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‘Failure’ to embrace medical cannabis has caused “preventable deaths” – report

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The ‘failure’ of the medical profession to embrace cannabis-based medicines may have led to preventable deaths, according to experts.

A new paper has highlighted for the first time the ‘inequity’ of a system where parents are forced to pay thousands of pounds a month to keep their children alive, say those behind it.

Research published this week in the journal BMJ Open shows that 20 months after cannabis-based products for medicinal use were legalised in the UK, attitudes towards them remain highly sceptical.

Almost no NHS prescriptions have been issued and less than a hundred have been made available from private providers at a cost of at least £1,000 a month.

As a result, many thousands of UK patients are self-medicating with non-regulated cannabis products for medicinal use.

The lack of access has forced some parents of children with severe epilepsy to travel overseas to get the only treatment which has proven to be effective for their children’s condition, with many spending up to £2,000 a month to keep their children alive.

Speaking to Cannabis Health, Professor David Nutt, lead author of the study and chair of Drug Science, the leading scientific body on drugs in the UK, said: “The whole point of this paper is to highlight the inequity of it.

“These are families whose children have been saved by medical cannabis, but their parent’s lives have been destroyed by having to pay thousands of pounds a month to get treatment to keep their children out of hospital.”

He added: “When the chief medical officer said two years ago that cannabis is a medicine, they were all expecting doctors would be able to prescribe, they have every right to expect the NHS to listen to them.”

Professor Nutt and fellow researchers from Imperial College London, London School of Economics and Drug Science, concluded that the ‘failure’ of the medical and pharmacy professions to embrace cannabis-based medicines is not only a ‘great worry to patients’ but may have led to preventable deaths from conditions such as epilepsy.

“It’s inconceivable that people haven’t died as a result of this,” Professor Nutt continued.

“Three hundred people a year in Britain die from epilepsy, it’s perfectly plausible that some of those would have responded to medical cannabis if it had been offered.”

Researchers consulted with parents, patients, prescribers, pharmacists and decision makers to understand why the UK is lagging behind other countries, despite the potential cost savings to the NHS in terms of reduced hospital stays and less prescribing of other medicines, particularly opioids for chronic pain.

They found a series of barriers to prescribing that needed to be overcome in order to improve patient access, including a perceived lack of scientific evidence.

“NICE will say we need randomised controlled trials, but these children are their own controls, they are the science of this treatment,” argued Professor Nutt.

“Their parents have invested tens of thousands of pounds into their child’s wellbeing because it works. Their lives have been transformed, is that not evidence enough?”

The study also found that resistance to prescribing also stemmed from the fact that for almost 50 years, the medical profession has focused on the risks of cannabis with claims of harms, including male sterility, lung cancer and schizophrenia.

Though these have now been largely debunked and were generally the result of recreational rather than prescribed medical use, researchers suggest that many practitioners may not be aware of this.

Through Project Twenty21, which launched this summer, Drug Science is aiming to monitor the health outcomes of 20,000 medical cannabis patients over the next two years, subsidising the cost of a prescription to up to £150 a month per product.

It aims to create the largest body of evidence in Europe for the efficacy of cannabis-based medicines, while reassuring the medical profession that they are safe.

Around 90 doctors who are interested in prescribing have already signed up, says Professor Nutt.

“The thing that I think would really transform the landscape is if GPs were allowed to prescribe. They tend to be more holistic doctors and are less interested in scientific trials, they just need to know that their patients are getting better,” he added.

“Every doctor must realise that the only real evidence that matters is whether their patient benefits.

“If a patient of yours responds to treatment, as a doctor you should move heaven and earth to make sure they can have that treatment.”

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What are the benefits of CBD?

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The benefits of CBD are wide-ranging, here’s a few of the most common ways people find it helpful – and the evidence to back it up.

Over recent years, as the use of CBD has rocketed in popularity, there seems to be no end of uses that people have discovered for it.

However, the ways in which it can be used are often broken down broadly into a few key categories. Cannabis Health takes a look at some of the most common complaints CBD can be used for.

Pain relief

While the conditions may vary, one thing is clear; CBD is a valuable weapon in the fight against chronic pain.

Anecdotally, it has provided much-needed relief to sufferers of endometriosis, fibromyalgia and arthritis, where previous, prescription-strength medications has failed.

As for the science, in December, a study of Canadian medical cannabis patients found that its use reduced the use of prescription painkillers. 

The research found that, at the start of the six-month study, 28 per cent of participants were using opiate-based painkillers, which dropped to 11 per cent at the end. 

Such findings are also good news for tackling the UK’s increasing addiction crisis; around 540,000 Britons are thought to be addicted to opioids.

It is understood that CBD’s pain-relieving properties stem largely from its anti-inflammatory effects – which is why it is also gaining popularity among athletes and sportspeople. 

Insomnia

Sleep – or the lack of it – is a huge issue, and for many it has only got worse over the past 12 months. Studies suggest than one in four people are struggling to get to or stay asleep, with mothers, key workers and people from minority ethnic backgrounds the worst affected.

While the effect of cannabis on sleeping patterns remains an underdeveloped area of research, it is gaining momentum – with some promising signs.

One study from 2019 showed that levels of cortisol, the stress hormone, reduced significantly in participants who took between 300 and 600mg of CBD oil before bed.

However, another study in the same year found that a more regular dose was needed to improve their ability to fall and stay asleep. After a month on a 25mg dosage of CBD oil, 66.7 percent of patients said their sleep had improved.

Stress and anxiety

We could all do with a stress-reliever from time to time, and too many people still use alcohol or cigarettes for this very purpose.

However, increasing research shows that CBD is a safer and healthier alternative to both of the above, accounting for its rise in popularity amongst the wellness sector.

A landmark study in the US – thought to be the first of its kind – was launched in October last year to investigate CBD’s use as a formal anxiety treatment.

The Cannabinoid Anxiety Relief Education Study is targeting millions of CBD and cannabis users across the US to assess the potential role of cannabinoids in reducing anxiety and other co-morbid conditions, such as insomnia and depression.

And while research still ongoing, preliminary studies also suggest that CBD has been shown to reduce stress in animals such as rats.

Study subjects were observed as having lower behavioural signs of anxiety, and the physiological symptoms of anxiety, such as increased heart rate, also improved.

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Medical cannabis to bring in £3 million annual boost for Isle of Man

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The Island's government recently gave the go-ahead to grow medical cannabis

The medical cannabis sector is expected to generate an additional £3 million a year for the Isle of Man economy after the go ahead was given for cultivation on the island. 

The Isle of Man Government voted to approve regulations to issue licenses for the production, distribution and export of cannabis products from the Island.

The Isle of Man is self-governing jurisdiction and following a series of consultations, its Parliament, Tynwald, approved changes to the Misuse of Drugs Regulations which will permit commercial operators to produce medical cannabis products.

The sector, which is estimated to generate around £3 million in annual benefit in the coming years and considerably more through the growth of associated infrastructure – including financial and operational – to support the sector. 

The Government also expects the medicinal cannabis sector to support and bring innovation to the Isle of Man’s Cleantech and construction sectors, as well as developing businesses from within and off the island. 

The growing global cannabis market provides significant opportunity for economic development in the Isle of Man, with the global market forecasted to account for USD 82.19 billion by 2027.

The new regulatory framework responds to industry and consumer demand for stringent and flexible licensing of a broad range of cannabis products, ranging from outdoor grown industrial hemp to indoor grown medicinal products. 

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.

The Gambling Supervision Commission (GSC) will serve as the launch regulator for the sector and will be issuing guidance for hemp applications from Isle of Man growers soon.

For high-THC operators, the GSC is finalising its approach to its regulation and is consulting with relevant commercial and government stakeholders, and anticipates issuing guidance and accepting license applications in the first quarter of 2021.

Lawrie Hooper MHK, political member with responsibility for Business Isle of Man, said: “We are delighted to launch this exciting new sector in the Isle of Man and to take advantage of the expertise in regulating new, complex industries while providing stringent consumer safety. We’re confident that GSC’s regulation will once again attract quality businesses to the Island transforming the cannabis export sector into a key contributor to the Isle of Man’s post-COVID economic recovery.’

Mark Rutherford, responsible for preparing the new regulatory framework at the GSC, commented: “The Island has a track record as an early adopter of new sectors. Over the course of the past 20 years acting as the regulator for the Island’s eGaming sector, the GSC has developed expertise in keeping the industry crime free, protecting consumers and providing transparency, and this experience is complementary to the skills that will be required for this new and emerging sector.

“This is an exciting opportunity and we have a sophisticated framework for supervising gambling which can be easily adapted to regulate the cultivation and processing of cannabis. We recognise there is huge potential for this new sector to create real positive economic benefit so we need to ensure we treat the new cannabis sector like we have treated the gambling sector: that license stakeholders that are competent, credible and crime free from the outset.”

 

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CBD in Northern Ireland – what you need to know about EFSA novel food applications

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UK FSA novel food regulations no longer apply to Northern Ireland

Northern Irish CBD companies have just ‘days’ to get European novel food applications under way if they have not already. 

Hemp Federation Ireland has urged CBD companies in Northern Ireland to submit their European Food Standards Agency (EFSA) novel food applications imminently, in order to meet the spring deadline. 

While the rest of the UK will fall under Food Standards Authority (FSA) regulations, Northern Ireland must continue to follow EU law after the end of the Brexit transition period. 

As set out in the ‘Northern Ireland Protocol’, any companies seeking authorisation for a CBD product to be placed on the market will have to follow EU and EFSA rules

This is to allow trade to continue uninterrupted between Northern and Southern Ireland.

However, the news has placed CBD companies in Northern Ireland, and those who wish to trade there, in a ‘difficult position’ with just weeks left before the deadline for novel food applications on 31 March.

Hemp Federation Ireland has been advising Northern Irish companies to proceed with the dual application process, allowing them to gain novel food status in both the UK and the EU. 

But those who were not aware of this, or have not already begun the dual application process have now been left at a ‘considerable disadvantage’, Chris Allen, of Hemp Federation Ireland, told Cannabis Health. 

While Northern Ireland is still within UK customs territory it is still subject to the provisions of EU law, including food law.

“This does put companies in a difficult position because the time frame is so tight for applications to EFSA, which I believe will close in mid-February. They really want to have those applications well underway within the next couple of days if they want to be covered by EFSA regulations.

“In reality, there is about a 10 day window for them to get the house in order and when you consider the cost of the novel food application, I can only imagine that there are a lot of companies in the UK scratching their heads now.”

All applications must include 90-day toxicity data, with the cost of this estimated to be between £300,000 and £1million.

Stephen Oliver, of London-based cannabis consultancy firm, The Canna Consultants said it is likely that many companies in Northern Ireland will have already invested in the application process, believing they could remain on the market after this date.

“There is bound to be teething problems arising as a result of Brexit, but this does seem a little bit unfair to companies who didn’t know about it,” continued Allen.

“It does seem that UK and Northern Ireland stakeholders in the industry have been placed at a considerable disadvantage.”

As things stand, CBD brands elsewhere in the UK, will no longer be able to sell their validated products in Northern Ireland after March 2021.

England-based CBD firm Honest Hemp, which sells products in Northern Ireland, said the company was hoping to find a solution. 

“It’s very sad to hear that the CBD companies based in Northern Ireland will now have their products deemed ‘unlawful’, despite going through the same extensive processes as the rest of us in the UK. So, we do feel very lucky to be able to continue operating as an England-based company, said marketing manager, Georgious Mesimeris. 

“Here at Honest Hemp, we are working hard to find a solution that will allow us to continue selling to our customer base in Northern Ireland and ensure their needs are covered. Of course, it’s hard to predict the future in a time like this, but we can keep hoping that things work out for the best eventually.”

Hemp Federation Ireland is working with Irish companies on navigating the post-brexit regulations and is happy to advise on the EFSA application process. 

“The whole industry has been constantly shifting in regulations over the past few years and it’s really not the fault of the companies themselves that they find themselves in this position now,” Allen added.

“There is poor understanding of the regulations in Ireland and that is not something that can continue long term, it will have to be resolved. The really important thing now is for people to know what their options are going forward and to understand how Brexit works from this side of the Irish Sea.”

Allen can be contacted by email on: chris@hempfederationireland.org 

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