Connect with us
  • ciitech

News

‘Like using a sledgehammer to crack a nut’ – experts respond to new CBD guidance

Published

on

The Food Standards Agency (FSA) has published new guidance for CBD novel food applications – including confirmation that these must include toxicology data.

In the latest guidance for CBD companies ahead of the March 2021 deadline, the FSA has confirmed that novel food applications will not be successful without the inclusion of toxicology safety data.

In February 2020, the UK Food Standards Agency set the deadline for the industry to apply for European Union safety evaluations for “novel food” status.

The new guidance, published on Thursday 24 September, highlights that applicants will need to include ‘details of the toxicological studies they have undertaken, or propose to undertake’ adding that without this it is ‘unlikely we will be able to validate an application’.

The FSA also states that applicants should consult the EFSA’s guidance on ‘the usual application process for all novel foods’, which includes the details of a 90 day rodent safety study.

Only products with this validation will be allowed on the market after 31 March 2021 – but the cost of generating this data is estimated to be between £300,000 and £1million.

The guidance has been welcomed by the Association for Cannabinoid Industry (ACI) which this week announced the launch of its ‘landmark’ safety study with a consortium of CBD companies.

In partnership with Advanced Development and Safety Laboratory (ADSL), the study will address the existing gaps in data identified by the Government Committee on Toxicity (COT)  – including whether CBD causes potential drowsiness, liver toxicity or has any interaction with other drug substances.

It will also provide the safety information mandated by the novel foods application process.

In a statement the ACI said it was ‘leading the way’ for the global CBD industry.

“The safety information generated in this study will respond to future demands of regulatory authorities in the US and EU,” it said, adding that the approach would also minimise animal testing by allowing all the members to use the data from one OECD 408 rodent study, instead of many companies conducting their own.

Steve Moore, strategic counsel for the ACI described it as a ‘transformational’ time for the industry, he commented: “We’re seeing evidence from studies that shows there is a wide variance at the moment in terms of product quality, so it’s very obvious to us that regulation will improve the industry.

He continued: “It is going to be a transformation time for the sector.

“It’s clear that not all the organisations currently operating in this marketplace are going to be able to meet all the regulatory requirements and the industry will be structured very differently this time next year.”

With the cost of generating the toxicology data in the hundreds of thousands of pounds, there is widespread concern that the FSA regulations will drive smaller, ethical CBD companies out of business.

Professor Mike Barnes, head of the Medical Cannabis Clinicians Society, believes we should be promoting a more diverse and ‘dynamic’ industry to boost the economy.

“The CBD industry is in need of regulation. However, the new novel food regulations are like taking the proverbial sledgehammer to crack a nut,” he said

“If implemented as stated it will drive most, if not all, of the small cbd suppliers and retailers out of business and plays into the hands of ‘Big Cannabis’ – those that can afford the huge fees of the ACI for example.”

He added: “In a post-Covid era we should be encouraging a new dynamic industry like the CBD sector, which creates jobs and tax income and provides the consumer with choice.

“The novel food regulations and those who support them are doing the industry no favours.”

Read the latest FSA guidance at www.food.gov.uk/business-guidance/cannabidiol-cbd

Case Studies

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

Published

on

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.”

Continue Reading

Feature

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

Published

on

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

Continue Reading

News

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

Published

on

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.

Continue Reading

Recent Articles


Trending