The first cannabis-based medicine has been approved on the NHS in Scotland to treat children with rare forms of epilepsy.
The Scottish Medicines Consortium (SMC) has approved Epidyolex, a cannabidiol medicine for severe epilepsy in children, for use on the NHS.
Epidyolex is approved as an adjunct therapy, alongside clobazam, for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in children aged two years or under.
Making the announcement on Monday 7 September, the SMC said the medicine was considered for NHS use through its patient and clinician engagement (PACE) process, which is used for medicines to treat end-of-life and very rare conditions.
“Through PACE, patient groups and clinicians spoke of the devastating impact Lennox-Gastaut syndrome has on the lives of patients, their family and carers,” the SMC said, noting that the PACE programme also discussed the “debilitating and severe” Dravet syndrome.
Chair of the SMC, Mark MacGregor said: “We know from the powerful testimony given by patients and clinicians in our PACE meetings that our decisions on cannabidiol for both Lennox-Gastaut syndrome and Dravet syndrome will be welcomed, and hopefully provide some relief for patients and their families.”
Epidyolex is manufactured by GW Pharmaceuticals.
Chris Tovey, GW’s chief operating officer, said the SMC’s decision is “proof that cannabis-based medicines can successfully go through extensive randomised placebo-controlled trials and a rigorous SMC evaluation process to reach those patients in need.
“I am especially proud that this is the first time a medicine of this kind has achieved routine reimbursement in Scotland.”
A spokesperson for Epilepsy Scotland said the charity was “delighted”, adding that from “participating in the [SMC’s] PACE process, it is clear that they have listened to patients and clinicians about the profound impact of these severe and difficult-to-treat epilepsy syndromes, and the long-standing need for a specifically approved treatment option”.
Louise Cousins, director of external affairs at the charity Epilepsy Action, said the SMC’s decision was “very welcome”, adding that “new treatment options for severe epilepsies do not come very often”.
However, Cousins said there was “still more work to do”.
“Much-needed clinical trials and alternative access routes should be prioritised so that those people with epilepsy who could benefit from cannabis-based medicines can access them safely on the NHS,” she added.
In December 2019, the National Institute for Health and Care Excellence (NICE) recommended that the NHS pay for the medicine.
The recommendation was made in a technology appraisal which applied to England and Wales. Shortly afterwards, NHS England announced it would fast-track funding for Epidyolex, making it available from 6 January 2019.
In June 2020, the medicine was reclassified from Schedule 2 to Schedule 5 of the Misuse of Drugs Regulations 2001.
New studies examine effects of THC and CBD on stroke
New data suggests both positive and negative effects of cannabis in stroke patients
A new study has shown that pre-treatment CBD may have a neuroprotective effect in stroke patients.
The study aimed to investigate the effect of CBD on oxidative stress and cell death which occurs in ischemic stroke patients.
It revealed that the cannabinoid may reduce the destructive effects of cell damage associated with stroke.
Ischemic strokes are the most common type of stroke. They occur when a blood clot blocks a flow of oxygen or blood to the brain. This takes place in arteries that have been narrowed or blocked over time by fatty deposits (plaques). The most common symptoms of a stroke include facial drooping on one side, not being able to lift your arms and slurred speech.
If this occurs, it is vital that a person be taken to the emergency room immediately.
The National Institute of Health Care and Excellence (NICE) estimate that there are around 100,000 strokes every year in the UK. It is also thought that 1.3 million people live with the effects of a stroke.
Stroke recovery and CBD results
The Study showed that CBD reduced the amount of infarction in those samples which had been given the cannabinoid. Infarction refers to the death of tissue as a result of a lack of blood supply and is commonly due to a blood vessel being obstructed or narrowed.
There were also differences in malondialdehyde level (MDA) – a common marker of oxidative stress – between the brains of the CBD group and the vehicle group.
It also revealed that CBD may help to protect tissue by preventing further damage.
THC and stroke risk
According to findings, cannabis consumers who experience a stroke known as an aneurysmal subarachnoid haemorrhage (aSAH), are twice as likely to develop further complications.
An aSAH occurs when a weakened blood vessel bursts on the surface of the brain leading to bleeding between the brain and tissue that covers it. It can result in neurological disabilities, long-term slurred speech or even death. It is estimated that aSAH affects around eight people per 100,000 of the population each year, accounting for six per cent of first strokes.
The study by the American Stroke Association suggested there is twice the risk of developing delayed cerebral ischemia for cannabis consumers. The researchers analysed data from 1,000 patients who had received treatment for bleeding over a 12 year period. In the group of participants, 36 per cent developed cerebral ischemia and 50 per cent had moderate to severe disabilities.
When comparing the results of patients who tested positive for THC with those who did not, they found cannabis consumers were 2.7 times more likely to develop cerebral ischemia. They were also 2.8 times more likely to develop long-term moderate to severe physical disabilities.
However, compared to those who tested negative for THC, the cannabis group did not have larger aneurysms, higher blood pressures or worse stroke symptoms when admitted to the hospital. They did not have any higher cardiovascular risk factors than the negative group.
Researchers are now conducting further studies in which they hope to better understand if THC can impact aneurysm formation and rupture.
New study shows CBD may prevent Covid-19 infection
Researchers are calling for more trials to determine if CBD could be a preventative or early treatment for the virus.
Researchers are recommending clinical trials to examine if CBD could help to prevent Covid infection after more positive findings have been published.
Researchers from the University of Chicago have reported that CBD may stop the infection of Covid-19 by blocking its ability to replicate in the lungs.
A number of cannabinoids including CBD and THC were tested along with 7-Hydroxycannabidiol (7-OH-CBD) which is thought to be produced when cannabidiol is processed by the body.
The study found that CBD showed a significant negative association with SARS-CoV-2 positive tests in a national sample of patients who were taking high doses of CBD, prescribed for epilepsy.
As a result of their findings, researchers are calling for more clinical trials to determine whether CBD could eventually be used as a preventative or early treatment for the virus.
Covid and CBD study
Researchers treated human lung cells with a non-toxic dose of CBD for two hours before exposing the cells to SARS-CoV-2 and monitoring them for the virus and the viral spike protein.
They found that, above a certain threshold concentration, CBD inhibited the virus’ ability to replicate.
Further investigation found that CBD had the same effect in two other types of cells and for three variants of SARS-CoV-2 in addition to the original strain.
CBD did not affect the ability of SARS-CoV-2 to enter the cell. Instead, CBD was effective at blocking replication early in the infection cycle and six hours after the virus had already infected the cell.
Like all viruses, SARS-CoV-2 affects the host cell by hijacking its gene expression machinery to produce more copies of itself and its viral proteins. This effect can be observed by tracking virus-induced changes in cellular RNAs. High concentrations of CBD almost completely eradicated the expression of viral RNAs.
When it came to the other cannabinoids, CBD was found to be the only potentially potent agent. There was no or limited antiviral activity noted by the similar cannabinoids including THC, CBDA, CBDV, CBC or even CBG.
Marsha Rosner, PhD, professor and senior author of the study said it was a completely unexpected result, she commented: “CBD has anti-inflammatory effects, so we thought that maybe it would stop the second phase of COVID infection involving the immune system, the so-called ‘cytokine storm.’ Surprisingly, it directly inhibited viral replication in lung cells.
She added: “We just wanted to know if CBD would affect the immune system. No one in their right mind would have ever thought that it blocked viral replication, but that’s what it did.”
The researchers do caution that this is not possible with commercially available CBD. The CBD tested was high-purity and also medical grade.
However, Rosner cautioned: “Going to your corner bakery and buying some CBD muffins or gummy bears probably won’t do anything. The commercially available CBD powder we looked at, which was off the shelf and something you could order online, was sometimes surprisingly of high purity but also of inconsistent quality. It is also hard to get into an oral solution that can be absorbed without the special, FDA-approved formulation.”
CBD and Covid studies
This is the second study to be released showing the potential for cannabinoids in Covid management and prevention.
A study by Oregon State University has revealed that the compounds cannabigerolic acid (CBGA) and cannabidiolic acid (CBDA), may have the ability to prevent the virus that causes Covid-19 from entering human cells.
Researchers and scientists, led by Richard van Breedan, found that a pair of cannabinoid acids bind to the SARS-CoV-2 spike protein, blocking a step in the process the virus takes for infection.
Targeting compounds that block the virus-receptor interaction has been helpful for patients with other viral infections such as HIV-1 and hepatitis.
The researchers and scientists identified the two cannabinoid acids through a screening technique, developed previously in van Breeman’s laboratory. The team also screened different botanicals such as red clover, hops, wild yam and three types of liquorice.
Partner of Irish politician “six years seizure free” faces charges over medical cannabis use
John Montaine uses medical cannabis to manage his epilepsy – and is said to be six years seizure free.
The partner of a sitting Irish TD is contesting charges of cannabis possession, saying he uses it medicinally to manage his epilepsy.
John Montaine, who is the partner of Clare Sinn Fein TD Violet Ann Wynne, was charged with the alleged illegal possession of cannabis on February 11, 2021, at his family home, the Irish Independent reported.
Mr Montaine contests the charges and his partner Deputy Wynne has previously spoken publicly about how he uses cannabis medicinally to manage his epilepsy.
Speaking after the initial court hearing in November, Deputy Wynne said in March her partner would be “six years seizure free”.
She went on to say that it has improved his quality of life “100 per cent, without a doubt”.
“There was always some kind of issue – say John having a number of fits within the one month or losing teeth or suffering with severe migraine, but since John has been using the medicinal cannabis, he has had a better quality of life,” Deputy Wynne told the Independent.
She added: “It has also freed myself up. John would have been on disability allowance and I would have had to have been his carer but since using the medicinal cannabis, he doesn’t suffer from any of those issues any longer.”
Medical cannabis is legal in Ireland, but access to a prescription is limited.
Despite legislation being signed off in 2019, Ireland’s Health minister Stephen Donnelly only announced funding for it in January 2021, with the programme only becoming fully operational in November.
Four cannabis-based medicines are expected to be available through the MCAP, to people living with one of three qualifying conditions. These include intractable nausea and vomiting associated with chemotherapy, severe treatment-resistant epilepsy and spasticity associated with multiple sclerosis (MS).
Mr Montaine’s solicitor appeared in Kilrush District Court on behalf of his client this week, where his case was adjourned until 15 March.
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