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Why NHS trials won’t help the children relying on medical cannabis now

NHS trials are welcome but we’re not willing to risk our children’s lives, say campaigners

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Why the NHS trials won't help the children relying on medical cannabis now
Dozens of children have been denied a medical cannabis prescription on the NHS.

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Home » Health » Epilepsy » Why NHS trials won’t help the children relying on medical cannabis now

Medical cannabis campaigners have welcomed trials promised by the government this week, but they won’t help the dozens of children who need NHS access now.

Families have welcomed further promises from the government this week of two “pioneering” randomised control trials (RCTs) into the use of cannabis medicines for epilepsy.

Speaking in Parliament on Tuesday 1 March, Minister for Care and Mental Health Gillian Keegan, said the NHS and the National Institute for Health Research (NIHR) were “working closely” on two RCTs to compare the effects of medicines containing CBD, and CBD with THC, and a placebo.

“This is a pioneering area of research and I’m aware that NHS England and NIHR are working closely to get the trial started as soon as possible,” said Keegan, in response to a question brought by Christine Jardine, the Lib Dem MP for Edinburgh West.

Jardine has been pushing for NHS access to medical cannabis on behalf of her constituent, nine-year-old Murray Gray, who has been seizure-free since he was prescribed the medication privately. 

Murray is one of dozens of children who have been denied a prescription on the NHS, leaving their families forced to fundraise to find the hundreds of pounds needed each month to cover the costs. 

“Unethical” trials

Karen Gray, Murray’s mum said the promise of NHS trials was “long overdue” but these trials will not be suitable for children like her son, who are already responding well to whole plant cannabis.

The medicines used in the NHS trials are expected to be isolated CBD and THC products, meaning patients won’t benefit from the other minor cannabinoids and terpenes found in whole plant cannabis, which make up the entourage effect.

To partake in the trials, children would also have to come off the medicines they are currently on and may end up being given a placebo.

Karen fears that Murray’s seizures would return if he stopped taking medical cannabis, which could be life-threatening for him. His condition, Doose syndrome, previously left him suffering hundreds of episodes a day.

“NHS trials are welcomed, and are three years overdue,” said Gray.

“They will hopefully be beneficial for some children who have not tried cannabis medicine, but our children rely on the whole plant oils they have been receiving for the past three years.

“They unfortunately cannot enter into these new trials as they would have to be stripped off their current cannabis oils to perhaps take a placebo. It’s unethical and I would not risk my child’s life like this.”

She added: “We need the NHS doctors to write our prescriptions, they will be writing children prescriptions for THC during the trial,  therefore they should now do the right thing and write our children’s prescriptions also.”

Jardine also recognised that while these trials may help break the current “log jam” when it comes to medical cannabis on the NHS, there is still a way to go before patients like Murray have access to the prescriptions they need.

“We still have a long way to go before we have the sort of NHS support and prescriptions which children like Murray so desperately need and deserve,” she told Cannabis Health.

“For me the significance of the trials is not in its immediate impact but in moving us forward and breaking the log jam which had existed since November 2018.

“We still need to be pushing at every opportunity for NHS prescriptions to be provided for children like Murray whose lives have been transformed.

“We also need to recognise the work that is being done by British companies to establish a viable industry in this country producing medicinal cannabis  oil and the difference that could make for so many people whose lives could be transformed by access to it.”

More questions than answers

Others have raised concerns that these RCTs may result in more questions than answers. 

Matt Hughes, co-founder of Medcan Support, which supports families of children with epilepsy, believes the trials are not due to start until 2023 – five years since the law changed to legalise cannabis – and he believes the studies are too “narrow” in scope.

“There are some question marks over the design of these trials, it seems quite short-sighted and could potentially lead to further delays to access,” said Hughes.  

“Fundamentally the NHS wants to know if THC is any more efficacious in seizure control than CBD. If an isolated THC product is no more beneficial than a CBD isolate, is that going to lead to further delays in accessing it? Is it going to lead to the NHS saying that cannabis shouldn’t be prescribed, when actually they haven’t looked at the full entourage effect?”

He continued: “Even if it is shown that THC is more efficacious, I don’t believe that will lead to the prescribing of the current unlicensed medicines. What we’ll end up with is isolated products available on the NHS, not the whole plant cannabis that is prescribed privately.”

Real-world data

Another issue is the amount of CBD and THC in the products, which Hughes believes will be a 20:1 ratio of CBD to THC.

A recent observational study carried out by Drug Science, analysed the effects of whole plant cannabis extracts in 20 children with refractory epilepsy, and was found to reduce seizure frequency by 86 per cent.

However, the average ratio of CBD to THC was 25:1 to 30:1 – and importantly, researchers think the other minor cannabinoids and terpenes were also having an effect. Tests are currently being carried out on the oils used to quantify the ratios of other cannabinoids that the children were taking.

Hughes wants to see this real-world data being used, to not only help shape clinical trials, but as the evidence itself. 

The trial design isn’t looking at what happens in the real world,” he continued.

“Real world evidence really needs to be taken into consideration here. RCTs are good, but they are a very long and expensive journey, meanwhile patients are left waiting and suffering.

“We could be prescribing cannabis [on the NHS] now, based on the current research and looking at the individual children that have benefited from it.”

Cannabis Health contacted The NIHR but they were not in a position to comment or provide further details.

NHS England and the Department of Health and Social Care had not responded to requests at the time of publication.

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My daughter’s seizures reduced by 95% on medical cannabis – why is it not available on the NHS?

Clover Carkeet’s family have had to fight for her to maintain access to the treatment

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My daughter’s seizures reduced by 95% on medical cannabis
Emily Carkeet with her three-year-old daughter Clover

Three-year-old Clover Carkeet’s seizures have reduced by 95 per cent with medical cannabis – so why has her family had to fight so hard to maintain access to it?

Clover had her first seizure at just 12 weeks old. Doctors diagnosed her with infantile spasms, a ‘catastrophic’ form of epilepsy that is among the most brain-damaging conditions of its kind. 

Early signs of the condition were discovered when her mum, Emily Carkeet, was 30 weeks pregnant. 

She was told that Clover was missing the part of her brain that connects the left hemisphere to the right, known in medicine as the corpus callosum. 

Seventy five per cent of newborns with the condition will grow up to live completely normal lives, but sadly Clover is among the minority that develops neurological issues from early childhood.

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Like many children diagnosed with rare forms of epilepsy, Clover was started on a heavy dose of steroids which she took for six weeks. 

“It was a really awful time for us,” Emily recalls. “They made her extremely poorly. She was so upset and angry. She was basically just staring into space.”

After the steroids, Clover was started on a strong antiepileptic drug called vigabatrin, with her enjoying five months without seizures. The freedom gave her the chance to develop, and even learn to crawl.

My daughter’s seizures reduced by 95% on medical cannabis

Spencer, Emily and Clover Carkeet

Trying CBD

But it wasn’t just the vigabatrin that was aiding her recovery, Emily believes. 

When Clover was four months old, her parents began giving her tiny doses of over-the-counter CBD oil called Hayleigh’s Hope. In the early days of Clover’s diagnosis, Emily had connected with hundreds of families whose children suffered from similar conditions.

“I was always searching for the answers for Clover,” Emily says. 

“I found that the children who were taking some form of CBD all seemed to be developing fairly normally. Their seizures were well controlled and they were spending less time in hospital.”

She continues: “Every time we increased her dose she would learn something new, physically her development was ahead of some of her neurotypical peers, she crawled at nine months and walked at 13 months, all these things that they said she wouldn’t do.”

But after five months Clover relapsed and developed something called focal seizures. Despite increasing her pharmaceuticals, her condition worsened until she was having as many as 100 seizures a week.

95% reduction in seizures

At this point, Emily and her partner, Clover’s father, Spencer, were at a “crossroads”. Either introduce more pharmaceutical medication or pursue a CBD prescription.

“It became abundantly clear that what we could buy over the counter just wasn’t strong enough for her,” Emily says. 

“We were at a crossroads really; we could either add more meds… but we had made a vow in those early days that that was not what we wanted for her. We wanted to give her a chance to have a quality of life, and we believed the best chance of that was by staying as far away from heavy duty drugs as possible. 

“That’s when we decided to go down the prescription route.”

Clover met criteria and was able to access a legal prescription for medical cannabis in August 2020. By November, her seizures had dropped to just three or four per week – a 95 per cent reduction. 

The following April, the family added the THC-containing oil Bedica to Clover’s course of medication, which is when the number of seizures fell “dramatically”.

“THC was the game-changer for her. She was sometimes going 10 days without a seizure,” says Emily.

“The biggest doubt for me was that THC might have detrimental behavioural and developmental effects, it worried me, but less than having her on a benzodiazepine, wired up to machines in hospital. As her mum I’ve always followed my gut instinct.”

My daughter’s seizures reduced by 95% on medical cannabis

Clover’s parents say THC was a “game-changer” for her

Battling the BPNA 

Despite Clover’s parents seeing a huge improvement in her condition and quality of life, the family faced losing her access to the medicine when her prescribing doctor was reported to the General Medical Council (GMC) last year. 

Although she doesn’t know the details of how it came about, the complaint was made shortly after Emily wrote to Clover’s neurologist in the NHS outlining her daughter’s positive response to cannabis-based medicines. 

The complaint, believed to have come from the British Paediatric Neurology Association (BPNA), centred around Clover’s age as at the time, at 17 months old, she was the youngest child in the UK to be prescribed the medicine. It stated that the doctor was not a neurologist and therefore should not be prescribing. 

BPNA guidance claims that cannabis medicines can only be prescribed in children with epilepsy by a paediatric neurologist. But this is not stated anywhere in current legislation. 

The case ended up being dismissed, with the GMC’s independent medical expert quoted during the review as saying the BNPA position is “probably not in the best interests of children”.

“Doctors sign a Hippocratic oath then they don’t do what’s best for their patients. It’s very negligent to deny these kids a medicine that clearly works for them,” says Emily.

“What I don’t understand is this necessity to throw so many drugs at them just because they’re licensed.

“In my opinion – and logic should rule here – if a child finds something that works, why would you then force them to go back and try all these other things that may be detrimental to them? I find this concept of using cannabis as a last resort absolutely crazy.”

Emily believes that the BPNA guidance on medical cannabis is part of the reason why NHS access is so limited for children with epilepsy.

“They complained about Clover and made no effort to speak to me about how she was doing at all. They don’t listen to us as parents, even though, when you’re a parent of a child with epilepsy, you become the expert on their condition,” she says.

“It’s just so wrong on so many levels.”

Emily and Spencer, with Clover, on their wedding day recently

A “constant juggling act” 

Clover is doing well developmentally and starting to communicate more as she reduces her prescription drugs, something Emily puts down to the medical cannabis. 

“I had read about neuroprotective benefits from cannabis and genuinely think that because she’s had it in her life since she was so young, it’s probably protected her brain,” she says. 

“We’ve never seen any regression from any of her seizures and I honestly think it’s the cannabis we have to thank for that.”

She attends nursery and Emily has been able to return to work. Something which has been a lifeline in funding Clover’s prescription, which currently costs around £1,000 a month. 

Emily and Spencer are able to fundraise, but still pay £600 each month out of their own pockets. Emily describes the situation as a “constant juggling act”.

“I feel an extreme pressure to be working more than I am because we have this prescription to pay for,” she says.

“The person who suffers from this is Clover because she doesn’t get as much of her mum as she needs.”

But despite their struggles, Emily feels lucky they have access to the treatment when so many families in the UK are unable to obtain a prescription even privately. 

There is currently only one paediatric neurologist prescribing for children with epilepsy in the UK, and he is not currently taking on any new patients. 

“There are so many parents who are desperately trying to get this medicine, because they see the results,” she adds.

“It’s an injustice that they can’t access it.”

 

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Support secured for Scottish medical cannabis debate on behalf of 9-year-old Cole Thomson

An MSP has secured cross-party support for the first debate of its kind in Scotland.

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Scottish debate secured on behalf of 9-year-old seizure-free thanks to cannabis
Cole Thomson has been seizure-free since 2019

An MSP has secured cross-party support for a members debate on access to medical cannabis, on behalf of nine-year-old Cole Thomson, who relies on the life-saving treatment.

Collette Stevenson MSP for East Kilbride has secured cross-party support after submitting a motion for a members debate on access to medical cannabis for drug-resistant epilepsy.

The motion is now considered eligible for debate, and will be the first of its kind to take place in the Scottish Parliament.

It comes as Ms Stevenson has been supporting the family of Cole Thomson, who has been seizure-free since 2019 thanks to medical cannabis, in their campaign for NHS access. The debate will help highlight the various issues the family has faced in funding the treatment. 

“The first time Cole had a seizure, it was 2012, and he was three and a half months old. He was in my arms, and suddenly his eyes widened like something had come into view. It would have been easy to miss, but as I was already mum to a two-year-old I knew something wasn’t right,” says mum of nine-year-old Cole, Lisa Quarrell, who pays £1,300 a month for her son’s life-saving whole plant cannabis oil prescription.

“Cole’s dad, David, put it down to me being an overprotective mother, but the following day Cole did the same thing again and by the end of the week I managed to film him doing it 10 times. It was obvious something wasn’t right, so I took him to the doctors.”

Every parent’s worst nightmare

After taking blood tests, urine samples and having a thorough check over, Cole’s GP deemed him to be perfectly healthy. That’s when Lisa showed him the video, and his face dropped.

“We were told to go straight to the hospital,” Lisa continues.

“When we got there, the nurse made out like these spasms were totally normal, but when the paediatrician saw it happen she told us it could be West syndrome – a condition where both sides of the brain malfunction. I was terrified.”

Cole was taken to Glasgow Children’s Hospital, where Lisa was given the news that is every parent’s worst nightmare: the best case scenario was that Cole would live, but be severely disabled. 

The worst case was that he would die before he was five-years-old.

“We couldn’t believe it, until a week ago we had a three-and-a-half-month old baby who was perfectly healthy,” says Lisa.

“We were living in a bubble at that stage because when you’ve got a new baby everything is amazing and new. Then ‘boom’ our whole world was turned upside down.”

After four weeks of waiting, desperately trying to not live in the awful reality they were now faced with, Cole’s results came back. He had focal epilepsy, which meant the tissue was damaged on the left side of his brain. 

He was given a two week course of strong steroid medication, in the hope that once he was weaned off, the seizures would stop.

Scottish debate secured on behalf of 9-year-old seizure-free thanks to cannabis

Cole began having seizures at just a few months old

But devastatingly, they became worse. What had been infantile spasms, became full focal seizures. His little body would go rigid, his breathing would become heavy, and he would make repetitive clicking noises until the seizure passed.

From then on, Cole had three to four major seizures a week and was tried on nine different anti-epileptic medications, all of which came with negative side effects, and none of which helped. 

When he was 18 months, Cole’s consultant told Lisa and David that as the drugs weren’t working, brain surgery was the next step.

“Both Cole’s dad and I were against it, but we went for all the meetings and then his seizures suddenly got really bad, so we started the process for brain surgery,” says Lisa

Cole had a left temporal lobe lesionectomy, and had a two centimetre squared area of his brain removed. 

Although he recovered quickly with no side effects, the seizures came back six months later. 

Sadly, this meant that Cole was a candidate for a second brain surgery that would be much more serious. The damage was near his vision and movement and speech. If they cut any more away it could leave him paralysed.

But, in June 2018, everything changed.

Desperate for a solution

“Cole was having 12 seizures a day, his speech was slurred and his walking was affected. The doctors had said there was nothing else they could do. I was desperate,” recounts Lisa. 

“That’s when I put a plea out on social media. I was looking for any solution other than surgery.”

Lisa created a Facebook post asking: “is there anything anywhere in the whole world that you think could help Cole? I don’t care what it is or how much it costs, I’ll do anything I have to to get my boy better.”

Every response came back saying “cannabis”.

Lisa wasn’t convinced. Having been a police officer for a decade until 2013, her understanding of cannabis was extremely negative. 

Scottish debate secured on behalf of 9-year-old seizure-free thanks to cannabis

Cole, before and after cannabis

“I was blindsided, I thought cannabis was a demon,” she admits.

“I remember saying ‘I’m not putting my son on cannabis. It causes psychosis, withdrawal, mental health problems, it’s a gateway drug’ – everything that people who are ill-informed think.”

But then Lisa started to research, not because she wanted to see how good it was, but because she wanted to find evidence to back up what she now knows to be misguided views. 

“I wanted to prove it was nonsense, but anything negative I saw just happened to be a study performed by a pharmaceutical company, a religious group or anti-drug organisations,” she says.

“There was never a scientific view that was against cannabis, it was all very positive.”

In October 2018, Cole took a turn for the worse and began suffering from Todd’s paralysis, a neurological condition in which a seizure is followed by a brief period of temporary paralysis.

“Cole would come out of a seizure and be paralysed. He was confused, unable to sit up, he would wet himself,” says Lisa.

“It would last about an hour at first, then it progressed until he would be paralysed all day. I couldn’t work, I couldn’t take my other son to school, it was like living in a nightmare.” 

That’s when Lisa took the plunge and began treating Cole with an over-the-counter, full-spectrum CBD oil, recommended by the Kalapa Clinic in Barcelona. Within three days the paralysis had completely gone and his seizures decreased from 12 to nine a day.

Seeing such incredible results when all else had failed, made Lisa realise that she had to get a whole plant cannabis oil for Cole. 

“We nearly lost him”

In December 2018, after putting pressure on First Minister, Nicola Sturgeon, Lisa was told Cole’s name had been ‘picked out of a hat’ and he was to be given one of only five prescriptions in Scotland for Epidyolex. 

But Lisa knew he needed the benefits of a whole plant oil, she says: “I didn’t want to move Cole from a whole plant to isolate, but his consultant urged me to try it. He said ‘it’s free, what’s the worst that could happen?’ And I trusted him.”

Lisa weaned Cole off his over-the-counter CBD oil in preparation for switching to Epidyolex. But on the way to hospital to receive his first dose, Cole collapsed. The Todd’s Paralysis was back, and while being treated with Epidyolex, his condition got worse and worse.

“He wasn’t recovering from Todd’s Paralysis, he started having up to 20 seizures a day which is the most he’s ever had and breakthrough seizures during the day. I had to stay off work. He lost the ability to walk, speak and eat,” Lisa says.

In March Cole was rushed into hospital unresponsive.

“We nearly lost him,” says Lisa.

After extensive blood tests, a lumbar puncture, MRI, CT scan and urine tests that came back clear, the doctors told Lisa: “He just has epilepsy, this is just the way it’s going to be. If you continue with this nonsense, this internet propaganda about cannabis medicines, Cole will die. You need to get him in for surgery, now.”

Scottish debate secured on behalf of 9-year-old seizure-free thanks to cannabis

Cole even attends Taekwondo lessons

Finding success with cannabis

Fortunately, just before Cole was rushed into hospital, Lisa had travelled to Holland to access the whole plant cannabis oil, Bedrolite. Then, as so many other parents have been forced to do, she smuggled the oil back to the UK. 

“I brought the Bedrolite into the hospital and told the doctors I was going to give him his cannabis oil,” she says.

“They assumed I meant the legal CBD oil from before, so they said ‘We’ll turn a blind eye to it but we won’t support it.’ I had to give it to him when no one was in the room.”

Lisa gave him his first dose and that night the seizures halved. The following night they halved again. 

Eventually, Lisa found the perfect balance of Bedrolite, combined with another unlicensed drug, funded by the NHS, Dilantin. 

Apart from some breakthrough seizures when his Bedrolite dose was briefly reduced and when Dilantin became unavailable, Cole has remained seizure free since.

Now, he goes to school, rides a bike and even attends Taekwondo lessons. 

But it’s an immense struggle, both emotionally and financially, to raise £1,300 a month for the privilege. 

Lisa and Cole undertake regular fundraising activities, most recently braving a fire walk which raised enough money to keep Cole safe for another six months. 

But beyond that point, until he can access this life-saving medication on the NHS, Cole’s future remains uncertain.

Lisa says she has even written to the Scottish Government, pleading with them to help fund Cole’s medicine until cannabis is more widely available on the NHS. But she was told it was “a misuse of NHS funds” to pay for his private prescription. 

The NHS and the National Institute for Health Research (NIHR) are said to be working on two RCTs to compare the effects of medicines containing isolated CBD, and isolated CBD with THC, and a placebo.

But while trials are welcomed by campaigners, they will not be suitable for children like Cole, who rely on whole plant cannabis.

Lisa wants the Government to consider observational trials alongside RCTs, as well as making funding available for families facing these crippling costs now.

She says: “I am grateful to have Collette onboard, and to her for submitting this motion. This is another first for us and I hope this will highlight our fight again within the Scottish Parliament and show just how broken the current system is.

“I want to be clear though, that clinical trials are of no use to Cole and will not help him or other children currently taking this medicine, as no parent whose child is safe on a medicine, would ever consider taking them off it, risking their life to give data.

“If the Scottish Government is serious about fixing this they would look at observational trials plus clinical trials and put their money where their mouth is and have funding made available immediately.

Lisa adds: “I fear with the government and NHS only focusing on trials, children such as my son who have paved the way for this medicine will be left behind and forgotten. There must be a long term solution for our children too.”
 
Ms Stevenson added: “I’m keen to hold a members’ debate and highlight the various issues Lisa and Cole have faced. Funding for this treatment is incredibly expensive and that of course leaves Lisa and Cole in a difficult situation as they try and raise funds.

“The current Home Office rules only allow certain doctors to prescribe cannabis-based medicinal products but I understand there is a hesitancy for unlicensed products given the lack of clinical trials. I want to see these trials go ahead – supported by the manufacturers, academics and government, so that NHS consultants can have the confidence to consider prescribing this type of treatment.

“Additionally, I’m keen to discuss the calls for a rule change to allow GPs to be able to prescribe unlicensed cannabis-based medicinal products where a non-NHS consultant has initiated that course of treatment. I pledged to do all I could to help Lisa and her family and I am keen to see the necessary changes which would have this resolved once and for all.”

You can donate to Cole’s campaign here 

 

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Experts publish advice on prescribing medical cannabis for epilepsy

UK experts have welcomed the guidance as a “step in the right direction”

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Experts publish advice on prescribing medical cannabis for epilepsy
New guidance has been published for doctors interested in prescribing cannabinoids.

Estimated reading time: 3 minutes

Experts based in Australia, have published new advice for doctors prescribing medical cannabis to patients with epilepsy.

A group of paediatric and adult epilepsy specialists, clinical pharmacists, pharmacologists, and cannabis researchers from across Australia, have published new guidance for doctors interested in prescribing cannabinoids.

While there is considerable interest in using cannabis-based medications to help treat drug resistant epilepsy, to date, clinicians have little guidance on how or when to prescribe these products.

The new advice published in the British Journal of Clinical Pharmacology, aims to provide some initial guidance for doctors on prescribing in the absence of robust clinical evidence.

The document provides an overview of the different cannabis medicines currently available for treating epilepsy in children and adults, with information on dose, drug interactions, toxicity, and type and frequency of symptom and seizure relief. 

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UK insight

UK experts have urged paediatric consultants and members of the British Paediatric Neurology Association (BPNA) to read the guidance, following updated recommendations from the BPNA published in October.

It continues to advise against the prescribing of unlicensed cannabis medicines in children with epilepsy.

The Medical Cannabis Clinicians Society (MCCS) has since published a response claiming the BPNA stance is “unethical” and fails to recognise the “downsides of not prescribing”, which could include a poorer quality of life, brain damage and even death for patients experience severe recurrent seizures. 

Chair of the MCCS Professor Mike Barnes, welcomed the guidance from Australia, which while “still cautious”, is a “step in the right direction”. 

Matt Hughes, co-founder of Medcan Support, an organisation which supports families living with epilepsy in the UK, also recognised that it was “more open” to the prescribing of unlicensed cannabis medicines that what has been published previously.

The consensus advice will be updated as new evidence emerges and will provide the structure for a more definitive guideline in the future.

Senior author Jennifer H. Martin, MBChB, MA, PhD, FRACP, a researcher at the University of Newcastle and director of the Australian Centre for Cannabis Clinical and Research Excellence, commented:  “In the absence of a registration dossier, scientific experiments and case reports are helpful to provide some guidance to optimised dosing. 

“However, as in this guidance, observational data obtained from clinical practice—which often includes information not included in scientific experiments or even early clinical trial data, such as treating patients with other co-morbidities, taking multiple medications, and patient diversity—can be very helpful to clinical practice.”

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