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New MHRA guidance on real-world data a “step in the right direction”

New guidance, which appears to recognise the value of real-world evidence, has been welcomed by experts.

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MHRA: REAL WORLD DATA

New guidance published by the MHRA, which appears to recognise the value of real-world evidence in clinical trials, has been welcomed as a step in the right direction.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance for researchers hoping to use real-world data sources in clinical studies to support regulatory decisions. 

The guidance outlines how greater use of real-world data for clinical trials could help patients access new medicines sooner and offer a more cost-effective way of running these trials.

However, the MHRA has yet to accept real-world and observational data on its own.

Vast amounts of real-world data are routinely collected from patients using the healthcare system. This includes electronic patient health records, and disease and patient registries.

Information generated from real-world data is rarely used to demonstrate the effectiveness of a medicine before it is approved, with interventions usually subject to randomised control trials (RCTs), which are widely thought of as the “gold standard” in scientific evidence.

Campaigners, doctors and scientists have repeatedly called for regulators to consider real-world evidence when it comes to cannabis-based medicines. RCTs are designed for single-compound pharmaceuticals, making them unsuitable for whole-plant cannabis products, which contain other 500 compounds.

While regulatory bodies have called for more “robust” and “high quality” evidence of safety and efficacy before cannabis medicines can be made more widely available, the UK has a growing body of real-world data through schemes such as Project Twenty21 and the UK Medical Cannabis Patient Registry.

The MHRA said this new guidance follows a consultation with stakeholders from the pharmaceutical industry, academic research, trade associations, patient organisations/charities, healthcare providers and regulatory organisations.

Dr June Raine, MHRA Chief Executive said: “When used in this innovative way, real-world data has the potential to make a huge difference when it comes to bringing medicines through clinical trials to patients.

“With fewer or even no trial-specific visits, consenting trial participants don’t have to travel long distances to get to their appointments. And with fewer logistical hurdles, real world data could make it more feasible for trial sponsors to repurpose existing medicines for new conditions.

“Because of this, and the growing need to find more cost-effective ways of conducting clinical trials, our new series of guidelines focuses on how to use real-world evidence to aid regulatory approval, helping to bring medicines to the patients who need them, sooner.”

Professor Mike Barnes, chair of the UK Cannabis Industry Council and the UK Medical Cannabis Clinicians Society (UKMCCS), said it was welcome news that the body was beginning to recognise the value of real-world evidence.

He commented: ‘I am delighted that at last the MHRA has appreciated the value of real world evidence. Hopefully there is realisation that plant medicines in particular need a full evidence appraisal and are not treated as pharmaceuticals – which they are clearly not. A welcome injection of common sense before Christmas.

“Let’s hope that this new spirit of intelligent appraisal now spreads to NICE and they are able to assess cannabis properly.”

Mags Houston, head of Project Twenty21, which is aiming to build the UK’s largest body of evidence for the safety and efficacy of medical cannabis said: “We definitely feel it’s a step in the right direction – and moves us towards what we’ve been saying for a long while now with regard to the need to take real-world evidence seriously and not rely so heavily on RCTs alone. 

“The research we’ve done with paediatric epilepsy and medical cannabis is a really clear example of this. Project Twenty21 is another example of real-world data that we hope will help influence NICE guidance in the future and open up NHS funding for medical cannabis.”

Michael Lynskey, chief research officer for Drug Science added: “Make no mistake, real-world data is extremely valuable, especially when one considers the obstacles that prevent researchers from conducting traditional, large-scale trials, such as the enormous and restrictive costs.

“The MHRA’s guidance is a welcome step in the right direction. It will hopefully lead to increased acceptance of evidence derived from real world data, including observational and registry data on the safety and effectiveness of novel treatments. 

“Such data from our own Project Twenty 21, which indicates the real world effectiveness of medicinal cannabis for improving general health and quality of life, illustrate why this progress matters.”

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New studies examine effects of THC and CBD on stroke

New data suggests both positive and negative effects of cannabis in stroke patients

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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.

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THC and stroke risk

Another recent study examined the effect that tetrahydrocannabinol (THC) could have on strokes. It found that it may increase the risk of a certain type of stroke among cannabis consumers.

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.

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Researchers are now conducting further studies in which they hope to better understand if THC can impact aneurysm formation and rupture.

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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.

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Covid: A covid infection

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- Covid infection

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.

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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.

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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.

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Could this natural compound – produced by the human body – be a substitute for CBD?

Studies show PEA may act in a similar way to CBD by interacting with our endocannabinoid system

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PEA: A bowl of soybeans containing PEA
PEA is found naturally in the body and also in soybean and egg yolks

A new review suggests that Palmitoylethanolamide (PEA) may be a safer, therapeutic alternative to CBD. But what is it and how could it help?

The review titled, ‘A Potential Alternative to Cannabidiol‘ examined if PEA could be a safer alternative to certain cannabinoids, in particular for those who may be concerned about THC in cannabis.

PEA is a chemical made from fat, which is found naturally in foods such as egg yolks and peanuts, as well as in the human body.

The report was commissioned by Gencor Pacific, a company which uses PEA in its products for sleep and sports recovery.

Researchers stated that the ambiguity surrounding the regulatory status and the insufficient studies on CBD’s efficacy, may present an opportunity for PEA. They cited a demand for alternative compounds that produce similar results but have a more defined regulatory status.

The authors wrote: “CBD… is reported to have beneficial medicinal properties including analgesic, neuroprotective, anxiolytic, anticonvulsant, and antipsychotic activities, while apparently lacking the toxicity of THC.

“With proven efficacy in several therapeutic areas, its safety and tolerability profile and the development of formulations that maximise its bioavailability, PEA is a promising alternative to CBD.”

They added: “The therapeutic actions of CBD and PEA overlap in their biochemical roles in humans. There is a need for further investigation of their pharmacokinetics, specifically regarding definitive bioavailability and volume of distribution, and safety and efficacy when used long-term in diseased and healthy populations. At this time PEA’s safety, tolerability, consistency and regulatory profile confer certain advantages.”

PEA: A compound found naturally in the body and also in soybean and egg yolks

PEA is found naturally in the body and also in soybean and egg yolks

What is PEA?

Palmitoylethanolamide (PEA) is a lipid mediator which may have anti-inflammatory, analgesic and neuroprotective benefits. It also appears to work with the endocannabinoid system in a similar way to CBD while providing the same benefits.

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It is structured in a similar way to the bliss molecule, anandamide, and may enhance its effects in the body. Anandamide is an endogenous cannabinoid known to act upon the CB1 receptors in our endocannabinoid system. CBD also affects the CB1 receptors although it is not fully understood how this happens.

PEA may also stop the production of inflammation in the body which makes it perfect for sports relief topicals. It acts as an anti-inflammatory and analgesic by binding to the TRPV-1 channel, CB1 and CB2 receptors.

Another difference between CBD and PEA is that we do not naturally produce cannabidiol in our bodies. However, PEA is found naturally in our cells, tissues, brain and fluids. It can also be found in foods such as egg yolk or soybean lecithin. PEA has been associated with relief for the common cold, eczema, influenza and neurodegenerative disorders

Why do I need an alternative to CBD?

While the study presents PEA as an alternative to CBD, it doesn’t have to be.

It can be something that is boosted naturally by eating more foods that contain it. CBD and PEA work in similar ways but may have slight differences in how they interact with receptors.

Where it may work as a substitution is for people who struggle with allergies to different terpenes in cannabis or dislike taking something related to the plant. If someone is worried about tetrahydrocannabinol (THC) appearing in drug tests if they take CBD then potentially, this may present an alternative.

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