. We want people to have conversations about cannabis, ask questions and be open-minded.

“Cannabis medicines are changing people’s lives around the world. In the UK, people are forced to pay privately, and it’s not right. Medical cannabis is keeping children with severe forms of epilepsy alive, and it’s allowing people with chronic illnesses and conditions to live normal lives.”

PLEA advocates for quality of life with medical cannabis, enabling patients to access their medicine free from stigma, geographical inconsistencies, and financial barriers and supports research into the safety and efficacy of cannabis-based medicinal products, to enable evidence-based prescription for all.

Dr Mala Mawkin, head of market development at Cellen Health and advisory board member at PLEA added: “Even though doctors have been able to prescribe Cannabis based Medicinal Products since 2018, healthcare professionals are still not equipped with the knowledge and tools to prescribe in the UK.

“We have made huge progress to be able to have pharmaceutical-grade THC/CBD medicines for patients that are cheaper and safer than the illicit market. The next steps are to invest in research, medical education and address the stigma faced by patients.

“Events during MCAW are here to show patients and healthcare professionals it is essential to talk openly about medical cannabis to address the unmet clinical needs of people living with chronic conditions.”

You can join advocates and organisations to share your PLEA on social media using the hashtag #MCAW2020

Follow @PLEA_community on Twitter and Instagram.

For more information and full programme visit www.medicalcannabisweek.org.uk

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How Europe’s first medical cannabis tracking app could revolutionise care

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An innovative medical cannabis app has launched in the UK and it’s putting patients front and centre of their care.

Launching on Tuesday 27 October, Eva is a new platform to help patients consuming cannabinoid medications manage their symptoms and capture critical data on the safety and effectiveness of medical cannabis.

The app has been developed by digital therapeutics company Alta Flora and allows patients to record symptoms, medication consumption and quality of life through their phone.

It includes features for patients to add and track symptom severity and medication use –  with functionality for multiple symptoms and medicine routes of administration, such as dose and formulation.

It also allows users to explore trends through interactive tools and assess their quality of life using validated scales and questionnaires, with a clinically valid framework used by NICE (National Institute for Care and Excellence).

It has been designed for use by all patients, however they access their medication.

Alta Flora’s research found a range of challenges facing patients considering medical cannabis as a treatment, including a lack of data of medical cannabis products, stigmatisation within the healthcare system and a lack of access to prescribers and products.

Commenting on the launch, Gavin Sathianathan, CEO and founder of Alta Flora, said: “It has been two years since cannabis was made legal for medical purposes in the UK and since

then, access to these life-changing medicines for patients has barely improved.

“This failure largely rests on a lack of data, the absence of which deprives doctors and

clinicians of the confidence to prescribe it as a treatment.”

Gavin told Cannabis Health that patients who were tracking their symptoms and consumption were then able to have more open discussions about cannabis with their doctors.

“The nature of cannabis medicines means that the patient is required to listen to their own body –  it’s not a standardised thing that you can just get from a doctor, it requires patient-centric tools for us to understand and that’s what we are trying to build,” he said.

“Those patients who took that data to their clinicians found they were engaging with their doctors in a way that was educating them and they were able to have less stigmatised conversations.”

Eva also includes tools for researchers to organise studies within their organisation, such as clinics who want to capture data on their own patients.

“The future of healthcare is patient-centric care. The voice of the patient is becoming much more important, they have a seat at the table now,” he said.

According to Gavin the evidence base produced by Eva will serve both patient and industry needs and could play a key role in providing much-needed data for the safety and efficacy of products, ensuring wider acceptance of medical cannabis.

“We’ve got some really motivated patients who often, after trying lots of different medicines have found that cannabis does work and want to contribute data to improve access for patients in the UK,” he continued.

“We’ve got an opportunity to build a data set to help clinics, prescribers and regulators, understand the impact of cannabis on patients symptoms and quality of life in a lot more detail.”

Gavin also hopes the platform could also be used to track the effectiveness of CBD products on pain, anxiety and sleep,

But Eva’s potential expands beyond cannabis – particularly in a post-pandemic era, he says.

“When we shared what we were doing with academics and researchers it became clear that this idea of instrumenting in real-time the consumption of medicines is valid beyond cannabis,” Gavin added.

“In a post-COVID context, we’re thinking much more about preventative medicine and staying well.

“We’ve had enquiries from the psychedelic space and for monitoring medication used to treat conditions such as diabetes and ADHD.”

Academics from leading UK charity Drug Science have played a role in design, and content from a range of organisations including the Medical Cannabis Clinicians Society, Primary Care

Cannabis Network, MedCannID, PLEA, and CPASS is integrated into Eva.

The service is fully GDPR compliant and will include patient safety monitoring features

and real-time reporting dashboards for clinicians.

Eva is available to download on the Android store. The iOS version will be available from early December.

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