Millions of people around the world have been introduced to CBD products in the last decade as cannabis continues its journey from “drug to medicine to lifestyle”. Although the molecule was first discovered in 1940 by Roger Adams, it was really GW Pharmaceuticals in the early 2000s and the Beckley Foundation’s research on CBD in 2009 which sparked the current surge of interest. Today, CBD is a multipurpose molecule with potential applications in a wide range of use cases. It can be offered to the consumer in wellness products, fashion brands and even CBD Hummus.
There is another side of CBD which is further along the spectrum towards true medical use by patients. The obvious example is Epidiolex, an FDA-approved pharmaceutical consisting of 99% CBD which is prescribed for childhood epilepsy. Beyond its use as a prescribed drug for neurological conditions, there are online patient communities for severe conditions including arthritis and fibromyalgia discussing Over The Counter (OTC) CBD purchased from the likes of Amazon, Holland & Barrett and Tesco.
The evidence base for CBD
Questions remain around the effectiveness of these products. The FDA has remarked that:
“While the FDA appreciates the information and engagement from numerous stakeholders on CBD-related issues, many evidence gaps remain. Filling these gaps will not be a trivial exercise but will require high-quality data analyzed using robust methods. We believe there is an opportunity to develop better sources of RWD to provide incremental improvements in our scientific understanding of the safety profile of CBD in the general population and, potentially, in specific populations.
We believe that ongoing efforts to systematically collect data on the safety and use of CBD are important and we are engaging with stakeholders to advance this work. At the same time, we see a critical opportunity for the FDA to work collaboratively with partners in government, industry, and academia to develop the foundation for more robust CBD data collection and analysis projects.”
Closer to home there is confusion about CBD and the UK’s Novel Foods legislation. The lack of data is proving to be a real impediment to regulators’ understanding of the market, and the growth of the industry and has been hampered by competing industry interests. The vast range of potential applications of CBD in wellness, medicine, sports, mental health and longevity means that each new use case will need to be assessed by regulators and this is where technology can help.
CBD and Fibromyalgia
Fibromyalgia is a condition which is characterised by pain all over the body, fatigue and mood disturbances (“fibro fog” is a recognised term, first coined by the patients as a symptom). As Dr. Ethan Russo has theorised, Fibromyalgia may be a condition characterised by a lack, or deficiency of endocannabinoids, a theory that may well be proven right as there are increasing numbers of studies showing that patients are finding benefits from cannabinoid products to treat fibromyalgia symptoms. More recently, King’s College London, the University of Liverpool and the Karolinska Institute published evidence that fibromyalgia is an auto-immune condition rather than a condition which originates in the brain which potentially expands the scope of new treatments for patients.
The rapid growth of the CBD market in the UK over the last 5 years has been driven by patients being proactive about taking their self-care into their own hands. Some clinicians and industry observers have doubts about the efficacy of CBD at the kinds of doses found in Over The Counter (OTC) products, and I have also called the UK CBD market an example of “the placebo effect at scale” in the past. With that said, the placebo effect is powerful; the dose-response data for OTC products is largely unknown; and there is significant variation from individual to individual. The presence of other therapeutic molecules, either from whole plant or broad-spectrum products, often adds further complexity.
While the mechanism of action for CBD in the body is yet to be fully understood, what is well established today is that CBD products sold are increasingly being used as alternatives to opioids for treatment of fibromyalgia symptoms. What might explain fibromyalgia patients’ reported positive effects from CBD may well be caused by CBD’s overall immunomodulating effects, as well as the intimate relationship between the endocannabinoid system and the immune system.
The use of CBD for fibromyalgia symptom management appears to offer an alternative to traditional treatment management options, especially when it comes to decreasing pain. However, the lack of insights on the possible effects surrounding CBD ratios and/or different cannabinoid / terpene combinations presents a challenge both for the patients and also the clinicians seeking to incorporate cannabinoids into fibromyalgia treatment.
Community driven medicine; crowdsourced registries
At Alta Flora we build tools which put data into the hands of patients to help with their self-care. Patients can use the mobile app Eva to have data-driven conversations with their doctors, showing which products work with supporting evidence. We do this by working within – and hoping to extend – regulatory approved frameworks to develop new data collection methodologies for assessing the safety and effectiveness of medicines. We work hard to bring researchers and patients together to address unmet needs in the trial process and work towards making a real difference to the lives of the patient communities. We played a role in helping to establish the Project Twenty21 registry and support the MedCannID program by providing insights and, through our connected network of legal professionals, access to legal services which patients can draw on.
One business which has focused heavily on serving the Fibromyalgia patient community is UK based online CBD brand Cannacares. I’d heard from the team there that their patch products were popular, and recommended them to a friend whose mum suffers from Fibromyalgia. She has turned into a regular customer and over time the Cannacares team started seeing this behaviour more broadly – the type of regular purchasing behaviour which leads to high Net Promoter Scores and advocacy that brands strive for. There is now a subscription patch service which is proving popular. By using Eva to gather data from patients, we hope to build a picture of how CBD products work, starting with Cannacares patches. This is the first time that we at Alta Flora have partnered with a company working in the CBD space in this way, although we have been thinking about the nature of integrating cannabis-based products into a digital experience for a couple of years. Here’s an early version of a CBD product scanner which we built as a prototype in 2019:
We have taken this concept into our partnership with Cannacares. When patients enter the Cannacares patch as a cannabis-based product that they are using, Eva automatically sets up tracking for the patch and populates the app with relevant content for the patients. Patients benefit from being able to track how the patch improves their pain and general Quality of Life, and we hope that this data can lead to tailored conversations around their healthcare.
Researchers are interested in understanding the nature of the therapeutic benefit that CBD can deliver to the patients, and so are companies like Cannacares. We are pleased to work with Dr Ilan Lieberman, Consultant Pain Specialist and advisor to Alta Flora. Dr Lieberman has experience of both prescribing medical cannabis to patients with fibromyalgia symptoms, and also recommending the use of OTC CBD products, and is bringing his knowledge and experience to guide the research that we are undertaking.
We believe that this sort of approach to healthcare data collection – a personalised, patient-generated, low-cost, real-time experience which allows the patient to see what works best for them and make informed choices about their health, in collaboration with their healthcare provider. The experience of linking a digital experience to a drug product will become the norm. We are proud to launch this partnership with the Cannacares team. To learn more about Cannacares please visit their website. Their store in Hampstead is also worth checking out if you are close to London and we are excited to share more news about this partnership in the next few months. For Alta Flora community partners and for a more in-depth demo of Eva solution please contact our team at hello@alta-flora for an introduction.
Published July 12, 2021
By Gavin Sathianathan