Within the burgeoning UK cannabis industry there is a tremendous need to build both clinical and real-world evidence to support the efficacy of cannabinoid treatments. Existing cannabis-based medications offer little intellectual property protection due to the difficulty of patenting a specific indication of cannabis. The device used to administer the active pharmaceutical ingredient (API) is the only protection cannabis and pharmaceutical companies can have. Therefore, undertaking a clinical trial with a medication that cannot be patented and can be easily copied, does not make for an attractive proposition for companies in the cannabis space.
This is the primary reason why there is still a distinct lack of clinical evidence to support the power cannabis can have as a medication. The lack of clinical evidence means that real-world evidence becomes more integral to the progression of the medical cannabis industry. Collecting data about the impact cannabinoid products can have on long-term symptoms is imperative to force the medical profession and politicians to see cannabis as a viable alternative to existing treatments, some of which can be detrimental to patient’s long-term health.
The need for real-world evidence inspired the partnership between Alta Flora & Cannacares. With both parties believing that collecting data that proves that over-the-counter CBD patches can have a positive impact for those who use them, is vital in advancing the discussion on how cannabinoid products can help people suffering from debilitating conditions.
Using Alta Flora’s Eva App users can track their symptoms on a daily basis and monitor the medication they are taking. This enables users to review their symptoms over time and see what medications have a positive impact on their life.
Alta Flora & the Eva App
Alta Flora’s purpose is to empower users of the Eva app to take control of their healthcare by having access to their own data. This enables the users of Eva to track their symptoms and cast a critical eye over the progression of their symptoms and the impact their medications are having.
Using Eva means that patients can approach their physician with data that can support their view on what medication they should be using and whether what they have been prescribed actually works. Eva offers a variety of symptom inputs and a vast library of prescription medications. Meaning that all medications a user is taking can be input and over time the impact of each medication can be assessed.
An app like Eva is essential in the development of the medical cannabis industry as it enables users to track the efficacy of medications. By partnering with Cannacares to track the symptoms of those using CBD patches, Eva can collect data on the true effectiveness the CBD patches have on an array of the user’s symptoms.
Tracking symptoms in this manner makes the user more cognizant of their symptoms and the role medication plays in their life.
Cannacares CBD Patches
Cannacares is a direct-to-consumer CBD brand that is the leading distributor of CBD patches in the UK. Having partnered with UK Fibromyalgia to supply CBD patches to subscribers who suffer from the condition, the feedback was incredible. With many users of the patches reporting dramatic improvements and the patch seemingly preferred as a delivery method to more traditional products like CBD oil.
Cannacares elected to focus on transdermal delivery due to the complications of CBD being classified as a novel food, the positive reviews from customers and the number of customers repurchasing on a monthly basis.
A CBD Patch is similar in size to a normal plaster. The user applies the CBD patch to a venous part of the body, such as the top of your arm, inside of your wrist or ankle. The CBD patch is to be kept on for 24 Hours to achieve the maximum effect. Patches are discreet and only have to be applied once a day, so users are less likely to forget to take a dose of CBD.
Body heat activates the patch and causes it to release a small amount of CBD through your skin and into your bloodstream. Think of it like an IV without the needles. When you apply a CBD Patch to your skin, you set up a drug concentration gradient. That means the patch contains a high concentration of CBD, while your skin does not. When a substance like CBD is in high concentration it naturally wants to spread out into the surrounding area. The good thing about transdermal delivery is that it bypasses your lungs, liver and stomach which is where your body filters or breaks down the CBD. This means a higher proportion of the CBD is absorbed into your bloodstream.
Cannacares has a core base of customers that purchase CBD patches on a monthly subscription. Communicating with these customers who regularly purchase patches and educating them about the Eva app and then use it on a regular basis is key to establish a foundation of consistent users of the Eva app.
The Need for Real World Evidence
The primary objective of the Alta Flora & Cannacares partnership is to obtain substantial real-world evidence proving that CBD patches have a positive impact on symptom management for those using them. Using the Eva app to track symptoms across an extended period of time will allow users to analyse the effect the CBD patches have on their symptoms while also investigating the effects other medication they take has on their condition.
Collating this real-world evidence is crucial in establishing a positive correlation between using CBD and symptom relief. Collecting real-world evidence is needed to prove to doctors, scientists and pharmaceutical companies that cannabis does have the potential to offer an alternative to painkillers and opioids. However, cannabis-based solutions will only be taken seriously once there is evidence to substantiate these claims. Heightening the importance of collecting real-world data, to corroborate anecdotal evidence that has existed for centuries.
With the traditional routes to clinical data impaired, real-world evidence offers a solution to the cannabis industry to illustrate cannabinoids have the capacity to substantially improve people’s quality of life and are an alternative treatment option that shouldn’t be a last resort.
First Step Towards a Clinical Study
As users of the Eva app grows, a clear trend will begin to emerge into the effectiveness of using CBD to treat certain symptoms. If the data is supportive of the hypothesis which is using CBD daily can offer symptom relief and an improvement in user’s quality of life. There is then a precedent to conduct a clinical study to further substantiate the claim.
The reality is that clinical studies are extremely expensive, and the initial real-world data needs to be obtained for it to be a viable investment. The Alta Flora & Cannacares partnership seeks to collect this data to determine whether a formal clinical study is viable and have the data to hand to present to clinicians to prove CBD’s potential as an alternate treatment method.
Comparison With Opioids
The Eva app not only tracks a user’s consumption of CBD, but it can track the user’s other medications as well. This means that users can compare the severity of their symptoms while using CBD for a week against a week of taking opioids. This enables a direct comparison between CBD and opioids which is greatly needed to advance the use case of cannabinoids.
Opioids are renowned for having appalling side effects that have ruined countless lives. They are addictive and not a long-term solution for people in pain. Tracking the difference between the side effects of CBD and opioids would provide invaluable data. Using the data, an assessment can be made as to whether opioids actually are more effective over an extended period than CBD.
Due to the pandemic, medical research has been disrupted and resources have been diverted to deal with the unprecedented situation. This has led to delays in collecting data that could drive the cannabis industry forward. Making real-world evidence even more valuable.
The Expense of Medical Cannabis
Medical cannabis is currently extremely expensive in the UK. To obtain a medical cannabis prescription you must have exhausted all recognised treatments for your eligible condition and be seen by a specialist doctor at a private clinic. After all the consultation fees and the monthly cost of a medical cannabis prescription which is approximately £250, a patient’s first prescription is likely to cost in excess of £500. This is simply unaffordable for the majority of people, particularly when you consider those eligible for medical cannabis prescription probably have a condition that means it’s difficult for them to be in full time employment.
This is why collecting real-world evidence using CBD products that cost under £10 is accessible to a larger demographic meaning that more data can be collected. The larger the dataset the more credible the data will be.
The cost of medical cannabis also means that running a clinical study or trial is extraordinarily expensive because the cannabis-based medication is expensive to provide. This makes conducting a trial without charging the participating patients difficult to justify, as without a product with definitive IP protection the cost of a clinical study is unlikely to be recuperated.
This partnership is a first of its kind within the cannabis industry in the UK and the resulting data may demonstrate a clear pathway to conducting a clinical trial and further investigate the efficacy of CBD. Clinical evidence is needed to advance the cannabis industry and ensure patients are receiving treatments that are more suitable to their condition. However, real-world evidence is needed to progress to this stage. The partnership between Alta Flora & Cannacares is a tangible step towards obtaining the data needed for cannabinoids to become a conventional treatment method.
Download on the Play Store: https://play.google.com/store/apps/details?id=com.alta_flora.eva_flutter
Download for iPhone: https://apps.apple.com/app/id1537435291