Cannabis medication for epileptic girl costs £1k a month
Emily Howis and Spencer Carret said the treatment has reduced their daughter Clover's seizures from 80 a week to just one.
The family, from Trowbridge in Wiltshire, are importing cannabis oil from The Netherlands.
The government said cannabis-based medicine use was being limited due to "ongoing concerns".
Clover was born with part of her brain missing – known as aicardi syndrome. The genetic condition meant the first three months of her life were blighted by regular epileptic fits.
Mr Carret said she was having "70 to 100" fits a week.
When she was four months old, Clover's parents paid for an over-the-counter CBD cannabis oil.
Now she has one seizure a week on average, and some weeks none at all, they said.
The couple said it was "incredible" how her life has changed, and that their own neurologist was amazed at her progress.
"They weren't expecting her to be able to walk or talk, or do anything really," Mr Carret said.
In 2018, the government said specialist doctors could legally prescribe cannabis oil for medicinal use.
But campaigners said only a handful of families have been successful in the process.
When Clover's parents applied, they were rejected, so their best hope is for her to be included in a medical research trial.
Family and friends are currently fundraising to help pay for the treatment. Friend Lee Evans is doing a 100,000km (62,000 mile) sponsored run.
But like some other families, the couple said they were worried that restrictions caused by Brexit mean they may soon no longer be able to import cannabis oil from The Netherlands.
The Department of Health said several professional medical bodies "remain concerned" about the lack of evidence around the safety and success of cannabis-based medical products.
A spokesman said: "The NHS is working with the National Institute for Health Research and others to build a high-quality evidence base to determine if patients with refractory epilepsy could benefit from these products."
NICE, the body that issues prescription guidelines, updated its advice on cannabis-related medical products in March 2021.
The body said it does not want to ban doctors from prescribing medical cannabis to severely epileptic children as this would restrict research, but has stopped short of recommending CBD oils as a widespread treatment for childhood epilepsy.
Cannabis plants are made up of more than 100 different cannabinoids, which have different impacts on the body and are concentrated to different extents in certain parts of the plant.
The most well-known of these are THC and CBD.
THC is the psychoactive cannabinoid – the one that recreational users use to get "high". CBD does not have this effect.
While almost all cannabinoids are controlled substances under the Misuse of Drugs Act, CBD – or cannabidiol as it is also known – is not.
Whole-plant Cannabis Linked to Large Reduction in Seizures
Whole-plant cannabis is linked to a significant reduction in seizures in children with severe treatment-resistant epilepsy, early research suggests.
In a small case series, children with severe treatment-resistant epilepsy treated with a range of whole-plant extract cannabis-based medical products (CBMPs) reported an 86% reduction in monthly seizures.
All participants had no improvement with traditional antiepileptic drugs (AEDs).
The study adds to a small but growing body of research investigating whole-plant cannabis medicines containing tetrahydrocannabinol (THC) in pediatric epilepsies.
Rayyan Raja Zafar
“Although we have previously noted the superior efficacy of whole-plant medical cannabis is a previous group of children, to find that the effect of the treatment resulted in an 86% average reduction in seizures is remarkable and testament to the clear clinical value of this intervention,” lead author Rayyan Raja Zafar, a doctoral student with the Centre for Psychedelic Research and Neuropsychopharmacology, Imperial College London, United Kingdom, told Medscape Medical News.
The findings were published online December 14 in BMJ Paediatrics Open.
Superior to CBD?
The retrospective case series included 10 children under age 18 years who were recruited through MedCann Support and End Our Pain, charities that represent children who use medical cannabis to treat intractable epilepsies. Data were collected from patients’ parents or caregivers between January and May 2021.
Patients presented with a range of epilepsy etiologies and reported a mean of 7 (±4.58) AEDs prior to initiation of CBMPs. Two patients experienced no symptom improvement after taking Epidyolex, a purified cannabidiol (CBD) approved by the European Commission in 2019 for the treatment of rare forms of epilepsy. The formulation was approved by the US Food and Drug Administration in 2018 under the name Epidiolex.
All participants received CBMPs, including Bedrolite (<1% THC and 9% CBD), Bedica (14% THC and <1% CBD), Celixir 20 (<1% THC and 20% CBD), Sweet Pink CBD (<1% THC and 10.6% CBD), and Althea 100 (<1% THC and 10% CBD). Medications were prescribed to patients by clinicians in the National Health Service or by private medical practices.
Patients consumed a mean of 5.15 (±6.8) mg of THC a day and a mean of 171.8 (±153.3) mg of CBD daily.
All patients reported fewer seizures, ranging from a decrease in monthly seizure activity of 62.5% to 100%. The average decrease was 86%.
“It appears that whole-plant cannabis is superior to CBD alone, and the reasons for this are speculative,” Zafar said.
“It is known that THC does have independent antiseizure activity; however, much less is known of the role that other minor cannabinoids and terpenes in the cannabis plant play,” Zafar added.
“There has been some preclinical testing down to suggest they also have antiseizure activity, and so the compounded effects of whole-plant products seem to be working better than just an isolate.”
Commenting on the findings for Medscape Medical News, Tyler Allison, MD, associate professor of pediatrics at Children’s Mercy Kansas City, Missouri, noted that researchers chose patients based on their long-standing use of whole-plant medical cannabis oils, introducing a selection bias.
“The response is still interesting, and I think it needs to be studied further with better parameters in place to reduce bias, but I don’t think it’s fair to evaluate the amount of decrease in seizure frequency when the population studied was only patients who responded to the treatment,” said Allison, who was not involved with the research.
“How many patients tried whole-plant cannabis oil and didn’t find it to be effective or at least more effective than their other antiepileptic treatments?” he asked. “That information is missing and could significantly impact the significance of the study.”
The selection bias and small study group also make it difficult to compare the results to prior studies of isolated CBD that involved larger patient populations, Allison added.
An intention-to-treat, randomized study design that compared a control group treated with a form of isolated CBD product and a second group that received whole-plant cannabis oils would remove that bias, he noted. “Then they could analyze the frequency of seizures in the same way as they did and compare across groups to see if whole-plant cannabis oil shows a reduction in seizure frequency by comparison to a similar drug,” he said.
This is a design Zafar noted he and colleagues are interested in pursuing.
“We are beginning research to understand further the role of minor cannabinoids and terpenes in the treatment of this condition, as we want to further understand why we see a superior clinical effect in whole-plant medicines,” he said.
He added that they also plan to partner with academic and commercial collaborators on additional retrospective and prospective studies on these issues.
The study was unfunded. Zafar has reported no relevant financial relationships. Disclosures for the other authors are listed in the original article. Allison report no relevant conflicts of interest.
BMJ Paediatr Open. Published online December 14, 2021. Full text
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Cannabis oil: 'I've spent £34,000 to keep my epileptic daughter alive'
Laws around the use of medical cannabis were changed in England in 2018 to recognise its benefit for some patients. BBC News spoke to the families of three children with severe epilepsy about the battle they have faced to get the treatment.
'We felt we had to break the law'
Tannine Montgomery says she has spent £34,000 and broken the law to keep her daughter alive.
Six-year-old Indie-Rose, from Clare in Suffolk, has severe epilepsy and can have up to 50 seizures a month without medical cannabis oil.
Since it was legalised two years ago, only a handful of NHS prescriptions have been issued.
The Department of Health and Social Care says more research is needed before it can be routinely prescribed.
Ms Montgomery says her daughter's life has been transformed since she started taking medical cannabis three years ago.
"We went from constant seizures and being in hospital all the time to her being happy and attending school," she says.
It remains illegal to import cannabis oils without a special licence.
Ms Montgomery says the family flew to the Netherlands to obtain it from a Dutch doctor, using a private UK prescription, because the NHS refused to pay for it.
It was costing them £1,500 a month – a cost which would triple if they acquired the licence. Their medication was seized last year at Stansted Airport.
Since Covid-19 restrictions were placed on travel, the family has been unable to fly. They have now run out of the oil, called Bedrolite, and Indie-Rose has started having severe seizures again.
They are also concerned that Brexit will have implications for obtaining it.
What is medical cannabis?
- Medical cannabis is a broad term used by doctors to describe treatments – such as oral tablets, oils and sprays – that have some similar ingredients to recreational cannabis, but will not get you "high"
- These products are made by pharmaceutical companies under the same strict controls as other medications. That means you have to get them on prescription
- Some cannabis-based medicines – such as Epidyolex for epilepsy – have been approved for use by the NHS
- Other products that might claim to be medical cannabis, such as "CBD oil" or hemp oil, are available to buy legally as food supplements from health stores
- There is no guarantee these are of good quality or provide any health benefits and doctors should be consulted before any new medication is taken
Ms Montgomery says: "We have never wanted to break the law. We felt we had to, to keep Indie-Rose alive, but that option is not even open to us at the moment.
"I'm not sleeping and my anxiety is through the roof."
'His quality of life has really improved'
When medical cannabis was legalised, the National Institute for Health and Care Excellence (NICE) produced guidance for the NHS saying there was not enough evidence to recommend cannabis-based medicines for severe epilepsy.
Epidoylex is recommended by NICE, but many families say it has not worked for their children.
The parents of three-year-old Charlie Hughes, from Norwich, are mounting the first legal challenge to the guidelines.
Charlie went from having up to 120 seizures a day to fewer than 20, became more vocal, took an interest in his toys and began to feed himself after taking Bedrolite, his family says.
But doctors say they cannot prescribe it due to the guidelines.
Charlie's family could no longer afford Bedrolite, which was costing them up to £3,000 a month, so they switched to a cheaper version from Israel called Celixir20, which costs them £600 a month.
They were offered Epidoylex on the NHS, but did not want to risk giving it to Charlie after speaking to other families.
His father Matt Hughes said: "Last week he painted his first picture, he is doing so well, his quality of life has really improved. It is so unfair that the burden is on us to fund it."
'Alfie goes months without seizures'
Alfie Dingley, who has a severe and rare form of epilepsy, helped bring about the legalisation of medical cannabis.
In June 2018, the nine-year-old, from Kenilworth, in Warwickshire, became the first person in the UK to be granted a licence for Bedrolite. It is thought only two other people have had it granted since.
It followed a campaign led by his mother Hannah Deacon, who says the NHS prescription changed their lives.
She says: "Alfie goes for months at a time without seizures. It is not a cure, but we are not dealing with life-threatening emergencies every week.
"He was violent and aggressive before and we had no quality of life.
"It needs to be available to everyone. It will save the NHS millions of pounds a year by reducing the time children with severe epilepsy spend in hospital."
Miss Deacon says there has been a "campaign of fear" against medical cannabis which has left doctors scared to prescribe it.
"We are so lucky, but we feel so bad for the other families in this terrible situation," she says.
"It is barbaric what they have had to go through to keep their families safe."
She has set up a charitable organisation called MedCan Support with Matt Hughes to help other families in this situation.
What did the Department for Health say?
A spokesman said Epidoylex could be prescribed on the NHS because there was clear evidence of its "safety, clinical and cost-effectiveness".
He said they sympathised with "patients dealing with challenging conditions" but "more evidence" was needed "to routinely prescribe and fund other treatments on the NHS and we continue to back further research and look at how to minimise the costs of these medicines".